Oculis (Nasdaq: OCS) sets 2026 AGM, details late-stage pipeline and expanded share capital tools
Rhea-AI Filing Summary
Oculis Holding AG is calling shareholders to its 2026 Annual General Meeting on May 13, 2026 in Zug, Switzerland, with an in-person meeting and broadcast.
The agenda covers approval of the 2025 annual and consolidated financial statements, carrying forward a balance sheet loss of CHF 80,247,000, and granting discharge to the board and executive committee. Shareholders will vote on re-electing eight directors, electing a new director, appointing compensation committee members, re-electing PricewaterhouseCoopers as auditor, and electing Blum & Partner AG as independent proxy.
Compensation proposals include up to USD 572,000 fixed and USD 2,150,000 equity-based pay for the board, and up to USD 2,500,000 fixed, USD 1,800,000 variable, and USD 18,000,000 equity-based compensation for the executive committee. The board also seeks to increase the capital band so it can issue up to 31,020,888 additional shares and to expand conditional share capital for employee plans to 12,677,700 shares.
A business update highlights three late-stage programs: OCS-01 eye drops for diabetic macular edema with Phase 3 DIAMOND trial readouts expected in June 2026 and a planned U.S. NDA submission in Q4 2026; Licaminlimab for dry eye disease in the PREDICT-1 registrational trial with topline data expected around late 2026; and Privosegtor, which has Breakthrough Therapy, Orphan Drug and PRIME designations and is entering the PIONEER registrational program for optic neuritis and NAION. Oculis reports oversubscribed equity financings exceeding $200 million in 2025 and is targeting disease areas that together represent estimated market opportunities of over $30 billion.
Positive
- None.
Negative
- Potential dilution from expanded share authorities: The board seeks approval to increase the capital band so it can issue up to 31,020,888 additional shares and to expand conditional share capital for employee plans to 12,677,700 shares, which together represent a significant capacity for future equity issuance.
Insights
Oculis pairs an AGM package of share-capital flexibility and pay votes with an update on a heavily de‑risked late-stage pipeline.
Oculis outlines three advanced programs: OCS‑01 for diabetic macular edema with Phase 3 DIAMOND readouts expected in Q2 2026 and a planned NDA in Q4 2026, Licaminlimab in the PREDICT‑1 registrational trial for dry eye disease with topline data around late 2026, and Privosegtor in the PIONEER registrational program for optic neuritis and NAION, backed by Breakthrough Therapy, Orphan Drug and PRIME designations.
On the financing side, oversubscribed equity raises above $200 million in 2025 support these programs but are complemented by structural tools that can add future dilution. The board requests an expanded capital band authorizing up to 31,020,888 additional registered shares and a larger conditional pool of 12,677,700 shares for employee plans, on top of an issued capital of CHF 620,417.76 as of March 31, 2026.
The AGM also bundles standard Swiss corporate items: approval of a CHF 33,670,000 net loss for 2025 and accumulated losses of CHF 80,247,000 to be carried forward, re-election of directors and auditor, appointment of an independent proxy, and binding maxima for fixed, variable and equity-based compensation. The combination of sizable prospective share issuance authority and clear late‑stage clinical milestones frames both the company’s growth ambitions and its reliance on equity-funded development.
Key Figures
Key Terms
capital band financial
Breakthrough Therapy designation regulatory
Orphan Drug designation regulatory
PRIME (PRIority MEdicines) designation regulatory
independent proxy regulatory
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Month of April 2026
(Commission File No. 001-41636)
Oculis Holding AG
(Translation of registrant's name into English)
Bahnhofstrasse 20
CH-6300
Zug, Switzerland
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ |
Form 40-F ☐ |
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On April 21, 2026, Oculis Holding AG (the “Registrant”) published the invitation to its 2026 Annual General Meeting to be held on May 13, 2026 at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 6:00 a.m. EDT / 10:00 a.m. GMT / 12:00 p.m. CEST. The press release, the Invitation to the 2026 Annual General Meeting, the Annual General Meeting Proxy Card, and the 2025 Annual Report of the Registrant are furnished hereto as Exhibits 99.1, 99.2, 99.3 and 99.4, respectively. The results from the 2025 Annual General Meeting can be found on the Registrant's website at https://investors.oculis.com/events/event-details/2025-annual-general-meeting.
EXHIBIT INDEX
Exhibit |
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Description |
99.1 |
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Press Release dated April 21, 2026 |
99.2 |
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Invitation to the 2026 Annual General Meeting of Shareholders |
99.3 |
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Annual General Meeting Proxy Card |
99.4 |
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2025 Annual Report |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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OCULIS HOLDING AG |
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Date: April 21, 2026 |
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By: |
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/s/ Sylvia Cheung |
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Chief Financial Officer |
Exhibit 99.1
Oculis Publishes Invitation to the Annual General Meeting
ZUG, Switzerland, April 21, 2026 – Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis”), today published the invitation to the 2026 Annual General Meeting, which will be held on May 13, 2026 at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 6:00 a.m. EDT / 10:00 a.m. GMT / 12:00 p.m. CEST.
The 2026 Annual General Meeting will be held in-person and broadcast, with no option for virtual participation. To join the broadcast, please use the following link: https://meetings.lumiconnect.com/100-352-684-319.
Information pertaining to the 2026 Annual General Meeting, including meeting materials, can be accessed on our website at https://investors.oculis.com/events-presentations.
Shareholders holding shares traded on Nasdaq US will receive physical proxy materials and voting instructions.
Shareholders holding shares traded on Nasdaq Iceland will not receive physical proxy materials and may instead submit their voting instructions electronically via the Lumi AGM Mobile Platform provided by Lumi Global. To register for voting of your shares traded on Nasdaq Iceland, please access the following link: www.lumiconnect.com/events/oculisagm2026.
Shareholder Information Session
Oculis will host an information session for all shareholders on Monday, May 11, 2026 at Hilton Reykjavík Nordica, Sudurlandsbraut 2, 108 Reykjavík, Iceland from 12:00-1:00 p.m. EDT / 4:00-5:00 p.m. GMT / 6:00-7:00 p.m. CEST, during which members of management will provide an overview of the 2026 Annual General Meeting proposals and answer questions from shareholders. To attend the shareholder information session either in person or virtually, please register via the following link: https://reg.lumiengage.com/oculis-agm-2026/informationsession. The webcast of the virtual information session will be available following the event by visiting our website at https://investors.oculis.com/events-presentations.
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based
Exhibit 99.1
approach to drive precision medicine in dry eye disease (DED); and Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases. Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contacts
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com
Exhibit 99.2
Zug, 21 April 2026
To the Shareholders of Oculis Holding AG, in Zug, SWITZERLAND
Invitation to the
2026 Annual General Meeting of Shareholders
Dear Shareholders,
On behalf of Oculis Holding AG ("Oculis"), we are pleased to invite you to our third annual general meeting as a public company, to be held on 13 May 2026, at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 6:00 a.m. EDT / 10:00 a.m. GMT / 12:00 p.m. CEST (the "2026 Annual General Meeting").
2025 was a transformational year for Oculis. The milestones achieved, thanks to your sustained support, have positioned Oculis to unlock substantial value in 2026 and beyond by maintaining rigorous and disciplined execution of our plans and expanding our strategic footprint in neuro-ophthalmology, an area of high unmet medical need.
We entered 2025 with strong momentum, and our three core clinical programs—OCS-01 for diabetic macular edema, Licaminlimab (OCS-02) for dry eye disease, and Privosegtor (OCS-05) for optic neuritis and beyond—have advanced meaningfully. Taken together, these programs have the potential to redefine how a range of serious ocular and neuro-ophthalmic conditions are treated.
2025 featured significant clinical progress across Oculis late-stage portfolio
OCS-01: Advancing Toward the Potential First Eye Drop Treatment for Diabetic Macular Edema
Our lead program, OCS-01, continues to progress on schedule, and we are pleased to report that enrollment in both trials, DIAMOND-1 and -2, has been completed with over 800 patients randomized across 119 clinical centers globally. This achievement reflects strong support from the medical community and patients for a potential non-invasive topical alternative to the current standard of care. Currently, in the U.S., for example, only a small portion of the 1.8 million people diagnosed with the disease are successfully treated, and we estimate that a staggering ~1 million DME patients are either untreated with mild to moderate vision impairments or are inadequately responding to the current standard of care. OCS-01 is strategically designed to capture this 'lost' majority by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections. The topline results from both DIAMOND Phase 3 trials are expected in June 2026, with a subsequent New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) planned for Q4 2026 following a positive readout.
Licaminlimab (OCS-02): Advancing Precision Medicine in Dry Eye Disease
Licaminlimab, a potentially first-in-class anti-TNFα eye drop, is poised to pioneer a new genotype-based development paradigm in ophthalmology. The Licaminlimab Phase 2b RELIEF study demonstrated a greater treatment effect in patients carrying a specific TNFR1 genotype. This profound improvement was observed in two consecutive Phase 2 trials, one in symptoms and one
Exhibit 99.3
SCAN TO VIEW MATERIALS & VOTEOCULIS HOLDING AGBAHNHOFSTRASSE 206300 ZUGSWITZERLANDVOTE BY INTERNET - www.proxyvote.com or scan the QR Barcode aboveUse the Internet to transmit your voting instructions and for electronic delivery of information up until 11:59 p.m. Eastern Time on May 11, 2026. Have your proxy card in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form.ELECTRONIC DELIVERY OF FUTURE PROXY MATERIALSIf you would like to reduce the costs incurred by our company in mailing proxy materials, you can consent to receiving all future proxy statements, proxy cards and annual reports electronically via e-mail or the Internet. To sign up for electronic delivery, please follow the instructions above to vote using the Internet and, when prompted, indicate that you agree to receive or access proxy materials electronically in future years.VOTE BY PHONE - 1-800-690-6903Use any touch-tone telephone to transmit your voting instructions up until 11:59 p.m. Eastern Time on May 11, 2026. Have your proxy card in hand when you call and then follow the instructions.VOTE BY MAILMark, sign and date your proxy card and return it in the postage-paid envelope we have provided or return it to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717.V95666-P49298OCULIS HOLDING AGTHE BOARD OF DIRECTORS OF THE COMPANY RECOMMENDS THAT YOU VOTE YOUR SHARESFORAGENDA ITEMS 1-12For AgainstAbstain!1.APPROVAL OF THE 2025 ANNUAL REPORT INCLUDING THE 2025 ANNUAL (STATUTORY) FINANCIAL STATEMENTS AND THE 2025 CONSOLIDATED FINANCIAL STATEMENTS!!!For AgainstAbstain2.ALLOCATION OF BALANCE SHEET RESULTS 20253.DISCHARGE TO THE MEMBERS OF THE BOARD OF DIRECTORS AND THE EXECUTIVE COMMITTEE6.RE-ELECTION OF PRICEWATERHOUSECOOPERS SA (LAUSANNE) AS STATUTORY AUDITORS4.ELECTION OF THE CHAIRPERSON AND THE OTHER MEMBERS OF THE BOARD OF DIRECTORS!!!7.ELECTION OF BLUM & PARTNER AG (ZUG) AS INDEPENDENT PROXY4.1Re-election of Anthony Rosenberg as Member and Chairperson of the Board of Directors8.COMPENSATION FOR THE NON-EXECUTIVE MEMBERS OF THE BOARD OF DIRECTORS4.2Re-election of Christina Ackermann8.1Vote on Total Fixed (Non-Performance-Related) Compensation for Non-Executive Members of the Board of Directors until the end of the Company's 2027 Annual General Meeting!!!!!4.3Re-election of Lionel Carnot8.2Vote on Equity or Equity Based Compensation for Non-Executive Members of the Board of Directors until the end of the Company's 2027 Annual General Meeting!!!4.4Re-election of Arshad M. Khanani9.COMPENSATION FOR THE MEMBERS OF THE EXECUTIVE COMMITTEE!!!4.5Re-election of Martijn Kleijwegt9.1Vote on Fixed (Non-Performance-Related) Compensation for Members of the Executive Committee payable in 20279.2Vote on variable Compensation for Members of the Executive Committee payable in 20279.3Vote on Equity Based Compensation for Members of the Executive Committee for 2027!!!4.6Re-election of Geraldine O'Keeffe!4.7Re-election of Riad Sherif!10.NON-BINDING ADVISORY VOTE ON THE 2025 COMPENSATION REPORT4.8Re-election of Robert K. Warner!!4.9 Election of Gregory D. Perry5.ELECTION OF THE MEMBERS OF THE COMPENSATION COMMITTEE!!!11.INCREASE AND AMENDMENT OF CAPITAL BAND*5.1Re-election of Lionel Carnot12.INCREASE OF CONDITIONAL SHARE CAPITAL FOR EMPLOYEE BENEFIT PLANS*!5.2Election of Geraldine O'Keeffe*Please mark either Foror Against because abstentions have the legal effect ofAgainst .5.3Election of Gregory D. PerryNote: Please sign exactly as name appears hereon. When shares are held by joint owners, both should sign. When signing as attorney, executor, administrator, trustee, guardian, or corporate officer, please give title as such.
Important Notice Regarding the Internet Availability of Proxy Materials for the 2026Annual General Meeting of Shareholders:The Meeting Invitation is available at www.proxyvote.comV95667-P49298OCULIS HOLDING AGANNUAL GENERAL MEETING OF SHAREHOLDERSMAY 13, 2026 12:00 PM CEST / 6:00 AM EDTTHIS PROXY IS SOLICITED ON BEHALF OF THE BOARD OF DIRECTORSThe undersigned appoints the current independent proxy of the Company, PST Legal AG, as proxy, and authorizes them to represent and to vote, as designated on the reverse hereof, all of the ordinary shares of Oculis Holding AG ( Oculis ), held of record by the undersigned at the close of business on April 15, 2026 at the 2026 Annual General Meeting of Shareholders of Oculis to be held on May 13, 2026, or at any adjournment thereof.THIS PROXY WHEN PROPERLY EXECUTED WILL BE VOTED AS INDICATED. IF NO CONTRARY INDICATION IS MADE, THE PROXY WILL BE VOTED IN FAVOR OF AGENDA ITEMS 1-12, AND IN ACCORDANCE WITH THE JUDGMENT OF THE PROXY NAMED HEREIN ON ANY OTHER MATTERS THAT MAY PROPERLY COME BEFORE THE ANNUAL GENERAL MEETING. THIS PROXY IS SOLICITED ON BEHALF OF THE BOARD OF DIRECTORS.(Continued and to be marked, dated and signed, on the other side)
Exhibit 99.4
Oculis Holding AG
2025 Annual Report
Table of Contents
Letter to Shareholders |
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1 |
Business Update |
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4 |
Financial Review |
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44 |
Corporate Governance |
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58 |
Report of the Statutory Auditor to the General Meeting on the Consolidated Financial Statements 2025 |
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72 |
IFRS Consolidated Financial Statements as of and for the year ended December 31, 2025 |
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79 |
Report of the Statutory Auditor to the General Meeting on the Financial Statements 2025 |
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116 |
Statutory Financial Statements of Oculis Holding AG for the period ending December 31, 2025 |
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121 |
Report of the Statutory Auditor to the General Meeting on the Compensation Report 2025 |
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135 |
Compensation Report 2025 of Oculis Holding AG |
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139 |
Forward Looking Statements |
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153 |
1
Dear Shareholders,
On behalf of Oculis Holding AG ("Oculis"), we are pleased to invite you to our third annual general meeting as a public company, to be held on May 13, 2026, at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 6:00 a.m. EDT / 10:00 a.m. GMT / 12:00 p.m. CEST (the "2026 Annual General Meeting").
2025 was a transformational year for Oculis. The milestones achieved, thanks to your sustained support, have positioned Oculis to unlock substantial value in 2026 and beyond by maintaining rigorous and disciplined execution of our plans and expanding our strategic footprint in neuro-ophthalmology, an area of high unmet medical need.
We entered 2025 with strong momentum, and our three core clinical programs—OCS-01 for diabetic macular edema, Licaminlimab (OCS-02) for dry eye disease, and Privosegtor (OCS-05) for optic neuritis and beyond—have advanced meaningfully. Taken together, these programs have the potential to redefine how a range of serious ocular and neuro-ophthalmic conditions are treated.
2025 featured significant clinical progress across Oculis late-stage portfolio
OCS-01: Advancing Toward the Potential First Eye Drop Treatment for Diabetic Macular Edema
Our lead program, OCS-01, continues to progress on schedule, and we are pleased to report that enrollment in both trials, DIAMOND-1 and -2, have been completed with over 800 patients randomized across 119 clinical centers globally. This achievement reflects strong support from the medical community and patients for a potential non-invasive topical alternative to the current standard of care. Currently, in the U.S., for example, only a small portion of the 1.8 million people diagnosed with the disease are successfully treated, and we estimate that a staggering ~1 million DME patients are either untreated with mild to moderate vision impairments or are inadequately responding to the current standard of care. OCS-01 is strategically designed to capture this 'lost' majority by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections. The topline results from both DIAMOND Phase 3 trials are expected in June 2026, with a subsequent New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) planned for Q4 2026 following a positive readout.
Licaminlimab (OCS-02): Advancing Precision Medicine in Dry Eye Disease
Licaminlimab, a potentially first-in-class anti-TNFα eye drop, is poised to pioneer a new genotype-based development paradigm in ophthalmology. The Licaminlimab Phase 2b RELIEF study demonstrated a greater treatment effect in patients carrying a specific TNFR1 genotype. This profound improvement was observed in two consecutive Phase 2 trials, one in symptoms and one in signs of DED, showing a five to seven-fold greater response in patients with this specific genotype. In the U.S. alone, approximately 10 million patients suffer from moderate to severe DED. Current disease management relies on trial-and-error, and only 13% of patients experience sustained relief, leading to 85-90% discontinuation rate within the first 6 months, underscoring the strong need for a targeted, effective treatment approach. Licaminlimab has the potential to transform the current treatment paradigm by providing a precision medicine approach with efficacy, rapid onset of action, and a comfort level comparable to artificial tears. In 2025, following a successful FDA alignment meeting, we initiated the registrational PREDICT-1 trial in DED, with topline results anticipated around late 2026.
Privosegtor (OCS-05): Pioneering a New Era of Neuroprotection
The most notable development of 2025 has been the rapid acceleration of Privosegtor, our novel neuroprotective candidate. Following the positive topline readout from the Phase 2 ACUITY trial in optic neuritis (ON) announced earlier this year, we have moved decisively to expand and advance the program. The ACUITY data demonstrated clinically meaningful improvement in low-contrast visual acuity, together with objective evidence of anatomical neuroprotection—including preservation of retinal ganglion cells and axons, as well as significantly reduced levels of neurofilament light chain, a well-established biomarker of neuro-axonal damage associated with conditions such as multiple sclerosis. These results are consistent with a mechanism of action that could have broad relevance across multiple neuro-axonal diseases.
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The robust ACUITY trial outcome and our regulatory discussions led to the FDA granting Privosegtor Breakthrough Therapy designation for the treatment of optic neuritis and the launch of the PIONEER registrational program in optic neuropathies, indications with a high unmet medical need and no approved neuroprotective treatments, collectively representing an estimated U.S. market opportunity of over $7 billion for Privosegtor.
The concurrent execution of the PIONEER trials in optic neuropathies is designed to generate operational synergies, improve cost efficiency, and accelerate Privosegtor's overall development timeline. Privosegtor has received Orphan Drug designation from both the FDA and the European Medicines Agency for ON, which we believe underscores the significance of this program. We are also evaluating Privosegtor as a potential treatment for acute relapses in multiple sclerosis patients—a further demonstration of the breadth of this candidate's future potential.
Most recently, Privosegtor was granted PRIME (PRIority MEdicines) designation by the EMA (European Medicines Agency), a highly selective process offered by the agency to enhance support and accelerate assessment for promising therapies, and for faster patient access targeting high unmet medical needs. This reinforces the broad and strong support from regulators across the world for Privosegtor in optic neuritis.
Focus for 2026: Unlocking Value in Ophthalmology and Neuro-ophthalmology
Our financial position is strong, thanks to oversubscribed equity financings exceeding $200 million in 2025, which provides a solid foundation for developing innovative therapies and bringing them to market.
As 2025 was characterized by operational excellence and transformation, 2026 is planned as a year of landmark accomplishments, with major registrational milestones anticipated: the DIAMOND-1 and DIAMOND-2 trials readout with OCS-01 in DME anticipated in June, the PREDICT-1 trial results for Licaminlimab in DED planned around late 2026, and the initiation of the PIONEER program trials. We are pursuing substantial unmet medical need which represent estimated potential market opportunities of over $30 billion.
On behalf of the Oculis team and the board of directors, we are grateful for the continued confidence you have placed in Oculis. Our mission—to preserve and restore vision for patients around the world—remains the driving force behind everything we do, and we look forward to delivering on that mission in the year ahead.
Sincerely,
Riad Sherif, M.D.
Chief Executive Officer
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Business Update
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Information on the Company
A. History and Development of the Company
We are a stock corporation (Aktiengesellschaft) that was incorporated under the laws of Switzerland on October 31, 2022. We are registered with the commercial register of the Canton of Zug under company registration number CHE-396.695.611. The mailing address of our principal executive office is Oculis Holding AG, Bahnhofstrasse 20, CH-6300, Zug, Switzerland. Neither our articles of association nor the operation of law limit our duration.
Certain additional information about the Company is included in Item B. “Information on the Company—Business Overview” of this section "Business Update." The Company is subject to certain of the informational filing requirements of the Exchange Act. Since the Company is a “foreign private issuer,” it is exempt from the rules and regulations under the Exchange Act prescribing the furnishing and content of proxy statements, and the officers, directors and principal shareholders of the Company are exempt from the reporting and “short-swing” profit recovery provisions contained in Section 16 of the Exchange Act with respect to their purchase and sale of ordinary shares. In addition, the Company is not required to file reports and financial statements with the SEC as frequently or as promptly as U.S. public companies whose securities are registered under the Exchange Act. However, the Company is required to file with the SEC an Annual Report on Form 20-F containing financial statements audited by an independent accounting firm. The SEC also maintains a website at http://www.sec.gov that contains reports and other information that the Company files with or furnishes electronically to the SEC.
Our telephone number is +41-41-711-3960 and our website is www.oculis.com.
B. Business Overview
Company Overview
We are a global late clinical-stage biopharmaceutical company, headquartered in Switzerland with operations in Switzerland, the U.S. and Iceland. We have substantial expertise in therapeutics for the treatment of neuro-ophthalmic and ophthalmic diseases. We are engaged in developing innovative drug candidates that embrace the potential to address significant unmet medical needs. We intend to become a global leader in neuro-ophthalmic and ophthalmic therapeutics to realize this mission.
Our pipeline currently includes three clinical-stage therapeutic candidates: OCS-01, Licaminlimab (OCS-02) and Privosegtor (OCS-05). OCS-01, the first candidate we developed using our OPTIREACH technology, is an eye drop candidate which aims to be the first non-invasive topical treatment for DME. It is presently being evaluated in two ongoing Phase 3 clinical trials for DME, with topline results expected in the second quarter of 2026. Licaminlimab is a product candidate we added to our pipeline in 2018 and are developing for the treatment of keratoconjunctivitis sicca, or dry eye disease (“DED”), with a precision medicine approach. After a successful FDA meeting in the first quarter of 2025, we initiated the PREDICT-1 registrational Phase 2/3 trial with a genotype-based approach to investigate Licaminlimab in DED in the fourth quarter of 2025 for which topline results are expected in the fourth quarter of 2026. Privosegtor is a neuroprotective candidate we added to our pipeline in 2022 which has the potential to become a novel therapy for optic neuritis (“ON”) and non-arteritic anterior ischemic optic neuropathy (“NAION”) with broad potential for other neuro-ophthalmic and neurological diseases and beyond. Following a successful meeting with the FDA in the third quarter of 2025, we advanced Privosegtor into a registrational program called PIONEER for ON and NAION.
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Summary of Our Pipeline
OCS-01 is an eye drop based on the OPTIREACH® technology developed to reach the retina, Licaminlimab is an anti-TNFα eye drop candidate designed to treat ocular inflammation and Privosegtor is a peptoid small molecule with a novel mode of action promoting neuroaxonal survival.
Utilizing our internal core competency in formulation discovery and drug development capabilities, together with extensive licensing, collaboration and acquisition activities, we have assembled a pipeline of innovative and highly differentiated development candidates that include three late-stage clinical candidates.
OCS-01
Developed from our proprietary technology, OCS-01 is an OPTIREACH® formulation of high-concentration dexamethasone. It is being developed as an eye drop to offer a non-invasive treatment alternative for diabetic macular edema (”DME”). This route of administration may enable access to treatment in the early stages of the disease and could be used to treat patients inadequately controlled with the current standard of care in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye. OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option.
Given the current burden of therapy, FDA-approved therapeutics are not widely used for early disease intervention. It has been reported that 60% of DME patients are not treated 12 months after the diagnosis (IRIS data base June 2023), despite some patients experiencing a deterioration in vision, if left untreated. In addition, approximately 40% of patients treated with anti-VEGF intravitreal injections have an inadequate response at 12 weeks.
OCS-01 is designed to deliver therapeutic levels of drug to the retina via an eye drop, a route of administration for DME treatment that may enable earlier intervention and thereby significantly increase the proportion of patients being treated, as well as increase the prescribing physician base by providing a treatment option to general ophthalmologists. An eye drop treatment would also provide a new treatment option for patients with inadequate response to the current invasive standard of care. We are currently not aware of the existence of any other eye drop treatment for DME which is in a similar or more advanced stage of active clinical development; however, we cannot guarantee that OCS-01 will receive regulatory approval.
Following the positive DIAMOND Stage 1 trial outcome, we advanced the OCS-01 development program for DME into two global pivotal Phase 3 clinical trials, DIAMOND-1 and DIAMOND-2, for the treatment of DME. We completed enrollment for both trials in April 2025 with over 800 patients in 119 clinical sites. The topline results from the two
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DIAMOND trials are expected in the second quarter of 2026. If the results are positive, we plan to submit an NDA to the FDA for OCS-01 for the treatment of DME in the fourth quarter of 2026.
The total U.S. prevalence of DME in 2024 was estimated at 3.0 million, with the diagnosed U.S. prevalence estimated at 1.8 million by the Decision Resources Group DME Landscape November 2020 report. The same report estimates that 1.0 million U.S. DME patients were treated with drugs in 2024, leaving 0.9 million U.S. patients diagnosed but untreated. These 0.9 million patients are a key addressable market segment for OCS-01, especially for those with mild visual impairment. Additionally, OCS-01 is also intended to address the market segment of patients with inadequate response to anti-VEGF therapy. A study published in the American Journal of Ophthalmology in 2016 found that nearly 40% of patients treated with anti-VEGF therapy had inadequate responses at 12 weeks. By applying this figure to the number of treated U.S. patients, we estimate that inadequate response occurs in approximately 0.4 million patients. In total, we estimate that 1.3 million DME patients in the United States are addressable by OCS-01, with the highest unmet needs in the patients currently being observed with mild visual impairments (approximately 0.6 million DME patients), and the inadequately controlled patients with the current standard of care (approximately 0.4 million DME patients).
Licaminlimab
We are also advancing the clinical development of Licaminlimab, a next-generation biologic treatment for ocular inflammation, specifically as a treatment for DED. Differentiating Licaminlimab is its use of a single chain antibody fragment specifically designed for topical delivery in ophthalmology, which are directed against the cytokine human tumor necrosis factor alpha (“TNFα”). Furthermore, the small size of the fragment enables the topical delivery of an anti-TNFα construct with increased concentrations and enhanced ocular tissue penetration. The anti-inflammatory and anti-necrotic properties of therapeutics inhibiting TNFα activity are well established with anti-TNF pharmaceuticals already approved as systemic treatments for ocular disease.
While Licaminlimab could be developed for all comers with DED, we are advancing the development of Licaminlimab in conjunction with the development of a novel genetic biomarker intended to identify patients who are more likely to have a greater response to Licaminlimab therapy, and believe this precision medicine approach may allow the candidate to deliver superior outcomes in these patients if approved.
Two Phase 2 clinical trials in patients with symptoms of DED were conducted (the first with the predecessor of Licaminlimab, and the second with Licaminlimab). Topical ocular administration of Licaminlimab demonstrated improvements in the global ocular discomfort score versus vehicle in patients with DED, as well as being well tolerated in both studies. In June 2024, we announced positive topline results from the Phase 2b RELIEF study evaluating Licaminlimab as a treatment for moderate-to-severe DED in which Licaminlimab was well tolerated, similar to vehicle. Additionally, improvements in multiple sign efficacy endpoints were observed in the full population and with predictive and more pronounced effects in patients with a specific TNFR1 gene variant as identified in the prior successful Phase 2 symptoms trial. We have consulted with the FDA during the first quarter of 2025, and in the fourth quarter of 2025 initiated PREDICT-1, a registrational Phase 2/3 trial with a genotype-based approach to investigate Licaminlimab in DED. The intent is to drive a precision medicine approach in DED, for the very first time, and topline results from the PREDICT-1 trial are anticipated in the fourth quarter of 2026.
DED is a common condition estimated to impact more than 110 million people in the G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan), including 40 million people in the U.S. alone. Of the about 20 million patients diagnosed with DED in the U.S. alone, about 10 million are considered to have moderate to severe disease and therefore need a treatment. It is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state. With currently available treatment options, eye care practitioners often need to adapt their treatment strategies and rely on ‘trial and error’ to find the best approach for each patient. Despite currently available treatments, the DED patient population remains underserved with only 13% of patients receiving prescription treatment, primarily anti-inflammatory medications. Unfortunately, the vast majority (87%) do not feel that their chronic DED is well-managed, which highlights a high level of dissatisfaction among patients. Furthermore, given the heterogenicity of the DED patient population, there is a need for more personalized treatment approaches to improve outcomes for patients. Licaminlimab is designed to address this significant unmet need.
Privosegtor
Privosegtor, a novel small molecule peptoid that penetrates the blood-brain and retinal barriers and was selected by high-throughput screening for its neuroprotective properties, has the potential to become the first neuroprotective therapy for ON and other neuro-ophthalmic and neurological diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential, as evidenced by improvements in visual function, low neurofilaments released in the blood and anatomical preservation of the retina after an acute episode of optic neuritis. Consistent results were observed
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in animal models of glaucoma, ON and MS, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON. Privosegtor has now entered registrational trials for ON and a registrational trial in NAION as part of our PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect in these orphan conditions, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.
Our planned first wave of development with Privosegtor is focused on acute optic neuropathy indications, ON and NAION, which are both rare diseases with high unmet medical needs. Currently there are no specific neuroprotective treatments which are approved by the FDA or EMA for ON and no medical or surgical treatment has been shown to improve the prognosis for NAION. In October 2025, we announced the initiation of the PIONEER program, which includes three pivotal trials to support registration plans for Privosegtor in ON and NAION. The first two trials, PIONEER-1 and PIONEER-2, will evaluate Privosegtor following the acute onset of optic neuritis in a broad population consisting of patients with multiple sclerosis (“MS”) and those without MS. The primary endpoint will be measured as low-contrast visual acuity (“LCVA”) at three months. Dosing and patient enrollment criteria will mirror those of the positive Phase 2 ACUITY trial. PIONEER-1 was initiated in the fourth quarter of 2025, with PIONEER-2 planned to follow in the first half of 2026. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION. This study shares the core design and operational elements with PIONEER-1 and PIONEER-2, and is expected to initiate in mid-2026. Running the three PIONEER registrational trials concurrently is expected to create operational synergies, improve cost efficiency and accelerate development timelines.
ON is a condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be greater than 30,000 cases annually and often represents the first sign of MS. ON mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1). It is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells cannot send signals properly and axons can be damaged irreversibly. To date there is no neuro-protective therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.
NAION is an acute optic nerve disorder that causes permanent visual impairment in more than 60% of affected patients. It is the most common cause of acute optic nerve injury in individuals over 50 years old and affects up to 10.2 per 100,000 people worldwide with a U.S. incidence estimated to be greater than 30,000 cases. In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies in the retina are permanently lost, leading to significant irreversible visual impairment or even blindness. There are no approved therapies for NAION and the unmet medical need is for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.
For the second wave of development, given that ON is often the first manifestation of MS and a common relapse type in MS, we plan to explore the broader potential of Privosegtor to treat MS relapses. To initiate this, we plan to submit a new IND for this indication with the neurology division of the FDA in 2026 by cross-referencing the current IND in ON.
MS is a prevalent disease affecting approximately 2.8 million people worldwide with approximately 850,000 cases in the U.S. alone. It is more prevalent in women and the average age at diagnosis is typically between 20 and 40 years old. It is an unpredictable disease of the central nervous system, which includes the brain, spinal cord and optic nerves. MS lesions disrupt the flow of information within the brain, and between the brain and body. It affects function in cognitive, mood, motor, sensory and visual areas. Symptoms of MS can include fatigue, memory difficulties, mood changes, mobility issues, numbness, pain, tingling and vision impairment. The two main types of MS are relapsing MS and progressive MS. Relapsing MS is the most common type representing approximately 85% of patients at initial diagnosis and is characterized by relapses driven by a person’s immune system attacking the central nervous system, leading to inflammation, demyelination and neurodegeneration. The prevalence of MS relapses in the U.S. alone is estimated to be around 170,000 cases per year. The symptoms of relapsing MS vary from person to person and depend on where inflammation and damage are occurring at any specific time. Current treatment like ON typically focuses on immunotherapies to reduce the number of relapses which can cause permanent disability, often referred to as “relapse-associated worsening.” At the time of an acute relapse, most neurologists recommend a short course of high-dose corticosteroids to reduce the inflammation and end the relapse faster. However, corticosteroids have no influence on the occurrence of new relapses or long-term disability. As there are no neuroprotective therapies approved for MS relapses, there remains an unmet medical need for treatments that can prevent central nervous system damage due to relapses and reduce the risk of future disability and disease progression.
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Our Executive Management Team
We are led by an experienced management team, composed of individuals who have extensive backgrounds in drug discovery and development, clinical trial design and operations, regulatory affairs, business development and commercialization, in addition to general management at both large pharmaceutical companies and emerging biopharmaceutical organizations. Collectively, our management team has a track record of advancing new drug candidates through regulatory approval and successful commercialization. The expertise of our management team is complemented by our board of directors, which includes many accomplished industry veterans with significant capabilities in guiding the success of emerging biopharmaceutical companies such as ours. Since our inception through December 31, 2025, we have raised approximately CHF 493.6 million from leading North American, European and Asian life science investors.
Our Strategy
We intend to become a leader in developing innovative therapeutics to address neuro-ophthalmic and ophthalmic diseases characterized by significant medical needs with large market opportunities. To accomplish this objective, we plan to focus on the successful completion of our key strategic initiatives. In ophthalmology, we are focused on advancing the clinical and regulatory plans of OCS-01 to bring a first-in-class topical eye drop therapy for the treatment in DME and developing Licaminlimab for precision medicine in DED. Furthermore, we are advancing the development of Privosegtor for ON and NAION and exploring broader indications in neuro-ophthalmology and neurology.
Based on the positive results achieved in the DIAMOND Stage 1 Phase 3 trial, we have progressed to the pivotal Phase 3 trials of OCS-01 in DME, DIAMOND-1 and DIAMOND-2, which are currently ongoing with anticipated readout in the second quarter of 2026. We believe the use of OCS-01 formulated as a non-invasive, self-administered eye drop, could, if approved, promote a shift in the current treatment paradigm to allow earlier treatment intervention and increase both the treated patient population and the prescribing physician base. In addition, OCS-01, if approved, could benefit patients who are diagnosed with DME and who have an inadequate response to anti-VEGF intravitreal injections.
Following a successful meeting with the FDA in the first quarter of 2025 and given the positive and consistent results achieved with Licaminlimab in three Phase 2 clinical trials for the treatment of DED and the observed enhanced response in patients with a specific TNFR1-genotype, we initiated the PREDICT-1 registrational Phase 2/3 trial with a genotype-based approach in the fourth quarter of 2025. We believe this precision medicine approach may allow the candidate to deliver superior outcomes in this patient group, if approved.
Based on the positive results achieved in the ACUITY trial announced in January 2025, we have initiated the PIONEER program, which includes three pivotal trials to support registration plans in ON and NAION. Running the three PIONEER registrational trials concurrently is expected to create synergies, improve cost efficiency and accelerate development timelines. The differentiated and novel mechanism of action of Privosegtor, coupled with its potential neuroprotective properties, suggest potential benefits across many of the more pervasive neurological pathologies of the eye such as glaucoma, but also for serious neurological conditions such as MS. We plan to submit an IND to the FDA in 2026 for MS by cross-referencing the existing IND in ON.
The differentiated and novel mechanism of action of Privosegtor, coupled with its potential neuroprotective properties, suggest potential benefits across more pervasive neurological pathologies of the eye such as glaucoma, but also for serious neurological conditions such as multiple sclerosis. We evaluated Privosegtor in a first-in-patient trial for ON, called the ACUITY trial, for which we announced positive topline results in January 2025. There is currently no specific neuroprotective therapy approved for treatment of ON. Privosegtor has been granted Breakthrough Therapy designation by the FDA and Orphan Drug designation by both the FDA and the European Commission. We believe that the demonstration of functional, anatomical, and biological neuroprotective benefits in ON provides compelling support for the exploration of Privosegtor in NAION, another acute optic neuropathy with high unmet needs, and also, for larger market opportunities in ophthalmology, neuro-ophthalmology and neurology indications including for the treatment of MS relapses.
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We have retained rights globally to all of our indications, including our lead product candidate OCS-01 eye drops for the potential treatment of DME; Licaminlimab for the potential treatment of DED with a precision medicine approach; and Privosegtor as a neuroprotective agent for ON, NAION and potentially other neuro-ophthalmology and neurology indications. Given the potential to treat patients worldwide, we may opportunistically enter into strategic collaborations around certain product candidates, diseases or geographic regions.
Our clinical development candidates
Utilizing our internal formulation discovery and drug development capabilities, together with extensive licensing, collaboration and acquisition activities, we have assembled a pipeline of attractive development candidates that include both late-stage clinical candidates as well as earlier stage preclinical initiatives. Our clinical portfolio is made up of (i) OCS-01, currently in two ongoing Phase 3 clinical trials in DME with topline results expected in the second quarter of 2026; (ii) Licaminlimab, for which we initiated the PREDICT-1 registrational Phase 2/3 trial with a genotype-based approach in the fourth quarter of 2025 to drive precision medicine in DED. Topline results from the PREDICT-1 trial are anticipated in the fourth quarter of 2026; and (iii) Privosegtor, a novel neuroprotective agent with potential broad applicability in multiple neurodegenerative diseases in ophthalmology, neuro-ophthalmology and neurology, which we are initially developing as a potential treatment for ON and NAION.
OCS-01
Key program highlights:
OCS-01 is a 1.5% suspension of the anti-inflammatory corticosteroid dexamethasone for use as a potential treatment for DME. In contrast to currently available therapies, which require the use of more invasive treatments such as an implant or intravitreal injection to deliver the medication to the retina, differentiating OCS-01 is our use of the proprietary OPTIREACH® technology, which enables the topical eye drop delivery of dexamethasone to the back of the eye for the treatment of diseases affecting the retina. Via this technology, OCS-01 has been observed in clinical trials to be capable of delivering therapeutic levels of drug to the retina via eye drop, a route of administration for DME treatment that may enable earlier treatment intervention and thereby significantly increase the proportion of patients being treated, as well as increase the prescribing physician base by providing a treatment option to general ophthalmologists. We are currently not aware of the existence of any other eye drop treatment for DME which is in a similar or more advanced stage of active clinical development; however, we cannot guarantee that OCS-01 will receive regulatory approval.
Dexamethasone is a widely studied and well characterized pharmaceutical commonly used to treat a range of inflammatory conditions and is currently included on the World Health Organization’s List of Essential Medicines. It may be administered orally, by injection, or topically. Specific to ocular disorders, dexamethasone intravitreal implants have been approved by the FDA to treat DME and macular edema caused by RVO.
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We are developing OCS-01 as a g cyclodextrin-based formulation of dexamethasone, using the OPTIREACH® delivery technology, in order to enhance its residence time at the anterior segment and its penetration into the posterior segment of the eye following topical application. The increased drug residence time produced by the delivery vehicle, combined with enhanced drug penetration allows for increases in drug concentration of more than 15-fold over conventional dexamethasone. We are currently not aware of the existence of any other topically administered formulation of dexamethasone or other active pharmaceutical ingredient in development intended to deliver sustained therapeutic levels of drug to diseased tissue at the back of the eye.
The OPTIREACH® technology enables the topical delivery of therapeutics to the back of the eye.
OCS-01 for DME
We are advancing OCS-01 as a treatment for DME, which is a complication of diabetes and is caused by the progressive growth of new blood vessels under the retina that leak fluid and lipids, leading to swelling of the macula, which can result in significant blurring of vision and contribute to the risk of blindness from DR. DME is strongly associated with uncontrolled blood sugar levels, high blood pressure and high cholesterol. An estimated 7% of diabetics worldwide are affected by the disease. It is a leading cause of blindness among the U.S. adult population. In the G7 countries (the United States, France, Germany, Italy, Spain, UK and Japan), the market for the treatment of DME is anticipated to reach approximately $5 billion in 2025.
The total U.S. prevalence of DME in 2024 was estimated at 3.0 million patients, with the diagnosed U.S. prevalence estimated at 1.8 million patients, including 1.0 million patients treated and 0.9 million patients diagnosed but untreated. These 0.9 million untreated patients are a key addressable market segment for OCS-01, especially for those with mild visual impairment. Including the market segment of patients with inadequate response to anti-VEGF therapy, we estimate that a total of 1.3 million DME patients in the United States are addressable by OCS-01.
Limitations of current treatments for DME
In the G7 countries, the DME disease onset may initially go unnoticed and as a result, in 2025, an estimated 41.6% of patients with DME may go undiagnosed. Furthermore, based on data from the American Academy of Ophthalmology’s (AAO) IRIS Registry, approximately 40% of newly diagnosed DME patients received treatment within the first year of diagnosis. This means over 60% of newly diagnosed patients were not treated in the first 12 months.
Pharmacotherapy involves the invasive administration of a monoclonal antibody therapeutic targeting the VEGF receptor to inhibit blood vessel growth. However, we estimate that approximately 40% of patients have an inadequate response to therapy after 12 weeks of anti-VEGF treatment, according to the results of a study published in the American Journal of Ophthalmology in 2016. Moreover, multiple intravitreal injections are required to maintain a therapeutic effect, which necessitates an increased treatment burden on patients, their caregivers and healthcare providers. Patients whose disease progresses while on anti-VEGF therapy may then receive a steroid implant, or laser photocoagulation of the retina.
The 2017 IRIS Registry analysis of 13,410 newly diagnosed, treatment-naïve patients found that observation (no treatment) within the first year was common. We believe this decision to observe and not intervene is often driven by the significant burden current treatment options (frequent intravitreal injections, intravitreal implants, or laser photocoagulation) place on the patient, as well as the expense and significant demands placed on healthcare resources. FDA approved therapeutics are not widely used for early disease intervention, despite some patients experiencing a deterioration in vision, if left untreated.
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OCS-01’s innovation and differentiation
OCS-01 is in development to be a topical treatment for DME, and we are currently not aware of the existence of any other eye drop treatment for DME which is in a similar or more advanced stage of active clinical development. In addition to this potential breakthrough advancement, we believe that an eye drop therapy would enable earlier disease intervention in DME if approved, potentially expanding both the patient population and prescribing physician base. We expect that OCS-01, if approved, could address patients who are diagnosed with DME, with mild visual impairment and who are currently observed and untreated, as well as patients who are diagnosed with DME and who have an inadequate response to anti-VEGF intravitreal injections. We estimate that both segments of patients combined, observed patients with mild visual impairment and inadequate responders to the current standard of care, totals 1.0 million patients in the United States alone.
OCS-01 has produced clinical trial results which support its continued development as a potential topical treatment for DME
In Stage 1 of our DIAMOND Phase 3 clinical trial which evaluated the use of OCS-01 as a treatment for DME, patients who received OCS-01 demonstrated a statistically significant improvement from baseline in key measurements of therapeutic efficacy. In this randomized, double masked trial of 148 DME patients with 2:1 randomization (OCS-01 vs. vehicle), 100 of the trial participants self-administered OCS-01 eye drops six times per day for a six-week induction phase then three times per day for a subsequent 6-week maintenance phase, with 48 participants administered vehicle only. As noted in the graphic presented below, OCS-01 demonstrated improvement in mean BCVA “Early Treatment Diabetic Retinopathy Study” chart (BCVA ETDRS) score from baseline to Week 6 versus (vs) vehicle (OCS-01: 7.2 letters vs vehicle: 3.1 letters, p=0.007) demonstrating strong visual gain in the treatment arm. The effect was sustained to Week 12 with statistical significance (OCS-01: 7.6 letters vs vehicle 3.7 letters, p= 0.016).
OCS-01 generated improvements in both CMT and BCVA measurements
Furthermore, there was a higher percentage of patients in the OCS-01 group who achieved ≥15-letter improvement in BCVA from baseline vs vehicle at Week 6 (OCS-01: 25.3% vs vehicle: 9.8%, p=0.015), which was sustained to Week 12 (OCS-01: 27.4% vs vehicle 7.5%, p=0.009).
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Improvements in both CMT and BCVA were greater among patients with lower baseline visual acuity.
A rapid reduction in retinal edema was observed in the OCS-01 treatment arm at week 2 of the study. The observed statistical significant treatment effect versus vehicle was preserved throughout the study.
Treatment emergent adverse events (“TEAEs”) were noted in 70 of the 100 trial participants who received OCS-01, with the most prevalent adverse event (“AE”) being an increase in IOP or ocular hypertension, which was observed in 14 of the 100 patients and 8 of the 100 patients in the active group, respectively. There was a small mean IOP increase, which was similar across induction and maintenance phase.
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These findings of increased IOP were consistent with our expectations given glucocorticoids’ well-known ocular safety profiles, including the profile of an approved dexamethasone ocular implant. The findings were also consistent with current literature. Overall, the IOP effects observed in our trial were consistent with what is generally expected given established ophthalmic use of dexamethasone. Other AEs observed during clinical trials included diabetic and macular edema, which was reported more frequently in vehicle treated patients.
Except for increased IOP, AEs of a similar nature and number were noted among trial participants who received vehicle. The number of subjects with any ocular or non-ocular AEs leading to trial discontinuation was higher in the vehicle arm compared to the active arm. While OCS-01 may contribute to an accelerated onset of cataracts, no evidence of cataract formation was observed in the treatment arm up to 12 weeks.
The Stage 1 DIAMOND Phase 3 clinical trial results followed outcomes achieved in the earlier Phase 2 study and two earlier small exploratory studies of DexNP (a previous formulation of OCS-01). In one of the studies, which was conducted in Japan in 2015, a 22-patient evaluation compared the use of a topically delivered g cyclodextrin-based formulation of dexamethasone to the posterior injection of 20 mg triamcinolone acetonide. Used at the time of the trial as an off-label treatment for DME, the g cyclodextrin-based formulation generated significant improvements in visual acuity and decreased macular thickness, comparable to the results achieved using triamcinolone acetonide. The results of this 2015 study confirmed similar findings achieved in another 19-person exploratory Japanese study conducted in 2011.
Phase 3 trial design for OCS-01
Our DIAMOND program includes two stages: Stage 1 has been completed, and in Stage 2, we are conducting two, 52-week pivotal Phase 3 trials, DIAMOND-1 and DIAMOND-2. These global Phase 3 trials enrolled over 400 subjects in each trial. The primary endpoint of these studies is the mean change from baseline in BCVA at 52 weeks. Key secondary endpoints include the mean change in macular thickness, as assessed by spectral domain optical coherence tomography and the percentage of participants that exhibit ETDRS improvement of 15 letters or more from baseline. Key inclusion criteria are similar to those used in Stage 1 of the program. The Phase 3 clinical trial protocol was reviewed by the FDA during an End-of-Phase 2 meeting.
OCS-01 has the potential to expand the number of treated patients and prescribing physicians
OCS-01 was designed to address two sizeable treatment gaps among the DME patient population in early intervention and in patients inadequately controlled with the current standard of care. Furthermore, the delivery of the drug to the back of the eye and non-invasive self-administration are unique differentiators to currently available treatments. Addressing the two existing treatment gaps may allow for increased early disease intervention potentially expanding both the patient population and prescribing physician base. If approved, OCS-01 may also be used as a non-invasive complement to currently approved therapeutic regimens, including anti-VEGF medications, potentially extending or enhancing the clinical benefit of those treatments particularly among those patients with more advanced diseases whose condition has not responded adequately to the current standard of care.
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Licaminlimab
Key Program Highlights:
We are developing Licaminlimab as a next-generation biologic treatment for DED. Licaminlimab is differentiated by its use of a single chain antibody fragment technology directed against the cytokine human TNFα to enable the topical delivery of an anti-TNFα construct at increased concentrations. The anti-inflammatory and anti-necrotic/anti-apoptotic properties of therapeutics inhibiting TNFα activity are well established with anti-TNF pharmaceuticals already approved as systemic treatments for ocular disease. While Licaminlimab could be developed for all comers with DED, we are advancing the development of Licaminlimab in conjunction with the development of a novel genetic biomarker intended to identify patients who are more likely to have a greater response to Licaminlimab therapy and believe this precision medicine approach may allow the candidate to deliver superior outcomes in these patients if approved.
Two Phase 2 clinical trials in patients with symptoms of DED were conducted (the first with the predecessor of Licaminlimab, and the second with Licaminlimab). Topical ocular administration of Licaminlimab demonstrated improvements in the global ocular discomfort score versus vehicle in patients with DED, as well as being well tolerated in both studies. In June 2024, we announced positive topline results from the Phase 2b RELIEF study evaluating Licaminlimab as a treatment for moderate-to-severe DED. In the RELIEF study, Licaminlimab was well tolerated similar to vehicle. Additionally, improvements in multiple sign efficacy endpoints were observed in the full population and with predictive and more pronounced effects in the TNFR1 genetic biomarker population as identified in the prior successful Phase 2 symptoms trial. We have consulted with the FDA during the first quarter of 2025 and initiated PREDICT-1, a registrational Phase 2/3 trial with a genotype-based approach to investigate Licaminlimab in DED in the fourth quarter of 2025. Topline results from this trial are anticipated in the fourth quarter of 2026.
TNFα performs important roles in the initiation and propagation of both normal and aberrant immune responses via mechanisms ranging from the stimulation of other cytokines to inflammatory cell recruitment to the alteration of vascular permeability. Inhibition of TNFα has demonstrated significant clinical benefit in the treatment of an array of diseases arising from dysfunctional immune system activity and anti TNFα therapeutics have become among the most widely prescribed biologics. Three anti-TNFα therapeutics (etanercept, sold under the brand name Enbrel®, infliximab, sold under the brand name Remicade®, and adalimumab, sold under the brand name Humira®), have each been studied for use in ocular disease. While the use of antagonists to TNFα have demonstrated favorable efficacy in the treatment of ocular inflammatory diseases, these drugs require intravenous infusion or subcutaneous injection and systemic anti-TNFα therapies are associated with a range of often serious adverse effects. Ocular diseases, such as DED, involve a local TNFα driven inflammatory process which may not justify general, systemic TNFα-suppressive therapy. The novel design of Licaminlimab embracing lower molecular weight single chain antibody fragment technology may enable it to be used in ocular disease as an eye drop for localized administration.
Licaminlimab for the treatment of DED
DED is a multifactorial disease of the tears and ocular surface characterized by ocular surface inflammation and increased osmolarity of the tear film that results in ocular discomfort, visual disturbance and tear film instability. The etiology of DED can involve several deficiencies of the tear film, including the aqueous layer, the lipid layer, mucin layer or a combination of the three layers. The disease often presents as a complication of other diseases, prominently autoimmune disorders such as rheumatoid arthritis, diabetes and Sjogren’s syndrome, which may contribute to its manifestation. As such, DED may afflict individuals with differing severity of burning sensation, a feeling of dryness, and other symptoms of ocular discomfort. In severe cases, vision may be significantly impaired. Although the pathogenesis of DED includes a variety of causes, common consequences are a breakdown of corneal tear film with dehydration of the exposed outer
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corneal surfaces, ocular surface inflammation and subsequent damage to exposed tissues. Increased concentration of pro-inflammatory cytokines, such as TNFα, in patient tears or conjunctival tissue has been demonstrated to correlate with disease severity.
In 2025, the U.S. DED patient population was approximately 39.8 million people and is expected to rise to 41.3 million patients by 2029. The market for prescription medications to treat DED is forecasted to increase to $7.3 billion in the G7 countries (the United States, France, Germany, Italy, Spain, UK and Japan) by 2029 from $5.4 billion in 2024. We estimate the segment of DED patients in the United States addressable by Licaminlimab to be approximately 10 million, consisting of moderate to severe DED with a potential focus on the specific TNFR1-genotype present in approximately 20% of the population.
Limitations of current therapies and potential for Licaminlimab in DED
The DED patient population is significantly underpenetrated with only an estimated 13% of diagnosed U.S. patients expected to receive prescription treatments. The vast majority of patients who do receive treatment are treated with anti-inflammatory drugs, yet among treated patients 87% are unsatisfied and feel that their chronic dry eye disease is not well managed. Approved topical treatments for DED include Restasis®, Cequa® and Vevye®, which are formulations of cyclosporine. These drugs act only to increase tear production and are not indicated to reduce DED symptoms. Further limiting cyclosporine’s therapeutic utility is a delayed onset of action necessitating a two- to three-month steroid bridge, and a stinging sensation on application in some patients. Topical steroids, including Eysuvis®, are also often used to treat DED but are contraindicated for long-term use because of their side effects including glaucoma and cataracts. Other treatments available for DED include Xiidra®, Tyrvaya®, Miebo®, and recently launched Tryptyr®.
Licaminlimab’s differentiation as a potential treatment for DED
Given the central role of ocular inflammation in sustaining the pathology of DED and the utility of anti-TNFα as a highly effective anti-inflammatory agent, we believe the localized application of Licaminlimab as an anti-TNFα therapeutic, if approved, may provide a differentiated DED treatment approach, which may effectively reduce ocular discomfort, avoid undesirable features of current therapies (such as stinging sensation, delayed onset of action, or steroid-related side effects), and provide benefit for many patients who do not receive lasting relief from current therapies. In addition, the potential for a precision medicine approach with Licaminlimab could address the unmet need to predict treatment response in the highly heterogeneous DED population.
We estimate the segment of DED patients in the United States addressable by Licaminlimab to be approximately 10 million patients with moderate or severe DED with a potential focus on the specific TNFR1-genotype present in approximately 20% of the population.
Licaminlimab has produced clinical trial results which support its continued development as a potential treatment for DED
In the first half of 2024, we conducted the Phase 2b RELIEF trial, which was a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of Licaminlimab in subjects with signs of DED (NCT05896670). The trial also evaluated the efficacy and safety of Licaminlimab in a subpopulation of subjects with a TNFR1-related genotype as prespecified in the protocol. One hundred and twenty-two (122) patients were randomized 1:1 to either Licaminlimab (n=62) or vehicle (n=60) across 4 sites for a 6-week treatment period and a 2-week follow up. A total of 23 patients carried a specific TNFR1-related genotype. Patients were evaluated for efficacy endpoints at baseline, Day 15 and Day 43. The prespecified investigational efficacy measures in this trial included multiple signs of DED that are accepted by the FDA as efficacy endpoints.
Novartis, from whom we have obtained certain exclusive, worldwide rights to develop and commercialize Licaminlimab through a December 19, 2018 licensing agreement (please see the section entitled “Material Licenses, Partnerships and Collaborations” below), conducted a randomized, multi-center, double-masked, vehicle controlled Phase 2 clinical PoC trial designed to assess the safety and tolerability of Licaminlimab and its efficacy in reducing DED symptoms. In the trial, patients were randomized on a 1:1 ratio into two cohorts. For a six-week period, the first trial cohort received a 60 mg/ml ophthalmic solution of Licaminlimab, while the second received vehicle. Participants in both cohorts self-administered one drop to each eye three times per day. The primary efficacy endpoint of the trial was improvement in the global ocular discomfort score as compared to vehicle. The global ocular discomfort score is a composite of discomfort frequency and severity as assessed by a visual analog scale using an electronic patient reported outcome. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort Score as compared to baseline. A negative change from baseline indicates improvement. The secondary efficacy endpoint was an assessment of the number of patients that achieved more than 20 points improvement in the global
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ocular discomfort score. The data generated in this trial, consisting of 67 participants in the active group and 64 in the control group, are presented in the charts below.
Licaminlimab generated statistically significant improvement in ocular discomfort as compared to vehicle.
The trial met both primary and secondary endpoints. As is noted in the left chart above, administration of Licaminlimab resulted in a statistically significant 7.9 mean point reduction in the global ocular discomfort score from baseline to treatment day 29 as compared to a 3.6 point mean reduction among patients that received vehicle only. In addition, as is noted in the right chart above, Licaminlimab generated an improvement in the global ocular discomfort score of greater than 20 points in 12 of the 67 patients, or 18% of total trial participants. A similar level of response was achieved in only 5%, or three of the 64, patients included in the vehicle control group. The results of exploratory endpoints, which included physician graded conjunctival hyperemia, corneal staining, Meibomian gland assessment and tear film osmolarity, were similar across treatment groups. Licaminlimab demonstrated a statistically significant improvement in the global ocular discomfort score compared to vehicle in patients with severe DED. It was well tolerated, with no increase in IOP and minimal systemic drug exposure.
Proprietary genetic biomarker may enable a precision medicine approach to DED
We conducted an exploratory pharmacogenetic analysis focused on the genes relevant to the TNF pathway and Sjogren’s syndrome among those 12 out of 86 patients who had the CC genotype gene variance or SNP. Among the gene variants analyzed, a correlation between one variant (rs1800693 CC genotype, “CC genotype”) in the TNFR1 gene, and a greater response (p<0.0001) to Licaminlimab was observed at Day 29. The below figure shows individual patient profiles by study days for change from baseline global ocular discomfort score for participants with the CC genotype.
Patients with this variant displayed a significant reduction in inflammatory factors, including interleukin 1 beta (IL1B), interleukin 8 (IL8) and TNFα.
Phase 2b RELIEF trial design and topline results
In light of the results generated by Licaminlimab in its Phase 2 PoC trials, we advanced Licaminlimab into a 122 subject Phase 2b RELIEF clinical trial to evaluate the safety and efficacy of Licaminlimab in treating the signs of DED. This trial was randomized, multi-center, double masked and vehicle-controlled. Following initial screening, trial participants are
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randomized on a 1:1 basis into either the treatment cohort or the vehicle cohort and received Licaminlimab 60mg/mL or vehicle three times daily for six weeks, followed by a two week follow up period. Participants were evaluated for efficacy endpoints at baseline, Day 15 and Day 43. The prespecified investigational efficacy measures in this trial included multiple signs of DED that are accepted by the FDA as efficacy endpoints, such as total corneal fluorescein staining, the percentage of patients with a 10 mm or greater increase in Schirmer’s test, compared to vehicle. Biomarker analyses (from impression cytology samples) were additional endpoints of the trial.
One hundred and twenty-two (122) patients were randomized 1:1 to either Licaminlimab (n=62) or vehicle (n=60) across 4 sites for a 6-week treatment period and a 2-week follow up. A total of 23 patients carried a specific TNFR1-related genotype.
Phase 2b RELIEF trial showed positive effects on multiple signs of DED:
Licaminlimab was well tolerated. The incidence of ocular TEAEs in the study eye was 11.5% in the Licaminlimab group and 10.2% in the vehicle group. TEAEs in the fellow eye were similar to the study eye. All ocular TEAEs were mild and transient, and there were no serious ocular adverse events observed with Licaminlimab in the study. Drop comfort was also evaluated and was similar to artificial tears.
Privosegtor
Key Program Highlights:
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We are advancing Privosegtor, a novel peptoid small molecule candidate with the potential to become, if approved, a first-in-class neuroprotective therapy for ON, NAION and other neuro-ophthalmic and neurological diseases. The planned first wave of development focuses on acute optic neuropathies with the assessment of Privosegtor as a potential therapy to treat ON and NAION in the PIONEER program with three registrational trials. Privosegtor has been granted Breakthrough Therapy designation by the FDA and Orphan Drug designation by both the FDA and the European Medicinal Agency (“EMA”) for this indication. Privosegtor has been studied in preclinical studies suggesting neuroprotective and remyelinating activity, as well as in a UK Phase 1 clinical trial (with 48 healthy volunteers) in which Privosegtor was well tolerated and showed pharmacokinetics (“PK”) with good correlation to its pre-clinical animal studies. We completed a Phase 2 trial with Privosegtor in ON in France, for which we announced positive topline results in January 2025. Based on these results, we intend to evaluate the potential of Privosegtor to treat other more pervasive neurological pathologies of the eye and other serious neurodegenerative disorders like MS. On January 29, 2022, we obtained an exclusive worldwide license to develop Privosegtor through a licensing agreement with Accure Therapeutics SL (please see the section entitled “Material Licenses, Partnerships and Collaborations” below).
Privosegtor was selected by high-throughput screening (HTS) for neuroprotective properties, confirmed in vivo in glaucoma, multiple sclerosis, and optic neuritis models. The data from in vitro studies suggest that it activates the serum–glucocorticoid kinase and triggers multiple beneficial effects on apoptosis, oxidation, and inflammation.
Privosegtor for the treatment of ON
ON is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide and often represents the first sign of MS. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1).
ON is commonly associated with MS and shares similar physiopathology. ON is the presenting symptom of MS in 15.0-20.0% of patients and will impact over 50.0-65.0% of patients with MS at some time during their lifetime. However, the causes of ON are not always clear, as it can also arise in patients without MS.
The acute inflammation of the optic nerve causes the loss of myelin and oligodendrocytes, optic nerve conduction block and loss of vision. At the onset of ON, patients often suffer from ocular pain increasing with eye movement, associated with a variety of visual impairments. Deterioration of visual acuity, color vision or flashes of light are common. The loss of vision ranges considerably between patients from mild blurring to loss of perception of light. The condition tends to worsen over the first several days after the appearance of symptoms before starting to improve over the first two weeks. The recovery continues for as long as a year after onset. Even if high contrast visual acuity returns to near normal, patients often report that their vision has not completely recovered. There remains a persistent impairment of low contrast letter acuity and clinically meaningful reduction in vision-related quality of life.
When the inflammation recedes, remyelination often occurs but it is incomplete, the result of persistent demyelination and neuronal death. Without the myelin sheath which normally protects the axon, neurons located in demyelinated segments become fragile and prone to death. Visual symptoms such as reduced visual acuity are accompanied by measurable structural changes in the optic nerve and retina. Following the acute inflammatory phase, progressive thinning of the ganglion cell inner plexiform layer (GCIPL) occurs early, often within weeks to a few months, reflecting retrograde neuroaxonal degeneration. The magnitude of GCIPL loss correlates with persistent visual deficits, with greater structural loss associated with poor visual function.
No specific neuroprotective therapeutic is currently approved that preserves vision and ganglion/retinal nerve integrity after an acute episode of optic neuritis. Medication intended to treat the inflammation and related symptoms can be administered just after ON onset and patients often receive high doses of corticosteroids for a few days. While corticosteroids are used to shorten the attack and accelerate recovery of acute visual symptoms, there remains an unmet medical need for therapies that either preserve vision or provide neuroprotection after an acute episode of optic neuritis. We believe a neuroprotective therapeutic, such as Privosegtor, if approved, could provide functional vision improvement through neuroprotective anatomical and biological benefits, including preservation of retinal ganglion cells and prevention of neuronal and axonal death.
Privosegtor consistently demonstrated compelling neuroprotective properties in multiple pre-clinical trials and was well tolerated in a trial involving healthy volunteers
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Privosegtor has been studied in several preclinical studies with consistent results suggesting neuroprotective activity. In a high-pressure glaucoma model, Privosegtor was associated with a reduction of RGC damage. In an ON rat model, it showed prevention of optic nerve axonal loss and reduction of optic nerve demyelination. Finally, in a mice experimental autoimmune encephalomyelitis model (autoimmune model of ON and MS), it was associated with improvement of function (disability).
In a Phase 1 clinical trial with 48 healthy volunteers, Privosegtor was well tolerated and showed pharmacokinetics with good correlation to its pre-clinical animal studies.
We investigated Privosegtor as a treatment for ON in a First-in-Patient clinical trial
The results of prior clinical and preclinical trials of Privosegtor showing neuroprotective effects, together with the safety and PK profile observed in this first-in-human clinical trial enabled us to advance the compound into a Phase 2 clinical trial. The ACUITY trial, a randomized, double-masked, placebo controlled, multiple center trial, was a first-in-patient trial enrolling patients diagnosed with ON within twelve days of acute disease episode onset. The study randomized 36 patients with recent onset (visual loss symptoms) of unilateral AON with a demyelinating origin, of which 33 patients received treatment and were included in the pre-specified modified intent-to-treat (mITT) analysis. The objective of this study was to assess the safety and tolerability of Privosegtor along with initial signs of efficacy. In addition to the trial’s primary safety endpoint, key secondary endpoints evaluated the effect of Privosegtor on retinal layer thickness and other visual parameters in the affected eye. The study was conducted in France under French regulatory guidance and positive top line results were announced in January 2025. The ACUITY trial showed that Privosegtor achieved the primary safety endpoint in addition to efficacy with improvement in visual function in patients suffering from AON combined with positive neuroprotective surrogate biomarkers such as preservation of the GCIPL layer and reduction of neurofilament release in the blood.
Primary Endpoint: To evaluate cardiac safety, the percentage of patients with a shift from normal (baseline) to abnormal in electrocardiogram (“ECG”) parameters after study drug administration until Visit 4 (Day 15) was measured. The results showed no difference in the percentage of patients with abnormal ECG parameters between the two treatment arms. Two patients in the Privosegtor arms (2 and 3 mg/kg/day) and one patient in the placebo arm had a shift from normal to abnormal in any ECG measures between baseline and Visit 4 (Day 15), both equivalent to 12.5%. Events observed in the Privosegtor arms were mild and transient and qualified as not clinically significant by central review reading center.
Secondary Efficacy Endpoints Assessed Changes in Retinal Structure: Optical Coherence Tomography imaging was used to objectively measure the thickness of two different retinal segments in the affected eye to evaluate the potential neuroprotective effects of Privosegtor compared to placebo: 1) Ganglion Cell-Inner Plexiform Layer (GCIPL) and 2) Retinal Nerve Fiber Layer (RNFL).
Results showed a 43% improvement in GCIPL thickness mean change from baseline in favor of Privosegtor (3mg/kg/day) + steroid compared to placebo + steroid at month 3 which was maintained through month 6 with at 3 and 6 months, respectively.
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Additionally, a 28% improvement in RNFL thickness mean change from baseline in favor of Privosegtor (3mg/kg/day) + steroid compared to placebo + steroid at month 3 reaching 30% improvement at month 6 was observed.
Secondary Efficacy Endpoint Assessed Changes in Visual Function: Changes in 2.5% ETDRS LCVA were measured to assess visual function improvement. Results showed a favorable difference in LCVA mean change from baseline of approximately 18 letters at month 3 and approximately 15 letters at month 6 with Privosegtor (3 mg/kg/day) + steroid compared to placebo + steroid, with nominal p-values of 0.004 and 0.012 at 3 and 6 months, respectively.
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These results were also corroborated by a biological sign of neuronal and axonal death. Neurofilament is a biomarker of axonal and neuronal death which has been used in the past for the regulatory approval of a drug for amyotrophic lateral sclerosis (ALS), a terminal neurodegenerative disease. In the ACUITY trial, Privosegtor (3 mg/kg/day) + steroid was associated with significantly less neurofilaments in the bloodstream when compared to placebo + steroid.
Evaluation of TEAEs showed no drug-related SAEs and no AEs leading to drug withdrawal or study discontinuation. The most frequently reported drug related AEs > 10% in the Privosegtor (2 or 3 mg/kg/day) + steroid treatment group were headache: 2 patients (10.5%), and acne: 2 patients (10.5%).
We believe that positive outcomes in this trial could support Privosegtor’s development as a potential treatment in multiple other ophthalmic, neuro-ophthalmic and neurological conditions associated with neurodegeneration. The novel mechanism of action of Privosegtor may enable it to demonstrate benefit in treating additional ocular conditions and may additionally allow its development in non-ocular neurological disorders involving neuronal inflammation such as MS.
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Material Licenses, Partnerships and Collaborations
License Agreement with Accure for Privosegtor
Pursuant to a license agreement, dated as of January 29, 2022, by and between us and Accure (the “Accure Agreement”), we obtained an exclusive, worldwide, sublicensable (subject to certain conditions) and transferable (subject to certain conditions) license under certain patents, know-how and inventory of Accure for any and all uses and purposes, including to perform research, development, manufacturing and commercialization activities in any manner and for any purpose. The licensed patents are co-owned by Accure with third parties who have reserved the right to use the licensed patents for education and research purposes pursuant to an inter-institutional agreement.
As of December 31, 2025, we have paid the full contractual non-refundable upfront fee of CHF 3.0 million and reimbursed costs in the amount of CHF 0.5 million. During the fourth quarter of 2024, we completed the Phase 2 ACUITY trial of Privosegtor in ON and received clearance from the FDA for our IND application. These events triggered two milestone payments to Accure totaling CHF 1.1 million ($1.2 million) which were paid in January 2025. The next clinical and regulatory milestone under the Accure Agreement will trigger a payment of CHF 2.1 million ($2.6 million) that the Company expects to pay in 2026. As of December 31, 2025, we were obligated to pay Accure (a) up to CHF 87.9 million ($110.9 million at the December 31, 2025 exchange rate) in the aggregate upon the achievement of certain development, regulatory and sales milestones; (b) tiered royalties ranging from a mid-single digit to a low mid-teen percentage on net sales of licensed products; and (c) a percentage in the high teens on sublicensing revenues received any time after 36 months from the agreement effective date, and a higher percentage on sublicensing revenues received prior to such date, in all cases subject, in the case of this clause (c), to reduction for any amounts that were previously paid or are concurrently or later paid by us to Accure pursuant to our milestone payment obligations. Our royalty payment obligations are subject to certain reductions and expire on a licensed product-by-licensed product and country-by-country basis upon the later of (i) the expiration of the last valid claim of any licensed patent covering such licensed product in such country; (ii) the expiration of such licensed product’s Orphan Drug status, if any, in such country; or (iii) ten (10) years following the date of first commercial sale of such licensed product in such country (the “Payment Period”). Under the Accure Agreement, we are obligated to use commercially reasonable efforts to develop and seek regulatory approval for a licensed product in major countries of the territory as defined in the Accure Agreement.
The Accure Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the applicable Payment Period with respect to such licensed product in such country. We may terminate the Accure Agreement in whole or in part at any time upon advance written notice (a) for documented reasonable scientific, regulatory, commercial reasons related to the licensed product without incurring any penalty or liability to Accure and (b) for no reason. Each party may terminate the Accure Agreement with immediate effect upon written notice to the other party (i) in the event such other party commits a material breach of its obligations under the Accure Agreement and fails to cure that breach within a specified period of time or (ii) with certain exceptions, upon such other party’s bankruptcy. Accure may terminate the Accure Agreement with immediate effect upon written notice to us if we file any action to invalidate any of the licensed patents or fail to maintain the licensed patents in major countries of the territory as defined in the Accure Agreement, or, subject to certain exceptions, if we fail to meet certain development obligations and are unable to agree upon modifications to the development plan with Accure.
License Agreement with Novartis for Licaminlimab
Pursuant to a license agreement, dated as of December 19, 2018, as amended, by and between us and Novartis (the “Novartis Agreement”), we obtained an exclusive, royalty-bearing, sublicensable (subject to certain conditions), assignable (subject to certain conditions), worldwide license under certain patents, know-how and manufacturing platform technology to develop, manufacture and commercialize pharmaceutical, therapeutic or diagnostic products containing a specified single chain antibody fragment formulation as an active ingredient in the licensed field as defined in the Novartis Agreement. The license granted to us by Novartis includes sublicenses of rights granted to Novartis by certain third parties, and our license to such rights is expressly subject to the applicable terms and conditions of the agreements between Novartis and such third parties.
We are deemed the owner of any inventions that are (a) created solely by or on behalf of us pursuant to the Novartis Agreement and (b) severable from the licensed products, and grant Novartis a first right to negotiate a worldwide, royalty-bearing license under any patents directed at such inventions for purposes outside of the licensed field. We also grant Novartis a worldwide, non-exclusive, perpetual, irrevocable, royalty-free, fully paid-up license back under any patents owned by us that (i) cover inventions arising from the Novartis Agreement, the practice of which would infringe the patents licensed to us by Novartis, or (ii) otherwise incorporate Novartis’ proprietary information, in each case, for certain uses outside of the licensed field.
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We originally entered into the Novartis Agreement with Alcon Research, Ltd. (“Alcon”), which subsequently assigned its rights and obligations under the Novartis Agreement to Novartis in connection with Alcon’s spin-off from Novartis. We made an upfront payment to Alcon of CHF 4.7 million ($4.7 million at the exchange rate at the time of payment) in cash and issued 401,709 ordinary shares (recast using the Exchange Ratio to reflect the impact of the BCA) for the residual between the fair value and the upfront payment. This was accounted for as a share-based payment transaction under IFRS 2. As of December 31, 2025, we were obligated to pay Novartis additional up to CHF 76.9 million ($97.0 million at the December 31, 2025 exchange rate) in the aggregate upon the achievement of certain development, regulatory, sales and other milestones and tiered royalties ranging from a mid-single digit to a mid-teen percentage on net sales. In consideration for the exclusive sublicense from Novartis under certain third-party intellectual property rights, we are obligated to pay a low-single digit royalty on our net sales of the licensed product, however, such payments will be deducted from royalties payable to Novartis. Our royalty payment obligations are subject to certain reductions and expire with respect to any licensed product on a country-by-country basis upon the later of (a) the expiration of the last to expire valid claim of any licensed patent covering any such licensed product in such country; (b) the expiration of the period of data exclusivity in any country worldwide; or (c) twelve (12) years after first commercial sale of such licensed product in such country (“Royalty Term”).
Under the Novartis Agreement, we are obligated to use diligent efforts to develop, manufacture or have manufactured, and commercialize the licensed products in the licensed field worldwide. The Novartis Agreement will expire upon the last-to-expire Royalty Term. We may terminate the Novartis Agreement without cause at any time upon advance written notice to Novartis. Upon written notice to Novartis, we may terminate the Novartis Agreement for cause due to the following events: (a) an insolvency event occurs; (b) Novartis materially breaches its obligations under the Novartis Agreement and fails to cure such breach within a specified period of time; or (c) upon advance written notice for material scientific, technical or medical reasons or in case of a material adverse change that renders further continuation of the Novartis Agreement by us commercially unreasonable or otherwise not viable. Upon written notice to us, Novartis may terminate the Novartis Agreement for cause due to the following events: (i) we fail to pay any undisputed amount due under the Novartis Agreement and we fail to remedy such failure within a specified period of time; (ii) an insolvency event occurs; (iii) we materially breach our obligations under the Novartis Agreement and fail to cure such breach within a specified period of time; or (iv) following negative clinical trial results, we terminate development of the licensed product and do not pursue any further indications in the licensed field.
Manufacturing Strategy
We oversee and manage third-party global CMOs, to support the development and manufacture of product candidates for our clinical trials, and, if any product candidates receive marketing approval, we expect to rely on such global manufacturers to meet commercial demand. We expect this strategy will enable us to maintain a more efficient operating and cost infrastructure, avoiding dependence on our own manufacturing facility and equipment, while simultaneously enabling us to focus our expertise on the clinical development and future commercialization of our products, if approved. Currently, we rely on and have agreements with third-party contract manufacturers for OCS-01, Licaminlimab and Privosegtor, and we expect to enter into commercial supply agreements with such manufacturers prior to any potential approval. We continue to develop and improve the manufacturing processes for Privosegtor and Licaminlimab and to address the requirements in these highly regulated markets. Improvement of manufacturing processes may involve transferring the development and manufacturing to another CMO, taking into account technical, quality and economic aspects.
Each of OCS-01, Licaminlimab and Privosegtor is manufactured via conventional pharmaceutical processing procedures, employing commercially available excipients and packaging materials. The procedures and equipment employed for manufacture and analysis are consistent with standard pharmaceutical production, and are transferable to a range of manufacturing facilities, if needed.
Competition
We face substantial competition from multiple sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions and governmental agencies and public and private research institutions. Our competitors compete with us on the level of the technologies employed, or on the level of development of product candidates. In addition, many small biotechnology companies have formed collaborations with large, established companies to (i) obtain support for their research, development and commercialization of products or (ii) combine several treatment approaches to develop longer lasting or more efficacious treatments that may potentially directly compete with our current or future product candidates. We anticipate that we will continue to face increasing competition as new therapies and combinations thereof, technologies, and data emerge within the treatment of ocular conditions.
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In addition to the current standard of care treatments for patients with ocular diseases and the entry of biosimilars and generics, numerous commercial and academic preclinical studies and clinical trials are being undertaken by a large number of parties to assess novel technologies and product candidates.
Several large pharmaceutical and biopharmaceutical companies that have commercialized, or are developing treatments for ocular diseases, compete with us. Companies that have commercialized or are developing product candidates to treat DME include Abbvie, ANI Pharmaceuticals, Bayer, Novartis, Regeneron and Roche, among others. Companies that have commercialized or are developing product candidates to treat DED include Abbvie, Alcon, Bausch + Lomb, Viatris, Harrow, and Sun Pharmaceuticals, among others. Companies that are commercializing or developing products to treat neuro-ophthalmic conditions include Amgen, Dompé, Argenx, and Veridian, among others.
Many of our competitors, either alone or in combination with their respective strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, regulatory approval process and marketing than we do. Mergers and acquisition activity in the pharmaceutical, biopharmaceutical and biotechnology sector is likely to result in greater resource concentration among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through sizeable collaborative arrangements with established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, patient registration for clinical trials and acquiring technologies complementary to, or necessary for, our programs.
Our commercial opportunities could be reduced or eliminated if one or more of our competitors develop and commercialize products that are safer, more effective, better tolerated, or of greater convenience or economic benefit than our proposed product offerings. Our competitors also may be in a position to obtain FDA or other regulatory approval for their products more rapidly, resulting in a stronger or dominant market position before we are able to enter the market. The key competitive factors affecting the success of all of our programs are likely to be product safety, efficacy, convenience and treatment cost.
Intellectual Property
Intellectual property is of vital importance in our field and in biotechnology generally. We seek to protect and enhance proprietary technology, inventions, and improvements that are commercially important to the development of our business by obtaining, maintaining, enforcing and defending intellectual property rights, including patent rights, whether owned or licensed from third parties. We will also seek to rely on regulatory protection afforded through inclusion in expedited development and review, data exclusivity, market exclusivity and patent term extensions where available.
We have sought patent protection in the United States and internationally related to our novel drug targets, composition of matter, formulations and other inventions and improvements that are central to our R&D efforts. For our product candidates, our strategy is to pursue patent protection covering compositions of matter, formulations and methods of use. In addition, we seek to identify additional means of obtaining patent protection, including specific therapeutic indications and dosing regimen-related claims, which may enhance commercial success. We also rely on trade secrets that may be important to the development of our business. Trade secrets are difficult to protect and provide us with only limited protection.
As of December 31, 2025, we own and exclusively in-licensed a patent portfolio that included 23 issued U.S. patents, 6 issued European patents validated in multiple jurisdictions, and 63 issued patents in other foreign jurisdictions, as well as 12 pending non-provisional U.S. patent applications, and 90 foreign pending patent applications, including 12 pending European patent applications, and 3 pending Patent Cooperation Treaty (“PCT”) applications related to our different product candidates, namely, OCS-01, Licaminlimab, Privosegtor, OCS-03 and OCS-04.
OCS-01
Regarding our OCS-01 product candidate, as of December 31, 2025, we own a patent family that consisted of three issued U.S. patents and one granted European patent validated in 12 jurisdictions (Belgium, France, Germany, Great Britain, Iceland, Ireland, Italy, the Netherlands, Poland, Spain, Switzerland, Turkey) with claims covering the composition including dexamethasone. These patents will expire in 2026, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
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As of December 31, 2025, we also own a patent family consisting of 1 issued U.S. patent, 1 U.S. non-provisional patent application, one issued European patent validated in 41 jurisdictions (Albania, Austria, Bosnia, Belgium, Bulgaria, Swiss, Cyprus, Czech republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Hungary, Croatia, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldavia, Montenegro, Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, San Marino and Turkey), and one pending divisional application in Europe, 29 issued patents in other foreign jurisdictions issued patents (Australia, Brazil, Chile, China, Colombia, Eurasia (Armenia, Azerbaijan, Belarus, Kyrgyzstan, Kazakhstan, Russia – two patents, Tajikistan, Turkmenistan), Hong Kong, India, Israel, Japan (two patents), Mexico, Philippines, Singapore, South Africa (two patents), South Korea (two patents), Taiwan (two patents), Ukraine), pending applications in Argentina, Canada, Egypt and pending divisional applications in Argentina, China, Hong Kong, Israel, Singapore. This patent family is directed to improved compositions (and process of preparation thereof) of OCS-01 comprising low levels of impurities. Patents, if issued from patent applications in this family, will expire in 2037, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also own a patent family that consisted of 10 issued U.S. patents and 1 U.S. non-provisional patent application, one European issued patent validated in many jurisdictions (Albania, Austria, Belgium, Bulgaria, Swiss, Cyprus, Czech republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Hungary, Croatia, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, San Marino and Turkey), one pending divisional application in Europe, one South African issued patent, one Eurasian issued patent, one Japan issued patent, one Singapore issued patent, one Australian issued patent and 20 additional foreign patent applications in other jurisdictions, including one divisional European patent application, directed to specific formulations of OCS-01 and methods for stabilizing the composition for use as an eye drop. Patents, if issued from patent applications in this family, will expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also own one non-provisional U.S. pending application and two PCT pending applications as well as pending applications in Taiwan, with claims covering a specific treatment regimen for treating DME using OCS-01. In order for any future patent applications to claim the benefit of such PCT application, they must be filed not later than 30 or 31 months (depending on the jurisdiction) after the earliest priority date of such PCT application. Patents, if issued from such patent applications, will expire in 2043 or 2044, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
Licaminlimab
Regarding our Licaminlimab product candidate, as of December 31, 2025, we exclusively licensed from Novartis under the Novartis Agreement, in the licensed field as defined in the Novartis Agreement, one patent family that consisted of three issued U.S. patents and two granted European patents validated in 36 jurisdictions (Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey) and six jurisdictions (France, Germany, Great Britain, Italy, Spain, Switzerland), respectively, 22 issued patents in other foreign jurisdictions (Argentina, Australia, Brazil, Canada, Chile (two patents), China (two patents), India, Hong Kong (two patents), GCC, Japan (two patents), Republic of Korea, Mexico (two patents), Philippines, Russia, South Africa, Taiwan, Ukraine) and two patent applications pending in other foreign jurisdictions, with claims covering composition of matter of Licaminlimab or methods of use. Patents (including any patents that issue from such patent applications) will expire in 2031, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
In addition, as of December 31, 2025, we exclusively licensed from Novartis under the Novartis Agreement, in the licensed field as defined in the Novartis Agreement, one patent family directed on a biomarker for patient selection, that consists of one issued U.S. patent and one issued Japanese patent, one pending European and one U.S. patent applications and other patent applications pending in Canada and Japan. Patents (including any patents that issue from such patent applications) will expire in 2037, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
In addition, as of December 31, 2025, we exclusively licensed from Novartis under the Novartis Agreement, in the licensed field as defined in the Novartis Agreement, six additional patent families covering composition of matter of Licaminlimab or methods of use, which (including any patents that issue from patent applications in these families) will expire between
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2023 and 2031, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. Under the terms of the Novartis Agreement, Novartis is responsible for the prosecution and maintenance of these six patent families.
Privosegtor
Regarding our Privosegtor product candidate, as of December 31, 2025, we exclusively licensed from Accure under the Accure Agreement a patent family that consisted of three issued U.S. patents and one granted European patent validated in 24 jurisdictions (Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, Turkey), as well as 10 issued patents (Australia, Brazil, Canada, China, India, Israel, Japan, Republic of Korea, Mexico, Russia) in other foreign jurisdictions, with claims covering composition of matter of Privosegtor. These patents (including any patents that issue from such patent applications) will expire in 2031, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also exclusively licensed from Accure under the Accure Agreement a patent family that consisted of one pending non-provisional U.S. patent application, two issued patents in Australia and Japan and 7 pending foreign patent applications, including one pending European patent application (pending applications in Australia, Canada, China, Japan and Hong Kong), directed to the method of use of the composition of Privosegtor in combination with active compounds. Patents, if issued from such patent applications, will expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also exclusively licensed from Accure under the Accure Agreement a patent family consisting of two pending non-provisional U.S. patent applications, one issued patent in China and six pending foreign patent applications, including one pending European patent application (and pending applications in Australia, Canada, China, Japan), with claims directed to specific dosage regimen for administering the active pharmaceutical ingredient of Privosegtor. Patents, if issued from such patent applications, will expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also own a patent family consisting of pending applications in Argentina, Taiwan, Australia, Brazil, Canada, Chile, China, Colombia, Eurasia, Europe, Egypt, Hong Kong, Israel, India, Japan, South Korea, Mexico, New Zealand, Philippines, Singapore, Ukraine, United States and South Africa with claims covering a manufacturing process of Privosegtor and Privosegtor intermediate synthesis compounds. Patents, if issued from such patent applications, will expire in 2043, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also own a PCT pending application as well as pending applications in Europe, Argentina and Taiwan, with claims covering an alternative manufacturing process of Privosegtor. In order for any future patent applications to claim the benefit of such PCT application, they must be filed not later than 30 or 31 months (depending on the jurisdiction) after the earliest priority date of such PCT application. Patents, if issued from such patent applications, will expire in 2045, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of December 31, 2025, we also own one provisional U.S. application and two European non-published pending applications related to OCS-05.
OCS-03
As of December 31, 2025, we own a patent family that consists of one pending U.S. non provisional application and one pending European application, with claims covering composition of matter of OCS-03 and its use. Patents (including any patents that issue from patent application) will expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
OCS-04
As of December 31, 2025, we own one patent family consisting of a U.S. non-provisional patent application and a European patent application, with claims covering composition of matter of OCS-04 and manufacturing processes. In order for any future patent applications to claim the benefit of such PCT application, they must be filed not later than 30 or 31 months
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(depending on the jurisdiction) after the earliest priority date of such PCT application. Patents, if issued from the patent applications claiming the benefit of such priority application, if issued, will expire in 2043, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
Our commercial success will depend in part on obtaining, maintaining, protecting and enforcing patent protection and trade secret protection of our current and future product candidates and the methods used to develop and manufacture them, as well as successfully defending any such patents against third-party challenges, enforcing such patents against third-party infringers, and operating without infringing on, misappropriating or otherwise violating the intellectual property or proprietary rights of others. Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates will depend on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. We cannot be sure that patents will be issued with respect to any of our owned or in-licensed pending patent applications or with respect to any patent applications filed by us or our licensors in the future, nor can we be sure that any patents that may be granted to us or our licensors in the future will be commercially useful in protecting our product candidates, discovery programs and processes. For this and more comprehensive risks related to our intellectual property, please see the section entitled “Risk Factors—Risks Related to Our Intellectual Property,” included in Item 3.D. of the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 4, 2026.
The terms of individual patents depend upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, including the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO, in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent. In the United States, the term of a patent that covers an FDA-approved drug may also be eligible for extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the subject drug candidate is under regulatory review. U.S. patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar provisions to extend the term of a patent that covers an approved drug are available in Europe and other foreign jurisdictions. In the future, if and when our products receive FDA approval, we expect to apply for patent term extensions on patents covering those products. We plan to seek patent term extensions to any issued patents we may obtain in any jurisdiction where such patent term extensions are available, however there is no guarantee that the applicable authorities, including the FDA in the United States, will agree with our assessment that such extensions should be granted, and if granted, the length of such extensions. For more information regarding the risks related to our intellectual property, see section entitled “Risk Factors—Risks Related to Our Intellectual Property.”
We file U.S. non-provisional applications and PCT applications that claim the benefit of the priority date of earlier filed priority applications, when applicable. The PCT system allows a single application to be filed within 12 months of the original priority date of the patent application, and to designate all of the PCT member states in which national patent applications can later be pursued based on the international patent application filed under the PCT. The PCT searching authority performs a patentability search and issues a non-binding patentability opinion which can be used to evaluate the chances of success for the national applications in foreign countries prior to having to incur the filing fees. Although a PCT application is not issued as a patent, it allows the applicant to seek protection in any of the member states through national-phase applications. At the end of the period of two and a half years from the first priority date of the patent application, separate patent applications can be pursued in any of the PCT member states either by direct national filing or, in some cases by filing through a regional patent organization, such as the European Patent Office. The PCT system delays expenses, allows a limited evaluation of the chances of success for national/regional patent applications and enables substantial savings where applications are abandoned within the first two and a half years of filing.
For all patent applications, we determine claiming strategy on a case-by-case basis. Advice of counsel and our business model and needs are always considered. We seek to file patents containing claims for protection of all useful applications of our proprietary technologies and any product candidates, as well as all new applications and/or uses we discover for existing technologies and product candidates, assuming these are strategically valuable. We continuously reassess the number and type of patent applications in our portfolio, as well as the pending and issued patent claims to pursue maximum coverage and value for our processes and compositions, given existing patent office rules and regulations. Further, claims may be narrowed during patent prosecution, to the extent allowed, to meet our intellectual property and business needs.
We recognize that the ability to obtain patent protection and the degree of such protection depends on a number of factors, including the extent of the prior art, the novelty and non-obviousness of the invention, and the ability to satisfy the enablement requirement of the patent laws. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted or further altered even after patent issuance.
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Consequently, we or our licensors may not obtain or maintain adequate patent protection for any of our future product candidates or for our OPTIREACH® technology platform. We cannot predict whether the owned or in-licensed patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents we own or in-license will provide sufficient proprietary protection from competitors. Any patents that we own or in-license may be challenged, circumvented or invalidated by third parties.
The patent positions of biotechnology companies like ours are generally uncertain and involve complex legal, scientific and factual questions. Our commercial success will also depend in part on not infringing upon, misappropriating or otherwise violating the intellectual property or proprietary rights of third parties. Third-party patents could require us to alter our development or commercial strategies, or our product candidates or processes, obtain licenses or cease certain activities. Our breach of any license agreements or our failure to obtain a license to intellectual property or proprietary rights required to develop or commercialize our product candidates or future products may have a material adverse impact on us. If third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference or derivation proceedings in the USPTO to determine priority of invention. For more information, please see the section entitled “Risk Factors—Risks Related to Intellectual Property,” included in Item 3.D. of the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 4, 2026.
In addition to patent protection, we also rely on trademark registration, trade secrets, know how, other proprietary information and continuing technological innovation to develop and maintain our competitive position. As of December 31, 2025, we owned five registered or pending U.S. trademarks (four of which being fractions of international registrations), five international trademark registrations (either granted or still under examination in several countries), 18 registered or pending national foreign trademarks (including the U.S. one). We seek to protect and maintain the confidentiality of proprietary information to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. Thus, we may not be able to meaningfully protect our trade secrets. It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. Our agreements with employees also provide that all inventions conceived by the employee in the course of employment with us or from the employee’s use of our confidential information are our exclusive property. However, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting trade secrets, know-how and inventions. For more information regarding the risks related to our intellectual property, please see the section entitled “Risk Factors—Risks Related to Intellectual Property,” included in Item 3.D. of the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 4, 2026.
When available to expand market exclusivity, our strategy is to obtain, or license additional intellectual property or proprietary rights related to current or contemplated development platforms, core elements of technology and/or clinical candidates.
Government Regulation
Government authorities in the United States at the federal state and local level, and other countries extensively regulate, among other things, the research, development, nonclinical and clinical testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing, and export and import of products such as those we are developing. Generally, before a new drug or biologic can be marketed, considerable data must be generated, which demonstrate the product’s quality, safety, and efficacy. Such data must then be organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory authority.
U.S. Drug and Biologic Development Process
In the United States, the FDA regulates drugs and biologics under the federal FDCA, and its implementing regulations. Biologics are additionally subject to regulations under the Public Health Service Act. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require
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the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, the approval process or after approval may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.
The process required by the FDA before a biopharmaceutical may be marketed in the United States generally involves the following:
Prior to beginning the first clinical trial with a product candidate in the United States, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an IND product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies assessing the toxicology, PK, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site and must monitor the study until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the clinical trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated check points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no
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demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
Phase One: Phase 1 clinical trials are designed to test a new therapy in a small group of people for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify adverse effects). It can include healthy participants or patients.
Phase Two: Phase 2 clinical trials are designed to study an investigational therapy in a larger group of people to determine efficacy and to further evaluate its safety. It is conducted in participants with the condition or disease under study and will determine common short-term adverse effects and risks.
Phase Three: Phase 3 clinical trials are designed to study the efficacy of the investigational therapy in large groups of patients by comparing the therapy to other standard or experimental therapies as well as to monitor adverse effects, and to collect information that will allow the therapy being studied to be used safely.
Post-approval clinical trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA or BLA.
The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. In addition, some clinical trials are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or committee. Depending on its charter, this group may determine whether a clinical trial may move forward at designated check points based on access to certain data from the clinical trial.
During the development of a new biopharmaceutical, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND, at the end of Phase 2, and before an NDA or BLA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development. Sponsors typically use the meetings at the end of the Phase 2 clinical trial to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new drug.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP regulations. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final product. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
While the IND is active and before approval, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected AEs, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.
NDA or BLA Review and Approval Process
Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development nonclinical and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product. The submission of an NDA or BLA is subject to the payment of substantial user fees, although a waiver of such fees may be obtained under certain limited circumstances. Additionally, no user fees are assessed on NDAs or BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.
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The FDA reviews an NDA or BLA to determine, among other things, whether a drug is safe and effective (or a biologic is safe, pure and potent) for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality, and purity. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has a goal of ten months from the date of “filing” of a standard NDA or BLA for a new molecular entity to review and act on the submission. This review typically takes 12 months from the date the NDA or BLA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application is submitted. The FDA conducts a preliminary review of all NDAs or BLAs within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA or BLA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP regulations and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs. If the FDA determines that the application, manufacturing process, or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
After the FDA evaluates an NDA or BLA, it will issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A Complete Response Letter usually describes the specific deficiencies in the application identified by the FDA and may require additional clinical data, such as an additional pivotal Phase 3 clinical trial or other significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing. If a Complete Response Letter is issued, the sponsor must resubmit the application, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information are submitted, the FDA may decide that the application does not satisfy the criteria for approval.
If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the application with a Risk Evaluation and Mitigation Strategy (“REMS”) to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. It could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. The FDA also may offer conditional approval subject to, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product. Orphan product designation must be requested before submitting a BLA. After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.
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Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. Orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity. If a drug or biological product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan product exclusivity. Orphan drug designation status in the EU has similar, but not identical, benefits.
Post-Approval Requirements
Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There are continuing, annual program fees for any marketed products. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP regulations, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP regulations and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain compliance with cGMP regulations and other aspects of regulatory compliance.
The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:
The FDA closely regulates the marketing, labeling, advertising, and promotion of biopharmaceutical products. A company can make only those claims relating to safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties. Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products. The federal government has levied large civil and criminal fines against companies for alleged improper
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promotion of off-label use and has enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labeling.
Marketing Exclusivity
Market exclusivity provisions authorized under the FDCA can delay the submission and approval of certain marketing applications for products containing the same active ingredient. The FDCA permits patent term restoration of up to five years as compensation for a patent term lost during product development and FDA regulatory review process to the first applicant to obtain approval of an NDA for a new chemical entity in the United States. Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not approve or even accept for review an abbreviated new drug application (“ANDA”) or an NDA submitted under Section 505(b)(2) (“505(b)(2) NDA”), submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA by the innovator NDA holder.
The FDCA alternatively provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages, or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to any nonclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.
Pediatric exclusivity is another type of marketing exclusivity available in the United States. Pediatric exclusivity provides for an additional six months of marketing exclusivity attached to another period of exclusivity if a sponsor conducts clinical trials in children in response to a written request from the FDA. The issuance of a written request does not require the sponsor to undertake the described clinical trials. In addition, orphan drug exclusivity, as described above, may offer a seven-year period of marketing exclusivity, except in certain circumstances.
Section 505(b)(2) NDAs
A special type of NDA, commonly referred to as a Section 505(b)(2) NDA, enables the applicant in certain circumstances to rely, in part, on the FDA’s prior findings in approving a similar product or published literature in support of its application. A Section 505(b)(2) NDA may provide an alternate path to FDA approval for a new or improved formulation, a new route of administration, or a new use of a previously approved product. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference. If the Section 505(b)(2) applicant can establish that reliance on the FDA’s prior findings of safety and/or effectiveness is scientifically appropriate, it may eliminate the need to conduct certain preclinical or clinical studies of the new product. The FDA may also require companies to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new product candidate for all, or some, of the indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant. If we choose to rely on the 505(b)(2) process to seek approval for OCS-01, there can be no assurance that the FDA will agree with our use of that pathway.
To the extent that the Section 505(b)(2) applicant is relying on the FDA’s prior findings of safety or effectiveness for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would. Thus, approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired, and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section 505(b)(2) applicant.
FDA Approval and Regulation of Companion Diagnostics
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A therapeutic product may rely upon an in vitro companion diagnostic for use in selecting the patients that will be more likely to respond to that therapy. If the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product or indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic device is not approved or cleared for that indication. Approval or clearance of the companion diagnostic device will ensure that the device has been adequately evaluated and has adequate performance characteristics in the intended population. The review of in vitro companion diagnostics in conjunction with the review of our therapeutic product candidate Licaminlimab (OCS-02) will, therefore, likely involve coordination of review by the FDA’s Center for Biologics Evaluation and Research and the FDA’s Center for Devices and Radiological Health.
Under the FDCA, in vitro diagnostics, including companion diagnostics, are regulated as medical devices. In the United States, the FDCA and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medical device design and development, preclinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and distribution, export and import, and post-market surveillance. Unless an exemption applies, diagnostic tests require marketing clearance or approval from the FDA prior to commercial distribution. The three primary types of FDA marketing authorization applicable to a medical device include premarket notification, also called 510(k) clearance, premarket approval (“PMA”), and de novo classification requests.
EU/Rest of World Regulation
Conduct of Clinical Trials in the EU
In addition to regulations in the United States, there are a variety of regulations in other jurisdictions governing, among other things, clinical trials, commercial sales and distribution of medicinal products. Even if FDA approval of a particular product is obtained, it must still obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement of human clinical trials.
In the EU, the Clinical Trials Regulation (EU) No 536/2014 entered into application on January 31, 2022. The Regulation is intended to harmonize and streamline clinical trial authorizations, simplify adverse-event reporting procedures, improve the supervision of clinical trials and increase their transparency. Specifically, the new Regulation, which is directly applicable in all EU Member States, introduces a streamlined application procedure via a single entry point, the “EU portal,” the Clinical Trials Information System (“CTIS”); a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors. A harmonized procedure for the assessment of applications for clinical trials has been introduced and is divided into two parts. Part I is assessed by the competent authorities of a reference member state selected by the trial sponsor largely of the type of clinical trial, risk-benefit analysis, and compliance with technical requirements. This assessment is then submitted to the competent authorities of all the concerned member states in which the trial is to be conducted for their review. Part II is assessed separately by the competent authorities and ECs in each EU member state concerned. Individual EU Member States shall retain the power to authorize the conduct of clinical trials on their territory. The CTR foresaw a three-year transition period that ended on January 31, 2025. Since this date, all new or ongoing trials are subject to the provisions of the CTR.
Pathways to Obtain a Marketing Authorization in the EU
In the European Economic Area, which consists of the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein, medicinal products can only be commercialized after a related marketing authorization has been granted. A company may submit an MAA on the basis of the centralized, decentralized or mutual recognition procedure. Under the centralized procedure, MAAs are submitted to the EMA for scientific review by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”). The CHMP issues an opinion concerning whether the quality, safety and efficacy of the product has been demonstrated. The opinion is considered by the European Commission which is responsible for granting a centralized marketing authorization in the form of a binding European Commission decision. If the application is approved, the European Commission grants a single marketing authorization that is valid throughout the EEA. The centralized procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the European Union.
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National marketing authorizations, which are issued by the competent authorities of EEA countries and only cover their respective territory, are available for products not falling within the mandatory scope of the centralized procedure. Where a product has already been authorized for marketing in an EEA country, this national marketing authorization can be recognized in another EEA country through the mutual recognition procedure. The mutual recognition procedure provides for the EEA countries selected by the applicant to mutually recognize a national marketing authorization that has already been granted by the competent authority of another EEA country, referred to as the Reference Member State (“RMS”). The decentralized procedure is used when the product in question has yet to be granted a marketing authorization in any EEA country. Under this procedure the applicant can select the EEA country that will act as the RMS. In both the mutual recognition and decentralized procedures, the RMS reviews the application and submits its assessment of the application to the EEA countries for which marketing authorizations are being sought, referred to as Concerned Member States.
Within 90 days of receiving the application and assessment report, each Concerned Member State must decide whether to recognize the RMS assessment or reject it on the basis of potential serious risk to public health. If the disputed points cannot be resolved, the matter is first referred to the Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralized Procedures for agreement. If the Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralized Procedures cannot reach an agreement, a referral is made to the EMA. The CHMP will provide an opinion that will form the basis of a decision to be issued by the European Commission that is binding on all EEA countries. If the application is successful during the decentralized or mutual recognition procedure, national marketing authorizations will be granted by the competent authorities in each of the EEA countries chosen by the applicant.
In principle, a marketing authorization has an initial validity of five years. The marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the EEA country in which the original marketing authorization was granted. To support the application, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the eCTD (Common Technical Document) providing up to date data concerning the quality, safety and efficacy of the product, including all variations introduced since the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid. The European Commission or the competent authorities of the EEA countries may decide, on justified grounds relating to pharmacovigilance, to proceed with one further five year renewal period for the marketing authorization. Once subsequently definitively renewed, the marketing authorization shall be valid for an unlimited period. Any authorization which is not followed by the actual placing of the medicinal product on the EU market (in case of centralized procedure) or on the market of the authorizing EEA country within three years after authorization ceases to be valid (the so-called sunset clause).
In the EU, conditional marketing authorizations may be granted in the centralized procedure for a limited number of medicinal products for human use in cases where the related clinical dataset is not yet complete. A conditional marketing authorization may be granted for a medicinal product, if (i) the risk-benefit balance of the product is positive, (ii) it is likely that the applicant will be in a position to provide the required comprehensive data after the authorization, (iii) the medicinal product fulfills unmet medical needs and (iv) the benefit to public health of the immediate availability on the market of the medicinal product outweighs the risk inherent in the fact that additional data are still required. The authorization is valid for one year and must be renewed annually until all related conditions have been fulfilled. Once any pending studies are provided, the conditional marketing authorization can be converted into a traditional marketing authorization. However, if the conditions are not fulfilled within the timeframe set by the EMA, the marketing authorization will cease to be renewed.
A marketing authorization may also be granted “under exceptional circumstances” where the applicant can show that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced. These circumstances may arise in particular when the intended indications are very rare and, in the state of scientific knowledge at that time, it is not possible to provide comprehensive information, or when generating data may be contrary to generally accepted ethical principles. Like a conditional marketing authorization, a marketing authorization granted in exceptional circumstances is reserved to medicinal products intended to be authorized for treatment of rare diseases or unmet medical needs for which the applicant does not hold a complete data set that is required for the grant of a standard marketing authorization. However, unlike the conditional marketing authorization, an applicant for authorization in exceptional circumstances is not subsequently required to provide the missing data. Although the marketing authorization “under exceptional circumstances” is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually and the marketing authorization is withdrawn in case the risk-benefit ratio is no longer favorable.
Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines (“PRIME”), scheme, which provides incentives similar to the Breakthrough Therapy designation in the U.S. PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicinal products that target unmet medical needs. It permits increased interaction and early dialogue with companies developing promising medicinal products, to optimize their product development plans and speed up their evaluation to help the product reach patients earlier than normal. Product
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developers that benefit from PRIME designation are potentially eligible for accelerated assessment of their MAA although this is not guaranteed. Benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.
In addition to an MAA, various other requirements apply to the manufacturing and placing on the EU market of medicinal products. Manufacture of medicinal products in the EU requires a manufacturing authorization, and import of medicinal products into the EU requires a manufacturing authorization allowing for import. The manufacturing authorization holder must comply with various requirements set out in the applicable EU laws, regulations and guidance. These requirements include compliance with EU GMP standards when manufacturing medicinal products and APIs, including the manufacture of APIs outside of the EU with the intention to import the APIs into the Union. Similarly, the distribution of medicinal products within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU member states. Marketing authorization holders and/or manufacturing and import authorization (MIA) holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in case of non-compliance with the EU or EU member states’ requirements applicable to the manufacturing of medicinal products.
Data and Market Exclusivity
In the EU, innovative medicinal products that are subject to marketing authorization on the basis of a full dossier and do not fall within the scope of the concept of global marketing authorization qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity. The concept of global marketing authorization prevents the same marketing authorization holder or members of the same group, or companies that have concluded tacit or explicit agreements concerning the marketing of the same medicinal product, from obtaining separate data and market exclusivity periods for medicinal products that contain the same active substance. Data exclusivity, if granted, prevents regulatory authorities in the European Union from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product, after which a generic or biosimilar marketing authorization application can be submitted, and the innovator’s data may be referenced. However, the generic product or biosimilar products cannot be marketed in the EU for a further two years thereafter. The overall ten-year period may be extended for a further year to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
Pediatric Development
In the EU, Regulation (EC) No 1901/2006 provides that all MAAs for new medicinal products must include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (“PIP”), agreed with the EMA’s Pediatric Committee (“PDCO”). The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the medicinal product for which marketing authorization is being sought. The PDCO may grant a deferral of the obligation to implement some or all of the measures provided in the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Furthermore, the obligation to provide pediatric clinical trial data can be waived by the PDCO when these data are not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the marketing authorization is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible for a six-month extension to the Supplementary Protection Certificate or SPC if any is in effect at the time of authorization or, in the case of orphan medicinal products, a two-year extension of orphan market exclusivity. For other countries outside of the European Union, such as certain countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product approval, pricing and reimbursement vary from country to country. In all cases, the clinical trials are to be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Orphan Medicinal Products
Regulation (EC) No. 141/2000, as implemented by Regulation (EC) No. 847/2000 provides that a medicinal product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish that: (i) the product is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions; (ii) either (a) such conditions affect not more than 5 in 10,000 persons in the EU when the application is made, or (b) the product without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary
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investment in developing the medicinal product; and (iii) there exists no satisfactory authorized method of diagnosis, prevention, or treatment of the condition that has been authorized in the EU, or even if such method exists, the product will be of significant benefit to those affected by that condition.
Orphan medicinal product designation entitles an applicant to incentives such fee reductions or fee waivers, protocol assistance, and access to the centralized marketing authorization procedure. Upon grant of a marketing authorization, orphan medicinal products are entitled to a ten-year period of market exclusivity for the approved therapeutic indication, which means that the EMA cannot accept another marketing authorization application, or grant a marketing authorization, or accept an application to extend a marketing authorization for a similar product for the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, a marketing authorization may be granted to a similar medicinal product with the same orphan indication during the 10 year period if: (i) if the applicant consents to a second original orphan medicinal product application; (ii) if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities; or (iii) if the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior to the original orphan medicinal product. A company may voluntarily remove a product from the register of orphan products.
Post-Approval Requirements
Where a marketing authorization is granted in relation to a medicinal product in the EU, the holder of the marketing authorization is required to comply with a range of regulatory requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products.
Similar to the United States, both marketing authorization holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the competent regulatory authorities of the individual EEA countries. The holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).
All new marketing authorization applications must include a risk management plan (“RMP”), describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.
In the EU, the advertising and promotion of medicinal products are subject to both EU and EEA countries laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in each member state and can differ from one country to another. For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s SmPC, as approved by the competent authorities in connection with a marketing authorization. The SmPC is the document that provides information to physicians concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU. Direct-to-consumer advertising of prescription medicinal products is also prohibited in the EU.
Regulation of Companion Diagnostics in the EU
In the EU, despite the absence of a legal definition, companion diagnostics are deemed to be in vitro diagnostic medical devices and are governed by Directive 98/79/EC (“IVDD”). The IVDD currently regulates the placing on the market, the CE-marking, the essential requirements, the conformity assessment procedures, the registration obligations for manufacturers and devices as well as the vigilance procedure related to such products. In vitro diagnostic medical devices,
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including companion diagnostics, must comply with the requirements provided for in the IVDD, and with further requirements implemented at national level (as the case may be).
In vitro diagnostic medical devices (including companion diagnostics) are currently required to conform with the essential requirements of the IVDD. To demonstrate compliance with the essential requirements laid down in Annex I to the IVDD, the manufacturer must conduct a conformity assessment procedure.
For general in vitro diagnostic medical devices (i.e. all IVDs other than those covered by Annex II to the IVDD and IVDs for self-testing), the conformity assessment is performed through a self-assessment of the manufacturer without the intervention of a notified body which is an independent organization designated by the competent authorities of an EU member state to assess the conformity of devices before being placed on the market. The manufacturer must prepare an EC Declaration of Conformity confirming conformity of its products with the essential requirements laid down in the IVDD before placing the product on the EU market.
By contrast, the conformity assessment of in vitro diagnostic medical devices for self-testing or that are listed in Annex II (i.e. essentially moderate and high risk reagents and reagent products) to the IVDD requires the intervention of a notified body. Following successful completion of a conformity assessment procedure the notified body will issue a CE Certificate of Conformity. The device manufacturer may, after having completed remaining related procedures and obligations, affix the CE mark to its medical device after having prepared and signed a related EC Declaration of Conformity.
The regulation of companion diagnostics has been subject to further requirements since the in vitro diagnostic medical devices Regulation (No 2017/746), (“IVDR”), became applicable on May 26, 2022. The IVDR introduced a new classification system for companion diagnostics which are now specifically defined as diagnostic tests that support the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment. Companion diagnostics have to undergo a conformity assessment by a notified body. If the medicinal product has, or is in the process of, been authorized through the centralized procedure for the authorization of medicinal products, the notified body is, before it can issue a CE Certificate of Conformity, required to seek a scientific opinion from the EMA on the suitability of the companion diagnostic for use in relation to the medicinal product concerned. For medicinal products that have or are in the process of authorization through any other route provided in EU legislation, the notified body must seek the opinion of the national competent authority of an EU Member State.
Other Healthcare Laws
Pharmaceutical manufacturers are subject to additional healthcare laws, regulation, and enforcement by the U.S. federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation:
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These laws and regulations are subject to change, which can increase the resources needed for compliance and delay drug approval or commercialization. Any action brought against us for violations of these laws or regulations, even successfully defended, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Also, we may be subject to private “qui tam” actions brought by individual whistleblowers on behalf of the federal or state governments. Actual or alleged violation of any such laws or regulations may lead to investigations and other claims and proceedings by regulatory authorities and in certain cases, private actors, and violation of any of such laws or any other governmental regulations that apply may result in penalties, including, without limitation, significant administrative, civil and criminal penalties, damages, fines, disgorgement, additional reporting obligations, and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, the curtailment or restructuring of operations, exclusion from participation in government healthcare programs and imprisonment.
The collection and use of personal health data in the EEA is governed by the GDPR ((EU) 2016/679), which became effective May 25, 2018. The GDPR applies to any company established in the EEA and to companies established outside the EEA that process personal data in connection with the offering of goods or services to data subjects in the EU or the monitoring of the behavior of data subjects in the EU. The GDPR enhances data protection obligations for controllers and processors of personal data, including stringent requirements relating to the consent of data subjects, expanded disclosures about how personal data is used, requirements to conduct privacy impact assessments for high-risk processing, limitations on retention of personal data and mandatory data breach notification and privacy by design requirements, and creates direct obligations on service providers acting as data processors. The GDPR also imposes strict rules on the transfer of personal data out of the EEA to countries that do not ensure the same level of protection, such as the United States. Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA countries may result in fines
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up to 20 million Euros or 4.0% of a company’s global annual revenues for the preceding financial year, whichever is higher. Moreover, the GDPR grants data subjects the right to claim compensation for damages resulting from infringement of the GDPR.
Coverage and Reimbursement
Sales of any pharmaceutical product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance, and managed healthcare organizations, and the level of reimbursement for such product by third-party payors. Significant uncertainty exists as to the coverage and reimbursement status of any newly approved product. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. One third-party payor’s decision to cover a particular product does not ensure that other payors will also provide coverage for the product. As a result, the coverage determination process can require manufacturers to provide scientific details, information on cost-effectiveness, and clinical support for the use of a product to each payor separately. This can be a time-consuming process, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. In addition, third-party payors are increasingly reducing reimbursements for pharmaceutical products and related services. The U.S. government and state legislatures have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Third-party payors are increasingly challenging the prices charged, examining the medical necessity and reviewing the cost-effectiveness of pharmaceutical products, in addition to questioning their safety and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. For example, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven (7) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.
In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Pharmaceutical products may face competition from lower-priced products in foreign countries that have placed price controls on pharmaceutical products and may also compete with imported foreign products. Furthermore, there is no assurance that a product will be considered medically reasonable and necessary for a specific indication, that it will be considered cost-effective by third-party payors, that an adequate level of reimbursement will be established even if coverage is available, or that the third-party payors’ reimbursement policies will not adversely affect the ability for manufacturers to sell products profitably.
Healthcare Reform
In the United States and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system. In March 2010, the ACA was signed into law, which substantially changed the way healthcare is financed by both governmental and private insurers in the United States. For example, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (or collectively, the “ACA”), substantially affects the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. For example, on July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.
Since its enactment, there have been amendments to and executive, judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future.
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Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of up to 2.0% per fiscal year, effective April 1, 2013, which, due to subsequent legislative amendments, will stay in effect until 2032 unless additional congressional action is taken.
Additional health reform measures may continue and affect our business in unknown ways, particularly given the recent change in administration. The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform (“TrumpRx”), U.S. patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives; (3) imposing tariffs on imported pharmaceutical products; and (4) as part of the Make America Healthy Again (“MAHA”) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager (“PBM”) payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, the U.S. Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could materially and adversely affect our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates or put pressure on our product pricing.
On January 12, 2025, Regulation No 2021/2282 on Health Technology Assessment (HTA Regulation), entered into application through a phased implementation. The Regulation initially applies to new active substances for oncology and ATMPs. It will be expanded to orphan medicinal products in January 2028, and to all centrally authorized medicinal products as of 2030. Select high-risk medical devices also came into scope in 2026. The HTA Regulation is intended to boost cooperation among Member States in assessing health technologies, including new medicinal products. The Regulation establishes a framework for EU‑level joint clinical assessments, joint scientific consultations, and the early identification of emerging health technologies. The Regulation permits EU Member States to use common tools, methodologies, and procedures and requires them to rely on EU‑level joint clinical assessment reports for the clinical components of their national HTA evaluations. Individual EU Member States will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.
C. Organizational Structure
Oculis Holding AG is a stock corporation (Aktiengesellschaft) with its registered office at Bahnhofstrasse 20, CH-6300, Zug, Switzerland. It was incorporated under the laws of Switzerland on October 31, 2022. Our official seat is planned to remain in Zug, Switzerland.
As of December 31, 2025, we controlled seven wholly-owned subsidiaries: Oculis Operations Sàrl (“Oculis Operations”) with its registered office in Lausanne, Switzerland, which was incorporated on December 27, 2022, Oculis ehf. (“Oculis Iceland”), which was incorporated in Reykjavik, Iceland on October 28, 2003, Oculis France Sàrl (“Oculis France”) which was incorporated in Paris, France on March 27, 2020, Oculis US, Inc. which was incorporated in Delaware, USA on May 26, 2020, Oculis HK, Limited (“Oculis HK”) which was incorporated in Hong Kong, China on June 1, 2021, Neurocol IP Sàrl with its registered office in Lausanne, Switzerland, which was incorporated on December 4, 2025, and Neurocol Operations Sàrl, with its registered office in Lausanne, Switzerland, which was incorporated on December 4, 2025. The
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Company and its wholly-owned subsidiaries form the Oculis Group (the “Group”). Prior to the Business Combination on March 2, 2023, Oculis SA (“Legacy Oculis”), which was incorporated on December 11, 2017, and had its registered office in Lausanne, Switzerland, and its wholly-owned subsidiaries Oculis Iceland, Oculis France, Oculis U.S. and Oculis HK, formed the Oculis group. On July 6, 2023, Legacy Oculis merged with and into Oculis Operations, and the separate corporate existence of Legacy Oculis ceased. Oculis Operations is the surviving entity and remains a wholly-owned subsidiary of Oculis.
On April 18, 2024, we completed the dissolution of Oculis Merger Sub II Company (“Merger Sub 2”) which was incorporated in the Cayman Islands on January 3, 2023 and was a wholly-owned subsidiary of Oculis. Merger Sub 2 was created for purposes of consummating the Business Combination and did not contain any of our business operations.
D. Property and Equipment
As of December 31, 2025, we leased approximately 14,500 square feet of facilities for our operations, including 4,300 square feet of laboratory and office space in Iceland, with main activities of research, business and clinical development, 4,630 square feet of office space in Switzerland, with main activities of business and clinical development and 5,575 square feet of office space in the United States, with main activities being general and administrative in nature. We believe that these facilities will be adequate to meet our needs, and we are constantly evaluating our needs for expanding and or adding to our existing facilities.
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Financial Review
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Operating and Financial Review and Prospects
Certain information called for by this section "Operating and Financial Review and Prospects", including a discussion of the year ended December 31, 2023, as well a comparison of the year ended December 31, 2024 against the year ended December 31, 2023, has been reported previously in our Annual Report on Form 20-F for the year ended December 31, 2024 filed on March 11, 2025 under Item 5. “Operating and Financial Review and Prospects.”
All amounts discussed, aside from share data, are in Swiss francs and presented in thousands, unless otherwise indicated.
Company Overview
We are a global late clinical-stage biopharmaceutical company, headquartered in Switzerland with operations in Switzerland, the U.S. and Iceland. We have substantial expertise in therapeutics for the treatment of neuro-ophthalmic and ophthalmic diseases. We intend to become a leader in developing innovative therapeutics to address neuro-ophthalmic and ophthalmic diseases characterized by significant medical needs with large market opportunities. To accomplish this objective, we plan to focus on successful completion of our key strategic initiatives. For the ophthalmic franchise, we are focused on advancing the clinical and regulatory plans of OCS-01 to bring a first-in-class topical eye drop therapy for the treatment in DME and developing Licaminlimab for precision medicine for DED. Furthermore, we are advancing the development of Privosegtor in ON and NAION, and exploring additional broader indications in neuro-ophthalmology.
Our pipeline currently includes three clinical-stage therapeutic candidates: OCS-01, Licaminlimab (OCS-02) and Privosegtor (OCS-05). OCS-01 is an eye drop candidate which aims to be the first non-invasive topical treatment for DME. It is presently being evaluated in two ongoing Phase 3 clinical trials for DME, with topline results expected in the second quarter of 2026. Licaminlimab is a product candidate for the treatment of keratoconjunctivitis sicca, or dry eye disease (“DED”), which we are advancing with a precision medicine approach. After a successful FDA meeting in the first quarter of 2025, we initiated the PREDICT-1 registrational Phase 2/3 trial with a genotype-based approach to investigate Licaminlimab in DED in the fourth quarter of 2025 for which topline results are expected in the fourth quarter of 2026. Privosegtor is a neuroprotective candidate that has the potential to become a novel therapy for optic neuritis (“ON”), non-arteritic anterior ischemic optic neuropathy (“NAION”), potentially other neuro-ophthalmic diseases, neurological diseases and beyond. Following a successful meeting with the FDA in the third quarter of 2025, we advanced Privosegtor into a registrational program called PIONEER for ON and NAION.
Numerous diseases and disorders, many of which represent significant medical needs, are associated with the human eye. The National Eye Institute, a part of the U.S. National Institutes of Health, estimates that in the United States, blindness or significant visual impairment impacts approximately seven million people, including those with vision loss resulting from retinal diseases such as DME, macular degeneration, DR, and RVO; disorders caused by swelling and inflammation such as DED; and glaucoma, among other disease states. For glaucoma more specifically, the American Glaucoma Society highlighted a tremendous unmet need for therapies, independent of intraocular pressure (IOP) lowering agents, that can offer neuroprotection, neurorecovery and/or neuroregeneration. Of note, retinal neuroprotection has been considered the next frontier in ophthalmic disease as the discovery of novel neuroprotection strategies will fill a critical unmet need for multiple neuro-ophthalmic conditions. It is estimated that the global spending for ophthalmology therapeutics will reach approximately $33 billion in 2027, according to an industry source.
To date, we have primarily financed our operations through the proceeds from share issuances and grants. We have no products approved for commercialization and have never generated any revenues from product sales. Pharmaceutical and biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. It may be several years, if ever, before we have a product candidate approved for commercialization, and we begin to generate revenue and royalties from product sales. We have also incurred significant operating losses. We incurred net losses of CHF 99.0 million for the year ended December 31, 2025, and had accumulated losses of CHF 384.5 million as of December 31, 2025.
Factors Affecting Our Performance
Business Environment
The biopharmaceutical industry is extremely competitive. We are subject to risks and uncertainties common to any clinical-stage biopharmaceutical company. These risks include, but are not limited to, the introduction of new products, therapies, standards of care or technological innovations, our ability to obtain, maintain, protect and enforce our licensed technology, data and other intellectual property and proprietary rights and compliance with extensive government regulation and oversight. Please see the section entitled “Risk Factors” included in Item 3.D. of the Annual Report on Form 20-F for the
45
year ended December 31, 2025 filed with the SEC on March 4, 2026. We are also dependent upon the services of key personnel, including our Chief Executive Officer, executive team and other highly skilled employees. Demand for experienced personnel in the pharmaceutical and biotechnology industries is high and competition for talent is intense.
We face potential competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions and governmental agencies as well as public and private research institutions. Many of our competitors are working to develop or have commercialized products similar to those we are developing and have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products. Our competitors may also have significantly greater financial resources, established presence in the markets in which we hope to compete, expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and registering patients for clinical trials, entering into agreements with CMOs for the manufacture of our product candidates, as well as in acquiring technologies complementary to, or necessary for, our programs.
Business combination with European Biotech Acquisition Corp (“EBAC”)
On March 2, 2023, we consummated a business combination with EBAC (the “Business Combination”) pursuant to the Business Combination Agreement (“BCA”) between Legacy Oculis and EBAC dated as of October 17, 2022. We received gross proceeds of CHF 97.6 million or $103.7 million comprising CHF 12.0 million or $12.8 million of cash held in EBAC’s trust account and CHF 85.6 million or $90.9 million from private placement (“PIPE”) investments and conversion of notes issued under Convertible Loan Agreements (“CLA”) into our ordinary shares. As a result of the transaction, each issued and outstanding EBAC public warrant (“BCA Public Warrants”) and EBAC private placement warrant (“BCA Private Warrants”) ceased to be a warrant with respect to EBAC ordinary shares and were assumed by Oculis as warrants with respect to ordinary shares on substantially the same terms (the BCA Public Warrants and the BCA Private Warrants collectively the “Warrants”). In connection with the Business Combination, Oculis became listed on the United States Nasdaq Global Market with the ticker symbol “OCS” for its ordinary shares and “OCSAW” for its public warrants.
Earnout consideration
As a result of the BCA, Legacy Oculis preferred, ordinary and option holders (collectively “equity holders”) received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01.
The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post acquisition-closing share volume weighted average price targets of $15.00, $20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028 (the “Earnout Period”). A given share price target described above will also be deemed to be achieved if there is a change of control, as defined in the BCA, during the Earnout Period.
The price targets of $15.00, $20.00 and $25.00 were met in November 2024, February 2025 and February 2026, respectively, resulting in an aggregate of 2,845,446 earnout shares vested and 159,453 earnout options outstanding and exercisable as of December 31, 2025, and an additional 948,549 earnout shares vested and 55,487 earnout options becoming exercisable in February 2026.
May 2023 Public Offering
On May 31, 2023, we entered into an underwriting agreement with BofA Securities Inc. and SVB Securities, LLC, as representatives of several underwriters. On June 5, 2023 and June 13, 2023, we closed a public offering for the aggregate issuance and sale of 3,654,234 ordinary shares at a price of CHF 10.45 or $11.50 per share, for total gross proceeds of CHF 38.2 million or $42.0 million before deducting underwriting discounts, commissions and offering expenses.
Registered Direct Offering and Nasdaq Iceland Main Market listing
On April 22, 2024, we closed a registered direct offering with gross proceeds of CHF 53.5 million or $58.8 million through the issuance and sale of 5,000,000 of our ordinary shares, at a purchase price of CHF 10.70 or $11.75 per share, and commenced trading of our ordinary shares on the Nasdaq Iceland Main Market under the ticker symbol “OCS” on April 23, 2024.
46
At-the-Market Offering Program
On May 8, 2024, we entered into a sales agreement with Leerink Partners, LLC (“Leerink Partners”) with respect to an at-the-market offering program (the “ATM Offering Program”) under which we may offer and sell, from time to time at our sole discretion, ordinary shares having an aggregate offering price of up to $100.0 million (CHF 79.3 million) through Leerink Partners as our sales agent. On October 29, 2025, in conjunction with the November 2025 Underwritten Offering, discussed below, the Company suspended and terminated the ATM Offering Program. As of the date hereof, we have not sold any ordinary shares under the ATM Offering Program. We will not make any sales of our ordinary shares pursuant to the sales agreement unless and until a new prospectus, prospectus supplement or registration statement is filed. Other than the termination of the ATM Offering Program, the sales agreement remains in full force and effect.
Loan Facility
On July 31, 2025, the Company entered into an amended and restated agreement for its existing loan facility (the “Amended Loan Agreement”) with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by BlackRock, Inc. The Amended Loan Agreement replaces the prior loan agreement between the Company and the Lender dated May 29, 2024, with an upsized structure to provide the EUR equivalent of up to CHF 75.0 million in borrowing capacity (which may be increased to up to CHF 100.0 million) (the “Loan”), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 25.0 million each, as well as an additional loan of the EUR equivalent of up to CHF 25.0 million, which may be made available by the Lender to the Company if mutually agreed in writing by the Lender and the Company. No amounts were drawn under the Amended Loan Agreement during the year ended December 31, 2025.
Loan 1 will be available for drawdown from closing until November 15, 2026, which period may be shortened upon the occurrence of a development milestone. Loans 2 and 3 will be available for drawdown prior to November 15, 2026 and December 31, 2026, respectively, in each case subject to satisfaction of certain pre-specified conditions. The availability of any funds under a drawdown of Loans 1, Loan 2 or Loan 3 is conditional upon, together with other conditions, the Company having a debt-to-market cap ratio (where debt includes the amount of all amounts drawn down to date and the proposed drawdown) equal to or less than 15% at the time of each draw down.
Borrowings under Loan 1, 2 and 3 will bear interest at a fixed rate (cash and PIK) of 9.7%, 9.6% and 9.5% per annum, respectively. The Loan will have an interest-only period of, in respect of Loans 1, 2 and 3, from the relevant drawdown date until December 31, 2027, March 31, 2028 and June 30, 2028, respectively. The interest-only periods for each of Loans 1 and 2 will be shortened to December 31, 2026 if certain conditions are not met. In the event the interest-only periods for Loans 1 and 2 are shortened, Loans 1 and 2 will mature on 30 June 2029. In the event the interest-only periods are not shortened, Loans 1, 2 and 3 will expire on 31 December 2029.
The Company may prepay all, but not part, of the term loan amounts at any time other than, unless the Lender agrees otherwise, by notifying the Lender in advance. The Loan is subject to mandatory prepayment in the event of a change of control or specified asset dispositions or licenses, subject to certain exceptions and thresholds. There are additional fees (including prepayment premia) payable to the Lender in the event the loan is prepaid either mandatorily or voluntarily. The Lender received a restatement fee of CHF 0.5 million in connection with the Amended Loan Agreement. The Lender is eligible to receive an aggregate of approximately CHF 0.6 million in additional transaction fees payable upon the Company’s eligibility to receive and actual receipt of future drawdowns. The Lender will be eligible to receive certain non-utilisation fees. On the date on which the Loan is prepaid or falls due for repayment in full, the Lender is eligible to receive an end of loan fee of, in relation to each of Loans 1, 2 and 3, 4.5% of the amount drawn down under the relevant loan. The Loan contains customary affirmative and negative covenants.
As additional consideration for the Loan, Kreos Capital VII Aggregator SCSp, an affiliate of the Lender (the “Holder”), and the Company entered into an amended warrant (the “Amended Warrant”) to purchase up to 494,259 of the Company’s ordinary shares, subject to vesting, at a price per ordinary share equal to $12.17 with respect to 361,011 shares from the prior warrant agreement, and $18.64 with respect to the remaining 133,248 shares reflecting the upsized facility, subject to adjustment. The Amended Warrant amends the prior warrant issued to Holder on May 29, 2024. As of the signing date, the Amended Warrant is exercisable for 59,310 ordinary shares, of which 43,321 shares were previously granted. Following the drawdown of each of Loans 1, 2 and 3, the Amended Warrant will become exercisable for additional amounts of ordinary shares ratably based on the amounts of Loans 1, 2 and 3 that are drawn. Each tranche of the Amended Warrant will be exercisable for a period of up to seven years from the date of vesting and the Amended Warrant will terminate at the earliest of (i) December 31, 2033, (ii) such earlier date on which the Amended Warrant is no longer exercisable for any warrant shares in accordance with its terms and (iii) the acceptance by the Company’s shareholders of a third-party bona fide offer for all outstanding shares of the Company (subject to any prior exercise by the Holder, if applicable). The Amended Warrant also includes customary F-3 resale and piggyback registration rights and anti-dilution provisions.
47
The Amended Warrant had not been exercised in part or in full as of December 31, 2025.
February 2025 Underwritten Offering
On February 14, 2025, we entered into an underwriting agreement with BofA Securities Inc. and Leerink Partners LLC, as a representative of the several underwriters in connection with an offering of 5,000,000 of our ordinary shares, CHF 0.01 nominal value per share, at a price of $20.00 (CHF 18.05) per share, for total gross proceeds of $100.0 million (CHF 90.2 million), before deducting underwriting discounts, commissions and offering expenses. The offering closed on February 18, 2025.
November 2025 Underwritten Offering and Registered Direct Offering
On November 3, 2025, we closed offerings of an aggregate of 5,432,098 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.25 (CHF 16.33) per share for total gross proceeds of $110.0 million (CHF 88.7 million) before deducting underwriting discounts, commissions and offering expenses. This offering was carried out with 2,635,801 shares out of the Company’s existing capital band and 2,796,297 shares previously held in treasury by the Company.
Components of Results of Operations
Revenue
We have not generated any revenue from product sales since our inception and do not expect to generate any revenue from the sale of products in the near future. If our development efforts for our product candidates are successful and result in regulatory approval or if we enter into collaboration or licensing agreements with third parties, we may generate revenue in the future from a combination of product sales and payments from such collaboration or licensing agreements. However, there can be no assurance as to when we will generate such revenue, if at all.
Grant Income
Grant income reflects reimbursement of research and development expenses and income from certain research projects managed by Icelandic governmental institutions. We maintain a subsidiary in Iceland that provides research and development for our product candidates. Certain expenses qualify for incentives from the Icelandic government in the form of tax credits or cash reimbursements. We do not anticipate generating significant grant income in the near future.
Operating Expenses
Research and Development expenses
Research and development expenses consist primarily of costs incurred in connection with the research and development of our product candidates and programs. We expense research and development costs and the cost of acquired intangible assets used in research and development activities as incurred. Research and development expenditures are capitalized only if they meet the recognition criteria of IAS 38 (“Intangible Assets”). Capitalization does not result in amortization until the related product is approved for commercialization, where a finite useful economic life can be more reliably determined. To date, all capitalized R&D intangible assets remain unamortized.
Research and development expenses include:
48
For the years ended December 31, 2025 and 2024, no research and development costs were capitalized by the Company.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our ongoing and planned clinical development activities in the near term and in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any current or future product candidates.
General and Administrative expenses
General and administrative expenses consist primarily of internal and external costs related to executive management, finance and accounting functions, legal, business development, corporate insurance, corporate and investor communications, pre-commercial and other administrative functions and operating costs.
Finance Income (Expense)
Finance income (expense) consists primarily of interest income on fixed term deposits.
Fair value adjustment on warrant liabilities
Fair value adjustment on warrant liabilities reflects the changes in fair value of our warrant instruments. The fair value of our public and private placement warrants (“BCA Warrants”) is dependent on the change in the underlying market price of the public warrants and the number of outstanding warrants at the reporting date. This fair value is, in general, directly correlated with the market price of our warrants. Assuming the number of outstanding warrants remains constant, we would expect a fair value loss due to an increase in the market price of the warrants, and a fair value gain due to a decrease in the market price of the warrants. The fair value of the BlackRock Warrant is dependent on the change in the Black-Scholes fair value and the number of outstanding warrants at the reporting date.
Foreign Currency Exchange Gain (Loss)
Foreign currency exchange gains and losses consist of currency exchange differences that arise from transactions denominated in currencies other than Swiss Francs.
Income Tax Expense
We are subject to corporate Swiss federal, cantonal and communal taxation, respectively, in Switzerland, Canton of Zug, and Commune of Zug, as well as in the Canton of Vaud, and Commune of Lausanne. We are also subject to taxation in other jurisdictions in which we operate, in particular the United States, France, Hong Kong and Iceland where our wholly owned subsidiaries are incorporated.
We are entitled, under Swiss laws, to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes owed. As of December 31, 2025, we had tax loss carry-forwards totaling CHF 106.9 million. There is no certainty that we will make sufficient profits to be able to utilize tax loss carry-forwards in full and no deferred tax assets have been recognized in the financial statements.
49
A. Operating Results
The following table summarizes our results of operations for the periods presented:
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
Grant income |
|
1,199 |
|
|
|
686 |
|
|
|
513 |
|
|
|
74.8 |
% |
Operating income |
|
1,199 |
|
|
|
686 |
|
|
|
513 |
|
|
|
74.8 |
% |
Research and development expenses |
|
(57,085 |
) |
|
|
(52,083 |
) |
|
|
(5,002 |
) |
|
|
(9.6 |
%) |
General and administrative expenses |
|
(25,786 |
) |
|
|
(21,807 |
) |
|
|
(3,979 |
) |
|
|
(18.2 |
%) |
Operating expenses |
|
(82,871 |
) |
|
|
(73,890 |
) |
|
|
(8,981 |
) |
|
|
(12.2 |
%) |
Operating loss |
|
(81,672 |
) |
|
|
(73,204 |
) |
|
|
(8,468 |
) |
|
|
(11.6 |
%) |
Finance income |
|
1,770 |
|
|
|
2,168 |
|
|
|
(398 |
) |
|
|
(18.4 |
%) |
Finance expense |
|
(833 |
) |
|
|
(639 |
) |
|
|
(194 |
) |
|
|
30.4 |
% |
Fair value adjustment on warrant liabilities |
|
(12,294 |
) |
|
|
(15,531 |
) |
|
|
3,237 |
|
|
|
(20.8 |
%) |
Foreign currency exchange gain (loss) |
|
(6,114 |
) |
|
|
1,269 |
|
|
|
(7,383 |
) |
|
|
(581.8 |
%) |
Finance result |
|
(17,471 |
) |
|
|
(12,733 |
) |
|
|
(4,738 |
) |
|
|
(37.2 |
%) |
Loss before tax for the period |
|
(99,143 |
) |
|
|
(85,937 |
) |
|
|
(13,206 |
) |
|
|
(15.4 |
%) |
Income tax benefit (expense) |
|
186 |
|
|
|
160 |
|
|
|
26 |
|
|
|
(16.3 |
%) |
Loss for the period |
|
(98,957 |
) |
|
|
(85,777 |
) |
|
|
(13,180 |
) |
|
|
(15.4 |
%) |
Comparison of the Years Ended December 31, 2025 and 2024
Grant Income
Grant income for the years ended December 31, 2025 and 2024 were CHF 1.2 million and CHF 0.7 million, respectively. The grant income is dependent upon the Icelandic government making such reimbursement available for qualified research and development activities. While certain of our research and development expenses have historically qualified for reimbursement and we anticipate incurring a similar level of costs in the future, there is no assurance that the Icelandic government will continue with the tax reimbursement program.
Research and Development Expenses
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
Personnel expenses |
|
18,849 |
|
|
|
11,114 |
|
|
|
7,735 |
|
|
|
69.6 |
% |
Payroll and related expenses |
|
9,851 |
|
|
|
6,085 |
|
|
|
3,766 |
|
|
|
61.9 |
% |
Share-based compensation |
|
8,998 |
|
|
|
5,029 |
|
|
|
3,969 |
|
|
|
78.9 |
% |
Other operating expenses |
|
38,236 |
|
|
|
40,969 |
|
|
|
(2,733 |
) |
|
|
(6.7 |
%) |
External service providers |
|
36,818 |
|
|
|
40,127 |
|
|
|
(3,309 |
) |
|
|
(8.2 |
%) |
Other operating expenses |
|
1,077 |
|
|
|
573 |
|
|
|
504 |
|
|
|
88.0 |
% |
Depreciation expense |
|
341 |
|
|
|
269 |
|
|
|
72 |
|
|
|
26.8 |
% |
Total research and development expenses |
|
57,085 |
|
|
|
52,083 |
|
|
|
5,002 |
|
|
|
9.6 |
% |
Research and development expenses were CHF 57.1 million for the year ended December 31, 2025 compared to CHF 52.1 million for the year ended December 31, 2024. The net increase of CHF 5.0 million, or 9.6%, was primarily due to advancements in our late-stage development portfolio, including Privosegtor development activities and the DIAMOND clinical program. The cost increases were partially offset by a decline in Licaminlimab development costs due to the completion of RELIEF Phase 2 trial in 2024 and commencement of PREDICT registrational trial in late 2025.
The table below represents the breakdown of research and development expenses by project:
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
OCS-01 |
|
35,497 |
|
|
|
32,400 |
|
|
|
3,097 |
|
|
|
9.6 |
% |
Licaminlimab |
|
7,666 |
|
|
|
11,931 |
|
|
|
(4,265 |
) |
|
|
(35.7 |
%) |
Privosegtor |
|
10,938 |
|
|
|
4,266 |
|
|
|
6,672 |
|
|
|
156.4 |
% |
Other development projects |
|
2,984 |
|
|
|
3,486 |
|
|
|
(502 |
) |
|
|
(14.4 |
%) |
Total research and development expenses |
|
57,085 |
|
|
|
52,083 |
|
|
|
5,002 |
|
|
|
9.6 |
% |
50
For the year ended December 31, 2025, research and development expenses were driven by increased development costs related to the advancement of Privosegtor, as well as the OCS-01 Phase 3 DIAMOND-1 and DIAMOND-2 clinical trials in DME which completed enrollment in April 2025 and for which we expect topline results in Q2 2026.
General and Administrative Expenses
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
Personnel expenses |
|
14,997 |
|
|
|
11,476 |
|
|
|
3,521 |
|
|
|
30.7 |
% |
Payroll and related expenses |
|
7,951 |
|
|
|
6,723 |
|
|
|
1,228 |
|
|
|
18.3 |
% |
Share-based compensation |
|
7,046 |
|
|
|
4,753 |
|
|
|
2,293 |
|
|
|
48.2 |
% |
Other operating expenses |
|
10,789 |
|
|
|
10,331 |
|
|
|
458 |
|
|
|
4.4 |
% |
External service providers |
|
8,200 |
|
|
|
7,445 |
|
|
|
755 |
|
|
|
10.1 |
% |
Other operating expenses |
|
2,384 |
|
|
|
2,749 |
|
|
|
(365 |
) |
|
|
(13.3 |
%) |
Depreciation expense |
|
205 |
|
|
|
137 |
|
|
|
68 |
|
|
|
49.6 |
% |
Total general and administrative expenses |
|
25,786 |
|
|
|
21,807 |
|
|
|
3,979 |
|
|
|
18.2 |
% |
General and administrative expenses were CHF 25.8 million for the year ended December 31, 2025, compared to CHF 21.8 million for the year ended December 31, 2024. The increase of CHF 4.0 million, or 18.2%, was primarily driven by an increase in share-based compensation expense due to new equity grants and increased grant value for equity awards granted in 2025.
Finance Income and Finance Expense
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
Finance income |
|
1,770 |
|
|
|
2,168 |
|
|
|
(398 |
) |
|
|
(18.4 |
%) |
Finance expense |
|
(833 |
) |
|
|
(639 |
) |
|
|
(194 |
) |
|
|
30.4 |
% |
Total finance income |
|
937 |
|
|
|
1,529 |
|
|
|
(592 |
) |
|
|
(38.7 |
%) |
We realized net finance income of CHF 0.9 million for the year ended December 31, 2025 compared to CHF 1.5 million for the year ended December 31, 2024. Finance income decreased CHF 0.4 million due to lower interest income from our short-term bank deposits in 2025 compared to 2024. Finance expense increased CHF 0.2 million due to the amortization of transaction costs related to the July 2025 Amended Loan Agreement.
Fair Value Adjustment on Warrant Liabilities
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
Fair value adjustment on warrant liabilities |
|
(12,294 |
) |
|
|
(15,531 |
) |
|
|
3,237 |
|
|
|
(20.8 |
)% |
We recorded fair value adjustment losses on warrant liabilities of CHF 12.3 million and CHF 15.5 million, respectively, for the years ended December 31, 2025 and 2024, primarily due to increases in the market price of the BCA Warrants during the periods.
Foreign Currency Exchange Gain (Loss)
|
For the years ended December 31, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% Change |
|
||||
Foreign currency exchange gain (loss) |
|
(6,114 |
) |
|
|
1,269 |
|
|
|
(7,383 |
) |
|
|
(581.8 |
%) |
We recorded a foreign currency exchange loss of CHF 6.1 million for the year ended December 31, 2025, compared to a gain of CHF 1.3 million for the year ended December 31, 2024. The foreign currency exchange activity reflects fluctuations of the U.S. dollar against the Swiss Franc impacting our cash and short-term financial assets balances, which were net unfavorable in 2025 and favorable in 2024.
51
Comparison of Years Ended December 31, 2024 and 2023
For a discussion of the financial results and condition for the fiscal year ended December 31, 2023, please refer to our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 19, 2024. For a comparison of years ended December 31, 2024 and 2023 please refer to our Annual Report on Form 20-F for the year ended December 31, 2024 filed on March 11, 2025.
B. Liquidity and Capital Resources
Overview
Since our inception, we have incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of products in the near future. We incurred a loss of CHF 99.0 million and a cash outflow from operations of CHF 66.3 million for the year ended December 31, 2025. As of December 31, 2025 and 2024, we had cash, cash equivalents and short-term investments of CHF 213.0 million and CHF 98.7 million, respectively. We had accumulated losses of CHF 384.5 million and CHF 285.6 million as of December 31, 2025 and 2024, respectively.
On April 22, 2024, we closed a registered direct offering with gross proceeds of CHF 53.5 million or $58.8 million through the issuance of 5,000,000 ordinary shares, nominal value CHF 0.01 per share, at a purchase price of CHF 10.70 or $11.75 per share, and commenced trading of our ordinary shares on the Nasdaq Iceland Main Market under the ticker symbol “OCS” on April 23, 2024.
On May 8, 2024, we entered into a sales agreement with Leerink Partners with respect to an ATM Offering Program under which we may offer and sell, from time to time at our sole discretion, ordinary shares having an aggregate offering price of up to $100.0 million (CHF 79.3 million) through Leerink Partners as our sales agent. On October 29, 2025, in conjunction with the November 2025 Underwritten Offering, the Company suspended and terminated the ATM Offering Program. As of the date hereof, we have not sold any ordinary shares under the ATM Offering Program. We will not make any sales of our ordinary shares pursuant to the sales agreement unless and until a new prospectus, prospectus supplement or registration statement is filed. Other than the termination of the ATM Offering Program, the sales agreement remains in full force and effect.
On February 18, 2025, we closed an underwritten offering for the issuance and sale of 5,000,000 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.00 or CHF 18.05 per share, for total gross proceeds of CHF 90.2 million or $100.0 million.
On July 31, 2025, we amended our existing loan facility with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by BlackRock, Inc. (the “Amended Loan Agreement”). The Amended Loan Agreement is structured to provide the EUR equivalent of up to CHF 75.0 million in borrowing capacity (which may be increased to up to CHF 100.0 million), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 25.0 million each, as well as an additional loan of the EUR equivalent of up to CHF 25.0 million, which may be made available by the Lender to us if mutually agreed in writing between us and the Lender.
On November 3, 2025, we closed concurrent underwritten and registered direct offerings of an aggregate of 5,432,098 ordinary shares, CHF 0.01 nominal value per share, at a price per share of $20.25 (CHF 16.33) for total gross proceeds of $110.0 million (CHF 88.7 million) before deducting underwriting discounts and commissions and offering expenses.
We expect to incur additional operating losses in the near future and our operating expenses will increase as we continue invest in the development of our product candidates through additional research and development activities, including clinical trials. See “Risk Factors—Risks related to development and regulatory approval of our investigational therapies.” We will continue to incur additional costs associated with operating as a public company, including expenses related to legal, accounting, financial reporting and regulatory matters, maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and investor relations.
Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term financial assets will be sufficient to fund our operations and capital expenses through at least the next twelve months from the date that this Annual Report is filed with the SEC without additional capital or drawdown from our loan facility. We have based our estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. We may require additional capital resources due to underestimation of the nature, timing and costs of the efforts that will be necessary to complete the development of our product candidates. We may also need to raise additional funds more quickly if we choose to expand our development activities, our portfolio or if we consider acquisitions or other strategic transactions, including licensing transactions. For more information regarding these risks and factors that could
52
influence our future capital requirements and the timing thereof, please see the section entitled “Risk Factors,” included in Item 3.D. of the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 4, 2026.
Future Funding Requirements
Product development is expensive and involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. We will not generate revenue from product sales unless and until we successfully complete clinical development and are able to obtain regulatory approval for and successfully commercialize the product candidates we are currently developing or that we may develop.
Our product candidates, currently under development or that we may develop, will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization.
If we obtain regulatory approval for one or more of our product candidates, we have the options of seeking strategic partnerships or commercializing such products ourselves. If we decide to pursue direct commercialization, we expect to incur significant expenses to develop our commercialization capabilities to support product sales, medical affairs, market access, and marketing and distribution activities, either alone or in collaboration with others. As a result, we may need substantial additional funding to support our continuing operations and pursue our growth strategy.
Until such time, if ever, when we can generate substantial product revenue, we may finance our operations through a combination of private or public equity offerings, debt financings, collaborations, strategic alliances, marketing, distribution or licensing arrangements or through other sources of funding. Adequate capital may not be available to us when needed or on acceptable terms. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of ordinary shares. Debt financing, such as the Amended Loan Agreement, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in fixed payment obligations. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, grant third parties rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain funds through arrangements with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our shareholders. Please see the section entitled “Risk Factors—Risks related to our business, financial condition, capital requirements, or financial operations” included in Item 3.D. of the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 4, 2026 for additional risks associated with our substantial capital requirements.
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing and clinical development of our product candidates. In addition, we will continue to incur additional costs associated with operating as a dual-listed public company, including significant legal, accounting, investor relations and other expenses. Our expenses will also increase as we:
53
See the section of this Annual Report titled “Risk Factors” for additional risks associated with our substantial capital requirements.
Material Cash Requirements for Known Contractual Obligations and Commitments
We have certain payment obligations under existing license and collaboration agreements. Under these agreements, we are required to pay non-refundable, upfront license fees, predefined development and commercial milestone payments and royalties on net sales of licensed products.
License Agreement with Accure for Privosegtor
Pursuant to a license agreement, dated as of January 29, 2022, by and between us and Accure (the “Accure Agreement”), we obtained an exclusive, worldwide, sublicensable (subject to certain conditions) and transferable (subject to certain conditions) license under certain patents, know-how and inventory of Accure for any and all uses and purposes, including to perform research, development, manufacturing and commercialization activities in any manner and for any purpose. The licensed patents are co-owned by Accure with third parties who have reserved the right to use the licensed patents for education and research purposes pursuant to an inter-institutional agreement.
As of December 31, 2025, we had paid the full contractual non-refundable upfront fee of CHF 3.0 million and reimbursed costs in the amount of CHF 0.5 million. In December 2024, we achieved two milestones under the agreement for the IND approval and positive topline data readout from the ACUITY trial and recorded a liability of CHF 1.1 million ($1.2 million) in connection with those milestones, which was paid in 2025. The next clinical and regulatory milestone under the Accure Agreement will trigger a payment of CHF 2.1 million ($2.6 million) that the Company expects to pay in 2026. As of December 31, 2025, we could be further obligated to pay Accure (a) up to CHF 87.9 million ($110.9 million at the December 31, 2025 exchange rate) in the aggregate upon the achievement of additional future development, regulatory and sales milestones; (b) tiered royalties ranging from a mid-single digit to a low mid-teen percentage on net sales of licensed products; and (c) high teens on sublicensing revenues received any time after 36 months from the agreement effective date, and a higher percentage on sublicensing revenues received prior to such date, in all cases subject to reduction for any amounts that were previously paid or are concurrently or later paid by us to Accure pursuant to our milestone payment obligations and such amounts received from a sublicensee will be deduced from amounts owed to Accure. Our royalty payment obligations are subject to certain reductions and expire on a licensed product-by-licensed product and country-by-country basis upon the later of (i) the expiration of the last valid claim of any licensed patent covering such licensed product in such country; (ii) the expiration of such licensed product’s Orphan Drug status, if any, in such country; or (iii) ten (10) years following the date of first commercial sale of such licensed product in such country (the “Payment Period”).
Under the Accure Agreement, we are obligated to use commercially reasonable efforts to develop and seek regulatory approval for a licensed product in major countries of the territory as defined in the Accure Agreement.
The Accure Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the applicable Payment Period with respect to such licensed product in such country. We may terminate the Accure Agreement in whole or in part at any time upon advance written notice (a) for documented reasonable scientific, regulatory, commercial reasons related to the licensed product without incurring any penalty or liability to Accure and (b) for no reason. Each party may terminate the Accure Agreement with immediate effect upon written notice to the other party (i) in the event such other party commits a material breach of its obligations under the Accure Agreement and fails to cure that breach within a specified period of time or (ii) with certain exceptions, upon such other party’s bankruptcy. Accure may terminate the Accure Agreement with immediate effect upon written notice to us if we file any action to invalidate
54
any of the licensed patents or fail to maintain the licensed patents in major countries of the territory as defined in the Accure Agreement, or, subject to certain exceptions, if we fail to meet certain development obligations and are unable to agree upon modifications to the development plan with Accure.
License Agreement with Novartis for Licaminlimab
Pursuant to a license agreement, dated as of December 19, 2018, as amended, by and between us and Novartis (the “Novartis Agreement”), we obtained an exclusive, royalty-bearing, sublicensable (subject to certain conditions), assignable (subject to certain conditions), worldwide license under certain patents, know-how and manufacturing platform technology to develop, manufacture and commercialize pharmaceutical, therapeutic or diagnostic products containing a specified single chain antibody fragment formulation as an active ingredient in the licensed field as defined in the Novartis Agreement. The license granted to us by Novartis includes sublicenses of rights granted to Novartis by certain third parties, and our license to such rights is expressly subject to the applicable terms and conditions of the agreements between Novartis and such third parties.
We originally entered into the Novartis Agreement with Alcon Research, Ltd. (“Alcon”), which subsequently assigned its rights and obligations under the Novartis Agreement to Novartis in connection with its spin-off from Novartis.
We are deemed the owner of any inventions that are (a) created solely by or on behalf of us pursuant to the Novartis Agreement and (b) severable from the licensed products, and grant Novartis a first right to negotiate a worldwide, royalty-bearing license under any patents directed at such inventions for purposes outside of the licensed field. We also grant Novartis a worldwide, non-exclusive, perpetual, irrevocable, royalty-free, fully paid-up license back under any patents owned by us that (i) cover inventions arising from the Novartis Agreement, the practice of which would infringe the patents licensed to us by Novartis, or (ii) otherwise incorporate Novartis’ proprietary information, in each case, for certain uses outside of the licensed field.
We paid in full the contractual non-refundable upfront payment to Alcon of CHF 4.7 million ($4.7 million at the exchange rate at the time of payment) in cash and issued 401,709 ordinary shares (recast subsequent to the BCA) for the residual between the fair value and the upfront payment. This was accounted for as a share-based payment transaction under IFRS 2. As of December 31, 2025, we could be obligated to pay Novartis up to an additional CHF 76.9 million ($97.0 million at the December 31, 2025 exchange rate) in the aggregate upon the achievement of certain development, regulatory, sales and other milestones and tiered royalties ranging from a mid-single digit to a low mid-teen percentage on net sales. In consideration for the exclusive sublicense from Novartis under certain third-party intellectual property rights, we are obligated to pay a low-single digit royalty on our net sales of the licensed product, however, such payments will be deducted from royalties payable to Novartis. Our royalty payment obligations are subject to certain reductions and expire with respect to any licensed product on a country-by-country basis upon the later of (a) the expiration of the last to expire valid claim of any licensed patent covering any such licensed product in such country; (b) the expiration of the period of data exclusivity in any country worldwide; or (c) twelve (12) years after first commercial sale of such licensed product in such country (“Royalty Term”).
Under the Novartis Agreement, we are obligated to use diligent efforts to develop, manufacture or have manufactured, and commercialize the licensed products in the licensed field worldwide. The Novartis Agreement will expire upon the last-to-expire Royalty Term. We may terminate the Novartis Agreement without cause at any time upon advance written notice to Novartis. Upon written notice to Novartis, we may terminate the Novartis Agreement for cause due to the following events: (a) an insolvency event occurs; (b) Novartis materially breaches its obligations under the Novartis Agreement and fails to cure such breach within a specified period of time; or (c) upon advance written notice for material scientific, technical or medical reasons or in case of a material adverse change that renders further continuation of the Novartis Agreement by us commercially unreasonable or otherwise not viable. Upon written notice to us, Novartis may terminate the Novartis Agreement for cause due to the following events: (i) we fail to pay any undisputed amount due under the Novartis Agreement and we fail to remedy such failure within a specified period of time; (ii) an insolvency event occurs; or (iii) we materially breach our obligations under the Novartis Agreement and fail to cure such breach within a specified period of time; or (iv) following negative clinical trial results, we terminate development of the licensed product and do not pursue any further indications in the licensed field.
Other Commitments
The majority of our near term cash needs relate to our clinical and Chemistry, Manufacturing and Controls projects. We have conducted research and development programs through collaborative arrangements that include, among others, arrangements with universities, CROs and clinical research sites. As of December 31, 2025, commitments for external research and development projects totaled CHF 42.0 million, with CHF 31.4 million due within one year and CHF 10.5 million due between one and five years.
55
In addition, we enter into agreements in the normal course of business with CROs for clinical trials and with vendors for preclinical studies, manufacturing services, and other services and products for operating purposes, which are generally cancelable upon written notice.
We have entered into three real estate lease agreements for lab and office facilities. At December 31, 2025, these lease agreements have aggregate lease liabilities of CHF 0.6 million due within one year and CHF 2.4 million due in more than one year.
Refer to Notes 10, 18 and 20 to our audited consolidated financial statements included elsewhere in this Annual Report for further details on our obligations and timing of expected future payments.
Cash Flows
The following table summarizes our sources and uses of cash and cash equivalents for each of the periods presented:
|
For the years ended December 31, |
|
|
|
|
||
|
2025 |
|
2024 |
|
Change |
|
% Change |
Net cash outflow for operating activities |
(66,304) |
|
(48,919) |
|
(17,385) |
|
35.5% |
Net cash outflow for investing activities |
(60,934) |
|
(16,083) |
|
(44,851) |
|
278.9% |
Net cash inflow for financing activities |
186,918 |
|
53,976 |
|
132,942 |
|
246.3% |
Increase (decrease) in cash and cash equivalents |
59,680 |
|
(11,026) |
|
70,706 |
|
(641.3%) |
Total cash, cash equivalents and short-term investments were CHF 213.0 million as of December 31, 2025, which represents an increase of CHF 114.3 million from CHF 98.7 million at December 31, 2024. The increase was primarily due to the February 2025 and November 2025 offerings, partially offset by ongoing operations of the Company.
Operating Activities
For the year ended December 31, 2025, operating activities used CHF 66.3 million of cash, primarily consisting of a loss before tax of CHF 99.1 million, partially offset by non-cash adjustments of CHF 33.0 million and working capital adjustments. Non-cash adjustments primarily consisted of CHF 16.0 million of share-based compensation expense, CHF 12.3 million fair value adjustment loss on warrant liabilities, and CHF 4.0 million of financial result comprised primarily of foreign exchange losses on U.S. dollar liquid asset balances during the period and interest income. Working capital adjustments consisted of a CHF 2.3 million decrease in other current assets, driven by a decrease in prepaid clinical and technical development expenses due to the advancements of clinical trials, primarily the OCS-01 DIAMOND-1 and DIAMOND-2 trials in DME which started in December 2023 and February 2024, respectively, and completed enrollment in April 2025, partially offset by a CHF 1.9 million timing related decrease in payables and accrued liabilities, and a CHF 0.4 million increase in accrued income related to Icelandic government research and development cost reimbursements.
For the year ended December 31, 2024, operating activities used CHF 48.9 million of cash, primarily consisting of a loss before tax of CHF 85.9 million, partially offset by non-cash adjustments of CHF 23.0 million and working capital adjustments of CHF 14.3 million. The decrease in net working capital was driven by an increase of CHF 9.4 million in accrued expenses and other payables, a decrease in other current assets of CHF 5.0 million due to advancements of clinical trials in 2024 that commenced during the fourth quarter of 2023 which resulted in recording of expenses and lowering of prepaid balances and a CHF 0.2 million decrease in accrued income. Non-cash adjustments primarily consisted of CHF 9.8 million of share-based compensation expense, CHF 15.5 million fair value adjustment loss on warrant liabilities, partially offset by CHF 2.7 million of financial result composed of foreign exchange transactions and interest income.
Investing Activities
For the year ended December 31, 2025, investing activities used CHF 60.9 million in cash, primarily driven by CHF 60.8 million for investments in current fixed term bank deposits, net of maturities, as well as a CHF 1.1 million milestone payment to Accure. These outflows were partially offset by CHF 1.2 million of interest received on short term financial assets.
For the year ended December 31, 2024, investing activities used CHF 16.1 million in cash, primarily consisting of CHF 17.3 million for investments in current fixed term bank deposits, net of maturities, partially offset by CHF 1.5 million of interest received on short term financial assets.
56
Financing Activities
For the year ended December 31, 2025, net cash provided by financing activities was CHF 186.9 million, which primarily consisted of CHF 178.9 million of net proceeds received from the issuance and sale of shares in the February 2025 and November 2025 underwritten offerings, CHF 19.8 million received from the exercise of warrants and CHF 1.9 million of proceeds from the exercise of stock options, partially offset by CHF 13.2 million of transaction costs related to financing activities.
For the year ended December 31, 2024, net cash provided by financing activities was CHF 54.0 million, which primarily consisted of proceeds received from the issuance and sale of shares in a registered direct offering.
For a discussion of our cash flows for the year ended December 31, 2023, see Item 5. "Operating and Financial Review and Prospects—B. Liquidity and Capital Resources” in our Annual Report on Form 20-F filed with the SEC on March 11, 2025.
C. Research and Development, Patents and Licenses, etc.
Full details of our research and development activities and expenditures are given in the section titled "Information on the Company—Business Overview” of the section "Business Update" and in the section titled "Operating and Financial Review and Prospects” of this section "Financial Review."
D. Trend Information
Other than as described elsewhere in this Annual Report, we are not aware of any trends, uncertainties, demands, commitments or events that are reasonably likely to have a material adverse effect on our revenue, income from continuing operations, profitability, liquidity or capital resources, or that would cause our reported financial information not necessarily to be indicative of future operating results or financial condition.
E. Critical Accounting Estimates
We prepared our consolidated financial statements in accordance with IFRS Accounting Standards as issued by the IASB. Refer to Note 3 and 4 to our audited consolidated financial statements included elsewhere in this Annual Report for further details on the most significant accounting policies applied in the preparation of our consolidated financial statements and our critical accounting estimates and judgments.
57
Corporate Governance
58
1. Directors, Senior Management and Employees
The following table sets forth the current executive committee members and directors of Oculis as of the filing date. Unless otherwise noted, the business address of each of our directors and executive committee members is Bahnhofstrasse 20, 6300 Zug, Switzerland.
Name |
|
Age |
|
|
Title |
|
Non-Employee Directors |
|
|
|
|
|
|
Anthony Rosenberg |
|
|
73 |
|
|
Chairman of the Board of Directors |
Christina Ackermann |
|
|
61 |
|
|
Director |
Lionel Carnot |
|
|
58 |
|
|
Director |
Arshad M. Khanani |
|
|
47 |
|
|
Director |
Martijn Kleijwegt |
|
|
71 |
|
|
Director |
Geraldine O’Keeffe |
|
|
59 |
|
|
Director |
Robert K. Warner |
|
|
59 |
|
|
Director |
Executive Committee |
|
|
|
|
|
|
Riad Sherif, M.D. |
|
|
58 |
|
|
Chief Executive Officer and Director |
Sylvia Cheung |
|
|
51 |
|
|
Chief Financial Officer |
Páll Ragnar Jóhannesson |
|
|
45 |
|
|
Chief Business Officer |
Non-Employee Directors
Anthony Rosenberg, 73, has served as Chairman of the board of directors of Oculis since April 2018. Since April 2015, Mr. Rosenberg has served as the Chief Executive Officer of TR Advisory Services GmbH. Additionally, from April 2015 to April 2020, Mr. Rosenberg served as a Managing Director of MPM Capital. Prior to that, from 2005 to 2012, Mr. Rosenberg held a series of business development and licensing positions of increasing seniority at Novartis, and most recently, from 2012 to 2015, Mr. Rosenberg served as the Corporate Head of M&A and Licensing at Novartis International AG. Mr. Rosenberg currently serves on the boards of directors of Argenx BV, Cullinan Therapeutics Inc. (previously Cullinan Oncology) and Nuclidium AG. Mr. Rosenberg previously served on the boards of directors of SiO2 Materials Science, TriNetX and Radius Health, Inc. Mr. Rosenberg holds a B.Sc. (Hons) from the University of Leicester and a M.Sc. in Physiology from the University of London.
Christina Ackermann, 61, has served as a member of the board of directors of Oculis since March 2023. Ms. Ackermann serves as the Chair of the board of directors of Virometix, and sits on the Audit Committee and Chairs the Remuneration Committee at Virometix. From January 2022 to May 2023, Ms. Ackermann served as Executive Vice President, General Counsel & President of Ophthalmic Pharmaceuticals at Bausch + Lomb. Ms. Ackermann joined Bausch Health as Executive Vice President, General Counsel, in August 2016. Prior to Bausch Health, Ms. Ackermann was part of the Novartis group of companies for 14 years, most recently serving as Senior Vice President, General Counsel for Alcon, where she was responsible for the legal, intellectual property and compliance functions, in addition to Trade Compliance Function, Enterprise Risk Management and Diversity & Inclusion. Previously, she served as Global Head, Legal and General Counsel at Sandoz, the generics division of Novartis, from 2007 to 2012. She joined Novartis Pharma in 2002 as Head, Legal Technical Operations and Ophthalmics, and assumed the role of Head Legal General Medicine in July 2005. Before Novartis, Ms. Ackermann served in Associate General Counsel roles with Bristol Myers Squibb and DuPont Pharmaceuticals, as well as in private practice, where she focused on securities, and mergers & acquisitions. From August 2021 to March 2023, Ms. Ackermann served on the board of directors of Graybug Vision, where she was Chair of the Nominating and Corporate Governance Committee and a member of the Compensation Committee. Between March 2022 and January 2024, Ms. Ackermann served on the American Glaucoma Society Foundation Advisory Board. From September 2023 to October 2025, Ms. Ackermann served on the board of directors of Verona Pharma, where she was a member of the Commercial Committee and the Audit Committee. Ms. Ackermann holds an LL.B in law from Queen’s University in Ontario, Canada and a post graduate degree in EU competition law from King’s College in London, England.
Lionel Carnot, 58, has served as a member of the board of directors of Oculis since December 2017. Since March 2012, Mr. Carnot has served as Partner of Earlybird Venture Capital. Additionally, from 2005, Mr. Carnot served as a Managing Director of Bay City Capital LLC until 2020. Prior to that, from 2000 to 2005, Mr. Carnot served as an Associate of The Pritzker Organization, LLC. Before that, from 1999 to 2000, Mr. Carnot served as a Principal of Oracle Partners. Prior to that, from 1997 to 1998, Mr. Carnot served as a Senior Associate of Booz Allen and Hamilton. Before that, from 1995 to 1997, Mr. Carnot served as a Product Manager of Eli Lilly & Co. Prior to that, from 1991 to 1994, Mr. Carnot served as a
59
Senior Consultant of Accenture. Before that, from 1989 to 1991, Mr. Carnot served as a sales and marketing professional at Rhone-Poulenc. Mr. Carnot currently serves on the board of directors of Priothera. Mr. Carnot previously served on the board of directors of Atlantic Therapeutics, Merus, Interleukin Genetics, Madrigal Pharmaceuticals Inc., Nabsys, Bioseek, Pathway Diagnostics, Reliant Pharmaceuticals, IQONE Healthcare, and iSTAR Medical. Mr. Carnot holds an MBA with Distinction from INSEAD and a M.Sc. in Molecular Biology from the University of Geneva.
Arshad M. Khanani, M.D., 47, has served as a member of the board of directors of Oculis since May 2024. Dr. Khanani founded the clinical research section at Sierra Eye Associates, and currently serves as its Managing Partner, Director of Clinical Research, and Director of Fellowship. He has been a principal investigator for more than 120 clinical trials and a top enroller in the United States for multiple Phase 1-3 trials. He is also a Clinical Professor at the University of Nevada, Reno School of Medicine and is an elected member of the Retina Society, Macula Society. Dr. Khanani completed his Fellowship in Vitreo-Retinal Diseases and Surgery at the UT Southwestern Medical Center, his Chief Resident in Ophthalmology and his Ophthalmology Residency Program at Texas Tech University Health Sciences Center, where he also received his Doctor of Medicine (M.D.) degree. Dr. Khanani completed an Internship in Internal Medicine at Baylor College and received a Master and Bachelor of Arts (M.A. and B.A.) in Chemistry from Washington University in St. Louis.
Martijn Kleijwegt, 71, has served as a member of the board of directors of Oculis since March 2023. Previously, he served as a member and the Chairman of the EBAC Board from EBAC’s inception in January 2021 to March 2023. Mr. Kleijwegt founded LSP in 1998 and is currently a partner at EQT Life Sciences (f/k/a Life Science Partners). Mr. Kleijwegt has over 30 years of hands-on finance and investment experience. Mr. Kleijwegt currently serves on the boards of Vico Therapeutics International BV, AM-Pharma Holding BV, Avidicure Holding BV, Pantera NV and LSP Advisory BV. Mr. Kleijwegt previously served on the board of directors of OxThera AB and Vicentra BV. Mr. Kleijwegt has a master’s degree in Economics from Amsterdam University.
Geraldine O’Keeffe, 59, has served as a member of the board of directors of Oculis since March 2023. Ms. O’Keeffe joined LSP in 2008. She became a Partner of the firm in 2010. Ms. O’Keeffe’s prime focus and responsibility within LSP is to invest in listed securities. Prior to joining LSP, she held the position of Senior Healthcare Analyst at Fortis Investment Banking. In that position, she researched a wide range of innovative life sciences companies, both in Europe and the US. Before joining the financial community, she worked within the life sciences industry for a number of years, gaining first-hand product development experience in a commercial setting. Prior to working in the industry, she lectured in Biomedical Sciences for several years at the Dublin Institute of Technology. From July 2022 to July 2025, Ms. O’Keeffe served on the board of directors of T-Knife Therapeutics, where she was a member of the Audit Committee. Ms. O’Keeffe has a Bachelor’s degree in Biochemistry and Microbiology from University College Cork and a Master’s degree in Biotechnology from University College Galway. She also conducted post-graduate research, inter alia at the prestigious Max Planck Institute for Biophysical Chemistry in Göttingen, Germany. In addition, Ms. O’Keeffe is also a graduate of The Dublin School of Business.
Robert K. Warner, 59, has served as a member of the board of directors of Oculis since May 2024. Mr. Warner serves on the board of another public company, RXSight, Inc., where he also serves as chair of the nominating and corporate governance committee. In addition, Mr. Warner serves on the board of three private medical device companies, i-Lumen Scientific, where he is also a member of the compensation committee, EyeYon Medical, where he also serves as chairman of the board, and Qlaris Bio. From March 2022 to February 2025, Mr. Warner served on the board of INARI Medical Inc., where he also served as a member of the audit committee. Mr. Warner served as President and General Manager of Alcon Vision Care Franchise Alcon Laboratories from August 2015 until February 2018. Prior to that, Mr. Warner served as President, U.S. and Canada, for Alcon from January 2012 to July 2015 and as President, Canada and Latin America, for Alcon from November 2010 to January 2012. From January 2005 to October 2010, Mr. Warner served in increasing positions of responsibility for Alcon. Mr. Warner was a member of the Alcon Executive Leadership Team for over 10 years and led the Alcon transition from Nestle to Novartis majority ownership. Mr. Warner holds a B.S. in Chemistry from Pace University and an MBA from Rutgers University.
Executive Committee Members
Riad Sherif, M.D., 58, has served as the Chief Executive Officer and member of the board of directors of Oculis since December 2017. Previously, from June 2016 to September 2017, Dr. Sherif served as Entrepreneur in Residence at the Novartis Venture Fund. Before that, Dr. Sherif served as the President of Europe, Middle East and Africa of Alcon, Inc. from March 2014 to May 2016. Prior to that, from January 2002 to April 2014, Dr. Sherif held roles of increasing responsibility at Novartis AG, including as the Global Sales Head in the Transplant and Infectious Disease unit, as the Head for Latin America in transplant and infectious disease, as the President of the Novartis Vaccines and Diagnostics Division for Latin America and where he co-founded Synergium a leading biotech company, and most recently as the President of Novartis Pharmaceuticals, Canada and Novartis Country President. Prior to Novartis, Dr. Sherif worked for
60
several pharmaceutical companies, holding positions of increasing seniority, mainly in marketing and general management with international scope. Dr. Sherif currently serves as a member of the board of directors of Revenio Group Oyi. Dr. Sherif previously served as the Vice Chairman for the Innovative Medicine Canada Association, as the Chairman of In-Vivo Montreal, and as the Chairman of the Board Ophthalmic Surgery and Vision Care of Eucomed. Dr. Sherif is a Medical Doctor by training, and holds an MBA from IMD Business School and a Specialized Master’s Degree in Medical Management from ESCP.
Sylvia Cheung, 51, has served as the Chief Financial Officer of Oculis since September 2020. Prior to that, from October 2005 to August 2020, Ms. Cheung held executive positions at Anika Therapeutics, Inc., a publicly-traded joint preservation company. Most recently, from April 2013 to August 2020, Ms. Cheung served as the Chief Financial Officer of Anika Therapeutics, Inc. Previously, from 2000 to 2005, Ms. Cheung held a series of financial management positions of increasing responsibility at Transkaryotic Therapies, Inc., which was acquired by Shire Pharmaceuticals in 2005. Before that, from 1995 to 2000, Ms. Cheung served as a Senior Associate at PricewaterhouseCoopers. Ms. Cheung holds a Bachelor of Business Administration degree in Accounting from the University of Massachusetts in Amherst, an MBA from Boston University, and was certified as Certified Public Accountant in Massachusetts.
Páll Ragnar Jóhannesson, 45, has served as the Chief Business Officer of Oculis since January 2024. Previously, from September 2020 to January 2024, Mr. Jóhannesson served as the Chief Strategy Officer of Oculis, and from January 2018 to September 2020, Mr. Jóhannesson served as the Chief Financial Officer of Oculis. Additionally, Mr. Jóhannesson has served as the Managing Director of Oculis Iceland ehf. since May 2015. Prior to that, from February 2012 to April 2015, Mr. Jóhannesson held a series of corporate finance positions of increasing responsibility at Straumur Investment Bank, and most recently, from September 2013 to April 2015, Mr. Jóhannesson served as the Managing Director, Corporate Finance. Before that, from January 2009 to November 2011, Mr. Jóhannesson served as a Director, Corporate Finance at Íslandsbanki and its predecessor Glitnir Bank. Mr. Jóhannesson currently serves as a director of Tæknisetur ehf. Mr. Jóhannesson holds a B.Sc. in Industrial Engineering from the University of Iceland, an M.Phil in Management Science from the University of Cambridge, and was certified as securities broker in Iceland.
Family Relationships
There are no family relationships among any of our executive committee members or directors.
Corporate Governance
We structured our corporate governance in a manner we believe closely aligns our interests with those of our shareholders. Notable features of this corporate governance include:
Compensation of Members of the Executive Committee
Historically, our executive compensation program has reflected our innovative growth and development-oriented corporate culture. To date, the compensation of our Chief Executive Officer and our other executive committee members has consisted of a combination of base salary, bonus and long-term equity incentive compensation in the form of restricted stock units (“RSUs”) and/or stock options. Our executive committee members who are full-time employees, like all other full-time employees, are participants in applicable retirement plans in the jurisdiction in which they reside. We evaluate our compensation values and philosophy and compensation plans and arrangements as circumstances merit. We review executive committee compensation periodically with input from a third-party compensation consultant. As part of this review process, the board of directors and the remuneration committee apply our values and philosophy, while considering the compensation levels needed to ensure our executive compensation program remains competitive with our peers. In connection with our executive compensation program, we also review whether we are meeting our retention objectives and the potential cost of replacing a key employee.
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We use base salaries to recognize the experience, skills, knowledge and responsibilities required of all our executive committee members. Base salaries are reviewed annually by the remuneration committee, typically in connection with our annual performance review process, and adjusted from time to time to align salaries with market levels after taking into account individual responsibilities, performance and experience, as well as the results of external benchmarking. In addition, our executive committee members are entitled to annual cash bonuses for their performance over the fiscal year, based on goals established by our board of directors. Furthermore, we have a formal process with respect to the grant of equity incentive awards to our employees, including members of our executive committee. We believe that equity incentive awards provide our employees with a strong link to our long-term performance, create an ownership culture and help to align the interests of our employees, including our executive committee members, and our stockholders. In addition, we believe that equity incentive awards with time-based vesting features promote employee retention because this feature incentivizes our employees, including our executive committee members, to remain in our employment during the vesting period.
Pursuant to Swiss law, we are required to submit the aggregate amount of compensation of our executive officers to a binding say-on-pay vote by our shareholders.
Adoption of Clawback Policy
In October 2023, in accordance with Rule 10D-1 promulgated under the Exchange Act and Nasdaq Listing Rule 5608, we adopted an Incentive Compensation Recoupment Policy which is incorporated by reference herewith at Exhibit 97.1.
Compensation of Directors
Our board of directors adopted a board of directors’ compensation policy that is designed to enable us to attract and retain, on a long-term basis, highly qualified non-employee directors. As of December 31, 2025, we pay each eligible director who is not an employee of the Company annual cash retainers, as set forth below. Lionel Carnot, Martijn Kleijwegt and Geraldine O’Keeffe did not receive any compensation for their services on the Board of Directors during the year ended December 31, 2025 due to policy requirements of their employers which are investors in the Company.
|
|
Annual Cash Retainer |
|
|
Board of Directors Chair |
|
$ |
89,000 |
|
Board of Directors Member |
|
$ |
48,000 |
|
Audit Committee Chair |
|
$ |
20,000 |
|
Audit Committee Member |
|
$ |
12,000 |
|
Remuneration Committee Chair |
|
$ |
15,000 |
|
Remuneration Committee Member |
|
$ |
7,500 |
|
Nomination and Governance Committee Chair |
|
$ |
11,000 |
|
Nomination and Governance Committee Member |
|
$ |
5,500 |
|
In addition, each eligible director elected or appointed to our board of directors is eligible to participate in the Stock Option and Incentive Plan Regulation 2023 of the Company (the “2023 Plan”), subject to its terms and conditions as approved and amended by our board of directors from time to time. Upon joining Oculis, we issue to eligible directors a one-time equity incentive award in the form of RSUs, stock options or similar awards under the 2023 Plan or other equity incentive plans then in effect, at an estimated equity value of $400,000. The exact number of options to be granted and the vesting schedule shall be determined by the Board in the grant notice in its free discretion and only such grant notice shall have legal effect. We will also issue to eligible directors an annual equity incentive award in the form of RSU’s, stock options or similar awards under the 2023 Plan or other equity incentive plans then in effect, at an estimated equity value of $250,000, generally granted on the date of our annual general meeting.
The eligible directors are not eligible to any benefits other than those set out in the directors compensation policy, unless our board of directors decides otherwise. We reimburse all reasonable expenses in accordance with the terms and conditions of our travel and expense policy then in effect.
Pursuant to Swiss law, we are required to submit the aggregate amount of compensation of our board of directors to a binding say-on-pay vote by our shareholders.
Compensation of Directors and Executive Committee Members
For the year ended December 31, 2025, the aggregate compensation earned by the members of our board of directors and our executive committee members for services in all capacities was CHF 14.3 million.
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For the year ended December 31, 2025, fees, salaries and other short-term employee benefits earned by the members of our board of directors and our executive committee members was CHF 2.5 million.
The amount contributed by us to provide post-employment benefits to executive committee members amounted to a total of CHF 0.2 million for the year ended December 31, 2025.
During the year ended December 31, 2025, 293,210 options to purchase ordinary shares and 470,048 RSUs were granted to members of our board of directors and members of our executive committee for a total fair value of CHF 11.5 million.
See Note 13 to our audited consolidated financial statements included elsewhere in this Annual Report for further details regarding the share options, stock appreciation rights and RSUs, including the exercise price and the expiration date.
Risk Oversight
The board of directors is responsible for overseeing our risk management process. The board of directors focuses on our general risk management strategy, the most significant risks, and oversees the implementation of risk mitigation strategies by management, including oversight of cybersecurity risk assessment and risk management. The audit committee is also responsible for discussing our policies with respect to risk assessment and risk management. The board of directors believes its administration of its risk oversight function has not negatively affected the board of directors’ leadership structure.
Code of Business Conduct and Ethics
Our board of directors adopted a Code of Business Conduct and Ethics applicable to the directors, executive committee members and employees that complies with the rules and regulations of the United States Nasdaq Global Market, the Nasdaq Iceland Main Market and the SEC. The Code of Business Conduct and Ethics is available on our website. In addition, we posted on the Corporate Governance section of our website all disclosures that are required by law or United States Nasdaq Global Market listing standards concerning any amendments to, or waivers from, any provision of the Code of Business Conduct and Ethics. The reference to our website address in this Annual Report does not include or incorporate by reference the information on our website into this Annual Report.
Stock Option and Incentive Plan Regulation 2023
The 2023 Plan was approved by our board of directors on March 2, 2023 and amended in May 2024, and provides for the grant of options, restricted stock awards, restricted stock units and stock appreciation rights.
The purpose of the 2023 Plan is to attract and retain highly qualified personnel and to provide key employees, directors and consultants with additional incentive to increase their efforts on behalf of and in the best interest of us and our subsidiaries by giving them the opportunity to acquire a proprietary interest in us. The terms of the 2023 Plan are described in more detail below.
The 2023 Plan shall be administered by a plan administrator (one or several persons) elected by our board of directors from time to time. The plan administrator acts within the guidelines set and approved by our board of directors or a committee thereof and is authorized to, among others, determine (i) which eligible persons are to receive awards under the 2023 Plan, (ii) the time or times when such award grants are to be made, (iii) the nature of the shares and the number of awards covered by each such grant, (iv) the time or times at which each option or stock appreciation right is to become exercisable, (v) the vesting conditions applicable to the awards, (vi) the maximum term for which the options or rights are to remain outstanding, and (vii) any terms and conditions of any restricted stock award, in each case, subject to the guidelines set and approved by our board of directors or a committee thereof. Persons eligible to participate in our 2023 Plan are employees, members of the board of directors and consultants of Oculis or a subsidiary.
The 2023 Plan provides for up to 12,480,000 registered shares to be reserved and available for grant or issuance. In the event registered shares that otherwise would have been issuable under the 2023 Plan are withheld by us in payment of the exercise price or withholding obligations, such shares shall remain available for issuance under the 2023 Plan. In the event that an outstanding award expires or is cancelled, forfeited or terminated for any reason, the shares allocable to the unexercised or unsettled portion shall remain available for issuance under the 2023 Plan.
A participant may only exercise an option or stock appreciation right to the extent that the option or stock appreciation right has vested and has not lapsed under the 2023 Plan. Unless otherwise determined by our board of directors at the grant date or as set forth in the grant notice, an option or an award in the form of a restricted stock unit or stock appreciation right granted under the 2023 Plan typically vests as to 25% of the award at the end of the first year following the vesting start date, with the remaining 75% of the award vesting either monthly or quarterly over the 3 years after the first year following the vesting start date, depending on award type. Any restricted stock may not be transferred or pledged. Such
63
restriction expires with vesting or with the expiration of any repurchase right for the restricted stock. The 2023 Plan provides provisions that govern the exercise of any awards held by the participant at the time the legal relationship forming the basis of the service is coming to an end. Generally, any award not vested shall immediately lapse at the time a notice of termination has been received (regardless of which party gives notice) or at the end of the term in case of a board member. If indicated in the grant notice or otherwise resolved by the board of directors, upon the occurrence of a “Corporate Transaction” (as defined in the 2023 Plan ), all options and awards in the form of restricted stock units or stock appreciation rights (i) shall fully vest and (ii) in the case of options and stock appreciation rights must be immediately exercised, except if such options or stock appreciation rights are repurchased by Oculis or a third party designated by Oculis for a cash consideration equivalent to the economic value applicable to such option or stock appreciation right under the 2023 Plan.
Our board of directors has complete and exclusive power and authority to amend or modify the 2023 Plan in any or all respects. Such amendment or modification shall be communicated in appropriate form as an amendment of the 2023 Plan. Unless such change is required to comply with applicable law, listing requirements, accounting rules or tax requirements, no such amendment or modification shall, without the consent of the concerned participant, adversely affect materially his/her rights and obligations under the 2023 Plan.
Composition of Our Board of Directors
Our board of directors is currently composed of eight members. In accordance with our articles of association, the board of directors is not divided into classes of directors. The directors were appointed until the end of the general meeting of shareholders called to approve our annual accounts for the 2025 financial year.
Seven of eight directors are independent as defined in United States Nasdaq Global Market listing standards and applicable SEC rules and our board of directors has an independent audit committee, a nomination and governance committee, and a remuneration committee.
Committees of our Board of Directors
Our board of directors has three standing committees: an audit committee, a remuneration committee, and a nomination and governance committee. The board has adopted written charters that are available to shareholders on our website at https://investors.oculis.com/corporate-governance. The reference to our website address in this Annual Report on Form 20-F does not include or incorporate by reference the information on our website into this Annual Report on Form 20-F.
Audit Committee
The audit committee consists of Lionel Carnot, Geraldine O’Keeffe and Christina Ackermann. The audit committee assists the board of directors in overseeing our accounting and financial reporting processes and the audits of our financial statements. Mr. Carnot serves as chairperson of the audit committee. In addition, the audit committee is responsible for the appointment, compensation, retention and oversight of the work of our independent registered public accounting firm. Our board of directors has determined that Mr. Carnot, Ms. O’Keeffe and Ms. Ackermann satisfy the “independence” requirements set forth in Rule 10A-3 under the Exchange Act and Mr. Carnot qualifies as an “audit committee financial expert,” as such term is defined in the rules of the SEC.
Each of the members of our audit committee qualify as independent directors according to the rules and regulations of the SEC and United States Nasdaq Global Market with respect to audit committee membership. In addition, all of the audit committee members meet the requirements for financial literacy under applicable SEC and Nasdaq Global Market rules and at least one of the audit committee members qualifies as an “audit committee financial expert,” as such term is defined in Item 407(d) of Regulation S-K. The audit committee is governed by a charter that complies with applicable Nasdaq rules, which charter is posted on our website. We have adopted an audit committee charter, which details the principal functions of the audit committee, including:
64
Remuneration Committee
The remuneration committee consists of Christina Ackermann, Robert K. Warner and Lionel Carnot. The remuneration committee assists the board of directors in determining compensation for members of our executive committee and other key leaders of the Company, and our directors. Ms. Ackermann serves as chairperson of the remuneration committee.
65
We are subject to the Swiss provisions regarding compensations for listed companies under the Swiss Code of Obligations, which require Swiss corporations listed on a stock exchange to establish a remuneration committee. In accordance with the Swiss Code of Obligations, the members of our remuneration committee must be elected during our general meeting of shareholders and the aggregate amount of compensation of each of our directors and our executive committee members must also be approved during a general meeting of shareholders. On June 4, 2025 a general meeting was held during which the shareholders approved the compensation packages for the Board and the executive committee until the next general meeting of shareholders to be held in 2026. At the same meeting, shareholders reelected Ms. Ackermann as the chair of the remuneration committee until the next annual general meeting of shareholders.
Each of the members of our remuneration committee qualifies as an independent director according to the rules and regulations of the SEC and Nasdaq with respect to remuneration committee membership, including the heightened independence standards for members of a remuneration committee. The remuneration committee is governed by a charter that is posted on our website. We have adopted a remuneration committee charter, which details the principal functions of the remuneration committee, including:
66
Nomination and Governance Committee
The nomination and governance committee consists of Robert K. Warner, Geraldine O’Keeffe and Martijn Kleijwegt. The nomination and governance committee assists our board of directors in identifying individuals qualified to become our directors consistent with criteria established by us and in developing our code of business conduct and ethics. Mr. Warner serves as chairperson of the nomination and governance committee. The nomination and governance committee is governed by a charter that is posted on our website. We have adopted a nomination and governance committee charter, which details the principal functions of the nomination and governance committee, including:
67
As of December 31, 2025, we had 60 employees. Our headcount for R&D was 32, and our headcount for G&A was 28. Our employees include 30 executive leadership, administrative, and development personnel based in Switzerland; 10 executive leadership, administrative, and research personnel based in Iceland; 17 executive leadership, administrative, and development personnel based in the United States; and 3 research and development personnel based in France and UK. Pursuant to local laws, our employees in Iceland and France are represented by a labor union or covered under a collective bargaining agreement. We consider our relationship with our employees to be good.
Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants. The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.
For information regarding the share ownership of our directors and executive committee members, see Item 2.A. "Major Shareholders” of this section "Corporate Governance" and Item 1.B. "Compensation” of this section "Corporate Governance" for a discussion of the 2023 Plan.
Not applicable.
2. Major Shareholders and Related Party Transactions
The following table sets forth information regarding the beneficial ownership of our ordinary shares as of December 31, 2025:
Except as otherwise noted herein, the number and percentage of ordinary shares beneficially owned is determined in accordance with Rule 13d-3 of the Exchange Act, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rule, beneficial ownership includes any ordinary shares as to which the holder has sole or shared voting power or investment power and also any ordinary shares which the holder has the right to acquire within 60 days of December 31, 2025 through the exercise or vesting of any option, RSU, warrant or any other right.
We have based percentage ownership on 57,984,438 ordinary shares outstanding as of December 31, 2025.
68
Name and Address of Beneficial Owners |
|
Number of Shares |
|
|
% Ownership |
|
||
Directors and Executive Committee Members (1) |
|
|
|
|
|
|
||
Anthony Rosenberg(2) |
|
|
168,940 |
|
|
* |
|
|
Christina Ackermann(3) |
|
|
62,817 |
|
|
* |
|
|
Lionel Carnot |
|
|
90,753 |
|
|
* |
|
|
Arshad M. Khanani(4) |
|
|
48,528 |
|
|
* |
|
|
Martijn Kleijwegt |
|
|
470,969 |
|
|
* |
|
|
Geraldine O'Keeffe |
|
|
20,593 |
|
|
* |
|
|
Robert K. Warner(5) |
|
|
23,470 |
|
|
* |
|
|
Riad Sherif(6) |
|
|
1,699,553 |
|
|
|
2.9 |
% |
Sylvia Cheung(7) |
|
|
515,022 |
|
|
* |
|
|
Páll Ragnar Jóhannesson(8) |
|
|
772,581 |
|
|
|
1.3 |
% |
All directors and executive committee members |
|
|
3,873,226 |
|
|
|
6.7 |
% |
Five Percent Holders of the Company |
|
|
|
|
|
|
||
LSP 7 Coöperatief U.A.(9) |
|
|
5,900,294 |
|
|
|
10.2 |
% |
Funds managed by Pivotal Partners(10) |
|
|
2,909,995 |
|
|
|
5.0 |
% |
* Indicates beneficial ownership of less than 1.0% of the total ordinary shares outstanding.
69
Significant Changes in Percentage Ownership
In March 2023, we experienced significant changes in the percentage ownership held by major shareholders as a result of the Business Combination.
Voting Rights
The voting rights of the principal shareholders do not differ from the voting rights of other shareholders.
Shareholders in the United States
As of January 22, 2026, to the best of our knowledge 50,982,447 of our outstanding ordinary shares, including earnout shares, were held by 15 shareholders of record in the United States. The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares are held in street name by brokers and other nominees. This number of holders of record also does not include holders whose shares may be held in trust by other entities.
Policies and Procedures for Related Person Transactions
Our board of directors has adopted a written related person transaction policy that sets forth certain policies and procedures for the review and approval or ratification of transactions involving us in which a related person has or will have a direct or indirect material interest, as determined by the audit committee of the Board. A “related person” for purposes of the policy means: (i) enterprises that directly or indirectly through one or more intermediaries, control or are controlled by, or are under common control with, us; (ii) associates (defined as, unconsolidated enterprises in which we have a Significant Influence or which has Significant Influence over us); (iii) individuals owning, directly or indirectly, an interest in the voting power of us that gives them Significant Influence over us, and close members of any such individual’s family; (iv) key management personnel (i.e., having authority and responsibility for planning, directing and controlling our activities), including directors and close members of such individuals’ families; and (v) enterprises in which a substantial interest in the voting power is owned, directly or indirectly, by any person described in (iii) or (iv) above or over which such a person is able to exercise Significant Influence, including enterprises owned by our directors or major shareholders and enterprises that have a member of key management in common with us. “Significant Influence” for purposes of the policy means the power to participate in the financial and operating policy decisions of an enterprise but is less than control over those policies, provided that shareholders beneficially owning a 10.0% or more interest in the voting power of the enterprise concerned are presumed to have a significant influence on such enterprise.
Pursuant to the policy, each director, nominee for director, and executive committee member shall promptly notify the designated contact of any transaction involving us and a related person. The designated contact will present any new related person transactions, and proposed transactions involving related persons, to the audit committee of the board of directors at its next occurring regular meeting. If the audit committee determines that the related person involved has a direct or indirect material interest in the transaction, and therefore that the transaction is a related party transaction, the audit committee shall consider all relevant facts and circumstances, including the commercial reasonableness of the terms, the benefit and perceived benefit, or lack thereof, to Oculis, opportunity costs of alternate transactions, the materiality and character of the related person’s direct or indirect interest, and the actual or apparent conflict of interest of the related person. The audit committee will not approve or ratify a related person transaction unless it shall have determined that, upon consideration of all relevant information, the transaction is in, or not inconsistent with, our best interests. On an annual basis, the audit committee shall review previously approved related person transactions, under the standard described
70
above, to determine whether such transactions should continue. If after the review described above, the audit committee determines not to approve or ratify a related person transaction (whether such transaction is being reviewed for the first time or has previously been approved and is being reviewed), the transaction will not be entered into or continued.
Agreements with members of our Executive Committee and Directors
Aside from standard employment agreements and a consulting agreement with one director, there are no transactions between the Company and its directors and executive committee members. The remuneration of the directors and executive committee members, who are the key management personnel, is described in the section entitled “Compensation.”
Indemnification Agreements
The articles of association provide that we will indemnify our directors and officers to the fullest extent permitted by Swiss law, subject to certain exceptions contained in our articles of association.
In connection with the Business Combination, we also entered into indemnification agreements with each of our directors and executive committee members. The indemnification agreements provide the indemnities with contractual rights to indemnification, and expense advancement and reimbursement, to the fullest extent permitted under Swiss law, subject to certain exceptions contained in those agreements.
Not applicable.
3. Financial Information
A. Consolidated Statements and Other Financial Information
Our consolidated financial statements are appended in this Annual Report, starting at page 79.
Legal Proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
B. Significant Changes
Not applicable.
71
Report of the Statutory Auditor to the General Meeting on the Consolidated Financial Statements 2025
72
Our audit approach
|
|
Overview Overall group materiality: CHF 4,900 thousand The entities addressed by our full scope audit work as well as specific scope audit contribute to more than 9o% of the Group’s total operating expenses. As key audit matter the following area of focus has been identified: Research and development expenses and accruals related to product development related expenses
|
|
Materiality
The scope of our audit was influenced by our application of materiality. Our audit opinion aims to provide reasonable assurance that the consolidated financial statements are free from material misstatement. Misstatements may arise due to fraud or error. They are considered material if, individually or in aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the consolidated financial statements.
Based on our professional judgement, we determined certain quantitative thresholds for materiality, including the overall Group materiality for the consolidated financial statements as a whole as set out in the table below. These, together with qualitative considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit procedures and to evaluate the effect of misstatements, both individually and in aggregate, on the consolidated financial statements as a whole.
|
|
Overall group materiality |
CHF 4,900 thousand |
|
|
Benchmark applied |
Loss before tax |
|
|
Rationale for the materiality benchmark applied |
We chose loss before tax as the benchmark, to be aligned with the common practice in the U.S. for clinical stage life science companies. In addition, in our view, the applied benchmark is aligned with investors and Audit Committee expectations. |
|
|
We agreed with the Audit Committee that we would report to them misstatements above CHF 490 thousand identified during our audit as well as any misstatements below that amount which, in our view, warranted reporting for qualitative reasons.
74
Audit scope
We designed our audit by determining materiality and assessing the risks of material misstatement in the consolidated financial statements. In particular, we considered where subjective judgements were made; for example, in respect of significant accounting estimates that involved making assumptions and considering future events that are inherently uncertain. As in all of our audits, we also addressed the risk of management override of internal controls, including among other matters consideration of whether there was evidence of bias that represented a risk of material misstatement due to fraud.
We tailored the scope of our audit in order to perform sufficient work to enable us to provide an opinion on the consolidated financial statements as a whole, taking into account the structure of the Group, the accounting processes and controls, and the industry in which the Group operates.
Key audit matters
Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the consolidated financial statements of the current period. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.
Research and development expenses and accruals related to product development related expenses
|
|
Key audit matter |
How our audit addressed the key audit matter |
|
|
As described in Notes 3(M), 7.(B) and 16 to the consolidated financial statements, research expenditures are recognized in expense in the year in which they are incurred. Research and development expenses consist mainly of personnel expenses (payroll and related expenses and share-based compensation expense), external service providers and other operating expenses. Research and development expenses for the year ended December 31, 2025 were CHF 57.1 million, the majority of which related to external service providers. As disclosed by management, the Company conducts product research and development programs through third party vendors that include contract research organizations “CROs” and clinical research sites. The Company records accruals for estimated costs incurred or prepayments depending on the stage of completion of the product development and clinical research. Within accrued expenses, total accrued product development related expenses as of December 31, 2025 amounted to CHF 13.2 million. The principal considerations for our determination that performing procedures relating to research and development expenses and accruals related to product development related expenses is a key audit matter are a high degree of auditor effort in performing procedures and evaluating audit evidence related to |
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the research and development expenses process. These procedures also included, among others, (i) testing accuracy and completeness of the report prepared by management to calculate the clinical accruals by obtaining and inspecting source documents, such as contracts, purchase orders and invoices, (ii) testing, on a sample basis, the completeness and accuracy of costs incurred for services that have been performed and for which the Company has been invoiced by comparing amounts to CRO contracts and invoices, and (iii) testing, on a sample basis, classification of research and development expenses.
|
75
the Company’s research and development expenses and accruals. |
|
|
|
Other information
The Board of Directors is responsible for the other information. The other information comprises the information included in the annual report, which has partially been made available to us with the 6-K and 20-F filings, (but does not include the financial statements and the consolidated financial statements and our auditor’s reports thereon), which we obtained prior to the date of this auditor’s report, and the full annual report, which is expected to be made available to us after that date.
Our opinion on the consolidated financial statements does not cover the other information and we do not express any form of assurance conclusion thereon.
In connection with our audit of the consolidated financial statements, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the consolidated financial statements or our knowledge obtained in the audit or otherwise appears to be materially misstated.
If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.
Board of Directors’ responsibilities for the consolidated financial statements
The Board of Directors is responsible for the preparation of consolidated financial statements, that give a true and fair view in accordance with IFRS Accounting Standards and the provisions of Swiss law, and for such internal control as the Board of Directors determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, the Board of Directors is responsible for assessing the Group’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the Board of Directors either intends to liquidate the Group or to cease operations, or has no realistic alternative but to do so.
Auditor’s responsibilities for the audit of the consolidated financial statements
Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Swiss law, ISA and SA-CH will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements.
As part of an audit in accordance with Swiss law, ISA and SA-CH, we exercise professional judgement and maintain professional scepticism throughout the audit. We also:
76
We communicate with the Board of Directors or its relevant committee regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.
We also provide the Board of Directors or its relevant committee with a statement that we have complied with relevant ethical requirements regarding independence, and communicate with them regarding all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied.
From the matters communicated with the Board of Directors or its relevant committee, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication.
Report on other legal and regulatory requirements
In accordance with article 728a para. 1 item 3 CO and PS-CH 890, we confirm the existence of an internal control system that has been designed, pursuant to the instructions of the Board of Directors, for the preparation of the consolidated financial statements.
We recommend that the consolidated financial statements submitted to you be approved.
77
PricewaterhouseCoopers SA
/s/ Alex Fuhrer |
/s/ Violina Eremciuc |
Licensed audit expert |
|
Auditor in charge |
|
Lausanne, March 4, 2026
78
IFRS Consolidated Financial Statements as of and for the year ended December 31, 2025
79
Oculis Holding AG
Consolidated Financial Statements
80
Table of Contents |
|
|
|
|
|
Consolidated Statements of Financial Position as of December 31, 2025 and 2024 |
82 |
Consolidated Statements of Loss for the years ended December 31, 2025, 2024 and 2023 |
83 |
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2025, 2024 and 2023 |
84 |
Consolidated Statements of Changes in Equity for the years ended December 31, 2025, 2024 and 2023 |
85 |
Consolidated Statements of Cash Flows for the years ended December 31, 2025, 2024 and 2023 |
86 |
Notes to the Consolidated Statements |
87 |
81
Oculis Holding AG
Consolidated Statements of Financial Position
(in CHF thousands)
|
|
|
|
As of December 31, |
|
|
As of December 31, |
|
||
|
|
Note |
|
2025 |
|
|
2024 |
|
||
ASSETS |
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
||
Non-current assets |
|
|
|
|
|
|
|
|
||
Property and equipment |
|
8 |
|
|
534 |
|
|
|
385 |
|
Intangible assets |
|
9 |
|
|
13,292 |
|
|
|
13,292 |
|
Right-of-use assets |
|
10 |
|
|
2,463 |
|
|
|
1,303 |
|
Other non-current assets |
|
|
|
|
785 |
|
|
|
476 |
|
Total non-current assets |
|
|
|
|
17,074 |
|
|
|
15,456 |
|
|
|
|
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
|
|
||
Other current assets |
|
11 |
|
|
4,883 |
|
|
|
5,605 |
|
Accrued income |
|
11 |
|
|
993 |
|
|
|
629 |
|
Short-term financial assets |
|
14 |
|
|
131,684 |
|
|
|
70,955 |
|
Cash and cash equivalents |
|
14 |
|
|
81,329 |
|
|
|
27,708 |
|
Total current assets |
|
|
|
|
218,889 |
|
|
|
104,897 |
|
|
|
|
|
|
|
|
|
|
||
TOTAL ASSETS |
|
|
|
|
235,963 |
|
|
|
120,353 |
|
|
|
|
|
|
|
|
|
|
||
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
||
Shareholders’ equity |
|
|
|
|
|
|
|
|
||
Share capital |
|
15 |
|
|
587 |
|
|
|
446 |
|
Share premium |
|
15 |
|
|
551,731 |
|
|
|
344,946 |
|
Reserve for share-based payment |
|
13 |
|
|
30,387 |
|
|
|
16,062 |
|
Actuarial loss on post-employment benefit obligations |
|
12 |
|
|
(1,634 |
) |
|
|
(2,233 |
) |
Treasury shares |
|
15 |
|
|
(7 |
) |
|
|
(10 |
) |
Cumulative translation adjustments |
|
|
|
|
(480 |
) |
|
|
(271 |
) |
Accumulated losses |
|
|
|
|
(384,514 |
) |
|
|
(285,557 |
) |
Total equity |
|
|
|
|
196,070 |
|
|
|
73,383 |
|
|
|
|
|
|
|
|
|
|
||
Non-current liabilities |
|
|
|
|
|
|
|
|
||
Long-term lease liabilities |
|
10 |
|
|
1,811 |
|
|
|
865 |
|
Defined benefit pension liabilities |
|
12 |
|
|
1,335 |
|
|
|
1,870 |
|
Total non-current liabilities |
|
|
|
|
3,146 |
|
|
|
2,735 |
|
|
|
|
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
|
|
||
Trade payables |
|
16 |
|
|
1,800 |
|
|
|
5,871 |
|
Accrued expenses and other payables |
|
16 |
|
|
19,967 |
|
|
|
18,198 |
|
Short-term lease liabilities |
|
10 |
|
|
502 |
|
|
|
315 |
|
Warrant liabilities |
|
17 |
|
|
14,478 |
|
|
|
19,851 |
|
Total current liabilities |
|
|
|
|
36,747 |
|
|
|
44,235 |
|
|
|
|
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
39,893 |
|
|
|
46,970 |
|
|
|
|
|
|
|
|
|
|
||
TOTAL EQUITY AND LIABILITIES |
|
|
|
|
235,963 |
|
|
|
120,353 |
|
The accompanying notes form an integral part of the consolidated financial statements.
82
Oculis Holding AG
Consolidated Statements of Loss
(in CHF thousands, except loss per share data)
|
|
|
|
For the years ended December 31, |
||||||||||
|
|
Note |
|
2025 |
|
|
2024 |
|
2023 |
|
|
|||
Grant income |
|
7. (A) / 11 |
|
|
1,199 |
|
|
|
686 |
|
|
883 |
|
|
Operating income |
|
|
|
|
1,199 |
|
|
|
686 |
|
|
883 |
|
|
Research and development expenses |
|
7. (B) |
|
|
(57,085 |
) |
|
|
(52,083 |
) |
|
(29,247 |
) |
|
General and administrative expenses |
|
7. (B) |
|
|
(25,786 |
) |
|
|
(21,807 |
) |
|
(17,487 |
) |
|
Merger and listing expense |
|
7. (B) |
|
|
- |
|
|
|
- |
|
|
(34,863 |
) |
|
Operating expenses |
|
|
|
|
(82,871 |
) |
|
|
(73,890 |
) |
|
(81,597 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Operating loss |
|
|
|
|
(81,672 |
) |
|
|
(73,204 |
) |
|
(80,714 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Finance income |
|
7. (C) |
|
|
1,770 |
|
|
|
2,168 |
|
|
1,429 |
|
|
Finance expense |
|
7. (C) |
|
|
(833 |
) |
|
|
(639 |
) |
|
(1,315 |
) |
|
Fair value adjustment on warrant liabilities |
|
7. (C) / 17 |
|
|
(12,294 |
) |
|
|
(15,531 |
) |
|
(3,431 |
) |
|
Foreign currency exchange gain (loss) |
|
7. (C) |
|
|
(6,114 |
) |
|
|
1,269 |
|
|
(4,664 |
) |
|
Finance result |
|
|
|
|
(17,471 |
) |
|
|
(12,733 |
) |
|
(7,981 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Loss before tax for the period |
|
|
|
|
(99,143 |
) |
|
|
(85,937 |
) |
|
(88,695 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Income tax benefit (expense) |
|
7. (D) |
|
|
186 |
|
|
|
160 |
|
|
(107 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Loss for the period |
|
|
|
|
(98,957 |
) |
|
|
(85,777 |
) |
|
(88,802 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|||
Basic and diluted loss attributable to equity holders |
|
21 |
|
|
(1.89 |
) |
|
|
(2.12 |
) |
|
(2.97 |
) |
|
The accompanying notes form an integral part of the consolidated financial statements.
83
Oculis Holding AG
Consolidated Statements of Comprehensive Loss
(in CHF thousands)
|
|
|
|
For the years ended December 31, |
|
||||||||
|
Note |
|
|
2025 |
|
|
2024 |
|
2023 |
|
|||
Loss for the period |
|
|
|
|
(98,957 |
) |
|
|
(85,777 |
) |
|
(88,802 |
) |
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|||
Items that will not be reclassified to Statements of Loss: |
|
|
|
|
|
|
|
|
|
|
|||
Actuarial gain (loss) of defined benefit plans |
12 |
|
|
|
599 |
|
|
|
(1,161 |
) |
|
(808 |
) |
Items that may be reclassified subsequently to loss: |
|
|
|
|
|
|
|
|
|
|
|||
Foreign currency translation differences |
2. (D) |
|
|
|
(209 |
) |
|
|
56 |
|
|
(5,005 |
) |
Foreign currency translation differences recycling |
5 |
|
|
|
- |
|
|
|
- |
|
|
4,978 |
|
Other comprehensive income (loss) for the period |
|
|
|
|
390 |
|
|
|
(1,105 |
) |
|
(835 |
) |
|
|
|
|
|
|
|
|
|
|
|
|||
Total comprehensive loss for the period |
|
|
|
|
(98,567 |
) |
|
|
(86,882 |
) |
|
(89,637 |
) |
The accompanying notes form an integral part of the consolidated financial statements.
84
Oculis Holding AG
Consolidated Statements of Changes in Equity
(in CHF thousands, except share numbers)
|
|
Legacy share capital |
|
|
Legacy treasury shares |
|
|
|
Share capital |
|
|
Treasury shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
Note |
Shares |
|
|
Share capital |
|
|
Shares |
|
|
Treasury shares |
|
|
|
Shares |
|
|
Share capital |
|
|
Shares |
|
|
Treasury shares |
|
|
Share premium |
|
|
Reserve for share-based payment |
|
|
Cumulative translation adjustment |
|
|
Actuarial gain (loss) on post-employment benefit obligations |
|
|
Accumulated losses |
|
|
Total |
|
||||||||||||||
Balance as of January 1, 2023 |
|
|
|
3,894,722 |
|
|
|
39 |
|
|
|
(114,323 |
) |
|
|
(1 |
) |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
10,742 |
|
|
|
2,771 |
|
|
|
(300 |
) |
|
|
(264 |
) |
|
|
(110,978 |
) |
|
|
(97,991 |
) |
Loss for the period |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(88,802 |
) |
|
|
(88,802 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Actuarial loss on post-employment benefit obligations |
|
12 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(808 |
) |
|
|
- |
|
|
|
(808 |
) |
Foreign currency translation differences |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,005 |
) |
|
|
- |
|
|
|
- |
|
|
|
(5,005 |
) |
Foreign currency translation differences recycling |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,978 |
|
|
|
- |
|
|
|
- |
|
|
|
4,978 |
|
Total comprehensive loss for the period |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(27 |
) |
|
|
(808 |
) |
|
|
(88,802 |
) |
|
|
(89,637 |
) |
Share-based compensation expense |
|
13 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,608 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,608 |
|
Conversion of Legacy Oculis ordinary shares and treasury shares into Oculis ordinary shares |
|
5 |
|
(3,894,722 |
) |
|
|
(39 |
) |
|
|
114,323 |
|
|
|
1 |
|
|
|
|
3,780,399 |
|
|
|
38 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Conversion of Legacy Oculis long-term financial debt into Oculis ordinary shares |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
16,496,603 |
|
|
|
165 |
|
|
|
- |
|
|
|
- |
|
|
|
124,637 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
124,802 |
|
Issuance of ordinary shares to PIPE investors |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
7,118,891 |
|
|
|
71 |
|
|
|
- |
|
|
|
- |
|
|
|
66,983 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
67,054 |
|
Issuance of ordinary shares under CLA |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
1,967,000 |
|
|
|
20 |
|
|
|
- |
|
|
|
- |
|
|
|
18,348 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
18,368 |
|
Issuance of ordinary shares to EBAC shareholders |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
3,370,480 |
|
|
|
33 |
|
|
|
- |
|
|
|
- |
|
|
|
35,492 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
35,525 |
|
Transaction costs related to the business combination |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,821 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,821 |
) |
Proceeds from sale of shares in public offering |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
3,654,234 |
|
|
|
36 |
|
|
|
- |
|
|
|
- |
|
|
|
38,143 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
38,179 |
|
Transaction costs related to the public offering |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,361 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,361 |
) |
Stock option exercised |
|
13 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
112,942 |
|
|
|
1 |
|
|
|
- |
|
|
|
- |
|
|
|
273 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
274 |
|
Issuance of shares in connection with warrant exercises |
|
17 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
149,156 |
|
|
|
2 |
|
|
|
- |
|
|
|
- |
|
|
|
1,726 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,728 |
|
Balance as of December 31, 2023 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
36,649,705 |
|
|
|
366 |
|
|
|
- |
|
|
|
- |
|
|
|
288,162 |
|
|
|
6,379 |
|
|
|
(327 |
) |
|
|
(1,072 |
) |
|
|
(199,780 |
) |
|
|
93,728 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance as of January 1, 2024 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
36,649,705 |
|
|
|
366 |
|
|
|
- |
|
|
|
- |
|
|
|
288,162 |
|
|
|
6,379 |
|
|
|
(327 |
) |
|
|
(1,072 |
) |
|
|
(199,780 |
) |
|
|
93,728 |
|
Loss for the period |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(85,777 |
) |
|
|
(85,777 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Actuarial loss on post-employment benefit obligations |
|
12 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,161 |
) |
|
|
- |
|
|
|
(1,161 |
) |
Foreign currency translation differences |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
56 |
|
|
|
- |
|
|
|
- |
|
|
|
56 |
|
Total comprehensive loss for the period |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
56 |
|
|
|
(1,161 |
) |
|
|
(85,777 |
) |
|
|
(86,882 |
) |
Share-based compensation expense |
|
13 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
9,782 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
9,782 |
|
Issuance of ordinary shares related to registered direct offering |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
5,000,000 |
|
|
|
50 |
|
|
|
- |
|
|
|
- |
|
|
|
53,491 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
53,541 |
|
Transaction costs related to registered direct offering |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,868 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,868 |
) |
Issuance of shares to be held as treasury shares |
|
15 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
1,000,000 |
|
|
|
10 |
|
|
|
(1,000,000 |
) |
|
|
(10 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Vesting of earnout shares |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
1,422,723 |
|
|
|
14 |
|
|
|
- |
|
|
|
- |
|
|
|
(14 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Warrants exercised |
|
17 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
279,033 |
|
|
|
3 |
|
|
|
- |
|
|
|
- |
|
|
|
4,141 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,144 |
|
Stock options exercised and RSUs vested/released |
|
13 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
310,941 |
|
|
|
3 |
|
|
|
- |
|
|
|
- |
|
|
|
1,034 |
|
|
|
(99 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
938 |
|
Balance as of December 31, 2024 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
44,662,402 |
|
|
|
446 |
|
|
|
(1,000,000 |
) |
|
|
(10 |
) |
|
|
344,946 |
|
|
|
16,062 |
|
|
|
(271 |
) |
|
|
(2,233 |
) |
|
|
(285,557 |
) |
|
|
73,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance as of January 1, 2025 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
44,662,402 |
|
|
|
446 |
|
|
|
(1,000,000 |
) |
|
|
(10 |
) |
|
|
344,946 |
|
|
|
16,062 |
|
|
|
(271 |
) |
|
|
(2,233 |
) |
|
|
(285,557 |
) |
|
|
73,383 |
|
Loss for the period |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(98,957 |
) |
|
|
(98,957 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Actuarial gain on post-employment benefit obligations |
|
12 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
599 |
|
|
|
- |
|
|
|
599 |
|
Foreign currency translation differences |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(209 |
) |
|
|
- |
|
|
|
- |
|
|
|
(209 |
) |
Total comprehensive loss for the period |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(209 |
) |
|
|
599 |
|
|
|
(98,957 |
) |
|
|
(98,567 |
) |
Share-based compensation expense |
|
13 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
16,044 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
16,044 |
|
Issuance of ordinary shares related to underwritten offerings |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
7,635,801 |
|
|
|
76 |
|
|
|
2,796,297 |
|
|
|
28 |
|
|
|
178,755 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
178,859 |
|
Transaction costs related to the issuance of ordinary shares |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(13,335 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(13,335 |
) |
Vesting of earnout shares |
|
5 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
1,422,723 |
|
|
|
14 |
|
|
|
- |
|
|
|
- |
|
|
|
(14 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of shares to be held as treasury shares |
|
15 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
2,500,000 |
|
|
|
25 |
|
|
|
(2,500,000 |
) |
|
|
(25 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Warrants exercised |
|
17 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
1,929,467 |
|
|
|
19 |
|
|
|
- |
|
|
|
- |
|
|
|
37,771 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
37,790 |
|
Stock options exercised and RSUs vested/released |
|
13 |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
537,748 |
|
|
|
7 |
|
|
|
- |
|
|
|
- |
|
|
|
3,608 |
|
|
|
(1,719 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,896 |
|
Balance as of December 31, 2025 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
58,688,141 |
|
|
|
587 |
|
|
|
(703,703 |
) |
|
|
(7 |
) |
|
|
551,731 |
|
|
|
30,387 |
|
|
|
(480 |
) |
|
|
(1,634 |
) |
|
|
(384,514 |
) |
|
|
196,070 |
|
The accompanying notes form an integral part of the consolidated financial statements.
85
Oculis Holding AG
Consolidated Statements of Cash Flows
(in CHF thousands)
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For the years ended December 31, |
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Note |
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2025 |
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2024 |
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2023 |
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Operating activities |
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Loss before tax for the period |
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(99,143 |
) |
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(85,937 |
) |
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(88,695 |
) |
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Non-cash adjustments: |
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- Financial result |
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3,983 |
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(2,674 |
) |
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3,466 |
|
- Depreciation of property and equipment and right-of-use assets |
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|
546 |
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|
|
406 |
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|
287 |
|
- Share-based compensation expense |
|
13 |
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16,044 |
|
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9,782 |
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3,608 |
|
- Interest expense on Series B and C preferred shares |
|
15 / 7.(C) |
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- |
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|
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- |
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1,266 |
|
- Post-employment (benefits)/ loss |
|
12 |
|
|
101 |
|
|
|
(36 |
) |
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(171 |
) |
- Fair value adjustment on warrant liabilities |
|
17 |
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12,294 |
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15,531 |
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3,431 |
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- Merger and listing expense |
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5 |
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- |
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- |
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34,863 |
|
Working capital adjustments: |
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- De/(Increase) in other current assets |
|
11 |
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2,349 |
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4,981 |
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|
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(5,556 |
) |
- De/(Increase) in accrued income |
|
11 |
|
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(364 |
) |
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|
247 |
|
|
|
36 |
|
- De/(Increase) in other operating assets |
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|
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(112 |
) |
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|
(95 |
) |
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(29 |
) |
- (De)/Increase in payables and accrued liabilities |
|
16 |
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(1,947 |
) |
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9,406 |
|
|
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(7,820 |
) |
- (De)/Increase in long-term payables |
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- |
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|
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(378 |
) |
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|
378 |
|
Taxes (paid)/ received |
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|
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(55 |
) |
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(152 |
) |
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|
(101 |
) |
Net cash outflow for operating activities |
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|
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(66,304 |
) |
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(48,919 |
) |
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(55,037 |
) |
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Investing activities |
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Payment for purchase of property and equipment |
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8 |
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(301 |
) |
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(230 |
) |
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(48 |
) |
Interest received |
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|
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1,241 |
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1,474 |
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1,238 |
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Payment for short-term financial assets, net |
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14 |
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(60,787 |
) |
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(17,327 |
) |
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(54,163 |
) |
Payment for intangible assets |
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9 |
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(1,087 |
) |
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- |
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- |
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Net cash outflow for investing activities |
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(60,934 |
) |
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(16,083 |
) |
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(52,973 |
) |
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Financing activities |
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Proceeds from sale of shares in public offerings |
|
5 |
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178,859 |
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53,541 |
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38,179 |
|
Transaction costs related to financing activities |
|
5 |
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(13,222 |
) |
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(2,894 |
) |
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(2,983 |
) |
Proceeds from exercises of warrants, net |
|
17 |
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|
19,845 |
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2,719 |
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1,531 |
|
Proceeds from stock options exercised |
|
13 |
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1,896 |
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|
938 |
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|
274 |
|
Principal payment of lease obligations |
|
10 |
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(373 |
) |
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(274 |
) |
|
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(158 |
) |
Interest paid |
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|
|
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(87 |
) |
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(54 |
) |
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(46 |
) |
Proceeds from the shares issued to PIPE investors |
|
5 |
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- |
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- |
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67,054 |
|
Proceeds from the shares issued to CLA investors |
|
5 |
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- |
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- |
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18,368 |
|
Proceeds from EBAC non-redeemed shareholders |
|
5 |
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- |
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- |
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12,014 |
|
Transaction costs related to the business combination |
|
5 |
|
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- |
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- |
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(4,607 |
) |
Net cash inflow for financing activities |
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186,918 |
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53,976 |
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129,626 |
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Increase (decrease) in cash and cash equivalents |
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59,680 |
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(11,026 |
) |
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21,616 |
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Cash and cash equivalents, beginning of period |
|
14 |
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27,708 |
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38,327 |
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19,786 |
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Effect of foreign exchange rate changes |
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(6,059 |
) |
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|
407 |
|
|
|
(3,075 |
) |
Cash and cash equivalents, end of period |
|
14 |
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81,329 |
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27,708 |
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|
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38,327 |
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Net cash and cash equivalents variation |
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59,680 |
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(11,026 |
) |
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21,616 |
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Supplemental non-cash investing information |
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Intangible assets acquisition recorded in accrued expenses |
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|
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- |
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1,087 |
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- |
|
Interest receivable recorded in other current assets |
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|
593 |
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|
737 |
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|
388 |
|
Supplemental non-cash financing information |
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Transaction costs recorded in accrued expenses and other payables |
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|
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|
878 |
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- |
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|
378 |
|
The accompanying notes form an integral part of the consolidated financial statements.
86
Oculis Holding AG
Notes to the consolidated financial statements
(All amounts presented in CHF thousands, except share numbers, unless otherwise noted)
Oculis Holding AG (“Oculis” or the “Company”) is a stock corporation (“Aktiengesellschaft”) with its registered office at Bahnhofstrasse 20, CH-6300, Zug, Switzerland. It was incorporated under the laws of Switzerland on October 31, 2022.
The Company controls seven wholly-owned subsidiaries: Oculis Operations Sàrl (“Oculis Operations”) with its registered office in Lausanne, Switzerland, which was incorporated in Zug, Switzerland on December 27, 2022, Oculis ehf (“Oculis Iceland”), which was incorporated in Reykjavik, Iceland on October 28, 2003, Oculis France Sàrl (“Oculis France”) which was incorporated in Paris, France on March 27, 2020, Oculis US, Inc. with its registered office in Newton MA, USA, which was incorporated in Delaware, USA, on May 26, 2020, Oculis HK, Limited (“Oculis HK”) which was incorporated in Hong Kong, China on June 1, 2021, Neurocol IP Sàrl (“Neurocol IP”), which was incorporated in Lausanne, Switzerland on December 4, 2025, and Neurocol Operations Sàrl (“Neurocol Operations”), which was incorporated in Lausanne, Switzerland on December 4, 2025. The Company and its wholly-owned subsidiaries form the Oculis Group (the “Group”).
Oculis is a global late clinical-stage biopharmaceutical company with substantial expertise in therapeutics for the treatment of ophthalmic and neuro-ophthalmic diseases. Oculis is engaged in developing innovative drug candidates with the potential to address significant unmet medical needs for many eye-related and neuro-ophthalmic conditions. The Company’s mission is to save sight and improve eye care for patients worldwide and it intends to become a global leader in ophthalmic and neuro-ophthalmic therapeutics to realize this mission.
The consolidated financial statements of Oculis as of and for the year ended December 31, 2025, were approved and authorized for issue by the Company’s Board of Directors on March 4, 2026.
The Group’s accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances, as well as government research and development grants. The November and February 2025 offerings, as well as prior financing transactions raised funding to secure business continuity as explained under Note 5. The Board of Directors believes that the Group has the ability to meet its financial obligations for at least the next 12 months.
The Company is a late clinical stage company and is exposed to all the risks inherent to establishing a business, including the substantial uncertainty as to whether current projects will succeed. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection; (ii) enter into collaborations with partners in the biotech and pharmaceutical industry; (iii) successfully move its product candidates through preclinical and clinical development; (iv) successfully obtain regulatory approval and commercialize its products; and (v) attract and retain key personnel. The Company’s success is subject to its ability to raise capital to support its current and future operations. To date, the Company has financed its cash requirements primarily through the sale of its preferred and ordinary shares and issuance of shares from warrants exercises. The Company will continue to evaluate additional funding through public or private financings, debt financing or collaboration agreements. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to (i) significantly delay, scale back or discontinue the development of one or more of its product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to product candidates that the Company would otherwise seek to develop itself, on unfavorable terms.
The consolidated financial statements of Oculis are prepared in accordance with IFRS Accounting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).
87
The policies set out below are consistently applied to all the years presented. The consolidated financial statements have been prepared under the historical cost convention, unless stated otherwise in the accounting policies in Note 3.
The totals are calculated with the original unit amounts, which could lead to rounding differences. These differences in thousands of units are not changed in order to keep the accuracy of the original data.
The consolidated financial statements of the Group are expressed in Swiss Francs (“CHF”), which is the Company’s functional and the Group’s presentation currency. The functional currency of the Company’s subsidiaries is the local currency except for Oculis Iceland whose functional currency is CHF.
Assets and liabilities of foreign operations are translated into CHF at the rate of exchange prevailing at the reporting date and their statements of profit or loss are translated at average monthly exchange rates. The exchange differences arising on translation for consolidation are recognized in other comprehensive income.
The principal accounting policies adopted in the preparation of these financial statements are set out below. The policies set out below are consistently applied to all the years presented, unless otherwise stated.
The Company presents assets and liabilities on the balance sheet based on current/non-current classification. The Company classifies all amounts to be realized or settled within 12 months after the reporting period to be current and all other amounts to be non-current. Liabilities are classified as non-current if the Company has the unconditional right to defer settlement for at least 12 months after the reporting period.
Foreign currency transactions are translated into the functional currency, CHF, using prevailing exchange rates at the dates of the transactions. Monetary assets and liabilities denominated in foreign currencies are translated into CHF at rates of exchange prevailing at reporting date. Any gains or losses from these translations are included in the statements of loss in the period in which they arise.
The Company has seven wholly owned subsidiaries, including Oculis Operations, Oculis Iceland, Oculis France, Oculis U.S., Oculis HK, Neurocol IP and Neurocol Operations. The Company’s consolidated financial statements present the aggregate of the eight Group entities, after elimination of intra-group transactions, balances, investments and capital.
The Company is managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business and accordingly, has one reporting segment.
The Company has locations in five countries: Switzerland, Iceland, France, U.S. and Hong Kong. An analysis of non-current assets by geographic region is presented in Note 6.
All leases are accounted for by recognizing a right-of-use asset and a lease liability except for leases of low value assets and leases with a duration of 12 months or less.
Lease liabilities are measured at the present value of the expected contractual payments due to the lessor over the lease term, with the discount rate determined by reference to the rate inherent in the lease unless this is not readily determinable, in which case the Group’s incremental borrowing rate on commencement date of the lease is used. Variable lease payments are only included in the measurement of the lease liability if they depend on an index or rate and remain unchanged throughout the lease term. Other variable lease payments are expensed.
88
On initial recognition, the carrying value of the lease liability also includes amounts expected to be payable under any residual value guarantee, and the exercise price of any purchase option granted in favor of the group if it is reasonably certain to assess that option. Right-of-use assets are initially measured at the amount of the lease liability, reduced for any lease incentives received, and increased for lease payments made at or before commencement of the lease and initial direct costs incurred.
Subsequent to the initial measurement, lease liabilities increase as a result of interest charged at a constant rate on the balance outstanding and are reduced for lease payments made. Right-of-use assets are depreciated on a straight-line basis over the remaining expected term of the lease or over the remaining economic life of the asset if this is judged to be shorter than the lease term.
When the Company revises its estimate of the term of any lease, it adjusts the carrying amount of the lease liability to reflect the expected payments over the revised term, which are discounted using a revised discount rate. The carrying value of lease liabilities is similarly revised if the variable future lease payments dependent on a rate or index is revised. In both cases, an equivalent adjustment is made to the carrying value of the right-of-use asset, with the revised carrying amount being amortized over the remaining lease term. If the carrying amount of the right-of-use asset is adjusted to zero, any further reduction is recognized in profit or loss.
Grant income is recognized where there is reasonable assurance that the grant will be received and all attaching conditions will be complied with, and in the year when the related expenses are incurred.
Taxes reported in the consolidated statements of loss include current and deferred taxes on profit. Taxes on income are accrued in the same periods as the revenues and expenses to which they relate.
Deferred tax is the tax attributable to the temporary differences that appear when taxation authorities recognize and measure assets and liabilities with rules that differ from those of the consolidated accounts. Deferred income tax is calculated using the liability method and determined using tax rates and laws that have been enacted or substantively enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realized, or the deferred income tax liability is settled. Any changes to the tax rates are recognized in the consolidated statements of loss unless related to items directly recognized in equity or other comprehensive loss.
Deferred income tax is recognized on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the temporary differences or the unused tax losses can be utilized. Deferred income tax assets from tax credit carry forwards are recognized to the extent that the national tax authority confirms the eligibility of such a claim and that the realization of the related tax benefit through future taxable profits is probable. Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current tax liabilities and when the deferred income tax assets and liabilities relate to income taxes levied by the same taxation authority on either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.
The Company presents basic loss per share for each period in the financial statements. The loss per share is calculated by dividing the loss of the period by the weighted average number of shares outstanding during the period. Diluted earnings per share, applicable in case of positive result, reflect the potential dilution that could occur if dilutive securities such as warrants or share options were exercised into common shares.
The Company considers all highly liquid investments with an original maturity of less than 3 months at the date of purchase to be cash equivalents. Cash and cash equivalents are recorded at cost, which approximates fair value.
89
Short-term financial assets consist of fixed term bank deposits with original maturities between three and six months. Short-term financial assets are held in order to collect contractual cash flows made of payments of principal and interests.
Short-term financial assets are measured at amortized cost, which approximates fair value, and are subsequently measured using the effective interest method. This method allocates interest income over the relevant period by applying the effective interest rate to the carrying amount of the asset. Gains and losses are recognized in the consolidated statements of loss when the asset is derecognized, modified or impaired.
The Company measures certain financial assets and liabilities at fair value on a recurring basis, including warrants. Fair value is the price the Company would receive to sell an asset or pay to transfer a liability in an orderly transaction with a market participant at the measurement date. The Company uses a three-level hierarchy that prioritizes fair value measurements based on the types of inputs used, as follows:
There was no change in the valuation techniques applied to financial instruments during all periods presented. There were no transfers between levels 1, 2 or 3 for recurring fair value measurements during the year. The Group recognizes transfers into and out of fair value hierarchy levels at the end of the reporting period.
All property and equipment are shown at cost, less subsequent depreciation and impairment. Cost includes expenditures that are directly attributable to the acquisition of the items. Subsequent costs are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably.
Depreciation is calculated on a straight-line basis over the useful life, according to the following schedule:
Category |
Useful life in years |
Laboratory equipment |
5 - 7 |
Laboratory fixtures and fittings |
10 |
Office equipment and hardware |
2 - 3 |
Leasehold improvements |
5 |
The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date. An asset’s carrying amount is impaired immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount. Gains and losses on disposal or retirement of tangible fixed assets are determined by comparing the net proceeds received with the carrying amounts and are included in the consolidated statements of loss.
The Company recognizes the warrant instruments as liabilities at fair value and adjusts the instruments to fair value at each reporting period (refer to Note 17). Any change in fair value is recognized in the Company’s consolidated statements of loss. Warrants are classified as short-term liabilities as the Company cannot defer the settlement beyond 12 months.
The Amended BlackRock Warrant, as defined in Note 5, issued in conjunction with the Amended Loan Agreement is classified as a liability since its exercise price is fixed in USD, which is not the functional currency of the Company and therefore it does not meet the requirements to be classified as equity under IFRS. An instrument that will be settled in the Company’s own equity shares is an equity instrument only if the issuer has to deliver a fixed number of its own shares for a fixed amount (fixed for fixed requirement, IAS 32.16). The fair value of the BlackRock Warrant is determined using the Black-Scholes option-pricing model. This valuation model as well as parameters used such as expected volatility and expected term are partially based on management’s estimates. The expected volatility is estimated using historical stock volatilities of comparable peer public companies within the Company’s industry. The expected term represents the period
90
that the warrant is expected to be outstanding. The BlackRock Warrant is included in Level 3 of the fair value hierarchy. Refer to Note 17 - Warrant Liabilities.
The fair value of the BCA Public Warrants, as defined in Note 5, traded in active markets is based on the quoted market prices at the end of the reporting period for such warrants. For the BCA Private Warrants, which have identical terms to the BCA Public Warrants, the Company determined that the fair value of each BCA Private Warrant is equivalent to that of each BCA Public Warrant. BCA Public Warrants are included in Level 1 and BCA Private Warrants in Level 2 of the fair value hierarchy. Refer to Note 17 - Warrant Liabilities.
Research expenditures are recognized in expense in the year in which they are incurred. Internal development expenditures are capitalized only if they meet the recognition criteria of IAS 38 “Intangible Assets.” Given the inherent regulatory and other uncertainties, these criteria are generally not met before obtaining approval from the relevant regulatory authority. As a result, development expenditures are typically recognized as expenses in the consolidated statements of loss. However, when capitalization criteria are satisfied, development costs are recorded as intangible assets and amortized on a straight-line basis over their estimated useful lives. Amortization of capitalized licenses begins upon receipt of market approval. The Company records accruals for estimated costs incurred or prepayments depending on the stage of completion of the product development and clinical research.
Acquired licenses and related development milestones are capitalized as intangible assets at historical cost and amortized over their estimated useful lives. The amortization period is determined based on the expected pattern of consumption of future economic benefits and begins only after the necessary regulatory and marketing approvals have been obtained. Capitalized licenses are assessed for impairment annually in the last quarter of each financial period or earlier if indicators of impairment arise. Amortization expense related to capitalized licenses is recognized within research and development expenses.
Impairment losses on capitalized licenses are recognized within research and development expenses.
Assets that are subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of the asset’s fair value less costs of disposal and value-in-use.
For the purpose of impairment testing, assets are grouped together into the smallest group of assets that generate cash inflows from continuing use that are largely independent of the cash flows of other assets (“cash-generating units”). Impairment losses are recognized in the consolidated statements of loss. Prior impairments of non-financial assets are reviewed for possible reversal of the impairment at each reporting date.
The principal financial instruments used by the Company are as follows:
91
These financial instruments are carried at amortized cost, except warrant liabilities which are adjusted to fair value at period end.
Due to their short-term nature, the carrying value of cash and cash equivalents, short-term financial assets, other current assets, excluding prepaid expenses, accrued income, lease liabilities, trade payables, accrued expenses and other payables approximates their fair value. For details of the fair value hierarchy and valuation techniques, refer to Note 20.
Cash and cash equivalents include cash on hand and highly liquid investments with original maturities of three months or less. These investments are readily convertible to known amounts of cash.
Short-term financial assets consist of fixed term bank deposits with original maturities between three and six months. Short-term financial assets are held in order to collect contractual cash flows made of payments of principal and interests.
The carrying amount of other receivables/current assets is reduced through the use of an allowance account, and the amount of the loss is recognized in the consolidated statements of loss. Subsequent recoveries of amounts previously written off are credited to the consolidated statements of loss.
Grant income reflects reimbursement of research and development expenses and income from certain research projects managed by Icelandic governmental institutions. Certain expenses qualify for incentives from the Icelandic government in the form of tax credits or cash reimbursements.
Trade payables are amounts due to third parties in the ordinary course of business. Trade payables are non-interest bearing and are normally settled on 45-day terms.
Accrued expenses and other payables are amounts provided for / due to third parties in the ordinary course of business. Accrued expenses and other payables are non-interest bearing.
Lease liabilities are measured at the present value of the expected contractual payments due to the lessor over the lease term, with the discount rate determined by reference to the rate inherent in the lease unless this is not readily determinable, in which case the Group’s incremental borrowing rate on commencement date of the lease is used.
The Company operates a defined benefit pension plan for its Swiss-based employees, which is held in a multi-employer fund. The pension plan is funded by payments from employees and from the Company. The Company’s contributions to the defined benefit pension plan are charged to the consolidated statements of loss in the year to which they relate.
The liability recognized in the balance sheet in respect of defined benefit pension plan is the present value of the defined benefit obligation at the balance sheet date less the fair value of plan assets and the possible effect of the asset ceiling, together with adjustments for unrecognized past-service costs. The defined benefit obligation is calculated annually by independent actuaries using the projected unit credit method.
92
When the Company has a surplus in the defined benefit pension plan, it measures the net defined benefit asset at the lower of the surplus in the defined benefit pension plan, or the asset ceiling (being the present value of any economic benefits available in the form of refunds from the plan or reductions in future contributions to the plan), determined using the discount rate.
The Company does not expect any refunds or contribution reductions in case of a surplus in the defined benefit pension plan calculated per IAS 19, therefore no assets would be recognized in the Consolidated Statements of Financial Position.
The present value of the defined benefit obligation is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating to the terms of the related pension liability.
Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are charged or credited to equity in other comprehensive income in the period in which they arise.
Past-service costs are recognized immediately in income, unless the changes to the pension plan are conditional on the employees remaining in service for a specified period of time (the vesting period). In this case, the past-service costs are amortized on a straight-line basis over the vesting period.
The Company operates an equity-settled, share-based compensation plan, under which the entity receives services from employees as consideration for equity instruments (e.g. options) of the Company. The fair value of the awards granted in exchange of the employee services received is recognized as an expense.
Non-market vesting conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each reporting period, the entity revises its estimates of the number of options that are expected to vest based on the non-market vesting conditions. It recognizes the impact of the revision to original estimates, if any, in the consolidated statements of loss, with a corresponding adjustment to equity. When options are exercised, the Company issues new shares. The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised.
The Company recognized the earnout consideration under the BCA as a share-based contingent consideration within the scope of IFRS 2, and therefore equity classified as the earnout consideration ultimately settles in ordinary shares. The Company determined that the fair value of the earnout shares is accounted for as a component of the deemed cost of the listing services upon consummation of the Business Combination. The fair value of total consideration transferred was included in the calculation of the IFRS 2 share listing service expense and will not be subsequently adjusted regardless of whether the price target is achieved or not. The earnout options granted to employees were determined to be compensation for the dilution to their previously held Legacy Oculis equity instruments. No subsequent compensation charge has been recognized under IFRS 2 because no additional fair value has been granted as a result of the earnout options.
The Company capitalizes transaction costs incurred in connection with its ATM program within other current assets in the Company’s consolidated balance sheet because those costs are directly attributable to new equity issuances and management estimates that a future financing is probably of occurring. If and when the Company completes a transaction, capitalized transaction costs will be offset against the proceeds and will be recorded as a reduction of share premium within the Company’s consolidated balance sheet. If the Company determines that it is not highly probable that a transaction will be completed, the Company will write-off capitalized transaction costs incurred during that respective quarter in the consolidated statement of loss.
Transaction costs incurred in connection with underwritten offerings are recorded as a reduction of share premium within the Company’s balance sheet during the period in which the transaction closes.
Effective January 1, 2025, the Company revised its accounting policy regarding the classification of interest paid and interest received in the statement of cash flows. Interest paid was reclassified from “net cash flows used in operating
93
activities” to “net cash flows used in financing activities,” and interest received was reclassified from “net cash flows used in operating activities” to “net cash flows used in investing activities.” The Company assessed the change in accounting policy under IAS 8, in accordance with the guidance regarding a voluntary change in accounting policy.
The reclassification of interest paid was elected to provide a more cohesive presentation of payments related to the Company’s office leases. Prior to the change in accounting policy, interest paid on lease liabilities was classified as operating cash flows, while payments of the principal portion of lease liabilities were classified as financing cash flows. The change aligns the interest paid with the associated financial liability giving rise to the interest.
In addition, the Company reclassified interest received to investing activities, as the majority of interest received relates to interest earned on cash and cash equivalents and short-term investments. The Company believes the updated classification better reflects the nature and source of the cash inflows.
The Company applied the change in accounting policy retrospectively and has recast prior periods’ comparative information within the statement of cash flows to ensure consistency and comparability with the current period presentation. As part of the retrospective application, net cash outflow from operating activities for the year ended December 31, 2024 increased by CHF 1.4 million, net cash outflow from investing activities decreased by CHF 1.5 million, and net cash flow inflow from financing activities decreased by CHF 54 thousand. As part of the retrospective application, net cash used in operating activities for the year ended December 31, 2023 increased by CHF 1.2 million, net cash flow used in investing activities decreased by CHF 1.2 million, and net cash flow inflow from financing activities decreased by CHF 46 thousand.
There are no new IFRS Accounting Standards, amendments to standards or interpretations that are mandatory for the financial year beginning on January 1, 2025 that have a material impact to the Company. In April 2024, the IASB issued IFRS 18, Presentation and Disclosure in Financial Statements, which provides requirements for the presentation and disclosure of information in general purpose financial statements. The standard is effective for periods beginning on or after January 1, 2027. The Company is in the process of evaluating whether IFRS 18 will have a material effect on the consolidated financial statements. New standards, amendments to standards and interpretations that are not yet effective, which have been deemed by the Company as currently not relevant, are not listed here.
The Group’s principal accounting policies are set out in Note 3 of the Group’s consolidated financial statements and conform to IFRS Accounting Standards. Significant judgments and estimates are used in the preparation of the consolidated financial statements which, to the extent that actual outcomes and results may differ from these assumptions and estimates, could affect the accounting in the areas described in this section.
The Group assesses whether there are any indicators of impairment for all licenses at each reporting date, which refers exclusively to the licenses of two specific product candidates: Licaminlimab (OCS-02) and Privosegtor (OCS-05). Given the stage and advancement of Oculis’ development activities and the importance of both products in Oculis’ portfolio, the impairment test is performed first on the basis of a fair value model for the entire Company using a market approach, and second on the basis of the continued development feasibility of the relevant product candidate. Refer to Note 9.
Deferred income tax assets are recognized for all unused tax losses and deductible temporary differences, including those related to intangible assets, only to the extent that it is probable that taxable profits will be available against which the losses and temporary differences can be utilized. Judgment is required from management to determine the amount of tax asset that can be recognized, based on forecasts and tax planning strategies. Refer to Note 7 (D).
The present value of the pension obligations depends on several factors that are determined on an actuarial basis using a number of assumptions. The assumptions used in determining the net cost or income for pensions include the discount rate. Any changes in these assumptions will impact the carrying amount of pension obligations. The independent actuary of the Group uses statistic-based assumptions covering future withdrawals of participants from the plan and estimates on life expectancy. The actuarial assumptions used may differ materially from actual results due to changes in market and
94
economic conditions, higher or lower withdrawal rates or longer or shorter life spans of participants. These differences could have a significant impact on the amount of pension income or expenses recognized in future periods.
The Group determines the appropriate discount rate at the end of each year. This is the interest rate used to determine the present value of estimated future cash outflows expected to be required to settle the pension obligations. In determining the appropriate discount rate, the Group considers the interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating the terms of the related pension liability. Other key assumptions for pension obligations are based in part on current market conditions. Refer to Note 12.
Stock options granted are valued using the Black-Scholes option-pricing model (see Note 13). This valuation model as well as inputs such as expected volatility and expected term of the stock options are partially based on management’s estimates. The expected volatility is estimated using historical stock volatilities of comparable peer public companies within the Company’s industry. The expected term represents the period that share-based awards are expected to be outstanding. The Company classifies its share-based payments as equity-classified awards as they are settled in ordinary shares. The Company measures equity-classified awards at their grant date fair value using a Black-Scholes option pricing model and does not subsequently remeasure them. Compensation costs related to equity-classified awards are equal to the fair value of the award at the date of grant amortized over the vesting period of the award using the graded method. If awards are granted with performance conditions, the Company evaluates the probability of achievement. Expense is only recorded for awards with vesting criteria linked to performance conditions that are deemed probable of achievement. The Company reclassifies a portion of vested awards to reserve for share-based payment as the awards vest. The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised.
In relation to the 2023 Business Combination, the following critical estimates and judgments were made:
Despite EBAC being the legal acquirer, Legacy Oculis was determined to be the accounting acquirer for financial reporting purposes. This determination is primarily based on the fact that subsequent to the Business Combination, i) the shareholders of Legacy Oculis have a majority of the voting interest in the combined company; ii) Legacy Oculis’ operations comprise all of the ongoing operations of the combined company; and iii) Legacy Oculis’ management comprise all of the senior management of the combined company.
EBAC was a Special Purpose Acquisition Company and therefore does not meet the definition of a business under IFRS 3 as it has no operations and the related BCA cannot be treated as a business combination. The Business Combination was accounted for as a continuation of Legacy Oculis financial statements with a deemed issuance of shares by the Company accompanied by a recapitalization of the Company’s equity. The excess of fair value of the shares deemed issued by the Company over EBAC’s identifiable net assets has been recorded as share-based payment expense in accordance with IFRS 2 and represents a public listing service received by the Company.
Legacy Oculis and EBAC incurred costs such as legal, accounting, auditing, printer fees and other professional fees directly related to the Business Combination (“Transaction Costs”). Transaction costs directly associated with equity issuance qualify for capitalization and are accounted for as a deduction of share premium. To capture costs associated with the new equity, the Company allocated capitalizable transaction costs to the various transaction components (equity issuance and listing) at the percentages of 38.0% and 62.0% for new shares and old shares, respectively.
95
Business combination with European Biotech Acquisition Corp. (“EBAC”)
On March 2, 2023, the Company consummated the Business Combination pursuant to the Business Combination Agreement (“BCA”) between Legacy Oculis and EBAC dated as of October 17, 2022. The Company received gross proceeds of CHF 97.6 million or $103.7 million, comprising CHF 12.0 million or $12.8 million of cash held in EBAC’s trust account and CHF 85.6 million or $90.9 million from private placement (the “PIPE Financing”) investments and conversion of notes issued by Legacy Oculis under convertible loan agreements (“CLA”) into Oculis’ ordinary shares. As a result of the transaction, each issued and outstanding EBAC public warrant (“BCA Public Warrants”) and EBAC private placement warrant (“BCA Private Warrants”) ceased to be a warrant with respect to EBAC ordinary shares and were assumed by Oculis as warrants with respect to ordinary shares on substantially the same terms (“BCA Warrants”). In connection with the Business Combination, Oculis was listed on the United States Nasdaq Global Market with the ticker symbol “OCS” for its ordinary shares and “OCSAW” for its public warrants.
During the third quarter of 2023, the Company gave effect in its financial statements to the dissolution of Merger Sub 2, a legal entity formed under the terms of the BCA. As a result, the cumulative translation adjustments related to Merger Sub 2 previously reported as equity and recognized in other comprehensive income, were reclassified from equity to the Consolidated Statement of Loss for the year ended December 31, 2023. The resulting foreign exchange impact of such reclassification amounted to CHF 5.0 million for the year ended December 31, 2023.
Merger and listing expense
The Business Combination was accounted for as a capital re-organization in the first quarter of 2023 within the scope of IFRS 2 Share-based Payment, as EBAC did not meet the definition of a business in accordance with IFRS 3 Business Combinations. Any excess of the fair value of the Company’s shares issued over the fair value of EBAC’s identifiable net assets acquired represented compensation for the service of a stock exchange listing. This expense was incurred in the first quarter of 2023 and amounted to CHF 34.9 million, which was expensed to the statement of loss as operating expenses, “Merger and listing expense.”
Earnout consideration
As a result of the BCA, Legacy Oculis preferred, ordinary and option holders (collectively “equity holders”) received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01.
The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post acquisition-closing volume weighted average share price targets of Oculis of $15.00, $20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028 (the “Earnout Period”). A given share price target described above will also be deemed to be achieved if the Company enters into a change of control transaction, as defined in the BCA, during the Earnout Period. The price targets of $15.00, $20.00 and $25.00 were met in November 2024, February 2025 and February 2026, respectively resulting in an aggregate of 2,845,446 earnout shares vested and 159,453 earnout options outstanding and exercisable as of December 31, 2025, and an additional 948,549 earnout shares vested and 55,487 earnout options becoming exercisable in February 2026.
Registered Direct Offering and Nasdaq Iceland Main Market listing
On April 22, 2024, the Company closed its registered direct offering with gross proceeds of CHF 53.5 million or $58.8 million through the issuance and sale of 5,000,000 of our ordinary shares, at a purchase price of CHF 10.70 or $11.75 per share to investors (the “Registered Direct Offering”), and commenced trading of its ordinary shares on the Nasdaq Iceland Main Market under the ticker symbol “OCS” on April 23, 2024. In connection with the Registered Direct Offering and Nasdaq Iceland Main Market listing, the Company incurred CHF 2.5 million of transaction related costs during the year ended December 31, 2024, of which CHF 1.9 million were recorded as a reduction of share premium in equity.
Loan facility
In May 2024, the Company and Kreos Capital VII (UK) Limited, which are funds and accounts managed by BlackRock, Inc. (the “Lender”), entered into a loan facility of up to CHF 50.0 million in borrowing capacity (which may be increased to up to CHF 65.0 million) and a related warrant agreement for up to 361,011 of the Company’s ordinary shares at a price per ordinary share equal to $12.17. On July 31, 2025, the Company entered into an amended and restated agreement for its
96
existing loan facility (the “Amended Loan Agreement”) with the Lender. The Amended Loan Agreement replaces the prior loan agreement between the Company and the Lender dated May 29, 2024, with an upsized structure to provide the EUR equivalent of up to CHF 75.0 million in borrowing capacity (which may be increased to up to CHF 100.0 million) (the “Loan”), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 25.0 million each, as well as an additional loan of the EUR equivalent of up to CHF 25.0 million, which may be made available by the Lender to the Company if mutually agreed in writing by the Lender and the Company. No amounts were drawn under the Amended Loan Agreement during the year ended December 31, 2025.
Loan 1 will be available for drawdown from closing until November 15, 2026, which period may be shortened upon the occurrence of a development milestone. Loans 2 and 3 will be available for drawdown prior to November 15, 2026 and December 31, 2026, respectively, in each case subject to satisfaction of certain pre-specified conditions. The availability of any funds under a drawdown of Loans 1, Loan 2 or Loan 3 is conditional upon, together with other conditions, the Company having a debt-to-market cap ratio (where debt includes the amount of all amounts drawn down to date and the proposed drawdown) equal to or less than 15% at the time of each draw down. Pursuant to the Amended Loan Agreement, the Company is subject to a non-utilization fee of 0.75% per annum of any undrawn amount under tranches 1 and 2. Additionally, to the extent Loan 1 has not been drawn prior to its expiry date, an additional one-time fee of the EUR equivalent of CHF 2.6 million shall be payable, subject to certain conditions.
As additional consideration for the Loan, Kreos Capital VII Aggregator SCSp, an affiliate of the Lender (the “Holder”) and the Company entered into an amended warrant (the “Amended BlackRock Warrant”) to purchase up to 494,259 of the Company’s ordinary shares, subject to vesting, at a price per ordinary share equal to $12.17 (CHF 9.65) with respect to 361,011 shares from the prior warrant agreement, and $18.64 (CHF 14.78) with respect to the remaining 133,248 shares reflecting the upsized facility, subject to adjustment. The Amended BlackRock Warrant amends the prior warrant issued to Holder on May 29, 2024. As of the signing date, the Amended BlackRock Warrant is exercisable for 59,310 ordinary shares, of which 43,321 shares were previously granted. Following the drawdown of each of Loans 1, 2 and 3, the Amended BlackRock Warrant will become exercisable for additional amounts of ordinary shares ratably based on the amounts of Loans 1, 2 and 3 that are drawn. Each tranche of the Amended BlackRock Warrant in connection with Loans 1, 2 and 3, will be exercisable for a period of up to seven years from the date of vesting and the Amended BlackRock Warrant will terminate at the earliest of (i) December 31, 2033, (ii) such earlier date on which the Amended BlackRock Warrant is no longer exercisable for any warrant shares in accordance with its terms and (iii) the acceptance by the shareholders of the Company of a third-party bona fide offer for all outstanding shares of the Company (subject to any prior exercise by the Holder, if applicable). The Amended BlackRock Warrant had not been exercised in part or in full as of December 31, 2025.
In connection with this transaction, the Company incurred CHF 0.7 million and CHF 0.8 million of transaction related costs during the years ended December 31, 2025 and 2024, respectively, which were capitalized as a prepayment for liquidity services and recorded within other current assets.
At-the-Market Offering Program
On May 8, 2024, the Company entered into a sales agreement with Leerink Partners, LLC (“Leerink Partners”) with respect to an at-the-market offering program (the “ATM Offering Program”) under which the Company may offer and sell, from time to time at its sole discretion, ordinary shares of the Company having an aggregate offering price of up to $100.0 million (CHF 79.3 million) through Leerink Partners as its sales agent. Any such sales, made through the sales agent, can be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, or in other transactions pursuant to an effective shelf registration statement on Form F-3. The Company agreed to pay Leerink Partners a commission of up to 3.0% of the gross proceeds of any sales of ordinary shares sold pursuant to the sales agreement. Following the execution of the agreement, the Company issued 1,000,000 ordinary shares during the year ended December 31, 2024 and 2,500,000 ordinary shares during the year ended December 31, 2025 out of its existing capital band, each with a nominal value of CHF 0.01 to be held as treasury shares. In connection with this transaction the Company incurred approximately CHF 0.3 million of transaction related costs during the year ended December 31, 2024, which were capitalized within other current assets.
On October 29, 2025, in conjunction with the November 2025 Offerings, the Company suspended the ATM Offering Program. The sales agreement with Leerink Partners remains in full force and effect. As of the date hereof, we have not sold any ordinary shares under the ATM Offering Program. Of the ordinary shares held as treasury shares, 2,796,297 were issued in connection with the November 2025 Offerings discussed below.
Public Offerings
May 2023 Offering
97
On May 31, 2023, the Company entered into an underwriting agreement with BofA Securities Inc. and SVB Securities, LLC, as representatives of several underwriters, and on June 5 and June 13, 2023, the Company closed the issuance and sale in a public offering of an aggregate of 3,654,234 ordinary shares at a public offering price of CHF 10.45 or $11.50 per share, for total gross proceeds of CHF 38.2 million or $42.0 million before deducting underwriting discounts, commissions and offering expenses.
February 2025 Offering
In February 2025, the Company closed an underwritten follow-on offering of 5,000,000 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.00 (CHF 18.05) per share, for total gross proceeds of $100.0 million (CHF 90.2 million). New shares were issued out of the Company’s existing capital band.
November 2025 Offerings
On November 3, 2025, the Company closed offerings of an aggregate of 5,432,098 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.25 (CHF 16.33) per share for total gross proceeds of $110.0 million (CHF 88.7 million) before deducting underwriting discounts and commissions and offering expenses. The Company issued 2,635,801 shares out of the Company’s existing capital band and 2,796,297 shares previously held in treasury by the Company.
The Company is managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business and accordingly, the Company has one reportable segment.
The table below provides the carrying amount of certain non-current assets, by geographic area:
|
|
Switzerland |
|
Others |
|
Total |
||||||
|
|
As of December 31, 2025 |
|
As of December 31, 2024 |
|
As of December 31, 2025 |
|
As of December 31, 2024 |
|
As of December 31, 2025 |
|
As of December 31, 2024 |
Intangible assets |
|
13,292 |
|
13,292 |
|
- |
|
- |
|
13,292 |
|
13,292 |
Property and equipment |
|
156 |
|
200 |
|
378 |
|
185 |
|
534 |
|
385 |
Right-of-use assets |
|
541 |
|
699 |
|
1,922 |
|
604 |
|
2,463 |
|
1,303 |
Total |
|
13,989 |
|
14,191 |
|
2,300 |
|
789 |
|
16,289 |
|
14,980 |
Grant income reflects reimbursement of research and development expenses, and income from certain research projects managed by Icelandic governmental institutions. Certain expenses qualify for incentives from the Icelandic government in the form of tax credits or cash reimbursements. Icelandic government grant income for the year ended December 31, 2025, 2024 and 2023 was CHF 1.2 million, CHF 0.7 million and CHF 0.9 million, respectively. Refer to Note 11.
The tables below show the breakdown of the operating expenses by category:
|
|
For the years ended December 31, |
|||||||||||||||||
|
|
Research and development expenses |
|
General and administrative expenses |
Total operating expenses |
||||||||||||||
|
|
2025 |
|
2024 |
|
2023 |
|
2025 |
|
2024 |
|
2023 |
|
2025 |
|
2024 |
|
2023 |
|
Personnel expenses |
|
18,849 |
|
11,114 |
|
6,509 |
|
14,997 |
|
11,476 |
|
7,029 |
|
33,846 |
|
22,590 |
|
13,537 |
|
Payroll and related expenses |
|
9,851 |
|
6,085 |
|
4,796 |
|
7,951 |
|
6,723 |
|
5,134 |
|
17,802 |
|
12,808 |
|
9,930 |
|
Share-based compensation expense |
|
8,998 |
|
5,029 |
|
1,713 |
|
7,046 |
|
4,753 |
|
1,895 |
|
16,044 |
|
9,782 |
|
3,607 |
|
Other operating expenses |
|
38,236 |
|
40,969 |
|
22,738 |
|
10,789 |
|
10,331 |
|
10,458 |
|
49,025 |
|
51,300 |
|
68,059 |
|
External service providers |
|
36,818 |
|
40,127 |
|
22,256 |
|
8,200 |
|
7,445 |
|
7,695 |
|
45,018 |
|
47,572 |
|
29,951 |
|
Other operating expenses |
|
1,077 |
|
573 |
|
258 |
|
2,384 |
|
2,749 |
|
2,700 |
|
3,461 |
|
3,322 |
|
2,958 |
|
Depreciation expense |
|
341 |
|
269 |
|
224 |
|
205 |
|
137 |
|
63 |
|
546 |
|
406 |
|
287 |
|
Merger and listing expense(1) |
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
34,863 |
|
Total |
|
57,085 |
|
52,083 |
|
29,247 |
|
25,786 |
|
21,807 |
|
17,487 |
|
82,871 |
|
73,890 |
|
81,597 |
|
(1) Merger and listing expense is presented separately from research and development or general and administrative expenses on the consolidated statements of loss. The item relates to the BCA and is non-recurring in nature, representing a share-based payment made in exchange for a listing service.
98
Total operating expenses increased CHF 9.0 million from December 31, 2024 to December 31, 2025. The increase was driven by a CHF 5.0 million increase in research and development expense and a CHF 4.0 million increase in general and administrative expense year over year.
The increase in research and development expenses was primarily due to advancements in our late-stage development portfolio, including Privosegtor development activities and the DIAMOND clinical program. The cost increases were partially offset by a decline in Licaminlimab development costs due to the completion of RELIEF Phase 2 trial in 2024 and commencement of PREDICT registrational trial in late 2025.
The increase in general and administrative costs was primarily driven by personnel costs, specifically share-based compensation expense due to increased headcount and increased grant value for awards granted during the year ended December 31, 2025.
|
For the years ended December 31, |
|||||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|
|||
Finance income |
|
1,770 |
|
|
|
2,168 |
|
|
|
1,429 |
|
|
Finance expense |
|
(833 |
) |
|
|
(639 |
) |
|
|
(1,315 |
) |
|
Fair value adjustment on warrant liabilities |
|
(12,294 |
) |
|
|
(15,531 |
) |
|
|
(3,431 |
) |
|
Foreign currency exchange gain (loss) |
|
(6,114 |
) |
|
|
1,269 |
|
|
|
(4,664 |
) |
|
Finance result |
|
(17,471 |
) |
|
|
(12,733 |
) |
|
|
(7,981 |
) |
|
Finance income in all periods presented consists primarily of interest income earned from the Company’s short-term financial assets.
The primary finance expense in 2025 and 2024 is the amortization of transaction costs related to the Loan Agreement, entered into during the second quarter of 2024 and amended in the third quarter of 2025. Refer to Note 5.
The Company had 2,045,596 shares of BCA Warrants and 59,310 ordinary shares of Blackrock Warrants outstanding at December 31, 2025. Warrants are adjusted to fair market value at each reporting date. Refer to Note 17 for further discussions of the fair value gain/(loss) on warrant liabilities.
For the year ended December 31, 2025, the foreign currency exchange loss is primarily related to overall weakening of the U.S. dollar against the Swiss Franc. During the year ended December 31, 2024, the foreign currency exchange gain is primarily related to overall strengthening of the U.S. dollar against the Swiss Franc.
Financial result as presented in the statements of cash flows is comprised of interest and the foreign exchange effect on cash and financial assets, net.
|
For the years ended December 31, |
|
|||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Current income tax expense |
|
(13 |
) |
|
|
(130 |
) |
|
|
(127 |
) |
Deferred tax income (expense) |
|
199 |
|
|
|
290 |
|
|
|
20 |
|
Total tax benefit (expense) |
|
186 |
|
|
|
160 |
|
|
|
(107 |
) |
The Group’s expected tax expense for each year is based on the applicable tax rate in each individual jurisdiction, which ranged between 8.3% and 25.0% for 2025, 2024 and 2023 in the tax jurisdictions in which the Group operates. The weighted average tax rates applicable to the profits of the consolidated entities were 12.8%, 13.7% and 12.7% for the years 2025, 2024 and 2023, respectively. The decrease in 2025 primarily reflects changes in the composition of taxable results.
The tax on the Group’s profit / (loss) before tax differs from the statutory amount that would arise using the weighted average applicable tax rate as follows:
99
|
For the years ended December 31, |
|
|||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Groups average expected tax rate |
|
12.8 |
% |
|
|
13.7 |
% |
|
|
12.7 |
% |
Accounting loss before income tax |
|
(99,143 |
) |
|
|
(85,937 |
) |
|
|
(88,695 |
) |
Taxes at weighted average income tax |
|
12,727 |
|
|
|
11,792 |
|
|
|
11,294 |
|
Effect of unrecognized tax losses |
|
(33,450 |
) |
|
|
(8,764 |
) |
|
|
(10,520 |
) |
Effect of use of unrecognized tax losses |
|
22,491 |
|
|
|
- |
|
|
|
- |
|
Effect of non-deductible expenses |
|
(3,434 |
) |
|
|
(3,098 |
) |
|
|
(6,041 |
) |
Effect of non-taxable income |
|
1,457 |
|
|
|
280 |
|
|
|
5,103 |
|
Effect of other items |
|
395 |
|
|
|
(50 |
) |
|
|
57 |
|
Total tax benefit (expense) |
|
186 |
|
|
|
160 |
|
|
|
(107 |
) |
During the year ended December 31, 2025, the Group changed its corporate structure and completed an intra-group sale of an intangible asset between two wholly-owned Swiss legal entities, generating an intra-group taxable profit of CHF 210.4 million. The intra-group sale of intangible asset combined with regular operational losses resulted in the use of CHF 160.6 million unrecognized tax losses to offset the taxable income in the transferring Swiss entity, resulting in a reconciling effect of use of unrecognized tax losses of CHF 22.5 million.
The transaction created future temporary difference of CHF 210.4 million in the receiving Swiss entity due to the differences between the statutory and the IFRS carrying values of the transferred intangible asset. The amortization of the transferred intangible asset will commence when the market approval for the underlying asset is obtained. Given the uncertainty in the realization of future taxable profits, no deferred tax asset on these future temporary differences has been recognized as of December 31, 2025.
As of December 31, 2025, 2024 and 2023, the Group has accumulated tax losses, primarily in Switzerland. These losses may be carried forward to offset future taxable profits of the Company until expiration. However, no deferred tax assets have been recognized related to these losses as of December 31, 2025 as the realization of sufficient future taxable profits is not considered probable. Additionally, as certain tax losses have not yet been validated by the tax authorities, they remain subject to potential adjustments. The combined effect of unrecognized tax losses and intangible asset temporary differences amounted to CHF 33.5 million. This does not affect management’s assumption on the going concern hypothesis of the Group. Below is the maturity of the Group reportable losses:
|
As of December 31, |
|
|||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
2025 |
|
- |
|
|
|
16,733 |
|
|
|
16,733 |
|
2026 |
|
- |
|
|
|
13,113 |
|
|
|
13,113 |
|
2027 |
|
- |
|
|
|
12,437 |
|
|
|
12,437 |
|
2028 |
|
- |
|
|
|
14,865 |
|
|
|
14,865 |
|
2029 |
|
- |
|
|
|
31,786 |
|
|
|
31,786 |
|
2030 |
|
41,396 |
|
|
|
81,509 |
|
|
|
81,509 |
|
2031 |
|
31,795 |
|
|
|
63,397 |
|
|
|
- |
|
2032 |
|
33,670 |
|
|
|
- |
|
|
|
- |
|
Total |
|
106,861 |
|
|
|
233,840 |
|
|
|
170,443 |
|
The Group did not recognize the following temporary differences:
|
As of December 31, |
|
|||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Pension |
|
1,335 |
|
|
|
1,870 |
|
|
|
728 |
|
Tax losses in Switzerland |
|
106,861 |
|
|
|
233,840 |
|
|
|
170,443 |
|
Leases |
|
(150 |
) |
|
|
(123 |
) |
|
|
(150 |
) |
Intangible asset |
|
206,403 |
|
|
|
(4,025 |
) |
|
|
(4,025 |
) |
Total |
|
314,449 |
|
|
|
231,562 |
|
|
|
166,996 |
|
The abovementioned intra-group sale transaction generated future temporary differences of CHF 210.4 million in the receiving Swiss entity and reduced accumulated tax losses by an amount of CHF 160.6 million as of December 31, 2025.
100
8. PROPERTY AND EQUIPMENT
The following table presents the movements in the book values of property and equipment:
|
Lab - equipment |
|
|
Lab - fixtures and fittings |
|
|
Office equipment & hardware |
|
|
Leasehold improvement |
|
|
Total |
|
|||||
Acquisition cost: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2023 |
|
618 |
|
|
|
195 |
|
|
|
151 |
|
|
|
- |
|
|
|
964 |
|
Additions |
|
10 |
|
|
|
- |
|
|
|
122 |
|
|
|
98 |
|
|
|
230 |
|
Balance as of December 31, 2024 |
|
628 |
|
|
|
195 |
|
|
|
273 |
|
|
|
98 |
|
|
|
1,194 |
|
Additions |
|
126 |
|
|
|
- |
|
|
|
95 |
|
|
|
80 |
|
|
|
301 |
|
Disposals |
|
(53 |
) |
|
|
- |
|
|
|
(9 |
) |
|
|
- |
|
|
|
(62 |
) |
Balance as of December 31, 2025 |
|
701 |
|
|
|
195 |
|
|
|
359 |
|
|
|
178 |
|
|
|
1,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Accumulated depreciation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2023 |
|
(464 |
) |
|
|
(106 |
) |
|
|
(106 |
) |
|
|
- |
|
|
|
(676 |
) |
Depreciation expense |
|
(84 |
) |
|
|
(19 |
) |
|
|
(20 |
) |
|
|
(10 |
) |
|
|
(133 |
) |
Balance as of December 31, 2024 |
|
(548 |
) |
|
|
(125 |
) |
|
|
(126 |
) |
|
|
(10 |
) |
|
|
(809 |
) |
Depreciation expense |
|
(66 |
) |
|
|
(20 |
) |
|
|
(37 |
) |
|
|
(29 |
) |
|
|
(152 |
) |
Disposals |
|
53 |
|
|
|
- |
|
|
|
9 |
|
|
|
- |
|
|
|
62 |
|
Balance as of December 31, 2025 |
|
(561 |
) |
|
|
(145 |
) |
|
|
(154 |
) |
|
|
(39 |
) |
|
|
(899 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Carrying amount: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2024 |
|
80 |
|
|
|
70 |
|
|
|
147 |
|
|
|
89 |
|
|
|
385 |
|
Balance as of December 31, 2025 |
|
140 |
|
|
|
50 |
|
|
|
205 |
|
|
|
139 |
|
|
|
534 |
|
The following tables summarize the movement of intangibles assets, all of which represent licenses:
|
|
Total |
|
|
Acquisition cost: |
|
|
|
|
Balance as of December 31, 2023 |
|
|
12,206 |
|
Additions |
|
|
1,086 |
|
Balance as of December 31, 2024 |
|
|
13,292 |
|
Balance as of December 31, 2025 |
|
|
13,292 |
|
Intangible assets as of both December 31, 2025 and 2024 were CHF 13.3 million, and represented licenses purchased under license agreements with Novartis and Accure. The Novartis license agreement was dated as of December 19, 2018 between Legacy Oculis and Novartis and relates to a novel topical anti-TNFα antibody, renamed Licaminlimab, for ophthalmic indications. The license agreement between Legacy Oculis and Accure, dated as of January 29, 2022, relates to the exclusive global licensing of its Privosegtor (formerly ACT-01) technology. This license agreement contained an upfront payment of CHF 3.0 million and reimbursement of development related costs of CHF 0.5 million. During the fourth quarter of 2024, the Company completed the Phase 2 ACUITY trial of Privosegtor in ON and received clearance from the U.S. Food and Drug Administration (“FDA”) for its investigational new drug (“IND”). These events triggered milestone payments to Accure totaling CHF 1.1 million which were capitalized, increasing the value of the intangible asset. The next clinical and regulatory milestone under the Accure Agreement will trigger a payment of CHF 2.1 million ($2.6 million) that the Company expects to pay in 2026.
101
The products candidates related to the capitalized intangible assets are not yet available for use. The amortization of the licenses will start when the market approval is obtained.
Oculis performs an assessment of its licenses in the context of its annual impairment test. Given the stage of Oculis’ development activities and the importance of the relevant product candidates, Licaminlimab and Privosegtor, in Oculis’ portfolio, the impairment test is performed first on the basis of a fair value model for the entire Company using a market approach and second on the basis of the continued development feasibility of both candidates.
Oculis performs its annual impairment tests on its entire portfolio of research and development assets, by deriving the fair value from an observable valuation for the entire Company determined via its stock market price quoted in Nasdaq as per the reporting date. The fair value of the asset portfolio is derived by deducting the carrying value of tangible assets and the remaining assets, which consist primarily of short-term financial assets and cash and cash equivalents, from the Company valuation.
Licaminlimab and Privosegtor, are additionally tested for impairment by assessing their probability of success. Assessments include reviews of the following indicators, and if the candidate fails any of these indicators the entire balance is written off:
In 2025, 2024 and 2023, reviews of all these indicators for Licaminlimab and Privosegtor were positive. No impairment losses were recognized in 2025, 2024 or 2023.
The following table presents the right-of-use assets, which are related to the Company’s Switzerland, Iceland and U.S. facilities:
|
Right-of-use assets |
|
|||||
|
2025 |
|
|
2024 |
|
||
Balance as of January 1, |
|
1,303 |
|
|
|
755 |
|
Indexation for the period |
|
20 |
|
|
|
25 |
|
New leases |
|
1,530 |
|
|
|
792 |
|
FX revaluation |
|
4 |
|
|
|
4 |
|
Depreciation charge for the period |
|
(394 |
) |
|
|
(273 |
) |
Balance as of December 31, |
|
2,463 |
|
|
|
1,303 |
|
During the year ended December 31, 2025, the Company signed a new lease in the U.S. commencing July 1, 2025 and a new lease in Iceland commencing September 1, 2025.
There are no variable lease payments which are not included in the measurement of lease obligations. Expected extension options have been included in the measurement of lease liabilities.
102
The following table presents the lease obligations:
|
Lease liabilities |
|
|||||
|
2025 |
|
|
2024 |
|
||
Balance as of January 1, |
|
(1,180 |
) |
|
|
(605 |
) |
New leases |
|
(1,530 |
) |
|
|
(792 |
) |
FX revaluation |
|
44 |
|
|
|
(32 |
) |
Indexation for the period |
|
(20 |
) |
|
|
(25 |
) |
Interest expense for the period |
|
(87 |
) |
|
|
(47 |
) |
Lease payments for the period |
|
460 |
|
|
|
321 |
|
Balance as of December 31, |
|
(2,313 |
) |
|
|
(1,180 |
) |
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||
Current |
|
(502 |
) |
|
|
(315 |
) |
Non-current |
|
(1,811 |
) |
|
|
(865 |
) |
Total |
|
(2,313 |
) |
|
|
(1,180 |
) |
The table below shows the breakdown of the other current assets by category:
|
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||
Prepaid clinical and technical development expenses |
|
|
1,590 |
|
|
|
2,615 |
|
Prepaid general and administrative expenses |
|
|
2,492 |
|
|
|
2,105 |
|
VAT, withholding tax and interest receivables |
|
|
801 |
|
|
|
885 |
|
Total |
|
|
4,883 |
|
|
|
5,605 |
|
The decrease in prepaid clinical and technical development expenses as of December 31, 2025 compared to prior year relates primarily to advancements of clinical trials. Specifically, the OCS-01 DIAMOND-1 and DIAMOND-2 trials in DME which started in December 2023 and February 2024, respectively, with enrollments completed in April 2025. The increase in prepaid general and administrative expenses is primarily due to capitalized transaction costs associated with the Company’s ATM Offering Program and Amended Loan Agreement.
The table below shows the movement of the accrued income for the years ended December 31, 2025 and 2024:
|
|
2025 |
|
|
2024 |
|
||
Balance as of January 1, |
|
|
629 |
|
|
|
876 |
|
Accrued income recognized during the period |
|
|
1,199 |
|
|
|
686 |
|
Payments received during the period |
|
|
(617 |
) |
|
|
(952 |
) |
Foreign exchange revaluation |
|
|
(218 |
) |
|
|
19 |
|
Balance as of December 31, |
|
|
993 |
|
|
|
629 |
|
Accrued income is generated by incentives for research and development offered by the Icelandic government in the form of tax credits for innovation companies. These tax credits are either used to reduce the company’s income tax liability or, if the credits exceed the tax due, they are paid out in cash. The tax credit is subject to companies having a research project approved as eligible for tax credit by the Icelandic Centre for Research (Rannís).
The Company’s Swiss pension plan is classified as a defined benefit plan under IFRS Accounting Standards. Employees of the Icelandic, French, Hong Kong and American subsidiaries are covered by local post-retirement contribution plans. Besides the Swiss plan, all other pension plans are not material to the Company’s consolidated financial position or results.
103
Switzerland pension plan
The Company’s Swiss entity is affiliated to a collective foundation administrating the pension plans of various unrelated employers that qualifies as defined benefit plan under IAS 19. For employees in Switzerland, the pension fund provides post-employment, death-in-service and disability benefits in accordance with the Swiss Federal Law on Occupational Retirement, Survivor’s and Disability Pension Plans which specifies the minimum benefits that are to be provided.
The pension plan of the Company’s Swiss entity is fully segregated from the ones of other participating employers. The collective foundation has reinsured all risks with an insurance company. The most senior governing body of the collective foundation is the Board of Trustees. All governing and administration bodies have an obligation to act in the interests of the plan beneficiaries.
The retirement benefits are based on the accumulated retirement capital, which is made of the yearly contributions towards the old age risk by both employer and employee and the interest thereon until retirement. The employee contributions are determined based on the insured salary, depending on the age, staff level and saving amount of the beneficiary. The interest rate is determined annually by the governing body of the collective plan in accordance with the legal framework, which defines the minimum interest rates.
If an employee leaves the pension plan before reaching retirement age, the law provides for the transfer of the vested benefits to a new pension plan. These vested benefits comprise the employee and the employer contributions plus interest, the money originally brought into the pension plan by the beneficiary and an additional legally stipulated amount. On reaching retirement age, the plan beneficiary may decide whether to withdraw the benefits in the form of an annuity or (entirely or partly) as a lump-sum payment. The annuity is calculated by multiplying the balance of the retirement capital with the applicable conversion rate.
All actuarial risks of the plan, e.g. old age, invalidity and death-in-service or investment, are fully covered by insurance. However, the collective foundation is able to withdraw from the contract with the Company at any time, in which case the Company would be required to join another pension plan. In addition, the risk premiums may be adjusted by the insurance company periodically.
The Company’s Swiss pension plan is fully reinsured with Swiss Life, therefore the plan assets are 100% covered by an insurance contract. The insurance company bearing the investment risk is also making these investments on behalf of the collective foundation. As a result, the assets of the plan consist of a receivable from the insurance police.
The assets are invested by the pension plan, to which many companies contribute, in a diversified portfolio that respects the requirements of the Swiss Law. The insurance policy has been treated as a qualifying insurance policy and therefore the pension assets are presented as one asset and are not desegregated and presented in classes that distinguish the nature and risks of those assets.
The following tables summarize the components of net benefit expense recognized in the consolidated statements of loss, amounts recognized in the balance sheet and gains/(losses) recognized in other comprehensive loss.
|
|
For the years ended December 31, |
|
|||||
Actuarial gains / (losses) recognized in other comprehensive loss: |
|
2025 |
|
|
2024 |
|
||
On plan assets |
|
|
(1 |
) |
|
|
(71 |
) |
On obligation |
|
|
600 |
|
|
|
(1,090 |
) |
Total |
|
|
599 |
|
|
|
(1,161 |
) |
|
|
For the years ended December 31, |
|
|||||
Net benefit expense: |
|
2025 |
|
|
2024 |
|
||
Service cost |
|
|
(975 |
) |
|
|
(663 |
) |
Interest cost on benefit obligation |
|
|
(134 |
) |
|
|
(143 |
) |
Interest income |
|
|
119 |
|
|
|
133 |
|
Administration cost |
|
|
(18 |
) |
|
|
(15 |
) |
Net benefit expense |
|
|
(1,008 |
) |
|
|
(688 |
) |
104
|
|
For the years ended December 31, |
|
|||||
Benefit liability |
|
2025 |
|
|
2024 |
|
||
Defined benefit obligation |
|
|
(15,998 |
) |
|
|
(13,715 |
) |
Fair value of plan assets |
|
|
14,663 |
|
|
|
11,845 |
|
Net benefit liability |
|
|
(1,335 |
) |
|
|
(1,870 |
) |
Changes in the present value of the defined benefit obligation are as follows:
|
|
For the years ended December 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Defined benefit obligation at January 1, |
|
|
(13,715 |
) |
|
|
(9,930 |
) |
Interest cost |
|
|
(134 |
) |
|
|
(143 |
) |
Service cost |
|
|
(975 |
) |
|
|
(663 |
) |
Administrative expenses |
|
|
(18 |
) |
|
|
(15 |
) |
Contributions paid by participants |
|
|
(2,711 |
) |
|
|
(3,179 |
) |
Employees’ contributions |
|
|
(408 |
) |
|
|
(312 |
) |
Benefits paid from plan assets |
|
|
1,363 |
|
|
|
1,617 |
|
Actuarial gains / (losses) |
|
|
600 |
|
|
|
(1,090 |
) |
Defined benefit obligation at December 31, |
|
|
(15,998 |
) |
|
|
(13,715 |
) |
Changes in the fair value of plan assets are as follows:
|
|
For the years ended December 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Fair value of plan assets at January 1, |
|
|
11,845 |
|
|
|
9,202 |
|
Expected return |
|
|
119 |
|
|
|
133 |
|
Contributions by employer |
|
|
944 |
|
|
|
707 |
|
Employees’ contributions |
|
|
408 |
|
|
|
312 |
|
Benefits paid from plan assets |
|
|
(1,363 |
) |
|
|
(1,617 |
) |
Contributions paid by participants |
|
|
2,711 |
|
|
|
3,179 |
|
Actuarial losses |
|
|
(1 |
) |
|
|
(71 |
) |
Fair value of plan assets at December 31, |
|
|
14,663 |
|
|
|
11,845 |
|
The Group expects to contribute CHF 0.7 million to its defined benefit pension plan in 2026. The average duration of the plan was 14.3 years and 14.6 years as of December 31, 2025 and 2024, respectively.
The principal assumptions used in determining pension benefit obligations for the Group’s plan are shown below:
|
|
For the years ended December 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Discount rate |
|
|
1.30 |
% |
|
|
1.00 |
% |
Future salary increases |
|
|
0.75 |
% |
|
|
1.00 |
% |
Future pensions increases |
|
|
0.00 |
% |
|
|
0.00 |
% |
Retirement age |
|
|
65 |
|
|
|
65 |
|
Demographic assumptions |
|
BVG 2020 |
|
|
BVG 2020 |
|
||
In regard to the underlying estimates for the calculation of the defined benefit pension liabilities the Company updated, among other minor updates, the discount rate assumption to 1.30% and 1.00% and the future salary increase assumption from 1.00% to 0.75% as of December 31, 2025 and 2024, respectively. All the actuarial assumption changes resulted in an actuarial gain of defined benefit pension liabilities of CHF 0.6 million. The net result is a decrease of defined benefit pension liabilities from CHF 1.9 million as of December 31, 2024 to CHF 1.3 million as of December 31, 2025. Other assumptions for defined benefit pension liabilities remain unchanged.
In 2025, the guaranteed interest to be credited to employees’ savings remains consistent with 2024 at 1.10%. The rate for converting mandatory savings to an annuity remains stable at 5.40% for males and 5.57% for females in 2026 and increases to 5.71% for females in 2027. The rate for converting supplementary savings to an annuity remains stable at 4.49% for males and 4.67% for females in 2026 and increases to 4.82% in 2027.
105
Sensitivity analysis
A quantitative sensitivity analysis for significant assumptions as of December 31, 2025 and 2024 is shown below:
|
Discount rate |
|
|
Future salary |
|
|
Mortality |
|
||||||||||||
Assumptions as of December 31, 2025 |
+0.25% |
|
-0.25% |
|
|
+0.50% |
|
-0.50% |
|
|
+1 year |
|
-1 year |
|
||||||
Potential defined benefit obligation |
|
(15,466 |
) |
|
(16,597 |
) |
|
|
(16,129 |
) |
|
(15,872 |
) |
|
|
(16,153 |
) |
|
(15,844 |
) |
Decrease/(increase) from actual defined benefit obligation |
|
532 |
|
|
(599 |
) |
|
|
(131 |
) |
|
126 |
|
|
|
(155 |
) |
|
154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Assumptions as of December 31, 2024 |
+0.25% |
|
-0.25% |
|
|
+0.50% |
|
-0.50% |
|
|
+1 year |
|
-1 year |
|
||||||
Potential defined benefit obligation |
|
(13,226 |
) |
|
(14,236 |
) |
|
|
(13,828 |
) |
|
(13,607 |
) |
|
|
(13,844 |
) |
|
(13,589 |
) |
Decrease/(increase) from actual defined benefit obligation |
|
490 |
|
|
(521 |
) |
|
|
(112 |
) |
|
108 |
|
|
|
(129 |
) |
|
126 |
|
The sensitivity analysis above is subject to limitations and has been determined based on a method that extrapolates the impact on net defined benefit obligation as a result of reasonable changes in key assumptions occurring at the end of the reporting period.
On March 2, 2023, the Company adopted the Stock Option and Incentive Plan Regulation 2023 (the “2023 Plan”) which allows for the grant of equity incentives, including share-based options, stock appreciation rights (“SARs”), restricted stock units (“RSUs”) and other awards. The 2023 Plan lays out the details for the equity incentives for talent acquisition and retention purposes.
Each grant of share-based options made under the 2023 Plan entitles the grantee to acquire ordinary shares from the Company with payment of the exercise price in cash. In the case of SARs, the intention of the Company is settling in equity. For each grant of share-based options or SARs, the Company issues a grant notice, which details the terms of the options or SARs, including number of shares, exercise price, vesting conditions and expiration date. Options granted under the 2023 Plan vest over periods ranging from one to four years and expire one day before the tenth anniversary of the grant date. The specific terms of each grant are set by the Board of Directors.
The 2023 Plan reflects the revised capital structure of the Company following completion of the Business Combination in March 2023. As a result, all option holders holding options under the prior Stock Option and Incentive Plan Regulation 2018 (the“2018 Plan”) prior to the close of the Business Combination exchanged their options held in Legacy Oculis for newly issued options to purchase ordinary shares of Oculis (“Converted Options”) and additional earnout options. The Converted Options continue to be subject to substantially the same terms and conditions except that the number of ordinary shares of Oculis issuable and related exercise prices were adjusted by the Exchange Ratio with all other terms remaining unchanged. The comparative fair value calculation of options using the Black-Scholes model before and after the merger concluded that there was no significant change in value. The exchange of equity awards under the prior 2018 Plan for equity awards under the 2023 Plan was determined to be a modification in accordance with IFRS 2 – Share-based payment. The Group has and will continue to record the related expense per the original valuation and vesting period without incremental charges.
Option awards and SARs
Each share-based option or SAR granted under the 2023 Plan entitles the grantee to acquire common shares from the Company with cash payment of the exercise price. For each grant of share-based options or SARs, the Company provides a grant notice which details the terms of the option, including exercise price, vesting conditions and expiration date. The terms of each grant are set by the Board of Directors.
The fair value of option awards and SARs is determined using the Black-Scholes option-pricing model. The weighted average grant date fair value of options granted during the year ended December 31, 2025 was CHF 11.77 or $14.17 per share. The weighted average grant date fair value of options and SARs granted during the year ended December 31, 2024 was CHF 7.80 or $8.85 per share. The weighted average grant date fair value of options granted during the year ended December 31, 2023 was CHF 5.24 or $5.83 per share.
106
The Black-Scholes fair value of SARs was determined using assumptions that were not materially different from those used to value options. The following assumptions were used in the Black-Scholes option-pricing model for determining the fair value of options and SARs granted during the years indicated:
|
|
For the years ended December 31, |
||||
|
|
2025 |
|
2024 |
|
2023 |
Weighted average share price at the date of grant (1) |
|
USD 18.39 (CHF 15.28) |
|
USD 11.63 (CHF 10.24) |
|
USD 8.30 (CHF 7.46) |
Range of expected volatilities (%) (2) |
|
81.84-91.39 |
|
85.54-93.00 |
|
68.70-83.80 |
Range of expected terms (years) (3) |
|
6.25 |
|
5.50-6.25 |
|
6.25 |
Range of risk-free interest rates (%) (1)(4) |
|
3.7-4.3 |
|
3.6-4.6 |
|
3.5-4.8 |
Dividend yield (%) |
|
0.0 |
|
0.0 |
|
0.0 |
The following table summarizes the Company’s stock option and SARs activity under the 2023 Plan for 2023 to 2025:
|
|
Number of options (1) |
|
|
Weighted average exercise price (1) (CHF) |
|
|
Range of expiration dates |
||
Outstanding as of January 1, 2023 |
|
|
1,762,949 |
|
|
|
2.39 |
|
|
2027-2031 |
Options granted(2) |
|
|
1,614,000 |
|
|
|
7.49 |
|
|
2033 |
SARs granted |
|
|
134,765 |
|
|
|
7.27 |
|
|
2033 |
Earnout options granted |
|
|
369,737 |
|
|
|
0.01 |
|
|
2028 |
Forfeited(2)(3) |
|
|
(302,299 |
) |
|
|
2.62 |
|
|
2033 |
Exercised(3) |
|
|
(112,942 |
) |
|
|
2.43 |
|
|
2028-2032 |
Outstanding as of December 31, 2023 |
|
|
3,466,210 |
|
|
|
4.50 |
|
|
2027-2033 |
Exercisable at December 31, 2023 |
|
|
1,164,513 |
|
|
|
2.21 |
|
|
2028-2033 |
Outstanding as of January 1, 2024 |
|
|
3,466,210 |
|
|
|
4.50 |
|
|
2027-2033 |
Options granted |
|
|
1,811,122 |
|
|
|
10.24 |
|
|
2034 |
Forfeited(3) |
|
|
(288,767 |
) |
|
|
4.38 |
|
|
2028-2034 |
Exercised(3) |
|
|
(301,511 |
) |
|
|
3.17 |
|
|
2027-2033 |
Outstanding as of December 31, 2024 |
|
|
4,687,054 |
|
|
|
6.82 |
|
|
2028-2034 |
Exercisable at December 31, 2024 |
|
|
1,935,101 |
|
|
|
4.34 |
|
|
2028-2034 |
Outstanding as of January 1, 2025 |
|
|
4,687,054 |
|
|
|
6.82 |
|
|
2028-2034 |
Options granted |
|
|
1,227,131 |
|
|
|
15.28 |
|
|
2035 |
Forfeited(3) |
|
|
(387,146 |
) |
|
|
10.53 |
|
|
2028-2035 |
Exercised(3) |
|
|
(363,093 |
) |
|
|
5.19 |
|
|
2028-2034 |
Outstanding as of December 31, 2025 |
|
|
5,163,946 |
|
|
|
8.32 |
|
|
2028-2035 |
Exercisable at December 31, 2025 |
|
|
2,661,095 |
|
|
|
5.27 |
|
|
2028-2035 |
Excluding earnout options, which have an exercise price of CHF 0.01, options outstanding as of December 31, 2025 have exercise prices ranging from CHF 1.63 to CHF 17.10. The weighted average remaining contractual life of options and SARs outstanding as of December 31, 2025 and 2024 was seven and eight years, respectively.
107
Restricted stock units
Each RSU granted under the 2023 Plan entitles the grantee to one ordinary share upon vesting of the RSU. The Company intends to settle all outstanding RSUs in equity. The fair value of RSUs is determined by the closing stock price on the date of grant and the related compensation cost is amortized over the vesting period of the award using the graded method. RSU’s have time-based vesting conditions ranging from one to four years. Certain RSU’s also include a performance condition, for which the Company has evaluated the probability of achievement. Expense is only recorded for awards with vesting criteria linked to performance conditions that are deemed probable of achievement. The following table summarizes the Company’s RSU activity under the 2023 Plan for the years ended December 31, 2025 and 2024:
|
|
2025 |
|
2024 |
|
|||||||||||||||||
|
|
Number of awards |
|
|
Weighted average grant date fair value (CHF) |
|
|
Range of expiration dates |
|
Number of awards |
|
|
Weighted average grant date fair value (CHF) |
|
|
Range of expiration dates |
|
|||||
Outstanding as of January 1, |
|
|
467,478 |
|
|
|
9.81 |
|
|
2034 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
RSUs granted |
|
|
714,813 |
|
|
|
15.36 |
|
|
2035 |
|
|
476,908 |
|
|
|
9.83 |
|
|
2034 |
|
|
RSUs vested/released |
|
|
(174,655 |
) |
|
|
10.24 |
|
|
2034-2035 |
|
|
(9,430 |
) |
|
|
10.51 |
|
|
2034 |
|
|
Outstanding as of December 31, |
|
|
1,007,636 |
|
|
|
13.93 |
|
|
2034-2035 |
|
|
467,478 |
|
|
|
9.81 |
|
|
2034 |
|
|
Restricted share awards
Each restricted share award (“RSA”) granted under the 2018 Plan was immediately exercised and the expense was recorded at fair value on the grant date in full. The Company held call options to repurchase shares diminishing ratably on a monthly basis over three years from grant date, the last of which expired during 2024. As of December 31, 2023, 98,094 RSA’s were subject to repurchase. No RSA’s were subject to repurchase at December 31, 2024 or 2025. For each grant of restricted shares, the Company issued a grant notice, which detailed the terms of the grant, including the number of awards, repurchase right start date and expiration date. The terms of each grant were set by the Board of Directors. No RSAs were granted under the 2023 Plan since plan adoption. No expense was recognized during the years ended December 31, 2025, 2024 or 2023 related to restricted stock awards.
Share-based compensation expense
The following table details share-based compensation expense by award type for the years indicated:
|
|
For the years ended December 31, |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Stock options |
|
|
9,662 |
|
|
|
8,218 |
|
|
|
3,608 |
|
RSUs |
|
|
6,382 |
|
|
|
1,564 |
|
|
|
- |
|
Total share-based compensation expense |
|
|
16,044 |
|
|
|
9,782 |
|
|
|
3,608 |
|
The reserve for share-based payment increased from CHF 6.4 million as of December 31, 2023 to CHF 16.1 million as of December 31, 2024, and to CHF 30.4 million as of December 31, 2025. During the year ended December 31, 2025, certain RSUs that included a performance condition were modified such that the condition had been met, resulting in CHF 0.3 million of additional share-based compensation expense during the year ended December 31, 2025. During the year ended December 31, 2024, certain options were modified to accelerate vesting upon the death of an employee, resulting in the acceleration of expense recognition of CHF 1.0 million.
108
The table below shows the breakdown of the cash and cash equivalents and short-term financial assets by currencies:
|
|
Cash and cash equivalents |
|
|
Short-term financial assets |
|
||||||||||
by currency |
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||||
Swiss Franc |
|
|
45,716 |
|
|
|
2,810 |
|
|
|
126,000 |
|
|
|
61,000 |
|
US Dollar |
|
|
33,766 |
|
|
|
15,234 |
|
|
|
1,031 |
|
|
|
9,955 |
|
Euro |
|
|
539 |
|
|
|
8,960 |
|
|
|
4,653 |
|
|
|
- |
|
Iceland Krona |
|
|
440 |
|
|
|
648 |
|
|
|
- |
|
|
|
- |
|
Other |
|
|
868 |
|
|
|
56 |
|
|
|
- |
|
|
|
- |
|
Total |
|
|
81,329 |
|
|
|
27,708 |
|
|
|
131,684 |
|
|
|
70,955 |
|
Cash and cash equivalents consist primarily of cash balances held at banks. Short-term financial assets consist of fixed term bank deposits with maturities between three and nine months.
15. SHAREHOLDERS’ EQUITY
The conditional capital at December 31, 2025 amounted to a maximum of CHF 235,752.08 split into 23,575,208 ordinary shares, in connection with the potential future issuances of:
CHF 67,500.00 through the issuance of a maximum of 6,750,000 fully paid-up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of convertible rights and/or option rights or warrants, new bonds and similar debt instruments.
CHF 124,800.00 through the issuance of a maximum of 12,480,000 fully paid-up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of option rights or other equity-linked instruments granted to any employee, consultant or member of the Board of Directors of Oculis.
During the year ended December 31, 2025, 363,093 stock options have been exercised and 174,655 RSUs vested resulting in the associated ordinary shares issued using the conditional share capital for employee benefit plans (refer to Note 13). These shares were not registered yet in the commercial register as of December 31, 2025.
CHF 39,751.05 through the issuance of a maximum of 3,975,105 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of warrants.
During the year ended December 31, 2025, 1,929,467 warrants have been exercised and associated ordinary shares have been issued using the conditional share capital for BCA public and private warrants (refer to Note 17). These shares were not registered yet in the commercial register as of December 31, 2025.
CHF 3,701.03 through the issuance of a maximum of 370,103 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of option rights or other equity-linked instruments granted to any employee, consultant or member of the Board of Directors of Oculis. As of December 31, 2025, 159,453 earnout options were exercisable.
The Company cancelled 100,000 treasury shares effective March 2, 2023 as a result of the Business Combination. In connection with the ATM Offering Program, the Company issued 1,000,000 ordinary shares during the year ended December 31, 2024 and 2,500,000 ordinary shares during the year ended December 31, 2025 out of its existing capital
109
band, each with a nominal value of CHF 0.01 to be held as treasury shares. There were no sales under the ATM Offering Program during the year ended December 31, 2025. In connection with the November 2025 Offerings, the Company issued 2,796,297 shares previously held in treasury by the Company.
(D) Capital band
As of December 31, 2025, the Company’s capital band has a lower limit of CHF 545,336.74 and upper limit of CHF 818,005.11. The Company may effect an increase of the Company’s share capital in a maximum amount of CHF 272,668.37 by issuing up to 27,266,837 ordinary shares with a par value of CHF 0.01 each out of the Company’s capital band. The Board of Directors is authorized to increase the share capital to the upper limit or decrease the share capital to the lower limit at any time and as often as required until June 4, 2030.
16. TRADE PAYABLES, ACCRUED EXPENSES AND OTHER PAYABLES
Trade payables decreased from CHF 5.9 million as of December 31, 2024 to CHF 1.8 million as of December 31, 2025. The decrease in trade payables compared to prior year relates to the commencement of several clinical trials in the fourth quarter of 2024 requiring up-front invoicing by vendors.
The table below shows the breakdown of the accrued expenses and other payables by category:
|
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||
Product development related expenses |
|
|
13,156 |
|
|
|
13,702 |
|
Personnel related expenses |
|
|
4,491 |
|
|
|
3,696 |
|
General and administration related expenses |
|
|
1,385 |
|
|
|
749 |
|
Other payables |
|
|
935 |
|
|
|
51 |
|
Total |
|
|
19,967 |
|
|
|
18,198 |
|
Accrued general and administrative related expenses and other payables primarily increased due to professional services and transaction costs incurred during 2025 related to the November 2025 Offerings.
17. WARRANT LIABILITIES
The following table summarizes the Company’s outstanding warrant liabilities by warrant type as of December 31, 2025 and 2024:
|
2025 |
|
|
2024 |
|
||||||||||||||||||
|
BCA Warrants |
|
|
Amended BlackRock Warrant |
|
|
Total Warrant Liabilities |
|
|
BCA Warrants |
|
|
BlackRock Warrant |
|
|
Total Warrant Liabilities |
|
||||||
Balance as of January 1, |
|
19,390 |
|
|
|
461 |
|
|
|
19,851 |
|
|
|
5,370 |
|
|
|
- |
|
|
|
5,370 |
|
Issuance of warrants |
|
- |
|
|
|
122 |
|
|
|
122 |
|
|
|
- |
|
|
|
294 |
|
|
|
294 |
|
Fair value loss on warrant liability |
|
12,280 |
|
|
|
14 |
|
|
|
12,294 |
|
|
|
15,364 |
|
|
|
167 |
|
|
|
15,531 |
|
Exercise of public and private warrants |
|
(17,789 |
) |
|
|
- |
|
|
|
(17,789 |
) |
|
|
(1,344 |
) |
|
|
- |
|
|
|
(1,344 |
) |
Balance as of December 31, |
|
13,881 |
|
|
|
597 |
|
|
|
14,478 |
|
|
|
19,390 |
|
|
|
461 |
|
|
|
19,851 |
|
The fair value of the public BCA Warrants, which are traded on Nasdaq, is based on the quoted Nasdaq market prices at the end of the reporting period for such warrants. Since the private placement BCA Warrants have identical terms to the public BCA Warrants, the Company determined that the fair value of each private placement BCA Warrant is equivalent to that of each public BCA Warrant. The public BCA Warrants are included in Level 1 and the private placement BCA Warrants in Level 2 of the fair value hierarchy. The BCA Warrants are classified as short-term liabilities given that the Company cannot defer the settlement for at least 12 months.
The BlackRock Warrant, described in Note 5, is classified as a liability because its exercise price is fixed in USD, which is not the functional currency of the Company and therefore it does not meet the requirements to be classified as equity under IFRS. The fair value of the BlackRock Warrant is determined using the Black-Scholes option-pricing model and is included in Level 3 of the fair value hierarchy.
The following assumptions were used in the Black-Scholes option-pricing model for determining the fair value of the BlackRock Warrant as of initial issuance date, December 31, 2024, Amended BlackRock Warrant issuance date and December 31, 2025 as indicated:
110
|
|
December 31, 2025 |
|
|
July 31, 2025 |
|
|
December 31, 2024 |
|
|
May 29, 2024 |
|
||||
Share price on valuation date |
|
USD 19.97 (CHF 15.83) |
|
|
USD 17.64 (CHF 14.34) |
|
|
USD 17.00 (CHF 15.38) |
|
|
USD 11.93 (CHF 10.88) |
|
||||
Expected volatility (%) (1) |
|
82.52-85.13 |
|
|
|
88.53 |
|
|
|
94.32 |
|
|
|
85.56 |
|
|
Expected term (years) (2) |
|
2.71-3.29 |
|
|
|
3.50 |
|
|
|
3.21 |
|
|
|
3.50 |
|
|
Risk-free interest rate (%) (3) |
|
3.53-3.58 |
|
|
|
3.91 |
|
|
|
4.28 |
|
|
|
4.75 |
|
|
Dividend yield (%) |
|
|
0.00 |
|
|
|
0.00 |
|
|
|
0.00 |
|
|
|
0.00 |
|
(1) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.
(2) The expected term represents the period that the BlackRock Warrant is expected to be outstanding.
(4) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected terms.
For the year ended December 31, 2025, the Company recognized a fair value loss of CHF 12.3 million, primarily due to increase of the warrant share price. There were exercises of 1,929,467 warrant shares during the year ended December 31, 2025 at a price of CHF 9.55 or $11.50 per share, which resulted in a reduction of CHF 17.8 million to the warrant liability, an additional CHF 19.8 million of cash and an increase of CHF 37.8 million in shareholders’ equity. The warrant exercises, partially offset by the fair value loss resulted in a decrease of the warrant liability to CHF 14.5 million as of December 31, 2025. For the year ended December 31, 2024, the Company recognized a fair value loss of CHF 15.5 million, leading to an increase of the warrant liability to CHF 19.9 million as of December 31, 2024. The exercise of 279,033 public warrants at a price of CHF 10.13 or $11.50 per share during the year ended December 31, 2024 resulted in a reduction of CHF 1.3 million to the warrant liability, an additional CHF 2.7 million of cash and an increase of CHF 4.1 million in shareholders’ equity.
In the event of an exercise, warrant liabilities are reduced by the fair value on the date of exercise. The resulting fair value adjustment and cash received are recorded to share premium within the statements of changes in equity. The movement of the warrant liabilities during the years ended December 31, 2025 and 2024 is illustrated below:
|
|
2025 |
|
|
2024 |
|
||||||||||
|
|
Warrant liabilities |
|
|
Number of outstanding |
|
|
Warrant liabilities |
|
|
Number of outstanding warrants |
|
||||
Balance as of January 1, |
|
|
19,851 |
|
|
|
4,018,384 |
|
|
|
5,370 |
|
|
|
4,254,096 |
|
Issuance of warrants |
|
|
122 |
|
|
|
15,989 |
|
|
|
294 |
|
|
|
43,321 |
|
Fair value loss on warrant liability |
|
|
12,294 |
|
|
|
- |
|
|
|
15,531 |
|
|
|
- |
|
Exercise of public and private warrants |
|
|
(17,789 |
) |
|
|
(1,929,467 |
) |
|
|
(1,344 |
) |
|
|
(279,033 |
) |
Balance as of December 31, |
|
|
14,478 |
|
|
|
2,104,906 |
|
|
|
19,851 |
|
|
|
4,018,384 |
|
18. COMMITMENTS AND CONTINGENCIES
Commitments related to Novartis license agreement
In December 2018, Oculis entered into an agreement with Novartis, under which Oculis licensed a novel topical anti-TNFα antibody, now named as Licaminlimab, for ophthalmic indications. As consideration for the licenses, Oculis is obligated to pay non-refundable, upfront license fees, predefined development and commercial milestone payments and royalties on net sales of licensed products. Royalties range from high one digit to low teens, based on sales thresholds. As of December 31, 2019, Oculis had paid in full the contractual non-refundable upfront fee of CHF 4.7 million. Oculis has not reached any milestones or royalties thresholds according to the agreement. If all predefined milestones will be reached, Oculis will be obligated to pay additional CHF 76.9 million or $97.0 million. Royalties are based on net sales of licensed products, depending on the sales volumes reached.
Commitments related to Accure license agreement
On January 29, 2022, the Company entered into a License Agreement with Accure for the exclusive global licensing of its Privosegtor technology. Under this agreement, Oculis licensed a novel neuroprotective drug candidate, now renamed as Privosegtor, for ophthalmic and other indications (refer to Note 9). As consideration for the licenses, Oculis is obligated to pay non-refundable, upfront license fees, predefined development and commercial milestone payments and royalties on net sales of licensed products. Royalties range from one digit to low teens, based on sales thresholds. As of December 31, 2025, Oculis has paid the full contractual non-refundable upfront fee of CHF 3.0 million and reimbursed costs in the amount
111
of CHF 0.5 million. During the fourth quarter of 2024, the Company met the first two milestones pursuant to the agreement, which were FDA IND clearance for the intravenous formulation of Privosegtor, and completion and positive readout of the first PoC clinical trial for AON, resulting in an accrual of CHF 1.1 million, for which payment was made in 2025. If all remaining predefined milestones are reached, Oculis will be obligated to pay a total of CHF 87.9 million or $110.9 million. The next clinical and regulatory milestone under the Accure Agreement will trigger a payment of CHF 2.1 million ($2.6 million) that the Company expects to pay in 2026. In case of a commercialization, sublicense revenues will be subject to further royalty payments.
Commitments related to Rennes University Collaboration Research agreement
On January 31, 2022, the Company entered into a collaboration research agreement with the Rennes University and CNRS in France. This agreement is for the research of Antisense Oligonucleotide (ASO) to modulate gene expressions. As consideration for the research performed by Rennes University and CNRS, Oculis is obligated to pay a non-refundable cost contribution of CHF 0.2 million or EUR 0.2 million. As of December 31, 2025, Oculis paid a contractual non-refundable cost contribution of CHF 0.1 million or EUR 0.1 million. Following completion of the research services, the parties shall sign a commercial agreement based on predefined development and commercial milestone payments and royalties on net sales of licensed products as defined in the collaboration research agreement. Oculis has not reached any milestones or royalties thresholds. If the commercial agreement was signed by the parties and development and commercial milestones were reached, Oculis would be obligated to pay an additional CHF 6.5 million or EUR 7.0 million and royalties ranging from low to mid-single digit percentage on net sales. In case of sublicense revenues, Oculis shall be subject to further royalty payments.
Research and development commitments
The Group conducts product research and development programs through third party vendors that include, among others, arrangements with universities, contract research organizations and clinical research sites. Oculis has contractual arrangements with these organizations. As of December 31, 2025, commitments for external research and development projects amounted to CHF 42.0 million, compared to CHF 32.2 million as of December 31, 2024, as detailed in the schedule below. The increase in commitments year over year is primarily due to the progression of ongoing clinical trials during 2025, including the DIAMOND trials, as well as the initiation of the PIONEER program and PREDICT-1 trial in Q4 2025.
|
|
As of December 31, 2025 |
|
As of December 31, 2024 |
Within one year |
|
31,449 |
|
21,933 |
Between one and five years |
|
10,537 |
|
10,232 |
Total |
|
41,986 |
|
32,165 |
19. RELATED PARTY DISCLOSURES
Key management, including the Board of Directors and the executive management team, compensation expenses were:
|
|
For the years ended December 31, |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Salaries, cash compensation and other short-term benefits |
|
|
6,030 |
|
|
|
4,902 |
|
|
|
3,067 |
|
Pension expense |
|
|
498 |
|
|
|
398 |
|
|
|
320 |
|
Share-based compensation expense |
|
|
11,502 |
|
|
|
7,480 |
|
|
|
2,543 |
|
Total |
|
|
18,030 |
|
|
|
12,780 |
|
|
|
5,930 |
|
Salaries, cash compensation and other short-term benefits include social security, board member fees and insurance benefits.
The number of key management individuals reported as receiving compensation in the table above decreased from 12 to 11 for the year ended December 31, 2025 as compared to the year ended December 31, 2024. The number of individuals receiving compensation for service on the Board of Directors as reported in the table above was 4 for the years ended December 31, 2025 and 2024.
112
20. FINANCIAL INSTRUMENTS / RISK MANAGEMENT
Categories of financial instruments:
As indicated in Note 3, all financial assets and liabilities are shown at amortized cost, except for warrant liabilities that are held at fair value. The following table shows the carrying amounts of financial assets and liabilities:
|
|
|
|
|||||
Financial assets |
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||
Financial assets - non-current |
|
|
249 |
|
|
|
141 |
|
Other current assets, excluding prepaids |
|
|
801 |
|
|
|
148 |
|
Accrued income |
|
|
993 |
|
|
|
629 |
|
Short-term financial assets |
|
|
131,684 |
|
|
|
70,955 |
|
Cash and cash equivalents |
|
|
81,329 |
|
|
|
27,708 |
|
Total |
|
|
215,056 |
|
|
|
99,581 |
|
|
|
|
|
|||||
Financial liabilities |
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||
Trade payables |
|
|
1,800 |
|
|
|
5,871 |
|
Accrued expenses and other payables |
|
|
19,967 |
|
|
|
18,198 |
|
Lease liabilities |
|
|
2,313 |
|
|
|
1,180 |
|
Warrant liabilities |
|
|
14,478 |
|
|
|
19,851 |
|
Total |
|
|
38,558 |
|
|
|
45,100 |
|
Below is the net debt table of liabilities from financing activities:
|
|
Leasing |
|
|
Warrant liabilities |
|
|
Total |
|
|||
Net debt as of December 31, 2023 |
|
|
(605 |
) |
|
|
(5,370 |
) |
|
|
(5,975 |
) |
Payments for the period |
|
|
321 |
|
|
|
- |
|
|
|
321 |
|
Issuance of warrants |
|
|
- |
|
|
|
(294 |
) |
|
|
(294 |
) |
Fair value loss on warrant liability |
|
|
- |
|
|
|
(15,531 |
) |
|
|
(15,531 |
) |
Exercise of public and private warrants |
|
|
- |
|
|
|
1,344 |
|
|
|
1,344 |
|
Addition of Swiss lease |
|
|
(792 |
) |
|
|
- |
|
|
|
(792 |
) |
Interest calculated on leases |
|
|
(47 |
) |
|
|
- |
|
|
|
(47 |
) |
Indexation for the period |
|
|
(25 |
) |
|
|
- |
|
|
|
(25 |
) |
FX revaluation |
|
|
(32 |
) |
|
|
- |
|
|
|
(32 |
) |
Net debt as of December 31, 2024 |
|
|
(1,180 |
) |
|
|
(19,851 |
) |
|
|
(21,031 |
) |
Payments for the period |
|
|
460 |
|
|
|
- |
|
|
|
460 |
|
Issuance of warrants |
|
|
- |
|
|
|
(122 |
) |
|
|
(122 |
) |
Fair value loss on warrant liability |
|
|
- |
|
|
|
(12,294 |
) |
|
|
(12,294 |
) |
Exercise of public and private warrants |
|
|
- |
|
|
|
17,789 |
|
|
|
17,789 |
|
Addition of US and Iceland amended leases |
|
|
(1,530 |
) |
|
|
- |
|
|
|
(1,530 |
) |
Interest calculated on leases |
|
|
(87 |
) |
|
|
- |
|
|
|
(87 |
) |
Indexation for the period |
|
|
(20 |
) |
|
|
- |
|
|
|
(20 |
) |
FX revaluation |
|
|
44 |
|
|
|
- |
|
|
|
44 |
|
Net debt as of December 31, 2025 |
|
|
(2,313 |
) |
|
|
(14,478 |
) |
|
|
(16,791 |
) |
Fair values
Due to their short-term nature, the carrying value of cash and cash equivalents, short-term financial assets, other current assets, excluding prepaid expenses, accrued income, trade payables and accrued expenses and other payables approximates their fair value.
The warrant liabilities are measured at fair value on a recurring basis, refer to Note 3.
113
Risk assessment
The Company maintains an internal control system that includes an annual financial reporting risk assessment. The ultimate responsibility of the risk management is of the Board of Directors and a yearly review takes place during one of the Board of Directors meetings.
Market risk
Market risk is the risk that changes in market prices, such as foreign exchange rates, interest rates and equity prices will affect the Company’s income or the value of its holdings of financial instruments. The objective of market risk management is to manage and control market risk exposures within acceptable parameters, while optimizing the return.
As of December 31, 2025, if the listed price of the warrants had moved by 5.0% with all other variables held constant, the net loss for the period would have been lower/higher by CHF 0.7 million. As of December 31, 2024, the change would have been CHF 1.0 million.
Foreign currency risks
Since 2020, Oculis has established a presence in the U.S., France and Hong Kong with local currencies in U.S. Dollar (USD), Euro (EUR) and Hong Kong Dollar (HKD), respectively. In 2025, foreign currency risks primarily relate to cash and cash equivalents, short term financial assets, prepaid expenses, trade payables and accrued expenses denominated in U.S. Dollar and Euro, with immaterial amounts recorded in ISK and HKD.
The following table demonstrates the impact of a possible change in USD and EUR against CHF in regard to monetary assets and liabilities denominated in local functional currencies, as well as the impact of foreign currency risk on the Company’s consolidated net loss:
|
As of December 31, 2025 |
|
For the year ended December 31, 2025 |
|
|
As of December 31, 2024 |
|
For the year ended December 31, 2024 |
|
||||
Change in rate |
Net exposure |
|
Impact on loss |
|
|
Net exposure |
|
Impact on loss |
|
||||
+5.0% USD |
|
5,586 |
|
|
279 |
|
|
|
10,272 |
|
|
(514 |
) |
-5.0% USD |
|
5,586 |
|
|
(279 |
) |
|
|
10,272 |
|
|
514 |
|
+5.0% EUR |
|
3,951 |
|
|
198 |
|
|
|
5,409 |
|
|
270 |
|
-5.0% EUR |
|
3,951 |
|
|
(198 |
) |
|
|
5,409 |
|
|
(270 |
) |
Interest rate risk
The financial instruments of the Group are not bearing interest and are therefore not subject to interest rate risk.
Hedging activities
There are no hedging activities within the Group.
Credit risk
As of December 31, 2025, the maximum exposure is the carrying amount of the Company’s cash, cash equivalents and short-term financial assets are mainly held with two financial institutions, each with a high credit rating of A+ assigned by international credit-rating agencies. Management focuses on diversification strategies and monitors counterparties’ ratings to minimize exposure.
Liquidity risk
Liquidity risk is the risk that the Group will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. Liquidity management is performed by Group finance based on cash flow forecasts which are prepared on a rolling basis and focuses mainly on ensuring that the Group has sufficient cash to meet its operational needs. The Group’s liquidity needs have been historically satisfied through the issuance of preferred shares, the Business Combination, PIPE and CLA financings, and share offerings, discussed further in Note 5.
114
All of the Company’s financial instruments, except for the long-term portion of lease liabilities, are due within one year. The following table shows the total future obligations related to these financial instruments:
|
|
As of December 31, 2025 |
|
|
Less than one year |
|
|
Over |
|
|
As of December 31, 2024 |
|
|
Less than one year |
|
|
Over |
|
||||||
Trade payables |
|
|
1,800 |
|
|
|
1,800 |
|
|
|
- |
|
|
|
5,871 |
|
|
|
5,871 |
|
|
|
- |
|
Accrued expenses and other payables |
|
|
19,967 |
|
|
|
19,967 |
|
|
|
- |
|
|
|
18,198 |
|
|
|
18,198 |
|
|
|
- |
|
Lease payments |
|
|
2,931 |
|
|
|
551 |
|
|
|
2,380 |
|
|
|
1,270 |
|
|
|
353 |
|
|
|
917 |
|
Total |
|
|
24,698 |
|
|
|
22,318 |
|
|
|
2,380 |
|
|
|
25,339 |
|
|
|
24,422 |
|
|
|
917 |
|
Capital management
Since its incorporation, the Group has primarily funded its operations through capital increases, and at the current development stage, the Group frequently raises new funds to finance its development portfolio.
21. LOSS PER SHARE
As of December 31, 2025, the Company had 57,984,438 ordinary shares issued and outstanding with a share price of $19.97 or CHF 15.83. The following table sets forth the loss per share calculations for the years ended December 31, 2025, 2024 and 2023.
|
For the years ended December 31, |
|
|||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Net loss for the period attributable to Oculis shareholders |
|
(98,957 |
) |
|
|
(85,777 |
) |
|
|
(88,802 |
) |
Loss per share |
|
|
|
|
|
|
|
|
|||
Weighted-average number of shares used to compute basic and diluted loss per share |
|
52,243,100 |
|
|
|
40,406,551 |
|
|
|
29,899,651 |
|
|
|
|
|
|
|
|
|
|
|||
Basic and diluted net loss per share for the period, in CHF |
|
(1.89 |
) |
|
|
(2.12 |
) |
|
|
(2.97 |
) |
Since the Company has a loss for all periods presented, basic net loss per share is the same as diluted net loss per share. Potentially dilutive securities that were not included in the diluted loss per share calculations because they would be anti-dilutive were as follows:
|
As of December 31, |
|
|||||||||
|
2025 |
|
|
2024 |
|
|
2023 |
|
|||
Share options issued and outstanding |
|
4,946,948 |
|
|
|
4,444,388 |
|
|
|
3,096,473 |
|
Earnout options |
|
216,998 |
|
|
|
242,666 |
|
|
|
369,737 |
|
Share and earnout options issued and outstanding |
|
5,163,946 |
|
|
|
4,687,054 |
|
|
|
3,466,210 |
|
Restricted stock units subject to future vesting |
|
1,007,636 |
|
|
|
467,478 |
|
|
|
- |
|
Restricted shares subject to repurchase |
|
- |
|
|
|
- |
|
|
|
98,094 |
|
Unvested earnout shares |
|
948,549 |
|
|
|
2,371,272 |
|
|
|
3,793,995 |
|
Public warrants |
|
1,893,897 |
|
|
|
3,823,364 |
|
|
|
4,102,397 |
|
Private warrants |
|
151,699 |
|
|
|
151,699 |
|
|
|
151,699 |
|
BlackRock Warrant |
|
59,310 |
|
|
|
43,321 |
|
|
|
- |
|
Total |
|
9,225,037 |
|
|
|
11,544,188 |
|
|
|
11,612,395 |
|
22. SUBSEQUENT EVENTS
As a result of the BCA, Legacy Oculis equity holders received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01. The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post acquisition-closing VWAP targets of Oculis of $15.00, $20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period during the earnout period. In February 2026, the third price target of $25.00 was met, resulting in 55,487 earnout options becoming exercisable and the immediate vesting of 948,549 earnout shares.
115
Report of the Statutory Auditor to the General Meeting on the Financial Statements of Oculis Holding AG for the year ended December 31, 2025
116
|
|
Overall materiality |
CHF 5,200 thousand |
|
|
Benchmark applied |
Total assets |
|
|
Rationale for the materiality benchmark applied |
We chose total assets as the benchmark, because, in our view, it is the benchmark against which the performance of the Company, which has limited operating activities and which mainly holds investments in subsidiaries and intra-group loans, is most commonly measured, and it is a generally accepted benchmark for holding companies. |
|
|
We agreed with the Audit Committee that we would report to them misstatements above CHF 520 thousand identified during our audit as well as any misstatements below that amount which, in our view, warranted reporting for qualitative reasons.
Audit scope
We designed our audit by determining materiality and assessing the risks of material misstatement in the financial statements. In particular, we considered where subjective judgements were made; for example, in respect of significant accounting estimates that involved making assumptions and considering future events that are inherently uncertain. As in all of our audits, we also addressed the risk of management override of internal controls, including among other matters consideration of whether there was evidence of bias that represented a risk of material misstatement due to fraud.
We tailored the scope of our audit in order to perform sufficient work to enable us to provide an opinion on the financial statements as a whole, taking into account the structure of the Company, the accounting processes and controls, and the industry in which the Company operates.
Key audit matters
We have determined that there are no key audit matters to communicate in our report.
Other information
The Board of Directors is responsible for the other information. The other information comprises the information included in the annual report, which has partially been made available to us with the 6-K and 20-F filings, (but does not include the financial statements and the consolidated financial statements and our auditor’s reports thereon), which we obtained prior to the date of this auditor’s report, and the full annual report, which is expected to be made available to us after that date.
Our opinion on the financial statements does not cover the other information and we do not express any form of assurance conclusion thereon.
In connection with our audit of the financial statements, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the audit or otherwise appears to be materially misstated.
If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.
118
Board of Directors’ responsibilities for the financial statements
The Board of Directors is responsible for the preparation of financial statements in accordance with the provisions of Swiss law and the Company’s articles of incorporation, and for such internal control as the Board of Directors determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, the Board of Directors is responsible for assessing the Company’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the Board of Directors either intends to liquidate the Company or to cease operations, or has no realistic alternative but to do so.
Auditor’s responsibilities for the audit of the financial statements
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Swiss law and SA-CH will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
As part of an audit in accordance with Swiss law and SA-CH, we exercise professional judgement and maintain professional scepticism throughout the audit. We also:
We communicate with the Board of Directors or its relevant committee regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.
We also provide the Board of Directors or its relevant committee with a statement that we have complied with relevant ethical requirements regarding independence, and communicate with them regarding all
119
relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied.
From the matters communicated with the Board of Directors or its relevant committee, we determine those matters that were of most significance in the audit of the financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication.
Report on other legal and regulatory requirements
In accordance with article 728a para. 1 item 3 CO and PS-CH 890, we confirm the existence of an internal control system that has been designed, pursuant to the instructions of the Board of Directors, for the preparation of the financial statements.
Based on our audit according to article 728a para. 1 item 2 CO, we confirm that the Board of Directors' proposal complies with Swiss law and the Company’s articles of incorporation. We recommend that the financial statements submitted to you be approved.
PricewaterhouseCoopers SA
/s/ Alex Fuhrer |
/s/ Violina Eremciuc |
Licensed audit expert |
|
Auditor in charge |
|
Lausanne, March 4, 2026
120
Statutory Financial Statements of Oculis Holding AG for the year ended December 31, 2025
121
Oculis Holding AG, Zug
Table of Contents
FINANCIAL STATEMENTS |
|
Financial statements |
123 |
Notes to the statutory financial statements |
125 |
|
|
APPROPRIATION OF AVAILABLE EARNINGS |
|
Appropriation of available earnings and reserves of Oculis Holding AG |
134 |
122
Oculis Holding AG, Zug
Balance Sheet
(in CHF thousands)
|
|
|
As of December 31, |
|
|||||
Assets |
Note |
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
|
||
Cash and cash equivalents |
|
|
|
3,251 |
|
|
|
3,687 |
|
Other current receivables |
|
|
|
10,657 |
|
|
|
2,878 |
|
From third parties |
|
|
|
387 |
|
|
|
395 |
|
From group subsidiaries |
6 |
|
|
10,270 |
|
|
|
2,483 |
|
Prepaid expenses |
|
|
|
468 |
|
|
|
478 |
|
Total current assets |
|
|
|
14,376 |
|
|
|
7,043 |
|
|
|
|
|
|
|
|
|
||
Non-current assets |
|
|
|
|
|
|
|
||
Loans to group subsidiaries |
5 |
|
|
323,107 |
|
|
|
163,161 |
|
Other long-term receivables - From group subsidiaries |
6 |
|
|
— |
|
|
|
1,540 |
|
Investments |
7 |
|
|
191,067 |
|
|
|
191,067 |
|
|
|
|
|
|
|
|
|
||
Total non-current assets |
|
|
|
514,174 |
|
|
|
355,768 |
|
|
|
|
|
|
|
|
|
||
Total assets |
|
|
|
528,550 |
|
|
|
362,811 |
|
|
|
|
As of December 31, |
|
|||||
Liabilities and shareholders' equity |
Note |
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
|
||
Trade payables |
|
|
|
2,617 |
|
|
|
4,494 |
|
To third parties |
|
|
|
82 |
|
|
|
187 |
|
To group subsidiaries |
|
|
|
2,535 |
|
|
|
4,307 |
|
Other short-term liabilities |
|
|
|
1,831 |
|
|
|
12 |
|
Accrued expenses |
|
|
|
993 |
|
|
|
306 |
|
|
|
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
5,441 |
|
|
|
4,812 |
|
|
|
|
|
|
|
|
|
||
Shareholders' equity |
|
|
|
|
|
|
|
||
Share capital |
8 |
|
|
596 |
|
|
|
470 |
|
Statutory capital reserves |
|
|
|
602,767 |
|
|
|
404,116 |
|
Reserves from capital contribution |
|
|
|
492,464 |
|
|
|
293,879 |
|
Other statutory capital reserves |
|
|
|
110,303 |
|
|
|
110,237 |
|
Treasury shares held by Oculis Holding AG |
8 |
|
|
(7 |
) |
|
|
(10 |
) |
Accumulated deficit |
|
|
|
(46,577 |
) |
|
|
(41,398 |
) |
Loss of the period |
|
|
|
(33,670 |
) |
|
|
(5,179 |
) |
|
|
|
|
|
|
|
|
||
Total shareholders' equity |
|
|
|
523,109 |
|
|
|
357,999 |
|
|
|
|
|
|
|
|
|
||
Total liabilities and shareholders' equity |
|
|
|
528,550 |
|
|
|
362,811 |
|
The accompanying notes form an integral part of the financial statements.
123
Oculis Holding AG, Zug
Profit and loss statement
(in CHF thousands)
|
|
|
For the years ended December 31, |
|
||||
|
Note |
|
2025 |
|
2024 |
|
||
|
|
|
|
|
|
|
||
Operating income |
|
|
|
1,138 |
|
|
— |
|
Personnel expenses |
|
|
|
(2,724 |
) |
|
— |
|
Other operating expenses |
4. (A) |
|
|
(20,488 |
) |
|
(11,281 |
) |
Operating expenses |
|
|
|
(23,212 |
) |
|
(11,281 |
) |
|
|
|
|
|
|
|
||
Operating loss |
|
|
|
(22,074 |
) |
|
(11,281 |
) |
|
|
|
|
|
|
|
||
Financial income |
4. (B) |
|
|
7,584 |
|
|
6,113 |
|
Financial expense |
4. (B) |
|
|
(19,180 |
) |
|
(11 |
) |
|
|
|
|
|
|
|
||
Loss before taxes |
|
|
|
(33,670 |
) |
|
(5,179 |
) |
|
|
|
|
|
|
|
||
Direct taxes |
|
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
||
Loss of the period |
|
|
|
(33,670 |
) |
|
(5,179 |
) |
The accompanying notes form an integral part of the financial statements.
124
Oculis Holding AG, Zug
NOTES TO THE STATUTORY FINANCIAL STATEMENTS
(All amounts presented in CHF thousands, except share numbers, unless otherwise noted)
1. GENERAL INFORMATION
Oculis Holding AG (the “Company” or “Oculis”) is a stock corporation (Aktiengesellschaft) with its registered office at Bahnhofstrasse 20, CH-6300, Zug, Switzerland. It was incorporated under the laws of Switzerland in accordance with article 620 et seq. of the Swiss Code of Obligations (“CO”) and registered as of October 31, 2022.
As of December 31, 2025, the Company controls a wholly-owned subsidiary Oculis Operations Sàrl (“Oculis Operations”). Oculis Operations has a registered office in Lausanne, Switzerland, which was incorporated in Zug, Switzerland on December 27, 2022, and has six wholly-owned subsidiaries:
Oculis is a global late clinical-stage biopharmaceutical company with substantial expertise in therapeutics for the treatment of ophthalmic and neuro-ophthalmic diseases. Oculis is engaged in developing innovative drug candidates with the potential to address significant unmet medical needs for many eye-related and neuro-ophthalmic conditions. The Company's mission is to save sight and improve eye care for patients worldwide and it intends to become a global leader in ophthalmic and neuro-ophthalmic therapeutics to realize this mission. The purpose of the Company is the research, study, development, manufacture, promotion, sale and marketing of biopharmaceutical products and substances as well as the purchase, sale and exploitation of intellectual property rights, such as patents and licenses, in the field of ophthalmology. Oculis’ pipeline product candidates in clinical development include: OCS-01, a topical eye drop candidate for diabetic macular edema (“DME”); Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (“DED”); and Privosegtor (OCS-05), a neuroprotective candidate for optic neuritis (“ON”), non-arteritic anterior ischemic optic neuropathy (“NAION”) with broad potential for other neuro-ophthalmic diseases.
2. SIGNIFICANT EVENTS IN THE CURRENT REPORTING PERIOD
Public Offerings of Ordinary Shares
February 2025 Offering
In February 2025, the Company closed an underwritten follow-on offering of 5,000,000 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.00 (CHF 18.05) per share, for total gross proceeds of $100.0 million (CHF 90.2 million). New shares were issued out of the Company’s existing capital band.
November 2025 Offerings
On November 3, 2025, the Company closed offerings of an aggregate of 5,432,098 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.25 (CHF 16.33) per share for total gross proceeds of $110.0 million (CHF 88.7 million), before deducting underwriting discounts and commissions and offering expenses. The Company issued 2,635,801 shares out of the Company’s existing capital band and transferred to offering participants 2,796,297 shares previously held in treasury by the Company.
Loan Facility
On July 31, 2025, the Company entered into an amended and restated agreement for its existing loan facility (the “Amended Loan Agreement”) with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by Blackrock, Inc. The Amended Loan Agreement replaces the prior loan agreement between the Company and the Lender
125
dated May 29, 2024, with an upsized structure to provide the EUR equivalent of up to CHF 75.0 million in borrowing capacity (which may be increased to up to CHF 100.0 million) (the “Loan”), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 25.0 million each, as well as an additional loan of the EUR equivalent of up to CHF 25.0 million, which may be made available by the Lender to the Company if mutually agreed in writing by the Lender and the Company. No amounts were drawn under the Amended Loan Agreement during the year ended December 31, 2025. Pursuant to the Amended Loan Agreement, the Company is subject to a non-utilization fee of 0.75% per annum of any undrawn amount under tranches 1 and 2. Additionally, to the extent Loan 1 has not been drawn prior to its expiry date, an additional one-time fee of the EUR equivalent of CHF 2.6 million shall be payable, subject to certain conditions.
As additional consideration for the Loan, Kreos Capital VII Aggregator SCSp, an affiliate of the Lender (the “Holder”) and the Company entered into an amended warrant (the “Amended Blackrock Warrant”) to purchase up to 494,259 of the Company’s ordinary shares, subject to vesting, at a price per ordinary share equal to $12.17 (CHF 9.65) with respect to 361,011 shares from the prior warrant agreement, and $18.64 (CHF 14.78) with respect to the remaining 133,248 shares reflecting the upsized facility, subject to adjustment. The Amended Blackrock Warrant amends the prior warrant issued to Holder on May 29, 2024. As of the signing date, the Amended Blackrock Warrant is exercisable for 59,310 ordinary shares, of which 43,321 shares were previously granted. Following the drawdown of each of Loans 1, 2 and 3, the Amended Blackrock Warrant will become exercisable for additional amounts of ordinary shares ratably based on the amounts of Loans 1, 2 and 3 that are drawn. Each tranche of the Amended Blackrock Warrant in connection with Loans 1, 2 and 3, will be exercisable for a period of up to seven years from the date of vesting and the Amended Blackrock Warrant will terminate at the earliest of (i) December 31, 2033, (ii) such earlier date on which the Amended Blackrock Warrant is no longer exercisable for any warrant shares in accordance with its terms and (iii) the acceptance by the shareholders of the Company of a third-party bona fide offer for all outstanding shares of the Company (subject to any prior exercise by the Holder, if applicable). The Amended Blackrock Warrant had not been exercised in part or in full as of December 31, 2025. The Blackrock Warrant had not been exercised in part or in full as of December 31, 2025.
At-the-Market Offering Program
On May 8, 2024, the Company entered into a sales agreement with Leerink Partners, LLC (“Leerink Partners”) with respect to an at-the-market offering program (the “ATM Offering Program”) under which the Company may offer and sell, from time to time at its sole discretion, ordinary shares of the Company having an aggregate offering price of up to $100.0 million (CHF 79.3 million) through Leerink Partners as its sales agent. Any such sales, made through the sales agent, can be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, or in other transactions pursuant to an effective shelf registration statement on Form F-3. The Company agreed to pay Leerink Partners a commission of up to 3.0% of the gross proceeds of any sales of ordinary shares sold pursuant to the sales agreement. Following the execution of the agreement, the Company issued 1,000,000 ordinary shares during the year ended December 31, 2024 and 2,500,000 ordinary shares during the year ended December 31, 2025 out of its existing capital band, each with a nominal value of CHF 0.01 to be held as treasury shares.
On October 29, 2025, in conjunction with the November 2025 Underwritten Offering, the Company suspended the ATM Offering Program. The sales agreement with Leerink Partners remains in full force and effect. As of October 29, 2025, we had not sold any ordinary shares under the ATM Offering Program. Of the ordinary shares held as treasury shares, 2,796,297 were issued in connection with the November 2025 Offerings discussed below.
Registered Direct Offering and Nasdaq Iceland Main Market Listing
On April 22, 2024, the Company closed its registered direct offering with gross proceeds of CHF 53.5 million or $58.8 million through the issuance and sale of 5,000,000 of its ordinary shares, nominal value CHF 0.01 per share, at a purchase price of CHF 10.70 or $11.75 per share to investors (the “Registered Direct Offering”), and commenced trading of its ordinary shares on the Nasdaq Iceland Main Market under the ticker symbol “OCS” on April 23, 2024.
Business Combination with European Biotech Acquisition Corp (“EBAC”)
On March 2, 2023, the Company consummated a business combination with EBAC (the “Business Combination”) pursuant to the Business Combination Agreement (“BCA”) between Oculis SA (“Legacy Oculis”) and EBAC dated as of October 17, 2022. The Company received gross proceeds of CHF 97.6 million or $103.7 million comprising CHF 12.0 million or $12.8 million of cash held in EBAC’s trust account and CHF 85.6 million or $90.9 million from private placement (“PIPE”) investments and conversion of notes issued under Convertible Loan Agreements (“CLA”) into Oculis' ordinary shares. In connection with the Business Combination, Oculis was listed on the Nasdaq Global Market with the ticker symbol “OCS” for its ordinary shares and “OCSAW” for its public warrants.
126
3. BASIS OF PREPARATION AND ACCOUNTING POLICIES
Basis of preparation
The statutory Financial Statements of Oculis, with registered office in Zug, Switzerland, were prepared according to the principles of the Swiss Law on Accounting and Financial Reporting (32nd title of the Swiss Code of Obligations). Where not prescribed by law, the significant accounting and valuation principles applied are described below.
Oculis is presenting its Consolidated Financial Statements according to IFRS (“IFRS Accounting Standards”). As a result, Oculis has applied the exemption included in art. 961d of the Swiss Code of Obligations and has not included additional disclosures and a cash flow statement in its Statutory Financial Statements.
Going concern
Oculis accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances, as well as government research and development grants. The recent Registered Direct Offering and listing on the NASDAQ Iceland Main Market in April 2024, as well as the February and November 2025 follow-on offerings discussed in Note 2 raised funding to secure business continuity. The Board of Directors believes that cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund the Group’s operations and capital expenditure requirements for at least the next 12 months.
Cash and cash equivalents
Cash and cash equivalents are valued at nominal value.
Investments
Investments are initially recognized at cost, assessed annually for impairment triggers, and adjusted to their recoverable amount as needed.
Loans to group subsidiaries
Short and long term loans to Oculis Group subsidiaries are valued at nominal value under consideration of any impairment if needed.
Foreign currency
The Company's books are expressed in Swiss Francs (CHF). During the year, transactions denominated in foreign currencies are converted into Swiss Francs at the rate in effect at the transaction date. At year-end, assets and liabilities denominated in foreign currencies are converted into Swiss Francs using the year-end exchange rates. Realized and unrealized exchange gains and losses are recorded net as financial income or financial expenses.
Warrants
Liabilities related to warrants are recorded at nominal value. Given warrants have no nominal or intrinsic value, these are not recognized in the statutory Financial Statements. The exercise of warrants by their holders does not lead to any cash outflows from the Company.
Earnout consideration
In accordance with the BCA (note 2), Legacy Oculis preferred, ordinary and option holders (collectively “equity holders”) received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01. The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post-acquisition volume weighted average share price targets (“VWAP”) of Oculis of CHF 11.89 or $15.00, CHF 15.86 or $20.00 and CHF 19.82 or $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028. A given share price target described above will also be deemed to be achieved if there is a change of control transaction, as defined in the BCA.
The earnout shares have been registered in the Registry of Commerce of the Canton of Zug and are included in the number of outstanding shares as of December 31, 2025. The earnout shares are recorded at nominal value. Upon meeting the criteria, Oculis would not further increase its reserve from capital contribution. The price targets of $15.00 or CHF 11.89,
127
$20.00 or CHF 15.86 and $25.00 or CHF 19.82 were met in November 2024, February 2025 and February 2026, respectively, resulting in an aggregate of 2,845,446 earnout shares vested and 159,453 earnout options outstanding and exercisable as of December 31, 2025, and an additional 948,549 earnout shares vested and 55,487 earnout options becoming exercisable in February 2026.
4. INCOME AND EXPENSES
(A) OTHER OPERATING EXPENSES
For the year ended December 31, 2025, the Company recorded CHF 20.5 million of other operating expenses, as compared to CHF 11.3 million for the year ended December 31, 2024. The increase is primarily related to professional fees incurred related to the February 2025 and November 2025 Offerings.
(B) FINANCIAL INCOME AND EXPENSE
Foreign exchange gain / (losses) reported into financial income and expenses are presented net per currency.
|
|
For the Year Ended December 31, 2025 |
|
|
For the Year Ended December 31, 2024 |
|
||||||||||
|
|
Income |
|
|
Expenses |
|
|
Income |
|
|
Expenses |
|
||||
Interest |
|
|
7,426 |
|
|
|
(156 |
) |
|
|
3,961 |
|
|
|
— |
|
Net foreign exchange gain / (loss) |
|
|
158 |
|
|
|
(19,024 |
) |
|
|
2,152 |
|
|
|
(11 |
) |
Total |
|
|
7,584 |
|
|
|
(19,180 |
) |
|
|
6,113 |
|
|
|
(11 |
) |
For the years ended December 31, 2025 and 2024, the Company had approximately CHF 7.4 million and CHF 4.0 million, respectively, of interest income from the intercompany loan, as described in Notes 6 and 7. For the year ended December 31, 2025, the foreign currency exchange loss of CHF 19.0 million is primarily related to overall weakening of the U.S. dollar against the Swiss Franc on intra-group loans denominated in U.S. dollars.
5. LOAN TO GROUP SUBSIDIARIES
The following table presents the intra-group loan between Oculis and its subsidiary Oculis Operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Original Borrower |
|
Start date |
|
Repayment |
|
USD |
|
|
EUR |
|
|
CHF |
|
|
Total CHF |
|
||||
As of December 31, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Oculis Operations Sàrl |
|
March, 2023 |
|
December, 2027 |
|
|
173,656 |
|
|
|
7,836 |
|
|
|
178,143 |
|
|
|
323,107 |
|
As of December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Oculis Operations Sàrl |
|
March, 2023 |
|
December, 2027 |
|
|
49,322 |
|
|
|
8,695 |
|
|
|
110,350 |
|
|
|
163,161 |
|
These loans were made to support the Group's clinical and business development activities and bear interest using the rate published by the Swiss federal Tax Administration for CHF, USD and Euro denominated loans to shareholders and intercompany entities.
6. OTHER RECEIVABLES
As of December 31, 2025, the Company had other current receivables of CHF 10.7 million, compared to CHF 2.9 million as of December 31, 2024. The increase is primarily related to higher loan interest on both USD and CHF loans due to higher loan balances, refer to Note 5.
As of December 31, 2024, the Company had recognized accrued income from the intercompany loan interest (as described in Note 5). The interest had not been billed to the Oculis Operations subsidiary as it related to the CHF 146.0 million subordinated portion of the intercompany loan at December 31, 2024, as per the subordination agreement then in effect signed between both entities. As of December 31, 2025 no subordination was in effect, and accordingly no interest income was accrued on the intercompany loan.
128
|
|
As of December 31, 2025 |
|
|
As of December 31, 2024 |
|
||
|
|
|
|
|
|
|
||
Accrued interest on intercompany loan |
|
|
— |
|
|
|
1,540 |
|
7. INVESTMENTS
As of December 31, 2025, the Company had seven direct and indirect subsidiaries. As of December 31, 2024, the Company had five direct and indirect subsidiaries as Neurocol IP Sàrl and Neurocol Operations Sàrl were incorporated in December 2025. The following table describes the principal subsidiaries, the countries of incorporation and the percentage of ownership and voting interest held by the Company.
|
|
|
|
Share in Capital |
|
|
||
Company |
|
Domicile |
|
% of capital and vote |
|
Direct/indirect |
|
Main activities |
Oculis Operations Sàrl |
|
Switzerland |
|
100% |
|
Direct |
|
Research, business and clinical development |
Oculis ehf |
|
Iceland |
|
100% |
|
Indirect |
|
Research, business and clinical development |
Oculis France Sàrl |
|
France |
|
100% |
|
Indirect |
|
Research, business and clinical development |
Oculis US Inc |
|
USA |
|
100% |
|
Indirect |
|
Business and clinical development |
Oculis HK, Limited |
|
Hong Kong |
|
100% |
|
Indirect |
|
Business and clinical development |
Neurocol IP Sàrl |
|
Switzerland |
|
100% |
|
Indirect |
|
Holding of intellectual property rights |
Neurocol Operations Sàrl |
|
Switzerland |
|
100% |
|
Indirect |
|
Research, business and clinical development |
8. SHARE CAPITAL AND TREASURY SHARES
Share capital and treasury shares
As of December 31, 2025, the Company had a share capital of CHF 0.6 million. The Company's share capital consists of 59,636,690 shares with a nominal value of CHF 0.01.
|
|
Shares |
|
|
Share capital |
|
|
Treasury Shares |
|
|
Treasury share capital |
|
||||
December 31, 2023 |
|
|
40,443,700 |
|
|
|
404 |
|
|
|
— |
|
|
|
— |
|
Registered Direct Offering |
|
|
5,000,000 |
|
|
|
50 |
|
|
|
— |
|
|
|
— |
|
Shares issued to treasury under the ATM program |
|
|
1,000,000 |
|
|
|
10 |
|
|
|
(1,000,000 |
) |
|
|
(10 |
) |
Shares issued for vesting of Restricted Shares Units |
|
|
9,430 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Shares issued for exercise of options |
|
|
301,511 |
|
|
|
3 |
|
|
|
— |
|
|
|
— |
|
Shares issued for exercise of warrants |
|
|
279,033 |
|
|
|
3 |
|
|
|
— |
|
|
|
— |
|
December 31, 2024 |
|
|
47,033,674 |
|
|
|
470 |
|
|
|
(1,000,000 |
) |
|
|
(10 |
) |
Registered Direct Offering |
|
|
7,635,801 |
|
|
|
76 |
|
|
|
2,796,297 |
|
|
|
28 |
|
Shares issued to treasury under the ATM program |
|
|
2,500,000 |
|
|
|
25 |
|
|
|
(2,500,000 |
) |
|
|
(25 |
) |
Shares issued for vesting of Restricted Shares Units |
|
|
174,655 |
|
|
|
2 |
|
|
|
— |
|
|
|
— |
|
Shares issued for exercise of options |
|
|
363,093 |
|
|
|
4 |
|
|
|
— |
|
|
|
— |
|
Shares issued for exercise of warrants |
|
|
1,929,467 |
|
|
|
19 |
|
|
|
— |
|
|
|
— |
|
December 31, 2025 |
|
|
59,636,690 |
|
|
|
596 |
|
|
|
(703,703 |
) |
|
|
(7 |
) |
February 2025 Offering
In February 2025, the Company closed an underwritten follow-on offering of 5,000,000 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.00 (CHF 18.05) per share, for total gross proceeds of $100.0 million (CHF 90.2 million). New shares were issued out of the Company’s existing capital band.
November 2025 Offerings
On November 3, 2025, the Company closed offerings of an aggregate of 5,432,098 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.25 (CHF 16.33) per share for total gross proceeds of $110.0 million (CHF 88.7 million),
129
before deducting underwriting discounts and commissions and offering expenses. The Company issued 2,635,801 shares out of the Company’s existing capital band and transferred to offering participants 2,796,297 shares previously held in treasury by the Company.
Registered Direct Offering
On April 22, 2024, the Company closed its Registered Direct Offering with gross proceeds of CHF 53.5 million or $58.8 million through the issuance and sale of 5,000,000 of our ordinary shares, at a purchase price of CHF 10.70 or $11.75 per share to investors. This capital increase was made using the capital band.
ATM program
On May 8, 2024, the Company entered into the ATM Program under which the Company may offer and sell, from time to time at its sole discretion, ordinary shares of the Company having an aggregate offering price of up to $100.0 million (CHF 79.3 million) through Leerink Partners as its sales agent. Following the execution of the agreement, the Company issued 1,000,000 ordinary shares out of its existing capital band, each with a nominal value of CHF 0.01 to be held as treasury shares. On October 29, 2025, in conjunction with the November 2025 Offerings, the Company suspended the ATM Offering Program. The sales agreement with Leerink Partners remains in full force and effect.
Earnout shares
As a result of the BCA, Legacy Oculis “equity holders” received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01. The price targets of $15.00 or CHF 11.89, $20.00 or CHF 15.86 and $25.00 or CHF 19.82 were met in November 2024, February 2025 and February 2026, respectively, resulting in an aggregate of 2,845,446 earnout shares vested and 159,453 earnout options outstanding and exercisable as of December 31, 2025, and an additional 948,549 earnout shares vested and 55,487 earnout options becoming exercisable in February 2026.
Reserves from capital contribution
As of December 31, 2025, the reserves from capital contribution amounted to CHF 492.5 million. Of this amount, CHF 255.3 million has not yet been confirmed by the Swiss Federal Tax administration for purposes of recognition as reserves from capital contributions in accordance with art. 20 para. 3 of the Federal Act on Direct Federal Taxation.
Capital band
As of December 31, 2025, the Company has a capital band between CHF 545,336.74 (lower limit) and CHF 818,005.11 (upper limit). The Company may effect an increase of the Company’s share capital in a maximum amount of CHF 272,668.37 by issuing up to 27,266,837 ordinary shares with a par value of CHF 0.01 each out of the Company’s capital band, of which 2,635,801 ordinary shares with a par value of CHF 0.01 each have been used in the November 2025 Offerings. The Board of Directors is authorized to increase the share capital up to the upper limit or decrease the share capital up to the lower limit at any time and as often as required until June 4, 2030.
Conditional share capital
The conditional capital at December 31, 2025 amounts to a maximum of CHF 235,752.08 split into 23,575,208 ordinary shares, in connection with the potential future issuances of:
CHF 67,500.00 through the issuance of a maximum of 6,750,000 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of convertible rights and/or option rights or warrants, new bonds and similar debt instruments.
130
CHF 124,800.00 through the issuance of a maximum of 12,480,000 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of option rights or other equity-linked instruments granted to any employee, consultant or member of the Board of Directors of the Group.
During the year ended December 31, 2025, 363,093 stock options have been exercised and 174,655 RSUs vested resulting in the associated ordinary shares issued using the conditional share capital for employee benefit plans. These shares have not been registered yet in the commercial register as of December 31, 2025.
CHF 39,751.05 through the issuance of a maximum of 3,975,105 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of warrants.
During the year ended December 31, 2025, 1,929,467 warrants were exercised and the associated ordinary shares have been issued using the conditional share capital for BCA public and private warrants. These shares have not been registered yet in the commercial register as of December 31, 2025.
CHF 3,701.03 through the issuance of a maximum of 370,103 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of option rights or other equity-linked instruments granted to any employee, consultant or member of the Board of Directors of the Group. As of December 31, 2025, 159,453 earnout options were exercisable.
Treasury shares
In connection with the ATM Offering Program, the Company issued a total of 1,000,000 ordinary shares during the year ended December 31, 2024 and 2,500,000 ordinary shares during the year ended December 31, 2025, each with a nominal value of CHF 0.01 to be held as treasury shares. There were no sales under the ATM Offering Program during the year ended December 31, 2025. In connection with the November 2025 Offerings, the Company transferred to offering participants 2,796,297 of the shares previously issued and held in treasury by the Company.
9. DECLARATION OF FULL TIME EQUIVALENT EMPLOYEES
The Company had three employees during the year ended December 31, 2025 and no employees during the year ended December 31, 2024.
10. WARRANTS
Public and Private Warrants
Pursuant to the BCA and the Warrant Assignment and Assumption Agreement executed in connection with the BCA, described in Note 2, the Company has assumed 4,251,595 BCA public warrants and 151,699 BCA private warrants from EBAC, and issued 4,403,294 warrants as of March 2, 2023 with substantially the same terms. Each warrant entitles the registered holder to purchase one ordinary share at a price of CHF 9.55 or $11.50 per share, subject to certain adjustments, exercisable at any time commencing 30 days after the acquisition closing date, provided that the Company has an effective registration statement under the Securities Act covering the issuance of the ordinary shares issuable upon exercise of the warrants. This registration statement was filed with the SEC and declared effective on May 1, 2023. The warrants will expire on March 2, 2028.
Blackrock Warrants
As additional consideration for the Loan, Kreos Capital VII Aggregator SCSp, an affiliate of Kreos Capital VII (UK) Limited, which are funds and accounts managed by Blackrock, Inc. and the Company entered into an amended warrant to purchase up to 494,259 of the Company’s ordinary shares, subject to vesting, at a price per ordinary share equal to $12.17 (CHF 9.65) with respect to 361,011 shares from the prior warrant agreement, and $18.64 (CHF 14.78) with respect to the remaining 133,248 shares reflecting the upsized facility, subject to adjustment. The Amended Blackrock Warrant amends the prior warrant issued to Holder on May 29, 2024. As of the signing date, the Amended Blackrock Warrant is exercisable for 59,310 ordinary shares, of which 43,321 shares were previously granted. Following the drawdown of each of Loans 1, 2 and 3, the Amended Blackrock Warrant will become exercisable for additional amounts of ordinary shares ratably based on the amounts of Loans 1, 2 and 3 that are drawn. Each tranche of the Amended Blackrock Warrant in connection with
131
Loans 1, 2 and 3, will be exercisable for a period of up to seven years from the date of vesting and the Amended Blackrock Warrant will terminate at the earliest of (i) December 31, 2033, (ii) such earlier date on which the Amended Blackrock Warrant is no longer exercisable for any warrant shares in accordance with its terms and (iii) the acceptance by the shareholders of the Company of a third-party bona fide offer for all outstanding shares of the Company (subject to any prior exercise by the Holder, if applicable). The Amended Blackrock Warrant had not been exercised in part or in full as of December 31, 2025.
The movement of the number of outstanding warrants is illustrated below:
|
|
|
|
Number of outstanding warrants |
|
|
Balance as of December 31, 2023 |
|
|
4,254,096 |
|
||
Issuance of Blackrock warrants |
|
|
43,321 |
|
||
Exercise of public and private warrants |
|
|
(279,033 |
) |
||
Balance as of December 31, 2024 |
|
|
4,018,384 |
|
||
Issuance of Blackrock warrants |
|
|
15,989 |
|
||
Exercise of public and private warrants |
|
|
(1,929,467 |
) |
||
Balance as of December 31, 2025 |
|
|
2,104,906 |
|
||
11. SHARES AND OPTIONS ON SHARES GRANTED TO EXECUTIVE OFFICERS, DIRECTORS AND EMPLOYEES
The following table presents information on the allocation of shares and equity awards to executive officers, directors and employees in accordance with Article 959c, paragraph 2, number 11 of the Swiss Code of Obligations (CO) during the periods January 1, 2024 through December 31, 2024 and January 1, 2025 through December 31, 2025.
Shares and earnout shares values are based on the Company's closing share price of USD 19.97 (CHF 15.83) and USD 17.00 (CHF 15.38) as of December 31, 2025 and December 31, 2024, respectively. Options, restricted stock units (“RSUs”), stock appreciation rights (“SARs”) and earnout options are recognized at fair value at grant date. The fair value of the Company's options, SARs and earnout options is determined using the Black-Scholes Model. The fair value of RSUs is equal to the closing share price on the date of grant.
The following table summarizes equity award activity for the year ended December 31, 2025:
|
|
|
|
Options / RSUs |
|
|||||
|
|
|
|
Number |
|
|
Fair value in CHF |
|
||
|
|
|
|
|
|
|
|
|
||
Issued to executive officers and directors |
|
|
763,258 |
|
|
|
10,853 |
|
||
Issued to employees |
|
|
1,053,750 |
|
|
|
12,695 |
|
||
Issued to consultants of the Company |
|
|
124,936 |
|
|
|
1,881 |
|
||
Total other equity compensation |
|
|
1,941,944 |
|
|
|
25,429 |
|
||
The following table summarizes equity award activity for the year ended December 31, 2024:
|
|
|
|
Options / RSUs |
|
|
|||||
|
|
|
|
Number |
|
|
Fair value in CHF |
|
|
||
|
|
|
|
|
|
|
|
|
|
||
Issued to executive officers and directors |
|
|
799,721 |
|
|
|
6,694 |
|
|
||
Issued to employees |
|
|
1,349,309 |
|
|
|
10,444 |
|
|
||
Issued to consultants of the Company |
|
|
139,000 |
|
|
|
1,146 |
|
|
||
Total other equity compensation |
|
|
2,288,030 |
|
|
|
18,284 |
|
|
||
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12. CONTINGENT LIABILITIES
The Company has no contingent liabilities as of December 31, 2025 and 2024.
13. SUBSEQUENT EVENTS AFTER THE BALANCE SHEET DATE
As a result of the BCA, Legacy Oculis equity holders received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01. The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post acquisition-closing VWAP targets of Oculis of $15.00 or CHF 11.89, $20.00 or CHF 15.86 and $25.00 or CHF 19.82, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period during the earnout period. In February 2026, the third price target of $25.00 or CHF 19.82 was met, resulting in 55,487 earnout options becoming exercisable and the immediate vesting of 948,549 earnout shares.
133
Appropriation of available earnings and reserves of Oculis Holding AG
|
|
|
|
|
|
|
||
|
|
For the year ended |
|
|
For the year ended |
|
||
Accumulated losses carried forward |
|
|
|
|
|
|
||
Balance at the beginning of the period |
|
|
(46,577 |
) |
|
|
(41,398 |
) |
Loss of the year |
|
|
(33,670 |
) |
|
|
(5,179 |
) |
Loss available to the ordinary general meeting |
|
|
(80,247 |
) |
|
|
(46,577 |
) |
|
|
|
|
|
|
|
||
|
|
December 31, |
|
|||||
Motion of the Board of Directors on the proposed carry forward of the accumulation of losses |
|
2025 |
|
|
2024 |
|
||
Accumulated losses available to the general meeting |
|
|
(80,247 |
) |
|
|
(46,577 |
) |
Balance to be carried forward |
|
|
(80,247 |
) |
|
|
(46,577 |
) |
134
Report of the Statutory Auditor to the General Meeting on the Compensation Report 2025
135
Compensation Report 2025 of Oculis Holding AG
139
Compensation Report 2025
to the Shareholders’ Meeting of Oculis Holding AG
This compensation report (the “Compensation Report”) of Oculis Holding AG (the “Company”) has been prepared in accordance with the Swiss Code of Obligations (“SCO”). Unless otherwise indicated or the context otherwise requires, all references in the Compensation Report to the “Company”, “we”, “our”, “us” or similar terms refer to the Company and its consolidated subsidiaries.
Principles of the Compensation of the Board of Directors and the Executive Committee
Pursuant to Swiss law, the aggregate amount of compensation of the board of directors of the Company (the “Board of Directors”) and the persons whom the Board of Directors has entrusted with the management of the Company (the “Executive Committee”) shall be submitted to the annual general meeting of shareholders of the Company (the “AGM”) for a binding vote.
In the Compensation Report, the aggregate amounts of compensation, loans, and other forms of indebtedness to the Board of Directors and the Executive Committee respectively are disclosed, as well as the specific amount for each member of the Board of Directors and for the highest-paid member of the Executive Committee, specifying the name and function of each of these persons.
As a Swiss company listed on the United States Nasdaq Global Market and Nasdaq Iceland Main Market, we are prohibited from granting certain forms of compensation to members of the Board of Directors and the Executive Committee, such as:
Compensation to members of the Board of Directors and the Executive Committee for activities in Subsidiaries is prohibited, if (i) the compensation would be prohibited if it was paid directly by the Company, (ii) the Articles do not provide for it, or (iii) the compensation has not been approved by the AGM.
Each year, at the AGM, shareholders will vote on the proposals of the Board of Directors with respect to:
The Board of Directors may submit for approval to the AGM deviating, additional or conditional proposals relating to the maximum aggregate amount or maximum partial amounts for the same or different periods or specific compensation components.
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If the AGM does not approve a proposal of the Board of Directors, the Board of Directors shall determine, considering all relevant factors, the respective (maximum) aggregate amount or (maximum) partial amounts, and submit the amount(s) so determined for approval to a new AGM or an extraordinary general meeting of shareholders of the Company for a binding vote.
The Company or Subsidiaries, on a go-forward basis, may pay or grant compensation prior to approval by the AGM, subject to subsequent approval.
Members of the Board of Directors may be paid in fixed basic remuneration, fixed committee fee for work in committee(s) of the Board of Directors and in equity instruments of the Company. Members of the Executive Committee may be paid fixed remuneration payable in cash and equity compensation, and variable remuneration in the form of a performance-related remuneration payable in cash and shares or equity-linked instruments in the Company, depending on the continued service to the Company and performance of the Company as well as the individual. Performance is measured based on the achievement of pre-determined targets in a given year. The Board of Directors determines annually at the beginning of each calendar year the decisive targets and their weighting upon proposal by the remuneration committee of the Board of Directors (the “Remuneration Committee”).
Compensation may be paid or granted in the form of cash, shares, options, or other equity-linked instruments. The Board of Directors, upon proposal of the Remuneration Committee, allocates to the members of the Executive Committee and the Board of Directors a fixed number of shares, options or other equity-linked instruments and the Board of Directors or, to the extent delegated to it, the Remuneration Committee shall determine grant, vesting, exercise, and forfeiture conditions. Granting equity to non-executive directors, although less common in Switzerland, is in line with practice for companies listed on Nasdaq and such awards are not granted subject to performance conditions.
Method of Determining Compensation
Role and Powers of the Remuneration Committee
The Remuneration Committee consists of more than two members, who will be elected/re-elected at the AGM for a period until the following AGM. The Board of Directors appoints the chair of the Remuneration Committee and fills any vacancies until the following AGM. The Remuneration Committee is composed entirely of independent directors.
The Remuneration Committee supports our Board of Directors in establishing and reviewing the compensation and benefits strategy and guidelines as well as in preparing the proposals to the AGM regarding the compensation of the members of the Board of Directors and the Executive Committee. The Remuneration Committee may submit proposals to the Board of Directors on other compensation-related matters.
The Remuneration Committee has the responsibility to, among other things:
141
Compensation of the Board of Directors
As per the Articles, the compensation of the non-executive members of the Board of Directors is comprised of the following elements: a fixed basic remuneration, a fixed committee fee for service in a committee of the Board of Directors and a number of options, shares or other equity-linked instruments in the Company. The total compensation shall take into account the position and level of responsibility of the relevant member of the Board of Directors.
As per the Articles, compensation may be paid in the form of cash, shares, options or other equity-linked instruments. The Board of Directors or, to the extent delegated to it, the Remuneration Committee, shall determine grant, vesting, exercise and forfeiture conditions. In particular, it may provide for continuation, acceleration, or removal of vesting, exercise and forfeiture conditions, for payment or grant of compensation based upon assumed target achievement, or for forfeiture, in each case in the event of pre-determined events such as a change-of-control or termination of an employment or mandate agreement.
Compensation of the Members of the Executive Committee
As per the Articles, the compensation of the members of the Executive Committee may consist of fixed and variable compensation elements. Fixed compensation comprises a fixed remuneration payable in cash. Variable compensation comprises a performance-related remuneration which depends on the Company's business success and Executive Committee individual’s performance or achievement of pre-determined targets during a calendar or fiscal year. Total compensation takes into account the position and level of responsibility of the recipient.
As per the Articles, compensation may be paid in the form of cash, shares, options, or other equity-linked instruments. Short-term compensation is in the form of base salary and target bonus, which are cash based, whereas long-term compensation is equity based. The Board of Directors or, to the extent delegated to it, the Remuneration Committee, determines the grants of equity. The Stock Option and Incentive Plan Regulation 2023 (the “2023 Plan”) provides that a participant may only exercise an option or stock appreciation right to the extent that the option or stock appreciation right has vested and has not lapsed under the 2023 Plan. Unless otherwise determined by our Board of Directors at the grant date or as set forth in the grant notice, an option or an award in the form of a restricted stock unit or stock appreciation right granted under the 2023 Plan typically vests as to 25% of the award at the end of the first year following the vesting start date, with the remaining 75% of the award vesting either monthly or quarterly over the 3 years after the first year following the vesting start date, depending on award type. Any restricted stock may not be transferred or pledged. Such restriction expires with vesting or with the expiration of any repurchase right for the restricted stock. The 2023 Plan provides provisions that govern the exercise of any awards held by the participant at the time the legal relationship forming the basis of the service is coming to an end. Generally, any award not vested shall immediately lapse at the time a notice of termination has been received (regardless of which party gives notice) or at the end of the term in case of a board member. If indicated in the grant notice or otherwise resolved
142
by the Board of Directors, upon the occurrence of a “Corporate Transaction” (as defined in the 2023 Plan), all options and awards in the form of restricted stock units or stock appreciation rights (i) shall fully vest and (ii) in the case of options and stock appreciation rights must be immediately exercised, except if such options or stock appreciation rights are repurchased by the Company or a third party designated by the Company for a cash consideration equivalent to the economic value applicable to such option or stock appreciation right under the 2023 Plan.
Share Ownership Guidelines
Our Board of Directors adopted share ownership guidelines in May 2025 that are designed to promote the ongoing alignment of the Board of Directors and Executive Committee with the interests of our shareholders and to further promote our commitment to sound corporate governance. These guidelines require non-employee directors and members of the Executive Committee to own a certain amount of our shares by the end of a five-year compliance period and then annually thereafter. Pursuant to the guidelines, each non-employee director must own an amount of ordinary shares equal in value to three times the amount of their annual Board of Directors membership fee (exclusive of committee or chair fees), and each member of the Executive Committee must own an amount of ordinary shares equal in value to three times the amount of their annual base salary. For our Chief Executive Officer, this amount is five times the amount of his annual base salary.
Elements of Compensation for 2025
We believe that our overall compensation packages for members of the Executive Committee are market-competitive, given the importance of attracting, motivating, and retaining persons with the necessary skills, expertise and character. For 2025, the overall compensation consisted of base salary, cash bonus and equity incentive awards under the 2023 Plan.
Base Salary
We believe that our base salaries are in line with market practice. The base salary levels are based on the experience, skills, knowledge and responsibilities required for the relevant positions. Base salary and cash bonus are reviewed annually by the Remuneration Committee, taking into account individual responsibilities, performance and experience, as well as the results of the external benchmarking. The Remuneration Committee reviews and recommends for approval by the Board of Directors the annual base salary of the Chief Executive Officer, and, in consultation with the Chief Executive Officer, of the other members of the Executive Committee.
Bonus
The members of the Executive Committee are entitled to annual cash bonuses for their performance over the fiscal year, based on goals established by our Board of Directors. Annual cash bonuses may be earned by members of our Executive Committee based on achievement of individual performance objectives, and Company performance objectives which are approved by the Board of Directors each year. The bonus program is intended to strengthen the connection between individual compensation and Company success, reinforce our pay-for-performance philosophy by awarding higher bonuses to higher performing executives and help ensure that our compensation is competitive. Under the terms of the performance bonus program, the Remuneration Committee reviews and recommends for approval by the Board of Directors the annual cash bonus of the Chief Executive Officer, and, in consultation with the Chief Executive Officer, of the other members of the Executive Committee, based on the achieved objectives. The objectives reflect a robust set of qualitative and quantitative measures designed to drive Company strategy and secure the future of the Company (including, in 2025, consideration of share price performance against the Nasdaq Biotechnology Index (NBI) and performance against the Company financing plan), develop the Company portfolio and ensure that the Company is positioned for sustained growth.
Each member of the Executive Committee is eligible to receive an annual cash bonus under the program calculated by multiplying its base salary by a target percentage value assigned to it or to its position by the Remuneration Committee and the Board of Directors. The target percentage is a blended percentage based on individual and business performance. The business target percentage value is capped at 120%. The Remuneration Committee recommends for approval by the Board of Directors whether the annual cash bonus for each Executive Committee member is to be paid at target, under target or above target. Under certain circumstances, new members of the Executive Committee may receive replacement awards to compensate them for amounts forgone in connection with their change of employment.
143
Stock Option and Incentive Plan Regulation
In connection with the Company’s United States Nasdaq listing in March 2023, the Company adopted the 2023 Plan which was amended in May 2024. The 2023 Plan provides for the grant of options and other equity-linked awards including restricted stock awards, restricted stock units and stock appreciation rights. The purpose of the 2023 Plan is to attract and retain highly qualified personnel and to provide employees, non-employee directors and consultants with long-term incentive to perform at the highest level on behalf of and in the best interest of the Company and its Subsidiaries. The 2023 Plan is the sole means for the Company to grant equity incentive awards.
Plan Administration. The Plan is administered by a plan administrator (one or several persons) elected by our Board of Directors from time to time. Currently, our plan administrator is the full Board of Directors. The plan administrator is authorized to, among others, (i) determine the eligible persons who may receive equity awards under the 2023 Plan, (ii) determine the allocation of awards to all eligible participants, (iii) determine the exercise price and the term of each equity award within the parameters set forth in the 2023 Plan, and (iv) establish such rules and regulations deemed to be appropriate and proper for the administration of the 2023 Plan, in each case, subject to the guidelines set and approved by our Board of Directors or the Remuneration Committee.
Eligible Participants. Persons eligible to participate in our 2023 Plan are members of our Board of Directors, and employees and consultants of the Company and its Subsidiaries. The plan administrator determines within the guidelines set and approved by our Board of Directors or Remuneration Committee which eligible persons are to receive rights to acquire shares under the 2023 Plan.
Awards. Equity incentive awards under the 2023 Plan may be granted in the form of options, restricted stock awards or rights, either in the form of restricted stock units (RSU) or in the form of stock appreciation rights (SAR) (“Award(s)”). Awards reserved and available for grant and issuance pursuant to the 2023 Plan allow for the issuance of up to 12,480,000 registered shares. Awards, if granted, have an exercise price determined by the plan administrator within the guidelines set and approved by the Board of Directors or the Remuneration Committee. For options, the exercise price becomes immediately due upon exercise of the option and shall be payable to the Company. For SARs, the exercise price shall be deducted from the contractual claim of the eligible participant. Awards are not subject to individual limits but are granted at market appropriate levels.
Vesting. The vesting conditions for Awards pursuant the 2023 Plan are set forth in the applicable grant notices. Vesting may accelerate upon the occurrence of a “Corporate Transaction” (as defined in the 2023 Plan) if indicated in the grant notice or otherwise resolved by the Board of Directors. Unless otherwise determined by our Board of Directors at the grant date or set forth in the grant notice, excluding grants to non-employee Directors, Awards granted under the 2023 Plan generally vest as to 25% of the Award at the end of the first year following the vesting start date, with the remaining 75% of the Award vesting monthly (in the case of options) or quarterly (in the case of RSUs) ratably over the 3 years after the first year following the vesting start date. The exercise price for options granted is set equal to the fair market value on the date of grant. Initial awards granted to newly appointed members of the Board of Directors generally vest monthly (in the case of options) or quarterly (in the case of RSUs) ratably over the 3 years following the grant date. Annual awards granted to members of the Board of Directors vest over 1 year, becoming fully vested on the date of the following year's AGM.
Earnout consideration. On March 2, 2023, Oculis SA consummated a business combination ("Business Combination") pursuant to the Business Combination Agreement ("BCA") between Oculis SA and European Biotech Acquisition Corp ("EBAC") dated as of October 17, 2022. As a result of the BCA, Oculis SA preferred, ordinary and option holders received consideration in the form of 3,793,995 earnout shares in the Company and 369,737 earnout options in the Company with an exercise price of CHF 0.01.
The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of volume-weighted average share price (VWAP) targets of Oculis of $15.00, $20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028 (the “Earnout Period”). A given share price target described above will also be deemed to be achieved if there is a change of control, as defined in the BCA, transaction of Oculis during the Earnout Period. In November 2024, February 2025 and February 2026, the $15.00, $20.00 and $25.00 VWAP earnout price targets were met, respectively.
In relation to the shares and equity awards disclosed below, any earnout options and unvested earnout shares have not been included in Section 2.c. (Board Compensation Amounts) and Section 3.c. (Executive Committee Compensation
144
Amounts). Earnout options and earnout shares are specifically tied to the Business Combination and are thus excluded from consideration as compensation. However, earnout options have been included in Section 4. (Equity and Equity-Linked Instruments Held by Members of the Board of Directors and the Executive Committee).
Termination of Service and Corporate Transaction
Generally, in the event of a participant’s termination of service, any Award not vested upon receipt of a notice of termination of the relevant legal relationship shall immediately lapse. Any option exercisable at the time a notice of termination has been received (regardless of which party gives notice) and outstanding at the time the legal relationship forming the basis of the service ends shall remain exercisable within three months post-termination of the service relationship unless the plan administrator provides for an exemption, provided that such period shall in no event end later than the original expiry date of the option. Should the participant's service be terminated for cause, then all outstanding Awards (whether vested or not), held by the participant shall terminate immediately and cease to be outstanding.
If indicated in the grant notice or otherwise resolved by the Board of Directors, in the event of any Corporate Transaction (as defined in the 2023 Plan), all Awards (i) shall fully vest and (ii) in the case of options and SARs must be immediately exercised, except if such Awards are repurchased by the Company or a third party designated by the Company for a cash consideration equivalent to the economic value applicable to such Award under the 2023 Plan. If indicated in the grant notice, in the event of any Corporate Transaction, the repurchase right for any restricted stock shall expire and such restricted stock shall become unrestricted shares. At the consummation of the Corporate Transaction, all vested Awards shall be exercised and/or settled and shall cease to be outstanding. The Company shall be entitled to terminate any unvested Awards and thereby shall compensate a participant for the economic value of such Awards.
Amendment. The Board of Directors shall have complete and exclusive power and authority to amend or modify the 2023 Plan in any or all respects. Unless such change is required to comply with applicable law, listing requirements, accounting rules or tax requirements, no such amendment or modification shall, without the consent of the concerned participant, adversely affect its rights and obligations under the 2023 Plan.
Pensions and other post-employment benefit plans
We maintain post-employment benefit plans that provide our employees with an opportunity to save for retirement on a tax advantaged basis. The Company’s Swiss entity is affiliated to a collective foundation administrating the pension plans of various unrelated employers. In addition, a customary Swiss pension plan is in place for eligible employees, in compliance with the requirements of applicable laws. The Company’s Icelandic entity makes contributions to pension funds selected by our employees according to applicable laws. For the Company’s U.S. entity, we have adopted a 401(k) defined contribution plan.
Social Charges
The Company pays social security contributions as required by applicable law. The Company also pays certain non-mandatory benefits under local social security plans.
Employment Agreements
We have entered into employment agreements with all the members of our Executive Committee. Each of these agreements provides for a base salary and annual cash bonus opportunity, equity eligibility participation, as well as participation in certain pension and welfare benefit plans. These agreements generally require advance notice of termination, and in some cases provide for garden leave (paid leave). Members of our Executive Committee have agreed to covenants not to compete against us or solicit our employees or customers during and post-employment for a specified period following termination. We may be required to pay some members of our Executive Committee compensation for their covenant not to compete with us following termination for some period.
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Our Board of Directors is composed of eight members (each a “Director”). Each Director is elected for a one-year term. The current Directors were elected at our AGM on June 4, 2025 to serve until our 2026 AGM.
As a foreign private issuer, the Company is subject to the rules of the SEC and the Nasdaq Stock Exchange for its listing on the United States Nasdaq Global Market and to the regulations of the Financial Supervisory Authority of the Central Bank of Iceland (FME) for its listing on Nasdaq Iceland Main Market. We rely on Swiss home country governance requirements and certain exemptions thereunder rather than on the Nasdaq corporate governance requirements. The majority of our Directors are independent directors. There are no family relationships among any members of our Board of Directors or the Executive Committee.
Board of Directors
Name |
Role(s) |
Year Appointed |
Christina Ackermann |
Director |
2023 |
Lionel Carnot |
Director |
2023 |
Pravin Dugel, M.D.(1) |
Director |
2023 |
Arshad M. Khanani, M.D.(2) |
Director |
2024 |
Martijn Kleijwegt |
Director |
2023 |
Geraldine O’Keeffe |
Director |
2023 |
Anthony Rosenberg |
Chairperson of the Board of Directors |
2023 |
Riad Sherif, M.D. |
Director and Chief Executive Officer |
2022 |
Robert Warner(3) |
Director |
2024 |
(1) Pravin Dugel, M.D. retired from the Board of Directors on May 29, 2024.
(2) Arshad M. Khanani, M.D. was elected to the Board of Directors on May 29, 2024.
(3) Robert K. Warner was elected to the Board of Directors on May 29, 2024.
Board Committees
The composition of Board committees of the Board of Directors (“Board Committee(s)”) from May 29, 2024 and as of December 31, 2025 is as follows:
Name |
Audit |
Remuneration |
Nomination and Governance Committee |
Christina Ackermann |
Member |
Chairperson |
- |
Lionel Carnot |
Chairperson |
Member |
- |
Martijn Kleijwegt |
- |
- |
Member |
Geraldine O’Keeffe |
Member |
- |
Member |
Robert Warner |
- |
Member |
Chairperson |
The composition of Board Committees as of January 1, 2024 and through May 29, 2024 was as follows:
Name |
Audit |
Remuneration |
Nomination and Governance Committee |
Christina Ackermann |
Member |
Chairperson |
- |
Lionel Carnot |
Chairperson |
Member |
- |
Pravin Dugel, M.D. |
- |
Member |
Chairperson |
Martijn Kleijwegt |
- |
- |
Member |
Geraldine O'Keeffe |
Member |
- |
Member |
Members of the Board of Directors who are not employees of the Company (including any of its affiliates) (“Eligible Director”) are paid an annual retainer reflecting the specific role and responsibility as well as the expected average time involved with the function. Such annual retainers have been established in line with market practice and represent the fee paid for being a member of the Board of Directors or Board Committee and the additional fee paid to the chair of the Board of Directors or Board Committee.
146
The following amounts were approved in USD by the Board of Directors and are within the maximum compensation amounts approved by shareholders at the 2025 Annual General Meeting. Amounts were converted to CHF at the average USD/CHF rate in 2025 of 0.83066:
(amounts in thousands) |
Chair |
Member |
Board of Directors |
$89.0 (CHF 73.9) |
$48.0 (CHF 39.9) |
Audit Committee |
$20.0 (CHF 16.6) |
$12.0 (CHF 10.0) |
Remuneration Committee |
$15.0 (CHF 12.5) |
$7.5 (CHF 6.2) |
Nomination and Governance Committee |
$11.0 (CHF 9.1) |
$5.5 (CHF 4.6) |
In addition to the fixed compensation described above, each Eligible Director is eligible to participate in the 2023 Plan, subject to its terms and conditions as approved and amended by the Board of Directors from time to time. Upon election, the Company issues to Eligible Directors a one-time equity incentive Award under the 2023 Plan or other equity incentive plans then in effect, at an estimated equity value of USD 400,000 (CHF 332,264) in 2025, as compared to USD 270,000 (CHF 237,751) in 2024. The one-time equity incentive Award of Eligible Directors upon election is typically subject to a quarterly vesting of three years. The exact number of Awards to be granted is determined by the Company in the grant notice in its free discretion and only such grant notice has legal effect. The Company will also issue to Eligible Directors for any subsequent year an annual equity incentive award in the form of stock option or similar awards under the 2023 Plan or other equity incentive plans then in effect, at an estimated equity value of USD 250,000 (CHF 207,665) in 2025 subject to a quarterly vesting of approximately one year, with 100% vesting to occur on the date of the following year's AGM, as compared to USD 135,000 (CHF 118,876) in 2024. Above amounts exclude any applicable social charges.
The Eligible Directors are not eligible to any benefits other than those set out in the Board of Directors Compensation Philosophy, unless our Board of Directors decides otherwise. The Company reimburses all reasonable expenses in accordance with the terms and conditions of the Company’s travel and expense policy then in effect.
From January 1, 2025 through December 31, 2025, the compensation of the members of the Board of Directors for their service on the Board was as follows (converted from other currencies as applicable at the average prevailing exchange rate over the reporting period):
Amounts in CHF(1)
Name |
Role |
Gross cash compensation |
Employer social contributions(2) |
Total cash |
Equity FMV (3) |
Total compensation |
Christina Ackermann |
Director |
61,881 |
- |
61,880 |
205,275 |
267,155 |
Lionel Carnot(4) |
Director |
- |
- |
- |
- |
- |
Arshad Khanani, M.D.(6) |
Director |
39,745 |
- |
39,745 |
436,537 |
476,283 |
Martijn Kleijwegt(4) |
Director |
- |
- |
- |
- |
- |
Geraldine O’Keeffe(4) |
Director |
- |
- |
- |
- |
- |
Anthony Rosenberg |
Chairperson of the Board of Directors |
78,124 |
6,773 |
84,897 |
205,275 |
290,172 |
Riad Sherif, M.D.(5) |
Director and Chief Executive Officer |
- |
- |
- |
- |
- |
Robert Warner |
Director |
54,880 |
- |
54,880 |
205,275 |
260,155 |
Total |
|
234,630 |
6,773 |
241,402 |
1,052,362 |
1,293,764 |
(1) The Equity FMV amounts in USD were converted to CHF at the USD/CHF rate at grant date.
(2) Includes social security contributions as required by applicable laws for the year ended December 31, 2025.
(3) Amounts represent the aggregate grant date fair value of stock options granted to our non-employee Directors during 2025 at the date of grant, computed in accordance with IFRS 2. Assumptions used in the calculation of these amounts are included in Note 13 to our financial statements included in our Annual Report on Form 20-F for the year ended December 31, 2025. These amounts do not necessarily correspond to the actual value that may be recognized by the non-employee Directors. This equity FMV excludes social contributions that will be reported at the time when equity awards are exercised or vested.
(4) Lionel Carnot, Martijn Kleijwegt and Geraldine O’Keeffe did not receive any compensation for their services on the Board of Directors due to policy requirements of their employers which are investors in the Company.
(5) As a member of the Executive Committee, Riad Sherif, M.D. does not receive any compensation for service on the Board of Directors. Compensation for Riad Sherif, M.D. is included in Section 3.c below.
(6) Does not include CHF 49,840 of consulting fees paid for non-Board related services.
From January 1, 2024 through December 31, 2024, the compensation of the members of the Board of Directors for their service on the Board was as follows (converted from other currencies as applicable at the average prevailing exchange rate over the reporting period):
147
Amounts in CHF(1)
Name |
Role |
Gross cash compensation |
|
Employer social contributions(2) |
|
Total cash |
|
Equity FMV (3) |
|
Total compensation |
|
|||||
Christina Ackermann |
Director |
|
67,730 |
|
|
6,051 |
|
|
73,781 |
|
|
114,333 |
|
|
188,114 |
|
Lionel Carnot(5) |
Director |
- |
|
- |
|
|
- |
|
- |
|
|
- |
|
|||
Pravin Dugel, M.D. |
Director |
|
24,690 |
|
|
2,206 |
|
|
26,896 |
|
- |
|
|
26,896 |
|
|
Arshad Khanani, M.D.(4) |
Director |
|
78,855 |
|
|
2,300 |
|
|
81,155 |
|
|
507,237 |
|
|
588,391 |
|
Martijn Kleijwegt(5) |
Director |
- |
|
- |
|
|
- |
|
- |
|
|
- |
|
|||
Geraldine O’Keeffe(5) |
Director |
- |
|
- |
|
|
- |
|
- |
|
|
- |
|
|||
Anthony Rosenberg |
Chairperson of the Board of Directors |
|
80,341 |
|
|
4,217 |
|
|
84,558 |
|
|
118,871 |
|
|
203,429 |
|
Riad Sherif, M.D.(6) |
Director and Chief Executive Officer |
- |
|
- |
|
|
- |
|
- |
|
|
- |
|
|||
Robert Warner(4) |
Director |
|
35,394 |
|
|
3,162 |
|
|
38,556 |
|
|
227,856 |
|
|
266,412 |
|
Total |
|
|
287,010 |
|
|
17,936 |
|
|
304,945 |
|
|
968,297 |
|
|
1,273,242 |
|
(1) The Equity FMV amounts in USD were converted to CHF at the USD/CHF rate at grant date.
(2) Includes social security contributions as required by applicable laws for the year ended December 31, 2024.
(3) Amounts represent the aggregate grant date fair value of stock options granted to our non-employee Directors for the year ended December 31, 2024 at the date of grant, computed in accordance with IFRS 2. Assumptions used in the calculation of these amounts are included in Note 13 to our financial statements included in our Annual Report on Form 20-F for the year ended December 31, 2024. These amounts do not necessarily correspond to the actual value recognized or that may be recognized by the non-employee Directors. This equity FMV excludes social contributions that will be reported at the time when equity awards are exercised or vested.
(4) Robert Warner and Arshad Khanani, M.D. received a one-time equity incentive award upon joining the Board in May 2024.
(5) Lionel Carnot, Martijn Kleijwegt and Geraldine O’Keeffe did not receive any compensation for their services on the Board of Directors due to policy requirements of their employers which are investors in the Company.
(6) As a member of the Executive Committee, Riad Sherif, M.D. does not receive any compensation for service on the Board of Directors. Compensation for Riad Sherif, M.D. is included in Section 3.c below.
No loans were extended to members of the Board of Directors or outstanding during the period from January 1, 2025 through December 31, 2025 and during the period from January 1, 2024 through December 31, 2024. No payments to former members of the Board of Directors in connection with their former role or that are not at arm’s length were made during and with respect to such period, and no severance payments to any member or former member of the Board of Directors were made during and with respect to such period in accordance with the SCO. No payments to related parties of members of the Board of Directors were made during such period.
As of December 31, 2025 and December 31, 2024, our Executive Committee consisted of the following three members:
Name |
Position |
Riad Sherif, M.D. |
Chief Executive Officer and Director |
Sylvia Cheung |
Chief Financial Officer |
Páll Ragnar Jóhannesson |
Chief Business Officer |
Members of the Executive Committee receive compensation consisting of a base salary, annual cash bonus, social benefits and equity incentive awards granted under the 2023 Plan, as well as certain other benefits.
From January 1, 2025 through December 31, 2025, the fixed and variable compensation earned by the members of the Executive Committee was as follows (amounts in CHF converted from other currencies as applicable at the average prevailing exchange rate over the reporting period):
148
Name and Position |
Salary |
|
Bonus(1) |
|
Post-retirement benefit plans (employer)(2) |
|
Employer social contributions(3) |
|
Total cash |
|
Equity FMV(4) |
|
||||||
Riad Sherif, M.D. |
|
561,138 |
|
|
389,747 |
|
|
170,795 |
|
|
93,082 |
|
|
1,214,762 |
|
|
6,702,464 |
|
Total Executive Committee Compensation |
|
1,316,991 |
|
|
746,704 |
|
|
247,046 |
|
|
223,282 |
|
|
2,534,024 |
|
|
10,470,702 |
|
(1) Includes the earned or accrued bonus included in our financial statements for the year ended December 31, 2025, payable in 2026. The quantum of the accrued bonus reflects anticipated achievement of the robust set of qualitative and quantitative measures designed to drive Company strategy and secure the future of the Company (including consideration of share price performance against the Nasdaq Biotechnology Index and performance against the Company financing plan), advance the Company portfolio including clinical and regulatory milestones for OCS-01, Licaminlimab and Privosegtor, and ensure that the Company is positioned for sustained growth.
(2) Includes Company contributions to benefit plans and life insurance premiums for the year ended December 31, 2025.
(3) Includes social security contributions as required by applicable laws for the year ended December 31, 2025.
(4) Amounts represent the aggregate grant date fair value of stock options granted to our Executive Committee members during 2025 at the date of grant, computed in accordance with IFRS 2. Assumptions used in the calculation of these amounts are included in Note 13 to our financial statements included in our Annual Report on Form 20-F for the year ended December 31, 2025. These amounts do not necessarily correspond to the actual value recognized or that may be recognized by the Executive Committee members. This equity FMV excludes social contributions that will be reported at the time when equity awards are exercised.
From January 1, 2024 through December 31, 2024, the fixed and variable compensation earned by the members of the Executive Committee was as follows (amounts in CHF converted from other currencies as applicable at the average prevailing exchange rate over the reporting period):
Name and Position |
Salary |
|
Bonus(1) |
|
Post-retirement benefit plans (employer)(2) |
|
Employer social contributions(3) |
|
Total cash |
|
Equity FMV(4) |
|
||||||
Riad Sherif, M.D. |
|
537,500 |
|
|
330,000 |
|
|
145,545 |
|
|
89,232 |
|
|
1,102,277 |
|
|
3,868,083 |
|
Total Executive Committee Compensation |
|
1,260,096 |
|
|
628,681 |
|
|
215,806 |
|
|
216,729 |
|
|
2,321,312 |
|
|
5,995,529 |
|
(1) Includes the earned or accrued bonus included in our financial statements for the year ended December 31, 2024, payable in 2025. The quantum of the accrued bonus reflects anticipated achievement of the robust set of qualitative and quantitative measures designed to drive Company strategy and secure the future of the Company (including consideration of share price performance against the Nasdaq Biotechnology Index and performance against the Company financing plan), develop the Company portfolio and ensure that the Company is positioned for sustained growth.
(2) Includes Company contributions to benefit plans and life insurance premiums for the year ended December 31, 2024.
(3) Includes social security contributions as required by applicable laws for the year ended December 31, 2024.
(4) Amounts represent the aggregate grant date fair value of stock options granted to our Executive Committee members during 2024 at the date of grant, computed in accordance with IFRS 2. Assumptions used in the calculation of these amounts are included in Note 13 to our financial statements included in our Annual Report on Form 20-F for the year ended December 31, 2024. These amounts do not necessarily correspond to the actual value recognized or that may be recognized by the Executive Committee members. This equity FMV excludes social contributions that will be reported at the time when equity awards are exercised.
No loans were extended to members of the Executive Committee or were outstanding during the period from January 1, 2025 through December 31, 2025 and during the period from January 1, 2024 through December 31, 2024. No payments to former members of the Executive Committee in connection with their former role or that are not at arm's length were made during and with respect to such period, and no severance payments to members of the Executive Committee or former members of the Executive Committee were made during and with respect to such period in accordance with the SCO. No payments to related parties of members of the Executive Committee were made during such period.
Equity and Equity-Linked Instruments Held by Members of the Board of Directors
The members of the Board of Directors and their related parties, if any, held the following equity and equity-linked instruments as of December 31, 2025:
149
Name(1) |
Role |
Ordinary shares(2) |
|
Earnout shares(3) |
|
Option / SARs |
|
Earnout option shares (5) |
|
Restricted stock units |
|
Vested award |
|
||||||
Christina Ackermann |
Director |
|
6,528 |
|
- |
|
|
60,196 |
|
- |
|
|
6,526 |
|
|
63,749 |
|
||
Lionel Carnot |
Director |
|
90,753 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
|||||
Arshad M. Khanani, M.D. |
Director |
|
20,344 |
|
|
- |
|
|
38,574 |
|
|
1,798 |
|
|
39,278 |
|
|
24,066 |
|
Martijn Kleijwegt |
Director |
|
470,969 |
|
- |
|
- |
|
- |
|
|
- |
|
- |
|
||||
Geraldine O’Keeffe |
Director |
|
20,593 |
|
- |
|
- |
|
- |
|
|
- |
|
- |
|
||||
Anthony Rosenberg |
Chairperson of the Board of Directors |
|
129,720 |
|
|
5,070 |
|
|
33,491 |
|
|
879 |
|
|
6,526 |
|
|
34,803 |
|
Robert Warner |
Director |
|
6,528 |
|
|
- |
|
|
29,043 |
|
|
- |
|
|
6,526 |
|
|
14,521 |
|
Total |
|
|
745,435 |
|
|
5,070 |
|
|
161,304 |
|
|
2,677 |
|
|
58,856 |
|
|
137,139 |
|
(1) Excludes Riad Sherif, M.D. whose holdings are listed in the Executive Committee table.
(2) Aggregate number of share ownership at December 31, 2025.
(3) Aggregate number of unvested earnout share awards outstanding at December 31, 2025.
(4) Aggregate number of option/SARs awards outstanding at December 31, 2025.
(5) Aggregate number of earnout option awards outstanding at December 31, 2025.
(6) Equity securities this Director had the right to acquire, or to acquire “voting power” and/or “investment power”, as of December 31, 2025.
The members of the Board of Directors and their related parties, if any, held the following equity and equity-linked instruments as of December 31, 2024:
Name(1) |
Role |
Ordinary shares(2) |
|
Earnout shares(3) |
|
Option / SARs |
|
Earnout option shares(5) |
|
Restricted stock units |
|
Vested award |
|
||||||
Christina Ackermann |
Director |
- |
|
- |
|
|
67,656 |
|
- |
|
|
- |
|
|
40,663 |
|
|||
Lionel Carnot |
Director |
|
58,253 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
|||||
Arshad M. Khanani, M.D. |
Director |
|
3,772 |
|
|
- |
|
|
38,574 |
|
|
1,798 |
|
|
28,860 |
|
|
10,746 |
|
Martijn Kleijwegt |
Director |
|
470,969 |
|
- |
|
- |
|
- |
|
|
- |
|
- |
|
||||
Geraldine O’Keeffe |
Director |
|
20,593 |
|
- |
|
- |
|
- |
|
|
- |
|
- |
|
||||
Anthony Rosenberg |
Chairperson of the Board of Directors |
|
109,931 |
|
|
12,673 |
|
|
33,491 |
|
|
879 |
|
|
5,658 |
|
|
32,510 |
|
Robert Warner |
Director |
|
- |
|
|
- |
|
|
29,043 |
|
|
- |
|
|
- |
|
|
4,841 |
|
Total |
|
|
663,518 |
|
|
12,673 |
|
|
168,764 |
|
|
2,677 |
|
|
34,518 |
|
|
88,760 |
|
(1) Excludes Riad Sherif, M.D. whose holdings are listed in the Executive Committee table.
(2) Aggregate number of share ownership at December 31, 2024.
(3) Aggregate number of unvested earnout share awards outstanding at December 31, 2024.
(4) Aggregate number of option/SARs awards outstanding at December 31, 2024.
(5) Aggregate number of earnout option awards outstanding at December 31, 2024.
(6) Equity securities this Director had the right to acquire, or to acquire “voting power” and/or “investment power”, as of December 31, 2024.
Equity and Equity-Linked Instruments Held by Members of the Executive Committee
The members of the Executive Committee and their related parties, if any, held the following equity and equity-linked instruments as of December 31, 2025:
Name |
Role |
Ordinary shares(1) |
|
Earnout shares(2) |
|
Option awards shares(3) |
|
Earnout option shares(4) |
|
Restricted stock units |
|
Vested award shares(5) |
|
||||||
Riad Sherif, M.D. |
Chief Executive Officer |
|
1,066,287 |
|
|
46,066 |
|
|
877,116 |
|
|
1,492 |
|
|
526,901 |
|
|
539,762 |
|
Sylvia Cheung |
Chief Financial Officer |
|
77,316 |
|
|
3,505 |
|
|
737,922 |
|
|
38,878 |
|
|
- |
|
|
495,057 |
|
Páll Ragnar Jóhannesson |
Chief Business Officer |
|
288,430 |
|
|
13,069 |
|
|
605,345 |
|
|
66,008 |
|
|
- |
|
|
689,432 |
|
Total |
|
|
1,432,033 |
|
|
62,640 |
|
|
2,220,383 |
|
|
106,378 |
|
|
526,901 |
|
|
1,724,251 |
|
(1) Aggregate number of share ownership outstanding at December 31, 2025.
(2) Aggregate number of unvested earnout share awards outstanding at December 31, 2025.
(3) Aggregate number of option awards outstanding at December 31, 2025.
(4) Aggregate number of earnout option awards outstanding at December 31, 2025.
(5) Equity securities this executive officer had the right to acquire, or to acquire “voting power” and/or “investment power”, as of December 31, 2025.
The members of the Executive Committee and their related parties, if any, held the following equity and equity-linked instruments as of December 31, 2024:
150
Name |
Role |
Ordinary shares(1) |
|
Earnout shares(2) |
|
Option awards shares(3) |
|
Earnout option shares(4) |
|
Restricted stock units |
|
Vested award shares(5) |
|
||||||
Riad Sherif, M.D. |
Chief Executive Officer |
|
947,585 |
|
|
115,165 |
|
|
877,116 |
|
|
1,492 |
|
|
196,808 |
|
|
276,701 |
|
Sylvia Cheung |
Chief Financial Officer |
|
72,062 |
|
|
8,759 |
|
|
555,356 |
|
|
38,878 |
|
|
- |
|
|
260,817 |
|
Páll Ragnar Jóhannesson |
Chief Business Officer |
|
268,827 |
|
|
32,672 |
|
|
494,701 |
|
|
66,008 |
|
|
- |
|
|
358,665 |
|
Total |
|
|
1,288,474 |
|
|
156,596 |
|
|
1,927,173 |
|
|
106,378 |
|
|
196,808 |
|
|
896,183 |
|
(1) Aggregate number of share ownership outstanding at December 31, 2024.
(2) Aggregate number of unvested earnout share awards outstanding at December 31, 2024.
(3) Aggregate number of option awards outstanding at December 31, 2024.
(4) Aggregate number of earnout option awards outstanding at December 31, 2024.
(5) Equity securities this executive officer had the right to acquire, or to acquire “voting power” and/or “investment power”, as of December 31, 2024.
151
5. Mandates outside the Company
According to article 39 of the Articles, limitations apply to mandates outside the Company for members of the Board of Directors and the Executive Committee. The following external mandates are subject to these limitations and are therefore presented in the Compensation Report.
Members of the |
Organization |
Position as of December 31, 2024 |
Position as of December 31, 2025 |
Anthony Rosenberg |
Cullinan Therapeutics Inc., US(2) |
Board Chair, Compensation Committee Member and Audit Committee Member |
Board Chair and Audit Committee Member |
|
Argenx BV, Belgium(2) |
Board Member, Audit Committee Member and Commercial Committee Member |
Board Member, Audit Committee Member and Commercial Committee Member |
|
TR Advisory Services GmbH, Switzerland |
|
Board Member and LLC Member |
|
Nuclidium AG, Switzerland |
Board Chair |
Board Chair |
Christina Ackermann |
Verona Pharma plc, UK(2) |
Board Member, Audit Committee Member and Commercial Committee Member |
|
|
Virometix AG, Switzerland |
Board Chair, Compensation Committee Chair and Audit Committee Member |
Board Chair, Compensation Committee Chair and Audit Committee Member |
Lionel Carnot |
iSTAR Medical SA, Belgium |
Board Member, Audit Committee Member and Compensation Committee Member |
|
|
Priothera Ltd., Ireland |
Board Member and Audit Committee Chair |
Board Member and Audit Committee Chair |
Arshad M. Khanani, M.D. |
|
|
|
Martijn Kleijwegt |
VICO Therapeutics International B.V., Belgium |
Board Member |
Board Member |
|
AM-Pharma Holding B.V., Netherlands |
Board Member |
Board Member |
|
Vicentra B.V., Netherlands |
Board Member |
|
|
Avidicure Holding B.V., Netherlands |
Board Member |
Board Member |
|
Pantera NV, Belgium |
Board Member |
Board Member |
|
LSP Advisory B.V., Netherlands |
Board Member |
Board Member |
Geraldine O’Keeffe |
T-Knife Therapeutics, Inc., U.S. |
Board Member and Audit Committee Member |
|
Robert Warner |
RxSight Inc., U.S.(2) |
Board Member, Nominating and Corporate Governance Committee Chair and Compensation Committee Member |
Board Member, Compensation Committee Member and Nominating and Corporate Governance Committee Chair |
|
EyeYon Medical Ltd., Israel |
Board Chair |
Board Chair and Compensation Committee Member |
|
i-Lumen Scientific Inc., US |
Board Member and Compensation Committee Member |
Board Member and Compensation Committee Member |
Members of the Executive Committee |
|
|
|
Riad Sherif, M.D. |
Revenio Group Oyi, Finland(2) |
Board Member and Compensation Committee Member |
Board Member and Compensation Committee Member |
|
NexMed Plus SA, Switzerland |
Board Chair |
Board Chair |
Sylvia Cheung |
|
|
|
Páll Ragnar Jóhannesson |
Sjónarhóll fjárfestingar ehf., Iceland |
Board Chair |
Board Chair |
|
Tæknisetur ehf., Iceland |
Board Member |
Board Member |
(1) Excludes Riad Sherif, M.D. whose mandates are listed in the Executive Committee table.
(2) Publicly listed companies.
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Forward Looking Statements
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains or may contain forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve significant risks and uncertainties. All statements other than statements of historical facts are forward-looking statements. These forward-looking statements include information about our possible or assumed future results of operations or our performance. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “expects,” “intends,” “plans,” “believes,” “anticipates,” “estimates,” “potential,” “continue,” “ongoing,” “targets,” “possible,” “project,” and “predict” and variations of such words and similar expressions are intended to identify the forward-looking statements. Forward-looking statements in this Annual Report may include, for example, statements about:
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These forward-looking statements are based on information available as of the date of this Annual Report, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, you should not place undue reliance on these forward-looking statements in deciding to invest in our securities. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. You should refer to the section entitled “Risk Factors,” included in Item 3.D. of the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 4, 2026 for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Annual Report.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Annual Report. And while we believe such information provides a reasonable basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely on these statements.
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