EyePoint Reports Fourth Quarter and Full-Year 2024 Financial Results and Highlights Recent Corporate Developments
Rhea-AI Summary
EyePoint Pharmaceuticals (NASDAQ: EYPT) reported Q4 and full-year 2024 financial results, highlighting significant progress in its DURAVYU clinical trials. The LUGANO Phase 3 trial for wet AMD is over 50% enrolled, with both LUGANO and LUCIA trials expected to complete enrollment in H2 2025 and topline data in 2026.
The company reported positive Phase 2 VERONA trial results for DURAVYU in DME, meeting primary and secondary endpoints. Q4 2024 financial results showed total net revenue of $11.6M (down from $14.0M in Q4 2023), with a net loss of $41.4M ($0.64 per share).
Full-year 2024 results included total net revenue of $43.3M (compared to $46.0M in 2023) and a net loss of $130.9M ($2.32 per share). The company maintains a strong financial position with $371M in cash and investments as of December 31, 2024, providing runway into 2027.
Positive
- Strong cash position of $371M providing runway into 2027
- DURAVYU Phase 3 trials enrollment exceeding expectations
- Positive Phase 2 VERONA trial results in DME
- Clear regulatory pathway for wet AMD indication
Negative
- Q4 revenue declined to $11.6M from $14.0M YoY
- Net loss increased to $41.4M from $14.1M YoY
- Operating expenses increased to $56.8M from $30.4M YoY
- Full-year revenue decreased to $43.3M from $46.0M
News Market Reaction
On the day this news was published, EYPT gained 8.22%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
– Enrollment exceeding expectations in DURAVYU™ Phase 3 wet AMD clinical trials with LUGANO over
– Positive Phase 2 VERONA clinical trial of DURAVYU for DME met primary and secondary endpoints –
–
WATERTOWN, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the fourth quarter and full-year ended December 31, 2024, and highlighted recent corporate developments.
“We are off to a strong start in 2025, as we advance our best-in-class sustained delivery therapy DURAVYU across clinical programs in the two largest retinal disease markets, wet age-related macular degeneration (AMD) and diabetic macular edema (DME),” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint. “Notably, enrollment in both the LUGANO and LUCIA Phase 3 clinical trials in wet AMD continues to exceed our expectations with LUGANO well over
R&D Highlights and Updates
- Global Phase 3 LUGANO and LUCIA pivotal trials of DURAVYU in wet AMD well underway with both trials exceeding expectations. The LUGANO trial is over
50% enrolled, significantly exceeding observed historical enrollment rates of both comparable and competitive wet AMD trials. We remain on-track to complete enrollment of both trials in the second half of 2025 with topline data anticipated in 2026. The non-inferiority trials include six-month re-dosing and follow a clear and recognized pathway for potential global regulatory and commercial success. - In March 2025, we presented positive 24-week supplement-free patient subgroup analyses from the Phase 2 VERONA clinical trial in DME demonstrating that DURAVYU 2.7mg significantly improved vision and fluid versus baseline compared to the aflibercept control group, including:
- BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control
- CST improvement of 117.4 microns versus 43.7 microns for aflibercept control
43% had an absence of DME compared to zero for the aflibercept control arm.
These results confirm that the positive data from the Phase 2 VERONA trial were driven by DURAVYU.
- In February 2025, we announced positive topline 24-week data for the Phase 2 VERONA clinical trial of DURAVYU for DME meeting primary and secondary endpoints. Visual and anatomical gains were observed as early as Week 4 compared to aflibercept control, demonstrating the immediate bioavailability of DURAVYU and its differentiated profile as a sustained-release TKI. The DURAVYU treatment arms demonstrated a continued favorable safety and tolerability profile.
- Presented datasets at key medical conferences that highlight the meaningful efficacy, strong durability and continued safety of DURAVYU. Presentations included:
- Phase 2 DAVIO 2 12-month clinical trial results for DURAVYU in wet AMD at the Hawaiian Eye & Retina annual meeting in January.
- DAVIO 2 end-of-trial results and 16-week interim results from the VERONA trial in DME at Angiogenesis, Exudation, and Degeneration 2025 in February.
- An assessment showcasing the meaningful reduction in treatment burden in wet AMD patients treated with DURAVYU versus aflibercept at the Macula Society Annual Meeting in February.
- Accepted to present at the upcoming 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May, showcasing EyePoint’s robust dataset across multiple indications with continued best-in-class safety and efficacy, as well as the program’s de-risked study designs that reflect real-world patient populations.
Recent Corporate Highlights
- Announced the appointment of renowned retina specialist and industry leader Reginald J. Sanders M.D., FASRS to the Company’s Board of Directors in January.
Review of Results for the Fourth Quarter Ended December 31, 2024
For the fourth quarter ended December 31, 2024, total net revenue was
Net revenue from license and royalties for the fourth quarter ended December 31, 2024, totaled
Operating expenses for the fourth quarter ended December 31, 2024, totaled
Net non-operating income totaled
Review of Results for the Full Year Ended December 31, 2024
For the full year ended December 31, 2024, total net revenue was
Net revenue from license and royalties for the full year ended December 31, 2024, totaled
Operating expenses for the full year ended December 31, 2024, totaled
Net non-operating income totaled
Cash, cash equivalents, and investments in marketable securities on December 31, 2024, totaled
Financial Outlook
We expect the cash, cash equivalents, and investments on December 31, 2024, will enable us to fund operations into 2027 beyond topline Phase 3 data for DURAVYU in wet AMD expected in 2026. Accordingly, we currently have no plans to access the equity capital markets in 2025.
Conference Call Information
EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and full-year ended December 31, 2024 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI804e9c71d61543cab2c16376caae4936. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About EyePoint
EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. Supported by robust safety and efficacy data to date, DURAVYU is presently in Phase 3 global, pivotal clinical trials for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States and recently completed a Phase 2 clinical trial in diabetic macular edema (DME). Based on positive Phase 2 results from the VERONA clinical trial in DME, EyePoint anticipates meeting with U.S. and ex-U.S. regulatory agencies in the second quarter of 2025 to confirm plans for a pivotal program.
Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products in multiple disease indications. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.
DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
Forward Looking Statements
EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding the timing and clinical development and potential of DURAVYU in DME and wet AMD, including our expectations regarding the VERONA trial following our announcement of full topline data and the progress of our ongoing LUGANO and LUCIA trials; our beliefs and expectations that the full topline results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision without sacrificing anatomy; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
Investors:
Christina Tartaglia
Precision AQ
Direct: 212-698-8700
christina.tartaglia@precisionaq.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES | |||||||
| CONSOLIDATED BALANCE SHEETS | |||||||
| (In thousands) | |||||||
| December 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 99,704 | $ | 281,263 | |||
| Marketable securities | 271,209 | 49,787 | |||||
| Accounts and other receivables, net | 607 | 805 | |||||
| Prepaid expenses and other current assets | 9,481 | 9,039 | |||||
| Inventory | 2,305 | 3,906 | |||||
| Total current assets | 383,306 | 344,800 | |||||
| Operating lease right-of-use assets | 21,000 | 4,983 | |||||
| Other assets | 14,159 | 5,401 | |||||
| Total assets | $ | 418,465 | $ | 355,184 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 29,824 | $ | 24,025 | |||
| Deferred revenue | 17,784 | 38,592 | |||||
| Other current liabilities | 1,440 | 646 | |||||
| Total current liabilities | 49,048 | 63,263 | |||||
| Deferred revenue - noncurrent | 10,853 | 20,692 | |||||
| Operating lease liabilities - noncurrent | 21,858 | 4,906 | |||||
| Other noncurrent liabilities | 205 | - | |||||
| Total liabilities | 81,964 | 88,861 | |||||
| Stockholders' equity: | |||||||
| Capital | 1,208,489 | 1,007,605 | |||||
| Accumulated deficit | (873,016 | ) | (742,146 | ) | |||
| Accumulated other comprehensive income | 1,028 | 864 | |||||
| Total stockholders' equity | 336,501 | 266,323 | |||||
| Total liabilities and stockholders' equity | $ | 418,465 | $ | 355,184 | |||
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES | |||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (In thousands, except per share data) | |||||||||||||||
| Three Months Ended | Twelve Months Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues: | |||||||||||||||
| Product sales, net | $ | 774 | $ | 749 | $ | 3,164 | $ | 14,232 | |||||||
| License and collaboration agreements | 10,590 | 13,029 | $ | 38,496 | 30,797 | ||||||||||
| Royalty income | 224 | 250 | $ | 1,613 | 989 | ||||||||||
| Total revenues | 11,588 | 14,028 | 43,273 | 46,018 | |||||||||||
| Operating expenses: | |||||||||||||||
| Cost of sales | 816 | 998 | 3,712 | 4,632 | |||||||||||
| Research and development | 43,372 | 17,951 | 132,926 | 64,662 | |||||||||||
| Sales and marketing | 51 | 185 | 131 | 11,689 | |||||||||||
| General and administrative | 12,588 | 11,248 | 52,358 | 40,102 | |||||||||||
| Total operating expenses | 56,827 | 30,382 | 189,127 | 121,085 | |||||||||||
| Loss from operations | (45,239 | ) | (16,354 | ) | (145,854 | ) | (75,067 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest and other income, net | 3,944 | 2,338 | 15,088 | 6,949 | |||||||||||
| Interest expense | (14 | ) | - | (14 | ) | (1,247 | ) | ||||||||
| Loss on extinguishment of debt | - | - | - | (1,347 | ) | ||||||||||
| Total other income, net | 3,930 | 2,338 | 15,074 | 4,355 | |||||||||||
| Net loss before provision for income taxes | $ | (41,309 | ) | $ | (14,016 | ) | $ | (130,780 | ) | $ | (70,712 | ) | |||
| Provision for income taxes | $ | (90 | ) | $ | (83 | ) | $ | (90 | ) | $ | (83 | ) | |||
| Net loss | $ | (41,399 | ) | $ | (14,099 | ) | $ | (130,870 | ) | $ | (70,795 | ) | |||
| Net loss per common share - basic and diluted | $ | (0.64 | ) | $ | (0.33 | ) | $ | (2.32 | ) | $ | (1.82 | ) | |||
| Weighted average common shares outstanding - basic and diluted | 64,556 | 42,168 | 56,298 | 38,904 | |||||||||||
FAQ
What are the enrollment status and timeline for EYPT's DURAVYU Phase 3 trials in wet AMD?
How much cash does EYPT have and how long will it last?
What were the key findings from EYPT's Phase 2 VERONA trial for DME?
What were EYPT's Q4 2024 financial results?
