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Omeros Corporation (NASDAQ: OMER) turns profitable as YARTEMLEA revenue surges and debt falls

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8-K

Rhea-AI Filing Summary

Omeros Corporation reported strong second-quarter 2026 results driven by the U.S. launch of YARTEMLEA for TA-TMA. YARTEMLEA generated $32.2 million in gross revenue and $28.5 million in net product sales, a 190% increase in gross revenue from $11.1 million in the first quarter of 2026.

GAAP net income was $13.2 million, or $0.18 per basic share, versus a net loss of $25.4 million a year earlier, aided by an $11.4 million non-cash gain on financial instruments and $6.6 million income from discontinued operations. Non-GAAP adjusted net income was $1.8 million, or $0.02 per share. At June 30, 2026, cash and short-term investments totaled $132.0 million, and operating cash flow was $4.1 million for the quarter. The company repurchased $30.5 million principal of 2029 convertible notes, cutting outstanding principal to $40.3 million, eliminating $8.6 million in future interest and reducing potential dilution from 11.4 million to 6.5 million shares, and also retired 0.8 million common shares for $9.9 million. Omeros disclosed a negative CHMP opinion on its narsoplimab MAA in Europe and has requested re-examination while advancing multiple pipeline programs.

Positive

  • YARTEMLEA net product revenue rose to $28.5 million in Q2 2026, with gross revenue of $32.2 million, a 190% increase from $11.1 million in Q1 2026.
  • Returned to profitability: GAAP net income of $13.2 million in Q2 2026 versus a net loss of $25.4 million in Q2 2025; non-GAAP adjusted net income reached $1.8 million.
  • Strengthened balance sheet and reduced dilution by repurchasing $30.5 million of 2029 Notes, cutting principal to $40.3 million, eliminating $8.6 million in future interest and about 4.9 million potential conversion shares.
  • Positive operating and cash performance: Q2 2026 operating income of $0.1 million versus a Q1 2026 operating loss of $17.4 million, and $4.1 million net cash provided by operations.

Negative

  • European regulatory setback: CHMP adopted a negative opinion on the narsoplimab marketing authorization application for TA-TMA; Omeros has requested re-examination.
  • High leverage and obligations remain: OMIDRIA royalty obligations total $157.9 million and 2029 Notes carry $42.0 million non-current liability plus a $55.2 million embedded derivative.
  • Core earnings quality is modest: Q2 2026 non-GAAP adjusted net income was only $1.8 million, and reported net income relied heavily on an $11.4 million non-cash gain and $6.6 million income from discontinued operations.

Filing Explained

The August 12 Form 8-K furnishes second-quarter results and a June 30 balance sheet showing $132.0 million in cash and short-term investments.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
YARTEMLEA gross revenue Q2 2026 $32.2 million Second quarter 2026 gross revenues, up 190% from $11.1 million in Q1 2026
YARTEMLEA net revenue Q2 2026 $28.5 million Second quarter 2026 net product sales after ~11.5% gross-to-net adjustments
GAAP net income Q2 2026 $13,232 Three months ended June 30, 2026, including $11,447 non-cash gain and $6,595 discontinued ops
Non-GAAP adjusted net income Q2 2026 $1,785 Three months ended June 30, 2026, excludes remeasurement of fair value of financial instruments
Cash and short-term investments $132.0 million Cash and cash equivalents plus short-term investments at June 30, 2026
2029 Notes outstanding principal $40.3 million Aggregate principal amount remaining after July 2026 repurchases
OMIDRIA royalty obligation total $157,881 Current $21,511 and non-current $136,370 OMIDRIA royalty obligations at June 30, 2026
Share repurchases H1 2026 0.8 million shares; $9.9 million Shares repurchased and retired at $11.70 average price in six months ended June 30, 2026
thrombotic microangiopathy (TA-TMA) medical
"the first and only approved treatment for stem cell transplant-associated thrombotic microangiopathy (TA-TMA)"
New Technology Add-on Payment (NTAP) regulatory
"CMS granted New Technology Add-on Payment (NTAP) status to YARTEMLEA, effective October 1, 2026"
A new technology add-on payment (NTAP) is a temporary extra reimbursement from Medicare to hospitals that helps cover the higher initial costs of using an eligible, recently introduced medical device, drug or test. Think of it as a short-term subsidy that lowers the financial hurdle for hospitals to try a promising new tool; for investors it signals faster adoption, clearer early cash flow prospects, and improved reimbursement prospects for the technology maker.
embedded derivative financial
"mark-to-market adjustment of the embedded derivative associated with our unsecured convertible notes due 2029"
An embedded derivative is a built-in feature inside a contract—like a bond, loan, or lease—that causes part of the payout to change based on something else, such as a stock price, interest rate, or commodity price. It matters to investors because that hidden feature can add separate risk and volatility to a security’s value and accounting treatment, like finding a removable engine in a car that changes how fast it can go and how much it’s worth.
OMIDRIA contract royalty asset financial
"OMIDRIA contract royalty asset, short-term $25,603 and OMIDRIA contract royalty asset $90,875"
Non-GAAP adjusted net income (loss) financial
"We define non-GAAP adjusted net income (loss) as GAAP net income (loss) adjusted to exclude"
Committee for Medicinal Products for Human Use (CHMP) regulatory
"the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency"
The Committee for Medicinal Products for Human Use is the group of scientific experts at the European medicines regulator that assesses whether a medicine is safe, effective and high quality for use in people and issues the regulator’s formal scientific opinion. Investors watch its opinions because they act like a building inspector’s stamp for a drug — a positive opinion clears the path to sales across a large market and reduces regulatory risk, while a negative opinion can block or delay commercial plans.
YARTEMLEA gross revenue $32.2 million increase of 190% from $11.1 million in the first quarter of 2026
YARTEMLEA net revenue $28.5 million up from $9.9 million in the first quarter of 2026
GAAP net income (loss) $13.2 million improved from a net loss of $25.4 million in the three months ended June 30, 2025
Non-GAAP adjusted net income (loss) $1.8 million improved from a non-GAAP adjusted net loss of $33.6 million in the three months ended June 30, 2025
Net cash provided by operations $4.1 million company-wide net cash provided by operations for the three months ended June 30, 2026

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

How did Omeros (OMER) perform financially in the second quarter of 2026?

Omeros reported $28.5 million in net product sales and $13.2 million GAAP net income in Q2 2026. Non-GAAP adjusted net income was $1.8 million, and operating cash flow was $4.1 million, reflecting the first full quarter of YARTEMLEA commercialization.

What were Omeros’ YARTEMLEA revenues in Q2 2026 and how did they change?

YARTEMLEA generated $32.2 million in gross revenue and $28.5 million in net revenue in Q2 2026. Gross revenue increased 190% from $11.1 million in Q1 2026, with gross-to-net adjustments of about 11.5%.

What is Omeros’ cash position as of June 30, 2026?

As of June 30, 2026, Omeros held $132.0 million in cash and short-term investments, including $1.99 million in cash and equivalents and $129.97 million in short-term investments, supporting ongoing commercialization and pipeline development activities.

Did Omeros (OMER) repurchase any of its common stock in 2026?

Yes. During the six months ended June 30, 2026, Omeros repurchased and retired approximately 0.8 million shares of common stock at an average cost of $11.70 per share, for an aggregate purchase price of $9.9 million under its share repurchase program.

What regulatory development affected Omeros’ narsoplimab program in Europe?

In June 2026, the CHMP of the EMA adopted a negative opinion on Omeros’ marketing authorization application for narsoplimab in TA-TMA. Omeros believes clinical evidence supports approval and has requested re-examination, including review by an Ad Hoc Expert Group.

What upcoming reimbursement changes impact YARTEMLEA for Omeros (OMER)?

Effective July 1, 2026, a permanent J-code for YARTEMLEA took effect. CMS also granted NTAP status effective October 1, 2026, providing additional Medicare reimbursement to eligible hospitals for inpatient cases involving YARTEMLEA, which is expected to support patient access.
false 0001285819 0001285819 2026-08-12 2026-08-12
 


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):August 12, 2026

 
OMEROS CORPORATION
(Exact name of Registrant as Specified in Its Charter)
 

 
Washington
001-34475
91-1663741
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
     
201 Elliott Avenue West
Seattle, WA
 
98119
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrant’s Telephone Number, Including Area Code: (206) 676-5000
 
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities Registered Pursuant to Section 12(b) of the Act:
 
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common stock, $0.01 par value per share
OMER
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).         
Emerging growth company  
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 


 
 

 
Item 2.02 Results of Operations and Financial Condition.
 
On August 12, 2026, Omeros Corporation issued a press release announcing financial results for the three and six months ended June 30, 2026. A copy of such press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
 
The information in this Current Report on Form 8-K, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit, including any information contained on or accessible through any website reference in the exhibit shall not be incorporated by reference into any filing with the United States Securities and Exchange Commission made by Omeros Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The inclusion of any website address in this Current Report on Form 8-K by incorporation by reference of the press release is as an inactive textual reference only.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit
Number
 
Description
     
99.1
 
Press release, dated August 12, 2026, pertaining to Omeros Corporation's financial results for the three and six months ended June 30, 2026
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 
 

 
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 hereunto duly authorized.
 
     
 
OMEROS CORPORATION
     
Date: August 12, 2026
By:
/s/ Gregory A. Demopulos
   
Gregory A. Demopulos, M.D.
   
President, Chief Executive Officer and
   
Chairman of the Board of Directors
 
 

Exhibit 99.1

logo.jpg

 

 

Omeros Corporation Reports Second Quarter 2026 Financial Results

 

– Conference Call Today at 4:30 p.m. ET

 

 

SEATTLE, WA  August 12, 2026 – Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2026, which include:

 

Second Quarter and Recent Highlights

 

     YARTEMLEA®, the first and only approved treatment for stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-lethal complication of stem cell transplantation, generated gross revenues of $32.2 million in the second quarter of 2026, an increase of 190% from $11.1 million in the first quarter. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million and 11.0%, respectively, in the first quarter.

 

     Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share for the first quarter of 2026.

 

●     Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our unsecured convertible notes due 2029 (the “2029 Notes”). Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter.

 

●     At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million.

 

     In July 2026, we completed the repurchase of $30.5 million aggregate principal amount of our 2029 Notes for a total purchase price of $60.2 million, reducing the outstanding principal amount to approximately $40.3 million. The transactions also reduced the aggregate number of shares issuable upon conversion of the 2029 Notes from approximately 11.4 million to 6.5 million and eliminated $8.6 million in future interest payments. 

 

     During the three and six months ended June 30, 2026, we repurchased and retired approximately 0.5 million and 0.8 million shares of common stock, respectively, at an average cost of $11.70 per share, respectively, for aggregate purchase prices of $5.7 million and $9.9 million, respectively.

 

     In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on our marketing authorization application (MAA) for narsoplimab in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination. As part of the re-examination procedure, an Ad Hoc Expert Group (AHEG), expected to comprise external scientific and clinical experts in hematology and stem cell transplantation, will review the evidence and address questions central to CHMP’s assessment. We continue to make YARTEMLEA available to transplant physicians and their patients in Europe through our expanded access program, prioritizing children with TA-TMA.

 

“We are very pleased with the strong momentum and growing market acceptance in the first full quarter of YARTEMLEA’s commercial launch,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “Equally gratifying are the consistent reports from transplant physicians nationwide describing responses to YARTEMLEA in their adult and pediatric patients, including those who had not responded to prior off-label C5 inhibitor administration. YARTEMLEA is saving lives and, with FDA approval, is now broadly accessible in the U.S. Substantial second-quarter YARTEMLEA revenues have enabled us to continue strengthening our capital structure. We repurchased an additional 489,000 shares of common stock in the open market and reduced the outstanding principal amount of our 2029 convertible notes by 43%, eliminating nearly $9 million in future cash interest payments and approximately 5 million additional shares of potential dilution. At the same time, our work with Novo Nordisk on the MASP-3 inhibitor zaltenibart remained on track toward Phase 3 trial initiation, while our complement, addiction, oncology, and infectious disease programs continued advancing. Collectively, these programs position Omeros for a broad range of value-driving milestones over the next 18 months.”

 

 

 

Recent Developments

 

●     YARTEMLEA and our broader MASP-2 inhibitor platform

 

 ○       On July 1, 2026, the permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA became effective. Also in July, the Centers for Medicare & Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) status to YARTEMLEA, effective October 1, 2026. The NTAP designation provides eligible hospitals with additional Medicare reimbursement for inpatient cases involving YARTEMLEA and is expected to support patient access to this first-in-class treatment for TA-TMA.

 

 ○       We are assessing further development opportunities for YARTEMLEA across indications involving endothelial injury, lectin pathway activation, or thrombo-inflammation, including solid organ transplant-related TMA, chemotherapy-induced TMA, acute respiratory distress syndrome (ARDS), sickle cell disease, acute kidney injury, delayed graft function, and stem cell transplant-related endothelial syndromes beyond TA-TMA, including diffuse alveolar hemorrhage, capillary leak syndrome, graft-versus-host disease, and sinusoidal obstruction syndrome.

 

○       By year-end 2026, we expect enrollment to begin in two investigator-sponsored and Omeros-supported studies, one evaluating YARTEMLEA in hyperinflammatory ARDS, and the other assessing prophylactic YARTEMLEA in pediatric patients with predictably severe TA-TMA.

 

 ○       In parallel, we are finalizing the initial indication for a Phase 2 clinical program for OMS1029, our long-acting antibody targeting MASP-2. In our MASP-2 small-molecule inhibitor program, following completion of one ongoing study, we expect to select a drug development candidate.

 

●     OMS527 for the treatment of addiction — cocaine use disorder program funded by the National Institute on Drug Abuse (“NIDA”)

 

 ○       We are developing, at NIDA’s request, our lead orally administered phosphodiesterase 7 (“PDE7”) inhibitor for the treatment of cocaine use disorder. Preclinical studies, designed with NIDA toxicologists, were completed and showed no drug-interaction or safety issues, supporting the scheduled in-patient human study of OMS527 in cocaine users.

 

 ○       We are initiating a nonclinical study responsive to FDA’s request for additional nonclinical information prior to beginning the inpatient clinical trial. We expect to be able start enrollment in the inpatient clinical trial by year-end 2026. 

 

●     Oncology platform — OncotoX-AML/OMS805

 

 ○       We continue to progress development within our OncotoX-AML/OMS805 program targeting acute myeloid leukemia (“AML”), an aggressive and highly fatal bone marrow and blood cancer.

 

 ○       A first-in-human Phase 1b clinical trial evaluating OMS805, the lead drug development candidate in our OncotoX-AML program, is targeted to begin in late 2027. IND-enabling studies are underway, and we have entered into an agreement with a leading contract biologics manufacturer for process development and initial clinical supply of OMS805 drug substance.

 

 ○       Across tumor-bearing animal models and in vitro human AML cell-line studies, OMS805 demonstrated efficacy superior to current AML standards of care. This efficacy was independent of AML-related genetic mutations, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients.

 

 ○       In February 2026, we announced the successful completion of our initial study in nonhuman primates evaluating the efficacy and safety of OncotoX-AML. Administration of only one course of OncotoX-AML treatment to immunocompetent primates produced the desired pharmacologic response, selectively reducing myeloid progenitor cells by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values.

 

●     Targeted Complement Activating Therapy (“T-CAT”) platform

 

 ○       Our T-CAT platform is a new class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our T-CAT antibodies are expected to treat drug-resistant organisms without enhancing drug resistance. Our initial focus is on developing T-CAT antibodies against infections caused by multidrug-resistant organisms (“MDROs”), one of the most critical unmet needs in medicine.

 

 ○       The first peer-reviewed manuscript describing our T-CAT technology, titled “Engineered Antibodies Bypass Bacterial Immune Evasion to Drive Complement-Mediated Protection Against Lethal Infections,” was published in Science Translational Medicine on June 17, 2026. The manuscript underscores T-CAT’s potential as a next-generation platform with broad applicability across microbial species, including MDROs.

 

Financial Results

 

YARTEMLEA gross revenues were $32.2 million during the second quarter of 2026, an increase of $21.1 million, or 190%, from gross revenues of $11.1 million in the first quarter of 2026. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million, and gross-to-net adjustments of approximately 11.0% in the first quarter of 2026.

 

Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share, for the first quarter of 2026.

 

Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our 2029 Notes. Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter of 2026.

 

At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million.

 

On June 17, 2026, we entered into privately negotiated agreements to repurchase $16.0 million aggregate principal amount of 2029 Notes from certain holders. On July 2, 2026, we entered into additional privately negotiated agreements with the same holders to repurchase $14.5 million aggregate principal amount of 2029 Notes. Both transactions were completed in July 2026 for a total purchase price of $60.2 million, plus accrued and unpaid interest of $0.2 million. Approximately $40.3 million aggregate principal amount of 2029 Notes remains outstanding. The aggregate number of shares issuable on conversion of the 2029 Notes was reduced from approximately 11.4 million to 6.5 million as a result of the transactions. We achieved this reduction at a weighted average cost of $12.21 per share and concurrently eliminated $8.6 million in future interest payments.

 

Research and development and selling, general and administrative expenses totaled approximately $27.7 million in the second quarter, compared with $26.7 million in the first quarter. We reported operating income of $0.1 million for the second quarter compared with an operating loss of $17.4 million for the first quarter.

 

Interest and other income was $4.6 million for the second quarter of 2026 as compared to $1.5 million during the first quarter of 2026. The $3.1 million increase was primarily the result of a reimbursement from Novo Nordisk for the transfer of zaltenibart inventory. 

 

During the three months ended June 30, 2026, we repurchased and retired approximately 0.5 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $5.7 million. During the six months ended June 30, 2026, we repurchased and retired approximately 0.8 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $9.9 million.

 

Conference Call Details

 

Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.

 

For online access to the live webcast of the conference call, please register at the following URL https://events.q4inc.com/attendee/777037727 or go to Omeros’ website at https://investor.omeros.com/upcoming-events.

 

A replay of the call will be made accessible online for 90 days at https://investor.omeros.com/archived-events.

 

About Omeros Corporation

 

Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on the treatment of complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients two years of age and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

 

Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit www.omeros.com. 

 

 

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated therapeutic benefits of drug candidates within our development pipeline, statements of intention or expectations regarding our marketing authorization application for narsoplimab in Europe, plans and expectations regarding the commercial launch of YARTEMLEA® in the U.S., and in the EU following any EMA approval, our expectations regarding the effectiveness of the J-code and its utility, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in our marketing authorization application or our inability to respond satisfactorily to information requests during regulatory review, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties, and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026 and in our subsequently filed Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

Non-GAAP Financial Measures

 

This press release includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (GAAP). A non-GAAP financial measure is generally defined as one that purports to measure historical or future financial position, results of operations or cash flows but excludes or includes amounts that would not be included in most GAAP measures. We define non-GAAP adjusted net income (loss) as GAAP net income (loss) adjusted to exclude the non-cash remeasurement of the fair value of financial instruments.  We believe non-GAAP adjusted net income (loss) to be a more accurate measure in evaluating the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. This is not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Omeros’ financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting.

 

 

Contact:

 

 

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

 

 

 

OMEROS CORPORATION

 

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

 

(In thousands, except share and per share data)

 

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2026

   

2025

   

2026

   

2025

 

Product sales, net

  $ 28,529     $     $ 38,422     $  
                                 

Costs and expenses:

                           

Cost of product sales

    798             1,385        

Research and development

    13,798       22,009       27,156       45,855  

Selling, general and administrative

    13,859       10,345       27,228       21,468  

Total costs and expenses

    28,455       32,354       55,769       67,323  

Income (loss) from operations

    74       (32,354 )     (17,347 )     (67,323 )

Interest and other income

    4,626       1,241       6,101       2,363  

Interest expense, net of remeasurement adjustments and other

    (7,585 )     (15 )     (13,479 )     (3,669 )

Net gain on change in fair value of financial instruments

    11,447       8,207       84,593       8,142  

Loss on early extinguishment of 2029 Notes

    (1,896 )           (1,896 )      

Loss on early extinguishment of 2026 Notes

          (2,968 )           (2,968 )

Income (loss) from continuing operations before income tax expense

    6,666       (25,889 )     57,972       (63,455 )

Income tax expense

    (29 )           (86 )      

Net income (loss) from continuing operations

    6,637       (25,889 )     57,886       (63,455 )

Net income from discontinued operations, net of tax

    6,595       465       11,406       4,571  

Net income (loss)

  $ 13,232     $ (25,424 )   $ 69,292     $ (58,884 )
                         

Basic net income (loss) per share:

                       

Net income (loss) from continuing operations

  $ 0.09     $ (0.44 )   $ 0.80     $ (1.09 )

Net income from discontinued operations

    0.09       0.01       0.16       0.08  

Net income (loss)

  $ 0.18     $ (0.43 )   $ 0.96     $ (1.01 )
                         

Diluted net income (loss) per share:

                       

Net income (loss) from continuing operations

  $ 0.08     $ (0.44 )   $ 0.64     $ (1.09 )

Net income from discontinued operations

    0.07       0.01       0.13       0.08  

Net income (loss)

  $ 0.15     $ (0.43 )   $ 0.77     $ (1.01 )
                         

Weighted-average shares used in per share computation:

                               

Basic

    72,131,526       58,585,083       72,025,096       58,323,586  

Diluted

    89,625,663       58,585,083       89,881,452       58,323,586  

 

 

 

 

OMEROS CORPORATION

 

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

(In thousands)

 

   

June 30,

   

December 31,

 
   

2026

   

2025

 

Assets

           

Current assets:

           

Cash and cash equivalents

  $ 1,988     $ 9,660  

Short-term investments

    129,965       162,144  

OMIDRIA contract royalty asset, short-term

    25,603       25,351  

Receivables

    21,301       10,917  

Inventory

    842        

Prepaid expense and other assets

    5,541       7,595  

Total current assets

    185,240       215,667  

OMIDRIA contract royalty asset

    90,875       96,435  

Right of use assets

    8,284       10,708  

Property and equipment, net

    1,380       1,768  

Restricted investments

    1,054       1,054  

Total assets

  $ 286,833     $ 325,632  
             

Liabilities and shareholders’ deficit

               

Current liabilities:

               

Accounts payable

  $ 6,341     $ 4,764  

Accrued expenses

    29,269       29,388  

OMIDRIA royalty obligation

    21,511       20,547  

2029 Notes repurchase obligation, net

    31,259        

2026 Notes, net

          17,063  

Lease liabilities

    6,583       6,300  

Total current liabilities

    94,963       78,062  

OMIDRIA royalty obligation, non-current

    136,370       147,319  

2029 Notes, non-current, net

    42,032       51,364  

2029 Notes embedded derivative, non-current

    55,216       157,171  

Lease liabilities, non-current

    3,899       7,245  

Other accrued liabilities, non-current

    5,702       5,702  

Shareholders’ deficit:

               

Common stock and additional paid-in capital

    793,054       792,464  

Accumulated deficit

    (844,403 )     (913,695 )

Total shareholders’ deficit

    (51,349 )     (121,231 )

Total liabilities and shareholders’ deficit

  $ 286,833     $ 325,632  

 

 

 

OMEROS CORPORATION

 

UNAUDITED SCHEDULE OF INTEREST EXPENSE, NET OF REMEASUREMENT ADJUSTMENTS AND OTHER

 

(In thousands)

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2026

   

2025

   

2026

   

2025

 
   

(In thousands)

 

OMIDRIA royalty obligation

                               

Pass through interest remitted to administrative agent

  $ 3,885     $ 5,069       7,898       10,286  

Non-cash remeasurement adjustment

    556       (8,506 )     (853 )     (11,878 )

Interest expense, net of remeasurement on OMIDRIA royalty obligation

    4,441       (3,437 )     7,045       (1,592 )
                                 

2029 Notes

                               

Contractual interest expense

    1,681       859       3,362       859  

Amortization of debt discount and issuance costs

    1,438       748       2,883       748  

Interest expense on 2029 Notes

    3,119       1,607       6,245       1,607  
                                 

2026 Notes

                               

Contractual interest expense

          790       112       2,074  

Amortization of debt discount and issuance costs

          92       14       240  

Interest expense on 2026 Notes

          882       126       2,314  
                                 

Term Loan

                               

Contractual interest expense

          2,231             4,464  

Amortization of debt premium and issuance costs

          (1,306 )           (3,214 )

Interest expense on Term Loan

          925             1,250  
                                 

Finance leases and other

    25       38       63       90  
                                 

Total interest expense, net of remeasurement adjustments and other

  $ 7,585     $ 15     $ 13,479     $ 3,669  

 

 

 

 

OMEROS CORPORATION

 

UNAUDITED GAAP TO NONGAAP RECONCILIATION

 

(In thousands)

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2026

   

2025

   

2026

   

2025

 

Reconciliation of GAAP net income (loss) to Non-GAAP adjusted net income (loss)

                               
                                 

Numerator (in thousands)

                               

Net income (loss)

  $ 13,232     $ (25,424 )   $ 69,292     $ (58,884 )

Less: remeasurement of fair value of financial instruments

    (11,447 )     (8,207 )     (84,593 )     (8,142 )
                                 

Non-GAAP adjusted net income (loss)

  $ 1,785     $ (33,631 )   $ (15,301 )   $ (67,026 )
                                 

Denominator (in shares)

                               

Basic weighted average shares

    72,131,526       58,585,083       72,025,096       58,323,586  
                                 

Net income (loss) per share basic

  $ 0.18     $ (0.43 )   $ 0.96     $ (1.01 )
                                 

Non-GAAP adjusted net income (loss) per share basic

  $ 0.02     $ (0.57 )   $ (0.21 )   $ (1.15 )

 

 

 

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