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FDA OKs YARTEMLEA as Omeros (NASDAQ: OMER) lands $240M zaltenibart deal

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Omeros Corporation reported a sharp turnaround in late 2025, driven by a major asset sale and its first U.S. drug approval. Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share, a year earlier. For full-year 2025, net loss narrowed to $3.4 million, or $0.05 per share, from a $156.8 million loss in 2024.

Results reflected a $237.6 million net gain from the zaltenibart transaction with Novo Nordisk and a $136.0 million non-cash loss from marking embedded derivatives on the company’s 2029 Notes and Term Loan. Excluding this non-cash item, non-GAAP adjusted net income was $222.5 million, or $3.14 per share, for the quarter and $133.4 million, or $2.10 per share, for the year.

At December 31, 2025, Omeros held $171.8 million in cash and short-term investments and had $87.9 million in aggregate principal debt, down from $164.9 million a year earlier after using Novo Nordisk proceeds to repay its senior secured term loan and 2026 convertible notes. The company also achieved FDA approval and U.S. launch of YARTEMLEA for TA-TMA, began commercial sales in January 2026, and highlighted progress across its oncology, PDE7, and T-CAT infectious disease programs.

Positive

  • Transformative profitability and de-leveraging: Q4 2025 net income of $86.5 million versus a prior-year loss, non-GAAP adjusted net income of $222.5 million, and reduction of aggregate principal debt to $87.9 million from $164.9 million.
  • Major strategic transaction with Novo Nordisk: $240.0 million upfront cash, a $237.6 million net gain on sale of zaltenibart, eligibility for up to $510.0 million in development and approval milestones and $1.3 billion in sales-based milestones, plus tiered royalties.
  • First FDA-approved product and active launch: YARTEMLEA approved in the U.S. for TA-TMA, commercial distribution started January 2026, with both adult and pediatric patients now being treated.
  • Strengthened balance sheet: Cash and short-term investments of $171.8 million at December 31, 2025, full repayment of the $67.1 million senior secured term loan and $17.1 million of 2026 convertible notes.

Negative

  • None.

Insights

Omeros posts a deal-driven profit, wins first approval, and de-levers its balance sheet.

Omeros delivered a rare combination for a small biotech: its first FDA-approved product and a large monetization of a late-stage asset. Q4 2025 net income of $86.5 million reflects a $237.6 million gain from selling zaltenibart rights to Novo Nordisk, offset by a sizable non-cash loss on embedded derivatives.

Stripping out the derivative mark-to-market, non-GAAP adjusted net income reached $222.5 million for the quarter and $133.4 million for 2025, signaling strong underlying economics from the deal. Cash and short-term investments of $171.8 million and reduced debt of $87.9 million after fully repaying the senior term loan and 2026 notes improve financial flexibility heading into the YARTEMLEA launch.

Strategically, FDA approval of YARTEMLEA for TA-TMA establishes Omeros as a commercial-stage company, while the zaltenibart transaction adds up to $1.8 billion in potential milestones plus royalties. Actual long-term value will depend on YARTEMLEA uptake, Novo Nordisk’s development success, and execution of the broader pipeline.

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.
Q4 2025 net income $86.5 million; $1.22 per share Fourth quarter 2025 vs prior-year net loss of $31.4 million
Full-year 2025 net loss $3.4 million; $0.05 per share Year ended December 31, 2025 vs $156.8 million loss in 2024
Non-GAAP adjusted net income $222.5 million Q4; $133.4 million FY Excludes non-cash loss on change in fair value of financial instruments in 2025
Zaltenibart sale gain and upfront cash $237.6 million gain; $240.0 million upfront Net proceeds and upfront payment from Novo Nordisk transaction in Q4 2025
Cash and investments $171.8 million Cash and short-term investments at December 31, 2025
Debt balance $87.9 million Aggregate principal amount of debt at December 31, 2025, down from $164.9 million in 2024
OMIDRIA Q4 2025 royalties $9.2 million on $30.7 million sales Royalties from Rayner Surgical on U.S. OMIDRIA net sales in Q4 2025
2025 operating expenses $122.8 million Total operating expenses for year ended December 31, 2025 vs $167.0 million in 2024
non-GAAP adjusted net income financial
"Excluding the non-cash charge associated with the embedded derivatives, non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million..."
A company’s non-GAAP adjusted net income is its reported profit after management removes certain expenses or gains that it considers one-time, nonrecurring, or not part of core operations (for example, restructuring costs or stock-based pay). Investors watch it as an attempt to show the company’s ongoing earning power — like looking at a cleaned-up weekly budget — but because companies choose what to exclude, it’s important to compare the underlying details rather than the headline number alone.
embedded derivatives financial
"The fourth quarter also includes a $136.0 million non-cash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 Notes and Term Loan."
An embedded derivative is a hidden financial option or payout rule built into a larger contract—like a bond, loan, or supply agreement—that makes part of the deal behave like a separate financial bet whose value swings with interest rates, currencies, commodity prices, or a company’s stock. Investors care because these built‑in features can change reported assets, liabilities and profits and add unexpected risk or upside, like finding a bonus or penalty clause inside a rental lease.
hematopoietic stem cell transplant-associated thrombotic microangiopathy medical
"YARTEMLEA® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”) in adults and in children..."
Hematopoietic stem cell transplant-associated thrombotic microangiopathy is a rare but serious complication that can occur after a stem cell transplant, where small blood vessels become damaged and form clots, leading to reduced blood flow and potential organ problems. This condition matters to investors because it can increase healthcare costs, impact treatment success rates, and influence the financial stability of medical providers and biotech companies developing related therapies.
marketing authorization application regulatory
"A marketing authorization application (“MAA”) for YARTEMLEA for the treatment of TA-TMA is currently under review by EMA..."
A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.
OMIDRIA contract royalty asset financial
"OMIDRIA contract royalty asset, short-term ... OMIDRIA contract royalty asset ..."
Term debt, embedded derivative financial
"Term debt, embedded derivative, non-current | | | — | | | | (235 | )"
Q4 2025 net income $86.5 million; $1.22 per share vs. $31.4 million net loss; $0.54 loss per share in Q4 2024
FY 2025 net loss $3.4 million; $0.05 per share vs. $156.8 million net loss; $2.70 loss per share in 2024
Q4 2025 non-GAAP adjusted net income $222.5 million; $3.14 per share reflects exclusion of non-cash fair value loss on financial instruments
FY 2025 non-GAAP adjusted net income $133.4 million; $2.10 per share excludes non-cash remeasurement of financial instruments
false 0001285819 0001285819 2026-03-31 2026-03-31
 


 
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):March 31, 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 March 31, 2026, Omeros Corporation issued a press release announcing financial results for the three and twelve months ended December 31, 2025. 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 March 31, 2026, pertaining to Omeros Corporation's financial results for the three and twelve months ended December 31, 2025
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
*              Certain identified information has been excluded from the exhibit because it both (A) is not material and (B) would be competitively harmful if publicly disclosed.
 
 

 
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: March 31, 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 Fourth Quarter and Year-End 2025 Financial Results

 

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

 

 

SEATTLE, WA  March 31, 2026 – Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2025, which include:

 

●     Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share, for the fourth quarter of 2024. For the year ended December 31, 2025, net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share, in the prior year. 

 

●     Fourth quarter results include a net gain of $237.6 million tied to the zaltenibart transaction with Novo Nordisk. The fourth quarter also includes a $136.0 million non-cash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 Notes and Term Loan. Excluding the non-cash charge associated with the embedded derivatives, non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.

 

●     At December 31, 2025, we had $171.8 million of cash and short-term investments. We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 47%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.

 

Fourth Quarter and Recent Highlights

 

     On November 25, 2025, we closed the previously announced transaction with Novo Nordisk Health Care AG (“Novo Nordisk”).  Pursuant to the Asset Purchase and License Agreement (“APLA”), Novo Nordisk received exclusive global rights in all indications to develop and commercialize zaltenibart (formerly OMS906), our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”) and certain related antibodies and products. Omeros retains rights to its MASP-3 small-molecule program unrelated to zaltenibart, including the ability to develop and commercialize small-molecule MASP-3 inhibitors with limited restrictions on indications. Omeros also retains rights to its “grandfathered” MASP-3 antibodies, with temporal and indication restrictions on commercialization and for use in advancing its small-molecule therapeutics.

       

At closing, we received an upfront cash payment of $240.0 million. In addition, we are eligible to receive:

 

● Up to $100.0 million in near-term milestone payments and an additional $410.0 million in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of each of the development and approval milestone events as set forth in the APLA;

 

● Up to $1.3 billion in one-time milestone payments upon the achievement by Novo Nordisk or its affiliates or sublicensees of certain sales-based and commercial milestone events; plus

 

● Tiered royalties on annual global net sales of applicable products at rates ranging from a high single-digit to high-teens.

 

     Omeros used a portion of the cash received at closing of the Novo Nordisk transaction to repay the entire $67.1 million principal amount outstanding under its senior secured term loan, along with a related prepayment premium, accrued and unpaid interest, and expenses. The prepayment resulted in the termination of the corresponding credit agreement and the release in full of all liens and covenants thereunder. Another portion of the cash was subsequently used to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026.

 

●     On December 23, 2025, the U.S. Food and Drug Administration (“FDA”) approved YARTEMLEA® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”) in adults and in children ages two years and older. YARTEMLEA is the first and only approved therapy for TA-TMA, an often-fatal complication of stem cell transplantation driven by activation of the lectin pathway of complement. YARTEMLEA selectively inhibits MASP-2, the effector enzyme of the lectin pathway, blocking pathway activation while preserving classical and alternative complement functions important for host defense against infection.

 

     Commercial distribution and sales of YARTEMLEA began in January 2026. Both adult and pediatric patients with TA-TMA are now receiving YARTEMLEA, including patients who have recently failed prior off-label C5- and C3-inhibitor regimens, in both hospital and outpatient settings.

 

●     We are commercializing YARTEMLEA in the U.S. market and have deployed our field force of account managers and directors, market development managers, access leads, and medical science liaisons to engage directly with transplant centers across the United States.

 

●     A marketing authorization application (“MAA”) for YARTEMLEA for the treatment of TA-TMA is currently under review by EMA with a decision expected in mid-2026. If approved, the MAA authorizes the product to be marketed in all EU member states and European Economic Area countries.

 

“In the fourth quarter of 2025, Omeros delivered transformative achievements for our shareholders,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “Following FDA approval of YARTEMLEA with a broad label and no boxed warning, REMS, or required vaccinations, our commercial launch is well underway, and patients who urgently need the drug are now able to access it. Our partnership with Novo Nordisk expands the breadth of indications being pursued for zaltenibart and has provided — and should continue to provide — substantial operating capital while underscoring the value of our science. These successes are expected to fuel the development of a growing portfolio of commercial products from our robust pipeline as we target positive cash flow in 2027.”

 

 

 

Recent Developments

 

●     Recent developments in other programs include the following: 

 

● We were previously awarded a three-year, $6.24 million grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered phosphodiesterase 7 (“PDE7”) inhibitor for the treatment of cocaine use disorder. The grant is intended to support (i) preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration and (ii) an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adult cocaine users who receive concurrent intravenous cocaine. The 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. FDA subsequently requested additional preclinical information prior to initiating the clinical in-patient study in cocaine users. Together with our collaborators at NIDA, we are scheduled to meet with FDA in the coming quarter to discuss that request.

 

● We continue to progress preclinical studies within our novel oncology program, which is focused on developing novel, proprietary large-molecule therapeutics designed to selectively target and kill dividing cancer cells. The lead indication for development is acute myeloid leukemia (“AML”), an aggressive and highly fatal bone marrow and blood cancer. We have completed selection of a drug development candidate, and IND-enabling studies are underway for this program, which we refer to as OncotoX-AML.

 

 o       OncotoX-AML shows broad application across AML regardless of genetic mutation, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients. In human tumor-bearing animal and in vitro human AML cell-line studies, our AML therapeutic candidate has demonstrated superior efficacy to current AML standard of care treatments.

 o       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 demonstrated the desired pharmacologic response, specifically marked, selective, reversible, and dose-related reduction in myeloid progenitor cells — the cells that can mutate and lead to AML — by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values.

 

● Our Targeted Complement Activating Therapy (“T-CAT”) platform — a new class of recombinant antibodies designed to target and directly kill bacteria, fungi, viruses, and parasites — continues to amass animal data across multiple pathogen classes and species. Our initial focus is on multidrug-resistant organisms (“MDROs”), widely recognized as one of the most critical unmet needs in medicine. In well-established in vivo animal models considered predictive of efficacy in humans, T-CAT recombinant antibodies demonstrated effectiveness in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria, including those designated by the World Health Organization as priority pathogens. A publication on our T-CAT platform is expected in the coming weeks.

 

Financial Results

 

During the fourth quarter, we recognized $237.6 million in net proceeds from the sale of zaltenibart to Novo Nordisk. This represents $240.0 million in upfront cash from Novo Nordisk net of transaction related costs of $2.4 million. 

 

With funds received from Novo Nordisk, we fully repaid $67.1 million in principal outstanding under our senior secured credit agreement in November 2025. 

 

At December 31, 2025, we had $171.8 million of cash and short-term investments. We used available cash on hand to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026. 

 

We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 46.7%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.

 

Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share for the fourth quarter of 2024. For the year ended December 31, 2025, our net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share in the prior year.

 

The change in fair value of financial instruments as shown in our statement of operations and comprehensive loss reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net loss on change in fair value of financial instruments which is non-cash, our non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.

 

For the fourth quarter of 2025, we earned OMIDRIA royalties of $9.2 million from Rayner Surgical Inc. on U.S. net sales of $30.7 million. This compares to earned OMIDRIA royalties of $10.1 million during the fourth quarter of 2024 on U.S. net sales of $33.6 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, (“DRI”), all U.S.-based royalties through 2031 are remitted from Rayner to DRI through an escrow agent. 

 

Total operating expenses for the year ended December 31, 2025 were $122.8 million compared to $167.0 million for the year ended December 31, 2024. The $44.2 million decrease was primarily due to timing of manufacturing batches, as Omeros released approximately $21.9 million of drug substance in the prior year as well as completed work on the Phase 1 OMS1029 and IgA nephropathy studies. In addition, we reduced expenditures on certain activities in the current year to conserve capital in anticipation of our expected commercial launch of YARTEMLEA.

 

Interest expense decreased $25.6 million in 2025 compared to 2024.  The decrease primarily relates to a $27.8 million change in non-cash remeasurement costs on the OMIDRIA royalty obligation to reflect a change in forecasted OMIDRIA cash flows from Rayner.  Excluding any non-cash remeasurement adjustments of the DRI royalty obligation and any amortization of debt discount, premium, or issuance costs, contractual interest expense remained relatively unchanged from the prior year.

 

Interest and other income was $4.1 million in 2025 compared to $11.3 million in 2024. The difference is primarily due to lower average cash and investments balances available to invest in the current year.

 

Net income from discontinued operations, net of tax, was $1.5 million, or $0.02 net income per share, in 2025 compared to net income from discontinued operations, net of tax of $25.8 million, or $0.44 net income per share, in 2024. The decrease was primarily attributable to non-cash remeasurements.

 

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/106692151 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 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 aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

 

Under a recently announced 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, expectations regarding our marketing authorization application for YARTEMLEA® in Europe, plans and expectations regarding the commercial launch of YARTEMLEA in the U.S., and in the EU following any EMA approval, 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 inability to respond satisfactorily to information requests during regulatory review of the thereof, 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. 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 and use the non-GAAP financial measure of Adjusted Net Loss which represents net loss adjusted to remove the non-cash remeasurement on the fair value of financial instruments.  We believe Adjusted Net Loss and Adjusted Net Loss from Continuing Operations to be a more accurate measure in gauging the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. These are 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 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

 

(In thousands, except share and per share data)

 

 

   

Three Months Ended

   

Twelve Months Ended

 
   

December 31,

   

December 31,

 
   

2025

   

2024

   

2025

   

2024

 
                         

Costs and expenses:

                           

Research and development

  $ 19,446     $ 23,320     $ 81,296     $ 119,523  

Selling, general and administrative

    9,635       10,035       41,500       47,430  

Total costs and expenses

    29,081       33,355       122,796       166,953  

Loss from operations

    (29,081 )     (33,355 )     (122,796 )     (166,953 )

Gain on sale of zaltenibart

    237,594             237,594        

Gain on early extinguishment of term debt, net

    17,035             17,035        

Loss on early extinguishment of 2026 Notes

                (2,968 )      

Interest and other income

    1,118       2,296       4,096       11,285  

Interest expense, net of remeasurement adjustments and other

    (8,726 )     (3,177 )     960       (24,675 )

Gain (loss) on change in fair value of financial instruments, net

    (136,038 )           (136,717 )     19  

Loss from continuing operations before income tax expense

    81,902       (34,236 )     (2,796 )     (180,324 )

Income tax expense

    (2,012 )     (2,305 )     (2,012 )     (2,305 )

Net loss from continuing operations, net of tax

    79,890       (36,541 )     (4,808 )     (182,629 )

Net income from discontinued operations, net of tax

    6,561       5,183       1,458       25,814  

Net income (loss)

  $ 86,451     $ (31,358 )   $ (3,350 )   $ (156,815 )
                         

Basic net income (loss) per share:

                       

Net income (loss) from continuing operations

  $ 1.13     $ (0.63 )   $ (0.08 )   $ (3.14 )

Net income from discontinued operations

    0.09       0.09       0.03       0.44  

Net income (loss)

  $ 1.22     $ (0.54 )   $ (0.05 )   $ (2.70 )
                         

Diluted net income (loss) per share:

                       

Net income (loss) from continuing operations

  $ 0.90     $ (0.63 )   $ (0.08 )   $ (3.14 )

Net income from discontinued operations

    0.08       0.09       0.03       0.44  

Net income (loss)

  $ 0.98     $ (0.54 )   $ (0.05 )   $ (2.70 )
                         

Weighted-average shares used in per share computation:

                       

Basic

    70,829,424       57,987,961       63,510,201       58,170,931  

Diluted

    88,475,735       57,987,961       63,510,201       58,170,931  

 

 

 

 

 

OMEROS CORPORATION

 

UNAUDITED CONSOLIDATED BALANCE SHEETS

 

(In thousands)

 

   

December 31,

   

December 31,

 
   

2025

   

2024

 

Assets

           

Current assets:

           

Cash and cash equivalents

  $ 9,660     $ 3,400  

Short-term investments

    162,144       86,732  

OMIDRIA contract royalty asset, short-term

    25,351       29,083  

Receivables

    10,917       7,739  

Prepaid expense and other assets

    7,595       7,166  

Total current assets

    215,667       134,120  

OMIDRIA contract royalty asset

    96,435       124,266  

Right of use assets

    10,708       14,961  

Property and equipment, net

    1,768       2,678  

Restricted investments

    1,054       1,054  

Total assets

  $ 325,632     $ 277,079  
             

Liabilities and shareholders’ equity/(deficit)

               

Current liabilities:

               

Accounts payable

  $ 4,764     $ 5,905  

Accrued expenses

    29,388       26,005  

OMIDRIA royalty obligation

    20,547       20,645  

2026 Notes, net

    17,063        

Term debt

          21,000  

Lease liabilities

    6,300       5,971  

Total current liabilities

    78,062       79,526  

OMIDRIA royalty obligation, non-current

    147,319       195,612  

2026 and 2029 Notes, non-current, net

    51,364       97,178  

2029 Notes embedded derivative, non-current

    157,171        

Term debt, non-current, net

          69,640  

Term debt, embedded derivative, non-current

          (235 )

Lease liabilities, non-current

    7,245       13,466  

Other accrued liabilities, non-current

    5,702       4,501  

Shareholders’ equity/(deficit):

               

Common stock and additional paid-in capital

    792,464       727,736  

Accumulated deficit

    (913,695 )     (910,345 )

Total shareholders’ equity (deficit)

    (121,231 )     (182,609 )

Total liabilities and shareholders’ equity (deficit)

  $ 325,632     $ 277,079  

 

 

 

OMEROS CORPORATION

 

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

 

(In thousands)

 

   

Three Months Ended

   

Twelve Months Ended

 
   

December 31,

   

December 31,

 
   

2025

   

2024

   

2025

   

2024

 
   

(In thousands)

 

OMIDRIA royalty obligation

                               

Pass through interest remitted to administrative agent

  $ 4,121     $ 5,403     $ 19,166     $ 20,634  

Non-cash remeasurement adjustment

    736       (4,061 )     (33,435 )     (5,614 )

Interest expense, net of remeasurement on OMIDRIA royalty obligation

    4,857       1,342       (14,269 )     15,020  
                                 

2026 Notes

                               

Contractual interest expense

    224       1,284       2,547       7,772  

Amortization of debt discount and issuance costs

    27       146       287       859  

Interest expense on 2026 Notes

    251       1,430       2,834       8,631  
                                 

Term Loan

                               

Contractual interest expense

    1,299       2,378       8,021       5,525  

Amortization of debt premium and issuance costs

    (852 )     (2,022 )     (5,578 )     (4,681 )

Interest expense on Term Loan

    447       356       2,443       844  
                                 

2029 Notes

                               

Contractual interest expense

    1,681             4,220        

Amortization of debt discount and issuance costs

    1,452             3,658        

Interest expense on 2029 Notes

    3,133             7,878        
                                 

Finance leases and other

    38       49       154       180  
                                 

Total interest expense, net of remeasurement adjustments and other

  $ 8,726     $ 3,177     $ (960 )   $ 24,675  

 

 

 

 

OMEROS CORPORATION

 

UNAUDITED GAAP TO NONGAAP RECONCILIATION

 

(In thousands)

 

 

   

Three Months Ended

   

Twelve Months Ended

 
   

December 31, 2025

 

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

               
                 

Numerator (in thousands)

               

Net income (loss)

  $ 86,451     $ (3,350 )

Less: remeasurement of fair value of financial instruments

    136,038       136,717  
                 

Non-GAAP adjusted net income

  $ 222,489     $ 133,367  
                 

Denominator (in shares)

               

Basic weighted average shares

    70,829,424       63,510,201  
                 

Net income (loss) per share basic

  $ 1.22     $ (0.05 )
                 

Non-GAAP adjusted net income per share basic

  $ 3.14     $ 2.10  

 

 

FAQ

How did Omeros (OMER) perform financially in Q4 2025?

Omeros reported Q4 2025 net income of $86.5 million, or $1.22 per share, versus a net loss of $31.4 million, or $0.54 per share, in Q4 2024. Results were driven mainly by a $237.6 million gain from the zaltenibart sale to Novo Nordisk.

What were Omeros’ full-year 2025 results compared to 2024?

For 2025, Omeros posted a net loss of $3.4 million, or $0.05 per share, compared with a loss of $156.8 million, or $2.70 per share, in 2024. Non-GAAP adjusted net income for 2025 was $133.4 million, or $2.10 per share.

What is the significance of Omeros’ deal with Novo Nordisk?

Omeros sold global rights to zaltenibart to Novo Nordisk, receiving $240.0 million in upfront cash and recognizing a $237.6 million net gain. The company may also earn up to $510.0 million in development and approval milestones, $1.3 billion in sales-based milestones, and tiered royalties.

Which new drug did Omeros get FDA approval for in 2025?

The FDA approved YARTEMLEA (narsoplimab-wuug) on December 23, 2025, for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy in adults and children aged two and older. Commercial sales began in January 2026, making it the first approved therapy for TA-TMA.

How did Omeros’ debt and cash position change by year-end 2025?

At December 31, 2025, Omeros had $171.8 million in cash and short-term investments and $87.9 million in aggregate principal debt. Debt fell by $77.1 million from $164.9 million a year earlier after repaying its senior secured term loan and 2026 convertible notes.

What were Omeros’ operating expenses in 2025 versus 2024?

Total operating expenses were $122.8 million in 2025, down from $167.0 million in 2024. The $44.2 million decrease mainly reflected prior-year drug substance releases, completed OMS1029 and IgA nephropathy work, and reduced spending to conserve capital ahead of the YARTEMLEA launch.

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