Omeros (NASDAQ:OMER) executives highlighted two “major successes” in the fourth quarter of 2025 that they said marked a turning point for the company: closing a $240 million upfront asset sale and license deal with Novo Nordisk for the phase III-ready complement asset zaltenibart, and receiving FDA approval for narsoplimab—now marketed as YARTEMLEA—as the first approved treatment for transplant-associated thrombotic microangiopathy (TA-TMA).
Novo Nordisk deal for zaltenibart brings upfront cash and potential milestones
Chairman and CEO Greg Demopulos said Omeros closed its previously announced transaction with Novo Nordisk on Nov. 25, granting Novo Nordisk “exclusive global rights to develop and commercialize zaltenibart,” a human monoclonal antibody targeting MASP-3. Demopulos described MASP-3 as “the key activator” and “the premier target of the alternative pathway of complement.”
Demopulos noted that Omeros retained rights to its MASP-3 small molecule program across multiple therapeutic areas and also retained rights to certain “grandfathered MASP-3 antibodies” with restrictions. The company also entered into a transition services agreement (TSA) to support transfer of the program, with Novo Nordisk reimbursing Omeros for employee costs and other expenses associated with maintaining studies and program operations, as well as reimbursement for inventories of drug substance and drug product.
In the Q&A, Demopulos said the company could not disclose the specific triggers for the $100 million near-term milestones due to agreement terms, but said management’s “level of confidence is high” in receiving them, while noting the company could not guarantee outcomes.
FDA approval and early U.S. launch of YARTEMLEA for TA-TMA
Omeros’ second milestone came Dec. 23 with FDA approval of YARTEMLEA for the treatment of TA-TMA in adults and children at least 2 years of age. Demopulos said the approval is broad and makes YARTEMLEA “the first and only approved treatment for TA-TMA.”
Demopulos contrasted the MASP-2 inhibitor with off-label complement inhibition approaches, stating that by blocking upstream MASP-2, YARTEMLEA preserves infection-fighting functions of other complement pathways. He emphasized that the approved label carries “none of the safety-related obligations usually required for complement inhibitors,” specifically citing no boxed warning, no REMS program, and no required vaccinations.
Chief Commercial Officer Nadia Dac and Demopulos said the company prepared for launch ahead of approval, hiring and deploying a full field force. Demopulos reported the company supplied distributors within the first three weeks of January, with “first sales” occurring shortly thereafter. He said patients are now receiving YARTEMLEA within 24 hours of placing an order, including patients who have “recently failed prior off-label C5 or C3 inhibitor regimens.” Omeros also reported that third-party payer reimbursement has been received.
On pricing, Demopulos said the per-vial price is approximately $36,000 and each vial is a single dose. Median utilization across the pivotal trial and expanded access program was “8-10 vials per treatment course,” he said, adding the company expects most of the course to be administered in hospital outpatient departments where the hospital purchases and bills for the drug.
Formulary access and payer coverage: early progress and ongoing education push
Management said its commercial focus is on 80 high-volume transplant centers representing about 80% of annual U.S. stem cell transplants, while also expanding education more broadly. Demopulos said the field force has detailed centers representing “nearly 90% of the allogeneic stem cell transplant procedures performed nationally.”
Omeros outlined four early launch objectives:
- Educate transplant teams on harmonized TA-TMA diagnostic criteria to drive awareness, early diagnosis, and treatment.
- Support rapid Pharmacy and Therapeutics (P&T) approvals, formulary addition, and ordering processes.
- Work with payers to ensure timely reimbursement consistent with the label and published criteria.
- Finalize and publish health economics and outcomes research (HEOR) analyses supporting cost-effectiveness.
Demopulos said P&T progress “has exceeded our expectations,” reporting formulary placement at approximately:
- 50% of the top 10 U.S. transplant centers
- 40% of the top 20 centers
- 35% of the top 40 centers
- ~30% of the top 80 centers
In the Q&A, Dac added that in centers where P&T approvals are still pending, the lack of approval “is not standing in the way of getting YARTEMLEA to the patients,” and the company is seeing hospital use even without finalized formulary status.
On payer coverage, Dac said pre-authorization approvals have been achieved through both published payer policies and medical exceptions. She characterized the early policies as “PA to label,” and said that where published policies are not yet available, medical exceptions are also being handled consistent with the label.
When asked about early real-world dosing patterns, Demopulos said Omeros is seeing both once-weekly and twice-weekly dosing, estimating a 70% once-weekly / 30% twice-weekly split, with twice-weekly dosing more common in pediatric patients. He said he expects the mix to shift “more heavily toward twice weekly dosing” as education progresses, noting that twice-weekly dosing is allowed under the label and that payers have not been restricting it based on early policies.
Demopulos also pointed to the company’s forthcoming HEOR work as part of its value narrative, telling analysts the results “strongly support YARTEMLEA’s clinical, economic, and real-world value” and that publication is planned “soon.” In response to a question about the broader costs involved, Demopulos said overall transplant costs and related costs “run about $1 million,” and he referenced published literature suggesting increased infection risks with C5 inhibition used off-label in TA-TMA.
Financial results: Q4 net income driven by transaction gain; debt reduced
For the fourth quarter of 2025, Omeros reported net income of $86.5 million, or $1.22 per share, compared with a third-quarter net loss of $30.9 million, or a loss of $0.47 per share. Chief Accounting Officer David Borges said results included a $237.6 million net gain on the sale of zaltenibart (reflecting the $240 million upfront payment less $2.4 million in transaction costs).
Results also included a $136 million non-cash charge related to a mark-to-market adjustment on embedded derivatives tied to the company’s 2029 convertible notes and term loan. Excluding that charge, Borges said non-GAAP adjusted net income was $222.5 million, or $3.14 per share.
Omeros ended 2025 with $171.8 million in cash and investments, up $135.7 million from Sept. 30, 2025. Management also emphasized balance sheet actions funded in part by the Novo Nordisk upfront payment:
- Full repayment of a $67.1 million secured term loan in November 2025, eliminating related liens and covenants.
- Repayment at maturity in February 2026 of the remaining $17.1 million principal balance on 2026 convertible notes.
Following those repayments, Borges said the company’s only remaining debt is $70.8 million in principal amount of unsecured 2029 convertible notes due in June 2029.
Looking ahead, Borges said Omeros expects first-quarter 2026 operating expenses from continuing operations to be comparable to fourth-quarter 2025 levels, with R&D expected to be lower due to reimbursement of zaltenibart-related expenses under the TSA, while sales and marketing expenses are expected to increase due to YARTEMLEA launch activities. The company said it is not providing revenue guidance yet because YARTEMLEA is in the early stages of launch.
Demopulos said the company anticipates the “YARTEMLEA program will be financially self-sustaining this year,” and he reiterated a target for the company to achieve “positive cash flow in 2027.”
Pipeline updates: complement expansion, TCAT anti-infective platform, and oncology program
Beyond YARTEMLEA, Demopulos said Omeros is evaluating expansion opportunities for the MASP-2 inhibitor in other endothelial injury-related disorders, including acute respiratory distress syndrome (ARDS) and solid organ transplant-related TMA. He also said the company intends to advance OMS1029, a “once quarterly dosed MASP-2 antibody” described as phase II-ready, as well as a MASP-2 small molecule program designed for once-daily oral administration, aimed at chronic indications including nephrology and neurology.
In other programs, Demopulos said the company’s PDE7 inhibitor OMS 527 for cocaine use disorder is fully funded by a National Institute on Drug Abuse (NIDA) grant, with animal cocaine interaction studies completed and showing no drug interaction or safety issues; he said the FDA requested additional preclinical information before an inpatient human study, and Omeros and NIDA plan to meet with the FDA in the coming quarter.
He also highlighted progress in the company’s targeted complement activating therapy (TCAT) platform against multidrug-resistant organisms, stating that patents have been filed and a publication is expected in the coming weeks. In oncology, Demopulos said IND-enabling studies are underway for OncotoX-AML, and that Omeros is designing its first-in-human clinical trial targeted for late next year.
Closing the call, Demopulos said “2025 ended strong, and 2026 has continued that momentum,” adding that the company plans to provide more detailed YARTEMLEA launch updates on its first-quarter 2026 earnings call in about six weeks.
About Omeros (NASDAQ:OMER)
Omeros Corporation is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of small-molecule and protein therapeutics. The company’s research programs target inflammation, complement-mediated diseases and disorders of the central nervous system. Omeros’s portfolio encompasses both internally discovered molecules and biologics, reflecting its commitment to advancing treatments for conditions with high unmet medical need.
Omeros’s first FDA-approved product, Omidria® (phenylephrine and ketorolac intraocular solution), is indicated to maintain pupil size by preventing intraoperative miosis and reducing postoperative pain in patients undergoing cataract surgery.
