Omeros (NASDAQ:OMER) reported first-quarter 2026 net income of $56.1 million, or $0.78 per share, as the company began commercial sales of YARTEMLEA, its recently approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA.
Chairman and Chief Executive Officer Dr. Gregory Demopulos said YARTEMLEA generated gross revenue of $11.1 million and net revenue of $9.9 million in the quarter, reflecting gross-to-net adjustments of about 11%. The product launched in January, with initial shipments to distributors beginning in mid-month.
Demopulos said early demand and uptake were “strong” and that YARTEMLEA became cash flow positive in the first quarter despite the mid-January launch. He said the company expects the drug to drive company-wide positive cash flow within 18 months.
YARTEMLEA Launch Gains Early Access Momentum
YARTEMLEA was approved by the U.S. Food and Drug Administration as the first and only approved treatment for TA-TMA and the first approved inhibitor of the lectin pathway of complement, according to Demopulos. Omeros is focusing the launch on educating transplant teams, securing hospital Pharmacy and Therapeutics committee approvals, ensuring reimbursement and supporting pricing through health economics and outcomes research.
Demopulos said the company’s field force is detailing all 175 transplant centers nationwide. By March 31, 30 unique accounts had ordered YARTEMLEA. He added that six of the top 10 transplant sites and 24 of the top 80 centers had ordered the drug by the end of the quarter.
The company said hospital formulary progress has been faster than expected, despite what Demopulos described as a typical six- to nine-month timeline for P&T committee approvals. By quarter end, Omeros understood that 60% of the top 10 centers, 40% of the top 20, 38% of the top 40 and about 30% of the top 80 U.S. centers had received P&T committee approval.
On reimbursement, Demopulos said all prior authorization requests submitted to third-party commercial payers to date had been approved and that centers had begun receiving full payment. He also said the U.S. Centers for Medicare & Medicaid Services assigned a permanent Healthcare Common Procedure Coding System J-code for YARTEMLEA in April, effective July 1. CMS also recommended approval of a New Technology Add-on Payment, or NTAP, in its inpatient prospective payment system proposed rule, with a final rule expected in August.
During the question-and-answer session, Demopulos said distributors deliver YARTEMLEA to sites within about 24 hours of receiving a request. He said distributor inventory has averaged about one and a half weeks, and that centers generally carry relatively small inventories because of the short delivery timeline.
Asked about patient mix, Demopulos said the overall TA-TMA population is roughly 85% adult and 15% pediatric, but that early YARTEMLEA use has included a higher percentage of pediatric patients than that split would suggest. He cautioned that the company has only slightly more than two months of launch data.
First-Quarter Results Include Large Non-Cash Gain
Chief Accounting Officer David Borges said the first-quarter profit included a $73.1 million non-cash gain tied to the mark-to-market adjustment on the embedded derivative associated with Omeros’ 2029 convertible notes. Excluding that item, non-GAAP adjusted net loss was $17.1 million, or $0.24 per share.
Omeros ended the quarter with $135.3 million in cash and investments. Borges said the company repaid the remaining $17.1 million principal amount of its 2026 notes at maturity in February. Its only remaining debt is $70.8 million of principal outstanding on unsecured 2029 convertible notes due in June 2029.
During the quarter, the company repurchased and retired about 360,000 shares of common stock at an average price of $11.70 per share, for a total of $4.2 million.
Costs and expenses from continuing operations before interest and other income were $27.3 million, down $1.8 million from the fourth quarter of 2025. Interest expense was $5.9 million. Borges said contractual cash interest expense, excluding certain royalty obligation and non-cash debt costs, was $1.8 million compared with $3.2 million in the prior quarter, primarily due to repayment of a secured term loan in November 2025.
For the second quarter, Borges said Omeros expects overall operating expenses from continuing operations to be slightly higher than in the first quarter, reflecting sales, marketing and commercial launch activity for YARTEMLEA. The company is not providing YARTEMLEA revenue guidance at this stage of launch.
Novo Nordisk Deal Supports Balance Sheet
Demopulos said Omeros entered 2026 with two major catalysts: the closing of its previously announced transaction with Novo Nordisk for zaltenibart, its investigational MASP-3 inhibitor, and FDA approval of YARTEMLEA.
At closing of the Novo Nordisk transaction, Omeros received $240 million in upfront cash. The company is also eligible for another $100 million in near-term milestone payments. Demopulos said the deal is valued at up to $2.1 billion in upfront and milestone payments, plus royalties in the high single-digit to high-teen range.
Pipeline Updates Include Complement, Addiction and Oncology Programs
Omeros said its marketing authorization application for YARTEMLEA in TA-TMA remains under review by the European Medicines Agency, with a decision expected around mid-year. The company is evaluating potential partnerships for commercialization outside the United States.
Demopulos said Omeros is assessing YARTEMLEA expansion opportunities in conditions involving lectin pathway activation, including acute respiratory distress syndrome, sickle cell disease, acute kidney injury, solid organ transplant-related TMA and delayed graft function.
The company is also advancing other MASP-2 programs, including OMS1029, a long-acting antibody described as phase 2-ready, and an oral MASP-2 small molecule program. Demopulos said the company is finalizing the initial phase 2 indication for once-quarterly OMS1029 and working to advance the oral program toward IND-enabling studies.
Beyond complement, Demopulos said the company’s PDE7 inhibitor OMS527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse. Omeros and NIDA recently met with the FDA about additional non-clinical information requested before a planned inpatient study in cocaine users, which the company is targeting to start by year-end.
Demopulos also highlighted progress in Omeros’ targeted complement activating therapy platform, which is designed to target and kill pathogens including multidrug-resistant organisms, and said a manuscript describing the technology had been accepted for publication in Science Translational Medicine.
In oncology, Omeros said IND-enabling studies are underway for OncotoX-AML, an engineered biologic agent being developed for acute myeloid leukemia. Demopulos said the company is preparing for a first-in-human trial targeted for late 2027.
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.
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