Omeros NASDAQ: OMER reported second-quarter net sales of $28.5 million for YARTEMLEA, its newly launched treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, as the company generated positive operating cash flow and reduced its convertible debt after the quarter ended.
YARTEMLEA produced $32.2 million in gross sales during the quarter, its first full quarter on the market, and $28.5 million in net sales after gross-to-net adjustments of 11.5%. Gross sales rose 190% from the first quarter, while net sales increased 188%.
The FDA approved YARTEMLEA in December 2025 for TA-TMA, a potentially fatal complication of stem cell transplantation. Omeros launched the product in mid-January. Chairman and CEO Gregory Demopulos said the product is the first approved treatment for TA-TMA and the first approved inhibitor of the lectin pathway of complement.
Launch Adoption and Reimbursement Progress
Omeros said its sales organization is engaging all 175 U.S. transplant centers. As of June 30, 73 unique accounts had ordered YARTEMLEA, up 143% from March 31. Adult patients accounted for approximately 75% of second-quarter YARTEMLEA sales as use at adult transplant centers grew at more than twice the rate of pediatric utilization.
The company said YARTEMLEA had received Pharmacy and Therapeutics committee approval at approximately 55% to 60% of the top 10, 20, 40 and 80 U.S. transplant-center cohorts it tracks. Omeros also reported that ordering frequency increased during the quarter.
On the reimbursement front, the Centers for Medicare & Medicaid Services assigned YARTEMLEA a permanent product-specific HCPCS J-code effective July 1. CMS also granted a new technology add-on payment, or NTAP, for the drug in its final fiscal 2027 inpatient prospective payment system rule. The NTAP, expected to take effect Oct. 1, provides up to $287,000 in additional Medicare reimbursement for inpatient treatment with YARTEMLEA.
Demopulos said Medicare beneficiaries represent about 30% of U.S. allogeneic transplant recipients. The company added that commercial prior authorization requests have been approved consistently and that it is preparing health economics and outcomes research analyses for scientific meetings and peer-reviewed publication.
During the question-and-answer session, Demopulos said distributor inventory has remained at about 1.5 weeks of supply since the first quarter and said second-quarter sales did not reflect channel stocking. Chief Commercial Officer Bill Woodman said Omeros expects use to shift toward earlier diagnosis and treatment over time, potentially allowing treatment before patients become severely ill.
Financial Results and Capital Structure
Omeros reported second-quarter net income of $13.2 million, or $0.18 per share, compared with net income of $56.1 million, or $0.78 per share, in the first quarter. The results included a $12.1 million non-cash mark-to-market gain on the embedded derivative associated with the company’s 2029 convertible notes.
Excluding non-cash remeasurements of embedded derivatives and other financial instruments, non-GAAP adjusted net income 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, in the first quarter.
The company ended June with $132 million in cash and investments and generated $4.1 million in net cash from operations during the quarter. David Borges, Omeros’ chief accounting officer, said total operating expenses from continuing operations before interest and other income were $28.5 million, up $1.1 million sequentially.
Omeros repurchased and retired approximately 489,000 common shares during the second quarter for $5.7 million, at an average price of $11.70 per share. Through June 30, the company had repurchased about 843,000 shares for $9.9 million.
In June and July, Omeros entered agreements to repurchase $30.5 million aggregate principal amount of its 9.5% convertible notes due in 2029. The transactions closed in July for an aggregate purchase price of $60.2 million plus accrued interest, reducing outstanding principal by about 43%, from $70.8 million to $40.3 million. The repurchases also reduced shares issuable upon conversion from about 11.4 million to 6.5 million.
For the third quarter, Borges said operating expenses are expected to be slightly higher than the second quarter, driven by increased spending on the OMS805 oncology program and continued investment in YARTEMLEA commercial activities. Omeros is not providing revenue guidance, citing the need for additional experience with prescribing trends, patient demand and market dynamics.
Pipeline and European Review
In Europe, Omeros said the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a negative opinion in June on the company’s marketing authorization application for YARTEMLEA in TA-TMA. Omeros has requested a re-examination of the application. The review will include an Ad Hoc Expert Group of external specialists and new rapporteurs.
The company said it continues to provide YARTEMLEA to European patients through an expanded access program, prioritizing children. It also plans to begin enrollment by year-end in two investigator-sponsored, Omeros-supported studies: one in hyperinflammatory acute respiratory distress syndrome and another evaluating prophylactic use in pediatric patients with predictably severe TA-TMA.
Beyond YARTEMLEA, Omeros is advancing OMS1029, a long-acting MASP-2 antibody that is phase II-ready, and an oral small-molecule MASP-2 inhibitor program. The company is also conducting non-clinical work for OMS527, its PDE7 inhibitor for cocaine use disorder, and expects to begin enrollment in an inpatient clinical study by year-end.
Omeros said it is preparing a first-in-human study of OMS805, also called OncotoX-AML, for late 2027. The engineered biologic is being developed for acute myeloid leukemia, and IND-enabling studies are underway.
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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