FDA Approval and First-to-Market Position for YARTEMLEA
YARTEMLEA (MASP-2 inhibitor) received FDA approval for TA-TMA, making it the first and only approved treatment for this indication and the first approved inhibitor of the lectin pathway of complement. Launched in January with initial shipments mid-month and first sales shortly thereafter.
Strong Early Commercial Performance
First-quarter 2026 YARTEMLEA gross revenues were $11.1 million and net revenues were $9.9 million (gross-to-net adjustments ~11%). Early demand and uptake described as strong: 30 unique accounts had ordered by March 31 and 6 of the top 10 and 24 of the top 80 transplant centers had ordered by quarter-end. Distributor delivery occurs within ~24 hours and distributors carry ~1–1.5 weeks of inventory.
Product Achieved Cash Flow Positive Quickly
YARTEMLEA became cash flow positive in Q1 2026 despite a mid-January launch, and management expects the product to drive company-wide positive cash flow within 18 months.
Significant Non-Dilutive Capital from Novo Nordisk Transaction
At close, Omeros received $240 million upfront from Novo Nordisk for zaltenibart and is eligible for an additional $100 million in near-term milestones. The transaction is valued at up to $2.1 billion in upfront and milestones plus royalties in the high single digit to high-teen range, providing substantial funding for operations and the YARTEMLEA launch.
Healthy Cash Position and Share Repurchase
Ended Q1 with $135.3 million in cash and investments after retiring remaining 2026 notes. Repurchased and retired ~360,000 shares at an average price of $11.70 (~$4.2 million) during the quarter.
Regulatory and Reimbursement Milestones to Improve Access
CMS assigned a permanent J-code for YARTEMLEA effective July 1 (simplifies billing). CMS proposed the New Technology Add-On Payment (NTAP) for YARTEMLEA in the IPPS proposed rule; final decision expected in August with NTAP effective Oct 1, which should improve inpatient reimbursement and access.
International and Label Expansion Opportunities
Marketing authorization application for YARTEMLEA under review by EMA with expectation of a midyear decision. Management is evaluating ex-U.S. partnerships and additional indications (e.g., ARDS, sickle cell, acute kidney injury, solid organ transplant-related TMA, delayed graft function).
Robust Pipeline and Scientific Recognition
Progress across multiple programs: Phase II–ready long-acting MASP-2 antibody (OMS1029) and oral MASP-2 small-molecule program moving toward IND-enabling studies; OMS527 (PDE7) fully funded by NIDA with inpatient human study targeted by year-end; T-CAT platform work presented at ESCMID and accepted for publication in Science Translational Medicine; OncotoX-AML shows strong preclinical efficacy and IND-enabling work underway targeting first-in-human in late 2027.