Detailed narrative
YARTEMLEA Commercial Progress
YARTEMLEA, the first and only approved treatment for TA-TMA, generated $32.2 million in gross sales and $28.5 million in net sales in its first full quarter, representing 190% and 188% increases respectively from Q1. The launch focuses on educating transplant teams, securing institutional access, ensuring timely reimbursement, and demonstrating economic value. Adult utilization grew significantly, now comprising approximately 75% of YARTEMLEA sales, approaching the historical 85%/15% adult/pediatric transplant split.
Capital Structure Enhancement
Omeros repurchased approximately 843,000 shares of common stock year-to-date at an average price of $11.70 per share. Additionally, $30.5 million aggregate principal amount of 9.5% convertible notes due 2029 were repurchased, reducing outstanding principal by 43% to $40.3 million and the number of shares issuable upon conversion from 11.4 million to 6.5 million. These actions reduced the potential fully diluted share count by 5.8 million shares year-to-date.
Reimbursement Milestones
CMS assigned YARTEMLEA a permanent, product-specific HCPCS J-code effective July 1, streamlining outpatient reimbursement. CMS also granted a New Technology Add-on Payment (NTAP) of up to $287,000 for inpatient treatment with YARTEMLEA, effective October 1, which is crucial as Medicare beneficiaries represent about 30% of allogeneic transplant recipients. Commercial payer experience remains positive with consistent prior authorization approvals.
European Regulatory Update
The European Medicines Agency's CHMP adopted a negative opinion on YARTEMLEA's marketing authorization application for TA-TMA, despite the same clinical evidence supporting FDA approval. Omeros has requested re-examination, which will involve an Ad Hoc Expert Group review and new rapporteurs. The company continues to provide YARTEMLEA to European patients through an expanded access program.
Pipeline Expansion and Other Programs
Omeros is pursuing YARTEMLEA label expansion into other MASP-2 driven indications like chemotherapy-induced TMA and ARDS, with two investigator-sponsored studies expected to begin enrollment by year-end. The broader MASP-2 platform includes a Phase 2-ready long-acting antibody (OMS1029) and an oral small molecule inhibitor program for chronic indications. Beyond complement, the PDE7 inhibitor OMS527 for cocaine use disorder is advancing, and the T-CAT platform for multidrug-resistant infections showed promising preclinical data. The oncology program's lead asset, OncotoX-AML (OMS805), is preparing for a first-in-human trial in late 2027.
Novo Nordisk Collaboration
The collaboration continues smoothly, with Omeros having received $240 million upfront cash in Q4 2025 and eligible for up to an additional $100 million in near-term milestone payments. Omeros continues to provide transition services to Novo Nordisk.