Omeros Corporation Q2 FY2026 earnings call

• Yartemlia Commercial Launch Execution:

  • Yartemlia is the first and only approved treatment for TA-TMA, and the only approved inhibitor of the complement lectin pathway. It launched in the U.S. in mid-January 2026.
  • As of Q2 end, 73 unique transplant centers had ordered Yartemlia, a 143% increase from the end of Q1. Adult utilization grew more than twice as fast as pediatric utilization, shifting the sales mix to 75% adult, approaching the historical 85%/15% adult/pediatric split for U.S. stem cell transplants.
  • P&T committee approval has been secured at 55-60% of tracked top U.S. transplant center cohorts. CMS granted a new technology add-on payment (NTAP) of up to $287 thousand in additional Medicare reimbursement for inpatient Yartemlia use, effective October 1, 2026, and assigned a permanent J-code for consistent outpatient reimbursement. Commercial payer prior authorization approvals remain consistently positive.
  • Management's four core launch priorities are: 1) Educate transplant teams to recognize and treat TA-TMA earlier to shift from diagnostic exclusion to proactive screening; 2) Secure institutional formulary access and streamlined ordering; 3) Ensure consistent, timely reimbursement; 4) Demonstrate economic value via health economics and outcomes research (HEOR).

• Pipeline and Platform Updates:

  • The CHMP adopted a negative opinion for European Yartemlia marketing authorization; Omeros has requested reexamination supported by the same clinical data that gained FDA approval, and continues to provide Yartemlia to European patients via an expanded access program.
  • Label expansion is prioritized for other MASP-2 driven indications involving endothelial injury and thrombo-inflammation. Two investigator-sponsored, Omeros-supported trials (for hyperinflammatory ARDS and prophylactic use in pediatric severe TA-TMA) are expected to begin enrollment by end of 2026.
  • The MASP-2 platform has two additional programs in development: phase 2-ready long-acting antibody OMS1000 for quarterly dosing in chronic indications, and an oral small molecule MASP-2 inhibitor program targeting once-daily dosing, with a development candidate expected to be selected after one ongoing study completes.
  • The PDE7 inhibitor OMS527 for cocaine use disorder, funded by a NIDA grant, is on track to begin inpatient trial enrollment by end of 2026 after initiating required nonclinical work.
  • The novel TCAT platform for targeting multidrug-resistant pathogens published foundational positive preclinical data in Science Translational Medicine in June 2026.
  • Lead oncology program OMS805 (OncotoX-AML) for acute myeloid leukemia has completed positive nonclinical studies showing efficacy independent of hard-to-treat AML mutations, with IND-enabling studies underway and a first-in-human trial targeted for late 2027.

• Capital Structure Updates:

  • Year-to-date through June 2026, Omeros repurchased and retired 843 thousand common shares at a volume-weighted average price of $11.70 per share. In July 2026, the company repurchased $30.5 million aggregate principal amount of its 2029 convertible notes, reducing outstanding principal by 43% and cutting potential fully diluted share count by 5.8 million year-to-date, while eliminating $8.6 million in future interest payments.
  • Q2 2026 generated $4.1 million in positive operating cash flow, and the company ended the quarter with $132 million in cash and investments.

Omeros has one core commercial product segment as of Q2 2026: Yartemlia (for TA-TMA treatment). In its first full quarter on the market, Yartemlia generated gross revenues of $32.2 million (100% of total gross product revenue) and net revenues of $28.5 million, compared to $11.1 million gross / $9.9 million net in Q1 2026, representing a 190% increase in gross sales and 188% increase in net sales quarter-over-quarter. Gross-to-net adjustments were 11.5%, which remained within management expectations. All other Omeros programs are in pre-commercial clinical or pre-clinical development and do not contribute revenue.

• Omeros does not provide Yartemlia revenue guidance at this time, as management intends to gain additional experience with prescribing trends, patient demand, and market dynamics first.
• Total Q3 2026 operating expenses from continuing operations are expected to be slightly higher than Q2 2026, driven by increased spending on the OMS805 oncology program and continued investment in Yartemlia commercial infrastructure and launch activities.
• Interest and other income are expected to be lower in Q3 2026, as the Q2 2026 Novo Nordisk inventory reimbursement will not recur.
• Q3 2026 interest expense is expected to be approximately $6.5 million, reflecting the reduction in outstanding convertible notes following repurchases.
• Income from discontinued operations is expected to be between $5 million and $6 million, excluding non-cash remeasurement adjustments related to the OMIDRIA royalty contract.
• Management reaffirms its prior guidance that the company will be cash flow positive company-wide by mid-2027.

• Forward-looking statements (including launch adoption, pipeline progress, and cash flow guidance) are subject to risks and uncertainties that could cause actual results to differ materially, detailed in Omeros' recent Form 10-Q and Form 10-K filings with the SEC.
• Non-cash mark-to-market adjustments for the embedded derivative on remaining 2029 convertible notes will continue to be reported, are volatile, driven primarily by Omeros' stock price, and do not affect operating performance or liquidity.
• Paradigm shift for TA-TMA diagnosis and treatment at large academic transplant centers faces institutional inertia, which could slow adoption over the near term.
• The CHMP reexamination process for European Yartemlia marketing authorization carries uncertainty regarding the final regulatory outcome.

Q: Given recent negative trial data for C5 inhibitors (ultomiris/ravulizumab) in TA-TMA, how does off-label C5 inhibitor use impact Yartemlia adoption, and why do any physicians still use C5 inhibitors? / A: There is some continued off-label use of eculizumab (ravulizumab dosing is not well-suited for acute TA-TMA), which management attributes mostly to long-standing physician habit rather than competitive advantage. Yartemlia has a more favorable safety profile than C5 inhibitors: MASP-2 inhibition does not increase infection risk the way C5 inhibition of the classical lytic pathway does. Management does not see this as a meaningful long-term headwind, and the rapid breadth and depth of Yartemlia adoption reflects physician preference for the approved product.

Q: Are Yartemlia's Q2 sales driven by channel stocking, or do they reflect actual patient utilization? How does the NTAP reimbursement process work for Yartemlia? / A: There is no channel stocking: distributor inventories have held steady at ~1.5 weeks of supply since launch, so Q2 sales reflect actual patient utilization. NTAP is a CMS program that adds supplemental reimbursement for new technologies before DRG payment weights are updated to account for the new drug. CMS approved up to $287 thousand in NTAP for Yartemlia, effective October 1 2026, which will support inpatient reimbursement for Medicare beneficiaries, who make up ~30% of U.S. allogeneic transplant recipients.

Q: Do adult patients use a different number of Yartemlia vials per patient compared to pediatric patients? / A: There is no significant difference in vial utilization per patient between adult and pediatric groups. Early in the launch, utilization is higher because the first patients treated tend to be more severe; as diagnosis and treatment shifts earlier, management expects average vial use per patient to decline over time regardless of patient age.

Q: How many patients have been treated with Yartemlia to date, and what is the potential size of the TA-TMA market given the paradigm shift from diagnostic exclusion? / A: Omeros does not have access to specific patient count data due to HIPAA patient confidentiality rules, only vial ordering data. Management notes that prior to Yartemlia approval, TA-TMA was widely treated as a diagnosis of exclusion with inconsistent diagnostic criteria, and the company is just scratching the surface of the current market. Recent data shows TA-TMA incidence as high as 56% of allogeneic transplants, and management expects diagnostic rates and recognized incidence to increase as standardized diagnosis and effective treatment becomes more widely available, with adoption growing gradually as large institutional centers update diagnostic protocols and clinical workflows.