Omeros Corporation Q3 FY2025 earnings call

• Third quarter net loss was $30.9 million, with noncash charges of $8.8 million from debt derivatives.
• Closed a registered direct offering for $20.3 million and ATM program for $9 million.
• Announced a definitive agreement with Novo Nordisk for $240 million upfront, to repay debt and fund Yartemlia launch.
• BLA for narsoplimab (Yartemlia) for TATMA is under FDA review with PDUFA date December 26, 2025; MAA in Europe under EMA review.
• Publications support Yartemlia's survival outcomes and safety.
• Other programs: PDE7 inhibitor program progressing, TCAT platform for infectious diseases, oncology program advancing.

In the third quarter of 2025, Omeros Corporation reported a net loss of $30.9 million or $0.47 per share, compared to a net loss of $25.4 million or $0.43 per share in the second quarter. The results included $8.8 million in noncash charges from a mark-to-market adjustment of embedded derivatives related to debt. Excluding this charge, the adjusted net loss was $22.1 million. Cash burn for the quarter was $22 million, and as of September 30, cash and investments stood at $36.1 million. The company closed a registered direct offering generating $20.3 million in net proceeds. The deal with Novo Nordisk, valued at up to $2.1 billion, includes $240 million upfront cash with additional milestones, which will be used to repay debt and fund operations, including the US launch of narsoplimab for TATMA.

• Anticipate closing the Novo Nordisk deal this quarter, receiving $240 million upfront.
• Intend to use upfront cash to fully repay secured term loan and 2026 convertible notes, fund over twelve months of operations.
• Expect to be cash flow positive in 2027 with Yartemlia launch and Novo deal benefits.

• Regulatory risks related to FDA and EMA approvals for Yartemlia.
• Uncertainties in debt repayment and cash flow management.
• Impact of government shutdowns on regulatory timelines (though PDUFA for Yartemlia not affected).

Q: About narsoplimab launch post-approval.

A: Launch preparations underway; prioritized accounts with existing champions, formulary approvals parallel to administration.

Q: NTAP for Yartemlia.

A: Applying for NTAP to assist hospital payments, expect approval.

Q: FDA labeling discussions for Yartemlia.

A: Interactions with FDA are collaborative, but specific labeling details not discussed; data includes adult and pediatric patients.

Q: Risks related to historical controls in Yartemlia data.

A: Kyoto data overlap with trial patients, but communications with FDA have been interactive.