Omeros' Q3 2025: Contradictions Emerge on Narsoplimab Launch Timelines, Fda Review, and Financial Strategy

Date of Call: None provided

Financials Results

• EPS: $0.47 loss per share (net loss $30.9M), compared to net loss of $25.4M, or $0.43 per share, in Q2; adjusted loss per share $0.34 excluding an $8.8M non‑cash embedded-derivative charge.

Guidance:

• Operating expenses for Q4 2025 expected to be higher than Q3, primarily due to increased marketing costs for the anticipated Yartemlya launch.
• Research & development expenses expected to be consistent with Q3 levels.
• Interest income slightly higher; other income expected significantly higher reflecting the expected gain on the Novo transaction.
• Expect to record a non-cash gain upon term-loan repayment; cash interest expense (excluding non-cash items) ~ $8M in Q4.
• Income from discontinued operations expected in the $5–6M range (excluding non-cash remeasurements).

Business Commentary:

• Financial Performance and Capital Raise:
• Omeros reported a net loss of $30.9 million for Q3, excluding a $8.8 million non-cash charge. The company raised $20.3 million in net proceeds from a registered direct offering.

• The loss was primarily due to non-cash charges related to embedded derivatives, while the capital raise supports ongoing operations and commercial launch preparations.

• Strategic Transaction with Novo Nordisk:

• Omeros entered into a definitive agreement with Novo Nordisk for an asset purchase and license transaction centered on MASP-3 antibody, Zaltenibart, valuing it at up to $2.1 billion.

• The transaction, expected to close in late Q4, brings in $240 million in upfront cash and validates the scientific and clinical potential of Omeros' complement franchise.

• Regulatory and Commercial Launch Preparations:

• Omeros' BLA for narsoplimab, marketed as Yartemlya for TATMA, is under FDA review, with a PDUFA date in December 2025.

• U.S. commercial preparation is underway, including assembling a launch-ready team, securing ICD-10 diagnostic and CPT procedural codes, and seeking an NTAP from CMS.

• Pipeline Advancements:

• OMS 1029, a long-acting MASP-2 antibody, is phase two ready, and the lead small molecule MASP-2 inhibitor is nearing IND-enabling studies.

• The PDE7 inhibitor program for cocaine use disorder, funded by the National Institute on Drug Abuse, is progressing towards an inpatient human study in 2026.

• Operational and Debt Management:

• Cash burn for Q3 was $22 million, with $36.1 million in cash and investments as of September 30.
• Omeros has been working to strengthen its balance sheet, with plans to repay all secured and unsecured debt upon closing the Novo Nordisk transaction.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management called the Novo Nordisk agreement a "strategic and financial milestone," expects $240M upfront to enable >12 months of operations and a planned U.S. launch of narsoplimab (Yartemlya), and said they are "launch-ready" and "optimistic" for FDA approval by or before Dec 26, 2025.

Q&A:

• Question from Brandon Folkes (HC Wainwright): Post-approval timing for launch of narsoplimab (Yartemlya); need for guidelines before launch; ability to detail at launch; selling to transplant centers vs hospitals; formulary/process implications?
  Response: Company is launch-ready and will move quickly upon approval; hospitals can order/administer via exception processes without prior formulary approval, and they expect potential cash-flow positivity in 2027.

• Question from Steve Brozak (WBB Securities): Can you provide more detail on the expected NTAP (new technology add-on payment) for Yartemlya and how it will work/timeline?
  Response: They expect to receive NTAP, submitted on time; will present at CMS town hall in December and expect any positive decision to take effect in FY2026 to aid hospital reimbursement.

• Question from Olivia Breyer (Cantor): Have you had labeling discussions with FDA; is there anything to consider for potential label given historical control analysis; why Kyoto Transplantation Group data cover 2000–2016 and not beyond?
  Response: They will not discuss play‑by‑play FDA labeling negotiations, emphasize FDA interactions have been collaborative, state Kyoto data are high-quality, published patient-level datasets covering 17 institutions (hence the timeframe), and they aim to include adult and pediatric data in any label.

• Question from John for Serge Bellinger (Needham & Co.): Any recent FDA commentary on historical controls given recent CRLs for other products using historical controls; outlook for operating expenses heading into 2026 after the Q4 bump?
  Response: They view routine FDA information requests as normal, believe their historical-control package differs materially from other CRL cases and poses no meaningful risk, and expect operating spend to increase in 2026 (scalable up/down) contingent on Novo closing and FDA approval to support multiple programs and the launch.

Contradiction Point 1

Launch Timeline for Narsoplimab

It involves the expected timeline for the launch of a critical product post-approval, which is crucial for revenue projections and investor expectations.

When and how will you launch narsoplimab post-approval? Will you follow guidelines for its sale to transplant centers, and what is the process? - Brandon Folkes (HC Wainwright)

2025Q3: Launch preparations are underway, and upon approval, a quick launch is expected. Revenue projections aren't discussed immediately post-approval. Launch will not follow specific guidelines, and ready accounts will be prioritized. - Greg Demopulos(CEO)

How long to launch if approved in December? Was inventory built as in the past for narsoplimab? - Brandon Folkes (H.C. Wainwright)

2025Q2: If approved in December, the launch is expected in the first quarter of the following year. - Gregory Demopulos(CEO)

Contradiction Point 2

FDA Interactions and Review Process

It involves the nature of interactions with the FDA and the potential impact on the review process, which could influence regulatory milestones and product launch timelines.

Has the FDA recently commented on your data package, particularly historical controls? What is your operating expenses outlook for 2026? - John (Needham & Co.)

2025Q3: FDA interactions are standard, with timely responses to information requests. Our application differs from recent CRLs. - Greg Demopulos(CEO)

What caused the 3-month PDUFA delay, and did the FDA make any unexpected requests? - Olivia Brayer (Cantor)

2025Q2: The delay was due to additional analyses requested by the FDA. The interactions have been collaborative, and the company continues to work with the FDA to potentially expedite the review process. - Gregory Demopulos(CEO)

Contradiction Point 3

Launch Preparations and Timing

It concerns the company's plans and preparedness for launching a key product, which impacts expectations for revenue generation and market penetration.

When and how will you launch narsoplimab after approval? Do you need to follow guidelines, and what is the sales process for transplant centers? - Brandon Folkes(HC Wainwright)

2025Q3: Launch preparations are underway, and upon approval, a quick launch is expected. - Greg Demopulos(CEO)

Can you provide detail on launch plans and preparedness? What does this mean for patient access? - Stephen Brozak(WBB Securities)

2025Q1: Narsoplimab is expected to be the first approved therapy in TA-TMA, a $1 billion opportunity, and we are preparing for its launch with its potential impact on the transplant market. - Gregory Demopulos(CEO)

Contradiction Point 4

Financial Strategy and Capital Management

It involves changes in financial strategy and capital management, which are crucial for investor confidence and the company's financial sustainability.

Have you discussed labeling with the FDA? Should we consider anything about the potential label based on historical control analysis? - Olivia Breyer(Cantor)

2025Q3: We have an active at-the-market facility to raise up to $150 million, providing flexibility for capital needs. We are managing our cash and liquidity carefully and are focused on delivering on our priorities, allocating resources wisely. - Greg Demopulos(CEO)

Explain your capital strategy and approach to addressing financial challenges? - Stephen Brozak(WBB Securities)

2025Q1: We have strengthened our balance sheet by exchanging $71 million in 2026 convertible notes for new 2029 notes and converting $10 million into equity. This reduces our total debt and near-term repayment obligations. - Gregory Demopulos(CEO)

Contradiction Point 5

Launch Strategy and Partnership

It involves the company's strategic approach to launching and partnering for narsoplimab, which could impact market access and revenue.

When will you launch narsoplimab after approval, and how? Do guidelines apply, and what is the sales process for transplant centers? - Brandon Folkes (HC Wainwright)

2025Q3: Launch preparations are underway, and upon approval, a quick launch is expected. Revenue projections aren't discussed immediately post-approval. - Greg Demopulos(CEO)

How should we think about Omeros's long-term commercial partnering strategy given its deep pipeline? - Brandon Folkes (Rodman & Renshaw)

2024Q4: We plan to launch narsoplimab independently in the U.S. and partner ex-U.S., considering regional or international agreements. - Gregory Demopulos(CEO)