OMEROS CORP (OMER)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 loss narrowed materially: GAAP net loss was $25.4M ($0.43/share) vs $56.0M ($0.97/share) in Q2 2024 and $33.5M ($0.58/share) in Q1 2025, driven by lower OpEx and favorable non-cash items .
• FDA extended the narsoplimab TA‑TMA PDUFA action date to December 26, 2025 after Omeros submitted additional analyses; labeling discussions are planned to begin by October, assuming no major deficiencies .
• Balance sheet de-risked: 2026 converts cut from $97.9M to $17.1M and new 2029 notes issued; eliminated a $20M term-loan prepayment otherwise due by Nov-2025; cash/short-term investments were $28.7M on 6/30/25, plus $20.6M raised 7/28/25 .
• Commercial readiness advancing: phased sales hiring for transplant centers; strong payer engagement; sufficient drug supply for several years upon approval; launch expected in the first quarter following approval .
• Consensus check: Q2 EPS modestly beat S&P Global consensus (−$0.531 actual vs −$0.545 est.) while continuing-ops revenue remained de minimis vs a small consensus ($0.3125M); biotech P&L remains driven by OpEx/financing items rather than revenue this quarter (S&P Global) [GetEstimates].*

What Went Well and What Went Wrong

• What Went Well

  • Debt overhang alleviated: “we significantly improved our balance sheet, reducing our near-term debt by more than $100 million,” and extended maturities via note exchanges/equitization .
  • Regulatory momentum: FDA accepted the BLA resubmission; all requested analyses to date “have been consistent with and have provided statistically significant support of narsoplimab’s benefit,” and labeling talks planned by October if no major deficiencies .
  • Launch readiness/payer receptivity: Omeros is onboarding hematology-experienced sales reps targeting top transplant centers; payers’ pre-approval feedback “has been highly encouraging” . “We have adequate supply for the first several years from launch” .

• What Went Wrong

  • PDUFA delay: FDA extended the action date to December 26, 2025 after Omeros submitted additional analyses; management framed interactions as collaborative, but the three-month delay pushes timing .
  • Lower OMIDRIA economics: Q2 OMIDRIA U.S. sales fell to $28.6M (from $36.4M), with royalties earned falling to $8.6M (from $10.9M). A downward remeasurement reduced OMIDRIA-related income in discontinued ops to $0.5M (from $9.1M) .
  • Tight liquidity and covenant: Cash and short-term investments were $28.7M at 6/30/25 and Omeros must maintain ≥$25M unrestricted cash under its credit agreement, highlighting near-term capital sensitivity despite the July raise .

Financial Results

Financial summary vs prior periods (USD, except per-share):

Key OMIDRIA KPIs (pass-through economics through DRI until 2031):

Notes and drivers:

• Q2 OpEx fell YoY by $26.8M, benefiting from prior-year narsoplimab drug substance manufacturing costs and program pauses to prioritize launch readiness .
• Q2 interest expense was near zero due to a non-cash remeasurement of the DRI royalty obligation (updated Rayner forecasts) .
• Non-cash items included a $3.0M loss on extinguishment of converts and an $8.2M gain on change in fair value of financial instruments .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Working closely with FDA, we continue preparing for the anticipated approval and subsequent launch of narsoplimab in TA‑TMA… To date, all analyses requested by FDA… have been consistent with and have provided statistically significant support of narsoplimab’s benefit” .
• “We significantly improved our balance sheet, reducing our near-term debt by more than $100 million and adding new capital from a long-horizon investor” .
• On payer/physician sentiment: “Feedback has been highly encouraging – stakeholders recognize the strong clinical safety and efficacy data for narsoplimab and are eager for an approved treatment option” .
• On launch/supply: “We have adequate supply for the first several years from launch” and expect to launch in the first quarter after approval .
• Comparative risk: Omeros highlighted data associating off‑label C5 inhibitors with higher infection rates/mortality in pediatric TA‑TMA versus narsoplimab’s mechanism preserving classical pathway lytic function .

Q&A Highlights

• Launch timing and supply: If approved in December, launch would occur the following quarter; inventory is sufficient for “the first several years” .
• PDUFA delay: Triggered by FDA requests for additional analyses; management described interactions as “collaborative” and aims to conclude sooner than Dec 26 if possible .
• Market reception: Physicians “eagerly awaiting” an indicated therapy; payer pre-approval exchanges underway .
• Partnerships: Company reiterated advanced discussions toward a potential multi‑billion total value transaction, with upfront sufficient to retire term loan and remaining converts and fund >12 months of operations .

Estimates Context

Consensus (S&P Global) vs results:

• Q2 2025 EPS modestly beat consensus (−$0.5313 vs −$0.5450). Revenue for continuing operations remained de minimis relative to a small consensus ($0.3125M), consistent with Omeros’ pre‑commercial profile (S&P Global). Actual GAAP EPS from continuing operations was −$0.44, while total GAAP net loss per share was −$0.43 .
• Revisions watch: Management guided Q3 OpEx lower vs Q2, but expects ~+$9.2M interest expense ex non‑cash; discontinued ops income $5–7M. Net loss trajectory could be mixed (lower OpEx vs higher interest), warranting potential fine‑tuning of Q3 loss estimates .

*Values retrieved from S&P Global.

Key Takeaways for Investors

• Regulatory: The 3‑month PDUFA extension to Dec 26, 2025 pushes timing but management reports supportive analyses and collaborative review dynamics—labeling talks expected by October if no major issues .
• De‑risked capital structure: Near‑term debt reduced >$100M; residual 2026 notes only $17.1M; optionality improved via July equity raise and ongoing ATM facility .
• Launch setup: Concentrated customer base (175 U.S. transplant centers) enables focused commercialization; positive payer/physician feedback and sufficient launch supply underpin readiness .
• Earnings cadence: With minimal continuing revenue, quarterly earnings are driven by OpEx and financing/remeasurement items; Q3 guide suggests lower OpEx but higher cash interest, implying a potentially similar magnitude net loss absent additional non‑cash credits .
• OMIDRIA variability: OMIDRIA royalties (discontinued ops) declined YoY and remain subject to Rayner forecast changes and associated non‑cash remeasurements, impacting below‑the‑line items .
• Strategic optionality: A potential multi‑billion transaction (ex‑royalties) could retire remaining term loan and converts and fund >12 months of operations—key near‑/mid‑term catalyst alongside U.S. approval .
• Trading lens: Stock likely to trade on (i) FDA review momentum (e.g., labeling discussions), (ii) partnering news flow, and (iii) capital updates relative to the $25M minimum liquidity covenant .

Appendices

Results vs Estimates (detail)

• Company confirmed no recognized product or royalty revenue in continuing operations; OMIDRIA economics run through discontinued operations and balance‑sheet remeasurements .
• Q2 OMIDRIA royalties earned: $8.6M on $28.6M U.S. net sales (discontinued ops) .

Regulatory/Program Milestones

• FDA BLA resubmission accepted; PDUFA extended to Dec 26, 2025; EMA MAA validated with CHMP opinion expected mid‑2026 .
• PDE7 OMS527 inpatient study targeted early 2026; OncotoX‑AML IND-enabling continues (clinic entry targeted 18–24 months) .

Citations:

• Q2 2025 8‑K/press release (financials and updates): .
• Q1 2025 8‑K/press release: .
• Q2 2025 earnings call transcript: .
• EMA MAA PR: .
• FDA acceptance PR: .

S&P Global estimates: Values marked with an asterisk (*) are from S&P Global (consensus and actual “Primary EPS”).