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OMEROS CORP (OMER)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was dominated by regulatory and balance sheet milestones: FDA accepted the resubmitted BLA for narsoplimab (Class 2) with a PDUFA target date of September 25, 2025, and OMER executed a convertible note exchange pushing maturities to 2029 and cutting near‑term obligations by >$100M .
  • GAAP results: net loss of $33.5M (vs. $37.2M YoY) and Primary EPS (continuing ops) of -$0.65; cash and short‑term investments were $52.4M at March 31 (down from $90.1M at 12/31/24) .
  • Consensus check: Q1 Primary EPS missed S&P Global consensus (-$0.65 actual vs. -$0.603 estimate); revenue from continuing operations was not reported (consensus ~$0.40M) .
  • Operating focus tightened: OMER paused the Phase 3 PNH program for zaltenibart to conserve cash, suspended the narsoplimab expanded access program, and signaled lower Q2 operating expenses while prioritizing launch readiness and ongoing trials .
  • Potential stock catalysts: (1) PDUFA decision in late September for narsoplimab, (2) EU MAA submission targeted for Q2, (3) financing/partnership updates to fund launch and pipeline .

What Went Well and What Went Wrong

What Went Well

  • FDA accepted narsoplimab BLA resubmission; PDUFA set for late September 2025, with OMER reporting robust survival statistics supporting clinical benefit (primary HR 0.32; p<0.00001) .
  • Balance sheet derisking: $70.8M 2026 converts exchanged into 9.5% 2029 converts; another $10M to convert into equity, reducing 2026 notes to ~$17.1M and lowering near‑term repayment obligations by >$100M .
  • Management conviction and preparedness for launch: “Our highest priority as an organization is to obtain approval for narsoplimab,” and the commercial team has targeted top 40–80 transplant centers for a “fast start,” with payer dialogues underway .

What Went Wrong

  • Liquidity declined: cash and short‑term investments fell to $52.4M at quarter‑end from $90.1M at 12/31/24, reflecting spend and no current product revenues recognized in continuing operations .
  • OMIDRIA royalty trend softened sequentially: $6.7M royalties on $22.3M Rayner U.S. sales vs. Q4 2024 royalties of $10.1M on $33.6M U.S. sales; royalties through 2031 are remitted to DRI (non‑P&L revenue) .
  • Pipeline pacing: Phase 3 PNH program for zaltenibart paused to conserve capital; expanded access program for narsoplimab suspended to reduce costs, potentially slowing patient exposure and external validation flow pre‑approval .

Financial Results

P&L and EPS vs prior periods (continuing operations; oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Revenues ($M)$0.0 (no revenues reported) $0.0 (no revenues reported) $0.0 (no revenues reported)
Total Operating Expenses ($M)$35.41 $35.66 $34.97
Loss from Operations ($M)$(35.41) $(35.66) $(34.97)
Interest Expense ($M)$4.05 $3.18 $3.65
Interest & Other Income ($M)$2.35 $2.30 $1.06
Net Loss from Continuing Ops ($M)$(37.11) $(36.54) $(37.57)
Primary EPS (Continuing Ops)$(0.64) $(0.63) $(0.65)

Notes: Omeros did not report product revenues from continuing operations; OMIDRIA royalties are treated below the line in discontinued operations .

Discontinued operations, royalties, and liquidity (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
OMIDRIA U.S. Net Sales by Rayner ($M)$31.0 $33.6 $22.3
OMIDRIA Royalties Earned ($M)$9.3 $10.1 $6.7
Net Income from Discontinued Ops ($M)$4.88 $5.18 $4.11
Cash & Short‑Term Investments ($M)$123.2 $90.1 $52.4

Q1 2025 vs S&P Global consensus (EPS & revenue)

MetricConsensusActual
Primary EPS (Continuing Ops)-0.6033*-0.65
Revenue (Continuing Ops, $M)0.40*0.00 (no revenues reported)

Values with asterisks (*) retrieved from S&P Global.

Segment breakdown: Not applicable; no reported segment revenues in continuing operations .

KPIs (selected Q1 2025)

  • Total Operating Expenses: $35.0M
  • Interest Expense: $3.7M
  • Cash and Short‑Term Investments: $52.4M
  • Convertible Notes Exchange: $70.8M swapped into 9.5% 2029 converts; $10.0M to be converted to equity; 2026 notes reduced to ~$17.1M .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Expenses (cont. ops)Q2 2025N/A“Lower vs Q1 2025” Lowered
Interest & Other Income ($M)Q1 2025~1.1 (from Q4 call) ——
Interest & Other Income ($M)Q2 2025—~0.625 Lower sequentially
Interest Expense ($M)Q1 2025~7.2 incl. non‑cash (from Q4 call) ——
Interest Expense ($M)Q2 2025—~7.6 excl. non‑cash Higher vs Q1 run‑rate excl. non‑cash
Income from Discontinued Ops ($M)Q1 2025$7–$8 (from Q4 call) ——
Income from Discontinued Ops ($M)Q2 2025—$6–$7 Lowered

Management also reiterated plans to pursue partnerships, ATM equity capacity ($150M), and other financing options to fund operations and launch .

Earnings Call Themes & Trends

TopicQ3 2024 (Q-2)Q4 2024 (Q-1)Q1 2025 (Current)Trend
Narsoplimab regulatory pathPre‑submission SAP alignment with FDA; plan to resubmit BLA BLA resubmitted; robust survival stats (HR 0.32; e‑value 5.7); EU MAA prep; ICD‑10/CPT groundwork FDA accepted resubmission; Class 2; late Sept PDUFA; EU MAA targeted Q2 Strengthening; clear catalyst
Launch readinessBuilding KOL/center relationships; groundwork Team “well‑prepared”; 174 centers; 40 do 60% of transplants; payer/reimbursement path “Fast start” accounts (top 40–80 centers); active payer info exchanges Increasing preparedness
Balance sheet/liquidityCash $123.2M; options (term loan DD facility conditional) Restructure converts; explore partnerships/royalty monetization/ATM Executed convert exchange; reduced near‑term debt; still raising additional capital Near‑term maturities addressed; funding still needed
Zaltenibart (PNH/C3G)Phase 3 designs agreed with FDA/EMA; head‑to‑head vs C5 Phase 3 manufacturing ready; dosing profile; no safety signal Phase 3 PNH paused to prioritize capital; ongoing PNH naive and extension; C3G Phase 2 continues Execution paced by capital
EAP and clinical evidenceManuscripts in prep Tandem meeting EAP outcomes positive EAP analyses confirm survival benefit; HR 0.34–0.46; p<0.00002 Reinforcing efficacy narrative
Cost actions—Q1 OpEx comparable to Q4 Program pauses; Q2 OpEx to decline vs Q1 Tighter spend

Management Commentary

  • “We are pleased that our BLA for narsoplimab in TA‑TMA has been accepted by FDA… our highest priority as an organization is to obtain approval for narsoplimab.” — Gregory A. Demopulos, M.D., CEO .
  • “Overall… reduce our near‑term debt maturities… from approximately $118 million to approximately $17 million.” — Demopulos on the convert exchange .
  • Commercial: “We have… cultivated what we’re calling fast start accounts… top 40 centers that are responsible for ~60% of the allogeneic transplant volume… engaging with payers” — Nadia Dac, CCO .
  • Clinical/statistical: “Primary analysis shows a more than threefold improvement in survival… p‑value of less than 0.00001… e‑value 5.7” — Demopulos .

Q&A Highlights

  • Launch readiness and patient pathway: OMER emphasized focus on centers that actively monitor TA‑TMA and the potential to treat inpatient and outpatient; payer discussions underway given anticipated first‑in‑class status .
  • Patient severity/cost context: Management underscored rapid progression, high ICU/inpatient costs, and potential economic value from improved survival and outpatient dosing .
  • Pricing: Not disclosed; directional view “similar to other complement inhibitors used in TA‑TMA,” considering inpatient/outpatient mix and unique value as first approved therapy .
  • Zaltenibart safety: No liver safety signal observed; trial design excludes significant pre‑existing liver disease to avoid confounding .
  • Financing strategy: Multiple levers (partnerships, royalty monetization, debt/equity/ATM) with convert restructuring as a key step to enable capital raising for launch .

Estimates Context

  • Q1 2025 Primary EPS (continuing ops): actual -0.65 vs S&P Global consensus -0.6033*, a miss of ~$0.05. Revenue (continuing ops) was not reported vs consensus ~$0.40M* .
  • Q2 2025 consensus context: Primary EPS -0.545*; revenue ~$0.31M* (company guided lower interest income and higher interest expense ex non‑cash) .

Values with asterisks (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Binary regulatory catalyst in late September: robust and consistent survival data (primary HR 0.32) underpin the narsoplimab BLA; an approval would unlock launch and accelerate financing options .
  • Liquidity remains the swing factor: cash fell to $52.4M; convert exchange reduced near‑term maturities, but additional capital is needed to bridge to approval/launch; monitor partnership/ATM updates .
  • Commercial setup is targeted: relationships with top transplant centers and payer engagements should enable a focused launch if approved; ICD‑10/CPT groundwork may facilitate reimbursement and limit off‑label alternatives .
  • OMIDRIA royalties provide cash support but are remitted to DRI through 2031; trend softened in Q1; watch Rayner volume trajectory and any ex‑U.S. contributions longer term .
  • Pipeline pacing reflects capital discipline: Phase 3 PNH paused; ongoing naive/extension studies and C3G Phase 2 continue; efficacy profile and dosing convenience remain differentiators for zaltenibart .
  • Near‑term prints: Q2 OpEx to decline vs Q1; interest expense ~ $7.6M ex non‑cash and lower interest income imply continued losses absent revenue; estimate revisions may bias modestly negative near term .
  • Trading setup: stock likely to be catalyst‑driven into PDUFA; financing headlines (uses/pricing/partners) are potential volatility events ahead of September .

Additional Primary Source Highlights (Q1 2025 period)

  • EAP analyses: Combined pivotal+EAP high‑risk adult allogeneic patients showed HR 0.34–0.46 with p<0.00002; previously refractory patients achieved markedly higher 1‑yr survival than historic <20% benchmarks .
  • Program reprioritization: temporary suspension of EAP (cost savings); limited OMS1029 spend; reduced/halted other complement programs to focus on launch and ongoing patient trials .