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OMEROS CORP (OMER)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 GAAP EPS was -$0.54, a beat versus Wall Street consensus of -$0.71; OMIDRIA royalties rose sequentially to $10.1M on Rayner U.S. net sales of $33.6M. Bold beat driven by lower interest expense and stable OpEx . EPS consensus from S&P Global: -$0.71 (3 estimates)*.
  • BLA for narsoplimab in TA‑TMA was resubmitted; company expects a six‑month FDA review cycle targeting a September 2025 PDUFA date, with EMA MAA submission planned in 1H25 .
  • Year‑end liquidity: $90.1M cash and short‑term investments; 2024 outlays totaled $42.7M (convertible notes repurchase $21.7M, narsoplimab drug substance $19.1M, senior debt transaction $1.9M) .
  • Call commentary emphasized robust survival analyses for narsoplimab (hazard ratio 0.32; p<0.00001) and initiation of Phase 3 programs for zaltenibart in PNH; management is preparing for U.S. launch and pursuing ex‑U.S. partnerships .
  • Near‑term stock catalysts: FDA acceptance of resubmission and PDUFA clock confirmation, EMA MAA submission, and Phase 3 zaltenibart site activations/head‑to‑head execution; medium‑term: PNH Phase 3 data and potential financing/partnership announcements .

What Went Well and What Went Wrong

What Went Well

  • Narsoplimab survival benefit robust across analyses with hazard ratio 0.32 and p<0.00001; management: “results… are robust, consistent, statistically significant, and highly clinically meaningful” .
  • Sequential improvement in OMIDRIA royalties ($10.1M vs $9.3M in Q3) and lower interest expense ($3.2M vs $4.1M in Q3), supporting EPS beat .
  • Launch readiness: drug supply available for 2–3 years; commercial team relationships across key transplant centers; pricing and reimbursement groundwork (ICD‑10/CPT linkage) underway .

What Went Wrong

  • Cash and short‑term investments fell to $90.1M with $29.0M cash used in operations in Q4; 2024 saw $42.7M in significant outlays, pressuring runway .
  • Shareholder deficit deepened and OMIDRIA royalty obligation increased (non‑current $195.6M vs $116.6M YE23), reflecting balance sheet strain .
  • Revenue remains effectively zero from continuing operations; business reliant on discontinued OMIDRIA royalties and financing until narsoplimab approval and commercialization .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Net Loss ($USD Millions)$56.041 $32.232 $31.358
GAAP EPS ($USD)-$0.97 -$0.56 -$0.54
Total Operating Expenses ($USD Millions)$59.157 $35.407 $35.660
Interest Expense ($USD Millions)$9.215 $4.052 $3.177
Interest and Other Income ($USD Millions)$3.247 $2.346 $2.296
Net Income from Discontinued Ops ($USD Millions)$9.084 $4.881 $5.183
Cash + Short‑Term Investments ($USD Millions)$158.9 $123.2 $90.1
OMIDRIA Royalties ($USD Millions)$10.9 $9.3 $10.1
Rayner U.S. Net Sales ($USD Millions)$36.4 $31.0 $33.6
Reported Revenue ($USD Millions)N/A (no revenue reported) N/A (no revenue reported) N/A (no revenue reported)

Notes: Omeros records OMIDRIA royalties within discontinued operations and as adjustments to the OMIDRIA contract royalty asset, not as revenue .

Estimate Comparison (Q4 2024):

MetricConsensusActual
GAAP EPS ($USD)-$0.71*-$0.54
Revenue ($USD Millions)$0.0*N/A (no revenue reported)
EPS Estimates (#)3*—
Revenue Estimates (#)3*—

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

KPIs

KPIQ2 2024Q3 2024Q4 2024
Cash Used in Operations ($USD Millions)——$29.0
Total Operating Expenses ($USD Millions)$59.157 $35.407 $35.660
Interest Expense ($USD Millions)$9.215 $4.052 $3.177

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Expenses (continuing ops)Q1 2025Similar to Q4 2024 (implied) Comparable to Q4 2024 Maintained
Interest and Other Income ($USD Millions)Q1 2025~$1.2 (Q4 2024) ~$1.1 Lowered
Interest Expense ($USD Millions)Q1 2025$3.2 (Q4 2024 actual) ~$7.2 (incl. non‑cash adjustments) Raised
Income from Discontinued Ops ($USD Millions)Q1 2025$5.2 (Q4 2024 actual) $7–$8 Raised
Narsoplimab FDA Review (PDUFA)2025—Target ~September 2025 New/Confirmed
Narsoplimab EMA MAA1H 2025—Submit in 1H 2025 New/Confirmed
Zaltenibart Phase 3 PNH data availabilityQ4 2025—Anticipated in Q4 next year New/Confirmed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
Regulatory/legal (narsoplimab BLA)Ongoing FDA dialogue; Rare Disease Innovation Hub noted; pre‑submission meeting in Sep with minor SAP feedback BLA resubmitted; 6‑month review clock; robust survival stats (HR 0.32, e‑value 5.7) Positive progress/validation
Launch readiness (manufacturing/commercial)Manufacturing in progress; advisory boards; supply for trials 2–3 years narsoplimab supply; relationships across 174 U.S. transplant centers; ICD‑10/CPT linkage Strengthening execution
Zaltenibart (PNH Phase 3)End‑of‑Phase 2 alignment with FDA/EMA; dose selection; small Phase 3 sizes; manufacturing complete Phase 3 initiated (two studies; head‑to‑head vs C5 inhibitors); market access/pricing work (G‑BA) Advancing to pivotal
C3G & rare pediatric voucherReceived rare pediatric disease designation; plan Phase 3 initiation 1H25 Phase 2 dosing ongoing; protocol expanded; voucher value discussed Continued progress
Balance sheet/financingTerm loan, converts repurchase; cash $158.9M (Q2), $123.2M (Q3) Cash $90.1M; discussions to retire/refinance 2026 notes; potential partnerships/royalty monetization/ATM facility Increased urgency to refinance
OMIDRIA royalties tailwindQ2/Q3 royalties and policy changes (HOPD separate payment starting Jan 1, 2025) Q4 royalties up QoQ; continued asset accounting treatment Sequential improvement

Management Commentary

  • “The results… are robust, consistent, statistically significant, and highly clinically meaningful… primary hazard ratio was 0.32… p‑value well less than 0.00001… e‑value 5.7… possibility of unmeasured confounders is vanishingly small.” – Gregory A. Demopulos, CEO .
  • “We have all the drug supply necessary to launch and to support narsoplimab through… two to three years of utilization.” – Gregory A. Demopulos, CEO .
  • “Pricing is never final… narsoplimab will deliver significant value… potential to be administered both in inpatient and outpatient settings.” – Nadia Dac, CCO .
  • “We are very excited… moving back to being a commercial entity… Omidria brought in net revenues to Omeros north of $1 billion through sales and partnerships and royalty sales.” – Gregory A. Demopulos, CEO .

Q&A Highlights

  • Pricing and reimbursement: Directional pricing to reflect survival benefit; dual inpatient/outpatient administration pathways; final pricing TBD .
  • Safety and Phase 3 design for zaltenibart: No liver toxicity signal observed; exclusion of confounding pre‑existing liver disease; randomized trials in C5‑inadequate responders and complement‑naïve patients, head‑to‑head with C5 inhibitors .
  • Balance sheet strategy: Plans to restructure remaining 2026 converts, add capital via partnerships, royalty monetization, debt/equity (including $150M ATM) .
  • Manufacturing scalability and launch awareness: Sufficient supply for 2–3 years; targeted field team engaging top transplant centers; increased TA‑TMA awareness .
  • Long‑term strategy: U.S. self‑commercialization for narsoplimab; ex‑U.S. partnerships for narsoplimab and zaltenibart; confidence in approval paths .

Estimates Context

  • Q4 2024 GAAP EPS actual -$0.54 vs S&P Global consensus -$0.71 (3 estimates), a beat of $0.17. Note: SPGI “actual” shows -$0.55 for Primary EPS, while company press release reports -$0.54; difference likely rounding/definition of “Primary EPS” vs GAAP .
  • Revenue consensus $0.0*; company reports no revenue from continuing operations, with OMIDRIA royalties accounted within discontinued operations and asset remeasurement mechanics .
  • Implication: Near‑term estimate revisions likely to reflect improved EPS trajectory from lower interest expense and stable OpEx; 2025 estimates hinge on regulatory milestones (FDA acceptance, PDUFA) and launch timing .

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

Key Takeaways for Investors

  • Narsoplimab’s resubmitted BLA and robust survival data materially de‑risk regulatory outcome; a confirmed FDA acceptance and PDUFA clock start would be a near‑term catalyst .
  • Q4 EPS beat reflects lower interest expense and steady OpEx; continue monitoring Q1 2025 interest expense step‑up (~$7.2M guided) and discontinued ops income ($7–$8M) .
  • Liquidity declined to $90.1M; management is actively pursuing refinancing of 2026 converts and external capital—expect financing headlines (ATM, partnerships, royalty monetization) .
  • Commercial readiness is advanced: supply secured, center relationships established, reimbursement coding in place—supports rapid post‑approval ramp .
  • Zaltenibart’s Phase 3 head‑to‑head design versus C5 inhibitors and favorable safety profile position it for differentiated adoption; watch for enrollment progress and 2025 data updates .
  • OMIDRIA royalties remain a cash flow contributor; sequential improvement QoQ and HOPD policy tailwinds noted previously should aid 2025 discontinued ops income .
  • Risk factors: regulatory interpretation of external controls, balance sheet strain, and timing of capital raises; management’s multi‑pronged financing approach mitigates but does not eliminate execution risk .