Sign in

You're signed outSign in or to get full access.

GC

GERON CORP (GERN)·Q3 2025 Earnings Summary

Executive Summary

  • Revenue and EPS mixed: Q3 revenue was $47.2M, down 3.7% q/q from $49.0M and up 66% y/y from $28.2M; revenue missed S&P Global consensus of $53.34M. EPS was -$0.03 vs. -$0.034 est., a slight beat . Revenue est marked with * retrieved from S&P Global.
  • Demand softness and mix: RYTELO demand fell 3% q/q as later-line patient discontinuations offset higher first/second-line starts (36% vs. 30% in Q2). Prescribing accounts grew 15% q/q (+~150 to ~1,150), with ~80% of accounts reordering .
  • Cost discipline: FY25 total OpEx guidance cut to $250–$260M from $270–$285M on CMC and infrastructure timing; distributor inventories ended Q3 at high end of 2–4 weeks; gross-to-net increased on Medicaid mix, GPO fees, and returns .
  • Outlook and catalysts: Management frames GERON as a 2026 growth story, focusing on awareness, earlier-line use, community penetration, and medical engagement; ASH 2025 data and completed enrollment of IMpactMF (OS interim 2H26) are near/mid-term catalysts .

What Went Well and What Went Wrong

  • What Went Well

    • Commercial breadth improved: prescribing accounts +15% q/q (+~150) to ~1,150; ~80% of accounts reordered, indicating retention of prescribers even as depth lags .
    • Strategic execution drivers: CEO outlined a focused plan—“substantially increase awareness,” scale KOL/advocacy engagement, expand ISTs, and deepen community penetration to drive earlier-line adoption .
    • Strengthened runway and OpEx control: FY25 OpEx guidance cut to $250–$260M; cash and marketable securities ~$421.5M at quarter-end support operations while preparing for EU commercialization in 2026 .
  • What Went Wrong

    • Demand softness: demand down 3% q/q; higher first/second-line starts (36%) did not offset later-line discontinuations, limiting depth and therapy duration .
    • Gross-to-net and channel dynamics: gross-to-net increased on higher Medicaid mix, GPO fees, and product returns; distributor inventory at high end of 2–4 weeks, reflecting channel adjustments .
    • Timing of growth: management reset expectations—“2026 growth story”—which implies near-term top-line risk as awareness and earlier-line positioning take time to pull through .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$28.3 $39.6 $49.0 $47.2
Net Loss ($USD Millions)$(26.4) $(19.8) $(16.4) $(18.4)
Diluted EPS ($)$(0.04) $(0.03) $(0.02) $(0.03)
Cost of Goods Sold ($USD Millions)$0.46 $1.21 $1.19 $1.04
Gross Margin %98.4% (calc from )97.0% (calc from )97.6% (calc from )97.8% (calc from )
Total Operating Expenses ($USD Millions)$56.5 $56.3 $61.5 $61.1

Q3 2025 vs. S&P Global Consensus

  • Revenue: Reported $47.2M vs. $53.34M consensus → MISS (approx. -11.5%)* .
  • EPS: Reported -$0.03 vs. -$0.034 consensus → BEAT (approx. +0.004 per share)* .
    Consensus values marked with * retrieved from S&P Global.

KPIs and Commercial Metrics

KPIQ2 2025Q3 2025
RYTELO demand q/q+17% -3%
Ordering accounts (approx.)>1,000; +~400 YTD ~1,150; +~150 q/q
New patient starts in 1L/2L30% 36%
Account reordersn/a~80% of accounts reordered in the quarter
Distributor inventoryn/aHigh end of 2–4 weeks
Gross-to-netn/aMid-to-high teens (mix/fees/returns drove increase q/q)

Notes: Company reports one commercial product (RYTELO); no segment reporting .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Operating ExpensesFY 2025$270M–$285M $250M–$260M Raised/Lowered: Lowered
EU Launch Timing (RYTELO)20262026 2026 Maintained
IMpactMF Interim (OS)2H 20262H 2026 2H 2026 Maintained
IMpactMF Final (OS)2H 20282H 2028 2H 2028 Maintained
Top-line (Revenue) GuidanceFY 2025/2026None provided None; “2026 growth story” commentary Maintained (narrative reset)
Liquidity runwayOngoingSufficient with U.S. sales of RYTELO Sufficient for foreseeable future Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Commercial awareness & prescriber breadthBuilt sales force (+20%) and doubled MSLs; >1,000 accounts; focus on awareness and adoption +15% q/q accounts to ~1,150; plan to intensify KOL/advocacy, community penetration, ISTs Improving breadth; depth still lagging
Demand trajectoryQ1 demand flat; Q2 demand +17% q/q Demand -3% q/q; later-line discontinuations offsetting starts Mixed/near-term soft
Earlier-line positioningBuilding education to move earlier-line use 1L/2L starts 36% vs. 30% (Q2); NCCN update supportive Gradual progress
Medical engagement & dataASCO/EHA presence; emphasis on education Five ASH 2025 abstracts (1 oral); cytopenia-response analyses; long-term outcomes trend Increasing momentum
R&D execution (IMpactMF)>95% enrolled; interim 2H26 Fully enrolled (320); interim 2H26; final 2H28 On plan
EU commercializationPlanning 2026 launch Named-patient shipment in Germany; still targeting 2026 in select EU markets Incremental progress
Cost disciplineFY25 OpEx $270–$285M FY25 OpEx lowered to $250–$260M Positive

Management Commentary

  • “Net product revenue was $47.2 million for the third quarter... demand for Rytelo was down 3% compared to last quarter… New patient starts in first and second line increased to 36% compared to 30% in Q2… Prescribing accounts increased by 15%... to 1,150” .
  • “We need to substantially increase awareness for Rytelo… expand reach into community sites… improve conversions and retention… The pull-through of improved execution to revenue growth will take time” .
  • “Five ASH abstracts… oral presentation offers insight into how early cytopenias… may be associated with treatment response… 42-month landmark analysis suggest[s] a favorable trend for imetelstat in overall survival…” .
  • “As of September 30, 2025, we had approximately $420 million in cash… For fiscal year 2025, we expect our total operating expenses to be between $250 million and $260 million” .
  • “We’re saying at this point, this is a 2026 growth story… we are not giving any guidance at this point on our top line” .

Q&A Highlights

  • Gross-to-net: CFO reaffirmed mid-to-high teens; increase driven by higher Medicaid mix, GPO fees, and returns; expected to moderate .
  • Demand dynamics: CEO emphasized later-line discontinuations as key headwind; focus is on earlier-line starts and comprehensive “surround sound” education .
  • Prescriber breadth vs. depth: ~150 new accounts in Q3; ~80% reorders, but depth constrained; push to ensure “right start” in community settings .
  • Duration of therapy: Real-world duration shorter than IMerge given later-line mix; targeting earlier-line use to align with pivotal data .
  • OpEx cadence: FY26 guide not provided; FY25 OpEx reduced via CMC and slower IT/infrastructure ramp .
  • EU partnering: Dialogues ongoing; emphasis on being stewards of capital while focusing internal efforts on U.S. near term .

Estimates Context

Consensus vs. Actuals (S&P Global)

MetricQ1 2025Q2 2025Q3 2025
Revenue Consensus Mean ($)48,540,860*47,303,380*53,340,380*
Revenue Actual ($)39,603,000 49,036,000 47,227,000
Primary EPS Consensus Mean ($)-0.0386*-0.0289*-0.0343*
Primary EPS Actual ($)-0.03 -0.02 -0.03

Notes: Consensus estimates marked with * retrieved from S&P Global.

Implications:

  • Q3 revenue missed consensus materially; EPS modestly beat. Near-term estimate revisions likely trend lower on demand softness and channel adjustments, partially offset by OpEx discipline .

Key Takeaways for Investors

  • Q3 print: Top-line miss vs. consensus on softer demand and later-line discontinuations; EPS slightly better than feared on cost control .
  • Commercial trajectory: Breadth is improving (accounts +15% q/q), but earlier-line conversion and depth remain the swing factors into 2026 .
  • Execution plan: Intensified HCP education, community penetration, and KOL/advocacy engagement should progressively shift use earlier-line—key to improving persistence and revenue quality .
  • Cost discipline: FY25 OpEx cut to $250–$260M provides downside protection as the commercial engine is recalibrated .
  • Clinical and data catalysts: ASH 2025 presentations (including oral) and completed IMpactMF enrollment with OS interim in 2H26 support medium-term optionality .
  • EU optionality: Named-patient shipment to Germany and 2026 selective EU launch plan expand geographic runway without near-term P&L dependence .
  • Trading setup: Near term, visibility remains limited; watch for leading indicators—1L/2L mix, community depth, reorder intensity, and gross-to-net normalization—while 2026 growth narrative and MF readouts anchor the medium-term thesis .

Footnote: Consensus estimates (marked with *) were retrieved from S&P Global.