HomeFinanceGeron (GERN) Q4 2025 Earnings Call Transcript

Geron (GERN) Q4 2025 Earnings Call Transcript

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DATE

Wednesday, February 25, 2026 at 8 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Harout Semerjian
  • Chief Commercial Officer — Ahmed ElNawawi
  • Executive Vice President, Research and Development and Chief Medical Officer — Joseph Eid
  • Chief Financial Officer — Michelle Robertson

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TAKEAWAYS

  • Rytelo Net Revenue — $48,000,000 in Q4 and $184,000,000 for the full year, representing a full year of commercial availability.
  • Total Operating Expenses — $255,000,000 for the year, matching prior guidance of $250,000,000 to $260,000,000.
  • Q4 Rytelo Demand Growth — 9% compared to Q3, with a 13% increase in prescribing accounts in the quarter.
  • Prescribing Account Expansion — Approximately 1,300 accounts by the end of Q4, with 150 new accounts added in the period.
  • First- and Second-Line Patient Mix — About 30% of Rytelo patient starts in the twelve months are first- or second-line therapy.
  • Rytelo Second-Line Opportunity — Estimated 8,000 eligible second-line lower-risk MDS patients in the U.S. targeted for expansion efforts.
  • Gross-to-Net Deductions — 17.7% for 2025, up from 14.5% in 2024, attributed to broader 340B utilization and expanded GPO contracting.
  • 2026 Rytelo Revenue Guidance — Projected net revenue of $220,000,000 to $240,000,000, assuming sequential demand growth throughout the year.
  • 2026 Operating Expense Guidance — Total operating expenses expected between $230,000,000 and $240,000,000, about $20,000,000 lower at the midpoint year over year.
  • Research & Development Expenses — $74,000,000 in 2025 versus $104,000,000 in 2024, citing reduced clinical trial and manufacturing costs post-Rytelo approval.
  • Selling, General and Administrative Expenses — $159,000,000 in 2025, up from $146,000,000 in 2024, mainly due to increased commercial investments.
  • Cash Position — $400,000,000 as of year-end 2025, with access to an additional $125,000,000 via Pharmakon loan extended through July 30, 2026.
  • Strategic Restructuring — Organization-wide restructuring completed in December 2025, with related costs fully recognized in Q4.
  • Real-World Evidence and IST Initiatives — Over 10 ISTs and real-world studies aligned for execution in 2026 to expand Rytelo data in early-line and combination settings.
  • IMPACT MF Trial Update — Interim analysis death event trigger projected for the second half of 2026, with overall survival as the primary endpoint.

SUMMARY

Geron Corporation (GERN +10.17%) detailed full-year 2025 Rytelo net revenue of $184,000,000 and forecasted 2026 Rytelo revenue of $220,000,000 to $240,000,000, underpinned by sequential demand growth and a commercial strategy targeting the estimated 8,000 second-line lower-risk MDS patients in the U.S. Management reported that approximately 30% of patients initiating Rytelo are in first- or second-line therapy, while account breadth increased to approximately 1,300 prescribers by year-end. Gross-to-net deductions rose to 17.7%, with expectations for further increase into the high teens to low 20s in 2026 as broader access channels are leveraged. The company emphasized disciplined expense management, lowering operating expense guidance for 2026 and highlighting a $400,000,000 year-end cash position plus further credit availability. Investments in ISTs and real-world evidence generation are intended to support future medical differentiation, while the fully enrolled IMPACT MF trial is on track for an interim analysis event in the second half of the year.

  • Rytelo was noted as a preferred second-line agent in NCCN guidelines post-luspatercept, enhancing its competitive positioning in the treatment sequence.
  • Michelle Robertson stated, “We definitely see a path to profitability, but that is not our focus in 2026,” clarifying that while margin improvements are planned, reinvestment will take priority over near-term breakeven.
  • Commercial strategy is centered on “targeted engagement with high-volume community accounts,” broadening reach both in academic and community practices.
  • Management indicated European launch plans would depend on navigating HTA processes and securing “the premium we believe Rytelo deserves,” with partnerships or direct commercialization both under consideration.
  • Expansion of medical meetings and peer-to-peer engagement aims to drive both Rytelo awareness and prescriber depth into 2026.

INDUSTRY GLOSSARY

  • Rytelo: Geron Corporation’s telomerase inhibitor for transfusion-dependent anemia in lower-risk myelodysplastic syndromes.
  • IMPACT MF trial: A Phase 3 clinical study assessing imetelstat in relapsed/refractory myelofibrosis, with overall survival as the primary endpoint.
  • IST (Investigator-Sponsored Trial): Clinical trials initiated and managed by non-company investigators that contribute to additional evidence generation for the drug.
  • Gross-to-net deductions: Adjustments from gross product sales for discounts, rebates, and contractual allowances, yielding net revenue.
  • 340B utilization: Drug sales through U.S. public health clinics and covered entities under the federal 340B Drug Pricing Program.
  • GPO (Group Purchasing Organization) contracting: Agreements with organized groups that negotiate drug purchasing terms on behalf of provider members.
  • NCCN guidelines: Clinical practice recommendations from the National Comprehensive Cancer Network guiding cancer treatment decisions.
  • HTA (Health Technology Assessment): Evaluation processes in ex-U.S. markets to determine reimbursement and pricing for new therapies.
  • MFN (Most-Favored-Nation) pricing: A pricing approach in which a country benchmarks drug prices against those paid in peer countries, impacting reimbursement negotiations.
  • RS status: Refers to the presence (ring sideroblast–positive or –negative) of abnormal erythroid precursor cells in myelodysplastic syndromes, influencing drug response and treatment strategy.
  • ASH (American Society of Hematology): Leading international medical society for hematology, hosting annual congresses important for new data dissemination.

Full Conference Call Transcript

Dawn Schottlandt: Please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections including those relating to our 2026 financial guidance, the expected benefits and other impacts of our strategic restructuring plan, our current Rytelo commercialization strategy and related opportunities, the therapeutic potential of Rytelo, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources, our ability to access additional debt financing, and other statements that are not historical fact which, of course, include risks and uncertainties that cause actual events, performance, and results to differ materially from those contained in these forward-looking statements.

Therefore, I refer you to the risks and uncertainties described in today’s earnings release, under the heading Risk Factors in Geron Corporation’s most recent periodic report filed with the SEC which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements, and future updates to Geron Corporation’s risks and uncertainties including in its upcoming annual report on Form 10-Ks. Geron Corporation undertakes no duty or obligation to update its forward-looking statements.

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