Geron (GERN) investor relations material

U.S. RYTELO commercial progress

• Quarterly net revenue exceeded $60M, marking a fourth consecutive quarter of growth; growth was driven primarily by community accounts, which serve ~80% of U.S. low-risk MDS patients.

• RYTELO has been ordered by 1,700 accounts, with 100–200 new accounts added per quarter; growth is expected to draw on both account breadth and prescribing depth over coming quarters.

• First- and second-line patients now represent 36% of the patient population, rising 1–2 percentage points per quarter on a 12-month look-back KPI; management estimates ~8,000 U.S. patients could benefit in second line.

• Real-world evidence showed duration on therapy resembling IMerge despite more advanced, sicker post-launch patients; second-line response duration was moving toward the trial’s 7.8–8-month range.

• Commercial focus includes high-volume community accounts, physician education on managing first-cycle cytopenias, and RYTELO use after luspatercept and before HMAs; luspatercept’s first-line expansion may create more second-line opportunity.

European commercialization

• A gated hybrid strategy prioritizes value dossiers and pricing preparation, with work in 2026 addressing the 9–12 months typically needed before payer pricing negotiations; partnerships remain an option.

• A commercial sale in Germany is planned before year-end, with a visible pre-AMNOG negotiated price; Germany was selected as a launch market and pricing reference for other countries.

• Management cited European market potential from earlier intervention, a significant aging population, IMerge physician familiarity, and lower HMA use; Germany’s care model resembles the U.S., while France relies more on hematology centers of excellence.

• Additional European infrastructure was built cost-effectively while OpEx was reduced by $10M this year; some SG&A increase may occur next year, with spending discipline maintained through offsets.

Pipeline, financial priorities and business development

• Following discontinuation of the phase III IMpactMF trial, priorities are growing the RYTELO base business, expanding RYTELO ex-U.S., continuing investigator-sponsored trial discussions, and pursuing business development.

• Management cited expected FY revenue of $230M–$240M and growth potential over multiple years; it said operations can be funded without needing cash in the foreseeable future.

• The business reached profitability in the prior quarter; management said near-term focus remains company-building and growth, while lean operating costs support a short-term path to profitability and BD supports longer-term health.

• The recently hired CBO is building diligence capabilities; preferred opportunities are later-stage or commercial hematology or oncology assets that could fit the existing community-based sales team.