Q3 2026 Geron Earnings Conference Call - GERON CORP

Explicit Guidance:

• Full-Year 2026 Net Revenue: Reiterated expectation to finish at the mid-to-high end of the $220 million to $240 million range, driven by consistent quarter-over-quarter demand growth.
• Full-Year 2026 Operating Expenses (OPEX): Lowered guidance from $230 million–$240 million to a revised range of $220 million to $230 million, reflecting workforce reductions and operational efficiency.
• 2026 Gross-to-Net Deductions: Expected to remain in the low-to-mid 20s (Q3 was 19.3% vs. 21.6% in Q3 2025).
• 2027 & Beyond OPEX: Management expects OPEX to remain steady for the remainder of 2026 but anticipates increases in 2027 due to the maturation of the Europe commercial strategy and post-marketing clinical trial commitments.

Business-Segment Outlook:

• Rytello (U.S.): Projected to deliver consistent quarter-over-quarter demand growth for years to come. Current trajectory shows a 10% sequential demand increase, expanding prescribing accounts to over 1,700 (36% of starts are first/second-line). Focus remains on community oncology adoption where thousands of low-risk MDS patients remain untreated.
• Rytello (International/Europe): Initiated a gated commercial launch starting with Germany by the end of 2026, with France scheduled for 2027. The strategy utilizes a hybrid model to retain pricing control and preserve optionality for future partnerships without immediate large infrastructure investment.
• Pipeline & Product: Discontinued the Phase III IMPACT-MS trial (imetelstat + JAK inhibitor) for relapsed/refractory myelofibrosis; no new safety signals observed, but trial deemed unlikely to meet overall survival primary endpoint. Management to analyze and share unblinded data at future medical meetings.
• Business Development (M&A): Targeting hematology or oncology assets suitable for the community setting (peak sales in the few million range rather than multi-billion blockbuster assets). Strategy focuses on a "string of pearls" approach to complement the existing Rytello commercial team.

Market and Competitive Outlook:

• Competitive Landscape (Europe): Anticipated advantage due to less entrenched use of HMA therapies in second/third-line settings compared to the U.S., an older patient demographic, and a less diversified treatment option landscape.
• Differentiation: Rytello's single-indication status and orphan designation (vs. competitors with multiple indications) are expected to facilitate higher reimbursement scoring, particularly in Germany.
• Demand Trends: Continued strength in low-risk MDS treatment with "durable clinical outcomes" and evidence of disease-modifying activity reinforcing long-term market acceptance.

Macro / Industry Outlook:

• Regulatory Environment: Highlighted the exclusion of orphan drugs like Rytello from the CMS GLOBE model as a catalyst to serve more patients globally while maintaining U.S. price integrity.
• FX/Translation: No specific FX rate guidance provided, but management notes the strategy is designed to retain pricing flexibility in international markets.
• Market Access: Anticipated favorable reception in Europe driven by significant unmet needs in RS-negative patient populations and prior trial success in the region (iMERGE).

Strategic Initiatives:

• Commercial Expansion: Executing a "go-to-market" strategy for ex-U.S. regions using a gated, staged approach to minimize upfront capital while maintaining partnership flexibility.
• Financial Discipline: Continued focus on operational efficiency via targeted investments; recent workforce reduction (Dec 2025) drove a 9% year-to-date OPEX reduction.
• R&D Focus: Maintaining investment in CMC and post-marketing commitments while offsetting employee costs; MF program spending expected to not decrease significantly in 2026 due to wind-down activities.
• Asset Deployment: Intent to deploy excess cash ($339M on hand) toward business development to add pipeline assets to the commercial team.

Risks and Headwinds to Outlook:

• Trial Discontinuation: The decision to stop the IMPACT-MS trial removes a potential upside growth driver for the myelofibrosis franchise, though management frames this as a necessary resource reallocation.
• Adoption Risks: Growth depends on continued execution of personal/non-personal engagement strategies to convert the "thousands" of treatable patients in the community setting.
• International Execution: The European rollout is contingent on successful regulatory engagement and reimbursement processes in Germany (target: year-end) and France (2027).
• Guidance Uncertainty: Standard forward-looking statement warnings regarding material differences from actual results due to risks and uncertainties outlined in the Form 10-Q and periodic reports.

Management Tone on the Future:

• Confidence: High confidence in Rytello's "long growth runway" and the "winning strategy" of consistent quarter-over-quarter growth.
• Sentiment: Optimistic regarding the balance sheet strength ($339M cash) and the ability to pursue strategic BD opportunities now that the MF "overhang" is behind the company.
• Strategic Pivot: Expresses a shift from pure R&D speculation to "building a leading hematology company" through commercial execution and selective, value-accretive M&A.

Miscellaneous:

• Cash Position: Reported $339 million in cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2026.
• Scientific Momentum: Six accepted abstracts for the 68th ASH annual meeting in December 2026; recognized with a nomination for the Pre-Dallium USA Award for Best Product for Orphan-Aware Diseases.
• Operational Efficiency: Gross-to-net deductions improved to 19.3% (Q3 2026) from 21.6% (Q3 2025); R&D expenses decreased 40% year-over-year to $12.7 million due to workforce reductions.