Q3 2026 Geron Earnings Conference Call - GERON CORP

Explicit Guidance:

• FY2026 Net Revenue: Reiterated range of $220 million to $240 million; management expects results to land at the mid-to-high end of this range driven by consistent QoQ demand growth.
• FY2026 Operating Expenses: Guidance lowered from $230 million to $240 million to a new range of $220 million to $230 million.
• FY2027 and Beyond OPEX: Management anticipates OPEX increases in next year (2027) to fund the maturation of the Europe commercial strategy and post-marketing clinical trial commitments.
• Gross-to-Net Deductions: Expected to remain in the low-to-mid 20s for the remainder of FY2026.
• Cash Position: $339 million in cash, equivalents, restricted cash, and marketable securities as of Sept 30, 2026, providing capital for operations and Business Development (BD).

Business-Segment Outlook:

• Rytello (Ritello) U.S.: Projected to deliver consistent quarter-over-quarter demand growth for years to come; currently at 10% QoQ demand growth (Q3) with an 8% increase in prescribing accounts. Footprint expanded to >1,700 accounts; first-and-second-line patient starts comprise 36% of rolling 12-month starts.
• Rytello Europe: Executing a "gated commercial launch" strategy to scale availability via partnerships while retaining pricing control. Germany: Commercial availability expected by end of 2026. France: Launch planned for 2027.
• Pipeline/Inflection Points: Discontinuation of IMPACT-MS Phase III trial (myelofibrosis) effective immediately; no further significant spending on MF program in 2026 due to wind-down activities.
• Community Adoption: Focus on accelerating uptake in community settings where thousands of patients remain unaddressed.

Market and Competitive Outlook:

• Competitive Landscape: Differentiated by orphan drug designation and single indication, contrasting with competitors like Novartis/Robazol (who face multiple price iterations due to broader labels/indications).
• Pricing Environment: CMS GLOBE model exclusion for orphan drugs creates opportunity to serve more patients globally while maintaining price integrity.
• Treatment Patterns: Anticipated lower reliance on HMAs (Hypomethylating Agents) in second/third-line settings in Europe compared to the U.S., favoring Rytello's position.
• Patient Population: Eligible second-line low-risk MDS population estimated at ~8,000 in the U.S.; European market noted to have an older patient demographic with significant unmet need, particularly in RS-negative populations where competitors face restrictions.

Macro / Industry Outlook:

• Regulatory: Success in European regulatory engagement and reimbursement processes anticipated to broaden access without large upfront infrastructure investments.
• Economic/Operational: Management views current fiscal discipline as enabling flexible capital allocation for strategic growth.

Strategic Initiatives:

• Business Development (BD): Active pursuit of hematology/oncology assets suitable for the community-based commercial team. Criteria include single-digit peak sales potential (not $2B–$3B assets) to enable a "string of pearls" growth strategy over the next several years.
• European Expansion: Launching a hybrid model in targeted European markets to preserve flexibility for future partnership opportunities.
• Scientific Engagement: Continued focus on ASH Annual Meeting (December 2026) with six accepted abstracts to reinforce clinical evidence for low-risk MDS and other hematologic diseases.
• Data Utilization: Commitment to analyze and share the rich dataset from the discontinued IMPACT-MS trial to inform future myelofibrosis research directions.

Risks and Headwinds to Outlook:

• Clinical Uncertainty: The discontinuation of the IMPACT-MS trial highlights the risk that trials may not meet primary endpoints (overall survival), though no new safety signals were observed.
• Market Execution: Success of the European launch is contingent on regulatory and reimbursement timelines in Germany (2026) and France (2027).
• Growth Rate Variability: While confident in QoQ growth, management notes the exact inflection point is dependent on executing the strategy correctly in the community setting.
• OPEX Trajectory: While 2026 costs are reduced, future OPEX increases are expected due to Europe maturation and post-marketing commitments.

Management Tone on the Future:

• Confidence Level: High confidence in Rytello's long-term growth runway and revenue guidance, citing four consecutive quarters of demand growth.
• Strategic Shift: Tone indicates a transition from pure R&D burn to a commercial execution phase with disciplined capital allocation and a strategic pivot toward accretive business development now that the MF overhang is cleared.
• Forward-Looking Statements: Management explicitly stated that actual results may differ due to risks and uncertainties described in Form 10-Q and periodic reports; they undertake no duty to update forward-looking statements.

Miscellaneous:

• Award Recognition: Geron nominated for the Pre-Dallium USA Award for Best Product for Orphan-Aware Diseases.
• Workforce: OPEX reductions reflect lower headcount costs from the December 2025 workforce reduction.