GERON CORP Q4 FY2024 earnings call

• FDA approved RYTELO in June 2024 for certain lower-risk MDS patients. - RYTELO received favorable placement in MDS NCCN guidelines. - 80% enrollment in pivotal imetelstat Phase 3 IMpactMF trial in myelofibrosis. - Commercial launch of RYTELO with initial revenue but flat revenue trends recently. - Changed commercial and medical affairs leadership a few months into launch. - Plan to refocus sales efforts on driving new patient starts across all lines of therapy and enhance medical affairs education and awareness.

RYTELO, Geron's first-in-class telomerase inhibitor, generated $47.5 million in net product revenue in the fourth quarter of 2024. From the end of June 2024 (when product became available) through year-end, total net product revenue was $76.5 million. RYTELO is the primary product segment contributing to revenue.

• Expect total operating expenses in 2025 to be in the range of approximately $270 million to $285 million. - Expect to reach profitability without additional financing if internal sales and operating expense expectations are met. - EU approval of RYTELO for marketing authorization application expected in the first half of 2025. - Key readouts from myelofibrosis clinical programs, including interim analysis from Phase 3 IMpactMF in the second half of 2026 and primary analysis from Phase 1 IMproveMF in 2026.

• Flat revenue trends observed over the last few months. - Seasonality and market hesitancy around holidays affecting new patient starts. - Need to address commercial and medical affairs leadership changes to drive better performance.

Q: Peter Lawson asked about revenues, flat revenues over the last few months, week-over-week growth, and 2025 revenues and costs.

A: Jim Ziegler said week-over-week revenues had variability, four and eight-week rolling averages underscored flatness, and Michelle Robertson mentioned no guidance on revenues yet but operating expenses expected to be $270M-$285M.

Q: Tara Bancroft inquired about seasonality, patterns in the indication, and expected growth cadence.

A: Jim Ziegler noted seasonality around holidays, high correlation with other products in the space, and expected growth driven by new patient starts across all lines of therapy as share of voice increases.

Q: Faisal Khurshid asked about impact on new patient starts vs discontinuations/dose modifications and inflection in new patient growth.

A: Jim Ziegler said primary drivers are new patient starts and duration of treatment, with softness related to new patient starts, and John Scarlett mentioned steady growth in third line leading to earlier lines with execution and messaging.

Q: Greg Harrison asked about KOL feedback and differences in academic vs community settings.

A: John Scarlett said KOL feedback shows RYTELO works, and there's opportunity to increase share of voice, especially in the community.

Q: Stephen Willey asked about patient mix, data generation for value proposition, and U.S. trajectory vs Europe.

A: Jim Ziegler and Joseph Eid discussed patient mix, data generation in MDS and myelofibrosis, and focus on U.S. with plans for Europe prework.

Q: Emily Bodnar asked about new patient starts source and myelofibrosis enrollment timeline.

A: Jim Ziegler said new patient starts include repeat prescriptions at academic centers and diffusion in community, and Faye Feller noted myelofibrosis enrollment proceeding well with interim/final analysis not dependent on enrollment timing.

Q: Kalpit Patel asked about flattening timeline, patient subgroups, and $1B+ revenue estimate.

A: Jim Ziegler discussed flattening around holidays, market research on patient subgroups, and stood by $1B+ revenue potential with increased awareness.

Q: Gil Blum asked about OpEx guidance and convincing physicians to try RYTELO.

A: Michelle Robertson said OpEx budget accounted for investments, and John Scarlett emphasized increasing education, awareness, and initial clinical experience to drive new patient starts.