Geron Q4 2024 Earnings Report
Key Takeaways
Geron Corporation reported Q4 2024 financial results, achieving $47.5 million in RYTELO net product revenue and ending the year with a strong cash position. The company expects to reach profitability without additional financing if current sales and operating expense expectations are met. Continued progress in development efforts for relapsed/refractory myelofibrosis could potentially double commercial opportunity.
Achieved $47.5 million in RYTELO net product revenue in Q4 2024.
Received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval of RYTELO.
Achieved approximately 80% enrollment in the Phase 3 IMpactMF trial.
Presented new data at the 66th American Society for Hematology (ASH) Annual Meeting.
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Geron Revenue by Segment
Forward Guidance
For fiscal year 2025, Geron expects total operating expenses to be in the range of approximately $270 million to $285 million and expects to reach profitability without additional financing if current internal sales and operating expense expectations are met.
Positive Outlook
- Expects to reach profitability without additional financing if current internal sales and operating expense expectations are met.
- Existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.
- Continued execution on U.S. commercial launch of RYTELO.
- Received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval of RYTELO.
- Phase 3 IMpactMF trial evaluating imetelstat in patients with relapsed/refractory myelofibrosis (R/R MF) is ongoing.
Challenges Ahead
- Total operating expenses for fiscal year 2025 are expected to be in the range of approximately $270 million to $285 million.
- The interim analysis for overall survival in the Phase 3 IMpactMF trial may occur in the second half of 2026.
- The final analysis for overall survival in the Phase 3 IMpactMF trial may occur in the second half of 2028.
- Potential delays and other adverse impacts caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges.
- Risks related to commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia.