Geron's Q4 2024: Revenue Growth, Label Expansion, and Financial Guidance Inconsistent

These are the key contradictions discussed in Geron's latest 2024Q4 earnings call, specifically including: Revenue Growth Trends, Label Expansion Strategies, Revenue Trends and Patient Dynamics, and Enrollment Challenges:



Rytelo Revenue Trends:
- Geron achieved $47.5 million in Rytelo net product revenue in Q4 2024, exceeding internal expectations for the full year with $76.5 million.
- However, the company observed flat revenue trends over the last few months, with no significant week-over-week growth in January or February.
- The flat revenue trends were attributed to a lack of new patient starts, particularly in the second line, and regional variations in territory and account performance.

Payer Access and Market Potential:
- Payers responsible for approximately 80% of U.S. covered lives have implemented medical coverage policies for Rytelo, supporting strong payer access.
- The U.S. Rytelo total addressable lower-risk MDS patient population is estimated to be 15,400 patients in 2025, with a potential for Rytelo to achieve blockbuster status by treating approximately 1/3 of these patients.
- Payer access and market potential were positively influenced by the favorable FDA label, NCCN guidelines, and strong payer coverage policies.

Commercial and Medical Affairs Leadership Changes:
- The company changed its commercial and medical affairs leadership a few months into the launch, hiring experienced senior leadership to drive operational excellence and minimize launch disruption.
- Augmentations include [Don Win] as Senior Vice President, Commercial Strategy and Operations, and [Jim Hassard] as Senior Vice President, Sales and Marketing.
- These changes aimed to improve insights, strategy, and execution to better capture the significant commercial opportunity for Rytelo in lower-risk MDS.

Myelofibrosis Clinical Advancements:
- The IMpactMF trial in myelofibrosis achieved 80% enrollment, with an expected interim analysis in the second half of 2026 and final analysis in the second half of 2028.
- The Phase I IMproveMF trial demonstrated the tolerability of imetelstat combined with Jakavi, with imetelstat selected for dose confirmation and expansion.
- These advancements in myelofibrosis clinical trials are part of Geron's strategy to expand the commercial opportunity for Rytelo through positive trial outcomes.