• Rytelo Net Product Revenue (Q4 2024): $47.5 million.
• Rytelo Net Product Revenue (Full Year 2024): $76.5 million.
• Total Net Revenue (Q4 2024): $47.5 million.
• Total Net Revenue (Full Year 2024): $77 million.
• Cash Position (End of 2024): Approximately $503 million.
• Total Operating Expenses (Q4 2024): $67.6 million.
• Total Operating Expenses (Full Year 2024): $250.7 million.
• Cost of Goods Sold (Q4 2024): Approximately $783,000.
• Cost of Goods Sold (Full Year 2024): $1.3 million.
• Research and Development Expenses (Q4 2024): $23.4 million.
• Research and Development Expenses (Full Year 2024): $103.7 million.
• Selling, General and Administrative Expenses (Q4 2024): $43.4 million.
• Selling, General and Administrative Expenses (Full Year 2024): $145.7 million.
• Expected Operating Expenses (Fiscal Year 2025): $270 million to $285 million.

• Warning! GuruFocus has detected 6 Warning Signs with GERN.

Release Date: February 26, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Geron Corp (NASDAQ:GERN) achieved FDA approval for Rytelo in June 2024, marking a significant milestone for the company.
• Rytelo received favorable placement in the MDS NCCN guidelines, including a Category 1 treatment recommendation.
• The company reported $47.5 million in Rytelo net product revenue in Q4 2024, exceeding internal expectations.
• Geron Corp (NASDAQ:GERN) ended the year with a strong cash position of approximately $503 million, which is expected to support profitability without additional financing.
• The Phase III IMpactMF trial for imetelstat in myelofibrosis is 80% enrolled, with potential to transform treatment for relapsed/refractory myelofibrosis patients.

Negative Points

• Despite initial success, Geron Corp (NASDAQ:GERN) observed flat revenue trends for Rytelo over the last few months.
• The majority of new patient starts for Rytelo have been in the third-line plus segment, with lower than expected starts in the second line.
• There is variability in regional and account-level performance, indicating inconsistent uptake across different territories.
• The company had to change its commercial and medical affairs leadership a few months into the Rytelo launch, indicating potential initial missteps.
• Geron Corp (NASDAQ:GERN) has not provided specific revenue guidance for 2025, citing the need for more quarters of data to establish reliable forecasts.

Q & A Highlights

Q: Can you provide insights on the recent revenue trends and expectations for the first quarter of 2025? A: Jim Ziegler, Executive Vice President and Chief Commercial Officer, noted that revenues have shown variability week-over-week, but the four and eight-week rolling averages indicate flatness. This trend continued into the period leading up to the call. It's too early to make a definitive call on Q1 revenues, but the past few months have been relatively flat.

Q: Are there any specific reasons for the flat revenue trends, and what actions are being taken to address them? A: Jim Ziegler explained that the flatness is primarily due to new patient starts, particularly in the second line, being lower than expected. The company is focusing on increasing new patient starts across all lines of therapy, especially in the ESA relapsed/refractory RS-negative patient segment. Efforts include optimizing engagement with healthcare providers and enhancing sales training.

Q: What feedback are you receiving from key opinion leaders (KOLs) regarding the use of Rytelo in earlier lines of therapy? A: Jim Ziegler stated that feedback from KOLs and physicians who have used Rytelo is positive, with the consensus being that "Rytelo works." The main challenge is increasing awareness and education among physicians, particularly in the community setting, to drive broader adoption.

Q: How is the company planning to address the challenges in the US market before expanding internationally? A: John Scarlett, Chairman and CEO, emphasized that the primary focus is on the US market. The company is concentrating on getting new patient starts on track and ensuring appropriate utilization in areas of high unmet need. While some pre-work for Europe is underway, the majority of efforts are directed towards the US.

Q: Can you comment on the operational expenses for 2025 and any potential impact from increased outreach efforts? A: Michelle Robertson, Chief Financial Officer, mentioned that the company has accounted for additional investments in medical affairs and other programs in the 2025 budget. There is flexibility to reallocate funds within the budget to support outreach efforts without changing the overall operational expense guidance.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.