Geron (NASDAQ:GERN) management used its fourth-quarter 2025 earnings call to outline how strategic alignment work completed in 2025 is expected to support RYTELO demand growth in 2026 while lowering the company’s expense base following a December restructuring.
RYTELO results and 2026 outlook
Chief Executive Officer Harout Semerjian said RYTELO net revenue in the fourth quarter was $48 million, which he described as in line with expectations. For the full year 2025, Geron reported $184 million in RYTELO net revenue, which Semerjian called “a meaningful number for a hematology drug in its first full commercial year.”
Commercial strategy targets second-line, lower-risk MDS
Chief Commercial Officer Ahmed ElNawawi said RYTELO’s 2025 performance provides a base to “further grow demand in 2026.” He highlighted several fourth-quarter commercial metrics discussed on the call, including 9% demand growth versus the third quarter and a 13% increase in prescribing accounts, expanding Geron’s footprint to approximately 1,300 accounts. Management also said first- and second-line patient starts on a rolling 12-month basis were about 30%.
ElNawawi said Geron views market conditions as favorable in second-line, lower-risk MDS, noting that movement of luspatercept into the first-line setting has “clarified” the second-line opportunity for RYTELO. He estimated the eligible second-line, lower-risk MDS patient population at approximately 8,000 patients in the U.S., which he described as the company’s primary commercial focus in 2026.
Geron framed its 2026 commercial execution around three core initiatives:
- Targeted engagement with high-volume community accounts, prioritizing centers treating earlier-line and second-line patients, while using more digital tactics for lower-volume or salvage-focused accounts.
- Increased investment in marketing channels the company считает most effective, including digital, non-personal promotion, and third-party educational platforms—what management referred to as a “3D surround sound” approach.
- Cross-functional account management incorporating ASH 2025 data, including proactive discussion of cytopenias and messaging positioning RYTELO as a standard-of-care option for appropriate second-line patients “regardless of their RS status.”
In the Q&A, Semerjian pointed to the fourth-quarter demand growth figure as a “forward-looking” metric the company watches closely, adding that what the company has seen from IQVIA and other sources has been “in line with our expectation,” though he declined to comment on first-quarter results.
When asked about competitive dynamics, Chief Medical Officer Joseph Eid said that with luspatercept becoming more dominant in the first line, Geron is seeing a shift away from a historical sequence of ESAs and luspatercept. Eid added that, from a biological and physician-feedback perspective, ESAs “do not work as well” after luspatercept, and key opinion leaders are moving from luspatercept to imetelstat as a preferred second-line option rather than to an ESA.
Medical affairs, evidence generation, and IMpactMF timing
Eid said medical and scientific engagement in 2025 increased RYTELO’s “share of voice” in hematology and that Geron plans continued engagement through 2026, including education at meetings such as SOHO and smaller peer-to-peer forums.
He also referenced analyses from the IMerge program and said data presented at ASH 2025 suggested treatment-emergent cytopenias are consistent with “on-target activity,” which management said helps inform clinical practice and engagement.
Geron said it is supporting over 10 investigator-sponsored trials (ISTs) and real-world evidence initiatives spanning mechanistic studies, combination and sequencing approaches, earlier-line use, and new settings. Eid said the company expects initial real-world evidence data in the second half of 2026.
On pipeline development, Eid said the fully enrolled IMpactMF trial in relapsed/refractory myelofibrosis is projected to reach its interim analysis “death event trigger” in the second half of this year, with overall survival as the primary endpoint. Management’s base-case planning assumption remains progression to a final analysis in the second half of 2028, while noting an earlier positive outcome would be an upside scenario.
Expenses, restructuring, and liquidity
Robertson said fourth-quarter and full-year 2025 results reflected both commercial progress and expense discipline. Full-year 2025 total operating expenses were approximately $255 million, in line with prior guidance of $250 million to $260 million.
For 2026, Geron guided to total operating expenses of $230 million to $240 million, representing about a $20 million year-over-year reduction at the midpoint. Robertson said the strategic restructuring announced in December 2025 has been completed and that Geron accounted for substantially all related expenses in the fourth quarter.
Additional financial details cited on the call included:
- Gross-to-net deductions increased to 17.7% for 2025 versus 14.5% in the prior year, driven by wider 340B utilization and expanded GPO contracting; the company expects gross-to-net in the high teens to low twenties in 2026.
- R&D expense was $16 million in Q4 and $74 million for 2025, down from $23 million and $104 million, respectively, in 2024. Management attributed the year-over-year change to lower clinical trial costs and manufacturing expenses after approval of RYTELO enabled inventory capitalization.
- SG&A expense was $42 million in Q4 and $159 million for 2025, compared with $43 million and $146 million in 2024, reflecting increased sales and marketing headcount and marketing program investment.
- Cash, cash equivalents, restricted cash, and marketable securities totaled approximately $400 million at Dec. 31, 2025, compared with $503 million a year earlier.
Robertson also said an amendment to Geron’s Pharmakon loan agreement extended potential access to an additional $125 million in capital through July 30, 2026. She added the company plans to file a new shelf registration and at-the-market program with its 10-K on Feb. 27.
In response to a question about potential profitability, Robertson said the company sees a “path to profitability,” but it is “not our focus in 2026,” emphasizing continued investment in commercialization and additional IST work given the company’s balance sheet.
Europe comments: approval in hand, strategy still developing
Semerjian said Geron has a European approval that enables engagement outside the U.S., but he cautioned that approval “without funding” limits the near-term impact. He said the company is working to understand health technology assessment (HTA) processes and the ability to support pricing consistent with the value management believes RYTELO provides, while also having conversations with potential partners. He described the European approach as opportunistic and reiterated that the company remains focused on driving U.S. growth while ex-U.S. discussions continue.
About Geron (NASDAQ:GERN)
Geron Corporation (NASDAQ: GERN) is a clinical-stage biotechnology company dedicated to developing and commercializing novel treatments that target telomerase, an enzyme critical to cancer cell immortality. The company’s research is focused on hematologic malignancies and solid tumors, with a pipeline designed to address diseases that have historically had limited therapeutic options.
The lead product candidate, imetelstat, is a first-in-class telomerase inhibitor currently in Phase II and Phase III clinical trials for myelofibrosis and myelodysplastic syndromes.
