Geron Corporation Q2 FY2025 earnings call

• Commercial strategies for RYTELO: Priorities include increasing brand awareness among hematologists treating lower-risk MDS patients, ensuring physicians have comprehensive understanding of prescribing RYTELO, and expanding U.S. KOL support. The sales force and medical affairs organization have been expanded, with new hires trained and deployed. EU strategy: Focus on HTA submissions, EAP programs, and commercial distribution; pending favorable pricing and reimbursement, will take a measured approach to launch in select EU4 countries.
• Clinical development: Enrollment in the Phase III IMpactMF trial is expected to be completed by year-end; medical affairs team doubled in size, with efforts to enhance community awareness, HCP confidence, and KOL advocacy.
• Financials: As of June 30, 2025, cash and marketable securities were $433 million; RYTELO net revenues $49 million; R&D expenses $22 million; SG&A expenses $39 million; expects total operating expenses for 2025 to be $270 million to $285 million.

RYTELO net revenues in Q2 2025 were $49 million, representing an increase of approximately 24% over the first quarter. This growth was driven by increased demand from new patient starts. At the end of Q2, inventory remained within the target range of 2 to 4 weeks.

• Expect the expanded sales and medical affairs teams to begin having an impact by year-end.
• Pending favorable pricing and reimbursement, will take a measured approach to commercialization in select EU4 countries and not launch independently in Europe.
• Maintain financial discipline in investments for planned EU4 launch.

• Actual events or results could differ materially from forward-looking statements as identified in Risk Factors in Geron's most recent periodic report.
• Challenges in achieving favorable pricing and reimbursement in EU markets.
• Uncertainties in translating commercial strategies into sustained growth in RYTELO prescriptions.

Q: How is the EU commercialization strategy progressing and any comments on partners?

A: Jim Ziegler said the top priority is securing favorable reimbursement in EU countries. Engaged with partners on HTA, EAP, and distribution, maintaining financial discipline in investments and currently engaged with a partner for potential EU4 commercialization.

Q: Contextualize the 30% second and first-line patients in May and leading metrics for sales team recalibration?

A: James Ziegler said the source is IQVIA claims data based on rolling 3-month average, and leading metrics for sales team include sales performance at regional/territory level, reach/frequency, and calls on top targets and physicians.