GERON CORP Q3 FY2024 earnings call

• Commercial Launch: RYTELO had a successful U.S. launch with $28.2 million in net product revenue in Q3, exceeding expectations. Demand increased month-over-month. • Financial Transactions: Completed a $250 million synthetic royalty transaction with Royalty Pharma and a $250 million senior secured debt facility with Pharmakon Advisors, with $250 million in gross proceeds received. The royalty to Royalty Pharma is capped and has specific terms based on sales. The debt facility allows borrowing up to $250 million with $125 million drawn initially. • Clinical Trials: The pivotal imetelstat Phase 3 IMpactMF trial for relapsed/refractory myelofibrosis was ~70% enrolled as of Aug 2024, with interim analysis expected in early 2026 and final in early 2027. ASH abstracts highlighted new data on imetelstat in various myeloid hematologic malignancies. • EU Commercialization: CHMP review of RYTELO's marketing authorization application in lower-risk MDS could be completed in late 2024/early 2025 with potential EU approval in H1 2025, planning to commercialize in select EU markets in 2026.

In the third quarter, Geron achieved $28.2 million in RYTELO net product revenue from its first full quarter on the market in the U.S. This revenue comes solely from the commercial launch of RYTELO, the first-in-class telomerase inhibitor.

• Growth: Expect steady and consistent growth across patient segments, including second line, first line ESA ineligible, and relapsed/refractory third line plus patients. • EU Timeline: Planning to commercialize RYTELO in select EU markets beginning in 2026 subject to regulatory approval. • Financial Flexibility: The financing transactions provide critical flexibility to fuel growth and investment, with scenarios where they can lead to profitability without additional equity financing.

• Actual results could differ materially from forward-looking statements due to factors identified in Geron's most recent periodic report filed with the SEC, including those related to clinical trial outcomes, regulatory approvals, and market adoption.

Q: Given what was seen this quarter, could you give a better idea of how growth cadence could look over the next few quarters or year, and how growth assumptions and market for RYTELO factored into the royalty deal?

A: Jim Ziegler said they expect steady consistent growth across patient segments. Michelle Robertson said the royalty deal terms were based on current internal forecast.

Q: Clarify royalty percentage rates and cash runway expectations?

A: Michelle Robertson said the royalty rate is competitive, and there are scenarios where the transactions can take them to breakeven without additional equity financing, maintaining over 12-months of cash.

Q: Clarify what steady growth means in terms of patient growth and which patients are coming on therapy?

A: Jim Ziegler said growth across all patient segments, including first line ESA ineligible, second line, and third line, with steady consistent growth expected.

Q: Impact of inventory and breadth/depth of prescribing?

A: Jim Ziegler said inventory is between 2-4 weeks, and they're early in launch with breadth seen and expecting depth over time.

Q: Elaborate on royalty and debt structure choice over equity raise?

A: Michelle Robertson said it was a result of competitive process, reducing dependency on equity markets and paying off unfavorable existing debt.

Q: Early real world experience on transfusion reductions, safety, and luspatercept impact?

A: Jim Ziegler said real world performance is consistent with trials, and luspatercept in first line doesn't affect RYTELO's position in second line.

Q: Utilization split between academics and community, dose management, and gross-to-net?

A: Jim Ziegler said 65/35 split between community and academic, cytopenia management is well understood. Michelle Robertson said gross-to-net was ~14% in Q3 and expects mid-double digits, with COGS to be mid-single digits long term.

Q: Plan with additional capital and profitability including myelofibrosis?

A: Michelle Robertson said capital allows investment in redundancy and EU launch preparation, and profitability assumptions include myelofibrosis in internal projections