GERON CORP Q1 FY2025 earnings call

Key Points

• RYTELO U.S. commercial launch success is the top corporate priority. Q1 RYTELO net revenues were 39.4M, down from Q4 due to inventory drawdown.
• Three key strategies to integrate sales growth: investing in brand awareness among top hematologists, refining marketing and medical efforts to enhance prescribing clarity, and implementing programs to expand U.S. KOL support.
• EU commercialization is a priority with a small team focused on EU4 launch preparation, pending favorable reimbursement.
• IMPACT MS Phase III trial evaluating imetelstat in relapsed refractory myelofibrosis, with interim analysis expected in second half of 2026.
• Financials: Q1 research and development expenses 15.1M vs 29.4M in 2024, SG&A expenses 40M vs 27.1M in 2024; FY2025 operating expenses expected to be 270M - 285M.

RYTELO was the key segment. Q1 RYTELO net revenues were 39.4 million, down 8 million from Q4. Demand in the 13-week period through March 28th was relatively flat at +1% versus prior 13 weeks. RYTELO's revenue contribution is significant as it's the company's main product for treating lower risk MDS.

Forward-Looking Statements

• Increased commercial investments to bolster uptake across prescribers and drive long-term demand.
• Anticipate commercialization in select EU4 countries starting in 2026 pending favorable reimbursement.
• Interim analysis of IMPACT MS Phase III trial expected in second half of 2026.
• Expect to evaluate timeline for achieving profitability as sales trajectory is monitored.

Risks

• Inventory drawdown impact on Q1 revenues could affect short-term performance.
• Success in EU commercialization dependent on strong reimbursement and favorable pricing.
• Clinical trial outcomes of IMPACT MS could impact future commercial potential if not successful.

Q: How are Q2 expectations and the cadence of efforts leading to inflection viewed?

A: Jim Ziegler mentioned that changes made will start to have impact, with reps anticipated in the field beginning in Q3 and seeing impact later in the year, with continued momentum building into Q2 and sustaining through 2025.

Q: Any specific push-backs from physicians regarding RYTELO?

A: Jim Ziegler stated that for physicians not using or educated on RYTELO, barriers like cytopenias were cited, but change when they've treated or know about RYTELO. Joseph Eid added that barriers shift when discussing mechanism of action and cytopenias being on target.

Q: What's the day supply of inventory at the end of Q1?

A: Michelle Robertson said at the end of Q4 inventory was on the higher end of 3.5 weeks, and at the end of Q1 was on the lower end of [indiscernible] weeks.

Q: How sustainable is the 10% demand increase seen in April?

A: Joseph Eid said it's a promising data point, but the key is to sustain growth through strong execution, with expectations to return to growth based on delivering the right message to the right physician.