Geron(GERN)2025-05-07 13:00Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $457.5 million in cash, cash equivalents, restricted cash, and marketable securities, down from $502.9 million as of December 31, 2024 [43] - Total net product revenue for Q1 2025 was $39.4 million, a decrease of $8 million from Q4 2024, attributed to an inventory drawdown among distributors [43][44] - Research and development expenses for Q1 2025 were $15.1 million, compared to $29.4 million for the same period in 2024, primarily due to lower clinical trial costs [44][45] - Selling, general, and administrative expenses increased to $40 million in Q1 2025 from $27.1 million in the same period last year, mainly due to higher personnel expenses [45] Business Line Data and Key Metrics Changes - Q1 Rytello net revenues were $39.4 million, down from Q4, with demand relatively flat at a 1% increase compared to the previous thirteen weeks [6][44] - Approximately 900 sites of care utilized Rytello as of April 2025, an increase of almost 300 new sites since the end of Q4 [24] - Demand grew approximately 10% in the four-week period ending April 25 compared to the prior four-week period, marking the highest month-over-month growth since October 2024 [25] Market Data and Key Metrics Changes - The estimated U.S. total addressable market for Rytello is approximately 15,400 lower-risk MDS patients, with significant opportunities to expand use in earlier lines of treatment [15] - In Europe, the estimated total addressable market for Rytello is approximately 80% of the U.S. market [15] - Approximately 85% of U.S. covered lives are now under favorable Rytello medical coverage policies consistent with FDA label and NCCN guidelines [26] Company Strategy and Development Direction - The company's top priority is the successful commercialization of Rytello in the U.S., with plans to increase brand awareness and refine marketing efforts [5][17] - The company is pursuing a disciplined path for EU commercialization, planning to engage third-party partners to minimize investment while focusing on U.S. efforts [11][28] - The ongoing Phase III trial for Imetelstat in relapsed-refractory myelofibrosis could potentially double the commercial opportunity for Rytello if successful [12][48] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q1 sales were modest and do not reflect the product's true commercial potential, emphasizing the commitment to making Rytello part of the standard of care [47] - The company is encouraged by early performance indicators and is ready to make adjustments to improve commercial execution [47] - The interim analysis for the Phase III trial is expected in the second half of 2026, with management optimistic about the potential outcomes [49] Other Important Information - The company is in the process of identifying a permanent CEO, with a decision expected within the next six months [12] - The company plans to maintain financial discipline while investing in the commercialization strategy for Rytello [46] Q&A Session Summary Question: What are the expectations for Q2 given the inventory impacts and demand improvements? - Management noted that inventory issues have been addressed and expects continued momentum into Q2, with new commercial representatives expected to impact later in the year [50][53] Question: Can you comment on commercial efforts to promote switching to Rytello? - Management highlighted that awareness and education are key, with positive shifts in perceptions regarding Rytello's efficacy and cytopenia management among physicians [56][58] Question: What is the current status of inventory levels? - The inventory at the end of Q1 was on the lower end of two to two and a half weeks, indicating a drawdown from the higher levels seen previously [93] Question: Are new patient starts exceeding discontinuations? - Management indicated that while there is no perfect data, new patient starts are promising, with approximately 25% of new starts occurring in the first and second lines of therapy [96] Question: What drove the incremental cash burn in Q1? - The cash burn was higher due to payouts of bonuses and early investments in inventory, typical for Q1 [97]