Geron(US:GERN)2025-11-05 14:00Financial Data and Key Metrics Changes - For Q3 2025, total net revenue was $47 million, an increase from $28 million in Q3 2024 [23] - Cash and marketable securities as of September 30, 2025, were approximately $420 million, down from $503 million as of December 31, 2024 [23] - Research and development expenses for Q3 2025 were $21 million, compared to $20 million for the same period in 2024 [24] - Selling, general and administrative expenses for Q3 2025 were $39 million, up from $36 million in Q3 2024 [24] - The company expects total operating expenses for fiscal year 2025 to be between $250 million and $260 million, below previous guidance of $270 million to $285 million [24] Business Line Data and Key Metrics Changes - Net product revenue for Rytelo was $47.2 million for Q3 2025, with a 3% decrease in demand compared to the previous quarter [5][6] - New patient starts in first and second lines increased to 36% from 30% in Q2 2025, but did not offset discontinuations in later lines [6] - Prescribing accounts increased by 15% in Q3, adding approximately 150 new ordering accounts, bringing the total to 1,150 [6] Market Data and Key Metrics Changes - The company completed its first shipment of Rytelo to Germany under a named patient early access program, preparing for commercialization in select EU markets in 2026 [7] - The company is focusing on increasing awareness of Rytelo among US healthcare providers (HCPs) and expanding its presence in hematology forums [9][10] Company Strategy and Development Direction - The company aims to maximize the impact of Rytelo for patients while advancing its first-in-class telomerase inhibitor to benefit more patients in the future [12] - Key strategic initiatives include increasing awareness among US HCPs, expanding relationships with key opinion leaders (KOLs), and enhancing community site penetration [16][18] - The company is also focusing on investigator-sponsored trials to broaden the clinical evidence base for imetelstat [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the need for improved execution and alignment to drive Rytelo's growth [12][26] - The company acknowledges that building brand awareness and shifting physician behavior takes time, with a focus on 2026 as a growth story [64][65] - Management is confident in the potential of Rytelo to address unmet needs in lower-risk MDS patients [28][62] Other Important Information - The company has identified four initial actions to enhance execution and support future revenue growth, including increasing awareness and education for HCPs [9] - The company plans to engage with patient advocacy organizations and professional societies to raise awareness about lower-risk MDS and Rytelo [15] Q&A Session Summary Question: Insights on current gross-to-net and demand decrease - Management confirmed that the mid-to-high teens range for gross-to-net remains applicable and discussed factors affecting demand, including discontinuations in later lines [32][35] Question: Growth in ordering accounts and prescribing depth - Management reported a 15% sequential increase in ordering accounts, with 80% of accounts having reordered in the last quarter, emphasizing the need for depth in prescribing [41][43] Question: Revised operating expense guidance - Management highlighted savings from CMC investments and slowed infrastructure investments, confirming a revised operating expense guidance of $250 million to $260 million for 2025 [49][50] Question: Sales force effectiveness and EU partner search - Management confirmed the sales force is fully hired and focused on effectiveness, while ongoing discussions for EU partnerships are taking place [53][56] Question: Confidence in awareness as a growth lever - Management expressed high confidence in identifying issues and emphasized that increasing brand awareness is crucial for growth, with 2026 seen as a pivotal year [61][64]