G1 Therapeutics(US:GTHX)2024-05-01 16:04Financial Data and Key Metrics Changes - Net sales of COSELA for Q1 2024 were $14.1 million, a 34% increase from $10.5 million in Q1 2023 [16] - Total revenue for Q1 2024 was $14.5 million, compared to $12.9 million in Q1 2023 [16] - Operational cash burn for the quarter totaled approximately $8 million, with an expected year-end cash balance of $50 million to $60 million [17][18] Business Line Data and Key Metrics Changes - Overall vial volume growth was 4% compared to Q4 2023, attributed to fewer new patients added during the holiday period [8][58] - The company added over 50 new accounts, maintaining a patient share of around 13% in the first-line market [66][92] - Significant growth was observed in the strategic accounts function, which grew over 20% during the quarter [65] Market Data and Key Metrics Changes - The company added two new top 100 customers during Q1, bringing the total to 78 out of the top 100 that have ordered COSELA [11][92] - The West Region saw almost 13% growth, with three territories growing more than 15% [91] Company Strategy and Development Direction - The company aims to build category leadership in triple-negative breast cancer (TNBC) and is focused on upcoming data readouts from ongoing trials [59][99] - The strategy includes expanding the usage of COSELA in extensive-stage small cell lung cancer and enhancing existing contracts [4][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the 2024 net sales guidance of $60 million to $70 million despite short-term challenges [58][99] - The company anticipates a cash runway extending into Q3 2025, including costs related to TNBC filing and launch [18][71] Other Important Information - The company out-licensed global rights to lerociclib to Pepper Bio, expecting upfront payments and milestone payments totaling up to $135 million [98] - The final results from the Phase 3 PRESERVE 2 trial are expected late in Q2 2024, with plans for a supplemental NDA filing if results are positive [14][73] Q&A Session Summary Question: What were the challenges faced in Q1 regarding patient enrollment? - Management noted that the slow start in patient enrollment was due to the holiday period affecting new patient additions, but they are confident in improving execution moving forward [75] Question: How will the inclusion of Ukrainian patients affect the trial data? - Management confirmed that the FDA recommended including events from Ukrainian patients in the overall survival analysis, which may impact the timeline for results [25][68] Question: What is the expected chemotherapy treatment duration for TNBC patients compared to lung cancer? - The median number of chemotherapy cycles for TNBC is around eight, with a cumulative dose significantly higher when combined with trilaciclib [45] Question: How does the company plan to address accounts not currently using COSELA? - The company continues to add top accounts and leverage real-world evidence to drive adoption among those not currently using COSELA [27] Question: What is the market share for COSELA in second-line settings? - Approximately 90% of COSELA's use is in the first-line setting, with about 10% in second-line settings, indicating a consistent market share across both [121]