G1 Therapeutics(US:GTHX)2021-11-03 17:20Financial Data and Key Metrics Changes - Total revenue for Q3 2021 was $4.9 million, consisting of net product revenue of $3.6 million and license revenue of $1.3 million [53] - Net sales of COSELA increased by 60% compared to the previous quarter [14] - Research and development expenses rose to $21.1 million from $17.9 million in Q3 2020, primarily due to increased clinical trial spending [56] - Selling, general and administrative expenses increased to $24.3 million from $18.4 million in Q3 2020, driven by commercialization activities and increased personnel costs [57] - Cash and cash equivalents at the end of Q3 2021 were $212 million, with an extended cash runway expected to last into 2024 [58][59] Business Line Data and Key Metrics Changes - COSELA is experiencing strong adoption, with over 75% of demand coming from community hospitals or clinics [23] - The company has received orders from over 100 unique organizations, up from 68 at the end of June [23] - Awareness of COSELA remains high, with 55% unaided awareness and 75% aided awareness among oncologists [25] Market Data and Key Metrics Changes - The reimbursement landscape is favorable, with approximately 80% of on-label patient lives covered by payer policies [21] - Four of the top five U.S. payers have made positive coverage decisions since COSELA's availability [21] - The company is focusing on the top 100 organizations that treat over half of patients with extensive-stage small cell lung cancer [15] Company Strategy and Development Direction - The company is hiring a dedicated sales team to improve access to key accounts and drive adoption of COSELA [31] - Two new Phase 2 clinical trials for trilaciclib are set to begin, focusing on maximizing future applicability [64] - The company has made a strategic decision to discontinue a Phase 2 trial in second and third-line non-small cell lung cancer to reallocate resources to more promising studies [48] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the need for improved execution to convert physician awareness and intention into actual usage of COSELA [63] - The company is optimistic about the potential of COSELA based on positive feedback from physicians and patients [30] - Management is committed to addressing recent sales softness and believes that current actions will positively impact uptake [36] Other Important Information - The company has a robust investigator-initiated study program to explore various areas of scientific importance [49] - The new permanent J Code for COSELA, effective October 1, provides reassurance for community clinics considering adoption [22] Q&A Session Summary Question: Are there any biomarkers planned to study in colorectal cancer? - The primary endpoint is myelosuppression, with 20% of the alpha allocated to anti-tumor efficacy [68] Question: Can a solid tumor study for myeloprotection be run for late-line patients? - Myeloprotection is being evaluated in all studies, including those for triple-negative breast cancer and bladder cancer [72]