G1 Therapeutics(GTHX)
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G1 Therapeutics(GTHX) - 2023 Q2 - Earnings Call Transcript
2023-08-02 16:27
Gil Blum - Needham & Company Kaveri Pohlman - BTIG Anupam Rama - JPMorgan Chase & Co. Troy Langford - TD Cowen Thank you, Jade. Good morning, everyone, and welcome to the G1 conference call to discuss our second quarter 2023 financial results and business update. The press release on these financial results was issued this morning and can be found in the News section of our corporate website, G1therapeutics.com. John Bailey Regarding the second goal, this is a particularly exciting time for G1. We presented ...
G1 Therapeutics(GTHX) - 2023 Q1 - Quarterly Report
2023-05-03 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________________ FORM 10-Q ______________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38096 ____________________________ ...
G1 Therapeutics(GTHX) - 2023 Q1 - Earnings Call Transcript
2023-05-03 19:07
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q1 2023 Earnings Conference Call May 3, 2023 8:30 AM ET Company Participants Will Roberts - Investor Relations Jack Bailey - Chief Executive Officer Andrew Perry - Chief Commercial Officer Raj Malik - Chief Medical Officer John Umstead - Chief Financial Officer Thank you for the clarification. And Raj maybe a couple for you here, so we are looking for the [indiscernible] data on May 12 at a poster. And itÂ's interesting, I mean, youÂ've been carefully guiding more importa ...
G1 Therapeutics(GTHX) - 2022 Q4 - Annual Report
2023-03-01 21:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________________ FORM 10-K ______________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR (Exact name of Registrant as specified in its Charter) ______________________________________________ o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 193 ...
G1 Therapeutics(GTHX) - 2022 Q4 - Earnings Call Transcript
2023-03-01 16:05
Financial Data and Key Metrics Changes - The company reported net sales of Cosela at $8.9 million for Q4 2022, representing an 8% vial volume growth compared to Q3 2022 and a 103% increase compared to Q4 2021 [3][97] - Total revenue for Q4 2022 was $10.3 million, up from $5.7 million in Q4 2021, with full-year revenue for 2022 at $51.3 million compared to $31.3 million in 2021 [108] - The company ended 2022 with cash and equivalents of $145.1 million, down from $221.2 million at the end of 2021, including $52 million from a public offering [23] Business Line Data and Key Metrics Changes - The company added nearly 100 new accounts in Q4 2022, with a total of 71 of the top 100 organizations having ordered Cosela to date [13][101] - The patient share for Cosela in the first-line market increased to approximately 9% in Q4 2022 [102] - The reorder rate for Cosela remained high at around 80% [13] Market Data and Key Metrics Changes - 77% of volume in Q4 2022 came from community clinics and hospitals, while 23% came from academic centers [28] - The company reported that 98% of its volume was in commercial supply, with only 2% through its patient assistance program [28] Company Strategy and Development Direction - The company is focused on three core goals: restoring volume growth, executing ongoing clinical trials, and capital preservation [9][36] - The strategy includes expanding the customer base in community clinic networks and enhancing operational efficiencies [15][103] - The company anticipates net product revenue for 2023 to be between $50 million and $60 million, reflecting a significant growth potential in the small cell lung cancer market [24][97] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Cosela in lung cancer, noting strong sales execution and continued volume growth into Q1 2023 [36][97] - The interim overall survival analysis for the pivotal TNBC trial is now expected in the first half of 2024 due to slower-than-anticipated event accumulation [19][57] - Management highlighted the importance of moving quickly from trial to adoption to drive success in the market [90] Other Important Information - The company has undergone a reduction in force of approximately 30% to extend its cash runway [26][98] - The CFO, Jen Moses, will resign but remain as a senior advisor for one year [38][58] Q&A Session Summary Question: What is the timeline for the interim readout of the pivotal breast cancer study? - The interim readout is delayed due to a slower accumulation of events, with the trial fully enrolled [40] Question: When can we expect data from the post-mortem analysis on the PRESERVE 1 study? - Active analyses are ongoing, and more information should be available in the upcoming months [41] Question: How is the company planning to drive growth with new accounts? - The company is focusing on standardization in EMRs and internal marketing from large organizations to drive adoption [42] Question: What has catalyzed the expanded use and adoption of Cosela? - Improved access, standardized EMRs, and the economic value proposition of Cosela have driven growth [51] Question: What is the average length of time a patient is on Cosela? - Patients tend to use Cosela for every cycle of treatment [76]
G1 Therapeutics (GTHX) Presents at the 41st Annual J.P. Morgan Healthcare Conference -- Slideshow
2023-01-12 16:42
- Categorized by lack of HR expression and HER2 gene amplification - Trilaciclib demonstrated robust survival benefit with chemo in Ph2 Chemo +/- targeted therapy remains first-line TNBC SoC - ~9k annual first-line drug treated TNBC patients in the U.S. - Targeted therapies only demonstrated benefit in subpopulations Trilaciclib demonstrated broad benefit in Randomized Phase 2 - Benefit observed across PD-(L)1+ and PD-(L)1- subpopulations - Patients receive 4 vials of trilaciclib for each 3-week cycle Poten ...
G1 Therapeutics(GTHX) - 2022 Q3 - Earnings Call Transcript
2022-11-02 17:31
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q3 2022 Earnings Conference Call November 2, 2022 8:30 AM ET Company Participants Will Roberts - VP, Communications Jack Bailey - CEO Raj Malik - CMO Andrew Perry - CCO Jen Moses - CFO Conference Call Participants Gil Blum - Needham & Company Dane Leone - RJF Ed White - H.C. Wainwright Malcolm Kuno - JPM David Nierengarten - Wedbush PacGrow Troy Langford - Cowen and Company Tony Butler - ROTH Capital Partners Operator Hello and thank you for standing by. Welcome to the G1 ...
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2022-09-16 21:17
Trilaciclib Potential & Clinical Pipeline - Trilaciclib has the potential to improve survival in combination with leading/emerging chemotherapy treatments by myeloprotection and immunomodulation[4] - The company anticipates initial results from multiple Phase 2 trials in 4Q 2022, including 1L bladder cancer, MOA, and ADC combination trials[4] - Phase 3 data readouts are expected in 1Q 2023 for 1L CRC and in 2H 2023 for 1L TNBC[4] COSELA Commercial Performance & Market Opportunity - In 2Q22, COSELA achieved $8.7 million in net sales, with nearly 60% vial volume growth QoQ[26] - G1 estimates a total market value of ~$700 million for COSELA in ES-SCLC, with a current penetration of ~4%[28] - Approximately 30,000 ES-SCLC patients are treated annually in the US, with 17,500 in 1L, 9,500 in 2L, and 2,500 in 3L[18] - COSELA has exceptional reimbursement coverage, with approximately 60% from Medicare, 30% from Commercial, and 10% from Medicaid/Other[18] Clinical Trial Data & Ongoing Studies - In a Phase 2 trial for mTNBC, trilaciclib demonstrated robust Overall Survival (OS) improvement, with hazard ratios of 0.31 and 0.40 compared to chemotherapy alone[8, 41] - In mTNBC study, for PD-L1 positive tumors, median OS was 32.7 months for gem/carbo + trilaciclib vs 10.5 months for gem/carbo alone, with a hazard ratio of 0.34[46] - The ongoing Phase 3 PRESERVE 1 trial in 1L CRC has completed enrollment of 326 participants, with initial results expected in 1Q 2023[40] - The ongoing Phase 3 PRESERVE 2 trial in 1L TNBC has a target enrollment of ~180 participants, with an interim OS analysis expected in 2H 2023[47, 48] Financial Position & Upcoming Milestones - The company had $144 million in cash and cash equivalents as of June 30, 2022, with an additional $25 million of debt facility available[55] - G1 anticipates a $13 million milestone payment in 3Q22 for trilaciclib approval in China, with potential for up to $156 million in milestones and double-digit royalties[55]
G1 Therapeutics(GTHX) - 2022 Q1 - Earnings Call Transcript
2022-08-03 18:32
Symbotic Inc. (SYM) Q3 2022 Earnings Conference Call August 1, 2022 5:00 PM ET Company Participants Will Roberts - Head-Corporate Communications Jack Bailey - CEO Jen Moses - CFO Andrew Perry - Chief Commercial Officer Raj Malik - Chief Medical Officer Conference Call Participants Gil Blum - Needham & Company Kaveri Pohlman - BTIG Tony Butler - ROTH Capital Edward White - H.C. Wainwright David Nierengarten - Wedbush Securities Anupam Rama - JPMorgan Troy Langford - Cowen Operator Good day, and thank you for ...
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2022-05-24 18:57
| --- | --- | --- | --- | |--------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | Optimizing Chemotherapy, | | | | | Advancing Survival | | | | | | | | | | May 4, 2022 | | | | | | | | | 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expre ...