G1 Therapeutics(GTHX)
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G1 Therapeutics(GTHX) - 2021 Q4 - Earnings Call Transcript
2022-02-23 19:22
Financial Data and Key Metrics Changes - Total revenue for Q4 2021 was $5.8 million, consisting of net product revenue of $4.4 million and license revenue of $1.4 million [56] - Total revenues for the full year 2021 were $31.5 million, with licensing revenue of $20.4 million and net product revenue of $11.1 million from COSELA sales [56] - Research and development expenses for Q4 2021 were $19.8 million, up from $16.4 million in Q4 2020, primarily due to increased clinical trial spending [58] - Selling, general and administrative expenses for Q4 2021 were $23.2 million, a decrease from $24.3 million in Q4 2020, attributed to reduced commercialization activities [59] - Cash and cash equivalents at the end of 2021 were $221.2 million, compared to $207.3 million at the end of 2020, expected to fund operations into 2024 [60] Business Line Data and Key Metrics Changes - COSELA net sales for Q4 2021 were $4.4 million, representing a 22% growth period-over-period [19] - The reorder rate for COSELA was around 75% for the entire year 2021, with over 80% in the most recent 13 weeks among the top 100 organizations [31] - Adoption of COSELA increased to 50 of the top 100 accounts by the beginning of 2022, up from 35% at the end of Q3 2021 [29] Market Data and Key Metrics Changes - Over 85% of oncologists indicated intent to use COSELA within the next 12 months, with over 50% planning to use it within six months [21] - The total market value for extensive stage small cell lung cancer patients is estimated at over $700 million [24] Company Strategy and Development Direction - The company is transitioning to a fully independent sales team for COSELA, moving away from the previous co-promotion partner [9] - The focus for 2022 includes driving both breadth and depth of COSELA usage among oncologists and oncology nurses [12] - The company plans to announce initial data from pivotal Phase 3 trials and several Phase 2 trials throughout 2022 [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the new sales team's ability to drive growth and establish relationships with key accounts [62] - The company remains comfortable with analyst expectations for COSELA net sales in 2022, anticipating growth primarily in the second half of the year [62] - Management highlighted the importance of clinical and economic benefits of trilaciclib, with ongoing studies expected to yield significant data in the coming year [64] Other Important Information - The company has made strategic decisions to enhance its sales force and improve engagement with oncologists [25] - Initial results from several clinical trials are expected to be announced in 2022, including studies on trilaciclib in various cancer types [64] Q&A Session Summary Question: Thoughts on potential benefits from COVID tapering for the sales force - Management noted an improvement in in-person sales calls as COVID restrictions eased, which could benefit the new sales team [70] Question: Difficulties with earlier sales arrangements - Management indicated that access to top accounts was a key issue previously, which the new sales team is addressing effectively [73] Question: Accelerated timelines for clinical trials - Management attributed faster enrollment to excitement around the protocol and effective team execution [75] Question: Biomarkers in bladder cancer study - The study will include archival data for PD-L1 expression and peripheral blood markers [81] Question: Impact of discontinuing second-line TNBC cohort - Management confirmed that the first-line arm of the trial remains unaffected by the discontinuation of the second-line cohort [82] Question: Expectations for SG&A expenses in the first quarter - An increase in expenses is expected due to the full deployment of the sales team and the transition away from the BI agreement [87] Question: Potential for broader myelopreservation label - Management indicated that discussions with the FDA will continue as data from ongoing studies becomes available [118]
G1 Therapeutics(GTHX) - 2021 Q3 - Earnings Call Presentation
2021-11-03 19:33
1 | --- | --- | |--------------------------|-------| | | | | | | | | | | Optimizing Chemotherapy, | | | | | | Advancing Survival | | | November 2021 | | 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 expressions referencing future events, conditions or circumstances) a ...
G1 Therapeutics(GTHX) - 2021 Q3 - Earnings Call Transcript
2021-11-03 17:20
Financial 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]
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2021-08-13 15:52
1 | --- | --- | --- | |--------------------------|-------|-------| | | | | | | | | | Optimizing Chemotherapy, | | | | Advancing Survival | | | | August 2021 | | | 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 expressions referencing future events, conditions or circum ...
G1 Therapeutics(GTHX) - 2021 Q2 - Earnings Call Transcript
2021-08-05 03:19
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q2 2021 Earnings Conference Call August 4, 2021 4:30 PM ET Company Participants William Roberts - VP, IR & Corporate Communications John Bailey - CEO, President & Director Jennifer Moses - CFO Rajesh Malik - Chief Medical Officer and SVP of R&D Conference Call Participants Chad Messer - Needham & Company Joseph Thome - Cowen and Company Thomas Shrader - BTIG David Nierengarten - Wedbush Securities Tony Butler - Roth Castle Operator Good day. Thank you for standing by, and ...
G1 Therapeutics(GTHX) - 2021 Q1 - Earnings Call Transcript
2021-05-06 03:09
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q1 2021 Earnings Conference Call May 5, 2021 4:30 PM ET Company Participants Will Roberts - Head of Investor Relations Jack Bailey - Chief Executive Officer Soma Gupta - Chief Commercial Officer Raj Malik - Chief Medical Officer Jennifer Moses - Chief Financial Officer Conference Call Participants Anthony Butler - ROTH Capital Chad Messer - Needham & Company Joe Thome - Cowen & Company Ed White - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by and ...
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2021-03-18 16:52
COSELA (Trilaciclib) Overview - COSELA is the first and only therapy to help protect against chemotherapy-induced myelosuppression for ES-SCLC patients receiving certain chemotherapy treatments [7] - COSELA demonstrated meaningful benefits across studies, including reduced rates of hematologic adverse events and improved immune response [16] - COSELA is approved by the U S Food and Drug Administration to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with ES-SCLC [23] Financial Status and Objectives - The company had $207 million in cash on hand as of December 31, 2020, with an additional $86 4 million in net proceeds from Cowen ATM during 1Q21 [7] - A key objective is to establish COSELA as the Standard of Care for ES-SCLC patients in the U S [21, 22, 35, 36, 42, 53, 56] - The company aims to maximize the long-term value of COSELA by executing a robust development plan [21, 22, 35, 36, 42, 53, 56] Clinical Trial Results and Expansion Opportunities - In a study, patients treated with COSELA prior to Etoposide, Carboplatin, and Atezolizumab experienced a Duration of Severe Neutropenia (DSN) of 0 days compared to 4 days in the placebo group (p<0 0001) [24] - In the same study, only 1 (1 9%) of patients in the COSELA group experienced severe neutropenia compared to 26 (49 1%) in the placebo group (p<0 0001) [24] - Pooled data from three randomized placebo-controlled trials showed a 53% reduction in severe neutropenia with COSELA compared to placebo [37] - The company is aggressively pursuing development in areas of high strategic importance where COSELA is most likely to provide meaningful benefits to patients [18] Market and Launch - Approximately 30,000 ES-SCLC patients are treated annually in the U S [32] - The U S launch of COSELA in ES-SCLC occurred in 1Q 2021 [17, 18, 21, 22, 35, 36, 42, 53, 56, 62] - Internal market research indicates 77% of prescribers are either extremely or very enthusiastic to use COSELA for patients with ES-SCLC following education [34]
G1 Therapeutics(GTHX) - 2020 Q4 - Earnings Call Transcript
2021-02-25 03:41
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q4 2020 Earnings Conference Call February 24, 2021 4:30 PM ET Company Participants Will Roberts – Head-Investor Relations Jack Bailey – Chief Executive Officer Raj Malik – Chief Medical Officer Soma Gupta – Chief Commercial Officer Jen Moses – Chief Financial Officer Conference Call Participants Ed White – H.C. Wainwright Chad Messer – Needham Phil Nadeau – Cowen Tony Butler – ROTH Capital Dane Leone – Raymond James Kaveri Pohlman – BTIG David Nierengarten – Wedbush Secur ...
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2020-11-06 19:33
NASDAQ: GTHX NASDAQ: GTHX | 1 Next Generation Cancer Therapies November 2020 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 expressions referencing future events, conditions or circumstances) are intended to identify forwardlooking statements. Forward-looking statement ...
G1 Therapeutics(GTHX) - 2020 Q3 - Earnings Call Transcript
2020-11-05 02:31
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q3 2020 Results Conference Call November 4, 2020 4:30 PM ET Company Participants Jeff Macdonald - Investor Relations Mark Velleca - Chief Executive Officer Jack Bailey - Incoming CEO Soma Gupta - Chief Commercial Officer Raj Malik - Chief Medical Officer and Senior Vice President-Research and Development Jen Moses - Chief Financial Officer Conference Call Participants Anupam Rama - JPMorgan Phil Nadeau - Cowen & Co Tom Shrader - BTIG David Nierengarten - Wedbush Securitie ...