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Better Therapeutics(BTTX) - 2023 Q2 - Earnings Call Presentation
2023-08-10 14:40
AUGUST 09, 2023 THERAPEUTICS Better Therapeutics Team Frank Karbe Diane Gomez-Thinnes Chief Commercial Officer Disclaimer Certain statements in this Presentation may be considered forward-looking statements, within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," " ...
Better Therapeutics(BTTX) - 2023 Q2 - Earnings Call Transcript
2023-08-10 02:34
Financial Data and Key Metrics Changes - The net loss for Q2 2023 was $7.6 million, an improvement from $9.9 million in Q2 2022, resulting in a loss per share of $0.24 compared to $0.41 last year [16][17] - Cash and cash equivalents decreased to $6.2 million as of June 30, 2023, down from $15.7 million at the end of 2022, but pro forma cash after recent financings was $12.9 million [40][128] - Operating expenses were reduced significantly, with R&D expenses at $2.2 million compared to $4.2 million in the same period last year [37] Business Line Data and Key Metrics Changes - AspyreRx is positioned to treat the majority of the 29 million adults diagnosed with Type 2 diabetes in the U.S. [5] - The company is focusing on a cash pay option for patients with insurance claim rejections, aiming to keep out-of-pocket costs low [4] Market Data and Key Metrics Changes - Over 72% of payers find AspyreRx valuable, with 64% anticipating coverage, indicating strong market interest [2] - The company is targeting five to six priority geographies for initial market penetration based on data analysis [118] Company Strategy and Development Direction - The company aims to commercialize AspyreRx in Q4 2023, with plans to broaden payer coverage and secure federal supply schedule access [21][128] - The strategy includes obtaining breakthrough device designation for NAFLD and NASH by the end of 2023 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving commercial traction through provider, payer, and patient adoption of AspyreRx [18] - The FDA authorization has resolved regulatory risks and is expected to facilitate broader payer discussions [18][59] Other Important Information - The wholesale acquisition cost for AspyreRx is set at $750 for a 90-day treatment, with a total expected cost of $1,500 for a six-month treatment [112][113] - The company has completed approximately 90% enrollment in its real-world evidence studies, on track for completion by the end of Q3 2023 [108] Q&A Session Summary Question: What will operating expenses look like post-commercialization? - Management indicated that operating expenses are expected to remain flat initially, with potential increases depending on commercial traction [70] Question: How many patients will be enrolled in the real-world evidence study? - Approximately 1,000 patients are expected to be enrolled, with interim data anticipated by the end of the year [51] Question: What is the expected cash pay price for AspyreRx? - The cash pay price is not finalized, but providers suggest a reasonable range of $25 to $50 per month for out-of-pocket costs [53][75] Question: How are early discussions with payers going post-authorization? - Management reported encouraging feedback from payers regarding the trial design and clinical data, with ongoing discussions about value-based agreements [82][84]
Better Therapeutics(BTTX) - 2023 Q2 - Quarterly Report
2023-08-09 20:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 | --- | --- | |-------------------------------------------------------------------------------|------------------------------------------| | | | | Commission File Number: | 001-39864 | | BETTER THERAPEUTICS, INC. | | | Delaware | 85-3472546 | | ( State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | | 548 Market St. #49404 | | | San Francisco, CA (Address of principal executive offices) | 9 ...
Better Therapeutics(BTTX) - 2023 Q1 - Earnings Call Transcript
2023-05-14 08:13
And finally, a decrease in HbA1C and outpatient visits were cited most in terms of measures for a successful diabetes treatment. We look forward to taking these valuable insights as we move into meetings with key supporters at the national level while developing our VISN-level coverage approach. As we refine our plans for market entry, the first phase in our launch will be focused on continuing efforts to expand coverage amongst payers. Covered lives will be a key metric and determinant of success for us. W ...
Better Therapeutics(BTTX) - 2023 Q1 - Quarterly Report
2023-05-11 11:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 For the transition period from ____________ to ______________ Page Item 1. Legal Proceedings 26 Item 1A. Risk Factors 26 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 67 Item 3. Defaults Upon Senior Securities 68 Item 4. Mine Safety Disclosures 68 Item 5. Other Information 68 Item 6. Exhibits 69 Signatures 70 | --- | --- | |-------|-------------------------------------------------------------------------------------- ...
Better Therapeutics(BTTX) - 2022 Q4 - Earnings Call Transcript
2023-03-30 18:42
Company Participants Conference Call Participants Operator I would now like to turn the call over to Mark Heinen, Chief Financial Officer. Please begin. Thank you, operator. Good morning, everyone, and welcome to the Better Therapeutics Conference Call. Our press release was issued this morning and can be found in the Investors section of corporate website bettertx.com. During today's call, we will provide a business update a financial overview of the fourth quarter and fiscal year 2022 and provide our outl ...
Better Therapeutics(BTTX) - 2022 Q4 - Annual Report
2023-03-30 11:42
Coverage and Reimbursement 31 To optimize payer reimbursement coverage following a potential commercial launch, we are generating evidence to substantiate the value of BT-001 with longer-term data related to usage and outcomes in a real world setting. This is additive to the evidence generated from our six-month randomized controlled pivotal trial. We are conducting such real world evidence studies in partnerships with Mass General Brigham, Colorado Prevention Center Clinical Research, University of Colorad ...
Better Therapeutics(BTTX) - 2022 Q3 - Earnings Call Transcript
2022-11-15 03:27
Better Therapeutics, Inc. (OTC:BTTX) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Mark Heinen - Chief Financial Officer Frank Karbe - President and Chief Executive Officer Mark Berman - Chief Medical Officer Diane Gómez-Thinnes - Chief Commercial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets Rahul Rakhit - LifeSci Capital Keay Nakae - Chardan Operator Good afternoon, and welcome to the Better Therapeutics Third Quarter 2022 Financial R ...
Better Therapeutics(BTTX) - 2022 Q3 - Earnings Call Presentation
2022-11-15 03:26
n | www.bookmark.com/art/an/and/au/mat/multion/arma Pioneering Prescription Digital Therapeutics for Cardiometabolic Diseases THIRD QUARTER 2022 EARNINGS CONFERENCE CALL NOVEMBER 14, 2022 THERAPEUTICS Disclaimer This presentation ("Presentation") is for informational purposes only. The information contained herein does not purport to be all-inclusive and neither Better Therapeutics, Inc. ("BetterTX" or the "Company") nor any of its respective affiliates nor any of its or their control persons, officers, dir ...
Better Therapeutics(BTTX) - 2022 Q3 - Quarterly Report
2022-11-14 22:25
Company Overview - Better Therapeutics, Inc. is focused on developing prescription digital therapeutics to address cardiometabolic diseases, with the U.S. spending approximately $4.0 trillion annually on healthcare, 90% of which is for chronic diseases[88]. Clinical Trials and Product Development - The clinical trial for BT-001 involved 668 patients with type 2 diabetes, achieving a statistically significant A1c reduction of -0.4% at 90 days (p < 0.001) and -0.3% at 180 days (p <= 0.01) compared to the control group[91]. - The mean A1c reduction for BT-001 patients was 1.3%, with half of the patients achieving clinically meaningful improvements[91]. - The FDA accepted the de novo classification request for BT-001 in October 2022, which could lead to marketing authorization for treating type 2 diabetes[91]. - The company initiated real-world evidence studies to evaluate the long-term effectiveness of BT-001, with interim results expected in 2023[93]. - A clinical study for digitally delivered CBT to reduce liver fat and improve liver disease biomarkers is underway, with 22 patients enrolled[94]. Financial Performance - Research and development expenses for Q3 2022 were $5.5 million, down from $6.7 million in Q3 2021, primarily due to decreased clinical trial costs[111]. - Total operating expenses for Q3 2022 were $10.996 million, a 22% increase from $8.995 million in Q3 2021[110]. - The net loss for Q3 2022 was $11.405 million, an 8% decrease from $12.461 million in Q3 2021[110]. - Research and development expenses increased to $13.4 million for the nine months ended September 30, 2022, compared to $13.1 million for the same period in 2021, primarily due to a $4.9 million rise in personnel and consulting costs[112]. - Sales and marketing expenses rose to $5.3 million for the nine months ended September 30, 2022, from $1.2 million in the same period of 2021, driven by increased personnel, marketing, and consulting expenses for BT-001's potential launch[114]. - General and administrative expenses were $11.3 million for the nine months ended September 30, 2022, compared to $4.2 million for the same period in 2021, largely due to a $3.4 million increase in personnel and consulting costs[116]. - Interest expense, net was $1.1 million for the nine months ended September 30, 2022, compared to $3,000 for the same period in 2021, reflecting interest on a secured term loan with Hercules Capital[119]. - The company reported a net cash used in operating activities of $22.6 million for the nine months ended September 30, 2022, compared to $15.0 million for the same period in 2021[129]. - Cash provided by financing activities was $5.2 million for the nine months ended September 30, 2022, down from $18.7 million in the same period of 2021, primarily due to proceeds from long-term debt and stock options[132]. - As of September 30, 2022, the company had $22.3 million in cash and an accumulated deficit of $102.7 million, indicating significant cash burn and reliance on external funding[125]. - The company expects to incur substantial expenses for the development and potential commercialization of its product candidates, indicating a need for additional funding in the future[127]. Funding and Capital Structure - The company completed a merger with Mountain Crest Acquisition Corp. II, raising $59.0 million in funding upon completion[123]. - The secured term loan agreement with Hercules Capital allows for borrowing in tranches based on clinical milestones, with $10.0 million borrowed in October 2021 and $5.0 million in May 2022[124]. Accounting and Reporting - No impairment of long-lived assets was indicated during the nine months ended September 30, 2022[145]. - Equity-based compensation expense is recognized over the service period, with performance conditions only recognized if probable[146]. - The fair value of common stock is determined based on the closing price on the grant date[149]. - The expected term for equity-based awards is calculated using the simplified method, averaging the time-to-vesting and contractual life[150]. - Expected volatility for options was estimated using the average historic price volatility of industry peers due to limited trading history[151]. - The company is classified as an "emerging growth company" and intends to take advantage of certain exemptions from reporting requirements[159]. - The company will remain an emerging growth company until it meets specific revenue or market value thresholds[160]. - The company is also classified as a "smaller reporting company," allowing for reduced disclosure obligations[163]. - Deferred tax assets are assessed for recoverability based on future taxable income, with a valuation allowance established when necessary[156]. - Basic and diluted net loss per share attributable to common stock is equal due to all potentially dilutive securities being antidilutive[158].