Achieve Life Sciences(ACHV) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Achieve Life Sciences closed the second quarter with a strengthened balance sheet following a successful $45 million public offering in June, which included common stock and warrants [29] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $55.4 million, expected to support operations into 2026 [29] - Total operating expenses for the three and six months ended June 30, 2025, were $12.6 million and $25.5 million respectively, consistent with expectations as the company increased investment in regulatory and pre-commercial planning [30] - The net loss for the same periods was $12.7 million and $25.5 million respectively [30] Business Line Data and Key Metrics Changes - The company achieved three transformative milestones: the submission of a new drug application (NDA) for cytisinicline, a strategic partnership with Omnicom, and a capital raise of $49 million [5][6] - The NDA submission is supported by data from over 2,000 clinical trial participants, including results from two Phase III studies and long-term safety data [12][13] Market Data and Key Metrics Changes - There are approximately 29 million smokers in the U.S., with over 15 million attempting to quit each year, highlighting a significant market opportunity for cytisinicline [7] - The annual cost of smoking-related health issues in the U.S. is over $600 billion, indicating a substantial public health burden [8] Company Strategy and Development Direction - The company aims to change the narrative around nicotine dependence, positioning it as a medical condition that requires effective treatment options [7][24] - Achieve is focused on a data-driven approach to its commercial launch strategy, leveraging a proprietary AI-enabled platform for decision-making and performance optimization [19][26] - The strategic partnership with Omnicom is intended to enhance brand development, market access, and stakeholder engagement ahead of the product launch [18][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory process and anticipates receiving the FDA's Day 74 NDA acceptance letter in mid-September [31] - The company is committed to executing its strategy with financial prudence while preparing for a potential product launch in late 2026 [31][32] - Management highlighted the importance of building relationships with payers to ensure rapid access to cytisinicline following approval [22][23] Other Important Information - The company plans to complete the ORCA-OL study database by the end of the year and aims to present the results in 2026 [15][68] - Achieve is actively engaging with the FDA and has requested a priority review for the NDA submission, although a standard review is currently anticipated [50] Q&A Session Summary Question: Will the 120-day safety update include only 100 patients or the full 290? - The company will submit all subjects available at the time of the database cut, which will be more than 100 but not the full 290 [34] Question: How will commercial spending ramp up ahead of launch? - The company will incrementally increase pre-commercial activities prior to approval, with a disciplined approach to commercial investment [35][36] Question: Will cytisinicline be priced at a premium compared to generic options? - The company views cytisinicline as a branded product at a premium price, supported by its differentiated profile [37] Question: What initial contact methods will be used to reach providers? - The company plans to identify individual needs of targeted physicians and engage through various channels, including social media and email [40][42] Question: What is the overall safety profile of cytisinicline? - The safety profile remains consistent with previous data, with no new safety signals identified [46][47] Question: Will there be any updates on future clinical development before the end of the year? - The company plans to complete the ORCA-OL study database quickly and aims to present data at conferences in 2026 [66][68]