Achieve Life Sciences, Inc. Q4 FY2025 earnings call

Greetings and welcome to the Achieve Life Sciences earnings call. The management team discussed the transformation of Achieve from a pure play clinical development company to a commercially focused enterprise. Key highlights in 2025 include submission of NDA for smoking cessation indication and its acceptance by FDA, receiving commissioner's national priority voucher for vaping cessation indication, clinical team delivering on regulatory milestones and generating encouraging data, post hoc data in Thorax showing cytosinicline improved smoking quit rates in COPD patients, commercial team building a scalable digital platform, selecting Adair Pharma Solutions for manufacturing, launching Willpower Awareness Campaign, and Dr. Mark Rubenstein detailing regulatory progress and clinical data, Jamie Zenos discussing commercial priorities like availability, access, awareness, and Mark Oakey providing financial updates.

Anticipates launch of cytosinicline for smoking cessation in first half of 2027, growing recognition of opportunity with vaping indication, underpinned by digital commercial platform. PDUFA date for NDA remains June 25, 2026. Ongoing discussions with payers regarding coverage, and progress with FDA on vaping indication including site selection.

Uncertainties related to FDA review process, including observations during GMP inspection of manufacturer in NDA, geopolitical factors affecting supply chain, potential delays in regulatory approval, and uncertainties around payer coverage and commercial uptake.

Q: About launch timing between June NDA approval and first half 2027 launch, critical path including commercial scale up and product supply.

A: Need drugs in supply chain first, 3PL, specialty pharmacy hub etc. ready, additional time to get data and partnerships.

Q: On manufacturing observations and implications for NDA.

A: PDUFA date remains June 25, accelerated transfer to US manufacturing for contingency.

Q: Healthcare provider awareness and FDA dialogue on vaping.

A: Pre-approval conserving resources, will ramp up closer to launch; FDA discussions around vaping protocol, site selection.

Q: US commercial launch timeline and manufacturing.

A: 1H2027 launch assumes June 2026 approval, post-approval for DARE, ongoing discussions with payers.

Q: Raw plant material supply chain and dosing schedule.

A: Stockpiling starting material, more than three years' supply; dosing schedule well-tolerated with high adherence rates.

Q: ICER report, manufacturing entities.

A: Seen ICER report, not commenting on pricing; pieces of manufacturing jigsaw with different entities and progress.