Achieve Life Sciences, Inc. Q3 FY2025 earnings call

• Achieve made significant progress in NDA submission and acceptance for cytisinicline for smoking cessation, with a PDUFA date of June 20, 2026. - FDA awarded Commissioner's National Priority Voucher (CNPV) for e-cigarette/vaping indication, enabling expedited NDA review (1-2 months instead of 10-12 months). - Progress in ORCA-OL trial: submitted 120-day safety update, DSMC found no serious treatment-related adverse events, last participant completed 1-year study, and exit survey responses showed over 97% of participants believed cytisinicline helped them quit. - Data from ORCA-2 and ORCA-3 trials published in PHLX showing cytisinicline improved quit rates in COPD smokers. - AI-driven commercial strategy leveraging machine learning for next best action orchestration, omnichannel marketing, and audience activation. - Team updates: Dr. Mark Rubenstein as Interim CMO, Craig Donnelly promoted to COO, Eric Atkinson joined as CLO. - Commercial preparation for launch: selected third-party logistics provider, home state licensing application accepted in Washington State, pricing and payer research advanced, patient and HCP targeting initiatives progressed.

No detailed financial performance by product segment with absolute terms and revenue contribution % provided in the transcript.

• PDUFA date for smoking cessation NDA is June 20, 2026, with potential launch in third or fourth quarter 2026. - Acceleration of product launch for vaping indication due to CNPV, potentially reducing approval time to 1-2 months. - Current cash runway funds operations into second half of 2026, but additional funding needed for vaping study. - Focus on executing NDA approval, data-driven commercial platform, and progress on vaping indication.

No specific risks detailed in the transcript, but potential risks could include regulatory delays, market competition, and funding challenges for vaping study.

Q: Jamie mentioned a specialty distributor. Is there a complementary retail strategy?

A: Yes, there is a complementary retail strategy in place, with specialty route being optimal initially.

Q: Cash runway into second half of next year - does it contemplate funding vaping study?

A: No, separate funding needed for vaping study.

Q: Protocol for vaping Phase III trial?

A: Similar to smoking cessation trials, 12-week trial of cytisinicline vs placebo with behavioral treatment, follow-up at 12 and 24 weeks, using blood/saliva analysis to confirm nicotine exposure.

Q: Benefits of cytisinicline in COPD patients?

A: Quit rates in COPD smokers on cytisinicline comparable to those without COPD, with placebo group having very low quit rates.

Q: Impact of CHANTIX reintroduction on smoking cessation market?

A: Cytisinicline has superior side effect profile (5x less nausea/vomiting than varenicline) and is seen as a superior product despite CHANTIX reintroduction.

Q: Commercial infrastructure overlap between smoking and vaping?

A: Targeting different patient populations (older smokers vs younger vapers), but similar physician targeting, with younger vapers more digitally inclined.