Achieve Life Sciences (ACHV) Barclays 27th Annual Global Healthcare Conference 2025 summary

Key announcements and milestones

• NDA for cytisinicline as a treatment for nicotine dependence is on track for filing next quarter, with anticipated launch in Q3–Q4 2026 for smoking cessation and 2027–2028 for vaping cessation.

• Cytisinicline has received FDA Breakthrough designation and priority review, with a well-defined regulatory and launch pathway.

• Two successful Phase III trials in smoking cessation and a Phase II trial in vaping demonstrated robust efficacy and a favorable side effect profile.

• The company has completed required safety studies for NDA submission, including 300 patients with six months' exposure.

• Management team has extensive experience in pharma and successful product launches.

Market opportunity and strategy

• U.S. market includes 29 million smokers and 11 million vapers, with high unmet need and significant health and economic impact.

• Smoking-related diseases cost over $300 billion annually, with 80% of COPD and lung cancer deaths linked to smoking.

• Initial launch will target 7,000 high-prescribing physicians, focusing on those who previously prescribed varenicline.

• Affordable Care Act mandates coverage for smoking cessation, supporting access and reimbursement.

• Omnichannel, data-driven marketing approach will be used to reach both physicians and motivated quitters.

Product differentiation and clinical data

• Cytisinicline offers superior efficacy to Chantix (odds ratio 5.3–5.8 vs. 2.3) and a more benign side effect profile (6.2% nausea/vomiting vs. 30%).

• Flexible dosing (6 or 12 weeks) and robust response in both regimens, with significant p-values in clinical trials.

• Vaping cessation Phase II showed positive results; Phase III to enroll 800 patients, aiming for launch in 2027–2028.

• No branded competition; generic Chantix still sees 1.3 million scripts annually.

• Strong IP portfolio with regulatory exclusivity of about 7.5 years.