Achieve Life Sciences (ACHV) Q4 2025 earnings summary

Executive summary

• Transitioned from a clinical-stage to a commercially focused company following NDA submission for cytisinicline in June 2025, with FDA acceptance and a PDUFA date of June 20, 2026.

• Achieved NDA acceptance for smoking cessation and received a Commissioner's National Priority Voucher for vaping cessation, positioning cytisinicline as a potential first-in-class treatment and expediting FDA review.

• Advanced commercial infrastructure, including digital and AI-driven platforms, and established U.S.-based manufacturing with Adare Pharma Solutions to secure supply chain and reduce international risks.

• Completed ORCA-OL long-term exposure trial, confirming cytisinicline's safety, high patient satisfaction, and exceeding FDA requirements.

• Maintained focus on addressing the unmet medical need for nicotine dependence treatments, with a Willpower awareness campaign launched to reframe public perception.

Financial highlights

• Cash equivalents and marketable securities totaled $36.4 million as of December 31, 2025.

• Operating expenses were $14.7 million for Q4 and $54.9 million for the full year 2025.

• Net loss was $14.7 million for Q4 and $54.7 million for the full year 2025.

• Basic and diluted net loss per share was $0.28 for Q4 2025 and $1.25 for the full year 2025.

Outlook and guidance

• Targeting commercial launch of cytisinicline in the first half of 2027, contingent on NDA approval expected by June 2026.

• Ongoing preparations for supply chain readiness, payer engagement, and awareness campaigns to ensure successful launch, including logistics and specialty pharmacy partnerships.

• Ongoing communication with FDA regarding manufacturing observations; remedial actions are being implemented.

• Anticipates a slow ramp in insurance coverage post-launch, with Affordable Care Act requirements supporting access.