ACHV — Achieve Life Sciences, Inc.

Summary of Achieve Life Sciences Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• Cash Position: As of December 31, 2025, Achieve had cash, cash equivalents, and marketable securities totaling $36.4 million.
• Operating Expenses: Total operating expenses for Q4 2025 were $14.7 million, and for the full year, they were $54.9 million.
• Net Loss: The net loss for Q4 was $14.7 million, with a total net loss of $54.7 million for the year.

2. Strategic Updates and Business Highlights

• NDA Submission: Achieve submitted a New Drug Application (NDA) for cytisinicline in June 2025, marking a shift from a clinical development focus to a commercial enterprise.
• FDA Acceptance: The NDA was accepted by the FDA, positioning Achieve to potentially be the first new FDA-approved treatment for nicotine dependence in 20 years.
• Vaping Cessation: Achieve received the FDA Commissioner’s National Priority Voucher, facilitating an expedited review process for the vaping cessation indication.
• Clinical Data: Positive results from the ORCA-OL long-term exposure trial demonstrated cytisinicline's safety and tolerability over 52 weeks. Additional data showed improved quit rates in COPD patients.
• Commercial Strategy: The company is building a scalable commercial model leveraging AI and advanced analytics to target healthcare providers and patients effectively.
• Manufacturing Partnership: Achieve partnered with Adare Pharma Solutions for U.S. manufacturing, enhancing supply chain security and reducing risks associated with international imports.

3. Forward Guidance and Outlook

• Launch Timeline: Achieve plans to launch cytisinicline in the first half of 2027, following the expected NDA approval in June 2026.
• Market Opportunity: The company emphasizes the significant unmet need for nicotine dependence treatments, with 25 million smokers and 18 million vapers in the U.S.
• Insurance Coverage: Ongoing discussions with payers are expected to facilitate broad and affordable coverage at launch, aided by the Affordable Care Act's provisions for smoking cessation treatments.

4. Bad News, Challenges, or Points of Concern

• GMP Observations: The manufacturer associated with the NDA received two observations during an FDA inspection, which are being addressed. This has led to a decision to transfer manufacturing to Adare, potentially complicating the NDA process.
• Regulatory Risks: The company is limited in its ability to discuss interactions with the FDA during the NDA review process, creating uncertainty around timelines and outcomes.
• Market Competition: There is a need to establish cytisinicline's market presence against existing smoking cessation options, which have not evolved significantly in two decades.

5. Notable Q&A Insights

• Launch Readiness: The gap between NDA approval and product launch is primarily focused on ensuring drug availability and scaling up commercial operations.
• Healthcare Provider Awareness: Awareness among healthcare providers is currently low, with plans to ramp up educational efforts closer to the launch date.
• Supply Chain Security: Achieve has stockpiled raw materials to ensure a reliable supply chain, aiming for more than three years of supply by launch.
• Dosing Schedule Concerns: High adherence rates were reported in trials, indicating that the dosing schedule of three times a day is manageable for patients.
• Pricing Strategy: While the company is aware of external pricing analyses, it has not finalized its pricing strategy and is focused on ensuring broad access and affordability.

This summary encapsulates Achieve Life Sciences' current financial standing, strategic initiatives, and outlook while addressing potential challenges and insights from the Q&A session.