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 reported 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 for the year of $54.7 million.

2. Strategic Updates and Business Highlights

• NDA Submission: Achieve submitted a New Drug Application (NDA) for cytisinicline in June 2025, marking a shift from clinical development to commercialization.
• FDA Acceptance: The NDA was accepted by the FDA, positioning Achieve to potentially launch the first new FDA-approved smoking cessation treatment in 20 years.
• Vaping Cessation: Cytisinicline received the FDA Commissioner’s National Priority Voucher, expediting the review process for its vaping cessation indication.
• Clinical Data: Positive results from the ORCA-OL long-term exposure trial demonstrated cytisinicline's safety and tolerability, with strong patient satisfaction.
• Commercial Strategy: Achieve is building a data-driven commercial model utilizing AI for targeted outreach to physicians and patients, preparing for a launch expected in the first half of 2027.
• Manufacturing Partnership: Achieve partnered with Adare Pharma Solutions for U.S.-based manufacturing to secure supply chain reliability and reduce risks associated with international imports.

3. Forward Guidance and Outlook

• Launch Timeline: The company anticipates launching cytisinicline in the first half of 2027, contingent on receiving FDA approval by June 2026.
• Market Opportunity: Achieve aims to address the significant unmet need in nicotine dependence, with approximately 25 million smokers and 18 million vapers in the U.S.
• Commercial Readiness: The commercial team is focused on securing coverage, ensuring supply chain readiness, and increasing awareness among healthcare providers.

4. Bad News, Challenges, or Points of Concern

• GMP Observations: The manufacturer named in the NDA received two observations during an FDA inspection, which are being addressed. This has led to a strategic decision to transfer manufacturing to Adare to mitigate risks.
• Regulatory Uncertainty: While the NDA is under review, there is limited communication about the specifics of interactions with the FDA.
• Market Competition: The company faces challenges in establishing cytisinicline as a preferred treatment amidst existing smoking cessation therapies.

5. Notable Q&A Insights

• Launch Preparation: Management emphasized the importance of having drug supply ready for market and the strategic decision to ensure all processes are optimized for launch.
• Insurance Coverage: Achieve is actively engaging with payers to secure coverage, with early conversations indicating interest in cytisinicline due to its differentiated profile.
• Patient Compliance: Data from trials suggest that the dosing schedule of cytisinicline (three times daily) is manageable for patients, with high adherence rates reported.
• Supply Chain Security: Achieve has stockpiled sufficient raw material to ensure a three-year supply for anticipated market demand, addressing concerns about third-party supplier reliability.

Overall, Achieve Life Sciences is making significant strides towards launching cytisinicline, with a strong focus on regulatory progress, commercial readiness, and addressing the public health crisis of nicotine dependence. However, challenges related to manufacturing and regulatory processes remain critical areas to monitor.