Summary of Achieve Life Sciences Q4 2025 Earnings Call

1Key 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.

2Strategic 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.

3Forward 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.

4Bad 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.

5Notable 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.