• Cash Equivalents and Marketable Securities: $34.4 million as of December 31, 2024, up from $15.6 million on December 31, 2023.
• Operating Expenses: $12.2 million for Q4 2024 and $39.1 million for the year ended December 31, 2024.
• Net Loss: $12.4 million for Q4 2024 and $39.8 million for the year ended December 31, 2024.
• Cash Runway: Sufficient to provide runway into the third quarter of 2025.

• Warning! GuruFocus has detected 2 Warning Sign with ACHV.

Release Date: March 11, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Achieve Life Sciences Inc (NASDAQ:ACHV) plans to submit the NDA for Cytisinicline as a treatment for nicotine dependence by the end of the next quarter.
• Cytisinicline has received breakthrough therapy designation for vaping cessation, highlighting its potential impact.
• The company completed enrollment in the ORCA Open label long-term safety exposure clinical trial, meeting FDA requirements for NDA submission.
• Achieve Life Sciences Inc (NASDAQ:ACHV) has strengthened its leadership team with new appointments, enhancing its corporate strategy and commercialization efforts.
• The company has a robust commercialization plan in place, focusing on awareness, access, and availability to ensure a successful market entry.

Negative Points

• Achieve Life Sciences Inc (NASDAQ:ACHV) reported a net loss of $12.4 million for the fourth quarter and $39.8 million for the year ended December 31, 2024.
• The company's cash balance is projected to provide runway only into the third quarter of 2025, indicating potential financial constraints.
• There is uncertainty regarding the potential barriers for generics entering the market, which could impact long-term exclusivity.
• The anticipated slow ramp-up in sales post-launch due to the time required for gaining access and awareness could affect initial revenue generation.
• The company is dependent on securing additional financing to initiate the Phase 3 ORCA-V2 clinical trials for vaping cessation.

Q & A Highlights

Q: Can you clarify what still needs to be done before the NDA submission for smoking cessation, and are there any specific FDA requirements from a manufacturing standpoint? A: Richard Stewart, CEO, emphasized the focus on executing a high-quality NDA submission. Cindy Jacobs, President and CMO, mentioned that they are finalizing summary documents for efficacy and safety, with CMC sections nearly complete. They have engaged external experts to ensure accuracy and quality.

Q: Regarding commercial access for cytisinicline, do you expect any prior authorization or step edits for generics, and will you use a specialty pharmacy to ensure patients get their full treatment? A: Jaime Xinos, Chief Commercial Officer, stated they are considering a "specialty light" pharmacy to track prescriptions and mitigate access barriers. The strategy will depend on contracting and payer formulary placement, with plans to address potential barriers through medical exceptions and patient refusal to use other medications.

Q: Are you getting closer to a potential partner for a comorbid indication with cytisinicline, and could this help accelerate the start of the vaping Phase 3 trial? A: Richard Stewart, CEO, noted that while there is interest in cytisinicline's impact on COPD patients, the current focus is on the NDA submission. They are open to partnerships that align with shareholder interests but are primarily focused on launching cytisinicline themselves.

Q: Are there future DSMC reviews planned, and how are the mock reviews with Sopharma going? A: Cindy Jacobs, President and CMO, mentioned one more DSMC review is likely for the long-term safety data. Richard Stewart, CEO, assured that they are using external consultants to ensure the NDA's quality, including manufacturing aspects with Sopharma.

Q: Can you provide more details on the sales ramp and segmentation strategy for the launch in Q3 2026? A: Jaime Xinos, Chief Commercial Officer, indicated a slow initial ramp due to access and awareness building. They are targeting high-volume prescribers and highly motivated quitters, focusing on those most likely to adopt the product.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.