Achieve Life Sciences | 10-Q: FY2025 Q3 Revenue: USD 0

Revenue: As of FY2025 Q3, the actual value is USD 0.

EPS: As of FY2025 Q3, the actual value is USD -0.28, missing the estimate of USD -0.2571.

EBIT: As of FY2025 Q3, the actual value is USD -15.05 M.

Operational Metrics

• Net Loss: Achieve Life Sciences, Inc. reported a net loss of $40.0 million for the nine months ended September 30, 2025, compared to a net loss of $27.5 million for the same period in 2024.
• Research and Development Expenses: R&D expenses increased to $19.1 million for the nine months ended September 30, 2025, from $15.5 million for the same period in 2024, primarily due to costs associated with the ORCA-OL trial.
• General and Administrative Expenses: These expenses increased to $21.0 million for the nine months ended September 30, 2025, from $11.4 million for the same period in 2024, primarily due to higher commercial launch preparation and employee costs.

Cash Flow

• Net Cash Used in Operating Activities: For the nine months ended September 30, 2025, net cash used in operating activities was $31.5 million, compared to $20.6 million for the same period in 2024.
• Net Cash Provided by Financing Activities: Achieve Life Sciences, Inc. reported net cash provided by financing activities of $45.3 million for the nine months ended September 30, 2025, compared to $47.8 million for the same period in 2024.
• Net Cash Provided by Investing Activities: For the nine months ended September 30, 2025, net cash provided by investing activities was $5.4 million, compared to $33.3 million used in investing activities for the same period in 2024.

Future Outlook and Strategy

Core Business Focus

• Regulatory Progress: The FDA accepted the NDA for cytisinicline as a treatment for smoking cessation, with a PDUFA targeted action date of June 20, 2026. The company plans to commence commercial sales of cytisinicline in the United States in the second half of 2026, focusing on highly targeted prescriber and patient audiences.

Non-Core Business

• Vaping Cessation: Achieve Life Sciences, Inc. received Breakthrough Therapy designation from the FDA for cytisinicline for nicotine e-cigarette cessation and was awarded the Commissioner’s National Priority Voucher (CNPV) as part of the pilot program.