By John Vandermosten, CFA
NASDAQ: ACHV
READ THE FULL ACHV RESEARCH REPORT
Achieve Life Sciences, Inc. (NASDAQ: ACHV) reported 2025 results following the submission of a new drug application (NDA) to the FDA and the assignment of cytisinicline’s Prescription Drug User Fee Act (PDUFA) date of June 20th, 2026. While the FDA reviews the application, Achieve has been hard at work on pre-commercialization activities working with Omnicom to support the commercial launch of cytisinicline. Since the company’s previous quarterly update in November, Dr. Mark Rubinstein has been promoted to Chief Medical Officer, management held meetings during the JP Morgan Healthcare conference in January and team members presented data from the pivotal and safety trials at the Society for Research on Nicotine & Tobacco (SRNT) 2026 Annual Meeting. In its earnings release Achieve announced that it will be working with the domestic manufacturer Adare Pharma to provide cytisinicline drug product to support an anticipated 1H:27 product launch.
Financial and Operational Results
Achieve’s 2025 financial and operational results were detailed in a press release, Form 10-K filing and a webcast which provided analysts the opportunity to ask questions. No revenues were reported in 2025. Operating expense was $54.9 million producing a net loss of ($54.7) million or ($1.25) per share. For the year ending December 31st, 2025 versus the prior year:
- Research & development expense totaled $23.0 million, up 1% from $22.8 million, due to higher employee costs from increased headcount and higher manufacturing and supply chain costs associated with commercial launch preparation, including purchase of raw cytisinicline inventory expenses prior to regulatory approval. This was partially offset by lower clinical trial costs associated with the wind down of the ORCA-OL trial, which was completed last year;
- General & administrative expense was $31.9 million, up 96% from $16.3 million on higher employee expenses and commercial launch preparation;
- Net interest income was $0.7 million vs. $0.2 million as interest income offset interest expense on higher cash balances;
- Other expense of $0.4 million compares to $0.9 million. The amount is related to change in fair value of contingent consideration and other expense;
- Net loss was $54.7 million vs. $39.8 million or $1.25 and $1.24 per share, respectively.
As of December 31st, 2025, cash and equivalents totaled $36.4 million. This compares to a $34.4 million balance held at the end of 2024. At year end, Achieve carried convertible debt of $14.9 million on the balance sheet which includes an additional $5 million drawn down in October 2025 upon achieving its milestone of NDA acceptance. Cash used in operations during 2025 was $49.5 million versus $29.8 million in the same prior year period.
SRNT Presentation
Achieve presented new data at the Society for Research on Nicotine & Tobacco (SRNT) 2026 Annual Meeting, held from March 4-7 in Baltimore, Maryland. Information was presented at two sessions drawing from participants in the ORCA-OL and the more than 1,600 participants in the ORCA-2 and ORCA-3 studies. Titles of the sessions and conclusions are included below.
- Cytisinicline in Adult Smokers: Post-Trial Survey from ORCA-OL
- Many individuals do not complete a smoking cessation course of therapy due to side effects and patient experience is important to success
- Participants reported better physical health while taking cytisinicline including improved breathing, increased stamina and greater vitality
- Participants were satisfied with cytisinicline reporting that the urge to smoke had lessened, and fewer psychological cravings
- Cytisinicline was well tolerated even with up to one year of use with no new safety signals during the open label phase
- Efficacy of Cytisinicline for Smoking Cessation in Adults with and without Multiple Prior Quit Attempts or Prior Pharmacotherapy Use: Pooled Analysis of Two Phase 3 Trials
- The presentation concluded that cytisinicline was effective and well-tolerated regardless of participants’ prior use of smoking cessation medications or number of previous quit attempts
- If approved in the US, cytisinicline will offer a new quit option for patients, including those who have failed other medications
- Cytisinicline was consistent across regimens with benefits observed for both the six- and twelve-week treatment courses, although the twelve-week course provided improved long-term outcomes
Manufacturer Relationships
Achieve raised concerns in its third quarter 10-Q filing regarding Sopharma’s ability to pass an FDA pre-approval inspection and has engaged other third-party manufacturers to produce tableted and packaged cytisinicline. In response, Sopharma has alleged that engagement of third-party manufacturers is a breach of the Sopharma License and Supply Agreement. The two parties are discussing a resolution.
Achieve is sourcing its cytisinicline from a supplier in China who is extracting cytisine from the Thermopsis tree. If Achieve is not able to come to an agreement with Sopharma, it plans to source cytisinicline from China, formulate, tablet and package it at partners in India and France, and then have it shipped to the United States for commercialization. Additionally, the company has also disclosed that it has intellectual property rights pending for synthetic cytisinicline. This may play a role in the future and could provide further sourcing flexibility and efficiency.
Due to observations by the FDA related to solid oral dose manufacturing with the manufacturer listed in the NDA and a desire to move production to the United States, Achieve announced that it had partnered with Adare Pharma Solutions to manufacture cytisinicline drug product for potential commercial launch. Achieve and Adare have begun a technology transfer following three development agreements that the two entities have signed with each other. We see multiple sources of cytisinicline manufacturing, especially one in the United States as a material positive for the company which provides flexibility and the ability to sidestep any future tariffs that may exist.
Summary
Achieve management confirmed the June 20th PDUFA date; however, issues at the company’s manufacturers have raised the risk of a potential delay, especially if the questions cannot be resolved sufficiently prior to the anticipated approval date. The status and disposition of the observations is between the manufacturer and the FDA, which gives Achieve limited visibility on the process. In an effort to execute a stronger launch, management has pushed back its anticipated launch of cytisinicline to 1H:27 which will allow sufficient supply to be available and give more time to contract with payors. The marketing team continues its efforts with Omnicom to communicate with stakeholders and implement its digital campaign.
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