Achieve Life Sciences reports Q2 EPS of 37c, beats consensus of 35c.

Achieve Life Sciences reported Q2 EPS of 37 cents, beating consensus of 35 cents. The company reached a major milestone by submitting its NDA for cytisinicline, securing a commercialization partnership with Omnicom, and securing financing. Cytisinicline, if approved, would be the first new pharmacotherapy option for nicotine dependence in nearly two decades.

Achieve Life Sciences (NASDAQ: ACHV) announced its Q2 2025 financial results on Thursday, August 7, before market open. The company reported an EPS of 37 cents, surpassing the consensus estimate of 35 cents. This marks a significant achievement for the biopharmaceutical company, which has been making steady progress in its efforts to commercialize cytisinicline, a potential game-changer in smoking cessation treatment.

One of the key highlights of the quarter was the submission of a New Drug Application (NDA) to the FDA for cytisinicline. This submission represents a major milestone in Achieve Life Sciences' decade-long research and development journey. The NDA is supported by positive efficacy data from the Phase 3 ORCA-2 and ORCA-3 trials, which demonstrated significantly higher quit rates compared to placebo [2].

The company also secured a strategic partnership with Omnicom for commercialization. This collaboration brings together seven specialized agencies operating as a single, unified team across various functions, including brand development, medical and patient education, market access, public relations, media, and marketing technology. This partnership aims to reduce commercial buildout costs while maximizing launch effectiveness, a critical consideration for small biotechs transitioning to commercialization [2].

From a financial perspective, Achieve Life Sciences raised $49.3 million through a public offering, strengthening its position and extending its runway into the second half of 2026. As of June 30, 2025, the company had $55.4 million in cash and equivalents, with a net loss of $12.7 million for Q2 2025 [2].

The successful completion of the FDA long-term exposure requirements in the ORCA-OL trial and the publication of the ORCA-3 results in JAMA Internal Medicine further validate cytisinicline's clinical profile and provide third-party scientific credibility. These achievements are particularly notable given the substantial unmet medical need in the smoking cessation market, where innovation has been stagnant for two decades [2].

Achieve Life Sciences' stock fell after the announcement of the NDA submission, but the company's progress and strategic partnerships position it well for potential commercialization. The company is committed to working closely with the FDA to advance cytisinicline, which, if approved, would be the first new pharmacotherapy option for nicotine dependence in nearly two decades.

References
[1] https://seekingalpha.com/news/4480052-achieve-life-sciences-q2-2025-earnings-preview
[2] https://www.stocktitan.net/news/ACHV/achieve-life-sciences-reports-second-quarter-2025-financial-results-tw8bjhgnktub.html