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Achieve Life Sciences is like a focused Vertex Pharmaceuticals, but with the sole mission of developing a novel drug for nicotine cessation.

Alternatively, think of it as a Moderna, but entirely dedicated to developing a next-generation drug for smoking and vaping cessation.

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• Cytisinicline (for smoking cessation): A drug candidate currently in Phase 3 clinical trials for adults seeking to quit smoking.
• Cytisinicline (for e-cigarette cessation): A drug candidate currently in Phase 2 clinical trials for adults who use e-cigarettes and wish to quit vaping.

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Achieve Life Sciences (symbol: ACHV) is a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine e-cigarette (vaping) cessation. As of the current date, its lead product, cytisinicline, has not yet received marketing approval from regulatory authorities (such as the FDA in the U.S.) for commercial sale in major markets.

Consequently, Achieve Life Sciences does not currently have major commercial customers in the traditional sense, as it is not actively selling its product on a widespread commercial basis. The company explicitly states in its financial filings that it has not generated any revenue from the commercial sale of any product and does not expect to do so until cytisinicline is successfully developed, approved, and commercialized.

However, once cytisinicline receives regulatory approval and is launched commercially, Achieve Life Sciences would primarily sell its product to other companies within the healthcare supply chain, operating on a business-to-business (B2B) model. Its anticipated major customers would include:

1. Pharmaceutical Distributors: These companies purchase pharmaceuticals in bulk from manufacturers and then distribute them to pharmacies, hospitals, and other healthcare providers across the country. Examples of major public distributors include:

   • AmerisourceBergen (ABC)
   • Cardinal Health (CAH)
   • McKesson Corporation (MCK)

2. Retail Pharmacy Chains and Independent Pharmacies: These entities dispense prescription medications directly to patients. Major chains would be direct or indirect customers (via distributors). Examples of major public pharmacy chains include:

   • CVS Health (CVS)
   • Walgreens Boots Alliance (WBA)

3. Hospitals and Integrated Healthcare Systems: Large hospital networks and healthcare systems purchase pharmaceuticals for inpatient use, emergency departments, and their own outpatient pharmacies. While specific hospital systems are often not publicly traded as a single purchasing entity, they represent a significant B2B customer segment for pharmaceutical companies.

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• Catalent, Inc. (CTLT)
• CordenPharma

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Richard Stewart, Chief Executive Officer

Mr. Stewart is a co-founder and the Chief Executive Officer of Achieve Life Sciences, and also serves as a director on its Board of Directors, having previously held the position of Chairman. He is also a founder and director of Ricanto Limited, a pharmaceutical asset optimization company, since 2009. Since 2016, he has been Chairman and Chief Executive Officer of Renown Pharma Limited, a central nervous system company. Prior to Achieve, Mr. Stewart was Chairman and CEO of Huxley Pharmaceuticals, Inc. in 2009, which was subsequently acquired by BioMarin Pharmaceutical Inc. He also served as CEO of Brabant Pharma Limited from 2013 to 2014, before its acquisition by Zogenix Inc. Mr. Stewart co-founded and served as Chief Executive Officer of Amarin Corporation plc from 2000 to 2007, and was a co-founder, Chief Financial Officer, and later Chief Business Officer, of SkyePharma plc from 1995 to 1998. He holds a Bachelor of Science degree in Business Administration from the University of Bath.

Mark Oki, Chief Financial Officer

Mr. Oki joined Achieve Life Sciences as Chief Financial Officer in December 2024. From January 2022 to November 2024, he was the Chief Financial Officer of Aytu Biopharma, Inc. His career also includes a tenure as CFO of Vivus LLC and senior financial positions at Alexza Pharmaceuticals, Inc., Pharmacyclics, Inc., and Incyte Genomics, Inc. Mr. Oki is a Certified Public Accountant and holds a degree in Business Administration – Accounting from San Jose State University.

Craig Donnelly, Chief Operations Officer

Mr. Donnelly was promoted to Chief Operations Officer at Achieve Life Sciences in September 2025, having joined the company in 2022 as Executive Vice President of Chemistry, Manufacturing, and Controls (CMC) and Regulatory CMC. He brings over 25 years of biopharmaceutical expertise in technical development and regulatory CMC. Previously, he held senior roles in CMC and regulatory functions at companies such as NuCana, ICON (formerly Mapi), and F. Hoffman-La Roche. Mr. Donnelly began his career as an analytical chemist at Pfizer, advanced to a project leadership role, and served as a Team Leader at Almac Sciences. He holds a Bachelor's with Honors in Chemical and Pharmaceutical Sciences from the University of Sunderland.

Erik Atkisson, Chief Legal Officer

Mr. Atkisson was appointed Chief Legal Officer at Achieve Life Sciences in October 2025, bringing over 25 years of experience in the pharmaceutical and biotechnology industries. He possesses deep expertise in guiding the global development, launch, and commercialization of biopharmaceutical products. Prior to Achieve, Mr. Atkisson served as General Counsel, Corporate Secretary, and Chief Compliance Officer at Rain Oncology. His previous roles include General Counsel of Eiger BioPharmaceuticals and Chief Compliance Officer of Cytokinetics, as well as senior positions at Amneal Pharmaceuticals and BioMarin Pharmaceutical. Mr. Atkisson earned a J.D. from Georgetown University Law Center, an M.Sc. from the University of Edinburgh, and a B.A. from Harvard University.

Jaime Xinos, Chief Commercial Officer

Ms. Xinos has served as the Chief Commercial Officer at Achieve Life Sciences since October 2024. She previously held the position of Executive Vice President of Commercial at Achieve, a role she assumed upon joining the company in 2017. Before Achieve, Ms. Xinos was Vice President, Marketing and Corporate Communications at OncoGenex Pharmaceuticals, an oncology biopharmaceutical company, where she started as Senior Director, Global Oncology Commercial Development in 2010. Her earlier career included various commercial roles in marketing, commercial development, and sales at Pfizer, Novartis, and Abbott Laboratories.

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The key risks for Achieve Life Sciences (ACHV) are primarily centered around regulatory approval, commercialization challenges, and its financial position.

1. Regulatory Approval of Cytisinicline: The most significant risk for Achieve Life Sciences is the successful regulatory approval of its sole product candidate, cytisinicline. The company's future is highly dependent on the FDA's decision, with a Prescription Drug User Fee Act (PDUFA) date set for June 20, 2026. Despite positive Phase 3 results, there is no guarantee of FDA approval, and any delays or outright rejection would have a material adverse impact on the business.
2. Commercialization Challenges and Pipeline Concentration: Even if cytisinicline receives FDA approval, Achieve Life Sciences faces substantial challenges in successfully commercializing the drug in a competitive market. The company's future depends almost entirely on the success of cytisinicline, indicating a heavy pipeline concentration risk. The smoking cessation market has historically presented difficulties with low long-term quit rates and patient adherence, and the company will need to convince both patients and insurance companies of the drug's value.
3. Financial Health and Need for Additional Financing: As a clinical-stage pharmaceutical company, Achieve Life Sciences currently operates without commercial revenue and incurs significant operating losses. While recent financing has extended its cash runway into the second half of 2026, this period leaves little margin beyond the anticipated FDA decision date. The company's substantial cash burn rate suggests a continued reliance on external financing for ongoing operations, pre-commercialization activities, and potential future clinical trials. This need for additional capital poses a material risk of future shareholder dilution.

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The successful re-entry and widespread availability of Pfizer's varenicline (Chantix) into the market for smoking cessation. Prior to its voluntary recall due to impurities, varenicline was a highly effective and leading prescription medication globally. Pfizer has received regulatory approvals for new manufacturing processes and is working to restore its supply. The re-emergence of this established and potent competitor would directly challenge Achieve Life Sciences' cytisinicline, which is positioned to address the significant unmet need for an effective, non-nicotine prescription option for smoking and vaping cessation that arose from varenicline's absence.

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Achieve Life Sciences' main product is cytisinicline, which is being developed for smoking cessation and e-cigarette/vaping cessation.

The addressable markets for cytisinicline are as follows:

• Smoking Cessation (Combustible Cigarettes):
  • The global smoking cessation product market is projected to reach $69.8 billion by 2034.
  • The global market size for cytisine (which includes cytisinicline) is expected to reach USD 5.14 billion by 2035, growing from USD 1.58 billion in 2024.
  • In the United States, there are approximately 29 million adults who smoke combustible cigarettes.
  • The market size of smoking cessation and nicotine addiction in the United States was approximately USD 1.47 billion in 2022.
• E-cigarette or Vaping Cessation:
  • In the United States, there are over 11 million adults who use e-cigarettes (vaping). Other estimates suggest approximately 17 million adults in the U.S. use e-cigarettes.
  • There are no FDA-approved treatments specifically indicated for nicotine vaping cessation, and cytisinicline has the potential to address the over 13 million people in the United States who vape nicotine and are struggling to quit.

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Expected Drivers of Future Revenue Growth for Achieve Life Sciences (ACHV)

Over the next 2-3 years, Achieve Life Sciences (ACHV) is anticipated to drive revenue growth primarily through the following key initiatives:

1. Commercial Launch of Cytisinicline for Smoking Cessation: The primary driver of future revenue is the successful commercialization of cytisinicline as a treatment for nicotine dependence for smoking cessation. The company submitted its New Drug Application (NDA) to the FDA in June 2025, with a Prescription Drug User Fee Act (PDUFA) date set for June 20, 2026. Achieve Life Sciences anticipates a commercial launch in late 2026, positioning cytisinicline as the first new prescription smoking cessation drug in nearly two decades, targeting a substantial unmet medical need. The company is implementing a focused launch strategy leveraging innovative, data-driven solutions and has established a strategic commercial partnership with Omnicom to co-develop and execute an integrated launch strategy, aiming to optimize performance and reduce commercial buildout costs.
2. Expansion into Vaping Cessation Market: Achieve Life Sciences has received a Commissioner's National Priority Voucher (CNPV) from the FDA for cytisinicline's vaping indication, which is expected to expedite the regulatory review timeline and could lead to a launch approximately 8 months earlier than a standard review process. This accelerated pathway positions cytisinicline to potentially become the first FDA-approved treatment for vaping cessation, addressing a significant and growing public health crisis, particularly among younger demographics. The company is targeting Q3 2025 to commence the Phase 3 clinical trial for vaping cessation.
3. Penetration of Specific Patient Populations (e.g., COPD patients): Clinical trial results have demonstrated that smokers with Chronic Obstructive Pulmonary Disease (COPD) achieved higher quit rates with cytisinicline compared to placebo, even with more severe tobacco use histories. This positive outcome highlights cytisinicline's potential to effectively treat a difficult-to-treat patient population, thereby broadening its therapeutic applicability and market potential. Expanding market reach to patient groups like those with COPD represents a strategic opportunity for revenue growth.
4. Strategic Commercialization and Market Adoption through AI-Driven Strategy: Achieve Life Sciences is leveraging an AI and machine learning-driven commercial strategy to optimize campaigns, enhance engagement across healthcare professionals, patients, and payers, and drive adoption. This innovative approach is designed to be scalable and cost-efficient, supporting favorable payer coverage decisions and building product-specific awareness ahead of and during commercial launch. Early engagement with payers is a top priority to ensure rapid access following approval.

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Share Issuance

• Achieve Life Sciences completed a public offering, pricing $45 million to advance cytisinicline development for smoking cessation.
• The number of outstanding shares increased by 35.97% in one year.
• As of November 2025, the company had 34,685,072 shares outstanding.

Inbound Investments

• On December 22, 2021, Achieve Life Sciences entered into a $25.0 million contingent convertible debt agreement with Silicon Valley Bank.

Capital Expenditures

• Achieve Life Sciences has deferred expenses and capital expenditures into the second half of 2025, potentially focusing on the NDA submission to the FDA for cytisinicline.