Achieve Life Sciences Inc (ACHV)

History and Background

Achieve Life Sciences Inc. (ACHV) is a pharmaceutical company focused on developing and commercializing cytisine for smoking cessation and nicotine addiction. Founded in 2006, the company acquired the global rights to cytisine, establishing its focus on this molecule for addiction treatment.

Core Business Areas

• Pharmaceutical Development: Focuses on the development and clinical trials of cytisine-based therapies for smoking cessation.
• Commercialization: Aims to commercialize cytisine therapies globally, partnering with other pharmaceutical companies in other countries

Leadership and Structure

The leadership team consists of experienced pharmaceutical executives. The organizational structure includes departments for research and development, clinical trials, regulatory affairs, and commercial operations.

Key Offerings

• Cytisine: Achieve's primary focus is on cytisine, a plant-based alkaloid with a similar mechanism of action to nicotine, but with a lower binding affinity to nicotine receptors. It is in clinical trials for smoking cessation (Phase 3). Market share is currently negligible but could become large if approved by the FDA and EMA. Competitors include nicotine replacement therapies (NRTs) like nicotine patches and gums, and prescription drugs like varenicline (Chantix).

Industry Overview

The smoking cessation market is driven by public health initiatives, rising awareness of the health risks of smoking, and government regulations. It is also driven by the addictive nature of nicotine, and the number of patients that are affected by it globally. It is a large market with significant unmet needs, especially for accessible and affordable treatments.

Positioning

Achieve aims to position cytisine as a safe and effective alternative to existing smoking cessation treatments, with the potential for broader accessibility due to its lower cost. It could become the leading smoking cessation method.

Total Addressable Market (TAM)

The global smoking cessation market is estimated to be worth billions of dollars. Achieve is positioned to capture a significant share of this market if cytisine receives regulatory approval and gains market acceptance. The TAM can be considered the population of smokers worldwide looking to quit. The global TAM in 2024 for smoking cessation products is expected to be $8.7 Billion

Key Competitors

• PFE
• JNJ
• OTCQX:NVPVY

Competitive Landscape

Achieve competes with established pharmaceutical companies in the smoking cessation market. Its advantage is Cytisine's lower cost and accessibility, but it lacks the marketing and distribution infrastructure of larger competitors.

Historical Growth: Achieve's historical growth is characterized by milestones in clinical trials and drug development.

Future Projections: Future growth is dependent on the successful completion of Phase 3 trials for Cytisine, FDA approval, and subsequent commercialization. Analyst projections are based on the potential market share of Cytisine.

Recent Initiatives: Recent initiatives include completing enrollment in the ORCA-3 trial and preparing for ORCA-V1.

Achieve Life Sciences is a developmental stage company with a promising smoking cessation drug candidate. It has limited revenue and is burning through cash but is poised for significant growth with successful trial outcomes and FDA approval. Investors should closely monitor trial results and regulatory progress. The company's success hinges on the successful development and commercialization of Cytisine.

Data Sources:

• Company Filings (SEC)
• Analyst Reports
• Market Research Reports
• Company Website
• ClinicalTrials.gov

Disclaimers:

The information provided is for informational purposes only and does not constitute financial advice. Investment decisions should be made based on individual research and due diligence. Market share data is an estimate.