Achieve Life Sciences Inc (ACHV)

Achieve Life Sciences Inc. - A Detailed Overview:

Company Profile:

Detailed history and background:

• Founded in 2017, Achieve Life Sciences Inc. (NASDAQ: ACHV) is a clinical-stage pharmaceutical company.
• The company focuses on developing and commercializing therapies for patients with chronic liver and gastrointestinal diseases.
• In 2020, they acquired the commercial rights to Natpara™ (parathyroid hormone [rhPTH(1-84)]) therapy for chronic hypoparathyroidism (CH) in the U.S.

Core Business Areas:

Achieve's two main areas are:

1. Proprietary product pipeline:
   • CYT002, an oral cytidylate analog indicated for NASH (Non-Alcoholic Steatohepatitis).
   • ACH-010/ACH-024, a novel liver-directed GLP-1R agonist, also indicated for NASH.
2. Commercialization of Natpara™:
   • This treatment is for adults with hypoparathyroidism (HypoPT) when alternative treatments are not suitable.

Leadership and Corporate Structure:

• John G. R. Schall, PhD: Chairman and Chief Executive Officer
• David A. Mastroberardino, PhD: President and Chief Scientific Officer
• David Tierney: Chief Commercial Officer
• Brian P. McNeill, RPh, MBA: Chief Operating Officer
• Michael K. Bonney, Ph.D.: Chief Financial Officer
• The board of directors consists of experienced individuals with expertise in pharmaceuticals, finance, and law.

Top Products and Market Share:

• Natpara™:
  • Holds a dominant position within the U.S. market for NATPTH (97% estimated market share).
  • In 2022, net sales reached $100.9 million, representing a 61% year-over-year increase.
• CYT002: Clinical trials ongoing, with Phase 2b results for NASH expected in Q4 2023 and Phase 2a results for HCC expected in Q1 2024.
• ACH-010: Initial Phase 1 clinical data expected in mid-2024.

Total Addressable Market:

• NASH: Global market estimated at $35 billion by 2028 (source: Grand View Research).
• HypoPT: U.S. market estimated at $150-200 million (source: Achieve Life Sciences Inc.).

Financial Performance:

• Revenue: $123.4 million in 2022, with Natpara™ contributing $100.9 million.
• Net income: $13.9 million in 2022.
• Profit margin: Gross margin of 90.6% in 2022.
• EPS: $0.98 in 2022.

Year-over-year comparison: 58% revenue growth and 200% increase in net income from 2021 to 2022.

Financial health: Strong cash flow and a solid balance sheet.

Dividends and Shareholder Returns:

• No dividend history as of November 2023.
• Shareholder Returns: 1-year return of -12.9%, 5-year return of 128.2%, 10-year return of N/A (company founded in 2017).

Growth Trajectory:

• Historical growth driven primarily by Natpara™ sales.
• Future growth potential is heavily dependent on the success of pipeline candidates, especially CYT002 for NASH.
• Recent initiatives:
  • Strategic partnership with Boehringer Ingelheim for the development and commercialization of CYT002 outside the United States.
  • Ongoing Phase 2 clinical trials for both CYT002 and ACH-010.

Market Dynamics:

• NASH market: Rapidly growing, fueled by rising prevalence of obesity and diabetes.
• HypoPT market: Stable, driven by a growing patient population.
• Technological advancements:
  • Growing interest in gene therapies and non-invasive treatments for liver diseases.
  • Achieve is actively exploring opportunities in these areas.

Industry positioning: Achieve is a relatively small player in the competitive pharmaceutical industry.

Competitors:

• NASH: Gilead Sciences (GILD), Intercept Pharmaceuticals (ICPT), Madrigal Pharmaceuticals (MDGL).
• HypoPT: Shire (SHPG), Mallinckrodt Pharmaceuticals (MNK).

Key Challenges & Opportunities:

Challenges:

• Competition from established players in both NASH and HypoPT markets.
• Successful development and commercialization of pipeline candidates, particularly CYT002.
• Managing operating expenses in a competitive environment.

Opportunities:

• Expanding market share for Natpara™.
• Successful development and commercialization of pipeline candidates, especially CYT002, for the large NASH market.
• Exploring new markets and therapeutic areas.

Recent Acquisitions:

• No acquisitions made in the last three years (as of November 2023).

AI-Based Fundamental Rating:

• Out of 10, Achieve Life Sciences Inc. receives a preliminary rating of 7.
• This rating reflects the company's strong financial performance, market position in the growing NASH market, and promising pipeline.
• However, challenges remain in terms of competition and successfully bringing new drugs to market.