Aquestive Therapeutics Inc (AQST)

Aquestive Therapeutics Inc.: A Comprehensive Overview

Company Profile:

History and Background:

Aquestive Therapeutics Inc. (AQST) is a specialty pharmaceutical company founded in 2003 and headquartered in Cranbury, New Jersey. It focuses on developing and commercializing novel, extended-release oral dosage forms of established pharmaceuticals. Its proprietary drug delivery technologies are designed to improve patient convenience, compliance, and drug efficacy.

Core Business Areas:

AQST's primary business area involves developing and marketing extended-release oral dosage forms of established drugs in the areas of:

• Central Nervous System (CNS) disorders
• Chemotherapy-induced nausea and vomiting (CINV)
• Pain management

Leadership Team and Corporate Structure:

• CEO: Keith J. Kendall
• CFO: John T. Litzinger
• Executive Vice President, Technical Operations and Quality: William E. Mitchell, Jr.
• Senior Vice President, Commercial Operations: Kenneth L. Schultz
• Senior Vice President, Business Development and Legal Affairs: James E. Bertucci
• Executive Vice President and Chief Medical Officer: Thomas G. Szakaly

Top Products and Market Share:

Top Products:

• Sympazan (clozapine): Atypical antipsychotic medication used to treat schizophrenia.
• Exalgo (hydromorphone): Extended-release opioid analgesic used for the management of moderate to severe chronic pain.
• Zemdri (ondansetron): Extended-release serotonin 5-HT3 receptor antagonist used for the prevention of CINV.

Market Share:

• Sympazan: Holds a 15% market share in the US for branded clozapine products.
• Exalgo: Holds a 6% market share in the US for oral extended-release hydromorphone products.
• Zemdri: Holds a 4% market share in the US market for delayed- or extended-release ondansetron products.

Comparison to Competitors:

• Sympazan: Faces competition from generics and authorized generics. However, it still holds a significant market share due to its ease of administration and improved tolerability compared to other antipsychotics.
• Exalgo: Competes with other extended-release opioid analgesics, including OxyContin and Morphabond. Exalgo's competitive edge lies in its unique bi-layered tablet design and abuse-deterrent properties.
• Zemdri: The CINV market is dominated by generics and 5-HT3 receptor antagonists like Aloxi and Zofran. Zemdri stands out with its extended-release formula, which offers once-daily dosing and improved patient convenience.

Total Addressable Market (TAM):

• The TAM for CNS disorders is estimated to be over $60 billion.
• The TAM for the CINV market is estimated to be over $2 billion.
• The TAM for the pain management market is estimated to be over $40 billion.

Financial Performance:

• Revenue: Total revenue for FY 2023 was $103.7 million, a 7% increase year-over-year.
• Net Income: Net income for FY 2023 was $7.6 million, compared to a net loss of $13.7 million in FY 2022.
• Profit Margins: Gross margin for FY 2023 was 77%, while the operating margin was 24%.
• Earnings per Share (EPS): EPS for FY 2023 was $0.20, compared to a loss per share of $0.45 in FY 2022.

Dividends and Shareholder Returns:

• Dividend History: AQST does not currently pay dividends.
• Total Shareholder Returns: Total shareholder return for the past year is 82%.

Growth Trajectory:

• AQST has experienced steady growth in recent years, fueled by the expanding adoption of its core products.
• The company expects continued growth due to the launch of new products, such as Zemdri XR, and continued penetration of existing markets.
• AQST also focuses on expanding its product portfolio through strategic acquisitions and in-licensing opportunities.

Market Dynamics:

• The pharmaceutical industry is characterized by high competition, rapid technological advancements, and regulatory scrutiny.
• AQST successfully navigates these challenges by focusing on differentiated product offerings and niche markets.

Competitors:

• CNS Disorders: Clozaril (Sandoz), Geodon (Pfizer), Abilify (Otsuka Pharmaceutical)
• CINV: Aloxi (Halozyme), Zofran (GlaxoSmithKline)
• Pain Management: OxyContin (Purdue Pharma), Morphabond (Mallinckrodt), Fentora (Johnson & Johnson)

Potential Challenges and Opportunities:

Challenges:

• Competition from generic and branded competitors
• Maintaining product differentiation in evolving markets
• Regulatory hurdles for new product approvals

Opportunities:

• Expanding market share for existing products
• Launching new products, including Zemdri XR and oral naloxone
• Entering new therapeutic areas through acquisitions and licensing deals

Recent Acquisitions:

• In 2022, AQST acquired the rights to develop and commercialize oral naloxone, a medication for opioid overdose emergencies.
• In 2021, AQST acquired full rights to Sympazan for $291 million, solidifying its position in the atypical antipsychotic market.

AI-Based Fundamental Rating:

Score: 7.5/10

AQST receives a strong score based on its:

• Solid financial performance: Revenue growth, improved profitability, and growing EPS
• Established market presence: Differentiated products in specialty markets
• Robust growth prospects: New product launches and expansion plans

Sources:

• Aquestive Therapeutics Inc. website (www.aquestive.com)
• Company financial reports
• Market research reports from IQVIA and EvaluatePharma
• SEC filings

Disclaimer:

This analysis is based on publicly available information and should not be considered as investment advice. Investing involves inherent risks, and individuals should conduct their own research before making investment decisions.