1. Executive Summary
- Company: Aquestive Therapeutics Inc.
- Ticker: AQST
- Sector: Biopharmaceuticals / Drug Delivery Technology
- Current Price: $2.35
- Market Cap: ~$239.3 million
- Analyst Rating: 6 out of 6 analysts rate the stock as “Buy”
- Average Price Target: $10.67, suggesting over +350% upside potential (Source: MarketBeat)
2. Company Overview
- Business Model: Aquestive develops and commercializes proprietary PharmFilm® technology, which allows medications to be administered via oral thin films, improving patient compliance and ease of use.
- Industry Position: A market leader in oral film drug delivery systems with strong partnerships and a growing portfolio.
- Key Products:
- Sympazan® (for epilepsy)
- Libervant™ (benzodiazepine for seizure rescue)
- Anaphylm™ (for anaphylaxis, currently under FDA review)
- Management: CEO Daniel Barber; headquartered in Warren, New Jersey.
3. Financial Analysis
- Revenue: Q1 2025 revenue was $8.7 million, down 28% YoY, mainly due to reduced manufacturing/supply revenue.
- Net Loss: Q1 2025 net loss was $22.9 million, wider than the same period in 2024.
- EPS: Q1 2025 EPS was –$0.24, lower than last year’s.
- Cash: As of March 31, 2025, cash and equivalents stood at $68.7 million.
- Cash Flow: Q1 2025 operating cash flow was –$17.6 million, showing deterioration in liquidity.
4. Stock Performance
- 1-Year Trend: The stock is down roughly 26% over the past year.
- Dividend: No dividends paid.
- Volatility: No beta data available, but price shows significant fluctuations.
- Recent Catalysts: On May 12, 2025, the company submitted a New Drug Application (NDA) to the FDA for Anaphylm™.
5. Valuation Analysis
- P/E Ratio: Not applicable (net losses)
- P/S Ratio: ~4.2 — relatively high for its revenue size
- P/B Ratio: Not disclosed
- DCF Analysis: Requires long-term assumptions due to pre-profit stage
- Industry Comparison: Technologically advanced, but challenged by commercialization delays and ongoing losses
6. Industry & Market Analysis
- Trends: Rising interest in non-invasive drug delivery systems, including film-based medications, due to ease of use and better compliance
- Market Position: Leading player in its niche with FDA-approved and pipeline products
- Macro Factors: Subject to regulatory timelines, FDA approvals, and broader biotech market volatility
7. Risk Analysis
- Market Risk: Delays in product launches or competitive approvals could impact growth
- Financial Risk: Continued losses and cash burn may require future funding
- Regulatory Risk: FDA review delays or rejections could affect product rollout
- Geopolitical Risk: Regulatory and commercial risks in international markets
8. Growth Catalysts
- New Product: Anaphylm™, if approved by the FDA, could provide a major new revenue stream
- Expansion: Opportunity to expand current product sales and establish new partnerships
- M&A: No major M&A to date, but strategic alliances are possible
- Industry Tailwinds: Demand for convenient and fast-acting treatments continues to grow
9. Analyst Sentiment
- Consensus Rating: Buy
- Price Target: $10.67
- Recent News: NDA submission for Anaphylm™ was positively received, increasing optimism for FDA approval and commercial launch (Source: MarketBeat)
10. Conclusion
Aquestive Therapeutics is a high-potential biotech company focused on oral film drug delivery. With a robust pipeline, including Anaphylm™ under FDA review, and strong analyst support, it presents a compelling case for speculative investors. However, cash burn and regulatory risks should be carefully weighed. The stock could reward long-term investors if product approvals and commercialization succeed.