Upcoming FDA Approval Will Enable Needle-Free Epinephrine Adoption

Key Takeaways

• The FDA review and potential success of Anaphylm could drive strong revenue growth and shift market preference toward needle-free drug delivery.
  
• Strategic investments in awareness, payer access, and product pipeline position the company for rapid adoption, diversified revenue, and improved margins.
  
• Heavy reliance on Anaphylm's market success, payer barriers, funding needs, and intense competition threaten sustained growth, profitability, and shareholder value.

Catalysts

Operates as a pharmaceutical company in the United States and internationally.

• The upcoming potential FDA approval and commercial launch of Anaphylm, a first-of-its-kind orally administered epinephrine film, positions Aquestive to capitalize on increasing patient and provider demand for convenient, needle-free drug administration, supporting meaningful future revenue growth if successful.
  
• Broad physician and patient preference for non-injectable formats, coupled with survey data indicating significant anticipated market share shift toward these alternatives, suggests Anaphylm could accelerate prescription volumes and, if adopted, drive substantial topline revenue expansion.
  
• Aquestive's active pre-commercial investment in market awareness, payer engagement, and parallel cash-pay and insurance reimbursement strategies aims to overcome typical launch access barriers, potentially supporting faster adoption rates and improved net margins following launch.
  
• The company's continued pipeline advancement-highlighted by progression of AQST-108 (epinephrine topical gel for alopecia areata) and international regulatory initiatives-provides multiple shots on goal, increasing prospects for long-term revenue diversification and reduced earnings volatility.
  
• Aquestive's ability to leverage secular growth in at-home and telehealth care settings, together with operational resilience due to an unaffected U.S.-based supply chain, positions the company for durable manufacturing and distribution efficiencies, potentially enhancing margins and supporting sustainable earnings growth.

Aquestive Therapeutics Future Earnings and Revenue Growth

Assumptions

• Analysts are assuming Aquestive Therapeutics's revenue will grow by 42.1% annually over the next 3 years.
• Analysts are not forecasting that Aquestive Therapeutics will become profitable in next 3 years. To represent the Analyst Price Target as a Future PE Valuation we will estimate Aquestive Therapeutics's profit margin will increase from -147.4% to the average US Pharmaceuticals industry of 23.2% in 3 years.
• If Aquestive Therapeutics's profit margin were to converge on the industry average, you could expect earnings to reach $29.4 million (and earnings per share of $0.24) by about August 2028, up from $-65.0 million today.
• In order for the above numbers to justify the analysts price target, the company would need to trade at a PE ratio of 42.5x on those 2028 earnings, up from -6.3x today. This future PE is greater than the current PE for the US Pharmaceuticals industry at 19.8x.
• Analysts expect the number of shares outstanding to grow by 7.0% per year for the next 3 years.
• To value all of this in today's terms, we will use a discount rate of 6.78%, as per the Simply Wall St company report.

Aquestive Therapeutics Future Earnings Per Share Growth

Risks

• The company's future revenue growth is heavily dependent on the successful FDA approval and adoption of Anaphylm; if the product is delayed or does not achieve meaningful market share due to competition, regulatory issues, or clinical shortcomings, it could materially impact revenues and delay or diminish earnings.
  
• Increasing scrutiny and barriers from payers, such as high deductibles, prior authorizations, and coverage limitations-as observed with competitors-pose ongoing risks to broad market access for Anaphylm, which could suppress net margins and limit the company's ability to drive profitable growth.
  
• The company's relatively low scale and limited commercial infrastructure, combined with reliance on external financing to support Anaphylm's launch, increases the risk of inefficient product roll-out, higher-than-expected SG&A costs, or shareholder dilution, all of which could negatively affect net operating margins and shareholder value.
  
• Aquestive continues to report significant net losses and negative adjusted EBITDA, and with the need for additional financing and ongoing high R&D and commercial spending, there is a risk that future investment in pipeline growth could require further dilutive funding or restrain earnings potential.
  
• The industry continues to see heightened competition in the epinephrine rescue market (e.g., injectables, nasal sprays, and other non-injectable formats) as well as potential advances in alternative drug delivery technologies, which could erode the addressable market for Anaphylm, put pressure on pricing, and thus impact long-term revenue and margin expansion.

Valuation

• The analysts have a consensus price target of $8.417 for Aquestive Therapeutics based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of $15.0, and the most bearish reporting a price target of just $4.75.
  
• In order for you to agree with the analyst's consensus, you'd need to believe that by 2028, revenues will be $126.5 million, earnings will come to $29.4 million, and it would be trading on a PE ratio of 42.5x, assuming you use a discount rate of 6.8%.
  
• Given the current share price of $4.11, the analyst price target of $8.42 is 51.2% higher.
  
• We always encourage you to reach your own conclusions though. So sense check these analyst numbers against your own assumptions and expectations based on your understanding of the business and what you believe is probable.