Aquestive Therapeutics, Inc. ((AQST)) has held its Q2 earnings call. Read on for the main highlights of the call.
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Aquestive Therapeutics’ recent earnings call painted a picture of both optimism and caution. The company is making significant strides in the development and pre-launch activities for its promising product, Anaphylm, which could open up substantial market opportunities. However, financial hurdles such as declining revenues and increased net losses, coupled with market access challenges, remain pressing concerns for the company.
FDA Review and Launch Preparation for Anaphylm
Aquestive Therapeutics is progressing well with the FDA review process for Anaphylm, its sublingual epinephrine film. The company is actively engaged in pre-commercial launch activities and has secured the necessary launch financing. The FDA action date is set for January 31, 2026, marking a significant milestone in the company’s timeline.
Market Opportunity for Anaphylm
The market for severe allergic reaction treatments is poised for substantial growth, with surveys indicating a shift from injectable to non-injectable products. Aquestive is well-positioned to capitalize on this trend, with the potential market size reaching up to $2 billion annually.
International Expansion Plans
Aquestive is not limiting its ambitions to the domestic market. The company has secured meetings with regulatory bodies in Canada and the EU, aiming to complete these by the end of the year. These efforts are part of their strategy to prepare for international filings and expand their global footprint.
Base Business Growth
Despite challenges, Aquestive’s base business demonstrated year-over-year growth in Q2 2025, primarily driven by strong international product performance. This growth highlights the company’s ability to maintain a solid foundation while pursuing new opportunities.
Cash Position and Financial Stability
The company ended the last quarter with a robust cash position of $60 million, which is deemed sufficient for the initial launch of Anaphylm. Aquestive is also exploring additional funding options to ensure continued financial stability.
Revenue Decline
Aquestive reported a decrease in total revenues from $20.1 million in Q2 2024 to $10 million in Q2 2025. This decline was attributed to a one-time recognition of deferred revenue in the prior year. Excluding this, the company achieved a modest revenue increase of 3%.
Increased Net Loss
The net loss for Q2 2025 was $13.5 million, compared to $2.7 million in Q2 2024. However, when excluding deferred revenue, the net loss in Q2 2024 was $13.2 million, indicating a relatively stable financial performance.
Increased Operating Expenses
Operating expenses rose to $12.7 million in Q2 2025 from $11.4 million in Q2 2024. This increase was driven by higher commercial spending and regulatory fees, reflecting the company’s investment in its future growth.
Challenges in Market Access
Aquestive faces significant barriers in the market access landscape, including delay tactics and prior authorization documentation. These challenges make it difficult for patients to access life-saving medicines, highlighting a critical area for the company to address.
Forward-Looking Guidance
Aquestive Therapeutics remains on track with its FDA review process for Anaphylm, with an action date set for early 2026. The company is preparing for a potential launch, focusing on securing financing and increasing product awareness. The rescue market for severe allergic reactions is expected to grow significantly, with potential global market value exceeding $2 billion. Aquestive’s financial guidance for 2025 remains unchanged, with expected revenues between $44 million and $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million.
In conclusion, Aquestive Therapeutics’ earnings call reflects a company at a crossroads, balancing promising opportunities with significant challenges. While the development of Anaphylm and international expansion plans offer exciting prospects, financial hurdles and market access barriers require careful navigation. Investors and stakeholders will be keenly watching how the company maneuvers through these complexities in the coming quarters.