Aquestive Therapeutics’ Earnings Call: Mixed Outlook

Aquestive Therapeutics, Inc. ((AQST)) has held its Q1 earnings call. Read on for the main highlights of the call.

Aquestive Therapeutics’ Latest Earnings Call: A Mixed Outlook

The recent earnings call from Aquestive Therapeutics, Inc. presented a mixed outlook, reflecting both challenges and opportunities. While the company is making significant strides in the FDA review process and commercial preparations for its promising product, Anaphylm, it is also grappling with substantial revenue declines and increased losses. The anticipation surrounding Anaphylm’s potential market entry provides a glimmer of optimism amidst these financial hurdles.

Anaphylm FDA Review Progress

Aquestive Therapeutics is currently over a month into the FDA review process for Anaphylm, its Epinephrine Sublingual film. The company anticipates an FDA action date in late January or early February of 2026. This progress marks a critical step forward for Aquestive as it seeks to bring this innovative product to market.

Commercial Prelaunch Phase for Anaphylm

The company has officially entered the commercial prelaunch phase for Anaphylm. Aquestive is focusing on assembling a marketing team with significant experience, including members who previously contributed to building EpiPen into a billion-dollar brand. This strategic move underscores the company’s commitment to ensuring a successful product launch.

Increased Awareness Efforts

Aquestive has been actively increasing awareness for Anaphylm by attending 25 conferences and publishing 16 posters and manuscripts. The company plans to reach a total of 30 publications by the FDA action date, demonstrating its dedication to establishing a strong presence in the market.

Strategic Payer Engagement

To prepare for Anaphylm’s launch, Aquestive is leveraging existing distribution and payer contracts. This strategic engagement aims to save months of startup time, positioning the company for a swift and efficient market entry.

Significant Revenue Decrease

The earnings call revealed a significant decrease in total revenues, which fell by 28% to $8.7 million in Q1 2025 compared to $12.1 million in Q1 2024. This decline was primarily driven by decreases in manufacturer and supply revenue, highlighting the financial challenges the company is currently facing.

Increased Net Loss

Aquestive reported a net loss of $22.9 million for Q1 2025, compared to $12.8 million in Q1 2024. This increase in net loss is largely attributed to heightened selling, general, and administrative expenses, reflecting the financial pressures on the company.

Libervant Revenue Removal

The company revised its financial guidance, excluding revenue for Libervant due to a change in regulatory status. This revision impacts the expected total revenue for 2025, further emphasizing the financial adjustments Aquestive is making in response to regulatory developments.

Non-GAAP Adjusted EBITDA Loss

Aquestive’s non-GAAP adjusted EBITDA loss was $17.6 million in Q1 2025, compared to a $7.2 million loss in Q1 2024. This increase in losses highlights the financial challenges the company is navigating as it prepares for Anaphylm’s potential market entry.

Forward-Looking Guidance

During the earnings call, CEO Dan Barber provided forward-looking guidance, emphasizing the company’s focus on Anaphylm’s commercial prelaunch phase. The anticipated FDA action date in early 2026 remains a pivotal milestone. Financially, Aquestive revised its full-year 2025 revenue guidance to between $44 million and $50 million, with a non-GAAP adjusted EBITDA loss projected between $47 million and $51 million. The company plans to de-emphasize AQST-108 studies to allocate more resources towards Anaphylm’s launch, aiming for a robust start in 2026 if FDA approval is secured.

In conclusion, Aquestive Therapeutics’ latest earnings call reflects a mixed sentiment, with both promising developments and financial challenges. The company’s strategic preparations for Anaphylm’s potential launch offer a hopeful outlook, despite the current revenue declines and increased losses. Investors and market watchers will be keenly observing the FDA’s decision and Aquestive’s subsequent steps in the coming months.