Aquestive Therapeutics, Inc. ((AQST)) has held its Q4 earnings call. Read on for the main highlights of the call.
Aquestive Therapeutics’ recent earnings call highlighted a mixed sentiment, reflecting both significant strides and notable challenges. The company has made commendable progress in advancing its lead asset, Anaphylm, towards FDA approval and is gearing up for international expansion. However, the earnings call also revealed hurdles such as decreased quarterly revenue, increased net loss, and legal setbacks concerning Libervant.
FDA Filing for Anaphylm
Aquestive Therapeutics has initiated the filing process with the FDA for Anaphylm, an epinephrine sublingual film. The company anticipates the NDA acceptance by June 2025, with a potential market launch in the first quarter of 2026. This marks a significant step in bringing a new treatment option to the market.
Pediatric Study Progress for Anaphylm
The pediatric study for Anaphylm is progressing as planned, with data supporting the product label to align with existing EpiPen auto-injector parameters. This progress is crucial for ensuring the product’s efficacy and safety for younger patients.
International Expansion Plans
Aquestive is preparing to submit applications for Anaphylm in the EU, UK, and Canada. The company is also exploring partnerships outside the U.S. to aid in the product’s commercialization, indicating a strategic move to broaden its market reach.
Development of AQST-108
Aquestive plans to open an Investigational New Drug (IND) application for AQST-108, a topical gel formulation of epinephrine. A Phase 2a trial is expected to commence in the next quarter, showcasing the company’s commitment to expanding its product pipeline.
Revenue Growth in 2024
The company reported a 14% increase in total revenues for the full year 2024, amounting to $57.6 million. This growth was primarily driven by increases in license and royalty revenue, highlighting a positive financial trajectory.
Decreased Revenue in Q4 2024
Conversely, Q4 2024 saw a 10% decrease in total revenue, down to $11.9 million. This decline was mainly due to reductions in license and royalty revenue, reflecting some financial volatility.
Increased Net Loss
Aquestive’s net loss for Q4 2024 more than doubled to $17.1 million from $8.1 million in Q4 2023. This increase was driven by higher expenses and reduced revenues, posing a challenge for the company.
Court Ruling Against Libervant
A federal court ruling challenged the FDA’s rationale for granting Libervant approval and orphan drug exclusivity, prompting Aquestive to appeal. This legal setback adds a layer of complexity to the company’s strategic plans.
Decreased Suboxone and Sympazan Revenues
The company experienced a decline in manufacture and supply revenue due to decreased sales of Suboxone and Sympazan. However, this was partially offset by increases in other product revenues.
Forward-Looking Guidance
Aquestive Therapeutics provided forward-looking guidance, expecting FDA approval for Anaphylm in Q1 2026, with NDA acceptance anticipated in June 2025. The company plans to initiate the AQST-108 Phase 2a clinical trial in the next quarter. Financially, they project revenues between $47 million and $56 million for 2025, considering potential Suboxone demand erosion and including Libervant sales for ages 2 to 5. The company remains committed to pre-commercial preparations for Anaphylm and Libervant commercialization despite ongoing legal challenges.
In summary, Aquestive Therapeutics’ earnings call presented a balanced view of progress and challenges. While the company is making headway with Anaphylm and expanding internationally, it faces financial and legal hurdles. Investors will be keenly watching how these developments unfold, particularly the anticipated FDA approval and international market entries.
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