Aquestive Therapeutics Announces Q1 2024 Financial Results and Business Update

Aquestive Therapeutics, Inc., a pharmaceutical company specializing in innovative drug delivery technologies, has announced its financial results for the first quarter of 2024 and provided updates on its recent business developments. The company reported an 8% increase in total revenue, reaching $12.1 million compared to $11.1 million in the same period the previous year. This growth was primarily driven by higher revenue from out-licensed products.

Key developments include the successful completion of the Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film, which met all endpoints when compared to EpiPen® and other injectors for treating anaphylaxis. The company is on track to complete the temperature/pH study for Anaphylm in the second quarter of 2024 and has received positive feedback from the FDA on self-administration and allergen exposure protocols. Aquestive aims to file a New Drug Application (NDA) for Anaphylm with the FDA by the end of 2024.

In the first quarter of 2024, Aquestive also received FDA approval for Libervant™ (diazepam) Buccal Film for patients aged two to five. This approval marks the company's fourth FDA approval since 2018. Libervant is the first FDA-approved orally administered rescue medication for seizure clusters in this age group and is available in various dosages. The company is committed to expanding market access for Libervant to patients older than five years and is working to overcome an existing orphan drug market exclusivity block that extends until January 2027.

Aquestive continues to advance its Adrenaverse™ platform with AQST-108, an epinephrine prodrug topical gel for dermatology conditions. The company completed its first human clinical study for AQST-108 in the first quarter of 2024, showing promising data. Further clinical studies are planned for the second half of 2024.

Commercial collaborations remain a strong focus for Aquestive. The company manufactured approximately 42 million doses in the first quarter of 2024, compared to 33 million doses in the same period in 2023. Royalty-based products like Sympazan® and Azstarys® continue to contribute to the company's revenue, alongside ongoing manufacturing and supply collaborations.

The company also successfully extended its cash runway into 2026 with the completion of a $77.5 million public offering, attracting high-quality institutional healthcare investors. The funds will be used to advance the development and commercialization of its product pipeline, including Anaphylm and Libervant, and for general corporate purposes.

Financially, research and development expenses increased to $5.9 million in the first quarter of 2024, up from $3.5 million in the same period of 2023, primarily due to the Anaphylm program. Selling, general, and administrative expenses also rose to $10.7 million, driven by one-time severance expenses, higher shared-based compensation, and increased personnel and consulting costs.

Aquestive reported a net loss of $12.8 million for the first quarter of 2024, compared to a net income of $8.1 million in the first quarter of 2023. This change was mainly due to increased expenses and the absence of a one-time $14.5 million income recognized in the first quarter of 2023. Non-GAAP adjusted EBITDA loss was $7.2 million, up from $3.9 million in the first quarter of the previous year.

Looking ahead, Aquestive's full-year 2024 financial guidance projects total revenue between $48 million and $51 million, with a non-GAAP adjusted EBITDA loss ranging from $22 million to $26 million.

In summary, Aquestive Therapeutics continues to make significant strides in advancing its product pipeline and securing regulatory approvals, while also enhancing its financial position through strategic public offerings and increased revenue from out-licensed products.