Aquestive Therapeutics Q2 2024 Financial Results and Business Update

Aquestive Therapeutics, Inc., a New Jersey-based pharmaceutical company, has released its financial results for the second quarter of 2024 and updated its business developments. The company, which specializes in innovative delivery technologies for medicines, is advancing several key pipeline programs and expanding the market reach of its existing products.

President and CEO Daniel Barber highlighted the company's progress, especially in developing their epinephrine prodrug platform. Aquestive's lead product candidate, Anaphylm™ (epinephrine) Sublingual Film, is poised to become the first orally administered epinephrine product for severe allergic reactions, including anaphylaxis. Barber emphasized Anaphylm's potential to significantly improve the management of severe allergic reactions and noted its billion-dollar commercial opportunity. The platform, branded as Adrenaverse™, is also expected to generate further product opportunities pending FDA approvals.

During the second quarter, Aquestive reported positive results from several studies on Anaphylm. A pharmacokinetic (PK) study in June 2024 demonstrated that Anaphylm's performance was consistent across various mouth conditions, regardless of the temperature or pH of water consumed prior to administration. Another study in July 2024 compared self-administration of Anaphylm to healthcare provider administration and manual intramuscular injection of Adrenalin. Results showed no significant differences in epinephrine exposure between self-administration and healthcare provider administration, with both achieving peak concentrations in 15 minutes, much faster than the 50-minute peak for intramuscular injection.

A final supportive study, the oral allergy syndrome (OAS) challenge, is expected to conclude by late third or early fourth quarter of 2024. Aquestive aims to submit a New Drug Application (NDA) for Anaphylm to the FDA in the first quarter of 2025, with a potential market launch by late 2025 or early 2026.

In addition to Anaphylm, Aquestive is developing AQST-108, an epinephrine prodrug topical gel for dermatological conditions. The company plans to meet with the FDA for a pre-Investigational New Drug (IND) application discussion by the fourth quarter of 2024 and initiate a phase 2a study in the first half of 2025.

Libervant™ (diazepam) Buccal Film, another significant product, received FDA approval in April 2024 for treating seizure clusters in children aged two to five. Aquestive plans to expand its sales team and distribution network in the third and fourth quarters of 2024, aiming for national retail availability. The company also intends to secure broader Medicaid and commercial coverage, crucial for this pediatric population.

Aquestive's commercial collaborations continue to thrive, with the company manufacturing 34 million doses in the second quarter of 2024, down from 48 million in 2023. The company supports global collaborations, including the European launch of Emylif® (Riluzole) Oral Film by Zambon, and continues to see demand for Indivior’s Suboxone® Sublingual Film.

Financially, Aquestive saw a 52% increase in total revenues to $20.1 million in the second quarter of 2024, up from $13.2 million in 2023. This growth was driven by increased license and royalty revenue, despite a decrease in manufacturing and supply revenue. Research and development expenses rose to $4.2 million, reflecting investments in the Anaphylm development program, while selling, general, and administrative expenses increased to $11.4 million.

The company reported a net loss of $2.7 million for the second quarter of 2024, significantly lower than the $5.8 million loss in the same period in 2023. Non-GAAP adjusted EBITDA income was $1.8 million, compared to a $3.3 million loss in 2023. Aquestive ended the quarter with cash and cash equivalents of $89.9 million and reaffirmed its cash runway into 2026.

Aquestive has updated its full-year 2024 financial guidance, now projecting total revenue of $57 to $60 million and a non-GAAP adjusted EBITDA loss of $20 to $23 million. The company will host a conference call to discuss these results and future plans.