By The Life Science Report

Source: Streetwise Reports   11/06/2019

Aquestive Therapeutics shares traded 20% higher today after the firm reported Q3/19 earnings and raised its FY/19 guidance. The firm states it expects to complete its NDA for Libervant buccal film near the end of this month.

Yesterday afternoon, specialty pharmaceutical company Aquestive Therapeutics Inc. (AQST:NASDAQ), which focuses on the development and commercialization of differentiated products in order to meet unmet patient needs and solve therapeutic problems, reported third quarter financial results for the period ending September 30, 2019. In the release, the company also provided an update on recent business and pipeline developments.

Aquestive’s CEO Keith J. Kendall commented, “The third quarter was an important one in our evolution. We successfully completed the crossover study requested by the U.S. Food and Drug Administration (FDA) for Libervant compared to the reference listed rectal gel. We also completed our proof-of-concept study for epinephrine, AQST-108, for the treatment of allergic reactions including anaphylaxis, and requested a pre-IND meeting with the FDA. In addition, we advanced the commercialization of Sympazan with more than 50% growth of shipments to retailers since the end of the second quarter.”

In the report the company stated that it is “building a portfolio of differentiated medicines that can offer physicians and patients, who have difficulty using currently available treatment options, improved clinical and usability features based on the Company’s PharmFilm technology.”

The firm advised that “Aquestive is expected to complete its rolling NDA submission for Libervant (diazepam) Buccal Film around the end of November 2019, after having filed the CMC portion in September 2019. Libervant has the potential to be the first oral therapy approved by the FDA for the management of seizure clusters in the population of 1.2 million refractory epilepsy patients and the first diazepam based treatment usable by and delivering a consistent predictable dose to virtually all patients to whom it is prescribed.”

The company further noted that “positive data reported from Phase 1 dose escalation proof-of-concept study in healthy subjects for AQST-108, a “first in class” oral sublingual film formulation of epinephrine, demonstrated the ability to deliver systemic epinephrine using Aquestive’s proprietary PharmFilm formulation.”

In addition, the firm pointed out that the “adoption of Sympazan (clobazam) oral film for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) continues to grow, with shipments to retailers increasing over 50% as compared to the quarter ended in June.”

The company reported that total revenues were $12.4 million in Q3/19, compared to $13.3 million in Q2/18. The firm advised that as expected the year-over-year decrease reflected lower license and royalty revenue in 2019.

Aquestive’s reported a net loss for Q3/19 of $18.4 million, or $0.74 loss per share compared to a net loss of $15.0 million, or $0.64 loss per share in Q3/18. The firm advised that “the year-over-year change in net loss was driven primarily by higher investments in 2019 in the commercialization of Sympazan, and in the development of Libervant and AQST-108.” The company listed that as of Cash and cash equivalents as of September 30, 2019 were $20.9 million.

The company noted that it is raising its full-year 2019 revenue and earnings guidance and updating its financial outlook for 2019. Aquestive indicated that for FY/19, it expects “total revenues of $45-47 million; Non-GAAP gross margins of 67-69%; Non-GAAP adjusted EBITDA loss of $49-50 million; and Cash burn of approximately $60-65 million.”

Aquestive Therapeutics is headquartered in Warren, N.J., and is a specialty pharmaceutical company focused on the development of treatments for diseases related to the central nervous system (CNS). The firm’s CNS product pipeline includes Libervant, a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures, and Sympazan, an oral soluble film formulation of clobazam for the treatment of seizures associated with a rare, intractable form of epilepsy known as Lennox-Gastaut Syndrome. The company also has complex molecule programs used in the treatment of anaphylaxis and neuroendocrine tumors, and the firm also has a pipeline of products under partner programs for treatment of opioid dependence and Parkinson’s disease.

Aquestive Therapeutics has a market capitalization of around $105.9 million with approximately 25 million shares outstanding. AQST shares opened slightly higher today at $4.33 (+$0.10, +2.36%) over yesterday’s $4.23 closing price. The stock has traded today between $4.33 and $5.74/share and is currently trading at $5.10 (+$0.87, +20.57%).

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