Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe

TICKERS: AQST

Aquestive Therapeutics Shares Up on Pipeline Update and Raised Full-Year 2019 Guidance

Share on Stocktwits

Source:

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%).

[NLINSERT]

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.





Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Life Sciences Report Newsletter Free and be the first to know!

A valid email address is required to subscribe