Part 1: Analysis of Performance

Aquestive Therapeutics, Inc. reported its Q2 2022 financial results, and the company's total revenues were $11.1 million, an increase of 61% from the same quarter in the prior year. The company had a net loss of $11.3 million, or ($0.29) per share, compared to a net loss of $9.2 million, or ($0.30) per share, in the same quarter of 2021. The significant increase in revenue was driven by strong product sales, including Suboxone, the company's largest product by revenue. The overall gross margin also increased from 51.7% to 73.2%, indicating improvements in the company's operating efficiency.

The company also reported progress in its clinical trial programs, particularly for AQST-109, a drug candidate for the treatment of ulcerative colitis. The drug achieved its primary endpoint and demonstrated statistically significant improvements in clinical remission rates compared to a placebo group. AQST-109 has been granted Fast Track designation by the FDA, which could expedite its approval process in the future.

Moreover, as per the company's CEO, the strong financial performance, expanding portfolio, and recent clinical trial successes demonstrate that the company is delivering on its strategic priorities of developing innovative treatments for underserved patient populations, growing its product portfolio, and pursuing partnerships and collaborations.

Part 2: Forward-Looking Analysis

Aquestive Therapeutics remains focused on advancing its current clinical trial programs and expanding its product portfolio. The company's pipeline includes several drug candidates at various stages of development and regulatory approval, such as AQST-108 for the treatment of severe migraines, AQST-305 for the treatment of epilepsy, and AQST-119 for the treatment of ALS.

The company faces competition in its industry from both established pharmaceutical companies and emerging biotech companies. Additionally, the ongoing COVID-19 pandemic poses potential risks to the company's operations and supply chain.

Although the company's recent clinical trial results are promising, further regulatory approvals and commercialization of its products are not guaranteed. The future financial performance of the company will depend on several factors, including the successful commercialization of its product portfolio, the company's ability to secure sufficient capital resources to fund its operations, and the overall market trends and demand for its products.

In summary, Aquestive Therapeutics, Inc. has reported a strong financial performance and promising clinical trial results in recent quarters. The company continues to focus on developing innovative treatments and expanding its product portfolio while navigating the challenges posed by competition and the COVID-19 pandemic. Investors should carefully monitor the progress of the company's clinical trial programs and ongoing financial performance to assess the viability of their investment.

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Aquestive Therapeutics Inc

Aquestive Therapeutics' Q2 2022 Report: Revenue up 61%, Achieved Primary Endpoint in Ulcerative Colitis Clinical Trial.

Form 8-K - Current report - Item 2.02 Item 7.01 Item 9.01

Announcement: AQST 8-K Special Filing

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Part 1: Analysis of the Performance of Aquestive Therapeutics, Inc.

Aquestive Therapeutics, Inc. is a pharmaceutical company that focuses on developing medicines to address patients’ problems with current standards of care. The company earns revenues through the manufacture and supply of products made to order for licensees, co-development and research fees, licensing of intellectual property, and proprietary product sales. 

During the period under review, Aquestive Therapeutics had revenue of $56.7 million. This figure is a substantial improvement of 89% from the $30 million revenue recorded in the previous year. The revenue growth was due to the increase in manufacture and supply revenue and license and royalty revenue. There was also an increase in proprietary product sales, which were recorded as a net value.

The company's manufacture and supply revenue category, which accounts for the bulk of its revenue, saw a growth of 24% compared to the previous year. The growth in this category was driven by growth in purchases made by existing licensees and new purchase orders initiated by recently-signed licensees.

Additionally, the co-development and research fee category, which is generated through performing specific developmental tasks, also witnessed growth during this period. This was due to the successful completion of certain contractually defined activities with its licensee partners.

Furthermore, the company recorded remarkable progress in its intellectual property (IP) licensing and royalty revenue category. Royalties earned in this category are based on sales of products that use the company's patented technology. The increase in this category can be attributed to the increase in sales of licensed products in multiple markets.

Part 2: Forward-looking Analysis of Aquestive Therapeutics, Inc.

Aquestive Therapeutics is well-positioned to benefit from a growing pharmaceutical sector. The company's product pipeline for the treatment of severe allergic reactions, including anaphylaxis, and diseases of the central nervous system (CNS) places it at the forefront of introducing transformative products to improve patients' lives.

The global COVID-19 pandemic remains a major challenge. The extent of its impact on the company's operations, financial performance, clinical trials, regulatory approval process, and capital and financial markets remains uncertain. However, the company has thus far been able to continue manufacturing and supplying its products while monitoring customer demand and market conditions.

Looking forward, Aquestive Therapeutics expects to generate future manufacture and supply revenue by meeting the volume demands of existing licensed products and by having manufacturing and supply rights under new successful product development collaborations. Additionally, the company is seeking to increase royalty revenue through the licensing of its intellectual property to companies developing similar products.

Aquestive's management team remains optimistic about the future prospects of the company. According to Keith J. Kendall, the company's Chief Executive Officer, “We are confident in our ability to advance transformative therapeutic options for patients and drive value for all our stakeholders." 

Overall, Aquestive Therapeutics has strong prospects for growth, driven by its licensees' continuing demand for manufactured products, co-development of pharmaceutical products, and ongoing proprietary product sales. Additionally, the company's development pipeline for the treatment of severe allergic reactions, including anaphylaxis, and diseases of the central nervous system, of which some are late-stage, offer further prospects for growth in the years ahead.

Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

Aquestive Therapeutics Sees 89% Revenue Growth: Analyst Report.

Form 8-K - Current report - Item 7.01 Item 9.01