Aquestive Therapeutics Sells Subsidiary for $30M

TL;DR

Aquestive selling off a subsidiary for $30M to focus on its own stuff. Big pharma buy.

AI Summary

Aquestive Therapeutics, Inc. announced on July 25, 2024, that it has entered into a definitive agreement to sell its subsidiary, Aquestive Pharma, LLC, to Amneal Pharmaceuticals LLC for $30 million. This transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions. The sale is part of Aquestive's strategy to focus on its proprietary products.

Why It Matters

This divestiture allows Aquestive Therapeutics to streamline its operations and concentrate resources on its core proprietary product pipeline, potentially accelerating future growth and innovation.

Risk Assessment

Risk Level: medium — The sale is subject to customary closing conditions, and the success of Aquestive's future strategy depends on the performance of its remaining proprietary products.

Key Numbers

• $30 million — Sale Price (Proceeds from the sale of Aquestive Pharma, LLC to Amneal Pharmaceuticals LLC.)

Key Players & Entities

• Aquestive Therapeutics, Inc. (company) — Seller
• Aquestive Pharma, LLC (company) — Subsidiary being sold
• Amneal Pharmaceuticals LLC (company) — Buyer
• $30 million (dollar_amount) — Sale price
• July 25, 2024 (date) — Announcement date
• fourth quarter of 2024 (date) — Expected closing period

FAQ

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share AQST Nasdaq Global Market I

Filing Documents

• aqst-20240725.htm (8-K) — 43KB
• aqst-selfadministrations.htm (EX-99.1) — 15KB
• aqst-20240725_g1.jpg (GRAPHIC) — 41KB
• aqst-selfadministrations001.jpg (GRAPHIC) — 125KB
• aqst-selfadministrations002.jpg (GRAPHIC) — 133KB
• aqst-selfadministrations003.jpg (GRAPHIC) — 148KB
• aqst-selfadministrations004.jpg (GRAPHIC) — 159KB
• aqst-selfadministrations005.jpg (GRAPHIC) — 164KB
• aqst-selfadministrations006.jpg (GRAPHIC) — 71KB
• 0001628280-24-032917.txt ( ) — 1394KB
• aqst-20240725.xsd (EX-101.SCH) — 2KB
• aqst-20240725_lab.xml (EX-101.LAB) — 21KB
• aqst-20240725_pre.xml (EX-101.PRE) — 12KB
• aqst-20240725_htm.xml (XML) — 3KB

01

Item 7.01 Regulation FD Disclosure. On July 25, 2024, Aquestive Therapeutics, Inc. (the "Company") issued a press release announcing positive topline pharmacokinetic (PK) data from the self-administration study of Anaphylm (epinephrine) Sublingual Film. Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the United States Food and Drug Administration (FDA). A copy of the Company's press release is attached as Exhibit 99.1 to this Current Report and incorporated in this Item 7.01 by reference. The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of, or otherwise subject to the liabilities of, Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

01

Item 8.01 Other Events. On July 25, 2024, the Company released positive topline PK data from the self-administration study of Anaphylm (epinephrine) Sublingual Film. Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the FDA. Topline PK Data from Self-Administration Study The single-dose, three-period, randomized crossover study design compared the PK and pharmacodynamics (PD) of Anaphylm self-administered, Anaphylm HCP administered, and Adrenalin manual intramuscular (IM) injection HCP administered. The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing in 36 healthy adult subjects. Graph 1 below provides a comparison of epinephrine concentration across the first 60 minutes post-administration. There was no statistical difference between the Anaphylm self-administered and HCP-administered arms of the study. The median time to maximum concentration (Tmax) was 15 minutes for both the Anaphylm self-administered and HCP-administered arms, while the median Tmax for the Adrenalin IM HCP administered arm was 50 minutes post administration. Graph 1: Baseline-Corrected Epinephrine Concentration Across Time*: (*Lines on the graph above represent the geometric means of baseline-corrected epinephrine concentration across study timepoints. Baseline-corrected values were calculated by subtracting from the mean of three pre-dose concentrations measured at 60-, 30- and 15-minutes prior to treatment administration.) The Company's remaining supportive study, the oral allergy syndrome (OAS) challenge study, is underway, and the study is expected to be completed late in the third quarter or early fourth quarter of 2024. The Company is maintaining its guidance on a full product launch of Anaphylm at the end of 2025

Forward-Looking Statements

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm (epinephrine) Sublingual Film through clinical development and approval by the FDA, including timing of expected supporting and pediatric clinical studies, request for a pre-NDA meeting in the third quarter 2024 and Aquestive's goals of filing an NDA for Anaphylm before the end of 2024 or early in 2025 and launching Anaphlym before the end of 2025 or in the first quarter of 2026, as well as the potential benefits Anaphylm could bring to patients. These forward-looking statements are based on the Company's current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with any delays or changes to the timing, cost and success of its product development activities and clinical trials for Anaphylm; risk of the Company's ability to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm; risk of the Company's ability to address the FDA's comments on the Company's pivotal PK study protocol and other concerns identified in the FDA Type C meeting minutes for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk of delays in

Financial Statements and Exhibits

Financial Statements and Exhibits (d)Exhibits. Exhibit Number Description 99.1 Press Release, dated July 25, 2024. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: July 25, 2024 Aquestive Therapeutics, Inc. By: /s/ A. Ernest Toth, Jr Name: A. Ernest Toth, Jr. Title: Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR