[Aquestive Therapeutics Q2 2025 Business Update and Financial Results](index=1&type=section&id=Aquestive%20Therapeutics%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) Aquestive Therapeutics provides a comprehensive update on its Q2 2025 business performance, strategic advancements, and financial results, highlighting key pipeline progress and future outlook [Business and Strategic Highlights](index=1&type=section&id=Business%20and%20Strategic%20Highlights) Aquestive Therapeutics advanced Anaphylm™ with FDA NDA acceptance, preparing for a 2026 U.S. launch and initiating global expansion efforts - The FDA has accepted the New Drug Application (NDA) for **Anaphylm™**, the company's oral, sublingual film epinephrine product, and has set a PDUFA target action date of **January 31, 2026**[3](index=3&type=chunk)[4](index=4&type=chunk)[7](index=7&type=chunk) - The company is advancing preparations for a potential **U.S. launch of Anaphylm™ in the first quarter of 2026**, contingent on FDA approval[3](index=3&type=chunk)[5](index=5&type=chunk)[7](index=7&type=chunk) - Aquestive is accelerating its **global expansion strategy** for Anaphylm™, with initial regulatory meetings planned in Canada and the European Union[3](index=3&type=chunk)[5](index=5&type=chunk)[7](index=7&type=chunk) [Pipeline and Commercial Update](index=1&type=section&id=Pipeline%20and%20Commercial%20Update) Updates on Anaphylm™ commercial readiness, AQST-108 IND submission, Libervant® relaunch, and stable manufacturing collaborations highlight pipeline and commercial progress [Anaphylm™ (epinephrine) Sublingual Film](index=1&type=section&id=Anaphylm%E2%84%A2%20(epinephrine)%20Sublingual%20Film) The Anaphylm™ program is advancing with FDA NDA acceptance, ongoing review, and preparations for a potential Advisory Committee meeting - The **FDA accepted the NDA for Anaphylm™** and is initiating its review, with preparations ongoing for a possible Advisory Committee meeting ahead of the **January 31, 2026 PDUFA date**[4](index=4&type=chunk) - The clinical program for Anaphylm™ includes **10 completed studies** with approximately **935 total administrations** across **379 subjects**[4](index=4&type=chunk) - Anaphylm™ is positioned as an **orally administered, non-device product** with a **pharmacokinetic profile comparable to leading injectables**, aiming to address barriers like fear of needles and device complexity[6](index=6&type=chunk) [AQST-108 (epinephrine) Topical Gel](index=2&type=section&id=AQST-108%20(epinephrine)%20Topical%20Gel) AQST-108 is progressing towards an IND submission in late 2025 as a potential topical treatment for alopecia areata - Aquestive anticipates submitting an **Investigational New Drug (IND) Application for AQST-108** for the treatment of alopecia areata (AA) to the FDA in the **fourth quarter of 2025**[8](index=8&type=chunk) - AQST-108 is being developed as a **potential topical treatment for AA**, which could offer an alternative to systemic JAK inhibitors that have known side effects and "black box" warnings[8](index=8&type=chunk) [Libervant® (diazepam) Buccal Film](index=2&type=section&id=Libervant%C2%AE%20(diazepam)%20Buccal%20Film) Libervant® faces a temporary regulatory hurdle due to orphan drug exclusivity, with a relaunch targeted for 2027 or sooner upon full approval - Libervant's regulatory status was revised from full to **tentative approval** due to a court decision related to another drug's **orphan drug exclusivity**, a change not related to the product's safety or efficacy[9](index=9&type=chunk) - The company remains committed to **relaunching Libervant in 2027 or sooner**, should it receive full marketing approval from the FDA[9](index=9&type=chunk) [Commercial Collaborations](index=2&type=section&id=Commercial%20Collaborations) Manufacturing collaborations provide steady revenue, offsetting Suboxone's decline with growth from newer products, and the U.S. supply chain remains stable - The company's **manufacturing business remains steady**, with the **gradual decline of Suboxone** being offset by **growth from newer collaborations** for products like Sympazan, Ondif, and Emylif[10](index=10&type=chunk) - The company's **U.S.-based supply chain** is confirmed to be **largely unaffected by both implemented and proposed tariffs**, ensuring production stability[10](index=10&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financials) Aquestive reported **$10.0 million** in Q2 2025 revenues, a **3% increase** excluding a prior-year one-time item, with a net loss of **$13.5 million** and **$60.5 million** in cash Q2 2025 Financial Summary | Financial Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenues | $10.0 | $20.1 | -50.2% | | Revenue (ex. one-time item) | $10.0 | $9.7 | +3% | | Net Loss | ($13.5) | ($2.7) | Increased Loss | | Loss Per Share (Basic & Diluted) | ($0.14) | ($0.03) | Increased Loss | | Non-GAAP Adjusted EBITDA | ($9.3) | $1.8 | Decreased | | Cash and Cash Equivalents | $60.5 | N/A | N/A | - The significant **year-over-year decrease in total revenues** was primarily due to a **one-time recognition of deferred revenue** in Q2 2024 from terminated agreements, with revenues **grew by $0.3 million** excluding this impact[11](index=11&type=chunk) - Selling, general and administrative (SG&A) expenses **increased to $12.7 million from $11.4 million** in Q2 2024, mainly due to higher commercial spending, regulatory fees, and personnel costs, partially offset by lower legal fees[13](index=13&type=chunk)[14](index=14&type=chunk) [2025 Financial Outlook](index=3&type=section&id=2025%20Outlook) Aquestive has provided its financial guidance for the full year of 2025, anticipating total revenues between **$44 million and $50 million** and a non-GAAP adjusted EBITDA loss of **$47 million to $51 million** 2025 Full-Year Financial Guidance | Guidance Metric | 2025 Full-Year Outlook (in millions) | | :--- | :--- | | Total Revenue | $44 to $50 | | Non-GAAP Adjusted EBITDA Loss | $47 to $51 | [About Our Products](index=3&type=section&id=About%20Our%20Products) This section describes the company's key product candidates: Anaphylm™ for epinephrine delivery, Libervant® for acute seizures, and AQST-108 for dermatological conditions - **Anaphylm™ (epinephrine) Sublingual Film** is a polymer matrix-based epinephrine prodrug candidate, similar in size to a postage stamp, that dissolves on contact without water[23](index=23&type=chunk) - **Libervant® (diazepam) Buccal Film** is administered inside the cheek for the acute treatment of seizure clusters in epilepsy patients[24](index=24&type=chunk) - **AQST-108 (epinephrine) Topical Gel** is a topically delivered adrenergic agonist prodrug gel product candidate based on the company's AdrenaVerse™ platform[26](index=26&type=chunk) [Disclosures and Financial Statements](index=4&type=section&id=Disclosures%20and%20Financial%20Statements) This section provides essential disclosures, including product safety information, company overview, non-GAAP financial explanations, forward-looking statements, and detailed unaudited financial statements [Important Safety Information](index=4&type=section&id=Important%20Safety%20Information) This section outlines critical safety warnings for Libervant®, including risks with opioids, potential for abuse, dependence, and common side effects like sleepiness - A key warning states that taking benzodiazepines like Libervant with opioids, alcohol, or other CNS depressants can cause **severe drowsiness, respiratory depression, coma, and death**[30](index=30&type=chunk) - The information outlines the **risk of abuse, misuse, and addiction**, as well as **physical dependence and withdrawal reactions**, emphasizing that Libervant is not intended for daily use[30](index=30&type=chunk) - The most common side effects of Libervant are listed as **sleepiness and headache**[35](index=35&type=chunk) [About Aquestive Therapeutics, Inc.](index=5&type=section&id=About%20Aquestive%20Therapeutics%2C%20Inc.) Aquestive Therapeutics develops orally administered products, has four licensed commercialized products, and is advancing late-stage Anaphylm™ and early-stage AQST-108 candidates - Aquestive develops **orally administered products** to provide novel alternatives to invasive and inconvenient standard of care therapies[34](index=34&type=chunk) - The company has **four licensed commercialized products** marketed by licensees and serves as the exclusive manufacturer for them[34](index=34&type=chunk) [Non-GAAP Financial Information](index=7&type=section&id=Non-GAAP%20Financial%20Information) This section explains the company's use of non-GAAP financial measures, such as adjusted EBITDA loss and other adjusted expenses, to analyze operating performance by excluding certain non-cash or non-recurring items - The company uses non-GAAP measures like **adjusted EBITDA loss**, which exclude items such as **share-based compensation, interest expense, depreciation, amortization, and income taxes**[37](index=37&type=chunk) - Management believes these non-GAAP measures provide **added transparency** into the company's operating performance and the effectiveness of its strategies[39](index=39&type=chunk) [Forward-Looking Statement](index=8&type=section&id=Forward-Looking%20Statement) This section contains the company's safe harbor statement, cautioning that forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially - Forward-looking statements include those regarding the advancement and timing of **Anaphylm™ and AQST-108** through clinical development and FDA approval[41](index=41&type=chunk) - The company outlines significant risks, such as **delays in the FDA approval process**, the ability to generate **sufficient clinical data**, **competition**, and the need for **sufficient capital resources**[42](index=42&type=chunk) [Financial Statements (Unaudited)](index=10&type=section&id=Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements for the period ended June 30, 2025, including balance sheets, statements of operations, and non-GAAP reconciliations [Condensed Balance Sheets](index=10&type=section&id=Condensed%20Balance%20Sheets) This table presents the company's condensed balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' deficit | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $60,536 | $71,546 | | Total current assets | $81,721 | $88,220 | | Total assets | $93,698 | $101,424 | | Total current liabilities | $23,155 | $18,865 | | Total liabilities | $166,288 | $161,580 | | Total stockholders' deficit | ($72,590) | ($60,156) | [Condensed Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This table presents the condensed statements of operations and comprehensive loss for the three months ended June 30, 2025 and 2024 | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $10,003 | $20,099 | | Total costs and expenses | $21,371 | $20,044 | | Loss from operations | ($11,368) | $55 | | Net loss | ($13,548) | ($2,745) | | Loss per share (basic and diluted) | ($0.14) | ($0.03) | [Reconciliation of Net Loss to Non-GAAP Adjusted EBITDA](index=12&type=section&id=Reconciliation%20of%20Non-GAAP%20Adjustments%20-%20Net%20Loss%20to%20Non-GAAP%20Adjusted%20EBITDA) This table reconciles GAAP net loss to non-GAAP adjusted EBITDA for the three months ended June 30, 2025 and 2024 | Reconciliation to Adj. EBITDA (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP net loss | ($13,548) | ($2,745) | | Total non-GAAP adjustments | $4,204 | $4,544 | | Non-GAAP adjusted EBITDA | ($9,344) | $1,799 | [Reconciliation of GAAP Expenses to Non-GAAP Adjusted Expenses](index=13&type=section&id=Reconciliation%20of%20Non-GAAP%20Adjustments%20-%20GAAP%20Expenses%20to%20Non-GAAP%20Adjusted%20Expenses) This table reconciles GAAP expenses to non-GAAP adjusted expenses for the three months ended June 30, 2025 and 2024 | Expense Reconciliation (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP Total costs and expenses | $21,371 | $20,044 | | Non-GAAP adjusted costs and expenses | $19,347 | $18,300 | | GAAP R&D Expense | $4,105 | $4,162 | | Non-GAAP adjusted R&D expense | $3,681 | $3,836 | | GAAP SG&A Expenses | $12,705 | $11,356 | | Non-GAAP adjusted SG&A expenses | $11,345 | $10,213 |

Core Insights - Aquestive Therapeutics announced pivotal progress with the FDA's acceptance of the NDA for Anaphylm, which could become the first oral, sublingual film epinephrine product if approved [2][3] - The company is preparing for a potential U.S. launch in 2026 and is also engaging in regulatory discussions for global expansion in Canada and the EU [2][4] - Financial results for Q2 2025 showed total revenues of $10.0 million, a decrease from $20.1 million in Q2 2024, primarily due to the prior year's one-time revenue recognition [11][14] Regulatory and Product Development - The FDA has accepted the NDA for Anaphylm, with a PDUFA date set for January 31, 2026, and the company is preparing for an Advisory Committee meeting [3][7] - Anaphylm has completed 10 clinical studies with approximately 935 administrations across 379 subjects, addressing the unmet need for non-invasive epinephrine delivery options [3][5] - The company is also advancing AQST-108, a topical gel for alopecia areata, with an anticipated IND submission in Q4 2025 [6] Commercial Strategy - Aquestive is building a commercial launch team for Anaphylm and leveraging existing infrastructure for execution [4] - The company views international markets as critical for long-term strategy and is actively pursuing regulatory meetings in Canada and the EU [4][5] - Anaphylm is positioned to address barriers to epinephrine adoption, such as fear of needles and device complexity, potentially transforming emergency allergy treatment [5] Financial Performance - Total revenues for Q2 2025 increased by $0.3 million, or 3%, year-over-year, excluding the impact of one-time deferred revenue recognition [11] - Manufacturing and supply revenue rose to $9.6 million in Q2 2025 from $8.1 million in Q2 2024, driven by increased Ondif revenues [12] - The net loss for Q2 2025 was $13.5 million, compared to a net loss of $2.7 million in Q2 2024, primarily due to decreased revenues and increased administrative expenses [14][15] Future Outlook - The company expects total revenue for the full year 2025 to be between $44 million and $50 million, with a non-GAAP adjusted EBITDA loss projected between $47 million and $51 million [17] - Cash and cash equivalents were reported at $60.5 million as of June 30, 2025, indicating a stable financial position for ongoing operations [16]

Company Overview - Aquestive Therapeutics is a publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines through innovative science and delivery technologies[7] - The company has shipped over 25 billion PharmFilm doses worldwide[10] - Aquestive Therapeutics reported over $57 million in revenue in 2024[13, 14] - The company anticipates 2 product launches in the U S by 2027[17] - The company estimates over $15 billion in potential peak annual net sales from pipeline assets[18] Anaphylm (epinephrine) Sublingual Film - The U S epinephrine market has the potential to grow to approximately $2 billion in value by 2031[54] - The current market size in 2024 is approximately $800 million[55] - The epinephrine market has experienced a 15% CAGR from 2021 to 2023[55, 56] - 95% of patients are interested in a film-dosing option for epinephrine[66] - The PDUFA action date for Anaphylm is scheduled for January 31, 2026[27, 69] AQST-108 (epinephrine) Topical Gel - The company is pursuing alopecia areata (AA) as a potential initial indication for AQST-108[75] - The market opportunity for JAK inhibitors for alopecia areata is estimated at over $1 billion[80]

Core Viewpoint - Aquestive Therapeutics, Inc. is set to report its second quarter results for the period ending June 30, 2025, and will provide updates on recent business developments on August 11, 2025 [1]. Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [3]. - The company is developing orally administered products to deliver complex molecules, offering alternatives to invasive and inconvenient standard therapies [3]. - Currently, Aquestive has four commercialized products marketed by its licensees in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [3]. - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies, such as PharmFilm® [3]. - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an earlier-stage epinephrine prodrug topical gel for various dermatological conditions, including alopecia areata [3]. Upcoming Events - Management will host a conference call for investors on August 12, 2025, at 8:00 a.m. ET, with registration required for participation [2]. - A live webcast of the call will be available on the Investors section of the company's website, and a replay will be archived for 30 days [2].

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [4] - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive therapies [4] - Currently, Aquestive has four commercialized products marketed by its licensees and collaborates with other pharmaceutical companies to bring new molecules to market [4] Leadership Change - Sherry Korczynski has been promoted from Senior Vice President of Sales and Marketing to Chief Commercial Officer effective July 22, 2025 [1] - Her promotion is attributed to her exceptional track record in commercial leadership, particularly in the allergy market, and her strategic oversight of the EpiPen brand at Mylan [2] - Korczynski joined Aquestive in February 2024 and has over two decades of experience in commercial and launch roles across various pharmaceutical companies [2] Product Development - Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate that is designed to be the first and only device-free, orally delivered epinephrine product [3] - The product is small, weighing less than an ounce, and dissolves on contact without the need for water or swallowing [3] - Anaphylm has been conditionally approved by the U.S. Food and Drug Administration (FDA), with final approval dependent on the product candidate's approval [3] Market Positioning - Anaphylm is positioned to potentially redefine anaphylaxis care, with a focus on successful launch and delivery to patients in the U.S. and abroad [3] - The company aims to leverage Korczynski's deep market knowledge and experience to drive its global commercial strategy for Anaphylm [2]

Core Viewpoint - Aquestive Therapeutics is advancing its regulatory strategy for Anaphylm™ (epinephrine) Sublingual Film, with meetings scheduled with Health Canada and the European Medicines Agency, aiming to provide a needle-free treatment option for anaphylaxis [1][2][4]. Regulatory Strategy - The company has received a meeting with Health Canada to discuss its New Drug Submission for Anaphylm™ and has submitted an initial briefing book to the EMA [1][8]. - A Marketing Authorization Application (MAA) is planned for submission to the EMA as soon as possible [1][2]. Product Overview - Anaphylm™ is an orally administered epinephrine product that addresses issues related to traditional auto-injectors, such as needle phobia and device malfunctions [3][6]. - The product is designed to be portable, weather-resistant, and easy to use, requiring no water or swallowing for administration [6]. Market Focus - The company's ex-U.S. regulatory strategy targets markets with significant unmet medical needs, with Canada and the EMA being prioritized due to their supportive regulatory environments [4][5]. - The company aims to establish Anaphylm as the new standard of care for severe allergic reactions and anaphylaxis globally [5]. Company Background - Aquestive Therapeutics has a portfolio of six FDA-approved drugs and a global presence across six continents, which enhances its ability to navigate international regulatory processes [2][7]. - The company is also developing other product candidates, including a topical gel for dermatological conditions [7].

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [2] - The company develops orally administered and topical gel products to deliver complex molecules, providing alternatives to invasive standard therapies [2] - Currently, Aquestive has four commercialized products marketed by its licensees in the U.S. and globally, and it is the exclusive manufacturer of these products [2] Product Development - The company is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis [2] - An early-stage epinephrine prodrug topical gel product candidate is also in development for various dermatological conditions, including alopecia areata [2] Upcoming Events - The management team of Aquestive will participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 9, 2025, which will include panels on key therapeutic themes in immunology, inflammation, and metabolism [1]

Core Insights - The article discusses the performance and future outlook of Aquestive Therapeutics (NASDAQ: AQST), noting a 2% decline in the stock price over the past six months since the last analysis [2]. Company Focus Areas - The company is focusing on five key areas for 2025, including the potential FDA approval of Anaphylm, which is a significant catalyst for future growth [2]. Investment Group Features - The investment group Compounding Healthcare offers several features such as model healthcare portfolios, a weekly newsletter, a daily watchlist, and a platform for dialogue and questions among members [2].

Core Insights - Aquestive Therapeutics, Inc. announced two poster presentations on Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit, highlighting its potential as the first orally delivered epinephrine option for severe allergic reactions in the U.S. [1] Group 1: Product Details - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is small, lightweight, and dissolves on contact without the need for water or swallowing [3] - The product's packaging is designed to be portable and weather-resistant, making it convenient for users [3] - Anaphylm has received conditional approval for its trade name from the FDA, pending final product approval [3] Group 2: Presentation Information - The first poster presentation focuses on the physicochemical properties of Anaphylm under extreme temperatures and real-world conditions, led by Nils Confer, PhD [2] - The second poster presentation discusses the pharmacokinetic and pharmacodynamic responses of Anaphylm, led by Carl Kraus, MD [2] Group 3: Company Overview - Aquestive Therapeutics is dedicated to advancing medicines through innovative science and delivery technologies, with a focus on orally administered products [4] - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market [4] - In addition to Anaphylm, the company is developing an earlier-stage epinephrine prodrug topical gel for dermatological conditions [4]

FDA assigns PDUFA target action date of January 31, 2026 Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/o ...