Aquestive(AQST) - 2025 Q2 - Quarterly Results

Aquestive Therapeutics Q2 2025 Business Update and Financial Results 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 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][4][7] - The company is advancing preparations for a potential U.S. launch of Anaphylm™ in the first quarter of 2026, contingent on FDA approval[3][5][7] - Aquestive is accelerating its global expansion strategy for Anaphylm™, with initial regulatory meetings planned in Canada and the European Union[3][5][7] Pipeline and Commercial Update Updates on Anaphylm™ commercial readiness, AQST-108 IND submission, Libervant® relaunch, and stable manufacturing collaborations highlight pipeline and commercial progress Anaphylm™ (epinephrine) Sublingual Film 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] - The clinical program for Anaphylm™ includes 10 completed studies with approximately 935 total administrations across 379 subjects[4] - 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] AQST-108 (epinephrine) Topical Gel 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] - 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] Libervant® (diazepam) Buccal Film 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] - The company remains committed to relaunching Libervant in 2027 or sooner, should it receive full marketing approval from the FDA[9] Commercial Collaborations 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] - The company's U.S.-based supply chain is confirmed to be largely unaffected by both implemented and proposed tariffs, ensuring production stability[10] Second Quarter 2025 Financial Performance 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] - 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][14] 2025 Financial Outlook 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 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] - Libervant® (diazepam) Buccal Film is administered inside the cheek for the acute treatment of seizure clusters in epilepsy patients[24] - AQST-108 (epinephrine) Topical Gel is a topically delivered adrenergic agonist prodrug gel product candidate based on the company's AdrenaVerse™ platform[26] Disclosures and Financial Statements 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 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] - 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] - The most common side effects of Libervant are listed as sleepiness and headache[35] About Aquestive Therapeutics, Inc. 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] - The company has four licensed commercialized products marketed by licensees and serves as the exclusive manufacturer for them[34] Non-GAAP Financial Information 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] - Management believes these non-GAAP measures provide added transparency into the company's operating performance and the effectiveness of its strategies[39] Forward-Looking Statement 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] - 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] Financial Statements (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 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 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 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 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 |