Aquestive(US:AQST)2025-11-05 21:04Financial Performance - Total revenues for Q3 2025 increased by $0.5 million, or 4%, year over year to $12.8 million, excluding one-time deferred revenue recognition from Q3 2024 [11]. - Total revenues for the three months ended September 30, 2025, were $12,807,000, a decrease of 5.4% compared to $13,542,000 for the same period in 2024 [45]. - Total costs and expenses for the three months ended September 30, 2025, were $24,286,000, an increase of 11.2% from $21,832,000 in 2024 [47]. - The net loss for Q3 2025 was $15.4 million, or $0.14 per share, compared to a net loss of $11.5 million, or $0.13 per share, in Q3 2024 [15]. - The net loss for the three months ended September 30, 2025, was $15,446,000, compared to a net loss of $11,509,000 for the same period in 2024, representing a 34.5% increase in loss [45]. - Non-GAAP adjusted EBITDA loss was $8.6 million in Q3 2025, compared to a loss of $6.6 million in Q3 2024 [16]. - Non-GAAP adjusted EBITDA for the three months ended September 30, 2025, was $(8,563,000), compared to $(6,554,000) for the same period in 2024 [46]. - The company reported a gross margin of 65% for the three months ended September 30, 2025, down from 67% in the same period of 2024 [47]. Revenue Sources - Manufacture and supply revenue rose to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, driven by increases in Sympazan and Suboxone revenues [12]. - Full-year 2025 total revenue guidance is projected between $44 million and $50 million [19]. Expenses - Research and development expenses decreased to $4.5 million in Q3 2025 from $5.3 million in Q3 2024, primarily due to lower clinical trial costs for Anaphylm [13]. - Selling, general and administrative expenses increased to $15.3 million in Q3 2025 from $12.1 million in Q3 2024, with a notable rise in commercial spending of approximately $1.8 million [14]. Cash and Assets - Cash and cash equivalents were $129.1 million as of September 30, 2025 [17]. - Cash and cash equivalents increased to $129,063,000 as of September 30, 2025, from $71,546,000 as of December 31, 2024 [43]. - Total assets as of September 30, 2025, were $163,559,000, up from $101,424,000 as of December 31, 2024 [43]. - Total current liabilities increased to $25,574,000 as of September 30, 2025, compared to $18,865,000 as of December 31, 2024 [43]. - The accumulated deficit increased to $(415,138,000) as of September 30, 2025, from $(363,214,000) as of December 31, 2024 [43]. Product Development and Strategy - The planned U.S. launch of Anaphylm is targeted for Q1 2026, pending FDA approval [7]. - The company is advancing its global expansion strategy, initiating regulatory engagement in Canada and the EU [6]. - Aquestive Therapeutics is advancing a late-stage proprietary product candidate, Anaphylm™, for the treatment of severe allergic reactions, including anaphylaxis [39]. - The company is focused on building commercial readiness for Anaphylm, pending FDA approval [39]. - The company is developing AQST-108, an epinephrine prodrug topical gel for dermatological conditions, including alopecia areata [34]. - The company anticipates potential international regulatory filings and market approvals for Anaphylm outside of the U.S. [39]. Risks and Challenges - Risks include potential delays in FDA approval processes for product candidates, including Anaphylm and Libervant [39]. - The company faces risks related to market acceptance and competition for its product candidates, should they receive FDA approval [40]. - The company is unable to predict with reasonable certainty the totality of adjustments for non-GAAP measures due to their dependence on future events [38]. Transparency and Reporting - Non-GAAP adjusted EBITDA loss and other non-GAAP measures are used to provide additional insight into the company's ongoing operating performance [36]. - The company emphasizes the importance of transparency in its financial results through the use of non-GAAP measures [37].