Anaphylm (dibutepinephrine) Sublingual Film - The FDA confirmed that it will not require an Advisory Committee to review the Company's New Drug Application for Anaphylm[8] - The company is preparing for a U S launch in Q1 2026, if approved by the FDA[8] - The company broadened the patent estate for Anaphylm with the issuance of two new patents, extending patent protection into 2037[8] AQST-108 and AdrenaVerse Platform - The company plans to open Investigational New Drug application for AQST-108 with FDA in Q4 2025[11] - The company expects to initiate a clinical study for AQST-108 for Alopecia Areata in 1H 2026[11] Financial Position - The company successfully completed an equity raise of $85 million in August 2025[11] - The company also completed a strategic financing for $75 million with RTW Investments, LP, subject to FDA approval of Anaphylm and refinancing of the Company's existing debt[11] - The company's ending cash balance in Q3 2025 was $129.1 million[17] - The company expects to meet near-term milestones with projected cash runway into 2027[16] - The company's 2025 outlook includes total revenues of approximately $44-$50 million and a non-GAAP adjusted EBITDA loss of approximately $47-$51 million[23]

Core Insights - Aquestive Therapeutics reported a revenue of $12.81 million for the quarter ended September 2025, reflecting a decrease of 5.4% year-over-year and a revenue surprise of -4.13% compared to the Zacks Consensus Estimate of $13.36 million [1] - The company's EPS was -$0.14, slightly worse than the -$0.13 EPS from the same quarter last year, resulting in an EPS surprise of -7.69% against the consensus estimate [1] Revenue Breakdown - Manufacture and supply revenue was reported at $11.47 million, exceeding the average estimate of $10.48 million by four analysts, and showing a year-over-year increase of 7.5% [4] - Co-development and research fees amounted to $0.3 million, falling short of the three-analyst average estimate of $0.53 million, representing a significant year-over-year decline of 38.6% [4] - License and royalty revenue was reported at $1.04 million, which is below the three-analyst average estimate of $2.3 million, indicating a year-over-year decrease of 52% [4] Stock Performance - Over the past month, shares of Aquestive Therapeutics have returned +1.8%, outperforming the Zacks S&P 500 composite's +1% change [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for outperformance in the near term [3]

Company Performance - Aquestive Therapeutics reported a quarterly loss of $0.14 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.13, representing an earnings surprise of -7.69% [1] - The company posted revenues of $12.81 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 4.13% and down from $13.54 million a year ago [2] - Over the last four quarters, the company has only surpassed consensus EPS estimates once and has not beaten consensus revenue estimates [2] Stock Movement and Outlook - The stock has increased approximately 70.8% since the beginning of the year, significantly outperforming the S&P 500's gain of 15.1% [3] - The future price movement of the stock will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.14 on revenues of $14.03 million, and for the current fiscal year, it is -$0.63 on revenues of $46.1 million [7] Industry Context - The Medical - Drugs industry, to which Aquestive Therapeutics belongs, is currently in the top 40% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Product Development - Anaphylm™ (dibutepinephrine) Sublingual Film is being developed as the first non-device based, orally delivered epinephrine product candidate, showing clinical results comparable to auto-injectors for treating anaphylaxis [167]. - In March 2024, the pivotal clinical study for Anaphylm met its primary endpoint of epinephrine PK biocomparability with IM injection and autoinjectors, demonstrating safety and tolerability [173]. - The pivotal clinical study commenced in Q4 2023, incorporating FDA feedback on protocol design, sample size, and statistical analysis [171]. - Positive topline data from a temperature/pH study of Anaphylm showed no statistically significant difference in PK and PD results based on temperature and pH variability [174]. - In October 2024, positive topline data from the OASIS study showed a median time to complete symptom resolution of 12 minutes post-Anaphylm administration, compared to 74 minutes at screening baseline [177]. - The pediatric study for Anaphylm, involving 32 patients aged 7 to 17, reported consistent PK results with previous adult studies and no serious adverse events [180]. - Anaphylm's PK profile showed median Tmax maintained at 12 minutes, with rapid symptom resolution observed in 94% of subjects after allergen exposure [177]. - The company is focused on addressing large market opportunities with its complex molecule pipeline, including the Anaphylm and Adrenaverse™ platforms [167]. Regulatory Approvals - The FDA granted Fast Track designation for Anaphylm in March 2022, and the 505(b)(2) regulatory approval pathway was confirmed as acceptable [169]. - The FDA accepted the NDA submission for Anaphylm on June 16, 2025, with a PDUFA target action date of January 31, 2026 [181]. - The FDA confirmed that an advisory committee meeting would not be required for Anaphylm, streamlining the approval process [182]. - The company received positive pre-NDA feedback from the FDA, indicating no additional adult clinical trials would be necessary for the NDA submission [179]. - The company is pursuing regulatory strategies for Anaphylm outside the United States, including discussions with Health Canada and the EMA [181]. Financial Performance - The company generated $31,530 and $45,694 in revenue from its licensed product portfolio for the nine months ended September 30, 2025, and 2024, respectively [191]. - Total revenues for the three months ended September 30, 2025, decreased by 5%, or $735, compared to the same period in 2024, primarily due to decreases in license and royalty revenue [223]. - Manufacture and supply revenue increased by approximately 7%, or $796, for the three months ended September 30, 2025, driven by a $395 increase in Sympazan revenues and a $380 increase in Suboxone revenues [224]. - License and royalty revenue decreased by 52%, or $1,124, for the three months ended September 30, 2025, primarily due to the one-time recognition of deferred revenue of $1,227 from a terminated licensing agreement [225]. - Total revenues for the nine months ended September 30, 2025, decreased by 31%, or $14,164, compared to the same period in 2024, mainly due to decreases in license and royalty revenue and manufacture and supply revenue [228]. - License and royalty revenue for the nine months ended September 30, 2025, decreased by 82%, or $11,847, primarily due to the one-time recognition of deferred revenues of $11,544 from terminated licensing agreements [230]. Research and Development - R&D expenses are expected to remain significant as the company develops existing product candidates and identifies new opportunities [210]. - Research and development expenses decreased by 14%, or $739, for the three months ended September 30, 2025, primarily due to lower clinical trial costs associated with the Anaphylm program [236]. - R&D share-based compensation increased by $1,000, or 323%, primarily due to acceleration of compensation related to severance [239]. - R&D personnel costs increased by 10% or $464 for the nine months ended September 30, 2025, mainly due to one-time severance expenses [248]. - R&D expenses decreased by 9% or $1,367 for the nine months ended September 30, 2025, mainly due to a reduction in clinical trial costs associated with the Anaphylm program [246]. Cost Management - The company is managing costs in preparation for a potential decline in Suboxone revenue and focusing on regulatory activities for Anaphylm [213]. - Selling, General and Administrative expenses include costs related to executive compensation, legal fees, and market research [211]. - Selling, general and administrative expenses increased by 38% or $12,856 for the nine months ended September 30, 2025, primarily due to higher commercial spending of approximately $5,950 for Anaphylm launch and regulatory fees of approximately $4,310 [249]. Financing Activities - The company sold 7,457,627 shares of Common Stock under the ATM facility for net proceeds of approximately $21,261 for the nine months ended September 30, 2025 [256]. - The company completed a public offering of 21,250,000 shares at $4.00 per share, resulting in net proceeds of $79,900 after underwriting discounts [263]. - Net cash provided by financing activities rose to $101,957 thousand, up from $83,435 thousand in the prior year, driven by net proceeds from the public offering and higher ATM proceeds [267]. - The company expects to incur significant operating losses and negative cash flows for the foreseeable future, indicating a reliance on external financing to achieve its operating plan [270][271]. - The company has utilized existing cash and equivalents for product pipeline development and working capital, with no assurance that future funding will be available on reasonable terms [269]. Debt and Interest - Interest expense consists of costs on the outstanding balances of 13.5% Notes, payable quarterly [215]. - The company has substantial ongoing interest payments and principal repayments related to its 13.5% Notes starting in June 2026, with a significant portion of revenues dependent on a single customer, Indivior [273]. - Interest expense related to royalty obligations increased by 5%, or $74, for the three months ended September 30, 2025, compared to the same period in 2024 [234]. - Interest expense was $8,342 for the nine months ended September 30, 2025, compared to $8,343 for the same period in 2024 [250]. - Interest income and other income, net decreased by 69%, or $673, for the three months ended September 30, 2025, compared to the same period in 2024 [234]. Cash Position - The company had $129,063 in cash and cash equivalents as of September 30, 2025, providing liquidity for operating needs for at least the next twelve months [254]. - For the nine months ended September 30, 2025, net cash used for operating activities increased to $(43,963) thousand from $(29,270) thousand in the prior year, primarily due to a net loss increase of $24,842 thousand [264][265]. - Interest income and other income, net increased to $3,115 for the nine months ended September 30, 2025, from $2,703 in 2024, primarily due to an ERTC credit received [253].

Financial 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].

Core Insights - Aquestive Therapeutics is progressing towards the potential launch of Anaphylm, an innovative sublingual film for treating severe allergic reactions, with a scheduled PDUFA goal date of January 31, 2026 [2][4] - The company is expanding its commercial readiness and regulatory discussions in the U.S., Canada, and the EU, aiming to enhance patient access to epinephrine treatments [5][6] - Financial results for Q3 2025 show a 4% year-over-year revenue increase, although total revenues decreased from $13.5 million in Q3 2024 to $12.8 million in Q3 2025 due to prior year deferred revenue recognition [13][17] Financial Performance - Total revenues for Q3 2025 were $12.8 million, a decrease from $13.5 million in Q3 2024, primarily due to the one-time recognition of deferred revenue in the previous year [13] - Manufacture and supply revenue increased to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, driven by growth in Sympazan and Suboxone revenues [14] - 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 [17] Product Development - Anaphylm, if approved, would be the first oral medication for severe allergic reactions, designed to improve patient compliance and accessibility [3][22] - The company is also advancing AQST-108, a topical epinephrine gel for alopecia areata, with an IND application expected to be submitted in Q4 2025 [7][24] - Recent patent expansions for Anaphylm extend protection into 2037, highlighting the product's long-term commercial potential [6] Strategic Initiatives - The company is enhancing its commercial and medical infrastructure in preparation for a potential U.S. launch of Anaphylm in Q1 2026 [5] - Strategic funding commitments and equity financing have positioned the company to support its mission of making epinephrine treatments more accessible [2] - The addition of new leadership for the AdrenaVerse clinical pipeline indicates a commitment to developing further products from this technology platform [8]

Core Viewpoint - Aquestive Therapeutics is making strategic leadership changes to support the potential launch of Anaphylm™, a novel epinephrine product, and to enhance its development pipeline [1][2][4] Leadership Changes - Dr. Matthew Davis has been appointed as Chief Development Officer, bringing over 20 years of experience in drug development and medical leadership [2][3] - Dr. Gary Slatko returns as interim Chief Medical Officer, with over three decades of experience in regulatory science and drug safety [3] - Peter Boyd has been promoted to Chief People Officer, having led various functions within the company since 2013 [4][5] Product Development - Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate designed for the rescue treatment of severe allergic reactions [7] - If approved by the FDA, Anaphylm would be the first oral medication for anaphylaxis, with a unique delivery method that does not require water or swallowing [7] Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a portfolio that includes four commercialized products [8] - The company collaborates with pharmaceutical firms to develop new molecules using proprietary technologies like PharmFilm® [8]

Core Insights - Aquestive Therapeutics, Inc. is hosting a live fireside chat on November 6, 2025, focusing on its product candidate Anaphylm™ (dibutepinephrine) Sublingual Film, discussing regulatory progress and commercial readiness [1][2] Company Overview - Aquestive Therapeutics is a pharmaceutical company dedicated to improving patients' lives through innovative science and delivery technologies, developing orally administered products to deliver complex molecules [5] - The company has four commercialized products marketed by its licensees globally and collaborates with pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [5] Product Details - Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug that is designed to be administered without water or swallowing, making it user-friendly [4] - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis, with its trade name conditionally approved [4]

Core Insights - Aquestive Therapeutics is advancing its product candidate Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, with multiple presentations scheduled at the 2025 ACAAI Annual Meeting [1][2] Company Overview - Aquestive Therapeutics focuses on innovative science and delivery technologies to improve patient lives through the development of orally administered products [4] - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [4] 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] - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, with its trade name conditionally approved [3]

Core Insights - Aquestive Therapeutics, Inc. will report its third quarter results for the period ending September 30, 2025, and provide business updates on November 5, 2025 [1] - A conference call for investors is scheduled for November 6, 2025, at 8:00 a.m. ET, with a live webcast available on the company's website [2] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies, aiming to improve patients' lives [3] - The company has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [3] - Aquestive is developing a late-stage proprietary product candidate for severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatological conditions like alopecia areata [3]