Aquestive Therapeutics, Inc.

Aquestive Therapeutics, Inc. is a pharmaceutical company focused on developing and advancing medicines through innovative science and delivery technologies, particularly non-invasive administration alternatives to standard of care therapies ¹. The company operates by developing proprietary product candidates and licensing commercialized products, for which it serves as the exclusive manufacturer ². Its production facilities are located in Portage, Indiana, with corporate headquarters and primary research laboratory facilities in Warren, New Jersey ³. The company's business model involves generating revenue from manufacturing and supplying products for licensees, licensing its intellectual property, co-development and research fees, and proprietary product sales ⁴.

The core of Aquestive's technology is PharmFilm®, an oral film drug delivery platform. The company states it is the worldwide leader in oral film drug delivery and manufacturing, having supplied over 2 billion doses for prescription pharmaceutical use ⁵. PharmFilm® is engineered with proprietary polymer compositions, formulations, and manufacturing techniques to ensure uniform API distribution and target absorption levels ⁶. This technology offers advantages such as faster onset of action, ease of administration without a device, direct bloodstream absorption reducing first-pass effects, reduced gastrointestinal side effects, and customizable delivery routes and taste profiles ⁷.

Aquestive's product portfolio includes proprietary growth drivers and licensed products. Key proprietary growth drivers include Anaphylm™ (dibutepinephrine) sublingual film and AQST-108 (epinephrine) topical gel, both emerging from the AdrenaVerse™ epinephrine prodrug platform ⁸. Anaphylm™ is a non-device based, orally delivered epinephrine prodrug product candidate for severe allergic reactions, including anaphylaxis, aiming to provide an alternative to intramuscular injections ⁹. AQST-108 is a topically delivered adrenergic agonist prodrug being developed for alopecia areata, an autoimmune hair loss disease ¹⁰. The company's proprietary CNS product is Libervant® (diazepam) Buccal Film, developed as an alternative to device-dependent rescue therapies for refractory epilepsy ¹¹.

The company's licensed commercial products generated $44,545 thousand in revenue in 2025, down from $57,561 thousand in 2024 ¹². These products include Suboxone®, a sublingual film for opioid dependence, for which Aquestive is the sole and exclusive supplier and manufacturer, having produced over 3.0 billion doses since 2010 ¹³. Suboxone® branded products retained approximately 24% film market share as of December 31, 2025 ¹⁴. Emylif®, an oral film formulation of riluzole for ALS, is marketed in the EU by Zambon, from whom Aquestive earned a $500 milestone payment in 2025 ¹⁵. Ondif®, an oral soluble film formulation of ondansetron for nausea and vomiting, is licensed to Hypera in Brazil, with Aquestive manufacturing and supplying the product ¹⁶. Sympazan®, an oral soluble film formulation of clobazam for Lennox-Gastaut syndrome, was licensed to Assertio Holdings, Inc. in October 2022 for an upfront payment of $9,000, with Aquestive remaining the exclusive manufacturer and supplier ¹⁷. KYNMOBI®, a sublingual film formulation of apomorphine for Parkinson's disease, was licensed to Sunovion, but Aquestive sold its rights to royalties and milestone payments to Marathon in November 2020 for an upfront payment of $40,000 and an additional $10,000 milestone payment ¹⁸. Sunovion voluntarily withdrew KYNMOBI from the U.S. and Canadian markets in June 2023 ¹⁹. Azstarys®, an FDA-approved product for ADHD, generates milestone and royalty revenues for Aquestive through an agreement with Zevra (formerly KemPharm, Inc.) ²⁰.

For the year ended December 31, 2025, total revenues were $44,545 thousand, a 23% decrease from $57,561 thousand in 2024 ²¹. Manufacture and supply revenue increased 1% to $40,225 thousand in 2025 from $39,976 thousand in 2024, primarily due to a $3,795 thousand increase in Ondif revenues, partially offset by a $3,482 thousand decrease in Suboxone revenues ²². License and royalty revenue decreased 77% to $3,519 thousand in 2025 from $15,345 thousand in 2024, mainly due to a one-time recognition of deferred revenues of $11,544 thousand in the prior year ²³. Co-development and research fees decreased 34% to $1,279 thousand in 2025 from $1,925 thousand in 2024 ²⁴. Proprietary product revenue, net, decreased by $793 thousand in 2025, primarily due to a change in the estimated returns allowance provision following the withdrawal of Libervant from the market in April 2025 ²⁵. Gross profit is not explicitly stated, but total costs and expenses were $115,596 thousand in 2025, up from $88,332 thousand in 2024 ²⁶. Operating loss was $71,051 thousand in 2025, compared to $30,771 thousand in 2024 ²⁷. Net loss was $83,784 thousand in 2025, compared to $44,137 thousand in 2024 ²⁸. Basic and diluted EPS was $(0.78) in 2025, compared to $(0.51) in 2024 ²⁹. Net cash used for operating activities was $52,432 thousand in 2025, an increase of $16,673 thousand from $35,759 thousand in 2024 ³⁰. Cash and cash equivalents were $121,169 thousand as of December 31, 2025, up from $71,546 thousand in 2024 ³¹. The company had $45,000 thousand in aggregate principal amount of 13.5% Senior Secured Notes outstanding as of December 31, 2025 ³².

In terms of year-over-year comparisons, total revenues decreased by $13,016 thousand, or 23%, in 2025 compared to 2024 ³³. Manufacture and supply revenue saw a slight increase of $249 thousand, or 1% ³⁴. However, license and royalty revenue experienced a significant decline of $11,826 thousand, or 77% ³⁵, and co-development and research fees decreased by $646 thousand, or 34% ³⁶. Proprietary product revenue, net, also decreased by $793 thousand ³⁷. Total costs and expenses increased by $27,264 thousand, or 30.9% ³⁸. R&D expenses decreased by $3,088 thousand, or 15%, primarily due to lower clinical trial costs for Anaphylm, partially offset by increased product research and personnel costs ³⁹. Selling, general and administrative expenses increased by $29,669 thousand, or 59%, driven by higher legal-related expenses of approximately $14,300 thousand, increased commercial spending of approximately $9,600 thousand for Anaphylm launch preparation, and a $4,310 thousand Anaphylm PDUFA fee ⁴⁰.

During the reported period, Aquestive completed the Anaphylm NDA submission in Q1 2025, which was accepted by the FDA on June 16, 2025, with a PDUFA target action date of January 31, 2026 ⁴¹. However, on January 30, 2026, the company received a Complete Response Letter (CRL) citing deficiencies in the Anaphylm Human Factors (HF) validation study related to pouch opening and incorrect film placement ⁴². The CRL did not question clinical trial results regarding comparability to auto-injectors or CMC issues ⁴³. The FDA requested a single PK study to understand the impact of packaging and labeling modifications ⁴⁴. The company plans to resubmit the NDA in Q3 2026, assuming completion of the HF and PK studies ⁴⁵. Internationally, the EMA provided positive feedback that no further clinical trials are needed for Anaphylm prior to regulatory submission, and Aquestive is working towards submissions in Europe and Canada in 2026 ⁴⁶. For Libervant, the FDA approved it on April 26, 2024, for U.S. market access for ARS patients aged two to five years, and granted seven years of Orphan Drug Exclusivity (ODE) in October 2024 ⁴⁷. However, on February 14, 2025, a U.S. District Court vacated the FDA's approval of Libervant for this age group, converting it to "tentative approval" due to an interpretation of ODE for a competing nasal spray product ⁴⁸. Aquestive has ceased marketing activities for Libervant in the U.S. and has requested the FDA confirm approval based on clinical superiority ⁴⁹. The company also completed an underwritten public offering on August 14, 2025, raising net proceeds of $79,900 thousand ⁵⁰. On August 13, 2025, Aquestive entered into a purchase and sale agreement with RTW Investments LP, agreeing to tiered revenue share payments for Anaphylm in exchange for a $75,000 thousand purchase price, contingent on FDA approval of Anaphylm and refinancing of existing 13.5% Notes ⁵¹. This agreement was amended on March 3, 2026, extending the Marketing Approval Deadline for Anaphylm to June 30, 2027 ⁵².

Aquestive Therapeutics anticipates needing substantial additional capital to fund its operations, including the commercialization of Anaphylm, if approved, and to commence quarterly principal payments on its 13.5% Notes starting in June 2026, unless these notes are refinanced or amended ⁵³. As of December 31, 2025, the company had $121,169 thousand in cash and cash equivalents ⁵⁴. The company believes its ongoing business, existing cash, expense management, potential asset sales or product outlicensing, and access to equity capital markets, including its ATM facility, provide near-term liquidity for at least the next twelve months ⁵⁵. The remaining authorized balance of the ATM facility was $78,000 thousand as of December 31, 2025 ⁵⁶.

A major growth area for Aquestive is Anaphylm™ (dibutepinephrine) sublingual film, which the company believes has the potential to be the first and only oral administration of epinephrine, if approved by the FDA ⁵⁷. Despite receiving a Complete Response Letter (CRL) on January 30, 2026, regarding deficiencies in the Human Factors (HF) validation study, the company plans to modify the pouch opening, instructions for use, and labeling, and conduct a new HF validation study ⁵⁸. The company also plans to address potential tolerability issues in its resubmission ⁵⁹. Clinical trial results regarding comparability to approved auto-injectors and CMC issues were not questioned in the CRL ⁶⁰. The FDA requested a single PK study to understand the impact of packaging and labeling modifications, which can be conducted in parallel with the HF study ⁶¹. Aquestive estimates resubmission of the NDA in Q3 2026, assuming completion of these studies and typical FDA response times, and plans to request accelerated review ⁶². Internationally, the EMA has indicated no further clinical trials are needed for Anaphylm prior to regulatory submission, and the company is working towards marketing authorization applications in Europe and New Drug Submissions (NDS) in Canada in 2026 ⁶³. The company believes these markets represent important opportunities for global expansion of its non-invasive epinephrine therapy ⁶⁴.

Another growth vector is AQST-108 (epinephrine) topical gel, a product candidate from the AdrenaVerse™ platform, being developed for alopecia areata ⁶⁵. The company completed the first human clinical trial for AQST-108, which assessed safety and local tolerability, with no serious adverse events or topical adverse events observed ⁶⁶. Zero post-dose AQST-108 concentrations in plasma were observed in Part 2 of the trial ⁶⁷. An IND for AQST-108 was opened in Q4 2025 ⁶⁸. Dosing for a second Phase 1 clinical trial was completed in Q1 2026, with data readout expected in Q2 2026, intended to further characterize safety, tolerability, and pharmacologic profile to inform future development opportunities ⁶⁹.

Operationally, the company expects its Research and Development (R&D) expenses to continue to be significant over the next several years as it develops existing product candidates like Anaphylm and AQST-108, and identifies or acquires additional product candidates ⁷⁰. The company plans to continue to manage business costs to appropriately reflect the anticipated general decline in Suboxone revenue and other external factors ⁷¹. It will focus on core value drivers for stockholders, including continued investments in ongoing product development for Anaphylm and AQST-108 ⁷². The company expects to incur significant operating losses and negative operating cash flows for the foreseeable future ⁷³.

Regarding capital allocation, the company's cash requirements for 2026 and beyond include expenses for continuing development and clinical evaluation of products, manufacturing and supply costs, regulatory filings, patent prosecution and litigation, commercialization costs for Anaphylm if approved, and quarterly principal payments on its 13.5% Notes starting in June 2026 ⁷⁴. The 13.5% Notes have an aggregate principal amount of $45,000 thousand and accrue interest at a fixed rate of 13.5% per annum, payable quarterly ⁷⁵. The company will also pay an installment of principal on these notes starting June 30, 2026, along with a portion of an Exit Fee ⁷⁶. The company intends to satisfy current and future debt service obligations with existing cash and cash equivalents and potential access to other funding ⁷⁷.

The company explicitly flags several structural headwinds and execution risks. The recent Complete Response Letter (CRL) for Anaphylm, focusing on administration and labeling guidance and deficiencies in the Human Factors validation study, has delayed the planned launch ⁷⁸. The company needs to complete additional human factors and a clinical trial, and there is no assurance that the FDA's concerns will be satisfied ⁷⁹. The U.S. market access for Libervant for ARS patients aged two to five years was converted to "tentative approval" due to a District Court ruling challenging the FDA's approval based on an interpretation of orphan drug exclusivity for a competitor's product, leading to a cessation of marketing activities ⁸⁰. The company's ability to market Libervant for any age group is restricted until the expiration of the orphan drug exclusivity or a determination of its inapplicability, or if the District Court's ruling is overturned ⁸¹. Overcoming orphan drug marketing exclusivity is difficult with limited precedent ⁸². A substantial portion of the company's revenues (73% in 2025 and 62% in 2024) is derived from a single customer, Indivior, for Suboxone, and any significant decline in these revenues or termination of the Indivior License Agreement would materially adversely affect the business ⁸³. The company expects erosion of Suboxone's market share over time ⁸⁴.

Aquestive faces material risks including the ability to address FDA concerns in the Anaphylm CRL, which requires additional human factors and a clinical trial, potentially delaying approval and increasing costs ⁸⁵. The company needs substantial additional capital to fund operations, including Anaphylm commercialization and quarterly principal payments on its $45,000 thousand 13.5% Notes starting in June 2026, and this capital may not be available on acceptable terms ⁸⁶. The company has incurred significant operating losses, with an accumulated deficit of $446,998 thousand as of December 31, 2025, and expects to continue incurring losses ⁸⁷. Competitive products, including a recently approved nasal spray device for anaphylaxis, pose a threat, and the orphan drug market exclusivity of a competitor's nasal spray product for epilepsy has restricted Libervant's U.S. market access for patients aged six years and older until January 2027, and has led to the vacating of approval for patients aged two to five years ⁸⁸. Reliance on third-party CROs for clinical trials and limited sources of supply for thin film foil and API introduce risks of delays, increased costs, and potential supply disruptions ⁸⁹. The company's substantial debt and debt service obligations could constrain investment and funding for operations ⁹⁰. Cybersecurity threats, including those amplified by AI, pose risks to information technology systems and data integrity ⁹¹. Changes in U.S. government policies, including tariffs and reductions in federal research funding, could adversely affect the business ⁹². Product liability claims, such as those related to dental injuries for Suboxone, represent a significant risk ⁹³.

Management's message emphasizes the company's commitment to advancing medicines through innovative science and delivery technologies, particularly non-invasive alternatives to standard of care therapies. They highlight the ongoing development of Anaphylm™ and the AdrenaVerse™ platform, alongside their four licensed commercialized products for which they are the exclusive manufacturer. A key strategic priority is to address the deficiencies raised in the Anaphylm Complete Response Letter (CRL) received on January 30, 2026, which focused on administration and labeling guidance and the Human Factors validation study ⁹⁴. The company plans to modify the pouch opening, instructions for use, and labeling, and conduct a new Human Factors validation study, along with a single PK study requested by the FDA, with an estimated NDA resubmission in Q3 2026 ⁹⁵. Another strategic priority is to pursue international regulatory strategies for Anaphylm, leveraging positive feedback from the EMA that no further clinical trials are needed for submission in Europe, and working towards submissions in Europe and Canada in 2026 ⁹⁶. A third priority is managing liquidity and funding requirements, acknowledging the need for substantial additional capital to commercialize Anaphylm, if approved, and to meet debt obligations, including commencing principal payments on the 13.5% Notes in June 2026 ⁹⁷. Management also notes the ongoing efforts to manage business costs in light of anticipated declines in Suboxone revenue and continued investments in product development activities for Anaphylm and AQST-108 ⁹⁸.