Aquestive Therapeutics (NASDAQ:AQST) executives used the company’s fourth-quarter 2025 earnings call to outline a path forward for Anaphylm, its orally delivered epinephrine product candidate, following a Complete Response Letter (CRL) from the U.S. Food and Drug Administration. Management reiterated its intention to resubmit the New Drug Application (NDA) in the third quarter of 2026 and said it is preparing to conduct a human factors validation study and a supportive pharmacokinetic (PK) study requested by the FDA.
Anaphylm regulatory update and next steps
CEO Daniel Barber said the company believes it has “a very clear and achievable set of instructions” from the FDA for an NDA resubmission. The company has submitted a request for a Type A meeting with the agency and expects to meet within 30 days, consistent with FDA guidance, according to Senior Vice President of Regulatory Affairs Melina T. Cioffi. She said the briefing book submitted to the FDA outlines the company’s commitment to conduct the two studies requested in the CRL, and the meeting is intended to ensure alignment on how best to execute the work.
Chief Development Officer Matthew Davis said the upcoming PK study will be the company’s 12th PK trial on the product and will use the same vendor and laboratory used previously. He also said the study will include elements the FDA requested, including healthcare-administered treatments and some self-administration aligned with an updated instructions-for-use process to be validated in the human factors work. Davis said the company believes “maybe not all the arms are going to be necessary,” but added that it is prepared to run the trial as requested if the FDA prefers the full design.
Barber also said the company modified Anaphylm’s packaging to make the pouch easier to open, noting that the change has “no impact on stability or durability.”
Commercial preparation and sales force plans
On the commercial front, Barber said the company kept its core commercial leadership team intact following the CRL and continues to prepare for launch. He said the company now expects to launch with 75 sales representatives, up from its prior guidance of 50, describing the change as “50% more sales reps upon approval compared to our previous guidance.” Barber said planning indicates the company should be able to do this from “a close to cash neutral position by the end of 2027.”
Chief Commercial Officer Sherry Korczynski said the decision was based on improving reach and frequency in the allergist market and ensuring coverage of high-decile pediatricians. She cited smaller territories, improved efficiency, and reduced “white space” compared with a 50-representative model. Korczynski said the company is also expanding its presence in the allergy community, including larger medical affairs efforts and additional publications.
Asked about direct-to-consumer (DTC) advertising, Barber said the company believes DTC is best pursued once a product has achieved “a reasonable market share.” He said competitor spending is “growing the overall market,” and the company plans to focus on representative-driven outreach rather than matching aggressive DTC efforts early.
On launch timing following potential FDA approval, Barber said the timeframe for product availability and representatives in the field would be consistent with prior expectations, describing “zero to eight weeks” depending on how much the company can lean forward ahead of approval and the time required for supply chain steps.
Financing, cash position, and 2026 outlook
CFO Ernie Toth highlighted several financing and liquidity items, including a previously completed $85 million equity raise and a $75 million revenue interest financing arrangement with RTW tied to Anaphylm approval. During the call, management also discussed a newly announced extension of the RTW agreement, with Barber saying it can be consummated at any time before June 30, 2027. Toth confirmed the terms of the RTW agreement have not changed and said RTW also agreed to an additional $5 million strategic investment.
As of Dec. 31, 2025, the company reported $121.2 million in cash and cash equivalents. For 2026, Toth guided to total revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $30 million to $35 million. The company expects to end 2026 with approximately $70 million in cash, excluding additional proceeds from RTW or any out-licensing transactions. Toth said the 2026 guidance includes costs for the Anaphylm NDA resubmission, continued pre-commercial infrastructure spending, clinical trial costs for AQST-108, and regulatory applications for Anaphylm in Canada and the European Union. He noted the guidance does not include costs for sales and marketing of Anaphylm if approved by the FDA.
Financial results: revenue growth in Q4, higher SG&A driven by legal and launch spending
For the fourth quarter of 2025, total revenue increased to $13.0 million from $11.9 million in the prior-year quarter, which Toth attributed primarily to higher manufacture and supply revenue. Manufacture and supply revenue rose to $12.0 million from $10.7 million, driven by increases in Suboxone and Ondif revenues.
For the full year 2025, total revenue was $44.5 million, down from $57.6 million in 2024. Toth said 2024 included a one-time recognition of deferred revenue tied to terminated licensing and supply agreements; excluding that one-time impact, he said total revenue decreased by $1.5 million, or 3%, to $44.5 million in 2025. Full-year manufacture and supply revenue increased slightly to $40.2 million from $40.0 million, reflecting higher Ondif revenues partially offset by lower Suboxone revenues.
R&D expense decreased to $3.2 million in the fourth quarter from $4.9 million a year earlier, primarily due to lower Anaphylm clinical trial costs and lower share-based compensation. Full-year R&D expense decreased to $17.2 million from $20.3 million, reflecting lower clinical trial costs partially offset by higher product research expense and share-based compensation.
Selling, general and administrative (SG&A) expense rose sharply, particularly when including one-time legal expenses. Toth said fourth-quarter SG&A was $32.8 million, up from $16.0 million, primarily due to higher legal expenses of approximately $13.6 million and higher commercial spending of approximately $3.7 million in preparation for Anaphylm’s launch, among other items. For the full year, SG&A was $79.8 million compared with $50.2 million in 2024, driven by higher legal fees of approximately $14.3 million, higher commercial spending of approximately $9.6 million, the Anaphylm PDUFA fee of $4.3 million, and other increases, partially offset by lower severance and insurance costs.
Net loss for the fourth quarter of 2025 was $31.9 million, or $0.26 per share, including one-time legal expenses, compared with a net loss of $17.1 million, or $0.19 per share, in the prior-year quarter. For the full year 2025, net loss was $83.8 million, or $0.78 per share, including one-time legal expenses, compared with a net loss of $44.1 million, or $0.51 per share, in 2024.
Other pipeline and business updates
Barber said the company remains on track to file for Anaphylm in Europe and Canada before the end of 2026 and expects to meet with the U.K. MHRA in the coming weeks, while emphasizing U.S. prioritization. He also said the company is pursuing ex-U.S. licensing for Anaphylm in Europe.
On Libervant, Barber said that due to the timing of a potential Anaphylm launch, the company’s initial focus will be licensing Libervant in the U.S., noting that several parties are “already interested and actively engaged in discussions.” He pointed to forecasts that two nasal spray products for seizure clusters are expected to exceed $400 million in sales in the upcoming year, while saying the company believes Libervant could be an important option in the market. Barber also said the company cannot launch Libervant and Anaphylm within a month of each other and is prioritizing Anaphylm.
Barber said the company opened an IND for AQST-108 in December 2025, completed dosing of an initial safety study “last month,” and expects top-line clinical data in the near future. Davis said alopecia areata remains the current indication focus, while the company is also evaluating information that could inform other topical indications.
In legal matters, Barber said the company reached a settlement in December in a nine-year defamation lawsuit brought by a competitor and described the settlement as removing a distraction. He said settlement terms were confidential and added that the company believes the settlement is “cash neutral” for 2026 based on its guidance. Separately, Barber said a citizen petition filed by a competitor was denied by the FDA “last week,” which he characterized as a validating event for the company’s data package.
About Aquestive Therapeutics (NASDAQ:AQST)
Aquestive Therapeutics, Inc is a specialty pharmaceutical company focused on the development and commercialization of novel drug delivery systems. Leveraging its proprietary PharmFilm® technology, Aquestive designs thin-film formulations that facilitate sublingual, buccal and oral delivery of small molecules, offering rapid onset of action and improved patient compliance compared with traditional dosage forms.
The company’s lead product, Libervant® (diazepam) Buccal Film, is approved by the U.S.
