Aquestive Therapeutics (NASDAQ:AQST) said it resubmitted its application for Anaphylm, an epinephrine sublingual film intended for severe allergic reactions, before the end of the third quarter and is preparing for a potential U.S. launch next year if the product receives Food and Drug Administration approval.
President and Chief Executive Officer Dan Barber said the FDA has assigned a March 16, 2027, goal date for its decision on Anaphylm. While the company said it remains prepared for the possibility of an earlier decision, Barber emphasized that the FDA controls the review timeline.
“We are now focused on the next set of deliverables in our execution story,” Barber said, citing U.S. launch preparation, planned regulatory filings in Canada and Europe, and continued ex-U.S. licensing discussions.
Anaphylm Launch Preparations
Aquestive is hiring district sales managers and expects to deploy approximately 75 sales representatives to call on roughly 8,000 to 8,500 healthcare providers, primarily allergists, as well as certain pediatricians and otolaryngologists. Chief Commercial Officer Sherry Korczynski said the company intends to take a focused approach centered on high epinephrine prescribers rather than a broad initial rollout.
Korczynski said the commercial strategy will combine field promotion, medical-conference engagement and non-personal marketing. The company did not disclose its expected allocation of spending among those channels or provide pricing details for Anaphylm.
The company has also begun pre-approval information exchange discussions with the four largest pharmacy benefit managers and other health plans. Barber said Aquestive plans to use the product’s clinical data to support its case for payer coverage, while recognizing that contracting discussions will be necessary for a product seeking a premium versus generic auto-injectors.
Barber said the company will judge its initial commercial progress based on the percentage and quality of covered lives, adoption among the physicians targeted by its sales force, and the efficiency of commercial spending relative to uptake.
Management emphasized what it views as Anaphylm’s pharmacodynamic profile as a potential differentiator. Chief Medical Officer Dr. Matt Greenhawt said the company is focusing its message on the speed of increases in blood pressure and heart rate, which he characterized as clinically relevant measures for epinephrine use during anaphylaxis. Greenhawt said the company’s studies showed peak blood-pressure responses in roughly five to eight minutes, depending on the study and parameter, and peak heart-rate responses in eight to 11 minutes.
Senior Vice President of Regulatory Affairs Melina Cioffi said the FDA’s review of the resubmission is intended to focus on items identified in the prior complete response letter. She added that inspection activity remains possible during the six-month review period, particularly involving clinical sites, and said the company is prepared should the agency inspect its U.S. manufacturing facility.
Libervant Licensing Deal
Aquestive also highlighted its agreement to grant Eton Pharmaceuticals exclusive U.S. commercialization rights for Libervant, its diazepam buccal film, subject to applicable regulatory approvals. The company received a $10 million upfront payment in October and could receive up to $47.5 million in regulatory and commercial milestones, along with a mid-teens royalty on annual U.S. net sales.
Aquestive will remain the exclusive manufacturer and supplier of Libervant under a long-term supply agreement. Barber said Eton was selected following a multi-bidder process and that Aquestive expects Libervant could become available to patients in 2027 if approved. Libervant is expected to be labeled for seizure clusters in epilepsy.
The company said the transaction places U.S. commercialization responsibility with Eton while allowing Aquestive to participate in the product’s future value and maintain its focus on Anaphylm.
Third-Quarter Results and Liquidity
Total third-quarter revenue was $7.6 million, down from $12.8 million a year earlier, primarily due to quarterly fluctuations in Suboxone product orders. Manufacture and supply revenue declined to $6.7 million from $11.5 million, reflecting lower Suboxone revenue that was partly offset by higher Ondif revenue.
License and royalty revenue was $0.8 million, compared with $1 million in the prior-year quarter. For the first nine months of 2026, total revenue increased 14% to $35.8 million, aided by higher royalty revenue, including $5 million related to Zevra.
- Third-quarter research and development expense was $4.3 million, compared with $4.5 million in the prior-year period.
- Selling, general and administrative expense fell to $14.2 million from $15.3 million, driven in part by lower legal fees, commercial spending and Anaphylm-related regulatory expenses.
- Net loss was $16.5 million, or $0.13 per share, compared with a loss of $15.4 million, or $0.14 per share, a year earlier.
- Non-GAAP adjusted EBITDA loss was $12.2 million, versus an $8.6 million loss in the prior-year quarter.
Chief Financial Officer Ernie Toth said Aquestive had $90.3 million in cash and cash equivalents as of Sept. 30, excluding the $10 million Libervant upfront payment received in October. The company expects to end 2026 with more than $70 million in cash and cash equivalents.
If Anaphylm is approved and other conditions are met, Aquestive expects potential access to $75 million under its RTW strategic funding agreement and another $20 million under an Oaktree term-loan facility. The company maintained its 2026 outlook for total revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $30 million to $35 million.
Pipeline Plans
Looking beyond Anaphylm, Barber said 2027 could be a pivotal year for the company’s AdrenaVerse epinephrine prodrug pipeline. Aquestive aims to provide meaningful clinical data for AQST-108 in atopic dermatitis and advance additional indications through proof-of-concept work. Management did not identify the additional potential indications it is evaluating.
About Aquestive Therapeutics (NASDAQ:AQST)
Aquestive Therapeutics, Inc is a specialty pharmaceutical company focused on developing and commercializing pharmaceutical products that use its proprietary PharmFilm oral film technology. The company’s films are designed to deliver medicines through the mouth, potentially offering alternatives to tablets, capsules, injections, or other conventional dosage forms.
Aquestive’s marketed products include Libervant (diazepam buccal film), an FDA-approved treatment for the acute, intermittent, and stereotypic episodes of frequent seizure activity associated with epilepsy, and Exservan (riluzole oral film), an FDA-approved treatment for amyotrophic lateral sclerosis.
