Aquestive Therapeutics, Inc. (AQST) SEC Filings & Earnings Calls

Regulatory approval not guaranteed; FDA may still issue CRL or require additional studies.

“Resubmission follows January 2026 CRL; Class 2 response indicates FDA may need more time.”

Dependence on Eton's commercial execution and FDA full approval for ages 2-5.

“Milestone payments contingent on first commercial sale and FDA approval for ages 2-5.”

Revenue concentration risk from single product partnership.

“License covers only LIBERVANT; limited diversification.”

FDA may determine resubmission incomplete, refuse to file, or extend review period; expedited review may not be granted.

“Risk that FDA may determine NDA resubmission does not constitute a complete response to the CRL.”

FDA review timeline and potential for additional CRL or denial; regulatory risk remains.

“FDA will determine the resubmission classification and establish the applicable review timeline following its initial review” · word for word

FDA approval risk remains; CRL deficiencies addressed but expedited review not guaranteed.

“The Company will request an expedited review upon resubmission, though no shortened or expedited review timeline can be guaranteed.” · word for word

Company is pre-revenue; relies on successful approval and launch of Anaphylm.

“Forward-looking statements highlight risks of sufficient capital and cash resources.”

Anaphylm FDA approval failure

“On January 30, 2026, the Company received a CRL that focused on administration and labeling guidance.” · word for word

Libervant market access blocked

“the FDA converted the approval of Libervant for patients aged between two and five years to a 'tentative approval' and Aquestive has ceased marketing activities for Libervant in the United States.” · word for word

High debt and interest rate exposure

“Interest expense on Term Loan Facility at a floating rate equal to three-month SOFR, subject to a floor of 2.75%, plus an applicable margin of 6.25%”

Suboxone revenue concentration and decline

“Suboxone branded products retain approximately 24% film market share as generic film-based products have penetrated this market.” · word for word

Regulatory risk: NDA resubmission may not be accepted or approved by FDA; prior Complete Response Letter indicates previous issues.

“The Company received a Complete Response Letter (CRL) from the FDA in January 2026 which indicated that, in a previous human factors study, participants had difficulty opening the pouch, tore the film during pouch opening, incorrectly placed the film during administration.” · word for word

Regulatory risk for Anaphylm NDA resubmission.

“NDA resubmission subject to completion of required studies and FDA response timelines.”

Debt refinancing increases leverage.

“New $150 million debt facility with Oaktree.” · word for word

Anaphylm approval delay risk

“The Company continues to plan for resubmission of the NDA in the third quarter of 2026, subject to completion of the HF and PK studies and expected typical response times from the FDA.” · word for word

Libervant market access loss

“Proprietary product revenue, net decreased by $319 for the three months ended March 31, 2026 compared to the same period in the prior year. This decrease was primarily due to the withdrawal of Libervant from the market as U.S. market access ended in April 2025.” · word for word

Suboxone revenue concentration risk

“Suboxone branded products retain approximately 25% film market share as generic film-based products have penetrated this market.” · word for word

High debt and royalty obligations

“Interest expense was $2,903 and $2,782 for the three months ended March 31, 2026 and 2025, respectively. These amounts represent interest incurred on the outstanding 13.5% Notes.” · word for word

Regulatory and clinical risk remains; final FDA meeting minutes pending, and PK/HF studies still to be completed.

“Final FDA meeting minutes expected by early May 2026; Company plans to address all feedback in PK study design and submit HF study protocol for FDA review.” · word for word

Key legal/compliance leadership transition; potential execution risk during regulatory interactions.

“Departure of Chief Legal Officer and Chief Compliance Officer; successor from outside firm.”

Regulatory risk: FDA Complete Response Letter for Anaphylm; resubmission timeline extended to Q3 2026.

“Reaffirms guidance to resubmit Anaphylm NDA in Q3 2026; Type A meeting with FDA expected within 30 days.”

Dilution risk: warrant for 375,000 shares and potential $5M share issuance.

“Warrant Issuance Agreement for 375,000 shares at $4.00; Share Purchase Commitment Agreement for at least $5,000,000.”

Customer concentration risk

“During the years ended December 31, 2025 and 2024, Indivior represented 73% and 62% of our total revenue, respectively.” · word for word

Product liability litigation risk

“We have been named as a defendant with Indivior in product liability claims related to dental injuries for use of Suboxone.” · word for word

Manufacturing and supply chain risk

“Any delay or interruption in our ability to meet commercial demand may result in the loss of significant potential revenues and could adversely affect our ability to gain market acceptance for approved products as well as a potential default of our supply commitments or obligations.” · word for word

Regulatory delay risk for key product Anaphylm; resubmission and approval timeline uncertain.

“CRL received; resubmission expected Q3 2026; no guarantee of approval.”

FDA approval delay risk for Anaphylm

“FDA deficiencies preclude labeling discussions; potential delay beyond PDUFA date of Jan 31, 2026.”

Anaphylm approval not guaranteed; FDA could require additional inspections.

“It is possible that further inspections could be necessary for the FDA approval of Anaphylm.” · word for word

Suboxone manufacturing revenue declining, offset by newer collaborations.

“Manufacturing business remains steady, with the gradual decline of Suboxone being offset by growth across newer collaborations.” · word for word

Libervant market access loss

“As a result of the District Court ruling, the FDA converted the approval of Libervant for patients aged between two and five years to a "tentative approval" and Aquestive has ceased marketing activities for Libervant in the United States.” · word for word

Suboxone revenue decline

“Suboxone branded products retain approximately 25% film market share as generic film-based products have penetrated this market.” · word for word

High debt and royalty obligations

“Interest expense related to royalty obligations was $4,304 and $4,075 for the nine months ended September 30, 2025 and 2024, respectively.”