Aquestive Therapeutics, Inc. Q4 FY2025 earnings call

Dan Barber stated the company is in a great moment with a clear path for ANNAFILM to market in US and worldwide. Submitted Type A meeting request to FDA, expect discussion in 30 days, selected clinical research organizations, modified packaging. Added key clinical leaders, more than doubling medical affairs organization. On commercial side, guiding to launch with 50% more sales reps upon approval (75 reps vs previous 50), RTW extended revenue - sharing agreement and invested additional capital. Mentioned underlying allergy market growth, settlement in defamation lawsuit, focus on licensing Libervant in US, progress with ANNAFILM licensing in Europe, and progress with AQST - 108. Ernie Toth recapitulated financial results, outlined 2026 outlook of revenue $46,000,000 - $50,000,000 and non - GAAP adjusted EBITDA loss $30,000,000 - $35,000,000

Total revenues increased to $13,000,000 in Q4 2025 from $11,900,000 in Q4 2024 (10% increase driven by manufacturer and supply revenue). For full year 2025, total revenues decreased by $1,500,000 (3%) to $44,500,000 (excluding one - time deferred revenue recognition). Manufacturer and supply revenue increased to $40,200,000 for full year 2025 from $40,000,000 in 2024. R&D expenses decreased in Q4 2025 and full year 2025. Selling, general, and administrative expenses increased in Q4 2025 and full year 2025 (including one - time legal expenses). Net loss increased in Q4 2025 and full year 2025. Non - GAAP adjusted EBITDA loss had changes in Q4 2025 and full year 2025. Cash and cash equivalents were $121,200,000 as of 12/31/2025

2026 outlook: total revenue of $46,000,000 to $50,000,000 and non - GAAP adjusted EBITDA loss of $30,000,000 to $35,000,000. Expect to end 2026 at approximately $70,000,000 excluding additional proceeds from RTW or out - licensing transactions. Guidance includes costs for ANNAFILM NDA resubmission, precommercial infrastructure, AQST - 108 clinical trials, and regulatory applications for ANNAFILM in Canada and EU, not including sales and marketing costs if approved

Significant risks and uncertainties related to business, development, regulatory approval, and commercialization of products. Risks include those described in Risk Factors section and Annual Report on Form 10 - K. Uncertainties with clinical trials, regulatory reviews, commercial launch, and litigation

Q: About Type A meeting with FDA, confirmation on scheduling and goals.

A: Submitted request, expect meeting in 30 days, goals are to have clear alignment on executing studies.

Q: On RTW extension, timeline and terms.

A: Extension until 06/30/2027, terms unchanged, RTW invested additional $5,000,000.

Q: On adding 50% more sales reps, timing and reasons.

A: Hiring contingent offers out, ready upon launch for greater efficiency and closing white space.

Q: On trial design for ANNAFILM, modifications.

A: Have optionality, will meet FDA requirements, have protocols to take optionality into account.

Q: On DTC for ANNAFILM, approach.

A: Focus on reps, let competitors spend on DTC.

Q: On indication selection for AQST - 108.

A: Focus on alopecia areata, but have optionality for other topical indications.

Q: On citizen's petition for ANNAFILM.

A: Denied by FDA, validating data package.

Q: On promotional campaign for ANNAFILM, revised salesforce sizing.

A: Refining positioning and tactics, competitors' efforts inform launch plan.

Q: On timeline of AQST - 108 development relative to ANNAFILM.

A: Linked, prioritize ANNAFILM in short term, then 108 will pick up.

Q: On settlement with Norellis and Libervant market potential.

A: Settlement terms confidential, Libervant has potential but ANNAFILM is priority.

Q: On accelerated approval for ANNAFILM, analogs.

A: Competitor got CRL, resubmitted and got approval in 4 months, guiding to hit FDA requests.

Q: On submissions outside US for ANNAFILM.

A: After US submission.

Q: On timeline from ANNAFILM approval to full commercial launch.

A: Zero to eight weeks