Aquestive Therapeutics, Inc. Q3 FY2025 earnings call

• Anaphylm: FDA action date is January 31, 2026; allergist awareness is high with over 25% completing CME; prelaunch activities are on track for Q1 2026 launch if approved; marketing materials ready, hiring district managers and sales reps, market access team interacting with payers, supply chain prepared. - Adrenaverse platform: Slowdown in pipeline initiatives in H1 2025, now resuming; added Dr. Matthew Davis as Chief Development Officer; AQST-108 development program for alopecia areata with pre-IND submitted, safety study in men starting Jan 2026. - Regulatory: Positive interaction with Health Canada, no further studies needed for filing; expect full feedback from EMA by early Q1 2026; base business provides cash flow. - Financing: Equity raise and strategic financing agreement in August, well-positioned for commercial launch; working on refinancing existing debt.

Manufacturer and supply revenue increased to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, primarily due to increases in Sympazan and Suboxone revenues. For the 9 months ended September 30, 2025, manufacturer and supply revenue decreased to $28.2 million from $29.3 million in the prior year, primarily due to decreases in Suboxone revenues partially offset by increases in Ondif revenues. The base business continues to provide cash flow and capabilities, with stable demand from Indivior and growth in the South American partnership focused on the Brazilian market.

• Full year 2025 financial guidance unchanged: total revenue $44M to $50M, non-GAAP adjusted EBITDA loss $47M to $51M. - Revenue guidance excludes Libervant for ARS patients aged 2-5 years; 2024 revenue included onetime deferred revenue from licensing agreement termination. - Non-GAAP adjusted EBITDA loss guidance includes prelaunch spending for Anaphylm, NDA submission costs, pediatric trial costs, and no Advisory Committee meeting costs.

• FDA review uncertainties due to government shutdown, but FDA aims for on-time review. - Competition risks, including competitors' citizens petition which Aquestive views as factually incorrect and hurting credibility with FDA. - Regulatory and commercialization risks for Anaphylm and other pipeline programs.

Q: Any new comments on competitors' citizens petition and impact on FDA decision?

A: Competitors' citizens petition was a significant resource use, Aquestive views it as factually incorrect and expects zero impact on review.

Q: Thoughts on pricing and access relative to competitors?

A: Will price responsibly with patient-first approach, explore cash pay, co-pay savings, and work with payers for coverage.

Q: Optimal timing for partnering ex U.S.?

A: Conversations ongoing, closer to approval is better, with plans to file in Canada H1 2026 and expect EMA feedback early Q1 2026.

Q: Adrenaverse platform alternative routes?

A: Sky is the limit, focusing on epinephrine now but exploring other technologies.

Q: Debt refinancing priorities?

A: Looking for lowest coupon, flexibility, and partner to grow with.

Q: FDA review focus and DTC plans?

A: FDA asking expected questions, DTC not big TV ads initially, focused on patient-centric disciplined approach.

Q: Patent importance for Anaphylm?

A: Two new patents on epinephrine absorption and release are significant for blocking.

Q: Supply chain and on-time approval?

A: Supply chain prepared, can get drug into channel in Q1, manufactured in Indiana.

Q: Pushback from docs on Anaphylm?

A: Foundational is safety and efficacy, medical affairs team working on convincing.

Q: AQST-108 trial details?

A: Small safety study in men starting Jan 2026, followed by 24-week Phase IIa study with 40-60 individuals.