Aquestive Therapeutics, Inc. Q1 FY2025 earnings call

• Dan Barber discussed the FDA review of Anaphylm Epinephrine Sublingual film, expecting an FDA acceptance letter next month with an action date in late Jan/early Feb 2026, entering commercial prelaunch phase. Focus areas include building the right commercial team, increasing awareness among healthcare professionals through conferences and publications, engaging with payers using existing Libervant contracts, and strong advocacy work.
• Ernie Toth mentioned executing strategy to support Anaphylm NDA filing, steady manufacturing business with diversification, and first quarter financial results showing revenue decrease, R&D expense decrease, SG&A expense increase, and revised full-year 2025 guidance.

Total revenues decreased to $8.7 million in the first quarter of 2025 from $12.1 million in the first quarter of 2024. Manufacturer and supply revenue dropped to $7.2 million in Q1 2025 from $10.5 million in Q1 2024, mainly due to Suboxone revenue decline but offset by Ondif revenue increase. License and royalty revenue decreased 30% to $0.3 million in Q1 2025. Proprietary product revenue, net, increased. Aquestive's manufacturing business was steady, with Suboxone decline partially offset by growth in newer collaborations like Ondif, Sympazan, and Emylif. The manufacturing facility diversified operations.

Aquestive revised full-year 2025 financial guidance: expects total revenue of $44 million to $50 million and non-GAAP adjusted EBITDA loss of $47 million to $51 million. Revenue guidance no longer includes Libervant revenue for 2-5 year age group. Guidance includes pre-commercial spending for Anaphylm related to NDA submission, pediatric trial completion, and potential advisory committee meeting preparation.

Q: Update on commercial readiness efforts for Anaphylm including CMC manufacturing, scale up, and hiring of field force.

A: Dan Barber said manufacturing is in-house and well-prepared. Sherry Korczynski mentioned starting with ~50 sales representatives targeting top epinephrine prescribers like allergists, pediatricians, and NPPAs.

Q: Key goals in interacting with payers for Anaphylm access and timelines.

A: Sherry Korczynski said they have a market access VP, working with payers using Libervant contracts, expecting 80% coverage by end of first six months of launch.

Q: Learnings from Nepfi launch and thoughts on Ad Comm for Anaphylm.

A: Sherry Korczynski said Nepfi launch shows market expansion is critical. Carl Kraus mentioned Anaphylm has robust data set and is prepared to respond to FDA questions for Ad Comm.

Q: Envision of new division head impact on Ad Comm and review process.

A: Dan Barber said interactions have been with deputy division head, review team remains same, and ready for Ad Comm if needed.

Q: Awareness of Anaphylm with providers, measurement, and seasonality impact on launch.

A: Sherry Korczynski said heavy engagement with KOLs and allergy community, measuring awareness via baseline ATU trial, and market peaks in back to school season.

Q: DTC advertising strategies for Anaphylm and distribution infrastructure.

A: Sherry Korczynski said DTC layers in after physician awareness, distribution through retail channels with assessment of alternate models. Dan Barber mentioned DTC helps disease awareness.

Q: Ex-U.S. partnership for Anaphylm, regulatory submissions, and ideal early adopter prescribers.

A: Dan Barber said ex-U.S. partnerships are active, focusing on Canada, U.K., and EMA. Sherry Korczynski said ideal adopters are physicians seeing majority patients and those hearing patient needs.

Q: Cash needed for Anaphylm launch, Libervant revenue in Q2, and Ad Comm timeline.

A: Ernie Toth said cash provides runway, Libervant revenue in Q2 is minimal. Carl Kraus said FDA could alert on Ad Comm at any time, but hopeful by day 74.