Aquestive Therapeutics, Inc. Q2 FY2025 earnings call

• Dan Barber discussed Anaphylm's progress: on track with FDA review, advisory committee preparations, pre-commercial launch, financing, and international expansion. Mentioned AQST-108's IND opening and human studies planned. Base business grew year-over-year adjusted for onetime events, driven by international products.
• Ernie Toth talked about financial results, evaluating financing alternatives for Anaphylm launch, manufacturing business steady with Suboxone decline offset by new collaborations (Ondif, Sympazan, Emylif), and supply chain unaffected by tariffs.

Manufacture and supply revenue increased to $9.6 million in the second quarter of 2025 from $8.1 million in the second quarter of 2024, primarily due to increases in Ondif partially offset by decreases in Suboxone revenues. For the 6 months ended June 30, 2025, manufacture and supply revenue decreased to $16.8 million from $18.6 million in the prior year, primarily due to decreases in Suboxone revenues partially offset by increases in Ondif revenue. Total revenues in Q2 2025 were $10 million, up $0.3 million or 3% year-over-year excluding onetime deferred revenue impact, but down from $20.1 million in Q2 2024 including that onetime revenue.

Aquestive's full year 2025 financial guidance remains unchanged. The company expects total revenue of $44 million to $50 million, and non-GAAP adjusted EBITDA loss of $47 million to $51 million. Revenue guidance for 2025 no longer includes revenue for Libervant for ages between 2 and 5. Guidance includes pre-approval launch spending for Anaphylm, costs associated with Anaphylm NDA submission and filing fee, pediatric trial completion, and advisory committee preparations if required.

• Risks related to FDA approval process, including uncertainty around advisory committee meetings. Payer access barriers such as pricing, prior authorization, and deductibles. Financing risks for Anaphylm launch. Market competition risks in the severe allergic reaction rescue market.

Q: Could you provide more details on the likelihood of an FDA Ad Comm meeting and confidence in clinical data package?

A: Dan Barber said FDA is in mid-cycle review, expecting clarity on Ad Comm in coming weeks. Carl Kraus stated the clinical package is robust with 10 studies, over 930 exposures, and over 350 subjects.

Q: Comments on out-of-pocket exposure, payer landscape, and cash pay initiative?

A: Daniel Barber said discussions with payers are about awareness pre-approval. Out-of-pocket exposure is industry-wide. Cash pay is important for near-term launches and likely to grow over time.

Q: Review of former CRLs and learning for Anaphylm?

A: Daniel Barber said learned to listen to FDA, focusing on completing all FDA-requested studies, like the oral allergy syndrome study with repeat dose arm as per FDA's requests.

Q: Safety details of pediatric study and confidence in NDA submission?

A: Carl Kraus said pediatric study showed comparable PK/PD to adult dose, no safety differences in pediatric population, and data is in line with expectations.

Q: Business development strategy for Anaphylm ex U.S. and ex U.S. pricing?

A: Daniel Barber said always looking for broad coverage, whether launch by company or with partner. Ex U.S. pricing not a major concern as rescue market is not chronic and price point is lower than high-priced biologics.

Q: Ideal physician for Anaphylm and coverage confidence?

A: Sherry Korczynski said ideal physicians include allergists who prescribe many epinephrine prescriptions. Confident in broad payer coverage within first 6 months of launch.

Q: Post-neffy launch patient research and activation?

A: Sherry Korczynski said patients want choice, easy carry and use. Consumer education and direct-to-consumer efforts help increase awareness and drive product use to prevent anaphylaxis deaths.