Aquestive Therapeutics, Inc. Q3 FY2024 earnings call

• Anaphylm: Announced top-line results from OASIS study showing rapid symptom resolution (median time to full symptom resolution dropped from 74 minutes to 12 minutes when using Anaphylm), submitted pre-NDA briefing book to FDA, expecting pre-NDA meeting in Q4, plan to start pediatric pharmacokinetic study post-approval, aiming for Q1 2025 NDA filing and Q1 2026 launch if approved.
• Libervant: Expanded national retail distribution, achieved Medicaid coverage in all 50 states, agreements with top PBMs, 12 sales colleagues educating physicians, prescriptions increasing from September to October.
• AQST-108: Submitted briefing book to FDA for pre-IND meeting, planning Phase 2a study in 2025 to evaluate benefits for alopecia areata.

Total revenues in the third quarter of 2024 increased to $13.5 million from $13 million in the third quarter of 2023, a 4% increase driven by license and royalty revenue from deferred revenue recognition, offset by decreases in manufacture and supply revenue. Manufacture and supply revenue decreased to $10.7 million in Q3 2024 from $11.4 million in Q3 2023. For the nine months ended September 30, 2024, total revenues were $45.7 million compared to $37.4 million in the prior year, driven by license and royalty revenue and co-development fees, offset by decreases in manufacture and supply revenue. Research and development expenses in Q3 2024 were $5.3 million vs. $3.2 million in Q3 2023. Selling, general, and administrative expenses in Q3 2024 were $12.1 million vs. $7.4 million in Q3 2023.

• 2024 revenue outlook: approximately $57 million to $60 million, non-GAAP adjusted EBITDA loss approximately $20 million to $23 million.
• For Anaphylm: Conclude supportive studies, engage FDA in pre-NDA meeting, commence pediatric study, pre-commercial activities for planned Q1 2026 launch if approved.
• Continue expansion of Libervant's commercial launch for 2-5 year-olds and advance AQST-108 program.

• Regulatory risks related to product approval and labeling.
• Market risks including competition and payer dynamics.
• Uncertainties in clinical trial outcomes and commercialization.

Q: About Anaphylm's clinical briefing book and Libervant's PBM negotiations A: Dan Barber discussed Anaphylm's briefing book focusing on positive results and seeking FDA guidance, Sherry Korczynski talked about Libervant's positive PBM negotiations Q: NDA for Anaphylm and sales force for Anaphylm A: Carl Kraus prepared for Ad Comm consideration, Sherry Korczynski outlined sales force focus on allergists and high-decile prescribers Q: Importance of OAS study and Libervant pricing A: Carl Kraus emphasized OAS study's predictive model, Dan Barber noted Libervant's pricing not being an obstacle due to payer understanding Q: Libervant's filing timeline and Anaphylm's label discussion A: Dan Barber discussed Libervant's filing timeline, Carl Kraus highlighted Anaphylm's differentiating data in OASIS study for label Q: Cash runway and Phase 2a timeline for AQST-108 A: Ernie Toth discussed cash runway supporting pre-commercial activities, Carl Kraus outlined Phase 2a timeline with adaptive study design