Aquestive Therapeutics (AQST) Q3 2024 earnings summary

Executive summary

• Achieved major clinical milestones in Q3 2024, including positive OASIS study results for Anaphylm, completion of all planned adult studies, and a pre-NDA meeting scheduled for Q4 2024.

• Libervant for ages 2–5 launched nationwide in April 2024, with expanded sales force, Medicaid coverage in all states, and growing prescription volume.

• AQST-108 program advancing for alopecia areata, with pre-IND meeting scheduled for Q4 2024 and Phase 2a study planned for 2025.

• Ended Q3 2024 with $77.9 million in cash, extending runway into 2026.

• One-time license and royalty revenue recognized in Q3 2024, including $11.5M from terminated agreements.

Financial highlights

• Q3 2024 total revenues increased 4% year-over-year to $13.5M, driven by one-time license and royalty revenue and Libervant's pediatric launch.

• Net loss for Q3 2024 widened to $11.5M ($0.13/share) from $2M ($0.03/share) in Q3 2023, mainly due to higher R&D and SG&A expenses.

• Non-GAAP adjusted EBITDA loss was $6.6M in Q3 2024 vs. $1.3M in Q3 2023.

• R&D expenses increased to $5.3M and SG&A to $12.1M in Q3 2024, reflecting clinical development and commercial expansion.

• Cash and cash equivalents stood at $77.9M as of September 30, 2024.

Outlook and guidance

• 2024 guidance unchanged: total revenues of $57M–$60M and non-GAAP adjusted EBITDA loss of $20M–$23M.

• NDA submission for Anaphylm planned for Q1 2025, with potential launch in Q1 2026 if approved.

• AQST-108 Phase 2a study in alopecia areata planned for 2025, pending FDA alignment.

• Continued expansion of Libervant for ages 2–5 and advancement of AQST-108 program.