Aquestive Therapeutics (AQST) Q2 2024 earnings summary

Executive summary

• Q2 2024 revenue increased 52% year-over-year to $20.1 million, driven by one-time deferred revenue recognition from terminated agreements, while net loss narrowed to $2.7 million from $5.8 million in Q2 2023.

• Advanced Anaphylm (epinephrine sublingual film) with positive clinical data; NDA submission planned for late 2024 or early 2025 and commercial launch targeted for late 2025 or early 2026, pending FDA approval.

• Libervant (diazepam buccal film) approved for ages 2–5 in April 2024; national retail distribution and expanded sales force expected by Q4 2024.

• Cash and cash equivalents stood at $89.9 million as of June 30, 2024, extending runway into 2026 after significant equity raises.

• Streamlined base business by terminating unprofitable collaborations and focusing on core products and pipeline growth.

Financial highlights

• Q2 2024 revenue was $20.1 million, up from $13.2 million in Q2 2023, mainly due to one-time recognition of $10.3 million in deferred revenue from terminated agreements.

• Excluding one-time items, total revenues decreased 26% year-over-year; manufacturer and supply revenue fell to $8.1 million due to timing of orders.

• Net loss for Q2 2024 was $2.7 million ($0.03/share), improved from $5.8 million loss in Q2 2023; non-GAAP adjusted EBITDA income was $1.8 million, versus a $3.3 million loss in Q2 2023.

• Gross margin improved to 77% (non-GAAP: 79%) from 50% (non-GAAP: 52%) year-over-year.

• Cash and cash equivalents at June 30, 2024: $89.9 million, up from $24.9 million in Q4 2023.

Outlook and guidance

• 2024 revenue guidance raised to $57–$60 million, reflecting deferred revenue recognition.

• Non-GAAP adjusted EBITDA loss guidance improved to $20–$23 million for full year 2024.

• NDA submission for Anaphylm expected late 2024/early 2025; Libervant national retail distribution for ages 2–5 expected in Q4 2024.

• Guidance includes completion of Anaphylm supportive studies, pre-NDA meeting, pediatric study initiation, and expanded Libervant launch.

• Management expects liquidity to be sufficient for at least the next twelve months, supported by cash on hand and expense management.