Aquestive Therapeutics (AQST) investor relations material

Executive summary

• Completed human factors and pharmacokinetic studies for Anaphylm, addressing FDA CRL deficiencies and confirming readiness for NDA resubmission in Q3 2026, with commercial launch preparations underway and regulatory filings planned for Canada (Q4 2026) and EU (Q1 2027).

• AQST-108 topical gel program is advancing, with positive preclinical and clinical data and further studies planned for late 2026 and early 2027.

• Out-licensing and partnering opportunities for Libervant (U.S.) and Anaphylm (ex-U.S.) are being evaluated, with base business and manufacturing collaborations remaining consistently cash flowing.

• Major refinancing completed, including a $150 million Oaktree debt facility and a $55 million Term Loan Facility, with $45 million of 13.5% Notes repaid and a one-time $11.7 million loss on extinguishment.

• Cash and cash equivalents as of June 30, 2026 were $98.5 million, supporting near-term liquidity and ongoing operations.

Financial highlights

• Q2 2026 total revenues increased 38% year-over-year to $13.8 million, with six-month revenues up 51% to $28.3 million, driven by higher manufacture, supply, license, and royalty revenues.

• Net loss for Q2 2026 was $22.9 million ($0.18/share); excluding a one-time $11.7 million debt extinguishment loss, net loss was $11.2 million; six-month net loss narrowed to $30.9 million.

• Non-GAAP adjusted EBITDA loss improved to $5.2 million in Q2 2026 from $9.3 million in Q2 2025; for the first six months of 2026, adjusted EBITDA loss was $7 million, down from $27 million in the prior year.

• Gross margin improved to 71% in Q2 2026 from 54% in Q2 2025; non-GAAP gross margin was 72% versus 57% year-over-year.

• Ended Q2 2026 with $98.5 million in cash and cash equivalents.

Outlook and guidance

• Maintaining full-year 2026 guidance: total revenue of $46–$50 million and non-GAAP adjusted EBITDA loss of $35–$30 million.

• Anaphylm NDA resubmission expected in Q3 2026, with potential FDA approval and launch in early 2027; Canadian and EMA filings planned for Q4 2026 and Q1 2027, respectively.

• Expecting $75 million in launch funds from RTW and $20 million from Oaktree upon FDA approval of Anaphylm.

• AQST-108 clinical development to continue into 2027.

• Launch preparations and commercial strategy are aligned with anticipated FDA review timelines.