aibioAquestive enters $150 million debt facility with Oaktree
Tickers AQST
The facility refinances Aquestive's existing debt. It starts with $55.0 million at signing and adds tranches tied to FDA approval and sales milestones.
Key facts
- Company
- Aquestive Therapeutics, Inc. (NASDAQ: AQST)
- News type
- Debt Financing
- Primary source
- Aquestive Therapeutics, Inc. 8-K (2026-05-13)
The facility
Aquestive Therapeutics, Inc. entered into a new $150 million debt facility with Oaktree Capital Management, L.P., which the company calls a leading life sciences debt provider. The company said the facility refinances its existing debt and will save $45 million in principal payments over the next three years. The release names Oaktree Capital Management, L.P. as the lender and gives no closing date. It names no administrative agent, placement agent, financial advisor or counsel.
What is available at signing
The company says $55.0 million is provided at signing. Aquestive can access $20 million more if the FDA approves Anaphylm. A third tranche of $25.0 million becomes available upon specified sales milestones. The final tranche of up to $50.0 million requires the mutual consent of the lenders and the company. Principal payments do not begin until maturity in 2031.
The $55.0 million at signing is larger than the $52.4 million of cash used in operations in 2025, according to the 10-K. The rest of the $150 million headline depends on an FDA approval, on sales and on lenders agreeing. The release describes the interest rate only as improved and gives no figure for it. The $45 million saving is the company's own estimate.
The regulatory path
Anaphylm is a no-needle, no-device epinephrine product candidate for the treatment of Type I allergic reactions, including anaphylaxis. The FDA issued a Complete Response Letter dated January 30, 2026. The release says the letter did not identify any chemistry, manufacturing or controls deficiencies, and that the clinical results supporting comparability to auto-injectors were not questioned. In the first quarter, Aquestive completed a Type A meeting with the FDA and aligned on study designs for human factors validation and pharmacokinetics studies. Those studies are required to address the deficiencies the letter identified.
The company reaffirmed its guidance to resubmit the NDA in the third quarter of 2026, subject to completing the required studies and to FDA response times. It says it will request an accelerated review, but the release states that no expedited review can be guaranteed. The tranche tied to approval therefore depends on studies not yet completed, a resubmission not yet made and an FDA decision that the company places in 2027.
The business behind the debt
Aquestive describes itself as a pharmaceutical company developing medicines that are alternatives to invasive and inconvenient standard-of-care therapies. The 10-K says it has four licensed commercialized products marketed by its licensees, and that it is the exclusive manufacturer of those products. It says it is the worldwide leader in oral film drug delivery and manufacturing.
The 10-K also describes the AdrenaVerse epinephrine prodrug platform. The release says the second Phase 1 trial of AQST-108, a topical epinephrine gel, saw no drug related adverse events and no sign of systemic absorption, and that the company saw a biomarker signal through suppression of TSLP compared with placebo.
Losses and cash
The 10-K reports a net loss of $83.8 million for 2025, against $44.1 million for 2024. Cash used in operations rose to $52.4 million from $35.8 million. Research and development expense fell to $17.2 million from $20.3 million. The release says cash and cash equivalents were $110.7 million as of March 31, 2026.
The release reports a first-quarter 2026 net loss of $8.1 million, against $22.9 million a year earlier, on revenue of $14.4 million, up from $8.7 million, with license and royalty revenue of $5.4 million against $0.8 million, primarily due to royalty revenue from Zevra. Selling, general and administrative expense was $11.0 million, down from $19.1 million in the first quarter of 2025. The decrease primarily reflects a one-time Anaphylm PDUFA fee of $4.3 million in the prior-year quarter and lower legal fees of approximately $3.4 million.
What comes next
If the FDA approves Anaphylm in 2027, the company expects $150 million in cash and cash equivalents for the launch. The company says that figure counts the new facility and the $75 million strategic funding agreement with funds managed by RTW Investments, LP, and that the refinancing satisfies one of the pre-approval requirements for the RTW agreement.