Aquestive Therapeutics, Inc. (AQST) Earnings

Management highlights

### Regulatory Progress for Anafilm (anisome-dibute epinephrine sublingual film) - Completed a Type A face-to-face meeting with the FDA after receiving a January 2026 Complete Response Letter; remaining requirements are an ongoing human factors validation study and an ongoing pharmacokinetic (PK) study. - Completed a positive interaction with the UK MHRA, which confirmed no additional clinical studies are required prior to marketing application submission. - Submitted a pediatric investigational plan to the EMA, a required step for EU marketing submission. - Submitted the human factors protocol for FDA review. The company confirms no additional clinical studies are needed for submissions to the EU, UK, and Canada, which combined with the U.S. would cover nearly 1 billion people if approved. ### Pipeline Progress - Completed a Phase 1 safety study for AQST-108, a topical product from the Adreniverse epinephrine prodrug platform, for androgenic alopecia. No drug-related adverse events or systemic absorption of the prodrug or epinephrine were observed. - Early directional, non-statistically powered biomarker data showed AQST-108 impacted TSLP cytokine levels in subjects with alopecia (a signal not seen in placebo), opening potential optionality across multiple inflammatory dermatology indications including alopecia areata and atopic dermatitis. Preliminary data is posted to the company's investor website. - Further development of AQST-108 will be addressed after Anafilm's U.S. NDA resubmission. ### Financing and Liquidity - Closed a $150 million multi-tranche debt facility with Oaktree Capital Management, which refinanced existing debt at a lower interest rate, pushed out principal payments for several years (saving $45 million in scheduled principal payments over the next three years), and satisfied pre-approval requirements for RTW Investments funding. - The facility includes: $55 million to refinance existing debt, $20 million accessible upon FDA approval of Anafilm, $25 million accessible upon meeting certain sales thresholds, and $50 million accessible via mutual consent of the company and Oaktree. - Combined with existing cash and RTW funding, the company projects it will have more than $150 million in cash at Anafilm launch (before any out-licensing proceeds for ex-U.S. Anafilm or U.S. Libervin). - Extended the RTW strategic funding agreement through June 30, 2027, extending liquidity runway. ### Commercial Preparation (U.S. Launch, if approved) - Preparations are on track, including plans for a 75-person sales force, strong medical affairs outreach, and targeted marketing. The company has studied the recent launch of a competing nasal epinephrine product and adjusted its strategy based on learnings. - Top priority is building trust and clarity with allergists to reduce practice friction and support patient access. Medical outreach includes plans to attend over 40 industry conferences and publish over 20 papers in 2026, which has already increased HCP awareness from 33% to 66%. ### Business Development - The business development team is in active negotiations for out-licensing deals across Europe, the U.S., and South America, with outreach from additional regions including China and Australia. Deals are prioritized by territory and program, with updates expected in coming months.

Guidance

- The company maintains guidance for an NDA resubmission of Anafilm to the FDA in Q3 2026, contingent on timely, expected feedback from the FDA on the human factors protocol. Top-line human factors data (and potentially PK data) for Anafilm is expected to be available in time for the August 2026 earnings call. - The company expects the resubmission will be classified as a Type 2 submission with a 6-month review timeline (final classification is determined by the FDA), and will request expedited review. Management notes FDA leadership's public focus on more timely reviews may create a possibility for a faster review process, though this cannot be guaranteed. - Full-year 2026 guidance is maintained at: total revenue of $46 million to $50 million, and non-GAAP adjusted EBITDA loss of $30 million to $35 million. No new full-year financial guidance is provided at this time, with updates tied to milestone achievement. - The company projects sufficient capital to complete remaining Anafilm studies, advance the pipeline, and fund operations through Anafilm launch (if approved) with the completed Oaktree and RTW financing structure. - Ex-U.S. marketing applications for Canada are targeted for 2026 submission; EU submission is targeted for late 2026 or early 2027.

Segment performance

Total revenues for Q1 2026 were $14.4 million, a 66% increase from $8.7 million in Q1 2025: - License and royalty revenue: $5.4 million (37.5% of total revenue), up from $0.8 million in Q1 2025. The increase is primarily driven by a one-time 10% royalty payment from Zebra following the sale of one of its products. - Manufacture and supply revenue: $8.8 million (61.1% of total revenue), up from $7.2 million in Q1 2025. The increase came from higher Suboxone revenues, partially offset by lower UNDIF revenues. Total operating expenses were $15.2 million in Q1 2026, down from $24.5 million in Q1 2025: - Research and development expenses: $4.2 million, down from $5.4 million in Q1 2025, due to lower clinical trial costs for Anafilm partially offset by higher personnel costs. - Selling, general, and administrative expenses: $11 million, down from $19.1 million in Q1 2025, driven by a one-time PDUFA fee in the prior year period, lower legal fees, lower commercial spending, and lower regulatory fees, partially offset by higher severance, personnel, and share-based compensation costs. Net loss for Q1 2026 was $8.1 million ($0.07 basic/diluted loss per share), compared to a net loss of $22.9 million ($0.24 basic/diluted loss per share) in Q1 2025. Non-GAAP adjusted EBITDA loss was $1.7 million in Q1 2026, compared to a $17.6 million loss in Q1 2025. The company ended Q1 2026 with $110 million in cash and cash equivalents.

Risks & headwinds

- Final FDA classification and review timeline for the Anafilm NDA resubmission is determined solely by the FDA, and expedited review is not guaranteed. Timely completion of required studies and the resubmission itself is contingent on FDA providing on-time, expected feedback on the human factors protocol, which may not occur. - Coverage and reimbursement for Anafilm (if approved) will take time to build, as is standard for new life science products, and there is no guarantee of broad, timely access for patients. - Early biomarker data for AQST-108 is directional only, not statistically powered, and further development will not move forward until Anafilm resubmission is complete. Clinical proof of efficacy and safety for AQST-108 has not been established, and the TSLP signal may not hold up in larger trials. - All pharmaceutical product development carries inherent risks of failure to gain regulatory approval, even after meeting all required study requirements.

Analyst Q&A

• Q: What gives management conviction that the Q3 2026 Anafilm resubmission timeline will be met, and how should investors contextualize the early AQST-108 TSLP biomarker signal? /

  A: Management has study designs finalized, trial sites on standby, and a completed financing structure to support the program, so all preparations are complete. The only remaining pending step is FDA review of the human factors protocol, which the FDA has committed to deliver in the next few weeks. For AQST-108, the TSLP signal impacts multiple inflammatory pathways relevant to a range of dermatologic indications, giving the program significant optionality. The early data is only directional, but it confirms the team is targeting the right biological mechanisms for the platform, demonstrating the potential value of the Adreniverse platform beyond Anafilm.

• Q: What steps is management taking to ensure patient access and reimbursement for Anafilm after approval, and how has extra time from the CRL improved launch preparation? /

  A: Management acknowledges coverage will take time to build, as it does for all new products. The team has learned from the recent competing nasal product launch and adjusted strategy to focus on reducing administrative friction for physician practices, investing in best-in-class patient and hub support services, and holding early robust discussions with PBMs and payers, which have shown significant interest in the product. The extra time has allowed for an aggressive medical awareness campaign: the company has attended 13 conferences to date (on track for over 40 in 2026) with 20 planned publications, which has steadily increased HCP awareness to 66% and built enthusiasm for the product among the allergy community.

• Q: What key learnings from the recent competing epinephrine product launch have changed Anafilm's commercial strategy, and does the completed Oaktree financing provide sufficient runway through Anafilm launch? /

  A: The Oaktree refinancing satisfied all pre-approval conditions for RTW funding, and the combined capital structure provides sufficient runway through launch if Anafilm is approved. The key learning from the competing launch is that even an innovative product cannot succeed without basic blocking and tackling: no launch success can be taken for granted. The team has adjusted strategy to prioritize reducing physician practice friction, focus sales outreach specifically on high-prescribing allergists and pediatricians with a 75-person sales force, and build credibility through scientific publications and medical outreach prior to launch. The team also plans to launch a program to give physicians direct real-world experience with Anafilm immediately after approval.

• Q: The Zebra royalty in Q1 was $5.4 million — is this a sustainable run rate, and how does AQST-108's topical delivery avoid the systemic safety risks of oral JAK inhibitors for alopecia? /

  A: The $5.4 million Q1 royalty is not a run rate: it reflects a one-time 10% payout from Zebra's sale of one of its products, so it will not recur at this level. Unlike JAK inhibitors that specifically block a single inflammatory pathway systemically, AQST-108 acts as a broad-based topical immunomodulator that only impacts elevated inflammatory markers in affected tissue, with no observed systemic absorption in Phase 1 testing. Normal healthy tissue with baseline inflammation was not impacted, which reduces the risk of systemic side effects seen with oral JAK inhibitors. Further data will be generated as the program advances after Anafilm resubmission.