Aquestive Therapeutics, Inc. (AQST) Earnings

Management highlights

### Anafilm Development Progress - All required studies for the Anafilm NDA resubmission are complete, and the company remains on track to resubmit by the end of Q3 2026, less than 8 months after receiving an FDA Complete Response Letter (CRL). - Updated human factors validation study results showed a dramatic reduction in errors from the original submission: only 1 participant had difficulty opening the new packaging (down from 26 previously) and 0 participants tore the film (down from 6 previously); only 2 participants misplaces the dose (down from 20 previously). - New pharmacokinetic (PK) study confirmed no statistical difference between clinician-administered and uncoached self-administered doses using the revised packaging/instructions. Even in the FDA-requested purposely misplaced dose scenario, Anafilm produced clinically meaningful PK levels and pharmacodynamic (PD) responses that compared favorably to manual IM epinephrine. ### Commercial Opportunity & Launch Preparation - The U.S. epinephrine rescue market is growing 6% annually, with a current branded market opportunity estimated to exceed $1 billion annually, with potential to reach $2 billion over time. - Unmet need for an improved product is high: patients and caregivers consistently report dissatisfaction with autoinjectors for difficulty of use, portability, and needle anxiety. Management believes clinical differentiation, not just needle-free delivery, will drive payer and provider adoption. - Launch preparations are fully complete and on track: regional sales team hiring and training plans are finalized, marketing materials are prepared consistent with pre-approval regulations, and commercial analytics capabilities are being built out. The launch strategy will focus initially on allergists to control cash burn while driving adoption. - The company expects to access $75 million in launch funding from RTW and $20 million from Oaktree upon FDA approval of Anafilm. ### Pipeline & Business Development - The AQST-108 topical epinephrine program for atopic dermatitis is being advanced after Anafilm resubmission. Preclinical and early data supports a profile that would position AQST-108 between low-cost ineffective generics and high-priced biologics. Additional scientific details are included in supplemental call materials. - Active partnering processes are ongoing for Liberbin (U.S.) and Anafilm (ex-U.S.), with updates expected as negotiations progress. - Base business (including legacy Suboxone supply activities) remains consistently cash flow positive, with no expected near-term impact from the proposed Indivior-Saphnis merger. - The company completed a refinancing with Oaktree, establishing a new $150 million debt facility that lowers cost of capital, extends the interest-only period, and improves financial flexibility for a potential Anafilm launch.

Guidance

- The company maintained its full year 2026 financial guidance: - Total annual revenue is expected to be between $46 million and $50 million - Full year 2026 non-GAAP adjusted EBITDA loss is expected to be between $30 million and $35 million - Management reaffirmed guidance that Anafilm NDA resubmission will be completed in Q3 2026 - Per FDA classification rules, a standard 6-month review period is the base case expectation for the resubmission, but management is pursuing a shorter accelerated review timeline with the FDA, as the resubmission is narrowly focused on addressing the CRL comments and builds on prior FDA review of the full NDA - Ex-U.S. regulatory filings for Anafilm (Canada, EU, UK) are planned to begin in Q4 2026 - Additional updates on the AQST-108 atopic dermatitis program will be provided after Anafilm resubmission is completed, later in 2026

Segment performance

Acquistive Therapeutics (Equestive) reports the following segment performance for Q2 2026: - Total revenue: $13.8 million (up 38% year-over-year from $10.0 million in Q2 2025). For the first half of 2026, total revenue reached $28.3 million (up 51% year-over-year from $18.7 million in H1 2025). - Manufacture and supply revenue: $11.9 million in Q2 2026 (86.2% of total Q2 revenue), up from $9.6 million in Q2 2025. The increase was driven by higher Suboxone revenues, partially offset by lower ONDIF revenues. For H1 2026, manufacture and supply revenue was $20.7 million (73.1% of total H1 revenue), up from $16.8 million in H1 2025. - License and royalty revenue: $1.3 million in Q2 2026 (9.4% of total Q2 revenue), up from $0.8 million in Q2 2025, driven by royalty revenue from ZEVRA. For H1 2026, license and royalty revenue was $6.7 million (23.7% of total H1 revenue), up from $1.6 million in H1 2025, also driven by ZEVRA royalties. Operating expense breakdown: - Research and development (R&D) expenses: $4.0 million in Q2 2026 (down slightly from $4.1 million in Q2 2025); $8.2 million for H1 2026 (down from $9.5 million in H1 2025). The decrease reflects lower Anafilm clinical and manufacturing costs, partially offset by higher preclinical costs for pipeline programs. - Selling, general, and administrative (SG&A) expenses: $14.1 million in Q2 2026 (up from $12.7 million in Q2 2025); $25.0 million for H1 2026 (down from $31.8 million in H1 2025). The year-to-date decrease reflects lower commercial spending, the absence of the prior year's one-time Anafilm PDUFA fee, and lower regulatory fees, partially offset by higher severance and personnel costs. Net results: Q2 2026 GAAP net loss was $22.9 million ($0.18 loss per share), compared to a $13.5 million net loss ($0.14 loss per share) in Q2 2025. Excluding a one-time $11.7 million loss on debt extinguishment from refinancing, adjusted net loss was $11.2 million. Non-GAAP adjusted EBITDA loss was $5.2 million in Q2 2026, compared to a $9.3 million loss in Q2 2025. The company ended Q2 2026 with $98.5 million in cash and cash equivalents.

Risks & headwinds

- As a clinical-stage pharmaceutical company with a lead product candidate under regulatory review, there is significant uncertainty regarding FDA approval of Anafilm. Even with positive study data addressing the prior CRL, the FDA may still reject the resubmission or require additional studies. - Commercial adoption and payer coverage for Anafilm is not guaranteed, even if approved. The epinephrine rescue market is currently dominated by generic autoinjectors, and the company's ability to capture meaningful market share depends on successful provider conversion and favorable payer formulary placement. - There is uncertainty regarding the FDA's decision on review timeline for the Anafilm resubmission; a 6-month review is the base case, but a longer review could delay potential launch and increase cash burn. - Early-stage pipeline programs including AQST-108 carry inherent development and regulatory risk, and preclinical and early clinical signals may not translate to successful clinical trials or regulatory approval. - The company's base business relies partially on legacy Suboxone supply relationships with Indivior, and the proposed Indivior-Saphnis merger could create unanticipated future changes to this revenue stream.

Analyst Q&A

• Q: How do the new PK and human factors data increase confidence in the resubmission, and what review timeframe does the company expect? /

  A: The original CRL only cited issues with packaging opening and administration instructions, and the FDA had already signed off on the clinical efficacy/safety of Anafilm. The new study results thoroughly and convincingly addressed all FDA concerns, with clean, strong data that even showed clinically meaningful effect in the purposely misdosed scenario. The standard FDA classification calls for a 6-month review, which is the company's base case. Management will make a supportive case for a faster review given the narrow, focused scope of the resubmission, but the final decision rests with the FDA.

• Q: For the purposely misplaced top-of-tongue dose scenario, did the FDA set a CMAX bar, and what key clinical differentiation will the company highlight to payers? /

  A: The FDA had previously pointed to two PK thresholds: 50 picograms per milliliter and 100 picograms per milliliter, and Anafilm meets both even for the off-label misplacement scenario. The key clinical differentiation Anafilm offers over existing autoinjectors is faster onset of action and greater magnitude of effect within the critical 5-10 minute window after anaphylaxis onset, which is far more meaningful to providers and payers than just the needle-free profile.

• Q: What is the rationale for developing AQST-108 for atopic dermatitis first, and what early data supports the program? /

  A: Atopic dermatitis is a well-established entry point for new dermatology therapies, and provides a clear first proof of concept before expanding to other indications like alopecia areata. Preclinical data shows that topical AQST-108 suppresses key inflammatory drivers of atopic dermatitis itch (IL-31, TSLP), and has a novel slow-release local delivery profile. The company remains focused on Anafilm resubmission first, with more updates coming later in 2026.

• Q: Will the Anafilm resubmission be Class 1 (2-month) or Class 2 (6-month), and how will the company drive patient switching from existing autoinjector prescriptions? /

  A: FDA classification is at the agency's discretion, but the narrow focused scope of the resubmission makes a streamlined review appropriate. For switching, patients are required to see their allergist annually for a new prescription, so the allergist-focused launch strategy will target these annual check-in conversations. The strong clinical differentiation and unmet need for a better product provides a compelling switch story to both providers and patients.

• Q: How is the commercial team prepared for variable review timelines, and what is the long-term strategy for the Adreniverse platform? /

  A: The CRL provided extra time to refine launch plans, and multiple scenario plans are already in place for both 2-month and 6-month review timelines. Sales rep contingent offers will be finalized once the FDA confirms the review timeline to avoid unnecessary carrying costs. Long-term, the company plans to build out an internal pipeline and commercial presence for Adreniverse: Anafilm establishes the company in allergy, and AQST-108 can expand into dermatology, which shares overlapping practice networks with allergy.