AQST Q2 2026 Earnings Call Summary

1Key Financial Results and Metrics

Total Revenues: Increased to $13.8 million in Q2 2026 from $10 million in Q2 2025, a 38% year-over-year growth.

Manufacture and Supply Revenue: Rose to $11.9 million from $9.6 million, driven by increased Suboxone revenues.

License and Royalty Revenue: Increased to $1.3 million from $0.8 million, primarily due to royalties from Zevra.

Net Loss: Reported at $22.9 million ($0.18 per share) compared to $13.5 million ($0.14 per share) in Q2 2025. Excluding a one-time debt extinguishment loss, the adjusted net loss was $11.2 million.

Cash Position: Ended Q2 with $98.5 million in cash and equivalents, supported by a new $150 million debt facility from Oaktree.

Non-GAAP Adjusted EBITDA Loss: Improved to $5.2 million from $9.3 million in Q2 2025.

2Strategic Updates and Business Highlights

Anaphylm Resubmission: Planned for Q3 2026, with completed studies showing significant improvements in human factors and pharmacokinetics (PK).

Market Opportunity: The epinephrine market is projected to exceed $1 billion annually, with potential growth to $2 billion. The company aims to differentiate Anaphylm through ease of use and clinical efficacy.

Launch Preparations: The commercial team is actively preparing for a potential launch, focusing on allergists to drive adoption.

AQST-108 Development: The company is exploring a topical epinephrine product for atopic dermatitis, leveraging insights from previous studies.

3Forward Guidance and Outlook

2026 Revenue Guidance: Expected total revenue of $46 million to $50 million, with a non-GAAP adjusted EBITDA loss of $35 million to $30 million.

Launch Funding: Anticipated $75 million from RTW and $20 million from Oaktree following FDA approval of Anaphylm.

4Bad News, Challenges, or Points of Concern

Increased Losses: The net loss has widened compared to the previous year, raising concerns about cash burn as the company prepares for launch.

Regulatory Risks: The FDA's review process remains uncertain, and while the company is optimistic about a streamlined review, there is no guarantee of expedited approval.

Competitive Pressures: The market for epinephrine is dominated by generic products, and the company faces challenges in converting users from established auto-injectors to Anaphylm.

5Notable Q&A Insights

FDA Review Timeline: Management indicated a standard 6-month review for the resubmission but expressed hope for a faster timeline based on the focused nature of the new submission.

Clinical Differentiation: There is strong confidence in the clinical data supporting Anaphylm, particularly regarding its rapid onset and effectiveness compared to existing treatments.

Market Strategy: The company plans to leverage strong clinical data to engage with payers and allergists, emphasizing the product's unique benefits.

Partnership Opportunities: Active discussions are ongoing for potential partnerships related to Libervant in the U.S. and Anaphylm internationally. Overall, Aquestive Therapeutics is positioned for potential growth with its upcoming Anaphylm resubmission and ongoing development of AQST-108, despite facing challenges related to financial losses and regulatory uncertainties.