Aquestive Therapeutics, Inc. ((AQST)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Aquestive Therapeutics, Inc. recently held an earnings call that highlighted a mix of optimism and challenges. The company expressed positive sentiment regarding its strategic progress towards the FDA approval of Anaphylm and significant financing achievements. However, financial challenges such as an increased net loss and decreased revenue underscore ongoing operational hurdles.
Anaphylm FDA Approval Progress
The company is making strides towards the FDA approval of Anaphylm, with the FDA confirming an on-time review and no need for an Advisory Committee meeting. This positions Aquestive well for a potential launch in the first quarter of 2026, signaling a significant milestone for the company.
Successful Financing Rounds
Aquestive has successfully completed an $85 million equity raise and a $75 million commercial launch financing. These efforts provide the company with capital support through 2027, ensuring financial stability as it prepares for the launch of Anaphylm.
Increased Market Awareness and Engagement
The company has made notable progress in increasing market awareness and engagement for Anaphylm. Most allergists are aware of the product, with over 25% having completed CME presentations, indicating strong prelaunch engagement and interest.
International Expansion Plans
Aquestive is also focusing on international expansion, with positive interactions with Health Canada allowing for filing in the first half of 2026. Additionally, ongoing discussions with the European Medicines Agency are paving the way for European approval.
Net Loss Increase
The company reported a net loss of $15.4 million for the third quarter of 2025, up from $11.5 million in the same period of 2024. This increase highlights the financial challenges the company is facing as it invests in its strategic initiatives.
Decline in Total Revenues
Total revenues decreased to $12.8 million in Q3 2025 from $13.5 million in Q3 2024, primarily due to a one-time deferred revenue recognition in the prior year. This decline reflects the financial pressures the company is navigating.
Increased Operating Expenses
Operating expenses rose to $15.3 million in Q3 2025, driven by pre-commercial spending and higher legal and regulatory fees. This increase is part of the company’s strategic investments in preparation for Anaphylm’s launch.
Research and Development Cost Reduction
Interestingly, research and development expenses decreased to $4.5 million in Q3 2025, mainly due to lower clinical trial costs. This reduction may indicate a shift in focus or constrained R&D activities.
Forward-Looking Guidance
Aquestive is gearing up for the potential FDA approval of Anaphylm, with a PDUFA date set for January 31, 2026. The company plans to launch in Q1 2026, contingent on FDA approval, and has prepared its supply chain and marketing materials. Despite a net loss, Aquestive remains optimistic about its financial outlook and strategic initiatives, including advancing its Adrenaverse platform and AQST-108 program for alopecia areata.
In conclusion, Aquestive Therapeutics’ earnings call painted a picture of strategic progress and financial challenges. While the company is optimistic about Anaphylm’s FDA approval and its financing achievements, it continues to face operational hurdles. Investors will be keenly watching the company’s next steps as it approaches critical milestones in its growth trajectory.