Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Aquestive Therapeutics Inc (AQST, Financial) is in the commercial prelaunch phase for Anaphylm, a potentially transformative oral medication for severe allergic reactions, with FDA approval anticipated in early 2026.
- The company has assembled a strong marketing team with experience in building successful brands like EpiPen, positioning them well for a successful launch.
- Aquestive has established significant relationships with national allergy advocacy groups and is actively involved in shaping legislative actions to ensure patient access to epinephrine products.
- The company has a robust prelaunch awareness platform, having attended numerous conferences and published multiple posters and manuscripts to increase awareness among healthcare professionals.
- Aquestive's in-house manufacturing capabilities ensure readiness for product launch, with plans in place to have Anaphylm available on day one of approval.
Negative Points
- Total revenues decreased by 28% in the first quarter of 2025 compared to the same period in 2024, primarily due to declines in manufacture and supply revenue and license and royalty revenue.
- The company reported a net loss of $22.9 million for the first quarter of 2025, an increase from the $12.8 million loss in the first quarter of 2024.
- Selling, general, and administrative expenses increased significantly, driven by regulatory fees, legal fees, and higher commercial spending.
- Aquestive has paused sales and marketing activities for Libervant, impacting revenue guidance for 2025.
- The company acknowledges the need to strengthen its balance sheet ahead of the Anaphylm launch, indicating potential financial challenges in supporting the launch without additional capital.
Q & A Highlights
Q: Can you update us on your commercial readiness efforts for Anaphylm, including CMC and manufacturing scale-up? Also, what are your goals for hiring a field force for Anaphylm?
A: (Daniel Barber, CEO) We have in-house manufacturing capabilities, and CMC and manufacturing scale-up are well within our capabilities. We are prepared to have products ready to go on day one. (Sherry Korczynski, SVP of Sales and Marketing) We plan to start with around 50 sales representatives focusing on top Anaphylm prescribers, including about 4,000 to 5,000 allergists and pediatricians.
Q: What are your key goals in interacting with payers to set up broader favorable access for Anaphylm, and what are the timelines for setting up this access?
A: (Daniel Barber, CEO) We will leverage existing contracts from our work with Libervant for distribution and payer access. (Sherry Korczynski, SVP of Sales and Marketing) We aim to have upwards of 80% coverage by the end of the first six months post-launch, aligning with the back-to-school season.
Q: Can you talk about any learnings from the launch of neffy and how it might impact Anaphylm? Also, what are your thoughts on a potential Ad Comm?
A: (Daniel Barber, CEO) We see market expansion occurring as expected, with volumes up 5% year-over-year. We expect the market to double in the coming years. (Carl Kraus, CMO) We are prepared for an Ad Comm and have a robust data set to support Anaphylm.
Q: How do you envision the division head for pulmonology allergy space influencing the Ad Comm and review process?
A: (Daniel Barber, CEO) Our interactions have been with the Deputy Director, and the review team remains the same. We are ready for an Ad Comm and hope it happens, but we have some doubts about the government's ability to facilitate it.
Q: What are your thoughts on direct-to-consumer advertising strategies for Anaphylm, and when would you deploy them?
A: (Daniel Barber, CEO) DTC is important for awareness, especially in this market. We believe it helps drive awareness and patient engagement. (Sherry Korczynski, SVP of Sales and Marketing) Initially, we will focus on HCP promotion, then layer in DTC as market access coverage increases, similar to our competitors.
Q: Can you describe the distribution infrastructure for Anaphylm in the US and your strategy for optimizing opportunities outside the US?
A: (Daniel Barber, CEO) We see opportunities in Canada, the UK, and Germany and are engaging with regulatory bodies there. (Sherry Korczynski, SVP of Sales and Marketing) Anaphylm will be available through retail channels like CVS and Walgreens, with potential alternate distribution models.
Q: For Anaphylm ex US, would you want a partner to handle regulatory submissions, and what does the ideal early adopter prescriber look like?
A: (Daniel Barber, CEO) The regulatory submission strategy is partner-dependent, but we have the capability to support it. (Sherry Korczynski, SVP of Sales and Marketing) Early adopters will likely be physicians hearing from patients about the need for a non-device option, with 95% of physicians seeing a film dosing option as filling an unmet need.
Q: How much cash do you believe you'll need for the launch of Anaphylm, and what are your plans for AQST-108?
A: (Daniel Barber, CEO) We have several paths to finance the launch, including partnerships and debt refinancing. We are pausing AQST-108 to focus resources on Anaphylm but remain committed to its potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
