Release Date: November 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Aquestive Therapeutics Inc (AQST, Financial) announced a major new product candidate, AQST-108, for alopecia areata, expanding their pipeline.
- The company completed a final adult study for their Anaphylm program and submitted a pre-NDA briefing book to the FDA, indicating progress towards regulatory approval.
- Libervant has achieved Medicaid coverage in all 50 states and agreements with two of the top three PBMs, enhancing market access.
- The OASIS study showed promising results for Anaphylm, with significant reduction in symptom resolution time, potentially differentiating it in the market.
- Aquestive Therapeutics Inc (AQST) reported a 22% increase in total revenues for the first nine months of 2024 compared to the same period in 2023, driven by licensing and royalty revenue.
Negative Points
- Despite revenue growth, the company reported a net loss of $11.5 million for the third quarter of 2024, an increase from the previous year.
- Research and development expenses increased significantly, driven by clinical trial costs and share-based compensation, impacting profitability.
- Selling, general, and administrative expenses rose due to increased commercial spending and regulatory fees, contributing to the net loss.
- The company faces uncertainties related to the regulatory approval and commercialization of its products, which could impact future performance.
- Legacy revenue streams, such as Suboxone, face potential dislocation due to market competition, posing a risk to future cash flow.
Q & A Highlights
Q: What topics did you highlight most to the FDA in the Anaphylm clinical briefing book, and what were your main goals?
A: Daniel Barber, CEO: We aimed to demonstrate that we have met all FDA requirements and that our results are positive. We seek FDA guidance on the completeness of our package and believe we are well-positioned for the upcoming meeting.
Q: How did the initial negotiations go with the first two PBMs for Libervant?
A: Sherry Korczynski, SVP of Sales and Marketing: Negotiations have been positive. Libervant is being covered for patients aged 2 to 5, and there is significant unmet need in the market, making it a game changer for physicians and payers.
Q: Are you preparing for an advisory committee (ad com) for Anaphylm, given past experiences?
A: Carl Kraus, Chief Medical Officer: While we can't predict FDA actions, we have mitigated risks and met all primary and secondary endpoints. We are prepared for an ad com if the FDA pursues that route.
Q: How does the OASIS study impact real-world adoption of Anaphylm by doctors?
A: Carl Kraus, Chief Medical Officer: The study indicates that delivering epinephrine into the oral cavity holds promise for interrupting anaphylactic cycles. The data is seen as a differentiator and has garnered attention from physicians.
Q: What is the pricing paradigm for Libervant compared to Valtoco, and how does it affect future adult population introduction?
A: Daniel Barber, CEO: We haven't found price to be an obstacle for Libervant. We believe the payer community understands the necessity of the product, and we expect pricing dynamics to remain consistent when we access the full market.
Q: How are you preparing for the Anaphylm launch, considering Nephi's presence in the market?
A: Sherry Korczynski, SVP of Sales and Marketing: We are conducting market research to identify high-value prescribers. Anaphylm is seen as a game changer due to its ease of use and carry, and we believe it will be preferred by newly diagnosed patients and those avoiding allergens.
Q: What is the expected shelf life for Anaphylm, and how does it compare to Nephi?
A: Daniel Barber, CEO: We focus on real-world usability, ensuring the product works through daily life changes. While we haven't disclosed specific data, we plan to make our shelf life robust to meet patient needs.
Q: How confident are you in the FDA's alignment on the AQST-108 phase 2a study design for alopecia areata?
A: Carl Kraus, Chief Medical Officer: We rely on published data from similar studies and believe the FDA will view our endpoints as reasonable. We expect the study design to be well-received.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
