Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Aquestive Therapeutics Inc (AQST, Financial) progressed its Anaphylm epinephrine Sublingual Film program and gained FDA approval for Libervant diazepam Buccal Film for the 2 to 5-year-old age group.
- The company successfully completed two of the three supportive studies necessary for engaging the FDA in a pre-NDA meeting for Anaphylm, with positive top-line data.
- Aquestive Therapeutics Inc (AQST) reported a 52% increase in total revenues year-over-year, driven by increases in license and royalty revenue.
- The company has $90 million in cash and cash equivalents as of June 30, 2024, providing a strong financial position to support ongoing development and commercialization efforts.
- Aquestive Therapeutics Inc (AQST) is expanding its commercial launch activities for Libervant, with national retail distribution capabilities expected by October 1 and a national sales team expansion in late Q3.
Negative Points
- Despite the revenue increase, excluding the one-time recognition of deferred revenue, total revenues actually decreased by 26% year-over-year.
- Research and development expenses increased significantly, from $3.5 million in Q2 2023 to $4.2 million in Q2 2024, primarily due to clinical trial costs and increased personnel costs.
- Selling, general, and administrative expenses also saw a substantial rise, increasing by 54% year-over-year, driven by higher personnel costs, share-based compensation, and regulatory fees.
- The net loss for the six months ended June 30, 2024, was $15.6 million, a significant increase compared to the net income of $2.3 million for the same period in 2023.
- The company terminated its US and China-based collaborations for Exservan, which had negligible revenue in 2023, indicating a strategic shift but also a potential loss of future revenue streams.
Q & A Highlights
Q: Could you talk a bit about your overall plan to target key physicians and hospital accounts for the upcoming launch of Anaphylm?
A: We are implementing a three-pronged strategy targeting high auto-injector prescribers, focusing on awareness, believability, and confidence to prescribe Anaphylm. This includes medical education, KOL interactions, market research, brand building, and payer decision-maker conversations to ensure affordable access.
Q: Could you remind us how the PD data tracked with the PK data in the recent temperature/pH and self-administration studies?
A: The pharmacodynamic data reflects the pharmacokinetic data consistently across our data set, including the temperature/pH and self-administration studies.
Q: Can you talk more specifically about the design of the pediatric study for Anaphylm?
A: The pediatric study aims to determine if the pharmacokinetic profile in children mirrors that of adults. We need to secure alignment with the FDA on using adult data to start the pediatric program.
Q: What is your long-term strategy for Libervant? Are you contemplating out-licensing it or keeping it?
A: Our mandate is to ensure patients have access to Libervant and to maximize our position. We are expanding a small sales team for now, but it could be distributed by another company in the future.
Q: Could you provide more detail on what you plan to discuss at the upcoming Investor Day, particularly regarding the Adrenaverse platform?
A: We will discuss the science behind the Adrenaverse platform, the specific indication for AQST-108, and potential future programs. We aim to show the broader potential beyond just Anaphylm.
Q: What are the components driving the updates to 2024 top-line guidance?
A: The increase in guidance includes the recognition of deferred revenue from terminated agreements, improved expectations for Suboxone demand, and additional spending on Libervant launch and Anaphylm pre-commercial activities.
Q: Are you anticipating an AdCom for Anaphylm like neffy had?
A: We can't predict the FDA's decision on an AdCom, but we believe our program continues to reduce risk. The outcome for neffy on October 2 will provide some regulatory read-through for us.
Q: How will you leverage the infrastructure built for Libervant for Anaphylm?
A: The infrastructure for Libervant, including salesforce and marketing, will provide synergies and a foundation for Anaphylm's launch. We are also considering potential partnerships for broader distribution.
Q: What is the gating factor to starting the Anaphylm pediatric study?
A: We need to ensure alignment with the FDA that the adult data set is sufficient to start the pediatric program. This will be a key discussion point in our pre-NDA meeting.
Q: Could you clarify the updated guidance for 2024 top-line and EBITDA, considering the non-cash deferred revenue?
A: The updated guidance includes the non-cash deferred revenue recognition. Excluding this, the guidance reflects increased expenses for Libervant launch and Anaphylm pre-commercial activities.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
