Yahoo Finance Aquestive Therapeutics Inc (AQST) Q1 2024 Earnings Call Transcript Highlights: Navigating ...
Total Revenue: Increased to $12.1 million in Q1 2024, up 8% year-over-year.
Net Loss: Reported at $12.8 million in Q1 2024, compared to net income of $8.1 million in Q1 2023.
Earnings Per Share: Loss of $0.17 per share in Q1 2024.
Research and Development Expenses: Rose to $5.9 million in Q1 2024 from $3.5 million in Q1 2023.
Selling, General, and Administrative Expenses: Increased to $10.7 million in Q1 2024 from $7.5 million in Q1 2023.
Non-GAAP Adjusted EBITDA Loss: $7.2 million in Q1 2024, compared to a loss of $3.9 million in Q1 2023.
Cash and Cash Equivalents: Stood at $95.2 million as of March 31, 2024.
2024 Revenue Guidance: Projected to be between $48 million and $51 million.
2024 Non-GAAP Adjusted EBITDA Loss Guidance: Expected to be between $22 million and $26 million.
Release Date: May 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Aquestive Therapeutics Inc (NASDAQ:AQST) announced positive Phase 3 results and a positive FDA interaction for Anaphylm, their lead product candidate.
Aquestive Therapeutics Inc (NASDAQ:AQST) successfully raised over $75 million in new capital from high-quality investors.
FDA approval was received for Libervant diazepam buccal film for treating seizure clusters in patients aged two to five years.
Aquestive Therapeutics Inc (NASDAQ:AQST) is progressing towards the NDA filing for Anaphylm, expecting to complete necessary studies by the end of the third quarter.
The company has begun typical launch activities for Anaphylm, including packaging design, marketing materials, and sales force planning.
Negative Points
Aquestive Therapeutics Inc (NASDAQ:AQST) faces a complex and competitive pharmaceutical distribution landscape, which requires significant preparation and innovation.
The company is still in the process of determining the optimal distribution model for Anaphylm, which involves navigating complex payer and market access landscapes.
Research and development expenses increased significantly, from $3.5 million in Q1 2023 to $5.9 million in Q1 2024, primarily due to the ongoing development of the Anaphylm program.
Selling, general, and administrative expenses also saw a substantial increase from $7.5 million in Q1 2023 to $10.7 million in Q1 2024.
Aquestive Therapeutics Inc (NASDAQ:AQST) reported a net loss of $12.8 million for Q1 2024, compared to a net income of $8.1 million in Q1 2023.
Q & A Highlights
Q: I wanted to pick your brain on the competitive landscape in the epi space. So there are a number of intranasal products, as you know, that are moving through development and wanted to get your thoughts on how you're thinking about not just the payer landscape in the context of a more crowded landscape but also just patient and practitioner preferences for nasal spray modality versus an oral film modality, so that's number one. A: Good morning, David. Good to hear your voice. So yes, in terms of the competitive landscape for epinephrine, I will admit I have lost count of how many intranasals are in development. But I know there are a number of them. But as far as I'm aware, and what -- just as excited and where we think we are unique is we are the only oral. We are what we believe is a very portable product. And we're the only product that I'm aware of that is bio comparable to the auto-injectors for the first 30 minutes following administration.
Q: Hey, thanks for the question. So I was just wondering if you can comment on the allergen test now that it seems to be the requirement and the cancellation of the angioedema test that you initially thought you would have to run. Is that is that helpful? Can you help us just contextualize what that means to the company if it's easier or harder? And angioedema in the real world, how common do you see this with anaphylaxis here? Thank you. A: Good morning, Frank. Good to hear your voice yet. I'm glad you brought up this topic because in our view, there appears to be some confusion that's out in the in the world around edema and what is experienced by someone going through the process of anaphylaxis.
Q: Thanks very much for taking my questions. Firstly, with respect to the timeline for the submission of the Anaphylm NDA, based on your current objectives with respect to the pre-NDA meeting, can you confirm whether you still expect to submit the NDA before the end of this year or if it's possible that it could slip into next year simply because of the lag between concluding the pre-NDA meeting and completing the final pediatric study? A: Good morning, Ram. And I'm glad you brought that up because there was -- in our prepared remarks and in the supplemental materials we've given, we did show everyone something a little different than last time, and I want to make sure we're clear with everyone what that difference is.
Q: Good morning. This is Jose for Jason. Thanks for taking our question. Just a very quick one, follow up clarifying question. Is a pediatric trial needed for approval or do you plan to include the safety data from this study to FDA during the NDA review? For the temperature/pH trials, we're just wondering, what are you expecting to share? And lastly, on the topical products, do you also need to look at the potential of accidental exposure to another person, whether it's another subject, a healthcare provider, or a family member? Thank you. A: So I apologize. You were very soft coming through. I think I captured some of it, but not all of it. I heard you ask on the temperature/pH study, when -- what our thoughts are in sharing data. I heard you ask on the topical products, I think a sizing question about what the opportunity looks like. Then I missed one of the other questions.
Q: Thanks, guys. Good morning. So first on Anaphylm, and just to follow up, I think it was just asked but not answered. So on the pre-NDA meeting and the pediatric study, is there a scenario where you would file for just adults without that pediatric study? As far as -- just a question of confirming the design of that pediatric study that you laid out, I'm assuming 7 to 17 is a big portion of the market that you need in the filing. A: Good morning, Gary. And I will admit to being disappointed you didn't ask a Libervant question since you've been with us on Libervant for quite some time.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
