Aquestive Therapeutics Q4 2025 Earnings Call Transcript

Quartr
Provided by Quartr
March 5, 2026

Key Takeaways

  • Positive Sentiment: Aquestive says it has a clear FDA path — a Type A meeting and briefing book have been submitted (meeting expected within ~30 days), CROs are selected and human factors and PK studies are underway with a planned NDA resubmission in Q3 2026.
  • Positive Sentiment: Commercial and financing preparedness improved — the company plans to launch with 75 sales reps (50% more than prior guidance) and secured an extension of RTW revenue‑interest financing (unchanged $75M facility) plus a $5M strategic investment to support a potential launch.
  • Neutral Sentiment: Financial runway and 2026 outlook — Aquestive ended 2025 with $121.2M cash, is guiding 2026 revenue of $46–50M and a non‑GAAP adjusted EBITDA loss of $30–35M, and expects to finish 2026 with ~ $70M cash excluding additional RTW or out‑licensing proceeds.
  • Negative Sentiment: Rising costs and losses — SG&A rose sharply (including ~ $14M of one‑time legal expenses and higher pre‑commercial spending), and full‑year net loss widened materially (2025 net loss of $83.8M including legal; $70.6M excluding one‑time legal), increasing near‑term cash burn risk.
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Earnings Conference Call
Aquestive Therapeutics Q4 2025
00:00 / 00:00

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Operator

Good day, and thank you for standing by. Welcome to Aquestive Therapeutics fourth quarter 2025 conference call. At this time, all participants are on a listen only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to speaker host for today, Faith Pomeroy-Ward. Please go ahead.

Faith Pomeroy-Ward
Marketing, PR, and Corporate Communications at Allergy & Asthma Network

Thank you, operator. Good morning and welcome to today's call. On today's call, I'm joined by Daniel Barber, President and Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the fourth quarter and full year ended December 31st, 2025, and a progress update on the company's key 2026 objectives, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Matt Greenhawt, Chief Medical Officer, Melina T. Cioffi, Senior Vice President, Regulatory Affairs, Sherry Korczynski, Chief Commercial Officer, and Dr. Matthew Davis, Chief Development Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday.

Faith Pomeroy-Ward
Marketing, PR, and Corporate Communications at Allergy & Asthma Network

A recording of today's call and related supplemental materials will be made available on Aquestive's website within the investors section shortly following the conclusion of this call. To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of fourth quarter and year-end 2025 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the investors section of Aquestive's website. During the call, the company will be making forward-looking statements.

Faith Pomeroy-Ward
Marketing, PR, and Corporate Communications at Allergy & Asthma Network

We remind you of the company's safe harbor language as outlined in today's earnings release, as well as the risks and uncertainties affecting the company as described in the Risk Factors section and in other sections included in the company's annual report on Form 10-K, filed with the U.S. Securities and Exchange Commission on March 4th, 2026. With any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements.

Faith Pomeroy-Ward
Marketing, PR, and Corporate Communications at Allergy & Asthma Network

All forward-looking statements attributable to Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. I would like to turn the call over to Dan.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Thanks, Faith. Good morning, everyone, and thank you for joining us. Today, my message to you is simple and clear. This is a great moment in Aquestive's evolution, and I'm filled with optimism for our future. I am filled with optimism because I believe our path has never been clearer. I believe our risk profile has never been lower, and I believe our transparency allows all of you to see this as well. Let me walk you through where we are today on bringing Anaphylm to market here in the U.S. as well as around the world. We believe we have a very clear and achievable set of instructions from the FDA on resubmission of our NDA. We have submitted our Type A meeting request and expect to have a discussion with the FDA within the next 30 days.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

We have already selected our clinical research organizations for both the human factors study and PK study and continue to prepare for dosing. We are agreeing to everything the FDA requested with one minor clarification on the arms required for the PK study. We have already modified our packaging to make the pouch easier to open, and this has no impact on stability or durability. We are reiterating today our commitment to filing our resubmission in the third quarter of this year. You can also find more specific details on our program, including pictures of the revised packaging in our supplemental materials found on our website. While it's great to have a clear path and plan, you also need the right team, and I am fortunate that we have a fantastic development team here at Aquestive. With the recent addition of Dr.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Matt Greenhawt, a world-renowned allergist, and this year's recipient of the prestigious Distinguished Clinician Award by the American Academy of Allergy, Asthma & Immunology, or AAAAI, and the addition late last year of Dr. Matthew Davis, a seasoned development leader from large established organizations, we have the clinical expertise to efficiently conduct our development studies, interact effectively with the FDA, and appropriately inform the medical community of our clinical results. This is by far the strongest clinical team Aquestive has ever had. In fact, it will be important that we get our scientific and medical information out to the community as broadly and deeply as possible this year. That is why, in addition to Dr. Greenhawt joining us, we are more than doubling the size of our medical affairs organization.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

This will allow us to attend more conferences, educate more physicians on our data, and provide the community with more scientific publications in the coming months. This clinical and medical prowess also aligns with our work outside the U.S. We remain on track to file in Europe and Canada before the end of the year. We also will be meeting with the U.K. Health Authority, known as MHRA, in the coming weeks. We are confident that Anaphylm can benefit all humans, and we want to expand access to our product outside of the U.S. as rapidly as possible. Let's turn to the commercial side. Launching a prescription drug in the U.S. is extremely difficult. It requires considerable capital, patience to work through the complexities of the payer world, and significant marketing efforts across a variety of channels. Similar to development, this takes having the right people.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

As you may recall from my comments a month ago, Sherry Korczynski, our Chief Commercial Officer, and I made the decision to keep the core commercial leadership team intact following our CRL. That team continues to do great work and prepare for launch. This extra preparation time allows us to think bigger, and we are guiding today that we will launch with 50% more sales reps upon approval compared to our previous guidance. This means we expect to have 75 reps at launch versus the previous guidance of 50. Our planning process indicates we should be able to do this from a close to cash neutral position by the end of 2027. Speaking of cash, as stated before, launching a drug takes tremendous amounts of capital. Accessing this capital means making sure you have the right investors who believe in your product, your story, and your team.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

That's why we were excited to announce today that RTW has extended their revenue sharing agreement with us to consummate at any time before June 30th, 2027, and has also agreed to invest additional capital in the company. We appreciate the faith put in us by the RTW team and like all of our investors and shareholders, take this responsibility seriously. This, along with our cash guidance that Ernie will discuss in a few minutes, we believe positions us well for a potential launch. In terms of the underlying allergy market, we continue to see overall prescription growth. EpiPen and generic auto-injectors grew by approximately 5% in Q4 2025, and the overall market grew by just over 9%. Importantly, we also continue to see a market that seems to be waiting for the first oral epinephrine product.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Over 90% of prescriptions remain with auto-injectors. Obviously, the entire market continues to use medical devices. As I've stated in the past, we believe seeing is believing with our oral medication. When patients have the physical film in front of them, our data indicates they will almost always choose the film over auto-injectors and nasal sprays. Given the potential near term launch of Anaphylm in the U.S., if approved by the FDA, we will continue to both simplify and grow our overall business where possible. From a litigation standpoint, this means we will continue to seek ways to simplify our workload while also appropriately defending our business. In December, we reached a settlement agreement in a nine-year-long defamation lawsuit brought by a competitor. I am pleased to remove this distraction from the business.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

This marks the fourth lawsuit we have been able to have withdrawn, get thrown out of court, or reasonably settled over the last four years. We are also guiding that due to the timing of a potential Anaphylm launch, our initial focus with Libervant will be licensing the product in the U.S. We have several parties already interested and actively engaged in discussions. We will keep you updated on this as the year progresses. We continue to believe Libervant is a tremendous product that can meaningfully improve patients' lives. We also note that the two nasal spray products available for the treatment of seizure clusters are forecasted to exceed over $400 million in sales this upcoming year. We continue to progress nicely with multiple parties in Europe for a license of Anaphylm and expect to use a licensing approach for that market.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Finally, we also have our eyes towards the long-term future of the company. We continue to believe in a long-term multi-product potential of AdrenaVerse, our prodrug epinephrine platform. We successfully opened an IND for AQST-108 in December 2025, completed dosing of our initial safety study last month, and expect to have top-line clinical data in the near future. We will keep you informed on this program as we move forward. In summary, now is a great time for Aquestive. We have a clear path to market for Anaphylm. We have a clear path to the necessary capital to launch Anaphylm, if approved by the FDA. We have the right clinical, regulatory, and commercial leaders to effectively execute on our strategy. We are focused on out-licensing activities for Libervant and ex-US for Anaphylm, and we continue to progress our long-term pipeline. I will turn the call over to Ernie.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Thank you, Dan, and good morning, everyone. By now, you have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the 4th quarter 2025 and full year 2025 results in the Q&A. During 2025, we made great progress in positioning Aquestive for future success, including submitting the NDA for Anaphylm, the first and only non-invasive orally delivered epinephrine product if approved by the FDA. Closing an $85 million equity raise from high-quality institutional healthcare investors, secured $75 million in revenue interest financing from RTW upon approval of Anaphylm, and ended 2025 with $121 million with cash runway to support costs associated in preparing for the Anaphylm NDA resubmission, including the new human factors validation study and supportive PK study.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Pre-commercial infrastructure costs to increase awareness of Anaphylm through the execution of its medical affairs strategy, including presenting scientific data at medical forums throughout 2026, planned regulatory submissions in Canada and in the EU, and the AQST-108 Phase 1 clinical trial. As outlined in the press release issued last night after market close, we announced an extension until June 30th, 2027 of our agreement with RTW. This extension secures the availability of the revenue interest financing to support the commercial launch of Anaphylm, if approved by the FDA. RTW has also agreed to an additional strategic investment of $5 million in Aquestive, showing continued confidence in the company. Now, let's turn to the recap of our quarterly and full-year financial results. Total revenues increased to $13 million in the fourth quarter 2025 from $11.9 million in the fourth quarter 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

This 10% increase in revenue was primarily driven by increases in manufacture and supply revenue. Manufacture and supply revenue increased to $12 million in the fourth quarter 2025 from $10.7 million in the fourth quarter 2024, primarily due to increases in Suboxone revenues and Ondif revenues. Excluding the impact of one-time recognition of deferred revenues during the full year 2024, total revenues decreased by $1.5 million or 3% to $44.5 million for the full year 2025. As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $44.5 million for the full year 2025 from $57.6 million for the full year 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Manufacture and supply revenue increased to $40.2 million for the full year 2025 from $40 million for the full year 2024, primarily due to increases in Ondif revenues, partially offset by decreases in Suboxone revenues. R&D expenses decreased to $3.2 million in the fourth quarter 2025 from $4.9 million in the fourth quarter 2024. The decrease in R&D expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the Anaphylm development program and a decrease in share-based compensation. R&D expenses decreased to $17.2 million for the full year 2025 from $20.3 million in the full year 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

The decrease in R&D expenses was primarily due to lower clinical trial costs associated with the continued advancement of the Anaphylm development program, partially offset by increases in product research expenses and share-based compensation. Excluding one-time legal expenses, selling general and administrative expenses increased to $19.6 million in the fourth quarter 2025 from $16 million in the fourth quarter 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Including the one-time legal expenses, selling, general and administrative expenses increased to $32.8 million in the fourth quarter 2025 from $16 million in the fourth quarter 2024, primarily due to higher legal expenses of approximately $13.6 million, higher commercial spending of approximately $3.7 million in preparation for the launch of Anaphylm. Higher personnel expenses of approximately $0.8 million and higher share-based compensation of approximately $0.2 million, partially offset by lower severance expenses of approximately $1.7 million and lower regulatory and licensing fees of approximately $0.5 million. Excluding one-time legal expenses, selling, general and administrative expenses increased to $66.6 million for the full year 2025 from $50.2 million for the full year 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Including one-time legal expenses, selling, general and administrative expenses increased to $79.8 million for the full year 2025 from $50.2 million for the full year 2024. The increase primarily represents higher legal fees of approximately $14.3 million, higher commercial spending of approximately $9.6 million in preparation for the launch of Anaphylm, the Anaphylm PDUFA fee of $4.3 million, higher personnel expenses of approximately $1.9 million, higher regulatory expenses related to Anaphylm of approximately $1 million, and higher share-based compensation expenses of approximately $0.9 million, partially offset by decreases in severance expenses of approximately $2.8 million and lower insurance expenses of approximately $0.6 million.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Excluding one-time legal expenses, Aquestive's net loss for the fourth quarter of 2025 was $18.7 million or $0.15 for both basic and diluted loss per share, compared to the net loss for the fourth quarter of 2024 of $17.1 million or $0.19 for both basic and diluted loss per share. Including one-time legal expenses, Aquestive's net loss for the fourth quarter of 2025 was $31.9 million or $0.26 for both basic and diluted loss per share, compared to the net loss for the fourth quarter of 2024 of $17.1 million or $0.19 for both basic and diluted loss per share.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

The increase in net loss was primarily driven by increases in selling, general and administrative expenses and manufacturer and supply expenses, partially offset by decreases in research and development expenses and increases in revenue and interest income and other income. Excluding one-time legal expenses, Aquestive's net loss for the full year 2025 was $70.6 million or $0.66 for both basic and diluted loss per share, compared to the net loss for the full year of 2024 of $44.1 million or $0.51 for both basic and diluted loss per share.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Including one-time legal expenses, Aquestive's net loss for the full year of 2025 was $83.8 million or $0.78 for both basic and diluted loss per share, compared to the net loss for the full year of 2024 of $44.1 million or $0.51 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses and manufacturer and supply expenses, and decreases in revenue, partially offset by decreases in R&D expenses and increases in interest income and other income. Excluding one-time legal expenses, non-GAAP adjusted EBITDA loss was $14.1 million in the fourth quarter of 2025 compared to non-GAAP adjusted EBITDA loss of $11 million in the fourth quarter of 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses and one-time legal expenses, was $10.8 million in the fourth quarter of 2025 compared to non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, of $6.6 million in the fourth quarter of 2024. Excluding one-time legal expenses, Aquestive's non-GAAP adjusted EBITDA loss was $49.7 million for the full year of 2025 compared to non-GAAP adjusted EBITDA loss of $23 million for the full year of 2024. Non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses and one-time legal expenses, was $34.4 million for the full year of 2025 compared to non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, of $4 million for the full year of 2024.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

As of December 31st, 2025, cash and cash equivalents were $121.2 million. As outlined in the press release issued last night after market close, our outlook for 2026 is total revenue of $46 million-$50 million and non-GAAP adjusted EBITDA loss of $30 million-$35 million. We expect to end 2026 with approximately $70 million, excluding any additional proceeds from RTW or out licensing transactions.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Our non-GAAP adjusted EBITDA loss guidance for 2026 includes costs associated with the resubmission of the NDA for Anaphylm, continued pre-commercial infrastructure spending for Anaphylm, clinical trial costs for AQST-108, and regulatory applications for Anaphylm in Canada and the EU. Current guidance does not include costs associated with the sales and marketing of Anaphylm if approved by the FDA. With that, I will now turn the line back to the operator to open the line for questions.

Operator

Thank you. Ladies and gentlemen, as a reminder to ask a question at this time, you will need to press star one one on your touch-tone telephone. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Roanna Ruiz with Leerink Partners. Your line is now open.

Roanna Ruiz
Roanna Ruiz
Senior Research Analyst at Leerink Partners

Hey. Morning, everyone. Couple for me, starting with the Type A meeting with the FDA. I just wanted to confirm I heard it correctly. It sounds like you submitted a request, but it has not been scheduled yet, but that could happen soon. Secondly, could you elaborate a bit on your main goals going into this meeting? Is there any additional information you need to prepare for the FDA for this meeting?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sure. Good morning, Roanna. I'll hand it over to Melina in a second here. Just a couple of basic things. We have submitted. We expect that meeting to happen shortly. I'll let Melina walk you through kind of the, I'll call it the contract that the FDA has to uphold. From a goals perspective, we don't need a lot out of this meeting, and I'll also let Melina elaborate a little bit on that.

Melina Cioffi
Melina Cioffi
SVP of Regulatory Affairs at Aquestive Therapeutics

Okay, thank you, Dan. In terms of the timing, the FDA guidelines state that the agency should meet with the sponsor within 30 days from the date that we submitted our meeting request and our briefing book. If they go according to the timelines, we should be able to meet with them towards the end of this month or very early April. In terms of the goals of the meeting, we shared with them our briefing book that outlined our commitment to conduct the two studies that they requested in the CRL. And we also asked questions to ensure that we walk away essentially from this meeting with clear alignment on how best to execute for the purposes of the research.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Right. and Roanna, I would just remind you and those on the call, it's been 31 days since we received our CRL. In those 31 days, we've not only written the protocols, contracted our CROs, changed our packaging, written a briefing book, resubmitted that briefing book to the FDA, but obviously also brought on a new Chief Medical Officer and redesigned our deal with RTW. We feel really good that we are on track in every way, and the Type A meeting is just one part of that.

Roanna Ruiz
Roanna Ruiz
Senior Research Analyst at Leerink Partners

Yep, that's super helpful. A follow-up on that, I think you mentioned doing a modification to the proposed protocol that the FDA mentioned in the CRL. Could you just explain a bit more about that? Is it relatively straightforward? You know, how should we think about it moving with the FDA interaction with you coming up?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Yeah, that's in my view. We won't get into the exact question. We'll obviously be able to share that in a few weeks here. That's literally the only question we have for the FDA, and we're fine with the answer either way. It's a minor modification. Matthew Davis and his team just wanna make sure they understand how the FDA is thinking about it. Once we have the answer, we'll there's nothing more we need.

Roanna Ruiz
Roanna Ruiz
Senior Research Analyst at Leerink Partners

Okay, great. Thanks so much.

Operator

Thank you. Our next question coming from the line of Kristin Kuska with Cantor Fitzgerald. Your line is now open.

Kristin Kuska
Kristin Kuska
Associate Analyst of Healthcare Equity Research at Cantor Fitzgerald

Good morning, everybody. Thanks for taking my questions. I have a couple as well. First, on the RTW, great to see you extended that option. Noticed that the language was through the end of June next year. You had told us that your expectation is that it would be a six-month review upon submitting. Is the timeline here just to give you a little bit of buffer room on that back end? Then also can you just confirm that it's still $75 million and that those terms haven't changed?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Yeah. The second question I'll turn over to Ernie in a second. In terms of the timing of why June 30th, 2027, that's easy. It's easy to modify by one year. We in no way expect to need anywhere near that amount of time to bring our product to market, it's just an easy way to update the contract. I'll let Ernie talk about any other changes.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Sure. Hi, Kristin. Yes, we confirm that none of the terms of the agreement with RTW have changed. I think the important thing is here with the additional purchase of $5 million, you know, we appreciate their continued support as we move forward through the process this year of resubmission and hopefully an approval and launching the product next year.

Kristin Kuska
Kristin Kuska
Associate Analyst of Healthcare Equity Research at Cantor Fitzgerald

Okay, thank you. I know Sherry and team have been doing a lot of work in terms of mapping territories this past year. Wanted to ask a little bit more on this decision to add 50% more sales reps. Was this just driven by seeing new pockets where you think you would need more boots on the ground, or is there anything specific that led to this decision as well as the specific percent more that you'll be adding?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sure. I'll let Sherry take that.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

Hi, Kristin. How are you? Thanks so much for asking this question. We're very excited about our decision. Why did we do it? We went back, as we've been doing with all of our commercial work that we were preparing for launch, to say how many more reps would we need to cover much deeper, penetrate much deeper into the allergist market and in the same regard ensuring that we're also the reps will be calling on the pediatricians that are the high decile pediatricians. When we took a look at the reach and frequency that we're able to achieve by moving towards the approximate 75 reps, there are a couple of reasons why that made sense.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

One was obviously, with smaller territories, it allows our reps to have greater efficiency as that will allow them not to have to travel, you know, hours to see all the important physicians. One, it's greater efficiency. Two, it closes white space. As I'm sure you can imagine, with 50 reps, we would have had a lot of white space. We would have handled that through inside sales reps. However, again, by moving to the 75 reps, it gives us much greater coverage.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Kristin, I think you can see that our investment in the allergy community is growing in general. So it's not just the reps, but with Matt Greenhawt and the medical affairs team getting bigger as well, our ability to be out there with publications. You saw our presence at AAAAI last weekend. We are demonstrating we are front and center as we go into launch.

Kristin Kuska
Kristin Kuska
Associate Analyst of Healthcare Equity Research at Cantor Fitzgerald

Thanks, everyone.

Operator

Thank you. Our next question coming from the line of David Amsellem with Piper Sandler. Your line is now open.

David Amsellem
David Amsellem
Managing Director and Senior Research Analyst at Piper Sandler

Thanks. Just a couple for me. One is, taking a step back, can you talk about how you settled on the trial design and are you prepared to make any modifications to the design coming out of the meeting with the FDA if necessary? Just wanted to get a window into your thought process in terms of how you design the trial. That's number one. Number two is with the sales force, the bigger sales force, wanted to ask how you're thinking about DTC. Are you going to take a more expansive approach to DTC? That's particularly in the context of your competitor being fairly aggressive here. Wanted to get your thoughts on that. Lastly, on 108, real quick question.

David Amsellem
David Amsellem
Managing Director and Senior Research Analyst at Piper Sandler

I think you made a comment in the press release about indication selection. Just want to be clear, is it going to be alopecia areata or are you thinking about other indications or maybe pivoting to something else? Just wanted to clarify on that. Thank you.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sure. Good morning, David. Let me take the sales force DTC question first and then I will hand it over to Matthew to talk about trial design, especially on the PK side, and how we can be ready for any modifications if necessary. From a DTC perspective, we still believe that DTC is best served once you have a reasonable market share. We also have a competitor, to your point, who's spending a lot of money on DTC, which we see growing the overall market. It's growing the auto injector market. We continue to believe, let the competitors spend money in that area. We focus on our touches directly with reps.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Let me pass it over to Matthew on your question number one, which was, how we settled on our trial design if we have to make modifications.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

Thank you very much for the question. We have the optionality of doing two things at the same time. Upon looking at the FDA's request, we have a trial design that's in line with what the information they want to seek. We also believe based on our 11 other PK trials that we've done, that we have enough information to categorize some of that information. With the updated human factors research that we're going to do, we believe that maybe not all the arms are going to be necessary. If the FDA at the meeting invites this trial design to be exactly what they asked in the CRL, we are also ready to do that. At the end of the FDA meeting, we're going to have the clarity for the trial design.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

We already have protocols that take optionality into account, and we will meet our commitments, that Dan has already stated for the finishing of the trial and the resubmission of Anaphylm.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Let's, I'll actually stick with Matthew here and, for the third one, which is on the indication selection for 108. I will say, alopecia areata remains the indication we're focused on, but Matthew can give his thoughts on as we go through the development process, if there are other opportunities we might see.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

I'm going to elaborate more once we get the results of the current trial that we've done. In a 50,000-foot view, not only did we look at our areata, alopecia areata, we also looked at healthy normal patients. Looking at the product's pharmacokinetics and safety and other factors like proteomics, this will help inform us on future indications. More to come on that, but we're making sure we have optionality to continue on with alopecia areata and also look at other topical indications that 108 would be designed for.

David Amsellem
David Amsellem
Managing Director and Senior Research Analyst at Piper Sandler

Okay, that's helpful. Thank you.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Thank you.

Operator

Thank you. Our next question coming from the line of Reza Vahidi with LifeSci Capital. Your line is now open.

Reza Vahidi
Reza Vahidi
Managing Director and Head of Equity Capital Markets at LifeSci Capital

Hey, thanks for the questions. I was just wondering, in terms of the added reps here, the 50% more reps, can you remind us when you the timing of the hiring here, is this kind of a post-approval or pre? Or just remind us what you're thinking?

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

Yeah. Thanks for the question. Yes, we will continue to follow the same path that we were prepared for a launch this year. We will be interviewing and going through the process so that once with candidates, and so that once we do have approval, then we would flip them immediately to full-time employees. Think about it the same way contingent offers go out, and we're ready to go upon launch.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Frank, I'll just add to Sherry's comments. Just like before, that doesn't delay our launch at all. There's a natural period of a few weeks after approval, as you know, where the supply chain has to kick in. Sherry and her team have done a great job of being ready to strike during that period and make sure we have all of our reps ready to go by the end of that supply chain work.

Reza Vahidi
Reza Vahidi
Managing Director and Head of Equity Capital Markets at LifeSci Capital

Okay, great. If I could follow up, just, any updates on this citizen petition? Where does that stand? Maybe if you can also touch on, you know, you were just at AAAAI, I assume it was a busy weekend. I'm just wondering any takeaways from your perspective on how AAAAI went for Aquestive.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sure. Yes. The citizen petition that was filed by a competitor was denied by the FDA last week, which to us obviously was what we expected, but it's another validating point for our data package. In addition to the strong outcome and the de-risking event you saw out of the CRL, where it's focused on human factors, we also now see, just a matter of a couple of weeks later, a moment where the FDA is once again validating the strength of our package. We feel really good about where we are with the FDA, especially from a clinical perspective. As you heard from the team, we're on track, and we're ready to go.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

In terms of AAAAI, which was last weekend for those who are not familiar, and that is the biggest allergy conference in terms of attendance in a year. My biggest learning and I'll toss it over to Sherry in a second to... you know what? Let's actually let Matthew Greenhawt join in as well. In a second, I'll pass it over to Matt instead of Sherry. From my perspective, what I heard consistently were two things. One, the allergist community believes in our ability to get to approval given what was in the CRL. Two, they can't wait for our product. Very excited on both those fronts. Matt, maybe you could give a couple of your thoughts.

Matt Greenhawt
Matt Greenhawt
CMO at Aquestive Therapeutics

Hi. Good morning. As usual, the AAAAI is a very busy and intense meeting. There's a lot of allergists, not only from the U.S., but globally. It's a good draw. What I observed was a lot of excitement and curiosity about a new option for treating patients. As a practicing allergist, something like this, you know, adds a lot of potential to how we can help serve patients. You know, to be able to interact with allergists and other people coming up to the booth and seeing us, you know, walking through the halls, you know, the feedback I think is very consistent with what Dan just said, that there's excitement, there's curiosity. That's, it's exciting. A year from now, I think it'll be even more exciting.

Reza Vahidi
Reza Vahidi
Managing Director and Head of Equity Capital Markets at LifeSci Capital

Excellent. Thank you.

Operator

Thank you. Our next question, queue coming from the line of Andreas Argyrides with Oppenheimer Your line is now open.

Andreas Argyrides
Andreas Argyrides
Executive Director and Senior Analyst at Oppenheimer

Good morning, and thanks for taking our questions, a couple from us here. How are you viewing the requirements of the PK study as diverging from previous PK studies, including chewing and with or without water intake? How are you thinking about addressing the FDA's concerns around tolerability despite what you point to are minimal cases? You recently presented additional data at AAAAI around diastolic blood pressure, citing no dip there. Can you elaborate on the importance of these data with regards to the FDA? Thanks so much.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sure. Good morning, Andreas. I'll, I'll spread the wealth with these three questions. I'll have Matthew in a second talk about the requirements from PK prior, including chewing. I'll ask Matt to talk about diastolic blood pressure, and then I'll finish up on tolerability. Matthew, why don't you start.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

This will be our 12th pharmacokinetic trial on this product. Like the other studies, we're going to use the same vendor that we had excellent experience with. We're gonna use the same laboratory that we had excellent experience with. We're going to, as the FDA requested, have all patients have healthcare administered Advil. Like the FDA requested, we're going to have all patients also have an injection of IM manual epinephrine. We've done this for our other pharmacokinetic trials. As the FDA requested, we're also going to have patients, some patients receive self-administered epinephrine, Advil, that is going to follow the new updated instructions for use that are gonna be tested and validated in human factors trial. In addition, the FDA has requested top of tongue, that was by far our largest observation in the last human factors trial.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

Of course, we'll be doing this. We'll have a discussion with the FDA on your other question on chewing, and we believe that this information can already be informed in the labeling

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

By the fact that patients have already been tested and swallowed Anaphylm with eight ounces of water. Those patients did reach a therapeutic level of above 100 milligrams per milliliter. We'll have that discussion with the FDA. If the FDA believes that we have enough information to inform the label as we believe, then we'll proceed with the design that I just stated. If the FDA would like us to continue with the design that they stated, we also will do what they request. Either way, we're ready for this trial.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Matt, if you could talk a little bit about how you think about diastolic blood pressure and whether it be our product or other products in the space.

Matt Greenhawt
Matt Greenhawt
CMO at Aquestive Therapeutics

Diastolic blood pressure is one of these interesting things clinically. You need your diastolic blood pressure to help maintain, you know, feeding blood to your coronary arteries during shock. One of the things that's been observed now for a number of years with additional data with auto-injectors is that the injectable route, you see a slight dip for a couple of minutes, where the diastolic blood pressure goes down and then comes up. You know, Anaphylm operates a little bit differently than that, in that there is no initial dip. What that may lead to is potential improvements in something called mean arterial pressure, which in like shock, it's a distributive shock. You know, you think about your plumbing system, there's runoff downstream and there's low pressure. You want to increase your mean arterial pressure. It'll help perfuse your coronaries.

Matt Greenhawt
Matt Greenhawt
CMO at Aquestive Therapeutics

It'll keep the system running at a higher pressure. You know, when you're resuscitating a patient, that's really what you're aiming for. You seem to be fairly ideal properties that one would want on paper for, how you would resuscitate somebody. You know, it's exciting to be able to report those data. These are very interesting studies, and you learn a lot about sort of the epinephrine space, which with each of these studies that gets reported.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Andreas, let me take the tolerability piece. One of the things we didn't overly focus on in our original submission is what tolerability looks like across all of the products. It's interesting when you step back and you look at the experience with the medical devices, there are multiple tolerability issues that occur. You know, we don't need to go into the specifics for each product on this call. In our resubmission, we'll definitely be making sure we characterize our product versus the alternatives that are available. Then, as we stated in the supplemental material that you can see, if you go back to our study, there's very few cases. There's four individuals who had any ability to point to tolerability.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

One of the individuals who said, unprompted, "Well, if my life was at risk, I would leave the product in as long as I needed to." I think on this issue, I would put it at much ado about nothing, and we'll make sure that we better characterize the current state in this space in our resubmission.

Andreas Argyrides
Andreas Argyrides
Executive Director and Senior Analyst at Oppenheimer

Okay, great. Thanks, guys.

Operator

Thank you. Our next question coming from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is now open.

Raghuram Selvaraju
Raghuram Selvaraju
Managing Director and Senior Healthcare Analyst at H.C. Wainwright

Hello. Thanks so much for taking our questions. Firstly, I was wondering if you could comment on any fundamental changes in your anticipated promotional campaign for support of Anaphylm as and when the product gets approved in the context of the revised sales force sizing and if you see any recent moves by the folks promoting Neffy that would guide promotional decisions that you're making in advance of the Anaphylm launch?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sherry, you want to take that?

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

Sure. Thanks so much for the question. As Dan mentioned earlier, our commercial infrastructure has mainly stayed intact. Because of that, it is giving us time to go back and really refine our launch plan, aligned with having 75 reps, being well-positioned if Anaphylm is approved by the FDA. I do think, though, that it continues, as you know, to be there is a significant unmet need in what continues to be a growing market. As Dan mentioned, you know, with the competitive DTC, they continue to grow the market. That's a really positive thing. There's still a need for an oral, easy to carry, easy to use, non-needle, non-device. We heard it over and over again this weekend at AAAAI.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

What I would say is there's not fundamental changes in the work we're doing or the messaging, but we are taking the time, Ram, to really refine our positioning and refine all of the tactics that our reps will take to launch. As it relates to the competitors, look, we are always looking at the tactics, the promotional efforts, and it is informing us, looking at their share of market and evaluating what is working and what is maybe not working as well. That is all going to inform our launch plan.

Raghuram Selvaraju
Raghuram Selvaraju
Managing Director and Senior Healthcare Analyst at H.C. Wainwright

Very helpful. Thank you. Secondly, I was wondering if you could just clarify how you're thinking about the timeline for future clinical development of AQST-108 relative to the timeline for the Anaphylm NDA resubmission and potential approval and launch timing for Anaphylm. Are you thinking about these two things completely independently? If they are connected in any way, you know, can you give us a sense of how? Maybe just provide some granularity regarding the timing with which you expect to conduct the next stage of clinical development with AQST-108. Thank you.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Yeah. No, no, thanks, Ram. Look, given the size and the focus of our organization, the only answer to this one is they absolutely are linked, and Anaphylm's always gonna win when there's a competition between Anaphylm and AQST-108. I'm lucky to sit in this room with some great executives, as you've heard this morning, they're the same executives who are over AQST-108. We will prioritize Anaphylm both from a resource perspective and a monetary perspective in the short term. Having said that, we do have the ability to keep AQST-108 moving, to keep learning, as Matthew talked about, around what we've got on our hands and how many different ways we can use it and to keep progressing it clinically.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Once we get past the Anaphylm resubmission, and we really hand over Anaphylm to the commercial side, I think that's when you'll see the workload on AQST-108 pick up with our development team.

Raghuram Selvaraju
Raghuram Selvaraju
Managing Director and Senior Healthcare Analyst at H.C. Wainwright

Okay, great. Just two very quick ones. Can you indicate perhaps, you know, through the commercial evidence with regard to at least one or more of the diazepam-based formulations that are currently available on the market, if this provides any kinda market intel or foreshadowing, as it were, of what the future peak sales potential could be for Libervant in the United States? Also, if you could just clarify for us whether the specific amount of the settlement with Neurelis was actually disclosed. Thank you.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Yeah. I'll start with the second one. Unfortunately, it tends to happen with these litigation settlements. It's confidential, so we can't disclose the settlement terms. Obviously, you can see our financial disclosures and make your own assessment. What I would say is we put into our press release is what we were happy about and what led us to getting to the settlement is from a 2026 perspective, we believe it is cash neutral. Whether we had done the settlement or not, same place on cash. In terms of Libervant and looking at that opportunity and what peak sales could be for Libervant, this one's bittersweet, Ram.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

I would love to launch Libervant, and we have put our heart and soul into what we believe is a great product that will help patients in this space. We can't launch Libervant and Anaphylm within a month of each other. It's just not humanly possible for the companies even much larger than us. We've made the decision that Anaphylm is the priority. We do have some great potential partnerships, licensing opportunities that our team is looking at. I do think that if you look at how Valtoco and Nayzilam have penetrated in that market, there's still a great opportunity, especially where portability, convenience, speed of use are important for this product to become an important component in that space.

Raghuram Selvaraju
Raghuram Selvaraju
Managing Director and Senior Healthcare Analyst at H.C. Wainwright

Thank you.

Operator

Thank you. Our next question coming from the line of Thomas Flaten with Lake Street Capital Markets. Your line is now open.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

Good morning, everybody. Thanks for taking the questions. Are there any current analogs that give you some faith in a potential accelerated approval? I know FDA in its current incarnation can be a little bit confusing.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Sure. That's an easy one. Our competitor got a CRL and resubmitted with a six-month clock and got their approval in four months. We'll do it nicely, but we will definitely be reminding this review division that they did that and that our expectation is we're handing in a very thin package to meet their requests. It shouldn't take 6 months to review. Now, whether they act fast or not, Thomas, to your underlying point, is completely up to them.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

Got it. Is it safe for us to assume that any submissions outside the U.S. will be after the full package has been resubmitted to FDA, just timing-wise?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Yes. Yes. We're guiding that, Europe and Canada will be in 2026, but they will come after U.S. Canada, literally, we could put in whenever we get it done, but it's just gotta come after the U.S. Some of this is just making sure we prioritize the U.S. over everything else.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

Got it. I guess regardless of approval time, could you clarify a little bit, 'cause I know there's a few things going on, including hiring of the reps, some of the product-related work you have to do. From approval to full commercial launch, can you give us a sense of what that timing will look like?

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Yeah. Approval to... If by full commercial launch, you mean reps in the field and product in distribution, I think it's the same timeline we guided to this last go-around, which it was, if you think about it, around an eight-week window. The what it precisely is under eight weeks is all dependent on how much we lean forward ahead of approval. Call it zero to eight weeks.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

Got it. Appreciate that. Thank you.

Operator

Thank you. I'm showing no further questions in the queue at this time. I will now turn the call back over to Mr. Daniel Barber for any closing remarks.

Daniel Barber
Daniel Barber
President and CEO at Aquestive Therapeutics

Thank you, Livia, and thank you everyone for joining us today. As you heard, we are on track in every way right now. The epinephrine market continues to grow, and we're excited for patients to have access to Anaphylm as soon as it is approved by the FDA. We look forward to keeping you updated on our progress in the weeks and months to come. With that, Livia, let's end the call.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Executives
Analysts
    • Andreas Argyrides
      Executive Director and Senior Analyst at Oppenheimer
    • David Amsellem
      Managing Director and Senior Research Analyst at Piper Sandler
    • Faith Pomeroy-Ward
      Marketing, PR, and Corporate Communications at Allergy & Asthma Network
    • Kristin Kuska
      Associate Analyst of Healthcare Equity Research at Cantor Fitzgerald
    • Raghuram Selvaraju
      Managing Director and Senior Healthcare Analyst at H.C. Wainwright
    • Reza Vahidi
      Managing Director and Head of Equity Capital Markets at LifeSci Capital
    • Roanna Ruiz
      Senior Research Analyst at Leerink Partners
    • Thomas Flaten
      Senior Research Analyst at Lake Street Capital Markets
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