Aquestive Therapeutics, Inc.

Good day and thank you for standing by. Welcome to Equestrian Therapeutic Support Quarter 2025 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 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.

Thank you, operator. Good morning and welcome to today's call. On today's call, I'm joined by Dan 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 Greenhut, Chief Medical Officer, Melina Chaffee, Senior Vice President, Regulatory Affairs, Sherry Korchinski, 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 closed yesterday. In addition, A recording of today's call and related supplemental materials will be made available on Equestive's website within the investor section shortly following the conclusion of this call. To remind you, the Equestive 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 investor's section of Equestiv's website. During the call, the company will be making forward-looking statements. 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 4, 2026. As 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. All forward-looking statements attributable to a questive 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. Now, I would like to turn the call over to Dan.

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 Equestiv'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 Anafilm 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. We have already selected our clinical research organizations for both the human factor 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 Equestis. With the recent addition of Dr. Matt Greenhawk, a world-renowned allergist and this year's recipient of the prestigious Distinguished Clinician Award, by the American Academy of Allergy, Asthma, and Immunology, or Quad AI, 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. GREENHAUT JOINING US, WE ARE MORE THAN DOUBLING THE SIZE OF OUR MEDICAL AFFAIRS ORGANIZATION. 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 US. We remain on track to file in Europe and Canada before the end of the year. We also will be meeting with the UK Health Authority, known as MHRA, in the coming weeks. We are confident that antifilm can benefit all humans, and we want to expand access to our product outside of the US as rapidly as possible. Now let's turn to the commercial side. Launching a prescription drug in the US 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. As you may recall from my comments a month ago, Sherry Korchinski, 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 teams. 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 as well for a potential launch. In terms of the underlying allergy market, we continue to see overall prescription growth. EpiPen and generic autoinjectors grew by approximately 5% in the fourth quarter of 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. Over 90% of prescriptions remain with autoinjectors. And, 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 autoinjectors and nasal sprays. Given the potential near-term launch of Anafilm 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 and I am pleased to remove this distraction from the business. 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 Annafilm launch, our initial focus with Libervin 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 Libervin 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 anafilm and expect to use a licensing approach for that market. 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 Adreniverse, 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 Equestis. We have a clear path to market for anafilm. We have a clear path to the necessary capital to launch anafilm 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 Libervin and XUS for Anifilm, and we continue to progress our long-term pipeline. With that, I will turn the call over to Ernie.

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 fourth quarter of 2025 and full-year 2025 results in the Q&A. During 2025, we made great progress in positioning Equestiv for future success, including submitting the NDA for anafilm, 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 Antifilm, and ended 2025 with $121 million with cash runway to support costs associated in preparing for the Antifilm NDA resubmission, including the new human factors validation study and supportive PK study, pre-commercial infrastructure costs, to increase awareness of antifilm 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 one 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 Antifilm, if approved by the FDA. RTW has also agreed to an additional strategic investment of $5 million in requested, showing continued confidence in the company. Let's turn to the recap of our quarterly and full-year financial results. Total revenues increased to $13 million in the fourth quarter of 2025 from $11.9 million in the fourth quarter of 2024. This 10% increase in revenue was primarily driven by increases in manufacturer and supply revenue. Manufacturer 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. 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 UNDIF 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 Antifilm 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. The decrease in R&D expenses was primarily due to lower clinical trial costs associated with the continued advancement of the antifilm 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 of 2025 from $16 million in the fourth quarter of 2024. including the one-time legal expenses, selling, general, and administrative expenses increased to $32.8 million in the fourth quarter of 2025, from $16 million in the fourth quarter of 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 Anifilm, 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. 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 Anifilm, the Anifilm PDUFA fee of $4.3 million, higher personnel expenses of approximately $1.9 million, higher regulatory expenses related to Anifilm 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. Excluding one-time legal expenses, Equestria's net loss for the fourth quarter of 2025 was $18.7 million, or 15 cents, for both basic and diluted loss per share, compared to the net loss for the fourth quarter of 2024 of $17.1 million, or 19 cents for both basic and diluted loss per share. Including one-time legal expenses, of Questive's net loss for the fourth quarter of 2025 was $31.9 million, or 26 cents for both basic and diluted loss per share, compared to the net loss for the fourth quarter 2024 of $17.1 million, or 19 cents, 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, partially offset by decreases in research and development expenses and increases in revenue and interest income and other income. Excluding one-time legal expenses, Equestria's net loss for the full year 2025 was $70.6 million, or 66 cents for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million, or 51 cents for both basic and diluted loss per share. Including one-time legal expenses, AQUESTA's net loss for the full year 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 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 2024. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses was $10.8 million in the fourth quarter 2025 compared to non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $6.6 million in the fourth quarter 2024. Excluding one-time legal expenses, Equestria's non-GAAP-adjusted EBITDA loss was $49.7 million for the full year 2025, compared to non-GAAP-adjusted EBITDA loss of $23 million for the full year 2024. Non-GAAP-adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses was $34.4 million for the full year 2025 compared to non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $4 million for the full year 2024. As of December 31st, 2025, cash and cash equivalents were $121.2 million. As outlined in the press release issued last night after market closed, our outlook for 2026 is total revenue of $46 million to $50 million, and non-GAAP adjusted EBITDA loss of $30 million to $35 million. We expect to end 2026 with approximately $70 million, excluding any additional proceeds from RTW or out-licensing transactions. Our non-GAAP adjusted EBITDA loss guidance for 2026 includes costs associated with the resubmission of the NDA for antifilm, continued pre-commercial infrastructure spending for antifilm, clinical trial costs for AQST-108, and regulatory applications for antifilm in Canada and the EU. Current guidance does not include costs associated with the sales and marketing of antifilm if approved by the FDA. With that, I will now turn the line back to the operator to open the line for questions.

Thank you. Ladies and gentlemen, as a reminder, to ask a question at this time, you will need to press star 1-1 on your touchtone telephone. To withdraw your question, simply press star 1-1 again. Please stand by while we compile the Q&A roster. Now, first question coming from the line of Rowana Ruiz with Learing Partners. Your line is now open.

Hey, morning, everyone. So a 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. And secondly, could you elaborate a bit on your main goals going into this meeting, and is there any additional information you need to prepare for the FDA for this meeting?

Sure. Good morning, Rowana. 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 contract that 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.

Thank you, Dan. So 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. So if they go according to the guidelines, we should be able to meet with them towards the end of this month. for very early April. In terms of the goals of the meeting, we shared with them our briefings that outlined our commitment to conduct the two studies that they requested in the CRO. 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.

And Rowana, I would just remind you and those on the call, it's been 31 days since we received our CRO. And 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. So we feel really good that we are on track in every way. And the type A meeting is just one part of that.

Yep, that's super helpful. And 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? And how should we think about it with the FDA interaction with you coming up?

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

Okay, great. Thanks so much.

Thank you. Our next question coming from the line of Kristen Kliska with Kent Office. Gerald, your line is now open.

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. Notice 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? And then also, can you just confirm that it's still $75 million and that those terms haven't changed?

Yeah, the second question, I'll turn it over to Ernie in a second. But in terms of the timing of why June 30, 2027, that's easy. because 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, but it's just an easy way to update the contract. But I'll let Ernie talk about any other changes.

Hi, Chris, and yes, we can 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, 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.

Okay, thank you. And then I know Sherry and team have been doing a lot of work in terms of mapping territories this past year. So I 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?

I'll let Sherry take that.

Hi Kristen, 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 approximately 75 reps, there are a couple reasons why that made sense. One was, obviously, with smaller territories, it allows our reps to have greater efficiency as that will allow them not to have to travel hours to see all the important positions. So one, it's greater efficiency. Two, it closes white space. So 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.

And Kristen, 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 Greenhut and the medical affairs team getting bigger as well, our ability to be out there with publications. You saw our presence at Quad AI last weekend. We are front and center as we go into launch.

Thanks, everyone.

Thank you. Our next question, coming from the lineup, David Anselm with Piper Sandler. Yolanda, it's now open.

Thanks. So just a couple for me. One is maybe 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. So that's number one. Number two is with the Salesforce, the bigger Salesforce, wanted to ask how you're thinking about DTC. Are you going to take a more expansive approach to DTC? And that's particularly in the context of your competitor being fairly aggressive here. So I wanted to get your thoughts on that. And then lastly on 108, real quick question. I think you made a comment in the press release about indication selection. So I 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? I just wanted to clarify on that. Thank you.

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

Thank you very much for the question. We have the optionality of doing two things at the same time. So upon looking at the FDA's request, we have a trial design that's in line with what the information they want to seek. And 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. And 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. But if the FDA at the meeting would like these trial designs to be exactly what they asked of the CRL, we're also ready to do that. So at the end of the FDA meeting, we're going to have the clarity for the trial design. We already have protocols to 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 ATAFA.

And I'll actually stick with Matthew here for the third one, which is 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.

Now, I'm going to elaborate more once we get the results of the current trial that we've done. But in a 50,000-foot view, not only did we look at alopecia areata, we also looked at healthy normal patients. And looking at the products, pharmacokinetics, and safety, and other factors like proteomics. This will help inform us on future indications. So 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.

Okay, that's helpful. Thank you.

Thank you. Our next question, coming from the lineup, Rensselaer Fisica with Lifestyle Capital, Yolanda Snellman.

Hi, thanks for the questions. And 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?

Yeah, thanks for the question. Yes, we will continue to follow the same path that we were prepared for 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. So think about it the same way. Contingent offers go out and we're ready to go upon launch.

And Frank, I'll just add to Sherry's comments. Just like before, that doesn't delay our launch at all. So there's a natural period of a few weeks after approval, as you know, where the supply chain has to kick in. And 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.

Okay, great. And then if I can follow up, just any updates on this citizen's petition? Where does that stand? And then maybe if you can also touch on, you know, you were just at Quad AI. I assume it was a busy weekend. I'm just wondering any takeaways from your perspective on how Quad AI went for Equestria.

Sure. Yes. So 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. So 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. So 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. terms of quad AI which was last weekend for those who are not familiar and that is the biggest allergy conference in terms of attendance in a year of my biggest learning and I'll toss it over to Sherry in a second to you know what let's actually let Matt Greenhut join in as well so in a second I'll pass it over to Matt instead of Sherry but 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. And two, they can't wait for our product. So very excited on both those fronts. So Matt, maybe you could give a couple of your thoughts.

Hi, good morning. As usual, the Quad AI is a very busy and intense meeting. There's a lot of allergists, not only from the U.S., but globally, so 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 adds a lot of potential to how we can help serve patients. So to be able to interact with allergists and other people coming up to the booth and seeing us walking through the halls, the feedback is very consistent with So, it's exciting. In a year from now, I think it'll be even more exciting.

Excellent. Thank you.

Thank you. Our next question, Q, coming from the lineup, Andreas Agnes with Oppenheimer Yolanis-Malfin.

Good morning, and thanks for taking our questions. A couple from us here. So, how are you viewing the requirements of the PK study 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? And you recently presented additional data at Quad AI 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.

Sure. Good morning, Andreas. 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. But Matthew, why don't you start?

So this will be our 12th pharmacokinetic trial on this product. So like the other we're going to use the same vendor that we had excellent experience with. We're going to use the same laboratory that we had excellent experience with. We're going to, as the FDA requested, have all patients have healthcare administered anafilm. Like the FDA requested, we're going to have all patients also have an injection of IM manual epinephrine. And we have done this for our other pharmacokinetic trials. As the FDA requested, we're also going to have patients, some patients receive self-administered epinephrine, Adafilm, that is going to follow the new updated instructions for use that are going to be tested and validated in human factors trial. In addition, the FDA has requested top-of-tongue, and that was by far our largest observation in the last human factors trial. And 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 by the fact that patients have already been tested and swallowed anafilm with eight ounces of water. And we do, and those patients did reach a therapeutic level of above 100 grams per milliliter. So 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.

And Matt, if you could talk a little bit about how you think about

Diastolic blood pressure is one of these interesting things clinically. You need your diastolic blood pressure to help maintain feeding blood to your coronary arteries during shock. So one of the things that's been observed now for a number of years with additional data with autoinjectors 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, anafilm operates a little bit differently than that in that there is no initial shift. So what that may lead to is potential improvements in something called mean arterial pressure, which in shock, it's a distributive shock. 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 coronary. 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. So these seem to be fairly ideal properties that one would want on paper for how you would resuscitate somebody. And, 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 with each of these studies that gets reported.

And, Andres, let me take the tolerability piece. So one of the things we didn't overly focus on in our original submission is what tolerability looks like across all of the products. So it's interesting when you step back and you look at the experience with the medical devices, there are multiple tolerability issues that occur. And we don't need to go into the specifics for each product on this call. So in our resubmission, we'll definitely be making sure we characterize our product versus the alternatives that are available. And 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. One of the individuals who said, unprompted, most of my life was at risk. I would leave the product in as long as I needed to. 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.

Okay, great. Thanks, guys.

Thank you. Our next question, coming from the lineup, from Sakaraju with HC Renright, Yolanda Snellman.

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 anafilm as and when the product gets approved in the context of the revised Salesforce sizing and if you see any recent moves by the folks promoting NEFI that would guide promotional decisions that you're making in advance of the Anifilm launch? Sherry, do you want to take that?

Sure. Thanks so much for the question. As Dan mentioned earlier, our commercial infrastructure has mainly stayed intact. And so because of that, it is giving us time to go back and really refine our launch plan, aligned with having 75 reps, and being well-positioned if anafilm 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. And as Dan mentioned, you know, with the competitive DTC, they continue to grow the market. And so that's a really positive thing. But there's still a need for an oral treatment easy to carry, easy to use, non-needle, non-device. We heard it over and over again this weekend at Quad AI. So what I would say is that 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. And so that is all going to inform our launch plans.

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 Anafilm NDA resubmission and potential approval and launch timing for Anafilm. 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? and 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.

Yeah. No, thanks, Ram. And look, given the size and the focus of our organization, the only answer to this one is they absolutely are linked, and the NFL is always going to win when there's a competition between NFL and 108. I'm lucky to sit in this room with some great executives, as you've heard this morning, But they're the same executives who were over 108. So we will prioritize Anafilm, both from a resource perspective and a monetary perspective in the short term. Having said that, we do have the ability to keep 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 once we get past the anti-film resubmission and we really hand over anti-film to the commercial side, I think that's when you'll see the workload on one-way pickup with our development team.

Okay, great. And then 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 kind of market intel or foreshadowing, as it were, of what the future peak sales potential could be for Libervant in the United States. And then also, if you could just clarify for us whether the specific amount of the settlement with Norelis was actually disclosed. Thank you.

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 as 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. So whether we had done the settlement or not, same plays on cash. In terms of Libervin and looking at that opportunity and what peak sales could be for Libervin, this one's bittersweet, Ram. I would love to launch Libervin. And we have put our heart and soul into what we believe is a great product that will help patients in this space. But we can't launch LiberVent and Anifilm within a month of each other. It's just not humanly possible for companies even much larger than us. So we've made the decision that Anifilm is the priority. We do have some great potential partnerships, licensing opportunities that our team is looking at. And I do think that if you look at how Veltoco and Nasalam 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.

Thank you.

Thank you. Our next question coming from Delaina. Thomas Fan with Lake Street Capital Markets. Your line is now open.

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.

Sure. That's an easy one. Our competitor. 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, and it shouldn't take six months to review. Now, whether they act fast or not, Thomas, to your underlying point, is completely up to them.

Got it. And then 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?

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 got to come after the U.S. Some of this is just making sure we prioritize the U.S. over everything else.

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

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 was, if you think about it, around an eight-week window. So what it precisely is under eight weeks is all dependent on how much we lean forward ahead of approval. So call it zero to eight weeks.

Got it. I appreciate that. Thank you.

Thank you. And I'm sure enough for the questions in the queue at this time. I will now turn the call back over to Mr. Dan Barber for any closing remarks.

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 anafilm 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. And with that, Livia, let's end the call.

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