Good day, and thank you for standing by. Welcome to the Fourth Quarter 2024 Aquestive Therapeutics Earnings 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. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Brian Korb. Please go ahead.

Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the fourth quarter year ended 2024, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Kraus, Chief Medical Officer; Dr. Stephen Wargacki, Chief Science Officer and Sherry Korczynski, Senior Vice President, Sales and Marketing. 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 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 2024 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 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 yesterday's earnings release as well as the risks and uncertainties affecting the company as described in the Risk Factors section and other sections included in the company's annual report on Form 10-K filed with the Securities and Exchange Commission on March 05th 2025. 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 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. Now, I would like to turn the call over to Dan.

Thanks, Brian. I am thrilled to announce today that we have begun the filing process with the FDA for approval of our Anaphylm epinephrine sublingual film application. We will complete this application process over the next several weeks and expect the next major milestone for this program, the acceptance of the NDA sometime in June. This puts us on track to launch Anaphylm if approved by the FDA right on schedule in the first quarter of 2026. Today represents the achievement of a major milestone for our company, colleagues, and stakeholders. This achievement was years in the making by scores of dedicated people who have focused their energy on making an impact on patients' lives. I am incredibly proud of and humbled by the achievements of these individuals. For almost three years, you've heard me talk about what we believe patients need in order to be better prepared for a severe allergic reaction including anaphylaxis. We believe an epinephrine product that is carried more often will save lives. We believe epinephrine that is orally administered may be more likely to be used and used quickly and will save lives. We believe that speed matters when it comes to epinephrine absorption, and fast and significant absorption will save lives. Anaphylm was built to meet these needs. And because of this, we believe patients will ultimately choose Anaphylm as their preferred product. Our plan is that less than a year from now, Anaphylm will be approved and available for patient use. This is truly an exciting time for the company. I am also pleased to announce today that our pediatric study for Anaphylm has progressed as expected. Our NDA will include the necessary pediatric data to support the product label that if approved by the FDA would mirror the weight and age parameters of the existing 0.3 mg EpiPen auto injector. Our pediatric data is in line with expectations and we are wrapping up the final pediatric study activities over the coming days. We believe that this will conclude all the information that will be necessary for filing our NDA for Anaphylm. In addition, we have begun preparing for a potential advisory committee meeting for Anaphylm. As you may remember, our FDA pre-NDA meeting notes from November indicate that the FDA may decide to hold an advisory committee meeting. If this were to happen, we would expect it to occur in the second half of 2025. We have hired an experienced regulatory communications firm to aid us in our preparations and we expect to be ready well in advance of the potential meeting. Now let's turn to our sales and marketing preparations for Anaphylm. We recently conducted an awareness trial and usage or ATU study regarding anaphylaxis and Anaphylm. While this work is always a critical component of preparing for launch, we felt it was especially important since a non-needle nasal spray became available to the public over five months ago. In the study, on an aided basis, 92% of the 125 physicians that were interviewed were aware of the FDA approved nasal spray product. Roughly 65% of these physicians had already written a prescription for the nasal spray. Yet when asked to allocate the potential future prescribing habits between auto-injectors, nasal sprays and sublingual film, film received a higher percentage than both the auto-injectors and nasal spray. While I generally view survey data as just directional, I believe it is powerful that physicians who are aware of and have prescribed the existing nasal spray would still list sublingual film as their preferred, most prescribed product under the theoretical premise that film was FDA-approved and available to patients. This is before we have done the significant awareness work in marketing efforts that occurred after approval. Now let's turn to commercialization. We believe there are multiple pathways to commercializing Anaphylm if approved by the FDA. We continue to prepare for launching Anaphylm on our own and most recently hired in house market access expertise to further drive our ongoing discussions with payers. This is in addition to the medical affairs awareness work we have been conducting, including increasing our medical publications, posters and presence at regional and national medical conferences. This work will intensify in the coming quarters as will our commercial preparation. As a reminder, our plan remains to obtain FDA approval prior to hiring a sales force. Another pathway for us to commercialize Anaphylm if approved by the FDA would be to augment our commercial capabilities with a larger, more established sales and marketing organization. This is something that we are actively contemplating, but will only do if the conditions are right for our company. These conditions, at a minimum, include working with a company that has the size and scale to truly expand our engagement efforts and a true commitment to patients in this therapeutic area. Only time will tell what the right path is for Anaphylm. Once we have completed our Anaphylm submission to the FDA, we will also begin focusing on international markets and partnerships. Our initial focus will be to submit applications in the EU, UK and Canada. We are exploring partnerships for ex-U.S. Commercialization of Anaphylm and expect these ex-U.S. Partnerships would contribute significantly to the company. We are also actively planning for our future. In the next quarter, we will open our investigational new drug application or IND for AQST-108, our topical gel formulation of epinephrine. As previously discussed, we believe that AQST-108 could be extremely meaningful to the millions of patients managing alopecia areata or AA as well as other dermatological conditions, we expect to start our Phase 2a trial for AQST-108 in the next quarter and have some level of clinical data available to share with you before the end of this year. This timing is dependent on patient recruitment as well as our final protocol design. As a reminder, an estimated 6.7 million people in the US are affected by AA. Of those affected, 43% are considered severe. The existing therapies for AA are Janus Kinase or JAK inhibitors. These systemic treatments with known side effects come with a black box warning and are expensive for patients. Even with these limitations, the current estimated market opportunity for JAK inhibitors is over $1 billion. As Anaphylm comes to market, if approved by the FDA, we expect AQST-108 to become our lead pipeline opportunity. Now let's turn to Libervant. We were obviously disappointed by the recent federal court ruling that held the FDA's rationale for granting Libervant approval and orphan drug market exclusivity for underserved patients aged between two and five years was not acceptable and we have appealed this ruling. Let's keep in mind that Libervant currently treats young vulnerable children who have in their case recently been diagnosed with epilepsy, are on maintenance medication and are still at risk of seizure clusters. We remain committed to doing everything we can to keep Libervant on the market for these young patients. We will continue to engage the FDA and the court system to protect these patients. We will keep you informed as we learn more. However, it is important to remember that in less than two years, we expect to be able to provide Libervant to all age groups regardless of any outcome in the courts. In conclusion, this is a remarkable time for Aquestive. We have more levers of growth than ever before in the history of the company. We expect to realize the following milestones in the coming months: FDA acceptance of our Anaphylm NDA submission, opening of our IND for AQST-108 and the start of our Phase 2A clinical trial, engagement with international regulatory bodies for expanding Anaphylm filings to ex-U.S. Territories, continuing to build towards the commercial launch of Anaphylm if approved by the FDA and continuing to fight for patient access to Libervant. 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 2024 and full-year 2024 results in the Q&A. During 2024, we made great progress in positioning Aquestive for success. We strengthened our balance sheet by raising over $78 million in capital from high-quality institutional healthcare investors that allowed continued investment in our strategic priorities, including advancing the development of Anaphylm, our lead asset, by completing all planned adult clinical trials and receiving positive feedback in the pre-NDA meeting with the FDA. Having a successful pre-IND meeting for our product candidate AQST-108, a topical gel formulation of epinephrine. Now, let's turn to the recap of our quarterly and full-year financial results. Total revenue decreased to $11.9 million in the fourth quarter 2024 from $13.2 million in the fourth quarter 2023. This 10% decrease in revenue was primarily driven by decreases in license and royalty revenue due to $1 million of milestone royalty revenue for Azstarys from Zevra Therapeutics recognized in the prior year. Manufacture and supply revenue decreased to $10.7 million in the fourth quarter 2024 from $11 million in the fourth quarter 2023, primarily due to a decrease in Suboxone revenues, partially offset by an increase in revenue for Omni from Hypera. License and royalty revenue decreased to $0.8 million in the fourth quarter 2024 from $1.9 million in the fourth quarter 2023, primarily due to the previously mentioned royalty revenue for Azstarys from Zevra Therapeutics recognized in the prior year. Co-development and research fees in the fourth quarter 2024 remain relatively unchanged compared to the same period in the prior year. Total revenues increased to $57.6 million for the full year 2024 from $50.6 million for the full year 2023. This 14% increase in revenue was primarily driven by increases in license and royalty revenue due to the recognition of deferred revenue from the termination of licensing and supply agreements and increases in co-development and research fees, partially offset by decreases in manufacturer and supply revenue. Excluding this one-time recognition of deferred revenue, total revenues decreased by $4.5 million or 9% year-over-year. Manufacture and supply revenue decreased to $40 million for the full year 2024 from $43.8 million for the full year 2023, primarily due to decreases in Suboxone and Sympazan revenues, partially offset by an increase in Emylif revenues from Zambon and an increase in Ondif revenues from Hypera. Excluding a one-time retroactive price increase of $1.7 million recognized in the prior year, manufacturer and supplier revenue decreased to $40 million from $42.1 million. Research and development expenses increased to $4.9 million in the fourth quarter 2024 from $2.9 million in the fourth quarter 2023. The increase in research and development expenses was primarily due to clinical trial costs associated with the continued advancement of the Anaphylm development program. Research and development expenses increased to $20.3 million for the full year 2024 from $13.1 million for the full year 2023. The increase in research and development expenses was primarily due to clinical trial costs and product research expenses associated with the continued advancement of both the Anaphylm and AQST-108 programs, as well as increase in personnel cost and an increase in share-based compensation. Selling, general and administrative expenses increased to $16 million in the fourth quarter of 2024 from $9.6 million in the fourth quarter of 2023, primarily due to increased commercial spending and regulatory fees related to the approval of Libervant for ages 2 to 5, pre-commercial preparations for Anaphylm, severance costs of $1.8 million and higher legal expenses of $1.5 million, partially offset by a decrease in insurance fees. Selling, general and administrative expenses increased to $50.2 million for the full year 2024 from $31.8 million for the full year 2023. The increase was partially driven by severance costs of $2.9 million and higher personnel costs. The remainder of the increase is largely driven by higher commercial spending and regulatory fees related to the approval of Libervant for ages 2 to 5 and pre-commercial preparations for Anaphylm, partially offset by a decrease in insurance fees. Aquestive's net loss for the fourth quarter of 2024 was $17.1 million or $0.19 for both basic and diluted loss per share compared to the net loss for the fourth quarter of 2023 of $8.1 million or $0.12 for both basic and diluted loss per share. Aquestive's net loss for the full year 2024 was $44.1 million or $0.51 for both basic and diluted loss per share compared to the net loss for the full year 2023 of $7.9 million or $0.13 for both basic and diluted loss per share. The increase in net loss for both the fourth quarter 2024 and full year 2024 was driven by increases in selling, general and administrative expenses; research and development expenses; noncash interest expense related to the amortization of the debt and royalty obligation discounts; and decreases in revenues, partially offset by increases in interest income and other income and decreases in manufacture and supply expenses and loss on the extinguishment of debt. Non-GAAP adjusted EBITDA loss was $11 million in the fourth quarter 2024 compared to non-GAAP adjusted EBITDA loss of $2.8 million in the fourth quarter of 2023. Non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, was $6.6 million in the fourth quarter of 2024 compared to a non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, of $0.1 million in the fourth quarter of 2023. Non-GAAP adjusted EBITDA loss was $23 million for the full year 2024 compared to non-GAAP adjusted EBITDA loss of $11.6 million for the full year 2023. Non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, was $4 million for the full year 2024 compared to non-GAAP adjusted EBITDA income excluding adjusted R&D expenses of $1 million for the full year 2023. As of December 31, 2024, cash and cash equivalents were $71.5 million. On a pro forma basis, the company's cash and cash equivalents were approximately $93 million adjusted for the $21.4 million raised through the company's ATM facility on February 14, 2025. The recent ATM activity continued our goal of strengthening our balance sheet as we prepare for the commercial launch of Anaphylm, if approved by the FDA. This sale of stock under the ATM facility was a result of inbound interest from two high-quality institutional healthcare investors, one being an existing investor. Their additional investment in Aquestive shows confidence in our story and our goal of getting products in the hands of patients. Our focus in 2025 is on the advancement of our Anaphylm and AQST-108 development programs and continued commercialization of Libervant for patients ages between 2 years and 5 years. As outlined in the press release issued last night after market close, our outlook for 2025 is: Total revenues of approximately $47 million to $56 million and non-GAAP adjusted EBITDA loss of approximately $46 million to $53 million. Our revenue guidance for 2025 includes Libervant for ages between 2 years and 5 years and some level of erosion in the demand for Suboxone. As a reminder, our 2024 revenue included onetime nonrecurring recognition of deferred revenue related to the termination of certain licensing and supply agreements. Our non-GAAP adjusted EBITDA loss guidance for 2025 includes significant pre-commercial spending for Anaphylm, costs associated with the submission of the Anaphylm NDA and related filing fee, completion of the Anaphylm pediatric clinical trial, preparations for a potential advisory committee meeting if required by the FDA for approval of Anaphylm, commencing the AQST-108 Phase 2a clinical trial in the second quarter of 2025 and continued commercialization of Libervant for epilepsy patients between ages 2 years and 5 years. With that, I will now turn the line back to the operator to open the line for questions.

Our first question comes from Roanna Ruiz with Leerink Partners. Your line is open.

This is Nick Gasset on for Roanna. Thanks for taking my questions. Maybe first from us, could you remind us what are some of the key topics that the FDA might want to clarify or dig into a potential advisory committee meeting? And what gives you confidence in Anaphylm's profile, I guess, from a PK/PD standpoint heading into this potential meeting?

Sure. Good morning, Nick. Nice to hear your voice. It's been an interesting process with the team here as we put the NDA together and starting to submit it to the FDA. And one of the outcomes of that is we've just continued to grow more and more constant in the profile of our product and that, that profile is the preferred and best profile for someone who is experiencing an allergic reaction. And when you think about it, it's really just common sense. We all know that epinephrine stabilizes mast cells and stops mediator release. We all know that without epinephrine, mast cell degranulation accelerates, it can be life-threatening and what some of you may not know is that when there is a bad outcome from an allergic reaction that, that typically almost always happens in the first 30 minutes and that's due to a drop-in blood pressure or blocked airway. So, when you look at our profile, we have a fast and rapid uptake of epinephrine. We have a rapid change in blood pressure. We've shown that localized epinephrine rapidly reduces mucosal edema. And we love this comparison to the products that are out there. We think the ability in that first 15 minutes to say that we are comparable to the auto-injector, it's really powerful. And we also think going, back to the common-sense approach, that on an individual basis when you ask someone what would you want? The obvious answer is, "I want something that gives me enough epinephrine to ensure that I stop the allergic reaction that I have." So, when we get to the Ad Comm, we believe that we'll have the opportunity to tell our story on our profile, and we think that will be received really very positively, not only by the Ad Comm, but by the other involved constituents of that day. So, we're looking forward to the Ad Comm if it does occur.

Got it. And then maybe a second question for me. I guess like thinking ahead to a potential approval and launch, which types of patients do you think would be the early adopters of Anaphylm over some of the other approved and commonly used epinephrine products that are out there?

Right. Well, look, I'll hand it over to Sherry in a second to give you her view. But I will fully admit my view is that anyone and everyone who is at risk of having anaphylaxis. One should carry a rescue product into our Rescue product absolutely should fit whatever profile that individual will have. But I'll let Sherry give you some of her thoughts.

As you know, we spent a lot of time at this past weekend, posters, dozens of one-on-ones with key opinion leaders and allergists and what we continue to hear over and over again is that because Anaphylm is the easiest to carry, it works so quickly and it's not a device that it has really opened the door to all patients. And so, we're really excited about that from a marketing segmentation perspective, look, we definitely believe anybody starting at the age where kids start carrying a phone that would certainly be a primary target and then going up, but there will be lots of opportunities and options for all patients who want to carry Anaphylm. So again, we feel very strongly that it is a very broad market for Anaphylm because of how easy it is to carry and to use. And certainly, there will be certain segments that, again, teenagers, young adults, men that will certainly want to be able to have it in their pockets, in their phones very, very quickly.

Our next question comes from David Amsellem with Piper Sandler. Your line is open.

So, just got a few. First on commercialization. Just wanted to clarify, so it sounds like you are full steam ahead in terms of building your commercial infrastructure, but you are open to some sort of partnership arrangements. So, I just wanted to get a sense of how likely some sort of partnership is versus just going it alone? That's number one. Number two, regarding the launch of neffy, any sort of early learnings that you gleaned from that launch in terms of how you're thinking about your opportunity, particularly interested in the extent to which the availability of neffy is expanding the market and any evidence of that? So that's number two. And then lastly, on Libervant, and I know I had asked this question a bunch of times, but I think it bears asking again is just how are you thinking about this asset, just given all the other things you have going on in the organization? And is that something you're looking to out-license? Thanks.

Sure. Thanks, David. So, let me first tackle your question on commercialization going it alone versus having a partner, and then I'll pass it over to Sherry, who can give you her thoughts on what she's seen with the competitor launch and your questions there. So first, as Ernie outlined in his prepared comments, our financial guidance for the year is based on us launching Anaphylm on our own. So, we are investing significant time, resources, energy money in the second half of this year to make sure that we are ready to launch as soon as that approval comes through in the first quarter of 2026, which by the way, as a reminder, is before the allergy season next year. So great timing from our perspective to launch. The likelihood of which path we take is a really hard one, right? Because our role here as a management team is to maximize the value of Anaphylm for all stakeholders. And that value, obviously, heavily includes investors and what is good for them, but it also includes patients and making sure that we can get to the broadest scope of patients that we possibly can. So, we're prepared to do that on our own, and we've lined up the plan and the spending to do that. But if the right match comes along to make us bigger, bolder and be able to get the product out further, we absolutely will engage in that. So, we'll see as the months go by, and I'll keep you and everyone else as informed as I can. Now let me pass it over to Sherry to talk about what you've seen with the competitor launch.

Good morning. So, as you know, and then we saw out at this past weekend, awareness of alternatives to the needles and auto-injectors, remains key, right? It's about a strong message about what else is now available. So, I would say physicians are asking the question is the product going to work? And so that's the key. We feel very strongly that we have the data upon approval that we will be able to share with physicians that it works. We have what I believe is the most robust package ever filed for epinephrine. We have the OASIS study that is very supportive. And so, as we're seeing the ARS launch of neffy, they're driving messaging to ATPs, they'll be launching consumer campaigns. And so overall, working to get the switches and build the market. That's a good thing. As it relates to neffy and ultimately to Anaphylm, the payers are the key. And so, we know that it is critically important to ATPs of patients to have full access to their epinephrine product. We have heard loud and clear that Anaphylm is a game changer for patients because time is of the essence in this life-threatening situation. And physicians believe that the product will be carried more often and used earlier. And so, it's our responsibility and why we have brought in-house expertise in our most recent hire new VP of Market Access, who has 25-plus years of launching 20-plus products at big and small pharma to help us do this because it is a key area of focus. We know it is for ARS and it will be for us as well.

David, I believe your last question was about Libervant. Unfortunately, Libervant has repeatedly struggled despite its value to patients. I still believe in the value of Libervant for patients just as much, if not more, than I did years ago. There will come a day when we can offer Libervant to all patients, and we look forward to that day, as it will be beneficial not only for patients but also for our organization. Regarding its role in Aquestive's broader strategy, we find ourselves at an interesting crossroads. We have significant value in several areas, and it will be interesting to see how that value contributes to the company's growth over the next 12 to 24 months. Libervant is important and will continue to be so, and its role in our organization will become clearer over time.

Our next question comes from François Brisebois with Oppenheimer. Your line is open.

Thanks for taking my question. Congrats on the progress here with the submission. I just wanted to touch on something you just mentioned on David's question about the importance of the timing of the launch. Can you just help us understand what that means and how seasonality is important for this specific market? And then I have a follow-up.

Sure. Yes. Let me pass it over to Sherry, Frank.

Look, I think that we are going to launch at a perfect time. So, there is seasonality. The epinephrine market, there is this big seasonality in the epinephrine market. So, you see, and I'm sure you see from the same numbers I do, that the market starts to build in the April, May time frame, getting ready for camps. The true season begins in mid-summer and then really peaks August and September. So, as we think about launching early, assume we have a PDUFA date early February, will be our coming out party and we'll be right in time for the season. And especially if you think about 6 months in, it will be right at that time where patients are going in for their refills, getting their new prescriptions for back-to-school, and so we think it is a great timing. You may be saying, "Well, what about payers then?" Again, this is why we have brought in-house expertise to really ensure that we are working with the payers today to prepare us as best as possible for that launch, hopefully, next February of 2026.

Excellent. And then you discussed the importance of the rapid onset and being comparable to EpiPen and the importance of the start. But another topic that comes up sometimes when people think about the Ad Comm and what might be important and you guys have mentioned is, is on the safety front. So, I was just wondering if you could share a little bit more about what makes you feel comfortable about the PK/PD profile, on the safety front? And especially with emphasis on kind of the Cmax on the but especially on the repeat dose and just what makes you comfortable with those levels of epinephrine? Thank you.

Thank you, Frank. Sherry mentioned something earlier that I think needs more attention. This is the most comprehensive package for epinephrine submitted to the FDA. Our film contains over 900 dosing, and we have twice as many subjects in our package compared to the recently approved nasal spray. We are very pleased with the robust submission we have made to the FDA, which, from our perspective, shows a clean adverse event profile with no serious adverse events. We are very excited about the package we've created. You brought up the rapid onset with the first dose, which is crucial. It's important to focus on the initial dose. Some in this field discuss the approach of bracketing to gain approval, but the drawback of bracketing is that it allows for a lower response in the first 15 or 30 minutes, which we believe is critical for preventing mortality. The mortality rate has not changed in decades, indicating that we need to ensure patients receive a substantial dose of epinephrine in those first critical minutes. We do not apologize for the quantity of epinephrine in our first and second doses—this is precisely what we believe patients require. Regarding the second dose and concerns about epinephrine levels, if a second dose is needed, that means time has passed, and the disease state has progressed. The process of mast cell degranulation has advanced, putting patients in a more serious situation. A significant amount of epinephrine is necessary to break that cycle. Carl and the team are finalizing everything, and we believe that during the Advisory Committee meeting, we will present a compelling narrative that aligns with the science and data supporting our profile, which we consider to be the preferred option for patients.

Okay. Great. And just maybe to finish on that, is that the level that we've seen with the curves, is that still a physiological range of epinephrine in the body or are we talking about super physiological here?

Yes. So, I'll pass that over to Carl to give his view.

Yes. No, appreciate the question. And when you say physiologic range, obviously, the human body is well designed to address various stress states. So, if you go for a run, obviously, your epinephrine levels are going to rise. And if you're resting at home, it's obviously going to go down. The pharmacokinetic profile of epinephrine is such that we see linear kinetics for pharmacokinetics, but hemodynamic pharmacodynamics, it's not linear. I mean you reach a threshold to whatever epidemic levels you have in your body, at some point, trees don't grow ever taller, you don't have your heart rate, your blood pressure going ever higher. So, there is a threshold that's reached, but those levels that are required to make sure you address stress situations we're built for that. I don't foresee any concerns outside the physiologic range right now.

Our next question comes from Kristen Kluska with Cantor Fitzgerald. Your line is open.

Hi, good morning, everybody, and thanks for taking my question. The first is, can you speak a little bit more about some of the potential pre-Ad Comm work that you're doing? I think you're in a pretty unique situation having a list of all the unsolicited FDA comments from the pre-NDA meeting. Have you considered hiring any of the Ad Comm services or conducting a mock Ad Comm yourself ahead of this potential event?

Thank you, Kristen. As you know, the advisory committee process with the FDA follows a specific format. There is a structured agenda for the day, and every advisory committee meeting adheres to that process. We have engaged external experts to ensure we are well-prepared for each segment of the day. Additionally, our internal team meets weekly to review each aspect. Although we don't anticipate the advisory committee meeting to take place until the fall, we are committed to being ready well ahead of time. Preparing for this event is a significant undertaking for the company, but if the advisory committee does occur, it will provide a valuable opportunity for us to highlight the strengths of our program.

Okay. And as you're doing a lot of the work getting in front of physicians at conferences, et cetera, we often talk about the current EAI market. These patients obviously understand the seriousness and need to carry a form of epinephrine, but as we start thinking about the market shifting into needleless forms, how would you think in the future about penetrating into those markets where patients know that they have a serious condition, but they know that they didn't want to carry a needle or they were afraid of a needle or it was too large, et cetera? Do you think there could be an uptick in that sale relative to what we would naturally expect as a big shift from patients also on EAIs right now?

Yes. Well, I'll pass it over to Sherry in a second to give her thoughts, but I'll just give one global thought, which is, as we, again, as we've been putting the NDA together in preparing all the pieces and parts for the FDA. One thing that continues to strike me is the number of times that anaphylaxis occurs including where there's the ultimately bad outcome of that, where the individual had never been prescribed a rescue product and didn't even know they needed a rescue product. So, in terms of just globally, there absolutely is a need for much greater awareness to protect people. But Sherry could talk more about how that manifests itself in the marketplace.

Based on our extensive market research, as Dan mentioned, our recent ATU, and the one-on-one meetings I had with numerous physicians this past weekend, I believe there will be a notable shift in perspective. Currently, many view the choice as between a needle and a non-needle option. However, our findings suggest that the market will transition from traditional devices to oral solutions. This is crucial because the oral solution is not merely a pill; it is an oral film that can be easily carried on the back of a phone, an item people have with them at all times. I am confident this product will see growth as Anaphylm is the most convenient and user-friendly option that functions effectively in life-threatening situations. I firmly believe we will witness a gradual transition from traditional devices to an oral film format. That’s my perspective on the matter, Kristen.

Our next question comes from Jason Butler with Citizens JMP. Your line is open. I believe this will grow because Anaphylm is the easiest to carry and use, and it will work quickly in life-threatening situations. I'm very optimistic about it. I anticipate a shift over time from device carrying to the film or oral format. That's my perspective, Kristen.

Hi. Thanks for taking my questions. Just a couple for me. So first on Libervant. How do you think about investing in the product commercially following the court decision last month and how could that change throughout 2025? And then just on Anil, can you talk about what additional awareness work you can do this year? Obviously, was an important meeting, but what additional work you'll do to prepare for the launch? Thanks.

Sure. So, on Libervant, so for me, the biggest thing to keep in mind on Libervant. And it's interesting in this industry. Sometimes people forget that we are our ultimate purpose is to actually improve patients' lives. So, when I look at Libervant, we're very proud here that we have a product that we think is meaningful to patients does save patients' lives and helps in a spot where we're talking about 2- to 5-year-old children. So, my focus right now is on making sure that we do everything we can to ensure patients in that age group who are using our product, continue to be able to use our product. Over the mid- to long term, once that's sorted out, we continue to believe that Libervant is useful and meaningful for all age groups. And you'll see us look to make sure patients have access to that. Now how they have access, whether it's to your question on investing in more commercial infrastructure or partnering or finding another way to provide access to patients, we're always on every product, always looking at what's the best way to do that. But my primary focus right now is how do we make sure patients continue to have access to a product that we think is very important to them. On Anaphylm awareness and the activities that we'll be focused on this year, I'll pass it over to Sherry, again.

Thank you, Dan. As we mentioned, we have been attending college conferences and investing significantly in our medical presence. This includes not just major conferences but also numerous regional and local events to ensure that our message about Aquestive and Anaphylm as a groundbreaking option for patients is communicated effectively when it becomes available. We have been conducting continuing medical education and non-continuing medical education initiatives to raise disease state awareness. Our medical team is actively engaging with customers and key opinion leaders across the region to strengthen our messaging. Additionally, we are establishing strong relationships with advocacy organizations in this space, and based on my prior experience as well as the expertise of our Aquestive team members, we have developed meaningful connections with these organizations. We will remain active at their events as we prepare for the launch.

Our next question comes from Raghuram Selvaraju with H.C. Wainwright. Your line is now open.

Thanks for taking my questions. Congrats on all the recent progress. I just wanted to see if you could comment on sort of what so far has been the commercial experience with the epinephrine nasal spray? What you've been hearing with regard to whether or not that product has outperformed expectations? And in particular, if you could talk about the promotional activities that have been undertaken in support of that product and what relevance those might have to your potential future launch of Anaphylm? As an example, there is a fair amount of DTC activity going on in support of that product. Just wanted to see how that fits into your thinking regarding the future marketing campaign for Anaphylm as and when it gets approved. And if there's any granularity you can provide to us at this time regarding what you expect and implies promotional budget to be for a product like Anaphylm, once it is approved in the United States?

Yes. Let me share my thoughts following Sherry's insights on the market. Regarding expectations for the commercial experience and performance of competing products, I'll let our competitors communicate how they view their results. From our perspective, there is a substantial need to build awareness in this space. This awareness benefits everyone involved as it helps those who are not currently using solutions understand that there are alternatives available. Additionally, it provides options for those who are currently using solutions but are dissatisfied. Significant investments are being made to raise this awareness, which we are pleased about and hope continues, as it will support the entire market. We are hearing from physicians that they want assurance the product is effective, which poses a challenge when efficacy studies are not feasible and a 505(b)(2) comparability package is employed. This year, we will focus extensively on our OASIS study, where we demonstrated that edema was resolved, I believe, in just 5 minutes. This unique study shows significant benefits for patients experiencing allergic reactions in their oral cavity, and we are very excited about these results. Regarding DTC spending, one advantage of a drug like Anaphylm is its flexibility. There is likely a correlation between spending and outcomes, so as we scale and secure larger DTC budgets, we expect continued growth. We won’t begin with a large DTC budget, as we must be mindful of our balance sheet, but we anticipate it will be sufficient to enter a growth phase for Anaphylm, enabling us to develop it over time.

That's very helpful. With respect to Libervant, I just wanted to clarify, the court decision, a, it seems as though the court is going off of the orphan drug exclusivity for Valtoco and it's not paying attention to the demarcation between the Valtoco label and Libervant label. Is that correct?

Yes, when it comes to courts, there's always uncertainty about the outcome. It's unpredictable what a judge or appeals court will decide. The main point is that we recognize that getting Anaphylm approved by the FDA is essential while we continue to develop our organization. Additionally, we believe Libervant is crucial for patients, so we are committed to fighting in the courts to ensure continued access for them. However, the unpredictability of the court system means we won't know the final outcome until it's resolved.

But in any case, just to clarify, while the appeal process is ongoing, there is no change to the authorization that Libervant currently has. Is that correct?

It ultimately depends on the judge and the decisions they make as we move through the process. There are many possible outcomes, and like all of you who are listening, we are also waiting to see where the judge will lead us.

And then just in terms of how long it could take for the appeals process to play out, can you just contextualize that for us in the context of the timing with which the ODE for Valtoco is slated to expire?

Yes. Well, look, so let's start with when the ODE for Valtoco expires, right? That is in early 2027. So, we, on a global product basis, will be ready to provide Libervant to all age groups when that day comes. And none of this court exercise will change that. In terms of how long an appeal process takes right now for the 2- to 5-year-old space on Libervant, I hate to give guidance on that. I think the courts at times can move very slowly, at times can move very fast. And all we can do is keep pushing to make sure patients have access and that's what we'll do.

Okay. Then just very quickly for Ernie. As has been the case in years past, you've provided a relatively wide top-line guidance range. I was just wondering if, a, you expect as has been done previously to narrow that range as we go further into 2025? And b, if you could maybe give us some sense of what the tailwinds might be that you are factoring into driving the company's top-line performance towards the upper end of that range? In other words, what could be the factors that drive you towards that $66 million number as opposed to the $47 million number?

So, one thing to keep in mind this year is the revenue from Libervant, which is estimated to be between 4.2 and 5 million. As discussed regarding the court case, this could influence our guidance as the year progresses. Regarding Suboxone, I mentioned in my script that we have anticipated some level of erosion, as we typically do. We are currently uncertain about the potential for increased generic competition for Suboxone. As the year advances, we will gain insights into how the market stabilizes for Suboxone and the orders we receive from Indivior, which will affect our guidance. We will certainly consider tightening the range as we move forward.

Thank you.

Our next question comes from Gary Nachman with Raymond James. Your line is now open.

Great. Good morning. So back to the Ad Comm, as you're preparing for it, you specifically called out some decent spending behind that, Dan, it sounds like you're now leaning much more to the likelihood that you'll have the Ad Comm. So, has there been any more guidance from FDA on that as you've been preparing the filing or are you just being extra cautious on this? And then I have some follow-ups.

Yes. we have no additional insight from the FDA. We are we're doing what good stewards of a company should do and preparing without thought of whether it will or will not happen. And obviously, ultimately, it's up to the FDA whether they decide to have it or not.

Okay. And then you said you saw some initial data from the pediatric study for Anaphylm that you said was in line with expectations. Any more color on that? And when will you have the final data just to ensure there are no issues there for the filing? And then on commercial, if you end up commercializing Anaphylm on your own how many reps will you need? And then how quickly will we be able to get them on board after the approval to launch very quickly there?

Right. Well, I'll pass it over to Carl in a second, I know you've been dying to jump in on the pediatric study, so thank you for that question, but I'll just give a timing answer. In terms of the pediatric data, we have a big chunk of it right now. We're getting more shortly. And in terms of making sure the NDA, we have that timing mapped out so that there's no issue, but I'll let Carl give you his thoughts on what he's seeing.

Yes. No, I appreciate the question. And as Dan already stated, the intention is to provide the necessary elements of the pediatric study into the filing that is certainly completely on schedule. The profiles we're seeing from the pediatric study are completely in accord with our expectations and for the requirement of submitting the filing as already stated, we will have the necessary data from the pediatric study to support it. So, we're extremely pleased not only with the timing but also the data that we're seeing coming out of that study.

And I think the next part of your question, Gary, was on the number of reps. I'll let Sherry give you her thoughts on how she would build up to the right amount. But just as a reminder, we've given clear guidance, we will not hire a single sales rep until after approval, but Sherry can take it from there.

Thanks, Gary. As you think about the number of allergists that are practicing as well as some very kind of high decile pediatricians, some PCPs and nurse practitioner PAs, we believe in that around 100 mark is a good number for us to start with as far as the sales force. They go up, they go down, they folks. But overall, to cover the most important customers, I think we're at a sweet spot of about 100. So that's first and foremost. And as Dan mentioned, we would not make offers until after approval. However, we will spend a good deal of time in Q4 preparing to make those hires, so that upon approval, we would be ready to hire.

Okay. And then just last question back on the partnership discussions that you're having. Is it possible that you could have a full global partner for Anaphylm or that it would more likely be split up by geography, U.S. versus ex-U.S.? And then, Dan, maybe you could just give a little bit of color just the type of partnership that you think would make sense. It's probably a lot of different iterations there. But if you do sign someone in the U.S. and you decide to go down that test. What do you think that might look like? And are you really leaning towards having a COCO where you would also have a commercial presence? Is that an important piece of it?

Yes. Regarding the U.S., we won't provide comments on that. If we consider a partnership, it will only be with organizations that have significant capabilities and a strong commitment to the therapeutic area. These are essential criteria for us. Whether we end up finding a global or U.S. partner, there are large companies that meet these criteria and could potentially serve either market. It's important to note that outside the U.S., we are focused solely on partnerships. So, there is a distinction between the two situations.

Okay. And I mean, just in terms of timing, I know this might be a difficult question to answer. But do you think you could have a partnership in place before there would be an Ad Comm, if there is an Ad Comm? Just because you are spending a lot behind all your prelaunch activities, so you have to manage that with the possibility that you could have a partner that would share in that. So, is it reasonable to think that people would want more visibility on the path forward? Or do you think there's enough there where you could potentially execute it sooner?

Yes, Gary, you and I have known each other a long time, right? I learned long ago, you don't run a business based on trying to do something by a date, right? So, we're not focused on any particular date or any moment in time or inflection point of you have to do something here or not do something. We have our path, we have our plan, we're very fortunate to have not only Sherry, but people under Sherry who are very talented. We're more than happy to bring this to market ourselves. And if the right partner comes along that can augment our ability, we'll do that. If they don't, we won't. So, there's no timing element to that, that we will force ourselves or anyone else to.

Our next question comes from Thomas Flaten with Lake Street Capital Markets. Your line is now open.

Just a follow-up on a couple of questions have been asked already. Sherry, back to the hiring of the sales force and the very peculiar seasonality associated with this type of product. When would be the optimal time then assuming a February PDUFA date, like you had said in an earlier response, would you want to have those reps out in the field?

If we consider the early phase, we would anticipate being ready by the end of February 2026, as the season is starting to ramp up. Therefore, we intend to complete all the necessary preparation work before the PDUFA date and then hire the sales representatives immediately after that.

Yes. So, the initial approval will be for patients 30 kilos and up, which is about 7 years of age. And that will be comparable to the adult dose of the EpiPen the adult down to 30. So that's just one dose. We will, after that, just like the other companies around us put a junior dose through its paces that the FDA bring that to market. So, at launch next spring, there will be one dose. Over time as we take a view of the whole market, there will ultimately be two doses.

Our next question comes from James Molloy with Alliance Global Partners. Your line is now open.

Ernie, I have a quick question related to the earlier partnership topic. Regarding the $16 million G&A spending in the fourth quarter, should we expect that level to continue going forward? Is that amount dependent on having a partner for Anaphylm, or will it revert to the $12 million level through 2025?

In the fourth quarter, there was a severance charge that affected the numbers. Looking ahead to 2025, as mentioned in my prepared remarks on our guidance, we have factored in costs for the pre-commercial work for Anaphylm, which Sherry referenced earlier. We are also continuing the commercialization of Libervant. We anticipate an increase in our SG&A, particularly in the second half of the year, as we advance the pre-commercial work for Anaphylm.

Great. And for my last question on Libervant, is there any risk associated with marketing it, considering the rollout? I know you mentioned uncertainty regarding the courts. What are your thoughts on the timing and any risks involved in continuing to market Libervant after this recent ruling?

Yes. The primary risk in marketing Libervant is related to the court system. Similar to my response regarding the timing of a potential partnership for Anaphylm, the situation with Libervant is also dependent on the courts. There are aspects we can manage, but the timing and decisions made by the court system are out of our control. We are dedicated to the patients in this area, believe strongly in the importance of our product, and will continue to advocate for them as we navigate the situation.

I'm not showing any further questions at this time. I'd like to turn the call back over to Daniel Barber, CEO, for any closing comments.

Thanks, Kevin. Thank you for joining us this morning. As you heard today, we're incredibly excited about the progress the company has made, and we believe we are well-positioned for a successful 2025. We look forward to the next time we interact. And with that, I wish all of you a wonderful day.

Thank you. Ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.