Aquestive Therapeutics, Inc. Price & Performance (AQST)

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.

We are going to provide an overview of recent business developments and performance for the fourth quarter year ended 2024 followed by a Q and A session. During the Q and A session, the team will be joined by Doctor. Carl Krause, Chief Medical Officer Doctor. Steven Morgaki, Chief Science Officer and Sherry Korchinsky, Senior Vice President, Sales and Marketing. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call will be made available on the Questis Aquestive 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 twenty twenty four 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 Aquestions Aquestive. [indiscernible] the call, the company will 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 ks.

Filed with the Securities and Exchange Commission on 03/05/2025. 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 Anafilm if approved by the FDA right on schedule, in the first quarter Today represents the achievement of a major milestone for our company colleagues, [indiscernible] This achievement was years in the making by scores of dedicated people with 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. ANA Film was built to meet these needs and because of this, we believe patients will ultimately choose ANAFILLM as their preferred product.

Our plan is that less than a year from now, Anafilm 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 ANAFILM has progressed as expected Our NDA will include the necessary pediatric data to support a product label that if approved by the FDA would mirror the weight and age parameters of the existing zero point three milligram 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 Anafilm, In addition, have begun preparing for a potential advisory committee meeting for Anafel. 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 the second half of twenty twenty five, 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 [indiscernible] We recently conducted an awareness Trial and Usage or ATU study 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, ninety two percent of the 125 physicians that were interviewed were aware of the FDA approved nasal spray product. Roughly sixty five percent of these physicians had already written a prescription for the nasal spray. Yet, when asked to allocate their 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 with STILLIFT 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 and marketing efforts that occurred after approval. Now let's turn to commercialization. We believe there are multiple pathways to commercializing ANNOFIN if approved by the FDA.

We continue to prepare for launching Anafilm 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 Anafilm 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 we'll 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 Anafil. Once we have completed our Anifil 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 ANAFILM 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-one hundred and eight, our topical gel formulation that's an effort. As previously discussed, we believe that AQST-one hundred and eight 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-one hundred and eight 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 six point seven million people in The U. S. Are affected by AA. Of those affected, forty three percent are considered severe The existing therapies for AA are Janice Kinesor 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 $1,000,000,000 As Anaphylme comes to market, if approved by the FDA, we expect HUSD-one hundred and eight 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 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 We have more levers of growth than ever before in the history of the company. We expect to realize the following milestones the coming months. FDA acceptance of our Anafilm NDA submission opening of our IND for AQST-one hundred and eight and the start of our Phase 2a clinical trial engagement with international regulatory bodies for expanding ANAFILM filings to ex U. S. Territories, continuing to build towards the commercial launch of Anafil if approved by the FDA and continuing to fight patient access [indiscernible] With that, 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 twenty twenty four And full year 2024 results, in the Q and A. During 2024, we made great progress in positioning Aquestive for success. We strengthened our balance sheet by raising over $78,000,000 in capital from high quality institutional healthcare investors. That allowed continued investment in our strategic priorities including advancing the development of Anafilm, 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-one hundred and eight a topical gel formulation, Now let's turn to the recap of our quarterly and full year financial results. Total revenue decreased to $11,900,000 in the fourth quarter twenty twenty four, $13,200,000 in the fourth quarter twenty twenty three. This 10% decrease in revenue was primarily driven by decreases in license and royalty revenue Due to $1,000,000 of milestone royalty revenue for Astaris from Zebra Therapeutics recognized in the prior year.

Manufacture and supply revenue decreased to $10,700,000 in the fourth quarter twenty twenty four from $11,000,000 in the fourth quarter twenty twenty three primarily due to a decrease in SUBOXONE revenues partially offset by an increase in revenue for Ondi from Hypero. License and royalty revenue decreased $800,000 in the fourth quarter twenty twenty four from $1,900,000 the fourth quarter twenty twenty three primarily due to the previously mentioned royalty revenue recognized in the prior year. Co development and research fees in the fourth quarter twenty twenty four remained relatively unchanged compared to the same period in the prior year. Total revenues increased to $57,600,000 for the full year 2024 from $50,600,000 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 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 $4,500,000 or 9% year over year. Manufacture and supply revenue decreased to $40,000,000 for the full year 2024 from $43,800,000 the full year 2023. Primarily due to decreases in Suboxone and SYMPAZAN revenues partially offset by an increase in MLIF revenues, from Zambone and an increase in OnDeaf revenues from Hypera.

Excluding a one time retroactive price increase, of $1,700,000 recognized in the prior year, manufacturer and supply revenue decreased to $40,000,000 from $42,100,000 Research and development expenses increased to $4,900,000 the fourth quarter twenty twenty four from $2,900,000 in the fourth quarter twenty twenty three. The increase in research and development expenses was primarily due to clinical trial costs associated with the continued advancement of the antifilm development program. Research and development expenses increased to $20,300,000 for the full year 2024 from $13,100,000 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 ANAFIM and AQST-one 80 programs. As well as increase in personnel cost Selling, general and administrative expenses increased to $16,000,000 in the fourth quarter twenty twenty four from $9,600,000 in in the fourth quarter twenty twenty three. Primarily due to increased commercial spending in regulatory fees related to the approval of Libervant for ages two to five, Pre commercial preparations for ANAFILLM severance cost of $1,800,000 and higher legal expenses of $1,500,000 partially offset by a decrease in insurance fees. Selling, general and administrative expenses increased to $50,200,000 for the full year 2024 thirty one point eight million dollars for the full year 2023.

The increase was partially driven by severance costs of $2,900,000 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 two to five, and pre commercial preparations for ANAFILM partially offset by a decrease in insurance fees. Aquestive's net loss for the fourth quarter twenty twenty four was $17,100,000 or or $0.19 for both basic and diluted loss per share. Compared to the net loss for the fourth quarter of twenty twenty three, of $8,100,000 or $0.12 for both basic Aquesta's net loss for the full year 2024 was $44,100,000 or $0.51 for both basic and diluted loss per share. Compared to the net loss for the full year of 2023, of $7,900,000 or $0.13 for both basic and diluted loss per share. The increase in net loss for both the fourth quarter twenty twenty four and full year 2024, was driven by increases in selling, general and administrative expenses, research and development expenses, non cash 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 manufacturing of product expenses and loss on the extinguishment of debt.

Non GAAP adjusted EBITDA loss was $11,000,000 in the fourth quarter twenty twenty four Compared to non GAAP adjusted EBITDA loss, of $2,800,000 in the fourth quarter twenty twenty three. Non GAAP adjusted EBITDA loss excluding adjusted R and D expenses was $6,600,000 in the fourth quarter twenty twenty four compared to a non GAAP adjusted EBITDA loss excluding adjusted R and D expenses of $100,000 in the fourth quarter of twenty twenty three. Non GAAP adjusted EBITDA loss was $23,000,000 for the full year 2024 compared to non GAAP adjusted EBITDA loss of $11,600,000 Non GAAP adjusted EBITDA loss excluding adjusted R and D expenses was $4,000,000 for the full year 2024. Compared to non GAAP adjusted EBITDA income excluding adjusted R and D expenses of $1,000,000 for the full year 2023. As of 12/31/2024, cash and cash equivalents were $71,500,000 On a pro form a basis, the company's cash and cash equivalents were approximately $93,000,000 Adjusted for the $21,400,000 raised through the company's ATM facility, on 02/14/2025. The recent ATM activity continued our goal of strengthening our balance sheet as we prepare for the commercial launch if approved by the FDA. This sale of SaaS 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 Anafilm and AQST-one hundred and eight development programs and continued commercialization of Libervant, for patients ages between two and five years. As outlined in the press release, issued last night after market closed, our outlook for 2025 is total revenues of approximately $47,000,000 to $56,000,000 and non GAAP adjusted EBITDA loss of approximately $46,000,000 to $53,000,000 Our revenue guidance for 2025 includes Libervant for ages between two and five years and some level of erosion in the demand for As a reminder, our 2024 revenue included onetime non recurring 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 Anafilm Costs associated with submission of the ANAFIMM NDA and related filing fee completion of the ANAFILM pediatric clinical trial, preparations for a potential advisory committee meeting if required by the FDA for approval of ANNOFILM commencing the AQST-one hundred and eight Phase 2a clinical trial in the second quarter of twenty twenty five, and continued commercialization of Webervan for epilepsy patients between ages two and five years.

With that, I will now turn the line back to the operator Our first question comes from Rowena Ruiz with Lyric Partners. Your line is open. Hey, good morning. This is Nick Gassik on for Rowan. Thanks for taking the 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 at a potential advisory committee meeting And what gives you confidence in NFL's profile, I guess, from a PKPD 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 started to submit it to the FDA, And one of the outcomes of that is we've just continued to grow more and more confident 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. 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, [indiscernible] that that typically almost always happens in the first thirty 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 fifteen minutes to say that we are comparable to the auto injector is really powerful. And we also think going back to the common sense approach that on an individual basis, when you ask someone 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 ADCOM, 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 ADCOM, but by the other involved constituents to that day. So we're looking forward to the AdCom if it does occur. Got it.

Thanks, Dan.

And then maybe second question from 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 ADASLIM? Or some of the other approved and commonly used epinephrine products that are out there?

Right. 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 and two are rescue products absolutely should fit whatever profile that individual has. But I'll let Sherry give Hi, Nick. Nice to chat with you again. As you know, we spent a lot of time at QuadAI this past weekend. Four posters, dozens of one on ones of key opinion leaders and allergists. And what we continue to hear over and over again is that because ANAFILLM is the easiest to carry It works so quickly and it's not a device. That it's really opened the door to all patients. And so we're really excited about that. From a marketing segmentation Aquestive, we definitely believe anybody any starting at the age where kids starts 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 Anastyl. So again, we feel very strongly that it is a very broad market for Anaphylme 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.

Got it. That's helpful. Thanks guys. I'll hop back in the queue. One moment for our next question.

Our next question comes from David Amsellem with Piper Sandler. Your line is open. Thanks. 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. Open to some sort of partnership arrangement. So I just wanted to get a sense of how likely some sort of partnership is versus just doing it alone. That's number one. Number two, regarding the launch of Nessie, any sort of early learnings that you've gleaned from that launch in terms of how you're thinking about your opportunity? Particularly interested in the extent to which the availability of nephy is expanding the market and any evidence of that 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. 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?

Sure. Thanks, David. Good to hear your voice. 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 [indiscernible] is baked on us launching Anifilm 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 twenty twenty six, 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 the management team is to maximize the value of Anafilm for all stakeholders And that value obviously heavily includes investors and what is good for them. 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 the plan and the spending to do that.

But if the right match comes along to make us bigger, bolder and be able get the product out farther, 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 to Sherry to talk about what she's seen with the competitor launch.

Good morning. So as you know, and then we saw on at Quad AI this past weekend, awareness of alternatives to the needles and auto injectors remains key, right? And so 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 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 is very supportive And so as we're seeing that the ARS launch of NEPI, they're driving messaging to HCPs, They'll be launching consumer campaigns. [indiscernible] get the switches and build a market. That's a good thing. As it relates to, Nephi and ultimately to Anafilm, the payers are the key. And so we know that it is critically important to HCP for patients to have full access to their epinephrine product, We have heard loud and clear that Anafilm 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 our new VP of Market Access. Who has twenty twenty five 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 And David, I think the last part of your question was on Libervant, which look, Libervant has unfortunately just time after time faced struggles that are outside of the value of the product to patients. Right? Today, I believe in the value of Libervant for patients. Just as much, if not more, as they did years ago. So there will come a day where we can provide Libervant to all patients and we look forward to that day and we think that will be a valuable day not only for patients but for us as an organization.

In terms of where it fits in the broader strategy of [indiscernible] I think we're at an interesting crossroads right now as a company where we have tremendous value in a variety of And I think it remains to be seen over the next twelve to twenty four months how that value grows the company. So Libervant is important. Will continue to be important. And it's placed in our organization, I think, will be clarified as [indiscernible] Okay. Helpful. Thank you. One moment for our next question. Next question comes from Francois Brisebois with Oppenheimer. Your line is open.

Hi, thanks for taking the question and 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 that over to Sherry, Frank.

Hi, Frank. Nice to chat with you again. Great seeing you. Look, I think that we are going to launch at a perfect time. So there is seasonality. The F and F brand market, there is big seasonality in the up and up front 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 timeframe. Getting ready for camps, The true season begins in midsummer and then really peaks August and September.

So as we think about launching early you assume we haven't PDUFA data early February, will Cloud AI will be our coming out party. And we'll be right in time for the season. And especially if you think about six months in, it'll 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 the 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 twenty twenty six.

Excellent. And then you discussed the importance of the rapid on set and being comparable to EpiPen and the importance of the start, but another topic that comes up sometimes when people think about the adcom and what might be important and that 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 PKPD profile on the safety front and especially with emphasis on kind of the Cmax, on the single dose, but especially on the repeat dose, just what makes you comfortable with those levels of epinephrine?

Thank you. No, thanks Frank for that. So Sherry, said something before that I think deserves a little bit more airtime This is the most robust package ever put together. For epinephrine for the FDA.

We have over 900 dosing in our film. We have twice as many subjects in our package as the competing nasal spray that was just approved. So we have a very, very robust package that we're putting in with the FDA, which has a very clean from our perspective AE profile and no SAEs. So when we look at the package we've created, we're very excited. And you mentioned the rapid onset with the first dose. And you really do have to start with the first dose. When you think about you've heard people in this space talk about this idea of bracketing. To get to approval. Well, the weakness in bracketing is it allows you to be low for the first fifteen or thirty minutes if you want to be and still get approved. We think that's the wrong profile. We think that is when mortality occurs fact, and Carl could tell you more if we had time, mortality rate hasn't changed in decades. So clearly something needs to be done to make sure you get a robust enough amount of epinephrine in that first fifteen or thirty minutes. So we don't as interesting as as you hear comments around the space, we don't apologize for the amount of epinephrine we're giving with our first dose or our second dose.

That's exactly what we think people need.

So let's talk about that second dose. And This supposed concern about the level of epinephrine. If you need a second dose of epinephrine, time has gone by You are farther into the disease state The cascade of mast cell degranulation is further along and now you're in real trouble. So you need a significant amount of epinephrine to get out of that cycle. And we think and Carl and the team are putting everything together, we think in the AdCom, that we will have a very compelling story to tell that lines up with the science and the data that we have supporting what we're our profile looks like and how it is the preferred one for patients.

Okay, great. And just maybe to finish on that, is that the levels that we've seen with the curves is that still in 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 you his view. Yes. No, I appreciate the question. And when you say physiologic range, obviously, the human body is well designed to to address various stress states. So if you go out 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 to the pharmacokinetic profile of epinephrine is such that we see linear kinetics or pharmacokinetics, but our hemodynamic pharmacodynamics, it's not linear. You reach a threshold. So whatever epinephrine levels you have in your body, at some point, trees don't grow ever taller, you don't have your heart rate and your blood pressure is 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.

Now?

Excellent. All right. Thank you. Very helpful and congrats again.

Thanks, Frank. One moment for our next question. Our next question comes from Kristen Klesska with Scantin Fitzgerald. Your line is open.

Hi, good morning everybody. Thanks for taking my Aquestive. The first one is, can you speak a little bit more about some of the potential pre AdCom work that you're doing? I think you're in a pretty unique unsolicited FDA comments from the pre NDA meeting. Have you considered hiring [indiscernible] AdCom yourself ahead of this potential event? [indiscernible] So as you know, the advisory committee process with the FDA is formulaic. So there is an order to how the day goes. And every AdCom follows that process. So we have brought on external expertise to help us make sure we are ready for each section of that day There's already team inside of our company that meets on a weekly basis to to go through the pieces and parts and while we don't expect the adcom, if it occurs, to happen until the fall, we are going to be ready well in advance of that. So look, it's a lot of work for a company to get prepared. But it is if the outcome occurs, it is a really nice day for us to be able to showcase all the great things about our program.

Okay, thanks. And as you're doing a lot of the work getting in front of physicians at conferences, etcetera, we often talk about the current EAI market. These patients obviously [indiscernible] as we start thinking about the market shifting into needle less forms, would you think in the future about penetrating into those, mark condition, but they know that they didn't want to carry a needle or they were afraid of a needle or too large, etcetera. 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 EAI right now? Thank you.

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 the pieces and parts for the FDA One thing that continues to strike me is the number of times that anaphylaxis occurs [indiscernible] where there's the ultimately bad outcome of [indiscernible] 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 market.

Hi, Krista. Nice to hear your voice. What I believe based on all of the market research that we have been conducting, Dan mentioned our recent You've as well as the meetings that we are attending and I met with dozens of physicians this past weekend one on one. And I think something that you'll see and we believe will occur right now the way people are maybe looking at this, it's about a needle versus a non needle. We believe based on our our research and our conversations is this will the market will shift from devices versus an oral. So that's a key difference all devices. When you think about not only it's not an oral pill, it's an oral film that fits in the back of your phone. And so something that you will people always have with them is their phone. And so again, I do believe this will grow because of it is the ease adafilm is the easiest to carry. It is the easiest to use It's going to work, work quickly in that life threatening situation.

And obviously, I'm very bullish about it. And but I do believe we're going to see over time a shift from device carrying the film or oral. So that's how I'm thinking about it, Kristen.

Thank you. One moment for our next question. Our next question comes from Jason Butler with Citizens JMP. Your line is open.

Hi, thanks for taking the questions. 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 twenty twenty five? And then just on Anafilm, can you talk about what additional awareness work you can do this year? Obviously, Quad AI was a important meeting, but what additional work you'll do to prepare for the launch? Thanks. Sure. Good morning, Jason. So on Libervant, for me, the biggest thing to keep in mind in Libervant [indiscernible] it's interesting in this industry. Sometimes people forget that we are our ultimate purpose is to actually improve patients' lives. So 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 two to five 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 [indiscernible] 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 Aquestive, 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 a product that we think is very important to them.

On anaphylm awareness and the activities that we'll be focused on this year outlook, I'll pass it over to Sherry again. Thanks, Dan.

So as we mentioned, we've been going to conferences, Spot.ai, the college, We're doing we're investing significantly in our medical presence So not only the big conferences, but dozens of regional and local conferences to ensure that the messaging is out about who is the Aquestive and and why Anafilm is a game changer. And will be the best choice for patients when it is available. I think some other things you want to think about is, we're been conducting CME Additionally, non CME disease state awareness work As I mentioned, dozens of conferences, other than the posters, publication, medical team that is out [indiscernible] talking to customers, KOLs, regional KOLs, we're really working to get our messaging out. Another aspect of this as we prepare for launch is the deep relationships we have with advocacy organizations. So in the space, there's four main advocacy organizations. And based on my prior experience, as well as in here at Aquestive team members, we do have significant relationships with the advocacy organizations and we will continue to be present at their event.

Great. Thank you.

One moment for our next question. Our next question from Raghuram Selvaraju with H. C. Wainwright. Your line is open.

Thanks very much for taking my questions and congrats on all the recent progress. Just wanted to see if you could comment on sort of what so far has been the commercial experience [indiscernible] 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 Hanasone. 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 campaigns campaign for Anifilm as and when it gets approved? And if there's any granularity you can provide to us at this time regarding what you expect annualized promotional budget to be for a product like Anifilm once it is approved in The United States? Yes. So let me give you my thought. You heard Sherry's thoughts before. Space. Let me give you some of my thoughts and Sure, I can round it out if need be. First on the expectations, the commercial experience and expectations from a competing product.

I will leave it to our competitor to tell the space how they feel about their performance versus expectations and don't want to don't want to shave that one way or the other for them.

What I would say in terms of the commercial experience of what we're seeing as Sherry laid out before, There is a significant need in this space to build awareness. And so and that awareness is that truly is a rising tide raises all boats in this case because it is about making sure that the people who are not carrying realize there are other solutions that may bring them back into the the market. The people who are carrying but are not satisfied with their solution. Showing them that there's something out there. So we there are big dollars being spent on awareness right now We're very happy about that. And we hope it continues and we think that helps everyone We are hearing as Sherry talked about before, that physicians want to know that the product works. And that is a difficult thing to do in a space where efficacy studies can't be performed and you're using a five zero five(two) comparability package. So for us, you'll hear us this year and we just did a quad AI focused a lot on our OASIS study, In our OASIS study, Edima was resolved And I believe I'm just looking at Carl to make sure I get the number right, but I believe in five minutes.

So we know that we have a study that no one else has in patients who are having an allergic reaction, in their oral cavity where we can show the benefit, how quickly that benefit comes through. So we're very excited about that. In terms of the last part of your question on DTC spend, one of the positives about a drug like Anifil in the space that it's in is it's flexible, right? There's literally probably a mathematical equation of more you spend, you get this, the less you spend, you get this. So we think it's a large market. As we scale and as we're able to afford bigger and bigger DTC budgets, we'll continue to grow and grow. So, we won't start out with a giant DTC budget because that's just not us. And we will be respectful of the balance sheet that we have But we think it still will be meaningful enough to get Anacel into a growth mode where we can continue to build 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 Val Toco and is not paying attention to the demarcation between the Valtoco label and Libervant label. Is that correct? [indiscernible] With courts, you're never really sure which way things are going to turn, right? So it's always kind of a coin toss of what a judge will do, what the appeals court will do, what the next judge will do, So look, we're I think the right way to think about it is we understand That NFL is something we have to get filed and get through the FDA continue to build our organization. But we think that Libervant is important to patients. And so we will continue to invest in making sure that we fight in the courts And that we get Libervant to a place where patients can continue to have access to it. Having said that, it's the court system and and you don't know until it's over. 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? Well, that's up to the judge and the courts, right? So it depends on how they what their decisions are. As we go through the process. So, there is a broad range of outcomes that could occur and just like all of you listening today, at some level, we're listening as well. We have to see where the judge ultimately ends up. 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, let's let's start with when the ODE for Bell Togo expires, right? That is in early twenty twenty seven. So we 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 two to five year old space on Liverman I I hate to give guidance on that, I think the court's 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. Thank you for that clarification. 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 in to 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 $66,000,000 number as opposed to the $47,000,000 number?

No problem.

Nice to talk to you. So one thing we got to remember, we do have for this year revenue from Libervant four, two to five in the guidance. Of course, as you just discussed about the court case, That is something that could impact the range of guidance as we move forward during the year. Now in addition [indiscernible] there is some level of erosion that we baked in as we usually do, whether there could be increased generic competition for Suboxone we're just unsure of.

Right now. So I think as the year progresses, and we see how the market firms up for Suboxone, and the orders we get from Adivir. That would impact our guidance as we move forward and we could we certainly would be tightening the range.

Thank you.

One moment for our next question. Our next question comes from Gary Nash with Raymond James. Your line is open.

Hi, great. Hey, guys and good morning.

So back to the AdCom, as you're preparing for it and you specific Can Dan, it sounds like you're now leaning much more to the likelihood that you'll have the adcom. So has there been any more guidance from FDA on that as you've been preparing the [indiscernible] or are you just being extra cautious? And then have some follow ups. Yes. Good morning, Gary. Yes, we have no additional insight 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 Anafilm 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 Anifilm on your own, how many reps will you need And then how quickly will you 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 he's been dying to jump in on the pediatric study. So thank you for that. 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 it's in NDA, we have that timing mapped out, so that there's no issue. But I'll let Carl give you his thoughts and what he's seeing.

Yes. No, 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 the requirement of submitting the filing as already stated, we will have the necessary data from the pediatric study 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 of 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. Nice to hear your voice. As you think about the number of allergists that are are practicing as well as some very kind of high desk out 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 phase in folks, but overall to cover the most important customers, think we're at a sweet spot of about 100. So that's first and foremost. As Dan mentioned, we will not we will 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 to hire the reps.

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 Anafilm 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 is probably a little different iterations there. But if you do sign someone in The U. S, and you decide to go down that path, what you think that might look like? And are you really leaning towards having a cocoa where you would also have commercial presence? Is that an important piece of it? Thanks.

Yes. Now for The U. S. In particular, we will not cover.

So we are we will not if we were to to partner with someone We will not partner with someone unless as I said in my prepared remarks, they have significant to help us and that they have a significant commitment to the therapeutic space.

So those are entry criteria for talking with us that we will not waiver from.

In terms of whether it ultimately we find a global partner or a U. S. Partner if we go down that path, I think there are large companies that fit both of the criteria. I laid out that could be both global or just U. S. So I think both of those are available. I do want to just remind everyone that ex U. S, we clearly in The U. S, it's more about what's the right path for getting Anifil into everyone Outside The U. S, we will be on a partnership only approach.

So, a little bit of a nuance between those two those two positions.

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 before there would be an adcom, if there is an adcom? Just because you are spending a lot behind all your prelaunch activities. So So you have to manage that with the possibility that you could have partner that would share in that So 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 in 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. We're 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 we will force ourselves or anyone else to.

Okay.

Got it. Thank you.

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

Hi, good morning. Thanks for taking the questions. Just a follow-up on a couple of questions that 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?

Almost immediately. So if you think about if we're in early you just assume early February, you have Cloud AI At the February, And so and the seasons starts to to ramp up. And so yes, we would look to do all the preparation work prior to the PDUFA and then hire the reps immediately thereafter.

Got it. And then, Dan, just to clarify, [indiscernible] product will there be? How many dosage forms will you actually have available for prescribing once the product is approved? Yes. So the initial approval will be for patients thirty kilos and up, which is about seven years of age. That will be comparable to the adult dose of the EpiPen.

The adult AMP 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 with the FDA and bring that to market. So at launch next spring, there'll be one dose.

Over time, as we take a view of the whole market, they'll ultimately be two doses. Got it. Appreciate it. Thank you.

Next question comes from James Millet with Alliance Global Partners. Your line is open.

Hey, guys. Thank you very much for taking the question. Ernie, just a quick one on the this may tie into the partnership portion that we just asked earlier. We've looked at the $16,000,000 G and A spend in the fourth quarter. Is that the level we should be looking at going forward? Is that dependent upon whether or not you're going to have a partner to Anafilm or is that number going to be going doubling going back to the 12 level through '25.

Well, one thing in the Jim, in the fourth quarter, there was a severance charge.

In there. So that inflated somewhat of the fourth quarter. But looking forward to 25, as I said in my prepared remarks, on our guidance we have included amounts for the pre commercial work for Anafil.

Some which Sherry has alluded to earlier in her comments, We are continuing to commercialize Libervant And so we would see some increase in our SG and A most likely in the second half of the year. Is where it'd be more heavily weighted. As we prepare for as we continue all the pre commercial work for Anafil.

Great. Thank you. And then last question for me then on the liver vent. Any risk in marketing LibriVent given with this ruling out there? I know it was touched upon, you don't really know going to happen with the courts. [indiscernible] any thoughts on timing and any risk you might have on still marketing Libervant? Given this recent ruling?

Yes. Look, the risk on marketing Libervant is completely the court system. So similar to my answer to Gary on timing of if we were to partner Anacel, it's similar with Libervant with the courts.

There are certain things we can control in this universe and the court system timing and the court system decisions is not one of those.

So, we will we're committed to patients in this space.

We think our product is important. We think it's important to patients. We'll continue to fight and advocate for them. And we'll see what happens.

Thanks for taking Aquestive. And 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 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 [indiscernible]