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On today's call, I'm joined by Dan Barber, Chief Executive Officer and Ernie Totes, Chief Financial Officer. Who are going to provide an overview of recent business development and performance for the first quarter of twenty twenty five followed by a Q and A session. The Q and A session, the team will be joined by Doctor. Carl Krause, Chief Medical Officer and Sherry Korchinski, 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 part of its review of first quarter twenty twenty five results. Description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday. Is posted on the Investors section of Aquestive's website. During the call, the company will make forward looking statements. We remind you of the company's Safe Harbor language as outlined in yesterday's earnings release. Well as the risks and uncertainties affecting the company as described in the Risk Factors section and other sections included in the company's quarterly report on Form 10 Q filed with the Securities and Exchange Commission on 05/12/2025.
10m 54s
As any pharmaceutical company, product candidates under development and product 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. 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 the cautionary statement. And the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward looking statements within 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, and good morning, everyone. We are now over a month into our FDA review for epinephrine sublingual film which if approved by the FDA will be the first and only oral medication indicated for the treatment of severe allergic reactions including anaphylaxis. As a reminder, we believe that in the years to come, the rescue medication market for severe allergic reactions will grow into a multi billion dollar opportunity.
12m 15s
We anticipate receiving our FDA acceptance letter next month with an FDA assigned action date in late January or early February. Of 2026. This is truly the most exciting time in the history of Aquestive. And we have officially entered the commercial prelaunch phase for Anafil. As the review clock ticks toward approval, we are shifting more and more of the company's attention towards ensuring a successful commercial launch in the first quarter of twenty twenty six if approved by the FDA. The first area of focus ensuring we have the right people with both significant experience in the allergy space and the right commercial experience to launch Anafel. I'm pleased to say we have the marketing team that built EpiPen to over a billion dollar brand And we have added colleagues with decades of market access and commercial launch experience.
13m 20s
I am thrilled by the team we have put in place. Our second area of focus is awareness of anaphylaxis and our clinical data among healthcare professionals. As we are in the pre launch phase, this work is conducted by our medical team through outreach to healthcare providers. We are very active in attending allergy conferences both national and local, where we present our posters and our publications. I'm proud to share that by the end of this year, we expect to have attended 25 conferences and published 16 posters and manuscripts. Bayer anticipated FDA action date we will have published almost 30 posters and manuscripts. Over the life of the ANIFILM development program. As a comparison, the sponsor of the recently approved nasal spray published approximately 20 posters and manuscripts before their approval. It is work like this that has me confident that we are well positioned to continue to increase our prelaunch awareness. The third area of focus is payer engagement.
14m 38s
As I mentioned in March, we now have in house market access expertise. And we are actively working with payers given the FDA rules that allow us to engage with payers in advance of anticipated approval. We will benefit from the distribution and payer contracts that were set up during our marketing of Libervant. These contracts remain in place and we will be able to utilize them for ANIFILM. Critically, these will save months and months of startup time and add to our launch efficiency.
15m 17s
Our positioning and advertising materials are well ahead of schedule for launch in early of twenty twenty six. We have been clear about our positioning for quite some time. Among patients and caregivers, we will focus on the ability to easily carry antifilm We believe ANNAFILM is the only product that if approved by the FDA allows for not just one, but two doses to easily fit on the back of your phone. Into a wallet or a small purse providing patients with an epinephrine product that can be with them anytime anywhere. This clearly resonates across the stakeholder spectrum and I am genuinely excited about the progress our marketing team has made. We remain very active on the advocacy front as well. We have significant engagement with all four of the national allergy advocacy groups We continue to sponsor several important patient programs with these groups, and more recently have become involved in shaping state level legislative actions geared towards ensuring patients have access to all pre measured forms of epinephrine. So from a commercial preparedness perspective, we have built a team of the right people developed a robust pre launch awareness platform, utilize our existing payer relationships to prepare for ANNAFILM, built our product messaging and advertising, and established significant relationships with the key advocacy groups.
16m 58s
This to me, positions us incredibly well for a fast start in twenty twenty six. Now let's dig a little deeper into exactly how patients will experience antifilm. Think about your phone for a minute. Think about the incredible power that you hold in your hand every single day. From your phone you can check the security at your house, start your car, track your heart rate, search the web for any piece of information on the planet And now thanks to Anifilm, and our farm film technology, it can act as your medicine cabinet. Now that's transformational. In fact, the mom of a teenage patient recently told us, and I quote, my kid never takes his current device with him. But while there are times they have no idea where he is, what he's doing, what he might be eating, I do know I see his epinephrine device, sitting at home on his bedroom dresser. Which puts me into complete stress mode The other thing I know is that without fail, he has his phone with him. How comforted I would be knowing that two doses of epinephrine were tucked into the back of his phone. In other words, he would never leave home without it.
18m 23s
End quote. It is realizations like this one that we believe drive caregivers and patients to show a two to one preference for Anafil over the existing medical devices. And that is also why with ANNAFILM, truly is believing. When we have the opportunity to show our technology physically, we find excitement, and growing interest in prescribing opportunities. In fact, almost 100% of healthcare providers we have surveyed and we've done a lot of surveys, believe their patients will be interested in antifilm. We also know that direct to consumer or DTC engagement is a significant element to awareness in this disease state. DTC efforts cost money and we will need to strengthen our balance sheet ahead of launch to use this part of our strategy effectively. While Ernie will give you more specifics on our financials, I'd like to share how I think about our cash position. First, we announced last night that we will deemphasize our AQST-one hundred eight studies during this launch period. While we are as committed as ever to 108, this frees up significant capital for commercial activities. Similarly, we were unhappy with the court outcome on Libervant, and we think this ultimately harms patients, this also allowed us to shift cash from supporting Libervant to the launch of Anafilm.
20m 4s
We will opportunistically look to strengthen our balance sheet through ex U. S. Out licensing of Anafilm and potentially refinancing our debt. These pathways could provide adequate runway for the support of ANIFILM not just through launch but through the first year of launch. And into 2027. We also continue to engage with potential sales and marketing partners in The US. However, as I've said before, the conditions have to be just right for this to be our path forward. Now let me turn to the FDA review of Anatone. We are pleased to say that we have already had engagement with the review division regarding our application. As of today, believe everything is on schedule for receipt of our seventy four day acceptance letter in mid June. We also believe our reviewers remain employed at the FDA though we do know that Sally Seymour, the division head for pulmonary allergy and critical care recently announced her retirement. We do not believe this has an impact on our application. We continue to prepare for an advisory committee meeting should the FDA require one. This work remains on schedule and we continue to believe we will be fully prepared for an AdCom well ahead of schedule should it occur.
21m 33s
Our regulatory team is also turning into focus to international markets, As I've mentioned before, we expect to engage with Canada, The United Kingdom, and the European Medicines Agency or EMA prior to approval of Anafilm in The US. These activities are in support of strengthening our balance sheet through finding a strategic ex U. S. Partner. Now let's turn to the macro environment for public life sciences companies. For most companies, the last few months have been very difficult. The long term prospect of tariffs and economic uncertainty has created volatility in many ways including revenue streams, supply chain, and long term outlook. In this environment, I am pleased to say we are well positioned We have examined our supply chain, and see minimal risk to price or supply volatility. Importantly, we also house our intellectual property here in The US. Simply put, we believe we are well positioned to weather the economic storm that has been impacting small businesses and the life sciences industry. Finally, I want to acknowledge and honor the previously announced recent passing of Doctor. Steven Wargaffi. Our Chief Science Officer. Steve and I worked together for over a decade and he was not only a brilliant scientist and a colleague, but also a friend.
23m 8s
He was a major contributor to the scientific advancement of ANNAFILM and we will honor his memory as we seek approval of ANNAFILM around the world. While we are fortunate to have his mentor, former chief technology officer and founding CEO, Mark Schogel, take over interim oversight of R and D Steve will be profoundly missed by all of us. So as we move forward, our focus over the coming months will be engagement with the FDA, on the review of our application engagement with ex US regulatory bodies on the NFL, strengthening our balance sheet through partnerships and potentially debt refinancing, maintaining our strong position in relation to tariffs and economic uncertainty, [indiscernible] more than anything else having laser light focus on our commercial launch of Anatol. With that, I will turn the call over to Ernie. Thank you, Dan, and good morning, everyone.
24m 12s
By now, you will 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 first quarter results in the Q and A. During the first quarter, we continued to execute on our strategy to support the continued development of the recently filed NDA for Anapil. Our lead product candidate that has no needle, is not a device, is orally administered and is easy to carry. This included strengthening our balance sheet with additional capital through our ATM facility and pre commercial launch activities for ANNOfil to increase awareness among physicians, payers, and the advocacy community. Aquestive's manufacturing business remains steady, with a gradual decline of Suboxone being partially offset by growth across newer collaborations including for the licensed products ONVIF, SYMPAZAN, and EMILIF. Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations.
25m 32s
In addition, being a US based manufacturer with intellectual property domiciled in The U. S. Our supply chain currently remains largely unaffected by both implemented and proposed tariffs, providing continued reliability and stability in production, and global distribution for the near term. Now let's turn to the first quarter results. Total revenues decreased to $8,700,000 in the first quarter of twenty twenty five $12,100,000 in the first quarter twenty twenty four. This 28% decrease in revenue was primarily driven by decreases in manufacturer and supply revenue and license and royalty revenue, partially offset by increases in proprietary product revenue net. Manufacturer and supply revenue decreased to $7,200,000 in the first quarter twenty twenty five from $10,500,000 in the first quarter twenty twenty four primarily due to decreases in Suboxone revenues partially offset by an increase in ONDIF revenues. License and royalty revenue decreased 30% or $300,000 in the first quarter twenty twenty five compared to the same period in the prior year. This decrease was primarily due to lower as TARs royalty revenues lower with the termination of a licensing and supply agreement in the prior year. Co development and research fees in the first quarter of twenty twenty five remain relatively unchanged compared to the same period in the prior year.
27m 18s
Research and development expenses decreased to $5,400,000 in the first quarter of twenty twenty five from $5,900,000 in the first quarter of twenty twenty four.
27m 30s
The decrease in research and development expenses was primarily due to lower clinical trial costs associated with the continued advancement of the antifilm development program, partially offset by increases in product research and preclinical expenses higher personnel costs and higher share based compensation. Selling, general and administrative expenses increased to $19,100,000 in the first quarter of twenty twenty five from $10,700,000 in the first quarter twenty twenty four, primarily due to regulatory fees of $4,800,000 including the antifilm PDUFA fee, higher legal fees of $2,300,000 higher commercial spending of approximately $2,100,000 higher personnel costs of approximately $400,000 higher share based compensation expense of $300,000 partially offset by decreases in severance costs of approximately $1,100,000 and lower insurance expenses of $200,000 Aquestive's net loss for the first quarter of twenty twenty five was $22,900,000 or $0.24 for both basic and diluted loss per share. Compared to the net loss for the first quarter twenty twenty four of $12,800,000 or $0.17 for both basic and diluted loss per share. The increase in net loss was primarily driven by the previously discussed changes partially offset by increases in interest income, and other income. Non GAAP adjusted EBITDA loss was $17,600,000 in the first quarter of twenty twenty five compared to non GAAP adjusted EBITDA loss of $7,200,000 in the first quarter of twenty twenty four.
29m 30s
Cash and cash equivalents $68,700,000 as of 03/31/2025.
29m 38s
Aquestive has revised its full year 2025 financial guidance as a result of the change in regulatory status of Libervant and pausing sales and marketing activities for the product. The company now expects total revenue of $44,000,000 to $50,000,000 and non GAAP adjusted EBITDA loss of $47,000,000 to $51,000,000 Our revenue guidance for 2025 no longer includes revenue for Libervant for ages between two and five years. As a reminder, our 2024 revenue included one time non recurring recognition of [indiscernible] 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 ANNOfilm costs associated with the recent submission of the ANNOfilm NDA and related filing fee Completion of the ANNOfilm pediatric clinical trial and preparations for a potential advisory committee meeting if required by the FDA, for approval of Anafilm.
30m 52s
With that, I will now turn the line back to the operator to open the line for questions.
31m 15s
Our first question comes from Roanna Ruiz with Leerink Partners. Your line is open.
31m 21s
Hey. Good morning, everyone. So a couple from me. Was curious if you could update us on where you are in your commercial readiness efforts including CMC, manufacturing scale up, etcetera for ANNAFILM. And I also wanted to see if you refined your goals for hiring a field force for antifilm and including how many physicians would they target out of the gate [indiscernible] So, I'll take this is Dan, I'll take the first part of your question, then I'll hand it over to Sherri. To talk about the sales force and how she thinks about it.
32m
One of the highlights or things that we're proud of and think is a strength for our company, is the fact that we have the manufacturing in house. So as you know, CMC manufacturing scale up that is all well within our capabilities, and something we've done several times [indiscernible] without issue. So we believe we're very well prepared on that side, We'll have product ready to go day one. And those plans are in place and being worked on. So I'll pass it over to Sherri to talk about the sales force. Hi Roana, nice to hear your voice this morning. I have to say I'm so excited to be chatting with everybody this morning, as we are very focused on a on a successful launch. As you know, built the team that built EpiPen to over $1,000,000,000 And as I reflect upon that build, one of the things that I've been looking very closely at is the number of salespeople. And so, we will probably start at around 50 sales representatives and focus on the top epinephrine prescribers, as I'm sure you can imagine. That will include about 4,000 or 5,000 of the top allergists and pediatricians, as well as the NPPA staff that really support the physicians and the allergists in the office.
33m 30s
And so that's where where we are right now. We're in the process of conducting segmentation and ensuring our marketing mix model works very smart for us.
33m 46s
Very helpful. And one follow-up for me. I was thinking ahead to the ANNOfilm launch, could you explain a bit more about your key goals in interacting with payers to set up broader favorable access for antifilm, and do you have any idea of the timelines it would take to set up this access and the best case of favorable coverage ranophone for a majority of patients.
34m 9s
Right, well I'll let Sherry give you her her thoughts in a second here, but I just want to reiterate as you just heard in my comments before, with the work we did on Libervant, one of the great benefits is the contracts that we now have in place, both from a distribution and a payer perspective. So those remain open.
34m 31s
And we will definitely be able to leverage those as we go into this launch period. But Sherri can talk more about her specific thoughts on her goals.
34m 38s
Sure. As Dan mentioned, we have hired VP of Market Access and we took our time to make sure we hired the right person. And so we brought on someone who has experience in in small pharma and very large pharma. Who knows the payers personally, and has extensive experience in launching products. And so we're very excited about her and the team that she is bringing on. As Dan mentioned, we have been working with the payers, both on Libervant and messaging around Anafilm, given the guidance that permits us to do that. And so when we think about the access, as you know, we will be entering a period now of furthering those conversations, and upon approval [indiscernible] be ready to have our contracting strategy implemented. Now if you take a look and you can just use our competitor as an example, there is timing associated. The payers do require rather significant amount of time, several months, before they will consider adding to formulary. So I would think about it as kind of the first six months of launch we will be ensuring that we have upwards of 80% coverage by the end of that six months. With Toronto, we would take us right into the back to school season.
36m 18s
So I feel very confident in the team I have to implement and drive that success from a market access perspective. Sounds good. Thanks a lot. One moment for our next question. Our next question comes from David Amsellem with Piper Sandler. Your line is open.
36m 43s
Thanks. So a couple for me. First, can you talk to any learnings that you've gleaned from the launch of Nefi I know it's fairly early days, but maybe you can talk to the extent to which that product is expanding the market, and what you think that could mean for ANNAFILM. So that's number one. And then number two is on the potential for an AdCom Maybe give us a reminder of that how you're thinking about that. In other words, what do you think are sort of the key salient topics that would come up in an AdCom to the extent there is one. Thank you. Sure, David. So I'll hand it over to Sherri to second here again. To give you her thoughts on what she's obviously her and her team are on a daily basis watching the market, but I will say to you, we do see the expansion in the market occurring that we would expect in Q1 of this year volumes were up 5% over last year, and we do expect, as you've heard me say many times, this market to to at least double over the years to come. So I'll let Sherry give you her thoughts, and then I'll address the outcome.
38m 8s
For you as well.
38m 8s
Hi David, great question. Again, go back to my EpiPen days, Whenever I took over that brand, we were at about 150,000,000 to $200,000,000 in sales. I think one of the things that we learned very quickly is the absolute critical nature of market expansion. And we were able, through market expansion efforts, disease state awareness, patient engagement, and calling on the 25% back in kind of the mid-twenty ten, 'eleven, 'twelve mark. And so look, at the end of the day, NEPI is doing the same.
38m 54s
It's Dan mentioned. The more messaging that's out there, the better for all of us. And so I think that they're doing absolutely the right thing. They went out to the physicians first, as they're gaining payer access to drive demand. And now you're seeing more patient engagement social media marketing, and they've announced publicly that they're launching a big DTC campaign. Again, that is fantastic. What is the saying arising? Tide rises all boats, and I think it will benefit all of us.
39m 34s
Thanks Sherri. I'll hand it over to Carl in a second. His thoughts on the AdCom. What I would say in terms of the topics, the specific topics, obviously we don't know. But I would just remind you we've had extensive interaction with the FDA, we've been very transparent about the discussions we've had with the FDA, so I think the issues for topics that we would expect at the AdCom, I think, are pretty well documented. But Carl can give his thoughts on how we're preparing and where we are at work. Yeah, thanks Dan, and David thank you for the question. It's an important question, and I would just state that this is probably the most robust data set conducted to date for an epinephrine product, we've had over nine thirty or so dosings, probably 800 plus singles. And 125 repeat doses. It's it's a comprehensive NDA that was submitted Difficult to know what the FDA may request of us, but we are fully prepared to respond to whatever those questions may be. We are in the midst of aggressively preparing for anything that they may want further information on. I would say that this is the first oral epinephrine product, so depending on how they get excited by that and what kind of questions they may have, we'll be happy to respond in due course.
40m 54s
Okay, I'll leave it there. Thank you.
40m 57s
One moment for our next question. Our next question comes from Kristen Kluska with Cantor Fitzgerald. Your line is open.
41m 7s
Hi, good morning everybody. Wanted to ask how you envision a new division head for this pulmonology allergy space could potentially influence both an AdCom and the review process and outside of Doctor Seymour of the people you've been engaging, even before you filed as you currently filed, would you say that there are other changes as well?
41m 34s
Sure. Good morning, Kristen.
41m 36s
So, we in our interactions have not dealt with the division. We have had the deputy division head as the person who oversaw the interactions. And as of today, obviously the FDA is in evolving organization in today's environment, but as of today, the review team and the deputy director all remain the same, for our program, and those were also the same people for the program that came before us. So, from a review process standpoint, all the interactions we've had so far suggest that things are in a normal state, which is positive, we believe, In terms of the AdCom, as we've stated before, the best I can tell you is we are ready. We want to have an AdCom, we are ready we hope it happens, I do have some doubts I will tell you on whether the government is in a position to to make things happen for an AdCom, but we will be ready and we hope it does happen.
42m 41s
Thank you so much.
42m 44s
Moment for our next question. Our next question comes from Jason Butler with Citizens JMP. Your line is open.
42m 54s
Hi, thanks for taking the questions. Two for me. First of all, can you just talk about where you think awareness of ANNAFILM with with providers is today and how you're measuring or assessing how awareness is building throughout the year or heading into the launch? And then secondly, I'm just wondering if think about the seasonality of the market as well as the time taken to get payer access, how should we think about the adoption curve in the first few months of the launch? Thank you.
43m 25s
Sure.
43m 27s
So I'll pass it over to Sherri for both of those items.
43m 32s
Good morning Jason. You know, as we think about ANNOfilm and knowing that we certainly have created a transformational epinephrine for patients and their caregivers. As the only non device oral epinephrine physicians are very, very excited about product. So we've done upwards of 1,000 interviews with patients and HCPs alike, there continues to be incredible excitement. As Dan mentioned, we are, from a medical perspective, engaging heavily with KOLs and gives the allergy community. So I believe our awareness is growing We did conduct a baseline ATU trial at the December, and so we are measuring how that awareness continues to grow. But that is where all of our focus is right now, as again, Dan and Carl's team have really been engaged in being at a variety of not only the big conferences, the big allergy conferences, but also state and regional conferences [indiscernible] share the exciting brand that we have for patients suffering from severe allergic reactions. So I feel really good about the awareness and how it is growing to prepare us for a fantastic launch [indiscernible] early Q1 of 'twenty six. As it relates to your second question, how do we think about seasonality? This market is pretty tried and true.
45m 20s
Start to see the pickup in the April timeframe. It really peaks again August and September in that back to school timeframe. And so as we've mentioned previously, we are engaging with the payers now, as soon as there is approval we will work to have the contracting complete as quickly as possible. I do think that you can book to the NEFI curve to a certain degree to say, it will probably follow this similar uptake. The payers take their time Some have blocks for the first handful of months, but we will have other ways for patients to access the medication. Now with that being said, I do feel super confident by that back to school season, we will have the majority of the market covered for our access. And that would be the most important time, so that August September, October timeframe. Does that answer your question?
46m 28s
That's great. Thank you very much.
46m 31s
One moment for our next question. Our next question comes from Ram Selvaraju with H. C. Wainwright. Your line is open.
46m 43s
Thanks very much for taking my question. Firstly, on anofilm, I wanted to ask if you could comment on your thoughts regarding direct to consumer advertising strategies that would most appropriate to support this product, what those might look like, specifically how they might be similar to, analogous to, or differ from the DTC advertising that's been used in support of NEFI so far.
47m 9s
And also, if you could give us a sense of when in the launch trajectory, you consider it most appropriate to deploy such strategies. Thank you.
47m 20s
Right, good morning, Rob. I'll hand it over to Sherry in a second to talk about when we would deploy, but let me give you some just general thoughts on DTC awareness. I think especially in a space like this, DTC is important for awareness. It is a great way to drive awareness around the disease state, and to drive people to their physician to ask about what they should be doing. If you listened and watched a lot of DTC advertising, oftentimes the product isn't as prominently focused in that DTC as it is the awareness of the disease. So we actually believe and I'll borrow from Sherri's statement before, we firmly believe that a rising tide raises all boats in this particular market. This is a very large market, it's an expanding market, and we believe that the DTC efforts of anyone in this market helps the overall group. So in terms of our positioning, look, if you take away anything from today's call, it should be that we are focused. And we're focused on making sure that we are in the physician's offices where we can win, where we can make sure our scripts start to flow.
48m 37s
That will be the number one priority. DTC well I don't want to steal Sherry's thunder, so I'll let her talk about where we would layer in Yeah, it's a great question, Ram. So again, when you think about a launch, first and foremost, physicians have to be aware of the product. And so the focus is typically heavy physicians, for the first several months. While you're also in parallel beginning the DTC effort. So social media, digital advertising, working very hard with the patient advocacy groups. That can make patients aware. If you think about kind of as I'm thinking, I should say, of the launch of ANNAFILM, I'm thinking of it in three buckets. One is awareness, the second is preparedness, and the third is access. So awareness is critical. Awareness of the HCP is critical. A physician has to be aware of the product, know how to write the product, know what to expect. And so again, that's what you've seen with our competitor. That's what you see really with most pharma brands that are very DTC focused. While that is happening, patients are also being made aware through, again, social media, digital advertising, print advertising, and now radio advertising.
50m 6s
Advertising has come back on the market. And so patients are becoming aware. So you have an intersection where the patients, are in the offices, they are speaking with the physicians, you have the sales reps out there, we're working to make more and more physicians aware of the product, and so you have this intersection where a physician is ready to prescribe, and the patient is ready to receive. So again, first and foremost is that HCP promotion, You start to layer in more and more DTC promotion, as your coverage, your market access coverage increases. And so you would expect that and just like you're seeing with our competitor, they'll be out eight months, they're starting to talk about their heavy DTC campaign. That's how [indiscernible] big brands think of direct to consumer, and that's based on my experience as well.
51m 6s
Thank you. Then just following on from that, I was wondering if you could just describe for us the distribution infrastructure and the channel that's likely to be used in support of ANNAFILM as and when the product gets approved for The US? And also, if you could talk a little bit, particularly in the context of the most favored nation pricing construct, how you are thinking about optimizing the opportunity for ANNAFILM outside The United States and what you currently consider to be the highest value territories for the product ex US.
51m 42s
Sure, Rob. Let me go in almost reverse order, so I'll leave Sherri the distribution infrastructure in The U. S, but let me address the most favored nation comment you made, which I think is in reference to the executive order that we saw come out yesterday from the White House. From our perspective, for companies like us, who are up and coming, are agile, are looking to be disruptive and different, there's nothing but opportunity. In some of the different ways that things seem to be evolving, as you saw in that executive order, there was actually a mention of finding ways to cut out the middleman. We would love that. I don't know if it's completely practical in today's world, but those are things that we as a smaller, flexible company love, and would like to take advantage of as time goes on. In terms of outside The US, and Ram, as you know, that's really just data, that data's public. The biggest markets to focus on are Canada, The UK, and Germany. So that's why we've said that our international interactions this year with regulatory bodies will be Canada, The UK, and EMA. So we've lined those up with where we see the value ex US.
53m 4s
With that, I'll let Sherri take on the distribution. Sure.
53m 8s
And as you know, antifilm is absolutely transformation. We'll be upon approval, transformational for patients and caregivers alike. What we do know is this is still predominantly a retail driven product. And at the corner of health and happiness, distribution through the retail channel. However, our market access lead, who we brought on specifically based on her experience looking at and using alternate distribution channels and models. And so we are assessing the different ways in which a customer, a patient, or a caregiver can access access Anafil. And so yes, you would expect it to be in your local CVS and Walgreens, but you can also expect to see other ways in which a patient will be able to access Thank you.
54m 6s
One moment for our next question. Our next question comes from Gary with Raymond James. Your line is open.
54m 17s
Hey, guys. Good morning. This is Dennis Resnick on for Gary Nachman. Thanks taking our questions. So first, for Anafilm x US, if you're looking for partner there, would you want them to do the regulatory submissions in those international markets or would that be something that you would take on your own? And then is the next US partnership something that we can hear about this year? And then when we think about The US, commercialization launch, can you just talk a little bit more about what your ideal early adopter prescriber of Anafilm looks like And I've got one follow-up.
54m 49s
Thanks Dennis. So, I'll let Sherri in a minute talk about how she thinks about HCP in patients and the ideal adopters. In terms of the ex US regulatory submission strategy, that is definitely partner dependent, but I would say this, we have an excellent regulatory team that does a phenomenal job, not just here in The US, but our interactions around the world. As you know from our previous engagements and partnerships we have extensive experience ex US, and so the engagement with regulatory bodies, and even submitting Pax US is not an issue for us to support [indiscernible] again, that would be more partner based on what the right setup would be. In terms of timing, Dennis, I learned long ago in this this role, that timing is a dangerous thing when it comes to partnerships. What I would tell you is that we are very active on engaging on that front, and that as we learn more and as we understand how that will evolve, we'll communicate as we can. With that, I'll let Sherry take on adopters.
56m 5s
Good morning, Dennis. Thanks for the question. It's a great question. As we have done more than 1,000 interviews with HCPs and patients, even most recently, what we continue to hear to is that there is still an enormous unmet need for a non device that is discreet convenient, easy to carry, and easy to use. And so while there are more choices now, there is still a tremendous unmet need. As Dan mentioned in his earlier comments, it is not atypical for us to have parents teenagers, and physicians come up to us at the conferences and say, Oh my gosh, absolutely carry this. I can put it on the back of my phone. It's like an extension of myself. And so it fits Anafilm will fit into patients' lifestyle. I believe better than any product. That is currently on the market. And so as we think about who our early adopters will be, what we're thinking is that first of all, it's the physicians that are seeing the majority of patients. It's the physicians that are hearing from their patients or their patients' mothers, that my kid still doesn't carry, my kid doesn't want a device, And so we believe that the adoption will be in early prescribers our competitor, as well as then those physicians who continue to hear [indiscernible] patients want an oral medication.
57m 42s
And I'll just leave you with this. In some of our market research that we did with physicians, ninety five percent of physicians believe that a film dosing option fills an unmet need in the epinephrine market. Nine point five out of ten physicians That's a lot of doctors. And eighty five percent have told us that they will prescribe a film dosing option, and they expect their prescriptions to increase. And so while I love to boil the ocean and [indiscernible] be able to impact tens of thousands of physicians we are going to have a very targeted, very focused approach to call on the the highest decile prescription in order to drive that early adoption and that early revenue stream. Does that answer your question?
58m 39s
Yes, that is super helpful. Thanks so much. And then just one quick follow-up on the top line pediatric data that you had previously presented. When we look at the geometric mean adjusted epinephrine concentration between the pediatric and adults, Can you just provide a little bit more color as to why the pediatric patients perhaps saw an increase earlier than the adults? And then why they didn't reach the same high concentration. Thanks for all the color guys.
59m 4s
Yeah, I'm going to pass it over to Carl But just to reiterate, our view on the pediatric data, we think that pediatric data is exactly in line with expectations and is supportive of the the product having a label down to 30 kilos and up, but I'll let Carl give you some more specific thoughts Yeah, no, appreciate the question. I would just remark that the data that we've evaluated is completely in line with what we had expected and hoped for based on the known characteristics of the adult dosing. And statistically there is no difference that we found to be of an clinical significance. So I I appreciate the observation, but when you look at the data in detail, it's completely in line with our hopes and our expectations. We very excited by this data. [indiscernible] so much, guys.
1h 2s
One moment for our next question. Our next question comes from Nelson Cox with Lake Street Capital Markets. Your line is open.
1h 13s
Great.
1h 13s
Thanks for taking questions. Nelson on for Thomas. First one, just wondering maybe quickly if you can talk about the cash you believe you'll need for the launch of ANNAFILM Just any commentary there, think, would be helpful.
1h 26s
Sure. Well, I'll pass it over to Ernie in a second.
1h 29s
But let me just frame cash, because that's a really important piece for launch, right? First, I would remind everyone especially as this company has evolved over the last few years, we have something of incredible value. And we are focused on making sure that we maximize that value for our shareholders. So we're actually very excited about where we are, especially from where we've come from, We think we have a lot of optionality that we did not have when I look back several years ago. But I'll let Ernie give you a little bit more specifics around that. Sure Nelson. So our we have, as Dan said, something very valuable. And with that we have a number of paths to help finance the launch. And just to reiterate, we have said we are not hiring one sales rep until we have approval. We will do all the preparatory work, we'll do all the pre commercial work this year, but we will not spend money on sales reps until we have approval and then will ramp up to be prepared to sell as soon as possible. Our cash provides us runway in, through this year, and the initial stages of that launch next year.
1h 1m 53s
But we have a number of levers to pull on how rapidly we spend our cash. And also, as the the previously mentioned opportunities to partner ANNOFILM outside The US. Refinancing our debt, all these non dilutive ways to help fund the launch. So we feel we're in a good position to be prepared for next year.
1h 2m 22s
Perfect, that's helpful, thanks. And then maybe just a two parter quick. Will you recognize any Libervant revenue in the second quarter? I know it would probably be minimal, but any commentary there? And then when is the earliest you might know about a advisory committee meeting?
1h 2m 40s
The revenue for Libervant in the sec quarter is minimal. And just to reiterate what I said in my comments, our guidance for this year [indiscernible] revised guidance, we've essentially taken out Libervant completely for the rest of the year, The revenue we reported even for the first quarter is not significant, even though we were making great progress on ramping up Libervant, but it is not we're not reporting significant amount of revenue for this year, for Libervant. But importantly, we are taking out expenses, that will add incrementally to our cash for the rest of the year. And Carl, you want to take your thoughts on when we would know when an ad Sure, so the FDA, the division in particular, clearly has liberty to to alert us at any time but we are certainly hopeful they would do so by day 74, but it's obviously at their discretion.
1h 3m 46s
Great, thanks for taking the questions guys.
1h 3m 49s
One moment for our next question. Our next question comes from James Malloy with Alliance Global Partners. Your line is open. Hi, guys. Matt Venezia on for Jim. Thanks for taking the questions.
1h 4m 7s
So about the potential partnership ex U. S. Distribution of Addatum, how would you characterize the partnership environment currently? And in terms of AQST-one hundred eight, when would you anticipate the potentially reprioritizing that clinical development Should we look at it in sometime 2027 post launch of Anafilm? Thanks.
1h 4m 30s
Thanks, Matt. Let me go and reverse order. I just wanna reiterate and I made this comment earlier, but I want to make sure I make it clearly, I believe one and eight is a great product. I believe it is a big opportunity for the company there. I think the science is very interesting. And it's science that we can deliver and can be transformative in another area So in no way are we backing away from how much we like 108. But there's millions of dollars we were going spend on 108 this year that are better off in hands of Sherri and our antifil launch. So my goal, my desire, is to get back to prioritizing 108 as soon as possible. But we will not do that in any way that sacrifices any ability to launch antifilms the best way we can. In terms of the partnership, environment outside The US, I would say it's active. You obviously saw our competitor have a deal in Europe with another company. There are other companies that are interested in being in that market, and we're in discussions with the right people so we'll continue to push that along and we'll tell you more as we know more.
1h 5m 49s
Great, okay, thank you guys for taking the questions.
1h 5m 53s
And I'm not showing any further questions at this time. I'd like to turn the call back over to Dan for any closing remarks.
1h 5m 59s
Thanks, Kevin, and hopefully theme you heard from us today came through loud and clear, which is we are focused on the launch of Anafilm. And that's the right place to be for this company at this time, with a filing in at the FDA and the launch clock ticking down. We appreciate you joining us this morning, and I look forward to updating you everyone, as we progress through our antifilm FDA review period and as Sherri and her team continue to prepare for launch. With that, I wish all of you a great rest of your day.
1h 6m 33s
Thank you, ladies and gentlemen. This does conclude today's presentation. You may now disconnect and have a wonderful day.
Key Insights
Aquestive is preparing for the potential FDA approval and commercial launch of ANNAFILM, an oral epinephrine product for severe allergic reactions, with an anticipated FDA action date in late January or early February 2026 and a targeted launch in Q1 2026.
The company is focusing on commercial readiness, including building a specialized marketing team (with EpiPen experience), increasing awareness among healthcare professionals, leveraging existing payer contracts, and engaging with advocacy groups; initial sales force is expected to be around 50 reps targeting top prescribers.
Q1 2025 financials showed total revenue of $8.7M (down 28% YoY), a net loss of $22.9M ($0.24/share), and a non-GAAP adjusted EBITDA loss of $17.6M; cash and cash equivalents were $68.7M as of March 31, 2025.
Full-year 2025 guidance was revised to total revenue of $44M–$50M and non-GAAP adjusted EBITDA loss of $47M–$51M, reflecting the pause in Libervant sales/marketing and increased pre-commercial spending for ANNAFILM.
Aquestive is exploring ex-US partnerships for ANNAFILM (targeting Canada, UK, and Germany), may pursue debt refinancing, and will not hire sales reps until FDA approval; the company believes it has sufficient cash runway through launch preparations and into 2026, with additional funding options available.
