Aquestive Therapeutics Q1 2026 Earnings Call Transcript

Quartr
Provided by Quartr
May 14, 2026

Key Takeaways

  • Positive Sentiment: Aquestive said it remains on track for a Q3 resubmission of Anaphylm to the FDA, with human factors and PK data expected in time for the August earnings call if the FDA returns feedback on schedule.
  • Positive Sentiment: The company completed a $150 million Oaktree debt facility, which lowers interest costs, delays principal payments for years, and helped secure liquidity; management said this puts it in a strong cash position for a potential Anaphylm launch.
  • Positive Sentiment: Management highlighted encouraging ex-U.S. regulatory progress, including confirmation from the U.K. MHRA that no additional studies are needed before filing and a pediatric plan submission to the EMA, supporting filings in the U.K., EU, and Canada without more clinical work.
  • Neutral Sentiment: First-quarter revenue rose to $14.4 million from $8.7 million a year ago, driven by higher license/royalty revenue from Zevra and stronger manufacturing and supply revenue, while net loss narrowed to $8.1 million.
  • Positive Sentiment: Early AQST-108 phase 1 data showed no drug-related adverse events and no meaningful systemic absorption, while a directional biomarker signal in TSLP suggested potential broader dermatology applications, including alopecia and atopic dermatitis.
AI Generated. May Contain Errors.
Earnings Conference Call
Aquestive Therapeutics Q1 2026
00:00 / 00:00

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Operator

Good day, and thank you for standing by. Welcome to the first quarter 2026 Aquestive Therapeutics earnings conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, we'll open up for questions. Please be advised that today's call is being recorded. I would like to hand it over to our first speaker, Faith Pomeroy-Ward. Please go ahead.

Faith Pomeroy-Ward
Faith Pomeroy-Ward
Corporate Communications and Investor Relations Strategist at Aquestive Therapeutics

Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the first quarter ended March 31st, 2026, and a progress update on the company's key 2026 objectives, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Matt Greenhawt, Chief Medical Officer, Melina Cioffi, Senior Vice President, Regulatory Affairs, Sherry Korczynski, Chief Commercial Officer, and Dr. Matthew Davis, Chief Development Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call and related supplemental materials will be made available on Aquestive's website within the investors section shortly following the conclusion of this call.

Faith Pomeroy-Ward
Faith Pomeroy-Ward
Corporate Communications and Investor Relations Strategist at Aquestive Therapeutics

To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2026 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the investors section of Aquestive's website. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in today's earnings release, as well as the risks and uncertainties affecting the company as described in the Risk Factors section and in other sections included in the company's annual report on Form 10-K, filed with the U.S. Securities and Exchange Commission on March 4, 2026.

Faith Pomeroy-Ward
Faith Pomeroy-Ward
Corporate Communications and Investor Relations Strategist at Aquestive Therapeutics

As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. Now, I would like to turn the call over to Dan.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Good morning, and thank you for joining us today. In the last 62 days since our earnings call, we have progressed the company significantly. For Anaphylm dibutepinephrine sublingual film, we have completed our Type A face-to-face meeting with the FDA, completed a teleconference with the U.K. regulatory body known as MHRA, submitted our pediatric investigational plan to the European Medicines Agency, and submitted our human factors protocol for review by the FDA. In addition, we have closed on a new debt facility with a leading life sciences debt provider and completed our phase I safety study in humans for our pipeline program, AQST-108. We are also on track to attend over 40 conferences and submit over 20 publications this year. It is a testament to the Aquestive team that they were able to complete so much important work in such a brief period of time.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

The question, of course, is where does this work take us, and how do we expect the coming months to unfold? Today, I am providing guidance that we currently expect to have our human factors data and potentially our pharmacokinetic data for Anaphylm available in time for our August earnings call. The completion of this data is dependent on the FDA providing responses to our human factors protocol on time and the responses being within expectations, including with respect to the scope and content of that feedback. With these assumptions in mind, we continue to guide to a third quarter resubmission to the FDA, recognizing this timing remains subject to FDA feedback and ongoing review processes. As we've stated in the past, we currently expect our resubmission of the NDA for Anaphylm to be classified as a Type 2 submission with a six-month review.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Although final classification is determined by the FDA. We will request an expedited review upon our submission, and we'll do everything we can to communicate with the FDA and support their review process, recognizing that any decision on review timing rests solely with the FDA. We believe the comments by FDA's leadership on the need for the agency to provide more timely feedback and review points to a broader agency focus, and in this case, may create the possibility of aligning with the FDA on a faster process. This, of course, cannot be guaranteed. Our commercial preparations continue to progress. Importantly, we were pleased to enter into a $150 million debt facility with Oaktree, a leading life sciences debt provider. While Ernie will talk about this in more detail, at a global level, this agreement unlocks several important things for Aquestive.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

One, we have improved the interest rate terms on our existing debt, and principal payments will not begin for several years. Two, this completes the pre-approval requirements for the RTW funding. Three, we have the ability to access $20 million in additional capital if Anaphylm is approved by the FDA. Taken together with our existing cash and the RTW deal, we currently project that we will have greater than $150 million in cash at launch, and this is before considering ex-U.S. Anaphylm and U.S. Libervant out-licensing deals. We plan on using this cash to focus on building intense awareness and access within the allergy community for Anaphylm. We have already shared our plans for launch of Anaphylm with you, if approved by the FDA, including a strong medical affairs presence, a 75-person sales force, and a focused marketing effort.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

We have also been watching and learning from the launch of a nasal spray product in the market. Our research within the allergy community indicate that building clarity, trust, and support for allergists is key to unlocking prescriptions. This may seem obvious, but just think of the daily pressures allergists face in running their practices. Fitting into their world in a meaningful and credible way in furtherance of patient access to Anaphylm is task number one, two, and three for us. While the U.S. market is incredibly important to us, we can't forget that 96% of the world's population does not live in the U.S. I truly believe Anaphylm is a product that will save lives, and we want as many people as possible on this planet to ultimately have access to it. Our lead ex-U.S. strategy continues to be Canada and Europe, and we've made significant progress.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

As I mentioned before, we recently completed a comprehensive and positive interaction with MHRA, the U.K.'s regulatory body. I'm pleased to say we received confirmation that we do not need to conduct additional studies before submitting our application to MHRA in the U.K. We also recently submitted our pediatric investigational plan to the European Medicines Agency, or EMA, for the European Union. Aligning with EMA on this plan is essential to submitting our application. We now know that we can submit applications in the EU, U.K., and Canada without conducting further clinical studies. Between the U.S., Canada, the U.K., and the European Union, our product, if approved in each of these regions, could eventually be available to almost 1 billion people in the next several years. Let's talk about our product pipeline.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Given the excitement around Anaphylm, people often forget that we are utilizing our epinephrine prodrug platform, AdrenaVerse, to advance treatment in other indications. Our lead asset is AQST-108. We recently completed a phase I safety study in men with androgenic areata. I am pleased to say that there were no drug-related adverse events observed in the study, and we also saw no appreciable signs of systemic absorption of our epinephrine prodrug or of epinephrine itself. We did, however, see something intriguing. Keep in mind this is very early phase I study data. Our Chief Development Officer, Dr. Matthew Davis, added biomarker assays to the study to see if we could detect changes in key proteins associated with both alopecia areata and androgenic areata, along with other dermatological conditions such as atopic dermatitis.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

While this information is not statistically powered and should be viewed as directional only, we were pleased to see in subjects with alopecia that the cytokine TSLP appeared to be impacted by AQST-108. This was not the case when subjects were given placebo. This is very exciting as the signaling pathway for TSLP involves the activation of JAK1 and of JAK2. We have included preliminary data on this work in our supplemental material available under the presentations section of the investor page on our website. We will talk more about the next studies for AQST-108 in the coming months once we have resubmitted our Anaphylm application in the U.S. Our business development efforts and base business continue to move forward. Our business development team is currently in active negotiations on multiple programs for Europe, the U.S., and South America.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

We have also had outreach from additional regions of the world, including China and Australia. We are prioritizing this work based on the territory and program involved. We expect to have more to say on this topic in the months to come. In summary, we expect to provide a significant data update in August, assuming the FDA keeps to its review timeline and provides constructive comments to our human factors study protocol. We continue to drive awareness in the epilepsy community ahead of a potential product launch of Anaphylm, if approved by the FDA. Our international filing efforts continue to be a priority and our AQST-108 program continues to show promise for expansion into potential multiple indications. With that, I will turn the call over to Ernie.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Thank you, Dan, and good morning, everyone. By now, you will have seen our first quarter 2026 financial results in the earnings release issued last evening and detailed in our Form 10-Q filing. As we typically do, we will address most of the detailed discussion regarding the quarter during Q&A, and I will focus my remarks on financial performance, operating spend, and liquidity. During the first quarter, our primary financial focus remained supporting progress on Anaphylm following receipt of the FDA complete response letter on January 30th, 2026, while maintaining a strong balance sheet and financial flexibility. Subsequent to quarter end, we completed a Type A meeting with the FDA and aligned on the remaining requirements for approval, including a human factors validation study and a PK study, both of which are currently underway.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

During the quarter, we extended our strategic funding agreement with RTW Investments through June 30, 2027, further strengthening our liquidity runway and financial flexibility as we work towards Anaphylm resubmission. We announced the refinancing of our existing debt with a new $150 million debt facility with certain funds and accounts managed by Oaktree Capital Management. This transaction reduces our interest rate, extends the interest-only period, saving $45 million in principal payments over the next three years on the existing debt that were scheduled to commence on June 30th, and provides additional flexibility to fund the launch of Anaphylm if approved by the FDA.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

The new debt facility is available in four tranches, with Tranche A of $55 million refinancing the existing debt, Tranche B of $20 million available upon FDA approval of Anaphylm, Tranche C of $25 million available upon achieving certain sales levels, and Tranche D of $50 million available upon mutual consent of Oaktree and the company. Let me walk you through our first quarter results. Total revenues increased to $14.4 million in the first quarter of 2026 from $8.7 million in the first quarter of 2025. The 66% increase was primarily driven by increases in license and royalty revenue and increases in manufacturer and supply revenue.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

License and royalty revenue increased to $5.4 million in the first quarter of 2026 from $0.8 million in the first quarter of 2025, primarily due to the recognition of royalty revenue from Zevra. Manufacturer and supply revenue increased to $8.8 million in the first quarter of 2026 from $7.2 million in the first quarter of 2025, primarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues. Research and development expenses decreased to $4.2 million in the first quarter of 2026 from $5.4 million in the first quarter of 2025. The decrease in research and development expenses was primarily due to lower clinical trial costs associated with the Anaphylm development program, partially offset by increases in R&D personnel costs.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Selling, general, and administrative expenses decreased to $11 million in the first quarter of 2026 from $19.1 million in the first quarter of 2025. The decrease primarily represents the one-time Anaphylm PDUFA fee of $4.3 million in the prior year period, lower legal fees of approximately $3.4 million, lower commercial spending of approximately $2 million, and lower regulatory and licensing fees of approximately $0.5 million, partially offset by higher severance costs of approximately $0.6 million, higher personnel costs of approximately $0.5 million, and higher share-based compensation expenses of approximately $0.5 million.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Aquestive's net loss for the first quarter of 2026 was $8.1 million, or $0.07 for both basic and diluted loss per share, compared to the net loss in the first quarter of 2025 of $22.9 million, or $0.24 for both basic and diluted loss per share. The decrease in net loss was primarily driven by increases in revenues, decreases in selling general administrative expenses and research and development expenses, partially offset by decreases in interest income and other income net. Non-GAAP adjusted EBITDA loss was $1.7 million in the first quarter of 2026, compared to Non-GAAP adjusted EBITDA loss of $17.6 million in the first quarter of 2025. Turning to the balance sheet, we ended the first quarter of 2026 with approximately $110 million in cash and cash equivalents.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

This cash position provides us with sufficient capital to complete the remaining FDA-required studies for Anaphylm, continue advancing AQST-108 and our AdrenaVerse platform, and support ongoing operations and regulatory planning, including potential ex-U.S. regulatory filings and preparing for the U.S. commercial launch of Anaphylm if approved by the FDA. At this time, we are not updating full-year financial guidance as our near-term focus remains on execution of the remaining Anaphylm study requirements and achieving regulatory milestones. We expect to provide additional financial and operational updates as those milestones are reached. For 2026, the company expects total revenue of $46 million-$50 million and non-GAAP adjusted EBITDA loss of $35 million-$30 million as of May 13, 2026.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

In summary, the first quarter of 2026 reflects disciplined financial execution, a strong cash position, and continued focus on advancing Anaphylm towards resubmission while carefully managing expenses across the organization. With that, I will now turn the line back to the operator to open the line for questions.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the community roster. One moment for our first question. Our first question will come from the line of Roanna Ruiz from Leerink Partners. Your line is open.

Roanna Ruiz
Roanna Ruiz
Analyst at Leerink Partners

Great. Good morning, everyone. A couple from me. First on Anaphylm, could you give us a little bit more detail on how things are going preparing for the U.S. filing and ongoing study interactions or activities? It sounds like you reiterated your timeline. You know, what gives you added conviction to be able to hit that milestone?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Sure. Good morning, Roanna. Nice to hear your voice. I think that the way to think about this moment in time for Aquestive, especially with Anaphylm, is we're ready to go. We have a great team here who has the study designs completely ready. We have the sites with standing by ready to start the studies. We've given guidance on timing of when we expect to have top-line data in our August earnings. The only trigger that we are waiting for is, as we told you in our last release, the FDA reviewing our human factors protocol, which we have commitment from the FDA on the turnaround of that, which we expect to be in the next few weeks. As soon as we have that, we will start our studies and be on our way. That's where the conviction on our timing comes from. I think when you look across the broader business, you can see that we're ready to go, whether it be medical awareness or our balance sheet as well.

Roanna Ruiz
Roanna Ruiz
Analyst at Leerink Partners

Sounds good. I wanted to ask a question about AQST-108 as well. The biomarker data sounds interesting. Can you help frame that? How does that compare to other programs you've seen going after similar indications, even if they're different mechanism agents? Like, how should we think about this early signal?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Sure. I'll let Matthew Davis take that one.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

Hi, Roanna. Think about TSLP. What's intriguing about this signal is the fact that, one, it crosses across TH1, TH2-driven inflammation, JAK-STAT1, JAK-STAT2. When you think of dermatology, you would think of mechanisms that would be beneficial for alopecia areata, androgenic alopecia, atopic derm. There's a lot of optionality that this gives us. The fact that we also saw the correct orientation with CCL3 and CCL4 would be confirmational. Remember, this is directional-only data that we're looking at the right things right now. This gives AQST-108 topical a lot of optionality in the dermatologic space.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Roanna, just to add on to what Matthew said, what we like about this moment for this program is, one, we obviously are not going to lose focus on Anaphylm. Our attention remains there. We've been looking to create the data and the reasons to believe on why our AdrenaVerse platform is a meaningful way to build the company. As Matthew just walked you through, these early results show, we think we're starting to find that proof.

Roanna Ruiz
Roanna Ruiz
Analyst at Leerink Partners

Sounds great. Thanks.

Operator

Thank you. Our next question will come from the line of Kristen Kluska from Cantor. Your line is open.

Kristen Kluska
Kristen Kluska
Analyst at Cantor Fitzgerald

Hi, good morning, everybody, and congrats on all of the progress. I wanted to ask how your market research and conversations have been going about coverage and reimbursement. I think there's been a lot of great work to support the enthusiasm is there. Assuming you get an approval, what gives you confidence that you will get the coverage that the patients that want Anaphylm will be able to get their hands on it?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Good morning, Kristen. Look, I hopefully have been consistent on this point all along. Coverage and reimbursement is a struggle for every company in life sciences. There is no doubt when we launch that Sherry and her team have a lot of work to do to get coverage for the product at the level we want the product to be available to people. Sherry, I'll pass it over to her in a second here, her and her team are doing a lot of the great foundational work to make that happen. I do want to set the expectation right for everyone listening today. It will take time, and it will be something that we have to build as we go through our launch. With that, I'll let Sherry provide her view.

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

Yeah, thanks, Dan. Hi, Kristen. Good morning. you know, as we've been talking about, ensuring as many patients have access to Anaphylm is our number one priority. Rapid payer coverage and reducing the friction at our HCPs office is key. As Dan mentioned, we have watched and learned from the recent nasal launch. we see what has worked, what hasn't worked. We're adjusting our strategy accordingly. we continue to have very robust discussions with the PBMs and the payers. From the research and from our one-on-one meetings, there is significant interest in our product. as Dan has mentioned, you know, it's going to take some time. what I can assure you with, Kristen, is we are setting up a best-in-class hub and patient support services.

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

We are investing heavily into ensuring that there is as little friction, even with those prior authorizations, that there's as little friction and pain for our physicians' offices. That's the one thing we've learned, we've taken our learnings, and we're applying them to how we how and what we will do. At the end of the day, we are very, very invested ensuring that both patients and HCPs are aware of Anaphylm and then are prepared to prescribe Anaphylm and ultimately, that our patient gets their Anaphylm prescription.

Kristen Kluska
Kristen Kluska
Analyst at Cantor Fitzgerald

Okay. Thank you. Just on that awareness angle, what do you think is gonna be the biggest push that you're going to have to do in terms of getting the word out there, and how would you say potentially having this extra time since the CRL in your original planning has benefited that?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Yeah. Look, when it comes to awareness-

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

Dan, do you wanna? Go ahead.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

When it comes to awareness, I'm incredibly pleased with where we are as a company. We're definitely, in my view, I'll use the phrase punching above our weight. I'm gonna pass it over to Matt Greenhawt in a second. A lot of that is because of his efforts and the team around him and with him and their efforts out in the field. As I mentioned in the prepared comments, this year we'll be at 40 conferences and have 20 publications. That is an expensive awareness campaign. Matt, maybe you could provide some of your thoughts on what you've seen.

Matt Greenhawt
Matt Greenhawt
Chief Medical Officer at Aquestive Therapeutics

Yeah. Good morning. Hope everybody's doing well. Yeah, I mean, we've been busy. We've gone to what? 13 conferences to date. We're gonna hit over 40 ideally. You know, just writing papers. There's a lot of data. There's a great story to tell here and, you know, doing my best to get this out and hopefully, you know, this will go through publication, you know, some point this summer to early fall. You know, we go and we meet with people at these meetings. There's a lot of enthusiasm. There's a lot of excitement. It's great to have the opportunity to just sit and talk about what our story is, what we believe this product can do, and just be there to reassure and answer the questions about really anything that they wanna know.

Matt Greenhawt
Matt Greenhawt
Chief Medical Officer at Aquestive Therapeutics

It's been a nice opportunity to really get out and meet everybody. These are mostly my former colleagues, so it's, you know, it's nice to be able to interact with them and share, you know, my enthusiasm about this product and again, where we believe that this is gonna go.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

I think we see that coming through in the survey work we do when we ask, "Are you aware of our products?" You see those numbers steadily going up over time.

Kristen Kluska
Kristen Kluska
Analyst at Cantor Fitzgerald

Thanks, everyone.

Operator

Thank you. Our next question will come from the line of David Amsellem from Piper Sandler. Your line is open.

Analyst at Piper Sandler

Hi, everyone. This is [now gone] for David. Thanks for taking our questions. Just a couple quick ones from us. First with neffy, now that that's been on the market for around 18 months, can you elaborate on the learnings from that launch that are influencing any changes to your commercialization strategy? That's number one. Number two, with the Oaktree financing in place and the pre-approval conditions for the additional RTW financing met, is that sufficient runway through the launch of Anaphylm? If you could provide some clarification there, that'd be great. Thank you.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Sure. Yeah. Well, let me go in reverse order, let's start with Oaktree. I'm gonna pass it over to Ernie for a minute here. From our perspective, I'll open with that piece by saying, look, we're incredibly excited about the relationship with Oaktree. Now with both RTW and Oaktree, as key backers of the organization, we think we're well-positioned. Ernie can give you his thoughts on the runway through the launch.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Certainly. You mentioned with the refinancing of the existing debt with Oaktree, that satisfied the second condition for under or first condition under RTW, was that we refinance our existing debt, so we have access to that capital. Second being that we get approval on Anaphylm. As we've said publicly, both in our oral and written statements, that this provides us runway through the launch next year. If approved, it puts the company in probably the best capital position it has ever been, and we feel confident that we'll have the funds in place ready to launch on approval of Anaphylm.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Let me go back to your first question, which was on the learnings from neffy. I'll give you my thought, and then I'll ask Sherry to also give hers. For me, I think the key learning is no matter how innovative your product, and we clearly believe our product is innovative and potentially transformative in this space, you can't take anything for granted. All of the hard work that the basic blocking and tackling work of launching a drug, being out in front of the doctors, telling your story, getting coverage, all of that you have to do no matter how innovative your product is. We are definitely focused on making sure we're ready to do all of that hard work. Sherry, I'll let you add your thoughts to that as well.

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

Sure. Thanks so much. Thanks so much for the question. You know, look, as you know, having a non-device oral easiest to carry epinephrine, it is a game changer in the marketplace. Again, as Dan mentioned, no matter, you know, you build a better mousetrap, that doesn't necessarily mean it will come. We've seen this in this marketplace. As you know, I ran the EpiPen brand, and we saw the same thing happen with Auvi-Q. Just because you build a better mousetrap doesn't mean that everyone will come. What have we learned? I think one is how do we reduce that friction?

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

As I just mentioned to Kristen, we are really working hard in our very robust discussions with the PBMs and payers, but also working on setting up the best-in-class hub and support services to support the offices. I think we heard from ARS back in their March earnings call, is that they were kind of doubling down in the allergist space, increasing reach and frequency in the allergists. We know that this market is driven by the allergists and the high prescribing pediatricians. Our plan, as you know, we've moved to 75 reps, as well as then obviously the managers and the support around that, is critical to drive this product forward.

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

Look, I think at the end of the day, reducing friction in the physician's office is critical. Ensuring that physicians and patients have awareness and really driving believability in the product. Matt's team is out there doing a fantastic job. I mean, our market research shows the awareness with the HCPs has gone from a 33%-66%. The increased effort in publications and all the medical work that is being done will only continue to do that. That only gets us so far, right? With the awareness. We have to have doctors believe in it. All of the scientific work Matt and his team are doing, the publications we will continue to put out are critically important. Physicians have to get experience with the product in their office. You know, we will look to launch a program upon approval so physicians can get that actual real-world experience.

Analyst at Piper Sandler

Great. Thank you.

Sherry Korczynski
Sherry Korczynski
Chief Commercial Officer at Aquestive Therapeutics

Does that answer your question, David?

Analyst at Piper Sandler

It does. Thanks.

Operator

Thank you. Our next question comes from the line of Francois Brisebois from LifeSci Capital. Your line is open.

Francois Brisebois
Francois Brisebois
Analyst at LifeSci Capital

Hey, guys. Thanks for the questions here. I was just wondering on that friction pain in the physician's office, is this something where it's kind of, it's always the same issue? Is there one problem that seems to be recurrent everywhere that's easily fixable, or is this a situation where it depends on the practice, it depends on the state, it depends on the doctor? How far can you guys go in terms of better understanding, if you have to do like a custom approach to each office or is there something where it's like, I think we've got something here that is the main problem most of the time?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Morning, Frank. Good to hear your voice. I'll say, let me position it this way, while we're working on it and Sherry gave you the kind of the big overview. We definitely will be keeping a decent amount of our playbook to ourselves. Yes, we do see opportunity on how to manage the friction. We do, as Sherry talked about, see some of the basic steps that every company takes, like having a good hub, like being there with frequency. In terms of the tailor-made approach and how we tackle that, some of that we're gonna hold back on for right now. I guess the way I'll leave it with you is more to come.

Francois Brisebois
Francois Brisebois
Analyst at LifeSci Capital

Okay, great. On the in terms of the FDA, there's just so much with you guys with the FDA right now. Has the personnel changed? Any updates? There's obviously been quite a bit of change with the FDA. Anything in terms of your case that has changed or has been more worrisome about this timing? I think you guys are waiting on the review from the Human Factors Protocol. In terms of timeline and expectations and comfort, then you mentioned there could be a possibility where things even accelerate. Can you just dig a little bit more into your what you can share about FDA interactions?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Sure. Well, I'll talk about the acceleration piece, and then I'll pass it over to Melina to talk about her view on the stability of the people we're interacting with. To be clear, it is as we believe we will be assigned a six-month review clock, because that would seem what the statutes are saying. We firmly believe that the package we're going to be putting in, as all of us are aware, will be the human factors study and the PK study that we're doing, and that's it. We do believe there's an opportunity to say to the FDA, this is a limited package, and it shouldn't require the full six months. We also would note there's precedence for that in the other recent branded product in this space. That will be our approach on pushing for, hopefully action sooner than the full six months. In terms of the stability of the individuals at the FDA, I'll pass it over to Melina.

Melina Cioffi
Melina Cioffi
SVP of Regulatory Affairs at Aquestive Therapeutics

Thank you. Good morning, Frank. The team, the review team across the board, across the various divisions, remain intact, meaning that these are the same individuals that have worked with us early on during the development of the product as well as during the review. We foresee no abrupt changes at this point.

Francois Brisebois
Francois Brisebois
Analyst at LifeSci Capital

All right. Thank you very much.

Operator

Thank you. Our next question comes from the line of Mazahir Alimohamed from Oppenheimer. Your line is open.

Mazahir Alimohamed
Mazahir Alimohamed
Analyst at Oppenheimer

Good morning, everyone. Thank you for taking our questions, and thank you for the really comprehensive earnings call. Just a couple for once. I guess the first one is in terms of the Zevra royalty, how should we think about this $5.4 million? Is that a run rate figure, or were there any catch-up payments in Q1 that make this a high water mark for the year? Then kind of one more that's a little bit more mechanistic on this TSLP biomarker. Kinda seems like JAK1/2 sits downstream of TSLP signaling and that JAK inhibitors which currently carry the black box warning largely due to their exposure, could limit the uptake. I guess, how confident are you that AQST's topical delivery profile would avoid the systemic JAK inhibition risks that currently limit the oral agents? Thank you.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

I'll let Ernie start with the Zevra royalty and then go to Matthew for the TSLP.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Hi, Mazi. No, you should not think of this as run rate for the year. You know, you gotta remember that what we receive from Zevra is a part of an agreement we have with them where we have an economic interest in one of their products, Azstarys. Zevra recently sold that product and as a result of that, received a $50 million payment, of which we were entitled to 10% of. That is what accounts for the $5 million, approximately $5 million in the first quarter.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Let's turn to, your question on TSLP, which I'll give to Matthew.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

That's an absolutely great question. When you think about the broad-based nature of immunomodulation when it comes to the AdrenaVerse, you should think that we're not a specific actor inhibiting one pathway. The healthy normal subjects that volunteered for this trial did not have an elevated TSLP. They did not have elevated CCL3, CCL4. The topical AQST-108 did not actually modulate those patients. The patients that had androgenic alopecia, there's not a broad-based inflammatory condition, but they did have elevated TSLP, and the topical 108 did reduce that directionally. Our preclinical research and also the published literature says that topical beta-2 agonists have a broad-based immunomodulator. They're not specifically targeting one pathway. A JAK inhibitor specifically basically targets one pathway.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

As the program advances, we'll find out more about it, and we will inform you as we get more data. That's sort of the differentiation between a broad-based modulation versus a single pathway inhibitor.

Mazahir Alimohamed
Mazahir Alimohamed
Analyst at Oppenheimer

Very helpful. Thank you for the added color.

Operator

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

Jan Zi
Jan Zi
Analyst at H.C. Wainwright

Hi. Good morning. Thank you for taking my question. This is Jan Zi sitting in for Ram. I have a few questions. The first is for Anaphylm. For Anaphylm ex-U.S., you said that you have existing clinical data that's enough to support filings in Canada, EU, UK and so on. I'm just wondering, how are you thinking about sequencing, partnering, you know, price access, all the works, and the retained economics across those markets?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Sure. Yeah. And we can go into further detail if you want on the existing clinical piece, but as Melina and her team have worked very hard, we've met with the regulatory bodies in Canada, U.K., and EMA. That's where our comfort comes from, that the existing clinical package is sufficient, and we are working rapidly towards regulatory filings in multiple jurisdictions. From that perspective, we're in good shape. From the partnering perspective, we're well on our way in Europe in particular. I would say the economics are similar to what you would expect for a program at this stage. We do understand the markets. We've done our work in those markets.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

We understand what we should retain versus what a partner should be able to also be rewarded and feel good about. I think those I would guide you to being within industry norms. In terms of timing, I've learned over the year with BD deals, timing is always a tricky thing. What I would tell you is we are on our way, and when we get to the right place, you guys will be the first to know.

Jan Zi
Jan Zi
Analyst at H.C. Wainwright

Great. Thank you. Now with respect to the Oaktree facility, would you be able to disclose what the payment prepayment provisions are there? For example, like what are the cash restrictions, for example?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

I think everything is disclosed in the 8-K. It's pretty extensive disclosure on the covenants and the restrictions and everything, so I would refer you to it. I would just broadly say, we are happy with not only the quality of the debt provider we have with Oaktree, but the ability to run our business and grow our business without being restrained. We think that is a key part of this announcement.

Jan Zi
Jan Zi
Analyst at H.C. Wainwright

Great. Thank you so much.

Operator

Thank you. Once again, that's star one one for questions, star one one. Our next question comes from line of James Molloy from Alliance Global Partners. Your line is open.

Laura Suriel
Laura Suriel
Analyst at Alliance Global Partners

Hello, this is Laura in for James Molloy. Thank you for taking our questions. For AQST-108, you've touched on this already a bit, but how do you think you're going to further look into the TSLP biomarker data in future studies for 108? How meaningful do you think this finding is for the atopic dermatitis indication specifically that you're looking to study?

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Sure. I'll pass it over to Matthew in a second, but I would say, you know, we're definitely excited. It is definitely a positive thing and something that we're happy to see and confirmatory of what we thought we would see. As Matthew guided, it is early stage, it is early stage information. I also do want to just reiterate that in the short term, so over these next few months, everyone's brainpower, resources, time, including Matthew's, will be heavily geared towards making sure we get our Anaphylm resubmission right. That is definitely priority number one. I'll let Matthew give you his thoughts on what might come next.

Matthew Davis
Matthew Davis
Chief Development Officer at Aquestive Therapeutics

I'm very, very excited about the direction of discovery of the TSLP, please remember this is one of many biomarkers. It guides you towards inflammatory states dermatologically and topically, also in additional programs, we want to expand upon the biomarkers and the utilization of biomarkers because we believe based on literature and based on our own preclinical work, that there is a lot of opportunity, and we believe that the topical beta-2 blockers and the AdrenaVerse in general really can have the potential of being a broad-based immunomodulator. As we develop our programs, once we're done with Anaphylm, we will guide everyone of what direction we're going and what information we're gonna be looking at. This is a really exciting first step.

Laura Suriel
Laura Suriel
Analyst at Alliance Global Partners

Got it. Thank you. Also for Anaphylm, with plans to expand globally, are you still on track to file for full submission to the EMA and Health Canada by the end of the year? How would you just compare the overall U.S. versus ex-U.S. timing? Thank you.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Well, the U.S. timing, obviously, we've been very open about, but we continue to guide to a Q3 submission. We think it's a six-month review. We're going to try to get the review to be faster. Obviously the math there is pretty basic. On Canada, we continue to see a 2026 filing. On Europe, we're definitely shooting for a 2026 filing. We're gonna be right up against the New Year's holiday where that falls. Whether that is late Q4 or early Q1, I'm not sure that the calendar turn is what matters on that so much as getting it right and getting it in as fast as we can.

Laura Suriel
Laura Suriel
Analyst at Alliance Global Partners

Great. Thank you for taking the questions.

Operator

Thank you. I'm not showing any further questions at this time. I would now like to turn it back over to Dan Barber for closing remarks.

Dan Barber
Dan Barber
CEO at Aquestive Therapeutics

Thank you, Victor. As I said earlier in the call, we are, in our view, ready to go. We're ready to conduct our studies. We're ready to build our awareness even further. If approved by the FDA, we're on track to launch Anaphylm. We look forward to updating you on our additional progress in the months to come. With that, thank you for joining us, and have a great day.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

Executives
    • Dan Barber
      Dan Barber
      CEO
    • Ernie Toth
      Ernie Toth
      CFO
    • Faith Pomeroy-Ward
      Faith Pomeroy-Ward
      Corporate Communications and Investor Relations Strategist
    • Matt Greenhawt
      Matt Greenhawt
      Chief Medical Officer
    • Matthew Davis
      Matthew Davis
      Chief Development Officer
    • Melina Cioffi
      Melina Cioffi
      SVP of Regulatory Affairs
    • Sherry Korczynski
      Sherry Korczynski
      Chief Commercial Officer
Analysts
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