Aquestive Therapeutics Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 12, 2025

Key Takeaways

  • Positive Sentiment: We remain on track for the FDA PDUFA action date of 01/31/2026 for Anafilm, having completed the 120-day safety update and conducted an in-house mock advisory committee session.
  • Positive Sentiment: The rescue epinephrine market could grow from 5 million to 10 million prescriptions and exceed $2 billion annually as 90% of users shift to non-injectables and surveys show patients favor the convenience of Anafilm.
  • Negative Sentiment: Payer tactics such as NDC blocks, prior authorizations, and rising deductibles are creating barriers to Anafilm access and driving up costs for patients and manufacturers.
  • Positive Sentiment: To overcome coverage hurdles, Aquestive will offer a patient-first cash pay program on day one of launch to ensure immediate access for patients facing payer restrictions.
  • Positive Sentiment: Aquestive ended Q2 with $60.5 million in cash, is exploring non-dilutive and debt financing pathways for the Anafilm launch, and remains confident in securing additional funding.
AI Generated. May Contain Errors.
Earnings Conference Call
Aquestive Therapeutics Q2 2025
00:00 / 00:00

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Operator

Good day, and thank you for standing by. Welcome to the Aquestive Therapeutics Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in listen only mode. After the speakers' presentation, there'll be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone.

Operator

You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Ryan Korb. Please go ahead.

Brian Korb
Co-founder & Managing Partner at Astr Partners

Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the 2025, followed by a Q and A session. During the Q and

Brian Korb
Co-founder & Managing Partner at Astr Partners

A session, the team will be joined by Doctor. Karl Krausz, Chief Medical Officer and Sherry Korchinski, Chief Commercial Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call will be made available on Aquestive's website within the Investors section shortly following the conclusion of this call. To remind you, the Aquestive team will be discussing some non GAAP financial measures this morning as part of its review of second quarter twenty twenty five results.

Brian Korb
Co-founder & Managing Partner at Astr Partners

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 yesterday'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 quarterly report on the Form 10 Q filed with the the Securities and Exchange Commission on 08/11/2025. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward looking statements, which speak only as of the date made.

Brian Korb
Co-founder & Managing Partner at Astr Partners

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.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Thanks, Brian, and good morning, everyone. We are now less than six months away from our FDA action date for antifilm epinephrine sublingual film, potentially the first and only oral product for the treatment of severe allergic reactions, including anaphylaxis. As a reminder, our action date is scheduled for 01/31/2026. I'm pleased to tell you this morning that we are on track across the important elements of Anafel. We are on track in our FDA review process, our Anafilm Advisory Committee preparations, which may or may not occur, and our pre commercial launch activities.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

We are on track in responsibly securing launch financing for the company and we are on track in our international expansion efforts for Anafilm. Let's start with the FDA review of our Anafilm application. We recently submitted our one hundred and twenty day safety update to the FDA. I'm pleased to say that there was nothing new or of consequence to report in this safety update. We also believe the FDA is about to conclude its mid cycle review.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

While we do not participate in this review, we would expect to have more clarity on whether we will have an advisory committee meeting once the FDA has fully processed its mid cycle review meeting. In terms of advisory committee meeting preparations, we recently completed our first in house mock or practice advisory committee meeting, including participation from our key opinion leaders. We were pleased with the results and continue to strengthen our discussion points every week. It's also worth noting that we have included our pediatric study data in the supplemental materials on our website. As we have discussed before, this data was in line with expectations and importantly enabled us to submit our NDA for patients down to 30 or approximately seven years of age.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Now let's turn to our pre commercial activities. As a starting point, it's important to remember that we continue to believe the rescue market for severe allergic reactions is poised for growth for years to come. Before the launch of a nasal spray last year, there had been very little innovation and very little physician detailing in this space for quite some time. When we launch, if we are approved by the FDA, there will be only a few companies detailing physicians and highlighting the need for patients to carry and use rescue medications for severe allergic reactions. I believe that this along with the underlying market growth should propel the market from roughly 5,000,000 prescriptions a year to as many as 10,000,000 prescriptions a year.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Using the estimated current net prices of today's epinephrine products, this could be as much as or more than $2,000,000,000 a year in global market. A recent survey conducted by an expert research analyst in this space concluded that 90% of the market will move from injectables to non injectable products over the years to come. And in our surveys, we found that when patients are presented with a choice between injectables, nasal sprays and oral films, they favor the convenience, size, durability and oral administration of ANNAFILM. We believe this market remains a compelling opportunity for Aquestive and its stakeholders, especially patients and caregivers, if approved by the FDA. Let's focus on patients and caregivers for a moment.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

According to one of the leading allergy advocacy groups, the Allergy and Asthma Network, an estimated two twenty five Americans die each year from anaphylaxis. Sadly, it seems that this rate has not improved in decades. We believe the way to improve bad outcomes is to one, improve the carry rate, two, lower the barrier to use, and three, ensure broad availability and coverage. We think the inherent characteristics of ANNAFILM will address the first two items because ANNAFILM fits patients' lives. Unfortunately, the third item, market access, is harder.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

We have been disappointed to see the number of barriers that the most recently approved epinephrine product has faced when it comes to market access. Pricing and product access should not prevent patients from having access to lifesaving medicines. Delayed tactics, NDC blocks and prior authorization documentation are just a few ways that payers make it hard for patients to get the drugs that they need. And for pharmaceutical manufacturers like us, these barriers add significant costs to putting our products into the hands of patients. Simply put, Americans are not getting the coverage they expect through the healthcare insurance that they pay for.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

In fact, some companies have indicated that the average healthcare plan deductible for a single person has risen from roughly $900 in 2010 to $1,800 in 2024. And it is still climbing. As you can imagine, the deductibles are considerably higher for a family. That is why for ANNAFILM, we will be taking a patient first approach. On day one, we will have a cash pay program available to patients and caregivers.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

While we are not announcing our pricing today, we will do everything we can to make sure that patients have immediate access to Anafilm, even if their provider puts up barriers to access. We will share more details on this program as we get closer to approval and launch. Additionally, our market access group possesses significant enterprise level pricing, contracting, coding and reimbursement, trade and distribution, patient services and government affairs experience. The team is engaging with payers as you would expect at this point in the approval process of Anafel. Now let's turn to financing the launch.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

As you saw in our press release, we ended the last quarter with $60,000,000 in cash. While this is sufficient for the initial launch, we will need more funding to appropriately support Anafel. Ernie will talk more about our financials, but I do want to give you my perspective on our pathways to financing the launch. We currently have multiple proposals in process including for EU only rights and alternate financing vehicles. We are working through the pathways available to the company and will select the best pathway when the time is right.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

However, as of today, we remain confident that launch financing is available to the company and that we will have secured financing prior to launch. The final update for ANNAFILM is on the international front. We have secured meetings in both candidate and the EU for discussion on the filing packages necessary with each regulatory body. Our plan remains to complete these meetings by the end of the year and then begin the work to prepare and submit filings. Regarding the remainder of our business, we continue to make progress.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

We continue to believe AQST-one hundred eight, our epinephrine topical gel, could provide a compelling improvement for patients with alopecia areata. We are on track to open our IND with the FDA before the end of the year and begin our next human studies in early twenty twenty six. Our base business grew year over year in the second quarter when adjusted for one time revenue events. This was driven by strong growth in our international products. We continue to work towards offsetting the decline of Suboxone with new business opportunities.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

In conclusion, we remain on track for a launch of ANNAFILM in the 2026, if approved by the FDA. Our focus remains on our interactions with the FDA, finalizing our launch financing and pre commercial activities. Now 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 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 second quarter twenty twenty five results in the Q and A. During the second quarter, we continued to execute on our strategy to support the continued development of the recently filed NDA for ANNAFILM, our lead product candidate that has no needle, is not a device, is orally administered and is easy to carry.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

This includes supporting pre approval launch activities for antifilm to increase awareness among physicians, payers, and the advocacy community as we approach the PDUFA action date of 01/31/2026. As Dan mentioned, we continue to evaluate all financing alternatives to support the commercial launch of ANNAFILM if approved by the FDA. This includes non dilutive alternatives such as the sale of global rights, EU only rights, refinancing our existing debt, additional debt, as well as revenue interest financing. We are evaluating all options structure to support the future growth of Aquestive. Aquestive's manufacturing business remains steady, with the gradual decline of Suboxone being offset by growth across newer collaborations, including for the licensed products Ondif, SYMPAZAN and EMILIF.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Aquesta's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations. In addition, the company being a US based manufacturer with intellectual property domiciled in The US has a supply chain which currently remains 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 second quarter results. Excluding the impact of one time recognition of deferred revenue in the 2024, total revenues increased by $300,000 or 3% year over year to $10,000,000 in the second quarter twenty twenty five. As a reminder, the one time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Including the deferred revenue recognized in the prior year, total revenues decreased to $10,000,000 in the 2025 from $20,100,000 in the 2024. Manufacturer and supply revenue increased to $9,600,000 in the second quarter twenty twenty five from $8,100,000 in the second quarter twenty twenty four, primarily due to increases in ONDEEP revenues, partially offset by decreases in Suboxone revenues. Total revenues decreased to $18,700,000 for the six months ended 06/30/2025, from $32,200,000 for the six months ended 06/30/2024 due to one time recognition of deferred revenue in the prior year. Excluding this one time recognition of deferred revenue, total revenues decreased by $2,800,000 or 13% year over year. Manufacturer and supply revenue decreased to $16,800,000 for the six months ended 06/30/2025, from $18,600,000 for the six months ended 06/30/2024, primarily due to decreases in Suboxone revenues, partially offset by increases in ONVIF revenues.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Research and development expenses in the '5 remained relatively consistent compared to the 2024. Research and development expenses decreased to $9,500,000 for the six months ended 06/30/2025, from $10,100,000 for the six months ended 06/30/2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the antifilm program, partially offset by increases in personnel costs and an increase in share based compensation. Selling, general and administrative expenses increased to $12,700,000 in the second quarter twenty twenty five from $11,400,000 in the second quarter twenty twenty four, primarily due to higher commercial spending for prelaunch activities of approximately $2,000,000 higher regulatory and licensing fees of approximately $800,000 higher personnel costs of approximately $400,000 higher share based compensation expenses of approximately $200,000 and higher consulting fees of approximately $200,000 partially offset by lower legal fees of approximately $2,500,000 and lower insurance expenses of $200,000 Selling, general and administrative expenses increased to $31,800,000 for the six months ended 06/30/2025 from $22,000,000 for the six months ended 06/30/2024. The increase primarily represents regulatory fees related to the ANIFILM PDUFA fee of approximately $4,300,000 higher commercial spending on prelaunch activities for ANNAFILM of approximately $4,200,000 higher regulatory and licensing fees of approximately $1,500,000 higher personnel costs of approximately $800,000 higher share based compensation expenses of approximately $500,000 and higher consulting fees of approximately $300,000 all partially offset by decreases in severance costs of approximately $1,100,000 lower insurance expenses of approximately $500,000 and lower legal fees of approximately $400,000 Aquestive's net loss for the second quarter twenty twenty five was $13,500,000 or $0.14 for both basic and diluted loss per share compared to the net loss for the 2024 of $2,700,000 or $03 for both basic and diluted loss per share.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

Excluding the impact of onetime recognition of deferred revenue, the net loss in the second quarter twenty twenty four was $13,200,000 Aquestive's net loss for the six months ended 06/30/2025 was $36,500,000 or zero three seven dollars for both basic and diluted loss per share compared to the net loss for the six months ended 06/30/2024 of $15,600,000 or $0.19 for both basic and diluted loss per share. Excluding the impact of onetime recognition of deferred revenue, the net loss for the six months ended 06/30/2024, was $26,000,000 Non GAAP adjusted EBITDA loss was $9,300,000 in the 2025 compared to non GAAP adjusted EBITDA income of 1,800,000 in the 2024. Excluding the impact of the one time recognition of deferred revenue, non GAAP adjusted EBITDA loss in the 2024 was $8,600,000 Non GAAP adjusted EBITDA loss was $27,000,000 for the six months ended 06/30/2025, compared to non GAAP adjusted EBITDA loss of $5,400,000 for the six months ended 06/30/2024. Again, excluding the impact of one time recognition of deferred revenue, non GAAP adjusted EBITDA loss for the six months ended 06/30/2024 was $15,800,000 Cash and cash equivalents were $60,500,000 as of 06/30/2025. Aquesta's full year 2025 financial guidance remains unchanged.

Ernie Toth
Ernie Toth
CFO at Aquestive Therapeutics

The company 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. As a reminder, our 2024 revenue included onetime nonrecurring recognition of deferred revenue related to the termination of certain licensing and supplier agreements. Our non GAAP adjusted EBITDA loss guidance for 2025 includes significant preapproval launch spending for ANNOFELM, costs associated with the recent submission of the ANNOFELM NDA and related filing fee, completion of the ANNOFELM pediatric clinical trial, and preparations for a potential advisory committee meeting, if required, by the FDA for approval of Anafelm. With that, I will now turn the line back to the operator to open the line for questions.

Operator

Thank you. At this time, we'll conduct a question and answer session. Please standby while we compile the Q and A roster. And our first question comes from the line of Rona Ruiz of Leerink. Your line is now open.

Mazahir Alimohamed
Biotech Equity Research at Leerink Partners

Hello. Yes, good morning. So, wanted to touch base. This is Maisie on for Rona Ruiz. But just wanted to touch base.

Mazahir Alimohamed
Biotech Equity Research at Leerink Partners

So, we mentioned the possible FDA AdCom meeting ahead of the PDUFA. Could you provide any more details on the likelihood of the AdCom being required and how confident you are in your clinical data package going into this?

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Sure. This is Mazie, right?

Mazahir Alimohamed
Biotech Equity Research at Leerink Partners

Yes, it is.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Nice to hear your voice. So, in terms of the likelihood of an AdCom, nothing has changed on that front since our last conversation. As you know, the FDA obviously accepted our application back in June, where they reiterated that they may or may not want to have an advisory committee meeting. By our math, the FDA should be just about in the process of having its mid cycle review, and we would continue to believe that in the coming weeks, to a month call it, we would have an indication from them of whether they want an AdCom or not. So again, from our perspective, the important part is to be ready, and we have focused a lot of energy and time on making sure that we are ready for any AdCom if the FDA desires.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

In terms of how we feel about our clinical package, I will pass it over to Karl to give you his high level view.

Carl Kraus
Carl Kraus
Chief Medical Officer at Aquestive Therapeutics

Yeah, I the question, and

Carl Kraus
Carl Kraus
Chief Medical Officer at Aquestive Therapeutics

I believe we may have commented on that last discussion as well, which is that the package is quite robust, we probably have one of the largest epinephrine studies conducted to date, the package consists of 10 independent studies, well over nine thirty plus exposures, and well over three fifty subjects. It's a robust package, it should be able to address any and all potential questions that the agency may have, so we're very proud of it and We believe it's a strong package.

Mazahir Alimohamed
Biotech Equity Research at Leerink Partners

Great. Thank you both for your response. We look forward to seeing it play out.

Operator

Thank you. One moment for our next question. Our next question comes from the line of David Amsellem of Piper Sandler. Your line is now open.

David Amsellem
David Amsellem
MD & Senior Research Analyst at Piper Sandler Companies

Thanks. So just have a couple. Interested in your comments regarding out of pocket exposure for patients and just the payer landscape. And I guess my question here is, is your commentary a function, not only what you're seeing with your competitor, the the nasal spray formulation, but also a function of your discussions with payers? Maybe talk to the extent of your discussion with payers, how that's going and how you're thinking about access issues.

David Amsellem
David Amsellem
MD & Senior Research Analyst at Piper Sandler Companies

So that's number one. And then number two, regarding the cash pay initiative, I guess my question here is how much of the intranasal business is actually cash pay? And what kind of cash pay market do you think is going to evolve into over time? And just trying to get a better understanding of your thought process here. Thank you.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Sure, thanks David, good morning. So let me start with what we're doing. So from discussion with payers, Sherry Korchinski, who's here with me this morning, and her team have done a great job of engaging on the payer landscape. We have some really solid expertise in house, and so to the extent that the pre commercial world allows you to engage with the payers, we are obviously engaged with the payers. Those discussions do not, at this time, get to a place where we talk about coverage or what that would look like, that's not obviously allowed until approval, so right now our focus with payers is strictly on awareness.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

In terms of the out of pocket exposure in the payer landscape, my commentary would be for our entire industry. I don't think there's a single drug that gets launched right now that doesn't have concerns over how their patients get the product that they need without extreme or additional issues in the chain of getting a product. So I wouldn't say that is specific to just the nasal spray. In terms of cash pay, I'll leave it to our competitor to talk about what percentage of their business is cash pay or isn't cash pay. When we look across the landscape, our view is that cash pay is an important part of any product that is launching in the near term, and we think that given the trends of how the payer world works, that is likely to continue.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Over time, we would expect for most drugs, other than, call it, very highly priced drugs, that the cash pay portion will continue to grow and be a significant portion. In terms of what it can ultimately be for antifilm, I think that will really be informed by the market.

David Amsellem
David Amsellem
MD & Senior Research Analyst at Piper Sandler Companies

That's helpful. If I may just sneak in a follow-up. To the extent that you're going to be buying down here and this is a key product, This is in chronic treatment. As you think about that, where does copay buy down play into your overall strategy and how should we think about that? Thanks.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Yeah, look, our role right now, our job right now beyond getting the product approved and available to patients, is to make sure that they have access in a reasonable fashion. So not just us, but every company utilizes the co pay buy down program. Obviously the important part with the co pay buy down program is to make sure it's balanced, that you balance it with the coverage that you are either getting or have versus where you are at that state. So I don't think you'll see us do anything that is out of the ordinary on copay buydowns, but we absolutely will have it as a part of our world.

David Amsellem
David Amsellem
MD & Senior Research Analyst at Piper Sandler Companies

Okay. Thanks, guys.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Kristen Klisko of Cantor Fitzgerald. Your line is now open.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Hi, good morning everyone. Thanks for taking the question. So recently former CRLs were made publicly available, including one from your peer who now has an approval. I know you're in a unique position, because you're differentiated, but also you get to leverage that experience to help with your own prep. So, I'm curious if you reviewed any of these documents and anything that you can really gain from material beyond what we already knew, including from the AdCom experience.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Sure. Thank you, Kristen. Yes, of course, one of the benefits of being second is you get to see what the person who was ahead of you or the company that was ahead of you went through. So both from an AdCom and a CRL perspective, we have definitely watched and tried to learn. Our biggest learning, and I'll focus on the CRL, though I think it played into the AdCom as well, our biggest learning is kind of an age old one for us, as a reminder we have six FDA approvals over the years, which is listen to the FDA.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

So our read of the CRL is there was a study that was not completely done the way that the FDA wanted it to be done, and our competitor had to go back and do that. So in our package, and Carl talked before about the completeness of our package, one of the things we really focused on was making sure we did everything that the FDA asked for. So to be specific, in our oral allergy syndrome study, we did not just a single dose, but a repeat dose arm. That was specifically listening to what the FDA had asked for, and ties to the allergic rhinitis component of the CRL that you referenced.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Andreas Eigreitz of Oppenheimer. Your line is now open.

Andreas Argyrides
ED & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Great. Good morning and thanks for the, for taking our questions and and the update here guys. Just quick one on us. You we see that you provided some additional details on the pediatric study, PKPD, which is great. Can you give us a little bit more color on the safety?

Andreas Argyrides
ED & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

And then how confident are you in the submission for peds as part of the NDA submission? Thank you.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Sure, and good morning Andreas. I'll pass it over to Karl in a second here. I'll just open with, as Karl said at the top of this Q and A session, we're confident in the package we've put together. We think it's a robust package and the right one for what we're looking to accomplish. But I'll let Carl talk on the pediatric study specifically.

Carl Kraus
Carl Kraus
Chief Medical Officer at Aquestive Therapeutics

Yeah, no, thanks for the question. The pediatric study was crafted in such a way really just to provide characterization of the concentration time curve and the PK profile in that population. There was no internal comparator per se that was agreed upon with the agency, but we have done cross study evaluations showing that it's quite comparable to the adult dose, and as you saw in the supplementary slides, you can almost see overlapping concentration time curves between the pediatric and adult studies. So from that perspective, the powering the addressing FDA's concerns and requests for the appropriate number of subjects, and also the subsequent PK profile that we saw at the outcome. We're extremely pleased with those data.

Carl Kraus
Carl Kraus
Chief Medical Officer at Aquestive Therapeutics

As far as safety goes, there was no difference really in the character, frequency, or severity of outcomes that we saw in the pediatric population. So overall, quite in line with what we were hoping for and expected.

Andreas Argyrides
ED & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Okay, was my question. Thanks.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Jason Butler of Citizen JMP. Your line is now open.

Jason Butler
Jason Butler
MD & Biotechnology Equity Research at JMP Group LLC

Hi. Thanks for taking the questions. Two for me. The first one, you mentioned that you did submitted the 120 safety update. Just wondering if there have been any other substantial data analysis or information requests from FDA during the review so far?

Jason Butler
Jason Butler
MD & Biotechnology Equity Research at JMP Group LLC

And then second, on the commercial prep, you talked about the reimbursement piece. Can you also just talk about the work you've done to increase awareness of ANNAFILM and where you think you've whether or not you've moved the needle there? Thanks.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Good morning, Jason. Good to hear your voice. So, on the first one, we have had the usual back and forth with the FDA that you would expect to date. There is nothing that I would describe as a major data set or anything to that standpoint beyond the standard one hundred and twenty day safety update. In terms of our awareness activities, I'll turn it over to Sherri to give you her view.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

Sure, thanks so much for your question. As Dan mentioned in his comments, we continue to drive significant awareness of the brand, and what we're hearing back is consistent. The feedback from the broader allergy community, both patients and HCPs, continues to be positive. We have been conducting CME, non CME. We have had a number of posters and have been very active in the medical side of things, being at local, regional, and national conferences.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

So we have really spent the entire year increasing the awareness of antifilm, and at the end of the day, what the ATPs continue to tell us is that they love the product. They believe it will improve the carry rate and it will decrease the barriers to use.

Jason Butler
Jason Butler
MD & Biotechnology Equity Research at JMP Group LLC

Great, thank you.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Ram Seraju of H. C. Wainwright and Co. Your line is now open.

Daniel Smith
Equity Research Associate at H.C. Wainwright & Co.

Good morning. This is Dan on for Ron. Thanks for taking our questions. So we were curious kind of, in terms of business development strategy related to Anaheim. Is the question planning to partner the drug ahead of regulatory applications in ex U.

Daniel Smith
Equity Research Associate at H.C. Wainwright & Co.

S. Territories or wait until those filings have been submitted? And how is the quest of thinking about ex U. S. Pricing in the context of most favored nations? Thank you.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Good morning, Dan. Thanks for the questions. So we've been pretty open all along, probably for the better part of a couple of years now. From our perspective, our number one job is to make sure that antifilm gets put into the hands of as many patients as it can be useful for. So from that perspective, we are always looking at how to have the broadest coverage and the broadest capabilities, Whether that is ultimately a launch just by the company, or a launch in conjunction with another company is something we continue to talk through, as I said in my comments at the beginning.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

In terms of ex US pricing and most favored nation pricing, don't see, while I suppose it will have an impact on all companies in the space, I think the primary impact will be on the larger companies that have very expensive drugs. I think if you look at this rescue market, you have a rescue treatment that is usually only filled once a year, so it's not a chronic medication, and the price point on the product is obviously way below some of the high priced biologics or something like that. So I don't think we're the target of those activities, I wouldn't expect them to be a major component of how things play out here.

Daniel Smith
Equity Research Associate at H.C. Wainwright & Co.

Thank you.

Operator

Thank you. One moment for our next question. Next question comes from the line of Gary Nachman of Raymond James. Your line is now open.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Hey, guys. Good morning. This is Dennis Resnick on for Gary Nachman. Thanks for taking our questions. So in terms of the pre commercial efforts, can you detail what the ideal physician who would be a top desktop prescriber of Anafilm looks like?

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

There any characteristics about them that you'd highlight? And then just given some of the headwinds it sounds like you're seeing on the payer landscape, are you still confident that you can likely get 80% coverage within the first six months of launch? Thanks so much.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Morning, Dennis. Let me take the second one first, then I'll pass it over to Sherri for the ideal physician. So yeah, we are confident that from a payer perspective, we will have broad coverage, and that that coverage will be competitive with the other products available in the space. The 80% mark, I don't know how to feel about that, but I would generally say yes, we'll have broad coverage across most people. But why don't I pass it over to Sherry, she can give you her thoughts on the ideal physician.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

It's a good question. And I always like to say that this market is an inch deep and about 10,000 miles wide. And what I mean by that is you have a very, very broad range of physicians that prescribe epinephrine. Everyone from the primary care physician that on average prescribes one to two prescriptions, to the allergist on average that prescribes 200 plus prescriptions annually. And so as we look at where our focus will be upon launch, it will certainly be in the allergist space.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

We know, and I've worked with allergists for the better part of fifteen years, we know how excited they are about the innovation that ANNAFILM brings to the marketplace. Because they absolutely believe that patients will carry, and if patients carry the product, then they are more likely to use the product as the first signs and symptoms. And because antifilm works so quickly, as you've seen in our data, again, the HCP allergists are very, very excited. Over time, we will look for scale. And you can only look as far as what our competitors have done, as you think about that.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

But again, that allergist is our key target upon launch.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Thanks so much.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Thomas Fatton of Lake Street Capital Markets. Your line is now open.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

Yes, thanks for taking the question. Just perhaps kind of hanging on to the last question that was asked. I'm curious, Sheri, if you guys have done any post nephi launch patient research just to try and better understand, you know, what is that activates that patient? Is it a recommendation from a physician? Are they seeing ads out there?

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

I'm just trying to understand who those patients are that are coming in and actually filling that prescription for a needle free alternative.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

Yeah, it's a good question, and I'm sure we'll hear more from the competition in their call. However, as we've looked at it, and as we've talked to patients and physicians alike, patients want choice, first and foremost. And they want a choice that is easy to carry, easy to use. And so as we think about this, the ability to one, convince the physician that epinephrine is epinephrine is epinephrine, and I think our competition is doing a good job that alternative forms of epinephrine work. And then obviously, from a consumer perspective, moms who are the chief medical officers of the home want a medication, an epinephrine, that their kids will carry.

Sherry Korczynski
Sherry Korczynski
CCO at Aquestive Therapeutics

And so again, as you think about the physicians and the patients and moms, they want a product that the patients will carry and have with them. And so I do believe that all of the consumer education, the direct to consumer that our competition has started, and is doing a great job of, quite frankly, is increasing that awareness. That will only help, as Dan mentioned in his opening comments, of the growth of the rescue market to ultimately prevent those deaths that occur due to anaphylaxis.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets

Great, thank you.

Operator

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Dan Barber for closing remarks.

Daniel Barber
Daniel Barber
CEO, President & Director at Aquestive Therapeutics

Thank you, Marvin. Well, we appreciate everyone joining us this morning. As you heard, we remain excited about where we are, and we're looking forward to continuing to update everyone on our progress in the weeks and months to come. Take care.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Executives
    • Daniel Barber
      Daniel Barber
      CEO, President & Director
    • Ernie Toth
      Ernie Toth
      CFO
    • Carl Kraus
      Carl Kraus
      Chief Medical Officer
    • Sherry Korczynski
      Sherry Korczynski
      CCO
Analysts
    • Brian Korb
      Co-founder & Managing Partner at Astr Partners
    • Mazahir Alimohamed
      Biotech Equity Research at Leerink Partners
    • David Amsellem
      MD & Senior Research Analyst at Piper Sandler Companies
    • Kristen Kluska
      Equity Research Analyst at Cantor Fitzgerald
    • Andreas Argyrides
      ED & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
    • Jason Butler
      MD & Biotechnology Equity Research at JMP Group LLC
    • Daniel Smith
      Equity Research Associate at H.C. Wainwright & Co.
    • Denis Reznik
      Senior Equity Research Associate at Raymond James
    • Thomas Flaten
      Senior Research Analyst at Lake Street Capital Markets
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