Aquestive Therapeutics (NASDAQ:AQST) Q3 2026 Earnings Call

0:00 Good day and thank you for standing by. Welcome to the Q3 2026 Equestive Therapeutics, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 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, Faith Pomeroy Ward from Equestria. Please go ahead.

0:41 Thank you, operator.

0:42 Good morning and welcome to today's call. On today's call, I'm joined by Dan Barber, President and 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 third quarter ended September 30th, 2026 and a business update on recent developments, 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 closed yesterday.

1:32 In addition, a recording of today's call and related supplemental materials will be made available on Equestiv's website within the investor section shortly following the conclusion of this call. To remind you, the Equestiv team will be discussing some non-GAAP financial measures this morning as part of its review of third quarter 2026 results. A description of these measures, along with the reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the Investors section of Equestiv'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 annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 4, 2026 and in its subsequent quarterly reports on Form 10-Q and current reports on Form 8-K.

2:41 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 a questive 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.

3:28 The company assumes no obligation to update its forward-looking statements or outlook or guidance 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.

3:47 Good morning, and thank you for joining us today. This morning, I am pleased to tell you that we continue to execute right on schedule. In March, I told you that we would resubmit our Antifilm Dibute Epinephrine Sublingual Film application I told you that we would refinance our debt before principal payments became due in June, and we did. I told you we expected to have $70 million or more of cash and cash equivalents at year-end, and I'm pleased to tell you that we now expect to end the year with more than $70 million in cash and cash equivalents.

4:39 In fact, as we sit here today, we are right where we expected to be. Our lead asset, Anifilm, is under review with the FDA and has an assigned goal date that is only 132 days away. Or, if you are an investor, since this is our earnings call, only 88 trading days. We are now focused on the next set of deliverables in our execution story. Our organization is ramping up for the US launch of Anifilm following FDA approval, and we are now hiring our district sales managers. We expect to file Anifilm in Canada before the end of the year, and we are on track to file in Europe in the first quarter of next year.

5:30 Our ex-US licensing activities also continue and we expect to have more to say in the months to come. Now, let's talk more about anafilm in the US. Everywhere I go and everyone I talk to in the allergy community can align behind one important concept. When a person is having a severe allergic reaction, the only thing they care about is making it stop as fast as possible. That's it. And that's where we believe anafilm will shine if approved by the FDA. Stopping a severe allergic reaction is a function of many things, including having a rescue product with you, using the rescue product without hesitation, and having your symptoms abate quickly.

6:23 That is why we believe speed is the ultimate differentiator and we will continue to focus on this as we interact with the allergy community. Our presentations at the upcoming American College of Asthma, Allergy and Immunology in Phoenix this month will highlight these views. This is also why I continue to see the opportunity for anafilm as significant. I continue to believe the market will transition from auto-injectors to new and improved technologies like anafilm. The market remains large and growing. We expect the overall U.S. market for epinephrine products measured by total prescriptions to once again grow year over year in 2027, and we see plenty of opportunity for continued market growth in the years to come.

7:17 From a development standpoint, we are answering the FDA's information requests as we receive them and will continue to do so. At this time, We have nothing new to report on the review. In terms of timing, while the FDA has assigned a six-month review period, we remain prepared and hopeful for the possibility of an earlier decision. However, we do not control the FDA's timelines or how they prioritize their workload. Therefore, we are keeping our expectations on receiving its decision by March 16, 2027. In terms of expectations, We recognize that our story in 2027 will be one of execution.

8:03 As we look towards a spring launch of Anisone, if approved by the FDA, I'd like to outline for you how we will judge success in 2027. In other words, what are the green shoots to look for in 2027? First, we are determined to show ongoing progress with payers via both percentage of covered lives and quality of coverage. We will update you as these happen. We have engaged in the pre-approval information exchange or PIE discussions with the top four PDMs in the country along with many downstream plans and will continue to advance productive dialogue as much as possible prior to approval.

8:49 Second, we want to see uptake in the places where we show up. Post-launch We will provide you with a view of our progress among the physicians our sales reps are calling on. This is a place we must show progress. Third, we will track the efficiency of our spending. How many dollars are we spending versus the uptake we see? This will be an important measure as we look to scale our launch quarter by quarter. Now let's briefly talk about Libervin. We are excited to have outlicensed Libervent diazepam buckle film to Econ Pharmaceuticals. We have waited a long time for Libervent to be available to patients, and we expect this to finally come to fruition in 2027, if approved.

9:44 We believe Econ is the right commercial team to launch Libervent, and we look forward to working with them in 2027 and beyond. While Libervent is not central to our growth story, It is an important product for patients and can also be an important cash contributor to the company. Now let's turn to the pipeline. Long term, our goal is to become the leading provider of cutting edge medications for patients who need to control their immune responses. We intend to do this through not only becoming a full fledged commercial organization with deep expertise in allergy Dermatology, and Pulmonology, but also through building a new pipeline of development assets.

10:34 We see 2027 as a pivotal year for our Adreniverse pipeline. In 2027, we would like to provide meaningful clinical data on AQSC-108 for atopic dermatitis, as well as bring additional Adreniverse-driven indications through proof of concept utilizing our library of epinephrine prodrugs. Now that our development team has resubmitted the ANIFILM application in the U.S., we expect to focus more energy on these efforts. So if you look at where we're going, there's a lot to be excited about. We are only a few months away from our FDA goal date for ANIFILM. We are expanding into ex-U.S. territories.

11:22 We have managed our cash tightly and remain on track to fund Anifilm's launch, if approved, and we will have more focus on our pipeline as we move into 2027. With that, I will turn the call over to Ernie.

11:39 Thank you, Dan, and good morning, everyone. By now, you will have seen our third quarter 2026 financial results in the earnings release issued last evening and detailed in our Form 10-Q. as we typically do, we will address most of the detailed discussion during our Q&A. I will focus my remarks on our financial performance, operating expenses, and the discipline capital allocation that supports our next phase of execution. As Dan outlined, we continue to execute against the commitments we made at the beginning of the year. We resubmitted the ANIFILM application before the end of the third quarter.

12:26 We completed deliver event licensing transaction. We refinanced our debt in May before scheduled principal payments under the prior notes would have begun. And through disciplined management of our spending and liquidity, we now expect to end 2026 with more than $70 million in cash and cash equivalents. We believe our existing liquidity together with potential access to additional capital under the RTW and Oaktree agreements if Anifilm is approved and other applicable conditions are satisfied positions us to support launch readiness and initial commercialization activities for Anifilm if approved while continuing to advance our broadband pipeline.

13:16 Before turning to the quarter, I want to briefly highlight the financial aspects of our recently announced LibraVant transaction with Etan Pharmaceuticals. Under the agreement, Etan received exclusive U.S. rights to commercialize LibraVant, subject to applicable regulatory approvals. We received a $10 million upfront payment and are eligible to receive up to an additional $47.5 million in contingent regulatory and commercial milestone payments. We will also receive a mid-teens royalty on annual U.S. net sales of LiberBand. Importantly, Equestid will remain the exclusive manufacturer and supplier of LiberBand to Eton under a long-term supply agreement.

14:11 So, in addition to the upfront payment, potential milestones, and royalties, the transaction preserves an ongoing manufacturing relationship around the product. We believe this is a capital efficient structure for Equestis. It places responsibility for U.S. commercialization with Eton while allowing us to participate in the product's future value and remain focused on our primary commercial priority, the potential launch of Anifilm. Now let me begin with revenue. Total revenue was $7.6 million in the third quarter of 2026 compared with $12.8 million in the third quarter of 2025.

14:59 This decrease was primarily driven by the quarterly fluctuation of Suboxone product orders. Manufacturer and supplier revenue was $6.7 million in the third quarter compared with $11.5 million in the prior year period. This primarily reflects lower Suboxone revenue Partially offset by higher on GEEF revenue. License and royalty revenue was $0.8 million in the third quarter compared to $1 million in the third quarter of 2025, primarily reflecting lower royalty revenue received during the period. Co-development and research fees were approximately $0.1 million compared with approximately $0.3 million in the prior period.

15:53 For the first nine months of 2026, total revenue increased 14% to $35.8 million, compared with $31.5 million for the same period of 2025. This increase was primarily driven by higher license and royalty revenue, including $5 million of DEVRA-related royalty revenue, partially offset by lower manufacturer and supplier revenue, and lower co-development and research fees. Manufacturer and supplier revenue for the first nine months was $27.4 million compared with $28.2 million in the prior year period. License and royalty revenue increased to $7.5 million from $2.7 million primarily due to royalty revenue from Zevra.

16:48 Turning to operating expenses, Our results reflect the deliberate choices we have made as we prepare for a potential antifilm launch while continuing to manage our overall spending carefully. Research and development expenses were $4.3 million in the third quarter, compared with $4.5 million in the third quarter of 2025. This decrease primarily reflects lower share-based compensation partially offset by higher clinical trial costs associated with the human factors validation study and the pharmacokinetic study completed for the antifilm NDA resubmission.

17:34 For the first nine months of 2026, research and development expenses decreased $12.4 million from $14 million in the prior year period. This decrease primarily reflects lower product research expenses associated with the ANIFILM program and lower share-based compensation partially offset by higher personnel costs. Selling, general, and administrative expenses were $14.2 million in the third quarter compared with $15.3 million in the prior year period. The year-over-year decrease primarily reflects approximately $1.5 million of lower legal fees, approximately $1.4 million of lower commercial spending, and approximately $.6 million of lower antifoam-related regulatory expenses.

18:32 These decreases were partially offset by higher personnel costs, share-based compensation, and consulting and outside services expenses. For the first nine months of 2026, selling general and administrative expenses decreased to $39.2 million from $47 million in the first nine months of 2025. The decrease primarily reflects approximately $6.1 million of lower commercial spending, the absence of the $4.3 million one-time antifilm PDUFA fee incurred in the prior year period, Approximately $2.8 million of lower legal fees, approximately $1.5 million of lower regulatory and licensing fees related to liver bands, and approximately $1 million of lower antifilm-related regulatory expenses.

19:30 These decreases were partially offset by higher personnel costs, severance costs, share-based compensation, and consulting and outside services expenses. Turning to the bottom line, our net loss for the third quarter of 2026 was $16.5 million or 13 cents per basic and diluted share. This compares with a net loss of $15.4 million or 14 cents per basic and diluted share in the third quarter of 2025. For the first nine months of 2026, our net loss was $47.4 million for $0.38 per basic and diluted share, compared with a net loss of $51.9 million, or $0.51 per basic and diluted share for the same period in 2025.

20:23 Just a reminder, the 2026 year-to-date results include a one-time loss on the extinguishment of debt of $11.7 million related to the repayment of our 13.5% note. Excluding that one-time item, our net loss for the first nine months of 2026 was $35.7 million. Non-GAAP adjusted EBITDA loss was $12.2 million in the third quarter of 2026, compared with a non-GAAP adjusted EBITDA loss of $8.6 million in the third quarter of 2025. For the first nine months of 2026, Non-GAAP-adjusted EBITDA loss narrowed to $19.2 million compared with a non-GAAP-adjusted EBITDA loss of $35.5 million in the prior year period.

21:20 Please refer to the reconciliation of net loss to non-GAAP-adjusted EBITDA loss included in our earnings release. Let me finish with liquidity and capital allocation. We had $90.3 million in cash and cash equivalents at September 30, 2026. This amount does not include the $10 million upfront license fee received from ETHON in October in connection with the Riverbank transaction. As Dan noted, we have managed our cash tightly and expect to finish 2026 with more than $70 million in cash and cash equivalents. This expectation includes the $10 million Eton upfront license fee received in October and does not assume receipt of a contingent RTW or Oak Tree funding.

22:17 If Anifilm receives FDA approval by the applicable deadline and we satisfy the other conditions under the relevant agreements, we expect to have access to $75 million under the RTW strategic funding agreement and an additional $20 million under the Oak Tree Term Loan Facility. Together with our existing liquidity, we believe these sources would support launch preparation and initial commercialization activities for antifilm, if approved, while allowing selective investment in our development pipeline. We are maintaining our full year 2026 financial guidance. For 2026, The company continues to expect total revenue of $46 million to $50 million and non-GAAP-adjusted EBITDA loss of $35 million to $30 million.

23:16 Looking ahead, our capital allocation priorities are clear. First, we will fund the activities necessary to maintain launch readiness and prepare for the potential U.S. commercialization of Antifilm, if approved. Second, we will continue to support the medical, regulatory, market access, and payer work needed to prepare for commercialization following potential approval and to advance our regulatory strategy outside the United States. Third, we will invest selectively in the Adreniverse pipeline with an emphasis on the programs that we believe have the potential to generate meaningful clinical data and create long-term value.

24:03 And finally, we will continue to manage our liquidity and capital carefully as we advance these priorities. With that, I will now turn the call back to the operator to open the line for questions. Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Roana Ruiz of Lyric Partners. Your line is now open.

24:45 Hey, everyone. Good morning. So a couple for me. First is with the upcoming PDUFA for Anifilm, could you give us an update of what commercial initiatives you plan to use out of the gate and generally what the overall split could be between digital advertising, prescriber targeting, and other field rep initiatives?

25:07 Sure. Rowan, did you have a second question or that was the question you wanted to put out?

25:12 Oh. That was the first one. The second one, I did have a question about pre-approval info exchange with the PBMs. How much does that set up coverage discussions, and can you give us a little color around that?

25:23 Sure. Absolutely. Well, first, good morning, and appreciate that you instantly went to, of course, where our focus is on the commercial launch. Look, we feel great right now. We feel like we've managed our cash. We've got a strong cash position. We've maintained guidance. We're under review. Sherry and her team are preparing for launch. So you're absolutely right that the commercial initiatives are a place of focus. And Sherry's right here with me, and I'll let her walk you through the digital advertising and sales thoughts she has.

25:58 Good morning, Ruana. Thanks again for the question. We're so excited here. When you think about it, you know, never has a product offered what Anafilm will offer to both the allergist community as well as to caregivers and patients. It's truly a 360-degree approach to anaphylaxis management that has never been done before. and so it is critically important for us as we are completing the build of our senior staff, our district sales managers, our sales training, our supply chain is all ready to go and as you know it's based in the U.S. We are working diligently to prepare for the Salesforce and those non-personal promotion efforts. While I'm not going to get into the details as far as percent of split as far as spend, as we've mentioned before, the allergists are key, and we will have approximately 75 representatives calling on around 8,000 customers. These are the top tier allergists, some pediatricians, and otolaryngologists.

27:09 So we know and absolutely believe that having surround sound with those key customer targets is very, very important. So not only will our sales representatives be addressing, my medical colleagues are out at conferences and they will continue to be out with the allergists to continue to drive our message around our clinical efficacy as well as the other key benefits of the product. It's so easy to carry, it's very easy to use. So you will see a nice split, Rohana, amongst the marketing initiatives and those Salesforce initiatives. If the deep question is really, are we going to be launching into TV and things like that, there will be a time and a place for major DTC efforts.

28:01 As Dan has mentioned, we plan to be efficient with our spend. As we see those opportunities, we'll begin to invest further.

28:10 So let me, Rwanda, take the second question, which was around the pre-approval PBM interactions. I believe your question was what's the extent of what you can do there. These are really important engagements. And tying into what Sherry just outlined, we feel very strongly that the opportunity in this space is to bring healthcare providers and patients back to the clinical data. The auto-injector has been the de facto leader for 45 years because it's the only thing out there, not because the data is the reason for that product. We have an opportunity in our pre-approval interactions with the PBMs to show them our data. And I'm very fortunate to work with a great team, including Melina Cioffi and Matt Greenhawt, who are here with me this morning, who will walk that clinical data with our PBMs and really show them why we think we're differentiated.

29:09 So we understand that the The dance to get to contracting is a difficult one for any pharmaceutical company. However, we do believe that that clinical data can lead the way for us as we move forward.

29:31 Sounds great. Thanks. Thank you. Our next question comes from the line of Kristen Kluska of Cantor. Your line is now open.

29:44 Hi, good morning everybody and congrats on the resubmission acceptance. Two questions for me. The first is when you received that acceptance, did you get any word or comments about whether the FDA would kind of be reviewing everything from scratch or really the key focus is on the new data and information that you've shared since? And then the second question is, I'm just curious, this past year has given you more time and you've obviously collected more data as a company. What would you say has changed the most in terms of your expectations on what this launch or product could look like versus where you were at a year before you had done these additional studies and work? Thanks very much.

30:26 Thanks, Kristen. So in terms of the acceptance, I'll turn it over to Melina in a second and she can walk you through her thoughts I will say this with the FDA. We've obviously been, we think appropriately vocal is the way I would put it, that this is a pretty limited package. And we believe there's an opportunity, especially with where the FDA is publicly talking about speed of review and transparency and all of the things they want to do. We do believe there's an opportunity for a faster review here. We don't control that, so that's completely up to them. But I want to make sure everyone knows that we are advocating for that and doing it appropriately, we believe. But I'll let Melina give you her thoughts.

31:12 Sure. Good morning, Kristen. So in terms of the focus of the review, in the context of a resubmission, the focus is simply the complete response items that were outlined in the complete response letter. So when we hear from the agency in terms of the acceptance of the submission, they are informing us that our response is complete to facilitate their review. And the focus of said review will be strictly or intended to be strictly on the resubmission scope. So I hope that gives a little bit of clarity in terms of the scope of the data that will be reviewed consistent with what Dan has mentioned.

31:59 Thanks Melina. So I will let Sherry give you some thoughts on learnings in a second here but I just want to give in my mind what I think is the most important learning and I'll go back to Matt Greenhawt joining us in February and I don't know that this is due necessarily to having to deal with the packaging CRL that we're having to deal with, but more from what's important to allergists. And I think Matt has really championed in our company that the clinical data we have is really compelling. And so that's why you've heard us, if you go back through what we talk about in these calls over the last four to six quarters, we've really moved from this idea of, okay, we have interesting PK comparison data Let's really talk about the pharmacodynamic data and what it means to patients.

32:53 And you heard in my prepared remarks, we really do understand and believe the only thing a patient cares about is that their severe allergic reaction stops. And that is about the pharmacodynamic measures that we have, not necessarily PK comparisons. I know Sherry has a lot of thoughts as well, so I'll let her add on hers.

33:15 No, just to really add on to Dan is what has changed the most in the last year, Kristen? What I would say is with bringing Matt on and really like having great deep understanding of this PD data, we have so much confidence in the differentiation Anafilm has for patients and caregivers. And so what I would say is we have to lean into the importance of trust and confidence. And so one of the key learnings that we've had is, you know, do patients feel that they have to carry multiple devices? Some do. Are physicians really confident in the data of the newer products? And so for us, our ability to lean into the data, into having physicians and caregivers, patients alike, trust and be confident that anafilm is going to work. in an emergency rescue situation.

34:16 That is first and foremost. Look, the fact that we can carry it on the back of our phones, that it is very durable, that it's easy to use, that's all icing on the cake. We really truly believe that Amafilm delivers confidence. It's carried differently. So I would say overall, that is our biggest learning in the last year, Kristen.

34:39 Thanks very much, everyone.

34:44 Thank you. Our next question comes from the line of David Amsellem of Piper Sandler. Your line is now open.

34:52 Hey, thanks. So two for me. First, in terms of the commercial launch and also your access initiatives, can you talk about what you're going to do differently relative to ARS and its experience with NEFI, both in terms of physician targeting, promotion, and access strategy. Love to hear how you're taking learnings from their experience and applying it to Anafilm. So that's number one. And then secondly, on the Adreniverse platform, I know that you've talked about being judicious about spend on the programs here, but as you think about Atopic Derm and that development program, Can you give us a little insight into what other potential indications you can see yourself moving into for the platform and what you're going to prioritize over time beyond AD? Thanks.

35:58 Thanks, David. Great to hear your voice. So I would say, and I'm going to hand it over to Sherry in a second here to talk about targeting and promotion in particular. I would say the focus as a global comment, the focus that we'll bring of where the place to start our story in this community is probably the number one thing that compared to anyone who's come out in the past years, you'll see from us. But I'll let Sherry give you her thoughts.

36:35 Hi, David. Yes, thanks so much for the questions. As it relates to, you know, we've discussed a lot about what our learnings over time from the device, the nasal device launch. What I will share again is our strategy is around depth in the allergist and high prescribing epinephrine writers community. and so we are going with a very targeted approach at about 8,000 to 8,500 key targets and our sales team will be very focused on all the execution. Seeing the right targets with the right frequency and providing with them with the right resources in order for them to have the confidence that Anafilm will work in a rescue situation and a patient, quite frankly, will have it on them in the event that such a situation occurs.

37:29 So I do see that as our launch as compared to the other launch, that is a difference. From a promotion perspective, We talk about, again, our value proposition is not based around just one thing. It is not a singular value prop. Our value prop is focused on efficacy to drive trust and confidence for the prescriber and their patients and caregivers. It's around the ease of caring and always having with you should an allergic reaction occur. and then the ease of use and durability of the product. So we do believe from a promotion perspective that all of our promotional materials, our NPP, the work that we're doing currently in marketing for the reps to have in promotion are all going to be tied around this value proposition. and as it relates to the payers, as Dan mentioned, look, we want as many patients to have access to Anafilm and it's a top priority for us. Obviously, rapid payer coverage is key.

38:43 Managing the friction that our HCP offices is very important and so we continue to have very robust discussions with the payers and the PBNs who continue to tell us their significant interest in Anafilm. It's important to us to look at this holistically and set up a best-in-class hub and patient support service strategy. And all of that work, David, is underway. We have the luxury, if you would say, of time. And so our team has picked apart every piece of this launch and so that we are very, very well prepared when the approval comes.

39:24 So I just, David, want to circle a little bit more on the market access piece of this. And I'll say something that perhaps the cynics in our industry wouldn't buy into, but I do believe from my interactions with the PBMs, I do believe they want to allow innovative products to be in the hands of the patients that they support from a payer perspective. They do want that. but they have a job to do. They have something that they're trying to manage and that's the costs of the medical and healthcare community. So while we may not agree on exactly how to approach any particular product, when you're going to a PDM and you're saying you have an innovation and you're asking for a premium to a generic auto-injector, you have to tell them why. You have to tell them why your product should be in that category and that again is where we really believe the clinical data and talking about how that clinical data manifests itself in the community is an important factor in our market access story.

40:33 So we'll continue those conversations and look forward to seeing how they unfold.

40:43 And then the Adrenaverse question.

40:47 Thank you, David. I even wrote it down and I forgot to address it, so my apologies. Yeah, we're really excited about the long-term potential of the epinephrine platform. It's been frustrating, quite frankly, especially with having to deal with the CRL, that we haven't been able to more quickly focus on the Adrenoverse while we get anafilm through the regulatory process. The atopic derm is an entry point in our mind. As you know, we started with alopecia areata, but when you look at dermatology, atopic derm is a typical spot with a new mechanism of action or new way of approaching something that you get into a space.

41:35 So we will, again, continue to show with our atopic derm product that in 2027 we can show real All right, thank you. Thank you. Our next question comes from the line of Francois Brisebois of LifeSci Capital. The line is now open.

42:21 Hi, thanks for all the details here on the questions. I just wanted to actually go into more detail, if that's okay, on a prior question because when you talk about what the learnings of the last year and how to differentiate, it seems like there's a strong emphasis now from the PK to now PD side of things. Can you explain a little bit why you think that is more important and how, you know, this is kind of a three-part question. Like, why do you think the PD is so important and so relevant? And then two, is that thought process appreciated? What's the evolution of the appreciation from the medical community, especially with Matt going around and speaking to people about this? Has that evolved for them in the past year as well? And yeah, I guess just to start with that's fine.

43:10 Sure. Well, and I'm going to pass it over to Matt, but I'll just say globally, I really do think that the simplest way to describe the concept is how fast can you stop a severe allergic reaction? And PD is obviously the first way to show that, but I'll let Matt pick it up from there. Good morning.

43:29 Yeah, I mean, when You think about why do you give somebody epinephrine? They're having a reaction. They're starting to go into shock, showing other signs of hemodynamic distress. This is what epinephrine does. It abruptly raises your blood pressure and heart rate. And the speed of that response makes all the difference. As a clinician, that's really all I cared about every time I gave epinephrine to a patient. The blood levels are great. It's a regulatory point. but it really has limited clinical translation and what we're seeing and what we believe we have with our product is something that works fast and the resulting increases in heart rate and blood pressure are strong and this difference you know is time is of the essence and you really you want that to kick in as fast and as high as possible that's how you get somebody out of out of danger. So I'm really excited.

44:29 We have some data that we're going to present next week at the college meeting that better translates some of this from our OASIS study to show sort of really where that breakdown is of how if you focus too much on PK, you're really missing most of the story. In terms of resonation in the field, this resonates well. This is, again, every clinician, this is what you want to hear, not what the PK is, but how fast is this going to work? How fast is my patient going to respond? You know, that's a very tangible message. It's very approachable. I think the PK probably has been the harder thing for most of us to wrap our heads around for years, and how long I've consulted and worked with the company, going back to 2018, you know, the T-Max story is great.

45:16 And yes, we do. PK, we certainly have great numbers on, you know, our T-Max is very fast and our C-Max is high. But again, that's not what really matters to the patient. So I think we've been able to flip that message. And either because of me or in spite of me, I think people are responding to it. And again, you know, this was my area of expertise for years. And to hear it from me, I think, you know, with the work that I've done in anaphylaxis. I think hopefully it's helping. We'll see.

45:48 That's great. That's super helpful. Can you just remind us how you compare to others on the PD side?

45:57 Sure. Our TE Max, which is the timing of the peak of the heart rate and blood pressure, is fast. Depending on the study, we're ranging between about five to eight minutes, depending on the blood pressure parameter, depending on the study, and then the heart rate response, eight to 11 minutes. If you look in our 301 study, our 206 study, for the comparators that we looked at, the earliest is a heart rate peak coming in at around 11 minutes, and everything else is pushed out past 19 minutes.

46:34 Understood. Thank you. Thank you. Thank you. Our next question comes from the line of Mazi Alamuhammed of Oppenheimer. Your line is now open.

46:51 Hi, thanks for taking our question.

46:53 This is Michael on for Mazi. First question is, could you share anything about the pricing relative to other auto injectors and Nessie and your expectations on formulary access in the first year? And would you be offering like cash, pay, or copay programs?

47:14 Sure. Thank you, Michael. So look, and this will be similar to what you heard me say in the August earnings call. We're obviously spending a lot of time on the market access piece of our launch, engaging in the allowable pre-approval interactions in terms of how we're going to price the product. That is the one piece we're going to keep to ourselves for right now. I think there are obvious dynamics in the marketplace that people can assess and come to their own conclusion on in terms of expectations on formulary. Look, any drug that is going to be launched, there are a variety of PBMs that need to believe in your story and you need to have arrangements and ability to contract with them, and we're going through that process.

48:08 As Sherry outlined before, when we get into 2027, how we're able to show progress on that front will be an important thing we bring to this forum. In terms of the tools we'll use, Sherry and her team, of course we're going to have the typical tools for patients whether it is as Sherry mentioned having a hub or it's allowing people to use copay cards things like that will of course be in our toolkit the specifics and which ones we'll use and not use we're not going to outline today but I would say there's just typical things you do in a launch that you'll see us do and I don't think that will be surprising to people.

49:02 Thank you. Our next question comes from the line of Raghuram Selvaraju of HC Wainwright. Your line is open.

49:12 Thanks very much for taking our questions. Firstly, with respect to anafilm, I was just wondering if maybe Sherry could comment on which specialist prescriber subpopulation is likely to be the most receptive, kind of the earliest group of adopters, if you will, among the discrete groups of specialist prescribers that she mentioned in her prepared remarks. I also wanted to ask if the company could comment on the anticipated commercial receptivity for Libervent, which obviously is likely to be launched in the hands of your new partner Eaton. But I wanted to see if you could comment perhaps on the degree to which the market is likely to be receptive to Libervent, in particular in the context of the other formulations and routes of administration for diazepam within the target indications for which Libervent is expected to be labeled. Lastly, if you could comment on the degree to which you expect the commercial presence of Anafilm and regulatory familiarity with the Anafilm regulatory package to potentially provide you with any advantages going forward as you seek to develop and optimize the value of the Adreniverse platform. Thank you.

50:27 Sure. Thanks, Ram. I'll let Sherry first start on the prescriber piece.

50:32 Hey, Ron. Thank you so much for the question. As we stated previously, we are focused on the allergist community first and foremost. We will be calling on approximately 8,000 physicians with our 75 or so reps. Again, predominantly the allergists as they are the highest prescribers. And then from there, there are also pediatricians and otolaryngologists, ENTs, that are high prescribers of epinephrine. Again, our launch is very focused. It is a big, big market. However, we, with our team, will be focused on that community.

51:14 Thanks, Sherry. So from a liver vent perspective, and Ram, you and I have known each other a long time. We've talked about liver vent for a number of years. This is a product that we feel very attached to here at Equestiv. So we think from a patient perspective, it's an important product. The product, as you know, when approved will be labeled for seizure clusters in the epilepsy space. This is a population that is in need of good solutions and solutions that will help them. So we're very excited. Thank you for joining us today. put product into patients' hands in an effective way.

52:26 We really like that. And I also like their culture. I like that they put patients at the center of what they're doing. And I think that bodes well with our culture. So we're very excited to see how that launch unfolds once approved in 2027. From an Adreniverse perspective, your point is well taken. There's no doubt that as Melina and Matt and the team work through the FDA interactions, as well as Melina, who's championing the ex-US interactions. We learn more and more about epinephrine prodrugs and what the possibilities are. also we're making the regulatory bodies more comfortable with the pro-drug approach so I definitely would agree that as time goes on the familiarity with that platform will only help us as we as we spread into other indications.

53:32 Thank you. As a reminder to ask a question you will need to press star 1 1 on your telephone Our next question comes from the line of Thomas Flayton of Lake Street Capital Markets. Your line is now open.

53:48 Hey, good morning, guys. Thanks for taking the questions. Just to follow up on a previous question, Sherry, with respect to early adopters, how did you weight NEFI prescribing in arriving at that target list of 8,000 to 8,500 prescribers? And then secondly for Dan,

54:05 Has FDA communicated anything to you about a pre-approval inspection of your manufacturing facility? Thanks.

54:15 Thank you so much for the question. Obviously, with the nasal device launch about two years ago at this time, it is a component of how we looked at the targeting for our sales representatives. The larger component is obviously the size, the amount of epinephrine that a physician prescribes on an annual basis. But of course, we did look at it and make considerations.

54:45 Thomas, before I pass it over to Melina to talk about a potential PAI, just adding on to Sherry's thoughts, one thing I think that sometimes gets lost in the sauce in this space We've done a lot of survey work, and I'm sure the other branded products in this space have as well. None of the surveys do we get information back from patients saying, we love autoinjectors, we want to keep them. So there is a big opportunity here, and we believe in that opportunity even more today than we did a year ago. And when I watch Sherry and her team really think about how do we bring healthcare providers and patients into a world where they use a product like anti-film, these more innovative products, I think the position we have is compelling. It's going to take time, but the opportunity is there.

55:35 But I'll let Melina talk about the PAI question.

55:39 Melina Cioffi Sure. So in terms of inspection activity, we did go through first round, the 10-month review, interactions with the Inspection Group at FDA. And the focus was certainly on more of the routine clinical sites, which I recall us communicating previously. Here, there's a six-month review timeline. We know that the inspection activity is still possible, particularly from a clinical site perspective. When it comes to the manufacturing plans, as you know, we have a US-based manufacturing facility is supported over the years, not only products that are under review by the U.S. FDA, but certainly globally as well.

56:28 We are well prepared for when and if the agency wants to come to our manufacturing site during this review.

56:37 And I'll just add on to Melina's point. Just remember, Thomas, from a manufacturing perspective, our base business remains steady and strong. In fact, on a year-to-date basis, Suboxone is actually up. It is a declining product over time, but year over year, on a year-to-date basis, it's actually up. Undeep is growing nicely, and we'll have Libervent coming into the plant as well, along with Anifilm.

57:00 So that part of our business remains important and strong. 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.

57:22 Thanks, Stephen. Thank you to everyone for joining us this morning. As you just heard, we continue to gain momentum as we rapidly approach our March 16th action date for Anifilm. As Sherry outlined and Matt as well, the market opportunity remains compelling. We have the financing in place for our launch. and our base business remains stable. So we look forward to keeping you updated on our launch progress over the next few months. And with that, we will close today's call. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.