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spk01: Good morning and welcome to the Equestria Therapeutics fourth quarter and full year 2021 conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then one on your touchstone telephone. If anyone should require assistance during the conference, please press star then zero to reach an operator. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson of Westwick Investor Relations. You may begin.
spk04: Thank you, Operator. Good morning and welcome to today's call. On today's call, I am joined by Keith Kendall, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the fourth quarter and full year, 2021, followed by a Q&A session. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call will be made available on Equestive's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestive team will be discussing some non-GAAP financial measures this morning as part of its review of fourth quarter and full year 2021 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 Equestria'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 factor section. and in other sections included in our annual report on Form 10-K filed with the Securities Exchange Commission on March 8, 2022, and in our quarterly reports on Form 10-Q and current reports on Form 8-K filed with the SEC. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and insurgencies. with respect to the company's business and development, regulatory approval, and commercialization of its products and other matters related to operations. The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty or clarity. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as 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. The company assumes no obligation to update its forward-looking statement after the date of this conference call, whether as a result of new information, future events, or otherwise accept as required under applicable law. With that, I will now turn the line over to Keith.
spk09: Thank you, Bennett, and thank you to everyone on the call for joining us this morning. In our remarks today, Ernie and I will be discussing recent developments in our business during the fourth quarter of 2021 and through early March. As always, Ernie and I will be joined by additional members of the Equestrian Leadership Team during the Q&A session afterward. We remain as a company keenly focused on the two most important value drivers for Equestiv, Libervant and AQST109. We continue to engage with the FDA regarding the ongoing review of the NDA for Libervant. Related to our epinephrine program, we recently reported positive top line data from part one of the epifast crossover study for AQST 109 and the commencement of part two of that study. In late February, we received clearance from the FDA for the US IND for AQST 109. Additionally, our core business outperformed our expectations in 2021. As you saw in our release last night, and as Ernie will discuss more fully in a few minutes, Our full year 2021 revenue came in above the updated guidance provided in November, and our non-GAAP-adjusted EBITDA loss came in better than expected. Let's start with Libervant. On December 20, 2021, we received notification from the FDA that it would not be ready to act by the PDUFA date of December 23rd. for the company's NDA for Libervant diazepam buccal film. The agency was unable to provide an estimate of the timing of an expected action. We were surprised by the FDA's unexpected notice that they were unable to provide a decision by the PDUFA date. The agency's review division had finished its review and indicated that no additional information was necessary from the company. We had previously completed the pre-notice requirements, such as labeling negotiations, additional information requests, and post-marketing adverse drug experience reporting, or PETA, audit. Since that notice in December, we've interacted with the agency, who in their most recent correspondence in February stated the following two points, and I quote, the agency is continuing to consider whether the orphan drug exclusivity identified for another diazepam product affects the approvability of your application. Additionally, they went on to say, and I quote again, we're continuing to consider the information and arguments submitted by and on behalf of Equestiv. At this time, we cannot provide a specific update regarding timelines or an anticipated action date, close quotes. The company continues to believe that LibraVant is an approvable product for safety and efficacy, as evidenced by the completion of the pre-notice requirements I discussed a minute ago. With respect to the FDA granting market access, given the orphan drug exclusivity issue, we continue to believe we've made a compelling case that LibraVant represents a clinically superior product to their previous rectal and nasal products. based on LibraVant providing a major contribution to patient care, as outlined in the agency's guidelines. LibraVant, if granted market access, has the potential to transform the lives of refractory epilepsy patients seeking a non-invasive and innovative product for the management of seizure clusters. This patient population remains underserved, with more patients over the last 12 months across all age groups, continuing to utilize the diazepam rectal gel product versus the diazepam nasal products, despite good payer coverage. The vast majority of potential patients are still not accessing either of these difficult to interact with alternatives. Providing a preferred method of delivery, an oral product, that can be used where it's needed, when it's needed, and in a preferred form is a potential highly differentiated treatment option for this patient population. Obviously, we believe LiberVant, utilizing our farm film technology, provides a preferred oral product that will be a meaningful improvement in treatment options available for these patients. Equestiv continues to prepare to launch this important product for epilepsy patients if granted market access by the FDA. Let's move on to epinephrine. Our next key value driver and priority is advancing our epinephrine product candidate for severe allergic reactions, including anaphylaxis, AQST109. AQUESTIV is advancing the clinical development of AQST109, the first and only orally delivered epinephrine product candidate to demonstrate results comparable to autoinjectors, such as EpiPen and AviQ. that are the current standard of care for the emergency treatment of severe allergic reactions. As we had committed in our last call, we announced in late February that the FDA has provided clearance for Equestiv's IND allowing clinical development in the United States. This is a necessary step to eventually moving the project toward an NDA filing expected in late 23 or early 24. As a reminder, the agency previously confirmed the 505 regulatory approval path as appropriate for AQST109. Additionally, we announced in late February positive top line results from part one of our EpiFast study evaluating AQST109. The product candidate continues to show rapid absorption and conversion of the prodrug to epinephrine in subjects achieving a median time to maximum concentration, or Tmax, of 13 1⁄2 minutes. We are obviously pleased with these results and have already begun part two of the study and expect to report top-line data before the end of the second quarter. We're excited that we've again shown pharmacokinetic results that demonstrate delivery of epinephrine with the absorption and conversion speed necessary for a rescue product of this kind. with a significant part of this patient population not having this medicine where they need it, when they need it, for a variety of reasons, including needle phobia, convenience, delayed or incorrect administration. AQST 109 represents a meaningful improvement in this group of patients' and caregivers' lives. We're looking forward to the continued development of AQST 109 and, as we've indicated previously, We expect to move forward with the manufacture of registration batches and to commence pivotal trials in the U.S. under the IMB before the end of 2022. Finally, our core business. Our core business continued to contribute new opportunities as well as cash in 2021. Our Suboxone business remains resilient and continues to contribute at a higher level than expected. Simpazan continued to perform and has now grown 12 straight quarters since its approval and launch. These will all contribute revenue and cash in 2022 and beyond. And as we just announced, we've signed a new licensing agreement with a China-based pharmaceutical company, Heisco, for the development, manufacture, and commercialization of Exervan in China. The deal contributes $7 million of upfront cash, manufacturing revenue with Equestiv as the sole supplier to Heisco, and double-digit royalties once the product is launched in China. In conclusion, as we progress through the first quarter of 2022, we're focused on advancing our proprietary products. We remain in close contact with the FDA regarding the application for LibriVamp, The FDA is continuing to evaluate the impact of orphan drug exclusivity on our NDA. We believe that LibriVant is an approvable product for safety and efficacy as evidenced by the completion of pre-notice requirements that I discussed earlier. We're prepared to launch immediately if granted U.S. market access. AQSD has advanced into Part 2, of the EpiFast study after we reported positive results from part one last month. Concurrently, the FDA's provided clearance for the IND, and we're on track to commence pivotal trials later this year. And finally, again, our ongoing business continues to perform well, and we look forward to delivering the strong results outlined in our release, which Ernie will discuss shortly.
spk08: Thank you, Keith, and good morning, everyone. By now, you will have seen our financial results in our 10-K and earnings release that were filed last evening. As we typically do, we will address most of the discussion related to the fourth quarter 2021 results in the Q&A. Complementing our business focus on the priorities of Libervant and AQST 109 that Keith just discussed, has been a strong financial focus in 2021, and admittedly, some complexity that I will attempt to clarify. First, during the fourth quarter, as we previously announced, we worked closely with our lenders to provide additional optionality to the company by extending the time that we have access to an additional $30 million available within our existing debt facility from December 2021 until June 2022 if we choose to fully fund the launch of LiberBand if granted market access. Additionally, we reached agreement with our lenders to amend the principal amortization schedule of our debt. As a result, during the fourth quarter of 2021, we recognized a one-time non-cash loss and extinguishment of debt of $13.8 million, for fees and expenses related to the fourth supplemental indenture that was executed on October 7, 2021. This agreement with our lenders amended the principal amortization schedule to free up over $10 million of capital between the execution date and year-end 2022 for a $2.7 million fee payable in four quarterly installments beginning May 15, 2022. This one-time non-cash loss and extinguishment of debt had an impact on EPS of $0.34 loss per share in the fourth quarter and of $0.36 loss per share for the full year based on the weighted average number of shares outstanding for the three and 12 months ended December 31, 2021. Also, the full-year effect of the accounting for the Kenmoby royalty monetization transaction was $12.4 million in interest expense related to the sale of future revenue, resulting in an EPS impact of $0.33 loss per share. As a reminder, this accounting does not and will never represent a cash obligation or payment by the company. Overall, we saw continued strong performance from our existing business, including new opportunities generated with HISCO, as well as continued contribution of cash. While Suboxone is a legacy product for us, it remains a significant part of our near-term revenue outlook. This product continued to perform well and exceed expectations in 2021. Our revenue guidance for 2022 considers that some level of erosion of market share will continue in the future. As Keith mentioned previously, Simpazan generated sequential quarterly revenue growth for the 12th straight quarter. Our trends in wholesaler shipments of Simpazan to retail pharmacies and growth in new and repeat prescribers represent a very solid 77% increase when you compare the fourth quarter 2021 with the same period last year. We anticipate continued growth in 2022. In addition to the continued strong business development activities, we continued our prudent expense management and diligently managing our cash position in order to not only improve results, but also extend our capital horizon. As of December 31st, 2021, cash and cash equivalents were $28 million. During the fourth quarter of 2021, we received $5.2 million in net proceeds from our at-the-market or ATM facility. For the year ended December 31, 2021, we received $29.8 million in net proceeds from our ATM facility. We expect that our existing cash and cash equivalents, revenue from our ongoing manufacturing operations and commercialized products, continuing business development activities, and prudent expense management actions combined with ATM activity, will provide adequate funds and meet expected cash requirements for the next 12 months. While we have not been accessing the ATM recently, it remains an important tool to support the capital needs of the company. Separately, we expect the potential launch of LiberVant, if granted U.S. market access by the FDA, to be funded by the additional $30 million of contingent funds available as part of the existing 12.5% notes. Looking forward, we expect royalty streams from license agreements to contribute to our future revenue. These royalty streams include Aztarus, which was launched in 2021 by Corium under license from ChemPharm, Suboxone in markets outside of the U.S. with Indivior, Exervant in the U.S. with Mitsubishi Tanabe, in the EU with Zambon, and is recently announced in China with Heisco, as well as the launch of Undancitron by Hypera in Brazil following their recent approval. In addition to contributing revenue and cash to the company, these assets also represent potential opportunities to monetize streams of royalties, as we did for the Kynobi royalties. As outlined in the press release issued last night after market closed, we issued our full year 2022 financial guidance. CIFASAN growth, the continued strong performance of our manufacturing and supply operations, and our other ongoing business activities are expected to provide strong operating results during 2022. Spending and R&D is projected to accelerate as we continue development of AQST 109 during 2022. Moreover, We have taken steps to continue to strengthen our capital position. As such, we are providing our full-year financial expectations as follows. Total revenues of approximately $42 million to $47 million. Non-GAAP adjusted gross margin of approximately 70% to 75%. And non-GAAP adjusted EBITDA loss of approximately $51 million to $58 million. It is worth reiterating that this 2022 financial guidance does not include any revenues from LiberBand and will not until U.S. market access is certain and the launch is underway. In summary, our 2022 guidance for full-year non-GAAP-adjusted EBITDA loss reflects a lower projected revenue base from Suboxone, partially offset by steady growth in Simpazan, and significant additional focused R&D investments related to the advancement of AQST 109. At the same time, we will continue to prudently manage our costs across our business to be as capital efficient as possible. With that, I will now turn the line back to the operator to open the line for questions.
spk01: As a reminder, to ask a question, please press star then 1. If your question hasn't answered and you wish to remove yourself in the queue, press the pound key. Our first question comes from Gary Nachman with BMO Capital Markets. Your line is open.
spk06: Hi. Good morning, guys. Regarding FDA's communication on LibraVan, so we know it's the ODE that's holding it up, but how much back and forth have you had with them, Keith, or they just sent you that update in February that you quoted? And did you provide them with any additional information demonstrating it's a major contribution to patient care, either upon request or proactively? And if there's no update on timing of their decision, what are you able to do in terms of launch preparations without spending too much, given some of your capital constraints? Sure. Thanks, Gary. Thanks for joining. Thanks for the question. Let me take the question in pieces.
spk09: We submitted a number of documents and arguments, even clinical data, to support our major contribution to patient claim throughout the process. We've touched the agency in a number of different ways since we got the original notice. including interacting with the commissioner's office, with the head of CEDAR, with the project team, and even the Office of General Counsel to try to understand, A, what the issue was and what the timing would be. In each case, they've assured us that they're working actively on it but don't have a time frame. You know, this is an important product for this patient population. You can see the data. A good portion of the patient population is still without a product that they think is attractive to them. So we're working hard to get through that. The agency has continued to take the position at this point that there's nothing more that they need from us, but that they have more work to do. We'll continue to interact with them in whatever way we can to try to move this along, but right now it appears that they've got work to do internally, and we'll support it when asked. The last part of your question, I'm sorry, was about launch preparation. Obviously, the biggest part of our spend in a launch is going to be building out the sales force. As you know, we've got a sales force in place for Simpazan. We've always looked at that sales force as the kind of advanced beachhead party for launching LiberVant. We're not going to build up the sales force until we have knowledge of an approval and access to the market. But in terms of positioning KOLs, positioning prescribers, and you recall that there's a very, very high degree of overlap between Simpazan prescribers and potential LiberVant prescribers. helping them understand what that product could be if it's approved and granted access, and having them positioned to be prepared to write as quickly as it's launched are all things we'll continue to do until we can build out the sales force.
spk06: Okay, great. And then just a couple more on epinephrine. So part two of Epifast, how many patients will that include? And which dose or formulation are you evaluating for that? And at this point, what do you expect just will be involved in the pivotal PK study, if you have some visibility on that? And then for Ernie, just how much is left on the ATM that you can tap into? And the $30 million contingent debt, if LibraVan gets market access, any additional restrictions on that or limitations in terms of timing or and could it be possible to push that out again if you don't hear from the FDA? Thank you.
spk09: Let me go backwards, and then I'll leave you with Professor Barber on the epinephrine questions, okay? We certainly think that $30 million will be available to us at whatever time we have a decision for market access for LiberVant, Our debt holders have been incredibly cooperative and collaborative up to this point. We see no reason why they wouldn't continue to be at this point. As you know, we've moved that date back now two or three times already based on FDA actions. There's probably just under $40 million left on the ATM at this point in time, give or take a dollar or two. We have not been in the ATM market very much recently, so that number's been stable since around the end of the year. And I'll let Dan walk you through the epinephrine questions.
spk03: Morning, Gary. So there's 24 subjects in Part 2. And just as a reminder, this is a partial replicate crossover study with 0.3 milligram IM. So in part one, we compared ourselves to the 0.5, which is the higher dose, seldom used version of the IM. And what you'll see in part two is a nice comparison to the product that is used almost exclusively in the marketplace. So we're excited to see that data because that will give us a really good data set on how we compare to what could be our reference listed products as we go into the pivotal study. In terms of the formulation that we put in, I wouldn't focus so much on the different iterations that we have done in the first in human and in part one. I think the way we would have you think about it and frame it is we have a formulation we're really excited about. We think the formulation has really good potential to be the commercial formulation and the results we saw in Part 1 lead us to believe that we'll get the right comparison to the .3 IM out of Part 2. So what you'll see us do is obviously complete Part 2. We'll go right into Part 3, and before the end of the second quarter, we'll have our entire epifast study results available, and that'll be a spot where we can really show you where we are as a program pivotal study. So if we continue to get the results that we expect, yes, the formulation in part two would be the one we see in the pivotal study. But obviously, clinical development, product development is a process, and we'll see how the results unfold as the year goes on.
spk06: Okay, that's helpful. Thanks, guys.
spk01: Our next question comes from Jason Butler with J&P Securities. Your line is open.
spk05: Hi, thanks for taking the questions. Had a couple on epinephrine. Can you maybe expand a little bit more on the data that you'll get from Part 2 and Part 3 and what actually it will inform in terms of the pivotal trial design, both in terms of statistical assumptions, but also how those data will inform the final commercial product profile? And then secondly, can you talk about manufacturing capabilities for AQST 109? What else needs to be done to fully integrate the product to be ready in your commercial manufacturing facility and produce those commercial batches? Thanks.
spk03: Sure. So, and Jason, keep me honest. I want to make sure I get all of the parts of your questions. So, in part two, we will get – a nice crossover look versus the 0.3 IM intramuscular injection, right? So we'll have a really good look at a variety of measures, not just median Tmax, Cmax, AUC, but all of the elements that we know are important to the agency for this particular drug, which would include the partial AUCs, you know, 10 minutes, 20 minutes, time to 100 picograms There's also a variety of well-known pharmacodynamic measures, changes in systolic blood pressure, heart rate. All of those measures will have a nice amount of data out of Part 2. The other thing we're doing in Part 2 is the IM is a replicate design. You asked what are we doing to inform the pivotal study. We'll be able to use the replicate portion of part two to really define patient size or subject size, excuse me, that we will need in the pivotal study. And you can see from those who've come before us that given the variability of epinephrine, especially as we've seen in the injection form, those PK studies can be larger than usual, right? I think in the case of OVQ with their it was over 80 subjects. So we would expect part two to help inform us on that. Part three is more about showing the agency how our product will perform, we'll call it under conditions of use. So if someone has a peanut butter and jelly sandwich and then takes our film, if someone has a cold liquid and then takes our film, that's some of the data that we'll get out of part three And that will allow us, when we go to the FDA, to show a robust package and get them comfortable with our program. I think the last part of your question was on manufacturing capabilities. The tech transfer and scale-up process is already underway, and we continue to plan on being through that process before we get too far into the fall. So one of the things you'll look for in that is when we're able to say we've made our registration batches and put product on stability, because that will be a key moment or milestone in that process. Jason, did I answer all of your questions? Yes, that's great.
spk05: Thanks, Dan. Really appreciate it.
spk01: Our next question comes from Thomas Flatton with Lake Street Capital. Your line is open.
spk02: Good morning, guys. Without wishing to antagonize the agency, are there any other remedies available to you? Are there citizen's petition-like activities that patient groups could undertake? Anything like that that could up the pressure on the agency?
spk09: You started out by saying not wanting to antagonize the agency and then picked probably one of the things that would be the most antagonistic to use as an example of We're trying the best we can, Thomas, to interact with them. We've had a good relationship with them through the years, right? We've built it on a principle of being collaborative, being open with them, dealing with problems head on, not trying to kind of opaquely get around things. We have a good relationship with this division. We'd like to keep it that way, but at the same time, we do believe they have an obligation, and we do believe it's inappropriate to miss commitment dates and then have an unlimited and undefined period of time with which to do the work that they're charged with. As I said earlier, we have interacted with the Commissioner's Office, we have interacted with the commissioner's ombudsperson. We have interacted with the head of CEDAR and with the project team. We'll continue to do that. We'll try to find ways to do it in a non-antagonistic way. But we deserve an answer, and we want to drive to one. So, yeah, we may get more aggressive as time goes on. But we're going to try to do it in as constructive a way as we possibly can. I just walked the tightrope there. I hope you appreciate that. But we're certainly not going to come out guns blazing while we're trying to work with them to get to the right outcome.
spk02: Got it. And then one for Ernie. You mentioned in your prepared comments the opportunity for future royalty monetization deals. Is that something you would consider if LiberBank continues to be delayed, or is that part of the plan regardless of what happens with LiberBank?
spk08: I think in my comments, Thomas, I mentioned a variety of products that we have that are commercialized and producing royalties. I think we could be opportunistic to monetize any or all of those royalties, and LiberBank certainly, if approved, could. could fall into that basket.
spk02: Got it. Appreciate it, guys. Thank you.
spk01: Our next question comes from Ram Savarahu with HC Wainwright. Your line is open.
spk07: Thanks very much for taking my questions. Firstly, I just wanted to get a quick clarification on some of the language in the press release that pertains to the timing with which you expect commercialization of liver event to occur. assuming approval. Can you just clarify how quickly you expect the product would be available once you were to receive an approval, if that occurs?
spk09: Sure. As we've said before, Ram, we certainly believe that the strategy that we employed of launching Simpazan first into the very prescriber community that will be interested in LibriVant is going to help us commercialize LibriVant when it is approved. Our intent would be as quickly as we can get product into distribution, as quickly as we can get into prescriber offices and get LibriVant onto their prescription pad for some of their patients. That's as quickly as we'll launch LiberVant with the existing sales force. In parallel, the minute we know we're going to be granted market access in the United States, we'll begin building out the sales team. We'll wind up with 60-plus prescriber-focused facing people out in the field trying to drive that business. But we won't build out the sales force until we have clear visibility into that market access. But the existing sales force is trained, they're prepared, and as soon as we have product to distribute in the FOA distribution centers is as fast as LiberVant will start to be written and filled.
spk07: Can you also comment on your 2022 guidance and plans What specifically is in there relating to LiberVent, if anything, at this juncture?
spk08: I think we were pretty clear in the prepared remarks that we have not included any revenue in the guidance for LiberVent, and we wouldn't until the product is approved by the U.S. FDA for market access and it is launched. So there is zero revenue in there this year in the guidance.
spk07: Okay. And then, um, with respect to additional, uh, non us business development activities, uh, you know, we saw recently the extra van China licensing deal. Can you comment on whether we should expect any other potential transactions in that vein? And if so, uh, which elements of your portfolio are most likely to be the subject of, of such transactions? You know, if to whatever extent you're able to comment on that at this point, Also, in future, if you have a portfolio of those non-U.S. kind of regional deals that may ultimately wind up generating revenue, can you comment on strategically how you're thinking about potentially monetizing those most effectively, and if you might seek to do things that are similar to what you did with the Kinmobi royalty stream going forward? Obviously, those are hypotheticals, but just wanted to get your take on that at this time.
spk09: No, that's a great question. Thanks, Ram. Look, our core business continues to do a pretty good job of creating cash and opportunities for us. We've announced a number of deals over the last few years, and we'll continue to search for those. Our strategy currently is we'll focus on marketing in the United States, and we'll license outside the United States for the core proprietary products like Simpazan and LiberBand and others. Our strategy is to extract whatever value we can out of the assets we have in our portfolio, whether they're already approved in the United States or not. And You know, Exervant is a good example. We've got three different deals relating to that. Zooplans is another good example. We announced a deal last year, and Hypera just got an approval in Brazil. So we'll continue to look at those opportunities. Obviously, Libervant, once it's clarified here in the United States, is potential for deals outside the United States. We'll continue to look for ways to extract value out of our assets as we always have, and I think we've done, frankly, a very good job of that. Royalty streams are a great optionality to have, right? We always will evaluate whether or not they're more valuable as cash flow periodically to us as the royalty payments are made or whether they represent an opportunity to be monetized much as we did with Kinmobi in one transaction that provides a slug of cash and some potential upside over time. We wanted to be clear to people who look at our cash balance and our spend and do simple math and talk about Cash Horizon that there are other opportunities for cash on our balance sheet. Actually, they may not even be cash on our balance sheet in the case of the $30 million available under the debt facility. That there are sources of capital, and these royalties represent that, that we have available to us as we go forward. As each of the products that are generating royalties mature and age in their respective markets, we'll continue to monitor what the royalty monetization market is willing to pay for them and make a choice about whether or not they're more valuable as cash flow or they're more valuable as a transaction. But they represent assets to us in either case.
spk01: Thank you. If there are no further questions, I'd like to turn the call back over to Keith Kendall for any closing remarks.
spk09: Great, thank you, Operator. Thank you, everyone, for joining us this morning. We appreciate it, as always. We appreciate your questions and the chance to address them with you. We've got a lot of exciting things in front of us. Obviously, trying to resolve the FDA's decision around liver vans is job number one, and job number 1A, obviously, is taking action. epinephrine and AQST-109 through the rest of the epifast study, getting back to a discussion with the agency and moving toward our pivotal trials at the end of the year if all works as planned and hoped. We look forward to keeping you updated on all of those and I know we'll be talking to you in another 60 days or so at the end of our first quarter so we look forward to that as well and again thank you for joining us and We'll talk to you all soon.
spk01: This concludes the program. You may now disconnect. Everyone, have a great day.
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