Aquestive Therapeutics - Earnings Call - Q4 2021

Transcript

Speaker 0

Good morning and welcome to the Aquestive Therapeutics Fourth Quarter and Full Year twenty twenty one Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As there a question a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson of Westlake Investor Relations.

You may begin.

Speaker 1

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 and A session. 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 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 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 our annual report on Form 10 k filed with the Securities Exchange Commission on 03/08/2022 and in our quarterly reports on Form 10 Q and current reports on Form eight k filed with the SEC. 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 development, regulatory approval, and commercialization of its products, and other matters related to operations.

The impact of the ongoing COVID nineteen 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 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 statement after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law.

With that, I will now turn the line over to Keith.

Speaker 2

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 2021 and through early March. As always, Ernie and I will be joined by additional members of the Aquestive leadership team during the Q and A session afterward. We remain as a company keenly focused on the two most important value drivers for Aquestive, Libervant and AQST one zero nine. 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 one zero nine and the commencement of part two of that study. In late February, we received clearance from the FDA for The US IND for AQST one zero nine. 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 12/20/2021, we received notification from the FDA that it would not be ready to act by the PDUFA date of December 23 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 paid 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 a question. At this time, we cannot provide a specific update regarding timelines or an anticipated action date, close quotes. The company continues to believe that Libervant 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 Libervant represents a clinically superior product to the previous rectal and nasal products based on Libervant providing a major contribution to patient care as outlined in the agency's guidelines.

Libervant, 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 twelve 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 PharmFilm technology provides a preferred oral product that will be a meaningful improvement in treatment options available

Speaker 3

for these patients.

Speaker 2

Aquestive 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, AQST one zero nine. Aquestive is advancing the clinical development of AQST one zero nine, the first and only orally delivered epinephrine product candidate to demonstrate results comparable to auto injectors such as EpiPen and Aviq that are the current standard of care for the emergency treatment of severe allergic reactions. As we had committed on our last call, we announced in late February that the FDA has provided clearance for Aquestive'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 twenty three or early twenty four. As a reminder, the agency previously confirmed the five zero five b two regulatory approval path as appropriate for AQST one zero nine. Additionally, we announced in late February positive top line results from part one of our epiFAST study evaluating AQST one hundred nine. 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 t max of thirteen and a half 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 one hundred and nine represents a meaningful improvement in this group of patients and caregivers lives. We're looking forward to the continued development of AQST one hundred nine. And as we've indicated previously, we expect to move forward with the manufacturer registration batches and to commence pivotal trials in The US under the IND before the 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. SYMPAZAN 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 signed a new licensing agreement with a China based pharmaceutical company, Heisko, for the development, manufacture, and commercialization of Exservan in China.

The deal contributes $7,000,000 of upfront cash, manufacturing revenue with Aquestive as the sole supplier to HiSCO, and double digit royalties once the product is launched in China. In conclusion, as we progress through the 2022, we're focused on advancing our proprietary products. We remain in close contact with the FDA regarding the application for Libervant. The FDA is continuing to evaluate the impact of orphan drug exclusivity on our NDA. We believe that Libervant 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 US market access. AQST has advanced into part two of the epifast study after we reported positive results from part one last month. Concurrently, FDA has 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.

Speaker 4

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 twenty twenty one results in the Q and A. Complementing our business focus on the priorities of Libervant and AQST-one hundred nine 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 $30,000,000 available within our existing debt facility from December 2021 until June 2022 if we choose to fully fund the launch of Libervant 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 twenty twenty one, we recognized a onetime noncash loss and extinguishment of debt of $13,800,000 for fees and expenses related to the fourth supplemental indenture that was executed on 10/07/2021. This agreement with our lenders amended the principal amortization schedule to free up over $10,000,000 of capital between the execution date and year end 2022 for a $2,700,000 fee payable in four quarterly installments beginning 05/15/2022. 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 a $0.36 loss per share for the full year based on the weighted average number of shares outstanding for the three and twelve months ended 12/31/2021. Also, the full year effect of the accounting for the Kenobi royalty monetization transaction was $12,400,000 in interest expense related to the sale of future revenue resulting in an EPS impact of 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, SYMPAZAN generated sequential quarterly revenue growth for the twelfth straight quarter. Our trends in wholesaler shipments of SYMPAZAN to retail pharmacies and growth in new and repeat prescribers represent a very solid 77% increase when you compare the fourth quarter twenty twenty one 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 12/31/2021, cash and cash equivalents were $28,000,000.

During the fourth quarter twenty twenty one, we received $5,200,000 in net proceeds from our at the market or ATM facility. For the year ended 12/31/2021, we received $29,800,000 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 that meet expected cash requirements for the next twelve months. While

Speaker 3

we

Speaker 4

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 US market access by the FDA, to be funded by the additional $30,000,000 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 Aztaris, which was launched in 2021 by Corium under license from ChemPharm, Suboxone in markets outside of The US with Indivior, Exservan in The US with Mitsubishi Tanabe, in The EU with Zambon, and has recently announced in China with Hysco, as well as the launch of ondansetron by Hypira 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 Kymobi royalties.

As outlined in the press release issued last night after market close, we issued our full year twenty twenty two financial guidance. SYMPAZAN 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 in R and D is projected to accelerate as we continue development of AQST-one hundred nine 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 $42,000,000 to $47,000,000 non GAAP adjusted gross margin of approximately 70% to 75% and non GAAP adjusted EBITDA loss of approximately $51,000,000 to $58,000,000 It is worth reiterating that this 2022 financial guidance does not include any revenues from Libervant 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 SYMPAZAN and significant additional focused R and D investments related to the advancement of AQST-one hundred nine. 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.

Speaker 0

Our first question comes from Gary Nachman with BMO Capital Markets. Your line is open.

Speaker 5

Hi, good morning guys. Regarding FDA's communication on Libervant, 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?

Speaker 3

Sure. Thanks, Gary. Thanks for joining. Thanks for the question. Let me take the question in pieces.

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 timeframe. 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. So 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 SYMPAZAN. 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 SYMPAZAN 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 that sales force.

Speaker 5

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? 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 30,000,000 contingent debt, if Libervant gets market access, any, you know, additional restrictions on that or limitations in terms of timing? And could it be possible to push that out again if you don't hear from the FDA? Thank you.

Speaker 3

Let me go backwards, and then I'll leave you with Professor Barber on the epinephrine questions, okay? We certainly think that the $30,000,000 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 $40,000,000 left on the ATM at this point in time, give or take $1 or 2 We have not been in the ATM market very much recently. So that number has been stable since around the end of the year. And I'll let Dan walk you through the epinephrine questions.

Speaker 6

Morning, Gary. So there's 24 subjects in Part two. And just as a reminder, this is a partial replicate crossover study with the 0.3 So in Part one we compared ourselves to the zero point five, which is the higher dose seldom used version of the I'm 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 product as we go into this 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

Speaker 1

have you think about it and

Speaker 6

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. It's the right size for patient use. It has the right components. And the results we saw in part one lead us to believe that we'll get the right comparison to the point three I'm out of part two.

So what you'll see us do is obviously complete part two. We'll go right into Part three. 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. Out of that, we'll go meet with the FDA, as we've talked about before.

And after that meeting with the FDA we would start our 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.

Speaker 5

Okay, that's helpful. Thanks guys.

Speaker 0

Our next question comes from Jason Butler with JMP Securities. Your line is open.

Speaker 5

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 two and Part three 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 just talk about manufacturing capabilities for AQST-one 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. Sure.

Speaker 6

So, Jason, keep me honest. I want 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 I'm 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, ten minutes, twenty minutes, time to one hundred picograms per milliliter, it seems to be a spot that the agency is interested in. And 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 two. The other thing we're doing in Part two is the I'm is a replicate design. So 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.

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. I think in the case of OPQ with their pivotal study, 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, 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. That process is 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?

Speaker 5

Yep, that's great. Thanks, Dan. Really appreciate it.

Speaker 0

Our next question comes from Thomas Flaten with Lake Street Capital. Your line is open.

Speaker 7

Good morning, guys. Without wishing to antagonize the agency, are there any other remedies available to you? Are there citizens petition like activities that patient groups could undertake? Anything like that that could up the pressure on the agency?

Speaker 3

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. 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 nonantagonistic way. But we deserve an answer and we want to drive to one. So yes, 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 a 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.

Speaker 1

Got it.

Speaker 7

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 Libervant continues to be delayed? Or is that part of the plan regardless of what happens with Libervant?

Speaker 4

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 Libervant, certainly if approved, could fall into that basket.

Speaker 1

Got it. Appreciate it guys. Thank you.

Speaker 0

Our next question comes from Ram Selvaraju with H. C. Wainwright. Your line is open.

Speaker 8

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 Libervant 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?

Speaker 3

Sure. As we've said before, Ram, we certainly believe that the strategy that we employed of launching SYMPAZAN first into the very prescriber community that will be interested in Libervant is going to help us commercialize Libervant when it is approved. We our intent would be as quickly as we can get product into distribution, as quickly as we can get into prescriber offices and get Libervant 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 forward distribution centers, it's as fast as Libervant will start to be written and filled.

Speaker 8

Can you also comment on your 2022 guidance and what specifically is in there relating to Libervant, if anything, at this juncture?

Speaker 4

I think we were pretty clear in the prepared remarks that we have not included any revenue in the guidance for Libervant. And we wouldn't until the product is approved by the US FDA for market access and it is launched. So there's zero revenue in there this year in the guidance.

Speaker 8

Okay. And then with respect to additional non U. S. Business development activities, we saw recently the Exservan China licensing deal. Can you comment on whether we should expect any other potential transactions in that vein?

And if so, 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 US 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, are hypotheticals, but just wanted to get your take on that at this time.

Speaker 3

No, that's a great question. Thanks, Ram. Look, we are 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 SYMPAZAN and Libervant 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. Exservan is a good example. We've got three different deals relating to that. Zooplens is another good example. We announced a deal last year and Hypira 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 $30,000,000 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 those 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.

Speaker 0

There are no further questions. I'd to turn the call back over to Keith Kendall for any closing remarks.

Speaker 3

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 Libervant is job number one. And job number 1A obviously is taking epinephrine and AQST-one hundred and nine 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 sixty 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.

Speaker 0

This concludes the program. You may now disconnect. Everyone, have a great