Good morning and welcome to the Aquestive Therapeutics Fourth Quarter and Full Year 2021 Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions] As a reminder, this call will be recorded. I would now like to introduce your host for today’s conference call, Bennett Watson of Westwicke Investor Relations.

You may begin..

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 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 the 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 and 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 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-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 Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday.

The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events or otherwise, except as required under applicable law. With that, I will now turn the line over to Keith..

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 Aquestive leadership team during the Q&A session afterward. We remain as a company keenly focused on the two most important value drivers for Aquestive, Libervant and AQST-109. 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 1 of the EPIPHAST crossover study for AQST-109 and the commencement of Part 2 of that study. In late February, we received clearance from the FDA for the U.S. 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 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 PADE audit. Since that notice in December, we have 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 again, “we are continuing to consider the information and arguments submitted by and on behalf of Aquestive.

At this time, we cannot provide a specific update regarding timelines or an anticipated action date.” 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 have made a compelling case that Libervant represents a clinically superior product to their 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 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 PharmFilm technology provides a preferred oral product that will be a meaningful improvement in treatment options available for these patients. 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-109.

Aquestive is advancing the clinical development of AQST-109, the first and only orally delivered epinephrine product candidate to demonstrate results comparable to auto-injectors such as EpiPen and Auvi-Q 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 ‘23 or early ‘24.

As a reminder, the agency previously confirmed the 505(b)(2) regulatory approval path as appropriate for AQST-109. Additionally, we announced in late February positive top line results from Part 1 of our EPIPHAST study, evaluating AQST-109.

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 13.5 minutes. We are obviously pleased with these results and have already begun Part 2 of the study and expect to report top line data before the end of the second quarter.

We are excited that we have again shown pharmacokinetic results that demonstrate delivery of epinephrine with the absorption and conversion speed necessary for our rescue product at this time.

With the 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 are looking forward to the continued development of AQST-109 and as we have indicated previously, we expect to move forward with the manufacture of registration batches and to commence pivotal trials in the U.S. under the IND 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. 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 have signed a new licensing agreement with a China-based pharmaceutical company, Haisco, for the development, manufacture and commercialization of EXSERVAN in China.

The deal contributes $7 million of upfront cash, manufacturing revenue with Aquestive as the sole supplier to Haisco and double-digit royalties once the product is launched in China. In conclusion, as we progress through the first quarter of 2022, we are 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 are prepared to launch immediately if granted U.S. market access. AQST has advanced into Part 2 of the EPIPHAST study after we reported positive results from Part 1 last month. Concurrently, the FDA has provided clearance for the IND and we are 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..

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 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&D investments related to the advancement of AQST-109.

At the same time, we will continue to prudently manage our cost 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..

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

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 is 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. 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 have assured us that they are working actively on it, but don’t have a time frame. 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 is nothing more that they need from us, but that they have more work to do. So we will continue to interact with them in whatever way we can to try to move this along. But right now it appears that they have got work to do internally and we will support it when asked.

The last part of your question, I’m sorry, was about launch preparation. Obviously, where the biggest part of our spend in the 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 beach head 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 is 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 will continue to do until we can build out the sales force..

Okay, great.

And then just a couple more on epinephrine, so Part 2 of EPIPHAST, 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 Libervant gets market access, any 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..

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 2 or 3x already based on FDA actions. Its probably just under $40 million less 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..

Good morning, Gary. So there is 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 1, we compared ourselves to the 0.5 milligram, which is the higher dose seldom-used version of the IM.

And what you’ll see in Part 2 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 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 1. 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.

It’s the right size for patient use. It has the right components and the results we saw in Part 1 lead us to believe that we will get the right comparison to the 0.3 milligram IM out of Part 2. So what you’ll see us do is obviously complete Part 2. We will go right into Part 3.

And before the end of the second quarter, we will have our entire EPIPHAST study results available, and that will be a spot where we can really show you where we are as a program. Out of that, we will 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 2 would be the one we see in the pivotal studies, but obviously, clinical development, product development is a process, and we will see how the results unfold as the year goes on..

Okay. That’s helpful. Thanks, guys..

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

Hi, thanks for taking the questions. I 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 that data will inform the final commercial product profile? And then secondly, can you just 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..

Sure. So – and Jason, to be honest, I want to make sure I get all of the parts of your question. So, in part two, we will get a nice crossover look versus the 0.3 milligram IM intramuscular injection, right.

So, we will 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, 10 minutes, 20 minutes time to 100 picograms per milliliter. It seems to be a spot that the agency is interested in.

And there is 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 are doing in part two is the IM is a replicate design. So, you asked how are we – what are we doing to inform the pivotal study.

We will 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 come before us that given the variability of epinephrine, especially as we have seen in the injection form, those PK studies can be larger than usual, right.

I think in the case of Auvi-Q with their pivotal study 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 products will perform, call it under conditions of use.

So, if someone has a peanut butter jelly sandwich and then takes our film, if someone has a cold liquid and that takes our films, that’s some of the data that we will 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 will look for in that is when we are able to say we have 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. Thanks, Dan. Really appreciate it..

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

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?.

You started out by saying not wanting to antagonize the agency and then take probably one of the things that would be the most antagonistic to use as an example. We are trying the best we can, Thomas, to interact with them. We have had a good relationship with them through the years, right.

We have built it on – we have 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 would 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 are charged with. As I said earlier, we have interacted with the commissioner’s office. We have interacted with the commissioners on person.

We have interacted with the Head of Cedar, and with the project team. We will continue to do that. We will 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 yes, we may get more aggressive as time goes on, but we are going to try to do it in as constructive a way as we possibly can.

I just walk the tight rope there. I hope you appreciate that. But we are certainly not going to come out guns blazing while we are trying to work with them to get to the right outcome..

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

Yes. 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..

Got it. Appreciate it, guys. Thank you..

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

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?.

Sure. As we have 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 pads for some of their patients. That’s as quickly as we will launch Libervant with the existing sales force.

In parallel, the minute we know we are going to be granted market access in the United States, we will begin building out the sales team. We will 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 are prepared. And as soon as we have product to distribute in the forward distribution centers is as fast as Libervant will start to be written and filled..

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

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 U.S. FDA for market access and it is launched. So, there is zero revenue in there this year in the guidance..

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 such transactions, if to whatever extent you are 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 are thinking about potentially monetizing those most effectively? And if you might seek to do things that are similar to what you did with the KYNMOBI royalty stream going forward.

Obviously, those are hypotheticals, but just wanted to get your take on that at this time..

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 have announced a number of deals over the last few years and we will continue to search for those.

Our strategy currently is we will focus on marketing in the United States, and we will 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 are already approved in the United States or not.

And EXSERVAN is a good example. We have got three different deals relating to that. Zuplenz is another good example. We announced the deal last year and Hypera just got an approval in Brazil. So, we will continue to look at those opportunities.

Obviously, Libervant, once it’s clarified here in the United States, is a potential for deals outside the United States. We will continue to look for ways to extract value out of our assets as we always have. And I think we have done, frankly, a very good job of that. Loyalty streams are a great optionality to have, right.

We always will evaluate whether or not they are more valuable as cash flow periodically to us as the royalty payments are made or whether they represent an opportunity to be monetized as much as we did with KYNMOBI in one transaction that provides slugging 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 there 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 those products that are generating royalties, mature in age in their respective markets, we will continue to monitor what the royalty monetization market is willing to pay for them and make a choice about whether or not they are more valuable as cash flow or they are more valuable as a transaction, but they represent assets to us in either case..

Thank you..

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

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 have 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 #1A, obviously is taking epinephrine and AQST-109 through the rest of the EPIPHAST study, getting back to a discussion with the agency and moving towards 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 will 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 will talk to you all soon..

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