Aquestive Therapeutics - Earnings Call - Q1 2021

Transcript

Speaker 0

Good morning, and welcome to Aquestive Therapeutics First Quarter 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 As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Ms. Stephanie Carrington of Westwicke Investor Relations.

Please begin.

Speaker 1

Thank you, operator. Good morning, and welcome to today's call. On today's call, I am joined by Keith Kendall, President and Chief Executive Officer and Ernie Toth, Interim Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the 2021, followed by a Q and A session. In total, we expect today's call to last approximately sixty minutes. 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 Aquesta's website within the Investors section shortly following the conclusion of this call. To remind you, the Aquesta team will be discussing some non GAAP financial measures this morning as part of its review of first quarter twenty twenty one 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 Aquesta'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 are described in the Risk Factors section included in the company's annual report on Form 10 ks filed with the SEC on 03/10/2021.

As with any pharmaceutical company, the product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval and commercialization of its products and other matters related to operations. 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 of 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 these cautionary statements 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 result of new information, future events or otherwise, except as required under applicable law. With that, I'll now turn the line over to Keith.

Speaker 2

Thank you, Stephanie, 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 April. As always, Ernie and I will be joined by additional members of the Aquestive leadership team during the Q and A session afterward. Through this period, we were able to execute on our key priorities and delivered a number of key milestones that we'll talk about this morning. First and foremost, we continue to focus on building our CNS franchise.

Our team is focused on preparing the resubmission of our new drug application for Libervant. After receiving guidance from the FDA on its expectations for information and supporting analysis relating to the pharmacokinetic modeling and simulations included in our prior submissions to the agency in December 2020, we're completing the necessary analysis of the existing clinical data in response to the FDA's feedback. We're developing Libervant as an alternative to more invasive, inconvenient and difficult to administer device driven products, including a rectal gel for patients with refractory epilepsy. As a result of these issues, a large portion of the patient population does not receive adequate treatment or forgoes treatment altogether. We continue to believe that Libervant if approved by the FDA for U.

S. Market access will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non invasive and innovative treatment form. As we previously communicated, we resubmitted to the FDA a revised weight based dosing regimen along with modeling and simulations data in December 2020 to address issues raised by the agency in the CRL we received in September 2020. The FDA confirmed that the issues identified in the CRL may be addressed by utilizing modeling and simulations based upon the information provided in our FDA meeting package submitted in October. In response to our December submission, the FDA provided written feedback in February that clarified the agency's expectations relating to the information to be presented in the population PK model and the safety data that should be included in the NDA resubmission.

Based on the FDA's feedback, we continue to believe that no further clinical studies will be necessary for the resubmission of the NDA for Libervant. We are on track to complete these analyses and resubmit the NDA as committed by the end of the 2021. Once resubmitted, we anticipate a six month review process. We continue to expect the PDUFA action date in 2021. There have been no indications to date from the FDA relating to approval for market access, however, and we do not expect to receive any FDA guidance regarding market access prior to the PDUFA action date.

Regarding FDA approval of U. S. Market access, we believe that we have provided a strong set of facts supporting a decision by the FDA of clinical superiority to prior approved drugs for this indication based upon a finding that Libervant represents a major contribution to patient care. Once we've resubmitted the NDA for Libervant, we will reengage with the FDA and update our prior communications to demonstrate our position that Libervant as an orally delivered product meets one or more of the following criteria to be considered a major contribution to patient care: convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration and longer periods between doses. Subject to FDA approval, we're committed to launching Libervant as soon as possible after that approval.

Our next key priority is our epinephrine program. At our R and D event in March, our team and two nationally recognized KOLs provided an overview of anaphylaxis, discussed the hurdles that accompany the needle based delivery standards of of care and outline the significant market opportunity that exists for a highly differentiated formulation utilizing our PharmFilm sublingual formulation. Our R and D team provided an extensive review of our two epinephrine project candidates, clinical results and development strategy for the program. As you may recall, our first generation candidate AQST-one hundred eight was granted Fast Track designation last year and was approved to use the five zero five(two) regulatory pathway by the FDA, potentially making the clinical development trajectory faster and cheaper. Moreover, the FDA acknowledged that our sublingual film formulation of epinephrine satisfies an unmet need in the patient population relating to those patients resistant to taking intramuscular or subcutaneous injections.

As such, our candidates have the potential to be the first orally administered epinephrine based rescue medications for this patient We anticipate that any product candidate that we bring forward for this indication would be eligible for Fast Track designation. At the March R and D event, our team reviewed the clinical data from the two completed Phase one PK studies for AQUESTIV-one hundred eight composed of the prodrug dipivephrine. The data from the two Phase I PK studies demonstrate that AQUESTIV-one hundred eight can consistently deliver epinephrine sublingually and all subjects had measurable plasma concentrations of epinephrine. The top line data for AQUESTIV-one hundred eight provides further evidence that we have developed a unique technological solution that can deliver epinephrine sublingually. We have filed multiple patent applications to protect these findings and we're excited by the possibilities this new platform presents to Aquestive.

The first in human PK study for our second generation candidate AQST-one hundred nine commenced just a few weeks ago after the trial dossier received clearance from Health Canada. We are on track to complete Part one of this study in the 2021 and anticipate scheduling a meeting with the FDA shortly thereafter to discuss a path forward to the regulatory approval for AQST-one hundred eight and AQST-one hundred nine. Finally, our first proprietary commercial product SYMPAZAN continues to meet key performance metrics. Throughout the 2021 SYMPAZAN continued to perform and grow despite COVID-nineteen related restrictions on face to face interactions with healthcare providers. It is worth noting that while total prescriptions nationally were down 8% in the first quarter of this year, SYMPAZAN script shipped to pharmacies grew nearly 13% quarter over quarter and 40% year over year.

Our continued growth in prescriptions and net revenue demonstrates our ongoing ability to continue to connect with the prescribers even virtually and grow this product. SYMPAZAN saw continued growth in the prescriber base with over 30% penetration into the company's focused group of prescribers with approximately 80% of those prescribers writing multiple scripts. We believe our position with prescribers in the epilepsy field and payers continues to pave the way for successful launch of Libervant, if approved, given their familiarity with our PharmFilm technology and the major contribution to patient care that our products provide to epilepsy patients. In conclusion, as we progress through the spring, we're focused on advancing our proprietary products. Our team is continuing to perform the additional analyses outlined by the FDA and actively drafting our NDA resubmission for Libervant.

We expect to resubmit at the end of the 2021 and subject to FDA approval for U. S. Market access, we are committed to launch Libervant as soon as possible after approval. We commenced the first in human Phase I PK study for AQUESTIV-one hundred nine in April 2021. This prodrug candidate has demonstrated very compelling data for rapidly converting into systemic epinephrine in animal models.

We look forward to completing the Part one of this study later in the year. Thereafter, we're planning for an FDA meeting in the 2021 to discuss a path forward for AQST-one hundred eight and AQST-one hundred nine. And as demonstrated by our first quarter figures, we continue to efficiently grow SYMPAZAN shipments and revenue as well as expanding strategic relationships across the epilepsy market in preparation of a potential Libervant launch. We look forward to continuing to update all of you as we advance these initiatives throughout 2021. With that, I'd like to turn the floor over to Ernie, who'll provide specifics around financial performance and outlook.

Ernie?

Speaker 3

Thank you, Keith, and good morning, everyone. By now, you will have seen our financial results in our 10 Q and earnings release that were filed last evening. As we typically do, we will address most of the discussion related to the first quarter twenty twenty one results in the Q and A. We have reconfirmed our full year 2021 financial guidance as previously indicated in our fourth quarter release issued during the March 2021. Overarching our 2021 strategy are some key principles that Keith outlined in his remarks, including: we are focused in 2021 on our two most important value drivers: Libervant's resubmission, approval and launch and the continued development of our epinephrine program.

While we are targeting a late twenty twenty one PDUFA date, we have included zero revenue from Libervant in our full year 2021 guidance until we are certain of approval and launch timing. Our epinephrine program is advancing with our second prodrug AQST-one hundred nine currently in a Phase I PK trial. And while we do not specifically guide on SYMPAZAN revenue, as Keith mentioned previously, our trends on wholesaler shipments to retail pharmacies and growth in new and repeat prescribers are very solid quarter over quarter, and we anticipate continued growth into 2021. And while Suboxone is a legacy product for us, it remains a significant part of our near term revenue outlook. Our total revenues were $11,100,000 in the 2021 compared to $8,800,000 in the 2020.

This year over year increase reflects higher license and royalty revenue and growth in SYMPAZAN revenue. We saw net revenue growth in the 2021 compared to the prior year period, up 56% for SYMPAZAN, the first of our proprietary products to be launched. Our net loss for the 2021 was $14,700,000 or $0.41 loss per share. The net loss for the first quarter twenty twenty was $16,500,000 or $0.49 loss per share. The year over year change in net loss was driven by higher revenue and reductions in cost and expenses, partly offset by increased interest expense related to the sale of future revenue.

This interest expense is due to the accounting associated with the Kynovi monetization on 11/03/2020, and does not represent a cash output or monetary obligation at any time during the life of the transaction. Adjusted EBITDA loss was $6,300,000 in first quarter twenty twenty one compared to $11,200,000 in the 2020. The year over year change in adjusted EBITDA loss was driven by higher revenue and reductions in costs and expenses. As of 03/31/2021, cash and cash equivalents were $27,500,000 During the first quarter twenty twenty one, we accessed capital under our at the market or ATM facility, resulting in net proceeds of $9,900,000 The ATM facility, as amended, has approximately $57,100,000 available at 03/31/2021. As outlined in the press release issued last night after market close, we are reaffirming our full year 2021 financial guidance that we previously provided during the March when we reported our year end results.

For the full year 2021, we expect total revenues of approximately $38,000,000 to $42,000,000 non GAAP adjusted gross margins of approximately 70% to 75% on total revenues and non GAAP adjusted EBITDA loss of approximately $42,000,000 to $45,000,000 With that, I will now turn the line back to the operator to open the line for questions.

Speaker 1

Thank you.

Speaker 0

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

Speaker 4

Hi, this is Evan Kwah filling in for Gary Nachman. Thanks for the update and thanks for taking my question.

Speaker 2

Hi, Evan. So

Speaker 4

I have a few questions. So first, for the additional work that you're doing for Libervant, both for the PK and safety, Could that potentially be helpful to showing a meaningful improvement to patient care and getting the orphan drug designation? And secondly, how soon can you reengage with the FDA on Libervant after you resubmit at the end of the second quarter? Is that immediate or would it take a while and closer to the PDUFA date?

Speaker 2

Sure. Dan, do you want

Speaker 3

to take that?

Speaker 5

Sure. Good morning. So in terms of the safety and PK work that's going into the refiling, the way I would think about the refiling or the resubmission in terms of the benefits of our product is the totality of the package that is really what drives value. So the safety piece that we're updating, which is a very simple piece, of course, is part of our story. And the PK modeling, which relates to the dosing regimen we're creating also is a component of the value that we will drive.

So there's absolutely additional value in the work that we're doing that will go into resubmission that will tie to our market access. In terms of reengaging with the FDA, we will reengage immediately upon resubmission. In fact, I argue we've been in contact with the FDA. We received their feedback back in February. We have engaged back and forth with them from February to now.

And after we've commissioned that, we'll continue.

Speaker 4

Great. And one more follow-up. Would you be able to remind us how you view the size of the market opportunity for Libervant as well as your thoughts on the product for Nurelsus, South Dakota and how you are differentiated?

Speaker 2

Evan, there was some noise in the background that we were not sure where it's coming from. Could you just repeat that question, please?

Speaker 4

Yes. So would you be able to remind us on how you view the size of the market opportunity for Libervant and as well as your thoughts on the competing product New Relis' Valtoco and how you're differentiated? Thanks. Sure.

Speaker 2

Ken, you to take that?

Speaker 6

Yes, sure, Keith. Thanks. Yes, the market opportunity is pretty substantial. If you look at the overall epilepsy market of about three point two million patients, about one point two million of them have some level of refractory disease. And as you talk to physicians, those are the types of patients that they would look to have a rescue strategy in place, which would create an opportunity, quite frankly, for all the rescue medicines.

So it's a pretty substantial market. And if you look at Valtoclo and key points of differentiation, I mean clearly one is a nasal and the other is an orally administered medicine. The key points of differentiation in my mind are the preferred route of administration and then what will likely be our labeled population 12 and older, the need to use two doses of the nasal Valtoco to get an effective level of therapy in those patients will be a pretty significant point of differentiation.

Speaker 2

Thank you.

Speaker 0

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

Speaker 7

Hi, thanks for taking the questions. Had a couple on the epinephrine programs. Can you just remind us for AQST-one 108, how predictive the preclinical data were in translating into the PK profile you saw in the initial human studies? And then following on from that, can you just compare and contrast the profiles you've seen preclinically to date for 01/2009 versus what you saw for 01/2008? Thanks.

Speaker 2

Sure. Jason, I'll let Dan take that question.

Speaker 5

Good morning, Jason, and great question. When you look at the preclinical data for one hundred eight, it was very predictive in our minds of what we saw in the clinic. We saw solid absorption with our Pro drug platform and then we saw a rapid peak of Dipivephrine and conversion into Epinephrine. And as you know, Pro drugs are simply a chemical derivative of the molecule and after absorption, enzymatic cleavage turns the prodrug back into the original molecule. With that predictive model, what we saw was and we talked about this at the R and D Day, the dipiverephrin gave a really interesting and compelling curve, but we think we can do better on the conversion rate.

So with 109 in preclinical models, we have a much faster conversion rate in our second generation prodrug. So preclinically, see rapid absorption, a nice big peak and then you see rapid conversion into epinephrine through the enzymatic cleavage. We're currently in the clinic, as you know, with 109 and we're excited to see the data as we go through that study and we expect that study to read out as Keith mentioned in his remarks earlier in the 2021.

Speaker 6

Great.

Speaker 7

And then just one point from the R and D Day that the docs brought up was what seems to be a pretty meaningful risk of incorrect use or delayed use of injectable epinephrine. Just wondering if you've got any market research to support how important these factors are to both the physician and to patients when thinking about the potential for a different delivery method like an oral epinephrine?

Speaker 5

Sure. Thank you, Jason. Yes, we do have market research that indicates that patients do delay using the current standards of care, because of a variety of issues. And in fact, it's not just our market research, there's a whole wealth or body of research outside of our company that indicates the patients delay using an EpiPen or other injection type epinephrine product for a variety of reasons. And we do believe that our product lowers those barriers and will be a product that over time we can show patients are more willing to take at the onset of any allergic reaction.

So that is absolutely a key differentiator of our sublingual product and we will continue to ensure we understand how to use that differentiation as we go forward.

Speaker 7

Helpful. Thanks for taking the questions.

Speaker 2

Thanks, Jason. Thanks, Jason.

Speaker 0

Thank you. Our next question comes from Dan Busby with RBC. Your line is open.

Speaker 8

Great. Hey, guys. This is Steve on for Dan. Thanks for taking our questions here. I've got two and I'll ask them both upfront.

So the first one is related to despipizan. And I'm kind of curious as we are looking at the current COVID environment and how it's impacting patients to getting in front of doctors and now that our people are getting more vaccinated and restrictions across The U. S. Are starting to line up. How are you thinking about those dynamics and how it's going to impact your business here going forward?

And there's any pent up demand for that you guys are thinking about? And then my second question is related to epinephrine. You guys are in the process of other first in human PK data, which looks like you're going to have some data readout later this year, along with having some conversations with the FDA. I guess I'm trying to get a sense of ultimately what are you looking for to help you make a decision as to which asset you will be more comfortable to pursuing 01/2008 versus 01/2009? Thanks for taking the questions.

Speaker 2

Sure. I'll let Ken Marshall, our Chief Commercial Officer, answer the first part of your question, and then Dan will take the epinephrine

Speaker 6

part of your question, okay? Hi, Steve, this is Ken. If you look back to the start of the pandemic last March, leading into that, about ninety percent of our interactions with healthcare practitioners were live. It went almost immediately to ten percent in that April timeframe. So it a very radical shift.

And now over time as people have figured out how to manage it and set guidelines, you're seeing about a 60 fivethirty five ratio of live to virtual visits and it's ever so slightly trending back up Depending on the week we look at, it can be 70%, 75% live and that's for all healthcare practitioners, physicians and their mid levels. We feel like we're definitely more effective in those types of settings, but we've also learned how to very effectively work in a virtual world with our speaker and peer programs and our interactions with physicians. Speculating, I don't know if it will go back to ninetyten. What we're doing as a company is are encouraging live visits where possible. And following the guidelines of the hospitals and clinics.

If they allow folks in, we go visit them. If they don't, we set up virtual meetings.

Speaker 5

Dan, I'll take the second part of your question. And this is Dan. From a 01/2008 01/2009 perspective, if you look at the data as we laid out for 01/2008, what we were really excited by are a couple of things. One, the rapid peak of dipovephrine, so a Tmax of under twenty minutes for the Pro drug itself. And two, the really interesting PD effect that we saw or pharmacodynamic effect that we saw throughout the data that we collected.

So what we're doing right now with one hundred eight is modeling all of that PD data and how it relates to the PK work that we have to date. We will go forward and talk to the FDA about how they think about PD data and how we can use that in our 108 program. So that's the path for 108. On 01/2009, while we anticipate seeing, or we would expect to see a PD effect, 109 we're looking to see what the PK looks like at this time, right? So do we see the same rapid absorption of the pro drug?

And do we see the rapid conversion that we anticipate based on our preclinical models? So we'll take both one hundred eight and one hundred nine forward at this time. And then based on our FDA interactions, we'll make a decision on where those two programs go, whether they both go in parallel, whether one goes ahead of the other or whether there are different purposes for the assets and different indications. So we're excited about both and we look forward to talking about them in the second half of the year.

Speaker 8

Great. Thanks for the color guys.

Speaker 0

Thank you. Our next question comes from Shweta Dine with Wedbush. Your line is open.

Speaker 9

Hi, this is Shweta for Liana Moussatos. Thank you for taking our question. For the Libervant NDA resubmission, what

Speaker 10

are

Speaker 9

the steps remaining to refile by end of Q2? And is there any new information that you plan to add to the NDA resubmission?

Speaker 5

Dan? Sure. Good morning, Shweta. So the new information that will be in the NDA, let me put it this way. The most important thing to remember is there is no new clinical data in this NDA.

So this NDA is all of the information from the previous NDA along with our population PK modeling updates. So what we have focused on is, if you look at the CRL from September 2020, as we laid out to all of you, there are a couple of deficiencies that we needed to address. One of those was making sure that we update our safety area in order to talk directly about the patient population, we've done that. The other was to make sure we justified our dosing regimen based on the different weight groups and the performance in our prior 01/14787 study. We've done that.

So that's the data that will go into the resubmission. In terms of the steps between here and the submission in June, at this point, it is an administrative task. We have many of the parts of the NDA already ready to go. The safety part in particular is well on its way. The last piece to put into the NDA will be the final report from our modeler.

And once we have that, the step will simply be sending the NDA into the FDA for resubmission. There's nothing else that we need to do at this point.

Speaker 9

Got it. Thank you.

Speaker 0

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

Speaker 11

Great, thanks. Good morning, guys. A couple of follow ups, I think mostly for Dan. Dan, you mentioned you've continued interacting with the FDA on Libervant since the February guidance. Has anything changed or has it been consistent in terms of what you're required to send in?

Have they added any color? I'm just curious to get some color on those interactions.

Speaker 5

And Thomas, thank you. That's good clarification. The interactions are simply ensuring that we maintain the relationship, specifically with the project manager, letting them know that this is that we will be resubmitting, letting them know that we understand the feedback they've given and making sure that everything is prepared for when that resubmission occurs. So there have been no interactions around the deficiencies or any of the clarifying components that you would that perhaps you're looking for. At this point, it's administrative.

The substantial conversation will occur after resubmission once they have seen our application.

Speaker 11

And then just to follow-up on some clarification you guys made on this call with respect to 109. I think in the prepared comments, you said that part one of the 109 study would be completed in the second half. And just reflecting back on the R and D day, there was a part one ascending dose component, but then there was a part two crossover. So what's the implication for timing on part two there? Is it going to be completed this year?

Or is that something that will be initiated once you've met with FDA?

Speaker 5

Sure. The meeting with the FDA will occur between Part one and Part two, but it is not a gating event. So Part two will continue onward, the preparation, the dosing and the all of the results are on its own track. So I would think about it this way. Part one will read out.

We will take that data. We will go talk to the FDA. And while we're talking to the FDA, the plans for Part two will be underway. We do anticipate at this time that the Part two of our program will begin dosing in 2021. And the final data of when that completes remains to be seen.

Speaker 11

Great. And then just a quick one for Ernie, if I may. On the fourth quarter call, guys mentioned that you would do a $3,000,000 payment. I think it was for Mitsubishi. Yet in the license and royalty number, was less than $3,000,000 Could you just clarify if that payment did come in or how we should understand that?

Speaker 3

Hi. So there's two components to the Mitsubishi Tanabe amount. There is an amount that was based on signing and there is an amount that is based on shipments. And we did receive the cash of $3,000,000 for Mitsubishi Tanabe.

Speaker 11

But that was not reflected in its entirety in the first quarter number?

Speaker 3

That's right. It's not all considered revenue in the first quarter.

Speaker 11

Got it. Thanks so much. Thanks for taking the questions, guys.

Speaker 0

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

Speaker 10

Thanks very much for taking my questions. Can you hear me?

Speaker 2

Yes, Ram. How are doing this morning?

Speaker 10

Pretty good, pretty good. So just to start off with SYMPAZAN kind of learnings as we approach the potential Libervant commercialization. I was wondering if you could comment specifically on what looks like an impressively high retention rate when it comes to repeat prescribers. I think you quoted an 80% rate on that metric for SYMPAZAN script writers. So I was wondering if you could give us some color on whether you expect that repeat prescriber rate to be similar for Libervant as and when Libervant gets to the market.

If you can give us some perspectives on what the experience with SYMPAZANT so far might portend for Libervant, specifically with respect to repeat prescriber rates?

Speaker 2

Ken? Sure.

Speaker 6

Yes, I think what drives the repeat prescriber rate for SYMPAZAN is just the clear patient type or patient profile that benefits from getting their clobazam on a strip rather than tablets or liquids. That's a nice way to position your brand. It creates a clear patient type and that's usually what drives multiple uses in those types of patients. And I would expect the same type of thing with Libervant. And it'll be the only orally delivered rescue medicine.

So it's going to own that space. There's no doubt that orals are preferred over other routes of administration, especially as they get more invasive and more challenging from a drug device standpoint. So I would expect that physicians would adopt and I would expect that the majority, the vast majority would write for multiple patients, multiple scripts for those patients.

Speaker 10

Great, very helpful. So secondly, again on SYMPAZAN, I understand that you're not giving specific SYMPAZAN product revenue guidance, but if you could just qualitatively comment on what you expect the kinetics of the SYMPAZAN revenue growth curve to look like over the course of 2021. Are you anticipating first and foremost sequential quarter over quarter growth going forward as we look towards the remainder of 2021? And then secondly, do you expect that quarter over quarter growth, if indeed you're expecting quarter over quarter growth to accelerate over the course of the remaining quarters of 2021? And to what extent might that be driven by normalization of the overall market conditions relative to the COVID-nineteen pandemic?

Speaker 2

Ram, can you hear me? Yes. Ram, can you hear me?

Speaker 10

Yes, I can hear you.

Speaker 2

We lost the last part of your question. You asked whether we what we viewed or how we were feeling about the sequential growth quarter over quarter. And before I let Ernie answer that, we lost the last part of your question. We'd like to make sure we respond to you. Could you repeat it, please?

Speaker 4

May have lost

Speaker 2

from Ernie, do you want to at least take a crack at the part of the question you can hear?

Speaker 3

Sure, Ram. So again, we don't provide any specific guidance on products. We don't break it out on a full year basis. But I think as we look at SYMPAZAN going through the rest of the year that we would expect quarter over quarter growth as we continue to have the as Ken had mentioned, the in person and face to face meetings with the physicians. And that also is part of our strategy as we prepare for the launch of Libervant.

But this as we've talked about previously that this dovetails with the Libervant launch because of the overlap in the prescribers. So we would continue to expect to see quarter over quarter growth at this point.

Speaker 2

Great. Thanks, Ernie.

Speaker 0

There are no other questions in the queue. I'd like to turn the call back to Keith for any closing remarks.

Speaker 2

Great. Thank you, operator, and thank you, everyone, for joining us this morning. We appreciate your time and your continued interest in Aquestive. Obviously, we're going to be focused on the things that are most important to driving the value of our company. We're going to get we're going to continue to focus on delivering the results out of epinephrine and the trial on 01/2009, as we've described, and then setting up our discussion with the regulators later in the year.

We remain laser focused on finishing out the pieces of work that we need to do to prepare our refiling for the end of the second quarter. We'll continue to grow SYMPAZAN, as Ernie talked about, and we look forward to updating you all on the progress we make on those key items throughout the year. So thank you very much for coming this morning, and we look forward to talking to you all again soon.

Speaker 0

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.