Aquestive Therapeutics (NASDAQ:AQST) Q2 2019 Earnings Call

0:00 Good morning, and welcome to the Equestria Therapeutics second quarter conference call. At this time, all participants are in a list-only mode. Later, there will be a question-and-answer session, and instructions will be given at that time. If anyone requires any assistance on today's call, please press star and zero on your touch-tone telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference, Ms. Lauren Walrath, Head Corporate Marketing and Communications. You may begin. Thank you, Operator. Good morning, and welcome to today's call to review Equestive Therapeutics results for the second quarter 2019 and business highlights, as well as the top line data from the Liberman Crossover Study.

0:49 On today's call, I am joined by Keith Kendall, Chief Executive Officer, and John Maxwell, Chief Financial Officer, who are going to provide an overview of recent business developments and performance in Q2 of this year. Additional members of our leadership team will be available for the Q&A at the end of the call. In total, we expect today's call to last approximately 60 minutes. As a reminder, our remarks today correspond with the earnings release we issued after market closed yesterday. In addition, a recording of today's call will be made available on Equestria Therapeutics' website within the Investor Relations section shortly following the conclusion of the call. To remind you, we will be discussing some non-GAAP financial measures this morning as part of our review of second quarter 2019 results.

1:37 A description of these measures, along with the reconciliation to GAAP, can be found in the earnings release we issued yesterday. 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 included in the company's annual report on Form 10-K filed with the SEC on March 14, 2019 and in our quarterly reports on Form 10-Q. As with any pharmaceutical company with product candidates under development, there are significant risks and uncertainties with respect to our business and the development regulatory approval and commercialization of our products.

2:23 and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All subsequent forward-looking statements attributable to Equestria Therapeutics or any person acting on our 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. Thanks, Lauren. And thanks to everyone on the call for joining us this morning as we discuss a number of important developments in our business during the second quarter and through July.

3:18 John and I are going to walk through some details in our remarks today. and we'll be joined by additional members of the Equestive Leadership Team during the Q&A session afterward. Yesterday we announced positive top line results in the single dose crossover study for LibraVant. This is a critical milestone for our lead asset, which is now positioned to drive significant value for shareholders. This puts us on a clear and straightforward path to completing the filing of our NDA for LibraVant in the fourth quarter. We believe that we've met the specific requirements for approval communicated to us by the FDA, and our product continues to prove that it has attributes lacking in all other current formulations of diazepam.

4:08 In addition, today we'll update you on two other important developments. We continue to build a leadership position in the epilepsy market with the initial entry of Ciprozan. Shipments are up materially to date over Q1 and they continue to trend higher. Second, we completed a deal to refinance our debt in order to reset the repayment schedule and terms and provide additional capital to the company. Let me start by putting our news about the crossover study into context. The progress of LibriVant is truly exciting to us. LibriVant represents a material contribution to improve patient care for the treatment of breakthrough and cluster seizures and will potentially contribute up to $200 to $300 million in peak net revenues within three to four years post-launch.

5:03 Over one million patients in the U.S. have active, uncontrolled epilepsy and a need for rescue medication. Less than 10% of these patients are successfully treating their seizures with the current standard of care A medicine is only as good as its ability to be used by patients, where they need it, when they need it, and in a form they accept. We believe that LibriVant will become the preferred rescue medication by patients and providers looking for an alternative, potentially superior, and clinically differentiated treatment to manage and interrupt seizure clusters. This is based on strong data that shows the product can be quickly and safely applied, results in consistent therapeutic levels, and comes in a form preferred by patients.

5:58 LibriVant is an important late-stage product for our company, and we're excited about where we are in terms of bringing this product to market. In terms of the progression of LibriVant's development and NDA filing, as announced, the first section of the NDA was submitted in May. in accordance with the rolling submission plan committed to the FDA earlier this year. We recently completed the single dose crossover study, which gives us a clear and straightforward path to submission and approval. Top line results indicate we met our primary objectives for the study. Specifically, the study confirmed our dosing model algorithm is appropriate for patients and will support a lower top dose and the top dose of the rectal gel.

6:47 The results also show no difference between the film and the gel in patients using concurrent AED medications. In addition, once again, we observed several patients in the study who did not respond to a dose of the rectal gel, but in those same patients, we were able to produce therapeutic blood levels with Libervant. We are still performing quality reviews and statistical analysis on the data. Once that's complete, we look forward to presenting all the data in a KOL call, and we'll provide more details on the timing of that over the coming weeks. We remain on track to file the next portion of our NDA for LibriVant in September, as planned, and more importantly, to complete the NDA submission in Q4, as expected.

7:40 While we are progressing LibriVan through the approval process, we continue to make progress introducing our technology to payers, prescribers, patients, and caregivers, primarily through our commercialization of Simpazan. Simpazan was launched as our first proprietary product in order to position us in the epilepsy treatment market and help build out our capabilities and relationships in anticipation of launching Complementary Epilepsy-Related Products, most importantly, Librovan. In addition to a differentiated value proposition for patients suffering from Lennox-Gastaut Syndrome, there is a greater than 90% overlap of target prescribers for both Simpazan and Librovan.

8:30 All of our commercialization efforts relating to Simpazan provide an opportunity for direct conversations with healthcare practitioners about the value of our farm film technology in preparation for the eventual launch of LiberVan. Simpazan is tracking in line with our expectations. We believe it can generate approximately $65 million in net revenue at peak within five years. The latest monthly Simpazan shipment volume has grown over 250% since the end of Q1. The prescribing base also continues to grow over 125% since Q1, with over 80% of those prescribers writing multiple scripts and a refill rate approaching 65%.

9:22 This continues to track favorably with the analogs we use for uptake and refills Phycompa Liquid, and Amphi, respectively. Additional contracts with payers and PBMs were signed since the first quarter, and we continue to expect to achieve our goal of having over 70% of lives covered by the end of the year. We're happy with these trends. Simpazan is strategically accomplishing what we want it to, and these efforts will not only continue to contribute to our growing cash flow, but more importantly, establish the foundation ahead of a Libervant launch. The last key deliverable for the quarter was to refinance our existing debt facility. In this regard, we successfully completed our debt refinancing in mid-July with Madron Asset Management and others that provides up to $100 million to our business, including $70 million up front and up to $30 million This was important for a number of reasons.

10:32 It allowed us to pay off our existing line with perceptive, eliminating near term principal repayments, including a $38 million bullet payment in 2020. It also provided an immediate injection of $15 million of incremental capital. and the deal provides for additional capital of up to $30 million between now and March of 2021 based on the satisfaction of certain conditions which were described in our Form 8-K filed on July 15, 2019. We believe these funds together with product revenues and the potential monetization of our royalty position in Synovian's Apomorphine product following its FDA approval can provide the capital we need ahead of the expected liver band launch.

11:24 Beyond the key goals, Suboxone is performing very well against the generic films that have launched at risk. Suboxone and the authorized generic, which we produce, still hold a very strong position of over 75% share of the film market. Our order book remains strong. As such, we are amending our guidance upward and narrowing the range for Suboxone. We now expect to produce between 240 and 260 million strips and generate between $29 and $32 million of revenue from Suboxone in 2019. While this represents the legacy part of our business, Suboxone continues to be an important source of revenue and Cashflow and will contribute at a higher rate than originally expected for the remainder of the year.

12:20 Additionally, the epinephrine or Equestive 108 Phase 1 Proof of Concept Clinical Trial continues in Canada and we're on track to complete it in the third quarter. Based on the data, once available, we would expect to move to a pre-IND meeting with the FDA as quickly as possible. In the event the data indicates some modifications to our formulation might be needed to reach certain PK performance goals, we'll move immediately to start that work and conduct additional proof of concept studies. Finally, Exurban, our Rilazole-based product for ALS, also continues to move toward a November 30th PDUFA date. As we have said previously, we are seeking to license the product outside the United States. and we have begun the process of identifying potential commercial partners in the U.S. as well.

13:18 This was an important quarter for us and we made a lot of progress on key value drivers. The LibraVant study has successfully concluded and we're on track to complete the NDA filing in Q4. Simpazan continues to grow and is establishing strategic relationships for us in the epilepsy market in advance of a LibraVant launch. We've improved the company's capital position and now have potential access to additional capital. And based on the current strong performance of Suboxone, we'll continue to see strong revenues through the end of 2019. We look forward to continuing to deliver on these activities in the third quarter and through the rest of the year.

14:03 I'll now turn the line over to John Maxwell, who will provide additional specifics around the debt refinancing and other aspects of our financial performance. Thank you, Keith. Good morning, everyone. I will start by highlighting a few key items. One, our improved capital position in 2019 revenue outlook. Also, a gross margin revision that is solely a consequence of a shift in revenue mix and does not reflect any changes to the profitability of a proprietary or licensed products and a higher 2019 spend than previously anticipated. As Keith noted, we made substantial progress on our capital plans, eliminating debt repayment requirements in the near term and providing access to additional capital.

14:49 The total facility for up to $100 million provided $15 million of new capital up front, pushed out repayment of principal until late 2021, and provides up to $30 million of additional capital subject to the satisfaction of certain conditions, including $10 million at the filing of the Libervant NDA expected in Q4, subject to approval of note holders, and $20 million upon Libervant's FDA approval, which is expected in 2020. As part of the deal, we issued 2 million warrants for our common stock to institutional note holders. Pursuant to the indenture, we will be registering these warrants as well as affiliate shares in a universal shelf registration in September.

15:37 As you know, we do plan to monetize the apomorphine royalty stream once that product is approved, which is currently expected to be in early to mid 2020. As we have noted previously, this royalty stream could provide additional capital of up to $100 million or so. At the time of any apomorphine monetization, note holders will have the option to buy down debt with up to $50 million of the proceeds, potentially leaving us with substantial new cash and a reduced debt balance. By now, you will have seen our financial results in our 10Q and earnings release that were filed yesterday. I want to draw out a few points that are important to an understanding of our updated 2019 financial guidance published in the release.

16:23 To the extent that there are questions on the Q2 results, we can take those during the Q&A session. First, Suboxone performance remains strong and we are changing our Suboxone revenue outlook as a result. In the second quarter of 2019, we produced 72 million doses of Suboxone and the authorized generic product. This production level was comparable to the second quarter of 2018 production of 74 million doses. As Keith mentioned, Suboxone products hold about a 75% share of the film market. As such, we continue to see strong manufacturing purchase orders for Suboxone and the Sandoz authorized generic product. Based on the franchise's market performance in our order book, we are updating our full year guidance for Suboxone manufacturing volume to a range of 240 to 260 million doses up from previous guidance of 190 to 240 million doses. We feel good about our product's market performance to date and we will continue to evaluate the market performance of Indivior and Sandoz and we'll update the market again in our Q3 call.

17:35 The consequences of this is that we are raising our guidance on manufacture and supply revenue to be in the range of $29 to $32 million, up from $23 to $30 million, and we are raising the bottom end of our 2019 total revenue guidance up from $33 million to $38 million. This brings our total revenue guidance range to between $38 million and $45 million. The revision would have been higher, except that we removed the $4 million apomorphine approval milestone out of 2019 and into 2020. We are assuming Synovian resubmits in Q3 2019, as it has publicly stated it will do, and we are taking a conservative view that the Bidoof O'clock will be six months, not two months.

18:28 With the shift in revenue mix, which now reflects a higher proportion of Suboxone products instead of 100% margin from license payments. We are adjusting our guidance on full year non-GAAP gross margin to a range of 67 to 69%. Second quarter 2019 adjusted gross margin was approximately 57%, reflecting that there were no milestones within the quarter But the full year, of course, does include some milestone in royalty revenue that drives our gross margin to be higher in total on the year. The other factor in our margins is that Simpazan, which carries a relatively higher margin to other products, will be an increasing portion of our total revenue in the future. Our updated guidance captures these various elements.

19:17 As outlined in the earnings release issued yesterday, our full-year non-GAAP adjusted EBITDA loss range has been revised to $50 to $52 million from our previous guidance. The new guidance reflects the revenue mix shift and its impact on gross profit, as well as some additional expenditures made related to protecting our IP in the face of the generics in the market at risk, accelerating the LiberBank crossover trial, and other general business activities in the first half of the year. At the same time, interest costs will increase in the second half as a result of the higher debt amount outstanding. We're increasing our cash burn guidance to approximately $60 to $65 million, tracking with a revised revenue, gross margin and EBITDA guidance, additional financing costs based on the timing of our refi, plus some working capital effects.

20:12 In summary, our spend reflects investment in a future of high-value proprietary assets, including a dominant position in the epilepsy market. Our capital position has been improved, our debt payments have been pushed out well beyond the expected Librevent launch, and our revenue continues to be strong from our proprietary and licensed products. And we have visibility on the apomorphine royalty stream, which we expect to provide significant new capital in the first half of 2020. Operator, we will now open the line for questions. Thank you. Ladies and gentlemen, if you wish to ask a question at this time, please press star then 1 on your touch-tone telephone. If your question has been answered or you wish to move yourself from the queue, please press the pound key.

20:57 To prevent any background noise, we ask that you please place your line on mute once your question has been stated. Our first question comes from Gary Nachman with BMO Capital Markets. Your line is open. Hi. Good morning. It's for Gary. Good morning. For LibriVent, how soon could you launch after an approval, and how should we think about the competitive landscape at launch? How much of a potential threat is UCB's nasal aim that was recently approved? Sure. So this is Keith responding. We'll be preparing to launch once we have visibility into the PDUFA date, as quickly after the PDUFA date as possible. The UCB product has not yet actually hit the market.

21:44 We don't know what kind of traction they'll have, but we've always anticipated that we would enter the market with, A, if not multiple competitors, and we're prepared to deal with that based on what we believe is a very strong value proposition for Libervanth. Thanks. And then for Simpavan, can you provide some color on the assumptions behind your peak sales forecast of $65 million? What kind of penetration and gross tenets does that assume? Sure. The gross-to-nets are consistent with what we're seeing now and what we've talked about publicly about the gross-to-nets for that product, and we'll continue that out. The penetration is relatively modest. I don't recall the exact number, but it's probably very low double digits overall in that market.

22:43 and we ramp it to that number over that period of time based on some of the analogs we've seen in the market and what their performance was at launch. Thank you. Thank you. Our next question comes from Randall Stanicki with RBC Capital Markets. Your line is open. Hi, good morning. This is Ashley Ryu. I'm for Randall. Hi. Hi. It sounds like there's some good momentum building behind Simpavan. And could you talk a little bit more? I know you said that the growth curve is going to be kind of analogous to some of the products that have already been on market. But could you kind of talk about the growth curve in terms of should we kind of expect this level of growth to continue and then more accelerate once you start onboarding more reps for Libervan, giving the high prescriber overlap? And are you starting to see, I guess, that acceleration from the removal of new-to-market blocks yet?

23:43 Sure. I'm going to turn it over to Ken Marshall, our Chief Commercial Officer, to respond to that. Great. Hi, Ashley. How are you this morning? Hi. Welcome. Yeah, the new-to-market blocks coming off is when you normally see volume pick up with products. Keep in mind that this isn't a typical pharmaceutical market. These are very fragile patients. They make change very methodically. Once they make change, they tend to stick with it for longer periods of time than normal medicines. But you do see volumes of our shipments picking up in the July timeframe, and that's about the time you're seeing these new market blocks come off. So, yes, you should see some improvement there. If you're looking at coverage, as you expand down our sales force in anticipation of LibraBand, we certainly will and Frank Lopez.

24:44 Got it. And you guys have said that you're expecting 70% to 75% covered lives by year end. What are you at right now? Yeah, if you look at the MMIT audit, which is probably the industry standard to assess these types of things, overall 47%. The coverage in our two key segments, commercial and Medicaid, are almost equal at that number. So we're well on our way. We've got a couple of contracts in red line right now. If those come through, we actually might hit that a little earlier. Okay, got it. Okay, thanks so much. Thank you. Our next question comes from Leanna Mosato with Web Bush Securities. Your line is open. Thank you for taking my question. Your guidance of $38 to $45 million in total revenues minus $29 to $32 for sub-oxone and generic, what's the remaining $6 to $16 million?

25:41 Sure, Liana. Good morning. We have four components in our revenue, manufacture and supply, which Suboxone guidance will make up the majority of that number. We have license fees and royalties, which we've made about $5.5 million to date and would expect the second half of the year, because we've moved apomorphine out, to be a relatively smaller number. We have co-development fees which continue on a normal course. We have, you know, activity with a few different potential licensees. And that number will remain in the range of where it is. And then SEMPAZAN would be the remaining piece of our total revenue picture. Thank you.

26:28 Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open. Hi. It's going for Jason. Thanks for taking our questions. I had a quick one, Keith. You kind of mentioned it, I think, but in the crossover trial for LibraVant, we had about a 10% failure rate on the rectal gel. Is that consistent with real-world use? And it sounds like it was due to poor bioavailability. There were no other problems with the dosing? The dose was correctly delivered? Sure. I'm going to let Dr. Gary Slatko, our chief medical officer, grab that because the technical nature, that's beyond my pay grade. Thank you. Good morning. So the non-responders in the diets in the rectal gel group all occurred in the highest weight group, the 20 milligram group, which was the highest dose group in the study.

27:23 That dose is higher than the maximum dose of This is consistent. This incidence rate is consistent with what we've seen in previous studies in our experience. It's also generally consistent with what's been reported in the literature. The event rate in literature studies ranges anywhere from 3% to 18%. So the average of that is roughly 12%, which is consistent with what we're seeing here. Okay, great. And then a couple on the Simpazan launch.

28:08 It's early in the launch, obviously, but any plans for adjustments to the selling efforts or new initiatives? And then how many of the target prescribers have written a prescription? And what was the return rate for the quarter? Thanks. Yeah, so as far as adjustments, I think we're right on target with our messaging. So that's going to stay as is. We will dial up our presence with caregivers. After you've made a few rounds with physicians, it's very appropriate to start talking more to the caregivers and the higher functioning patients if that's reasonable. It's a nice way to accelerate your business. If you look at the numbers of physicians who've written, That's approaching nearly 10% of our core positions and 5% of our overall targets.

29:03 We'll approach 300 writers by the end of this month. Okay. Great. Thank you. And the return rate for the quarter, do you know that? It's virtually nothing. and nothing has ultimately come back. Sometimes there are returns from the wholesalers. Oh, returns. I'm sorry. To the wholesalers, but we haven't seen returns. Yeah, we have no returns. There's some restocking, as there are always with specialty brands, when it goes to pharmacies and isn't picked up, but we have no returns. It will come back. I would assume that's a good question. Okay. Thank you. Thank you. Our next question comes from Thomas Flatton with Lake Street Capital. Your line is open.

29:49 Thank you. Good morning, guys. A quick question for John. What was the GTN in the second quarter? The second quarter gross to net was in the mid-40s. I'm sorry, I'll get the exact number for you. I don't remember it, but it's in the mid-47%. Sorry, John. No, go ahead. Just a couple questions on the Liberman study. I noticed in the press release the Tmax description didn't have a comp to diastat. Were they similar? Can we infer that from meeting the endpoints? Right. So this is Gary. So the Tmax for diastat is consistent with the diastat label.

30:36 So there's no surprises in terms of how diastat performs. The T-max for the film was, despite being in a fed patient population, was consistent with what we've seen in healthy subjects who were fasting. So it was actually a little bit faster than what we might have expected. Great. And then from a submission and labeling perspective, Is this going to be weight-dependent dosing? And I'm just curious how the dosing administration section is going to look or what you're going to submit to FDA. Right. So the way the study was designed was based on a weight-based algorithm, which is consistent with how the rectal gel is administered. Our dosing is slightly different, but it is based on A different dose for different categories of weight. And when we administered in this study according to the dose according to those different weight groups, the concentration of diazepam that was achieved across the different weight groups was relatively consistent, which was to us confirmation that the algorithm is doing what it was intended to do.

32:03 Excellent. That's great. John, one more for you. On the death facility with the incremental up to $10 million that you can pull down on LibraVant submission, just mechanically, is that on acceptance to file? Is there a time lag in how long it will take you to get that money? Just can you explain the mechanics around that a little bit? Sure. There's a couple of important mechanics. One is it's on filing. It isn't on acceptance, so we would expect to be able to access that in Q4. We do need... Excellent. Thanks so much. Excellent. Thank you. Sure. Thank you. Once again, ladies and gentlemen, if you wish to ask a question at this time, please press star then 1 on your touchstone telephone.

33:00 Our next question comes from Ram Silvaraju with HC Wainwright. Your line is open. Good morning, everyone. This is Edward on for Ram. I appreciate you taking the question. Just a few left over from me. You were talking about the, or there's a mention of that 10% rectal gel treated subjects failing to achieve the adequate exposure. Considering this is what is seen in I was wondering how important this was for labeling and for approval. Well, in our discussions with FDA, we designed the protocol in consultation with them, and our design and analysis included the plan to include designed the study as a real-world study, the real-world conditions, which included patients who were getting concurrent meds, if patients were getting rectal gel, they were not pretreated with an enema, so they were under real-world conditions, and patients who were fed, which is more likely how patients would appear when they were being treated with film or gel.

34:22 So we believe we've replicated with the study the real-world conditions that we will be treating patients under, and that should be reflected in how the labeling reads. Okay, that makes sense. And then a couple around just the design and the results. It looks like about 3 out of 31 patients were excluded from the primary analysis, just wondering why they were excluded. Looking at the overall amount of data, I was wondering if the FDA would have any additional remaining questions about the film versus the gel. I just wanted to ask about that, that you're going through the remaining filing for the NDA and whether that's part of what might be in that September submission or if you believe that you have not only all the clinical data, as you mentioned in the press release, but you have all the background manufacturing data as well for that NDA.

35:18 Sure. So regarding your first question, Of the 31 patients, two experienced adverse events that were considered not related to the medication administration. So those patients were discontinued and were not able to complete both arms of the crossover. So we were not able to use them in the primary analysis. The third patient was excluded because they did not meet a protocol requirement of having a low diazepam level at the time they were to be started on the next arm of the trial. So they were disqualified for that reason.

36:05 In terms of the second question, we plan to do secondary analyses In addition to completing the statistic QA and statistical analysis on the primary data, we are planning to do secondary analyses that we will be sharing at the KOL day to be scheduled in the fall. Additional information we anticipate sharing at the time would be information around the time course to different diazepam concentrations that we're comparing film to gel. and we will also talk about additional analysis of a meaningful subset of patients who were exposed to a high-fat diet in anticipation of potential questions that we may get from FDA around that population.

36:58 Those are the questions that we would anticipate potentially getting from FDA. We believe the study has answered all the other outstanding questions that the FDA would have. and Edward, this is Keith. I'm going to let Dan Barber give you a little more color on the regulatory part of your question, okay? Yeah, and good morning. Just to add on to Gary's clinical analysis, from a CMC perspective, we remain on track for putting that portion in on September 30th like we've guided before. We don't see any obstacles to submitting that piece. and there are no additional clinical studies that we plan on performing prior to our NDA submission.

37:48 So all of the work to get to filing at this point is in our four walls. Excellent. Yeah, I just wanted to make sure that everything was still tracking along with your guidance. So I appreciate all that color. Two more quick questions that might be able to answer really quick. Are you providing any guidance on SimPlan Revenants for 2019? No, we are not. I mean, we just got out of new-to-market blocks. We've just crossed the threshold with a number of new PBM contracts that are significant. We've got to see how that progresses, and then we'll evaluate later in the year, but we don't plan to provide guidance at this time. Yeah, that makes sense. And then just looking at Suboxone really quick, just wondering if there's going to be any resolution on the litigation that you've heard about at least and maybe some podcasts that you can talk about.

38:44 It looks like you're raising your guidance so things are looking up, but just wondering what you're seeing in the future. This is Keith. I think questions about the litigation are best directed to Indivior. We don't have visibility into their litigation strategy at this point in time. We continue to see a very strong market. We continue to see very strong performance of both the brand and the authorized generics. both of which we're the exclusive providers of. We'll continue to enjoy that strength for as long as we have visibility into it, and we'll react to the different litigation components as they become visible to us. But in terms of strategy and expectations, that's a question best directed to Indivior.

39:36 Okay. Well, that's all for me. I appreciate you guys taking all the questions. Congrats on the updated quarter. Thank you. Thank you. And I'm sure no further questions at this time. I will turn the call back over to Keith Kendall for closing remarks. Thank you, Operator. Well, thank you, everyone, for joining today's call. Obviously, we're very excited about the significant progress that our team has made over the last couple of months, and we look forward to continuing to deliver in the third quarter. and remaining focused on the successful conclusion of the epinephrine trial that is ongoing right now in Canada, continuing to develop Simpazan and Inquestive's position in the epilepsy market, and obviously, most importantly, to continue to progress LibriVant toward its ultimate filing in Q4. So thank you all for joining, and we'll look forward to talking again soon.

40:33 Ladies and gentlemen, this concludes today's conference. Thank you for joining and everyone have a wonderful day.