Impel Pharmaceuticals Inc.
Q3 2021 Earnings Call Transcript

Published: 15 Nov 2021

[Operator:]

Good morning, ladies and gentlemen. And welcome to the Impel NeuroPharma's Third Quarter 2021 Earnings and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. . As a reminder, this conference call is being recorded. Now I would now like to turn the conference over to Impel's Chief Financial Officer, John Leaman.

[John Leaman:]

Thank you, Gail and good morning, everyone. We're delighted that you can join us today for Impel NeuroPharma's Quarterly Earnings Conference Call, during which we will review our Third Quarter 2021 Financial Results, as well as providing general corporate update. Joining me from Impel this morning is Adrian Adams, Impel's Chairman of the Board and Chief Executive Officer; and Leon Paolillo, our Chief Commercial Officer. Before we begin, I would like to remind everyone that we have a slide presentation to accompany our conference call this morning, which can be viewed at our website at www.impelnp.com. If you're listening to this call on your telephone, you may access a synchronized slide deck on our website by choosing the link on the Webcast page that says Click Here to Listen. Read the Slide 2, I'd also like to remind you, that during this call, the Company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. With that, I will turn the call over to Adrian Adams. Adrian?

[Adrian Adams:]

Thank you, John, and good morning, everyone. And thank you for joining us. I am both grateful and indeed excited to update you all the progress we've made since our quarter two earnings call. Because I'm pleased to say we've achieved a number of significant milestones over the past few months. On this next slide, slide number three, you will find the agenda for this morning's call. The focus of today's call is to review the launch progress of TRUDHESA including the early launch performance indicators within the large rapidly growing and dynamic acute migraine market. Given this is only our second quarterly earnings teleconference, I will start off by providing a brief reminder of the investment opportunities with Impel before covering the results of our commercial launch efforts with TRUDHESA. I’ll then return the call over to John, to review our third quarter financial results in detail. I will then close by briefly touching on the clinical development status of INP105 and summarizing our year-to-date progress against the corporate goals we set for the beginning of this year, before opening the call up to your value questions. Turning now to our next slide, Slide number four. For those on the line who may be new to Impel, on this slide, I would like to take a moment to highlight a few of the key value drivers that we believe position the company the growth and success in the short, medium and long-term. First, the recent FDA approval of our first product TRUDHESA for the acute treatments of migraine headaches with or without or in adults has opened up a large and growing market opportunity for Impel with significant revenue potential. The commercial launch of TRUDHESA in early October is focused around a highly targeted goal to market strategy involving a 60-person salesforce targeting 8,000 high prescribing physicians with a heavy emphasis on neurologist. The clinical development program for our new release product candidate INP105, which is being evaluated the acute treatment of agitation and aggression in autism is also progressing. In fact, our Phase 2a Proof-of-Concept trial known as the CALM 201 study is planned to be initiated in the late quarter four 2021 timeframe. Finally, we believe that Impel NeuroPharma's proprietary POD technology, and its unique approach to targeting the upper nasal space has the potential to truly transform clinical outcomes, not only for patients in the CNS area, but also in many other disease areas. Given this ability to deliver rapid and consistent relief of symptoms with injection like efficacy, for doing this in a non-invasive convenient way. Please now refer to our next slide, Slide number five. We will turn to the details of our targeted commercial launch activities and strategy with TRUDHESA. The commercial launch of TRUDHESA is indeed off to a fast start, as we continue to execute well against all key commercial priorities. The third quarter was a busy one, as we hired, trained and deployed or 60 neurologist sales specialists. The team is motivated by a mission to help patients still searching for predictable and consistent efficacy, despite the many new options. We've also put in place a performance aligned incentive scheme to reward them for strong sales achievement. Complementing our sales efforts, we have trained 75 key opinion leader speakers to deliver peer-to-peer education events covering the TRUDHESA clinical data, as well as its place in therapy. Additionally, our targeted, digital directed consumer activity are started and will increase its volume throughout quarter four and well into 2022. We’re also pleased with our market access progress. Indeed, pair discussions are progressing according to plan and the performance of our TRUDHESA Direct pharmacy partnership bridge Program is above expectations, importantly, with low abandonment rates, which in turn signals high patient satisfaction. You'll see on our next slide, Slide number six, that we have become executing a very targeted approach in entering this large and competitive acute migraine market. I would like to remind you that at the end of 2020, there were 27 million prescriptions written in this market, an impressive growth of 15% year-over-year. This growth is being driven by the non-trips and segments of the market and in large part by the neurologist community. All commercial strategy is focused on a concentrated prescriber base, which allows the coverage of 35% of the market. The 8,000 physicians we are targeting are comprised of around 5,500 neurologists, and 2,500 high prescribing primary care physicians. Importantly, these target physicians prescribe 60% of acute branded prescriptions, and 65% of all DHE prescriptions. To provide an early perspective that how this smart targeted approach to commercialization is leading to prescription productivity. I would like to turn to our next slide. Slide number seven. Symphony Health dates are shown here provides a view of all first four weeks of launch. This show strong week-over-week growth in both prescriptions and indeed prescribers. Our all internal pharmacy data shows approximately 250 prescribers as of October 31, given an average of 2.5 through data prescriptions per prescriber. Not surprisingly, and indeed pleasingly 83% of all prescribers are targets of our sales efforts. With around 660 prescriptions in just the first four weeks of launch, TRUDHESA has clearly gained the attention of physicians, and the TRUDHESA target direct pharmacy partnership has provided a streamlined experience to patients. On this next slide, Slide number eight. We are pleased with the growth and prescriptions in both our target prescribers and by how these prescribers are writing. Our launch efforts have a two pronged process. The first is on generating immediate uptake and prescribing, and the second is on creating depth and breadth of current prescribers. Our progress in both areas is highly encouraging. While we expected to have a high number of prescribers to be within our super targets and targets, we are pleased to see early prescribing trends among these to our non-targets. It is also encouraging to see we have a subset of prescribers that have already written more than six or even 11 plus prescriptions. As you can see on this Slide, it shows our efforts of making patients aware of TRUDHESA is paying off. On our next slide, slide number nine, it is clear that prescription show within our super targets provides quantitative signals that TRUDHESA will hold a significant place in physician’s treatment mountain terrarium. We are using a simple data help, new to brand data here due to the early stage of our launch where refills are minimal, but also believe is a leading indicator for future growth. The final week in October short that TRUDHESA is already capturing 2.4% of the new to brand market after only four weeks on market. This is very encouraging. Our super targets prescribe around about 60,000 branded acute prescriptions for new patients per quarter. This is 34% of the total acute branded new patient start market and represents the foundation for TRUDHESA prescription growth in the future. I'd now like to turn to Slide number 10. On this slide, we are illustrating the utilization of progressive among early prescribers. It is exciting to see that around 14% of the new patient starts are already going to TRUDHESA. As this is only our first month of launch, this already shows competitive success, and compares favorably to Nurtec and Ubrelvy in new patient shares. This illustrates not only the remaining need for efficacy in the acute treatment landscape, but the view that DAT and more specifically TRUDHESA can fill that search for efficacy. This very much speaks to the evolving potential for TRUDHESA in this large market, and importantly, in the post triptan failure market. We are very encouraged by the early receptivity TRUDHESA has received among prescribers to-date, and these early metrics give us confidence about the brand's short, medium, and long-term potential. Turning now to our next slide, Slide number 11. I would like to summarize the early performance trends and quarter four expectations with TRUDHESA. As we’ve reviewed, although early in the launch, the first month of launch has exceeded our expectations, we are pleased that the core tactics associated with our fundamental targeted launch are playing out as anticipated. Sales force execution is being both productive and successful as manifest in terms of strong we prescription trends and growth in terms of both the number and depth of prescribing with neurologists in particular. We anticipate based on the strong start that we will finish the year with around 750 unique prescribers and a prescription base of between three to 4000 prescriptions. In addition, based on the status of contract discussions with key managed care, we expect to exit this year with around 40% coverage of commercial lives. This performance base with TRUDHESA will put us in a strong position for 2022 and the year which will at a minimum be in line with analyst expectations. With that, I will now turn the call over to John to review our financial results for the third quarter.

[John Leaman:]

Thank you Adrian. Our next slide, Slide number 12, you will see our financial results for the third quarter of 2021. The net product revenue for the third quarter 2021 was $0.1 million, initial shipments of TRUDHESA to specialty pharmacies began in September of 2021 ahead of our October commercial launch. Research and development expenses for the third quarter of 2021 were $5.9 million for third quarter 2021 compared to $6.1 million for the same period in 2020. The decrease was primarily due to the decrease in TRUDHESA clinical expenses, as the Phase 3 study was closed, Selling general and administrative expenses for the third quarter of 2021 were $16.3 million, which compares with $2.9 million for the third quarter of 2020. The increase in SG&A was primarily due to the ramp up in spending to support the commercial and marketing preparation for the TRUDHESA launch. For the third quarter of 2021, Impel reported a net loss of $25 million or $1.24 per common share, compared to a net loss of $9.2 million, or $15.56 per common share for the same period in 2020. Please turn to the next slide, Slide number 13. As of September 30 2021, the company had cash and cash equivalents of $111.3 million. In July, the company completed a $50 million debt financing, $30 million funded during the third quarter of 2021 and repaid the avenue term loan of $10.9 million including prepayment fee. Further we have $20 million available to be used at the company's discretion upon meeting certain revenue milestones. In September, the company completed a follow-on public offering resulting in net proceeds of $48.3 million. We believe we have sufficient financial resources given the debt net equity financing to fund the operations into 2023. With that I will now turn the call back over to Adrian to make some closing remarks. Adrian?

[Adrian Adams:]

Thank you, John. Before closing out, I did want to make a few remarks on the development status with INP105, I would like to turn your attention to this slide, Slide number 14. Firstly, I would like to underscore the broad clinical possibilities that we see with our POD technology platform. We are clearly pleased with the recent approval of TRUDHESA and pursuant to this, we believe that the POD technology has the potential to deliver numerous additional therapeutics, for which the next in line for Impel is indeed INP105. To remind everyone INP105 is comprised of a powder formulation of olanzapine, which is the most used treatment for acute agitation and aggression, what its use is currently limited to intramuscular injection. We believe that INP105 has the potential to significantly reduce emergency room visits for patients with autism spectrum disorder. We have uncovered this as being a major unmet need as there are at least 220,000 emergency room visits a year, a large majority of which relate to patients that cannot be controlled in the home setting. Therefore, there is a significant market opportunity to bring a more humane approach to de-escalating agitation and aggression episodes in the autism patient population. The Phase 1 results -- study results of INP105 in healthy adults, shown on this slide were published in the Journal of Clinical Psychiatry last year. The findings demonstrated that INP105 reached peak plasma levels approximately twice as fast as intramuscular olanzapine, currently marketed Zyprexa and 10x faster than orally disintegrating tablets. An ideal desired medication for acute agitation and aggression in autism is easy to administer, provides rapid tranquilization without excessive sedation as a swift onset of action with sufficient duration to prevent untimely recurrence and has low risk for adverse events and drug interactions. This is the goal with INP105. We are delighted to confirm that we are on schedule to initiate a Phase 2 proof-of-concept study towards the end of the fourth quarter. Turning now to our final slide, Slide number 15. This continues to be an exciting and transformative time for Impel, given the excellent progress we have made this year not only achieving but exceeding the objectives and milestones we articulated at the beginning of 2021. These milestones as you can see through the completion of the initial public offering and successful following offerings, as well as the FDA approval and commercial launch of our first product TRUDHESA, transitioning Impel into a commercial company. We are looking forward to initiate the Phase 2 proof-of-concept study with INP105 in the fourth quarter, and to completing what has been a transformational year for Impel. With that, I’d now like to open the call up your value questions. Operator, can you please give the instructions?

[Operator:]

Your first question comes from the line of Ken Cacciatore from Cowen, your line is open.

[Ken Cacciatore:]

Hey, Team, I have a few congratulations on all the initial progress. So I just want to start with managed care and you talked about having 40% covered lives as we exit which is fantastic. But wanted to drill down a little bit to talk about the net pricing that you're hoping for how those initial discussions are going, we see Nurtec and Ubrelvy settling in around 500 net to the company. And so just wondering if you could give a little bit of commentary around how those discussions are progressing and how we should think about when we get to normalization, what that might look like? And then also really intrigued and appreciate the commentary around the view into 2022. There is a large range from just a few analysts that are following you. And I think consensus shakes out in that range around $50 million. So wondering if you could just speak to it with a little bit more specificity? That was question number two and I have a couple follow-ups, but I’ll stop there and like you answer those. Thanks.

[Adrian Adams:]

Thank you very much, Ken. I think I'll ask Leon to comment in a moment. But you're right. I think as you may recall, I think during the kind of May, June and July timeframe we invested in market access strategy professionals. That was with a view to having clinical data exchange with those groups, for the very aim of making sure that we could actually transition into the larger into the fourth quarter with a strong building growth of commercial lives coverage. So in essence by the middle of next year, we anticipate 70% to 75% of commercial lives being covered. So clearly, I think we've been making some very good progress on the specifics of how those discussions are going particularly as it relates to the actual contracts. I'm going to ask, Leon to comments on that. Leon?

[Leonard Paolillo:]

Sure. Thanks, Adrian. And Thanks, Ken. So they're progressing exactly as we thought they would. I think one of the great things is when where the company sees TRUDHESA position, which is firmly after Triptan, and you think about where the plans want to put into utilization management, we see good alignment there. So that big hurdle is kind of something that we get through pretty well with the plans when they look at the clinical data for TRUDHESA. And at this point, it's, as you expect, we're in the final stages of discussions on contracts with the large PBMs and then pulling that through to the local plan. So at this stage, the conversations have gone very well. They understand the clinical data, thanks to our medical affairs and market access colleagues doing the work ahead of launch. And we're in contract review with a number of the major PBMs right now. And to your second question, John, maybe you can just broadly comment on our aspirations for next year. We are very pleased with the progress today. And clearly, I think, we believe at a minimum, we're going to be in line with the other expectations. But John, maybe you can comment.

[John Leaman:]

Yes, Ken. And thanks for the comment. I think to your question, as Adrian mentioned, I think we're very pleased with how the launch has gone. And I think the script that he mentioned towards doing it for 2021 will lead us to hit those expectations that we're hoping to hit in 2022. When we look at the analysts that expectations for 2022, that there's sort of a broad range, yourself, Guggenheim and Wedbush. I think as we think about, what the range looks like for net revenue as we go into that year, we will be within the range of that, I think on the low end, and there's a couple who are on the high end. And I think we think about it, targeting, I think you know, how you've laid out 2022 and 2023 is in line with what we're hoping to do in the coming year.

[Ken Cacciatore:]

Okay, that's helpful. And then maybe just a couple other just further questions on spending. Just wondering, as we go into 2022, and we're looking into Q4. Should we think of a slight step up into Q4, or is Q3 a good run rate and as we kind of look forward into 2022, and then a broader question, understanding that you certainly want to secure managed care before you get a little bit more aggressive on promotion. But wondering if DTC is in the future at any point later next year, obviously, that's great to activate patients, it certainly can also help with your effort to activate clinicians? And so just wondering, any thoughts, and I'll leave it there. Thanks so much, and congratulations again on the progress.

[Adrian Adams:]

Thank you, Ken, I'll ask John in a moment to comment on the aspects of spend. To your second point, I think you're quite right. I think clearly, we've seen the power in the marketplace on direct-to-consumer advertising, et cetera. We are delighted that's been driving a tremendous amounts of growth within the migrant market. I think, as you also know, I think we've always stressed I think, a very financially disciplined and importantly, targeted approach to our commercialization. So as we progress into 2022, we’ll increase our activity in relation to kind of digital work and direct-to-consumer broad kind of digital advertising. And we based on performance we anticipate that 2022 is going to be a strong year based on that performance, there are two things that obviously, we're going to be keeping a very close eye on. One is indeed, whether or not there is an opportunity to broaden the awareness and consequent generation of prescriptions with the broader utility of direct-to-consumer vehicles. But also, as we've articulated before, we are planning to invest into the opportunity and with a view to doubling the size of our salesforce as we move into 2022. All of this clearly, is going to be dictated by what we anticipate as being a strong first half of next year. So financial discipline, very targeted, looking in particular to build a very strong base of utility and endorsement by neurologist and then broaden it out and earning the rights and the ability to be able to do more extensive promotion and direct-to-consumer activity. John, maybe you can comment on the spend levels.

[John Leaman:]

Ken, I think to your question, I think the third quarter is probably a pretty good caveat as we move forward into the fourth quarter and then into 2022. I think obviously, we were ramping up for basically the salesforce and to get ready to go out and launch TRUDHESA. And so I think it's a very good sort of that number is a very good one carrying forward into the next couple of quarters.

[Ken Cacciatore:]

Great. Thanks again.

[Operator:]

Your next question comes from the line of Eddie Hickman from Guggenheim Securities. Your line is open.

[Eddie Hickman:]

Hi, good morning, guys. Thanks for taking my question. And congrats on the launch so far. Couple for me. When you're showing here that in so the current four weeks for TRUDHESA, you're getting almost 14% of the of the new-to-brand starts. Given your sort of guidance for 2022 within the analysts range and three to 4,000 scripts, like what percentage sort of target does that? Does that indicate within sort of that new-to-brand starts within the competitors? And then sort of what are you looking for in 2022, that would sort of make you decide whether and when to ramp up your Salesforce and sort of what how much would that cost and when? Thanks.

[Adrian Adams:]

Yes, I am going to ask Leon to comment. We're pleased that obviously you noted that data and clearly whilst it's relatively early days, and looking at the kind of share evolution, this is amongst, obviously TRUDHESA prescribers. So we're very -- as you well know, I think we've had quite a number of discussions over the course of time as where we saw TRUDHESA fitting in the element area and physicians. And we always said TRUDHESA should be placed post triptan failure, and competing directly with the Ubrelvy and Nurtec. And clearly, this early data gives us kind of optimism, and indeed the excitement around the kind of shows we're already generating. And clearly over the course of the next number of months, we're going to kind of see a lot of different dynamics going on. But this is very encouraging data so far. Leon, do you want to answer that?

[Leonard Paolillo:]

Yes, I think the question around the long-term share. What we're talking about here as a new-to-brand share among people that have prescribed TRUDHESA already. When you look within our super targets, which are the top 2000 of our targets, I think what we see through Q4 is achieving about a 3.5% share of that branded acute new-to-brand market. And that sets us up to that foundation in 2022. To touch on the second part of your question, which was what are some of the things that we look at to expand the size of the Salesforce? Well, it's twofold, obviously, you want to see in-market prescription progression, which we believe we will see. But also net price, we want to make sure that our payer contracts are pulled through so that as we expand our Salesforce and begin to generate more volume with that expansion, that that's profitable volume. Getting a little bit deeper, you want to look at your you're just getting market Salesforce activity metrics, as we see that we have the opportunity to go layer down in the deciles, that's when we would add additional Salesforce to tighten up the size of some of the territory so that we can increase some frequency. But really, it comes down to that prescription evolution, and then the securing of our net price.

[John Leaman:]

And to add, I think I would just add as well, that just to remind you of one of the slides we showed a number of months ago, in fact, indeed on our first earnings call, I think and that demonstrated that if you actually looked at prescriptions that have been written for Nurtec and Ubrelvy since long, it's roundabout 75% to 80% of prescriptions have come from around about five to 5,500 physicians with a strong focus on neurology. So I only emphasize that because this data shows that that targeted strategy that we've got in place is working in practice, we are focusing on those physicians that are well aware of and supportive of DAT and see the right place in physician’s armamentarium. So clearly, I think I've always mentioned that the first and second quarter of next year are very important from a strategic point of view we are very pleased to where we are and I'm looking forward to having that decision to make in relation to investing into this opportunity and growing the size of the salesforce and decisions on that will be dictated. But what we anticipate has been strong growth with the TRUDHESA as we move through next year.

[Eddie Hickman:]

Great. And then just really quickly on the 105 program, can you just talked just broadly if there any sort of additional risks with using sort of a powder formulation within the POD technology versus a liquid formulation and sort of how we should think about those decay comparison?

[Adrian Adams:]

John, do you want to just touch on that?

[John Leaman:]

Yes, Eddie, one of the things that the team beyond sort of the POD, is that they put the formulations together, obviously TRUDHESA is a liquid formulation because we used Migranal, which had been in the market for 30 years. But with INP105 program, that is a dry powder formulation that was specifically made for olanzapine. It's a device that was specifically made for the dry powder and it works very similarly to the liquid, which is one of the ideal pieces of the POD platform. And so we don't anticipate any additional sort of risks with the dry powder versus the liquid. That was one of the reasons why we did the Phase 1 to just look at the safety. And obviously Adrian's talk to the efficacy, which was better than intramuscular injection. So we're pretty bullish on the prospects for this, especially given how olanzapine works on aggression in multiple other sort of indications.

[Eddie Hickman:]

Thank you so much, and congrats again on the progress.

[John Leaman:]

Thank you very much.

[Operator:]

Your next question comes from the line of Laura Chico from Wedbush, your line is open.

[Laura Chico:]

Hey, good morning, guys. Thank you for taking the question. I just wanted to drill into the script metrics that you provided. So you're indicating a target of about three to 4,000 scripts here. Could you talk a little bit more about your assumptions to get to that level, and I'm assuming no further access wins are necessary to get to that that point, and then also on the 750 unique prescribers that would be about a roughly a doubling on the number of prescriptions per doc, if I'm doing the math right. So I guess I'm curious, how do you see that actually breaking out in terms of within the super target demographic versus broader neuro or PCP setting? Thanks. And I have one follow-up.

[Adrian Adams:]

Yes. Leon, maybe you can had some comments, and then I’ll comment.

[Leonard Paolillo:]

Sure. Thanks Laura. So if you look back at some of the slides, you can see the depth that starts to get driven, particularly by our super target. So the 750 number isn't just super targets, that's all targets, however, we do anticipate on the number of those will be super targets, and you start to see, for example, the average number of prescriptions for super targets, right now is 4.2. And you compare that to target it's a bit less, the same kind of metric follows with neurologists versus PCPs. So neurologists average about 2.1, whereas primary care physicians average about 1.5. So you start to get to the 750 number through AV expansion and the time it takes for our salesforce to gain access to the various targets that we have. But one of the great things that we're seeing, and you see that both in the metrics against Ubrelvy and Nurtec, but also just in the sheer number of prescriptions, each one of the super targets against prescribe as they get on board and begin to give it to their patients. So those are the two things that we're using to wind up at that three to 4,000 and just some momentum that we see building in the field.

[Laura Chico:]

Okay, thanks. And then maybe just one, I guess, obviously, it's early days here on the launch so far, but any anecdotal experience, you can share in terms of the garden variety patient trying TRUDHESA? And I think, Adrian to your point, you gave some commentary or taller around this being in the post-triptan market, but I'm also curious kind of, what about the physicians prescribing it? And it sounds like the majority are kind of tilted towards the super users that are familiar with DHE. But any others kind of branching out? I guess I'd be curious and kind of anecdotal feedback so far on prescriber patterns?

[Adrian Adams:]

Yes, I think very good question. I think one of the things that we are -- two other things we're tracking obviously is its position the feedback that they're getting from patients and clearly I think getting more and more information on how patients are finding the product. So I think you are correct. And clearly a lot of our efforts in rollouts have been with our super targets and physicians are well aware of the benefits of DHE they've just been frustrated, they've never been able to deliver it in that consistent and unpredictable way. Although this week we had an example of neurologists whose daughter actually was a key migraine sufferer. He prescribed the product for his daughter. This is just an anecdote, but this is where we are at this point in time. But based on the feedback from his daughter was caught using his words deliriously happy, he immediately wrote 14 prescriptions. So I think -- so the product clearly works. And we've seen a number of examples of that were patients are actually finding that the efficacy that they've wanted, on demand is there for the taking. So we've had a number of anecdotal stories like that. So again, we're going to be collecting these over the course of time, so that we can translate those into information to share in a more widely basis. But so far, so good. I think this product works. And clearly, we just wanted to get into patient’s hands. And it's then when they start through the efficacy. Leon, do you want to add anything more to that?

[Leonard Paolillo:]

No, I think that's it. I think, as Laura said, it is still early days in one of the things we're excited about is that as patients get experience and come back to the neurologist or their headache specialist, and share the success with TRUDHESA, we think that's just going to build on itself and provide that feedback loop, which is why we have that bridge program in place so that patients get that satisfaction from trying to drug and give the feedback right to the physician.

[Laura Chico:]

Great. And I'll try to sneak one last one in. I think there's some Phase 3 data coming up for in the autism space. I think that's arriving probably the first half of 2022. Any thoughts on potential recruit’s olanzapine efforts if at all? Thanks, guys.

[Adrian Adams:]

John, do you want to comment on that?

[John Leaman:]

Yes, Laura. I think it's a great question. I'm just going to go back to the fact that we know olanzapine works with aggressions right bipolar, schizophrenia and others. I think it's got a well-known track record of safety. And so we're focusing on those pieces as we head into this aggression in autism. And again, given the past track record and the fact that a typical antipsychotic orally are given to this population, we think this PRN usage of 105 is going to be very, very attractive in the marketplace.

[Laura Chico:]

Thanks very much.

[Operator:]

[,:]

[Adrian Adams:]

Thank you very much, operator and thank you all for joining us this morning. We look forward to updating you on our continued progress as we complete 2021 and move into what we believe will be an equally exciting 2022 as we continue to create value for patients, healthcare professionals, and each and every one of you and the shareholders we serve. Thank you so much.

[Operator:]

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