Impel Pharmaceuticals Q3 2021 Earnings Call Transcript

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November 14, 2021

There are 7 speakers on the call.

Operator

Good morning, ladies and gentlemen, and welcome to Intel's NeuroPharma's Third Quarter 2021 Earnings and Corporate Update Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded. Now, I would like to turn the conference over to Impel's Chief Financial Officer, John Dieman.

Speaker 1

Thank you, Gail, and good morning, everyone. We are delighted that you could join us today for Impel NeuroPharma's quarterly earnings conference call, during which we will review our Q3 2021 financial results as well as provide a general corporate update. Joining me from Impel this morning is Adrian Adams, Impel's Chairman of the Board and Chief Executive Officer and Lynn Paoluo, our Chief Commercial Officer. Before we begin, I'd like to remind everyone that we have a slide presentation to accompany our conference call this morning, which can be viewed at our website atwww.impelmp.com. If you are listening to this call on your telephone, you may Access the synchronized slide deck on our website by choosing the link on the webcast page that says click here to listen.

Speaker 1

Moving to Slide 2. I would 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?

Speaker 2

Thank you, John, and good morning, everyone, and thank you for joining us. I'm both grateful and indeed excited to update you the progress we have made since our quarter 2 earnings call. As I am pleased to say, we have achieved a number of significant milestones over the past few months. On this next slide, Slide number 3, 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.

Speaker 2

Given that this is only our 2nd 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 will then turn the call over to John to review our Q3 financial results in detail. I will then close by briefly touching on the clinical development status of IMP-one hundred and five and summarizing our year to date progress against corporate goals we set at the beginning of this year before opening the call up to your value questions. Turning now to our next slide, Slide 4. For those on the line who may be new to Impelm, 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 for growth and success in the short, medium and long term.

Speaker 2

First, the recent FDA approval of our first product, Trudhesa, for the acute treatments of migraine headaches with or without aura in adults has opened up a large and growing market opportunity for Intel with significant revenue potential. The commercial launch of Tradessa in early October is focused around a highly targeted go to market strategy involving a 60 person sales force targeting 8,000 high prescribing physicians with a heavy emphasis on neurologists. The clinical development program for our new relief product candidate, IMP-one hundred and five, which is being evaluated via acute treatments of agitation and aggression in Artisan is also progressing. In fact, our Phase 2a proof of concept trial, known as the KALM-two zero one study, is planned to be initiated in the late quarter 4 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 its ability to deliver rapid and consistent relief of symptoms with injection like efficacy for doing this in a non invasive convenient way.

Speaker 2

Please now refer to our next slide, Slide number 5, where we will turn to the details of our targeted commercial launch activities and strategy with TRUDESSA. The commercial launch of Tradessa is indeed off to a fast start as we continue to execute well against our key commercial priorities. The Q3 was a busy one and we hired, trained and deployed our 16 neurologist sales specialists. The team is motivated by admission to help patients still searching for predictable and consistent efficacy despite the many new options. We have also put in place a performance aligned incentive scheme to reward them for strong sales achievement.

Speaker 2

Complementing our sales efforts, we have trained 75 key opinion leaders speakers to deliver peer to peer education events covering the Trogressor clinical data as well as its place in Clarape. Additionally, our targeted Digital direct to consumer activity has started and will increase its volume throughout quarter 4 and well into 2022. We're also pleased to learn market access progress. Indeed, payer discussions are progressing according to plan And the performance of our Trudhesa Direct Pharmacy Partnership and Bridge program is above expectations. Importantly, with low abandonment rates, which in turn signals high patient satisfaction.

Speaker 2

You'll see on our next slide, Slide number 6, that we have begun 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 27,000,000 prescriptions written in this market, an impressive growth of 15% year over year. This growth is being driven by the non triptan segments of the market and in large part by the neurologist community. Our commercial strategy is focused on a concentrated prescriber base, which allows for 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.

Speaker 2

Importantly, these target physicians prescribe 60% of Acute branded prescriptions and 65% of all DHE prescriptions. To provide an early perspective of how this smart targeted approach to commercialization is leading to prescription productivity, I would like to turn to our next slide, Slide 7. Symphony Health data as shown here provides a view of our 1st 4 weeks of launch. This shows strong week over week growth in both prescriptions and indeed prescribers. Our all internal pharmacy data shows approximately 250 prescribers as of October 31st, given an average of 2.5 TRUDESA prescriptions per prescriber.

Speaker 2

Not surprisingly and indeed pleasingly, 83% of our prescribers are targets of our sales efforts. With around 6 60 prescriptions in just the 1st 4 weeks of launch, Tradessa has clearly gained the attention of physicians and the Tradessa Direct Pharmacy Partnership has provided a streamlined experience to patients. On this next slide, Slide number 8, we are pleased with the growth in prescriptions in both our target prescribers And by how these prescribers are writing. Our launch efforts have a 2 pronged progress. The first is on generating immediate uptake in prescribing and the second is on creating depth and breadth of current prescribers.

Speaker 2

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 who are non targets. It is also encouraging to see we have a subset of prescribers But I've already written more than 6 or even 11 plus prescriptions. As you can see on this slide, it shows our efforts of making clinicians aware of TRODESSA is paying off. On our next slide, Slide number 9, It is clear that prescription share within our super targets provides quantitative signals that TRODESSA will hold a significant place in physicians treatment mounts in Ontario.

Speaker 2

We are using Symphony Day help Due 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 shows that TRULESA is already capturing 2.4% of the new to brand market After only 4 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 Goodeso prescription growth in the future. I would now like to turn to Slide number 10.

Speaker 2

On this slide, we are illustrating the utilization of TRODESSA among our early prescribers. It is exciting to see that around 14% of the new patient starts are already going to Tradessa. As this is only our 1st month of launch, This already shows competitive success and compares favorably to Nurtec and UBRELVI 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, TRUDESSA can fill that search for efficacy. This very much speaks to the evolving potential for Tradessa in this large market and importantly in the post triptan failure market.

Speaker 2

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 4 expectations with Trudhesa. As we have reviewed, although early in the launch, the 1st 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.

Speaker 2

Sales force execution has been both productive and successful as manifest in terms of strong weekly prescription trends and growth in terms of both the number and depth of prescribing with neurologists in particular. We anticipate based on this strong start that we will finish the year with around 7 50 unique prescribers and subscription base of between 3000 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 to Tradessa will put us in a strong position for 2022 and a 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 Q3.

Speaker 1

Thank you, Adrienne. On our next slide, Slide number 12, you will see our financial results for the Q3 of 2021. The net product revenue for the Q3 2021 was $100,000 Initial shipments of Tradessa to specialty pharmacies began in September of 2021 ahead of our October commercial launch. Research and development expenses for the Q3 of 2021 were $5,900,000 for Q3 2021 compared to 6 $100,000 for the same period in 2020. The decrease was primarily due to the decrease in Tradessa clinical expenses as the Phase 3 study was closed.

Speaker 1

Selling, general and administrative expenses for the Q3 of 2021 were $16,300,000 which compares with $2,900,000 for the Q3 of 2020. The increase in SG and A was primarily due to the ramp up in spending to support the commercial and marketing preparation for the Tradessa launch. For the Q3 of 2021, Emco reported a net loss of 25,000,000 were $1.24 per common share compared to a net loss of $9,200,000 or 15.56 $0.07 per common share for the same period in 2020. Please announce refer to the next slide, Slide number 13. As of September 30, 2021, the company had cash and cash equivalents of 111,300,000 In July, the company completed a $50,000,000 debt financing, dollars 30,000,000 funded during the Q3 of 2021 And repaid the Avenue term loan of $10,900,000 including prepayment fee.

Speaker 1

Further, we have $20,000,000 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 48,300,000 We believe we have sufficient financial resources given the debt and net equity financing to fund the operations into 2023. With that, I will now like to turn the call back over to Adrian to make some closing remarks. Adrian?

Speaker 2

Thank you, John. Before closing, I did want to make a few remarks on the development status with IMV105. I would like to turn your attention to this slide, Slide 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 TRODESSA and pursuant to this we believe that the POD technology has the potential to deliver numerous additional therapeutics of which the next in line for IMTEL is indeed IMP105.

Speaker 2

To remind everyone, IMP-one hundred and five is comprised of a powder formulation of Olanzapine, which is the most used treatment for acute agitation and aggression, for its use is currently limited to intramuscular injection. We believe that IMP-one hundred and five has the potential to significantly reduce emergency room visits for patients with autism spectrum disorder. We've 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 IMP105 in healthy adults shown on this slide were published in the Journal of Clinical Psychiatry last year.

Speaker 2

The findings demonstrated that IMP105 reached peak plasma levels approximately twice as fast as intramuscularalanzapine, currently marketed as Zyprexa and 10 times 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 IMP105. We are delighted to confirm that we are on schedule to reinitiate a Phase 2 proof of concept study towards the end of the Q4. Turning now to our final slide, Slide number 15.

Speaker 2

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 we articulated at the beginning of 2021. These milestones as you can see include the completion of the initial public offering and successful following our offerings as well as the FDA approval and commercial launch of our first product, TRUDESSA, transitioning Impelc into a commercial company. We are looking forward to initiating the Phase 2 proof of concept study with IMP105 in the 4th quarter and to completing what has been a transformational year for INPAL. With that, I'd now like to open the call up for your valued questions. Operator, can you please give the instructions?

Operator

Please standby while we compile the Q and A roster. Your first question comes from the line of Ken Cacciatore from Cowen. Your line is open.

Speaker 3

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. I wanted to drill down a little bit to talk about the net pricing that you're hoping for, how those initial discussions are going.

Speaker 3

We see Nurtec and UBRELVI 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, I think consensus shakes out in that range around $50,000,000 So wondering if you could just Speak to it with a little bit more specificity. That was question number 2.

Speaker 3

And I have a couple of follow ups, but I'll stop there and let you answer those. Thanks.

Speaker 2

Yes. Thank you very much, Ken. I think I'll ask Len to comment in a moment. But you're right, I think, as you may recall, I think During the kind of May, June 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 launch and into the Q4 with a strong building growth of commercial lives coverage.

Speaker 2

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 The actual contracts, I'm going to ask Len to comment on that. Len?

Speaker 4

Sure. Thanks, Adrian, and thanks, Ken. So they're progressing As we thought they would. I think one of the great things is when where the company sees Tradessa positioned, which is firmly after triptans And you think about where the plans want to put in some utilization management, we see good alignment there, right? It's 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 TRODESSA.

Speaker 4

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.

Speaker 2

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 analyst expectations. But John, maybe you can comment.

Speaker 1

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 analyst expectations for 2022, you know that there's sort of a broad range, right, 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.

Speaker 1

I think you're 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 how you've laid out 20222023 is in line with what we're hoping to do in the coming year.

Speaker 3

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 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.

Speaker 3

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.

Speaker 2

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 Clearly, we've seen the power in the marketplace on direct to consumer advertising, etcetera. We are delighted that that's been driving A tremendous amount of growth within the migraine market.

Speaker 2

I think as you also know, I think We've always stressed that being a very financially disciplined and importantly targeted approach to our commercialization. So we 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. We based on performance, we anticipate that 2022 is going to be a strong year based on that performance. There are 2 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 sales force as we move into 2020 All of this clearly is going to be dictated by what we anticipate as being a strong first half of next year.

Speaker 2

So Financial discipline, very targeted, looking in particular to build a very strong base of utility And endorsement by neurologists and then broaden that out and earning the right and the ability to be able to do more extensive promotion under consumer activity. John, maybe you can comment on the spend levels.

Speaker 1

And Ken, I think to your question, I think the Q3 is Probably a pretty good caveat as we move forward into the Q4 and then into 2022. I think obviously you were ramping up for basically the sales force and to get ready to go out and launch TRUDESSA. 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.

Speaker 3

Great.

Speaker 4

Thanks again.

Speaker 2

Thank you, Ken.

Operator

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

Speaker 5

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 the sort of current 4 weeks for Jurdesa, you're getting almost 14% of the new to brand starts. Given your sort of guidance for 2022 within the analyst range and 3,000 to 4000 scripts, like what percentage sort of target Does that indicate within sort of that new to brand starts within the competitors?

Speaker 5

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 sales force and sort of how much would that cost and when? Thanks.

Speaker 2

Yes. Again, I'll ask Pielen 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 TRUDESSER 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 TRUDESSA fitting in the Alimentarium physicians. And we always said that TRODESSA should be placed post triptan failure and competing directly with Eubelbry and Nurtec.

Speaker 2

And clearly, this early data gives us kind of optimism and indeed excitement around the kind of shares we're already generating. Now 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. And Len, do you want to add to that?

Speaker 4

Yes. I think the question around the long term share, what we're talking about here is a new to brand share among people that have prescribed TRODESSA already. When you look within our super targets, which are the top 2,000 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 sales force, well, it's twofold.

Speaker 4

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 sales force and begin to generate more volume With that expansion, that's profitable volume. Getting a little bit deeper, you want to look at your just in market sales force activity metrics As we see that we have the opportunity to go layer down in the decile, that's when we would add additional sales force to tighten up the size of some of the territory so that we could increase some frequency. But really, it comes down to that prescription evolution And then the securing of our net price.

Speaker 2

And to add, Alex, I would just add as well that I just remind you of 1 of the 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 Neurotech and UBRELVI since launch, Around about 75% to 80% of prescriptions have come from around about 5,000 to 5,500 physicians with a strong focus On neurologists. I only emphasize that because this data shows that that targeted strategy that we've got in place is working in practice. Since we are focusing on those positions that are well aware of and supportive of DAT and see the right place In physicians' augmentarium. So clearly, I think, always mentioned that the first and second quarter of next year, very important from a trajectory point of view.

Speaker 2

We are very pleased with where we are. And I'm looking forward to having that decision to make in relation to Gradually investing into this opportunity and growing the size of the sales force. And decisions on that will be dictated, But we anticipate as being strong growth with the TRULESA as we move through next year.

Speaker 5

Great. And then just really quickly on the 105 program. Can you

Speaker 1

just talk just broadly if

Speaker 5

there are 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 PK comparison?

Speaker 2

Yes. John, do you want to just touch on that?

Speaker 1

Yes. Eddie, One of the things that the team beyond sort of the pod, right, is that they put the formulations together. Obviously, Trudhesh is a liquid formulation because we used MIGRINOL, which should be on the market for 30 years. But with the IOP-one hundred and five program, that is a dry powder formulation that was specifically made for Olanzapine. It's in 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.

Speaker 1

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 has talked 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. Thank

Operator

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

Speaker 6

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 3000 to 4000 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 point.

Speaker 6

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.

Speaker 2

Yes. Len, maybe I can ask you to comment and then I'll answer that.

Speaker 4

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 targets. So the $750,000,000 number isn't just super targets. That's all targets.

Speaker 4

However, we do anticipate a number of those will be super targets. And you start to see, for example, the average number of subscriptions for super targets right now is 4.2. And you compare that to targets, 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.

Speaker 4

So you start to get to the 750 number through, a, the expansion And the time it takes for our sales force 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 UBRELVI and Nurtec, but also just in the sheer number of prescriptions each one of the targets begin to prescribe as they get onboard and begin to give it to their patients. So those are The two things that we're using to wind up at that 3000 to 4000 and just some momentum that we see building in the field.

Speaker 6

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 color 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 For 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.

Speaker 2

Yes. I think very good question. I think clearly one of the things that we are 2 of the things we're tracking obviously It's positioned feedback that they are getting from patients and clearly how things come getting more and more information on how patients are Finding the product. So I think you are correct. I think clearly a lot of our efforts in rollouts have been with our super targets and Physicians are well aware of the benefits of DHE.

Speaker 2

They've just been frustrated. They've never been able to deliver it in that consistent and In a predictable way. Although this week, we had an example of neurologists whose daughter actually was a key migraine So far, he prescribed the product for his daughter. This is just an anecdote, but this is where we are at Point in time, but best on the feedback from his daughter was of course using his words, deliriously happy. He immediately wrote 14 prescriptions.

Speaker 2

So I think so the product clearly works. We've seen a number of examples of that where Patients are actually finding that the efficacy that they wanted on demand is there for the taking. So we've had a number of anecdotal stories like So again, we're going to be collecting these over the course of time, so that we can translate those into information to share on a more widely basis. But so far so good. I think this product works and clearly we just wanted to get into patients' hands And it's them when they start to see the efficacy.

Speaker 2

Len, do you want to add anything more to that?

Speaker 4

No, I think that's it. I I think as Laura said, it is still early days. And 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 Which is why we have that bridge program in place so that patients get that satisfaction from trying the drug and give the feedback right to the physicians.

Speaker 6

Great. And I'll try to sneak one last one in. I think there's some Phase 3 data coming up for Rexiprazole, in the autism space, I think that's arriving probably the first half of twenty twenty two. Any thoughts on potential read through to your olanzapine efforts, Thanks, guys.

Speaker 2

Yes. John, do you want to comment on that?

Speaker 6

Yes, Laura, I think it's

Speaker 1

a great question. I'm just going to go back to the fact that We know Lonza Phe 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 Atypical antipsychotics orally are given to this population.

Speaker 1

We think this PRN usage of 105 It's going to be very, very attractive in the marketplace.

Speaker 6

Thanks very much.

Operator

We have no further questions at this time. I would now like to turn the call back to Adrian Adams for any closing remarks.

Speaker 2

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 moving to 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.

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