Impel Pharmaceuticals Inc.
Q1 2022 Earnings Call Transcript

Published: 17 May 2022

[Presentation:]

[Operator:]

[:]

Good morning, ladies and gentlemen, and Welcome to Impel Pharmaceuticals’ First Quarter 2022 Earnings Corporate Update Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Instructions on how to participate will be given at that time. [Operator Instructions] As a reminder, today's conference call is being recorded. Now I would like to turn the call over to Impel’s Chief Financial and Business Officer, Mr. John Leaman. Please, go ahead.

[John Leaman:]

Thank you, Raine, and good morning, everyone. We are delighted that you could join us today for Impel Pharmaceuticals’ quarterly earnings conference call, during which we will review our first quarter 2022 commercial and financial results, as well as providing a general corporate update. Joining me from Impel this morning is Adrian Adams, Impel’s Chairman of the Board and Chief Executive Officer; and Len Paolillo, 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 at www.impelpharma.com. If you are listening to this call on your telephone, you may access a synchronized slide deck on our website, by choosing the link on our webcast page that says, Click here to listen. Moving to slide two, forward-looking statements. 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?

[Adrian Adams:]

Thank you, John, and good morning, everyone, and thank you all for joining us. I'm both pleased and indeed excited to update you on the commercial and corporate progress we have made since our fourth quarter and full year 2021 earnings call in March of this year. With that, please refer to our next slide, slide number three. As many of you know the migraine market is large and dynamic and continues to deliver robust growth year-to-date. Despite this, there remains clear unmet need for patients, migraine patients who need predictable, consistent and well tolerated pain relief. This remains the opportunity for Impel and more specifically with TRUDHESA. As you can see on this slide, the strong launch trajectory continued with sustained cumulative growth in total prescriptions that we've seen not only through quarter one, but also into the early part of quarter two. At the end of April, cumulative prescriptions reached 16,750. This is close to 4 times the exit point at the end of 2021. Additionally, our acute branded nTRx share among writers of TRUDHESA has doubled since the end of 2021 to approximately 5% at the end of April. This is just seven months into the launch of TRUDHESA. Turning now to slide number four. I wanted to take this opportunity to remind you of our focused and disciplined commercial and targeted strategy with TRUDHESA. You have heard me mention before that we are laser-focused on 8,000 target physicians, this group being made of around 5,500 neurologists and 2,500 high-prescribing primary care physicians. To further support this strategy, you can see on this slide that over 70% of all gepant prescriptions written since their respective launches have come from just 8,000 physicians. And importantly, as it relates to our targeted strategy, 70% of those physicians are neurologists and 22% are primary care physicians. Over 60-person sales force is exclusively focused on key neurologists and headache specialists. And as you can see, a large majority of our targets are within this high prescribing universe, a focused, disciplined approach that makes sense when you follow these data. Now, as you also know, a fundamental and critical success driver for all pharmaceutical products is broad and competitive managed care coverage. As you can see on our next slide, slide number 5, we have made excellent progress on the market access front. Based on the quality and timely work of our Market Access and Medical Science Liaison teams, both pre-launch and in the immediate post-mark periods, we were quickly able to secure contracts, covering approximately 80% of commercial lives. This platform, together with continued expansion of downstream coverage policies is allowing our innovative access program Trudhesa Direct to shift patients from the Bridge program we have had in place since launch to reimburse therapy. We are pleased to report that the percent of prescription shipments that have been reimbursed grew to 51% in the first quarter of 2022, which, as you know, has been historically volatile period for patient reimbursement. We anticipate seeing continued improvement in these metrics, particularly as we move through the late second and early third quarter of this year. Please now refer to our next slide, slide number 6. On this slide, you can see that the average number of prescriptions per week is showing steady and pleasing month-over-month evolution. You will note that April showed a temporary slowdown. However, TRUDHESA growth outpaced the overall migraine market and the acute gepants, which in April declined by 13% and 14%, respectively. Importantly, we are delighted to show that TRUDHESA prescription momentum has increased heading into May with prescriptions reaching over 1,100 in just the first week of May. Based on Internal Pharmacy data for this past week, we remain confident that this performance trajectory will continue based on the growth we are seeing in both, new and refill prescriptions. Turning now to our growing prescriber base which is illustrated in our next slide, slide number 7. We're not only pleased with our ability to add new prescribers, but also the consistent activation of our high-volume Super Targets and Targets. In just the first four months of 2022, we have nearly doubled our total prescribers and increased our Super Target and Target groups by 66% and 138%, respectively. As you can also observe in this chart, we're also seeing an increase in Non-Target prescribing, but this does not reflect the deviation from our targeted strategy. In fact, at least 40% of the Non-Target prescribers are in the same account, as a Target or Super Target physician. Our field team is highly experienced and understands the importance of working the entire office. The other important and the pleasing performance trend we are seeing is continued and growing depth of prescribing once an account is activated. This is clearly another indirect measure of the growing acceptance of TRUDHESA in key influencer physician’s migraine treatment armamentarium. Please now refer to our next slide, slide number 8. On this slide, we are showing important data on the refill rates for TRUDHESA, rates, which have remained consistently around the 65% mark. This high refill rate is an indirect reflection of patient satisfaction with TRUDHESA and is higher and more consistent than what you would see with other competitive products at this stage in the launch. The consistency of this data, while looking at patient surveys and our own efficacy data from our Phase 3 STOP 301 study gives us confidence that this will continue. This is very encouraging data, and I will reference the strong refill rates again towards the end of my remarks. Turning now to slide number 9. I would like to reemphasize some important market dynamics that we believe support our commercialization strategy with TRUDHESA and reinforce our optimism with the product. I have discussed in previous calls, the incredible churn over we see maintained in the gepant market. The data from Symphony continues to show that approximately 60% of patients initiated on gepants either drop off or switch away from these products at some point, in our opinion, to find better, more consistent and predictable efficacy. To put this Symphony data in perspective and using Ubrelvy as an example, of the approximately 210,000 patients put on the product in the January of 2021 to February of 2022 time period, around 130,000 or 62% of these patients either dropped off the product or switched to another product. This continued churn over represents a significant opportunity for TRUDHESA. This chart also shows that in addition to serving as the acute medication for patients on a preventative or as the next step after failure of triptan, 35% to 45% of Trudhesa patients had a gepant as their most recent therapy. We believe that we are capitalizing on the churn over we see in the market by serving as the efficacious product patients can trust when they need to get back to their daily lives. I would like to remind you again of the strong refill rate we are consistently seeing with TRUDHESA, I would emphasize that many of the patients that start on TRUDHESA stay on TRUDHESA. Turning now to final slide in this section, slide number 10. I would like to further illustrate our progress in establishing TRUDHESA as an important option to either replace or complement gepants. Over the past 4 weeks, TRUDHESA has captured 9% of the post triptan market amongst TRUDHESA prescribers. This has remained consistent even as we have continued to increase our overall prescriber base. In addition, when looking at the top 100 prescribers of TRUDHESA, those that have adopted earlier and had time to expand their prescribing, the share of the post triptan market increases to 15%, again, data that has remained consistent. This consistency reinforces that prescribers fit TRUDHESA into their treatment algorithm we capture, maintain and grow prescribing. With that, I'll now turn the call over to John to review our financial results for the first quarter of 2022. John?

[John Leaman:]

Thank you, Adrian. On our next slide, slide number 11, you will see our financial results for the first quarter of 2022. The net product revenue for the first quarter of 2022 was $1.8 million. Initial shipments of Trudhesa to specialty pharmacies began in September of 2021, ahead of the October commercial launch. Research and development expenses for the first quarter of 2022 were $3.7 million versus $4.3 million for the same period of 2021. The decrease was primarily due to a reduction in TRUDHESA clinical expenses as the Phase 3 study was closed. Selling, general and administrative expenses for the first quarter of 2022 were $19.8 million, which compares with $5.5 million for the same period of 2021. The increase in SG&A was due primarily to the ramp-up in spending to support the commercial and marketing activity for the TRUDHESA launch. Please now refer to our next slide, slide number 12. For the first quarter of 2022, Impel reported a net loss of $27 million or $1.17 per common share compared to a net loss of $11.4 million or $15.09 per common share for the same period of 2021. As of March 31, 2022, the company had cash and cash equivalents of $130 million, which the company believes will provide sufficient financial resources to fund operations into 2024. With that, I would now like to turn the call back over to Adrian to make some additional and closing remarks. Adrian?

[Adrian Adams:]

Thank you, John. Before closing, I do want to make a few remarks on the development status and timings with INP105. I would like to turn your attention to our next slide, slide number 13. Firstly, I would like to again, underscore the broad clinical possibilities that we see with our POD technology platform. We were clearly pleased with last year's first cycle approval of TRUDHESA. 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 Impel is INP105. INP105 is comprised of a targeted formulation of olanzapine, which is the most used treatment for acute agitation and aggression, but 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, an area of unmet need as there are at least 220,000 ER visits a year. The Phase I study results of INP105 in healthy adults shown on this slide, demonstrated that INP105 reached peak plasma levels approximately twice as fast as intramuscular olanzapine 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, has a swift onset of action with sufficient duration to prevent untimely recurrence and has minimal risk for serious adverse events and drug interactions. This is the goal with INP105, and following productive discussions with the FDA we’re planning to initiate the CALM 201 Phase 2 proof-of-concept study during the first quarter of this year. Please now refer to our final slide, slide number 14, for some brief concluding remarks. As we have covered on today's call, we are delighted with a large progress to date with TRUDHESA, solid prescription on market share penetration in our targeted physician universe supported by a strong and growing managed care position and excellent physician and patient receptivity. With the prescription growth that we are seeing, we remain confident of not only delivering a solid second quarter 2022 with TRUDHESA, but also delivering total prescriptions within the previously communicated guidance range of between 70,000 and 85,000 prescriptions for full year 2022. We're also pleased that following the recent financing agreement with Oaktree Capital, we have a good cash runway into 2024, enabling us to be laser-focused on commercial execution with TRUDHESA for leveraging the POD technology with INP105 and assessing business development and partnership opportunities going forward. With that, I would now like to open the call up for your valued questions. Operator, can you please give the instructions?

[Operator:]

[:]

Thank you. [Operator Instructions] Your first question comes from Ken Cacciatore from Cowen. Your line is open.

[Ken Cacciatore:]

Hey, congratulations team on all the really good progress and nice internal metrics. Just had a couple of questions. The first is around pricing. It looks like we secured actually fairly healthy pricing, which dovetails to your commentary around managed care. But I was wondering if you could speak to where we saw Nurtec and Ubrelvy peak out last year and hopefully where they peaked out this year. I think it was around $500 per Rx. I know you're not going to get specific. Can you still just talk about in reference to those products, how you feel about ultimate pricing around TRUDHESA? And then also, just wondering, Adrian, if you could give some perspectives on the Biohaven acquisition? We know the price was around $11.5 billion, it's 50% of the market. So, I guess that means the oral CGRPs were valued around $22 billion or $23 billion. Can you just talk, though, in general, about implications for an acquisition like this and your thoughts around it? Thanks so much.

[Adrian Adams:]

Okay. Well, I'll address that question straight away and then I'll ask Len to comment on the pricing aspect. Clearly, obviously, we did see the news on Biohaven's acquisition and clearly, I think that reflects some very strong and good execution with Vlad and his team. So, congratulations to that. And I think it also reflects, clearly, as you well know, I think the very large opportunity that exists within the migraine market. From my perspective, I think to your point, I think in the end, the most important thing that we can do as a company, particularly given the progress that we are seeing from a prescription point of view is execute with excellence from a commercial perspective. And I'm pleased that you see that we are indeed doing that. I recognize that in this market and particularly, a market that is growing with successful products, but that's going to be noted by a lot of different players along the line. And clearly, I think in this market where there are always lots of M&A and acquisition possibilities, that possibility remains for any company, including Impel. Our focus is making sure that we control our own destiny and control those things that we can control. And what we can control is seamless, flawless execution with TRUDHESA. If that is noted by others than what will be what will be. But right now, we're very focused on really getting TRUDHESA up to that peak sales potential that it has well in excess of $500 million a year, and we'll see what the rest -- how the rest unfolds. But thank you for the question on that. On the aspects of pricing, Len, maybe you can comment and then perhaps John might want to reinforce one or two points.

[Len Paolillo:]

Sure. Thanks Adrian. So, Ken, I think we're going to follow that Nurtec curve pretty closely. If you look at the first four to five quarters of their launch, having a blended GTN for this year, where we're keeping about 40% and then heading into 2023 with about a $510 per prescription price. So, we're heading in the right direction. As you mentioned, we're pleased to see the evolution of our net price throughout the first quarter and then we do expect that to continue.

[John Leaman:]

Ken, I just reinforce to your point on what the evolution of that price per prescription looks like by the end of the year, we should be at our target of $510 per prescription as our gross to net sort of move to where we want them to go end of 2022 and 2023 and beyond.

[Adrian Adams:]

Ken

[Ken Cacciatore:]

Thanks, so much.

[Adrian Adams:]

Does that answer your questions?

[Ken Cacciatore:]

No, that's great. Thank you, and keep up all the good progress. Thanks so much.

[Adrian Adams:]

Thank you very much.

[Operator:]

[:]

Thank you. [Operator Instructions] Your next question comes from Laura Chico from Wedbush. Your line is open.

[Laura Chico:]

Hey, good morning, guys. Thanks for taking the question. I've got two and apologies, if I missed this already, but with respect to the refill rate, Adrian, I believe you reemphasized you're exiting here at 65% right now, which seems pretty high. Wondering if you could comment a little bit upon your distribution network versus some of your competitors? I think there were definitely some headwinds on gross to net, but also curious on volume. And then also a comment in the script here, you made was -- migraine scripts overall were down in April. Just curious, if you had any commentary you could add in there around drivers for that? Thank you very much.

[Adrian Adams:]

All right. Thank you and a very good early morning to you Laura. On the refill rates, as you mentioned, I think we are very pleased with we've maintained a very consistent high refill rate. And clearly, I think in the end, that's a in our view, an indirect kind of manifestation of the efficacy profile of the product. And because the human aspect of this is the patients want efficacy and they want it on demand in a predictably consistent way. And clearly, TRUDHESA appears to be offering that to patients. I think you're quite right from a distribution perspective, I think we use a specialty distribution network with Phil and CarePoint. And clearly, a very important part of that is when patients get a prescription within a very short period of time within a day to two days, they get product being delivered directly to them. So clearly, that makes sure that they can remain not only on our therapy, but also get the refills that they need to give them the efficacy that they need. So this distribution network is working extremely well for us. We're delighted with it. But in particular, the driver of it is to get the product to patients as quickly as they need it. And I think all of those are different components are driving the refill rates. And in relation to the second question, Len, maybe you want to comment on that.

[Len Paolillo:]

Sure. I mean it's interesting, March was quite robust from a new patient flow perspective. And you just saw that soften a bit in April, and we saw it across branded generic products. So it was pretty widespread. And if you look back historically to even last year, you saw a very similar kind of dynamic. So I think the driver there is just simply the new patient flow that we saw this year and last year in April. The interesting thing where we are now, as you look at previous years, it's always kind of hard to determine what might have been COVID influenced and what wasn't. I think this year, it's pretty clear that it was not. But we are confident that, that was a seasonal and short-term thing, and we'll continue to see very healthy new patient flow and prescription flow throughout the rest of the year.

[Laura Chico:]

Thanks, Len. That's very helpful. And if I could just sneak in one more on 105. I know you're preparing to kick off the study there. But I believe longer term, you're looking at switching to the device. Just wondering if you could comment a little bit then on interpretation of these results, once we get these relative to how a new device might kind of change things? Thanks.

[Adrian Adams:]

Yeah. Thank you for that. And again, we're very pleased with the productive discussions we've been having with the FDA, as you well know, the scenario of significant unmet need. And clearly, we hold a lot of interest in assessing 105 moving forward. I think the device that, we're actually using with 105 is a small kind of portable device. And really, if one looks at the enhancements to that going forward, to develop the actual commercial device, the commercial device will be very, very similar to that device. We recognize that, it's very important as we show with the TRUDHESA of maintaining device to the key development phase of the product is very, very important. So what we'll see one or two tweaks, I'm sure, based on any inputs we get from the Phase 2 proof-of-concept study. But a lot of the kind of uniformity of device will remain the same.

[Laura Chico:]

Thanks.

[Operator:]

[:]

Thank you. Your next question comes from Eddie Hickman from Guggenheim.

[Eddie Hickman:]

Yeah. Good morning, guys. Thanks for the question and congrats on the launch so far. So I'm wondering if you could talk about what type of slope we should expect to see in growth over the next three quarters, to make you confident in that guidance of getting to 70,000 to 85,000. And then sort of what are the levers over the next seven months that may determine being at the lower versus higher end of that guidance range? And then as a follow-up just wondering, in terms of penetration of your current targets, how much of the growth that you're seeing is due to new penetration within new docs, or additional prescriptions written by current docs? You saw a nice increase in docs writing like up to 10 scripts, so just curious sort of how much of the growth between those two segments?

[Adrian Adams:]

Okay. Thank you very much. And as we mentioned during the call, Eddie I think best on the kind of very good momentum that we're seeing this year and in particular the strong early May performance. We're very confident in relation to the second quarter kind of evolution with prescription perspective. I've always mentioned that clearly, I think we recognize that based on a very strong first three months of launch at the latter end of 2021. I think the first and second quarter of this year will help to shape the overall curve for the year. And indeed, it is doing that and doing that to expectations. So we anticipate, and we remain confident and increasingly confident in relation to not only kind of meeting and finishing within that range of 70,000 to 85,000 for the year. But clearly, best to be at the higher end of that range with good strong execution. So I think – again, I think the trends that we are seeing a very robust, I think the market is going – is continuing to grow very strongly and we're delighted with the kind of general noise and a worst generation that is more on the – in the marketplace, because as we show with the data, I think the refill rates that we are seeing and the churn over in this market, a lot of the turnover is based on efficacy and the delivers efficacy in a consistent, predictable way is indeed TRUDHESA, all of those different dynamics and metrics really come into the equation in relation to our confidence in moving forward. As it relates to your question in relation to what might influence the kind of where we finish in that range. What I've always said is, that as we move to 2023, our plans or base plans, as you well know, I think to look at potentially doubling the size of our sales force to obviously, leverage the strong momentum that we are seeing within the market. And in the amount that we do see this momentum continuing, we will continue to assess whether or not we gradually increase and invest into the opportunity with increase in sales force towards that doubling in the 2023 time frame. And in keeping with investing into the market access footprint that we're seeing in the market. So, all of these are totally within our control. And clearly, I think it will be assessed in that on an onward basis. And then, maybe on the third part, maybe you want to talk about.

[A – John Leaman:]

Sure. So Eddie, I think the question was around the penetration of current targets and expansion of additional writers. I mean they're obviously both critical. And I think there's a really interesting data point that we're seeing emerge along with the very high refill rate among patients, we have a very similar kind of behavior among physicians, and we kind of refer to it as the stickiness of our prescribers. In fact, less than 3% of all of our prescribers are what we would consider to be lapsed, meaning they haven't started a second patient within eight weeks of starting their last. So every prescriber that we added in April, we added 150 new prescribers and 45 super targets. We have very high confidence that they're going to continue to drive depth. And so it is maybe not easy for me to say, it's going to be more important that we drive depth or breadth of prescribing because they do go hand in hand. As we add new prescribers, they continue to prescribe and drive that depth, as you note, in the chart. So we need to continue that momentum, but we feel very comfortable based on our field activity and the receptivity in the market that, that will continue.

[Eddie Hickman:]

Great. Thanks, John.

[A – John Leaman:]

Thank you very much.

[Operator:]

[:]

Thank you. And there is no further question at this time. You may continue.

[Adrian Adams:]

Thank you, Operator, and thank you all for joining us this morning. We are looking forward to updating you on our continued progress throughout this year, as we continue to create value for patients, health care professionals and indeed you, the shareholders that we serve. Thank you so much, and we'll talk to you on our next call. Thank you.

[Operator:]