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spk00: Ladies and gentlemen, welcome to the InPol NeoPharma second quarter 2021 earnings and corporate update conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press the star line on your telephone. Please be advised that today's conference is being recorded, and if you require any further assistance, please press the star zero. Thank you. I would now like to hand the conference over to your speaker today, Impulse Chief Financial Officer, Mr. John Lehman. Thank you, sir. Please go ahead.
spk03: Thank you, Operator, and good morning, everyone. We are delighted that you could join us today for Impel Neurofarmers' first quarterly earnings conference call, during which we will review our second quarter 2021 financial results, as well as provide a general corporate update. Joining me from MPEL this morning is Adrian Adams, MPEL's Chairman of the Board and Chief Executive 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.mpelnp.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 our webcast page that says, click here to listen. If we could advance to slide two, I'd ask everyone to review the forward-looking statements. And I would 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 it over to Adrian.
spk04: Thank you, John. And good morning, everyone. We certainly appreciate the time you are giving us this morning. On this next slide, slide number three, you will find the agenda for this morning's call. I will begin with a brief overview of our business and the potential value-generating opportunities that lie ahead. Then we'll review in a little more detail the commercial opportunity and potential for Tradesa in the rapidly growing and dynamic acute treatment of migraine market, including an overview of our core prelaunch and launch activities and plans. Following that, I will provide a summary of the market opportunity and outline plans for another of our development assets, INP 105, before turning the call back over to John to review our second quarter financial results in more detail. I will then conclude with a summary of recent and upcoming milestones before opening the call up for your valued questions. Turning now to slide number four. On this slide, I would like to highlight several points which we believe illustrate an attractive investment opportunity within Pell NeuroPharma. Earlier this year, the FDA accepted for review our new drug application for IMP104, the acute treatment of migraine headaches with or without aura in adults, a large and growing market opportunity. IMP104 is dihydroargotamine mesylate, or DHE. delivered directly into the vascular-rich upper nasal space using Impel's unique and proprietary POD technology. If approved, IMP104 will be marketed under the trade name Trudessa in the United States. The FDA has set a PDUFA target date of September the 6th of 2021, which reflects a standard 10-month review timeframe and is just three weeks away. We are planning to launch Trudessa early in October with a highly targeted go-to-market strategy, which will fully leverage existing knowledge, experience, and indeed support in use with DHE among neurologists and headache specialists. I will review this in a little more detail shortly. In parallel, we're also advancing our second lead asset, IMP105, which is being targeted for the acute treatments of agitation and aggression in autism. another disease area with significant unmet need. IMP105 also utilizes the unique Impel pod technology targeting the upper nasal space. To further illustrate our focus pipeline progress, you will see on our next slide, slide number five, the clinical candidates that we are currently evaluating. We believe that the Impel pod technology has the potential to unlock the therapeutic viability of a previously untapped treatment pathway, the vascular-rich upper nasal space, for a variety of serious medical conditions. Although we are initially focused on CNS disease, our strategic intent is to evaluate its broad utility potential in other therapeutic areas, either through internal organic development or through value-added corporate development and licensing activities. Please note to refer to our next slide, slide number six. Over the past year, we have carried out a tremendous amount of both qualitative and quantitative market research, including in-depth discussions with key opinion leaders, broader healthcare providers, and the patient community, all with the aim of better understanding what physicians and patients are looking for in terms of an ideal acute migraine treatment. Patient-reported outcomes were a critical part of our pivotal STOP301 Phase 3 study design, and this study produced excellent results. We are pleased that these study results were just published in the August 7th edition of Headache, the official journal of the American Headache Society. This is perfect timing, given our planned October launch timeframe. We believe that these data reinforce the potential for Dredessa to be a differentiated, well-tolerated treatment that, subject to approval by the FDA, has the potential to deliver rapid and reliable symptom relief for patients with acute migraine. In fact, the exploratory data show improved and sustained patient-reported pain freedom and pain relief rates compared to existing standard of care. Turning now to slide number seven. I would like to illustrate the strong growth that is being seen in the acute migraine market. At the end of 2020, there were 27 million prescriptions written in this market, an impressive growth of 15% year over year. This robust growth has continued into 2021, and it's important to note that much of this growth is being driven by non-tryptan therapies, and in large part, by the neurologist and headache specialist communities. It is also worth noting that despite this strong growth and the shift away from triptans, there is still a lot of turnover in therapies as patients and physicians continue to search for more effective and better tolerated therapy. This is the opportunity for Tredesa. I'd now like to summarize our planned go-to-launch market strategy as shown on our next slide, slide number eight. We will adopt a disciplined commercialization approach, and with an initial sales force size of 60 experienced sales professionals, we will pursue a highly concentrated prescriber base of around 8,000 physicians that are responsible for approximately 35% of market prescriptions. These 8,000 physicians will comprise of 4,000 neurologists, and 4,000 high prescribing primary care physicians. Importantly, our target neurologists account for nearly 90 to 95% of all prescriptions that are written for acute migraine amongst the neurologist community. These target neurologists are important, not just because of their strong influence on growth, but also because of their historical and current experience and support of DAT, a product that is recognized as being the gold standard efficacy product for acute migraine treatment. As we make progress during our initial launch phase, we do plan to further invest into this opportunity by doubling the size of our sales force and increasing our reach to nearly 45% of the marketplace. You will see on our next slide, slide number nine, that our commercial strategy also includes promoting swift and accelerated pair adoption to early introduction of Impel and Trudessa to the top five payer organizations. This work has been ongoing as part of our pre-launch efforts and utilizes our experienced medical affairs and market access professionals. We recognize the importance of developing strong market access in the post-trips and failure space, and we've set a goal of approximately 70% of commercial lives covered by the middle of 2022. In summary, we are progressing well with our pre-launch efforts and are confident in our disciplined and targeted approach to building share in this large and rapidly growing market. As we move to our next slide, slide number 10, I would like to underscore the broad clinical possibilities that we see with our pod technology platform. On the cusp of the imminent FDA decision with Tradesa, We believe that the POD technology has the potential to deliver numerous additional therapeutics, of which the next in line is IMP-105. IMP-105 is comprised of a powder formulation of olanzapine, which is the most commonly used treatment for acute agitation and aggression. But its use is currently limited to intramuscular injections. We believe that IMP 105 has the potential to significantly reduce emergency room visits for patients with autism spectrum disorder. We've uncovered this as being a major unpept 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 deescalating agitation and aggression episodes in the autism patient population. As we illustrate on our next slide, slide number 11, by targeting the upper nasal space in the studies we've conducted, IMP 105 achieved rapid IV-like absorption, which may provide an effective, convenient, and noninvasive future alternative for treating acute agitation and aggression in the home, community, or hospital setting. These phase 1 study results of IMP105 in healthy adults were published in the Journal of Clinical Psychiatry last year. The findings demonstrated that IMP105 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, according to a 2005 expert consensus, is easy to administer, non-traumatically administered, provides rapid tranquilization without excessive sedation, has 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 IMP 105, and we are planning to initiate a phase two proof of concept study in the fourth quarter of this year. With that, I'll now turn the call over to John to review our financial results for the quarter. John?
spk03: Thank you, Adrian. On this next slide, slide number 12, you will see our financial results for the second quarter of 2021. Research and development expenses for the second quarter of 2021 were $6.1 million, which compares with $6.8 million for the second quarter of 2020. The decrease in R&D spending was due primarily to a decrease in clinical costs post the completion of the CADESA Phase III trial. General and administrative expenses for the second quarter of 2021 were $8.9 million, which compares with $6.1 million for the second quarter of 2020. The increase in G&A was due primarily to the ramp-up in expenses for the commercial and marketing activity preparations for the TRAGESA launch. Please now refer to slide 13. For the second quarter of 2021, MPEL reported a net loss of $15.5 million compared to a net loss of $13.1 million for the same period in 2020. The net loss per share was $1.10 for the second quarter of 2021 and $35.88 for the second quarter of 2020. As of June 30th, 2021, the company had cash and cash equivalents of $60.9 million. This cash balance, coupled with the debt financing we announced on July 2nd, provided the company with a cash runway through the end of 2022. I would now like to hand the call back to Adrian, who will summarize before opening the call for questions. Adrian.
spk04: Thank you, John. On our slide, final slide, slide number 14. I would like to conclude by highlighting our recently achieved and upcoming milestones. This is an exciting and potentially transformative time for IMBAL. We have made tremendous progress so far in 2021 and look forward, subject to FDA approval, to successfully launching Tradesa into the rapidly growing acute migraine market and to initiating a Phase II proof-of-concept study with IMP105. We would now like to open up the call for your value questions. Operator, can you please give the instructions?
spk00: Thank you, and ladies and gentlemen, if you have a question at this time, simply press the star, then the number one on your telephone keypad. One moment, please, for our first question. Our first question comes from the line of Kent Cash Retour, a common company. Your line is open.
spk01: Hey, good morning, guys. Thanks for the call. Just a couple questions. Adrian, wondering if you can give a little bit of nuance on the FDA interactions, if we're in labeling or any color you can provide there. That's my first question. Then second question, really it's been a fantastic launch for both NERTEC and Ubrelvi, really good success with managed care and what appears to be very solid net value pricing per prescription. I was wondering if you could talk about how you feel you'll be able to do. Is that setting a nice example or a nice platform in terms of both managed care and pricing as we think about Trudessa? And then lastly, I was wondering if you could comment on views of failure rates between triptans and CGRP just looks like a, a massive opportunity, a lot of churn still in prescriptions. And, and so I was hoping you could frame, uh, the failure rates. Thanks so much.
spk04: All right. Thank you. Uh, thank you, Ken, for the, uh, for the question. And, uh, uh, I'm sure it's, uh, uh, it's the question that's on, uh, on, on many minds in relation to how things are tracking with the, uh, uh, with the FDA. And, uh, Clearly, I can't comment on specifics with the FDA. I would say that since our file was accepted for review in January, we've had a number of information requests, as is normal course of business with the FDA. We've responded to all of those questions promptly and clearly. and we are looking forward to the Purdue for date in three weeks' time. In addition, during the call, I did make reference to our commercial preparations for the early October timeframe. We have started the discipline build-out of our commercial organization. We've hired a head of sales. We've hired regional managers, and during the course, August, we are recruiting our 60-person sales force. So as you well know with the FDA, you don't know right up until the end, but I would say all the questions that we've had, we've responded in a prompt and timely way. On the second point on NERTEC and UBrelvi, I think you are quite right. We've actually been pleased with the success that they've had in the The marketplace, as you were seeing from our presentation, clearly that success is manifest in terms of a very high proportion of the market growth that is being driven by non-tryptan therapies. And clearly, I think we're delighted with that growth. Just to pick up on one of your last questions, I think one of the things that we have noted within the the marketplace to your point is that there is a tremendous turnover in therapies. Our estimates are that there are in excess of 50% of patients who have put on these treatments that tend to either switch away from or drop off therapy. And what is clear from all of the work that we've done is that that turnover in the market is being driven by by a desire for enhanced efficacy and enhanced tolerability. And clearly, we feel that illustrates the potential for Tradesa, and given the profile that the product has manifest in the STOP 301 study. I'll ask John to comment in a moment. I think you also asked questions in relation to pricing, the managed care and market access environment and, uh, and clearly, um, you know, our view is that, uh, a successful product launch is dictated not just by what you do at launch, but what you do ahead of launch. We've been doing a tremendous amount of, uh, of information exchange with the, uh, uh, the top players in the market access space. Uh, we want to, uh, have a goal of, uh, uh, of around about 70% of commercial lines being covered by the middle of next year, which is, uh, roughly what was achieved by some of the newer GPANs in that time frame. We are looking forward actually to exceeding that. And clearly the value proposition that we've had amongst payers with all the interactions we've had to date are allowing us to crystallize our overall pricing strategy with the products and indeed a pricing strategy that will give us the flexibility from a discount perspective, to offer a compelling rebate strategy. But, John, maybe I'll ask you to comment on that a bit further.
spk03: Sure. And I think, as we've previously stated, as we've looked at the pricing on basically a four-pack of prescriptions for Trudessa, we've looked at a range of different pricing, that range being somewhere between $600 to, let's say, $850 for the four-pack. And I think As we've taken a look at the pricing, we believe that we'll probably be towards the upper end of that range as we look at pricing. And, you know, I would just add that, you know, one of our major focuses is getting access through the payers. And I think Adrian and the team that he's brought on, which he's done this several different times, I think are making great progress in that.
spk01: Great. Thanks so much. Real exciting times. I'll go back in the queue. Thank you very much, Ken, for your questions.
spk00: And your next question comes from the line of Eddie Hickman of Guggenheim Securities. Your line is open.
spk02: Hey, guys. Thanks for taking my question. So if you get the approval next month, can you talk about what kind of launch metrics you'll disclose on future earnings and what you consider the most important sort of launch factors early in the launch? And then given your targeted strategy, how quickly do you think you can start to make a dent in the CGRP RX numbers? Thanks. Thanks.
spk04: Yes, I think, Eddie, thank you very much for your questions. I think, you know, clearly, just to emphasize, I think we are adopting a very targeted, disciplined approach to the market. And just to reiterate, targeting those 8,000 kind of target positions made up of predominantly neurologists and headache specialists. I only repeat that point because... Clearly, we do believe that one key measure of our success, given the belief we have in this targeted approach, is the market share evolution and prescription evolution in that target audience. So the metrics that we're going to be following, in addition to the kind of top-line prescription growth from an NRX and TRX perspective, is indeed market share evolution in that target group. We believe passionately that given the strong support and experience by the neurologist community who are already very supportive of the utility of DHE and the treatment of acute migraine, that measuring the uptake and impact by them is very important. So, clearly, those are going to be very important metrics. And clearly, over quarter one, of launch in quarter two, quarter three, as we evolve into next year, we want to make sure that we have a very strong start to the prescription journey. That is one of the reasons, obviously, we are investing in pre-launch efforts with our market access team with the top payer population. So that's how we will be measuring success over the first number of quarters. And clearly, I think one of the questions that you've touched on as well is obviously it's a very competitive market, and we want to make sure that we have a strong uptake. And we're putting in place a lot of programs to ensure that patients can get access to to our treatment very quickly during that initial launch phase in the fourth quarter of this year and into the early part of next year. So we are putting in place a number of quick-start programs which will ensure that patients, while we're building up our market or footprint in the market access area, that patients can get rapid access to the treatment. But, John, do you want to add anything to those points?
spk03: I don't, Adrian. I think I would just reinforce that, you know, as Adrian laid out earlier, there's 4,000 neurologists and 4,000 headache specialists is our target market. That's where we're looking to drive scripts. And I think, you know, monitoring how we're doing in that space is really going to be key to the success as we, we launch the product.
spk04: Yeah. And Eddie, just one final point. So again, thank you for your questions is that, um, The reason that we believe it's really important to monitor success in this target group of neurologists and headache specialists in particular, I think, is that if you actually analyze, I made reference earlier that we've been very pleased with the success of NERTEC and UBrelvi to date, but despite that success, there's been a lot of turnover in the market. It is also worth noting that if one looks at all of the prescriptions that have been written since launch, For Neurotech and Ubrella, in excess of 80% to 85% of those prescriptions have come from around about 5,000 to 5,500 prescribing physicians, with a strong predominance amongst the neurologist community. That is the essence of our targeting strategy and how we intend to grow this product moving forward.
spk02: Great.
spk04: Thank you so much for that.
spk02: Can you also just talk a little bit about the pipeline opportunities, like a little bit more about what you're thinking about, what kinds of trials you'll need in the autism indication and sort of what metrics you're looking at there and then what that program can look like if you show proof of concept?
spk04: Yeah, I'll ask John to just comment on the top line of that. John?
spk03: Yeah. So, Eddie, I think we're looking at, you know, initial phase two proofs of concept trial. As we've indicated, we plan on doing that in the fourth quarter of this year. That would be patients, you know, typically patients who have aggression in, you know, ASD, they have a stimulus. And so, you know, in the right environment, we can test basically our product versus a placebo, and we can use basically bipolar schizophrenia scales to basically take a look at, you know, the improvement in aggression that happens with or without our product. I think that will be the first step. We plan on having results in the second, excuse me, the fourth quarter of 2022 with that. And then basically the plan would be post those results to move into basically the phase three program, you know, going forward. But we'll start with a proof of concept. I think as Adrian has pointed out, you know, atypical antipsychotics have always worked in ASD. We're giving a much more convenient and I would actually say, you know, not a shot, but the ability to utilize it, you know, through the nose. And I think caregivers and parents were really like that in this population. So next steps is, as we said, fourth quarter of this year, we'll initiate the trial and we'll have results in the second half of 2022. Thanks, guys.
spk02: Appreciate it. Thank you.
spk00: Your next question comes from the line of Lara Chico of Redbush Securities. Your line is open.
spk05: Hey, good morning, guys. Thanks for taking the question. I think some of my questions have already been answered, but I guess maybe one on drug-device combinations. These are inherently a tougher review process, but you have the advantage of DHE being a relatively known quantity here. So I guess in terms of the device review, I'm just wondering if you can offer any commentary around maybe what have been the primary points of concern from regulators towards the NDA submission. Thank you.
spk04: Thank you, Laura. And clearly that's a very important question. We've been asked that quite a number of times. And again, I think one of the reasons that we have a confidence in this area is that all the way through development with Tradesa, we've used the same product or the same device. And clearly we've been doing that in consultation and discussion with with the FDA. In addition, I think if one looks at the drug component, DHE, we are sourcing that drug from Mifam in Italy. They're an FDA-approved manufacturer. They've been manufacturing for well over 20, 25 years and have a good inspection history with the FDA. So all of those particular components, I think, that consistency through development and that professionalism, I think, is something which we believe significantly lowers the risk that has been seen with other drug-device combinations. And I guess I'll point out, I think, over the course of the last number of months as we've been answering questions from the FDA in relation to both from a clinical and a CMC drug device perspective. We've answered all of those questions promptly and clearly. And I would consider all our interactions so far as being normal course of business. So that's how I would respond to that, Laurie.
spk05: Thanks very much.
spk00: Thank you, and I'm showing no questions in the queue at this time. I'll hand the call back to Mr. Adian Adams for further remarks.
spk04: Okay, thank you very much, Ludi, and I would like to thank you all for joining us this morning, and we look forward to updating you on our continued progress and corporate milestones going forward. Thank you so much for your time this morning.
spk00: Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect. Have a good day.
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