Ladies and gentlemen, thank you for standing by, and welcome to the Impel Pharmaceuticals TRUDHESA Approval conference call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star then zero. I would now like to hand the conference over to your speaker today, Impel's Chief Financial Officer, John Leaman. Thank you. Please go ahead, sir. Thank you, Sarah, and good morning, everyone. Thank you for joining today's call. Last Friday, September 3rd, Impel issued a press release announcing the U.S. Food and Drug Administration's approval of Trudhesa. This press release is available on the company's website at www.impelnp.com, where you will also be able to access a recording of today's call. Before we begin, we would like to note that management's comments today may include forward-looking statements regarding the company's plans and expectations that are subject to risks and uncertainties that may cause actual results to differ materially due to various important factors, including those described in the risk factors section of the company's most recent Form 10-K and subsequent SEC filings. These filings can be accessed from the media and investor section of the company's websites or on the SEC's website. Any forward-looking statements represent management's view as of today, September 7th, 2021, and should not be relied upon as representing their views as of any subsequent dates. The company undertakes no obligation to update these statements publicly. Now, it is my pleasure to turn the call over to Impel's Chairman of the Board and Chief Executive Officer, Adrian Adams. Adrian? Thank you, John. Good morning, everyone, and thank you for participating in today's business update call. Joining John and I on today's call is Dr. Steve Shrewsbury, our Chief Medical Officer, and Len Paolillo, our Chief Commercial Officer, and they will also be available during the question and answer portion of this call. I would like to begin my comments by reiterating how pleased and excited we are to have announced last Friday that the U.S. FDA has approved Impel's new drug application for INP-104, which will be marketed as Trudhesa, the acute treatment of migraine with or without aura in adults. With this approval, we are delighted to now be able to offer the millions of Americans with migraine a non-oral acute treatment option that may provide rapid, sustained, and consistent symptom relief without injection or infusion, even when taken late into a migraine attack. For Impel, the approval of TRUDHESA marks the culmination of more than one decade of advanced engineering, research, and clinical development with the goal of pairing the proven efficacy of dihydroergotamine mesylate, or DHE, with our innovative POD technology. Before we go into a little detail regarding our upcoming launch plans and the commercial opportunity we see for Trudhesa, I'd like to take a moment to thank all the patients and investigators who participated in our clinical trials, as well as our dedicated employees and partners who are all instrumental in bringing this critically needed advancement to the migraine community. Our new drug application for Trudhesa includes the results of the phase III open label pivotal stage D study, STOP-301, which is the largest longitudinal study ever conducted with DHE using nasal spray delivery. In fact, more than 5,650 migraine attacks were treated over 24 or 52 weeks during the STOP-301 study. The study met its primary objective of safety and tolerability, and our exploratory efficacy findings showed it provided rapid, sustained, and consistent relief. Unlike some oral acute treatments that need to be taken within one hour of attack onset to be most effective, STOP-301 reported Trudhesa offered consistent efficacy even when taken late into a migraine attack. The overall clinical profile of Trudhesa emanating out of the STOP-301 study fits nicely compared with what healthcare providers identified in our pre-launch market research as being an ideal acute migraine treatment option. With this in mind, we are pleased with the label that has been approved by the FDA for TRUDHESA. We believe we have the promotional flexibility to position Trudhesa for potential utility in multiple patient types in the post-triptan failure landscape. As mentioned on our recent second quarter earnings call, we have completed all our pre-launch planning activities, and now that we are approved by the FDA, we are ready to launch Trudhesa in early October. On the organizational readiness front, we have completed the recruitment of an experienced and motivated specialty sales force, many of them being multiple sales award winners with previous neurology companies. Our launch meeting is scheduled for the end of September. From a market readiness point of view, we have completed critical exchange presentations and meetings with over 15 key pharmacy benefit managers or PBMs and health plans representing over 75% of commercial lives, and we have established a detailed market mapping exercise across the U.S. We've identified influencing networks amongst physicians and indeed patient groups. Integral to this has been the work of our experienced medical affairs group, a group that have already completed over 350 quality key opinion leader engagements with many more scheduled. On all commercial fronts, therefore, we are ready to execute a laser-focused, highly targeted go-to-market strategy, a strategy which will fully leverage and build on the existing knowledge, experience, and indeed support amongst high decile neurologists, headache specialists, and primary care physicians of the use of DHE for the acute treatment of migraine. In terms of the market opportunity, at the end of 2020, there were 27 million prescriptions written in the market, an impressive growth of 15% year-over-year. This robust growth has continued into 2021, and it is important to note that much of this growth is being driven by non-triptan therapies and in large part by the neurologists and headache specialists I have just referred to. Again, I would like to point out that despite this strong market growth and the shift away from triptans, there is still a lot of churn over in therapies, including the newer gepants, as patients and physicians continue to search for more effective therapies that are also better tolerated. We also know that prescribers are eager to have an option that circumvents the GI tract issues, which might help overcome common GI issues associated with migraines, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments. This is the growth opportunity we have with Trudhesa. As mentioned, we will maximize on this opportunity through a disciplined approach that includes an initial sales force size of 60 sales professionals, a sales force that will pursue a highly concentrated prescriber base of around 8,000 physicians who are responsible for approximately 35% of market prescriptions. These 8,000 physicians will comprise of 5,600 neurologists and 2,400 high-prescribing primary care physicians. Importantly, our target neurologists account for approximately 90% of all prescriptions that are written for acute migraine in 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 DHE, a molecule that is recognized as being a gold standard efficacy product for acute migraine treatment in the hospital setting. Now approved Trudhesa has the potential to provide that same gold standard DHE efficacy in a more predictable and consistent way to patients on demand at home. As we make progress through 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. We've previously highlighted that our commercial strategy includes promoting swift and accelerated payer adoption through early introduction of Impel and Trudhesa to the top payer organizations. We recognize the importance of developing strong market access in this post triptan failure space. We have already made excellent progress and have set a goal of having a minimum of 75% of commercial lives covered for Trudhesa by the middle of next year. I would also like to take this opportunity to announce that after careful consideration and modeling, we have decided on a U.S. list price of Trudhesa of $850 per prescription, with each prescription including four doses. We believe this price of Trudhesa reflects the value it brings to patients, including the demonstrated reduction of urgent care, hospitalizations, and emergency room visits by patients taking Trudhesa in our phase III study and the sustained pain relief. For example, a lower rate of need for rescue medication, also shown in our phase III study. One last commercial point I would like to make is that in an effort to help ensure appropriate patients have access, Trudhesa will be available through Trudhesa Direct, a hassle-free pharmacy partnership and co-pay program. Our digital pharmacy fulfillment partners, PHIL Inc. and CarePoint Pharmacy, will provide electronic prescribing and automatic enrollment in the patient savings program for eligible commercially insured patients without the need for a paper co-pay card. Importantly, our pharmacy partners will also provide a customized and seamless patient experience. Once the pharmacy receives the e-prescription, patients will be notified by digital communications that their prescription has been processed, and they will receive their medication by a convenient free home delivery. In summary, we are delighted with FDA's approval of Trudhesa and are ready to launch the product into the large and rapidly growing acute migraine market in early October. With that, I would now like to open the call up for your questions. Operator, can you please give the instructions? As a reminder, to ask a question, you will need to press star then one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Ken Cacciatore with Cowen and Company. Your line is now open. Thanks so much. Congratulations to the whole team, especially John. A lot of work, I know many years that you put into it, congratulations. Just was wondering, we've seen a lot of success from UBRELVY and Nurtec in terms of the pricing per prescription. Can you just talk about is that a good corollary we should be thinking about as you enter this launch? Is that the type of value you think you'll eventually be able to achieve? Wondering on Trudhesa Direct, can you just talk about your interaction ability to audit the program to be able to make sure that it's operating as you'd like? You just talked about your ability to interact with them and make sure that the metrics are hitting what you would like to see. Thank you so much. Thanks, Ken, for the questions. I'll ask Len in a moment to address the Trudhesa Direct point. Thank you for raising the price levels of Nurtec and UBRELVY. Clearly, I think there are many perceptions clear that both those products have done extremely well in this rapidly growing marketplace, and we are delighted that has been the case. That said, I think, as I referenced in the call, I think there has and continues to be a tremendous turnover in this marketplace. Around about 50% of those patients who go on those treatments who step off therapy. From a pricing perspective, I think we've been very conscious, particularly given the strong exploratory efficacy profile and safety profile of the product, to make sure that we position things in a very competitive way opposite the pricing of both UBRELVY and Nurtec. We do believe that has been the case. In addition, I think if one compares the price of Trudhesa that we're putting in place, $850 per prescription, and as a reminder, that contains four doses. That is a significant discount compared to other treatments that are delivered via the nasal space. Again, we do feel that we have a very nice pricing position opposite the competition, very competitive. Clearly, I think with this price level, just to put it into some degree of perspective, in any one year, there are around about 2 million patients that fail triptans. That's the space we, and indeed the gepants will be operating within. At that particular level, if we just capture 5% of that market, just 5%, we're talking about peak sales potential well in excess of a half billion dollars. The answer to your question on pricing is that we do feel that we are very competitive, particularly when one bears in mind the overall profile and the health economic benefits that came out of our STOP-301 program. On your second point, Len, maybe you can pick up on that. Sure. Thanks, Adrian. Ken, I think this is one of the advantages of this model is the visibility that we do have into the data from CarePoint and PHIL. We get daily and even real-time data feeds from them at both a field level but also an internal home office level at Impel. We can track things like PA success rates at a plan level. We can look at the time for PA completion. We could also monitor co-pay and our bridge program and the utilization of that program in real time. I think importantly, it also gives us visibility at every step along that patient journey to ensure they're having an optimal experience. If we do see any hiccups along the way, we could pinpoint our intervention and adapt accordingly. I think it's a great question, but it is one of the advantages of this model that we do have that amount of visibility. Just wondering, the level of interaction that you need from a clinician and sales force level. Are the clinicians or their offices going to be easily educated? Is this a program that's already in place and they know you all are now on it, be able to access it? Just the level of oil you need to put into the system to get this up and running. Then lastly, maybe wondering if you all would want to give a thought about 12 months of market share that you may be exiting at 12 months, if you want to give us any kind of sense of a guidance target or metric that you all are looking for after a 12-month window in terms of utilization share. Thanks so much. Len, maybe you can just touch on his additional questions on Trudhesa Direct, and then I'll touch on the guidance aspects. Sure. We hear from the market that they are quite used to this kind of digital pharmacy or specialty pharmacy prescribing. I think we've gone to great lengths to ensure that this is something that fits into the physician workflow. In terms of education, you're educating them. It's within their e-prescribing system already. We'd be able to provide to them the CarePoint and PHIL Inc. locations to prescribe to. It stays seamless within their workflow. Certainly, there'll be interactions with the staff in the HCP offices to ensure that they can work seamlessly with CarePoint and PHIL Inc., but we don't anticipate that being a very heavy lift. On the patient side, I think this also fits into how they want to be communicated with from a text message perspective. We have created plenty of access education materials for both physicians and patients to help them along this journey to get Trudhesa. Thanks, Len. On your point on guidance, at this particular point in time, we anticipate giving more formal guidance the early part of next year, which isn't that far away. What I would say is that a critical part to this, clearly, we are very confident on our fast start programs that Len has just gone through, and indeed, the kind of evolution well into 2022. One thing that I would reiterate at this particular point in time, it's driven a lot of our kind of strategy from a targeting perspective. We've recognized that. Again, I would emphasize that we are pleased that UBRELVY and Nurtec are seen as being successful products. That said, if one looks at all the prescriptions that have been written for those products since launch. Around 80%-85% of the prescriptions have been written by around 5,000-5,500 target physicians, all of whom are in our target group. As it relates to evolution of Trudhesa, we do believe that the market share evolution is going to be very much in keeping with the evolution of those products. Just to reiterate, I think the fast-track programs that Len has put in place, we believe is going to allow us to enter with a good managed care position at the end of this year, enter 2022 in a very competitive way. At that particular point in time, based on that evolution, we'll be giving more granular guidance in an overall prescription point of view. Again, I think one of the other points that we think is very important, our key measure of success, in addition to overall market share, is going to be share of our target audience and the evolution amongst neurologists and headache specialists. Clearly, we believe we're going to be successful in this targeted approach. Ken, thanks for your questions. Thank you. Thanks so much. Thank you. Our next question comes from the line of Eddie Hickman with Guggenheim. Your line is now open. Thanks for the question and congrats on the approval. Just two from me. Can you discuss any data you have that Trudhesa will work in patients who have failed, who specifically failed multiple triptans? Also if you have any data on whether you think it'll work in patients who have failed in the gepant class. In terms of the payer dynamics, given that it's fewer doses per script than the oral gepants, will patients have any trouble getting reimbursement for additional doses beyond the four every one or two months, given that the average number of migraines in some of these patients is over four per month? Can you just talk about that dynamic a little bit? Thanks. Thank you, Eddie, for those questions. I'll ask Stephen in a moment to comment on the aspects of efficacy parameters. Clearly from an overall payer perspective, we do take note of the fact, and I think you were touching on this, that unlike some of the gepant products, about 40% of the patients require that second dose. I think the vast proportion of patients who will be taking Trudhesa will be taking one dose, will get the kind of efficacy required with one dose. We do not anticipate that, given the kind of prescription totality for Trudhesa, we do not anticipate there are going to be issues as it relate to the pharmacy benefit managers or market access. Len, do you want to add to any of that before I hand over to Stephen? Sure. I think the point that you made regarding the need for a rescue dose of Trudhesa and how rare that is an important one in our discussion with payers. Additionally, given that we're in an early state of negotiations having just received coverage, I think the topic of quantity limit is certainly one that we'll be addressing. We haven't quite nailed that down with payers yet. Thank you. Steve, on the questions of where we stand in relation to efficacy with gepants, et cetera, and particularly those patients who are not adequate controlled on gepants. Maybe you can touch on those two points? Thank you, Adrian. Yes. A couple of points. Firstly, we did notice that very few patients required a rescue with Trudhesa. About 15% over the study, in fact, required a rescue dose. In terms of the baseline triptan use, there were certainly some patients who at baseline were taking triptan as their usual acute treatment. We haven't looked at those as a specific subset yet. It is one of our plans to do so over the next few weeks. We have no reason at this stage to believe that they don't respond extremely well as the other patients to Trudhesa. The gepants were not actually available at the time that the STOP-301 study started. They had not been approved. We did not have any patients who were taking gepants at baseline when they went into the study. However, we do have a number of abstracts and papers looking at CGRPs as a receptor class compared to the broad range of receptors that are covered by Trudhesa. We feel pretty confident that those that have failed a gepant will actually respond to Trudhesa. Second question was about the additional doses, more than four per month. In the STOP-301 trial, we actually allowed up to 12 doses per month with a maximum of two doses in any 24 hours and three doses in any seven-day period. The numbers that actually required higher numbers, higher than four per month, were actually very small in the study, and we haven't looked at those specifically. What we did notice was an overall reduction in the mean number of migraines per month that was pretty significant, about nearly a 50% drop in the average number of migraines per month by all patients in the STOP-301 trial. Thanks. Just 1 final one. How should we think about gross to net initially and then in the long term, and how should that compare to the gepant class? John, do you want to take that? Absolutely, Eddie. Good morning. I think like Nurtec ODT and UBRELVY, as we start out, we will have a bridging program that will allow patients who get a script to basically get their medicine prior to basically payer coverage. Right. Adrian and team have done this for a number of years. The trick there is obviously then to pull back that once the insurers start taking over for paying. As we think about where our gross to net ideally will be targeted as this bridge gets phased out over this year as basically payers pick up coverage, we believe we'll end up in the 60s for gross to net and feel pretty good about that. How that compares to the gepants, I think you'll have to look at their bottom lines. I think we have a very efficient commercialization strategy here, as Adrian said. We're targeting directly those neurologists who know and understand DHE. They use it in the ER, and they're looking for that kind of basically efficacy at home. We feel like we've got almost an unfair advantage within that group of physicians because they've used DHE for a number of years, and we're providing basically a therapy that's going to allow them to do that at home. That's basically the way we think about it, Eddie. All right. Thank you, guys. Yep. Thank you. Our last question comes from the line of Laura Chico with Wedbush Securities. Your line is now open. Thanks very much, and congratulations on the approval. I guess I wanted to follow up on one question related to the dosing frequency, and I just wanted to see if you could maybe elaborate a little on STOP-301 data. Could you remind us on the frequency that subjects actually used Trudhesa in that study on a monthly basis? Is that a good practice for us to apply here? Steve, do you want to just address that, please? Sure. As I mentioned, we actually provided up to 12 doses per month of Trudhesa throughout the STOP-301 trial for those patients in both the 24-week and the 52-week treatment periods. We did miss, as I mentioned, a reduction in the mean frequency from 4.7 to 2.4 migraines per month. There were very few patients, in fact, who were having the upper numbers, more than sort of eight or nine doses per month. We haven't specifically looked at those that did take the higher numbers. As I say, the numbers are actually pretty small. We plan to do so, and we will provide that data at a future conference. Maybe following up too on one commercial question. Among those initial physicians you'll be targeting in this first wave, could you talk a little bit about their familiarity and current use level with respect to Migranal or DHE at present? Yeah, I'll ask Len to comment in a moment. A very important part of the development of our kind of core target list, it includes, obviously, those very high-prescribing neurologists and headache specialists who are very familiar with DHE. There's also a subgroup within our target group that are what we refer to as DHE loyalists. They believe passionately in the kind of broader efficacy profile and tolerability profile of the product. Clearly, I think our overall target strategy is to get to the very essence of what you've touched on there, Laura, in terms of leveraging and maximizing the already existing knowledge of DHE in the marketplace. Len, maybe you can expand on that. Thanks, Adrian. Within our 8,000 targets, they represent approximately 65% of all of the DHE prescribed in the market, and we've obviously identified those physicians that prescribe the Migranal product consistently. I'd also point to the opportunity that Trudhesa has in that when we talk to those physicians through market research or advisory boards, you often hear that the reason they don't prescribe more DHE is the dissatisfaction with the current delivery system and the access issues that they have in getting Migranal through the payer access system. I think we have, as we've outlined, the POD device, which we think has the potential to deliver that in a more predictable and consistent way, and then also an access plan to enable the prescribing of Trudhesa to the patients that physicians have wanted to and continue to want to give DHE to treat their migraines. Okay, that's helpful. Maybe just one last question. With Trudhesa Direct going in play here, just wanted to confirm, would Trudhesa scripts still be visible in prescription tracking? Thanks. Len, do you want to address that? Sure. Yes, they will be visible in prescription tracking. Thanks very much. Thank you, Laura. Thank you. This concludes today's question and answer session. I would now turn the call back over to Adrian Adams for closing remarks. Thank you, and I would like to thank all of you for joining us this morning, and we are certainly looking forward to updating you on launch progress and corporate milestones during our third quarter earnings call in November. We certainly have been waiting for this day. We are ready to launch and believe passionately in our successful strategy going forward. Have a great day, and we'll talk to you later. Thank you. Bye. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.