Good morning, ladies and gentlemen, and welcome to Impel Pharmaceuticals first quarter 2023 earnings and business update conference call. At this time, all participants are on a listen only mode. Later in this call, a question- and- answer session will be conducted, and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded. Now I'd like to turn the conference over to Impel's Chairman and Chief Executive Officer, Mr. Adrian Adams. Mr. Adams, please go ahead. Thank you operator, and good morning everyone. We are delighted that you could join us today for Impel Pharmaceuticals earnings conference call to review our first quarter 2023 commercial and financial results, as well as to provide a general business update in addition to highlighting the key priorities for Impel for the remainder of 2023. Joining from Impel this morning is Len Paolill o, our Chief Commercial Officer, Rajiv Amin, our Corporate Controller, and our new Chief Financial Officer, Michael Kalb. Michael brings to Impel an outstanding track record of executive leadership in finance, capital raising, business development, and operations management, and we are thrilled to have someone of his caliber and experience join our leadership team at this critical phase of our evolution. 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 on 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." 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. Now I would like to turn to slide number four, where I will summarize our first quarter and year-to-date performance with Trudhesa. Firstly, I would like to remind everyone of the tremendous opportunity that exists within this large migraine market. This is a market growing 10% year-over-year and becoming increasingly branded with most of that growth coming from newer non-triptan options. Within this market, we adopted a highly targeted commercialization strategy with a current sales force focus on 11,000 target positions made up of predominantly neurologists, headache specialists, and high prescribing primary care physicians. Together, this target group generates 73% of all branded prescriptions. Our journey with Trudhesa continues to make consistent progress, and we are pleased to announce first quarter 2023 revenue of $4.4 million driven by strong in-market demand of over 18,000 normalized prescriptions, over 70% of which were reimbursed. Importantly, our key leading indicator of new patient starts were up by 18% versus the fourth quarter of 2022. This momentum added to our stable prescription size of six pulse per prescription, a solid and high fill re-refill rate in the low 60% range, and an expanding prescriber base. These achievements to date form a solid foundation for continued growth as we move through 2023. With this said, let us now turn to slide number five to begin our commercial performance review with Trudhesa in more detail. As mentioned on the left-hand side of this slide, we are delighted to show continued robust growth in new patient starts, reaching over 3,600 in the first quarter, an 18% increase versus the fourth quarter of 2022. Now looking at the right-hand side of the slide, you'll note the momentum shifts at two distinct time periods. The first is late in the third quarter of 2022 as our field force expansion began to take hold. The second is the post-holiday period, or more specifically in March and April of 2023. It is this latest surge in new patients to provide us with additional confidence in Trudhesa's momentum as we move through the second quarter of this year. Turning now to our next slide number six. On the left-hand side of this slide, you will note the consistent quarter-over-quarter growth we saw throughout 2022. To date, we have generated just over 25,000 prescriptions, more than 100% increase versus the same time last year, and at a significantly higher net price. In the first quarter of 2023, we did see a small pullback in normalized TRxs. However, this was not surprising given normal first quarter dynamics seen with all products like deductible resets and reauthorizations. Moreover, we added to this unit pressure by proactively making targeted adjustments to our QuickStart free goods program. These adjustments, while producing a higher net price per prescription, did have an impact on volume. Please now refer to our next slide number seven. As mentioned in previous calls, given our targeted and disciplined approach to commercialization, we believe the most appropriate way of measuring our success over time is by market share evolution within our targeted group of physicians. Therefore, we are delighted to see continued market share evolution already reaching 4.7% share among prescribers of Trudhesa in the first quarter of 2023, just 18 months into the launch of Trudhesa. Driving depth of prescribing among our high-value prescribers, a larger proportion of whom are neurologists, is a critical success factor for continued growth in 2023. You'll note the significant share gains amongst our top prescribers, who now have Trudhesa accounting for 7.6% of their acute branded prescriptions. A clear sign that with continued investments and focus, we believe that Trudhesa can achieve the 12% share predicted by neurologists in independent surveys. Please refer to our next slide number eight. You'll remember that we secured key PBM and payer contracts quickly after launch in 2021, securing 80% of commercial lives under contract in just the first quarter of launch. This enabled consistent improvement in the percent of prescriptions reimbursed over the course of 2022, peaking at 60% in the fourth quarter. Now, in 2023, with established payer policies, we are taking steps to tighten the business rules associated with our free goods program and have seen the percent of prescriptions reimbursed jump from 60% in the fourth quarter of 2022 to 72% in the first quarter of 2023, with continued momentum and improvement to 75% in April. Importantly, our refill rates have remained consistent and solid in the low 60% range. This increasing reimbursement together with high refill rates provide a solid foundation for meaningful revenue growth in 2023. Turning now to slide nine. We continue to monitor the favorable market dynamics and source of business for Trudhesa. Symphony data continues to show that a very high percentage of patients, around 60% on gepants, specifically Nurtec and UBRELVY, drop off or switch away from these products at some point in therapy. Given the tolerability of these products, it is our contention that the primary reason for this continued turnover with gepants is that prescribers and indeed patients are not finding the rapid, sustained, and consistent efficacy they are looking for in their acute migraine treatments. This turnover in the market opens a large pool of eligible patients, and more specifically, a significant ongoing opportunity for Trudhesa. The source of current business for Trudhesa remains diverse, with approximately half of new Trudhesa patients switching from a triptan and a half from a gepant. We also note that Trudhesa is most often added to existing therapy as an efficacious, reliable, and non-oral option. Turning now to our final slide in this commercial section, slide number 10. It is against the backdrop of this growing branded market where so many patients still seek efficacy that we are launching our new targeted DTC campaign, Count On It. The campaign highlights the common challenge patients face when taking oral medications. Efficacy is often dependent on taking pills early. Unfortunately, life does not always allow that. We demonstrated in our phase III STOP 301 trial Trudhesa's ability to deliver efficacy even when taken late into an attack. For the past 18 months, we have heard patients relate the tremendous impact it has on their lives. We're excited to bring these authentic experiences directly to patients via key social media platforms and influencers, raising awareness of what good versus great looks like in the treatment of migraine. 2023 is off to a strong start, and I'd like to take this opportunity to thank all our talented, patient-focused, and dedicated team members across all the Impel functions for their continued professional and successful contributions. I'd now like to provide a brief overview of our financial results for the first quarter of 2023. Please refer to our next slide, slide number 11. The net product revenue for the first quarter of 2023 was $4.4 million, versus $1.8 million for the same period in 2022. This increase is due to higher Trudhesa sales volume and improvements in net price realization. Research and development expenses for the first quarter of 2023 were $3 million, versus $3.7 million for the same period of 2022. The decrease is primarily due to decreased personnel costs and program costs as we redirected our resources from R&D activities and pivoted our focus to supporting our commercial operations rather than research and development in the first quarter of 2023. Selling, general, and administrative expenses for the first quarter of 2023 were $22 million, which compares with $19.8 million for the same period of 2022. The increase in SG&A expenses during 2023 is primarily due to the ramp-up in spending to support Trudhesa commercialization activities. For the first quarter of 2023, Impel reported a net loss of $30.1 million or $1.27 per common share, compared to a net loss of $27 million or $1.17 per common share for the same period in 2022. Finally, as of March 31st, 2023, the company had cash and cash equivalents of $35.5 million. Related to this, we have ongoing discussions regarding additional capital and are optimistic of sharing progress in the near-term. With that, I would like to close with our final slide, slide number 12, which provides a summary of the Trudhesa performance in the first quarter and year-to-date 2023, in addition to outlining our ongoing priorities for the remainder of 2023. After a solid first full year of commercialization for Trudhesa in 2022, we remain pleased with the continued performance of Trudhesa in the first quarter of 2023, and in particular, with the strong growth in new patients and importantly, net price evolution. These lead indicator growth catalysts are providing excellent momentum as we journey through this, the second quarter of 2023. Regarding Impel's ongoing priorities in 2023, our execution focus remains on the following key buckets of potential value growth. Accelerating prescription and share gains with Trudhesa among our target physicians. Continued evolution of the Trudhesa net price and the result and positive impact on net revenue growth. Securing additional financing to fuel our ongoing commercialization activities. As previously mentioned, we do have ongoing discussions regarding additional capital and are optimistic of sharing progress in the near-term. Continued interest in aggressive and opportunistic business development. Finally, based on the performance and momentum to date, I would like to reaffirm our prescription guidance for Trudhesa for 2023. We continue to anticipate delivering prescriptions in the range of 80,000-110,000, the midpoint of which would represent a 64% growth over 2022. Thank you. We will now open the line up to your valued questions. Operator, can you please give the instructions? Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star one one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Stacy Ku with TD Cowen. Your line is open. Hi. Good morning. Thanks for taking our questions and welcome Michael to the team. Just a few. First, how should we think about the evolution of the net pricing this year? I know it's via the continued improvements of reimbursement, so just curious if we should still expect that $400-$500 net price per prescription by year-end. Second, nice to see that targeted DTC to keep Trudhesa top of mind. Can you also talk about a little bit more about the impact of the additional sales force? Have you gone through all the targets and how many times have you been able to kind of reach them as you think about just reminding clinicians to think about prescribing Trudhesa, just given all the benefits? Thank you. Well, thank you, Stacy. I'll reference the second point and ask Len to comment on your questions around net price evolution. I do recall when we first launched Trudhesa, we had a lot of questions around DTC and when we were going to take steps to invest in that. We are delighted on being able to roll out this DTC campaign. Clearly one of the aspects of that is to broadly raise awareness on the kind of patient experience that is happening with Trudhesa. More specifically, I think this is building on what we've already seen as being increased productivity with the sales force. As we articulated on our last call, I think the impact of increasing our sales force from 60 to 90 in the kind of July, August period of last year, we've seen significant kind of productivity and efficiency benefits of that, of that broadening of the sales force. Clearly some of the parameters and lead indicators that we've covered today, particularly amongst new patient starts and obviously prescription evolution are manifestations of that broad efficiency that we've seen. Clearly with our targeted strategy, initially it was 8,000 physicians. As I mentioned today, we've broadened that to 11,000 physicians. Not only are we continuing to increase the breadth and depth of prescribing within our existing super targets and targets within the target universe, but also I think the productivity increases that we are seeing in the additional target population are also starting to see significant benefits as we've rolled out over the course of time. Again, with a smart, targeted, disciplined approach to commercialization, it's all about execution focus, not losing sight of the base and foundation of our super targets, but building depth and broadening the kind of the utility prescriptions in our increased target physician population. We're very pleased with the evolution that we're seeing. In this marketplace, which is seeing significant growth, there is a lot more growth for us to build on as we are doing at this point in time. With that, Len, maybe you can just make some broad comments in relation to the changes we've made during the first quarter on QuickStart and the impact on net price evolution. Sure. Thanks, Adrian. Thanks for the question, Stacy. As you saw on the slides, we've been able to increase the percent of prescriptions approved from 60% at the end of Q4, now up to 75% in April, settling in at 72% in the first quarter. That's gonna lead to a very good evolution of the net price. We expect that percentage to continue to tick up over the course of 2023. In concert with that, as you know, in the first quarter, there's often the highest amount of pressure on your traditional copay, which is the buy-down from, you know, a $75 or a $50 copay, down to the $0 that we offer to reimburse patients. That pressure eases as you leave the first quarter and get away from deductibles and higher co-insurance and get into a more reasonable buy-down. That's gonna help also move our net price north as we move through the rest of the year. We still feel very confident about that $400-$500 range that you mentioned. Thank you. Thank you, Stacy. One moment for our next question. Our next question comes from Eddie Hickman with Guggenheim Securities. Your line is open. Hi, good morning, Adrian and Michael. Thanks for taking my questions. You talked about the post-holiday surge in scripts, the higher reimbursement you're seeing now in the second quarter and now this DTC campaign starting. I'm wondering how we should think about the script guidance you provided and if any of those metrics you think are gonna be most important in driving those revenues towards the higher end versus the lower end of that guidance. Thanks. Yeah. As we mentioned on the call, we are confident in reaffirming that guidance range and are tracking well towards that. We always knew that the momentum gained in the first and second quarter was gonna be really important. It's that momentum that has created the confidence that we have. Clearly, I think, there are many different lead indicators that are very important in terms of getting you on the right trajectory. Very importantly, I think, not only is building our prescriber base continues to be important, and that gets to the essence of our broadened target physician population, which is going very, very nicely in terms of consistent increases in new prescribers. Very importantly, the fuel of prescription growth is new patient starts. Seeing the very significant increases in new patient starts that we are seeing, that's gonna be the key driver, together with the consistently high refill rates that we are building up over the course of time. What I've learned in all the different products that I've launched over the course of time is that execution focus and disciplined execution is paramount. That's why we're focused on these key lead indicators. We are confident of that guidance range that we've given, and that confidence is based on not only first quarter, but very importantly, the momentum that we saw strongly in March and as we move through April and into May. That's what gives us the confidence. Len, I don't know whether you wanna add anything to that. No, I think you said it. I think the only additional comment I would make is about the expanding prescriber base, where, as we add prescribers, we notice they don't lapse. Meaning once they put a patient on, Trudhesa, it is very rare that they don't continue to prescribe. you know, the expanded sales force and the efforts we make in not only driving depth, but also gaining new prescribers, adds to that confidence because we know they'll continue to prescribe Trudhesa. Got it. You know, it seems to be like the tracking scripts is a pretty consistent, whereas the gross-to-net seems to be what is fluctuating, you know, in these first couple quarters of launch. I'm wondering, like, as that gross-to-net starts to stabilize, if you would consider like, providing revenue guidance at some point this year, or are you gonna stick with script guidance? Thanks. I think at this point in time, we're gonna be focused on prescription guidance. I think clearly, as we've moved through the fourth and into the first quarter of this year, we've made reference on this call to the proactive kind of evolution from our QuickStart program to drive additional kind of value, net price and, obviously net revenue growth over the course of this year. Clearly, I think given that we've gone through the transition quarter in the first quarter, which we're very pleased with the evolution that we've had. We do feel that at this point in time, we want to continue with prescription guidance. Clearly we'll continue to reassess that over the course of time. Thank you for the question on that. Thanks, Adrian. I'm actually, my apologies. I'm gonna just queue it for a question. One moment. Our next question comes from Sean Kim with JonesTrading. Your line is open. Yeah. Hi. Thank you for taking my questions. I guess I have a quick question on DTC. Just curious, how much of a step up do you expect from DTC campaign on your sales and marketing expenses? Going back to the net price evolution on GTN, if you net out the typical seasonality for the first quarter, just curious if you're seeing improvement in the underlying net price, you know, compared to the last year's, or if you're seeing kinda steady rate on net price. Thank you. Thank you, Sean. I'll take the first question. I think clearly, I think as we mentioned, I think we've when again, just stepping back to when we launched, I got a lot of questions over the timing of any DTC activity. We are very pleased that we've rolled out the Count on It program. Clearly, this is not a program which obviously utilizes television advertising. This very much is leveraging kind of the influences on the social media aspects, and very importantly, being able to get across the aspects of patient experiences as well. It's a very cost-effective discipline kind of approach to direct-to-consumer advertising. All of the statistics point to this being a very effective means of broadening the awareness and very importantly, broadening the awareness not only of physician kind of experience, but very importantly, the patient experiences as well. Again, we see this as being a very cost-effective way of not only supporting, but building on the overall prescription evolution with the product. Len, you may wanna add something to that, but also address the aspects of net price again. No, I think you addressed the DTC components accurately. On the net price evolution, you know, the one lever that we continue to talk about is the QuickStart of the free goods lever. As you can see, we're making consistent progress with that as we've made our adjustments in the first quarter. The other levers of our GTN are quite consistent and stable. As we continue to make the improvements on the QuickStart, as we continue to see the easing of the traditional co-pay burden and the gross-to-net, we expect to see consistent progress throughout 2023. I do think that we'll see an evolution over 2022 for sure. Thank you. I'm not showing any further questions at this time. I'd like to turn the call back over to Adrian Adams for any closing remarks. Thank you operator, and thank you all for joining us this morning. We do look forward to updating you on our continued progress during our second quarter call and later this year as we strive to continue to create value for patients, healthcare professionals, and obviously the shareholders we serve. Thank you very much and have a good rest of the day and indeed a nice weekend. Thank you. Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
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