Impel Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to Impel Pharmaceutical's second quarter 2022 earnings and business update conference call. At this time, all participants are in a listen-only mode. Later on 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 is being recorded. Now I'd like to turn the conference over to Impel's Chief Financial and Business Officer, Dr. John Lehman. You may begin.

Thank you, Kevin, and good morning, everyone. We are delighted that you could join us today for MPel Pharmaceuticals Quarterly Earnings Conference Call to review our second quarter 2022 commercial and financial results, as well as provide a general business update. Joining me from MPel this morning is Adrian Adams, MPel's Chairman of the Board and Chief Executive Officer, and Lin Paolo, 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.impelfarma.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. Please advance to slide two, forward-looking statements. I'd like to remind you that during the 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? Thank you, John, and good morning, everyone, and thank you all for joining us. I'm both pleased and excited to update you on the commercial and corporate progress we have made since our first quarter earnings call in May of this year. The agenda for today's call can be seen on our next slide, slide number three. During this call, we will provide a prescription performance update for Tradesa in addition to covering ongoing positive market access, reimbursement, and source of business momentum in the second quarter and year-to-date 2022. We will then briefly review our second quarter and year-to-date financial performance and provide a status update on the market and clinical development opportunity with IMP 105 for the treatment of autism before presenting an overall summary and outlook and then answering some questions from you all. With this said, let's turn to slide number four to begin our commercial performance review. As you can see on this slide, the strong launch trajectory we saw in the first quarter of this year has continued with sustained quarter-over-quarter growth in total prescriptions, a positive trend that continued not only through quarter two, but also into the early part of quarter three. The 48% increase in prescriptions from quarter one to quarter two of this year comes despite a period of softness seen across the whole acute branded market in April and May. We're also delighted to share that at the end of July, cumulative prescriptions passed the 30,000 threshold, reaching 31,193 and marking three straight months of over 20% growth. This consistent upward trajectory with Tradesa prescriptions highlights the clear unmet need that patients persist for people with migraine, patients who need predictable, consistent, and well-tolerated pain relief. Turning now to our next slide, slide number five, we're delighted to see that our average weekly symphony NTRX numbers for Tredesa have not only had an inflection in May, but have continued to accelerate as we have entered and moved into quarter three. We believe this holds well, as we anticipated, for our second half momentum. On the right-hand side of the chart, you will note that Tradesa's share among prescribers is already approaching 5% within the acute branded market, this after only nine months in the market. This upward trend reflects the depth of prescribing we are generating amongst key neurologists and headaches specialists as part of our continued, disciplined, focused, and targeted approach to commercialization. Please now refer to slide number six. With a market as large and dynamic as with migraine, we're extremely pleased to see our sales force continue to execute on a well-balanced effort of expanding the existing prescriber base whilst maintaining high activity among current writers. On the left-hand side of this chart, you can see that our existing prescriber base at the end of the second quarter was 9% higher than the base of new and existing prescribers from the quarter before. indicating that existing writers are satisfied, and importantly, continuing to find new patients for Tradesa. Month by month, we've continued to significantly increase the overall prescriber base by the consistent addition of new prescribers, with this number reaching more than 920 in June. It is also worthy of note that of the almost 1,600 prescribers since launch in October 2021, only 39, or 2.4%, have lapsed, meaning they have gone longer than eight weeks without another new prescription. We believe this loyal prescribing to strong sales execution, a smooth prescribing experience for HCPs, and most importantly, the rapid, consistent, and sustained pain relief to dresser provides for patients. Both the consistent growth of new prescribers and their continued to dresser utilization provides us confidence in accelerated growth in the second half of 2022. As you can see on our next slide, slide number seven, we are pleased to report that the percent of reimbursed prescription shipments of Tradesa has reached new heights, achieving 60% reimbursement so far in the third quarter compared to the 53% and 54% seen in the first and second quarters, respectively. This consistent progress supports our view that Tradesa is a sustainable growth and value-generating engine. And, as we have stated in previous calls, We rapidly secure contracts that cover approximately 80% of commercial lives, a strong market access position, saw soon after launch. We also saw meaningful improvements in gross to net as co-pay support requirements have come down and are pleased with the pair policies being published. The improvements we continue to see in quarter three reflect what we believe is the beginning of a steady improvement in reimbursed prescriptions throughout the second half of 2022. Moving to the right-hand side of this slide, our refill rate has remained both consistent and high at the 64% to 65% level since launch. This is impressive and we believe reflects high patient satisfaction and signals that patients are using Tredesa for more than the occasional severe migraine. The combination of evolving net price and a strong refill rate leads to significant opportunity for value creation. We have maintained that despite new options for those suffering from migraine, patients and physicians are still in search of efficacy. We view the increasing reimbursement and persistent high refill rate as powerful examples of the value Tradesa brings to patients. Turning now to our next slide, slide number eight, the opportunity for continued significant growth of Tradesa comes into view. Symphony data continues to show a high percentage of patients, around 60%, drop off or switch away from GPANS, and more specifically, Nertec and Ubrelvi, at some point in therapy. Given the tolerability of these products, it is our contention that the primary reason for this turnover with GPANS is that prescribers are not finding the rapid, sustained, and consistent efficacy they're looking for in acute migraine treatments. This continued turnover in the market opens up a large pool of eligible patients. We are consistently maximizing this opportunity with Tradesa. Looking at the right-hand side of the slide, you can see that while Tradesa does draw from a broad pool of patients, GPAMs represent the most common previous therapy. Whether replacing a previous therapy or used in addition for specific attacks, we believe physicians are filling an efficacy void with Trudescent. Linking these data to our refill rates, the totality of the trends we are seeing appears to indicate that patients are finding the efficacy and tolerability they desire with Trudescent. Please now refer to our next slide, slide number nine. I'd like to share some qualitative and quantitative data collected by Spheric's Global Insights, a well-respected third-party research organization which provide additional confidence to our views on the growth prospects for Tradesa. This chart from their most recent report predicts continued expansion of both prescribers and market share with Tradesa. Starting at the bottom of the slide, you can see that 52% of current respondents that were surveyed are prescribing Tradesa. And this number is expected to grow over 20% in the next six months. This represents a significant increase and stands in contrast to more established brands that are projected to see either no or minimal growth within the same time period. Focusing on their share of patients, respondents currently use Tredesa in 2.1% of their patients, but expect that to rise to 5% within six months and 12% at peak. For context, just 5%, just 5% of the current Tryptam TRX market would represent peak revenue potential of approximately $500 million. Referring now to our final slide in this commercial review, slide number 10, it is important to note that data remains the driving force behind our goal-to-market and commercial strategy. Volume in the migraine market is highly concentrated among relatively few prescribers. In fact, 75% of all GPAM prescriptions come from only 11,000 physicians, and our focused target base allows for sales promotion in a highly concentrated prescriber base representing 80% of these physicians. Given the potential for Dredessa, we previously discussed plans to expand our sales team to approximately 120 sales representatives in early 2023. we maintain the flexibility to invest into the opportunity should we see the opportunity to accelerate our growth. Our broad payer access, the continued turnover within the acute branded market, and of course the momentum generated by our existing 60% sales team have led us to the decision to expand our sales team by 50% to 90 sales professionals by the end of July. This disciplined investment provides us greater efficiency in reaching and supporting both our super targets and targets. It is important to note that while we've expanded our target list, we remain committed to our targeted strategy, which is focused on high-value neurologists and headache specialists that contribute approximately 40% of the overall migraine prescription market. It is interesting to note that within our now 90-person sales force, we can cover 13% more, now 73%, of the acute branded market. This is remarkably efficient coverage when considering, for example, the close to 600 representatives deployed by Biohaven. With that, I will now turn the call over to John to review our financial results for the second quarter of 2022. John? Thank you, Adrian.