Impel Pharmaceuticals Inc.

Q2 2022 Earnings Conference Call

8/15/2022

spk03: 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.
spk06: 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.
spk00: 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.
spk06: On our next slide, slide number 11, you will see our financial results for the second quarter of 2022. The net product revenue for the second quarter of 2022 was $2.8 million, up $1 million from the last quarter. Initial shipments of Tradesit as specialty pharmacies began in September of 2021, ahead of the October commercial launch. Research and development expenses for the second quarter of 2022 were $4 million versus $6.1 million for the same period of 2021. The decrease was primarily due to reduction in Tradesa clinical expenses as the Phase III Stop 301 study was closed. This was partially offset by an increase in spend for the clinical development of IMP 105. Selling, general, and administration SG&A expenses for the first quarter of 2022 were $18.1 million. which compares with $8.9 million for the same period in 2021. The increase in SG&A was due primarily to the ramp up in spending to support the commercial and sales and marketing activities for the Tradesa launch. Please now refer to our next slide, slide number 12. For the first quarter of 2022, MPEL reported a net loss of $25.2 million, or $1.09 per common share, compared to a net loss of $15.5 million, or $1.10 per common share for the same period in 2021. As of June 30, 2022, the company had cash and cash equivalents of $97.8 million, which the company believes will provide sufficient financial resources to fund operations into 2024. With that, I would like to turn the call back over to Adrian to make some additional and closing remarks. Adrian?
spk00: Thank you, John. Before closing, I did want to make a few remarks on the market opportunity and projected timings with IMP 105, a product we are developing for the acute treatment of agitation and aggression in autism. This next slide, slide number 13, provides some background on the autism market opportunity. The unmet need is large and all that continues to grow as the incidence of autism spectrum disorder, or ASD, increases. According to our research, Approximately 600,000 children with ASD display episodes of agitation or aggression. The impact on the children, their families, and caregivers of over 100 million episodes annually is significant, and effective treatment options with favorable safety and tolerability profiles are desperately needed. Currently, clinicians are adjusting daily medications that can lead to unwanted side effects like weight gain, while PRN options require injection administered by a healthcare professional. This dynamic is reflected in the extremely low percentage of severe and even moderate episodes treated with a PRN medication. This is the unmet need opportunity for IMP105. Turning now to slide number 14, the IMP105 is a proprietary formulation of olanzapine specifically designed for rapid absorption after nasal administration. The formulation is designed to be administered as a single spray administered from our dry powder pod device to the upper nasal space. The IMP105 pod device seen on this slide is preloaded with drug and operated with a single push of a button that gently administer drug into the nose in a fraction of a second. As with all liquid pod device, coordination of breathing is not required and the device is intended for administration by either the patient In CARM 101, the IMP105 Phase 1B clinical study, IMFEL administered 5 milligrams, 10 milligrams, and 50 milligram doses of IMP105 and compared the plasma levels and pharmacodynamic effect to intramuscular injection, IM, olanzapine, and placebo. IMP105 demonstrated similar plasma exposure levels on a dose-for-dose basis, but was faster to reach peak levels compared to IM. IMP105 demonstrated onset within 15 minutes with similar or greater effect compared to placebo or IM. IMP105 was well tolerated at all dose levels. IMPAO recently initiated the CALM201 study. This study is a phase 2A proof of concept, two-way, two-period crossover double-blind study to evaluate the safety and efficacy of IMP105 as an acute treatment versus placebo in adolescents with ASD experiencing agitation. Approximately 32 patients with ASD who are currently being treated for agitation aggression at two inpatient units specializing in behavioral treatment will be enrolled. Impel will be observing safety as well as utilizing multiple scales to measure agitation reduction after a 5-milligram dose of IMP105. INFEL expects to complete a pilot phase of the study consisting of the first six patients in quarter four of 2022. This pilot phase will evaluate safety and study feasibility prior to further enrollment. Full study results are expected in the first half of 2023. With that, I would like to turn to our final slide, slide number 15, which summarizes our call today. Impel Pharmaceuticals continues to execute against our key value drivers. Trudesa growth has continued with quarter-over-quarter NTRX growth of 48%. This is powered by a prescriber base that grew by 40% and an increased depth of prescribing that has our NTRX share in that group approaching 5% in just the first nine months of launch. These accomplishments, along with our strong refill rate and managed care access, provide both the rationale and the opportunity to increase our field force by 50%, bringing us to 90 sales professionals at the end of July. Earlier this year, we provided guidance of between 70 to 85,000 NTRX for Tradesa in 2022, and we remain confident in that guidance range. We are pleased with both the initiation of the CAM-201 study and the potential for IMP-105 to have a major impact on children and families with at-home use. Thank you, and we'll now open the line up to your value questions. Operator, can you please give the instructions?
spk03: Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your touchstone telephone. We'll pause for a moment while I compile our Q&A roster.
spk04: Our first question comes from Ken Cagatore with Cowen. Your line is open.
spk02: Hey, good morning, guys. Good initial progress here on this launch. Just wondering if you could speak to the ultimate value per Rx. I know in the past we've looked to Nertec and Ubrelzi, and they were around 400 to 500. It seemed to be a net value to the company. Just wondering if you could just comment. We're seeing nice progress where we think ultimately we're able to top out And then also on patient access, just speak to any changes or refinement you'd need to make on the launch here. Have you felt good about the patient access? Has it been fairly seamless for the ability for them to be able to get their prescriptions? And then just lastly, it's great to hear you're adding to the sales force, maybe any context around the type of folks you're attracting. Are you getting folks from Abzi, are you getting anyone from Biohaven? Just a little bit of a nuance around who you've been able to hire to help execute this next phase. Thanks so much.
spk00: Yeah, I'll take the latter two, and then I'll ask Len to comment on the first. I think from an access perspective, as we mentioned during the call, we've been very, very pleased with two points. One, obviously, the very, very strong share of commercial wires. We were very quickly able to build by the end of last year, 2021. In just three months, as you know, I think we were able to get to an 80% level. Like a lot of companies, we did put in place a bridge program. And again, as we showed in the slide today, we've been very, very pleased, particularly as we've moved into quarter three with our reimbursement rates. We are seeing no issues From a market access perspective, we've got a very, very similar kind of coverage to the G-pounds, and that being post-trip-time failure. So from an access perspective, I think we're very, very pleased with where we are at this particular point in time. I think it bodes well for the momentum in the second half of this year. I think on the sales force, I think it's a very good question. I think we are delighted that, again, going back to the Key point that I've consistently made that we anticipated doubling the size of the Salesforce by the beginning of next year. But that if we saw good momentum and strong opportunity that we would invest into that opportunity. So clearly I think the increase in size by 50% is reflective of that belief and investing into the opportunity. Now, clearly, I think with the initial 60, as you might imagine, I think it is absolutely fundamental to your point that when you bring people into the organization as sales professionals, when you are operating with a very highly targeted approach that you want to make sure that the people you bring in have a very strong track record, a lot of experience in the neurology and migraine space in particular. And we also have very strict criteria in terms of President's Club Awards and winners in previous organizations. And we've been able to recruit not just for the initial 60, but with the new 30 we've brought on board from a wide variety. And we have indeed been recruiting from some of the key players like Byhaven, et cetera. So again, I think representatives, you well know, they chase incentive dollars, they chase the So we're very, very pleased that of the hundreds and hundreds of people who actually apply for a position, we were able to attract the best. So all of this, we believe, bodes well for momentum in the second half of 2020 and 22. And Len, maybe you can address the first point on value, and John may add some points as well. Len?
spk01: Sure. Sure. Thanks, Adrian. So, as you mentioned, Ken, we continue to follow the NERTEC curve, which would have us approximately at a 60% margin or about 510 per script by the end of the year. Obviously, there's going to be a lot of movement in the second half of 2022, which is what we expected. As Adrian mentioned, the 80% of commercial lives that are under contract is the beginning, and then those policies get written in the downstream plans, and we've been very pleased with the utilization management that we've seen, which mirrors our competitors in the GPAMP market, usually requiring a failure of one or two triptans. And we're starting to see that manifest itself in the coverage as big plans like Caremark and Aetna and their downstream plans have just begun to finalize their policies in the June-July time frame.
spk04: Thank you. Thank you, Ken. One moment for our next question.
spk03: Our next question comes from Eddie Hickman with Guggenheim Partners. Your line is open.
spk05: Thanks. Good morning, and congrats on all the progress, guys. How much do you think these new reps may influence that 70,000 to 85,000 script guidance range? That 15,000 script range is pretty wide. So just wondering if you could comment a bit on what needs to happen in the second half to reach the upper versus the lower end of that script guidance range. Thanks.
spk00: Yeah. And again, I think to your point, I think we did reiterate that guidance range. And clearly, I think we always have mentioned that this is very much a second half of 2022 story. The opportunity of obviously being at the, moving up in that guidance range is clearly there. I think as we anticipated, I think we did get a lot of interest in joining the company. I did make reference to, we completed that 30 person Salesforce increase by the end of July. We actually believe that the productivity that's going to come from that additional 30, we're already starting to see good signals in that, particularly on the new patients and new prescription level and new prescriber level. But the productivity aspects of that is really going to start to come through during August and into September, just for the key selling cycles. So I think as we progress, into September, October, we're going to be able to be a little bit more precise in terms of where we're going to end on that range. But just standing back, we're very encouraged not only just with what we're seeing, but obviously the initial productivity we're seeing from most 30. So stay tuned. Again, we're just executing well against our plan, and we feel confident about that range. Thanks.
spk03: And one moment for our next question. Our next question comes from Laura Chico with Redbush.
spk04: Your line is open. Laura, your line is open. You can ask your question. If your line is muted, could you please unmute the line?
spk03: Go ahead and move on, or...
spk00: Yeah, I think Laura has obviously added some issues, connectivity issues, so we should move on.
spk03: And that was actually the last question that I saw in the queue, so I want to turn the call back over to CEO Adrian Adams.
spk00: All right, well, thank you very much, and thank you all for joining us this morning. We look forward to updating you on our continued progress throughout the second half of this year as we continue to create value for patients, healthcare professionals, and, of course, you. We're very confident in the momentum that we're generating and clearly look forward to our next call. Thank you very, very much.
spk03: Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
spk04: The conference will begin shortly. To raise your hand during Q&A, you can dial star 11.
Disclaimer

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