Impel Pharmaceuticals Inc. (NASDAQ:IMPL) Q3 2022 Results Conference Call November 14, 2022 8:30 AM ET
Company Participants
John Leaman – Chief Financial & Business Officer
Adrian Adams – Chairman & CEO
Leonard Paolillo – Chief Commercial Officer
Conference Call Participants
Ken Cacciatore – Cowen
Operator
Good morning, ladies and gentlemen, and welcome to Impel Pharmaceuticals Third Quarter 2022 Earnings and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later in this call a question-and-answer session will be conducted and instruction on how to participate will be given at that time. As a reminder, today’s conference call is being recorded.
And now, I would like to turn the conference over to Impel’s Chief Financial and Business Officer, Dr. John Leaman. Please go ahead.
John Leaman
Thank you, Chris, and good morning, everyone. We are delighted that you could join us today for Impel Pharmaceuticals quarterly earnings conference call to review our third quarter 2022 commercial and financial results, as well as to provide a general business update.
Joining me from Impel this morning is Adrian Adams, Impel’s Chairman of the Board and Chief Executive Officer; and Len Paolillo, Chief Commercial 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.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.
Moving 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?
Adrian Adams
Thank you, John, and good morning, everyone, and thank you all for joining us. I am pleased, as always, to update you on the commercial and corporate progress we have made in quarter three and year-to-date 2022. 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 Trudhesa, in addition to covering ongoing prescriber, market access and patient dynamic data for the third quarter and year-to-date 2022. We will then briefly review our financial performance in addition to providing a status update on the market and clinical development opportunity with INP105 for the treatment of autism. I will then present an overall summary and an outlook for the business going forward before opening the call up for your valued questions. .
With this said, let’s turn to slide number four to begin our commercial performance review with Trudhesa. As you can see on this slide, Trudhesa has continued a consistent and positive launch trajectory with sustained quarter-over-quarter growth in total prescriptions. The 27% increase in prescriptions from quarter two to quarter three comes as we completed the expansion of our sales force footprint from 60 to 90 sales professionals in late July.
We are delighted that cumulative total prescriptions since launch have now reached close to 50,000, with this growth highlighting the clear unmet need that persists for people with migraine, patients who need predictable, consistent and well-tolerated pain relief, a profile that can be delivered with Trudhesa.
Turning now to our next slide, slide number five. We’re also pleased to see that the average weekly Symphony nTRx numbers for Trudhesa increased from an average of 1,245 per week in August to close to 1,500 per week in October. We believe that this inflection in performance is a direct result of our field force expansion with all lead performance indicators relating to new prescribers, new patient starts and consistently high refill rates, all moving in a positive direction. On the right-hand side of this chart, you will note that the Trudhesa market share is now over 5% within the acute branded market among prescribers. This just 12 months into launch of the product.
Please now refer to slide number six, where we will take a closer look at the encouraging early signs related to the clear impact of our sales force expansion. New prescriptions, the key to continued product growth increased by 45% versus the second quarter, signaling a significant acceleration. On the right-hand side of the slide, you will note, we also saw another sizable jump in normalized new Rxs from September to October as we moved into the fourth quarter of this year. Importantly, these clear productivity gains from the sales force expansion go beyond just the number of reps deployed.
With this in mind, please refer to our next slide, slide number seven. As you will see, we have seen an acceleration of new prescription growth across both new and existing territories. In September, on the second month after our expansion was complete, our original 60 territories saw normalized new prescriptions increased 53% compared to the average monthly new patient totals in the second quarter of 2022. At the same time, our 30 expansion territories surged by 38%, again only two months after hitting the field. The smaller territory sizes that resulted from our sales force expansion amplified our targeted approach leading to greater efficiency and higher reach and frequency across all target segments and allowed for significant increases in peer-to-peer education opportunities.
Turning now to slide number eight. On this slide, I would like to highlight the 30% increase in new prescribers when comparing August to October, the three months post sales force expansion to the previous three months. We’re delighted that we have now crossed over 2,000 unique prescribers since launch. And it is also worthy of note that since our launch in October 2021, only 64 or 3% of Trudhesa prescribers have lapsed, meaning they have gone longer than eight weeks without another new prescription, an impressive retention rate compared to other product benchmarks in this space. We believe this loyal prescribing comes from strong sales execution, a smooth prescribing experience for our health care professionals and most importantly, rapid, consistent and sustained pain relief for patients.
Please now refer to next slide, slide number nine. The evolution of our net price continues, driven by the increasing percentage of reimbursed prescriptions with Trudhesa. This now reaching close to 60% versus 53% and 54% in the first and second quarters, respectively. This consistent progress supports our view that Trudhesa is a sustainable growth and value generating asset. Moving to the right-hand side of this slide. The refill rate with Trudhesa has remained both consistent and high, averaging 63% since launch. This is impressive, and we believe, again, reflects high patient satisfaction and signals that patients are using Trudhesa for more than the occasional severe migraine.
Turning now to our next slide, slide number 10. I would like to share some qualitative data collected directly from current Trudhesa patients. These data are consistent with feedback we have received from previous patient research and importantly, with the clinical results seen in our pivotal STOP 301 Phase III study. Indeed, our confidence in the potential for Trudhesa is rooted in the belief that we are changing and improving the lives of those suffering from migraine.
When surveyed on key product benefits, such as rapid onset, consistent pain relief at two hours, tolerability and ease of use, patients reported very high satisfaction scores between 80% to 87%. When compared Trudhesa to the previous therapy, 67% to 74% of patients agreed or strongly agreed that Trudhesa is more convenient, better tolerated, faster working and more effective during a migraine compared to their previous therapy. We have maintained that despite new options for those suffering from migraine, patients and physicians are still in search of efficacy and in light of the patient data we have just shared, the opportunity for continued significant growth for Trudhesa comes into view.
Please refer now to slide number 11. Symphony data continues to show that a very high percentage of patients around 60% drop off or switch away from gepants and more specifically Nurtec and Ubrelvy at some point in therapy. Given the tolerability of these products, it is our contention that the primary reason for this continued churn order with gepants is that prescribers are not finding the rapid, sustained and consistent efficacy they’re looking for in acute migraine treatments. This churn over in the market opens up a large pool of eligible patients and more specifically, a significant ongoing opportunity for Trudhesa.
Looking at the right-hand side of the slide, you can see that while Trudhesa does draw from a broad pool of patients, gepants represent the most common previous therapy, whether replacing a previous therapy are used in addition for specific attacks, we believe physicians are increasingly filling an efficacy board with Trudhesa.
With that, I will now turn the call over to John to review our financial results for the third quarter of 2022. John?
John Leaman
Thank you, Adrian. On our next slide, slide number 12, you will see our financial results for the third quarter of 2022. The net product revenue for the third quarter of 2022 was $3.1 million versus $0.1 million for the same period in 2021. Initial shipments of Trudhesa, specialty pharmacies began in September of 2021 ahead of the October commercial launch. Research and development expenses for the third quarter of 2022 were $3.2 million versus $5.9 million for the same period of 2021. The decrease was primarily due to reduction in Trudhesa clinical expenses, as the Phase III study was closed, partially offset by an increase in spend for the clinical development of INP105.
Selling, general and administrative expenses for the third quarter of 2022 were $19.7 million, which compares to $16.3 million for the same period of 2021. The increase in SG&A was due primarily to the ramp-up in spending to support the commercial and marketing activity for Trudhesa launch.
Turning now to slide 13. For the third quarter of 2022, Impel reported a net loss of $31.1 million or $1.31 per common share compared to a net loss of $25 million or $1.24 per common share for the same period of 2021. As of September 30, 2022, the company had cash and cash equivalents of $79.7 million.
With that, I would like to now turn the call back over to Adrian to make some additional closing remarks. Adrian?
Adrian Adams
Thank you, John. Before closing, I did want to make a few remarks on the market opportunity and projected timing with INP105, a product we are developing for the acute treatment of agitation and aggression in autism.
This next slide, slide number 14, provides some background on this autism market opportunity. The unmet need is large and all continues to grow as the incidence of autism spectrum disorder or ASP 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 the over 100 million episodes annually is significant and effective treatment options with favorable safety and tolerability profiles are desperately needed. This is the unmet need opportunity for INP105.
Turning now to slide 15. INP105, for those of you who may not be aware, is a proprietary formulation of olanzapine specifically designed for rapid absorption at the 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. In CALM 101, a Phase Ib clinical study with INP105 , Impel administered five milligram, 10 milligram and 50 milligram doses of INP105 and compare the plasma levels and pharmacodynamic effect to an intramuscular injection of olanzapine or IM and placebo. INP105 demonstrated similar plasma exposure levels on a dose-for-dose basis, but was faster to reach peak levels compared to IM. INP105 demonstrated onset within 15 minutes with similar or greater effect compared to placebo or IM. INP105 was well tolerated at all dose levels.
We recently initiated a Phase IIa proof-of-concept two-way, two-period crossover double-blind study, the CALM 201 study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescence with ASD experiencing agitation. Approximately 32 patients with ASD who are currently being treated for agitation aggression at two inpatient units specializing behavioral treatments are being enrolled.
Impel will be observing safety as well as utilizing multiple scale to measure agitation reduction after a five milligram dose of INP105. Impel expects to complete a pilot phase of the study consisting of the first six patients in this final quarter of 2022. This pilot phase will evaluate safety and study feasibility prior to further enrollment. Full study results are expected in the third quarter of 2023.
With that, I would like to turn to our final slide, slide number 16, which summarizes our call today. Impel Pharmaceuticals continues to execute against our key value drivers with quarter-over-quarter nTRx growth of 27%. Our prescriber base has increased by 30% and just one year into our launch, we have drawn depth to over a 5% share of the acute branded market within that group. Importantly, the investment we made in our field force expansion is showing rapid results with a 45% increase in new prescriptions and efficiencies seen across both new and existing territories.
Our thoughtful managed contracting and novel distribution network position us to make strategic and measured adjustments to our QuickStart program over the coming quarters. These adjustments are designed to ensure patient access, while evolving our net price in a meaningful and value-added way.
On the development front, we are pleased with the progress of the CALM 201 study and the potential for INP105 to have a major impact on children and families looking for a trusted at whole and as-needed treatment for children and adolescents on this autism spectrum coping with agitation. And finally, in addition to our continued focus on disciplined execution, we are currently assessing a number of financing and strategic opportunities in line with increasing shareholder value over time.
Thank you. And we will now open the call to your valued questions. Operator, can you please give the instructions?
Question-and-Answer Session
Operator
Yes. Thank you. [Operator Instructions] Our first question will come from Ken Cacciatore of Cowen. Your line is open.
Ken Cacciatore
Hi. Adrian and John. Thanks for the question. What’s fascinating to me is going back to slide 11, when you talk about add-on. It’s certainly, as we speak more and more with our clinician consultants, they have a real desire to write it Trudhesa simultaneous with the gepants. They really want to have this available as a rescue is what they often tell us. So just wondering, one, can you just elaborate on kind of the evolution of that. This is, I think, the first time you’re showing a slide like that, which is very helpful.
And then two, can you talk about managed care willingness or where you sit on the formulary to be able to be written simultaneous with another brand? And then also, we did see a little bit of a degradation in the value per Rx. Just wondering if it is — is it supporting that new kind of the sales force push here is that more sampling, if you could kind of address that as well. Thanks so much.
Adrian Adams
Okay. Ken, thank you very much for your questions. I’ll address the first point. I think you’re absolutely correct. I think one of the data points that we continually review is what the source of business is for Trudhesa. I mean, given its efficacy and tolerability profile, we anticipate that physicians would start to use and get experience with the product and post-gepants failures.
What we’ve been very encouraged to see, and this is all we predicted in this marketplace is that given this profile and in particular, given this very high level of churn over with gepants, Nurtec and Ubrelvy in this market, but indeed, the product is being used not only in patients who fell gepants who need that extra efficacy and tolerability, but being used alongside of those products as well.
In addition, we are increasingly starting to see the product being used ahead of gepants as well. So this evolving profile just puts into a perspective in relation to the opportunity with Trudhesa. So I’m very pleased that you’re getting that feedback from physicians and it’s totally in line with both the qualitative and quantitative feedback that we are getting from within the marketplace. On your next point in relation to managed care and value for a prescription, I’m going to ask Len to comment on those please. Len?
Leonard Paolillo
Thanks, Adrian. Ken, most of our contracts are rather silent on the use of Trudhesa with other branded Board of medications. When you talk to clinicians as you have, that is the best practice, it’s called the toolbox approach and most managed care plans are silent on it and, therefore, not restricting the ability to have Trudhesa added on as a rescue when needed to a patient that’s using Nurtec or Ubrelvy as their base therapy.
As Adrian said, I think what you see some patients getting Trudhesa prior to a gepants depending on the patient dynamic. But to date, where we do have any issues at a local level, we’ve had very good KOL support in addressing that utilization management to ensure that patients have access to what they need.
On the net price piece, I think you kind of hit on it. The blend of new patients in Q3 was significantly higher as a proportion of prescriptions versus Q2. And the QuickStart programs are really designed for that smooth prescribing experience to get patients on drug quickly. So for example, if prescription writes — a physician writes a prescription on Tuesday, and we wait for that physician to complete a PA and for the plan to adjudicate. Sometimes that’s just too long for the patient. So we will often ship a QuickStart prescription to make sure the patient doesn’t abandon and if they get the relief that they need. So that higher blend of new patients because of the sales force expansion led to a higher utilization of QuickStart in Q3.
Ken Cacciatore
Great. Thanks so much.
Adrian Adams
Thank you, Ken.
Operator
Thank you. [Operator Instructions] Our next question will come from of [indiscernible] Wedbush Securities.
Unidentified Participant
Hi, everyone. This is [indiscernible] on for Laura Chico from Wedbush. I was wondering if you could comment on refill rates during the third quarter? And what are your expectations heading into 2023 in terms of how this might change? And what are some of the drivers impacting refill rates here? And kind of related to this, what do you envision as the next big drivers for inflection to those are prescribing?
Adrian Adams
Yes. Thank you very much for the question. I think one of the things that we’ve been very pleased with, right from the first month of launch, and as we mentioned, I think we’re now almost one year into the launch, the refill rent has been consistently high at that kind of 60% to 65% level. So clearly, I think if one looks at the most recent data within the quarter, around kind of 63% level. And if you compare that to most benchmarks at this stage of a product launch, that is a very high refill rate.
And clearly, we always see this as being a very important measure because clearly, that’s a direct — sorry, an indirect kind of manifestation of patient satisfaction. So clear — and by the way, that is totally consistent with the results of our Phase III study.
So moving forward, I think we anticipate that as the product gets more and more established and used, that refill rate is going to be maintained over the course of time. And clearly, I think given the efficacy and tolerability profile, that certainly is not a surprise to us. But clearly, it’s very good to be able to see that within the overall marketplace. So again, we see that as being rock solid moving forward. And on your — the second part of your question, I’m going to ask Len to comment on that.
Leonard Paolillo
Sure. In terms of catalysts and inflections going forward, our field force expansion is really just starting to show the benefits. As you heard Adrian talk about, it was a pretty rapid impact. But still, as we sit here in November, the new reps really only have about two months in territory. And so as they are continuing to get appointments booked and continuing to expand their reach and the depth of their frequency, that coupled with what we anticipate to be further investment in awareness-generating activities like very targeted non-personal HCP work as well as DTC in the coming quarters. We think those are all going to pay large dividends, a little more comment on the refill rate. As Adrian said, we do expect that to continue to stay steady throughout 2022, even as PODS per prescription have increased to approximately 6%. We’ve not seen any change in refill rates leading us to believe that patients are using that drug, getting good relief and we’ll continue to refill.
Adrian Adams
Thank you, Len. And obviously, I think Len commented there on the kind of, again, the expansion of the sales force. And clearly, I think we anticipated this. But we always anticipated that the third and fourth quarter of this year would be a very important kind of second half of the initial launch period. So — and clearly, the dynamics in this marketplace where not only are we increasing the number of prescribers but also the new patient increase, I think, as a direct result of the expansion is we’re very, very pleased with that, not only from the fact that, obviously, the platform that it creates for moving into 2023. It creates a very strong platform the growth.
Unidentified Participant
Great. Thank you.
Operator
Thank you. [Operator Instructions] I am seeing no further questions in the queue. I would now like to turn the conference back to Adrian Adams for closing remarks.
Adrian Adams
Okay. Well, thank you very much, everyone, for joining us. It was all a pleasure to have this call, and we look forward to updating you on our continued progress throughout the remainder of this year as we continue to create value for patients, health care professionals and you the shareholders we server. Thank you so much.
Operator
This concludes today’s conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.
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