Impel Pharmaceuticals Inc. (NASDAQ:IMPL) Q2 2022 Earnings Conference Call August 15, 2022 8:30 AM ET
Company Participants
John Leaman – Chief Financial & Business Officer
Adrian Adams – Chairman & CEO
Leonard S. Paolillo – Chief Commercial Officer
Conference Call Participants
Ken Cacciatore – Cowen
Laura Chico – Wedbush
Eddie Hickman – Guggenheim Securities
Operator
Good morning, ladies and gentlemen and welcome to Impel Pharmaceuticals’ Second Quarter 2022 Earnings and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later on this call the 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 would like to turn the conference over to Impel’s Chief Financial and Business Officer, Dr. John Leaman, you may begin.
John Leaman
Thank you, Kevin and good morning, everyone. We are delighted that you could join us today for Impel Pharmaceuticals’ quarterly earnings conference call to review our second quarter 2022 commercial and financial results, as well as providing 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, our 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.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. Please advance to Slide 2, forward-looking statements. I would 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. Good morning, everyone and thank you all for joining us. I am both pleased and excited to update you on the commercial and corporate progress we’ve 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 3. During this call, we will provide a prescription performance update for Trudhesa 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 INP105 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 4 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 past the 30,000 threshold, reaching 31,193 and marking three straight months of over 20% growth. This consistent upward trajectory with Trudhesa prescriptions highlights the clear unmet need that patients persists for people with migraine, patients who need predictable, consistent, and well tolerated pain relief.
Turning now to our next slide, Slide Number 5, we’re delighted to see that our average weekly Symphony nTRx numbers for Trudhesa 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 bodes well as we anticipated for our second half momentum. On the right hand side of the chart, you will note that Trudhesa 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 headache specialists as part of our continued, disciplined, focused and targeted approach to commercialization.
Please now refer to Slide Number 6. 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 Trudhesa. 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 1600 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 is the rapid, consistent and sustained pain relief Trudhesa provides to the patients. Both the consistent growth of new prescribers and the continued Trudhesa utilization provides us confidence in accelerated growth in the second half of 2022.
As you can see on our next slide, Slide Number 7, we are pleased to report that the percent of reimbursed prescription shipments of Trudhesa 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 Trudhesa 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 so 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 Trudhesa 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 increasingly reimburses and persistency — persistent high refill rate as powerful examples of the value Trudhesa brings to patients.
Turning now to our next slide, Slide Number 8, the opportunity for continued significant growth of Trudhesa comes into view. Symphony data continues to show a high percentage of patients around 60%, drop off or switch away from Gepants and more specifically, Nurtec and Ubrelvy at some.in therapy. Given the tolerability of these products, it is our contention that the primary reason for this churn over with Gepants is that prescribers are not finding the rapid, sustained, and consistent efficacy they’re looking for in acute migraine treatments. This continued churn over in the market opens up a large pool of eligible patients. We’re consistently maximizing this opportunity with 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 represents 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 Trudhesa. 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 Trudhesa.
Please now refer to our next slide, Slide Number 9. I’d like to share some qualitative and quantitative data collected by Spherix Global Insights, a well-respected third party research organization, which provide additional confidence to our views on the growth prospects for Trudhesa. This chart from their most recent report predicts continued expansion of more prescribers and market share with Trudhesa. Starting at the bottom of the slide, you can see that 52% of current respondents that were surveyed are prescribing Trudhesa 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 same time period. Focusing on their share of patients, respondents currently use Trudhesa in 2.1% of their patients, but expect that to rise to 5% within six months, and 12% at peak. In context, just 5% of the current TRx market will 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 go to market and commercial strategy. Volume in the migraine market is highly concentrated among relatively few prescribers. In fact, 75% of all — 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 Trudhesa, we previously discussed plans to expand our sales team to approximately 120 sales representatives in early 2023. However, we maintained the flexibility to invest into the opportunity should we see the opportunity to accelerate our growth, or broad payer access with continued churn over within the acute branded market and of course, the momentum generated by our existing 60 person 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 neurologist 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.
John Leaman
Thank you Adrian. On our next slide, Slide Number 11 you will see our financial results for the second quarter of 2022. Our net product revenue for the second quarter of 2022 was 2.8 million, up 1 million from the last quarter. Initial shipments of Trudhesa to 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 Trudhesa clinical expenses as the Phase 3 STOP 301 study was closed. This was partially offset by an increase in spend for the clinical development of INP105. 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 and spending to support the commercial and sales and marketing activities for the Trudhesa launch.
Please now refer to our next slide, Slide Number 12. For the first quarter of 2022 Impel 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.
Adrian Adams
Thank you, John. Before closing, I did want to make a few remarks on the market opportunity and projected timings with INP105, a product we are developing for the acute treatments 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 order 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 INP105.
Turning now to Slide Number 14, the INP105 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 pump device to the upper nasal space. The INP105 POD device seen on this slide is preloaded with drug and operated with a single push of a button that gently administer the drug into the nose in a fraction of a second. As with our liquid POD device, coordination of breathing is not required, and the device is intended for administration by either the patient or a caregiver.
In CALM 101 the INP105 Phase 1b clinical study Impel administered 5 mg, 10 mg, and 15 mg doses of INP105 and compared the plasma levels and pharmacodynamic effects of intramuscular injection IM olanzapine and placebo. INP105 demonstrated similar plasma exposure levels on a dose per 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. Impel recently initiated the CALM 201 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 INP105 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 to 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 mg dose of INP105. Impel 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. The 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 Trudhesa’s 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 rates and managed care access provide both the rationale and the opportunity to increase our fair sales force by 50%, bringing us to 90 sales professionals at the end of July. Earlier this year, we provided guidance of between 70,000 to 85,000 nTRx for Trudhesa in 2022, and we remain confident in that guidance range. We are pleased with both the initiation of the CALM 201 study and the potential for INP105 to have a major impact on children and families with at home use. Thank you. I will now open the line up to your value questions. Operator, can you please give the instructions?
Question-and-Answer Session
Operator
[Operator Instructions]. First question comes from Ken Cacciatore with Cowen. Your line is open.
Ken Cacciatore
Hey, good morning, guys. Good initial progress here on this launch. Just wondering if you could speak to the ultimate value for RX. I know, in the past, we’ve looked to Nurtec and Ubrelvy and they were around 400 to 500, it seemed to be a net value to the companies. 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 lawn chair, have you felt good about the patient access that has 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 [indiscernible] or are you 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.
Adrian Adams
Yeah, I’ll take the latter two and then I will 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 is the very, very strong share of commercial lines 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 slides today, we’ve been very, very pleased particular as we 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 Gepants and that be imposed on 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 — in the second half of this year.
I think on sales force, I think it’s a very good question. I think — and we are delighted that again, going back to the key points that I have consistently made, that we anticipated doubling the size of the sales force by the beginning of next year but 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. But 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 precedents from awards and winners in previous organizations. And we’ve been able to recruit not just for the initial 60 but with the new search we’ve brought on Board from a wide variety and we have indeed been recruiting from some of the key players like Biohaven, etc.
So, again I think representatives you well know they chase incentive dollars, they chase the opportunity, so we’re very, very pleased that of the hundreds and hundreds of people who actually applied 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 2022. And Len maybe you could address the first thoughts on value and John may add some points as well. Len.
Leonard S. Paolillo
Sure, sure. Thanks, Adrian. So as you mentioned, Ken we continue to follow the Nurtec 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 Gepants markets, usually requiring a failure of one or two triptans. And we’re starting to see that manifest itself in the coverage as big clients like Caremark and Edna [ph] and their downstream plans have just begun to finalize their policies in the June-July timeframe.
Ken Cacciatore
Thank you.
Adrian Adams
Thank you Ken.
Operator
One moment for our next question. Our next question comes from Eddie Hickman with Guggenheim Partners. Your line is open.
Eddie Hickman
Thanks. Good morning and congrats on the progress guys. How much do you think these new reps manage, like 70,000 to 85,000 scripts 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.
Adrian Adams
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. Then 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 sales force increase by the end of July. So we actually believe that the productivity that’s going to come from that additional 30, we’re already starting to see good signals and not particularly on the new patients and new prescription level, a 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 cycle. 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 that — 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 was 30. So stay tuned. I think again, we’re just executing well against our plan and we feel confident about that, range.
Eddie Hickman
Thanks.
Operator
And one moment for our next question. Our next question comes from Laura Chico with Wedbush. 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? We will go ahead and move on or…
Adrian Adams
Yeah, I think Laura is obviously having some issues, connectivity issues. So we should move on.
Operator
And that was actually the last question that I saw in the queue. So I’m going to turn the call back over to the CEO, Adrian Adams.
Adrian Adams
Alright. 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 the shareholders we serve. We were very confident in the momentum that we’re generating and clearly look forward to our next call. Thank you very, very much.
Operator
Ladies and gentlemen, this concludes today’s presentation. You may now disconnect and have a wonderful day.
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