IMPL - Impel Pharmaceuticals Inc. (IMPL) Q1 2023 Earnings Call Transcript
2023-05-12 11:33:06 ET
Impel Pharmaceuticals Inc. (IMPL)
Q1 2023 Earnings Conference Call
May 12, 2023, 08:30 AM ET
Company Participants
Adrian Adams - Chairman and Chief Executive Officer
Michael Kalb - Chief Financial Officer
Leonard Paolillo - Chief Commercial Officer
Rajiv Amin - Controller
Conference Call Participants
Stacy Ku - TD Cowen
Eddie Hickman - Guggenheim Securities
Sean Kim - Jones Trading
Presentation
Operator
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 in 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.
And now I would like to turn the conference over to Impel's Chairman and Chief Executive Officer, Mr. Adrian Adams. Mr. Adams please go ahead.
Adrian Adams
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 me from Impel this morning is Len Paolillo, our Chief Commercial Officer; Rajiv Amin, our Controller and our new Chief Financial Officer, Michael Kalb.
Michael brings to Impel and ascending track record of executive leadership in pharma, 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'd like to turn to Slide number 4 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've adopted a highly talented commercialization strategy with a current sales force focus on 11,000 target physicians made 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 or 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 PODS per prescription, a solid and high 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 5 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 will know 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, and the second is the post-holiday period, or more specifically in March and April of 2023. It is this latest search in new patients that provide us with additional compass in Trudhesa's momentum as we move through the second quarter of this year.
Turning now to our next slide, Slide number 6. 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 that's a significantly higher net price. In the first quarter of 2023 we did see a small pullback in normalized nTRx, 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, Slide number 7. 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 will know, significant share gains amongst our top prescribers who now have Trudhesa accounting for 7.6% of the few branded prescriptions, a clear sign that with continued investments and focus, we believe that Trudhesa can achieve a 12% share predicted by neurologists in independent surveys.
Please refer to our next slide, Slide number 8. 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 lower 60% range. This increasing reimbursement, together with high refill rates, provide a solid foundation for meaningful revenue growth in 2023.
Turning now to Slide number 9, 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 churn over with gepants is that prescribers and indeed patients are not finding the rapid sustained and consistent efficacy they are looking for in the 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. 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, is against the backdrop of this drawing branded market where so many patients still seek efficacy that we are launching our new targeted DTC campaign camp target [ph]. The campaign highlights the common challenge patients face when taking oral medications. Efficacy is often dependent on taking pills early. But unfortunately life does not always allow that.
We demonstrated in our Phase 3 STOP 301 trial Trudhesa's ability to deliver efficacy even when taken late into an attack. And for the past 18 months we just heard patients relate the tremendous impact 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 treatments of migraine.
2023 is off to a strong start, and I would 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 now would 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 in the same period of 2002. 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. And finally, as of March the 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 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 in 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 prescriptions and share gains with Trudhesa among our target positions, continued evolution of the Trudhesa net price and the resultant positive impact on net revenue growth, securing additional financing to fuel our ongoing commercialization activities and as previously mentioned, we do have ongoing discussions regarding additional capital and our optimistic assuring progress in the near-term and continued interest in aggressive and opportunistic business development.
And then 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 to 110,000, the midpoints of which would represent a 64% growth over 2022.
Thank you. And we will now open the line up to your valued questions. Operator, can you please give the instructions?
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] Our first question comes from Stacy Ku with TD Cowen. Your line is open.
Stacy Ku
Hi good morning. Thanks for taking our questions and welcome Michael to the team. So 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 to 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.
Adrian Adams
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. So we are delighted on being able to roll out this DTC campaign. And 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 has been 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 have seen significant kind of productivity and efficiency benefits of that broadening of the sales force and clearly some of the parameters and lead indicators that we've covered today, particularly amongst new patient stats and obviously prescription evolution and manifestations of that broad efficiency that we've seen.
Now clearly with our targeted strategy, initially it was 8,000 positions. As I mentioned today, we've broadened that to 11,000 positions. 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 roll out over the course of time.
So 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. So we're very pleased with the evolution that we are seeing, but 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.
So 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 that price evolution.
Leonard Paolillo
Sure. Thanks Adrian, and thanks for the question, Stacy. So, 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. And that's going to 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 in the first quarter, there's often the highest amount of pressure on your traditional co-pay, which is the buy down from a $75 or a $50 co-pay 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. So that's going to help also move our net price north as we move through the rest of the year. So we still feel very confident about that $400 to $500 range that you mentioned.
Stacy Ku
Thank you.
Adrian Adams
Thank you, Stacy.
Operator
One moment for our next question. Next question comes from Eddie Hickman with Guggenheim Securities. Your line is open.
Eddie Hickman
Hi, good morning, Adrian and Michael, thanks for taking my questions. So you talked about the post-holiday surgeon scripts, the higher reimbursement you're seeing now in the second quarter and now this DTC campaign starting. So I'm wondering how we should think about the script guidance you provided, and if any of those metrics you think are going to be most important in driving those revenues towards the higher end versus the lower end of that guidance. Thanks.
Adrian Adams
Yes, and as we mentioned on the call, we had council in reaffirming that guidance range, tracking well towards that we always knew that the, the momentum gained in the first and second quarter was going to be really important. And it's that momentum that, that has created the confidence that we have. And clearly I think there are many different lead indicators that are very important in terms of getting you on the right trajectory.
And very importantly, I think not only is building our prescriber base continues to be important, and that gets the essence of our broadened target physician population, which is going very, very nicely in terms of consistent increases in new prescribers. But very importantly, the fuel of prescription growth in new patient starts, and seeing the very significant increases in new patient start that we are seeing, that's going to be the key driver together with the consistently high refill rates that we are building up over the course of time.
So what I've learned in all the different products that I've launched over the course of time is the execution focus and disciplined execution is paramount. So that's why we are focused on these key lead indicators. So we are confident of that guidance raise 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 moved through April and into May. So that thought gives us the confidence. And Len, I don't know whether you want to add anything to that.
Leonard Paolillo
No, I think you said it. I think the only additional comment I would make is about the expanding prescriber base, where the -- as we add prescribers, we notice they don't lapse, meaning they, once they put a patient on Trudhesa, it is very rare that they don't continue to prescribe. And so, 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.
Eddie Hickman
Got it. And then, and it seems to be like the tracking scripts is a pretty, has been pretty consistent, whereas the gross to net seems to be what it's fluctuating, in these first couple quarters of launch. And 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 going to stick with script guidance? Thanks.
Adrian Adams
I think at this point in time, we're going to 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 of this year. So clearly I think given that we've gone through the transition quarter in first quarter, which we're very pleased with the evolution that we've had, then we do feel that at this point in time we want to continue with prescription guidance and clearly we'll continue to reassess that over the course of time. But thank you for the question on that.
Eddie Hickman
Thanks, Adrian.
Operator
And I'm not, actually, my apologies, I'm just queue up for a question one moment. Our next question comes from Sean Kim with Jones Trading. Your line is open.
Sean Kim
Yes. 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? And 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, compared to the last year's or if you're seeing kind of steady rate on net price? Thank you.
Adrian Adams
Thank you, Sean. I will take the first question. I think clearly, I think as we mentioned, I think we -- when again, just stepping back to when we launched, I got a lot of questions over the timing of any DTC activities. So we are very pleased that we've rolled out the count on it program. And 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. So it's a very cost effective disciplined kind of approach to direct-to-consumer advertising.
But all of the statistics point to this being a very effective means of broadening the awareness, and very importantly, broadening the awareness, not only a physician kind of experience, but very importantly the patient's experiences as well. So 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. So Len, you may want to add something to that, but also address the aspects of net price again.
Leonard Paolillo
No, I think you addressed the DTC components accurately. On the net price evolution, the one lever that we continue to talk about is the QuickStart of the free goods lever. And as you can see, we're making consistent progress with that as we make, we've made our adjustments in the first quarter. The other levers of our GTN are quite consistent and stable. And so 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. So I do think that we'll see an evolution over 2022 for sure.
Sean Kim
Okay, thank you.
Operator
And 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.
Adrian Adams
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. So thank you very much and have a good rest of the day and indeed a nice weekend. Thank you.
Operator
Well, ladies and gentlemen, this does concludes today's presentation. You may now disconnect and have a wonderful day.
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Impel Pharmaceuticals Inc. (IMPL) Q1 2023 Earnings Call Transcript