This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk04: 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 on 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. Now I'd like to turn the conference over to Impel's Chairman and Chief Executive Officer, Mr. Adrian Adams. Mr. Adams, please go ahead.
spk10: 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 from Impel this morning is Lempel Elul, our Chief Commercial Officer, Rajiv Amin, our Corporate Controller, and our new Chief Financial Officer, Michael Cald. Michael brings to Infel an outstanding track record of executive leadership in finance, 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.impelfarmer.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 would like to turn to slide number four, where I will summarize our first quarter and year-to-date performance with Tradesa. 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-tryptan options. Within this market, we have adopted a highly targeted commercialization strategy with a current Salesforce focus on 11,000 target positions made up of predominantly neurologists, headache specialists, and high prescribing primary care physicians. Together, this target group generates 73% of all branded prescriptions. Our journey with Tradesa continues to make consistent progress, and we are pleased to announce first quarter 2023 revenue of $4.4 million, driven by a strong in-market demand of over 18,000 normalized prescriptions, over 70% of which were reimbursed. Importantly, our 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 pulse 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 five to begin our commercial performance review with Trudessa in more detail. As mentioned, on the left-hand side of this slide, we're 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'll note that 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 surge in new patients to provide us with additional competence introduces momentum as we move through the second quarter of this year. Turning now to our next slide, slide number six. 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 at a significantly higher net price. In the first quarter of 2023, we did see a small pullback in normalized TRXs, 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 quick start 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 seven. 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 Tredesa in the first quarter of 2023. just 18 months into the launch of Tradesa. 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 note the significant share gains amongst our top prescribers, who now have Tradesa accounting for 7.6% of their acute branded prescriptions, a clear sign that with continued investment and focus, we believe that Tredesa can achieve the 12% share predicted by neurologists in independent surveys. Please refer to our next slide, slide number eight. You 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're 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 low 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 nine. We continue to monitor the favorable market dynamics and source of business for Trudesa. Symphony data continues to show that a very high percentage of patients, around 60% on G-pounds, specifically Nertec and Uralbin, 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 turnover with GPAMs is that prescribers and IV patients are not finding the rapid, sustained, and consistent efficacy they are looking for in their acute migraine treatments. This turnover in the market opens a large pool of eligible patients, and more specifically, a significant ongoing opportunity for Tredesa. The source of current business for Tredesa remains diverse, with approximately half of new Tredesa patients switching from a triptan and a half from a GPAP. We also note that Tredesa 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. It is against the backdrop of this growing branded market where so many patients still seek efficacy that we are launching our new targeted DTC campaign, Count On It. 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 demonstrate in our phase three, stop 301 trial, Trudessa's ability to deliver efficacy even when taken late into an attack. And for the past 18 months, we have heard patients relate the tremendous impact it 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 treatment of migraine. 2023 is off to a strong start, and I'd 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'd now 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 Trudessa 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 all 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 for the same period of 2022. The increase in SG&A expenses during 2023 is primarily due the ramp up in spending to support Tradesa 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 in the same period in 2022. And finally, as of March 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 showing progress in the near term. With that, I would like to close with our final slide, slide number 12, which provides a summary of the traditional 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 Tradesa in 2022, we remain pleased with the continued performance of Tradesa 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, 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 prescription and share gains with Tradesa among our target positions. Continued evolution of the Tradesa 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 are optimistic of sharing 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 Tudesa 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 value question. Operator, can you please give the instructions?
spk04: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 1-1 again.
spk03: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Stacy Ku with TD Cowan. Your line is open.
spk01: 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 your desk atop 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 if you think about just reminding clinicians to think about prescribing Trieste just given all the benefits? Thank you.
spk10: Well, thank you, Stacey. 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 Trudesa, 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 Trudesa. More specifically, I think this is building on what we've already seen as being increased productivity with the Salesforce. As we articulated on our last call, I think the impact of increasing our Salesforce from 60 to 90 in the kind of July, August period of last year, we've seen a significant kind of productivity and efficiency benefits of that broadening of the Salesforce. And clearly some of the parameters and lead indicators that we've covered today, particularly amongst new patient starts 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 physicians. As I mentioned today, we've broadened that to 11,000 physicians. Not only are we continuing to increase the breadth and depth of prescribing within our existing 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 rolled 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 utility prescriptions in our increased target position populations. So we're very pleased with the evolution that we're 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 Quick Start and the impact on debt price evolution.
spk02: Sure. Thanks, Adrian, and thanks for the question, Stacey. 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 you know, in the first quarter, there's often the highest amount of pressure on your traditional copay, which is the buy-down from a $75 or a $50 copay 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 coinsurance 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.
spk03: Thank you. Thank you, Stacey. One moment for our next question.
spk04: Our next question comes from Eddie Hickman with Guggenheim Securities. Your line is open.
spk12: Hi, good morning, Adrian and Michael. Thanks for taking my questions. So you talked about the post-holiday surgent scripts, the higher reimbursement you're seeing now in the second quarter, and now the CTP 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.
spk10: Yeah, and as we mentioned on the call, we have counsel in reaffirming that to that guidance range and are tracking well towards that. We always knew that the momentum gained in the first and second quarter was going to be really important. And it's that momentum 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 is new patient starts. And seeing the very significant increases in new patient starts 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 that execution focus and disciplined execution is paramount. So that's why we're 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 important, the momentum that we saw strongly in March and as we move through April and into May. So that's what gives us the confidence. And Len, I don't know whether you want to add anything to that.
spk02: No, I think you said it. I think the only additional comment I would make is about the expanding prescriber base, where as we add prescribers, we notice they don't lapse, meaning once they put a patient on Tradesa, it is very rare that they don't continue to prescribe. And so, you know, the expanded sales force and the efforts we make in not only driving deaths, but also gaining new prescribers adds to that confidence because we know they'll continue to prescribe to deaths.
spk12: Got it. And then, you know, it seems to be like the tracking scripts has been pretty consistent, whereas the growth to net seems to be what is fluctuating, you know, in these first couple quarters of launch. And I'm wondering, like, as that gross 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.
spk10: 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 quick start program to drive revenue additional kind of value net price and obviously net revenue growth over the course 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.
spk03: Thanks, Adrian. Actually, my apologies. Someone just queued up for a question. One moment. Our next question comes from Sean Kim with Jones Trading. Your line is open.
spk05: Yeah, 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. you know, compared to the last year's or if you're seeing kind of steady rate on net price. Thank you.
spk10: Thank you, Sean. I'll take the first question. I think, clearly, I think, as we mentioned, I think 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 of 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. Len, you may want to add something to that, but also address the aspects of net price again.
spk02: I think you addressed the DTC components accurately. On the net price evolution, the one lever that we continue to talk about is the quick start of the free goods lever. And as you can see, we're making consistent progress with that as 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 quick start, as we continue to see the easing of the traditional copay burden and the gross to net, we expect to see consistent progress throughout 2023. I do think that we'll see an evolution over 22 for sure.
spk04: Thank you. 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.
spk10: 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.
spk04: Ladies and gentlemen, this does conclude today's presentation.
spk03: You may now disconnect and have a wonderful day. you Thank you. Thank you. We'll be right back. you
spk04: 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 on 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. Now I'd like to turn the conference over to Impel's Chairman and Chief Executive Officer, Mr. Adrian Adams. Mr. Adams, please go ahead.
spk10: 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 from Impel this morning is Len Pellillo, our Chief Commercial Officer, Rajiv Amin, our Corporate Controller, and our new Chief Financial Officer, Michael Cowell. Michael brings to Impel an outstanding track record of executive leadership in finance, 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.impelfarmer.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 would like to turn to slide number four, where I will summarize our first quarter and year-to-date performance with Tradescent. 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-tryptan options. Within this market, We have adopted a highly targeted commercialization strategy with a current Salesforce focus on 11,000 target positions 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 Tradesa continues to make consistent progress, and we are pleased to announce first quarter 2023 revenue of $4.4 million, driven by a strong in-market demand of over 18,000 normalized prescriptions, over 70% of which were reimbursed. Importantly, our 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 five to begin our commercial performance review with Trudessa in more detail. As mentioned, on the left-hand side of this slide, we're 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'll note 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 surge in new patients to provide us with additional confidence introduces momentum as we move through the second quarter of this year. Turning now to our next slide, slide number six. 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 at a significantly higher net price. In the first quarter of 2023, we did see a small pullback in normalized TRXs. 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 quick start 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 seven. 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 Tredesa in the first quarter of 2023. just 18 months into the launch of Tradesa. 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 note the significant share gains amongst our top prescribers, who now have Tradesa accounting for 7.6% of their acute branded prescriptions, a clear sign that with continued investment and focus, we believe that Tredesa can achieve the 12% share predicted by neurologists in independent surveys. Please refer to our next slide, slide number eight. You 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're 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 low 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 nine, we continue to monitor the favorable market dynamics and source of business for Tradesa. Symphony data continues to show that a very high percentage of patients, around 60% on G-pounds, specifically Nertec and Uralbin, 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 turnover with GPAMs is that prescribers and IV patients are not finding the rapid, sustained, and consistent efficacy they are looking for in their acute migraine treatments. This turnover in the market opens a large pool of eligible patients, and more specifically, a significant ongoing opportunity for Tradesa. The source of current business for Tradesa remains diverse, with approximately half of new Tradesa patients switching from a triptan and a half from a GPAP. We also note that Tredesa 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. It is against the backdrop of this growing branded market where so many patients still seek efficacy that we are launching our new targeted DTC campaign, Count On It. 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 demonstrate in our Phase 3, Stop 301 trial, Trudessa's ability to deliver efficacy even when taken late into an attack. And for the past 18 months, we have heard patients relate the tremendous impact it 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 treatment of migraine. 2023 is off to a strong start, and I'd 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'd now 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 Trudessa 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 all 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 for the same period of 2022. The increase in SG&A expenses during 2023 is primarily due the ramp up in spending to support Tradesa 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 from the same period in 2022. And finally, as of March 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 showing progress in the near term. With that, I would like to close with our final slide, slide number 12, which provides a summary of the traditional 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 Tradesa in 2022, we remain pleased with the continued performance of Tradesa 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, the second quarter of 2023. regarding Impel's ongoing priorities in 2023 or execution focus remains on the following key buckets of potential value growth. Accelerating prescription and share gains with Tradesa among our target positions. Continued evolution of the Tradesa 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 are optimistic of sharing 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 Tradesa 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 value question. Operator, can you please give the instructions?
spk04: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 1-1 again.
spk03: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Stacy Kuh with TD Cowan. Your line is open.
spk01: 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 your desk atop 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 if you think about just reminding clinicians to think about prescribing Trieste just given all the benefits? Thank you.
spk10: Well, thank you, Stacey. 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 Trudesa, 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 Trudesa. More specifically, I think this is building on what we've already seen as being 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've seen a 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 starts 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 physicians. As I mentioned today, we've broadened that to 11,000 physicians. Not only are we continuing to increase the breadth and depth of prescribing within our existing 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 rolled 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 utility prescriptions in our increased target position populations. So we're very pleased with the evolution that we're 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 Quick Start and the impact on debt price evolutions.
spk02: Sure. Thanks, Adrian, and thanks for the question, Stacey. 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 you know, in the first quarter, there's often the highest amount of pressure on your traditional copay, which is the buy-down from a $75 or a $50 copay 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 coinsurance 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.
spk03: Thank you. Thank you, Stacey. One moment for our next question.
spk04: Our next question comes from Eddie Higdon with Guggenheim Securities. Your line is open.
spk12: Hi, good morning, Adrian and Michael. Thanks for taking my questions. So you talked about the post-holiday surge in Scripps, the higher reimbursement you're seeing now in the second quarter, and now this DTP campaign starting. So I'm wondering how we should think about the Scripps 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.
spk10: Yeah, and as we mentioned on the call, we have counsel in reaffirming that to that guidance range and are tracking well towards that. We always knew that the momentum gained in the first and second quarter was going to be really important. And it's that momentum 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 continue to be important. And that gets to 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 is new patient staff. And seeing the very significant increases in new patient staff 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 that execution focus and disciplined execution is paramount. So that's why we're focused on these key lead indicators. So we are confident of that guidance range that we've given, and that confidence is based on not only first quarter, but very important, the momentum that we saw strongly in March and as we move through April and into May. So that's what gives us the confidence. And Len, I don't know whether you want to add anything to that.
spk02: No, I think you said it. I think the only additional comment I would make is about the expanding prescriber base, where as we add prescribers, we notice they don't lapse, meaning once they put a patient on Tradesa, it is very rare that they don't continue to prescribe. And so, you know, the expanded sales force and the efforts we make in not only driving deaths, but also gaining new prescribers adds to that confidence because we know they'll continue to prescribe to deaths.
spk12: Got it. And then, you know, it seems to be like the tracking scripts has been pretty consistent, whereas the growth to net seems to be what is fluctuating, you know, in these first couple quarters of launch. And I'm wondering, like, as that gross 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.
spk10: 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 Quick Start program to drive revenue additional kind of value net price and obviously net revenue growth over the course of this year. So clearly I think given that we've gone through the transition quarter and 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.
spk03: Thanks, Adrian. Actually, my apologies. I'm going to just queue for a question. One moment. Our next question comes from Sean Kim with Jones Trading. Your line is open.
spk05: Yeah, 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. you know, compared to the last years or if you're seeing kind of steady rate on net price. Thank you.
spk10: Thank you, Sean. I'll take the first question. I think, clearly, I think as we mentioned, I think 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 of 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. Len, you may want to add something to that, but also address the aspects of net price again.
spk02: I think you addressed the DTC components accurately. On the net price evolution, the one lever that we continue to talk about is the quick start of the free goods lever. And as you can see, we're making consistent progress with that as 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 quick start, 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. I do think that we'll see an evolution over 22 for sure.
spk04: Thank you. 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.
spk10: 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.
spk04: Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.
Disclaimer