Q1 2022 Kiniksa Pharmaceuticals Ltd Earnings Call
Operator: Good day, and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals First Quarter Warnings Conference Call. At this time, all participants are in a listen-only mode.
Good day, and thank you for standing by and welcome to the <unk> Pharmaceuticals first quarter earnings Conference call. At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require assistance during the conference, please press star zero. I would now like to hand the conference over to Rachel Frank, Head of Investor Relations. Please do so.
Be advised that today's conference is being recorded if you require assistance during the conference. Please press Star Zero I would now like to hand, the conference over to Rachel Frank Head of Investor Relations. Please go ahead.
Rachel Frank: Thank you, operator. Good morning, and thank you for joining Kiniksa's call to discuss our first quarter 2022 financial results and corporate update. A press release highlighting these results can be found on our website under the Investors in Media section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction.
Thank you operator, good morning, and thank you for joining <unk> call to discuss our first quarter 2022 financial results and corporate update press release, highlighting these results can be found in our website under the investors and media section.
Rachel Frank: Ross Moat, our Chief Commercial Officer, will provide an update on our Arkless commercial execution. Then, Mark Ragosa, our Chief Financial Officer, will review our first quarter 2022 financial results. And finally, Sanj will return for closing remarks and to kick off the Q&A session, during which John Paolini, our Chief Medical Officer, and Eben Tessari, our Chief Operating Officer, will also be on the line. Before getting started, please know that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements.
As for the agenda, our Chief Executive Officer, Sean K Patel will start with an introduction Ross note, our chief commercial officer will provide an update on our <unk> commercial execution, Danny marker goes to our Chief Financial Officer will review, our first quarter 2022 financial results.
Lee signs will return for closing remarks and to kick off the Q&A session for which John <unk>, Our Chief Medical Officer, and Evan just sorry, our Chief operating officer will also be on the line.
Rachel Frank: A review of such statements and risk factors can be found on this slide, as well as under the caption, Risk Factors Contained in Our SEC Filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements, except as required by law. With that, I will turn it over to... Thanks, Rachel.
Before getting started please note that we will be making forward looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements.
A review of such statements and risk factors can be found on this slide as well as under the caption risk factors contained in our SEC filings. These statements speak only as of the date of this presentation and we undertake no obligation to update such statements, except as required by law with that I will turn it over to <unk>.
Sanj Patel: And good morning, everyone. I'm really happy to review our first quarter 2022 results today. It's been a full year since the commercial launch of Arclis, a recurrent pericarditis treatment. We're really happy with the progress we've made so far and in bringing Arcalist to patients in need. I'm delighted to report that the net revenue for Arcalist for the first quarter of 2022 was $22.2
Thanks, Rachel and good morning, everyone I'm really happy to review our first quarter 2022 results today, it's been a full year since the commercial launch of our cliffs for recurrent pericarditis.
Really happy with the progress we've made so far and then bringing all cliffs to patients in need.
I am delighted to report that the net revenue for all cliffs, but the first quarter of 2022 was $22.2 million.
Sanj Patel: Ross will cover our commercial performance in more detail, and overall, we've been incredibly pleased with the growth in prescriber adoption, patient adherence, and payer coverage. We're obviously also highly encouraged by the steady commercial growth of Alcalyst to date, and we plan to fully maximize this opportunity. In addition to the launch, we remain focused on helping even more patients and building the most value from across our portfolio of clinical space programs, and these include Vixirilumab, KPL 404, and Mavra Lima Man, starting with Vixorilumab.
Ross will cover our commercial performance in more detail on overall, we've been incredibly pleased with the growth in prescriber adoption patient adherence and payer coverage.
We're obviously also highly encouraged by the steady commercial growth of Barclays to date, and we plan to fully maximize on this opportunity.
In addition to the launch we remain focused on helping even more patients and building the most value from across our portfolio of clinical stage programs and these include the civil and up.
For a full and marvell in the map.
Starting with Venezuela map, we're currently enrolling and dosing in a randomized placebo controlled phase <unk> dose ranging study in Perenco nudge allowed us when we expect data from this study in the second half of this year.
Sanj Patel: We're currently enrolling and dosing in a randomized placebo-controlled phase 2B dose ranging study in Parego nodularis, and we expect data from this study in the second half of this year. For KPL 404, which is our CD40 program, we're enrolling and dosing in a phase 2 study in rheumatoid arthritis. This is a disease where the dose response has been well characterized, and our 12 week study is designed to provide not only PK characterization but also an early signal of efficacy with chronic administration in a well-described patient population. The trial will potentially stand primarily as a proof of concept and could enable optionality to evaluate a range of other autoimmune diseases.
The K P O for a full which is our CD 40 program, we're enrolling and dosing in a phase II study in rheumatoid arthritis. This is a disease, where the dose response has been well characterized in our 12 week study is designed to provide not only PK characterization, but also an early signal of efficacy.
See with chronic administration in a well described patient population.
The trial will potentially stemmed primarily as a proof of concept and could enable optionality to evaluate a range of other autoimmune diseases.
Sanj Patel: For Mavri, we remain highly encouraged by its broad potential, which, as you recall, has been demonstrated by positive clinical data across multiple indications. We're currently evaluating its development in rare cardiovascular diseases where the GMCSF mechanism has been implicated. We also continue to be very active in our business development efforts, which are focused on opportunities that have synergies with our existing commercial infrastructure, as well as the other assets in our pipeline. In essence, we are making tremendous progress across our entire portfolio, and we believe we are well positioned for growth. So with that, I'll turn it over to Ross to review our commercial performance in more detail. Thanks, Sanj.
But marbury, we remain highly encouraged by for potential which as you recall has been demonstrated by positive clinical data across multiple indications were currently evaluating its development in rare cardiovascular diseases, where the GMC FCS GM CSF mechanism has been implicated.
We also continue to be very active in our business development efforts, which are focused on opportunities that have synergies with our existing commercial infrastructure as well as the other assets in our pipeline.
In essence, we are making tremendous progress across our entire portfolio and we believe well positioned for growth so with that I'll turn it over to Ralph to review our commercial performance in more detail.
Okay.
Ross Moat: We're extremely pleased to share with you that Q1 represented continued positive growth in our launch trajectory, generating $22.2 million and close to 20% sequential growth versus Q4. This growth is in spite of the typical seasonal headwinds associated with specialty drugs at the start of the year. Concluding Q1 now gives us 12 months of experience on the market for recurrent pericarditis, and we have generated $60.7 million in net sales since launch today. 2022 will be our first full year of sales, and we are excited by the continued momentum we've generated and the feedback we're gaining from prescribers, payers, and ultimately patients who are experiencing the transformational impact that Alkalyst can bring to this disease We continue to guide to full-year net revenue of between $115 and $130 million.
We're extremely pleased to share with you. The Q1 represented continued positive growth in our launch trajectory generating $22 $2 million and close to 20% sequential growth versus Q4.
This growth is in spite of the typical seasonal headwinds associated with specialty drugs and the start of the year.
Including Q1, now gives US 12 months of experience on the markets recover pericarditis and we have generated $67 million in net sales launch to date.
2022 will be our first full year of sales and we are excited by the continued momentum we've generated and the feedback we gave NIM from prescribers payers and ultimately patients who are experiencing the transformational impact the ALCHEMIST can bring to this disease. We continue to guide to full year net.
Revenue of between 115 and $130 million.
Ross Moat: On slide 8, I will dive into more detail on the drivers behind the recurring pericarditis revenue. Owing to our efforts to enhance the awareness of alkalis, in Q1, we saw a continued increase in the prescribing base. We now have more than 400 individual prescribers, predominantly cardiologists, who have identified and prescribed for at least one recurrent pericarditis patient. Furthermore, we also saw an increase in the absolute number of physicians who have prescribed for two or more patients.
On slide eight I will dive into more detail on the drivers behind the recurrent pericarditis revenue.
Our into our efforts to enhance the awareness of all finished in Q1, we saw a continued increase to the prescribing base. We now have more than 400 individual prescribers predominantly cardiologists, who have identified and prescribed for at least one recurrent pericarditis patients.
Furthermore, we also saw an increase to the absolute number of physicians, who have prescribed for two or more patients repeat prescribers account for around 17% of our ever increasing prescriber base.
Ross Moat: Repeat prescribers account for around 17% of our ever-increasing prescriber base. This demonstrates the continued growth in the breadth of prescribing, as well as the positive experiences physicians and patients are having, resulting in a growing depth of prescribing. On the pay-aside, as I mentioned a moment ago in regard to the typical Q1 seasonality insurance issues, we saw a substantial number of our patient population switch insurance plans in Q1, requiring new approvals and interim support on our free goods bridge program. Nevertheless, we continue to see a very high approval rate across all payer segments, resulting in a 95% approval rate in totality.
This demonstrates the continued growth in the breadth of prescribing as wireless a positive experience as physicians and patients are having resulting in a growing depth of prescribers.
On the payer side as I mentioned, a moment ago with regard to the typical Q1 seasonality insurance issues. We saw a substantial number of our patient population switch insurance plans in Q1.
Requiring new approvals and entrance supports on our free goods breech program. Nevertheless, we continue to see a very high approval rates across all payer segments, resulting in a 95% approval rates in cytometry. Therefore, almost all of these patients came back onto commercial therapy jewelry in the call.
Ross Moat: Therefore, almost all of these patients came back onto commercial therapy during the quarter. In terms of duration, we're just about at the one year stage since our launch, so we have a small cohort of early launch patients who have been on continuous therapy throughout this time. And we continue to see robust adherence, compliance, and timely refill of scripts. We realize we still need more time to determine how long patients will ultimately remain on continuous commercial therapy, but what we do know today is that of those patients who started Arclist in the first launch quarter, around 60% remain on therapy at the end of Q1. While this will continue to evolve, the limited data on hand suggest continuous treatment durations of around 12 months.
Uh huh.
And in terms of duration, we're just about to the one year stage since our launch so we have a small cohort of the early launch patients who've been on continuous therapy throughout this time and we continue to see robust adherence compliance and the timely refill of scripts, we realize we still need more.
Time to.
To determine how long patients will ultimately remain on continuous commercial therapy, but what we do know today is all for those patients who started off list in the first launch quarter around 60% remain on therapy at the end of Q1, while this will continue to evolve the limited data on hand suggests can.
Tenuous treatment durations of around 12 months.
Ross Moat: Additionally, as you can see from the lower right-hand side of this slide, we recently conducted market research on product satisfaction in recurrent pericarditis. We're delighted to hear that patients are experiencing a very high level of satisfaction with Arclis, especially when compared to other treatments that have been prescribed. This speaks well to our ambition of Arclis becoming the standard of care in recurrent pericarditis. Moving to slide 9, we're pleased to see renewed avenues now open for us in disease awareness and promotional activities. For the first time since we launched deep in the COVID-19 pandemic, the main target conferences are now available for the dissemination of data and the opportunity to meet face-to-face.
Additionally, as you can see from the lower right hand side of this slide we recently conducted market research on product satisfaction in recurrent pericarditis and were delighted to hear that patients are experiencing a very high level of satisfaction on August , especially when compared to other treatment and stuff being prescribed this speaks well.
While our ambition of becoming the standard of care in recurrent pericarditis.
Moving to slide nine we are pleased to see renewed avenues now open for us for disease awareness and promotional activities for the first time since we launched deep in the COVID-19 pandemic. The main target conferences are now available for dissemination of data and opportunity to meet face to face.
Ross Moat: In April, we attended ACC, and we made a big splash with a wide audience with our commercial booth, which resulted in over 400 individual conversations with healthcare professionals, and additionally, over 120 delegates attended our Arclis product theatre. We now have ACR and AHA both on the horizon in November, so we're delighted with these opportunities ahead to reach more physicians. The results from research we recently conducted show that following an interaction with our field force, physicians become significantly more aware and knowledgeable about recurrent pericarditis and Arclyst, and, as you see from the bottom right of this slide, their likelihood or intent to prescribe Arclyst in the subsequent months also significantly increases.
In April we attended ACC, and we made a big splash to a wide audience with our commercial booth, which resulted in over 400 individual details with health care professionals and Additionally over 120 delegates intended our oculus product Samsung.
We now have ACR and IHA both on the horizon in November . So we are delighted with these opportunities ahead to reach more physicians.
And the results from research. We recently conducted show the following an interaction with all field calls physicians become significantly more aware and knowledgeable of recurrent pericarditis and darkness and as you see from the bottom right of this slide the likelihood or intend to prescribe uplifts in the subsequent months also.
Difficultly increases.
Ross Moat: Moving to slide 10, I'd like to share more information on how Arclis is starting to become the standard of care for recovering pericarditis. Following the strength of data from our Phase 3 study, Rhapsody, which resulted in 97% of patients experiencing rapid symptom relief, 92% of days with minimal or no pericarditis pain, and a 96% reduction in the risk of recurrence, we are now starting to see key thought leaders in this space publish and contribute to this new and evolving treatment paradigm.
Moving to slide 10, I'd like to share more information on how at least is starting to become the standard of care and become a pericarditis.
Knowing the strength of data from our phase III study Rhapsody, which resulted in 97% of patients experiencing rapid symptom relief, 92% of days with minimal or no pericarditis pain, and a 96% reduction in the risk of recurrence. We are now starting to see key thought leader.
As in this space publish and contribute to the new and evolving treatment paradigm and example of this and a recent publication from our pericardial disease experts published in current cardiology repose emphasize artless as a treatment of choice for recurrent pericarditis, specifically ahead of the use of quarter close.
Ross Moat: An example of this, in a recent publication from a pericardial disease expert published in Current Cardiology Reports, emphasized alkalis as a treatment of choice for recurrent pericarditis, specifically ahead of the use of corticosteroids and even ahead of NSAIDs and colchazine if patients are intolerant. Indeed, this is exactly how we've been positioning Alkalys promotionally, and if we look at the prior treatments our patients have been on, we see that Alkalys is generally being used ahead of steroids, and, in addition, payers are generally not mandating step edits of these non-specific therapies.
Thyroid and even ahead of Nsaids colchicine if patients are intolerant.
Indeed, this is exactly how we've been positioning <unk> promotion and if we look at the prior treatments or patients who've been on we see the Oculus is generally being utilized ahead of steroids and in addition, payers are generally not mandates and step edits of these nonspecific therapies.
Ross Moat: We believe this is acknowledgment from physicians and payers that they are appreciating the steroid-sparing data from Rapsody and the ability for Arconis to specifically inhibit interleukin-1 alpha and beta, which is the underlying driver of recurrent pericarditis. These data set us up well for our anticipated continued growth and how we plan to become the standard of care in helping recurrent pericarditis patients. In summary, on my final slide, we're now one year out from launch, and we have had a cracking start. I'd like to take a moment to thank our fantastic Kiniksa teams in the office and in the field who have worked incredibly hard to bring Alkalys to patients in need.
We believe this is acknowledgment from physicians and payers that they are appreciating the steroid sparing data from Rhapsody and the ability for all finished specifically inhibits interleukin one alpha and beta which is the underlying driver of recurrent pericarditis. These data sets us up well for our anticipated.
<unk> growth and how we plan to become the standard of care and helping with Calvin pericarditis patients.
In summary on my final slide.
Now one year out from launch and we have had a cracking stopped.
I'd like to take a moment to thank all fantastic connects the teams in the office and in the field, who have worked incredibly hard to bring <unk> to patients in need it's rare to have a successful drug launch but to do so in the midst of a global pandemic is an incredible performance.
Ross Moat: It's rare to have a successful drug launch, but to do so in the midst of a global pandemic is an incredible performance. We're delighted that physicians and payers are embracing a new treatment approach, and, of course, we look forward to continuing to support our patients who are providing constant positive feedback on their experience and the improvements they feel while under Arclis treatment. Since launch, we've recorded $60.7 million in net revenue.
We're delighted that physicians and payers are embracing a new treatment approach and of course, we look forward to continuing to support our patients who are providing constant positive feedback on their experience and the improvements they fail under oculus treatments.
Since launch we've recorded $67 million of net revenue we have sets a solid foundation that will empower all growth in the quarters and the years ahead.
Mark Ragosa: We've set a solid foundation that will empower our growth in the quarters and the years ahead. I now hand over to Mark for our financial results. Thanks, Ross. Good morning, everyone.
I'll now hand over to Mark for our financial results Mark.
Thanks, Ross good morning, everyone.
Mark Ragosa: Our detailed first quarter 2022 financial results can be found in the press release we issued earlier today. In the next couple of minutes, I'd like to call your attention to a few items on this slide. First, total revenue in the first quarter of 2022 was $32.2 million and consisted of product revenue of $22.2 million, representing ArcalisNet sales, and collaboration revenue of $10 million, representing the upfront payment from Wodong Medicine for Mabry rights in the Asia-Pacific region.
Our detailed first quarter 2022 financial results can be found in the press release, we issued earlier today over.
Over the next couple of minutes I'd like to call your attention to a few items on this slide.
First total revenue in the first quarter of 2020 to 30.
<unk> $32 2 million and consisted of product revenue of $22 2 million, representing Arcalis net sales and collaboration revenue of $10 million, representing the upfront payment for more Dong medicine for the Maverick blame him for the Maverick rights in the Asia Pacific region.
Mark Ragosa: Of note, the upfront payment of $12 million from Wodong Medicine for arc-less rights in the Asia-Pacific region was deferred and will be recognized over the life of the agreement. Second, operating expenses, which this year also included cost of goods sold in collaboration expenses, were $55.5 million in the first quarter of 2022, compared to $49.3 million in the first quarter of 2021. Third, collaboration expenses in the first quarter of 2022 were $8.3 million and consisted of two obligations to Regeneron, an ARCLIS profit-share expense of $2.3 million and an expense of $6 million, representing 50% of the $12 million upfront payment from Wadong Medicine for ARCLIS rights in the Asia-Pacific region. Fourth, Kiniksa's net loss in the first quarter of this year was $25.2 million, compared to a net loss of $49.5 million in the first quarter of last year.
Of note the upfront payment of 12 million for modern medicine for Arcalis rights in the Asia Pacific region was deferred and will be recognized over the life of the agreement.
Second operating expenses, which this year also included cost of goods sold and collaboration expenses were $55 5 million in the first quarter of 2022.
<unk> to $49 3 million in the first quarter of 2021.
Third collaboration expenses in the first quarter of 2022 were $8 3 million and consisted of two obligations to regeneron and Arcalis profit split expense of $2 3 million and an expense of $6 million, representing 50% of the $12 million upfront payment from what dawn medicine for Arcalis.
Writes in the Asia Pacific region.
Fourth connected net loss in the first quarter of this year was $25 2 million compared to a net loss of $49 5 million in the first quarter of last year.
Mark Ragosa: 5th 1st quarter 2022 financials do not reflect the net cash impact from our collaboration with Huadong Medicine, and we ended the period with cash reserves of approximately $145 million. And finally, we expect total 2022 ARCLIS net revenue of between $115 and $130 million. And based on our cash reserves, as well as continued ARCLIS commercial execution, we expect to be able to fund our current operating plan into at least 2024. With that, I'll turn the call back to Sanj for closing remarks. Thanks, Mark. In essence, it's a really exciting time for Kiniksa.
The first quarter of 2022 financials do not reflect.
The net cash impact from our collaboration with what Don Medicine, and we ended the period with cash reserves of approximately $145 million.
And finally, we expect to total 2022, Arcalis net revenue between 115 and $130 million and based on our cash reserves as well as continued arcalis commercial execution, we expect to be able to fund our current operating plan into at least 2024.
With that I'll turn the call back to <unk> for closing remarks.
Thanks, Mark in essence, it's a really exciting science of connect.
Sanj Patel: In addition to the successful start and commercial launch in recurrent pericarditis, we're also building a foundation as an emerging leader in immune modulating therapies. On the commercial side, you've heard where revenue is coming from, and after only three quarters, the Arklays collaboration is already profitable. Looking to the rest of the year, we've guided, as Ross said and Mark, an estimated net revenue of $115 to $130 million, which would represent more than 200% growth year over year.
In addition to the successful style and commercial launch in recurrent Pericarditis. We're also building a foundation is an emerging leader in immune modulating therapies.
On the commercial side, you've heard where revenue producing and after only three quarters. The aldcliffe collaboration is already profitable.
Looking to the rest of the year, we guided as Ross said, a knock and estimated net revenue of $115 million to $130 million, which would represent a more than 200% growth year over year.
Sanj Patel: We've got a near-term milestone coming up with the data from the Phase 2b trial of VIXA in the second half of this year. We're also enrolling in a Phase 2 proof-of-concept study in RA with our CD40 program, and this could provide additional optionality for a range of autoimmune diseases. As I said earlier, we're also utilizing the data from our MAVRI program to evaluate rare cardiovascular diseases that have synergies with our existing cardiovascular commercial infrastructure.
We got a near term milestone coming up with the data from the phase <unk> trial of VIX in the second half of this year. We're also enrolling in the phase II proof of concept study in a ray without CD 40 program and this could provide additional optionality for a range of autoimmune diseases.
As I said earlier, we're also utilizing the data from our <unk> program to evaluate rare cardiovascular diseases that have synergies with our existing cardiovascular commercial infrastructure.
Sanj Patel: Importantly, as Mark just said, we're well capitalised and have cash reserves expected to fund our operating plan into at least 2024. The bottom line is, we have no need to raise additional capital at this point, and we continue to drive our portfolio forward. As I mentioned earlier, we're also very interested in potentially augmenting our pipeline with additional assets through our business development activities. That remains a key focus.
Importantly, as Mark just said, we're well capitalized and have the cash reserves to fund our operating plan into at least 2020 for.
The bottom line is we have no need to raise additional capital at this point and we continue to drive our portfolio forward.
As I mentioned earlier, we're also very much interested in potentially augmenting our pipeline with additional assets through our business development activities that remains a key focus.
Sanj Patel: Ultimately, we are determined to continue to help patients in need, help create massive value, and aim to fulfill our goal of becoming a generational company. With that, I want to thank you for your time today, and I'll hand it back to the operator to open up for questions. Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, please press the pound key.
Ultimately we are determined to continue to help patients in need.
Create massive value and aim to fulfill our goal of becoming a generational company without I want to thank you for your time today and I'll hand, it back to the operator to open up for questions. Thank you.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key please standby will be compile the Q&A roster.
Operator: Please stand by while we compile the Q&A roster. And our first question comes from the line of Anupam Rana with J.P. Morgan. Your line is open.
And our first question comes from the line of <unk> with J P. Morgan Your line is open.
Anupam Rama: Hey guys, thanks so much for taking the question. A quick one from me. I know you said that you have 400 prescribers plus right now, which has grown from 300 plus in the 4Q update. What portion of your target prescribers have you penetrated? I guess I'm trying to understand where the new scripts will be coming from.
Hey, guys. Thanks, so much for taking the question a quick one for me I know you said that you have 400 prescribers plus right now which has grown from 300 plus in the in the Fork you update what portion of your target prescribers have you penetrated I guess I'm trying to understand where the new scripts will be coming from <unk>.
Anupam Rama: Will they be coming from new prescribers or repeat prescribers? And then a second question, which is, can you remind us how long an initial script is written for? You know, we've heard some patients on Anakinra for, you know, 12 to 24 months. So how do you think about 60% of patients on therapy from 2Q21 staying on therapy here in year two? Thanks so much.
Would be coming from new prescribers or or repeat prescribers and then a second question which is.
Can you remind us how long an initial script is written for we've heard some patients on anakinra from.
12 to 24 months. So how do you think about that 60% of patients on therapy from from <unk> 'twenty, one staying on therapy here in year two thanks, so much.
Ross Moat: Thanks Anupam. Ross, do you want to start with that, and myself or John or Eva can jump in? Yeah, very happy to. Hi Anupam, this is Ross.
Thanks, Russ do you want to start with that and myself or John can jump in.
Ross Moat: So you're absolutely right; we've got more than 400 individual unique prescribers of Arclis so far in recurrent pericarditis, and that's grown substantially since our time of launch, around 100 or more than 100 in every quarter since we launched with a growing depth of prescribing, currently 17% roughly of the 400 base. So we're very pleased with that.
Yes, very happy to Hi, Andy Pam This is Rob so you're absolutely right as we have since gone more than 400.
Individual unique prescribers of <unk> farm become apparent at IHS, that's grown substantially since that time of launch around 100 or more than 100 in every quarter since we launched with the growing depth of prescribing.
17% roughly of the 400 basis.
Ross Moat: In terms of your comments around whether it's kind of a target physicians or not, I mean, most of the prescribing is coming from our current target base. As you know, we spent a lot of time prior to launch really understanding who we're looking after, which physicians and which centers are looking after recurrent pericarditis patients. And we have a highly targeted approach around that. I am very pleased to see that the majority is coming from the target base.
Very pleased with that in terms of your comments around the whether it's kind of a target physicians are not I mean, most of the prescribing is coming from our current target basis. As you know we spent a lot of time prior to launch really understanding who would look at all of which positions on which centers on looking after becoming pericarditis patients and we have a highly targeted approach around that.
So we're very pleased to see that the majority is coming from the <unk>.
Ross Moat: Although we also recognize that we're not reaching all of the recurrent pericarditis patients across the US with our targeting strategy. So non-personal promotion continues to be incredibly important to us, as do the contacts that we make at congresses and through other routes as well. So there is a mixture of non-target prescribing as well, but to a much lesser extent. In terms of the duration, your 12-month prescription comment is right. We see that the majority of prescribers prescribe Arclis for 12 months as an initial script.
Ill get base, although we also recognize that we're not reaching all of the recurrent pericarditis patients across the U S with all targeting strategies.
Non personal promotion continues to be incredibly important to us as does the contacts that we make at Congresses and to all the other routes as well. So there is a mixture of non targets prescribing as well, but to a much lesser extent.
In terms of the duration.
12 months description comments is right, we see that the majority of prescribers prescribe office for 12 months is an initial a script.
Ross Moat: Some obviously prescribe for less than that as well, often indicating that they may want to see the patient in the clinic after a three-month or six-month time period, particularly when they're new to prescribing Arclis, and they may renew the prescription after that.
Obviously prescribed for less and nuts, as well often indicating that they might want to see the patient in the clinic. After a three month or six month time period, particularly when use of prescribing heartless and they may renew that prescription prescription after that but yes. The majority are 12 months.
Ross Moat: But yes, the majority are 12 months. Linked in with that as well, the majority of payer approvals are also for 12 months before requiring a reauthorization of that approval. So that kind of bodes well also for the potential duration. And as we said, around 60% of those Q2 early launch patients were still on therapy through the end of Q1, which again kind of builds into the confidence of duration potentially being around 12 months.
Linked in with us as well the majority of the payer approval was also for 12 months before requiring.
Authorization.
I'll start off that approval, so that kind of bodes well so to the potential duration and as we said around 60% of those Q2 early launch patients were still on therapy through the end of Q1, which again kind of builds into the the confidence.
Duration potentially being around 12 months, although acknowledging this is small cohorts of the data will continue to evolve.
Ross Moat: Although acknowledging it's a small cohort, the data will continue to evolve, and we need to see a more robust number of patients get into that time point and wait to see what the right-hand side of that curve looks like over time to be able to provide more information around the actual, eventual treatment. Thanks so much for taking our questions. Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
And we need to see more robust number of patients gets into that time points and wait to see what the right hand side of that curve looks like over time its about to provide more information around the actual eventual duration.
Yes.
Thanks, so much for taking our questions.
And some of them.
Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Hi, thank you. Good morning. Good morning.
Hi, Thank you good morning, good morning, and congratulations on the progress here I was wondering if you can maybe elaborate a little more on your comments regarding Q1 payer dynamics on how we should think about arcalis dynamics in the future here in Q1, how much of it was.
Paul Choi: And congratulations on the progress here. I was wondering if you could maybe elaborate a little more on your comments regarding Q1 pair dynamics and, you know, how we should think about Arcalist dynamics in the future here in Q1, how much of it was, I guess, due to the new RP indication versus continual processing versus caps, which I think, you know, have, of course, been on the market for a while. Yeah, Paul, so this is Ross again.
I guess what was due to the.
The new RP indication versus continual processing versus caps, which I think has of course been on the market for a while.
Okay.
Ross Moat: So yes, the vast majority of the comments there around recurrent pericarditis, CAHPS, obviously continues, as does DIRA, and we continue to support those patients through our patient services program in exactly the same way as we do with recurrent pericarditis. But I think now at this stage of our launch, 12 months out, the vast majority of patients that are on our list are now experiencing recurrent pericarditis, as opposed to the other two indications.
Yes.
This is Ross again, so yes, the vast majority of the common sorry around retirement pericarditis caps, obviously continues as does DRAM and we continue to support those patients through our patient services program in exactly the same way as we do with recurrent pericarditis, but I think now at this stage of our launch 12 months out.
The vast majority of patients which are on our pledge to now in recurrent pericarditis opposed to the other two indications say this.
More grainy associated with recurrent pericarditis.
Ross Moat: So that's more closely associated with recurrent pericarditis. And yeah, for Q1, payer dynamics, I mean, it's really down to the payer plans and people changing insurance and supporting people through Bridge whilst they get the approvals under the new insurance plans, as well as, you know, renewed co-pay payments and, you know, increasing Kiniksa support around that to help patients through that. We see the Q1 dynamics or headwinds there as transitory, and we expect things to kind of return to normality in Q2 and beyond. Okay, thanks for that, Ross.
And yes for the Q1.
Payer dynamics I mean, it's really down to the.
The payer plans and people change in insurance and supporting people to bridge once they get the approvals under the new insurance plans as well as renewed copay payments.
Creasing the connector supports around that too to help patients through that time points as well. So we see the Q1 dynamics or headwinds that is transitory.
We expect things to kind of return to somewhat normality in Q2 and beyond.
Paul Choi: And then there is one pipeline question with regard to VIXA. I guess, you know, given the data's coming up here in the second half of the year, can you maybe just sort of frame, you know, as to what would be a competitive result in, you know, given what is a somewhat crowded landscape and just how you're thinking about what areas you'd focus on for differentiation versus some of the other sort of clinical stage assets in the category? Thank you very much. Thanks, Paul. John, do you want to start, and maybe Eben can jump in?
Okay. Thanks for that Ross and then one pipeline question with regard to Victor I.
I guess given the data is coming up here in the second half of the year can you, maybe just sort of frame as to how you would think about what would be a competitive result.
Given what is.
What.
Crowded landscape and just how youre thinking about what areas you would focus on four for differentiation versus some of the other sort of clinical stage assets and the category. Thank you very much.
Thanks, Paul John do you want to start and maybe even jumps in.
John Paolini: Sure, happy to do so. And thanks for the question, Paul. Good morning to you.
Sure happy to do so and thanks for the question Paul Good morning. So.
So yes, so as you remember the phase Iia study already demonstrated proof of concept to VIX rolling up in Prurigo <unk> in terms of the primary and secondary endpoints being highly statistically significant but also with clinically meaningful outcomes in terms of reduction of pruritus as well as lesion resolution. So the purpose of the phase II.
John Paolini: So yes, as you remember, the Phase 2a study already demonstrated proof of concept for Vixirelinab and Pariago nodularis in terms of the primary and secondary endpoints being highly statistically significant, but also with clinically meaningful outcomes in terms of reduction of paritis, as well as lesion resolution. So the purpose of the Phase 2b study is really just to test for practical monthly subcutaneous dosing. And that's the purpose of this study with 180 patients.
<unk> study is really just to test for practical monthly subcutaneous dosing and Thats. The purpose of this study with 180 patients.
John Paolini: So in that sense, we will gather important information over 16 weeks with regard to reduction in pruritus, as well as follow patients longer in terms of lesion resolution, which, as you know, Victorella MAT has a dual mechanism of action, blocking not only interleukin 31, which is implicated in pruritus, but also blocking oncostatin M, which has been implicated in hyperkeratosis and fibrosis.
So.
In that sense, we will gather important information over 16 weeks.
With regard to reduction of pruritus as well as following patients longer in terms of lesion resolution, which as you know VIX Gorilla math has a dual mechanism of action walking not only interleukin 31, which is implicated in pruritus, but also walking Arca status.
Which has been implicated in hyperkeratosis in fibrosis, so that dual mechanism. So I'll turn it over to Evan to talk about the competitive landscape. Thank you.
Eben Tessari: So that dual mechanism. Now, I'll turn it over to Eben to talk about the competitive landscape. Thank you. Yeah, thanks, John. And maybe I'll just add that, you know, we think that if we are able to replicate the results of our phase 2a study with the monthly dosing of the 2b program that we're currently running, Vixor Elimab is incredibly well positioned, given the data we've generated to date versus the two main other competitors in the field. Great, thank you.
Eben Tessari: Thank you. Our next question comes from the line of David Nierengarten with Wedbush Securities. Your line is open.
Yes, Thanks, John maybe I'll just add that.
We think that if we are able to replicate the results of our phase Iia study.
With the monthly dosing out of out of the <unk> program that we're currently running Victor all about moving incredibly well positioned given the data we've generated to date versus.
The two main other competitors in the field.
Great. Thank you.
Thank you. Our next question comes from the line of David Nearing Garden with Wedbush Securities. Your line is open.
David Nierengarten: Hey, thanks for taking the question. Congratulations on the profitable franchise. It's really cool to see.
Hey, Thanks for taking my question and congrats on a profitable franchise historical let's say.
David Nierengarten: Just a couple of questions on commercialization, patient turnover, you know, are there, or do you have a handle on any of the patients who are essentially, I hate to use the word, but feel they're cured or feel that they won't have a recurrence and so have dropped off therapy? And then on a related note, are there patients, or do you have a better handle, maybe I should say, on the proportion of patients coming in who might have pre-existing conditions that really prevent them or would prevent them from going on steroids or some of the other treatments that are used? And so, you know, these, maybe they're not.
Just a couple of questions on the commercialization the.
The patient turnover.
Either.
Or do you have a handle on any of the patients who are essentially.
I hate to use the word, but still they're cured or fulfill that they won't have a recurrence and so have dropped off therapy and then on a related note.
Are there patients.
Or do you have a better handle.
I'd say on the proportion of patients coming in who might have.
Pre existing conditions that really.
Prevent them are wood.
Im doing on steroids or some of the.
Other treatments that are used and so.
Maybe they're not.
David Nierengarten: Long-term recurrent patients, but they have, you know, their first episode, and the doctor notices they have underlying conditions that aren't amenable to, you know, treatment with steroids. And so they go on. Hi David, this is Ross.
Long term recurrent patients, but they have.
Their first episode.
And then the Doctor notices they have underlying conditions that arms are met.
Bolton treatment with steroids in subsequent months.
Markwest.
Ross Moat: So maybe I can start on those two questions. Firstly, on patient turnover. So yes, since the time of launch, obviously, we've seen some patients that have stopped therapy, whether that's through the physician believing that they are, you know, they came in at a particular time point in their disease, and they needed a shorter duration and then trial to stop, or whether it's through, you know, the patient's belief that they are, you know, somewhat over the condition, and able to try to stop as well.
Yes, Hi, David This is Rob maybe I can take his thoughts on those two questions. So firstly around the patient turnover.
Since the time of launch obviously, we've seen some patients have stopped therapy, whether that's through the physician believes that they are they came in a particular time point in their disease and they needed the shortage situation and then tried to stop or whether it's through the patient's belief that they are somewhat over the condition and able to try to stop as well.
So we've seen that to some degree although I think the percentages kind of showed that most patients remain on therapy for a longer time period.
Ross Moat: Although I think the percentages kind of show that, you know, most patients remain on therapy for a longer time period. And, you know, ultimately, we also see patients that are coming back and restarting on therapy as well if they have a trial to stop. And, you know, in recurrent pericarditis, what happens is, symptoms will come back pretty rapidly and aggressively if the duration is too short.
And.
We also see patients coming back and restarted on therapy as well if they have trial to stop and recurrent pericarditis. What happens is symptomology will come back pretty rapidly and aggressively if situation is too short.
And then we know from the Rhapsody data as well as well publish that patients can restart home therapy, if they do get symptoms again, if we come in pericarditis, so entering into another flat so.
Ross Moat: And then we know from the Rhapsody data as well, it's well published, patients can restart on therapy if they do get symptoms again of recurrent pericarditis or enter into another flare. So we've seen several patients restart on therapy as well. So it's good that physicians and patients know that as a safety net, I guess, if they do stop therapy too early, but ultimately, the mainstays for physicians are to really judge, based upon the baseline characteristics of the patients, and you know the cadence and severity of their flares, what the appropriate duration would be for the patients and try to guide them toward the natural history course of the duration of the disease and matching treatments against it.
Several patients restart on therapy as well as good that physicians and patients know that as a safety net I guess, if they if they do stop therapy too early.
But ultimately in the mainstays for the physicians to really judge based upon the baseline characteristics of the patients.
The cadence and severity of that class, what the appropriate duration would be full for the patients and try to guide them towards the natural history core sales day of the duration of the disease.
Matching treatments against that.
Ross Moat: On the side of patients who have pre-existing conditions kind of preventing them from using steroids, it's not something that we've looked at a huge amount. I mean, I think it's widely acknowledged that steroids are probably not the best solution for this type of disease. We also know that, you know, the toxicity effects of being on long-term steroids or high doses of steroids can be very detrimental to patients.
On the sides of the proportion of patients who have preexisting conditions kind of prevented them from steroids.
Not something that we've looked at a huge amounts I mean, I think its widely acknowledged that steroids are probably not the best solution for this type of disease and we also know that.
The toxicity effects have been on long term steroids. So high dose steroids can be very detrimental to patients is also well publish that being on steroids.
Ross Moat: It's also well-published that being on steroids increases the risk of recurrence when you take patients off the steroids and really... Yeah, go back to square one for these patients. So we want to avoid that. And I think that's what we're seeing is becoming more and more commonplace in the field since the time of launch. People are understanding that steroids are not the best treatment answer here, and alkalis targets the root cause of the disease. So generally, it's not because of preexisting conditions but more so understanding the underlying mechanism of action of the disease and alkalis as a treatment addressing that, I guess.
Increases the risk of recurrence when you take patients off the steroids.
And really.
Go back to square one for these patients. So we want to avoid thoughts and I think thats what were seeing is becoming more and more commonplace in.
In the field since the time of launch people are understanding the steroids and all the best treatment answer here and artless targets because of the of the disease.
Generally, it's not because of preexisting conditions, but more so understanding the underlying mechanism of action of the of the disease and all classes of treatments addressing that and getting patients onto the right treatments first time round.
Ross Moat: And then maybe one quick follow-up on sales and marketing. Do you anticipate any additional spend, incremental spend, to continue to market Arcalis maybe to the less frequent prescribers or just you know patients who you know maybe are more on the acute side of things rather than you know two or three recurrences? Yeah, so maybe I'll make a start on that.
And then maybe one quick follow up.
On the.
Sales and marketing do you anticipate.
Any additional.
<unk> spend incremental spend too.
He will continue to market.
<unk> maybe to.
To the.
Less frequent prescribers are the patients who maybe are more on these acute side or are things sort of towards the recurrences.
Ross Moat: I don't know if Mark or anyone else wants to jump in, obviously, please feel free to do so as well. So, I mean, ultimately, it's something that will always be under evaluation. We're always looking at the best, most efficient way of addressing the opportunity. And we did a lot of work prior to launch to get, you know, the field team in right and the non-personal promotion side of things correct so we could reach as many recurring pericarditis patients as possible. We've always had a very methodical, data-driven approach to how we approach the market.
Yeah, So maybe I'll make his thoughts on that node Moscow anyone else wants to jump in and obviously, please feel free to do so as well. So I mean, ultimately something that will always be under evaluation. We are always looking at the best most efficient way of adjusting the opportunity and we did a lot of wildfire to launch to get the field team invites and the non personal.
Promotion side of things correct. So we could reach as many becoming pericarditis patients as possible. We've always had a very methodical data driven approach and how we address the market. So its something we constantly look at.
Ross Moat: So it's something that we constantly look at. And, you know, whether that means in the future, maximising more non-personnel promotion opportunities, more Congresses, looking at the field team, and many other areas, then we will obviously always continue to look at that and make sure that we're driving value for patients and for Kiniksa and for all our stakeholders. I think you said it very well, Ross. I mean, the bottom line is obviously we're very excited about the opportunity, clearly it's a growing opportunity, and we're doing a lot of analytical work right now and will continue to look at it, but it's been a great experience. Bernard Keefe, Chairman, Association of Pharmaceutical Scientists of the Equality, Quality, and Sustainability Management firm Iavecoom Co. Ltd, S. Our next question comes from the line of Jeff Meacham with Bank of America. Your line is open. Hi, this is Alex Hammond on behalf of Jeff Meacham.
Whether that means in the future.
<unk> more non personal promotion opportunities more Congress is look into the field team of many other.
Areas, then we would obviously always continue to look at that to make sure that we're driving value for <unk> and for patients and for connect stakeholders.
Our stakeholders.
I think you said it very well Ross I mean bottom line is obviously, we're very excited about the opportunity clearly, it's a growing opportunity.
We're doing a lot of analytical work right now and continue to look at it but it's been a great.
Set of execution on.
On the commercial side. So we'll just continue to looking at that but I think you're definitely right and there is increasing opportunity and so we're very much focused on that.
Alright, thank you.
Okay.
Thank you. Our next question comes from the line of Geoff Meacham with Bank of America. Your line is open.
Hi, This is Alex on for Geoff Meacham. Thank you for taking our question.
Geoffrey Meacham: Thank you for taking our question. So, given you have cash to get you to 2024, can you provide any additional color on your BD strategy? Have the depressed mid-valued valuations changed your appetite at all? And what qualities are you looking for in assets besides just being in your general wheelhouse? Thank you so much.
So given you have cash to get you to 2024 can you provide any additional color on your BD strategy.
Pressman valuations change your appetite at all and what qualities are you looking for in assets.
And your general Johan Thank you so much.
Sanj Patel: Thanks, Alex. Maybe I'll make a couple of comments, and Eben, feel free to jump in. But, you know, obviously, as you said, we feel great about the cash position, which allows us to get into at least 2024. And, you know, obviously, that's relying on our continued commercial execution as well. But on top of that, you're right, it's clearly, It's very obvious right now that there are a lot of depressed valuations out there, technologies that are all part of our under, Trading Below Cash.
Thanks, Alex maybe I'll make a couple of comments and then feel free to jump in but obviously as you said, we feel great about the cash position, which allows us to get into at least 2024.
And obviously, that's relying on continued commercial execution as well, but on top of that you're right. It's clearly.
It's very obvious right now that it is not with depressed valuations out there and channel et cetera, all products around that.
Sanj Patel: So we're certainly very keen to look at ways to augment our pipeline. We've got some great products that are in the modulating space, but there are technologies or products that we could add. So we're looking at that very keenly. Ideally, it would be great for it to be able to have synergies with our existing commercial infrastructure, as well as our development pipeline as well. But we've got a team here that's very
Trading below cash so we're certainly very keen to look at ways to augment our pipeline. We've got some great products that are in the immune modulating space, but there are technologies or products that we could add so we're looking at that very keenly ideally it would be great for it to be able to have synergies with our existing commercial infrastructure as well as our development pipeline as well.
But we've got a team here, that's very adaptable, obviously, a lot of rare disease experience, but now obviously with full year of the commercial execution on event. We've shown that we can execute commercially as well. So we're looking across the various stages of development for products and technologies.
Sanj Patel: Obviously, a lot of rare disease experience, but now, obviously, with a full year of commercial execution and events, we've shown that we can execute commercially as well. So we're looking across the various stages of development for products and technologies. And it's certainly an exciting time for a team like ours that, as you know, created this franchise and this company in just around six years from a blank piece of paper, primarily through business development.
And it's certainly an exciting time for it seem like cause as you know created this franchise in this company and just around six years from a blank piece of paper.
Sanj Patel: We do have our own research as well, looking at early stage programs. Most of those are in the immune modulating space, but we're open to looking at other rare diseases and other opportunities where we can bring value and ultimately execute. And having the cash is nice.
Not only through business development, we do have our own research as well looking at early stage programs. Most of those when you mean modular space, but we're open to looking at other rare diseases and other opportunities, where we can bring value and.
And ultimately execute.
Sanj Patel: So we'll be very judicious. Capital allocation is very important to us. But obviously, having values that are realistic as well is important too.
And having the cash is nice so we'll be very judicious capital allocation is very important to us.
Eben Tessari: But Eben, anything that you want to add? No, I think you said it really nicely, Sanj. You know, it's really about maximizing value for patients, and we're always looking. Thank you. Our next question comes from the line of Liisa Bayko with Evercore ISI. Your line is open. Hi there. Most of my questions have been answered, but just one: maybe you can talk about the shape of R&D for this year. Just looking historically, it seems to bounce around a little bit.
But obviously, having values that realistic as well are important too, but ebb and anything that you want to add.
No I mean, you've got a really nice eastbound it's really about.
Maximizing value to patients.
And we're always looking.
Thank you. Our next question comes from the line of Lisa <unk> with Evercore ISI. Your line is open.
Hi, there most of my questions have been answered, but just one maybe you can talk about the shape of R&D for this year I'm just looking historically it seems to bounce around a little bit how should we be thinking about the shape of your R&D spend for this year. Thank you.
Liisa Bayko: How should we be thinking about the shape of your R&D specifics? I'll give Mark, I don't have a bit of muscle memory, so go ahead Mark, jump in. Emily, I don't think, you know, there's much to comment on regarding where we're allocating our resources right now beyond what we've disclosed publicly. So, really, obviously, the commercialization of Arcalis, but on the R&D front, the progression of the clinical trials of VIXA and PN and 404 and RA.
Okay, Mark hasn't had the muscle memory Scott go ahead, Marc jump in.
I believe so and I don't I don't think.
There is much to comment on regarding where we're allocating our resources right now beyond what we've disclosed publicly so really the pause.
The commercialization of <unk> on the R&D front.
Progression of the clinical trials of VIX in Pn and four 4%.
Liisa Bayko: And really, you know, the timing of clinical trials is key here for R&D. So, you know, as I mentioned, VIXA is sort of in the final stages of Phase IIb. We're expecting it in the second half of this year, and we just initiated the RA trial at the end of 2021.
And really the timing.
Michael trials is key here to R&D so.
As I mentioned.
And sort of in the final stages of the phase two b were expected in the second half of this year and we just initiated the RA trial.
Sort of at the at the end of 2021.
Thanks.
Mark Ragosa: Thank you. I'm showing no further questions at this time. I would now like to turn the conference back to Sanj Patel, Chief Executive Officer.
Thank you I'm showing no further questions at this time I would now like to turn the conference back to <unk> Patel, Chief Executive Officer.
Sanj Patel: Thanks very much, Apoet. Noah, thank you for all the questions and, obviously, for everybody joining our call today. I hope you got a sense of the excitement that we've all got and we definitely look forward to providing additional updates as we move into the rest of the year. I think Ross said it very eloquently and appropriately, we've had a cracking commercial execution start, and we certainly intend to keep that going.
Thanks, very much operator, no. Thank you for all the questions and obviously if everybody joining our call today I Hope you got a sense of the excitement that we've all got and we definitely look forward to providing additional updates as we move into the rest of the year I think Ralph said, it very eloquently and appropriately with had a cracking commercial execution stock and we certainly intend to keep that going so.
Sanj Patel: So let's crack on. This concludes today's conference call. Thank you for participating. You may now disconnect. [music]
Let's krakoff. Thank you everybody.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
[music].
Okay.
[music].
Okay.
Okay.
Okay.
[music].
Okay.
Okay.
<unk>.
[music].
Thank you.