Q3 2025 Kiniksa Pharmaceuticals Ltd Earnings Call
Speaker #2: Thank you for standing by and welcome to the Kenexa Pharmaceuticals . Third quarter 2020 Earnings Conference Call . At this time , all participants are listen only mode .
Speaker #2: After the speakers presentation , there will be a question and answer session . To ask a question during this session , you will need to press star one on your telephone .
Speaker #2: If your question has been answered and you'd like to remove yourself from the queue , simply press star one one again . As a reminder , today's program is being recorded .
Speaker #2: And now I'd like to introduce your host for today's program , Jonathan Kirshenbaum Investor Relations Officer . Please go ahead , sir .
Speaker #3: Thank you . Operator . Good morning , everyone , and thank you for joining . Call to discuss our third quarter 2020 financial results and recent portfolio execution .
Speaker #3: A press release highlighting these results can be found on our website under the investors section . As for the agenda for today's call , our Chief Executive Officer , Sanjay Patel , will start with an introduction and overview of our business .
Speaker #3: From their Ross Moat , our chief corporate and Commercial Officer will discuss our IL one inhibition franchise and provide an update on our commercial execution .
Speaker #3: Then Kiniksa Chief Financial Officer , Mark Ragosa will review our third quarter 2020 financial results . And finally , Sanjay will share a closing remarks and kick off the Q&A session for which Doctor John , our Chief Medical officer , and Evan Tessari , our chief Operating officer , will also be on the line .
Speaker #3: 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 .
Speaker #3: 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 .
Speaker #3: 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 .
Speaker #3: With that , I'll turn it over to salvage .
Speaker #4: Thanks , Jonathan , and good morning , everyone . Year to date in 2025 , we've continued to execute and meaningfully advance our commercial business and clinical development portfolio .
Speaker #4: The use of our one alpha and beta inhibition with Arcalyst has increasingly become the preferred treatment for recurrent pericarditis, driving significant Arcalyst revenue growth and positioning.
Speaker #4: Our franchise for long term success , both with arcalyst and KPL 387 . We continue to be excited about the potential of our IL one inhibition franchise , and fully intend to remain the market leader in recurrent pericarditis , given the fact that , as last reported , we were only 15% penetrated into the multiple recurrence patient population .
Speaker #4: We expect to continue to grow Arcalyst revenue to this point . As announced this morning . We've raised our full year net sales guidance to between 670 to $675 million from our previous guidance of 625 and $640 million .
Speaker #4: We also believe KPL 387 could be an important advancement in the treatment of options available for patients , potentially increasing penetration and growing the recurrent pericarditis market .
Speaker #4: We remain on track to report data from the phase two dose focusing portion of the phase two . Phase three trial . In the second half of next year .
Speaker #4: Additionally , we are pleased to report that early this month , the FDA granted KPL 387 Orphan Drug designation for the treatment of pericarditis , which includes recurrent pericarditis .
Speaker #4: Importantly , we have maintained a robust financial position while continuing to create value without relying on the capital markets . Turning to the growing adoption of Il1 alpha and beta inhibition with Arcalyst , we've introduced and advanced a fundamental shift in the treatment paradigm for this disease .
Speaker #4: Roche will share more details about this in a moment . In the third quarter , Arcalyst revenue grew to $180.9 million , which represents a growth of approximately $24 million over the previous quarter .
Speaker #4: And approximately $69 million compared to the third quarter of 2020 . For while we're pleased with this growth , we continue to believe in these significant opportunity for additional growth ahead .
Speaker #4: As of the end of the second quarter , we were only 15% penetrated into the multiple recurrence opportunity , and we continue to see Arcalyst utilized earlier in the course of the disease .
Speaker #4: As previously stated , approximately 20% of Arcalyst prescriptions have been written for patients following their first recurrence . For patients who failed NSAIDs or colchicine , physicians are more readily turning to targeted IL one alpha and beta inhibition with arcalyst rather than risk an unnecessary flare by treating patients again with a previously unsuccessful treatment .
Speaker #4: Overall , the progress we've made reflects the medical community's growing adoption of IL one pathway inhibition and speaks to the future value creation of our IL one inhibition franchise .
Speaker #4: With that , I'll turn it over to Roz . Thank you Sarge . The growing understanding of recurrent pericarditis being driven by the cytokines interleukin one , alpha and beta has been a key driver behind the growth .
Speaker #4: We've seen in the adoption of Arcalyst as an increase in number of healthcare professionals . Update their approach in how to treat recurrent pericarditis with targeted IL one immunomodulation .
Speaker #4: We've seen a substantial increase in the number of active commercial patients on Arcalyst . Specifically , this is a result of our team driving increases in two key areas .
Speaker #4: Firstly , in Q3 new patient enrollments grew by their highest level in a quarter since launch . This is represented in the growth of prescribers of more than 350 .
Speaker #4: In the quarter, leading to a total prescriber count launched to date of more than 3,825, including around 28% or more than 1,000 prescribers who have written Arcalyst for two or more patients.
Speaker #4: Secondly , once on treatment , patients are staying on Arcalyst for longer , which speaks to both the duration of the disease and patient satisfaction on arcalyst .
Speaker #4: At the end of Q3 , the total average duration of therapy increased to approximately 32 months . These two levers increased the number of active commercial patients and contributed to our ability to raise our revenue guidance for the full year 2025 .
Speaker #4: Our commercial organization has been highly focused on evolving the treatment landscape for patients suffering from this chronic , highly debilitating disease . By increasing education and driving the utilization of interleukin one , alpha and beta inhibition towards becoming the new standard of care for recurrent pericarditis .
Speaker #4: We have built a highly effective commercial infrastructure and built upon many years of established relationships with the recurrent pericarditis community to improve the care for patients in the four and a half years since the launch of Arcalyst .
Speaker #4: We've continued to hone our messaging and we've improved our effectiveness through utilization of AI and digital marketing to inform which physicians to visit and importantly , when they're most likely to see a recurrent pericarditis patient .
Speaker #4: Thanks to the compelling clinical and real world data generated in Rhapsody and Resonance , our payer approval rate remains very high and we continue to be focused on excellent support to patients through Cxcr1 connect , our patient services program .
Speaker #4: This combination of robust data delivering access and support enables healthcare professionals to feel confident that their patients will get on therapy , be well supported and receive the type of efficacy we've seen in the published literature .
Speaker #4: As a result of the continued growth in patients on Arcalyst today , we raised and tightened our full year 2025 Arcalyst net sales guidance .
Speaker #4: From between 600 and 20 5 to $640 million to now , between 670,000,006 hundred and 75 million , which is a $40 million increase in guidance between the midpoints .
Speaker #4: Our increased guidance reflects the robust trajectory of Arcalyst revenue in 2025 , while also accounting for typical year end industry dynamics , which is consistent with our historical fourth quarter performance .
Speaker #4: As you've heard , we're pleased with our solid execution and progress and are incredibly excited about the opportunities we have ahead . As we continue to focus on maximizing the growth of Arcalyst .
Speaker #4: We are also excited about the opportunity to advance the care of recurrent pericarditis patients in the future . With KPL 387 , our development program .
Speaker #4: This is our fully owned monoclonal antibody antagonist targeting the IL one receptor to inhibit both IL one alpha and beta . The totality of data show that inhibiting the activity of both of these key cytokines is a core component of delivering a highly efficacious treatment for recurrent pericarditis .
Speaker #4: With this program , we're advancing a validated mechanism with the potential to address key patient needs and expand penetration into the addressable market by enabling a convenient monthly subcutaneous dose in an autoinjector .
Speaker #4: Survey patients and healthcare professionals have indicated a preference for a highly efficacious IL one alpha and beta inhibitor . With this target profile specifically , approximately 75% of all surveyed recurrent pericarditis patients reported that they would prefer the CPL 387 target profile over those of available commercial and current investigational therapies on the physician side .
Speaker #4: More than 90% of healthcare professionals stated a high likelihood of prescribing CPL 387 for new patients , as well as being receptive to switching current patients upon a patient's request .
Speaker #4: It's also worth noting that healthcare professionals broadly agree that the introduction of CPL 387 would expand the IL one alpha and beta inhibition market overall .
Speaker #4: As we previously announced , the dose focusing portion of the phase two three development program of CPL 387 is currently underway , and we expect those data in the second half of 2026 .
Speaker #4: With that , I'll turn the call over to Mark Ragosa to review our third quarter financials . Marc . Thanks .
Speaker #3: Ross .
Speaker #5: This morning I will cover our third quarter 2020 financial performance . Our detailed results can be found in the press release we issued earlier today .
Speaker #5: There are several items on the slide that I'd like to call your attention to . Starting with our income statement on the left hand side .
Speaker #5: First , our revenue grew 61% year over year . In the third quarter to 180.9 million , with adoption of IL one Alpha and IL one beta inhibition for recurrent pericarditis .
Speaker #5: Continuing to drive significant gains in active commercial patients and duration of therapy . Second , operating expenses grew 29% year over year in the third quarter to 156.8 million , primarily due to collaboration expenses , which were driven by continued strong arcalyst collaboration .
Speaker #5: Profit growth was strong in Q3 2025, due to strong revenue growth against more moderate operating expense growth. Net income was $18.4 million in the third quarter of 2025, compared to a net loss of $12.7 million a year ago.
Speaker #5: Next , the right hand side of this slide provides the calculation of Arcalyst collaboration profit , which drives collaboration expenses . Arcalyst collaboration profit grew a significant 118% year over year to 126.6 million in the third quarter .
Speaker #5: As profit split eligible Cogs , as well as commercial and marketing costs held steady against higher sales . Lastly , at the bottom of this slide , we continue to expect our current operating plan to remain cash flow positive on an annual basis .
Speaker #5: And in the third quarter , our cash balance increased by approximately 44 million to 352.1 million . As you've heard from Sanjay and Ross and we further advanced our commercial business in clinical portfolio as well as maintained a strong balance sheet in the third quarter .
Speaker #5: As a result , Kiniksa added to its significant momentum and remains well positioned to continue to help patients as well as to create additional value in both the near and long term .
Speaker #5: With that , I'll turn the call back to Sandy for closing remarks .
Speaker #4: Thanks , Mark . As you've heard , clinics continues to execute both commercially and clinically , and we are well positioned to build significant future value as we grow our il1 alpha and beta inhibition franchise .
Speaker #4: As ever , we are committed to bringing additional treatment options to patients that are suffering from debilitating diseases with unmet need . I'll now turn the call back to the operator for questions .
Speaker #4: Thank you . .
Speaker #2: Certainly . And our first question comes from the line of Geoff Meacham from Citi . Your question , please .
Speaker #6: Good morning . This is Mary Kate on for Jeff . Thank you so much for taking our question . So you're seeing duration increase here for Arcalyst , which is encouraging .
Speaker #6: Could you comment on maybe the patient and physician feedback you're hearing from these longer users? Thank you.
Speaker #4: John , do you want to take that ? Sure .
Speaker #5: So in general , what we're seeing , certainly in terms of the academic literature , is an appreciation of the duration of disease .
Speaker #5: And and therefore the necessity of treating to that duration of the disease in order to minimize the amount of recurrences that patients experience .
Speaker #5: So what we know from the literature is that the median duration of disease is three years , with a third of patients still suffering disease at five years and a quarter at eight years .
Speaker #5: And so the other data that we have , in fact , which we recently showed at the European Society of Cardiology meetings , is that continued treatment without interruption , resulted in a 99.5% reduction in event rates .
Speaker #5: Post-treatment or on treatment compared to pre-treatment . So that creates a very powerful message , if you will , for clinicians that you know , treating to the duration of the disease is the best way to manage the disease .
Speaker #4: Thanks , John . And maybe just to add , on top of that as well , in terms of the healthcare professional , patient feedback that we're getting , generally we receive very positive feedback for those patients that have been on on therapy for quite some time and are growing amount of time up to now , 32 months .
Speaker #4: So there's an average total duration of therapy . What we see on the healthcare professional side is generally due to the high access rates that we get , the healthcare professionals see their patients get onto therapy .
Speaker #4: Reasonably quickly and easily . Thanks to that higher approval rate . So that kind of provides confidence that their patients are going to get onto therapy and helps them to then look for future patients knowing that their patients will get onto therapy .
Speaker #4: And then for the patients themselves , the fact that they've been on therapy for longer , I think is also part of the evidence of doing well on therapy .
Speaker #4: You know , we continue to hear very high satisfaction from patients on therapy . And I think that backs up what we've seen both in the clinical world and the real world .
Speaker #4: Evidence of how highly efficacious and well tolerated this drug is . And as a reminder , it's been designed to be used over the course of the treatment .
Speaker #4: The duration of the of the disease and to match that duration of the disease with the treatment duration . So this has really been designed as a long term therapy to address what is a chronic , multi-year and highly debilitating disease for most patients .
Speaker #4: So the feedback has really been very good for both healthcare professionals and patients overall.
Speaker #2: Thank you. Our next question comes from the line of Anupam Rama from J.P. Morgan. Your question, please.
Speaker #7: Hey guys . Thanks so much for taking the question . And congrats on the quarter . Can you talk a little bit how you guys have sort of incorporated the updated ACC guidelines into your sort of marketing efforts and what the early innings , what you've learned from the guideline update , because I think that was just a couple of months ago , right .
Speaker #7: In August of this year . Thanks so much .
Speaker #5: Hi . Thanks for the question . I'll start off with a brief summary of the concise clinical guidance and then hand it over to Ross .
Speaker #5: Regarding your question about incorporation of the guidance into into the field work . So specifically to the concise clinical guidance . Yeah , this is really this came out in August and represents an affirmation of what we've seen from the literature .
Speaker #5: And actually driven by the data that we've helped to generate , which is positioning IL one pathway inhibition as second line after NSAIDs and colchicine , which is a real advance in the in the treatment paradigm to be truly steroid sparing .
Speaker #5: And so that was driven by the initial data from from the Rhapsody program , where half the patients were treated . You know , second line after NSAIDs and colchicine .
Speaker #5: And then that was then picked up from our residence registry showing year on year after the approval of Arcalyst . You know , a reduction in the use of corticosteroids and a rise in IL one pathway inhibition led by by arcalyst , you know , in the treatment of these patients .
Speaker #5: And so that was then picked up by advances . In Jak imaging in the thought leader leadership literature . But then ultimately it culminated , if you will , in the concise clinical guidance , which is a real affirmation from a , you know , practice entity to provide guidance to clinicians so Jack that creates that strong foundation that Ross and his team have been building on .
Speaker #5: So , Ross , over to you .
Speaker #4: Yeah . Thank you John . So I think it was really much needed guidance that we were pleased to see , given that this is really the first US focused guidance publication that's really out there , we're utilizing it certainly within a promotional perspective .
Speaker #4: And incorporated it within promotional materials . And as John said , it's really an affirmation of the type of messaging that we've really been providing since launch .
Speaker #4: So it's wonderful to have , you know , further publications from experts in the field affirming the type of approach and new approach to to managing this disease compared to historic , you know , available drugs .
Speaker #4: And in particular around the utilization of corticosteroids , which we've always promoted arcalyst as a really a steroid sparing agent and a drug which should be utilized ahead of corticosteroids .
Speaker #4: And having this type of publication out there , as I say , which we have incorporated within our materials now as well , from a promotional perspective , is a huge a huge help knowing that the use of corticosteroids is probably not the , you know , the most advanced way of treating this condition .
Speaker #4: Now that there is a targeted immunomodulation approach , specifically looking at the key driver of this disease , which is interleukin one , alpha and beta , and being able to inhibit that , we really see as the the modern way of treating this disease .
Speaker #4: And we hope will become the new standard of care .
Speaker #7: Thanks so much for taking our question .
Speaker #2: Thank you . And our next question comes from the line of Roger song from Jefferies . Your question please .
Speaker #8: Great . Congrats for the quarter and thank you for taking our question . My question is related to the first recurrence since your revenue is driving very well , penetration continue to be very good and then how should we think about the first recurrence if that's the population , you will start to think more about it .
Speaker #8: And then what could drive further penetration into that population . Thank you .
Speaker #4: Yeah . Thanks , Roger . This is Ross again . Yes . As you noted , we have seen an increase over time in how physicians are utilizing arcalyst within the first recurrence of recurrent pericarditis .
Speaker #4: And as a reminder, that really is the breadth of the label. The label is completely agnostic to the number of flares a patient must have gone through.
Speaker #4: And suffered from before they become eligible for this targeted immunomodulation therapy . So we have promoted it to recurrent pericarditis overall , but certainly early on in the launch , we did see the physicians were utilizing it more within the two plus recurrence group , which is a 14,000 patient population in any given year .
Speaker #4: We've seen a lot of utilization . There , but I think as physicians become more and more comfortable and familiar with how to prescribe the drug , and then going back to the first question , the physicians and patients have a good experience when they're on the drug .
Speaker #4: And they get access to therapy and see the type of results that we've seen in the clinical world that provides greater confidence of using it .
Speaker #4: Earlier on in the disease . And I think what we're seeing is physicians taking a mindset of why , why should we let patients continue to suffer from additional flares before they become eligible for for this targeted treatment ?
Speaker #4: So we have seen now around 80% of our patients that have prescribed arcalyst within the two plus recurrence group and around 20% of all of those that are prescribed arcalyst are within the first recurrence group .
Speaker #4: And obviously, that has grown in percentage terms over time. But as we said in the prepared remarks, we are incredibly excited about the future opportunity.
Speaker #4: Knowing that we announced midway through this year that we were around 15% penetrated into the two plus recurrence group without even taking into account those patients in the first recurrence .
Speaker #4: So the opportunity ahead to serve many , many more patients , while we're happy with our current commercialization , the future is is certainly there for us to address and help many more patients in the future .
Speaker #4: Excellent .
Speaker #8: Thank you .
Speaker #2: Thank you. And our next question comes from the line of Eva, from Wells Fargo. Your question, please.
Speaker #9: Good morning . Thanks for taking our questions and congrats on the quarter . Two from us . First on Arcalyst . Can you discuss the gross dynamics for the quarter ?
Speaker #9: And second , on KPL 387 ? What are the what will be the drivers of your decision on the phase three dose ? Given that if I recall correctly , the phase two is empowered to demonstrate a statistical difference ?
Speaker #9: Thanks .
Speaker #5: Thanks . I guess first on the on the gross to net , you know , for the quarter year to date it was 8.9% , down from 9.5% year to date .
Speaker #5: In the second quarter . So lower and in line with our historical pattern where we see it highest in the first quarter due to industry dynamics such as benefit plan resets and copay support , and then lower in the second and third quarter , and then moving slightly higher in the fourth quarter .
Speaker #5: As industry dynamics begin to play a factor again . And Eva , thanks for the question about KPL 387 dosing . So importantly , the phase two portion of the study is a dose focusing type study rather than a formal dose ranging type study .
Speaker #5: And that is because our modeling has shown that the 300 mg subcutaneous dose, which in healthy volunteers lasts for almost two months, should provide sufficient coverage for monthly dosing.
Speaker #5: And so, therefore, the Phase 2 study is designed really anchored on that 300 mg subcutaneous dose given every month, and then looking to see the 300 mg given every other week.
Speaker #5: So it does not provide additional efficacy . And that lower doses exhibit weakness , which would then all affirm the use of the 300mg subcutaneous dose level .
Speaker #5: And so that's how we will look at that information and move forward into phase three . Thank you for your question .
Speaker #9: Got Thanks .
Speaker #2: Thank you . And our next question comes from the line of Nick Larissa from TD Cowan . Your question please .
Speaker #5: Thanks very .
Speaker #7: Much for taking the question . And congrats on a great quarter . Can you discuss what drove the strong increase in the number of prescribers this quarter compared to last quarter , and what the plan is to continue this uptake ?
Speaker #7: .
Speaker #4: Sorry , Nick , can you just repeat the last part of the last question ?
Speaker #7: Yeah . What proportion of recurrent pericarditis patients do the 3800 prescribers see ?
Speaker #4: Okay , so thanks very much . Let me answer the question and please come back . If he doesn't answer it fully . Yeah .
Speaker #4: So we've we've seen that there's been a significant increase in the number of prescribers . This is actually in Q3 , the highest increase that we've seen in any quarter launched to date .
Speaker #4: And that's more than 350 new prescribers coming in who have never prescribed Arcalyst before prescribing it for recurrent pericarditis. And that takes the total to more than 3,825.
Speaker #4: And about 28% of those are repeat of that total group of written for two or more patients . I think the things that lead into that is just more more confidence , more awareness of arcalyst as a treatment choice .
Speaker #4: I'm sure the ACC guidance has also been somewhat help . Towards that . Just providing more validation , if you like , of the of a way of how to treat this disease .
Speaker #4: But our team have been , you know , very targeted in their approach . Both our sales team in the in the field calling upon healthcare professionals .
Speaker #4: We've done a lot of work to really try to understand where the patients are presented into . And as a reminder , this is a disease space where it's actually the patient population is pretty widely dispersed .
Speaker #4: So there's the opportunity to go into too many physicians . There's the opportunity for recurrent pericarditis patients to go into many physicians . So I think we're getting better at both honing our messaging as well as understanding the patient throughput .
Speaker #4: And not only which physicians these patients are going into, but also using, you know, more innovative technology to play through when we believe those patients are going to be visiting healthcare professionals.
Speaker #4: So we use that a lot of kind of AI and digital innovation approaches to guide our field team . On the other side of that , we're also very focused on digital marketing and making sure that our messaging around arcalyst and recurrent pericarditis goes far and wide across the population outside of our in-person resources .
Speaker #4: So there's a lot of tactics that we have to try to try to drive that . I mean , we've seen some substantial growth , and that's certainly a big part of the Q3 results that we've seen .
Generally a very easy and quick process for them to do so. Generally, there's a pay approval already in place and it's quite easy to get the next shipment of of Arc list. Ready, and we know that when patients go back onto therapy after suffering symptomology again, um, they come back under control very quickly with, with Arc list. So that's what we've seen around the initial and the restarts. And obviously, that's the totality of adding up the treatment periods, which for some patients is is several stops and restarts over time. Um, that's what
Makes us to the average total duration of therapy, now, of of 32, months up from 30 months. Um, at last reported
Uh, Switzerland and the U.S., net of, uh, City R&D and stock-based, uh, comp credits.
And Paul. This is John. Thanks for your question. Um, about uh, you know, the competitive landscape. Um, so yes, we're at the field as a waiting, uh, data from, you know, an inflammation inhibitor, uh, you know, Phase 2 data and so in that sense, uh, not so much wrap City, but rather those data are structured in some ways similar to The Phase 2 data that we had reported for rwa back in 2019. You know, at the beginning of the program, which is relatively short-term therapy uh, and and mostly, you know, single active arm. Um, and so, in that sense, yeah, you would expect with, uh, near-term, you know, uh, short-term therapy, especially if you have an employment Zone inhibitor, and an inflamm zone is, of course, um, you know, the the driver of 1 beta, which then causes, I know, 6 production, which goes to the liver, which is where the C reactive protein comes from you might expect to see a, you know, a good inflam inhibitor, you know, just like culture scene, you know, should bring, um, you know, C reactive protein down. But the point is that, you know, the in
flamos is relatively Downstream in the pathophysiology of recurrent pericarditis. So as you know, um, you know, when the pericardio site is injured, I owe 1 Alpha is released as a pre-formed Saito, is an alarming. And that sets off a localized inflammatory response which itself causes, you know, pain and damage. Um, it does then trigger.
The inflammatory Zone, which then causes the recruitment of that, you know, broader inflammatory response. But, you know, that's why, you know, we're really focused on blocking both il1 Alpha and il1 beta, um, in order to control the disease. And that's what we showed in, wraps City in a longer, you know, phase 3 program where, you know, you have continued treatment, you know, initially over 9 months, but ultimately over 18 months and then ultimately, out to 3 years, where we shared a 99.5% reduction in events once patients were on treatment, uh, and that the, you know, the only events that occurred were during the setting of, you know, brief study drug interruptions. And so, in that sense, you know, a drug like arculus is designed, you know, to be given long term uh, and it remains to be, you know, to control the disease and it remains to be seen whether others, you know, strategies could be, um, you know, could be successful. But that kind of sets the bar uh, if you will, for what, um, you know, effective therapy looks like,
Great, thanks for taking our questions.
Thank you. And our next question comes from the line of David nearing, Garten from wedbush Securities your question, please.
Hey, thanks for taking the question. I had 1 on the, um, transition arm of the, um, 387 study. And I was just wondering if you were biasing, um, the study to different, um, prior therapies. So, you know, are half the patients going to be, um, you know, previously treated with steroids or
Yeah. Just or is it just an even, um, split among prior therapies. Thanks
Uh, thanks. David know, appreciate the question. So your question is about the transition to monotherapy dosing and administration study, which is a supplemental study as a, as part of the total, uh, filing package. Yes. So, this study is designed to help inform clinicians how to move patients onto kpl 387, you know, from other prior therapies. And so that includes, uh, really the totality of therapies that are available. So NSS and culture scene corticosteroids and other Ireland pathway Inhibitors and it's a global study. So it covers, you know, those practice patterns across, you know, across the world. And so you know how the study is uh, is designed is to capture that, uh, information and to test the efficacy and safety of those dosing paradigms that are used, uh, in order to make that transition to kpl 387 monotherapy and is designed to capture the necessary information, you know, for each 1 of those types of transitions uh you know, in order to provide, you know, critical information if you will for the label to
Address clinicians. Uh but there is not necessarily in nor does, there need to be any type of prespecified hypothesis or specific population balance, other than giving the necessary information, you know, to inform, you know, regulatory authorities positions on how that works.
Okay, thanks.
Thanks.
Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Sanj Patel, Chairman and Chief Executive Officer, for any further remarks.
Thanks operator. Thanks everybody for joining the call today and for the questions, of course, uh, we look forward to the remainder of the year and providing additional updates in the future. And in the meantime we will crack on. So thank you.
Conference, this does conclude the program. You may now disconnect. Good day.