Kiniksa Pharmaceuticals International, plc (KNSA)
NASDAQ: KNSA · Real-Time Price · USD
53.85
+10.24 (23.48%)
At close: Apr 28, 2026, 4:00 PM EDT
54.00
+0.15 (0.28%)
After-hours: Apr 28, 2026, 7:59 PM EDT
← View all transcripts

Goldman Sachs 45th Annual Global Healthcare Conference

Jun 11, 2024

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. We'll continue with the next session. I'm Paul Choi, and I cover the SMID-Cap biotech sector here at the firm, and it's my pleasure to welcome Kiniksa to this session. To my immediate left is CEO Sanj Patel. To his left, Ross Moat, commercial. And then we have John Paolini, at the end, CMO. What we'll do is, let's maybe Sanj kick it off with some opening statements, and then, we'll go into Q&A.

Sanj Patel
CEO and Chairman, Kiniksa

Thank you, Paul. Happy to be here. Thanks for hosting us this morning. Delighted to be here with the team, as you mentioned. First of all, please note we will be making forward-looking statements today that are subject to risks and uncertainties. Review of those statements, risk factors found in our SEC filings. So happy to kick it off. Happy to open with any opening remarks at all, or if you just want to jump right in.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Sure. So maybe, starting with ARCALYST here, if we could. Commercial performance has been very steady and nice growth continuously and consistently since the launch. Can you maybe, I don't know, Sanj or Ross, up to you, talk a little bit about, you know, what the evolution in patient behavior has been like since the launch and, you know, maybe what you can comment on with regard to the mix of repeat prescribers versus first-time prescribers? Maybe start there.

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. Yeah. Maybe, Ross, I'll start with, well, a higher sort of level overview of how the launch has gone, and then happy to get into that. So first of all, as you mentioned, you know, ARCALYST has now been approved for just over three years. It's been since the launch. It's been a phenomenal launch to date, and we're very pleased with it. In fact, just recently, in Q1, we reported revenues of $78.9 million. And in fact, based on that, we have just recently amended our guidance now for a full-year 2024 revenue of $370 to 390 million. You know, as a reminder, it is the first and only FDA-approved therapy for recurrent pericarditis, and we're very pleased with the launch to date. You know, obviously, it's a lot of work ahead of us, and we plan to continue that growth.

I'm sure today we'll get into some of the key levers for ensuring that growth, continuing that phenomenal revenue trajectory.

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Absolutely. Right. Maybe I can add to that and say, you know, we're pleased to how things are going so far. But more excited about the opportunity that we have ahead. We announced at the end of last year we were around 9% penetration into the 14,000-patient target population that we're very focused on, which tells you that we're making good progress, but it also tells you we've got a very significant opportunity ahead of us. Regarding patient behavior, the type of patients we have on, I guess what I can say is that we're, we're pleased with the feedback that we get from patients. They come back with feedback that they're highly satisfied with ARCALYST as a treatment, and it's really addressing the root cause of the disease.

We have a lot of touchpoints with the patients that we look after with ARCALYST through Kiniksa One Connect, our patient service program and all the different programs that we have under that umbrella. So we hear from patients anecdotally that really the clinical data, which was so compelling coming out of RHAPSODY as the phase III pivotal study, is really being lived out in the real world. Patients are, I think, appreciating the drug, and it's really helping them through the disease. And we see that the payers also appreciate the value proposition we have. We have a very high payer approval rate, and that's enabling patients to get onto therapy. So to your point around repeat prescribers, we see the prescriber base increase substantially quarter-over-quarter ever since launch.

At the end of Q1, we announced that we have more than 2,000 unique individual prescribers of ARCALYST for recurrent pericarditis. And of that group of, just over 2,000, physicians, around 24% of those, physicians have become repeat prescribers, so they've prescribed for two or more, recurrent pericarditis patients with, with ARCALYST. And then importantly, in Q1, around 40% of all the new prescribing that happened within that quarter came from that 24% group of repeat prescribers. So we're seeing that grow nicely as well. But as, as Sanj kind of alluded to, we're pleased to how things are going. But we're never complacent, and we're always stretching for more.

We've got a lot more work to do to increase the penetration into the opportunity, as well as constantly look at all the other different areas of the model and how we can support patients by looking at duration, compliance, adherence, and all the other levers that go into the business.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Great. Just speaking of penetration, I think, most recently you indicated you're sort of like mid- to- high single-digit type market penetration, give or take, at this stage. I guess maybe both in terms of physician awareness and patient awareness, I guess, you know, what, you know, do you think about in terms of your commercial strategy to build brand awareness and sort of grow that, you know, mid-high single-digit penetration, given what looks like a pretty long runway ahead in terms of at least in terms of the patient population?

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. I mean, most recently we've disclosed that we're around 9% penetration into the market, as you said, Ross, into that 14,000 patients that have two or more recurrences. Certainly we've done a lot of things since the launch. You know, obviously we expanded initially from around 29 reps to 50, and now from 50 to about 85. And that's gone a long way to helping both physician and patient awareness. And there are a number of other things. Obviously, we have a very strong medical affairs team with MSLs. They're also talking a lot about the RHAPSODY data as well as the long-term extension data that we've had available. So that continues to grow. It's really all about education, awareness. You know, we do have things like Kiniksa One Connect, which is helping patients throughout their journey, and so that's been part of the parcel.

But again, as Ross said, we're not getting complacent. We do believe that 9%, obviously, on the one hand, is great. On the other hand, it tells you there's an awful lot more opportunity for us to really penetrate into that market, and that's exactly what we're doing.

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Yeah. Exactly right. So we've grown the field team, since the time of launch. We're up to around 85 representatives that we started this year. That's enabling us to go broader, into the opportunity. So the number of patients that we can reach, we are targeting, and we've got a very laser-focused targeting strategy around 11,000 healthcare professionals across the US, with our around 85 field team. We also obviously have the MSL team, a payer team, as well. We're also very focused on digital marketing, trying to find very efficient ways of getting out there, spreading the awareness, and trying to move general awareness of recurrent pericarditis and ARCALYST through to actually being very knowledgeable about the disease, about the drug, how to prescribe it, what the clinical trial data look like.

So we're really focused on the execution and being excellent in what we do, as a commercial field team and across the other teams that we have as well. It's not just about growing the number of people that we have out in the teams, which we've done in the past, but it's about being really excellent and very targeted at everything that we do. And that's what's switching on more and more prescribers and helping us to reach more and more patients.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. I want to actually ask a question we get from investors a lot, which is like kind of what, what where duration could maybe sort of ultimately end up on, on a real-world basis.

I think people are constantly surprised that it keeps ticking up as you build up the patient experience in the real world, even compared to what was, you know, very strong adherence and compliance in the clinical trial setting. So maybe just in terms of driving the sales growth and just sort of the stickiness of patients, you know, has there been any change in patient behavior in that respect? And just kind of like where do you think this therapy, I guess, could become? Because I think there's a view that maybe this is, you know, sort of like an acute treatment, but at least the patient behavior to date and the growing numbers suggest this is more of a maintenance treatment. So what does that potentially mean to, I guess, for your commercial potential?

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Yeah. Ultimately, this is a chronic flaring disease. I think, as you said, we've seen the duration tick up. I think initially at launch we were thinking that the duration may be around six to nine months, and that's now obviously most recently we said around 23 months. Where it goes from here, obviously time will tell, but the education certainly helps. The data we've had so far helps. You know, the compliance has been very strong, above 85%, you know, to date. So it, it remains to be seen, but it certainly is a chronic flaring disease, and there is the opportunity, we believe, of a longer duration, but time will tell.

Yeah. And again, it's about being excellent in our execution of the messaging, and we're very clearly messaging around the disease and trying to educate physicians that the treatment paradigm that they previously used for recurrent pericarditis, which was short-term treatments and, you know, without the availability of an approved therapy to treat the root cause of the disease. And when people would use corticosteroids, for example, you try and use it for as short a time period as possible. Well, we're really changing the paradigm for the treatment. So we're educating physicians around the natural history of the disease, which is that for recurrent pericarditis for patients that have two or more recurrences, they suffer from the disease in the median of three years, and around a third of those patients still suffer from the disease at five years out.

So as Sanj said, this is a chronic disease that needs to be treated throughout the course of the disease. I think we're making good progress in educating around that and changing the behavior of how the disease is treated, which is why you've seen the duration grow from six to nine months at launch and our expectations at launch through most recently to around 23 months in total on average. And we'll see how that changes over time, and if indeed it does. It's something we'll continue to monitor and share what we see. But we really want to educate around the disease and how long the disease lasts. And this is a chronic disease. The patients need to be treated throughout the course of it.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Great. In terms of how patients come onto a drug, do you see much experience in terms of patients when they have a recurrence coming into, let's say, the ER or something like that? Is it used sort of in an acute setting, or is this more of a therapy that comes on in terms of like having a conversation in the physician's office after they're out of the ER after a hospital visit, whatever the case may be? And, you know, just how do you think about this maybe being in an acute setting for patients who have an acute recurrence?

Sanj Patel
CEO and Chairman, Kiniksa

Maybe I'll start with some clinical trial data and then pass it on to.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Sure.

Sanj Patel
CEO and Chairman, Kiniksa

Ross, for the real-world experience. So, you know, the data from RHAPSODY really support an indication statement of both the treatment of recurrent pericarditis as well as in the reduction of risk of recurrence. So both as a treatment to reduce the flare, as well as, as you mentioned, as a maintenance therapy to, you know, prevent recurrence. And so, you know, we know for a fact that from the clinical trials data and patients that were actively flaring, you know, time to treatment response is five days. On the other hand, you know, what we know is that if you treat patients, you know, over the long course, continued treatment resulted in continued treatment response.

And so that really, you know, hammers home the message of, as Ross was saying, that maintaining treatment throughout the duration of the disease is the way to get that persistent clinical response, in terms of how patients are entering in the real world in terms of flare versus non-flare.

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Yeah. Thank you. So we, we actually, out of all the patients that come into ARCALYST, we have around 80% of the patients that come to us, that are actively in a flare at the time that ARCALYST is prescribed and around 20% who are not in a flare. So I think that speaks to how broad our label is in recurrent pericarditis, where it's for the both the treatment and the prevention, of, of recurrent pericarditis and, and subsequent episodes and the reduction of, of risk of further episodes. So we see that, you know, utility, across the, the spectrum of patients suffering from the disease. In terms of the often when patients are on their, index episode, they, they go into and usually, you know, myocardial infarction is ruled out.

And then sometimes patients go on a bit of a diagnostic odyssey of different diagnosis before recurrent pericarditis or pericarditis is diagnosed. So we're trying to work pretty intensively on the education for the accurate and timely diagnosis of recurrent pericarditis. And then over time, as patients understand more about the disease, when they suffer from further flares, often they go back into the less and less and go to visit a cardiologist's office. And that's where a lot of the prescribing, you know, most of our prescribing for ARCALYST is from cardiologists, but also from rheumatologists as well.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Just in terms of the small percentage of patients who drop off, I think you talked about 85%, you know, stickiness, give or take, that 15% or so that are lost. Is it primarily due to, you know, let's say job switches or insurance switches, you know, flip of the calendar year, events like that? Or is it a view that, you know, oh, my, my symptoms are gone. I, I feel better. I'm just going to stop my meds. Just kind of what's the primary driver of, of patient loss here?

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Yeah. I mean, it's a variety of things. I mean, very often it also could be other complications, other diseases that are actually interrupting, and people, you know, forget to take their medication because they're dealing with something else at the time. Or as you say, it could be just life in general. But so far the rate of compliance has been very high. How much you want to add to that, John?

John Paolini
EVP and Chief Medical Officer, Kiniksa

Yeah. So, you know, in terms of patients coming off of therapy, I mean, it, you know, as Ross mentioned, it's a, you know, a chronic disease treatment, you know, three years. One thing that one has to always be careful about is that while on therapy, patients feel well. And so the fact that the patients feel well is not the reason to stop. In fact, you know, really need to treat for the duration of the disease. And so what we learned again from the clinical trials is that at some point, you know, clinicians and patients have to come to a decision about whether they think they've come to the end of their treatment course.

And if so, you know, cessation of therapy or suspension of therapy and letting the drug wash out to see if the disease is still present, you know, behind the scenes, is an established way of testing that. And what we've learned both from the clinical trials as well as in the real world is that if you stop the drug and as the drug washes off, if the underlying disease is still present, it will come back. And there's usually a prodrome of symptoms that then allows the patient to reinitiate therapy, and that was demonstrated in the clinical trial.

And so that provides, you know, I think, a substantial framework for the doctor and the patient to figure out, at least from a duration of disease perspective, when to stop. And, you know, that, you know, contributes to some of that number, and then maybe there are some other factors as well.

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Yeah. That's right. I think sometimes it's when patients stop and come back onto therapy. You said it for, in Q1, often the change of insurance and so on kind of takes a bit of a time lag, for the time to the next refill. So there are elements like that, and there are other complications of other underlying diseases or, you know, if someone's going in for surgery or has infections and so on, there are other reasons why you can hit the compliance rate.

But overall, we're very pleased with the compliance rate. It's greater than 85%. It's a robust compliance rate. As we mentioned earlier, we have Kiniksa One Connect as our patient service program. We've had some very with our patients, and as part of that, it's a compliance and adherence program that we run with patients as well to support them all the way throughout their journey with ARCALYST. So generally, we're always looking at ways of improving and constantly fine-tuning and incremental improvements. But we're generally very pleased with where we are with the compliance rate.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Your launch to date has been sort of controlled and focused and targeted to a select, you know, sort of prescriber base, but there is also a larger tranche of patients, you know, who are not necessarily being targeted, which is, you know, those pericarditis patients with a, you know, first recurrence once you reach sort of your target threshold population of sort of the first, you know, tranche of centers and patients that you've been focusing on. So, you know, how do you, or when you sort of think about you might be at a point to target that sort of next tranche of, call it 26,000, 30,000-ish patients, that represents the next sort of opportunity for growth here?

Sanj Patel
CEO and Chairman, Kiniksa

I mean, the time is now. We've been thinking about it for a while. I mean, we have said recently we've reached around 2,000-plus prescribers so far. The bulk of those are those 14,000 that have two or more recurrences. But there are a good body that are on their first recurrences, as Ross mentioned earlier. The label is so broad that it allows the treatment of recurrent pericarditis, whether on their first or whether on their second or third or fourth, etc. so that's now. And I think the broad educational program that Ross mentioned really goes to the fact that we can treat at both ends of the spectrum.

And certainly going forward, we do probably plan to see more and more patients and having an outreach that focuses on physicians that have seen those patients with their first recurrence. So it's definitely part of the program, but not, as you say, in that core 14,000, but beyond that. There's certainly an upside potential there without a doubt.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. I guess ultimately, as you think about the longer-term opportunity, can you maybe remind us, you know, how you size up the TAM here in RP, I guess? I feel like, you know, when I speak to investors, this, you know, people just worry about the quarter or the annual guidance, but, you know, they sort of kind of miss the bigger picture that there's a very large opportunity set here. And then secondly, the business, as you guys disclose with each quarterly results, is actually profitable even after the profit share and cost share with Regeneron and just are being spit off by the business currently.

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. I mean, as far as ARCALYST, as we know, is the first approved therapy. We've had a phenomenal trajectory to our launch. We've had, I think, from Q1, it was roughly an 85% year-on-year growth. We certainly expect to increase that, you know, as far as ultimately where it goes, remains to be seen. But we believe there's a lot of opportunity for us and ARCALYST to penetrate much further. We've most recently announced a 9%. We hopefully, obviously, plan to increase that significantly going forward with ARCALYST.

Beyond that, I mean, again, remains to be seen as far as, where, where it goes in the future. You know, as far as cash flow positivity, certainly we have said that we are cash flow positive on an annual basis. We have an awful lot of flexibility, not just to invest in ARCALYST and continue that penetration and growth, but we can invest in our business and our clinical development.

I'm sure we'll get to that in a second. And I can summarize for everybody, you know, what, how excited we are about the company as a whole. But certainly with our cash position and our cash flow, we're able to invest not just in ARCALYST, but as I said, in clinical development. I'm sure now we'll talk about how we prove our.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah.

Sanj Patel
CEO and Chairman, Kiniksa

And the applications there. You know, we announced that we're now moving into a phase II in Sjögren's, this year, which is very exciting. And that's on the heels of some compelling phase II data in RA. But the cash flow allows that as well. And it on top of that, it allows us to look at potential other areas of growth within the clinical field as well. You know, we can't forget business development. It's been one of the key pillars and the key strategic areas for the company. It's how we started the company from a blank piece of paper just about eight years ago. So, that cash position allows us to be extremely flexible, but also invest in the future and invest in growth.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah. It's always interesting to me. I mean, you can count, I can count on my fingers and then with companies that sort of fit your profile with an approved product, you're in a rapid growth phase of your launch, but already achieving, you know, cash flow, you know, cash flows with that commercial side of the business at least, but also, you know, supporting your pipeline. So I think your profile there is very unique.

Sanj Patel
CEO and Chairman, Kiniksa

But, you know, financial discipline is also a very important part of that, I think. You know, obviously, you can have the growth with your commercial products and you can invest in business. But we've been, I think, very, very strongly focused on financial discipline and ensuring that we, you know, we give a good handle on the burn. So we've done that, I think, historically for the last few years.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Maybe turning to the pipeline plan, as you brought up and talking about how we prove our, I guess, maybe can you just remind us in terms of what updates you'll provide with regard to your Sjögren's study initiation and just sort of, you know, what pipeline or enrollment updates, maybe to start there with the phase two trial and just sort of what sort of news flow we can anticipate over the next, call it, 12 to 18 months, give or take, John?

John Paolini
EVP and Chief Medical Officer, Kiniksa

Yeah. So, yeah, we, as Sandra mentioned, we're pleased to announce that we'll be starting a phase IIb study in Sjögren's disease in the second half of the year. We've disclosed publicly a little bit about the study design, and we can certainly talk about that. You know, ClinicalTrials.gov is a great place to go routinely for updates about trial enrollment at this point. You know, we've announced that we're our intention to start and, you know, watch this space, more to come, about the timeline of recruitment and ultimately the data.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. You know, this is, I think, a space that's sort of actually fairly closely watched by biotech specialists, given that there are multiple drugs, you know, in development for Sjögren's here. So maybe just starting with the trial design, John, and sort of as you think about, you know, inclusion/exclusion criteria, you know, in contrast to maybe some of the other agents that are clinical stage, can you maybe comment a little bit on, you know, how you're thinking about trial design here and what sort of patients you want to include or and/or exclude?

John Paolini
EVP and Chief Medical Officer, Kiniksa

Sure. I mean, it's important to point out that, so far, there are no approved products in Sjögren's disease. And so the regulatory path is still, you know, being worked out, about what exactly the approvable endpoint will be. However, where the majority of sponsors seem to be focused is on measures of disease progression and a particular score called the SDI, where the clinician evaluates the disease state of the patient over a range of certain domains, and it's a composite score that's added up. And so, what we've announced is that, you know, we'll be following that similar established paradigm in terms of looking at those disease scores in order to find patients with substantial enough disease to provide the dynamic range that we'll be able to see a treatment response.

It's a 24-week treatment period, where we have two different dose levels of abiprubart versus placebo, and that's where the primary efficacy endpoint is described. And then we have an additional 24-week treatment period that's where it's all active drug, and that allows us to look at kind of the long-term performance of the drug. The good news is that with regard to this mechanism, it's been fundamentally de-risked by external proof of concept, both in terms of CD40 antagonism as well as CD154 antagonism. So I think we have a wealth of experience to draw upon, both to consider the you know the target de-risk, but also to help us with some of the trial learnings, as you mentioned, across the competitive landscape to hone our trial so that it's optimized, you know, for the data collection.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Great. Could you maybe, you know, speak about, you know, how you view the potential, differentiation or what's, you know, unique, I guess, about abiprubart versus some of the other CD40 assets that are out there that have put out clinical data in Sjögren's, whether it's iscalimab or Dapirolizumab, and just sort of what factors, whether it's dosing, Cmax, whatever, you think stands out as potentially differentiating, versus some of the competing assets in the category?

John Paolini
EVP and Chief Medical Officer, Kiniksa

Sure. Yeah. No, we're particularly excited about the high-concentration liquid formulation that's been developed that, we believe, enables chronic subcutaneous dosing at a very practical dosing interval. So, in fact, in the structure of the trial, it's anchored on biweekly dosing. However, for example, the competitors that are in the space, you know, may have biweekly subq dosing or IV only, even whatever that interval might be, whether it's biweekly or monthly. And so the high-concentration liquid formulation of abiprubart, it allows us to, you know, to anchor on a biweekly dose, but then also to even test whether taking that subcutaneous dosing to a monthly dosing interval, you know, is efficacious against placebo.

And so in that sense, this study, you know, really, you know, is designed to show not only the core efficacy of the asset, but also, you know, a potential for differentiation in terms of, you know, convenience of dosing in a way that's, you know, practical for patients.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Great. I want to talk a little bit about the data you've put out already for it in RA, you know, which I think was super interesting. And I think stats aside, you know, there was clearly evidence of a signal there . I wanted to just sort of ask, you know, what is the interest in continuing to pursue RA as an opportunity in the autoimmune space? Is this something you'd want to, you know, further develop either as a standalone company or something that you'd want to think about partnering that particular indication out, which, you know, brings its own sort of complexities to think about, you know, indication-specific partnerships? But just curious, you know, what sort of the next steps might potentially be here in RA?

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. I mean, as you mentioned, we were very compelled by the data we received, particularly the rheumatoid factor data that we saw in the phase two study. And that, I think, gives us a lot of, you know, hope and promise that there is a potential there in broad indications such as RA. Now, you know, I think the idea we've obviously been open to BD deals in the past. We've done some very exciting business development deals. And so we're certainly open to it. You know, we'll continue the program right now within Sjögren's. We are looking at other indications, whether they be in the rheumatology space or the neurology space. But, certainly, RA is not lost unless there's a potential there. And we may well consider a partnership at some point going forward.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Maybe after Sjögren's, you know, Sanj or John, you know, how would you prioritize sort of potential next development opportunities? I think we've all heard from Sanofi's recent R&D day. You know, they, they've talked about Sjögren's, but they've also talked about adjacent opportunities. You briefly touched on neuro, including, you know, potential CD40 in, in, you know, large disease states such as multiple sclerosis or certainly other I&I opportunities there as well. And so, you know, in terms of development programs and that, you know, additional shots that might be possible for abiprubart, what, how would you sort of rank order them? And, you know, sort of what do you need to see, I guess, from your Sjögren's program, I guess, to maybe advance to the next indication potentially?

Sanj Patel
CEO and Chairman, Kiniksa

I mean, we think about it very carefully, and I don't think it's mutually exclusive. I mean, obviously, as you said, we've been watching the competitive profiles very carefully. A lot of it comes down to the commercial opportunity. I mean, certainly, there are indications, as you mentioned, that are very broad and that have an awful lot of potential and that could potentially allow more than one or two entrants. And being a fast follower is something that we're certainly open to. But, and again, depending on the data, we're certainly going to start this Sjögren's study, imminently. And then beyond that, we'll look forward to elucidating next steps for the program. But certainly, rheumatology, neurology, as you say, are real strong, you know, areas that we could focus on for abiprubart.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Great. I'm turning maybe a little bit towards some corporate questions and just sort of BD. I think, you know, one of the BD questions I think that is always sort of outstanding with you guys is, in terms of either partnering your clinical stage assets where you, you've had proof of concept like mavrilimumab, and just sort of where next steps might be for that program. Just maybe if you could provide an update on just how you're thinking about BD there for that program.

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. Just as a reminder, mavrilimumab is an antibody antagonist that we took through phase IIb studies in giant cell arteritis. It's shown positive data there as well as safety in that indication and previously in RA. Yeah, we still think there's a lot of, you know, potential for that molecule in a number of indications, and we are potentially looking at partnerships there. Ultimately, with that program and other programs, it comes down to the amount of value that we can create. So that's the ultimate deciding factor for us. But we do believe there's a lot of potential there, and we are looking at partnerships for it.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. In terms of other corporate matters, I guess, you know, you've talked about remaining cash flow positive while potentially advancing abiprubart in the next couple of years or a few years to a phase III clinical development program and your cash runway. I guess if you could maybe remind us where it currently stands in terms of funding both the phase III program and, or BD efforts.

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. So we're cash flow positive on an annual basis. Cash reserves are around $213 to 214 million. You know, ultimately, we are a growth-oriented company, extremely well-capitalized. But as you mentioned earlier, we've done some phenomenal BD deals. Ultimately, though, we've, I believe we've got one of the best teams of biotechnology, and we think about capital allocation very, very carefully. So there are a lot of opportunities in front of us. The cash flow position does allow us to be very creative and flexible. But ultimately, we'll make the right decisions at the right time. Ultimately, we're very much focused on creating value in the, in the near, mid, and long term.

And so that's what's going to guide us going forward. The beauty about the pipeline, it is somewhat, you know, broad in terms of both cardiology, as you said, rheumatology, potentially neurology. And that allows us to make some very important decisions, but we'll be very, very judicious. As always, as we've shown over the last 16 years between two companies that many of us have worked on together, we've shown that we can be extremely good stewards of stewards of capital, and we're extremely economically responsible. If we do a BD deal, it'll be the right one.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. I want to ask maybe in our time reminding on, you know, you have assets in the clinic in terms of abiprubart and a commercial stage asset with ARCALYST. But in terms of earlier stage development, you know, just kind of this is something I think with your story that doesn't get a lot of airtime.

Just curious, you know, what your scientists are working on in terms of the background that you may not have necessarily disclosed versus in licensing an external asset that may be, you know, clinic-ready or something like that. Just kind of, you know, is that something you want to start talking a little bit more about? Should we expect more INDs coming out in the next, you know, one to two years? Just, you know, is that something you feel like is something that needs to be prioritized just to, you know, think about adding another leg to the Kiniksa story?

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. Absolutely. I mean, we do have scientists. We do have an early stage group without a doubt our own laboratory as well as our own early stage manufacturing. They are working on some excellent stuff. A lot of that is either in the cardiology, rheumatology, or potentially neurology space. And, you know, obviously, we'll disclose those at the right time. But we are thinking about growth both from a BD, both from a clinical, commercial, as well as, you say, early stage research point of view. So it's definitely a case of watching this space. I, you know, our intention is to be a leader in various franchises, whether that's the IL1, whether that's in, CD40 mechanisms. You know, we intend to make a lot of value and help a lot of patients.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Great. In our closing minute or two here, maybe Sanj, to close out, maybe as you think about sort of the investment case here for Kiniksa over the next one to two years, maybe what would you highlight as maybe sort of the most underappreciated or missed opportunity in terms of the company's potential?

Sanj Patel
CEO and Chairman, Kiniksa

Yeah. I think it's all of the above. I think the launch of ARCALYST has gone incredibly well. I think that's taken people a bit by surprise. But as obviously as Ross and I talked about, we expect to continue that growth. That's definitely an underappreciated area. abiprubart, I think, you know, if you look at the phase II data generated today, incredibly compelling, very excited about the Sjögren's study and looking into potentially other areas and business development.

You know, it's obviously, as I said, we've created this company from scratch, blank piece of paper about eight years ago. So we're very excited about the future. And as you said, that you could count on less than a handful, less than a pinky as to how many companies are in our position. So we continue to execute both commercially, clinically, as well as from a corporate fiduciary standpoint.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Great. So we're nearly up on time here. So my thanks to Sanj, John, and Ross for joining us, and we'll end it on there. Thank you.

Sanj Patel
CEO and Chairman, Kiniksa

Thank you, Paul.

Ross Moat
SVP and Chief Commercial Officer, Kiniksa

Thank you.

Powered by