We'll continue with our next session. I'm Paul Choi, and I cover the small and mid-cap biotechnology sector here at Goldman Sachs. It's my pleasure to welcome the management team from Kiniksa. We're joined by, to my left, CEO Sanj Patel. We also have Dr. John Paolini, CMO, and we have Ross Moat with commercial. What we'll do, as we have in prior sessions, is let Sanj get off with some high-level comments. We'll go into Q&A after that. If any audience members along the way have questions, please feel free to raise your hand, and we'll try and get a mic to you. Alternatively, if you're listening on the webcast, please feel free to email us your questions, and I'll read them anonymously.
With that, I'll turn it over to Sanj for some opening comments.
Thank you, Paul. Great to be here. Obviously, we've also got Eben Tessari here, who's our Chief Operating Officer, and Mark Ragosa, who's our Chief Financial Officer. Great to be here. Obviously, Kiniksa had a lot of changes, a lot of progress over the last two years in particular. I do want to say, start by saying that we will be making forward-looking statements today that are subject to risks and uncertainties. We review those statements around in our SEC filings and the risk factors. ARCALYST is off to a great start. Two years now into launch, our first commercial product, which is an IL-1 alpha and IL-1 beta, indicated for recurrent pericarditis, actually the first and only approved FDA therapy for recurrent pericarditis. Two years in, we've seen quite a successful launch.
We also, I'm sure, go into much more detail as far as how that launch has gone. We started off with around 29, 30 sales reps, have now increased that to 50 and seen the early signs of that really helping us increase our revenues. In fact, actually, we're now guided to $200 million-$215 million for the year, which is up from our previous guidance, which was $190 million-$205 million. That's obviously been a great start, and I'm looking forward to really drilling down and give you an overview of that. Beyond that, though, we do have a pipeline of other programs which we're very excited about. One in particular is our KPL-404 program.
That's a CD40, CD154 molecule, currently in a phase II study in RA. That reads out in the first half of next year. We have said that we've completed enrollment in the cohort one and cohort two, and we're now enrolling in our cohort three of that program, so very exciting. This molecule, by the way, is a molecule that Kiniksa owns pretty much all of the economics around that. In addition to RA, there are other indications that we think we could follow, not necessarily exclusively just with the positive results from the RA study. Very exciting to really progress that program, and I'm sure John can go into the details of that and happy to answer any questions on that. Beyond that CD40 program, we do have mavrilimumab. Very excited about that. It's anti-GM-CSF.
Molecule has really been through phase II studies, shown positive results, in fact, both safety and efficacy in both RA previously, when AstraZeneca and MedImmune had had it. With ourselves, we took it through a phase II in GCA. Again, saw positive results and also looked at it in COVID. We've now really pivoted and really focused now on rare cardiovascular indications, which really provides synergy with our existing cardiovascular sales force. Looking forward to progressing that. We did last year, out-license our vixarelimab program, which is an OSMRβ, IL-31 molecule. We were focused on PN, but Genentech Roche were very keen on really developing that in more fibrotic indications. We did that deal, which provided us at least $100 million in upfront payments, as well as some milestones down there.
That was really a capital allocation decision, allowing us to really focus on the CD40 program, expand the commercial footprint around ARCALYST and recurrent pericarditis and the rest of the pipeline. A very busy couple of years, as I say, for Kiniksa. Very excited, but happy to answer any questions.
Great. Thanks, Sanj, for that overview. One of the, you know, classic roles in biotech investing is that you short the launch, but you guys have proven the exception to the rule here, and investors are embracing the ARCALYST launch here. Which is going well, and you are one of the few companies who are able to raise guidance as early as, you know, Q1 here. Congratulations on that. I guess, you know, maybe question one for either you or for Ross is, you know, where are you know, relative to plan in terms of, you know, penetrating your initially identified target accounts and prescribers?
Yeah. Thanks, Paul. Maybe I'll make a start on that. I think probably two things. Firstly, how we're getting on penetrating the actual total market, which, as you know, was previously an unmet market. We became the first and only proof therapy in recurrent pericarditis, and then maybe go on to the, the target base physicians and accounts and how we're doing around that. One thing that we did share earlier on this year is that at the end of 2022, we achieved around a 5% penetration into the 14,000 target population opportunity that we are focused on.
That 14,000 patients are those patients that have two or more recurrences, and that's our key target population that we go to, where it has the most overlaps with the RHAPSODY Phase III study, where we saw very compelling results, and where we think there's the biggest call to action for physicians to really address patients with ARCALYST. That 5% indicates ultimately that we are making good progress, as you've seen from the revenue numbers. We landed at $122.5 million throughout 2022, hitting that 5% penetration. It also tells us that there's a big opportunity ahead of us to go after.
Even though we're two years, just over two years into the launch now, we think we've got a very long runway ahead and are still fairly embryonic on the journey that we're on to helping patients, in recurrent pericarditis.
The other side of it, thinking about physicians and accounts, is just that we share on our quarterly earnings calls how many physicians have prescribed ARCALYST, and we've seen that steadily grow quarter on quarter since the time of launch. Indeed, up until the end of Q1, we had more than 1,000 physicians, mainly cardiologists, some rheumatologists, and some other smaller specialties as well, but predominantly cardiologists, who have prescribed ARCALYST in recurrent pericarditis. About 23% of all of those have prescribed in multiple patients as well. I think the growth there, and that constant growth, and in fact, in the Q1 versus Q4 of last year, was the highest growth that we've had in more than 200 additional physicians that have prescribed.
I think that highlights the trajectory, and the need that there is out there and how patients are, you know, across the U.S., being treated by many physicians. We are starting to make good progress in addressing the awareness around recurrent pericarditis, and indeed, ARCALYST are making people comfortable at prescribing a biologic to address this condition.
Okay, great. If we dig into some of the drivers of the launch, you know, one of the things that's emerged as a tailwind for ARCALYST is the duration of therapy here, which continues to inch up a little bit each quarter, I guess, to put it. I guess, you know, even relative to the RHAPSODY study, and, you know, patients who have also discontinued therapy are returning to therapy as well. You know, a couple questions here are, you know, what is happening first on duration? Second, you know, how would you characterize the, you know, market understanding or physician understanding? Is there a view that, you know, ARCALYST is not just an acute treatment? Is there an emerging view that this is sort of a maintenance therapy?
Can you maybe comment on those two things?
Yeah, maybe I'll make a couple of broad comments, and then feel free to jump in. I think you're right, duration has steadily increased since the launch. I think we initially predicted, you know, less than 12 months, but we've seen now an average duration of around 20 months. Still relatively early, as Ross said, in the launch, about two years in, so hopefully that will continue to develop. We have seen a steady increase in awareness of physicians. You know, obviously, the increased size of the sales force has helped us. One of the things we're focused on now is really increasing the number of centers of excellence. A lot of the information that we've been able to provide is data from the registry.
Our extension data from the initial RHAPSODY study has been very important in showing physicians that really it's important to treat patients throughout the course of the disease, and that therapy, that duration of disease could be around three years or more. Having a longer duration is important. I think it's obviously a work in progress. You know, a little bit early to sort of say exactly where it's going to end up, but it certainly has been increasing over time. Ross, anything to add?
Yeah, I think you've outlined it very nicely. Just to give you the numbers behind that 20, average 20 months worth of duration on therapy in total per patient, is that we generally see that initially, patients are on for around 14 months, on average, before trialing a stop. About 45% of all those patients who have stopped ARCALYST therapy actually go back onto therapy, the vast majority within eight weeks of stopping the therapy. I guess the part that's where the data is building is when the patients go back onto therapy, how long do they stay on therapy for? That's kind of an evolving picture, and particularly as that data becomes more robust, we look forward to sharing more on that further down the line.
The average is about 20 months right now. Against the backdrop of the natural history being around three years, for multiple recurrent patients, but also going out, about one third of these patients still have disease at the five-year time period, as well. We are really trying to educate physicians on the natural history of the disease, as well as how to treat with ARCALYST. I think that's the mindset shift, to the second part of your question that we've been focused on with our field team and our medical affairs activities, sharing information around that. Of course, historically, physicians often treated this disease with a viewpoint of, reducing the amount of treatment time, as much as they possibly could.
For one reason being that, you know, corticosteroids were a way of treating, you know, difficult to treat patients. If you're treating with corticosteroids, with the toxicity effects and the burden, and we know that it prolongs the disease, you want to try and get patients off treatment again as quickly as possible, and that creates problems with the patients suffering from the disease in multiple recurrences as well. Now, the mindset needs to be shifted towards treating throughout the duration of the disease. I think that's what we're making good progress against, which is what the average, you know, treatment duration is starting to show us. There's a lot more to be done.
Maybe, John, just kind of what the open label extension data suggests on that front as the, maybe the longer-term potential. Could you maybe comment on that?
Sure, absolutely. The long-term extension data really provided the scientific foundations for you know, for understanding that recurrent pericarditis is a chronic disease that can last for years, and that the flares are driven by IL-1. In that sense, it extended the median duration of treatment in the base study, which was nine months, now out to, you know, to almost two years, with the longest durations out to three years. That gave clinicians really a solid data foundation for understanding how the drug was used. Importantly, I think a critical piece of data that was really eye-opening was that there was a decision milestone after 18 months of treatment.
What it showed was that even in patients who had been treated for 18 months, which many would have thought would have been enough, suspension of therapy at that time resulted in a 75% recurrence rate. That kind of hammered home the message that there's a 98% reduction in the risk of recurrence, even beyond the 18-month time point.
Okay, great. Maybe just to follow up that, circling back to Ross, when patients come back onto therapy, is it because they've had an acute event or a reoccurrence? Is that the general driver that you're finding in terms of your database or data so far?
I think that's generally anecdotal to what we're hearing, and I think would make sense based on what we've seen from the clinical evidence as well, when patients have had temporary interruptions in their treatment, and based upon what we know from the PK profile and the washout profile of ARCALYST. Generally, you know, if you stop treatment too early and there's still underlying autoinflammation going on with the patient, and you are unmasking that and bringing back on symptomology. You know, the good news is that there is a wealth of data to show that if you treat patients again, take them back onto ARCALYST therapy, that they get the disease back under control rapidly as with the first time around.
Ultimately, we want to try to educate for that longevity of treatment and avoid patients going through those, future exacerbations of flares.
Okay, great. Maybe just speaking to your sales force interactions and just kind of what it takes to get a whether it's a cardiologist or other type of physician on to get to prescribe a drug. Can you maybe comment a little bit on what recent dynamics have been like? You know, maybe what is sort of the, you know, key barrier to physician prescribing or adoption potentially? Are they looking for other drugs in your in the bag to come in sort of a portfolio approach in terms of taking up ARCALYST, or is it more just single focus on RP here?
Yeah, maybe I'll start. I mean, I suppose initially it's focus on RP. I mean, historically, cardiologists have not been so used to prescribing biologics. You know, we've got a split of around roughly 75 to 25 cardiologists versus rheumatologists. Rheumatologists certainly are more, attuned to, prescribing biologics. Our effort has really been, as I said earlier, increase the awareness, but also introduce the fact that this is a very important therapy for these patients that have gone, you know, without therapy for so long. The RAPTI data has been so compelling. It's really been a great tool for us to be able to convince them this is the right thing to do.
Again, these centers of excellence, I think, are very important, and it would actually set up a lot of referral networks via some of the initial centers of excellence that have helped really educate the rest of the physicians. That's a work in progress, but it's actually been really well and going towards the penetration that Ross talked about to help increase it. Right now, ARCALYST is our main focus. We obviously have a pipeline of programs, and we are looking at synergies. We're looking at rare cardiovascular indications with mavrilimumab, but also open to actually, you know, as you say, adding to the bag via additional business development, you know, ideally within cardiovascular or immunological areas. We're looking at a number of different areas to sort of increase that commercial footprint.
Yep. Yeah, I haven't got much more to add to that, other than we remain focused in terms of our targeting approach with our field team. You know, we increased our field team to around 50, as Sanj said at the beginning, in order to increase our breadth of physicians that we can get to, but also increase the frequency. To your point around the multiple calls, we do have a lot to try and achieve within our sales calls, or indeed from the medical affairs side as well, when we're speaking with physicians, and that's related to the education on recurrent pericarditis and distinguishing it from the acute episode, or the indexed episode. And also around ARCALYST.
As we said, bear in mind that biologics are reasonably new for the cardiology community to prescribe, so there's a lot of questions around that and how to prescribe, even just operationally, how to monitor patients when they're on therapy and so on. It does take multiple calls to bring physicians to the level where they're comfortable and familiar, and then, of course, identify the appropriate patients. Bear in mind, it's a rare flaring disease. So it is a process, but that's one reason why we increased the size of the field team. You can see from the prescriber numbers and the growing revenues that we have, that we're making good strides.
Right. Sure. To your point, their experiences have probably been, in biologics, have been, among cardiologists, have been largely limited to PCSK9-
Right.
which were always challenging to get, you know, payer approvals for.
Exactly.
historically. Maybe, in terms of other sort of market dynamics, I guess, you know, how would you characterize you know, brand awareness of ARCALYST at this point? You know, you mentioned earlier that you're, you feel like you're still early innings in terms, or embryonic, I think, was the word you used, in terms of, penetration of the prescriber community. I guess, how, you know, how would you characterize market awareness of a, of a treatment option being available for RP at this point?
Yeah, I think it's been growing substantially since the time of launch. Having the first and only approved therapy in an indication automatically gets, you know, that excitement and interest and wanting to kind of dive into the data and understand how the treatment paradigm is evolving and changing over time. I think we're making good progress against that, as you see from all the numbers. Yeah, there is a huge amount of work to be done there. As, as Sanj alluded to, you know, patients at the moment are very widely dispersed around the U.S., because there are a limited number of centers of excellence looking after these patients that have referral pathways for, you know, pericardial diseases.
As the interest grows and more centers grow and kind of create referral networks and so on, I think that can only be good for everyone in the, you know, all the stakeholders involved.
I mean, I think you can set the 5% penetration in two ways, right? Certainly, two years in, you could say, "Well, that's not terribly an awful lot," but the opportunity that we have now to really increase that is what we're focused on right now.
Great. In terms of patient behavior, in terms of refills and sticking to their scripts, how much is maybe coming from your targeting more patients versus patients who have been on therapy and just maybe understanding the components of growth that you've been able to demonstrate these past few quarters?
Yeah, it's a great question. We haven't shared exactly what the percentage split is between existing patients that are getting refills and new patients coming in. You can take from the fact that we've been growing steadily quarter on quarter, so the fact we're adding a lot of new patients along the way. For the existing patients, because the average treatment duration is 20 months, so that's, you know, that there is a high degree of existing patients.
Yeah.
that are, again, getting refills on a monthly basis. Bear in mind that the compliance is very high, very, very strong within this disease. We add a lot of support to patients through patient services and adherence programs and so on, associated with that. We really try to look after those patients that are the existing patients, to make sure that they have the duration of therapy that they require. Of course, the more patients you have on therapy, and this is not, you know, a lifelong condition, so, you know, patients do drop off every single month or quarter as well.
The new patients that we enroll into our services and programs and get a prescription for ARCALYST and come onto therapy for the first time, obviously have to outpace those patients that drop off in order to kind of keep getting the growth. That's exactly what we've seen every single quarter since launch.
Great. I do want to give the audience a chance to ask any questions on the commercial piece. If there are any, please feel free to raise your hand, and we'll get a mic to you. While we're waiting on that, maybe I guess, you know, one question I guess at this point into your launch for either Sanj or Ross, is just where are, or if any are, any payer gaps remaining, any, you know, major plans or anything that have still continued to push back and just say RP is not something, you know, that we think is real, despite the approval of ARCALYST and just sort of, you know, what's left in terms of, you know, working on the payer side?
I mean, our approval rate for payer has been very strong since launch, over 90%, and it continues. There are obviously some payers that continue to have questions and as we have the renewals coming at the beginning of the year, but generally, it has gone very, very well.
Yeah, absolutely. It's been greater than 90% every single quarter since launch, and that's really across the board, whether it's commercial, Medicare, Medicaid, as well. We're pretty pleased with how payers have really accepted the value proposition and the work that we did building up to launch and since launch. I think the very compelling results coming out of RHAPSODY certainly help with that.
The extension data, as well.
Great. You know, one of the questions we get from investors and clients is just understanding, you know, who is being treated here in terms of the early stages of the launch. Are you just sort of getting the low-hanging fruit? If you were to sort of characterize the patients at this point, are they mostly the patients with severe disease? If not, you know, or if that is the case, you know, how do you think about potentially penetrating over time into patients with less severe disease?
I think it's a mix. I mean, I think certainly, you know, post-approval and in the early stages of launch, you do get some of the low-hanging fruit, as you say, some of the more severe patients that have been waiting for therapy. I think even as we've sort of expanded our reach across the country, we've found that we are getting new areas, new centers of excellence, where you're still finding very severe patients. It's a general mix, without a doubt.
Yeah. Yeah, absolutely. The, the majority of patients that are prescribed ARCALYST for current pericarditis are within the 14,000 target population that we're focused on from a field team perspective, and targeting physicians that have the highest throughput of those 14,000 patients. The vast majority are there. We do have some patients that are also, you know, higher up or earlier on in the disease course, if you like, that are on their first recurrence. I guess that alludes to the, you know, the broad label that we have from the FDA, which does not stipulate the number of recurrences that a patient must have had previously.
That allows the freedom for physicians to really pick and choose where they believe ARCALYST can really help their patients to a lesser extent than those patients there.
I think maybe just elucidating some of the information we've got from the extensions studies, I think are very important in helping educate physicians as to why they continue to see these patients.
Yeah.
The extension data are useful there, as well as, the actual registry, which is going on now, which is RESONANCE. You know, if you think about, it's a network, if you will, of centers across the country. When it started, the registry, it was, there were six of the centers that were in the clinical trial, and now it's expanded out to 22. That tells you that you have centers that are really paying attention to pericardial disease. Then within that allows us the opportunity to see what types of patients are going on to therapy at these centers.
It's not the entirety of the, you know, the depth of the dataset that, that Ross is dealing with, but at the same time, it's a representative dataset, from a research perspective. Again, it shows you many of the trends that Ross has mentioned, which is, you know, the, the utilization across the spectrum, of disease, as well as kind of how patients are coming onto, ARCALYST, you know, therapy from, not only corticosteroids, which is kind of the old paradigm, but now this newer paradigm of coming directly from NSAIDs and colchicine, skipping the steroid step and going directly, you know, into ARCALYST as the approved therapy. I mean, I think that's kind of what the data are now, you know, showing, and that, of course, is shown at scientific meetings.
Great. maybe to help us understand the size in terms of like, you've identified this initial tranche of 14,000 patients that you think are sort of the initial opportunity. As you think about patients who have maybe had, just had their first reoccurrence or are gone a long time between recurrences, what does that additional, you know, sort of patient pool look like in terms of helping us size up the opportunity here?
Yeah. That additional patient pool would be an additional 26,000 patients on top of the 14,000 that are the multiple recurrences. Another 26 that are just, in any given year, are just on their first recurrence of pericarditis. The totality being 40,000, 40,000 population there.
Okay.
That would be what was covered under the, under the label, that we have in the U.S.
... Maybe, turning to the pipeline, and maybe I'll, John, this question here, can you maybe just talk about maybe the enrollment status, Sanj mentioned a little bit on, you know, cohorts one and two being fully enrolled for KPL-404, and just kind of where you are with regard to cohort three and your RA program?
Sure. Well, we're very excited about the KPL-404, as you might imagine, a very strong asset, you know, blocking CD40, CD154 interaction. You know, lots of, you know, external proof of concept that has preceded that. It gives us a lot of confidence in the mechanism. What we're excited about with KPL-404 is, you know, moving beyond the phase I single dose program now into the multiple ascending dose program, having gone through those first two cohorts to kind of establish the PK parameters, and now really focusing on demonstrating the efficacy of KPL-404 in rheumatoid arthritis. Cohort three is established as a way of taking a very workable subcutaneous dose, which is, I think, the advantage, if you will, that we're seeing with KPL-404, is that you can deliver a large amount of drug subcutaneously.
We're testing a 5 mg per kilo, a very practical dose, that can be administered either biweekly or weekly, compared to placebo. It's a 12-week, 12-week endpoint, which is, you know, relatively brief in immunologic studies. That program is progressing, and we anticipate data in the first half of 2024.
Okay, great. For people who may not be familiar with the CD40 landscape, could you maybe just highlight for us, you know, what are some of the differences in terms of the differences that KPL-404 has relative to some of the other drugs that have been out there in the category? We have seen some other data from competing assets that use a similar approach, maybe just, you know, what it does in terms of targeting and potential differentiation there.
Sure. I mean, I think what it does is it establishes the real opportunity here, right? In the sense that you can. It's a co-stimulatory interaction, so you can block either CD40 itself or the ligand, if you will, or CD154. The CD40 is on B cells and antigen-presenting cells. CD40 ligand or CD154 is on T cells. Different assets in the space have targeted that differently. For example, you might know of Horizon's molecule, for example, which is dazodalibep, which is blocking the CD40 ligand. On the other hand, you have.
The former Viela asset.
The former Viela asset, right? Exactly. On the other side, you have something like iscalimab, which is blocking, you know, CD40 directly. If you look at, you know, a lot of the evidence that's there, it shows the potential of the mechanism. The real question, though, is: How do you deliver that to patients? If you think about something like, you know, dazodalibep, you know, powerful efficacy, but requires large amounts of protein to be delivered intravenously at relatively frequent intervals. While you get the efficacy, there's the, you know, convenience factor.
On the other hand, you know, we have iscalimab, which has done well and, you know, covering a range of different indications, and has done well with as an intravenous dose, but perhaps has done a little bit less well so far, with a subcutaneous dosing. I think, you know, the way we've developed KPL-404 in terms of the program, is to focus down on having a high concentration liquid formulation that's very practical, in administration. Our data show that the 5 mg per kilo subcu dose was roughly equivalent to the 3 mg per kilo IV dose, which then opened the door, to being able to attack, you know, chronic diseases in a way that's good for patients. But more to come, of course, with the data.
Great. RA is kind of a well-known landscape to the investment community. Just as you think about your study here and the what you're trying to show, could you maybe highlight for us, you know, how you're thinking about, you know, what the relevant metrics are in terms of the RA landscape, why you think of focusing on, you know, certain metrics versus other metrics in terms of your development?
Maybe I'll say a little bit about the science of what we expect from KPL-404 in RA and why we made that choice, and then I'll turn it over to Sanj. Yeah, in terms of why we made this choice for phase II, rheumatoid arthritis is, as you said, a very well-characterized disease. One of the advantages of it is that, you know, there's a lot of history in terms of how to establish a dose range, as well as the fact that you can get to very practical endpoints in a relatively short period of time with a relatively small number of patients.
Specifically using a DAS28-CRP score, you know, you can get to an endpoint within 12 weeks, and usually sample sizes can range from, you know, 10 to 16 to 20 per arm in order to get you really powerful results versus placebo. The way that our and that's super practical compared to things like, you know, lupus and Sjögren's syndrome, where it's already tough to demonstrate efficacy, let alone then discriminate, you know, amongst doses. Our cohort three program, as you know, is 25 patients per arm, and so that is very practical study design. Once we have done that will establish the raw horsepower of the mechanism and will tell us more about how the dose can be administered.
From there, that's the jump-off point, if you will, to other opportunities in the space, and maybe Sanj can share, like, how we think.
It's very exciting. I mean, clearly, John Paolini's talked about this high concentration liquid formulation. We've got potential for subcutaneous dosing. The next steps will depend on the data and the level of differentiation. I think obviously we're very excited about it. You know, there is the opportunity, of course, of looking at what the RA does, and, you know, we've shown that we can commercialize drug. Our RAs, obviously, are very different beast and a very large indication. We've also shown that we can partner. We'll really look at the data, look at the potential for differentiation. We have said that really, you know, we're not necessarily gated, if you like, on the RA data before we start another rare indication. There's a few that we could consider for the CD40, CD154 mechanism.
we may well do that, but I think we have the real potential to have a best-in-class molecule here, certainly from what we've seen from our preclinical, the non-human primate study and the phase I study. Obviously, now we're looking forward to relatively near-term results. in our array, which even in itself is I think, hopefully, pans out the way we think it could be very exciting. A number of different jump-off points, we'll be measured, and we'll consider the data very carefully before we do anything.
Gordon, just in terms of your development strategy, you know, are there any particular autoimmune conditions or adjacencies that, you know, stand out as most subject to potential CD40 targeting? As we were discussing earlier, there are some competing assets that have shown, you know, some promise in other indications.
Yeah. I mean, I think the way we look at it is that anything that shows the power of this mechanism in different diseases is good for patients and it's good for the field. It actually allows us the opportunity, you know, somewhat de-risks, you know, our approach going forward. We can kinda see how these drugs have performed and, you know, some of the ways that we can adjust our own clinical trials in order to capitalize on that. I think you've, as you've mentioned, you've seen, you know, clinical trials in lupus. We've seen trials in Sjögren's, you know, recent data in multiple sclerosis. Exactly. I mean, these are all very exciting, because...
I think it speaks to the power of this mechanism and how it sits at a central place in autoimmune diseases. It's a real opportunity for us and for patients.
Okay, great. Maybe turning to other aspects of the pipeline. Sanj, you've referenced mavrilimumab, that earlier at the beginning of our discussion. Can you maybe, you know, update us on what the latest thinking is on the development strategy and/or partnering there, and how that's going?
Yeah, I mean, that was really a capital allocation decision to really focus on earlier-stage collaborative research agreements with academic centers around rare cardiovascular indications, mainly because of the synergies that we have within the cardiovascular commercial footprint, but also the relationships we've now developed with a number of the cardiologists. John's a cardiologist himself, but a number of the centers of excellence, they're doing some work with us. Nothing to report publicly at the moment, but we are looking forward to starting some of those studies in short order.
Okay, great. We're coming up on time here, so maybe I want to spend our remaining time with just thinking about the longer-term strategy and your capital allocation strategy to start with. You're obviously prioritizing investing in the launch as well as development of 404. Maybe could you speak to, you know, where you want to where you see maybe valuations for assets or business development opportunities, and just, you know, how you're thinking about the sort of state of the market when it comes to business development?
Yeah, I mean, we're very active. Obviously, we built the company through business development with the assets that we have, and we remain very much focused, and we've got a very strong business development activity going on. Looking at a number of different areas, obviously, most of our muscle memory is around immunology. Obviously, looking at cardiovascular because of our commercial footprint, but we've gone beyond that. We've got a portfolio of platforms, and we've said earlier-stage molecules. There's obviously, again, thanks to the successful commercial launch so far, strong focus looking at later-stage molecules within the cardiovascular immunological areas. You know, luckily, the sort of the reality has set in for a lot of companies, and the valuations, I think, are becoming more realistic. We just do a lot of diligence, and so the bar is incredibly high for us.
You know, we've obviously got a lot to do with ARCALYST still, as far as continuing to penetrate. CD40 is incredibly exciting, but we do believe there's enough bandwidth internally to continue that via business development, but it has to make biological sense, you know, rationale, as we've shown with the previous molecules.
Okay, great. We're almost up on time here, so I think we'll end it up on that note. My thanks to Kiniksa's management team here for joining us. Thank you very much.
Thanks, Paul.
Thanks, Paul.
Thank you.
See you.