Kiniksa Pharmaceuticals International, plc (KNSA) Earnings Call Transcript & Summary

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 e-mail us your questions, and I'll read them anonymously. But 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 couple of 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. Review of those statements are found in our SEC filings under risk factors. ARCALYST is off to a great start, 2 years now into launch of our first commercial product, which is IL-1 alpha and IL-1 beta indicated for recurrent pericarditis. Actually, the first and only approved FDA therapy for recurrent pericarditis, 2 years in, we've seen quite a successful launch. Ross will sure go into much more detail as far as that really how that launch has gone. We started off with around 29, 30 sales reps, have now increased that to 50 and seeing the early signs of that really helping us increase our revenues. In fact, actually, we've now guided to $200 million to $215 million for the year, which is up from our previous guidance, which is $190 million to $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 1 and cohort 2, and we're now enrolling in our cohort 3 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. So very exciting to really progress that program, and I'm sure John can go into the details of that, I'm happy to answer any questions on that. Beyond that CD40 program, we do have mavrilimumab, very excited about that, anti-GM-CSF molecule that's really been through Phase II studies showing positive results, in fact, both safety and efficacy both RA previously when AstraZeneca and MedImmune had it with ourselves. We took it through a Phase II GCA, again, saw positive results and also looked at in COVID. We've now re-pivoted and really focused now on rare cardiovascular indications, which really provides synergy with our existing cardiovascular sales force. I'm looking forward to progressing that. We did, last year, out-license our vixarelimab program, which is an OSMR beta-IL31 molecule. We were focused on PN but Genentech Roche, were very keen on really developing that in more fibrotic indications. So 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. So 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. So 1 of the 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. So -- which is going well. And you are 1 of that few companies who are able to raise guidance as early as Q1 here. So congratulations on that. So I guess, maybe a question 1 for either you or for Ross is where are you relative to plan in terms of penetrating your initially identified targeted accounts and prescribers.

Yes. Thanks, Paul. So maybe I'll make a start on that. I think probably 2 things. Firstly, how we're getting on penetrated in the [ actual total ] market, which, as you know, was previously in unmet market, we came as the first and only [ proved ] therapy in recurrent pericarditis and then maybe go on to the target base, the physicians and accounts and how we're doing around that. So 1 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, and we are focused on that 14,000 patients and those patients that have 2 or more recurrences. And that's our key target population we're going to, [ whereas ] the most overlaps with the RHAPSODY Phase III study, where we saw very compelling results and why we think that's the biggest call to action for physicians to really address patients with ARCALYST. So that 5% indicates ultimately that we are making good progress if you see from the revenue numbers. We landed $122.5 million throughout 2022. It's in that 5% penetration. But it also tells us that there's a big opportunity ahead of us to go after. So even though we're 2 years, just over 2 years into the launch now, we think we've got a very long runway ahead and is still fairly embryonic on the journey that we want to help in 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 cardiologist, some rheumatologists and some other smaller specialties as well but predominantly cardiologists who have prescribed ARCALYST in recurrent pericarditis, and about 23% of all of those are prescribed in multiple patients as well. So I think the growth there and that constant growth, and in fact, to 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 there is out there and how patients are across the U.S. being treated by many physicians. And we are starting to make good progress in addressing the awareness around recurrent pericarditis and indeed ARCALYST in making people comfortable and prescribing a biologic to address this condition.

Okay. Great. If we dig into some of the drivers of the launch, 1 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 even relative to the RHAPSODY study and patients who have also discontinued therapy are returning to therapy as well. So a couple of questions here are what is happening first on duration? And second, how would you characterize the market understanding or physician understanding? Is there a view that 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 2 things?

Yes. Maybe I'll make a couple of broad comments, and then feel free to jump in. So I think you're right. Duration has steadily increased since the launch. I think we initially predicted less than 12 months but we've seen now an average duration of around 20 months and still relatively early, as Ross said, in the launch about 2 years in. So hopefully, that will continue to develop, we have seen a steady increase in awareness of physicians. 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. And a lot of the information that we're able to provide is data from the registry or extension data from the initial RHAPSODY study has been very important, ensuring 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 3 years or more. So having a longer duration is important. But I think it's obviously a work in progress, a little bit early to sort of say exactly where it's going to end up but it certainly has been increasing over time. Is there anything to add?

Yes. I think you've outlined it very nicely. We -- just to give you the numbers behind that 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 trial and a stop and then about 45% of all those patients who have stopped ARCALYST therapy actually go back on to therapy, the vast majority within 8 weeks of stopping therapy. And then I guess the part that -- where the data is built is when the patients go back on to therapy, how long do they stay on therapy for. So that's kind of an evolving picture but [ because their ] data becomes more robust, we look forward to sharing more on that further down the line. But the average is about 20 months right now. And against the backdrop and the natural history being around 3 years for multiple recurrent patients but also going out about 1/3 of these patients still have disease at the 5-year time period as well. So we are really trying to educate physicians on the natural history of the disease, as well as how to treat with ARCALYST. And 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. And 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 1 reason being that corticosteroids were a way of treating difficult-to-treat patients. And if you treat it with corticosteroid 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. And I think that's what we're making good progress against, which is what the average treatment duration is starting to show us. But there's a lot more to be done.

And maybe, John, just kind of what the open-label extension data suggests on that front as maybe the longer-term potential. Could you maybe comment on that?

Sure. Absolutely. So the long-term extension data really provided the scientific foundations for understanding that recurrent pericarditis is a chronic disease that can last for years and that the flares are driven by IL-1. And so in that sense, it extended the median duration of treatment in the base study, which was 9 months, now out to almost 2 years with our longest duration out to 3 years. And so that gave clinicians really a solid data foundation for understanding how the drug was used. But importantly, I think a critical piece of data that was really eye-opening was that there was a decision milestone at -- after 18 months of treatment. And what it shows is that even in patients who have 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. And so that kind of hammered home the message that there's a 98% reduction of the risk of recurrence even beyond the 18-month time point.

Okay. Great. And maybe just a follow-up of that circling back to Ross, when patients come back on to therapy, is it because they've had an acute event or a recurrence? Is that the general driver that you're finding in terms of your data so far?

Yes. I think that's generally [indiscernible] data 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. So yes, generally, if you stop treatment too early and there's still underlying [ auto information ] going on with the patient and you're masking that and bringing back on symptomology. The good news is there is a wealth of data to show that if you treat patients again, send them back on to ARCALYST therapy, then they get back -- they get the disease back under control rapidly as with the first time around. But ultimately, we want to try to educate for that longevity of treatment and avoid patients going through those future exacerbations and flares.

Okay. Great. Maybe just speaking to your sales force interactions and just kind of what it takes to get -- 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? Maybe what is sort of the key barrier to physician prescribing or adoption potentially, are they looking for other drugs in your -- in the bag to come and sort of a portfolio approach in terms of taking up ARCALYST? Or is it more single focus on RP here.

Yes. Maybe I'll start. I mean I suppose initially, it's focused on RP. I mean historically, cardiologists have not been so used to prescribing biologics. We've got a split of around roughly 75 to 25 cardiologists versus rheumatologists, rheumatology certainly are more attuned to prescribing biologics. And so our effort has really been, as I said earlier, increased the awareness but also introduce the fact that this is a very important therapy for these patients that have gone without therapy for so long. And the RHAPSODY data has been so compelling. It's really been a great tool for us to be convinced that this is the right thing to do. So again, these centers of excellence, I think, are very important and I would actually set up a lot of referral networks via some of the initial centers of excellence that have helped to really educate the rest of the physicians, so 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. We are looking at synergies, hence, we're looking at rare cardiovascular indications with mavrilimumab but also open to actually, as you say, adding to the bag the additional business development, ideally within cardiovascular or immunological areas. So we're looking at a number of different areas to sort of increase that commercial footprint. Yes.

Yes, I've got much more to add to that other than we remain focused in terms of our targeted approach with our field team. We increased our field team to around 50 as Sanj said at the beginning in order to increase our breadth of physicians so we can get to but also increase the frequency. So to your point around the multiple calls, we do have a lot to try and achieve within our sales scores 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 index episode, and also around ARCALYST. And 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. So 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. And bear in mind it's a rare flaring disease. So it is a process but that's 1 reason why we increased the size of the field team. And 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 -- and biologics have been -- among cardiologists have been largely limited to PCSK9, which were always challenging to get payer approvals for in that business historically. Maybe in terms of other sort of market dynamics, I guess, how would you characterize brand awareness of ARCALYST at this point? You mentioned earlier that 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. But I guess how would you characterize market awareness of a treatment option being available for RP at this point?

Yes, I think it's been growing substantially since the time of launch and having the first only approved therapy in an indication automatically gets 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. So I think we're making good progress against that, as you see from all the numbers. But yes, there is a huge amount of work to be done there. And as Sanj alluded to, 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 to have referral pathways for pericardial diseases. But as the interest grows and more [ sensors ] grow and kind of create referral networks and so on, I think that can only be good for everyone in the -- all the stakeholders involved.

I mean I think you can say that 5% penetration in 2 ways, right, certainly 2 years and 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.

Okay. 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.

Yes. It's a great question. We haven't shared exactly what the percentage split is between existing patients, again refills and new patients coming in. But you can take from the fact that we've been growing steadily quarter-on-quarter to 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 there is a high degree of existing patients that they're getting that refills on a monthly basis. Also bear in mind that the compliance is very high, very, very strong within this disease, and we had a lot of support to patients through patients and services and adherence programs and so on associated with that. So 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. But of course, the more patients you have on therapy, and this is not a lifelong condition. So patients do drop off every single month or quarter as well. So the new patients that we enroll into our services and programs and get a prescription for ARCALYST that come on to therapy for the first time. Obviously, you have to outpace those patients that drop off in order to kind of keep getting that, [ great. ] And 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, 1 question, I guess, at this point into your launch for either Sanj or Ross is just where are any payer gaps remaining, any major plans or anything that is still continuing to push back and just say RP is not something that we think is real despite the approval of ARCALYST and just sort of what's left in terms of working on the payer side.

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.

Yes, absolutely, right. It's been greater than 90% every single quarter since launch. And that's really across the board, whether it's commercial or Medicare, Medicaid as well. So 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. And I think the very compelling results coming out of RHAPSODY certainly help with that.

And the expansion data.

Great. One of the questions we get from investors and clients is just understanding who is being treated here in terms of the early stages of the launch? Are you just sort of getting the low-hanging fruit. And if you were to sort of characterize the patients at this point, are they mostly the patients with severe disease. And if not or if that is the case, 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, post approval and in the early stages of the launch, you do get some of the low-hanging fruit as you say, some of the most severe patients, they've been waiting for therapy. But I think even as we've sort of expanded our reach across the country, we found that we are getting new areas, new centers of excellence, where you're still funding very severe patients. It's a general mix without a doubt. Yes.

Yes, absolutely. The majority of patients prescribed ARCALYST for recurrent pericarditis are within the 14,000 target population that we are focused on from a field team perspective and targeting physicians that have the highest throughput of those 14,000 patients. So the vast majority are there, we do have some patients that are also higher up or earlier on in the disease course, if you like, that are on their first recurrence. And I guess that alludes to the broad label that we have from the FDA, which does not stipulate the number of recurrences that a patient must have had previously. So that allows the freedom for physicians to really pick and choose where they believe ARCALYST can really help their patients to a lesser extent those patients there.

I think maybe you are elucidating some of the information we've got from the extension studies, I think are very important in helping educate physicians as to why they continue to see these patients.

The extension data are useful there as well as the actual registry, which is going on now, which is resonance. If you think about, it's a network, if you will, of centers across the country, when it started, the registry was -- there's 6 of the centers that were in the clinical trial, and now it's expanded out to '22. And so that tells you that you have centers that are really paying attention to pericardial disease. And then within that, 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 depth of the data set that Ross is dealing with. But at the same time, it's a representative data set from a research perspective. And again, it shows you many of the trends that Ross has mentioned, which is the utilization across the spectrum of disease as well as kind of how patients are coming on to ARCALYST therapy from not only corticosteroids or just kind of the old paradigm. But now this new paradigm of coming directly from NSAIDS and colchicine skipping the steroid step, and going directly into ARCALYST as the approved therapy. I mean I think that's kind of what the data are now showing that, of course, has 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. But as you think about patients who have maybe just had their first reoccurrence or are gone a long time between recurrences, what is that additional sort of patient pool look like in terms of helping us size up the opportunity here?

Yes. So that additional patient pool would be an additional 26,000 patients on top of the 14,000 the multiple recurrences, another 26,000 just in any given year or just on their first recurrence of pericarditis. So the totality being 40,000 population there. So that would be what would be covered under the label that we have in the U.S.

Maybe turning to the pipeline, and maybe I'll ask John this question here. Can you maybe just talk about maybe the enrollment status. Sanj mentioned a little bit on cohorts 1 and 2 being fully enrolled for KPL-404 and just kind of where you are with regard to cohort 3 and your RA program.

We're very excited about the KPL-404 as you might imagine, a very strong asset, blocking CD40-CD154 interaction, lots of external proof-of-concept that has preceded that. It gives us a lot of confidence in the mechanism. And so what we're excited about with KPL-404 is moving beyond the Phase I single-dose program now into the multiple ascending dose program having gone through those first 2 cohorts to kind of establish the PK parameters and now really focusing on demonstrating the efficacy of KPL-404 in rheumatoid arthritis. And Cohort 3 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-404s that you can deliver a large amount of drugs subcutaneously. And we're testing a 5-milligram per kilo, very practical dose that can be administered either biweekly or weekly compared to placebo. It's a 12-week endpoint, which is relatively brief, in immunologic studies. And so that program is progressing, and we anticipate data in the first half of 2024.

Okay. Great. So for people who may not be familiar with the CD40 landscape, could you maybe just highlight for us what are sort of the differences in terms of the, that differences that 404 has relative to some of the other drugs that have been out there in the category because we have seen some other data from competing assets that use a similar approach and maybe just 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, so the CD40 is on B cells and antigen-presenting cells, CD40 ligand or CD154 is on T cells, and different assets in the space have targeted that differently. So for example, you might know of Horizon's molecule, for example, which is Dazodalibep, which is blocking CD40 ligand. On the other side, you have something like iscalimab, which is blocking CD40 directly. And so if you look at 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. And if you think about something like Dazodalibep, powerful efficacy but requires large amounts of protein to be delivered intravenously at relatively frequent intervals. So while you get the efficacy, there's the convenience factor. On the other hand, we have iscalimab, which has done well in covering a range of different indications and has done well as an intravenous dose but perhaps has done perhaps a little bit less well so far with subcutaneous dosing. And so I think the way we've developed KPL-404 in terms of the program is to focus down on having a high concentration liquid formulations for practical and administration. And our data showed that the 5-milligram per kilo subcu dose was roughly equivalent to the 3-milligram per kilo IV dose, which then opens the door to being able to attack chronic diseases in a way that's good for patients. So more to come, of course, with the data.

Great. So RA is kind of a well-known landscape to the investment community. And just as you think about your study here and what you're trying to show. Could you maybe highlight for us how you're thinking about what the relevant metrics are in terms of the RA landscape, why you think of focusing on 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. But yes, in terms of why we made this choice for Phase II, rheumatoid arthritis, as you said, a very well-characterized disease. One of the advantages of it is that 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 end points in a relatively short period of time with a relatively small number of patients, specifically using a DAS28-CRP score, you can get to an endpoint within 12 weeks, and usually sample sizes can range from 10 to 16 to 20 per arm in order to get you really powerful results versus placebo. And so the way that our -- and that's super practical compared to things like lupus, androgen et cetera where it's already tough to demonstrate efficacy let alone, then discriminate amongst doses. And so our cohort 3 programs, as you know, is 25 patients per arm, and so that is very practical study design. Once we have done that, that will establish the raw horsepower of the mechanism and will tell us more about how the dose can be administered. But then 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're thinking.

It's very exciting. I mean clearly, John has talked about this high concentration liquid formulation that 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. There is the opportunity, of course, of looking at what the RA does, and we've shown that we can commercialize drug or obviously a very different beast and a very large indication. We've also shown that we can partner. So we really look at the data, look at the potential differentiation. We have said that really we're not necessarily gated, if you like, on the RA data before we start another rare education. There's a few that we can 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 nonhuman primate study and the Phase I study. Obviously, now we're looking forward to relatively near-term results in RA, which even in itself if I think, hopefully, it pans out the way we think it could be very exciting. A number of different jump-off points but will be measured and we'll consider the data very carefully before we do anything.

Right. Just in terms of your development strategy, are there any particular autoimmune conditions or adjacencies that stand out as most subject to potential CD40 targeting. As you were discussing earlier, there are some competing assets that have shown some promise in other indications.

Yes. So 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. And it actually allows us the opportunity -- somewhat derisks our approach going forward. So we can kind of see how these drugs have performed and some of the ways that we can adjust our own clinical trials in order to capitalize on that. And I think you've -- as you've mentioned, you've seen clinical trials in lupus. We've seen trials in Sjogren's, recent data in multiple sclerosis exactly. I mean these are all very exciting because, and I think it speaks to the power of this mechanism and how it sits at a central place in autoimmune diseases. So 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 earlier at the beginning of our discussion. Can you maybe update us on what the latest thinking is on the development strategy and or partnering there and how that's going?

Yes. I mean it was really a capital allocation decision to really focus on earlier stage [indiscernible] 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 is 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. 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. But then maybe could you speak to where you want to -- where you see maybe valuations for assets or business development opportunities and just how you're thinking about the sort of state of the market when it comes to business development.

Yes. 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 [ Dazodalibep ] 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 lots of portfolio, our platforms, and we has had early-stage molecules, is obviously, again, thanks to the successful commercial launch so far, strong focus looking at later-stage molecules within the cardiovascular immunological areas, luckily, the sort of -- the reality is set in for a lot of companies and the valuations, I think, are becoming more realistic but we just do a lot of diligence. And so the bar is incredibly high for us. 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 rationale, as we've shown over 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. Cheers.