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

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. I guess my immediate left is CEO, Sanj Patel; to his left Ross Moat, with 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.

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. A review of those statements and risk factors are 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.

Okay. Sure. So maybe starting with ARCALYST here, if we could. The 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 what the evolution and patient behavior has been like since the launch? And maybe what you can comment on with regard to the mix of repeat prescribers versus first-time prescribers? Maybe I'll start there.

Yes. Maybe, Ross, I'll start with 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, ARCALYST has now been approved for just over 3 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 full year 2024 revenue of $370 million to $390 million. And 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. Obviously, it's still 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 trajectory.

Absolutely right. Maybe I can add to that and say, indeed, we're pleased with 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, so the patients we have on, I guess what I can say is that 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 touch points with the patients that we look after with ARCALYST through Kiniksa OneConnect, 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 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 on to therapy. So to your point around repeat prescribers, we see the prescriber base increase substantially quarter-on-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 prescribe for 2 or more recurrent pericarditis patients 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 Sanj kind of alluded to, we're pleased how things are going, but we're never complacent, so 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.

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

Yes. 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 2 or more recurrences. Certainly, we've done a lot of things since the launch. 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 that are 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. We do have things like Kiniksa OneConnect, 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.

Yes, exactly right. So we've grown the field team since the time of launch. We're up to around 85 representatives as 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 health care professionals across the U.S. with our around 85 field team. We also, obviously, have the MSL team, a payer team as well. And 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 through ARCALYST actually been 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, 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.

Okay. I want to actually ask a question we get from investors a lot, which is like kind of what duration could maybe sort of ultimately end up 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 very long adherence and compliance in the clinical trial setting. And so maybe just in terms of driving the sales growth and just sort of the stickiness of patients, 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 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?

Ultimately, this is a chronic flaring disease. And 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 6 to 9 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 with that so far helps. Compliance has been very strong, above 85% to date. So it remains to be seen, but it certainly is a chronic flare in disease, and there is the opportunity, we believe, of a longer duration, but time will tell.

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've previously for recurrent pericarditis, which was short-term treatments and 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 a shorter time period as possible. Where we're really changing the paradigm for the treatment, so we're educating physicians around the natural history of the disease, which is for recurrent pericarditis for patients that have 2 or more recurrences. They suffer from the disease in the median of 3 years, and around 1/3 of those patients still suffer from the disease at 5 years out. So as Sanj said, this is a chronic disease that needs to be treated throughout the course of the disease. And 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 6 to 9 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, this is something we're continuing 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, patients need to be treated throughout the course of it.

Great. In terms of how patients come on to the drug, do you see much experience in terms of patients when they have a reoccurrence coming into, let's say, the ER or something like that? Is it used in sort of 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 or after a hospital visit, whatever the case may be? And just how do you think about this maybe being in the ER setting for patients who have acute recurrence.

Maybe I'll start with some clinical trial data and then pass over to Ross for the real-world experience. So 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, a maintenance therapy to prevent recurrence. And so we know for a fact that from the clinical trials data in patients that were actively flaring, time to treatment response is 5 days. On the other hand, what we know is that if you treat patients over the long course, continued treatment resulted in continued treatment response. And so that really 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 not flare.

Thank you. So we actually -- of all the patients that come in to 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% are not in a flare. So I think that speaks to how broad our label is in recurrent pericarditis where it's for both the treatment and the prevention of recurrent pericarditis and subsequent episodes and the reduction of risk of further episode. So we see that utility across the spectrum of patients suffering from the disease. In terms of the -- often when patients are on their index episode, they go into ER and usually 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 ER less and less and they go to visit a cardiologist's office and that's where a lot of the prescribing -- most of our prescribing for ARCALYST is from cardiologists, but also from rheumatologists as well.

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

I mean it's a variety of things, very often, it also could be other complications or other diseases that are actually interrupting and people 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, unless you don't know have anything to add to that, John?

Yes. So in terms of patients coming off of therapy, I mean, as Ross mentioned, it's a chronic disease treatment, 3 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, 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, 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, cessation of therapy or suspension of therapy and letting the drug wash out to see if the disease is still present 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 that if you stop the disease -- 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 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 that contributes to some of that number. And then maybe there are some other factors as well.

Yes, that's right. I think sometimes it's when patients stop and come back on to therapy. As 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 and other underlying diseases or someone is going in for surgery or has some infections and so on. There are other reasons why you can hit the compliance rate. But overall, we're very pleased with our compliance rate. It's greater than 85%. It's a robust compliance rates. As we mentioned earlier, we have Kiniksa OneConnect, our patient service program. We had some very [Technical Difficulty] with our patients. And as part of that is a compliance and adherence program that we run with patients as well to support them all the way throughout the 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.

Okay. your launch to date has been sort of controlled and focused and targeted to select sort of prescriber base, but there is also a larger tranche of patients who are not necessarily being targeted, which is those pericarditis patients with a first recurrence once you reach sort of your target threshold population of sort of the first tranche of centers and patients that you've been focusing in. So how do you or when do 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.

I mean the time is now. We've been thinking of it for a while. I mean we have said recently, we've reached around 2,000-plus prescribers so far. The bulk of those 14,000 those have two or more recurrences, but there are a good valid -- they're on their first currencies, as Ross mentioned earlier, the label is so broad that allows the treatment of recurrent pericarditis whether on their first or whether on their second or third or fourth, et cetera. 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 having an outreach to focus 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. So there's certainly an upside potential there without a doubt.

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

Yes. I mean, as far as [Technical Difficulty], as we know, is the first and only 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. As far as ultimately where it goes, it 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 that at 9%. We hopefully, obviously, plan to increase that significantly going forward with ARCALYST. Beyond that, I mean, again, it remains to be seen as far as where it goes in the future. 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 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 Abiprubart and the applications there. We announced that we're now moving into a Phase IIb in Sjogren'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 on top of that, it allows us to look at potential other areas of growth within the clinical field as well. 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 8 years ago. So that cash position allows us to be extremely flexible but also invest in the future and invest in growth.

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

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

Maybe turning to the pipeline Sanj has brought up and talking about Abiprubart. I guess maybe can you just remind us in terms of what updates you'll provide with regard to your Sjogren's study initiation and just sort of what pipeline or enrollment updates maybe to start there with the Phase II trial and what sort of news flow we can anticipate over the next, call it, 12 to 18 months, give or take. John?

So as Sanj mentioned, we're pleased to announce that we'll be starting a Phase IIb study in Sjogren'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. ClinicalTrials.gov is a great place to go routinely for updates about trial enrollment at this point. We've announced that our intention to start and watch this space more to come about the time line of recruitment and ultimately the data.

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

Sure. I mean it's important to point out that so far, there are no approved products in Sjogren's disease. And so the regulatory path is still 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 in a particular score called the ESSDAI, 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 we will 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 2 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 derisked 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 target derisk, 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 for the data collection.

Great. Could you maybe speak about how you view the potential differentiation, or what's unique, I guess, about Abiprubart versus some of the other CD40 assets that are out there that have put out clinical data in Sjogren's, whether it's iscalimab or dostarlimab 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?

Yes. 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 -- and for example, the competitors that are in the space, they have biweekly subcu 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 allows us to anchor on a biweekly dose, but then also to even test whether taking that subcutaneous dosing to a monthly dosing interval is efficacious against placebo. And so in that sense, this study really is designed to show not only the core efficacy of the asset, but also a potential for differentiation in terms of convenience of dosing in a way that's practical for patients.

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

Yes. 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 II study. And that, I think, gives us a lot of hope and promise that there is potential there in broad indications such as RA. Now 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. We'll continue the program right now within Sjogren's. We are looking at other indications, whether they be in the rheumatology space or the neurology space. But certainly, RA is not loss to us, there's potential there, and we may well consider a partnership at some point going forward.

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

I mean we're going to 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. You mentioned that are very broad, and they have an awful lot of potential and that could potentially allow more than 1 or 2 entrants, and being a fast follower is something that we're certainly open to, but in the end again, it will depend on the data. We're certainly going to start this Sjogren's study imminently. And then beyond that, we'll look forward to elucidating next steps at the program. But certainly, rheumatology, neurology, as you say, a real strong areas that we could focus on for Abiprubart.

Great. I'll turn maybe a little bit towards some corporate questions and just sort of BD. I think 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've had proof of concept like mavri and just sort of where next steps might be for that program? And just maybe if you could provide an update on just how you're thinking about BD there for new programs.

Yes. Just to remind, mavrilimumab is a monoclonal antibody anti-GM-CSF that we took to the Phase IIb studies in giant cell arthritis. It's shown positive data there as well as safety in that indication and previously in RA. Yes, we still think there's a lot of 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 and 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.

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

Yes. So we're cash flow positive on an annual basis. Cash reserves are around $213 million, $214 million. 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 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 were very much focused on creating value in the near, mid and long term. So that's what's going to guide us going forward. The beauty about the pipeline, it is somewhat 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. And as always, as we've shown over the last 16 years between 2 companies that many of us have worked on together, we've shown that we can be extremely good stewards of capital, and we're extremely economically responsible. And if we do a BD deal, it will be the right one.

Okay. I want to ask maybe in our time remaining, you have assets in the clinic in terms of Abiprubart and a commercial stage asset with ARCALYST. But in terms of earlier-stage development, just kind of -- this is something, I think, with your story that doesn't get a lot of airtime. I'm just curious 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 clinic-ready or something like that. I'm just kind of -- is that something you want to start talking a little bit more about? Should we expect more INDs coming out in the next 1 to 2 years? And just is that something you feel like is something that needs to be prioritized just to think about adding another leg to the Kiniksa story.

Yes, absolutely. I mean we do have scientists. We do have an early-stage group, without a doubt, our own laboratory as well as our 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 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 the space. I know our intention is to be a leader in various franchises, whether that's the IL-1, whether that's in CD40 mechanisms. We intend to make a lot of value and help some other patients.

Great. In our closing minute or 2 here, maybe Sanj to close out, maybe as you think about sort of the investment case here for Kiniksa over the next 1 to 2 years, maybe what would you highlight as maybe sort of the most underappreciated or missed opportunity in terms of the company's potential.

I think it's all of the above. I think the launch to ARCALYST has gone incredibly well. I think that's taken people way back a bit by surprise. But obviously, as Ross and I talked about, we expect to continue that growth. That's definitely an undepreciated area. Abiprubart, think if you look at the Phase II data generated today, incredibly compelling, very excited about the Sjogren's study and looking into potentially other areas and business development. Obviously, as I said, we've created this company from scratch, blank piece of paper about 8 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.

Great. 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.

Thank you, Paul.