Welcome, everyone, to 2024 Jefferies London Healthcare Conference. My name is Roger Song, one of the Senior Analysts covering Kiniksa in the U.S. It's my pleasure to introduce our next presenting company, Kiniksa. We have the full crew here: CEO Sanj, our CCO Ross, and CMO John. So welcome, gentlemen. Thanks, Roger. Thanks for having us. Good afternoon, everyone. My name's Sanj Patel. Very excited to be here and discuss our pipeline programs, and in particular, our lead asset, ARCALYST, which is now three and a half years into launch and doing rather well. I do want to start, however, with letting you know that we will be making forward-looking statements today that contain risks and uncertainties. A review of those statements and risk factors can be found in our SEC filings. So really happy to be here, Roger, and over to you for questions. Yeah, absolutely. So, Sanj, maybe we just kick this off right away, given the key focus, obviously, is ARCALYST, which you just said, off to a very good launch trajectory after a couple of years, launch sales, and then still growing rapidly. So, just off the 3Q earnings. So tell us what you see from the 3Q quarter- on- quarter, year- on- year growth, and then what is the nuance behind that in terms of the growth rate, kind of the sales metrics, inventory gross-to-net compliance, how that feeds into the overall sales number. Yeah, sure. Maybe I'll make some general comments, and then Ross obviously can go into much more detail. But look, overall, we're very excited. It's about three and a half years now into the launch, and we continue to see sequential growth with the ARCALYST franchise. And we're very happy. And that's no different, as we just saw in Q3 recently. It continues to see great prescriber growth. We're seeing high patient and physician demand and satisfaction, and also a very high rate of payer approval. And it's very much a sequential growth. We certainly are alluding to the fact that this year there was a very high Q2, which I think was largely driven by some strong compliance rates and gross-to-net. Q3, however, also was a very nice quarter for us with 74% year-on-year growth, but clearly not as high as Q2. I think that was very much expected. I think now we've come back to the sequential growth that we expected. We continue to drive that physician demand and that patient demand. Ross will talk about the fact that we've really expanded the sales force from the initial launch. We started off with around 29 sales reps that grew to about 50, and now, most recently, reported around 85. So great penetration. We're at about 11% penetration so far. That can tell you on the one hand, yes, there's so much more opportunity, we believe, to continue to penetrate into that market for this rare disease that's still got some unmet need. Yeah, thanks, Sanj, thanks, Roger. I think you said it well. Q3 was a good quarter for us. It was around $8.8 million in growth quarter- on- quarter, on top of the Q2, which was kind of an outsized bumper quarter, if you like, for around $24 million in growth, and I think we're pleased with the progress that we've made so far, but even more excited by the opportunity that we have ahead. As Sanj said, we're around 11% penetration into the 14,000 patient population. That's the patient population that has two or more recurrences, and there's also another patient group ahead of that, or earlier in the disease, on the first recurrence of recurrent pericarditis, which is an additional 26,000 patients as well, and the label of ARCALYST is very broad. We're utilized by physicians on the first recurrence, even though we focus very much on a promotional perspective for two occurrences or more. So we're pleased with the growth that we've had so far. And around the 11% opportunity shows that there's a significant headroom ahead for us to continue to grow into. Another metric that we share is that we now have more than 2,550 unique prescribers launched to date, and that's been growing at quite some clip quarter- on- quarter. In Q3, it grew by more than 250 versus Q2 of this year. So that's still growing at a really nice rate. So we feel that we're still very nascent within the launch. We're three and a half years in, but the opportunity that we have ahead of us is even greater. So we're excited about addressing that opportunity and reaching many, many more patients. Some of the other metrics that we have on the commercial side that we're very focused on is the payer approval rates, which Sanj mentioned, which is greater than 90%. So payers are really understanding the value proposition of this disease and the debilitating nature of the disease and how ARCALYST can really help return lives back to a far better state than they were suffering from this disease. So the payer approval rates continue to be very important. In Q3, another metric that grew was the duration. So the average duration of treatment grew from 26 months to around 27 months on average. And again, that's something that's been consistently growing since our launch as more patients get to the longer durations of therapy. And that's incredibly important because the duration of the disease, when you look at the natural history for patients that are suffering for two or more recurrences, is three years as a median. And still, a third of the patients are suffering from the disease out to five years, and a quarter of the patients out to eight years post the index episode. So we know that this is a disease which is multi-year in the vast majority of patients. And a big part of our promotional campaign is to make sure that physicians understand how to treat the disease to the natural history of the disease. So the fact that the duration of treatment of ARCALYST is growing also bodes well for the impacts that we're making to patients. Excellent. Yeah, totally agree. All the metrics, they are the key drivers for the ARCALYST continued growth. Maybe just zooming a little bit, when we build a model, I think that you'll give us the penetration rate for this population at any given time, I think, which is very helpful. Everyone tries to estimate what will be your peak penetration rate or whatever. So I think the fair question is, we don't know, right? So what's the peak going to look like? But what's the dynamic behind that? So how do you continue to drive the penetration? I understand this is partly the duration of the treatment, and then also the patient education, and obviously your commercial outreach. So how should we think about you can continue to increase the penetration rate at any given time? How are we going to see maybe some sign you are reaching the capacity of the ARCALYST can address the population at any moment? There's a number of factors, I'm sure. Ross will cover a few. I mean, first and foremost, it's all about execution. You have to be analytically minded as you do any launch and looking at all the key drivers, some of the ones that Ross and I just talked about, whether it be duration of therapy, compliance, making sure that you have the entire population covered, and making sure you have the reach to the physicians and the target audience. Ross talked about the fact that we've reached around 2,500 of the perhaps 11,000 target population. It's executing towards that all the time. As I said, you've got to be analytically driven. You've got to keep doing more of that. Clearly, over time, as I mentioned, we've expanded the sales force. That's really all about reach. We'll constantly look at the right, what is the right number for us to reach those physicians. There's other things. I'm sure John will talk about the RESONANCE registry, which we've actually looking at very, very closely just to make sure we understand what the dynamics are within the population. But clearly, duration has consistently increased. Where that will ultimately end up, we're not sure. If you look back to the RHAPSODY phase III pivotal trial, clearly, we had some really good markers there as to the longevity of the disease. It's a chronic flaring disease. And so we're seeing that patients are coming on. The number of repeat prescribers is very important. Another metric there, there's obviously patients that have had the first occurrence and physicians prescribing one time, but having prescribers prescribe again is very, very important. So certainly, it's about getting to that initial 14,000, but certainly the upside, if you like, could be getting to that 26,000. So the total population around 40,000. And that's what we do. We just constantly drive towards that metric. Yeah, that's absolutely right. And I think one way that we focus on growing the prescribers in the first place is creating awareness, and not just awareness of the disease and ARCALYST, but making sure physicians are at a stage where they are fully knowledgeable about how to prescribe ARCALYST as a preparation, which biologics are still reasonably new to many cardiologists. So some of that is understanding the process as well as the science and the rationale behind the approval that we have as the only FDA-approved therapy for recurrent pericarditis. And then on the repeat prescriber side, it's making sure that when they prescribe the first time, that they actually have a really good, smooth prescribing experience. And their patients get onto drug. They know how to do the approval process through the prior authorizations. All of that goes well. The patients get onto drug and then report back to the physician positivity around the clinical effect that they're seeing, which generally we hear from physicians that the effect is very similar to what we've seen in RHAPSODY as the phase III study, as well as RESONANCE in the real-world evidence registry, which is a very efficacious and safe drug to use within this disease space, and if physicians have a good positive experience, that then encourages them to look for the next patients and the next patients, so we've seen the prescriber rates, both of the total prescribers as well as the repeat prescribers, which are now about 25% of the total prescribing base, just continue to increase quarter- on- quarter, which is a good sign for us for the future. Awesome. So we have to say, Kiniksa, it's a biotech company, right? Relatively on the small scale. It's not common to see have a successful launch like ARCALYST. So that's the first thing we can acknowledge. And then just remind us how big the sales force team you have now. And then given you're trying to drive the continued growth, and how should we think about the future, the size of the team? Yeah, so right now, as Sanj said, we've grown the sales team a couple of times since our launch. We've been very thoughtful and mindful about what that looks like and should look like. And a big part of it goes to what I just said around making sure physicians have a very good prescribing experience and the patients get onto drug. And we educate throughout the whole process, as well as providing the services that we do through Kiniksa OneConnect. Kiniksa OneConnect is our patient service program in the U.S. to support patients and healthcare professionals through that process as well. So that's very important to us. We launched with, as Sanj said, around 30 sales representatives. We drove towards profitability for the franchise as quickly as possible. Ultimately, that was our strategy to launch effectively and make sure that we got to profitability as quickly as possible, which we did after three years on the market, sorry, three quarters on the market. That's been growing steadily ever since. We have expanded the field team a couple of times to make sure that we account for more prescribers, and because we do realize that patients right now are reasonably widely dispersed across the U.S. That extra field team has helped us just to get to more prescribers, as well as increasing the frequency on existing prescribers. Again, that's been a key part in growing our revenues and the profitability of the franchise since. But we will always be mindful of data and what that shows us, but we're always very careful in our investments, whether that's the field team or anywhere else across our commercialization or indeed our broader portfolio. Capital allocation is incredibly important to us and to invest where we really believe we're going to get the best return for patients and for the organization. So it's something that we will always monitor and keep an eye on and make the decisions that we believe are going to return the best value for the organization and patients. Yeah, for sure, you will keep the profitability of the ARCALYST franchise, but you also will try to grow your commercial team, try to drive the additional sales from the. Yeah, and we have to do obviously balancing looking at additional growth drivers for the organization. So in addition to ARCALYST, we do have our CD40 program, abiprubart. And that's obviously now we've announced that we're moved into a phase II study with Sjögren's now enrolling dosing patients. But clearly, as far as capital allocation is concerned, it's not just ARCALYST, but it's also just looking for additional real strong value drivers. And so we're very conscious of that. I'm sure we'll talk about abiprubart. And we're also looking at new assets as well and constantly doing business development. I mean, it's how the company was started just eight and a half years ago, really from scratch through business development. So we'll continue to do that and look for additional value drivers. Absolutely. Yeah, we're definitely going to talk about Abby in a moment. Maybe just zooming a little bit about the outreach part. So what's the split right now, academic versus community? Understanding RP seems to be wildly kind of dispersed. And then also in terms of the type of the physician, cardiologist versus rheumatologist. So how should we think about any kind of a white space you can continue to grow there? Yeah, so in terms of academic institution and splits in that regard, the way that we approach the commercialization is actually completely agnostic of academic or any other type of institution across the U.S. We spent a lot of time prior to launch and have fine-tuned it significantly since we launched this asset in recurrent pericarditis to really understand where the patient throughput is and which physicians are most likely to be seeing the future patients, understanding that this is a rare flaring disease. Sometimes patients go to multiple different cardiologists in the main, but I'll talk a little bit about rheumatologists as well. So we've got to be very flexible and have a great understanding of the marketplace, which is what we've been building over time to make sure that we're very effective around where we place our assets, particularly around the sales team. So we're really agnostic to whether it's an academic center or anything else. Historically, there have been a couple of key centers in the U.S. looking after recurrent pericarditis or having a key interest within pericardial diseases per se. We've certainly seen that grow over time, which we think is important and maybe a way of congregating more patients in expert centers that really understand the disease and potentially have the ability and experience to diagnose the disease and treat effectively earlier on in the disease. So we think that's important. That's certainly grown over time. And there's some external initiatives, for example, the American Heart Association, who has an initiative to try and build those types of centers over time. And in terms of cardiology and rheumatology splits, they're the two main customer groups for us. Around 70% of all ARCALYST prescribing is within cardiologists and the rest mainly rheumatology. So cardiologists generally look after this disease in the main, particularly on recurrent flares of the disease going back to the cardiologist that diagnosed them often in the first place. Rheumatologists also play a role within the disease management, sometimes either working with a cardiologist or if the cardiologist wants to rule out other underlying etiology of the disease, then a rheumatologist is sometimes kind of brought in or part of the workup for the patients. Excellent. And then I think, Sanj, you also mentioned earlier, you do see some sign expanding into the first recurrent, which is not necessarily your initial or the target, most targeted population for RP. So with this sign, so how you can capture or maximize the value, considering the commercial effort and then also maybe some additional strategy, you can expand that opportunity, further increase the sales. Yeah. Yeah, so well picked up. And it's a data point that we shared at the last earnings call for the Q3 earnings call, that when you look at all the patients that are currently prescribed ARCALYST for recurrent pericarditis, around 85% of the patients that are on ARCALYST are being treated on two or more recurrences. So that's that 14,000 patient population that I talked about at the beginning and is really our key target population. And that's where we're around 11% penetration, so around 85% of our patients, but with 11% penetration. So still some major headroom ahead in that two plus recurrence group. And then we shared that around 15% of the patients that are treated with ARCALYST in Q3 were on the first recurrence. Now, that's very important as well because physicians are really starting to see ARCALYST as the second line therapy behind NSAIDs and colchicine as first line therapy around the index episode of this disease. But when they go on to recurrences, ARCALYST is really now being seen as the second line treatment option. And we're seeing that across some of the real-world data that John could talk to as well around our RESONANCE publications that have also taken place. So we think that's very important. And I think it's good signs for the future, as well as physicians using it earlier on in the disease. They're acknowledging that the label, the FDA label for ARCALYST in recurrent pericarditis is very broad and is agnostic to the number of flares a patient has suffered. So seeing that grow in 15% of the ARCALYST patients is a promising sign. Excellent. Two more quick questions, and then we move on to the RB. So one is we are on the cusp of the new year. So when or if at all you will give us some 2025 guidance. And then the second quick question is now we focus on the U.S. for ARCALYST, and then how should we think about the ex-U.S.? Yeah, I mean, obviously, we're not going to tell you when we're going to give out guidance, but we. That's why it's a quick. But we look forward to continuing this sequential growth. Very exciting. I'm sure 2025 will be another exciting year if we've got anything to do with it. All right. right. Good. And then how about the ex-US? Ex-US, yeah, we're certainly looking to it, the opportunity for ARCALYST in recurrent pericarditis outside the U.S. We do have orphan designation in Europe for recurrent pericarditis and ARCALYST. And so we're looking at that very, very carefully. And as I said, we're very analytically driven. So we obviously have to look at what would it cost to invest versus the return. So at this point, we've not disclosed any actual plans, but we're certainly looking into it very carefully. Awesome. All right. So you are commercial stage, but you do have this pipeline in development and then also the BD opportunity. Let's talk about both. So maybe focus on the CD40 RB. So it is in phase II, Sjögren's, and then it's been enrolling for a while. So how do you see the enrollment pace here and then when we will get some updates for the enrollment and the data update? Yeah, maybe I'll give John the chance to say a few words. John Paolini, our Chief Medical Officer. Very exciting program. It's been enrolling for a wee while in Sjögren's disease, phase IIb. Right. So this is really building on the heels of the phase II program in rheumatoid arthritis. And that was a very important study because it established really the range of doses and the PK/PD relationships that are really the bedrock upon which we can build the rest of the program. As you mentioned, there's a lot of external proof of concept for this mechanism in a range of diseases. And we've selected Sjögren's disease as an important place to go where there is external proof of concept and there's no FDA-approved therapy. And so in that sense, we can take that strong biological rationale, but also importantly, build on the specific attributes of abiprubart. And that is that we have a high concentration liquid formulation that allows us to give reasonably large amounts of antibody at relatively convenient dosing intervals. We've tested not only weekly and biweekly, but even monthly dosing and shown relative comparability in terms of target engagement. That's what this study tests is biweekly versus monthly dosing versus placebo. I understand the high concentration liquid formulation is one of the key attributes or differentiation. Any other things you can say abiprubart is special compared to other CD40? Because we do have a few CD40. I would say they report some mixed data in the Sjögren's. How should we think about abiprubart can stand out in that landscape? I mean, ultimately, in this phase IIb study, this is where to basically plant the flag in the ground of what it is that abiprubart can do in this disease. And in that sense, we're encouraged by the way that we've designed the trial in order to maximize the signal and to see the magnitude of benefit that this could provide for patients, and so we have our work cut out for us to go forward, too, as Sanj said, to enroll like crazy so that we can get to the other side and show the data. All right. And I'm going to stick with the question. So it's been a while. So how should we think about the enrollment and then when should we have our estimate when we're going to see the data? And so what's your working assumption? Yeah. So of course, at this time, we have not disclosed any timelines related to the study. We have posted the study in ClinicalTrials.gov, which is an excellent place to go look for trial updates. One can also look to the literature for relative parallels, if you will, for other trials that have been run by other sponsors in this space. And I think that could allow one to think through about how long enrollment often might take. Then also keep in mind that this is, in terms of the duration of the study, it's 24 weeks to the primary efficacy endpoint, and then another 24 weeks in a long-term extension. And so in terms of the readout of data after enrollment concludes, there's still a substantial amount of treatment time and data processing to follow. But ClinicalTrials.gov is a great place to look. And then the initial data readout will be the primary endpoint, 24 weeks. Usually, that's the case. Yes. Got it. All right. Okay. So Kiniksa has a history or track record for the BD kind of activity. So how should we think about, given you're a profitable company, so how should we think about the BD activity there? We're cash flow positive on an annual basis. But I mean, we think about it very carefully. I mean, clearly, our bar is incredibly high for the assets that we've brought in. We're very pleased with what we've brought in. We've also actually done some outlicensing, too. We've actually sold one of our programs to Roche, Genentech, for a very large upfront money as well as royalties. So that's gone very well. So the bar's high. We continue to look. We're obviously looking mostly, I would say, in the immunology rare space, but we can look far and wide as well. Ultimately, it has to increase value for the company, which is what we'll do. So we'll be disciplined. If it's the right thing to do, we'll do it. Okay. Anything like a near term, mid term, long term? Maybe that's the. Watch the space. Okay. All right. Great. Thank you, gentlemen. Thank you, everyone, listening. And then we'll welcome to Jefferies. Thank you, Roger. Thanks for having us. Cheers.