Good morning. Welcome to the BofA SMID Cap Biotech Conference. My name is Geoff Meacham. I'm the senior biopharma analyst. Welcome to the morning sessions. We're thrilled to have with us Kiniksa. Speaking out behalf of Kiniksa is CEO Sanj K. Patel. Sanj, how are you? I'm jolly well. How are you, Geoff? Good. Good to see your face. Next year, maybe we'll do this in person. Let's just kick it off real quick. I know you're an efficient guy, let's just go. Give us a 30,000-foot view here of, you know, a quick background, and then get right into some questions on ARCALYST or rilonacept. Absolutely. Again, thanks for having me today, Geoff. Please do note that I will be making forward-looking statements here that are subject to risks and uncertainties. Review of those statements are found in our SEC filings. With me on the call today are Mark Ragosa, who's our chief financial officer. Eben Tessari, who's our chief operating officer. John Paolini, our chief medical officer, and we have Ross Moat, who's our chief commercial officer. Obviously, the whole team is here. We're very excited. You know, we've had a great start with our launch in ARCALYST. 20 months in now, we've seen solid, steady, progressive growth with our first approved and commercialized product for recurrent pericarditis. That's obviously very exciting, and I'm sure Ross will give you a bit of more of an overview and how that's going and what we plan to see. Beyond that, we're also really excited about the portfolio. You know, obviously this is a company that got started only about seven years ago, and since that time now, additionally to having the commercialized products, we've also got the pipeline in full view. We're very excited about KPL-404. That's our CD40 program, which interrupts the signaling between CD40 and CD154. We took that in via an acquisition of a company based in Massachusetts called Primatope Therapeutics, and very quickly took that into a first in human study. Now we're in a phase II study in rheumatoid arthritis and could eventually lead to a lot of optionality for other rare indications too. An awful lot going on. We also have mavrilimumab, and we continue to be very active in business development. Very exciting time for Kiniksa, Geoff, and thanks for being here and look forward to the questions. Yeah. Yeah, I Yeah, I know. Of course. Yeah. let's talk a little bit about the, you know, the launch in recurrent pericarditis. give us maybe a status update on, you know, today with respect to payer coverage, you know, prescriber engagement. I know you guys recently expanded your field team. Kind of what are their metrics looking to next year that you think, you know, we should be, we should be looking to outside o f obviously guiding? Yeah, of course. Ross, do you wanna start and I can jump in or Eben, can you jump in as well? I'm very happy to. Hi, Geoff, thanks a lot for the question. So far we're delighted with the launch product. Things are going very well. What we've seen since the time of launch is a good, steady, you know, quarter-on-quarter growth and, you know, really feeling that ARCALYST has been well received by physicians, payers and ultimately patients who are suffering from the rare debilitating disease. Maybe if I touch quickly upon, you know, kind of payer coverage and prescriber engagement, and I go and talk about the field team expansion that we're currently going through as well. Firstly for payer coverage. Of course the key players now all have ARCALYST coverage policies in place. You know, we're kind of 20 months or so out from our launch. What we've seen right since the early stages of launch, about every single quarter, is a greater than 90% approval rate on all of the completed cases. That's really across all of the different payer mixes as well. We've been very pleased with the payer appreciation of ARCALYST and the value proposition that we think we're coming to the market with to help patients with this rare flaring and debilitating disease. In terms of prescriber engagement, again, feel like things are going very well, acknowledging that there is a level of education in both recurrent pericarditis and of ARCALYST. Then just, you know, making people familiar and comfortable with prescribing ARCALYST as a biologic. Biologics are reasonably new still for cardiologists to start to prescribe. There's a level of education that's required there. Having said that, we think we're making really good progress here. We've added more than 100 individual doctors every single quarter since the time of launch. At the end of Q3, we had more than 650 individual unique prescribers of ARCALYST in recurrent pericarditis, and also seeing a growing base of those that are becoming repeat prescribers as well. You know, around 22% of the totality. Acknowledging that that's also off a growing base of course. The absolute number as well as the percentage has been growing there. Really importantly for us is the feedback from patients as well and the physicians are getting directly from patients reporting very high satisfaction ratings with back to their physicians. Which I think is very important for physicians to hear that from their patients around the clinical outcomes, as well as seeing that the drug is being approved, generally speaking from the payers and that the affordability is there for patients. They're getting onto drug, having good outcomes, which leads to, you know, a propensity to prescribe for the future as when they see more patients. On the field, expansion side of things, really, you know, aligned with our approach. We felt that this would be a good step to take to grow our field team. As you know, we're always very measured, very stepwise, data-driven organization. You know, we launched with a fairly lean, very highly targeted field team. Our intention was to get a good launch under our belt and drive towards profitability for the collaboration that we have as quickly as possible. We did that within about 3 quarters. Now we're at a situation of kind of really taking the learnings from launch. You understand that of course, we did a lot of market research to understand the marketplace prior to launch. What we've been seeing is your patients are very widely dispersed across the U.S. There's a limited number of key centers that are looking after recurrent pericarditis patients. They present to many different physicians all across the U.S. That along with the learnings of, you know, for cardiologists, it takes some steps to make them really comfortable and familiar with ARCALYST and start prescribing ARCALYST as well. We really felt that the expansion of the field team would help us to enable greater penetration, greater coverage, frequency with the target physicians, so we maintain a very highly targeted approach. We've gone from around 30 representatives up to about 50. We feel like with that expanded field team, we can address around 70% of the recurrent pericarditis, the multiple relapsing recurrent pericarditis population. That will help us just to generate the greater frequency and coverage, keep us on a good trajectory. Yep. Just to follow up on that, you know, two quick questions. One, maybe give us a sense for, you know, the geographic kind of nuances if there are any. The second thing is when you think about duration of therapy, you know, is that in line with persistent rates? Is what you're seeing today in the real world, in line with what you had expected, you know, looking to the, you know, to the initial pivotal studies? Yeah. Thanks. Maybe I'll make a start on that then and then maybe hand over to John to talk around particularly the long-term extension data, which is reasonably new. I can come back and talk about how that may translate into the, the commercial setting. I mean, maybe to start with the first part of your question, which is around the geographic distribution of patients or any differences we see. I mean, really, we just see that patients are very widely spread across the U.S. You know, historically as I mentioned, there are just not very many key centers that are really looking after pericardial diseases. There are a few, but they're far between. You know, that means that patients unfortunately are kind of really spread, and then we need to try to meet that in a very targeted, you know, robust way, and that's why we're focusing on the field team. We also, because of that geographic distribution, acknowledge that, digital marketing, and those types of strategies are very important to us as well. We've been very active around education through different congresses, speaker meetings, webinars, patient webinars, healthcare professional webinars, and, you know, building a database of known pericardial patients that, you know, we can then opt into our system, so we can communicate with those patients very tailored to where they are within their journey with recurrent pericarditis as well. We have multiple different ways of trying to, you know, very efficiently reach a kind of dispersed population. John, maybe I'll hand over to you for the duration and the long-term extension comments, then I'll come back. Sure. Happy to. Good morning, Geoff. Nice to see you again. Yeah, I'll touch on the long-term extension data. Obviously, we're very pleased with the data that were presented at the AHA last month. There are really two key takeaways from that. You know, first, from a natural history perspective, it shows that recurrent pericarditis is a chronic autoinflammatory disease, which is driven by IL-1. Second, from a treatment perspective or management perspective, that ARCALYST treatment beyond 18 months resulted in continued treatment response. Just to put the data into a little bit of context, you know, patients entered the trial on average about two and a half years into their disease. The median duration of continuous rilonacept therapy after that point was 27 months, with a maximum of 35 months of follow-up on treatment in the trial. The new data that were presented at the AHA, first, that the on-treatment annualized incidence of pericarditis recurrence during the trial while patients were on rilonacept treatment up to this 18-month decision milestone was 0.04 events per patient year. That's two orders of magnitude lower than the 4.4 events per patient year that these patients were experiencing in that two-and-a-half-year span of their disease prior to entry into the trial, while on just standard therapies. Subsequently, at the 18-month decision milestone, those patients who continued to receive rilonacept after that point experienced still a 98% reduction in risk of recurrent pericarditis events. That's a hazard ratio of 0.02 with a p < 0.0001. Compared to those who chose to suspend therapy at that time, where those patients had a 75% recurrence rate. There was only one pericarditis recurrence which took place in patients continuing on rilonacept, and that actually again occurred in the setting of a treatment interruption of about a month. Importantly, that patient subsequently went back under control once they reinitiated therapy. When we pull that all together and realizing that it is critical to distinguish data that are generated in clinical trial setting, you know, from those that, you know, come out of the real world, it still speaks to kind of the scientific and medical underpinnings. First, that these data from RHAPSODY are consistent. Pericarditis is a chronic disease. It's mediated by IL-1. It's characterized by multiple recurrences if incompletely treated, and it can last for several years. From a treatment perspective, it shows that the consequences of premature interruption or suspension of therapy really results in unmasking of the underlying autoinflammation, and that leads to pericarditis recurrence. Finally, we learned that re-initiation of rilonacept resulted in resolution of pericarditis recurrence, and that's an important piece of information in chronic biologics therapy, as you know. That's the totality of the new data set, now I'll turn it over to Ross to talk about how that translates into the commercial side. Yeah. Thank you. Thank you, John. Just some of the things that we're focused on as an organization now is also, you know, disseminating those data from the long-term extension study through either our sales team, through the commercial capacity, through our medical team in the field, and obviously congresses and other routes to get this data out there as well, which we think is very important and accretive to the original study and the original portion of the study that we gained the label on from the FDA. What we're seeing in the commercial setting up until the end of Q3 in terms of duration of therapy is that the average duration has been approximately 12 months for the commercial patients. Acknowledging as well that, you know, many physicians will see the 12-month time period as a time to pause, relook at the patient. Often it ties in with the reevaluation or revalidation of the payer approval for the patients as well. That's a moment in time where they will pause to relook and think. That's what we've seen so far. More recently, we've also started to see that as of those patients who discontinued ARCALYST therapy, actually about 35% of those patients came back on to commercial ARCALYST therapy after having stopped. Often those patients came back on within around a eight-week time period, which again is, you know, in validation with what we saw during the clinical studies of patients that had stopped and regained symptomology and started back on therapy. You know, that's an important insight. It may be, you know, the case that the duration of therapy may be longer than the 12 months that we're seeing at the moment. Ultimately, we just need to wait for those data to build and become more robust over time so we learn from that. Ultimately, you know, our goal is to make sure that patients are treated throughout the duration of their disease and do not have to stop therapy, you know, experience symptomology again and go back onto therapy. It's a wonderful safety net to have. We want patients to be treated throughout the duration of their therapy of their disease. Right. That makes sense. Maybe last one on ARCALYST, Sanj, for you. You know, when you think about the investments to make commercially, you know, you've made them expand the field, the field force some. What are you looking for sort of in terms of to see from the adoption rate to further invest in the business versus obviously the decisions to, you know, go back into the pipeline and maybe do external BD? I'm just trying to think of, you know, capital allocation among the sort of the different buckets. I mean, more of the same. I mean, we've obviously seen to date a steady progressive growth. Ross just elucidated the fact that we're expanding the sales force. It is a very sort of dispersed geographic setting for these patients and these cardiologists, in fact, and to some extent, rheumatologists. You know, the additional sales force will allow us to get out there. We expect a continued and hope for a continued steady progressive growth. Really, obviously, as you're sort of elucidating or, you know, highlighting, is that the pipeline is very attractive with KPL-404 in particular. We're around in the middle of a phase II study, an ascending dose study in RA. That'll read out in the first half of 2024. Clearly, aside from that continued execution in ARCALYST and continued steady growth, I think we're also very much interested in allocation towards KPL-404. It's part of the reason why I think in some ways we rationalized our portfolio in out licensing vixarelimab. As you may recall, we did a deal with Roche Genentech for $100 million in near-term upfront payments and then potentially significant milestones from that company. That kind of non-dilutive capital was very important to allow us to continue to allocate capital to programs like KPL-404. Similarly, with the deal with Huadong Medicine for both ARCALYST and mavrilimumab in China, a region that we would not have, you know, commercialized in ourselves. Again, bringing in non-dilutive capital. You know, I think at this time in particular, it's incredibly important. We're really pleased what we've seen so far with our CD40 program. Obviously, now really remains to be seen what the data looks like. We think we feel really good about the high concentration liquid formulation potential to allow subQ dosing, and potentially, you know, differentiate it. I think as we said at the very beginning, we're very data-driven. We look forward to seeing that. We'll make, you know, the next steps from there on out. It's certainly a good position to be in as far as Kiniksa is concerned. Yep. Yeah. Let's talk about KPL-404 a little bit. You know, you mentioned 2024. Are there any events between now and then either, you know, follow on from, you know, from prior studies or that we could, you know, further kind of help elucidate the other differentiation or, you know, maybe give us more confidence in the new dosing, the subQ dosing? Yeah. Maybe John can give a little bit of background. I'm sure Eben would wanna jump in 'cause he's very keen on the program too. Maybe John describe the design. At this point, what we've disclosed is that we will have data in the first half of 2024. We've not disclosed any other information that may or may not come along during the study design. John, do you wanna cover that? Sure. Happy to. As you know, we completed the single dose study, which really gave us a real window into what's, you know, potentially unique about KPL-404, which is that we have a high concentration liquid formulation that allows us, really enables, subcutaneous dosing at a practical level. We really wanted to carry that forward into this current study, which has really two phases. There's a pharmacokinetic lead-in piece, which is really a multiple ascending dose study. There's a parallel design efficacy portion. We're really testing the raw horsepower, if you will, of the mechanism, as well as of this drug and being able to benchmark that all with subcutaneous dosing, you know, against, you know, other assets in this space. We can certainly go into the specifics of the data or of the design, but that's kind of the overarching objective of what we're trying to accomplish with a relatively small sample size in a brief period of time. Right. And obviously RA, you know, is the leading indication here, but from a mechanism standpoint, maybe just help us with how you think about this in other, I&I indications potentially. Yeah. Eben, do you wanna cover that? Yeah, sure. I can certainly start us off. One thing that we actually like a little bit about the CD40, CD154 antagonism space is that there are high-dose IV approaches ahead of us, which provide a really good base of reduced risk paths forward if they're to achieve success, where we could follow behind with a, with a more conveniently administered program. I think at last count, there, you know, have been up to 12 or so different indications either studied or being studied with this mechanism. We think, you know, really important mechanism for a whole host of diseases, either, you know, purely autoimmune, or antibody driven and/or with a Th1 tone. We're, as Sanj and John both mentioned, really excited to see the RA data and move forward as quickly as possible. Perfect. Okay. From a long-term strategy perspective, Sanj, when you get to a de-risking point with this, with this program, you know, is this something you think that you could, you know, take forward into a larger scale study if successful? Or is this, you know, potentially an out-license opportunity? I mean, it really depends on the data and how we progress. you know, I think we've shown that we can do innovative deals, both the Roche deals. As As well as the Huadong Medicine deal. I think, you know, depending on how good that data is, I think that can open up an awful lot of optionality, both, you know, not just the value that could be created by positive data in RA, but also, you know, as we've said before, there are a number of other rare, devastating autoimmune conditions that CD40 is perfectly positioned for potentially. The rarer indications we would most likely like to execute on ourselves, but we're certainly open to, you know, partnering as we've done before, providing it creates the, you know, the right amounts of value for the company. And that's what we're always focused on. Yep. Perfect. Let's talk a little bit about, you know, about mavrilimumab. You still have some residual development there. Just give us kind of where this fits into the strategy, you know, at Kiniksa and the, you know, kind of priorities in with respect to capital allocation. Maybe I'll start, and then if anybody else wants to jump in feel free. This is a molecule that we're still very excited about. As you recall, it's shown positive safety and efficacy through phase IIb in RA. Obviously we had positive phase II results in GCA as well, giant cell arteritis. Really, I think, you know, obviously building the sales force that we've had, it mainly focused on cardiology. We felt it was the right time to pivot mavrilimumab to more rare cardiovascular indications. We're doing that through collaborative research agreements, which obviously is more of an efficient way to generate data on that. You know, we have obviously the deal with Huadong is for mavrilimumab and ARCALYST in Asia Pacific, excluding Japan. There is obviously hopefully value being created there, a number of other milestones. Sort of, more to come and watch this space with mavrilimumab. Clearly, 404 is the one that's gonna get the bulk of our allocation and our attention. We still very much like mavrilimumab, and we think there's a lot of value that can be created with that mechanism, especially knowing that it has had some positive phase II data to date. Yep. Perfect. Okay. Then Sanj, you mentioned, you know, the Roche Genentech deal and, you know, just give us a sense. I mean, this is obviously an example of doing a pretty creative deal, very capital efficient. Just the thought process, you know, behind that really. Yeah. I mean, first of all, first and foremost, we love vixarelimab. You know, great molecule antibody focusing on IL-31 and OSM. I think obviously you'd have to be blind not to realize the current market conditions and non-dilutive capital is very, very important. While I think we were fully prepared to continue that molecule, you know, we were certainly aware that there are others in that space. Roche were very keen. You know, they'd followed us for a while, as had other large pharma partner companies interested in that mechanism. They just convinced us that we're very keen to actually not just, you know, take it on or license it, but also actually license it and pursue the other indications, which again, could potentially mean even more non-dilutive capital through milestones. It was the right thing to do at this particular time, given the need for non-dilutive capital and, as you said, important areas where we can allocate capital. You know, bittersweet, but I think a brilliant deal for Kiniksa at this point in time. Yeah. Yep. Yeah. Lastly, you know, when you think about the external landscape, you know, BD, M&A, et cetera, you know, are you guys? Can you give us a sense for, you know, how aggressive you would be from here? It seems to me you have a lot going on already commercially and pipeline-wise. I wasn't sure, you know, whether you know, would be looking at, you know, other, you know, maybe earlier stage stuff to kind of add to the, to the platform or portfolio. We are very much focused on BD and Eben and his team. In fact, Joseph Boncore was one of our earliest BD associates, left about a year and a half ago, and has now come back as chief business officer, and he is certainly working with Eben to look at assets. You know, I often say there's an awful lot out there, but there's awful lot of things out there that don't have the quality that we would desire. Our bar is very high, obviously, as you've seen from the data we've generated in our current portfolio. We are looking, but unless we are convinced it will create more value, we're gonna be incredibly discerning, to that point. It's certainly a large focus for us. As you've said, as I said, augmenting and rationalizing is very important to create the value that Kiniksa deserves, and, we're very much focused on. Perfect. All right. We'll look forward to seeing you, next year and, you know, happy holidays and, you know, 2023 is gonna be fantastic, so. Good to see you guys. Go England on Saturday. Right. All right. I have no one else to cheer for. No France. Okay. That's right. All right. See you guys. Take care. Thank you. Yep. Bye.