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

Okay. Let's go ahead and get started. So welcome, everyone, to the first day afternoon session of the 41st Annual J.P. Morgan Healthcare Conference. My name is Anupam Rama. I'm one of the senior biotech analysts here at JPMorgan. I'm joined by Priyanka Grover and Malcolm Kuno from the team. Our next presenting company is Kiniksa, and presenting on behalf of the company, we have CEO, Sanj Patel. Sanj?

Thanks, Anupam. Thank you to JPMorgan for hosting us today. It's been a wee while since we have done these types of presentations in person. So it's great to see all of you again here today. Kiniksa has a pipeline of assets that have the potential to help patients that have a range of cardiovascular and autoimmune diseases. We are well positioned for both near- and long-term growth, and I'm really excited to give you an overview of the company today. First, please note that I will be making forward-looking statements that are subject to risks and uncertainties. A review of those statements and risk factors are found on this slide -- that slide of the heading of Risk Factors in our SEC filings. We started this company in mid-2015 with a blank piece of paper. But what we did have was a lot of energy and passion to help patients suffering from debilitating and devastating diseases. Fast forward to today, we've got one approved and commercialized product that is growing revenues. And we also have a pipeline of mid-stage clinical assets that are all designed to also help make a big impact on patient lives. We are very much focused on building a generational company by acquiring, developing and commercializing our assets. Business development is a key part of our strategy. We've shown that we can focus on augmenting and, when it's strategically appropriate, rationalizing our portfolio. And if you know anything about us, you'll know that consistent execution is one of our biggest traits. Since starting the company just those few years ago, we materially advanced all of our programs. This slide gives an overview of all our assets. The company consists of 2 main pillars: a cardiovascular franchise and an autoimmune franchise. Within the cardio franchise, we have ARCALYST. This is a once-weekly inhibitor of both IL-1 alpha and IL-1 beta. It is the only FDA-approved therapy for recurrent pericarditis, which is a debilitating autoinflammatory disorder. And it's also approved in the United States for CAPS and DIRA, which are both rare autoinflammatory disorders. And talking of execution within just 4 years, we completed a Phase II study, a Phase III study, got breakthrough therapy designation, orphan drug designation, got FDA approval for recurrent pericarditis, and that was in March of 2021. And since then, April onwards, we've had a successful launch, and the sales continue to grow. Another pipeline program is mavrilimumab. This is a monoclonal antibody that targets GM-CSF receptor alpha. And this is a program that's been through 2 successful Phase II studies in both RA and giant cell arteritis. And we've now pivoted our focus to cardiovascular indications through collaborative research agreements. Moving to the autoimmune franchise. We have KPL-404. This is a monoclonal antibody that inhibits the interaction between CD40 and CD154. We are very excited about this molecule. It has the potential to really block a number of T-cell dependent, B-cell-mediated autoimmune-related diseases. We're currently in the middle of a Phase II study in RA with this program, and there are indeed a number of other autoimmune diseases that we can focus on. At the bottom of this slide is an example of us rationalizing our portfolio to create more value. In the second half of last year, we did a deal with Roche Genentech to out-license vixarelimab. This was our IL-31 and oncostatin M molecule. And I'll tell you a bit more about that deal in a wee while. Next slide, starting with ARCALYST. We've made tremendous progress since launching in recurrent pericarditis. And you can see from the large separation on the [indiscernible] on the right in the picture that rilonacept proved to be highly effective in reducing the risk of recurrent pericarditis in our pivotal Phase III study that we call RHAPSODY. In fact, new recent long-term extension data was highlighted at the American Heart Association just late last year, and this showed that treatment with rilonacept for more than 18 months resulted in a continued response. And it's really [ facts ] that those data and the clear benefit for patients that ARCALYST continues to shape the treatment paradigm and very much has gone towards the success of the launch and that continued growth that we're seeing. This slide highlights the addressable patient population in recurrent pericarditis. Since that launch, some 21 months ago, our field force has been very much focused on the target patient population. There are, in fact, 14,000 patients that are suffering from 2 or more recurrent pericarditis events every year. And beyond that 14,000, there's another 26,000 that are on their first recurrence. And thanks to the broad label, we're already seeing some physicians prescribe for those additional patients. Frequent call activity has been a major driver of prescribed understanding of both the disease burden and the ARCALYST adoption. And in fact, our recently expanded field force of around 50 clinical sales specialists has gone a long way to increasing our call activity as well as providing a solid foundation for future potential commercial growth. This slide gives an overview of our unaudited Q4 and full year 2022 net revenues, and that was released as part of our press release this morning. Q4 represented another quarter of consistent growth. In fact, our Q4 number of $39.9 million is approximately 20% sequential growth versus the previous quarter, Q3. Our full year 2022 net revenue is $122.5 million. And that, by the way, is right in the middle of our previous guidance that we gave at the beginning of the year, which was $115 million to $130 million. And so far into the launch and certainly through Q4, we've seen approximately 5% penetration into the target patient population. And we believe there's still considerable more potential commercial growth within the recurrent pericarditis opportunity. This slide gives you an overview of the key drivers behind the ARCALYST revenue growth and certainly the numbers we've seen through Q4. Since launch, there have been more than 800 unique prescribers that have written for ARCALYST with recurrent pericarditis. And 22% of the total prescribing base have actually written for 2 or more patients. In terms of payer access and while payer dynamics are typically fluid at this time of the year, we've seen an approximate approval rate of more than 90% for all the completed cases. In terms of duration of therapy, I mentioned that long-term extension data at AHA. That's really gone a long way to support the fact that patients need to be treated throughout the course of their disease. And again, continued treatment results in a continued treatment response. In the commercial setting, in fact, the average duration of therapy was around 12 months, and that could, of course, evolve over a longer period of time. And in terms of those patients that came off therapy, we've now seen around 45% of them go back on to ARCALYST and most of them within just 8 weeks. Slide 9. The bottom line is we are just getting started. Before launch, we said that we expected a steady sequential growth, and that's exactly what we've delivered. You can actually see on this graph consistent revenue growth quarter upon quarter. In fact, from the Q2 launch in 2021 through the end of Q4 2022, we've had a cumulative net product revenue of $161 million. Now of course, we're very pleased with the launch to date, which by -- is no means a given in biopharmaceutical drug launches, and we're very much looking forward to providing our full year 2023 net revenue guidance along with our Q4 2022 financial results. And I do want to say that in addition to our focus on the commercial growth and the increasing sales, we are also very much focused on quality and compliance. In fact, we're very much invested in it, and it's one of our core strengths. Slide 10 and moving on to the pipeline and KPL-404. This is our CD40 antagonist program and one that we're incredibly excited about. The optionality that our high-concentration liquid formulation could provide in targeting other chronic diseases is very compelling. This is an asset that we acquired via an acquisition of a small Massachusetts-based company called Primatope. That acquisition occurred in 2019. And at that point, the asset was a preclinical-stage molecule. We quickly took it into a Phase I study, and those data informed our ability to potentially have longer-term administration, potentially through subcu in autoimmune diseases. And what's also really compelling about this molecule is that Kiniksa owns the vast, vast majority of the economics. This graph should tell you why we are so excited about the potential for KPL-404. That high-concentration liquid formulation translates into our potential ability to deliver large amounts of drug through subcu dosing. And the PK/PD data you see here give us the potential to reach the type of plasma concentrations that we think are necessary to see efficacy in the clinic. And while there are other CD40 programs in clinical trials, we believe that KPL-404 has the potential to be the best in class. Those data is why we're so focused on the ongoing Phase II study in rheumatoid arthritis with KPL-404, and you can see the design on this slide. This is a multiple ascending dose study that initially evaluates both the PK and safety of 404 and then transitions into a parallel dose group efficacy portion. We fully enrolled both the cohort 1 and cohort 2 of the PK [ leading ], and we're now focused on starting the final cohort, cohort 3 of the efficacy portion. And we expect to have the proof-of-concept data from this study in the first half of next year. In addition to rheumatoid arthritis, the CD40-CD154 interaction has been implicated in a number of other devastating diseases. These include Sjögren's, Graves' and systemic lupus. These are all diseases where the external proof of concept has already been demonstrated. Of course, moving forward, we plan to be highly data-driven, certainly looking forward to that Phase II data in RA in the first half of next year. And really positive data there could really demonstrate the potential of this molecule. Slide 14 and moving on to some business development. In February of last year, we signed a deal with Huadong Medicine for the development and commercialization rights for both ARCALYST and mavrilimumab across the Asia Pacific region but excluding Japan. As part of that deal, Kiniksa received $22 million upfront and could receive a further $640 million in various milestones. Now of course, that deal was important because we did receive nondilutive capital, but we also received additional resources that allow us to continue to develop and commercialize our own products. I do want to say that Huadong have been a great partner. In fact, just 12 months from signing that partnership, they've already filed a BLA for CAPS in China. And if that's approved, there will be additional nondiluted capital into Kiniksa. I mentioned earlier the deal that we did with Roche Genentech for the global rights to vixarelimab. This was another very important deal for Kiniksa. It really provided to -- potentially up to $100 million of near-term payments. In fact, $80 million of that has already been received, and we should receive another $20 million in short order upon Kiniksa's delivery of certain drug supplies to Roche Genentech. We could also receive up to $600 million in various milestones on this partnership. And I do want to say that while we know that vixarelimab had a lot of potential in our hands, we also think it was the right deal to do this particular time, given that capital allocation and nondiluted capital are now more important than ever. In summary, Kiniksa is rapidly becoming an emerging leader in producing immune-modulating therapies. Thanks to consistent execution in 2022, we've set the stage for more success and growth in 2023 and beyond. We've got a really exciting growth opportunity with ARCALYST. We've seen the sales continue to grow. We've got a pipeline of mid-stage clinical assets that all have the potential to also make a big impact on patient lives. We are very much focused on the ongoing Phase II study in rheumatoid arthritis with KPL-404 that the data comes out just in the first half of next year. We continue to be focused on business development, consistently evaluating value-creating opportunities through both in-licensing and, when it's appropriate, by rationalizing and out-licensing, bringing in significant nondilutive capital into the company. As a result, we are well capitalized, and we have operating funds that will allow us to operate until at least 2025. Ultimately, we are very determined to continue to help patients and build sustainable value. So with that, I want to thank you all very much. Please stay healthy. And I'll hand it back to Anupam for the rest of the session and some of the team members.

Yes. Okay. Thanks, Sanj, and I wanted to highlight a couple of things that there is microphone runners here. So if you want to ask a question, just raise your hand. And if you're shy, you can send a question in the question portal, and I'll look at it and ask it on your behalf. Sanj, maybe as a first question, what are some of the early trends from the increased sales force? What's the timing of how we should be thinking about a pull-through and then where we can see it in sales? I get it. It won't be completed [indiscernible].

Yes. No, thanks, and if I mention -- by the way, I do have a few members of the team here who may jump in. We've got Ross Moat, who's our Chief Commercial Officer; Eben Tessari, who's our Chief Operating Officer; and John Paolini, who's our Chief Medical Officer. But maybe Ross, I'll take a start, and you can jump in. So as you say, the field force expanded from around 29, 30 field reps at the time of launch, which is very much a targeted approach. And just starting in Q4, we began to increase that up to about 50 clinical sales specialists. So it is somewhat early in the process of that expansion. Clearly, we felt that an investment in the field force was the right thing to do in this particular time. And I mentioned earlier on that frequent call activity is one of the main drivers behind physicians really prescribing, understanding the disease burden and how to adopt ARCALYST. But Ross, maybe you want to give some of the early trends. I think it is a wee bit too early, but I'll let you talk about that.

Yes, absolutely. Thanks. So yes, I think you highlighted very nicely that we built the increased building throughout Q4. So that was the process of the recruitment, our board-in training were very robust in making sure people are fully trained and get it up and running in the field. So it's a process. I think we've seen a lot of that happen throughout Q4, and we're awaiting the results. I guess what we have seen is early metrics in terms of activity that's rapidly ramped since we have a bigger field team on board. And then we are waiting to see how that kind of translates into more results of helping more and more patients across the U.S. But we were pleased to be in a situation where we can increase the size of the field team because we understood from our initial launch with a very lean team, we drove towards profitability for the collaboration as quickly as possible just 3 quarters after launch and then invested in the larger field team because we understood that physicians were very receptive to the quality of the data and the unmet need in recurrent pericarditis. So we felt it was the right thing to do to take that opportunity to increase the team, and we await some of the results from that.

We do have a question in the queue, which is -- actually, it went away. I think it was along the lines of what are you doing to get ARCALYST more in the guidelines for the treatment of recurrent pericarditis?

Yes. Maybe I'll pass over to John Paolini, but starting with the fact that I highlighted the new long-term extension data, which I think was very compelling, I think, in some ways, even actually tops the RHAPSODY data in terms of the p-value and the hazard ratio and showing that patients really need to be treated throughout the course of the disease. But John, specifically in the guidelines, I know you've done a lot of work. Do you want to comment on that?

Sure. Thank you, Sanj. And thanks, Anupam, for the question. So with regard to treatment guidelines, at this point, there are and have been no treatment guidelines in the United States for the treatment of recurrent pericarditis. There are European Society of Cardiology guidelines that are really outdated at this point. They come from 2015. And so at this point, what we are seeing rather than the guidelines themselves is actually a population into the literature by academic experts about the evolving treatment paradigm of recurrent pericarditis based upon the fact that ARCALYST is now the first approved therapy. And what you see in these practice papers, if you will, or white papers is a shift in the treatment paradigm that instead of -- after NSAIDs and colchicine instead they're progressing to corticosteroids, these papers are now recommending progressing directly to IL-1 antagonism, specifically with ARCALYST being -- or rilonacept being the first approved therapy in the United States. So that's a period of evolution as the data continue to be processed and the therapy evolves.

Questions from the audience? What are the keys to getting repeat prescriber growth?

Yes. Maybe I think -- I'm happy to address that. I think that's something that's vitally important. We've been pleased to share since the time of launch, a constant increase to the prescriber base has been increasing by more than 100 every single quarter since we launched and, in fact, in Q4 by 150, which took us up to more than 800 individual unique physicians who have prescribed ARCALYST for recurrent pericarditis and around 22% of those who have prescribed for 2 or more patients. So I'm very, very pleased with the growth that we have there, but we must be focused on the breadth and the depth of prescribing. And in order to do that, I think the important thing is for our field team to be very focused on where the opportunity is with the physicians, those that have the highest throughput of recurrent pericarditis patients because there are probably many cardiologists around the country who may see one recurrent pericarditis patient in a year or in 18 months. It's going to take a long time for the repeat prescribing to build. So we are very, very focused since we have a lot of work to understand the data where the throughput of the patients are, so we can really focus on those physicians. And we'll have the opportunity to prescribe for more and more patients as we move forward. And then I guess the second part of that as well is making sure that physicians, when they do prescribe ARCALYST for recurrent pericarditis, they have a smooth prescribing experience in terms of writing the script, the enrollment form, the patients getting access through to ARCALYST from the payer and that gets done rapidly, the training of the patient on how to self-administer ARCALYST. And if all that goes well, as well as the patient reporting back to the physician, the efficacy and the outcomes that they have been on ARCALYST, we believe that will set the foundation for the continued growth for prescribing more ARCALYST for future patients as and when they see them.

What is the disconnect between, say, what you have on the slides, which is this is a 12-month therapy on average versus making it a chronic therapy because, John, I think you would say in the long-term extension data, there's plenty of evidence that once you come off therapy, your symptoms come back. So what's the disconnect there?

Yes. Thank you for the question. So that's very much been something that's been an evolving picture, out from launch. And in fact, the duration of therapy or the duration of treatment has grown since our expectations in the early stages of launch. What we see is that the majority of patients, on average, are being treated with ARCALYST for about 12 months approximately. And then also, we're seeing that there are a high number of patients that restart ARCALYST after stopping therapy. And we announced that was around 45% of all of those patients who have stopped therapy have gone back on to ARCALYST within about 8 weeks of stopping therapy. So with the evolvement of the long-term extension data, we understand that recurrent pericarditis is a chronic autoinflammatory disease, and ARCALYST must be prescribed throughout the duration of the disease in order to maintain disease control and prevent recurrencies while they're on treatment. And if you stop too early, then it's the risk of unmasking the underlying autoinflammation and patients suffering symptomology again, and we know that they can go back on to therapy. And we've got very robust data to show that. But we really want to make sure that physicians are prescribing throughout the course of the disease. So I think the long-term extension portion of our RHAPSODY study has been very helpful in really explaining the chronic disease that we're dealing with.