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

Ladies and gentlemen, thank you for standing by, and welcome to the Kiniksa announces the FDA approval of ARCALYST for recurrent pericarditis conference call. [Operator Instructions] As a reminder, today's conference call is being recorded. I will now like to the conference over to your host, Mr. Mark Ragosa, Chief Financial Officer. Sir, you may begin.

Thank you, Valerie. Good evening, everyone, and thank you for joining Kiniksa's call to discuss the FDA approval of ARCALYST for recurrent pericarditis. Our press release announcing the approval as well as the presentation for today's call can be found on our website under the Investors & Media section. As for the agenda, our CEO, Sanj K. Patel, will start with an introduction. John Paolini, Kiniksa's Chief Medical Officer will follow with a review of the ARCALYST label and the specifically significant data from RHAPSODY, our pivotal Phase III trial in recurrent pericarditis. Ross Moat, the ARCALYST's General Manager, will detail our commercial operations and strategy. And finally, Sanj will return for closing remarks before we start the Q&A session. Before getting started, please note that we'll be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. A review of these statements and risk factors are found on this slide as well as under the heading of Risk Factors in our SEC filings. And with that, I'll turn the call over to Sanj.

Thank you, Mark. Good afternoon, everyone, and thank you for joining us on this very exciting call. I'm thrilled to be here today to discuss the FDA approval of ARCALYST, previously known as rilonacept, for the treatment of recurrent pericarditis and reduction in risk of recurrence. This is a massive milestone for patients with recurrent pericarditis and indeed for Kiniksa, and as is the first and only FDA-approved therapy for this painful and debilitating autoinflammatory disease. We believe the approval of ARCALYST represents a transformational therapeutic advancement in the treatment of patients with recurrent pericarditis. Less than 6 years ago, we set out to build a company to help patients suffering from devastating diseases. And only 3.5 years ago, we in-licensed ARCALYST, which is also approved in CAPS and DIRA from Regeneron to develop it for the potential treatment of recurrent pericarditis. Throughout this time, we've been exceedingly focused on improving the outcomes for patients. And this approval is a testament to our exceptional team whose hard work and unwavering devotion to patients has helped us achieve our first commercial launch. I'd like to take this opportunity to reiterate our sincere appreciation to the recurrent pericarditis community, which includes the patients, nurses, physicians and caregivers who participated in the clinical trials and that have played a critical role in getting us here today. While today is certainly an exciting day, this approval is just the first step making ARCALYST available to patients with recurrent pericarditis. And now we're focused on executing this launch with the support of our experienced U.S. commercial and medical affairs teams and helping to ensure that patients who may benefit from ARCALYST have access to it as quickly as possible. I'll come back later at the end of the presentation to share with you the rest of the exciting pipeline and the number of near-term milestones that we have coming up. Ross Moat, the ARCALYST General Manager, will discuss our tactical operational plans as well as the strategic commercial approach and the organization that we already have in place. But before that, I'll now turn the call over to Dr. John Paolini, our Chief Medical Officer, who will walk you through the ARCALYST label and the data that supported it. John?

Thank you, Sanj, and good evening, everyone. The approval of ARCALYST for recurrent pericarditis could be a potentially transformational therapeutic advance in the management of patients with recurrent pericarditis. We start, as always, with the patients. And it is important to remember that recurrent pericarditis is a painful and debilitating autoinflammatory disease. Recurrent pericarditis typically presents with chest pain, often associated with changes in electrical conduction and sometimes build up a fluid around the heart called pericardial effusion. The recurrent pericarditis episodes are painful and debilitating, lead to frequent emergency department visits and hospitalizations, and sometimes there are life-threatening complications. For these patients, this chronic disease is highly disruptive to quality of life. Until today, there have not been any FDA-approved therapies. These patients are typically treated with NSAIDs, colchicine and even corticosteroids often for years, but we have to realize that the treatment itself then adds to the morbidity of the disease. Putting it all together, from the patient perspective, beyond the severity of the disease and the side effects of the medication, the unpredictability of these recurrences forces changes in lifestyle in an effort often futile to avoid precipitating the next event. This can all result in significant anxiety and depression. Patients and physicians often resort to opioids to manage the pain. The main areas of unmet need that patients have identified are: resolution of acute pericarditis episodes; reducing the risk of subsequent episodes while on treatment; steroid-sparing disease control; and finally, improvement in their quality of life. Kiniksa wanted to do better for these patients. So the identification of the IL-1 alpha and IL-1 beta as key mediators of the disease created the opportunity to develop a targeted immunomodulation approach. ARCALYST is an engineered IL-1 soluble decoy receptor invented by Regeneron, which traps both IL-1 alpha and IL-1 beta. With a decade of clinical experience as an approved product in the U.S. for CAPS, ARCALYST appear to us to be ideally suited for the bench-to-bedside approach to treat patients suffering from this devastating disease. ARCALYST was initially approved in 2008 treatment of cryopyrin-associated periodic syndromes, or CAPS, including familial cold autoinflammatory syndrome, FCAS, and Muckle-Wells Syndrome in adults and children 12 years and older. And subsequently in 2020, for the maintenance of remission of the deficiency of interleukin-1 receptor antagonist, or DIRA, in adults and pediatric patients weighing at least 10 kilograms. ARCALYST has now been approved for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The data that have been incorporated by the FDA into the label underscore the strength of the data from the Phase III study, RHAPSODY, which was designed to inform both the treatment of recurrent pericarditis and the reduction of risk of recurrence. The results of this study were recently published in New England Journal of Medicine in November of 2020. RHAPSODY was a global pivotal Phase III clinical trial of ARCALYST in recurrent pericarditis, which utilized a randomized withdrawal design. While enrolling a broad representative recurrent pericarditis patient population, we focused the study on those suffering with the highest level of unmet need, patients with "idiopathic and post-cardiac injury pericarditis", who are acutely symptomatic, breaking through standard therapies, such as NSAIDs, colchicine and corticosteroids in any combination. We will now review these data, which are designed to inform those 4 data areas of unmet need and help clinicians and patients understand the data supporting how ARCALYST should be used. Data from the run-in period showed rapid resolution of acute pericarditis episodes with rapid and sustained reductions in both reported pain and inflammation as early as after the first dose. The median time to treatment response was 5 days with a 97% treatment response rate. Turning to tapering and discontinuation of standard of care treatments. Time to ARCALYST monotherapy was 7.9 weeks, 2 weeks earlier than the protocol specified maximum of 10 weeks. Approximately half of the patients in the study have been receiving corticosteroids at baseline, and these patients tapered off and transitioned to ARCALYST monotherapy also within 8 weeks. None of the patients treated with corticosteroids at baseline and randomized ARCALYST monotherapy experienced a recurrence while on therapy. The study met its primary efficacy endpoint, time to first adjudicated pericarditis recurrence and the randomized withdrawal period. This Kaplan-Meier curves shows ARCALYST recipients in purple, and placebo patients in gray. Median time to first recurrence in the placebo arm was 8.6 weeks after randomization, consistent with the expected washout pharmacokinetics of weekly ARCALYST at steady state. Almost half of those went on to suffer a recurrence event in the placebo arm did so within the first month after randomization, underscoring the tenacity of recurrent pericarditis. Median time to first recurrence in the ARCALYST arm could not be calculated as there were not enough recurrent events during the observation period to allow for the number to be calculated. There were only 2 events in the ARCALYST arm, and these occurred after brief temporary study drug interruptions of 1 to 3 weekly doses. The hazard ratio of 0.04 means that patients randomized to ARCALYST experienced a 96% reduction in risk for a recurrent pericarditis event with a highly statistically significant p-value of less than 0.0001. Finally, bailout ARCALYST, when given to patients who experienced an on-study pericarditis recurrence, resulted in resolution of the acute episode. These data demonstrate that in this study of patients with recurrent pericarditis remaining on continuous ARCALYST therapy resulted in continued clinical response and a reduction in the risk of recurrent events. While on therapy, patient symptoms remain reduced and clinical response was maintained as evidenced by the major secondary efficacy endpoints in the randomized withdrawal period, which were also highly statistically significant. From the patient perspective, 92% of trial days through week 16 were reported by patients treated with ARCALYST as being pain-free or at most experiencing minimal pain versus 40% of trial days for those on placebo with a p-value of less than 0.0001. The warnings and precautions for ARCALYST remain the same as those for CAPS and DIRA indications, and the most common adverse reactions in the recurrent pericarditis clinical studies occurring in greater than or equal to 10% of patients included injection-site reactions, upper respiratory tract infections, myalgias and arthralgias. We believe that ARCALYST could represent a significant advance in the treatment paradigm of recurrent pericarditis in clinical practice. The main duration of recurrent pericarditis from real-world evidence is approximately 2 years from the first episode. RHAPSODY patients had 2.4 years of disease duration prior to trial entry. The data point to recurrence of inflammation and symptom breakthrough after premature cessation or interruption of treatment in patients with continued autoinflammation. The median duration of ARCALYST treatment in RHAPSODY was 9 months, up to 14 months to the point when the event-driven portion of the trial concluded. At that time, 74 out of 75 eligible patients rolled into the long-term extension, potentially indicating satisfaction with treatment and ongoing patient outcomes. In general, the duration of treatment will likely be individualized to each patient depending on the baseline characteristics and potentially supplemented with imaging data while on treatment to elucidate the severity and duration of the underlying autoinflammation and IL-1 production. One other important concept from RHAPSODY is steroid sparing. Nearly half of the patients entering the trial had previously been receiving corticosteroids, and these patients while on ARCALYST monotherapy had outcomes similar to the total population. In addition, the data also support potentially obviating the need to initiate steroids in patients who are failing NSAIDs and colchicine. Ultimately, these data support a potential paradigm shift in the therapeutic strategy from broad immunosuppression to targeted immunomodulation for the management of patients with this devastating disease. I'll now turn the call over to Ross Moat, the ARCALYST General Manager, to detail our commercialization strategy. Thank you.

Thanks very much, John. We're clearly very excited to have the approval of our first commercial product, not only does ARCALYST become the first and only approved drug in recurrent pericarditis that has the potential to become the standard of care. recurrent pericarditis represents the third indication for ARCALYST following on from CAPS and DIRA and further supports the utility of interleukin-1 alpha and beta blockade. As a reminder, Kiniksa now controls the full sales and distribution for all 3 indications in the U.S. Importantly, whilst our promotional efforts will be focused on recurrent pericarditis, we remain fully committed to serving patients who are and will be treated with ARCALYST across all of the indications. Turning to Slide 18. I'll take a moment to outline our field team. I'm happy to announce that we have fully hired our cardiology specialist sales team of 27 clinical sales specialists. They're onboard, trained and will be ready to roll over the coming days. This team have on average 16 years commercial experience with robust knowledge of virtual sell-in and drug launches. 2/3 of whom have extensive cardiovascular experience and the remaining have backgrounds in biologics or rare diseases. For several months, we've also had our payer team in the field conducting early payer engagement as well as our patient access leads who will support health care providers and patients during the initiation and journey with ARCALYST. Our medical science liaison team have been in the field for more than 2 years and continue to disseminate our compelling clinical data from the ARCALYST program. Our launch in recurrent pericarditis will be highly focused and targeted. Our focus is on the 14,000 patients on their second recurrence who have the highest unmet need in refractory multiple relapse in poorly-controlled and steroid-dependent patients. These patients have failed on current systemic, non-targeted treatments and require a solution that directly addresses interleukin-1 alpha and beta, the underlying drivers of pericardial information. This allows for a very clear call to action for health care providers. Slide 20 highlights our targeted strategy. Through market research and claims analysis, we believe that around 70% of our target patient population is concentrated at around 800 practice settings. During the early launch phase, our sales team will target the top 10 to 15 highest potential accounts per territory, which will cover around 45% of all the recurrent pericarditis patients nationally. This focus will help to enable rapid uptake within the target population and ensure the high-touch support during the prescribing and initiation period. Just a quick word on launch preparations in this COVID-19 environment. Since the start of the pandemic, we pivoted very quickly to using online tools, and we have been conducting all of our disease awareness activities virtually. Physicians are now quite used to virtual sales course, and our team are experienced in this environment and most have existing relationships with cardiology teams. Some areas of the country have returned in-person engagement. So where we can, we will utilize that but also continue with digital technologies for effective and compliant virtual engagements. Turning to Slide 22. I'd like to highlight some of our key activities. We've been conducting disease education for some time, including through heartofinflammation.com, which is designed for healthcare professionals and WhatIsPericarditis.com designed for patients. The community has been extremely responsive. We've had over 700 medical organizations visits, and now we have more than 1,000 patients and caregivers registered with Kiniksa, demonstrating strong engagement with the physician and patient community. Additionally, earlier this year, we launched a series of webcasts for patients suffering from recurrent pericarditis. Now that we have approval we will continue to boost these further to boost the awareness of ARCALYST and the importance of IL-1 alpha and beta inhibition. We now begin to rapidly communicate to the FDA approval to physicians, payers and patients. And the sales team have appointments set up with the top target accounts over the coming days, and our MSL team will continue to support disseminating the data and a final PI. We continue to have been very active with patient organizations, the Pericarditis Alliance, Myocarditis Foundation and the Autoinflammatory Alliance, all continue to provide excellent patient-to-patient support for this community. With the payers, we continue to be pleased with the receptivity of the data and the understanding of the disease. To remind you, the price of ARCALYST is $20,000 per month and has been established since 2008 with very broad commercial coverage for CAPS. In recurrent pericarditis, we received Breakthrough Therapy designation, Orphan Drug designation and are now the first and only approved therapy. The pricing is consistent with other specialty biologics, and we aim to secure broad access with minimal payer restrictions for our target population. We expect the majority of payers will establish favorable coverage policy within 6 months and almost all payers to have updated coverage policy within a year. In the meantime, given the current coverage in CAPS and DIRA, we anticipate that ARCALYST will be approved by some payers via an exceptional review, very typical for line extensions until full coverage is in place. We have invested in Kiniksa One Connect, our patient support program. This service will support both patients and physicians on their journey with ARCALYST. This service provides personalized one-to-one support for every ARCALYST patients through every step of the treatment journey. The Kiniksa Patient Access Lead will serve as the primary point of contact for health care providers and patients to support them with determining insurance coverage and benefit verification, assist them with the prior authorization and any appeals wherever required, provide an injection training during the patient's initiation and identifying any financial assistance for eligible patients. Patient affordability is one of the core principles of this program. The service will offer a suite of programs to eligible patients to ensure that patient gains access to treatments. Our patient services team are fully staffed and ready to guide physicians and patients. And before I hand back to Sanj, I'd like to say that having led many launches, I'm very encouraged by the early interest from target positions, the engagement from patients suffering from the recurrent pericarditis and the number of payer meetings that the teams have been completed. As this is a flaring disease, this launch is going to be a steady and progressive build. This early launch period is about getting the commercial wheels in motion and setting the stage for ARCALYST success for revenue to be built in the coming quarters. We're very excited by the opportunity ahead and look forward to supporting patients on ARCALYST. Sanj, over to you.

Thanks, Ross. Slide 26 is a reminder of the profit share arrangement with Regeneron. With the approval of ARCALYST in recurrent pericarditis, we will book and evenly split profits on sales of ARCALYST for all the approved indications in the U.S., that includes CAPS and DIRA, after deducting certain commercialization expenses subject to specified limits. We will pay Regeneron 50% of this adjusted gross profit, which will be reflected as a separate line item within the operating expenses. So before we take questions, I want to reiterate our excitement at this launch. We are extremely focused on building the maximum value across our entire portfolio. And the fact that we have multiple programs gives us a tremendous amount of optionality to allocate capital relative to the opportunity for the benefit of patients and shareholders. I'll give you an overview of the rest of our product candidates. We're evaluating mavrilimumab in giant cell arteritis and severe COVID-19 pneumonia and hyperinflammation. We have vixarelimab in Prurigo Nodularis. And last, but by no means least, we're also conducting a clinical trial for our anti-CD40 program, KPL-404. Each of our product candidates have the potential to be best-in-class therapies, and they're all supported by validated mechanisms. Additionally, the initial indication for each one of our product candidates offers potentially attractive commercial prospects as indicated by their current addressable populations. In terms of the commercial rights for our programs, we maintain worldwide rights for the 3 product candidates I just mentioned. We continue to be energized by our progress across our entire pipeline, and we have near-term data coming up in mavri and our anti-CD40 program in the first half of this year. And we believe we're well positioned to execute throughout this year and beyond. And importantly, we are very well capitalized. So with that, we want to thank you all for joining us on this call today. And operator, I'll turn it back to you to open up for questions. Thank you.

[Operator Instructions] Our first question comes from Paul Choi of Goldman Sachs.

Congratulations to you, Sanj and team, on the really quick march from in-licensing to approval. A few questions from us, please. Just looking at the label, it's pretty expansive. And on the safety side, it's not -- there's nothing really new. So I think in the trial, you had a median of like 3 prior events, and I think Rob spoke to targeting patients with 2 prior events. But I was just curious, since the label is not specific to the number of events, just how you think about potentially targeting the first recurrence population? Are they just harder to identify? And just how you think about targeting that incremental group of patients?

John, why don't I hand it over to you to take that?

Happy to. So your question really deals with the question of treatment of patients, maybe even as early as their first recurrence of pericarditis. In our view, scientifically, the biology is the same. Once these patients have been identified as having had recurrent disease, they tend to present very similarly with pain with elevated markers, specifically C-reactive protein as well as other pericarditis manifestations. And so biologically, it would make sense that with interleukin-1 being the partner mediator of their disease that targeted immunomodulation with ARCALYST that would be in a position to interrupt that disease. And the label, as written, is supportive of the treatment of patients who have recurrent pericarditis and does not specify a particular number of recurrences that are required.

Okay. And then maybe as a follow-up, can you maybe provide any updates with regards to the extension portion? And just where were duration of therapy or duration of treatment is shaking out? And just sort of your best sense as to what it might look like on the label because a fair amount of patients were continuing on to the extension portion. So just that, I think, provides a potentially meaningful driver to your revenue outlook. So any update there would be great.

So maybe what I can do is I can talk about the long-term extension and some of the elements of design, and then I can turn it over to Ross to handle the issues of the transition, if you will, from the long-term extension into commercialization. So with regard to your question about the long-term extension, yes, when the randomized withdrawal portion of the study closed, 74 out of 75 of the eligible patients transitioned to open-label ARCALYST. And so with that transition, they were eligible to receive up to 2 years of additional therapy. If you look in the American Heart Journal, where we have the study design published, you'll see there that after 18 months of continuous treatment from their most recent pericarditis episode, acute pericarditis episode, they are eligible for an evaluation potentially with cardiac imaging to either continue therapy for the full 2 years or to interrupt study drug -- to stop study drug under observation with the option to resume treatment if the pericarditis recurs. So that's how the trial is designed. At this point, there are patients at various stages of their follow-up therapy. So we don't have any additional information at this time about the rollout of the data. But I think more importantly, from the patient perspective, I'll turn it over to Ross to talk about the transition in the U.S.

Yes. Thank you very much, John. Thanks for the question, Paul. So RHAPSODY, as you know, is a global study. We had 74 out of 75 patients roll into the long-term extension portion of the study. And as you may remember, around half of those patients are enrolled in the U.S. So these patients are now able to convert to commercial supply without treatment interruption, if indeed the treatment in physician determines continued treatment is warranted for those patients. Ex-U.S. patients will remain in the extension for up to 2 years of treatment.

Okay. And maybe just one more quick one to Sanj. Just on the EU or rest of world strategy, just any updated thoughts there on the regulatory path and the potential timing?

Yes. Thanks, Paul. So obviously, our current efforts are now focused on the commercialization of ARCALYST in the U.S. But in parallel, we are absolutely exploring opportunities for other regions, including EU and Japan, Asia, potentially South America. But at the moment, we're focused on the U.S., and we are in parallel doing that work. So hopefully, more to come.

Okay. Great. And congratulations again.

Our next question comes from Geoff Meacham of Bank of America.

This is Jason on for Geoff. Congratulations on the approval. Just a few from us. In terms of thinking about uptake, where do you see kind of the greatest potentials for bottlenecks? And given how much you've invested already into the launch strategy, how meaningful do you think these are going to be? I'm just thinking in terms of kind of the payer willingness and what does that look like.

Yes. Jason, happy to take that question. Thank you very much for the question. So yes, we're really excited by making it to market and being able to reach patients now in recurrent pericarditis. We've put a lot of prework in the prelaunch environments around disease education, really sharing a lot of awareness and education around the disease. And now we're at the time of launch. We know that there will be some bottlenecks there in terms of the patient throughput. We know recurrent pericarditis is a flaring disease, but we spent a lot of time really working with the community. And we have a pool of patients, as I said during my main presentation, those are registered with Kiniksa now. And we think the patients will really mobilize towards their physicians now that we have a broad label in place. The point that you mentioned around payer reimbursement, it will take some time to get the payer coverage in place and for the launch to really have policies fully finalized. However, we have a Kiniksa One Connect service that's now going to be up and running, really supporting the physicians through the prescribing and then gaining the coverage for patients through the exceptional review process where that's possible for the patients. So as I said, I think it will be a slow and steady build because of some of those reasons as well as others. But we're confident in the data that we have and the engagement that we've had with payers, patients and physicians to this time point to get patients prescribed and initiated on our [ list ].

Perfect. That's very helpful. And then can you comment on maybe the potential of moving upstream, so perhaps in more of an acute setting or kind of an initial bout of pericarditis? What's the potential of using ARCALYST in that sort of treatment setting where maybe the patient has higher risk of recurrent, but maybe isn't quite there yet?

Yes. Thanks, Jason. Maybe I'll take that as well and hand over to John, if you have anything to add additionally afterwards. Ultimately, we're really pleased with the broad label that we just got from the FDA. That certainly supports our target population, which is the 14,000 patients that experienced multiple recurrencies. We think they are the patients that are most in need and really where we want to start. In time, quite possibly, physicians may expand the utilization. One example may be in the group of patients that have just one recurrence, but a high-risk factor categories such as cardiac tamponade, a significant fusion or constriction, but that may happen over time. At launch, our focus is really going to be on those 14,000 where we have very solid, compelling data behind and there's a clear call to action from physicians to treat those patients.

[Operator Instructions] Our next question comes from David Nierengarten of Wedbush.

Congrats. I had one question, maybe it's related to a couple of the earlier questions. But in your discussions with payers, understanding that this is probably going to be in patients for the second or third recurrence, have you had any discussions on -- or with those payers on whether there might be a time limit or speaking to an earlier question about the duration, a time limited therapy, like when -- or in discussions with doctors, is there a duration where a doctor feels the patient is likely to have a long-term relapse? Is there any thoughts around that, just thinking about when is the patient considered essentially a responder and unlikely to relapse? And if that has any bearing on duration of therapy in the clinic now that you're going to be commercialized or in discussion with those payers?

Thanks very much, David. I'm happy to make a start on that question. Again, I'll just can add if they have additional insights to provide. But yes, I mean, as I say, certainly, we're going to be focused on a core group of patients, and we'll wait and see what the payer reaction will be after we get out a message post-launch now, but been really happy with how the [ sponsorship ], they've been in the lead up until this time. In terms of treatments, we're really focused on those with 2 or more recurrencies. There are other treatments that are used earlier on in the disease costs, which are non-targeted and systemic, such as NSAIDs and colchicine and often corticosteroids as well. We think that NSAIDs and colchicine will really kind of keep us the mainstay for that first acute pericarditis episode and likely on the first recurrence very often as well. With corticosteroids, however, they are linked to disease recurrence and longer disease course. They're linked with substantial safety and toxicity concerns. So really having an ability to win patients off corticosteroids or to act as a steroid-sparing agents, I think, has a strong place and both payers and patients and physicians will want to avoid the approach.

Right. And then maybe for me just to add in the RHAPSODY data. So in terms of the evidence base, specifically with ARCALYST, and the treatment experience in RHAPSODY was a median of 9 months of treatment and up to 14 months of treatment at the time that the event-driven portion of the trial was concluded. And at that point, that was when the patients transitioned over into the long-term extension for open-label rilonacept. So I think that adds a little bit of additional information about the experience with rilonacept in the management of disease, especially when thinking about the fact that the reduction in risk that was associated with that treatment was a 96% reduction in risk. And while patients were on that continued therapy, 92% of trial days were associated with another minimal pericarditis pain.

I guess, maybe is there -- when you've discussed these findings with doctors, is there an agreement that this should be a -- really a longer-term treatment? Or like I said, is there more of a perception that I would treat a patient for a year or so and feel that they're unlikely to relapse in the future? Is that unknown at this point? I'm just curious if that's evolved with doctors as you build awareness lately.

John, do you want to go?

Yes. So what we know from some of the registry data, is that -- well, we know 2 things. One is that many of these patients, certainly the ones that are on steroids, are often in treatment often for years. And so that gives you a sense of the duration of the disease in general terms. We also know from some of the different registry data that if there's interruption of treatment or premature termination of treatment, that that's associated with worse outcomes and recurrence of disease. And that was shown in some of the European registries. And actually, you even see it in RHAPSODY, where you see that the 2 patients for -- the only recurrences that took place in the ARCALYST arm, for example, there were only 2 of them, and those occurred in the setting of temporary study drug interruption of 1 to 3 doses. So I think what that tells you is that as long as autoinflammation is present, that then continued treatment results in continued treatment response. And so I mean that's, I think, the educational piece that we'll work on with physicians to make them aware of the data.

I'm showing no further questions at this time. I'd like to turn the call back over to Sanj Patel for any closing remarks.

Thank you very much, operator. I appreciate everyone's time today. Obviously, we're very, very excited. It's been a great result for us. I just want to reiterate once more that we're obviously very pleased with the approval. We're pleased with the review that the agency, the FDA did. I'm going to remind everybody that ARCALYST is indicated for the treatment of recurrent pericarditis and reduction in risk of recurrence. So with that, I want to thank everybody for joining today, and I'm sure we'll be in touch soon. Thank you very much. Bye-bye.

Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating, and have a great day. You may all disconnect.