Kiniksa Pharmaceuticals International PLC (KNSA) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals Third Quarter Conference Call. (Operator Instructions)

I would now like to hand the conference over to your speaker today, Ms. Rachel Frank. Ms. Frank, you may begin.

Thank you, operator. Good morning, everyone, and thank you for joining Kiniksa's call to discuss our third quarter 2021 financial results and our recent corporate and pipeline activity. A press release highlighting these results can be found on our website under the Investors & Media section.

As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. Ross Moat, our Head of Commercial, will provide an update on the ARCALYST commercial launch; Eben Tessari, Kiniksa's Chief Business Officer, will follow with a brief pipeline review. Mark Ragosa, our Chief Financial Officer, will review our third quarter 2021 financial results. And finally, Sanj will return for closing remarks and to kick off the Q&A session, for which John Paolini, our Chief Medical Officer, will also be on the line.

Before getting started, please note that we will 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 such statements and risk factors can be found on this slide as well as under the caption Risk Factors contained in our SEC filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements, except as required by law. With that, I will turn it over to Sanj.

Thanks, Rachel. Good morning, everyone. I'm happy to review our third quarter 2021 results today. We continue to make tremendous progress in bringing ARCALYST to patients in need. And we're also executing across our portfolio of clinical stage product candidates. I'm delighted to report that net revenue for ARCALYST for the third quarter of 2021 was $12.1 million.

As expected, recurrent pericarditis was the major growth driver for the ARCALYST Q3 sales. Ross will cover our commercial performance in more detail in a moment.

We are very pleased with the implementation of our targeted commercial strategy. This includes broad physician and patient adoption and the viable reimbursement conditions. These core elements are what's driving recurrent pericarditis sales and underscore the significant need for ARCALYST.

Additionally, we remain focused on building the maximum value across our portfolio of clinical stage product candidates, and these are mavrilimumab, vixarelimab and KPL-404, which is our CD40 program.

We continue to expect data in the first quarter of 2022 from our Phase III trial of mavri in COVID-19-related ARDS, and Evan will highlight the potential opportunity in this patient population a little later. We continue to be energized by our progress across the entire portfolio and we believe that we're well-positioned for longer-term growth.

I'll now turn it over to Ross to discuss our commercial performance in more detail. Ross?

Thank you, Sanj. We're thrilled to report that Q3, our second quarter of launch, continued with very positive momentum and ended in great shape with a net revenue of $12.1 million. This represents a 57% quarter-on-quarter growth. And as anticipated, recurrent pericarditis was the major growth driver in Q3.

Revenue from CAPS and DIRA indications remain stable, and as expected, the one-off inventory build that we saw in the launch quarter did not repeat in Q3. Therefore, recurrent pericarditis demand grew from a base of approximately 1/3 of the $7.7 million in Q2 to more than 3/4 of the $12.1 million of revenue in Q3. We are delighted with the growth rate. It represents continued uptake and adoption of ARCALYST from physicians, payers and patients in this previously unmet and debilitating ultra inflammatory cardiovascular disease. Taken into consideration the early launch trends, we have provided a Q4 net revenue guidance of between $16 million and $17 million.

On Slide 8, I will dive into more detail on the drivers behind the recurrent pericarditis growth. We're very pleased with the continued broad physician adoption. At the end of Q3, there were more than 200 unique prescribers, who had written ARCALYST for recurrent pericarditis since launch.

This is more than double the number we reported in Q2, demonstrating rapid growth in the breadth of awareness and prescribing of ARCALYST. We're also starting to see an increase in prescribers who are rising for multiple recurrent pericarditis patients.

Since launch, the commercial team has engaged with around 4,000 physicians, representing more than 80% of the initial target accounts. Furthermore, while we hear many other companies are continuing to engage remotely, we're achieving in excess of 80% of these prescriber interactions face-to-face. This highlights the favorable access we have to our targets count as well as the eagerness of many physicians to learn about ARCALYST.

On the payer side, we continue to see that more than 90% of all completed recurrent pericarditis patient enrollments were approved for coverage. We're also pleased and encouraged to report that we have achieved broad access through finalized payer policies for our target population with greater than 190 million lives in the U.S. now having favorable coverage in place.

This is a higher and quicker coverage than our prelaunch expectations and allows physicians the confidence of gaining access when prescribing for their patients.

As previously stated, we continue to expect that almost all of the remaining payers will update their coverage policies within 1 year of launch. And additionally, whilst we're still too early to provide definitive updates on duration of therapy, it's important to state that so far, 2/3 of the ARCALYST prescriptions for recurrent pericarditis were written for 12 months of therapy.

This is an excellent market for how specialists are thinking about how long to treat a patient with recurrent pericarditis. However, ultimately, duration of treatment will depend on the duration of the underlying disease as well as the patient's willingness to remain on therapy and the payer approval duration.

When it comes to compliance, we're generally seeing the patients receive refills on time, and that almost all of the patients, who initiated ARCALYST in Q2 was still on therapy at the end of Q3.

On Slide 9, I would like to highlight how we're interacting with patients and healthcare professionals through our new marketing campaign. We recently launched our full promotional breakthrough campaign, which we believe reflects the strength of the data behind ARCALYST in recurrent pericarditis and the desire for patients to return to their normal lives.

We truly believe ARCALYST is becoming recognized as a breakthrough treatment that provides a targeted approach to the underlying driver of this disease.

Through our disease education initiatives, promotional, local and national webinars, social media and advertising, we have built a database of approximately 2,000 patients and caregivers across the U.S. who have opted in to receive further education on the disease and treatments.

In recent weeks, we initiated a tailored [communicate] plan to this patient group, designed to provide targeted information on recurrent pericarditis depending on the stage in their journey and to give them the tools and resources to ask their physician about ARCALYST.

Around 75 patients from the database and currently on ARCALYST treatments, and we anticipate this campaign will help to reach more patients in coming quarters.

Moving to Slide 10. I wanted to share some examples from the patient's perspective on the recurrent pericarditis and ARCALYST. Recurrent pericarditis is an incredibly painful and debilitating disease, and we have remained completely focused on the fact that patients are in need, and ARCALYST is the first and only FDA-approved drug for this disease.

These quotes directly from patients are an example of why the Kiniksa team are so focused and driven to secure a successful ARCALYST launch. We are here to support patients to break through from this disease and get back to their normal lives.

We're delighted with the Q3 results and we now have 2 strong foundational quarters from approval, and we look forward to continuing to deliver for patients in Q4 and beyond. Eben, over to you.

Thanks, Ross, and good morning, everyone. I will provide a brief overview on where we stand with our 3 clinical stage programs. Starting with vixarelimab, we're currently enrolling a global randomized, placebo-controlled Phase IIb dose-ranging trial in prurigo nodularis, testing 3 different once-monthly dosing regimens.

This is a first-in-class mechanism that targets OSMR beta, which mediates the 2 key cytokines implicated in pruritus, hyperkeratosis and fibrosis. The primary efficacy endpoint is changed in Worst-itch NRS at week 16, and we expect data from this trial in the second half of '22.

For KPL-404, we plan to initiate a Phase II proof-of-concept trial in rheumatoid arthritis by the end of this year. RA is a disease where dose response has been well characterized and this 12-week trial in RA patients is designed to provide not only PK characterization, but also an early signal of efficacy with chronic administration in a well-described patient population.

The results from this study may also enable optionality to evaluate the therapeutic potential of KPL-404 across a range of autoimmune diseases, with pathologies believed to be mediated by CD40 signaling.

Finally, we're encouraged by the broad potential utility of mavrilimumab, which has demonstrated previous positive clinical data across multiple indications, including giant cell arteritis and COVID-19-related ARDS, which we'll walk through in the next 2 slides.

Turning to Slide 13. We believe the treatment of hospitalized patients represents and will remain a significant market opportunity. Since the onset of the pandemic and despite over 175 million of the U.S. population being fully vaccinated, the rate of hospitalization has remained a multiple fold above the historical average of hospitalizations for influenza, which are around 400,000 cases per year on average.

We've seen the limitations of vaccines in terms of hesitancy and availability, resulting in the emergence of variance and the resulting upsurge in hospitalizations even among vaccinated individuals, and the therapeutic options for patients once hospitalized with pneumonia are limited.

As evidence of this, the last 6 months have seen the highest -- the second-highest surge of hospitalizations since the pandemic began, and that's in the context of between 100 million and 175 million Americans having been fully vaccinated.

While we hope the vaccinations and antivirals may reduce some of the hospitalizations to come, we fully expect that the rate will remain significantly higher than the seasonal influenza ARDS rate for several years to come, both in and outside the U.S.

With that market context and turning to Slide 14, I want to highlight mavrilimumab in our Phase III trial in COVID-19 ARDS, which is the next program for which we expect to have data. As shown here on this slide, based on our Phase II data, we believe mavri is differentiated in a potentially best-in-class therapeutic for patients with COVID-19-related ARDS.

As plotted here, either looking at absolute or relative mortality benefit versus other published data in the hospital setting, mavrilimumab could end up being positioned strongly in the market, if our Phase II data are confirmed in Phase III.

In April, we reported data from the Phase II portion of the study showing that day 29 mavrilimumab reduced the risk of death by 61% in hospitalized nonmechanically ventilated patients versus placebo. And in August, we reported that overall survival in the same nonmechanically ventilated cohort of patients was carried out through day 90. Those results demonstrate the persistence of the substantial mortality reduction over time, thus confirming and extending the previously reported day 29 data.

This effect of prolonged outcomes is also consistent with the prolonged pharmacokinetics of the single administration of mavrilimumab, which have been given on day 1. Currently, we're focused on completing our Phase III trial of mavrilimumab in COVID-19-related ARDS, and we expect data in the first quarter of '22.

With that, I'll now turn the call over to Mark to cover the third quarter financials.

Thanks, Eben. Good morning, everyone. Today, I'm going to walk through our financial performance for the third quarter of 2021 and review our guidance. You can find our detailed financial information in today's press release, and I'd like to call your attention to a few items.

First, third quarter revenue was $12.1 million, driven primarily by sales of ARCALYST in recurrent pericarditis, which more than doubled sequentially, as well as stronger-than-anticipated initial market access with greater than 190 million lives already covered in the United States.

Second, based upon execution to date and strong third quarter sales, we expect total ARCALYST net revenue of between $16 million and $17 million in the fourth quarter of this year. Third, as a reminder, Kiniksa is responsible for the sales and distribution of ARCALYST for the approved indications in the United States, including CAPS and DIRA and evenly split profits on sales with Regeneron.

When profitable, collaboration profit sharing will be reflected as a separate line item within operating expenses.

In the third quarter of 2021, we did not make a collaboration profit sharing payment. Lastly, net loss for the third quarter of 2021 was $30.5 million compared to $43.8 million for the same period last year, and we ended the third quarter of 2021 with cash reserves of approximately $200 million, which we continue to expect to fund our current operating plan into 2023.

And with that, I'll turn the call back to Sanj for closing remarks.

Thanks, Mark. Turning to the last slide, which is Slide 18. At Kiniksa, we are focused on building the maximum value across our portfolio. It's a very exciting time for the company. We continue to maintain a strong start with the launch of ARCALYST in recurrent pericarditis.

The positive feedback we continue to receive from physicians and patients validate the need for this therapy. As I mentioned previously, we are energized by our progress across our portfolio, and we believe that we are well-positioned to execute throughout this year and beyond. We are encouraged by the broad utility of mavri seen to date in COVID-19 and GCA, vixa in prurigo nodularis and KPL-404 potential in a range of autoimmune diseases.

Importantly, as Mark mentioned, we are very well capitalized and we have tax reserves of $200 million that are expected to fund our current operating plan into 2023. And with that, I want to thank you all for your time today. I'll turn the call back to the operator.

(Operator Instructions) Our first question comes from Anupam Rama of JPMorgan.

Congrats on the quarter. So you guys noted that 2/3 of prescriptions for ARCALYST are being written for 12 months. For the other 1/3, what type of duration are the prescriptions being written for? And are there any trends on the patient type that are getting a 12-month prescription versus another duration prescription?

Ross, do you want to take that?

Yes, very happy to. And thanks very much for the question. Nice to speak to you again. Yes, so 2/3 of the patients had prescriptions for 12-month duration, which is -- we were very pleased to see that because there's a good insight into how physicians are thinking about the duration of therapy. For the remaining 1/3, I mean, it was obviously not 12 months. So it really comes down to physicians and how they are expecting to see patients again in their follow-up clinics. So outside of those 2/3, there will be prescriptions there that will be for 3 months or be for 6 months.

That doesn't necessarily kind of interpret into what they expect the duration of therapy to be, but could moreover be expecting to see the patients again, kind of reassessing from the baseline and really understanding the treatment duration on from there and just making sure that they have that follow-up with the patient.

Particularly as physicians are reasonably new to ARCALYST, many of these physicians are prescribing for the first time. So they might want a kind of a closer patient follow-up that may happen in the longer term.

So hopefully, that answers that part of it. In terms of patient trends and patient types, I think at the moment, it is such low numbers in the early stages of launch that it's difficult to kind of correlate which patients are getting in what disease, which duration. So I think that's kind of difficult to answer right now. I'm not sure there is a correlation there.

But broadly speaking, we see 2 different types of patients. We see patients coming through that are clinically stable. So there are patient is either coming from our long-term extension study or they're coming from chronic steroids. And then we see patients that are symptomatic really suffering from the disease and really seeking a targeted treatment. So there's kind of 2 main categories of patient throughput that we're seeing.

But of course, the duration question even though that's what's been prescribed. So necessarily that means that that's what the actual eventual duration is going to be. The duration of the treatment ultimately will depend on the duration of the disease and also where patients are in the disease course as well.

What we do know is that continued treatment results and continued treatment response, and if you stop patients too early into therapy, there's always the risk that they will rebound and suffer from symptomatic disease once again. So we probably need more time to kind of tell what the actual eventual average duration is going to be in the midterm and look forward to be have to report on that in time to come.

Next question comes from Paul Choi, Goldman Sachs.

Congratulations on the quarter as well. I have -- first question is on commercial. With regard to -- as you go in to see doctors here, can you maybe just comment on what factors are being sited as potential hesitancy to get RP patients onto ARCALYST? Is it primarily just access or reimbursement? Or are they looking for any other particular pieces of information or clarifications?

So I'm happy to take that question as well. In terms of the headwinds or [barriers] or hesitancy there for patients to prescribe, I mean this is -- for doctors to prescribe, this is just still relatively early on in the launch. So it will be a first experience for many of the physicians. And I think that probably goes into the previous comments about wanting to see patients again and follow-up and see how they do in on the early stages of treatment.

Outside of that, we don't necessarily see hesitancy from healthcare professionals. It's just more of waiting to see the appropriate patients. Of course, this is a rare disease and a flaring disease. So we need to do a lot of education and make people aware of this targeted treatment and the first treatment was approved now for recurrent pericarditis. And we're having a very successful meetings with physicians, and when patients do come through, we think, we'll continue to see the uptake prescribed.

Access and reimbursement is always a question for physicians, particularly when a drug is reasonably new on markets. But what we've seen so far in the payer side of things is really quite successful approval rates. As we mentioned, we still have more than 90% of all completed cases approved. And now that we have payer coverage in place much more broadly now with more than 190 million lives covered across the U.S., hopefully, that will also provide a lot of confidence for physicians as well as speed up the time through to approval and get patients on to therapy as quickly as possible.

Okay. That's helpful. And then, I think this question is on the pipeline. So maybe for Eben. Just I don't know, if I missed it on the slides here, but can you maybe just update us on what is the status of the Phase III plans for mavri in GCA, timing and trial initiation and so forth and trial design?

And then also, could you maybe help us understand how you're thinking of potential development here and thinking about the trial in the context of Novartis recently announcing positive Phase II data for their IL-17 secukinumab?

Paul. This is Sanj. Maybe probably, question may be (inaudible) better directed this is John, but I'll make a few comments. So obviously, we're very pleased with the Phase II results that we had in GCA than really showed a potential for true differentiation there. We've not disclosed or commented on further next steps immediately in terms of timing for GCA, but John can give you an idea as to what we've disclosed in the past and potential trial designs. So John, over to you.

Sure. Happy to do that, and nice to talk with you again. With regard to the design, I think, what we've discussed before and what we've said we've discussed with the agency is that with the positive Phase II results in the trial, that was a 26-week trial that included both new onset and relapsing refractory patients.

The design of the [Phase III trial] could be as simple as a single Phase III clinical trial being pivotal for moving forward with the BOA. And the idea there is to make sure that we have a replication of data as well as a sufficient safety database with the 52 weeks of exposure according to ICH guidelines.

And then regarding the secukinumab data, yes, we're aware of the data and the recent presentation of the data, and they do appear to be a positive result, which is always good for patients. We believe that mavrilimumab, by targeting both TH1 as well as Th17-driven disease, especially the importance of GM-CSF, which is a -- I'm sorry, a gamma interferon, which is a Th1 cytokine and the pathophysiology of the disease could still be differentiating for mavrilimumab. Of course, that will depend upon the clinical results, but we're confident in our program going forward.

I think, we have some technical difference there. So at the next question, operator, still there?

Yes. And next, we have Jeff Meacham of BofA.

This is Jason on for Jeff. Question on the payer dynamics for ARCALYST, if you will. Can you help us understand kind of the current gross to net and where things are moving or at least evolving? To what extent was there patient assistance and how is that changing? And what are your expectations moving forward?

And then, if I may, on the patient disposition, where the majority of patients that were treated were these patients who were transitioning over from the clinical studies, were they sort of in the wings? Were these heavily refractory patients? Somewhat new? Any sort of color there would be very helpful.

Jason, this is Sanj. Maybe I'll make an opening comment and then Ross or Mark can jump in. But obviously, we're still in the early stages of launch. And as you can expect, gross to net is quite fluid at this stage. And so, we aren't providing any specific guidance or analysis on that. But I'll hand over to Ross and see, if he wants to be a bit more effusive, but that's where I'm at.

Yes. I think, you're absolutely correct, Sanj, we're not providing any specific guidance kind of moving forward on the gross to net side and pretty good. I guess the commentary that I can provide on that to help a little bit is that in Q3, we did benefit from the stronger-than-expected commercial payer mix, meaning a higher percentage of patients in the commercial insurance payer bucket as opposed to government insurance leading to less strategy discount.

So that was some favorability in Q3 related to that. And also, with lower co-pay utilization as well, meaning that we launched part of the way through the year in Q2. And actually, what we found is that many of the patients have already reached co-pay max prior to the ARCALYST prescriptions, so probably less support there around the co-pay than what we actually expected prior to launch as well.

So of course, this is very fluid at the time of launch. I'm sure things will see then normalize as the future quarters go on. I think, it's important to say that our Q4 guidance takes into account the early launch experiences and trends that we've seen. So we're confident we provided that guidance.

In terms of free goods, patient affordability and access is incredibly important to us under Kiniksa OneConnect, our patient services program, we do have different offerings for eligible patients, via patient assistance program, bridge for people who may be in between insurers and also a quick start program as well to help patients gain access to [loss] they're waiting for coverage determination for eligible patients.

So we're very keen on making sure that's available to patients as much as possible. But also it's worthwhile mentioning that the free goods are actually captured under our sales and marketing line and SG&A opposed to gross to net.

On the patient disposition part, the long-term extension transition really happened in the first quarter of launch as opposed to Q3. So really, we've seen that and what we announced in the prior earnings release is that around 70% of the U.S. patients on the long-term extension moved across to commercial coverage and commercial drug. So that's really already happened. So in Q3 and beyond now, this is new patients coming through to have ARCALYST prescribed for the first time.

We continue to be very focused on the 14,000 patients as refractory, the multiple relapsing and the steroid dependency patients, that's a core focus of our field-based team and everything that we do from a digital marketing perspective as well.

But we're also cognizant that the broad label that we achieved at the time of approval from the FDA was actually allows physicians the flexibility to prescribe what they really think it's going to help patients the best in recurrent pericarditis. So we'll continue to be focused on those patient groups. I guess, it's probably too early to kind of comment on exactly like how many patients they are within each of the buckets and so on, where we're just in the early stages of launch.

But very pleased with how it's being received out in the field, both with physicians and also payers and the number of patients. And we're very happy that we now have more than 200 physicians that have prescribed ARCALYST since the time of launch, which is a doubling of the first quarter launch numbers.

And we have David Nierengarten of Wedbush.

I had 1 -- 2, actually. One on the patients as the patients are coming in for ARCALYST in recurrent pericarditis, is there any information on kind of meantime since recurrent pericarditis diagnosis? I'm curious, if the patients coming in are really long-term patients, or are you starting to see some trends towards patients, who have been on therapy for a shorter period of time, other therapies for a shorter period of time?

And then my second question is on vixa, just on the recruiting of the Phase IIb. Is there any slowdown there? Are you on pace? Kind of how is that study going in the current environment for patient recruitment?

Thanks, David. Ross, do you want to take a crack and start on that, and I can just jump in on me and John can jump in for the vixa.

Yes, very happy to. David, thanks very much for the question. So in terms of the time of disease that the patients have had when we get prescribed ARCALYST, we really are not providing any metrics on that yet, just beIng at the very early stage of launches if that changes as time goes on. But I guess the best marker that I can provide right now is maybe 2 data points.

One is the natural history of recurrent pericarditis, where we see that, that shows a mean duration of recurrent pericarditis of around 2 years. And then, when you look at the more kind of severe, if you like, patient population, like what we saw in the RHAPSODY study, the mean duration for those patients had already been 2.4 years, and that was on entry into the trial.

So of course, it's highly variable dependent on the patient type and that really plays into our messaging around the duration of treatment and matching the duration of disease as well, and wanting to make sure patients help adequate duration to support through the underlying autoinflammation that they're ultimately suffering from.

Does that cover your question on David?

Yes, it does.

Yes. And maybe I'll start on vixa and, John, feel free to jump in. For vixarelimab, obviously, as I said, we're well on the way our dose ranging Phase IIb study, which we've said we expect data in the second half of next year. We continue to believe that prurigo nodularis is an area of significant unmet need, and it's obviously a devastating disease and currently no approved therapy. So that's obviously the backdrop.

The Phase IIb study is a 2-year global study driven by the 16-week time point, so which is the primary key efficacy endpoint. So what I can say at this point is enrollment is ongoing in the U.S., and we are starting up in Europe and Asia, and we expect to update in the second half. But we tend to execute very well. And I think maybe, John, if you've got any comments on the landscape or anything else on the trial?

No Sanj, I think you hit the nail on the head there in terms of the trial design. Maybe one last point about the endpoints. The primary endpoint is a 16-week endpoint, as you mentioned, driven by Worst-itch NRS. And then importantly, also, as a secondary efficacy endpoint is IGA 0 to 1 attainment, or clear or almost clear from the lesion side, given the data that we saw in the Phase IIa program, which showed a rapid reductions in Worst-Itch NRS as well as rapid resolution of lesions.

And next, we have Liisa Bayko of Evercore.

Great quarter. Two questions from me. The first one, just on rinolacept. Like how are you thinking about now what the duration of therapy is going to be? And it just helpful when we think about projecting beyond 2021. I know, there's a comment here that at the 1-year anniversary of the long-term extension, the median duration was 20 months, which is quite long. We now have prescriptions being written for 12 months.

Is it certainly beyond the kind of 6 to 9 months that was the initial kind of range of thoughts for duration? So is your thinking on duration evolving for 6 to 9 months? How would you help us think about that as we think about '22 and beyond?

Over to you, Ross.

Yes. Thank you, Sanj. Thank you, Liisa, thanks very much for the question. So regarding duration, I guess, we're still at the early stage. So it's difficult to know what the eventual duration is going to be. I wouldn't say, we're necessarily moving away from what we discussed previously, but just acknowledging that there are some unknowns, particularly as we go into Q4 now when we have a meaningful number of patients who were actually being reached in the 6- to 9-month mark.

So I think Q4 is going to be helpful and telling around the potential duration at that time point that you mentioned.

But outside of that, as we said, really, it's dependent upon the disease where the patients are in the duration of the course of the disease. You rightly said that we have 2 insights right now. One of those is the clinical trial insights of the long-term extension and the point there that we had on one of the slides.

And so you remember when we post out to the randomized withdrawal portion of the Phase III study, patients had the opportunity to go into the long-term extension portion of the study, and 74 out of 75 of those patients decided to continue on therapy. So remember, the randomized withdrawal was a median of 9 months. The long-term extension was up for an additional 24 months (inaudible) on the physician and patient requirements.

And earlier this year, we had a look at a snapshot to look at the 1-year anniversary of the start of the long-term extension study. And that showed that the median duration at that time point was 20 months in duration. The second insight is really the real world one that we mentioned around 2/3 of their prescribers right into 12 months, which just gives you maybe somewhat an indication on how physicians are thinking about it and the patients that they see.

But ultimately, it's going to depend on where they are the disease score as well as the willingness for patients to stay on a weekly regime therapy, as well as also the payer approval duration as well.

So I think there's a lot of uncertainties there. And obviously, kind of (inaudible) hopefully, that provides you a little bit of an insight into our thinking on it. I wouldn't say right now that we're moving away from what we've said previously, but time will tell here early in those.

Just as a follow-up to that, what is the -- like what are you seeing? I don't know, if you've done any kind of market research on this, but the trigger for stopping therapy for physicians?

Yes. So we haven't provided anything on that right now. John, I don't know whether you want to take over on that point and provide any extra context around ceasing treatment through kind of MRI, some of the academic work that's taken place around that, which might help. But outside of that, we haven't shown anything else there.

Sure, happy to help that. And Liisa, nice to speak with you again Right, so you raised an interesting question, which is how do physicians monitor patients understanding, as Ross said, that this is a -- it's a long-standing disease, right, and the epidemiology points to several years of duration.

And so you raised an interesting question, which is how does a physician know that when they're treating a patient chronically and they're doing well, that the underlying -- whether or not the underlying autoinflammation has resolved and it's safe to withdraw therapy.

And I think that's really where the clinical trials data are helpful because it showed that continued treatment resulted in continued clinical response as well as the fact that if the underlying disease is still present, premature cessation of treatment that really unmasks the underlying disease and causes results in pericarditis recurrence.

So in terms of some of the markers that the physician has, they really -- it's difficult to kind of look at a patient clinically and reach that conclusion. So there are 2 pieces of information that at least some of the expert cardiologists are using.

The first one is to look at the patient at the time that therapy is initiated, let's say, rinolacept therapy is initiated. And you see kind of where they are in their disease course and how long their disease has lasted up until that point. And the severity of the disease in terms of the density of the number of recurrences as well as some of the associated comorbidities.

That's one approach is looking at it at baseline. Another approach is to look at the patient while on therapy and there are imaging technologies have been shown to be helpful. Again, we've shown data on this point as well from the Cleveland Clinic data both from the Phase II study as well as the Phase III study.

And what that shows is that there's a phenomenon called delayed hyper enhancement, which is neovascularization of the [pericardium]. And that shows basically a substrate that can support inflammation. And when that delayed hyper enhancement, as it's called, is present, that could be an indicator of the fact that underlying autoinflammation is still present.

And so, what the data have shown is that cessation of therapy was associated with a higher burden of recurrence. And so those are the 2 factors that are currently available to clinicians to help define whether to continue with therapy. So I hope that's some helpful insights.

Very helpful. And then just a final question for me on vixarelimab. I know there was some data recently, the last week or so, for DUPI and PM. Maybe you could comment on that and how you see the competitive landscape evolving? As I understand, they also saw a resolution of lesions and a pretty nice NRS score. And are you thinking of that as some kind of temporary benchmark? Or how should we think about the DUPI data in the competitive landscape?

Sanj, would you like me to jump in?

Yes. Go ahead.

Okay, sure. So we're aware of the data. And what we see with the vixarelimab data is that they are pretty much consistent with what we've seen with other data from the dupilumab program, for example, in atopic dermatitis. As you know, dupilumab blocks Th2 inflammatory responses. And then, what we saw for atopic dermatitis and what we see also in prurigo nodularis is that there's a bit of a lag time on the first 3 inflammation resolves, which then results in reduction in the interleukin-31 levels. And so over time, we see a reduction in the pruritus scores. And similarly, over the course of the long-term trial that they showed, there was a gradual resolution of lesions.

So I think that it certainly is a helpful data set to see as consistent with what we've seen before. We believe vixarelimab is differentiated in this space because vixarelimab is blocking the action of interleukin-31 directly. And so that's the reason why we saw a much more rapid and more profound reduction in pruritus scores even in the early weeks after initiation of therapy.

And if you'll remember from our Phase IIa data, we saw nearly 1/3 of patients had achieved clear, almost clear, that was statistically significant at week 8, but it was also significant at week 6 with early curve separation as early as week 4. So I hope that's helpful comparison of the data understanding it's across trials.

And I see no further questions in the queue. So speakers, I will return the call back to you for closing comments.

Thanks, operator. So thanks, everybody, for joining in today. Obviously, a great quarter. A lot more to do. We're very excited about both ARCALYST as well as the pipeline, and we're going to crack on. Thank you. Bye-bye.

That will conclude today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.

Thanks, operator.

You're welcome.