Kiniksa Pharmaceuticals (KNSA) CEO, Sanj Patel on Q3 2021 Results - Earnings Call Transcript

Kiniksa Pharmaceuticals Ltd. (NASDAQ:KNSA) Q3 2021 Earnings Conference Call November 1, 2021 8:30 AM ET

Company Participants

Sanj Patel - Chairman, Chief Executive Officer

Ross Moat - Group Vice President, General Manager

Eben Tessari - Chief Business Officer

Mark Ragosa - Chief Financial Officer

John Paolini - Chief Medical Officer

Rachel Frank - Associate Director, Investor Relations

Conference Call Participants

Anupam Rama - JP Morgan

Paul Choi - Goldman Sachs

Jason - Bank of America

David Nierengarten - Wedbush

Liisa Bayko - Evercore

Operator

Good day and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals third quarter conference call.

At this time, all participants are on a listen-only mode. After the speakers’ presentation, there will be a question and answer session. To ask a question during that session, you will need to press star, one on your telephone. If you require any assistance during the call, please press star, zero.

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

Rachel Frank

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 and Media section.

As to 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.

Sanj Patel

Thanks Rachel. Good morning everyone. I’m happy to review our third quarter 2021 results today.

We continued 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 patient and physician 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 and COVID-19 related ARDS, and Eben 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 are well positioned for longer term growth.

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

Ross Moat

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 remained 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 one-third of the $7.7 million in Q2 to more than three-quarters of the $12.1 million of revenue in Q3. We are delighted with the growth rate and it represents continued uptake and adoption of Arcalyst from physicians, payors and patients in this previously unmet and debilitated ultra-inflammatory cardiovascular disease. Taking 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 are 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 are also starting to see an increase in prescribers who are writing 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 are achieving in excess of 80% of these prescriber interactions face to face. This highlights the favorable access we have to our target accounts as well as the eagerness of many physicians to learn about Arcalyst.

On the payor 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 to a finalized payor policy 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 pre-launch 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 payors will update their coverage policies within one year of launch, and additionally, whilst it’s still too early to provide definitive updates on duration of therapy, it’s important to state that so far, two-thirds of the Arcalyst prescriptions for recurrent pericarditis were written for 12 months of therapy. This is an excellent marker 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 payor approval duration.

When it comes to compliance, we are generally seeing the patients receive refills on time and that almost all of the patients who initiated Arcalyst in Q2 were 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 fall 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 treatment. In recent weeks, we initiated a tailored communication plan to this patient group designed to provide targeted information on recurrent pericarditis dependent 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 are currently on Arcalyst treatment 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 patients’ perspective on 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 for this disease and get back to their normal lives.

We are delighted with the Q3 results and we now have two strong foundational quarters from approval, and we look forward to continuing to deliver for patients in Q4 and beyond.

Eben, over to you.

Eben Tessari

Thanks Ross, and good morning everyone. I will provide a brief overview on where we stand with our three clinical stage programs, starting with vixarelimab.

We are currently enrolling a global randomized placebo-controlled Phase IIb dose ranging trial in prurigo nodularis, testing three different once-monthly dosing regimens. This is a first-in-class mechanism that targets OSMR-beta, which mediates the two key cytokines implicated in pruritis, hyperkeratosis, and fibrosis. The primary efficacy endpoint is change 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 pathology 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 I’ll walk through in the next two 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 hospitalizations has remained 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 variants 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 six months have seen 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 and 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, non-mechanically ventilated patients versus placebo. In August, we reported that overall survival in this same non-mechanically ventilated cohort of patients was carried out through Day 90. Those results demonstrate the persistence of a 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 had 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 on the first quarter of ’22.

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

Mark Ragosa

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 splits profit 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.

With that, I’ll turn the call back to Sanj for closing remarks.

Sanj Patel

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 validates 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 today in COVID-19 and GCA, vixa in prurigo nodularis, and KPL-404’s potential in 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.

With that, I want to thank you all for your time today, and I’ll turn the call back to the Operator.

Question-and-Answer Session

Operator

[Operator instructions]

Our first question comes from Anupam Rama of JP Morgan. Your line is open.

Anupam Rama

Hey guys, thanks so much for taking the question, and congrats on the quarter.

You guys noted that two-thirds of prescriptions for Arcalyst are being written for 12 months. For the other one-third, what type of duration are the prescriptions being written for, and are there any trends on the patient types that are getting a 12-month prescription versus another duration prescription? Thanks so much.

Sanj Patel

Ross, do you want to take that?

Ross Moat

Yes, happy to. Hi, and thanks very much for the question. Nice to speak to you again.

Yes, so two-thirds of the patients had prescriptions for 12 months duration, which is--you know, we were very pleased to see that because that’s a good insight into how physicians are thinking about the duration of therapy. For the remaining one-third, it was obviously not 12 months, so it really comes down to physicians and how they’re expecting to see patients again in their follow-up clinics, so outside of those two-thirds there would be prescriptions there that would be for three months or for six months. That doesn’t necessarily interpret into what they expect the duration of therapy to be but could moreover be expecting to see the patient again, reassessing the baseline and really understanding the treatment duration from there, and just making sure that they have that follow-up with the patient. Particularly as physicians are obviously new to Arcalyst, many of these physicians are prescribing for the first time, so they might want a closer patient follow-up than may happen in the longer term. Hopefully that answers that part of it.

In terms of patient trends and patient types, I think at the moment there are such low numbers in the early stages of launch that it’s difficult to correlate which patients are getting what disease and which duration. I think that’s difficult to answer right now and I’m not sure there is a correlation there, but broadly speaking we see two different types of patients. We see patients coming through that are clinically stable, so that patient’s either coming from our long term extension study or they’re coming from chronic steroids, and then we see patients that are acutely symptomatic, really suffering from the disease and really seeking a targeted treatment, so that’s two main categories of patients that we’re seeing. But of course, there’s the duration question even though that’s what’s being prescribed, it doesn’t necessarily mean that that’s what the actual eventual duration is going to be. The duration of treatment ultimately will depend on the duration of the disease and also where patients are in the disease course as well.

What we do is know is that continued treatment results in 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 tell what the actual eventual average duration is going to be in the midterm, and we look forward to reporting that in time to come.

Anupam Rama

Thanks so much for taking our questions.

Operator

Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi

Thank you very much for taking our questions, and let me add my congratulations on the quarter as well. My first question is on commercial. With regard to as you go into see doctors here, can you maybe just comment on what factors are being cited 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 clarification?

Ross Moat

I’m happy to take that question as well - hi Paul, thank you very much for that.

In terms of the headwinds or barriers or hesitancy there for doctors to prescribe, this is just--you know, it’s 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’re doing on the early stages of treatment.

Outside of that, we don’t necessarily see hesitancy from healthcare professionals. It’s just more they’re 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 [indiscernible] treatment and the first [indiscernible] treatment that’s approved now for recurrent pericarditis, and we’re having very successful meetings with physicians, and when patients do come through, we think we’ll continue to see the uptake in prescribing.

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 payor 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 payor coverage in place much more broadly now with more than 190 million lives covered across the U.S., hopefully that will also provide lots of confidence for physicians as well as speed up the time to approval and get patients onto therapy as quickly as possible.

Paul Choi

Okay, thanks Ross, that’s helpful. Then I think this question is on the pipeline, so maybe for Eben. 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? Thank you very much.

Sanj Patel

Thanks Paul, this is Sanj. Maybe the question would be better directed to John, but I’ll make a few comments. Obviously we’re very pleased with the Phase II results that we had in GCA and really showed a potential for true differentiation there. We have not disclosed or commented for our 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 on potential trial designs. John, over to you.

John Paolini

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 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 or relapsing refractory patients, that the design of the Phase III, it could be as simple as a single Phase III clinical trial, being pivotal for moving forward with a BLA. The idea there is to make sure that we have replication of data as well as a sufficient safety database with 52 weeks of exposure, according to ICH guidelines.

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 GMCSF, which is a--I’m sorry, gamma interferon, which is a TH1 cytokine in 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.

Sanj Patel

I think we’re having some technical difficulties. Should we move onto the next question, Operator, if you’re still there?

Operator

Yes, thank you. Next we have Geoff Meacham of BoA. Your line is open.

Jason

Good morning everyone. This is Jason on for Geoff. Thanks so much for taking our questions and for the great quarter.

A question on the payor dynamics for rilonacept, 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? Then if I may, on the patient disposition, were 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. Thanks so much.

Sanj Patel

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

Ross Moat

Yes, I think you’re absolutely correct, Sanj. We’re not providing any specific guidance moving forward on the gross to net side and free goods. 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 payor mix, meaning a higher percentage of patients in the commercial insurance payor buckets opposed to government insurance leading to less statutory discounts, so there was some favorability in Q3 related to that, and also with lower copay 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 had already reached their copay maxes applied to the Arcalyst prescriptions, so probably less supports there around the copay than what we actually expected prior to the launch as well. Of course, this is very fluid at the time of launch, and I’m sure things will season and 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 comfortable in providing that guidance.

In terms of free goods, patient affordability and access is incredibly important to us. Under Kiniksa One Connect, our patient services program, we do have different offerings for eligible patients, our 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 whilst 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 in 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, opposed to Q3, so really we’ve seen that, and what we announced in the prior earnings release, it was 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, so that’s a core focus our fill base team and everything that we do from a digital marketing perspective as well, but we’re also cognizant of the broad label that we achieved at the time of approval from the FDA, which actually allows physicians the flexibility to prescribe where they really think it’s going to help patients the best in recurrent pericarditis, so we continue to be focused on those patient groups.

I guess it’s probably too early to kind of comment on exactly how many patients there are within each of the buckets and so on - we’re just in the early stages of launch, but very pleased with how it’s been received out in the field, both with physicians and also payors 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.

Jason

Got it, thank you so much.

Operator

Thank you. Next we have David Nierengarten of Wedbush. Your line is open.

David Nierengarten

Hey, thanks for taking the question. I have two, actually, one on the patient--you know, as the patients are coming in for Arcalyst in recurrent pericarditis, is there any information on mean time 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.

Then my second question is on vixa, just on the recruiting for the Phase IIb, is there any slowdown there, or are you on pace? How is that study going in the current environment for patient recruitment? Thanks.

Sanj Patel

Thanks David. Ross, do you want to take a crack at starting that and I can always jump in, or me or John can jump in for the vixa.

Ross Moat

Yes, very happy to. Hi David, thanks very much for the question.

In terms of the time of disease that the patients have had when they get prescribed Arcalyst, we really are not providing any metrics on that yet, just being at the very early stage of launch versus that changes as time goes on, but I guess the best marker that I can provide right now is maybe two data points. One is the natural history of recurrent pericarditis, where we see that that shows a mean duration of recurrent pericarditis of around two years, and then when you look at the more severe, if you like, patient population like 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 naturally the duration of disease as well, and wanting to make sure patients have adequate duration to support through the underlying auto inflammation that they’re ultimately suffering from.

Sanj Patel

Does that cover your question on Arcalyst, David?

David Nierengarten

Yes, it does. Thanks.

Sanj Patel

Good, and maybe I’ll start on vixa, and John, feel free to jump in. Vixarelimab, obviously as I said, we’re well underway with our dose ranging Phase IIb study, which we’ve said we expect data on the second half of next year. We continue to believe that prurigo nodularis, there is a 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 two-year global study driven by the 16-week time point, which is the primary key efficacy endpoint, so all 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 have data in the second half.

But you know, 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?

John Paolini

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 IRS, and then it importantly also--you know, as a secondary efficacy endpoint, is IGA 0/1 attainment or a clear or almost clear from the lesion side, given the data that we saw in the Phase IIa program, which showed rapid reductions in worst itch NRS as well as rapid resolution of lesions.

David Nierengarten

Got it, thank you.

Operator

Thank you. Next we have Liisa Bayko of Evercore. Your line is open.

Liisa Bayko

Hi, thanks for taking the question, and great quarter.

Two questions for me, the first one just on rilonacept. How are you thinking about now what the duration of therapy is going to be, and it’s just helpful when we think about projecting beyond 2021, I know there’s a comment here at the one-year anniversary of the long term extension, the median duration was 20 months, which is quite long. You now have prescriptions being written for 12 months - this is certainly beyond the six to nine months that was the initial range of thought for duration, so is your thinking on duration evolving from six to nine months? How would you help us think about that as we think about ’22 and beyond?

Sanj Patel

Over to you, Ross.

Ross Moat

Yes, thank you Sanj. Hi Liisa, thanks very much for the questions.

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 are actually reaching the six to nine month mark, so I think Q4 is going to be helpful and telling around the potential duration of that time point that you mentioned.

But outside of that, as we said, it’s dependent upon the disease, where the patients are in the duration of course of the disease. We have two insights right now - one of those is the clinical trial insight of the long term extension, and the point there that we had on one of the slides is that you’ll remember when we closed out 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 nine months, and the long term extension is up for an additional 24 months depending on the physician and patient requirements. Earlier this year, we had a look at--a snapshot look at the one-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’ve mentioned around two-thirds of the prescribers writing for 12 months, which just gives you maybe some indication on how physicians are thinking about it in the patients that they’re seeing. But ultimately, it’s going to depend on where they are in their disease course as well as the willingness for patients to stay on a weekly regime therapy, as well as also the payor approval duration as well. I think there’s a lot of uncertainty there, but hopefully that provides you a little bit of an insight into our thinking on it. I won’t say right now that we’re moving away from what we’ve said previously, but time will tell [indiscernible].

Liisa Bayko

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

Ross Moat

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 [indiscernible] MRI, some of the academic work that’s taking place around that, which might help. But outside of that, we haven’t shared anything else.

John Paolini

Sure, happy to help out, and Liisa, nice to speak with you again.

You raise an interesting question, which is how do physicians monitor patients, understanding as Ross said that this is a--you know, it’s a longstanding disease and the epidemiology points to several years of duration. So you raise 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 auto inflammation has resolved and it’s safe to withdraw therapy. 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 really unmasks the underlying disease and causes or results in pericarditis recurrence.

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 two 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 rilonacept therapy is initiated, and you see 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 co-morbidities. That’s one approach, is looking at it at baseline.

Another approach is to look at the patient while on therapy, and there imaging technologies have been shown to be helpful. Again, we’ve shown data on this point as well from the--the Cleveland Clinic has shown 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 a 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 the 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.

Those are the two factors that are currently available to clinicians to help define whether to continue with therapy, so I hope that’s some helpful insights.

Liisa Bayko

Very helpful, thanks a lot. Then just a final question from me on vixarelimab, I know there was some data recently, over the last week or so, for dupi and PN. 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 the dupi data in the competitive landscape? Thanks.

John Paolini

Sanj, would you like me to jump in on that?

Sanj Patel

Yes, go ahead.

John Paolini

Okay, sure. We’re aware of the data and what we see with the dupilumab data is that they’re 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 is a bit of a lag time, that first the inflammation resolves which then results in reduction of the interleukin-31 levels, and so over time we see a reduction in the pruritis scores. 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 dataset to see and 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 pruritis scores even in the early weeks after initiation of therapy. If you’ll remember from our Phase IIa data, we saw nearly a third of patients had achieved clear or 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.

I hope that’s a helpful comparison of the data, understanding it’s across trials.

Liisa Bayko

Great, thank you very much.

Operator

Thank you. I see no further questions in the queue, so speakers, I return the call back to you for closing comments.

Sanj Patel

Thanks Operator. 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.

Operator

This does conclude today’s conference call. Thank you all for participating. You may now disconnect and have a pleasant day.