Kiniksa Pharmaceuticals International Q2 2025 Earnings Report

Kiniksa Pharmaceuticals International EPS Results

• Actual EPS: $0.23
• Consensus EPS: $0.18
• Beat/Miss: Beat by +$0.05
• One Year Ago EPS: N/A

Kiniksa Pharmaceuticals International Revenue Results

• Actual Revenue: $156.80 million
• Expected Revenue: $145.21 million
• Beat/Miss: Beat by +$11.58 million
• YoY Revenue Growth: N/A

Kiniksa Pharmaceuticals International Announcement Details

• Quarter: Q2 2025
• Date: 7/29/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, July 29, 2025
• Conference Call Time: 8:30AM ET

Kiniksa Pharmaceuticals International (NASDAQ:KNSA), Inc. is a biopharmaceutical company focused on discovering, acquiring and developing therapeutics for patients suffering from lifethreatening and debilitating immune-mediated diseases. Founded in 2013 and headquartered in Lexington, Massachusetts, Kiniksa applies a patient-centric approach to build a diversified portfolio of marketed medicines and clinical-stage candidates targeting inflammation and immunology. The company’s core mission is to address complex conditions with significant unmet medical needs by advancing both novel and differentiated therapies.

The company’s lead marketed product is Ilaris (canakinumab), an interleukin-1β blocker licensed for the treatment of cryopyrin-associated periodic syndromes, systemic juvenile idiopathic arthritis, adult-onset Still’s disease and Schnitzler syndrome. Beyond Ilaris, Kiniksa’s clinical pipeline includes mavrilimumab, a monoclonal antibody targeting the GM-CSF receptor being investigated for giant cell arteritis; remibrutinib, a selective BTK inhibitor in Phase III studies for chronic spontaneous urticaria; and pozelimab, an anti-C5 monoclonal antibody under development for rare complement-mediated disorders such as paroxysmal nocturnal hemoglobinuria and myasthenia gravis.

Kiniksa operates globally, with commercial and development activities spanning North America, Europe and Asia under various licensing and distribution arrangements. The company is led by Founder and Chief Executive Officer John H. Johnson, who oversees a management team composed of experienced biopharmaceutical executives and scientific leaders. By combining strategic partnerships, disciplined capital allocation and a targeted R&D strategy, Kiniksa aims to deliver therapies that can transform the treatment landscape for patients with serious immune diseases.

Kiniksa Pharmaceuticals International Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Arcelis net revenue reached $156.8 million in Q2—a 52% year-over-year increase and over $1 billion in cumulative sales—leading to raised 2025 guidance of $625 million–$640 million.
• Positive Sentiment: Conexa reported net income of $17.8 million versus a $3.9 million loss a year ago, with operating expenses up 26% and cash balance increasing by $40 million to $307.8 million.
• Positive Sentiment: The Phase 2/3 trial of KPL-387 in recurrent pericarditis has been initiated, with patient recruitment underway and pivotal data expected in the second half of 2026.
• Positive Sentiment: The Arcelis prescriber base grew to over 3,475 physicians, active patient penetration in multiple recurrence rose to 15%, and payer approval rates remained above 90%.

Presentation

[Operator]

Thank you for standing by and welcome to the Kiniksa Pharmaceuticals International second quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press Star one one on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press Star one one again. As a reminder, today's program is being recorded. Now I'd like to introduce your host for today's program, Jonathan Kirshenbaum, Investor Relations. Please go ahead, sir.

[Jonathan Kirshenbaum, Investor Relations at Kiniksa Pharmaceuticals International]

Thank you. Operator, good morning everyone and thank you for joining Kiniksa's call to discuss our second quarter 2025 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investors section. As for the agenda for today's call, our Chief Executive Officer, Sanj K. Patel, will start with an introduction and overview of our business. Ross Moat, Kiniksa's Chief Commercial Officer, will provide an update on ARCALYST commercial execution. Mark Ragosa, our Chief Financial Officer, will review our second quarter 2025 financial results. Finally, Sanj will share closing remarks and kick off the Q and A session for which John F. Paolini, our Chief Medical Officer, and Eben Tessari, our Chief Operating Officer, will also be on the line.

[Jonathan Kirshenbaum, Investor Relations at Kiniksa Pharmaceuticals International]

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, CEO at Kiniksa Pharmaceuticals International]

Thanks Jonathan and good morning everyone. I'm happy to review Kiniksa's second quarter financial results and the highlights across our portfolio. Kiniksa continues to build upon the strength across our business which is driven by both our commercial execution with ARCALYST and our pipeline development programs including KPL-387. ARCALYST continues to generate strong revenue growth. Our continued execution across key commercial drivers and increased penetration across the recurrent pericarditis population led to a net revenue of $156.8 million in the second quarter. This represents a growth of $19 million over the first quarter in just over four years since the launch of ARCALYST as the first and only FDA-approved therapy for recurrent pericarditis. Kiniksa has generated over $1 billion in cumulative net sales.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Surpassing this milestone is a result of our effective commercial strategy and our team who work relentlessly to bring this highly efficacious therapy to thousands of patients suffering from this debilitating disease. Kiniksa is well positioned to continue maximizing the potential of ARCALYST for full year 2025. We're raising our ARCALYST net sales guidance to between $625 million and $640 million, from $590 million-$605 million. Importantly, growing ARCALYST revenue continues to support our robust balance sheet, providing capacity for continued investment in value creating opportunities across the business without the need to access the capital markets. Turning to our pipeline, we've now initiated and have begun recruiting in the Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis. This next slide highlights the design of the Phase 2/3 clinical trial.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

In designing this study, we've leveraged our experience with RHAPSODY, which was the successful Phase 3 pivotal trial supporting FDA approval of ARCALYST in recurrent pericarditis. This study consists of three overlapping parts which have been combined into a single protocol, the Phase 2 dose focusing portion, the Phase 3 double-blind placebo-controlled pivotal portion and the long-term extensions. We're now recruiting patients in the dose focusing portion of the study and expect data in the second half of next year. From there we'll continue to move as fast as possible and our goal is to deliver this treatment option to patients in the 2028-2029 time frame. Thanks to the excellent work of our teams. Kiniksa is the leader in recurrent pericarditis. Importantly, we are committed to driving additional innovation for these patients and maintaining our leadership position. Our physician and patient market research shows an IL-1α/β inhibitor with.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

The target profile of KPL-387 could be a meaningful treatment option for patients with recurrent pericarditis. Specifically, the potential for a once-monthly dosing of a liquid formulation in an autoinjector could drive further adoption as well as potentially enhance both duration and compliance. We continue to make solid progress in the second quarter both commercially and clinically, and we continue to crack on across the portfolio. With that, I'll turn it over to Ross.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Thank you Sanj. Strong execution in Q2 led to significant revenue growth to $156.8 million, representing a 52% year-over-year increase compared to Q2 of last year. This performance was driven by expansion in both the breadth and depth of the prescriber base, which led to the highest number of quarterly new patient enrollments since launch and resulted in a substantial increase to our active commercial patients. Additionally, we've seen good persistence from the Medicare Part D patients who transitioned to commercial therapy at the start of the year due to the affordability changes associated with the Inflation Reduction Act. We are seeing this patient cohort follow similar metrics to other groups of patients on ARCALYST and while the one time bolus of patients observed in Q1 will not repeat, we have seen an increase in new Medicare Part D patients initiating commercial therapy versus the previous years.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

As a result of the increase in active patients, our penetration into the multiple recurrence population increased from approximately 13% at the end of last year to approximately 15% at the end of Q2. Ultimately, this growth reflects that patients and healthcare professionals continue to report high degrees of satisfaction with ARCALYST and we built a robust foundation of commercial fundamentals. For example, in Q2 our payer approval rates remained greater than 90%, total duration of therapy was approximately 30 months on average, patient compliance with therapy remained strong over 85%, and we continue to see ARCALYST used earlier in the course of the disease. Importantly, our strong Q2 performance highlights the progress we've made, but more importantly, we continue to be even more excited about the significant opportunity ahead with ARCALYST.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

On this slide I'm going to highlight how ARCALYST has continued to shift the treatment paradigm to become the standard of care for recurrent pericarditis. Our promotional efforts have been focused on educating patients and healthcare professionals to recognize recurrent pericarditis as an interleukin-1 alpha and beta mediated disease best managed with targeted immunomodulation. Since launch, we've seen continuous robust increases in both the new and repeat prescribers every single quarter. This growth not only speaks to the effectiveness of our educational efforts, but it also illustrates how receptive physicians have been to this evolved paradigm that utilizes a targeted, highly efficacious and well-tolerated treatment. In Q2, more than 325 additional healthcare professionals wrote their first ARCALYST prescription, representing one of the highest quarter-on-quarter increases to date and bringing the total number of prescribers to more than 3,475.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Additionally, repeat prescribing also continued to increase with more than 120 ARCALYST prescribers writing for their second patient. Finally, we've also seen an increase in prescribing earlier in the disease; of all the patients on ARCALYST, around 20% were prescribed ARCALYST while on their first recurrence and roughly 80% when they had two or more recurrences. This highlights the growing physician appreciation for the value ARCALYST provides in preventing their patients from suffering future flares. In addition to more patients receiving ARCALYST at every stage of the disease, there has been a marked increase in the number of dedicated pericardial disease centers where patients are able to access expert care from healthcare providers well-versed in their disease. We have sponsored the AHA's Addressing Recurrent Pericarditis initiative as part of our ongoing efforts to shorten the treatment journey for patients by providing expert care close to home.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

There are also several more dedicated pericardial clinics outside of this initiative and our aim is to continue supporting this growth to help patients gain an earlier diagnosis and appropriate treatment of their disease. As the treatment approach continues to change across the country, there's a growing body of published literature recommending IL-1 pathway inhibitors such as ARCALYST to be used ahead of corticosteroids, which is well aligned with our commercial positioning of ARCALYST. Furthermore, looking at data from RESONANCE, our real-world evidence disease registry, which is driven by expert pericardial centers across the country, ARCALYST has increasingly become the second-line treatment choice after NSAIDs and colchicine. In Q2 we delivered $156.8 million in net revenue as well as increased the franchise profitability.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

As a result, we are pleased to increase our 2025 net revenue guidance by $35 million between the midpoints of the prior range and of the new range. This takes us from expecting between $590 million-$605 million to now expecting between $625 million and $640 million. This guidance indicates year on year net revenue growth of $215 million at the midpoint compared to full year 2024. This would be the highest annual increase in net revenue to date. As you can hear, we're excited about the future of ARCALYST as well as the progress of our pipeline. We are determined to bring future launches of novel therapies to patients who are suffering from debilitating diseases. With that, I'll turn the call over to Mark to discuss our financial results.

[Mark Ragosa, CFO at Kiniksa Pharmaceuticals International]

Bob, thanks Ross. This morning I will cover our second quarter 2025 financial performance. You can find our detailed financial information in today's press release. There are a few items I'd like to call your attention to. First, starting with our income statement on the left hand side of the slide, ARCALYST revenue grew 52% year-over-year in the second quarter to $156.8 million, driven primarily by strong growth in new patient enrollments, prescribers, and active commercial patients. Operating expenses grew 26% year over year in the second quarter, driven primarily by cost of goods sold and collaboration expenses from continued ARCALYST revenue growth and SG&A in support of ARCALYST commercialization. Lastly, due to strong revenue growth coupled with more moderate expense growth, net income was $17.8 million in the second quarter compared to a net loss of $3.9 million a year ago.

[Mark Ragosa, CFO at Kiniksa Pharmaceuticals International]

The right hand side of the slide provides the calculation of ARCALYST's collaboration profit, which grew 75% year over year in the second quarter to $104.8 million, driven by sales volume and disciplined commercial investment. At the bottom of this slide, our cash balance increased by approximately $40 million to $307.8 million in the second quarter and we continue to expect our current operating plan to remain cash flow positive on an annual basis. As you've heard from Sanj and Ross, both commercial and clinical execution in the second quarter added to Kiniksa's significant momentum across its business. Combined with financial discipline and a strong balance sheet, Kiniksa remains well positioned to continue to help patients as well as to create additional value in both the near and long term. With that, I'll turn the call back to Sanj for closing remarks.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Thanks, Mark. As you've heard, Kiniksa continues to execute both clinically and commercially and is well positioned to build significant future value. We are dedicated to helping as many patients as possible with ARCALYST and to advancing the development of our clinical portfolio, which includes KPL-387, the liquid formulation IL-1α/β inhibitor, which has a target profile of monthly dosing. Our ultimate goal is to bring additional treatment options and therapies to patients suffering from debilitating diseases with unmet need. I'll now turn the call back to the operator for questions. Thank you.

[Operator]

Certainly. Our first question for today comes from the line of Anupam Rama from JPMorgan. Your question please.

[Anupam Rama, Analyst at JP Morgan]

Hey guys, thanks so much for taking the question and congrats on the quarter. I know you highlighted 15% penetration into the multiple multiple recurrence setting at the end of 2Q. Wondering if you could provide some commentary on kind of the trends that you're seeing in the first recurrence setting. I think the slide said about 20% of total prescriptions are coming from this setting. Thanks so much.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Yeah, thanks very much. Anupam, this is Ross, thank you for the question. You're right that in the 2+ recurrence group, as a reminder, that's the 14,000 patient population in any given year. We've seen continuous increase since the launch into the penetration into that group, most recently going to 15% versus last reported at the end of 2024 of 13%. Seeing some nice increase within that group, and that remains our key target base. That's the patient group who are suffering the most, had the highest burden of the disease, and also most closely aligned with the data in RHAPSODY as well. We've also seen, as the treatment paradigm has changed over time, significant growth earlier on in the disease. Those patients are still very much within label, with the broad label that we have just for recurrent pericarditis, agnostic to the number of flares.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

There's an additional group of 26,000 patients in that first recurrence group, which is a significant opportunity for us. I think what we're seeing now with around 20% of all the ARCALYST patients that were prescribed the drug when they were on their first recurrence is greater confidence, familiarity, knowledge of how to prescribe, how to look after patients while they're on ARCALYST, and just greater comfort overall for healthcare professionals having greater experience with the drug and having seen the impact that it has on patients in the real-world setting to utilize this drug earlier on in the disease. I think, as well as an increase in understanding that recurrent pericarditis is a disease which is mediated by interleukin 1 alpha and beta, and in order to control that disease and prevent future flares, patients having to needlessly suffer those future flares.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

The utilization of an inhibitor of interleukin 1 alpha beta that's very well tolerated with high efficacy is being very well received by both patients and healthcare professionals. We are pleased to see an increase across really the whole population, which is a total of 40,000 patients in totality when you include the first recurrence on top of the 2+ recurrence groups.

[Anupam Rama, Analyst at JP Morgan]

Thanks so much for taking our question.

[Operator]

Thank you. Our next question comes from the line of Jeff Meacham from Citi. Your question, please.

[Geoff Meacham, Managing Director at Citi]

Hey guys, thanks for the question. I just want to follow up on Anupam's question. When you look at the patients who've dropped off maybe over, say, the past year or so, was the dosing frequency a big driver? I'm trying to get a sense for what the new start outlook could be for KPL-387, and I'm under the assumption that you'll have a pretty good switch rate as well, looking from ARCALYST. Thank you.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Thanks, Jeff. We're seeing the patients continuing to stay on therapy for quite some time. We've seen an average of 30 months in total. Patients are also pretty compliant to therapy overall at 85% or more. Patients are reacting very well while on ARCALYST. We're pleased about that, and we believe that there's a significant opportunity ahead for ARCALYST as we continue to switch on more and more physicians. When you take the penetration numbers of 15%, I think that shows that we've had good growth up until this moment in time. The opportunity ahead is significant, and that's without taking into account the first recurrence patients. We're very focused on continuing the growth of ARCALYST. Maybe our partnership.

[Geoff Meacham, Managing Director at Citi]

Pause there. Sanj, do you want to comment on KPL-387?

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Yeah, no thanks, Jeff. I mean, obviously we're very excited about KPL-387 and we are definitely cracking on as far as the Phase 2/3 study is concerned.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Obviously, that will be data dependent, but clearly we've shown we know how to commercialize in this space. We've developed an awful lot of great contacts and relationships with physicians. That'll be key, but ultimately depending on data we certainly know how to do as I said, we've. Leveraged a lot of the learnings we had from RHAPSODY and from ARCALYST earlier on. We'll continue to keep working on.

[Geoff Meacham, Managing Director at Citi]

Okay, thanks guys.

[Operator]

Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question please.

[Paul Choi, Executive Director at Goldman Sachs]

Hi, thanks everyone. Good morning and congrats on the quarter. My first question is, just given the pace of growth here, how do you think about potentially. Further expansion of the sales force or, you know, some sort of larger. Form of marketing DTC to continue expand awareness and drive penetration. My second question is with 3. 8, 7. You know, how are you thinking about potential in-office utilization in the future as part of the paradigm? Do you envision this potentially? Being more administrative in office and just how you're thinking about self administration versus physician administration down the road here? Thank you very much.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Thanks, Paul. This is Sanj.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Maybe I'll make a few comments and pass over to Ross if there's anything to add. Yes, very excited about the growth that we've had in ARCALYST without a doubt. As far as the sales force is concerned, obviously we've always said we do an awful lot of analytical work on what the right sizing is, looking at the territories. We've done that, as you know, since launch just over four years ago. As you've heard in the past, we have increased that. At the moment, really, we've not made any comments as to exactly what we've done on the size of it. Last reported was around 85. We're certainly continuing to look at what's needed as far as growth is concerned. I think they're being utilized incredibly well. As far as DTC and other things, clearly our marketing groups had a great impact in the launch so far.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

We certainly don't rest on our laurels. We're certainly looking at, in addition to what we've done as far as the sales force is concerned and our existing materials and disease education, physician education. We continue to look at other ways. I'm sure Ross can go into more detail, but we've certainly got a massive focus on digital marketing and looking at other ways. We can really apply sort of not just the metrics, but also some of the new technologies that are out there to identify patients that were very much in need. It's a very exciting area for us. As you can see, it's still growing. There's an awful lot more we can do. We certainly are tapping into that in the future. Maybe, Ross, you can comment on how we're looking at marketing and expanding our efforts.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Yeah, absolutely. Thanks, Sanj. Thank you, Paul. I think the key thing here on top of what Sanj said is we are an organization that never rests on our laurels. We're quite happy with how the launch has gone to date, but we have so much more to do as an organization. Yes, we could be very innovative in our approach, constantly evolving and refreshing what we do and finding better ways of doing things. As we get more and more into this market and increase our understanding of the market, we find that we can get more effective over time as we just have greater understanding. The utilization of newer technologies is also important to us. We have looked at utilizing AI-driven targeting in our strategy and in a variety of different digital marketing environments, and that's proven very successful for us.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

We haven't shared great detail on that, but we're utilizing a lot of new technologies now, which is really paying dividends and helping us to get out there to physicians and to patients and making a difference in this marketplace. We constantly evolve and look at new ways of doing things to get better and better over time. To the second part of your question, Paul, regarding in office versus outpatient use. The vast majority of our list is in outpatients under pharmacy benefits with KPL-387. Obviously, as Sanj said, everything is data dependent and we'll see as we progress further.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

With a target profile of monthly and in a liquid formulation with the potential to go to an autoinjector, that also plays nicely into where the patients are, which is, you know, ultimately not wanting to be in hospital suffering from this disease, but being treated appropriately and kept at home and preventing flares and preventing them going into hospital for the future. Whether that precipitates a change in kind of in office versus outpatients and, you know, patient administered in their own home is to be seen. We don't see a substantial call for, you know, in hospital utilization. Okay, great.

[Paul Choi, Executive Director at Goldman Sachs]

Thank you for taking our questions.

[Operator]

Thank you. Our next question comes from the line of Eva Fortea-Verdejo from Wells Fargo. Your question please.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Good morning. Congrats on the quarter and thanks for taking our questions. Two quick ones from us. On ARCALYST, from the 30-month average therapy duration, can you give us a sense in terms of numbers on how you are seeing a shorter treatment duration to patients in first recurrence versus patients in second and beyond? The second question is on KPL-387. Can you discuss how you're thinking about the balance between remaining cash flow positive on an annual basis and initiating studies in new indications beyond recurrent pericarditis? Thanks.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Thanks, Eva. Thank you very much for the question. I'll certainly take the first part and then hand over to someone else to cover the second part. We're not really seeing any meaningful differences in terms of duration from the different cohorts, including patients on a first recurrence versus second, third, fourth, fifth recurrence groups.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

Of course, the data is always evolving and building, and as more patients are starting to be initiated on ARCALYST earlier on in the disease, we just don't have some of that data yet. It will build and we'll report as we see it later down the line. From what we see so far, no significant differences. The average is 30 months. The median of the initial duration of therapy is around 17 months and the restart rates remain around 45%. Importantly, of all those patients that started ARCALYST in our launch quarter back in Q2 of 2021, now around 10% of all of those patients that started way back then are still on therapy, meaning their initial treatment of therapy and have just stayed on throughout, which I think is testament to the effect and how well tolerated ARCALYST can be for many of these patients.

[Ross Moat, Chief Commercial Officer at Kiniksa Pharmaceuticals International]

No significant differences to date. Obviously, this is something that we will keep an eye on and report as we see.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

As far as your second question regarding cash flow and further investment, I think at this point in our life cycle we are focused on continuing to create value. Importantly, as we've talked about in the past, we do think that through commercial execution and continued financial discipline we do have the capacity to continue to create value across our business, whether it's to further maximize the opportunity with ARCALYST, to further advance our pipeline, and or to pursue strategic initiatives.

[Eva Fortea-Verdejo, VP and Equity Research Analyst at Wells Fargo Securities]

Got it. Thanks.

[Operator]

Thank you. As a reminder, ladies and gentlemen, if you do have a question at this time, please press star 11 on your telephone. Our next question comes from the line of Roger Song from Jefferies. Your question, please.

[Roger Song, Analyst at Jefferies]

Great, congrats for the call and thank you for taking our question. Maybe two quick ones for the pipeline. The first one, KPL-387. Understanding you are doing the Phase 2 portion to define, just curious about what is the target efficacy and safety profile, particularly in the context of comparison to ARCALYST. You can make a decision to decide a dose and how likely you will move multiple doses into the Phase 3 portion, something like induction maintenance. Then a quick one for the KPL-1161. I'm enabling right now, and then what's the current thinking about potential indication for this quarterly. Thank you.

[John Paolini, Chief Medical Officer at Kiniksa Pharmaceuticals International]

Thanks for that question. Actually, both those questions. Regarding the profile of KPL-387, what we're looking for in the dose focusing portion of the trial is to select the dose that we'll use in the pivotal portion of the trial. In that sense, the ability to treat the acute flare as it happens and then prevent the subsequent flare is really the profile that we established with ARCALYST, and we're looking for a similar profile, if you will, with regard to the KPL-387 efficacy. Once we've selected that dose, we then carry that forward into the randomized withdrawal portion, pivotal section of the trial, which bears remarkable similarity in terms of its design and in terms of the endpoints that we have structured. At that point, it will be data driven in terms of what the actual profile of KPL-387 is.

[John Paolini, Chief Medical Officer at Kiniksa Pharmaceuticals International]

We're very confident in the study design as being able to show the strength of KPL-387 and its target profile. Of once-monthly dosing. Regarding the second question of KPL-1161, at this point we've not announced any specific indication. We realize that there's broad potential of having an IL-1α/β inhibitor pathway inhibition, if you will, that has a target profile of dosing every three months. That really opens the possibility of a range of chronic lifelong diseases that are autoinflammatory. We'll continue to do that work, but in the meantime our focus is on the IND enabling studies so that we can begin the first human study as soon as possible. Thank you so much.

[Roger Song, Analyst at Jefferies]

Thank you.

[Operator]

Thank you. Our next question comes from the line of David Nierengarten from Wedbush Securities. Your question please.

[David Nierengarten, Senior Analyst at Wedbush]

Hey, thanks for taking the question. I had two and maybe one is kind of a follow up to the last one. Is there any specific kind of efficacy boundaries that you're looking for out of the 387 study? Of course, ARCALYST showed near 100% drop off in recurrences. Is that the kind of efficacy bar we should be thinking about or could it be a little bit lower because of the more convenient dosing? I had another question on just emerging competition. There's a potential oral competitor out there that's going to report out data this half. Is there any thinking on that or any thoughts on how we should think about the potential competition emerging? Thanks.

[John Paolini, Chief Medical Officer at Kiniksa Pharmaceuticals International]

Thanks, David. Appreciate the questions. Regarding the efficacy profile in the Phase 2 studies, the dose focusing portion, we're really looking across a range of different dose levels in order to understand the performance characteristics of KPL-387. In that sense, we intend to use the totality of the data in order to define the dose level that we'll take forward. At this point, it's a little early to describe exactly what the expectation is precisely, but rather to say that I think this will be a very informative study based upon its design that will help us optimize the performance of the drug regarding.

[John Paolini, Chief Medical Officer at Kiniksa Pharmaceuticals International]

Competition that's on the horizon. We remain the leaders in the space of recurrent pericarditis for the reason that we have really done the deep work in understanding the mechanism of this disease, and we've identified the fact that IL-1α and IL-1β inhibition is a critical element for maintaining control of the disease and an important fact to be able to maintain control of the disease as monotherapy. We continue to look with interest to see other data as they emerge, but understanding those mechanisms will have to define themselves in the context of the fact that, as I mentioned, we understand that complete control of the disease requires control of both cytokines.

[David Nierengarten, Senior Analyst at Wedbush]

Thank you.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Thanks.

[Operator]

Thank you. This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Sanj Patel for any further remarks.

[Sanj Patel, CEO at Kiniksa Pharmaceuticals International]

Thank you, operator. Thank you, everybody, for the questions and joining the call today. We look forward to the remainder of the year and to providing additional opportunities and updates in the future. Very excited, and thank you very much.

[Operator]

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

Participants

Executives

• Jonathan Kirshenbaum, Investor Relations
• Mark Ragosa, CFO
• John Paolini, Chief Medical Officer
• Sanj Patel, CEO
• Ross Moat, Chief Commercial Officer

Analysts

• David Nierengarten, Senior Analyst at Wedbush
• Eva Fortea-Verdejo, VP and Equity Research Analyst at Wells Fargo Securities
• Geoff Meacham, Managing Director at Citi
• Anupam Rama, Analyst at JP Morgan
• Roger Song, Analyst at Jefferies
• Paul Choi, Executive Director at Goldman Sachs