Operator: Thanks for standing by, and welcome to the Kiniksa Pharmaceuticals Q3 2026 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 will need to press star one one on your telephone. If your question has been answered and you would like to remove yourself from the queue, simply press star 11 again. As a reminder, today's program is being recorded. Now I would like to introduce your host for today's program, Jonathan Kirshenbaum, Investor Relations. Please go ahead, sir.
Jonathan Kirshenbaum: Thank you, operator. Good morning, everyone, and welcome to the Kiniksa Pharmaceuticals Q3 2026 earnings call. A press release highlighting our financial results and recent portfolio execution can be found on our website under the investors section. As to the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. From there, Ross Moat, our Chief Operating Officer, will provide an update on ARCALYST commercial execution. After that, Mark Ragosa, our Chief Financial Officer, will review our Q3 2026 financial results.
Jonathan Kirshenbaum: Finally, Sanj will return at the end of the call to share closing remarks and kick off the Q&A session, for which John Paolini, Kiniksa's 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 such statements. A review of these statements and risk factors can be found on this slide, as well as under the caption Risk Factors contained in our SEC filings.
Jonathan Kirshenbaum: 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 K. Patel: Thanks, Jonathan, and good morning or good afternoon, everyone. Over the last 10, 11 years, we have built this company through multiple stages of growth, and today I am as excited as ever about what the team and I can accomplish together in the years ahead. Kiniksa continues to build a leading IL-1α and IL-1β inhibition franchise driven by the commercialization of ARCALYST in recurrent pericarditis, as well as our progress with KPL-387 and KPL-1161. This morning, we announced via a press release that we have raised our full year revenue guidance to between $1.045 billion and $1.050 billion.
Sanj K. Patel: We continue to see robust growth with ARCALYST in recurrent pericarditis, driven by strong execution and strategic investments across the business. On the clinical side, we are excited about the progress of KPL-387 and KPL-1161. The pivotal Phase III study with KPL-387 continues to enroll and dose patients. We announced today that we expect data from this trial in the second half of 2027. The team and I are really looking forward to potentially launching this drug in the 2028, 2029 timeframe.
Sanj K. Patel: In addition to providing an important treatment option for patients with recurrent pericarditis, we believe KPL-387 could help grow the market by enabling a once-monthly subcutaneous dosing. We are also on track to have KPL-1161, our quarterly IL-1α and IL-1β inhibitor, in a phase I clinical trial by the end of this year. Importantly, Kiniksa's robust financial profile allows us to continue to invest in penetrating the recurrent pericarditis market and growing the IL-1α and IL-1β inhibition franchise, whilst also pursuing additional value-creating opportunities.
Sanj K. Patel: In the third quarter, we saw a continuation of strong ARCALYST momentum, with Q3 revenue of $286 million. The penetration rate into the annual population of 14,000 multiple recurrence patients increased to 23% as of the end of Q3. As shown by the increased breadth and depth of prescribing over time, adoption of IL-1α and IL-1β inhibition continues to expand among the approximately 40,000 recurrent pericarditis patients each year. The underlying fundamentals that propelled our commercial success remain strong.
Sanj K. Patel: Since launch, we have observed robust payer approval, strong patient compliance, and greater appreciation of the need to treat throughout the multi-year duration of the disease. Underpinning this growth is strong execution by our commercial organization and data-driven investments in ARCALYST. Our AI-supported patient identification initiatives and targeted direct-to-consumer campaign, Heart's Home, have positively contributed to growing patient and physician awareness of recurrent pericarditis, and the important role of IL-1α and IL-1β inhibition in controlling this debilitating disease.
Sanj K. Patel: As you have heard, we now expect ARCALYST to achieve over $1 billion in revenue in 2026, and we look forward to continuing to bring this blockbuster drug to more patients suffering from this debilitating disease. In order to grow the recurrent pericarditis market over the next several years, we plan to drive greater adoption in both the 14,000 multiple recurrence patients annually and the additional 26,000 patients annually that are experiencing their first recurrence. Kiniksa is executing against its strategy to help more patients drive more ARCALYST growth and advance KPL-387 and KPL-1161.
Sanj K. Patel: This trajectory will help put the company on a path to having multiple commercial products, continued strong and profitable growth, and the flexibility to invest in future value creation. I can tell you that the team and I will not rest until we have helped many, many more patients. Now, our President and COO, Ross Moat.
Ross Moat: Thank you, Sanj. As you have heard, we are pleased with the continued strength of our commercial performance with ARCALYST, and we are even more excited by the substantial growth opportunity ahead. We continue to be highly focused on further increasing the penetration rate into the many thousands of recurrent pericarditis patients and continuing to evolve the treatment paradigm towards IL-1α and IL-1β inhibition. As illustrated on the left side of this slide, physicians continue to report an increasing consideration of ARCALYST earlier in the disease course, including at the first recurrence.
Ross Moat: Additionally, we also see a growing appreciation for ARCALYST to be utilized earlier in the line of therapy, meaning after NSAIDs and colchicine, and importantly, prior to corticosteroids, as ratified in the 2025 American College of Cardiology Concise Clinical Guidance for Recurrent Pericarditis. In fact, approximately 50% of physicians surveyed now support this treatment approach, representing a doubling from levels over the last 3 years prior to the publication of this independent guidance.
Ross Moat: As we continue to build and lead this market, our team are laser-focused on value-driven investments that aim to increase market penetration and help many more patients. Increasing education and awareness on recurrent pericarditis, ARCALYST, and the new treatment paradigm remain critical components of our strategy, and we have enhanced our capabilities through the use of AI and machine learning to reach a larger audience.
Ross Moat: On the healthcare professional side, we have done this through improving our data sources to inform us not only which healthcare professionals we should be seeing, but importantly, when we should be seeing them. On the patient side, we have seen encouraging early indicators from our Heart's Home direct-to-consumer campaign. Based on this initial traction, we plan to expand the campaign with additional content and outreach initiatives aimed at empowering more patients to engage with their healthcare professionals about ARCALYST.
Ross Moat: As a reminder, Heart's Home is a highly targeted DTC campaign where we have innovated from traditional DTC by using AI to produce and deliver a campaign that is effective for a rare disease audience. This campaign is aimed at educating an enriched population of likely recurrent pericarditis patients who are currently not taking ARCALYST, and empowering them to discuss ARCALYST with their healthcare provider. As an early indicator of the impact of this campaign, we have seen a 12-fold increase in the traffic to our ARCALYST website compared to baseline levels prior to the campaign.
Ross Moat: Additionally, there has been an 8-fold increase with engaged sessions, meaning visits where the individual spends meaningful time on the website or interacts with the content. More importantly, approximately 55% of patients who saw the ad strongly agreed that they are motivated to speak with their healthcare provider about ARCALYST. All of these indicators are strong signals that our digital strategy is reaching the right audience and is empowering action.
Ross Moat: As this disease has a very high annual incident rate of patients coming into the labeled indication, this DTC initiative is nicely supplementing our robust execution in the field and helps us to address the substantial opportunity that we have ahead to help many more patients. As previously mentioned, our IL-1α and IL-1β inhibition franchise is growing, is profitable, and has significant opportunity in the months and years ahead. With that, I will turn the call over to Mark to review our financial results.
Mark Ragosa: Thanks, Ross. Our Q3 delivered continued ARCALYST sales growth, advancement of KPL-387 and KPL-1161 development, and a solid financial position. This morning, I will review our financial results and key performance drivers. Detailed financial information is available in today's press release. Starting with the income statement, ARCALYST revenue grew 58% year-over-year to $286.0 million in the Q3, driven by continued gains in patient and physician adoption.
Mark Ragosa: Operating expenses increased year-over-year, driven by higher ARCALYST revenue, which resulted in additional cost of goods sold and collaboration expenses, advancement of KPL-387 development, which drove additional R&D investment, and support of ARCALYST commercialization to reach more patients, which led to additional SG&A investment. Operating income rose to $54.2 million and net income to $47.3 million, both up significantly year-over-year.
Mark Ragosa: Turning to the calculation of ARCALYST collaboration profit, which drives total collaboration expenses on our income statement, ARCALYST collaboration profit increased 67% year-over-year to $211.6 million, outpacing sales growth and reflecting disciplined commercial investment. Next, we ended the Q3 with $568.8 million in cash, reflecting approximately $43 million in net cash generation during the quarter. Looking ahead, in addition to our updated 2026 ARCALYST sales guidance of $1.045 billion to $1.050 billion, we are providing full year R&D and SG&A expense guidance.
Mark Ragosa: We expect full year R&D expenses of $160 million to $170 million in 2026. This range includes continued development of KPL-387 and KPL-1161, as well as significant Q4 KPL-387 pre-commercial manufacturing costs. We expect full year SG&A expenses of $270 million to $280 million in 2026. This range supports continued ARCALYST commercialization, including additional personnel and promotional activities in the Q4 to further build disease awareness and enhance patient and physician targeting.
Mark Ragosa: In closing, our Q3 results show the strength of our operating plan, a growing and profitable ARCALYST business, funding the advancement of key development assets and positioning us to create value in the near and long term. With that, I will turn the call back to Sanj for closing remarks.
Sanj K. Patel: Thanks, Mark. As you have heard, Kiniksa is jolly well positioned to build significant future value as we grow our IL-1α and IL-1β inhibition franchise. The team and I are on it and focused on helping as many patients as possible with ARCALYST and to advancing the development of our clinical portfolio in order to bring additional therapies to patients. With that, I will turn it back to the operator for questions. Thank you.
Operator: Certainly. Thank you. Our first question for today comes from the line of Anupam Rama from JPMorgan. Your question, please.
Anupam Rama: Hey, guys. Thanks so much for taking the question, and congrats on the quarter. I just wanted to ask a quick KPL-387 question. I think the guidance for pivotal data in the H2 2027 is new today. Can you tell us what you're seeing in terms of enrollment dynamics and where you are on site initiation that give you confidence to laying out this timeline? Thanks so much.
Sanj K. Patel: Thanks, Anupam. I think I'll have John Paolini answer that. Suffice to say that our execution crosses not just commercial but also the clinical development organization. As I've said before, we are enrolling and dosing patients. It's a global clinical study with global sites, and both myself, John, and Ross take pride in meeting with investigators and just getting them excited about the future. So there's been some massive momentum, both internally and with our investigators. As with everything, we go at things with full force. That's why the guidance is as well and is having results in the H2 of next year. But, John?
John Paolini: Yeah, I think that's excellent guidance from Sanj. The only thing that I would add is that on ClinicalTrials.gov, you can see the extent of the global nature of our program. So the sites that are involved in the program across the world are all listed there. You can see the scope of effort. As Sanj mentioned, we are on the ground and engaging with clinicians, and we can feel the excitement about the program, and so we continue forward.
Sanj K. Patel: I'll also say we have a crack clinical operations team. Having run clinical operations for many years at Genzyme before I ran commercial, I've got a very high bar for clinical research and clinical operations. After many, many years, I feel like we've really got the best team to do the job.
Anupam Rama: Thanks so much for taking our question, and congrats again on the quarter.
Operator: Thank you. Our next question comes from the line of Edward Nash from Canaccord Genuity. Your question, please.
Edward Nash: Hey, good morning, guys. Really excited to see that over $1 billion number now for the guidance. So congratulations. I just wanted to ask now, you're at 23% active penetration. That's 2% higher than last quarter, which is really, I think impressive. Can you maybe give us an idea of how we should think about the shape of the penetration curve from here? Is there anything structurally different about the next quartile of patients versus the patients you've already converted? You're going up on the SG&A number, which makes a lot of sense.
Edward Nash: You've put a lot of focus on the DTC campaign, which clearly seems to be paying off. Just curious as to how many extra dollars need to be put in to achieve greater uptake of scripts.
Ross Moat: Thanks, Edward. This is Ross. Thanks very much for your comments. We are pleased to announce that we were around 23% at the end of the quarter in terms of penetration into the multiple recurrence group, which is the patients that have suffered for 2 or more recurrences. That is without allocating anything to the first recurrence group, which we have about 20% of our prescriptions in the first recurrence group also.
Ross Moat: The opportunity is very significant. While on one hand, we are happy with the 23%, and that is obviously showing a couple of percent growth versus the end of Q3 number when we shared it. The time before that, the last time we shared the penetration number, I think it was at the end of Q4, which was 18% at the end of last year. That has been growing relatively nicely. But I think more importantly is the opportunity that is ahead. Clearly there are a lot of patients in the 2-plus recurrence group that we have still got to help, and as I said, not allocating to even those who are in the first recurrence.
Ross Moat: As we shared from some of the market research today, the propensity and the desire for physicians to look and treat patients with IL-1α and IL-1β inhibition in the first group has also been growing quite substantially over time. So we think the future is very bright from that perspective. In terms of different patient groups, aside from the recurrence number, there is really not much else to report. We are not seeing significant change necessarily in the demographics of the patients or severity levels or anything else. It is just that this is a rare flaring cardiovascular disease.
Ross Moat: There are a lot of patients out there relative to a rare disease. We are trying to get out and reach as many patients as possible. We know that they are widely dispersed around the country, and that takes a certain effort, as you have alluded to, from our sales and marketing spend and so on. But our efforts are ultimately on value-driven investments that can make sure we reach those physicians and switch more and more of them on to this new way of treating. Ultimately get greater penetration into this opportunity to ultimately help more patients.
Edward Nash: Thanks a lot for that additional coloring. I am sorry, go ahead.
Ross Moat: Yeah. Edward, maybe just to add the final part as well is that the DTC spend and field team spend that we have and we have announced in our guidance looking forward as well is ultimately very efficient. We are very focused on this as a rare disease market. For the DTC side of things, this is not broad-spectrum, massive spend DTC. It is very efficient, very targeted type of expenditure to address appropriately the market that we have.
Edward Nash: Great. Thanks for the additional color and really great quarter. Thanks again, and congratulations.
Operator: Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question, please.
Paul Choi: Hi, everyone. Congratulations on the great quarter and congrats, Ross, as well on the new title. I want to ask on the KPL-387 switch strategy. I was wondering if you could just provide a little more color on where you are with progress on that. I guess what the ultimate data you are looking for there to support KPL-387 from an insurance perspective. My second question is on KPL-1161. Maybe just where are you thinking in terms of indication selection, I guess, at this point, and a little bit more on the criteria that you are considering for the first indication there for KPL-1161. Thank you so much.
John Paolini: Thank you, Paul. Appreciate your questions. This is John. With regard to the KPL-387 transition to monotherapy dosing and administration study, this study is designed primarily as what we call a posology study. It covers dosing administration specifically for informing the label. It is designed, as you can see in the slides, for looking at how patients are coming from stable therapies, whether they are oral or biologic, and then transitioning to KPL-387 monotherapy at the 300 milligram subcutaneous monthly dose level. That is really what that study is designed to do.
John Paolini: It follows very similarly the precedent of what is in the ARCALYST label, which similarly describes the transitions from NSAIDs, colchicine, corticosteroids, and anakinra. This is just really following in that tradition. That is how the study is designed and the data that will be generated. I will turn it over to Ross to talk about ultimately other elements of transition.
Ross Moat: Yeah. Thanks very much, John. I guess just to say that obviously we are very excited about the potential for KPL-387, but everything is data dependent as we move forward. When we tested the target product profile for KPL-387, both with healthcare professionals and patients, we were really very encouraged by the feedback that we had back.
Ross Moat: While we believe that ARCALYST has a lot of growth left in it to address the recurrent pericarditis opportunity, with KPL-387, patients did tell us that around 75% of them would prefer the KPL-387 target profile being a monthly liquid formulation, potentially auto-injector over current commercial or other investigational therapies. They also reported a propensity for a greater number of patients to start on therapy with that target product profile, as well as staying on therapy longer.
Ross Moat: When you looked at the healthcare professional side, 92% of healthcare professionals indicated a high likelihood to prescribe KPL-387 with that target product profile over available commercial or other investigational therapies. That I think reads quite positively about the future, but ultimately, we are focused on conducting the clinical research and awaiting the data.
John Paolini: With regard to your question about 1161. We are very excited about this program, which has the potential for once quarterly dosing, again, targeting the IL-1α and IL-1β signaling by targeting the receptor. This program, we expect to begin a phase I program by the end of the year. To that extent, we have not yet announced or disclosed our plans with regard to development indications. Suffice it to say, though, that with that longer duration of action, that really unlocks a lot of potential for disease states, especially those that are chronic or lifelong in nature by virtue of the once quarterly dosing. Ross, anything to add?
Ross Moat: No, that is great, John. Thank you.
John Paolini: That is great.
Operator: Thank you. Our next question comes from the line of Roger Song from Jefferies. Your question please.
[Analyst] (Jefferies): Morning, this is Peter. I am calling in for Roger. Congrats on the good quarter, and thanks for taking our questions. Just a couple quick ones from us. For Q3, can you tell us what share of the new patients came from first time versus repeat prescribers? Can you also share whether or how much growth you have seen within the first recurrence patients as well for this quarter?
Ross Moat: Yeah, Peter, thanks very much for the questions. We do not share some of that data directly externally, but of course it is the type of thing that we look at a lot internally in the business. What we have shared is in Q3, clearly we have seen a substantial uplift in the number of patients representing the strong growth of nearly $42.5 million quarter-on-quarter. Ultimately, that is driven by strong prescriber growth. What we have said is that when you look at the total number of prescribers launched to date of ARCALYST for recurrent pericarditis in Q3, or I should say the end of Q3, we had around 5,450 total prescribers.
Ross Moat: That is an uplift of around 450 quarter-on-quarter. Again, it is really showing very strong growth. Now we have around 30% of that group who are repeat prescribers, which is up by around 170 prescribers. Historically, we have said that the split between the first and second recurrence is about 80% of prescriptions in the second plus recurrence and 20% in the first, but we have not updated that data on a very frequent basis as a lot of it comes from ad hoc market research that we do. Clearly we are showing pretty strong growth in Q3.
Ross Moat: A lot of that is down to the refined targeting that we have with our field team, the DTC campaign in a very targeted approach. Also just broader dissemination of the ACC concise clinical guidance and really just empowering physicians on this new way of treating the disease.
[Analyst] (Jefferies): Got it. Thanks so much for the additional color, and congrats again on the quarter.
John Paolini: Thanks, Peter.
Operator: Thank you. Our next question comes from the line of Geoff Meacham from Citi. Your question please.
Geoff Meacham: Hey, guys. Great job on the quarter. Thanks for the question. I have a couple of quick ones. The first on KPL-387, I know convenience angle obviously is a big differentiator. Beyond that, is there a patient maybe on ARCALYST today that you think is particularly suited to transition to KPL-387 just beyond convenience? I know clinically, maybe those that live further away, or what are the attributes of the patients, I guess is the question that would maybe more rapidly switch. Then bigger picture question, just on the cash and the capital deployment.
Geoff Meacham: You guys have been consistently profitable. You are building some cash on the balance sheet. I do not know, just trying to think of ways to maximize value from a balance sheet cash flow context. What are you thinking about from a BD perspective? Where does this fall in your priorities? Thank you.
John Paolini: Thank you, Geoff, for your question. I will tackle this first part with regard to the transition, if you will, from ARCALYST to KPL-387. I think that our position with regard to the management of the disease is that blockade of IL-1α and IL-1β is critical to maintaining disease control and to gaining the disease control as a monotherapy. In that sense, we are particularly excited about the KPL-387 program because it adds to the optionality of what is available to patients and physicians in terms of treating this disease. That efficacy ultimately remains to be demonstrated in the phase III pivotal trial, which is ongoing.
John Paolini: Importantly, what we have going on as well is the 212 study or the KPL-387 transition to monotherapy dosing and administration study. Which is really designed to look at the mechanics of how to transition from one existing therapy to KPL-387 monotherapy at the 300 milligram monthly dose level. That includes NSAIDs, colchicine, corticosteroids, or IL-1 pathway inhibitors, including anakinra and rilonacept. All of those different transition regimens are studied and are evaluated in the study and then go on to over a 16-week primary endpoint period. It is really about that transition.
John Paolini: That then informs the label with regard to telling or informing physicians how they can make that transition. In terms of the patient profile, it is really about the optionality for the patient and the physician to choose which effective therapy is considered to be best for them.
Sanj K. Patel: Jeff, in regards to your question on maximizing value and cash position, I can tell you what drives us each and every day is the potential to increase that overall maximum value. There is so much kinetic energy within the company that is focused on that. We have talked about, obviously today, the growth with ARCALYST, so we continue to be very excited about the future potential there. We talked about the latest penetration rate at being, in some ways, only 23%.
Sanj K. Patel: Equally, obviously, across the development portfolio with KPL-387 and KPL-1161, as we have talked about, really moving now into the, obviously the phase III pivotal study for KPL-387, being very excited about being in the clinic with KPL-1161 later this year. As you see, those latter two programs were homegrown, so we continue to look at other additional value creating opportunities, both internally but also externally.
Sanj K. Patel: I think we have been very judicious and very thoughtful about capital allocation. We do look at BD opportunities, but as you can imagine, with our commercial products, with our pipeline, the bar is exceedingly high. That said, we are a very pragmatic bunch, and we do look at where the value could come from all the time. It is what drives us, essentially. So rest assured, we know how to capital allocate. We know it best to drive value, and we will continue doing that and ultimately keep executing.
Geoff Meacham: Great. Thank you.
Operator: Thank you. This does conclude the question and answer session of today's program. I would like to hand the program back to Sanj K. Patel, CEO, for any further remarks.
Sanj K. Patel: Thank you very much. Thanks everybody for dialing in today. Clearly a lot of excitement, ongoing execution, and very excited about the future. The team and I will keep driving for future success for patients and for creating that additional value. Thank you.
Operator: Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.
