Kiniksa Pharmaceuticals International, plc (KNSA) Q3 2026 Earnings Call Transcript

Welcome to the Conexa Pharmaceuticals Third Quarter 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'll need to press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Jonathan Cushenbaum, investor relations. Please go ahead, Sarah.

Thank you, Operator. Good morning, everyone, and welcome to the Conixa Pharmaceuticals third quarter 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 for 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 ARCOIST commercial execution. After that, Mark Ragosa, our Chief Financial Officer, will review our third quarter 2026 financial results. And finally, Son will return at the end of the call to share closing remarks and kick off the Q&A session, for which John Paolini, Kinex'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 files. 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'll turn it over to Son.

Thanks, Jonathan, and good morning or good afternoon, everyone. Over the last 10, 11 years, we've built this company through multiple stages of growth. And today, I'm as excited as ever about what the team and I can accomplish together in the years ahead. Connipsa continues to build a leading IO1 Alpha and Vita innovation franchise, driven by the commercialization of ArcList in recurrent pericarditis, as well as our progress with KPL387 and KPL1161. This morning, we announced via a press release that we've raised our full year revenue guidance to between $1.045 and $1.050 billion. We continue to see robust growth with Arculus in recurrent pericarditis, driven by strong execution and strategic investments across the business. On the clinical side, we're excited about the progress of KPL-387 and KPL-1161. The pivotal phase three 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 28-29 timeframe. In addition to providing an important treatment option for patients with recurrent peripoditis, we believe KPL387 could help grow the market by enabling a once monthly sub-Q dosing. We're also on track to have KPL1161, our quarterly IO1-alpha and beta inhibitor in a phase one clinical trial by the end of this year. Importantly, Kinexa's robust financial profile allows us to continue to invest in penetrating the recurrent barricade dieted market and growing the Iowan Alpha and beta inhibition franchise, whilst also pursuing additional value-creating opportunities. In the third quarter, we saw a continuation of strong arcous 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-1 alpha and beta inhibition continues to expand among the approximately 40,000 recurrent pericarditis patients each year. The underlying fundamentals that have propelled our commercial success remain strong. Since launch, we've 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 our costs. Our AI-supported patient identification initiatives and targeted direct-to-consumer campaign, Pass Home, have positively contributed to growing patient and physician awareness of recurrent pericarditis and the important role of IL-1 alpha and beta inhibition in controlling this debilitating disease. As you've heard, we now expect ArcList 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. Kinexa is executing against its strategy to help more patients drive more ArcList growth, KPL 387 and KPL 1161. 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 won't rest until we've helped many, many more patients. And now, our present and COO, Ross Maltz.

Thank you, Sanch. As you've heard, we're pleased with the continued strength of our commercial performance with Arclist, and we're 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 interleukin-1 alpha and beta inhibition. As illustrated on the left side of this slide, physicians continue to report an increasing consideration of ARKLIST earlier in the disease course, including at the first recurrence. Additionally, we also see a growing appreciation for ARKLIST to be utilized earlier in the line of therapy, meaning after NSAIDs and colchizine, 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 three years prior to the publication of this independent guidance. 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, Arculus, and the new treatment paradigm remain critical components of our strategy, and we've enhanced our capabilities through the use of AI and machine learning to reach a larger audience. On the healthcare professional side, we've 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've 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 ARCLIST. As a reminder, Heart's Home is a highly targeted DTC campaign where we've innovated from traditional DTC by using AI to produce and deliver a campaign that's 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 ArcList and empowering them to discuss ArcList with their healthcare provider. As an early indicator of the impact of this campaign, we've seen a 12-fold increase in the traffic to our ArcList website compared to baseline levels prior to the campaign. Additionally, there's been an eight-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 ArcList. All of these indicators are strong signals that our digital strategy is reaching the right audience and is empowering action. 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 Interleukin One Alpha and Beta inhibition franchise is growing, is profitable, and has significant opportunity in the months and years ahead. With that, I'll turn the call over to Mark to review our financial results.

Thanks, Ross. Our third quarter delivered continued arcless sales growth, advancement of KPL 387 and KPL 1161 development in a solid financial position. This morning, I'll review our financial results and key performance drivers. Detailed financial information is available in today's press release. Starting with the income statement, ARCLIS revenue grew 58% year-over-year to $286 million in the third quarter, driven by continued gains in patient and physician adoption. Operating expenses increased year-over-year, driven by higher ARKLIS 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 ARKLIS 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. Turning to the calculation of ARCLIS collaboration profit, which drives total collaboration expenses on our income statement, ARCLIS collaboration profit increased 67% year-over-year to $211.6 million, outpacing sales growth and reflecting disciplined commercial investment. Next, we ended the third quarter 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 ARKLIST sales guidance of $1.045 to $1.050 billion, we are providing full-year R&D and SG&A expense guidance. We expect full-year R&D expenses of $160 to $170 million in 2026. This range includes continued development of KPL 387 and KPL 1161, as well as significant fourth-quarter 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 ARC-List commercialization, including additional personnel and promotional activities in the fourth quarter to further build disease awareness and enhance patient and physician targeting. In closing, our third quarter results show the strength of our operating plan, a growing and profitable arc-less business, funding the advancement of key development assets, and positioning us to create value in the near and long term. With that, I'll turn the call back to Sanj for closing remarks.

Thanks, Mark. As you've heard, Kinexa is jolly well positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. The team and I are on it and focused on helping as many patients as possible with our list and to advance in the development of our clinical portfolio in order to bring additional therapists to patients. With that, I'll send it back to the operator for questions.

Certainly. Thank you. And our first question for today comes from the line of Anuparamo from J.P. Morgan. Your question, please.

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 second half of 2027 is new today. So 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 Thank you John Paulini answer that suffice to say that our execution cost is not just commercial But also because of an organization and as I've said before we are enrolling and dosing patients to 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 and as with ever we go out things with full force and that's what the guidance is as round as they're having results in the second half of next year but John 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 and so the sites that are involved in the program across the world you know are all listed there and so you can see the scope of effort and as Sanj mentioned you know we are on the ground and engaging with with clinicians and we can feel the excitement you know about the program and so we continue forward.

I'll also say we have a crack clinical operations team you know and having run clinical operations for many years of Genzyme before I ran the commercial, I've got a very high bar for clinical research and clinical operations. And, you know, after many, many years, I feel like we've really got the best team to do Thanks so much for taking our question, and congrats for getting down the corridor.

Thank you. And our next question comes from the line of Edward Nash from Canaccord Genuity. Your question, please.

Hey, good morning, guys. I'm really, really excited to see that over $1 billion number now for the guidance, so congratulations. I just want to ask now, you're at 23% active penetration. That's 2% higher the last quarter, which is really, I think, impressive. Can maybe you 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 know, you're going up on the SG&A number, which makes a lot of sense, and you've put a lot of focus in the DTC campaign, which clearly seems to be paying off. Just kind of curious as to how many extra dollars need to be put in to kind of achieve greater uptake of Scripps.

Thanks, Edward. This is Ross. So thanks very much for your comments. And, yeah, we're pleased to announce that, you know, we're 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 two or more recurrences. and that's without allocating anything to the first recurrence group, which we've got about 20% of our prescriptions in the first recurrence group also. So the opportunity is very significant. While on one hand, we're happy with the 23% and that's obviously showing a couple of percent growth versus the end of Q2 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% of the end of last year. So that's been growing relatively nicely, but I think more importantly is the opportunity that's ahead. I mean, clearly there are a lot of patients in the 2-plus recurrence group that we've still got to help, and as I said, not allocating for even those who are in the first recurrence. And as we shared from some of the market research today, the propensity and the desire for physicians to look and treat patients with IL-1 alpha-beta 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 kind of different patient groups, aside from the recurrence number, there's really not much else to report. We're not seeing significant change necessarily in the demographics of the patients or severity levels or anything else. It's just that this is a rare flare in cardiovascular disease. There are a lot of patients out there relative to a rare disease. and we're 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 and ultimately get greater penetration into this opportunity to ultimately help more patients.

Thanks a lot for that. I'm sorry, go ahead.

Yeah, no, Edward, maybe just to add the final part as well, is that the DTC spend and field team spend that we have and we've announced in our guidance looking forward as well is ultimately very efficient. You know, we are very focused on this as a rare disease market, and for the DTC side of things, this is not kind of broad spectrum, massive spend DTC. It's very efficient, very targeted type of expenditure to address appropriately the market that we have.

Great. Thanks for that additional color and really great quarter. Thanks again. Congratulations.

Thank you. And our next question comes from the line to Paul Choi from Goldman Sachs. Your question, please.

Hi, everyone. Congratulations on the great quarter, and congrats, Ross, as well, on the new title. I want to ask on the 387 switch strategy, and I was wondering if you could just sort of provide a little more color on where you are with progress on that, and I guess what the ultimate data you are looking for there to support 387 from an insurance perspective. And my second question is on 1161, maybe, you know, just, you know, where are you thinking in terms of indication selection, I guess, at this point, and a little bit more on the criteria that you're considering for the next, for the first indication there for 1161? Thank you so much. Thank you, Paul. I appreciate your questions. This is John. So with regard to the KPL387 transition to monotherapy dosing and administration study, I mean, this study is designed primarily as what we call a posology study. So it covers dosing administration specifically for informing the label. So it's designed, as you can see in the slides, for looking at how patients are coming from stable therapies, whether they're oral or biologic, and then transitioning to KPL-387 monotherapy at the 300 milligram subcutaneous monthly dose level. And so that's really what that study is designed to do. It follows very similarly the precedent of what's in the Arculus label, which similarly describes the transitions from NSAIDs, colchicine, corticosteroids, and Akinra. So this is just really following in that tradition. So that's how the study is designed and the data that will be generated. But I'll turn it over to Ross to talk about ultimately other elements of transition.

Yeah, thanks very much, John. I mean, I guess, you know, just to say that obviously we're very excited about the potential for KPL387, but, you know, everything's kind of data dependent as we move forward. But when we tested the target product profile for KPL387, both with healthcare professionals and patients, we were really very encouraged by the feedback that we had back. And while we believe that ArcList has a lot of growth left in it to address the recurrent pericarditis opportunity, with KPL387, patients did tell us that around 75% of them would prefer the KPL387 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. And then when you looked at the healthcare professional side, 92% of healthcare professionals indicated a high likelihood to prescribe KPL387 with that target product profile over available commercial or other investigational therapies. So, you know, that I think reads quite positively about the future, but ultimately we are focused on conducting the clinical research and awaiting the data.

And then with regard to your question about 1161, so we're very excited about this program, which has the potential for once quarterly dosing, again, targeting the IL-1 alpha and beta signaling by targeting the receptor. And so this program, we expect to begin a Phase I program by the end of the year. And 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?

No, that's great, Joe. That's great.

Thank you. And our next question comes from the line of Roger's talk from Jefferies. Your question, please.

This is Peter. I'm calling up for Roger. Congrats on a good quarter, and thanks for taking our questions. Just a couple of quick ones from us. For third quarter, can you tell us what share of the new patients came from first-time versus repeat prescribers? And can you also share whether or how much growth you've seen within the first recurrence patients as well for this quarter?

Yeah, Peter, thanks very much for the questions. We don't share some of that data directly, externally, but, of course, it's the type thing that we look at a lot internally um in the business what we have shared is this in the q3 um clearly we've seen a substantial uplift in in the number of patients uh representing the strong growth of 42 need 42 and a half million dollars uh a quarter on quarter and ultimately that's driven by strong prescriber growth um what we have said is that when you look at the total number of prescribers launched a date of ArcList for recurrent pericarditis. In Q3, I should say at the end of Q3, we had around 5,450 total prescribers. Now, that's an uplift of around 450 quarter on quarter. So again, it's really showing very strong growth. And now we have around 30% of that group who are repeat prescribers, which is up by around 170 prescribers. Historically, we've 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 haven't updated that data on a very frequent basis as a lot of it comes from kind of ad hoc market research that we do. But clearly, we're showing pretty strong growth in Q3. And 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 and also just broader dissemination of the ACC concise clinical guidance and and really just empowering physicians on this new way of treating the disease thanks so much for the additional color and congrats again on the quarter thanks Peter thank you and our next question comes from the line of Jeff Meacham from Citi your question please Hey, guys, great job on the quarter.

Thanks for the question. Just have a couple of quick ones. The first on 387, I know convenience angle, obviously, is a big differentiator, but beyond that, you know, is there a patient maybe on our class today that you think is particularly suited to transition to 387? Just beyond convenience, I know clinically, maybe those that live further away, or what are the attributes of the patient's, I guess, is the question that would maybe more rapidly switch. And then bigger picture question just on the, you know, cash and the capital deployment. You guys have been consistently, you know, profitable, you're building some cash on the balance sheet. I don't know, just trying to think of ways to maximize value from, you know, from a balance sheet cash flow context. Like, what, you know, what are you thinking about from a BD perspective? Where does this fall in your priorities?

Thank you, Jeff, for your question. I'll tackle this first part with regard to the transition, if you will, from ARC-List to KPL-387. I mean, I think that our position with regard to the management of the disease is that blockade of IL-1-alpha and IL-1-beta is critical to maintaining disease control and to gaining the disease control as a monotherapy. And so in that sense, we're particularly excited about the KPL387 program because it adds to the optionality of what's available to patients and physicians in terms of treating this disease. And so, you know, that efficacy ultimately, you know, remains to be demonstrated in the Phase III pivotal trial, which is ongoing. But importantly, what we have going on as well is the 2-1-2 study or the KPL-387 transition to monotherapy dosing and administration study, which is really designed to look at how the mechanics of how to transition from one existing therapy to KPL-387 monotherapy at the 300 milligram monthly dose level. And so that includes NSAIDs and colchicine, corticosteroids, or IL-1 pathway inhibitors, including Anakinra and Rolanosept. And all of those different transition regimens are studied and, you know, are evaluated in the study, and then go on to over a 16-week, you know, primary endpoint period. So it's really about that transition. And that then informs the label with regard to telling or informing physicians how they can make that transition. But in terms of the patient profile, it's really about the optionality for the patient and the physician to choose which therapy, which effective therapy, you know, is considered to be best for them.

And, Jeff, in regards to your question on maximizing the value and cat physician, I mean, I can tell you what drives us each and every day is the potential to increase that overall maximum value. There's so much kinetic energy within the company that's focused on that. We've talked about, obviously, today, the growth with Arculus, and we continue to be very excited about the future potential there we talked about the latest penetration rate being in some ways only 23 but equally obviously across the development portfolio with kpl387 and 1161 as we've talked about really moving now into the obviously the phase three pivotal study for 387 being very excited about being in the clinic with 1161 later this year but as you've seen those last two programs were homegrown so we continue to look at other additional value creating opportunities both internally and but also externally i think we've 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're very pragmatic bud so we do look at where the value could come from all the time it's what drives us essentially. So rest assured, we know how to capital allocate. We know it best to drive value and we'll continue doing that and ultimately keep executing.

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

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 patience and for creating that additional value thank you thank you ladies for your participation in today's conference this does conclude the program you may now disconnect good day