Kiniksa Pharmaceuticals International Q2 2025 Earnings Call Transcript

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Provided by Quartr
July 29, 2025

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%.
AI Generated. May Contain Errors.
Earnings Conference Call
Kiniksa Pharmaceuticals International Q2 2025
00:00 / 00:00

There are 11 speakers on the call.

Operator

Thank you for standing by and welcome to the Connexa Pharmaceuticals Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Jonathan Kirschenbaum, Investor Relations.

Operator

Please go ahead, sir.

Speaker 1

Thank you, operator. Good morning, everyone, and thank you for joining Conixa's call to discuss our second quarter twenty twenty five 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.

Speaker 1

Ross Mote, Conixa's Chief Commercial Officer, will provide an update on Arcelis' commercial execution. Then Mark Ragosa, our Chief Financial Officer, will review our second quarter twenty twenty five financial results. Finally, Sanj will share closing remarks and kick off the Q and A session, for which John F. Paulini, our Chief Medical Officer and Evan Tesori, our Chief Operating Officer, will also be on the line. Before getting started, please note that we will be making forward looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements.

Speaker 1

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 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 Saj.

Speaker 2

Thanks Jonathan, and good morning everyone. I'm happy to review KINXA's second quarter financial results and the highlights across our portfolio. Kynixa continues to build upon the strength across our business, which is driven by both our commercial execution with ArcLIST and our pipeline development programs, including KPL-three 87. Arclis 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 $156,800,000 in the second quarter.

Speaker 2

This represents a growth of $19,000,000 over the first quarter. In just over four years, since the launch of ArcLIST, as the first and only FDA approved therapy for recurrent pericarditis, Kenyxxa has generated over $1,000,000,000 in cumulative net sales. 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. Kynixa is well positioned to continue maximizing the potential of Arcalis. For full year 2025, we're raising our Arcalis net sales guidance to between $6.25 and $640,000,000 from $5.90 to $6.00 $5,000,000.

Speaker 2

Importantly, growing Arclus 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 twophase three clinical trial of KPL-three eighty seven in recurrent pericarditis. This next slide highlights the design of the phase two, three clinical trial. In designing this study, we've leveraged our experience with Rhapsody, which was the successful phase three pivotal trial supporting FDA approval of Arclis in recurrent pericarditis. This study consists of three overlapping parts, which have been combined into a single protocol.

Speaker 2

The phase two dose focusing portion, the phase three 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 twenty eight-twenty nine timeframe. Thanks to the excellent work of our teams, Kynixa is the leader in recurrent pericarditis. Importantly, we are committed to driving additional innovation for these patients, and maintaining our leadership position.

Speaker 2

Our physician and patient market research shows an IL-one alpha and beta inhibitor with the target profile of KPL-three eighty seven 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 auto injector 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

Speaker 3

over to Ross. Thank you, Saj. Strong execution in Q2 led to significant revenue growth to $156,800,000 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.

Speaker 3

We are seeing this patient cohort follow similar metrics to other groups of patients on ARC List. 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. As a result of the increase in active patients, our penetration into the multiple recurrence population increased from approximately thirteen percent at the end of last year to approximately fifteen percent at the end of Q2. Ultimately, this growth reflects the patients and healthcare professionals continue to report high degrees of satisfaction with Arcelis and we've built a robust foundation of commercial fundamentals. For example, in Q2, our payer approval rates remained greater than ninety percent.

Speaker 3

Total duration of therapy was approximately thirty months on average. Patient compliance with therapy remained strong over eighty five percent, and we continue to see Arcelis 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 Arcelis. On this slide, I'm going to highlight how ArcLIS 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-one alpha and beta mediated disease best managed with targeted immunomodulation.

Speaker 3

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 three twenty five additional health care professionals wrote their first Arclis prescription, representing one of the highest quarter on quarter increases to date and bringing the total number of prescribers to more than 3,475. Additionally, repeat prescribing also continued to increase with more than 120 Arclis prescribers writing for their second patients. Finally, we've also seen an increase in prescribing earlier in the disease.

Speaker 3

Of all the patients on ARC List, around twenty percent were prescribed ARC List while on their first recurrence, and roughly eighty percent when they had two or more recurrences. This highlights the growing physician appreciation for the value Arclis provides in preventing their patients from suffering future flares. In addition to more patients receiving ArcLIS 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 for healthcare providers well versed in their disease. We have sponsored the Addressing Recurrent Pericarditis Initiative as part of our ongoing efforts to shorten the treatment journey for patients by providing expert care close to home. 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.

Speaker 3

As the treatment approach continues to change across the country, there's a growing body of published literature recommending IL-one pathway inhibitors such as Arclis to be used ahead of corticosteroids, which is well aligned with our commercial positioning of Arclis. Furthermore, looking at data from RESONENCE, our real world evidence disease registry, which is driven by expert pericardial centers across the country, Arclinus has increasingly become the second line treatment choice after NSAIDs and colchicine. In Q2, we delivered $156,800,000 in net revenue as well as increased the franchise profitability. As a result, we are pleased to increase our 2025 net revenue guidance by $35,000,000 between the midpoints of the prior range and of the new range. This takes us from expecting between $590,000,000 to $6.00 $5,000,000 to now expecting between $625,000,000 and $640,000,000 This guidance indicates year on year net revenue growth of $215,000,000 at the midpoint compared to full year 2024.

Speaker 3

This would be the highest annual increase in net revenue to date. As you can hear, we're excited about the future of Arcelis 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. And with that, I'll turn the call over to Mark to discuss our financial results. Mark?

Speaker 4

Thanks, Ross. This morning, I will cover our second quarter twenty twenty five 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.

Speaker 4

ArcList revenue grew 52% year over year in the second quarter to $156,800,000 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 ARC List revenue growth and SG and A in support of ARC List commercialization. Lastly, due to strong revenue growth coupled with more moderate expense growth, net income was $17,800,000 in the second quarter compared to a net loss of $3,900,000 a year ago. Second, the right hand side of the slide provides the calculation of ArcLis collaboration profit, which grew 75% year over year in the second quarter to 104,800,000.0 driven by sales volume and disciplined commercial investment. Third, at the bottom of the slide, our cash balance increased by approximately $40,000,000 to $307,800,000 in the second quarter and we continue to expect our current operating plan to remain cash flow positive on an annual basis.

Speaker 4

As you've heard from Sanj and Ross, both commercial and clinical execution in the second quarter added to Kinetics' significant momentum across its business. Combined with financial discipline and a strong balance sheet, KINXA remains well positioned to continue to help patients as well as to create additional value in both the near and long term. And with that, I'll turn the call back to Saans for closing remarks.

Speaker 2

Thanks Mark. As you've heard, Fenixa 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 Arclisp, and to advancing the development of our clinical portfolio, which includes KPL-three eighty seven, the liquid formulation IL-one receptor antagonist, which 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.

Speaker 2

Thank you.

Operator

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

Speaker 5

Hey guys. Thanks so much for taking the question and congrats on the quarter. I know you highlighted 15% penetration into the 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.

Speaker 5

Thanks so much.

Speaker 3

Yeah, thanks very much, Anupam. This is Ross. Thank you for the question. So you're right that in the two plus recurrence group, as a reminder, that's the fourteen thousand patient population in any given year. We've seen continuous increase since the launch into the penetration into that group, most recently going to fifteen percent versus last reported at the 2024 of thirteen percent.

Speaker 3

So seeing some nice increase within that group and that remains our key target base as the patient groups who are suffering the most, had the highest burden of the disease, also most closely aligned with the data in RABPD as well. But we've also seen as the treatment paradigm has changed over time, significant growth in earlier on in the disease. So those patients are still very much within label, the broad label that we have just for recurrent pericarditis agnostic to the number of flares. And there's an additional group of twenty six thousand patients in that first recurrence group, which is a significant opportunity for us. And I think what we're seeing now with around twenty percent of all the ARKLIST patients that were prescribed to 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 ARC List, and just greater comfort overall for healthcare professionals having greater experience with drug and having seen the impact that it has on patients in the real world setting to utilize this drug early on in the disease.

Speaker 3

I think as well as an increase in understanding that recurrent pericarditis is a disease which is mediated by interleukin-one alpha and beta. And in order to control that disease and prevent future flares, patients having to needlessly suffer those future flares, the utilization of an inhibitor of interleukin-one alpha beta that's very well tolerated with high efficacy is being very well received by both patients and healthcare professionals. So we are pleased to see an increase across really the whole population, which is a total of forty thousand patients in totality when you include the first recurrence on top of the two plus recurrence groups.

Speaker 5

Thanks so much for taking our question.

Operator

Thank you. And our next question comes from the line of Jeff Mecham from Citi. Your question please.

Speaker 4

Hey guys. Thanks for the question. I just want

Speaker 6

to, I guess, follow-up on Anupam's question.

Speaker 4

I guess when you look

Speaker 6

at the patients who've dropped off maybe over, say, the past year or so, was the dose and frequency a big driver? I guess I'm trying to get a sense for what the new start outlook could be for three eighty seven? And I'm under the assumption that you'll have a pretty good switch rate as well looking from ArcLast. Thank you.

Speaker 3

Thanks, Jeff. So we're seeing the patients continuing to stay on therapy for quite some time. We've seen an average of thirty months in total. Patients are also pretty compliant to therapy overall at eighty five percent or more. And patients are reacting very well while on ARCHONIS.

Speaker 3

So we're pleased about that. And we believe that there's a significant opportunity ahead for Arclis as we continue to switch on more and more physicians. And when you take the penetration numbers of fifteen percent, I think that shows that we've had good growth up until this moment in time, but the opportunity ahead is significant and that's without taking into account the first recurrence patients. So we're very focused on continuing the growth of Arclis. Maybe I'll pause there.

Speaker 3

Stans, you want to comment on March?

Speaker 2

Yeah, no thanks Jeff. I mean, obviously we're very excited about March and we are definitely cracking on as far as the phase two, three study is concerned. 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. So that'll be key, but ultimately dependent on data.

Speaker 2

But we certainly know how to do it. And as I said, we've leveraged a lot of the learnings we had from Rhapsody and from Arclis earlier on. So we'll continue to keep working on.

Speaker 1

Okay. Thanks guys.

Operator

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

Speaker 5

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 and or some sort of larger form of marketing slash DTC to continue to expand awareness and drive penetration? And my second question is with three eighty seven, how are you thinking about potential in office utilization in the future as part of the paradigm? Do you vision this potentially being more administered in office and just how you're thinking about self administration versus physician administration down the road here.

Speaker 5

Thank you very much.

Speaker 2

Thanks, Paul. This is Tom. Maybe I'll make a few comments and pass over to Ross if he has anything

Speaker 7

to add.

Speaker 2

But yes, very excited about the growth that we've had in Arcelis without a doubt. And as far as the Salesforce 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. And we've done that, as you know, launch just over four years ago. And as you've heard in the past, we have increased that. So at the moment really, we've not made any comments as to exactly what we've done on the size of it.

Speaker 2

Last report it was around 85. We're certainly continuing to look at what's needed as far as growth is concerned, but I think they're being utilized incredibly well. And as far as DCC and other things, clearly our marketing groups had a great impact in the launch so far. 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 in our existing materials and disease education, physician education, we continue to look at other ways.

Speaker 2

I'm sure Russ 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 are very much in need. So 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're certainly all tapping into that in the future.

Speaker 2

But maybe Ross, you can comment on how we're looking at marketing and expanding our assets there.

Speaker 3

Yeah, absolutely. Thanks, Sanjay. Thank you, Paul. Yeah, I think the key thing here on top of what Sanjay said is we're an organization that never rests on our laurels. We're quite happy with how the launch has gone to date.

Speaker 3

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 in our targeting strategy and in a variety of different digital marketing environments.

Speaker 3

And that's proven very successful for us. And 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. So 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 ARP List is in outpatients under pharmacy benefits. With KPR3A7, obviously, as Sanjay said, everything is data dependent and we'll see as we progress further, but with a target profile of monthly and in a liquid formulation with the potential to go to an auto injector.

Speaker 3

That also plays nicely into the where the patients are, which is 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. So whether that precipitates a change in kind of in office versus outpatients and patient administered in their own home is to be seen. But we don't see a substantial call for in hospital utilization.

Speaker 5

Okay, great. Thank you for taking our questions.

Operator

Thank you. And our next question comes from the line of Viva Forteo from Wells Fargo. Your question, please.

Speaker 8

Good morning. Congrats on the quarter and thanks for taking our questions. Two quick ones from us. So, on ArcLis from the thirty month average therapy duration, can you give us a sense in terms of numbers on how are you seeing a shorter treatment duration to patients in first recurrence versus patients in second and beyond? And the second question is on March.

Speaker 8

Can you discuss how you're thinking about like the balance between remaining cash flow positive on an annual basis and initiating studies in new indications beyond recurrent pericarditis? Thanks.

Speaker 3

Thanks, Eva. Thank you very much for the question. So I'll certainly take the first part and then hand over to someone else to cover the second part. Yes, 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. But of course, the data is always evolving and building.

Speaker 3

And as more patients starting to be initiated on Arcolyst earlier on in the disease, we just don't have some of that data yet, but it will build and we'll report as we see it later down the line. But from what we see so far, no significant differences. The average is thirty months. The median of the initial duration of therapy is around seventeen months and the restart rates remains around forty five percent. I think importantly, all those patients that started Arclis in our launch quarter back in 2021 now, around ten percent 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 Arclis can be for many of these patients.

Speaker 3

So no significant differences today. It's obviously something that we will keep an eye on and report as we see.

Speaker 4

And 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. And 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 Arpless to further advance our pipeline and or to pursue strategic initiatives.

Speaker 8

Got it. Thanks.

Operator

Thank you. Our next question comes from the line of Roger Song from Jefferies. Your question please.

Speaker 7

Great. Congrats for the quarter and thank you for taking our question. Maybe two quick ones for the pipeline. The first one, GPL-three eighty seven. So, understanding you are doing the Phase II portion to decide the dosing, just curious about what is the target efficacy profile, particularly in the context of comparison to alkalis, you can make a decision to decide a dose and how likely you will move multiple dose into the phase three portion, something like induction maintenance.

Speaker 7

And then a quick one for the $11.61 IND enabling right now, and then what's the current thinking about potential indication for this quarterly IL-one? Thank you.

Speaker 9

Yeah, thanks for that question. Actually both of those questions. So regarding the profile of KTL-three eighty seven, 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. And so 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 Arclist and that we're looking for similar profiles, if you will, with regard to the KPL-three eighty seven efficacy. So 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, in terms of the endpoints that we have structured.

Speaker 9

And so at that point, it'll be data driven in terms of what the actual profile of KPL-three eighty seven is. But we're very confident in the study design as being able to show the strength of KPL-three eighty seven and its target profile of once monthly dosing. Regarding the second question of November, at this point, we've not announced any specific indication. We realize that there's broad potential of having an IL-one alpha, IL-one beta inhibitor pathway inhibition, if you will, that has a target profile of dosing every three months. And so that really opens the possibility of a range of chronic lifelong diseases that are auto inflammatory.

Speaker 9

So 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 in human study as soon as possible. Thank you so much.

Speaker 5

Thank you.

Operator

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

Speaker 10

Hey, thanks for taking the question. I had two and maybe one is kind of a follow-up to the last one, but is there any specific kind of efficacy boundaries that you're looking for out of the March study? So, of course, AHRQ was showed at, you know, near 100% drop off in recurrences. I mean, 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? And then I had another question on just, you know, emerging competition.

Speaker 10

You know, there's a potential oral competitor out there that's going to report out data, you know, this half. Is there thinking on that or any thoughts on how we should think about the potential competition emerging? Thanks.

Speaker 9

Thanks, David. Appreciate the questions. So regarding the efficacy profile in the Phase studies, the dose focusing portion, we're really looking across a range of different dose levels in order to understand the performance characteristics of KPL3D7. And so in that sense, we intend to use the totality of the data in order to define the dose level that we'll take forward. So 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'll help us optimize the performance of the drug.

Speaker 9

Regarding competition that's

Speaker 3

on the

Speaker 9

horizon, we remain the leaders in this 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-one alpha and IL-one beta inhibition is a critical element for maintaining control of the disease, an important fact to be able to maintain control of the disease as monotherapy. And so we continue to look with interest to see other data as they emerge, but understanding those, shall we say 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. Thank you.

Speaker 3

Thanks.

Operator

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

Speaker 2

Thank you operator and thanks 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. So 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.

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