Q1 2026 Kiniksa Pharmaceuticals International PLC Earnings Call

April 28, 2026

Operator 1: Good day, and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals Q1 2026 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. Please be advised today's conference is being recorded. I would now like to hand the conference over to speaker today, Jonathan Kirshenbaum, Investor Relations. Please go ahead.

Operator: Good day, and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals Q1 2026 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. Please be advised today's conference is being recorded. I would now like to hand the conference over to speaker today, Jonathan Kirshenbaum, Investor Relations. Please go ahead.

Speaker #1: After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star 11 on your telephone.

Speaker #1: We will then hear an automated message advising your hand is raised to withdraw your question. Please press star 11 again. Please be advised today's conference is being recorded.

Speaker #1: I would now like to end the conference over to your speaker today, Jonathan Kirshenbaum, investor relations. Please go ahead. Thank you, operator. Good morning, everyone, and thank you for joining Kiniksa's call to discuss our first quarter 2026 financial results and recent portfolio execution.

Jonathan Kirshenbaum: Thank you, operator. Good morning, everyone, and thank you for joining Kiniksa's call to discuss our first quarter 2026 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investor 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 ARCALYST commercial execution. Kiniksa's Chief Medical Officer, John Paolini, will review our KPL-387 development program and the ongoing Phase 2/3 clinical trial in recurrent pericarditis. After that, Mark Ragosa, our Chief Financial Officer, will review our first quarter 2026 financial results. Finally, Sanj will share closing remarks and kick off the Q&A session, for which Eben Tessari, our Chief Strategy Officer, will also be on the line.

Speaker #1: A press release highlighting these results can be found on our website, under the investors section. As for the agenda, our chief executive officer, Sanj Patel, will start with an introduction.

Speaker #1: From there, Ross Moat, our chief operating officer, will provide an update on our list commercial execution. Then, Kiniksa's chief medical officer, Dr. Jon Paolini, will review our KPL 387 development program and the ongoing phase two, three clinical trial and recurrent pericarditis.

Speaker #1: After that, Mark Ragosa, our chief financial officer, will review our first quarter 2026 financial results. And finally, Sanj will share closing remarks and kick off the Q&A session.

Speaker #1: For which Evan Tesari, our chief strategy 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.

Jonathan Kirshenbaum: 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. 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'll turn it over to Sanj.

Speaker #1: 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.

Speaker #1: 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'll turn it over to Sanj.

Sanj K. Patel: Thanks, Jonathan. Good day, everyone. Kiniksa continues to build strength across the business, which is driven by both our commercial progress with ARCALYST and the advancement of our pipeline programs, including KPL-387 and KPL-1161. On the commercial side, the end of Q1 marks the fifth anniversary of the FDA approval for ARCALYST in recurrent pericarditis. Through our consistent and effective execution over those past 5 years, we've established and developed the market for this debilitating disease. This has enabled a fundamental shift in the treatment paradigm for patients and led to significant growth for the ARCALYST franchise. Within our clinical portfolio, we continue to advance the KPL-387, phase 2/phase 3 study in recurrent pericarditis. Data from the phase 2 dose focusing portion of the study are on track for H2 of this year.

Speaker #1: Thanks, Jonathan, and good day, everyone. Kiniksa continues to build strength across the business, which is driven by both our commercial progress with our clients and the advancement of our pipeline programs including KPL 387 and KPL 1161.

Speaker #1: On the commercial side, the end of the first quarter marks the fifth anniversary of the FDA approval for our clients in recurrent pericarditis. Through our consistent and effective execution over those past five years, we've established and developed the market for this debilitating disease.

Speaker #1: This has enabled a fundamental shift in the treatment paradigm for patients, and led to significant growth for the our clients franchise. Within our clinical portfolio, we continue to advance the KPL 387 phase two, phase three study in recurrent pericarditis.

Speaker #1: Data from the phase two dose focusing portion of the study are on track for the second half of this year. We also expect to start the phase three portion of the program by the end of this year.

Sanj K. Patel: We also expect to start the Phase 3 portion of the program by the end of this year. In addition, we are advancing KPL-1161 closer to the clinic. This is our Fc-modified IL-1 alpha and beta inhibitor with a target profile of quarterly dosing, and as we've previously shared, we plan to start a Phase 1 study by the end of this year. Our robust financial position, together with profitable ARCALYST revenue growth, gives us the ability to invest in value creation across the business. Commercially, ARCALYST continues to be on a robust trajectory 5 years from launch, and we intend to capture the additional opportunity that remains across the recurrent pericarditis market. Adoption of long-term IL-1 alpha and beta inhibition with ARCALYST is expanding in the approximately 40,000 patients each year in the United States who experience recurrent pericarditis flares.

Speaker #1: In addition, we are advancing KPL 1161 closer to the clinic. This is our FC-modified IL-1 alpha and beta inhibitor with a target profile of quarterly dosing, and as we've previously shared, we plan to start a phase one study by the end of this year.

Speaker #1: Our robust financial position, together with profitable our clients revenue growth, gives us the ability to invest in value creation across the business. Commercially, our clients continues to be on a robust trajectory five years from launch.

Speaker #1: And we intend to capture the additional opportunity that remains across the recurrent pericarditis market. Adoption of long-term IL-1 alpha and beta inhibition with our clients is expanding in the approximately 40,000 patients each year in the United States who experience recurrent pericarditis flares.

Speaker #1: In the first quarter of this year, this expanding adoption contributed to our clients' sales growing to $214.3 million. Looking to the rest of the year, the market increase in both the breadth and depth of prescribing we observed in the first quarter provides momentum going forward.

Sanj K. Patel: In the first quarter of this year, this expanding adoption contributed to ARCALYST sales growing to $214.3 million. Looking to the rest of the year, the marked increase in both the breadth and depth of prescribing we observed in the first quarter provides momentum going forward. As a result, we've now raised our full year 2026 revenue guidance to $930 to 945 million from our previous guidance of $900 to 920 million. In summary, Kiniksa is a well-capitalized, growth-orientated company that is well-positioned to maximize the substantial ARCALYST commercial opportunity that is available to us. The company's portfolio of programs have numerous milestones throughout the rest of the year, and that also have the potential to create meaningful value. Now, Ross Moat.

Speaker #1: As a result, we've now raised our full year 2026 revenue guidance to $930 to $945 million from our previous guidance of $900 to $920 million.

Speaker #1: In summary, Kiniksa is a well-capitalized, growth-oriented company that is well positioned to maximize the substantial commercial opportunity that is available to us.

Speaker #1: The company's portfolio programs have numerous milestones throughout the rest of the year, but also have the potential to create meaningful value. And now, Ross Moat.

Speaker #2: Thank you, Sanj. I'll continue the commercial execution has driven strong revenue growth in Q1, leading to an our clients' net revenue of $214.3 million.

Ross Moat: Thank you, Sanj. Our continued commercial execution has driven strong revenue growth in Q1, leading to an ARCALYST net revenue of $214.3 million, which represents an increase of more than $76 million compared to Q1 2025, and approximately $12 million over Q4 of last year. This revenue growth was driven by strong underlying commercial metrics, which outpaced the Q1 industry-wide headwinds related to co-pay resets and changes in insurance plans. In particular, growth was achieved by two key commercial dynamics. Firstly, we saw an acceleration in the growth of new prescribers through the quarter, which resulted in the highest quarterly increase in new patient enrollments since launch.

Speaker #2: Which represents an increase of more than 76 million dollars compared to the first quarter 2025 and approximately $12 million over Q4 of last year.

Speaker #2: This revenue growth was driven by strong underlying commercial metrics, which outpaced the Q1 industry-wide headwinds related to copay resets and changes in insurance plans.

Speaker #2: In particular, growth was achieved by two key commercial dynamics. Firstly, we saw an acceleration in the growth of new prescribers through the quarter, which resulted in the highest quarterly increase in new patient enrollments since launch.

Speaker #2: This bodes particularly well for the rest of the year as the new, larger prescribing base along with the durability of average duration of therapy has enabled us to increase our full year revenue guidance from between $900 to $920 million to between $900 and $30 and $945 million.

Ross Moat: This bodes particularly well for the rest of the year as the new, larger prescriber base, along with the durability of average duration of therapy, has enabled us to increase our full year revenue guidance from between $900 to $920 million to between $930 and $945 million. Secondly, in Q1, our gross-to-net increased compared to the prior quarter as expected. However, it was lower than Q1 of 2025. This was mainly driven by changes to our co-pay support program, where we made enhancements to our assistance program design, which reduced the average co-pay payout per patient relative to prior Q1s.

Speaker #2: Secondly, in Q1, our gross-to-net increased compared to the prior quarter as expected. However, it was lower than Q1 of 2025. This was mainly driven by changes to our copay support program, where we made enhancements to our assistance program design, which reduced the average copay payout per patient relative to prior Q1s.

Speaker #2: With the momentum created early in the year, combined with our strong underlying commercial foundation, we believe we are well positioned to continue driving our clients' growth through the rest of the year, and believe there is substantial opportunity ahead to support many more recurrent pericarditis patients.

Ross Moat: With the momentum created early in the year, combined with our strong underlying commercial foundation. We believe we are well-positioned to continue driving ARCALYST growth through the rest of the year and believe there is substantial opportunity ahead to support many more recurrent pericarditis patients. In Q1, thanks to the strong execution from our team, approximately 400 new prescribers wrote ARCALYST for the first time, representing the highest quarter-on-quarter increase launch to date. This brings the total number of prescribers to more than 4,550. As a reminder, with more than 25,000 healthcare professionals seeing recurrent pericarditis patients in a given year, there is substantial opportunity ahead. We also saw growth in the number of healthcare professionals who became repeat prescribers during Q1, resulting in approximately 1,320 prescribers in total who have now prescribed ARCALYST multiple times.

Speaker #2: In Q1, thanks to the strong execution from our team, approximately 400 new prescribers wrote our clients for the first time, representing the highest quarter-on-quarter increase launched to date.

Speaker #2: This brings the total number of prescribers to more than 4,550. As a reminder, with more than 25,000 healthcare professionals seeing recurrent pericarditis patients in a given year, there is substantial opportunity ahead.

Speaker #2: We also saw growth in the number of healthcare professionals who became repeat prescribers during Q1, resulting in approximately 1,320 prescribers in total who have now prescribed our clients multiple times.

Speaker #2: The acceleration we've seen in both the breadth and the depth of prescribing reflects our continued commercial execution as well as the growing understanding and adoption of interleukin-1 alpha and beta inhibition as the treatment choice following the prior use of NSAIDs and colchicine, as recommended in the 2025 ACC Concise Clinical Guidance.

Ross Moat: The acceleration we've seen in both the breadth and the depth of prescribing reflects our continued commercial execution, as well as the growing understanding and adoption of interleukin-1 alpha and beta inhibition as the treatment choice following the prior use of NSAIDs and colchicine, as recommended in the 2025 ACC Concise Clinical Guidance. Earlier this month, we announced the initiation of our highly targeted direct-to-consumer campaign, Heart's Home. This campaign is designed to identify and target patients who may be suffering with recurrent pericarditis and not currently taking ARCALYST, with the aim of empowering them to discuss ARCALYST with their healthcare provider. Through digital innovation, including the use of AI, we are able to deploy DTC in a way that's cost-effective, highly targeted, and ultimately applicable for a rare disease market.

Speaker #2: Earlier this month, we announced the initiation of our highly targeted direct-to-consumer campaign, Hearts Home. This campaign is designed to identify and target patients who may be suffering with recurrent pericarditis and not currently taking our clients, with the aim of empowering them to discuss our clients with their healthcare provider.

Speaker #2: Through digital innovation, including the use of AI, we are able to deploy DTC in a way that's cost-effective and highly targeted, and ultimately applicable for a rare disease market.

Speaker #2: We have focused on utilizing our existing patient database and added search optimization and machine learning models informed by de-identified claims, demographics, and consumer market data to define an enriched population of potential recurrent pericarditis patients to deliver tailored content.

Ross Moat: We have focused on utilizing our existing patient database and added search optimization and machine learning models informed by de-identified claims, demographics, and consumer market data to define an enriched population of potential recurrent pericarditis patients to deliver tailored content, opposed to a traditional DTC approach of broad scale and high-cost marketing. The centerpiece of our campaign is a connected TV commercial that is directed to potential patients through their individual streaming accounts on platforms such as YouTube and Hulu, as well as across social media channels. This campaign is informed by our market research, which demonstrated that when a recurrent pericarditis patient inquires about ARCALYST to their provider, the healthcare professional is receptive to the inquiry, and it results in ARCALYST being prescribed in around 80% of cases.

Speaker #2: Opposed to a traditional DTC approach of broad-scale and high-cost marketing. The centerpiece of our campaign is a connected TV commercial that is directed to potential patients through their individual streaming accounts on platforms such as YouTube and Hulu, as well as across social media channels.

Speaker #2: This campaign is informed by our market research, which demonstrated that when a recurrent pericarditis patient inquires about our clients to their provider, the healthcare professional is receptive to the inquiry, and it results in our clients being prescribed in around 80% of cases.

Ross Moat: As previously mentioned, our ARCALYST franchise is growing, is profitable, and has significant opportunity ahead. This has allowed us to make disciplined investment decisions to expand our reach to capture the opportunity and help more patients. With that, I'll turn the call over to John to cover our KPL-387 development program.

Speaker #2: As previously mentioned, our our clients' franchise is growing, is profitable, and has significant opportunity ahead, and this has allowed us to make disciplined investment decisions to expand our reach to capture the opportunity and help more patients.

Speaker #2: With that, I'll turn the call over to John to cover our KPL 387 development program.

Speaker #1: Thank you, Ross. As a brief refresher, we leveraged our extensive clinical experience with the IL-1 signaling pathway when designing the integrated development program for KPL-387 shown here, broken down by phase of development.

John Paolini: Thank you, Ross. As a brief refresher, we leverage our extensive clinical experience with the IL-1 signaling pathway when designing the integrated development program for KPL-387, shown here, broken down by phase of development. The core component of the program is the Phase 3 placebo-controlled, event-driven randomized withdrawal study. Just as in RHAPSODY, the pivotal study which supported ARCALYST approval in recurrent pericarditis, the primary efficacy endpoint for Phase 3 will measure the reduction in risk of pericarditis recurrence as the primary demonstration of KPL-387 efficacy for the label. We believe from our regulatory interactions that this study will be sufficient to support registration as a single pivotal study.

Speaker #1: The core component of the program is the phase three placebo-controlled event-driven randomized withdrawal study. Just as in Rapsody, the pivotal study which supported our clients' approval pericarditis, the primary efficacy endpoint for phase three will measure the reduction in risk of pericarditis recurrence as the primary demonstration of KPL 387 efficacy for the label.

Speaker #1: We believe from our regulatory interactions that this study will be sufficient to support registration as a single pivotal study. As a reminder, to maximize operational efficiency, we combined the phase two dose focusing trial and the phase three pivotal trial into a single integrated phase two three protocol, so that phase three could initiate independently of phase two execution.

John Paolini: As a reminder, to maximize operational efficiency, we combined the phase 2 dose focusing trial and the phase 3 pivotal trial into a single integrated phase 2/3 protocol so that phase 3 could initiate independently of phase 2 execution, and we added long-term extensions to all trial activities. We previously guided that we expect data from the dose focusing study outlined here in red in the H2 of this year, and today, we guided that we expect to initiate the phase 3 portion of the study by the end of this year. The phase 2 dose focusing study builds on insights from previous clinical trials with rilonacept, and it is designed to define the KPL-387 PK/PD relationship as well as to support the data-driven approach for affirming the dose level for the phase 3 pivotal trial.

Speaker #1: And we added long-term extensions to all trial activities. We previously guided that we expect data from the dose focusing study outlined here in red in the second half of this year, and today we guided that we expect to initiate the phase three portion of the study by the end of this year.

Speaker #1: The phase two dose focusing study builds on insights from previous clinical trials with Relonisept. And it is designed to define the KPL 387 PK-PD relationship, as well as to support the data-driven approach for affirming the dose level for the phase three pivotal trial.

Speaker #1: Looking at the Relonisept phase two precedent in the left panels, the single active arm study demonstrated that IL-1 pathway inhibition with once weekly Relonisept resulted in rapid and sustained reductions in reported pain and inflammation in patients with active recurrent pericarditis and elevated C-reactive protein over the initial six-week treatment period, as well as the subsequent long-term extension through 24 weeks.

John Paolini: Looking at the rilonacept Phase 2 precedent in the left panels. The single active arm study demonstrated that IL-1 pathway inhibition with once-weekly rilonacept resulted in rapid and sustained reductions in reported pain and inflammation in patients with active recurrent pericarditis and elevated C-reactive protein over the initial 6-week treatment period, as well as the subsequent long-term extension through 24 weeks. Now, looking forward, the KPL-387 Phase 2 dose focusing study, which is assessing 4 dose levels in up to 20 patients per arm, mirrors the rilonacept Phase 2 study in terms of study population, number of patients per arm, and the primary endpoint, which is time to treatment response. The study framework has been adjusted for the specific attributes of the long-acting pharmacokinetics of KPL-387.

Speaker #1: Now, looking forward, the KPL 387 phase two dose focusing study which is assessing four dose levels in up to 20 patients per arm mirrors the Relonisept phase two study in terms of study population number of patients per arm, and the primary endpoint which is time to treatment response.

Speaker #1: The study framework has been adjusted for the specific attributes of the long-acting pharmacokinetics of KPL 387. Thus, development stage appropriate data which are expected in the second half of this year are designed to provide useful information on the cadence and magnitude of initial response as well as the duration of action of KPL 387 dose levels, affirming the dose level for phase three and informing phase three outcomes measures.

John Paolini: Development stage appropriate data, which are expected in H2 of this year, are designed to provide useful information on the cadence and magnitude of initial response, as well as the duration of action of KPL-387 dose levels, affirming the dose level for Phase 3 and informing Phase 3 outcomes measures. I will now turn it over to our Chief Financial Officer. Mark?

Speaker #1: I will now turn it over to our chief financial officer. Mark?

Speaker #3: Thanks, John. This morning I will cover our first quarter 2026 financial performance. As always, you can find our detailed financial information in today's press release.

Mark Ragosa: Thanks, John. This morning I will cover our Q1 2026 financial performance. As always, you can find our detailed financial information in today's press release. In Q1 2026, we continued to build strong momentum across the business, advancing ARCALYST, progressing our clinical portfolio, and maintaining a strong financial position. Starting on the left-hand side of this slide with our income statement. As you've heard from Sanj and Ross, ARCALYST revenue grew 56% year over year to $214.3 million in Q1. This growth was driven by strong expansion in new prescribers and new patient enrollments, which more than offset the impact of industry-wide seasonal headwinds. Operating expense growth year over year was driven by several factors. Higher cost of goods sold due to ARCALYST revenue growth.

Speaker #3: In the first quarter of 2026, we continue to build strong momentum across the business, advancing our clients' progressing our clinical portfolio and maintaining a strong financial position.

Speaker #3: Starting on the left-hand side of this slide with our income statement, as you've heard from Sanj and Ross, our clients' revenue grew 56% year over year to $214.3 million in the first quarter.

Speaker #3: This growth was driven by strong expansion in new prescribers and new patient enrollments which more than offset the impact of industry-wide seasonal headwinds. Operating expense growth year over year was driven by several factors.

Speaker #3: Higher cost of goods sold due to our clients' revenue growth, increased collaboration expenses aligned with higher our clients' revenue and collaboration profit, higher R&D primarily due to increased clinical and manufacturing costs associated with the development of KPL 387, and additional SG&A primarily driven by investment associated with the commercialization of our clients' including personnel and leveraging new technologies to enhance our targeting strategy and reach additional patients in HCPs.

Mark Ragosa: Increased collaboration expenses aligned with higher ARCALYST revenue and collaboration profit. Higher R&D, primarily due to increased clinical and manufacturing costs associated with the development of KPL-387. Additional SG&A, primarily driven by investment associated with the commercialization of ARCALYST, including personnel and leveraging new technologies to enhance our targeting strategy and reach additional patients and HCPs. As a result of the strong revenue growth against more moderate expense growth, net income increased significantly to $22.6 million in Q1 2026, compared to $8.5 million in Q1 2025. Turning to the right-hand side of this slide, you'll find the calculation for ARCALYST collaboration profit, which drives total collaboration expenses.

Speaker #3: As a result of the strong revenue growth against more moderate expense growth, net income increased significantly to $22.6 million in the first quarter of 2026 compared to $8.5 million in the first quarter of 2025.

Speaker #3: Turning to the right-hand side of this slide, you'll find the calculation for our clients' collaboration profit, which drives total collaboration expenses. In the first quarter of 2026, our clients' collaboration profit continued to grow faster than sales on a year-over-year basis.

Mark Ragosa: In Q1 2026, ARCALYST collaboration profit continued to grow faster than sales on a year-over-year basis, up 73% to $151.2 million. At the bottom of this slide, we ended Q1 with a $468.1 million cash balance, representing $54 million of net cash generation for the period. We expect to remain cash flow positive on an annual basis under our current operating plan, enabling us to continuing to help patients while creating additional value in both the near and long term. With that, I will turn the call back to Sanj for closing remarks.

Speaker #3: Up 73% to $151.2 million. Finally, at the bottom of this slide, we ended the first quarter with a $468.1 million cash balance. Representing $54 million of net cash generation for the period.

Speaker #3: We expect to remain cash flow positive on an annual basis under our current operating plan, enabling us to continue to help patients while creating additional value in both the near and long term.

Speaker #3: With that, I will turn the call back to Sanj for closing remarks.

Speaker #1: Thanks, Mark. As you've heard, Kiniksa is well positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. We are dedicated to helping as many patients as possible with our clients and to advancing the development of our clinical portfolio in order to bring additional therapies to patients suffering from debilitating diseases.

Sanj K. Patel: Thanks, Mark. You've heard, Kiniksa is well-positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. We are dedicated to 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 suffering from debilitating diseases. With that, I'll now turn the call back to the operator for questions. Operator?

Speaker #1: With that, I'll now turn the call back to the operator for questions. Operator?

Speaker #4: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again.

Operator 1: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press star one one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Nicholas LaRosa with TD Cowen. Your line is open.

Operator: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press star one one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Nicholas LaRosa with TD Cowen. Your line is open.

Speaker #4: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Nicholas, so with TD Cowan, your line is open.

Nicholas LaRosa: Great. Thanks very much for taking our question, and congrats on the strong quarter. Can you discuss what you have seen in terms of increased demand from the early days of the DTC campaign, acknowledging that it is still pretty early on? And what other plans do you have to accelerate demand in future, either via patients or prescriber targeting? Thanks very much.

Nick Lorusso: Great. Thanks very much for taking our question, and congrats on the strong quarter. Can you discuss what you have seen in terms of increased demand from the early days of the DTC campaign, acknowledging that it is still pretty early on? And what other plans do you have to accelerate demand in future, either via patients or prescriber targeting? Thanks very much.

Speaker #5: Great. Thanks very much for taking our question and congrats on the strong quarter. Can you discuss what you have seen in terms of increased demand from the early days of the DTC campaign, acknowledging that it is still pretty early on?

Speaker #5: And what other plans do you have to accelerate demand in the future, either via patients or prescriber targeting? Thanks very much.

Speaker #1: Yeah. Hi, Nick. This is Ross. I'll take a pause from that, so thank you very much. Yeah, as you said, it's early on for the DTC campaign.

Ross Moat: Yeah. Hi, Nick. This is Ross. I'll take a pass on that. Thank you very much. Yeah, as you said, it's early on for the DTC campaign. We just announced it pretty recently that we're focusing on DTC in a very targeted way in order to go and try and reach patients who we believe are recurrent pericarditis patients, and in order to kind of inform them and educate them in how to go and speak with their healthcare providers about the potential of ARCALYST and recurrent pericarditis. It's early days. One thing that I share with you is that, you know, while we also understand that when patients go in and speak to their healthcare professionals proactively about ARCALYST, it gets, you know, prescribed.

Speaker #1: We just announced it pretty recently. We're focusing on DTC in a very targeted way. In order to go and try and reach patients who we believe with current pericarditis patients and in order to kind of inform them and educate them in how to go and speak with their healthcare providers about the potential of our clients and recurrent pericarditis.

Speaker #1: So it's early days. One thing that I share with you is that while we also understand that when patients go in and speak to their healthcare professionals proactively about our clients, it gets prescribed.

Speaker #1: The patients get prescribed our clients in around 80% of the cases. It's also true that there's only around 14% of recurrent pericarditis patients who are actually unaided aware of our clients.

Ross Moat: The patients get prescribed ARCALYST in around 80% of the cases. It's also true that there's only around 14% of recurrent pericarditis patients who are actually unaided aware of ARCALYST. We know that there's a big awareness gap out there with patients. We know patients are very widely dispersed across the country. This is our approach of ours of going out, trying to identify those patients and serve up appropriate, very targeted, very tailored messages that can help appropriate patients to be empowered to go and speak to their healthcare professionals about ARCALYST. We're excited about the campaign, but as you said, it's early days. We are focused on many different initiatives to accelerate the growth.

Speaker #1: So we know that there's a big awareness gap out there with patients. We know patients are very widely dispersed across the country. So this is our approach of ours of going out, trying to identify those patients and serve up appropriate, very targeted, very tailored messages that can help appropriate patients to be empowered to go and speak to their healthcare professionals about our clients.

Speaker #1: So, we're excited about the campaign; but as you said, it's early days. We are focused on many different initiatives to accelerate the growth. As a reminder, last announced, we were around 18% penetrated into the 14,000-patient population—not accounting for patients that are even in their first recurrence.

Ross Moat: As a reminder, last announce, we were around 18% penetrated into the 14,000 patient population, not accounting for patients that are even in their first recurrence. As you know, we've seen a strong growth in patients on their first recurrence as well over time. The opportunity is very significant. We're focused on continuing to execute incredibly well across our commercial organization. We're focused obviously on digital marketing, of which the DTC campaign is a part of that, a much broader umbrella of digital marketing. We're also focused on peer-to-peer education and growing, you know, this new wave of how to treat recurrent pericarditis patients, which has been, you know, really transforming over the last 5 years of the availability of ARCALYST on the market. We're very excited about the future.

Speaker #1: And as you know, we've seen strong growth in patients on their first recurrence as well over time. So the opportunity is very significant.

Speaker #1: We're focused on continuing to execute incredibly well across our commercial organization. We're focused, obviously, on digital marketing, of which the DTC campaign is a part of that, a much broader umbrella of digital marketing.

Speaker #1: And we're also focused on peer-to-peer education and growing this new wave of how to treat recurrent pericarditis patients, which has been really transforming over the last five years of the availability of our clients on the market.

Ross Moat: We're also focused on peer-to-peer education and growing, you know, this new wave of how to treat recurrent pericarditis patients, which has been, you know, really transforming over the last 5 years of the availability of ARCALYST on the market. We're very excited about the future. We have a multifaceted approach to how we're gonna continue to grow the breadth and the depth of prescribing and help more and more patients.

Speaker #1: So we're very excited about the future. We have a multifaceted approach to how we're going to continue to grow the breadth and the depth of prescribing and help more and more patients.

Ross Moat: We have a multifaceted approach to how we're gonna continue to grow the breadth and the depth of prescribing and help more and more patients.

Speaker #5: Very helpful. Thank you very much.

Nicholas LaRosa: Very helpful. Thank you very much.

Nick Lorusso: Very helpful. Thank you very much.

Operator: One moment for our next question. Our next question comes from Anupam Rama with J.P. Morgan. Your line is open.

Speaker #4: One moment before our next question comes from Anupam Rama, with JPMorgan. Your line is open.

Anupam Rama: Hey, guys. Thanks so much for taking the question and congrats on a strong quarter here. For KPL-387 and the H2 dose focus update, John, I was wondering if you could comment a little bit as when you look at the totality of the range of endpoints and assessments that you're going to be looking at in Phase 2, how do you think about which ones are most important in sort of the ultimate dose selection moving to Phase 3? Thanks so much.

Speaker #6: Hey, guys. Thanks so much for taking the question and congrats on a strong quarter here. For KPL 387 and the second half dose focus update, John, I was wondering if you could comment a little bit as when you look at the totality of the range of endpoints and assessments that you're going to be looking at in phase two, how do you think about which ones are most important in sort of the ultimate dose selection moving to phase three?

Speaker #6: Thanks so much.

John Paolini: Sure. Good morning, Anupam, and thank you for that question. Yes. With regard to the phase 2 trial, which is currently ongoing, the value I think of slide 13 is that it shows you what kind of data we had generated in the past in the phase 2 program with rilonacept in terms of 3 critical elements, which is of course the, what we call the cadence and magnitude, which is basically the time of onset of action and the degree of suppression of pain and the inflammation with C-reactive protein, and then the additional element of durability of response. And that's what we showed previously with rilonacept, carrying that forward to the KPL-387 program.

Speaker #5: Sure. Good morning, Anupam, and thank you for that question. Yes. So with regard to the phase two trial, which is currently ongoing, the value, I think, of slide 13 is that it shows you what kind of data we had generated in the past in the phase two program with Reliance.

Speaker #5: In terms of three critical elements which is, of course, what we call the cadence and magnitude, which is basically the time of onset of action and the degree of suppression of pain and the inflammation with C-reactive protein.

Speaker #5: And then the additional element of durability of response. And that's what we showed previously with Reliance. And so carrying that forward to the KPL 387 program, again, with that initial dose of KPL 387, what we've shown in our models regardless of the dose level selected, we expect to see a high drug levels which would be modeled to have a rapid cadence in terms of onset of action and magnitude of effect in suppressing the initial inflammatory response.

John Paolini: Again, with that initial dose of KPL-387, what we've shown in our models, regardless of the dose level selected, we expect to see high drug levels, which, you know, would be modeled to have a rapid cadence in terms of onset of action and magnitude of effect in suppressing the initial inflammatory response. The additional scientific question that we intend to glean by looking at the different dose levels is that duration of action of the 4 different dose levels that we take forward that we look at in the trial. From that, we integrate all 3 of those elements to build the PK/PD relationship and affirm what we believe to be the therapeutic concentration as well as the dose level that we would carry forward into Phase 3.

Speaker #5: And then the additional scientific question that we intend to glean by looking at the different dose levels is that duration of action of the four different dose levels that we take forward, that we look at in the trial.

Speaker #5: And then from that, we integrate all three of those elements to build the PKPD relationship and affirm the what we believe to be the therapeutic concentration as well as the dose level that we would carry forward into phase three.

John Paolini: It's really the integration of those three critical elements.

Speaker #5: So, it's really the integration of those three critical elements.

Speaker #4: Thanks so much for taking the question.

Anupam Rama: Thanks so much for taking the question.

Operator: One moment for our next question. Our next question comes from David Risinger with Wedbush Securities. Your line is open.

Speaker #5: One moment before our next question. Our next question comes from David Neergarten, Wedbush Securities. Your line is open.

Operator: One moment for our next question. Our next question comes from David Risinger with Wedbush Securities. Your line is open.

Speaker #7: Hey, thanks for taking the question. Just a couple of quick ones for me. First off, on the DTC ad, is it fair to model in the incremental spend year over year on marketing as the DTC component, or is there some additional sales guys or other folks that you hired or other expenses going in there?

David Risinger: Hey, thanks for taking the question. Just a couple quick ones from me. First off, on the DTC ad, is it fair to, you know, model in the incremental spend year-over-year on marketing as the DTC, you know, component? Or is there, you know, some additional sales guys or other folks that you've hired or other expenses going in there? The second one on 387, on the transition study, the treatment duration 16 weeks, you know, which is different than the 12 or 24 weeks, you know, that you've looked at in the Phase 1 or Phase 2. Is there any reason you picked 16 weeks versus, you know, having a little bit more apples-to-apples duration comparison, at least for patients who are moving from ARCALYST to 387?

David Nierengarten: Hey, thanks for taking the question. Just a couple quick ones from me. First off, on the DTC ad, is it fair to, you know, model in the incremental spend year-over-year on marketing as the DTC, you know, component? Or is there, you know, some additional sales guys or other folks that you've hired or other expenses going in there? The second one on 387, on the transition study, the treatment duration 16 weeks, you know, which is different than the 12 or 24 weeks, you know, that you've looked at in the Phase 1 or Phase 2. Is there any reason you picked 16 weeks versus, you know, having a little bit more apples-to-apples duration comparison, at least for patients who are moving from ARCALYST to 387? Thanks.

Speaker #7: And then the second one on 387, on the transition study, the treatment duration 16 weeks, which is different than the 12 or 24 weeks, that you've looked at in the phase one or phase two.

Speaker #7: Is there any reason you picked 16 weeks versus having a little bit more apples-to-apples duration comparison, at least for patients who are moving from our clients to 387?

Speaker #7: Thanks.

David Risinger: Thanks.

Sanj K. Patel: I mean, David Risinger, on the first one, I mean, I think as you heard us talk about on the call, you know, SG&A did go up as a result of sort of personnel-related expenses as well as sales and marketing initiatives, which Ross Moat has sort of covered. I mean, I think we continue to invest responsibly in the commercialization of ARCALYST, as shown by collaboration profit continuing to grow faster than revenue. I think as we, you know, we haven't really guided to spend, but I think it's worth sort of noting that on a percentage of sales basis, SG&A has been fairly consistent over the last year.

Mark Ragosa: I mean, David Risinger, on the first one, I mean, I think as you heard us talk about on the call, you know, SG&A did go up as a result of sort of personnel-related expenses as well as sales and marketing initiatives, which Ross Moat has sort of covered. I mean, I think we continue to invest responsibly in the commercialization of ARCALYST, as shown by collaboration profit continuing to grow faster than revenue. I think as we, you know, we haven't really guided to spend, but I think it's worth sort of noting that on a percentage of sales basis, SG&A has been fairly consistent over the last year.

Speaker #6: Maybe David on the first one. I mean, I think as you heard us talk about on the call, SG&A did go up as a result of sort of personnel-related expenses as well as sales and marketing issues, which Ross has sort of covered.

Speaker #6: I mean, I think we continue to invest responsibly in the commercialization of our clients as shown by collaboration profit continuing to grow faster than revenue.

Speaker #6: And so I think, as we haven't really guided to spend, I think it's worth sort of noting that, on a percentage of sales basis, SG&A has been fairly consistent over the last year.

Speaker #6: And then with regard to your question, David, thank you for that question about the transition to KPL 387 monotherapy dosing and administration study. So yes, the 16-week treatment duration for the posology portion of the study is, in fact, appropriate for this type of study.

John Paolini: With regard to your question, David, you know, thank you for that question about the transition to KPL-387 monotherapy dosing and administration study. Yes, the 16-week treatment duration for the posology portion of the study is in fact appropriate for this type of study. This study is really designed to look at well-controlled patients as they move from their prior therapies to KPL-387. In this study, patients are transitioning from regimens of NSAIDs and colchicine from corticosteroids and IL-1 pathway inhibitors, including anakinra and rilonacept. What we had seen previously with regard to rilonacept was a time to monotherapy of under 8 weeks in the RHAPSODY program.

Speaker #6: This study is really designed to look at well-controlled patients as they move from their prior therapies to KPL 387. And in this study, patients are transitioning from regimens of NSAIDs and colchicine from corticosteroids and IL-1 pathway inhibitors, including anakinra and Reliance.

Speaker #6: And so what we had seen previously with regard to Reliance was a time-to-monotherapy of under eight weeks in the rapidity program. And so this program is designed to basically move patients off of those other therapies onto KPL 387 and achieve monotherapy within that time window.

John Paolini: You know, this program is designed to basically move patients off of those other therapies onto KPL-387 and achieve monotherapy within that time window. Of course, there are additional doses that are administered to achieve steady state by the week 16 time point. Importantly, patients transition to a long-term extension where they can continue to receive KPL-387 for up to 2 total years. It's a well-designed study to inform that element of, you know, the label, if you will, a clinical practice for transitioning patients to KPL-387.

Speaker #6: And then, of course, there are additional doses that are administered to achieve steady state by the week 16 time point. But then, importantly, patients transition to a long-term extension where they can continue to receive KPL-387 for up to two total years.

Speaker #6: So, it's a well-designed study to inform that element of the label, if you will—clinical practice for transitioning patients to KPL-387.

David Risinger: Maybe a quick follow-up. Obviously, you look at the patients by prior treatment to determine, you know, if anyone has a new attack of pericarditis that, you know, of course you'll know which, you know, prior treatment they're on and you'll stratify accordingly or, you know, how are you thinking about the differences in prior treatments for, you know, the transition?

David Nierengarten: Maybe a quick follow-up. Obviously, you look at the patients by prior treatment to determine, you know, if anyone has a new attack of pericarditis that, you know, of course you'll know which, you know, prior treatment they're on and you'll stratify accordingly or, you know, how are you thinking about the differences in prior treatments for, you know, the transition?

Speaker #7: Maybe a quick follow-up. Is there obviously, you'll look at the patients by prior treatment to determine if anyone has a new attack of pericarditis that, of course, you'll know which prior treatment they're on, and you'll stratify accordingly or how are you thinking about the differences in prior treatments for the transition?

John Paolini: No, that's a very reasonable statement. If you look at, for example, the ARCALYST label, it covers all of the different therapies that patients can transition from. It talks about NSAIDs and colchicine, it talks about corticosteroids. We didn't do this study specifically for recurrent pericarditis for anakinra, because that had already been done for Ilaris. You know, what we reported in that trial was, you know, how patients responded across the different treatments and the time to monotherapy. Similarly, in this trial, of course, you would look at each one of those different types of dosing regimens that patients came from and then look to make sure that the transition to KPL-387 is robust.

Speaker #6: No, that's a very reasonable statement. And if you look at, for example, the our clients label it covers all of the different therapies that patients can transition from.

Speaker #6: So, it talks about NSAIDs and colchicine. It talks about corticosteroids. And then we didn’t do this study specifically for recurrent pericarditis or anakinra, because that had already been done for DIRA.

Speaker #6: And so what we reported in that trial was how patients responded across the different treatments and the time-to-monotherapy. So similarly, in this trial, of course, you would look at each one of those different types of dosing regimens that patients came from and then look to make sure that the transition to KPL 387 is robust.

John Paolini: Similarly, in this trial, of course, you would look at each one of those different types of dosing regimens that patients came from and then look to make sure that the transition to KPL-387 is robust. It's important to point out that the duration of action of KPL-387 with our anticipated phase 3 dose level is once monthly dosing, which covers you know, most of that initial transition period, depending on the therapy.

John Paolini: It's important to point out that the duration of action of KPL-387 with our anticipated phase 3 dose level is once monthly dosing, which covers-

Speaker #6: It's important to point out at the onset that the duration of action of KPL-387 with our anticipated Phase 3 dose level is once-monthly dosing, which covers most of that initial transition period depending on the therapy.

David Risinger: Mm-hmm

John Paolini: you know, most of that initial transition period, depending on the therapy.

David Risinger: Got it. Thanks.

David Nierengarten: Got it. Thanks.

Speaker #7: Got it. Thanks.

John Paolini: Mm-hmm.

Operator: One moment for our next question. Our next question comes from Edward Nash with Canaccord Genuity. Your line is open.

Speaker #4: One moment before our next question. Our next question comes from Edward Nash with Canaccord Genuity. Your line is open.

Edward Nash: Hi, good morning, guys, really great quarter. Congratulations. Wanted to ask, I know obviously the DTC program is relatively new, I just wanted to kind of understand with regards to what's driving the biggest change in new patient starts. You said that on awareness, the awareness gap has shrunk that you've seen increasing physician adoption. What effect has reimbursement or referral patterns had into this new patient starts?

Speaker #8: Hi, good morning, guys and really great quarter. Congratulations. So I wanted to ask, I know obviously the DTC program is relatively new. And you just wanted to kind of understand with regards to what's driving the biggest change in new patient starts.

Speaker #8: You said that on awareness, the awareness gap is shrinking and that you've seen increasing physician adoption. What effect have reimbursement or referral patterns had on new patient starts?

Ross Moat: Thanks, Ed. Appreciate your question. Yeah, there are lots of different things driving the increases that we've seen, not just in Q1, but over time as well. Of note, Q1 was the highest ever quarter-on-quarter growth that we've had in terms of new prescribers. It was also the highest ever since the time of our launch 5 years ago, the highest ever number of new patient enrollments or new prescriptions coming in for ARCALYST. Clearly, we're at a stage 5 years out from our launch where we're growing very nicely with a substantial opportunity ahead.

Speaker #6: Thanks, appreciate your question. So yeah, there are lots of different things driving the increases that we've seen, not just in Q1, but over time as well.

Speaker #6: But of note, Q1 was the highest ever quarter-on-quarter growth that we've had in terms of new prescribers is also the highest ever since the time of our launch five years ago.

Speaker #6: The highest ever number of new patient enrollments or new prescriptions coming in for our clients. So clearly, we're at a stage five years out from our launch where we're growing very nicely with a substantial opportunity ahead.

Ross Moat: Reimbursement continues to be very strong across all the different payer mixes, and that's both for new patients coming on as well as the revalidation of the script, usually after a 1-year time period. That continues to really be very positive. In terms of referrals, I think, you know, certainly there are some centers out there, around 18 centers that are centers of excellence, if you like, or whole pericardial disease-specific clinics. They're acknowledged partially under 1 program, which is the AHA's addressing recurrent pericarditis, of which, you know, we are a sponsor of. That's, you know, that's been a helpful initiative, I think, to grow the expertise and share expertise in how to diagnose and treat recurrent pericarditis over time among those 18 groups.

Speaker #6: Reimbursement continues to be very strong across all the different payer mixes and that's both for new patients coming on as well as the revalidation of the script, usually after a one-year time period.

Speaker #6: So that continues to really be very positive. In terms of referrals, I think certainly there are some centers out there around 18 centers that are centers of excellence, if you like, or a whole pericardial disease-specific clinics and they're acknowledged partially under one program, which is the AHA's Addressing Recurrent Pericarditis, of which we are a sponsor of.

Speaker #6: And that's been a helpful initiative, I think, to grow the expertise and share expertise in how to diagnose and treat recurrent pericarditis over time among those 18 groups.

Ross Moat: It also remains the case that recurrent pericarditis patients are, you know, broadly dispersed across the country. We have to touch, you know, many touch points across the country in order to educate physicians. We focus on peer-to-peer education to do that as well as, of course, our sales team and the digital marketing initiatives such as the new DTC campaign, which we're excited about.

Speaker #6: But it also remains the case that recurrent pericarditis patients are broadly dispersed across the country. We have to touch many touch points across the country in order to educate physicians.

Speaker #6: We focus on peer-to-peer education to do that as well as, of course, our sales team. And the digital marketing initiatives such as the new DTC campaign, which we're excited about.

Ross Moat: As I mentioned earlier, you know, with only around 14% of patients that suffer recurrent pericarditis having an unaided awareness of ARCALYST, clearly putting the power in the hands of the patient and the knowledge in the hands of the patient of their disease, acknowledging that, you know, many patients go through multiple physicians and, you know, multiple misdiagnoses before they get the recurrent pericarditis diagnosis, we think can play a substantial role in helping the awareness and empowering patients to go and ask their physicians about recurrent pericarditis, about ARCALYST, and ultimately, could play, you know, one of the roles amongst many things that we're doing in continuing to seize the opportunity that we have ahead.

Speaker #6: But as I mentioned earlier, with only around 14% of patients that suffer recurrent pericarditis having an unaided awareness of our clients, clearly putting the power in the hands of the patient and the knowledge in the hands of the patient of their disease is important, acknowledging that many patients go through multiple physicians and multiple misdiagnoses before they get the recurrent pericarditis diagnosis.

Speaker #6: We think can play a substantial role in helping the awareness and empowering patients to go and ask their physicians about recurrent pericarditis, about our clients, and ultimately could play one of the roles amongst many things that we're doing in continuing to seize the opportunity that we have ahead.

Edward Nash: That's very helpful. Thank you.

Speaker #4: It's very helpful. Thank you.

Ross Moat: Thank you.

Operator: One moment for our next question. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Speaker #6: Thank you.

Speaker #4: One moment before our next question. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi: Hi. Thank you. Good morning, and congratulations on the strong quarterly results. I was wondering first if you could maybe elaborate a little bit more on the co-payment commentary for the quarter. Is this gonna be something just specific to this particular quarter, or could it be more potentially structurally favorable to gross-to-nets over the long term? My second question is on KPL-387. Just with regard to the transition, the switch study that's ongoing, can you comment if the implication here is that you have a fairly confident view on the dose going forward for the Phase 3, or are you still testing multiple doses there? Thank you very much.

Speaker #8: Hi, thank you. Good morning and congratulations on the strong quarterly results. I was wondering first if you could maybe elaborate a little bit more on the copayment commentary for the quarter?

Speaker #8: Is this going to be something just specific to this particular quarter or could it be more potentially structurally favorable to growth to net over the long term?

Speaker #8: And my second question is on KPL-387. Just with regard to the transition, the switch study that's ongoing, can you comment if the implication here is that you have a fairly confident view on the dose going forward for the Phase 3, or are you still testing multiple doses there?

Speaker #8: Thank you very much.

Ross Moat: I-

Mark Ragosa: Can I, may take the first.

Speaker #6: Thanks.

Ross Moat: Yes.

Mark Ragosa: on the gross-to-net.

Speaker #3: We take the first. On the growth to net. So I think, Paul, we haven't provided specific guidance on growth to net. So we still do not expect major fluctuations relative to 2025, but we do anticipate now the copay support will be favorable to growth to net on an annual basis with the majority of the impact having taken place in the first quarter.

Ross Moat: Yep.

Mark Ragosa: I think, Paul, we haven't provided specific guidance on gross-to-net. We still do not expect major fluctuations relative to 2025, but we do anticipate now that copay support will be favorable to gross-to-net on an annual basis, with the majority of the impact having taken place in Q1.

Mark Ragosa: I think as we, you know, sort of take a look at gross-to-net over the course of the year, you know, I'll kind of say what we've said before here, but we do expect to return to our historical pattern where, you know, absent any sort of prior period reserve adjustments, you know, we do expect gross-to-net to be highest in Q1, to work lower in Q2 and Q3, and then begin to shift higher again in Q4 due to industry dynamics as they begin to play a factor again. I don't know if there's components to the copay that you wanna discuss further than that, but at least that's the impact on gross-to-net.

Speaker #3: And I think as we sort of take a look at growth to net over the course of the year, I'll kind of say what we've said before here, but we do expect to return to our historical pattern where absent any sort of prior period reserve adjustments, we do expect growth to net to be highest in the first quarter to work lower in the second and the third quarter and then begin to shift higher again in the fourth quarter due to industry dynamics as they begin to play a factor again.

Speaker #3: I don't know if there are components of the copay that you want to discuss further than that, but at least that's the impact on growth to net.

Ross Moat: Yeah. Mark, I thank you for that. I just maybe add a little bit more flavor onto the copay dynamics, Paul. We did make enhancements to our copay assistance program at the beginning of this year, which ultimately reduced the average copay payment per patient, and subsequently, you know, had the knock-on effect to the more favorable gross-to-net versus Q1 of last year, albeit higher than Q4 of last year. That's driven by a couple of things. Firstly, reducing the maximum of amount of copay payments that we make per patient.

Speaker #6: Yeah, that's why I made Mark thank you for that. I just maybe add a little bit more flavor onto the copay dynamics, Paul. So we did make enhancements to our copay assistance program at the beginning of this year, which ultimately reduced the average copay payment per patient and subsequently had the knock-on effect to the more favorable growth to net versus Q1 of last year, albeit higher than Q4 of last year.

Speaker #6: And that's driven by a couple of things. Firstly, reducing the maximum of amount of copay payments that we make per patient. And secondly, we also implemented a machine learning solution to proactively identify patients who are on non-traditional payment plans such as Maximizer plans in order to kind of pick up those patients which you may know a lot of these plans are designed to take the cost to the manufacturers all the way until funds are exhausted before the insurance company has picked up on it.

Ross Moat: secondly, we also implemented a machine learning solution to proactively identify patients who are on non-traditional payment plans, such as maximizer plans, in order to kinda pick up those patients, which, you know, you may know a lot of these plans are designed to take the cost to the manufacturers all the way until funds are exhausted before the insurance companies pick up on it. By lowering that copay amount for those non-traditional plans, it reduced the maximum amount that we paid per patient, but before the patients got full coverage under their insurer. That had the knock-on effect into the gross-to-net. Thank you for the question, Paul.

Speaker #6: So by lowering that copay amount for those non-traditional plans, it reduced the maximum amount that we paid per patient before the patients got full coverage under their insurer.

Speaker #6: So, that had the knock-on effect into the growth to net. So, thank you for the question, Paul.

John Paolini: Good morning, Paul. Thank you for your question about the transition to monotherapy study. The details of the study design that we've shared so far, can be found in ClinicalTrials.gov. What you will see there is the overall architecture of the study, but the disclosure does not include specific information of the dose level or dose levels that would be studied. We will have more to say at a later date about the design of the study.

Speaker #3: And good morning, Paul. Thank you for your question about the transition to monotherapy study. So the details of the study design that we've shared so far can be found in clinicaltrials.gov.

Speaker #3: And what you will see there is the overall architecture of the study but the disclosure does not include specific information of the dose levels that are being dose level or dose levels that would be studied.

Speaker #3: So we will have more to say at a later date about the design of the study.

Paul Choi: Okay, great. Thank you.

Speaker #4: Okay, great. Thank you. One moment before our next question. Next question comes from Jeff Meacham with Citi. Your line is open.

Operator: One moment for our next question. The next question comes from Geoff Meacham with Citi. Your line is open.

Geoff Meacham: Hey, guys. Good morning. Thanks for the question. Just had two quick ones. Ross, on the commercial side, you know, is there a tipping point for adding more patients to the, to the first recurrent segment? I wasn't sure maybe if you wanted to wait a little bit longer on the awareness and DTC visibility, or do you feel like you have to navigate maybe reimbursement hurdles in that, you know, more, more upstream segment? The second one for Sanj. With the positive cash flow, you got consistent profitability. How do you, how do you think about maximizing value from here? Would you want to be, you know, in the phase 3 for KPL-387 before you take another look at BD? I wasn't sure how you're thinking about it. Thank you.

Speaker #8: Hey, guys. Good morning. Thanks for the question. Just had two quick ones. We're also on the commercial side. Is there a tipping point for adding more patients to the first recurrent segment?

Speaker #8: I wasn't sure maybe if you wanted to wait a little bit longer. On the awareness and DTC visibility, do you feel like you have to navigate maybe reimbursement hurdles in that more upstream segment?

Speaker #8: And then the second one for Sanj, with the positive cash flow, you got consistent profitability. How do you think about maximizing value from here?

Speaker #8: Would you want to be in the phase three for 387 before you take another look at BD? I wasn't sure how you're thinking about it.

Speaker #8: Thank you.

Ross Moat: Thanks very much, Geoff. I appreciate the question. As mentioned earlier, you know, we're around 18% penetrated into the 2+ recurrence group. About 20% of prescriptions that we have, you know, now are in the 1st recurrence group. That's grown over time. We think the 2025 ACC Concise Clinical Guidance is also helpful towards that as it places the use of IL-1 inhibition prior to the use of corticosteroids. Moving ARCALYST further, you know, upstream early on in the disease. We think those things are all important and acknowledging that, you know, ARCALYST really has a very broad label, which is agnostic to the number of flares that a patient has suffered.

Speaker #6: Thanks very much, Jeff. I appreciate the question. So yeah, as mentioned earlier, we were at the last reported, we were around 18% penetrating into the two-plus recurrence group.

Speaker #6: About 20% of prescriptions that we have now are in the first recurrence group. That's grown over time. We think the 2025 ACC concise clinical guidance is also helpful towards that as it places the use of IL-1 inhibition prior to the use of corticosteroids.

Speaker #6: So moving ARC list further, upstream if you like, early on in the disease. So we think those things are all important. And acknowledging that ARC list really has a very broad label, which is agnostic to the number of flares that a patient has suffered.

Ross Moat: We have broad patient coverage really, really across the labeled indication for the majority of plans. We're in a pretty good situation there, which is why we, you know, we feel that the opportunity that we have ahead is still very significant when you take those metrics around the two plus recurrences and the first recurrence group.

Speaker #6: And we have broad patient coverage. Really, really across the labeled indication for the majority of plans. So we're in a pretty good situation there, which is why we feel that the opportunity that we have ahead is still very significant.

Speaker #6: When you take those metrics around the two-plus recurrences and the first recurrence group.

Sanj K. Patel: Geoff, this is Sanj. Thanks for the question as well. As you know, for many years, this team's very much focused on creating value. We also know how to execute. To your point on 387, clearly there's a lot of focus right now on. Getting through this Phase 2 study, you know, how you get through H2 of this year and starting our Phase 3 study this year, I think is very exciting. You know, clearly we're very much focused on capturing further growth with ARCALYST. Very important continued effort for us. As we've said, KPL-1161 also should enter the clinic this year.

Speaker #3: Jeff, this is Ans. Thanks for the question as well. As you know, for many years, this team's very much focused on creating value. And we also now have to execute.

Speaker #3: So to your point on 387, it is a lot of focus right now on getting through this phase two study, having taken the second half of the share, and starting at phase three study this year that I think is very exciting.

Sanj K. Patel: Getting through this Phase 2 study, you know, how you get through H2 of this year and starting our Phase 3 study this year, I think is very exciting. You know, clearly we're very much focused on capturing further growth with ARCALYST. Very important continued effort for us. As we've said, KPL-1161 also should enter the clinic this year. A number of milestones for us. You know, we balance all that consistently looking at how there are other ways to create value. As you said, we constantly look at BD opportunities. We have a very high bar, though. You know, we try to stay as pragmatic as possible, looking at all the value both internal creations with, you know, via creation from internal value drivers, but also looking at business development.

Speaker #3: Clearly, we're very much focused on capturing further growth of ARC list. It's very important. Continued effort for us. But then, as we've said one more time, it's one also should enter the clinic this year.

Sanj K. Patel: A number of milestones for us. You know, we balance all that consistently looking at how there are other ways to create value. As you said, we constantly look at BD opportunities. We have a very high bar, though. You know, we try to stay as pragmatic as possible, looking at all the value both internal creations with, you know, via creation from internal value drivers, but also looking at business development.

Speaker #3: So a number of milestones for us. We balance all that consistently looking at how there are other ways to create value. And as you said, we consider to look at BD opportunities.

Speaker #3: We have a very, very high bar, though. And so we try to stay pragmatic as possible, looking at all the value both in total created via creation from internal value drivers, but also looking at business development.

Sanj K. Patel: We're going to continue to do that. Capital allocation is very important to us. Being efficient is very important to us. You know, we've done that very nicely, I think, through this digital DTC effort and looking at AI ways to really do it very efficiently. Trust us when we say that we'll continue to think about value creation over time and balance it well going forward.

Speaker #3: So we'll continue to do that. But capital allocation is very important to us, being efficient is very important to us. We've done that very nicely.

Speaker #3: I think through this digital DTC effort and looking at AI ways to really do it very efficiently. So trust us when we say that we'll continue to think about value creation all the time.

Speaker #3: And balance it well going forward.

Geoff Meacham: Okay. Thank you.

Speaker #4: Okay. Thank you. One moment before our next question. Our next question comes from Roger Song with Jefferies. Your line is open.

Operator: One moment for our next question. Our next question comes from Roger Song with Jefferies. Your line is open.

[Analyst] (Jefferies): Hi, good morning, team. This is Fiona on for Roger. Congrats on the strong quarter, thanks for taking our question. Maybe just a quick one on KPL-387. Any meaningful difference in terms of formulation versus ARCALYST, do you plan to use auto-injector? Maybe just down the line, if 387 gets approved, how do you plan your commercial strategy around incorporating to potentially transitioning to 387? Thank you.

Speaker #5: Hi, good morning, team. This is Fiona off of Roger. Congrats on the strong quarter and thanks for taking our questions. Maybe just a quick one on KPL-387.

Speaker #5: Any meaningful difference in terms of formulation versus the ARC list? And do you plan to use an auto-injector? And maybe just down the line, if 387 gets improved, how do you plan your commercial strategy around incorporating—to potentially transition to—387?

Speaker #5: Thank you.

John Paolini: Yes. No, thanks for that question. I'll handle some of the biophysical characteristics of the molecules to maybe lay a little bit of groundwork and then turn it over to Sanj with regard to next steps. Yeah, there is a difference with regard to KPL-387 in that it is a liquid formulation. That liquid formulation, you know, allows for the total dose, if you will, of KPL-387 to be delivered in a single syringe subcutaneously. We anticipate that with the extended pharmacokinetics, which we've shown previously in Phase 1, that that would support once-monthly dosing. Once you have that profile, it then does set up a situation, if you will, that is quite favorable for the development of an auto-injector.

Speaker #3: Yeah. So thanks for that question. I'll handle some of the biophysical characteristics of the molecules to maybe lay a little bit of groundwork. And then turn it over to Sanj with regard to next steps.

Speaker #3: So yeah, there is a difference with regard to KPL 387 in that it is a liquid formulation. And so that liquid formulation allows for the total dose, if you will, of KPL 387 to be delivered in a single syringe subcutaneously.

Speaker #3: And we anticipate that with the extended pharmacokinetics, which we've shown previously in phase one, that that would support once monthly dosing. And so once you have that profile it then does set up a situation, if you will, that is quite favorable for the development of an auto-injector.

John Paolini: We have not discussed that in detail at this time. I'll turn it over to Sanj.

Speaker #3: And we have not discussed that in detail at this time. But I'll turn it over to Sanj.

Sanj K. Patel: Yeah. Fiona, nothing really to add. Obviously, we'll continue to execute on the ongoing clinical trials. We talked about those today, phase two, phase three study. Starting the phase three this year, obviously entering more One Six One. Nothing else to add other than that we plan to do them as fast as humanly possible and as well as humanly possible.

Speaker #2: Yeah, and Fiona, nothing really to add. Obviously, we'll continue to execute on the ongoing clinical trials. We talked about those today—phase 2, phase 3 study—starting at phase 3 this year.

Speaker #2: Obviously, entering more once it's one. But nothing else to add other than that we plan to do them as fast as humanly possible. And as well as humanly possible.

Operator: Thank you. One moment for our next question. Our next question comes from Eva Fortea with Wells Fargo. Your line is open.

Speaker #4: Thank you. One moment before our next question. Our next question comes from Eva Fortier with Wells Fargo. Your line is open.

Eva Fortea: Hey, good morning. Congrats on the quarter, and thanks for taking our questions. 2 quick ones from us. First, how should we be thinking about R&D expense for the rest of the year and into 2027 as KPL-387 phase 3 and KPL-1161 phase 1 are initiated? The second question is, you've guided to initiating the phase 3 pivotal portion for KPL-387 by year-end 2026. Are there any key steps or milestones you need to clear to initiate the study, or is it just a matter of seeing the phase 2 data before moving forward? Thanks.

Speaker #5: Hey, good morning. Congrats on the quarter and thanks for taking our questions. Two quick ones from us. First, how should we be thinking about R&D expense for the rest of the year and into 2027 as 387 phase three and 1161 phase one are initiated?

Speaker #5: And the second question is you've guided to initiating the phase three pivotal portion for 387 by year-end '26. Are there any key steps or milestones you need to clear to initiate the study, or is it just a matter of seeing the phase two data before moving forward?

Speaker #5: Thanks.

Mark Ragosa: Thanks, Eva, for the question. Maybe just to touch upon the R&D question first here. You know, similarly to an earlier question, we haven't provided explicit guidance. You know, but that being said, you know, I think on a percentage of sales basis, R&D has been fairly consistent over the last year. Really with R&D, it's timing of our clinical trials and manufacturing of clinical supply that are the key variables. We've disclosed several ongoing investments that we plan to further advance in 2026, including the development of KPL-387 into phase 3 and KPL-1161 into phase 1.

Speaker #3: Thanks, Eva, for the question. Maybe just to touch upon the R&D question first here. Similarly to an earlier question, we haven't provided explicit guidance.

Speaker #3: But that being said, I think on a percentage of sales basis, R&D has been fairly consistent over the last year. And really, with R&D, it's timing of our clinical trials and manufacturing of clinical supply that are the key variables.

Speaker #3: And so we've disclosed several ongoing investments that we plan to further advance in 2026, including the development of 387 into phase three. And KPL 1161 into phase one.

Mark Ragosa: You know, obviously the longer trials go on, they tend to get a little bit more expensive, but I think keeping in the context of where sales growth has been, and where we've been fairly consistent on R&D to sales over the last year is an important metric to keep in mind.

Speaker #3: And so, obviously, the longer trials go on, they tend to get a little bit more expensive. But I think keeping in the context of where sales growth has been and where we've been fairly consistent on R&D to sales over the last year is an important metric to keep in mind.

John Paolini: Eva, thank you for your question, with regard to the phase two, three transition. With phase two data expected in the H2 of 2026, we're on track for receiving dose level confirmation data, you know, in that time framework. Because the phase two dose focusing portion and the phase three pivotal portion have been integrated into a single phase two, three protocol, the phase three pivotal trial can begin independently of phase two execution.

Speaker #6: And then, Eva, thank you for your question. With regard to the phase two, three transition. So with phase two data expected in the second half of 2026, we're on track for receiving dose-level confirmation data in that time framework.

Speaker #6: And because the phase two dose focusing portion and the phase three pivotal portion have been integrated into a single phase two, three protocol, the phase three pivotal trial can begin independently of phase two execution.

Eva Fortea: Got it. Thanks.

Speaker #5: Got it. Thanks.

Operator: I'm not showing any further questions at this time. I turn the call back over to Sanj for any further remarks.

Speaker #4: And I'm not showing any further questions at this time. I turn the call back over to Sanj for any further remarks.

Sanj K. Patel: Thanks, operator. Thank you for all the questions and joining the call today. We look forward to the remainder of the year and of course providing additional updates in the future. Thank you. It is great.

Speaker #2: Thanks, operators. And thank you for all the questions and joining the call today. We look forward to the remainder of the year. And of course, providing additional updates in the future.

Speaker #2: Thank you. It's quite fine.

Operator: Thank you. Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect and have a wonderful day.

Speaker #4: Thank you, ladies and gentlemen. This does conclude today's presentation. We thank you for your participation. You may now disconnect and have a wonderful day.

Q1 2026 Kiniksa Pharmaceuticals International PLC Earnings Call

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