Kiniksa Pharmaceuticals International PLC (KNSA) 2025 Q4 法說會逐字稿

Thank you for standing by. Welcome to the Kiniksa Pharmaceuticals fourth-quarter and full-year 2025 earnings conference call. (Operator Instructions) As a reminder, today's program is being recorded.

感謝您的耐心等待。歡迎參加 Kiniksa Pharmaceuticals 2025 年第四季及全年業績電話會議。（操作說明）提醒各位，今天的節目正在錄製中。

And now I'd like to introduce your host for today's program, Jonathan Kirshenbaum, Investor Relations. Please go ahead, sir.

現在，我謹向大家介紹今天節目的主持人，投資者關係部的喬納森·柯申鮑姆。請繼續，先生。

Thank you, operator. Good morning, everyone, and thank you for joining Kiniksa's call to discuss our fourth-quarter and full-year 2025 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investors section.

謝謝接線生。各位早安，感謝各位參加 Kiniksa 的電話會議，討論我們 2025 年第四季度和全年財務業績以及最近的投資組合執行情況。有關這些結果的新聞稿可在我們網站的「投資者」欄位下找到。

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 discuss our IL-1 inhibition franchise and provide an update on ARCALYST commercial execution.

至於議程，我們的執行長桑吉·K·帕特爾將首先作介紹。接下來，我們的營運長羅斯·莫特將討論我們的 IL-1 抑制劑產品線，並提供 ARCALYST 商業執行的最新資訊。

Then, Kiniksa's Chief Financial Officer, Mark Ragosa, will review our fourth-quarter and full-year 2025 financial results. And finally, Sanj will share closing remarks and kick off the Q&A session, for which Dr. John Paolini, our Chief Medical Officer; and Eben Tessari, our Chief Strategy Officer, will also be on the line.

然後，Kiniksa 的財務長 Mark Ragosa 將審查我們 2025 年第四季和全年的財務表現。最後，Sanj 將發表閉幕致詞並開始問答環節，我們的首席醫療官 John Paolini 博士和首席策略官 Eben Tessari 也將在線上參與問答。

Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. A review of such statements and risk factors can be found on this slide, as well as under the caption Risk Factors contained in our SEC filings. These statements speak only as the date of this presentation, and we undertake no obligation to update such statements, except as required by law.

在開始之前，請注意，我們今天將做出一些前瞻性陳述，這些陳述存在風險和不確定性，可能導致實際結果與這些陳述有重大差異。您可以在本投影片中找到這些聲明和風險因素的審查，也可以在我們的美國證券交易委員會文件中「風險因素」標題下找到。這些聲明僅代表本次發布之日的情況，除法律要求外，我們不承擔更新這些聲明的義務。

With that, I'll turn it over to Sanj.

這樣，我就把麥克風交給桑吉了。

Thanks, Jonathan, and good morning or good afternoon, everyone. I look forward today to reviewing Kiniksa's fourth quarter performance and key highlights across our portfolio over the past year. Diligent execution across our commercial and clinical organization throughout 2025 has put us in a strong position to further advance our business.

謝謝你，喬納森，大家早安/下午好。我期待今天回顧 Kiniksa 第四季的業績以及過去一年我們投資組合中的主要亮點。2025 年，我們商業和臨床部門的辛勤執行使我們處於有利地位，可以進一步推進我們的業務發展。

ARCALYST revenue continues to grow, driven by the expanding adoption of IL-1 alpha and beta inhibition across the recurrent pericarditis population. Since the launch in 2021, we have delivered this transformative therapy to thousands of patients, enabling a fundamental shift in the treatment paradigm and driving sustained revenue growth.

受復發性心包膜炎患者族群中 IL-1 α 和 β 抑制劑日益普及的推動，ARCALYST 的收入持續成長。自 2021 年推出以來，我們已為數千名患者提供了這種變革性療法，從而從根本上改變了治療模式，並推動了持續的收入成長。

On a year-over-year basis, ARCALYST product revenue grew 65% to $202.1 million in the fourth quarter and 62% to $677.6 million for the full year 2025. Importantly, ARCALYST revenue growth has been profitable since the fourth quarter of 2021. This has allowed us to make strategic investments across sales and marketing with the aim of capturing additional long-term growth. Ross will cover this in a moment.

與去年同期相比，ARCALYST 產品營收在第四季成長了 65%，達到 2.021 億美元，2025 年全年成長了 62%，達到 6.776 億美元。重要的是，自 2021 年第四季以來，ARCALYST 的營收成長一直獲利。這使我們能夠在銷售和行銷方面進行策略性投資，以實現更多的長期成長。羅斯稍後會談到這一點。

Kiniksa's robust financial position gives us the ability to create additional value by investing in R&D and advancing internally discovered and developed assets such as KPL-387 and KPL-1161 as well as pursuing strategic business development.

Kiniksa 穩健的財務狀況使我們能夠透過投資研發和推進內部發現和開發的資產（如 KPL-387 和 KPL-1161）以及進行策略性業務發展來創造更多價值。

Focusing on clinical, this time last year, we announced our development program for KPL-387 in recurrent pericarditis with plans to initiate a Phase 2, Phase 3 clinical trial in the middle of last year. That was achieved, and we are continuing to enroll and dose patients in the Phase 2 portion of that program, and we are on track for data in the second half of this year.

去年這個時候，我們專注於臨床方面，宣布了針對複發性心包膜炎的 KPL-387 的開發計劃，並計劃在去年年中啟動 2 期和 3 期臨床試驗。目標已經實現，我們正在繼續招募和給該計畫第二階段的患者用藥，並且我們預計在今年下半年獲得數據。

Together with continuing ARCALYST growth, the development of KPL-387 positions Kiniksa to extend its leadership of the recurrent pericarditis market. In particular, we believe KPL-387 could address key patient needs and expand penetration into the addressable market by potentially enabling monthly dosing with an auto-injector.

隨著 ARCALYST 的持續成長，KPL-387 的開發使 Kiniksa 能夠擴大其在復發性心包膜炎市場的領先地位。我們認為，KPL-387 尤其能夠滿足關鍵的患者需求，並透過可能實現使用自動注射器進行每月給藥，從而擴大其在目標市場的滲透率。

In addition to KPL-387, we also recently announced that we plan to be in the clinic with KPL-1161, which is our Fc-modified IL-1 alpha and beta inhibitor by the end of this year. As highlighted, we made important progress across our commercial and clinical portfolio in 2025, and we are working diligently, some would say like the clappers, to continue that strong trajectory in the year ahead.

除了 KPL-387 之外，我們最近還宣布，我們計劃在今年年底前將 KPL-1161（一種 Fc 修飾的 IL-1 α 和 β 抑制劑）投入臨床試驗。正如之前所強調的，我們在 2025 年的商業和臨床產品組合方面取得了重要進展，我們正在努力工作，有些人甚至會說我們像拍手一樣拼命，以期在未來一年繼續保持這一強勁勢頭。

And with that, I'll turn it over to Ross to review our commercial execution.

接下來，我將把發言權交給羅斯，讓他來審核我們的商業執行。

Thank you, Sanj. As we shared earlier this year, Kiniksa's robust execution over the first five years of our commercialization has established the recurrent pericarditis market and put ARCALYST on a path to future blockbuster status. Our full year 2025 net revenue was $677.6 million, which is an increase of more than $260 million compared to 2024 and represents the highest year-on-year growth to date.

謝謝你，桑吉。正如我們今年稍早分享的那樣，Kiniksa 在商業化的前五年中取得了強勁的執行力，確立了復發性心包膜炎市場，並使 ARCALYST 走上了未來成為重磅藥物的道路。我們 2025 年全年淨收入為 6.776 億美元，比 2024 年增加了 2.6 億美元以上，是迄今為止最高的年成長率。

The primary driver of this growth has been the expanding adoption of interleukin-1 alpha and beta inhibition with ARCALYST as a second-line treatment immediately after the failure of NSAIDs and colchicine. In 2026, we expect to continue expanding the utilization of ARCALYST in recurrent pericarditis and reiterate our previously announced full year net revenue guidance of between $900 million and $920 million.

推動這一增長的主要因素是白細胞介素-1α和β抑制劑的廣泛應用，ARCALYST 可作為非類固醇抗發炎藥和秋水仙鹼治療失敗後的二線療法。2026 年，我們預計將繼續擴大 ARCALYST 在復發性心包膜炎的應用，並重申我們先前宣布的全年淨收入預期，即 9 億美元至 9.2 億美元。

Historically, Q1 faces some seasonal headwinds in the specialty drug sector associated with payer plan changes and co-pay resets. And as a reminder, in Q1 of last year, we benefited from a onetime bolus of patients who transitioned to commercial therapy associated with the IRA and Medicare Part D changes.

從歷史上看，第一季專業藥品產業會面臨一些季節性不利因素，例如支付方計畫的變化和共同支付額的重置。提醒一下，去年第一季度，由於 IRA 和 Medicare Part D 的變化，我們受益於一次性患者激增，這些患者轉而接受商業治療。

As you've heard from Sanj, our ARCALYST franchise is profitable, which, over time, has allowed us to invest in our commercial infrastructure and digital marketing efforts to maximize our opportunity in recurrent pericarditis by reaching additional health care professionals and patients.

正如你從 Sanj 那裡聽到的，我們的 ARCALYST 特許經營店盈利頗豐，隨著時間的推移，這使我們能夠投資於我們的商業基礎設施和數位行銷工作，透過接觸更多的醫療保健專業人員和患者，最大限度地提高我們在復發性心包炎領域的機會。

In 2026, our focus is to unlock the next phase of growth for ARCALYST by driving further physician awareness of the 2025 ACC Concise Clinical Guidance, advancing our digital marketing initiatives to empower patients to discuss ARCALYST with their physician, as well as utilizing AI and machine learning to efficiently and effectively target the right physicians at the right point in time, and to explore ways to expand the impact of pericardial disease centers where the growth in ARCALYST prescriptions has outpaced growth at other sites.

2026 年，我們的重點是推動 ARCALYST 進入下一個增長階段，具體措施包括：進一步提高醫生對 2025 年 ACC 簡明臨床指南的認識；推進我們的數位行銷計劃，使患者能夠與醫生討論 ARCALYST；利用人工智慧和機器學習技術，在合適的時間高效地找到合適的醫生；以及探索其他方法的影響中心的影響。

At the end of 2025, more than 4,150 prescribers had written a prescription for ARCALYST. Of those, around 29% or more than 1,200 prescribers have written ARCALYST for two or more recurrent pericarditis patients. This continued growth in both total and repeat prescribers illustrates how we are evolving the treatment paradigm in recurrent pericarditis by updating the approach for treating the disease with targeted interleukin-1 pathway inhibition.

截至 2025 年底，已有超過 4,150 名處方醫生開立了 ARCALYST 的處方。其中，約 29%（超過 1200 名）處方醫生為兩名或兩名以上復發性心包膜炎患者開立了 ARCALYST 處方。總處方量和重複處方量持續增長，顯示我們正在透過更新治療復發性心包膜炎的方法（即靶向抑制白細胞介素-1通路）來改進治療模式。

Additionally, we've built a strong foundation to our commercialization with the average total duration of therapy approaching three years, robust payer approval rates, and strong patient adherence, all of which has created solid commercial fundamentals. With increasing penetration into the multiple recurrence target market and additional upside with ARCALYST being used earlier in the disease course, we continue to see meaningful opportunity ahead.

此外，我們為商業化奠定了堅實的基礎，平均總療程接近三年，支付方批准率高，患者依從性強，所有這些都創造了穩固的商業基礎。隨著 ARCALYST 在多發性復發目標市場的滲透率不斷提高，以及在疾病早期階段使用 ARCALYST 帶來的額外成長潛力，我們繼續看到未來存在著重要的機會。

The combination of an effective commercial engine with robust safety and efficacy data for ARCALYST means we are well positioned to continue expanding our reach into both the multiple recurrence and first recurrence populations.

ARCALYST 擁有高效的商業引擎和可靠的安全性和有效性數據，這意味著我們有能力繼續擴大其在多次復發和首次復發人群中的應用範圍。

On the left-hand side of this slide, you can see that our penetration into the 2-plus recurrence target market has increased over time, most recently up to approximately 18% at the end of 2025 compared to around 15% in the middle of last year and 13% at the end of 2024.

從這張投影片的左側可以看出，我們對 2 次以上復購目標市場的滲透率隨著時間的推移而增加，最近在 2025 年底達到了約 18%，而去年年中約為 15%，2024 年底約為 13%。

As we've previously stated, approximately 20% of ARCALYST prescriptions have been written for patients following their first recurrence, demonstrated increased use earlier in the disease course. Overall, we are seeing physicians more readily turn to targeted interleukin-1 alpha and beta inhibition with ARCALYST after the failure of NSAIDs and colchicine.

正如我們之前所述，大約 20% 的 ARCALYST 處方是在患者首次復發後開出的，這表明在疾病早期階段使用量有所增加。總的來說，我們看到，在非類固醇抗發炎藥物和秋水仙鹼治療失敗後，醫生更傾向於使用 ARCALYST 來標靶抑制白血球介素-1α 和 β。

In 2025, this evolution in treatment paradigm was ratified by the publication of the ACC Concise Clinical Guidance, which now recommends interleukin-1 pathway inhibition as a second-line approach immediately following the failure of NSAIDs and colchicine in patients suffering from recurrent pericarditis.

2025 年，ACC 發布的《簡明臨床指南》證實了治療模式的這種演變，該指南現在建議，對於患有復發性心包炎的患者，在 NSAIDs 和秋水仙鹼治療失敗後，應立即採用白細胞介素-1 通路抑製劑作為二線治療方法。

As you've heard, we are pleased with our solid execution and progress. But far more importantly, we are excited about the opportunity ahead to support significantly more recurrent pericarditis patients with ARCALYST.

正如你們所聽到的，我們對我們紮實的執行力和所取得的進展感到滿意。但更重要的是，我們對未來有機會透過 ARCALYST 為更多復發性心包膜炎患者提供支持感到興奮。

And with that, I'll turn the call over to Mark to review our financial results.

接下來，我將把電話交給馬克，讓他來回顧我們的財務表現。

Thanks, Ross. In 2025, we advanced both our commercial business and our clinical portfolio while maintaining a strong balance sheet, positioning us to continue to help patients and grow in 2026 and beyond. This morning, I will walk through our fourth quarter and full year 2025 financial results. You can find our detailed financial information in today's press release.

謝謝你，羅斯。2025年，我們在維持強勁資產負債表的同時，推進了商業業務和臨床產品組合的發展，這使我們能夠繼續幫助患者，並在2026年及以後實現成長。今天上午，我將詳細介紹我們2025年第四季和全年的財務表現。您可以在今天的新聞稿中找到我們詳細的財務資訊。

There are a few items of note. First, starting on the left-hand side of this slide with our income statement. As Sanj and Ross noted, broader adoption of IL-1 alpha and IL-1 beta inhibition as a second-line treatment drove strong ARCALYST product revenue growth in 2025. ARCALYST product revenue grew 65% year over year to $202.1 million in the fourth quarter and 62% to $677.6 million for the full year 2025.

有幾點要注意。首先，從這張投影片的左邊開始，來看我們的損益表。正如 Sanj 和 Ross 指出的那樣，IL-1 α 和 IL-1 β 抑制劑作為二線治療的更廣泛採用推動了 ARCALYST 產品在 2025 年的強勁收入成長。ARCALYST 產品營收在第四季年增 65% 至 2.021 億美元，2025 年全年年增 62% 至 6.776 億美元。

Second, operating expenses grew year over year in both the fourth quarter and the full year 2025, driven by higher cost of goods sold due to ARCALYST growth, increased collaboration expenses aligned with higher ARCALYST collaboration profit, and additional SG&A expense with investment to further support ARCALYST commercialization.

其次，由於 ARCALYST 的成長導致銷售成本增加、與 ARCALYST 合作利潤增加相關的合作費用增加，以及為進一步支持 ARCALYST 商業化而進行的投資帶來的額外銷售、管理及行政費用，2025 年第四季度和全年營運費用均同比增長。

Third, net income was $14.2 million in the fourth quarter of 2025 compared to a net loss of $8.9 million in the fourth quarter of 2024. And net income was $59 million for the full year 2025 compared to a net loss of $43.2 million for the full year 2024.

第三，2025 年第四季淨收入為 1,420 萬美元，而 2024 年第四季淨虧損為 890 萬美元。2025 年全年淨收入為 5,900 萬美元，而 2024 年全年淨虧損為 4,320 萬美元。

Fourth, the right-hand side of the slide provides the calculation for ARCALYST collaboration profit, which largely drives total collaboration expenses. On a year-over-year basis, ARCALYST collaboration profit grew faster than sales, up 83% to $140 million in the fourth quarter and up 96% to $459 million for the full year 2025.

第四，投影片的右側提供了 ARCALYST 合作利潤的計算方法，這在很大程度上決定了合作總支出。與去年同期相比，ARCALYST 合作專案的利潤成長速度超過了銷售額的成長速度，第四季成長 83% 至 1.4 億美元，2025 年全年成長 96% 至 4.59 億美元。

Lastly, regarding our balance sheet at the bottom of the slide, we ended 2025 with $414.1 million in cash, representing $170.4 million of net cash generation for the year, and we expect to remain cash flow positive on an annual basis under our current operating plan.

最後，關於幻燈片底部的資產負債表，截至 2025 年底，我們擁有 4.141 億美元的現金，相當於當年淨現金流入 1.704 億美元，我們預計在目前的營運計劃下，每年都能保持正現金流。

With that, I'll turn the call back to Sanj for closing remarks.

接下來，我將把電話轉回桑吉，請他作總結發言。

Thanks, Mark. As you've heard, Kiniksa continues to execute both commercially and clinically and is well positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. We've got a brilliant team that is 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.

謝謝你，馬克。正如您所聽到的，Kiniksa 在商業和臨床方面持續取得進展，並且隨著我們 IL-1 α 和 β 抑制劑產品線的增長，我們已做好充分準備，創造巨大的未來價值。我們擁有一支傑出的團隊，致力於透過 ARCALYST 幫助盡可能多的患者，並推進我們臨床產品組合的開發，以便為患有衰弱性疾病的患者帶來更多療法。

With that, happy to turn it back to the operator for questions.

這樣，我就很樂意把電話轉回給操作員，解答他們的問題。

(Operator Instructions) Nick Lorusso, TD Cowen.

（操作說明）Nick Lorusso，TD Cowen。

Hey, guys. Good morning. Thanks very much for taking my question. So you guys have reported continuing increased penetration in the multiple recurrent setting. So I'm wondering what do you think the peak penetration is for ARCALYST in this setting? And how could that evolve with the potential approval of KPL-387? Thanks.

嘿，夥計們。早安.非常感謝您回答我的問題。你們報告稱，在多次復發的情況下，感染率持續上升。所以我想知道你認為在這種情況下 ARCALYST 的峰值穿透力是多少？如果 KPL-387 獲得批准，情況又會如何發展？謝謝。

Thanks, Nick. Maybe I'll start. This is Sanj Patel. I'm happy to pass over to the team or Ross, Nick for the comments. So at this point, we have not commented on the peak penetration. Suffice to say that as I think Ross mentioned, we do believe there's still an awful lot of growth that we can capture with ARCALYST.

謝謝你，尼克。或許我會開始。這是桑吉·帕特爾。我很樂意把麥克風交給團隊成員或羅斯、尼克，請他們發表評論。所以目前為止，我們還沒有對滲透率高峰發表評論。正如羅斯提到的那樣，我們相信 ARCALYST 還有很大的成長空間。

And obviously, a lot of the work that we're doing both through our sales force, through marketing, digital efforts are making a lot of inroads there. So we continue to crack on penetrating into that market. How far it will go, time will tell, but it really is an axis of how much work we put into it and how smart we work.

顯然，我們透過銷售團隊、行銷和數位化努力所做的許多工作都取得了很大進展。因此，我們將繼續努力打入這個市場。它能走多遠，時間會證明一切，但這確實取決於我們投入了多少精力以及我們工作的方式是否聰明。

Ross, any comments?

羅斯，你有什麼要補充的嗎？

No, I think that's great. I mean maybe just to add that we feel like we're relatively nascent in the opportunity. We've got a huge opportunity left ahead. We announced we're around 18% penetrated into the target population of patients with two or more recurrences. That's a 14,000 population at the end of 2025.

不，我覺得這很棒。我的意思是，或許還要補充一點，我們覺得自己在這個領域還處於起步階段。我們面前還有巨大的機會。我們宣布，我們已滲透到目標族群（復發兩次或兩次以上患者）的約 18%。到 2025 年底，人口將達到 14,000 人。

And that's without taking into account those patients that are earlier on in the disease on their first recurrence, which is a much larger group of patients, around 26,000 patients in any given year. So the opportunity is there for us to do much more, albeit that we're happy with where we are at this stage, but we're very excited about the future.

而且這還不包括那些在疾病早期復發的患者，這部分患者群體要大得多，每年約有 26,000 名患者。所以，我們還有很多機會去做更多的事情，儘管我們對目前的狀況感到滿意，但我們對未來充滿期待。

Thanks very much. Appreciate it.

非常感謝。謝謝。

Eva Fortea, Wells Fargo

伊娃福特亞，富國銀行

Good morning. Thanks for taking our questions and congrats on the quarter. A quick one from us. You've mentioned several times now that 20% of ARCALYST patients are in first recurrence versus 80% in 2-plus. And I guess my question is, is the pace of growth in these two different patient populations the same in terms of like ARCALYST? And does your market research suggest potential changes to the 20:80 ratio? Thanks.

早安.感謝您回答我們的問題，並祝賀您本季取得佳績。讓我們來快速分享一下。您已經多次提到，ARCALYST 患者中有 20% 處於首次復發期，而 80% 處於第二次及以上復發期。我想問的是，就 ARCALYST 而言，這兩個不同患者族群的成長速度是否相同？你們的市場調查是否顯示 20:80 的比例可能需要調整？謝謝。

Thanks, Eva. This is Ross. So I'll start to answer that. And John, if you've got anything to add, please feel free to do so. But you're right in stating that the percentage of patients that we have in the first recurrence has grown over time. It's around 20% of all ARCALYST prescriptions that seem to be in the first recurrence group at this stage.

謝謝你，伊娃。這是羅斯。那我就開始回答這個問題。約翰，如果你還有什麼要補充的，請隨時提出。但您說得對，隨著時間的推移，首次復發患者的比例確實有所增加。大約 20% 的 ARCALYST 處方似乎在現階段屬於首次復發組。

So we view that as a positive change as we've evolved the treatment paradigm and as physicians get more and more comfortable both with prescribing ARCALYST but also seeing the effect of having their patients on ARCALYST and what that does to them over the long term for dealing with this multiyear chronic disease in most patients.

因此，我們認為這是一個積極的改變，因為我們改進了治療模式，醫生也越來越習慣於開立 ARCALYST 處方，並且看到了患者服用 ARCALYST 的效果，以及這種藥物對大多數患者長期應對這種多年慢性疾病的作用。

That creates familiarity and confidence to go and prescribe earlier on in the disease and help more patients. So we think that's great. How that will evolve over time is to be seen. But we think it's a positive stage for where we are right now.

這樣可以建立對疾病的熟悉度和信心，使醫生能夠在疾病早期就開立處方，從而幫助更多的患者。所以我們認為這很棒。隨著時間的推移，這種情況將如何演變，還有待觀察。但我們認為，就我們目前的處境而言，這是一個積極的階段。

When we think about those patients in the first recurrence group, there are certainly patients there that are more high risk for longer duration of disease and suffering future recurrences, particularly those patients that have other risk factors or they're suffering from a significant effusion or even cardiac tamponade or constriction and that those patients could be helped within label for ARCALYST, which obviously covers recurrent pericarditis overall and is not -- is agnostic to the number of flares a patient has suffered.

當我們考慮第一組復發患者時，其中肯定有一些患者病情持續時間更長，未來復發的風險更高，特別是那些有其他風險因素或患有嚴重積液甚至心臟壓塞或收縮的患者，這些患者可以在 ARCALYST 的適應症範圍內得到幫助，ARCALYST 顯然涵蓋了所有復發性心包炎，並且不考慮患者經歷過多少次發作。

So the opportunity to help those patients as well and to avoid them going on and suffering future detrimental effects of this disease is very much there for the health care professionals to decide to prescribe within that population. So we're happy that more and more people so far seem to be doing that.

因此，醫護人員完全有機會幫助這些患者，避免他們繼續遭受這種疾病帶來的未來不利影響，並決定是否在該族群中開立處方。所以我們很高興看到越來越多的人似乎都在這樣做。

Got it. Thanks.

知道了。謝謝。

Geoff Meacham, Citi.

傑夫‧米查姆，花旗銀行。

Great. Morning, guys. Congrats on the quarter and thanks for taking the question. Just have a couple. The first on the pipeline, so 387 or even 1161, what's the extent of FDA interactions of late? It does seem that the agency is maybe more open for novelty on design or maybe adding analytics just to speed up the development and maybe down the road, the review process. Just curious your thoughts on that and maybe how you could take advantage of that.

偉大的。早上好，各位。恭喜你本季取得好成績，謝謝你回答這個問題。就吃幾個吧。第一個進入研發階段的藥物，無論是 387 號或 1161 號，最近 FDA 的互動程度如何？該機構似乎對設計上的創新持更開放的態度，或者可能添加分析功能來加快開發速度，並可能在未來加快審查過程。我只是好奇你對此有何看法，以及你如何能利用這一點。

And the second one, another one on first recurrence versus second or later. Are there differences in persistent rates between those two populations? I wasn't sure how any commercial metrics tease out between those two populations. Thank you.

第二個問題是，第一次復發與第二次或之後復發相比如何。這兩個人群的持續感染率是否有差異？我不確定任何商業指標如何區分這兩個群體。謝謝。

Yeah. Good to hear your voice, Geoff. Thank you for the question. Maybe I'll take a quick start and then John, pass over to you for the remainder of the interaction with the FDA, and then Ross for you on the recurrences. So as always, we approach our development plans with absolute rigor no matter what we see in the agency. And I think a lot -- it's not lost on us that there have been some changes.

是的。很高興聽到你的聲音，傑夫。謝謝你的提問。也許我會先快速開始，然後約翰，把剩下的與 FDA 的溝通工作交給你，然後羅斯，把復發問題交給你。所以，無論我們在公司內部看到什麼，我們都會一如既往地以絕對的嚴謹態度對待我們的發展計畫。而且我認為很多人都意識到——我們並沒有忽視已經發生了一些變化。

But I think in the history of Kiniksa and even before, we've always took great pride in having a lot of thought, diligence, quality and putting really robust development packages together. That changes no matter what. But you're obviously right, we are quite excited about the new development of 387 and 1161, believe there's a lot of potential there. But I think no matter what John is about to say in terms of interactions with the FDA, we treat it the same, and we put together very robust development packages with well-thought out protocols.

但我認為，在 Kiniksa 的發展歷程中，甚至在此之前，我們一直以深思熟慮、勤奮努力、追求卓越品質以及打造真正強大的開發方案而感到自豪。無論如何，情況都會改變。但您顯然是對的，我們對 387 和 1161 的新發展感到非常興奮，相信它們有很大的潛力。但我認為，無論約翰接下來要就與 FDA 的互動發表什麼言論，我們都會一視同仁地對待，並製定出非常完善的開發方案和深思熟慮的規程。

John?

約翰？

Yeah. Thank you, Sanj. And thanks, Geoff, for your question. Yes. So we very much value our interactions with the FDA and have found them very productive. As I think we mentioned when we announced the program that we had with regard to KPL-387, that we have had interactions with the FDA that laid out the development program.

是的。謝謝你，桑吉。謝謝傑夫的提問。是的。因此，我們非常重視與FDA的互動，並發現這些互動非常有成效。正如我們在宣布 KPL-387 專案時所提到的，我們已經與 FDA 進行了溝通，並制定了開發計劃。

It's important to note that we have already laid out the entirety of the integrated development program, which includes not only the Phase 2 work that is ongoing, but also the subsequent Phase 3 trial that is planned as well as the long-term extensions. So that totality of the package has certainly been assembled. And the communications that we've had have affirmed, if you will, our belief that the Phase 2 trial would be sufficient and pivotal for registration in the US.

值得注意的是，我們已經制定了完整的綜合開發計劃，其中不僅包括正在進行的 2 期工作，還包括計劃中的後續 3 期試驗以及長期擴展計劃。因此，整個方案肯定已經完成。我們之間的溝通也證實了我們先前的信念，即 2 期試驗足以在美國註冊，並且至關重要。

Now that said, we are always looking for opportunities to move the program faster in order to develop what we believe will be potentially transformational and additional therapy for patients and an additional treatment option. So we'll, of course, be looking for ways to do that.

話雖如此，我們一直在尋找機會加快專案進度，以便開發我們認為可能具有變革意義的療法，為患者提供額外的治療選擇。所以，我們當然會想辦法實現這一點。

With regard to 1161, of course, this program is still in its preclinical development activities. And so we'll have more to say about that as we progress. So thanks for the question.

至於 1161，當然，該計畫仍處於臨床前開發階段。隨著事態發展，我們會就此發表更多看法。謝謝你的提問。

Thanks, John. And Geoff, thank you for the questions. This is Ross. So to the part of your question around any difference in persistence rates between the two populations, we haven't seen anything meaningfully different between those two populations, whether it's those patients that have been suffering for two or more recurrences or on their first recurrence, but with additional risk factors signaling potentially longer disease duration, which is, I guess, as expected, we know that these groups of patients generally suffer from chronic multiyear disease. So we haven't seen any meaningful difference between those groups.

謝謝你，約翰。傑夫，謝謝你的提問。這是羅斯。所以，關於你提出的兩個群體之間持續率是否存在差異的問題，我們還沒有發現這兩個群體之間存在任何實質性的差異，無論是已經復發兩次或兩次以上的患者，還是第一次復發但伴有其他風險因素，預示著疾病持續時間可能更長的患者，這似乎也在意料之中，因為我們知道這些患者群體通常會患上慢性疾病持續時間。所以，我們沒有看到這些群體之間有任何實質的差異。

And I think moreover, what we're seeing is that health care professionals have moved their mindsets in how to treat this disease, not only with the utilization of interleukin-1 alpha and beta inhibition opposed to reaching for steroids or other ways of trying to manage this disease, but also in their mindset shift around that this is actually a chronic multiyear disease in most patients and rather than treating for the short term, as used to be the case, particularly with the toxicity and the effects of trying to get patients off corticosteroids treating throughout the duration of the disease with interleukin-1 alpha and beta inhibition is really the goal for the management of these patients. So hopefully, that answers that part of your question as well.

而且我認為，我們現在看到的是，醫療保健專業人員在治療這種疾病方面已經轉變了觀念，不僅體現在他們使用白細胞介素-1α和β抑製劑來代替使用類固醇或其他方法來控制這種疾病，而且也體現在他們觀念的轉變上，即這實際上對大多數患者來說是一種慢性多年疾病，而不是像過去那樣進行短期治療，特別是考慮到皮質類固醇的毒性和試圖讓患者停用皮質類固醇的副作用，在整個疾病過程中使用白細胞介素-1α和β抑製劑進行治療才是管理這些患者的真正目標。希望這也能解答你問題的這一部分。

Thanks, Geoff.

謝謝你，傑夫。

Yes. Thanks, guys.

是的。謝謝各位。

(Operator Instructions) Anupam Rama, JPMorgan.

（操作說明）Anupam Rama，摩根大通。

Hey, guys. This is [Joyce] calling for Anupam. Thanks for taking our question. Maybe just a follow-up on the previous question. For KPL-387, once you've completed the dose focusing Phase 2 portion, how are you thinking about enrollment curve for the Phase 3? And then are you seeing any differences in the types of patients you're enrolling relative to RHAPSODY now that ARCALYST is on the market? Thank you.

嘿，夥計們。這是喬伊斯在呼叫阿努帕姆。感謝您回答我們的問題。或許可以作為對上一個問題的後續。對於 KPL-387，在完成劑量聚焦的 2 期試驗後，您如何考慮 3 期試驗的入組曲線？那麼，隨著 ARCALYST 上市，您發現與 RHAPSODY 相比，您招募的患者類型是否有任何不同？謝謝。

Yeah. No. Thank you for those questions. They were quite excellent. So with regard to the latter portion of your question about the types of patients, what we've described in the study is bringing in patients with recurrent pericarditis. It's important to realize that this is a global study as well. So it's enrolling patients not only in the United States, but also globally.

是的。不。謝謝你提出這些問題。他們非常出色。所以關於你問題後半部提到的患者類型，我們在研究中描述的是收治復發性心包膜炎患者。需要注意的是，這也是一項全球性研究。因此，它不僅在美國，而且在全球範圍內招募患者。

And at this point in time, ARCALYST is available in recurrent pericarditis only in the United States. And so it's a very robust study in terms of the types of populations that it's enrolling. And so the design is very straightforward in that regard.

目前，ARCALYST 僅在美國用於治療復發性心包膜炎。因此，就其招募的人群類型而言，這是一項非常嚴謹的研究。因此，從這個角度來看，設計非常簡單直接。

With regard to the transition to the Phase 3 study, so at this point, what we've guided to is that we would have data from the Phase 2 portion of the trial in the second half of 2026. And we've commented that we anticipate bringing this drug to patients in the 2028, 2029 timeframe. So we have yet to provide guidance on the initiation of the Phase 3 study. And so in that sense, that will -- in clinicaltrials.gov is certainly a very reliable place to look for updates as well as any updates that we provide ourselves.

關於過渡到 3 期研究，目前我們預計，我們將在 2026 年下半年獲得 2 期試驗部分的數據。我們曾表示，預計在 2028 年、2029 年期間將這種藥物帶給患者。因此，我們尚未就啟動 3 期研究提供指導。因此，從這個意義上講，clinicaltrials.gov 無疑是一個查找更新以及我們自己提供的任何更新的非常可靠的地方。

Great. Thank you.

偉大的。謝謝。

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Great. Congrats for the quarter, and then thanks for taking the question. Also a question related to the 387. Just given the current Phase 2/3 and this Phase 2 transition from the standard of therapy, those study design and the planned studies, will this -- the label and then the potential reimbursement test will be similar to the ARCALYST when 387 launched? And then ultimately, when it's available, basically led the physician -- patient to choose between 387 versus ARCALYST? Is that the base case here? Thank you.

偉大的。恭喜你本季取得好成績，也謝謝你回答這個問題。還有一個與387有關的問題。鑑於目前的 2/3 期臨床試驗以及從標準療法過渡到 2 期臨床試驗，以及這些研究設計和計劃中的研究，當 387 上市時，其標籤和潛在的報銷測試是否會與 ARCALYST 類似？最終，當藥物可用時，基本上引導醫生和患者在 387 和 ARCALYST 之間做出選擇？這是基本情況嗎？謝謝。

Well, thanks, Roger, for the question. Maybe I'll deal with the regulatory question and then hand it over to Ross in terms of market penetration. So yes, so with regard to the regulatory program, so as you remember, the ARCALYST program, which was an sBLA at the time, with RHAPSODY, supported a label that was agnostic to a number of recurrences in prior therapy. So it simply states for the treatment of recurrent pericarditis and reduction in risk of recurrence. And so that is a very solid label, which gave us the foundations to grow and evolve the treatment paradigm.

謝謝你的提問，羅傑。或許我會先處理監理方面的問題，然後把市場滲透的問題交給羅斯。是的，關於監管計劃，正如您所記得的，ARCALYST 計劃（當時是一個補充生物製品許可申請）與 RHAPSODY 一起支持了一種不考慮先前治療中多次復發的標籤。所以它只是簡單地說明用於治療復發性心包膜炎和降低復發風險。因此，這是一個非常可靠的標籤，它為我們發展和完善治療模式奠定了基礎。

So the KPL-387 program, as you know, is designed in a very similar way in that except with the difference that it is a full BLA package, meaning that this is the first -- this would be the first labeled indication for KPL-387. And so in that sense, it carries with it a slightly larger base program in terms of some of the initial Phase 1 and Phase 2 work that's being done as well as the larger long-term extensions to provide the safety package.

如您所知，KPL-387 計劃的設計方式非常相似，只是不同之處在於它是一個完整的 BLA 包，這意味著這是第一個——這將是 KPL-387 的第一個標記適應症。因此，從這個意義上講，它包含了一個稍大的基礎計劃，包括一些正在進行的初始第一階段和第二階段的工作，以及更大的長期擴展，以提供安全方案。

But importantly, the core of the study is the Phase 3 pivotal study, which, as you can see on clinicaltrials.gov, bears a remarkable resemblance to the RHAPSODY study design. And of course, we always bring forward new innovations.

但重要的是，該研究的核心是 3 期關鍵性研究，正如您在 clinicaltrials.gov 上看到的那樣，它與 RHAPSODY 研究設計有著驚人的相似之處。當然，我們始終都在推出新的創新產品。

But the goal of the program is to support a similar type of indication statement, if you will, in terms of the population of being able to treat all patients with recurrent pericarditis regardless of prior line of therapy and number of recurrences as long as they have that -- meet that diagnosis of having recurrent pericarditis. So that's the regulatory framework.

但該計畫的目標是支持類似的適應症聲明，也就是說，只要符合復發性心包膜炎的診斷標準，就可以治療所有復發性心包膜炎患者，無論他們先前的治療方案和復發次數如何。這就是監理框架。

I'll now turn it over to Ross to talk about the practice environment.

現在我將把發言權交給羅斯，讓他談談實習環境。

Yeah. Thanks, John. And Roger, thank you for the question. So maybe just best to start off by saying we believe that ARCALYST has a substantial future left to help many, many more patients suffering from recurrent pericarditis.

是的。謝謝你，約翰。羅傑，謝謝你的提問。所以，或許最好先說明，我們相信 ARCALYST 仍有很大的發展前景，可以幫助更多患有復發性心包膜炎的患者。

But also as we progress with KPL-387, this program is aimed to address key patient needs and to expand the market for interleukin-1 alpha and beta inhibition with a target product profile of being less frequent dosing and a streamlined preparation and in a patient-friendly administration format there being the potential to go into an auto-injector.

但隨著 KPL-387 的推進，該計畫旨在滿足關鍵的患者需求，並擴大白細胞介素-1α 和 β 抑制劑的市場，其目標產品特性是減少給藥頻率、簡化製備流程，並採用對患者友好的給藥形式，有可能裝入自動注射器。

So we believe that all those things could be important future treatment option choices for patients. And based on the market research that we have at this stage and what we've shared is that when you look at both patient and health care professional preferences, around 75% of all recurrent pericarditis patients that we shared the target product profile with for both KPL-387, but as well as current commercial and other investigational therapies in recurrent pericarditis, around 75% of those patients said that they would prefer the target product profile of KPL-387.

因此，我們認為所有這些都可能成為患者未來重要的治療選擇。根據我們目前掌握的市場調查數據以及我們分享的信息，從患者和醫療保健專業人員的偏好來看，在我們分享了 KPL-387 的目標產品概況以及目前市售和其他在研的複發性心包炎療法的目標產品概況後，約 75% 的複發性心包炎患者表示他們更喜歡 KPL-387 的目標產品概況。

And when you look on the health care professional side, greater than 90% of health care professionals say that they are highly likely to prescribe KPL-387 for new patients suffering from recurrent pericarditis. So we think that all bodes well for the future, but we continue to be highly focused on ARCALYST as well as the work that we do across our pipeline and portfolio.

從醫療保健專業人員的角度來看，超過 90% 的醫療保健專業人員表示，他們極有可能為患有復發性心包膜炎的新患者開立 KPL-387 處方。所以我們認為這一切都預示著美好的未來，但我們將繼續高度關注 ARCALYST 以及我們在整個研發管線和產品組合中所做的工作。

Excellent. Thank you.

出色的。謝謝。

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

謝謝。今天的問答環節到此結束。我想把這個節目交還給執行長桑吉·帕特爾，請他再補充一些內容。

Thanks, operator, and I appreciate all the questions and all of you for joining the call today. Obviously, we look forward to providing additional updates in the future. I'm sure you can tell from today that we are very energized as we head into this year, and we are going for brilliance as always. So thank you very much for joining.

謝謝接線員，謝謝大家提出的所有問題，也謝謝各位今天參加電話會議。當然，我們期待在未來提供更多更新資訊。從今天大家肯定能看出，我們今年精神飽滿，充滿活力，我們將一如既往地追求卓越。非常感謝您的參與。

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

感謝各位女士、先生參加今天的會議。節目到此結束。您現在可以斷開連線了。再會。