Kiniksa Pharmaceuticals International, PLC (KNSA) 2026 Q3 法說會逐字稿

Thank you for standing by, and welcome to the Kiniksa Pharmaceuticals third-quarter 2026 earnings conference call. (Operator Instructions) As a reminder, today's program is being recorded.

感謝各位稍候，歡迎參加 Kiniksa Pharmaceuticals 2026 年第三季財報電話會議。（接線員指示）提醒各位，今天的會議將被錄音。

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

現在，我想介紹今天會議的主持人，投資人關係部的 Jonathan Kirshenbaum。先生，請開始。

Thank you, operator. Good morning, everyone, and welcome to the Kiniksa Pharmaceuticals third-quarter 2026 earnings call. A press release highlighting our financial results and recent portfolio execution can be found on our website under the Investors section.

謝謝，接線員。各位早安，歡迎參加 Kiniksa Pharmaceuticals 2026 年第三季財報電話會議。一份重點說明我們財務結果與近期產品組合執行情況的新聞稿，可在我們網站「投資人」專區中找到。

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 provide an update on ARCALYST's commercial execution. After that, Mark Ragosa, our Chief Financial Officer, will review our third-quarter 2026 financial results. And finally, Sanj will return at the end of the call to share closing remarks and kick off the Q&A session, for which John Paolini, Kiniksa's Chief Medical Officer, will also be on the line.

關於議程，我們的執行長 Sanj K. Patel 將先做開場介紹。接著，我們的營運長 Ross Moat 將提供 ARCALYST 商業化執行情況的最新進展。之後，我們的財務長 Mark Ragosa 將回顧 2026 年第三季財務結果。最後，Sanj 將在電話會議尾聲回來分享結語並開始問答環節；Kiniksa 的醫務長 John Paolini 也將一同在線上參與。

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 of the date of this presentation, and we undertake no obligation to update such statements, except as required by law.

在開始之前，請注意我們今天將發表前瞻性陳述；此類陳述受風險與不確定性影響，可能導致實際結果與陳述內容出現重大差異。關於這些陳述與風險因素的說明，可在本投影片中以及我們向 SEC 提交文件中「風險因素」標題下查閱。這些陳述僅截至本簡報日期有效；除法律要求外，我們不承擔更新此類陳述的義務。

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

接下來把時間交給 Sanj。

Thanks, Jonathan, and good morning or good afternoon, everyone. Over the last 10, 11 years, we've built this company through multiple stages of growth. And today, I'm as excited as ever about what the team and I can accomplish together in the years ahead.

謝謝你，Jonathan。各位早安或午安。在過去 10、11 年裡，我們歷經多個成長階段打造了這家公司。而今天，我對於未來幾年我與團隊能共同達成的成果，依然和以往一樣充滿期待。

Kiniksa continues to build a leading IL-1 alpha and beta inhibition franchise, driven by the commercialization of ARCALYST in recurrent pericarditis, as well as our progress with KPL-387 and KPL-1161. This morning, we announced via a press release that we've raised our full-year revenue guidance to between $1.045 billion and $1.050 billion. We continue to see robust growth with ARCALYST in recurrent pericarditis, driven by strong execution and strategic investments across the business.

Kiniksa 持續打造領先的 IL-1 α 與 β 抑制產品線，動能來自 ARCALYST 在復發性心包炎的商業化，以及我們在 KPL-387 與 KPL-1161 的進展。今天早上，我們透過新聞稿宣布，已將全年營收指引上調至 10.45 億至 10.50 億美元。我們持續看到 ARCALYST 在復發性心包炎領域的強勁成長，這得益於有力的執行力以及在全公司範圍內的策略性投資。

On the clinical side, we're excited about the progress of KPL-387 and KPL-1161. The pivotal Phase 3 study with KPL-387 continues to enroll and dose patients. We announced today that we expect data from this trial in the second half of 2027. The team and I are really looking forward to potentially launching this drug in the '28, '29 timeframe. In addition to providing an important treatment option for patients with recurrent pericarditis, we believe KPL-387 could help grow the market by enabling a once-monthly subcu dosing.

在臨床方面，我們對 KPL-387 與 KPL-1161 的進展感到振奮。KPL-387 的關鍵性第三期研究持續招募並為病患給藥。我們今天宣布，預期將在 2027 年下半年取得該試驗數據。我和團隊非常期待有機會在 2028、2029 年的時間框架內推出這款藥物。除了為復發性心包炎患者提供重要的治療選擇外，我們也相信 KPL-387 透過每月一次的皮下注射（subcu）給藥，有助於擴大市場。

We're also on track to have KPL-1161, our quarterly IL-1 alpha and beta inhibitor, in a Phase 1 clinical trial by the end of this year. Importantly, Kiniksa's robust financial profile allows us to continue to invest in penetrating the recurrent pericarditis market and growing the IL-1 alpha and beta inhibition franchise while also pursuing additional value-creating opportunities.

我們也按計畫推進，預計在今年年底前讓 KPL-1161（我們的每季一次 IL-1 α 與 β 抑制劑）進入第一期臨床試驗。重要的是，Kiniksa 強健的財務狀況使我們能持續投資於提高復發性心包炎市場滲透率並擴大 IL-1 α 與 β 抑制產品線，同時也追求其他可創造價值的機會。

In the third quarter, we saw a continuation of strong ARCALYST momentum with Q3 revenue of $286 million. The penetration rate into the annual population of 14,000 multiple recurrence patients increased to 23% as of the end of Q3. As shown by the increased breadth and depth of prescribing over time, adoption of IL-1 alpha and beta inhibition continues to expand among the approximately 40,000 recurrent pericarditis patients each year.

在第三季，我們看到 ARCALYST 的強勁動能延續，第三季營收為 2.86 億美元。截至第三季末，在每年約 14,000 名多次復發患者中的滲透率提升至 23%。從處方覆蓋廣度與深度隨時間增加可見，IL-1 α 與 β 抑制療法在每年約 40,000 名復發性心包炎患者中的採用持續擴大。

The underlying fundamentals that propelled our commercial success remain strong. Since launch, we've observed robust payer approval, strong patient compliance, and greater appreciation of the need to treat throughout the multi-year duration of the disease.

推動我們商業成功的基本面依然強勁。自上市以來，我們觀察到保險給付核准表現強勁、患者依從性良好，以及對於在疾病多年的病程期間持續治療必要性的認知提升。

Underpinning this growth is strong execution by our commercial organization and data-driven investments in ARCALYST. Our AI-supported patient identification initiatives and targeted direct-to-consumer campaign, Heart's Home, have positively contributed to growing patient and physician awareness of recurrent pericarditis and the important role of IL-1 alpha and beta inhibition in controlling this debilitating disease.

支撐此成長的是我們商業團隊的強力執行，以及以數據為導向對 ARCALYST 的投資。我們以 AI 支援的患者辨識計畫與針對消費者的定向宣傳活動 Heart's Home，對提升患者與醫師對復發性心包炎的認知，以及 IL-1 α 與 β 抑制在控制此致殘疾病中的重要角色，均帶來正面貢獻。

As you've heard, we now expect ARCALYST to achieve over $1 billion in revenue in 2026, and we look forward to continuing to bring this blockbuster drug to more patients suffering from this debilitating disease. In order to grow the recurrent pericarditis market over the next several years, we plan to drive greater adoption in both the 14,000 multiple recurrence patients annually and the additional 26,000 patients annually that are experiencing their first recurrence.

如各位所聽到的，我們目前預期 ARCALYST 在 2026 年的營收將超過 10 億美元；我們也期待持續讓更多受此致殘疾病所苦的患者使用這款重磅藥物。為了在未來幾年擴大復發性心包炎市場，我們計畫推動在每年 14,000 名多次復發患者，以及另外每年 26,000 名首次復發患者中的更高採用率。

Kiniksa is executing against its strategy to help more patients, drive more ARCALYST growth, and advance KPL-387 and KPL-1161. This trajectory will help put the company on a path to having multiple commercial products, continued strong and profitable growth, and the flexibility to invest in future value creation. I can tell you that the team and I won't rest until we've helped many, many more patients.

Kiniksa 正依其策略執行，以幫助更多患者、推動 ARCALYST 進一步成長，並推進 KPL-387 與 KPL-1161。這一發展軌跡將協助公司走向擁有多項商業化產品、持續強勁且具獲利性的成長，並具備投資未來價值創造的彈性。我可以告訴各位，我和團隊在幫助更多、更多患者之前不會停下腳步。

And now, our President and COO, Ross Moat.

接下來有請我們的總裁兼營運長 Ross Moat。

Thank you, Sanj.

謝謝你，Sanj。

As you've heard, we're pleased with the continued strength of our commercial performance with ARCALYST, and we're even more excited by the substantial growth opportunity ahead. We continue to be highly focused on further increasing the penetration rates into the many thousands of recurrent pericarditis patients and continuing to evolve the treatment paradigm towards interleukin-1 alpha and beta inhibition.

如各位所聽到的，我們對 ARCALYST 持續強勁的商業表現感到滿意，並對前方可觀的成長機會更加振奮。我們仍高度聚焦於進一步提升在數以千計復發性心包炎患者中的滲透率，並持續推動治療典範朝向白介素-1 α 與 β 抑制演進。

As illustrated on the left side of this slide, physicians continue to report an increasing consideration of ARCALYST earlier in the disease course, including at the first recurrence. Additionally, we also see a growing appreciation for ARCALYST to be utilized earlier in the line of therapy, meaning after NSAIDs and colchicine, and, importantly, prior to corticosteroids, as ratified in the 2025 American College of Cardiology Concise Clinical Guidance for Recurrent Pericarditis. In fact, approximately 50% of physicians surveyed now support this treatment approach, representing a doubling from levels over the last three years prior to the publication of this independent guidance.

如本投影片左側所示，醫師持續回報在疾病進程更早期、包括首次復發時，對 ARCALYST 的考量度正在提高。此外，我們也看到對於 ARCALYST 應更早用於治療序列的認同正在增加，也就是在 NSAIDs 與秋水仙素之後，且重要的是在皮質類固醇之前；此點已在《2025 年美國心臟學會（American College of Cardiology）復發性心包炎精要臨床指引》中獲得確認。事實上，目前約 50% 的受訪醫師支持此治療方式，較該獨立指引發布前三年期間的水準增加一倍。

As we continue to build and lead this market, our team are laser-focused on value-driven investments that aim to increase market penetration and help many more patients. Increasing education and awareness on recurrent pericarditis, ARCALYST, and the new treatment paradigm remain critical components of our strategy, and we've enhanced our capabilities through the use of AI and machine learning to reach a larger audience.

在我們持續建立並引領此市場的同時，團隊正高度聚焦於以價值為導向的投資，目標是提升市場滲透率並幫助更多患者。提升對復發性心包炎、ARCALYST 以及新治療典範的教育與認知，仍是我們策略的關鍵組成；我們也透過運用 AI 與機器學習強化能力，以觸及更廣泛的受眾。

On the healthcare professional side, we've done this through improving our data sources to inform us not only which healthcare professionals we should be seeing but, importantly, when we should be seeing them. On the patient side, we've seen encouraging early indicators from our Heart's Home direct-to-consumer campaign. Based on this initial traction, we plan to expand the campaign with additional content and outreach initiatives aimed at empowering more patients to engage with their healthcare professionals about ARCALYST.

在醫療專業人員端，我們透過改善數據來源來達成這點，讓我們不僅知道應該拜訪哪些醫療專業人員，更重要的是知道應該在何時拜訪他們。在患者端，我們從 Heart's Home 的直接面向消費者宣傳活動中看到令人鼓舞的早期指標。基於這些初步動能，我們計畫以更多內容與外展計畫擴大該活動，目標是賦能更多患者與其醫療專業人員就 ARCALYST 進行討論。

As a reminder, Heart's Home is a highly targeted DTC campaign where we've innovated from traditional DTC by using AI to produce and deliver a campaign that's effective for a rare disease audience. This campaign is aimed at educating an enriched population of likely recurrent pericarditis patients who are currently not taking ARCALYST and empowering them to discuss ARCALYST with their healthcare provider.

提醒一下，Heart's Home 是一項高度精準鎖定的 DTC（直接面向消費者）行銷活動；我們運用 AI 來製作並投放活動，從傳統 DTC 進行創新，使其對罕見疾病受眾更具成效。此活動旨在教育一群經強化篩選、可能罹患復發性心包膜炎且目前未使用 ARCALYST 的族群，並賦能他們與其醫療照護提供者討論 ARCALYST。

As an early indicator of the impact of this campaign, we've seen a 12-fold increase in the traffic to our ARCALYST websites compared to baseline levels prior to the campaign. Additionally, there's been an eight-fold increase with engaged sessions, meaning visits where the individual spends meaningful time on the website or interacts with the content.

作為此活動影響力的早期指標，相較於活動前的基準水準，我們看到 ARCALYST 網站流量提升了 12 倍。此外，互動式工作階段（engaged sessions）也增加了 8 倍，意指訪客在網站上停留了有意義的時間或與內容互動的造訪。

More importantly, approximately 55% of patients who saw the ad strongly agreed that they are motivated to speak with their healthcare provider about ARCALYST. All of these indicators are strong signals that our digital strategy is reaching the right audience and is empowering action.

更重要的是，約 55% 看過廣告的患者強烈同意，他們有動機與其醫療照護提供者討論 ARCALYST。所有這些指標都強烈顯示，我們的數位策略正觸及正確受眾，並促使其採取行動。

As this disease has a very high annual incident rate of patients coming into the labeled indication, this DTC initiative is nicely supplementing our robust execution in the field and helps us to address the substantial opportunity that we have ahead to help many more patients. As previously mentioned, our interleukin-1 alpha and beta inhibition franchise is growing, is profitable, and has significant opportunity in the months and years ahead.

由於此疾病每年進入核准適應症標示範圍的新增患者發生率非常高，這項 DTC 計畫正好補強我們在第一線的強勁執行力，並協助我們把握眼前龐大機會，以幫助更多患者。如先前所述，我們的白介素-1（IL-1）α 與 β 抑制產品線正在成長、具備獲利能力，且在未來數月與數年仍有顯著機會。

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

接下來，我把電話交給 Mark，請他回顧我們的財務結果。

Thanks, Ross.

謝謝你，Ross。

Our third quarter delivered continued ARCALYST sales growth, advancement of KPL-387 and KPL-1161 development, and a solid financial position. This morning, I'll review our financial results and key performance drivers. Detailed financial information is available in today's press release.

我們第三季持續實現 ARCALYST 銷售成長、推進 KPL-387 與 KPL-1161 的開發進度，並維持穩健的財務狀況。今天早上，我將回顧我們的財務結果與關鍵績效驅動因素。更詳細的財務資訊已載於今日的新聞稿。

Starting with the income statement, ARCALYST revenue grew 58% year over year to $286 million in the third quarter, driven by continued gains in patient and physician adoption. Operating expenses increased year over year, driven by higher ARCALYST revenue, which resulted in additional cost of goods sold and collaboration expenses, advancement of KPL-387 development, which drove additional R&D investment, and support of ARCALYST commercialization to reach more patients, which led to additional SG&A investment. Operating income rose to $54.2 million and net income to $47.3 million, both up significantly year over year.

先從損益表開始，第三季 ARCALYST 營收年增 58% 至 2.86 億美元，主要受惠於患者與醫師採用度持續提升。營業費用較去年同期增加，主要由 ARCALYST 營收提高所帶動，進而產生額外的銷貨成本與合作費用；KPL-387 開發推進帶來額外研發（R&D）投入；以及為觸及更多患者而支持 ARCALYST 商業化，導致額外的銷售、一般及行政（SG&A）投入。營業利益提升至 5,420 萬美元，淨利提升至 4,730 萬美元，兩者皆較去年同期大幅成長。

Turning to the calculation of ARCALYST collaboration profit, which drives total collaboration expenses on our income statement. ARCALYST collaboration profit increased 67% year over year to $211.6 million, outpacing sales growth and reflecting disciplined commercial investment.

接著談 ARCALYST 合作利潤的計算方式，該項目會驅動我們損益表上的合作費用總額。ARCALYST 合作利潤年增 67% 至 2.116 億美元，增幅超越銷售成長，反映出嚴謹的商業投資紀律。

Next, we ended the third quarter with $568.8 million in cash, reflecting approximately $43 million in net cash generation during the quarter.

接下來，我們在第三季末的現金為 5.688 億美元，反映本季約 4,300 萬美元的淨現金創造。

Looking ahead, in addition to our updated 2026 ARCALYST sales guidance of $1.045 billion to $1.050 billion, we are providing full-year R&D and SG&A expense guidance. We expect full-year R&D expenses of $160 million to $170 million in 2026. This range includes continued development of KPL-387 and KPL-1161 as well as significant fourth-quarter KPL-387 pre-commercial manufacturing costs.

展望未來，除更新 2026 年 ARCALYST 銷售指引為 10.45 億至 10.50 億美元外，我們也提供全年研發與 SG&A 費用指引。我們預期 2026 年全年研發費用為 1.60 億至 1.70 億美元。此區間包含 KPL-387 與 KPL-1161 的持續開發，以及第四季 KPL-387 顯著的商業化前製造成本。

We expect full-year SG&A expenses of $270 million to $280 million in 2026. This range supports continued ARCALYST commercialization, including additional personnel and promotional activities in the fourth quarter to further build disease awareness and enhance patient and physician targeting.

我們預期 2026 年全年 SG&A 費用為 2.70 億至 2.80 億美元。此區間支持 ARCALYST 持續商業化，包括在第四季增加人員與推廣活動，以進一步提升疾病認知，並強化患者與醫師的精準鎖定。

In closing, our third-quarter results show the strength of our operating plan, a growing and profitable ARCALYST business, funding the advancement of key development assets and positioning us to create value in the near and long term.

總結而言，我們第三季的結果展現了營運計畫的強勁、ARCALYST 業務的成長與獲利能力，並為關鍵開發資產的推進提供資金，使我們得以在短期與長期創造價值。

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

接下來，我把電話交回給 Sanj，請他做結語。

Thanks, Mark.

謝謝你，Mark。

As you've heard, Kiniksa is surely well positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. The team and I are on it and focused on helping as many patients as possible with ARCALYST and to advancing the development of our clinical portfolio in order to bring additional therapies to patients.

如各位所聽到的，隨著我們擴大 IL-1 α 與 β 抑制產品線，Kiniksa 的確處於有利位置，可在未來創造可觀價值。團隊與我正全力以赴，專注於透過 ARCALYST 盡可能幫助更多患者，並推進我們臨床產品組合的開發，以便為患者帶來更多治療選項。

With that, I'll turn it back to the operator for questions. Thank you.

接下來，我把電話交回給接線員進行提問。謝謝。

Anupam Rama, JPMorgan.

JPMorgan 的 Anupam Rama。

Hey, guys. Thanks so much for taking the question, and congrats on the quarter. I just wanted to ask a quick KPL-387 question. I think the guidance for pivotal data in the second half of 2027 is new today. So can you tell us what you're seeing in terms of enrollment dynamics and where you are on site initiation that give you confidence to laying out this timeline? Thanks so much.

嗨，各位。非常感謝讓我提問，也恭喜本季表現。我想快速問一個關於 KPL-387 的問題。我認為今天提出的「2027 年下半年取得關鍵性（pivotal）數據」指引是新的。所以能否談談你們在受試者入組（enrollment）動態與試驗中心啟動（site initiation）方面看到的情況，哪些因素讓你們有信心提出這個時程？非常感謝。

Thanks, Anupam. I think I'll have John Paolini answer that. Suffice to say that our execution cost is not just commercial, but also the development organization.

謝謝你，Anupam。我想請 John Paolini 來回答。簡而言之，我們的執行力不僅體現在商業端，也體現在開發組織。

And as I've said before, we are enrolling and dosing patients to global clinical study with global sites. And both myself, John, and Ross take pride in meeting with investigators and just getting them excited about the future. So there's been some massive momentum, both internally and with our investigators. And as with that, when we go out things with full force, and that's why the guidance is as well as having results in the second half of next year.

如我之前所說，我們正在一項全球性臨床研究中，於全球各試驗中心進行患者入組與給藥。我、John 和 Ross 都以與研究者會面為榮，並讓他們對未來感到振奮。因此，無論在內部或在研究者端，都出現了非常強的動能。也正因如此，當我們全力推進時，才會給出這樣的指引，也就是在明年下半年取得結果。

But John?

John？

Yeah. I think that's excellent guidance from Sanj. The only thing that I would add is that on clinicaltrials.gov, you can see the extent of the global nature of our program, and so the sites that are involved in the program across the world are all listed there, and so you can see the scope of effort. And as Sanj mentioned, we are on the ground and engaging with clinicians, and we can feel the excitement about the program and so we continue forward.

是的。我認為 Sanj 給出的指引非常到位。我唯一想補充的是，在 clinicaltrials.gov 上，你可以看到我們計畫的全球化程度；參與該計畫的全球各地試驗中心都列在上面，因此你能看到投入工作的規模。而如 Sanj 所提到的，我們在第一線與臨床醫師互動，也能感受到大家對此計畫的興奮，因此我們會持續推進。

I'd also say we have a cracked clinical operations team. Having run clinical operations for many years at Genzyme before I run commercial, I've got a very high bar for clinical research and clinical operations. And after many, many years, I feel like we've really got the best team to do the job.

我也想說，我們有一支非常強悍的臨床營運團隊。在我轉任商業職務之前，我在 Genzyme 多年負責臨床營運，因此我對臨床研究與臨床營運的標準非常高。而在多年之後，我覺得我們確實擁有最適合完成這項工作的最佳團隊。

Thanks so much for taking our question, and congrats again on the quarter.

非常感謝讓我們提問，也再次恭喜本季表現。

Edward Nash, Canaccord Genuity.

Canaccord Genuity 的 Edward Nash。

Hey. Good morning, guys. I'm really excited to see that over $1 billion number now for the guidance. So congratulations.

嗨，早安，各位。我很興奮看到指引現在已經超過 10 億美元這個數字了。所以恭喜。

I just wanted to ask, now, you're at 23% active penetration. That's 2% higher than last quarter, which is really, I think, impressive. Can you maybe give us an idea of how we should think about the shape of the penetration curve from here? Is there anything structurally different about the next quartile of patients versus the patients you've already converted?

我想問的是，你們目前的活躍滲透率是 23%。比上一季高了 2%，我覺得這真的很令人印象深刻。你們能否談談，從現在開始我們應該如何看待滲透率曲線的走勢？接下來那一個四分位（quartile）的患者，與你們已經轉換過的患者相比，在結構上是否有任何不同？

You're going up on the SG&A number, which makes a lot of sense, and you've put a lot of focus on the DTC campaign, which clearly seems to be paying off. Just kind of curious as to how many extra dollars need to be put in to kind of achieve greater uptake of scripts.

你們上調了 SG&A 的數字，這很合理，而且你們也把很多重點放在 DTC 活動上，顯然正在見效。我只是有點好奇，為了讓處方量（scripts）進一步提升，大概還需要投入多少額外資金？

Thanks, Edward. This is Ross. So thanks very much for your comments.

謝謝你，Edward。我是 Ross。非常感謝你的評論。

And yeah, we're pleased to announce that we were around 23% at the end of the quarter in terms of penetration into the multiple recurrence group, which is the patients that have suffered for two or more recurrences. And that's without allocating anything to the first recurrence group, which we've got about 20% of our prescriptions in the first recurrence group also.

是的，我們很高興宣布，就多次復發族群（也就是曾經歷兩次或以上復發的患者）而言，本季末的滲透率約為 23%。而且這還是在我們沒有把任何處方分配到首次復發族群的情況下；事實上，我們也有大約 20% 的處方來自首次復發族群。

So the opportunity is very significant, while on one hand, we're happy with the 23% and that's obviously showing a couple of percent growth versus the end of Q2 number when we shared it. The time before that, the last time we shared the penetration number, I think it was in the end of Q4, which was 18% at the end of last year. So that's been growing relatively nicely, but I think more importantly is the opportunity that's ahead.

因此機會非常可觀。一方面，我們對 23% 的表現感到滿意，這顯然相較於我們在第二季末分享的數字成長了幾個百分點。在那之前，我們上一次分享滲透率數字，我記得是在第四季末，也就是去年年底的 18%。所以這段期間成長相當不錯，但我認為更重要的是前方仍有很大的機會。

I mean, clearly, there are a lot of patients in the two-plus recurrence group that we've still got to help, and as I said, not allocating for even those who are in the first recurrence. And as we shared from some of the market research today, the propensity and the desire for physicians to look and treat patients with IL-1 alpha beta inhibition in the first group has also been growing quite substantially over time. So we think the future is very bright from that perspective.

我的意思是，很明顯地，在兩次以上復發族群中，仍有許多患者需要我們協助；而且如我所說，我們甚至還沒有把首次復發的患者納入分配。另外，正如我們今天分享的一些市場研究所示，醫師在首次復發族群中採用並治療、以 IL-1 α/β 抑制為機制的治療方式之傾向與意願，也隨時間顯著提升。因此從這個角度來看，我們認為未來非常光明。

In terms of kind of different patient groups, aside from the recurrence number, there's really not much else to report. We're not seeing significant change necessarily in the demographics of the patients or severity levels or anything else. It's just that this is a rare flare in cardiovascular disease. There are a lot of patients out there relative to a rare disease. And we're trying to get out and reach as many patients as possible.

就不同患者族群而言，除了復發次數之外，其實沒有太多其他可報告的。我們沒有看到患者的人口統計特徵、嚴重程度或其他方面出現顯著變化。只是這在心血管疾病領域屬於罕見的急性發作。相對於罕見疾病而言，實際上仍有相當多患者。我們正努力走出去，觸及盡可能多的患者。

We know that they are widely dispersed around the country, and that takes a certain effort as you have alluded to from our kind of our sales and marketing spend and so on. But our efforts are ultimately on value-driven investments that can make sure we reach those physicians and switch more and more of them on to this new way of treating and ultimately get greater penetration into this opportunity to ultimately help more patients.

我們知道這些患者分散在全國各地，正如你所提到的，這需要一定的投入，包括我們的銷售與行銷支出等。但我們的努力最終聚焦在以價值為導向的投資，確保我們能觸及這些醫師，讓越來越多醫師轉向採用這種新的治療方式，並在這個機會中取得更高的滲透率，最終幫助更多患者。

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

非常感謝。抱歉，你請繼續。

Yeah. No, Edward, maybe just to add the final part as well as the DTC spend and field team spend that we have and we've announced in our guidance looking forward as well is ultimately very efficient. We are very focused on this rare disease market.

好的。沒有，Edward，我想也補充最後一點：我們在指引中所提到、展望未來的 DTC（直接面向消費者）支出與外勤團隊支出，最終都非常有效率。我們非常專注於這個罕見疾病市場。

And for the DTC side of things, this is not kind of broad spectrum. Massive spend DTC is very efficient, very targeted type of expenditure to address appropriately the market that we have.

就 DTC 這一塊而言，這不是那種廣泛撒網、巨額投入的模式；DTC 的投入非常有效率、非常精準，屬於針對我們所面對市場的適切支出。

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

很好。謝謝你補充更多細節，也恭喜這一季表現非常出色。再次感謝。恭喜。

Paul Choi, Goldman Sachs.

Paul Choi，高盛。

Hi, everyone. Congratulations on the great quarter, and congrats, Ross, as well on the new title. I want to ask on the 387 (inaudible) strategy, and I was wondering if you could just sort of provide a little more color on where you are with progress on that. I guess what the ultimate data you're looking for there to support 387 from an insurance perspective.

各位好。恭喜本季表現亮眼，也恭喜 Ross 獲得新職稱。我想問一下 387（聽不清）策略，我想請你們再多提供一些目前進展的細節。我想了解的是，從保險給付的角度，你們最終希望取得哪些數據來支持 387。

And my second question is, on 1161, maybe just where are you thinking in terms of indication selection, I guess, at this point, and a little bit more on the criteria that you're considering for the first indication there for 1161. Thank you so much.

第二個問題是關於 1161：目前你們在適應症選擇方面的思考進展到哪一步？以及你們在為 1161 選定第一個適應症時，正在考量哪些標準？非常感謝。

Thank you, Paul. I appreciate your questions. This is John.

謝謝你，Paul，我很感謝你的問題。我是 John。

So with regard to the KPL-387 transition to monotherapy dosing and administration study, this study is designed primarily as what we call a posology study. So it covers dosing administration specifically for informing the label. So it's designed, as you can see in the slides, for looking at how patients are coming from stable therapies, whether they're oral or biologic, and then transitioning to KPL-387 monotherapy at the 300-milligram subcutaneous monthly dose level.

關於 KPL-387 轉換至單藥治療之劑量與給藥研究，這項研究主要設計為我們所稱的「用法用量（posology）」研究。因此它涵蓋的是劑量與給藥方式，特別是用來提供標籤（label）資訊。如投影片所示，研究設計是觀察患者如何從穩定治療（不論是口服或生物製劑）轉換為 KPL-387 單藥治療，採用每月一次、300 毫克皮下注射的劑量水準。

And so that's really what that study is designed to do. It follows very similarly the precedent of what's in the ARCALYST label, which similarly describes the transitions from NSAIDs, colchicine, corticosteroids, and anakinra. So this is just really following in that tradition. So that's how the study is designed and the data that will be generated.

因此，這就是該研究的主要目的。其設計非常類似於 ARCALYST 標籤中的先例，該標籤同樣描述了從 NSAIDs、秋水仙素、皮質類固醇以及 anakinra 的轉換。所以這只是延續同樣的做法。這就是研究設計方式以及將產生的數據類型。

But I'll turn it over to Ross to talk about, ultimately, other elements of transition.

不過我會把問題交給 Ross，來談談最終在轉換方面的其他要素。

Yeah. Thanks very much, John.

好的。非常感謝你，John。

I mean, I guess just to say that obviously we're very excited about the potential for KPL-387, but everything's kind of data-dependent as we move forward. But when we tested the target product profile for KPL-387, both with healthcare professionals and patients. We were really very encouraged by the feedback that we had back.

我的意思是，我想先說我們對 KPL-387 的潛力當然非常興奮，但隨著我們往前推進，一切都取決於數據。不過當我們針對 KPL-387 的目標產品特性（target product profile）同時向醫療專業人士與患者進行測試時，我們對回饋結果感到非常鼓舞。

And while we believe that ARCALYST has a lot of growth left in it to address the recurrent pericarditis opportunity, with KPL-387, patients did tell us that around 75% of them would prefer the KPL-387 target profile being a monthly liquid formulation, potentially auto-injector over current commercial or other investigational therapies. They also reported a propensity for a greater number of patients to start on therapy with that target product profile as well as staying on therapy longer.

雖然我們相信 ARCALYST 在解決復發性心包膜炎的市場機會上仍有很大的成長空間，但就 KPL-387 而言，患者告訴我們，約有 75% 的患者更偏好 KPL-387 的目標特性：每月一次的液體劑型，且可能採用自動注射器，相較於目前已上市或其他研發中的治療。他們也表示，採用該目標產品特性的情況下，會有更多患者傾向開始治療，並且更願意在治療上維持更長時間。

And then when you looked at the healthcare professional side, 92% of healthcare professionals indicated a high likelihood to prescribe KPL-387 with that target product profile over available commercial or other investigational therapies. So that, I think, reads quite positively about the future, but ultimately, we are focused on conducting the clinical research and awaiting the data.

再看醫療專業人士端，有 92% 的醫療專業人士表示，相較於現有已上市或其他研發中的治療，他們很可能會在該目標產品特性下開立 KPL-387。因此我認為這對未來是相當正面的訊號，但最終我們仍專注於進行臨床研究並等待數據結果。

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

至於你關於 1161 的問題，我們對這個計畫也非常興奮；它有望達到每季一次給藥，同樣是透過鎖定受體來抑制 IL-1 α 與 β 的訊號傳導。我們預期在今年年底前啟動第一期（Phase 1）計畫。

And to that extent, we have not yet announced or disclosed our plans with regard to development, indications. Suffice it to say, though, that with that longer duration of action, that really unlocks a lot of potential for disease states, especially those that are chronic or lifelong in nature by virtue of the once quarterly dosing.

在這個階段，我們尚未公布或揭露關於開發與適應症的計畫。不過可以說的是，憑藉更長的作用時間、每季一次給藥，確實能為許多疾病狀態解鎖很大的潛力，特別是那些屬於慢性或終身性的疾病。

Ross, anything to add?

Ross，還有要補充的嗎？

No. That's great, John. Thank you.

沒有。很棒，John。謝謝。

Roger Song, Jefferies.

Roger Song，Jefferies。

All right. This is Peter calling in for Roger. Congrats on a good quarter, and thanks for taking our questions.

好的。我是 Peter，代替 Roger 來電。恭喜本季表現不錯，也謝謝你們回答我們的問題。

Just a couple quick ones from us. For the third quarter, can you tell us what share of the new patients came from first-time versus 3P prescribers? And can you also share how much growth you see within the first recurrence patients as well for this quarter?

我們這邊有幾個簡短問題。就第三季而言，你們能否告訴我們，新患者中有多少比例來自首次開立處方的醫師，多少來自 3P 開立者？另外，你們也能分享一下，本季在首次復發患者族群內，你們看到多少成長嗎？

Yeah. Peter, thanks very much for the questions.

是的。Peter，非常感謝你的提問。

We don't share some of that data directly externally, but of course, it's the type of thing that we look at a lot internally in the business. What we have shared is this in the Q3. Clearly, we've seen a substantial uplift in the number of patients representing the strong growth of $42 million, near $42.5 million quarter on quarter, and ultimately, that's driven by strong prescriber growth.

我們不會直接對外分享其中一些數據，但當然，這類資訊我們在公司內部業務上會大量檢視。我們在第三季所分享的是：很明顯地，我們看到病患人數大幅提升，帶動營收季增4,200萬美元、接近4,250萬美元；而最終這是由處方醫師人數的強勁成長所驅動。

What we have said is that when you look at the total number of prescribers launched to date of ARCALYST for recurrent pericarditis in Q3, I should say at the end of Q3, we had around 5,450 total prescribers. Now, that's an uplift of around 450 quarter on quarter. So again, it's really showing very strong growth. And now, we have around 30% of that group who are repeat prescribers, which is up by around 170 prescribers.

我們也提到，當你看截至第三季（我應該說第三季末）為止，針對復發性心包膜炎已開立過 ARCALYST 的處方醫師總數，我們約有5,450位。這比上一季增加約450位。所以再次顯示非常強勁的成長。而且目前其中約30%為重複開立處方的醫師，較上一季增加約170位醫師。

Historically, we've said that the split between the first and second recurrence is about 80% of prescriptions in the second plus recurrence and 20% in the first, but we haven't updated that data on a very frequent basis as a lot of it comes from kind of ad hoc market research that we do. But clearly, we're showing pretty strong growth in Q3. And a lot of that is down to the refined targeting that we have with our field team, the DTC campaign in a very targeted approach, and also just broader dissemination of the ACC Concise Clinical Guidance and really just empowering physicians on this new way of treating the disease.

過去我們曾說，第一次與第二次復發之間的分布大約是：第二次以上復發約占80%的處方，第一次復發約占20%；但我們並未非常頻繁地更新這項數據，因為其中很多來自我們進行的臨時性市場調查。但很明顯地，我們在第三季呈現相當強勁的成長。其中很大一部分來自我們外勤團隊更精準的目標鎖定、以非常聚焦方式進行的 DTC（直接面向消費者）宣傳活動，以及 ACC《精簡臨床指引》的更廣泛傳播，真正讓醫師能夠掌握這種治療疾病的新方式。

Got it. Thanks so much for the additional color, and congrats again on the quarter.

了解。非常感謝你補充更多細節，也再次恭喜本季表現。

Geoff Meacham, Citi.

Citi 的 Geoff Meacham。

Hey, guys. Great job on the quarter. Thanks for the question.

嗨，各位。本季做得很棒。謝謝讓我提問。

Just have a couple of quick ones. The first on 387, I know convenience angle obviously is a big differentiator. But beyond that, is there a patient maybe on ARCALYST today that you think is particularly suited to transition to 387? Just beyond convenience, I know clinically, maybe those that live further away, or what are the attributes of the patients, I guess is the question that would maybe more rapidly switch.

我有幾個簡短問題。第一個關於 387，我知道便利性顯然是一個很大的差異化因素。但除此之外，是否有某類目前使用 ARCALYST 的病患，你們認為特別適合轉換到 387？也就是說，除了便利性之外，我知道臨床上可能是住得更遠的病患之類；我想問的是，哪些病患特徵可能會更快轉換。

And then bigger picture question just on the cash and the capital deployment, you guys have been consistently profitable. You're billing some cash on the balance sheet. I don't know, just trying to think of ways to maximize value from a balance sheet cash flow context. What are you thinking about from a BD perspective? Where does this fall in your priorities? Thank you.

然後是一個更宏觀的問題，關於現金與資本配置：你們一直維持獲利。資產負債表上也累積了一些現金。我在想，從資產負債表與現金流的角度，有哪些方式可以最大化價值。你們在 BD（商務拓展）方面有什麼想法？這在你們的優先順序中排在哪裡？謝謝。

Thank you, Geoff, for your question. I'll tackle this first part with regard to the transition, if you will, from ARCALYST to KPL-387.

謝謝你，Geoff，謝謝你的提問。我先回答第一部分，也就是你所說從 ARCALYST 轉換到 KPL-387 的議題。

I mean, I think that our position with regard to the management of the disease is that blockade of IL-1 alpha and IL-1 beta is critical to maintaining disease control and to gaining the disease control as a monotherapy. And so in that sense, we're particularly excited about the KPL-387 program because it adds to the optionality of what's available to patients and physicians in terms of treating this disease. And so that efficacy ultimately remains to be demonstrated in the Phase 3 pivotal trial, which is ongoing.

我的意思是，我們對於疾病管理的立場是：阻斷 IL-1 alpha 與 IL-1 beta 對於維持疾病控制、以及以單一療法達到疾病控制都至關重要。因此在這個意義上，我們對 KPL-387 計畫特別興奮，因為它增加了病患與醫師在治療此疾病時可選擇的方案。而其療效最終仍需在正在進行的第三期關鍵性試驗中加以證明。

But importantly, what we have going on as well is the 212 study or the KPL-387 transition to monotherapy dosing and administration study, which is really designed to look at the mechanics of how to transition from one existing therapy to KPL-387 monotherapy, the 300-milligram monthly dose level. And so that includes NSAIDs and colchicine, corticosteroids, or IL-1 pathway inhibitors, including anakinra and rilonacept.

但同樣重要的是，我們也在進行 212 研究，也就是 KPL-387 轉換至單一療法之劑量與給藥方式研究；其設計目的主要是觀察如何從既有治療轉換到 KPL-387 單一療法，也就是每月300毫克的劑量。因此其中涵蓋 NSAIDs 與秋水仙素、皮質類固醇，或 IL-1 路徑抑制劑，包括 anakinra 與 rilonacept。

And all of those different transition regimens are studied and are evaluated in the study, and then go on to over a 16-week primary endpoint period. So it's really about that transition. And that then informs the label with regard to telling or informing physicians how they can make that transition. But in terms of the patient profile, it's really about the optionality for the patient and the physician to choose which effective therapy is considered to be best for them.

所有這些不同的轉換方案都會在研究中被納入並評估，接著進入超過16週的主要終點觀察期。所以重點確實在於「轉換」。而這也會為標籤內容提供依據，用以告知或指引醫師如何進行這樣的轉換。但就病患輪廓而言，核心在於讓病患與醫師有更多選擇，去決定哪一種有效療法對他們而言最合適。

And Geoff, in regards to your question on maximizing the value and cash position, I mean, I can tell you what drives us each and every day is the potential to increase that overall maximum value. There's so much kinetic energy within the company. Let's focus on that.

Geoff，關於你提到的最大化價值與現金部位，我可以告訴你，我們每天驅動我們前進的，就是提升整體最大價值的潛力。公司內部有非常強的動能。我們就聚焦在這一點。

We talked about, obviously, today the growth with ARCALYST, and we continue to be very excited about the future potential there. We talked about the latest penetration rate being, in some ways, only 23%. But equally, obviously, across the development portfolio, with KPL-387 and 1161, as we talked about, really moving now into the Phase 3 pivotal study for 387, being very excited about being in the clinic with 1161 later this year. But as you see, those latter two programs were homegrown, so we continue to look at other additional value creating opportunities, both internally but also externally. I think we've been very judicious and very thoughtful about capital allocation.

我們今天談到，顯然 ARCALYST 的成長，我們對其未來潛力仍然非常興奮。我們也提到最新的滲透率在某種程度上仍只有23%。同時，在研發產品組合方面，KPL-387 與 1161 如我們所說，387 現在正進入第三期關鍵性研究，我們也非常期待今年稍晚 1161 進入臨床。但如你所見，後面這兩個計畫都是內部自研，因此我們也持續尋找其他能創造額外價值的機會，不論是內部或外部。我認為我們在資本配置上一直非常審慎且深思熟慮。

We do look at BD opportunities. But as you can imagine, with our commercial products with our pipeline, the bar is exceedingly high. That said, we're very pragmatic, but we do look at where the value could come from all the time. It's what drives us, essentially. So rest assured, we know how to capital allocate, we know it's best to drive value, and we'll continue doing that and ultimately keep executing.

我們確實會評估 BD 機會。但你可以想像，考量到我們的商業化產品與產品線，我們的門檻非常高。即便如此，我們非常務實，也會一直尋找價值可能來自何處。這基本上就是驅動我們的核心。所以請放心，我們知道如何進行資本配置，也知道什麼最能推動價值；我們會持續這麼做，並最終持續把執行做好。

Great. Thank you.

很好。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 K. Patel, CEO, for any further remarks.

謝謝。今天節目的問答環節到此結束。我想把節目交回給執行長 Sanj K. Patel，請他做進一步的結語。

Thank you very much. Thanks everybody for dialing in today. Clearly a lot of excitement, ongoing execution, and very excited about the future. The team and I will keep driving for future success, for patients, and for creating that additional value. Thank you.

非常感謝。也謝謝大家今天撥冗參與。很明顯地，我們充滿期待、持續執行，也對未來非常興奮。我和團隊會持續推動未來的成功，為了病患，也為了創造更多額外價值。謝謝。

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、先生參與今天的會議。本節目到此結束。您現在可以掛線。祝您有美好的一天。