Kiniksa Pharmaceuticals International, PLC (KNSA) 2026 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals first-quarter 2026 earnings conference call. (Operator instruction). Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jonathan Kirshenbaum, Investor Relations. Please go ahead.

各位好，感謝您稍候。歡迎參加 Kiniksa Pharmaceuticals 2026 年第一季財報電話會議。（接線員指示）。請注意，今天的會議將被錄音。現在我想將會議交給今天的發言人——投資人關係部 Jonathan Kirshenbaum。請開始。

Thank you, operator. Good morning, everyone, and thank you for joining Kiniksa 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 Investors section.

謝謝，接線員。各位早安，感謝各位參加 Kiniksa 的電話會議，討論我們 2026 年第一季財務結果以及近期的產品組合執行情況。重點摘要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, Sanjiv k Patel, will start with an introduction. From there, Ross Moat, our Chief Operating Officer, will provide an update on ARCALYST commercial execution. Then, Kiniksa Chief Medical Officer, Dr. John Paolini, will review our KPL-387 development program and the ongoing Phase 2, Phase 3 clinical trial in recurrent pericarditis.

關於議程，我們的執行長 Sanjiv k Patel 將先做開場介紹。接著，我們的營運長 Ross Moat 將就 ARCALYST 的商業化執行提供最新進展。然後，Kiniksa 首席醫學長 John Paolini 醫師將回顧我們的 KPL-387 開發計畫，以及復發性心包炎正在進行的第 2 期／第 3 期臨床試驗。

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, for which Eban Tessari, our Chief Strategy Officer, will also be on the line.

之後，我們的財務長 Mark Ragosa 將回顧 2026 年第一季財務結果。最後，Sanj 將分享結語並啟動問答環節；屆時我們的首席策略長 Eban Tessari 也將在線上。

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.

在開始之前，請注意我們今天將發表前瞻性陳述；此類陳述受各項風險與不確定性影響，可能導致實際結果與陳述內容存在重大差異。相關陳述與風險因素的說明可見於本投影片，亦可參閱我們向美國證券交易委員會（SEC）提交文件中「風險因素」標題下的內容。

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

上述陳述僅反映本簡報日期當日的情況；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.

接下來交給 Sanj。

Thanks, Jonathan, and good day, everyone. Kiniksa continues to build spread 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.

謝謝 Jonathan，各位好。Kiniksa 持續在整體業務上累積動能，這同時來自我們在 ARCALYST 商業化方面的進展，以及我們研發管線計畫（包括 KPL-387 與 KPL-1161）的推進。

On the commercial side, the end of the first quarter marks the fifth anniversary of the FDA approval for ARCALYST 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.

在商業化方面，第一季末標誌著 ARCALYST 取得 FDA 核准用於復發性心包炎的第五週年。透過過去五年一貫且有效的執行，我們已建立並發展出這個使人衰弱的疾病市場。

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 APL-387 Phase 2, Phase 3 study in recurrent pericarditis.

這促成了患者治療典範的根本性轉變，並帶動 ARCALYST 產品線的顯著成長。在我們的臨床產品組合方面，我們持續推進 APL-387 在復發性心包炎的第 2 期／第 3 期研究。

Data on the Phase 2 dose-focusing portion of the study are on track for the second-half of this year. We also expect to start the Phase 3 portion of the program by the end of this year.

該研究第 2 期劑量聚焦部分的數據預計將於今年下半年如期公布。我們也預期在今年年底前啟動該計畫的第 3 期部分。

In addition, we are advancing KPL-1161 closer to the clinic. This is our SC-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.

此外，我們正推進 KPL-1161 更接近臨床階段。這是我們皮下注射（SC）改造的 IL-1α 與 IL-1β 抑制劑，目標產品特性為每季給藥一次。正如我們先前分享的，我們計畫在今年年底前啟動第 1 期研究。

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 five years from launch, and we intend to capture the additional opportunity that remains across the recurrent pericarditis market.

我們穩健的財務狀況，加上 ARCALYST 營收成長帶來的獲利能力，使我們能夠在整體業務中投入資源以創造價值。在商業化方面，ARCALYST 上市五年後仍維持強勁成長軌跡，我們也打算把握復發性心包炎市場中仍然存在的額外機會。

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. In the first quarter of this year, this expanding adoption contributed to ARCALYST sales growing to $214.3 million.

在美國每年約 40,000 名經歷復發性心包炎發作的患者中，使用 ARCALYST 進行長期 IL-1α 與 IL-1β 抑制治療的採用率正在擴大。今年第一季，這一採用率擴大推動 ARCALYST 銷售額成長至 2.143 億美元。

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 million to $945 million from our previous guidance of $900 million to $920 million.

展望今年其餘時間，我們在第一季觀察到處方覆蓋面與處方深度均顯著提升，為後續帶來動能。因此，我們已將 2026 全年營收指引自先前的 9.00 億至 9.20 億美元，上調至 9.30 億至 9.45 億美元。

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 programs have numerous milestones throughout the rest of the year that also have the potential to create meaningful value.

總結而言，Kiniksa 是一家資本充足、以成長為導向的公司，具備良好定位以最大化我們可取得的 ARCALYST 重大商業機會。公司產品組合計畫在今年其餘時間也有多項里程碑，具備創造可觀價值的潛力。

And now, Ross Moat.

接下來請 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 the first quarter 2025 and approximately $12 million over Q4 of last year.

謝謝你，Sanj。我們持續的商業化執行帶動第一季強勁的營收成長，使 ARCALYST 淨營收達 2.143 億美元，較 2025 年第一季增加超過 7,600 萬美元，亦較去年第四季增加約 1,200 萬美元。

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.

這項營收成長來自強勁的核心商業指標，其表現優於第一季全產業因自付額（co-pay）重置與保險方案變更所帶來的逆風。具體而言，成長主要由兩項關鍵商業動能所驅動。

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.

第一，我們看到本季新開立處方醫師的成長加速，帶動自上市以來單季新增患者註冊人數的最高增幅。

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 million to $920 million to between $930 million and $945 million.

這對今年其餘時間尤其有利，因為更大的新處方醫師基礎，加上平均治療期間的持續性，使我們得以將全年營收指引由 9.00 億至 9.20 億美元，上調至 9.30 億至 9.45 億美元。

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 Q1.

第二，第一季我們的毛額到淨額（gross-to-net）如預期較前一季上升，但低於 2025 年第一季。主要原因是我們對自付額補助計畫進行調整：我們強化了補助計畫設計，使每位患者的平均自付額補助支出相較於前一年第一季有所降低。

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.

憑藉年初所建立的動能，結合我們強勁的核心商業基礎，我們相信公司已具備良好條件在今年其餘時間持續推動 ARCALYST 成長，且未來仍有可觀機會可支持更多復發性心包炎患者。

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 launched to date.

第一季，在團隊強力執行下，約有 400 位新處方醫師首次開立 ARCALYST，創下迄今為止最高的季度環比增幅。

This brings the total number of prescribers to more than 4,550. As a reminder, with more than 25,000 health care professionals seeing recurrent pericarditis patients in a given year, there is substantial opportunity ahead. We also saw growth in the number of health care professionals who became repeat prescribers during Q1, resulting in approximately 1,320 prescribers in total who have now prescribed ARCALYST multiple times.

這使處方醫師總數提升至超過 4,550 位。提醒各位，每年約有超過 25,000 名醫療專業人員會診治復發性心包炎患者，因此未來仍有可觀機會。我們也看到第一季成為重複處方者的醫療專業人員數量增加，使目前累計約有 1,320 位處方醫師已多次開立 ARCALYST。

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.

我們在處方覆蓋面與處方深度兩方面所見到的加速，反映了我們持續的商業化執行，以及對白介素-1（interleukin-1）α 與 β 抑制作為在既往使用 NSAIDs 與秋水仙素（colchicine）之後的治療選擇之理解與採用度提升；此亦符合 2025 年 ACC《簡明臨床指引》的建議。

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 ARCALYST, with the aim of empowering them to discuss ARCALYST with their healthcare provider.

本月稍早，我們宣布啟動高度聚焦的直接面向消費者（DTC）宣傳活動「Hearts Home」。此活動旨在辨識並鎖定可能正受復發性心包炎所苦、但目前尚未使用 ARCALYST 的患者，目標是賦能他們與其醫療照護提供者討論 ARCALYST。

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

透過數位創新（包括運用 AI），我們能以具成本效益、高度精準，且最終適用於罕見疾病市場的方式來部署 BTC。

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.

我們著重於運用既有的病患資料庫，並加入搜尋最佳化與機器學習模型；這些模型以去識別化的理賠資料、人口統計與消費者市場資料為依據，用以界定一個更為富集的潛在復發性心包膜炎病患族群，以投放量身打造的內容。這與傳統 [DTC] 以大規模且高成本行銷的作法相對。

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.

我們活動的核心是一支連網電視（Connected TV）廣告，透過 YouTube、Hulu 等平台上個別使用者的串流帳戶，以及各社群媒體管道，定向投放給潛在病患。

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.

本活動以我們的市場研究為依據；研究顯示，當復發性心包膜炎病患向其醫療提供者詢問 ARCALYST 時，醫療專業人員對此詢問持開放態度，且約在 80% 的情況下會開立 ARCALYST 處方。

As previously mentioned, our ARCALYST 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.

如先前所提，我們的 ARCALYST 產品線正在成長、具獲利性，且前方仍有顯著機會。這也使我們能做出審慎的投資決策，以擴大觸及範圍、掌握機會並幫助更多病患。

With that, I'll turn the call over to John to cover our KPL-387 development program.

接下來，我把電話交給 John，請他說明我們的 KPL-387 開發計畫。

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.

謝謝你，Ross。簡要回顧一下：在設計此處所示的 KPL-387 整合式開發計畫時，我們運用了在 IL-1 訊號傳導途徑方面的豐富臨床經驗，並依開發階段加以拆分。

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.

該計畫的核心組成為第 3 期安慰劑對照、事件驅動的隨機撤藥研究。這與 Rhapsody 相同；Rhapsody 是支持 ARCALYST 於復發性心包膜炎適應症獲准的關鍵性研究。第 3 期的主要療效終點將衡量心包膜炎復發風險的降低，作為 KPL-387 在標籤適應症上療效的主要證明。

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 2 dose focusing trial and the Phase 3 pivotal trial into a single integrated Phase 2, Phase 3 protocol so that Phase 3 could initiate independently a Phase 2 execution.

根據我們與監管機關的互動，我們相信此研究足以作為單一關鍵性研究來支持註冊申請。提醒一下：為了最大化營運效率，我們將第 2 期劑量聚焦試驗與第 3 期關鍵性試驗合併為單一整合式第 2/第 3 期試驗方案，使第 3 期可在不依賴第 2 期執行進度的情況下啟動。

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 3 portion of the study by the end of this year.

此外，我們也為所有試驗活動加入長期延伸期。我們先前指引，今年下半年預期可取得此處以紅色標示之劑量聚焦研究的資料。而今天我們也指引，預期將於今年底前啟動研究的第 3 期部分。

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.

第 2 期劑量聚焦研究建立在先前 [Rilonacept] 臨床試驗的洞見之上。其設計目的在於界定 KPL-387 的 PK/PD 關係，並支持以資料驅動的方式確認第 3 期關鍵性試驗的劑量水準。

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 six-week treatment period, as well as the subsequent long-term extension through 24 weeks.

先看左側面板中的 Rilonacept 第 2 期先例。該單一有效治療組研究顯示，在初始 6 週治療期間，每週一次的 Rilonacept 透過抑制 IL-1 途徑，使活動性復發性心包膜炎且 C 反應蛋白升高的病患，其自述疼痛與發炎快速且持續下降；並在後續長期延伸期（至 24 週）仍維持此效果。

Now, looking forward, the KPL-387 Phase 2 dose focusing study, which is assessing four 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 KTL-387.

接著展望未來：KPL-387 第 2 期劑量聚焦研究將評估四個劑量水準、每組最多 20 名病患；在研究族群、每組病患數與主要終點（即治療反應時間）方面，與 Rilonacept 第 2 期研究相呼應。研究架構已依 KTL-387 長效藥物動力學的特定屬性進行調整。

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 KTL-387 dose levels, affirming that dose level for Phase 3. And informing Phase 3 outcomes measures.

因此，預期於今年下半年取得、符合開發階段所需的資料，旨在提供關於初始反應的節奏與幅度，以及 KTL-387 各劑量水準作用持續時間的有用資訊，以確認第 3 期劑量水準，並為第 3 期的結果衡量指標提供資訊。

I will now turn it over to our Chief Financial Officer, Mark.

我現在把電話交給我們的財務長 Mark。

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.

謝謝你，John。今天早上我將說明我們 2026 年第一季的財務表現。如同以往，您可在今日新聞稿中找到我們的詳細財務資訊。

In the first quarter of 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 the first quarter.

在 2026 年第一季，我們持續在整體業務上建立強勁動能，推進 ARCALYST、推動臨床產品組合進展，並維持穩健的財務狀況。從本投影片左側的損益表開始，如同您從 Sanj 與 Ross 所聽到的，第一季 ARCALYST 營收年增 56% 至 2.143 億美元。

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, increased collaboration expenses aligned with higher ARCALYST revenue and collaboration profit.

此成長主要由新開立處方醫師與新病患加入的強勁擴張所帶動，足以抵銷全產業季節性逆風的影響。營業費用年增則由多項因素驅動：因 ARCALYST 營收成長而導致的銷貨成本上升，以及與較高 ARCALYST 營收與合作利潤相一致的合作相關費用增加。

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 ARCALYST, including personnel and leveraging new technologies to enhance our targeting strategy and reach additional patients and HCPs.

研發費用增加，主要因 KPL-387 開發相關的臨床與製造成本上升；以及銷售、一般及行政（SG&A）費用增加，主要由與 ARCALYST 商業化相關的投資所驅動，包括人員配置，以及運用新技術以強化我們的精準投放策略並觸及更多病患與醫療照護專業人員（HCPs）。

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.

由於強勁的營收成長相較於較為溫和的費用成長，2026 年第一季淨利大幅增加至 2,260 萬美元，相較於 2025 年第一季的 850 萬美元。

Turning to the right-hand side of the slide, you'll find the calculation for ARCALYST collaboration profit, which drives total collaboration expenses. In the first quarter of 2026, ARCALYST collaboration profit continued to grow faster than sales on a year-over-year basis, up 73% to $151.2 million.

轉到投影片右側，您會看到 ARCALYST 合作利潤的計算方式，而該利潤驅動了合作費用總額。2026 年第一季，ARCALYST 合作利潤在年比基礎上持續以快於銷售的速度成長，上升 73% 至 1.512 億美元。

Finally, at the bottom of the slide. We ended the first quarter with a $468.1 million cash balance, representing $54 million of net cash generation for the period.

最後，在投影片底部：第一季結束時，我們的現金餘額為 4.681 億美元，代表本期間淨現金增加 5,400 萬美元。

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.

在目前的營運計畫下，我們預期以年度基礎仍將維持正向現金流，使我們能持續協助病患，同時在短期與長期創造額外價值。

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

接下來，我把電話交回 Sanj 作結語。

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.

謝謝你，Mark。如各位所聽到的，隨著我們擴大 IL-1 alpha 與 beta 抑制產品線，Kiniksa 已具備良好條件以建立可觀的未來價值。

We are dedicated to helping as many patients as possible with our office and to advancing the development of our clinical portfolio in order to bring additional therapies to patients suffering from debilitating diseases.

我們致力於透過我們的團隊盡可能幫助更多病患，並推進臨床產品組合的開發，以便為罹患致殘性疾病的病患帶來更多治療選擇。

With that, I'll now turn the call back to the operator for questions.

接下來，我把電話交回接線員進行提問。

(Operator Instructions)

（接線員指示）

Nicholas, TD Cowen.

Nicholas，TD Cowen。

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 the future, either via patients or prescriber targeting?

很好。非常感謝讓我們提問，也恭喜本季表現強勁。能否談談你們在 DTC 活動初期所觀察到的需求增加情況（也理解目前仍屬相當早期）？另外，未來你們還有哪些計畫可加速需求，不論是透過病患端或處方醫師端的精準鎖定？

Yeah. Hi, Nick. This is Ross. I'll take a pass on that. So thank you very much.

好的。嗨，Nick。我是 Ross。我來回答這題。非常感謝。

It's 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. So it's early days. One thing that I'll share with you is that.

是的，正如你所說，DTC 活動目前仍在早期。我們不久前才剛宣布，我們將以非常精準的方式聚焦 DTC，目的是去觸及我們認為可能是復發性心包膜炎的病患，並在某種程度上向他們提供資訊與教育，讓他們知道如何與其醫療照護提供者討論 ARCALYST 與復發性心包膜炎的可能性。所以目前仍是初期。我可以跟你分享的一點是：

While we also understand that when patients go in and speak to their healthcare professionals proactively about ARCLIST, it gets prescribed -- 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.

同時我們也理解，當病患主動與其醫療專業人員談到 ARCLIST 時，就會被開立處方——在約 80% 的情況下，病患會被開立 ARCALYST。另一个事實是，實際上只有約 14% 的復發性心包炎病患在沒有外力協助的情況下知道 ARCALYST。

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 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 list. So we're excited about the campaign, but as you said, it's early days.

因此我們知道病患端存在很大的認知落差。我們也知道病患分布在全國各地、非常分散。所以我們的做法是走出去，嘗試辨識這些病患，並提供適切、非常精準、非常量身打造的訊息，幫助合適的病患有能力去與其醫療專業人員討論我們的清單。因此我們對這個活動感到很振奮，但如你所說，現在仍是早期階段。

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 and as we've seen a strong growth in patients on their first recurrence as well overtime time. So the opportunity is very significant.

我們正聚焦於多項不同的計畫以加速成長。提醒一下，上次我們公布時，在 14,000 名病患族群中的滲透率約為 18%，且尚未把仍處於首次復發的病患納入；而且隨著時間推移，我們也看到首次復發病患的用藥人數同樣強勁成長。因此機會非常可觀。

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.

我們專注於在整個商業組織中持續把執行做到極致。我們也專注於數位行銷；DTC（直接面向消費者）活動是其中一部分，屬於更廣泛的數位行銷範疇。

And we also focus 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 ARCALYST on the market. So we're very excited about the future we have a multi-faceted approach to how we're going to continue to grow the breadth and the depth of prescribing and help more and more patients.

我們也著重於同儕對同儕（peer-to-peer）的教育，並推動治療復發性心包炎病患的這一波新方式；在 ARCALYST 過去五年於市場可得之後，這個領域確實發生了很大的轉變。因此我們對未來非常期待；我們採取多面向的方法，持續擴大處方的廣度與深度，並幫助越來越多的病患。

Anupam Rama, JPMorgan.

Anupam Rama，摩根大通（JPMorgan）。

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 2, how do you think about which ones are most important in sort of the ultimate dose selection, moving to Phase 3?

關於 KPL-387 以及下半年劑量聚焦的更新，John，我想請你評論一下：當你看 Phase 2 將要評估的各項終點與評估指標的整體範圍時，你如何判斷哪些在最終劑量選擇、以及推進到 Phase 3 時最重要？

Good morning, Anupam, and thank you for that question. Yes, so with regard to the Phase 2 trial, which is currently ongoing, the value.

早安，Anupam，謝謝你的問題。是的，關於目前仍在進行中的 Phase 2 試驗，其價值。

I think, of Slide 13 is that it shows you what kind of we had generated in the past in the Phase 2 program with Rilonacept 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-reactor protein.

我認為第 13 張投影片的重點在於，它向你展示了我們過去在 Rilonacept 的 Phase 2 計畫中所產生的內容，涵蓋三個關鍵要素：當然就是我們所稱的節奏與幅度（cadence and magnitude），基本上指的是起效時間，以及對疼痛與發炎（以 C 反應蛋白衡量）的抑制程度。

And then the additional element of durability of response. And that's what we showed previously with Rilonacept, and so carrying that forward to the KPL-387 program.

接著還有反應持久性（durability of response）這個額外要素。這些是我們先前用 Rilonacept 所展示的，因此也把這些概念延伸到 KPL-387 計畫。

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.

同樣地，針對 KPL-387 的初始劑量，我們在模型中顯示，不論選擇哪個劑量水準，我們預期都會看到較高的藥物濃度；模型推估這將帶來快速的起效節奏，以及在抑制初始發炎反應方面的效果幅度。

And then the additional scientific question that we intend to glean by looking at the different dose levels, is that. Of action of the four different dose levels that we take forward, that we look at in the trial. And then from that, we integrate all three 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. So it's really the integration of those three critical elements.

接著我們希望透過觀察不同劑量水準來釐清的另一個科學問題是：在試驗中我們將推進並評估的四個不同劑量水準，其作用表現。然後我們會整合這三個要素，建立 PK/PD 關係，並確認我們所認為的治療性濃度，以及我們將帶入 Phase 3 的劑量水準。因此，核心就是把這三個關鍵要素加以整合。

David Nierengarten, Wedbush Securities.

David Nierengarten，Wedbush Securities。

Hey, thanks for taking the question. Just a couple of quick ones from 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? 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 Phase 1 or Phase 2, is there any reason you picked.

嗨，謝謝讓我提問。我這邊有兩個很快的問題。第一，關於 DTC 廣告：把行銷費用的年增量視為 DTC 這個組成部分，這樣建模是否合理？還是其中還包含你們新增聘的業務人員或其他人員、或其他費用？第二個問題關於 387：在轉換研究中，治療期間是 16 週，這與你們在 Phase 1 或 Phase 2 看過的 12 或 24 週不同；你們選擇 16 週而不是做一個更「蘋果對蘋果」的療程長度比較（至少對於從 ARCALYST 轉到 387 的病患）是否有特別原因？

16 weeks versus, having a little bit more apples-to-apples duration comparison at least for patients who are moving from ARCALYST , 387.

16 週相較於——在療程長度上做更接近的對照，至少對於從 ARCALYST 轉到 387 的病患而言。

Thanks Maybe David on the 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 initiatives, which Ross 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.

謝謝。也許我先回應第一個問題，David。我的意思是，我想你在電話會議中也聽到我們提到，SG&A 的確因為人員相關費用，以及銷售與行銷計畫而上升，Ross 也已經談到一些。我們會持續以負責任的方式投資 ARCALYST 的商業化；從合作利潤持續比營收成長更快也可看出這點。

And so I think as 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.

因此，雖然我們並未對支出提供指引，但我認為值得注意的是，以銷售額百分比來看，SG&A 在過去一年相當一致。

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. This study is really designed to look at well-controlled patients as they move from their prior therapies to KPL-387.

接著關於你的問題，David，謝謝你詢問關於轉換到 KPL-387 單一療法（monotherapy）的給藥與用法研究。是的，該研究中用法用量（posology）部分的 16 週治療期間，確實適合這類研究。這項研究的設計主要是觀察控制良好的病患，如何從既有治療轉換到 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 Rilonacept. And so what we had seen previously with regard to Rilonacept was a time to monotherapy of under eight weeks in the RHAPSODY program. And so, this program is designed to basically move patients off of those other therapies onto KPL-387.

在這項研究中，病患將從 NSAIDs 與秋水仙素（colchicine）的治療方案、從皮質類固醇（corticosteroids），以及從 IL-1 路徑抑制劑（包括 anakinra 與 Rilonacept）等方案進行轉換。就 Rilonacept 而言，我們先前在 RHAPSODY 計畫中看到，達到單一療法的時間少於 8 週。因此，這個計畫的目的基本上是讓病患從那些其他治療轉到 KPL-387。

And achieve monotherapy within that time window. 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. So it's a well-designed study to inform that element of the label, if you will, of clinical practice for transitioning patients to KPL-387.

並在該時間窗內達成單一療法。然後，當然還會給予額外劑量，以在第 16 週時間點達到穩態（steady state）。但更重要的是，病患之後會轉入長期延伸期（long-term extension），可持續接受 KPL-387，總計最長可達兩年。因此，這是一項設計良好的研究，用以提供（如果你願意這麼說）標籤內容中、臨床實務上病患轉換到 KPL-387 的那個面向之資訊。

Maybe a quick follow-up. Obviously, you'll look at the patients by prior treatment to determine if anyone has a new attack of pericarditis.

也許再追問一下。顯然你們會依病患先前的治療來觀察是否有人出現新的心包炎發作。

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?

當然你們會知道他們先前使用的是哪種治療，並據此分層。那麼你們對於轉換時先前治療差異的考量是什麼？

So that's a very reasonable statement. And if you look at, for example, the ARCALYST label, it covers all of the different therapies that patients can transition from. So it talks about NSAIDs and colchicine. It talks about corticosteroids.

這個說法非常合理。舉例來說，如果你看 ARCALYST 的標籤，它涵蓋了病患可從哪些不同治療進行轉換，包括 NSAIDs 與秋水仙素，也包括皮質類固醇。

And then we didn't do this study specifically for recurrent pericarditis for anakinra because that had already been done for [DIRA]. 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.

而且我們並未針對復發性心包炎特別為 anakinra 做這項研究，因為那在 [DIRA] 已經做過了。因此我們在那項試驗中所報告的是：病患在不同治療下的反應，以及達到單一療法的時間。同樣地，在這項試驗中，當然你會檢視病患原先來自的各種不同給藥方案，並確認轉換到 KPL-387 的結果是穩健的。

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

重要的是要指出，起始期——也就是在我們預期的第三期（Phase 3）劑量水準下，KPL-387 的作用持續時間會更長。每月給藥可涵蓋大部分初始轉換期，具體取決於治療方案。

Edward Nash, Canaccord Genuity.

Edward Nash，Canaccord Genuity。

So I wanted to ask, I know, obviously, the DTC program is relatively new and I just wanted to kind of understand with regards to what's driving the biggest change in new patient starts.

所以我想請教一下，我知道很明顯 DTC 計畫相對較新，我只是想大致了解一下，究竟是什麼在推動新病患開始用藥方面最大的變化。

You said that on awareness, the awareness gap has shrunk and that you've seen increasing physician adoption. What effect has reimbursement or referral patterns had into this new patient starts?

你提到在認知度方面，認知落差已縮小，而且你們看到醫師採用度在提升。那麼，給付（reimbursement）或轉介（referral）模式對這些新病患開始用藥有什麼影響？

Thanks, Ed. I appreciate your question. So yes, there are lots of different things driving the increases that we've seen, not just in Q1, but overtime time as well. But of note, Q1 was the highest ever quarter-on-quarter growth that we've had in terms of new prescribers.

謝謝你，Ed。我很感謝你的問題。是的，確實有很多不同因素在推動我們看到的成長，不僅是在第一季（Q1），長期以來也是如此。不過值得注意的是，第一季是我們在新開立處方醫師（new prescribers）方面，歷來最高的季對季成長。

It was also the highest ever since the time of our launch, five years ago, the highest ever number of new patient enrollments or new prescriptions coming in for ARCALYST. So clearly, we're at a stage five years out from our launch where we're growing very nicely with a substantial opportunity ahead.

同時，這也是自我們五年前上市以來，ARACLYST 新病患註冊或新處方進件數量的歷史新高。因此很明顯，我們在上市五年後正處於非常良好的成長階段，且前方仍有相當可觀的機會。

The reimbursement continues to be very strong across all the different payer mixes and that's both new patients coming on as well as the revalidation of the scripts, usually after a one-year time period. So that continues to really be very positive.

在各種不同的付款方組合（payer mixes）中，給付情況仍然非常強勁，這包括新病患加入，以及通常在一年期後對處方進行再驗證（revalidation）。因此這點持續非常正面。

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.

就轉介而言，我認為確實有一些中心——大約 18 個中心——可視為卓越中心（centers of excellence），或是專門的心包疾病門診（pericardial disease-specific clinics）。它們部分是在一個計畫下被認可，也就是 AHA 的「addressing recurrent pericarditis」計畫，而我們是該計畫的贊助者之一。

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, but it also remains the case that recurrent pericarditis patients are broadly dispersed across the country.

我認為這是一項有幫助的倡議，能在這 18 個團體之間，隨時間推進，提升並分享如何診斷與治療復發性心包膜炎（recurrent pericarditis）的專業能力；但同時也仍然是這樣的情況：復發性心包膜炎病患在全國各地分布相當分散。

We have to touch 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.

我們必須在全國各地觸及許多接觸點，才能教育醫師。我們著重於同儕對同儕（peer-to-peer）的教育來達成這點，當然也包括我們的業務團隊，以及像新的 DTC 活動這類的數位行銷倡議，我們對此感到很振奮。

But as I mentioned earlier, 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 many patients go through multiple physicians and 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.

但如我先前提到的，只有約 14% 罹患復發性心包膜炎的病患，在沒有提示的情況下就知道 ARACLYST（unaided awareness）。因此，將主導權交到病患手中、讓病患更了解自身疾病——並且承認許多病患在得到復發性心包膜炎診斷前，會經歷多位醫師與多次誤診——我們認為這能在提升認知度方面扮演重要角色，並賦能病患去向醫師詢問復發性心包膜炎、詢問 ARACLYST，以及最終……

Could play one of the roles amongst many things that we're doing in continuing to seize the opportunity that we have ahead.

可能會在我們持續把握前方機會的眾多作為中，扮演其中一個角色。

Paul Choi, Goldman Sachs.

Paul Choi，Goldman Sachs。

I was wondering, first, if you could maybe elaborate a little bit more on the co-payment commentary for the quarter is this going to be something just specific to this particular quarter or could it be more potentially structurally favorable to gross to net over the long-term?

我想先請問，你是否可以再多闡述一下本季關於自付額（co-payment）的評論：這會只是本季特有的情況，還是可能在長期結構性地對毛額到淨額（gross to net）更有利？

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 III, or are you still testing multiple doses there?

第二個問題是關於 KPL-387，主要是轉換（transition）方面、目前進行中的切換研究（switch study）。你能否評論一下，這是否意味著你們對第三期（Phase III）後續劑量有相當高的信心，還是仍在測試多個劑量？

I might take the first question.

我先回答第一個問題。

So, I think. Paul, we haven't provided specific guidance on gross to net. So we still do not expect major fluctuations relative to 2025, but we do anticipate now the co-pay support will be favorable to gross to net on an annual basis with the majority of the impact having taken place in the first quarter.

所以，我認為……Paul，我們尚未就毛額到淨額（gross to net）提供具體指引。因此，相較於 2025 年，我們仍不預期會有重大波動；但我們現在預期，自付額補助（co-pay support）在年度基礎上將對毛額到淨額更有利，而且大部分影響已在第一季發生。

And I think as we sort of take a look at gross 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 gross 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.

而且當我們檢視全年毛額到淨額的走勢時，我會重申我們之前說過的：在不考慮任何前期準備金（reserve）調整的情況下，我們預期毛到淨在第一季最高，第二、第三季會走低，然後第四季會因產業動態再次開始發揮影響而回升。

I don't know if there's components to the co-pay that you want to discuss further than that, but at least that's the impact on gross to net.

我不確定你是否還想進一步討論自付額的其他組成，但至少這就是對毛額到淨額的影響。

Yes, that's right. Mark, thank you for that. I'll just maybe add a little bit more flavor onto the co-pay dynamics, Paul. So we did make enhancements to our co-pay assistance program at the beginning of this year, which ultimately reduced the average co-pay payment per patient.

是的，沒錯。Mark，謝謝你。我再補充一點自付額動態的細節，Paul。今年年初我們強化了自付額補助計畫，最終降低了每位病患的平均自付額支付金額。

And subsequently, had the knock-on effect to the more favorable gross to net versus Q1 of last year, albeit higher than Q4 of last year. And that's driven by a couple of things, firstly, reducing the maximum amount of co-pay payments that we make per patient.

隨後也產生連帶效應，使得毛額到淨額相較去年第一季更為有利，儘管仍高於去年第四季。這主要由幾個因素驅動：第一，降低我們對每位病患支付自付額的最高金額上限。

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 companies pick up on it.

第二，我們也導入機器學習解決方案，主動辨識採用非傳統支付方案（non-traditional payment plans）的病患，例如 maximizer plans，以便能夠鎖定這些病患。你可能知道，許多這類方案的設計，是在保險公司開始承擔之前，先把成本盡可能轉嫁給製藥商，直到補助資金耗盡為止。

So by lowering that co-pay 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. So that had to knock on, in fact, into the gross to net. So thank you for the question, Paul.

因此，對於這些非傳統方案降低自付額金額後，就降低了在病患獲得其保險人全額給付之前，我們對每位病患支付的最高金額。這確實對毛額到淨額產生了連帶影響。謝謝你的問題，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. 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. So, we will have more to say at a later date about the design of the study.

謝謝你關於轉換至單一療法（monotherapy）研究的問題。我們目前已分享的研究設計細節可在 clinicaltrials.gov 查到。你會在那裡看到研究的整體架構，但公開資訊並未包含將研究的劑量水準——是單一劑量水準或多個劑量水準——的具體資訊。因此，我們會在稍後就研究設計提供更多說明。

Jeff [Meacham], Citi.

Jeff [Meacham]，Citi。

Just had two quick ones. Ross, on the commercial side, is there a tipping point for adding more patients 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 more upstream segment?

我有兩個簡短問題。Ross，在商業端方面，是否存在一個臨界點（tipping point），讓你們會把更多病患納入第一次復發（first recurrent）族群？我不確定你們是否想再多等一段時間，觀察認知度與 DTC 能見度？或者你們覺得在更上游的族群中，可能需要處理給付方面的障礙？

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. Would you want to be in the Phase 3 for [3.87] before you take another look at BD? I wasn't starting to think about it.

第二個問題給 Sanj：在正向現金流與穩定獲利的情況下，你們如何思考從現在開始最大化價值？你們會希望在進入 [3.87] 的第三期（Phase 3）之前，再重新評估一次 BD（商務開發）嗎？我只是開始在想這件事。

Thanks very much, Jeff. I appreciate the question. So yes, as mentioned earlier, we were at the last reported, we were around 18% penetrated into the 2-plus recurrence group. About 20% of prescriptions that we have now are in the first recurrence group that's grown overtime. We think the 2025 ACC concise clinical guidance is also helpful towards that as it places the use of IL-1 inhibition.

非常感謝你，Jeff。我很感謝這個問題。是的，如先前提到，在上次揭露時，我們在 2 次以上復發（2-plus recurrence）族群的滲透率約為 18%。我們目前約有 20% 的處方來自第一次復發族群，且隨時間推移有所成長。我們認為 2025 年 ACC 的簡明臨床指引（concise clinical guidance）也有助於此，因為它將 IL-1 抑制（IL-1 inhibition）的使用……

Prior to the use of corticosteroids, so moving ARCALYST further upstream, if you like, earlier on in the disease. So we think those things are all important and acknowledging that ARCALYST really has a very broad label, which is agnostic to the number of flares that a patient has suffered.

在使用皮質類固醇之前，因此如果你願意的話，將 ARCALYST 更往上游推進，也就是在疾病更早期使用。因此，我們認為這些因素都很重要，同時也要認知到 ARCALYST 的核准適應症標示其實非常廣泛，並不取決於患者曾經經歷的發作次數。

And we have broad patient coverage 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 when you take those metrics around the two-plus recurrences and the first recurrence group.

而且就大多數保險計畫而言，我們在核准適應症範圍內確實擁有廣泛的患者給付覆蓋。因此我們在這方面處於相當不錯的狀態；這也是為什麼當你把「兩次以上復發」以及「首次復發」族群的那些指標納入考量時，我們仍然認為未來的機會非常可觀。

Jeff, this is San. Thanks for the question as well. As for many years, this team is very much focused on creating value.

Jeff，我是 San。也謝謝你的提問。多年來，這個團隊一直非常專注於創造價值。

And we also know how to execute, so to your point on 387, clearly there's a lot of focus right now on getting through this Phase 2 study, having to get in the second-half of this year and starting our Phase 3 study this year, which I think is very exciting.

我們也知道如何落地執行，所以回到你提到的 387，很明顯目前有大量重點放在完成這項第 2 期研究、在今年下半年取得結果，並在今年啟動我們的第 3 期研究，我認為這非常令人振奮。

Clearly, we're very much focused on capturing further growth of our list, very important. Continued effort for us, but then, as you said, 1161 also should enter the clinic this year, 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 can certainly look at BD opportunities.

很明顯，我們也非常專注於持續推動我們產品名單的進一步成長，這非常重要，對我們而言也是持續的努力；同時，如你所說，1161 也應該會在今年進入臨床，因此對我們來說有多個里程碑。我們會持續在各項工作之間取得平衡，並評估是否還有其他創造價值的方法；而且如你所說，我們當然也可以評估 BD（商務開發）機會。

We have a very high bar though, and so we try to stay as pragmatic as possible, looking at all the value both internal creators, the creation from internal value drivers, but also looking at business development, so we can continue to do that.

不過我們的門檻非常高，因此我們會盡可能務實，從內部價值創造者、內部價值驅動因素所帶來的價值創造來看，同時也會評估商務開發，並持續這麼做。

But capital allocation is very important to us. Being efficient is very important to us. We've done that very nicely, 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 inflation all the time and balance it well going forward.

但資本配置對我們非常重要，效率對我們也非常重要。我認為我們透過這項數位 DTC（直接面向消費者）努力，以及運用 AI 的方式來非常高效率地推進，做得相當不錯。所以請相信我們：我們會一直把價值提升放在心上，並在未來持續做好平衡。

Roger Song, Jefferies.

Roger Song，Jefferies。

Hi, good morning, team. This is Fiona off of Roger. Congrats on the strong quarter and thanks for taking our question. Maybe just a quick one on KPL-387. Any meaningful difference in terms of formulation versus ARCALYST and do you plan to use an auto-injector?

大家早安，團隊好。我是 Fiona，代 Roger 發言。恭喜本季表現強勁，也謝謝你們回答我們的問題。想先快速問一個關於 KPL-387 的問題：在製劑方面相較於 ARCALYST 是否有任何實質差異？你們是否計畫使用自動注射器？

And maybe just down the line, if 387 gets improved, how do you plan your commercial strategy around incorporating to potentially transition to 387?

另外再往後看，如果 387 獲得改善（或更佳表現），你們在商業策略上會如何規劃，把它納入並可能逐步轉換到 387？

Yes. 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 Sans with regard to next steps. So, yes, there is a difference with regard to KPL-387 in that it is a liquid formulation.

好的，謝謝這個問題。我先就分子的生物物理特性做一些說明，先鋪陳一下背景，接著再把後續步驟交給 Sans。是的，KPL-387 的確有差異，因為它是液體製劑。

And so that liquid formulation allows for the total dose, if you will, of KPL-387 to be delivered in a single syringe. And we anticipate that with the extended pharmacokinetics, which we've shown previously in Phase 1, 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. And we have not discussed that in detail at this time. But I'll turn it over to Sanj.

而這種液體製劑使得 KPL-387 的總劑量可以在單一注射器中完成給藥。我們預期，基於我們先前在第 1 期已展示的延長藥物動力學特性，這將支持每月一次給藥。一旦具備這樣的特性，就會形成一個相當有利於開發自動注射器的情境。我們目前尚未就此進行詳細討論。接下來交給 Sanj。

Yeah, 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 at phase three this year, obviously entering more one to one, but nothing else to add. And we plan to do them as fast as humanly possible and as well as humanly possible.

是的，沒有什麼要補充的。很明顯，我們會持續推進正在進行的臨床試驗；我們今天也談到了這些，第 2 期、第 3 期研究，今年啟動第 3 期，顯然會更一對一地推進，但沒有其他要補充。我們計畫以人力所及的最快速度、也以人力所及的最佳品質來完成。

Eva Fortea, Wells Fargo.

Eva Fortea，Wells Fargo。

Hey, good morning. Congrats on the quarter and thanks for taking our questions. Two quick ones from us. How should we be thinking about R&D expense for the rest of the year and into 2027 as 387 Phase 3 and 1161 Phase 1 are initiated?

嗨，早安。恭喜本季表現，也謝謝你們回答我們的問題。我們有兩個簡短問題：隨著 387 第 3 期與 1161 第 1 期啟動，對於今年剩餘時間以及到 2027 年的研發費用，你們建議我們應該如何看待？

And the second question is, you've guided to initiating the Phase 3 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 2 data before moving forward? Thanks.

第二個問題是，你們指引在 26 年底前啟動 387 的第 3 期關鍵性（pivotal）部分。要啟動該研究是否需要先完成任何關鍵步驟或里程碑，還是只是等看到第 2 期數據後再往前推進？謝謝。

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, 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.

謝謝你，Eva。先回應研發的問題，和先前一個問題類似，我們沒有提供明確的指引；但即便如此，我認為以銷售額百分比來看，過去一年研發費用相當一致。就研發而言，關鍵變數主要是臨床試驗的時程，以及臨床用藥供應的製造。

And so we've disclosed several ongoing investments that we plan to further advance in 2026, including the development of 387 into Phase 3 and KPL-1161 into Phase 1. 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.

因此，我們已揭露數項正在進行的投資，並計畫在 2026 年進一步推進，包括將 387 推進至第 3 期，以及將 KPL-1161 推進至第 1 期。當然，試驗進行時間越長，通常成本會略為增加；但我認為，把銷售成長的表現，以及我們過去一年研發費用相對銷售額維持相當一致的情況放在脈絡中理解，是一個重要的指標。

And then, Eva, thank you for your question with regard to the Phase 2, Phase 3 transition. So with Phase 2 data expected in the second-half of 2026, we're on track for receiving dose level confirmation data in that time framework. And because the Phase 2 dose focusing portion and the Phase 3 pivotal portion have been integrated into a single Phase 2, Phase 3 protocol, the Phase 3 pivotal trial can begin independently of Phase 2 execution.

另外，Eva，謝謝你關於第 2 期到第 3 期轉換的問題。由於預期在 2026 年下半年取得第 2 期數據，我們正按計畫在該時間範圍內獲得劑量層級確認數據。並且因為第 2 期的劑量聚焦部分與第 3 期的關鍵性部分已整合在同一份第 2/第 3 期試驗方案中，第 3 期關鍵性試驗可以不依賴第 2 期的執行而獨立開始。

And I'm not showing any further questions at this time. I'd like to turn the call back over to Saj for any further remarks.

目前我這邊沒有看到其他問題。我想把電話會議交回給 Saj，請他做最後補充。

Thanks, operator. Thank you for all the questions and joining the call today. We look forward to the moment of the year and, of course, providing additional updates in the future.

謝謝，接線員。也謝謝大家今天的提問並參與本次電話會議。我們期待今年接下來的進展，當然也會在未來提供更多更新。

Thank you.

謝謝。

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.

謝謝各位女士、先生。今天的簡報到此結束。感謝各位的參與。您現在可以掛線，祝您有美好的一天。