英賽德 (INCY) 2026 Q1 法說會逐字稿

Greetings, and welcome to the Incyte first quarter 2026 earnings conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded. (Operator Instructions)

各位好，歡迎參加 Incyte 2026 年第一季財報電話會議與網路直播。（接線員指示）提醒各位，本次會議將被錄音。（接線員指示）

It’s now my pleasure to turn the call over to Alexis Smith, Vice President, Head of Investor Relations. Please go ahead, Alexis.

現在我很榮幸將電話交給投資人關係部副總裁暨主管 Alexis Smith。Alexis，請開始。

Thank you. Good morning. Welcome to Incyte’s first quarter 2026 earnings conference call. Before we begin, I encourage everyone to go to the investors section of our website to find the press release, related financial tables, and slides that follow today’s discussion.

謝謝。各位早安。歡迎參加 Incyte 2026 年第一季財報電話會議。在開始之前，我鼓勵大家前往我們網站的投資人專區，查閱新聞稿、相關財務表格，以及配合今天討論的簡報投影片。

On today’s call, I am joined by Bill, Pablo, and Tom, who will deliver our prepared remarks. Steven, Dave, and Mohamed will also be available for the Q&A portion of today’s call. I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and, our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail.

今天的電話會議中，我與 Bill、Pablo 及 Tom 一同出席，他們將發表我們事先準備的談話。Steven、Dave 與 Mohamed 也將在今天的問答環節提供回應。我想提醒各位，我們將發表前瞻性陳述，係基於我們目前的預期與信念。這些陳述受特定風險與不確定性影響，我們的實際結果可能會有重大差異。我鼓勵各位參閱我們向 SEC 提交文件中所討論的風險因素，以取得更多細節。

I will now hand the call over to Bill.

接下來我把電話交給 Bill。

Thank you, Alexis, and good morning, everyone. We're off to a strong start in 2026 with net sales up 20% year-over-year, driven by strong demand across our entire portfolio. In parallel, we advanced the pipeline with key regulatory and clinical milestones.

謝謝你，Alexis，各位早安。2026 年我們開局強勁，淨銷售額年增 20%，主要受惠於我們整體產品組合的強勁需求。同時，我們也在法規與臨床的重要里程碑上推進了研發管線。

We view '26 as a year of strategic progress as we transition Incyte beyond a single cornerstone product toward a high-quality, growth-oriented portfolio across hematology, oncology and immunology.

我們將 2026 年視為策略性進展的一年，因為我們正推動 Incyte 從單一核心產品，轉型為橫跨血液學、腫瘤學與免疫學的高品質、以成長為導向的產品組合。

This progress will come from multiple sources, the continued organic growth from our commercial portfolio, the execution of life cycle launches of key brands, the advancement of a broad increasingly late-stage pipeline and a focused approach to business development.

這些進展將來自多個來源：商業化產品組合的持續內生成長、關鍵品牌的生命週期上市執行、廣泛且日益進入後期階段的研發管線推進，以及聚焦的商務開發策略。

The sequencing and pace of execution here matters as these efforts are intended to lay the foundation for a future beyond Jakafi. During the quarter, the FDA accepted our regulatory application for povorcitinib in patients with moderate to severe HS.

在此，執行的先後順序與速度至關重要，因為這些努力旨在為 Jakafi 之後的未來奠定基礎。本季期間，FDA 已受理我們針對 povorcitinib 用於中度至重度 HS（化膿性汗腺炎）患者的法規申請。

The application was submitted ahead of schedule and is supported by a robust high-quality data set across both pre- and post-biologic patient populations.

該申請較原定時程提前提交，並由一套強健且高品質的資料集支持，涵蓋生物製劑治療前與治療後的患者族群。

If approved, we believe povo should be a significant growth driver for Incyte as the first FDA-approved oral anti-inflammatory treatment for HS, a disease which affects more than 300,000 people in the United States.

若獲核准，我們相信 povo 將成為 Incyte 重要的成長驅動力，作為首個獲 FDA 核准用於 HS 的口服抗發炎治療；HS 在美國影響超過 30 萬人。

We also remain on track for several regulatory decisions this year, including Jakafi XR, which has the potential to generate meaningful sales and serve as an important sales bridge and Opzelura for moderate atopic dermatitis in Europe, a key future growth opportunity for the brand and our international business.

我們也仍按計畫在今年迎來多項法規決定，包括 Jakafi XR；其有望帶來可觀銷售，並作為重要的銷售橋接。同時，Opzelura 用於中度異位性皮膚炎在歐洲的核准，將是該品牌及我們國際業務未來成長的關鍵機會。

Finally, we expect global submissions from Monjuvi in the first-line DLBCL in the first half of the year with approval and launch anticipated in early 2027. Across the pipeline, we continue to advance novel compounds that support our broader transition to a hem/onc I&I company.

最後，我們預期今年上半年將就 Monjuvi 用於一線 DLBCL（瀰漫性大 B 細胞淋巴瘤）進行全球送件，並預計於 2027 年初核准並上市。就整體研發管線而言，我們持續推進新型化合物，以支持我們更廣泛地轉型為血液／腫瘤與免疫炎症（I&I）公司。

The pipeline reflects a deliberate balance of risk and reward, combining programs with the potential for outsized returns alongside opportunities that can deliver incremental but highly reliable growth. This work is backed by an experienced clinical development and clinical operations team and consistent execution across trials.

研發管線反映了我們在風險與報酬之間的審慎平衡：一方面結合具備超額回報潛力的計畫，另一方面也納入可帶來增量但高度可靠成長的機會。這項工作由經驗豐富的臨床開發與臨床營運團隊支撐，並在各項試驗中維持一致的執行力。

In hematology, we had a positive end of phase meeting with the FDA in the first quarter and are on track to initiate our Phase 3 study evaluating our mutant CALR antibody 989 in previously treated CALR positive patients with ET by midyear.

在血液學方面，我們於第一季與 FDA 進行了正向的第二期結束（End-of-Phase）會議，並按計畫於年中啟動第三期研究，評估我們的突變型 CALR 抗體 989，用於先前已治療之 CALR 陽性 ET（原發性血小板增多症）患者。

This represents an important step as we continue to build a portfolio of molecularly targeted therapies, which Pablo will discuss in more detail shortly. In oncology, we now have four pivotal trials underway across colorectal, ovarian and pancreatic cancers, including the recent initiation of our G12D program in first-line pancreatic cancer earlier this month.

這代表我們持續建立分子標靶治療產品組合的重要一步，Pablo 稍後將更詳細說明。在腫瘤學方面，我們目前已有四項關鍵性（pivotal）試驗在結直腸癌、卵巢癌與胰臟癌領域進行中，其中包括本月稍早剛啟動的 G12D 計畫，針對一線胰臟癌。

These programs target areas of significant unmet need and represent meaningful long-term growth opportunities for the company. In immunology, we are advancing registrational programs in mild to moderate HS for Opzelura and moderate to severe HS, vitiligo and PN for povorcitinib.

這些計畫鎖定高度未被滿足的醫療需求領域，並代表公司具意義的長期成長機會。在免疫學方面，我們正推進 Opzelura 用於輕至中度 HS 的註冊性計畫，以及 povorcitinib 用於中度至重度 HS、白斑症與 PN（結節性癢疹）的註冊性計畫。

In addition to the regulatory acceptance for povo in HS mentioned earlier, today, we announced positive results from both Phase 3 registrational studies in adults with nonsegmental vitiligo. These results will support a regulatory application in nonsegmental vitiligo expected in the first half of 2027.

除了先前提到 povo 用於 HS 的法規受理之外，我們今天也公布兩項第三期註冊性研究在成人非節段型白斑症中的正面結果。這些結果將支持我們預計於 2027 年上半年提出非節段型白斑症的法規申請。

Over time, we believe the I&I portfolio at Incyte has the potential to become a significant contributor to the business, representing approximately 1/3 of total revenue by 2030. Finally, I want to take a moment to talk about management. At this stage of the company, our results depend largely on the strength of our management team.

隨著時間推進，我們相信 Incyte 的 I&I 產品組合有潛力成為業務的重要貢獻者，至 2030 年約可占總營收的三分之一。最後，我想花點時間談談管理層。在公司現階段，我們的成果很大程度取決於管理團隊的實力。

Experience, judgment, decision-making and the ability to execute strategic plans. With that context, we have made several executive appointments. This morning, we announced the appointment of Suky Upadhyay as Chief Financial Officer.

包括經驗、判斷力、決策能力，以及執行策略計畫的能力。在此背景下，我們已做出數項高階主管任命。今天早上，我們宣布任命 Suky Upadhyay 擔任財務長（CFO）。

Suky brings deep experience leading large finance organizations, most recently Zimmer Biomet and Bristol-Myers Squibb. We also announced the appointment of Pablo Cagnoni as President, Incyte and Global Head of Research and Development; and Steven Stein as Executive Vice President and Chief Medical Officer and Head of Late-stage Development.

Suky 擁有領導大型財務組織的深厚經驗，最近任職於 Zimmer Biomet 與 Bristol-Myers Squibb。我們也宣布任命 Pablo Cagnoni 擔任 Incyte 總裁暨全球研發主管；以及 Steven Stein 擔任執行副總裁、首席醫療長暨後期開發主管。

Additionally, Mohamed Issa was appointed as Executive Vice President and Head of US Commercial, coinciding with the integration of our US commercial operations into a single organization. Mohamed is an experienced executive with a track record of new product launch planning and operations.

此外，Mohamed Issa 獲任命為執行副總裁暨美國商業化主管，並配合我們將美國商業化營運整合為單一組織。Mohamed 是一位經驗豐富的主管，在新產品上市規劃與營運方面有良好實績。

The new structure is intended to establish consistent standards and enterprise-level capabilities across analytics, market access, sales operations and patient services, creating a launch-ready organization in 2026.

新的架構旨在於分析、通路與給付（market access）、銷售營運與病患服務等領域建立一致標準與企業級能力，打造 2026 年具備上市準備度的組織。

These capabilities can be leveraged across the portfolio to maximize the return on our commercial investments. Taken together, these appointments give us the management experience and operational oversight for the next phase of the company.

這些能力可在整體產品組合中加以運用，以最大化我們商業化投資的報酬。綜合而言，這些任命為公司下一階段提供了所需的管理經驗與營運監督。

Now turning to the quarter. Total revenue in the first quarter of '26 was $1.27 billion, up 21% over prior year. Net sales in the first quarter totaled $1.1 billion, representing 20% growth year-over-year.

接著談本季表現。2026 年第一季總營收為 12.7 億美元，較去年同期成長 21%。第一季淨銷售額合計 11 億美元，年增 20%。

Sales increased for every marketed product, both in the United States and internationally, and was driven by strong prescription and volume demand across the portfolio. Jakafi sales in the first quarter were $758 million, up 7% year-over-year.

所有已上市產品的銷售在美國與國際市場皆有所成長，主要由整體產品組合強勁的處方量與出貨量需求所帶動。Jakafi 第一季銷售額為 7.58 億美元，年增 7%。

Prescription demand increased 6% with broad-based growth across all indications, MF, PV and GVHD. New patient starts remain strong. The prescriber base is stable and a formulary coverage is broad, providing an important foundation for the Jakafi XR launch.

處方需求成長 6%，在所有適應症（MF、PV 與 GVHD）均呈現廣泛成長。新病患起始治療人數仍然強勁。開立處方的醫師基礎穩定，且給付名冊（formulary）涵蓋廣泛，為 Jakafi XR 上市提供重要基礎。

We anticipate the approval and launch of XR in the middle of the year. Our immediate focus will be on securing adequate formulary coverage for XR over the next 12 months post launch. We estimate that XR can achieve 10% to 30% of Jakafi's business by 2029.

我們預期 XR 將於年中獲核准並上市。我們當前的重點是在上市後 12 個月內，為 XR 爭取足夠的給付名冊涵蓋。我們估計到 2029 年，XR 可達到 Jakafi 業務的 10% 至 30%。

We'll provide more insights on the launch in future quarters. Sales for our core business, excluding Jakafi, were up 63% year-over-year, with contributions across hematology, oncology and immunology.

我們將在未來幾季提供更多關於上市的洞見。我們的核心業務（不含 Jakafi）銷售年增 63%，在血液學、腫瘤學與免疫學領域皆有貢獻。

This business will be supported by four new product launches over the next 12 months including Jakafi XR, Opzelura for moderate AD dermatitis in Europe, Monjuvi in first-line DLBCL and povorcitinib in HS.

未來 12 個月內，該業務將由四項新產品上市所支持，包括 Jakafi XR、Opzelura 用於歐洲中度 AD（異位性皮膚炎）、Monjuvi 用於一線 DLBCL，以及 povorcitinib 用於 HS。

As we've discussed, our core business ex Jakafi has the potential to approach $3 billion to $4 billion by 2030, reflecting the strength of the portfolio and continued execution. It is becoming an increasingly important part of how we transition the company for long-term growth.

如我們先前所討論，不含 Jakafi 的核心業務到 2030 年有潛力接近 30 億至 40 億美元，反映產品組合的實力與持續的執行力。這也正逐步成為我們推動公司長期成長轉型中愈發重要的一環。

Opzelura continues to be the largest single contributor to the core business ex Jakafi with sales of $143 million, up 20% versus prior year. In the US, sales were $106 million, an increase of 12% versus the first quarter of '25.

Opzelura 仍是不含 Jakafi 的核心業務中最大單一貢獻者，銷售額為 1.43 億美元，較去年同期成長 20%。在美國，銷售額為 1.06 億美元，較 2025 年第一季成長 12%。

The underlying prescription demand for this business is strong, up 17% year-over-year, which is supported by the continued adoption of nonsteroidal topical therapies. Internationally, growth remains robust in vitiligo where we see strong uptake across markets.

此業務的基礎處方需求強勁，年增 17%，並受惠於非類固醇外用療法的持續採用。在國際市場方面，白斑症的成長仍然強勁，我們看到各市場的採用率都很高。

In the first quarter, sales totaled $37 million, up 56% year-over-year. Internationally, growth remains robust in Vitiligo, where we see strong uptake across markets. As a reminder, Opzelura is under review by European regulators for moderate AD, and we expect approval and launch in the second half of the year.

第一季銷售額合計 3,700 萬美元，年增 56%。在國際市場方面，白斑症的成長仍然強勁，我們看到各市場的採用率都很高。提醒一下，Opzelura 目前正由歐洲監管機構審查用於中度 AD，我們預期將於今年下半年獲准並上市。

The moderate AD indication has the potential to contribute meaningfully to top line revenue beginning later this year. For full year '26, we anticipate that roughly 80% of revenue will come from the US and 20% from international markets.

中度 AD 適應症有望自今年稍晚開始對營收（top line）做出顯著貢獻。就 2026 全年而言，我們預期約 80% 的營收將來自美國，20% 來自國際市場。

In Hematology and Oncology, net sales grew 116% to $204 million. Niktimvo, Monjuvi and Zynyz were the largest contributors to growth in the quarter. Niktimvo has now entered its second year following its launch in the first quarter of '25.

在血液學與腫瘤領域，淨銷售額成長 116% 至 2.04 億美元。Niktimvo、Monjuvi 與 Zynyz 是本季成長的最大貢獻者。Niktimvo 於 2025 年第一季上市後，目前已進入上市後第二年。

Net sales were $55 million in the first quarter of '26, reflecting a strong consistent new patient start profile and solid persistency. We've built a broad growing prescriber base with virtually every BMT center in the United States using Niktimvo with all becoming repeat customers.

2026 年第一季淨銷售額為 5,500 萬美元，反映出強勁且一致的新病人起始用藥表現，以及穩健的持續用藥率。我們已建立廣泛且持續成長的處方醫師基礎，美國幾乎所有 BMT 中心都在使用 Niktimvo，且皆已成為回購客戶。

Within 12 months, Niktimvo has captured 32% of the third line plus market. Finally, formulary and payer coverage remains strong for the brand.

在 12 個月內，Niktimvo 已取得第三線以上市場 32% 的市占。最後，該品牌的處方集（formulary）與支付方（payer）給付覆蓋仍然強勁。

Monjuvi sales were $49 million in the first quarter, up 67% year-over-year. Growth was primarily driven by uptake in follicular lymphoma following approvals in the US and international markets. Looking ahead, the potential US approval in first-line DLBCL represents an incremental growth opportunity starting in 2027.

Monjuvi 第一季銷售額為 4,900 萬美元，年增 67%。成長主要由於在美國及國際市場獲批後，於濾泡性淋巴瘤的採用增加。展望未來，若在美國取得第一線 DLBCL 的核准，將自 2027 年起帶來額外的成長機會。

Finally, Zynyz sales were $41 million in the first quarter with rapid and robust adoption in SCAC. Now I'll turn the call over to Pablo.

最後，Zynyz 第一季銷售額為 4,100 萬美元，並在 SCAC 中快速且強勁地被採用。接下來我把電話會議交給 Pablo。

Thank you, Bill, and good morning, everyone. We have made strong progress year-to-date across our hematology, oncology and immunology franchises, delivering key regulatory and clinical accomplishments.

謝謝你，Bill，各位早安。我們今年迄今在血液學、腫瘤學與免疫學事業群均取得強勁進展，並達成多項關鍵的法規與臨床里程碑。

Turning to hematology. We achieved several important milestones for 989, our mutant CALR monoclonal antibody, where pivotal development efforts continue to advance. Most notably, this includes the positive end-of-phase meeting with the FDA in the first quarter.

先談血液學。我們在 989（針對突變 CALR 的單株抗體）上達成數項重要里程碑，關鍵性（pivotal）開發工作持續推進。最值得注意的是，我們在第一季與 FDA 進行了正向的期末（end-of-phase）會議。

As a result, we're on track to initiate the Phase 3 study evaluating 989 in patients with previously treated essential thrombocythemia midyear, a key inflection point for this program. Our JAK2 V617F inhibitor program, 058, continues to progress.

因此，我們按計畫將於年中啟動第 3 期研究，評估 989 用於既往治療過的原發性血小板增多症（ET）患者，這是該計畫的重要轉折點。我們的 JAK2 V617F 抑制劑計畫 058 也持續推進。

During the first quarter, we initiated our Phase 1 dose escalation study evaluating the ASD formulation of 058 in MPN patients with a JAK2 mutation.

第一季期間，我們啟動了第 1 期劑量遞增研究，評估 058 的 ASD 劑型用於帶有 JAK2 突變的 MPN 患者。

Preliminary data in a modest number of patients is anticipated by year-end, which we expect will provide early evidence of clinical efficacy as well as an increased understanding of the viability of the ASD formulation for future development efforts.

預期在年底前可取得少量患者的初步數據，我們預期這將提供早期的臨床療效證據，並加深對 ASD 劑型在未來開發中可行性的理解。

In parallel, we're progressing our next-generation compounds through preclinical studies. We remain confident in the underlying thesis that the inhibition of V617F will lead to positive clinical outcomes in patients with MPNs that harbor this mutation.

同時，我們也正推進下一代化合物進入臨床前研究。我們仍對核心假設充滿信心：抑制 V617F 將為帶有此突變的 MPN 患者帶來正向的臨床結果。

Lastly, in addition to the previously announced positive top line data for tafasitamab in first-line DLBCL, we plan to present the full data set during a featured oral presentation at the upcoming ASCO Annual Meeting in June.

最後，除了先前已公布 tafasitamab 用於第一線 DLBCL 的正向主要結果（top line data）外，我們計畫於 6 月即將舉行的 ASCO 年會上，以重點口頭報告（featured oral presentation）形式發表完整數據集。

This data supports global regulatory submissions for tafasitamab in first-line DLBCL with approval and launch anticipated early next year.

這些數據支持 tafasitamab 用於第一線 DLBCL 的全球法規申請，並預期於明年初獲准並上市。

Turning to oncology. During the quarter, Zynyz was approved by the European Commission for patients who previously untreated squamous cell anal carcinoma, adding a second indication for Zynyz in Europe.

接著談腫瘤學。本季 Zynyz 獲歐盟執委會核准，用於先前未治療的鱗狀細胞肛門癌患者，為 Zynyz 在歐洲新增第二項適應症。

In our pipeline, this month, we initiated a Phase 3 study evaluating our KRAS G12D inhibitor, 734 in combination with chemotherapy in first-line pancreatic ductal adenocarcinoma or PDAC patients.

在我們的研發管線方面，本月我們啟動第 3 期研究，評估 KRAS G12D 抑制劑 734 與化療併用，用於第一線胰臟導管腺癌（PDAC）患者。

This marks a significant step for the program as it enters late-stage development in a setting with substantial medical need. Finally, in immunology, we have made meaningful regulatory and clinical progress advancing our late-stage portfolio.

這標誌著該計畫邁出重要一步，進入在高度未被滿足醫療需求情境下的後期開發。最後，在免疫學方面，我們在推進後期產品組合上取得具意義的法規與臨床進展。

Notably, this includes the new drug application acceptance by the FDA for povorcitinib in moderate to severe hidradenitis suppurativa as well as the positive results of our Phase 3 registrational program evaluating povorcitinib in patients with nonsegmental vitiligo.

其中值得注意的是：FDA 已受理 povorcitinib 用於中度至重度化膿性汗腺炎（hidradenitis suppurativa）的新藥申請（NDA），以及我們評估 povorcitinib 用於非節段型白斑症患者的第 3 期註冊性計畫取得正向結果。

I will now turn to 989. In the first quarter, we had a positive end of phase meeting with the FDA on the development program in ET.

接下來我將談 989。第一季我們就 ET 的開發計畫與 FDA 進行了正向的期末（end of phase）會議。

The Phase 3 trial will evaluate 989 compared to best available therapy in both type 1 and nontype 1 mutant CALR positive patients with ET who are resistant or intolerant to at least one prior cytoreductive therapy.

第 3 期試驗將比較 989 與最佳可用治療（best available therapy），納入對至少一種既往細胞減量治療（cytoreductive therapy）具抗藥性或不耐受的 ET 患者，涵蓋第 1 型與非第 1 型突變 CALR 陽性患者。

The trial will utilize a flexible dosing schedule starting with 750 milligrams IV every two weeks, with a single dose escalation option built in to allow for appropriate optimization based on early platelet response. The primary endpoint is durable complete hematologic response or DCHR at week 24.

試驗將採用彈性給藥時程，起始為每兩週靜脈注射（IV）750 毫克，並內建一次劑量上調選項，以便依早期血小板反應進行適當最佳化。主要終點為第 24 週的持久完全血液學反應（durable complete hematologic response, DCHR）。

The reduction of mutant CALR VAF from baseline will be evaluated as a key secondary endpoint in the trial, further underscoring the unique mutation-specific and potentially disease modifying profile of 989.

試驗亦將把突變 CALR 的 VAF 相較基線的下降幅度作為關鍵次要終點進行評估，進一步凸顯 989 具突變特異性且可能具疾病修飾（disease modifying）特徵的獨特輪廓。

We're encouraged by our dialogue with the FDA and have a clear and executable path towards forward in second-line ET with a Phase 3 study on track to initiate midyear. In parallel to ET, we're progressing our development efforts in myelofibrosis, or MF, where we are evaluating 989 as the first and second line treatment option.

我們對與 FDA 的對話感到鼓舞，並已具備清晰且可執行的路徑，推進第二線 ET；第 3 期研究仍按計畫於年中啟動。與 ET 並行，我們也在骨髓纖維化（MF）推進開發，評估 989 作為第一線與第二線治療選項。

Data from our ongoing Phase 1 program will be shared throughout the year. We remain on track to initiate a Phase 3 trial evaluating 989 as a second-line treatment in mutant CALR positive patients with MF in the second half of 2026, pending alignment with the FDA in the middle of the year.

我們正在進行的第 1 期計畫數據將於全年陸續分享。我們仍按計畫於 2026 年下半年啟動第 3 期試驗，評估 989 作為突變 CALR 陽性 MF 患者的第二線治療；前提是於年中與 FDA 達成一致。

The Phase 1 cohort evaluating 989 as a single agent and in combination with ruxolitinib in patients with previously untreated MF is enrolling well.

第 1 期隊列正在評估 989 作為單藥，以及與 ruxolitinib 併用，用於先前未治療的 MF 患者；目前收案進展良好。

Finally, we initiated and completed a Phase 1 study evaluating a subcutaneous formulation of 989 in healthy volunteers, supporting our strategy to expand utility and improve convenience for patients. These results enable the initiation of a Phase 1 study in mutant CALR positive patients in the second quarter.

最後，我們已啟動並完成一項第 1 期研究，在健康受試者中評估 989 的皮下注射劑型，以支持我們擴大使用情境並提升患者便利性的策略。這些結果使我們得以在第二季啟動一項針對突變 CALR 陽性患者的第 1 期研究。

I will now turn to our oncology portfolio. Starting with 734, a KRAS G12D inhibitor, which is emerging as a very important pipeline opportunity for Incyte. The Phase 3 trial evaluating 734 in combination with standard of care chemotherapy, gemcitabine plus nab-paclitaxel or modified FOLFIRINOX in first-line PDAC is underway.

接下來我將談我們的腫瘤產品組合。先從 734（KRAS G12D 抑制劑）開始，這正逐漸成為 Incyte 研發管線中非常重要的機會。評估 734 與標準治療化療併用的第 3 期試驗已展開；在第一線 PDAC 中，化療方案為吉西他濱（gemcitabine）加白蛋白結合型紫杉醇（nab-paclitaxel），或改良版 FOLFIRINOX。

More than 200,000 patients are diagnosed with PDAC with G12D being the most common driver mutation impacting 40% of patients. Today, there are no molecular targeted therapies for patients with pancreatic cancer and chemotherapy has been the foundation of care for decades.

每年有超過 20 萬名患者被診斷為 PDAC，其中 G12D 是最常見的驅動突變，影響約 40% 的患者。時至今日，胰臟癌患者仍缺乏分子標靶治療，而化療數十年來一直是治療基石。

What we believe is particularly important is the combination profile of 734 with standard of care chemotherapy.

我們認為特別重要的是 734 與標準治療化療的併用特性。

To date, 734 has demonstrated a manageable tolerability profile when combined with either gemcitabine plus nab-paclitaxel or modified FOLFIRINOX without compromising chemotherapy dose intensity.

截至目前，734 與吉西他濱加 nab-paclitaxel 或改良版 FOLFIRINOX 併用時，已展現可管理的耐受性特徵，且不會影響化療的劑量強度。

Given how PDAC is treated in practice, especially in the first-line setting, that ability to combine effectively with both full dose chemotherapy regimens is critical. This is reflected in our Phase 3 development program.

考量 PDAC 在臨床實務中的治療方式，尤其在第一線情境下，能夠有效與兩種全劑量化療方案併用至關重要。這也反映在我們的第 3 期開發計畫中。

Our maturing Phase 1 data reinforces our conviction in this opportunity, which we view as increasingly derisked. We plan to share efficacy and safety data from the Phase 1 study in combination with modified FOLFIRINOX and gem/nab in first-line PDAC patients in the second half of the year.

我們逐漸成熟的第 1 期數據強化了我們對此機會的信心，我們認為其風險正持續降低。我們計畫於今年下半年分享第 1 期研究中，734 與改良版 FOLFIRINOX 及 gem/nab 併用於第一線 PDAC 患者的療效與安全性數據。

A distinguishing feature of our development approach is the scale and depth of our Phase 1 clinical program where roughly 400 patients have been treated with 734 across PDAC, colorectal, non-small cell lung and other 12D mutated cancers.

我們研發策略的一項顯著特色，是我們第一期臨床計畫的規模與深度；約有 400 名患者接受了 734 的治療，涵蓋 PDAC、結直腸癌、非小細胞肺癌及其他 KRAS 12D 突變癌症。

This has allowed us to build a robust and comprehensive understanding of both clinical activity, safety and tolerability across tumor types and treatment settings, which is informing our development efforts.

這使我們得以建立對不同腫瘤類型與治療情境下之臨床活性、安全性與耐受性的穩健且全面的理解，並正用以指引我們的研發工作。

With a strong early clinical foundation and Phase 3 development now underway, our focus remains on execution as we advance this program that has the potential to become the first KRAS G12D specific inhibitor approved in first-line PDAC.

在強勁的早期臨床基礎之上，且第三期開發現已展開之際，我們仍將重點放在執行力，推進此一計畫；該計畫有潛力成為首個在一線 PDAC 獲批的 KRAS G12D 特異性抑制劑。

In parallel, we continue to evaluate expansion opportunities in additional G12D-driven tumors, and we plan to share more about our efforts later this year.

同時，我們持續評估在其他由 G12D 驅動的腫瘤中的擴展機會，並計畫在今年稍晚分享更多相關進展。

Our oncology portfolio has reached an important inflection point with each of our core programs now in registrational development and actively enrolling patients. Pivotal efforts for 890, a TGF-beta receptor two by PD-1 bispecific are underway.

我們的腫瘤產品組合已到達重要的拐點：各核心計畫目前皆已進入註冊性開發階段，並正積極招募患者。針對 890（一款 TGF-beta 受體 II × PD-1 雙特異性抗體）的關鍵性工作正在進行中。

The Phase 3 trial evaluating 890 in combination with FOLFOX bevacizumab in first-line MSS colorectal cancer patients is ongoing. In the second half of the year, we anticipate sharing additional data from the Phase 1 study in combination with FOLFOX bev, in first-line colorectal patients as well as a combination with bevacizumab in previously treated patients with colorectal cancer.

評估 890 與 FOLFOX 及 bevacizumab 聯合用於一線 MSS 結直腸癌患者的第三期試驗正在進行中。今年下半年，我們預期將分享第一期研究的更多數據，包括與 FOLFOX/bev 聯合用於一線結直腸癌患者，以及與 bevacizumab 聯合用於既往治療過的結直腸癌患者。

667, our CDK2 inhibitor is in pivotal development in patients with platinum-resistant ovarian cancer with Cyclin E1 over expression, a biomarker-defined population with significant medical need.

667（我們的 CDK2 抑制劑）正於鉑類抗藥性卵巢癌且 Cyclin E1 過度表現的患者中進行關鍵性開發；此為以生物標記界定、具有重大醫療需求的人群。

The MAESTRA clinical program consists of three studies, two ongoing trials, a Phase 2 single arm study and a Phase 3 study versus investigator's choice chemotherapy and a planned Phase 3 study in the first-line maintenance setting, which we expect to initiate in the second half of 2026.

MAESTRA 臨床計畫由三項研究組成：兩項進行中的試驗（第二期單臂研究與第三期、對照研究者選擇化療），以及一項規劃中的第三期一線維持治療情境研究，我們預期將於 2026 年下半年啟動。

Finally, in immunology, we have made significant progress advancing our late-stage development efforts for povorcitinib, our oral JAK1 small molecule inhibitor. This includes the NDA acceptance in HS and as announced today, the positive results from our Phase 3 registrational program in nonsegmental vitiligo.

最後，在免疫學方面，我們在推進 povorcitinib（我們的口服 JAK1 小分子抑制劑）後期開發工作上取得重大進展。這包括其在 HS 的 NDA 受理，以及如今日所宣布，我們在非節段型白斑之第三期註冊性計畫取得正面結果。

In HS, last month, at the American Academy of Dermatology Annual Meeting, we presented late-breaking 54 week data from our Phase 3 STOP-HS program, which reinforced both the durability and the breadth of response associated with long-term povorcitinib treatment.

在 HS 方面，上個月於美國皮膚科學會年會上，我們發表了第三期 STOP-HS 計畫的 54 週最新數據，進一步強化長期 povorcitinib 治療所帶來反應的持久性與廣泛性。

Continuous improvements in clinical outcomes were observed at week 54 and with up to 71% and 57% of patients achieving HiSCR50 and HiSCR75 respectively.

在第 54 週觀察到臨床結果持續改善，且分別有高達 71% 與 57% 的患者達到 HiSCR50 與 HiSCR75。

Further, up to 29% of patients achieved HiSCR100, the most stringent end point in HS which represents a 100% reduction in abscesses and inflammatory nodules count with no increase in draining tunnels. Up to 20% of patients achieved complete clearance of draining tunnels and nodules at week 54.

此外，高達 29% 的患者達到 HiSCR100（HS 中最嚴格的終點），代表膿瘍與發炎性結節數量降低 100%，且引流性瘻管未增加。至第 54 週，高達 20% 的患者達到引流性瘻管與結節的完全清除。

Clinically meaningful improvements in skin pain, fatigue and quality of life measures, outcomes that are highly relevant to patients and clinicians managing this chronic disease were also observed.

同時也觀察到在皮膚疼痛、疲勞與生活品質指標上具有臨床意義的改善；這些結果對於管理此慢性疾病的患者與臨床醫師高度相關。

Finally, from a safety perspective, both 45 and 75 milligram doses were generally well tolerated throughout the study, supporting the profile for chronic use in HS.

最後，從安全性角度來看，45 與 75 毫克劑量在整個研究期間整體耐受性良好，支持其在 HS 的慢性使用特性。

This data supports the potential for povorcitinib to deliver symptom control and durable disease improvement in patients with moderate to severe HS, both before and after biologic therapy.

這些數據支持 povorcitinib 有潛力為中重度 HS 患者提供症狀控制與持久的疾病改善，無論是在生物製劑治療之前或之後。

With the regulatory application accepted, we look forward to working with the FDA towards a potential approval and launch in early 2027. Today, we also announced positive results from our Phase 3 program evaluating povorcitinib in adults with nonsegmental vitiligo.

隨著法規申請已獲受理，我們期待與 FDA 合作，朝向可能於 2027 年初獲批並上市的目標邁進。今天，我們也宣布第三期計畫在非節段型白斑成人患者中評估 povorcitinib 的正面結果。

Our Phase 3 program is evaluating the efficacy, safety and tolerability of povorcitinib compared to placebo in patients with nonsegmental vitiligo across two identical Phase 3 studies, STOP-V1 and STOP-V2 for 52 weeks.

我們的第三期計畫透過兩項相同設計的第三期研究（STOP-V1 與 STOP-V2），在 52 週期間評估 povorcitinib 相較安慰劑於非節段型白斑患者的療效、安全性與耐受性。

The program enrolled over 900 patients including 456 patients who received a 30 milligram dose of povorcitinib.

該計畫納入超過 900 名患者，其中 456 名患者接受 30 毫克劑量的 povorcitinib。

In both trials, povorcitinib achieved the primary endpoint of greater than or equal to 75% reduction in facial vitiligo area scoring index, F-VASI75, from baseline to week 52, demonstrating statistically significant and clinically meaningful reductions in facial vitiligo compared to placebo.

在兩項試驗中，povorcitinib 皆達成主要終點：自基線至第 52 週，臉部白斑面積評分指數（F-VASI）降低大於或等於 75%（F-VASI75），顯示相較安慰劑在臉部白斑方面具有統計顯著且具臨床意義的降低。

Statistically significant improvements were also observed in key secondary endpoint measures including total vitiligo area scoring index 50 or T-VASI50 at week 52. The 30 milligram dose of povorcitinib was well tolerated.

在關鍵次要終點指標上亦觀察到統計顯著改善，包括第 52 週的全身白斑面積評分指數 50（T-VASI50）。30 毫克劑量的 povorcitinib 耐受性良好。

The overall safety profile for 52 weeks is consistent with prior studies with no new safety signals observed. Across both studies, rates of treatment-emergent adverse events of special interest were low between 2% and 3% and similar between the povorcitinib and placebo treatment groups.

52 週的整體安全性概況與既往研究一致，未觀察到新的安全性訊號。在兩項研究中，特別關注之治療期間出現不良事件（TEAE）的發生率偏低，介於 2% 至 3%，且 povorcitinib 與安慰劑組相近。

There were no major adverse cardiovascular events. Only one TEAE of VTE was observed in the povorcitinib treatment group in a patient with multiple confounding risk factors, including smoking history, high BMI and intercurrent pneumonia.

未出現重大不良心血管事件。在 povorcitinib 治療組僅觀察到 1 例 VTE 的 TEAE，該患者具有多項混雜風險因子，包括吸菸史、高 BMI 以及合併發生的肺炎。

These results provide a clear and compelling path towards registration planned for the first half of 2027 and underscore the opportunity to add an oral alternative treatment for patients with vitiligo to our portfolio. We plan to share additional data from the trials in the second half of 2026.

這些結果為我們規劃於 2027 年上半年進行註冊申請提供清晰且具說服力的路徑，並凸顯將口服替代治療選項納入我們白斑產品組合的機會。我們計畫於 2026 年下半年分享試驗的更多數據。

Povorcitinib continues to produce compelling data in immune-mediated dermatological conditions. We have seen success in translating early Phase 2 findings into larger registrational programs with now four positive Phase 3 trials across HS and vitiligo.

Povorcitinib 在免疫介導的皮膚疾病中持續產出具吸引力的數據。我們已成功將早期第二期發現轉化為更大型的註冊性計畫，目前在 HS 與白斑領域合計已有四項第三期試驗取得正面結果。

As we look ahead, we expect data from our third indication for prurigo nodularis by end of year. In addition to povorcitinib, we are evaluating Opzelura in a Phase 3 registrational program for the treatment of mild to moderate HS with top line results expected end of year.

展望未來，我們預期在年底前取得第三個適應症——結節性癢疹——的數據。除 povorcitinib 外，我們亦正在進行 Opzelura 用於輕至中度 HS 治療的第三期註冊性計畫，預期年底公布主要結果。

If positive, this result would support a supplemental new drug application in 2027. And if approved, Opzelura would provide the first topical treatment option for patients with HS.

若結果為正，將支持於 2027 年提出補充新藥申請。若獲批准，Opzelura 將為 HS 患者提供首個外用治療選項。

Our JAK-anchored franchise is well positioned to provide topical to oral solutions across mild to severe immune-mediated dermatological conditions, and we look forward to providing more updates this year.

我們以 JAK 為核心的產品版圖具備良好定位，可針對輕至重度免疫介導皮膚疾病提供從外用到口服的解決方案，我們也期待在今年提供更多更新。

To close, we have a catalyst-rich year ahead with multiple late-stage data readouts, regulatory milestones and pivotal trial initiations across our three core franchises, underscoring the breadth, depth and maturity of our pipeline.

總結而言，未來一年將有多項催化事件，包括多個後期數據讀出、法規里程碑，以及在三大核心事業領域啟動關鍵性試驗，凸顯我們研發管線的廣度、深度與成熟度。

With that, I'll turn it over to Tom for a financial update on the quarter.

接下來我把時間交給 Tom，為本季提供財務更新。

Thanks, Pablo. As Bill mentioned earlier, our total revenues and net sales for the first quarter were $1.27 billion and $1.10 billion, respectively, increasing 21% and 20% from the prior year.

謝謝你，Pablo。如 Bill 先前提到，我們第一季的總營收與淨銷售額分別為 12.7 億美元與 11.0 億美元，較去年同期分別成長 21% 與 20%。

Our GAAP R&D expenses were $516 million for the quarter, increasing 18% from the prior year, driven by continued investment in our late-stage development assets including our mutant CALR, G12D and CDK 2 programs.

本季 GAAP 研發費用為 5.16 億美元，較去年同期增加 18%，主要由於我們持續投資於後期開發資產，包括突變 CALR、G12D 與 CDK2 計畫。

Moving to SG&A. GAAP SG&A expenses were $328 million for the quarter, increasing 1% year-over-year. Ongoing operating expenses for the first quarter of 2026 increased 14% year-over-year compared to a 19% increase in ongoing revenues during the same period, leading to a continued increase in operating leverage and margins.

接著看 SG&A。本季 GAAP 銷售、一般及行政費用為 3.28 億美元，年增 1%。2026 年第一季的持續性營運費用年增 14%，相較同期間持續性營收年增 19%，帶動營運槓桿與利潤率持續提升。

We reaffirm our full year 2026 total net sales, R&D and SG&A operating expense guidance. Total net sales guidance for the full year 2026 is $4.77 billion to $4.94 billion representing a 10% to 13% increase from the prior year.

我們重申 2026 全年總淨銷售額、研發與 SG&A 營運費用指引。2026 全年總淨銷售額指引為 47.7 億至 49.4 億美元，較去年增加 10% 至 13%。

This includes net sales expectations for Jakafi of $3.22 billion to $3.27 billion, Opzelura of $750 million the $790 million and hematology and oncology products of $800 million to $880 million.

其中包括 Jakafi 淨銷售額預期為 32.2 億至 32.7 億美元，Opzelura 為 7.50 億至 7.90 億美元，以及血液與腫瘤產品為 8.00 億至 8.80 億美元。

Total GAAP R&D and SG&A operating expenses are expected to be $3.495 billion to $3.675 billion for the full year. Finally, we anticipate cost of sales to remain relatively stable, representing approximately 9% of net sales. I'll now turn the call back over to Bill.

預計全年 GAAP 研發（R&D）與銷售、一般及行政（SG&A）營運費用合計將為 34.95 億美元至 36.75 億美元。最後，我們預期銷貨成本將維持相對穩定，約占淨銷售額的 9%。我現在把電話交回給 Bill。

Thanks, Tom. In closing, we’re off to a strong start to the year. Our core business continues to deliver durable growth. Our pipeline is advancing with multiple catalysts ahead. We’ve strengthened our leadership team to support the next phase of execution.

謝謝你，Tom。總結來說，我們今年開局強勁。我們的核心業務持續帶來具韌性的成長。我們的研發管線正在推進，未來有多項催化劑。我們也強化了領導團隊，以支持下一階段的執行。

As we look ahead, we see 2026 as a year of execution with multiple inflection points across the business that we believe will further strengthen both our near-term performance and long-term growth trajectory.

展望未來，我們將 2026 年視為一個以執行為主、且業務各面向將出現多個拐點的一年；我們相信這將進一步強化我們的短期表現與長期成長軌跡。

With that, I’ll turn the call over to the operator for Q&A.

接下來，我把電話交給接線員進行問答。

(Operator Instructions) Tazeen Ahmad, Bank of America.

（接線員指示）Tazeen Ahmad，美國銀行。

Congrats on the positive data for POVO for non-segmental vitiligo. I wanted to ask what your thoughts are as you prepared the next steps. How do you see this coexisting with Opzelura in the commercial space? You know, what’s been your experience with marketing this indication so far? Do you think that each of these drugs could be appealing for a different segment of vitiligo? Thanks.

恭喜你們在 POVO 用於非節段型白斑方面取得正向數據。我想請教你們在準備下一步時的想法。你們如何看待它在商業市場上與 Opzelura 共存？你們到目前為止在推廣這個適應症方面的經驗如何？你們是否認為這兩種藥物各自可能對白斑的不同族群更具吸引力？謝謝。

Yeah, thanks for the question, Tazeen. I’ll make a few comments and then ask Mohamed Issa, our US Commercial Head, to also expand on how we’re thinking about vitiligo. I think there’s a real opportunity here with the FDA approvals of oral treatments to essentially unlock the vitiligo market in the same way that, you know, advanced systemic therapies unlocked AD and psoriasis. I think that these approvals will create awareness that vitiligo is a chronic inflammatory disorder, and I think that is important for everybody that’s going to be in the vitiligo market. This is definitely about medicalizing the condition. Frankly, I think Incyte does have an advantage in that we have a topical to oral solution.

好的，謝謝你的問題，Tazeen。我先講幾點，然後請我們美國商業負責人 Mohamed Issa 也補充我們如何思考白斑。我認為，隨著 FDA 核准口服治療，確實有機會像先進全身性療法解鎖異位性皮膚炎（AD）與乾癬市場那樣，實質上解鎖白斑市場。我認為這些核准將提升大眾對白斑是一種慢性發炎性疾病的認知，而這對所有將進入白斑市場的參與者都很重要。這確實是在把這個狀況「醫療化」。坦白說，我認為 Incyte 的優勢在於我們同時擁有從外用到口服的解決方案。

There is a natural sequencing that sets up in the vitiligo market, and we’re able to cover sort of the waterfront with both Opzelura as well as with povorcitinib. And that’s ultimately going to be, I think, the key to success here. We have the advantage of incumbency. We have direct ties to the providers. We know how they think about this condition. We understand the education that’s required to increase the treatment rate. And we of course, have interactions with payers on this front too. And so I think it’s going to be an important contributor to POVO being one of the three indications that we’re pursuing right now.

白斑市場會自然形成一種治療順序，而我們能以 Opzelura 以及 povorcitinib 兩者覆蓋各種需求。我認為這最終將是成功的關鍵。我們具備先行者優勢。我們與醫療提供者有直接連結。我們了解他們如何看待這個疾病。我們也理解為了提高治療率所需的教育內容。當然，我們在這方面也與支付方有所互動。因此，我認為這將成為 POVO 目前正在推進的三個適應症之一的重要貢獻來源。

Mohamed, do you have anything to add?

Mohamed，你有要補充的嗎？

No, really well said, Bill. Look, you know, maybe just some context to the indications. We have, obviously reason to believe there’s 1.5 million people living with vitiligo in the US, and only 20%to 30% seek treatment, like Bill mentioned. A good portion of those patients, about 35% of them, have a BSA less than 5. Those are going to be really good patient segments for Opzelura. You even have a patient segment between 5 and 10 BSA. That’s also a target patient population for Opzelura. Then for patients with BSA greater than 10 where systemic therapy is most likely, we estimate that total addressable market to be about $1.5 billion to $2 billion, which gives povorcitinib a great opportunity to address that need as well. Like Bill mentioned, having a topical to oral continuum for vitiligo and even HS if both products get approved, puts us in a really unique position as Incyte to satisfy that patient journey from the beginning all the way to advanced treatment.

沒有，Bill 說得很好。補充一些適應症的背景：我們顯然有理由相信美國約有 150 萬人罹患白斑，而如 Bill 所提，只有 20% 到 30% 會尋求治療。其中相當一部分患者，大約 35%，其體表面積（BSA）小於 5%。這些會是 Opzelura 非常合適的患者族群。甚至還有一群 BSA 介於 5 到 10 的患者，這也是 Opzelura 的目標族群。接著，對於 BSA 大於 10、較可能需要全身性治療的患者，我們估計其可服務的總市場約為 15 億至 20 億美元，這也讓 povorcitinib 有很好的機會去滿足該需求。如 Bill 所說，若兩個產品都獲核准，白斑、甚至化膿性汗腺炎（HS）都能形成從外用到口服的連續治療路徑，讓我們 Incyte 在滿足患者從初期到進階治療的整段旅程上，處於非常獨特的位置。

James Shin, Deutsche Bank

James Shin，德意志銀行。

Hey, good morning, guys. Appreciate all the color on 989. I just wanted to check in. Will 989 EHA update be mostly a check-the-box kind of update, or will there be some new wrinkles to glean? Just if I could sneak one in, I don’t know if Suky’s on the call, Bill, I know you guys mentioned previously having expense discipline, what changes, if any, will Suky bring? Thank you.

各位早安。感謝你們提供關於 989 的各種細節。我想確認一下：989 在 EHA 的更新會主要是例行性的「打勾」式更新，還是會有一些新的亮點可供解讀？另外如果我可以再問一題——我不確定 Suky 是否在線上，Bill——我知道你們之前提到費用紀律，Suky 會帶來哪些（若有的話）改變？謝謝。

Great, James. You snuck in a second question, so there may be a penalty after the call. I’ll let Pablo answer the first question.

很好，James。你偷渡了第二個問題，所以通話結束後可能要罰你。我先讓 Pablo 回答第一個問題。

Thank you for the question. The update at EHA, it’s going to be pretty substantial. We have continued to enroll in the studies, we have longer follow-up, and we have continued to deepen our translational understanding of the effects of 989 in patients with both ET and MF. You should expect continued growth in number of patients.

謝謝你的問題。EHA 的更新會相當有份量。我們持續在研究中收案，追蹤時間也更長，同時也持續加深我們對 989 在 ET 與 MF 患者中作用效果的轉譯醫學理解。你可以預期患者人數會持續增加。

In ET, we’ll have approximately 100 patients enrolled, and we’ll report data in those. For MF, in terms of the second line, we’ll have about 45 patients, single agent and about 15 to16 patients in combination with ruxolitinib. I think, first of all, the data has continued to evolve well. We think the durability is an important point. We think the continued tolerability of 989 in this patient population is very important.

在 ET 方面，我們將有約 100 名患者入組，並會報告其數據。至於 MF，在二線治療方面，我們將有約 45 名患者使用單藥，另有約 15 到 16 名患者與 ruxolitinib 聯合治療。首先，我認為數據持續朝好的方向演進。我們認為療效持久性是一個重要重點。我們也認為 989 在這個患者族群中的持續耐受性非常重要。

We do think that we continue to see how the translational part of the story continues to evolve with clear evidence of disease eradication, disease modification by 989 in patients with MPN is very important. You should expect to see a lot more of that at EHA.

我們也確實看到，這個故事的轉譯部分持續演進；在 MPN 患者中，989 展現出清楚的疾病清除證據與疾病修飾效果，這非常重要。你可以預期在 EHA 看到更多這方面的內容。

Yeah. As it relates to Suky, look, he has extensive experience at both large and small companies. We have a very strong finance department at the company. He’s going to focus on the things that a CFO needs to focus on, both strategically and operationally. You want to make sure that your budget planning process is efficient and sharp. You want to make sure that capital allocation decisions are made intelligently. There’s of course a role in terms of setting up the right systems so that we can scale the company and, you know, we’re really glad to have him. Thanks, James.

至於 Suky，你看，他在大型與小型公司都有豐富經驗。我們公司本身也有非常強的財務部門。他會聚焦在 CFO 需要關注的事項，包含策略面與營運面。你會希望預算規劃流程有效率且精準；你會希望資本配置決策做得明智；當然也有一部分工作是建立正確的系統，讓我們能夠擴大公司規模。我們很高興他加入。謝謝，James。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

Yeah, good morning. Thanks for taking the question. I guess congrats on securing the 24 week DCHR endpoint in the pivotal ET trial.

早安。謝謝讓我提問。我想先恭喜你們在關鍵性 ET 試驗中確立了 24 週 DCHR 終點。

Just wondering if you can provide some more detail around the mechanics of dose escalation, just in terms of the platelet response criteria that will be used to trigger that, and then just how that works from a timing perspective.

想請你們就劑量遞增的機制提供更多細節，特別是將使用哪些血小板反應標準來觸發遞增，以及從時間安排角度來看整體如何運作。

Just as a follow-up, just given some of the flexibility here that you were given from the agency around the ET endpoint, just curious how you think this now kind of reads into your ability to secure additional flexibility from the agency in the pivotal second line MF trial. Thank you.

再追問一下：鑑於主管機關在 ET 終點上給了你們一些彈性，我想了解你們認為這會如何影響你們在關鍵性 MF 二線試驗中，向主管機關爭取額外彈性的能力。謝謝。

Go ahead, Pablo.

Pablo，你先請。

Certainly. Let me start with your last point there, because I think it’s very important. We had a very constructive set of interactions with FDA. We’re very, very happy how these conversations are going. I think they recognize how 989 is a fundamentally different way to treat patients with MPN.

當然。我先從你最後一點開始，因為我認為這非常重要。我們與 FDA 進行了一系列非常具建設性的互動。我們對這些對話的進展非常、非常滿意。我認為他們也認可 989 是一種從根本上不同的 MPN 治療方式。

It’s truly not only a molecular targeted therapy, but has the potential for disease modification, and that needs to be contemplated as we implement Phase 3 trials and as we select endpoint for this Phase 3 trials.

它不僅是真正的分子標靶治療，還具有疾病修飾的潛力；在我們執行第 3 期試驗以及為第 3 期試驗選擇終點時，這一點需要被納入考量。

In terms of the conversations on MF, we believe, as you alluded to, that this will allow us to have a conversation with FDA about defining endpoints in MF that truly reflect the effects of 989 in terms of normalizing hematopoiesis, which we think it’s a critical difference compared with existing therapies for patients with MF.

至於 MF 的討論，我們相信，如你所暗示的，這將使我們能與 FDA 討論如何在 MF 中定義能真正反映 989 作用的終點，例如在造血正常化方面的效果；我們認為這與現有 MF 治療相比是一個關鍵差異。

We’ll provide more updates on this later in the year, but we think that dialogue is going to be very constructive as it was in ET. In terms of your specific question about ET, if you remember the data we presented last year, with 989 dose in patients with ET is a very rapid normalization in platelet count.

我們會在今年稍晚提供更多更新，但我們認為這段對話將會非常具建設性，就像在 ET 上一樣。就您關於 ET 的具體問題而言，如果您還記得我們去年展示的數據，989 在 ET 病患中的給藥可非常快速地使血小板計數正常化。

That happens very soon after the first dose, and by the end of the first cycle, in about a month, most of the patients that will normalize platelets have done so.

這在第一劑後很快就會發生，而到第一個療程結束時、約一個月左右，大多數會使血小板正常化的病患都已經達成。

We believe that an early dose escalation at that point for patients that are not early responders is the right approach here to take into account the heterogeneity that we see sometimes in their responses. We believe that by this, we’ll be able to cover patients with all kinds of mutations and have a treatment effect across the board in patients with ET.

我們相信，對於那些早期未反應的病患，在那個時間點進行早期劑量上調是正確的做法，以反映我們有時在反應上看到的異質性。我們相信透過這樣做，我們將能涵蓋具有各種突變的病患，並在 ET 病患中全面產生治療效果。

Etzer Darout from Barclays.

Barclays 的 Etzer Darout。

Great. Thanks for taking the question and for today’s earnings update. We noticed the updated guidance for Ruxolitinib and Niktimvo, now in the second half versus early 2027 for first-line GVHD.

很好。感謝讓我提問，也感謝今天的財報更新。我們注意到 Ruxolitinib 與 Niktimvo 的最新指引：第一線 GVHD 的時間點現在是在下半年，而不是先前所說的 2027 年初。

Maybe if you could talk about your expectation for that study and given sort of the move up in timelines, potential to maybe accelerate the pivotal program in combo with Rux. Thanks.

也許您可以談談對該研究的預期；以及在時程提前的情況下，是否可能在與 Rux 的聯合用藥中加速關鍵性（pivotal）計畫。謝謝。

I want to make sure your question is related to Niktimvo and the Phase 3 study with Jakafi.

我想確認一下，您的問題是關於 Niktimvo 以及與 Jakafi 的第 3 期研究嗎？

Yeah, the move in the second now versus early 2027 that you had previously guided to.

是的，就是從先前指引的 2027 年初，改成現在的下半年。

Oh, go ahead, Pablo.

喔，Pablo，你先請。

Let me take that. The study, the randomized Phase 2 study combining Niktimvo with rux and comparing that with rux and steroids accrued very quickly, well ahead of schedule.

我來回答。這項隨機第 2 期研究將 Niktimvo 與 rux 聯合，並與 rux 加類固醇做比較，收案非常迅速，遠早於原定進度。

As a result of that, we will have data before the end of this year, and that will help us define the rest of the regulatory strategy to bring Niktimvo to first-line chronic graft-versus-host disease patients.

因此，我們將在今年年底前取得數據，這將幫助我們界定後續的法規策略，以將 Niktimvo 帶給第一線慢性移植物抗宿主病患者。

Ashwani Verma from UBS.

UBS 的 Ashwani Verma。

Hey, guys. Good morning. Thanks for taking our question. Just on 989, trying to understand the implications of this flexible dose escalation in ET pivotal trial design for the MF indication. I mean, how do you think that plays out?

各位早安。感謝讓我們提問。關於 989，我想了解在 ET 關鍵性試驗設計中採用這種彈性劑量上調，對 MF 適應症的意涵。我的意思是，您認為這會如何影響？

Like, could this be a challenge if you have to titrate patients and some don’t get the benefit of the efficacy unless you get the 2,500 mg dose? Especially like how would that be relevant if you’re pursuing the first-line MF indication? Thanks.

例如，如果你必須為病患滴定（titrate）劑量，而有些人除非到 2,500 mg 劑量才看得到療效，這會不會成為挑戰？特別是如果你在追求第一線 MF 適應症時，這會如何相關？謝謝。

When you look at the data that we presented, twice last year, a substantial percentage of patients with ET respond by normalizing platelet count at doses well below the dose escalation of 2,500.

從我們去年兩次展示的數據來看，相當比例的 ET 病患在遠低於 2,500 劑量上調階段的劑量下，就能透過血小板計數正常化而產生反應。

Based on that, we think that a starting dose of 750 milligrams IV every other week is the right way to start because a lot of the patients would normalize platelet count with that, and that alone will support achieving the primary endpoint of the study, which is durable complete hematologic response at 24 weeks.

基於此，我們認為以每兩週一次 750 毫克靜脈注射作為起始劑量是正確的方式，因為許多病患用這個劑量就能使血小板計數正常化，而僅此就能支持達成研究的主要終點，也就是在 24 週時的持久完全血液學反應。

There’s a percentage of patients, like it tends to happen with molecular targeted therapies, that are less sensitive to 989, and for those patients, we thought one step up to 2,500 should cover the efficacy in that patient population.

有一部分病患——就像分子標靶治療常見的情況——對 989 的敏感度較低；對於這些病患，我們認為往上調一階到 2,500 應可涵蓋該族群的療效需求。

We basically designed the study to try to cover the heterogeneity in this population. We believe that the early dose escalation step is the right way to do it.

我們基本上是為了涵蓋這個族群的異質性而設計此研究。我們相信早期劑量上調這一步是正確的做法。

We believe that the rapid effect of 989 normalizing platelets in patients that will do so, will allow us to very quickly make that determination. Obviously, as I mentioned at the beginning, we had a very constructive discussion with FDA, and we reached an agreement on this.

我們相信，對於那些會達成血小板正常化的病患，989 的快速作用將使我們能非常迅速地做出判斷。當然，如我一開始提到的，我們與 FDA 進行了非常具建設性的討論，並就此達成一致。

Michael Schmidt from Guggenheim.

Guggenheim 的 Michael Schmidt。

Hey, good morning. Thanks for taking my question. I had one on 734, the KRAS G12D program, nice to see the chemo combo study now up and running in PDAC.

早安。感謝讓我提問。我有一題關於 734，也就是 KRAS G12D 計畫；很高興看到化療聯合研究現在已在 PDAC 中啟動並運行。

Pablo, just curious how you think about, either potentially pursuing other registration opportunities in PDAC perhaps with investigational therapies such as pan-RAS inhibitors. How do you think about addressing other tumor types such as lung and colorectal cancers? Thanks so much.

Pablo，我想請教你如何看待：在 PDAC 中是否可能追求其他註冊（registration）機會，例如與泛 RAS 抑制劑等研究性療法聯用？以及你如何看待拓展到其他腫瘤類型，例如肺癌與大腸直腸癌？非常感謝。

Thank you for the question, Michael. First of all, let me just say we are very pleased how this data, the data are evolving. We’ll have an update for all of you later in the year, the combination with chemotherapy, which we showed the tolerability early this year at the ASCO GI meeting.

謝謝你的問題，Michael。首先我想說，我們對這些數據的演進非常滿意。我們會在今年稍晚向各位更新；關於與化療的聯合，我們在今年稍早的 ASCO GI 會議上已展示其耐受性。

But now the response rate data is coming in, and we’ll have that as well as more durability data later in the year. We’re very pleased with the progress of this program, and the implementation of the Phase 3 pivotal trial in the first line.

但現在反應率數據正在陸續出來，我們也會在今年稍晚提供這些數據以及更多持久性（durability）數據。我們對此計畫的進展，以及第一線第 3 期關鍵性試驗的推進，非常滿意。

In parallel with that, we’ve done a lot of work in other contexts. First of all, in pancreatic cancer, we have a strong interest in adjuvant, we’re trying to decide the right design there.

與此同時，我們也在其他情境做了大量工作。首先，在胰臟癌方面，我們對輔助治療（adjuvant）有強烈興趣，正在決定那裡的合適設計。

You’ll hear more about that in the second half of the year. We’re also then combination with Erbitux. We’re doing one of the really important advantages of 734 in this competitive landscape is the absence of rash.

你們會在今年下半年聽到更多相關內容。我們也在與 Erbitux 的聯合上推進。734 在這個競爭格局中的一個非常重要優勢，是不會出現皮疹。

The combination with EGFR inhibitors is key, and it will be key, we believe, to develop these therapies in colorectal cancer. You’ll hear more about that later in the year, which could be both in combination with Erbitux alone or Erbitux plus chemotherapy in different lines of therapy in colorectal cancer.

與 EGFR 抑制劑的聯合是關鍵，而且我們相信，這將是於大腸直腸癌中開發這些療法的關鍵。你們會在今年稍晚聽到更多內容，可能包括僅與 Erbitux 聯合，或在大腸直腸癌不同治療線別中與 Erbitux 加化療聯合。

Finally, we have enrolled a cohort of patients with non-small cell lung cancer. We’ll have data on that in the second half of the year. All this gives you an idea how we’re going to potentially expand this program later in the year, and we’ll give you a comprehensive update when we present the updated data.

最後，我們已收納一個非小細胞肺癌病患隊列。我們會在今年下半年提供該部分數據。這些都讓你們了解我們可能如何在今年稍晚擴展此計畫；當我們展示更新後的數據時，也會提供全面性的更新。

Matt Phipps from William Blair.

William Blair 的 Matt Phipps。

Good morning. Thanks for taking my question. I’ll follow up on 734. Just wanted to confirm that all studies have resumed enrollment following that temporary pause a month or so ago to review those pneumonitis events. I guess, is a history of pneumonitis gonna be an exclusion criteria for DAWN-303 Phase 3 study? Thank you.

早安。感謝讓我提問。我想追問 734。想確認在大約一個月前為了檢視那些肺炎（pneumonitis）事件而短暫暫停後，所有研究是否都已恢復收案？另外，在 DAWN-303 第 3 期研究中，既往有肺炎病史是否會成為排除條件？謝謝。

So let me recap on what happened here because it's important to have clarity. We had the event of pneumonitis. We reported, we did a full program review that encounter 4 cases of pneumonitis in more than 350 patients treated.

我先回顧一下這裡發生的事情，因為釐清很重要。我們出現了肺炎事件。我們已通報並對整個計畫做了全面審查，在超過 350 名接受治療的病患中共遇到 4 例肺炎。

Importantly, three of those patients were receiving 734 in combination with chemotherapy. And two of the patients had concurrent infections. And an in-depth review of the data concluded there was no signal that about the incidence of 734 producing pneumonitis in these patients.

重要的是，其中 3 位病患是在 734 與化療聯合治療下用藥。而其中 2 位病患同時有感染。對數據進行深入審查後的結論是：沒有訊號顯示 734 在這些病患中會導致肺炎發生率上升。

But it's very important to remember. Now the Phase 3 study was never put on pause. What we did is in order to amend consent forms and investigator brochure, Europe, it's an administrative reason, they put enrollment on hold in the Phase 1 study.

但非常重要的是要記住：第 3 期研究從未暫停。我們所做的是，為了修訂同意書與研究者手冊，在歐洲出於行政原因，他們暫時停止了第 1 期研究的收案。

So that, those have been amended now. It will reopen. Nothing ever stopped in the US. We have continued to enroll patients. The implementation of the Phase 3 study continues apace without any interruptions.

因此，這些文件現在已完成修訂，將會重新開放。美國方面從未停止，我們持續收案。第 3 期研究的推進也持續按計畫進行，沒有任何中斷。

Judah Frommer from Morgan Stanley.

Morgan Stanley 的 Judah Frommer。

Just curious on Opzelura. If you could comment on competition, within the nonsteroidal topical market. Is that still a growing pie? Are you fighting for share just within the market kind of ex steroids?

想請教關於 Opzelura。你們能否評論一下在非類固醇外用藥市場中的競爭情況？那仍然是一個在成長的市場嗎？你們是在爭取市場份額，主要是在「非類固醇」這個市場內部競爭嗎？

And then just curious on, in terms of the long-term guide for Opzelura doubling, how important is it to have povo approved in those indications for those multiple tools within the tool bag for those indications?

另外也想請教，關於 Opzelura 長期指引要翻倍成長，在那些適應症中取得 povo 的核准有多重要？也就是在那些適應症的「工具箱」裡擁有多種工具這件事有多重要？

Yes, Judah, thanks for the question. I'll start with the second question that you asked and then double back on the first. When you think about this business over the next five years, there's essentially three components to growth.

是的，Judah，謝謝你的提問。我先從你問的第二個問題開始，然後再回過頭來談第一個。當你思考未來五年這項業務時，成長基本上有三個組成部分。

And I do believe Opzelura has the potential to grow it, let's call it, a 10% to 15% CAGR over this period of time. First component is organic growth, which is what you're talking about, continued penetration of the AD and vitiligo markets.

我確實相信 Opzelura 在這段期間有潛力實現我們姑且稱之為 10% 到 15% 的年複合成長率（CAGR）。第一個組成部分是有機成長，也就是你所提到的，持續提高在異位性皮膚炎（AD）與白斑症市場的滲透率。

The second component of growth is the launch of the HS indication for Opzelura and mild to moderate HS. And then there's the launch of Opzelura in Europe for atopic dermatitis, which could throw off $200 million to $300 million in incremental sales.

第二個成長組成部分是 Opzelura 在化膿性汗腺炎（HS）適應症上的上市，涵蓋輕度至中度 HS。接著是 Opzelura 在歐洲針對異位性皮膚炎的上市，這可能帶來 2 億到 3 億美元的增量銷售。

And it doesn't require any heroic math to forecast at Opzelura can approach $1 billion, let's call it $1.3 billion roughly by 2030. Now as it relates to competition in the United States, I'm not so much focused on these modest market share shifts that you can see between products on a monthly basis.

而且不需要做任何誇張的數學推算，就能預測 Opzelura 到 2030 年可接近 10 億美元，我們姑且說大約 13 億美元。至於美國的競爭，我並不太聚焦於你每月在產品之間看到的那些溫和的市占率變動。

A few points here. In the first quarter, our share of new patient starts in the United States was 46%. And new patient starts, as you know, our NBRx is sort of the future, it's growth. TRx is tell you a lot about the base and the past.

這裡有幾點。第一季我們在美國的新病人起始用藥（new patient starts）市占率是 46%。而新病人起始用藥，如你所知，我們的 NBRx 某種程度上代表未來、代表成長；TRx 則更多告訴你基礎盤與過去。

But when you're really monitoring and managing a business, you're focused on that NBRx number. NBRx volume or new patient start volume in the first quarter was up over 30% year-over-year and was at a higher rate than the market.

但當你真正監控與管理一項業務時，你會聚焦在 NBRx 這個數字。第一季 NBRx 量（或新病人起始用藥量）年增超過 30%，而且增速高於整體市場。

And we had 2 to 4 times more new patient starts in the first quarter than any of the other branded topicals. I think the real key here, and this is true for us as well as anybody else that has a topical is that the use TCIs of is starting to moderate, and there is a shift from TCIs and steroids to these nonsteroidal branded topicals.

而且第一季我們的新病人起始用藥數是其他任何品牌外用藥的 2 到 4 倍。我認為真正的關鍵在於——這對我們以及任何有外用產品的公司都一樣——鈣調神經磷酸酶抑制劑（TCIs）的使用開始趨於緩和，市場正從 TCIs 與類固醇轉向這些非類固醇的品牌外用藥。

And you see that month-to-month and quarter-to-quarter. I think the benefit we have is Opzelura is superior in terms of skin clearance and itch relief relative to a TCI. And it is a better long-term option than a steroid.

你可以在每月、每季的數據中看到這點。我認為我們的優勢是，相較於 TCI，Opzelura 在皮膚清除（skin clearance）與止癢（itch relief）方面更優；而且相較於類固醇，它是更好的長期選擇。

I think the product is set up perfectly over the next five years, and we're in a very, very strong position, and you have the benefit of operating in a market where there's a real tailwind, and that is the move away from steroids and TCIs.

我認為未來五年這個產品的布局非常到位，我們處於非常、非常強勢的位置；同時你也受惠於一個有明顯順風的市場，也就是從類固醇與 TCIs 轉移的趨勢。

I think that probably covers it. I think as it relates to Povo, I think that's upside. The fact that we are able in both vitiligo and in potentially HS to offer a complete treatment solution topical to oral, that's how I think about it. Thanks for the question.

我想這大概涵蓋了。至於 Povo，我認為那是上行空間。因為我們能在白斑症以及潛在的 HS 上，提供從外用到口服的完整治療方案——我就是這樣看待的。謝謝你的提問。

Ren Benjamin from Citizens.

Citizens 的 Ren Benjamin。

Congrats on the quarter. My question is on 058 in the Phase 1 with the new ASD formulation. Can you talk to us a little bit more about how we should be evaluating those results?

恭喜本季表現。我的問題是關於 058 在採用新的 ASD 劑型後所進行的第一期試驗。你們能否多談一些，我們應該如何評估這些結果？

And when we see it in the second half, what you're looking for and how we view this and will the deal you made with Prelude and that molecule for which you have an option. When do you guys ultimately make a decision between the two and how?

以及當我們在下半年看到結果時，你們在尋找什麼、我們應該如何看待這些結果？另外，你們與 Prelude 達成的交易以及那個你們擁有選擇權的分子，最終你們會在兩者之間何時、以及如何做出決策？

Thank you for the question. So as I mentioned during my prepared remarks, we are now in the clinic with the new formulation, and we're going to have an update for you before the end of the year.

謝謝你的提問。如同我在事先準備的發言中提到的，我們現在已經用新劑型進入臨床，並且會在今年年底前向各位更新進展。

What we would love to see here is that with the new formulation, if we achieve the right exposures that our preclinical data predicted were necessary to see an effect that then we will be able to confirm our conviction that inhibiting V617F in this way with pseudokinase inhibitor, will deliver positive clinical outcomes of patients with MPNs.

我們非常希望看到的是：透過新劑型，如果我們能達到適當的暴露量（exposures），也就是我們的臨床前數據所預測、被認為需要才能看到效果的暴露量，那麼我們就能確認我們的信念——以這種方式用偽激酶（pseudokinase）抑制劑抑制 V617F，將為骨髓增殖性腫瘤（MPNs）患者帶來正向的臨床結果。

So that's basically the goal of the program for this year to deliver enough exposures with the new formulation to achieve concentrations that will hit the target hard enough to show clinical outcomes that matter.

所以這基本上就是今年這個計畫的目標：用新劑型達到足夠的暴露量，取得能夠更有力命中靶點的濃度，從而展現具有意義的臨床結果。

Now when it comes to Prelude, we see that as a next-generation program potentially for us. We have internal next-generation programs, and we have an external next generation program, which is the Prelude 1. That's a time-based option.

至於 Prelude，我們將其視為對我們而言可能的下一代計畫。我們有內部的下一代計畫，也有外部的下一代計畫，也就是 Prelude 1。那是一個以時間為基礎的選擇權。

We'll have to make a decision at some point in time. And that data will be compared with the data from our internal programs as well as the data from the leqad 058, and then we'll make a decision which once we move forward.

我們必須在某個時間點做出決定。屆時會把那邊的數據與我們內部計畫的數據，以及 leqad 058 的數據進行比較，然後我們會做出決定，選擇接下來要推進哪一個。

Mitchell Kapoor from HC Wainwright.

HC Wainwright 的 Mitchell Kapoor。

This is Yan Zhang on for Mitchell Kapoor. Congratulations again on the data. I was curious about povorcitinib in HP. So where do you expect to be earliest uptake to take place?

我是代 Mitchell Kapoor 提問的 Yan Zhang。再次恭喜你們的數據。我想問的是關於 povorcitinib 在 HS 中的應用。你們預期最早的採用會發生在哪裡？

Would you say in biologic naive patients post biologic failures or patients with specific disease features such as like draining tunnels pain or a high inflammatory burden?

你們會認為是在未使用過生物製劑（biologic naive）的患者、生物製劑治療失敗後的患者，或是具有特定疾病特徵的患者，例如引流性瘻道（draining tunnels）、疼痛，或高度發炎負荷？

Yes, Mitchell, thanks for the, or excuse me, Yan thanks for the question. I'll make a few comments and then Mohamed will add. First of all, I would just step back and say that I think the HS market is tailor-made for an oral. This market is set up for sequencing oral to injectables. And that's something that's been missing.

是的，Mitchell，謝謝你的——或不好意思，Yan，謝謝你的提問。我先講幾點，然後 Mohamed 會補充。首先我想退一步說，我認為 HS 市場是為口服藥量身打造的。這個市場的治療序列很適合從口服到注射劑的排序，而這一直是缺失的一環。

Think about all the value that's been ascribed to orals in the obesity market and povo has the potential to be the first oral anti-inflammatory. We expect to have a broad label, both in the pre and post-biologic setting, which I think is a real advantage. 70% of our clinical data is in prebiologic patients.

想想在肥胖市場中，口服藥被賦予了多大的價值，而 povo 有潛力成為第一個口服抗發炎藥。我們預期標籤會很廣，涵蓋生物製劑治療前與治療後的情境，我認為這是很大的優勢。我們的臨床數據有 70% 來自生物製劑治療前（prebiologic）的患者。

As it relates to early uptake, you certainly could envision that patients who are on a biologic right now, one of the 17s are TNF who have active disease or aren't achieving pain relief or have some injection fatigue could be an early source of utilization.

至於早期採用，你當然可以想像：目前正在使用生物製劑的患者——不論是 IL-17 類或 TNF 類——若仍有活動性疾病、未達到疼痛緩解，或對注射產生疲乏（injection fatigue），都可能成為早期使用的來源。

And if you think about the size of the biologic market, there's a range out there in terms of the estimates, it's 50,000 to 75,000 patients. If povorcitinib was to get 10% of 50,000 on an annualized basis, you'd have a couple of hundred million dollars in revenue.

如果你看生物製劑市場的規模，外界估算有一個區間，大約是 5 萬到 7.5 萬名患者。若 povorcitinib 能取得 5 萬人中的 10%，以年化計算，你就會有數億美元的營收。

But I think the most important point here is we expect that we will capture patients at two distinct inflection points after an antibiotic before a biologic. And then after a biologic, whether it's a 17 or TNF alpha.

但我認為最重要的一點是：我們預期會在兩個明確的拐點捕捉患者——在抗生素之後、生物製劑之前；以及在生物製劑之後，不論是 IL-17 或 TNF alpha。

And Mohamed right now is working on preparing that launch. So it is completely wired for success. Mohamed, do you want to add anything?

而 Mohamed 目前正在準備上市工作，所以整體已完全就緒、具備成功條件。Mohamed，你要補充什麼嗎？

Yes. Look, I mean, HS, as we know, is a large and growing market and has a significant unmet need. The disease is debilitating. It's characterized by chronic pain, drainage and flares and obviously, highly heterogeneous, right, with multiple cytokines.

是的。你看，HS 如我們所知，是一個龐大且成長中的市場，且存在顯著未被滿足的需求。這個疾病會造成失能；其特徵是慢性疼痛、滲液（drainage）與反覆發作（flares），而且顯然高度異質，對吧，涉及多種細胞激素。

So when you think about the market, as Bill just described in terms of its size, 300,000 patients in the US, 200,000 actively seeking treatment and yet only 50,000 of them are in advanced therapy.

所以當你思考這個市場，如 Bill 剛才描述的規模：美國約 30 萬名患者，約 20 萬名積極尋求治療，但其中只有 5 萬名在使用進階治療（advanced therapy）。

So povo is positioned to address this market as the first and only oral treatment with biologic-like efficacy across all of the treatment parameters that are quite debilitating and by competing, like Bill mentioned, in both the pre and post-biologic setting, povo has the potential to be somewhere between $500 million to $1 billion in peak sales.

因此，povo 的定位是：作為第一個且唯一的口服治療，具備類生物製劑（biologic-like）的療效，並且在所有相當令人困擾的治療參數上都有效；同時如 Bill 提到的，透過在生物製劑治療前與治療後兩個情境競爭，povo 的峰值銷售潛力可能介於 5 億到 10 億美元之間。

And I think at launch, you can expect an opportunity to capture patients on both sides of that inflection point.

我認為在上市初期，你可以預期有機會在那個拐點的兩側都捕捉到患者。

Srikripa Devarakonda from Truist.

Truist 的 Srikripa Devarakonda。

And congrats on the most recent clinical data as well with povo. I have a question on the rux mutant CALR combo with the first-line data that is expected year-end. Can you remind us of data that suggests any synergistic benefit?

也恭喜你們最近 povo 的臨床數據。我有一個問題是關於 rux 突變型 CALR 聯合治療（combo），以及預計在年底公布的一線（first-line）數據。你能否提醒我們，有哪些數據顯示存在任何協同效益（synergistic benefit）？

And given how well Jakafi is entrenched in the myelofibrosis market, if CALR mutant patients are doing well on Jakafi, where do you envision mutant CALR fitting, like is it a combo? Is it, could it be a switch add-on?

考量到 Jakafi 在骨髓纖維化市場的既有地位，如果 CALR 突變患者在 Jakafi 上表現良好，您如何看待突變型 CALR 的定位？例如會是聯合用藥嗎？還是可能作為切換後的加用（add-on）？

Thank you for the question. So let me offer a couple of points. So let's start with the first part of your question about synergy. Preclinically, we saw additive to synergistic effects combining 989 with Jakafi and CALR mutated models.

謝謝你的問題。我提出幾點說明。先從你問題的第一部分——協同作用——談起。臨床前研究中，我們在 CALR 突變模型裡看到 989 與 Jakafi 合併使用呈現加成到協同的效果。

And I think what's important to remember is, first of all, Jakafi as well as it works and as important as a step forward, it has been in patients with MPNs as particularly in CALR mutated patients, very little, if any, disease modification potential. It controls the symptoms, some of the symptoms of the disease.

我認為重要的是要記住：首先，Jakafi 的確有效，也是 MPN 患者治療上的重要進展；但在 MPN 患者、尤其是 CALR 突變患者中，它幾乎沒有（如果有的話也非常有限）疾病修飾（disease modification）的潛力。它主要是控制症狀，控制疾病的一部分症狀。

Obviously, it leads to spleen responses. All those effects are much less in patients with CALR mutations. In fact, if you look at the control arms of the COMFORT studies or the MANIFEST study, the SVR35 and Jakafi in CALR-mutated patients is approximately 20%. That's in previously untreated patients.

顯然，它能帶來脾臟反應。但這些效果在 CALR 突變患者中要弱得多。事實上，如果你看 COMFORT 研究或 MANIFEST 研究的對照組，CALR 突變患者使用 Jakafi 的 SVR35 大約是 20%。那是在先前未治療的患者中。

So obviously, there's a need for something better for CALR mutated patients even in first-line MF. The second part of the question is Jakafi does have a package, which is obviously produces a fair amount of anemia and thrombocytopenia.

所以很明顯，即使在一線 MF（骨髓纖維化）治療中，CALR 突變患者也需要更好的方案。問題的第二部分是，Jakafi 的安全性特徵（package）也很明顯，會造成相當程度的貧血與血小板減少。

So what we're looking to do with 989 is fundamentally different. We're looking to restore normal hematopoesis. We're looking to eliminate malignant megakaryocytes from the bone marrow.

因此，我們用 989 想做的是根本不同的事情。我們希望恢復正常造血。我們希望從骨髓中清除惡性巨核細胞。

We're looking to eliminate CD34 positive mutant CALR positive cells from peripheral blood. And as a result of that shift back to normal hematopoiesis, which as we've seen already, translates into improvements in anemia as well as spleen responses and symptom improvement.

我們希望清除周邊血中的 CD34 陽性、突變 CALR 陽性細胞。隨著造血回到正常的轉變——我們已經看到——可轉化為貧血改善、脾臟反應以及症狀改善。

So when we put this whole package together, we'll show you the data by the end of the year in a larger group of first-line patients, we will have for you a regulatory strategy for 989 in first-line MF. But we think that the effect of 989 and Jakafi are fundamentally different in this patient population.

把整個組合放在一起看，我們會在今年年底前向各位展示一線患者更大樣本群的數據；同時，我們也會提出 989 用於一線 MF 的法規（監管）策略。但我們認為，在這個患者族群中，989 與 Jakafi 的作用機制與效果是根本不同的。

Brian Abrahams from RBC Capital Markets.

RBC Capital Markets 的 Brian Abrahams。

Sounds like you've made a lot of progress with the 989 subcu form, having completed the healthy volunteer study. So I guess I was wondering if you could maybe tell us about the observations there.

聽起來你們在 989 的皮下（subcu）劑型方面進展很大，已完成健康受試者研究。所以我想請教，你們能否談談那項研究中的觀察結果？

And then the scope and dose range that you're going to be testing in this ongoing Phase 1 study in patients and whether that in and of itself could potentially be bridging or whether you'll need integration of the subcu form into the Phase 3?

另外，你們在這項進行中的第一期患者研究中，將測試的範圍與劑量區間是什麼？以及僅憑這些是否可能作為橋接（bridging），或是你們需要把皮下劑型整合進第三期？

Thanks for the question, Brian. Pablo?

謝謝你的問題，Brian。Pablo？

So the data from the healthy volunteer study, as I mentioned in my remarks, has allowed us now to move very quickly into patients. We're going to test a very broad range of doses.

健康受試者研究的數據，如我在發言中提到的，讓我們現在能非常快速地推進到患者研究。我們將測試非常廣泛的劑量範圍。

Let me just assure you that they will cover all the potential doses that we're using in Phase 3 in ET and that we could conceivably use in Phase 3 in patients with MF. So we will have that covered. In terms of implementing this in Phase 3 studies, this is a question of timing, Brian.

我可以向你保證，這些劑量會涵蓋我們在 ET 第三期所使用的所有可能劑量，也會涵蓋我們在 MF 第三期患者中可能使用的劑量。因此這部分我們會覆蓋到。至於在第三期研究中如何導入，這取決於時程，Brian。

Speed is really important here. We need to bring this medicine to market for patients with ET and MF as quickly as possible. We will not slow down the ET study.

速度在這裡非常重要。我們需要盡快把這個藥帶到市場，提供給 ET 與 MF 的患者。我們不會放慢 ET 研究。

We're probably not going to slow down the second-line MF study to incorporate the subcu, and we'll have a bridging strategy at the back end, our goal is to incorporate a subcu formulation in the first line MF study. And right now, the plan allows us to do that. We'll provide an update on both before the end of the year.

我們大概也不會放慢二線 MF 研究來納入皮下劑型；我們會在後端採取橋接策略。我們的目標是在一線 MF 研究中納入皮下劑型，而目前的計畫允許我們做到這點。我們會在今年年底前就兩者提供更新。

Jessica Fye from JP Morgan.

JP Morgan 的 Jessica Fye。

I had another one on 989. I was hoping you could touch on the potential translatability of the ET design to MF as it relates to starting dose.

我還有一個關於 989 的問題。我希望你能談談 ET 的試驗設計在 MF 上的可轉譯性，特別是與起始劑量相關的部分。

And I guess really more specifically the potential for an up-titration approach particularly in the context of a potential six month primary endpoint where we're presumably going to be looking at SVR35 and TSS50 versus looking for an early platelet response like in ET?

更具體地說，在可能以六個月作為主要終點的情境下——我們推測會看 SVR35 與 TSS50——相較於 ET 會看早期血小板反應，你們是否可能採用逐步上調劑量（up-titration）的策略？

Thank you for the question, Jess. So the journey in MF is just a little bit earlier. We need to spend a little bit more time with FDA discussing the design of the second-line MF study. So I'm going to be a little bit less open about answering the question in detail.

謝謝你的問題，Jess。MF 的進程還稍微早一些。我們需要花更多時間與 FDA 討論二線 MF 研究的設計。因此我在細節上會比較保留。

Now I think that the fact that we have an agreement on the potential for, the potential on the step-up escalation in ET certainly can build, we can build the framework around that in MF.

不過，我認為我們已就 ET 的逐步加量（step-up escalation）可能性達成一致，這確實能讓我們在 MF 上建立相應的框架。

I think the more important thing in MF to be honest, is to have a constructive dialogue with the agency on the primary endpoint of the study, which we intend to do and for which we have a lot of supporting data.

坦白說，我認為在 MF 更重要的是，與主管機關就研究的主要終點進行建設性的對話；我們打算這麼做，而且我們有大量支持性數據。

As I mentioned in an answer to a previous question, 989 is a fundamentally different type of medicine for patients with MF. This is about normalizing hematopoiesis not just a nonspecific inhibition of JAK that leads to some symptom improvement and spleen response.

如我在回答先前問題時提到的，989 對 MF 患者而言是一種根本不同類型的藥物。這是關於使造血正常化，而不只是對 JAK 的非特異性抑制——那種抑制會帶來一些症狀改善與脾臟反應。

It's about normalizing hematopoiesis. We think that needs to be contemplated into the primary endpoint for the study in MF, and we intend to have that conversation with FDA.

這是關於使造血正常化。我們認為這需要被納入 MF 研究的主要終點考量中，而我們也打算與 FDA 進行這樣的討論。

Conceivably, we could have the same to address the heterogeneity across the population, we could have a dose escalation step as well. In this case, it could take a little bit longer, but we'll have that conversation with the FDA at the right time.

理論上，為了因應族群間的異質性，我們也可能採用類似的劑量遞增步驟。在這種情況下，可能會花更長時間，但我們會在適當時機與 FDA 討論。

Thanks, Jess. Congratulations on the move to Morgan Stanley.

謝謝你，Jess。恭喜你轉到 Morgan Stanley。

Derek Archila from Wells Fargo.

Wells Fargo 的 Derek Archila。

Congrats on the progress. This one is for Pablo. If you frame the setup for EHA and the update there earlier, but I guess, is the expectation we should see deepening responses in these MF cohorts at the update I just wanted to reconcile the eradication comment that you made.

恭喜你們的進展。這題給 Pablo。你先前提到 EHA 的安排與更新，但我想問的是：在這次更新中，我們是否預期會看到這些 MF 隊列的反應進一步加深？我想把這點與你提到的「清除」評論對照起來理解。

So it's always, look, we will have data that continues to show the effect of 989 as a disease-modifying therapy. And that consistently will show that we can continue to eliminate, dramatically reduce in some patients close to eliminate the malignant population of megakaryocytes in the bone marrow and in peripheral blood. And you should see more of the translational data at EHA.

所以，一直都是這樣——你看，我們會有持續的數據來顯示 989 作為疾病修飾療法的效果。而且會一致地顯示：我們能持續清除、在部分患者中大幅降低、接近清除骨髓以及周邊血中的惡性巨核細胞族群。你們在 EHA 會看到更多轉譯研究數據。

We reached the end of our question-and-answer session. Ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.

我們的問答環節到此結束。各位女士、先生，今天的電話會議與網路直播也到此結束。您現在可以掛線，祝您有美好的一天。感謝各位今天的參與。