英賽德 (INCY) 2025 Q4 法說會逐字稿

Greetings, and welcome to the Incyte fourth-quarter and year-end 2025 financial results conference call and Webcast. (Operator Instructions) As a reminder, this conference is being recorded. (Operator Instructions)

大家好，歡迎參加 Incyte 2025 年第四季及全年財務業績電話會議和網路直播。（操作說明）提醒各位，本次會議正在錄音。（操作說明）

It's now my pleasure to turn the call over to your host, Alexis Smith, Vice President, Investor Relations. Please go ahead.

現在我很高興將電話交給主持人，投資人關係副總裁 Alexis Smith。請繼續。

Thank you. Good morning, and welcome to Incyte's fourth-quarter and full year 2025 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。早安，歡迎參加 Incyte 2025 年第四季及全年業績電話會議。在開始之前，我鼓勵大家造訪我們網站的「投資者」版塊，尋找新聞稿、相關財務表格以及今天討論之後要使用的幻燈片。

On today's call, I'm joined by Bill, Pablo, and Tom, who will deliver our prepared remarks. Steven, Dave, Matteo, 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.

今天，比爾、帕布羅和湯姆將與我一起參加電話會議，他們將分別發表我們準備好的演講。Steven、Dave、Matteo 和 Mohamed 也將參加今天電話會議的問答環節。我想指出，我們將做出一些前瞻性聲明，這些聲明是基於我們目前的預期和信念。

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. I will now hand the call over to Bill.

這些聲明存在一定的風險和不確定性，我們的實際結果可能與此有重大差異。我建議您查閱我們在提交給美國證券交易委員會的文件中討論的風險因素，以了解更多詳情。現在我將把電話交給比爾。

Alexis, thank you, and good morning, everyone. I'll cover two topics today. First, I'll give an overview of our performance in 2025, then I'll turn to our outlook for 2026 and beyond and the steps we're taking with our core business and pipeline to transition Incyte. As I touched on at JPM, there are several achievements in 2025 that stand out. First, our business exceeded expectations on three levels: total sales, Jakafi sales and our core business sales ex-Jakafi.

Alexis，謝謝你，大家早安。今天我將講解兩個主題。首先，我將概述我們在 2025 年的業績，然後我將展望 2026 年及以後的發展前景，以及我們正在採取哪些措施，透過我們的核心業務和產品線來實現 Incyte 的轉型。正如我在摩根大通提到的那樣，2025 年有幾項成就特別突出。首先，我們的業務在三個層面上都超出了預期：總銷售額、Jakafi 銷售額以及剔除 Jakafi 後的核心業務銷售額。

Second, we fundamentally changed the shape and maturity of our pipeline. We moved multiple assets from early to late-stage development. We now have several outlier opportunities for the treatment of MPNs, pancreatic cancer, colorectal cancer and HS that have the potential to drive revenue, earnings, and cash flow into the next decade.

其次，我們從根本上改變了我們產品線的形態和成熟度。我們將多個專案從早期開發階段轉移到了後期開發階段。我們現在在治療 MPN、胰腺癌、大腸癌和 HS 方面擁有幾個獨特的機遇，這些機會有可能在未來十年推動收入、利潤和現金流的成長。

Finally, regulatory applications for Jakafi XR, Opzelura for moderate AD and povorcitinib for HS in Europe were submitted on a timely basis. The point here is we have much greater visibility into the potential growth profile of the company now than we did at the start of 2025. Everything we accomplished this past year commercially, scientifically, and operationally has created the foundation for an inflection point in '26 and beyond.

最後，Jakafi XR、用於治療中度 AD 的 Opzelura 和用於治療 HS 的 povorcitinib 在歐洲的監管申請已按時提交。關鍵在於，與 2025 年初相比，我們現在對公司的潛在成長前景有了更清晰的了解。我們在過去一年在商業、科學和營運方面所取得的一切成就，為 2026 年及以後的轉折點奠定了基礎。

Now I'll speak to our performance in '25 and the outlook. for '26. Turning to revenue. The business performed exceptionally well this past year. Revenues in the fourth-quarter totalled $1.51 billion, up 28% versus the prior year. For full year '25, revenue totalled $5.14 billion, up 21% year-over-year. This was driven by strong commercial performance and an increase in milestone and contract revenue.

現在我將談談我們在2025年的表現以及對2026年的展望。轉向營收。過去一年，公司業績表現異常出色。第四季營收總計15.1億美元，較上年同期成長28%。2025 年全年營收總計 51.4 億美元，年增 21%。這主要得益於強勁的商業表現以及里程碑和合約收入的成長。

Net sales in the fourth-quarter totalled $1.22 billion, representing a 20% increase versus the prior year. For full year '25, net sales were $4.35 billion, also up 20% year-over-year, exceeding both expectations and our guidance. Growth was broad-based with nearly every product contributing meaningfully.

第四季淨銷售額總計 12.2 億美元，比上年同期成長 20%。2025 年全年淨銷售額為 43.5 億美元，年增 20%，超出預期和我們的指導。成長基礎廣泛，幾乎每款產品都做出了顯著貢獻。

Focusing on our core business ex-Jakafi, sales totalled $1.26 billion, representing over $400 million in growth and a 53% increase versus 2024. Opzelura, NiktimVo and Monjuvi were the largest absolute growth contributors. This core business is expected to grow over 30% in '26 and has the potential to grow at a 15% to 20% five-year CAGR and approach $3 billion to $4 billion by 2030. Now a few comments about the key products, Jakafi, Opzelura and our hematology and oncology products.

除 Jakafi 外，我們的核心業務銷售額總計 12.6 億美元，比 2024 年增長超過 4 億美元，增幅達 53%。Opzelura、NiktimVo 和 Monjuvi 是最大的絕對成長貢獻者。預計該核心業務在 2026 年將成長超過 30%，並有可能在未來五年內以 15% 至 20% 的複合年增長率成長，到 2030 年將接近 30 億至 40 億美元。現在就主要產品 Jakafi、Opzelura 以及我們的血液腫瘤產品做一些說明。

Starting with Jakafi on slide 9. fourth-quarter and full year sales exceeded expectations. In the fourth-quarter, sales were $828 million, an increase of 7% versus prior year. Full year sales totalled $3.093 billion, representing an 11% increase year-over-year. Jakafi remains an integral part of our business and keeping it healthy is a priority. It continues to serve as a funding source for our pipeline and for future product launches.

從幻燈片 9 中的 Jakafi 開始，第四季度和全年銷售額均超出預期。第四季銷售額為 8.28 億美元，比上年同期成長 7%。全年銷售額達 30.93 億美元，年增 11%。Jakafi 仍然是我們業務不可或缺的一部分，保持其健康發展是我們的首要任務。它將繼續作為我們研發管線和未來產品發布的資金來源。

A few comments on the fundamentals of this business. First, prescriptions increased 11% in the fourth-quarter and 9% for the full year 2025, despite a growing base and competition. Second, demand was up across all three indications. PV will be the largest and fastest-growing indication in '26. And with a penetration rate of only 30% versus 60% to 70% in frontline MF, it should be a reliable and significant source of growth going forward. And finally, formulary coverage for Jakafi remains excellent with near complete coverage across plans.

關於這項業務的基本情況，我有幾點要說明。首先，儘管基數不斷擴大且競爭日益激烈，但第四季度處方量仍增加了 11%，2025 年全年處方量增加了 9%。其次，這三個適應症的需求均上升。PV 將成為 2026 年規模最大、成長最快的適應症。而目前該類產品的滲透率僅為 30%，遠低於第一線共同基金的 60% 至 70%，因此它應該會成為未來可靠且重要的成長來源。最後，Jakafi 的藥品覆蓋範圍依然非常出色，幾乎所有計劃都涵蓋了所有藥品。

In '26, we expect net sales to be $3.22 billion to $3.27 billion. Prescriptions are expected to grow at a high single-digit rate, representing mid-single-digit sales growth compared to 2025. In terms of Jakafi XR, we expect to receive an approval and launch in the middle of '26. Given this timing, the second half of the year will be mostly about formulary access and '27 will be focused on conversion. We'll share more about our launch plans in future calls.

預計 2026 年淨銷售額將達到 32.2 億至 32.7 億美元。預計處方藥數量將以接近兩位數的速度成長，與 2025 年相比，銷售額將實現中等個位數的成長。關於 Jakafi XR，我們預計將於 2026 年年中獲得批准並推出。鑑於此時間安排，今年下半年將主要關注藥品目錄准入，而 2027 年將重點放在轉換率上。我們將在以後的電話會議中分享更多關於我們發布計劃的資訊。

Now I'll turn to slide 10 for Opzelura. Net sales in the fourth-quarter totalled $207 million, an increase of 28% and full year net sales were $678 million, up 33% versus 2024. Growth was driven by increased penetration in the US AD and vitiligo markets, where Opzelura prescriptions climbed 24% and 15%, respectively.

現在我來看看 Opzelura 的第 10 張幻燈片。第四季淨銷售額總計 2.07 億美元，成長 28%；全年淨銷售額為 6.78 億美元，比 2024 年成長 33%。成長的驅動力是在美國 AD 和白斑市場滲透率的提高，Opzelura 的處方量分別成長了 24% 和 15%。

The pediatric launch for Opzelura AD is off to a strong start in the United States with sales already annualizing around $30 million. Both dermatologists and parents are increasingly seeking non-steroidal options for atopic dermatitis, driven by concerns about long-term steroid use. International sales for Opzelura in vitiligo doubled to $130 million in 2025. In '26, we expect sales of $750 million to $790 million, representing roughly a 15% increase at the midpoint.

Opzelura AD 在美國的兒科市場取得了強勁的開局，年銷售額已達到約 3000 萬美元。由於擔心長期使用類固醇藥物，皮膚科醫生和家長都越來越傾向於尋找非類固醇類藥物來治療異位性皮膚炎。Opzelura治療白斑症的國際銷售額預計在2025年翻一番，達到1.3億美元。2026 年，我們預計銷售額為 7.5 億美元至 7.9 億美元，中位數約為 15%。

This estimate is based primarily on continued double-digit volume growth in the United States for AD and vitiligo, partially offset by price actions to expand formulary coverage as well as sustained double-digit growth internationally off of a larger base as we lap the strong full year launch for vitiligo in Europe. Most of the benefits of the moderate AD launch in Europe in the second half of this year are expected in '27 and beyond.

這項估計主要基於美國 AD 和白斑症銷售持續兩位數增長，部分被擴大處方集覆蓋範圍的價格措施所抵消，以及由於歐洲白癜風產品強勁的全年上市，國際市場在更大基數上持續兩位數增長。今年下半年在歐洲適度推出防盜技術的大部分益處預計將在 2027 年及以後顯現。

As I've said, our aim long term is to nearly double the size of this business. The nonsteroidal segment of the AD market is growing 20% year-over-year, creating a significant tailwind as prescribing migrates from topical steroids to nonsteroid options. We still have a modest share of each of those segments, so there is substantial headroom for growth. In addition to this, our international business and new indications will serve as meaningful catalysts for the next phase of expansion.

正如我所說，我們的長期目標是將這家公司的規模擴大近一倍。AD市場中非類固醇類藥物部分正以每年20%的速度成長，隨著處方從局部類固醇轉向非類固醇類藥物，這帶來了顯著的順風。我們目前在這些細分市場仍佔有較小的份額，因此還有很大的成長空間。除此之外，我們的國際業務和新的適應症將成為下一階段擴張的重要催化劑。

And now on slide 11, we'll turn to our hematology and oncology products. Net product sales in the fourth-quarter were $187 million, up 121% compared to prior year. Full year '25 sales were $583 million, representing an 83% increase compared to 2024, driven by Niktimvo, Monjuvi and Zynyz. Niktimvo finished its first year at $152 million. We achieved broad penetration and deep utilization of BMT centers, and we've reached more than 1,400 patients with 13,000 infusions.

現在，在第 11 張投影片中，我們將介紹我們的血液學和腫瘤學產品。第四季淨產品銷售額為 1.87 億美元，比上年同期成長 121%。2025 年全年銷售額為 5.83 億美元，比 2024 年成長 83%，主要得益於 Niktimvo、Monjuvi 和 Zynyz 的推動。Niktimvo 成立第一年的收入為 1.52 億美元。我們實現了骨髓移植中心的廣泛滲透和深度利用，已為超過 1400 名患者進行了 13000 次輸注。

In line with expectations, Niktimvo is being used widely in the fourth-line setting with increasing preference in the third line. As it relates to Monjuvi, sales were up 20% versus prior year based on a strong launch in follicular lymphoma in the middle of 2025.

正如預期的那樣，Niktimvo 在第四線治療中被廣泛使用，並且在第三線治療中越來越受歡迎。就 Monjuvi 而言，由於 2025 年年中在濾泡性淋巴瘤領域強勁上市，其銷售額比上年增長了 20%。

As you know, we released data in January in frontline DLBCL, where Monjuvi plus lenalidomide showed a 25% improvement in PFS, improving on R-CHOP chemotherapy which is a regimen that still accounts for 50% of the first-line DLBCL market. This year, we plan to present the data at an upcoming medical meeting, work to incorporate Monjuvi into appropriate guidelines and submit an sBLA in the first half with the potential FDA approval by early '27.

如您所知，我們在 1 月發布了一線 DLBCL 的數據，其中 Monjuvi 加來那度胺治療使 PFS 提高了 25%，優於 R-CHOP 化療，而 R-CHOP 化療目前仍佔一線 DLBCL 市場的 50%。今年，我們計劃在即將舉行的醫學會議上公佈數據，努力將 Monjuvi 納入相應的指南，並在上半年提交補充生物製品許可申請 (sBLA)，爭取在 2027 年初獲得 FDA 批准。

Looking ahead, we've set our full year guidance for the hematology and oncology business at $800 million to $880 million for the year, representing approximately a 40% to 50% increase compared to our performance in '25. Now three takeaways about '26 that I'd like to reinforce before turning over the call to Pablo. First, our core business, excluding Jakafi, has the potential to be as large as Jakafi is today by 2030. A key part of that growth will come from product launches we expect late this year and early '27.

展望未來，我們已將血液腫瘤業務的全年業績預期設定為 8 億美元至 8.8 億美元，與 2025 年的業績相比，增長約 40% 至 50%。現在，關於 2026 年，我想在把電話交給 Pablo 之前，強調三點。首先，到 2030 年，我們的核心業務（不包括 Jakafi）有可能達到 Jakafi 目前的規模。這一成長的關鍵部分將來自我們預計在今年稍後和 2027 年初推出的產品。

I mentioned XR, Opzelura and Monjuvi earlier, so I want to make a few comments about where we are with povorcitinib. The NDA for povorcitinib in HS has been submitted, and we anticipate filing acceptance this quarter.

我之前提到了 XR、Opzelura 和 Monjuvi，所以我想就 povorcitinib 的現狀發表一些看法。針對化膿性汗腺炎的 povorcitinib 新藥申請已提交，我們預計本季將收到受理通知。

As you know, HS is the first of potentially three indications, the others being PN and vitiligo. Povo has the potential to be the first FDA-approved oral treatment for HS. Here, we have an opportunity to capture patients at two critical inflection points.

如您所知，HS 是三種潛在適應症中的第一種，其他兩種是 PN 和白斑症。Povo 有可能成為第一個獲得 FDA 批准的用於治療化膿性汗腺炎的口服藥物。在這裡，我們有機會在兩個關鍵轉折點捕捉到患者的情況。

First, in the pre-biologic setting, a population with no FDA-approved treatments today. These patients are cycling through antibiotics and steroids that don't address the underlying disease biology. Second, in the post-biologic setting where IL-17s and TNFs are used, but where partial responses are common. An effective oral option could be transformative in both treatment settings. We will talk more about launch plans in future calls.

首先，在生物製劑出現之前，目前還沒有獲得 FDA 批准的治療方法。這些患者不斷接受抗生素和類固醇治療，但這些藥物並不能解決疾病的根本生物學問題。其次，在生物治療後，IL-17 和 TNF 被使用，但部分療效較常見。有效的口服治療方案可能在兩種治療環境中都帶來改變。我們將在以後的電話會議中詳細討論發布計劃。

Second, our pipeline has the breadth and depth to support top-tier growth and the potential of 2 to 3x our top line over time. In '26 alone, we will have 14 pivotal trials underway across seven assets by end of the year and multiple data catalysts. Pablo will walk through the status of our key programs and the potential to double our business over time.

其次，我們的產品線具有足夠的廣度和深度，能夠支援一流的成長，並且隨著時間的推移，有可能使我們的收入成長 2 到 3 倍。僅在 2026 年，到年底我們將有 14 項關鍵試驗在 7 個資產上進行，並且有多個數據催化劑。Pablo 將詳細介紹我們關鍵專案的進展情況，以及隨著時間的推移，我們業務翻倍的潛力。

And finally, we view BD as a multiplier, a way to extend and strengthen the core. We have the capacity to pursue a broad range of opportunities. Ultimately, the size and nature of any deal will be dictated by strategic fit and the potential for durable revenue, earnings, and cash flow.

最後，我們將 BD 視為一種倍增器，一種擴展和加強核心的方法。我們有能力把握各種各樣的機會。最終，任何交易的規模和性質都將取決於策略契合度以及持續收入、獲利和現金流的潛力。

Now I'll hand it over to Pablo.

現在我把它交給巴布羅。

Thank you, Bill, and good morning, everyone. As Bill mentioned earlier, in 2025, the pipeline reached a new level of breadth and maturity, setting up a materially different outlook for the company going forward.

謝謝你，比爾，大家早安。正如比爾之前提到的，到 2025 年，管道的廣度和成熟度將達到一個新的水平，為公司未來的發展前景奠定了實質的不同基礎。

First, our approved portfolio and regulatory footprint broadened with approvals for Monjuvi in follicular lymphoma, Zynyz in squamous cell anal carcinoma and Opzelura in pediatric atopic dermatitis, alongside regulatory submissions for Jakafi XR, Opzelura and povorcitinib.

首先，隨著 Monjuvi（用於治療濾泡性淋巴瘤）、Zynyz（用於治療鱗狀細胞肛門癌）和 Opzelura（用於治療兒童異位性皮膚炎）獲得批准，我們的獲批產品組合和監管範圍擴大，同時也提交了 Jakafi XR、Opzelura 和 povorcitinib 的監管申請。

Second, positive clinical data meaningfully advanced multiple programs, including Phase III registrational data for povorcitinib in hidradenitis suppurativa or HS, and early-stage results supporting pivotal development for the mutant CALR program in MF/ET, KRAS G12D in pancreatic cancer and TGF-beta receptor 2 by PD-1 bispecific in MSS colorectal cancer.

其次，積極的臨床數據顯著推進了多個項目，包括 povorcitinib 治療化膿性汗腺炎 (HS) 的 III 期註冊數據，以及支持 MF/ET 突變 CALR 項目、胰腺癌 KRAS G12D 項目和 MSS 結直腸癌 PD-1 雙特異性 TGF-β 受體 2 項目關鍵性開發的早期結果。

In 2026, we will continue to build on this momentum through additional approvals, regulatory filings, pivotal data readouts and trial initiations. For our late-stage pipeline, we anticipate FDA filing acceptance for povorcitinib in HS this quarter, and we plan to submit an sBLA for tafasitamab in first-line DLBCL in the first half of 2026. With the submissions underway, we expect the potential approval and launch of four products in late 2026 and early 2027.

2026年，我們將繼續保持這一勢頭，透過獲得更多批准、提交監管文件、公佈關鍵數據和啟動試驗來實現這一目標。對於我們的後期研發管線，我們預計本季 FDA 將接受 povorcitinib 用於治療 HS 的申請，並計劃在 2026 年上半年提交 tafasitamab 用於一線 DLBCL 的補充生物製品許可申請 (sBLA)。隨著提交工作的進行，我們預計四款產品可能會在 2026 年底和 2027 年初獲得批准並上市。

The emphasis in '26 shifts to advancement across the portfolio as we expect seven data readouts this year, including the positive tafasitamab data already shared in January and 14 pivotal trials underway across hematology, oncology and immunology by year-end. Together, this reflects a pipeline that is increasingly focused, more mature and positioned to translate scientific progress into meaningful impact and long-term value creation.

2026 年的重點轉向推進整個產品組合，我們預計今年將公佈 7 項數據，包括 1 月份已分享的 tafasitamab 的積極數據，以及到年底在血液學、腫瘤學和免疫學領域進行的 14 項關鍵試驗。總而言之，這反映出一條日益聚焦、更加成熟且更有能力將科學進步轉化為有意義的影響和長期價值創造的研發管線。

Our hematology portfolio balances two priorities: expanding the addressable market of established products such as tafasitamab across the full spectrum of B-cell lymphomas and axatilimab in graft-versus-host disease and advancing novel therapies in myeloproliferative neoplasms via our MPN portfolio of targeted therapies.

我們的血液疾病產品組合兼顧兩大優先事項：一是擴大已上市產品（如 tafasitamab 可治療所有 B 細胞淋巴瘤，axatilimab 可治療移植物抗宿主病）的目標市場；二是推進骨髓增生性腫瘤的新療法，透過我們的 MPN 靶向治療產品組合實現這一目標。

In GvHD, we're advancing Niktimvo in two first-line studies evaluating it in combination with ruxolitinib as well as in combination with steroids. Data from these trials are expected in early 2027 and early 2028, respectively.

在 GvHD 方面，我們正在推進 Niktimvo 的兩項第一線研究，評估其與 ruxolitinib 聯合用藥以及與類固醇聯合用藥的療效。預計這些試驗的數據將分別於 2027 年初和 2028 年初公佈。

Our MPN pipeline remains a key area of focus where we're advancing three targeted therapies: 989, our mutant CALR monoclonal antibody; 784, our mutant CALRxCD3 bispecific antibody; and 058, our JAK2 V617F small molecule inhibitor. Each of these programs is designed to address a well-defined disease driver with the potential for disease-modifying activity and the opportunity to fundamentally change how MPNs are treated.

我們的 MPN 研發管線仍然是重點領域，我們正在推進三種標靶療法：989，我們的突變 CALR 單株抗體；784，我們的突變 CALRxCD3 雙特異性抗體；以及 058，我們的 JAK2 V617F 小分子抑制劑。這些計畫旨在解決一個明確的疾病驅動因素，具有改變疾病的潛力，並有機會從根本上改變 MPN 的治療方式。

Looking ahead to upcoming milestones, we expect to report Phase I data for 058 in the second half of this year and Phase I data for 784 in 2027.

展望即將到來的里程碑，我們預計將在今年下半年公佈 058 的第一階段數據，並在 2027 年公佈 784 的第一階段數據。

With that context, I would like to turn to slide 17 to review our progress with 989 and the breadth of development efforts for this program. As a reminder, last year, we presented Phase I data evaluating 989 in CALR-positive patients with essential thrombocythemia and myelofibrosis. The data presented at EHA and ASH in 2025 reinforce the potential of our approach to directly target the oncogenic driver mutation, addressing both the underlying disease and key clinical manifestations.

有鑑於此，我想翻到第 17 張投影片，回顧我們在 989 專案上的進展以及該專案開發工作的廣度。提醒一下，去年我們公佈了 I 期數據，評估了 CALR 陽性原發性血小板增多症和骨髓纖維化患者的 989 例患者。2025 年 EHA 和 ASH 上發表的數據強化了我們直接針對致癌驅動突變的方法的潛力，從而既能解決潛在疾病，又能解決關鍵臨床表現。

Importantly, the proof-of-concept results provide a strong foundation to advance 989 into pivotal Phase III development. We expect to initiate our Phase III trial evaluating 989 in second-line CALR-positive ET patients in mid-2026, following regulatory alignment in the first-quarter.

重要的是，概念驗證結果為推進 989 進入關鍵的 III 期開發奠定了堅實的基礎。我們預計將於 2026 年中啟動 III 期試驗，評估 989 例二線 CALR 陽性 ET 患者的療效，此前我們將在第一季獲得監管部門的批准。

Turning to myelofibrosis. We expect to initiate a Phase III trial in second-line MF in the second half of 2026, following regulatory alignment midyear. In parallel, we continue to advance our ongoing Phase I study, which is enrolling second-line ET, second-line MF and first-line MF cohorts. We plan to share updated data in second-line ET and second-line

轉而討論骨髓纖維化。我們預計將在 2026 年下半年啟動針對二線 MF 的 III 期試驗，前提是年中獲得監管部門的批准。同時，我們正在繼續進行正在進行的 I 期研究，該研究正在招募二線 ET 患者、二線 MF 患者和第一線 MF 患者。我們計劃分享二線ET和二線更新數據

MF midyear and new data from our cohort evaluating 989 as a monotherapy and in combination with ruxolitinib as a first-line therapy in the second half of 2026.

MF2026 年下半年，我們將公佈 989 作為單藥療法以及與魯索替尼聯合作為一線療法的隊列研究的年中和新數據。

Finally, we're advancing a subcutaneous formulation of 989. We aligned with the FDA on this development strategy last month, and we plan to initiate a Phase I study during the first-quarter of 2026. In December, tafasitamab was approved in both Europe and Japan in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma following at least one prior line of systemic therapy, further expanding its global footprint.

最後，我們正在推動 989 的皮下製劑的研發。上個月，我們與 FDA 就此開發策略達成一致，我們計劃在 2026 年第一季啟動 I 期研究。12 月，tafasitamab 與來那度胺和利妥昔單抗聯合用於治療至少接受過一線全身治療後復發或難治性濾泡性淋巴瘤的成年患者，在歐洲和日本獲得批准，進一步擴大了其全球應用範圍。

In January, we reported positive top line results from the pivotal Phase III frontMIND trial, which evaluated tafasitamab and lenalidomide in combination with R-CHOP as a first-line treatment for newly diagnosed high-grade DLBCL with IPI of three to five.

1 月，我們公佈了關鍵性 III 期 frontMIND 試驗的積極初步結果，該試驗評估了 tafasitamab 和 lenalidomide 聯合 R-CHOP 作為 IPI 為 3 至 5 的新診斷高級別 DLBCL 的一線治療方案。

The study met its primary endpoint of progression-free survival and achieved its key secondary endpoint of event-free survival by investigator assessment with no new safety signals observed. We plan to present additional data from the frontline study, including overall survival and subgroup analysis at an upcoming medical congress this year. Based on these results, the sBLA for first-line DLBCL remains on track for submission in the first half of 2026. If approved, Monjuvi has the potential to address the full spectrum of B-cell lymphomas.

該研究達到了無惡化存活期的主要終點，並達到了研究者評估的無事件存活期的關鍵次要終點，且未觀察到新的安全性訊號。我們計劃在今年即將舉行的醫學大會上公佈更多一線研究的數據，包括總存活期和亞組分析。根據這些結果，第一線治療瀰漫性大B細胞淋巴瘤的補充生物製品許可申請（sBLA）仍有望在2026年上半年提交。如果獲得批准，Monjuvi 有望治療所有類型的 B 細胞淋巴瘤。

Turning now to oncology. Our oncology portfolio focuses on advancing novel therapies that target well-validated but historically difficult pathways in high incidence cancers, including colorectal, pancreatic, and ovarian cancer. Starting with 890, our first-in-class TGF-beta receptor 2 by PD-1 bispecific antibody. Based on data we presented at ESMO and following alignment with the FDA, we initiated a Phase III study in December, evaluating 890 in combination with FOLFOX and bevacizumab compared to placebo in combination with FOLFOX bevacizumab in first-line MSS colorectal cancer patients.

接下來我們來談談腫瘤學。我們的腫瘤產品組合專注於推動針對高發生率癌症（包括大腸癌、胰臟癌和卵巢癌）中經過充分驗證但歷史上難以治療的路徑的新型療法。從 890 開始，這是我們首款 TGF-β 受體 2 與 PD-1 雙特異性抗體。根據我們在 ESMO 上公佈的數據，並與 FDA 達成協議後，我們在 12 月啟動了一項 III 期研究，評估 890 聯合 FOLFOX 和貝伐單抗與安慰劑聯合 FOLFOX 和貝伐單抗治療一線 MSS 結直腸癌患者的療效。

Next, 667, our CDK2 inhibitor, is being evaluated in patients with platinum-resistant ovarian cancer with cyclin E1 overexpression, a biomarker-defined population with significant medical need. The MAESTRO clinical program consists of two ongoing trials, a Phase II single-arm study and a Phase III study versus investigator's choice chemotherapy as well as a planned Phase III study evaluating 667 in the first-line maintenance setting in combination with bevacizumab.

接下來，我們的 CDK2 抑制劑 667 正在對鉑抗藥性卵巢癌且細胞週期蛋白 E1 過度表現的患者進行評估，這是由生物標記定義的具有重大醫療需求的群體。MAESTRO 臨床計畫包括兩項正在進行的試驗，一項 II 期單臂研究和一項 III 期研究，與研究者選擇的化療進行比較；以及一項計劃中的 III 期研究，評估 667 在一線維持治療中與貝伐單抗聯合應用的療效。

734 is a highly selective KRAS G12D inhibitor that has demonstrated promising antitumor activity in G12D mutated solid tumors, including pancreatic ductal adenocarcinoma or PDAC. Last month, at ASCO GI, we presented new efficacy and safety data evaluating 734, both as a monotherapy and in combination regimens in patients with PDAC.

734 是一種高選擇性 KRAS G12D 抑制劑，已在 G12D 突變的實體瘤（包括胰腺導管腺癌或 PDAC）中顯示出良好的抗腫瘤活性。上個月，在 ASCO GI 會議上，我們公佈了評估 734 作為單藥療法和聯合療法治療 PDAC 患者療效和安全性的新數據。

At the planned Phase III dose of 200 milligrams a day, 734 as a monotherapy demonstrated a 37% overall response rate in a predominantly third line and later population with a disease control rate of 78%. In combination with standard of care therapies, 734 demonstrated a manageable tolerability profile when combined with both gemcitabine plus nab-paclitaxel and modified FOLFIRINOX without compromising chemotherapy dose intensity.

在計劃的 III 期劑量為每天 200 毫克時，734 作為單藥療法在主要為三線及以後治療的患者群體中顯示出 37% 的總緩解率，疾病控制率為 78%。與標準治療方案合併使用時，734 表現出可控的耐受性，當與吉西他濱加白蛋白紫杉醇和改良的 FOLFIRINOX 聯合使用時，不會影響化療劑量強度。

Taken together, this data support the potential for 734 to be meaningfully integrated into frontline treatment for patients with PDAC. Earlier this year, we gained alignment with the FDA on the registrational program and are on track to initiate our Phase III trial in first-line PDAC in the first-quarter of 2026. If approved, 734 would represent the first G12D targeted therapy for the treatment of patients with pancreatic cancer.

綜合來看，這些數據支持將 734 有意義地整合到 PDAC 患者的第一線治療中。今年早些時候，我們與 FDA 在註冊計劃上達成一致，並預計在 2026 年第一季啟動針對第一線 PDAC 的 III 期試驗。如果獲得批准，734 將成為首個針對 G12D 標靶治療胰臟癌患者的療法。

With pivotal trials now underway for CDK2, TGF-beta receptor by PD-1 and KRAS G12D, our strategic focus is turning to how we can expand these programs across additional tumor types and clinical settings. Our objective is to broaden the potential impact of these programs and reach more patients over time. We expect to provide updates during 2026.

目前，針對 CDK2、PD-1 的 TGF-β 受體和 KRAS G12D 的關鍵性試驗正在進行中，我們的策略重點正在轉向如何將這些項目擴展到其他腫瘤類型和臨床環境。我們的目標是擴大這些項目的潛在影響範圍，並隨著時間的推移惠及更多患者。我們預計將在 2026 年期間提供更新資訊。

Finally, in IAI, we have a JAK anchor franchise with topical to oral solutions across mild to severe immune-mediated dermatological conditions. First, an update with Opzelura. In early 2025, we shared results from the Phase III program in prurigo nodularis, where Opzelura met its primary endpoint, demonstrating statistically significant improvement in itch compared to placebo in one of two registrational studies.

最後，在 IAI 領域，我們擁有 JAK 核心產品系列，涵蓋從輕度到重度免疫介導性皮膚病的局部用藥和口服解決方案。首先是 Opzelura 的更新。2025 年初，我們分享了結節性癢疹 III 期計畫的結果，其中 Opzelura 達到了主要終點，在兩項註冊研究中的一項中，與安慰劑相比，搔癢症狀得到了統計學上的顯著改善。

In January, we received FDA feedback indicating that an additional clinical efficacy study will be required to support registration for this indication. As a result, we have decided to pause further development of Opzelura in PN at this time.

1月份，我們收到FDA的回饋，顯示需要進行額外的臨床療效研究才能支持此適應症的註冊。因此，我們決定暫時停止在PN中對Opzelura的進一步開發。

Opzelura is also being evaluated in a large Phase III registrational program as a topical treatment for mild to moderate hidradenitis suppurativa with results expected from the TRuE-HS1 and TRuE-HS2 trials later this year. Hidradenitis suppurativa is also the most advanced indication for povorcitinib, our novel JAK1 small molecule inhibitor.

Opzelura 目前正在一項大型 III 期註冊項目中進行評估，作為治療輕度至中度化膿性汗腺炎的局部用藥，預計今年晚些時候將公佈 TRuE-HS1 和 TRuE-HS2 試驗的結果。化膿性汗腺炎也是我們新型 JAK1 小分子抑制劑 povorcitinib 最成熟的適應症。

Earlier this year, we presented 24-week Phase III data that further reinforced the differentiated clinical profile of povorcitinib, demonstrating deep and sustained improvements across multiple key endpoints. Importantly, povorcitinib also showed a rapid and robust reduction in skin pain and draining tunnels, a defining symptom for patients and a critical treatment goal for clinicians.

今年早些時候，我們公佈了 24 週的 III 期數據，進一步強化了 povorcitinib 的差異化臨床特徵，證明其在多個關鍵終點方面均有深刻且持續的改善。重要的是，povorcitinib 也顯示出能快速、顯著地減輕皮膚疼痛和引流隧道，這是患者的典型症狀，也是臨床醫生的重要治療目標。

From a regulatory standpoint, we submitted the MAA to the EMA during the fourth-quarter of 2025 and anticipate acceptance of the NDA filing by the FDA in the first-quarter of 2026. Beyond HS, our Phase III registrational trials in vitiligo and PN continue to progress well. In vitiligo, we anticipate data from our two registrational Phase III trials, STOP-V1 and STOP-V2 in mid-2026.

從監管角度來看，我們已於 2025 年第四季向 EMA 提交了 MAA，並預計 FDA 將於 2026 年第一季接受 NDA 申請。除了 HS 之外，我們在白斑症和 PN 方面的 III 期註冊試驗也繼續取得良好進展。在白斑症方面，我們預計 2026 年年中獲得兩項註冊性 III 期試驗 STOP-V1 和 STOP-V2 的數據。

In PN, we anticipate data from our STOP-PN1 and STOP-PN2 studies expected by year-end. Finally, we continue to explore its broader potential with Phase II proof-of-concept data in asthma anticipated in the second half of 2026.

在 PN 領域，我們預期 STOP-PN1 和 STOP-PN2 研究的數據將在年底前公佈。最後，我們將繼續探索其更廣泛的潛力，預計將於 2026 年下半年獲得氣喘 II 期概念驗證數據。

Overall, 2026 is a pivotal year for Opzelura and povorcitinib with important key regulatory and clinical milestones across all evaluated indications. 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. We look forward to an exciting year of execution and to providing continued visibility as these milestones unfold.

總體而言，2026 年對於 Opzelura 和 povorcitinib 來說是至關重要的一年，在所有評估的適應症中都將迎來重要的監管和臨床里程碑。最後，我們即將迎來充滿催化劑的一年，三大核心產品線將陸續公佈多個後期數據、達到監管里程碑並啟動關鍵性試驗，凸顯了我們產品線的廣度、深度和成熟度。我們期待在充滿挑戰的一年中取得突破性進展，並隨著這些里程碑的逐步實現，持續為大家提供相關資訊。

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

接下來，我將把電話交給湯姆，讓他報告本季的財務狀況。

Thanks, Pablo. As Bill mentioned earlier, our total revenues and product revenues for the quarter were $1.51 billion and $1.22 billion, respectively, increasing 28% and 20% from the prior year. For the full year, our total revenues and product revenues were $5.14 billion and $4.35 billion, respectively, increasing 21% and 20% from the prior year.

謝謝你，帕布羅。正如比爾先前所提到的，本季我們的總營收和產品收入分別為 15.1 億美元和 12.2 億美元，比去年同期成長了 28% 和 20%。全年總收入和產品收入分別為 51.4 億美元和 43.5 億美元，比上年分別成長 21% 和 20%。

Our GAAP R&D expenses were $611 million for the quarter, increasing 31% from the prior year. Our GAAP R&D expenses were $2.05 billion for the year. Ongoing R&D expenses increased 8% year-over-year, driven by continued investment in our late-stage development assets.

本季我們的 GAAP 研發費用為 6.11 億美元，比去年同期成長 31%。本年度以美國通用會計準則計算的研發費用為20.5億美元。持續研發支出年增 8%，主要得益於我們對後期開發資產的持續投資。

Moving to SG&A. GAAP SG&A expenses were $390 million for the quarter, increasing 19% year-over-year. Our GAAP SG&A expenses were $1.38 billion for the year, increasing 11% year-over-year, primarily driven by costs associated with the US oncology product launches in 2025 and timing of certain other expenses. Ongoing operating expenses for the full year 2025 increased 11% 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.

移至銷售、一般及行政管理部門。本季 GAAP SG&A 費用為 3.9 億美元，較去年同期成長 19%。本年度 GAAP SG&A 費用為 13.8 億美元，年增 11%，主要原因是與 2025 年美國腫瘤產品上市相關的成本以及某些其他費用的發生時間。2025 年全年持續營運支出較去年同期成長 11%，而同期持續營收年增 19%，導致營運槓桿和利潤率持續上升。

I'll now turn the call back over to Bill.

現在我將把電話轉回給比爾。

Thanks, Tom. Before we close, I want to reiterate our revenue guidance and address our expense outlook for 2026. As mentioned earlier, we have set full year '26 revenue guidance of $4.77 billion to $4.94 billion, representing a 10% to 13% increase from prior year. This includes net revenue expectations for Jakafi of $3.22 billion to $3.27 billion, Opzelura of $750 million to $790 million and hematology/oncology of $800 million to $880 million.

謝謝你，湯姆。在結束之前，我想重申我們的收入預期，並談談我們對 2026 年支出的展望。如前所述，我們已將 2026 年全年營收預期設定為 47.7 億美元至 49.4 億美元，比上年增長 10% 至 13%。其中包括 Jakafi 的淨收入預期為 32.2 億美元至 32.7 億美元，Opzelura 的淨收入預期為 7.5 億美元至 7.9 億美元，血液腫瘤科的淨收入預期為 8 億美元至 8.8 億美元。

Sales for our core business ex-Jakafi will range between $1.57 billion and $1.69 billion, representing roughly a 30% growth rate at the midpoint in 2026. As it relates to expenses, I think we've achieved the right balance between maintaining financial discipline and ensuring we are not underfunding strategic initiatives or compromising our growth prospects.

剔除 Jakafi 後，我們核心業務的銷售額將在 15.7 億美元至 16.9 億美元之間，到 2026 年中期，成長率約為 30%。就支出而言，我認為我們已經在保持財務紀律和確保我們不會對策略性舉措投入不足或損害我們的成長前景之間取得了適當的平衡。

We will continue to get leverage out of this business where we can so that we can create financial breathing room to invest where it matters most. Ultimately, what we're solving for is the steepest possible growth curve post '29 and durable earnings and cash flow. We expect total GAAP R&D and SG&A operating expenses to be $3.495 billion to $3.675 billion in '26. At the midpoint, this represents a 4% increase versus prior year, driven primarily by targeted investments in our late-stage pipeline and launch readiness while maintaining tight control elsewhere.

我們將繼續盡可能地從這項業務中獲取槓桿，以便創造財務喘息空間，從而投資於最重要的領域。歸根究底，我們追求的是2029年後盡可能陡峭的成長曲線以及可持續的收益和現金流。我們預計 2026 年 GAAP 研發和 SG&A 營運總費用為 34.95 億美元至 36.75 億美元。中期數據顯示，與前一年相比成長了 4%，這主要得益於我們對後期研發管線和上市準備工作的有針對性投資，同時在其他方面保持了嚴格的控制。

We expect R&D to be up roughly 10% from last year, consistent with advancing programs that we believe can meaningfully shape the company's future. 80% of our investment in R&D is concentrated in the seven programs Pablo reviewed earlier. As it relates to SG&A, G&A will be down 10% compared to last year, while sales and marketing is modestly higher to support the key launches in the second half of the year. Together, SG&A will remain relatively flat year-over-year, reflecting deliberate reallocation rather than broad-based spending.

我們預期研發投入將比去年成長約10%，這與我們推動那些我們認為能夠對公司未來產生重大影響的項目一致。我們80%的研發投入集中在Pablo之前提到的七個項目。就銷售、一般及行政費用而言，與去年相比，一般及行政費用將下降 10%，而銷售和行銷費用將略有增加，以支持下半年的關鍵產品上市。整體而言，銷售、一般及行政費用將與上年基本持平，反映的是有意的重新分配，而不是廣泛的支出。

Finally, we anticipate cost of goods to remain relatively stable in the 8% to 9% range of net sales. We have an excellent set of opportunities in front of us and a path to replace Jakafi. What matters most right now, like at any company is execution, getting things done, which means orchestrating product launches, running multiple Phase III trials to tight time lines and managing the business at a detailed level.

最後，我們預期商品成本將保持相對穩定，佔淨銷售額的 8% 至 9%。我們面前有很多絕佳的機會，也有了取代雅卡菲的途徑。就像任何公司一樣，現在最重要的是執行力，把事情做好，這意味著要精心策劃產品發布，在緊迫的時間內開展多項 III 期試驗，並在細節層面管理業務。

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

接下來，我將把電話轉交給接線生進行問答環節。

(Operator Instructions)

（操作說明）

Marc Frahm, TD Cowen.

馬克·弗拉姆，TD Cowen。

Congrats on the progress. Maybe to start with Pablo for the CALR pivotal programs, just your latest thoughts as you've gotten into designing the Phase IIIs as to just kind of how to address the potential differences for 989 and dosing for some of the different CALR mutations to ensure full potency.

恭喜你取得進展。或許可以先從 Pablo 開始，談談 CALR 的關鍵項目，您在設計 III 期臨床試驗時，對於如何解決 989 的潛在差異以及針對不同 CALR 突變的劑量問題，能否分享一下您最近的想法，以確保藥物的完全效力。

Its best approach to start low, titrate up for those that need it or maybe prospectively kind of wrap people to different starting doses? Or is it just simplify things and max out dose for everyone. And then maybe just a quick clarifying thing on the commentary around Opzelura pricing.

最好的方法是從小劑量開始，根據需要逐漸增加劑量，或是可以預先設定不同的起始劑量，讓患者逐步適應？或者，這只是簡化流程，讓每個人都服用最大劑量。然後，或許可以簡單澄清一下關於 Opzelura 定價的評論。

Just how much of that was driven by the entry into -- your entry into new markets and needing to access those versus maybe some of the competitive launches putting pressure on the existing indications?

其中有多少是由於進入新市場以及需要進入這些市場所驅動的，又有多少是由於一些競爭對手的產品上市對現有適應症造成的壓力所驅動的？

Go ahead. Pablo will take the first one. Thanks for the questions, Marc.

前進。巴勃羅將拿下第一個。謝謝你的提問，馬克。

Okay. So we're going to discuss this with FDA this quarter. So I just -- I'm going to try not to get too far ahead of ourselves. What we're proposing in principle for the ET second-line study, which we intend to initiate this half in the first half of 2026 is, first of all, the enrolment would be in all patients, patients with all types of mutations, both type 1 and non-type 1 mutations. And we're going to discuss with FDA a dosing strategy, which we think will address the differential potency of 989 across the range of mutations that you brought up in your question.

好的。所以我們將在本季與FDA討論此事。所以我就——我盡量不要操之過急。我們原則上提議，在 2026 年上半年啟動的 ET 二線研究，首先，所有患者，所有類型的突變患者，包括 1 型突變和非 1 型突變患者，都將入組。我們將與 FDA 討論一種給藥策略，我們認為這將解決您在問題中提到的 989 對各種突變的效力差異問題。

We're confident that we have a good strategy. We're also going to discuss the primary endpoint of the study, which obviously will be some version of hematologic response, but the question there is the timing for the evaluation of the primary endpoint, which we would like to discuss with the agency. So all in all, I think we're in a good position. I think we submitted a good package. We look forward to interacting with the agency, and we'll provide an update later this year.

我們相信我們擁有一個好的策略。我們也要討論這項研究的主要終點，顯然會是某種形式的血液學反應，但問題在於評估主要終點的時間安排，我們希望與監管機構討論這個問題。總而言之，我認為我們處境不錯。我認為我們提交的材料很不錯。我們期待與該機構進行互動，並將在今年稍後提供最新進展。

Okay. Thanks, Pablo. And Marc, as it relates to Opzelura, not a competitive issue. We take a very long-term view of Opzelura. We have exclusivity to the end of the next decade. We just launched a pediatric indication. We potentially could have an HS indication.

好的。謝謝你，帕布羅。至於 Marc，就 Opzelura 而言，這不是競爭問題。我們對奧普澤魯拉採取非常長遠的眼光。我們擁有獨家經銷權，直到下一個十年結束。我們剛剛推出了一項兒科適應症。我們可能找到了HS的適應症。

The market is really moving, as you know, as I mentioned, prescribing migrates from steroidal topicals to nonsteroidal topicals. This was about improving formulary coverage for the long term at the major PBMs so that it's a frictionless experience for dermatologists and patients. And I would expect the impact on ASP in '26 to roll off in 2027 and beyond, we'll be providing fewer discounts in the future than we did in the past. That's it.

如你所知，正如我之前提到的，市場正在發生巨大的變化，處方藥的使用正在從類固醇類外用藥轉向非類固醇類外用藥。這是為了從長遠角度改善主要藥品福利管理機構的處方集覆蓋範圍，從而為皮膚科醫生和患者提供順暢的體驗。我預計 2026 年對 ASP 的影響將在 2027 年及以後逐漸消失，未來我們將提供的折扣會比過去少。就是這樣。

Tazeen Ahmad, Bank of America.

塔津·艾哈邁德，美國銀行。

Also one on Opzelura. So can you just give us your sense of what the uptake is in the current approved indications and the average number of tubes that are being used? We understand the importance of being on formulary, but we'd also like to get a better sense of how to better model sales on a go-forward basis.

還有一篇關於奧普澤魯拉的文章。那麼，您能否簡要介紹一下目前已批准適應症的接受程度以及平均使用的導管數量？我們理解進入藥品目錄的重要性，但我們也希望更了解如何更好地建立未來銷售模型。

Yes, I can break this down a little, Tazeen. First, the AD business is growing at almost 20% year-over-year. You saw that in our '25 results. And then you have a vitiligo business that's growing in the mid-teens. And roughly 60% of our business is AD and roughly 40% of it is vitiligo.

是的，我可以稍微解釋一下，塔津。首先，廣告業務的年增長率接近 20%。你從我們2025年的成績中已經看到了這一點。然後，白斑症治療產業的發展速度達到了十幾個百分點。我們大約 60% 的業務是 AD，大約 40% 的業務是白斑症。

I would also comment that we launched for pediatrics in 2025. And that business, when you look at prescription data on a weekly basis is already annualizing at $30 million. So when you're thinking about modeling Opzelura, that business is going to grow over the next five years at about a 10% CAGR. That's how I would think about net sales. The other piece of Opzelura that you have to think about is the international business.

我還要補充一點，我們計劃在 2025 年推出兒科產品。如果按週查看處方數據，該業務的年收入已達到 3,000 萬美元。因此，在考慮對 Opzelura 進行建模時，預計該業務在未來五年內將以約 10% 的複合年增長率成長。這就是我對淨銷售額的看法。奧普澤魯拉的另一個需要考慮的方面是國際業務。

Now internationally, we finished '25 with $130 million in sales in vitiligo. We're launching for moderate AD in that same market in the second half of the year. Most of the benefit will be in '27. The AD market is five times the size of the vitiligo market. So I estimate there's probably $300 million in incremental revenue for Opzelura internationally over the next five years.

現在，在國際市場上，我們在 2025 年白斑領域的銷售額達到了 1.3 億美元。我們將在今年下半年在該市場推出針對中等廣告需求的產品。大部分收益將在 2027 年顯現。AD市場規模是白斑市場的五倍。因此，我估計 Opzelura 在未來五年內，國際市場可能會新增 3 億美元的收入。

So we're going to -- we finished the year at roughly $700 million, give or take, just below. $300 million of that could come from the United States, driven by AD, vitiligo, and then $300 million internationally just by the -- just with the launch in moderate AD. What I haven't factored into this is if we get an indication for HS, for Opzelura at the end of 2027.

所以，我們今年的銷售額大概在7億美元左右，上下浮一點。其中3億美元可能來自美國，主要由AD和白斑症的治療推動；另外3億美元來自國際市場，僅中度AD的上市就能帶來這3億美元的收入。我還沒算進去的是，如果Opzelura在2027年底獲得化膿性汗腺炎（HS）的適應症，那將會是怎樣的益處。

Most of our growth will be volume. We expect some modest price actions over the next several years. I think most of the heavy lifting as it relates to securing formulary coverage and the investment in that is behind us. And that's how you think about this business. Essentially, you're going to grow at a CAGR of, call it, 10% to 15%. Thanks for the question.

我們的大部分成長將來自銷量。我們預期未來幾年價格波動幅度不大。我認為，在確保藥品納入健保範圍和相關投資方面，大部分艱苦的工作已經完成了。這就是你對這個行業的看法。基本上，你的複合年增長率將達到 10% 到 15%。謝謝你的提問。

Michael Schmidt, Guggenheim Securities.

邁克爾·施密特，古根漢證券。

This is Rosy on for Michael. Just some questions on frontline. I guess with Monjuvi succeeding in frontline DLBCL, Bill, you had mentioned that 50% of patients are receiving R-CHOP.

這是羅西為邁克爾主持節目。一些關於前線的問題。Bill，我想Monjuvi在DLBCL一線治療中取得成功後，你曾提到50%的患者正在接受R-CHOP治療。

But just can you help us understand how you're thinking about the overall opportunity for Monjuvi in the setting and just positioning versus POLIVY? And then a quick follow-up. I guess on the trial, with the IPI eligibility criteria, it seems like the trial would maybe have a higher enrichment of patients with a poor prognosis.

您能否幫助我們了解您是如何看待 Monjuvi 在當前市場環境和定位方面與 POLIVY 相比的整體機會的？然後是一個簡短的後續問題。我猜想，根據 IPI 入選標準，該試驗中預後不良的患者比例可能會更高。

So I guess in this context, how should we think about the PFS benefit that you reported? And are there any implications here for Monjuvi's potential use across a broader frontline population?

所以我想在這個背景下，我們應該如何看待您報告的 PFS 獲益呢？那麼，這對於Monjuvi在更廣泛的一線人群中的潛在應用有何影響呢？

Great questions. I'll have Pablo answer the second question, and then we'll double back and answer the first question. Thanks, Pablo.

問得好。我會先讓巴勃羅回答第二個問題，然後再回頭回答第一個問題。謝謝你，帕布羅。

So you're correct. The study was focused on patients with IPI 3 to 5, and that is a group with the worse prognosis than what has been reported by some of our competitors in the frontline DLBCL setting. I also would encourage you, what we know today, obviously, as mentioned in the script, that about half the patients are still getting R-CHOP. And the recently introduced competitors in this space do not address the need of all patients with DLBCL.

你說得對。該研究重點關注 IPI 3 至 5 的患者，與一些競爭對手在 DLBCL 一線治療中報告的預後相比，該組患者的預後較差。我還要鼓勵你們，正如劇本中提到的，我們今天顯然知道，大約一半的患者仍然接受 R-CHOP 治療。而最近進入這一領域的競爭對手並不能滿足所有瀰漫性大B細胞淋巴瘤患者的需求。

As you know, there's an entire subset of patients here with GCB DLBCL that are not currently addressed by one of the more recent entries in the space. We look forward to showing the full benefit of Monjuvi in this patient population. We think that the benefit in PFS that we reported is very competitive. As you know, the safety profile of Monjuvi is very well established in this context. So we'll discuss the results in more detail over the course of the year, but we're very encouraged by what we're seeing across the entire spectrum of patients with DLBCL with IPI 3 to 5.

如您所知，這裡有一部分患有 GCB DLBCL 的患者，目前該領域較新的療法尚未能滿足他們的需求。我們期待向該患者群體展示 Monjuvi 的全部益處。我們認為，我們所報告的 PFS 獲益非常有競爭力。如您所知，Monjuvi 在此方面的安全性已得到充分證實。因此，我們將在今年內更詳細地討論結果，但我們對 IPI 3 至 5 的 DLBCL 患者的整體情況感到非常鼓舞。

Yes. I'll just make a couple of comments, and then I'll ask Mohamed, who runs Monjuvi to finish up. Right now, we're going to have by the end of '26, early '27 a three-indication product. And we'll finish this year somewhere in the range of the mid-$200 million. With an indication of frontline DLBCL, and I don't see it as a fight to the death between POLIVY and Monjuvi, we have a very positive study in frontline DLBCL, clear separation in terms of PFS. It's simply an intensification strategy with Monjuvi being added to Len and R-CHOP versus a substitution or a replacement strategy with POLIVY.

是的。我簡單提幾句，然後請Monjuvi的負責人Mohamed來總結。目前來看，我們將在 2026 年底或 2027 年初推出一款具有三種適應症的產品。我們今年的最終業績應該會在2億美元中段左右。對於一線 DLBCL 治療，我認為 POLIVY 和 Monjuvi 之間並非生死之戰，我們在一線 DLBCL 治療方面有一項非常積極的研究，在 PFS 方面有明顯的差異。這只是在 Len 和 R-CHOP 的基礎上增加了 Monjuvi 的強化治療策略，而不是用 POLIVY 進行替代或替換的策略。

And so there's incremental revenue associated with Monjuvi that will support building this core business in 2030 to $3 billion to $4 billion. Mohamed, do you have anything to add?

因此，Monjuvi 帶來的增量收入將支持公司在 2030 年將核心業務規模擴大到 30 億至 40 億美元。穆罕默德，你還有什麼要補充的嗎？

Yes. Thanks, Rosy, for the question. First-line DLBCL represents the largest potential opportunity for Monjuvi with approximately 30,000 patients treated annually. And 50% of those patients, as was mentioned, are still being treated with R-CHOP today.

是的。謝謝Rosy的提問。一線瀰漫性大B細胞淋巴瘤是Monjuvi最大的潛在市場，每年約有30,000名患者接受治療。如同前面所提到的，其中 50% 的患者至今仍在接受 R-CHOP 治療。

And as Bill just described, Monjuvi is an addition to R-CHOP versus replacing R-CHOP. And as Pablo mentioned, full spectrum of efficacy across all different types of patients with the PFS benefit that's been communicated, I think, positions Monjuvi, not just for short-term growth, but continues to make Monjuvi a meaningful contributor, as you heard from Bill and others, around our growth story in 2029 and beyond. Thanks for the question, Rosy.

正如比爾剛才所描述的，Monjuvi 是 R-CHOP 的補充，而不是取代 R-CHOP。正如 Pablo 所提到的，Monjuvi 對所有不同類型的患者都具有全面的療效，並且已經傳達了 PFS 獲益，我認為這不僅使 Monjuvi 能夠實現短期增長，而且正如你從 Bill 和其他人那裡聽到的那樣，Monjuvi 將繼續為我們 2029 年及以後的增長故事做出有意義的貢獻。謝謝你的提問，羅西。

Eric Schmidt, Cantor Fitzgerald.

艾瑞克·施密特，坎托·費茲傑拉。

Maybe I'll ask about 890, your bispecific for colorectal cancer. Are we going to see any additional Phase I/II data in 2026? And does the pivotal study have an interim analysis?

也許我會問關於 890 的事，那是你們的結直腸癌雙特異性抗體。2026年我們會看到更多I/II期臨床試驗數據嗎？這項關鍵性研究是否有中期分析？

Thanks, Eric. Pablo, Steven, do you want to take that?

謝謝你，埃里克。巴勃羅，史蒂文，你們想拿嗎？

Yes, Eric. So yes, you will see additional data over the course of the year. That program, as I mentioned in my prepared remarks, was initiated -- the Phase III study was initiated already. We're in the process of expanding the footprint. We have identified more than 200 sites globally to execute the study, and we look forward to sharing updated data both in combination with FOLFOX bevacizumab as well as other combinations that we are implementing for that program. So you'll see more data over the course of the year. We'll give more clarity on the specific timing of those as the year progresses depending on submissions to different conferences.

是的，埃里克。是的，在這一年中您會看到更多數據。正如我在準備好的演講稿中提到的，該計劃已經啟動——第三階段研究已經啟動。我們正在擴大業務範圍。我們已在全球範圍內確定了 200 多個研究地點，我們期待分享 FOLFOX 聯合貝伐單抗以及我們正在為該計畫實施的其他聯合療法的最新數據。所以，在這一年中，你會看到更多的數據。隨著今年的推進，我們將根據向不同會議提交的論文數量，進一步明確具體時間表。

Salim Syed, Mizuho.

Salim Syed，瑞穗銀行。

This is Erik Lavington on for Salim. So just wondering if we could get a little bit more color on the Opzelura in PN and why the FDA was asking for another Phase III or recommending it, if that has any read-through to the Opzelura in HS or if -- per chance might have to do with trial designs for HS, PN?

這是埃里克·拉文頓替薩利姆上場。所以，我想知道能否更詳細地了解一下 Opzelura 在 PN 中的應用，以及 FDA 為什麼要求或建議進行另一項 III 期臨床試驗，這是否對 Opzelura 在 HS 中的應用有任何參考意義，或者——或許——這可能與 HS 和 PN 的試驗設計有關？

Great. Thanks for the question. Steven Stein will answer that for you.

偉大的。謝謝你的提問。史蒂文·斯坦會為你解答這個問題。

Eric, thank you. You asked a few questions related to both PN and HS. So just in Pablo's prepared remarks, if you remember, we conducted two large Phase IIIs in prurigo nodularis. The one study was positive and statistically significant. The second study just missed.

艾瑞克，謝謝你。你問了一些與PN和HS都相關的問題。所以，正如巴勃羅事先準備好的發言稿中所述，如果你還記得的話，我們針對結節性癢疹進行了兩項大型 III 期臨床試驗。其中一項研究結果為陽性，且具有統計意義。第二項研究結果略有偏差。

Based on comments during the year that the FDA made, we approached them if the combined analysis could suffice to get across the finish line because we had conducted two studies and one was negative, they strongly recommended that an additional trial, a third study would be needed in this setting and would obviously have to be positive to get it across the finish line. So it's a unique situation where we had two studies, one positive, one negative. And as Pablo said, that's why the program is currently paused while we debate whether or not to conduct an additional study.

根據 FDA 在過去一年中提出的意見，我們向他們詢問，如果進行兩項研究，其中一項結果為陰性，那麼綜合分析是否足以完成研究。他們強烈建議進行額外的試驗，在這種情況下需要進行第三項研究，而且顯然必須取得陽性結果才能完成研究。所以這是一個特殊的情況，我們有兩個研究，一個結果是陽性，一個結果是陰性。正如巴勃羅所說，這就是為什麼該項目目前暫停，我們正在討論是否進行額外的研究。

There is no read-through to HS. In our HS studies, we're doing standard regulatory development. Again, two large Phase IIIs accruing very well. As you know, our proof-of-concept data is very strong there. And obviously, we want those studies to be positive and get across the finish line. And I don't know if Pablo wants to add anything else.

沒有與高中銜接的讀法。在我們的HS研究中，我們正在進行標準的監管開發。再次強調，兩項大型 III 期臨床試驗進展非常順利。如您所知，我們在那裡的概念驗證數據非常強大。顯然，我們希望這些研究結果都是正面的，並且能夠順利完成。我不知道巴勃羅是否還有什麼要補充的。

No, I will just add just a small comment on PN. While the second study did barely miss the primary endpoint of itch, it was very positive for the investigator global assessment of treatment success. So we're convinced that Opzelura has strong efficacy in patients with prurigo nodularis. As I mentioned in my prepared remarks, we paused further development there. We're discussing whether we do -- we will or will not do an additional trial to try to support that indication. I obviously agree with Steven. I don't think there's any read-through to the HS indication.

不，我只想在PN上補充一點評論。雖然第二項研究在搔癢這一主要終點方面略有偏差，但對於研究者而言，其對治療成功的整體評估結果非常積極。因此我們確信，Opzelura 對結節性癢疹患者俱有很強的療效。正如我在準備好的演講稿中提到的，我們暫停了那裡的進一步開發。我們正在討論是否要進行額外的試驗來驗證這個結論。我當然同意史蒂文的觀點。我不認為HS指標有任何參考意義。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Could you speak to the mCALR bispecific here? You've guided to Phase I data next year. Maybe tell us more about this asset and how it could be differentiated from your current mCALR program? And then on 617F, where we'll see initial Phase I data in the second half, what is your current level of conviction for this asset? And walk us through the profile you want to see here to make that go/no-go decision?

您能談談這裡的 mCALR 雙特異性嗎？您已指導明年獲得第一階段數據。能否詳細介紹一下這項資產，以及它與您目前的 mCALR 程序有何不同？然後，關於 617F，我們將在下半年看到第一階段的初步數據，您目前對這項資產的信心程度如何？請您詳細介紹一下您希望在這裡看到哪些資料，以便我們做出是否繼續的決定？

Thanks, Salveen. Pablo will take that.

謝謝你，薩爾文。巴勃羅會接受的。

Thanks, Salveen. So let me take first the CALRxCD3 bispecific program. So that study is really now accelerating. So we're very encouraged that the enrollment is going well. As you might remember, we designed our CALRxCD3 T-cell engager bispecific purposefully with the CALR arm binding to a different epitope from our CALR antibody.

謝謝你，薩爾文。首先，讓我來看看 CALRxCD3 雙特異性程式。所以這項研究現在確實正在加速推進。招生工作進展順利，我們感到非常鼓舞。您可能還記得，我們​​特意設計了 CALRxCD3 T 細胞銜接器雙特異性抗體，使 CALR 臂與 CALR 抗體的不同表位結合。

The reason for that is obviously, if patients for some reason do not respond to the CALR antibody, there would be ideal targets for the bispecific. Now in terms of understanding where exactly we'll place the bispecific in the treatment paradigm for patients with MPNs, I think it's too soon for me to elaborate too much there. We believe that there might be some patients that require more potent approach or that require a molecule that produces faster responses or perhaps that after initial responses to the CALR antibody for some reason, progress.

原因很明顯，如果患者因為某些原因對 CALR 抗體沒有反應，那麼雙特異性抗體就有了理想的標靶。至於我們究竟要如何理解雙特異性抗體在 MPN 患者的治療方案中的位置，我認為現在詳細闡述還為時過早。我們認為，有些患者可能需要更強效的治療方法，或需要一種能產生更快反應的分子，或者由於某種原因，在對 CALR 抗體產生初步反應後，病情會有所進展。

As we generate the efficacy data that we will have next year for the bispecific, we will get more clarity on what's the position in the treatment paradigm in patients with MPNs. As you know, and I reiterated at ASH last year, our goal by the end of the decade is to have a treatment solution for every single patient with MPN. That's why we think the bispecific could play a role.

隨著我們明年獲得雙特異性抗體的療效數據，我們將更清楚地了解該抗體在 MPN 患者治療方案中的地位。如您所知，我去年在 ASH 大會上也重申過，我們的目標是在本十年末為每位 MPN 患者找到治療方案。這就是為什麼我們認為雙特異性抗體可能發揮作用的原因。

Now in terms of the V617F program, we remain fully convinced that if you hit this driver mutation, the V617F mutation patients in PN, if we hit it hard enough, we will get the same type of outcomes that we saw with the CALR antibody in MF and ET. This is a driver mutation. We have a small molecule inhibitor.

就 V617F 計劃而言，我們仍然完全相信，如果我們能夠有效治療 PN 中的 V617F 突變患者，我們將獲得與 CALR 抗體在 MF 和 ET 中相同的治療效果。這是驅動突變。我們有一種小分子抑制劑。

We have very strong preclinical package that we presented repeatedly. And we believe that if we hit it hard enough, we will get the same kind of transformative clinical effects and molecular effects that we saw with 989. We just need to generate that data. We are now entering the clinic with a new formulation that we discussed recently, a solid dispersion formulation. We will have data later this year. And once we have that data, we'll tell you what the next steps of the program are.

我們擁有非常強大的臨床前研究方案，並且已經多次展示。我們相信，如果我們用力過猛，就能獲得與 989 一樣具有變革性的臨床效果和分子效果。我們只需要產生這些數據。我們現在正帶著最近討論過的新配方——固體分散體配方——進入臨床試驗。我們將在今年稍後獲得數據。一旦我們獲得這些數據，我們將告訴您該計劃的下一步是什麼。

And Pablo, also the key is that with 617F, we'll cover three MPNs, MF, ET, and PV, not just MF and ET. And the mutation frequency, as you know, Salveen, is two times, three times what it is for CALR. And so you'd essentially with 617 cover 80% of MF and ET and PV.

帕布羅，關鍵在於，有了 617F，我們將涵蓋三個 MPN，MF、ET 和 PV，而不僅僅是 MF 和 ET。薩爾文，你也知道，這個突變頻率是 CALR 的兩到三倍。因此，617 基本上可以涵蓋 80% 的 MF、ET 和 PV。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

As you plan your KRASG12D study, can you share your thoughts on the trial design? And how are you viewing the competitive landscape that's evolving in PDAC and potential advantages for your program? And do you plan to run any additional Phase III studies beyond PDAC?

當您規劃 KRASG12D 研究時，能否分享一下您對試驗設計的想法？您如何看待 PDAC 領域不斷變化的競爭格局以及您的專案可能獲得的潛在優勢？除了 PDAC 之外，您是否計劃進行任何其他 III 期研究？

I'm going to have Steven comment on the trial design, then I can come back with the competitive landscape and the expansion of this program. Go ahead.

我打算請 Steven 對試驗設計提出意見，然後我再來談談競爭格局和該專案的擴展。前進。

Yes, Jay, thank you for the question. So as Pablo said in the updated at ASCO GI, we had that 37% response rate with very encouraging data on duration of response, potentially a read-through from duration of treatment to PFS. So we're really encouraged. I think the second really important point there was the ability to combine our 12D inhibitor with both standard of care chemotherapy regimens in the frontline.

是的，傑伊，謝謝你的提問。正如 Pablo 在 ASCO GI 的更新中所說，我們獲得了 37% 的緩解率，並且緩解持續時間的數據非常令人鼓舞，這可能預示著治療持續時間將影響 PFS。所以我們深受鼓舞。我認為第二個非常重要的點是，我們的 12D 抑制劑能夠與第一線治療的標準化療方案結合。

So gem/Abraxane plus modified FOLFIRINOX and the ability to deliver those regimens with the dose. So you can read through to that. Obviously, the study will go up on clinicaltrials.gov as soon as it's open, that we intend to do a first-line study in combination with both chemotherapy regimens. We'll stratify accordingly. It will probably be 50-50% approximately each use and then it will be a comparison to the chemotherapy with standard time-to-event endpoints.

因此，吉西他濱/紫杉醇加改良的 FOLFIRINOX 方案以及以此劑量實施這些方案的能力。所以你可以一直讀到那裡。顯然，一旦研究開始，就會在 clinicaltrials.gov 上公佈，我們打算進行一線研究，將兩種化療方案合併使用。我們將據此進行分層。每次使用效果可能約為 50-50%，然後與化療進行比較，採用標準的事件發生時間終點。

We may look at things along the way in terms of response rate, et cetera, but it's a time-to-event study in that setting. In terms of other studies beyond PDAC, obviously, this is a compound that we really like. I just alluded to the activity in PDAC. We have interesting activity in other tumor types where 12D is important like colorectal cancer and lung, et cetera. So stay tuned to developments there.

我們可能會從回應率等方面來觀察情況，但就此而言，這是一項時間事件研究。除了 PDAC 之外的其他研究之外，顯然，我們非常喜歡這種化合物。我剛才只是提到了 PDAC 的活動。我們在其他腫瘤類型中也發現了有趣的活動，例如 12D 很重要的大腸直腸癌和肺癌等。請繼續關注事態發展。

And including in PDAC as well, there's potential to potentially do things like adjuvant or neoadjuvant studies as well, which we'll outline as soon as we're ready to do so. So it's an important compound to us. We may well be the first 12D to get across the finish line in terms of mutation-specific therapy in a large tumor with massive unmet need and the ability to combine with both first-line standards of care chemotherapy.

此外，在 PDAC 領域，也有可能開展輔助治療或新輔助治療研究，一旦準備就緒，我們將立即概述這些研究。所以它對我們來說是一種重要的化合物。我們很可能成為第一個在大型腫瘤中實現突變特異性治療並能與第一線標準治療化療相結合的 12D 療法的先驅。

Thanks, Steven. And Jay, just regarding the competitive landscape, and I think this is true not just for 734 or G12D, but also TGF-betaxPD-1. Both these cancers, response rates are low, survival times are short, and there haven't been novel treatments in the frontline setting in decades.

謝謝你，史蒂文。Jay，就競爭格局而言，我認為這不僅適用於 734 或 G12D，也適用於 TGF-betaxPD-1。對於這兩種癌症，治療反應率都很低，存活期很短，而且幾十年來一線治療中都沒有新的療法。

G12D as a target was the Everest of oncology. TGF-beta by PD-1, no one's cracked the code. Now we have to convert Phase I to Phase III. But I don't think this is about competition. These are the largest wide open white spaces in cancer.

G12D 作為腫瘤學標靶，堪稱腫瘤學的珠穆朗瑪峰。PD-1介導的TGF-β調控機制尚未被破解。現在我們需要將第一階段轉換為第三階段。但我認為這與競爭無關。這些是癌症中最大的空白區域。

We could be first or early in pancreatic and we could be first and only in colorectal. And so right now, we have to execute this program and as Pablo talked about and Steven, expand these programs. And we have the capabilities and the resources to maximize both assets. If we ever needed a partner, we would think about that carefully, expand our geographic reach, and we would do it on our term. But we are sort of locked in on both of these. And I think competition is less important. Phase III execution is most important.

我們可能是胰臟癌領域的第一人或早期患者，也可能是大腸直腸癌領域的第一人或唯一患者。所以現在，我們必須執行這個計劃，正如 Pablo 和 Steven 所說，要擴大這些計劃。我們有能力和資源最大限度地利用這兩項優勢。如果我們需要合作夥伴，我們會認真考慮，擴大我們的地理覆蓋範圍，並且我們會按照我們自己的方式去做。但我們在這兩件事上都陷入了僵局。而且我認為競爭沒那麼重要。第三階段的執行最為重要。

Matt Phipps, William Blair.

馬特·菲普斯，威廉·布萊爾。

This is Madeleine on for Matt Phipps. On povo in HS, did the pre-NDA discussions with the FDA discuss the potential to include biologic-naive patients in the labelled indication?

這裡是 Madeleine 為 Matt Phipps 做報道。在 HS 中，與 FDA 的 NDA 前討論是否涉及將未接受過生物製劑治療的患者納入標籤適應症的可能性？

Yes. Thank you for the question. I'll let Steven Stein answer it.

是的。謝謝你的提問。這個問題就讓史蒂文·斯坦來回答吧。

Yes. So obviously, our study included both populations, pre-biologic, and post-biologic. In fact, about 33% to 36% of patients had biologic exposure. You saw the activity, which we updated during the year, showing extremely encouraging HiSCR response rate that increased over time, excellent pain control upwards of 70% of patients over time having little to no pain and excellent data on draining tunnel.

是的。顯然，我們的研究涵蓋了生物學出現之前的人群和生物學出現之後的人群。事實上，約有 33% 至 36% 的患者接觸過生物製劑。您已經看到了我們在這一年中更新的活動，結果顯示 HiSCR 反應率非常令人鼓舞，並且隨著時間的推移而增加，疼痛控制效果極佳，超過 70% 的患者隨著時間的推移幾乎沒有疼痛，並且引流隧道的數據也非常好。

And that includes -- is included in both populations. The post-biologic activity is a little higher. We submitted the NDA, as we alluded to in our remarks, and that will be by the end of this first-quarter should be signed off by the FDA. And we are seeking a label in both populations.

這包括——包含在這兩個群體中。生物活性後略高。正如我們在演講中提到的，我們已經提交了新藥申請，預計到本季末將獲得美國食品藥物管理局 (FDA) 的批准。我們正在為這兩個群體尋找合適的標籤。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

We just wanted to get incremental color on expectations for the 989 readout in frontline MF later this year. What are you guys looking for in order to kind of move forward in that setting?

我們只是想進一步了解今年稍後一線 MF 的 989 讀數的預期情況。你們在這個環境中尋求的是什麼，才能取得進展？

Pablo?

巴勃羅？

So by the second half of this year, we'll have a pretty substantial data set in patients with previously untreated myelofibrosis and that we're randomizing patients to 989 versus the combination of 989 ruxolitinib. So we'll have a very good idea of what the efficacy is in that population. Now let me make something very clear. I believe the data we have today with 989 that we presented at ASH that we have with 989 mostly in previously treated patients with MF, a little bit of naive patients that were not eligible for Jakafi.

因此，到今年下半年，我們將獲得相當可觀的關於以前未接受治療的骨髓纖維化患者的數據集，我們將隨機分組，分別接受 989 治療和 989 魯索替尼聯合治療。這樣我們就能非常清楚地了解該藥物在該族群中的療效。現在我要把話說清楚。我認為我們今天在 ASH 上展示的 989 例數據，主要是在先前接受過治療的 MF 患者中，還有一些不符合 Jakafi 治療條件的初治患者。

I am convinced that the efficacy and safety of 989 will support development in the first-line setting. We do need the data set that we'll present later this year in order to discuss with FDA how to design and implement the Phase III trials, but I am fully convinced that this medicine will be developable in first-line MF, and we'll give you more clarity later this year.

我確信 989 的療效和安全性將支持其在一線治療中的應用。我們需要今年稍後提交的數據集，以便與 FDA 討論如何設計和實施 III 期試驗，但我完全相信這種藥物可以開發為一線 MF 治療藥物，我們將在今年晚些時候向您提供更清晰的信息。

Andy Chen, Wolfe Research.

Andy Chen，Wolfe Research。

This is Brandon on for Andy. Regarding the XR, any preliminary conversations with payers on formulary access or early signs that give you confidence on the eventual launch here?

這是布蘭登替安迪發言。關於XR，您是否已與支付方就藥品目錄准入事宜進行過初步洽談？或者是否有任何早期跡象讓您對最終在此上市充滿信心？

Yes, it's a good question. We absolutely have had conversations with every major PBM. Here's how I would think about it. I think that Jakafi is the perfect product for an XR formulation because if you think about it, it treats a chronic symptomatic disease, a twice-a-day drug with a three-hour half-life.

是的，這是個好問題。我們確實與所有主要的藥品福利管理機構都進行過溝通。我是這樣考慮的。我認為 Jakafi 是 XR 製劑的完美產品，因為仔細想想，它治療的是一種慢性症狀性疾病，需要每天服用兩次，半衰期為三小時。

And we know that once-a-day formulations produce an adherence gain of 15% to 25%. So there is a medical reason why this product should be put on formulary. That's point number one. Point number two is we have to set a price that makes sense for the PBMs and the health plans for the patients and for Incyte. And there is a price point that's going to make sense. We think about it in three contexts.

我們知道，每日一次的配方可使依從性提高 15% 至 25%。因此，從醫學角度來看，該產品應該被納入藥品目錄。這是第一點。第二點是，我們必須制定一個對藥品福利管理機構 (PBM)、患者的健康計劃以及 Incyte 來說都合理的價格。而且總有一個價格點是合理的。我們從三個方面來考慮這個問題。

One is what is the net cost of the plan; two, what is the coinsurance and patient out of pockets and then three, what will be rebates. Now a new product, your goal is to get 80% to 100% coverage. With an extended-release formulation like Jakafi, you're probably not going to reach into that top tier of formulary coverage. But we should get enough formulary coverage to enable a conversion rate of 10% to 30%, pick the midpoint. Most of '26 will be about that. You'll start to see meaningful conversion in 2027. Thanks for the question.

第一，該計劃的淨成本是多少；第二，共同保險和患者自付費用是多少；第三，將有哪些退款。現在推出新產品，目標是達到 80% 到 100% 的覆蓋率。像 Jakafi 這樣的緩釋製劑，你可能無法獲得最高等級的健保報銷。但我們應該獲得足夠的處方集覆蓋率，以實現 10% 到 30% 的轉換率，選擇中間值。2026 年的大部分時間都將圍繞著這件事。2027年你將開始看到顯著的轉換率提升。謝謝你的提問。

Evan Seigerman, BMO

埃文·塞格曼，BMO

When you're thinking about the Phase III HS data for Opzelura in 4Q, talk to me about how you plan to manage the placebo response for this trial and especially with it being tested in kind of the mild to moderate patient population, which you could have a more exaggerated dynamic with the placebo.

當您考慮 Opzelura 在第四季度的 III 期 HS 數據時，請與我談談您計劃如何管理該試驗中的安慰劑反應，尤其是在輕度至中度患者群體中進行測試的情況下，安慰劑的動態可能會更加誇張。

Thanks, Evan. Go ahead, Steven.

謝謝你，埃文。請繼續，史蒂文。

Yes, Evan, thanks for the question. You're right. So when you have a lower burden of abscess and nodules, you can get an inflated placebo response rate. The two ways we're managing that in the Phase IIIs are a larger study, a greater end and setting the minimum number of requirement on abscess and nodules, which should manage an artificial placebo response rate and then also looking at higher rates of HiSCR control like HiSCR755.

是的，埃文，謝謝你的提問。你說得對。因此，當膿瘍和結節的負擔較輕時，安慰劑效應的發生率可能會偏高。我們在 III 期臨床試驗中採取的兩種管理方法是：擴大研究規模，設定更高的終點，並設定膿腫和結節的最低數量要求，這應該可以控制人為的安慰劑反應率，然後還要關注像 HiSCR755 那樣更高的 HiSCR 控制率。

So all of the above, larger study, a minimum number of abscess and nodules and a higher HiSCR control rate and then obviously two studies as well. And that's the main ways we're trying to control the placebo response rate.

因此，以上所有因素，更大的研究，最少的膿腫和結節，更高的 HiSCR 控制率，以及顯然的兩項研究。這就是我們試圖控制安慰劑效應發生率的主要方法。

Derek Archila, Wells Fargo.

Derek Archila，富國銀行。

Just quickly, so how much revenue contribution from RUX XR are you really baking into the Jakafi guide? And I just wanted to clarify, so you highlighted 30% penetration for Jakafi in PV right now. I guess what level do you think you can get to before LOE?

快速問一下，您在 Jakafi 指南中實際計入了 RUX XR 多少收入貢獻？我只是想確認一下，您剛剛提到 Jakafi 目前在 PV 的滲透率為 30%。我想問你，在達到LOE之前，你覺得你能達到什麼程度？

As it relates to the guidance for 2026, there's no incremental revenue associated with XR in that number. And so we expect that Jakafi in '26 between MF, PV and GVHD will grow in the high single digits and there's going to be some modest price actions, and that gets us to the current guidance. When you think about this business over the next three years, the two indications that are growing at a double-digit rate, PV, and GVHD.

就 2026 年的業績指引而言，該數字中沒有與 XR 相關的新增收入。因此，我們預計 2026 年 Jakafi 的 MF、PV 和 GVHD 之間的成長將達到較高的個位數，價格將會出現一些溫和的波動，這就是我們目前的指導意見。展望未來三年，該產業將以兩位數的速度成長，其中兩個指標為 PV 和 GVHD。

And I would look at this as a mid -- maybe mid- to high single-digit grower between now and 2028, the end of '28 when we actually transition and generics are introduced. I think it's the best way to model and think about the business. I think I've been pretty consistent about how to think about Jakafi. And as it relates to conversion, if we can pick up, take the midpoint 20%, you're going to have almost $0.25 billion sitting in XR when we get to the 29 here.

我認為從現在到 2028 年底，也就是我們真正過渡到仿製藥上市的時候，這個行業可能會保持中等至較高的個位數成長。我認為這是建立業務模型和思考業務的最佳方式。我認為我對 Jakafi 的看法一直相當一致。至於轉換率，如果我們能達到中間值 20%，那麼到 29 日，XR 領域將累積近 2.5 億美元的資金。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，加拿大皇家銀行資本市場。

So on 989 now that you have some alignment with the FDA. I was wondering if you could give us a sense of just the potential volumes and injection times that you're going to be testing for the subcu bioequivalence study? And maybe talk about the most probable path for integrating the subcu into the broader program and potential timelines there.

既然你們現在與 FDA 達成了一些共識，那麼關於 989 號法案，就先這樣吧。我想請您簡要介紹一下您將在皮下生物等效性研究中測試的潛在註射量和注射時間？或許還可以討論一下將潛艇整合到更廣泛的計劃中的最可能途徑以及可能的時間表。

So let me make a couple of comments on the subcu development. And it's a little bit early for me to answer your question with a lot of precision. So let me try this. The study will test -- the first thing we need to answer is what's the bioavailability of the formulation that we're going to test subcu. We obviously have preclinical data, but now we need human data to really understand exactly what that is. So that's point number one.

那麼，我想就子晶片的開發發表幾點看法。現在要我精確回答你的問題還為時過早。那我試試看。這項研究將測試—我們需要回答的第一個問題是，我們將要進行皮下注射測試的製劑的生物利用度是多少。我們顯然有臨床前數據，但現在我們需要人體數據才能真正了解它究竟是什麼。這是第一點。

The second -- and as I mentioned, related to the first Phase III trial in second-line ET is we need to align with FDA, which we'll do this quarter on the dosing strategy for patients with ET. Once we have those two pieces of data, bioavailability of the subcu formulation and dosing strategy, I will be able to answer your question about volume and infusion time. As you remember, we signed a collaboration with Enable late last year, I believe in October of last year to use the enFuse device, which will allow very high volumes of infusions by the patients at home without the need to go to the doctor's office. It's a self-applied device.

第二點——正如我所提到的，與二線 ET 的第一個 III 期試驗有關——我們需要與 FDA 保持一致，我們將在本季度就 ET 患者的給藥策略達成一致。一旦我們掌握了皮下製劑的生物利用度和給藥策略這兩個數據，我就可以回答你關於劑量和輸注時間的問題了。您應該還記得，我們​​去年底（我記得是去年十月）與 Enable 公司簽署了合作協議，使用 enFuse 設備，該設備可以讓患者在家中進行大量輸液，而無需前往醫生辦公室。它是一種可自行使用的裝置。

It takes about 10, 15 minutes, and the patient does it without any major discomfort. It's not a device that patients have to work continuously. They just do it at the time of the infusion and then they can remove it and throw it away.

大約需要 10 到 15 分鐘，患者不會感到任何明顯的不適。這不是患者需要持續使用的設備。他們只是在輸液的時候做這件事，然後就可以把它取出來丟掉。

So we believe that, that device will give us the alternative to really have a very simple subcutaneous infusion experience for patients, pretty much regardless of the dose. But in terms of specifics, we need a little bit more data to fully answer the question. We'll have that data over the course of the year.

因此我們相信，無論劑量如何，該設備將為患者提供非常簡單的皮下輸注體驗。但就具體細節而言，我們需要更多的數據才能完全回答這個問題。我們將在一年內陸續獲得這些數據。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

On the mutant selective JAK inhibitor, I know you've made some comments recently about IC35 being the exposure target that's needed to see clinical benefit. Can you just elaborate on why you think that's the right target exposure, if that's somehow limited by cross-reactivity on wild type? And just whether you think the new formulation can get you meaningfully higher than IC35?

關於突變選擇性 JAK 抑制劑，我知道你最近發表了一些評論，認為 IC35 是獲得臨床療效所需的暴露目標。如果這種暴露方式受到野生型交叉反應的限制，您能否詳細說明為什麼您認為這是正確的標靶暴露方式？你認為新配方能否顯著提高 IC35 的效果？

Yes, it's an excellent question. So the reason for the IC35 focus with the 058 program is because that's specific to 058. It's not about the target. It's about the selectivity of the molecule that we have in the clinic. And that's what with the animal model data suggests that there is a window, the ideal window of selectivity between the effect on the mutant -- the V617 mutant and the wild type is around the IC35.

是的，這是一個很好的問題。因此，IC35 與 058 計劃的重點在於 058 計劃。重點不在於目標。關鍵在於我們臨床上使用的分子的選擇性。動物模型數據表明，存在一個窗口，即對突變體（V617 突變體）和野生型產生影響的理想選擇性窗口，其值在 IC35 附近。

So we believe that with the current formulation based on preclinical data, we should be able to achieve that level of exposure. That question will be answered relatively quickly over the course of this year, and we believe we'll then have clinical data in the second half of 2026. But the IC35 point is related to the selectivity of the molecule.

因此，我們相信，根據臨床前數據，採用目前的配方，我們應該能夠達到該暴露水準。這個問題將在今年內很快得到解答，我們相信我們將在 2026 年下半年獲得臨床數據。但 IC35 點與分子的選擇性有關。

Now -- as I mentioned, I think, towards the end of last year, and we reiterated at JPMorgan earlier this year, we do have backup programs in this space. We are fully committed to this target. We believe hitting this target hard will translate into clinical benefit in this patient. So whether it's 058 in the second half of this year, we'll provide clarity on addressing this target or one of the backup programs remains to be seen, but we're fully committed to answering this question.

正如我去年年底提到的，而且我們今年早些時候在摩根大通也重申了這一點，我們在這個領域確實有備用方案。我們全力以赴實現這個目標。我們相信，精準擊中這個目標將為這位患者帶來臨床益處。所以，無論是今年下半年推出 058 版本，還是推出備選方案，我們都會就此目標做出明確說明，但目前還不得而知，不過我們完全致力於回答這個問題。

Kripa Devarakonda, Truist Securities.

Kripa Devarakonda，Truist 證券公司。

I wanted to just get your expectations for povorcitinib in asthma with the Phase II readout coming up. And also, maybe you can help us understand where do you see a place for this drug in the therapeutic landscape? Is it pre-biologic oral or for patients who are refractory? I know it's a little early ahead of the data, but any color you can give would be helpful.

我想了解您對 povorcitinib 治療氣喘的預期，因為 II 期臨床試驗結果即將公佈。另外，您能否幫助我們了解一下，您認為這種藥物在治療領域中處於什麼位置？它是生物製劑前的口服療法，還是用於難治性患者？我知道現在提供數據還為時過早，但您能提供的任何資訊都將有所幫助。

Yes, I'll take the second part of your question, which I think relates to povorcitinib and HS, and then I'll turn it over to Pablo. I think the key here with povorcitinib, think about what's happening in the obesity market right now with an oral pill. There is a lot of energy around Wegovy. Now I'm not suggesting that HS is like obesity. But there's a couple of hundred thousand people in the United States being diagnosed and treated with HS.

是的，我會回答你問題的第二部分，我認為這部分與 povorcitinib 和 HS 有關，然後我會把它交給 Pablo。我認為，對於 povorcitinib 來說，關鍵在於要考慮目前口服藥物在肥胖症市場上的發展狀況。Wegovy周圍充滿了活力。我並不是說化膿性汗腺炎和肥胖一樣。但在美國，有幾十萬人被診斷出患有化膿性汗腺炎 (HS) 並接受治療。

Only about 25% of those patients are taking an advanced systemic and the only advanced systemics available are the IL-17s and TNFs. There's 50,000 people. There's 150,000 people using products that are not approved for HS, antibiotics, and steroids. Our ability to drive sales of povorcitinib is to get to that group, that 75% of the market, where they haven't advanced to a biologic, they're not getting complete control with an antibiotic or a steroid.

只有大約 25% 的患者正在接受高階全身性治療，而目前可用的高階全身性治療藥物只有 IL-17 和 TNF。這裡有5萬人。有 15 萬人正在使用未經批准用於治療化膿性汗腺炎、抗生素和類固醇的產品。我們推動 povorcitinib 銷售的能力在於進入那 75% 的市場，即尚未接受生物製劑治療、無法透過抗生素或類固醇完全控制病情的群體。

So I think the path here is to get to this prebiologic population and 70% of our data are in that population. Povo is tailor-made for this group of patients, and I do expect that there'll be a great deal of trial and adoption. Once that happens, there's, of course, the post-biologic and half the people that are on IL-17 don't get a full response, and so there are going to be patients there.

所以我認為，解決之道在於找到這個前生物學群體，而我們 70% 的數據都來自這個群體。Povo 是為這類患者量身定制的，我預計它會得到大量的試用和推廣。一旦這種情況發生，當然就會出現生物製劑治療後的情況，接受 IL-17 治療的患者中有一半無法獲得完全療效，因此會有一些患者需要繼續治療。

Next thing we have to do as a company is create an experience for patients and physicians and make it easy to get the product. And that means making sure we verify benefits, we get the time to first fill is really short. We clear PAs, and we reduce the abandonment rate. And if we do those two things, povorcitinib is going to be a major driver of revenue for this company in HS. And then, of course, you layer in PN and vitiligo, and we have a very sizable product. That's how I would think about it. If you want to turn to the asthma piece.

接下來，我們公司要做的是為患者和醫生創造良好的體驗，並讓他們更容易獲得產品。這意味著，為了確保我們核實福利，我們第一次填寫表格的時間非常短。我們清除了 PA，降低了放棄率。如果我們做到這兩點，povorcitinib 將成為這家公司在 HS 領域的主要收入驅動力。當然，再加上PN和白斑，我們就得到了一個非常龐大的產品。我也會這麼想。如果你想了解氣喘那部分內容。

So look, we know from all the data that we've been generating over the past several years across a range of indications that povorcitinib is a very strong, very potent anti-inflammatory medicine. In that context and knowing that asthma is an inflammatory disease, I think there's a strong rationale. There was a strong rationale when the study was started to develop povorcitinib in asthma, particularly in patients, obviously that don't respond to inhaled corticosteroids to a long-acting beta agonist and particularly in patients with low eosinophilic asthma.

所以你看，我們從過去幾年在各種適應症中產生的所有數據中得知，povorcitinib 是一種非常強效的抗發炎藥物。在這種背景下，考慮到氣喘是一種發炎性疾病，我認為這是有充分理由的。這項研究的初衷是開髮用於治療氣喘的 povorcitinib，特別是用於對吸入性皮質類固醇和長效β受體激動劑無反應的患者，特別是用於治療嗜酸性粒細胞減少的氣喘患者。

Now we are conducting a well-designed, randomized Phase II study. We will have the data later this year. And based on that, we'll decide next steps. But obviously, there was a strong scientific rationale to do that, and we look forward to sharing the data later this year.

現在我們正在進行一項設計完善的隨機 II 期研究。我們將在今年稍後獲得數據。我們將以此為依據，決定下一步措施。但顯然，這樣做有充分的科學依據，我們期待在今年稍後分享這些數據。

Thank you. We reached the end of our question-and-answer session. And 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.

謝謝。我們的問答環節結束了。女士們、先生們，今天的電話會議和網路直播到此結束。現在您可以斷開線路了，祝您有美好的一天。感謝您今天的參與。