英賽德 (INCY) 2025 Q2 法說會逐字稿

Greetings and welcome to the Incyte second-quarter 2025 earnings conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 Incyte 2025 年第二季財報電話會議及網路直播。 （操作員指示）溫馨提示：本次會議正在錄製中。

It's now my pleasure to turn the whole over to Greg Shertzer, Senior Director of Investor Relations. Please go ahead.

現在，我很高興將發言權交給投資者關係高級總監Greg Shertzer。請發言。

Thank you, Kevin. Good morning and welcome to Incyte's second-quarter 2025 earnings conference call. Before we begin, I'd 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，凱文。早安，歡迎參加Incyte 2025年第二季財報電話會議。在開始之前，我建議大家造訪我們網站的「投資者」版塊，查看新聞稿、相關財務表格以及今天討論內容的後續投影片。

On today's call, I am joined by Bill, Christiana, and Pablo, who will deliver our prepared remarks. Matteo, Mohamed, and Steven will also be available for the Q&A.

今天的電話會議，比爾、克里斯蒂安娜和巴布羅將與我一同發表準備好的演講。馬特奧、穆罕默德和史蒂文也將出席問答環節。

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. I will now hand the call over to Bill.

我想指出的是，我們將基於當前的預期和信念做出前瞻性陳述。這些陳述受某些風險和不確定性的影響，我們的實際結果可能有重大差異。我建議您查閱我們提交給美國證券交易委員會 (SEC) 的文件中討論的風險因素，以獲取更多詳細資訊。現在我將把電話交給比爾。

Thanks, Greg, and good morning, everyone. Before I get started, and on behalf of the Incyte management team and the employees, I'd like to thank and recognize Hervé Hoppenot for his leadership and commitment to Incyte over 10 years. His contributions to this company were invaluable and greatly appreciated, and we wish him the best in his retirement.

謝謝，格雷格，大家早安。在開始之前，我謹代表Incyte管理團隊和全體員工，感謝並認可埃爾韋·霍佩諾特(Hervé Hoppenot)十年來對Incyte的領導和貢獻。他對公司的貢獻無比寶貴，我們深表感謝，並祝他退休後一切順利。

As you know, I started at Incyte very recently, roughly 30 days ago, and so before jumping into the quarterly results, I'd like to touch on two fundamental questions I've been asked since joining Incyte. The first one is what specifically attracted me to the company; and second, what are my initial thoughts on strategic priorities.

大家知道，我加入Incyte的時間不長，大概30天前。所以在開始討論季度業績之前，我想先談談自從加入Incyte以來我被問到的兩個基本問題。第一個問題是，是什麼特別吸引我加入Incyte？第二個問題是，我對公司策略重點的初步想法是什麼？

In response to the first question, I naturally studied the company and the business in great detail and spoke to many different stakeholders, including physicians, patients, and investors before joining. And my initial impression is that Incyte has all the intrinsic characteristics of a high-quality growth business. That is, the potential for new meaningful product flow, attractive markets, R&D and commercial capabilities, and a strong balance sheet.

在回答第一個問題時，我自然而然地對這家公司及其業務進行了深入研究，並在加入之前與許多利益相關者進行了交流，包括醫生、患者和投資者。我最初的印像是，Incyte 具備高品質成長型企業的所有內在特徵，即：潛在的新的、有意義的產品流、具有吸引力的市場、研發和商業能力，以及強勁的資產負債表。

I believe there's a foundation in place and a path to value creation, but time is of the essence. The non-trivial challenge Incyte faces is navigating the company through 2029 and transitioning to a new set of durable product growth drivers.

我相信基礎已經紮實，價值創造之路也已鋪就，但時間至關重要。 Incyte面臨的重大挑戰是如何帶領公司度過2029年，並轉型至一套新的、持久的產品成長動力。

On the potential for meaningful new product flow, Incyte has several important product launches between now and 2030. These products, of course, will vary in size. Some will contribute substantially and others incrementally to growth.

關於有意義的新產品流的潛力，Incyte 從現在到 2030 年將推出幾款重要的產品。當然，這些產品的規模會有所不同。有些產品將對成長做出重大貢獻，而有些產品則將逐步成長。

But either way, there's substrate here. Marketed products Opzelura, Niktimvo, Monjuvi, and pipeline compounds like '989, our mutant CALR monoclonal antibody, and Povorcitinib, our JAK1 specific inhibitor, have the potential to drive future sales growth and form the company's core. More work remains, of course, but we've made progress with these compounds scientifically and commercially.

但無論如何，這其中都有底物。已上市的產品Opzelura、Niktimvo、Monjuvi，以及正在研發的化合物，例如我們的突變型CALR單株抗體'989和我們的JAK1特異性抑制劑Povorcitinib，都有潛力推動未來的銷售成長，並構成公司的核心業務。當然，我們還有更多工作要做，但我們在這些化合物的科學和商業化方面都取得了進展。

Opzelura is showing strong broad-based growth today across AD and vitiligo, has close to 20,000 prescribers, and has the potential for new indications in the coming years. Niktimvo is off to a very strong start. Phase 1 results with '989 and ET are promising, and we will share data on MF at the end of the year. And finally, Povorcitinib could support at least three different indications.

Opzelura 目前在阿茲海默症 (AD) 和白斑領域表現出強勁的廣泛增長，擁有近 2 萬名處方醫生，並有可能在未來幾年內獲得新的適應症。 Niktimvo 的開局非常強勁。 989 和 ET 的一期臨床試驗結果令人鼓舞，我們將在年底分享其在骨髓纖維化 (MF) 方面的數據。最後，Povorcitinib 至少可以支持三種不同的適應症。

Next, Incyte operates in two of the most structurally attractive markets in the industry: hematology and oncology, and immunology. They're built on solid foundations of science, need, and opportunity, and we have differentiated knowledge and capabilities in these areas, and we'll focus on them.

其次，Incyte 的業務涵蓋業內最具結構吸引力的兩個市場：血液學和腫瘤學，以及免疫學。這兩個市場建立在堅實的科學、需求和機會基礎上，我們在這些領域擁有差異化的知識和能力，我們將專注於此。

And finally, Incyte has well developed high-quality R&D and commercial capabilities. Yes, there have been R&D setbacks, and we need to convert science into regulatory approvals and business results, but I believe our discovery and development capabilities in our core areas are a competitive advantage.

最後，Incyte 擁有完善的高品質研發和商業化能力。誠然，研發過程中也遇到一些挫折，我們需要將科學成果轉化為監管部門的批准和商業成果，但我相信，我們在核心領域的發現和開發能力是我們競爭優勢。

Now regarding our strategic priorities, here's my initial thinking, and I will come back to you in the coming months with more specifics on the direction we plan to take the company strategically, operationally, and financially.

現在關於我們的策略重點，這是我的初步想法，我將在未來幾個月內向您提供更多關於我們計劃在策略、營運和財務方面帶領公司前進的方向的具體資訊。

We intend to build a comprehensive plan for acceleration that goes beyond just filling a revenue gap. We'll take a fresh look at this business, including our R&D productivity, operating expenses, and capital allocation, and dedicate resources to accelerating product flow and growth.

我們計劃制定一個全面的加速計劃，而不僅僅是填補收入缺口。我們將重新審視這項業務，包括我們的研發效率、營運支出和資本配置，並投入資源來加速產品流程和成長。

My framework for the business will likely have the following set of priorities. First, take care of the core. That's straightforward. Driving utilization of our major products in the short term is necessary for long-term success. Second, accelerate product development. Pablo and I have spent many hours on this topic. It's almost all we talk about.

我的業務框架可能會有以下幾個優先事項。首先，專注於核心業務。這很簡單。短期內提高我們主要產品的利用率對於長期成功至關重要。其次，加速產品開發。 Pablo 和我在這個話題上花了很多時間。這幾乎是我們討論的全部內容。

Our mid- to late-stage pipeline has the potential to unlock the next phase of growth for Incyte, but there are still unanswered questions, which is not uncommon. '989 is arguably the most scientifically promising asset in the MPN space as a targeted mutation-specific approach. Our success will depend on translating early Phase 1 data into a regulatory approval and a marketed product.

我們處於中後期研發管線的研發線有潛力為Incyte開啟下一階段的成長，但仍有一些問題尚未解答，這並不罕見。 ‘989作為一種針對特定突變的標靶療法，可以說是MPN領域最具科學前景的資產。我們的成功取決於能否將早期的1期臨床試驗數據轉化為監管部門的核准和上市產品。

The medical need and the market potential for '989 is significant. If we're successful, '989 should trigger a fundamental shift in the treatment of MPNs like we've seen in other cancers.

989的醫療需求和市場潛力巨大。如果我們成功，989應該會引發骨髓增生性腫瘤（MPN）治療的根本性變革，就像我們在其他癌症治療中看到的那樣。

For Povorcitinib, we have a clear and credible path to turning this into a major product for Incyte. Its success will be predicated on execution in areas where Povorcitinib can have differentiation such as HSPN and vitiligo.

對於Povorcitinib，我們有清晰可靠的途徑將其打造成Incyte的主力產品。其成功取決於Povorcitinib在特定領域（例如HSPN和白斑症）的差異化執行力。

In HS, Povorcitinib could be the first oral option, which is perhaps the most challenging disease in dermatology. It's not like IL-3 mediated psoriasis or IL-4/-13 mediated AD. It's more complex, involves more pathways. Treatment success is variable, and so a new treatment option like Povorcitinib should be very marketable.

對於HS，Povorcitinib可能是首個口服藥物，而HS可能是皮膚科中最具挑戰性的疾病。它不同於IL-3介導的銀屑病或IL-4/-13介導的AD。它更複雜，涉及更多通路。治療成功率各不相同，因此像Povorcitinib這樣的新治療方案應該非常具有市場潛力。

As it relates to our early-stage pipeline, the scientific rationale behind CDK2, G12D, TGFßR2×PD-1, for select solid tumors, among others is strong, but as you know, early-stage projects inherently involve uncertainties.

就我們早期研發管線而言，CDK2、G12D、TGF-R2-PD-1 等藥物在治療特定實體瘤的科學原理十分強大，但正如您所知，早期計畫本身就存在不確定性。

We'll be continuously assessing these and other programs. They'll be put through a framework to be scored and compared to other programs based on strategic importance, PTRS, commercial potential, and return on investment. And I recognize that every use of capital, R&D capital, is an opportunity cost for other uses.

我們將持續評估這些項目和其他項目。這些項目將透過一個框架進行評分，並根據策略重要性、PTRS、商業潛力和投資回報率與其他項目進行比較。我體認到，每項資本的使用，包括研發資本的使用，都會為其他用途帶來機會成本。

Third, capital allocation. We're generating significant cash flow and have a growing balance sheet. The first call on capital will be the core business, our marketed products. The second is the late-stage pipeline, and the third is business development.

第三，資本配置。我們正在產生大量現金流，資產負債表也不斷成長。首先需要資本的是核心業務，也就是我們已上市的產品。其次是後期研發管線，第三是業務發展。

Sometimes our best investments will be inside the company, and other times the reverse will be true. We'll have a governance mechanism for allocating capital internally and externally to ensure long-term growth and maximize shareholder value.

有時我們最好的投資是在公司內部，有時則相反。我們將建立一套治理機制，用於內部和外部資本配置，以確保長期成長並最大化股東價值。

Regarding business development, we'll look hard at finding de-risks, pre-revenue, or revenue stage opportunities. As there are very few positive asymmetrical opportunities out there, and it's easy to mistakenly turn $1 into $0.50. We'll be careful about where and how much capital we put to work, but when strategically sourced, appropriately priced, and well executed, BD can create a lot of value. We will have a well-defined framework for BD and we will look for opportunities that fit that framework.

關於業務拓展，我們將努力尋找低風險、未獲利或處於獲利階段的機會。由於積極的非對稱機會非常少，很容易將1美元誤認為0.5美元。我們會謹慎選擇資金投入的方向和金額，但如果策略性地尋找資金、合理的定價和良好的執行，業務拓展可以創造巨大的價值。我們將制定明確的業務拓展框架，並尋找符合該框架的機會。

Finally, it's important to keep a close eye on execution. Converting science and strategic plans to results is the job. We'll run the business at a detailed level, enhance the quality and speed of decision making inside the company, and manage our expenses in a disciplined way, which means focusing on doing more with less versus more with more. I look forward to sharing more details on our strategic framework later this year.

最後，密切關注執行至關重要。將科學和策略規劃轉化為成果才是關鍵。我們將以精細化的方式經營業務，提高公司內部決策的品質和速度，並以嚴謹的方式管理我們的開支，這意味著我們將專注於用更少的資源做更多的事情，而不是用更多的資源做更多的事情。我期待在今年稍後分享更多關於我們戰略框架的細節。

Now moving to our second-quarter results, which Christiana will review next, Jakafi demand remains very strong across three indications. Opzelura growth was exceptional across two indications, and the Niktimvo launch is exceeding expectations with rapid adoption among BMT centers, reinforcing its commercial potential. The growth prospects for these products are excellent if we continue to execute.

現在來看看我們第二季的業績，Christiana 將在接下來進行回顧。 Jakafi 在三種適應症上的需求依然強勁。 Opzelura 在兩種適應症上實現了卓越的成長，Niktimvo 的上市也超越了預期，在 BMT 中心迅速普及，增強了其商業潛力。如果我們繼續執行，這些產品的成長前景將非常光明。

On the R&D front, we made excellent progress. We will release Phase 1 data on '989 and MF at the end of the year to supplement the data we presented at EHA and ET. We expect an FDA approval for Opzelura and pediatric patients 2 to 11 years of age with mild to moderate AD in September. And importantly, the pivotal trials for Povorcitinib and vitiligo and PN, and combination trials with axatilimab and GVHD are enrolling on track.

在研發方面，我們取得了卓越的進展。我們將在年底發布989和MF的I期數據，以補充我們在EHA和ET上展示的數據。我們預計Opzelura和2至11歲輕度至中度AD患童的治療方案將於9月獲得FDA批准。更重要的是，Povorcitinib治療白斑症和PN的關鍵性試驗，以及與Axatilimab聯合治療移植物抗宿主疾病（GVHD）的試驗正在按計劃進行。

With that, I'd like to turn the call over to Christiana, who will provide the second-quarter commercial and financial update.

說完這些，我想把電話轉給克里斯蒂安娜，她將提供第二季的商業和財務更新。

Thank you, Bill, and good morning, everyone. In Q2, we delivered strong financial results with total product revenues of $1.06 billion representing an increase of 17% year over year, driven by continued demand growth for Jakafi and Opzelura as well as a contribution from the ongoing commercial launch of Niktimvo. Total revenues were $1.2 billion, up 16% versus the same period last year.

謝謝比爾，大家早安。第二季度，我們取得了強勁的財務業績，產品總收入達10.6億美元，年增17%，這得益於Jakafi和Opzelura的持續需求成長，以及Niktimvo的持續商業化上市。總收入達12億美元，年增16%。

Turning to Jakafi on slide 9, Jakafi net product revenue was $764 million for the second quarter, representing an 8% growth year over year, driven by paid demand, which also increased 8% versus the prior year period. Demand for Jakafi continued to grow across all indications.

來看第9張幻燈片上的Jakafi。 Jakafi第二季淨產品營收為7.64億美元，年增8%，主要得益於付費需求，付費需求也比去年同期成長了8%。所有適應症對Jakafi的需求均持續成長。

Channel inventory levels ended the quarter within the normal range. As a result of the strong demands seen in the first half of the year, we are raising our full-year revenue guidance for Jakafi to a new range of $3 billion to $3.5 billion.

本季末，渠道庫存水位處於正常範圍內。鑑於上半年需求強勁，我們將 Jakafi 的全年營收預期上調至 30 億美元至 35 億美元。

Turning now to Opzelura on slide 10, total net product revenue for the second quarter was $164 million representing a 35% increase year over year. US net product revenue of $132 million was up 19% year over year, driven by increased patient demand and refills in both atopic dermatitis and vitiligo. Channel inventory levels ended the quarter within normal range.

現在來看第10張投影片上的Opzelura，第二季產品淨總收入為1.64億美元，年增35%。美國市場淨產品收入為1.32億美元，年增19%，這得益於患者需求的成長以及異位性皮膚炎和白斑藥物的續藥需求。本季末，渠道庫存水位處於正常範圍內。

Ex US net product revenues of $32 million [loss] were driven by continued uptake in France and Germany as well as the recent launches in Italy, Spain, and Canada. In France and Italy, Opzelura has seen very rapid adoption.

除美國外，淨產品收入為3,200萬美元（虧損），這得益於法國和德國市場的持續成長，以及近期在義大利、西班牙和加拿大市場的推出。在法國和義大利，Opzelura的普及速度非常快。

Turning to slide 11 in Niktimvo launch. Niktimvo net product revenues in the second quarter were $36 million driven by high patient need and strong commercial execution. We continue to see positive launch metrics with widespread product awareness and interest. We have achieved roughly 82% account penetration with rapid and broad uptake in BMT centers across the US.

翻到第11張投影片，Niktimvo的發表會。 Niktimvo第二季的淨產品收入為3,600萬美元，得益於患者需求的旺盛和強勁的商業執行力。我們持續看到正面的產品發布指標，以及廣泛的產品認知度和興趣。我們的帳戶滲透率已達到約82%，並在全美各地的骨髓移植中心迅速普及。

Since the beginning of the launch, over 4,000 infusions have been administered to an estimated 700 patients, representing approximately 10% of the third-line plus GVHD market. Of all the patients that went on Niktimvo, approximately 80% to 90% remain on therapy today.

自上市以來，已為約700名患者進行了超過4000次輸注，約佔三線及以上移植物抗宿主疾病（GVHD）治療市場的10%。在所有接受Niktimvo治療的患者中，約有80%至90%至今仍在接受治療。

Turning now to other hematology and oncology products on slide 12. Net product revenues for the second quarter were $131 million representing a 66% year-over-year increase. This is primarily driven by the commercial launch of Niktimvo, as well as increased contribution from Zynyz following the approval in SCAC.

現在就來看看幻燈片12上的其他血液學和腫瘤學產品。第二季淨產品營收為1.31億美元，年增66%。這主要得益於Niktimvo的商業化發布，以及Zynyz在SCAC獲得批准後貢獻的增加。

As a result of the strength of the Niktimvo launch, higher demand for Zynyz, and the earlier than anticipated approval for Monjuvi in FL, we are raising our full-year revenue guidance for other oncology products to a new range of 400 -- $500 million to $520 million.

由於 Niktimvo 的強勁上市、Zynyz 需求的增加以及 Monjuvi 在佛羅裡達州獲得比預期更早的批准，我們將其他腫瘤產品的全年收入預期上調至 4 億至 5 億美元至 5.2 億美元的新範圍。

Moving on to slide 13 and our operating expenses. During the second quarter, we recorded a benefit of $242 million from the contract dispute settlement with Novartis relating to Jakafi royalty payments through the first quarter of 2025. The settlement also resulted in a reduction in COGS driven by an ongoing 50% reduction in the royalty rate payable to Novartis. As a result, we are reducing the lower end of our COGS guidance. The revised guidance range is now 8% to 9% of net product revenues.

接下來是第13張投影片，以及我們的營運費用。在第二季度，我們與諾華就Jakafi特許權使用費達成的合約糾紛和解協議，為我們帶來了2.42億美元的收益，該糾紛將持續到2025年第一季。由於諾華應支付的特許權使用費率持續降低了50%，和解協議也降低了我們的銷售成本。因此，我們正在下調銷售成本指引的下限。修訂後的指導範圍目前為淨產品收入的8%至9%。

Shifting now to R&D. Total R&D expenses on a GAAP basis were $495 million for the second quarter. Excluding the one-time (inaudible) cost in 2024 and other one-time expenses in both years, R&D expenses increased 8% year over year, driven by continued investment in our late-stage development assets.

現在轉向研發。以美國通用會計準則 (GAAP) 計算，第二季研發總支出為 4.95 億美元。扣除 2024 年的一次性（聽不清楚）成本以及兩年內的其他一次性支出，研發支出年增 8%，這得益於我們對後期開發資產的持續投資。

In the first half of the year, we entered into two new development collaborations with Genesis and Biotheryx. As a result of the upfront and ongoing expenses related to these new collaborations, we are increasing a full-year guidance for R&D by $35 million to a new range of $1.965 billion to $1.995 billion.

上半年，我們與Genesis和Biotheryx達成了兩項新的開發合作。由於這些新合作產生的前期和持續支出，我們將全年研發預算調高3,500萬美元，至19.65億美元至19.95億美元。

Moving to SG&A. Total GAAP SG&A expenses were $331 million for the second quarter. Excluding the one-time costs for the prior year, GAAP SG&A expenses increased 16% year over year, primarily driven by increased legal costs related to the Novartis contract dispute settlement and other matters and timing of certain consumer marketing activities.

再來說銷售、一般及行政費用 (SG&A)。第二季 GAAP 銷售、一般及行政費用 (SG&A) 總額為 3.31 億美元。扣除上年的一次性費用後，GAAP 銷售、一般及行政費用年增 16%，主要原因是與諾華合約糾紛解決相關的法律費用增加，以及其他事項以及某些消費者行銷活動的時間安排。

Finally, we continue to execute on our commitment to grow operating expenses at a slower pace than revenues. Ongoing operating expenses in the second quarter of 2025 increased 13% year over year compared to a 16% increase in revenues during the same period, leading to continued increase in operating leverage and margins.

最後，我們持續履行承諾，營運費用的成長速度低於收入的成長速度。 2025年第二季度，持續營運費用年增13%，而同期營收成長16%，這推動了營運槓桿和利潤率的持續提升。

Given the very strong performance of our commercial portfolio in the first half of the year, and based on our updated guidance for the year, we expect net product revenues for the full year to grow at a rate of 14% to 17% year over year and ongoing operating expenses to grow at a rate of 5% to 7%, leading to further expansion in operating margins.

鑑於我們商業產品組合在今年上半年表現非常強勁，並且根據我們最新的年度指引，我們預計全年淨產品收入將同比增長 14% 至 17%，持續運營費用將增長 5% 至 7%，從而進一步提高運營利潤率。

I'll now turn the call over to Pablo for an R&D update.

現在我將把電話轉給 Pablo 來報告研發最新情況。

Thank you, Christiana, and good morning, everyone. As we highlighted a year ago when we summarized on this slide, our portfolio remains on track to deliver more than 10 launches by 2030. Moving to slide 16. The Phase 1 data in essential thrombocytemia for INCA033989, our mutant CALR monoclonal antibody was presented at EHA 2025. '989 is the first truly targeted therapy for a subset of patients with MPNs that includes 25% of patients with essential thrombocytemia and 35% of patients with myelofibrosis.

謝謝克里斯蒂安娜，大家早安。正如我們一年前在這張投影片上總結時所強調的那樣，我們的產品組合仍有望在2030年前推出10多個產品。轉到第16張投影片。我們的突變型CALR單株抗體INCA033989在治療原發性血小板增多症（EST）的1期數據已在EHA 2025上進行了展示。 989是第一個真正針對MPN患者亞群的標靶療法，其中包括25%的EST患者和35%的骨髓纖維化患者。

Importantly, this data set demonstrated the normalization of platelet counts in patients with ET, which is consistent with the mechanism of action of '989 and a key point of differentiation from [ceroductive] therapies. '989 was very well tolerated with only 1 out of 49 patients discontinued therapy. It is very reassuring that at this point in the development of '989, it appears to have an excellent safety profile.

重要的是，該資料集證實了ET患者的血小板計數恢復正常，這與'989的作用機制相符，也是其與[癌症治療]療法的關鍵區別點。 '989的耐受性非常好，49例患者中僅有1例停止治療。令人欣慰的是，在'989的研發階段，它似乎具有出色的安全性。

We also observed rapid and sustained reductions in VAF in most patients despite the short follow up for patients in the highest dose cohorts. We believe this data will continue to improve as it matures, delivering an important outcome for patients.

我們也觀察到，儘管最高劑量組患者的追蹤時間較短，但大多數患者的VAF均快速且持續下降。我們相信，隨著研究的成熟，這些數據將持續改善，為患者帶來重要的療效。

Treatment with '989 also resulted in a reduction in mutant CALR positive megakaryocytes in the bone marrow as well as a reduction in mutant-CALR positive, CD34 positive stem and progenitor cells in peripheral blood, confirming the potential of '989 to be a disease-modifying therapy that offers a potential path to a cure.

'989 治療還導致骨髓中突變 CALR 陽性巨核細胞減少，以及外周血中突變 CALR 陽性、CD34 陽性幹細胞和祖細胞減少，證實了 '989 作為一種疾病修飾療法的潛力，為治癒疾病提供了潛在的途徑。

On slide 17, let me summarize the key steps for the '989 development plan. We will advance this program with great urgency with the goal of starting pivotal trials in ET by early 2026. We continue to gather data and have expanded certain dose cohorts to better understand what the optimal doses for further development. We are committed to presenting data in MF as monotherapy and in combination with Ruxolitinib by the end of the year.

在第17張投影片上，請容許我總結「989」開發計畫的關鍵步驟。我們將全力推動該計劃，目標是在2026年初啟動針對胚胎性內皮功能障礙（ET）的關鍵性試驗。我們將繼續收集數據，並擴大了某些劑量組，以便更好地了解進一步開發的最佳劑量。我們致力於在年底前公佈針對骨髓纖維化（MF）的單藥治療以及與魯索替尼（Ruxolitinib）聯合治療的數據。

Additionally, we have established a collaboration with QIAGEN to develop a co-diagnostic across MPNs, with an initial focus in CALR mutations. Importantly, we continue to develop a subcutaneous formulation, and that work is ongoing. We believe that initially, the IV formulation every two weeks is acceptable, but we'll work to advance a subcu in parallel.

此外，我們與 QIAGEN 合作，開發一種適用於多發性骨髓瘤 (MPN) 的聯合診斷方法，初期將重點放在 CALR 突變。重要的是，我們正在繼續開發皮下注射劑型，這項工作仍在進行中。我們認為，初期每兩週一次的靜脈注射劑型是可以接受的，但我們將同步推進皮下注射劑型的開發。

Turning to our dermatology portfolio, starting on slide 18. I'm pleased to share an important update on Ruxolitinib cream. As you know, Opzelura is currently approved in the US for the treatment of adult and adolescent patients with mild to moderate atopic dermatitis and vitiligo; and in Europe, for the treatment of vitiligo.

從第18張投影片開始，我們來談談我們的皮膚科產品組合。我很高興分享關於魯索利替尼乳膏的重要更新。如大家所知，Opzelura目前在美國已獲準用於治療成人和青少年輕度至中度異位性皮膚炎和白斑患者；在歐洲，Opzelura也獲準用於治療白斑症。

Today, as we announced the top-line results from the pivotal Phase 3 TRuE-AD4 study which evaluated Ruxolitinib cream in adult patients with moderate atopic dermatitis with extensive body surface area involvement of 10% to 20% and significantly impair quality of life with a DLQI greater than 10.

今天，我們公佈了關鍵性 3 期 TRuE-AD4 研究的頂線結果，該研究評估了魯索利替尼乳膏對中度特應性皮膚炎成年患者的效果，這些患者的體表面積受累面積達 10% 至 20%，並且生活品質顯著受損，DLQI 大於 10。

I'm happy to report that the TRuE-AD4 study met its co-primary endpoints at week 8, with statistically significantly larger proportion of patients receiving 1.5% Rux cream compared to vehicle, achieving both IGA-TS and EASI75. At week 8 Rux cream demonstrated a vehicle adjusted difference in IGA-TS of 47.6% and a vehicle adjusted difference in EASI75 or 51.4%, both highly statistically significant.

我很高興地報告，TRuE-AD4研究在第8週達到了其共同主要終點，使用1.5% Rux乳膏的患者中，達到IGA-TS和EASI75的患者比例顯著高於使用賦形劑的患者，且統計學上顯著差異顯著。第8週，Rux乳膏經賦形劑校正後的IGA-TS差異為47.6%，經賦形劑校正後的EASI75差異為51.4%，兩者皆具有高度統計意義。

In addition, the study met all key secondary endpoints, further reinforcing the efficacy profile of Ruxolitinib cream in this patient population. Importantly, the safety profile observed in TRuE-AD4 was consistent with previously reported data in atopic dermatitis. Ruxolitinib cream was well tolerated, and no new safety signals were observed.

此外，該研究達到了所有關鍵次要終點，進一步鞏固了魯索替尼乳膏在該患者群體中的療效。重要的是，TRuE-AD4研究中觀察到的安全性與先前報告的異位性皮膚炎數據一致。魯索替尼乳膏耐受性良好，未觀察到新的安全性訊號。

This result confirms that Ruxolitinib cream is a highly effective treatment option for patients with moderate AD who are eligible for systemic therapies. Based on the results of the study, plans are underway to submit a Type 2 variation for Opzelura in Europe, where there's a strong demand for innovative topical therapies in patients that have failed topical corticosteroids or topical calcineurin inhibitors.

這項結果證實，對於適合接受全身性治療的中度AD患者，魯索利替尼乳膏是一種高效的治療選擇。基於該研究結果，我們計劃在歐洲提交Opzelura的2型變異申請。歐洲對局部皮質類固醇或局部鈣調磷酸酶抑制劑治療失敗患者的創新局部療法需求強勁。

Looking ahead, we plan to present the full Phase 3 top-line results at an upcoming medical meeting, and we look forward to engaging with regulators to discuss next steps for potential label expansion.

展望未來，我們計劃在即將召開的醫學會議上展示完整的第三階段頂線結果，並期待與監管機構合作討論潛在標籤擴展的後續步驟。

Moving to slide 19 and the near-term opportunities for Povorcitinib. We're advancing Povorcitinib in three indications and believe this represents significant opportunities for near-term revenue and long-term value creation. The positive Phase 3 data in patients with moderate to severe HS, which affects over 300,000 patients in the US will be our first submission for Povorcitinib, and will support worldwide regulatory filings in 2026.

轉到第19張投影片，Povorcitinib的近期機會。我們正在推動Povorcitinib在三種適應症中的研究，並相信這代表著近期收入和長期價值創造的重要機會。針對中度至重度HS患者的3期臨床試驗數據積極，該疾病影響著美國超過30萬患者，這將是我們首次提交Povorcitinib的上市申請，並將於2026年支持其全球監管備案。

The Phase 3 studies in patients with vitiligo and Prurigo Nodularis are progressing well, and we anticipate presenting data in 2026, with potential approvals in 2027. 2025 is a pivotal year for Incyte with over 18 key milestones, including four new product launches for pivotal trial readouts, at least three Phase 3 study initiations, and seven proof-of-concept study results.

針對白斑症和結節性癢疹患者的 3 期研究進展順利，我們預計將於 2026 年提交數據，並可能於 2027 年獲得批准。 2025 年是 Incyte 的關鍵一年，有超過 18 個關鍵里程碑，包括四個用於關鍵試驗讀數的新產品發布、至少三個 3 期研究啟動和七個概念驗證研究結果。

As shown on slide 20, we have already achieved several of these milestones with multiple important catalysts still to come. I would like to note that the initiation of our BET Phase 3 study is now planned for the second half of the year, pending regulatory feedback and the release of V617F Phase 1 data has shifted from the second half of 2025 to the first half of 2026. We look forward to sharing additional updates on these milestones in the second half of 2025.

如幻燈片20所示，我們已經實現了其中幾個里程碑，但仍有多個重要的催化劑尚未到來。我想指出的是，我們BET三期研究的啟動時間目前已定於今年下半年，但需等待監管機構的回饋。 V617F一期數據的發佈時間也已從2025年下半年延後到2026年上半年。我們期待在2025年下半年分享這些里程碑的更多進展。

I will now turn it back over to Bill for his closing remarks.

現在我將把時間交還給比爾，請他作最後發言。

Thanks, Pablo. To summarize the key takeaways before we open the line for Q&A, our second-quarter sales and growth for our key products were strong, resulting in revenue guidance being increased for the full year. Next, we are making excellent progress with our R&D pipeline both for hematology, oncology, as well as for I&I. Lastly, our focus is converting science and strategic plans into product flow and generating durable revenue and cash flow.

謝謝，Pablo。在開始問答環節之前，我想總結一下要點：我們第二季主要產品的銷售和成長強勁，因此全年營收預期有所上調。其次，我們在血液學、腫瘤學以及免疫學和免疫治療領域的研發管線都取得了顯著進展。最後，我們的重點是將科學和策略計劃轉化為產品流，並創造持久的收入和現金流。

That concludes our prepared remarks. Kevin, please open up the line and give your instructions for Q&A.

我們的準備演講到此結束。凱文，請開始問答環節，並給予您的指示。

(Operator Instructions) Jay Olson, Oppenheimer.

（操作員指示）傑伊·奧爾森，奧本海默。

Congrats on the quarter. And welcome to Bill. It's a pleasure to reconnect with you, especially after having had the pleasure of working with you in the past. Thank you so much for outlining your strategic vision and the rigorous prioritization process that you're planning. Can you just share with us your thoughts on the relative importance of the three therapeutic areas at Incyte oncology, hematology, immunology.

恭喜本季取得佳績。歡迎比爾。很高興再次與您聯繫，尤其是在過去與您共事之後。非常感謝您概述您的策略願景以及您正在規劃的嚴謹的優先排序流程。您能否與我們分享一下您對Incyte腫瘤學、血液學和免疫學這三個治療領域相對重要性的看法？

Do any of those get prioritized in your strategic plan? Or are you agnostic to therapeutic area?

您的策略計劃中會優先考慮這些領域嗎？還是說您對治療領域沒有明確的定義？

Yeah, look, it's a good question, Jay. It should be pretty clear to everybody that MPNs is our most important therapeutic area right now. I think we have, as a company, an asymmetrical advantage in that space. I believe there's a window of opportunity here to completely transform the treatment of that group of blood cancers.

是的，傑伊，你問得好。大家都應該很清楚，多發性骨髓瘤（MPN）是我們目前最重要的治療領域。我認為，作為一家公司，我們在這個領域擁有非對稱優勢。我相信，這是一個徹底改變這類血癌治療方案的機會之窗。

As you know, targeting driver mutations in MPNs is the Holy Grail. I mean, if you talk to a hematologist and ask, would you rather use a targeted monoclonal antibody versus a pathway approach, they'll select the target approach every time.

眾所周知，靶向MPN的驅動突變是治療的關鍵。我的意思是，如果你問血液科醫生，你是更願意使用標靶單株抗體還是通路療法，他們每次都會選擇標靶療法。

We have, potentially the ability to create a series of innovations. Obviously, starting with '989, we have 617, we have a bispecific. We also have compounds in discovery. And when you have an opportunity to sort of dominate and control and never see the market, you got to take advantage of it. And so strategically speaking, that is our number one priority. And I think we can set a new standard of care in MPNs, set what I would describe as a new high watermark.

我們擁有創造一系列創新的潛力。顯然，從989開始，我們擁有617，還有雙特異性抗體。我們還有一些化合物正在研發中。當你有機會主導和控制市場，卻從未真正了解市場時，你必須抓住它。所以從策略上講，這是我們的首要任務。我認為我們可以在多發性骨髓瘤患者（MPN）的治療中樹立新的標準，達到我所說的新的高水準。

Now look, no one should take my word for it. We have to convert, as I said, science into results. And of course, the progress that we're making with '989 has been incredibly important. I think in I&I, I do believe that there's a credible path to building a large product. We're not, for example, with Povorcitinib, copying all the indications for RINVOQ.

現在聽著，沒人該輕信我的話。正如我所說，我們必須將科學轉化為成果。當然，我們在989專案上取得的進展至關重要。我認為在創新與創新領域，我確實相信有一條可靠的途徑可以打造出大型產品。例如，我們不會複製Povorcitinib的所有適應症，例如RINVOQ。

And I do believe we have differentiated knowledge and capabilities in the three immune-mediated skin conditions that we're targeting. And we do have a franchise strategy with Opzelura and Povorcitinib which other companies don't have. The product has the potential to be first in HS, first in vitiligo.

我相信，我們在三種免疫介導皮膚疾病領域擁有差異化的知識和能力。我們針對Opzelura和Povorcitinib制定了其他公司沒有的特許經營策略。該產品有潛力成為HS和白斑領域的首創產品。

And I think Prurigo Nodularis was a disease made for JAKs. And so I like the potential there. And as it relates to our oncology business, Jay, there are certain principles that you have to apply, find the right product first, pick a winning market and make sure that you can defend that position. And we will apply those principles and make sure we make good decisions as it relates to the other programs that we're developing for solid tumors.

我認為結節性癢疹是JAKs引起的疾病。所以我看好它的潛力。 Jay，就我們的腫瘤業務而言，有一些原則必須遵循：首先找到合適的產品，選擇一個成功的市場，並確保你能夠守住這個市場。我們將運用這些原則，確保在我們正在開發的其他實體瘤項目上做出正確的決策。

Beyond those three areas, look, the pressure to fill a pipeline in biopharma, this is true not just at Incyte, but it's true that every company is pretty unforgiving. We're focused on these areas right now. If we were to look at other areas, it would have to make sense strategically and operationally, and I would never stretch the capabilities of the company. But at the end of the day, what we're solving for is new product flow and the knowledge and skills we have in those three areas can be transferable.

除了這三個領域之外，生物製藥領域面臨填補產品線的壓力，這不僅是Incyte面臨的問題，每家公司都面臨著同樣的壓力。我們現在專注於這些領域。如果我們要考慮其他領域，那麼從策略和營運角度來看，這必須是合理的，而且我絕對不會過度擴張公司的能力。但歸根究底，我們解決的是新產品的流程，我們在這三個領域的知識和技能是可以遷移的。

Thank you, Bill.

謝謝你，比爾。

Tazeen Ahmad, Bank of America.

美國銀行的塔津·艾哈邁德（Tazeen Ahmad）。

Thanks for taking my question. I just wanted to get a sense, maybe this is for Pablo on the read through from the CALR data that you saw from ET. And what to maybe expect to see for MF, and then related to that, you're going to show monotherapy as well as combo, but is there a minimum threshold that you're looking for activity on monotherapy if you could just help set expectations for that, we'd appreciate it.

感謝您回答我的問題。我只是想了解一下，也許這是根據您在《ET》上看到的CALR數據，對Pablo的解讀。關於MF，您預期會看到什麼？與此相關的是，您會展示單藥治療和合併治療，但您對單藥治療的療效是否有最低門檻？如果您能幫忙設定預期，我們將不勝感激。

Thank you for the question. Look, let me make a couple of comments here. The important thing to remember is, mechanistically, mutant CALR antibody '989 would work the same way in (inaudible) that it does in ET. So whatever once preconception on the probably a success was before the ET data, it certainly has to increase with ET data in hand.

謝謝你的提問。聽著，我來提幾點意見。需要記住的是，從機制上講，突變型 CALR 抗體 '989 在（聽不清楚）中的作用方式與在胚胎移植（ET）中相同。所以，無論在獲得胚胎移植數據之前，人們對其可能成功的先入為主是什麼，隨著胚胎移植數據的積累，這種先入為主肯定會增強。

A, because of the safety that was so clean; and B, because the efficacy, not only the clear normalization of platelets reduction in VAF and reduction in mutant CALR positive (inaudible) was so clear in the ET data, but because those were our fundamental based on the mechanism of action of the mutant CALR antibody.

A，因為安全性非常明確；B，因為療效，不僅在 ET 數據中 VAF 中血小板減少的明確正常化和突變 CALR 陽性（聽不清楚）的減少非常明確，而且因為這些是我們基於突變 CALR 抗體作用機制的基礎。

So when we have that mechanistic clarity in a set of patients, the probability that will work on a different disease with the same molecular basis is certainly high. The reason why we decided to shift the release of the data and (inaudible) to later this year is, as you pointed out, because we want to have combination data with Ruxolitinib.

因此，當我們在一組患者身上明確了機制後，該藥物對具有相同分子基礎的不同疾病起作用的可能性肯定很高。我們決定將數據發布推遲到今年晚些時候，正如您所指出的，是因為我們希望獲得與魯索利替尼的聯合用藥數據。

As we all know, Ruxolitinib increases survival in first-line patients in patients with MF. And so we believe that the development of '989 in MF will be, at least in part, in combination with Rux, which is why we wanted to have a more comprehensive data set when we present the data later this year.

眾所周知，魯索替尼可以提高第一線治療骨髓纖維化 (MF) 患者的存活率。因此，我們相信，989 在 MF 領域的開發至少在一定程度上將與魯索替尼聯合進行，這也是我們希望在今年稍後公佈數據時能夠獲得更全面的數據集的原因。

In terms of specific numbers, what I would say is we would expect to see improvement in MF in all the basic endpoints that we've discussed over the years in MF patients. Obviously, spleen size reduction in volume reductions, improvement in symptoms, improvement in hemoglobin, perhaps; and we expect to see a component of that in the data release later this year.

就具體數字而言，我想說的是，我們預期MF患者所有基本指標都會有所改善，這些指標我們多年來一直在討論。顯然，脾臟體積縮小、症狀改善、血紅蛋白水平也可能有所改善；我們預計在今年稍後發布的數據中會看到其中一部分指標的改善。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Thank you for taking my question. Just a follow up to two comments that were mentioned earlier. One is initial data for 617 is now expected in the first half of '26. And should we read anything into this delay? And then secondly, you talked about the enthusiasm for Povo in the HS market and its competitive differentiation. Maybe just walk us through that, particularly when you look in the context of superior efficacy that we've seen for some of the currently approved therapies such as BIMZELX.

感謝您回答我的問題。我只是想跟進一下之前提到的兩則評論。第一，617的初始數據預計在2026年上半年公佈。我們應該從這個延遲中解讀出什麼嗎？第二，您談到了Povo在HS市場上的熱情以及它的競爭差異化。能否請您具體介紹一下，特別是結合我們已經看到的一些目前已獲批准的療法（例如BIMZELX）的卓越療效來看。

Great, Salveen. I'll answer the second question, and Pablo wants to take the first question.

太好了，薩爾文。我來回答第二個問題，帕布羅想回答第一個問題。

Certainly. So, this is simply related to the fact that this is a Phase 1 dose escalation study. And you make projections when you start the studies about what dose will give you a certain exposure that will be sufficient in this case, to reach the IC-35, which we've been talking about over the years about inhibiting the mutated cells. It turns out we need higher doses than we expected, you always need a certain amount of follow up in these patients.

當然。所以，這僅與這是一項I期劑量遞增研究有關。在研究開始時，你會預測多少劑量才能達到IC-35的劑量，在這種情況下，IC-35足以達到我們多年來一直在討論的抑制突變細胞的效果。事實證明，我們需要的劑量比預期的要高，而且你總是需要對這些患者進行一定程度的追蹤。

As you know, in MF, data needs to mature a little bit because of those two reasons, the data has moved to the first half of 2026. Importantly, we have opened the study also now to patients with ET and PV. So the study is progressing well. We simply need higher dose levels with a longer follow up to get the kind of data that we're willing to release.

如您所知，由於這兩個原因，MF 的數據需要進一步成熟，數據收集已推遲到 2026 年上半年。重要的是，我們現在也向 ET 和 PV 患者開放了這項研究。因此，研究進展順利。我們只需要更高的劑量水平和更長的追蹤時間，就能獲得我們願意發布的數據。

Our conviction of the mechanism on this program continues to be strong, and this is simply a matter of escalating a little bit further.

我們仍然堅信該計劃的機制，這只是進一步升級的問題。

And then Salveen, on HS and Povorcitinib, and if Mohamad -- excuse me, Matteo has any comments he can add. First of all, as you know, it's one of the most challenging conditions in in dermatology, ask any dermatologists that IL-17s don't work almost half the time.

然後是Salveen，關於HS和Povorcitinib，如果Mohamad——不好意思，Matteo有什麼意見可以補充。首先，如你所知，這是皮膚科最具挑戰性的疾病之一，問問任何一位皮膚科醫生，IL-17幾乎有一半的時間都不起作用。

One dermatologist described high-score 50 or even 75 as a beauty contest. It's very hard to compare high score rates from one study to the next. The condition, as you know, is fundamentally different than IL-23 mediated psoriasis or IL-4/-13 mediated AD. That is to say it's inflammation suit. There are multiple pathways involved.

一位皮膚科醫生把50分甚至75分的高分描述成選美比賽。很難比較不同研究的高分率。如你所知，這種疾病與IL-23介導的銀屑病或IL-4/-13介導的AD有著根本的不同。也就是說，它是一種發炎反應。它涉及多種途徑。

If you ask a dermatologist, what's most important, they'll first say, make the patient feel better and then make them look better, meaning clearance. And this is a quality-of-life condition. If you look at the data from Povorcitinib and you look at the effect that the drug has on pain and flare control, it's pretty remarkable, and it's a very competitive data set.

如果你問皮膚科甚麼最重要，他們首先會說，讓病人感覺更好，然後讓他們看起來更好，也就是清除病灶。這關係到生活品質。如果你看看Povorcitinib的數據，看看它對疼痛和控制發作的效果，你會發現它非常顯著，而且這是一個非常有競爭力的數據集。

It also does -- you get out past week 12 at week 16 or 18, those clearance rates are in the 50% range. And if you look at the effect of the drug across all those end points, clearance pain, flare control, half the effect is in the first three weeks.

確實如此──如果你過了12週，也就是16週或18週，這些清除率都在50%左右。如果你觀察藥物在所有終點指標（疼痛清除率、控制發作率）的效果，你會發現一半的效果是在前三週產生的。

So I believe that a systemic option like Povorcitinib is going to have a place in the treatment paradigm for HS. Whether they're starting with Povorcitinib and then go into a biologic or they go to a biologic and then to Povorcitinib. I don't think anyone has a clear view on the future, but this is a condition that there's a lack of treatment options we have good data.

所以我相信像Povorcitinib這樣的系統性治療方案將在HS的治療模式中佔有一席之地。無論是先用Povorcitinib，然後再用生物製劑，還是先用生物製劑，然後再用Povorcitinib。我認為沒有人對未來有清晰的認識，但在這種情況下，治療方案的匱乏，我們擁有充足的數據。

And when you look at the totality of the evidence, there's going to be a place for Povorcitinib as well as the IL-17s.

當你查看所有證據時，你會發現 Povorcitinib 和 IL-17 都有其用武之地。

Salim Syed, Mizuho Securities.

瑞穗證券的 Salim Syed。

First, my welcome to Bill. And thanks for the question. I guess maybe one for us on Niktimvo. So you had a good beat again on the quarter. And obviously, the J-code went into effect here around April -- April 1, I believe. Can you maybe comment to some of the intra-quarter dynamics there that you saw from the [JK] going into effect? Or do you describe the strength of the quarter to any other particular part of the launch?

首先，歡迎比爾。謝謝你的提問。我想也許Niktimvo值得我們關心一下。所以你在本季的業績表現又不錯。顯然，J代碼大約在4月——我記得是4月1日——開始生效。你能否評論一下JK代碼生效後你觀察到的一些季度內動態？或者，你能描述一下本季的強勁表現與產品發布過程中其他特定環節的對比嗎？

And I don't think you guys mentioned the inventory impact there for the quarter. So maybe just remind us what the inventory impact was for the quarter.

我覺得你們沒有提到本季庫存的影響。所以，或許可以提醒一下我們本季庫存的影響是什麼。

Yeah. Thanks for the question. I'll give you my overall assessment and either Mohamed or Christiana can fill in some of the details. As Christiana said, we're five months in, and we're at a 10% penetration of that third, fourth line market. And what we watch on a weekly basis and which is important for any new product launch is what do your new patient starts look like.

是的，謝謝你的提問。我會給你我的整體評估，Mohamed 或 Christiana 可以補充一些細節。正如 Christiana 所說，我們已經投入了五個月，在三、四線市場的滲透率達到了 10%。我們每週都會關注的，對於任何新產品的發布都很重要，那就是你的新患者狀況如何。

Every pharmaceutical products like a leaky bucket and you have to maintain -- the same is true with Opzelura. You have to maintain new patient starts. So when I look at the dynamics underneath Niktimvo, that's what I'm focused on. This product over the next five, six, seven months, say, the balance of the year has the potential to reach over 1,000 patients. That would be a very, very good first year.

所有藥品都像漏水的桶，你必須維持——Opzelura 也是如此。你必須維持新患者的開始。所以，當我觀察 Niktimvo 的動態時，我關注的就是這一點。這款產品在未來五、六、七個月，也就是今年剩下的時間裡，有潛力覆蓋超過 1,000 名患者。那將會是一個非常非常好的第一年。

If you take a look at the adoption curve, for example, of Sanofi's REZUROCK and you look at the adoption curve right now for Niktimvo, they're both in the same ZIP code. Now, new product launches are very unpredictable. They can be fickle and there can be a lot of choppiness from quarter to quarter. But I like the momentum, the underlying momentum of the business right now. As you heard, over 80% of BMT centers in the United States are using Niktimvo.

例如，如果你看一下賽諾菲REZUROCK的採用曲線，再看看Niktimvo目前的採用曲線，你會發現它們都位於同一個郵遞區號區。現在，新產品的發布非常難以預測。它們可能變化無常，每個季度之間可能會有很大波動。但我喜歡目前業務的勢頭，潛在的發展勢頭。正如你所聽到的，美國超過80%的BMT中心都在使用Niktimvo。

That's also important because you need a large group of users, prescribers, or in this case, accounts. The other thing that is reassuring to me is we have 4,500 infusions and roughly 700 patients. Which means the large majority of patients, my estimate could be 90% of patients are still on product. And so with a -- when you have a chronic disease like this, duration of therapy isn't necessarily measured in months. It can be measured much longer than that.

這也很重要，因為你需要大量的使用者、處方人員，或者說，在這個例子中，也就是帳戶。另一件讓我感到安心的事情是，我們有4500次輸液和大約700名患者。這意味著絕大多數患者，我估計可能有90%的患者仍在使用產品。所以，對於像你這樣的慢性疾病來說，治療時間不一定是以月為單位。它可以被測量得更長。

And so I don't think we could have gotten off to a better start. But I'm very paranoid. We're in the middle of the first year of launch. You have to really manage the details very carefully. And of course, the ops designation makes this economically feasible for institutions.

所以我覺得我們開局再好不過了。但我非常謹慎。我們正處於上線第一年的中期。你必須非常謹慎地處理細節。當然，營運部門的指定使得這對機構來說在經濟上可行。

Mohamed, do you want to cover anything that I missed?

穆罕默德，你想補充一下我遺漏的內容嗎？

Yeah, you didn't miss much. But I think here, Salim, it's just really important to just underscore that we're pleased with the performance so far. You heard earlier about 10% penetration in that third-line plus setting. Also important to note that there's about 3,500 patients that are in play at any given time in the third-line plus setting.

是的，你沒錯過太多。但我認為，Salim，在這裡，我們非常有必要強調一下，我們對目前的表現感到滿意。你之前聽說，三線以上治療方案的滲透率約為10%。同樣值得注意的是，在三線及以上治療方案中，任何時候都有大約3500名患者接受治療。

That means these are the patients that are up for grabs that are changing therapy and some capacity. So we're either at 10% of the third-line plus setting in total, over 20% of that in-play opportunity, which, again, is a testament of commercial execution.

這意味著這些患者正在改變治療方案，並影響部分治療容量。因此，我們要麼佔了三線及二線治療的10%，要麼佔了超過20%的在賽治療機會，這再次證明了我們商業化的執行力。

You heard some of the metrics around infusions and penetration from Bill. I think the last thing maybe I'd say is that we know prescribers are seeing real-world results, very similar to what they saw in our clinical trials, which is not always the case in this disease, and this is going to naturally encourage providers not only to use Niktimvo more often, but perhaps also consider Niktimvo earlier in their treatment paradigm for more patients.

您剛剛聽到了比爾提到的一些關於輸注和滲透的指標。我想最後要說的是，我們知道處方醫生看到了現實世界的結果，這與他們在臨床試驗中看到的結果非常相似，而這種疾病的情況並非總是如此，這自然會鼓勵醫療服務提供者不僅更頻繁地使用尼伐替尼，而且或許還會在治療方案的早期階段考慮將尼伐替尼用於更多患者。

Just on inventory, can you just comment on that?

僅就庫存而言，您能對此發表評論嗎？

Yeah, the inventory. Just to put that in perspective, inventory accounted for less than 5% of Q2 sales so far, and that's stabilizing in that expected range. So the performance that you're seeing and the volume is driven primarily by demand.

是的，庫存。客觀來看，庫存佔第二季銷售額的比例不到5%，目前正穩定在預期範圍內。所以，您看到的表現和銷售主要受需求驅動。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

This is Clare on for Kelly. Thanks for taking our question and congrats on the quarter. So you have the initial G12D and bispecific data presenting at ESMO. Whether you can provide more granularity on the scope of proof-of-concept data? And maybe help us understand what would be the key metrics you're looking for to define success and move the program forward.

我是 Clare，代表 Kelly 發言。感謝您回答我們的問題，並祝賀本季取得的成績。您已經在 ESMO 上展示了 G12D 和雙特異性抗體的初始數據。您能否更詳細地介紹一下概念驗證資料的範圍？或許也能幫助我們了解，您認為哪些關鍵指標能夠定義專案的成功並推動其發展。

Great. Pablo, you want to take that?

太好了。 Pablo，你想拿走它嗎？

Certainly. So what we should expect -- what you should expect for the two presentations at ESMO, in a way, it's consistent with what we did last year with CDK2. As we've made -- we try to be disciplined about presenting data. We want to present substantial data sets to give you clarity on how well this compounds work in terms of both efficacy and safety and to be able to have with you a discussion about next steps for the programs. And that's exactly what you should expect here.

當然。所以，我們對ESMO的兩場報告的預期，在某種程度上，與我們去年在CDK2專案上所做的一致。正如我們所做的那樣，我們力求在數據呈現上保持嚴謹。我們希望提供大量的資料集，讓大家清楚了解這些化合物在療效和安全性方面的表現，並且能夠與大家討論專案的後續進展。這正是你們該期待的。

We're going to have a substantial number of patients for both our KRASG12D program and our TGFßR2xPD-1 bispecific. And we believe that both demonstrate proof of concept in a range of tumor types and the amount of data we'll be able to use that to have a discussion with you on the next steps for these two programs, which we expect to do at ESMO in the next couple of months.

我們的KRASG12D計畫和TGF-R2xPD-1雙特異性抗體都將迎來大量患者。我們相信，這兩個項目都已在多種腫瘤類型中展現出概念驗證，我們將能夠利用這些數據與您討論這兩個項目的後續步驟，預計將在接下來的幾個月內在ESMO年會上進行討論。

Thank you.

謝謝。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Congrats on all the progress and welcome to Bill. Look forward to working with you. Question on Opzelura. I know your guidance was unchanged, but I wanted to unpack the dynamics underlying that. And I'm curious the degree to which pediatric indication is embedded there. And then maybe how we should be thinking about the ex-US cadence going forward? I know you saw a big uptick but international can be a bit lumpy.

恭喜您取得的所有進展，歡迎比爾。期待與您合作。關於Opzelura的問題。我知道您的指導方針沒有改變，但我想探究背後的動態。我很好奇兒科適應症在其中的表現程度。那麼，我們該如何看待未來美國以外地區的發展節奏呢？我知道您看到了大幅成長，但國際市場可能有點不穩定。

And then maybe longer term, the degree to which the moderate AD data from [284] might expand the market opportunity down the road?

那麼從長遠來看，[284] 中的適度 AD 數據可能會在多大程度上擴大未來的市場機會？

Yeah, Brian, good question. I'll give you my initial observations after the first 30 days. Obviously, 60% of the business is AD and 40% is vitiligo, right? That AD business is growing at plus 20% and the vitiligo business is growing at plus 10%. Our penetration of this market, if you just think about the AD market as systemic and topicals, is still relatively modest, 7% of the overall AD market systemic, and about 17% of the topical market, right?

是的，布萊恩，這個問題問得好。我會告訴你我最初30天後的初步觀察。顯然，60%的業務是AD，40%是白斑，對吧？ AD業務的成長速度是20%，白斑症業務的成長速度是10%。如果你把AD市場分成全身用藥和局部用藥，我們在這個市場的滲透率仍然相對較低，全身用藥佔整個AD市場的7%，局部用藥佔17%左右，對吧？

Market's grown at 20% year over year because of migration from topical corticosteroids to a nonsteroidal option, topical or systemic. And that TCS market in the United States at branded pricing is about $15 billion. right? Now it's moving at a modest rate, but that's what's fueling the growth of the market that they're in. And as I said, I see it as a -- I see this as a double-digit CAGR business both US. And of course, internationally over the next several years, just with AD and with vitiligo.

由於從外用皮質類固醇轉向非類固醇類藥物（無論是外用或全身性用），市場較去年同期成長20%。美國TCS市場（品牌藥）的規模約為150億美元，對吧？目前，它的發展速度適中，但這正是推動其所在市場成長的動力。正如我所說，我認為——我認為美國市場和全球市場在未來幾年的複合年增長率都將達到兩位數。當然，僅就阿茲海默症和白斑而言，也是如此。

As it relates to pediatric, I would think about it as an incremental growth driver, all right? Here's what we know. There's about $2 billion in triamcinolone use at branded pricing in the United States. But I think we have to be realistic about the extent to which we're going to drive utilization in pediatrics. I think the core business right now is what's going to drive growth over the next several years.

就兒科而言，我認為它是一個增量成長動力，對吧？以下是我們所知道的。在美國，曲安奈德的品牌藥價格約為20億美元。但我認為我們必須現實地看待我們在兒科推動該藥物使用率的程度。我認為目前的核心業務才是未來幾年推動成長的關鍵。

The product's got 20,000 users in the United States, prescribers, which is second to only DUPIXENT in AD. And so there's a large prescriber base hearing when you're thinking about the long-term growth potential of any product, that's important.

該產品在美國擁有2萬名處方用戶，在AD領域僅次於DUPIXENT。因此，當你考慮任何產品的長期成長潛力時，擁有龐大的處方使用者群體至關重要。

And then as you know, the coverage both commercial, Medicaid and Medicare is solid. It's not cheap, but it's solid coverage. And so I like the way it looks. As it relates to the international business, I just spoke with the person who runs our international business the other day about this.

而且如你所知，商業保險、醫療補助（Medicaid）和醫療保險（Medicare）的保障範圍都很廣。雖然不便宜，但覆蓋範圍很廣。所以我喜歡現在的樣子。至於國際業務，我前幾天剛和我們國際業務的負責人談過這件事。

France, Italy, Germany, and Canada, right? We had a good first or second year. It's gone from $60 million to roughly $120 million in sales. We'll get the AD -- that was just in vitiligo. And the indication for AD has the potential to keep that business growing and maybe you to exit over several years?

法國、義大利、德國和加拿大，對吧？我們第一年或第二年表現不錯。銷售額從6000萬美元成長到大約1.2億美元。我們會獲得AD——那隻是針對白斑的。 AD的適應症有潛力維持業務成長，也許你會在幾年後退出？

Pablo, anything you want to add?

帕布羅，您還有什麼要補充的嗎？

No, you covered it all. And on the ped side, we see the same way. It's a great tailwind to sustain the growth of our already strong value proposition in that disease.

不，您已經涵蓋了所有內容。在兒科方面，我們也持同樣的看法。這對於維持我們在該疾病領域本已強大的價值主張的成長，無疑是一個巨大的助力。

Great. Thanks, Brian.

太好了！謝謝，布萊恩。

Thank you.

謝謝。

Jessica Fye, JPMorgan.

潔西卡費伊（Jessica Fye），摩根大通。

Thanks for taking my questions. A couple more for Bill. Curious how you plan to balance investment in pipeline advancement relative to external opportunities, relative to the need for investment to support kind of near-term commercial performance. And I guess, if we think about kind of looking out five years from now, how do you see Incyte? Is this going to be mainly organically grown, transformed through M&A, some kind of combination?

感謝您回答我的問題。還有幾個問題想問比爾。我很好奇，您計劃如何平衡研發管線的投入、外部機會以及支持短期商業表現所需的投資。如果我們展望五年後，您如何看待Incyte？ Incyte會以有機成長為主，還是透過併購轉型，還是某種形式的整合？

Yeah, it's a really good question. I think there's a lot in that. Look, the job here, it's not just mine, it's Pablo and Steven and Christiana and the people who run the Commercial business, it's about, forgive the baseball metaphor, it's about calling balls and strikes. And you have to look at internal investments and external investments the exact same way. There are no sacred cows inside the company.

是的，這個問題問得真好。我覺得這裡面有很多東西。你看，這份工作，不只是我的，還有Pablo、Steven、Christiana以及所有負責商業部門的人，這關乎——請原諒我用棒球來打比方——判斷好壞。你必須以同樣的方式看待內部投資和外部投資。公司內部沒有不可侵犯的神聖不可侵犯的事物。

It's also not true that everything outside the company is a shiny penny. And I've been here 30 days, but I will tell you all we think about is capital allocation, both internally and externally.

也並非公司外部的一切都光鮮亮麗。我來這裡才30天，但我要告訴你，我們考慮的只是資本配置，包括內部和外部。

In terms of the balance between the two, I don't like to force any ratio. I think we have to just look at facts, details, and analysis and make our calls. As it relates to where I want to see the company in five years, it'd be nice to exit. But I think what we want to do is to -- and I mentioned this earlier, set a new high watermark for this company. I mean we have to get through 2029.

至於兩者之間的平衡，我不喜歡強行設定任何比例。我認為我們必須根據事實、細節和分析做出判斷。考慮到我對公司五年後的預期，退出固然是好事。但我認為我們想做的是——我之前提到過——為公司創下新的高點。我的意思是，我們必須撐到2029年。

But set new highs for the company, and that means getting our growth portfolio right, and I include that Opzelura and Niktimvo, and then '989 in Povo. And I know there's no guarantee there. We have to manage those programs.

但要為公司創下新高，這意味著我們要正確規劃我們的成長投資組合，其中包括Opzelura和Niktimvo，以及Povo的989。我知道這並非板上釘釘的事。我們必須管理好這些項目。

Next, get R&D priorities right, which is what every company has to do, then get the cost base right. That's just good corporate hygiene. Get BD right, and build the business for the long term so that we really never see the end of the road. And as I mentioned earlier, I do believe we have a win of opportunity in MPNs where we have differentiated knowledge and capabilities to build a really great business there.

接下來，確定正確的研發重點，這是每家公司都必須做的，然後確定正確的成本基礎。這只是良好的企業衛生習慣。正確制定業務發展計劃，並專注於長期發展，這樣我們才能真正走下去。正如我之前提到的，我相信我們在MPN領域擁有巨大的機遇，我們擁有差異化的知識和能力，可以在該領域打造真正卓越的業務。

Thanks for the question.

謝謝你的提問。

Marc Frahm, TD Cowen.

馬克·弗拉姆（Marc Frahm），TD Cowen。

Thanks for taking my questions. Maybe one quick one, clarifying in an earlier answer. Just on the threshold in MF for mutant CALR. Even if maybe the best path forward is combinations, do you need to see kind of convincing monotherapy activity that if that was all you had would have justified moving forward as well in order to kind of move the program forward either as the monotherapy or is the combo? Or it's just convincing combo data enough?

感謝您回答我的問題。也許我快速問一個問題，澄清一下之前的一個回答。突變 CALR 的 MF 門檻就在這裡。即使聯合療法可能是最好的前進方向，您是否需要看到令人信服的單藥治療數據，如果僅憑這一點，是否也應該繼續推進，才能推動計畫進展？無論是單藥治療還是合併療法？或者，只要有令人信服的聯合療法數據就足夠了？

And then similar to that, maybe Bill, when you're talking through the kind of the way to think about prioritizing financial resources, you can put solid tumor oncology or oncology (inaudible) as maybe the third priority.

然後與此類似，也許比爾，當你談論如何優先考慮財政資源時，你可以把實體腫瘤腫瘤學或腫瘤學（聽不清楚）作為第三優先事項。

When you think about the G12D data coming, you guys are not first-in-class there necessarily. And the next steps are likely some combinations in addition to monotherapy work where this program really starts to blossom. Does it need to be a convincing best-in-class agent in order to justify that investment? Or is kind of over time competing in various combinations, but with a more similar asset enough to justify investment?

考慮到即將發布的G12D數據，你們並不一定在同類產品中處於領先地位。下一步，除了單藥治療之外，可能還會進行一些聯合療法研究，屆時這個計畫才能真正開始蓬勃發展。它是否需要成為令人信服的同類最佳藥物才能證明這項投資的合理性？或者，隨著時間的推移，在各種組合中進行競爭，但擁有更相似的藥物，是否足以證明投資的合理性？

Good. Marc, thanks for the question. I'll turn over the first question to Pablo and then probably Pablo and I will take the second question together. Go ahead, Pablo.

很好。馬克，謝謝你的提問。我先把第一個問題交給帕布羅，然後我和帕布羅可能會一起回答第二個問題。請講，帕布羅。

So let me address the '989. And the short answer, Marc, is we absolutely have to have single-agent activity in MF. I think it's an expectation based on the mechanism of action of '989 that it will have single-agent activity in patients with myelofibrosis.

那麼，讓我來談談'989。 Marc，簡而言之，我們絕對需要單藥治療骨髓纖維化（MF）。我認為，基於'989的作用機制，我們期望它能夠單藥治療骨髓纖維化患者。

The question here is as we build a comprehensive plan to basically cover the needs of every single patient with a [myelopyripheral] neoplasm, we want to make sure we can address early MF, first-line MF, and patients with MF that failed on Jakafi, either for intolerance or progression on Jakafi.

這裡的問題是，當我們制定一個全面的計劃來基本上滿足每一位患有 [髓葉] 腫瘤的患者的需求時，我們希望確保我們能夠解決早期 MF、一線 MF 以及因不耐受或因 Jakafi 進展而對 Jakafi 治療失敗的 MF 患者。

And to do that, we need a comprehensive data set to show you a single agent and combination data with Jakafi. But it's an expectation based on the mechanism of action '989 that it will have single-agent activity in myelofibrosis.

為此，我們需要一個全面的數據集來向您展示Jakafi的單藥和聯合用藥數據。但基於其作用機制，我們預期它對骨髓纖維化具有單藥治療活性。

Great, thanks, Pablo. And as it relates to G12D and Pablo will also comment -- first thing I said is we're very clear eyed about this. There are dozens in development. And in hands of big companies, the hurdle here is high, and we'll be clear eyed about making a decision. If you're not first, you'd better be early and most importantly, the position has to be defensible, right?

太好了，謝謝，Pablo。至於G12D，Pablo也會評論——首先我想說的是，我們對此非常清楚。目前有幾十個項目正在開發中。如果交由大公司開發，門檻會很高，我們會保持清醒的頭腦做出決定。如果你不是第一個，最好儘早行動，最重要的是，這個位置必須穩固，對吧？

And when we get that data, we're going to have to make that decision. We do believe that the properties of G12D could be differentiating, and we believe that it will have a place in the treatment paradigm. And I'll let Pablo talk a little bit about that.

當我們獲得這些數據時，我們必須做出決定。我們確實相信G12D的特性可能具有差異性，並且我們相信它將在治療模式中佔有一席之地。我讓Pablo稍微談談這件事。

So to complement what Bill said, this is, as you know, Marc, a very competitive space, G12D and there's some excellent programs advancing in this setting. Well, we think we have our G12D program, and we look forward to showing the data so we can discuss this in more detail we did in hand.

所以，補充一下比爾所說的，馬克，正如你所知，G12D 是一個競爭非常激烈的領域，而且在這個領域有一些優秀的項目正在推進。嗯，我們認為我們已經有 G12D 專案了，我們期待展示相關數據，以便我們能夠更詳細地討論我們手邊正在做的事情。

It's (inaudible) not only might be competitive in terms of single-agent activity, but a combined ability might be better than some of our competitors. And when you think about the really, really big opportunity here, which is first-line pancreatic cancer, that's going to require more likely than auto combination therapy with intensive chemotherapy.

它（聽不清楚）不僅在單藥治療方面可能具有競爭力，而且綜合療效也可能比我們的一些競爭對手更好。想想這裡真正巨大的機會，也就是胰臟癌的第一線治療，這比單純的聯合療法和強化化療更有可能實現。

In that context, we think we have a path to compete with some of the other programs. So as Bill said, we may not be first-in-class, but we're certainly in the front of the pack when it comes to positioning. And if the combined ability of our G12D inhibitor is better than some of our competitors, perhaps there is a way to accelerate development in early lines of therapy in pancreatic cancer. That's the way we're seeing the program.

在此背景下，我們認為我們有辦法與其他一些項目競爭。正如比爾所說，我們或許並非同類產品中的佼佼者，但在市場定位方面，我們無疑處於領先地位。如果我們的G12D抑制劑的綜合療效優於一些競爭對手，或許可以加速胰臟癌早期療法的研發。這就是我們對這個項目的看法。

As Bill said in his introductory remarks, we will have a very high bar to continue to advance this program forward once we share all the data, and we'll make those decisions later this year.

正如比爾在開場白中所說，一旦我們共享所有數據，我們將對繼續推進該計劃設定非常高的標準，我們將在今年晚些時候做出這些決定。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

This is Connor McKay on for Evan. Thanks for taking our question and congrats on the quarter. This is the second quarter in a row that Niktimvo has come in ahead of consensus expectations. And you shared a little bit today about kind of the dynamics in the early days of the launch. But I'm curious, maybe can you remind us how you're thinking about sort of the peak opportunity for this product? And kind of has the launch trajectory in the early days change that at all?

我是 Connor McKay，Evan 的節目主持人。感謝您回答我們的問題，並祝賀本季的佳績。這是 Niktimvo 連續第二季業績超出市場預期。您今天分享了一些產品發布初期的動態。我很好奇，能否請您分享一下您是如何看待這款產品的巔峰機會的？早期的發布軌跡是否改變了這種局面？

And then I guess maybe just one quick follow up for Bill as well. We discussed a little bit about business development and how you're prioritizing that versus the internal pipeline. I guess are there any therapeutic areas that you'd be most focused on sort of as it relates to business development.

然後我想也許還有一點跟進比爾的問題。我們稍微討論了一下業務發展，以及您如何優先考慮業務發展和內部研發管線。請問您最關注的治療領域有哪些，與業務發展有關？

Great. I'll take a shot first at the first question and then let Mohamed fill in, and then I'll come back to the second question. As it relates to the peak potential of Niktimvo, it's really hard to figure out what's going to happen in five years. I'm pretty modest about the accuracy of my future predictions.

太好了。我先回答第一個問題，然後請穆罕默德補充，之後我再回答第二個問題。由於關係到Niktimvo的巔峰潛力，很難預測五年後會發生什麼。我對未來預測的準確性非常謹慎。

But I will tell you that it's only two quarters, and I've been on both sides of this, positive and negative. I'm reassured by what I see. I think the potential of this product in part is going to trade on can we get it into combination with Jakafi and with steroids. And those studies are ongoing. That's number one.

但我得說，這才兩個季度，我對此既有正面的，也有負面的。我對我所看到的情況感到安心。我認為這款產品的潛力部分取決於我們是否可以將其與Jakafi以及類固醇藥物合併使用。這些研究仍在進行中。這是第一點。

We also have a team working on a subcu formulation, which I think is very important. And that's going to get you into frontline, whether you're a monotherapy or whether you're a combination therapy.

我們還有一個團隊在研究皮下注射劑型，我認為這非常重要。無論你是單一療法還是聯合療法，這都能讓你進入第一線治療。

Now we have to take care of the short term and build a real solid business in the indication that we have today, and all estimates are that we're doing that. Things can sort of wobble around quarter to quarter. But since your question was about the long term, my expectations are, when you look at a product like REZUROCK at Sanofi, that could be the low watermark for us. And I think if you get these additional indications, then you're going to travel north of that.

現在我們必須著眼短期，在現有適應症的基礎上建立真正穩固的業務，所有預測都表明我們正在這樣做。情況可能會在每個季度之間出現波動。但既然你的問題是關於長期的，我的預期是，當你看到賽諾菲的REZUROCK這樣的產品時，這可能是我們的低谷。我認為，如果你獲得這些額外的適應症，那麼你的表現將會更高。

Mohamed?

穆罕默德？

Yeah. Maybe just to quickly complement there. I think, look, in the first five months, we mentioned we've been able to capture 20% of that in-place segment. If by the end of the year, we can capture it to Bill's point earlier, 1,000 patients, so let's call it, 30% of that in-play market. We'd be ahead of GVHD analog and overcome any entry of order of entry discounts.

是的。也許只是為了快速補充。我想，在前五個月，我們提到我們已經能夠佔據20%的現場治療市場。如果到今年年底，我們能夠像比爾之前提到的那樣，達到1000名患者，那麼我們就可以說，佔據30%的現場治療市場份額。我們將領先GVHD類似物，並克服任何進入順序折扣的影響。

So if you consider those same analogs then, I think it will be conceivable for just our indication that we have today to deliver several hundred million dollars of annual sales by 2028. So we're currently working ahead and performing ahead of analogs in the space. And I think we're performing to an extent where we're going to mute, I think, order of entry analog to a certain extent, and I think you can put projections based on some of the analogs.

所以，如果考慮這些類似的公司，我認為，僅憑我們今天提出的目標，到2028年實現數億美元的年銷售額是可以想像的。因此，我們目前在該領域的努力和表現都領先於其他類似公司。我認為，我們的表現已經達到了一定程度，可以在一定程度上壓制其他類似公司的進入順序，而且我認為你可以根據一些類似公司做出預測。

Yeah. And as it relates to the second question, if you study companies that have great businesses, there are a couple of criteria that are common in terms of new therapeutic areas. And I'll just say upfront, we've never gone to a new therapeutic area that would stretch our capabilities, or we would go beyond our competencies.

是的。關於第二個問題，如果你研究那些業務優秀的公司，你會發現在新治療領域，有幾個共同的標準。我先說一下，我們從未涉足任何會拓展我們能力或超出我們能力範圍的新治療領域。

Because I do believe right now, we're in two excellent areas with excellent prospects for growth. But you look -- first of all, chronic disease management is -- has a lot of sort of attributes to it. You look for a fairly sizable population, unmet need, the potential to have a standard of care approach and where duration of therapy is measured in years, not months.

因為我確實相信，目前我們正處於兩個非常優秀的領域，擁有極佳的成長前景。但首先，慢性病管理有許多特點。它需要相當龐大的人口、尚未滿足的需求、實現標準化護理方案的潛力，以及治療時長以年而非月來衡量。

And there are some logical extensions of our current business in hem/onc and immune-mediated skin conditions or I&I. And we'll continue to look at it. But my focus right now is on what we have. And if there's an opportunity to enter another therapeutic area that makes sense strategically operation financially. We'll explain it and do it, but the focus right now is what's inside the company.

我們目前在血液/腫瘤和免疫介導皮膚病（I&I）領域的業務有一些合理的延伸。我們會繼續關注。但我現在的重點是我們現有的業務。如果有機會進入另一個在策略營運和財務上都合理的治療領域，我們會解釋並實施，但現在的重點是公司內部的情況。

Kripa Devarakonda, Truist Securities.

Kripa Devarakonda，Truist 證券公司。

Thank you so much for taking my question. And Bill, let me extend my welcome, looking forward to working with you. I have a question on Jakafi in PV. You saw continued growth in PV. It continues to be -- Jakafi continues to be a key growth driver here. Can you talk about the patient population where you're seeing increased uptake?

非常感謝您回答我的問題。比爾，請允許我向您表示歡迎，並期待與您合作。我有一個關於Jakafi在真性長效化療（PV）中應用的問題。您看到PV的療效持續成長，Jakafi仍然是該領域的關鍵成長動力。您能談談哪些患者群的療效有提升嗎？

And also given the footprint you have established here, any thoughts on life cycle management beyond XR and V617F, which we're going to see data, hopefully next year, would be helpful. And also one follow-up question. Monjuvi, was approved for relapsed/refractory FL in June. Just any thoughts on expectations there for the remainder of the year?

另外，鑑於您在這裡建立的足跡，除了XR和V617F（我們希望明年能看到數據）之外，您對生命週期管理的任何想法都會很有幫助。還有一個後續問題。 Monjuvi於6月獲得核准用於治療復發/難治性濾泡性淋巴瘤。您對今年剩餘時間的預期有什麼看法？

Yeah, thanks for the question. I'll just go ahead and turn it over to Mohamed to address the question on Jakafi.

是的，謝謝你的提問。接下來，我將把時間交給Mohamed，讓他回答關於Jakafi的問題。

Yeah, Maybe let me take a stab on Jakafi, Monjuvi. Then Bill, I'll give it back to you for any added remarks. Look, PV is the least penetrated indication for Jakafi when compared to the other two indications, thus being our biggest growth driver. Our team is doing a very effective job in educating the market on the importance of treating PV earlier with Jakafi and its benefits of thrombosis-free survival.

是的，或許我可以試試Jakafi和Monjuvi。然後Bill，如果有任何補充意見，我會回覆你。你看，與Jakafi的其他兩個適應症相比，真性血小板減少症（PV）是Jakafi滲透率最低的適應症，因此也是我們最大的成長動力。我們的團隊正在非常有效地向市場宣傳使用Jakafi早期治療PV的重要性及其無血栓存活期的益處。

As a result, you continue to see strong double-digit growth in Q2, and we're confident in that momentum going forward. So there, the patient population is simply patients on an earlier-line therapy that are experiencing symptoms and/or need an intervention. And when using Jakafi for those patients, they benefit from thrombosis-free survival. If I can just quickly touch on Monjuvi, and then Bill, I'll give it back to you.

因此，我們在第二季度繼續保持強勁的兩位數成長，並且我們對這一勢頭充滿信心。因此，患者群體僅限於接受早期治療、出現症狀和/或需要介入的患者。這些患者使用Jakafi後，可受惠於無血栓存活。我可以簡單介紹Monjuvi，然後比爾，我會把時間交還給您。

Look, I think it's important to note Monjuvi showed a 59% risk reduction, disease progression or death, versus what is currently the standard of care. So we believe, naturally, Monjuvi has the potential to be the new standard of care for patients living with FL.

值得一提的是，與目前的標準治療相比，Monjuvi 顯示出將疾病進展或死亡風險降低了 59%。因此，我們相信，Monjuvi 有潛力成為濾泡性淋巴瘤 (FL) 患者的全新治療標準。

And we expect the growth ramp though here to be reflective of the indolent nature of the disease, and our expectations for the balance of the year are captured in the guidance that Christiana provided for the other hem/onc portfolio, with really good execution Monjuvi and FL alone, excluding any other indication can be one of those incremental growth drivers and deliver $200 million or so in annual revenue by 2028.

我們預計這裡的成長坡度將反映出這種疾病的惰性，我們對今年剩餘時間的預期體現在 Christiana 為其他血液/腫瘤產品組合提供的指導中，如果 Monjuvi 和 FL 執行得非常好，排除任何其他跡象，就可以成為那些增量增長動力之一，到 2028 年實現每年 2 億美元左右的收入。

Yeah, I think Mohamed said it well, very focused on the growth of Jakafi over the next several years. Obviously, our penetration in MF is high. And as Mohamed said, in GVHD, I would describe it as medium. And then in PV, it's low, which is why you're seeing double-digit growth with that product right now or with that indication right now, I think we'll continue to see that. And the MAJIC-PV study is only a couple of years old. So thanks for the question.

是的，我認為Mohamed說得很好，他非常關注Jakafi未來幾年的成長。顯然，我們在MF（骨髓纖維化）方面的滲透率很高。正如Mohamed所說，在GVHD（移植物抗宿主疾病）方面，我認為滲透率處於中等水平。在PV（真皮生長因子受體激動劑）方面，滲透率較低，這就是為什麼你現在看到該產品或該適應症出現兩位數增長的原因，我認為這種情況還會持續下去。 MAJIC-PV研究也只是幾年前進行的。謝謝你的提問。

Thank you.

謝謝。

Stephen Willey, Stifel.

史蒂芬威利（Stephen Willey），Stifel。

Thanks for taking the questions. Just a couple on '989. Can you say anything about the characteristics of the MF patients enrolled into the Phase 1 with respect to just baseline cytopenias hemoglobin. Were there any restrictions placed on eligibility criteria? Or should we expect that this is going to look like a typical JAK experience patient population?

感謝您回答問題。關於'989，我只想問幾個問題。您能否談談入選 I 期臨床試驗的 MF 患者在基線血球減少和血紅素方面的特徵？入選標準有什麼限制嗎？或者我們應該預期這看起來像一個典型的 JAK 患者群體？

And then just wondering how we should also be thinking about the duration of follow up we'll have relative to what was just presented in ET.

然後我只是想知道我們應該如何考慮相對於 ET 中剛剛提出的內容的後續持續時間。

Thanks for the question. Pablo will take it.

謝謝你的提問。 Pablo 會回答。

So the population is as you call the typical of patients have been exposed to Jakafi. There are patients that are intolerant or progressed. So it's a pretty representative population in MF. We were not very restrictive in terms of enrollment criteria. So I think it will be very informative in order to discuss next steps for '989 in patients with MF.

所以，正如你所說，該族群是接受過Jakafi治療的典型患者。其中有些患者不耐受或病情進展。所以，這在MF患者中是相當有代表性的族群。我們的入組標準並沒有非常嚴格。因此，我認為這對於討論989方案在MF患者中的後續發展將非常有幫助。

Follow up is going to be variable. This has been a dose escalation study, as you know. So the early dose cohorts will have longer follow up than the later dose, higher dose cohorts. But all in all, we'll have patients with pretty substantial follow up because the study is (inaudible) patients at low doses more than a year ago. So we'll have a fair amount of follow up.

後續追蹤會有所不同。如你所知，這是一項劑量遞增研究。因此，早期劑量組的追蹤時間會比後期劑量組（高劑量組）更長。但總的來說，我們將對患者進行相當多的隨訪，因為這項研究（聽不清楚）是一年多前接受低劑量治療的患者。所以我們將進行相當多的追蹤。

Thanks for the question.

謝謝你的提問。

David Lebowitz, Citi.

花旗銀行的 David Lebowitz。

Thanks for taking my question and Bill, welcome to the team. I guess on Jakafi in the current quarter, what were the particular drivers -- which side of the -- which indication drove the (inaudible) therapy the most? I'm curious as to what IRA and the out-of-pocket changes might have had an impact in the quarter and how we should see that impacting going forward?

感謝您回答我的問題，比爾，歡迎加入我們的團隊。我想問一下，就本季的Jakafi而言，具體的驅動因素是什麼？哪種適應症對這種療法的推動作用最大？我很好奇，IRA和自付費用的變化可能對本季產生什麼影響，以及我們應該如何看待這種變化對未來的影響？

Yeah, good question. I'll give you some initial comments and then Mohamed take over. I think the most important point about the quarter is that there was growth in all three indications. And I think you can -- I would view MF and GVHD as mid-single-digit grower -- growing indications.

是的，問得好。我先給你一些初步意見，然後由Mohamed繼續發言。我認為本季最重要的一點是所有三個適應症都實現了成長。我認為MF和GVHD的成長率在中等個位數左右。

And I think this is true over the longer term and PV as a double-digit growing indication. We saw that last quarter. We saw it again this quarter.

我認為從長期來看確實如此，光伏（PV）也預示著兩位數的成長。上個季度我們就看到了這一點。本季我們再次看到了這一點。

And I think given where the product sits in each one of those markets or those indications, that's what the growth profile or the mix is going to look like for the next three-plus years.

我認為，考慮到產品在每個市場中的位置或這些跡象，未來三年以上的成長或組合將會是這樣的。

And then as it relates to the IRA, Mohamed?

那麼這與愛爾蘭共和軍有關嗎，穆罕默德？

Yeah, nothing to add on the growth drivers. On IRA, the simple answer is that it had no impact on our performance in Q2. As you remember, the IRA dynamics had a favorable GTN impact in Q1, but that was a one-time effect as we communicated there. And in Q2, the demand really drove the growth, and that's where you see the performance for Jakafi in the quarter.

是的，關於成長動力沒什麼好補充的。關於IRA，簡單的答案是它對我們第二季的業績沒有影響。您還記得，IRA的動態在第一季對GTN產生了有利的影響，但正如我們當時溝通的那樣，這只是一次性的影響。在第二季度，需求才是真正推動成長的動力，這也是Jakafi在本季的業績表現。

Michael Schmidt, Guggenheim.

古根漢美術館的麥可·施密特。

I just had another bigger picture question for Bill. So in terms of capital allocation and sort of reading between the lines and your prior comments, it sounds like there may be opportunity to perhaps optimize the earlier stage R&D portfolio.

我只是想問比爾一個更宏觀的問題。所以，就資本配置而言，結合你先前的評論，聽起來可能有機會優化早期研發組合。

So longer term, as you think about potentially increasing R&D productivity for the company, are there specific areas where you think Incyte is underinvested, be it in terms of targets, modalities, or disease areas within the broader framework of oncology and I&I?

因此，從長遠來看，當您考慮提高公司的研發生產力時，您是否認為 Incyte 在特定領域投資不足，無論是在腫瘤學和 I&I 等更廣泛框架內的目標、方式還是疾病領域？

And then just a quick one for Pablo on Povorcitinib. Just -- could you just help us understand the importance of the upcoming Phase 2 data in asthma in the second half of the year. I know you've noted in the past that the bar is high to advancing this, but I'm just curious what we should expect there.

然後，我想快速問Pablo關於Povorcitinib的問題。您能否幫助我們理解即將於下半年發布的氣喘二期臨床試驗數據的重要性？我知道您之前提到過，推進這項研究的門檻很高，但我只是好奇我們應該對此抱持怎樣的期待。

Yeah, Michael, good question. Listen, Pablo and I speak a lot about the first question that you just asked regarding specific areas, putting external opportunities aside. As soon as I make a comment about an area, the prices of all those companies would go up. But why don't you just talk about how we're thinking about internal R&D and oncology.

是的，邁克爾，這個問題問得好。聽著，帕布羅和我經常討論你剛才問的第一個問題，關於具體領域，撇開外部機會不談。只要我對某個領域發表評論，所有這些公司的價格就會上漲。但為什麼不直接談談我們對內部研發和腫瘤學的看法呢？

So if I understand your question, Michael, it's more specifically related to the early preclinical pipeline. And what we've been doing there, a lot of which is honestly not visible because we don't disclose pre-IND programs. But we have, over the past couple of years, increasingly tightened our focus around novel biology and applying novel platforms to novel biology.

邁克爾，如果我理解你的問題，這更具體地與早期臨床前研發管線相關。我們一直在做的很多事情，說實話，我們並不公開，因為我們沒有透露IND前的專案。但在過去幾年裡，我們越來越專注於新型生物學，並將新型態平台應用於新型生物學。

So our goal over time is to truly focus on try to be first-in-class applied novel platforms. And that was the impetus behind the collaboration we established with Genesis to take advantage of the capabilities in AI and machine learning drug discovery.

因此，我們的目標是真正專注於打造一流的應用創新平台。這正是我們與Genesis建立合作的動力，旨在利用其在人工智慧和機器學習藥物研發方面的優勢。

The collaboration that we put -- we expanded with Biotheryx to give access to a molecule (inaudible) library. And we will continue to do those because we believe, fundamentally, in order to win in the next 10 years, we need to focus on novel areas, novel targets by applying novel platform. So that's a lot of the emphasis when it comes to the preclinical pipeline.

我們與Biotheryx的合作得到了擴展，以便我們能夠訪問分子庫。我們將繼續合作，因為我們相信，從根本上來說，為了在未來10年取得成功，我們需要應用新的平台，專注於新的領域和新的目標。因此，在臨床前研發管線方面，我們重點強調了這一點。

There was a question on asthma. So -- this remains a really important potential indication for Povo. We think there's the type of patients, particularly those with non-type 2 asthma where there remains a need to reduce exacerbations and deliver substantial improvements in FEV1. And I'm talking about over 100 to 150 mLs.

之前有一個關於氣喘的問題。所以，這仍然是 Povo 的一個非常重要的潛在適應症。我們認為，這類患者，尤其是非 2 型氣喘患者，仍需要減少氣喘發作，並顯著改善 FEV1。我指的是 100 到 150 毫升以上。

So we are really excited about having this data later this year. It's been a program that has not received a lot of attention. So we look forward to deliver results before the end of the year. And depending on those results, obviously discuss next steps.

所以我們非常期待今年稍後能拿到這些數據。這個項目一直以來都沒有得到太多關注。我們期待在年底前拿出成果。當然，我們會根據這些成果討論下一步的行動。

Gavin Clark-Gartner, Evercore ISI.

Gavin Clark-Gartner，Evercore ISI。

Very quick one. For should we expect updated ET data alongside the MF data later this year?

問得很快。那麼，我們是否應該在今年稍後期待更新的ET數據和MF數據一起發布呢？

Yeah, Kevin, it will be an update on ET data as well later this year, absolutely. We are -- as I mentioned in my remarks, we're moving as quickly as we can in ET. We will obtain later this year regulatory feedback with the goal of starting pivotal trials early 2026. So we will provide an update on the ET data that we'll present at EHA later this year.

是的，凱文，今年稍後也會更新胚胎移植（ET）數據，絕對會。正如我在發言中提到的，我們正在盡快進行胚胎移植（ET）研究。我們將在今年稍後獲得監管部門的回饋，目標是在2026年初啟動關鍵性試驗。因此，我們將在今年稍後的歐洲胚胎移植（EHA）大會上更新胚胎移植（ET）數據，並提交給歐洲胚胎移植（EHA）大會。

Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over for any further closing comments.

謝謝。我們的問答環節已經結束。我想請大家繼續發表最後評論。

Thank you all for participating in the call today and for your questions. The IR team will be available for the rest of the day for follow up. Thank you and goodbye.

感謝大家今天參加電話會議並提出問題。投資者關係團隊將在當天剩餘時間繼續跟進。謝謝大家，再見。

Thank you. That does conclude today's teleconference and webcast. We disconnect your line at this time and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議和網路直播到此結束。我們暫時關閉您的電話，祝您有美好的一天。感謝您今天的參與。