默克藥廠 (MRK) 2025 Q4 法說會逐字稿

內容摘要

  1. 摘要
    • Q4 2025 營收為 164 億美元,年增 5%(不含匯率影響為 4%);EPS 為 2.04 美元
    • 2026 年營收指引為 655-670 億美元,年增 1-3%;EPS 指引為 5-5.15 美元(含一次性 Cidara 併購費用)
    • GARDASIL 疫苗在中國與日本需求下滑,拖累疫苗事業表現;KEYTRUDA、Animal Health 及新產品線維持成長
  2. 成長動能 & 風險
    • 成長動能:
      • KEYTRUDA 於多項癌症適應症持續擴大滲透,QLEX 劑型上市獲正面回饋
      • WINREVAIR、OHTUVAYRE 等新產品推動心臟代謝與呼吸領域成長
      • Cidara 及 Verona 併購強化呼吸與感染疾病產品線,MK-1406(流感長效抗病毒)具 50 億美元以上潛力
      • 動物保健事業持續穩健成長,預期至 2030 年中期規模翻倍
      • 管線多元,2026-2027 年將有多項關鍵三期數據讀取,預計 2030 年中期潛在商機達 700 億美元
    • 風險:
      • GARDASIL 疫苗於中國、日本需求大幅下滑,疫苗事業短期承壓
      • 2026 年面臨約 25 億美元的學名藥競爭與 IRA 價格壓力,主要影響 JANUVIA、BRIDION、DIFICID
      • LAGEVRIO 銷售顯著下滑,Koselugo 合約重組亦帶來逆風
  3. 核心 KPI / 事業群
    • KEYTRUDA 家族:銷售 84 億美元,年增 5%,受惠於早期癌症滲透與女性腫瘤適應症
    • WELIREG:銷售 2.2 億美元,年增 37%,美國腎細胞癌適應症推動
    • GARDASIL:銷售 10 億美元,年減 35%,中國、日本需求下滑
    • CAPVAXIVE(肺炎疫苗):銷售 2.79 億美元,上市進展順利
    • WINREVAIR:銷售 4.67 億美元,持續強勁成長,全球推廣中
    • OHTUVAYRE:銷售 1.78 億美元,Verona 併購後新產品,COPD 市場滲透提升
    • Animal Health:銷售年增 6%,其中家畜業務年增 9%,寵物業務持平
  4. 財務預測
    • 2026 年營收預估 655-670 億美元,年增 1-3%
    • 2026 年毛利率預估約 82%
    • 2026 年 CapEx 未明確揭露
  5. 法人 Q&A
    • Q: CD388(MK-1406)流感長效抗病毒臨床進度與中期數據揭露時點?
      A: 北半球已完成收案,南半球同步進行,強調需涵蓋多族群與流感季,尚未公布中期數據揭露計畫,但對該產品長期需求具信心。
    • Q: sac-TMT(TROP2 ADC)開發策略是否過於保守?是否規劃進入 NSCLC 一線或與 KEYNOTE-189 對比?
      A: sac-TMT 視為有潛力成為同類最佳 ADC,現有 16 項三期試驗,開發策略涵蓋多腫瘤類型,部分為首創,部分為差異化,強調開發野心不亞於同業。
    • Q: KEYTRUDA 美國專利期與 QLEX 劑型導入時程如何影響 LOE 預期?
      A: 原始化合物專利至 2028 年底,另有兩項專利分別至 2029 年 5 月與 11 月,內部規劃仍以 2028 年為保守假設,QLEX 劑型預計 2028 年滲透率達 30-40%,將持續推動轉換。
    • Q: HIV 雙藥(islatravir/doravirine)相較三藥標準治療的臨床意義與市場需求?
      A: islatravir 為新一代核苷類藥物,雙藥方案可提供不同選擇,特別是可避開 integrase 抑制劑,對於代謝與長期治療具潛在優勢,且正推動每週一次口服方案,為市場首創。
    • Q: WINREVAIR 上市兩年,實際用藥持續性與安全性如何?未來適應症拓展規劃?
      A: WINREVAIR 已重塑 PAH 標準治療,累計逾 9,100 名患者用藥,依從性高,停藥率與同類產品相當或更佳,安全性與標籤一致,未來將評估更多肺部相關適應症。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Thank you for standing by. Welcome to the Merck & Co., Inc., Rahway, New Jersey, USA fourth-quarter sales, and earnings conference call. (Operator Instructions) This call is being recorded. If you have any objections, you may disconnect at this time.

    感謝您的耐心等待。歡迎參加美國新澤西州拉威市默克公司第四季銷售和收益電話會議。(操作員指示)本次通話正在錄音。如果您有任何異議,可以立即斷開連接。

  • I would now like to turn the conference over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin.

    現在我將把會議交給投資者關係高級副總裁彼得·丹嫩鮑姆先生。先生,您可以開始了。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thank you, Shirley, and good morning, everyone. Welcome to the fourth-quarter 2025 conference call for Merck & Co., Inc. Rahway, New Jersey, USA. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer; Caroline Litchfield, Chief Financial Officer; and Dr. Dean Lee, President of Research Labs.

    謝謝你,雪莉,大家早安。歡迎參加美國新澤西州拉威市默克公司 2025 年第四季業績電話會議。出席今天電話會議的有:董事長兼執行長羅伯戴維斯;財務長卡洛琳利奇菲爾德;以及研究實驗室總裁迪恩李博士。

  • Before we get started, I'd like to point out that we have items in our GAAP results such as acquisition-related charges, restructuring costs and certain other items that we have excluded from our non-GAAP results. There is a reconciliation in our press release. I will also remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the Safe Harbor provision of the US Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of our company's management and are subject to significant risks and uncertainties.

    在開始之前,我想指出,我們的 GAAP 結果中包含一些項目,例如收購相關費用、重組成本以及其他一些項目,這些項目已從我們的非 GAAP 結果中排除。我們的新聞稿中已達成和解。我還要提醒各位,我們今天所作的一些陳述可能被視為1995年美國私人證券訴訟改革法案安全港條款意義上的前瞻性陳述。此類聲明是基於本公司管理層目前的信念,但存在重大風險和不確定性。

  • If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2024 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck & Co., Inc., Rahway, New jersey, USA, undertakes no obligation to publicly update any forward-looking statements.

    如果我們的基本假設被證明是不準確的,或者不確定因素成為現實,則實際結果可能與前瞻性聲明中列出的結果有重大差異。我們在提交給美國證券交易委員會的文件,包括 2024 年 10-K 表格中的第 1A 項,列出了某些風險因素和警示性聲明,這些因素和聲明可能導致公司的實際業績與我們今天早上發表的任何前瞻性聲明中預測的業績存在重大差異。美國新澤西州拉威市默克公司不承擔公開更新任何前瞻性聲明的義務。

  • During today's call, a slide presentation will accompany our speakers' prepared remarks. These slides, along with the earnings release, today's prepared remarks and our SEC filings are all posted to the Investor Relations section of our company's website.

    在今天的電話會議上,我們將配合幻燈片演示,向發言人發表準備好的演講。這些幻燈片,連同盈利報告、今天的準備好的發言稿和我們向美國證券交易委員會提交的文件,都已發佈在我們公司網站的投資者關係部分。

  • With that, I'd like to turn the call to Rob.

    接下來,我想把電話交給羅布。

  • Robert Davis - Chairman and CEO

    Robert Davis - Chairman and CEO

  • Thanks, Peter. Good morning and thank you for joining today's call. Our company's purpose to save and improve lives guides everything we do. In 2025, we advanced key programs across all phases of development, furthering our mission to deliver transformative medicines and vaccines that will improve health outcomes for patients around the world. I'm very proud of the significant progress we are making.

    謝謝你,彼得。早安,感謝各位參加今天的電話會議。我們公司以拯救和改善生命為宗旨,引導我們的一切行動。2025年,我們推動了各個發展階段的關鍵項目,進一步實現了我們的使命,即提供變革性的藥物和疫苗,以改善世界各地患者的健康狀況。我為我們取得的顯著進展感到非常自豪。

  • And as we look ahead, we'll remain intently focused on bringing forward breakthrough science and innovation, which is the foundation for creating sustainable long-term value for both patients and shareholders. The transformation of our portfolio is well underway and momentum is building as we continue to execute on our strategy.

    展望未來,我們將繼續專注於推動突破性科學和創新,這是為患者和股東創造可持續長期價值的基礎。我們的投資組合轉型正在順利進行,隨著我們繼續執行策略,轉型動能正在增強。

  • In 2025, our business benefited from successful new product launches, the advancement of important clinical programs and the expansion of our respiratory and infectious disease portfolios through the acquisitions of Verona Pharma and Cidara Therapeutics.

    2025 年,我們的業務受益於新產品的成功推出、重要臨床項目的推進以及透過收購 Verona Pharma 和 Cidara Therapeutics 擴大了我們的呼吸系統和傳染病產品組合。

  • As a result of this progress, we now have line of sight to over $70 billion of potential commercial opportunity by the mid-2030s, $20 billion more than just a year ago and more than double consensus 2028 peak KEYTRUDA revenue of $35 billion. While we still have more to do, this meaningful progress further bolsters my already high confidence in our ability to deliver sustainable growth post the KEYTRUDA LOE period.

    由於這一進展,我們現在可以看到到 2030 年代中期超過 700 億美元的潛在商業機會,比一年前增加了 200 億美元,並且是 KEYTRUDA 2028 年峰值收入 350 億美元的共識預測的兩倍多。雖然我們還有更多工作要做,但這一意義重大的進展進一步增強了我對我們在 KEYTRUDA LOE 時期結束後實現可持續增長能力的信心。

  • Now turning to our results and initial outlook for 2026. Growth in 2025 reflects demand for our innovative portfolio, including for KEYTRUDA, which continues to benefit more patients with cancer globally, increasing contributions from new launches in cardiometabolic and respiratory as well as vaccines and strong performance of Animal Health. We're well positioned to achieve commercial success across key products in 2026, while we make important investments behind our new product launches and expanded pipeline, which Caroline will speak to momentarily.

    現在來看看我們的業績和2026年的初步展望。2025 年的成長反映了對我們創新產品組合的需求,包括 KEYTRUDA,該產品繼續惠及全球更多癌症患者,心血管代謝和呼吸系統以及疫苗領域的新產品推出貢獻不斷增加,動物保健業務表現強勁。我們已做好充分準備,將在 2026 年憑藉關鍵產品取得商業成功,同時我們也在對新產品發布和擴大產品線進行重要投資,卡羅琳稍後將對此進行介紹。

  • Our research colleagues continue to achieve remarkable progress across our broad and deep pipeline. Focusing on a few key events from the fourth-quarter in cardiometabolic and respiratory. At AHA, we presented Phase III results for enlicitide that underscore the practice-changing potential of an oral PCSK9 inhibitor. Cardiovascular disease is the leading cause of death globally, and we look forward to bringing a potential new option to help address the CV epidemic.

    我們的研究同事們在廣泛而深入的研發管線中不斷取得顯著進展。重點關注第四季度心血管代謝和呼吸系統方面的一些關鍵事件。在 AHA 會議上,我們展示了 enlicitide 的 III 期臨床試驗結果,強調了口服 PCSK9 抑制劑改變臨床實踐的潛力。心血管疾病是全球首要死因,我們期待帶來潛在的新選擇來幫助應對心血管疾病的流行。

  • For WINREVAIR, we announced Phase II top line findings from the CADENCE trial that are supportive of its continued development in a different type of pulmonary hypertension. And building on recent momentum in HIV, we shared positive top line results for islatravir in combination with doravirine for treatment-naive adults living with HIV.

    對於 WINREVAIR,我們發表了 CADENCE 試驗的 II 期主要研究結果,這些結果支持其在不同類型的肺動脈高壓中繼續開發。繼近期在 HIV 領域取得的良好勢頭之後,我們分享了 islatravir 與 doravirine 聯合治療 HIV 初治成年患者的積極初步結果。

  • Finally, we're pleased that both enlicitide and sac-TMT, our investigational TROP2 directed antibody drug conjugate, were granted commissioners' national priority vouchers by the FDA, which may expedite review of these important investigational candidates after applications are filed.

    最後,我們很高興地宣布,我們的在研TROP2靶向抗體藥物偶聯物enlicitide和sac-TMT均獲得了FDA授予的專員國家優先憑證,這可能會加快這些重要的在研候選藥物提交申請後的審查。

  • We recently completed the acquisition of Cidara, which complements our portfolio and builds on our long legacy in combating infectious diseases. MK-1406, formerly CD388 is a potentially first-in-class long-acting antiviral candidate designed to help prevent influenza infection in individuals at higher risk of developing serious complications.

    我們最近完成了對 Cidara 的收購,這完善了我們的產品組合,並鞏固了我們在對抗傳染病方面的悠久傳統。MK-1406(原名 CD388)是一種潛在的首創長效抗病毒候選藥物,旨在幫助預防有發生嚴重併發症風險較高的人感染流感。

  • There is a substantial unmet need for influenza prevention in a large at-risk population, and Phase II results were very promising. We believe MK-1406 has greater than $5 billion in revenue potential and can be a meaningful driver of growth later this decade and through the next. We're excited to welcome the Cidara team to our company and look forward to advancing this novel preventative antiviral agent.

    大量高風險族群對流感預防有巨大的未滿足需求,而 II 期試驗結果非常令人鼓舞。我們相信 MK-1406 具有超過 50 億美元的收入潛力,並能在本十年後期和下一個十年成為重要的成長驅動力。我們非常高興地歡迎 Cidara 團隊加入我們公司,並期待推進這種新型預防性抗病毒藥物的研發。

  • Today, our business is anchored by an important set of commercial products that address critical unmet needs. We're also executing on the transformation of our portfolio with initial launches from over 20 potential new growth drivers that have the promise to advance the practice of medicine and change patient lives. Ten of these programs could be substantially clinically derisked over the next two years and represent the majority of our $70 billion of non-risk-adjusted commercial opportunity by the mid-2030s.

    如今,我們的業務以一系列重要的商業產品為支撐,這些產品滿足了關鍵的未被滿足的需求。我們也在推動產品組合轉型,初步推出了 20 多個潛在的新成長驅動因素,這些因素有望推動醫學實踐並改變患者的生活。未來兩年內,其中十個項目的臨床風險可能會大幅降低,到 2030 年代中期,這些項目將占我們 700 億美元非風險調整商業機會的大部分。

  • And our long-term outlook is further bolstered by the strong growth we expect in our Animal Health business by the many early phase programs that will enter Phase II in the near term and through additional potential science-led, disciplined and value-enhancing business development.

    我們動物保健業務的強勁成長預期進一步增強了我們的長期前景,這得益於許多早期計畫將在近期進入 II 期,以及其他潛在的以科學為導向、嚴謹且能提升價值的業務發展。

  • We're entering a particularly robust period of first-time Phase III data readouts for novel candidates. In 2026, these include islatravir combined with lenacapavir, potentially the first once-weekly oral treatment regimen for people living with HIV; MK-3000, potentially the first new mechanism of action in two decades for patients with certain retinal diseases; and tulisokibart, where we expect to see Phase III results in ulcerative colitis as well as Phase II data in other autoimmune diseases.

    我們正進入一個新候選藥物首次公佈 III 期臨床試驗數據的強勁時期。2026 年,這些藥物包括 islatravir 與 lenacapavir 的聯合用藥,這可能是首個用於治療 HIV 感染者的每週一次口服治療方案;MK-3000,這可能是二十年來首個用於治療某些視網膜疾病的新作用機制藥物;以及 tulisokibart,我們預計將看到其在 III 期性結腸炎方面的臨床數據的臨床數據。

  • There is an even richer array of expected readouts in 2027, including Phase III results for sac-TMT, which we believe is a differentiated TROP2 ADC. For I-DXd, our B7-H3 antibody drug conjugate being studied in small cell lung cancer and other tumor types for MK-1406 as well as for a number of other important programs.

    2027 年預計將有更豐富的讀數公佈,包括 sac-TMT 的 III 期結果,我們認為它是一種差異化的 TROP2 ADC。對於 I-DXd,我們正在研究其 B7-H3 抗體藥物偶聯物,用於治療小細胞肺癌和其他腫瘤類型,用於 MK-1406 以及其他一些重要項目。

  • In summary, we're successfully executing multiple product launches, making significant clinical advancements, and augmenting our pipeline with strategic business development. We're also making the necessary investments that will sustain our success over the long term. Our progress and momentum positions us to continue delivering on our purpose for patients and create durable value for shareholders.

    總而言之,我們正在成功推出多款產品,取得重大臨床進展,並透過策略性業務發展來擴充我們的產品線。我們也在進行必要的投資,以維持長期的成功。我們的進展和發展勢頭使我們能夠繼續履行對患者的使命,並為股東創造持久價值。

  • I want to recognize and thank our global teams for their commitment. While there is more to do, the actions taken, the progress we've made and our continued disciplined execution provide me with strong confidence that we're well positioned for our next chapter of success.

    我要感謝我們全球團隊的付出和奉獻。雖然還有更多工作要做,但我們採取的行動、取得的進展以及我們持續的嚴謹執行讓我堅信,我們已經為下一個成功篇章做好了充分準備。

  • With that, I'll turn the call over to Caroline.

    這樣,我就把電話交給卡洛琳了。

  • Caroline Litchfield - Chief Financial Officer, Executive Vice President

    Caroline Litchfield - Chief Financial Officer, Executive Vice President

  • Thank you, Rob. Good morning. As Rob noted, in 2025, we made meaningful progress in benefiting patients and customers around the world with our portfolio of innovative medicines and vaccines. Our business delivered growth, driven by continued strength in oncology and Animal Health as well as increasing contributions from new product launches.

    謝謝你,羅布。早安.正如羅布所指出的,到 2025 年,我們將憑藉我們創新藥物和疫苗組合,為世界各地的患者和客戶帶來福祉,並取得有意義的進展。在腫瘤學和動物保健領域持續強勁發展以及新產品上市帶來的貢獻不斷增加的推動下,我們的業務實現了成長。

  • These results demonstrate the enduring strength of our business and give us confidence in our outlook as we enter a period with many new launches. Our commercial and operational execution enable us to invest in discovering, developing, and launching the next generation of innovations, which will drive long-term value for patients, customers, and shareholders.

    這些結果證明了我們業務的持久實力,也讓我們對未來充滿信心,因為我們即將迎來許多新產品的發布期。我們的商業和營運執行力使我們能夠投資於下一代創新成果的發現、開發和推出,這將為患者、客戶和股東帶來長期價值。

  • Now turning to our fourth-quarter results. Total company revenues were $16.4 billion, an increase of 5% or 4% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis. In oncology, sales of the KEYTRUDA family of products, which includes KEYTRUDA and KEYTRUDA QLEX increased 5% to $8.4 billion, with global growth driven by robust uptake in earlier-stage cancers and strong demand for metastatic indications. Utilization in tumors that primarily affect women, including breast, cervical and endometrial cancers, continues to be a key contributor to growth.

    現在來看我們第四季的業績。公司總營收為 164 億美元,成長 5%,若不計匯率影響,則成長 4%。以下收入說明將以除息價格為基礎。在腫瘤領域,KEYTRUDA 系列產品(包括 KEYTRUDA 和 KEYTRUDA QLEX)的銷售額成長了 5%,達到 84 億美元,全球成長主要得益於早期癌症的強勁接受度和轉移性適應症的強勁需求。針對主要影響女性的腫瘤(包括乳癌、子宮頸癌和子宮內膜癌)的治療仍然是推動成長的關鍵因素。

  • In addition, we saw increased use of KEYTRUDA in combination with PADCEV in locally advanced or metastatic urothelial cancer. In the US, growth was negatively impacted by approximately $200 million due to the timing of purchases. We are pleased with the positive provider feedback following the recent launch of KEYTRUDA QLEX. As expected, sales in the quarter were $35 million.

    此外,我們也看到 KEYTRUDA 與 PADCEV 合併用於治療局部晚期或轉移性尿路上皮癌的情況增加。在美國,由於購買時機不當,經濟成長受到了約 2 億美元的負面影響。我們對 KEYTRUDA QLEX 近期推出後收到的正面供應商回饋感到滿意。正如預期,該季度銷售額為 3500 萬美元。

  • We look forward to having a greater impact on patients and health care systems following implementation of a permanent J-code in the US, which we continue to expect to occur in the beginning of April. Our broader oncology portfolio achieved another quarter of strong growth. Notably, WELIREG sales increased 37% to $220 million, predominantly driven by increased use in certain patients with previously treated advanced renal cell carcinoma in the US as well as continued uptake from ongoing launches in certain international markets.

    我們期待在美國實施永久性 J 代碼後,對患者和醫療保健系統產生更大的影響,我們仍然預計這將在 4 月初發生。我們更廣泛的腫瘤產品組合又實現了一個季度的強勁成長。值得注意的是,WELIREG 的銷售額增長了 37%,達到 2.2 億美元,這主要得益於美國某些先前接受過治療的晚期腎細胞癌患者的使用量增加,以及某些國際市場持續推出該產品帶來的持續增長。

  • We look forward to potentially reaching more patients with renal cell carcinoma following positive data from the LITESPARK-011 and LITESPARK-022 studies. In vaccines, GARDASIL sales were $1 billion, a decrease of 35%, driven by lower demand in China and Japan. Other international markets grew 8%, benefiting from the timing of purchases. In the US, sales grew 7%, largely due to price. In pneumococcal, the CAPVAXIVE launch continues to progress well with sales of $279 million, driven by demand from both retail pharmacies and non-retail customers, including uptake from increased seasonal immunization activity in the US.

    我們期待在 LITESPARK-011 和 LITESPARK-022 研究取得正面數據後,能夠幫助更多腎細胞癌患者。在疫苗方面,加衛苗(GARDASIL)的銷售額為 10 億美元,下降了 35%,主要原因是中國和日本的需求下降。其他國際市場成長了 8%,受益於採購時機的掌握。在美國,銷售額成長了7%,主要原因是價格上漲。在肺炎球菌方面,CAPVAXIVE 的上市進展順利,銷售額達 2.79 億美元,這得益於零售藥局和非零售客戶的需求,其中包括美國季節性免疫接種活動增加帶來的市場需求。

  • In RSV, ENFLONSIA sales were $21 million. Initial uptake has been constrained by a lower-than-expected infant immunization rate, coupled with high levels of total RSV monoclonal antibody inventory in the market.

    在 RSV 中,ENFLONSIA 的銷售額為 2,100 萬美元。由於嬰兒免疫接種率低於預期,加上市場上 RSV 單株抗體總庫存量較高,初期市場接受度受到限制。

  • In cardiometabolic and respiratory, WINREVAIR continues to have a positive impact for patients with pulmonary arterial hypertension. Global sales were $467 million, a reflection of the continued strong demand for this important treatment.

    在心血管代謝和呼吸系統方面,WINREVAIR 繼續對肺動脈高壓患者產生積極影響。全球銷售額達 4.67 億美元,反映市場對這種重要療法的持續強勁需求。

  • In the US, more than 1,500 new patients received a prescription and over 27,000 total prescriptions were dispensed. We also saw an increase in the proportion of patients whose background therapies do not include a prostacyclin. Outside the US, we continue to progress with securing approvals and reimbursement.

    在美國,超過 1500 名新患者獲得了處方,總共發放了超過 27,000 張處方。我們也發現,背景治療方案中不含前列環素的患者比例增加。在美國以外,我們在獲得批准和報銷方面繼續取得進展。

  • We are excited to build upon the successful US launch of OHTUVAYRE, a maintenance treatment for adults with COPD with a novel mechanism of action. In the quarter, sales were $178 million, reflecting revenues following the acquisition of Verona on October 7.

    我們很高興能夠以 OHTUVAYRE 在美國成功上市為基礎,OHTUVAYRE 是一種用於治療成人 COPD 的維持性藥物,具有全新的作用機轉。本季銷售額為 1.78 億美元,反映了 10 月 7 日收購 Verona 後的收入。

  • We delivered strong growth in new patient starts and total patients treated. We also saw physicians prescribe OHTUVAYRE to more of their patients and an increase in the total number of prescribing physicians. As a reminder, we expect seasonality in the early part of the year as Medicare deductibles are reset. We are making investments to maximize the ongoing launch in the US and look forward to benefiting more adult patients with COPD.

    我們在新增患者數量和總治療患者數量方面均實現了強勁增長。我們還發現,醫生們給更多患者開了 OHTUVAYRE 處方,開處方的醫生總數也有所增加。提醒各位,由於醫療保險自付額重置,我們預計年初會出現季節性波動。我們正在進行投資,以最大限度地提高在美國的持續推廣,並期待能使更多患有慢性阻塞性肺病的成年患者受益。

  • Our Animal Health business delivered another quarter of strong growth with sales increasing 6%. Livestock sales grew 9%, driven by higher demand across all species. Companion animal sales were flat as growth from new product launches was offset by a reduction in vet visits.

    我們的動物保健業務連續第二個季度實現強勁成長,銷售額成長了 6%。受各類牲畜需求成長的推動,牲畜銷售額成長了9%。寵物銷售量持平,因為新產品上市帶來的成長被獸醫就診次數的減少所抵消。

  • I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin was 79.7%, a decrease of 1.1-percentage-points due to higher inventory reserves, partially offset by favorable product mix. Operating expenses decreased to $6.8 billion. A charge of $150 million related to an agreement with Dr. Falk Pharma to acquire sole global rights to MK-8690 was lower than the $700 million in business development charges a year ago.

    接下來,我將帶您了解我們損益表的剩餘部分,我的評論將以非GAAP準則為基礎。毛利率為 79.7%,較上年同期下降 1.1 個百分點,原因是庫存儲備增加,但有利的產品組合部分抵消了這一影響。營運支出減少至68億美元。與 Dr. Falk Pharma 達成協議,獲得 MK-8690 的全球獨家權利相關的 1.5 億美元費用,低於一年前的 7 億美元業務發展費用。

  • Excluding these charges, operating expenses were flat, reflecting an increase in investment in support of our innovative pipeline and key growth drivers, offset by the benefits of our multiyear optimization initiative. Other expense was $226 million. Our tax rate was 15.4%. Taken together, earnings per share were $2.04.

    除這些費用外,營運支出持平,這反映出我們為支持創新產品線和關鍵成長驅動因素而增加的投資,但被我們多年優化計劃帶來的收益所抵消。其他支出為2.26億美元。我們的稅率是15.4%。合計,每股收益為 2.04 美元。

  • Now turning to our 2026 non-GAAP guidance. We expect revenue to be between $65.5 billion and $67 billion, representing growth of 1% to 3%, including a positive impact from foreign exchange of approximately 1-percentage-point using mid-January rates. Our gross margin assumption is approximately 82%. Operating expenses are assumed to be between $35.9 billion and $36.9 billion, which includes a onetime charge of approximately $9 billion related to the acquisition of Cidara. As a reminder, our guidance does not assume additional significant potential business development transactions.

    現在來看看我們 2026 年的非 GAAP 財務指引。我們預計營收將在 655 億美元至 670 億美元之間,成長 1% 至 3%,其中包括使用 1 月中旬匯率計算的約 1 個百分點的外匯正面影響。我們的毛利率假設約為 82%。營運費用預計在 359 億美元至 369 億美元之間,其中包括與收購 Cidara 相關的約 90 億美元的一次性費用。需要提醒的是,我們的建議並沒有假設會有其他重大的潛在業務發展交易。

  • Other expense of approximately $1.3 billion includes financing costs for Cidara and Verona. We assume a full year tax rate between 23.5% and 24.5%, which reflects the non-tax deductible onetime charge for Cidara. We assume approximately 2.48 billion shares outstanding. Taken together, we expect EPS of $5 to $5.15 with a midpoint of $5.08, including a positive impact from foreign exchange of approximately $0.10 using mid-January rates.

    其他約 13 億美元的支出包括 Cidara 和 Verona 的融資成本。我們假設全年稅率在 23.5% 到 24.5% 之間,這反映了 Cidara 的一次性不可抵稅費用。我們假設流通股約為 24.8 億股。綜合來看,我們預計每股收益為 5 美元至 5.15 美元,中間值為 5.08 美元,其中包括使用 1 月中旬匯率計算的約 0.10 美元的外匯正面影響。

  • Excluding approximately $3.65 per share related to the upfront charge for the acquisition of Cidara as well as $0.30 per share of ongoing costs to advance MK-1406 and finesta transaction, our midpoint would be $9.03. As you consider your models, there are a few items to keep in mind.

    扣除與收購 Cidara 相關的約 3.65 美元/股的前期費用以及推進 MK-1406 和 Finesta 交易的 0.30 美元/股的持續成本後,我們的中位數應為 9.03 美元。當您考慮模型時,請注意以下幾點。

  • We expect to deliver growth in 2026, driven by increasing contributions from our new launches as well as continued strength in oncology and Animal Health despite a headwind of approximately $2.5 billion from generic competition, IRA price setting, and the restructured agreement for Koselugo. Generic competition primarily impacts the JANUVIA family of products, BRIDION and DIFICID. We also expect significantly lower sales of LAGEVRIO due to continued soft demand.

    我們預計在 2026 年實現成長,這得益於新產品的不斷推出以及腫瘤學和動物保健領域的持續強勁表現,儘管面臨仿製藥競爭、IRA 定價以及 Koselugo 重組協議帶來的約 25 億美元的不利因素。仿製藥競爭主要影響捷諾維 (JANUVIA)​​ 系列產品、百多邦 (BRIDION) 和迪菲西德 (DIFICID)。由於需求持續疲軟,我們預期 LAGEVRIO 的銷售量也將大幅下降。

  • Now turning to capital allocation, where our strategy remains unchanged. We will prioritize investments in our business to drive near- and long-term growth, including new product launches and our robust pipeline. We remain committed to the dividend with the goal of increasing it over time. Business development remains a high priority. We are well positioned to pursue additional transactions when science and value align. Our guidance assumes approximately $3 billion of share repurchases, and we remain committed to not having excess cash build on the balance sheet.

    現在來說說資本配置,我們的策略維持不變。我們將優先投資於我們的業務,以推動近期和長期成長,包括推出新產品和我們強大的產品線。我們將繼續致力於派發股息,並計劃隨著時間的推移逐步提高股息水準。業務拓展仍是重中之重。當科學與價值相契合時,我們已做好充分準備進行更多交易。我們的預期是回購約 30 億美元的股票,我們仍然致力於不讓資產負債表上累積過多的現金。

  • To conclude, we entered 2026 with confidence in the outlook for our business, driven by global demand for our innovative medicines and vaccines, including the exciting progress of our many launches and upcoming clinical milestones from our promising pipeline. We maintain our long-standing commitment to bringing forward medically significant innovations that will enable us to deliver value to patients, customers, and shareholders well into the future.

    總而言之,我們滿懷信心地進入 2026 年,對公司業務前景充滿信心,這得益於全球對我們創新藥物和疫苗的需求,包括我們眾多產品的上市進展以及我們前景光明的產品線即將取得的臨床里程碑。我們始終致力於推出具有重大醫學意義的創新,這將使我們能夠在未來很長一段時間內為患者、客戶和股東創造價值。

  • With that, I'd now like to turn the call over to Dean.

    那麼,我現在想把電話交給迪恩。

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • Thank you, Caroline. Good morning, everyone. Progress continues across programs spanning multiple therapeutic areas. Today, I will provide updates across cardiometabolic and respiratory, infectious disease and oncology programs, then conclude with a summary of highlights from 2025 and upcoming milestones for this year.

    謝謝你,卡洛琳。各位早安。涵蓋多個治療領域的各項計劃均持續取得進展。今天,我將介紹心血管代謝和呼吸系統、傳染病和腫瘤學計畫的最新進展,最後總結 2025 年的重點工作和今年即將迎來的里程碑。

  • Starting with advancements across our cardiometabolic and respiratory pipeline and programs. Enlicitide, our investigational oral PCSK9 inhibitor has been designed to deliver antibody-like efficacy while offering a simple once-daily oral treatment option with the potential to help address the CV epidemic.

    首先從我們在心血管代謝和呼吸系統產品線及專案方面取得的進展說起。Enlicitide 是我們正在研究的口服 PCSK9 抑制劑,旨在提供類似抗體的療效,同時提供一種簡單的每日口服治療方案,有望幫助解決 CV 流行問題。

  • Data from two Phase III studies evaluating enlicitide for the treatment of adults with elevated LDL cholesterol were presented at the American Heart Association Scientific Sessions in November. In both the CORALreef Lipids study, which included a broad population of adults with or at risk for atherosclerotic cardiovascular disease on background lipid-lowering therapies or with statin intolerance and the CORALreef HeFH study in adults with familial heterozygous hypercholesterolemia, enlicitide demonstrated statistically significant sustained reductions in multiple atherogenic factors, including LDL-C, ApoB, non-HDL-C and Lp(a).

    11 月,美國心臟協會科學會議公佈了兩項評估恩利西肽治療成人高 LDL 膽固醇的 III 期研究數據。在 CORALreef Lipids 研究(該研究納入了廣泛的患有或有患動脈粥樣硬化性心血管疾病風險的成年人,他們正在接受背景降脂治療或對他汀類藥物不耐受)和 CORALreef HeFH 研究(該研究納入了患有家族性雜合子高膽固醇血症的成年人)中,恩利西肽均顯示出對非南樣因素(D-A-B-B). Lp(a))的統計學意義上的持續降低。

  • The findings from the CORALreef HeFH were published in the Journal of the American Medical Association and from CORALreef Lipids have been accepted to the New England Journal of Medicine. In addition, positive results of the third Phase III trial, CORALreef AddOn, evaluating enlicitide comparing to other oral non-statin therapies in adults with hypercholesterolemia and treated with a statin will be presented at the American College of Cardiology Congress in March.

    CORALreef HeFH 的研究結果已發表在《美國醫學會雜誌》上,CORALreef Lipids 的研究結果已被《新英格蘭醫學雜誌》接受。此外,第三項 III 期試驗 CORALreef AddOn 的積極結果將於 3 月在美國心臟病學會大會上公佈。該試驗評估了 enlicitide 與其他口服非他汀類藥物在接受他汀類藥物治療的高膽固醇血症成年患者中的療效。

  • The Phase III CORALreef outcome study is ongoing and fully enrolled. For WINREVAIR, we continue to make progress on our global regulatory strategy. Last month, the European Commission approved an expanded indication in adults with pulmonary arterial hypertension with WHO functional Class II, III and IV based on the Phase III ZENITH study. We are continuing to evaluate WINREVAIR in an additional indication associated with progressive vascular remodeling and resistance.

    CORALreef III期療效研究正在進行中,且已完成全部受試者招募。對於 WINREVAIR 而言,我們在全球監管策略方面持續取得進展。上個月,歐盟委員會根據 III 期 ZENITH 研究,批准了該藥物在 WHO 功能分級 II、III 和 IV 級肺動脈高壓成人患者中的適應症擴大。我們正在繼續評估 WINREVAIR 在與進行性血管重塑和阻力相關的其他適應症中的應用。

  • The Phase II CADENCE study met its primary endpoint, achieving statistically significant and clinically meaningful reduction of pulmonary vascular resistance compared to placebo in adults with combined post and pre-capillary pulmonary hypertension due to heart failure with preserved ejection fraction. These findings support proof of concept, which will inform a Phase III program in this population. Detailed results will also be presented at the American College of Cardiology Congress in March.

    II 期 CADENCE 研究達到了其主要終點,與安慰劑相比,在射血分數保留的心臟衰竭引起的合併毛細血管後和毛細血管前肺動脈高壓的成年患者中,肺血管阻力實現了統計學上顯著且臨床上有意義的降低。這些發現支持概念驗證,這將為針對該族群的 III 期臨床試驗計畫提供基礎。詳細結果將於三月在美國心臟學會大會上公佈。

  • Next, infectious disease. Last month, we completed the acquisition of Cidara Therapeutics. The scale of the ongoing seasonal flu outbreak in the Northern Hemisphere reinforces the threat posed by influenza, the corresponding burden on health care systems and importantly, the need for improved prevention strategies, specifically for those individuals at high risk of serious complications.

    其次是傳染病。上個月,我們完成了對 Cidara Therapeutics 的收購。北半球持續爆發的季節性流感疫情規模,凸顯了流感帶來的威脅、對醫療保健系統造成的相應負擔,以及更重要的是,需要改進預防策略,特別是針對那些有嚴重併發症高風險的人。

  • The Phase III ANCHOR study evaluating MK-1406, a potentially first-in-class long-acting preventative strain-agnostic antiviral with a differentiated mechanism of action completed enrollment in November in the Northern Hemisphere. In parallel, we will enroll participants in the Southern hemisphere to ensure the collection of a robust data set spanning a broad patient population, including adults who are immunocompromised and to capture additional data on diverse circulating strains.

    評估 MK-1406(一種具有差異化作用機制的潛在首創的長效預防性抗病毒藥物,不區分株)的 III 期 ANCHOR 研究已於 11 月在北半球完成招募。同時,我們將招募南半球的參與者,以確保收集涵蓋廣泛患者群體(包括免疫功能低下的成年人)的可靠數據集,並獲取有關各種循環病毒株的更多數據。

  • Furthermore, it is also important for the study to encompass those who have been vaccinated against the flu and those who have not.

    此外,這項研究還必須涵蓋已接種流感疫苗的人和未接種流感疫苗的人。

  • Turning to HIV. In November, we announced positive top line results for our investigational once-daily, single-tablet 2-drug regimen of doravirine and islatravir, a next-generation nucleoside analog leveraging translocation inhibition from a Phase III study in previously untreated adults with HIV-1 infection. This is the first 2-drug regimen without an HIV integrase strand transfer inhibitor to demonstrate non-inferior efficacy and safety versus the broadly used 3-drug INSTI-based regimen, Biktarvy.

    轉向愛滋病。11 月,我們宣布了我們正在研究的每日一次、單片雙藥療法 doravirine 和 islatravir 的積極頂線結果,這是一種利用易位抑制的下一代核苷類似物,來自一項針對先前未接受治療的 HIV-1 感染成年人的 III 期研究。這是第一個不含 HIV 整合酶鏈轉移抑制劑的雙藥療法,其療效和安全性與廣泛使用的 3 藥 INSTI 療法 Biktarvy 相比毫不遜色。

  • Based on its potent antiviral properties and barrier to resistance, it is our ambition that islatravir will serve as a novel anchor medicine across multiple 2-drug treatment regimens, providing new daily and weekly options for people living with HIV. Detailed results will be presented at an upcoming medical congress.

    基於其強大的抗病毒特性和抗抗藥性屏障,我們希望伊斯拉曲韋能夠成為多種雙藥治療方案中的一種新型核心藥物,為愛滋病毒感染者提供新的每日和每周用藥選擇。詳細結果將在即將召開的醫學大會上公佈。

  • Moving to oncology. Data continued to demonstrate KEYTRUDA's impact in treating a wide spectrum of cancers. In bladder cancer, there were two recent notable developments. First, the FDA approved KEYTRUDA and KEYTRUDA QLEX, each in combination with PADCEV as neoadjuvant treatment and continued after cystectomy as adjuvant treatment for adults with muscle invasive bladder cancer who are ineligible for cisplatin containing chemotherapy based on the Phase III KEYNOTE-905 trial. This is the first PD-1 inhibitor plus antibody drug conjugate regimen approved for this population.

    轉入腫瘤科。數據持續顯示 KEYTRUDA 在治療多種癌症方面具有療效。膀胱癌領域近期出現了兩個值得關注的進展。首先,FDA 批准了 KEYTRUDA 和 KEYTRUDA QLEX,它們均與 PADCEV 聯合使用,作為新輔助治療,並在膀胱切除術後繼續作為輔助治療,用於治療不適合接受含順鉑化療的肌層浸潤性膀胱癌成人患者。這項批准基於 III 期 KEYNOTE-905 試驗。這是首個獲準用於該族群的PD-1抑制劑合併抗體藥物偶聯療法。

  • Second, we announced positive top line results from the Phase III KEYNOTE-B15 study. The combination of KEYTRUDA plus PADCEV given as neoadjuvant and adjuvant treatment demonstrated statistically significant and clinically meaningful improvements in event-free survival, overall survival and pathologic complete response rates versus neoadjuvant chemotherapy and surgery.

    其次,我們發表了 III 期 KEYNOTE-B15 研究的正面初步結果。KEYTRUDA 合併 PADCEV 作為新輔助和輔助治療,在無事件生存期、總生存期和病理完全緩解率方面,與新輔助化療和手術相比,顯示出統計學上顯著且臨床上有意義的改善。

  • This is the first and only perioperative immunotherapy plus ADC regimen shown to extend survival for cisplatin-eligible patients with muscle-invasive bladder cancer. Detailed results will be presented later this month at the ASCO Genitourinary Cancer Symposium.

    這是第一個也是唯一一個被證實能延長適合接受順鉑治療的肌層浸潤性膀胱癌患者生存期的圍手術期免疫療法加ADC方案。詳細結果將於本月稍晚在ASCO泌尿生殖系統腫瘤研討會上公佈。

  • Together, these regimens have the potential to offer patients with muscle-invasive bladder cancer who are either eligible or ineligible for cisplatin chemotherapy, a KEYTRUDA-based option. Three additional Phase III studies are ongoing evaluating KEYTRUDA across different stages of bladder cancer, including KEYNOTE-992, KEYNOTE-866, and KEYNOTE-676.

    這些方案結合起來,有可能為符合或不符合順鉑化療條件的肌層浸潤性膀胱癌患者提供一種基於 KEYTRUDA 的選擇。目前還有三項 III 期研究正在進行中,評估 KEYTRUDA 在不同階段膀胱癌的療效,包括 KEYNOTE-992、KEYNOTE-866 和 KEYNOTE-676。

  • In collaboration with Moderna, we recently announced five-year follow-up data for the Phase IIb KEYNOTE-942 study evaluating intismeran autogene, an individualized neoantigen therapy candidate in combination with KEYTRUDA in patients with high-risk Stage III or IV melanoma following complete resection. In the follow-up analysis, the study demonstrated a sustained improvement in recurrence-free survival with a 49% reduction in the risk of recurrence or death compared to KEYTRUDA alone, building on the previously announced primary and three-year analysis from the trial.

    我們與 Moderna 合作,最近公佈了 IIb 期 KEYNOTE-942 研究的五年追蹤數據,該研究評估了 intismeran 自體基因(一種個體化新抗原療法候選藥物)與 KEYTRUDA 聯合用於完全切除後高風險 III 期或 IV 期黑色素瘤患者的療效。在後續分析中,研究表明,與單獨使用 KEYTRUDA 相比,復發或死亡風險降低了 49%,無復發生存期得到了持續改善,這一結果建立在先前發表的試驗主要分析和三年分析的基礎上。

  • The Phase III INTerpath-001 trial in adjuvant melanoma is ongoing and fully enrolled. In November, the European Commission approved a subcutaneous injection of pembrolizumab and berahyaluronidase alfa marketed in the EU as KEYTRUDA SC for use in all 33 KEYTRUDA indications for adult patients.

    針對黑色素瘤輔助治療的 III 期 INTerpath-001 試驗正在進行中,且已完成全部受試者招募。11 月,歐盟委員會批准了在歐盟以 KEYTRUDA SC 為商品名銷售的帕博利珠單抗和貝拉亞魯羅尼酶α皮下注射劑,用於成人患者的所有 33 種 KEYTRUDA 適應症。

  • It is the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered in one minute every three weeks or in two minutes every six weeks. The availability of more rapid subcutaneous pembrolizumab administration is being integrated into our clinical development programs.

    它是歐洲首個也是唯一一個皮下注射免疫檢查點抑制劑,可以每三週注射一次,每次只需一分鐘;或每六週注射一次,每次只需兩分鐘。我們正在將更快速的皮下注射帕博利珠單抗技術整合到我們的臨床開發項目中。

  • KANDLELIT-007, a Phase III study evaluating calderasib, an investigational oral selective KRAS G12C inhibitor in combination with KEYTRUDA QLEX for the first-line treatment of patients with KRAS G12C mutant advanced or metastatic non-squamous non-small cell lung cancer.

    KANDLELIT-007 是一項 III 期研究,旨在評估 calderasib(一種正在研究的口服選擇性 KRAS G12C 抑制劑)與 KEYTRUDA QLEX 聯合用於一線治療 KRAS G12C 突變型晚期或轉移性非鱗狀非小細胞肺癌患者的療效。

  • In December, at the American Society of Hematology Annual Meeting, we highlighted progress across our hematology pipeline with positive data spanning multiple candidates, including MK-1045, an investigational CD19 CD3 T-cell engager in adults with relapsed or refractory B-cell acute lymphoblastic leukemia; nemtabrutinib, an investigational noncovalent BTK inhibitor in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma; and bomedemstat, an investigational LSD1 inhibitor in patients with polycythemia vera who are resistant or intolerant to cytoreductive therapy.

    12 月,在美國血液學會年會上,我們重點介紹了血液學研發管線的進展,並公佈了多個候選藥物的積極數據,包括:MK-1045,一種用於治療復發或難治性 B 細胞急性淋巴細胞白血病成人患者的在研 CD19 CD3 T 細胞銜接器;nemtabrutinib,一種用於治療慢性淋巴細胞白血病或細胞白血病在 CTK 的共接者; bomedemstat,一種用於治療對細胞減滅療法抗藥性或不耐受的真性紅血球增多症患者的在研 LSD1 抑制劑。

  • In addition, there are two ongoing Phase III studies evaluating bomedemstat in essential thrombocythemia, an orphan disease. 2025 was marked by significant pipeline progress, including positive data announced from 18 Phase III trials and the initiation of 21 Phase III trials spanning cardiometabolic and respiratory, immunology, infectious disease, oncology and ophthalmology.

    此外,還有兩項正在進行的III期臨床試驗評估bomedemstat治療原發性血小板增多症(一種罕見疾病)的療效。 2025年,公司研發管線取得了顯著進展,包括公佈了18項III期臨床試驗的積極數據,並啟動了21項涵蓋心血管代謝和呼吸系統、免疫學、傳染病、腫瘤學和眼科學等領域的III期臨床試驗。

  • We also secured regulatory approvals across therapeutic areas, including in oncology, KEYTRUDA QLEX and additional KEYTRUDA-based regimens, including in patients with cisplatin-ineligible MIBC and locally advanced head and neck squamous cell carcinoma.

    我們也獲得了包括腫瘤學在內的多個治療領域的監管批准,包括 KEYTRUDA QLEX 和其他基於 KEYTRUDA 的治療方案,用於治療不適合順鉑治療的 MIBC 患者和局部晚期頭頸部鱗狀細胞癌患者。

  • In infectious disease, ENFLONSIA, our long-acting monoclonal antibody for the prevention of respiratory syncytial virus, lower respiratory tract disease in infants born during or entering their first RSV season. And in cardiovascular, the label update for WINREVAIR in PAH.

    在傳染病領域,ENFLONSIA 是一種長效單株抗體,用於預防在 RSV 流行季出生或進入第一個 RSV 流行季的嬰兒的呼吸道合胞病毒下呼吸道疾病。在心血管領域,WINREVAIR 的 PAH 標籤進行了更新。

  • Finally, we continue to deliver on our one pipeline strategy by leveraging our clinical expertise and robust business development capabilities. The acquisition of Verona Pharma and Cidara Therapeutics further strengthen our pipeline and bring forward promising candidates with the potential to serve areas of significant unmet patient need.

    最後,我們繼續利用我們的臨床專業知識和強大的業務發展能力,貫徹我們的單一產品線策略。收購 Verona Pharma 和 Cidara Therapeutics 進一步加強了我們的產品線,並推出了有前途的候選藥物,這些藥物有可能滿足患者尚未得到充分滿足的重大需求。

  • Building on our momentum in 2025, we anticipate a series of milestones across multiple therapeutic areas in the coming months, including in oncology, the February 20 PDUFA date for certain patients with platinum-resistant recurrent ovarian cancer based on the KEYNOTE-B96 trial. Presentation of detailed findings at ASCO GU for WELIREG, our first-in-class oral HIF-2 alpha inhibitor across adjuvant and certain types of advanced renal cell carcinoma based on the Phase III LITESPARK-011 and LITESPARK-022 trials and for KEYNOTE-B15 in cisplatin-eligible patients with MIBC.

    憑藉 2025 年的發展勢頭,我們預計未來幾個月將在多個治療領域取得一系列里程碑式的成就,包括腫瘤學領域,根據 KEYNOTE-B96 試驗,某些鉑耐藥復發性卵巢癌患者的 PDUFA 日期為 2 月 20 日。在 ASCO GU 上,我們詳細介紹了 WELIREG 的治療結果,WELIREG 是我們首創的口服 HIF-2 α 抑制劑,用於輔助治療和某些類型的晚期腎細胞癌,基於 III 期 LITESPARK-011 和 LITESPARK-022 試驗;以及 KEYNOTE-B15 治療,用於治療順鉑的治療。

  • In HIV, the April 28 PDUFA date for doravirine and islatravir, a once-daily oral 2-drug treatment regimen and top line data from the Phase III ISLEND-1 and ISLEND-2 trials evaluating islatravir and lenacapavir as a once-weekly oral 2-drug treatment regimen in collaboration with Gilead.

    在 HIV 領域,多拉韋林和伊斯拉曲韋的 PDUFA 日期為 4 月 28 日,這是一種每日一次口服的雙藥治療方案;此外,還公佈了與吉利德合作開展的 III 期 ISLEND-1 和 ISLEND-2 試驗的主要數據,該試驗評估了伊斯拉曲韋和來那卡帕韋作為每週一次口服治療方案的雙藥治療方案。

  • In cardiometabolic and respiratory, the presentation of detailed results at ACC in March for WINREVAIR from the Phase II CADENCE study in a subset of pulmonary hypertension due to left heart disease. And for enlicitide from the Phase III CORALreef AddOn trial. In immunology, data for tulisokibart, our TL1A inhibitor based on the Phase III ATLAS UC trial in ulcerative colitis and Phase II ATHENA study in SSc-ILD.

    在心血管代謝和呼吸系統方面,3 月在 ACC 上公佈了 WINREVAIR 在 II 期 CADENCE 研究中針對左心疾病引起的肺動脈高壓亞組的詳細結果。以及來自 CORALreef AddOn III 期試驗的 enlicitide。在免疫學方面,我們基於潰瘍性結腸炎 III 期 ATLAS U​​SB 試驗和 SSc-ILD II 期 ATHENA 研究的 TL1A 抑製劑 tulisokibart 的數據。

  • Finally, in ophthalmology, data from the Phase III BRUNELLO study of MK-3000, our novel Wnt agonist being evaluated in diabetic macular edema and the Phase II RIOJA study of MK-8748, our potential first-in-class Tie2 agonist VEGF inhibitor being evaluated for the treatment of certain retinal diseases.

    最後,在眼科領域,我們公佈了 MK-3000(一種新型 Wnt 激動劑)的 III 期 BRUNELLO 研究數據,該藥物正在糖尿病性黃斑水腫中進行評估;以及 MK-8748(一種潛在的首創 Tie2 激動劑 VEGF 抑製劑)的 II 期 RIOJA 研究數據,該藥物正在進行某些視網膜疾病的治療中進行評估。

  • We continue to advance our diversified pipeline with a focus on executing with speed and rigor. I look forward to providing further updates through 2026.

    我們將繼續推動多元化的產品線,重點在於快速、嚴謹地執行。我期待在2026年之前繼續提供最新消息。

  • And now I turn the call back to Peter.

    現在我把電話轉回給彼得。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thank you, Dean. Shirley, we're now ready for Q&A. We have a hard (technical difficulty)

    謝謝你,院長。雪莉,現在進入問答環節。我們面臨一個難題(技術難題)

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Mohit Bansal, Wells Fargo.

    莫希特·班薩爾,富國銀行。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Congrats on all the pipeline progress. Maybe if you can double-click on the CD388 asset and potential for interim here. So the flu season appears to be strong this season. So it would seem like that event rates may be occurring ahead of the plan in the ANCHOR trial. But would love to understand your thoughts around running the full trial.

    祝賀管道建設取得的所有進展。或許您可以雙擊 CD388 資產,看看能否在這裡找到過渡方案。看來今年的流感季節情況嚴峻。因此,ANCHOR 試驗中的事件發生率似乎可能提前於計劃發生。但我很想了解您對進行完整試驗的看法。

  • Is it based on generating robust data across two geographies, two seasons or anything you're seeing from the event rates point of view in the ongoing trial? And should we expect an interim disclosure in March or after March or not?

    這是基於在兩個地理位置、兩個季節中產生可靠的數據,還是基於您在正在進行的試驗中從事件發生率的角度所看到的任何東西?我們是否應該預期在3月份或3月份之後看到中期揭露報告?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • This is Dean. I do think your point about the relatively severe season, especially for many of us in the Northeast for the flu demonstrates how important this month could be. We have completed enrollment in the Northern Hemisphere. I want to emphasize, as I said in the prepared, we are in parallel recruiting in the southern hemisphere. This is an event-driven trial. I want to have the right trial size.

    這是迪恩。我同意你關於今年流感季相對嚴重的觀點,尤其對我們東北地區的許多人來說,這表明這個月有多重要。北半球的招生工作已經完成。我想強調的是,正如我在準備稿中所說,我們正在南半球同步進行招募。這是一項事件驅動型試驗。我想要合適的試用裝。

  • I want the powering of assumptions. But most importantly, I need to make sure that I have strong data throughout a series of sub-populations that will be important for the future label. So at this time, we have not spoken to communication plans following IA, but we're excited about this first-in-class once-per-season strain-agnostic antiviral agent, which I think will have increasing need as the years go by.

    我想要的是假設的力量。但最重要的是,我需要確保我擁有一系列亞群體的可靠數據,這對未來的標籤標註至關重要。因此,目前我們還沒有討論過 IA 之後的溝通計劃,但我們對這種首創的、每季一次、不針對特定病毒株的抗病毒藥物感到興奮,我認為隨著時間的推移,它的需求會越來越大。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    阿卡什‧特瓦里,傑富瑞集團。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Are there any plans to explore sac-TMT in a first-line NSCLC setting in PD-1 low expressing patients or head-to-head against the KEYNOTE-189 regimen given some of the emerging data you're seeing out of China. I'm kind of curious why your TROP2 development strategy seems to be relatively conservative versus what AstraZeneca and Daiichi are exploring, especially if you have a differentiated asset?

    鑑於您從中國看到的一些新數據,是否有計劃在 PD-1 低表達患者的一線 NSCLC 治療中探索 sac-TMT,或將其與 KEYNOTE-189 方案進行頭對頭比較?我很好奇,為什麼你們的 TROP2 開發策略似乎比阿斯特捷利康和第一三共正在探索的策略要保守一些,尤其是在你們擁有差異化資產的情況下?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • Thank you very much for that question. So as we've said repeatedly, we think this is a workhorse ADC. We also think that -- I look at the HER2 field and I sit there and I go, you just change the linker and the payload and all of a sudden, you have very different readouts from an antibody drug conjugate.

    非常感謝您的提問。正如我們反覆強調的那樣,我們認為這是一款主力ADC。我們也認為——我觀察 HER2 領域,然後我坐在那裡想,你只需改變連接子和有效載荷,突然之間,你就可以從抗體藥物偶聯物中獲得非常不同的讀數。

  • And so we think sac-TMT has a potential to be best-in-class TROP2 directed ADCs. What I would say when you talk about the ambition, I mean, we have 16 Phase III studies, 11 that we view are first-in-class, the other 5 are differentiated.

    因此我們認為 sac-TMT 有潛力成為一流的 TROP2 標靶 ADC。談到我們的雄心壯志,我的意思是,我們有 16 項 III 期研究,其中 11 項我們認為是同類首創,另外 5 項是差異化研究。

  • So I think we're very ambitious with our sac-TMT program. In relationship -- to the specific question, in relationship to non-small cell lung cancer and breast cancer, we think that we have differentiated approaches to others. But most important, we also have it in tissue types and tumor types where we are hoping to be first. So I would challenge a little bit the characterization that we do not have a robust and ambitious program. We have 16 Phase III studies.

    所以我認為我們對 sac-TMT 專案抱有非常遠大的抱負。就具體問題而言,就非小細胞肺癌和乳癌而言,我們認為我們採取的方法與其他方法有所不同。但最重要的是,我們也在組織類型和腫瘤類型中取得了成功,我們希望在這些方面成為第一名。因此,我對「我們沒有一個強大而雄心勃勃的計劃」這種說法持保留態度。我們有16項III期臨床試驗。

  • Operator

    Operator

  • Alex Hammond, Wolfe Research.

    Alex Hammond,Wolfe Research。

  • Alexandria Hammond - Equity Analyst

    Alexandria Hammond - Equity Analyst

  • So consensus currently anticipates KEYTRUDA's US LOE to occur in '28. However, Merck's SEC filings suggest potential for two additional patents that expire in '29. So I guess, how should we model the IP run rate for KEYTRUDA? And how should we think about the timing associated with QLEX's ramp prior to KEYTRUDA's IV biosimilar introduction?

    因此,目前普遍預期 KEYTRUDA 的美國上市將於 2028 年發生。然而,默克公司向美國證券交易委員會提交的文件顯示,該公司還有兩項專利將於 2029 年到期。那麼,我們應該如何對 KEYTRUDA 的 IP 運作率進行建模呢?在 KEYTRUDA 的靜脈注射生物相似藥上市之前,我們該如何看待 QLEX 的上市時間表?

  • Robert Davis - Chairman and CEO

    Robert Davis - Chairman and CEO

  • Yes. Thanks for the question. As you look at the intellectual property situation for KEYTRUDA, there was -- when the original invention was filed for approval with the patent office, there were actually four patents that made up the patent estate that was the original innovation. One of those is the compound patent, which expires December of 2028. Two of those, one, a method of making patent actually is extended out to May of 2029. And the second one, a method of use patent goes out to November of 2029.

    是的。謝謝你的提問。從 KEYTRUDA 的智慧財產權情況來看,當最初的發明向專利局提交批准申請時,實際上有四項專利構成了最初的創新專利組合。其中一項是化合物專利,將於 2028 年 12 月到期。其中兩項,一項是專利申請方法,其有效期實際上延長至 2029 年 5 月。第二項是用途專利,有效期限至 2029 年 11 月。

  • And so as we looked at this, initially, we were conservative in our assumptions and always based off the compound patent, always though with the intent that we would defend the entire patent estate. I think what has evolved over time is that as case law has emerged, our confidence that we will be able to defend those additional two patents has grown. And thus, there is a potential that you're going to see protection actually make it through either May or November of 2029.

    因此,在研究這個問題時,我們最初採取了保守的假設,始終以化合物專利為基礎,但始終抱著捍衛整個專利體系的意圖。我認為隨著時間的推移,隨著判例法的出現,我們對能夠捍衛這兩項新增專利的信心也越來越強。因此,保護措施有可能持續到 2029 年 5 月或 11 月。

  • For planning purposes, we continue to assume 2028 because I think that's a conservative assumption. We'll have to see where it goes. And I would also remind you that we do face the IRA as of the beginning of 2029.

    出於規劃目的,我們繼續假設 2028 年,因為我認為這是一個保守的假設。我們得看看事情會如何發展。我還要提醒各位,從 2029 年初開始,我們將面臨 IRA 的挑戰。

  • As we think about the QLEX adoption, we continue to think we're going to see 30% to 40% adopted as you get out to 2028, and we will drive that as high as we can. And as you know, we have priced this to drive for the adoption from KEYTRUDA IV to QLEX. So that will continue. That strategy is underway. And frankly, whether it's '28 or '29 does not change the strategy we're following.

    當我們考慮 QLEX 的普及率時,我們仍然認為到 2028 年,其普及率將達到 30% 到 40%,我們將盡最大努力提高這一比例。如您所知,我們制定此價格是為了推動從 KEYTRUDA IV 過渡到 QLEX。所以這種情況還會持續下去。該策略正在實施中。坦白說,無論是 '28 還是 '29,都不會改變我們正在遵循的策略。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    Evan Seigerman,BMO資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • I want to touch on the HIV data that you were discussing. Can you just contextualize the importance of a dual regimen versus the standard of care bictegravir or Biktarvy? And kind of what's the feedback in more broadly unmet need for a dual regimen versus the standard of care triple.

    我想談談您剛才提到的愛滋病毒數據。能否具體說明雙聯療法相對於標準療法比克替拉韋(Bictegravir 或 Biktarvy)的重要性?那麼,對於雙聯療法與標準三聯療法相比,更廣泛的未滿足需求方面,反饋如何呢?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • Yes. So thank you very much for that question. So as you highlight, we're really excited about islatravir because we really think it's a next-generation nucleoside analog. So leverage is a unique mechanism of translocation inhibition that gives it high potency and a high degree of resistance. In relationship to two drugs and three drugs, there have been always a need for different options.

    是的。非常感謝你的提問。正如您所強調的,我們對伊斯拉曲韋感到非常興奮,因為我們真的認為它是下一代核苷類似物。因此,槓桿作用是一種獨特的轉位抑制機制,使其具有高效力和高度抗性。對於兩種藥物和三種藥物,始終需要不同的治療方案。

  • You see it already, there is a two-drug regimen out there in relationship to three drugs, and there have been considerable switching that occurs in this patient population just as a general rule. So the ability to send a different sort of repertoire of compounds, especially if you can spare the integrase would be potentially very important. For some people, that's often viewed in light of metabolic and long-term issues with HIV treatment.

    你已經看到了,目前存在兩種藥物聯合治療方案,而另一種方案是三種藥物聯合治療方案,而且一般來說,這類患者群體中已經出現了相當多的藥物轉換。因此,能夠發送不同類型的化合物庫,尤其是在可以騰出整合酶的情況下,可能非常重要。對某些人來說,這通常與 HIV 治療引起的代謝問題和長期問題有關。

  • So I think there will be an excitement of having a two-drug combo without an INSTI backbone. Equally important, I just want to make sure is we're driving a two-drug regimen for the first Q-weekly offering, and we have one with our partner, Gilead, and we have another one with (technical difficulty). So I think all of those, that two drug for daily, but also that two drug for weekly is something -- there's no weekly three drug or two drugs.

    所以我認為,沒有 INSTI 骨架的雙藥組合療法會令人興奮。同樣重要的是,我想確認一下,我們首個每週一次的給藥方案是否採用雙藥聯合療法,我們與合作夥伴吉利德公司合作開發了一種方案,還有另一種方案是與…合作開發的。(技術難題)所以我認為所有這些,包括每天服用兩種藥物,以及每週服用兩種藥物——沒有每週服用三種藥物或兩種藥物的情況。

  • So we think there will be an important opportunity for patients to experience a Q-weekly option. And finally, we have a Q-monthly oral prep. There is no other Q-monthly oral prep. Although it's not islatravir, it's a related compound, which is MK-8527.

    因此,我們認為患者將有機會體驗每週一次的治療方案。最後,我們還有每月一次的口腔準備。沒有其他每月一次的口腔準備方法。雖然它不是伊斯拉曲韋,但它是相關的化合物,即 MK-8527。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • A bigger picture question for Rob. But in 2025, Merck achieved the sales guidance it provided to start the year and you dealt with the GARDASIL pressures all year long. But in any year for any company, there will be some challenges. So this is likely to be more of the rule rather than the exception. And Merck has some growth products, too. So in what might be a typical year, Merck grew minimally. And in 2026, you are again looking for minimal top line growth with the KEYTRUDA LOE still a couple of years off.

    對羅布來說,這是一個更宏觀的問題。但在 2025 年,默克實現了年初給出的銷售目標,而你則全年都在應對加衛苗帶來的壓力。但任何公司在任何一年都會面臨一些挑戰。所以這很可能是常態而非例外。默克公司也有一些成長型產品。因此,在可能屬於尋常的一年裡,默克公司成長甚微。到 2026 年,由於 KEYTRUDA LOE 還有幾年時間才能實現,你們預計營收成長將再次達到最低水準。

  • So the question is, is this what we should expect from Merck going forward, a company that grows modestly in good times and significantly pressured in less good times? Or can Merck achieve sustainable, strong sales growth in the decade ahead despite what will be inevitable challenges?

    所以問題是,我們是否應該對默克公司未來的發展抱持這樣的預期:在經濟情勢好的時候成長緩慢,而在經濟狀況不好的時候則面臨巨大的壓力?或者,默克公司能否在未來十年克服​​不可避免的挑戰,實現可持續的強勁銷售成長?

  • Robert Davis - Chairman and CEO

    Robert Davis - Chairman and CEO

  • Yes. No, Steve, I appreciate the question. I would just reemphasize as we look forward, and I think what you're hearing in our confidence and why we think over time, we will be a strong growing company. So I'm not sure I agree with your characterization that we will be a modest growing company in every year or less depending on what happens. That's, I think, taking one year out of context.

    是的。不,史蒂夫,我很感謝你的提問。我想再次強調,展望未來,我認為你們能從我們的自信中感受到,隨著時間的推移,我們將成為一家強勁成長的公司。所以我不太同意你對我們公司每年或更短時間內保持溫和成長的描述,這取決於未來情況的發展。我認為,這是斷章取義,只專注在一年的情況。

  • But if you look over the longer term, that $70 billion we have of potential is significant when you think that that is -- as you look at it, it's more than double what KEYTRUDA will be at its consensus peak in '28 of $35 billion. And importantly, $20 billion higher than where we were and driven by probably the broadest and widest pipeline we've had in years.

    但從長遠來看,我們擁有的 700 億美元潛力是巨大的,因為——正如你所看到的,這比 KEYTRUDA 在 2028 年達到的共識高峰 350 億美元還要多一倍。更重要的是,比我們之前的水準高出 200 億美元,這得益於我們多年來可能擁有的最廣泛、最充足的專案儲備。

  • So our belief in our ability to have sustainable growth once we get post the LOE is as high as it's ever been, and we're not done. We have early-stage pipeline assets that we believe we'll be reading out in the next two years and will allow us to continue to bring some of those assets into this period, plus additional business development. And as you know, none of this includes the Animal Health business, which we expect to more than double out to the mid-2030s as well as the base of KEYTRUDA over time.

    因此,我們對在 LOE 結束後實現永續成長的能力充滿信心,而且我們還沒有完成目標。我們擁有一些處於早期階段的管線資產,我們相信在未來兩年內我們將公佈這些資產的進展,這將使我們能夠繼續把其中一些資產帶入這段時期,並進行額外的業務開發。如您所知,以上所有數據均不包括動物保健業務,我們預計到 2030 年代中期,該業務規模將翻一番以上,同時也將隨著時間的推移成為 KEYTRUDA 的基礎。

  • So I think that's important to understand. And the other thing I'd highlight, of the $70 billion, we're going to derisk substantially all of that by the time we get to the end of 2027. So you'll know the portfolio that's going to drive our growth into the next decade by the time you get out to 2027. And that's, I think, also important as people start to want clarity on the long-term future.

    所以我認為理解這一點很重要。還有一點我想強調的是,在這 700 億美元中,到 2027 年底,我們將大幅降低所有風險。這樣,到 2027 年,你就會知道哪些投資組合將推動我們在未來十年成長。我認為這一點也很重要,因為人們開始希望了解長遠的未來。

  • The last thing I would just add, if you look at 2025 as an example, what we saw in the quarter is really a strong growth profile. And as you look forward, if you adjust for the LOE period we had that we've noted with JANUVIA, with DIFICID, with BRIDION plus LAGEVRIO and Koselugo, we actually are giving guidance of growth in, I think, the 4% to 7% or roughly 5% to 8% range over time, which actually is pretty strong growth. And I think that is more the focus. What is the sustainable strategic growth of those assets long term, not what are the onetime nonstrategic LOEs we're facing this year.

    最後我想補充一點,以 2025 年為例,我們在本季看到的確實是一個強勁的成長前景。展望未來,如果我們考慮到我們之前提到的捷諾維亞、迪菲西德、百利安以及拉格維裡奧和科塞盧戈的研發週期,我們實際上給出的增長預期是,我認為,隨著時間的推移,增長幅度將在 4% 到 7% 或大約 5% 到 8% 的範圍內,這實際上是一個相當強勁的增長。我認為這才是重點。這些資產的長期永續策略成長是什麼,而不是我們今年面臨的一次性非策略性支出是什麼。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    James Shin,德意志銀行。

  • James Shin - Research Analyst

    James Shin - Research Analyst

  • One for Dean. On CADENCE at ACC presentation, can you help level set what we should and should not expect to learn? Also, any color on which potential endpoints may be explored in the Phase III for CpcPH due to HFpEF?

    給迪恩的。在 ACC 的 CADENCE 演講中,您能否幫助我們明確一下我們應該學到什麼,不應該學到什麼?此外,對於因 HFpEF 引起的 CpcPH,III 期臨床試驗中可能會探討哪些潛在終點指標?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • You broke up for a little bit there. So I hope that I answer your questions. I think we'll provide the data from that Phase II. There's a primary endpoint, but there's also important secondary endpoints that will also be provided. In relationship to what you've just asked in terms of a future Phase III that we've discussed, we're in the middle of those discussions with the FDA. And I think just as a general sort of statement, generally, we'll have to think about things like functional activity.

    你們中間有段時間分手了。希望我的回答能解答您的問題。我認為我們會提供第二階段的數據。除了主要終點外,還將提供重要的次要終點。關於您剛才提到的我們討論過的未來 III 期臨床試驗,我們正在與 FDA 進行討論。我認為總的來說,我們必須考慮諸如功能性活動之類的事情。

  • You often have clinical events that will be important. There'll be biomarkers. But it will be very important to align with the FDA because in this patient population, which should be an orphan indication patient population, we'll have to level set as to how one thinks about the outcomes and the primary, secondary endpoints.

    您經常會遇到一些重要的臨床事件。會有生物標誌物。但與 FDA 保持一致非常重要,因為在這個患者群體(應該是一個罕見疾病適應症患者群體)中,我們必須統一對結果以及主要和次要終點的看法。

  • But we're eager to provide that data at ACC, and we're continuing to have discussions with the FDA as we define essentially a new population that we're going to target with this drug. And so some of the questions you had in terms of the endpoints are things that are important discussions right now.

    但我們渴望在 ACC 上提供這些數據,並且我們正在繼續與 FDA 進行討論,以確定我們將使用這種藥物治療的新人群。所以,你提出的一些關於終點的問題,正是目前需要認真討論的重要議題。

  • Operator

    Operator

  • Carter Gould, Cantor.

    卡特·古爾德,坎托爾。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • Another one for Dean. I recognize on your TL1A, the near-term focus is on ATLAS UC. At the same time, we're seeing the entrenched IL-23 players step up sort of all sorts of combinations as well as multispecifics rapidly, intensify their efforts with pretty sizable partnerships. So again, recognizing ATLAS UC is a near-term focus, but how does Merck think about the importance and speed it may need to pursue combinations on the back of those data later this year?

    又給迪恩一個。我注意到,在您的 TL1A 中,近期重點是 ATLAS U​​C。同時,我們看到根深蒂固的 IL-23 玩家正在迅速地推出各種組合以及多用途產品,並透過相當大的合作關係加大投入。因此,儘管 ATLAS U​​C 被認為是近期重點,但默克公司如何看待今年稍後根據這些數據進行聯合治療的重要性和速度?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • Yes. So I love your question just so that we all level set. Essentially, in this field, TNF and IL-23 has dominated. And the big question is whether there's a third node or a third class, which is TL1A. And our ambition is to be the first and best-in-class TL1A. We're studying it in six diseases.

    是的。所以,我很喜歡你的問題,這樣我們就能明確彼此的立場了。從本質上講,在這個領域,TNF 和 IL-23 佔據主導地位。而最大的問題是是否存在第三個節點或第三類,即 TL1A。我們的目標是成為首款也是同類最佳的TL1A。我們正在研究它對六種疾病的影響。

  • But as you highlight, it is the ulcerative colitis and the Crohn's disease that's coming up very quickly. If those are successful, like in every immunology indication, the question will become patient populations, other diseases. But then people will start talking about combinability. They'll talk about combinability in terms of two separate antibodies. They'll talk about bi-specifics. And increasingly, they'll talk about orals.

    但正如你所指出的,潰瘍性結腸炎和克隆氏症正在迅速蔓延。如果這些療法成功,就像在所有免疫學適應症中一樣,問題將變成患者群體、其他疾病。但隨後人們就會開始討論組合性。他們會從兩種不同抗體的角度來討論組合性。他們會討論特異性抗體。而且,他們會越來越多地談論口試。

  • And I can assure you that, that concept of we intend to be first and best, but also that we have a robust plan for being next is well in line. But that's probably something that I don't want to say on a public call at this time.

    我可以向你們保證,我們力爭成為第一、最好的,而且我們也制定了強有力的計劃來成為後來者,這種理念是完全一致的。但這可能是我現在不想在公開電話會議上說的話。

  • Operator

    Operator

  • Geoff Meacham, Citi.

    傑夫‧米查姆,花旗銀行。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Another one on WINREVAIR. So you're about to hit two years on the market. Can you guys speak to trends on duration of therapy or maybe real-world safety tolerability? And if anything is different versus Phase III? And then beyond CADENCE, how are you guys thinking about related pulmonology indications just where the mechanism may have an impact?

    溫瑞瓦特(WINREVAIR)上還有另一家。所以你即將進入市場兩年了。各位能否談談治療持續時間的趨勢,或實際應用中的安全性和耐受性?與第三階段相比,有什麼不同之處嗎?除了 CADENCE 之外,你們如何看待相關的肺病學適應症,以及這個機制可能在哪些方面產生影響?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • So I'll start. There were a lot of questions from a scientific standpoint. But I just want to emphasize that WINREVAIR is reshaping the standard of care in PAH. It's doing it because it is a differentiated pathway and a molecule. All the other drugs, you would look at this and you would say they are classic vasodilators.

    那我先來。從科學角度來看,有很多問題。但我只想強調,WINREVAIR 正在重塑 PAH 的治療標準。之所以會這樣,是因為它是一種差異化的路徑和分子。其他所有藥物,你看看這些,都會說它們是典型的血管擴張劑。

  • This is a drug that gets to the underlying biology through the genetics. And the way that I would actually begin to think about WINREVAIR and what WINREVAIR may be doing to right heart failure and PAH is similar to what Merck showed for ACE inhibitors back in the day in relationship to left heart failure.

    這是一種透過基因層面作用於潛在生物學機制的藥物。而我真正開始思考 WINREVAIR 以及 WINREVAIR 可能對右心衰竭和 PAH 產生的作用的方式,與默克公司當年對 ACE 抑制劑在左心衰竭方面所表現出的作用類似。

  • So when you ask me that question, I'm sitting there like I think we are already reshaping the standard of care. I would imagine guidelines will be coming out and will be shaped by that clinical data. In relationship to adverse effects and long-term treatment, I actually just came from a tour in Texas of sites, and they're quite bullish on not only the drug, but also the sustainability and the concept that all of a sudden, they began in their minds talking about blunting cardiac remodeling. So that's with this.

    所以當你問我這個問題時,我坐在那裡想,我認為我們已經在重塑護理標準了。我想應該會推出相關指南,並且這些指南會根據臨床數據制定。關於不良反應和長期治療,我剛結束了在德克薩斯州的考察之旅,他們不僅對這種藥物,而且對它的可持續性和概念都非常樂觀,他們突然開始在腦海中討論抑制心臟重塑的問題。事情就是這樣。

  • We are advancing in relationship to heart failure as the previous question did in CADENCE. But I love your question because much of it is focused on what is the stress on the right heart. And as you point out, there could be pulmonary indications where you get pulmonary hypertension that we have to think carefully about where and when to use this drug. But there are investigators who have posed that question to us.

    我們正在推進與心臟衰竭相關的研究,就像 CADENCE 中的前一個問題一樣。但我喜歡你的問題,因為它主要關注的是右心所承受的壓力。正如你所指出的,有些情況下可能會出現肺動脈高壓,因此我們必須仔細考慮在什麼情況下以及何時使用這種藥物。但有些調查人員已經向我們提出了這個問題。

  • And they also pose the question that when you look at PAH, there is different patient populations, but quite a number of them have connective tissue disorders. So they immediately go, connective tissue disorders are also related to pulmonary fibrosis and other pulmonary disease. So those are discussions and those are things that people are exploring as we speak, and we will see some of those data, and that will guide our decisions in the future.

    他們也提出了這樣一個問題:當你觀察 PAH 時,你會發現患者群體各不相同,但其中相當一部分人患有結締組織疾病。所以他們立刻想到,結締組織疾病也與肺纖維化和其他肺部疾病有關。所以這些都是我們正在討論和探索的問題,我們將看到其中的一些數據,這些數據將引導我們未來的決策。

  • Robert Davis - Chairman and CEO

    Robert Davis - Chairman and CEO

  • And maybe, Jeff, I would just add, if you look at where we are today, and just to give you a sense of the breadth, we have over 110,000 prescriptions, which have been dispensed. There's now over 9,100 patients who have started therapy. And if you look, our overall compliance continues to be quite high. We are seeing a slow increase in the rates of discontinuation. But frankly, it's generally in line with what or slightly better than what we're seeing with other PAH products. And so we feel good about where that is.

    傑夫,我還要補充一點,看看我們今天的情況,為了讓你了解一下規模,我們已經發放了超過 11 萬張處方。目前已有超過9,100名患者開始接受治療。而且,如果你仔細觀察,你會發現我們的整體合規率仍然相當高。我們看到停藥率正在緩慢上升。但坦白說,它總體上與其他多環芳烴產品的情況一致,或者略好一些。所以我們對目前的情況感到滿意。

  • And then on the safety side, we continue to be very confident in the safety profile, and it's consistent with label. And I'd also point out now, as you've seen across what we've reported with HYPERION as well as with ZENITH and then looking back at STELLAR and then what we've also brought forward is some of the long-term data from SOTERIA, across all of those, the safety profile is very consistent. And so we feel very good about where we are with compliance, where we are with safety. Everything is tracking as you would expect.

    在安全性方面,我們仍然對產品的安全性非常有信心,並且與標籤所示一致。而且我還想指出,正如你們在我們報導的 HYPERION 和 ZENITH,以及回顧 STELLAR,還有我們提出的 SOTERIA 的一些長期數據中所看到的,所有這些項目的安全性都非常一致。因此,我們對自身在合規性和安全性方面的狀況感到非常滿意。一切都在預期中進行。

  • Operator

    Operator

  • Umer Raffat, Evercore.

    Umer Raffat,Evercore。

  • Umer Raffat - Analyst

    Umer Raffat - Analyst

  • Rob, I'm trying to balance today the fact that you're laying out a $70 billion non-risk-adjusted revenue opportunity for the current pipeline as well as all the prior track record of sort of $5 billion revenue opportunities acquired for about $10 billion or under versus the large deal that's been in the press lately. I'm just trying to balance it all.

    羅布,我今天想權衡一下,一方面你提出了一個價值 700 億美元的非風險調整收入機會,用於當前的項目儲備,另一方面,你之前以大約 100 億美元或更少的價格獲得了價值 50 億美元的收入機會,這與最近媒體報道的那筆大交易形成了鮮明對比。我只是想平衡好這一切。

  • Robert Davis - Chairman and CEO

    Robert Davis - Chairman and CEO

  • Yes. Umer, I appreciate the question. Obviously, we don't comment or speculate on market rumors. If you look at our BD strategy and where we are, I would start by just pointing to the fact that as you highlight, with the $70 billion of commercial potential we've highlighted and the fact that, that's $20 billion better than where we were a year ago. I am very proud of the progress we're making, and it's why my confidence is so high.

    是的。烏默,感謝你的提問。顯然,我們不會對市場傳聞發表評論或進行猜測。如果你看看我們的業務拓展策略以及我們所處的位置,我會先指出,正如你所強調的,我們已經強調了700億美元的商業潛力,而且這比一年前的情況好轉了200億美元。我為我們所取得的進展感到非常自豪,這也是我信心十足的原因。

  • And obviously, we still have more time to continue to do more, both in terms of advancing our early-stage pipeline, which we think can have impact in this area as well as adding additional assets through BD, which we've indicated we are continuing to be very interested in doing.

    顯然,我們還有更多時間繼續做更多的事情,無論是推進我們的早期研發管線(我們認為這可以對該領域產生影響),還是透過業務拓展增加其他資產(我們已經表示我們對此仍然非常感興趣)。

  • If you look at where we're focused, it's where we've always said, which is for opportunities where we see significant scientific advancement, addressing an unmet need aligned with our strategy and importantly, where we see value creation. Where we see those things align, we move, but we've always done it with discipline. You've seen that across all the deals we've done, and we will continue to do so as we move forward.

    如果你看看我們關注的重點,就會發現它和我們一直以來所說的一樣,那就是那些我們看到重大科學進步、滿足未滿足的需求(符合我們的策略)以及更重要的是,我們看到價值創造的機會。我們會選擇那些符合這些條件的地方,但我們一直以來都秉持著嚴謹的態度行事。您在我們完成的所有交易中都看到了這一點,而且我們將繼續這樣做,向前邁進。

  • Obviously, looking in the area up to $15 billion is our sweet spot. But as we've also highlighted, for the right scientific deal, we'd go bigger, but using the same methods, the same discipline, the same approach we've used across everything we've done to date.

    顯然,150億美元以下的價位是我們最理想的目標價位。但正如我們也強調的那樣,對於合適的科學交易,我們會擴大規模,但會採用相同的方法、相同的紀律、相同的方法,就像我們迄今為止所做的一切一樣。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    克里斯‧肖特,摩根大通。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Just on MK-3000, it's obviously a new mechanism, but also listed as one of your key near-term products for derisking that $70 billion. Can you just help set stage a little bit in terms of what gives you such confidence in this asset and how large of an opportunity you see, assuming we get some positive data this year?

    就 MK-3000 而言,它顯然是一種新機制,但也被列為降低 700 億美元風險的關鍵近期產品之一。您能否稍微介紹一下,是什麼讓您對這項資產如此有信心,以及假設我們今年獲得一些積極的數據,您認為它蘊藏著多大的機會?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • I'll let others speak about how big the opportunity is, but diabetic macular edema and wet age-related, I'm sorry, AMD and DME are really important indications and have important molecules out there. They are all based on vascular endothelial growth factor. This is the first pathway that is based on the genetics of vascular stability in the eye, and we have the first agonistic antibody towards that.

    我會讓其他人來談論這個機會有多大,但是糖尿病性黃斑水腫和濕性老年黃斑部病變(抱歉,是 AMD 和 DME)是非常重要的適應症,並且有重要的分子可供研究。它們都基於血管內皮生長因子。這是第一個基於眼部血管穩定性遺傳學的通路,我們擁有第一個針對該通路的激動性抗體。

  • So we're really interested in seeing whether this mechanism will work because it will be the first non-vascular endothelial growth factor that's going to be driving to the indications of age-related macular degeneration and diabetic macular edema.

    因此,我們非常想看看這種機制是否有效,因為它將是第一個用於治療老年黃斑部病變和糖尿病黃斑水腫的非血管內皮生長因子。

  • Just historically, up to 40% individuals have sub-optimal response to VEGFs. We think that that's an important opportunity for us. But I also want to just make sure that people recognize that even in patients who have responses to vascular endothelial growth factor, MK-3000 could also be part of the repertoire with which they're treated as well.

    從歷史數據來看,高達 40% 的人對 VEGF 的反應不佳。我們認為這對我們來說是一個重要的機會。但我也想確保人們認識到,即使對於對血管內皮生長因子有反應的患者,MK-3000 也可以成為他們治療方案的一部分。

  • Robert Davis - Chairman and CEO

    Robert Davis - Chairman and CEO

  • And maybe just to add, Chris, to some thoughts here on market potential. As you know, if you look at what you see with diabetic macular edema, there is about 1.6 million people with DME today in the United States. It's the leading cause of vision loss due to diabetes. And I'd add, you've got with wet AMD, an additional 1.5 million patients in the United States. So if you look across the total of that market, that's about a $15 billion market. And as Dean just pointed out, 30% to 40% of patients are only partially or not responsive at all to anti-VEGF therapy.

    克里斯,或許我還要補充一點關於市場潛力的想法。如您所知,如果您了解糖尿病性黃斑水腫的情況,您會發現目前美國約有 160 萬人患有糖尿病性黃斑水腫。它是導致糖尿病患者視力喪失的主要原因。我還要補充一點,在美國,濕性老年黃斑部病變患者還有 150 萬人。所以,如果縱觀整個市場,那大約是一個價值 150 億美元的市場。正如迪恩剛才指出的那樣,30% 到 40% 的患者對 VEGF 抗治療只有部分反應或完全沒有反應。

  • So the opportunity to bring a new mechanism into this space is quite meaningful. And the only thing I'd add is while you're speaking about MK-3000 in DME now, we are also studying it in wet AMD in RVO. And importantly, we have MK-8748, which is the novel bispecific antibody that agonizes Tie2 while inhibiting VEGF.

    因此,將一種新機制引入這個領域的機會意義非凡。我唯一要補充的是,既然您現在在談論 DME 中的 MK-3000,我們也正在研究它在 RVO 中的濕性 AMD 中的應用。更重要的是,我們擁有 MK-8748,這是一種新型雙特異性抗體,它能激動 Tie2,同時抑制 VEGF。

  • We're very excited about that. It's really the combination of both of those assets that why we believe this is a greater than $5 billion opportunity as we look forward. And I would say it's probably one of the more underappreciated areas, I think, from the Street and what this really can be.

    我們對此感到非常興奮。正是這兩項資產的結合,讓我們相信展望未來,這將是一個超過 50 億美元的機會。我認為,從這條街的角度來看,這可能是最被低估的地區之一,它真正能發揮的作用還沒有被充分認識。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. We're going to try and squeeze in one more question, please, Shirley?

    偉大的。雪莉,我們再擠出一個問題好嗎?

  • Operator

    Operator

  • Daina Graybosch, Leerink Partners.

    Daina Graybosch,Leerink Partners。

  • Daina Graybosch - Analyst

    Daina Graybosch - Analyst

  • I'll finish with the sac-TMT one. I wonder if you could update us on your biomarker strategy given a TROP2 ADC competitor recently announced they're changing some primary endpoints of Phase IIIs to narrow on TROP2 expressers. I know you guys are cooking something and will we see that in any of the Phase IIIs?

    最後我來說說sac-TMT那個。鑑於 TROP2 ADC 的競爭對手最近宣布他們正在改變 III 期臨床試驗的一些主要終點,以縮小 TROP2 表達人群的範圍,我想知道您能否向我們介紹一下您的生物標記策略。我知道你們正在醞釀一些東西,我們會在三期臨床試驗中看到嗎?

  • Dean Li - Executive Vice President and President

    Dean Li - Executive Vice President and President

  • Yes. I'll just kind of answered the question the way that I answered it a few years ago, which is, we think that sac-TMT has an ability to be best-in-class, but it's also important to put it in the right tumor types and to have the right strategy in those tumor types. There will be tumor types where we do not believe that a biomarker will be needed, but we also believe that there are places where that biomarker will be needed, especially if you look at how good the comparator you have to go against.

    是的。我還是會像幾年前那樣回答這個問題,那就是,我們認為 sac-TMT 有潛力成為同類最佳,但將其用於正確的腫瘤類型,並在這些腫瘤類型中採取正確的策略也很重要。有些腫瘤類型我們認為不需要生物標記物,但我們也認為有些情況下需要生物標誌物,尤其是在你考慮到與之比較的比較對像有多好的情況下。

  • So a lot of it is context dependent on the tumor, but also what other treatments are there and how high of a bar you have to beat that comparator.

    所以很多時候取決於腫瘤的具體情況,但也取決於還有哪些其他治療方法,以及你需要達到多高的治療標準才能超越之前的同類療法。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thank you, Daina, and thank you all for your time and attention this morning. If you have any follow-ups, please reach out to the IR team. Take care.

    偉大的。謝謝你,黛娜,也謝謝大家今天早上抽出時間關注。如有任何後續問題,請聯絡投資者關係團隊。小心。