默克藥廠 (MRK) 2026 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 AI 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 Merck & Company, Inc., Rahway, New Jersey, USA second quarter sales and earnings conference call. (Operator Instructions) This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin.

    感謝您耐心等候。歡迎參加美國新澤西州拉威市的默克公司(Merck & Company, Inc., Rahway, New Jersey, USA)第二季銷售與盈餘電話會議。(接線員指示)本通話將被錄音。如您有任何異議,您可於此時中斷連線。現在我想把電話交給投資人關係資深副總裁 Peter Dannenbaum 先生。先生,您可以開始。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Thank you, Shirley, and good morning, everyone. Welcome to the second quarter 2026 conference call for Merck & Company, Incorporated, 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 Li, President of Research Labs.

    謝謝您,Shirley,各位早安。歡迎參加美國新澤西州拉威市的默克公司(Merck & Company, Incorporated, Rahway, New Jersey, USA)2026 年第二季電話會議。今天出席並發言的有董事長兼執行長 Rob Davis;財務長 Caroline Litchfield;以及研究實驗室總裁 Dean Li 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. 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 2025 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 & Company, Inc., Rahway, New Jersey, USA, undertakes no obligation to publicly update any forward-looking statements.

    在開始之前,我想指出,我們的 GAAP 業績中包含若干項目,例如與併購相關的費用、重組成本以及其他特定項目;我們已將這些項目自非 GAAP 業績中排除。新聞稿中提供了調節表。我也要提醒各位,我們今天所做的部分陳述,可能構成 1995 年《美國私人證券訴訟改革法》安全港條款所定義的前瞻性陳述。此類陳述係基於本公司管理層目前的信念,並受重大風險與不確定性影響。若我們的基本假設被證明不正確或不確定性成真,實際結果可能與前瞻性陳述所述有重大差異。我們向 SEC 提交的文件(包括 2025 年 10-K 的第 1A 項)列示了若干風險因素與警示性陳述,可能導致公司實際結果與我們今早任何前瞻性陳述所預測者有重大差異。默克公司(Merck & Company, Inc., Rahway, New Jersey, USA)不承擔公開更新任何前瞻性陳述之義務。

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

    在今天的電話會議中,我們的講者預先準備的發言將搭配投影片簡報。這些投影片、盈餘新聞稿、今天的預備講稿以及我們向 SEC 提交的文件,均已發布於本公司網站的投資人關係專區。接下來,我想把電話交給 Rob。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Peter. Good morning, and thank you for joining today's call. I remain very pleased with the substantial progress we're making across our business driven by strong execution, growing contributions from new product launches, and the continued advancement of the next wave of innovation from our pipeline.

    謝謝你,Peter。各位早安,感謝各位參加今天的電話會議。我對我們在整體業務上取得的重大進展仍感到非常滿意,這些進展來自強勁的執行力、新產品上市帶來的日益增加貢獻,以及我們研發管線中下一波創新持續推進。

  • Earlier this year, we provided insight into greater than $70 billion of commercial opportunity we have from over 20 new products that we expect will transform our portfolio. And in many cases, the practice of medicine, as well as fuel growth well into the next decade. We also outlined a series of clinical milestones that represent key events to substantially de-risk this opportunity. Since then, we've made meaningful advancements against that objective, including several important proof points that have occurred earlier than expected.

    今年稍早,我們分享了超過 700 億美元的商業機會洞見,該機會來自我們預期將改變公司產品組合的 20 多項新產品;在許多情況下,這些產品也將改變臨床醫療實務,並推動成長延伸至下一個十年。我們也概述了一系列臨床里程碑,這些里程碑是大幅降低該機會風險的關鍵事件。自那之後,我們在達成該目標方面取得了實質進展,其中包括數個重要的驗證成果,且發生時間早於預期。

  • This progress further bolsters my high confidence in the future of our company and our ability to create long-term value for patients and shareholders.

    這些進展進一步強化了我對公司未來以及我們為病患與股東創造長期價值能力的高度信心。

  • Turning to our second quarter results, we delivered revenue of $16.6 billion, reflecting continued strength across oncology and animal health, as well as increasing contributions from our recent launches. Importantly, while we're delivering for patients today, we're also making substantial investments in the next generation of innovative medicines and vaccines.

    回到第二季業績,我們實現營收 166 億美元,反映腫瘤與動物保健持續強勁,以及近期上市產品貢獻增加。重要的是,在我們今日為病患提供治療的同時,也正大幅投資於下一代創新藥物與疫苗。

  • We remain confident in our outlook for the remainder of the year, which Caroline will discuss in more detail in a moment. We also achieved several important clinical and regulatory milestones. In cardiometabolic, the FDA approved LIPFENDRA, the first and only oral PCSK9 inhibitor to help reduce LDL cholesterol in adults with hypercholesterolemia, along with diet and exercise.

    我們對今年剩餘期間的展望仍具信心,Caroline 稍後將更詳細說明。我們也達成了數個重要的臨床與法規里程碑。在心腎代謝領域,FDA 核准 LIPFENDRA,這是首個且唯一的口服 PCSK9 抑制劑,可在配合飲食與運動下,協助降低高膽固醇血症成人的 LDL 膽固醇。

  • We're pleased to have worked with the FDA through the Commissioner's National Priority Voucher process to bring this important new treatment option to patients on an accelerated basis. We look forward to providing broad access for patients to help address elevated LDL-C, a major modifiable risk factor for cardiovascular disease. In oncology, we received several approvals that underscore the ongoing impact of KEYTRUDA and the enduring strength of our oncology portfolio.

    我們很高興能透過 FDA 署長的「國家優先審查憑證」(Commissioner's National Priority Voucher)流程合作,以加速方式將這項重要的新治療選擇帶給病患。我們期待為病患提供廣泛可近性,以協助處理 LDL-C 升高——這是心血管疾病一項主要且可調整的風險因子。在腫瘤領域,我們獲得多項核准,凸顯 KEYTRUDA 持續的影響力,以及我們腫瘤產品組合的長期強韌性。

  • At ASCO, we presented encouraging data that further demonstrate the durability of KEYTRUDA, and at our investor event, we highlighted advances for a number of promising candidates across our pipeline. This included the first positive top-line results from our expansive Phase 3 global clinical development program for SAC-TMT, our TROP2-directed antibody-drug conjugate in certain patients with advanced or recurrent endometrial cancer.

    在 ASCO 上,我們發表了令人鼓舞的數據,進一步證明 KEYTRUDA 療效的持久性;在投資人活動中,我們也重點介紹了研發管線中多項具前景候選藥物的進展。其中包括 SAC-TMT(我們的 TROP2 標的抗體藥物複合體)在特定晚期或復發性子宮內膜癌病患中的大型第 3 期全球臨床開發計畫,首次取得正向的主要(top-line)結果。

  • In immunology, we announced positive Phase 3 top-line induction results for tulisokibart for certain patients with ulcerative colitis and are starting to see the first of numerous additional trial readouts, reinforcing our confidence in the potential of this program.

    在免疫學方面,我們宣布 tulisokibart 針對特定潰瘍性結腸炎病患的第 3 期主要(top-line)誘導期結果為正向,並開始看到多項額外試驗讀出中的第一批結果,進一步強化我們對此計畫潛力的信心。

  • And at the AIDS 2026 Congress last week, we shared compelling data from our broad HIV pipeline, including islatravir in combination with lenacapavir, which has the potential to be the first oral once-weekly HIV treatment for virologically suppressed adults. We are excited to be returning to the HIV field with an array of important therapies, including the recent launch of IDVYNSO.

    而在上週的 AIDS 2026 大會上,我們分享了來自廣泛 HIV 研發管線的具說服力數據,其中包括 islatravir 與 lenacapavir 的合併療法,該療法有望成為首個針對病毒學抑制成人、每週一次的口服 HIV 治療。我們很高興能以一系列重要療法重返 HIV 領域,其中包括近期上市的 IDVYNSO。

  • Ahead of the meeting, we also announced initial access plans for MK-8527, our investigational. Oral HIV-1 PrEP candidate now in Phase 3 studies, underscoring our commitment to help enable broad and sustainable access to this candidate upon its potential approval. We also continue to augment our portfolio through disciplined business development. During the quarter, we completed the acquisition of Terns Pharmaceuticals, adding MK-4208, a novel potentially best-in-class therapy for certain patients with chronic myeloid leukemia.

    在會議前,我們也公布了 MK-8527 的初步可近性計畫;MK-8527 為我們的研究中口服 HIV-1 PrEP 候選藥物,目前已進入第 3 期研究,凸顯我們致力於在其潛在獲批後,協助實現廣泛且可持續的可近性。我們也持續透過嚴謹的業務發展來強化產品組合。本季我們完成對 Terns Pharmaceuticals 的收購,新增 MK-4208——一項新穎、可能同級最佳(best-in-class)的療法,適用於特定慢性骨髓性白血病病患。

  • This transaction strengthens our hematology pipeline, adds another promising late stage growth opportunity, and reflects our continued focus on pursuing science-driven business development that can benefit patients and enhance long-term shareholder value.

    此交易強化了我們的血液腫瘤研發管線,新增另一項具前景的後期成長機會,並反映我們持續聚焦於以科學為驅動的業務發展,為病患帶來效益並提升股東長期價值。

  • This quarter marks my fifth year as CEO, and as I reflect on the commitments our leadership team made in 2021, our strategy was clear. Maximize the transformative potential of KEYTRUDA, expand, deepen, and extend our leadership in oncology, bring forward new growth drivers across additional therapeutic areas, and advance Merck's mission of using the power of leading-edge science to save and improve lives around the world.

    本季是我擔任執行長的第五年。回顧我們領導團隊在 2021 年所做的承諾,我們的策略很清楚:最大化 KEYTRUDA 的變革性潛力;擴大、深化並延伸我們在腫瘤領域的領導地位;在其他治療領域帶來新的成長動能;並推進默克的使命——運用前沿科學的力量,在全球拯救並改善生命。

  • Today, I'm proud that we are successfully executing on that strategy. Each year, we're making important progress in building a stronger foundation for our future. We're broadening and diversifying our pipeline, advancing multiple potential blockbuster opportunities, and achieving clinical, regulatory, and commercial milestones that will benefit patients and enhance our long-term growth trajectory.

    今天,我很自豪我們正成功落實這項策略。每一年,我們都在為未來建立更強健的基礎方面取得重要進展。我們正在擴大並多元化研發管線,推進多項潛在重磅(blockbuster)機會,並達成臨床、法規與商業里程碑,這些都將造福病患並提升我們的長期成長軌跡。

  • I believe Merck is substantially stronger, more diversified, and better positioned for sustainable growth than it was just five years ago, while more work remains. I'm increasingly confident in Merck's future, particularly with the rapid pace of clinical and regulatory events now occurring.

    我相信,相較於五年前,默克已顯著更強大、更多元,且在可持續成長方面具備更佳定位,儘管仍有許多工作要做。隨著臨床與法規事件正以快速節奏發生,我對默克的未來愈發有信心。

  • This confidence is grounded in the strength of our science, our disciplined approach to capital allocation, including business development, and the dedication of our colleagues around the world who work every day to deliver for patients.

    這份信心奠基於我們科學實力的強勁、我們在資本配置(包括業務發展)上的嚴謹做法,以及全球同仁每天致力於為病患交付成果的投入與奉獻。

  • I want to extend a special word of thanks to our global team for this substantial progress. And for their commitment and execution on behalf of patients, shareholders, and all of our stakeholders. And now I'll turn the call over to Caroline.

    我想特別向我們的全球團隊致謝,感謝大家促成這些重大進展;也感謝大家為病患、股東以及所有利害關係人所展現的承諾與執行力。接下來我把電話交給 Caroline。

  • Caroline Litchfield - Executive Vice President, Chief Financial Officer

    Caroline Litchfield - Executive Vice President, Chief Financial Officer

  • Thank you, Rob. Good morning. We delivered growth in the quarter, led by continued strength in oncology and animal health, along with increasing contributions from our diverse and compelling new products across an array of therapeutic areas.

    謝謝你,Rob。各位早安。本季我們實現成長,主要由腫瘤與動物保健的持續強勁所帶動,同時我們在多個治療領域中多元且具吸引力的新產品也帶來日益增加的貢獻。

  • Our strong commercial and operational execution continuous to drive near-term performance while we invest in our outstanding pipeline to create long-term value for patients, customers, and shareholders.

    我們強勁的商業與營運執行力持續推動短期表現,同時我們投資於卓越的研發管線,為病患、客戶與股東創造長期價值。

  • Now turning to our second quarter results. Total company revenues were $16.6 billion, an increase of 5%, or 4% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis.

    接著說明第二季業績。公司總營收為 166 億美元,成長 5%;若排除匯率影響,成長為 4%。以下的營收評論將以排除匯率(ex-exchange)基礎說明。

  • In oncology, sales of the KEYTRUDA family of products, which includes KEYTRUDA and KEYTRUDA QLEX, increased 4% to $8.4 billion, with global growth driven by strong uptake in earlier-stage cancers and continued robust demand from metastatic indications.

    在腫瘤領域,KEYTRUDA 產品家族(包括 KEYTRUDA 與 KEYTRUDA QLEX)銷售額成長 4% 至 84 億美元;全球成長主要由早期癌症的強勁採用,以及轉移性適應症持續旺盛的需求所帶動。

  • Strong utilization in tumors that primarily affect women, including breast and cervical cancers, and increased use of KEYTRUDA in combination with Padcev in locally advanced or metastatic urothelial cancer, were key contributors to growth. Sales of KEYTRUDA QLEX were $463 million. We have seen physician and patient adoption increase since the permanent J-code was established in April.

    在主要影響女性的腫瘤(包括乳癌與子宮頸癌)中的強勁使用率,以及 KEYTRUDA 與 Padcev 聯合用於局部晚期或轉移性尿路上皮癌的使用增加,是成長的關鍵貢獻因素。KEYTRUDA QLEX 銷售額為 4.63 億美元。自 4 月建立永久 J-code 以來,我們看到醫師與病患的採用度提升。

  • As expected, early use has been predominantly in patients who are either on monotherapy or in combination with an oral agent. We remain confident in the trajectory of KEYTRUDA QLEX adoption.

    如預期,早期使用主要集中在接受單藥治療的病患,或與口服藥物合併使用的病患。我們對 KEYTRUDA QLEX 的採用趨勢仍具信心。

  • Our broader oncology portfolio delivered another quarter of strong growth. WELIREG sales increased 67% to $271 million, driven by continued uptake from international launches and increased use in certain US patients with previously treated advanced renal cell carcinoma. We are excited that certain patients with earlier stage renal cell carcinoma may benefit from adjuvant. Treatment with WELIREG following the recent FDA approval of LITESPARK-022.

    我們更廣泛的腫瘤產品組合在本季再度實現強勁成長。WELIREG 銷售額成長 67% 至 2.71 億美元,主要受惠於國際上市持續帶動的採用增加,以及在美國部分既往接受治療之晚期腎細胞癌患者中的使用增加。我們很振奮,某些較早期腎細胞癌患者可能可從輔助治療中受益。WELIREG 在近期 FDA 核准 LITESPARK-022 後可用於治療。

  • In vaccines and infectious diseases, GARDASIL sales were $1.2 billion, an increase of 3%. Sales in international markets grew 6%, while the US was roughly flat, as lower demand and timing of CDC purchases was largely offset by price.

    在疫苗與感染性疾病方面,GARDASIL 銷售額為 12 億美元,成長 3%。國際市場銷售成長 6%,而美國市場大致持平,因需求較低及 CDC 採購時點的影響大致被價格因素所抵銷。

  • In pneumococcal, CAPVAXIVE sales were $184 million, an increase of 40%. Growth was primarily driven by uptake from ongoing launches in certain international markets, as well as higher demand in the US.

    在肺炎鏈球菌領域,CAPVAXIVE 銷售額為 1.84 億美元,成長 40%。成長主要由部分國際市場持續上市帶動的採用增加,以及美國需求提升所驅動。

  • In HIV, we are pleased to have launched IDVYNSO, our once daily oral two-drug single tablet regimen of doravirine and islatravir for certain virologically suppressed adults. We have seen encouraging early progress on access and reimbursement and look forward to broadening access over time.

    在 HIV 領域,我們很高興推出 IDVYNSO,這是我們針對部分病毒學已受抑制成人的每日一次口服雙藥單錠療法,包含 doravirine 與 islatravir。我們在可近性與給付/報銷方面已看到令人鼓舞的早期進展,並期待隨時間推進擴大可近性。

  • In cardiometabolic and respiratory, WINREVAIR sales were $588 million, an increase of 75%, reflecting continued strong demand from adults with pulmonary arterial hypertension. In the US, we saw further progress with more than 1800 new patients having received a prescription and an increase in the proportion of patients whose background therapies do not include a prostacyclin.

    在心代謝與呼吸領域,WINREVAIR 銷售額為 5.88 億美元,成長 75%,反映成人肺動脈高壓患者需求持續強勁。在美國,我們看到進一步進展:超過 1,800 名新患者已取得處方,且背景治療中不包含前列環素(prostacyclin)的患者占比上升。

  • Outside the US, we continue to progress with ongoing launches. OHTUVAYRE sales were $204 million, reflecting continued prescription demand from patients with COPD, as well as the benefit from the timing of specialty pharmacy purchases.

    在美國以外地區,我們持續推進各地上市。OHTUVAYRE 銷售額為 2.04 億美元,反映 COPD 患者處方需求持續,以及專科藥局採購時點帶來的效益。

  • Our animal health business delivered another quarter of solid growth with sales increasing 5%. Livestock sales grew 6%, driven by higher demand for ruminants and poultry products. Companion animal sales increased 5% due to new product launches. I will now walk you through the remainder of the P&L, and my comments will be on a non-GAAP basis.

    我們的動物保健事業本季再度交出穩健成長,銷售額成長 5%。畜牧業務銷售成長 6%,主要由反芻動物與家禽產品需求提升所帶動。伴侶動物銷售成長 5%,受新產品上市推動。接下來我將帶各位看損益表其餘部分,我的評論將以非 GAAP 基礎為準。

  • Gross margin was 81.1%, a decrease of 1.1 percentage points, primarily due to higher inventory reserves. Operating expenses increased to $12.6 billion. There was a $5.7 billion charge for the acquisition of Terns Pharmaceuticals in the quarter, compared with a $200 million business development charge a year ago.

    毛利率為 81.1%,下降 1.1 個百分點,主要因存貨準備金提高。營業費用增加至 126 億美元。本季因收購 Terns Pharmaceuticals 認列 57 億美元費用,相較之下,去年同期為 2 億美元的業務開發費用。

  • Excluding these charges, operating expenses grew 7%, reflecting increased investments in support of our launches, as well as our robust early and late Phase pipeline. Partially offset by benefits from our multi-year optimization effort and recognition of a portion of the external funding for sac-TMT development.

    排除上述費用後,營業費用成長 7%,反映我們為支持產品上市所增加的投資,以及我們強勁的早期與後期臨床管線。部分被我們多年期優化計畫帶來的效益,以及 sac-TMT 開發之外部資金部分認列所抵銷。

  • Other expense increased to $290 million, primarily reflecting financing costs related to recent business development transactions. Our tax provision was $882 million. As a result of the non-tax deductible one-time charge for Terns, our tax rate was 160.3%. Taken together, we reported a loss of $0.13 per share, which includes a one-time charge of $2.31 per share from the acquisition of Terns.

    其他費用增加至 2.90 億美元,主要反映近期業務開發交易相關的融資成本。我們的所得稅費用為 8.82 億美元。由於 Terns 的一次性費用不可抵稅,我們的稅率為 160.3%。綜合而言,我們每股虧損 0.13 美元,其中包含因收購 Terns 產生的一次性每股 2.31 美元費用。

  • Now turning to our 2026 non-GAAP guidance. We have raised and narrowed our full year revenue guidance range to be between $66.3 billion and $67.3 billion, representing growth of 2% to 4%, including a positive impact from foreign exchange of approximately 1 percentage point using mid-July rates.

    接著說明我們 2026 年非 GAAP 指引。我們上調並收斂全年營收指引區間至 663 億至 673 億美元,代表成長 2% 至 4%,其中包含依 7 月中旬匯率估算之外匯約 1 個百分點的正面影響。

  • Gross margin is now assumed to be approximately 81%, reflecting higher inventory reserves. Operating expenses are expected to be between $42 billion and $42.7 billion. This range includes $5.8 billion for the upfront charge for Terns and investment to advance MK-4208.

    目前假設毛利率約為 81%,反映存貨準備金提高。預期營業費用介於 420 億至 427 億美元。此區間包含 Terns 的 58 億美元一次性前期費用,以及推進 MK-4208 的投資。

  • This guidance does not assume additional significant potential business development transactions. Other expense, which now includes the financing costs for Terns, is expected to be approximately $1.4 billion. We now expect a full year tax rate between 35% and 36%, which reflects the non-tax deductible one-time charge for Terns.

    本指引未假設額外重大潛在業務開發交易。其他費用(目前包含 Terns 的融資成本)預期約為 14 億美元。我們目前預期全年稅率介於 35% 至 36%,反映 Terns 不可抵稅的一次性費用。

  • We assume approximately 2.48 billion shares outstanding. Taken together, we expect EPS of $2.66 to $2.76, with a midpoint of $2.71, including a positive impact from foreign exchange of approximately $0.15 using mid-July rates. This range also includes an upfront charge of $2.31 per share related to the acquisition of Terns, as well as approximately $0.12 per share of ongoing costs to advance MK-4208 and finance the transaction.

    我們假設流通在外股數約 24.8 億股。綜合而言,我們預期 EPS 為 2.66 至 2.76 美元,中位數為 2.71 美元,其中包含依 7 月中旬匯率估算之外匯約 0.15 美元的正面影響。此區間亦包含與收購 Terns 相關的一次性每股 2.31 美元前期費用,以及約每股 0.12 美元用於推進 MK-4208 與交易融資的持續成本。

  • As you consider your models, there are a few items to keep in mind for the second half of the year. First, for OHTUVAYRE. We remain excited about OHTUVAYRE's strong clinical profile and look forward to achieving its multi-billion dollar commercial potential in the coming years. Third quarter sales will be impacted by the unwind of specialty pharmacy purchases in the second quarter.

    在各位建模時,下半年有幾點需要留意。首先是 OHTUVAYRE。我們仍對 OHTUVAYRE 強勁的臨床特性充滿期待,並期待在未來幾年實現其數十億美元的商業潛力。第三季銷售將受到第二季專科藥局採購回轉(unwind)的影響。

  • We continue to invest behind our sales force and promotion to reach more physicians and patients in the US. We are also working with our specialty pharmacies to improve patient experience. We expect these actions to lead to accelerated growth in 2027.

    我們持續加大對銷售團隊與推廣的投資,以觸及更多美國醫師與患者。我們也正與專科藥局合作改善患者體驗。我們預期這些行動將在 2027 年帶來加速成長。

  • Next, we anticipate that total US KEYTRUDA year-over-year growth will moderate as we increasingly reach peak penetration across several key indications. Additionally, as a reminder, we benefited by approximately $250 million due to the timing of wholesaler purchases in the third quarter of 2025, which will not repeat this year.

    其次,我們預期美國 KEYTRUDA 的年對年成長將趨於放緩,因我們在多個關鍵適應症上逐步接近滲透率高峰。此外,提醒各位,我們在 2025 年第三季因批發商採購時點而受惠約 2.5 億美元,今年不會再出現。

  • For BRIDION, US sales are anticipated to decline at a slower pace than previously expected due to lower-than-anticipated generic competition.

    就 BRIDION 而言,由於學名藥競爭低於先前預期,美國銷售預計將以較先前預期更慢的速度下滑。

  • Finally, other revenue in the second half of 2026 is expected to be significantly higher than the second half of 2025. This increase is primarily due to our revenue hedging program, as well as an expected milestone receipt in the fourth quarter related to an out-license agreement.

    最後,預期 2026 年下半年其他收入將顯著高於 2025 年下半年。此增幅主要來自我們的收入避險計畫,以及預期於第四季收到與一項對外授權(out-license)協議相關的里程碑款。

  • Now turning to capital allocation, where our strategy remains unchanged. We will continue to prioritize investments that support near and long-term growth, including our new product launches and robust pipeline. We remain committed to the dividend, with the goal of increasing it over time.

    接著談資本配置,我們的策略維持不變。我們將持續優先投入支持中長期成長的投資,包括新產品上市與強勁的研發管線。我們仍致力於股利政策,目標是隨時間逐步提高股利。

  • Business development remains a high priority and we maintain the ability within a strong investment grade credit rating to pursue additional science driven value creating transactions. We are on pace for approximately $3 billion in share repurchases this year as previously communicated.

    業務開發仍是高度優先事項;在維持強健投資級信用評等的前提下,我們仍具備能力推動更多以科學為驅動、創造價值的交易。依先前溝通,我們今年的庫藏股回購進度可望達到約 30 億美元。

  • To conclude, as we enter the second half of the year, we remain confident in the outlook of our business supported by global. Demand for our innovative medicines and vaccines, including our many new product launches. The transformation of our portfolio is underway, and we are well positioned to deliver value for patients, customers, and shareholders now and into the future.

    總結而言,進入下半年之際,我們對業務前景仍具信心,並受到全球對我們創新藥品與疫苗(包括多項新產品上市)需求的支持。我們的產品組合轉型正在進行中,且我們已做好準備,現在及未來都能為患者、客戶與股東創造價值。

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

    接下來,我想把電話會議交給 Dean。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Thank you, Caroline. Good morning, everyone. The second quarter was marked by several important regulatory and clinical milestones. Today, I will provide updates in cardiometabolic disease, HIV, infectious disease, immunology, and oncology.

    謝謝你,Caroline。各位早安。第二季出現數項重要的法規與臨床里程碑。今天我將就心代謝疾病、HIV、感染性疾病、免疫學與腫瘤領域提供最新進展。

  • I will conclude with key upcoming milestones as we look toward the second half of 2026. First in cardiometabolic disease. As Rob mentioned, we recently received FDA approval for LIPFENDRA, the first approved oral PCSK9 inhibitor.

    最後,我將在展望 2026 年下半年時,總結即將到來的關鍵里程碑。首先是心代謝疾病。如 Rob 所提,我們近期獲得 FDA 核准 LIPFENDRA,這是首個獲核准的口服 PCSK9 抑制劑。

  • In the CORALreef Lipids trial, LIPFENDRA was shown to be highly effective in lowering LDL cholesterol with up to a 60% reduction when added to a statin. Earlier this year, updated US guidelines on the management of dyslipidemia from the American College of Cardiology and American Heart Association recognized that atherosclerotic cardiovascular disease remains the leading cause of morbidity and mortality and underscored the need for earlier intervention to help reduce lifelong risk from prolonged elevated lipoprotein exposure.

    在 CORALreef Lipids 試驗中,LIPFENDRA 在降低 LDL 膽固醇方面顯示高度療效,與他汀類併用時降幅最高可達 60%。今年稍早,美國心臟學會(American College of Cardiology)與美國心臟協會(American Heart Association)更新的血脂異常管理指引指出,動脈粥樣硬化性心血管疾病(ASCVD)仍是罹病與死亡的首要原因,並強調需要更早介入,以協助降低因長期暴露於升高脂蛋白所造成的終身風險。

  • Guidelines also reestablished and lowered LDL cholesterol treatment goals, including to under 55 milligrams per deciliter for individuals with ASCVD who are at very high risk of ASCVD events.

    指引亦重新確立並下調 LDL 膽固醇治療目標,包括對於 ASCVD 且 ASCVD 事件風險極高者,目標降至每分升 55 毫克以下。

  • The approval of LIPFENDRA is a major milestone in our effort to make PCSK9 inhibition accessible in a convenient daily oral option. As an oral macrocyclic peptide, LIPFENDRA has the potential to extend the reach of this therapeutic approach globally.

    LIPFENDRA 的核准是我們致力於以便利的每日口服選項提升 PCSK9 抑制可近性的一項重大里程碑。作為口服大環胜肽(macrocyclic peptide),LIPFENDRA 有潛力在全球擴大此治療策略的觸及範圍。

  • Additional regulatory reviews are underway in the European Union and China. We are also advancing combination approaches designed to further reduce LDL cholesterol and target additional ASCVD risk factors. Studies are ongoing to support the development of two potential fixed-dose combinations anchored by LIPFENDRA, one with rosuvastatin and another with MK-7262, our oral Lp(a) inhibitor.

    歐盟與中國的其他法規審查正在進行中。我們也在推進組合療法策略,旨在進一步降低 LDL 膽固醇並鎖定其他 ASCVD 風險因子。相關研究正在進行,以支持開發兩種以 LIPFENDRA 為核心的潛在固定劑量複方:一種與 rosuvastatin 併用,另一種與 MK-7262(我們的口服 Lp(a) 抑制劑)併用。

  • Turning to HIV, yesterday we hosted an investor event focused on our HIV program, including new data presented at AIDS 2026. IDVYNSO provides the foundation of what we believe will be a series of novel entries into the field. Our late stage pipeline aims to address unmet needs for those living with or at risk of HIV through innovative oral options including two once-weekly treatment regimens and a monthly oral option for pre-exposure prophylaxis.

    談到 HIV,昨天我們舉辦了一場以我們的 HIV 計畫為主題的投資人活動,包含在 AIDS 2026 上發表的新數據。IDVYNSO 奠定了我們相信將是一系列新穎切入該領域產品的基礎。我們的後期研發管線旨在透過創新的口服選項(包括兩種每週一次的治療方案,以及一種每月一次的口服暴露前預防(PrEP)選項),滿足 HIV 感染者或有感染風險者的未被滿足需求。

  • In collaboration with Gilead, we announced full results of the Phase 3 ISLEND-1 and -2 trials evaluating the investigational oral once-weekly regimen of islatravir and Gilead's lenacapavir. Both studies demonstrated maintenance of virologic suppression in adults living with HIV who switched therapy from a daily standard of care. These results support the potential for ISLEND to become the first approved oral. Once weekly treatment regimen for adults with virologically suppressed HIV.

    我們與吉利德(Gilead)合作,公布了第 3 期 ISLEND-1 與 ISLEND-2 試驗的完整結果,評估研究性每週一次口服方案:islatravir 與吉利德的 lenacapavir。兩項研究皆顯示,已達病毒學抑制的 HIV 成人在由每日標準治療轉換後,仍可維持病毒學抑制。這些結果支持 ISLEND 有潛力成為首個獲核准的每週一次口服治療方案,用於病毒學已抑制的 HIV 成人。

  • Results were also presented from a Phase 2b study evaluating the investigational oral once weekly combination of islatravir and ulonivirine, an internally developed investigational non-nucleoside reverse transcriptase inhibitor in adults with virologically suppressed HIV.

    同時也發表了第 2b 期研究結果,評估研究性每週一次口服組合:islatravir 與 ulonivirine(我們內部研發的研究性非核苷類逆轉錄酶抑制劑),用於病毒學已抑制的 HIV 成人。

  • Based on these results, we plan to advance ISO/ULO into Phase 3 studies for people living with HIV who are previously untreated and those with prior treatment experience. We also continue to evaluate our monthly oral HIV PrEP option, alimatravir in 2 Phase 3 studies anticipated to read out next year. Next, in infectious disease. We are progressing our Phase 3 study of MK-1406, an investigational long-acting strain agnostic antiviral designed to prevent influenza.

    基於這些結果,我們計畫將 ISO/ULO 推進至第 3 期研究,涵蓋先前未治療的 HIV 感染者,以及具有既往治療經驗者。我們也持續評估每月一次口服 HIV PrEP 選項 alimatravir,目前正進行 2 項第 3 期研究,預計明年讀出。接著在感染性疾病方面,我們正推進 MK-1406 的第 3 期研究;MK-1406 為研究性長效、與病毒株無關(strain agnostic)的抗病毒藥物,旨在預防流感。

  • Enrollment was completed in the Southern Hemisphere. Plans are now in place to continue the study through a second northern hemisphere flu season to strengthen our global regulatory submissions. We remain on track for potential approval in 2029. Moving to immunology to tulisokibart became the first anti-TL1a monoclonal antibody to demonstrate positive results in a Phase 3 trial.

    南半球的收案已完成。目前已規劃將研究延續至第二個北半球流感季,以強化我們的全球法規申請。我們仍按計畫推進,目標在 2029 年具備潛在核准的可能。轉到免疫學,tulisokibart 成為首個在第 3 期試驗中展現正面結果的抗 TL1a 單株抗體。

  • In June, we reported on the induction only study of the ATLAS-UC trial in patients with moderately to severely active ulcerative colitis, tulisokibart met the primary endpoint of clinical remission as well as key secondary endpoint with no new safety concerns identified. We look forward to the upcoming readout of the larger induction and maintenance study, which together with the induction only study would form the basis of a regulatory filing and will be presented at an upcoming scientific congress.

    6 月,我們報告了 ATLAS-UC 試驗中僅誘導期(induction only)研究的結果;在中度至重度活動性潰瘍性結腸炎患者中,tulisokibart 達成臨床緩解的主要終點,亦達成關鍵次要終點,且未發現新的安全性疑慮。我們期待即將公布更大型的誘導期與維持期(induction and maintenance)研究讀出;該研究與僅誘導期研究合併,將構成法規申請的基礎,並將於即將到來的科學會議上發表。

  • These findings reinforce the potential of targeting TL1A to help address immunofibrosis, a key driver of disease progression across multiple immune-mediated inflammatory conditions. We have advanced a broad Phase 2 development program to further explore this hypothesis and now have results from two of these studies.

    這些發現進一步強化了以 TL1A 為標的的潛力,可望協助處理免疫纖維化(immunofibrosis)——這是多種免疫介導發炎性疾病進展的關鍵驅動因素。我們已推進一項廣泛的第 2 期開發計畫以進一步驗證此假說,目前已取得其中兩項研究的結果。

  • In SSc-ILD, the study did not meet its primary end point. In Hidradenitis Suppurativa, we are pleased to share that the study met its primary and key secondary endpoints. Results will be shared in due course. Finally, in oncology, KEYTRUDA continues to generate compelling clinical data and regulatory approvals, including in earlier stages of disease.

    在 SSc-ILD 中,研究未達主要終點。在化膿性汗腺炎(Hidradenitis Suppurativa)方面,我們很高興分享該研究達成主要與關鍵次要終點;結果將於適當時機公布。最後在腫瘤學方面,KEYTRUDA 持續產出具說服力的臨床數據與法規核准,包含在更早期的疾病階段。

  • Recently, building on the approval of KEYNOTE-905, the FDA approved an expanded indication for KEYTRUDA and KEYTRUDA QLEX, each with Padcev treatment before and after surgery for adults with muscle invasive bladder cancer based on the data from KEYNOTE-B15, this regimen is now improved regardless of cisplatin eligibility and is the first and only perioperative immunotherapy plus ADC regimen to extend survival for these patients.

    近期,在 KEYNOTE-905 核准的基礎上,FDA 依據 KEYNOTE-B15 的數據,核准擴大 KEYTRUDA 與 KEYTRUDA QLEX 的適應症:兩者各自可與 Padcev 併用,於手術前後治療成人肌層浸潤性膀胱癌。此方案現已不受是否適用順鉑(cisplatin)限制而獲核准,並且是首個且唯一一個可延長此類患者存活期的圍手術期免疫治療加 ADC 方案。

  • We are also pleased that the FDA recently approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for the adjuvant treatment of certain patients with clear cell renal cell carcinoma based on the LITESPARK-022 study. This marks WELIREG's first approval in earlier-stage disease and brings the total number of earlier-stage indications for KEYTRUDA-based regimens to 13.

    我們也很高興 FDA 近期依據 LITESPARK-022 研究,核准 KEYTRUDA 與 KEYTRUDA QLEX 與 WELIREG 併用,用於特定透明細胞腎細胞癌患者的輔助治療(adjuvant treatment)。這是 WELIREG 在較早期疾病中的首次核准,並使以 KEYTRUDA 為基礎的較早期適應症總數達到 13 項。

  • In June, at our ASCO investor event we shared updates across our broad and diverse oncology portfolio. We also highlighted a series of pivotal readouts expected over the next several years. We are now beginning to see the first of those milestones materialize with the announcement of positive Phase 3 results from our global profuse development program evaluating sac-TMT.

    6 月,在我們的 ASCO 投資人活動中,我們分享了涵蓋廣泛且多元腫瘤產品組合的最新進展,也強調未來數年預期將出現的一系列關鍵讀出。我們現在開始看到其中第一批里程碑逐步實現:我們宣布全球 TroFuse 開發計畫中、評估 sac-TMT 的第 3 期試驗取得正面結果。

  • In TroFuse-005, sac-TMT demonstrated statistically significant and clinically meaningful improvement in both overall survival and progression-free survival versus chemotherapy in certain patients with advanced or recurrent endometrial cancer. We plan to apply the National Priority Review Voucher for sac-TMT towards our filing in endometrial cancer.

    在 TroFuse-005 中,sac-TMT 相較於化療,於特定晚期或復發性子宮內膜癌患者中,在總存活期(overall survival)與無惡化存活期(progression-free survival)兩方面皆展現具統計顯著且具臨床意義的改善。我們計畫將國家優先審查憑證(National Priority Review Voucher)用於 sac-TMT 在子宮內膜癌的申請。

  • These results represent the first readout from our global TroFuse program which includes 17 Phase 3 studies. The TroFuse program was intentionally designed to pursue both first-mover opportunities where sac-TMT can establish early leadership and indications in breast and non-small cell lung cancer where we can apply novel development approaches. This global effort continues to be informed by promising results generated by our partner, Kelun from their program evaluating sac-TMT in China.

    這些結果是我們全球 TroFuse 計畫的首次讀出;該計畫包含 17 項第 3 期研究。TroFuse 計畫在設計上刻意同時追求兩類目標:一是 sac-TMT 可建立早期領先地位的「先行者」機會;二是在乳癌與非小細胞肺癌等適應症中,運用新穎的開發策略。這項全球努力也持續參考我們合作夥伴科倫(Kelun)在中國評估 sac-TMT 計畫所產生的令人鼓舞結果。

  • Positive results from the OptiTROP-Lung05 and more recently, OptiTROP-Lung06 further strengthens our confidence in the potential of this differentiated TROP2-directed ADC. In closing, we anticipate a busy second half of the year. with multiple events and milestones, including in cardiometabolic and respiratory, the September 21 PDUFA date for WINREVAIR for the label update based on the Phase 3 HYPERION study, in immunology for tulisokibart, the second readout from the ATLAS-UC trial and the presentation of data from the Phase 2 HS study.

    OptiTROP-Lung05 的正面結果,以及更近期的 OptiTROP-Lung06,進一步強化我們對這款具差異化、以 TROP2 為標的之 ADC 潛力的信心。最後總結,我們預期今年下半年將相當忙碌,將有多項事件與里程碑,包括:在心腎代謝與呼吸領域,WINREVAIR 依據第 3 期 HYPERION 研究進行標籤更新的 PDUFA 日期為 9 月 21 日;在免疫學方面,tulisokibart 將迎來 ATLAS-UC 試驗的第二次讀出,以及第 2 期 HS 研究數據的發表。

  • In ophthalmology, data from the Phase 3 BRUNELLO study of remigromig, also known as MK-3000, our novel Wnt agonist being evaluated in patients with diabetic macular edema.

    在眼科方面,將公布 remigromig(亦稱 MK-3000)的第 3 期 BRUNELLO 研究數據;這是我們新穎的 Wnt 致效劑(Wnt agonist),正在糖尿病黃斑水腫患者中評估。

  • And finally, in oncology, potential approvals for WELIREG plus LENVIMA in advanced renal cell carcinoma and for I-DXd in extensive stage small cell lung cancer and data presentations from across our broad oncology portfolio, including detailed results of the Phase 3 TroFuse-005 study. Please mark your calendars for the evening of Monday, October 26, and where we will host an investor event at the European Society for Medical Oncology in Madrid.

    最後在腫瘤學方面,可能的核准包括:WELIREG 加 LENVIMA 用於晚期腎細胞癌,以及 I-DXd 用於廣泛期小細胞肺癌;同時也將有來自我們廣泛腫瘤產品組合的多項數據發表,包括第 3 期 TroFuse-005 研究的詳細結果。請在行事曆上標記 10 月 26 日(週一)晚間,我們將於馬德里歐洲腫瘤內科學會(European Society for Medical Oncology)期間舉辦投資人活動。

  • I look forward to providing further updates on our progress. And now I will turn the call back to Peter.

    我期待就我們的進展提供更多更新。現在我把電話交回給 Peter。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Thank you, Dean. Shirley, we're now ready to begin Q&A. And we kindly request that analysts limit themselves to one question today so we can get to as many questioners in the time that we have. Thank you.

    謝謝你,Dean。Shirley,我們現在準備開始問答。我們也敬請各位分析師今天每人僅限提一個問題,以便在有限時間內讓更多提問者有機會發問。謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Akash Tewari with Jefferies.

    Jefferies 的 Akash Tewari。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Dean, you [explicitly] stated a biomarker strategy would be the right approach for first-line -- but with sac-TMT, we've seen a signal regardless of PD-L1 expression with the OptiTROP-Lung05 and OptiTROP-Lung06 data, what are the chances we could see a broad sac-TMT pembro trial that goes head-to-head against KEYNOTE-189 and is it fair to say we could see SAC TMT combos with both pembro and a PD-1 VEGF for first-line lung?

    Dean,你先前[明確]表示第一線採用生物標誌物策略會是正確作法——但就 sac-TMT 而言,從 OptiTROP-Lung05 與 OptiTROP-Lung06 的數據來看,不論 PD-L1 表現量似乎都有訊號;我們看到一個廣泛的 sac-TMT 加 pembro 試驗、正面對決 KEYNOTE-189 的機率有多大?另外,是否可以說在第一線肺癌,我們可能會看到 SAC TMT 與 pembro 以及 PD-1+VEGF 兩種組合?

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • My simple answer is yes on all accounts, but I'll just step back a little bit, which is for a -- sac-TMT we've stated, we think it's a cornerstone ADC. I mean it's a TROP-2 ADC, but it has a novel linker and payload. And as described in the prepared remarks, we've sort of split the Phase 3 into 1st mover where we go into indications where we thought we could be first. And actually, what we're hoping is that the [TroFuse-005] and endometrial sort of gives validation to that strategy.

    我簡單的回答是:各方面都是「是」,但我先稍微退一步說明。對於 sac-TMT,我們已表示我們認為它是一個基石型 ADC。它是 TROP-2 ADC,但具有新穎的連接子(linker)與載荷(payload)。如同事先準備的發言所述,我們把第 3 期計畫分成「先行者」部分——也就是進入我們認為可望率先取得地位的適應症。實際上,我們希望 [TroFuse-005] 與子宮內膜癌的結果能驗證這項策略。

  • And as we've noted, we've talked to the administration's FDA, and this will be the 1 that goes for national priority vouchers. In breast and lung, we've said that we need to be differentiated given other TROP-2 ADCs. But as you point out, the Kelun OptiTROP-Lung06 gives us a lot of confidence in the target and to target it across the full spectrum of PD-L1 -- so yes, we are going to rethink KEYNOTE-189, which is KEYTRUDA plus chemo, and now we have sac-TMT as an ADC as a next-gen chemo.

    此外,如我們所提,我們已與主管機關的 FDA 溝通,而這將是用於國家優先審查憑證的那一項。在乳癌與肺癌方面,我們表示鑑於其他 TROP-2 ADC 的存在,我們必須做出差異化。但如你所指出,科倫的 OptiTROP-Lung06 讓我們對該標的很有信心,也相信可在 PD-L1 全光譜範圍內進行標的治療——因此是的,我們將重新思考 KEYNOTE-189(即 KEYTRUDA 加化療),而現在我們有 sac-TMT 這個 ADC,可作為下一代化療。

  • I do think that we're going to be very thoughtful as to the IO agent and when we should use KEYTRUDA and when we should use other agents such as MK-2010, and -- and as you might imagine, we're advancing MK-2010. With that in mind, we are moving quite fast in relationship to initiating trials some that are signal finding some that are dose and scheduling to optimize with novel agents, and we're advancing trials that can go from a Phase 2 to Phase 3 seamlessly.

    我確實認為,我們會非常審慎地思考免疫腫瘤(IO)藥物的選擇,以及何時應使用 KEYTRUDA、何時應使用其他藥物(例如 MK-2010);而且——如你所想像的——我們正在推進 MK-2010。基於此,我們在啟動試驗方面進展相當迅速,其中一些是用於訊號探索(signal finding),一些是用於劑量與給藥時程的研究,以便與新型藥物搭配達到最佳化;同時我們也在推進可從第 2 期無縫銜接至第 3 期的試驗。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Thank you, Akash.

    謝謝你,Akash。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Umar Raffat, Evercore.

    Umar Raffat,Evercore。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • Hi, guys. Thanks for taking my question. Dean, congrats on the HS trial update for the TL1A. I'm just trying to think out loud. To what extent as we go into these new indications is the activity we're seeing for these TL1As beyond what we would have expected from a TNF? I'm sure you can appreciate where I'm coming from on this. Thank you.

    嗨,各位。謝謝讓我提問。Dean,恭喜 TL1A 在 HS 試驗更新的結果。我只是試著把想法說出來:當我們進入這些新的適應症時,我們在這些 TL1A 上看到的活性,在多大程度上是超出我們原本對 TNF 所預期的?我相信你能理解我問題的出發點。謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes, thank you very much. So just to step back a little bit, I think the question is posed and the fact that TL1A is a member of the TNF superfamily. The TNFs have been really important drugs. They have been advanced. There is often problems with combining them because of their safety signal.

    是的,非常感謝。先稍微退一步說明,我想這個問題的背景在於 TL1A 是 TNF 超家族的一員。TNF 類藥物一直是非常重要的藥物,也已經被推進到很成熟的階段;但由於安全性訊號的關係,將它們合併使用時往往會遇到問題。

  • In relationship to what we've seen so far, clearly when you think of immunology, you think of three buckets. You think of GI, you think of derm, and you think of rheumatology. In GI, clearly we're very eager to move forward in ulcerative colitis and Crohn's disease, and we're really eager to see the other half of the UC study. In the derm sort of space, we have it in HS, and I think that's important, as well as we have psoriatic arthritis.

    就我們目前看到的情況而言,談到免疫學,你可以把它分成三個「桶」:腸胃(GI)、皮膚科(derm)以及風濕免疫(rheumatology)。在 GI 領域,我們顯然非常渴望在潰瘍性結腸炎與克隆氏症上繼續推進,也非常期待看到 UC 研究的另一半數據。在皮膚科領域,我們在 HS 上有資料,我認為這很重要;此外我們也有乾癬性關節炎。

  • I think the positive readout for HS gives us more confidence in the derm sort of possibilities for this drug, and so that's where we're looking at. I still think that within the rheum space, which is, let's say, RA, to some degree of arthritis, we'll have to sort of play that out as the data comes out. But I can just tell you, for example, for rheumatoid arthritis, we have very clear biomarker data suggesting we should go after TL1A. And clearly in something like rheumatoid arthritis, there are animal models in preclinical where you can guesstimate what your activity is. And we have that data that gives us the strength to move forward in rheumatoid arthritis.

    我認為 HS 的正向讀出讓我們對這個藥物在皮膚科領域的可能性更有信心,因此這也是我們正在關注的方向。我仍然認為,在風濕領域——例如類風濕性關節炎(RA),以及某種程度的其他關節炎——我們需要隨著數據出來再逐步推演。不過我可以告訴你,例如在類風濕性關節炎方面,我們有非常明確的生物標記(biomarker)數據,顯示我們應該鎖定 TL1A。而且在類風濕性關節炎這類疾病上,臨床前有動物模型可以用來推估可能的活性;我們也有這些數據,讓我們有足夠的把握推進類風濕性關節炎的開發。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great. Thanks, Umer.

    很好。謝謝你,Umer。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Terrence Flynn, Morgan Stanley.

    Terrence Flynn,Morgan Stanley。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Great. Thanks for taking the question. Two-part for me.

    很好,謝謝讓我提問。我有兩個部分。

  • I was just wondering, Dean, if you could help us think about, ahead of the Astra data of ANSA data, what you'd be most interested to see in that data set and implications for your sac-TMT development strategy. And then anything you can say, I know it's a Kelun-Biotech study, but OptiTROP-Lung06, just in terms of control arm performance in that trial. Any comments? Thank you.

    Dean,我想請你幫我們思考一下:在 Astra 的 ANSA 數據出來之前,你最想在那組數據中看到什麼?以及這對你們 sac-TMT 的開發策略有何意涵?另外,關於 OptiTROP-Lung06——我知道那是科倫生物(Kelun-Biotech)的研究——但就那個試驗的對照組表現而言,你能否評論一下?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. So let me take the last question first. We have a great partner in Kelun. We see very detailed data and we are very comfortable with the data that they've shown us and it gives us great confidence in moving forward. I would just highlight that some of the data that we saw is why we, for example, moved quickly to endometrial.

    好的。我先回答最後一個問題。我們與科倫是很好的合作夥伴。我們能看到非常詳細的數據,對他們向我們展示的資料也非常放心,這讓我們對後續推進充滿信心。我想特別強調的是,我們看到的一些數據,也是我們例如快速推進到子宮內膜癌(endometrial)的原因之一。

  • So we have a lot of confidence in how they run their clinical trials and their data. I forgot the first half again.

    因此,我們對他們執行臨床試驗的方式以及其數據品質都很有信心。我又忘了前半段問題是什麼。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Avanza.

    Avanza。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Avanza. I think the critical thing is, I think the vans are -- I think we're waiting to see what the readout looks like. We're looking to see what it looks like in all comers, what we look like in relationship to biomarker selected. And that will give us some views as to how do we advance ours, the need for a biomarker. You can always have a biomarker, but that doesn't mean that you always need it.

    Avanza。我認為關鍵在於——我想我們正在等待讀出會是什麼樣子。我們會看在所有受試者(all comers)中的表現,也會看在生物標記篩選(biomarker selected)族群中的表現。這將讓我們對如何推進我們自己的項目、以及是否需要生物標記有一些看法。你永遠可以有一個生物標記,但不代表你永遠都需要它。

  • And then the other sort of thing is how we think about advancing it in relationship to combination with an excellent PD-1 like KEYTRUDA or whether or not we should move it forward with an excellent PD-1 VEGF.

    另外一個面向是,我們如何思考推進它與優秀的 PD-1(如 KEYTRUDA)合併使用,或者是否應該與優秀的 PD-1/VEGF 方案一起推進。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great. Thanks, Terrence.

    很好。謝謝你,Terrence。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Michael Yee, UBS.

    Michael Yee,UBS。

  • Michael Yee - Analyst

    Michael Yee - Analyst

  • Great, thank you. Great. On TL1A, 2-part question. You had 1 positive Phase 3 in UC but not a whole lot was said. So how do you think we should think about the profile in ulcerative colitis appreciate in the second studies coming and then it's supposed to be all about fibrosis, but then the SSC study wasn't positive today. So how does that change your thinking around Crohn's and that fibrosis opportunity. Thank you.

    很好,謝謝。關於 TL1A,我有兩個問題。你們在 UC 有一個正向的第 3 期,但提到的不多。我們應該如何看待潰瘍性結腸炎的產品特徵,尤其是接下來第二個研究即將出來?另外,原本大家說重點在纖維化,但今天 SSC 研究並未呈現正向。這會如何改變你們對克隆氏症以及纖維化機會的看法?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. So thank you very much for that question. In terms of the Tulisokibart Study 2, I mean we're very eager to see Study 1 because together, that will be the package that we sent to the FDA. And we are looking forward to that readout as we advanced it.

    是的,非常感謝這個問題。就 Tulisokibart 的 Study 2 而言,我們非常期待看到 Study 1,因為兩者合在一起,將構成我們送交 FDA 的整體資料包。我們也期待在推進過程中看到那個讀出結果。

  • Again, in Crohn's disease, there's a clear signal, not just from us but from others. And it's what do we see in Phase 3. So I think we're very interested in moving those forward. You can look at some of the derm in the rheum indications that I spoke about. They will also have fibrosis component.

    再者,在克隆氏症方面,有明確的訊號,不只是來自我們,也來自其他人;關鍵在於第 3 期會看到什麼。因此我認為我們非常有興趣把這些往前推。你也可以看看我提到的一些皮膚科與風濕免疫適應症;它們同樣會有纖維化的成分。

  • In relationship to SSC ILD. I would just step back. I don't know any anti-cytokine that has worked. So this was a bold move to move that forward. It's a challenging and refractory disease.

    至於 SSC ILD,我想先退一步說:我不知道有任何抗細胞激素(anti-cytokine)的藥物在這裡成功過。因此把它推進是一個大膽的決定;這是一種具挑戰性且難治(refractory)的疾病。

  • We see no safety concerns. But I will tell you that when we publish that data as you might imagine, we will.

    我們沒有看到任何安全性疑慮。但我可以告訴你,當我們發表這些數據時——如你所想像的,我們會發表——

  • I look very carefully at the placebo arm. If I see no progression in the placebo arm, it is an SSc-ILD, but if I have no progression in the placebo arm, the chances that I will be able to show benefit in a treatment arm becomes much more difficult. So I would not throw out the immuno fibrosis based on the SSc-ILD study not reading out positive in the specific patient population we recruited.

    我會非常仔細地看安慰劑組(placebo arm)。如果我看到安慰劑組沒有疾病進展——這確實是 SSc-ILD——但如果安慰劑組沒有進展,那麼要在治療組顯示出效益就會變得困難得多。因此,我不會因為這項 SSc-ILD 研究在我們招募的特定病人族群中未呈現正向讀出,就否定免疫纖維化(immuno fibrosis)的機會。

  • Operator

    Operator

  • Geoff Meacham, Citi.

    Geoff Meacham,Citi。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Dean, on the LIPFENDRA launch, I wanted to ask how you guys view the pace of maybe initial access. I wasn't sure what the right reimbursement expectation or if you thought the outcomes trial maybe would be more needed as a commercial tipping point.

    Dean,關於 LIPFENDRA 的上市,我想問你們如何看待初期取得給付/准入(access)的速度。我不確定合理的報銷(reimbursement)預期應該是什麼,或你們是否認為結果試驗(outcomes trial)可能更需要,才能成為商業上的轉折點。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • So why don't I turn the commercial to Rob, if that's okay? And then I can answer the remaining questions from a scientific standpoint.

    如果可以的話,我先把商業面的問題交給 Rob,然後我再從科學角度回答其餘問題。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yes. Great. Thanks for the question, Jeff. If you look at it overall, I would just say we're very pleased with what we're seeing so far. Obviously, you saw the label.

    好的。很棒,謝謝你的問題,Jeff。整體來看,我只能說我們對目前看到的情況非常滿意。顯然,你也看到了標籤(label)。

  • We have a very clean label, one we feel very good about. And with the fact that we have up to 60% LDL lowering, I think this is going to be a meaningful treatment. We're seeing very high interest from physicians and patients based on the approval announcement and ordering has begun last week, and we expect to be able to have it to pharmacies here shortly.

    我們的標籤非常乾淨,我們對此感覺很好。再加上我們可達到最高 60% 的 LDL 降幅,我認為這將是一個有意義的治療選項。基於核准公告,我們看到醫師與病患的興趣非常高,上週已開始下單(ordering),我們預期很快就能供貨到藥局。

  • As we look at it from an access perspective, overall, we're, I think, in pretty good shape. You remember, we really tried to set this up for broad access in the way we priced it and the way we're going. That said, we do believe it's going to take time to get that access established. So we are expecting to see the pace not be as fast out of the gate. But with long term, continue to expect to see this to be definitely a blockbuster opportunity as we move forward.

    從准入(access)的角度來看,整體而言我認為我們處於相當不錯的狀態。你還記得,我們在定價與推進方式上,確實是以廣泛准入為目標來設計。不過,我們也相信建立這些准入需要時間。因此我們預期一開始的速度不會那麼快。但從長期來看,隨著我們持續推進,我們仍然預期這會是一個明確的重磅(blockbuster)機會。

  • I'll let Dean speak specifically to the broader question from a science perspective.

    我讓 Dean 從科學角度回應更廣泛的問題。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. So one of the thing I do want to highlight is there's often a lot of discussion of this FDA or this administration FDA, I can tell you, in our conversations with this administration's FDA, they wanted to use LIPFENDRA as a cornerstone way to demonstrate what they're trying to do with their priority sort of review. Most of the programs in that priority review only touch one of the sort of the pillars of what they're trying to do. But they were very clear to us they want us to touch all of these pillars. And those pillars is to target public health crisis, an innovative breakthrough, a large unmet need, especially in chronic disease, which is a pillar of this HHS.

    好的。我確實想強調一點:外界常常討論「這個 FDA」或「這個政府任期的 FDA」。我可以告訴你,在我們與本屆政府的 FDA 對話中,他們希望把 LIPFENDRA 作為一個基石案例,用來展示他們所推動的優先審查(priority review)想要達成的目標。多數納入該優先審查的計畫,只觸及他們目標中的某一個支柱;但他們非常清楚地告訴我們,希望我們能涵蓋所有這些支柱。而這些支柱包括:鎖定公共衛生危機、具創新性的突破、龐大的未被滿足需求,特別是在慢性疾病領域——這也是 HHS 的一項支柱。

  • They were very clear they want onshoring and supply chain and resilience in the US, and they were very interested in accessibility in relationship to increasing accessibility. So those five sort of pillars, that's what the FDA and us are racing to do as we launch this important product.

    他們非常明確表示,他們希望在美國推動回流生產(onshoring)、供應鏈與韌性,並且他們也非常關注可近性,尤其是與提升可近性相關的議題。因此,這五大支柱大致上就是 FDA 與我們在推出這項重要產品時,正加速推進的方向。

  • Great.

    很好。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Thanks, Geoff.

    謝謝你,Geoff。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Chris Schott, JP Morgan.

    JP Morgan 的 Chris Schott。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Great. Thanks so much for the question. I guess with the pipeline derisking we've seen over the past year, can we get any directional views or updated color on what you're envisioning Merck's earnings profile could look like as we move through the KEYTRUDA LOE? I know the focus of the company is more on the return to growth as we look out into the early 2030s. But just would be any thoughts on that transition period of earnings could look like over that, let's say, 2028 through early 2030s period. Thanks so much.

    很好。非常感謝這個問題。我想,鑑於我們在過去一年看到的研發管線去風險化(derisking),能否請你們就你們所設想的、在 KEYTRUDA 專利到期(LOE)期間,默克的獲利輪廓可能會是什麼樣子,提供一些方向性的看法或更新的補充說明?我知道公司更聚焦於展望 2030 年代初期的重返成長。但仍想請教,在過渡期的獲利表現可能會如何發展——例如 2028 年到 2030 年代初期這段期間。非常感謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yes, Chris, thanks for the question. As we've said in the past, we feel very good about the progress we're making with the over 20 products we have coming, $70 billion of commercial opportunity, and we've already started to see meaningful clinical derisking happening at a pace faster than we expected as well as good solid launches from the products that have launched.

    是的,Chris,謝謝你的提問。正如我們過去所說,我們對目前的進展感到非常樂觀:我們有超過 20 項即將推出的產品,對應約 700 億美元的商業機會;而且我們已經開始看到有意義的臨床去風險化,以比我們預期更快的速度發生,同時已上市產品的推出表現也相當穩健。

  • So as we sit here today, we feel very good, as I've said in the past, -- we see that as the LOE period is more of a hill than a cliff. Nothing has changed in our view. I do think you're going to see a shallow dip with a fast return back to growth.

    因此,以我們今天所處的位置來看,我們感覺非常好——如我先前所說——我們認為 LOE 期間更像是一座坡(hill),而不是斷崖(cliff)。我們的看法沒有改變。我確實認為你們會看到一個幅度不深的下滑,並且很快回到成長。

  • And candidly, if we look at it on a non-risk-adjusted basis, we still aspire to grow through it. There still is the potential more to do to achieve it, but we're working to get there. So as I sit here today, I feel very good about where we are and the progress we're making. Always more to do, but I feel good about the hand we have right now.

    坦白說,如果以未做風險調整(non-risk-adjusted)的角度來看,我們仍然期望能在這段期間維持成長。要達成這點仍可能需要做更多努力,但我們正朝那個方向推進。所以以我今天的立場來看,我對我們目前的位置與進展感到非常有信心。永遠都有更多可以做的事,但我對我們現在手上的牌感覺很好。

  • Operator

    Operator

  • Great.

    很好。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Thanks, Chris.

    謝謝你,Chris。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    Bernstein 的 Courtney Breen。

  • Courtney Breen - Equity Analyst

    Courtney Breen - Equity Analyst

  • Martine, thanks so much for the question today. Just one on LIPFENDRA, following up on the comments regarding kind of fixed-dose combinations. You highlighted rosuvastatin in your own Lp(a). Particularly with rosuvastatin, I would love to hear a little bit about how you're thinking about which dose you might consider. Is this just for those patients that need further escalation once they've made it to the 40 mg, recognizing there are some more adverse events there?

    Martine,謝謝你今天回答問題。我想問一題關於 LIPFENDRA,延續你們對固定劑量複方(fixed-dose combinations)的評論。你特別提到在你們的 Lp(a) 方案中加入 rosuvastatin。就 rosuvastatin 而言,我很想多聽一些你們如何思考可能會考慮的劑量。這是否主要是針對那些已經用到 40 mg、仍需要進一步加強治療的病人,並且也考量到那個劑量會有一些較多不良事件?

  • And then secondarily, are you looking at kind of continuing other combinations. We've heard GLP-1 combinations with the PCSK9s from peers and wanted to understand if you're still advancing or considering this opportunity. Finally, we haven't seen it yet pop up on TrumpRx. Just wondering kind of when we can expect that access channel to begin to become available? Thank you so much.

    其次,你們是否也在持續評估其他複方?我們聽到同業在談 GLP-1 與 PCSK9 的複方,想了解你們是否仍在推進或考慮這個機會。最後,我們還沒看到它出現在 TrumpRx 上。想請教大概什麼時候可以預期這個通路的可近性開始開放?非常感謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Why don't I let the TrumpRx go to Rob and then I'll take the rest of them?

    TrumpRx 的部分我先請 Rob 回答,其餘我來回覆,好嗎?

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yes, we're excited about the opportunity. And as you know, in our MFN agreement, we did commit to putting LIPFENDRA on TrumpRx. Those plans are underway. We're working on obviously getting the initial launch moving -- and as soon as we get that going, we'll get it on TrumpRx. So more to come on timing there.

    是的,我們對這個機會感到很興奮。如你所知,在我們的 MFN 協議中,我們確實承諾會把 LIPFENDRA 放到 TrumpRx 上。相關計畫正在進行中。我們目前也在推動初始上市的各項工作——一旦啟動後,我們就會把它上架到 TrumpRx。至於時程,後續會再提供更多資訊。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. In relationship to your combination question, thank you very much. I mean right now, we have an oral PCSK9 that was designed based on the learnings of the antibodies, and we have been able to achieve up to 60% reduction in LDL cholesterol. We are hoping that with rosuvastatin, we would provide to be all the doses. But that combination, we think that we could get up to 80%.

    是的。關於你提到的複方問題,非常感謝。就目前而言,我們有一個口服 PCSK9,是基於抗體類藥物的學習所設計,我們已能達到 LDL 膽固醇最高約 60% 的降低。我們希望與 rosuvastatin 搭配時,能涵蓋所有劑量。不過我們認為,這個複方有機會把降幅提高到 80%。

  • I mean, if we could get up to 80% in a combination, that's a good day for medicine. So those are the sort of way that we think about the rosuvastatin for the LP(a), we'll have to see what the LP(a) actually does in relationship to the reduction -- but we are hoping that in a patient who has high LP(a) that our combination will be able to give unprecedented CVOT outcomes in relationship to that.

    我的意思是,如果複方能做到最高 80% 的降低,對醫療來說就是非常好的成果。這就是我們看待 rosuvastatin 與 Lp(a) 的方式;至於 Lp(a) 實際能降低多少,還需要觀察。但我們希望,對於 Lp(a) 偏高的病人,我們的複方能在這方面帶來前所未有的心血管結局試驗(CVOT)結果。

  • In relationship to GLP, we have focused and said that we're focused on oral combinations. And there is clearly the ability to combine GLP and PCSK9. One of the things that we are very thoughtful about is that for the GLPs, you kind of do the step-up sort of dosing -- there's a lot of nausea and vomiting. So we can combine GLP plus PCSK9, but so far, we have not announced that, that's a combination that we're actively doing in the clinical trials website at this point.

    至於 GLP,我們一直強調我們聚焦在口服複方。GLP 與 PCSK9 的確有明確的複方可能性。我們非常審慎的一點是:GLP 類藥物通常需要逐步加量(step-up dosing),而且會有不少噁心與嘔吐。因此我們可以把 GLP 加上 PCSK9,但截至目前,我們尚未宣布這是一個我們正在臨床試驗網站上積極進行的複方項目。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great. Thanks, Courtney.

    很好。謝謝你,Courtney。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    美國銀行的 Jason Gerberry。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Just another LIPFENDRA question. How do you guys think about the opportunity for injectable PCSK9 switch versus is the bulk of the opportunity more in PCSK9 naive patients. And one thing that we've noticed with injectable PCSK9 relative to statins is pretty low use in the primary care setting. So how do you see kind of the availability of now an oral when you say democratize access to sort of adoption dynamics in the primary care setting?

    再問一題關於 LIPFENDRA。你們如何看待從注射型 PCSK9 轉換用藥的機會,相較之下,主要機會是否更多來自於尚未使用過 PCSK9 的病人(PCSK9 naive)?另外,我們注意到注射型 PCSK9 相對於 statin,在基層醫療(primary care)場域的使用率相當低。當你們說要「普及化可近性」(democratize access)時,你們如何看待現在有口服選項後,在基層醫療端的採用動態會如何演變?

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yes. Thanks for the question. As we've said many times, we are not focusing this market on how do we take share from the injectable PCSK9s. If you look today, injectables only reach about 5% or less of the total market. We're sitting today here in the United States with 30 million people receiving lipid-lowering therapies, who are not at their recommended LDL levels and who -- even more who go untreated.

    是的,謝謝你的問題。正如我們多次提到的,我們並不是把這個市場的重點放在如何從注射型 PCSK9 手上搶市占。若看目前的情況,注射型產品僅觸及整體市場約 5% 或更少。在美國,目前有 3,000 萬人正在接受降脂治療,但他們的 LDL 仍未達到建議目標;而且還有更多人根本未接受治療。

  • So the potential here is much bigger. What we are about is market expansion and helping people understand that cardiovascular disease continues to be the number one silent killer in the United States. We now have a drug that reduces LDL, which is one of the leading causes of atherosclerosis, leading to that cardiovascular death, by up to 60% on top of statins and everyone who is at risk should be on one of these medications.

    因此,這裡的潛力大得多。我們要做的是擴大市場,並協助大家理解心血管疾病仍是美國第一大「沉默殺手」。我們現在有一款藥物,能在 statin 基礎上把 LDL(動脈粥樣硬化的主要成因之一、進而導致心血管死亡)再降低最高約 60%;所有有風險的人都應該使用這類藥物之一。

  • So our goal is to expand, build the market, educate the market, and we're doing that with what we're doing with the guidelines. Obviously, this will all take time because there is inertia we're working against. But if we are successful, this frankly, should raise the water for all boats and not be one where we're taking share.

    所以我們的目標是擴大並建立市場、教育市場,而我們也正透過指引(guidelines)相關工作來推動。當然,這些都需要時間,因為我們正在對抗既有的惰性(inertia)。但如果我們成功,坦白說,這應該會讓整體市場「水漲船高」,而不是一個我們去搶市占的故事。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. And in relationship with the inertia, I think like, for example, the American Heart Association, the American College of Cardiology and other important associations realize the inertia. So they specifically changed the guidelines. And for right now, for example, for secondary ASCVD, they actually said the vast majority of that secondary ASCVD should be less than 55. There's another patient population in there that could be less than 70.

    是的。談到這種惰性,我認為例如美國心臟協會(American Heart Association)、美國心臟學會(American College of Cardiology)以及其他重要學會也意識到這點,所以他們特別調整了指引。以目前來說,例如針對次級預防的 ASCVD,他們其實表示其中絕大多數應該要低於 55;另外還有一部分病人族群可以是低於 70。

  • But the vast majority of people with secondary ASCVD should be less than 55, which is consistent with what Europe and other countries do. And in the prepared remarks, I did say that we are not just advancing this with an approval and a launch in the US, but we're under regulatory sort of discussions and review with the European Union as well as China.

    但次級預防 ASCVD 的絕大多數人應該低於 55,這與歐洲及其他國家的做法一致。而在我事先準備的發言中也提到,我們不只是推進在美國的核准與上市,我們也正在與歐盟以及中國進行監管層面的討論與審查。

  • Caroline Litchfield - Executive Vice President, Chief Financial Officer

    Caroline Litchfield - Executive Vice President, Chief Financial Officer

  • And to add to the comments that Rob and Dean have made -- what we've seen thus far is extremely strong feedback from key scientific leaders, understanding the change in the guidelines, understanding what this product can do to help patients.

    另外補充 Rob 和 Dean 的評論——截至目前,我們從關鍵科學領袖那裡收到非常強烈的正面回饋,他們理解指引的改變,也理解這個產品能如何幫助病人。

  • What we need to do is to translate that to the primary care setting. So that will take some time for us to do so. But our sales teams will be focused on ensuring the right education to the primary care setting as well as to patients on the importance of this medicine.

    我們需要做的是把這些轉化到基層醫療場域。因此這會需要一些時間。但我們的業務團隊將專注於確保對基層醫療端以及病人提供正確的教育,讓大家了解這個藥物的重要性。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great. Thanks, Jason.

    很好。謝謝你,Jason。

  • Next question, please.

    請下一題。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • Mohit Bansal, Wells Fargo.

    Wells Fargo 的 Mohit Bansal。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Okay. Thank you very much for taking my question. I have a question regarding the flu drug program, CD388. Can you talk a little bit about what -- like what were the reasons why you decided to add 1 more seasonal northern hemisphere here. And I think the big question here is that was this decision based on any data you have seen? Or is it was just to satisfy with regulatory components rather than any confidence or lack of confidence in the data so far? Thank you.

    好的。非常感謝讓我提問。我有一題關於流感藥物計畫 CD388。你們能否談談為什麼決定在北半球再增加一個季節性流感季?我想這裡最大的問題是:這個決定是基於你們已看到的任何數據嗎?還是只是為了滿足監管要求,而非因為目前數據帶來的信心或缺乏信心?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Thank you very much for that question. So just to highlight, this is a first-in-class once-per-season strain agnostic antiviral that we're doing for the prevention of flu, especially for those people who are at high risk. What we have said all along is that we plan to launch in 2029 and that, at the same time, I needed to do CMC work in relationship to getting it from three shots to two shots.

    非常感謝這個問題。簡單強調一下,這是一款同類首創、每季一次、對病毒株不設限(strain agnostic)的抗病毒藥物,我們用於流感預防,特別是針對高風險族群。我們一直以來所說的是,我們計畫在 2029 年上市;同時,我也需要進行與 CMC 相關的工作,把給藥從三針改為兩針。

  • And so that's the rate-limiting step. I also said that between now and that time, I would do everything to have the most robust label and the robust packages that would allow us to have a broader footprint of sites to support a global registration and allow me to get the right value proposition in ex-US markets, especially something that we have to think in the day and age of MFN.

    因此那就是限制進度的關鍵步驟。我也說過,在現在到那個時間點之間,我會盡一切努力取得最具說服力的標籤(label)與完整的資料套件(packages),讓我們能有更廣泛的試驗中心布局,以支持全球註冊,並讓我在美國以外市場(ex-US)取得正確的價值主張,尤其是在 MFN 的時代背景下,這點必須納入考量。

  • We've also added key secondary endpoint, which is all cause hospitalization, which I think will be critical in that pursuit. And finally, we're collecting data on subgroups and diverse circulating viral strains throughout the world as we do this. I was also very clear that I did not need and would not take an interim. I did not take or saw an interim. I am going to maximize what this molecule can do in the time frame that I need to such that I do nothing to imperil the launch timing of 2029, but that have the most robust label as well as robust real-world evidence that will be important for health authorities.

    我們也新增了一個關鍵的次要終點,也就是全因住院(all cause hospitalization),我認為這對上述目標至關重要。最後,我們在推進過程中也在收集全球不同亞族群以及多樣化流行病毒株的資料。我也非常清楚地表示,我不需要、也不會採用期中分析(interim)。我沒有進行或看到任何期中分析。我會在我需要的時間框架內,最大化這個分子的潛力,確保不會危及 2029 年的上市時程,同時也能取得最具說服力的標籤,以及對衛生主管機關而言重要的強健真實世界證據(real-world evidence)。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Maybe just to summarize all that, there's no change in our confidence nothing we've seen in data. This is all about strength of filing given the fact that we have the time because we do have to do the bridging study that Dean mentioned.

    或許總結一下:我們的信心沒有改變,從資料中也沒有看到任何影響信心的事情。這完全是因為我們有時間(畢竟我們確實需要做 Dean 提到的橋接研究),所以要把申報(filing)的強度做得更扎實。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Thank you, Mohit.

    謝謝你,Mohit。

  • Next question, please.

    下一個問題,謝謝。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    Evan Seigerman,BMO Capital Markets。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Well, thank you so much for taking my question. Kind of a key theme from this call talked about the $70 billion a potential opportunity that you talked about over the next wave of products. What's the biggest risk to achieving this number? And conversely, which programs in the past six months have increased in your confidence? Thank you very much.

    非常感謝讓我提問。本次電話會議的一個關鍵主題,是你們談到下一波產品帶來的 700 億美元潛在機會。達成這個數字最大的風險是什麼?反過來說,過去六個月裡,哪些專案讓你們的信心提升了?非常感謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yes. Thanks for the question. I mean, obviously, I would say, if you look at where we have confidence from what we've seen, it's the fact that we're getting readouts faster than expected. When we talked about this back in January, we had highlighted sac-TMT as well as I-DXd as not having readouts until we got until 2027. We've now seen positive readouts from both.

    是的,謝謝你的問題。我想很明顯地,如果看我們基於所見而有信心的地方,那就是我們拿到讀出(readouts)的速度比預期更快。回到今年一月我們談這件事時,我們曾指出 sac-TMT 以及 I-DXd 要到 2027 年才會有讀出;但現在我們已經看到兩者都有正向讀出。

  • The Tuli has read out faster than we expected. -- everything is moving. So as we sit here today, my confidence is higher than it was in January because we are seeing meaningful derisking. As you recall, at that time, we said there were 10 programs that represented 70% of the $70 billion. And the fact that so many of those are already having positive data.

    Tuli 的讀出也比我們預期更快——一切都在推進。因此就今天而言,我的信心比一月更高,因為我們看到實質的去風險(derisking)。你也記得,當時我們說有 10 個專案代表了 700 億美元中的 70%。而其中這麼多專案已經出現正向數據。

  • So we are clinically derisking them, and we're seeing good launches of those that are underway including an accelerated launch of LIPENDRA by several months. It's hard to frankly point anything I'm worried about. I'm actually feeling quite bullish across the board. Got to knock on wood because things are going well. But credit to our scientific team and the strength of the clinical studies we put in place.

    所以我們正在臨床層面為它們去風險,同時也看到已在進行中的產品有良好的上市表現,包括 LIPENDRA 的上市時程比原先加速了好幾個月。坦白說很難指出我特別擔心什麼;我其實對整體相當看多。當然要敲敲木頭,因為目前進展順利。但這要歸功於我們的科學團隊,以及我們所設計並落地的臨床研究的強度。

  • I feel very good about where we are.

    我對我們目前的狀況感覺非常好。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great. Thanks, Evan.

    很好。謝謝你,Evan。

  • Next question, please.

    下一個問題,謝謝。

  • Operator

    Operator

  • Asad Haider, Goldman Sachs.

    Asad Haider,Goldman Sachs。

  • Asad Haider - Analyst

    Asad Haider - Analyst

  • Great. Thanks for taking the question. Maybe for Dean, on the PD-1 VEGF bispecific program, just any updates on how the pace of that development is progressing and how you're thinking about any potential read across from Summit how many data coming up? And any update on where you are with potential combination trials with the PD-1 VEGF and your ADC assets?

    很好,謝謝讓我提問。可能想請 Dean 談一下 PD-1/VEGF 雙特異性(bispecific)專案:在開發進度的推進速度上有沒有任何更新?以及你們如何看待從 Summit 即將公布的數據中可能獲得的 read-across?另外,關於 PD-1/VEGF 與你們 ADC 資產的潛在聯合試驗(combination trials),目前進展到哪裡?

  • And if I can just have a quick follow-up on TL1A, I know it's been discussed a lot already, but I just appreciate any context or color that you have on where you are with evaluating combination approaches, which is whether field and IBD seems to be moving towards, so how are you thinking about TL1A as a single agent in terms of its competitiveness versus these combo trials that J&J and AbbVie are aggressively are pursuing? Thank you.

    如果可以再快速追問 TL1A:我知道已經討論很多了,但仍希望你能提供一些背景或補充說明,關於你們目前如何評估聯合治療策略;因為整個 IBD 領域似乎正朝向聯合治療發展。那麼在 J&J 與 AbbVie 正積極推進這些 combo trials 的情況下,你們如何看待 TL1A 作為單藥(single agent)的競爭力?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. Thank you very much. In relationship to the PD-1 VEGF sort of story, the way that I think about it is there's a large body of data in relationship to where PD-1 is active, we ourselves have 44 and other people have others. So there's that. There's also a body of evidence of where VEGF is active as well. So you look at that overlap, and that's the place that you would go first.

    是的,非常感謝。就 PD-1/VEGF 這個故事而言,我的思考方式是:關於 PD-1 在哪些腫瘤中有效,已有大量資料;我們自己就有 44(項/資料),其他人也有更多。這是一部分。另一部分是關於 VEGF 在哪些地方有效,也同樣有一套證據。因此你把兩者的重疊區域找出來,那就是你會優先切入的地方。

  • The other sort of thing is that in some of those tumors, we have unique assets that can be combined and that we know are active. So we're going to focus our efforts on PD-1 VEGF in those three sort of then diagrams where we are uniquely able to move forward. We are very interested in following the Summit ASCO data. We think that that's important data for us to follow. But this is our sort of general strategy of PD-1 VEGF in relationship to PD-1, where VEGF is active and where we have unique assets that we know are active that could be combined.

    另外一點是,在其中一些腫瘤裡,我們有可進行聯合的獨特資產,而且我們知道它們是有效的。因此我們會把 PD-1/VEGF 的重點放在那三個類似維恩圖(Venn diagrams)的交集上,也就是我們具備獨特能力能往前推進的地方。我們也非常關注 Summit 在 ASCO 的數據,我們認為那是我們需要追蹤的重要資料。但總體而言,這就是我們對 PD-1/VEGF 的一般策略:聚焦在 PD-1 有效、VEGF 也有效、且我們有已知有效且可聯合的獨特資產的領域。

  • In relationship to combination, you're exactly right. The whole immunology field is trying to think about how it can go to combinations. There has been lots of combinations in the past. TNF and IL-23, there are some evidence that, that would be important. So when we look at TL1A, we're looking to have one of the most effective, if not the most effective anti-cytokine, in whatever the indication we have -- but we think it's also very important to know that the safety profile is extremely clean, which then makes it possible to do combinations.

    至於聯合治療,你說得完全正確。整個免疫學領域都在思考如何走向聯合治療。過去也有很多聯合治療,例如 TNF 與 IL-23;有一些證據顯示那可能很重要。因此當我們看 TL1A 時,我們希望在我們所選的適應症中,打造出最有效、即使不是最有效也要是最有效之一的抗細胞激素(anti-cytokine)藥物——但我們也認為同樣重要的是,安全性特徵必須非常乾淨,這樣才有可能進行聯合治療。

  • The combinations that you would do, for example, in IBD would be different than that of HS, which would be different than what you might do for rheumatoid arthritis. So for each one of those indications, we are looking at the profile of our TL1A and also asking what is the ideal combination for that indication.

    例如在 IBD 會做的聯合治療,會不同於 HS(化膿性汗腺炎),也會不同於你可能在類風濕性關節炎所做的聯合治療。因此針對每一個適應症,我們都在看我們 TL1A 的特徵,同時也在問:對該適應症而言,理想的聯合治療是什麼。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great.

    很好。

  • Thank you, Asad.

    謝謝你,Asad。

  • Next question, please.

    下一個問題,謝謝。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    Luisa Hector,Berenberg。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Hello. Thanks for taking my question. It's another one on LIPFENDRA, please. Just the specific wording on the label, which talks about reduction, but then the cardiovascular outcomes trials have shown to be have shown that you get a reduction in LDL also leads to the reduction in events, specifically for monoclonal antibody PCSK9 inhibitors.

    你好,謝謝讓我提問。我還想再問一題關於 LIPFENDRA。標籤上的具體措辭提到「降低」(reduction),但心血管結局試驗(cardiovascular outcomes trials)已顯示,降低 LDL 也會帶來事件(events)的降低,特別是對單株抗體 PCSK9 抑制劑而言。

  • So just wanted to check whether that wording is a help or a hindrance as you speak to payers and as you go about your promotion? And then still on this CVOT topic. What is the timing of your LIPFENDRA CVOT? And can you comment on how you can ensure that GLP-1 use increasing for weight loss won't impact the result. Would you expect that to be balanced across arms if it does happen? Thank you.

    所以我想確認,當你們與支付方(payers)溝通、以及進行推廣(promotion)時,這樣的措辭是助力還是阻力?另外仍然在 CVOT 這個主題上:你們的 LIPFENDRA CVOT 時程是什麼?以及你們能否評論,如何確保 GLP-1 用於減重的使用增加不會影響結果?如果真的發生,你們是否預期在各試驗組之間會是平衡的?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yes. So let me answer that question. I need to be a little bit careful to talk about what the intention of the FDA of putting note that they put in the label. I think it's going to be extremely helpful. We believe that LIPFENDRA should be added on top of statins.

    是的,我來回答這個問題。我需要稍微謹慎一些,因為要談 FDA 在標籤中加入那段註記的意圖。我認為那會非常有幫助。我們相信 LIPFENDRA 應該是在他汀(statins)治療基礎上加用(added on top of)。

  • So I think that's really important. We also know that the design principle, the design principles of LIPFENDRA, the agency understood was informed by the two antibodies out there.

    所以我認為這點非常重要。我們也知道,LIPFENDRA 的設計原則(design principle / design principles),主管機關理解其參考了市面上的兩款抗體。

  • So I think that it could be helpful from a commercial standpoint, but I think that was the way that we -- that the FDA and ours, the discussion was. I should emphasize that we do not have CLT right now, and we have an ongoing trial that will read out in 2029.

    因此我認為從商業角度可能是有幫助的,而這也是我們——也就是 FDA 與我們——討論時的脈絡。我也要強調,我們目前沒有 CLT,而我們有一項正在進行的試驗,將在 2029 年讀出。

  • Peter Dannenbaum - Vice President of Investor Relations

    Peter Dannenbaum - Vice President of Investor Relations

  • Great. Thank you, Louisa. We're going to end the call there. I know there's a pure call about to start. So thank you all for your time and attention this morning.

    很好,謝謝你,Louisa。我們就到這裡結束電話會議。我知道接下來馬上還有一場電話會議要開始。所以謝謝各位今天早上的時間與關注。

  • We appreciate it. We look forward to catching up at your convenience.

    我們非常感謝。也期待在你方便的時候再與你們交流。

  • Operator

    Operator

  • Thank you. This does conclude today's conference. We thank you for your participation. At this time you may disconnect your lines.

    謝謝。今天的會議到此結束。感謝各位的參與。此時您可以掛斷電話線。