默克藥廠 (MRK) 2025 Q1 法說會逐字稿

內容摘要

默克公司召開了 2025 年第一季電話會議,會議發言人討論了 GAAP 結果、前瞻性聲明和風險因素。該公司報告稱,在腫瘤學和動物保健的推動下,收入取得了強勁增長,並維持了全年預期。提供了有關心臟代謝疾病、愛滋病毒、疫苗和腫瘤學等各種項目的最新進展。

該公司討論了減輕關稅影響的策略,並強調其憑藉強大的產品線的長期前景。他們強調了對創新、業務發展和股東回報的關注。電話會議結束時,邀請大家聯絡投資人關係部門以了解更多問題。

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 quarter one sales and earnings conference call. (Operator Instructions) This call is being recorded. If you have any objections, you may disconnect at this time.

    感謝您的支持。歡迎參加美國新澤西州拉威市默克公司第一季銷售和收益電話會議。(操作員指示)此通話正在錄音。如果您有任何異議,您可以立即斷開連接。

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

    我想把電話轉給投資人關係資深副總裁丹南鮑姆先生。先生,您可以開始了。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thank you, Dustin, and good morning, everyone. Welcome to the first 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 Li, President of Research Labs.

    謝謝你,達斯汀,大家早安。歡迎參加美國新澤西州拉威市默克公司 2025 年第一季電話會議。今天的電話會議發言者將是董事長兼首席執行官羅布·戴維斯 (Rob Davis);卡羅琳·利奇菲爾德 (Caroline Litchfield),首席財務官;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, acquisition-related charges, restructuring costs, and certain other items, that we have excluded from our non-GAAP results.

    在我們開始之前,我想指出的是,我們的 GAAP 結果中的一些項目、收購相關費用、重組成本和某些其他項目已從非 GAAP 結果中排除。

  • 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.

    我們的新聞稿中有和解的內容。我還要提醒您,我們今天所做的一些聲明可能被視為美國 1995 年私人證券訴訟改革法案安全港條款所定義的前瞻性聲明。

  • The 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.

    這些聲明是基於我們公司管理層目前的信念而做出的,並受到重大風險和不確定性的影響。如果我們的基本假設被證明不準確或出現不確定性,實際結果可能與前瞻性陳述中的結果有重大差異。

  • 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.

    我們向美國證券交易委員會 (SEC) 提交的文件(包括 2024 年 10-K 報表中的第 1A 項)確定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結果與我們今天上午做出的任何前瞻性聲明中預測的結果存在重大差異。

  • Merck & Co., Inc., Rahway, New Jersey, USA undertakes no obligation to publicly update any forward-looking statements. 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.

    位於美國新澤西州拉威的默克公司不承擔公開更新任何前瞻性聲明的義務。在今天的電話會議中,我們將以幻燈片演示的形式伴隨發言者的準備好的發言。這些投影片以及收益報告、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均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 over to Rob.

    說完這些,我想把電話轉給 Rob。

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Thank you, Peter. Good morning and thank you for joining today's call. Our company made strong progress to start the year with increasing contributions from our newer commercialized medicines and vaccines and continued advancement of our pipeline.

    謝謝你,彼得。早安,感謝您參加今天的電話會議。我們公司在年初取得了長足的進步,新上市的藥品和疫苗的貢獻不斷增加,產品線不斷完善。

  • We're working with focus and urgency to both realize the full potential of our near-term opportunities and to rapidly progress the next wave of innovation that will positively impact the lives of the patients we serve and drive future value creation for all of our stakeholders.

    我們正在集中精力、緊迫地努力,既要充分發揮近期機會的潛力,又要快速推進下一波創新,這將對我們服務的患者的生活產生積極影響,並推動所有利益相關者的未來價值創造。

  • In what is a dynamic global environment, we continue to work with regulators and policymakers around the world to tackle some of the biggest health challenges and ensure patient and customer access to our life-saving and life-improving medicines and vaccines.

    在充滿活力的全球環境中,我們繼續與世界各地的監管機構和政策制定者合作,以應對一些最大的健康挑戰,並確保患者和客戶能夠獲得我們拯救生命和改善生活的藥物和疫苗。

  • Over the last few years, we’ve been evolving our supply-chain strategy in an effort to better balance our manufacturing footprint, which aligns well with the new administration's efforts to regrow the US manufacturing base.

    在過去幾年裡,我們一直在改進我們的供應鏈策略,以更好地平衡我們的製造足跡,這與新政府重建美國製造業基礎的努力一致。

  • This can be seen by our efforts beginning with the passing of the Tax Cut and Jobs Act and accelerated since the pandemic. Of note, since 2018, we've invested $12 billion in US manufacturing, and we've committed to an additional $9 billion-plus for projects through 2028.

    從《減稅與就業法案》通過以來我們的努力就可以看出這一點,而且疫情爆發以來我們的努力還在加速。值得注意的是,自 2018 年以來,我們已向美國製造業投資 120 億美元,並且我們承諾在 2028 年為專案額外投資 90 多億美元。

  • Our investments are leading to more of our products for US patients being manufactured in the US as well as more opportunities for export.

    我們的投資使我們能在美國生產更多為美國患者提供的產品,同時也帶來了更多的出口機會。

  • Turning to our first quarter results. Our performance was in line with our expectations with revenue of $15.5 billion, reflecting strength in oncology, animal health, and increasingly meaningful contributions from the continued strong launches of WINREVAIR and CAPVAXIVE. As we look forward, we remain confident in our outlook for improved growth in the second half of the year.

    談到我們的第一季業績。我們的業績符合預期,營收達到 155 億美元,反映了腫瘤學、動物保健領域的強勁表現,以及 WINREVAIR 和 CAPVAXIVE 持續強勁上市帶來的越來越有意義的貢獻。展望未來,我們對下半年經濟成長改善的前景仍充滿信心。

  • Considering the current environment, we are maintaining our full year revenue and EPS guidance excluding business development charges, which Caroline will speak to in more detail. The benefit from improved foreign exchange is offset in part by approximately $200 million of expected cost from tariffs implemented to date, primarily between the US and China, and to a lesser degree, Canada and Mexico.

    考慮到當前的環境,我們維持全年收入和每股收益指引(不包括業務發展費用),Caroline 將對此進行更詳細的說明。外匯改善帶來的好處被迄今為止實施的關稅預計造成的約 2 億美元成本部分抵消,這些關稅主要發生在美國和中國之間,其次是加拿大和墨西哥之間。

  • With respect to potential additional tariffs by the US, specifically on pharmaceuticals, our global supply chain and current inventory levels put us in a good position to navigate potential near-term impacts and our ongoing efforts to locate more manufacturing in the US for US supply, including for the majority of our upcoming new products, will help us manage over the medium and long term.

    對於美國可能徵收的額外關稅,特別是針對藥品的關稅,我們的全球供應鏈和現有庫存水準使我們處於有利地位,可以應對潛在的短期影響,而且我們正在不斷努力在美國尋找更多製造基地,為美國市場提供產品,包括我們即將推出的大部分新產品,這將有助於我們在中長期內應對這些影響。

  • As I look at how we've started 2025, I'm proud of the continued advancement of our research efforts. Recently, we presented important Phase 3 data for WINREVAIR in additional patient populations, supporting the strong potential for this product to improve the lives of more people living with pulmonary arterial hypertension.

    回顧我們即將開啟的 2025 年,我為我們研究工作的持續進步感到自豪。最近,我們展示了 WINREVAIR 在其他患者群體中的重要 3 期數據,支持了該產品改善更多肺動脈高壓患者生活的巨大潛力。

  • In addition, our HIV pipeline is now coming into sharper focus with data presentations from two Phase 3 trials of islatravir-based regimens. And new clinical trial starts and regulatory submissions in oncology reinforce our belief that we are well-positioned for long-term leadership with the promise of helping even more patients with cancer.

    此外,隨著兩項基於伊拉曲韋方案的 3 期試驗的數據展示,我們的 HIV 治療管道現在變得更加清晰。腫瘤學領域新臨床試驗的開始和監管提交強化了我們的信念,即我們有能力長期保持領先地位,並有望幫助更多的癌症患者。

  • The success of biopharmaceutical innovation on the scale we're driving is not measured in quarters, but rather in years, and we're seeing compelling progress on this front. Since 2021, we've nearly tripled our late-phase pipeline through both the advancement of internally discovered compounds as well as the completion of numerous important business development transactions across multiple therapeutic areas of great unmet need, including oncology, cardiometabolic, ophthalmology, and immunology.

    我們所推動的生物製藥創新的成功不是以季度來衡量的,而是以年為單位的,而我們在這方面看到了令人矚目的進展。自 2021 年以來,我們透過推進內部發現的化合物以及完成涉及腫瘤學、心臟代謝、眼科學和免疫學等多個尚未滿足需求的治療領域的眾多重要業務開發交易,使我們的後期產品線增加了近兩倍。

  • Together, our efforts have resulted in an expanded late-phase pipeline, comprising programs having potential commercial opportunity of over $50 billion by the mid-2030s. WINREVAIR and CAPVAXIVE represent the initial launches from this robust pipeline of 20 promising potential new growth drivers we expect to come to the market over the next few years, almost all of which have blockbuster potential. Looking ahead, we have a rich slate of data readouts, presentations, filings, and additional approvals.

    透過共同努力,我們已經擴大了後期研發管線,其中包括到 2030 年代中期具有超過 500 億美元潛在商業機會的項目。WINREVAIR 和 CAPVAXIVE 是這 20 種有前景的潛在新成長動力產品線中的首批產品,我們預計這些產品線將在未來幾年內進入市場,幾乎所有產品都具有巨大的潛力。展望未來,我們擁有豐富的數據讀數、演示、文件和額外批准。

  • Our pipeline includes some of the world's most scientifically advanced modalities. And Dean and our research colleagues are advancing several molecules that have foundational multi-indication potential in areas of significant unmet need.

    我們的產品線包括一些世界上科學最先進的模式。Dean 和我們的研究同事正在開發幾種在尚未滿足的重大需求領域具有基礎多適應症潛力的分子。

  • We've also deepened and extended our commitment to early research and development, and over the next few years, expect many of these programs to advance to Phase 2 and to become visible to you. Thanks to the incredible efforts of our dedicated team and the strong progress we are achieving, we believe that we're well-positioned to successfully navigate through the KEYTRUDA LOE period. And our work is not finished.

    我們也深化並擴大了對早期研究和開發的承諾,並預計在未來幾年內,其中許多項目將進入第二階段並為您所知。感謝我們敬業團隊的不懈努力和我們取得的巨大進步,我們相信我們有能力成功度過 KEYTRUDA LOE 時期。我們的工作還未完成。

  • Science and value-driven business development remains a top priority, and we continue to assess opportunities with urgency and an eye toward driving near- and long-term growth and value creation. In summary, our results reflect the continued demand for breakthrough therapies and novel solutions that can address global health challenges.

    科學和價值驅動的業務發展仍然是重中之重,我們將繼續緊急評估機遇,著眼於推動近期和長期的成長和價值創造。總而言之,我們的研究結果反映了對能夠應對全球健康挑戰的突破性療法和新解決方案的持續需求。

  • We're leveraging our scientific leadership to deliver the next wave of innovation that can save and improve lives around the world. Our commercial performance today continues to enable the advancement of our pipeline, and in turn, create long-term value for patients, customers, and shareholders. We remain confident in our strategic direction, our commitment to research and development as the source for sustainable value creation and our enduring promise to positively impact patients.

    我們正在利用我們的科學領導來推動下一波創新,以拯救和改善世界各地的生活。我們今天的商業表現繼續推動著我們產品線的進步,進而為患者、客戶和股東創造長期價值。我們對我們的策略方向、對研發作為永續價值創造來源的承諾以及對患者產生積極影響的持久承諾充滿信心。

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

    說完這些,我會把電話轉給卡洛琳。

  • Caroline Litchfield - Executive Vice President and Chief Financial Officer

    Caroline Litchfield - Executive Vice President and Chief Financial Officer

  • Thank you, Rob. Good morning. As Rob noted, first quarter performance was in line with our expectations. The fundamentals of our business remain healthy fueled by robust global demand for our innovative portfolio.

    謝謝你,羅布。早安.正如 Rob 所說,第一季的表現符合我們的預期。受全球對我們創新產品組合的強勁需求的推動,我們的業務基本面依然健康。

  • We are confident in our ability to deliver on the promise of today while we make strategic investments to enable the innovations of tomorrow, leveraging leading-edge science to save and improve lives around the world.

    我們有信心兌現今天的承諾,同時我們將進行策略性投資,以實現未來的創新,利用尖端科學來拯救和改善世界各地的生活。

  • Now turning to our first quarter results. Total company revenues were $15.5 billion, a decrease of 2% or an increase of 1%, excluding the impact of foreign exchange. As expected, results were impacted by a decline in sales of GARDASIL in China of approximately $1.1 billion, reducing growth, excluding foreign exchange, by 7 percentage points.

    現在來看看我們的第一季業績。公司總營收為 155 億美元,下降 2%,扣除外匯影響則成長 1%。正如預期,業績受到 GARDASIL 在中國銷售額下降約 11 億美元的影響,扣除外匯因素後,成長率降低了 7 個百分點。

  • Excluding these sales and the impact from foreign exchange, global growth was 8% primarily driven by new products, WINREVAIR and CAPVAXIVE, as well as strength in oncology and animal health. The following revenue comments will be on an ex-exchange basis.

    除去這些銷售額和外匯的影響,全球成長率為 8%,主要得益於新產品 WINREVAIR 和 CAPVAXIVE,以及腫瘤學和動物保健領域的強勁成長。以下收入評論將以交易所為基礎。

  • In Oncology, sales of KEYTRUDA grew 6% to $7.2 billion. Global growth was driven by increased uptake from earlier stage cancers and robust demand from metastatic indications. In the earlier-stage setting, growth was driven by increased utilization in resectable triple-negative breast cancer, renal cell carcinoma, and non-small cell lung cancer.

    在腫瘤學領域,KEYTRUDA 的銷售額成長 6%,達到 72 億美元。全球成長的動力來自於早期癌症治療的增加以及轉移性適應症的強勁需求。在早期階段,可切除的三陰性乳癌、腎細胞癌和非小細胞肺癌的利用率增加推動了成長。

  • In metastatic disease, we saw increased use of KEYTRUDA in combination with Padcev in first-line, locally advanced urothelial cancer as well as KEYTRUDA in combination with chemotherapy in first-line endometrial cancer. In the US, as previously communicated, growth was growth was negatively impacted by approximately $250 million due to the timing of wholesaler purchases.

    在轉移性疾病中,我們發現 KEYTRUDA 與 Padcev 合併用於第一線局部晚期尿路上皮癌治療,以及 KEYTRUDA 與化療合併用於第一線子宮內膜癌治療的使用增加。在美國,如同之前所傳達的,由於批發商採購的時間安排,成長受到了約 2.5 億美元的負面影響。

  • Our broad Oncology portfolio achieved strong growth driven by WELIREG with sales increasing 63% to $137 million due to increased use in certain patients with previously treated advanced renal cell carcinoma in the US.

    我們廣泛的腫瘤學產品組合在 WELIREG 的推動下實現了強勁增長,由於美國某些先前接受過治療的晚期腎細胞癌患者的使用增加,其銷售額增長了 63%,達到 1.37 億美元。

  • WELIREG is now the market leader in the treatment of patients with advanced renal cell carcinoma following prior therapies. In vaccines, GARDASIL sales were $1.3 billion, a decrease of 40% driven by China, where we see elevated channel inventories and continued soft demand. In the rest of the world, growth was 16%. In the US, sales benefited from price and demand.

    WELIREG 現在是接受過先前治療的晚期腎細胞癌患者治療領域的市場領導者。在疫苗方面,GARDASIL 的銷售額為 13 億美元,下降了 40%,原因是中國通路庫存增加,需求持續疲軟。世界其他地區的成長率為16%。在美國,銷售受益於價格和需求。

  • Outside the US and China, growth was driven by higher overall demand, including from the catch-up cohort in Japan. In pneumococcal, CAPVAXIVE sales were $107 million, driven primarily by demand from the retail pharmacy segment.

    在美國和中國以外,成長是由更高的總體需求推動的,其中包括來自日本的追趕者。在肺炎球菌領域,CAPVAXIVE 的銷售額為 1.07 億美元,主要受到零售藥局領域需求的推動。

  • We have made great progress in the early stages of this launch and are well positioned to help protect adults from invasive pneumococcal disease. VAXNEUVANCE sales increased 7% as growth from launches in international markets was partially offset by competitive pressures in the US.

    我們在此次發布的早期階段取得了巨大進展,並已做好準備幫助保護成年人免受侵襲性肺炎球菌疾病的侵害。VAXNEUVANCE 的銷售額成長了 7%,因為美國國內的競爭壓力部分抵消了國際市場的成長。

  • In cardiovascular, the strong momentum of the ongoing launch of WINREVAIR continues with global sales of $280 million. The launch continues to perform in line with our high expectations, and we remain excited about the significant benefit WINREVAIR is providing for patients.

    在心血管領域,正在推出的 WINREVAIR 持續保持強勁勢頭,全球銷售額達 2.8 億美元。此次發布會的表現繼續符合我們的高期望,我們仍然對 WINREVAIR 為患者帶來的巨大益處感到興奮。

  • In the US, more than 1,400 patients received a prescription during the quarter. We are continuing to see a steady increase in the percentage of new prescriptions for patients whose background PAH therapies do not include a prostacyclin. Outside the US, we continue to progress with launches and reimbursement.

    在美國,本季有超過 1,400 名患者獲得了處方。我們持續看到,針對 PAH 背景療法中不包含前列環素的患者的新處方比例穩步上升。在美國以外,我們繼續推進產品發布和報銷工作。

  • Overall, we are very pleased with the uptake of WINREVAIR and look forward to positively impacting the lives of more patients with pulmonary arterial hypertension. The strength of the additional data from the clinical development program, which Dean will speak to in a moment, provides further confidence to physicians and patients and supports our belief in WINREVAIR's significant potential.

    總體而言,我們對 WINREVAIR 的普及感到非常高興,並期待對更多肺動脈高壓患者的生活產生積極影響。臨床開發計劃提供的額外數據(Dean 稍後會談到)為醫生和患者提供了進一步的信心,並支持了我們對 WINREVAIR 巨大潛力的信念。

  • Our animal health business delivered another quarter of robust growth with sales increasing 10%. Livestock growth reflects higher demand across all species as well as the benefit from timing of sales in ruminant and sales from the Aqua portfolio acquired from Elanco. Companion animal sales growth reflects price.

    我們的動物保健業務再創季度強勁成長,銷售額成長了 10%。牲畜產量的成長反映了所有品種需求的增加,以及反芻動物銷售時機和從 Elanco 收購的 Aqua 產品組合銷售帶來的好處。伴侶動物銷售成長反映了價格。

  • 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 82.2%, an increase of 1 percentage point driven by favorable product mix. Operating expenses decreased to $6.1 billion. There were no significant business development expenses in the quarter compared with a $656 million charge a year ago. Excluding this charge, operating expenses grew 6%, reflecting disciplined investments in support of our robust early- and late-phase pipeline and key growth drivers.

    現在我將向您介紹我們損益表的其餘部分,我的評論將基於非 GAAP 基礎。毛利率為82.2%,受有利的產品組合推動,成長了1個百分點。營運支出下降至61億美元。與去年同期的 6.56 億美元業務開發費用相比,本季沒有重大業務開發費用。不計入這項費用,營運費用成長了 6%,反映了我們為支持強勁的早期和後期管道和關鍵成長動力而進行的嚴格投資。

  • Other expense was $25 million. Our tax rate of 14.2% benefited from certain discrete items. Taken together, earnings per share were $2.22. Now turning to our 2025 non-GAAP guidance. As Rob noted, we are maintaining our full year revenue guidance of between $64.1 billion and $65.6 billion.

    其他費用為2500萬美元。我們的稅率為 14.2%,這得益於某些單項項目。總體而言,每股收益為 2.22 美元。現在轉向我們的 2025 年非 GAAP 指引。正如羅布所說,我們維持全年營收預期在 641 億美元至 656 億美元之間。

  • This range represents growth of 1% to 3%, excluding a negative impact from foreign exchange of approximately 1% using mid-April rates. Our gross margin assumption is now approximately 82%. This includes approximately $200 million in costs related to the tariffs implemented to date. Operating expenses are now assumed to be between $25.6 billion and $26.6 billion. This range now includes a $200 million payment related to the license agreement with Hengrui Pharma, which is expected to close in the second quarter.

    這一範圍代表著 1% 至 3% 的成長率,不包括使用 4 月中旬匯率計算的約 1% 的外匯負面影響。我們現在的毛利率假設約為82%。其中包括迄今為止實施的關稅相關約 2 億美元的成本。目前預計營運費用在 256 億美元至 266 億美元之間。該範圍目前包括與恆瑞醫藥達成的許可協議相關的 2 億美元付款,預計該協議將於第二季完成。

  • It also includes the $300 million tech transfer payment related to LaNova, which remains in our guidance but has not yet occurred. As a reminder, our guidance does not assume additional significant potential business development transactions. Other expense is expected to be between $300 million and $400 million. We assume a full year tax rate between 15.5% and 16.5%. We assume approximately 2.51 billion shares outstanding.

    它還包括與 LaNova 相關的 3 億美元技術轉移支付,這仍在我們的指導範圍內,但尚未發生。提醒一下,我們的指導並不假設額外的重大潛在業務發展交易。其他支出預計在3億至4億美元之間。我們假設全年稅率在 15.5% 至 16.5% 之間。我們假設流通股數約為 25.1 億股。

  • Taken together, we expect EPS of $8.82 to $8.97. This range includes a negative impact from foreign exchange of more than $0.20 using mid-April rates. Recall our prior guidance range was $8.88 to $9.03. If not for the one-time charge of $200 million related to Hengrui or $0.06 per share, our guidance range is unchanged. As you consider your models, there are a few items to keep in mind.

    綜合來看,我們預計每股收益為 8.82 美元至 8.97 美元。根據 4 月中旬的匯率計算,此範圍包括超過 0.20 美元的外匯負面影響。回想一下,我們之前的指導範圍是 8.88 美元至 9.03 美元。如果不是與恆瑞相關的 2 億美元一次性費用或每股 0.06 美元,我們的指導範圍保持不變。當您考慮模型時,需要記住幾點。

  • Following the successful HPV catch-up vaccination program in Japan, we expect uptake to moderate as future sales will predominantly reflect the primary age cohort. As a result, global GARDASIL growth excluding China, while still strong, is anticipated to slow going forward.

    在日本成功實施 HPV 補種疫苗接種計劃之後,我們預計接種率將會放緩,因為未來的銷售將主要反映主要年齡群體。因此,除中國以外,全球 GARDASIL 的成長雖然依然強勁,但預計未來將會放緩。

  • For KEYTRUDA, the timing of wholesaler purchasing in the US negatively impacted sales by approximately $250 million in the first quarter and is expected to positively impact sales by roughly the same amount in the third quarter.

    對於 KEYTRUDA 而言,美國批發商採購的時間對第一季的銷售額產生了約 2.5 億美元的負面影響,預計對第三季的銷售額將產生大致相同的正面影響。

  • As a reminder, we lowered the list prices for the JANUVIA family of products in the US at the beginning of 2025. The Lower list prices reduce the rebate amount our company pays to Medicaid and as a result, we expect higher net sales for these products in 2025. First quarter sales of the JANUVIA family of products in the US also benefited by more than $100 million from favorable one-time true-ups. Now turning to capital allocation, where our strategy remains unchanged.

    提醒一下,我們在 2025 年初降低了美國 JANUVIA 系列產品的定價。較低的標價減少了我們公司向醫療補助支付的回扣金額,因此,我們預計 2025 年這些產品的淨銷售額會更高。JANUVIA 系列產品在美國第一季的銷售額也因一次性調整的有利因素而成長了 1 億多美元。現在轉向資本配置,我們的策略保持不變。

  • We will continue to prioritize investments in our business to drive near and long-term growth and returns for our shareholders. Our company is rapidly moving toward a future with a more diversified portfolio of growth drivers.

    我們將繼續優先投資於我們的業務,以推動近期和長期的成長並為股東帶來回報。我們的公司正快速邁向擁有更多元化成長動力組合的未來。

  • As we continue to assess our business, we are likely to take actions that will seek to maximize the potential of these opportunities by Investing with discipline while transforming our business to drive continuous productivity across the company. We intend to communicate more about these efforts later this year.

    隨著我們繼續評估我們的業務,我們可能會採取行動,尋求最大限度地發揮這些機會的潛力,透過有紀律地投資,同時轉變我們的業務,推動整個公司的持續生產力。我們打算在今年稍後就這些努力進行更多交流。

  • We remain committed to our dividend, with the goal of increasing it over time. Business development remains an important priority. We continue to actively evaluate opportunities to execute additional science-driven, value-creating transactions. We increased our share repurchases in the quarter to approximately $1.2 billion, similar to the full year amount in 2024. We expect the pace of repurchase to continue at this level given our strong balance sheet.

    我們將繼續致力於提高股息,並力爭隨著時間的推移增加股息。業務發展仍然是一項重要任務。我們將繼續積極評估執行更多以科學為導向、創造價值的交易的機會。我們本季的股票回購額增加至約 12 億美元,與 2024 年全年的金額相似。鑑於我們強勁的資產負債表,我們預計回購速度將維持在這一水平。

  • Our top priority, however, remains to invest fully behind our growth drivers and pipeline as well as business development. To conclude, we are confident in the outlook for our business driven by our strong portfolio and exceptional pipeline.

    然而,我們的首要任務仍然是全力投資於我們的成長動力和管道以及業務發展。總而言之,憑藉強大的產品組合和卓越的產品線,我們對我們的業務前景充滿信心。

  • With investment in innovation and our ongoing focus on execution, we are well-positioned to deliver value to patients customers, and shareholders now and well into the future.

    透過對創新的投資和對執行的持續關注,我們現在和將來都能夠為患者、客戶和股東創造價值。

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

    說完這些,我現在想把電話轉給 Dean。

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

    Dean Li - Executive Vice President and President, Research Laboratories

  • Thank you, Caroline. Good morning. Progress continued in the first quarter with a steady cadence of positive clinical and regulatory milestones. Today, I will provide updates from programs in cardiometabolic disease, HIV, vaccines, and will close with Oncology. Starting with cardiometabolic disease.

    謝謝你,卡洛琳。早安.第一季持續取得進展,臨床和監管里程碑穩步取得積極進展。今天,我將介紹心臟代謝疾病、愛滋病毒、疫苗等計畫的最新進展,最後介紹腫瘤學。從心臟代謝疾病開始。

  • Since first approval just over a year ago, WINREVAIR, the first and only active in signaling inhibitor for the treatment of pulmonary arterial hypertension, has continued to generate clear evidence of benefit for a broad spectrum of patients with PAH. Last month, detailed results from the Phase 3 ZENITH trial evaluating high-risk patients with PAH were presented at the American College of Cardiology's ACC '25 Conference.

    自一年多前首次核准以來,WINREVAIR——第一個也是唯一一個用於治療肺動脈高壓的信號抑制劑——已持續為廣大 PAH 患者提供明確益處的證據。上個月,在美國心臟病學會 ACC '25 會議上公佈了針對 PAH 高風險患者的 3 期 ZENITH 試驗的詳細結果。

  • The findings showed an important 76% risk reduction in the composite of all-cause death, lung transplantation, and PAH hospitalization with the Kaplan-Meier curve illustrating an early and sustained separation as early as four to five weeks after initiation of WINREVAIR.

    研究結果顯示,全因死亡、肺移植和 PAH 住院綜合風險降低了 76%,Kaplan-Meier 曲線表明,在開始 WINREVAIR 治療後四至五週內,風險就出現了早期和持續的分離。

  • Results were published simultaneously in the New England Journal of Medicine. ZENITH is the first positive trial in PAH with a primary endpoint comprised entirely of major outcome measures and the first to be stopped early for overwhelming efficacy.

    研究結果同時發表在《新英格蘭醫學雜誌》。ZENITH 是 PAH 領域中第一個以主要終點完全由主要結果指標構成的陽性試驗,也是第一個因療效顯著而提前終止的試驗。

  • The significant reduction in risk of major morbidity and mortality events reinforces WINREVAIR's efficacy. The safety profile in ZENITH was generally consistent with that observed in previous studies.

    主要發病率和死亡事件風險的顯著降低增強了 WINREVAIR 的療效。ZENITH 的安全性與先前研究觀察到的總體一致。

  • As a reminder, prompted by the early stoppage of the ZENITH study and a review of the totality of data from the WINREVAIR clinical program to date, the external steering committee determined that the Phase 3 HYPERION study had lost clinical ecopolis and should also be stopped early. All participants have now been given the option to receive WINREVAIR. We anticipate sharing data from the HYPERION study later this year.

    提醒一下,由於 ZENITH 研究的提前停止以及對 WINREVAIR 臨床計劃迄今為止的全部數據進行審查,外部指導委員會確定第 3 階段 HYPERION 研究已經失去了臨床生態,也應該提前停止。所有參與者現在都可以選擇接收 WINREVAIR。我們預計將於今年稍後分享 HYPERION 研究的數據。

  • The clinical benefit and statistically significant improvement observed across a range of patients receiving WINREVAIR in the STELLAR and ZENITH study provide strong evidence for its potential to be practice-changing and to alter the trajectory for patients with this devastating disease.

    在 STELLAR 和 ZENITH 研究中,接受 WINREVAIR 治療的一系列患者所觀察到的臨床益處和統計學上的顯著改善,為其改變實踐和改變這種毀滅性疾病患者的軌蹟的潛力提供了強有力的證據。

  • The clinical program also includes the ongoing long-term extension study, SOTERIA, as well as a Phase 2 LIGHTRAY study, which is being conducted to support the development of an auto-injector option for patients. In addition, the Phase 2 CADENCE study exploring the potential in pulmonary hypertension due to left heart disease, a specific segment within WHO Group II, has completed recruitment and is on track for completion later this year.

    該臨床計畫還包括正在進行的長期擴展研究 SOTERIA,以及正在進行的 2 期 LIGHTRAY 研究,旨在支持為患者開發自動注射器選項。此外,第二階段 CADENCE 研究探索了左心疾病引起的肺動脈高壓(WHO 第二組內的特定部分)的潛力,該研究已完成招募,預計將於今年稍後完成。

  • We continue to bolster our portfolio of candidates targeting cardiometabolic disease. In March, we announced an exclusive license agreement with Hengrui Pharma for HRS-5346, an investigational oral small molecule lipoprotein A or Lp(a) formation inhibitor.

    我們將繼續加強針對心臟代謝疾病的候選藥物組合。今年 3 月,我們宣布與恆瑞醫藥就 HRS-5346(一種正在研口服小分子脂蛋白 A 或 Lp(a) 形成抑制劑)達成獨家許可協議。

  • Elevated levels of Lp(a) in the blood are an inherited atherosclerotic cardiovascular disease risk factor for which there are currently no approved treatment options. Hengrui recently initiated a Phase 2 clinical trial for HRS-5346 in China.

    血液中 Lp(a) 水平升高是遺傳性動脈粥狀硬化性心血管疾病的風險因素,目前尚無核准的治療方法。恆瑞近期在中國啟動了HRS-5346的2期臨床試驗。

  • We are planning a robust global clinical development program that expands and complements our broader cardiometabolic pipeline. Next to Vaccines. We continue to secure regulatory approvals globally for CAPVAXIVE.

    我們正在規劃一項強大的全球臨床開發計劃,以擴大和補充我們更廣泛的心臟代謝產品線。疫苗旁邊。我們將繼續在全球範圍內爭取 CAPVAXIVE 的監管批准。

  • More recently, the European Commission granted approvals for active immunization for the prevention of invasive disease and pneumonia caused by streptococcus pneumonia in adults. This is based on safety and immunogenicity data from multiple pivotal studies in the program and is the fourth approval for CAPVAXIVE, building on prior approvals in the US, Canada, and Australia.

    最近,歐盟委員會批准了主動免疫以預防成人侵襲性疾病和肺炎鏈球菌引起的肺炎。這是基於該計畫多項關鍵研究的安全性和免疫原性數據,也是 CAPVAXIVE 在美國、加拿大和澳洲先前批准的基礎上獲得的第四次批准。

  • GARDASIL-9 was recently approved by the National Medical Products Administration of China to help prevent certain HPV-related cancers and diseases in males 16 to 26 years old, making it the first nine-valent HPV vaccine approved for certain males and females in China.

    GARDASIL-9 最近獲得中國國家藥品監督管理局的批准,用於幫助預防 16 至 26 歲男性的某些 HPV 相關癌症和疾病,這使其成為中國首個獲批用於特定男性和女性的九價 HPV 疫苗。

  • Turning to HIV. Detailed results from two pivotal Phase 3 trials evaluating adults with virologically suppressed HIV-1 who switched to the investigational once-daily oral fixed-dose combination of doravirine and islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, were presented at the conference on retrovirus and opportunistic infections.

    轉向愛滋病毒。在逆轉錄病毒和機會性感染會議上,介紹了兩項關鍵性 3 期試驗的詳細結果,這兩項試驗評估了 HIV-1 病毒學受到抑制的成年人,他們改用試驗性的每日一次口服固定劑量多拉韋林和伊斯拉曲韋(一種試驗性的核苷逆轉錄酶易位抑製劑)的組合。

  • In both trials, at week 48, doravirine and islatravir met the primary efficacy success criteria for noninferiority to comparator antiretroviral therapies and primary safety objectives. The combinations of doravirine and islatravir is the first complete two-drug regimen without an integrated strand transfer inhibitor to demonstrate comparable efficacy and safety to the three-drug inside-based regimen, Biktarvy, in a Phase 3 trial.

    在這兩項試驗中,第 48 週時,多拉韋林和伊斯拉曲韋均達到了不劣於對照抗逆轉錄病毒療法的主要療效成功標準和主要安全目標。多拉韋林和伊斯拉曲韋的組合是第一個完整的不含整合鏈轉移抑制劑的雙藥方案,在 3 期試驗中表現出與三藥內部方案 Biktarvy 相當的療效和安全性。

  • We plan to submit applications for marketing authorization to regulatory agencies by midyear. These data and additional programs evaluating longer-acting regimens for treatment and free exposure prophylaxis underscore our ongoing commitment to find new options that address the evolving needs of people at risk and living with HIV.

    我們計劃在年中向監管機構提交行銷授權申請。這些數據和評估長效治療方案和免費暴露預防的其他項目強調了我們持續致力於尋找新的選擇,以滿足處於危險之中和感染愛滋病毒的人不斷變化的需求。

  • Moving to oncology. Last month, at the European Lung Cancer Congress, we announced detailed earnings from a pivotal Phase 3 trial evaluating a six-week dosing regimen of the investigational subcutaneous fixed-dose combination of pembrolizumab and berahyaluronidase alfa with chemotherapy versus intravenous KEYTRUDA with chemotherapy.

    轉向腫瘤學。上個月,在歐洲肺癌大會上,我們公佈了一項關鍵性 3 期試驗的詳細收益,該試驗評估了皮下注射固定劑量的派姆單抗和貝拉雅魯丹酶 alfa 與化療聯合治療與靜脈注射 KEYTRUDA 與化療聯合治療的六週給藥方案。

  • The study met its dual primary endpoints, demonstrating inferior pharmacokinetics for subcutaneous pembrolizumab versus intravenous KEYTRUDA. Consistent results also reported for efficacy and safety endpoints across treatment arms.

    該研究達到了其雙重主要終點,顯示皮下注射 pembrolizumab 的藥物動力學不如靜脈注射 KEYTRUDA。各治療組的療效和安全性終點也報告了一致的結果。

  • The median time for administration of subcutaneous pembrolizumab given every six weeks was approximately two minutes, a meaningful reduction compared to the time needed to administer KEYTRUDA as an IV infusion. Of note, at the American Association for Cancer Research meeting next week, data from another study evaluating a three-week dosing regimen will be presented.

    每六週進行一次皮下注射派姆單抗的中位給藥時間約為兩分鐘,與靜脈輸注 KEYTRUDA 所需時間相比,有顯著縮短。值得注意的是,在下週舉行的美國癌症研究協會會議上,將發表另一項評估三週給藥方案的研究數據。

  • The FDA has set a PDUFA date of September 23, and the European Medicines Agency is reviewing the application. We are seeking approval for both a six-week and a three-week dosing option. If approved, subcutaneous pembrolizumab would provide an important option for health care systems and patients, most notably, for those in earlier-stage settings where KEYTRUDA continues to have an unparalleled breadth of approval and a significant impact for patients.

    FDA 已將 PDUFA 日期定為 9 月 23 日,歐洲藥品管理局正在審查該申請。我們正在尋求六週和三週劑量方案的批准。如果獲得批准,皮下注射派姆單抗將為醫療保健系統和患者提供一個重要選擇,尤其是對於那些處於早期階段的患者,KEYTRUDA 在這些情況下繼續擁有無與倫比的批准廣度並對患者產生重大影響。

  • The FDA granted priority review for KEYTRUDA as part of a perioperative treatment regimen for patients newly diagnosed with Stage 3 or 4A resectable locally advanced head and neck squamous cell carcinoma based on the KEYNOTE-689 study. That PDUFA date is June 23.

    美國食品藥物管理局(FDA)根據 KEYNOTE-689 研究,對 KEYTRUDA 授予優先審查權,作為新診斷為 3 期或 4A 期可切除局部晚期頭頸部鱗狀細胞癌患者的圍手術期治療方案的一部分。PDUFA 日期是 6 月 23 日。

  • As a reminder, this is the first trial in 20 years for patients with resected locally advanced head and neck squamous cell carcinoma and the first Phase 3 trial to show a statistically significant event-free survival benefit of neoadjuvant plus adjuvant therapy for newly diagnosed patients in this setting.

    提醒一下,這是 20 年來針對切除局部晚期頭頸部鱗狀細胞癌患者進行的首次試驗,也是第一項顯示新輔助加輔助治療對此類新診斷患者俱有統計學上顯著的無事件生存益處的 3 期試驗。

  • Earlier intervention has the potential to move outcomes and reduce the burden of disease in this patient population. Results will be submitted to regulatory agencies, and if approved, this will mark the 10th indication of a KEYTRUDA-based regimen for the treatment of an earlier-stage cancer.

    早期介入有可能改善治療結果並減輕該患者群體的疾病負擔。結果將提交給監管機構,如果獲得批准,這將標誌著基於 KEYTRUDA 的方案用於治療早期癌症的第 10 個適應症。

  • Detailed findings will be presented at the American Association for Cancer Research meeting next week, where it may be important to scrutinize the Kaplan-Meier plot for the divergence of the curves as a sign of event-free survival benefit.

    詳細研究結果將於下週在美國癌症研究協會會議上公佈,屆時仔細檢查 Kaplan-Meier 圖的曲線發散度可能很重要,這是無事件生存益處的標誌。

  • Based on the LITESPARK-004 and LITESPARK-005 trials, we received the first conditional European Commission approval for WELIREG for the treatment of adults with von Hippel-Lindau disease who require therapy for associated localized renal cell carcinoma, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors and advanced clear cell RCC that progressed following two or more lines of therapy that included a PD-1 or a PD-L1 inhibitor and at least two vascular endothelial growth factor targeted therapies.

    根據 LITESPARK-004 和 LITESPARK-005 試驗,我們獲得了歐盟委員會對 WELIREG 的首個有條件批准,用於治療患有馮·希佩爾-林道病的成年人,這些患者需要治療相關的局限性腎細胞癌、中樞神經系統血管母細胞瘤或胰腺神經內分泌腫瘤和晚期透明細胞 RCC,並且在接受 PD1-1-1-1抑制劑和至少兩種血管內皮生長因子標靶療法在內的兩種或兩種以上療法後病情出現進展。

  • Please mark your calendars for the evening of Monday, June 2, for an investor event at the 2025 ASCO Annual Meeting in Chicago, where we will provide an update on pipeline progress and the latest on our oncology strategy.

    請在日曆上標記 6 月 2 日星期一晚上,參加在芝加哥舉行的 2025 年 ASCO 年會上的投資者活動,屆時我們將提供有關管道進展的最新信息以及我們腫瘤學戰略的最新信息。

  • Finally, we have a number of near-term milestones to look out for this year, including, in Oncology, upcoming PDUFA dates for KEYNOTE-689 an earlier-stage head and neck squamous cell carcinoma in June; subcutaneous pembrolizumab in September; in RSV, the upcoming PDUFA for clesrovimab in June; in the cardiometabolic space, anticipated results from three Phase 3 registration-enabling studies evaluating our oral PCSK9 inhibitor candidate, enlicitide, for the treatment of hypercholesterolemia; and the scheduled full primary completion date of the Phase 2 CADENCE study evaluating WINREVAIR pulmonary hypertension due to left heart disease; as well as the final readout from the Phase 3 HYPERION study; lastly, in HIV, filing for doravirine and islatravir regimen and results from the Phase 2a trial for MK-8527, a novel NRTTI candidate, as a potentially important once-monthly oral option for pre-exposure prophylaxis.

    最後,我們今年有許多近期里程碑值得關注,包括在腫瘤學領域,即將於 6 月公佈 KEYNOTE-689(一種早期頭頸部鱗狀細胞癌)的 PDUFA 日期; 9 月份皮下注射 pembrolizumab;在 RSV 方面,即將於 6 月簽署 clesrovimab 的 PDUFA;用於治療高膽固醇血症的效果;以及評估 WINREVAIR 治療左心疾病所致肺動脈高壓的第 2 階段 CADENCE 研究的預定全面主要完成日期;以及第三階段 HYPERION 研究的最終讀數;最後,在 HIV 領域,申請多拉韋林和伊斯拉曲韋方案,並公佈一項新 NRTTI 候選藥物的重要方法 (7527 期,作為潛在藥物治療的新階段。

  • In closing, we continue to advance our pipeline and execute on our strategy with speed and rigor I look forward to providing further updates on our progress.

    最後,我們將繼續推進我們的產品線,並快速、嚴謹地執行我們的策略,我期待著提供有關我們進展的進一步更新。

  • 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

  • Thanks, Dean. Dustin, we're ready for Q&A. We request that analysts limit themselves to one question, please.

    謝謝,迪恩。達斯汀,我們準備好要進行問答了。我們要求分析師只問一個問題。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Geoff Meacham, Citibank.

    花旗銀行的傑夫‧米查姆。

  • Geoff Meacham - Analyst

    Geoff Meacham - Analyst

  • I guess I'll kick it off with a tariff question. So Rob, I recognize it's hard to talk specifics. But maybe at a high level, can you talk about Merck's mitigating strategies as an offset, whether it's a new CapEx cycle, whether it's changing the elements of the supply chain, or even raising US price?

    我想我會以關稅問題開始。所以羅布,我知道談論具體細節很困難。但也許從高層次上講,您能否談談默克公司的緩解策略作為抵銷措施,無論是新的資本支出週期,還是改變供應鏈要素,甚至提高美國價格?

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. No, Geoff, I appreciate the question. And obviously, Caroline spoke to the tariffs that we've included in our [guidance] (corrected by company after the call) so far, the $200 million. And just to be clear, that relates to the existing tariffs that have been announced largely between China and the US, and to a lesser extent, Canada and Mexico. I think you're really referring to the potential for further sector-specific tariffs that could come and what we're doing.

    是的。不,傑夫,我很感謝你提出這個問題。顯然,卡羅琳談到了我們迄今為止在[指導]中包含的關稅(電話會議後公司已更正),即 2 億美元。需要明確的是,這主要與中國和美國之間宣布的現有關稅有關,在較小程度上也與加拿大和墨西哥之間宣布的關稅有關。我認為您實際上指的是可能進一步徵收針對特定行業的關稅以及我們正在採取的措施。

  • And in that regard, we've been very focused, and I tried to highlight this in the script, we've actually had started to change and rebalance our supply chain strategy, going back -- actually beginning with the Tax Cut and Jobs Act, where we started moving more towards being able to have US for US, Europe for Europe, and Asia for Asia. And we've been in the process of doing that. That was a big part of where we announced that we've spent $12 billion since that time to date. And then we expect to spend an additional $9 billion-plus.

    在這方面,我們一直非常專注,我試圖在劇本中強調這一點,我們實際上已經開始改變和重新平衡我們的供應鏈戰略,回溯到——實際上是從《減稅和就業法案》開始,我們開始更多地朝著美國為美國、歐洲為歐洲、亞洲為亞洲的方向發展。我們一直在做這件事。這是我們宣布自那時起至今已花費 120 億美元的一個重要部分。然後我們預計還要再花費90多億美元。

  • And I expect, frankly, that number is going to grow going forward. So we have already been in the process of changing our supply chain. But what we've done specifically, in the near term, we have, I think, done a good job of managing our inventory.

    坦白說,我預計這個數字未來還會成長。因此,我們已經開始改變我們的供應鏈。但具體來說,就短期而言,我認為我們在庫存管理方面做得很好。

  • So as you look at 2025, we're well-positioned with inventory to be able to mitigate anything we could see in the short term. And then in the medium to long term, we've already started to identify where we can either reposition our own manufacturing, so change the priorities of existing plants; bring on external manufacturing, in some cases, to bridge gaps; and then finally, to build internal manufacturing long term so that we have that in our base going forward.

    因此,展望 2025 年,我們的庫存已做好準備,能夠緩解短期內可能出現的任何影響。從中長期來看,我們已經開始確定我們可以在哪裡重新定位我們自己的製造業,從而改變現有工廠的優先事項;在某些情況下引入外部製造來彌補差距;最後,長期建設內部製造業,以便我們在未來擁有這樣的基礎。

  • So really, as I look at it, short term, I think we're in a good shape. Medium and long term, we're taking the steps to position ourselves. And that really is our main efforts. We are not using and do not really see price as a lever for tariffs just given there's always limitations in what you can do there. So for us, it's more about how do we optimize our supply chain.

    因此,從我的角度來看,短期來看,我認為我們處於良好狀態。從中期和長期來看,我們正在採取措施來定位自己。這確實是我們主要的努力方向。我們並沒有使用價格作為關稅的槓桿,也沒有真正將價格視為關稅的槓桿,因為價格方面所能做的事情總是有限的。因此對我們來說,更重要的是如何優化我們的供應鏈。

  • But again, a lot of what we're doing now, frankly, we were already underway in. So in many ways, we are aligned with what the administration is wanting to do and feel that we are in a position to be able to do that quite effectively.

    但坦白說,我們現在做的很多事情我們都已經在進行了。因此,在很多方面,我們都與政府想要做的事情保持一致,並且認為我們有能力非常有效地做到這一點。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thanks, Geoff. Next question, please, Dustin.

    偉大的。謝謝,傑夫。達斯汀,請問下一個問題。

  • Operator

    Operator

  • Tim Anderson, Bank of America.

    美國銀行的蒂姆·安德森。

  • Tim Anderson - Analyst

    Tim Anderson - Analyst

  • So I'm going to ask about long-term guidance, Rob. It was something I asked last quarter. I wanted to ask again. So lots of concerns about KEYTRUDA going into IRA facing -- patent expired at the end of '28. And in my view, unless you guys kind of give clarity on what that means downstream at '28, my fear is going to continue to haunt the stock that now trades at a single-digit PE multiple, which is a level that Merck shares have not been other than once, in the last 25 years, in '09 after you buy Schering-Plough.

    所以我要問長期指導的問題,羅布。這是我上個季度問過的問題。我想再問一次。因此,人們對 KEYTRUDA 進入 IRA 有很多擔憂——其專利於 28 年底到期。在我看來,除非你們能清楚地解釋 28 美元的市盈率意味著什麼,否則我的擔憂將繼續困擾著這隻股票,目前該股票的市盈率只有個位數,這是默克股價在過去 25 年中從未達到過的水平,除了 2009 年你收購先靈葆雅之後的一次。

  • So last quarter, when I asked that, you seem to imply you might give it at some point. I'm wondering where you are on that line of thinking as the stock continues to kind of drift lower.

    所以上個季度,當我問到這個問題時,您似乎暗示您可能會在某個時候給出它。我想知道,隨著股價持續走低,您對此有何看法。

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. So Tim, thanks for the question. What we tried to do at the J.P. Morgan Conference, and I think everyone is aware, is really highlight the confidence we have in our long term by focusing on the strength of the pipeline.

    是的。所以提姆,謝謝你的提問。我想大家都知道,我們在摩根大通會議上試圖透過專注於通路實力來真正凸顯我們對長期發展的信心。

  • I commented in our script that we have over 20 new products that we see coming over the next few years, almost all of which have blockbuster potential. And if you look at the totality of those as you look forward, this really makes up the bulk of what is the $50 billion-plus potential we see out in the early to mid-2030s.

    我在我們的腳本中提到,我們預計未來幾年將推出 20 多種新產品,幾乎所有產品都具有轟動效應。如果你把這些因素綜合起來看,你會發現這實際上構成了我們在 2030 年代初期到中期所看到的 500 多億美元潛力的大部分。

  • So I think that gives people a sense of what we're doing. Whether we go beyond that to give specific line-by-line guidance, as of right now, we do not have a plan to do that, but we are continuing to evaluate it. And we'll take a sense of where the majority investors have a view on that. Many people, frankly, disagree with you that we've heard from.

    所以我認為這讓人們了解我們正在做的事情。我們是否會進一步提供具體的逐行指導,截至目前,我們還沒有這樣做的計劃,但我們正在繼續評估它。我們將了解大多數投資者對此的看法。坦白說,我們聽到很多人不同意你的觀點。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thanks, Tim. Next question, please, Dustin.

    偉大的。謝謝,蒂姆。達斯汀,請問下一個問題。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    路易莎·赫克托(Luisa Hector),貝倫貝格(Berenberg)。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Perhaps you could comment on some of the changes we're seeing within the FDA and the HHS, particularly with reference to vaccines and the outlook there.

    也許您可以評論我們在 FDA 和 HHS 內部看到的一些變化,特別是關於疫苗及其前景的變化。

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

    Dean Li - Executive Vice President and President, Research Laboratories

  • Yeah. This is Dean. Thanks for the question. In specific relationship to the FDA, I would just say we've listed programs with imminent PDUFA dates like clesrovimab, subcu KEYNOTE-689. And all of our communications have suggested that they're all on track.

    是的。這是迪恩。謝謝你的提問。具體到與 FDA 的關係,我只想說,我們列出了即將達到 PDUFA 日期的項目,例如 clesrovimab、subcu KEYNOTE-689。我們所有的溝通都顯示一切進展順利。

  • There's actually very active dialogue with FDA programs with near-term filings including enlicitide and also, for example, WINREVAIR as we speak about potential label changes. What we can't comment is, is the mid to long-term sort of impact of the many FDA personnel transitions.

    實際上,我們正​​在與 FDA 就近期提交的申請項目進行非常積極的對話,包括 enlicitide 以及例如 WINREVAIR,我們正在談論潛在的標籤變化。我們無法評論的是,FDA 人員變動所帶來的中長期影響。

  • And we'll just have to see and be very watchful for that. But in the imminent PDUFA dates and in the active dialogues that we've had on programs that we've been talking to them for the last year, 1.5 years, we haven't seen any shift in timelines.

    我們必須觀察並密切注意這一點。但在即將到來的 PDUFA 日期以及我們在過去一年半與他們就專案進行的積極對話中,我們尚未看到時間表有任何變化。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thanks, Luisa. Next question, please, Dustin.

    偉大的。謝謝,路易莎。達斯汀,請問下一個問題。

  • Operator

    Operator

  • Vamil Divan, Guggenheim Securities.

    瓦米爾·迪萬,古根漢證券公司。

  • Vamil Divan - Analyst

    Vamil Divan - Analyst

  • Maybe again, just more macro big-picture questions here. I have two like. So one, you mentioned business development is top priority. I'm wondering if you could just sort of comment on the sort of input for business development now, given all the macro volatility and the unknowns on tariffs, et cetera, just Merck's willingness to do larger sort of deal or maybe a more meaningful size bolt-on deal. And also from the seller side, is there willingness to sell it to? Any insight there would be appreciated.

    或許,這裡只是更多宏觀的大局問題。我有兩個喜歡的。首先,您提到業務發展是重中之重。我想知道您是否可以評論一下現在對業務發展的投入,考慮到所有的宏觀波動和關稅等未知因素,默克是否願意進行更大規模的交易,或者更有意義的附加交易。從賣方角度來看,是否有出售意願?任何見解都將不勝感激。

  • And the second topic that comes up a lot now is for the potential for international reference pricing of some sort, where US prices may get tied in some way to ex US prices. Obviously, a lot of unknowns there, too, but just curious if you can comment on your perspective on that or any insights you might have on that potentially becoming a reality.

    現在經常出現的第二個話題是某種國際參考定價的可能性,其中美國價格可能以某種方式與美國以外的價格掛鉤。顯然,這裡也有很多未知數,但我只是好奇您是否可以評論一下您對此的看法,或者您對這可能成為現實的任何見解。

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. No, thanks, Vamil, for the questions. On the first question, the macro environment and what does it mean from a business development perspective? Maybe just to provide context, to be clear, our focus on business development is unchanged. Our desire and belief that we need to continue to identify new science-based opportunities to continue to build on the pipeline is unchanged.

    是的。不,謝謝 Vamil 提出的問題。第一個問題,宏觀環境從業務發展角度來說意味著什麼?也許只是為了提供背景訊息,明確地說,我們對業務發展的關注沒有改變。我們的願望和信念是,我們需要繼續尋找新的基於科學的機會來繼續建立管道,這一點沒有改變。

  • And so our strategy continues. As we look at the environment, I mean, clearly, what's happening does make it more complex to get things done because the uncertainty, everyone is wrestling with. And we are doing everything we can to make sure we reflect that as we think about value and what we are willing to pay in that environment.

    我們的戰略仍在繼續。當我們觀察環境時,我的意思是,顯然,正在發生的事情確實使完成事情變得更加複雜,因為每個人都在努力應對不確定性。我們正在盡一切努力確保在考慮價值以及我們願意在那種環境下支付的價格時反映這一點。

  • But it's not stopping us from being aggressive and wanting to move forward and do deals. As it relates to the sellers, I would say that we continue to see, at least in the conversations we've had, a little bit of a disconnect between what is the reality of the market that the sellers face and what is the expectation for value that they have.

    但這並沒有阻止我們積極進取、繼續前進並達成交易。至於賣家,我想說,至少在我們進行的對話中,我們繼續看到賣家面臨的市場現實與他們對價值的期望之間存在一些脫節。

  • I don't think they are fully yet aligned to the realities of where we are today. And so we continue to move forward, but that is kind of the environment we see and -- but I am confident that you are going to see us get some stuff done as we move forward because we've got things in the queue that we're looking for.

    我認為它們還沒有完全符合我們今天的現實。因此,我們會繼續前進,但這就是我們所看到的環境——但我相信,隨著我們前進,你會看到我們完成一些事情,因為我們已經把需要的東西排在了隊列中。

  • And then as it relates to the most favored nations question, I don't want to speculate on what the administration might do specifically. But I would say, generally, we recognize -- I recognize and I think the industry recognizes that the price differential that exists between the United States and the rest of the world on -- for our innovative medicines needs to be addressed. We are open and willing to work with the administration to do that.

    至於最惠國待遇問題,我不想猜測政府具體會採取什麼行動。但我想說,總的來說,我們認識到——我認識到,而且我認為業界也認識到,美國和世界其他國家之間存在的創新藥物價格差異需要解決。我們願意與政府合作實現這一目標。

  • And I think it's important that I would highlight a few areas that we see as kind of the focal areas. First and foremost, we, as an industry and [company] (corrected by company after the call), continue to believe PBM reform would be one important step. If you look at the fact that over $0.50 of every dollar goes to somewhere in the middle, so the discoverers and manufacturers only get less than half of every dollar. If we could find a way to bring more of that back to the patient at the pharmacy counter, that could meaningfully reduce prices in the US. That would be an important step to lessen the differential.

    我認為有必要強調我們認為的幾個重點領域。首先,作為產業和 [公司](電話會議後公司更正),我們仍然相信 PBM 改革將是重要的一步。如果你看一下這個事實,每美元中有超過 0.50 美元流向了中間某個地方,那麼發現者和製造商只能獲得不到一半的美元。如果我們能夠找到一種方法,將更多的藥品返還給藥房櫃檯的患者,那麼就可以顯著降低美國的價格。這將是縮小差距的重要一步。

  • And then secondly, and I agree with there was -- I think you probably saw the recent commentary from some of my peers, but I agree with the fact that we have to continue to encourage foreign governments to understand that they need to give fair value for the innovation we bring and that they give access to their patients so that we can bring the medicines to them and it's at prices that reward us for the risk and the innovation that we have. And I think that that's also an important element.

    其次,我同意這一點——我想你可能看到了我一些同行最近的評論,但我同意我們必須繼續鼓勵外國政府理解,他們需要對我們帶來的創新給予公平的價值,並讓他們的病人能夠獲得藥品,這樣我們就可以把藥品帶給他們,而且價格要能獎勵我們承擔的風險和做出的創新。我認為這也是一個重要因素。

  • We are spending time individually as a company and along with our other industry peers promoting that point everywhere we can around the world, and we will continue to do that. And then as I mentioned, lastly, we are very open to working with the administration to find solutions to address this.

    我們公司自己以及行業內的其他同行都在花時間在世界各地宣傳這一點,我們將繼續這樣做。最後,正如我所提到的,我們非常願意與政府合作,尋找解決這個問題的方案。

  • But the important thing is we need to make sure we protect access in the United States and we protect the innovation engine we have, the jobs it creates and the strength of this industry as an important contributor to the United States.

    但重要的是,我們需要確保保護美國的准入,保護我們擁有的創新引擎、它所創造的就業機會以及該行業作為美國重要貢獻者的實力。

  • We don't want to lose the leadership we have in this important field. And that's what we're trying to advocate for as we work with the administration.

    我們不想失去在這個重要領域的領導地位。這正是我們在與政府合作時努力倡導的。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thank you, Vamil. Next question, please.

    謝謝你,瓦米爾。請回答下一個問題。

  • Operator

    Operator

  • Chris Schott, J.P. Morgan.

    摩根大通的克里斯·肖特。

  • Chris Schott - Analyst

    Chris Schott - Analyst

  • Just had one question and just a quick follow-up on an earlier one. On the question, can you just talk about GARDASIL and the potential to move to a single dose in the US? I'd just be interested in your thoughts on the potential for a CDC recommendation here and Merck's ability to potentially adjust price in such an outcome.

    我只有一個問題,只是想快速跟進一下之前的問題。關於這個問題,您能否談談 GARDASIL 以及在美國轉向單劑量接種的可能性?我只是想知道您對 CDC 提出建議的可能性以及默克公司在這種結果下調整價格的能力的看法。

  • My follow-up was just on the manufacturing and kind of longer-term tariff-mitigation efforts. Should we let those efforts mostly focused on new products and pipeline? Or is there also an ability to address legacy products such as KEYTRUDA with those longer-term efforts?

    我的後續問題只是關於製造業和長期關稅減免措施。我們是否應該將這些努力主要集中在新產品和新通路上?或者是否也有能力透過這些長期努力來解決 KEYTRUDA 等遺留產品的問題?

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

    Dean Li - Executive Vice President and President, Research Laboratories

  • Yeah. Chris, thanks for the question. Let me address the GARDASIL reduced dosing. And I think you're specifically referring to ACIP and potential deliberations in relationship to reduce dosing. And I don't want to speculate what the ACIP may do.

    是的。克里斯,謝謝你的提問。讓我來談談 GARDASIL 的減少劑量。我認為您特別指的是 ACIP 以及與減少劑量相關的潛在討論。我不想猜測 ACIP 會做什麼。

  • But I just want to emphasize that we are extremely confident in the safety and efficacy of the GARDASIL-9 and in the dosing regimen. And I would just emphasize, we have had clear firm, consistent, and recent guidance from the FDA on what would require for the licensure of a reduced dosing or a single dose.

    但我只想強調,我們對 GARDASIL-9 的安全性和有效性以及給藥方案非常有信心。我想強調的是,我們已經從 FDA 獲得了明確、堅定、一致且最新的指導,說明減少劑量或單劑量許可的要求。

  • They are very clear on the high evidentiary standard. They point out to us that it must be efficacy against disease endpoints, not just infections. You must have data in males and females, recognizing that HPV-related head and neck in males is actually greater here in the United States than cervical cancer.

    他們非常清楚高證據標準。他們向我們指出,它必須對疾病終點有效,而不僅僅是感染。您必須擁有男性和女性的數據,並認識到在美國男性中與 HPV 相關的頭頸部癌實際上比子宮頸癌更高。

  • They emphasize to us high statistical bar and they emphasize to us long-term durability of protection. The FDA is incredibly up-to-date and aware of the limitations of existing trials, and none meet the criteria for them to have a label change.

    他們向我們強調高統計標準,並向我們強調保育的長期持久性。FDA 非常了解並意識到現有試驗的局限性,並且沒有一項試驗符合更改標籤的標準。

  • So there appears to be a disparity between the stringent clinical requirements outlined by the FDA and some of the proposals that are in front of the ACIP. So what we are hopeful is that there will be a robust discussion and interrogation in a public setting in relationship to the clear disparity in the evidentiary standard set by us -- set by the FDA to us and the options that the ACIP is considering. Caroline, did you want to answer the other question?

    因此,FDA 概述的嚴格臨床要求與 ACIP 面臨的一些提案之間似乎存在差異。因此,我們希望能夠在公開場合就我們設定的證據標準(FDA 為我們設定的)與 ACIP 正在考慮的選項之間的明顯差異進行深入的討論和質詢。卡洛琳,你想回答另一個問題嗎?

  • Caroline Litchfield - Executive Vice President and Chief Financial Officer

    Caroline Litchfield - Executive Vice President and Chief Financial Officer

  • Yeah. So in terms of should the ACIP look towards any different type of dosing regimen, we stand firmly behind the value that GARDASIL brings in preventing certain HPV-related cancers. And we will be looking to ensure that, that cost effectiveness is understood as we appropriately price the vaccine. Did you want to touch then on the second question, Rob, which is the manufacturing and the longest --

    是的。因此,無論 ACIP 是否應該考慮任何不同類型的給藥方案,我們都堅定地支持 GARDASIL 在預防某些 HPV 相關癌症方面所帶來的價值。我們將確保在為疫苗合理定價時能夠理解成本效益。那麼,羅布,你想談第二個問題嗎?那就是製造,也是最長的--

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Oh, yeah. Sorry about that. I was enjoying your answer so much. I forgot the other question. Sorry about that.

    哦,是的。很抱歉。我非常喜歡你的回答。我忘了另一個問題。很抱歉。

  • Now Chris, to your question about the manufacturing, it's really both. So clearly, we are very focused on new products, some of which we already have in the United States, others we're going to be moving to bring them to the United States. But we also are very focused on KEYTRUDA.

    克里斯,對於你關於製造業的問題,實際上兩者兼而有之。顯然,我們非常關注新產品,其中一些產品我們已經在美國上市,其他產品我們正準備將它們引入美國。但我們也非常關注 KEYTRUDA。

  • As you probably can surmise, our biggest exposure is KEYTRUDA in the near term, but I feel very good that as we sit here today with -- as I mentioned, the fact that we have basically on-hand inventory in the United States to protect us through all of 2025. And then we've taken steps to be prepared both from a drug substance and drug product as we move into 2026 and 2027.

    您可能已經猜到了,我們近期最大的風險敞口是 KEYTRUDA,但我很高興今天我們坐在這裡——正如我提到的,我們在美國基本上有現成的庫存,可以保護我們到 2025 年全年。然後,我們已採取措施,為進入 2026 年和 2027 年做好藥物成分和藥物產品的準備。

  • We're as well-positioned as you could be through both the short-term actions on inventory as well as securing additional manufacturing in the United States, both through contract manufacturers, and then we are already underway to go to our own internal manufacturing.

    我們已做好充分準備,既可以採取短期庫存行動,也可以透過合約製造商確保在美國進行額外的製造,然後我們已經開始轉向自己的內部製造。

  • So we're as well-positioned on KEYTRUDA as you can be. Obviously, we have to wait and see what the tariffs are. So I don't want to speak to the specific implications because it depends on the form they take. But I think we're positioned on both KEYTRUDA and the new products.

    因此,我們在 KEYTRUDA 方面已做好了盡可能好的準備。顯然,我們必須拭目以待,看看關稅是多少。所以我不想談論具體的含義,因為這取決於它們採取的形式。但我認為我們對 KEYTRUDA 和新產品都有所定位。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thank you, Chris. Next question, please.

    謝謝你,克里斯。請回答下一個問題。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    德意志銀行的詹姆斯辛 (James Shin)。

  • James Shin - Analyst

    James Shin - Analyst

  • One for Rob. Rob, you've already disclosed a healthy amount of US investments. But is there a need for more -- or room for more US CapEx and is it pending US tax reform? And then one for Dean. Has the recent PD-1 VEGF data set made you and your team want to accelerate or maybe allocate more resources to LM-299's development?

    一個給羅布。羅布,你已經披露了大量美國投資。但是,是否需要更多——或者說有更多美國資本支出的空間,並且是否等待美國稅制改革?然後還有一本給 Dean。最近的 PD-1 VEGF 資料集是否讓您和您的團隊想要加速或為 LM-299 的開發分配更多資源?

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. Thanks for the question. So as we sit here today, as we mentioned, between the $12 billion we've done plus the $9 billion-plus we have underway. So we're going to be looking at north of $21 billion since 2018 as we look over the next few years. I actually think, over time, you're going to see that grow as we continue to -- because that's based on the firm decisions we've already made.

    是的。謝謝你的提問。因此,正如我們所提到的那樣,今天我們坐在這裡,我們已經完成了 120 億美元,加上正在進行的 90 多億美元。因此,展望未來幾年,我們預計自 2018 年以來該數字將超過 210 億美元。我實際上認為,隨著時間的推移,你會看到它會繼續增長——因為這是基於我們已經做出的堅定決定。

  • So that doesn't include an expectation that's actually firm decisions. And as we think about bringing back manufacturing, I think you actually will see that number grow. The tax environment, obviously, we have to think holistically about all of this, but it is not going to affect how we think about investment. We think we can both do the necessary investments and manage our tax position quite effectively.

    因此這並不包括實際上堅定決定的期望。當我們考慮恢復製造業時,我認為你實際上會看到這個數字成長。顯然,我們必須全面考慮稅收環境,但這不會影響我們對投資的看法。我們認為我們既可以進行必要的投資,又可以相當有效地管理我們的稅務狀況。

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

    Dean Li - Executive Vice President and President, Research Laboratories

  • Yeah. In relationship to the PD-1 VEGF question, I think you're referring to the -- I think it's the HARMONY 2 and 6 sort of readout that's come up. One of the things that's actually very consistent that I think the field is looking for is whether any advancement in relationship PFS over a single PD-1 can be translated to an OS and whether something that's in a China-only study can be done globally. Having said that, we embrace the advancements in the field. And we think KEYTRUDA sets a high bar with 41 indications across 18 tumor types.

    是的。關於 PD-1 VEGF 問題,我認為您指的是——我認為是出現的 HARMONY 2 和 6 類型的讀數。我認為該領域一直在尋找的一個問題是,與單一 PD-1 相關的 PFS 的任何進展是否可以轉化為 OS,以及僅在中國進行的研究是否可以在全球範圍內進行。話雖如此,我們還是歡迎該領域的進步。我們認為 KEYTRUDA 針對 18 種腫瘤類型的 41 種適應症設定了很高的標準。

  • As you note, we have our own PD-1 VEGF, and we will gate our decisions in relationship to this as our data and other data evolves. But as you point out, we believe strongly that we are the advantaged owner given clinical expertise, extensive data generated, and that in some sense, we have both the KEYTRUDA and a LEAP playbook, and we would intend to move with speed and vigor.

    正如您所說,我們有自己的 PD-1 VEGF,並且隨著我們的數據和其他數據的發展,我們將根據此做出決定。但正如您所指出的,我們堅信,鑑於臨床專業知識、生成的大量數據,我們是具有優勢的所有者,並且從某種意義上說,我們同時擁有 KEYTRUDA 和 LEAP 劇本,我們打算快速而有力地採取行動。

  • Most importantly -- or equally important is should that PD-1 VEGF show that OS benefit, we also have an advantage of having unique portfolio agents that have clear potential for combined ability. So we are looking at our own data and the data in the field as we make those decisions.

    最重要的是——或者同樣重要的是,如果 PD-1 VEGF 顯示出 OS 優勢,那麼我們還擁有擁有明顯組合潛力的獨特組合藥物的優勢。因此,我們在做出這些決定時會查看我們自己的數據和現場數據。

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • And maybe I would just want to add that should the bispecific be successful, I think you can expect that the impact to us, because of -- this is likely to come, frankly, probably post the LOE of KEYTRUDA is pretty small. If you look across non-small cell lung cancer where potentially the competitor could be coming by that time, will only be mid-teens of our business, max. And remember, we are working very diligently to convert people to the earlier-stage setting. And as we do so, they don't have an indication there.

    也許我只想補充一點,如果雙特異性抗體成功了,我想你可以預料到它對我們的影響,因為——坦白說,這很可能在 KEYTRUDA 的 LOE 之後發生,而且影響非常小。如果你看非小細胞肺癌,到那時潛在的競爭對手可能只會占我們業務的十幾分之一。請記住,我們正在非常努力地讓人們轉向早期階段的環境。當我們這樣做的時候,他們卻沒有任何跡象。

  • So from that perspective, the risk to us is minimal. But I think what I'd really want to emphasize, the opportunity is significant. And I think that's the point that Dean's trying to make. I think this could be, frankly, a really good thing for [our company] (corrected by company after the call) long term.

    因此從這個角度來看,我們面臨的風險很小。但我認為我真正想強調的是,這個機會意義重大。我認為這就是 Dean 想要表達的觀點。坦白說,我認為從長遠來看這對[我們公司](電話會議後公司更正)來說可能是一件好事。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thanks, James. Next question, please.

    偉大的。謝謝,詹姆斯。請回答下一個問題。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉 (Steve Scala),TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Regarding GARDASIL growth slow down globally, which seems to be a new disclosure, what new information emerged since Q1 when the company spoke to growth in each and every market? Is there still a line of sight to $11 billion, which was repeated on the Q4 call? And is 2025 still the trough year?

    關於 GARDASIL 全球成長放緩,這似乎是一個新的披露,自第一季公司談到每個市場的成長以來,出現了哪些新資訊?是否仍有望達到第四季電話會議上重申的 110 億美元目標?2025年仍是低谷年嗎?

  • Caroline Litchfield - Executive Vice President and Chief Financial Officer

    Caroline Litchfield - Executive Vice President and Chief Financial Officer

  • Thank you, Steve, for the question. First, the information that we're providing with regard to the opportunities to grow GARDASIL outside of China is not new. What we are highlighting, however, is a very effective execution by our colleagues in Japan of a catch-up cohort program that ends on the 31st of March of this year.

    謝謝史蒂夫提出的問題。首先,我們提供的有關在中國以外地區種植 GARDASIL 的機會的資訊並不新鮮。然而,我們要強調的是,我們在日本的同事非常有效地執行了補種隊列計劃,該計劃將於今年 3 月 31 日結束。

  • And as a result of that ending, we expect our sales in Japan to reflect the primary age cohort and therefore be reduced from quarter two onwards to what we have achieved over the prior quarters. As we look to GARDASIL globally this year, we expect China to be a headwind.

    由於這一結束,我們預計我們在日本的銷售額將反映主要年齡段,因此從第二季度開始將下降到前幾季的水平。當我們今年放眼全球 GARDASIL 時,我們預計中國將成為阻力。

  • We had said previously with regards to China, we will assess do we or do we not ship further product this year at the midpoint of this year? And we will do that assessment at the midpoint of this year, however, expect given the current dynamics in China that is -- it is not so likely that we will ship further product in China.

    我們之前曾說過,關於中國,我們將在今年年中評估今年是否還會運送更多產品?我們將在今年中期進行評估,但是,考慮到中國目前的情況,我們不太可能在中國運送更多產品。

  • And that is actually an outcome that is incorporated into the midpoint of our guidance. All of that said, we do expect strong growth, excluding China, strong double-digit we've achieved in the first quarter. And we expect continued strong growth as we go through the remainder of the year.

    這實際上是納入我們指導中點的結果。儘管如此,我們確實預計會出現強勁成長,不包括中國,我們在第一季實現了強勁的兩位數成長。我們預計今年剩餘時間將持續保持強勁成長。

  • In terms of the longer-term guidance, we did withdraw the $11 billion target last quarter, given the fact that China was an important part of the achievement of that $11 billion. Our company remains focused and on the ground in China to maximize the opportunity and maximize the launch in males, while we're working across the entirety of the world to protect many more lives from HPV-related cancers and drive growth for our business as we move forward.

    就長期指導而言,考慮到中國是實現 110 億美元目標的重要組成部分,我們上個季度確實撤回了 110 億美元的目標。我們公司將繼續專注於中國本土市場,以最大程度地抓住機遇,最大限度地在男性中推廣該產品,同時,我們也在全世界範圍內努力保護更多人的生命免受 HPV 相關癌症的侵害,並推動我們業務的增長。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thanks, Steve. Next question, please.

    偉大的。謝謝,史蒂夫。請回答下一個問題。

  • Operator

    Operator

  • Alex Hammond, Wolfe Research.

    沃爾夫研究公司的亞歷克斯·哈蒙德。

  • Alex Hammond - Analyst

    Alex Hammond - Analyst

  • So during the ACIP meeting, you spoke about adjusting the wording for the HPV recommendation from 11 to 12 years old, but eligible at 9 to recommendation to 9 to 12. That should be voted on at the June meeting. How important do you see this wording update to an impact to US sales? And from your doctor checks, do you see the broader recommendation being a material tailwind?

    因此,在 ACIP 會議期間,您談到了調整 HPV 建議的措辭,從 11 歲到 12 歲,但符合 9 歲接種條件,建議改為 9 到 12 歲。此事應在六月的會議上進行表決。您認為此措辭更新對美國銷售的影響有多大?從醫生的檢查來看,您是否認為更廣泛的建議會帶來實質的順風?

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. Thanks for the question. As we look at what is the potential recommendation that could come in June, to your point, it appears that we could see them extend the recommendation to nine years and old and up. We actually view that as a very important and positive development because of the fact that, one, as you look at adolescents who are being vaccinated in the early teens, to the extent that they will need multiple vaccinations, it's harder to get the fulfillment of the full vaccination schedule. If you started nine, we're more apt to see people complete the schedule, which is a positive.

    是的。謝謝你的提問。當我們研究 6 月可能出台的建議時,正如您所說,我們似乎可以看到他們將建議擴大到 9 歲及以上。我們實際上認為這是一個非常重要和積極的發展,因為,首先,當你看到十幾歲就開始接種疫苗的青少年時,他們會需要多次接種疫苗,因此完成整個疫苗接種計劃會更加困難。如果你開始九個,我們更有可能看到人們完成計劃,這是一件正面的事。

  • And then in addition, at nine years old, you're at a time when there's not a lot of other vaccines happening -- vaccinations happening, so there can be a focus on the GARDASIL vaccination at a time when it's, I think, easier for the family to prioritize and focus on it. So we do see it as a positive. I wouldn't view it as a big upside to the US.

    此外,在孩子九歲的時候,還沒有太多其他疫苗可以接種,所以可以把重點放在 GARDASIL 疫苗接種上,我認為,這個時候家人更容易優先考慮並集中精力接種。所以我們確實認為這是一件正面的事。我不認為這對美國有什麼大好處。

  • We've kind of always viewed that this was an evolution that will be important. And in fact, while this will be an important recommendation, it's already approved in that age cohort today. And in fact, you do see vaccinations happening. This recommendation just reinforces it because it's coming from the ACIP.

    我們一直認為這是一個重要的演進。事實上,雖然這是一項重要的建議,但它今天已在該年齡組中獲得批准。事實上,你確實看到了疫苗接種的發生。這項建議來自 ACIP,因此進一步強化了這一點。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Great. Thanks, Alex. Next question, please.

    偉大的。謝謝,亞歷克斯。請回答下一個問題。

  • Operator

    Operator

  • Umer Raffat, Evercore.

    烏默·拉法特(Umer Raffat),Evercore。

  • Umer Raffat - Analyst

    Umer Raffat - Analyst

  • I have a simple one, perhaps, if I may. Rob, are you intending to keep the IP for KEYTRUDA subcu here in US rather than Ireland as we head towards a potential approval?

    如果可以的話,我有一個簡單的。羅布,在我們即將獲得批准的過程中,您是否打算將 KEYTRUDA 的智慧財產權保留在美國而不是愛爾蘭?

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. Actually, I don't think we've ever disclosed where the IP is for subcu. And I don't want to get into a discussion of that. So I think I would prefer not to speak to that just for proprietary reasons.

    是的。實際上,我認為我們從未透露過 subcu 的 IP 在哪裡。我不想討論這個。因此,我認為出於專有原因我不願意談論這個問題。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thanks, Umer. Next question, please.

    謝謝,烏默爾。請回答下一個問題。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    Akash Tewari,傑富瑞。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • So a few admittedly unfair questions on tariffs. One, is a 25% tariff a reasonable expectation? Or do you expect the headline number to be higher? What is your confidence that if they do get announced, they'll at least be administered thoughtfully, whether it's gradual implementation or expedited regulatory process to move manufacturing to the US quickly?

    因此,我承認有幾個關於關稅的問題不公平。一、25%的關稅是合理預期嗎?或者您預期整體數字會更高?如果這些措施真的宣布,您是否有信心至少會經過深思熟慮地實施,無論是逐步實施還是加快監管流程以迅速將製造業轉移到美國?

  • And then finally, let's say, the end of being 25%, could the impact to Merck with reasonable mitigation efforts be in the kind of single-digit range on earnings on a percent basis?

    最後,假設最終比例為 25%,那麼透過合理的緩解措施,對默克公司的影響是否會在百分比基礎上達到個位數的範圍內?

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. No, I appreciate the question. I don't want to speculate on what the tariffs could be because we need to see what the language is from the administration. I think the important point is, as I previously stated, we have taken the steps both in terms of inventory management for the short term as well as starting to reposition manufacturing for the medium and long term.

    是的。不,我很感謝你提出這個問題。我不想猜測關稅是多少,因為我們需要看看政府的措詞。我認為重要的一點是,正如我之前所說,我們已經採取了短期庫存管理措施,並開始重新定位中長期製造業。

  • But I think we are well-positioned under most scenarios that they could come through. But the specifics you're looking for, I don't want to speculate because we need to see what it is.

    但我認為,在大多數情況下,我們都處於有利地位。但對於您正在尋找的具體信息,我不想進行推測,因為我們需要了解它是什麼。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thanks, Akash. Next question, please.

    謝謝,阿卡什。請回答下一個問題。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    富國銀行的 Mohit Bansal。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • I have a question regarding the BD strategy. What we have seen lately is that you have acquired a bunch of assets from China. I mean like I completely understand the cost effectiveness of them. But at the same time, it doesn't seem like they are innovative area, right? I mean all sites you are the first mover here.

    我有一個關於 BD 策略的問題。我們最近看到的是,你們從中國收購了大量資產。我的意思是我完全理解它們的成本效益。但同時,它們似乎不是創新領域,對嗎?我的意思是,在所有網站上,您都是這裡的先驅。

  • The TROP2 to Lp(a) and even VEGF PD-1s. So why doesn't it feel like more like a company like Merck is chasing the frontrunners here versus trying to be something -- do something innovative? Would love to understand the thought process there.

    TROP2 至 Lp(a) 甚至 VEGF PD-1s。那麼,為什麼感覺像默克這樣的公司並不像是在追逐領跑者,而是在嘗試做些什麼——做一些創新的事情呢?很想了解那裡的思考過程。

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

    Dean Li - Executive Vice President and President, Research Laboratories

  • Yeah. I'll take that question first. So first of all, I would remind us that I would sit there and I would consider the Acceleron purchase and WINREVAIR as bringing a front-leading molecule. I would also sit there and consider that the move to TL1A in Tulisokibart would be that as well. And I would reemphasize my excitement of our acquisition of EyeBio in relationship to wet AMD and diabetic macular edema.

    是的。我先回答這個問題。因此,首先,我要提醒我們,我會坐在那裡,我會考慮收購 Acceleron 和 WINREVAIR,因為它們帶來了領先的分子。我也會坐在那裡考慮將 Tulisokibart 的 TL1A 遷移到那裡也是一樣。我想再次強調,我對我們收購 EyeBio 的興奮之情,因為它與濕性 AMD 和糖尿病黃斑水腫有關。

  • I should also emphasize that when you talk about certain compounds, let's say, an Lp(a) or GLP, I would remind you also that we believe that we have an ambition to have the first and best oral PCSK9. It will be first to market. We think it will be the most effective. We're very confident in the cardiovascular outcomes, but we're also very confident in its ability to combine with certain agents. So when you look at some of the BD, I might not look at it as in isolation of the rest of the pipeline.

    我還應該強調的是,當您談論某些化合物時,例如 Lp(a) 或 GLP,我還要提醒您,我們相信我們的目標是擁有第一個也是最好的口服 PCSK9。它將率先進入市場。我們認為這將是最有效的。我們對心血管治療結果非常有信心,但我們對其與某些藥物結合的能力也非常有信心。因此,當您查看某些 BD 時,我可能不會將其視為與管道的其餘部分隔離。

  • I think that there are certain combinations that would be incredibly innovative that would require a combination, but some of the innovation of the base of that innovation comes from our company, and it's a coordinated one pipeline external internal pipeline fusing into a final product. Rob, did you want to add anything?

    我認為某些組合會具有令人難以置信的創新性,需要進行組合,但這種創新基礎的一些創新來自我們公司,它是一個協調的管道,外部內部管道融合成最終產品。羅布,你還有什麼要補充的嗎?

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Yeah. Maybe just to reinforce, I think, a couple of points. We've been, I think, very balanced. Dean gave some great examples of where we are first in class and, frankly, best in class. We're also looking at other strategies where we might not be first, but we still think we can be best in class.

    是的。我認為也許只是為了強調幾點。我認為我們已經非常平衡了。迪恩舉了一些很好的例子,說明我們在哪些方面是班上第一,坦白說,也是班上最好的。我們也在研究其他策略,雖然我們可能不是第一,但我們仍然認為我們可以做到最好。

  • So I think you have to look at the total of the portfolio and not just the most recent three deals we've done. And I actually think you'll see us continue to do a range of opportunities which cover the full spectrum. Because as we look at it, it's about how do we position ourselves for growth. And in some cases, in some of these therapeutic areas, we think there's still unmet need. I mean Dean highlighted a little bit, but obesity, there's an opportunity for a next wave.

    所以我認為你必須看整個投資組合,而不僅僅是我們最近完成的三筆交易。事實上,我認為你會看到我們繼續提供一系列涵蓋全方位的機會。因為從我們的角度來看,這關乎我們如何定位自己以實現成長。在某些情況下,我們認為在某些治療領域仍有未滿足的需求。我的意思是,迪恩強調了一點,但肥胖症,是下一波浪潮的機會。

  • Depending on what comes with the PD-1 VEGF, that could be a next wave where, frankly, when you combine it with other agents we have, we could lead as well. So I don't think it's a fair characterization, and I would urge you to think more towards in terms of the total portfolio.

    根據 PD-1 VEGF 的進展,這可能是下一波浪潮,坦白說,當你將它與我們擁有的其他藥物結合時,我們也能引領潮流。因此我認為這不是一個公平的描述,我建議您從整體投資組合的角度進行更多的思考。

  • Peter Dannenbaum - Senior Vice President, Investor Relations

    Peter Dannenbaum - Senior Vice President, Investor Relations

  • Thank you very much, Mohit. I think that puts us past the hour. So very much appreciate your time and attention this morning. And if you have any additional questions, please reach out to IR. Thank you all very much.

    非常感謝,Mohit。我認為我們已經超過這個時間了。非常感謝您今天上午的時間和關注。如果您還有其他問題,請聯絡 IR。非常感謝大家。

  • Rob Davis - Chairman and Chief Executive Officer

    Rob Davis - Chairman and Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • That concludes today's conference. Thank you for participating. You may disconnect at this time.

    今天的會議到此結束。感謝您的參與。您現在可以斷開連線。