默克藥廠 (MRK) 2024 Q4 法說會逐字稿

Thank you for standing by.

感謝您的支持。

Welcome to the Merck and Company Q4 sales and earnings conference call.

歡迎參加默克公司第四季銷售和收益電話會議。

(Operator Instructions) This call is being recorded.

（操作員指示）此通話正在錄音。

If you have any objections, you may disconnect at this time.

如果您有任何異議，此時您可以斷開連接。

I would now like to turn the call over Mr. Peter Dannenbaum, Senior Vice President, Investor Relations.

現在我想將電話轉給投資者關係資深副總裁 Peter Dannenbaum 先生。

Sir, you may begin.

先生，您可以開始啦。

Thank you, Shirley, and good morning everyone.

謝謝你，雪莉，大家早安。

Welcome to Merck's fourth-quarter 2024 conference call.

歡迎參加默克 2024 年第四季電話會議。

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 Merck Research Labs.

今天的電話會議發言者將是董事長兼執行長羅布戴維斯 (Rob Davis)；卡洛琳‧利奇菲爾德 (Caroline Litchfield)，財務長；以及默克研究實驗室總裁 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.

在我們開始之前，我想指出的是，我們的 GAAP 結果中有一些項目，例如收購相關費用、重組成本以及我們從非 GAAP 結果中排除的某些其他項目。

There is a reconciliation in our press release.

我們的新聞稿中有一條和解內容。

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.

我還要提醒您，我們今天所做的一些聲明可能被視為符合美國 1995 年私人證券訴訟改革法案安全港條款含義的前瞻性聲明。

Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties.

此類聲明是基於默克管理層當前的看法而做出的，並受重大風險和不確定性的影響。

If our underlying assumptions prove inaccurate or an uncertainty is materialized, actual results may differ materially from those set forth in the forward-looking statements.

如果我們的基本假設被證明不準確或存在不確定性，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 2023 10-K identifies 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.

我們的 SEC 文件（包括 2023 年 10-K 中的第 1A 項）列出了某些風險因素和警告聲明，這些因素和警告聲明可能會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的預測存在重大差異。

Merck undertakes no obligation to publicly update any forward-looking statements.

默克不承擔公開更新任何前瞻性聲明的義務。

During today's call, a slide presentation will accompany our speakers' prepared remarks.

在今天的電話會議中，我們的發言人將以幻燈片形式演示其準備好的發言。

These slides, along with the earnings release, today's prepared remarks, and our SEC filings, are all posted to the Investor Relations section of Merck's website.

這些投影片，連同收益報告、今天的準備好的發言以及我們的美國證券交易委員會文件，都發佈在默克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。

Thanks, Peter.

謝謝，彼得。

Good morning, and thank you for joining today's call.

早安，感謝您參加今天的電話會議。

2024 was another year of significant advancement across our company, and I'm proud of the continued progress we're making in developing and delivering transformative medicines and vaccines to help save and improve lives around the world.

2024 年是我們公司取得重大進步的又一年，我為我們在開發和提供變革性藥物和疫苗以幫助拯救和改善世界各地生命方面取得的持續進展感到自豪。

We are impacting patients on a global scale.

我們正影響著全球的患者。

In fact, in 2024, we reached nearly 0.5 billion people with our medicines and vaccines, including through donations.

事實上，到 2024 年，我們的藥品和疫苗（包括透過捐贈）惠及近 5 億人。

We remain focused on the pursuit of breakthrough science and innovation as the source of sustainable long-term value creation for patients and shareholders.

我們始終專注於追求突破性科學和創新，為患者和股東創造可持續的長期價值。

We're continuing to execute on our strategic priorities.

我們將繼續執行我們的戰略重點。

We're progressing our pipeline, launching important new products that have significant patient benefit and strong commercial potential, advancing key clinical programs in our robust early and late phase pipeline, and augmenting our pipeline through promising business development.

我們正在推進我們的產品線，推出具有重大患者利益和強大商業潛力的重要新產品，推進我們強大的早期和後期產品線中的關鍵臨床項目，並透過有前景的業務發展來擴充我們的產品線。

Our business remains well positioned thanks to the dedication of our talented global team.

由於我們優秀的全球團隊的奉獻，我們的業務保持著良好的地位。

And I'm more confident than ever in our ability to advance patient care, fueling Merck's long-term growth potential.

我比以往任何時候都更有信心，我們有能力提高病患照護水平，並推動默克的長期成長潛力。

Now, turning to our results and outlook.

現在，談談我們的結果和展望。

We delivered strong growth in 2024, reflecting demand for our innovative portfolio, including for KEYTRUDA, which continues to benefit more patients with cancer globally; the successful launch of WINREVAIR; and strong performance of our Animal Health business.

我們在 2024 年實現了強勁成長，反映了對我們創新產品組合的需求，其中包括 KEYTRUDA，它繼續使全球更多癌症患者受益； WINREVAIR 成功發射；以及動物保健業務的強勁表現。

We also saw higher demand and achieved strong sales for GARDASIL outside of China.

我們還看到了 GARDASIL 在中國以外地區的需求增加並取得了強勁的銷售業績。

As we closed out 2024 and entered 2025, the market dynamics for GARDASIL in China have remained challenging.

當我們結束 2024 年並進入 2025 年時，GARDASIL 在中國的市場動態仍然充滿挑戰。

Like many other companies, we’ve seen increased pressure on discretionary consumer spending, including across the vaccine space more broadly; and demand for GARDASIL has not recovered to the level we had expected.

與許多其他公司一樣，我們看到可自由支配的消費者支出壓力越來越大，包括更廣泛的疫苗領域； GARDASIL 的需求尚未恢復到我們預期的水平。

As a result, overall channel inventory remains elevated at above normal levels.

因此，整體通路庫存仍然高於正常水準。

In light of this, and based on further discussions with our commercialization partner, Zhifei, over the past couple of weeks, in particular regarding their most recent financial disclosure and working capital levels, we’ve made the decision to take a new approach and temporarily pause shipments to China beginning this month and through at least mid-year.

有鑑於此，並基於過去幾週與我們的商業化合作夥伴智飛的進一步討論，特別是關於他們最近的財務披露和營運資金水平，我們決定採取新的方式，從本月開始暫停向中國發貨，至少持續到年中。

We believe taking this action now will facilitate a more rapid reduction of inventory and help support the financial position of our important and valued partner.

我們相信，現在採取這項行動將有助於更快地減少庫存，並有助於支持我們重要和寶貴的合作夥伴的財務狀況。

Importantly, we believe China still represents a significant long-term opportunity for GARDASIL given the large number of females, and now males with our recent approval, that are not yet immunized.

重要的是，我們相信中國對 GARDASIL 來說仍然是一個重要的長期機遇，因為中國有大量女性尚未接種疫苗，而最近我們批准了男性也尚未接種疫苗。

And we remain both committed and well-positioned to maximize this potential for the long-term.

我們將繼續致力於並做好充分準備來長期最大限度地發揮這一潛力。

Outside of China, demand for GARDASIL remains robust, and we expect strong growth this year and well into the future.

在中國以外，對 GARDASIL 的需求依然強勁，我們預計今年及未來仍將強勁成長。

Our overall business remains very healthy.

我們的整體業務仍然非常健康。

In fact, irrespective of the performance of GARDASIL in China, we expect the company to deliver strong growth in the second half of this year, as well as in both 2026 and 2027.

事實上，無論 GARDASIL 在中國的表現如何，我們預計該公司將在今年下半年以及 2026 年和 2027 年實現強勁成長。

Longer-term, our confidence in our ability to successfully navigate the KEYTRUDA LOE period is unchanged, which is based on the strength of our pipeline, the excitement we have for our ongoing and upcoming launches of innovative new products, and the commercial opportunity they represent.

從長遠來看，我們對成功度過 KEYTRUDA LOE 時期的能力的信心沒有改變，這是基於我們產品線的實力、我們對正在實施和即將推出的創新新產品的興奮之情，以及它們所代表的商業機會。

Next, I’d like to turn to our research efforts.

接下來我想談談我們的研究工作。

We’re making remarkable progress across multiple therapeutic areas in our late-phase pipeline.

我們在後期研發管線的多個​​治療領域取得了顯著進展。

In the fourth quarter, we announced FDA acceptance for our filing of clesrovimab, our long-acting monoclonal antibody, to protect infants from RSV disease; and positive top-line results from three programs, including for subcutaneous pembrolizumab, for islatravir in combination with doravirine in the treatment of HIV, and for WINREVAIR from the ZENITH trial.

第四季度，我們宣布 FDA 接受了我們的長效單株抗體 clesrovimab 的申請，該抗體用於保護嬰兒免受 RSV 疾病的侵害；以及三個項目取得的正面頂線結果，包括皮下注射 pembrolizumab、islatravir 與 doravirine 聯合治療 HIV 以及 ZENITH 試驗中的 WINREVAIR。

We also executed value-enhancing business development that is both science-led and portfolio informed.

我們也執行了以科學為主導、以投資組合為基礎的增值業務開發。

We licensed promising investigational assets including in oncology with a clinical-stage anti-PD-1/VEGF bispecific antibody from LaNova, and in cardiometabolic with an oral GLP-1 receptor agonist candidate from Hansoh.

我們獲得了有前景的試驗資產的許可，包括腫瘤學領域來自 LaNova 的臨床階段抗 PD-1/VEGF 雙特異性抗體，以及心臟代謝領域來自 Hansoh 的口服 GLP-1 受體激動劑候選藥物。

Merck is anchored today by a robust set of commercial products addressing important medical needs, and we’re rapidly moving to a future with a much more diversified portfolio.

默克如今擁有一系列強大的商業產品來滿足重要的醫療需求，並且我們正在迅速邁向產品組合更加多樣化的未來。

We have amassed an expansive pipeline with tremendous potential to further advance the practice of medicine around the world.

我們已累積了廣泛的產品線，具有巨大的潛力，可以進一步推動世界各地的醫療實踐。

You can expect a steady cadence of data readouts in the coming months and years leading to potential new launches as we seek to bring much needed innovation to patients.

我們致力於為患者帶來急需的創新，您可以期待未來幾個月和數年內資料讀取的穩定節奏，從而帶來潛在的新產品發布。

In fact, we have 20 potential new growth drivers, almost all of which have blockbuster opportunity.

事實上，我們有20個潛在的新成長動力，幾乎所有這些動力都蘊藏著巨大機會。

These include WINREVAIR and CAPVAXIVE, our adult pneumococcal conjugate vaccine, which is now launching in the US, as well as many innovative assets currently in Phase 3 development.

其中包括我們的成人肺炎鏈球菌結合疫苗 WINREVAIR 和 CAPVAXIVE（目前正在美國推出），以及許多目前處於第 3 階段開發階段的創新資產。

Over the past three years, we have nearly tripled the number of assets in late-phase development across a broad range of therapeutic areas and modalities.

在過去三年中，我們在廣泛的治療領域和治療方式中處於後期開發的資產數量增加了近兩倍。

Based on the significant progress, we see over $50 billion of potential revenue opportunity from these programs.

基於重大進展，我們看到這些項目帶來超過 500 億美元的潛在收入機會。

We are positioned for long-term leadership in oncology as we continue to diversify and deepen our pipeline.

隨著我們不斷豐富和深化我們的產品線，我們將在腫瘤學領域佔據長期領導地位。

We are excited about cardiometabolic as a future area of growth, including with our oral PCSK9 inhibitor program where we have important Phase 3 readouts this year.

我們對心臟代謝作為未來的成長領域感到興奮，包括我們的口服 PCSK9 抑制劑項目，今年我們有重要的 3 期讀數。

In immunology, HIV, and ophthalmology, we have opportunities to bring forward first-in-class and/or best-in-class blockbuster medicines.

在免疫學、愛滋病毒和眼科學領域，我們有機會推出一流的和/或一流的重磅藥物。

Further, we expect to benefit from promising programs in our infectious disease and vaccines pipeline, strong growth in our Animal Health business, and many early-phase programs that will enter Phase 2 over the next few years.

此外，我們預計將受益於傳染病和疫苗研發管線中前景看好的項目、動物保健業務的強勁增長以及未來幾年將進入第二階段的許多早期項目。

And we remain well positioned to pursue additional science-driven value-creating business development.

我們仍處於有利地位，可以追求更多以科學為驅動、創造價值的商業發展。

In summary, I have increased confidence in our long-term future.

總而言之，我對我們的長期未來更有信心。

While the rapid change in the Chinese market for GARDASIL has caused a short-term headwind for our company, our overall business is healthy and growing.

雖然中國GARDASIL市場的快速變化為我們公司帶來了短期阻力，但我們的整體業務仍然健康且不斷成長。

We remain strongly positioned to successfully navigate the KEYTRUDA LOE period as we continue to deliver on our purpose of saving and improving lives.

我們仍處於有利地位，能夠成功度過 KEYTRUDA LOE 期，並繼續實現拯救和改善生命的目標。

I want to again recognize the commitment and efforts of our global teams.

我想再次認可我們全球團隊的承諾和努力。

Together, we remain focused on delivering and sustaining value for patients, shareholders, and for all of our stakeholders today and well into the future.

我們將繼續共同致力於為患者、股東以及當前和未來的所有利益相關者創造和維持價值。

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

說完這些，我會把電話轉給卡洛琳。

Thank you, Rob.

謝謝你，羅布。

Good morning.

早安.

As Rob noted, we had another year of strong growth, reflecting continued robust demand for our innovative portfolio and demonstrating the importance of our products to the patients we serve.

正如 Rob 所說，我們又度過了強勁成長的一年，這反映出市場對我們創新產品組合的持續強勁需求，也證明了我們的產品對我們服務的患者的重要性。

Growth was driven by oncology, Animal Health, and new product launches, which more than offset the GARDASIL headwinds in China.

成長主要受腫瘤學、動物保健和新產品發布推動，足以抵消 GARDASIL 在中國的不利影響。

These results demonstrate the strength of our business and give us confidence in our outlook.

這些結果證明了我們業務的實力，並使我們對我們的前景充滿信心。

Our commercial and operational execution enables us to deliver value in the short term while we invest in new innovations and deliver our pipeline for the long-term.

我們的商業和營運執行使我們能夠在短期內創造價值，同時投資新的創新並實現長期的交付。

Now, turning to our fourth-quarter results.

現在，談談我們的第四季業績。

Total company revenues were $15.6 billion, an increase of 7%, or 9% excluding the impact of foreign exchange.

公司總營收為 156 億美元，成長 7%，若不計外匯影響則成長 9%。

The following revenue comments will be on an ex-exchange basis.

以下收入評論將以交易所為基礎。

Our Human Health business sustained its momentum with sales increasing 8%, driven primarily by oncology.

我們的人類健康業務保持強勁勢頭，銷售額成長 8%，主要受到腫瘤學的推動。

Our Animal Health business also delivered strong performance, with sales growth of 13%.

我們的動物保健業務也表現強勁，銷售額成長了 13%。

Turning to the performance of our key brands.

談談我們主要品牌的表現。

In oncology, sales of KEYTRUDA grew 21% to $7.8 billion, driven by continued robust global demand from metastatic indications and increased uptake from earlier-stage cancers.

在腫瘤學領域，KEYTRUDA 的銷售額成長了 21%，達到 78 億美元，這得益於全球轉移性癌症需求持續強勁以及早期癌症治療的增加。

In the US, KEYTRUDA grew across all key tumor types.

在美國，KEYTRUDA 在所有主要腫瘤類型中均有成長。

In metastatic disease, we saw increased uptake for KEYTRUDA in combination with Padcev in first-line, locally advanced urothelial cancer, supported by the strong results from KEYNOTE-A39; as well as KEYTRUDA in combination with chemotherapy in first-line endometrial cancer, based on the compelling data from KEYNOTE-868.

在轉移性疾病中，我們看到 KEYTRUDA 與 Padcev 聯合用於一線局部晚期尿路上皮癌的治療的吸收率增加，這得到了 KEYNOTE-A39 的強勁結果的支持；以及基於 KEYNOTE-868 的令人信服的數據，KEYTRUDA 聯合化療用於一線子宮內膜癌治療。

In the earlier-stage setting, growth was driven by increased use in resectable non-small cell lung cancer as well as triple negative breast cancer.

在早期階段，可切除的非小細胞肺癌以及三陰性乳癌的使用增加推動了成長。

Outside the US, growth was driven by increased uptake in earlier stage cancers, including high-risk, early-stage triple negative breast cancer, as well as continued demand in metastatic disease.

在美國以外，成長的動力來自於早期癌症（包括高風險、早期三陰性乳癌）的治療需求增加，以及轉移性疾病的持續需求。

Inflation-related price increases consistent with market practice in Argentina also contributed to growth.

與阿根廷市場慣例相符的通貨膨脹相關價格上漲也促進了成長。

Our broader oncology portfolio achieved strong growth including WELIREG, with sales more than doubling to $160 million driven by increased uptake in certain patients with previously treated advanced renal cell carcinoma in the US.

我們更廣泛的腫瘤學產品組合實現了強勁增長，其中包括 WELIREG，其銷售額增長了一倍多，達到 1.6 億美元，這得益於美國某些先前接受過治療的晚期腎細胞癌患者的吸收增加。

In Vaccines, GARDASIL sales were $1.6 billion, a decrease of 18% due to lower demand in China.

在疫苗方面，GARDASIL 的銷售額為 16 億美元，由於中國需求下降而下降了 18%。

In the US, sales benefitted from price and demand, partially offset by CDC purchasing patterns.

在美國，銷售受益於價格和需求，但被 CDC 的採購模式部分抵銷。

Outside the US and China, double-digit sales growth was driven by higher overall demand, including the catch-up cohort in Japan.

在美國和中國以外，兩位數的銷售成長是由整體需求的增加所推動的，其中包括日本的追趕者。

In pneumococcal, CAPVAXIVE sales were $50 million, driven by demand from the retail pharmacy channel.

在肺炎球菌領域，CAPVAXIVE 的銷售額為 5,000 萬美元，這得益於零售藥局通路的需求。

We have made great progress in achieving the commercial milestones necessary to ensure a successful launch and are well positioned to help protect adults from invasive pneumococcal disease.

我們在實現確保成功發布所需的商業里程碑方面取得了巨大進展，並且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 sales decreased 9% as growth from launches in international markets was more than offset by competitive pressures in the US.

VAXNEUVANCE 的銷售額下降了 9%，因為國際市場的成長被美國的競爭壓力所抵消。

In Cardiovascular, we are seeing steady growth from the ongoing launch of WINREVAIR, which contributed $200 million of sales, predominantly in the US, where we saw some impact to prescription volumes due to the holiday season.

在心血管領域，我們看到 WINREVAIR 的持續推出帶來了穩定成長，該產品貢獻了 2 億美元的銷售額，主要集中在美國，假期季節對處方量產生了一定影響。

Approximately 1,500 new patients in the US received a prescription, bringing the total number of new patients prescribed to approximately 5,200 since launch.

美國約有 1,500 名新患者獲得了處方，自推出以來，新患者處方總數已達到約 5,200 名。

Access remains strong, and our experience continues to indicate that approximately 80% of those patients who receive a prescription will receive commercial product.

藥物取得管道依然暢通，我們的經驗表明，大約 80% 的處方患者將獲得商業產品。

Notably, we continue to see the vast majority of patients remain on treatment.

值得注意的是，我們繼續看到絕大多數患者繼續接受治療。

The breadth of physicians and depth at which they prescribe continues to grow.

醫師的診療範圍和深度不斷擴大。

We are also seeing an increase in the percentage of prescriptions for patients not on prostacyclin background therapy.

我們也發現未接受前列環素背景治療的患者處方藥比例增加。

Outside the US, initial launches are progressing well.

在美國以外，初期發布工作進展順利。

In summary, we remain confident in our growth expectations for WINREVAIR as we look forward to positively impacting more patients with pulmonary arterial hypertension.

總之，我們對 WINREVAIR 的成長預期仍然充滿信心，我們期待對更多肺動脈高壓患者產生正面影響。

Our Animal Health business delivered another quarter of strong growth, with sales increasing 13%.

我們的動物保健業務又實現了一個季度的強勁成長，銷售額成長了 13%。

Livestock growth reflects higher demand for poultry, sales from the recently acquired aqua portfolio from Elanco, and price.

畜牧業的成長反映了對家禽的需求增加、最近從 Elanco 收購的水產產品組合的銷售額以及價格。

Companion animal sales growth reflects price.

伴侶動物銷售成長反映價格。

I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis.

現在我將向您介紹我們損益表的剩餘部分，我的評論將基於非 GAAP 基礎。

Gross margin was 80.8%, an increase of 3.6 percentage points driven by reduced royalty rates for KEYTRUDA and GARDASIL, as well as favorable product mix.

毛利率為 80.8%，成長 3.6 個百分點，主要由於 KEYTRUDA 和 GARDASIL 專利費率降低以及產品組合有利。

Operating expenses decreased to $7.4 billion.

營業費用減少至74億美元。

Charges of $700 million related to the license agreements with LaNova and Hansoh Pharma this quarter were lower than the charge of $5.5 billion a year ago related to the collaboration with Daiichi Sankyo.

本季與 LaNova 和 Hansoh Pharma 達成的授權協議相關的費用為 7 億美元，低於去年同期與第一三共合作相關的 55 億美元費用。

Excluding these charges, operating expenses grew 10%, reflecting strategic investments in support of our robust early- and late-phase pipeline and key growth drivers.

除這些費用外，營業費用成長了 10%，反映了對支持我們強勁的早期和後期產品線以及關鍵成長動力的策略性投資。

Other expense was $5 million.

其他費用為500萬美元。

Our tax rate was 16.2%.

我們的稅率是16.2%。

Taken together, earnings per share were $1.72.

整體來看，每股收益為 1.72 美元。

Now turning to our 2025 non-GAAP guidance.

現在來談談我們的 2025 年非 GAAP 指引。

We expect revenue to be between $64.1 and $65.6 billion, representing growth of 2% to 4%, excluding a negative impact from foreign exchange of approximately 2% using mid-January rates.

我們預計營收在 641 億美元至 656 億美元之間，成長 2% 至 4%，不包括以 1 月中旬匯率計算的約 2% 的外匯負面影響。

For GARDASIL in China, our guidance assumes no further shipments at the low-end and less than $1 billion at the high-end.

對於中國的 GARDASIL，我們的指導假設是低端產品不會進一步出貨，高端產品出貨量將少於 10 億美元。

Excluding sales of GARDASIL in China in both 2024 and 2025 and the negative impact from foreign exchange, total company growth is expected to be 7% to 9%.

除去 2024 年和 2025 年 GARDASIL 在中國的銷售額以及外匯帶來的負面影響，預計公司整體成長率為 7% 至 9%。

Our gross margin assumption is approximately 82.5%.

我們的毛利率假設約為82.5%。

Operating expenses are assumed to be between $25.4 billion and $26.4 billion.

預計營運費用在 254 億美元至 264 億美元之間。

This range includes a $300 million payment related to the license agreement with LaNova which will be recognized upon completion of the technology transfer for MK-2010.

該範圍包括與 LaNova 達成的許可協議相關的 3 億美元付款，該款項將在 MK-2010 的技術轉移完成後確認。

As a reminder, our guidance does not assume additional significant potential business development transactions.

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。

Other expense is expected to be between $300 million and $400 million.

其他支出預計在3億至4億美元之間。

We assume a full-year tax rate between 16.0% and 17.0%.

我們假設全年稅率在 16.0% 至 17.0% 之間。

We assume approximately 2.53 billion shares outstanding.

我們估計流通股數約為 25.3 億股。

Taken together, we expect EPS of $8.88 to $9.03. This range includes approximately $0.09 related to the expected payment to LaNova and a negative impact from foreign exchange of approximately $0.35 using mid-January rates.

綜合來看，我們預計每股收益為 8.88 美元至 9.03 美元。該範圍包括與預期支付給 LaNova 的金額相關的約 0.09 美元，以及以 1 月中旬匯率計算的約 0.35 美元的外匯負面影響。

As you consider your models, there are a few items to keep in mind.

當你考慮你的模型時，有幾點需要牢記。

In 2025, we are expecting to see the benefit of a more diverse commercial portfolio with continued strength in oncology and Animal Health, as well as contributions from new product launches.

到 2025 年，我們預計將看到更多樣化的商業組合帶來的好處，其中包括腫瘤學和動物保健領域的持續強勁發展以及新產品發布的貢獻。

During the first half of the year, we expect roughly flat year-over-year revenues as the headwind in China is offset by high single-digit growth across the rest of our business.

我們預計上半年營收將與去年同期基本持平，因為中國市場的不利因素被其他業務的高個位數成長所抵銷。

During the second half, we expect strong year-over-year growth.

我們預計下半年將實現強勁的年成長。

Looking at GARDASIL longer-term, while we believe there continues to be a path to the $11 billion, we feel it is prudent to withdraw this target given the uncertain timing of an economic recovery in China.

從 GARDASIL 的長期來看，雖然我們相信該藥物仍有望達到 110 億美元，但考慮到中國經濟復甦時機的不確定性，我們認為撤回這一目標是明智之舉。

Our growth expectations outside of China for this important vaccine remain unchanged, and we are well-positioned to protect more lives and drive strong growth beyond 2025.

我們對這項重要疫苗在中國以外的成長預期保持不變，我們已做好準備，保護更多生命，並在 2025 年後實現強勁增長。

For KEYTRUDA, US sales benefitted from approximately $200 million of wholesaler inventory buy-in during the fourth quarter, which we expect to reverse in the first quarter.

對於 KEYTRUDA 而言，美國銷售受益於第四季度約 2 億美元的批發商庫存買入，我們預計第一季這一趨勢將逆轉。

We expect Medicare Part D redesign to have a negative impact to sales of approximately $400 million, primarily affecting WINREVAIR and our portfolio of small molecule oncology products, including WELIREG, Lynparza, and Lenvima.

我們預計 Medicare Part D 的重新設計將對銷售額產生約 4 億美元的負面影響，主要影響 WINREVAIR 和我們的小分子腫瘤產品組合，包括 WELIREG、Lynparza 和 Lenvima。

At the beginning of 2025, we lowered the list prices of the JANUVIA family of products in the US to more closely align them with net prices.

2025 年初，我們降低了美國 JANUVIA 系列產品的標價，以使其與淨價更加接近。

The lower list price will reduce the rebate amount Merck pays to Medicaid.

較低的標價將會減少默克公司向醫療補助計劃支付的回扣金額。

And as a result, we expect higher net sales for these products in 2025.

因此，我們預計 2025 年這些產品的淨銷售額將會更高。

Now turning to capital allocation, where our strategy remains unchanged.

現在轉向資本配置，我們的策略保持不變。

We will prioritize investments in our business to drive near- and long-term growth.

我們將優先投資我們的業務，以推動近期和長期成長。

We will continue to make disciplined investments in our key growth drivers and expansive pipeline.

我們將繼續對我們的關鍵成長動力和擴展產品線進行嚴格的投資。

We remain committed to our dividend, with the goal of continuing to increase it over time.

我們將繼續致力於提高股息，並目標是隨著時間的推移繼續增加股息。

Business development remains a priority, and we are well positioned to pursue additional science-driven, value-enhancing transactions.

業務發展仍然是我們的首要任務，我們已做好準備，尋求更多以科學為導向、可提升價值的交易。

We recently increased our authorization for share repurchases by $10 billion to $12 billion in total.

我們最近將股票回購授權金額增加了 100 億美元，總計達到 120 億美元。

Given the opportunities to invest in our business and augment our pipeline through business development, we expect to maintain a modest level of share repurchases this year.

考慮到我們有機會投資我們的業務並透過業務發展擴充我們的產品線，我們預計今年將保持適度的股票回購水準。

We remain committed to not having excess cash build on our balance sheet, and the higher authorization provides flexibility to increase share repurchases, if appropriate.

我們仍然致力於不在資產負債表上累積過多的現金，而更高的授權提供了增加股票回購的靈活性（如果合適）。

To conclude, we enter 2025 with confidence in the outlook for our business, driven by global demand for our innovative medicines and vaccines, as well as our exceptional pipeline.

總而言之，在全球對我們的創新藥物和疫苗的需求以及我們卓越的產品線的推動下，我們對我們的業務前景充滿信心地邁入 2025 年。

Our long-standing commitment to leverage leading-edge science to improve the lives of patients has put us in a position of financial and operational strength.

我們長期致力於利用尖端科學來改善患者的生活，這使我們擁有財務和營運實力。

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。

Thank you, Caroline.

謝謝你，卡洛琳。

Good morning.

早安.

We are making progress in early- and late-phase programs across multiple therapeutic areas.

我們在多個治療領域的早期和後期項目上取得了進展。

Today, I will cover major updates since the last earnings call and provide a summary of highlights from 2024, starting with cardiometabolic disease.

今天，我將介紹自上次財報電話會議以來的主要更新，並從心臟代謝疾病開始，總結 2024 年的亮點。

The Phase 3 ZENITH trial evaluating WINREVAIR in patients with pulmonary arterial hypertension who are at high risk demonstrated a statistically significant reduction in the risk of morbidity or mortality events compared to placebo, both on top of background PAH therapy.

階段 3 ZENITH 試驗對高風險肺動脈高壓患者進行了評估，結果表明，與安慰劑相比，WINREVAIR 可顯著降低發病率或死亡事件風險，且均在背景 PAH 治療的基礎上進行。

Based on the overwhelming efficacy, the trial was stopped so that all participants have the option to receive WINREVAIR.

由於其壓倒性的療效，試驗被停止，以便所有參與者都可以選擇接受 WINREVAIR。

Detailed results will be presented at the American College of Cardiology’s ACC.25 conference in late March.

詳細結果將於三月下旬在美國心臟學會 ACC.25 會議上公佈。

Following a review of the totality of efficacy data from the WINREVAIR clinical program, including positive results from the ZENITH trial, the External Steering Committee and Merck unanimously concluded that the Phase 3 HYPERION study should stop early.

在審查了 WINREVAIR 臨床計畫的全部療效數據（包括 ZENITH 試驗的正面結果）後，外部指導委員會和默克公司一致得出結論，認為第 3 階段 HYPERION 研究應提前停止。

We discussed this with the FDA and have notified study investigators.

我們與 FDA 討論了此事並通知了研究人員。

Based on the strong clinical benefit WINREVAIR demonstrated in the STELLAR and ZENITH trials, it was determined that the HYPERION study had lost clinical equipoise.

根據 WINREVAIR 在 STELLAR 和 ZENITH 試驗中所表現出的強大臨床益處，確定 HYPERION 研究已經失去臨床平衡。

The study will remain blinded, and all participants will have the option to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA.

研究將保持盲法，所有參與者都可以選擇接受 WINREVAIR 作為開放標籤、長期擴展研究 SOTERIA 的一部分。

We anticipate data will be available later this year, and we will present at a future medical congress.

我們預計數據將在今年稍後公佈，並將在未來的醫學會議上展示。

This reinforces growing recognition that WINREVAIR, the first and only activin-signaling inhibitor for the treatment of PAH, has the potential to change the practice of medicine and be transformational for patients with this progressive and debilitating disease.

這進一步證實了人們日益增長的認識，即 WINREVAIR 作為第一個也是唯一一個用於治療 PAH 的活化訊號抑制劑，有可能改變醫療實踐，並為患有這種進行性和衰弱性疾病的患者帶來變革性的影響。

WINREVAIR has now been approved in more than 35 countries globally.

WINREVAIR 目前已在全球 35 多個國家獲得批准。

Recently, we submitted an application for approval to regulatory authorities in Japan.

最近，我們向日本監管機構提交了批准申請。

More broadly in the cardiometabolic space, in December, we entered a licensing agreement with Hansoh Pharma for an investigational preclinical oral small molecule GLP-1 receptor agonist, now known as MK-4082, which will be entering the clinic this year.

更廣泛地講，在心臟代謝領域，12 月，我們與 Hansoh Pharma 達成了一項許可協議，針對一項臨床前口服小分子 GLP-1 受體激動劑（現稱為 MK-4082）進行研究，該藥物將於今年進入臨床階段。

With our extensive experience in incretin biology, we are well-positioned to advance oral small molecule GLP-1 agonist-containing combinations with next generation agents for weight loss, as well as those that target cardiometabolic disease.

憑藉我們在腸促胰島素生物學方面的豐富經驗，我們有能力推進含口服小分子 GLP-1 激動劑的組合與下一代減肥藥物以及針對心臟代謝疾病的藥物。

Next, infectious diseases.

接下來是傳染病。

The FDA has set a target action date of June 10 for clesrovimab, our prophylactic, long-acting monoclonal antibody for infants entering their first RSV season, when the risk of serious illness is greatest.

FDA 已將 clesrovimab 的目標行動日期設定為 6 月 10 日，clesrovimab 是我們針對進入第一個 RSV 季節的嬰兒的預防性長效單株抗體，此時患有嚴重疾病的風險最高。

If approved, clesrovimab would be the first and only single-dose passive immunization for infants irrespective of weight with the potential to protect babies for the full RSV season.

如果獲得批准，clesrovimab 將成為第一個也是唯一一個針對嬰兒的單劑量被動免疫藥物，無論體重如何，能夠在整個 RSV 季節為嬰兒提供保護。

Turning to HIV.

轉向愛滋病毒。

We announced top-line results from the two pivotal Phase 3 trials evaluating the investigational, once-daily, oral combination of doravirine and islatravir in adults with HIV infection that is virologically suppressed on different antiretroviral therapy regimens.

我們發表了兩項關鍵性 3 期試驗的首要結果，這兩項試驗評估了多拉韋林和伊拉曲韋的每日一次口服組合療法對透過不同的抗逆轉錄病毒療法獲得病毒學抑制的 HIV 感染成人患者的療效。

Detailed findings from these studies will be presented at an upcoming scientific congress, and we plan to submit the data as part of a package for regulatory approval.

這些研究的詳細結果將在即將召開的科學大會上公佈，我們計劃將這些數據作為一攬子計劃的一部分提交給監管部門批准。

Islatravir, a potentially first-in-class nucleoside reverse transcriptase translocation inhibitor, is also being evaluated in multiple late-phase clinical trials in combination with other antiretroviral therapies for the treatment of HIV.

Islatravir 是一種潛在的同類首創核苷逆轉錄酶易位抑制劑，也正在多個後期臨床試驗中與其他抗逆轉錄病毒療法聯合用於治療愛滋病毒。

This includes ongoing Phase 3 trials in combination with Gilead’s capsid inhibitor, lenacapavir, as a once-weekly oral treatment option.

這包括正在進行的與吉利德衣殼抑制劑來那帕韋聯合使用的 3 期試驗，作為每週一次的口服治療選擇。

We are also evaluating MK-8527, another investigational NRTTI candidate, as a potentially important once-monthly oral option for pre-exposure prophylaxis which we expect to advance to Phase 3 this year.

我們也正在評估另一種研究性 NRTTI 候選藥物 MK-8527，將其作為一種潛在重要的每月一次口服暴露前預防藥物，我們預計今年將進入第 3 階段。

Next, to vaccines.

接下來是疫苗。

The National Medical Products Administration of China approved GARDASIL to help prevent certain HPV-related cancers and diseases in males 9 to 26 years old.

中國國家藥品監督管理局批准GARDASIL用於幫助9至26歲男性預防某些HPV相關的癌症和疾病。

In November, at the International Papillomavirus Conference, we presented new clinical and real-world data for GARDASIL 9 that examined the prevalence of oral HPV infection, the burden of HPV-related head and neck cancers, as well as rates of HPV infection in females.

11 月，在國際乳突病毒會議上，我們展示了 GARDASIL 9 的新臨床和真實世界數據，該數據研究了口腔 HPV 感染的盛行率、HPV 相關頭頸癌的負擔以及女性 HPV 感染率。

This evidence reinforces the importance of gender-neutral HPV vaccination with GARDASIL in adults up to age 45.

這項證據強調了 45 歲以下成年人接種 GARDASIL 性別中性 HPV 疫苗的重要性。

More recently, the American Cancer Society’s annual report on cancer facts and trends noted an increase in cervical cancer diagnosis rates in females ages 30 to 44.

最近，美國癌症協會關於癌症事實和趨勢的年度報告指出，30 至 44 歲女性的子宮頸癌診斷率上升。

There remains a need to protect more individuals from HPV-related cancers.

仍需要保護更多的人免受 HPV 相關癌症的侵害。

In Europe, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of CAPVAXIVE for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults.

在歐洲，歐洲藥品管理局人用藥品委員會建議批准CAPVAXIVE用於主動免疫，預防成人侵襲性疾病和肺炎鏈球菌引起的肺炎。

Moving to oncology.

轉向腫瘤學。

Our Phase 3 trial evaluating the investigational subcutaneous fixed-dose combination of pembrolizumab and berahyaluronidase alfa, in combination with chemotherapy, compared to intravenous KEYTRUDA with chemotherapy met its dual primary pharmacokinetic parameter endpoints of noninferiority.

我們的 3 期試驗評估了皮下固定劑量 pembrolizumab 和 berahyaluronidase alfa 組合與化療的聯合治療，並與靜脈注射 KEYTRUDA 與化療進行了比較，結果達到了非劣效性的雙重主要藥物動力學參數終點。

If approved, this route of administration would be a meaningful option for patients.

如果獲得批准，這種給藥途徑將對患者來說是一個有意義的選擇。

We plan to share detailed findings of the study at an upcoming scientific congress.

我們計劃在即將召開的科學大會上分享該研究的詳細結果。

Consistent with our growing, and increasingly diverse, pipeline of oncology candidates, more than 20 abstracts from studies evaluating treatment options for a range of hematologic malignancies were presented at the American Society of Hematology Annual Meeting.

與我們不斷成長且日益多樣化的腫瘤候選藥物管道一致，在美國血液學會年會上展示了 20 多篇評估一系列血液系統惡性腫瘤治療方案的研究摘要。

This included early results from the Phase 2 waveLINE-007 study evaluating zilovertamab vedotin, an investigational antibody drug conjugate targeting ROR1, in patients with diffuse large B-cell lymphoma.

其中包括第 2 階段 waveLINE-007 研究的早期結果，該研究評估了 zilovertamab vedotin（一種針對 ROR1 的試驗性抗體藥物偶聯物）在瀰漫性大 B 細胞淋巴瘤患者中的療效。

On the regulatory front, in China, we received three approvals for KEYTRUDA-based regimens including a neoadjuvant/adjuvant treatment regimen for patients with resectable non-small cell lung cancer based on KEYNOTE-671, the treatment of certain types of locally advanced cervical cancer based on KEYNOTE-A18, and first-line treatment of patients with urothelial carcinoma in combination with Padcev based on KEYNOTEA39.

監管方面，在中國，我們獲得三項基於KEYTRUDA的方案的批准，包括基於KEYNOTE-671的針對可切除非小細胞肺癌患者的新輔助/輔助治療方案、基於KEYNOTE-A18的針對某些類型局部晚期子宮頸癌的治療方案、以及基於KEYNOTEA39的與Padcev聯合用於尿路癌患者的一線治療。

In addition, WELIREG was approved for the treatment of adult patients with VHL-associated renal cell carcinoma based on LITESPARK-004.

此外，WELIREG也基於LITESPARK-004獲準用於治療VHL相關腎細胞癌成年患者。

In Japan, The Ministry of Health, Labour, and Welfare approved two KEYTRUDA-based regimens including the treatment of advanced cervical cancer based on KEYNOTE-A18 and for primary advanced or recurrent endometrial carcinoma based on KEYNOTE-868.

在日本，厚生勞動省批准了兩種基於 KEYTRUDA 的方案，包括基於 KEYNOTE-A18 的晚期子宮頸癌治療方案和基於 KEYNOTE-868 的原發性晚期或複發性子宮內膜癌治療方案。

In the US, the FDA granted breakthrough therapy designation to sac-TMT, our investigational TROP-2-directed antibody drug conjugate for the treatment of certain patients with previously treated advanced non-small cell lung cancer.

在美國，FDA 授予 sac-TMT 突破性治療藥物資格，sac-TMT 是我們正在研究的針對 TROP-2 的抗體藥物偶聯物，用於治療某些先前接受過治療的晚期非小細胞肺癌患者。

Sac-TMT is being developed through a collaboration with Kelun-Biotech with 10 ongoing Phase 3 studies across multiple solid tumors.

Sac-TMT 是由該公司與科倫博泰合作開發的，目前正針對多種實體腫瘤進行 10 項 3 期研究。

Finally, in December, we completed an exclusive global license agreement with LaNova Medicines for a novel investigational PD-1/VEGF bispecific antibody now known as MK-2010.

最後，在 12 月，我們與 LaNova Medicines 達成了一項針對新型研究 PD-1/VEGF 雙特異性抗體（現稱為 MK-2010）的全球獨家授權協議。

We plan to explore the full potential of MK-2010 across multiple tumor types in a global patient population.

我們計劃在全球患者群體中探索 MK-2010 對多種腫瘤類型的全部潛力。

As Rob mentioned, 2024 was marked by significant pipeline progress.

正如 Rob 所提到的，2024 年標誌著管道取得重大進展。

Greater than 20 Phase 3 studies were initiated, spanning cardiometabolic, immunology, infectious diseases, oncology, ophthalmology, and vaccines.

已啟動 20 多項 3 期研究，涵蓋心臟代謝、免疫學、傳染病、腫瘤學、眼科和疫苗領域。

We received more than 25 regulatory approvals in major regions, including for WINREVAIR and CAPVAXIVE.

我們在主要地區獲得了超過 25 項監管部門的批准，其中包括 WINREVAIR 和 CAPVAXIVE。

At the same time, we successfully executed on our one pipeline strategy by leveraging our clinical expertise and business development capabilities to identify and secure external opportunities where science, medical need, and value intersected to expand, complement, and diversify the pipeline.

同時，我們利用臨床專業知識和業務開發能力，識別並獲得科學、醫療需求和價值相交的外部機會，從而擴大、補充和多樣化產品線，成功執行了我們的單一產品線策略。

Acquisitions of Harpoon and EyeBio, as well as an asset from Curon, added important new biologic candidates in oncology, ophthalmology, and immunology, respectively.

收購 Harpoon 和 EyeBio 以及從 Curon 獲得資產，分別增加了腫瘤學、眼科學和免疫學領域重要的新生物候選藥物。

License agreements with Hansoh and LaNova secured rights to potentially important candidates for cardiometabolic disease and oncology.

與 Hansoh 和 LaNova 簽訂的授權協議確保了心臟代謝疾病和腫瘤學領域潛在重要候選藥物的權利。

Notable milestones to look out for in 2025 include detailed results from the ZENITH trial, from islatravir-based regimens in HIV and in oncology for subcutaneous pembrolizumab, as well as KEYTRUDA in earlier-stage head and neck squamous cell carcinoma are all scheduled to be presented at upcoming medical meetings.

2025 年值得關注的里程碑包括 ZENITH 試驗的詳細結果、以 islatravir 為基礎的 HIV 治療方案和皮下注射派姆單抗的腫瘤治療方案以及 KEYTRUDA 在早期頭頸部鱗狀細胞癌治療中的詳細結果，這些都將在即將召開的醫學會議上公佈。

Results from three Phase 3 registration-enabling studies evaluating our oral PCSK9 inhibitor candidate enlicitide for the treatment of hypercholesterolemia are anticipated.

我們預計將公佈三項 3 期註冊研究的結果，評估我們的口服 PCSK9 抑制劑候選藥物恩利肽用於治療高膽固醇血症的效果。

And the primary completion date of the Phase 2 CADENCE study evaluating WINREVAIR in pulmonary hypertension due to left heart disease is scheduled for the Fall.

而用於評估 WINREVAIR 在治療左心疾病所致肺動脈高壓方面的療效的第 2 階段 CADENCE 研究的初步完成日期定於秋季。

I look forward to providing further updates on our pipeline progress.

我期待提供有關我們管道進展的進一步更新。

And now, I will turn the call back to Peter.

現在，我將把電話轉回給彼得。

Thank you, Dean.

謝謝你，迪恩。

Shirley, we're now ready for questions.

雪莉，現在我們可以回答問題了。

I'd request that analysts limit themselves to one question to get to many questioners as possible.

我要求分析師只問一個問題，以便盡可能回答提問者的問題。

Thank you.

謝謝。

Thank you.

謝謝。

(Operator Instructions) Umer Raffat, Evercore ISI.

（操作員指示）Umer Raffat，Evercore ISI。

I realize that there's a lot of folks on GARDASIL this morning, but allow me to focus on another growth driver, which tracked slightly weaker versus consensus, WINREVAIR.

我知道今天早上有很多人在談論 GARDASIL，但請允許我重點討論另一個增長動力，其走勢略弱於普遍預期，即 WINREVAIR。

And my question really is, as we think about the cadence of growth into '25, there's been some question marks off of some claims data suggesting maybe the start of the year might have been slightly weaker versus some of the growth expectations.

我的問題是，當我們思考25年的成長節奏時，一些失業救濟申請數據存在一些問號，顯示今年年初的數據可能略弱於一些成長預期。

So do you feel reasonably comfortable that WINREVAIR can grow about 100% year over year from the fourth-quarter trends into end of '25?

那麼，您是否有理由相信 WINREVAIR 能夠從第四季度的趨勢到 25 年底實現年增約 100%？

Yeah.

是的。

Umer, thanks for the question.

烏梅爾，謝謝你的提問。

And this is Rob.

這是羅布。

I would just say, overall, our confidence in WINREVAIR and the potential benefit for patients with PAH and, in turn, its importance for growth are unchanged.

我只想說，總的來說，我們對 WINREVAIR 的信心以及它對 PAH 患者的潛在益處以及它對成長的重要性沒有改變。

And as we look at what's happening in January, actually, we're seeing January returning to the levels we would have expected it to be.

當我們回顧一月份發生的情況時，實際上，我們看到一月份已經回到了我們預期的水平。

And so as we look at 2025, we do actually see this as a strong growth contributor, and all of the fundamentals we see support that.

因此，展望 2025 年，我們確實將其視為強勁的成長貢獻者，而且我們看到的所有基本面都支持這一點。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林 (Terence Flynn)。

I was just wondering if the change in outer-year GARDASIL sales impacts at all how you're thinking about either the size, the type, or the cadence of your M&A and business development strategy here.

我只是想知道，外年 GARDASIL 銷售的變化是否會對您對規模、類型或併購和業務發展策略的節奏產生影響。

Does this open the door to maybe larger deals now?

這是否會為更大規模的交易打開大門？

Yeah.

是的。

No, thanks for the question.

不，謝謝你的提問。

As we look forward, and I think as we've been pretty consistent, the long-term expectations we had at the company, especially as we get into the LOE period, were never counting on GARDASIL as a growth driver.

展望未來，我認為我們一直非常堅持不懈，我們對公司的長期期望，特別是當我們進入 LOE 時期時，從未指望 GARDASIL 作為成長動力。

Because we always had an expectation that eventually, it would start to plateau as we got through all of the cohorts.

因為我們始終期望，隨著我們完成所有隊列，它最終會開始穩定下來。

And really, we're back to just the birth cohort.

事實上，我們又回到了出生隊列。

So as we look forward, our expectation for what the post-LOE period looks like is frankly unchanged from what I previously communicated.

因此，展望未來，我們對 LOE 後時期的預期與我之前所傳達的相比，坦白說沒有改變。

That said, as we've also communicated, while I feel increasingly confident about that period, we have always said we do believe we need to do more to continue to augment the pipeline we've built.

儘管如此，正如我們所溝通的那樣，雖然我對那段時期越來越有信心，但我們始終表示，我們確實相信我們需要做更多工作來繼續擴充我們已經建立的管道。

And so we will continue to do -- to drive business development and we're looking at business development in a full range, always with science being the leading question.

因此，我們將繼續推動業務發展，並全方位審視業務發展，並始終以科學為主導問題。

But if we can see value and a tie in to our strategy where science intersects, we will be willing to move.

但如果我們能夠看到價值並且看到科學與我們的策略交叉的地方，我們就會願意採取行動。

And it will still be in that -- $0 to $15 billion range is our sweet spot, but obviously, open to looking at deals.

而且它仍然會處於這個範圍內——0 到 150 億美元是我們的最佳範圍，但顯然，我們也願意考慮交易。

And as we've also said, we're open to commercialized assets as well, if they fit the overall profile I laid out of science and value.

而且正如我們所說的，如果商業化資產符合我所概述的科學和價值的整體概況，我們也對它們持開放態度。

Luisa Hector, Berenberg.

路易莎·赫克托（Luisa Hector），貝倫貝格。

Perhaps on the oral PCSK9, could you just add a bit more color around what you're targeting for cholesterol lowering, whether we might need to see all three trials in-house before you issue a press release?

也許關於口服 PCSK9，您能否更詳細地介紹您降低膽固醇的目標，在發布新聞稿之前我們是否需要內部審查這三項試驗？

And I think you mentioned before potential combinations.

我覺得您之前提到過潛在的組合。

Obviously, you have now optionality on the oral GLP.

顯然，您現在可以選擇口服 GLP。

So just perhaps some color around where you could go with further development.

因此，也許只是一些關於您可以進行進一步開發的地方的細節。

I'll take that.

我接受。

Thank you very much for the question.

非常感謝您的提問。

This is Dean.

這是迪恩。

Yeah, we have three Phase 3s that are ongoing that should be reading out April, July, and August of 2025.

是的，我們有三個正在進行的第三階段，應該分別在 2025 年 4 月、7 月和 8 月完成。

I would imagine that there is a possibility that, given a prominent conference at the end of the year, that we would hope to be able to present publicly that data.

我可以想像，如果在年底召開一次重要會議，我們有可能希望能夠公開這些數據。

In relationship to what we're trying to achieve with oral PCSK9, I would just look at what the antibodies can do and just say, we want to achieve a very similar profile of the PCSK9 antibodies in an oral molecule because we believe that there is a great unmet need.

關於我們試圖透過口服 PCSK9 實現的目標，我只想研究抗體的作用，然後說，我們希望在口服分子中實現與 PCSK9 抗體非常相似的特性，因為我們相信存在很大的未滿足需求。

70% of people on statins are not at goal.

70%服用他汀類藥物的人沒有達到目標。

So we think that this will be an important set of data.

所以我們認為這將是一組重要的數據。

And if it reads out positive, we're eager to get this out to the general population just in the United States, but throughout the globe.

如果結果是正面的，我們就會急切地將這消息告知美國乃至全世界的廣大民眾。

In terms of combinations, there are a number of combinations that one could do.

就組合而言，可以進行多種組合。

And I like how you put it because it ends up being something that's really important as a singular drug, but it also is a platform to add other important cardiometabolic assets onto it or compounds that could give even greater cardiovascular outcomes.

我喜歡你的說法，因為它最終成為一種非常重要的單一藥物，但它也是一個平台，可以添加其他重要的心臟代謝資產或可以產生更大心血管結果的化合物。

And so we will probably be providing that data a little bit later after we've cleared the Phase 3s for the oral PCSK9 inhibitor, enlicitide.

因此，我們可能會在口服 PCSK9 抑制劑 enlicitide 的 3 期臨床試驗結束後稍後提供該數據。

Mohit Bansal, Wells Fargo.

富國銀行的莫希特·班薩爾 (Mohit Bansal)。

Sorry, I joined a little bit late.

抱歉，我加入得有點晚了。

But if the question -- have you commented on how much inventory Zhifei had at this point with GARDASIL?

但如果問題是——您是否評論過目前志飛擁有多少 GARDASIL 庫存？

And would the decision to stop shipment, possible shipments for first half, would take care of the inventory?

並且，停止出貨（可能停止上半年的出貨）的決定是否會解決庫存問題？

I'm just trying to get -- understand the demand situation in China, sir.

先生，我只是想了解中國的需求狀況。

Yeah.

是的。

Mohit, thanks for the question.

Mohit，謝謝你的提問。

We have not commented specifically on how much inventory Zhifei is sitting on.

我們尚未具體評論志飛持有多少庫存。

They're a public company, so we need to leave it to them to make comments about that.

他們是一家上市公司，所以我們需要讓他們對此發表評論。

But I think the important point here is to understand that as we've seen the marketplace, what we intend to is to accelerate that drawdown.

但我認為這裡的重點是要明白，正如我們所看到的市場，我們想要的是加速這種下降。

So we are planning to ship and by -- frankly, by not shipping February potentially through the midyear and essentially longer, depending on how we see the inventory come down, we're going to allow the underlying demand that is still there to absorb the Zhifei inventory and improve Zhifei's financial position and working capital.

因此，我們計劃發貨——坦率地說，通過不發貨到二月份，可能一直到年中甚至更長的時間，這取決於我們看到的庫存下降情況，我們將允許仍然存在的潛在需求吸收智飛庫存並改善智飛的財務狀況和營運資金。

We think if we can put the inventory situation behind us, we can get to a more normal market dynamic, one where with the underlying demand and the fact you have the male indication coming, it can come back to growth.

我們認為，如果我們能夠擺脫庫存狀況，我們就可以進入一個更正常的市場動態，有了潛在的需求和男性症狀的出現，市場可以恢復成長。

So the speed with which we burn that down, we'll have to see.

所以，我們得看看燒毀它的速度有多快。

But the other thing I would just highlight for context, with this rebasing, GARDASIL China now is about 1% of our total earnings.

但我想強調的另一點是，經過這次調整，GARDASIL 中國現在約占我們總收入的 1%。

So it is becoming -- of our total revenue.

因此它正在成為我們的總收入。

So obviously, that's an important thing to understand.

顯然，理解這一點很重要。

And that's why we also highlighted that if you look at the way the business is going to progress, as we get into the back half of this year and we anniversary the GARDASIL China situation, we will be strong growth and -- for overall more -- as well as as we go into '26 and '27.

這就是為什麼我們也強調，如果你看看業務的發展方向，隨著我們進入今年下半年以及我們慶祝 GARDASIL 中國形勢週年，我們將實現強勁增長 - 總體而言 - 以及我們進入 26 年和 27 年。

And that's important because, obviously, at that point, anything that happens in China with GARDASIL is an upside.

這很重要，因為顯然，到那時，中國發生的任何有關 GARDASIL 的進展都是有利的。

And that's really why we've decided to now rebase this, understanding it's a change from the direction we had taken previously.

這就是我們決定現在重新制定基礎的原因，因為我們明白這與我們之前採取的方向不同。

Daina Graybosch, Leerink Partners.

Daina Graybosch，Leerink Partners。

I want to ask another one on WINREVAIR and the HYPERION trial.

我想再問一個 WINREVAIR 和 HYPERION 試驗的問題。

Can you help us understand what outcomes you may be able to provide from that trial given the enrollment and follow-up?

您能否幫助我們了解，考慮到受試者的入組和後續隨訪，您可以從該試驗中獲得什麼結果？

Is it possible to hit on the primary?

有可能擊中主要目標嗎？

Or any of the trends that you think would support use in these less severe patients, where I think physicians are more worried about the risk of the toxicity?

或者您認為有哪些趨勢支持在這些病情不太嚴重的患者中使用，而我認為醫生更擔心毒性風險？

Thanks for that question.

謝謝你的提問。

So if I could just take a step up and then address your HYPERION question directly.

因此，如果我可以更進一步，然後直接回答您的 HYPERION 問題。

So the aspiration of WINREVAIR was that it would be a first-in-class mechanism action of an activin-signaling inhibitor, and the molecular design was to address the fundamental human genetic basis.

因此，WINREVAIR 的目標是成為一流的活化訊號抑制劑機製作用，分子設計旨在解決人類的基本遺傳基礎。

And what we're trying to do is build the evidentiary wall of data that this novel mechanism can change the practice of medicine.

我們要做的就是建立數據證據牆，證明這種新機制可以改變醫療實踐。

So for STELLAR, that's already got an FDA and a global approval.

因此對於 STELLAR 而言，已經獲得了 FDA 和全球的批准。

And it's clear that it increases exercise capacity, increases functional class, and decreases risk of clinical worsening.

很明顯，它可以提高運動能力，提高功能等級，並降低臨床惡化的風險。

ZENITH is very important because it is, I believe, the first PAH trial ever to be done on hard outcomes.

ZENITH 非常重要，因為我相信這是有史以​​來第一次針對硬性結果進行的 PAH 試驗。

And I also believe it's the first PAH trial ever stopped early for overwhelming efficacy.

我還相信這是第一次因為療效太明顯而提前停止的 PAH 試驗。

I think in 2025 ACC, people are going to stare at that data and looked at lung transplantation, hospitalization, and death and look at that and also will also steer into how soon after treatment those benefits are observed.

我認為在 2025 年 ACC，人們將會關注這些數據，並關注肺移植、住院和死亡情況，同時也會關注治療後多久能夠觀察到這些益處。

So that leads me now to HYPERION, where HYPERION is actually in a very similar patient population as STELLAR.

因此我現在想到了 HYPERION，HYPERION 的患者群體實際上與 STELLAR 非常相似。

It's the earlier use of WINREVAIR in that patient population, and it was decided to stop early.

這是該患者群體中較早使用 WINREVAIR 的情況，並決定提前停止使用。

It remains blinded, but the investigators basically, having looked at all of the data, really felt that it was not as to go-to treatment.

它仍然是盲法的，但研究人員基本上在查看了所有數據後，確實認為它不是一種可行的治療方法。

So we will have to see what that data is because it remains blinded.

所以我們必須看清這些數據是什麼，因為它仍然是盲目的。

And hopefully, we will have that data and further updates.

希望我們能夠獲得這些數據和進一步的更新。

But again, the ZENITH updates will be in -- at ACC.

但再次強調，ZENITH 更新將在 ACC 中進行。

There is continuing safety data from the readout of these Phase 3s and consequent rollover patients into SOTERIA.

從這些第 3 階段的讀數以及隨後轉入 SOTERIA 的患者中可以獲得持續的安全數據。

And the long-term safety experience that we've had is very -- is well within the label.

而且，我們的長期安全經驗非常良好，完全符合標籤要求。

And I'll just remind everyone, the label says 4% in the treated and 1% in placebo, so it's maybe a 3%.

我只想提醒大家，標籤上寫著治療組 4%，安慰劑組 1%，所以可能是 3%。

We're well within those margins.

我們完全處於這些範圍內。

And so that data, as we get more and more information, will become more public this year as our investigators put together presentations and publications.

隨著我們獲得越來越多的信息，隨著我們的研究人員整理報告和出版物，這些數據將在今年變得更加公開。

So our aspiration of changing the practice of medicine for PAH has grown support.

因此，我們改變肺動脈高壓治療實踐的願望得到了越來越多的支持。

I know no other activin-signaling inhibitor in clinical development.

我不知道有其他促活素訊號抑制劑正在處於臨床開發中。

And also, we're clearly exploring outside of PAH, other forms of pulmonary hypertension.

而且，我們顯然正在探索 PAH 之外的其他形式的肺動脈高壓。

Geoff Meacham, Citi.

花旗銀行的 Geoff Meacham。

Sorry to continue to harp on GARDASIL.

抱歉，我繼續喋喋不休地談論 GARDASIL。

But just, I guess, given the situation in China, you guys are less willing to predict the timing of recovery.

但我想，考慮到中國的情況，你們不太願意預測復甦的時間。

But I guess the question, Rob, is, is there an inventory threshold that you need to see to start shipping again?

但是羅布，我想問題是，是否存在一個庫存門檻，你需要看到這個門檻才能再次開始出貨？

I wasn't sure what the -- what kind of the tipping point would be for that.

我不確定那件事的臨界點是什麼。

And maybe more broadly, just given the political climate towards vaccines overall, maybe just talk about where this TA falls in your BD or internal R&D priorities, if that's changed at all.

也許從更廣泛的角度來看，考慮到整個疫苗的政治氣候，也許只是討論這個 TA 在你的 BD 或內部研發優先事項中的位置（如果有的話）。

Yeah.

是的。

Geoff, thanks for the comments.

傑夫，謝謝你的評論。

So on China, in particular, there's not a -- I don't want to commit to a specific inventory level.

因此，特別是在中國，我不想承諾特定的庫存水準。

Obviously, we need to see it come down meaningfully from where it is.

顯然，我們需要看到它從目前的狀態有意義地下降。

And I think by taking this action to stop shipments given the demand that's there, we're going to see that happen.

我認為，考慮到存在的需求，採取這一行動停止發貨，我們將看到這種情況發生。

We just have to let it work itself through.

我們只需讓它自行解決即可。

Because the economy there's still is soft, and that has led to the fact that we are seeing consumer demand continue to be weak.

因為那裡的經濟仍然疲軟，這導致我們看到消費需求持續疲軟。

And so as that situation resolves, I think that will determine the speed with which all of this happens.

因此，隨著這種情況的解決，我認為這將決定所有這一切發生的速度。

But I think it's important to just reemphasize, going forward, by rebasing this now out, this is upside.

但我認為，重要的是再次強調，展望未來，透過重新確定這一點，這是有利的。

This is not a core to our growth story going forward.

這不是我們未來成長故事的核心。

And so that is also what we want to make sure people understand.

這也是我們希望人們理解的。

I recognize it's a big change.

我認識到這是一個巨大的變化。

And we want to do and we will do everything -- we are very committed and positioned well to drive growth in China.

我們希望並且將盡一切努力——我們非常致力於並準備好推動中國的成長。

But to me, at this point, that will be upside for the company.

但對我來說，就目前而言，這對公司來說是件好事。

And beyond that, the breadth of what we have will drive the growth in oncology, in Animal Health, and with our new launches.

除此之外，我們廣泛的產品範圍將推動腫瘤學、動物保健以及新產品的推出。

To the vaccines business more broadly, we continue to believe in vaccines as an important area.

就更廣泛的疫苗業務而言，我們仍然相信疫苗是一個重要領域。

Obviously, we have CAPVAXIVE, which is launching as we speak.

顯然，我們有 CAPVAXIVE，它正在推出。

We have clesrovimab, a monoclonal antibody for RSV, that we hope to get approval and see come before the RSV season this year.

我們有針對呼吸道合胞病毒 (RSV) 的單株抗體 clesrovimab，希望它能在今年呼吸道合胞病毒 (RSV) 季節之前獲得批准並上市。

And then we have other programs in development, including dengue is probably one of the most significant other ones.

我們還有其他項目正在開發中，其中登革熱項目可能是其中最重要的項目之一。

So we continue to focus there.

因此我們將繼續關注那裡。

I wouldn't say that vaccines is a big focus of our BD strategy primarily because we just haven't seen that many opportunities in the space.

我不會說疫苗是我們 BD 策略的重點，主要是因為我們還沒有看到該領域的那麼多機會。

But we are continuing to be committed to driving the R&D we're doing in this space going forward and continue to believe there's opportunity for it.

但我們將繼續致力於推動該領域的研發工作，並繼續相信該領域的發展機會。

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特 (Chris Schott)。

Another one on GARDASIL.

又一個關於 GARDASIL 的。

Specific to the long-term guidance, I totally understand the near-term dynamics need to reduce inventory.

具體到長期指導，我完全理解短期內減少庫存的需要。

But the removal of the $11 billion target is -- how much of this is conservatism just given the dynamics of China versus this being a more permanent reset of your view on the Chinese market?

但取消 110 億美元的目標——考慮到中國的動態，這在多大程度上是保守主義的體現，還是對中國市場看法的更永久的重新調整？

I'm trying to get my hands around that.

我正盡力解決它。

And then as part of that answer, maybe just talk about GARDASIL ex-China.

然後作為答案的一部分，也許只談論中國以外的 GARDASIL。

Has there been any change in your longer-term views on the global opportunity ex-China for the product?

您對該產品在中國以外地區的全球機會的長期看法有什麼變化嗎？

Yeah.

是的。

No, thanks for the question, Chris.

不，謝謝你的提問，克里斯。

So as you look at China, as Caroline said in the prepared remarks, we continue to believe there's a path to the $11 billion but feel it's prudent really to withdraw the target right now.

因此，當你看中國時，正如卡羅琳在準備好的發言中所說的那樣，我們仍然相信有一條通往 110 億美元的道路，但覺得現在撤回目標確實是明智之舉。

Because it is uncertain, both the timing of the recovery in China and the extent.

因為中國復甦的時間和程度都不確定。

That being said, if you look at the underlying dynamics that had always caused us to believe in the growth in China, they're still there.

話雖如此，如果你觀察一下讓我們一直相信中國經濟能夠成長的潛在動力，你會發現它們仍然存在。

We still have the 100 million-plus women, 120 million women, who have yet to be vaccinated in the Tier 1 to 5 cities.

我們一到五線城市還有1億多女性，1.2億名女性尚未接種疫苗。

We have the male indication where we are the only company with that indication, and we're launching that as we speak.

我們擁有針對男性的適應症，我們是唯一一家擁有該適應症的公司，我們正在推出這個適應症。

And obviously, that is a population about the same size as female.

顯然，該群體的規模與女性群體的規模大致相同。

It's about 200 million if you look in the total potential once we're in that marketplace.

如果你看一下我們進入該市場後的總潛力，它大約有 2 億。

So the opportunity is there.

因此機會是存在的。

We have the near-term dynamics of the inventory and the near-term dynamics of the economy we need to adjust.

我們有庫存的近期動態，也有需要調整的經濟的近期動態。

That is why I think it's prudent to just say until we see that, because China was a meaningful part of the $11 billion, that's why we made the decision to say, let's pull back on the $11 billion.

這就是為什麼我認為明智的做法是，等到我們看到這一點後再說，因為中國是這 110 億美元中的重要一部分，這就是為什麼我們決定說，讓我們撤回這 110 億美元。

As we look at every other market around the world, for the rest of the world, our view remains unchanged.

當我們觀察世界各地的其他市場時，對於世界其他地區，我們的觀點保持不變。

And as Caroline pointed out, if you exclude GARDASIL China, we had strong double-digit growth this year, again, in the rest of the world.

正如卡羅琳所指出的，如果不包括 GARDASIL 中國，今年我們在世界其他地區也實現了強勁的兩位數成長。

And as we look forward, if you exclude China, we have strong growth coming in GARDASIL every year, year on year.

展望未來，如果不考慮中國，GARDASIL 的銷量每年都會實現強勁成長。

So nothing has changed in our long-term view.

因此，從我們的長期觀點來看，沒有任何改變。

We need to get the China situation figured out.

我們需要弄清楚中國的情況。

We need to lap this market dynamic and figure out what the actual growth and opportunity is in China.

我們需要了解這個市場動態，並找出中國的實際成長和機會。

And until we do that, I just want to remove this from the dialogue.

在我們這樣做之前，我只想將其從對話中刪除。

Because by continuing to always come back to this, I feel like we missed so much else we have in the strength of our pipeline and in the growing breadth of our business.

因為透過不斷地回到這個問題，我感覺我們錯過了很多其他我們擁有的管道實力和不斷增長的業務廣度。

That is really the fundamentals of our growth long term, has been and will continue to be.

這確實是我們長期成長的基礎，過去是、現在也是、未來也將繼續是。

And I want to get people focused there because that's where we're focused.

我希望讓人們把注意力集中在那裡，因為那是我們關注的重點。

Tim Anderson, Bank of America.

美國銀行的蒂姆·安德森。

A couple of questions on KEYTRUDA.

關於 KEYTRUDA 的幾個問題。

So I don't think GARDASIL would have impacted the stock as much as it has over the last six months had it not been for these underlying concerns about KEYTRUDA going into the IRA in '28, going off patent at the end of '28.

因此，我認為，如果不是因為人們對 KEYTRUDA 在 1928 年進入 IRA 以及在 1928 年底專利到期存在擔憂，GARDASIL 不會對股價產生像過去六個月那樣大的影響。

So my first question is, when can we expect Merck will be in a position to talk about longer-term forward-looking guidance like a lot of other companies that address this period?

所以我的第一個問題是，我們什麼時候可以預期默克能夠像許多其他公司一樣談論長期前瞻性指導？

At the moment, you're saying, you can successfully navigate period, there's no quantification.

目前，您說您可以成功駕馭這段時期，但無法量化。

And I would argue that the latter is needed.

我認為後者是必要的。

And then a second question is near-term KEYTRUDA, investors worried about two competitor readouts in '25 that take on KEYTRUDA head to head.

第二個問題是近期的 KEYTRUDA，投資人擔心 25 年會出現兩款與 KEYTRUDA 正面交鋒的競爭對手。

The first is Astra's AVANZAR trial with Enhertu.

首先是 Astra 與 Enhertu 合作進行的 AVANZAR 試驗。

The second is the SUMMIT data with the PD-1/VEGF.

第二個是含有PD-1/VEGF的SUMMIT資料。

It would be great to get any perspective from Dean on these two readouts.

非常希望能聽聽 Dean 對這兩份報告的看法。

What's the realistic worst-case scenario?

現實的最壞情況是什麼樣的？

Yeah.

是的。

Tim, thanks for the question.

提姆，謝謝你的提問。

And as you pointed out, I recognize the focus is on what happened post the LOE.

正如您所指出的，我認識到焦點在於 LOE 之後發生的事情。

And we've tried to give direction.

我們也盡力給予指導。

I think if you go back to what we said at JPMorgan, we were pretty clear in what we see.

我想，如果你回顧我們在摩根大通所說的話，我們對所看到的情況非常清楚。

And that is if you look at the combination of the business development and the advances in our pipeline across oncology -- and this is excluding anything to do with KEYTRUDA.

如果您綜合考慮業務發展和我們在腫瘤學領域的研發管線進展 — — 這還不包括與 KEYTRUDA 相關的任何內容。

So these are small molecules, the individualized neoantigen therapy, and our ADC portfolio, combined with ophthalmology, with what we see in HIV, with cardiometabolic as -- you can see the whole list there.

因此，這些是小分子、個人化新抗原治療和我們的 ADC 產品組合，結合眼科、我們在 HIV 中看到的以及心臟代謝——您可以在那裡看到整個清單。

We have $50 billion-plus of what we see as potential.

我們認為其潛在價值超過 500 億美元。

So that's why we continue to talk about a hill versus a cliff, and that -- my confidence in that growth trajectory we showed is still there.

所以這就是為什麼我們繼續談論山丘與懸崖，而且我對我們所展示的成長軌跡仍然充滿信心。

We have not decided if and when we will give long-term guidance.

我們尚未決定是否以及何時提供長期指導。

That's always a two-edged sword, and I think we need to be thoughtful about that.

這始終是一把雙刃劍，我認為我們需要對此深思熟慮。

But I also recognize as we move through time, we need to continue to give proof points like what we're seeing with CapEx, like what we're seeing with WINREVAIR, and like what we are confident you're going to see as enlicitide and the data for that start to flow through and other products we have been coming down the pipe.

但我也意識到，隨著時間的推移，我們需要繼續提供證據，就像我們在 CapEx 中看到的那樣，就像我們在 WINREVAIR 中看到的那樣，就像我們確信你們會看到的那樣這些數據開始流通，其他產品也開始流入我們的管道。

Those proof points are what are going to bring confidence over time.

隨著時間的推移，這些證明點將會給人們帶來信心。

But I hear you on the guidance, and we will reflect on that.

但我聽取了您的指導，我們將對此進行反思。

But we do not have a plan right now to do that.

但我們目前還沒有這樣的計畫。

Yeah.

是的。

This is Dean.

這是迪恩。

I'll just answer in relationship to the Daiichi Sankyo TROP2-ADC that you referenced, we're very comfortable about our TROP2 program.

我只想回答您提到的第一三共 TROP2-ADC，我們對我們的 TROP2 計劃非常滿意。

As you might know in our Phase 3 clinical trials, we have 10 ongoing.

您可能知道，我們目前正在進行 10 項 3 期臨床試驗。

And so we're very eager to have those move forward and we're confident in them.

因此，我們非常渴望這些工作能夠取得進展，我們對此充滿信心。

In relationship to the VEGF/PD-1 that you spoke about, I mean, I would just say combination PD-1 and VEGF independently have been extensively studied by us in combination with Eisai and by other companies as well.

關於您提到的 VEGF/PD-1，我想說的是，我們已經與 Eisai 和其他公司聯合對 PD-1 和 VEGF 的組合進行了廣泛的研究。

And there is a general sense that there are many examples of improved progression-free survival that don't have a pattern of consistently hitting translatability to OS.

並且普遍認為，有許多無惡化存活期改善的例子，但沒有形成持續達到 OS 的可轉化模式。

And I think important work by others suggest that maybe there's increased PFS for PD-1 or PD-L1/VEGF.

我認為其他人的重要研究表明 PD-1 或​​ PD-L1/VEGF 的 PFS 可能會增加。

And that needs to demonstrate OS.

這需要演示操作系統。

But the way that we look at that is that Merck is uniquely positioned to explore this and an advantaged company that could really figure out whether VEGF/PD-1 is going to give you OS benefit.

但我們的看法是，默克公司在探索這一領域具有獨特的優勢，並且是一家能夠真正弄清楚 VEGF/PD-1 是否會為您帶來 OS 益處的優勢公司。

And if it does, we have the infrastructure based on 41 indications in 18 tumor types, nine in earlier stage and four with OS, to really rapidly bring this innovation should lead to OS to many patients and many cancers.

如果確實如此，我們已經擁有基於18 種腫瘤類型的41 種適應症的基礎設施，其中9 種處於早期階段，4 種處於OS，能夠真正快速地將這一創新帶給許多患者和許多癌症，從而讓它們獲得OS。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞（Jefferies）。

Just kind of building on the last one, your team recently updated your new product guidance for oncology from $20 billion to $25 billion despite the recent failures we've seen from both TIGIT and LAG3.

基於上一條，儘管最近 TIGIT 和 LAG3 都失敗了，但您的團隊最近仍將腫瘤學新產品指導價從 200 億美元更新到了 250 億美元。

What are the ballpark components of that $25 billion figure, particularly for the TROP2 and the Daiichi ADCs?

250 億美元這個數字的大概組成部分是什麼，特別是對於 TROP2 和第一核動力 ADC 來說？

And Dean, where do you think your TROP2 strategy differs versus Astra with data?

那麼 Dean，您認為您的 TROP2 策略與 Astra 的數據有何不同？

Are there any particular biomarker populations where you feel like Merck will win out for both first- and second-line lung?

您是否認為默克公司將在一線和二線肺癌治療領域中勝出的特定生物標記群體？

Hey, Akash.

嘿，阿卡什。

Thanks for the question.

謝謝你的提問。

So as you look at what makes up the $25 billion, to be clear, the IO-IO combinations were never part of that.

因此，當你查看這 250 億美元的組成時，要明確的是，IO-IO 組合從來都不是其中的一部分。

So those were always supplemental to that.

所以這些總是對此進行補充。

The $25 billion was made up of the antibody drug conjugate programs we have both from Kelun and from Daiichi Sankyo, as well as a suite of small molecule deals we did mostly in target and molecular approaches to cancer.

這 250 億美元資金來自我們從科倫和第一三共獲得的抗體藥物偶聯項目，以及我們主要針對癌症的目標和分子方法進行的一系列小分子交易。

This would be the -- if you will, the LSD1, the CYP11A1, all of those suite of programs we had, the INT, which is the individualized neoantigen therapy and -- which is the partnership we have with Moderna.

如果你願意的話，這將是 LSD1、CYP11A1、我們擁有的所有這些程序套件、INT，即個性化的新抗原療法，以及——這是我們與 Moderna 建立的合作夥伴關係。

That made up the numbers.

這就是數字。

What changed that allowed us to increase our confidence is two things.

有兩件事讓我們增強了信心。

One, we added the T cell engager from Harpoon, which we're very excited about, both as a standalone and potentially in combination as we look at small cell lung cancer.

首先，我們添加了 Harpoon 的 T 細胞接合劑，我們對此感到非常興奮，在我們研究小細胞肺癌時，它既可以單獨使用，也可以潛在地聯合使用。

And most importantly, the TROP2 program we have is, we think, going to be even more successful than we originally thought as we continue to see the data read out there.

最重要的是，我們認為，隨著我們不斷看到讀取的數據，我們的 TROP2 計劃將比我們最初想像的更加成功。

So we feel very good about that $25-plus billion number.

因此，我們對 250 多億美元這個數字感到非常滿意。

And then separate from that, just to be -- it's important.

然後將其與此分開，只是為了——這很重要。

We still are also very confident in our subcu KEYTRUDA, which as we pointed out at JPMorgan, we will be -- you'll see data readouts.

我們仍然對我們的子藥物 KEYTRUDA 非常有信心，正如我們在摩根大通指出的那樣，我們將 - 您將看到數據讀數。

It will be filed this year and hopefully, potentially, even launched yet this year.

它將於今年提交申請，並預計今年推出。

So that is something we continue to also be very confident about.

因此，我們對此仍然充滿信心。

That is not in that $25-plus billion.

這還不在那250多億美元之內。

So that's important.

所以這很重要。

We will be much greater than that in oncology when you look at the totality of what we will have.

從整體來看，我們在腫瘤學領域的成就將遠遠超過這個數字。

Yeah.

是的。

So I'll just answer as quickly as I possibly can.

因此我會盡快回答。

One of the things I would just be a little bit cautious is when everyone speaks about TROP2 or HER2 ADC that all the molecules are the same.

我要稍微謹慎一點的是，當每個人都談論 TROP2 或 HER2 ADC 時，所有分子都是相同的。

The molecules are quite different.

這些分子有很大不同。

We've already seen that with Catella and in HER2.

我們已經在 Catella 和 HER2 中看到了這一點。

And the same thing can be true when you look at ADCs the same target.

當您將 ADC 視為相同目標時，同樣的事情也會發生。

So we're very confident of our SAC-TMT in the design.

因此，我們對我們的 SAC-TMT 設計非常有信心。

But also early on, one of the things that we've always said is it's important to hit the right target population.

但在早期，我們一直在說的一件事就是，瞄準正確的目標族群非常重要。

Chemo plus pembro has a broad impact.

化療加帕姆布林治療影響廣泛。

And every trial that we do, we ask ourselves what patient population would a SAC-TMT or any ADC will be distinguished from that baseline.

我們在每次試驗中都會問自己，SAC-TMT 或任何 ADC 與基線相比會有哪些患者群體不同。

In relationship to the other Daiichi Sankyo ones, patritumab, we're very interested in relationship to breast.

相對於第一三共的其他藥物 patritumab，我們對它與乳房的關係非常感興趣。

The B7-H3, we're very interested in small cell lung cancer.

B7-H3，我們對小細胞肺癌非常感興趣。

CDH6, we're very interested in ovarian.

CDH6，我們對卵巢非常感興趣。

And we're very interested in mixing and matching some of them with T cell engagers.

我們對將它們中的一些與 T 細胞接合體進行混合和搭配非常感興趣。

I do just want to make a call-out just in relationship to the design of the Kelun as well as the Daiichi Sankyo.

我只是想就科倫和第一三共的設計提出一點意見。

That's really, I think, important molecules that we think if we hit the right patient population and combine them with the right IO strategy, whether it be T cell engagers or PD-1s, that we will have differentiated profiles for patients.

我認為，這些分子確實很重要，如果我們找到正確的患者群體，並將它們與正確的 IO 策略相結合，無論是 T 細胞接合劑還是 PD-1，我們都會為患者提供差異化治療方案。

Trung Huynh, UBS.

瑞銀 (UBS) 的 Trung Huynh。

I just wanted to ask on the tariff news we saw emerge over the weekend.

我只是想問一下我們週末看到的關稅消息。

So can you perhaps talk about your manufacturing footprint from China, Mexico, and Canada?

那麼您能談談您在中國、墨西哥和加拿大的製造足跡嗎？

And there were also some discussions on the -- from the administration on transfer pricing.

政府部門也對轉讓定價進行了一些討論。

So your IP for KEYTRUDA is based out of Ireland.

所以您的 KEYTRUDA IP 位於愛爾蘭之外。

How much of an impact could that have on the -- if transfer pricing is also targeted?

如果轉讓定價也成為目標，那麼這會有多大影響？

Thank you for the question, Trung.

謝謝你的提問，Trung。

Our company, like many other companies, has a manufacturing footprint that really enables global supply.

我們公司和許多其他公司一樣，擁有真正實現全球供應的製造足跡。

We have very low levels of manufacturing happening in China, in Mexico, and Canada.

中國、墨西哥和加拿大的製造業水準非常低。

So we'd expect a very immaterial impact from tariffs that were proposed over the weekend for those countries.

因此，我們預計週末針對這些國家提出的關稅影響不會太大。

We will continue to assess the situation based on the different tariffs that are being proposed by the US government but remain confident in our supply chain and our ability to supply our medicines and vaccines around the world.

我們將繼續根據美國政府提出的不同關稅來評估情勢，但我們對我們的供應鏈以及在全球範圍內供應藥品和疫苗的能力仍然充滿信心。

Vamil Divan, Guggenheim.

瓦米爾迪萬（Vamil Divan），古根漢。

Maybe just going back to WINREVAIR.

也許只是回到 W​​INREVAIR。

Obviously, you have the positive news on the ZENITH and HYPERION.

顯然，你們對 ZENITH 和 HYPERION 有正面的消息。

Just curious if it's changed in any way your expectations for Cadence.

只是好奇它是否以某種方式改變了您對 Cadence 的期望。

I think that's maybe underappreciated event later this year and other different indications.

我認為這可能是今年稍後被低估的事件以及其他不同的跡象。

But just, I guess, Dean, curious if there's any read-through we should be mean from the success you're having there.

但是，我想，迪恩，我只是好奇，從你在那裡的成功來看，我們是否應該有所了解。

And then tied to that, if you can just comment if there's any inventory fluctuation.

然後與此相關，如果您可以評論是否存在任何庫存波動。

I think it's impacted the sales number the first couple of quarters.

我認為這對前幾季的銷售數字產生了影響。

So just want to understand if it impacted WINREVAIR this past quarter.

所以只是想了解它是否對上個季度的 WINREVAIR 產生了影響。

Yeah.

是的。

So I'll just take the WINREVAIR question in relationship to the different patient population.

因此，我只想結合不同患者群體來探討 WINREVAIR 問題。

So patients who have pulmonary hypertension can have pulmonary hypertension because they have PAH.

因此，患有肺動脈高壓的患者可能會因為患有肺動脈高壓而出現肺動脈高壓。

And what I would say is my confidence of WINREVAIR as to potentially reshaping the standard of care in the treatment paradigm for PAH is very high, especially since this molecule is designed at the genetic cause of the disease.

我想說的是，我對 WINREVAIR 可能重塑 PAH 治療模式的護理標準非常有信心，尤其是因為這種分子是針對該疾病的遺傳原因設計的。

We are looking at broader implications of that because there are other ways that you can get pulmonary hypertension besides PAH, and we are very eager to see what it does in relationship to a heart failure population.

我們正在研究這個問題的更廣泛的含義，因為除了肺動脈高壓 (PAH) 之外，還有其他途徑可以導致肺動脈高壓，我們非常渴望了解它與心臟衰竭族群的關係。

And so we'll have to see those results.

所以我們必須看到這些結果。

The preclinical data suggests that that's an important experiment for us to do, and we're eager to push that forward.

臨床前數據顯示這對我們來說是一項重要的實驗，我們渴望推動其向前發展。

And we're excited to see the results.

我們很高興看到結果。

And in terms of inventory for WINREVAIR, we have not seen anything unusual.

就 WINREVAIR 的庫存而言，我們沒有發現任何異常。

Inventory levels were normal as we exited the year.

今年結束時庫存水準恢復正常。

And in the quarter, we did include an adjustment for the value of the inventory in the channel given the Medicare Part D redesign.

並且在本季度，考慮到醫療保險 D 部分的重新設計，我們確實對通路中的庫存價值進行了調整。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

I just wanted to clarify two things.

我只是想澄清兩件事。

The first was just coming back to GARDASIL.

第一個是剛接種 GARDASIL。

And I know there's been a lot of conversation around that.

我知道人們已經就此進行了大量討論。

Can you please kind of provide specificity as to whether there's any risk of write-off as we think about the inventory that's sitting in the channel at Zhifei and the age of the inventory?

您能否具體說明一下，考慮到智飛通路中的庫存以及庫存年限，是否有註銷風險？

And then the second question around Part D redesign.

然後第二個問題是關於 D 部分重新設計。

I know you just mentioned specifically about WINREVAIR and the channels' dynamics there.

我知道您剛才特別提到了 WINREVAIR 以及那裡的通路動態。

But as you're thinking about 2025 and some of the guidance that peer companies are beginning to give, and we've seen different ranges and different interpretations, can you just give some context as to what you've baked in in terms of volume relative to price as we think about the $400 million guidance?

但是，當您考慮 2025 年以及同行公司開始給出的一些指導時，我們看到了不同的範圍和不同的解釋，您能否提供一些背景信息，說明在考慮 4 億美元的指導時，您在數量與價格方面考慮了什麼？

Thank you, Courtney.

謝謝你，考特尼。

In terms of GARDASIL inventory, we are, as Rob said, pausing shipments to enable Zhifei to utilize that inventory in the market, and that's inventory that our partner owns.

就 GARDASIL 庫存而言，正如 Rob 所說，我們暫停發貨，以便智飛能夠在市場上利用這些庫存，而這些庫存是我們合作夥伴擁有的。

So the risk for write-off of inventory from Merck is extremely low.

因此，默克庫存註銷的風險極低。

In terms of Part D redesign, what you have are the two dynamics.

就 D 部分重新設計而言，您擁有兩種動力。

The first is the price impact.

首先是價格影響。

And as noted in our prepared remarks, that predominantly impacts WINREVAIR as well as our oral oncology agents.

正如我們在準備好的評論中指出的那樣，這主要影響 WINREVAIR 以及我們的口服腫瘤藥物。

That, we think, will be partially offset with some volume benefit as patients stay on therapy.

我們認為，隨著患者繼續接受治療，這一損失將透過一定程度的治療量效益而部分抵消。

But the majority of the $400 million that we noted is really the pricing impact.

但我們注意到的 4 億美元中的大部分實際上是定價影響。

We have time for one final question, please, Shirley.

雪莉，我們還有時間問最後一個問題。

James Shin, Deutsche Bank.

德意志銀行的詹姆斯辛 (James Shin)。

Sorry about that, just making sure.

很抱歉，只是想確認一下。

Technical difficulties.

技術困難。

Don't mean to belabor the GARDASIL topic, but there is an upcoming February 2025 ACIP meeting, and the agenda suggests there's some follow-up on last October's dosing questions.

我不想過多地討論 GARDASIL 主題，但 2025 年 2 月將召開一次 ACIP 會議，而且議程表明將對去年 10 月的劑量問題進行一些後續討論。

Can you level set us on the expectations from this February session?

您能為我們概述一下二月會議的預期嗎？

And relative to the long-term guide of GARDASIL, did the US market play any role in that change the guidance or guidance being withdrawn?

相對於 GARDASIL 的長期指導，美國市場在改變指導或撤銷指導方面是否發揮了任何作用？

Yeah.

是的。

Maybe I'll take the second part of the question, and Dean can take the first part.

也許我會回答問題的第二部分，而 Dean 可以回答第一部分。

No, no change.

沒有，沒有變化。

So as we said earlier, if you exclude China, our expectations for the rest of the world, which would include the US, are unchanged.

因此，正如我們之前所說，如果排除中國，我們對包括美國在內的世界其他國家的預期將保持不變。

So there's no change in our long-term belief in GARDASIL from that regard.

因此從這個角度來看，我們對 GARDASIL 的長期信念並沒有改變。

As it relates to the ACIP and the dosing question, we're going to have to wait and see where it is.

由於它與 ACIP 和劑量問題有關，我們將不得不拭目以待。

We continue to believe that the strength of the clinical data supports the two- and three-dose regimen we have today.

我們仍然相信，充足的臨床數據支持我們今天所採用的兩劑和三劑方案。

It's a very high bar, and I'll let Dean comment maybe on some from the FDA and our perspectives.

這是一個非常高的標準，我會讓 Dean 從 FDA 和我們的角度對一些內容做出評論。

But I think we need to see where it goes, but we continue to feel very strongly that the dosing is appropriate and do not necessarily see that as a risk in the US.

但我認為我們需要觀察其走向，但我們仍然強烈地認為劑量是合適的，並且不一定認為這在美國有風險。

But I'll let Dean comment.

但我會讓 Dean 發表評論。

Yeah.

是的。

So the way that I would look at it, ACIP is CDC.

因此，從我的角度來看，ACIP 就是 CDC。

The label is FDA.

標籤是 FDA。

Scheduling dose is the FDA.

安排劑量是 FDA。

And I would just say that the dosing schedule of GARDASIL has been rigorously vetted by the FDA.

我只想說，GARDASIL 的給藥時間表已經經過 FDA 的嚴格審查。

And as you've seen, as we've gone from three doses and two doses, the evidentiary proof that is required by the FDA to change scheduling is high.

正如您所看到的，隨著我們從三劑變為兩劑，FDA 改變安排所需的證據證明很高。

I should also emphasize that we have been in discussions with the FDA in relationship to how do we create and reach a randomized controlled trial that could change schedules for GARDASIL/GARDASIL-9 in men and in women.

我還要強調的是，我們一直在與 FDA 討論如何創建並達成一項隨機對照試驗，以改變男性和女性使用 GARDASIL/GARDASIL-9 的時間表。

And the FDA, as you might imagine, has a very high bar for that proof.

正如你可能想的，FDA 對於這種證明有著非常高的標準。

Now I would surmise that the remarkable history of efficacy and safety influences the FDA's high standards and rigorous standards for anyone to want to change the label.

現在我推測，卓越的功效和安全性歷史影響了 FDA 對任何想要更改標籤的人的高標準和嚴格標準。

I can't speak to what will happen, but I might suspect, especially now, that the deep attention and expertise of the FDA on dosing and scheduling might be important to the CDC as they decide how -- decide on this question of creating a schedule that is outside of the label from the FDA.

我不能說會發生什麼，但我可能會懷疑，特別是現在，FDA 對劑量和時間安排的高度關注和專業知識可能對 CDC 很重要，因為他們會決定如何——決定如何創建一個超出FDA 標籤的時間表。

Great.

偉大的。

Thanks, Dean.

謝謝，迪恩。

Thanks, James.

謝謝，詹姆斯。

Rob, a couple of comments to close the call?

Rob，您還有什麼話要說嗎，可以結束通話了？

Yeah.

是的。

Well, thank you all for your time on the call.

好吧，非常感謝大家接受我們的電話訪問。

Just maybe to end the call, I just want to reinforce our confidence in the long term.

也許是為了結束通話，我只是想增強我們的長期信心。

I recognize the GARDA situation in China is a change.

我認識到中國 GARDA 的情況發生了變化。

I think it's the right decision we're making now to put this behind us to resolve this inventory situation and move forward.

我認為我們現在做出的正確決定是拋開這個問題，解決庫存問題，然後繼續前進。

But putting -- that's a short-term event.

但推桿——那是一個短期事件。

Putting it in context of the long term of this company, as we said, we see strong growth in the second half of the year leading into 2026 into 2027.

正如我們所說，從公司的長期發展來看，我們預計今年下半年至 2026 年及 2027 年將出現強勁成長。

And importantly, as we look to the period beyond, the strength of the pipeline, the diversity of the pipeline, the progress of the pipeline is profound.

重要的是，當我們展望未來時，管道的實力、管道的多樣性、管道的進步都是深刻的。

And I really believe that once we fully understand all of that, and I recognize it's going to take proof points in time, you'll understand why we have the confidence we do in the long term.

我真的相信，一旦我們完全理解了所有這些，並且我認識到這需要時間的證明，你就會明白為什麼我們對長期目標有信心。

And we are committed to demonstrating that and, most importantly, to continue to advance that pipeline for the patients we serve.

我們致力於證明這一點，最重要的是，我們將繼續為我們服務的患者推進此管道。

So with that, I'll close the call.

好了，我要結束本次通話了。

Thank you.

謝謝。