默克藥廠 (MRK) 2023 Q4 法說會逐字稿

Thank you for standing by. Welcome to the Merck & Co. Q4 Sales and Earnings Conference Call. (Operator Instructions) This call is being recorded. If you have any objections, you may disconnect at this time.

謝謝你的支持。歡迎參加默克公司第四季銷售和收益電話會議。 （操作員說明）此通話正在錄音。如果您有任何異議，您可以此時斷開連接。

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

我現在想將電話轉給投資者關係副總裁 Peter Dannenbaum 先生。先生，您可以開始了。

Thank you, Ivy, and good morning, everyone. Welcome to Merck's Fourth Quarter 2023 Conference Call. 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.

謝謝艾維，大家早安。歡迎參加默克 2023 年第四季電話會議。董事長兼執行長 Rob Davis 將在今天的電話會議上發表演說；卡洛琳‧利奇菲爾德，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 a few items. You will see that we have items in our GAAP results, such as acquisition-related charges, restructuring costs and certain other items. You should note that we have excluded these from our non-GAAP results and provide a reconciliation in our press release.

在開始之前，我想指出一些事項。您將看到我們的 GAAP 結果中有一些項目，例如收購相關費用、重組成本和某些其他項目。您應該注意到，我們已將這些數據排除在我們的非公認會計準則績效之外，並在我們的新聞稿中提供了調節表。

I would like to 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 U.S. Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of Merck'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.

我想提醒您，我們今天所做的一些陳述可能被視為 1995 年美國私人證券訴訟改革法案安全港條款含義內的前瞻性陳述。此類陳述是基於當前的信念而做出的。默克管理層的責任，並面臨重大風險和不確定性。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提出的結果有重大差異。

Our SEC filings, including Item 1A and the 2022 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements.

我們向SEC 提交的文件（包括第1A 項和2022 年10-K）確定了某些風險因素和警告性聲明，這些因素和警告性聲明可能導致公司的實際結果與我們今天早上做出的任何前瞻性聲明中的預測存在重大差異。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. 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.

在今天的電話會議中，我們的演講者準備好的演講將附有幻燈片演示。這些投影片以及收益發布、今天準備的評論和我們向 SEC 提交的文件均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.

有了這個，我想把電話轉給羅布。

Thanks, Peter. Good morning and thank you for joining today's call. 2023 was another very strong year for Merck. I'm extremely pleased by the progress we've made to develop and deliver transformative therapies and vaccines that will help save and improve lives around the world. We reached more than 500 million people with our medicines last year alone, over half of which were through donations.

謝謝，彼得。早安，感謝您參加今天的電話會議。 2023 年對默克來說又是非常強勁的一年。我對我們在開發和提供變革性療法和疫苗方面取得的進展感到非常高興，這些療法和疫苗將有助於拯救和改善世界各地的生活。光是去年，我們就向超過 5 億人提供了藥品，其中超過一半是透過捐贈獲得的。

We also made substantial investments in research and development in our ongoing effort to discover and bring forward to patients the next generation of impactful innovations, over $30 billion in total, including the cost of certain acquisitions and collaborations.

我們也在研發方面進行了大量投資，不斷努力發現並向患者帶來下一代有影響力的創新，總投資超過 300 億美元，其中包括某些收購和合作的成本。

As we move forward, I'm confident that our strong momentum will continue, underpinned by the unwavering dedication of our talented global team.

隨著我們不斷前進，我相信，在我們才華橫溢的全球團隊堅定不移的奉獻精神的支撐下，我們的強勁勢頭將繼續下去。

We're realizing the benefits of our sustained focus on key strategic priorities. The excellence of our commercial and operational execution enables us to deliver tangible value in the short term, while we invest in new innovations and strengthen our pipeline for the long term.

我們正在認識到持續專注於關鍵策略優先事項的好處。我們卓越的商業和營運執行力使我們能夠在短期內提供有形的價值，同時我們投資於新的創新並加強我們的長期管道。

In 2023, we advanced important clinical programs and augmented our pipeline with promising business development, such as the acquisition of Prometheus and our collaboration with Daiichi Sankyo. Guided by our science-led strategy, I'm confident that the focused and disciplined business decisions we make and the actions we take will lead to sustainable benefits for the patients we serve and long-term growth and value for our shareholders.

2023 年，我們推動了重要的臨床項目，並透過有前景的業務發展擴大了我們的產品線，例如收購 Prometheus 以及與第一三共的合作。在我們以科學為主導的策略的指導下，我相信，我們做出的專注且嚴格的業務決策以及我們採取的行動將為我們所服務的患者帶來可持續的利益，並為我們的股東帶來長期成長和價值。

Turning to our results and initial outlook for 2024. We delivered excellent underlying growth in 2023, reflecting robust demand for our innovative portfolio. I'm pleased to share that we expect continued strong growth in 2024, driven by demand for our products, which Caroline will speak to momentarily.

談到我們 2024 年的業績和初步展望。我們在 2023 年實現了出色的基礎成長，反映出對我們創新產品組合的強勁需求。我很高興地告訴大家，在對我們產品的需求的推動下，我們預計 2024 年將繼續強勁增長，卡羅琳將立即談到這一點。

Turning to the progress we're making in research. We're currently pursuing programs across a more diverse set of therapeutic areas with high unmet need and across more modalities than at any time in recent memory. This year, we will remain keenly focused on advancing our broad and diverse pipeline, which includes 2 launches that will address critical health needs and have blockbuster commercial opportunity.

轉向我們在研究方面取得的進展。我們目前正在更多樣化的治療領域開展項目，這些領域的需求未被滿足，並且涉及的模式比近期記憶中的任何時候都多。今年，我們將繼續專注於推動我們廣泛而多樣化的產品線，其中包括兩項產品的上市，這些產品將滿足關鍵的健康需求並擁有巨大的商業機會。

In cardiometabolic, we're very excited by the anticipated FDA action on our application for sotatercept in the United States, which we believe has the potential to transform the treatment journey for many patients suffering from pulmonary arterial hypertension. Our commercial and manufacturing teams are fully prepared for the strong uptake we expect. Sotatercept is an important component of our growing cardiometabolic pipeline, which we believe has significant long-term potential.

在心臟代謝領域，我們對 FDA 在美國申請 sotatercept 的預期行動感到非常興奮，我們相信這有可能改變許多患有肺動脈高壓的患者的治療歷程。我們的商業和製造團隊已為我們預期的強勁應用做好了充分準備。 Sotatercept 是我們不斷增長的心臟代謝管道的重要組成部分，我們相信它具有巨大的長期潛力。

In vaccines, the FDA accepted for priority review our filing for V116. If approved, V116 would be the first vaccine, specifically designed to address the majority of invasive pneumococcal disease in adults ages 65 and older. Based on its compelling profile, V116 has the potential to become an important new preventative option for adults, and we believe it can achieve majority market share in this setting. We look forward to a potential approval in June.

在疫苗方面，FDA 接受了我們針對 V116 的申請進行優先審查。如果獲得批准，V116 將成為第一種疫苗，專門用於治療 65 歲及以上成年人的大多數侵襲性肺炎球菌疾病。基於其引人注目的特點，V116 有潛力成為成人重要的新預防選擇，我們相信它可以在這種情況下獲得多數市場份額。我們期待六月獲得批准。

And in oncology, we continue to expand into additional tumor types in earlier stages of certain cancers as well as progress our increasingly broad pipeline of novel candidates. We have achieved substantial diversification with a dramatically expanded set of late-stage programs, which Dean will speak to. I'm confident that Merck is well positioned to provide important innovation to patients and sustain its leadership in oncology, well into the future. I know Dean and his team are energized by our progress and are prepared to build on the success we've had in 2023 to further advance Merck's pipeline and bring transformative innovation to patients this year and beyond.

在腫瘤學方面，我們繼續擴展到某些癌症早期階段的其他腫瘤類型，並推進我們日益廣泛的新候選藥物管線。我們已經透過大幅擴展的後期項目實現了實質性的多元化，迪恩將談到這些項目。我相信，默克公司有能力為患者提供重要的創新，並在未來保持在腫瘤學領域的領導地位。我知道 Dean 和他的團隊對我們的進步感到充滿活力，並準備在 2023 年取得的成功的基礎上進一步推進默克的產品線，並在今年及以後為患者帶來變革性創新。

In summary, our science-led strategy, which keeps the patient at the center of everything we do, is delivering important advancements and helping us build a sustainable growth engine for our company. We've made considerable progress over the past year in advancing and expanding our pipeline, which has resulted in substantially increased long-term commercial opportunities.

總之，我們以科學為主導的策略，將患者置於我們所做的一切的中心，正在帶來重要的進步，並幫助我們為公司建立可持續的成長引擎。過去一年，我們在推動和擴大產品線方面取得了長足進步，從而大幅增加了長期商業機會。

We've taken meaningful steps to diversify and position ourselves for sustained leadership in oncology, while also building one of our deepest and broadest pipelines across discovery and development in our recent history outside of oncology and notably in cardiometabolic and immunology.

我們採取了有意義的步驟來實現多元化，並為自己在腫瘤學領域的持續領導地位奠定了基礎，同時還在腫瘤學之外，特別是在心臟代謝和免疫學領域，建立了我們最近歷史上最深入、最廣泛的發現和開發管道之一。

Further, we also expect to benefit from promising late-stage programs across our vaccines, neurosciences, HIV and animal health pipelines, a robust set of early-phase programs and the potential to add exciting innovation through future science-led business development. As a result, we are increasingly confident that we're well positioned to drive patient impact and value creation this year and well into the next decade.

此外，我們還期望受益於疫苗、神經科學、愛滋病毒和動物健康管道等有前景的後期項目、一系列強大的早期項目以及透過未來科學主導的業務發展增加令人興奮的創新的潛力。因此，我們越來越有信心，我們有能力在今年乃至下一個十年推動病患影響力和價值創造。

I would again like to thank our global teams for their commitment to strong research, commercial and operational execution. With a concerted focus on achieving continued excellence, I'm very confident in our ability to deliver short- and long-term stakeholder value. I look forward to providing future updates on our progress and impact.

我要再次感謝我們的全球團隊致力於強有力的研究、商業和營運執行。透過共同致力於實現持續卓越，我對我們提供短期和長期利害關係人價值的能力充滿信心。我期待著在未來提供有關我們的進展和影響的最新資訊。

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

這樣，我就把電話轉給卡洛琳。

Thank you, Rob. Good morning. 2023 was another impactful year for our company. We delivered strong revenue growth of 12%, excluding LAGEVRIO and foreign exchange. Growth was driven by robust performance across Oncology, Vaccines and Animal Health. We remain confident in our ability to continue to deliver strong results in the near term while making disciplined investments in innovative science, which will drive long-term value for patients and shareholders.

謝謝你，羅布。早安. 2023 年對我們公司來說又是具有影響力的一年。我們實現了 12% 的強勁營收成長（不包括 LAGEVRIO 和外匯）。腫瘤學、疫苗和動物健康領域的強勁表現推動了成長。我們仍然相信我們有能力在短期內繼續取得強勁成果，同時對創新科學進行嚴格投資，這將為患者和股東帶來長期價值。

Now turning to our fourth quarter results. Total company revenues were $14.6 billion. Excluding the impact from LAGEVRIO and foreign exchange, the business delivered strong growth of 13%. The following revenue comments will be on an ex-exchange basis.

現在轉向我們第四季的業績。公司總收入為 146 億美元。剔除LAGEVRIO和外匯的影響，該業務實現了13%的強勁成長。以下收入評論將以換算為基礎。

Our Human Health business sustained its momentum. Excluding LAGEVRIO, growth was 14% driven by Oncology and Vaccines. Sales in our Animal Health business increased 4%, driven by companion animal products.

我們的人類健康業務保持了成長勢頭。不包括 LAGEVRIO，腫瘤學和疫苗業務推動了 14% 的成長。在伴侶動物產品的推動下，我們的動物保健業務銷售額成長了 4%。

Turning to the performance of our key brands. In Oncology, sales of KEYTRUDA grew 22% to $6.6 billion. Global growth was driven by increased uptake in earlier-stage cancers, including triple-negative breast cancer and renal cell carcinoma, with particularly strong growth in international markets due to the more recent launches of these important indications. Growth was also driven by the strong global need of patients with metastatic disease.

轉向我們主要品牌的表現。在腫瘤學領域，KEYTRUDA 的銷售額成長了 22%，達到 66 億美元。全球成長是由早期癌症（包括三陰性乳癌和腎細胞癌）的增加所推動的，由於這些重要適應症的最新推出，國際市場的成長尤其強勁。全球轉移性疾病患者的強勁需求也推動了成長。

We continue to be encouraged by the positive impact our recent approvals are having on certain patients with earlier-stage non-small cell lung cancer. In the U.S., we have made considerable progress in helping to improve drug treatment rates and have further increased our leadership position in the adjuvant setting.

我們最近的批准對某些早期非小細胞肺癌患者的積極影響繼續令我們感到鼓舞。在美國，我們在幫助提高藥物治療率方面取得了相當大的進展，並進一步提高了我們在輔助治療領域的領導地位。

We also received positive feedback from health care providers following the recent launch of KEYNOTE-A39 in advanced urothelial cancer. With this approval, KEYTRUDA in combination with PADCEV is now indicated for first-line advanced urothelial cancer patients, regardless of cisplatin eligibility. Based on the outstanding clinical data, we believe this regimen has the potential to transform the standard of care for these patients.

在最近推出治療晚期尿路上皮癌的 KEYNOTE-A39 後，我們也收到了醫療保健提供者的正面回饋。憑藉這項批准，KEYTRUDA 與 PADCEV 聯合治療現在適用於第一線晚期尿路上皮癌患者，無論順鉑是否符合資格。基於出色的臨床數據，我們相信該方案有可能改變這些患者的護理標準。

Alliance revenue from Lynparza and Lenvima grew 8% and 5%, respectively. WELIREG sales grew 78% to $72 million driven by increased uptake in VHL-associated tumors. We are excited by the opportunity to provide a new treatment option for certain patients with previously treated advanced renal cell carcinoma, following the recent approval based on the LITESPARK-005 study.

Lynparza 和 Lenvima 的聯盟收入分別成長 8% 和 5%。由於 VHL 相關腫瘤的吸收增加，WELIREG 銷售額成長了 78%，達到 7,200 萬美元。繼最近基於 LITESPARK-005 研究獲得批准後，我們很高興有機會為某些先前接受過治療的晚期腎細胞癌患者提供新的治療選擇。

Our Vaccines portfolio delivered excellent growth led by GARDASIL, which increased 27% to $1.9 billion, driven by global demand, particularly in China. In the U.S., GARDASIL sales benefited from CDC purchasing patterns.

我們的疫苗產品組合在 GARDASIL 的帶動下實現了出色的成長，在全球需求（尤其是中國的需求）的推動下，成長了 27%，達到 19 億美元。在美國，GARDASIL 的銷售受益於 CDC 的採購模式。

VAXNEUVANCE sales grew to $176 million driven by ongoing launches in Europe and continued uptake of the pediatric indication in the U.S. As a reminder, fourth quarter 2022 sales in the U.S. benefited from inventory stocking in preparation for the pediatric launch.

在歐洲持續上市以及美國兒科適應症持續普及的推動下，VAXNEUVANCE 銷售額增長至 1.76 億美元。需要提醒的是，美國 2022 年第四季度的銷售額受益於為兒科上市做準備的庫存儲備。

In our hospital acute care portfolio, BRIDION sales declined 3%. Increased market share among neuromuscular blockade reversal agents in the U.S. was more than offset by the impact of generic entrants in international markets, particularly in Europe.

在我們的醫院急診護理產品組合中，BRIDION 銷售額下降了 3%。美國神經肌肉阻斷逆轉劑市場份額的增加被國際市場（尤其是歐洲）仿製藥進入者的影響所抵消。

Our Animal Health business delivered another solid quarter with sales increasing 4%. Companion animal sales grew 12% driven by the BRAVECTO line of product due to strong underlying demand and timing of purchases. Livestock sales were flat, reflecting favorable price actions, offset by the timing of ruminant product purchases.

我們的動物保健業務在本季再次表現強勁，銷售額成長了 4%。由於強勁的潛在需求和購買時機，在 BRAVECTO 產品線的推動下，伴侶動物銷售額成長了 12%。牲畜銷售持平，反映出有利的價格趨勢，但被反芻動物產品購買時間所抵銷。

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 77.2%, an increase of 1.5 percentage points, largely due to favorable product mix, including a benefit from lower sales of LAGEVRIO. Operating expenses increased to $11.6 billion, including a $5.5 billion onetime charge related to our collaboration with Daiichi Sankyo. Excluding this charge, operating expenses grew 8%, reflecting disciplined investment in support of our expansive early- and late-phase pipeline and key growth drivers. Other expense was $174 million.

現在我將向您介紹我們損益表的其餘部分，我的評論將基於非公認會計原則。毛利率為77.2%，成長1.5個百分點，主要得益於有利的產品組合，包括受益於LAGEVRIO銷售下降。營運支出增加至 116 億美元，其中包括與第一三共合作相關的 55 億美元一次性費用。扣除此項費用後，營運費用增加了 8%，反映出為支持我們廣泛的早期和後期產品線以及關鍵成長動力而進行的嚴格投資。其他費用為 1.74 億美元。

Our tax rate was approximately 114%, which reflects the impact of the charge related to Daiichi Sankyo. Excluding this charge, the underlying tax rate was 13.1%. Taken together, earnings per share were $0.03, which includes a $1.69 negative impact from the charge related to Daiichi Sankyo.

我們的稅率約為 114%，反映了第一三共相關費用的影響。扣除此項費用後，基本稅率為 13.1%。總計每股收益為 0.03 美元，其中包括第一三共相關指控帶來的 1.69 美元負面影響。

Now turning to our 2024 non-GAAP guidance. We expect another year of strong growth driven by key marketed products, and we'll begin to benefit from the anticipated launches of impactful new products, such as sotatercept and V116. We project revenue to be between $62.7 billion and $64.2 billion, representing growth of 4% to 7%. This growth includes a negative impact from foreign exchange of approximately 2% using mid-January rates. The headwind is primarily due to the devaluation of the Argentine peso, which we expect will largely be offset by inflation-related price increases, consistent with market practice.

現在轉向我們的 2024 年非 GAAP 指引。我們預計，在關鍵上市產品的推動下，又將迎來強勁成長的一年，我們將開始受益於預計推出的有影響力的新產品，如 sotatercept 和 V116。我們預計營收將在 627 億美元至 642 億美元之間，成長 4% 至 7%。以 1 月中旬匯率計算，這一增長包括約 2% 的外匯負面影響。不利因素主要是由於阿根廷比索貶值，我們預期阿根廷比索貶值將在很大程度上被通膨相關的價格上漲所抵消，這與市場慣例一致。

Our gross margin assumption is approximately 80.5%, which includes the benefit from reduced royalties paid on KEYTRUDA and GARDASIL. Operating expenses are assumed to be between $25.1 billion and $26.1 billion, which includes an approximate $650 million onetime charge related to the announced acquisition of Harpoon Therapeutics. As a reminder, our guidance does not assume additional significant potential business development transactions.

我們的毛利率假設約為 80.5%，其中包括 KEYTRUDA 和 GARDASIL 支付的特許權使用費減少帶來的收益。營運費用預計在 251 億美元至 261 億美元之間，其中包括與宣布收購 Harpoon Therapeutics 相關的約 6.5 億美元一次性費用。提醒一下，我們的指導意見並未假設額外的重大潛在業務發展交易。

Other expense is expected to be approximately $200 million. We assume a full-year tax rate between 14.5% and 15.5%. We assume approximately 2.54 billion shares outstanding. Taken together, we expect EPS of $8.44 to $8.59. This range includes an approximate $0.26 per share charge related to the planned acquisition of Harpoon Therapeutics, which is not tax-deductible, and the negative impact from foreign exchange of approximately $0.25 using mid-January rates, including the impact from Argentina.

其他費用預計約2億美元。我們假設全年稅率在 14.5% 至 15.5% 之間。我們假設流通股約為 25.4 億股。綜合來看，我們預計每股收益為 8.44 美元至 8.59 美元。這一範圍包括與計劃收購 Harpoon Therapeutics 相關的每股約 0.26 美元的費用，該費用不可免稅，以及以 1 月中旬匯率計算約 0.25 美元的外匯負面影響，包括來自阿根廷的影響。

Now turning to capital allocation, where our strategy remains unchanged. We will prioritize investments in our business to drive near- and long-term growth. We are excited by the significant progress our team has made to advance and augment our innovative pipeline in 2023. In 2024, we will increase this investment, including the initiation of more late-stage clinical trials across multiple novel candidates, each of which has significant potential to address important unmet medical needs.

現在轉向資本配置，我們的策略保持不變。我們將優先投資於我們的業務，以推動近期和長期成長。我們對我們的團隊在2023 年推進和擴大我們的創新管道方面取得的重大進展感到興奮。到2024 年，我們將增加這項投資，包括針對多個新候選藥物啟動更多後期臨床試驗，每個候選藥物都具有重大意義解決重要的未滿足的醫療需求的潛力。

We remain committed to our dividend and plan to increase it over time. Business development remains a high priority. We maintain ample capacity given our strong investment-grade credit rating and cash flow to pursue additional science-driven, value-enhancing transactions going forward. We will continue to execute a modest level of share repurchases.

我們仍然致力於支付股息，並計劃隨著時間的推移增加股息。業務發展仍然是重中之重。鑑於我們強大的投資等級信用評級和現金流，我們保持充足的能力來追求未來更多的科學驅動、增值交易。我們將繼續進行適度的股票回購。

To conclude, we enter 2024 with confidence in the outlook for our business in the near and long term. Global demand for our innovative medicines and vaccines remain strong, and we are excited about our expansive pipeline. We are in a position of financial and operational strength as a direct result of our long-standing commitment to science in order to improve the lives of the patients we serve. Our continued investments in innovation and excellent execution will enable us to deliver value to patients, customers and shareholders well into the future.

總而言之，進入 2024 年，我們對我們的近期和長期業務前景充滿信心。全球對我們的創新藥物和疫苗的需求仍然強勁，我們對我們廣泛的產品線感到興奮。我們之所以擁有如此強大的財務和營運實力，是因為我們長期致力於科學，以改善我們所服務的患者的生活。我們對創新和卓越執行的持續投資將使我們能夠在未來為患者、客戶和股東創造價值。

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

有了這個，我現在想把電話轉給迪恩。

Thank you, Caroline. Good morning. Today, I will provide notable R&D updates since our last earnings call and a brief summary of 2023 accomplishments. Momentum in the pipeline remains strong. Progress is spanning both early- and late-phase programs across multiple therapeutic areas.

謝謝你，卡洛琳。早安.今天，我將提供自上次財報電話會議以來的重要研發動態，以及 2023 年成就的簡要總結。管道中的勢頭仍然強勁。多個治療領域的早期和後期項目都取得了進展。

Starting with oncology. We are diversifying our portfolio and executing on our strategy, which is broadly based on 3 strategic pillars: immuno-oncology; precision molecular targeting; and tissue targeting. In immuno-oncology, we remain committed to the development of KEYTRUDA and further transforming cancer care to address the needs of certain patients. In the fourth quarter, we received approvals from both the FDA and the European Commission in 2 gastrointestinal indications: one in combination with chemotherapy for the first-line treatment of adults with locally-advanced unresectable or metastatic HER2-negative gastric or gastroesaphageal junction adenocarcinoma based on KEYNOTE-A59; and another in combination with gemcitabine and cisplatin for the treatment of patients with locally-advanced unresectable or metastatic biliary tract cancer based on KEYNOTE-966.

從腫瘤學開始。我們正在使我們的產品組合多樣化並執行我們的策略，該策略大致基於三個策略支柱：免疫腫瘤學；精準分子標靶；和組織標靶。在免疫腫瘤學領域，我們仍然致力於 KEYTRUDA 的開發，並進一步改變癌症治療以滿足某些患者的需求。第四季度，我們獲得了FDA 和歐盟委員會對2 個胃腸道適應症的批准：一個是與化療聯合用於一線治療患有局部晚期不可切除或轉移性HER2 陰性胃或胃食道交界腺癌的成人患者。關於 KEYNOTE-A59；另一種則是基於KEYNOTE-966，合併吉西他濱和順鉑治療局部晚期不可切除或轉移性膽道癌患者。

As we continue to harness the potential of KEYTRUDA, we have an increased focus on earlier stages of disease, where we believe timely, effective intervention may significantly improve patient outcomes. Last month, we announced FDA approval for KEYTRUDA in combination with chemo radiotherapy for the treatment of FIGO Stage III through IVa cervical cancer based on the Phase III KEYNOTE-A18 trial. This is an important advancement and provides a new option that has potential to become the standard of care.

隨著我們繼續利用 KEYTRUDA 的潛力，我們越來越關注疾病的早期階段，我們相信及時、有效的干預可以顯著改善患者的治療結果。上個月，我們宣布 FDA 根據 III 期 KEYNOTE-A18 試驗批准 KEYTRUDA 聯合化療放療用於治療 Figo III 期至 IVa 期子宮頸癌。這是一項重要的進步，提供了一種有可能成為護理標準的新選擇。

To date, with all the research conducted with checkpoint inhibitors, the only studies to have demonstrated statistically significant overall survival benefit in earlier-stage cancers are KEYTRUDA-based regimens: KEYNOTE-671 as part of a neoadjuvant followed by post-surgery adjuvant treatment regimen for certain patients with resectable non-small cell lung cancer and KEYNOTE-564 as a post-surgery adjuvant treatment regimen for certain patients with renal cell carcinoma.

迄今為止，在所有使用檢查點抑制劑進行的研究中，唯一證明早期癌症具有統計意義的總體生存獲益的研究是基於KEYTRUDA 的治療方案：KEYNOTE-671 作為新輔助治療的一部分，隨後採用術後輔助治療方案對於某些可切除的非小細胞肺癌患者，KEYNOTE-564 作為某些腎細胞癌患者的術後輔助治療方案。

Since the approval of a KEYNOTE-671 in October, it is notable that the American Cancer Society released guidance recommending that certain individuals with significant smoking history undergo an annual low-dose CT scan. The guidance also expands the age range for lung cancer screening. We look forward to the opportunity to help impact patients and support the identification of more patients at risk.

自 10 月 KEYNOTE-671 獲得批准以來，值得注意的是，美國癌症協會發布了指南，建議某些有明顯吸煙史的個體每年接受一次低劑量 CT 掃描。該指南還擴大了肺癌篩檢的年齡範圍。我們期待有機會幫助影響患者並支持識別更多處於危險中的患者。

Additional data from KEYNOTE-564 demonstrating an overall survival benefit were presented at the ASCO GU conference last week. Detailed findings from KEYNOTE-123 evaluating KEYTRUDA for the adjuvant treatment of patients with localized, muscle-invasive and locally-advanced resectable urothelial carcinoma demonstrating a disease-free survival benefit versus observation were also presented at ASCO GU.

上週在 ASCO GU 會議上公佈了來自 KEYNOTE-564 的更多數據，證明了整體生存獲益。 KEYNOTE-123 評估 KEYTRUDA 對局部、肌肉侵襲性和局部晚期可切除尿路上皮癌患者的輔助治療的詳細結果也在 ASCO GU 上發表，該結果表明與觀察相比，無病生存獲益。

Also in the earlier-stage setting, along with our partner, Moderna, we announced 3-year recurrent-free survival and distant metastasis-free survival data for our individualized neoantigen therapy, V940, in combination with KEYTRUDA for the adjuvant treatment of Stage III and IV melanoma following complete resection. We are encouraged by the durability of the responses observed and the potential for this regimen to impact patients earlier in their diagnosis. The Phase III trials in the adjuvant setting for certain patients with melanoma and non-small cell lung cancer are actively enrolling.

同樣在早期階段，我們與我們的合作夥伴 Moderna 一起公佈了我們的個人化新抗原療法 V940 與 KEYTRUDA 聯合用於 III 期輔助治療的 3 年無復發生存率和無遠處轉移生存率數據和完全切除後的IV 黑色素瘤。我們對觀察到的反應的持久性以及該方案對患者早期診斷產生影響的潛力感到鼓舞。針對某些黑色素瘤和非小細胞肺癌患者的輔助治療的 III 期試驗正在積極招募。

Progress continues in precision oncology. The FDA approval for WELIREG, our HIF2 alpha inhibitor for the treatment of adults with advanced RCC following a PD-1 or PD-L1 inhibitor and a VEGF-TKI, marks the first drug approved in a new therapeutic class for eligible patients with advanced renal cell carcinoma in nearly a decade and builds on the 2021 approval for the treatment of adults with certain von Hippel-Lindau disease-associated tumors. Additional Phase III studies for WELIREG, in combination with KEYTRUDA and/or lenvatinib for the treatment of certain types of renal cell carcinoma in the advanced and adjuvant settings, are ongoing.

精準腫瘤學不斷取得進展。 FDA 批准WELIREG 是我們的HIF2 α 抑制劑，用於治療接受PD-1 或​​ PD-L1 抑制劑和VEGF-TKI 治療的成人晚期腎細胞癌，這標誌著第一個新治療類別中批准的藥物，適用於符合條件的晚期腎細胞癌患者近十年來對細胞癌的治療，並建立在 2021 年批准用於治療患有某些 von Hippel-Lindau 病相關腫瘤的成人的基礎上。 WELIREG 與 KEYTRUDA 和/或樂伐替尼聯合治療某些類型腎細胞癌的晚期和輔助治療的其他 III 期研究正在進行中。

Finally, moving to the tissue targeting space. Together with Astellas and Seagen, now Pfizer, we announced the FDA approval for KEYTRUDA in combination with PADCEV, a Nectin-4-targeting ADC for the first-line treatment to patients with locally advanced or metastatic urothelial cancer based on results from KEYNOTE-A39. These results demonstrated a superior overall survival benefit versus gemcitabine plus cisplatin or carboplatin and extend our pioneering work in combining KEYTRUDA with chemotherapy as well as reinforcing the value of an ADC to enable targeted delivery of chemotherapy to the tumor tissue.

最後，移動到組織標靶空間。根據KEYNOTE-A39 的結果，我們與Astellas 和Seagen（現為輝瑞）一起宣布FDA 批准KEYTRUDA 與PADCEV 聯合使用，PADCEV 是一種Nectin-4 靶向ADC，用於局部晚期或轉移性尿路上皮膚癌患者的一線治療。這些結果表明，與吉西他濱加順鉑或卡鉑相比，具有更優越的整體生存獲益，並擴展了我們將KEYTRUDA 與化療相結合的開創性工作，並增強了ADC 的價值，使化療能夠靶向遞送至腫瘤組織。

Following the announcement of our collaboration with Daiichi Sankyo in October, we are pleased to receive priority review from the FDA for MK-1022, or patritumab deruxtecan, our investigation of a fully humanized anti-HER3 ADC for patients with advanced EGFR-mutated non-small cell lung cancer previously treated with 2 or more systemic therapies. The agency has set a target action date of June 26.

繼10 月宣布與第一三共(Daiichi Sankyo) 合作後，我們很高興收到FDA 對MK-1022 或patritumab deruxtecan 的優先審查，這是我們對一種完全人源化抗HER3 ADC 的研究，用於治療晚期EGFR 突變的非晚期患者。先前接受過 2 種或多種全身療法治療的小細胞肺癌。該機構已將目標行動日期定為 6 月 26 日。

Through our agreements with Kelun and Daiichi Sankyo as well as our own discovery programs, we have established a robust pipeline of tissue-targeting ADCs. And the recently announced acquisition of Harpoon Therapeutics provides the opportunity to help complement and strengthen our approach by providing a portfolio of novel T cell engagers, the most significant of which is HPN-328, an investigational delta-like ligand 3 targeting T cell engager being evaluated in small cell lung cancer and neuroendocrine tumors.

透過我們與 Kelun 和 Daiichi Sankyo 的協議以及我們自己的發現計劃，我們建立了強大的組織來靶向 ADC 管道。最近宣布收購Harpoon Therapeutics 提供了機會，透過提供一系列新型T 細胞接合劑來幫助補充和加強我們的方法，其中最重要的是HPN-328，這是一種針對T 細胞接合劑的研究性delta 樣配體 3在小細胞肺癌和神經內分泌腫瘤中進行了評估。

Our strong diverse portfolio of immuno-oncology precision molecular and tissue-targeting agents positions us well to have a profound impact on even more patients long into the future.

我們強大的多樣化免疫腫瘤學精準分子和組織標靶藥物組合使我們能夠在未來對更多患者產生深遠影響。

Next to our Vaccine pipeline. We are making notable advancements with our population-specific vaccine program for pneumococcal disease. The FDA has accepted for priority review the new biologics license application for V116, our 21-valent pneumococcal conjugate vaccine, specifically designed for adults supported by results from multiple Phase III clinical trials evaluating V116 in both pneumococcal vaccine-naive and vaccine-experienced adult patient population.

在我們的疫苗管道旁邊。我們的針對特定族群的肺炎鏈球菌疾病疫苗計畫正在取得顯著進展。 FDA 已接受優先審查V116 的新生物製劑許可申請，​​V116 是我們的21 價肺炎球菌結合疫苗，專為成人設計，並得到多項III 期臨床試驗結果的支持，這些試驗在未接種過肺炎球菌疫苗和接種過疫苗的成年患者中評估了V116人口。

Results from STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November and additional data from STRIDE-3 as well as STRIDE studies 4, 5 and 6 will be presented at the International Society of Pneumonia and Pneumococcal Disease Congress in March.

STRIDE-3 試驗的結果已於 11 月在西海岸世界疫苗大會上公佈，STRIDE-3 以及 STRIDE 研究 4、5 和 6 的其他數據將於 3 月在國際肺炎和肺炎球菌疾病協會大會上公佈。

If approved, as Rob noted, V116 would be the first new pneumococcal-conjugate vaccine specifically designed to address the serotypes responsible for approximately 83% of invasive pneumococcal disease in adults 65 years of age and older, according to CDC data from 2018 to 2021. Importantly, V116 includes 8 unique serotypes, which account for 30% of disease according to the same CDC data. These serotypes are not covered by currently licensed pneumococcal vaccine options. The FDA has set a target action date of June 17.

正如Rob 指出的那樣，如果獲得批准，V116 將成為第一種新型肺炎球菌結合疫苗，根據CDC 2018 年至2021 年的數據，專門針對導致65 歲及以上成人約83% 侵襲性肺炎球菌疾病的血清型。重要的是，V116 包括 8 種獨特的血清型，根據相同的 CDC 數據，這些血清型佔疾病的 30%。目前獲得許可的肺炎球菌疫苗選項不涵蓋這些血清型。 FDA 已將目標行動日期定為 6 月 17 日。

Turning to programs in the cardiometabolic disease pipeline. We are eager to bring sotatercept to patients as an important treatment option for pulmonary arterial hypertension. The FDA has set a target action date of March 26.

轉向心臟代謝疾病管道中的項目。我們渴望將 sotatercept 作為肺動脈高壓的重要治療選擇帶給患者。 FDA 已將目標行動日期定為 3 月 26 日。

Beyond data from the STELLAR trial, we have the Phase III ZENITH and HYPERION studies, which are evaluating sotatercept in patients with more advanced disease and those earlier on their disease journey. In addition, the Phase II CADENCE trial will evaluate WHO Group II pulmonary hypertension focused on a type of left heart disease.

除了 STELLAR 試驗的數據外，我們還有 III 期 ZENITH 和 HYPERION 研究，這些研究正在評估 sotatercept 對晚期疾病患者和早期疾病患者的作用。此外，第二階段 CADENCE 試驗將評估 WHO II 組肺動脈高壓，並專注於一種左心疾病。

As we close out 2023, it is important to highlight our significant progress and execution across therapeutic areas and modalities as well as multiple business development transactions. In the year, we have more than 25 regulatory approvals in major markets. We also initiated over 20 Phase III studies across multiple new classes of assets, including in oncology with bomedemstat, our LSD1 inhibitor in essential thrombocythemia; nemtabrutinib, our BTK inhibitor in first-line chronic lymphocytic leukemia or small lymphocytic lymphoma; MK-2870, our TROP2 ADC in collaboration with Kelun in non-small cell lung cancer and endometrial carcinoma; MK-5284, our CYP11A1 inhibitor in collaboration with Orion in metastatic castrate-resistant prostate cancer; and V940 in collaboration with Moderna for the adjuvant treatment of certain types of melanoma and non-small cell lung cancer.

在 2023 年即將結束之際，重要的是要強調我們在治療領域和模式以及多項業務發展交易方面的重大進展和執行情況。今年，我們在主要市場獲得了超過 25 個監管批准。我們也針對多種新資產啟動了 20 多項 III 期研究，包括在腫瘤學中使用 bomedemstat（我們的 LSD1 抑制劑治療原發性血小板增多症）； nemtabrutinib，我們用於治療第一線慢性淋巴球白血病或小淋巴球淋巴瘤的 BTK 抑制劑； MK-2870，我們與科倫合作的TROP2 ADC，用於非小細胞肺癌和子宮內膜癌； MK-5284，我們的 CYP11A1 抑制劑，與 Orion 合作治療轉移性去勢抗性前列腺癌； V940與Moderna合作用於某些類型黑色素瘤和非小細胞肺癌的輔助治療。

Also in immunology, with tulisokibart in ulcerative colitis. Finally, in cardiometabolic disease with multiple trials for MK-0616 in hypercholesterolemia.

在免疫學方面，圖利索巴特（tulisokibart）用於治療潰瘍性結腸炎。最後，在心臟代謝疾病方面，針對 MK-0616 治療高膽固醇血症進行了多項試驗。

As a result of the increasing depth and breadth of our pipeline, we are planning to initiate an even greater number of Phase III trials in 2024. Considerable credit goes to my colleagues across the organization for their hard work and unwavering dedication. We are executing on our science-led strategy and look forward to providing further updates on our progress throughout the year.

由於我們的產品線深度和廣度不斷增加，我們計劃在 2024 年啟動更多的 III 期試驗。整個組織的同事們的辛勤工作和堅定不移的奉獻精神值得高度讚揚。我們正在執行以科學為主導的策略，並期待提供全年進展的進一步更新。

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. Ivy, we're now ready to take questions. (Operator Instructions) Thank you.

謝謝你，迪恩。艾維，我們現在準備好回答問題了。 （操作員說明）謝謝。

(Operator Instructions)

（操作員說明）

Our first question will come from the line of Umer Raffat from Evercore ISI.

我們的第一個問題來自 Evercore ISI 的 Umer Raffat。

I know there's a trial due for you guys later this year, KEYFORM-007 trial. That's the LAG-3 with pembrolizumab in colorectal cancer. Just curious how you're thinking about the risk profile and the odds of success heading into that and if there's been any interim OS analysis.

我知道今年稍後你們將進行一次試驗，即 KEYFORM-007 試驗。這就是 LAG-3 與 pembrolizumab 合併治療大腸直腸癌。只是好奇您如何考慮風險狀況和成功的可能性，以及是否有任何中期作業系統分析。

I'll take this. Umer, thank you very much for that question. I mean just to recognize that in MSI high, we have a strong presence with pembro there. The larger group in CRC or colorectal cancer is in the MSS population. At this point, there's not really been any checkpoint inhibitor that's shown dramatic impact in MSS CRC. So our interest in driving pembro plus LAG-3 in that is to demonstrate that a checkpoint inhibitor could have a meaningful impact in MSS CRC.

我要這個。烏默，非常感謝你提出這個問題。我的意思是要認識到，在 MSI 高中，我們的 pembro 在那裡有很強的影響力。 CRC 或大腸直腸癌中較大的族群是 MSS 族群。目前，還沒有任何檢查點抑制劑對 MSS CRC 產生顯著影響。因此，我們對推動 pembro 加 LAG-3 的興趣在於證明檢查點抑制劑可以對 MSS CRC 產生有意義的影響。

If we should get a positive signal in that, clearly, we would use that as a beachhead to expand and extend the role of checkpoint inhibitors in MSS CRC, which is a place that requires a lot of more innovation. In terms of specific interim analysis on this, we generally try to keep that when there's data that's worth sharing, that's when we share it.

如果我們在這方面得到正面訊號，顯然我們會以此為灘頭陣地來擴大和延伸檢查點抑制劑在 MSS CRC 中的作用，這是一個需要更多創新的地方。就具體的中期分析而言，我們通常會盡量保留當有值得分享的資料時，我們就會分享它。

Next, we'll go to the line of Trung Huynh from UBS.

接下來，我們將前往 UBS 的 Trung Huynh 線路。

So for sotatercept, we noticed the HYPERION study primary completion date has now moved to August 26. It was November 29 on clinicaltrials.gov. That's 3 years earlier. Just -- could you just let us know the reason for that change? And if I could sneak one in. Just is there a place to transition sotatercept from inpatient clinic administration to self-administration?

因此，對於 sotatercept，我們注意到 HYPERION 研究的初步完成日期現已移至 8 月 26 日。在 ClinicalTrials.gov 上顯示的日期是 11 月 29 日。那是3年前的事了。只是—您能否讓我們知道這項變化的原因？如果我能偷偷溜進去的話。是否有地方可以將 sotatercept 從住院診所管理過渡到自我管理？

So let me take the first question. So there's a series of trials in relationships with sotatercept. So the March date that we talk about is for a potential decision by the FDA for approval based on the STELLAR trial. And we think in the second half of 2024, we may be in a position in relationship to the EU.

那麼讓我來回答第一個問題。因此，針對與 sotatercept 的關係進行了一系列試驗。因此，我們討論的 3 月日期是 FDA 根據 STELLAR 試驗做出批准決定的潛在日期。我們認為，到 2024 年下半年，我們可能會在與歐盟的關係中處於有利地位。

We have other trials, as you point out, especially Phase III trials, and they are ZENITH and they are HYPERION. Those 2 are based on events. So it's a tracking of events that sort of define when those happen. So the ZENITH, I think, is now like September 2025 and HYPERION is August 2026. So that's just been event-driven.

正如您所指出的，我們還有其他試驗，特別是 III 期試驗，它們是 ZENITH 和 HYPERION。這兩個是基於事件的。因此，它是對事件的跟踪，可以定義這些事件何時發生。所以我認為 ZENITH 現在是 2025 年 9 月，HYPERION 是 2026 年 8 月。所以這只是事件驅動的。

In relationship to how best to treat patients, well we're in conversations with the FDA in relationship to where is the best place for patients to be treated. But I'll just highlight that we have an image of an auto injector moving very fast through our pipeline. So that might give you a sense of where we think this may end up.

關於如何最好地治療患者，我們正在與 FDA 就哪裡是患者接受治療的最佳地點進行對話。但我只想強調一下，我們有一張自動注射器在管道中快速移動的圖像。這可能會讓您了解我們認為這可能會導致什麼結果。

Next, we'll go to the line of Daina Graybosch from Leerink Partners.

接下來，我們將介紹 Leerink Partners 的 Daina Graybosch 系列。

One on Oncology for one of the new assets going into Phase III, the ORION MK-5684. I wonder if you could talk more about that asset. And what gives you confidence that it will demonstrate broad benefit in prostate cancer, in addition to the patients with the ARLBD mutations? And can you confirm the stat design of the 2 Omaha studies will prioritize a hierarchy to statistically look at the mutation segment first?

一項關於腫瘤學的研究，涉及進入第三階段的新資產之一，ORION MK-5684。我想知道您是否可以更多地談論該資產。除了對具有 ARLBD 突變的患者之外，是什麼讓您相信它還將在前列腺癌中顯示出廣泛的益處？您能否確認兩個奧馬哈研究的統計設計將優先考慮一個層次結構，首先對突變片段進行統計分析？

Yes. So just so that everyone is looking at this asset in the same way, there have been critical medicines that ablate androgen field growth in prostate cancer. And the interest in the CYP11A1 is it's very high upstream, and we think that it could be an important contribution.

是的。因此，為了讓每個人都以同樣的方式看待這項資產，已經有一些關鍵藥物可以消除前列腺癌中雄性激素區域的生長。人們對 CYP11A1 的興趣在於它的上游非常高，我們認為它可能是一個重要的貢獻。

Clearly, we're in -- as you point out, we're interested both broadly, but especially in the specific mutation patients. And so we will be advancing those trials to look at that subpopulation as well as more broad populations. In terms of the statistical sort of analysis in that, that's something that I think probably would be best sort of discussed with our clinical teams at a different time.

顯然，正如您所指出的，我們對兩者都廣泛感興趣，但特別是對特定突變患者。因此，我們將推進這些試驗，以研究該亞人群以及更廣泛的人群。就統計分析而言，我認為最好在不同時間與我們的臨床團隊進行討論。

Next, we'll go to Carter Gould from Barclays.

接下來，我們請來巴克萊銀行的卡特·古爾德。

Maybe following up on the commentary on V116. You talked about a potential to reach a majority market share. What does that sort of imply around the potential ACIP recommendation or the potential for a catch-up opportunity in the adult segment?

也許會跟進V116的評論。您談到了獲得多數市場份額的潛力。這對於潛在的 ACIP 建議或成人市場的追趕機會意味著什麼？

Yes. So I'll just -- so again, we're talking about V116. We're talking about FDA potential action in June 2024, followed by ACIP, followed by MMWR. I think it's in March that we're going to be presenting STRIDE-3 and 6, and I think the data will be out there. And as you'll see in that, between STRIDE-3 and throughout STRIDE-3 all the way to 6, you'll see data in relationship to vaccination of those who are naive versus previously vaccinated. And you will see data in the patient population, or the population that 65, but also in the 50-plus as well. As that data is digested, both by the FDA, but probably very importantly, by the ACIP, I think those data will guide how the ACIP makes their decision.

是的。所以我會再次強調，我們談論的是 V116。我們正在討論 FDA 於 2024 年 6 月採取的潛在行動，隨後是 ACIP，隨後是 MMWR。我認為我們將在三月展示 STRIDE-3 和 6，並且我認為數據將會公佈。正如您將看到的那樣，在 STRIDE-3 之間以及整個 STRIDE-3 一直到 6，您將看到與未接種疫苗的人與之前接種過疫苗的人的疫苗接種相關的數據。您將看到患者人群、65 歲以上人群以及 50 歲以上人群的數據。由於 FDA 以及 ACIP 都對這些數據進行了消化，我認為這些數據將指導 ACIP 如何做出決定。

Next, we'll go to the line of Evan Seigerman from BMO Capital Markets.

接下來，我們將邀請 BMO 資本市場的 Evan Seigerman。

I was wondering if you could expand on some of the nuances of your guidance. Specifically, do you include meaningful revenues from sotatercept or V116? I'm assuming they're due for approval at some point this year.

我想知道您是否可以詳細闡述您的指導中的一些細微差別。具體來說，您是否包括來自 sotatercept 或 V116 的有意義的收入？我假設它們將在今年某個時候獲得批准。

Thank you for the question, Evan. This is Caroline. As we've guided for 2024, we're very confident in the underlying momentum in our business across Oncology, across Vaccines, across Animal Health. We also are very excited about the potential launches for sotatercept and V116.

謝謝你的提問，埃文。這是卡羅琳。正如我們對 2024 年的指導，我們對腫瘤學、疫苗和動物保健業務的潛在勢頭非常有信心。我們也對 sotatercept 和 V116 的潛在上市感到非常興奮。

For sotatercept, given the significant clinical data we have and the understanding that there are many patients that have already been identified who can benefit for sotetecept on top of the treatments they have, we are expecting a strong launch. For V116, as Dean just outlined, we'll wait for the FDA approval, the ACIP recommendation. We'll then expect MMWR to publish, and therefore, expect to have impact with V116 coming towards the end of this year.

對於 sotatercept，鑑於我們擁有重要的臨床數據，並且了解已經確定許多患者除了接受治療外還可以從 sotetecept 中受益，我們預計會強勢​​推出。對於 V116，正如 Dean 剛才所概述的那樣，我們將等待 FDA 的批准，即 ACIP 的建議。然後，我們預計 MMWR 將發布，因此預計會對今年年底的 V116 產生影響。

Next, we'll go to the line of Terence Flynn from Morgan Stanley.

接下來，我們將轉到摩根士丹利的特倫斯·弗林（Terence Flynn）。

A competitor recently reported some disappointing data with their TROP2 ADC and later line lung. I recognize these TROP2s are all different given the technology, the linkers. But does this impact at all your development strategy for your TROP2 in lung or perhaps increase the need for a biomarker strategy here?

一位競爭對手最近報告了他們的 TROP2 ADC 和後來的線肺的一些令人失望的數據。我認識到這些 TROP2 在技術和連接器方面都是不同的。但這是否會影響您在肺部的 TROP2 開發策略，或者可能會增加對生物標記策略的需求？

Yes. This is Dean. Thanks for that question. So I'll just step back, and I think I've said this previously, especially in lung, it's very important to understand what the standard of care is and that one would have to beat it in a significant way. And the standard of care, in our minds, in the late stage, is roughly KEYNOTE-189. And now in the earlier stage, it's clearly in KEYNOTE-671 both with clear OS data.

是的。這是迪恩。謝謝你提出這個問題。所以我退後一步，我想我之前已經說過了，尤其是在肺部，了解護理標準是什麼非常重要，並且必須以一種重要的方式擊敗它。而後期的護理標準，在我們心目中，大致是KEYNOTE-189。現在在早期階段，KEYNOTE-671 中顯然都有明確的作業系統資料。

What we have said previously is that we are unclear that any one ADC can have as broad of an impact as KEYNOTE-189 or 671 and that in order for ADC to have a substantial advantage in those patient populations, one may need to focus on a biomarker-selected patient population. And so the data that we saw does not change our way of thinking. It's the way of thinking that we've discussed previously.

我們之前說過的是，我們不清楚是否有任何一種 ADC 能夠產生像 KEYNOTE-189 或 671 一樣廣泛的影響，並且為了使 ADC 在這些患者群體中具有實質性優勢，人們可能需要關註生物標誌物選擇的患者群體。所以我們看到的數據並沒有改變我們的思考方式。這是我們之前討論過的思考方式。

And I would just add that it's really important, there's also data out there where people are doing retrospective biomarker data in this. For us to demonstrate true efficacy in any patient population, we need a biomarker strategy that is prospective and one that can be easily actionable throughout the world.

我想補充一點，這點非常重要，還有人們正在做回顧性生物標記數據的數據。為了在任何患者群體中證明真正的療效，我們需要一種具有前瞻性且可以在全世界範圍內輕鬆實施的生物標記策略。

Next, we'll go to the line of Tim Anderson from Wolfe Research.

接下來，我們將討論沃爾夫研究中心的 Tim Anderson 的路線。

This is Adam on for Tim. On GARDASIL, a 2-dose regimen was recently approved in China. We're wondering if that poses a revenue problem. Potentially, it doesn't, if it just means that more supply gets spread out across more people, and Merck ends up selling just as many doses in total. Can Merck share its perspective here?

這是亞當替提姆發言。 GARDASIL 的 2 劑治療方案最近在中國獲得批准。我們想知道這是否會帶來收入問題。如果這僅僅意味著更多的供應量分佈在更多的人身上，而默克公司最終銷售的劑量也同樣多，那麼可能不會。默克可以在這裡分享一下它的觀點嗎？

No, Adam, thanks for the question. So there's actually been Chinese competitors with an offering for some time actually in the Chinese market. And that market is large. We continue to believe in the eligible cohorts in just the urban females, which is the Tier 1 to Tier 3 cities, is about 200 million -- a little over 200 million women. And so of that, we think probably about 30% have actually received vaccination. So you're still looking at 120 million, 130 million eligible population.

不，亞當，謝謝你的提問。因此，實際上中國競爭對手在中國市場提供產品已經有一段時間了。而且這個市場很大。我們仍然相信，僅城市女性（即 1 至 3 線城市）中符合資格的人群就約有 2 億，略高於 2 億。因此，我們認為大約 30% 的人實際上已經接種了疫苗。所以你仍然關注 1.2 億、1.3 億符合條件的人口。

As we look at this and as we've seen over time, we continue to be very competitive. We're maintaining a vast majority of share in the private market. And really, you're seeing most of the local competitors go to the lower-tier cities and to a different population than we've been targeting. So that does not change our view of the growth potential in China long term. Obviously, we will continue to face competition there, and we are positioning ourselves to continue to succeed there. But the approval you're talking about is not changing our view.

從我們的角度來看，正如我們隨著時間的推移所看到的那樣，我們仍然非常有競爭力。我們在私人市場上保持著絕大多數份額。事實上，你會看到大多數本地競爭對手都進入了低線城市，並且進入了與我們目標不同的人群。因此，這不會改變我們對中國長期成長潛力的看法。顯然，我們將繼續在那裡面臨競爭，我們正在定位自己以繼續在那裡取得成功。但你所說的認可並沒有改變我們的觀點。

The only thing I add, if I may, is we have significant opportunity to protect further females in China. At the end of 2023, we also submitted to the regulatory authorities our data on GARDASIL for males. So we're hopeful to introduce that in the Chinese market in the future.

如果可以的話，我唯一補充的是，我們有很大的機會來保護更多中國女性。 2023 年底，我們也向監管機構提交了有關男性 GARDASIL 的數據。所以我們希望未來能將其引入中國市場。

Next, we'll go to the line of Mohit Bansal from Wells Fargo.

接下來，我們將前往富國銀行 (Wells Fargo) 的 Mohit Bansal 線路。

Congrats on the progress. Maybe one question on V116 as well. So Pfizer has recently made comments around adult market shrinking at this point. So could you comment on how do you see the peak opportunity for V116 in the context of adult market shrinking and then you're taking share from a shrinking market?

祝賀取得的進展。也許還有一個關於 V116 的問題。因此，輝瑞最近就成人市場萎縮發表了評論。那麼您能否評論一下，在成人市場萎縮的背景下，您如何看待 V116 的高峰機會，然後您又從萎縮的市場中奪取份額？

Yes. I'll start and then Caroline can jump in as well. But I think as you look at the market size and the comments, I don't want to speak to comments that others have made. I think it's also important to understand that as we bring a vaccine which brings significant incremental coverage, at 83% versus, if you look at PCV20, just as an example, it's closer to, I think, about 50%. So you're looking at significant incremental coverage, which I think can have an impact on how you think both about catch-up to cover the disease.

是的。我先開始，然後卡洛琳也可以加入。但我認為，當你看到市場規模和評論時，我不想談論其他人發表的評論。我認為了解這一點也很重要：當我們推出一種疫苗時，其覆蓋率將顯著提高，達到 83%，而以 PCV20 為例，我認為它更接近 50% 左右。因此，您正在考慮顯著增加的覆蓋範圍，我認為這可能會影響您對追趕疾病覆蓋範圍的看法。

As Dean noted in his prepared comments, we have 8 serotypes covering 30% of what is causing disease, which is unique to us. So we think that, that will have implications both in terms of catch-ups as well as potentially to be able to go for patients 50 and plus versus 65 and plus.

正如 Dean 在他準備好的評論中指出的那樣，我們有 8 种血清型，涵蓋了 30% 的致病因素，這是我們所獨有的。因此，我們認為，這不僅會對 50 歲及以上患者與 65 歲及以上患者的追趕產生影響。

So if you take all of those things into account, we still see this as a very large opportunity for us. Our view is it's about an $8 billion market in '23. We anticipate it actually growing to be over $10 billion later in the decade. And with that being the pediatric segment of that is about 70%. So we're looking at 30% of that is what is the adult piece. So as we see it, this is still a growing market, a good market. And we remain very confident that V116 will both have a majority share and be a meaningful contributor.

因此，如果考慮到所有這些因素，我們仍然認為這對我們來說是一個非常大的機會。我們的觀點是 23 年市場規模約為 80 億美元。我們預計在 20 世紀末這一數字實際上將增長到超過 100 億美元。其中兒科部分約佔 70%。所以我們關注的是成人作品的 30%。所以在我們看來，這仍然是一個不斷成長的市場，一個好的市場。我們仍然非常有信心 V116 將擁有多數份額並成為有意義的貢獻者。

Next, we'll go to the line of Chris Schott from JPMorgan.

接下來，我們將介紹來自摩根大通的克里斯·肖特 (Chris Schott)。

Just a bigger-picture question on business development. The company has obviously been very active the past few years. And I'm just trying to get a sense of just kind of size and stage of assets that you consider just given the current R&D investments you're making and the asset and kind of the amount of capital you're allocating there. So I guess, specifically, are deals along the lines of an Acceleron or a Prometheus still deals that Merck would look at and prioritize? Or at this point, should you be even thinking about maybe earlier-stage assets that would be more of the focus?

只是一個關於業務發展的宏觀問題。過去幾年，該公司顯然非常活躍。我只是想了解您考慮的資產規模和階段，考慮到您目前正在進行的研發投資以及您在那裡分配的資產和資本金額。所以我想，具體而言，默克是否仍會考慮並優先考慮與 Acceleron 或 Prometheus 類似的交易？或者在這一點上，您是否應該考慮可能更受關注的早期資產？

Yes. Chris, thanks for the question. Obviously, first, I just want to reinforce the pride I have in what Dean and the team have been able to do and the meaningful progress we're making both in our internal pipeline and what we've been able to do through the business development, which is, I think, in some ways, in a weird way, underlying your question.

是的。克里斯，謝謝你的提問。顯然，首先，我只是想強調我對 Dean 和團隊所做的事情以及我們在內部管道和業務發展中取得的有意義的進展感到自豪，我認為，在某些方面，以一種奇怪的方式，隱藏著你的問題。

As we sit here today, while I feel very good about the progress we've made in the growing portfolio, the diverse and deep portfolio we have in our pipeline, we do continue to believe we need more, and we will continue to prioritize business development. And I would say that our views of deals like Prometheus, like Acceleron are still the size of deals we are very interested in, if we can find great assets. So clearly, that's an area of focus. But also continuing to do smaller deals as well, like what you saw with Harpoon.

當我們今天坐在這裡時，雖然我對我們在不斷增長的投資組合、我們管道中擁有的多樣化和深入的投資組合方面取得的進展感到非常滿意，但我們仍然相信我們需要更多，我們將繼續優先考慮業務發展。我想說的是，如果我們能找到優質資產，我們對 Prometheus 和 Acceleron 等交易的看法仍然是我們非常感興趣的交易規模。顯然，這是一個重點領域。但也繼續做較小的交易，就像你在 Harpoon 看到的那樣。

So it's going to be a range of deals. But I think as you look in that 0 to kind of $15 billion, $1 billion to $15 billion, it continues to be where we will look for. And then obviously, we've also, I think, shown that not only are we very open to doing acquisition, but we see collaboration as an important tool as well, very similar to what we did with Daiichi Sankyo. So we're going to be looking at the full suite and including deals that fit those categories.

因此，這將是一系列交易。但我認為，當你觀察 0 到 150 億美元、10 億到 150 億美元時，它仍然是我們要尋找的地方。顯然，我認為我們也表明，我們不僅對收購非常開放，而且我們也將合作視為一個重要工具，這與我們對第一三共的做法非常相似。因此，我們將專注於全套產品，並包括適合這些類別的交易。

Next, we'll go to the line of Andrew Baum from Citi.

接下來，我們將請來花旗銀行的安德魯‧鮑姆 (Andrew Baum)。

I was going to ask you about your expectations for the ACIP recommendation on revaccination of Prevnar vaccinated patients, but I suspect you may not want to share that view. So instead, maybe I could ask you about the first-line TROP2 SKB non-small cell trials that you're running in combination with KEYTRUDA. Some of the recently published academic data suggests that TROP2 internalization is a biomarker in patients who are primarily resistant to PD-1.

我本來想問您對 ACIP 關於 Prevnar 疫苗接種患者重新接種疫苗的建議有何期望，但我懷疑您可能不想同意這一觀點。因此，也許我可以向您詢問有關您與 KEYTRUDA 聯合進行的一線 TROP2 SKB 非小細胞試驗的情況。最近發表的一些學術數據表明，TROP2 內化是對 PD-1 主要抗藥性的患者的生物標記。

So it just seems like an odd population to be exploring the drug in, assuming that is real and not a fake signal. And I take completely the caveats that it's retrospective data analysis in other settings. But given that, it would seem to be more sensible to have a combination with chemo and layering on top. And can you do this given the profile of the drug in terms of bone marrow suppression?

因此，假設這是真實的而不是虛假的信號，那麼探索這種藥物的人群似乎很奇怪。我完全接受警告，這是在其他環境中進行回顧性資料分析。但考慮到這一點，結合化療和分層似乎更明智。考慮到該藥物在骨髓抑制方面的特性，您能做到這一點嗎？

Yes. So I'll just answer more broadly in relationship to TROP2 as an ADC and specifically our compound. One of the things that is extremely useful to us is its adverse effect profile, especially for lung cancer patients and relationship to lung toxicity, is readily manageable. It's a quite good profile.

是的。因此，我將更廣泛地回答 TROP2 作為 ADC 的關係，特別是我們的化合物。對我們非常有用的事情之一是它的不良反應，特別是對於肺癌患者以及與肺毒性的關係，很容易控制。這是一個相當不錯的個人資料。

In terms of your question about the paper that I think that you talked about internalization and this, I think those are interesting and important papers for us to consider. But I think one of the things that's also important for us to do is to do the clinical experiment and see what the results are in relationship. We are confident that TROP2 ADC will have an impact. TROP2 ADCs in breast cancer has had an impact. And we believe that our TROP2 ADC, especially the linker payload, will have an important impact in lung cancer.

就您關於論文的問題而言，我認為您談到了內化和這一點，我認為這些論文是值得我們考慮的有趣且重要的論文。但我認為對我們來說同樣重要的事情之一是進行臨床實驗，看看結果之間的關係。我們相信 TROP2 ADC 將會產生影響。 TROP2 ADC 對乳癌產生了影響。我們相信我們的 TROP2 ADC，尤其是連接器有效負載，將對肺癌產生重要影響。

And then the question that you have is, how do you combine it? Do you combine it with chemo? Do you combine it with PD-1? How do you think through that? I think those are questions that our clinical team thinks deeply about, but we also think deeply about what line of therapy and also what the standard of care is. And if you want to move to first line standard of care is KEYNOTE-189 with a chemo/pembro basis. So one has to think about how one would advance a TROP2 from different lines all the way to first line. So those considerations come in quite heavily.

然後你的問題是，如何將它們結合起來？您將其與化療結合嗎？是否將其與 PD-1 結合使用？您對此有何看法？我認為這些是我們的臨床團隊深入思考的問題，但我們也深入思考了治療方案以及護理標準是什麼。如果您想轉移到第一線標準護理是基於化療/pembro 的 KEYNOTE-189。因此，人們必須考慮如何將 TROP2 從不同的生產線一直推進到第一條生產線。因此，這些考慮因素非常重要。

Next, we'll go to the line of Seamus Fernandez from Guggenheim Securities.

接下來，我們將邀請古根漢證券公司的謝默斯費南德茲 (Seamus Fernandez)。

Congrats on the quarter and the guidance. Can you just talk a little bit about subcutaneous KEYTRUDA, how you anticipate payers' acceptance of this new delivery modality as well as potential economic benefits to patients given the shift from Part B to Part D? I think there could be some benefits from the updated catastrophic cap being drivers there. But struggling in the face of potential biosimilars of KEYTRUDA after 2028 to see how payers would treat this. Just interested to have a little bit more color on the economic benefits, not just the benefits to the patients of subcutaneous KEYTRUDA.

恭喜本季和指引。您能簡單談談皮下注射 KEYTRUDA 嗎？您預計付款人如何接受這種新的給藥方式，以及從 B 部分轉向 D 部分給患者帶來的潛在經濟利益？我認為更新後的災難性上限可能會給那裡的司機帶來一些好處。但面對 2028 年後潛在的 KEYTRUDA 生物相似藥，付款人將如何處理這個問題，我們正在苦苦掙扎。只是想了解更多有關經濟效益的信息，而不僅僅是皮下注射 KEYTRUDA 對患者的好處。

So this is Dean. I'll take the first question, and then I'll hand it over to Rob and Caroline because the economic question and the payer is also related to the innovation that you provide. I just want to make sure that our way of thinking about something like pembro with hyaluronidase given as subcu is really there's going to be a call for that innovation.

這就是迪恩。我將回答第一個問題，然後將其交給羅布和卡羅琳，因為經濟問題和付款人也與您提供的創新有關。我只是想確保我們對像 pembro 和透明質酸酶 subcu 這樣的東西的思考方式確實會需要這種創新。

I'll just emphasize, we constantly speak about the earlier-stage cancer. And right now, we have 9 approvals. And as I've said in relationship in the prepared remarks, of those approvals, 2 -- the only 2 that have checkpoint inhibitors that OS benefit is KEYTRUDA base, which is early lung cancer and RCC.

我只是強調，我們經常談論早期癌症。目前，我們已獲得 9 項批准。正如我在準備好的發言中所說的那樣，在這些批准中，僅有 2 個具有檢查點抑制劑且 OS 受益的藥物是 KEYTRUDA 基礎藥物，即早期肺癌和腎細胞癌。

I actually just came from a meeting speaking to a bunch of thoracic oncologists in this, and it's quite interesting to hear how they speak for those who are thoracic oncologists, who are linked to a setting with medical oncologists, they very clearly understand why KEYNOTE-671 perioperative is a category 1.

實際上，我剛剛參加了一次會議，與一群胸部腫瘤學家進行了交談，聽到他們如何為那些與醫學腫瘤學家有聯繫的胸部腫瘤學家說話是非常有趣的，他們非常清楚地理解為什麼基調- 671 圍手術期屬於 1 類。

In situations where you may have a CT surgeon outside of a major care plan or a care -- a major medical center sometimes you have CT surgeons moonlighting doing lobectomies and resection for that, the KEYNOTE-091. And constantly, what we hear from the physicians and the provider, and many of them are in provider systems of all different types, is the need to have an alternative way to get the KEYTRUDA to them, either Q3, Q6 given the regimen. So I just want to emphasize that the subcu pembro plus hyaluronidase is an innovation that is going to be demanded and is being demanded by the field.

如果您可能在主要護理計劃或護理之外聘請 CT 外科醫生（大型醫療中心），有時您會請 CT 外科醫生兼職進行肺葉切除術和切除術，KEYNOTE-091。我們不斷地從醫生和提供者那裡聽到，他們中的許多人都在不同類型的提供者係統中，他們需要有一種替代方式來獲得 KEYTRUDA，無論是 Q3、Q6 方案。所以我只想強調，subcu pembro 加透明質酸酶是一項創新，該領域將會需要並且正在需要。

Yes. Thanks, Dean. And to the questions on the economics, and I think we've commented on this a little bit in various settings. But as we think about our strategy for bringing this to the market from a commercial perspective, our view is the quality-of-life benefits this brings does demonstrate and afford us the ability to get a premium price. But we also are very cognizant that any subcu pembro will have to be considered in the context of a generic IV version.

是的。謝謝，迪恩。至於有關經濟學的問題，我想我們已經在不同的場合對此進行了一些評論。但當我們從商業角度思考將其推向市場的策略時，我們的觀點是，它帶來的生活品質優勢確實證明並讓我們有能力獲得溢價。但我們也非常清楚，任何 subcu pembro 都必須在通用 IV 版本的背景下考慮。

So we will price our subcu to drive for volume and to do for conversion, which means we will be looking at prices really more in line with where you would see the generic version at a premium that history has shown is very manageable and expected and covered by payers today when you look at the different delivery for them. So in that sense, we think we will be able to manage this.

因此，我們將為我們的 subcu 定價，以推動銷售並進行轉換，這意味著我們將考慮更符合您所看到的通用版本溢價的價格，歷史表明這是非常易於管理、預期和覆蓋的今天，當您查看付款人的不同交付方式時，您會發現。所以從這個意義上說，我們認為我們將能夠解決這個問題。

The whole question of Part B versus Part D, we'll have to see how it plays out as far as the ultimate side of administration. But if it does end up being into the Part D category, which is a reasonable chance, you are correct in that some of the new coverages that are out there in catastrophic and with a cap, also then from a patient perspective, should lower the burden they're going to face, which we also think could help with conversion.

B 部分與 D 部分的整個問題，我們必須看看它在管理的最終方面如何發揮作用。但如果它最終確實屬於 D 部分類別，這是一個合理的機會，那麼您是正確的，因為一些新的災難性保險和有上限的保險，從患者的角度來看，應該會降低他們將面臨的負擔，我們也認為這有助於轉變。

Next, we'll go to the line of Geoff Meacham from Bank of America.

接下來，我們將接聽來自美國銀行的傑夫·米查姆 (Geoff Meacham) 的電話。

Caroline, on margins, you highlighted a benefit from KEYTRUDA and GARDASIL this year, which I think was expected. But looking forward, is the guidance this year a reasonable target until the KEYTRUDA LOE? I wasn't sure if there's other drivers going forward or whether mix could impact margins as well.

Caroline，在利潤方面，您強調了今年 KEYTRUDA 和 GARDASIL 帶來的好處，我認為這是預期的。但展望未來，在 KEYTRUDA LOE 之前，今年的指導是否是一個合理的目標？我不確定未來是否還有其他驅動因素，或者混合是否也會影響利潤率。

Thank you for the question, Geoff. So as you all know, our company has made great progress in expanding operating margin over a number of years. As we look to 2024, we expect operating margin to improve. And that's really driven by the strength of the top line and mix of revenue by the roll-off of royalties that we've noted on KEYTRUDA and GARDASIL, being disciplined in our expenses, while we do invest fully behind our expansive pipeline.

謝謝你的提問，傑夫。眾所周知，多年來我們公司在擴大營業利潤率方面取得了巨大進步。展望 2024 年，我們預期營業利潤率將有所改善。這實際上是由營收實力和收入組合推動的，我們在 KEYTRUDA 和 GARDASIL 上註意到了特許權使用費的下降，在我們確實全力投資於我們廣泛的管道的同時，嚴格控制我們的支出。

As we go beyond 2024, we still point to an operating margin of greater than 43% in 2025. But our focus as a company and as a team is to really ensure that we are fueling the pipeline, supporting the portfolio of products that we're launching to drive growth into the long term.

當我們超越 2024 年時，我們仍然預計 2025 年的營業利潤率將超過 43%。但作為一家公司和一個團隊，我們的重點是真正確保我們正在推動管道發展，支持我們的產品組合。重新啟動以推動長期成長。

Next, we'll go to the line of Steve Scala from TD Cowen.

接下來，我們將轉向 TD Cowen 的 Steve Scala。

I believe the Merck RSV monoclonal antibody Phase II/III study is registrational and reads out this year. Is that correct? And assuming positive, how soon could Merck be on the market? And how might this product be differentiated from by Fortis? It's just a little odd that this could be a $1 billion opportunity, not that far off, and Merck never talks about it.

我相信默克 RSV 單株抗體 II/III 期研究已註冊並於今年公佈。那是對的嗎？假設呈陽性，默克公司多久才能上市？該產品如何與富通的產品區分開來？有點奇怪的是，這可能是一個價值 10 億美元的機會，而且距離並不遙遠，而且默克從未談論過它。

I really appreciate the question, so I will talk about it. In relationship to the RSV monoclonal antibody, it's for the early birth. It's an antibody, it's passive immunization, and it's for the pediatric population. This is a single shot. This is not weight-based, and we believe it has a longer season in relationship to other choices. And so we think it's an important readout, and we're very excited and interested to move on this RSV monoclonal antibody.

我真的很感激這個問題，所以我會談談它。與RSV單株抗體相關，它是為了早產。它是一種抗體，是被動免疫，適用於兒科族群。這是單次拍攝。這不是基於體重的，我們相信它比其他選擇有更長的季節。因此，我們認為這是一個重要的讀數，我們對繼續研究這種 RSV 單株抗體感到非常興奮和感興趣。

I would also emphasize that the New England Journal of Medicine just published a series of papers, not in RSV, but also in dengue that also we're very excited about. And we're moving that forward quickly. And then more broadly from the ID vaccine, I've said previously that I'm very intrigued to see the results of our NRTTI islatravir and our other NRTTI, MK-8527. So that will also be coming out this year. We'll be able to see those. So it is the RSV. It is the dengue that was just out there, and it is the HIV data that we're going to be very interested in seeing across this year.

我還要強調的是，《新英格蘭醫學雜誌》剛剛發表了一系列論文，不僅是 RSV，而且還有登革熱，我們對此感到非常興奮。我們正在迅速推進這一進程。然後從更廣泛的 ID 疫苗來看，我之前說過，我對我們的 NRTTI islatravir 和我們的其他 NRTTI MK-8527 的結果非常感興趣。所以今年也會推出。我們將能夠看到這些。這就是RSV。這是剛出現的登革熱，也是我們今年將非常感興趣的愛滋病毒數據。

Yes. And Steve, just to maybe, from a commercial perspective, build on the question, from a launch timing perspective, our expectation is that we would be in the market in 2025. And obviously, we're working to be ready for that season in 2025.

是的。史蒂夫，也許，從商業角度來看，從發佈時間的角度來看，我們的期望是我們將在 2025 年進入市場。顯然，我們正在努力為 2025 年的那個季節做好準備。2025 年。

And then from -- a differentiator for us, recall that our coverage covers what is the full prevention season for RSV, which is 5 to 6 months. We're a single fixed dose, not a weight-based administered shot. So for us, those are all very important things.

然後，我們的一個區別是，我們的承保範圍涵蓋 RSV 的完整預防季節，即 5 到 6 個月。我們是單一固定劑量，而不是基於體重的注射。所以對我們來說，這些都是非常重要的事情。

And the last thing I'd note is the site of action for us is really, we think, has low risk of development of resistance and is different than the competition. So we actually are very bullish on this. I think we don't talk about it, frankly, because we have so many other good things to talk about. It sometimes gets lost. But it doesn't mean we're not excited about this and/or dengue, which frankly, I still believe dengue is a little bit, obviously, later than this but huge for us. So those are things we're excited about. It just reinforces the breadth of the portfolio we have.

我要指出的最後一件事是，我們認為，我們的行動地點確實具有低抗藥性發展的風險，並且與競爭對手不同。所以我們其實非常看好這一點。坦白說，我認為我們不會談論它，因為我們還有很多其他好事情要談論。有時它會迷路。但這並不意味著我們對這種情況和/或登革熱不感到興奮，坦白說，我仍然相信登革熱顯然比這晚一點，但對我們來說意義重大。這些都是我們感到興奮的事情。它只是加強了我們投資組合的廣度。

Next, we'll go to the line of Chris Shibutani from Goldman Sachs.

接下來，我們將邀請高盛 (Goldman Sachs) 的 Chris Shibutani。

If I could ask about immunology, essentially a reentry into that realm with the Prometheus acquisition. If you could just update us on what we should be expecting to learn and also what you find interesting perhaps being to further build out on the immunology platform. Specifically, the clinicaltrials.gov has the Phase II maintenance data in UC is enrolling. Should we expect to hear from you on results there?

如果我可以詢問免疫學，本質上是透過收購普羅米修斯重新進入該領域。如果您能為我們提供最新信息，告訴我們我們應該學習什麼，以及您發現有趣的事情，也許是在免疫學平台上進一步構建。具體來說，clinicaltrials.gov 擁有 UC 正在招募的 II 期維護資料。我們應該期待收到您關於那裡結果的消息嗎？

I did not observe something there on Crohn's disease. What's the update on that program? And then in immunology further, it appeared from the start of the year a lot of excitement about different modalities, cell therapies in particular, oral advanced treatments. Share with us some views on where you think immunology could go to take Merck to be a relevant presence in the 2030s.

我沒有觀察到有關克羅恩病的資訊。該程式有什麼更新？然後在免疫學方面，從今年年初開始，人們對不同的治療方式，尤其是細胞療法，特別是口服先進治療產生了許多興奮。請與我們分享一些您認為免疫學可以使默克在 2030 年代佔據重要地位的觀點。

Chris, that's a great question and an expansive question. So let me just hit in relationship to the TL1A antibody. We have our ulcerative colitis trial moving forward, and that's been listed and that's moving forward.

克里斯，這是一個很好的問題，也是一個廣泛的問題。那麼讓我簡單談談 TL1A 抗體的關係。我們的潰瘍性結腸炎試驗正在向前推進，並且已經被列出並且正在向前推進。

I think probably the really important thing for me that I look out is getting the Crohn's disease trial moving. The reason I think it's really important is I'll remind myself that TL1A is in the super TNF family. But TL1A may be different than run-of-the-mill TNF in its ability to not just dampen inflammation but affect fibrosis.

我認為對我來說真正重要的事情可能是推動克羅恩病試驗。我認為這非常重要的原因是我會提醒自己 TL1A 屬於超級 TNF 家族。但 TL1A 可能與普通的 TNF 不同，它不僅能夠抑制炎症，還能影響纖維化。

So going from ulcerative colitis to Crohn's disease, Crohn's disease has lots of strictures in this. That will be important. And it will be also important to look and follow -- I follow our data in TL1A in relationship to lung disease and scleroderma. So that's with that.

因此，從潰瘍性結腸炎到克隆氏症，克隆氏症在這方面有許多限制。這很重要。觀察和追蹤也很重要——我追蹤 TL1A 中與肺部疾病和硬皮症相關的數據。就這樣了。

I would also emphasize that there are other assets within the partnership or acquisition that we did with Prometheus and those compounds, which had already been discussed previously, are advancing through the pipeline as well.

我還要強調的是，我們與 Prometheus 的合作或收購中還有其他資產，之前已經討論過的那些化合物也正在透過管道推進。

And then the other question that you have is, are we interested in other platforms moving forward? The answer is absolutely yes. I think you had a question in terms of cell therapy with immunology. I think there is interesting there. But as you know, we've -- when we've looked at cell therapy in relationship to cancer, especially not in heme, but in solid, we've been a little bit probably more exploratory. And right now, our view of cell therapy in immunology is one that might be more similar to our view of cell therapy in solid tumor, a little bit more exploratory.

然後你的另一個問題是，我們對其他平台的發展感興趣嗎？答案是肯定的。我認為您對細胞免疫學治療有疑問。我認為那裡很有趣。但如你所知，當我們研究細胞療法與癌症的關係時，特別是不是血紅素療法，而是固體療法，我們可能會更具探索性。目前，我們對免疫學細胞治療的看法可能與我們對實體瘤細胞治療的看法更相似，更具探索性。

And for our final question, we'll go to the line of Louise Chen from Cantor Fitzgerald.

對於我們的最後一個問題，我們將求助於坎托·菲茨杰拉德 (Cantor Fitzgerald) 的路易絲·陳 (Louise Chen)。

I just wanted to ask you on your ADC platform, if you feel that what you have is enough for now or do you want to expand or add on to it. And any interest in radiopharmaceuticals?

我只是想問一下你們的ADC平台，你們是否覺得目前擁有的已經足夠了，或者你們想擴展或添加它嗎？對放射性藥物有興趣嗎？

Thank you very much for that question. So when we think about tissue targeting, we think of ADCs. And the answer is, I think the ADC fields will continue to develop, and I think there will be other payloads, other linkers, but also the specificity by which you do the tissue targeting in relationship to the antibody may change.

非常感謝你提出這個問題。因此，當我們考慮組織靶向時，我們會想到 ADC。答案是，我認為 ADC 領域將繼續發展，我認為還會有其他有效負載、其他連接器，而且與抗體相關的組織靶向的特異性也可能會改變。

There's also clearly evidence of potential movements into peptide drug conjugates that we're interested in as well as the possibility that the payload is no longer chemotherapy-based, but other sort of compound-based. So we're interested in that.

還有明顯的證據表明我們感興趣的勝肽藥物綴合物的潛在發展，以及有效負載不再基於化療，而是基於其他類型化合物的可能性。所以我們對此很感興趣。

In tissue targeting more broadly, we are interested. And so we view that as, okay, that's how we're going to move sort of toxic cell chemotherapy agents into tissue targeting sort of scheme making chemotherapy precision medicine. But we also are very interested in the IO space in relationship to tissue targeting, and that is -- our foray in that is really helped by our proposed acquisition with Harpoon that has a very interesting asset in relationship to tissue targeting and immune engagers.

我們對更廣泛的組織靶向感興趣。因此，我們認為，好吧，這就是我們如何將有毒細胞化療藥物轉移到組織靶向方案中，從而實現化療精準醫學。但我們也對與組織靶向相關的IO 領域非常感興趣，也就是說，我們對Harpoon 的收購確實有助於我們在這方面的嘗試，Harpoon 在組織靶向和免疫參與劑方面擁有非常有趣的資產。

Great. Thank you, Louise, and thank you all for the really good questions and appreciate you sticking to mostly one question. We got through a lot of questioners, so appreciate that. If you have any follow-ups, please reach out to IR. We'll be seeing you soon. Thank you.

偉大的。謝謝你，路易絲，謝謝你們提出的非常好的問題，並感謝你們堅持主要回答一個問題。我們回答了很多提問者，非常感謝。如果您有任何後續行動，請聯絡 IR。我們很快就會見到你。謝謝。

Thank you all for participating in the Merck & Co. Q4 Sales and Earnings Conference Call. That concludes today's conference. Please disconnect at this time, and have a great rest of your day.

感謝大家參加默克公司第四季銷售和收益電話會議。今天的會議到此結束。請此時斷開連接，好好休息一下。