默克藥廠 (MRK) 2022 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good morning. My name is Alan, and I will be your conference moderator today. At this time, I would like to welcome everyone to the Merck & Co. Q2 Sales and Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. Thank you. I would now like to turn the conference over to Peter Dannenbaum, VP Investor Relations. Please go ahead.

女士們，先生們，謝謝你們的支持。早上好。我叫艾倫，今天我將擔任您的會議主持人。在這個時候，我想歡迎大家參加默克公司第二季度銷售和收益電話會議。 （操作員說明）作為提醒，本次會議正在錄製中。謝謝你。我現在想將會議轉交給投資者關係副總裁 Peter Dannenbaum。請繼續。

Welcome to Merck's Second Quarter 2022 Conference Call. Speaking on today's call will be Rob Davis, President and Chief Executive Officer; Caroline Litchfield, Chief Financial Officer; and Dr. Dean Li, President of Merck Research Labs.

歡迎來到默克公司 2022 年第二季度電話會議。在今天的電話會議上發言的將是總裁兼首席執行官 Rob Davis； Caroline Litchfield，首席財務官；默克研究實驗室總裁李院長博士。

Before we get started, I'd like to point out a few items. You'll 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. 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.

在我們開始之前，我想指出一些項目。您會看到我們的 GAAP 結果中有一些項目，例如與收購相關的費用、重組成本和某些其他項目。您應該注意，我們已將這些從我們的非公認會計原則結果中排除，並在我們的新聞稿中提供了對賬。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的安全港條款含義內的前瞻性陳述。這些陳述是基於當前的信念做出的默克的管理層，並受到重大風險和不確定性的影響。

If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2021 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.

如果我們的基本假設被證明不准確或不確定性成為現實，實際結果可能與前瞻性陳述中所述的結果大不相同。我們向美國證券交易委員會提交的文件，包括 2021 年 10-K 中的第 1A 項，確定了可能導致公司的實際結果與我們今天上午做出的任何前瞻性陳述中預測的結果存在重大差異的某些風險因素和警示性陳述。默克不承擔公開更新任何前瞻性陳述的義務。

During today's call, a slide presentation will accompany our speaker's prepared remarks. The presentation of today's earnings release as well as 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。今天的收益發布以及我們提交給美國證券交易委員會的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.

有了這個，我想把電話轉給 Rob。

Thanks, Peter. Good morning, and thank you for joining today's call. I'm proud to report that the business continues to perform extremely well. We remain firmly guided by our strategic priorities to drive long-term growth and deliver value to patients and shareholders. We're executing on the opportunities in front of us today, while simultaneously making the necessary investments to sustain our success long into the future. I'm pleased to report that during the second quarter, we achieved robust top and bottom line growth and made additional important clinical advancements in our pipeline.

謝謝，彼得。早上好，感謝您加入今天的電話會議。我很自豪地報告，該業務繼續表現出色。我們仍然堅定地遵循我們的戰略重點，以推動長期增長並為患者和股東創造價值。我們正在抓住今天擺在我們面前的機會，同時進行必要的投資以在未來長期保持成功。我很高興地報告，在第二季度，我們實現了強勁的頂線和底線增長，並在我們的管道中取得了額外的重要臨床進展。

Turning first to our results. We again achieved exceptional performance this quarter led by strong growth of key products, including KEYTRUDA, GARDASIL and BRIDION. Our results were aided by revenue from LAGEVRIO, which is helping to in fighting against COVID-19. We're confident in the underlying demand for our innovative portfolio as we continue to see momentum in our business, which we are pleased to reflect in our updated guidance.

首先談談我們的結果。在 KEYTRUDA、GARDASIL 和 BRIDION 等關鍵產品的強勁增長的帶動下，我們在本季度再次取得了卓越的業績。我們的結果得益於 LAGEVRIO 的收入，這有助於對抗 COVID-19。我們對我們的創新產品組合的潛在需求充滿信心，因為我們繼續看到我們的業務發展勢頭，我們很高興在我們更新的指導中反映出來。

Moving to research organization. We continue to advance our pipeline most significantly across our suite of pneumococcal conjugate vaccines. VAXNEUVANCE received an expanded approval from the FDA for pediatric use, providing an important option for children in prevention of invasive pneumococcal disease.

轉到研究機構。我們繼續在我們的肺炎球菌結合疫苗套件中最顯著地推進我們的管道。 VAXNEUVANCE 獲得了 FDA 對兒科使用的擴大批准，為兒童預防侵襲性肺炎球菌疾病提供了重要選擇。

We also presented positive results from clinical studies of V116, our pneumococcal conjugate vaccine candidate, designed specifically to address remaining disease burden in adults, and we've initiated pivotal phase III studies. These milestones reinforce the confidence we have in our population specific approach to address the distinct needs of children and adults.

我們還展示了我們的肺炎球菌結合疫苗候選疫苗 V116 的臨床研究的積極結果，該疫苗專為解決成人剩餘的疾病負擔而設計，我們已經啟動了關鍵的 III 期研究。這些里程碑增強了我們對滿足兒童和成人不同需求的特定人群方法的信心。

We've also taken additional steps to help you understand the significant opportunities we see in our pipeline. In June, we hosted an investor event at ASCO which highlighted the depth and breadth of our oncology program. At the event, we reiterated our ambition to become the leading oncology company by 2025 and our goal of sustaining this success well into the next decade.

我們還採取了額外的措施來幫助您了解我們在管道中看到的重要機會。 6 月，我們在 ASCO 舉辦了一場投資者活動，突出了我們腫瘤學項目的深度和廣度。在此次活動中，我們重申了到 2025 年成為領先的腫瘤學公司的雄心，以及我們將這一成功延續到下一個十年的目標。

As I reflect on my first year as CEO, I'm very pleased by the significant progress we've made in advancing Merck's position as a global biopharmaceutical leader and the scent of momentum spreading across our business. The unwavering focus and dedication of our employees worldwide is driving strong execution on the significant opportunities in front of us. We're demonstrating impressive resilience across all aspects of our business in a very challenging global environment.

當我回顧我擔任首席執行官的第一年時，我對我們在提升默克公司作為全球生物製藥領導者的地位方面取得的重大進展以及在我們業務中蔓延的勢頭感到非常高興。我們全球員工堅定不移的專注和奉獻精神正在推動我們對擺在我們面前的重大機遇的有力執行。在極具挑戰性的全球環境中，我們在業務的各個方面都表現出令人印象深刻的韌性。

We're achieving record levels of production in our manufacturing operations, delivering exceptionally strong revenue growth, making meaningful advances in our pipeline and taking important steps to be more transparent about our outlook.

我們在製造業務中實現了創紀錄的生產水平，實現了異常強勁的收入增長，在我們的管道中取得了有意義的進步，並採取了重要措施來使我們的前景更加透明。

Our strategy is working and our future is bright. I was very confident a year ago, and I'm even more confident today that we are well positioned to achieve our near and long-term goals, anchored by our commitments to deliver important medicines and vaccines to patients and value to all of our stakeholders, including shareholders.

我們的戰略正在奏效，我們的未來是光明的。一年前我非常有信心，今天我更加有信心，我們有能力實現我們的近期和長期目標，這以我們為患者提供重要藥物和疫苗的承諾為基礎，並為我們所有的利益相關者提供價值，包括股東。

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

有了這個，我會把電話轉給卡羅琳。

Thank you, Rob. Good morning. As Rob highlighted, we are maintaining this year's strong momentum with another quarter of exceptional performance in both revenue and earnings. These results further demonstrate that our focus on science and innovation as the core of our strategy is working. Our success is being enabled by the excellent execution of our dedicated colleagues across the globe and continue to deliver value for patients, customers and shareholders.

謝謝你，羅布。早上好。正如 Rob 強調的那樣，我們保持了今年的強勁勢頭，在收入和收益方面又取得了一個季度的出色表現。這些結果進一步表明，我們以科學和創新為核心的戰略正在發揮作用。我們的成功得益於我們在全球範圍內敬業的同事的出色執行，並繼續為患者、客戶和股東創造價值。

Total company revenues were $14.6 billion, an increase of 28%. LAGEVRIO contributing $1.2 billion in revenue. Excluding LAGEVRIO, the business delivered very strong growth of 18%.

公司總收入為 146 億美元，增長 28%。 LAGEVRIO 貢獻了 12 億美元的收入。不包括 LAGEVRIO，該業務實現了 18% 的強勁增長。

The remainder of my comments will be on an ex-exchange basis. Our Human Health business continued its strong momentum with growth of 33% or 21%, excluding LAGEVRIO driven by our key pillars. Our Animal Health business also delivered stellar performance, with sales increasing 5%, driven by growth across both our livestock and companion animal products.

我的其餘評論將以交換為基礎。我們的人類健康業務繼續保持強勁勢頭，增長 33% 或 21%，不包括由我們的主要支柱驅動的 LAGEVRIO。我們的動物保健業務也表現出色，銷售額增長了 5%，這得益於我們的牲畜和伴侶動物產品的增長。

Now turning to the second performance of our key brands. In oncology, KEYTRUDA grew 30% to $5.3 billion, driven by the vast global demand as well as continued expansion into new indications and to reflect the profound impact it is having on patients across the globe. In the U.S., KEYTRUDA continues to demonstrate momentum in metastatic indication and is experiencing strong growth from recent launches in early-stage cancers, including triple-negative breast, renal cell carcinoma and melanoma. KEYTRUDA is now approved with 6 indications in earlier stage cancers.

現在轉向我們主要品牌的第二個表現。在腫瘤學領域， KEYTRUDA 增長 30% 至 53 億美元，這得益於全球需求的巨大增長以及新適應症的持續擴張，並反映了它對全球患者的深遠影響。在美國， KEYTRUDA 繼續顯示出轉移適應症的勢頭，並且從最近推出的早期癌症（包括三陰性乳腺癌、腎細胞癌和黑色素瘤）中經歷了強勁的增長。 KEYTRUDA 現在被批准用於早期癌症的 6 種適應症。

We've seen strong utilization and are confident in its continued success as physician and patient experience growth. We have seen a particularly strong uptake in neoadjuvant, adjuvant, high risk early-stage triple-negative breast cancer based on KEYNOTE-522, offering a systemic treatment option to patients in an area of significant unmet need.

隨著醫生和患者體驗的增長，我們已經看到了強大的利用率，並對它的持續成功充滿信心。我們已經看到基於 KEYNOTE-522 的新輔助、輔助、高風險早期三陰性乳腺癌的吸收特別強烈，為處於重大未滿足需求領域的患者提供了系統性治療選擇。

In the metastatic setting, KEYTRUDA maintained its leadership position in non-small lung cancer, capturing 8 out of 10 eligible new patients. Outside the U.S., KEYTRUDA was driven by continued uptake in non-small cell lung cancer and the ongoing launches in head and neck cancer and renal cell carcinoma. Initial indicators also point to encouraging trends in the earliest stage indications, including triple-negative breast cancer and renal cell carcinoma in key European markets.

在轉移性環境中， KEYTRUDA 保持了其在非小細胞肺癌領域的領先地位，在 10 名符合條件的新患者中獲得了 8 名。在美國以外， KEYTRUDA 受到非小細胞肺癌的持續吸收以及頭頸癌和腎細胞癌的持續推出的推動。初步指標還表明，早期適應症的趨勢令人鼓舞，包括歐洲主要市場的三陰性乳腺癌和腎細胞癌。

Lynparza remains a market-leading part inhibitor. Our alliance revenue grew 17%, driven by uptaking certain patients with high-risk early-stage breast cancer following FDA approval based on the OlympiA study. We look forward to potentially expanding upon Lynparza's leadership by reaching additional prostate cancer patients based on the PROpel study.

Lynparza 仍然是市場領先的部分抑製劑。在 FDA 根據 OlympiA 研究批准後，我們的聯盟收入增長了 17%，這是由於接受了某些患有高風險早期乳腺癌的患者。我們期待通過基於 PROpel 研究的更多前列腺癌患者來擴大 Lynparza 的領導地位。

Lenvima alliance revenue grew 33% due to strong demand following the launch of KEYNOTE-581 in advanced renal cell carcinoma and KEYNOTE-775 in metastatic endometrial cancer. New patient states across each of these tumors remain strong. Lastly, we continue to be encouraged by the uptake of WELIREG which is tracking in line with expectations.

由於在晚期腎細胞癌中推出 KEYNOTE-581和在轉移性子宮內膜癌中推出 KEYNOTE-775後需求強勁， Lenvima 聯盟收入增長了 33%。這些腫瘤中的每一個的新患者狀態仍然很強勁。最後，我們繼續對 WELIREG 的採用感到鼓舞，它的跟踪符合預期。

Our vaccines portfolio again delivered excellent growth, led by GARDASIL, which increased 40% to $1.7 billion. Outside the U.S., GARDASIL significant growth was driven by strong underlying demand, particularly in China as well as increased supply. In the U.S. sales decreased primarily due to CDC purchasing patterns, although we continue to see some impact from the pandemic on well visits.

在 GARDASIL 的帶動下，我們的疫苗組合再次實現了出色的增長，增長了 40%，達到 17 億美元。在美國以外，GARDASIL 的顯著增長是由強勁的潛在需求推動的，尤其是在中國以及供應增加。在美國，銷售額下降的主要原因是 CDC 採購模式，儘管我們繼續看到大流行對油井訪問產生了一些影響。

We continue to invest behind activation campaigns to ensure that parents recognize the importance of routine physician well visits for their children, particularly during the back-to-school season. We remain confident in the growth trajectory of GARDASIL given the proven ability to help prevent certain HPV-related cancers in both females and males.

我們將繼續投資於激活活動，以確保父母認識到常規醫生就診對孩子的重要性，尤其是在返校季節。我們對 GARDASIL 的增長軌跡仍然充滿信心，因為它已證明能夠幫助預防女性和男性的某些 HPV 相關癌症。

In our hospital acute care portfolio, BRIDION sales grew 15%, driven by greater share among neuromuscular blockage reversal agents and an increase in surgical procedures. Our animal health business delivered another solid quarter, with sales increasing 5%, livestock sales grew 6%, driven by higher demand in ruminants and poultry. Companion animal sales increased 3% due to global demand for the BRAVECTO line of product.

在我們的醫院急症護理產品組合中，BRIDION 的銷售額增長了 15%，這得益於神經肌肉阻滯逆轉劑中更大的份額和外科手術的增加。在反芻動物和家禽需求增加的推動下，我們的動物保健業務又實現了一個穩健的季度，銷售額增長了 5%，牲畜銷售額增長了 6%。由於全球對 BRAVECTO 系列產品的需求，伴侶動物的銷售額增長了 3%。

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 74.7%, a decrease of 1.8 percentage points. The decrease was due to the impact of LAGEVRIO, higher inventory write-offs due to increased manufacturing costs, partially offset by favorable product mix across the remainder of the portfolio and foreign exchange.

我現在將向您介紹我們的損益表的其餘部分，我的評論將基於非公認會計原則。毛利率為74.7%，下降1.8個百分點。下降的原因是 LAGEVRIO 的影響，由於製造成本增加導致庫存沖銷增加，部分被其餘投資組合和外彙的有利產品組合所抵消。

Operating expenses decreased 19% to $5.2 billion, reflecting charges primarily related to last year's $1.7 billion acquisition of Pandion which is reflected in our second quarter 2021 R&D expense. Operating expenses excluding these charges increased in line with our plan, driven by investments in our key growth drivers and pipeline. Other expense was approximately $200 million, reflecting higher-than-expected pension settlement expense. Our tax rate was 13.8%. Taken together, we add $1.87 per share.

運營費用下降 19% 至 52 億美元，主要與去年以 17 億美元收購 Pandion 有關的費用反映在我們 2021 年第二季度的研發費用中。不包括這些費用的運營費用按照我們的計劃增加，這是由於對我們的主要增長動力和管道的投資。其他費用約為 2 億美元，反映出養老金結算費用高於預期。我們的稅率是 13.8%。加在一起，我們每股增加 1.87 美元。

Turning now to our 2022 non-GAAP guidance. The underlying strength of our business enables us to raise and narrow our full year revenue guidance. We now expect revenue to be between $57.5 billion and $58.5 billion. Our increased revenue guidance range represents growth of 18% to 20% or 13% to 14%, excluding LAGEVRIO and the impact from foreign exchange.

現在轉向我們的 2022 年非 GAAP 指導。我們業務的潛在優勢使我們能夠提高和縮小全年收入指導。我們現在預計收入將在 575 億美元至 585 億美元之間。我們增加的收入指導範圍代表增長 18% 至 20% 或 13% 至 14%，不包括 LAGEVRIO 和外匯影響。

The projected impact from foreign exchange includes an incremental headwind of more than 1% using mid-July rates resulting in a full year negative impact of approximately 3%. We are maintaining our gross margin expectation of between 74% and 74.5%. We are increasing our operating expense projection to $20.5 billion to $21.5 billion, primarily driven by the $219 million upfront payment from the recently announced collaboration with Orion Corporation.

預計來自外彙的影響包括使用 7 月中旬的利率增加超過 1% 的逆風，從而導致全年約 3% 的負面影響。我們將毛利率預期維持在 74% 至 74.5% 之間。我們正在將我們的運營費用預測提高到 205 億美元至 215 億美元，這主要得益於最近宣布與 Orion Corporation 合作的 2.19 億美元預付款。

As an ongoing practice, our guidance does not include significant potential business development transaction. We increased our expectations of other expense to approximately $500 million, reflecting higher-than-anticipated pension settlement expense. We continue to assume a full year tax rate between 13.5% and 14.5%. We assumed 2.54 billion shares outstanding.

作為一項持續的實踐，我們的指導不包括重大的潛在業務發展交易。我們將其他費用的預期提高到約 5 億美元，反映出養老金結算費用高於預期。我們繼續假設全年稅率在 13.5% 和 14.5% 之間。我們假設有 25.4 億股流通股。

Taken together, we have narrowed our expected EPS range to $7.25 to $7.35. The operational strength in our business would have led to an approximately $0.25 increase in our guidance. This strength is being offset by the upfront payment to Orion, by a pension settlement expense and an incremental headwind from foreign exchange of more than 1% using mid-July rates. Overall, our guidance reflects our confidence that the strong underlying momentum of our business will continue into the second half of the year.

綜上所述，我們已將預期每股收益範圍縮小至 7.25 美元至 7.35 美元。我們業務的運營實力將導致我們的指導增加約 0.25 美元。這種優勢被 Orion 的預付款、養老金結算費用以及使用 7 月中旬匯率帶來的超過 1% 的外匯逆風所抵消。總體而言，我們的指引反映了我們對我們業務強勁的潛在勢頭將持續到下半年的信心。

As you consider your models, there are a few things to keep in mind. First, the pandemic was a tailwind to growth in the first half of the year. We expect the benefits to year-over-year growth to lessen over the remainder of the year. Also, we actively managed the impact of foreign exchange through our revenue setting program. To the extent we see further negative impact from foreign exchange, we will see additional benefits from our hedges in other revenues as we did in this quarter.

當你考慮你的模型時，有一些事情需要記住。首先，疫情對上半年的增長起到了推動作用。我們預計今年剩餘時間對同比增長的好處將減少。此外，我們通過收入設定計劃積極管理外彙的影響。如果我們看到外匯帶來的進一步負面影響，我們將看到我們在其他收入中的對沖帶來的額外好處，就像我們在本季度所做的那樣。

Other revenue also includes supply sales to Organon and to Johnson & Johnson for its COVID-19 vaccine as well as receipts related to out licensing arrangements. In total, we expect other revenue to be higher in the second half versus the first half of 2022. With respect to our products, for PNEUMOVAX23, we continue to expect a negative impact to U.S. sales, given the shift towards newer adults pneumococcal conjugate vaccines.

其他收入還包括向歐加農和強生公司的 COVID-19 疫苗供應銷售，以及與許可安排相關的收入。總體而言，我們預計下半年的其他收入將高於 2022 年上半年。關於我們的產品，對於 PNEUMOVAX23，鑑於轉向新型成人肺炎球菌結合疫苗，我們繼續預計對美國的銷售產生負面影響.

On Animal Health, we're seeing normalized industry growth rate as we (inaudible) the favorable trends in spending resulting from the pandemic and experience foreign exchange headwinds. However, given our broad and innovative portfolio, we are well positioned to continue to drive above market growth in 2022 and beyond. Finally, we continue to expect to expect LAGEVRIO's full year sales of $5 billion to $5.5 billion, with second half sales weighted to the fourth quarter.

在動物保健方面，我們看到了正常化的行業增長率，因為我們（聽不清）大流行導致支出的有利趨勢並經歷了外匯逆風。然而，鑑於我們廣泛而創新的產品組合，我們有能力在 2022 年及以後繼續推動高於市場的增長。最後，我們繼續預計 LAGEVRIO 的全年銷售額為 50 億美元至 55 億美元，下半年銷售額加權至第四季度。

Our capital allocation priorities remain unchanged. We will continue to prioritize investments in our pipeline and business to realize the value of the many near and long-term opportunities in front of us. We continue to pursue compelling external science through with strategic business development to augment our internal pipeline. Our recent collaboration with Orion is another example of our execution of this strategy. We remain committed to our dividend, which we expect to increase through the time. Finally, to the extent we have excess cash, we will return it to shareholders through share repurchases.

我們的資本配置重點保持不變。我們將繼續優先投資我們的管道和業務，以實現我們面前許多近期和長期機會的價值。我們通過戰略業務發展繼續追求引人注目的外部科學，以擴大我們的內部管道。我們最近與 Orion 的合作是我們執行這一戰略的另一個例子。我們仍然致力於我們的股息，我們預計隨著時間的推移會增加。最後，如果我們有多餘的現金，我們將通過股票回購將其返還給股東。

To conclude, as we enter the second half of the year, we remain very confident in strength of our business, driven by global demand for our innovative medicines and vaccines. Our excellent execution will enable us to continue to deliver value to patients and shareholders well into the future.

總而言之，隨著我們進入下半年，在全球對我們創新藥物和疫苗的需求的推動下，我們對我們的業務實力仍然充滿信心。我們出色的執行力將使我們能夠在未來繼續為患者和股東創造價值。

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 Dean。

Thank you, Caroline. It's my pleasure to provide an update on our progress since the first quarter call. We continue to execute on our pipeline strategy. We are advancing the latest signs to generate medicines and vaccines that provide clear benefit for patients.

謝謝你，卡羅琳。我很高興提供自第一季度電話會議以來我們進展的最新情況。我們繼續執行我們的管道戰略。我們正在推進最新跡象，以生產為患者帶來明顯益處的藥物和疫苗。

Today, I will highlight recent progress in our vaccine pipeline and provide updates on our oncology program as well as LAGEVRIO. As Rob noted, we have made significant progress across our pneumococcal portfolio. Building upon the approval in the adult indication we received a year ago, last month, we received FDA approval for our 15-valent pneumococcal conjugate vaccine, VAXNEUVANCE, an important new option to help protect pediatric populations against invasive pneumococcal disease.

今天，我將重點介紹我們疫苗管道的最新進展，並提供我們的腫瘤學項目以及 LAGEVRIO 的最新信息。正如 Rob 所指出的，我們在肺炎球菌產品組合方面取得了重大進展。基於我們在一年前獲得的成人適應症的批准，上個月，我們獲得了 FDA 對我們的 15 價肺炎球菌結合疫苗 VAXNEUVANCE 的批准，這是一種幫助保護兒科人群免受侵襲性肺炎球菌疾病侵害的重要新選擇。

VAXNEUVANCE is the first pneumococcal conjugate vaccine approved for pediatric populations in almost a decade. VAXNEUVANCE provides comparable immunogenicity for 12 shared serotypes compared to the currently available 13-valent pneumococcal conjugate vaccine, improved immunogenicity for serotype 3 and expanded coverage for serotype 22F and 33F. Serotype 3, 22F and 33F are key invasive disease-causing serotypes known to be responsible for more than a quarter of all invasive pneumococcal disease in children.

VAXNEUVANCE 是近十年來首個獲准用於兒科人群的肺炎球菌結合疫苗。與目前可用的 13 價肺炎球菌結合疫苗相比，VAXNEUVANCE 為 12 種共有血清型提供了相當的免疫原性，提高了 3 型血清型的免疫原性並擴大了 22F 和 33F 血清型的覆蓋範圍。血清型 3、22F 和 33F 是主要的侵襲性致病血清型，已知佔兒童所有侵襲性肺炎球菌疾病的四分之一以上。

Following FDA approval, the CDC's Advisory Committee on Immunization Practices voted unanimously to endorse use of VAXNEUVANCE as an option for children under 19 years of age. Additionally, the ACIP unanimously voted to include VAXNEUVANCE and the vaccines for children program. We await publication of the final CDC recommendation in the morbidity and mortality weekly report.

在 FDA 批准後，CDC 免疫實踐諮詢委員會一致投票支持將 VAXNEUVANCE 用作 19 歲以下兒童的一種選擇。此外，ACIP 一致投票將 VAXNEUVANCE 和兒童疫苗計劃納入其中。我們等待在發病率和死亡率週報中公佈最終的 CDC 建議。

Also in June, at the International Symposium on Pneumococci and Pneumococcal Diseases in Toronto, we presented positive results from our Phase I/II study evaluating V116, our investigational 21-valent pneumococcal conjugate vaccine in pneumococcal vaccine naive adult. V116 is designed to significantly expand coverage compared to currently licensed pneumococcal vaccines by targeting serotypes that account for 85% of all invasive pneumococcal disease cases in adults aged 65 and older in the United States as of 2019.

同樣在 6 月，在多倫多舉行的肺炎球菌和肺炎球菌疾病國際研討會上，我們展示了評估 V116 的 I/II 期研究的積極結果，V116 是我們在未接種肺炎球菌疫苗的成人中研究的 21 價肺炎球菌結合疫苗。與目前許可的肺炎球菌疫苗相比，V116 旨在通過針對截至 2019 年占美國 65 歲及以上成年人所有侵襲性肺炎球菌疾病病例的 85% 的血清型來顯著擴大覆蓋範圍。

As a strong indicator of our progress, we recently enrolled the first patient into the STRIDE-3 trial evaluating V116 in vaccine-naive adult, the first of 4 current Phase III trial. We have taken a thoughtful and tailored approach to establishing a pipeline of pneumococcal vaccine candidate designed to afford the protection by targeting strains posing the greatest risk to specific populations. I look forward to providing additional updates on the progress of our pneumococcal program for VAXNEUVANCE, V116 and V117, our investigational candidate, specifically targeting pediatric disease.

作為我們進展的有力指標，我們最近將第一位患者納入了 STRIDE-3 試驗，該試驗在未接種疫苗的成人中評估 V116，這是當前 4 項 III 期試驗中的第一項。我們採取了深思熟慮和量身定制的方法來建立肺炎球菌候選疫苗管道，旨在通過針對對特定人群構成最大風險的菌株來提供保護。我期待就我們的 VAXNEUVANCE、V116 和 V117（我們的研究候選藥物，特別針對兒科疾病）肺炎球菌項目的進展提供更多更新。

Turning to oncology. We continue to build on the momentum in earlier-stage cancers. We announced that the FDA has accepted our application of KEYTRUDA for the adjuvant treatment for patients with non-small cell lung cancer following surgical resection based on the results of the ongoing KEYNOTE-091 trial. The FDA has set a Prescription Drug User Fee Act date of January 29, 2023. However, further data may be provided during the review process that may delay this date.

轉向腫瘤學。我們繼續在早期癌症的勢頭上再接再厲。我們宣布，根據正在進行的 KEYNOTE-091 試驗的結果，FDA 已接受我們的 KEYTRUDA 申請，用於手術切除後非小細胞肺癌患者的輔助治療。 FDA 已將處方藥用戶費用法案的日期定為 2023 年 1 月 29 日。但是，在審查過程中可能會提供進一步的數據，這可能會延遲該日期。

At the American Society for Clinical Oncology Meeting in June, we provided expanded analyses and presented data on new endpoints in key subgroups 4, KEYNOTE-716, for the adjuvant treatment in Stage IIb and IC melanoma, KEYNOTE-522 in neoadjuvant, adjuvant high-risk, early-stage triple-negative breast cancer and KEYNOTE-564 in adjuvant RCC.

在 6 月的美國臨床腫瘤學會會議上，我們提供了擴展分析並提供了關鍵亞組 4 中新終點的數據，KEYNOTE-716 用於 IIb 期和 IC 黑色素瘤的輔助治療，KEYNOTE-522 用於新輔助、輔助高風險、早期三陰性乳腺癌和輔助 RCC 中的 KEYNOTE-564。

We are also delivering on our regulatory strategy outside the United States. Notable actions include 4 approvals for KEYTRUDA from the European Commission based on KEYNOTE-716 for the adjuvant treatment of patients 12 years and older with completely resected Stage IIb or 2C melanoma; KEYNOTE-522 in high-risk early-stage triple-negative breast cancer; KEYNOTE-164 and KEYNOTE-158 in MSI high and/or mismatch repair deficient tumors in 5 different cancer types; and KEYNOTE-826 in certain types of persistent recurrent or metastatic cervical cancer.

我們還在美國以外地區實施我們的監管戰略。值得注意的行動包括 4 項歐盟委員會基於 KEYNOTE-716 批准 KEYTRUDA 用於輔助治療完全切除的 IIb 期或 2C 期黑色素瘤的 12 歲及以上患者； KEYNOTE-522在高危早期三陰性乳腺癌中； 5 種不同癌症類型中 MSI 高和/或錯配修復缺陷腫瘤中的 KEYNOTE-164 和 KEYNOTE-158；和 KEYNOTE-826 在某些類型的持續復發或轉移性宮頸癌中。

In addition, we received a positive EU CHMP opinion for adjuvant treatment with LYNPARZA for patients with serotypes of high-risk early-stage breast cancer based on the Phase III OlympiA trial. And finally, we are encouraged by the positive readout of KEYNOTE-869 or EV-103 and first-line urothelial cancer, which is in collaboration with Seagen.

此外，根據 III 期 OlympiA 試驗，我們收到了歐盟 CHMP 對 LYNPARZA 對血清型高危早期乳腺癌患者進行輔助治療的積極意見。最後，我們對與 Seagen 合作的 KEYNOTE-869 或 EV-103 和一線尿路上皮癌的陽性讀數感到鼓舞。

Next, I want to discuss our ongoing efforts to treat prostate cancer. Prostate cancer impacts millions of men and those with advanced disease have low rates of 5-year survival. We continue to generate insight about prostate cancer from our ongoing work, and we remain focused on improving patient outcomes. Business development and licensing remains a key element of our strategy to build and maintain a strong and diverse pipeline.

接下來，我想討論一下我們在治療前列腺癌方面的持續努力。前列腺癌影響著數百萬男性，晚期疾病患者的 5 年生存率較低。我們繼續從我們正在進行的工作中獲得有關前列腺癌的見解，並且我們仍然專注於改善患者的治療效果。業務開發和許可仍然是我們建立和維護強大而多樣化的管道戰略的關鍵要素。

Earlier this month, we announced a global development and commercial relation agreement with Orion for its investigational oral, steroid synthesis inhibitor, ODM-208, which is currently in Phase II development for the treatment of metastatic castrate-resistant prostate cancer.

本月早些時候，我們宣布與 Orion 就其研究性口服類固醇合成抑製劑 ODM-208達成全球開發和商業關係協議，該抑製劑目前處於 II 期開發階段，用於治療轉移性去勢抵抗性前列腺癌。

ODM-208 targets cytochrome P450 11A1, a novel approach that is complementary to our broad-based prostate cancer program, which includes the combination of KEYTRUDA with chemotherapy based on KEYNOTE-921, KEYTRUDA with antiandrogen therapy based on KEYNOTE-641 and KEYNOTE-991 and LYNPARZA with anti-androgen therapy based on the PROpel trial.

ODM-208 靶向細胞色素 P450 11A1，這是一種新方法，是對我們廣泛的前列腺癌計劃的補充，其中包括 KEYTRUDA 與基於 KEYNOTE-921 的化學療法的組合，KEYTRUDA 與基於 KEYNOTE-641 和 KEYNOTE-991 的抗雄激素療法的組合和 LYNPARZA 基於 PROpel 試驗的抗雄激素治療。

Next, to COVID-19 and LAGEVRIO. The pandemic persist and SARS-CoV-2 continues to evolve. There are solid emerging evidence for the threat of resistance to antibody therapies from Omicron variants, notably B4 and B5. The rate of transmission and increased hospitalizations with these variants reinforces the need for multiple effective antiviral treatment options, especially for those most vulnerable. For high-risk patients, evidence continues to show that prompt therapeutic intervention improved outcome.

接下來是 COVID-19 和 LAGEVRIO。大流行持續存在，SARS-CoV-2 繼續發展。有確鑿的新證據表明 Omicron 變體（尤其是 B4 和 B5）對抗體療法產生耐藥性的威脅。這些變體的傳播率和住院人數增加，強化了對多種有效抗病毒治療方案的需求，特別是對於那些最脆弱的人。對於高危患者，證據繼續表明及時的治療干預可以改善預後。

Importantly, a large proportion of high-risk individuals, including older adults, are likely receiving additional medications for chronic conditions. LAGEVRIO's low propensity for drug-drug interaction avoids the need to adjust existing dosing regimen and monitor liver and kidney functions during treatment, which can facilitate timely intervention for appropriate patients. Recently, data reported from Denmark, Hong Kong and Poland have provided support for the utility of LAGEVRIO in real-world settings. We plan to share more data as they become available.

重要的是，包括老年人在內的大部分高危人群可能正在接受額外的慢性病藥物治療。 LAGEVRIO 的低藥物相互作用傾向避免了在治療過程中調整現有給藥方案和監測肝腎功能的需要，這有助於對合適的患者進行及時干預。最近，來自丹麥、香港和波蘭的數據為 LAGEVRIO 在現實環境中的應用提供了支持。我們計劃在可用時共享更多數據。

To conclude, I am proud of the advancements across our pipeline to date and look forward to providing further updates on our scientific progress in the future.

最後，我為迄今為止我們的管道所取得的進展感到自豪，並期待在未來提供有關我們科學進展的進一步更新。

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. Alan, we're ready for the Q&A session. If you could please assemble the queue.

謝謝你，院長。 Alan，我們已經準備好進行問答環節了。如果可以，請集合隊列。

(Operator Instructions)

（操作員說明）

Our first question will come from Terence Flynn with Morgan Stanley.

我們的第一個問題將來自摩根士丹利的特倫斯弗林。

Maybe a 2-part one here. Just wondering if there's a pathway to extend the IP on KEYTRUDA via either a subcu formulation or maybe some other type of formulation patents? And then is there anything from a technical perspective that would prohibit a co-formulation of KEYTRUDA with an antibody drug conjugate?

也許這裡是兩部分。只是想知道是否有通過 subcu 配方或其他類型的配方專利擴展 KEYTRUDA 知識產權的途徑？那麼從技術角度來看，是否有任何事情會禁止 KEYTRUDA 與抗體藥物偶聯物的聯合製劑？

I guess I will take this. This is Dean. In relationship to different routes of administration, I think you've highlighted that, especially as we go into early stages of cancer, there will be a demand, demand by the patients and the providers to really come up with other formulations besides intravenous formulations where you have to go to an infusion center. So subcutaneous pembrolizumab could be very important to serve that need. And the innovation required for subcutaneous KEYTRUDA is viewed through the past history, and I would imagine the current situation is novel, useful and nonobvious. So I think there is a path to think about how to think about that innovation.

我想我會接受這個。這是迪恩。關於不同的給藥途徑，我認為您已經強調，尤其是當我們進入癌症的早期階段時，患者和提供者將需要真正提出除靜脈內製劑之外的其他製劑，其中你必須去輸液中心。因此，皮下 pembrolizumab 對於滿足這一需求可能非常重要。從過去的歷史來看，皮下 KEYTRUDA 所需的創新，我想現在的情況是新穎的、有用的和不明顯的。所以我認為有一條途徑可以思考如何思考這種創新。

In relationship to co-formulations. In general, co-formulations work well with, for example, when we do IO-IO with PD-1, then CTLA-4, TIGIT or LAG-3. The issue with chemo-based or antibody drug conjugate basis, I would be a little bit hesitant to do that. Oftentimes, they're based on weight base, and so I think that co-formulations of, for example, any IO agent with any chemotherapy or antibody drug conjugates could be challenging to take that clinically.

與復合製劑有關。一般而言，聯合製劑適用於例如，當我們使用 PD-1、CTLA-4、TIGIT 或 LAG-3 進行 IO-IO 時。基於化學或抗體藥物偶聯物的問題，我會有點猶豫。通常，它們基於重量基礎，因此我認為，例如，任何 IO 藥物與任何化學療法或抗體藥物偶聯物的聯合製劑在臨床上可能具有挑戰性。

That will be from Evan Seigerman with BMO Capital Markets.

這將來自 BMO Capital Markets 的 Evan Seigerman。

So with the widespread news reports of a potential deal with Senators management and Schumer, can you provide us with your thoughts on kind of the structure for Medicare to directly negotiate with manufacturers for drug reimbursement and the potential impact on R&D going forward?

因此，隨著與參議員管理層和舒默潛在交易的廣泛新聞報導，您能否向我們提供您對醫療保險直接與製造商就藥物報銷進行談判的結構以及對未來研發的潛在影響的看法？

Yes. Evan, thanks for the question. This is Rob. As you said, there is reports out, really it just came out yesterday, of a potential deal with Senator Schumer and mentioned in that is elements of what have been part of the Build Back Better Plan related to drug pricing. So as we look at that, I think it's important to understand, first and foremost, we do have significant concern on one very important element of the provision, which is the fact that there is what we see as price setting, it's termed in negotiation. But in effect, what it is, it is price setting on drugs after a period of time.

是的。埃文，謝謝你的問題。這是羅布。正如你所說，有報導稱，實際上是昨天才公佈的，與參議員舒默達成的潛在交易，其中提到的是與藥品定價相關的“重建更好計劃”的一部分。因此，當我們看到這一點時，我認為重要的是首先要理解，我們確實對該條款的一個非常重要的要素非常關注，那就是我們認為價格設定的事實，它在談判中被稱為.但實際上，它是一段時間後對藥品的定價。

And we do believe that will be highly chilling on future innovation because, especially if you think about an area like oncology, oncology is an area that the development of the drug continues long after the first approval. If you take KEYTRUDA, that launched in 2014, between 2014 and 2022, we had something like 30-plus indications approved. We expect to have well more than double that between 2022 and 2028.

而且我們確實相信這將對未來的創新產生極大的影響，因為，特別是如果你考慮像腫瘤學這樣的領域，腫瘤學是一個藥物開發在首次獲批後持續很長時間的領域。如果您採用 2014 年推出的 KEYTRUDA，在 2014 年至 2022 年之間，我們已經批准了大約 30 多個適應症。我們預計，在 2022 年至 2028 年期間，這一數字將翻倍以上。

And our concern is that if you start to have the threat of discounts, mandatory discounts it could cause companies to question that innovation because you'll have to question whether or not you're going to see the return. So we see a higher chilling effect of that, and it's something that we will continue both at Merck as the industry to make sure that we communicate our concerns there.

我們擔心的是，如果您開始受到折扣的威脅，強制性折扣可能會導致公司質疑這種創新，因為您將不得不質疑您是否會看到回報。因此，我們看到了更高的寒蟬效應，我們將在默克作為整個行業繼續這樣做，以確保我們在那里傳達我們的擔憂。

And the only other thing I might add is, as you think about how we think about this to our business going forward. It's important to understand that as we look at this, while obviously, it will have an impact, importantly, as we've planned for the future of the business, we have always assumed some form of price pressure coming, including in the United States. I think we've communicated that in the past. So as we look at this, and you think of a relative to the guidance we've given in the past of expectations for strong growth through our long-range period. That continues and includes the assumptions around this. So while I think we will manage it, I do worry about what it will do to innovation in the industry.

我可能要補充的唯一另一件事是，當您考慮我們如何看待這對我們未來的業務的看法時。重要的是要理解，當我們看到這一點時，雖然很明顯，它會產生影響，重要的是，正如我們為業務的未來所做的計劃一樣，我們總是假設某種形式的價格壓力即將到來，包括在美國.我想我們過去已經溝通過。因此，當我們看到這一點時，您會想到與我們過去給出的指導相關的，即我們對長期強勁增長的預期。這繼續並包括圍繞此的假設。因此，雖然我認為我們會管理它，但我確實擔心它會對行業創新產生什麼影響。

Will come from Andrew Baum with Citi.

將來自花旗銀行的安德魯鮑姆。

A couple of questions. Firstly, you've announced a couple of licensing from China of ADCs. I think one of them is in late-stage development. It's obviously widely reported that you're in talks with Seagen, which has Phase III data from another ADC molecule, which would compete with HER2. In general, I'm just interested, Dr. Pastor seems to have closed the doors on seeking approval in the U.S. using data from Chinese trials. But operationally, how fast does it enable you to go, knowing that you have efficacy and safety signals in a Chinese population in expediting the move into Phase III i.e., is there an advantage here that could enable you to catch up with the market leaders in those respective categories?

幾個問題。首先，你們宣布了一些來自中國的 ADC 許可。我認為其中之一處於後期開發階段。顯然，廣泛報導說您正在與 Seagen 進行談判，該公司擁有來自另一個 ADC 分子的 III 期數據，該分子將與 HER2競爭。總的來說，我只是感興趣，Pastor 博士似乎已經關閉了使用中國試驗數據在美國尋求批准的大門。但是在操作上，它能讓你走多快，知道你在中國人群中有有效和安全的信號來加速進入第三階段，也就是說，這裡是否有一個優勢可以讓你趕上市場領導者那些各自的類別？

And then second question on islatravir, perhaps you care to update us how are your discussions with Gilead in terms of -- and the FDA in terms of resuming trials. Is this drug alive as a prophylactic, in PrEP as a treatment, both or neither?

然後是關於 islatravir 的第二個問題，也許您想告訴我們您與吉利德（Gilead）和 FDA 在恢復試驗方面的討論如何。這種藥物是作為預防劑，在 PrEP 中作為治療劑，兩者兼而有之，還是兩者都沒有？

So this is Dean. Thank you very much for those questions. To tackle your first question related to our recently announced partnership with Kelun. I should just emphasize this was recently announced, but we've had a productive, a really productive partnership for the past 2 years. And most recently, they have announced progress in 2 programs. One that they've declared, which relates to TROP2-ADCs, and they're advancing it in China in relationship with breast cancer and non-small cell lung cancer.

這就是迪恩。非常感謝您提出這些問題。為了解決您與我們最近宣布的與科倫合作的第一個問題。我應該強調這是最近宣布的，但在過去的 2 年裡，我們建立了富有成效的、真正富有成效的合作夥伴關係。最近，他們宣布了 2 個項目的進展。他們宣布的一項與 TROP2-ADC 相關，他們正在中國推進與乳腺癌和非小細胞肺癌的關係。

In relationship to what you've said in -- of moving those molecules, for example, in the United States, I think the FDA and we support this. The FDA has been very clear of the importance of doing those trials, not in a single geography such as China, but to have global studies that include the United States. And so the ability for our partners to give us a signal in a human population is really important and allows us to navigate how to think about it at a global level. And so we are hopeful that this partnership will allow us to accelerate the benefits of this TROP2-ADC to as many patients as possible.

關於你所說的移動這些分子，例如，在美國，我認為 FDA 和我們支持這一點。 FDA 非常清楚進行這些試驗的重要性，不是在中國這樣的單一地區進行，而是在包括美國在內的全球範圍內開展研究。因此，我們的合作夥伴能夠在人類群體中向我們發出信號的能力非常重要，它使我們能夠在全球範圍內導航如何思考它。因此，我們希望這種夥伴關係將使我們能夠加速這種 TROP2-ADC 對盡可能多的患者的益處。

To your second question in relationship to islatravir. As you've noticed, islatravir is our NRTTI. It's extremely potent that has a resident time in tissue and has a high barrier to resistance. And we had 2 Phase III studies that have excellent results. Nevertheless, we also had reduction in lymphocytes across a number of our programs, most of it asymptomatic, but in a combo trial with MK-8507, there was clinically meaningful reduction that's still dependent. We have spent the last 6 months understanding that. We understand it far better. We believe that there is a potential path forward to maintain and to have that efficacy and also reduce the effects on the live blood cells. We are in active discussions with the FDA. So I don't want to get ahead of myself there, and we clearly have active discussions with our partners.

關於您與伊拉曲韋有關的第二個問題。正如您所注意到的，islatravir 是我們的 NRTTI。它非常有效，在組織中具有駐留時間，並且具有很高的抗藥性。我們有 2 項 III 期研究取得了很好的結果。儘管如此，在我們的一些項目中，淋巴細胞也有所減少，其中大部分是無症狀的，但在與 MK-8507 的組合試驗中，仍有臨床意義的減少，這仍然是依賴的。在過去的 6 個月裡，我們一直在理解這一點。我們對它的理解要好得多。我們相信，有一條潛在的道路可以維持並具有這種功效，並減少對活血細胞的影響。我們正在與 FDA 進行積極的討論。所以我不想在那裡超越自己，我們顯然與我們的合作夥伴進行了積極的討論。

In relationship to the question of treatment and PrEP, I just want to make sure that everyone recognizes we have always thought that this class of molecules NRTTI and islatravir is just one compound within this class, could be broadly used in treatment and in PrEP, and we are interested in applying both of those -- advancing both of those possibilities, but we are in the midst of discussions with the FDA that I think we should provide them the data that they will need.

關於治療和 PrEP 的問題，我只想確保每個人都認識到我們一直認為 NRTTI 和 islatravir 這類分子只是這一類中的一種化合物，可以廣泛用於治療和 PrEP，並且我們有興趣應用這兩種方法——推進這兩種可能性，但我們正在與 FDA 進行討論，我認為我們應該向他們提供他們需要的數據。

That will be Louise Chen with Cantor.

那將是與 Cantor 一起的 Louise Chen。

So I wanted to ask you about the checkpoint inhibitor strategy. What are your thoughts on the changing treatment paradigm for checkpoint inhibitors in the neoadjuvant and adjuvant cancer setting. How do you think about adoption and uptake in this setting? And do you think doctors are convinced of the opportunity yet? Or is there more work to be done?

所以我想問你關於檢查點抑製劑策略的問題。您對檢查點抑製劑在新輔助和輔助癌症環境中不斷變化的治療模式有何看法？您如何看待在這種情況下的採用和吸收？你認為醫生們對這個機會深信不疑嗎？還是有更多的工作要做？

Well, let me answer it from a scientific standpoint. Maybe we'll have Caroline or Rob answer it from a market standpoint. I do think it's really important to just highlight, at least for me, PD-1s have been incredible in metastatic through a broad range of tumor types. And we keep going in for earlier stages. And it's not top priority that a medicine that works in the metastatic patient who has a very different benefit/risk ratio will be truly effective in the early stage. And it's been impressive. We have 6 approvals, whether it be in breast, in renal cell carcinoma and melanoma. And we have a positive trial in relationship to lung, and we have many others advancing.

好吧，讓我從科學的角度來回答。也許我們會讓 Caroline 或 Rob 從市場的角度來回答這個問題。我確實認為重要的是要強調，至少對我而言，PD-1 在通過廣泛的腫瘤類型轉移方面的表現令人難以置信。我們繼續進入早期階段。而且，一種對具有非常不同的收益/風險比的轉移性患者有效的藥物在早期階段是否真正有效並不是首要任務。它令人印象深刻。我們有 6 項批准，無論是在乳腺、腎細胞癌和黑色素瘤中。我們在與肺有關的方面進行了積極的試驗，我們還有許多其他方面的進展。

So I think that part of it is -- I think the uptake has been good, but the most important thing is that scientifically, the data has been very good. And I think the field will adopt it. I think one of the things that will be critical as the field adopts it is that oftentimes, you're now talking not necessarily about a medical oncologist. So there will be work for us to do, but I think the results speak for themselves. And I would recommend that people look at that data, and I think that it's an important advancement in the field. But in terms of the uptake, Caroline, do you want to take care of that?

所以我認為這部分是 - 我認為吸收很好，但最重要的是，從科學上講，數據非常好。我認為該領域會採用它。我認為隨著該領域的採用，其中一件至關重要的事情是，您現在談論的不一定是醫學腫瘤學家。所以我們會有工作要做，但我認為結果不言自明。我建議人們查看這些數據，我認為這是該領域的一項重要進步。但就吸收而言，卡羅琳，你想解決這個問題嗎？

Yes. Thank you, Dean. So Louise, we are really excited about the opportunities that we have moving into earlier stages of cancer. Clearly, if we can impact patients then, the possibilities of better outcomes are greater. We have seen in our early-stage cancers, impressive performance. We're seeing very strong performance in triple-negative breast cancer, renal cell carcinoma and melanoma. And if I just touch on triple-negative breast cancer, we had the KEYNOTE-522 approval here in the United States July of last year.

是的。謝謝你，院長。所以路易絲，我們對進入癌症早期階段的機會感到非常興奮。顯然，如果我們能夠影響患者，那麼獲得更好結果的可能性就更大。我們已經在我們的早期癌症中看到了令人印象深刻的表現。我們在三陰性乳腺癌、腎細胞癌和黑色素瘤中看到了非常強勁的表現。如果我只談三陰性乳腺癌，去年 7 月我們在美國獲得了 KEYNOTE-522 的批准。

During the second part of last year, we saw tremendous uptake in the first segment of treatment, the neoadjuvant treatment ahead of people then getting their surgery some 24 weeks later. What we're now seeing is not only patients coming on to KEYTRUDA for neoadjuvent triple-negative breast cancer, we're also seeing them return to treatment following their surgery. So we're very optimistic about the opportunities we have in the adjuvant setting and the impact that we can have on patients.

在去年下半年，我們看到第一階段治療的大量使用，即新輔助治療先於人們，然後在大約 24 週後進行手術。我們現在看到的不僅是患者接受 KEYTRUDA 治療新輔助三陰性乳腺癌，我們還看到他們在手術後恢復治療。因此，我們對我們在輔助治療中的機會以及我們可以對患者產生的影響非常樂觀。

We will go to Umer Raffat with Evercore.

我們將和 Evercore 一起去 Umer Raffat。

I have 2 here, if I may. First, Rob, I know you've mentioned M&A is critical to further diversification of the business away from KEYTRUDA. And you could explore M&A in -- basically in a non-oncology bucket like Acceleron or in oncology. And I guess that brings me to my first question, which is in oncology, it's a very high-quality problem of KEYTRUDA being this foundational treatment across so many different tumors. And how do you approach that given the increased FTC focus on looking at a lot of deals based on market shares on individual markets, considering KEYTRUDA basically has a market share in so many different tumors. And how do you think about oncology deals in general given KEYTRUDA's roll in. I'm sure you guys have thought about that at length to the extent you're thinking about any capital deployment.

如果可以的話，我這裡有 2 個。首先，Rob，我知道您提到併購對於進一步實現 KEYTRUDA 之外的業務多元化至關重要。你可以探索併購——基本上是在像 Acceleron 這樣的非腫瘤學領域或腫瘤學領域。我想這讓我想到了我的第一個問題，那就是腫瘤學，這是 KEYTRUDA 的一個非常高質量的問題，它是跨越這麼多不同腫瘤的基礎治療。考慮到 KEYTRUDA 基本上在這麼多不同的腫瘤中擁有市場份額，鑑於 FTC 越來越關注基於單個市場的市場份額來查看大量交易，你如何處理這個問題。鑑於 KEYTRUDA 的加入，您如何看待一般的腫瘤學交易。我相信你們在考慮任何資本部署時已經詳細考慮了這一點。

Separately, Rob, also, you mentioned drug pricing and mandatory discounts. And I'm sure you've run exercises internally attempting to quantify how much in discounts. And what I'm getting at is for key franchises like KEYTRUDA, considering the price of U.S. and ex-U.S. is fairly comparable, wouldn't there be not much mandatory discount at all? I just want to make sure I'm not off track there despite KEYTRUDA being a top Part B drug.

另外，Rob，您還提到了藥品定價和強制性折扣。而且我敢肯定，您已經在內部進行了練習，試圖量化折扣的多少。考慮到美國和前美國的價格，我得到的是像 KEYTRUDA 這樣的關鍵特許經營權。相當可比，不會有沒有太多的強制性折扣嗎？我只是想確保我沒有偏離軌道，儘管 KEYTRUDA 是 B 部分的頂級藥物。

Yes. I appreciate the questions. And on your first question around the M&A space and what we see in the oncology field. No, I would just start by saying, obviously, we are very proud of the success we've had with KEYTRUDA and the fact that it's been able to impact so many people's lives, as you say, across so many different tumor types. But I think it's important to understand that oncology continues to be an incredibly competitive field, and importantly, it's not monolithic. You have to look tumor by tumor and even modalities, whether it's IO or targeted therapy. So there are multiple different approaches, multiple modalities and it is a very tumor specific. And as you know, we have to develop these drugs indication by indication of investing in the science to bring each of those forward.

是的。我很欣賞這些問題。關於併購領域以及我們在腫瘤學領域看到的第一個問題。不，我首先要說的是，顯然，我們為 KEYTRUDA 取得的成功以及它能夠影響這麼多人的生活這一事實感到非常自豪，正如你所說，跨越這麼多不同的腫瘤類型。但我認為重要的是要了解腫瘤學仍然是一個極具競爭力的領域，而且重要的是，它不是單一的。無論是 IO 還是靶向治療，您都必須逐個腫瘤甚至治療方式來觀察腫瘤。因此，有多種不同的方法、多種方式，而且它是一種非常具有腫瘤特異性的方法。如你所知，我們必須通過投資科學來開發這些藥物的適應症，以推動每一種藥物的發展。

And in that regard, as we look at it and as we thought about it, we continue to believe that while the environment is more complex. And obviously, we'll have to be very thoughtful on how we navigate it, I believe, we believe, as long as we are doing deals that are science-driven, where we accelerate innovation, and we can show that we can expand access to patients around the world and in the United States to medicines that there are still deals to be done and that there's a path to move forward.

在這方面，當我們審視它並思考它時，我們仍然相信，雖然環境更加複雜。顯然，我們必須對如何駕馭它非常深思熟慮，我相信，我們相信，只要我們進行科學驅動的交易，我們可以加速創新，並且我們可以證明我們可以擴大訪問向世界各地和美國的患者提供藥物，這些藥物仍有待完成，並且有前進的道路。

And so that's very much where we're focusing and why we continue to believe the opportunity exists to continue to expand treatments for patients and for the benefit of, frankly, all stakeholders, including shareholders.

因此，這正是我們關注的重點，也是為什麼我們繼續相信存在繼續擴大對患者的治療的機會，坦率地說，這將造福於包括股東在內的所有利益相關者。

On your second question, and I think it depends on the way you look at it, as far as the upcoming regulation. Obviously, if you look across what is being proposed, if you're speaking specifically to the potential for mandatory price discounting at some point. Obviously, the language has to be finalized. But if you look at where it is today, the way it is being proposed is that for a period of time after a drug is approved during its period of exclusivity for -- right now, it's roughly 7 years for negotiation for slow molecules, 11 years for large molecules, you were able to operate with no discount.

關於你的第二個問題，我認為這取決於你看待它的方式，就即將出台的法規而言。顯然，如果您查看所提議的內容，如果您專門談到在某個時候強制價格折扣的可能性。顯然，語言必須最終確定。但如果你看看它今天的位置，它被提議的方式是，在一種藥物在其排他性期間獲得批准後的一段時間內——現在，慢分子的談判大約需要 7 年，11對於大分子，您可以毫無折扣地進行操作。

At that period of time, there would be a discussion and opportunity for HSS to select the drug depending on their determination of which drugs to look at. Right now as the language is discussed, we'll pick 10 drugs a year and up to the HSS to determine which drug they'd pick. But importantly, then the negotiation itself once it is done and the discount is determined and that discount is outlined in the legislation would take effect at year 9 for a small molecule, year 13 for a large molecule.

在那段時間，HSS 將有討論和機會來選擇藥物，這取決於他們決定要查看哪些藥物。現在討論語言時，我們將每年挑選 10 種藥物，並由 HSS 決定他們會選擇哪種藥物。但重要的是，一旦談判完成並確定折扣並且立法中概述的折扣將在小分子的第 9 年生效，大分子的第 13 年生效。

So as you think of something like KEYTRUDA, we're really talking about periods of time that are out around the time of loss of exclusivity in 2028. And obviously, there's other language that's being proposed potentially to allow for an exception if there are biosimilar products in development coming that then you would not be subject to it.

因此，當您想到 KEYTRUDA 之類的東西時，我們實際上是在談論 2028 年失去排他性的時間段。顯然，如果有生物仿製藥，還有其他語言可能允許例外正在開發的產品即將推出，那麼您將不會受到它的影響。

So the reality of it is it's unclear what the impact will be, in the short term, we don't see impacts from that specific part of the regulation. It will be longer term as it relates to our important drugs, KEYTRUDA and GARDASIL. And then obviously, we have to see how the final language comes out. But in the language there will then be specified discounts that will be set. So it's not reference price in the way they're setting it up right now.

因此，現實情況是，目前尚不清楚會產生什麼影響，在短期內，我們看不到法規中特定部分的影響。這將是長期的，因為它與我們的重要藥物 KEYTRUDA 和 GARDASIL 有關。然後很明顯，我們必須看看最終的語言是如何產生的。但是在該語言中，將設置指定的折扣。所以這不是他們現在設置的參考價格。

And then obviously, beyond that, there is what they have around the Part B reforms, which actually what we support because we believe that will reduce the out-of-pocket costs for patients at the counter, but our -- the reason we continue to oppose the overall legislation is a strong belief that, that focus on mandatory discounts after a period of time is chilling to innovation. So I'm not sure I got your question, but I think that's what you were trying to get at.

然後很明顯，除此之外，他們在 B 部分改革中有什麼，這實際上是我們支持的，因為我們相信這將減少櫃檯患者的自付費用，但是我們 - 我們繼續的原因反對整體立法的堅定信念是，在一段時間後專注於強制性折扣是對創新的寒蟬。所以我不確定我是否得到了你的問題，但我認為這就是你想要解決的問題。

That will be from Geoff Meacham with Bank of America.

這將來自美國銀行的 Geoff Meacham。

I just had a couple of quick ones. Dean, I wanted to ask you on KEYNOTE-412, the recent -- it didn't hit significance. Did CRT add complexity to the study in terms of your assumptions? And more broadly, if you look at other indications, does a CRT backbone present any particular challenges when you look at other keynote studies? And then on COVID, the recent infection trends just over the course of this year or the emergence of any new variants, does that change the strategy about the future investments you guys are going to make in LAGEVRIO or even other orals?

我只是有幾個快速的。院長，我想在最近的 KEYNOTE-412 上問你——它沒有意義。根據您的假設，CRT 是否增加了研究的複雜性？更廣泛地說，如果您查看其他跡象，當您查看其他主題研究時，CRT 主幹是否存在任何特殊挑戰？然後在 COVID 方面，今年最近的感染趨勢或任何新變種的出現，是否會改變你們未來對 LAGEVRIO 甚至其他口服藥物的投資策略？

All right. I'll take both of them, I'll take the Keynote-412. So you're speaking about the -- us trying to go in for early stage at a neck and you're speaking about that 412, which, as you've emphasized, there was improvement in event-free survival for patients who received the KEYTRUDA regimen compared to the placebo plus CRT.

好的。我會拿他們兩個，我會拿 Keynote-412。所以你說的是——我們試圖進入早期階段，你說的是 412，正如你所強調的，接受KEYTRUDA 方案與安慰劑加 CRT 相比。

However, these results did not meet statistical significance based on our pre (inaudible) statistical plan. So there's clearly a positive signal, but it did cross the line. In relationship to -- how to think about CRT or radiation and other indications in this. I would not say that it gives you extra complication. We'll have to see in these other trials when -- not just us but other people in relationship to the combination there.

然而，根據我們的預（聽不清）統計計劃，這些結果不符合統計意義。所以顯然有一個積極的信號，但它確實越界了。關於——如何考慮 CRT 或輻射和其他適應症。我不會說它會給您帶來額外的複雜性。我們將不得不在這些其他試驗中看到——不僅是我們，還有其他與那裡的組合有關的人。

But I would just emphasize that it was an improvement in EFS. So I wouldn't say that it was a complicating issue for us. We just did need statistical significance. I do want to make sure that everyone recognizes that this isn't our only foray into head and neck early stage. We have a KEYNOTE-689 that's also in the neoadjuvant and adjuvant treatment as well. So we're cautiously optimistic that we can break into early stage at a neck despite the fact that KEYNOTE-412, it had a positive EFS did not lead to statistical significance.

但我只想強調這是對 EFS 的改進。所以我不會說這對我們來說是一個複雜的問題。我們只是需要統計顯著性。我確實想確保每個人都認識到這不是我們進入頭頸部早期階段的唯一嚐試。我們有一個 KEYNOTE-689，它也用於新輔助和輔助治療。因此，我們謹慎樂觀地認為，儘管 KEYNOTE-412 具有積極的 EFS 並沒有導致統計顯著性，但我們可以進入早期階段。

In relationship to the pandemic, I need to be a little bit careful because everyone who's predicted what will happen with the pandemic have all had one common thread. They've all been not so right. And so we'll have to see what happens with the pandemic. We'll have to see what the emergence of resistance is, but I would emphasize the importance of having multiple mechanisms of action is clear. I would just emphasize that it is quite surprising to me how quickly this virus can mutate around those therapies, for example, focused on this like protein. That's actually it takes many amino-acid changes to do it. And it might take very few amino acids changes to get resistance to, for example, other therapies, but we'll have to see what it is.

關於大流行，我需要小心一點，因為每個預測大流行會發生什麼的人都有一個共同點。他們都不太對勁。因此，我們將不得不看看大流行會發生什麼。我們必須看看耐藥性的出現是什麼，但我要強調的是，具有多種作用機制的重要性是顯而易見的。我只想強調一下，這種病毒能以多快的速度在這些療法周圍發生變異，這讓我感到非常驚訝，例如，專注於這種類似蛋白質的療法。這實際上需要許多氨基酸變化才能做到這一點。可能只需要很少的氨基酸變化就能對其他療法產生抗藥性，但我們必須看看它是什麼。

But I just want to also emphasize that, especially outside of the United States, there's been a great use of it and uptake, and it's really based on the fact that if you have a patient population where you believe that they're extremely vulnerable and you can give this drug and you're most interested in reducing mortality, which this drug has an impressive impact on mortality and you want speed such that you can really see the patient and who may be on multiple medicines, have other complicating medical issues and feel free that you can give this, if those are the important sort of attributes then we have found that LAGEVRIO does quite well and the real-world evidence throughout the world has begun to substantiate.

但我只想強調一點，尤其是在美國以外，它的使用和吸收量很大，而且它確實基於這樣一個事實，即如果您有一個患者群體，您認為他們非常脆弱並且您可以給予這種藥物，並且您最感興趣的是降低死亡率，這種藥物對死亡率的影響令人印象深刻，您希望速度能夠真正看到患者，他們可能正在服用多種藥物，還有其他復雜的醫療問題和隨意你可以給出這個，如果這些是重要的屬性，那麼我們發現 LAGEVRIO 做得很好，全世界的真實世界的證據已經開始證實。

And Jeff, this is Caroline. The only thing I would add in terms of further investments is our belief in the molecule as being a molecule monotherapy as seeing a molecule that could be impactful, not only against COVID-19, but also pan-coronavirus, RSV and flu. And as a result, we will invest in appropriate programs to try and prove that out.

傑夫，這是卡羅琳。在進一步投資方面，我唯一要補充的是，我們相信該分子是一種分子單一療法，因為看到了一種可能有影響的分子，不僅對 COVID-19，而且對泛冠狀病毒、RSV 和流感也有影響。因此，我們將投資於適當的計劃來嘗試證明這一點。

That will be from Mara Goldstein with Mizuho.

那將來自 Mara Goldstein 和瑞穗。

Firstly, I just wanted to understand the statement about KEYTRUDA supplemental PDUFA for adjuvant non-small cell lung cancer? And have you been asked for additional data? Or are you planning for a major amendment?

首先，我只是想了解一下關於 KEYTRUDA 補充 PDUFA 用於輔助非小細胞肺癌的說法？您是否被要求提供其他數據？或者您是否計劃進行重大修改？

And then secondarily, I just wanted to also get some clarity on the comment about excess cash for share repurchase. And at what threshold should we be thinking about that if you're also committed to raising dividend?

其次，我只是想澄清一下關於股票回購的多餘現金的評論。如果你也致力於提高股息，我們應該在什麼門檻上考慮這一點？

Yes. So I'll -- this is Dean. I'll take the KEYNOTE-091, 0-9-1, so that's the lung adjuvant. And just to remind everyone, that had dual primary endpoints. And the reason I want to emphasize that the dual primary means that if you hit on one of the endpoints, you have a positive trial. And this is a distinction from those trials that are co-primary where you have to hit on both. So this is a positive trial because in the disease-free survival, it's positive in all comers regardless of PD-L1.

是的。所以我會 - 這是Dean。我會服用 KEYNOTE-091，0-9-1，這是肺佐劑。只是提醒大家，這有兩個主要終點。我要強調的原因是雙重主要意味著如果您達到其中一個端點，您就會獲得積極的試驗。這與那些你必須同時進行的共同主要試驗的區別。所以這是一個積極的試驗，因為在無病生存中，無論 PD-L1 是什麼，所有參與者都是積極的。

Our -- the dual primary of DFS in terms of those with a TPS greater than 50%, there is a positive trend, but it's not significant. And the OS has got a (inaudible) trend as we move forward. I would imagine, as data matures people may want to see those data, and I just want to emphasize that in relationship to early-stage lung cancer, we have other trials as well, which is KEYNOTE-671, KEYNOTE-867 and KEYLYNK-012.

我們的 DFS 的雙主，就 TPS 大於 50% 的人而言，有一個積極的趨勢，但並不顯著。隨著我們向前發展，操作系統出現了（聽不清）趨勢。我想，隨著數據的成熟，人們可能希望看到這些數據，我只想強調，與早期肺癌有關，我們還有其他試驗，即 KEYNOTE-671、KEYNOTE-867 和 KEYLYNK- 012.

So I could imagine that as people deliberate on this, they will be interested in understanding how the data is maturing. These are event-driven and they're part of our FDA discussions and the PDUFA date, as you've said, is January 29, 2023. But we could see a situation. There's nothing formally that's been asked of us, but we could see a situation where evolving data is asked for.

所以我可以想像，當人們對此進行深思熟慮時，他們會對了解數據如何成熟感興趣。這些是事件驅動的，它們是我們 FDA 討論的一部分，正如你所說，PDUFA 日期是 2023 年 1 月 29 日。但我們可以看到一種情況。我們沒有正式提出任何要求，但我們可以看到要求不斷變化的數據的情況。

And Mara, in response to your question on our utilization of excess cash, the capital allocation priorities of our company are unchanged. We continue to invest first and foremost in our business and the great opportunities that are in front of us. Business development is a strategic priority for us, and we will invest in business development as we have done in the past.

瑪拉，在回答你關於我們使用多餘現金的問題時，我們公司的資本配置優先級沒有改變。我們將繼續首先投資於我們的業務和擺在我們面前的巨大機遇。業務發展是我們的戰略重點，我們將像過去一樣投資於業務發展。

We intend to continue to raise our dividend over time and we will then return any excess cash to our shareholders via share buyback. We do not intend to sit with multiple capacity on our balance sheet for periods of time and not use that cash in this regard. So I hope that addresses the use of our cash.

我們打算隨著時間的推移繼續提高我們的股息，然後我們將通過股票回購將任何多餘的現金返還給我們的股東。我們不打算在一段時間內在我們的資產負債表上擁有多種能力，也不打算在這方面使用這些現金。所以我希望解決我們現金的使用問題。

It will be from Seamus Fernandez with Guggenheim.

它將來自古根海姆的 Seamus Fernandez。

So maybe just one M&A question. Can you just clarify whether any acquisition plans or that Merck will consider is likely to be all cash or if there would be a potential use of equity that would be or could be considered in a potential transaction.

所以也許只是一個併購問題。您能否澄清一下，默克公司將考慮的任何收購計劃是否可能全部為現金，或者是否會在潛在交易中考慮或可能考慮使用股權。

And then separately, just wanted to get a little bit of the vision for V116? And where and how you see V116 competing in the overall market? Are we really just looking at that as a potential opportunity solely for adults? Or do you envision the '21 balance actually being a high-use target opportunity in the pediatric patient population as well. And then just trying to get a sense of timing of when we could see V116 actually competing in market and how you see the overall market evolving over time?

然後分別，只是想了解一點 V116 的願景？您如何看待 V116 在整個市場中的競爭？我們真的只是將其視為成年人的潛在機會嗎？或者您是否設想 '21 平衡實際上也是兒科患者群體中的一個高使用目標機會。然後只是想了解我們何時可以看到 V116 真正在市場上競爭，以及您如何看待整個市場隨著時間的推移而發展？

Yes. Thanks, Seamus, for the question. Obviously, business development remains a priority for us, as we've discussed. And importantly, we look to add wherever we can find the best science and innovations that enhance our pipeline and drive long-term growth and value for shareholders. I don't want to speculate on specific future transactions or the specific combination of cash or equity we would use because it really would be fact specific to the deal at hand. And so in that sense, I think we'd have to wait.

是的。謝謝，Seamus，提出這個問題。顯然，正如我們所討論的，業務發展仍然是我們的首要任務。重要的是，我們希望在我們能找到最好的科學和創新的地方添加，以增強我們的管道並推動股東的長期增長和價值。我不想推測特定的未來交易或我們將使用的現金或股權的特定組合，因為它確實是針對手頭交易的事實。所以從這個意義上說，我認為我們必須等待。

The broader point, I think, that I want to enforce and we've said consistently is we have the capital and the balance sheet strength to go after anything that we feel is strategically important that brings that scientific innovation that I mentioned that will allow us to continue to augment what we have in our own internal pipeline. So we have the capacity and the flexibility to structure it, how we see best to optimize the business, how you do that between cash, debt and equity is really deal-specific.

我認為，更廣泛的一點是，我想要執行並且我們一直在說的是，我們有資本和資產負債表實力去追求任何我們認為具有戰略重要性的東西，它會帶來我提到的科學創新，這將使我們能夠繼續擴大我們自己內部管道中的內容。因此，我們有能力和靈活性來構建它，我們認為如何最好地優化業務，你如何在現金、債務和股權之間做到這一點確實是特定於交易的。

Yes, in relationship to the questions that you had about V116, I just want to reiterate or reemphasize the strategy that we think, which is in different age groups or different populations, the serotypes that are most troublesome for different populations is very different. So the whole focus of V116, the whole focus of the V116 is to recognize the serotypes that are specifically important for adults and to target that. And that's what V116 is, and that's why we had the first of 4 current Phase III trials that have to run its course.

是的，關於你關於V116的問題，我只想重申或再次強調我們認為的策略，即在不同的年齡組或不同的人群中，對不同人群來說最麻煩的血清型是非常不同的。所以 V116 的全部重點，V116 的全部重點是識別對成人特別重要的血清型並針對它。這就是 V116 的意義所在，這就是為什麼我們要進行 4 項當前 III 期試驗中的第一項，這些試驗必須順利進行。

There is not a view from my standpoint, scientifically, that this is a vaccine that I would drive into the pediatric population because the epidemiology as of right now would suggest that, that would not be the right place to put this vaccines. We want to put the vaccines where the serotypes match what is happening to that patient population.

從我的角度來看，從科學的角度來看，我不認為這是一種我會在兒科人群中使用的疫苗，因為目前的流行病學表明，那不是放置這種疫苗的正確位置。我們希望將疫苗放在血清型與該患者群體發生的情況相匹配的地方。

Yes. I might just add to that. If you look at it as we think about the future commercially, we see a real opportunity when you think about this bespoke approach where you have actions that we think will be highly effective in combating the serotypes that cause disease in infants and children as our pediatric approach. And then you have a separate approach with V116 aimed at the adult market.

是的。我可能會補充一點。如果您從我們對商業未來的思考中看待它，當您考慮這種定制方法時，我們看到了一個真正的機會，我們認為您採取的行動將非常有效地對抗導致嬰兒和兒童疾病的血清型作為我們的兒科方法。然後你有一個針對成人市場的 V116 的單獨方法。

We will go after 85% of the residual disease, understanding that if you've treated it in children, you obviously have a different set of serotypes that are driving it in adults. And we are focusing on both of those as bespoke therapies aimed to what is most aligned with the needs in those populations.

我們將追踪 85% 的殘留疾病，了解如果您在兒童中治療過，您顯然有一組不同的血清型在成人中驅動它。我們專注於將這兩種療法作為定制療法，旨在最符合這些人群的需求。

I think this will be highly effective and will allow us to be very competitive, in fact, cover more than what the competitor products cover in the disease-causing serotypes than you see today either in what they have in both the pediatric and adult market.

我認為這將非常有效，並使我們具有很強的競爭力，事實上，在致病血清型中所涵蓋的競爭對手產品所涵蓋的範圍比您今天在兒科和成人市場中所看到的要多。

So I think this is something we're very excited about. And in fact, we see V116 as really bringing to fruition that strategy. So we're excited about it. And we're going to drive it with speed because I do think this is going to be an area where we can definitely be highly competitive and successful.

所以我認為這是我們非常興奮的事情。事實上，我們認為 V116 真正實現了這一戰略。所以我們對此感到興奮。我們將加快步伐，因為我確實認為這將是一個我們絕對可以極具競爭力和成功的領域。

That will come from Carter Gould with Barclays.

這將來自與巴克萊銀行的卡特古爾德。

Dean, just real quick, I want to ask you, come back to the subcutaneous formulation of pembro. Is that Phase III in non-small cell still on track to read out early next year? And how should we think about sort of the clinical measures in that study, not just sort of -- I think the primary end points are around some of the biomarker endpoints? And should that study alone sort of be warranting a filing? Or should we be thinking about it differently?

院長，真的很快，我想問你，回到彭布羅的皮下配方。非小型蜂窩的第三階段是否仍有望在明年初公佈？我們應該如何考慮該研究中的臨床措施，而不僅僅是——我認為主要終點是圍繞一些生物標誌物終點？是否應該僅憑這項研究就需要提交申請？還是我們應該換個角度思考？

Yes. So I just want to emphasize that, that trial is on track, and that trial should -- our intention is it should support filings? I should also emphasize that we have more than just one subcutaneous program and different images and different subcutaneous because we think that there may be a different patient population that will be important for different sort of formulations, the group formulations. I should also emphasize that just like we have Q3 weeks and weeks Q3 weeks -- Q3 weeks and Q6 weeks were intravenous. I think it's also important that we open up that possibility in the subcutaneous range as well.

是的。所以我只想強調，審判正在進行中，而且審判應該——我們的意圖是它應該支持申請？我還應該強調，我們有不止一個皮下計劃和不同的圖像和不同的皮下，因為我們認為可能存在不同的患者群體，這對於不同類型的製劑，組製劑很重要。我還應該強調，就像我們有 Q3 周和 Q3 週一樣 - Q3 周和 Q6 周是靜脈注射的。我認為我們也在皮下範圍內開闢這種可能性也很重要。

Thank you very much, Carter. Rob, any closing comments?

非常感謝你，卡特。羅布，有什麼結束評論嗎？

Yes. Well, I'd just like to thank everyone for joining us today, and maybe I'll just conclude by reiterating my appreciation for the tremendous efforts of the Merck team and really, we're continuing to perform exceedingly well in a tough environment to advance our science and ensure our important medicines and vaccines reach the patients around the world that are counting on us.

是的。好吧，我只想感謝大家今天加入我們，也許我會再次重申我對默克團隊的巨大努力的感謝，真的，我們在艱難的環境中繼續表現出色推進我們的科學並確保我們的重要藥物和疫苗能夠惠及世界各地依賴我們的患者。

So I appreciate that, and I can tell you, I remain very confident in our underwriting momentum, and I look forward to continuing to give you updates on our progress as we move forward.

所以我很感激，我可以告訴你，我對我們的承保勢頭仍然非常有信心，我期待在我們前進的過程中繼續向您提供我們的最新進展。

With that, have a great day.

有了這個，有一個美好的一天。