默克藥廠 (MRK) 2019 Q2 法說會逐字稿

Good morning.

早上好。

My name is Darla, and I will be your conference operator today.

我叫 Darla，今天我將擔任你們的會議接線員。

At this time, I would like to welcome everyone to the Merck & Co.

在這個時候，我想歡迎大家來到默克公司。

Q2 sales and earnings conference call.

Q2 銷售和收益電話會議。

(Operator Instructions)

（操作員說明）

I would now like to turn the call over to Teri Loxam, SVP, Investor Relations and Global Communications.

我現在想把電話轉給投資者關係和全球傳播高級副總裁 Teri Loxam。

Please go ahead.

請繼續。

Thank you, Darla, and good morning.

謝謝你，達拉，早上好。

Welcome to Merck's second quarter 2019 conference call.

歡迎來到默克 2019 年第二季度電話會議。

Today, I'm joined by Ken Frazier, our Chairman and Chief Executive Officer; Rob Davis, our Chief Financial Officer; and Dr. Roger Perlmutter, President of Merck Research Labs, who will each have prepared remarks.

今天，我們的董事長兼首席執行官肯·弗雷澤 (Ken Frazier) 加入了我的行列；我們的首席財務官 Rob Davis；和默克研究實驗室總裁 Roger Perlmutter 博士，他們都將準備好發言。

In addition, I'm also joined by Mike Nally, our Chief Marketing Officer; and Frank Clyburn, our Chief Commercial Officer, who will be available for the Q&A portion of the call.

此外，我們的首席營銷官 Mike Nally 也加入了我的行列；和我們的首席商務官 Frank Clyburn，他將出席電話會議的問答部分。

Before I turn the call over to Ken, I'd like to point out a few items.

在我將電話轉給 Ken 之前，我想指出一些事項。

You will see that we have items in our GAAP results such as acquisition-related charges, restructuring costs and certain other items.

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。

You should note that we have excluded these from our non-GAAP results and provide a reconciliation of these in our press release.

您應該注意，我們已將這些排除在我們的非 GAAP 結果之外，並在我們的新聞稿中提供了這些的調節。

We have also provided a table in our press release to help you understand the sales in the quarter for the business units and products.

我們還在新聞稿中提供了一張表格，以幫助您了解本季度業務部門和產品的銷售額。

I would like to remind you that some of the statements that we make during today's call 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.

我想提醒您，我們在今天的電話會議中所做的一些陳述可能被視為前瞻性陳述，符合 1995 年美國私人證券訴訟改革法案安全港條款的含義。

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

此類聲明是根據默克公司管理層目前的信念做出的，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.

如果我們的基本假設被證明不准確或出現不確定性，實際結果可能與前瞻性陳述中的結果大不相同。

Our SEC filings, including Item 1-A in the 2018 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 forward-looking statements made this morning.

我們向美國證券交易委員會提交的文件，包括 2018 年 10-K 中的第 1-A 項，確定了某些風險因素和警示性聲明，這些風險因素和警告性聲明可能導致公司的實際結果與今天上午發表的任何前瞻性聲明中預測的結果存在重大差異。

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

默克不承擔公開更新任何前瞻性聲明的義務。

You can see our SEC filings as well as today's earnings release on merck.com.

您可以在 merck.com 上查看我們向 SEC 提交的文件以及今天的收益發布。

We have also posted a presentation via the Investors section of merck.com which includes some of the highlights from the quarter.

我們還通過 merck.com 的投資者部分發布了一份演示文稿，其中包括本季度的一些亮點。

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

有了這個，我想把電話轉給肯。

Thank you, Teri.

謝謝你，泰瑞。

Good morning, and thank you all for joining the call.

早上好，感謝大家加入電話會議。

Our science-led strategy, together with our clinical and commercial execution drove another quarter of accelerating revenue growth with strength across our global portfolio.

我們以科學為主導的戰略，加上我們的臨床和商業執行，憑藉我們全球產品組合的實力，推動了又一個季度的加速收入增長。

Our results demonstrate the continued momentum of our business through the first half of the year and further show that our focus on the kind of innovation that significantly improves health outcome is paying off.

我們的結果表明我們的業務在今年上半年持續保持增長勢頭，並進一步表明我們對顯著改善健康結果的創新的關注正在取得成效。

As highlighted at our recent Investor Day, we are confident that our innovative portfolio of products and significant pipeline opportunities, supported by unparalleled R&D and commercial execution, will continue to drive strong growth while we invest in cutting-edge science to deliver breakthroughs over the next decade and beyond.

正如我們最近的投資者日強調的那樣，我們相信，在無與倫比的研發和商業執行的支持下，我們的創新產品組合和重要的管道機會將繼續推動強勁增長，同時我們投資於尖端科學以在未來實現突破十年及以後。

Over the past quarter, we continue to advance our pipeline and presented encouraging data across our programs, including 2 additional regulatory approvals and a filing acceptance for KEYTRUDA, 2 new regulatory approvals in infectious diseases as well as new clinical data on the V114 pediatrics trials, MK-8591 and many others.

在過去的一個季度中，我們繼續推進我們的管道並在我們的計劃中提供令人鼓舞的數據，包括 2 個額外的監管批准和 KEYTRUDA 的備案接受，2 個新的傳染病監管批准以及 V114 兒科試驗的新臨床數據， MK-8591 等等。

Our clinical and regulatory progress reflects Merck's unwavering commitment to biomedical research aimed at bringing forward products that can make a meaningful difference in the lives of patients around the world.

我們的臨床和監管進展反映了默克對生物醫學研究的堅定承諾，旨在推出能夠對世界各地患者的生活產生重大影響的產品。

In addition, we continue to strategically invest in business development to strengthen our pipeline through value-enhancing external opportunities.

此外，我們繼續對業務發展進行戰略投資，以通過增值的外部機會加強我們的管道。

This quarter alone, we announced 2 acquisitions that will bolster our oncology pipeline with Peloton Therapeutics and Tilos Therapeutics, respectively.

僅本季度，我們就宣布了兩項收購，將分別通過 Peloton Therapeutics 和 Tilos Therapeutics 加強我們的腫瘤管道。

We also successfully completed our tender offer for Immune Design and closed on the acquisition of Antelliq in Animal Health.

我們還成功完成了對 Immune Design 的要約收購，並完成了對動物保健領域 Antelliq 的收購。

We remain confident that our strategy, growth prospects, outstanding scientific and commercial talent and leadership team, together with our focus on execution will enable us to drive significant value for patients and shareholders this year and for years to come.

我們仍然相信，我們的戰略、增長前景、傑出的科學和商業人才和領導團隊，以及我們對執行的專注，將使我們能夠在今年和未來幾年為患者和股東帶來巨大的價值。

And with that, I'll now turn the call over to Rob to review the details of our quarterly performance.

有了這個，我現在將電話轉給 Rob，以審查我們季度業績的細節。

Rob?

搶？

Thanks, Ken, and good morning, everyone.

謝謝，肯，大家早上好。

As Ken mentioned, our performance in the second quarter is a clear testament to the strong momentum and growth potential of our business.

正如肯所提到的，我們第二季度的業績清楚地證明了我們業務的強勁勢頭和增長潛力。

Our results over the last several quarters continue to reinforce the confidence we have in our ability to drive sustained long-term revenue growth and meaningful operating margin expansion while maintaining a disciplined capital allocation strategy focused both on investing in the business and returning capital to shareholders.

我們在過去幾個季度的業績繼續增強了我們對推動持續的長期收入增長和有意義的營業利潤率增長的能力的信心，同時保持嚴格的資本配置戰略，重點是投資業務和向股東返還資本。

Now turning to our results.

現在轉向我們的結果。

Total company revenues were $11.8 billion, an increase of 12% year-over-year or 15% excluding the negative impact from foreign currency.

公司總收入為 118 億美元，同比增長 12%，不包括外彙的負面影響，增長 15%。

This growth was led by our human health business, which increased 17% this quarter excluding exchange.

這一增長是由我們的人類健康業務帶動的，該業務本季度增長了 17%（不包括交換）。

Animal Health grew 9% excluding exchange.

不包括交換在內的動物保健業務增長了 9%。

The remainder of my comments pertaining to sales will all be on an ex exchange basis.

我關於銷售的其餘評論將全部以交換為基礎。

The increase in human health revenues was led by key products in our oncology, vaccines and hospital businesses.

人類健康收入的增長是由我們的腫瘤學、疫苗和醫院業務的主要產品帶動的。

In oncology, KEYTRUDA sales exceeded $2.6 billion this quarter, an increase of 63% year over year.

在腫瘤領域，KEYTRUDA 本季度銷售額超過 26 億美元，同比增長 63%。

Growth was driven by increased adoption globally in the first-line lung setting as well as uptake in recently approved indications.

增長是由全球一線肺部環境的採用率增加以及最近批准的適應症的吸收所推動的。

In the U.S., strong demand across all indications continues to drive performance.

在美國，所有適應症的強勁需求繼續推動業績。

KEYTRUDA is firmly established as the standard of care for indicated patients in first-line lung and we continue to further penetrate segments of the population, including low and non-PD-L1-expressing patients.

KEYTRUDA 已牢固確立為一線肺部適應症患者的護理標準，我們將繼續進一步滲透人群，包括低表達和非 PD-L1表達的患者。

In addition, we are encouraged by our recent launches in metastatic renal cell carcinoma and adjuvant melanoma where we are already seeing strong adoption by oncologists.

此外，我們對最近在轉移性腎細胞癌和輔助黑色素瘤中的推出感到鼓舞，我們已經看到腫瘤學家的大力採用。

We are also excited about our opportunity in first-line head and neck cancer for which we received approval in June.

我們也對我們在 6 月份獲得批准的一線頭頸癌的機會感到興奮。

With 20 indications currently approved in the United States, we are further establishing KEYTRUDA as a foundational cancer treatment.

目前在美國批准了 20 個適應症，我們正在進一步確立 KEYTRUDA 作為基礎癌症治療。

Outside the U.S., KEYTRUDA sales grew 73% driven by lung as we continue to gain reimbursement for the chemo combo in more countries in the EU.

在美國以外，KEYTRUDA 的銷售額在肺部的推動下增長了 73%，因為我們繼續在歐盟的更多國家獲得化療組合的報銷。

In Japan, we are now the leading anti-PD-1 agent, which speaks to our execution and the breadth of our indications.

在日本，我們現在是領先的抗 PD-1 藥物，這說明了我們的執行力和適應症的廣度。

And in China, we have seen very strong growth given the recent launch in first-line lung and continued uptake in melanoma.

在中國，我們看到了非常強勁的增長，因為最近推出了一線肺癌和黑色素瘤的持續吸收。

And our growth should continue as we reach more patients and expect to launch additional indications.

隨著我們接觸更多患者並期望推出更多適應症，我們的增長應該會繼續。

KEYTRUDA is changing the way in which cancer is being treated, and we are still in the early days of the KEYTRUDA journey.

KEYTRUDA 正在改變治療癌症的方式，我們仍處於 KEYTRUDA 旅程的早期階段。

We remain very confident in the long-term growth potential given our established I-O leadership and our expectation for many additional approvals around the world.

鑑於我們已建立的 I-O 領導地位以及我們對全球許多額外批准的期望，我們對長期增長潛力充滿信心。

Our results also reflect continued strength in both Lynparza and Lenvima products we market in collaboration with AstraZeneca and Eisai, respectively.

我們的結果還反映了我們分別與阿斯利康和衛材合作銷售的 Lynparza 和 Lenvima 產品的持續優勢。

Lynparza revenue more than doubled this quarter, driven by further uptake in ovarian cancer based on the results of SOLO-1 in the United States as well as strength in Europe, China and Japan.

根據 SOLO-1 在美國的結果以及歐洲、中國和日本的實力，本季度 Lynparza 的收入增長了一倍多，這推動了卵巢癌的進一步發展。

Lynparza continues to lead the PARP inhibitor class in the United States with nearly 60% total patient share.

Lynparza 在美國繼續領先 PARP 抑製劑類別，佔總患者份額的近 60%。

We look to further establish Lynparza as the PARP inhibitor of choice in additional chemotypes and in combination with KEYTRUDA.

我們希望進一步確立 Lynparza 作為其他化學類型的首選 PARP 抑製劑，並與 KEYTRUDA 聯合使用。

Lenvima revenue also more than doubled as we continue to drive sales in HCC in the United States and China and launch in several other markets.

隨著我們繼續推動美國和中國 HCC 的銷售並在其他幾個市場推出產品，Lenvima 的收入也增加了一倍多。

We believe Lenvima will be an important product for our oncology portfolio and look forward to the potential for additional indications across our broad development program.

我們相信 Lenvima 將成為我們腫瘤學產品組合的重要產品，並期待在我們廣泛的開發計劃中獲得更多適應症的潛力。

Turning to vaccines.

轉向疫苗。

Our vaccines business reflects strong growth in our pediatric portfolio as well as strength in GARDASIL, which was driven by public sector purchases and greater demand in the adolescent cohorts in the United States as well as continued demand across Europe and the emerging markets especially China.

我們的疫苗業務反映了我們儿科產品組合的強勁增長以及 GARDASIL 的實力，這是由公共部門採購和美國青少年群體更大的需求以及歐洲和新興市場（尤其是中國）的持續需求推動的。

The hospital business benefited from 20% growth in BRIDION, which is annualizing at over $1 billion, reflecting strong performance in the United States as we continue to increase share within the reversal market.

醫院業務受益於 BRIDION 20% 的增長，其年化收入超過 10 億美元，反映了我們在美國的強勁表現，因為我們繼續增加在逆轉市場中的份額。

Animal Health revenue increased 9% this quarter to $1.1 billion.

動物保健收入本季度增長 9% 至 11 億美元。

Livestock grew 13%, primarily due to the contributions from the products acquired in the Antelliq acquisition.

畜牧業增長 13%，主要是由於收購 Antelliq 時獲得的產品的貢獻。

Companion animal sales grew 4% as volume growth in vaccines and insulin products were partially offset by the timing of customer purchases in the prior year from BRAVECTO.

由於疫苗和胰島素產品的銷量增長被前一年客戶從 BRAVECTO 購買的時間部分抵消，伴侶動物銷售額增長了 4%。

Turning to the rest of our P&L, my comments will be on a non-GAAP basis.

談到我們的其他損益表，我的評論將基於非公認會計原則。

Gross margin was 75.4% in the quarter an increase of 100 basis points year-over-year.

本季度毛利率為 75.4%，同比增長 100 個基點。

Recall that a sizable catch-up adjustment for an accrued sales milestone related to Adempas was included in the second quarter of 2018.

回想一下，2018 年第二季度對與 Adempas 相關的應計銷售里程碑進行了相當大的追趕調整。

Operating expenses of $4.8 billion increased 9% year-over-year.

運營費用為 48 億美元，同比增長 9%。

R&D drove a large portion of the increase in spend and reflects higher expenses in support of our discovery and clinical development efforts as well as business development transactions during the quarter.

研發推動了支出增長的很大一部分，反映了本季度支持我們的發現和臨床開發工作以及業務開發交易的支出增加。

SG&A also grew year-over-year reflecting continued investments to accelerate our key growth drivers and the launch of new indications.

SG&A 也同比增長，反映出持續投資以加速我們的主要增長動力和新適應症的推出。

The decrease in other income this quarter reflected the unfavorable year-on-year impact of mark-to-market income on equity securities as well as higher net interest expense.

本季度其他收入的減少反映了按市值計算的收入對股票證券的同比不利影響以及較高的淨利息支出。

Taken together, we earned $1.30 per share, an increase of 25% excluding exchange.

總的來說，我們每股盈利 1.30 美元，不包括匯率增長 25%。

This growth demonstrates the continued momentum in our business as we drive strong top line growth combined with disciplined resource allocation enabling operational leverage.

隨著我們推動強勁的收入增長以及有紀律的資源分配實現運營槓桿，這種增長表明我們業務的持續發展勢頭。

Turning to our outlook for the year.

談談我們今年的展望。

Given the confidence we have in our strong continued performance, we are narrowing and raising both our revenue and non-GAAP EPS guidance ranges for the full year 2019.

鑑於我們對我們強勁的持續表現充滿信心，我們正在縮小和提高 2019 年全年的收入和非 GAAP 每股收益指導範圍。

We now expect revenues of $45.2 billion to $46.2 billion, which represents 7% to 9% growth versus 2018 driven by strength across our key growth pillars.

我們現在預計收入為 452 億美元至 462 億美元，與 2018 年相比增長 7% 至 9%，這主要得益於我們主要增長支柱的強勁增長。

This range assumes a negative impact from foreign exchange of just over 1 percentage point using mid-July rates.

使用 7 月中旬的匯率，該範圍假設外彙的負面影響略高於 1 個百分點。

We expect OpEx to increase by mid-single digits primarily driven by investments in R&D.

我們預計 OpEx 將以中個位數增長，這主要是由研發投資推動的。

We now expect non-GAAP EPS to be in the range of $4.84 to $4.94, which represents growth of approximately 12% to 14% versus 2018.

我們現在預計非 GAAP 每股收益將在 4.84 美元至 4.94 美元之間，與 2018 年相比增長約 12% 至 14%。

We now expect a slightly negative impact from foreign exchange.

我們現在預計外匯會產生輕微的負面影響。

All other elements of our guidance provided in April remain unchanged.

我們在 4 月份提供的指南的所有其他要素保持不變。

In summary, we are operating from a position of strength as reflected in our second quarter results and our updated guidance.

總而言之，正如我們第二季度的業績和更新後的指引所反映的那樣，我們的運營處於有利地位。

We are confident in our ability to drive strong revenue growth in the near and long term, and we remain committed to delivering a leveraged P&L while balancing the need to invest in innovation, all of which we expect will deliver significant and sustainable value to patients and our shareholders.

我們有信心在短期和長期內推動強勁的收入增長，我們仍然致力於在平衡創新投資需求的同時提供槓桿化損益，我們期望所有這些都將為患者和患者帶來顯著且可持續的價值我們的股東。

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

有了這個，我想把電話轉給羅傑。

Thanks, Rob.

謝謝，羅布。

The second quarter was a very important one for Merck Research Laboratories with meaningful progress made in every part of our organization.

第二季度對默克研究實驗室來說非常重要，我們組織的每個部分都取得了有意義的進展。

First, we received numerous approvals from the U.S. Food and Drug Administration including, as previously mentioned, supplementary approval for the use of KEYTRUDA both as monotherapy and in combination with chemotherapy in the first-line treatment of squamous cell carcinoma in the head and neck; and supplemental approval of KEYTRUDA as monotherapy for the third-line treatment of small cell lung cancer.

首先，我們獲得了美國食品和藥物管理局的多項批准，包括如前所述，補充批准使用 KEYTRUDA 作為單一療法和與化療聯合用於頭頸部鱗狀細胞癌的一線治療；補充批准 KEYTRUDA 作為小細胞肺癌三線治療的單一療法。

We also received supplementary approval for ZERBAXA in the treatment of hospital-acquired ventilator-associated pneumonia caused by sensitive bacterial strain.

我們還獲得了 ZERBAXA 治療敏感菌株引起的醫院獲得性呼吸機相關肺炎的補充批准。

This represents an important advancement in the treatment of a life-threatening illness especially when caused by, for example, resistant Pseudomonas species.

這代表了在治療危及生命的疾病方面的重要進步，尤其是當由例如耐藥假單胞菌屬物種引起時。

More recently, we obtained approval of RECARBRIO, our combined imipenem, cilastatin, relebactam therapy for complicated urinary tract or interabdominal infections.

最近，我們獲得了 RECARBRIO 的批准，我們的聯合亞胺培南、西司他丁、relebactam 療法用於復雜的尿路或腹腔間感染。

Relebactam was specifically engineered to enable extended activity of imipenem against certain otherwise resistant bacterial species expressing a form of beta lactamase and is part of our effort to address the increasing threat of antimicrobial resistance.

Relebactam 經過專門設計，可延長亞胺培南對某些表達某種形式的 β 內酰胺酶的耐藥細菌的活性，這是我們應對日益增加的抗菌素耐藥性威脅的努力的一部分。

During the second quarter, we also had the opportunity to review exciting new data from our antiretroviral program including 48-week data from the combination of doravirine with our new nucleosidal reverse transcriptase translocation inhibitor, islatravir, for the maintenance of low viral burdens in patients infected with human immunodeficiency virus.

在第二季度，我們還有機會回顧我們抗逆轉錄病毒計劃的令人興奮的新數據，包括 doravirine 與我們新的核苷逆轉錄酶易位抑製劑 islatravir 聯合使用的 48 週數據，用於維持感染患者的低病毒負荷與人類免疫缺陷病毒。

These data, which were presented last week at the International AIDS Society meetings in Mexico City, were complemented by studies of a subcutaneous islatravir implant that might permit long-term, perhaps once yearly prophylaxis against HIV infection.

上週在墨西哥城舉行的國際艾滋病協會會議上公佈的這些數據得到了對皮下注射 islatravir 植入物的研究的補充，這種植入物可能允許長期預防 HIV 感染，也許每年一次。

In the infectious disease space, we also presented data on the immunogenicity of V114, our new 15-valent pneumococcal conjugate vaccine in pediatric populations.

在傳染病領域，我們還提供了有關 V114 免疫原性的數據，這是我們在兒科人群中使用的新型 15 價肺炎球菌結合疫苗。

We are very enthusiastic about V114 for which Phase III data from our comprehensive development program will become available beginning towards the end of this year.

我們對 V114 非常感興趣，我們綜合開發計劃的 III 期數據將於今年年底開始提供。

Returning to the oncology space.

回到腫瘤學領域。

Just yesterday, we announced that the Data Monitoring Committee supervising our KEYNOTE-522 Phase III study of neoadjuvant and adjuvant KEYTRUDA combined with chemotherapy found that KEYTRUDA treatment was associated with an improvement in pathologic complete response rates, 1 of 2 dual primary endpoints on the study as compared with chemotherapy alone.

就在昨天，我們宣布數據監測委員會監督我們的新輔助和輔助 KEYTRUDA 聯合化療的 KEYNOTE-522 III 期研究發現，KEYTRUDA 治療與病理完全緩解率的改善有關，這是該研究的 2 個雙重主要終點之一與單純化療相比。

I wish to make 2 key points regarding this study: First, neoadjuvant therapy occupies an increasingly important role in the treatment of breast cancer especially in the triple-negative subset which represents between 15% and 20% of breast cancers.

關於這項研究，我想提出兩個關鍵點：首先，新輔助治療在乳腺癌的治療中扮演著越來越重要的角色，尤其是在佔乳腺癌總數 15% 至 20% 的三陰性亞群中。

In this setting, the use of neoadjuvant therapy can reduce tumor burden, permit less-aggressive surgical resection and provide improvement in long-term outcomes.

在這種情況下，新輔助治療的使用可以減輕腫瘤負荷，允許進行較不積極的手術切除並改善長期結果。

Second, achievement of a pathologic complete response in which examination of the surgical specimen shows that tumor cells have been eliminated has been repeatedly associated with improved event-free survival and overall survival in this often quite aggressive malignancy.

其次，實現病理學完全緩解（手術標本檢查顯示腫瘤細胞已被清除）與這種通常極具侵襲性的惡性腫瘤的無事件生存率和總生存率的改善反復相關。

Hence we are very encouraged by the interim analysis demonstrating successful achievement of this endpoint.

因此，中期分析表明成功實現了這一終點，我們對此感到非常鼓舞。

In this context, the KEYNOTE-522 Data Monitoring Committee recommended that the study continue unchanged until the data become mature enough to assess event-free survival.

在這種情況下，KEYNOTE-522 數據監測委員會建議該研究繼續保持不變，直到數據變得足夠成熟以評估無事件生存期。

In the meantime, we look forward to discussing the KEYNOTE-522 data with regulatory authorities and to presenting our data in an upcoming scientific meeting.

與此同時，我們期待與監管機構討論 KEYNOTE-522 數據，並在即將召開的科學會議上展示我們的數據。

Finally, I wish to note that we anticipate that the brisk pace of regulatory approvals in major jurisdictions that we have achieved during the first 6 months of the year will continue especially in the oncology space.

最後，我想指出，我們預計今年前 6 個月我們在主要司法管轄區取得的監管批准的快速步伐將繼續，尤其是在腫瘤學領域。

I look forward to sharing these notifications with you in due course.

我期待在適當的時候與您分享這些通知。

Now my colleagues and I will take your questions.

現在我和我的同事們將回答你們的問題。

Thanks, Roger.

謝謝，羅傑。

Darla, we'll turn it over to the Q&A portion.

Darla，我們將把它轉到問答部分。

(Operator Instructions)

（操作員說明）

(Operator Instructions) And your first question is from Terence Flynn with Goldman Sachs.

（操作員說明）你的第一個問題來自高盛的特倫斯弗林。

Ken, there's obviously been a more significant focus on larger deals in this space following some of the recent announcements.

肯，在最近的一些公告之後，顯然更關注這個領域的大型交易。

Would just welcome your latest thoughts here on Merck's capital allocation strategy.

歡迎您在這裡發表對默克資本配置策略的最新想法。

I know you touched on this a little bit at your Investor Day about a month ago but just wondering if you could provide us an update there.

我知道你大約一個月前在你的投資者日談到了這一點，但只是想知道你是否可以在那裡向我們提供更新。

Thank you very much for the question, Terence.

非常感謝你提出這個問題，特倫斯。

We have watched some of the activity around us in the sector.

我們已經觀察了我們周圍該行業的一些活動。

I think each one of those companies is evaluating their own growth prospects over the next few years.

我認為這些公司中的每一家都在評估自己未來幾年的增長前景。

We feel very, very confident in our growth prospects going forward.

我們對未來的增長前景感到非常非常有信心。

As we have said in the past, given all of that, we're not interested particularly in a large merger that we believe can be disruptive to the company including R&D.

正如我們過去所說，考慮到所有這些，我們對我們認為可能對包括研發在內的公司造成破壞的大型合併並不特別感興趣。

We continue to look at bolt-on deals.

我們繼續關注補強交易。

We do look across the spectrum in terms of size for bolt-ons.

我們確實在螺栓固定的尺寸方面考慮了整個範圍。

We don't divide it by a dollar amount.

我們不會將其除以美元金額。

But at the end of the day, we think the operational complexity, the cultural disruption, the R&D disruption that has been associated with large mergers counsel that we should not go there particularly because we feel very confident about our ability to grow our company organically supplemented by bolt-on deals.

但歸根結底，我們認為與大型合併顧問相關的運營複雜性、文化中斷、研發中斷我們不應該去那裡，特別是因為我們對我們有機地發展公司的能力非常有信心通過補強交易。

It's from Seamus Fernandez with Guggenheim.

它來自古根海姆的 Seamus Fernandez。

Maybe just 2 very quickly.

也許很快就只有 2 個。

On the first one, some spectacular growth in pediatric vaccines across the board as well as GARDASIL.

在第一個方面，兒科疫苗以及 GARDASIL 的全面增長令人矚目。

Could you guys just help us more fully understand the sustainability of the kind of growth that we saw this quarter?

你們能不能幫助我們更全面地了解我們在本季度看到的這種增長的可持續性？

And then just incremental to that, if you could just comment on what happened with NuvaRing this quarter in particular.

如果您可以特別評論本季度 NuvaRing 發生的事情，那麼就只是增量。

And then the second question, just broadly speaking, for Roger, 8591, the data looks solid for the doravirine combination.

然後是第二個問題，從廣義上講，對於 Roger，8591，doravirine 組合的數據看起來很可靠。

Obviously the PrEP information is quite impressive and exciting particularly if you can get to annual dosing with the implants.

顯然，PrEP 信息非常令人印象深刻和令人興奮，特別是如果您可以使用植入物進行年度給藥。

But just wanted to better understand how you guys are working towards finding a better partner than doravirine for 8591.

但只是想更好地了解你們如何努力尋找比 8591 多拉韋林更好的合作夥伴。

And if you're willing to work with other companies and collaborate on those programs.

如果您願意與其他公司合作並在這些項目上進行協作。

That was -- those were some concerns raised by physicians that other great products are out there and that unfortunately it doesn't look like the companies are collaborating with each other on that front.

那是 - 這些是醫生提出的一些擔憂，即其他偉大的產品在那裡，不幸的是，看起來這些公司並沒有在這方面相互合作。

So just wanted to ask on that front.

所以只想問一下這方面的問題。

Great.

偉大的。

Thanks, Seamus.

謝謝，西默斯。

We'll start with Frank.

我們將從弗蘭克開始。

Sure, Seamus.

當然，西莫。

Let me start with NuvaRing.

讓我從 NuvaRing 開始。

No really new news there, no generic entry this quarter, Seamus.

那裡沒有真正的新消息，本季度沒有通用條目，Seamus。

So we continue to promote NuvaRing as we have done in the past.

所以我們像過去一樣繼續推廣 NuvaRing。

With regards to vaccines, a couple of things.

關於疫苗，有幾件事。

Let me start with GARDASIL.

讓我從 GARDASIL 開始。

GARDASIL had a very strong quarter, growth of 50% if you would exclude exchange on a global basis.

GARDASIL 有一個非常強勁的季度，如果你不考慮全球範圍內的交換，增長了 50%。

We did see in the U.S., we did see CDC purchases in Q2 of this year which actually took place in Q1 of last year.

我們確實在美國看到，我們確實看到今年第二季度 CDC 的採購實際上發生在去年第一季度。

So you do see some bumpiness with some of our vaccine sales.

所以你確實看到我們的一些疫苗銷售有些顛簸。

But I would ask to take a look, Seamus, on a year-to-date basis, vaccines for GARDASIL globally is up about 35%.

但我想看一下，Seamus，從年初至今，全球 GARDASIL 疫苗增長了約 35%。

So we're seeing very strong demand, especially in 11- to 12-year old cohorts in the U.S. and some in the 19 to 26 cohorts.

因此，我們看到了非常強勁的需求，尤其是在美國 11 至 12 歲的人群和一些 19 至 26 歲的人群中。

We're also seeing very strong ex U.S. demand, as we talked about in the Investor Day in particular in China, in Europe in a lot of the gender-neutral programs that are rolling out.

我們還看到非常強勁的美國需求，正如我們在投資者日談到的那樣，特別是在中國，在歐洲，許多正在推出的性別中立計劃。

So we're still very confident in our growth prospects for GARDASIL.

因此，我們對 GARDASIL 的增長前景仍然充滿信心。

The pediatric vaccines did also see a very strong quarter this quarter.

兒科疫苗本季度也確實表現強勁。

That was driven by demand as well.

這也是由需求驅動的。

There was some buying to the private sector within the U.S. this quarter based on some of the measles outbreaks that you read in the news.

根據您在新聞中讀到的一些麻疹疫情，本季度美國私營部門進行了一些採購。

And we do believe that we'll continue to see growth for our pediatric vaccines going forward.

我們確實相信，我們將繼續看到兒科疫苗的增長。

So the durability of our vaccine business we feel very good about both for near-term and long-term growth as we mentioned just on Investor Day.

因此，正如我們剛剛在投資者日提到的那樣，我們對疫苗業務的持久性感到非常滿意，無論是短期增長還是長期增長。

Thanks.

謝謝。

Seamus, it's Roger.

西默斯，是羅傑。

With regard to islatravir, MK-8591, I mean, first of all I would say again, the performance of islatravir is quite remarkable.

關於islatravir，MK-8591，我的意思是，首先我要再說一遍，islatravir的表現是非常出色的。

And especially in the implant setting, the durability is remarkable and it's important to note the very long intracellular half life of islatravir and the very impressive resistance profile.

尤其是在植入物設置中，耐用性非常出色，重要的是要注意 islatravir 非常長的細胞內半衰期和非常令人印象深刻的耐藥性。

I would take nothing away from doravirine in terms of its capabilities.

就其功能而言，我不會從 doravirine 中拿走任何東西。

For many in the market, they're used to the previous non-nucleoside reverse transcriptase inhibitors, (inaudible) in particular, which had a lot of adverse events associated with them.

對於市場上的許多人來說，他們已經習慣了以前的非核苷逆轉錄酶抑製劑，特別是（聽不清），它們有很多與之相關的不良事件。

Doravirine is superior to those and is a very effective agent.

Doravirine 優於那些，是一種非常有效的藥物。

And I think the combination of islatravir and doravirine will be good.

而且我認為islatravir和doravirine的組合會很好。

That said, we're also considering lots of other combinations and had lots of other conversations.

也就是說，我們也在考慮許多其他組合，並進行了很多其他對話。

And over time, you'll have the opportunity to see the broader impact of islatravir in a variety of different settings.

隨著時間的推移，您將有機會在各種不同的環境中看到 islatravir 的更廣泛影響。

Important thing to emphasize is that it can be administered on a daily, a weekly or monthly or even a longer duration regimen which offers great possibilities, I think, for changing treatment patterns in HIV-infected individuals.

需要強調的重要一點是，它可以每天、每週或每月甚至更長時間的方案給藥，我認為這為改變 HIV 感染者的治療模式提供了很大的可能性。

It's from Andrew Baum with Citi.

它來自花旗銀行的 Andrew Baum。

A couple questions, please.

請問幾個問題。

Firstly, interested on your thoughts on the Senate proposal to fund catastrophic coverage given your exposure to Lenvima, Lynparza, JANUVIA and others.

首先，考慮到您接觸過 Lenvima、Lynparza、JANUVIA 和其他藥物，您對參議院為災難性保險提供資金的提議感興趣。

Second, on islatravir, a question for Roger.

其次，關於 islatravir，有一個問題要問 Roger。

Thinking about PrEP both with the implant as well as the once monthly, do you think the FDA is ready to accept anything other than traditional noninferiority trials?

考慮到植入物和每月一次的 PrEP，您認為 FDA 是否準備好接受傳統非劣效性試驗以外的任何試驗？

And what do you think that could do to the time lines in order to bringing islatravir to market as PrEP?

您認為將依拉曲韋作為 PrEP 推向市場對時間線有何影響？

Okay.

好的。

So let me just comment generally about what's happening with the various things that are going on and some of these proposals that were included in the Senate finance package.

因此，讓我對正在發生的各種事情以及參議院財政方案中包含的其中一些提案進行一般性評論。

Let me start by saying that as a company, we are very supportive of the kinds of changes that will relieve patients in terms of their out-of-pocket costs.

首先讓我說，作為一家公司，我們非常支持能夠減輕患者自付費用的各種變化。

I think the catastrophic changes are a step in the right direction, but that's a very small number of people who actually progress through the system and get to catastrophic.

我認為災難性的變化是朝著正確方向邁出的一步，但只有極少數人真正在系統中取得進步並走向災難性的變化。

So we continue to work with people as part of a legislative process and the administration because we support lowering costs for seniors at the counter and not just at the catastrophic portion.

因此，作為立法程序和行政部門的一部分，我們將繼續與人們合作，因為我們支持降低老年人在櫃檯的成本，而不僅僅是在災難性部分。

And so with respect to the impact on our own portfolio, I'm going to turn it over to Frank.

因此，關於對我們自己的投資組合的影響，我將把它交給弗蘭克。

Yes, so just on the oncology front, I think you heard from our colleagues at AstraZeneca, Lynparza for Part D is -- approximately 25% of our business flows through Part D. To remind everyone with regards to KEYTRUDA, that is reimbursed through Part B. So it is not a Part D product.

是的，所以就腫瘤學方面而言，我想你從阿斯利康的同事那裡聽說，D 部分的 Lynparza 是——我們大約 25% 的業務流經 D 部分。提醒大家關於 KEYTRUDA 的問題，這是通過部分報銷的B. 所以它不是 D 部分產品。

So we feel as though we're balanced across our oncology portfolio going forward.

因此，我們覺得我們在未來的腫瘤產品組合中是平衡的。

Roger?

羅傑？

Yes, and Andrew, with respect to the PrEP regimen, I think it's a great concern to the community as a whole that if one has to do active comparator controls, because of (inaudible), that's understandable.

是的，Andrew，關於 PrEP 方案，我認為整個社區都非常關心，如果必須進行主動比較器控制，因為（聽不清），這是可以理解的。

The event rates are so low that you will need very, very large populations and very difficult to execute clinical trials.

事件發生率如此之低以至於您將需要非常非常大的人群並且很難執行臨床試驗。

FDA and other regulatory agencies are not unaware of this.

FDA 和其他監管機構並非不知道這一點。

There have been discussions among a variety of sponsors and particularly in the very active patient community about this and what could be done.

各種贊助商之間，特別是在非常活躍的患者社區中，已經就此以及可以做些什麼進行了討論。

And we have a lot of ideas in mind.

我們有很多想法。

But thus far we don't really have a novel trial design that will permit more rapid registration.

但到目前為止，我們還沒有真正能夠實現更快速註冊的新穎試驗設計。

Watch this space.

關注此空間。

I mean we're very concerned about this issue.

我的意思是我們非常關心這個問題。

It's from Chris Schott with JPMorgan.

它來自摩根大通的 Chris Schott。

Just 2 here.

這裡只有 2 個。

Maybe first, elaborate a little bit more on the China dynamics driving that 51% growth.

也許首先，請詳細說明推動 51% 增長的中國動力。

I guess what products in particular are behind this?

我想這背後有哪些產品？

And can you remind us the overall size of your China business at this point.

您能否提醒我們目前您在中國業務的總體規模？

My second question was just KEYTRUDA in RCC.

我的第二個問題只是 RCC 中的 KEYTRUDA。

Can we just get a quick update in terms of uptake you're seeing so far?

我們能否就您目前看到的吸收情況快速更新？

Where in the market you're seeing the most traction with the data, et cetera?

您在市場上的哪些地方看到數據最受關注，等等？

Just -- I know this is obviously an important new indication for you guys.

只是——我知道這對你們來說顯然是一個重要的新跡象。

Chris, it's Frank.

克里斯，是弗蘭克。

On China, China is about $725 million this quarter.

在中國方面，中國本季度約為 7.25 億美元。

And it grew, to your point, 50%.

就你的觀點而言，它增長了 50%。

It's really being driven by a number of products.

它實際上是由許多產品驅動的。

As we mentioned, we pivoted to innovation, so our oncology portfolio, Lynparza, Lenvima, KEYTRUDA is driving growth.

正如我們所提到的，我們專注於創新，因此我們的腫瘤產品組合 Lynparza、Lenvima、KEYTRUDA 正在推動增長。

GARDASIL has had a significant uptake in China.

GARDASIL 在中國的知名度很高。

We have NRDL listing also for JANUVIA.

我們也有 JANUVIA 的 NRDL 清單。

So it's a broad-based, innovative portfolio that is driving that 50% growth, and we believe that will continue in China.

因此，推動 50% 增長的是基礎廣泛的創新產品組合，我們相信這種情況將在中國繼續。

With regards to RCC, we're very excited, Chris, about where we are to date.

關於 RCC，Chris，我們對迄今為止的進展感到非常興奮。

As we mentioned when we rolled out the data for RCC, it's important to note that KEYTRUDA plus axitinib shows a benefit across all 3 risk groups, which differentiates us from the competition.

正如我們在推出 RCC 數據時提到的，重要的是要注意 KEYTRUDA 加 axitinib 在所有 3 個風險組中顯示出益處，這使我們從競爭中脫穎而出。

So we're seeing uptake across all 3 risk groups, and it's really based on the strong overall survival, progression-free survival and very strong response rates.

因此，我們看到了所有 3 個風險組的吸收，這實際上是基於強大的總體生存率、無進展生存率和非常高的反應率。

80% of our targeted accounts in the U.S. have adopted this regimen into their guidelines, which I think is a very strong early indicator.

我們在美國的目標客戶中有 80% 已將此方案納入其指導方針，我認為這是一個非常有力的早期指標。

And we're seeing and hearing very strong feedback from both community and academic physicians.

我們看到並聽到來自社區和學術醫生的非常強烈的反饋。

So I feel really good, Chris, about RCC in the U.S. And as you know, we also plan to be rolling that out around the world.

因此，克里斯，我對美國的 RCC 感覺非常好。正如你所知，我們還計劃將其推廣到世界各地。

So we see this as a key indication, key growth drivers for us going forward.

因此，我們認為這是一個關鍵指標，是我們前進的關鍵增長動力。

Great.

偉大的。

And Roger on 522 -- sorry, my bad.

羅傑在 522 上——抱歉，我的錯。

I misheard the question, apologies.

我聽錯了問題，抱歉。

It's from Navin Jacob with UBS.

它來自瑞銀集團的 Navin Jacob。

Two.

二。

Sorry, if I missed this.

對不起，如果我錯過了這個。

But will it be possible to quantify how much of the U.S. GARDASIL public sector buying pattern was?

但是否有可能量化美國 GARDASIL 公共部門的購買模式有多少？

If you could actually quantify that amount, that will be helpful.

如果你真的能量化這個數量，那將是有幫助的。

And then just on KEYTRUDA plus Lynparza in first-line lung, can you remind us where those trials are?

然後就 KEYTRUDA 加 Lynparza 在一線肺部，你能提醒我們這些試驗在哪裡嗎？

When we could expect to see readouts there?

我們什麼時候可以在那裡看到讀數？

And as a corollary to that, KEYTRUDA in prostate cancer, you were going to be starting a -- 3 Phase III trials there as well.

作為一個推論， KEYTRUDA 在前列腺癌中的應用，你也將在那裡開始一項 3 期 III 期試驗。

Wondering when we could hear updates from those trials as well.

想知道我們什麼時候也能聽到這些試驗的更新。

Let's start with Roger.

讓我們從羅傑開始。

Great.

偉大的。

Okay.

好的。

So as we have discussed, and we've showed some data from our Investor Day, there's quite a large opportunity for combinations of KEYTRUDA with Lynparza.

因此，正如我們所討論的那樣，我們已經展示了投資者日的一些數據，KEYTRUDA 與 Lynparza 的組合有很大的機會。

And in one of those cases, it's prostate cancer.

在其中一種情況下，它是前列腺癌。

We have indicated that we will be starting registration-enabling studies for those.

我們已經表示，我們將開始為這些研究提供註冊支持。

And as the studies move forward, obviously they take some time to conduct, we'll then have a chance to update you on the results.

隨著研究的推進，顯然他們需要一些時間來進行，然後我們將有機會向您更新結果。

But we're enthusiastic about the opportunity of the combination and believe that there will be many circumstances.

但我們對合併的機會充滿熱情，並相信會有很多情況。

I should point out that not only the Lynparza combination but the Lenvima combination as well, where we just received breakthrough designation for the hepatocellular carcinoma first-line indication, too.

我應該指出，不僅是 Lynparza 組合，還有 Lenvima 組合，我們剛剛獲得了肝細胞癌一線適應症的突破性指定。

So there's an awful lot going on in combination studies with both agents.

所以有很多關於這兩種藥物的聯合研究。

Frank?

坦率？

Yes.

是的。

And on GARDASIL, as I mentioned, we have a CDC purchase in Q2, which was not purchased in Q2 of 2018.

在 GARDASIL 上，正如我提到的，我們在第二季度購買了 CDC，這不是在 2018 年第二季度購買的。

It was actually purchased in Q1 of '18.

它實際上是在 18 年第一季度購買的。

So the way in which I would characterize GARDASIL is in the U.S., year-to-date we have grown 20% when you look on a 6-month basis.

因此，我描述 GARDASIL 的方式是在美國，從 6 個月的基礎上看，今年迄今我們已經增長了 20%。

I think that's the best way to look at it from a GARDASIL perspective.

我認為這是從 GARDASIL 的角度來看它的最佳方式。

So think of the U.S. growing about 20% right now versus prior year for the half year mark.

因此，想一想美國在半年內與上一年相比增長了約 20%。

Because you are going to see different timing with regards to CDC purchases.

因為您將看到 CDC 購買的不同時間。

It's from Umer Raffat with Evercore.

它來自 Evercore 的 Umer Rafat。

I have 2, if I may.

如果可以的話，我有 2 個。

You mentioned low complexity as being a key consideration for bolt-on you're looking at.

您提到低複雜性是您正在尋找的附加功能的關鍵考慮因素。

And in that vein, I guess my question is are you open to therapeutic areas like orphan?

在這種情況下，我想我的問題是你對像孤兒這樣的治療領域持開放態度嗎？

And also if there's a company with, let's say $50 billion market cap or value, is that still a tuck-in as long as the complexity is low?

而且，如果有一家公司的市值或價值為 500 億美元，那麼只要復雜性很低，這仍然是一個機會嗎？

And secondly, on gross margin, so I see 2 big drivers going forward, 1 of course being KEYTRUDA's Bristol-Myers royalty reduction in 2023.

其次，在毛利率方面，我認為未來有兩個主要驅動因素，其中一個當然是 KEYTRUDA 在 2023 年減少百時美施貴寶的特許權使用費。

But also, anything you may be baking in on pricing reform?

而且，您可能會參與定價改革嗎？

I was curious if you could add numbers around each of those.

我很好奇你是否可以在每一個周圍添加數字。

Well, I'll start with the BD question.

好吧，我將從 BD 問題開始。

Thanks, Umer, for your question.

謝謝你，Umer，你的問題。

I don't think the size is the issue necessarily for complexity.

我認為大小不一定是複雜性的問題。

I think it has to do with whether or not the 2 companies overlap and whether or not we're spending a lot of our time integrating IT systems, manufacturing systems.

我認為這與兩家公司是否重疊以及我們是否花費大量時間整合 IT 系統、製造系統有關。

So if it's a true add-on, a separate kind of business, a true bolt-on, I don't think the size drives the complexity at all.

因此，如果它是一個真正的附加組件，一種獨立的業務，一個真正的附加組件，我認為規模根本不會導致複雜性。

As it relates to orphan versus other kinds, our preference is to do the most good for the most people.

由於它涉及孤兒與其他類型，我們的偏好是為大多數人做最好的事情。

But having said that, we are not against the right kind of therapy, even including orphan indications or orphan approaches to therapy.

但話雖如此，我們並不反對正確的治療方法，甚至包括孤兒適應症或孤兒治療方法。

What we care about is are we getting good science that we can leverage together with our internal efforts to actually create value for shareholders as well as patients.

我們關心的是我們是否獲得了好的科學，我們可以利用這些科學與我們的內部努力一起為股東和患者創造價值。

This is Rob.

這是羅布。

To your question, just to remind everyone, for gross margin, over time as we indicated at the Investor Day, we do expect to see gross margin generally flat.

對於你的問題，只是提醒大家，對於毛利率，正如我們在投資者日指出的那樣，隨著時間的推移，我們確實預計毛利率總體持平。

Because while we do see product mix benefits flowing from products like KEYTRUDA and our vaccines business, we also, as we mentioned, have assumed negative price going forward.

因為雖然我們確實看到 KEYTRUDA 和我們的疫苗業務等產品帶來產品組合效益，但正如我們提到的，我們也假設未來價格為負。

The impact of royalties, you've hit obviously the one with KEYTRUDA that does step down in 2023 and the impact of the collaborations which in the near term will be a drag on margin, although long term would become accretive, we haven't given specific dollar numbers to those.

特許權使用費的影響，你顯然已經觸及了 KEYTRUDA 的影響，它確實在 2023 年下台，合作的影響在短期內將拖累利潤率，儘管長期會增加，但我們還沒有給出具體的美元數字。

And frankly, we don't want to get that specific in guidance.

坦率地說，我們不想獲得具體的指導。

But clearly how those interplay will determine whether you see our product gross margins slightly up, slightly down or flat over the period with most of what's driving our operating margin expansion, as we've talked about, coming from reducing growth in operating expense relative to sales.

但很明顯，這些相互作用將如何決定你是否看到我們的產品毛利率在此期間略有上升、略有下降或持平，正如我們所討論的，推動我們營業利潤率增長的大部分因素來自於營業費用增長相對於銷售量。

It's from David Risinger with Morgan Stanley.

它來自摩根士丹利的 David Risinger。

I guess first I'd like to start with actually the last comment.

我想首先我想從最後一條評論開始。

And I know that this was mentioned previously at the analyst meeting.

我知道之前在分析師會議上提到過這一點。

But in terms of Merck's projection of negative price going forward, that's a bit different than some of your peers.

但就默克公司對未來負價格的預測而言，這與您的一些同行略有不同。

I think some of your peers talk about flat pricing.

我認為您的一些同行談論統一定價。

So maybe you could provide some more color regarding what you see as the biggest downward pressures on price for Merck going forward.

因此，也許您可以提供更多顏色，說明您認為默克未來面臨的最大價格下行壓力是什麼。

And then second, could you just provide an update on the growing meningitis concerns?

其次，您能否提供有關日益嚴重的腦膜炎問題的最新消息？

I jumped on the call late, so I don't know if this was addressed, but wanted to hear about that topic and then also the durability of Merck's PROQUAD, M-M-R II revenue line strength.

我接電話很晚，所以我不知道這個問題是否得到解決，但想听聽這個話題，然後是默克公司 PROQUAD、M-M-R II 收入線實力的持久性。

Great.

偉大的。

Let's start with Rob.

讓我們從羅布開始吧。

So thanks for the question.

所以謝謝你的問題。

With regards to pricing, again, I think the important thing to focus on is how we see the mix going forward.

關於定價，我認為需要重點關注的是我們如何看待未來的組合。

And I can't speak to what our competitors are implying.

我不能說我們的競爭對手在暗示什麼。

But if you recall, we've actually seen negative price quite some time outside the United States, so that's not a new phenomenon.

但如果你還記得的話，我們實際上已經在美國以外的很長一段時間內看到了負價格，所以這並不是一個新現象。

We've been absorbing headwinds in price outside the United States for several years.

多年來，我們一直在吸收美國以外的價格逆風。

Historically, that was offset by price increases in the United States.

從歷史上看，這被美國的價格上漲所抵消。

As we look going forward, we no longer see the benefit of those price increases in the United States because of obviously the changing dynamics.

展望未來，由於動態的變化，我們不再看到美國價格上漲的好處。

And so as you look in total, we do continue to believe we're going to see declining price, as we look forward, impacting our margins.

因此，從總體上看，我們確實繼續相信我們會看到價格下降，正如我們期待的那樣，這會影響我們的利潤率。

Thanks.

謝謝。

And Frank on the pediatric vaccines?

弗蘭克在兒科疫苗方面？

Yes.

是的。

On the pediatric vaccines, we are continuing to see very good demand within the pediatric vaccines.

在兒科疫苗方面，我們繼續看到兒科疫苗的需求非常旺盛。

And clearly, the measle outbreak has driven some of that demand, especially in the private sector.

顯然，麻疹疫情推動了部分需求，尤其是在私營部門。

We also did see buy-in this quarter in Q2.

我們也確實在第二季度看到了本季度的買入。

We do anticipate that some of that buy-in will come out in Q3 and Q4.

我們確實預計其中一些買入將在第三季度和第四季度出現。

But as I mentioned before, we see our pediatric vaccine business as a very strong part of our growth story.

但正如我之前提到的，我們將兒科疫苗業務視為我們增長故事中非常重要的一部分。

And we see it as a very durable business going forward.

我們認為這是一項非常持久的業務。

It's from Tim Anderson with Wolfe Research.

它來自 Wolfe Research 的 Tim Anderson。

A couple of questions.

幾個問題。

A longer-term question on KEYTRUDA.

關於 KEYTRUDA 的長期問題。

We published an analysis a while back claiming that cancer drugs, very often, ultimately sell much more outside the U.S. and in the U.S. as they mature to the tune of 50% more or so.

我們不久前發表了一份分析報告，稱抗癌藥物通常最終會在美國以外和美國境內銷售更多，因為它們的成熟度要高出 50% 左右。

When I look at how we and the analyst community at large models KEYTRUDA, and other PD-1s for that matter, knowing everybody really thinks that ex U.S. even surpassing the U.S. And I'm wondering if you can tell us what your long-term model assumes in this regard.

當我看看我們和分析師社區如何研究大型模型 KEYTRUDA 和其他 PD-1 時，知道每個人都真的認為前美國甚至超過美國而且我想知道你是否可以告訴我們你的長期模型在這方面假設。

Could the ex U.S. markets eventually kind of blow away the U.S. market over time?

隨著時間的推移，除美國市場之外的市場最終會不會吹走美國市場？

It could be blowing the dollars more potentially.

它可能更有可能吹美元。

Second question, recent -- Bristol recently top line part 1 of 227 as positive, which I think was a surprise, can you remind us where you are with your CTLA-4 combination program?

第二個問題，最近——布里斯托爾最近將 227 的第 1 部分列為陽性，我認為這是一個驚喜，你能提醒我們你的 CTLA-4 組合計劃在哪裡嗎？

Specifically, what are the latest stage trials and in what tumor types?

具體來說，最新階段的試驗是什麼以及在哪些腫瘤類型中進行？

My guess is you may have kind of backed off this initiative that you started maybe a couple of years ago.

我猜你可能已經放棄了你可能在幾年前開始的這項倡議。

Let's start with Frank on KEYTRUDA.

讓我們從 KEYTRUDA 上的 Frank 開始。

Yes, for KEYTRUDA, we look long term.

是的，對於 KEYTRUDA，我們著眼於長期。

We do see significant opportunity outside the U.S. in particular markets, like China especially when you look at some of the G.I. malignancies and the actual prevalence there.

我們確實在美國以外的特定市場看到了巨大的機會，比如中國，尤其是當你看一些 G.I.惡性腫瘤和那裡的實際患病率。

We are seeing obviously very strong uptake in Japan as well.

我們在日本顯然也看到了非常強勁的吸收。

Not going to give a specific number, but we clearly do see the ex U.S. opportunity as very significant.

不打算給出具體數字，但我們顯然確實認為前美國的機會非常重要。

And in fact this quarter alone, we sold $1.1 billion outside the U.S. It grew 73%.

事實上，僅本季度，我們在美國境外的銷售額就達到了 11 億美元，增長了 73%。

So we see both ex U.S. and U.S. KEYTRUDA opportunities.

因此，我們看到了前美國和美國的 KEYTRUDA 機會。

But clearly, China is the one I would highlight as significant potential growth for us going forward.

但很明顯，中國是我要強調的一個對我們未來具有重大潛在增長的國家。

And Roger.

還有羅傑。

Tim, with respect to CTLA-4-directed therapy, our interest has been in demonstrating or assessing whether or not adding CTLA-4-directed therapy actually has an impact over KEYTRUDA alone.

Tim，關於 CTLA-4 導向療法，我們的興趣一直是證明或評估添加 CTLA-4 導向療法是否真的比單獨使用 KEYTRUDA 有影響。

That is powering the study to see whether CTLA-4 plus KEYTRUDA is in fact superior to KEYTRUDA in any setting.

這為研究提供了動力，以了解 CTLA-4 加 KEYTRUDA 是否實際上在任何情況下都優於 KEYTRUDA。

And we have done that, both with ipilimumab and also with MK-1308, our own CTLA-4-directed therapy.

我們已經做到了這一點，既有易普利姆瑪，也有我們自己的 CTLA-4 導向療法 MK-1308。

And so registration-enabling studies are going on in both setting and with both kinds of combinations which includes, for example, the KEYNOTE-598 study and a couple of others.

因此，支持註冊的研究在兩種環境和兩種組合中都在進行，例如，KEYNOTE-598 研究和其他一些研究。

And we can go through the details with you quite easily on clinicaltrials.gov.

我們可以在 clinicaltrials.gov 上很容易地與您一起了解詳細信息。

It's from Jason Gerberry with Bank of America.

它來自美國銀行的 Jason Gerberry。

First is a follow-up on the Bristol Opdivo, Yervoy data.

首先是對 Bristol Opdivo、Yervoy 數據的跟進。

Just curious, Roger, how do you think oncologists are going to benchmark the CheckMate-227 data against the already approved either Merck combination or KEYTRUDA monotherapy in the PD-L1 greater than 1% populations?

只是好奇，羅傑，你認為腫瘤學家將如何將 CheckMate-227 數據與已經批准的默克組合或 KEYTRUDA 單一療法在 PD-L1 大於 1% 的人群中進行基準測試？

And then my second question, maybe just for Frank.

然後是我的第二個問題，也許只是為了弗蘭克。

Can you frame the importance of NRDL listing for KEYTRUDA in the lung setting?

您能否說明 KEYTRUDA 在肺部環境中列入 NRDL 的重要性？

And what I'm specifically curious about is the percent of the market accessible with and without the listing.

我特別好奇的是上市和未上市的市場份額。

Let's start with Roger.

讓我們從羅傑開始。

Well, Jason, it's really hard to comment on the data from the CheckMate-227 program because we haven't actually seen it.

好吧，Jason，真的很難評論 CheckMate-227 程序的數據，因為我們實際上還沒有看到它。

We have the top line announcement that one part of it with -- in the PD-L1 greater than 1% did succeed in the combination with ipilimumab.

我們有最重要的公告，其中一部分——在 PD-L1 中，超過 1% 的人在與 ipilimumab 的組合中取得了成功。

But we don't know what that success will look like in overall survival.

但我們不知道這種成功在整體生存中會是什麼樣子。

We don't know the hazard rates those would look like.

我們不知道那些看起來像的危險率。

And there's a -- it's a complicated study, as you appreciate, because the study was broken down into multiple parts.

還有一個——這是一項複雜的研究，正如你所理解的，因為這項研究被分解成多個部分。

And a part of it was predicated on a tumor mutational burden analysis and then subsequent PD-L1-directed subset.

其中一部分基於腫瘤突變負荷分析，然後是隨後的 PD-L1 定向子集。

So without actually seeing the data, pretty hard to know how oncologists will respond.

因此，在沒有實際看到數據的情況下，很難知道腫瘤學家會如何應對。

With time, the data become available, and I think people will want to have a look at it and understand what the meaning of that might be.

隨著時間的推移，數據變得可用，我認為人們會想看看它並理解它可能意味著什麼。

I -- our own data, I think are extremely strong, of course, with KEYTRUDA and the combination of KEYTRUDA plus traditional chemotherapy with typically on the order of doubling of overall survival.

我——我們自己的數據，我認為非常強大，當然，KEYTRUDA 和 KEYTRUDA 與傳統化療的組合通常使總生存期翻倍。

So there is important value that can be gained there.

因此，可以在那裡獲得重要的價值。

And we're optimistic that we're going to continue to be able to advance therapies that will improve overall survival in this disease.

我們樂觀地認為，我們將能夠繼續推進能夠提高這種疾病的總體生存率的療法。

Thanks, Roger.

謝謝，羅傑。

We'll go to Frank on the NRDL.

我們會去參加 NRDL 的 Frank。

Yes.

是的。

And just one addition point to what Roger was saying.

只是羅傑所說的一點補充。

Commercially, with regards to lung, I do believe we're in a very strong position with our data.

在商業上，關於肺，我相信我們的數據處於非常有利的地位。

And as you mentioned with monotherapy, on the PD-L1 high population with very strong overall survival as well as KEYNOTE-189 reducing the risk of death in half, that data is playing very well around the world, and it has helped us to penetrate now 8 out of every 10 new eligible patients in lung.

正如你提到的單藥療法，在 PD-L1 高人群中具有非常強的總體生存率以及 KEYNOTE-189 將死亡風險降低一半，該數據在世界範圍內發揮很好，它幫助我們滲透現在每 10 名符合條件的新肺部患者中就有 8 名。

So we feel as though -- there'll be a lot of data readouts here from competition, but we feel as though our data positions us well in lung today and in the future.

所以我們覺得——這裡會有很多來自競爭的數據讀數，但我們覺得我們的數據在今天和未來都能很好地定位我們的肺部。

NRDL.

醫保。

We are waiting to see if we'll be invited to actually participate for next year.

我們正在等著看我們是否會被邀請參加明年的活動。

It is an important potential listing.

這是一個重要的潛在上市。

It does expand the population in China fairly significantly.

它確實相當顯著地擴大了中國的人口。

There is 500,000 to 600,000 lung cancer patients in China.

中國有50萬至60萬肺癌患者。

There's probably 300,000 of those that are part of our labeled indication.

可能有 300,000 個是我們標記的適應症的一部分。

And NRDL gives us a chance, if invited, to expand into that patient population.

如果受到邀請，NRDL 將讓我們有機會擴展到該患者群體。

We'd also like to highlight, we expect to expand our label in China.

我們還想強調，我們希望擴大我們在中國的品牌。

China is going to be important for us, not only for 2020, but 2020 and beyond.

中國對我們來說很重要，不僅在 2020 年，而且在 2020 年及以後。

And we are also seeing good self-pay market uptake in China as well.

我們也看到中國的自費市場接受度很高。

But clearly, we'll keep you informed as the NRDL process unfolds.

但顯然，隨著 NRDL 流程的展開，我們會及時通知您。

It's from Steve Scala from Cowen.

它來自 Cowen 的 Steve Scala。

A couple of questions both for Roger.

羅傑的幾個問題。

If you could clarify your KEYNOTE-522 comments.

如果您可以澄清您的 KEYNOTE-522 評論。

I think you said you needed EFS to file but that you would share the pCR data with regulators.

我想你說你需要 EFS 來歸檔，但你會與監管機構共享 pCR 數據。

So were you implying you would seek to file and potentially garner approval on pCR that is why you're going to share it in the first place?

所以你是在暗示你會尋求提交 pCR 並可能獲得批准，這就是你首先要分享它的原因嗎？

Or are you saying you absolutely definitely need the EFS?

或者您是說您絕對需要 EFS？

And then secondly, if Bristol's 227 delivered a percent of patients alive greater than the 69% that KEYNOTE-189 reported at 12 months, just wondering how Merck would respond.

其次，如果 Bristol 的 227 交付的患者存活率高於 KEYNOTE-189 在 12 個月時報告的 69%，只是想知道默克公司會如何回應。

Or do you think that, that is extremely unlikely?

或者你認為那是極不可能的？

Thanks, Steve.

謝謝，史蒂夫。

So with respect to KEYNOTE-522, the goal in discussing the data with regulatory agencies is to ask whether or not they think that represents a finding of sufficient importance to consider making the drug available for patients in that setting.

因此，關於 KEYNOTE-522，與監管機構討論數據的目的是詢問他們是否認為這代表了一個足夠重要的發現，可以考慮為該環境下的患者提供藥物。

So that's the reason to do it.

所以這就是這樣做的原因。

As I indicated, pathologic complete response is associated with favorable outcome particularly in the breast cancer setting and as have been repeatedly demonstrated, to have that impact in the triple-negative breast cancer setting.

正如我所指出的，病理完全反應與有利的結果相關，特別是在乳腺癌環境中，並且正如已經反复證明的那樣，對三陰性乳腺癌環境具有這種影響。

On the other hand, this is something that agencies have to look at in regard to the totality of the data.

另一方面，這是機構必須考慮的關於數據整體性的事情。

So that's basically where we are there.

所以這基本上就是我們在那裡的地方。

And with regard to 227, pretty hard to respond to hypothetical without actually seeing what the data look like.

關於 227，如果不實際查看數據，很難對假設做出回應。

I really -- I don't know what to say about that.

我真的——我不知道該說些什麼。

I think there's some interest in seeing what the subset data look like.

我認為有些人有興趣查看子集數據的樣子。

Obviously, the flip side of that was that, maybe unsurprisingly, but in light of what we've seen, beginning with CheckMate-026, I mean, the combination of nivolumab plus chemotherapy was not successful in Part 2, which for us, KEYTRUDA plus chemotherapy obviously gives impressive results in terms of overall response rate, progression-free survival, overall survival as we demonstrated repeatedly in non-squamous and squamous small cell non-small cell lung cancer.

顯然，它的另一面是，也許不足為奇，但根據我們所看到的，從 CheckMate-026 開始，我的意思是，nivolumab 加化療的組合在第 2 部分中並不成功，這對我們來說，KEYTRUDA正如我們在非鱗狀和鱗狀小細胞非小細胞肺癌中反复證明的那樣，加上化療顯然在總體反應率、無進展生存期、總體生存率方面取得了令人印象深刻的結果。

So these are behaving differently in these settings for whatever reason.

因此，無論出於何種原因，它們在這些設置中的行為都不同。

Your next question is from Louise Chan with Cantor.

你的下一個問題來自 Louise Chan 和 Cantor。

My first question is on KEYTRUDA in China.

我的第一個問題是關於 KEYTRUDA 在中國的情況。

Just curious, if you will disclose sales there?

只是好奇，你是否會透露那裡的銷售額？

We get that question a lot.

我們經常收到這個問題。

Just seeing if you can provide any color.

只是看看你是否可以提供任何顏色。

And then how will you compete with the local players that are much less expensive on a price basis, at least for now?

然後你將如何與價格便宜得多的本地玩家競爭，至少目前是這樣？

And then second question is just on potential competition for KEYTRUDA from some of the upcoming trial readouts in second half '19 and beyond that will be in non-small cell lung cancer, RCC and melanoma.

然後第二個問題只是關於 KEYTRUDA 的潛在競爭，來自 19 年下半年及以後的一些即將進行的試驗讀數將是非小細胞肺癌、 RCC 和黑色素瘤。

Frank?

坦率？

Yes.

是的。

So we don't intend to actually share our sales numbers for KEYTRUDA in China.

因此，我們不打算實際分享 KEYTRUDA 在中國的銷售數字。

As far as competing with the local players, we feel as though oncology is a data-driven market.

就與本地參與者的競爭而言，我們覺得腫瘤學是一個數據驅動的市場。

There clearly are local players that are entering the market at a lower price.

顯然有本地玩家以較低的價格進入市場。

They are penetrating into some segments of the market.

他們正在滲透到市場的某些部分。

However, we're continuing to see very good penetration and very good growth in China.

然而，我們在中國繼續看到非常好的滲透率和非常好的增長。

There are clearly patients that are in the self-pay markets where we compete today that can afford KEYTRUDA.

在我們今天競爭的自費市場中，顯然有患者能夠負擔得起 KEYTRUDA。

We have our patient assistance programs, and we have a very strong commercial presence in China.

我們有我們的患者援助計劃，我們在中國有非常強大的商業影響力。

So I feel really good that we'll be able to compete with the local players going forward.

所以我感覺非常好，我們將能夠在未來與當地球員競爭。

Great.

偉大的。

And then the KEYTRUDA positioning in the U.S. given peer trials?

然後是 KEYTRUDA 在美國的定位？

Yes.

是的。

I think as we mentioned, there's going to be a lot of competitive data readouts in lung and across many different cancer types.

我認為正如我們提到的那樣，在肺癌和許多不同的癌症類型中將會有很多有競爭力的數據讀數。

What I would say is right now, we are in a very strong first-mover advantage in many of those cancer types.

我現在要說的是，我們在許多癌症類型中處於非常強大的先發優勢。

When you think about 20 indications across 12 different tumors, we right now have built a wall of data that we feel very comfortable with.

當您考慮 12 種不同腫瘤的 20 種適應症時，我們現在已經建立了一個我們感到非常滿意的數據牆。

And in fact, many of the community oncologists are getting significant real-world experience using KEYTRUDA.

事實上，許多社區腫瘤學家正在使用 KEYTRUDA 獲得重要的現實世界經驗。

So we'll have to see how the data unfolds with the competition.

所以我們必須看看數據如何隨著競爭而展開。

But as Roger and I have just mentioned, we feel as though our data right now, strong overall survival across many different cancer types, bladder; renal cell carcinoma; I haven't even spoken about adjuvant melanoma, which is a very important launch for us right now; head and neck, the teams are just launching that indication off a strong overall survival in the first-line setting.

但正如 Roger 和我剛才提到的，我們感覺我們的數據似乎在許多不同類型的癌症、膀胱中都有很強的總體存活率；腎細胞癌；我什至還沒有談到輔助黑色素瘤，這對我們來說是一個非常重要的發射；頭部和頸部，這些團隊剛剛發布了一線環境中強大的整體生存率的跡象。

So we know it is going to be competitive.

所以我們知道它將具有競爭力。

We feel as though we're very well-positioned based on our strategy and the data that we have as well as what you heard in our Investor Day, the significant amount of data to come, not only in the metastatic setting but also in the neoadjuvant and adjuvant setting going forward.

根據我們的戰略和我們擁有的數據以及您在投資者日聽到的內容，我們覺得我們處於非常有利的位置，即將到來的大量數據，不僅在轉移性環境中，而且在新輔助和輔助設置向前發展。

It's from Mara Goldstein with Mizuho.

它來自 Mara Goldstein 和 Mizuho。

(technical difficulty)

（技術難度）

Mara, we can't hear your -- we couldn't hear your question.

瑪拉，我們聽不到你的——我們聽不到你的問題。

If you wouldn't mind repeating that?

如果你不介意重複一遍？

Sure.

當然。

I have 2 questions, and the first is on the KEYTRUDA plus Lynparza trial in non-small cell lung cancer.

我有兩個問題，第一個是關於 KEYTRUDA 加 Lynparza 在非小細胞肺癌中的試驗。

And I'm just wondering what the expectation is in terms of expanding patient population based on that clinical trial.

我只是想知道根據該臨床試驗擴大患者人數的期望是什麼。

And then the second question is one around regulatory strategy in Europe.

然後第二個問題是關於歐洲的監管策略。

Just understanding that yesterday or the day before, we learn that the CHMP had removed accelerated status for Novartis' Zolgensma, but we've also seen this is not an isolated incident with other drugs, and in particular oncology drugs being taken off that accelerator track.

據了解，昨天或前一天，我們了解到 CHMP 已經取消了諾華公司 Zolgensma 的加速狀態，但我們也看到這不是其他藥物的孤立事件，特別是腫瘤藥物被取消加速軌道.

And I'm wondering if the company can share any thoughts around this dynamic and any potential impact on your own regulatory plans in Europe.

我想知道該公司是否可以分享有關這種動態的任何想法以及對您自己在歐洲的監管計劃的任何潛在影響。

Right.

正確的。

Mara, the underlying logic behind KEYTRUDA plus Lynparza in a whole variety of settings is that where there are defects in DNA repair and there are -- those include a whole variety of different defects not just the BRCA1, BRCA 2 indications but a whole variety of different molecular defects.

Mara，在各種情況下，KEYTRUDA 和 Lynparza 背後的潛在邏輯是，在 DNA 修復中存在缺陷的地方——那些包括各種不同的缺陷，不僅是 BRCA1、BRCA 2 適應症，還包括各種各樣的缺陷。不同的分子缺陷。

The effect of Lynparza can be to increase the representation of epitopes that potentially could be recognizable by immune cells, and release of constraints with KEYTRUDA in combination with that should be beneficial.

Lynparza 的作用可能是增加可能被免疫細胞識別的表位的表現，並且與 KEYTRUDA 結合釋放限制應該是有益的。

That's the hypothesis that's being tested in a whole variety of different settings and quite broadly.

這是在各種不同的環境中進行廣泛測試的假設。

So we're enthusiastic about it.

所以我們對此充滿熱情。

We're encouraged that this could be extremely important.

我們感到鼓舞，這可能非常重要。

One of the things I would point out with respect to Lynparza is it's extraordinarily well-tolerated.

關於 Lynparza，我要指出的一件事是它的耐受性非常好。

People stay on it for years, and the ability to maintain the treatment effect as has been shown, for example in the ovarian setting is really quite remarkable.

人們堅持使用它多年，並且已經顯示出維持治療效果的能力，例如在卵巢環境中確實非常了不起。

So that's extremely promising.

所以這是非常有希望的。

With regard to EU strategy, the regulatory strategy really hasn't changed there.

關於歐盟戰略，那裡的監管戰略確實沒有改變。

The EU has a PRIME program for -- within CHMP in order to permit more rapid review in general.

歐盟在 CHMP 內有一個 PRIME 計劃，以便在總體上允許更快速的審查。

The good thing about EU reviews is that they go along a very well-define time line, which we understand extremely well.

歐盟審查的好處是它們遵循了一個非常明確的時間表，我們非常理解這一點。

And at this point, we're moving forward with those EU reviews as we've announced even just this week.

在這一點上，我們正在推進那些歐盟審查，正如我們本周宣布的那樣。

So all of that is going very well for us.

所以所有這一切對我們來說都非常順利。

Thanks, Roger.

謝謝，羅傑。

And we were able to get to all of the callers' questions.

我們能夠回答所有來電者的問題。

So I'll turn it over to Ken for some closing comments.

所以我會把它交給 Ken，請他發表一些結束評論。

Okay.

好的。

I want to thank you again for joining us today.

我想再次感謝你今天加入我們。

As you can see, our strong second quarter results reinforce why we're so confident in our ability to deliver sustained strong growth not only this year but beyond.

正如您所看到的，我們強勁的第二季度業績強化了為什麼我們對我們不僅在今年而且在以後實現持續強勁增長的能力如此有信心。

And as we mentioned in Investor Day, we have a derisked portfolio of innovative assets.

正如我們在投資者日提到的那樣，我們擁有去風險化的創新資產組合。

Together with our differentiated scientific, commercial capabilities and our ability to execute, we believe that uniquely positions Merck to deliver strong results for patients and shareholders well into the future.

加上我們差異化的科學、商業能力和我們的執行能力，我們相信，默克公司在未來為患者和股東帶來強勁業績具有獨特的優勢。

So thanks, again.

再次感謝。

We look forward to joining you in the future.

我們期待著您的加入。

This concludes the Merck & Co.

這是默克公司的結論。

Q2 sales and earnings call.

Q2 銷售和收益電話會議。

You may now disconnect.

您現在可以斷開連接。