默克藥廠 (MRK) 2021 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good morning. My name is Grace Lakra, and I will be your conference operator today. At this time, I would like to welcome everyone to the Merck & Co. Q4 Sales and Earnings Conference Call. (Operator Instructions) Thank you.

    早上好。我的名字是 Grace Lakra,今天我將成為您的會議接線員。在這個時候,我想歡迎大家參加默克公司第四季度銷售和收益電話會議。 (操作員說明)謝謝。

  • I would now like to turn the call over to Peter Dannenbaum, Vice President of Investor Relations. Please go ahead, sir.

    我現在想將電話轉給投資者關係副總裁 Peter Dannenbaum。請繼續,先生。

  • Peter Dannenbaum - VP of IR

    Peter Dannenbaum - VP of IR

  • Thank you, Grace, and good morning. Welcome to Merck's fourth quarter 2021 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.

    謝謝你,格蕾絲,早上好。歡迎來到默克公司 2021 年第四季度電話會議。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 will see that we have items in our GAAP results, such as acquisition-related charges, restructuring costs and certain other items. You should note that we've excluded these from our non-GAAP results and provide a reconciliation in our press release.

    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。

  • I would like to remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    我想提醒您,我們今天所做的一些陳述可能被視為 1995 年美國私人證券訴訟改革法案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。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。

  • Our SEC filings, including Item 1A in the 2020 10-K, identified certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements.

    我們向美國證券交易委員會提交的文件,包括 2020 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 speakers' prepared remarks. The presentation, 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。演示文稿、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均已發佈到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。

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Thanks, Peter. Good morning, everyone, and thank you for joining today's call.

    謝謝,彼得。大家早上好,感謝您加入今天的電話會議。

  • 2021 has been a year of significant achievement and meaningful progress for Merck in the face of what has been a challenging environment for all of us. We deliver on our strategic priorities and took important steps to set a foundation for success in 2022 and beyond.

    面對對我們所有人來說充滿挑戰的環境,2021 年是默克取得重大成就和取得重大進展的一年。我們實現了我們的戰略重點,並採取了重要步驟,為 2022 年及以後的成功奠定了基礎。

  • We achieved strong operational performance, accelerated our broad pipeline, including molnupiravir, completed the spin-off of Organon and acted on key strategic business development activities. We enter 2022 with strong momentum and are pleased to reflect this in our initial revenue and EPS guidance.

    我們取得了強勁的運營業績,加快了包括 molnupiravir 在內的廣泛渠道,完成了 Organon 的分拆,並採取了關鍵的戰略業務發展活動。我們以強勁的勢頭進入 2022 年,並很高興在我們的初始收入和每股收益指導中反映這一點。

  • We continue to evolve with a more focused, more efficient and faster growing company, with an increased urgency to bring forward innovations to address critical unmet needs. This remains the core of our strategy to benefit the patients we serve and, in turn, create long-term value for all stakeholders, including our shareholders.

    我們將繼續與一家更專注、更高效、發展更快的公司一起發展,並越來越迫切地需要提出創新來解決關鍵的未滿足需求。這仍然是我們使我們所服務的患者受益的戰略的核心,進而為包括我們的股東在內的所有利益相關者創造長期價值。

  • Our business achieved strong revenue and earnings growth. Total revenues increased 24% in the quarter and 17% for the full year.

    我們的業務實現了強勁的收入和盈利增長。本季度總收入增長 24%,全年增長 17%。

  • Commercially, we have executed extremely well across all of our key performance drivers, including KEYTRUDA, GARDASIL and Animal Health. We delivered initial molnupiravir shipments to customers around the world, and following the FDA emergency use authorization that was granted in late December made meaningful progress towards our commitment to the U.S. government.

    在商業上,我們在所有關鍵績效驅動因素方面都表現出色,包括 KEYTRUDA、GARDASIL 和 Animal Health。我們向世界各地的客戶交付了初始的莫努匹拉韋,並在 12 月下旬授予 FDA 緊急使用授權後,在我們對美國政府的承諾方面取得了有意義的進展。

  • Our dedicated teams worked diligently, including through the holiday season, to deliver 1.4 million courses of therapy to the United States, United Kingdom and other countries by year-end.

    我們敬業的團隊辛勤工作,包括在假期期間,到年底為美國、英國和其他國家提供了 140 萬個療程。

  • Throughout 2021, we invested in the discovery, development, production and commercialization of medicines and vaccines, furthering the long-term sustainability of our business, all while delivering meaningful operating leverage and strong EPS growth.

    在整個 2021 年,我們投資於藥物和疫苗的發現、開發、生產和商業化,促進了我們業務的長期可持續性,同時提供了有意義的經營槓桿和強勁的每股收益增長。

  • In total, 2021 was a year of strong execution of our strategic priorities across all fronts: operationally, commercially, clinically and financially.

    總的來說,2021 年是我們在各個方面大力執行戰略重點的一年:運營、商業、臨床和財務。

  • As we look at 2022 and out to 2025 and beyond, we expect to achieve continued strong growth. Our oncology portfolio will benefit from the uptake of numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy.

    展望 2022 年和 2025 年及以後,我們預計將實現持續強勁增長。我們的腫瘤學產品組合將受益於最近獲得的眾多批准以及許多其他適應症的預期推出,包括早期治療線。

  • Underlying global demand for GARDASIL remains robust, and further growth will be realized through the investments we are making to increase manufacturing capacity. And our Animal Health business remains very well positioned to grow faster than the market well into the future.

    全球對 GARDASIL 的潛在需求依然強勁,通過我們為提高製造能力而進行的投資將實現進一步增長。我們的動物保健業務在未來仍處於非常有利的位置,能夠以比市場更快的速度增長。

  • Overall, we expect another year of strong revenue growth in 2022. While we will continue to make investments on our pipeline, we are confident that we can achieve a leveraged P&L and significant long-term operating margin expansion.

    總體而言,我們預計 2022 年收入將再次強勁增長。雖然我們將繼續對我們的管道進行投資,但我們有信心實現槓桿化損益和顯著的長期營業利潤率擴張。

  • Longer term, we are intensely focused on successfully navigating the headwind created by likely biosimilar competition to KEYTRUDA at the end of the decade. We aspire to grow through and beyond this period. But at the very least, we will look to minimize the headwind and shorten the time it takes to return to strong growth. We have multiple levers to achieve this task, driving sustained growth well into the next decade.

    從長遠來看,我們非常專注於在本世紀末成功駕馭可能的生物仿製藥競爭對 KEYTRUDA 造成的逆風。我們渴望在此期間成長並超越這一時期。但至少,我們會盡量減少逆風並縮短恢復強勁增長所需的時間。我們有多種手段來完成這項任務,推動未來十年的持續增長。

  • First, we intend to strengthen our leadership in oncology broadly and leverage that position for sustained long-term success. We've done an excellent job of establishing KEYTRUDA as a foundational therapy, and we intend to maximize its opportunity and patient impact. In addition, we have an expanding portfolio of commercial and developmental oncology assets beyond KEYTRUDA, which offer meaningful growth opportunities beyond 2028.

    首先,我們打算廣泛加強我們在腫瘤學領域的領導地位,並利用這一地位實現持續的長期成功。我們在將 KEYTRUDA 確立為基礎療法方面做得非常出色,我們打算最大限度地利用它的機會和對患者的影響。此外,我們在 KEYTRUDA 之外擁有不斷擴大的商業和開發腫瘤學資產組合,為 2028 年以後提供有意義的增長機會。

  • Second, we have many important franchises beyond oncology that we expect can drive durable growth into the next decade, including GARDASIL, which we believe can potentially double by 2030, as well as our pneumococcal portfolio and our Animal Health business, to name a few.

    其次,除了腫瘤學之外,我們還有許多重要的特許經營權,我們預計這些特許經營權可以推動未來十年的持續增長,包括我們認為到 2030 年可能翻倍的 GARDASIL,以及我們的肺炎球菌產品組合和動物保健業務等等。

  • Third, we expect to generate very strong cash flow, which we intend to deploy into value-enhancing business development to augment our pipeline and bring additional drivers of longer-term growth.

    第三,我們預計將產生非常強勁的現金流,我們打算將其部署到增值業務發展中,以增加我們的管道並帶來更多長期增長的驅動力。

  • And fourth, we will advance our internal pipeline and the opportunities we see in vaccines, cardiometabolic, neuroscience and other disease areas. We are making extensive investments in discovery research as well, which we believe will be the source of longer-term innovation.

    第四,我們將推進我們的內部管道和我們在疫苗、心臟代謝、神經科學和其他疾病領域看到的機會。我們還在發現研究方面進行了大量投資,我們相信這將成為長期創新的源泉。

  • As part of our commitment to provide more transparency into these efforts, we will host an investor event focused on our cardiovascular portfolio and pipeline in the spring.

    作為我們為這些努力提供更高透明度的承諾的一部分,我們將在春季舉辦一次投資者活動,重點關注我們的心血管產品組合和管道。

  • In addition to accelerating our internal pipeline, as I noted, a key part of our strategy will be to deploy our cash flow towards value-enhancing business development. We will continue to be appropriately aggressive in pursuing compelling external innovation, and we will supplement our pipeline with an approach that is science-led, but portfolio informed. Last year's acquisitions of Pandion and Acceleron are good examples of our approach.

    正如我所指出的,除了加速我們的內部管道外,我們戰略的一個關鍵部分是將我們的現金流用於提升價值的業務發展。我們將繼續適當積極地追求引人注目的外部創新,並且我們將用一種以科學為主導但以投資組合為基礎的方法來補充我們的管道。去年對 Pandion 和 Acceleron 的收購就是我們方法的一個很好的例子。

  • We are taking calculated risks, and we'll continue to focus on creating value in areas of unmet need. We have the operational capabilities, financial capacity, scientific prowess and sufficient runway before the end of the decade for business development to play an important role in our goal of achieving long-term sustainable growth. While we have a strong track record of business development, we know we need to do more.

    我們正在承擔經過計算的風險,我們將繼續專注於在未滿足需求的領域創造價值。我們擁有運營能力、財務能力、科學實力和充足的跑道,在十年結束前為業務發展發揮重要作用,實現長期可持續增長的目標。雖然我們在業務發展方面擁有良好的記錄,但我們知道我們需要做更多的事情。

  • Finally, we've taken further steps to integrate important environmental, social and governance goals into the core of our business. In December, we completed the inaugural issuance of a $1 billion sustainability bond. We intend to use the net proceeds to support projects and partnerships in the company's priority ESG areas and to contribute to the advancement of United Nations Sustainability Development Goals.

    最後,我們採取了進一步措施,將重要的環境、社會和治理目標整合到我們業務的核心中。 12 月,我們完成了 10 億美元可持續發展債券的首次發行。我們打算將所得款項淨額用於支持公司優先 ESG 領域的項目和合作夥伴關係,並為推進聯合國可持續發展目標做出貢獻。

  • We've also acted to accelerate global access for molnupiravir through our groundbreaking access strategy, including a recent agreement with UNICEF for up to 3 million courses of therapy to supplement supply available for distribution in low- and middle-income countries.

    我們還通過我們開創性的獲取戰略加快了莫努匹韋的全球獲取,包括最近與聯合國兒童基金會達成的一項協議,提供多達 300 萬個療程,以補充可供中低收入國家分銷的供應。

  • In addition, this morning, we announced plans to host our initial ESG investor event on February 23. We believe that strong performance across key ESG metrics aligns well with Merck's core values and mission, and we look forward to providing insights into our commitment to this space.

    此外,今天上午,我們宣布計劃於 2 月 23 日舉辦首次 ESG 投資者活動。我們認為,關鍵 ESG 指標的強勁表現與默克的核心價值觀和使命非常吻合,我們期待提供有關我們對此承諾的見解空間。

  • Now before I turn the call over to Caroline, I want to take a moment to recognize Frank Clyburn. Following 14 years of significant contributions, Frank will be leaving Merck to become CEO of IFF. I want to thank Frank for the strategic vision and operational excellence he has provided in helping establish Merck as a global leader in oncology and for his strong leadership of our Human Health business.

    現在,在我將電話轉給 Caroline 之前,我想花點時間認識一下 Frank Clyburn。經過 14 年的重大貢獻,弗蘭克將離開默克,成為 IFF 的首席執行官。我要感謝弗蘭克提供的戰略遠見和卓越運營,幫助默克公司成為腫瘤學領域的全球領導者,並感謝他對我們人類健康業務的強有力領導。

  • We wish Frank and his family all the best as he embarks on his new endeavor. While Frank will be missed, we are well positioned to continue our strong momentum with the deep and talented team we have in place, and we expect to announce new leaders shortly.

    我們祝愿弗蘭克和他的家人在他開始新的事業時一切順利。雖然會想念弗蘭克,但我們有能力通過我們現有的深厚而才華橫溢的團隊繼續保持強勁勢頭,我們預計很快就會宣布新的領導人。

  • With that, I'll pass it over to Caroline to provide details into the performance of our business as well as our financial results and outlook. Caroline?

    有了這個,我將把它交給 Caroline,以提供有關我們業務表現以及我們的財務業績和前景的詳細信息。卡羅琳?

  • Caroline Litchfield - Executive VP & CFO

    Caroline Litchfield - Executive VP & CFO

  • Thank you, Rob. Good morning.

    謝謝你,羅布。早上好。

  • 2021 was a year of exceptional performance for our business. We drove robust top line growth of 17% and bottom line growth of 33%. Our teams performed with agility and executed with excellence, despite challenges from the ongoing pandemic.

    2021 年是我們業務表現出色的一年。我們推動了 17% 的強勁收入增長和 33% 的利潤增長。儘管面臨持續大流行的挑戰,我們的團隊仍以敏捷的方式執行並出色地執行。

  • We are also very proud of the significant efforts to bring monotherapy to patients worldwide. These results reinforce the confidence we have in our science-led strategy and in our outlook for strong growth. We will continue to invest in our portfolio and pipeline as well as in business development to maximize growth over the near and long term and to create value for patients and shareholders.

    我們也為為全球患者帶來單一療法而做出的重大努力感到非常自豪。這些結果增強了我們對以科學為主導的戰略和強勁增長前景的信心。我們將繼續投資於我們的投資組合和管道以及業務發展,以最大限度地提高近期和長期的增長,並為患者和股東創造價值。

  • Now turning to our fourth quarter results. Total company revenues were $13.5 billion, an increase of 24% or 23% excluding the impacts of foreign exchange. Molnupiravir contributed $952 million in revenue or 9 percentage points of growth. The remainder of my comments will be on an ex-exchange basis.

    現在轉向我們的第四季度業績。公司總收入為 135 億美元,扣除外匯影響後增長 24% 或 23%。 Molnupiravir 貢獻了 9.52 億美元的收入或 9 個百分點的增長。我的其餘評論將以交換為基礎。

  • Our Human Health business continued its strong momentum, growing 23%, driven by our key pillars and contribution from molnupiravir. Our Animal Health business also delivered robust performance, with sales increasing 8%, driven by companion animal products.

    在我們的主要支柱和莫努匹韋的貢獻的推動下,我們的人類健康業務繼續保持強勁勢頭,增長 23%。我們的動物保健業務也表現強勁,在伴侶動物產品的推動下銷售額增長了 8%。

  • Now turning to the fourth quarter performance of our key brands. In oncology, KEYTRUDA grew 16% to $4.6 billion, reflecting continued robust global demand. In the U.S., KEYTRUDA continues to demonstrate durable momentum across all key tumors and is benefiting from the recent launches in neoadjuvant and adjuvant triple-negative breast cancer, renal cell carcinoma and in cervical cancer.

    現在轉向我們主要品牌的第四季度業績。在腫瘤領域, KEYTRUDA 增長 16% 至 46 億美元,反映出全球需求持續強勁。在美國, KEYTRUDA 繼續在所有關鍵腫瘤中顯示出持久的勢頭,並受益於最近在新輔助和輔助三陰性乳腺癌、腎細胞癌和宮頸癌方面的推出。

  • KEYTRUDA continues to extend its strong IO top leadership and maintain its position in non-small cell lung cancer, capturing 8 out of 10 eligible new patients, despite competition. Outside the U.S., KEYTRUDA growth continues to be driven by lung cancer and the ongoing launches in head and neck and RCC.

    KEYTRUDA 繼續擴大其強大的 IO 最高領導地位,並保持其在非小細胞肺癌領域的地位,儘管存在競爭,但仍能在 10 名符合條件的新患者中獲得 8 名。在美國以外, KEYTRUDA 的增長繼續受到肺癌以及頭頸部和 RCC 的持續推出的推動。

  • We continue to expand our reach into earlier lines. We were very pleased to receive 2 additional adjuvant approvals this quarter in RCC and in melanoma. With these approvals, KEYTRUDA has now received 5 indications in earlier-stage cancers.

    我們繼續將我們的業務範圍擴大到更早的產品線。我們很高興本季度在 RCC 和黑色素瘤中獲得了 2 項額外的佐劑批准。有了這些批准, KEYTRUDA 現在已經收到了 5 個早期癌症的適應症。

  • If approved, we also look forward to expanding into adjuvant lung cancer, following the encouraging top line results from the KEYNOTE-091 trial. We are confident that, along with strong clinical data, KEYTRUDA's reputation and familiarity among physicians will be a benefit as we move into early-stage disease.

    如果獲得批准,我們也期待在 KEYNOTE-091 試驗令人鼓舞的一線結果之後擴展到輔助肺癌。我們相信,隨著強大的臨床數據, KEYTRUDA 在醫生中的聲譽和熟悉度將在我們進入早期疾病時受益。

  • Lynparza remains the market-leading PARP inhibitor. Growth of 33% was driven by our breast cancer indication and continued uptake of the most recent indications, including prostate. Our expected launch in a broader prostate population based on the PROpel trial represents a significant opportunity.

    Lynparza 仍然是市場領先的 PARP 抑製劑。 33% 的增長是由我們的乳腺癌適應症和對包括前列腺在內的最新適應症的持續吸收推動的。我們基於 PROpel 試驗在更廣泛的前列腺人群中的預期推出代表了一個重要的機會。

  • Lenvima sales grew 31% driven by RCC and endometrial cancer in the U.S. We have seen very encouraging early trends in new patient share following the launch of KEYNOTE-581 in first-line RCC.

    在美國 RCC 和子宮內膜癌的推動下, Lenvima 的銷售額增長了 31%。在一線 RCC 推出 KEYNOTE-581後,我們看到新患者份額的早期趨勢非常令人鼓舞。

  • We are also excited by the recent launch of WELIREG for patients with certain VHL-associated tumors. WELIREG continues to generate strong interest among scientific leaders, providers and patients and is off to a promising start. We expect to extend its reach to broader RCC indications in the future.

    我們也對最近為患有某些 VHL 相關腫瘤的患者推出的 WELIREG 感到興奮。 WELIREG 繼續引起科學領導者、提供者和患者的濃厚興趣,並取得了良好的開端。我們希望在未來將其範圍擴大到更廣泛的 RCC 適應症。

  • Our Vaccines portfolio again delivered strong growth driven by GARDASIL, which grew 50% to $1.5 billion and nearly 40% for the full year. Outside the U.S., robust growth was driven by strong underlying demand across all key geographies, particularly China as well as increased supply. This growth more than offset the decline in the U.S. due to timing of CDC purchases as well as the replenishment of the CDC stockpile in the fourth quarter of 2020.

    在 GARDASIL 的推動下,我們的疫苗產品組合再次實現強勁增長,增長 50% 至 15 億美元,全年增長近 40%。在美國以外,強勁的增長是由所有主要地區(尤其是中國)的強勁潛在需求以及供應增加推動的。由於 CDC 購買時機以及 2020 年第四季度 CDC 庫存的補充,這一增長足以抵消美國的下降。

  • Also impacting HPV immunization levels was the prioritization of COVID vaccinations in younger age cohorts. Underlying global demand for GARDASIL remains strong, as it is increasingly being recognized as a vaccine that can help prevent certain HPV-related cancers in both female and male.

    影響 HPV 免疫水平的還有年輕人群中 COVID 疫苗接種的優先級。全球對 GARDASIL 的潛在需求仍然強勁,因為它越來越被認為是一種可以幫助預防女性和男性發生某些與 HPV 相關的癌症的疫苗。

  • In our hospital acute care portfolio, BRIDION sales grew 24% driven by increased usage of neuromuscular blockade reversal agents and BRIDION's growing share within the class.

    在我們的醫院急症護理產品組合中,BRIDION 的銷售額增長了 24%,這得益於神經肌肉阻滯逆轉劑使用量的增加以及 BRIDION 在同類產品中的份額不斷增長。

  • Our Animal Health business delivered another quarter of strong growth, with sales increasing 8%. Companion animal sales increased 26% driven by global demand in parasiticides, including the BRAVECTO line of products, as well as vaccines.

    我們的動物保健業務實現了又一個季度的強勁增長,銷售額增長了 8%。由於全球對殺蟲劑的需求,包括 BRAVECTO 系列產品以及疫苗,伴侶動物的銷售額增長了 26%。

  • Recall that we experienced changes in distributor purchasing patterns, which negatively impacted last year's results. Livestock sales were flat, as strong global demand for poultry and swine products was offset by a difficult year-over-year comparison due to the recording of an extra month of sales relating to Antelliq in the fourth quarter of 2020.

    回想一下,我們經歷了分銷商採購模式的變化,這對去年的業績產生了負面影響。牲畜銷售持平,因為全球對家禽和豬產品的強勁需求被艱難的同比比較所抵消,原因是 2020 年第四季度與 Antelliq 相關的銷售額增加了一個月。

  • 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 74.8%, a decrease of 0.2 percentage points. As a reminder, we share profits from molnupiravir equally with our partner, Ridgeback, which is reflected within cost of sales and reduces our gross margin. This impact was largely offset by favorable mix and lower discards.

    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74.8%,下降0.2個百分點。提醒一下,我們與我們的合作夥伴 Ridgeback 平等分享來自 molnupiravir 的利潤,這反映在銷售成本中並降低了我們的毛利率。這種影響在很大程度上被有利的組合和較低的丟棄物所抵消。

  • Operating expenses increased 3% to $5.3 billion as we continued to invest behind our growth drivers and pipeline. Other expense was approximately $50 million.

    由於我們繼續投資於我們的增長動力和管道,運營費用增加了 3% 至 53 億美元。其他費用約為 5000 萬美元。

  • Our full year tax rate was 11.2%, which is lower than our prior guidance due to a more favorable mix of income and expense than previously estimated. The effective tax rate for the fourth quarter of 4.3% reflects the impacts of the lower full year rate as well as foreign tax credit. Taken together, we earned $1.80 per share.

    我們的全年稅率為 11.2%,低於我們之前的指導,因為收入和支出的組合比之前估計的更有利。第四季度的有效稅率為 4.3%,反映了較低的全年稅率以及外國稅收抵免的影響。合起來,我們每股賺了 1.80 美元。

  • It is worth noting that our underlying operating results were toward the upper end of our expectations and the contributions from molnupiravir, and the favorable tax rate resulted in EPS that exceeded our prior guidance.

    值得注意的是,我們的基本經營業績接近我們預期的上限和莫努匹韋的貢獻,優惠的稅率導致每股收益超過了我們之前的指導。

  • Turning now to our 2022 non-GAAP guidance. We believe the strong underlying momentum in our business will continue, and we will also benefit from increased molnupiravir revenues. We expect revenue to be between $56.1 billion and $57.6 billion, representing growth of 15% to 18%, including a negative impact from foreign exchange of approximately 2% using mid-January rates.

    現在轉向我們的 2022 年非 GAAP 指導。我們相信我們業務的強勁潛在勢頭將繼續,我們也將受益於莫努匹韋收入的增加。我們預計收入將在 561 億美元至 576 億美元之間,增長 15% 至 18%,其中包括按 1 月中旬匯率計算的約 2% 的外匯負面影響。

  • Our gross margin is expected to be approximately 74%. We expect operating expenses to grow at a mid- to high single-digit rate driven in part by the addition of R&D expenses related to the Acceleron acquisition.

    我們的毛利率預計約為 74%。我們預計運營費用將以中高個位數的速度增長,部分原因是與收購 Acceleron 相關的研發費用增加。

  • In other income and expense, we expect expense of approximately $350 million. We assume a full year tax rate between 13% and 14%. We assume 2.53 billion shares outstanding. Taken together, we expect EPS of $7.12 to $7.27, reflecting growth of 18% to 21%. This range includes the negative impact from foreign exchange of approximately 1% using mid-January rates.

    在其他收入和支出方面,我們預計支出約為 3.5 億美元。我們假設全年稅率在 13% 到 14% 之間。我們假設流通股為 25.3 億股。綜合來看,我們預計每股收益為 7.12 美元至 7.27 美元,反映 18% 至 21% 的增長。該範圍包括使用 1 月中旬匯率約 1% 的外匯負面影響。

  • As you consider your models, there are a few areas to focus on. First, on molnupiravir, we are excited by our regulatory authorizations to date and believe molnupiravir will be an important treatment option to combat the ongoing pandemic. We have announced a number of supply and purchase agreements, providing approximately 10 million courses of therapy. Based on agreements now in place, we are confident in our ability to achieve $5 billion to $6 billion in revenues in 2022, weighted to the first half of the year.

    在考慮模型時,有幾個方面需要關注。首先,關於 molnupiravir,我們對迄今為止的監管授權感到興奮,並相信 molnupiravir 將成為對抗持續流行病的重要治療選擇。我們宣布了多項供應和採購協議,提供約 1000 萬個療程。根據現有協議,我們有信心在 2022 年實現 50 億至 60 億美元的收入,加權到今年上半年。

  • Next, we expect continued strong growth of KEYTRUDA, which should benefit from increased expansion in ex-U.S. market and the continued ramp of recent launches globally.

    接下來,我們預計 KEYTRUDA 將繼續強勁增長,這將受益於美國以外地區的擴張。市場以及最近在全球範圍內推出的持續增長。

  • On GARDASIL, we continue to expect robust demand, along with increased supply to drive strong year-over-year growth, albeit not at the same pace as in 2021. In the U.S., increased uptake in the mid adult cohort as well as catch-up from missed doses due to the pandemic will drive growth.

    在 GARDASIL 方面,我們繼續預計強勁的需求以及增加的供應將推動強勁的同比增長,儘管速度與 2021 年不同。在美國,中成人群體的吸收增加以及捕獲量增加由於大流行而錯過的劑量將推動增長。

  • Outside the U.S., we continue to expect strong demand across regions particularly in China and from a relaunch in Japan. Global HPV vaccination levels remain low, and we continue to believe GARDASIL's opportunity for growth is significant.

    在美國以外,我們繼續預計各地區的需求強勁,尤其是中國和日本的重新啟動。全球 HPV 疫苗接種水平仍然很低,我們繼續相信 GARDASIL 的增長機會是巨大的。

  • In pneumococcal, we are excited by the recent launch of VAXNEUVANCE in adults and the potential opportunity for approval in pediatric, which represents a larger portion of the pneumococcal market. We expect some offset however from the impact to U.S. sales of PNEUMOVAX 23 as the market continues to shift towards newer pneumococcal conjugate vaccines.

    在肺炎球菌方面,我們對最近在成人中推出 VAXNEUVANCE 以及在兒科中獲得批准的潛在機會感到興奮,這代表了肺炎球菌市場的較大部分。然而,隨著市場繼續轉向更新的肺炎球菌結合疫苗,我們預計 PNEUMOVAX 23對美國銷售的影響會有所抵消。

  • We also expect to experience modest LOE pressure on JANUVIA in the second half of 2022, as we lose exclusivity in some of the larger ex-U.S. market.

    我們還預計 2022 年下半年 JANUVIA 將面臨適度的 LOE 壓力,因為我們在一些較大的美國以外地區失去了排他性。市場。

  • For Animal Health, given our broad and innovative portfolio, we are well positioned to again drive above-market growth in 2022 and beyond.

    對於動物保健,鑑於我們廣泛而創新的產品組合,我們有能力在 2022 年及以後再次推動高於市場的增長。

  • Finally, as we look out to 2025, we remain confident in our ability to achieve strong revenue growth driven largely by our derisked portfolio and operating margin in excess of 43%. Our capital allocation priorities remain unchanged.

    最後,展望 2025 年,我們仍然對實現強勁收入增長的能力充滿信心,這主要得益於我們的低風險投資組合和超過 43% 的營業利潤率。我們的資本配置重點保持不變。

  • First, we will continue to prioritize investments in our business and pipeline to drive near- and long-term growth. We also continue to augment our internal pipeline through strategic business development. We were active in 2021, including the acquisitions of Acceleron and Pandion, and we intend to pursue additional value-enhancing opportunities.

    首先,我們將繼續優先投資於我們的業務和管道,以推動近期和長期增長。我們還通過戰略業務發展繼續擴大我們的內部管道。我們在 2021 年很活躍,包括收購 Acceleron 和 Pandion,我們打算尋求更多的增值機會。

  • We remain committed to the dividend with the goal of increasing it over time. To the extent we have excess cash, we will return it to shareholders through share repurchases.

    我們仍然致力於股息,目標是隨著時間的推移增加股息。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, our growth in the fourth quarter underscores our confidence in the underlying strength of our business and in the global demand of our innovative medicines and vaccines. We remain in a position of financial and operational strength, and our continued execution will enable us to deliver on that promise now and well into the future.

    總而言之,我們在第四季度的增長突顯了我們對我們業務的潛在實力以及對我們創新藥物和疫苗的全球需求的信心。我們仍處於財務和運營實力的地位,我們的持續執行將使我們能夠在現在和未來兌現這一承諾。

  • 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。

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Thank you, Caroline. Good morning, everyone. I will provide a brief summary of notable achievements in 2021 and then report on progress since the last earnings call.

    謝謝你,卡羅琳。大家,早安。我將簡要總結 2021 年的顯著成就,然後報告自上次財報電話會議以來的進展情況。

  • In 2021, we made meaningful advancements across our broader pipeline with approvals for new molecular entities, including VAXNEUVANCE, VERQUVO and WELIREG, and an EUA for molnupiravir. We also made strides in women's cancers with U.S. regulatory approvals for KEYTRUDA in cervical, endometrial and triple-negative breast cancer.

    2021 年,我們在更廣泛的管道中取得了有意義的進展,批准了新的分子實體,包括 VAXNEUVANCE、VERQUVO 和 WELIREG,以及用於 molnupiravir 的 EUA。 KEYTRUDA 在宮頸癌、子宮內膜癌和三陰性乳腺癌中的應用獲得美國監管部門的批准,我們在女性癌症方面也取得了長足的進步。

  • In total, we received more than 30 approvals and filed more than 20 NDAs and SBLAs in the United States, EU, Japan and China. In 2022, we look to build on this progress and momentum.

    我們總共在美國、歐盟、日本和中國獲得了 30 多項批准,並提交了 20 多項 NDA 和 SBLA。 2022 年,我們希望在這一進展和勢頭的基礎上再接再厲。

  • I will now cover notable regulatory milestones and clinical updates for our molnupiravir , oncology, pneumococcal, HIV and cardiovascular programs. As we enter the third year of the pandemic, the Omicron variant continues to reap havoc on our communities and health care systems. In the United States alone, we are now seeing approximately 2,000 deaths a day. Vaccines and treatment options have the potential to help combat this pandemic.

    我現在將介紹我們的 molnupiravir 、腫瘤學、肺炎球菌、艾滋病毒和心血管項目的顯著監管里程碑和臨床更新。隨著我們進入大流行的第三個年頭,Omicron 變種繼續對我們的社區和醫療保健系統造成嚴重破壞。僅在美國,我們現在每天就看到大約 2,000 人死亡。疫苗和治療方案有可能幫助對抗這種流行病。

  • Since the first authorization for molnupiravir by the U.K. in November, we have received authorizations in 9 additional countries, including an emergency use authorization in the United States and a special approval for emergency in Japan. In addition, other countries have provided authorizations to our voluntary license holders.

    自 11 月英國首次批准莫努匹韋以來,我們已在另外 9 個國家獲得授權,包括美國的緊急使用授權和日本的緊急特別批准。此外,其他國家也向我們的自願許可證持有者提供了授權。

  • Findings from the MOVe-OUT clinical trial published in the New England Journal of Medicine at the end of last year showed molnupiravir significantly reduced hospitalization or death in adult patients most in danger of progressing to severe disease. Importantly, for physicians and patients, approximately 90% fewer deaths were seen in those taking molnupiravir. These results reinforce that molnupiravir provide an important oral treatment option for certain adults at high risk for severe illnesses.

    去年底發表在《新英格蘭醫學雜誌》上的 MOVe-OUT 臨床試驗結果顯示,莫努匹拉韋顯著降低了最有可能發展為嚴重疾病的成年患者的住院或死亡。重要的是,對於醫生和患者來說,服用莫努匹韋的人死亡人數減少了大約 90%。這些結果強化了莫努匹韋為某些患有嚴重疾病高風險的成年人提供了一種重要的口服治療選擇。

  • The Director of the United States CDC has indicated the need to prioritize therapeutic interventions for people with the highest risk of progression, such as those with certain comorbidities. We believe molnupiravir has a low propensity for drug-drug interactions, make it a meaningful and important option for appropriate patients with COVID-19 who are receiving treatments for underlying conditions, such as heart disease, hypertension and diabetes, and for those with impaired liver or kidney function, consistent with local recommendations.

    美國疾病預防控制中心主任表示,有必要優先針對進展風險最高的人(例如患有某些合併症的人)進行治療干預。我們認為,莫努匹韋的藥物-藥物相互作用傾向較低,因此對於正在接受心髒病、高血壓和糖尿病等潛在疾病治療的適當 COVID-19 患者以及肝功能受損的患者來說,它是一個有意義且重要的選擇或腎功能,符合當地建議。

  • To date, this pandemic has consisted of successive waves of SARS-CoV-2 variants, most recently, Omicron. Last week, we announced data from multiple independent studies indicating that molnupiravir is active against the Omicron variant in vitro.

    迄今為止,這場大流行包括連續波的 SARS-CoV-2 變體,最近的是 Omicron。上週,我們公佈了多項獨立研究的數據,表明莫努匹韋在體外對 Omicron 變體具有活性。

  • Each surge comes with distinct public health and disease characteristics and corresponding treatment and prevention challenges. The potential threat of rapidly emerging variants reinforces the need for treatment options with high barrier to resistance that target ever solutionarily conserved aspects of viral biology.

    每次激增都伴隨著明顯的公共衛生和疾病特徵以及相應的治療和預防挑戰。快速出現的變體的潛在威脅加強了對具有高抗性障礙的治療選擇的需求,這些治療選擇針對病毒生物學的解決方案保守的方面。

  • Recognizing the importance of an oral antiviral, we committed to manufacturing molnupiravir and have it ready for supply to patients within the U.S. upon emergency use authorization. As Caroline noted, we were able to fulfill that promise and ensure delivery of this important treatment. We are working with governments and partners around the globe to stay ahead of the curve and to further Merck's contribution in fighting this pandemic.

    認識到口服抗病毒藥物的重要性,我們致力於生產 molnupiravir,並在獲得緊急使用授權後準備好供應給美國境內的患者。正如 Caroline 所說,我們能夠兌現這一承諾並確保提供這一重要治療。我們正在與全球各國政府和合作夥伴合作,以保持領先地位,並進一步推動默克在抗擊這一流行病方面的貢獻。

  • Next, we continue to fortify our position in oncology. Several recent milestones highlight our strategy of targeting earlier-stage cancers where there is potential for improved outcomes by reducing risk of recurrence. We received FDA and European Commission approval for KEYTRUDA in the adjuvant setting for renal cell carcinoma and FDA approval for certain stages of melanoma.

    接下來,我們將繼續鞏固我們在腫瘤學領域的地位。最近的幾個里程碑突出了我們針對早期癌症的戰略,這些癌症有可能通過降低復發風險來改善結果。我們獲得了 FDA 和歐盟委員會對 KEYTRUDA 用於腎細胞癌輔助治療的批准,以及 FDA 對某些階段黑色素瘤的批准。

  • In RCC, approval was based on KEYNOTE-564. KEYTRUDA is the first and only immunotherapy treatment option for certain patients at intermediate high or high risk of recurrence in the adjuvant setting.

    在 RCC 中,批准基於 KEYNOTE-564。 KEYTRUDA 是針對某些在輔助環境中處於中高或高複發風險的患者的第一個也是唯一的免疫療法治療選擇。

  • And in melanoma, the approval was based on KEYNOTE-716 and provides for the adjuvant treatment of patients 12 years and older with Stage IIb and IIc disease following complete resection. Both approvals provide patients with important new options shown to help reduce the risk of recurrence.

    在黑色素瘤中,該批准基於 KEYNOTE-716,並為 12 歲及以上的 IIb 期和 IIc 期疾病患者在完全切除後提供輔助治療。這兩項批准都為患者提供了重要的新選擇,有助於降低復發風險。

  • Similarly, we recently announced a positive finding from the KEYNOTE-091 or PEARLS study, evaluating KEYTRUDA as adjuvant treatment for patients with Stage Ib to IIIa non-small cell lung cancer following surgical resection. At an interim analysis, the trial met one of its dual primary endpoints, demonstrating a statistically significant improvement in disease-free survival in all [corners] when treated with KEYTRUDA compared to placebo.

    同樣,我們最近宣布了 KEYNOTE-091 或 PEARLS 研究的積極發現,評估 KEYTRUDA 作為手術切除術後 Ib 至 IIIa 期非小細胞肺癌患者的輔助治療。在一項中期分析中,該試驗達到了其雙重主要終點之一,表明與安慰劑相比,使用 KEYTRUDA 治療時所有[角落]的無病生存率都有統計學意義的改善。

  • The trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1, the other dual primary endpoint, which did not meet statistical significance at the time of the planned interim analysis, as well as overall survival, a key secondary endpoint.

    該試驗將繼續分析腫瘤表達高水平 PD-L1 的患者的 DFS,另一個雙重主要終點,在計劃的中期分析時不符合統計學意義,以及總生存期,一個關鍵的次要終點.

  • We are continuing to make progress in women's cancer based on data from the Phase III OlympiA trial. The FDA granted priority review for Lynparza for the adjuvant treatment of patients with BRCA-mutated HER2-negative, high-risk early breast cancer previously treated with chemotherapy, either before or after surgery. We anticipate FDA action during the first quarter of 2022.

    根據 III 期 OlympiA 試驗的數據,我們將繼續在女性癌症方面取得進展。 FDA 授予了 Lynparza 的優先審查權,用於輔助治療 BRCA 突變的 HER2 陰性、高風險早期乳腺癌患者,該患者之前接受過化療,無論是手術前還是手術後。我們預計 FDA 將在 2022 年第一季度採取行動。

  • Moving to the broader portfolio. The FDA issued a complete response letter for the new drug applications for gefapixant and have requested additional information related to the measurement of efficacy. There were no safety concerns for gefapixant, and we will continue with the FDA to discuss next steps as we look to address the significant unmet need in patients with chronic cough.

    轉向更廣泛的投資組合。 FDA 就吉法匹鬆的新藥申請發出了完整的回复信,並要求提供與療效測量相關的更多信息。 gefapixant 沒有安全問題,我們將繼續與 FDA 討論下一步措施,以解決慢性咳嗽患者的重大未滿足需求。

  • In Japan, we are pleased to announce the Ministry of Health, Labor and Welfare approved Lyfnua, the trademark for gefapixant, for adults with refractory or unexplained chronic cough.

    在日本,我們很高興地宣布,日本厚生勞動省批准了 Gefapixant 的商標 Lyfnua 用於成人難治性或不明原因慢性咳嗽。

  • Momentum continues in our pneumococcal disease program, following the U.S. approval in July 2021. The European Commission approved VAXNEUVANCE in individuals 18 years of age and older in December. Also in December, we announced the FDA granted priority review of our supplemental application for VAXNEUVANCE in the pediatric setting.

    在美國於 2021 年 7 月獲得批准後,我們的肺炎球菌疾病項目繼續保持勢頭。歐盟委員會於 12 月批准了 VAXNEUVANCE 用於 18 歲及以上的個人。同樣在 12 月,我們宣布 FDA 批准了我們在兒科環境中的 VAXNEUVANCE 補充申請的優先審查。

  • Importantly, VAXNEUVANCE incorporates serotypes 22F and 33F and provides robust response on other key disease-causing serotypes, like serotype 3, therefore, offering the potential to prevent additional invasive disease in children. We anticipate regulatory action in the spring of this year.

    重要的是,VAXNEUVANCE 結合了血清型 22F 和 33F,並對其他關鍵的致病血清型(如血清型 3)提供了強有力的反應,因此,提供了預防兒童其他侵襲性疾病的潛力。我們預計今年春季將採取監管行動。

  • Merck has a proud legacy of HIV research, and we remain committed to those impacted by this virus. Following the announcement of the FDA clinical hold for ongoing trials evaluating islatravir, we are working to understand the data and the principles of the finding. We believe in the potential of the nucleoside reverse transcriptase and translocation inhibitor mechanism for both the prevention and treatment of HIV, and we intend to share updates in the future.

    默克在 HIV 研究方面擁有引以為豪的遺產,我們仍然致力於為受這種病毒影響的人們提供幫助。在 FDA 宣布對正在進行的評估 islatravir 的試驗進行臨床暫停後,我們正在努力了解數據和發現的原則。我們相信核苷逆轉錄酶和易位抑製劑機制在預防和治療 HIV 方面的潛力,我們打算在未來分享更新。

  • Looking across our broader pipeline. As Rob noted, in the fourth quarter, we completed the acquisition of Acceleron. Its lead candidate, sotatercept, is an excellent complement to our pipeline and has the potential to provide a novel approach to treating pulmonary arterial hypertension. The integration is proceeding according to plan, and the Phase III program is on track. We plan to provide further details on our cardiovascular pipeline at an investor event in the spring.

    縱觀我們更廣泛的管道。正如 Rob 所說,在第四季度,我們完成了對 Acceleron 的收購。它的主要候選藥物 sotatercept 是對我們產品線的極好補充,並有可能提供一種治療肺動脈高壓的新方法。整合正在按計劃進行,三期項目正在按計劃進行。我們計劃在春季的一次投資者活動中提供有關我們心血管管道的更多詳細信息。

  • In closing, 2021 was a tremendous year where we demonstrate our ability to advance both our internal and external pipelines. We are well positioned to continue our momentum into 2022 with a dual focus, becoming the leading oncology company by 2025 and sustaining that position beyond 2028, while also extending our impact across other therapeutic areas. I look forward to providing further updates in the coming year.

    最後,2021 年是偉大的一年,我們展示了我們推進內部和外部管道的能力。我們有能力將我們的勢頭延續到 2022 年,並以雙重重點,到 2025 年成為領先的腫瘤學公司,並在 2028 年之後保持這一地位,同時還將我們的影響力擴展到其他治療領域。我期待在來年提供進一步的更新。

  • Now I turn the call back to Peter.

    現在我把電話轉回給彼得。

  • Peter Dannenbaum - VP of IR

    Peter Dannenbaum - VP of IR

  • Thank you, Dean. Grace, would you please start the Q&A? (Operator Instructions) Thank you.

    謝謝你,院長。格蕾絲,你能開始問答嗎? (操作員說明)謝謝。

  • Operator

    Operator

  • (Operator Instructions) Your first question comes from the line of Geoff Meacham from Bank of America.

    (操作員說明)您的第一個問題來自美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • I guess, one for Dean or for Rob. How strategically important is molnupiravir? Is the goal to maximize the revenue this year, assuming that resistance doesn't emerge? Or are you guys making investments in a potential combination to turn this business into maybe a longer contributor?

    我猜,一個給迪恩或羅布。莫努匹韋的戰略重要性如何?假設沒有出現阻力,今年的目標是最大化收入嗎?或者你們是否正在對潛在的組合進行投資,以將這項業務轉變為可能更長的貢獻者?

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Yes. Geoff, thanks for the question. So as we look at molnupiravir, obviously, you heard from Caroline the guidance we're giving for this year, but I think you've hit upon an important point, which we do see the potential for molnupiravir beyond the current situation with COVID-19 and the pandemic given the fact that it does have such good activity more broadly in RNA viruses.

    是的。傑夫,謝謝你的問題。因此,當我們研究莫努匹拉韋時,顯然,您從卡羅琳那裡聽到了我們今年提供的指導,但我認為您已經找到了一個重要的觀點,我們確實看到莫努匹拉韋的潛力超出了目前的 COVID- 19 和大流行,因為它確實在 RNA 病毒中具有更廣泛的良好活性。

  • And as we believe, it can be pan-coronavirus effective. And as we showed recently with 6 preclinical studies, working well against the Omicron variant, and we believe we'll continue to work against future variants.

    正如我們所相信的那樣,它可以對泛冠狀病毒有效。正如我們最近通過 6 項臨床前研究所展示的那樣,它們對 Omicron 變體效果很好,我們相信我們將繼續針對未來的變體進行工作。

  • But maybe I'll turn it over to Dean to expand upon what we're thinking about from a developmental perspective for longer term.

    但也許我會把它交給迪恩,以從長遠的發展角度擴展我們正在考慮的事情。

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Yes. So if I may, let's just frame how many deaths we have a day in the United States. I mean, it's quite staggering where we are at this point. And I would just emphasize, molnupiravir is an oral drug as all know. It's effective in reducing hospitalization and death.

    是的。因此,如果可以的話,讓我們計算一下美國一天有多少人死亡。我的意思是,我們目前所處的位置非常驚人。我只想強調,眾所周知,莫努匹韋是一種口服藥物。它可有效減少住院和死亡。

  • And I really think, when we think about the death rate in the United States and throughout, having access to medicines that can reduce mortality greater than 80%, 85%, 90% is going to be really important. And molnupiravir is one of such drugs that can do that, and I think that needs to be sort of emphasized throughout.

    我真的認為,當我們考慮美國和整個美國的死亡率時,能夠獲得可以將死亡率降低超過 80%、85%、90% 的藥物將非常重要。莫努匹拉韋就是可以做到這一點的藥物之一,我認為這需要在整個過程中得到強調。

  • Now in relationship to molnupiravir directly, those people who we have to be concerned about drug-drug interactions or renal insufficiency or liver insufficiency are often those people at the highest risk. And the fact that molnupiravir has a profile that is really useful in those patients is important.

    現在直接與莫努匹韋有關,我們必須關注藥物-藥物相互作用或腎功能不全或肝功能不全的人通常是風險最高的人。莫努匹拉韋具有對這些患者真正有用的特徵這一事實很重要。

  • I do want to emphasize that by first principle, the whole mechanism and the molecule is designed to be as variant proof as can be theoretically possible. And what we've seen with the Omicron and potentially what we will see with other variants is that theoretical becomes real. With Omicron, for example, all of a sudden, there's a series of antibody treatments that are no longer effective.

    我確實想強調,根據第一原則,整個機制和分子被設計為盡可能理論上可能的變體證明。我們在 Omicron 上看到的以及我們在其他變體中可能看到的是理論變為現實。以 Omicron 為例,突然之間,一系列抗體治療不再有效。

  • And then the other point that I would make is when we sent our EUA in October, we also held hands that we would be able to produce, supply, distribute this drug immediately. And I think that's been shown that when we sent our EUA in October, we were in that position. And we demonstrated when we got an EUA in late December how fast we could distribute.

    然後我要說的另一點是,當我們在 10 月份發送 EUA 時,我們還手握著手,我們將能夠立即生產、供應和分發這種藥物。我認為這已經表明,當我們在 10 月份發送 EUA 時,我們就處於那個位置。當我們在 12 月下旬獲得 EUA 時,我們展示了我們可以以多快的速度分發。

  • And I just want to emphasize that I think that when one looks at the death rate when we sent in our EUA and what the death rate now is, it's threefold higher. So I just want to emphasize that.

    我只想強調,我認為當我們看到我們發送 EUA 時的死亡率和現在的死亡率時,它高出三倍。所以我只想強調這一點。

  • When you think about the future, I suppose there is different bookends with one can think through. And the different bookends would be, okay, maybe we could get a really lethal sub-variant. Then that issue of us having a resistance profile that we're very confident about could be really important.

    當你考慮未來時,我想有不同的書擋可以讓人思考。不同的書擋是,好吧,也許我們可以得到一個真正致命的子變體。那麼我們有一個我們非常有信心的阻力概況的問題可能真的很重要。

  • The other possibility of a bookend is that this becomes sort of more endemic. So it's everyone's getting it. It's not necessarily that lethal for healthy people. But in that situation, like in flu, it is the most vulnerable patients are the ones who need to get treated, and that most vulnerable population are often those people you have to worry about drug-drug interactions, renal and liver insufficiency. So in that context with just COVID-19, that's how we think about molnupiravir.

    書擋的另一種可能性是,這變得更加流行。所以每個人都得到它。對於健康的人來說,這不一定是致命的。但在這種情況下,就像流感一樣,最脆弱的患者是需要接受治療的人,而最脆弱的人群通常是那些你不得不擔心藥物相互作用、腎功能不全和肝功能不全的人。因此,在只有 COVID-19 的情況下,這就是我們對莫努匹韋的看法。

  • In relationship to your question about eventually does the [field] have to really think about combination, I do think. And I do think it's important that we have an arsenal of multiple mechanism of actions because in every viral disease that I know, the virus is pretty good at evading different mechanisms of action.

    關於您關於 [field] 最終是否必須真正考慮組合的問題,我確實認為。而且我確實認為擁有多種作用機制的武器庫很重要,因為在我所知道的每一種病毒性疾病中,病毒都非常擅長逃避不同的作用機制。

  • And I think we may have to think about this combination issue that you've talked about. And we have invested both internal resources and other mechanisms of action. And we're in conversations with other people with different mechanism of action.

    我認為我們可能不得不考慮你談到的這個組合問題。我們已經投入了內部資源和其他行動機制。我們正在與具有不同行動機制的其他人進行對話。

  • So the fundamental thing is, I think, we need to have a view, that we need to be prepared, that we're going to need multiple options, and molnupiravir is an important part of the arsenal that this -- the United States and globally will need to have.

    因此,我認為,最根本的是,我們需要有一個觀點,我們需要做好準備,我們將需要多種選擇,而莫努匹拉韋是美國和美國軍火庫的重要組成部分全球將需要有。

  • Caroline Litchfield - Executive VP & CFO

    Caroline Litchfield - Executive VP & CFO

  • And if I may, this is Caroline. We have guided to $5 billion to $6 billion of revenue this year. That's on the basis of approximately 10 million courses.

    如果可以的話,我是卡羅琳。我們今年的收入已達到 50 億至 60 億美元。這是基於大約 1000 萬門課程。

  • To Dean's point, our company remains focused on ensuring there is enough supply, depending on how things move forward. So we are still committed to the 10 million courses we did manufacture in 2021 and more than double that in 2022. So we will have in excess of 30 million courses to support how the pandemic and how the use of molnupiravir progresses.

    在迪恩看來,我們公司仍然專注於確保有足夠的供應,這取決於事情的進展情況。因此,我們仍然致力於在 2021 年生產 1000 萬門課程,並在 2022 年增加一倍以上。因此,我們將擁有超過 3000 萬門課程來支持大流行和莫努匹韋的使用進展。

  • Operator

    Operator

  • Your next question comes from the line of Chris Shibutani from Goldman Sachs.

    您的下一個問題來自高盛的 Chris Shibutani。

  • Chris Shibutani - Research Analyst

    Chris Shibutani - Research Analyst

  • On KEYTRUDA, important parts of that leadership strategy is the adjuvant opportunity as both combinations. With the adjuvant, can you just comment a little bit more in terms of what you think you're seeing so far and how that's progressing?

    在 KEYTRUDA 上,領導戰略的重要部分是作為兩種組合的輔助機會。對於佐劑,您能否就您認為到目前為止所看到的內容以及進展情況發表更多評論?

  • And with the combinations, it looks like the data is scheduled to read out more in the '24, '25 time frame. Dean, perhaps, is there an opportunity that we might potentially be able to get a look earlier than then on any of the combination efforts?

    通過這些組合,看起來數據計劃在 24 年和 25 年的時間範圍內讀出更多信息。迪恩,也許,我們有可能比那時更早地了解任何联合努力嗎?

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Right. So I just want to emphasize. There are 2 types of combinations that we have. We have an IO-IO combinations, and I think that's what you're referring to in relationship to KEYTRUDA, whether it's with our TIGIT, LAG-3, CTLA4 and that. And you're right, those readouts are event-driven and the [fact sheet], and that will be -- we'll see where it is, but I think your timing is a reasonable sort of timing in terms of Phase III readouts.

    正確的。所以我只想強調。我們有兩種類型的組合。我們有一個 IO-IO 組合,我認為這就是您所指的與 KEYTRUDA 的關係,無論是與我們的 TIGIT、LAG-3、CTLA4 還是其他組合。你是對的,這些讀數是事件驅動的和[情況說明書],這將是 - 我們會看到它在哪裡,但我認為你的時間安排是第三階段讀數的合理時間安排.

  • In relationship to other combinations, I want to draw your attention to the combination of KEYTRUDA with chemotherapy, with other ADCs that we've worked with other companies with. But I would also focus your attention also on the readouts of KEYTRUDA with Lenvima that continue to spool up, and KEYTRUDA with Lynparza. And the reason why I think that's important is we think about how to raise the immuno-oncology profile of KEYTRUDA with other IO agents.

    關於其他組合,我想提請您注意 KEYTRUDA 與化療的組合,以及我們與其他公司合作過的其他 ADC。但我也會將您的注意力集中在 KEYTRUDA 與 Lenvima 的讀數上,該讀數繼續上升,以及 KEYTRUDA 與 Lynparza 的讀數。我認為這很重要的原因是我們考慮如何提高 KEYTRUDA 與其他 IO 藥物的免疫腫瘤學特徵。

  • But also as we see Lynparza and LENVIMA, they are -- they give us readouts of how to think about DNA repair and with combination in second and third generation of different sort of compounds in that place. And also in relationship to Lenvima, where you're looking at blocking vascular endothelial growth factor, RTKs, it gives us a thought as to how to think of drugs such as WELIREG, which also plays in that sort of same sort of play.

    但正如我們看到的 Lynparza 和 LENVIMA 一樣,它們為我們提供了關於如何思考 DNA 修復以及在那個地方結合第二代和第三代不同類型化合物的讀數。還有與 Lenvima 的關係,您正在研究阻斷血管內皮生長因子 RTK,它讓我們思考如何看待 WELIREG 等藥物,它也參與了類似的遊戲。

  • And so we're very interested in seeing how WELIREG plays out in sporadic renal cell carcinoma. And then we will ask ourselves outside of renal cell carcinoma where else should it play where an anti-angiogenesis agent has been shown to be effective.

    因此,我們非常有興趣了解 WELIREG 如何在散發性腎細胞癌中發揮作用。然後我們會問自己,在腎細胞癌之外,抗血管生成劑已被證明有效的其他地方應該發揮作用。

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Yes. And maybe, Chris, just to answer the first part of your question how are we seeing the adjuvant space, obviously, we are very excited about moving into earlier lines of therapy. We think this is a real area of growth.

    是的。也許,克里斯,只是為了回答你問題的第一部分,我們如何看待輔助空間,顯然,我們對進入早期治療線感到非常興奮。我們認為這是一個真正的增長領域。

  • Obviously, the strength we're seeing in KEYTRUDA is about how we're able to expand into new indications and continue to broaden. If you look, we had just in 2021 alone 21 approvals of new or expanded indications for KEYTRUDA. Three of those were in the adjuvant space, with adjuvant triple-negative breast cancer, adjuvant renal cell carcinoma and moving into a Stage II cancer in adjuvant melanoma.

    顯然,我們在 KEYTRUDA 中看到的優勢在於我們如何能夠擴展到新的適應症並繼續擴大。如果你看一下,僅在 2021 年,我們就獲得了 21 項 KEYTRUDA 新適應症或擴大適應症的批准。其中三個在輔助空間,輔助三陰性乳腺癌、輔助腎細胞癌和輔助黑色素瘤進入 II 期癌症。

  • So important growth there. And if you look at that, combined with the remaining other indications we already have and the other ones in adjuvant mel and what we hope to have soon with KEYNOTE-091 in adjuvant non-small cell lung cancer, we're looking at movement into the earlier spaces, driving approximately 50% of the growth for the drug for KEYTRUDA through 2025. And we think by 2025, it will be about 30% of our total revenue coming from the adjuvant indications we have.

    那裡的增長如此重要。如果你看一下,結合我們已經擁有的其余其他適應症和輔助 mel 的其他適應症,以及我們希望很快用 KEYNOTE-091 治療輔助非小細胞肺癌的其他適應症,我們正在研究進入早期的空間,到 2025 年推動 KEYTRUDA 藥物增長的約 50%。我們認為到 2025 年,我們總收入的 30% 左右來自我們擁有的輔助適應症。

  • So this is an area where we're starting to put runs on the Board. And I think we're going to show that the breadth of what KEYTRUDA could do, both in maintenance as well as in the metastatic space, is going to be very important as we build the leadership for the long term.

    所以這是我們開始在董事會上運行的一個領域。而且我認為我們將展示 KEYTRUDA 在維護和轉移領域所能做的廣度,這對於我們建立長期領導地位非常重要。

  • Peter Dannenbaum - VP of IR

    Peter Dannenbaum - VP of IR

  • And to be clear, Rob is referencing the U.S. markets.

    需要明確的是,Rob 指的是美國市場。

  • Operator

    Operator

  • Your next question comes from the line of Steve Scala from Cowen.

    您的下一個問題來自 Cowen 的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I'd like to ask about a more obscure pipeline agent. Sanofi believes that there is no discernible evidence of benefit of the Merck RSV monoclonal antibody versus the Sanofi monoclonal antibody, and that Sanofi is so far ahead that Sanofi unquestionably will dominate.

    我想問一個更不起眼的管道代理。賽諾菲認為,沒有明顯的證據表明默克 RSV 單克隆抗體與賽諾菲單克隆抗體相比具有優勢,賽諾菲遙遙領先,賽諾菲無疑將佔據主導地位。

  • So I'm wondering what Merck thinks. And if you disagree with Sanofi, then why is your antibody better than theirs?

    所以我想知道默克公司是怎麼想的。如果你不同意賽諾菲,那為什麼你的抗體比他們的好?

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Yes. I want to be a little bit careful that I'm answering questions about another company's drug. I think that having a monoclonal antibodies that can treat RSV in a really important patient population is critical.

    是的。在回答有關另一家公司的藥物的問題時,我想小心一點。我認為擁有可以在非常重要的患者群體中治療 RSV 的單克隆抗體至關重要。

  • We have data that will be coming out, and we'll have to see what that data looks like. But we do think that there is opportunity to have a really effective drug, that really is easier to provide to that patient population.

    我們有即將發布的數據,我們必須看看這些數據是什麼樣子的。但我們確實認為有機會獲得一種真正有效的藥物,這種藥物確實更容易提供給患者群體。

  • So I'm a little bit hesitant to comment directly, but we are very confident in the profile of our RSV antibody studies. And we will just have to see what the clinical data looks like as the clinical data comes through.

    所以我有點猶豫直接發表評論,但我們對我們的 RSV 抗體研究的概況非常有信心。當臨床數據通過時,我們只需要看看臨床數據是什麼樣子。

  • Operator

    Operator

  • Next, we have Umer Raffat from Evercore ISI.

    接下來是來自 Evercore ISI 的 Umer Raffat。

  • Jonathan Miller - VP

    Jonathan Miller - VP

  • This is Jon Miller on for Umer. On islatravir, is there -- obviously, the long duration and the long PK here is the major selling point. But is there any chance to avoid CD4 monitoring or maybe to get around some of the potential product issues that you've been looking at or evaluating?

    這是喬恩·米勒(Jon Miller)代表烏默(Umer)。關於islatravir,有沒有——顯然,這裡的長持續時間和長PK是主要賣點。但是有沒有機會避免 CD4 監控,或者繞過您一直在查看或評估的一些潛在產品問題?

  • If you stick to sub milligram daily dose rather than trying to push for the weekly or monthly doses, is that a potential path forward for islatravir in the HIV franchise?

    如果你堅持每日亞毫克劑量,而不是試圖推動每週或每月劑量,這是否是艾拉曲韋在 HIV 專營權中的潛在前進道路?

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Yes. So let me take that. So we are evaluating a considerable body of data. You mentioned trends of lymphocytes that have been observed in different trials that we've had.

    是的。所以讓我接受。因此,我們正在評估大量數據。您提到了在我們進行的不同試驗中觀察到的淋巴細胞趨勢。

  • I would point out that our Phase III with islatravir and doravirine demonstrated the efficacy and just the highly efficacious nature of islatravir in that combination, which is Q day. We will have a near-term evaluations of the future options, but we are still very committed to this longer acting sort of point of view as well.

    我要指出的是,我們與伊拉曲韋和多拉韋林的第三階段證明了伊拉曲韋在該組合中的功效和高度有效的性質,即 Q day。我們將對未來的選擇進行近期評估,但我們仍然非常致力於這種長期行動的觀點。

  • So to get to your question, we have data in relationship to Q day islatravir, doravirine, and it's highly efficacious. We are going to look at the body of data in relationship to other ways to continue to make that long sort of resident time, be able to have a less frequent either PrEP or treatment. And we're evaluating that data as we speak.

    所以為了回答你的問題,我們有與 Q day islatravir、doravirine 相關的數據,它非常有效。我們將研究與其他方式相關的數據體,以繼續延長住院時間,減少 PrEP 或治療的頻率。我們正在評估這些數據。

  • Operator

    Operator

  • Our next question comes from the line of Mara Goldstein from Mizuho.

    我們的下一個問題來自瑞穗的 Mara Goldstein。

  • Mara Goldstein - MD of Equity Research Department

    Mara Goldstein - MD of Equity Research Department

  • I'm wondering, in the last couple of weeks, there have been a number of comments made by some of your competitors around valuations in M&A. And since you did discuss acquisition as a part of strategy, I'm wondering if you could maybe opine as well as to where you think valuations are relative to the overall strategy of continuing to supplement the company's pipeline.

    我想知道,在過去的幾周里,你們的一些競爭對手就併購估值發表了許多評論。而且由於您確實將收購作為戰略的一部分進行了討論,我想知道您是否可以發表意見,以及您認為估值與繼續補充公司管道的總體戰略的關係。

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Yes. Thanks for the question, Mara. So as you pointed out, we are seeing in the biotech space valuations have pulled back quite a bit of late. I think it's too early to see whether or not this is a permanent rebasing in the market or if it is just a temporary change in the marketplace. We need to see how that plays out.

    是的。謝謝你的問題,瑪拉。正如您所指出的,我們看到生物技術領域的估值已經回落了很多。我認為現在判斷這是否是市場的永久性重新定位還是只是市場的暫時變化還為時過早。我們需要看看結果如何。

  • And the other thing, this could be important is what happens with the investment flows into the space. You are seeing IPOs start to slow. And it would be interesting to see if cash investments start to also slow down as people look to invest into the space with a lower valuation in the market, as you point out.

    另一件事,可能很重要的是投資流入該領域時會發生什麼。你看到 IPO 開始放緩。正如您所指出的,隨著人們希望投資於市場估值較低的領域,現金投資是否也開始放緩,這將是一件有趣的事情。

  • Whether or not that drives to sellers being willing to see the restatement of value that will allow us to do deals at different levels, we'll have to see. But it doesn't change the importance we see of doing business development for the company.

    這是否會促使賣家願意看到價值重述,這將使我們能夠在不同層次上進行交易,我們必須拭目以待。但這並沒有改變我們看到的為公司做業務發展的重要性。

  • And obviously, we're very focused, first and foremost, on driving and accelerating our own pipeline, but we know we have to augment it. And we are going to continue to focus in this area. And I'm confident that we're going to find the opportunities where the scientific opportunity match to our capabilities and where we see good value will allow us to do value-enhancing deals, regardless of the market situation.

    顯然,我們首先非常專注於推動和加速我們自己的管道,但我們知道我們必須加強它。我們將繼續專注於這一領域。而且我相信,無論市場情況如何,我們都會找到科學機會與我們的能力相匹配的機會,以及我們看到良好價值的機會,這將使我們能夠進行增值交易。

  • Operator

    Operator

  • Your next question comes from the line of Tim Anderson from Wolfe Research.

    您的下一個問題來自 Wolfe Research 的 Tim Anderson。

  • Unidentified Analyst

    Unidentified Analyst

  • This is [Adam] on behalf of Tim Anderson. On your oral PCSK9 program, you say that you're going into Phase II in 2022. Assuming that this takes 2 years to wrap up, what would a Phase III trial look like in terms of lengths and comparator? Guessing that this might not take until the late 2020s to report out.

    這是代表蒂姆安德森的[亞當]。在您的口服 PCSK9 計劃中,您說您將在 2022 年進入第二階段。假設這需要 2 年才能結束,就長度和比較器而言,第三階段試驗會是什麼樣子?猜測這可能要到 2020 年代後期才能報告出來。

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Yes. Thank you for that question. So the question is about our oral PCSK9 drug. We presented the Phase I sort of readouts in relationship to that. The Phase II readouts will be very important.

    是的。謝謝你的問題。所以問題是關於我們的口服 PCSK9 藥物。我們介紹了與此相關的第一階段讀數。第二階段的讀數將非常重要。

  • As everyone recognizes, cardiovascular risk is just a tremendous risk throughout. It's actually -- you could view it as an epidemic that continues, and there will be two sort of important considerations to take.

    眾所周知,心血管風險始終是一個巨大的風險。實際上,您可以將其視為一種持續流行的流行病,並且需要考慮兩種重要的考慮因素。

  • One is, as we advance the oral PCSK9, the biomarker of reducing LDL is a powerful biomarker that has been established as an important biomarker that has provided a path for registration based on that, even prior to having sort of readouts in terms of cardiovascular outcomes, in terms of death and heart patient endpoint.

    一個是,隨著我們推進口服 PCSK9,降低 LDL 的生物標誌物是一種強大的生物標誌物,它已被確立為一種重要的生物標誌物,它提供了基於此的註冊途徑,甚至在獲得心血管結果方面的某種讀數之前,就死亡和心髒病患者終點而言。

  • So we believe that we're going to have to do both, but we're very eager to see how well this agent works in our Phase II trials in driving the levels of LDL down, and that will give us the confidence to really advance this for patients. But again, driving the LDL down will be an important registrational point that has been a path for other drugs as well. But we will also have to do outcome study in addition to that.

    所以我們相信我們將不得不同時做這兩件事,但我們非常渴望看到這種藥物在我們的 II 期試驗中在降低 LDL 水平方面的效果如何,這將使我們有信心真正推進這對於患者來說。但同樣,降低 LDL 將是一個重要的註冊點,也是其他藥物的一條途徑。但除此之外,我們還必須進行結果研究。

  • Operator

    Operator

  • Next up, we have Matt Harrison from [Eres].

    接下來,我們有來自 [Eres] 的 Matt Harrison。

  • Unidentified Analyst

    Unidentified Analyst

  • This is Charlie Young for Matthew. Can you provide, in terms of your launch expectation of VAXNEUVANCE this year and perhaps even next year, especially after the pediatric indication approval?

    這是馬修的查理楊。您能否提供 VAXNEUVANCE 今年甚至明年的上市預期,尤其是在兒科適應症獲批後?

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Yes. So obviously, we're very excited about what VAXNEUVANCE and the opportunity to just present starting with, as you point out, the adult indication, which we received. And as you probably know, we did do the [NMWR] come out and validate the ACIP recommendation. So we're at a point now where reimbursement is established in the marketplace, and we are beginning to ship product.

    是的。很明顯,我們對 VAXNEUVANCE 的內容以及從我們收到的成人指示開始展示的機會感到非常興奮。您可能知道,我們確實 [NMWR] 出來並驗證了 ACIP 建議。因此,我們現在處於市場上建立報銷的階段,並且我們開始發貨。

  • As we look at this, we see a real opportunity because if we look at what is the profile of VAXNEUVANCE in combination with PNEUMOVAX 23, you're looking at an agent that has the broadest coverage. Between the 2, we have 15 serotypes in VAXNEUVANCE. We're adding 9 additional serotypes, 4 which are unique to PNEUMOVAX 23.

    當我們看到這個時,我們看到了一個真正的機會,因為如果我們結合 PNEUMOVAX 23 來看看 VAXNEUVANCE 的概況,你正在尋找一種覆蓋範圍最廣的代理。在這兩者之間,我們在 VAXNEUVANCE 中有 15 种血清型。我們正在添加 9 種額外的血清型,其中 4 種是 PNEUMOVAX 23 獨有的。

  • And as we look at the coverage, obviously, in things like serotype 3, we showed with VAXNEUVANCE that we are very competitive, if not superior to the competition in the marketplace. And we know that serotype 3 is an important contributor and driver of disease, as is serotypes 22F and 33F, which are in ours as well.

    當我們查看覆蓋範圍時,顯然,在血清型 3 等方面,我們向 VAXNEUVANCE 展示了我們非常有競爭力,如果不優於市場競爭的話。我們知道血清型 3 是疾病的重要貢獻者和驅動因素,血清型 22F 和 33F 也是如此,我們的血清型也是如此。

  • So as we look at it, you've got very broad coverage, you've got important coverage in high disease-causing serotypes. And we have important data showing how the drug works in at-risk and immunocompromised patients, which will be in the label -- is in the label.

    所以當我們看到它時,你有非常廣泛的覆蓋範圍,你在高致病血清型方面有重要的覆蓋範圍。我們有重要數據顯示藥物如何在高危和免疫功能低下的患者中發揮作用,這些數據將在標籤中 - 在標籤中。

  • So we're well positioned. We're going to have to obviously fight it out at the commercial level, but we think we're well positioned to do that. And we already are starting to look forward to what we see in the pediatric space.

    所以我們的定位很好。顯然,我們將不得不在商業層面上與之抗爭,但我們認為我們有能力做到這一點。我們已經開始期待我們在兒科領域看到的東西。

  • Right now, hopefully, we're going to see -- with the PDUFA in April, we're going to see hopefully the opportunity to get that drug into the marketplace. But obviously, we're going to build on the momentum from the launch in adults to then carry that forward into the pediatric setting. So far, all have started well, good contracting underway, and we're off to a good start. Thanks.

    現在,希望我們會看到——在 4 月份的 PDUFA 中,我們有望看到將這種藥物推向市場的機會。但很明顯,我們將利用在成人中推出的勢頭,然後將其推進到兒科環境中。到目前為止,一切都開始良好,良好的合同正在進行中,我們有了一個良好的開端。謝謝。

  • Operator

    Operator

  • We have Andrew Baum from Citi.

    我們有來自花旗的 Andrew Baum。

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • A question on islatravir. Are you in a position to disprove mitochondrial toxicity as a cause for the lymphocyte compression? Or would you file for approval for the once-a-day combination if you have no clear line of sight on a longer dosing period formulations?

    關於伊拉曲韋的問題。您是否能夠反駁線粒體毒性是導致淋巴細胞受壓的原因?或者,如果您對較長給藥期的配方沒有明確的看法,您是否會申請批准每天一次的組合?

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • You broke up just a little bit. In relationship to the mechanism by which the lymphocyte trends that we've disclosed is going down. We're looking at the mechanism of action.

    你分手了一點點。與我們披露的淋巴細胞趨勢下降的機制有關。我們正在研究作用機制。

  • I would say just two brief points. One is there's a question of whether or not there are ways to get around it by looking at the dose that was provided. And then the second sort of question is the mechanism. The mechanism, we're still evaluating.

    我只想說兩點。一個問題是,是否有辦法通過查看提供的劑量來繞過它。第二類問題是機制。機制,我們仍在評估中。

  • I believe your question was in relationships with mitochondrial toxicity. That does not list as the first place that we would go in relationship to the data that we have right now. But I don't want to rule out anything right now as we're evaluating all the data as we speak.

    我相信你的問題與線粒體毒性有關。這並沒有將我們列為與我們現在擁有的數據相關的第一個位置。但我現在不想排除任何事情,因為我們正在評估所有數據。

  • Operator

    Operator

  • Next, we have Louise Chen from Cantor.

    接下來,我們有來自 Cantor 的 Louise Chen。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So I want to ask you if the headlines about the logistical obstacles for oral antivirals, how accurate are they? And if they are, how are you working through them?

    所以我想問你,關於口服抗病毒藥物後勤障礙的頭條新聞,它們的準確性如何?如果他們是,你是如何通過他們工作的?

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Yes. I appreciate the question, Louise. So if you look at the situation, and I think you're probably focused mainly in the United States, we are in a situation where we did deliver to the United States doses of courses of therapy before the end of the year, a little over 900,000 courses of therapy were delivered to them.

    是的。我很欣賞這個問題,路易絲。所以如果你看一下情況,我認為你可能主要關注美國,我們的情況是,我們確實在今年年底之前向美國提供了一些療程的治療,稍微多一點為他們提供了 900,000 個療程。

  • Since then, we continue to add to that. And by the end of this week, we should be to the full 3.1 million courses delivered to the distribution hubs that they have.

    從那時起,我們繼續添加。到本週末,我們應該可以將全部 310 萬門課程交付到他們擁有的分發中心。

  • Obviously, at that point, it's us working with the government, but it's up to the government on where and how they distribute it from the hubs out into the pharmacies and the local markets.

    顯然,在這一點上,是我們與政府合作,但取決於政府將其從中心分配到藥店和當地市場的地點和方式。

  • I think the real thing we're focusing on in discussions with the government is how do we increase the messaging to help people understand how they can find out, where they can go to get to antivirals. And there's locator sites that the government has on the web. And we're trying to make sure as much as we can to help people know to go look there because the drug is in the marketplace, you just have to be able to find out where to go find it. And we will continue to partner with the government any way they need to ensure we can get access as quickly and as broadly as possible.

    我認為我們在與政府的討論中真正關注的是我們如何增加信息傳遞,以幫助人們了解他們如何找到答案,他們可以去哪裡獲得抗病毒藥物。還有政府在網上的定位器網站。我們正在努力確保盡可能多地幫助人們知道去那裡尋找,因為這種藥物在市場上,你只需要能夠找到去哪裡找到它。我們將繼續以他們需要的任何方式與政府合作,以確保我們能夠盡快和盡可能廣泛地獲得訪問權限。

  • Obviously, we're very focused beyond the U.S. as well, and I feel very good about what we're doing. You probably saw we announced that we had a deal with UNICEF for 3 million courses. That really is us trying to help make sure we could accelerate access to the low- and middle-income countries as we wait for the generic manufacturers.

    顯然,我們也非常關注美國以外的地區,我對我們正在做的事情感覺非常好。您可能看到我們宣布與聯合國兒童基金會就 300 萬門課程達成協議。這確實是我們在等待仿製藥製造商時試圖幫助確保我們能夠加快進入低收入和中等收入國家的速度。

  • So we had the licenses with as they ramp up production. So hopefully, that will help fill in the gap in those markets as we wait for the generics to be able to ultimately come online.

    因此,隨著他們提高產量,我們獲得了許可證。所以希望這將有助於填補這些市場的空白,因為我們等待仿製藥最終能夠上線。

  • Operator

    Operator

  • Next, we have Daina Graybosch from SVB Leerink.

    接下來,我們有來自 SVB Leerink 的 Daina Graybosch。

  • Daina Michelle Graybosch - MD of Immuno-Oncology & Senior Research Analyst

    Daina Michelle Graybosch - MD of Immuno-Oncology & Senior Research Analyst

  • I'm going to go back to KEYTRUDA in oncology and the IO combination. So we're going to see this year, I think, multiple randomized readouts of TIGIT from Roche. And I think, as somebody mentioned earlier, you guys have multiple trials of TIGIT and LAG-3 coming in the future.

    我將回到 KEYTRUDA 的腫瘤學和 IO 組合。因此,我認為今年我們將看到羅氏公司對 TIGIT 的多個隨機讀數。而且我認為,正如前面有人提到的,你們將來會有 TIGIT 和 LAG-3 的多次試驗。

  • I wonder if you could talk to how your development strategy could be differentiating for these IO-IO combinations. In particular, can you highlight anywhere where your base position of KEYTRUDA may give you an advantage?

    我想知道您是否可以談談您的開發策略如何區分這些 IO-IO 組合。特別是,您能否突出顯示您在 KEYTRUDA 的基本位置可能會給您帶來優勢的任何地方?

  • Dean Y. Li - Executive VP & President of Merck Research Laboratories

    Dean Y. Li - Executive VP & President of Merck Research Laboratories

  • Let me take the scientific question in relationship to that. So thanks for that question. I would emphasize just the general principle that we have, which is we believe that there are ways to improve the immuno-oncology sort of access of PD-1 by adding another checkpoint inhibitor.

    讓我來談談與此相關的科學問題。所以感謝這個問題。我只想強調我們擁有的一般原則,即我們相信有辦法通過添加另一種檢查點抑製劑來改善 PD-1 的免疫腫瘤學類型。

  • We believe that, that is going to be potentially a different checkpoint inhibitor or a different addition to PD-1 given a different tumor cut. So we're not so sure that there is one additional checkpoint inhibitor that you could add to PD-1 that would have as broad of a impact as P1 has itself.

    我們相信,考慮到不同的腫瘤切口,這可能是一種不同的檢查點抑製劑或對 PD-1 的不同添加。所以我們不太確定是否有一種額外的檢查點抑製劑可以添加到 PD-1 中,它會產生與 P1 本身一樣廣泛的影響。

  • So our strategy has been to invest in CTLA-4, to invest in TIGIT, to invest in LAG-3, to invest in ILT4. I think the strategy of some of our other colleagues is to place a larger bet on each of those combinations more broadly. So I think that's something that I think is really important.

    所以我們的策略是投資CTLA-4,投資TIGIT,投資LAG-3,投資ILT4。我認為我們其他一些同事的策略是在更廣泛的每個組合上下更大的賭注。所以我認為這是我認為非常重要的事情。

  • The second point that I would also emphasize is you want to show contribution of components, and you want to show that what you're added on to the PD-1 is really better than the PD-1. And the reason I want to emphasize that is that one should also look at what the base of our PD-1 response is compared to others in relationships. So it is my belief that targeting the PD-1 axis is, in general, more effective than, for example, a PD-L1. So that gives us a distinguishing position as well.

    我還要強調的第二點是你想展示組件的貢獻,並且你想展示你添加到 PD-1 上的東西確實比 PD-1 更好。我想強調這一點的原因是,人們還應該看看我們的 PD-1 反應的基礎與其他關係的比較。因此,我認為靶向 PD-1 軸通常比例如 PD-L1 更有效。所以這也給了我們一個獨特的位置。

  • And then the third issue is, especially in lung, where physicians are very comfortable in relationship of where we stand in relationship with PD-1, with our PD-L1 monotherapy sort of differentiation as well as PD-1 plus chemo in relationship. And also we're driving our PD-1 into earlier stages of cancer, for example, in lung and others. I think that gives us sort of a leg-up as well.

    然後第三個問題是,特別是在肺部,醫生對我們與 PD-1 的關係、我們的 PD-L1 單一療法類型的分化以及 PD-1 加化療的關係非常滿意。而且我們正在推動我們的 PD-1 進入癌症的早期階段,例如,在肺癌和其他癌症中。我認為這也給了我們一些幫助。

  • So three things. One is how we think strategically about IO-IO combinations. And then the second sort of thing is in relationship to PD-1 versus a non-PD-1 sort of position, so PD-1 versus a PD-L1. And also our ability to sort of paint the whole from adjuvant all the way to later stage is something that I think gives physicians enormous comfort in our base drug.

    所以三件事。一是我們如何從戰略上思考 IO-IO 組合。然後第二類事情與 PD-1 與非 PD-1 的位置有關,所以 PD-1 與 PD-L1 的關係。而且,我們從輔助藥物一直到後期的整體繪製能力,我認為這讓醫生對我們的基礎藥物感到非常舒適。

  • Peter Dannenbaum - VP of IR

    Peter Dannenbaum - VP of IR

  • Great. Thank you, Dean. Thank you, Daina. And thank you all for your good questions today. We realize there is a peer call starting right now, so we want to be mindful of that. If you have any follow-ups, please reach out to the IR team at any time, but we appreciate the good questions today and your interest. Thank you.

    偉大的。謝謝你,院長。謝謝你,戴娜。感謝大家今天提出的好問題。我們意識到現在開始有一個同行電話會議,所以我們要注意這一點。如果您有任何後續行動,請隨時與 IR 團隊聯繫,但我們感謝您今天提出的好問題和您的興趣。謝謝你。

  • Robert M. Davis - President, CEO & Director

    Robert M. Davis - President, CEO & Director

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now all disconnect.

    女士們,先生們,今天的電話會議到此結束。謝謝大家的加入。您現在可以全部斷開連接。