Rob 在擔任默克 CEO 的短短時間裡取得了巨大的成就,他明確表示他致力於通過多種方式改善公司。他希望建立公司的管道,改善癌症治療的可及性,並增加科學創新。 RAS 計劃是他如何努力改善公司的一個例子。 2019 年第一季度,默克公司報告稱,該公司的急症護理產品組合強勁增長。受市場份額增加和外科手術增加的推動,神經肌肉阻滯逆轉劑 BRIDION 的銷售額在第一季度增長了 22%。受家禽產品和反芻動物技術解決方案銷售額增長的推動,第一季度動物保健品銷售額增長了 4%。伴侶動物銷售增長由 BRAVECTO 系列產品推動,部分被某些疫苗的供應挑戰所抵消。
第一季度毛利率為 77%,增長 0.2 個百分點,反映了有利的產品組合和外匯,部分被利潤率下降的 LAGEVRIO 和供應銷售的影響所抵消。第一季度的運營費用為 60 億美元,其中包括與某些合作和許可協議相關的 6.19 億美元。剔除這些款項,第一季度的運營費用增長了 13%,這是由於增加了投資以支持公司的主要增長動力和管道。
第一季度的其他支出約為 1 億美元,這反映了與去年同期相比較低的養老金支出。該公司第一季度的稅率為13.6%。默克公司第一季度每股收益 1.85 美元,其中包括與重大合作和許可協議相關的 0.22 美元費用。不計這些費用,該公司的基本增長為每股 1.63 美元。
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
Ladies and gentlemen, thank you for standing by. Good morning. My name is Lia West, and I will be your conference moderator today. At this time, I would like to welcome everyone to the Merck & Co. Q3 Sales and Earnings Conference Call. (Operator Instructions)
女士們,先生們,謝謝你們的支持。早上好。我叫 Lia West,今天我將擔任您的會議主持人。在這個時候,我想歡迎大家參加默克公司第三季度銷售和收益電話會議。 (操作員說明)
As a reminder, this conference is being recorded. I would now like to turn the conference over to Peter Dannenbaum, Vice President of Investor Relations. Please go ahead.
提醒一下,本次會議正在錄製中。我現在想將會議轉交給投資者關係副總裁 Peter Dannenbaum。請繼續。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thank you, and good morning. Welcome to Merck's Third Quarter 2022 Conference Call. Speaking on today's call will be Rob Davis, President and Chief Executive Officer; Caroline Litchfield, Chief Financial Officer; and Dr. Dean Li, President of Merck Research Labs.
謝謝你,早上好。歡迎來到默克公司 2022 年第三季度電話會議。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 have 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.
我想提醒您,我們今天所做的一些陳述可能被視為 1995 年美國私人證券訴訟改革法案的安全港條款含義內的前瞻性陳述。這些陳述是基於當前的信念做出的默克的管理層,並受到重大風險和不確定性的影響。
If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2021 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements.
如果我們的基本假設被證明不准確或不確定性成為現實,實際結果可能與前瞻性陳述中所述的結果大不相同。我們向美國證券交易委員會提交的文件,包括 2021 年 10-K 中的第 1A 項,確定了可能導致公司的實際結果與我們今天上午做出的任何前瞻性陳述中預測的結果存在重大差異的某些風險因素和警示性陳述。默克不承擔公開更新任何前瞻性陳述的義務。
During today's call, a slide presentation will accompany our 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, and thank you for joining today's call. Our strong performance this quarter reflects sustained momentum across our key growth drivers and steady progress in our pipeline. We're well positioned to successfully close out the year, and we look forward to building on this momentum in 2023 and beyond.
謝謝,彼得。早上好,感謝您加入今天的電話會議。我們本季度的強勁表現反映了我們關鍵增長動力的持續勢頭和我們管道的穩步進展。我們已做好準備成功結束這一年,我們期待在 2023 年及以後繼續保持這一勢頭。
We're delivering across our strategic priorities and executing well scientifically, operationally and commercially. As a result, our pipeline is advancing, our business is healthy, our growth pillars are intact and our financial performance is strong. We remain keenly focused on sustaining the success by driving continued growth and delivering long-term value to patients and shareholders.
我們正在實現我們的戰略重點,並在科學、運營和商業上都執行得很好。因此,我們的管道正在推進,我們的業務健康,我們的增長支柱完好無損,我們的財務表現強勁。我們仍然專注於通過推動持續增長和為患者和股東提供長期價值來維持成功。
With that, let's turn first to our results. We're pleased to report exceptional revenue and underlying earnings growth again this quarter. We continue to see robust demand for our innovative human and animal health portfolios, including for products such as KEYTRUDA, GARDASIL, BRIDION and BRAVECTO. Our updated guidance reflects our expectation of truly standout full year growth.
有了這個,讓我們首先來看我們的結果。我們很高興在本季度再次報告出色的收入和基本收益增長。我們繼續看到對我們創新的人類和動物健康產品組合的強勁需求,包括對 KEYTRUDA、GARDASIL、BRIDION 和 BRAVECTO 等產品的需求。我們更新的指導反映了我們對真正出色的全年增長的期望。
Moving to our research organization. We made considerable progress across multiple therapeutic areas. In cardiovascular, the top line results of the STELLAR Phase III trial evaluating sotatercept in patients with pulmonary arterial hypertension achieved successful outcomes across both the primary and almost every secondary endpoint, suggesting the potential to transform the treatment of patients suffering from this devastating disease.
搬到我們的研究機構。我們在多個治療領域取得了長足的進步。在心血管方面,STELLAR III 期試驗的主要結果評估了肺動脈高壓患者的 sotatercept,在主要終點和幾乎所有次要終點均取得了成功,這表明有可能改變患有這種毀滅性疾病的患者的治療。
I'm proud of the way our research organization has moved swiftly following last year's acquisition of Acceleron to advance sotatercept's development. We continue to advance other programs across our broad cardiovascular pipeline, including our Factor XI inhibitor, which recently received an FDA Fast Track designation for patients with end-stage renal disease.
我為我們的研究機構在去年收購 Acceleron 以推進 sotatercept 的發展後迅速採取行動的方式感到自豪。我們繼續在我們廣泛的心血管管道中推進其他項目,包括我們的因子 XI 抑製劑,該抑製劑最近獲得了 FDA 對終末期腎病患者的快速通道指定。
Turning to oncology, we presented encouraging results at ESMO across our broad portfolio and promising pipeline. Long-term survival data reinforces the durable benefits of KEYTRUDA and Lynparza for certain patients. We remain enthusiastic about the potential of KEYTRUDA in earlier stages of cancer as well as in combination with other agents.
談到腫瘤學,我們在 ESMO 展示了我們廣泛的產品組合和有希望的管道的令人鼓舞的結果。長期生存數據強化了 KEYTRUDA 和 Lynparza 對某些患者的持久益處。我們仍然對 KEYTRUDA 在癌症早期階段以及與其他藥物聯合使用的潛力充滿熱情。
In vaccines, we launched VAXNEUVANCE in the pediatric setting and are progressing our Phase III trial of V116 in adults, an important component of our population-specific approach to invasive pneumococcal disease and part of our broader efforts to provide strong protection to both infants and adults. And finally, in HIV, we are pleased that there is a path forward for islatravir clinical trials in the treatment setting. We remain committed to helping address unmet needs in both treatment and prevention.
在疫苗方面,我們在兒科環境中推出了 VAXNEUVANCE,並正在推進我們在成人中的 V116 III 期試驗,這是我們針對侵襲性肺炎球菌疾病的人群特異性方法的重要組成部分,也是我們為嬰兒和成人提供強有力保護的更廣泛努力的一部分.最後,在 HIV 方面,我們很高興在治療環境中進行 islatravir 臨床試驗有一條前進的道路。我們仍然致力於幫助解決治療和預防方面未滿足的需求。
Moving to our efforts around sustainability. We continue to execute on our priorities, further demonstrating our long-standing commitment to delivering value to society which in turn creates value for shareholders. In August, we published our annual ESG progress report, which provides a comprehensive review of our sustainability strategy, initiatives underway and progress against our goals.
轉向我們圍繞可持續發展所做的努力。我們繼續執行我們的優先事項,進一步表明我們長期以來致力於為社會創造價值,進而為股東創造價值。 8 月,我們發布了年度 ESG 進展報告,全面回顧了我們的可持續發展戰略、正在進行的舉措以及實現目標的進展。
Consistent with our mission, we're focused on access to health, ensuring that our inventions reach as many patients as possible. To enable access, we're committed to responsibly discovering and manufacturing our medicines and vaccines, to bringing our best ideas forward through the empowerment of our talented and diverse employees and to always operating with strong ethics and values.
與我們的使命一致,我們專注於獲得健康,確保我們的發明惠及盡可能多的患者。為了實現訪問,我們致力於以負責任的方式發現和製造我們的藥物和疫苗,通過賦予我們才華橫溢和多元化的員工權力來提出我們最好的想法,並始終以強烈的道德和價值觀運作。
Some of our initiatives include a commitment to providing 91.5 million doses of HPV vaccines in GAVI-supported countries, advancing our goal to achieve carbon neutrality by 2025 and supporting projects and partnerships in our priority areas through the issuance of an inaugural $1 billion sustainability bond. Our approach to sustainability helps propel and enable our business strategy in ways that align with our operating priorities. This makes us a better company and global citizen, creating value for society and for shareholders.
我們的一些舉措包括承諾在 GAVI 支持的國家提供 9150 萬劑 HPV 疫苗,推進我們到 2025 年實現碳中和的目標,並通過發行首期 10 億美元的可持續發展債券來支持我們優先領域的項目和夥伴關係。我們的可持續發展方法有助於以符合我們運營重點的方式推動和實現我們的業務戰略。這使我們成為更好的公司和全球公民,為社會和股東創造價值。
Yesterday evening, we also announced that Ken Frazier will be retiring from his role as Chairman of Merck's Board of Directors at the end of November. I know I speak on behalf of the entire company and our Board in expressing our deepest appreciation for Ken, his principal leadership, respect for science, passion for engaging with employees everywhere, commitment to patients and health equity and contributions to communities around the world. Speaking personally, I'm deeply grateful for the inspiration, mentorship and support Ken has provided to me.
昨天晚上,我們還宣布 Ken Frazier 將於 11 月底卸任默克公司董事會主席一職。我知道我代表整個公司和我們的董事會對 Ken 表示最深切的感謝,感謝他的主要領導能力、對科學的尊重、對與各地員工互動的熱情、對患者和健康公平的承諾以及對世界各地社區的貢獻。就我個人而言,我非常感謝 Ken 為我提供的靈感、指導和支持。
Moving ahead, I look forward to working with the Board in my new role as Chairman as we continue to build on Ken's legacy and drive core to our purpose of using leading-edge science to save and improve lives globally. I'm confident that we have the fundamental building blocks in place to achieve sustainable growth and value creation. This is exemplified by our talented team of scientists and our colleagues all around the world who are dedicated to discovering, developing and delivering life-changing medicines and vaccines. I'm very confident in the short- and long-term outlook of our company, and I look forward to continuing to share progress as we move into the future.
展望未來,我期待著在擔任董事長的新職務上與董事會合作,我們將繼續發揚 Ken 的遺產,並推動核心實現我們利用前沿科學拯救和改善全球生活的目標。我相信我們擁有實現可持續增長和價值創造的基本組成部分。這體現在我們才華橫溢的科學家團隊和我們在世界各地的同事,他們致力於發現、開發和提供改變生活的藥物和疫苗。我對我們公司的短期和長期前景充滿信心,並期待在我們邁向未來的過程中繼續分享進步。
With that, I'll turn the call over to Caroline.
有了這個,我會把電話轉給卡羅琳。
Caroline Litchfield - Executive VP & CFO
Caroline Litchfield - Executive VP & CFO
Thank you, Rob. Good morning. 2022 continues to be a year of excellent performance for our business. This quarter, we again achieved exceptional revenue and underlying earnings growth, driven by demand for our innovative portfolio. These results reinforce our commitment to our science-led strategy, enabled by the flawless execution of our dedicated colleagues across the globe. We are confident in our ability to continue to deliver in the short term while we make disciplined investments to maximize long-term value for patients and shareholders.
謝謝你,羅布。早上好。 2022 年仍然是我們業務表現出色的一年。本季度,在對我們創新產品組合的需求的推動下,我們再次實現了卓越的收入和基本盈利增長。這些結果強化了我們對以科學為主導的戰略的承諾,這得益於我們在全球範圍內敬業的同事的完美執行。我們對我們在短期內繼續交付的能力充滿信心,同時我們進行有紀律的投資,以最大限度地為患者和股東帶來長期價值。
Total company revenues were $15 billion, an increase of 14%. Excluding LAGEVRIO, the business delivered strong growth of 10%. Underlying growth was 4 percentage points higher, given the growing headwind from foreign exchange.
公司總收入為 150 億美元,增長 14%。不包括 LAGEVRIO,該業務實現了 10% 的強勁增長。鑑於來自外彙的逆風越來越大,基本增長率提高了 4 個百分點。
The remainder of my revenue comments will be on an ex exchange basis. Our human health business continued its momentum with growth of 19%, or 15% excluding LAGEVRIO, driven by strength across our key pillars. Our Animal Health business delivered a solid quarter as sales increased 4% in both our companion animal and livestock products.
我的其餘收入評論將以交換為基礎。我們的人類健康業務繼續保持增長勢頭,增長 19%,不包括 LAGEVRIO,增長 15%,這得益於我們關鍵支柱的實力。我們的動物保健業務實現了穩健的季度,我們的伴侶動物和牲畜產品的銷售額均增長了 4%。
Now turning to the third quarter performance of our key brands. In oncology, KEYTRUDA grew 26% to $5.4 billion, driven by strong global demand as well as continued expansion into new indications. In the U.S., KEYTRUDA grew across all key tumor types and continued to benefit from uptake in earlier-stage cancers, including triple-negative breast cancer as well as in certain types of renal cell carcinoma and melanoma.
現在轉向我們主要品牌的第三季度業績。在腫瘤學領域, KEYTRUDA 增長 26% 至 54 億美元,這得益於強勁的全球需求以及新適應症的持續擴張。在美國, KEYTRUDA 在所有關鍵腫瘤類型中均增長,並繼續受益於早期癌症的吸收,包括三陰性乳腺癌以及某些類型的腎細胞癌和黑色素瘤。
Intervening earlier in cancer progression provides the potential for better patient outcomes, which is why we remain excited by the impact KEYTRUDA is having on patients with these early-stage cancers. Notably, there continues to be very strong demand in neoadjuvant, adjuvant, high-risk, early-stage triple-negative breast cancer, a testament to the profound effect KEYTRUDA is having for patients with this aggressive form of disease. In the metastatic setting, KEYTRUDA is maintaining its leadership position in non-small cell lung cancer.
早期干預癌症進展提供了改善患者預後的潛力,這就是為什麼我們對 KEYTRUDA 對這些早期癌症患者的影響感到興奮。值得注意的是,對新輔助、輔助、高風險、早期三陰性乳腺癌的需求仍然非常強勁,這證明了 KEYTRUDA 對患有這種侵襲性疾病的患者產生的深遠影響。在轉移性環境中, KEYTRUDA 保持其在非小細胞肺癌領域的領先地位。
Outside the U.S., KEYTRUDA growth continues to be driven by uptake in non-small cell lung cancer, head and neck cancer and renal cell carcinoma. Recently approved earlier-stage indications, including certain types of high-risk, early-stage triple-negative breast cancer and renal cell carcinoma are off to a strong start following launches in key European markets earlier this year.
在美國以外, KEYTRUDA 的增長繼續受到非小細胞肺癌、頭頸癌和腎細胞癌的吸收推動。最近批准的早期適應症,包括某些類型的高風險、早期三陰性乳腺癌和腎細胞癌,在今年早些時候在歐洲主要市場推出後,開局強勁。
Lynparza maintained its leadership of the PARP inhibitor class. Our alliance revenue grew 23%, driven by continued demand in certain patients with high-risk, early-stage breast cancer based on the OlympiA study. The outlook for Lynparza remains strong. And if approved, we are confident in the potential to reach patients with metastatic castration-resistant prostate cancer based on the PROpel study.
Lynparza 保持其在 PARP 抑製劑類別的領導地位。根據 OlympiA 研究,由於某些高危早期乳腺癌患者的持續需求,我們的聯盟收入增長了 23%。 Lynparza 的前景依然強勁。如果獲得批准,我們對基於 PROpel 研究的轉移性去勢抵抗性前列腺癌患者的潛力充滿信心。
Lenvima alliance revenue grew 11%, a strong demand in the U.S. driven by continued uptake in advanced renal cell carcinoma and endometrial cancer, was partially offset by shipment timing in China. Lastly, WELIREG is performing consistent with our expectations, providing a treatment option to the significant unmet need of patients with certain VHL-associated tumors.
Lenvima 聯盟的收入增長了 11%,由於晚期腎細胞癌和子宮內膜癌的持續增長,美國的強勁需求被中國的出貨時間部分抵消。最後,WELIREG 的表現符合我們的預期,為某些 VHL 相關腫瘤患者的重大未滿足需求提供了一種治療選擇。
Our vaccines portfolio achieved excellent growth led by GARDASIL, which increased 20% to $2.3 billion. Growth is being driven by strong underlying demand in ex-U.S. markets, particularly China. We recently received approval from China's National Medical Products Administration to expand the use of GARDASIL 9 to girls and women 9 to 45 years of age, which will further expand our opportunity in this important market. Growth in the U.S. was due to timing of CDC purchases, which will negatively impact fourth quarter sales.
我們的疫苗組合在 GARDASIL 的帶領下實現了出色的增長,增長了 20%,達到 23 億美元。美國以外地區強勁的潛在需求推動了增長市場,尤其是中國。我們最近獲得了中國國家藥品監督管理局的批准,將 GARDASIL 9 的使用範圍擴大到 9 至 45 歲的女孩和女性,這將進一步擴大我們在這個重要市場的機會。美國的增長是由於 CDC 採購的時機,這將對第四季度的銷售產生負面影響。
We are confident in our ability to drive sustainable growth of GARDASIL given its proven effectiveness in preventing certain types of HPV-related cancers and other diseases. Global immunization levels remain low, which provides us a tremendous opportunity to benefit more patients. And we have invested aggressively in manufacturing capacity, which positions us well to supply the demand we expect to see now and over the long term.
鑑於 GARDASIL 在預防某些類型的 HPV 相關癌症和其他疾病方面已證明有效,我們對推動 GARDASIL 可持續增長的能力充滿信心。全球免疫水平仍然很低,這為我們提供了造福更多患者的巨大機會。我們在製造能力方面進行了積極投資,這使我們能夠很好地滿足我們現在和長期預期的需求。
In our hospital acute care portfolio, BRIDION sales grew 22%, driven by an increase in market share among neuromuscular blockade reversal agents and an increase in surgical procedures. As mentioned earlier, Animal Health sales increased 4%. Livestock sales increased due to poultry products and ruminant technology solutions. Companion animal sales growth was driven by the BRAVECTO line of products, partially offset by supply challenges for certain vaccines.
在我們的醫院急症護理產品組合中,BRIDION 銷售額增長了 22%,這得益於神經肌肉阻滯逆轉劑市場份額的增加和外科手術的增加。如前所述,動物保健品的銷售額增長了 4%。由於家禽產品和反芻動物技術解決方案,畜牧業銷售額增加。伴侶動物銷售增長由 BRAVECTO 系列產品推動,部分被某些疫苗的供應挑戰所抵消。
I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin was 77%, an increase of 0.2 percentage points, reflecting favorable product mix and foreign exchange, partially offset by the impact of lower margin LAGEVRIO and supply sales. Operating expenses were $6 billion, which includes $619 million of payments related to certain collaborations and licensing agreements. Excluding these payments, operating expenses grew 13%, driven by increased investments to support our key growth drivers and pipeline.
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 77%,增長 0.2 個百分點,反映有利的產品組合和外匯,部分被較低利潤率的 LAGEVRIO 和供應銷售的影響所抵消。運營費用為 60 億美元,其中包括與某些合作和許可協議相關的 6.19 億美元。不包括這些付款,運營費用增長了 13%,這是由於增加投資以支持我們的主要增長動力和管道。
Other expense was approximately $100 million, which reflects lower pension expense compared to last year. Our tax rate was 13.6%. Taken together, we earned $1.85 per share, which includes $0.22 of charges related to significant collaborations and licensing agreement. Excluding these charges, we had exceptional underlying growth.
其他支出約為 1 億美元,這反映了與去年相比較低的養老金支出。我們的稅率是 13.6%。總之,我們每股收益 1.85 美元,其中包括與重大合作和許可協議相關的 0.22 美元費用。不計這些費用,我們的潛在增長非常出色。
Turning now to our 2022 non-GAAP guidance. The continued operational strength of our business enables us to raise and narrow our full year revenue guidance. We now expect revenue to be between $58.5 billion and $59 billion, including LAGEVRIO sales of $5.2 billion to $5.4 billion. Our increased revenue guidance range represents growth of 20% to 21%.
現在轉向我們的 2022 年非 GAAP 指導。我們業務的持續運營實力使我們能夠提高和縮小全年收入指導。我們現在預計收入將在 585 億美元至 590 億美元之間,其中 LAGEVRIO 的銷售額為 52 億美元至 54 億美元。我們增加的收入指導範圍代表增長 20% 至 21%。
The projected impact from foreign exchange includes an incremental headwind of nearly 1% using mid-October rates, resulting in a full year negative impact of approximately 4%. Excluding foreign exchange and LAGEVRIO, we expect growth of approximately 16%.
外彙的預計影響包括使用 10 月中旬的匯率增加近 1% 的逆風,導致全年約 4% 的負面影響。不包括外彙和 LAGEVRIO,我們預計增長約 16%。
We are maintaining our gross margin expectation of between 74% and 74.5%. We are increasing and narrowing our operating expense projection to $21.3 billion to $21.7 billion, principally driven by a $250 million payment related to the recent exercise of our option to jointly develop a personalized cancer vaccine as part of our ongoing collaboration with Moderna.
我們將毛利率預期維持在 74% 至 74.5% 之間。我們正在將我們的運營費用預測增加並縮小至 213 億美元至 217 億美元,這主要是由於我們最近行使與 Moderna 合作開發個性化癌症疫苗的選擇權相關的 2.5 億美元付款。
As a reminder, our guidance does not assume additional significant potential business development transactions. We continue to assume other expense of approximately $500 million. We expect our full year tax rate to be approximately 14%. We assume 2.54 billion shares outstanding. Taken together, we have increased and narrowed our expected EPS rate to $7.32 to $7.37, an increase of $0.05 at the midpoint.
提醒一下,我們的指導不假設額外的重大潛在業務發展交易。我們繼續承擔大約 5 億美元的其他費用。我們預計全年稅率約為 14%。我們假設有 25.4 億股流通股。綜上所述,我們將預期每股收益提高並縮小至 7.32 美元至 7.37 美元,中點增加了 0.05 美元。
The operational momentum in our business would have led to an approximately $0.20 increase in our guidance. However, this is being partially offset by the option payments in Moderna and an incremental headwind from foreign exchange of nearly 1% using mid-October rates.
我們業務的運營勢頭將導致我們的指導增加約 0.20 美元。然而,這部分被 Moderna 的期權支付和使用 10 月中旬匯率帶來的近 1% 的外匯逆風所抵消。
Our guidance reflects confidence in the underlying strength of our business. We continue to demonstrate strong momentum and expect durable underlying demand across our key pillars, including KEYTRUDA, GARDASIL and Animal Health.
我們的指導反映了對我們業務潛在實力的信心。我們繼續表現出強勁的勢頭,並預計我們的主要支柱(包括 KEYTRUDA、GARDASIL 和動物健康)具有持久的潛在需求。
As you consider your models, there are a few items to keep in mind. While we actively manage foreign exchange through our revenue hedging program, it continues to be a headwind to growth, particularly across products with a larger portion of international revenues, such as in our Animal Health business. The hedging program mitigates the impact of foreign exchange. And to the extent we continue to see foreign exchange headwinds recorded at the product level, we will see a benefit in other revenue. In addition, other revenue includes the supply sales to Organon.
當您考慮您的模型時,需要記住一些事項。雖然我們通過收入對沖計劃積極管理外匯,但它仍然是增長的逆風,尤其是在國際收入佔比較大的產品中,例如我們的動物保健業務。對沖計劃減輕了外彙的影響。如果我們繼續在產品層面看到外匯逆風,我們將看到其他收入的好處。此外,其他收入包括對歐加農的供應銷售。
As you saw in our results, PNEUMOVAX 23 is experiencing pressure, particularly in the U.S. as the market continues to shift towards newer adult pneumococcal conjugate vaccine. We remain committed to our capital allocation priorities. We will continue to prioritize investments in our pipeline and business to drive near- and long-term growth across our portfolio.
正如您在我們的結果中看到的那樣,PNEUMOVAX 23 正在承受壓力,尤其是在美國,因為市場繼續轉向更新的成人肺炎球菌結合疫苗。我們仍然致力於我們的資本配置優先事項。我們將繼續優先投資我們的管道和業務,以推動我們投資組合的近期和長期增長。
We have made significant progress across our pipeline, which Dean will speak to, that has the potential to drive sustainable revenue growth. We are augmenting our pipeline by pursuing the best external science through value-enhancing business development which we will invest in to realize the promise of these products.
我們已經在我們的管道上取得了重大進展,迪恩將與之交談,這有可能推動可持續的收入增長。我們通過提高價值的業務發展來追求最好的外部科學,從而擴大我們的管道,我們將投資以實現這些產品的承諾。
We continue to consider the full breadth of the business development landscape. We have ample balance sheet capacity and we will act only when science and value align. Should meaningful business development not materialize and depending on the pipeline of potential transactions, we will opportunistically buy back shares. We remain committed to our dividend, with the goal of increasing it over time.
我們繼續全面考慮業務發展格局。我們有充足的資產負債表能力,只有在科學和價值一致時才會採取行動。如果有意義的業務發展沒有實現,並且取決於潛在交易的渠道,我們將機會性地回購股票。我們仍然致力於分紅,目標是隨著時間的推移增加分紅。
To conclude, as we finish the year, we remain confident in the continued growth of our business. Global demand for our innovative medicines and vaccines remains strong, and we continue to demonstrate the operational momentum and commercial execution that will enable us to deliver value to patients and shareholders now and well into the future.
總而言之,當我們結束這一年時,我們對業務的持續增長仍然充滿信心。全球對我們的創新藥物和疫苗的需求依然強勁,我們將繼續展示運營勢頭和商業執行力,這將使我們能夠在現在和未來為患者和股東創造價值。
With that, I'd now like to turn the call over to Dean.
有了這個,我現在想把電話轉給 Dean。
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Thank you, Caroline. It's my pleasure to provide an update on our progress since the second quarter call. We are growing momentum in our pipeline across therapeutic areas, across modalities, across stages of development and across the spectrum of internal programs, established partnerships and recent business development opportunities.
謝謝你,卡羅琳。我很高興提供自第二季度電話會議以來我們的最新進展。我們在跨治療領域、跨模式、跨發展階段以及跨內部計劃、已建立的合作夥伴關係和最近的業務發展機會的範圍內的管道正在增長勢頭。
In cardiology, we are making strong headway in pulmonary arterial hypertension as well as our PCSK9 and Factor XI program. In vaccines, we are moving with rigor and speed to build on the VAXNEUVANCE approval and establish a suite of tailored pneumococcal vaccine. In oncology, we are expanding our portfolio in partnerships with Orion, Kelun, and most recently, Moderna. This progress strengthens my confidence in the pipeline and reinforces to me the opportunity presented by several candidates poised to positively impact patients' lives.
在心髒病學方面,我們在肺動脈高壓以及我們的 PCSK9 和因子 XI 計劃方面取得了重大進展。在疫苗方面,我們正在以 VAXNEUVANCE 的批准為基礎,以嚴謹和快速的方式開展工作,並建立一套量身定制的肺炎球菌疫苗。在腫瘤學領域,我們正在與 Orion、Kelun 以及最近的 Moderna 合作,擴大我們的產品組合。這一進展增強了我對管道的信心,並加強了幾位候選人提供的機會,這些候選人準備對患者的生活產生積極影響。
As Rob noted, we see significant opportunity to make an impact in cardiovascular disease. Earlier this month, we announced top line results from the Phase III STELLAR trial, evaluating sotatercept for the treatment of pulmonary arterial hypertension. Sotatercept, added to currently approved standard of care, had a profound effect on the primary efficacy outcome measure of improvement in 6-minute walk distance from baseline at 24 weeks.
正如 Rob 所指出的,我們看到了對心血管疾病產生影響的重要機會。本月早些時候,我們公佈了 III 期 STELLAR 試驗的一線結果,評估了用於治療肺動脈高壓的 sotatercept。 Sotatercept 添加到目前批准的護理標準中,對 24 週時從基線改善 6 分鐘步行距離的主要療效結果測量產生了深遠的影響。
Of note, 8 out of 9 secondary efficacy outcome measures achieved statistical significance, including the outcome measure of proportion of participants achieving multicomponent improvement and the outcome measure of time to death for the first occurrence of a clinical worsening event. We look forward to sharing the results with regulatory authorities and plan to present the findings at a scientific congress in 2023. The data from the STELLAR trial is an important milestone as we work to establish a beachhead in pulmonary arterial hypertension.
值得注意的是,9 項次要療效結果指標中有 8 項取得了統計學意義,包括參與者實現多因素改善的比例的結果指標和首次發生臨床惡化事件的死亡時間的結果指標。我們期待與監管機構分享研究結果,併計劃在 2023 年的科學大會上展示研究結果。STELLAR 試驗的數據是我們努力建立肺動脈高壓灘頭陣地的一個重要里程碑。
Looking ahead, the ZENITH trial is evaluating sotatercept for morbidity and mortality and will enable assessment of the potential to reverse progression of disease and will be followed by the HYPERION trial, which is designed to evaluate whether administration of sotatercept earlier in the course of PAH can help improve outcomes and delay time to clinical worsening. And we also have a Phase II CADENCE trial, which is exploring the potential for sotatercept in left heart failure.
展望未來,ZENITH 試驗正在評估 sotatercept 的發病率和死亡率,並將能夠評估逆轉疾病進展的潛力,隨後將進行 HYPERION 試驗,該試驗旨在評估在 PAH 過程中早期給予 sotatercept 是否可以有助於改善結果並延遲臨床惡化的時間。我們還有一項 II 期 CADENCE 試驗,正在探索 sotatercept 在左心衰竭中的潛力。
In addition to sotatercept, we are studying MK-5475, an investigational inhaled soluble guanylate cyclase stimulator designed to provide selective pulmonary arterial dilatation with limited systemic exposure for the treatment of PAH. We remain confident in the promise of our investigational portfolio to fundamentally change the treatment of pulmonary arterial hypertension.
除了 sotatercept,我們還在研究 MK-5475,這是一種研究性吸入可溶性鳥苷酸環化酶刺激劑,旨在提供選擇性肺動脈擴張,全身暴露有限,用於治療 PAH。我們仍然對我們的研究組合從根本上改變肺動脈高壓治療的承諾充滿信心。
Next, to LAGEVRIO. Approximately 2.5 million people have now received LAGEVRIO for the treatment of COVID-19, and studies are continuing to show the impact this oral treatment option is having on patients and on the health care system. Real-world evidence of high-risk, older population conducted in Israel and Hong Kong found a reduction in hospitalization and death, consistent with the Phase III MOVe-OUT clinical trial.
接下來,到 LAGEVRIO。現在約有 250 萬人接受了 LAGEVRIO 治療 COVID-19,研究繼續顯示這種口服治療方案對患者和醫療保健系統的影響。在以色列和香港進行的高風險老年人群的真實世界證據發現,住院和死亡人數減少,這與 III 期 MOVe-OUT 臨床試驗一致。
Unsurprisingly, a large study in the U.K. evaluating a broader, highly-vaccinated population conducted during the Omicron era found no difference in hospitalization versus standard of care. Nevertheless, there were important observations from certain secondary analysis, including quicker time to recovery and to symptom alleviation as well as reduced physician visits. LAGEVRIO continues to demonstrate a safety profile consistent with our findings in MOVe-OUT.
不出所料,英國的一項大型研究評估了在 Omicron 時代進行的更廣泛、高度接種疫苗的人群,發現住院與護理標準沒有差異。然而,從某些二次分析中發現了重要的觀察結果,包括更快的恢復時間和症狀緩解以及減少就診次數。 LAGEVRIO 繼續展示與我們在 MOVe-OUT 中的發現一致的安全概況。
The pandemic continues to evolve and vaccination rates still vary substantially from country to country. More reason variants, such as Omicron, are generally associated with less severe disease. But the elderly and those with comorbidities remain at high risk of poor outcome. Insights from real-world studies are important in this context as we try to understand how LAGEVRIO is being used and the potential benefit for various patient populations.
大流行繼續發展,各國的疫苗接種率仍然存在很大差異。更多原因變體,例如 Omicron,通常與不太嚴重的疾病有關。但老年人和有合併症的人仍然面臨預後不良的高風險。在這方面,來自現實世界研究的見解很重要,因為我們試圖了解 LAGEVRIO 的使用方式以及對各種患者群體的潛在益處。
LAGEVRIO continues to be an important tool in the armamentarium to treat COVID-19, especially with uncertainty surrounding the emergence of new variants and continued global surges. In addition to COVID-19, we are now taking steps to harness the broad antiviral potential of LAGEVRIO. We have initiated a Phase II trial evaluating its use in the treatment of respiratory syncytial virus and will provide further updates as they become available.
LAGEVRIO 仍然是治療 COVID-19 的重要工具,特別是在新變種出現和全球持續激增的不確定性的情況下。除了 COVID-19,我們現在正在採取措施利用 LAGEVRIO 的廣泛抗病毒潛力。我們已經啟動了一項 II 期試驗,評估其在治療呼吸道合胞病毒中的用途,並將在可用時提供進一步的更新。
Shifting to our HIV portfolio. Since last year's setback to the islatravir program, we have gained tremendous learning and insights through the evaluation of data. Following consultation with the FDA, we are pleased we have a path forward. We initiated a new Phase III clinical program evaluating a once-daily oral combination of doravirine and a lower dose of islatravir for the treatment of people with HIV-1 infection.
轉向我們的 HIV 產品組合。自去年 islatravir 計劃受挫以來,我們通過數據評估獲得了巨大的學習和見解。在與 FDA 協商後,我們很高興我們有前進的道路。我們啟動了一項新的 III 期臨床計劃,評估每日一次口服多拉韋林和較低劑量的伊拉曲韋治療 HIV-1 感染者的組合。
In addition, the Phase II study with Gilead evaluating a weekly oral combination treatment regimen of islatravir and lenacapavir in adults with HIV-1 infection who are virologically suppressed is resuming with a lower dose of islatravir.
此外,與吉利德(Gilead)進行的 II 期研究評估了艾拉曲韋和來那卡韋對病毒學抑制的 HIV-1感染成人的每周口服聯合治療方案,該研究正在恢復使用較低劑量的艾拉曲韋。
We continue to see significant potential in the nucleoside reverse transcriptase translocation inhibitor mechanism and remain committed to addressing the unmet need in both treatment and in prevention of HIV. In the prep setting, we are prioritizing an internal novel NRTTI compound for development, next to vaccine and specifically GARDASIL 9.
我們繼續看到核苷逆轉錄酶易位抑製劑機制的巨大潛力,並繼續致力於解決 HIV 治療和預防方面未滿足的需求。在準備工作中,我們優先考慮開發一種內部新型 NRTTI 化合物,僅次於疫苗,特別是 GARDASIL 9。
As Caroline noted, last month, the National Medical Products Administration in China expanded the authorization for GARDASIL 9 to a broader age range. The authorization reinforces the strong clinical profile of GARDASIL 9 and its effectiveness in preventing certain types of HPV-related cancers and diseases.
正如 Caroline 所指出的,上個月,中國國家藥品監督管理局將 GARDASIL 9 的授權範圍擴大到了更廣泛的年齡範圍。該授權加強了 GARDASIL 9 的強大臨床特徵及其在預防某些類型的 HPV 相關癌症和疾病方面的有效性。
In addition, we were pleased with the recent approval of VAXNEUVANCE, our 15-valent pneumococcal conjugate vaccine by the European Commission in the pediatric calculation. This approval brings an important treatment option to vulnerable populations, including infants less than 1 year of age, who typically experience the highest rate of disease.
此外,我們很高興最近在兒科計算中批准了我們的 15 價肺炎球菌結合疫苗 VAXNEUVANCE。該批准為弱勢群體帶來了重要的治療選擇,包括通常患病率最高的 1 歲以下嬰兒。
I would also like to touch on the recently announced collaboration with Orna Therapeutics. We have made significant investments and gained important insights into the use of RNA technology. The compelling circular RNA platform that Orna has developed allows us to explore the potential for a new generation of vaccines and therapeutics.
我還想談談最近宣布的與 Orna Therapeutics 的合作。我們對 RNA 技術的使用進行了大量投資並獲得了重要的見解。 Orna 開發的引人注目的環狀 RNA 平台使我們能夠探索新一代疫苗和療法的潛力。
Turning to oncology. Strong momentum continues in our oncology portfolio across tumor types and stages of disease. Last month, at the European Society for Medical Oncology Meeting, we showcased long-term survival benefit data for KEYTRUDA in non-small cell lung cancer, melanoma and head and neck cancer as well as for Lynparza in ovarian cancer. In addition, we presented data that continues to support the potential of KEYTRUDA in earlier-stage disease. Our expansive research efforts in treating in earlier-stage settings reflects our ambition to treat cancer when the potential of curing cancer may be high.
轉向腫瘤學。我們在腫瘤類型和疾病階段的腫瘤學產品組合繼續保持強勁勢頭。上個月,在歐洲醫學腫瘤學會會議上,我們展示了 KEYTRUDA 在非小細胞肺癌、黑色素瘤和頭頸癌以及 Lynparza 在卵巢癌中的長期生存獲益數據。此外,我們提供的數據繼續支持 KEYTRUDA 在早期疾病中的潛力。我們在早期階段治療方面的廣泛研究努力反映了我們在治愈癌症的潛力可能很高時治療癌症的雄心。
Also at ESMO, in collaboration with Seagen and Astellas, first-time data was presented from the Phase Ib/II EV-103 for KEYNOTE-869 Cohort K trial. KEYTRUDA plus enfortumab vedotin-ejfv demonstrated encouraging objective response rate as a first-line treatment in patients with unresectable, locally advanced, metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. There remains a high unmet medical need for new medicines for the treatment of locally advanced or metastatic bladder cancer, and we look forward to the potential of this combination.
同樣在 ESMO,與 Seagen 和 Astellas 合作,首次提供了 Ib/II 期 EV-103 用於 KEYNOTE-869 Cohort K 試驗的數據。 KEYTRUDA 加 enfortumab vedotin-ejfv 顯示出令人鼓舞的客觀緩解率,作為無法接受以順鉑為基礎的化療的不可切除、局部晚期、轉移性尿路上皮癌患者的一線治療。對於治療局部晚期或轉移性膀胱癌的新藥,仍有很高的醫療需求未得到滿足,我們期待這種組合的潛力。
This quarter, we received priority review for Lynparza in combination with abiraterone as first-line treatment for patients with metastatic castration resistant prostate cancer regardless of their genetic mutational status based on the PROpel study. The PDUFA date has been set for the fourth quarter.
本季度,我們收到優先審查 Lynparza 聯合阿比特龍作為轉移性去勢抵抗性前列腺癌患者的一線治療,無論其基於 PROpel 研究的基因突變狀態如何。 PDUFA 日期已確定為第四季度。
Outside of the U.S., we continue to deliver on our oncology strategy. There remains significant opportunity for us to help improve patient outcomes and address unmet need in Japan and in China. We received 4 new approvals in Japan based on KEYNOTE-522 for KEYTRUDA in combination with chemotherapy in neoadjuvant, adjuvant, high-risk, early-stage triple-negative breast cancer; KEYNOTE-564 for the adjuvant treatment of certain patients with renal cell carcinoma following surgery; KEYNOTE-716 for the adjuvant treatment of certain patients 12 years and older with completely resected Stage 2b or Stage 2C melanoma; and KEYNOTE-826 for KEYTRUDA in combination with chemotherapy, with or without bevacizumab in certain patients with advanced or recurrent cervical cancer.
在美國以外,我們繼續實施我們的腫瘤學戰略。我們仍有重要的機會幫助改善日本和中國的患者治療效果並解決未滿足的需求。我們在日本獲得了 4 項基於 KEYNOTE-522 的 KEYTRUDA 與化療聯合用於新輔助、輔助、高危、早期三陰性乳腺癌的新批准; KEYNOTE-564用於某些腎細胞癌術後患者的輔助治療; KEYNOTE-716用於輔助治療某些 12 歲及以上完全切除的 2b 期或 2C 期黑色素瘤患者; KEYNOTE-826 用於 KEYTRUDA 聯合化療,在某些晚期或複發性宮頸癌患者中聯合或不聯合貝伐單抗。
For Lynparza, we received approvals in the EU and Japan for the adjuvant treatment for patients with certain types of high-risk, early-stage breast cancer based on the OlympiA trial and in China as first-line maintenance treatment for patients with advanced ovarian cancer.
對於 Lynparza,我們在歐盟和日本獲得批准,用於基於 OlympiA 試驗對某些類型的高危早期乳腺癌患者進行輔助治療,並在中國作為晚期卵巢癌患者的一線維持治療獲得批准.
Finally, we exercised our option to jointly develop a personalized cancer vaccine, mRNA-4157, or V940, which our partner, Moderna, is currently evaluating in combination with KEYTRUDA in a Phase II study for patients with locally advanced and resected melanoma. The primary objective of the Phase II study is to test efficacy of a personalized cancer vaccine plus KEYTRUDA versus KEYTRUDA alone in a randomized study of early-stage melanoma in the adjuvant setting. We are energized to continue our collaboration with Moderna, a pioneer in mRNA vaccine technology.
最後,我們行使了共同開發個性化癌症疫苗 mRNA-4157 或 V940 的選擇權,我們的合作夥伴 Moderna 目前正在聯合 KEYTRUDA 對局部晚期和切除的黑色素瘤患者進行 II 期研究。 II 期研究的主要目的是在輔助環境中早期黑色素瘤的隨機研究中測試個性化癌症疫苗加 KEYTRUDA 與單獨 KEYTRUDA 的療效。我們有動力繼續與 mRNA 疫苗技術的先驅 Moderna 合作。
To conclude, there has been substantive progress across our pipeline, and I look forward to providing further updates on our progress in the future. And now I will turn the call back to Peter.
總而言之,我們的管道取得了實質性進展,我期待在未來提供有關我們進展的進一步更新。現在我將把電話轉回給彼得。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thank you, Dean. Lia, will you please start the Q&A. (Operator Instructions)
謝謝你,院長。莉亞,請你開始問答吧。 (操作員說明)
Operator
Operator
(Operator Instructions) And our first question is from Chris Schott with JPMorgan.
(操作員說明)我們的第一個問題來自摩根大通的 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
I guess my question was on capital deployment. I think you mentioned in the prepared remarks that if BD doesn't materialize based on the progression of the pipeline, you'd consider repo at some point down the line. So I guess on that front, how are you thinking about the overall business development landscape at this point? And has your preference on -- or, I guess, actionability of kind of larger deals versus Acceleron-type tuck-ins evolved at all as we've gone through this year?
我想我的問題是關於資本部署。我想你在準備好的評論中提到,如果 BD 沒有根據管道的進展實現,你會考慮在某個時候進行回購。所以我想在這方面,您現在如何看待整體業務發展前景?在我們今年經歷的過程中,您是否偏愛——或者,我猜,與 Acceleron 類型的折舊交易相比,更大交易的可操作性是否發生了變化?
I know it's obviously a big kind of point of debate on the Merck story. So I'd just love to hear kind of latest thinking on your kind of BD landscape. And are we getting closer to a point where maybe repo makes sense just given the cash that seems to be kind of accumulating at the company?
我知道這顯然是關於默克公司故事的一大爭論點。所以我很想听聽你對 BD 領域的最新想法。考慮到公司似乎在積累現金,我們是否越來越接近回購可能有意義的地步?
Robert M. Davis - President, CEO & Director
Robert M. Davis - President, CEO & Director
Yes. Great, Chris. Thanks for the question, and I'll ask Caroline to comment specifically on the share repurchase side of the question. But just to the BD landscape, we continue to, frankly, see a portfolio of opportunities we are interested in and are continuing to look at. So as we sit here today, our focus, our urgency on business development has not changed. We do see a list of potential places to play.
是的。太好了,克里斯。感謝您提出問題,我將請 Caroline 就問題的股票回購方面做出具體評論。但就 BD 領域而言,坦率地說,我們繼續看到我們感興趣並繼續關注的一系列機會。因此,當我們今天坐在這裡時,我們的重點,我們對業務發展的緊迫性並沒有改變。我們確實看到了潛在的遊戲地點列表。
Obviously, we've got to bring them through to fruition which we're working to do. But that is our priority because we continue to believe the best thing we can do for long-term value creation is to invest in the sustainability of our business, which is investing in the pipeline of the future in both what we do internally and through BD. So that's our priority. And I do see opportunities, but obviously, we remain committed also to not hold cash.
顯然,我們必須讓它們實現我們正在努力做的事情。但這是我們的首要任務,因為我們仍然相信我們能為長期價值創造做的最好的事情是投資於我們業務的可持續性,即投資於我們在內部和通過 BD 所做的未來管道.所以這是我們的首要任務。我確實看到了機會,但顯然,我們仍然致力於不持有現金。
So with that, maybe I'll let Caroline comment specifically on the share repurchase.
因此,也許我會讓卡羅琳專門評論股票回購。
Caroline Litchfield - Executive VP & CFO
Caroline Litchfield - Executive VP & CFO
So Chris, our capital allocation priorities are unchanged. We seek to provide a competitive return to our shareholders through both the dividend that we pay and we expect will grow, as well as through share repurchases, while we balance the need to invest in our business in driving growth, as well as in our business development strategies, as Robert just outlined. Given where we are, with our focus on business development, our desire to not create excess cash on the balance sheet, we will look opportunistically at share buybacks based on our assessment of that BD pipeline.
所以克里斯,我們的資本分配優先級沒有改變。我們尋求通過我們支付且我們預期將增長的股息以及通過股票回購為我們的股東提供有競爭力的回報,同時我們平衡投資於我們的業務以推動增長以及我們的業務的需求正如羅伯特剛剛概述的那樣。鑑於我們所處的位置,我們專注於業務發展,我們希望不在資產負債表上創造過多的現金,我們將根據我們對 BD 管道的評估機會主義地看待股票回購。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Great. Thank you, Chris. Next question, please, Lia.
偉大的。謝謝你,克里斯。下一個問題,Lia。
Operator
Operator
Next question is from Daina Graybosch with SVB Securities.
下一個問題來自 SVB 證券的 Daina Graybosch。
Daina Michelle Graybosch - Senior MD of Immuno-Oncology and Senior Research Analyst
Daina Michelle Graybosch - Senior MD of Immuno-Oncology and Senior Research Analyst
Yes. I wonder if you could talk a little bit more about your novel pneumococcal vaccine strategy, V116 and V117 and how you think that will compete ultimately with competitor vaccines that continue to increase in their serotype valency?
是的。我想知道您是否可以多談談您的新型肺炎球菌疫苗策略,V116 和 V117,以及您認為這最終將如何與血清型效價持續增加的競爭對手疫苗競爭?
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
This is Dean, I'll take that, and thank you very much for the question. So the top line is, I would just emphasize that our view is that more serotype is not always better and one size does not fit all. Our view, and the view that I've had when I practiced medicine, it's the right medicine or, in this case, the right vaccine for the right patient at the right time.
我是 Dean,我會接受的,非常感謝你的提問。所以最重要的是,我只想強調我們的觀點是,血清型越多並不總是越好,一種尺寸並不適合所有人。我們的觀點,以及我行醫時的觀點,它是正確的藥物,或者在這種情況下,是在正確的時間為正確的患者提供正確的疫苗。
So when you look at VAXNEUVANCE, which is our 15-valent, which has (inaudible) responses for serotype 3, but also 22F and 33F. If you look at that and you have to look at the epidemiology of pneumococcal disease and it's a bimodal curve where really in the first 2 years of life, especially in the first year of life, is really important. And then in the adult section, you realize that there's increasing at 45, 55, 65. So there's a bimodal curve. If you also lay down the different serotypes, the serotypes are quite different between the 2. So that's why we believe it's the right vaccine for the right patient at the right time.
因此,當您查看 VAXNEUVANCE 時,它是我們的 15 價,它對血清型 3 以及 22F 和 33F 有(聽不清)反應。如果你看一下,你必須看看肺炎球菌病的流行病學,它是一個雙峰曲線,在生命的頭兩年,尤其是生命的第一年,真的很重要。然後在成人部分,你意識到在 45、55、65 歲時有增加。所以有一個雙峰曲線。如果您還確定了不同的血清型,那麼兩者之間的血清型完全不同。這就是為什麼我們認為它是在正確的時間為正確的患者提供正確的疫苗。
Now we have a pediatric V114 that has ACIP that's gone through. And in terms of differentiation and relationship to pediatrics, we don't have clear view of other vaccines, but we are very confident in our ability to give coverage in the first year. And data to date might suggest that, that is an important differentiation in a pediatric study.
現在我們有一個經過 ACIP 的兒科 V114。而且在分化和與兒科的關係方面,我們對其他疫苗沒有清晰的認識,但我們對第一年提供覆蓋的能力非常有信心。迄今為止的數據可能表明,這是兒科研究中的一個重要區別。
There is some questions in relationship to top line serotypes that's been sort of laid out. There's been some discussion of 6 [mix] serotypes, too substantial, we can't really comment on that differentiation until we know exactly what serotypes and what the real detailed data is.
有一些與頂級血清型有關的問題已經被列出。有一些關於 6 種 [混合] 血清型的討論,太重要了,在我們確切地知道什麼是血清型以及真正的詳細數據是什麼之前,我們無法真正評論這種差異。
In relationship to the adult market, this gives us great insight and great enthusiasm for V116, our 21-valent vaccine. Now that one is specifically targeted for the serotypes that are important for the adults. So it's 21-valent, but I would just emphasize that 11 serotypes in the 21-valent for V116 is not shared by PCV20. And the reason is that we're focused on the adult disease, and we are targeting 85% of residual invasive pneumococcal disease.
就成人市場而言,這讓我們對我們的 21 價疫苗 V116 產生了深刻的洞察力和熱情。現在,它專門針對對成年人很重要的血清型。所以它是 21 價,但我只想強調 V116 的 21 價中的 11 种血清型不被 PCV20 共享。原因是我們專注於成人疾病,我們的目標是 85% 的殘留侵襲性肺炎球菌疾病。
And I would -- if I look at the vaccines that are in Phase III, but also Phase II or Phase I with recent data, I don't know that anyone else has a vaccine that's targeting 85% of the residual invasive pneumococcal disease. So more is not better, one size does not fit all. It's the right vaccine, the right patient at the right time.
而且我會 - 如果我查看處於 III 期以及 II 期或 I 期的疫苗以及最近的數據,我不知道其他人有針對 85% 殘留侵襲性肺炎球菌疾病的疫苗。所以更多並不是更好,一種尺寸並不適合所有人。這是正確的疫苗,在正確的時間出現在正確的患者身上。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thank you, Daina. Next question, please, Lia.
謝謝你,戴娜。下一個問題,Lia。
Operator
Operator
Next is Colin Bristow with UBS.
接下來是瑞銀的科林布里斯托。
Colin Nigel Bristow - Analyst
Colin Nigel Bristow - Analyst
Congrats on the results. A great quarter for GARDASIL, but you talk about the -- sort of the onetime impact of CDC purchase timing. Can you just quantify the level of impact that had? And then I just wanted to touch base on the additional supply coming online in '23, '24 and '25. Is this still on track? And could you just specify where the supply is coming from geographically?
祝賀結果。對於 GARDASIL 來說,這是一個很棒的季度,但您談論的是 CDC 購買時間的一次性影響。你能量化一下影響的程度嗎?然後我只想談談 23 年、24 年和 25 年上線的額外供應。這還在軌道上嗎?你能具體說明供應的地理來源嗎?
Caroline Litchfield - Executive VP & CFO
Caroline Litchfield - Executive VP & CFO
This is Caroline. I'll take a shot at answering your question. So GARDASIL still continues to be a very strong growth driver for our company and will be long into the future given to date only 9% of the world's eligible population are vaccinated.
這是卡羅琳。我會試著回答你的問題。因此,GARDASIL 仍然是我們公司非常強勁的增長動力,而且在未來很長一段時間內,迄今為止全球只有 9% 的合格人口接種了疫苗。
In terms of the quarter results, we saw growth in the U.S., which was largely driven by the CDC timing. In the third quarter of 2021, there was an approximate $125 million buy-in by the CDC. In the third quarter of '22, there was an approximate buy-in of $250 million. So year-over-year, that contributed to growth to the tune of approximately $120 million plus. We do expect the majority of that buy-in by the CDC in the third quarter to come out during the fourth quarter.
就季度業績而言,我們看到了美國的增長,這在很大程度上是由 CDC 的時機推動的。在 2021 年第三季度,CDC 獲得了大約 1.25 億美元的支持。在 22 年第三季度,大約有 2.5 億美元的買入。因此,與去年同期相比,這促成了大約 1.2 億美元以上的增長。我們確實預計 CDC 在第三季度的大部分支持將在第四季度出現。
As we look at our opportunity to satisfy the global demand and protect as many lives as we can going forward, we will be supported by the increased supply and capacity that we have coming online commencing 2023. And we expect that, that additional supply will come online over the course of '23, '24 and '25. And therefore, we remain very confident in our ability to protect more lives, to drive growth long into the future, including doubling the revenue of GARDASIL in the year 2030 compared to where we were in 2021.
當我們看到滿足全球需求並保護盡可能多的生命的機會時,我們將得到從 2023 年開始在線增加的供應和容量的支持。我們預計,額外的供應將會到來在 '23、'24 和 '25 期間在線。因此,我們仍然對我們保護更多生命、推動未來長期增長的能力充滿信心,包括在 2030 年將 GARDASIL 的收入與 2021 年相比翻一番。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Great. Thank you, Colin. Next question, please, Lia.
偉大的。謝謝你,科林。下一個問題,Lia。
Operator
Operator
Next is Seamus Fernandez with Guggenheim.
接下來是古根海姆的 Seamus Fernandez。
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
So I really wanted to ask a question on sotatercept and perhaps the endpoints that surprised you the most. The feedback that we're getting from thought leaders is that the benefit on clinical worsening actually coming as early as it did was a genuine surprise and suggests upside. Just wondering, Dean, where you fit in that point of discussion and perhaps what you're looking forward to in some of the earlier-stage clinical studies for sotatercept?
所以我真的很想問一個關於 sotatercept 的問題,也許是最讓你驚訝的端點。我們從思想領袖那裡得到的反饋是,臨床惡化的好處實際上早在它發生的時候就出現了,這是一個真正的驚喜,並暗示了上行空間。只是想知道,Dean,您在討論中的位置,以及您在 sotatercept 的一些早期臨床研究中期待什麼?
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Thank you very much for that question. So yes, we gave top line results. We're moving with speed to present those data to regulatory authorities throughout.
非常感謝你提出這個問題。所以是的,我們給出了最重要的結果。我們正在迅速向監管機構提供這些數據。
But just to step back, I just want to remind, at least myself and every -- and others that we were drawn to the sotatercept mechanism because it was a unique mechanism of action. It's to rebalance active BNP signaling.
但退一步說,我只想提醒,至少我自己和每個人——以及其他人,我們被 sotatercept 機制所吸引,因為它是一種獨特的作用機制。這是為了重新平衡活躍的 BNP 信號。
The other mechanisms of action could largely be viewed as vasodilatory, and we have a very strong program in trying to make the best vasodilatory medicine. But the mechanism of action you would expect for sotatercept, you would expect it would potentially reprogram the cellular response and essentially be disease modifying.
其他作用機制在很大程度上可以被視為血管擴張,我們有一個非常強大的計劃來嘗試製造最好的血管擴張藥物。但是您對 sotatercept 的預期作用機制,您會預期它可能會重新編程細胞反應,並且基本上可以改變疾病。
We are excited about the results. We note that there was a profound effect on 6-minute walk. But as you emphasized, time to clinical worsening, these multi-components are all really important and they came in clinically meaningful and statistically significant. So we are hopeful that we can potentially reshape the treatment of PAH.
我們對結果感到興奮。我們注意到,步行 6 分鐘產生了深遠的影響。但正如你所強調的,臨床惡化的時間,這些多因素都非常重要,它們具有臨床意義和統計學意義。因此,我們希望我們有可能重塑 PAH 的治療方法。
I would emphasize that we talk about HYPERION, ZENITH and CADENCE. But the level of interest that I have in this program is I would point us often to [Secura], which is the follow-on program. And the reason why that is really important to me is given the results that I see, I very much want the individuals who were on the STELLAR trial to have the opportunity to get into Secura, which is an open-label trial, because the effects that we see that will be reported in a meeting likely in 2023 are ones where we must make sure that those individuals who were recruited to STELLAR have continued access to sotatercept. That's how important we think the results are.
我要強調的是,我們談論的是 HYPERION、ZENITH 和 CADENCE。但是我對這個程序的興趣程度是我經常向我們指出 [Secura],它是後續程序。鑑於我看到的結果,這對我來說真的很重要,我非常希望參加 STELLAR 試驗的人有機會進入 Secura,這是一項開放標籤試驗,因為效果我們看到可能在 2023 年的一次會議上報告,我們必須確保那些被招募到 STELLAR 的人能夠繼續獲得 sotatercept。這就是我們認為結果的重要性。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thank you, Seamus. Next question, please, Lia.
謝謝你,西莫。下一個問題,Lia。
Operator
Operator
Next is Steve Scala with Cowen.
接下來是史蒂夫·斯卡拉(Steve Scala)和考恩(Cowen)。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
Rob, you have been CEO for 16 months, and now you're going to be Chairman. What do you view as your greatest accomplishments during this time? And what have been the greatest disappointments? I think given the comments you made when you took over, we might have expected more to be done more quickly to build the pipeline, especially since Merck's pipeline is the second smallest in global pharma. Do you think this is a fair assertion? And if so, why haven't things changed more quickly?
Rob,您擔任 CEO 已有 16 個月,現在您將擔任董事長。你認為這段時間你最大的成就是什麼?最大的失望是什麼?我認為,鑑於您接手時發表的評論,我們可能期望更快地完成更多工作以建立管道,特別是因為默克的管道是全球製藥業中第二小的管道。你認為這是一個公平的斷言嗎?如果是這樣,為什麼事情沒有更快地改變?
Robert M. Davis - President, CEO & Director
Robert M. Davis - President, CEO & Director
Yes, no, Steve, thanks for the question. Obviously, it's been a fast 6 months -- or 16 months in the role. But I'd say what I'm most proud of, several things. One, the way the organization has come together as one team and really brought more focus in the business. Obviously, the spin-off of Organon, I think, was very successful, has given us more simple structures, more focus that I feel very good about. Our progress on business development, obviously, the fact that we moved so quickly with Acceleron and then you heard what are just really exceptional results coming out of the STELLAR study, very -- feel very proud about.
是的,不,史蒂夫,謝謝你的提問。顯然,這是一個快速的 6 個月——或 16 個月的角色。但我要說幾件我最自豪的事。一,組織作為一個團隊聚集在一起的方式,真正帶來了對業務的更多關注。顯然,我認為,奧加農的分拆非常成功,給了我們更簡單的結構,更多的專注,我覺得非常好。顯然,我們在業務發展方面取得的進展,我們與 Acceleron 合作如此迅速,然後您聽到了 STELLAR 研究得出的非常出色的結果,非常 - 感到非常自豪。
But I would say also just overall the way our team has continued to just execute really flawlessly, scientifically, operationally, commercially, I couldn't be prouder of what everyone is doing. We've come together and we're really delivering. For all of those things, I would say I'm very proud about.
但我還要說,總體而言,我們的團隊繼續以完美無瑕的方式繼續執行,在科學、運營、商業上,我為每個人所做的事情感到無比自豪。我們走到了一起,我們真的在交付。對於所有這些事情,我會說我為此感到非常自豪。
On the pipeline itself, I actually think we're making a lot of progress. The fact that a year ago, won't even give us credit for having a cardiovascular pipeline. And today, we talk about the fact that by the '24 to '28 time frame, we could be having as many as 8 new approvals driving revenue that could be in excess of $10 billion by the mid-2030s across the whole suite of assets, some developed internally and obviously some brought into business development, like what we did with Acceleron. So I feel very good about that.
在管道本身上,我實際上認為我們正在取得很大進展。一年前的事實甚至不會讓我們相信擁有心血管管道。今天,我們談到了這樣一個事實,即到 24 到 28 年的時間框架內,我們可能會獲得多達 8 個新的批准,從而推動整個資產套件的收入到 2030 年代中期可能超過 100 億美元,有些是內部開發的,有些顯然是引入業務開發的,就像我們對 Acceleron 所做的那樣。所以我對此感覺很好。
The progress we're making in vaccines, what we're seeing. I think VAXNEUVANCE is underappreciated, this notion that Dean made out of really having a bespoke approach where we were able to cover more of the serotypes that cause disease, whether it be in infants, and then selectively and differently, those in adults. We think that's a real game changer. Our growing pipeline in neuroscience and immunology, I could go on and on, and the strength that we're continuing to have in adding to our oncology pipeline.
我們在疫苗方面取得的進展,我們所看到的。我認為 VAXNEUVANCE 被低估了,這個想法是 Dean 真正採用定制方法提出的,我們能夠覆蓋更多導致疾病的血清型,無論是在嬰兒中,然後是選擇性地和不同地在成人中。我們認為這是一個真正的遊戲規則改變者。我們在神經科學和免疫學方面不斷增長的管道,我可以繼續下去,以及我們在增加我們的腫瘤管道方面繼續擁有的實力。
So do I think we have everything we need? No. But do I think we've made great progress in a year? I actually think we have, and it gives me confidence that we're going to continue -- to continue to drive progress. The fact that we did 3 important business development deals this quarter alone, spanning mRNA technologies into circular RNA technologies, personalized cancer vaccines and then more traditional oncology agents with a really novel mechanism, those all are adding to the future promise we have in this company. So I actually feel very good about that. More to do, but confidence in what we've done so far.
那麼我認為我們擁有我們需要的一切嗎?不,但我認為我們在一年內取得了很大進展嗎?實際上,我認為我們已經做到了,這讓我相信我們將繼續 - 繼續推動進步。事實上,僅本季度我們就完成了 3 項重要的業務開發交易,從 mRNA 技術到環狀 RNA 技術、個性化癌症疫苗以及具有真正新穎機制的更傳統的腫瘤藥物,這些都增加了我們對這家公司的未來承諾.所以我實際上對此感覺很好。還有更多工作要做,但對我們迄今為止所做的工作充滿信心。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thank you, Steve. Next question, please, Lia.
謝謝你,史蒂夫。下一個問題,Lia。
Operator
Operator
Next is Mara Goldstein with Mizuho.
接下來是瑞穗的瑪拉·戈爾茨坦。
Mara Goldstein - MD of Equity Research Department
Mara Goldstein - MD of Equity Research Department
Great. I wanted to ask about the cardiovascular business actually since it was just mentioned. And given the pending applications for sotatercept, where you feel that, that organization from a commercial perspective needs to go. Or are you rightsized to be able to launch and maximize sotatercept in the near term?
偉大的。我想問一下心血管業務,因為剛剛提到它。鑑於 sotatercept 的未決申請,您認為從商業角度來看,該組織需要去哪裡。或者您是否能夠在短期內推出和最大化 sotatercept?
Robert M. Davis - President, CEO & Director
Robert M. Davis - President, CEO & Director
Yes. Maybe I can start that and Caroline or Dean can add on. If you look -- if you go back in history, Merck has actually had a strong history and legacy in cardiovascular. And a lot of the -- if you will, the muscle memory still exists in our organization. So I'm very confident that we have what it takes.
是的。也許我可以開始,Caroline 或 Dean 可以加入。如果你看——如果你回顧歷史,默克實際上在心血管領域有著悠久的歷史和遺產。很多——如果你願意的話,肌肉記憶仍然存在於我們的組織中。因此,我非常有信心我們擁有所需的一切。
But more importantly, we are already out there right now in PAH. We have Adempas, we have Verquvo, so we have people calling on these doctors. Recall what drove us to think about Acceleron was what we saw in our pipeline, but also what we saw commercially through that experience. So we do have the capabilities.
但更重要的是,我們現在已經在 PAH 中了。我們有 Adempas,我們有 Verquvo,所以我們有人在拜訪這些醫生。回想一下,促使我們思考 Acceleron 的是我們在管道中看到的東西,以及我們通過那次經歷在商業上看到的東西。所以我們確實有能力。
And also the other thing I'd point out is this is a little different than the way we used to think about the world. This is -- in many cases, a lot of these drugs are still specialty drugs. They're not necessarily the true, traditional, primary care drugs of what we've seen in the past. And I think we're very well positioned. So I have no worries about our confidence and ability to deliver this commercially. We've done it in the past, and we'll do it again.
我還要指出的另一件事是,這與我們過去思考世界的方式有點不同。這是 - 在許多情況下,這些藥物中的許多仍然是特殊藥物。它們不一定是我們過去看到的真正的、傳統的初級保健藥物。我認為我們的定位非常好。因此,我不擔心我們在商業上實現這一目標的信心和能力。我們過去做過,我們會再做一次。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Great. Thank you, Mara. Next question, please, Lia.
偉大的。謝謝你,瑪拉。下一個問題,Lia。
Operator
Operator
Next is Umer Raffat with Evercore.
接下來是 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
I wanted to touch up on oncology trials, 2 of them in particular. There's an ongoing subcu KEYTRUDA trial versus IV. I just -- I was curious to gauge your confidence in that and if it's reasonable to assume that vast majority of the franchise that gets switched to subcu. And also this KEYTRUDA plus KRASG12C trial, curious if the early experience implies such a combination is feasible or not?
我想補充一下腫瘤學試驗,特別是其中的 2 個。正在進行 subcu KEYTRUDA 試驗與 IV。我只是 - 我很好奇你對此的信心,以及假設絕大多數特許經營權轉向 subcu 是否合理。還有這次KEYTRUDA加KRASG12C的試驗,好奇早期的經驗暗示這樣的組合是否可行?
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
I'll take a shot at both of those questions. I'll just emphasize that there is a continuing move to early cancer throughout the field, but especially at Merck. We've talked about the approvals that we have in the early stage, both for Lynparza and KEYTRUDA. And this recent Merck-Moderna collaboration is to extend that. It's essentially an IO-IO combination, initially in melanoma, but with the possibility to expand, deepen and extend throughout other tumor types in different stages.
這兩個問題我都會一一解答。我要強調的是,整個領域都在繼續向早期癌症轉移,尤其是在默克公司。我們已經討論了我們在早期階段對 Lynparza 和 KEYTRUDA 的批准。而最近的默克與現代合作將擴展這一點。它本質上是一種 IO-IO 組合,最初用於黑色素瘤,但有可能在不同階段擴展到其他腫瘤類型。
So given that, the critical thing for patients, especially in the early stage, is to be able to have really excellent access to our medicines, and there is a need for scientific innovation. That is why we're advancing the subcu program. And we are confident that, that will not only be important and successful, but it will be really critical as we move into early phase because the ability cannot be linked to an infusion center of (inaudible). So we are confident in our strategy of moving into early phase, and it is linked, each scientific innovation required to improve access.
因此,考慮到這一點,對於患者來說,尤其是在早期階段,關鍵是能夠真正獲得我們的藥物,並且需要科學創新。這就是我們推進 subcu 計劃的原因。我們相信,這不僅重要且成功,而且隨著我們進入早期階段,這將非常關鍵,因為該能力無法與(聽不清)的輸液中心相關聯。因此,我們對進入早期階段的戰略充滿信心,並且每一項科學創新都與提高可及性所需的每一項科學創新相關聯。
In relationship with the RAS program, I have said previously that the RAS program of all of those who are advancing will require a combination. And the ability to move those programs such that you can have a dose and an ability to combine with other medicines is important. We have early data with our RAF inhibitor and many of the attributes that we think are required for that. We are big that the cards are looking like they could positively reflect on our KRAS program. But we'll share that data, both in monotherapy and in combination with pembrolizumab at an appropriate time when we present that at a conference.
關於 RAS 計劃,我之前說過,所有正在推進的人的 RAS 計劃都需要一個組合。並且能夠移動這些程序以便您可以獲得劑量並能夠與其他藥物結合使用是很重要的。我們有我們的 RAF 抑製劑的早期數據以及我們認為需要的許多屬性。我們很高興這些卡片看起來可以對我們的 KRAS 計劃產生積極影響。但是,當我們在會議上展示數據時,我們將在適當的時間分享單藥治療和與派姆單抗聯合治療的數據。
Robert M. Davis - President, CEO & Director
Robert M. Davis - President, CEO & Director
And Umer, to the specific question of the conversion, it's probably too early to get into the specifics of that. But I would say, generally, we do see this as bringing meaningful patient benefit. If you think about quality of life, as you move especially into earlier stages of cancer, to be able to deliver the drug subcutaneously, we think is both innovative and will bring real value to the patients. So that is part of the strategy as we look at the totality of how is it that we continue to deliver for patients as we extend our franchise. So that's something we're looking at, but more details as we get further down the road.
Umer,對於轉換的具體問題,現在討論具體問題可能還為時過早。但我想說,總的來說,我們確實認為這會帶來有意義的患者利益。如果您考慮生活質量,尤其是進入癌症早期階段,以便能夠皮下給藥,我們認為這既具有創新性,也將為患者帶來真正的價值。因此,這是戰略的一部分,因為我們會在擴展特許經營權的過程中全面了解我們如何繼續為患者提供服務。這就是我們正在研究的東西,但隨著我們走得更遠,更多細節。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thank you, Umer. Next question, please, Lia.
謝謝你,烏默爾。下一個問題,Lia。
Operator
Operator
Next is Mohit Bansal with Wells Fargo.
接下來是富國銀行的 Mohit Bansal。
Mohit Bansal - Senior Equity Analyst
Mohit Bansal - Senior Equity Analyst
And staying on sotatercept, especially with the CADENCE study. So we spoke to a doctor and he was very excited about the study given that there are no approved therapies in the subset of patients you are going after. Could you help us frame expectations for this study? Because a lot of these endpoints are very similar to STELLAR. So would you expect a similar level of efficacy or bar could be lower given there's no standard of care there?
並堅持使用 sotatercept,尤其是在 CADENCE 研究中。因此,我們與一位醫生進行了交談,他對這項研究感到非常興奮,因為在您要治療的那部分患者中沒有獲得批准的治療方法。你能幫助我們制定對這項研究的期望嗎?因為很多這些端點與 STELLAR 非常相似。那麼,鑑於那裡沒有護理標準,您是否會期望類似水平的功效或酒吧可能會更低?
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Yes. So let me just speak to, we look at both our both sotatercept, and I would just also emphasize our inhaled soluble guanylate cyclase as the same sort of general sense, which is we're willing to drive it into PAH. But when you look at the mechanism of action, you ask yourself, is there other places that you can affect diseases, that aren't pulmonary arterial hypertension, but diseases where you have pulmonary hypertension, such as diastolic heart failure or, for example, in lung disease.
是的。所以讓我談談,我們看看我們的兩個 sotatercept,我也只是強調我們吸入的可溶性鳥苷酸環化酶是同一種一般意義上的,我們願意將它驅動到 PAH 中。但是當您查看作用機制時,您會問自己,是否有其他地方可以影響疾病,不是肺動脈高壓,而是您患有肺動脈高壓的疾病,例如舒張性心力衰竭,或者,例如,在肺病中。
Our expectation is that we want to explore whether sotatercept and its unique mechanism of rebalancing certain molecular pathways could also be applied to those patients who have diastolic heart failure and pulmonary hypertension. And given the impact that sotatercept has that we've seen already with PAH, that gives us a little bit more confidence that, that mechanism may be applicable to those people with diastolic heart car failure.
我們的期望是,我們希望探索 sotatercept 及其重新平衡某些分子途徑的獨特機制是否也可以應用於患有舒張性心力衰竭和肺動脈高壓的患者。鑑於我們已經看到的對 PAH 的 sotatercept 的影響,這讓我們更有信心,這種機制可能適用於那些患有舒張性心力衰竭的人。
Equivalent is, as we moved our in-house inhaled soluble guanylate cyclase -- in PAH, we're also evaluating whether that molecule could also be used in those patients with lung disease who have pulmonary hypertension. So the results give us more confidence at the next step.
等效的是,當我們移動內部吸入的可溶性鳥苷酸環化酶時——在 PAH 中,我們也在評估該分子是否也可用於患有肺動脈高壓的肺病患者。所以結果讓我們對下一步更有信心。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Great. Thank you, Mohit. Next question, please, Lia.
偉大的。謝謝你,莫希特。下一個問題,Lia。
Operator
Operator
Next question, Chris Shibutani with Goldman Sachs.
下一個問題,高盛的 Chris Shibutani。
Chris Shibutani - Research Analyst
Chris Shibutani - Research Analyst
To follow on Steve's question, to Rob in terms of the response about what you're most proud about. You talked about the successful implications of spinning off the Organon business and having an organization have a little bit of a simpler structure and focus. I want to juxtapose the question of the Animal Health business. Talk a little bit about your views these days in terms of how that fits the capital allocation priorities, whether you envision potential for that to be a strategic step that you would consider to perhaps separate that business.
繼續史蒂夫的問題,就你最引以為豪的事情向 Rob 提問。您談到了剝離 Organon 業務並讓組織具有更簡單的結構和重點的成功意義。我想把動物保健業務的問題並列起來。這些天來談談你的觀點,看看這如何符合資本分配的優先事項,你是否認為這可能是一個戰略步驟,你可能會考慮將該業務分開。
Robert M. Davis - President, CEO & Director
Robert M. Davis - President, CEO & Director
Sure, Chris, thanks for the question. As we've said in the past, we are always looking at the portfolio. We were always asking what is the best structure to develop and generate long-term value for our business and for our shareholders.
當然,克里斯,謝謝你的問題。正如我們過去所說,我們一直在關注投資組合。我們一直在問,為我們的業務和股東開發和創造長期價值的最佳結構是什麼。
And with that view, we continue to believe that the Animal Health business is a key growth driver for us. It brings a lot of synergies, frankly, in both directions. Obviously, they are benefiting from their ability to access the science on the human health side. We're benefiting from the value they bring and, in some cases, frankly, on the vaccine side, some of the manufacturing technologies are actually being brought over into the human health side.
基於這種觀點,我們仍然相信動物保健業務是我們的主要增長動力。坦率地說,它在兩個方向都帶來了很多協同作用。顯然,他們受益於他們在人類健康方面獲取科學的能力。我們從它們帶來的價值中受益,坦率地說,在某些情況下,在疫苗方面,一些製造技術實際上正在被帶到人類健康方面。
So we do see synergies in these 2 businesses. We continue to believe that our ability to invest fully to optimize the opportunity in Animal Health is there. I think we've demonstrated that through the capital we've deployed and that capital is paying off. And I don't believe that business would have the capital it's had to grow if it wasn't part of Merck. So it's benefiting from what we can bring to them. We're benefiting from what it brings to us and as of now, we continue to see it as a strategic asset. So no plans to look at spinning it.
因此,我們確實看到了這兩項業務的協同效應。我們仍然相信,我們有能力充分投資以優化動物保健領域的機會。我認為我們已經通過我們部署的資本證明了這一點,而且這些資本正在得到回報。如果不是默克的一部分,我不相信企業將擁有必須增長的資本。所以它受益於我們可以帶給他們的東西。我們從它給我們帶來的東西中受益,截至目前,我們繼續將其視為一項戰略資產。所以沒有打算看旋轉它。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Thanks, Chris. Next question, please.
謝謝,克里斯。下一個問題,請。
Operator
Operator
Our next question is from Luisa Hector with Berenberg.
我們的下一個問題來自 Luisa Hector 和 Berenberg。
Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team
Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team
Maybe a little bit more on islatravir, given your confidence to continue development. Can you say any more about the impact the drug is having on lymphocytes at the lower dose? Clearly, you're able to move forward until the regulator is happy. Is there some level of lymphocyte reduction that the regulator will accept? And how should we think about the risk of resistance development with the low dose? And when might we see some Phase III data?
考慮到您對繼續開發的信心,可能會更多地了解 islatravir。您能再說說藥物在較低劑量下對淋巴細胞的影響嗎?顯然,您可以繼續前進,直到監管機構滿意為止。調節器是否會接受某種程度的淋巴細胞減少?我們應該如何考慮低劑量產生耐藥性的風險?我們什麼時候可以看到一些 III 期數據?
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Thank you very much of that question. So I just want to emphasize that islatravir is one molecule in our suite of NRTTI molecule. And as you mentioned, we are very interested in the importance of this body of molecules and mechanism, both for the prep setting and for the treatment setting. And it has the possibility of really transforming the longer-acting space.
非常感謝你的這個問題。所以我只想強調,islatravir 是我們 NRTTI 分子套件中的一個分子。正如你所提到的,我們對這種分子和機制的重要性非常感興趣,無論是對於準備設置還是治療設置。它有可能真正改變長效空間。
Specifically to your question, we have a large range of clinical data as...
具體到您的問題,我們有大量的臨床數據...
Operator
Operator
We're sorry, your conference will end in 1 minute.
很抱歉,您的會議將在 1 分鐘後結束。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Excuse me, our conference will continue past 9 a.m.
對不起,我們的會議將持續到上午 9 點。
Operator
Operator
We are attempting to make sure that happens, sir.
先生,我們正在努力確保這種情況發生。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Okay. Thank you. We're prepared to go a few extra minutes.
好的。謝謝你。我們準備多花幾分鐘。
Dean Y. Li - Executive VP & President of Merck Research Laboratories
Dean Y. Li - Executive VP & President of Merck Research Laboratories
And so we have a plethora of clinical data. We are very confident that the 0.25 milligrams will be effective. We are confident that the effects on lymphocytes and CD4 T-cells will be comparable to any standard antiviral. And so that's in the Q day. We're also very interested in moving to the Q week with our partner, Gilead. And hopefully, that will begin to get posted more, but we're focusing on amending the protocol and the dosing regimen under the guidance of the FDA.
所以我們有大量的臨床數據。我們非常有信心 0.25 毫克會有效。我們相信,對淋巴細胞和 CD4 T 細胞的影響將與任何標準抗病毒藥物相媲美。這就是 Q 日。我們也非常有興趣與我們的合作夥伴 Gilead 一起進入 Q 週。希望這將開始更多地發布,但我們專注於在 FDA 的指導下修改協議和給藥方案。
And I also want to emphasize that we'll continue to be committed on the 2-month oral. I mean just think, 12 pills a year, 12 pills a year for patients who are at high risk to take for prep. We have MK-8527, it is a different molecule in our suite of NRTTIs and we're confident that...
我還想強調,我們將繼續致力於為期 2 個月的口頭會議。我的意思是想一想,每年 12 粒藥片,12 粒藥片供高危患者服用。我們有 MK-8527,它是我們 NRTTI 套件中的一種不同分子,我們相信……
Operator
Operator
We're sorry, your conference is ending now. Please hang up.
很抱歉,您的會議現在結束。請掛斷電話。
Peter Dannenbaum - VP of IR
Peter Dannenbaum - VP of IR
Okay. So we're back. Sorry about that. The call seems to have been cut off. But for those that are still listening, we will take 2 more questions. Lia, can you queue up the next question, please?
好的。所以我們回來了。對於那個很抱歉。電話好像被掛斷了。但對於那些仍在聽的人,我們將再回答 2 個問題。莉亞,你可以排隊下一個問題嗎?
So apologies for the technical difficulties. Lia, can you hear us? Okay. So for those that are still on the line, thank you very much. We'll have to close the call there because of those technical difficulties. For those that were in the queue, please follow up with IR and we'll hope to get your questions answered. Thank you all very much.
所以對技術上的困難表示歉意。利亞,你能聽到我們的聲音嗎?好的。所以對於那些仍然在線的人,非常感謝你們。由於這些技術困難,我們將不得不在那裡結束通話。對於那些在隊列中的人,請跟進 IR,我們希望能回答您的問題。非常感謝大家。