美國安進 (AMGN) 2021 Q3 法說會逐字稿

My name is Erica, and I will be your conference facilitator today for Amgen's Third Quarter 2021 Financial Results Conference Call.

我叫 Erica，今天我將擔任安進公司 2021 年第三季度財務業績電話會議的會議主持人。

(Operator Instructions) I would now like to introduce Arvind Sood, Vice President of Investor Relations.

（操作員說明）我現在想介紹投資者關係副總裁 Arvind Sood。

Mr. Sood, you may now begin.

蘇德先生，您現在可以開始了。

Erica, thank you.

艾麗卡，謝謝。

Good afternoon, everybody.

大家下午好。

Welcome to our Q3 call.

歡迎來到我們的第三季度電話會議。

I think the 3 key themes for this quarter are continued execution, pipeline advancement and preparedness to launch important new products.

我認為本季度的 3 個關鍵主題是持續執行、管道推進和準備推出重要的新產品。

So let's get started.

所以讓我們開始吧。

The slides have been posted.

幻燈片已發布。

A quick reminder that we'll use non-GAAP financial measures in our presentation, and some of the statements will be forward-looking statements.

快速提醒一下，我們將在演示文稿中使用非公認會計原則財務指標，其中一些陳述將是前瞻性陳述。

Our SEC filings identify factors that could cause our actual results to differ materially.

我們向美國證券交易委員會提交的文件確定了可能導致我們的實際結果出現重大差異的因素。

So with that, I would like to turn the call over to our Chairman and CEO, Bob Bradway, Bob?

因此，我想將電話轉給我們的董事長兼首席執行官 Bob Bradway，Bob？

Okay.

好的。

Hello, everyone, and thank you for joining our call.

大家好，感謝您加入我們的電話。

It was another solid quarter of growth for Amgen with total revenues rising 4%, driven by volume growth of 8% which reflects the strong global demand for many of our innovative medicines such as Repatha and Prolia as well as for our high-quality biosimilars.

這是安進（Amgen）又一個穩健增長的季度，總收入增長 4%，受銷量增長 8% 的推動，這反映了全球對我們的許多創新藥物（如 Repatha 和 Prolia）以及我們的高質量生物仿製藥的強勁需求。

Earnings per share for the quarter grew 11%, thanks to disciplined management of our operating expenses.

由於我們對運營費用的嚴格管理，本季度的每股收益增長了 11%。

Shifting to the future.

轉向未來。

As we begin to see beyond COVID-19, I believe we've set ourselves up well to deliver attractive growth over the long term.

隨著我們開始看到 COVID-19 之後的情況，我相信我們已經做好了準備，可以在長期內實現有吸引力的增長。

By way of example, I'll draw your attention to our immunology and oncology portfolios where we are building on our successful track record through a combination of internally generated innovation and strategic business development, which we expect to contribute to our long-term growth.

舉例來說，我將提請您注意我們的免疫學和腫瘤學產品組合，我們通過內部產生的創新和戰略業務發展相結合，建立了我們成功的業績記錄，我們預計這將為我們的長期增長做出貢獻。

In inflammation, we're very excited about tezepelumab, a first-in-class treatment for severe asthma that we hope to launch in the U.S. next year.

在炎症方面，我們對 tezepelumab 感到非常興奮，這是一種一流的治療嚴重哮喘的藥物，我們希望明年在美國推出。

Given the millions of patients for whom existing asthma therapies are inadequate, we believe tezepelumab will be a significant growth driver for us for years to come.

鑑於現有哮喘療法不足以滿足數百萬患者的需求，我們相信 tezepelumab 將成為我們未來幾年的重要增長動力。

This product builds on our many years of success in inflammation, first with Enbrel and now, of course, with Otezla.

該產品建立在我們多年在炎症方面的成功基礎之上，首先是 Enbrel，現在當然是 Otezla。

We remain optimistic about the growth potential of Otezla.

我們對 Otezla 的增長潛力保持樂觀。

And as the next step, we're eagerly awaiting an expanded indication in the U.S. for mild-to-moderate plaque psoriasis, particularly at a time when concerns have emerged for some potential new competitors.

作為下一步，我們急切地等待在美國擴大對輕度至中度斑塊狀銀屑病的適應症，特別是在一些潛在的新競爭對手出現擔憂的時候。

We also continue to grow Otezla globally with the product now available in over 40 countries, up from 32 countries when we acquired it.

我們還繼續在全球範圍內發展 Otezla，該產品現已在 40 多個國家/地區提供，而我們收購它時為 32 個國家/地區。

Looking a bit further into the future, we expect to bring AMGEVITA, our biosimilar to HUMIRA to the U.S. in 2023.

展望未來，我們希望在 2023 年將我們的 HUMIRA 生物仿製藥 AMGEVITA 帶到美國。

We expect to replicate the success we've had with AMGEVITA in many other markets around the world.

我們希望在全球許多其他市場複製我們在 AMGEVITA 方面取得的成功。

We're also enthusiastic about AMG 451, a Phase III-ready potential first-in-class treatment for atopic dermatitis that we're studying with our partners, Kyowa Kirin, as well as a number of Amgen-discovered therapies currently in Phase II for lupus and celiac disease.

我們也對 AMG 451 充滿熱情，這是一種針對特應性皮炎的 III 期潛在一流治療藥物，我們正在與我們的合作夥伴 Kyowa Kirin 以及目前處於 II 期的許多安進發現的療法進行研究用於狼瘡和乳糜瀉。

In oncology, we're happy with the recent launch in the U.S. of LUMAKRAS our first-in-class KRAS G12C inhibitor, which treats non-small cell lung cancer and we look forward to additional approvals and launches in major markets around the world as we roll forward.

在腫瘤學方面，我們很高興最近在美國推出了我們的一流 KRAS G12C 抑製劑 LUMAKRAS，該抑製劑可治療非小細胞肺癌，我們期待在全球主要市場獲得更多批准和推出我們向前滾動。

LUMAKRAS joins a portfolio of medicines already generating some $10 billion a year in sales.

LUMAKRAS 加入了已產生每年約 100 億美元銷售額的藥物組合。

Several of these medicines delivered double-digit sales growth in the third quarter, including KYPROLIS, BLINCYTO and MVASI.

其中幾種藥物在第三季度實現了兩位數的銷售增長，包括 KYPROLIS 、 BLINCYTO 和 MVASI 。

Looking ahead, we're excited about the growth potential of several other oncology assets in our pipeline.

展望未來，我們對我們管道中其他幾個腫瘤學資產的增長潛力感到興奮。

We've initiated already our first Phase III trial for bemarituzumab, a potential first-in-class molecule to treat gastric and gastroesophageal junction cancers.

我們已經啟動了第一個 bemarituzumab 的 III 期試驗，bemarituzumab 是一種治療胃癌和胃食管結合部癌的潛在一流分子。

We're also making good progress with several of our internally discovered solid BiTE -- solid tumor BiTE molecules, including 1 for prostate cancer and another for small cell lung cancer.

我們在內部發現的幾種固體 BiTE（實體瘤 BiTE 分子）方面也取得了良好進展，其中一種用於前列腺癌，另一種用於小細胞肺癌。

In short, we have a number of products now on the market with plenty of room to grow, more coming over the next several years from our pipeline, a compelling discovery research engine to continuously replenish that pipeline and the wherewithal to take advantage of compelling business development opportunities as they arise.

簡而言之，我們現在在市場上有許多產品有很大的增長空間，未來幾年還會有更多來自我們的管道，一個引人注目的發現研究引擎，不斷補充該管道，以及利用引人注目的業務的資金出現的發展機會。

All that gives me confidence in our ability to serve more patients around the world and to deliver strong financial performance for our shareholders.

所有這一切讓我對我們有能力為世界各地的更多患者提供服務並為我們的股東帶來強勁的財務業績充滿信心。

One final note, I'd like to thank my Amgen colleagues for their continued commitment to patients and to our business.

最後一點，我要感謝我的安進同事，感謝他們對患者和我們業務的持續承諾。

We were delighted to be named last week by Fortune Magazine as one of the 25 best workplaces in the world and that's a reflection of our people and the passion and excellence they bring to their work.

我們很高興上週被《財富》雜誌評為全球 25 個最佳工作場所之一，這反映了我們的員工以及他們為工作帶來的熱情和卓越。

Dave, let me turn it over to you.

戴夫，讓我把它交給你。

Thanks, Bob, and good afternoon, everyone.

謝謝，鮑勃，大家下午好。

I would like to begin by welcoming our new colleagues from Teneobio, who bring expertise and technologies that will accelerate our innovation.

首先，我想歡迎來自 Teneobio 的新同事，他們帶來的專業知識和技術將加速我們的創新。

One of our core areas of interest in research and molecular engineering is the development of multi-specific drugs to make undruggable targets tractable.

我們對研究和分子工程感興趣的核心領域之一是開發多特異性藥物以使不可成藥的靶點易於處理。

The Teneobio acquisition, combined with our previous incorporation of Nuevolution and its DNA encoded library technology provides capabilities to develop both large and small molecule multi-specifics and is a good example of how we are combining internal and external sources of innovation to advance the R&D portfolio.

Teneobio 的收購，結合我們之前對 Nuevolution 及其 DNA 編碼庫技術的整合，提供了開發大分子和小分子多特異性的能力，是我們如何結合內部和外部創新資源來推進研發組合的一個很好的例子.

More than 60% of the molecules in our preclinical pipeline are multi-specifics.

我們臨床前管道中超過 60% 的分子是多特異性的。

We will have more to say as those programs advance.

隨著這些項目的推進，我們將有更多話要說。

Across R&D, we have focused on building a portfolio of complementary assets in certain disease areas to help drive the long-term growth of the company.

在研發方面，我們專注於在某些疾病領域建立互補資產組合，以幫助推動公司的長期增長。

Turning to our clinical programs, I'll highlight a few areas where we have made significant progress and are advancing multiple first-in-class molecules.

談到我們的臨床項目，我將重點介紹我們取得重大進展並正在推進多個一流分子的幾個領域。

In oncology, one key area of focus is lung cancer.

在腫瘤學中，重點關注的一個領域是肺癌。

As you'll hear from Murdo, the LUMAKRAS launch is off to an excellent start, and the clinical programs remain on track.

正如您從 Murdo 那裡聽到的那樣，LUMAKRAS 的推出有了一個良好的開端，臨床項目仍在進行中。

We have initiated the Phase II study of LUMAKRAS monotherapy in first-line non-small cell lung cancer for patients with STK11 mutant and/or PD-L1 negative tumors.

我們已經啟動了針對 STK11 突變和/或 PD-L1 陰性腫瘤患者的 LUMAKRAS 單藥治療一線非小細胞肺癌的 II 期研究。

We continue to expect the top line results from the Phase III confirmatory study versus docetaxel as well as data from our PD-1 combination and SHP combination cohorts in the first half of next year.

我們繼續期待 III 期驗證性研究與多西他賽的一線結果以及明年上半年我們的 PD-1 組合和 SHP 組合隊列的數據。

In the tarlatamab or AMG 757 BiTE program targeting DLL3 in small cell lung cancer, some patients with very advanced disease in the Phase I trial have now had responses lasting over a year, supporting our potentially registrational Phase II study, which we intend to launch by year-end.

在針對小細胞肺癌中 DLL3 的 tarlatamab 或 AMG 757 BiTE 計劃中，在 I 期試驗中一些患有非常晚期疾病的患者現在已經有持續一年以上的反應，這支持了我們潛在的註冊 II 期研究，我們打算通過年末。

Finally, in squamous non-small cell lung cancer, we will initiate a Phase Ib study of bemarituzumab directed against FGFR2b in the coming months.

最後，在鱗狀非小細胞肺癌中，我們將在未來幾個月啟動針對 FGFR2b 的 bemarituzumab 的 Ib 期研究。

Turning to gastrointestinal cancers.

轉向胃腸癌。

We will begin enrolling a Phase III trial of LUMAKRAS in combination with Vectibix in third-line colorectal cancer in the coming weeks.

我們將在未來幾週開始招募 LUMAKRAS 與 Vectibix 聯合用於三線結直腸癌的 III 期試驗。

In first-line gastric cancer, we have initiated the first of multiple Phase III studies with bemarituzumab with additional trial starts in the coming months.

在一線胃癌中，我們已經啟動了貝馬妥珠單抗多項 III 期研究中的第一項，並在未來幾個月開始進行更多試驗。

These studies will address regional differences in the treatment of gastric cancer by exploring bemarituzumab in combination with either backbone chemotherapy or chemotherapy plus a checkpoint inhibitor.

這些研究將通過探索 bemarituzumab 聯合骨乾化療或化療加檢查點抑製劑來解決胃癌治療的區域差異。

Prostate cancer is another area of focus in oncology.

前列腺癌是腫瘤學的另一個重點領域。

With the acquisition of Teneobio, we now have 2 distinct bi-specific T cell engager technologies targeting PSMA.

通過收購 Teneobio，我們現在擁有兩種針對 PSMA 的不同雙特異性 T 細胞接合技術。

We anticipate decision enabling data from the expansion cohort in the acapatamab, AMG 160 program, in the first half of next year and are now exploring outpatient administration.

我們預計明年上半年來自 acapatamab 、 AMG 160 計劃的擴展隊列的決策支持數據，現在正在探索門診管理。

AMG 340, formerly TNB-585 continues to progress through dose escalation, and we anticipate having informative data by the middle of next year as well, allowing us to determine the best path forward for one or both of these PSMA molecules.

AMG 340，以前的 TNB-585 繼續通過劑量升級取得進展，我們預計到明年年中也將獲得信息數據，使我們能夠確定這些 PSMA 分子中的一個或兩個的最佳前進路徑。

Finally, rounding out our prostate cancer portfolio is AMG 509, targeting STEAP1, which is also progressing through dose escalation.

最後，完善我們的前列腺癌產品組合的是 AMG 509，針對 STEAP1，它也在通過劑量遞增進行。

We anticipate having decision-making data next year.

我們預計明年會有決策數據。

In inflammation, we spoke at length a few weeks ago about the increasing activity in our portfolio of both innovative and biosimilar molecules, regulatory approvals and launches expected in each of the next several years.

在炎症方面，我們幾週前詳細談到了我們的創新和生物仿製藥分子組合的活動日益增加，監管批准和預計在未來幾年的每一年推出。

In the tezepelumab program, regulatory reviews in severe asthma are proceeding with an FDA action date in the first quarter of 2022.

在 tezepelumab 項目中，嚴重哮喘的監管審查正在進行中，FDA 的行動日期為 2022 年第一季度。

Studies in 3 additional indications are in progress to investigate the utility of tezepelumab across a range of inflammatory diseases.

正在對另外 3 個適應症進行研究，以研究 tezepelumab 在一系列炎性疾病中的效用。

In skin autoimmune diseases, the FDA review of Otezla for mild-to-moderate psoriasis continues with a PDUFA date in December.

在皮膚自身免疫性疾病中， FDA 對 Otezla 對輕度至中度銀屑病的審查繼續進行，PDUFA 日期在 12 月。

A few weeks ago, we presented results from a Phase II study of AMG 451, KHK4083, a first-in-class dual action anti-OX40 antibody we are developing for atopic dermatitis in collaboration with Kyowa Kirin.

幾週前，我們展示了 AMG 451、KHK4083 的 II 期研究結果，這是一種一流的雙重作用抗 OX40 抗體，我們正在與 Kyowa Kirin 合作開髮用於治療特應性皮炎。

These data were very well received by the medical community as there is a clear need for innovative therapies with differentiated mechanisms of action for these patients.

這些數據得到了醫學界的好評，因為這些患者顯然需要具有不同作用機制的創新療法。

We have had productive regulatory interactions on the program and plan to launch Phase III trials in the first half of 2022.

我們對該項目進行了富有成效的監管互動，併計劃在 2022 年上半年啟動 III 期試驗。

Finally, we also expect Phase III data from biosimilar candidates to STELARA, EYLEA and SOLIRIS in the inflammation portfolio next year.

最後，我們還預計明年炎症組合中 STELARA 、 EYLEA 和 SOLIRIS 的生物仿製藥候選者的 III 期數據。

In cardiometabolic disease, in atherosclerosis, the Repatha of the VESALIUS trial, Phase III outcome study of approximately 12,000 patients at high cardiovascular risk, but without prior myocardial infarction or stroke is expected to complete enrollment in the coming weeks.

在心臟代謝疾病、動脈粥樣硬化、VESALIUS 試驗的 Repatha 中，大約 12,000 名心血管高危患者的 III 期結果研究預計將在未來幾週內完成入組。

Olpasiran, a small interfering RNA targeting Lp(a) and our first RNA-based therapy remains on track to read out Phase IIb data by the middle of 2022 and provides a potential complement to Repatha in the treatment of atherosclerotic cardiovascular disease, by serving patients whose pathology is not driven by LDL-cholesterol.

Olpasiran 是一種靶向 Lp(a) 的小干擾 RNA，我們的第一個基於 RNA 的療法仍有望在 2022 年中期讀出 IIb 期數據，並通過為患者提供服務，為 Repatha 在動脈粥樣硬化性心血管疾病的治療中提供潛在的補充其病理學不是由低密度脂蛋白膽固醇驅動的。

In conclusion, with an innovative portfolio where approximately 3/4 of our clinical stage programs have first-in-class potential and a growing portfolio of biosimilars, we are well positioned to continue to deliver important new medicines for patients and growth for shareholders over the near and long term.

總之，憑藉我們大約 3/4 的臨床階段項目具有一流潛力的創新產品組合和不斷增長的生物仿製藥產品組合，我們有能力繼續為患者提供重要的新藥並為股東提供增長近期和長期。

Murdo?

默多？

Thank you, Dave.

謝謝你，戴夫。

Third quarter product sales increased 4% year-over-year.

第三季度產品銷售額同比增長 4%。

Volumes increased 8% globally, and we had record quarterly sales for several of our key products, including EVENITY, KYPROLIS, XGEVA and Nplate.

全球銷量增長了 8%，我們的幾個關鍵產品的季度銷售額創下歷史新高，包括 EVENITY、KYPROLIS、XGEVA 和 Nplate。

Our ex U.S. business grew 19% with volume growth of 25% year-over-year.

我們的前美國業務增長 19%，銷量同比增長 25%。

We continue to execute our volume-driven growth strategy and see gradual recovery in our business from the impact of the pandemic.

我們繼續執行以銷量為導向的增長戰略，並看到我們的業務從大流行的影響中逐漸復蘇。

During the early part of Q3, we saw volatility in patient care dynamics due to a surge in COVID-19.

在第三季度初期，由於 COVID-19 激增，我們看到了患者護理動態的波動。

As we progressed through the quarter, we saw improvement in patient visits and diagnoses.

隨著本季度的進展，我們看到患者就診和診斷有所改善。

Total customer activity improved during Q3.

第三季度的總客戶活動有所改善。

However, face-to-face customer interactions remain below 2019 levels.

然而，面對面的客戶互動仍低於 2019 年的水平。

Now let me review some product details, beginning with our general medicine portfolio, which includes Prolia, EVENITY, Repatha, and Aimovig.

現在讓我回顧一些產品細節，從我們的普通藥物組合開始，包括 Prolia、EVENITY、Repatha 和 Aimovig。

Overall revenue for our general medicine portfolio grew 22% year-over-year with 24% volume growth.

我們的普通醫藥產品組合的總收入同比增長 22%，銷量增長 24%。

In bone health, Prolia sales grew 15% year-over-year, driven by double-digit volume growth.

在骨骼健康方面，Prolia 銷售額同比增長 15%，這得益於兩位數的銷量增長。

In the third quarter, new and repeat patient demand continued to improve as osteoporosis diagnosis rates reached over 90% of pre-COVID levels.

在第三季度，隨著骨質疏鬆症診斷率達到新冠病毒前水平的 90% 以上，新患者和重複患者的需求繼續改善。

EVENITY, which complements Prolia in our bone portfolio, had record sales of $149 million for the third quarter, driven by strong volume growth.

EVENITY 在我們的骨骼產品組合中補充了 Prolia，在強勁的銷量增長的推動下，第三季度的銷售額達到了創紀錄的 1.49 億美元。

Given the severe impact of fractures on the lives of postmenopausal women, EVENITY provides an excellent therapy to build bone first.

鑑於骨折對絕經後婦女生活的嚴重影響，EVENITY 提供了一種極好的治療方法來首先建立骨骼。

Moving to Repatha, which remains the global leader in the PCSK9 class.

轉移到 Repatha，它仍然是 PCSK9 類的全球領導者。

Repatha sales increased 33% year-over-year, driven by 42% volume growth.

在銷量增長 42% 的推動下，Repatha 的銷售額同比增長 33%。

In the U.S., we saw 64% year-over-year volume growth.

在美國，我們看到了 64% 的同比銷量增長。

This was partially offset by lower net selling price stemming from an increase in the number of Medicare Part D patients receiving Repatha and who entered the doughnut hole.

由於接受 Repatha 並進入甜甜圈洞的 Medicare Part D 患者人數增加，淨售價下降部分抵消了這一影響。

Outside the U.S., volumes grew 24% year-over-year.

在美國以外，銷量同比增長 24%。

We remain confident in our ability to grow Repatha globally to address the significant unmet medical need in treating high-risk cardiovascular patients.

我們仍然對我們在全球範圍內發展 Repatha 以解決治療高危心血管患者的重大未滿足醫療需求的能力充滿信心。

Moving to our inflammation portfolio, Otezla sales increased 13% year-over-year with 7% volume growth.

轉向我們的炎症產品組合，Otezla 的銷售額同比增長 13%，銷量增長 7%。

Since its launch, Otezla has been used by over 750,000 patients globally.

自推出以來，Otezla 已被全球超過 750,000 名患者使用。

And in the U.S., it is the leader in bio-naive psoriasis patient share.

在美國，它是生物銀屑病患者份額的領導者。

Otezla has 92% commercial payer coverage and is an affordable, safe and efficacious option for psoriasis and psoriatic arthritis patients.

Otezla 擁有 92% 的商業付款人覆蓋率，是銀屑病和銀屑病關節炎患者負擔得起、安全且有效的選擇。

We are now preparing for the anticipated U.S. approval of the mild-to-moderate psoriasis indication in the fourth quarter when we will have the opportunity for the first time to promote the use of Otezla in this patient population.

我們現在正在為預期的美國在第四季度批准輕度至中度銀屑病適應症做準備，屆時我們將有機會首次在該患者群體中推廣 Otezla 的使用。

Enbrel sales decreased 3% year-over-year, driven by a 2% decline in volume.

由於銷量下降 2%，Enbrel 銷售額同比下降 3%。

This is the second straight quarter of slowing volume declines, thanks to Enbrel's long track record of efficacy and safety.

這是連續第二個季度銷量下降放緩，這要歸功於 Enbrel 在療效和安全性方面的長期記錄。

Together with our partner, AstraZeneca, we're preparing for the launch of tezepelumab in the U.S. with an expected PDUFA date in early Q1 2022.

與我們的合作夥伴阿斯利康（AstraZeneca）一起，我們正準備在美國推出 tezepelumab，預計 PDUFA 日期為 2022 年第一季度初。

Our sales force is fully staffed, trained and has been deployed to provide disease state education.

我們的銷售人員配備齊全、訓練有素，並已部署到提供疾病狀態教育。

We are actively engaging with payers to ensure access to patients for this breakthrough medicine.

我們正在積極與付款人合作，以確保患者能夠獲得這種突破性藥物。

We look forward to bringing tezepelumab to the 2.5 million people around the world who live with severe uncontrolled asthma.

我們期待將 tezepelumab 帶給全世界 250 萬患有嚴重無法控制的哮喘的人。

Moving to the hematology and oncology business.

轉向血液學和腫瘤學業務。

Sales of our 6 innovative products and our MVASI and KANJINTI biosimilars collectively totaled $1.8 billion in the quarter, growing 12% year-over-year.

本季度，我們的 6 種創新產品以及 MVASI 和 KANJINTI 生物仿製藥的銷售額合計為 18 億美元，同比增長 12%。

Several brands had record sales in the quarter, including XGEVA, KYPROLIS, Nplate, and BLINCYTO.

幾個品牌在本季度的銷售額創歷史新高，包括 XGEVA、KYPROLIS、Nplate 和 BLINCYTO。

Neulasta Onpro maintained 50% volume share in the quarter and continues to be the preferred choice for physicians and patients.

Neulasta Onpro 在本季度保持 50% 的銷量份額，並繼續成為醫生和患者的首選。

The most recent published average selling price for Neulasta in the U.S. declined 38% year-over-year and 10% quarter-over-quarter.

Neulasta 最近公佈的美國平均售價同比下降 38%，環比下降 10%。

Going forward, we expect increased competition to result in continued net price and volume erosion.

展望未來，我們預計競爭加劇將導致淨價格和銷量持續下降。

Our launch of LUMAKRAS is off to a strong start with revenues of $36 million in Q3 and cumulative sales of $45 million through the end of the third quarter.

我們推出的 LUMAKRAS 開局良好，第三季度收入為 3600 萬美元，截至第三季度末的累計銷售額為 4500 萬美元。

LUMAKRAS has been prescribed by over 500 oncologists in both academic and community settings.

LUMAKRAS 已被學術和社區環境中的 500 多名腫瘤學家開處方。

A majority of clinical laboratories have updated their testing reports to reflect KRAS G12C as an actionable mutation and approximately 75% of patients with non-small cell lung cancer are now being tested for the mutation at the time of diagnosis.

大多數臨床實驗室已經更新了他們的檢測報告，將 KRAS G12C 反映為一種可操作的突變，現在大約 75% 的非小細胞肺癌患者在診斷時正在接受突變檢測。

Having been a part of several lung cancer launches in my career, I'm very pleased with the LUMAKRAS launch uptake in the U.S. Thanks to our broad payer access and the positive reaction from the oncology community.

在我的職業生涯中，我曾參與過幾次肺癌的發布，我對 LUMAKRAS 在美國的發布感到非常高興。這要歸功於我們廣泛的支付渠道和腫瘤學界的積極反應。

Outside the U.S., health authorities have also approved LUMAKRAS in Canada and LUMAKRAS in the U.K.

在美國以外，衛生當局還批准了加拿大的 LUMAKRAS 和英國的 LUMAKRAS。

Overall, I'm pleased with our results for the quarter, our record sales across a number of products and our increasing levels of customer activity.

總體而言，我對本季度的業績、多種產品的創紀錄銷售額以及不斷提高的客戶活動水平感到滿意。

And with that, I'll turn it to Peter.

有了這個，我會把它交給彼得。

Thank you, Murdo.

謝謝你，默多。

I will briefly walk through our third quarter financial results before discussing 2021 guidance.

在討論 2021 年指引之前，我將簡要介紹我們的第三季度財務業績。

Our team's quality of execution during the past 18 challenging months continues to provide us with the strength to make timely prudent investments as we see them in both internal and external innovation that will deliver long-term growth.

在過去 18 個充滿挑戰的月份中，我們團隊的執行質量繼續為我們提供及時審慎投資的力量，因為我們看到它們在內部和外部創新方面將帶來長期增長。

Let's now turn to the business.

現在讓我們轉向業務。

The third quarter marked another period of solid performance with year-over-year revenue growth of 4% and non-GAAP EPS growth of 11%.

第三季度是另一個業績穩健的時期，收入同比增長 4%，非公認會計準則每股收益增長 11%。

As Murdo described, strong volume growth continued in the quarter with 8% year-over-year growth driven by Prolia, EVENITY, Repatha and MVASI.

正如 Murdo 所描述的，在 Prolia、EVENITY、Repatha 和 MVASI 的推動下，本季度銷量繼續強勁增長，同比增長 8%。

In addition, this quarter includes $147 million of favorable changes to estimated sales deductions previously recorded.

此外，本季度包括對先前記錄的估計銷售扣除額的 1.47 億美元有利變化。

In the third quarter last year, the favorable estimated sales deductions were $36 million, resulting in a $111 million year-over-year benefit in this quarter.

去年第三季度，有利的估計銷售扣除額為 3600 萬美元，本季度同比收益為 1.11 億美元。

Our established products, which include Neulasta, NEUPOGEN, EPOGEN, Aranesp, Parsabiv and Sensipar declined 21% year-over-year, driven by volume declines and lower net selling price.

由於銷量下降和淨售價下降，我們的成熟產品（包括 Neulasta、NEUPOGEN、EPOGEN、Aranesp、Parsabiv 和 Sensipar）同比下降 21%。

These products will continue to contribute meaningful cash flows to our broader portfolio and also to innovation.

這些產品將繼續為我們更廣泛的產品組合和創新貢獻有意義的現金流。

We do expect increased competition to result in additional erosion of these established products.

我們確實預計競爭加劇會導致這些成熟產品的進一步侵蝕。

Other revenues at $386 million increased 21% year-over-year primarily driven by shipments of the COVID-19 antibody therapy to Lilly.

其他收入為 3.86 億美元，同比增長 21%，主要是由於向禮來公司出貨 COVID-19抗體療法。

We expect full year 2021 other revenues to be in a range of $1.5 billion to $1.7 billion.

我們預計 2021 年全年其他收入將在 15 億美元至 17 億美元之間。

Third quarter total non-GAAP operating expenses were flat year-over-year as continued focus on execution, productivity and efficiency fueled investments to drive long-term growth, including the third quarter share of the approximately $200 million of operating expenses expected for the full year related to the Rodeo, Five Prime and Teneobio acquisitions as well as the Kyowa Kirin collaboration.

第三季度非 GAAP 總運營費用與去年同期持平，因為對執行、生產力和效率的持續關注推動了投資以推動長期增長，包括第三季度在預計全部運營費用中的約 2 億美元的份額與 Rodeo、Five Prime 和 Teneobio 的收購以及 Kyowa Kirin 合作相關的一年。

Through focused expense discipline, we now expect full year operating expenses on an absolute basis to increase approximately 3% to 4% over last year inclusive of the approximately $200 million related to these transactions.

通過有針對性的費用紀律，我們現在預計全年運營費用將比去年增加約 3% 至 4%，其中包括與這些交易相關的約 2 億美元。

We will continue to execute on opportunities to allocate capital to important internal and external innovation opportunities.

我們將繼續把握機會，將資金分配給重要的內部和外部創新機會。

On a non-GAAP basis, cost of sales as a percent of product sales increased 1.5 percentage points on a year-over-year basis to 15.8%, driven primarily by product mix including COVID-19 antibody shipments to Lilly.

在非公認會計原則的基礎上，銷售成本佔產品銷售額的百分比同比增長 1.5 個百分點至 15.8%，主要受產品組合的推動，包括向禮來公司出貨的 COVID-19抗體。

For the full year, we continue to expect cost of sales as a percent of product sales to be 16% to 17%.

對於全年，我們繼續預計銷售成本佔產品銷售額的百分比為 16% 至 17%。

Non-GAAP R&D spend in the quarter decreased 4% year-over-year.

本季度非 GAAP 研發支出同比下降 4%。

For the full year, we expect non-GAAP R&D spend will increase in the mid-single-digit percentage range as we progress our innovative pipeline programs, including the launch of registration-enabling trials in lung and gastric cancer.

全年，隨著我們推進創新的管道計劃，包括啟動肺癌和胃癌的註冊試驗，我們預計非 GAAP 研發支出將在中個位數百分比範圍內增加。

Non-GAAP SG&A expense in the quarter decreased 5% and we expect the full year to also decline as we continue our focus on execution efficiency and digitalization.

本季度非 GAAP SG&A 費用下降了 5%，我們預計全年也會下降，因為我們繼續關注執行效率和數字化。

Non-GAAP other income and expense net expenses increased on a year-over-year basis due to increased losses from our 20% share of BeiGene's results recorded under the equity method of accounting 1 quarter in arrears.

非 GAAP 其他收入和支出淨支出同比增加，原因是我們佔百濟神州 20% 份額的虧損增加，該份額是根據拖欠 1 個季度的權益法記錄的。

We expect full year net expense in the range of $1.3 billion to $1.4 billion.

我們預計全年淨支出在 13 億美元至 14 億美元之間。

We have financial flexibility with $12.9 billion in cash and investments on our balance sheet and strong cash flows.

我們擁有財務靈活性，資產負債表上有 129 億美元的現金和投資以及強勁的現金流。

Additionally, our third quarter dividend was $1.76 per share, an increase of 10% over last year.

此外，我們第三季度的股息為每股 1.76 美元，比去年增長 10%。

Turning to the outlook for the business for 2021.

轉向2021年的業務前景。

We have invested in internal and external innovation to advance our pipeline in 2021 and continue to set ourselves up well for long-term growth.

我們已投資於內部和外部創新，以在 2021 年推進我們的管道，並繼續為長期增長做好準備。

Moving to revenue.

轉向收入。

Based on underlying market dynamics, we are updating our 2021 revenue guidance range to $25.8 billion to $26.2 billion.

根據潛在的市場動態，我們將 2021 年的收入指導範圍更新為 258 億美元至 262 億美元。

We are increasing our non-GAAP EPS guidance range to $16.50 to $17.10.

我們正在將我們的非公認會計原則每股收益指導範圍提高到 16.50 美元至 17.10 美元。

Our non-GAAP tax rate range is updated to 13.0% to 14.0%.

我們的非公認會計原則稅率範圍更新為 13.0% 至 14.0%。

Our capital expenditure guidance remains at $900 million, and our capital expenditures continue to include investments supporting our environmental activities and also support our commitment to attain carbon neutrality.

我們的資本支出指導仍為 9 億美元，我們的資本支出繼續包括支持我們的環境活動的投資，也支持我們實現碳中和的承諾。

We expect share repurchases for 2021 to be in the upper end of our range of $3 billion to $5 billion.

我們預計 2021 年的股票回購將處於我們 30 億至 50 億美元範圍的上限。

We executed effectively in the third quarter and are well positioned for long-term growth.

我們在第三季度有效執行，並為長期增長做好了準備。

Before turning it over to Bob, I'd like to thank and recognize our 24,000 Amgen colleagues around the world for delivering another strong quarter of execution.

在將其移交給 Bob 之前，我要感謝並認可我們在世界各地的 24,000 名安進同事，他們再次提供了強勁的季度執行力。

Bob?

鮑勃？

Okay.

好的。

Thank you, Peter.

謝謝你，彼得。

Why don't we open up the call now for questions.

我們為什麼不現在打開電話詢問問題。

And let's remind our callers of the procedures and the request that we limit our questions to just one on the first go.

讓我們提醒我們的來電者有關程序和要求，我們首先將問題限制在一個問題上。

Thanks.

謝謝。

(Operator Instructions) Your first question comes from the line of Michael Yee with Jefferies.

（操作員說明）您的第一個問題來自 Jefferies 的 Michael Yee。

Just a question about the financials and how to think about go forward, that's sort of a high-level question.

只是一個關於財務狀況以及如何考慮前進的問題，這是一個高層次的問題。

But as you think about the results this year, sort of the narrowing of guidance this year, a company that typically seems to come in on the higher end, and I know there's a COVID pandemic ongoing.

但是，當您考慮今年的結果時，今年的指導範圍有所縮小，這家公司通常似乎進入了高端市場，而且我知道正在發生 COVID 大流行。

How do you think about the push and pull dynamics as we enter 2022?

當我們進入 2022 年時，您如何看待推拉動態？

I know you don't give 2022 guidance.

我知道你沒有給出 2022 年的指導。

So I would just love you to comment on the high level, realizing we're in a pandemic.

所以我希望你能對高層發表評論，意識到我們正處於大流行之中。

Yes, Michael, you're right.

是的，邁克爾，你是對的。

We're not going to give 2022 guidance at this point.

在這一點上，我們不會給出 2022 年的指導。

I think what you can see is we continue to manage the business effectively, that's, I think, reflected in the 4% on the top line, 11% on the bottom line EPS growth, and we'll continue to invest in opportunities that we think can deliver growth.

我認為您可以看到我們繼續有效地管理業務，我認為這反映在收入增長 4% 和利潤增長 11% 上，我們將繼續投資於我們的機會認為可以帶來增長。

We're very clear that as we look at the future, we expect to be able to deliver growth for our shareholders, and we'll have more to say about that when we give guidance for the next period.

我們非常清楚，當我們展望未來時，我們希望能夠為我們的股東帶來增長，當我們為下一個時期提供指導時，我們會有更多的話要說。

Your next question comes from the line of Geoff Meacham with Bank of America.

您的下一個問題來自美國銀行的 Geoff Meacham。

It's Aspen on for Geoff.

傑夫是阿斯彭。

So you previously talked about that over 3,000 patient number treated with LUMAKRAS that includes some patients on studies.

因此，您之前談到了超過 3,000 名接受 LUMAKRAS 治療的患者，其中包括一些正在研究的患者。

I guess I just want to get a sense of what percentage of that maybe the nonpaying bolus has been converted over to paying?

我想我只是想了解其中有多少百分比可能是非支付推注已轉換為支付？

And I mean what's the time line for moving through the rest of them is?

我的意思是通過其餘的時間線是什麼？

It's Murdo.

是默多。

Thanks for the question.

謝謝你的問題。

We are roughly at about 75% of early access programs or patients who were enrolled in clinical trials converting to commercial supply.

我們大約有 75% 的早期訪問計劃或參加臨床試驗的患者轉換為商業供應。

The 2 major markets where that's happening are the U.S., obviously, and in France, while, we've not been approved in Europe yet.

發生這種情況的兩個主要市場顯然是美國和法國，而我們尚未在歐洲獲得批准。

We do have access to the ATU program in France, where patients coming out of our early access program can roll into the ATU program, where we actually are booking revenue.

我們確實可以使用法國的 ATU 計劃，從我們的早期訪問計劃中出來的患者可以進入 ATU 計劃，我們實際上是在預訂收入。

Your next question comes from the line of Chris Raymond with Piper Sandler.

你的下一個問題來自 Chris Raymond 和 Piper Sandler 的台詞。

I got a question on Aimovig or maybe more strategically your neurology presence.

我有一個關於 Aimovig 的問題，或者更具戰略意義的是你的神經病學存在。

So just for the drug, obviously, revenue and script trends have kind of stalled and I think it's pretty obvious that the oral CGRPs that are sort of having an impact on the market.

因此，就藥物而言，顯然，收入和劇本趨勢已經停滯不前，我認為很明顯口服 CGRP 對市場產生了影響。

Murdo, I kind of noticed that you sort of skipped over that one in the prepared comments.

默多，我有點注意到你在準備好的評論中跳過了那個。

Maybe just sort of talk about your commitment to neurology now with this market dynamic.

也許只是在這種市場動態下談論你對神經病學的承諾。

Is this a category that we should expect more investment in from a product offering standpoint?

從產品提供的角度來看，我們是否應該期待更多的投資？

Is there may be some other plan here that you could maybe talk about?

這裡是否有其他計劃可以讓您談談？

Sure.

當然。

Thanks, Chris.

謝謝，克里斯。

The first thing I would say is Aimovig continues to be an important product to help patients suffering from migraine and we continue to believe that there is a large population of migraine sufferers who have yet to be helped by the advent of the CGRP category.

我要說的第一件事是 Aimovig 仍然是幫助偏頭痛患者的重要產品，我們仍然相信有大量偏頭痛患者尚未因 CGRP 類別的出現而得到幫助。

Obviously, as the market leaders in the subcutaneous category of CGRP products, we have given up share to the orals as they've come into the market, but they've also expanded the market beyond the preventative setting and into the acute setting.

顯然，作為 CGRP 皮下產品的市場領導者，我們在口服產品進入市場時放棄了份額，但它們也將市場從預防環境擴展到了急性環境。

And even the preventative setting has grown with the advent of the oral.

甚至預防性設置也隨著口腔的出現而增長。

So we expect that the market still has quite a bit of growth and headroom for growth.

因此，我們預計市場仍有相當大的增長空間和增長空間。

We expect to be able to continue to maintain our leadership share position in total prescriptions.

我們希望能夠繼續保持我們在總處方中的領先份額。

We have over 5 years now of safety and efficacy data in the market.

我們在市場上擁有超過 5 年的安全性和有效性數據。

We continue now to have all of the U.S. commercial responsibility for Aimovig given recent work to consolidate what Novartis was previously contributing.

鑑於最近的工作是鞏固諾華先前所做的貢獻，我們現在繼續對 Aimovig 承擔所有美國商業責任。

So we've actually increased our neurology presence in the last few months.

所以在過去的幾個月裡，我們實際上增加了我們的神經病學存在。

And then the last piece that we're excited about is we're awaiting our head-to-head superiority data versus topiramate to be published and after which we'll be able to promote that to general neurologists, headache specialists and even the many primary care physicians who are using Aimovig to help their patients who are chronic migraine sufferers.

最後讓我們興奮的是，我們正在等待我們與托吡酯的頭對頭優勢數據公佈，之後我們將能夠將其推廣給普通神經科醫生、頭痛專家甚至許多人使用 Aimovig 幫助慢性偏頭痛患者的初級保健醫生。

So a bit of headroom.

所以有點空間。

You're right on the oral evolution taking some growth out and also a little bit of net price in the quarter taking some growth out as well.

你是對的，口述演變消除了一些增長，並且本季度的一點淨價格也消除了一些增長。

And strategically, we'll continue to look and see if we can find products that fit well with the franchise that we're building, we'll continue to look for those.

從戰略上講，我們將繼續尋找並看看我們是否能找到與我們正在建立的特許經營權相匹配的產品，我們將繼續尋找那些。

Your next question comes from the line of Umer Raffat with Evercore ISI.

您的下一個問題來自於 Evercore ISI 的 Umer Raffat。

I feel like Amgen went through this period of getting a fair amount of credit for the clinical development and LUMAKRAS program.

我覺得安進經歷了這段時期，為臨床開發和 LUMAKRAS 項目獲得了相當多的讚譽。

And we might be sort of entering that phase where a lot of competitors have clinical stage programs on KRAS and were about to get a lot of data over the next few months.

我們可能會進入那個階段，很多競爭對手都有 KRAS 的臨床階段項目，並且即將在接下來的幾個月內獲得大量數據。

And I guess my question is, what's your base case on how sort of the clinical data across the field shakes out?

我想我的問題是，你對整個領域的臨床數據如何擺脫的基本案例是什麼？

Is this going to be a PD-1 like situation or everybody about the same?

這會是類似 PD-1 的情況還是每個人都差不多？

Or could you end up seeing approaches like RAS(ON) inhibitors, et cetera, look any different on resistance mutations.

或者你最終會看到像 RAS(ON) 抑製劑等方法，在耐藥性突變上看起來有什麼不同。

And a follow-up to that also, I feel like as we think about Amgen's leadership on KRAS target in the first place, should we expect Amgen to file INDs on other KRAS mutations like G12D or G12V?

以及後續行動，我覺得當我們首先考慮安進在 KRAS 靶標上的領導地位時，我們是否應該期望安進就 G12D 或 G12V 等其他 KRAS 突變提交 IND？

Thanks, Umer.

謝謝，烏默爾。

This is Dave.

這是戴夫。

As you mentioned, of course, there are multiple competitors coming behind LUMAKRAS.

正如您所提到的，當然，LUMAKRAS 背後有多個競爭對手。

We feel very good about our position.

我們對自己的位置感覺很好。

I've not seen anything to tell us that we don't have a really outstanding molecule.

我沒有看到任何東西可以告訴我們我們沒有真正出色的分子。

And many of those are very, very early, just starting dose escalation.

其中許多是非常非常早的，剛剛開始增加劑量。

So I think it's premature to speculate on potential differentiated mechanism of action or these sorts of things.

所以我認為現在推測潛在的差異化作用機製或這類事情還為時過早。

We also have a very broad-based global program.

我們還有一個非常廣泛的全球計劃。

As we've mentioned, we're now under regulatory review.

正如我們所提到的，我們現在正在接受監管審查。

I think at last count, it's now in over 15 jurisdictions or countries, including the EMA and Japan where reviews are progressing, and those are, of course, 2 very large markets.

我想最後統計一下，它現在在超過 15 個司法管轄區或國家，包括 EMA 和日本，審查正在進行中，當然，這些是 2 個非常大的市場。

So I feel very good about where we are.

所以我對我們所處的位置感覺很好。

We've got a large combination therapy program.

我們有一個大型的聯合治療計劃。

There's lots to learn yet.

還有很多東西要學。

It took 40 years to get into the clinic, and we're sorting out a lot of biology but I feel very good about the molecule we've got and where we are.

進入診所花了 40 年，我們正在整理很多生物學，但我對我們擁有的分子以及我們所處的位置感覺非常好。

Dave, do you want to say anything else about our G12D or V programs?

戴夫，您還想對我們的 G12D 或 V 計劃說些什麼嗎？

Sorry.

對不起。

Thanks for the reminder.

感謝您的提醒。

In terms of -- we are interested in other targets.

就 - 我們對其他目標感興趣。

As many of you know, there are 7 or 8 specific KRAS mutations that are now potentially attractable although they are different on a structural basis and each one poses distinct challenges.

正如你們許多人所知，有 7 或 8 個特定的 KRAS 突變現在可能具有吸引力，儘管它們在結構基礎上有所不同，並且每一個都帶來了不同的挑戰。

We do have some work ongoing.

我們確實有一些工作正在進行中。

And as that progresses, we will say more about that publicly.

隨著事情的進展，我們將公開更多地談論這一點。

Your next question comes from the line of Yaron Werber with Cowen.

您的下一個問題來自 Yaron Werber 和 Cowen 的對話。

This is Gabe on for Yaron.

這是 Yaron 的 Gabe。

Just for LUMAKRAS to follow up.

只是為了讓 LUMAKRAS 跟進。

So for the data with pembro that's expected in the first half of next year, can you kind of give us some maybe set the stage a little bit for whether the data will be mature enough for to get a good look at efficacy?

那麼對於預計在明年上半年使用 pembro 的數據，您能否給我們一些可能的數據，看看數據是否足夠成熟，可以很好地了解療效？

Will we have TPS status available for all patients?

我們會為所有患者提供 TPS 狀態嗎？

And then just for the second SHP2 combination arm that you recently added.

然後就是您最近添加的第二個 SHP2 組合臂。

Any insight you could share into the thinking behind adding TNO155?

您可以分享添加 TNO155 背後的想法的任何見解嗎？

Was there any difference in the profile compared to the RevMed molecule that you would highlight that might be a better overlap with LUMAKRAS?

與您要強調的可能與 LUMAKRAS 更好重疊的 RevMed 分子相比，該配置文件是否有任何差異？

Yes.

是的。

Thanks, Gabe.

謝謝，加布。

Yes, in terms of the -- what I would say broadly, the checkpoint inhibitor combination data, we do expect to have a fulsome enough data set when we have everything together and present at some point in the first half of next year to, I think, give good insights to the field about what these combinations look like.

是的，就我廣義上說的檢查點抑製劑組合數據而言，我們確實希望當我們將所有東西放在一起並在明年上半年的某個時候呈現時，我們會擁有足夠豐富的數據集，我想一想，就這些組合的樣子對該領域提供很好的見解。

In terms of the various SHP2 inhibitors for which we're pursuing combinations, there are some biochemical differences between those drugs and I think it's well worth our while given the potential importance and the mechanistic rationale of SHP2 as a combination target for us to examine those various molecules.

就我們正在尋求組合的各種 SHP2 抑製劑而言，這些藥物之間存在一些生化差異，鑑於 SHP2 作為組合目標的潛在重要性和機制原理，我認為值得我們研究這些藥物。各種分子。

And so we're pressing forward on all fronts.

所以我們在各個方面都向前推進。

Thank you.

謝謝你。

Your next question comes from the line of Geoffrey Porges with SVB Leerink.

您的下一個問題來自 SVB Leerink 的 Geoffrey Porges。

Maybe just another slightly big picture one, Bob and Murdo, I know you pay close attention to what's going on in D.C. And I'd be interested in whether you think that we are close to having a deal on drug pricing reform.

也許只是另一個稍微大一點的畫面，鮑勃和默多，我知道你們密切關注華盛頓正在發生的事情。我很想知道你們是否認為我們即將就藥品定價改革達成協議。

And particularly, could you give us a sense of what the financial impact on Amgen would be of the proposed Part D changes?

特別是，您能否讓我們了解擬議的 D 部分變更對安進的財務影響？

And then secondly, do you believe that you have any molecules that would be subject to negotiation under the proposed federal negotiation with Part B -- selected Part B drugs in the current language?

其次，您是否認為您有任何分子可以根據擬議的聯邦與 B 部分的談判進行談判——以當前語言選擇的 B 部分藥物？

Yes.

是的。

Thanks, Geoff.

謝謝，傑夫。

It's obviously very premature for anybody to pretend like they know what the shape of the new legislation will be.

對於任何人來說，假裝他們知道新立法的形式顯然還為時過早。

I don't think anybody has really seen any meaningful draft language yet.

我認為還沒有人真正看到過任何有意義的草案語言。

What we are aware of, of course, is that there's some tweeting and some back and forth between the House and the Senates, including moderates in both suggesting that they're close and that they think they have a framework that they can align around.

當然，我們知道的是，眾議院和參議院之間存在一些推特和一些來回，包括溫和派，兩者都暗示他們很接近，並且他們認為他們有一個可以調整的框架。

So we'll need to wait and see the details.

所以我們需要等待，看看細節。

And as you would expect, we'll be focused on seeing whether what they're proposing leads to better access for patients to medicines and whether it does that while preserving the ecosystem that enables all of us to innovate the way we do and the way we think we need to for the country.

正如您所期望的那樣，我們將專注於看看他們的提議是否會導致患者更好地獲得藥物，以及它是否能做到這一點，同時保護生態系統，使我們所有人都能創新我們的工作方式和方式我們認為我們需要為國家。

So stay tuned, Geoff, again, very premature.

所以請繼續關注，傑夫，再次，非常過早。

I know you guys would love to have a picture that you could share with your investors and a picture that would make some sense, but I think anybody trying to draw one at this point is really doing it in the way of sculpting fog.

我知道你們很想擁有一張可以與您的投資者分享的圖片，以及一張有意義的圖片，但我認為任何試圖在這一點上繪製的人實際上都是在以雕刻迷霧的方式來做。

Your next question comes from the line of Matthew Harrison with Morgan Stanley.

您的下一個問題來自摩根士丹利的 Matthew Harrison。

I was wondering if we could just touch a little bit on your outlook for product guidance.

我想知道我們是否可以稍微談談您對產品指導的看法。

It looks like you raised other revenue guidance, but you also took down the high end of your total company guidance.

看起來您提高了其他收入指導，但您也降低了公司總體指導的高端。

So maybe you could just talk about -- and that looks like about a $800 million swing if you add the 2 together.

所以也許你可以談談——如果你把這兩個加在一起，這看起來像是一個 8 億美元的搖擺。

So maybe you could just talk about what's the driver there and where you're seeing the pressure.

所以也許你可以談談那裡的驅動因素是什麼以及你在哪裡看到壓力。

Matthew, thank you, Peter here.

馬修，謝謝你，彼得在這裡。

Listen, on the revenue range, we're $25.8 billion to $26.2 billion reflects the latest market dynamics, as Murdo shared with you.

聽著，在收入範圍內，我們在 258 億美元到 262 億美元之間反映了最新的市場動態，正如 Murdo 與您分享的那樣。

Volume growth year-over-year from products, Prolia, Otezla, Repatha, EVENITY biosimilars, competition against the mature products, as I mentioned, but it's a great cash flow producers for us.

正如我所提到的，產品、Prolia、Otezla、Repatha、EVENITY 生物仿製藥的銷量同比增長，與成熟產品的競爭，但這對我們來說是一個很好的現金流生產者。

Look, the sharper recovery we had anticipated early hasn't materialized at the rate we projected, but the recovery continues at a steady but more gradual rate, as Murdo described for you.

看，我們早先預期的較快復甦並沒有以我們預計的速度實現，但正如默多為您描述的那樣，復甦繼續以穩定但更漸進的速度。

So we continue to build into guidance, mid-single-digit net price declines in '21.

因此，我們繼續將 21 年中個位數的淨價格下跌納入指導。

We've got other revenue at $1.5 billion to $1.7 billion.

我們的其他收入為 15 億至 17 億美元。

The increase year-over-year driven primarily by the Lilly manufacturing reimbursement profit share, which began in the second quarter, as we've said.

正如我們所說，同比增長主要是由禮來製造報銷利潤份額推動的，該份額始於第二季度。

And so those are the dynamics around the top side of the guidance.

所以這些是指南頂部的動態。

Just, Matt, I might just observe that relative to the beginning of the year, when we gave the original guidance, the COVID impact has lingered longer than I think we thought when we looked at this at the beginning of the year, in particular, in terms of the face-to-face visits and the number of patient diagnoses inside doctors' offices.

只是，馬特，我可能只是觀察到，相對於年初，當我們給出最初的指導時，COVID 影響的持續時間比我認為我們在年初看到這個時所認為的要長，特別是，在醫生辦公室內的面對面訪問和患者診斷數量方面。

So by now looking the retrospective scope, it's pretty clear that the surge had an impact on the number of patients going to see the doctors and in turn, prescriptions being written.

因此，現在回顧回顧範圍，很明顯，激增對去看醫生的患者數量產生了影響，進而影響了開出的處方。

So I don't think we're experiencing anything different from our peers.

所以我不認為我們正在經歷與同齡人不同的任何事情。

But at the start of the year, we were hopeful that vaccines and other things might have made us -- enabled us to be further along in saying goodbye to this pandemic than I think we are right now.

但是在今年年初，我們希望疫苗和其他東西可能使我們——使我們能夠比我現在認為的更進一步告別這種流行病。

But again, otherwise, business is performing well and consistent with where we hope to end the year.

但同樣，除此之外，業務表現良好，並且與我們希望在今年結束時保持一致。

Your next question comes from the line of Alethia Young with Cantor Fitzgerald.

您的下一個問題來自與 Cantor Fitzgerald 的 Alethia Young。

Maybe to follow up a little bit along with that.

也許要跟進一點。

Can you just talk a little bit about it like Repatha and Aimovig, some of the selling price pressure are you seeing?

你能像 Repatha 和 Aimovig 一樣談談它，你看到了一些售價壓力嗎？

And do you think that it's kind of a kind of a slow step down?

你認為這是一種緩慢的下降嗎？

Or is it kind of something that just we're having more periodically?

或者它只是我們定期擁有的東西？

Alethia, did you say Repatha and Aimovig.

Alethia，你說的是 Repatha 和 Aimovig。

Is that what you're asking?

你問的是這個嗎？

Yes.

是的。

Yes.

是的。

Yes.

是的。

Okay, sure.

好的，當然。

So Repatha in the quarter is more a function of what we've been able to do since lowering the price in terms of increasing our penetration in the Medicare Part D population.

因此，本季度的 Repatha 更像是我們在降低價格以提高我們在醫療保險 D 部分人群中的滲透率方面能夠做的事情。

So we've seen some really nice growth there.

所以我們在那裡看到了一些非常好的增長。

But what happens when you grow in Medicare Part D is you also grow in the number of patients that enter the donut hole.

但是，當您在 Medicare D 部分中成長時，您也會增加進入甜甜圈洞的患者數量。

And that's what we're really seeing in Q3, and we expect that to continue in Q4.

這就是我們在第三季度真正看到的情況，我們預計這將在第四季度繼續。

The good news side of that equation is we're growing nicely in Medicare.

這個等式的好消息是我們在醫療保險方面發展良好。

We're seeing much less patient abandonment in Medicare, and that should be a compounding source of growth for us on a go-forward basis.

我們看到醫療保險中患者被遺棄的情況要少得多，這應該是我們向前發展的複合增長源。

But I would expect a pattern of Q3 and Q4 net price drag as a function of the Medicare Part D coverage gap.

但我預計第三季度和第四季度的淨價格拖累是醫療保險 D 部分覆蓋缺口的函數。

Unless, of course, that changes in whatever is brewing in D.C. but that's how it's happened right now.

當然，除非華盛頓正在醞釀的任何事情都發生了變化，但這就是現在發生的事情。

On Aimovig, it's a little bit different.

在 Aimovig 上，情況有點不同。

It's just -- it's really the annualization of contracted business with PBMs in general.

這只是 - 這實際上是與 PBM 簽訂的合同業務的年度化。

There's been fairly competitive activity there to maintain preferred formulary positions on national PBMs.

那裡有相當競爭的活動來維持國家 PBM 的首選處方位置。

And we don't have the same amount of volume growth on Aimovig, but we do expect that to be more stable going forward.

而且我們在 Aimovig 上沒有相同數量的銷量增長，但我們確實預計未來會更加穩定。

So overall, I think our major price effects have stabilized, and we're actually now seeing some good top line volume drop to the bottom.

所以總的來說，我認為我們的主要價格影響已經穩定，實際上我們現在看到一些不錯的頂線交易量跌至谷底。

Your next question comes from the line of Jay Olson with Oppenheimer.

您的下一個問題來自 Jay Olson 與 Oppenheimer 的對話。

Is there any color you could provide on the pace of enrollment for the Phase II study of olpasiran?

對於奧帕西蘭 II 期研究的註冊進度，您是否可以提供任何顏色？

Also, any comments you could share on how you anticipate the competitive landscape to evolve in the lipoprotein A market with pelacarsen potentially getting approved before olpasiran?

此外，您可以分享任何關於您預計脂蛋白 A 市場的競爭格局如何演變的評論，因為 pelacarsen 可能在 olpasiran 之前獲得批准？

Yes.

是的。

Thanks, Jay.

謝謝，傑。

Yes, in terms of the Phase II study, it is actually completed enrollment.

是的，就第二階段的研究而言，它實際上是完成了註冊。

So of course, these patients are followed for some time.

因此，當然，這些患者會被跟踪一段時間。

And as I noted in my remarks, we expect data in the middle of 2022.

正如我在講話中指出的那樣，我們預計數據將在 2022 年年中發布。

We're quite pleased with the long-term follow-up we've seen from the Phase I trial in terms of Lp(a) lowering in the preliminary safety profile of the molecule.

我們對從 I 期試驗中看到的長期隨訪感到非常滿意，即 Lp(a) 降低了分子的初步安全性。

So that program is on track or if anything, a little ahead of schedule.

因此，該計劃正在按計劃進行，或者如果有的話，比計劃提前了一點。

As you know, there is another molecule ahead of us.

如你所知，我們前面還有另一個分子。

We have a slightly different mechanism as a small interfering RNA.

作為小干擾 RNA，我們的機制略有不同。

We like the molecule quite a bit.

我們非常喜歡這個分子。

This is a large population of patients.

這是一個龐大的患者群體。

Recall that about 50% of atherosclerotic cardiovascular disease is not driven by LDL-cholesterol and probably the majority of that is Lp(a) driven.

回想一下，大約 50% 的動脈粥樣硬化性心血管疾病不是由 LDL 膽固醇驅動的，而其中大部分可能是 Lp(a) 驅動的。

So we believe there are many, many patients around the world that can be served by Lp(a) lowering agents.

因此，我們相信世界上有許多患者可以使用 Lp(a) 降低劑。

And so we're quite eager to see the full Phase IIb data.

所以我們非常渴望看到完整的 IIb 期數據。

Your next question comes from the line of Ronny Gal with Bernstein.

您的下一個問題來自 Ronny Gal 與 Bernstein 的對話。

So we typically asked you about the negative impact of a potential deal in Washington.

因此，我們通常會詢問您有關華盛頓潛在交易的負面影響。

I was wondering if we can reverse it and talk about the benefits.

我想知道我們是否可以扭轉它並談論好處。

So to the extent there are any deal which limits patients out-of-pocket cost, what are the drugs who will benefit from increased use?

因此，如果有任何限制患者自付費用的協議，哪些藥物將從增加使用中受益？

What are the drugs where you see significant abandonment in Medicare Part D that might take or might get more use?

在 Medicare D 部分中，您發現哪些藥物可能會被大量使用或可能會得到更多使用？

And second, you started interchangeability trial for HUMIRA biosimilars.

其次，你們開始了 HUMIRA 生物仿製藥的互換性試驗。

Can you just talk a little bit about your change your perspective here?

你能在這裡談談你改變你的觀點嗎？

Do you believe that interchangeability will be required longer term to participate in this market?

您是否認為長期參與這個市場需要互換性？

And if not, what's the justification for the trial?

如果不是，審判的理由是什麼？

Thanks, Ronny.

謝謝，羅尼。

It's Murdo.

是默多。

So hypothetically speaking, should there be an out-of-pocket cap for patients in Part D introduced in some change in legislation, I think it would help in our portfolio.

所以假設性地說，如果在立法的某些變化中引入 D 部分的患者自付費用上限，我認為這將有助於我們的投資組合。

We've been advocates for changes to Part D in that regard for quite a while, where we do think that the out-of-pocket expenditures and the less price equation for co-pays for patients or disincentives to drug adherence and maybe even for initial fill.

很長一段時間以來，我們一直倡導在這方面對 D 部分進行修改，我們確實認為自付費用和較低的價格等式為患者共同支付或抑製藥物依從性，甚至可能初始填充。

So I think products like Repatha, where we are largely a Medicare Part D population, could benefit from out-of-pocket caps.

所以我認為像 Repatha 這樣的產品，我們主要是醫療保險 D 部分的人群，可以從自付費用上限中受益。

Now it would depend obviously, what that travels with.

現在它顯然取決於旅行的內容。

Does it travel with more commitment from the manufacturer in the catastrophic phase, where we pick up more of the tab.

它是否在災難性階段得到製造商的更多承諾，我們將獲得更多的標籤。

So it needs to be equated with other things that could be in any proposed legislation.

因此，它需要與任何擬議立法中可能包含的其他內容等同起來。

But I hope that out-of-pocket caps come into play because I think patients who are in Part D are sometimes treated poorly and are sub-optimally treated because of that, and it would improve their affordability.

但我希望自付費用上限發揮作用，因為我認為 D 部分的患者有時會受到較差的治療，因此治療效果不佳，這將提高他們的負擔能力。

To the question on the AMGEVITA interchangeability study, we continue to feel very good about our opportunity with AMGEVITA, being in that first wave and potentially alone in the first wave of biosimilar launches to HUMIRA in the U.S. affords us an opportunity to work with payers, work with the PBMs and with providers to establish a leadership position.

關於 AMGEVITA 可互換性研究的問題，我們繼續對我們與 AMGEVITA 的機會感到非常滿意，處於第一波並且可能獨自一人在美國向 HUMIRA 推出的第一波生物仿製藥為我們提供了與付款人合作的機會，與 PBM 和供應商合作建立領導地位。

We look at every parameter of a biosimilar product, and this is experienced from AMGEVITA itself in Europe, but it's also experience from our other biosimilar portfolio in the U.S., and we look at things like latex free, citrate free, we look at needle gauge, we look at device, and of course, we look at interchangeability.

我們查看生物仿製藥產品的每一個參數，這從歐洲的 AMGEVITA 本身得到了經驗，但也從我們在美國的其他生物仿製藥產品組合中得到了經驗，我們著眼於無乳膠、無檸檬酸鹽、針規等產品，我們看設備，當然，我們看互換性。

So while we don't think it's essential, we think it's just another attribute of the product that could augment our success in that launch in 2023.

因此，雖然我們認為這不是必不可少的，但我們認為它只是產品的另一個屬性，可以增強我們在 2023 年推出的成功。

So that's really why we've initiated the trial, Ronny.

所以這就是我們啟動試驗的真正原因，羅尼。

Your next question comes from the line of Kennen MacKay with RBC Capital Markets.

您的下一個問題來自 RBC Capital Markets 的 Kennen MacKay。

This is Sudan Loganathan on for Kennen.

這是Kennen的Sudan Loganathan。

So first, I wanted to ask on LUMAKRAS.

所以首先，我想問一下 LUMAKRAS。

So how much of an impact are you expecting LUMAKRAS having on the updated top end revenue guidance that you updated for 2021?

那麼，您期望 LUMAKRAS 對您為 2021 年更新的最新高端收入指南產生多大影響？

And then taking into account any competition entering the market in 2022, how do you plan to formulate revenue guidance based on that for 2022?

然後考慮到 2022 年進入市場的任何競爭，您計劃如何在此基礎上製定 2022 年的收入指導？

And then secondly, in regards to LUMAKRAS plus Vectibix third-line combo program for colorectal cancer, looking forward, how could this -- what could this mean for Vectibix if approved?

其次，關於 LUMAKRAS 加 Vectibix 三線聯合方案治療結直腸癌，展望未來，這怎麼可能——如果獲得批准，這對 Vectibix 意味著什麼？

Can we expect some growth in that program if this combination gets through to approval?

如果這種組合獲得批准，我們能否期望該計劃有所增長？

And then thirdly, just wanted to mention -- ask about the antibody manufacturing agreement with -- for Eli Lilly in COVID-19.

第三，只是想提一下——詢問與禮來公司在 COVID-19 中的抗體製造協議。

Is that still something we can expect to be included in the other revenue line item going forward?

這仍然是我們可以期待在未來的其他收入項目中包含的內容嗎？

And any update on that just based on the pandemic environment?

僅基於大流行環境的任何更新？

Yes.

是的。

Let's take the first question, and we can answer that.

讓我們來回答第一個問題，我們可以回答這個問題。

And the rest -- call me later, this is Arvind from Investor Relations, and we can address those questions separately.

其餘的 - 稍後給我打電話，我是投資者關係部的 Arvind，我們可以單獨解決這些問題。

So Dave, maybe you can address the question about LUMAKRAS.

所以戴夫，也許你可以解決關於 LUMAKRAS 的問題。

Sure.

當然。

I think it was related to Murdo and competition.

我認為這與默多和競爭有關。

Yes, more of a commercial question.

是的，更多的是商業問題。

So we obviously don't provide product level revenue guidance.

因此，我們顯然不提供產品級別的收入指導。

But I'll say this.

但我會說這個。

I've worked in oncology for many years now, and I've been a part of some important lung cancer product launches.

我在腫瘤學領域工作了很多年，並且參與了一些重要的肺癌產品發布。

And this launch after 40 years of trying to solve the KRAS G12C conundrum in lung cancer, this launch has been very special.

而這次在試圖解決肺癌中KRAS G12C難題40年後的推出，這次推出非常特別。

And the team has done an excellent job of executing across the payer customers, our provider customers and of course, for patients.

該團隊在付款人客戶、我們的供應商客戶，當然還有患者方面做得非常出色。

And I was very proud of what our R&D organization was able to do and the speed at which they brought this product to market, and I feel that the medical and commercial organizations have taken the customer-facing stage and the go-to-market stage of this launch extremely seriously and with a lot of responsibility.

我為我們的研發組織能夠做到的事情以及他們將這個產品推向市場的速度感到非常自豪，我覺得醫療和商業組織已經進入了面向客戶的階段和進入市場的階段這次發射非常認真，責任重大。

And so far, it's early days, but so far, they've done very, very well.

到目前為止，還處於早期階段，但到目前為止，他們做得非常非常好。

And so I'm pleased with the trajectory.

所以我對這個軌跡很滿意。

What we're seeing is many academic centers are changing their testing protocols in lung cancer so that everybody knows their KRAS G12C status.

我們看到的是，許多學術中心正在改變他們的肺癌檢測方案，以便每個人都知道他們的 KRAS G12C 狀態。

Many large community oncology networks have done the same.

許多大型社區腫瘤學網絡也這樣做了。

Now we still have a few large community oncology networks to go.

現在我們還有一些大型社區腫瘤學網絡要走。

So we will be working on those in the fourth quarter, but I couldn't be more pleased with the way in which we've entered the market.

所以我們將在第四季度進行這些工作，但我對我們進入市場的方式感到非常滿意。

And I think that bodes well for our ability to establish a strong leadership position and help many, many patients who are unfortunately progressing from first-line into second-line disease before competitors come in.

我認為這預示著我們有能力建立強大的領導地位並幫助許多不幸在競爭對手進入之前從一線疾病進展到二線疾病的患者。

It's hugely rewarding to launch a product like this where you hear stories of patients who have been told that their options are limited and that they should sign up for hospice care, coming out of hospice and getting treated with LUMAKRAS with commercial drug and responding.

推出這樣的產品是非常有益的，您會聽到患者的故事，他們被告知他們的選擇有限，他們應該註冊臨終關懷，走出臨終關懷並接受 LUMAKRAS 商業藥物治療並做出反應。

And the drug is working well in the marketplace.

該藥物在市場上運行良好。

We're hearing those anecdotal stories coming back from prescribers, and we will continue to do everything within our power to continue to launch LUMAKRAS quickly around the world and help many, many more patients.

我們從處方醫生那裡聽到了這些軼事，我們將繼續盡我們所能，繼續在世界各地快速推出 LUMAKRAS 並幫助更多、更多的患者。

Great.

偉大的。

Thanks, Murdo.

謝謝，默多。

Erica, let's take the next question, please.

艾麗卡，請讓我們回答下一個問題。

Your next question comes from the line of Robyn Karnauskas with Truist Securities.

您的下一個問題來自 Truist Securities 的 Robyn Karnauskas。

Maybe a glass half empty one and a glass half full one.

也許一杯半空的和一杯半滿的。

I'll start off with the glass half empty.

我將從半空的杯子開始。

And so when I look at what's going on with your business, I mean, I think what we've heard on the call a lot is pricing pressure, despite your growth and your great marketing strategy.

因此，當我查看您的業務正在發生的事情時，我的意思是，我認為我們在電話會議上聽到的很多是定價壓力，儘管您的增長和您的營銷策略很好。

And then you've got a pipeline that's got a lot of competitors that are going to compete with it because there's a lot of people out there with either similar molecules or competing molecules.

然後你有一個管道，它有很多競爭對手將與之競爭，因為那裡有很多人擁有相似的分子或競爭分子。

So on that question, it's how -- any change in strategy for development and picking next-generation R&D candidates going forward for any tool kits or platforms that you might need to develop a drug.

因此，在這個問題上，它是如何改變開發策略並為開發藥物可能需要的任何工具包或平台挑選下一代研發候選人。

And then the half full question is you have this great opportunity in lung or you did a great job with LUMAKRAS developing that drug.

然後半滿的問題是你在肺部有這個很好的機會，或者你在 LUMAKRAS 開發這種藥物方面做得很好。

Can you talk a little bit about marketing strategy?

你能談談營銷策略嗎？

You could have competition here, but you could stay ahead of that competition with all the drugs that you're developing.

你可以在這裡進行競爭，但你可以在你正在開發的所有藥物的競爭中保持領先。

Walk us through, remind us of the strategy at Amgen for making sure that you're the dominant player even in a multiple player environment?

引導我們，提醒我們安進的策略，以確保即使在多人環境中你也是主導者？

Maybe let's go in reverse order, Murdo, why don't you start and then Dave can finish.

也許讓我們按相反的順序來吧，默多，你為什麼不開始，然後戴夫可以完成。

Well, not to belabor the point, but again, I've worked in the oncology field for a number of years.

好吧，不強調這一點，但我在腫瘤學領域工作了很多年。

And what I've seen since coming to Amgen is real strength in the legacy of Amgen, which is, of course, the support of care products that we have.

自從來到安進以來，我所看到的是安進遺產的真正實力，當然，這就是我們擁有的護理產品的支持。

We've augmented that recently with the launch of our biosimilar portfolio.

我們最近通過推出我們的生物仿製藥產品組合增強了這一點。

And then most recently, of course, with the launch of LUMAKRAS.

然後是最近，當然，隨著 LUMAKRAS 的推出。

And when I sit down with CEOs of cancer networks or academic cancer centers, they are very interested in talking to Amgen.

當我與癌症網絡或學術癌症中心的首席執行官坐下來時，他們對與安進交談非常感興趣。

And they are also interested in talking to us about the very rich pipeline of products that David Reese and his R&D colleagues are developing.

他們也有興趣與我們討論 David Reese 和他的研發同事正在開發的非常豐富的產品線。

So I think we are very much a leader in oncology.

所以我認為我們是腫瘤學領域的領導者。

I think that our commercial position with innovative products and biosimilars and launches of new therapeutics puts us in a very strong account position.

我認為我們在創新產品和生物仿製藥以及新療法推出方面的商業地位使我們處於非常強大的客戶地位。

And I think in a world where a lot of care is delivered in community oncology, our relationships there are extremely strong.

而且我認為在社區腫瘤學提供大量護理的世界中，我們的關係非常牢固。

I've been able to make some customer visits this year despite some of the interruptions of the pandemic.

儘管大流行造成了一些干擾，但今年我還是能夠拜訪一些客戶。

And most of my visits have been in support of the LUMAKRAS launch.

我的大部分訪問都是為了支持 LUMAKRAS 的發布。

And I can tell you they have been very, very good at working with us to develop testing programs, look back programs, entering flags and EMRs and making sure patients are flagged for treatment.

我可以告訴你，他們非常非常擅長與我們合作開發測試程序、回顧程序、輸入標記和 EMR，並確保患者被標記為接受治療。

And it's those systems and those processes that being first on the ground, we should be able to build and sustain.

正是這些系統和流程首先落地，我們應該能夠建立和維持。

Longer term, of course, it will be the continuation of being first with indications and being broad in the development of the asset and then supporting it with additional products in lung cancer that Dave is developing in our pipeline.

當然，從長遠來看，這將是繼續首先提供適應症並廣泛開發資產，然後用 Dave 在我們的管道中開發的其他肺癌產品來支持它。

Thanks, Robyn.

謝謝，羅賓。

Yes, in terms of toolkits, we could obviously talk probably for hours about the toolkits that we've got in discovery research and our clinical trials.

是的，就工具包而言，我們顯然可以談論幾個小時來談論我們在發現研究和臨床試驗中獲得的工具包。

Let me focus on just a couple of things for the purposes of this discussion.

為了討論的目的，讓我只關注幾件事。

We are building what I think is an industry-leading capability in what I call human data, which means the collection, integration and interrogation of data ranging from various omic data, genomic data, transcriptomic data, proteomic data through clinical trials data through real-world evidence in real-world data.

我們正在構建我認為是行業領先的能力，我稱之為人類數據，這意味著收集、整合和查詢數據，從各種組學數據、基因組數據、轉錄組數據、蛋白質組數據到臨床試驗數據，再到實時數據。現實世界數據中的世界證據。

And it's one of our core beliefs that the coming few decades will be won by those who understand how to make use of and, in particular, analyze the giant tsunami of data that is now starting to wash over us.

我們的核心信念之一是，那些了解如何利用，尤其是分析現在開始席捲我們的巨大數據海嘯的人將贏得未來幾十年的勝利。

Now that data, of course, generates drug targets and pathways.

當然，現在這些數據會生成藥物靶點和途徑。

And as I mentioned in my prepared remarks, we are building extensive capabilities for the development of multi-specific molecules, either small molecules, large molecules or hybrid molecules.

正如我在準備好的評論中提到的那樣，我們正在建立廣泛的能力來開發多特異性分子，無論是小分子、大分子還是混合分子。

About 80% to 85% of the currently validated targets are currently not approachable with existing technologies, and we are building the capability to go after what I think will be a good traction of those undruggable targets.

目前，大約 80% 到 85% 的經過驗證的目標目前無法通過現有技術實現，我們正在建立能力去追求那些我認為對那些不可成藥的目標有很好的吸引力。

So I feel great about the platforms that we've got in place and are continuing to build on and a lot more on this over the next year or 2.

因此，我對我們已經建立的平台感覺很好，並且在接下來的一兩年內將繼續在此基礎上進行更多建設。

Your next question comes from the line of Cory Kasimov with JPMorgan.

您的下一個問題來自摩根大通的 Cory Kasimov。

This is Gavin on for Cory.

這是科里的加文。

Maybe one for Murdo.

也許是給默多的一個。

Just curious about the expected impact of Otezla's mild-to-moderate label expansion.

只是對 Otezla 輕度至中度標籤擴張的預期影響感到好奇。

Specifically, should we expect immediate uptick in 2022?

具體來說，我們是否應該期望在 2022 年立即回升？

Or is something that will be a little more gradual?

或者是一些更漸進的東西？

And then secondly, just geographic expansion was underscored as a key strategy for the growth profile for this product and rest of the world has been around 20% of total sales.

其次，僅強調地域擴張是該產品增長概況的關鍵戰略，而世界其他地區的銷售額約佔總銷售額的 20%。

So just curious if that trend is going to continue?

所以只是好奇這種趨勢是否會持續下去？

Yes.

是的。

Thank you, Gavin.

謝謝你，加文。

When we acquired Otezla, I thought it would be a really good add to the portfolio and our strength in immunology, both with dermatology and with rheumatology.

當我們收購 Otezla 時，我認為這將是對產品組合和我們在免疫學（包括皮膚病學和風濕病學）實力的一個非常好的補充。

And obviously, we had to make a certain set of assumptions about how that product would evolve in our ownership.

顯然，我們必須對該產品如何在我們的所有權中發展做出一定的假設。

And so far, I have to say I'm even more pleased with the strength that the product brings to Amgen.

到目前為止，我不得不說我對該產品給安進帶來的力量感到更加滿意。

We've been successful, as you highlight, in demonstrating the product's efficacy and safety in the mild-to-moderate patient setting, which is a perfect sweet spot for this product, given the convenience of its oral dosing, given the well demonstrated safety and efficacy of the product.

正如您所強調的那樣，我們已經成功地展示了該產品在輕度至中度患者環境中的功效和安全性，鑑於其口服給藥的便利性，鑑於已充分證明的安全性，這是該產品的完美最佳選擇和產品的功效。

We also recently had a decision on the patent for Otezla, which definitely helps make it a very strategic product for us, a very important product for the growth of the company.

我們最近還對 Otezla 的專利做出了決定，這絕對有助於使其成為對我們來說非常具有戰略意義的產品，對於公司的發展來說是非常重要的產品。

And the fit is just perfect.

而且合身非常完美。

We have integrated the legacy Celgene team fully into Amgen.

我們已將傳統的 Celgene 團隊完全整合到 Amgen 中。

We've got both Enbrel and Otezla now being promoted in rheumatology and dermatology.

Enbrel 和 Otezla 現在都在風濕病學和皮膚病學領域得到推廣。

And we've seen volume growth improve in most markedly in the last part of Q3, but that continues into Q4.

我們已經看到第三季度最後一部分的銷量增長最為顯著，但這種情況一直持續到第四季度。

We didn't plan on a pandemic when we did the transaction, obviously, but we've weathered it well.

顯然，我們在進行交易時並沒有計劃應對大流行，但我們已經很好地度過了它。

The team is staying focused, and we are well prepared for the mild-to-moderate launch.

團隊保持專注，我們為輕度到中度的發布做好了充分的準備。

We're anticipating a decision on that soon from the FDA.

我們期待 FDA 很快對此做出決定。

We have the resources available.

我們有可用的資源。

We have the teams trained.

我們訓練了團隊。

We have an increased footprint in dermatology in anticipation of the approval.

期待獲得批准，我們在皮膚病學領域的足蹟有所增加。

And we expect to be able to execute very effectively.

我們希望能夠非常有效地執行。

We also have very, very strong payer coverage here.

我們在這裡也有非常非常強大的付款人覆蓋面。

And we think that the majority of these mild-to-moderate patients, and we're targeting a specific subset.

我們認為這些輕度至中度患者中的大多數，我們針對的是特定的子集。

We're targeting those patients that have larger body surface area or very difficult to treat areas with topicals.

我們的目標是那些體表面積較大或局部難以治療區域的患者。

So that's about a 1.5 million patient population.

因此，這大約是 150 萬患者。

So it's a large opportunity.

所以這是一個很大的機會。

But we think that the profile of the product, the price point of the product versus biologics puts us in a very, very strong position to treat these patients.

但我們認為，產品的概況、產品與生物製劑的價格點使我們在治療這些患者方面處於非常非常有利的地位。

The other thing I would add that we expect to benefit from somewhat more so in the PSA area versus psoriasis, but the safety concerns of the JAKs right now, quite frankly, are helping Otezla and the overall perception of our safety and our efficacy.

我要補充的另一件事是，我們希望在 PSA 領域與銀屑病相比受益更多，但坦率地說，現在 JAK 的安全問題正在幫助 Otezla 以及對我們安全性和療效的整體看法。

And I think that might bode well for future competition that's currently in the process, I guess, of being filed with the FDA.

而且我認為這可能預示著未來的競爭，我猜想，目前正在向 FDA 提交申請。

Your next question comes from the line of Carter Gould with Barclays.

您的下一個問題來自於 Barclays 的 Carter Gould。

Maybe to change it up a little bit.

也許可以稍微改變一下。

I wanted to ask around the line extension strategy for tezepelumab into EoE, how you think about the attractiveness of EoE, given that it's increasingly caught the attention of larger biopharma.

我想問一下 tezepelumab 進入 EoE 的產品線擴展策略，鑑於 EoE 越來越受到大型生物製藥公司的關注，您如何看待 EoE 的吸引力。

And I guess alongside that, when your partner disclosed the orphan drug designation, they talked about a planned Phase III.

我想除此之外，當您的合作夥伴披露孤兒藥名稱時，他們談到了計劃中的第三階段。

Should that be the expectation that you'll move straight into Phase III versus doing some Phase II work here?

這應該是您直接進入第三階段而不是在這裡做一些第二階段工作的期望嗎？

Yes.

是的。

Thanks, Carter.

謝謝，卡特。

Eosinophilic esophagitis or EOE, as it's called in the field, is an increasingly diagnosed condition.

嗜酸性食管炎或 EOE，正如它在該領域所稱的那樣，是一種越來越多的診斷疾病。

Patients with heartburn now who typically would have been diagnosed with reflux over the previous decade, a fair number of those are now recognized to have eosinophilic esophagitis given the mechanism of action of tezepelumab, given what we've seen in some of our biomarker and tissue acquisition studies in asthma based on eosinophil depletion in target tissue.

現在的胃灼熱患者通常會在過去十年被診斷出患有反流，鑑於我們在一些生物標誌物和組織中看到的情況，鑑於 tezepelumab 的作用機制，現在有相當多的患者被認為患有嗜酸性食管炎基於靶組織中嗜酸性粒細胞耗竭的哮喘採集研究。

This makes a lot of sense.

這很有意義。

And that is why with our partners, we are carrying this forward into Phase III based on the Phase I data that we have generated.

這就是為什麼我們與我們的合作夥伴一起根據我們生成的第一階段數據將其推進到第三階段。

So I think it's the evidence package across the molecule here that supports that.

所以我認為這是支持這一點的整個分子的證據包。

Erica, as we are getting close to the top of the hour, why don't we take one more question, after which I'll ask Bob to make some concluding comments.

埃麗卡，當我們接近一小時的時候，我們為什麼不再提一個問題，之後我會請鮑勃做一些總結性評論。

Your final question comes from the line of Michael Schmidt with Guggenheim.

你的最後一個問題來自古根海姆的邁克爾施密特。

This is Kelsey on for Michael.

這是邁克爾的凱爾西。

Could you maybe just discuss kind of your latest thoughts around potential accelerated approval opportunity in the frontline setting for lung cancer?

您能否談談您對肺癌一線潛在加速審批機會的最新想法？

And maybe when you might expect to have kind of a clear path forward one way or the other from the FDA?

也許當您可能期望從 FDA 以一種或另一種方式向前邁進時？

Yes.

是的。

Thanks for the question.

謝謝你的問題。

The FDA has been generally clear that in the first-line setting, randomized data are required.

FDA 普遍明確，在一線環境中，需要隨機數據。

We are, as I indicated, conducting a trial in patients with STK11 and/or PD-L1 negative or low tumors where checkpoint inhibitors are not particularly effective.

正如我所指出的，我們正在對檢查點抑製劑不是特別有效的 STK11 和/或 PD-L1 陰性或低腫瘤患者進行試驗。

When we have those Phase II data available, of course, if we saw interesting data, we would have the appropriate discussions with regulators.

當然，當我們有這些 II 期數據可用時，如果我們看到有趣的數據，我們會與監管機構進行適當的討論。

But I think the general expectation is that barring significant results, one will expect randomized trials in frontline lung cancer.

但我認為普遍的預期是，除非取得重大成果，否則人們會期待一線肺癌的隨機試驗。

Bob?

鮑勃？

Okay.

好的。

Well, let me thank all of you again for your -- for joining our call, and we look forward to having an opportunity to meet with you in the new year when we report on the fourth quarter.

好吧，讓我再次感謝你們所有人加入我們的電話會議，我們期待在新的一年裡有機會在我們報告第四季度時與你們見面。

We obviously have a lot of exciting things happening between now and then, again, starting, we expect with the expanded label for Otezla to be followed by the launch label for tezepelumab and the beginnings of a number of new Phase III trial programs, as we indicated on the call.

從現在到現在，我們顯然有很多令人興奮的事情發生，再次開始，我們預計 Otezla 的擴展標籤之後將是 tezepelumab 的發布標籤以及一些新的 III 期試驗計劃的開始，因為我們通話中註明。

So exciting time for us.

對我們來說如此激動人心的時刻。

Look forward to gathering with you in the new year.

新的一年，期待與您相聚。

Again, thanks for your support.

再次感謝您的支持。

Great.

偉大的。

Thanks, everybody.

謝謝大家。

This concludes Amgen's Third Quarter 2021 Financial Results Conference Call.

安進公司 2021 年第三季度財務業績電話會議到此結束。

You may now disconnect.

您現在可以斷開連接。