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

我叫艾莉卡，今天我將擔任安進公司 2021 年第三季財務業績電話會議的主持人。（操作員指示）現在我謹向大家介紹投資人關係副總裁 Arvind Sood。蘇德先生，您可以開始了。

Erica, thank you. Good afternoon, everybody. Welcome to our Q3 call. I think the 3 key themes for this quarter are continued execution, pipeline advancement and preparedness to launch important new products. So let's get started. The slides have been posted. A quick reminder that we'll use non-GAAP financial measures in our presentation, and some of the statements will be forward-looking statements. Our SEC filings identify factors that could cause our actual results to differ materially.

艾麗卡，謝謝你。大家下午好。歡迎參加我們的第三季電話會議。我認為本季的三大關鍵主題是：持續執行、推進產品線以及為推出重要新產品做好準備。那麼，我們就開始吧。幻燈片已上傳。提醒各位，我們的簡報將使用非GAAP財務指標，其中一些陳述屬於前瞻性陳述。我們向美國證券交易委員會提交的文件列出了可能導致實際業績與預期業績有重大差異的因素。

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

那麼，接下來我想把電話交給我們的董事長兼執行長鮑伯‧布拉德韋，鮑伯？

Okay. Hello, everyone, and thank you for joining our call. 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. Earnings per share for the quarter grew 11%, thanks to disciplined management of our operating expenses.

好的。大家好，感謝各位參加我們的電話會議。安進公司又迎來了一個穩健成長的季度，總收入成長了 4%，這主要得益於銷量成長了 8%，反映了全球對我們許多創新藥物（如 Repatha 和 Prolia）以及高品質生物相似藥的強勁需求。由於我們對營運費用進行了嚴格的管理，本季每股收益成長了 11%。

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

邁向未來。隨著我們開始展望後新冠疫情時代，我相信我們已經為實現長期可觀的成長做好了充分準備。舉例來說，我想提請大家注意我們的免疫學和腫瘤學產品組合，在這些領域，我們透過內部創新和策略業務發展相結合的方式，鞏固了我們以往的成功業績，我們期望這將有助於我們的長期成長。

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. 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. This product builds on our many years of success in inflammation, first with Enbrel and now, of course, with Otezla. We remain optimistic about the growth potential of Otezla. 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.

在發炎領域，我們對 tezepelumab 感到非常興奮，這是一種用於治療嚴重氣喘的首創療法，我們希望明年在美國推出。鑑於數百萬名氣喘患者無法獲得足夠的治療，我們相信 tezepelumab 將在未來幾年成為我們重要的成長動力。這款產品建立在我們多年來在抗發炎領域的成功之上，首先是恩利（Enbrel），當然現在還有奧特茲拉（Otezla）。我們對 Otezla 的成長潛力依然保持樂觀。下一步，我們熱切期盼該藥物在美國擴大適應症範圍，用於治療輕度至中度斑塊狀銀屑病，尤其是在一些潛在的新競爭對手出現之際。

We also continue to grow Otezla globally with the product now available in over 40 countries, up from 32 countries when we acquired it. Looking a bit further into the future, we expect to bring AMGEVITA, our biosimilar to HUMIRA to the U.S. in 2023. We expect to replicate the success we've had with AMGEVITA in many other markets around the world. 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.

我們也繼續在全球發展 Otezla，該產品目前已在 40 多個國家/地區銷售，而我們收購它時只有 32 個國家。展望未來，我們預計將於 2023 年將我們的 HUMIRA 生物相似藥 AMGEVITA 引入美國。我們期望將 AMGEVITA 的成功複製到世界各地的許多其他市場。我們也對 AMG 451 充滿熱情，這是一種已進入 III 期臨床試驗階段的潛在首創異位性皮膚炎治療藥物，我們正在與合作夥伴 Kyowa Kirin 對其進行研究。此外，我們也對安進公司目前處於 II 期臨床試驗階段的多種狼瘡和乳糜瀉療法充滿熱情。

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. LUMAKRAS joins a portfolio of medicines already generating some $10 billion a year in sales. Several of these medicines delivered double-digit sales growth in the third quarter, including KYPROLIS, BLINCYTO and MVASI.

在腫瘤學領域，我們很高興LUMAKRAS最近在美國上市，它是我們首創的KRAS G12C抑制劑，用於治療非小細胞肺癌。我們期待隨著我們不斷推進，在全球主要市場獲得更多批准和上市。LUMAKRAS 加入了一個年銷售額已達約 100 億美元的藥品組合。第三季度，其中幾種藥物的銷售額實現了兩位數的成長，包括 KYPROLIS、BLINCYTO 和 MVASI。

Looking ahead, we're excited about the growth potential of several other oncology assets in our pipeline. We've initiated already our first Phase III trial for bemarituzumab, a potential first-in-class molecule to treat gastric and gastroesophageal junction cancers. 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.

展望未來，我們對研發管線中其他幾項腫瘤治療產品的成長潛力感到興奮。我們已經啟動了貝馬裡單抗（bemarituzumab）的首個 III 期試驗，這是一種潛在的首創分子，用於治療胃癌和胃食道交界處癌。我們內部發現的幾種實體腫瘤BiTE分子也取得了良好的進展，包括一種用於前列腺癌，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. All that gives me confidence in our ability to serve more patients around the world and to deliver strong financial performance for our shareholders.

簡而言之，我們目前已有多款產品上市，並且還有很大的成長空間；未來幾年，我們的研發管線還將推出更多產品；我們擁有強大的研發引擎，可以不斷補充研發管線；我們也有能力抓住出現的重大業務發展機會。這一切都讓我對我們有能力服務世界各地更多患者以及為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. 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.

最後，我要感謝安進的同事們對病人和我們業務的持續投入。上週，我們非常榮幸被《財星》雜誌評為全球 25 個最佳工作場所之一，體現了我們員工的優秀素質以及他們對工作的熱情和卓越表現。

Dave, let me turn it over to you.

戴夫，接下來交給你了。

Thanks, Bob, and good afternoon, everyone. I would like to begin by welcoming our new colleagues from Teneobio, who bring expertise and technologies that will accelerate our innovation. One of our core areas of interest in research and molecular engineering is the development of multi-specific drugs to make undruggable targets tractable. 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. More than 60% of the molecules in our preclinical pipeline are multi-specifics. We will have more to say as those programs advance. 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.

謝謝你，鮑勃，大家下午好。首先，我謹代表 Teneobio 向我們的新同事表示歡迎，他們帶來的專業知識和技術將加速我們的創新。我們在研究和分子工程領域的核心興趣領域之一是開發多特異性藥物，使無法成藥的標靶變得可控。收購 Teneobio，加上我們先前整合的 Nuevolution 及其 DNA 編碼庫技術，使我們能夠開發大分子和小分子多特異性藥物，這很好地體現了我們如何結合內部和外部創新資源來推進研發組合。我們臨床前研發管線中超過 60% 的分子是多特異性分子。隨著這些項目的推進，我們將有更多消息要說。在研發方面，我們專注於建立特定疾病領域的互補資產組合，以幫助推動公司的長期成長。

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. In oncology, one key area of focus is lung cancer. As you'll hear from Murdo, the LUMAKRAS launch is off to an excellent start, and the clinical programs remain on track. 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. 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.

接下來談談我們的臨床項目，我將重點介紹幾個我們取得重大進展並正在推進多個同類首創分子研發的領域。在腫瘤學領域，肺癌是重點研究領域之一。正如 Murdo 所說，LUMAKRAS 的推出取得了非常好的開端，臨床計畫也仍在按計畫進行。我們已啟動 LUMAKRAS 單藥治療一線非小細胞肺癌的 II 期研究，對象為 STK11 突變和/或 PD-L1 陰性腫瘤患者。我們繼續期待明年上半年公佈與多西他賽進行 III 期確證性研究的主要結果，以及 PD-1 聯合療法和 SHP 聯合療法隊列的數據。

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

在針對小細胞肺癌 DLL3 的 tarlatamab 或 AMG 757 BiTE 計畫中，I 期試驗中一些病情非常嚴重的患者已經獲得了持續一年以上的療效，這支持了我們可能開展的 II 期註冊研究，我們計劃在年底前啟動該研究。最後，在鱗狀非小細胞肺癌中，我們將在未來幾個月啟動一項針對 FGFR2b 的 bemarituzumab 的 Ib 期研究。

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

接下來談談胃腸道癌症。我們將在未來幾週內開始招募 LUMAKRAS 與 Vectibix 聯合用於第三線大腸直腸癌治療的 III 期試驗患者。在胃癌第一線治療中，我們已經啟動了多項貝馬妥珠單抗 III 期研究中的第一項，未來幾個月也將啟動更多試驗。這些研究將探討貝馬妥珠單抗合併基礎化療或化療合併免疫檢查點抑制劑治療胃癌的區域差異。

Prostate cancer is another area of focus in oncology. With the acquisition of Teneobio, we now have 2 distinct bi-specific T cell engager technologies targeting PSMA. 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. 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. Finally, rounding out our prostate cancer portfolio is AMG 509, targeting STEAP1, which is also progressing through dose escalation. We anticipate having decision-making data next year.

前列腺癌是腫瘤學領域的另一個重點研究方向。透過收購 Teneobio，我們現在擁有 2 種針對 PSMA 的雙特異性 T 細胞銜接器技術。我們預計在明年上半年，acapatamab AMG 160 計畫的擴展隊列將提供決策支援數據，目前我們正在探索門診給藥方案。AMG 340（原名 TNB-585）繼續進行劑量遞增試驗，我們預計到明年年中也將獲得有價值的數據，以便確定這兩種 PSMA 分子中一種或兩種的最佳前進方向。最後，我們前列腺癌產品組合中的 AMG 509 也正在透過劑量遞增試驗來完善我們的產品組合，該藥物針對 STEAP1。我們預計明年將獲得決策數據。

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. In the tezepelumab program, regulatory reviews in severe asthma are proceeding with an FDA action date in the first quarter of 2022. Studies in 3 additional indications are in progress to investigate the utility of tezepelumab across a range of inflammatory diseases.

在發炎領域，我們幾週前詳細討論了我們創新藥物和生物相似藥產品組合日益活躍的情況，以及未來幾年內預計獲得的監管批准和產品上市情況。在 tezepelumab 計畫中，針對重度氣喘的監管審查正在進行中，FDA 將於 2022 年第一季做出決定。目前正在進行針對另外 3 種適應症的研究，以調查 tezepelumab 在多種發炎性疾病中的應用價值。

In skin autoimmune diseases, the FDA review of Otezla for mild-to-moderate psoriasis continues with a PDUFA date in December. 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. 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. We have had productive regulatory interactions on the program and plan to launch Phase III trials in the first half of 2022. Finally, we also expect Phase III data from biosimilar candidates to STELARA, EYLEA and SOLIRIS in the inflammation portfolio next year.

在皮膚自體免疫疾病方面，FDA 對 Otezla 用於治療輕度至中度乾癬的審查仍在繼續，PDUFA 日期定於 12 月。幾週前，我們公佈了 AMG 451 (KHK4083) 的 II 期研究結果。 AMG 451 是一種首創的雙效抗 OX40 抗體，我們正在與 Kyowa Kirin 合作開髮用於治療異位性皮膚炎。這些數據受到了醫學界的廣泛好評，因為對於這些患者來說，顯然需要具有不同作用機制的創新療法。我們已就該計畫與監管機構進行了富有成效的互動，並計劃於 2022 年上半年啟動 III 期試驗。最後，我們也預計明年將公佈發炎產品組合中 STELARA、EYLEA 和 SOLIRIS 的生物相似藥候選藥物的 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. 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.

在心血管代謝疾病和動脈粥狀硬化方面，針對約 12,000 名心血管高風險但先前沒有心肌梗塞或中風的患者進行的 Repatha VESALIUS 試驗 III 期結果研究預計將在未來幾週內完成入組。Olpasiran 是一種針對 Lp(a) 的小幹擾 RNA，也是我們首個基於 RNA 的療法，目前仍按計劃在 2022 年年中公佈 IIb 期數據，並且有望成為 Repatha 在治療動脈粥樣硬化性心血管疾病方面的補充，適用於病理並非由 LDL 膽固醇驅動的患者。

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.

總而言之，憑藉創新的產品組合（其中約 3/4 的臨床階段項目具有同類首創的潛力）和不斷增長的生物相似藥產品組合，我們完全有能力在短期和長期內繼續為患者提供重要的新藥，並為股東帶來成長。

Murdo?

默多？

Thank you, Dave. Third quarter product sales increased 4% year-over-year. Volumes increased 8% globally, and we had record quarterly sales for several of our key products, including EVENITY, KYPROLIS, XGEVA and Nplate. Our ex U.S. business grew 19% with volume growth of 25% year-over-year. We continue to execute our volume-driven growth strategy and see gradual recovery in our business from the impact of the pandemic. During the early part of Q3, we saw volatility in patient care dynamics due to a surge in COVID-19. As we progressed through the quarter, we saw improvement in patient visits and diagnoses. Total customer activity improved during Q3. However, face-to-face customer interactions remain below 2019 levels.

謝謝你，戴夫。第三季產品銷售額年增 4%。全球銷售成長了 8%，我們的幾款主要產品，包括 EVENITY、KYPROLIS、XGEVA 和 Nplate，都創下了季度銷售紀錄。我們在美國以外的業務年增了 19%，銷量較去年同期成長了 25%。我們繼續執行以銷量為導向的成長策略，並看到業務正從疫情的影響中逐步復甦。第三季初，由於新冠肺炎病例激增，我們看到病患照護動態出現波動。隨著季度的推進，我們看到患者就診量和診斷率都有提高。第三季客戶整體活躍度有提升。然而，面對面的客戶互動仍然低於 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. Overall revenue for our general medicine portfolio grew 22% year-over-year with 24% volume growth. In bone health, Prolia sales grew 15% year-over-year, driven by double-digit volume growth. In the third quarter, new and repeat patient demand continued to improve as osteoporosis diagnosis rates reached over 90% of pre-COVID levels. EVENITY, which complements Prolia in our bone portfolio, had record sales of $149 million for the third quarter, driven by strong volume growth. Given the severe impact of fractures on the lives of postmenopausal women, EVENITY provides an excellent therapy to build bone first.

現在讓我來回顧一下一些產品詳情，首先是我們的普通藥品組合，其中包括 Prolia、EVENITY、Repatha 和 Aimovig。我們普通藥品組合的總收入年增 22%，銷量成長 24%。在骨骼健康領域，Prolia 的銷售額年增 15%，這主要得益於兩位數的銷售成長。第三季度，隨著骨質疏鬆症診斷率恢復到新冠疫情前水準的 90% 以上，新患者和復診患者的需求持續改善。EVENITY 是我們骨骼產品組合中 Prolia 的補充，在強勁的銷售成長推動下，第三季銷售額創下 1.49 億美元的紀錄。鑑於骨折對停經後婦女的生活造成了嚴重影響，EVENITY 提供了一種極佳的療法，可以先重建骨骼。

Moving to Repatha, which remains the global leader in the PCSK9 class. Repatha sales increased 33% year-over-year, driven by 42% volume growth. In the U.S., we saw 64% year-over-year volume growth. 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. Outside the U.S., volumes grew 24% year-over-year. We remain confident in our ability to grow Repatha globally to address the significant unmet medical need in treating high-risk cardiovascular patients.

轉而使用瑞百艾（Repatha），該公司仍然是 PCSK9 類藥物領域的全球領導者。瑞百安銷售額年增 33%，其中銷量成長 42%。在美國，我們看到銷量年增了 64%。由於越來越多的 Medicare Part D 患者接受 Repatha 治療並進入了「甜甜圈漏洞」（doughnut hole，指醫療保險 D 部分）期，導致淨售價下降，部分抵消了上述影響。美國以外地區的銷量較去年同期成長 24%。我們仍有信心在全球發展 Repatha，以滿足治療高風險心血管疾病患者方面尚未滿足的重大醫療需求。

Moving to our inflammation portfolio, Otezla sales increased 13% year-over-year with 7% volume growth. Since its launch, Otezla has been used by over 750,000 patients globally. And in the U.S., it is the leader in bio-naive psoriasis patient share. Otezla has 92% commercial payer coverage and is an affordable, safe and efficacious option for psoriasis and psoriatic arthritis patients. 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. Enbrel sales decreased 3% year-over-year, driven by a 2% decline in volume. This is the second straight quarter of slowing volume declines, thanks to Enbrel's long track record of efficacy and safety.

再來看我們的發炎產品組合，Otezla 的銷售額年增 13%，銷量成長 7%。自上市以來，Otezla 已在全球被超過 75 萬名患者使用。在美國，它在生物製劑初治銀屑病患者群體中佔據領先地位。Otezla 的商業保險覆蓋率高達 92%，對於乾癬和乾癬性關節炎患者來說，它是一種價格合理、安全有效的選擇。我們現在正為預計在第四季度獲得美國批准用於治療輕度至中度銀屑病做準備，屆時我們將首次有機會推廣 Otezla 在該患者群體中的應用。受銷量下降 2% 的影響，恩利（Enbrel）的銷售額較去年同期下降了 3%。由於恩利（Enbrel）長期以來療效和安全性良好，這是其銷量連續第二季下降速度放緩。

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. Our sales force is fully staffed, trained and has been deployed to provide disease state education. We are actively engaging with payers to ensure access to patients for this breakthrough medicine. We look forward to bringing tezepelumab to the 2.5 million people around the world who live with severe uncontrolled asthma.

我們正與合作夥伴阿斯特捷利康一起，為 tezepelumab 在美國的上市做準備，預計 PDUFA 日期為 2022 年第一季初。我們的銷售團隊人員配備齊全，訓練有素，並已部署到位，以提供疾病狀態教育。我們正積極與支付方溝通，以確保患者能夠獲得這種突破性藥物。我們期待著將tezepelumab帶給全世界250萬患有嚴重未控制氣喘的患者。

Moving to the hematology and oncology business. 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. Several brands had record sales in the quarter, including XGEVA, KYPROLIS, Nplate, and BLINCYTO. Neulasta Onpro maintained 50% volume share in the quarter and continues to be the preferred choice for physicians and patients. The most recent published average selling price for Neulasta in the U.S. declined 38% year-over-year and 10% quarter-over-quarter. Going forward, we expect increased competition to result in continued net price and volume erosion.

轉戰血液腫瘤領域。本季，我們6款創新產品以及MVASI和KANJINTI生物相似藥的銷售額總計達18億美元，較去年同期成長12%。本季多個品牌的銷售額創下歷史新高，其中包括 XGEVA、KYPROLIS、Nplate 和 BLINCYTO。Neulasta Onpro 在本季度保持了 50% 的市場份額，並且仍然是醫生和患者的首選。美國最新公佈的 Neulasta 平均售價年減 38%，較上季下降 10%。展望未來，我們預期競爭加劇將導致淨價和銷售持續下滑。

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. LUMAKRAS has been prescribed by over 500 oncologists in both academic and community settings. 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. 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. Outside the U.S., health authorities have also approved LUMAKRAS in Canada and LUMAKRAS in the U.K.

LUMAKRAS 的上市取得了強勁的開局，第三季收入達 3,600 萬美元，截至第三季末累計銷售額達 4,500 萬美元。LUMAKRAS 已被 500 多位腫瘤科醫生在學術和社區機構中開立處方。大多數臨床實驗室已更新其檢測報告，將 KRAS G12C 反映為可採取行動的突變，目前約有 75% 的非小細胞肺癌患者在確診時接受該突變的檢測。在我職業生涯中參與過多次肺癌藥物上市，我對LUMAKRAS在美國的上市非常滿意。這要歸功於我們廣泛的醫保覆蓋範圍以及腫瘤學界的正面迴響。在美國以外，加拿大和英國的衛生部門也已批准使用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. And with that, I'll turn it to Peter.

總的來說，我對本季的業績感到滿意，我們多款產品的銷售額都創下了歷史新高，客戶活躍度也不斷提高。接下來，我將把麥克風交給彼得。

Thank you, Murdo. I will briefly walk through our third quarter financial results before discussing 2021 guidance. 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.

謝謝你，默多。在討論 2021 年業績展望之前，我將簡要回顧我們第三季的財務表現。在過去18個月充滿挑戰的時期裡，我們團隊的執行力持續增強，使我們有信心及時做出審慎的投資，無論是在內部創新還是外部創新方面，都能實現長期成長。

Let's now turn to the business. The third quarter marked another period of solid performance with year-over-year revenue growth of 4% and non-GAAP EPS growth of 11%. As Murdo described, strong volume growth continued in the quarter with 8% year-over-year growth driven by Prolia, EVENITY, Repatha and MVASI. In addition, this quarter includes $147 million of favorable changes to estimated sales deductions previously recorded. 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.

現在讓我們來談談正事。第三季業績表現依然穩健，營收年增 4%，非 GAAP 每股盈餘成長 11%。正如 Murdo 所描述的那樣，本季度銷量繼續強勁增長，同比增長 8%，這主要得益於 Prolia、EVENITY、Repatha 和 MVASI 的推動。此外，本季還包括先前記錄的估計銷售扣除額的 1.47 億美元有利變動。去年第三季度，有利的預計銷售額扣除額為 3,600 萬美元，導致本季年增 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. These products will continue to contribute meaningful cash flows to our broader portfolio and also to innovation. We do expect increased competition to result in additional erosion of these established products.

由於銷售下降和淨售價降低，我們成熟的產品（包括 Neulasta、NEUPOGEN、EPOGEN、Aranesp、Parsabiv 和 Sensipar）同比下降了 21%。這些產品將繼續為我們更廣泛的產品組合以及創新貢獻可觀的現金流。我們預計日益激烈的競爭將導致這些成熟產品的市場份額進一步下降。

Other revenues at $386 million increased 21% year-over-year primarily driven by shipments of the COVID-19 antibody therapy to Lilly. We expect full year 2021 other revenues to be in a range of $1.5 billion to $1.7 billion.

其他收入為 3.86 億美元，年增 21%，主要得益於向禮來公司交付 COVID-19 抗體療法。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. 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. We will continue to execute on opportunities to allocate capital to important internal and external innovation opportunities.

第三季非GAAP營運總支出與去年同期持平，這得益於公司持續專注於執行、生產力和效率，從而推動了長期增長的投資，其中包括與Rodeo、Five Prime和Teneobio收購以及與Kyowa Kirin合作相關的全年約2億美元運營支出的第三季度份額。透過嚴格的費用控制，我們現在預計全年營運費用絕對值將比去年增長約 3% 至 4%，其中包括與這些交易相關的約 2 億美元。我們將繼續把握機會，將資金配置到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. For the full year, we continue to expect cost of sales as a percent of product sales to be 16% to 17%. Non-GAAP R&D spend in the quarter decreased 4% year-over-year. 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.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比較去年同期上升1.5個百分點至15.8%，主要原因是產品組合的變化，包括向禮來公司交付COVID-19抗體。我們預計全年銷售成本佔產品銷售額的百分比仍為 16% 至 17%。本季非GAAP研發支出較去年同期下降4%。預計全年非GAAP研發支出將以中等個位數百分比成長，因為我們將推動創新研發管線項目，包括啟動肺癌和胃癌的註冊試驗。

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. 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. We expect full year net expense in the range of $1.3 billion to $1.4 billion. We have financial flexibility with $12.9 billion in cash and investments on our balance sheet and strong cash flows. Additionally, our third quarter dividend was $1.76 per share, an increase of 10% over last year.

本季非GAAP SG&A費用下降了5%，我們預計全年也將下降，因為我們將繼續專注於提高執行效率和數位化。非GAAP其他收入和支出淨支出較去年同期增加，原因是我們在百濟神州20%的業績份額下，按權益法提列的虧損增加，且該虧損已滯後一個季度。我們預計全年淨支出將在 13 億美元至 14 億美元之間。我們擁有129億美元的現金和投資，資產負債表上現金及投資金額充足，現金流強勁，財務狀況靈活。此外，我們第三季的股息為每股 1.76 美元，比去年增長了 10%。

Turning to the outlook for the business for 2021. 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. Moving to revenue. Based on underlying market dynamics, we are updating our 2021 revenue guidance range to $25.8 billion to $26.2 billion. We are increasing our non-GAAP EPS guidance range to $16.50 to $17.10. Our non-GAAP tax rate range is updated to 13.0% to 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. We expect share repurchases for 2021 to be in the upper end of our range of $3 billion to $5 billion. We executed effectively in the third quarter and are well positioned for long-term growth.

接下來展望一下公司2021年的業務前景。我們已投資於內部和外部創新，以推進我們在 2021 年的產品線，並繼續為長期成長奠定良好基礎。轉向營收。根據潛在的市場動態，我們將 2021 年營收預期範圍更新為 258 億美元至 262 億美元。我們將非GAAP每股盈餘預期範圍上調至16.50美元至17.10美元。我們的非GAAP稅率範圍更新為13.0%至14.0%。我們的資本支出指導目標仍為 9 億美元，我們的資本支出將繼續包括支持我們環境活動的投資，以及支持我們實現碳中和的承諾。我們預計 2021 年的股票回購規模將達到我們預期的 30 億美元至 50 億美元區間的上限。我們在第三季執行得非常有效，為長期成長做好了充分準備。

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. Bob?

在將發言權交給鮑伯之前，我想感謝並表彰安進公司遍布全球的 24,000 名同事，感謝他們又一個季度取得了強勁的業績。鮑伯？

Okay. Thank you, Peter. Why don't we open up the call now for questions. And let's remind our callers of the procedures and the request that we limit our questions to just one on the first go. Thanks.

好的。謝謝你，彼得。現在我們開始接受提問吧。我們也要提醒來電者一些注意事項，並請求大家第一次來電時只提一個問題。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 的線路。

Just a question about the financials and how to think about go forward, that's sort of a high-level question. 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. How do you think about the push and pull dynamics as we enter 2022? I know you don't give 2022 guidance. So I would just love you to comment on the high level, realizing we're in a pandemic.

關於財務狀況以及未來發展方向的問題，這是一個比較宏觀的問題。但考慮到今年的業績，以及今年業績指引的收窄，這家公司通常都能取得較高的業績，而且我知道目前新冠疫情仍在持續。您如何看待我們進入 2022 年後出現的推拉動態？我知道你們不提供 2022 年的指導。所以，我希望您能從宏觀層面發表一些看法，畢竟我們正處於疫情大流行之中。

Yes, Michael, you're right. We're not going to give 2022 guidance at this point. 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. 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.

是的，邁克爾，你說得對。目前我們不打算提供 2022 年的業績指引。我認為大家可以看到，我們繼續有效地管理業務，這體現在營收成長 4% 和淨利每股收益成長 11% 上，我們將繼續投資於我們認為能夠帶來成長的機會。我們非常清楚，展望未來，我們期望能夠為股東帶來成長，我們將在發布下一階段業績指引時對此進行更詳細的說明。

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

你的下一個問題來自美國銀行的傑夫‧米查姆。

It's Aspen on for Geoff. So you previously talked about that over 3,000 patient number treated with LUMAKRAS that includes some patients on studies. I guess I just want to get a sense of what percentage of that maybe the nonpaying bolus has been converted over to paying? And I mean what's the time line for moving through the rest of them is?

傑夫要去阿斯彭了。所以你之前提到過，有超過 3000 名患者接受了 LUMAKRAS 治療，其中包括一些參與研究的患者。我只是想了解一下，那些原本不付費的注射劑中，有多少比例已經轉為付費注射？我的意思是，完成剩下的任務需要多長時間？

It's Murdo. Thanks for the question. We are roughly at about 75% of early access programs or patients who were enrolled in clinical trials converting to commercial supply. 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. 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.

是默多。謝謝你的提問。目前，早期准入計畫或參與臨床試驗的患者中，約有 75% 的人正在轉為商業化用藥。目前這種情況主要發生在美國和法國這兩個主要市場，而我們尚未在歐洲獲得批准。我們確實可以參與法國的 ATU 項目，從我們的早期准入項目出來的患者可以轉入 ATU 項目，我們實際上可以從中獲得收入。

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

你的下一個問題來自克里斯·雷蒙德和派珀·桑德勒的對話。

I got a question on Aimovig or maybe more strategically your neurology presence. 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. Murdo, I kind of noticed that you sort of skipped over that one in the prepared comments. Maybe just sort of talk about your commitment to neurology now with this market dynamic. Is this a category that we should expect more investment in from a product offering standpoint? Is there may be some other plan here that you could maybe talk about?

我有一個關於 Aimovig 的問題，或者更確切地說，是關於您在神經學領域的影響力的問題。所以就藥物本身而言，很明顯，收入和處方趨勢已經停滯不前，我認為很明顯，口服 CGRP 正在對市場產生影響。Murdo，我注意到你在準備好的評論中似乎略過了那一點。或許可以談談在當前市場情勢下，您對神經病學的投入。從產品供應的角度來看，我們是否應該預期在這個領域投入更多資金？這裡是否還有其他方案可以和您談談？

Sure. Thanks, Chris. 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. 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. And even the preventative setting has grown with the advent of the oral. So we expect that the market still has quite a bit of growth and headroom for growth. We expect to be able to continue to maintain our leadership share position in total prescriptions. We have over 5 years now of safety and efficacy data in the market. We continue now to have all of the U.S. commercial responsibility for Aimovig given recent work to consolidate what Novartis was previously contributing. So we've actually increased our neurology presence in the last few months.

當然。謝謝你，克里斯。首先我想說的是，Aimovig 仍然是幫助偏頭痛患者的重要產品，我們仍然相信，CGRP 類藥物的出現尚未幫助到大量的偏頭痛患者。顯然，作為 CGRP 皮下注射產品的市場領導者，隨著口服藥物進入市場，我們失去了市場份額，但口服藥物也把市場從預防領域擴展到了急性治療領域。隨著口腔技術的出現，預防性措施也得到了發展。因此，我們預期市場仍有相當大的成長空間。我們預計能夠繼續保持我們在處方總量方面的領先市場份額。我們目前已有超過5年的市場安全性和有效性數據。鑑於我們最近的工作，整合了諾華公司先前所貢獻的業務，我們現在繼續承擔 Aimovig 在美國的所有商業責任。因此，在過去的幾個月裡，我們實際上增加了神經科的投入。

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. So a bit of headroom. 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.

最後，我們感到興奮的是，我們正在等待與托吡酯進行直接比較的優效性數據公佈，之後我們將能夠向普通神經科醫生、頭痛專家，甚至許多使用 Aimovig 來幫助慢性偏頭痛患者的初級保健醫生推廣這些數據。所以還有一些迴旋餘地。你說得對，口服藥物的普及確實會減少一些成長，而且本季淨價的上漲也會減少一些成長。

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.

從策略角度來看，我們將繼續尋找與我們正在打造的特許經營體系相契合的產品，我們將繼續尋找這些產品。

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

你的下一個問題來自 Umer Raffat 與 Evercore ISI 的對話。

I feel like Amgen went through this period of getting a fair amount of credit for the clinical development and LUMAKRAS program. 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. And I guess my question is, what's your base case on how sort of the clinical data across the field shakes out? Is this going to be a PD-1 like situation or everybody about the same? Or could you end up seeing approaches like RAS(ON) inhibitors, et cetera, look any different on resistance mutations. 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?

我覺得安進公司在這段時間裡，憑藉其臨床開發和 LUMAKRAS 專案獲得了相當多的讚譽。我們可能正進入這樣一個階段：許多競爭對手都有針對 KRAS 的臨床階段項目，並且將在未來幾個月內獲得大量數據。我想問的是，您認為該領域臨床數據的基本狀況如何？這會像《殺出重圍1》嗎？還是大家都差不多？或者，像 RAS(ON) 抑制劑等方法在抗藥性突變方面是否會有不同的表現？此外，我想補充一點，既然我們首先要考慮安進在 KRAS 標靶領域的領導地位，那麼我們是否應該期待安進針對其他 KRAS 突變（如 G12D 或 G12V）提交 IND 申請呢？

Thanks, Umer. This is Dave. As you mentioned, of course, there are multiple competitors coming behind LUMAKRAS. We feel very good about our position. I've not seen anything to tell us that we don't have a really outstanding molecule. And many of those are very, very early, just starting dose escalation. So I think it's premature to speculate on potential differentiated mechanism of action or these sorts of things.

謝謝你，烏默。這是戴夫。正如您所提到的，LUMAKRAS 背後當然還有許多競爭對手。我們對自己的處境感到非常滿意。我還沒有看到任何證據表明我們沒有真正傑出的分子。其中許多研究還處於非常非常早期的階段，才剛開始劑量遞增。所以我認為現在就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. As we've mentioned, we're now under regulatory review. 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. So I feel very good about where we are. We've got a large combination therapy program. There's lots to learn yet. 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.

我們還擁有一個覆蓋面非常廣的全球項目。正如我們之前提到的，我們目前正在接受監管審查。據我最新統計，目前該服務已涵蓋超過 15 個司法管轄區或國家，包括歐洲藥品管理局 (EMA) 和日本，這兩個國家的審查工作正在進行中，當然，這兩個市場都非常大。所以我對我們目前的狀況感到非常滿意。我們有一個大型的聯合治療計畫。還有很多東西要學。從研發到進入臨床應用花了 40 年時間，我們還在研究很多生物學問題，但我對我們目前擁有的分子以及我們所取得的成就感到非常滿意。

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

Dave，還有什麼想補充的嗎？關於我們的 G12D 或 V 程式？

Sorry. Thanks for the reminder. In terms of -- we are interested in other targets. 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. We do have some work ongoing. And as that progresses, we will say more about that publicly.

對不起。謝謝提醒。至於──我們對其他目標也感興趣。正如你們許多人所知，目前有 7 或 8 種特定的 KRAS 突變可能具有吸引力，儘管它們在結構上各不相同，每一種都帶來了不同的挑戰。我們目前有一些工作正在進行中。隨著事態發展，我們將公開更多相關資訊。

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

你的下一個問題來自 Yaron Werber 與 Cowen 的合作系列。

This is Gabe on for Yaron. Just for LUMAKRAS to follow up. 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? Will we have TPS status available for all patients? And then just for the second SHP2 combination arm that you recently added. Any insight you could share into the thinking behind adding TNO155? Was there any difference in the profile compared to the RevMed molecule that you would highlight that might be a better overlap with LUMAKRAS?

這是 Gabe 代替 Yaron 發言。僅供 LUMAKRAS 跟進。對於預計明年上半年公佈的帕博利珠單抗（pembro）數據，您能否給我們介紹一下，這些數據是否足夠成熟，可以讓我們更了解其療效？所有患者都能查詢到TPS狀態嗎？然後，就針對您最近新增的第二個 SHP2 組合手臂而言。您能否分享一下添加TNO155背後的考量？與 RevMed 分子相比，該分子的譜圖是否有任何差異，您認為哪些差異可能與 LUMAKRAS 有更好的重疊性？

Yes. Thanks, Gabe. 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. 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. And so we're pressing forward on all fronts. Thank you.

是的。謝謝你，蓋布。是的，就——我概括地說——檢查點抑制劑組合數據而言，我們預計在明年上半年某個時候，當我們把所有數據收集起來並公佈時，我們將擁有足夠完整的數據集，我認為，這將為該領域提供關於這些組合的良好見解。就我們正在研究的各種 SHP2 抑制劑的組合而言，這些藥物之間存在一些生化差異，考慮到 SHP2 作為組合標靶的潛在重要性和機制原理，我認為研究這些不同的分子是值得的。因此，我們正在各方面全力推進。謝謝。

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

你的下一個問題來自 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. And particularly, could you give us a sense of what the financial impact on Amgen would be of the proposed Part D changes? 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?

鮑伯和默多，或許我可以再問一個稍微宏觀的問題。我知道你們密切關注華盛頓特區發生的事情。我很想知道，你們認為我們是否即將就藥品定價改革達成協議。具體來說，您能否簡要說明一下擬議的D部分變更將對安進公司的財務狀況產生怎樣的影響？其次，您是否認為您有任何分子可以根據擬議的聯邦談判與 B 部分（按當前措辭而言，是選定的 B 部分藥物）進行談判？

Yes. Thanks, Geoff. It's obviously very premature for anybody to pretend like they know what the shape of the new legislation will be. I don't think anybody has really seen any meaningful draft language yet. 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. So we'll need to wait and see the details. 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. So stay tuned, Geoff, again, very premature. 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.

是的。謝謝你，傑夫。顯然，現在就妄下斷言自己知道新法案的走向還為時過早。我認為目前還沒有人真正看到任何有意義的草案文本。當然，我們注意到，眾議院和參議院之間有一些推特互動和來回交流，包括雙方的溫和派人士都表示，他們已經接近達成一致，並且認為他們有一個可以圍繞其達成共識的框架。所以我們需要拭目以待，看看具體情況如何。不出所料，我們將重點關注他們提出的方案是否能讓患者更好地獲得藥物，以及在實現這一目標的同時，是否能維護讓我們所有人能夠以我們目前的方式以及我們認為對國家而言必要的方式進行創新的生態系統。所以，傑夫，敬請期待，但現在說這些還為時過早。我知道你們都想畫一張可以和投資者分享的圖片，一張有意義的圖片，但我認為現在任何人試圖畫出這樣的圖片，實際上都是在用雕塑的方式描繪霧氣。

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

你的下一個問題來自摩根士丹利的馬修·哈里森。

I was wondering if we could just touch a little bit on your outlook for product guidance. It looks like you raised other revenue guidance, but you also took down the high end of your total company guidance. So maybe you could just talk about -- and that looks like about a $800 million swing if you add the 2 together. So maybe you could just talk about what's the driver there and where you're seeing the pressure.

我想問一下，我們能否稍微談談您對產品指導的看法？看來你們提高了其他方面的營收預期，但同時也下調了公司整體營收預期的上限。所以也許你可以談談——如果把這兩個加起來，看起來金額會相差大約 8 億美元。所以，或許你可以談談那裡的驅動因素是什麼，以及你在哪裡看到了壓力。

Matthew, thank you, Peter here. Listen, on the revenue range, we're $25.8 billion to $26.2 billion reflects the latest market dynamics, as Murdo shared with you. 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. 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. So we continue to build into guidance, mid-single-digit net price declines in '21. We've got other revenue at $1.5 billion to $1.7 billion. The increase year-over-year driven primarily by the Lilly manufacturing reimbursement profit share, which began in the second quarter, as we've said. And so those are the dynamics around the top side of the guidance.

馬修，謝謝你，我是彼得。聽著，關於營收範圍，我們預計為 258 億美元至 262 億美元，這反映了最新的市場動態，正如 Murdo 向你分享的那樣。正如我之前提到的，Prolia、Otezla、Repatha、EVENITY 生物相似藥等產品的銷售量逐年增長，與成熟產品的競爭也帶來了巨大的現金流，但這對我們來說是一個重要的現金流來源。你看，我們之前預期的更強勁的復甦並沒有以我們預測的速度實現，但正如默多向你描述的那樣，復甦仍在以穩定但更緩慢的速度繼續進行。因此，我們繼續在業績指引中預測，2021 年淨價格將出現中個位數的下降。我們還有其他收入，金額在 15 億美元到 17 億美元之間。正如我們之前所說，年成長主要得益於禮來公司從第二季開始的藥品生產報銷利潤分成。以上就是指導意見頂部的相關動態。

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. 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. So I don't think we're experiencing anything different from our peers. 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. But again, otherwise, business is performing well and consistent with where we hope to end the year.

馬特，我只想指出，相對於年初我們給出最初指導意見時的情況，新冠疫情的影響持續時間比我們年初預想的要長，尤其是在面對面就診和醫生辦公室內的患者診斷數量方面。因此，從回顧的角度來看，很明顯，這次激增對去看醫生的患者人數以及處方開具量都產生了影響。所以我覺得我們遇到的情況和同儕沒什麼不同。但在年初的時候，我們曾經滿懷希望，認為疫苗和其他措施或許能讓我們——使我們能夠比現在走得更遠，從而告別這場疫情。但除此之外，業務表現良好，與我們希望在年底達到的目標一致。

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

你的下一個問題來自阿萊西亞·楊和坎托·菲茨杰拉德的血脈。

Maybe to follow up a little bit along with that. Can you just talk a little bit about it like Repatha and Aimovig, some of the selling price pressure are you seeing? And do you think that it's kind of a kind of a slow step down? Or is it kind of something that just we're having more periodically?

或許可以稍微補充一下。您能否簡單談談像Repatha和Aimovig這樣的藥物，您觀察到的銷售價格壓力是什麼？你覺得這是一種緩慢的衰退過程嗎？或者這只是我們週期性遇到的情況比較多而已？

Alethia, did you say Repatha and Aimovig. Is that what you're asking?

Alethia，你剛剛說的是Repatha和Aimovig嗎？你問的是這個嗎？

Yes. Yes.

是的。是的。

Yes. Okay, sure. 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. So we've seen some really nice growth there. But what happens when you grow in Medicare Part D is you also grow in the number of patients that enter the donut hole. And that's what we're really seeing in Q3, and we expect that to continue in Q4. The good news side of that equation is we're growing nicely in Medicare. 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. But I would expect a pattern of Q3 and Q4 net price drag as a function of the Medicare Part D coverage gap. Unless, of course, that changes in whatever is brewing in D.C. but that's how it's happened right now.

是的。好的，沒問題。因此，本季 Repatha 的業績更取決於我們自降低價格以來在提高 Medicare Part D 人群滲透率方面所取得的成就。所以我們看到那方面確實取得了不錯的成長。但是，隨著 Medicare Part D 的覆蓋範圍擴大，進入「甜甜圈漏洞」（自付額上限）的患者人數也會增加。這就是我們在第三季實際看到的情況，我們預計這種情況將在第四季繼續下去。好消息是，我們在聯邦醫療保險領域發展勢頭良好。我們看到，Medicare 的患者棄醫現像大大減少，這應該會成為我們未來持續成長的動力。但我預計第三季和第四季淨價格將出現下滑，這是由於醫療保險D部分覆蓋缺口造成的。當然，除非華盛頓特區正在醞釀的事情發生了改變，但目前的情況就是這樣。

On Aimovig, it's a little bit different. It's just -- it's really the annualization of contracted business with PBMs in general. There's been fairly competitive activity there to maintain preferred formulary positions on national PBMs. And we don't have the same amount of volume growth on Aimovig, but we do expect that to be more stable going forward. 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.

在 Aimovig 上，情況略有不同。這只是——這實際上是與藥品福利管理機構 (PBM) 簽訂的年度合約業務的普遍化。為了保住國家藥品福利管理機構（PBM）的優先處方集地位，競爭相當激烈。Aimovig 的銷售成長雖然沒有達到同樣的水平，但我們預計未來會更加穩定。所以總的來說，我認為主要的價格影響已經穩定下來，而且我們現在確實看到成交量大幅下降。

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

你的下一個問題來自 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? 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?

您能否透露一下olpasiran II期研究的入組進度？另外，您能否分享一下您對脂蛋白 A 市場競爭格局演變的看法，特別是考慮到 pelacarsen 有可能在 olpasiran 之前獲得批准？

Yes. Thanks, Jay. Yes, in terms of the Phase II study, it is actually completed enrollment. So of course, these patients are followed for some time. And as I noted in my remarks, we expect data in the middle of 2022. 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. So that program is on track or if anything, a little ahead of schedule.

是的。謝謝你，傑伊。是的，就二期研究而言，實際上已經完成了受試者招募。所以，這些患者當然要接受一段時間的追蹤。正如我在演講中提到的，我們預計將在 2022 年年中獲得數據。我們對 I 期試驗的長期追蹤結果非常滿意，該試驗顯示 Lp(a) 降低，且該分子具有初步的安全性。所以這個專案進展順利，甚至可能還略微超前了一些。

As you know, there is another molecule ahead of us. We have a slightly different mechanism as a small interfering RNA. We like the molecule quite a bit. This is a large population of patients. Recall that about 50% of atherosclerotic cardiovascular disease is not driven by LDL-cholesterol and probably the majority of that is Lp(a) driven. So we believe there are many, many patients around the world that can be served by Lp(a) lowering agents. And so we're quite eager to see the full Phase IIb data.

如你所知，我們前面還有另一種分子。我們採用的是一種略有不同的機制，即小幹擾RNA。我們非常喜歡這個分子。這是一個龐大的患者群體。請記住，約 50% 的動脈粥狀硬化性心血管疾病並非由 LDL 膽固醇引起，其中大部分可能由 Lp(a) 引起。因此我們相信，世界各地有很多很多患者可以透過降低 Lp(a) 水平的藥物來治療。因此，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.

你的下一個問題來自 Ronny Gal 與 Bernstein 的對話。

So we typically asked you about the negative impact of a potential deal in Washington. I was wondering if we can reverse it and talk about the benefits. 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? What are the drugs where you see significant abandonment in Medicare Part D that might take or might get more use? And second, you started interchangeability trial for HUMIRA biosimilars. Can you just talk a little bit about your change your perspective here? Do you believe that interchangeability will be required longer term to participate in this market? And if not, what's the justification for the trial?

所以我們通常會問你，在華盛頓達成潛在協議會帶來哪些負面影響。我在想我們能不能反過來談談好處。因此，如果達成任何限制患者自付費用的協議，哪些藥物會因使用量增加而受益？在聯邦醫療保險D部分中，哪些藥物的使用率明顯偏低，但未來可能會提高或增加使用率？其次，你們啟動了 HUMIRA 生物相似藥的互換性試驗。您能稍微談談您是如何改變看法的嗎？你認為從長遠來看，互換性對於參與這個市場是否必不可少？如果不是，那麼審判的理由是什麼？

Thanks, Ronny. It's Murdo. 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. 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. So I think products like Repatha, where we are largely a Medicare Part D population, could benefit from out-of-pocket caps. Now it would depend obviously, what that travels with. Does it travel with more commitment from the manufacturer in the catastrophic phase, where we pick up more of the tab. So it needs to be equated with other things that could be in any proposed legislation. 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.

謝謝你，羅尼。是默多。所以，假設立法有所改變，對D部分患者引入自付費用上限，我認為這將對我們的投資組合有所幫助。我們一直倡導對 D 部分進行這方面的改革，我們認為，降低患者的自付費用和共同支付的價格等式，可以減少患者對藥物依從性的不利因素，甚至可能影響首次配藥。所以我認為像 Repatha 這樣的產品，由於我們的目標群體主要是參加 Medicare Part D 的人群，可能會受益於自付費用上限。當然，這取決於它和什麼一起運輸。在災難性階段，製造商是否會承擔更多責任，讓我們承擔更多費用？因此，需要將其與任何擬議立法中可能包含的其他內容進行類比。但我希望自付費用上限能夠發揮作用，因為我認為參加 D 部分計劃的患者有時會因此受到不公平的對待，無法獲得最佳治療，而自付費用上限可以提高他們的經濟承受能力。

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

關於 AMGEVITA 互換性研究的問題，我們仍然對 AMGEVITA 的發展前景感到非常樂觀。作為美國 HUMIRA 生物相似藥的首批上市者之一，並且有可能成為首批上市的唯一一家，這讓我們有機會與支付方、藥品福利管理機構 (PBM) 和醫療服務提供者合作，從而確立領先地位。我們會仔細研究生物相似藥的每一個參數，這不僅體現在歐洲 AMGEVITA 本身的經驗中，也體現在美國其他生物相似藥產品組合的經驗中。我們會考慮諸如不含乳膠、不含檸檬酸鹽、針頭規格、器械等因素，當然，我們也會考慮互換性。因此，雖然我們認為它並非必不可少，但我們認為這只是產品的另一個特性，可以增強我們在 2023 年發佈時的成功率。所以，這就是我們發起審判的真正原因，羅尼。

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

你的下一個問題來自加拿大皇家銀行資本市場的 Kennen MacKay。

This is Sudan Loganathan on for Kennen. So first, I wanted to ask on LUMAKRAS. So how much of an impact are you expecting LUMAKRAS having on the updated top end revenue guidance that you updated for 2021? 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?

我是蘇丹‧洛加納森 (Sudan Loganathan)，代表凱南 (Kennen) 發言。首先，我想問一下關於LUMAKRAS的問題。那麼，您預計 LUMAKRAS 對您更新後的 2021 年高階營收預期會產生多大的影響？考慮到 2022 年可能進入市場的競爭對手，您計劃如何據此制定 2022 年的收入預期？

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

其次，關於 LUMAKRAS 聯合 Vectibix 三線聯合療法治療結直腸癌，展望未來，如果獲得批准，這對 Vectibix 意味著什麼？如果這項組合方案獲得批准，我們能否期待該專案有所成長？

And then thirdly, just wanted to mention -- ask about the antibody manufacturing agreement with -- for Eli Lilly in COVID-19. Is that still something we can expect to be included in the other revenue line item going forward? And any update on that just based on the pandemic environment?

第三，我想提一下──詢問一下與禮來公司在新冠肺炎抗體生產方面的協議。未來這部分收入是否仍會包含在其他收入項目中？基於疫情情勢，這方面有最新進展嗎？

Yes. Let's take the first question, and we can answer that. And the rest -- call me later, this is Arvind from Investor Relations, and we can address those questions separately. So Dave, maybe you can address the question about LUMAKRAS.

是的。我們先來看第一個問題，我們可以回答這個問題。至於其他問題——請稍後再聯絡我，我是投資人關係部門的 Arvind，我們可以另行解答。所以戴夫，或許你可以回答一下關於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. So we obviously don't provide product level revenue guidance. But I'll say this. I've worked in oncology for many years now, and I've been a part of some important lung cancer product launches. And this launch after 40 years of trying to solve the KRAS G12C conundrum in lung cancer, this launch has been very special. And the team has done an excellent job of executing across the payer customers, our provider customers and of course, for patients. 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. And so far, it's early days, but so far, they've done very, very well. And so I'm pleased with the trajectory.

是的，這更像是商業問題。因此，我們顯然不提供產品層面的收入預測。但我還是要說一句。我從事腫瘤學工作多年，並參與一些重要的肺癌產品上市。經過 40 年的努力，終於解決了肺癌中的 KRAS G12C 難題，這次的發布意義非凡。團隊在服務支付方客戶、醫療服務提供方客戶以及患者方面都做得非常出色。我為我們研發部門所取得的成就以及他們迅速將這款產品推向市場感到非常自豪。我覺得醫療和商業部門都非常認真負責地對待這次產品上市的客戶階段和市場推廣階段。雖然現在下結論還為時過早，但到目前為止，他們做得非常非常好。因此，我對目前的發展軌跡感到滿意。

What we're seeing is many academic centers are changing their testing protocols in lung cancer so that everybody knows their KRAS G12C status. Many large community oncology networks have done the same. Now we still have a few large community oncology networks to go. 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. 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.

我們看到，許多學術中心正在改變肺癌的檢測方案，以便每個人都能知道自己的 KRAS G12C 狀態。許多大型社區腫瘤網絡也採取了同樣的做法。現在我們還有幾個大型社區腫瘤網絡要建立。所以我們將在第四季度著手處理這些問題，但我對我們進入市場的方式感到非常滿意。我認為這預示著我們有能力確立強大的領導地位，並在競爭對手進入市場之前幫助許多不幸從一線治療發展到二線治療的患者。

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. And the drug is working well in the marketplace. 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.

推出這樣一款產品，你會聽到這樣的故事：一些患者被告知他們的選擇有限，應該接受臨終關懷，但他們離開臨終關懷機構後，接受了 LUMAKRAS 和商業藥物的治療，並且取得了療效。這種藥物在市場上表現良好。我們從處方醫生那裡聽到了許多類似的軼事，我們將繼續盡一切努力在全球範圍內快速推出 LUMAKRAS，幫助更多的患者。

Great. Thanks, Murdo. Erica, let's take the next question, please.

偉大的。謝謝你，默多。艾麗卡，我們來回答下一個問題吧。

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

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

Maybe a glass half empty one and a glass half full one. I'll start off with the glass half empty. 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. 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. 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. 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. Can you talk a little bit about marketing strategy? You could have competition here, but you could stay ahead of that competition with all the drugs that you're developing. 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?

或許可以把杯子看成半空的和半滿的。我先從悲觀的角度來談談。所以，當我審視貴公司目前的經營狀況時，我的意思是，我認為我們在電話會議中多次聽到的是價格壓力，儘管貴公司取得了增長，並且擁有出色的營銷策略。然後，你會發現這條產品線有很多競爭對手，因為市場上有許多擁有類似分子或競爭分子的公司。所以對於這個問題，關鍵在於如何——任何藥物開發所需的工具包或平台，在開發和選擇下一代研發候選藥物方面，策略上的任何改變。然後，還有一個比較樂觀的問題是，你在肺癌領域擁有巨大的機會，或者說，你在 LUMAKRAS 藥物的研發方面做得非常出色。能簡單談談行銷策略嗎？這裡可能會有競爭，但你可以透過研發各種藥物來保持領先地位。請您詳細介紹一下，並提醒我們安進公司是如何確保即使在競爭激烈的市場環境中也能保持領先的？

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

或許我們可以反過來，默多，你先開始，然後戴夫再完成。

Well, not to belabor the point, but again, I've worked in the oncology field for a number of years. 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. We've augmented that recently with the launch of our biosimilar portfolio. And then most recently, of course, with the launch of LUMAKRAS. And when I sit down with CEOs of cancer networks or academic cancer centers, they are very interested in talking to Amgen. 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. So I think we are very much a leader in oncology.

好吧，我不想贅述，但我還是要再說一遍，我在腫瘤領域工作多年。自從我來到安進以來，我看到了安進悠久歷史的真正實力，這當然體現在我們對護理產品的支持上。我們最近推出了生物相似藥產品組合，進一步增強了這一優勢。當然，最近也推出了 LUMAKRAS。當我與癌症網絡或學術癌症中心的執行長坐下來交談時，他們都對與安進公司洽談非常感興趣。他們也有興趣與我們探討大衛·里斯及其研發同事正在開發的非常豐富的產品線。所以我認為我們在腫瘤學領域處於領先地位。

I think that our commercial position with innovative products and biosimilars and launches of new therapeutics puts us in a very strong account position. And I think in a world where a lot of care is delivered in community oncology, our relationships there are extremely strong. I've been able to make some customer visits this year despite some of the interruptions of the pandemic. And most of my visits have been in support of the LUMAKRAS launch. 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. And it's those systems and those processes that being first on the ground, we should be able to build and sustain. 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.

我認為，我們在創新產品、生物相似藥以及新療法的推出方面的商業地位，使我們在客戶關係方面處於非常有利的地位。我認為，在當今世界，許多護理工作都是在社區腫瘤科進行的，我們與社區腫瘤科的關係非常牢固。儘管受到疫情的一些幹擾，我今年還是能夠進行一些客戶拜訪。我的大部分訪問都是為了支援 LUMAKRAS 的發布。我可以告訴你們，他們在與我們合作開發測試程序、回顧程序、輸入標記和電子病歷以及確保患者被標記出來接受治療方面做得非常出色。而作為先行者，我們應該能夠建立和維持這些系統和流程。當然，從長遠來看，我們將繼續率先獲得適應症，並廣泛開發該資產，然後用戴夫正在我們研發管線中開發的肺癌相關產品來支持它。

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

謝謝你，羅賓。是的，就工具包而言，我們顯然可以花幾個小時來談論我們在探索性研究和臨床試驗中使用的工具包。為了方便討論，我只重點談談以下幾點。我們正在建立我認為是業界領先的人類數據能力，這意味著收集、整合和分析各種組學數據、基因組數據、轉錄組學數據、蛋白質組學數據，以及臨床試驗數據和真實世界數據中的真實世界證據。我們的核心信念之一是，未來幾十年將由那些懂得如何利用，尤其是如何分析現在正開始席捲我們的巨大數據海嘯的人贏得。

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

當然，這些數據可以用於產生藥物標靶和通路。正如我在準備好的演講稿中所提到的，我們正在建立開發多特異性分子的廣泛能力，無論是小分子、大分子或混合分子。目前已驗證的目標中，約有 80% 到 85% 無法用現有技術進行治療，我們正在建立相應的能力，以攻克我認為會對這些無法成藥的目標產生良好影響的靶點。所以我對我們已經建立並將繼續發展的平台感到非常滿意，未來一兩年內我們還會在這方面投入更多精力。

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

你的下一個問題來自摩根大通的科里·卡西莫夫。

This is Gavin on for Cory. Maybe one for Murdo. Just curious about the expected impact of Otezla's mild-to-moderate label expansion. Specifically, should we expect immediate uptick in 2022? Or is something that will be a little more gradual? 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. So just curious if that trend is going to continue?

這裡是加文替科里報道。或許可以給默多一個。我只是好奇 Otezla 輕度至中度的標籤擴張會帶來怎樣的預期影響。具體來說，我們是否應該預期 2022 年會出現立即回升？或者會是更循序漸進的過程？其次，地理擴張被強調為該產品成長的關鍵策略，世界其他地區的銷售額約佔總銷售額的 20%。所以，我只是好奇這個趨勢是否會持續下去？

Yes. Thank you, Gavin. 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. And obviously, we had to make a certain set of assumptions about how that product would evolve in our ownership. And so far, I have to say I'm even more pleased with the strength that the product brings to Amgen. 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.

是的。謝謝你，加文。在收購 Otezla 時，我認為它將極大地增強我們的產品組合以及我們在免疫學領域（包括皮膚病學和風濕病學）的優勢。顯然，我們必須對該產品在我們擁有期間的發展演變做出一些假設。到目前為止，我必須說，我對該產品為安進公司帶來的實力感到非常滿意。正如您所強調的，我們已經成功地證明了該產品在輕度至中度患者群體中的療效和安全性，考慮到該產品口服給藥的便利性以及其已充分證明的安全性和有效性，這對於該產品來說是一個完美的切入點。

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. And the fit is just perfect. We have integrated the legacy Celgene team fully into Amgen. We've got both Enbrel and Otezla now being promoted in rheumatology and dermatology. And we've seen volume growth improve in most markedly in the last part of Q3, but that continues into Q4. We didn't plan on a pandemic when we did the transaction, obviously, but we've weathered it well. The team is staying focused, and we are well prepared for the mild-to-moderate launch. We're anticipating a decision on that soon from the FDA. We have the resources available. We have the teams trained. We have an increased footprint in dermatology in anticipation of the approval. And we expect to be able to execute very effectively.

我們最近也獲得了 Otezla 的專利審批結果，這無疑有助於使其成為我們非常具有戰略意義的產品，對公司的發展至關重要。而且尺寸非常合適。我們已將原 Celgene 團隊完全整合到安進公司。目前，恩利（Enbrel）和奧特茲拉（Otezla）都在風濕病學和皮膚病學領域中推廣。我們看到銷量成長在第三季末期最為顯著，而且這種成長動能一直延續到第四季。顯然，我們在進行交易時並沒有預料到會發生疫情，但我們挺過來了。團隊保持專注，我們已為輕度至中度的發布做好了充分準備。我們預計美國食品藥物管理局（FDA）很快就會就此作出決定。我們擁有所需的資源。我們已經訓練了團隊。為了迎接審核的到來，我們已加大在皮膚科領域的投入。我們預計能夠非常有效地執行。

We also have very, very strong payer coverage here. And we think that the majority of these mild-to-moderate patients, and we're targeting a specific subset. We're targeting those patients that have larger body surface area or very difficult to treat areas with topicals. So that's about a 1.5 million patient population. So it's a large opportunity. 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.

我們這裡也有非常非常強大的支付方支援。我們認為這些患者大多為輕度至中度患者，而我們的目標是其中的特定群體。我們的目標是那些體表面積較大或局部用藥難以治療的患者。所以患者人數大約有150萬人。所以這是一個絕佳的機會。但我們認為，該產品的特性，以及該產品相對於生物製劑的價格定位，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. And I think that might bode well for future competition that's currently in the process, I guess, of being filed with the FDA.

我還要補充一點，我們預計在 PSA 領域比在銀屑病領域會受益更多，但坦白說，目前 JAK 的安全問題反而有助於 Otezla 的發展，並提升人們對我們安全性和有效性的整體認知。我認為這對目前正在向美國食品藥物管理局 (FDA) 提交申請的未來競爭來說可能是一個好兆頭。

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

你的下一個問題來自卡特·古爾德在巴克萊銀行的職位。

Maybe to change it up a little bit. 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. And I guess alongside that, when your partner disclosed the orphan drug designation, they talked about a planned Phase III. Should that be the expectation that you'll move straight into Phase III versus doing some Phase II work here?

或許可以稍微改一下。我想了解tezepelumab在EoE領域的產品線延伸策略，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。我猜與此同時，當你的伴侶透露孤兒藥資格時，他們也談到了計畫中的 III 期臨床試驗。是不是代表你會直接進入第三階段，而不是先完成一些第二階段的工作？

Yes. Thanks, Carter. Eosinophilic esophagitis or EOE, as it's called in the field, is an increasingly diagnosed condition. 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. This makes a lot of sense. 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. So I think it's the evidence package across the molecule here that supports that.

是的。謝謝你，卡特。嗜酸性食道炎（EOE）是一種診斷率不斷上升的疾病。在過去十年中，許多患有燒心症狀的患者通常會被診斷為反流，但現在，鑑於 tezepelumab 的作用機制，以及我們在氣喘的一些生物標誌物和組織獲取研究中觀察到的靶組織中嗜酸性粒細胞的減少，相當一部分患者現在被認為是嗜酸性粒細胞性食道炎。這很有道理。因此，我們正與合作夥伴一起，根據我們在第一階段獲得的數據，將這項研究推進到第三階段。所以我認為，從整個分子層次來看，所有證據都支持這個觀點。

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.

艾麗卡，眼看快到整點了，我們再回答一個問題吧，之後我會請鮑伯做一些總結性評論。

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

你的最後一個問題源自於麥可·施密特與古根漢的關係。

This is Kelsey on for Michael. Could you maybe just discuss kind of your latest thoughts around potential accelerated approval opportunity in the frontline setting for lung cancer? And maybe when you might expect to have kind of a clear path forward one way or the other from the FDA?

這裡是凱爾西替邁克爾報道。您能否談談您對肺癌一線治療中潛在的加速審批機會的最新想法？或許你什麼時候才能從FDA得到一個明確的前進方向？

Yes. Thanks for the question. The FDA has been generally clear that in the first-line setting, randomized data are required. 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. When we have those Phase II data available, of course, if we saw interesting data, we would have the appropriate discussions with regulators. But I think the general expectation is that barring significant results, one will expect randomized trials in frontline lung cancer.

是的。謝謝你的提問。FDA 已明確表示，在一線治療中，需要隨機對照試驗數據。正如我之前提到的，我們正在對 STK11 和/或 PD-L1 陰性或低表達腫瘤患者進行試驗，因為檢查點抑制劑對這些患者並不特別有效。當然，當我們獲得二期臨床試驗數據後，如果發現有趣的數據，我們會與監管機構進行適當的討論。但我認為，普遍的預期是，除非有重大成果，否則人們將會期待在肺癌一線治療領域進行隨機試驗。

Bob?

鮑伯？

Okay. 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. 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. So exciting time for us. Look forward to gathering with you in the new year. Again, thanks for your support.

好的。好的，讓我再次感謝各位參加我們的電話會議，我們期待在新的一年裡有機會與各位見面，屆時我們將報告第四季度的情況。顯然，從現在到那時，我們將有很多令人興奮的事情發生，首先，我們預計 Otezla 的擴大適應症將隨後推出 tezepelumab 的上市適應症，並啟動一些新的 III 期試驗項目，正如我們在電話會議上指出的那樣。對我們來說，這是個令人興奮的時刻。期待在新的一年與您相聚。再次感謝您的支持。

Great. Thanks, everybody.

偉大的。謝謝大家。

This concludes Amgen's Third Quarter 2021 Financial Results Conference Call. You may now disconnect.

安進公司2021年第三季財務業績電話會議到此結束。您現在可以斷開連線了。