美國安進 (AMGN) 2020 Q3 法說會逐字稿

My name is April, and I will be your conference facilitator today for Amgen's Third Quarter 2020 Financial Results Conference Call. (Operator Instructions)

我是April，今天將擔任安進公司2020年第三季財務業績電話會議的主持人。 （操作說明）

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

現在我謹介紹投資人關係副總裁阿文德‧蘇德先生。蘇德先生，您可以開始了。

Okay. Thank you, April. Good afternoon, everybody. I, together with several members of our leadership team that you will hear from today, would like to welcome you to our Q3 call. The format of our Q2 call was very well received. So we'll stick to keeping our prepared comments to a minimum and limit the overall duration of the call to 1 hour. The slides have been posted.

好的。謝謝你，April。大家下午好。我和今天將要發言的幾位領導團隊成員一起，歡迎大家參加我們的第三季電話會議。第二季電話會議的形式反應很好。因此，我們將盡量減少事先準備好的發言，並將會議總時長控制在1小時以內。幻燈片已經上傳。

Just a quick reminder that we use non-GAAP financial measures in our presentation, and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

特此提醒，我們在簡報中使用了非GAAP財務指標，且部分陳述屬於前瞻性陳述。我們的10-K表格及後續文件中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. Thank you for joining today's call. I'll take a few moments to discuss our performance in the third quarter and then share some thoughts on the overall operating environment in a COVID context.

好的。感謝各位參加今天的電話會議。我將花幾分鐘時間討論我們第三季的業績，然後分享一些關於新冠疫​​情背景下整體營運環境的看法。

We delivered another strong quarter. And you can see that in our revenue growth of 12%. And in addition, once again, this quarter, our revenue growth exceeded expense growth, enabling us to report earnings per share growth well ahead of revenues.

我們又迎來了一個強勁的季度。這一點從我們12%的營收成長中可見一斑。此外，本季我們的營收成長再次超過了支出成長，因此我們能夠實現每股收益遠超過營收成長的目標。

Putting the results in a broader context, our double-digit increase in revenues was driven by the continued volume-driven growth of many of our innovative products, the strong uptake of our high-quality biosimilars and the relative stability of our base business, which is proving resilient in the face of increased competition. We expect these 3 factors to be key for our long-term success.

從更廣闊的視角來看，我們兩位數的營收成長主要得益於眾多創新產品銷售持續成長、高品質生物相似藥的強勁市場需求以及基礎業務的相對穩定——在日益激烈的競爭中，基礎業務展現出了強大的韌性。我們預期這三大因素將是我們長期成功的關鍵。

Turning to COVID-19. Clearly, the pandemic remains an important factor affecting performance for Amgen and for our industry. You'll recall that Amgen grew revenues by 11% in the first quarter of the year, with the first 10 weeks of performance largely unaffected by the pandemic. In the second quarter, when conditions were at their worst, revenues grew by 6%.

談到新冠疫情。顯然，疫情仍是影響安進公司及整個產業績效的重要因素。您可能還記得，安進公司今年第一季營收成長了11%，其中前10週的業績基本上未受疫情影響。第二季度，疫情情勢最為嚴峻，營收也僅成長了6%。

Our performance in the third quarter reflects an encouraging recovery from the depths of the pandemic and was largely consistent with what we anticipated for you in our remarks at the time of our second quarter call. As regards to the fourth quarter, we see the current resurgence in cases as a potential headwind for our business. We are closely monitoring this to see what the impact may be for the rest of the year and if there might be any spillover into 2021.

第三季業績反映出我們從疫情低谷中令人鼓舞的復甦，基本上符合我們在第二季財報電話會議的預期。至於第四季度，我們認為目前病例的再次激增可能會對我們的業務構成潛在不利因素。我們正在密切關注疫情發展，以評估其對今年剩餘時間的影響，以及是否會對2021年產生任何影響。

We don't expect anything like what we saw earlier in the year as global health care systems know much more about how to treat COVID-19 and are better prepared to do so than they were earlier in the year. However, on the margin, we're not ruling out that there will be some impact, and we've tried to incorporate this into our planning assumptions for the fourth quarter and into the beginning of next year.

我們預計不會出現類似年初的情況，因為全球醫療衛生系統對新冠肺炎的治療方法有了更深入的了解，也比年初時準備得更充分。然而，我們並不排除疫情會造成一定影響，並已將此因素納入第四季和明年年初的規劃假設中。

Overall, I remain optimistic that innovation from the biopharma industry will break the back of this pandemic, vaccines, antibodies and other therapeutics that are being developed with unprecedented speed and collaboration. One thing this pandemic has exposed is the importance of innovation. And that, of course, is at the core of our strategy, and it's reflected in the first-in-class molecules that are advancing rapidly in our pipeline.

總的來說，我對生物製藥產業的創新最終戰勝這場疫情仍然保持樂觀，疫苗、抗體和其他療法的研發正以前所未有的速度和協作力度進行。這場疫情凸顯了創新的重要性。當然，創新是我們策略的核心，也體現在我們研發管線中那些快速推進的首創分子。

We are pleased, of course, with the Phase II results of our first-in-class molecule sotorasib, and we expect to see top line Phase III data for tezepelumab, our potential first-in-class treatment for severe asthma by year-end.

當然，我們對首創分子 sotorasib 的 II 期試驗結果感到滿意，並期待在年底前看到我們潛在的首創重度氣喘治療藥物 tezepelumab 的 III 期試驗主要數據。

We're also making good progress with several of our half-life extended BiTE molecules, particularly in solid tumors, like prostate and small cell lung cancer.

我們在幾種延長半衰期的 BiTE 分子方面也取得了良好的進展，尤其是在實體腫瘤方面，如前列腺癌和小細胞肺癌。

All the work that we do is taking place at a time when more is expected of companies than ever before. We understand these expectations and are committed to good corporate citizenship and sustainable operations.

我們所做的一切都發生在企業面臨前所未有的更高期望的時代。我們理解這些期望，並致力於履行良好的企業公民責任和實現永續營運。

Before I turn things over to the rest of the team, let me thank our staff members around the world for their unwavering commitment to serving patients during this challenging time. Their resilience, creativity and ability to execute give me great confidence in our long-term future. Dave?

在將工作交給團隊其他成員之前，請允許我感謝全球各地的員工，感謝他們在這段充滿挑戰的時期始終如一地為患者服務。他們的韌性、創造力和執行力讓我對我們的長期未來充滿信心。戴夫？

Thanks, Bob. I'll begin with sotorasib, our first-in-class KRAS G12C inhibitor. Based on the data we have accumulated and the evolution of the field, we are extremely optimistic about the potential of sotorasib, and we'll continue to aggressively advance the development program. Earlier this month, we reported positive top line results from our Phase II monotherapy study in advanced non-small cell lung cancer, demonstrating an objective response rate consistent with our Phase I data at 960 milligrams and promising results on other measures of efficacy, including duration of response, with more than half of the responders still on treatment at the data cutoff.

謝謝，鮑伯。我先來說說索托拉西布，這是我們首創的KRAS G12C抑制劑。基於我們累積的數據和該領域的進展，我們對索托拉西布的潛力非常樂觀，並將繼續積極推進其研發項目。本月初，我們公佈了針對晚期非小細胞肺癌的II期單藥治療研究的積極頂線結果，960毫克劑量組的客觀緩解率與I期數據一致，其他療效指標（包括緩解持續時間）也顯示出令人鼓舞的結果，截至數據截止日期，超過一半的緩解患者仍在接受治療。

Safety and tolerability were similar to previously reported data for this population and have been remarkably consistent across the 160 patients treated with our Phase II dose. Our Phase I and Phase II data are based on protocol specified intent-to-treat criteria, as is our practice, and the scans to assess efficacy parameters in Phase II have been evaluated by independent central review. We look forward to presenting the Phase II results at the World Congress on Lung Cancer taking place in January.

安全性和耐受性與先前報告的該族群數據相似，並且在接受我們二期劑量治療的160例患者中表現出顯著的一致性。我們的一期和二期資料均基於方案規定的意向性治療標準，這符合我們的慣例。二期療效評估的掃描結果已由獨立的中心審查機構進行評估。我們期待在1月舉行的世界肺癌大會上公佈二期研究結果。

We also reviewed with interest of data presentation made a few days ago. Based on our assessment of available efficacy and safety data, including durability measures, we remain extremely confident in our molecule. To date, we have treated over 550 patients with sotorasib, and we are looking forward to discussions with the FDA and other regulatory agencies to determine the best path forward as monotherapy in patients with advanced lung cancer. We couldn't be more enthusiastic about our position as we move towards establishing sotorasib as a KRAS G12C foundational therapy.

我們也饒有興趣地審閱了幾天前的資料展示。基於我們對現有療效和安全性數據（包括持久性指標）的評估，我們對我們的分子仍然充滿信心。迄今為止，我們已使用 sotorasib 治療了超過 550 名患者，並期待與 FDA 和其他監管機構進行討論，以確定其作為晚期肺癌單藥療法的最佳發展路徑。我們正朝著將 sotorasib 確立為 KRAS G12C 基礎療法的目標邁進，對此我們感到無比振奮。

We also remain optimistic about our BiTE platform. We now have evidence of clinical activity in solid tumors, including recently presented prostate cancer data from AMG 160, which targets prostate-specific membrane antigen. The benefit risk profile of AMG 160 has continued to improve with additional dose optimization.

我們對BiTE平台仍保持樂觀。目前我們已獲得其在實體瘤中展現臨床活性的證據，包括近期發表的AMG 160在前列腺癌中的數據，該藥物靶向前列腺特異性膜抗原。隨著劑量優化，AMG 160的獲益風險比持續改善。

AMG 757 is our half-life extended BiTE targeting DLL3, which is a very attractive target due to its differential expression in small cell lung cancers, and we look forward to presenting initial data at the Society for Immunotherapy of Cancer Annual Meeting next month. Small cell lung cancer is a large unmet medical need globally, and yet treatment options have not advanced significantly in decades. We will also investigate AMG 757 for the treatment of neuroendocrine tumors.

AMG 757 是我們研發的一種半衰期延長的雙特異性抗體（BiTE），可針對 DLL3。 DLL3 在小細胞肺癌中差異表達，因此是一個極具吸引力的標靶。我們期待下個月在癌症免疫治療學會年會上公佈初步數據。小細胞肺癌是全球亟待解決的重大醫療難題，然而數十年來，其治療方案並未取得顯著進展。我們也將研究 AMG 757 在神經內分泌腫瘤治療的應用。

We expect to present data from AMG 701 targeting BCMA for multiple myeloma later in the year as well. And before leaving the BiTE platform, I wanted to mention the Phase II publication in the New England Journal of Medicine that reported deep responses and a tolerable safety profile for dasatinib induction followed by BLINCYTO consolidation in adults with Philadelphia chromosome positive ALL. 60% of patients achieved a molecular response, and disease-free survival was 88% at 18 months, highlighting the potential of a chemotherapy-free regimen. If these results are confirmed in larger trials, this could lead to a potential paradigm shift in the treatment of this disease.

我們預計今年稍後也將公佈BCMA標靶治療多發性骨髓瘤的AMG 701的數據。在離開BiTE平台之前，我想提及發表在《新英格蘭醫學雜誌》上的II期臨床試驗結果，該試驗報告了達沙替尼誘導治療後序貫BLINCYTO鞏固治療在費城染色體陽性急性淋巴細胞白血病（ALL）成人患者中取得的深度緩解和良好的安全性。 60%的患者達到分子學緩解，18個月無疾病存活率為88%，凸顯了無化療方案的潛力。如果這些結果在更大規模的試驗中得到證實，則可能徹底改變疾病的治療模式。

In cardiovascular disease, we recently released the top line results from our omecamtiv mecarbil Phase III outcome study, and the results will be presented at the American Heart Association Scientific Sessions in November.

在心血管疾病領域，我們最近發布了 omecamtiv mecarbil III 期結果研究的主要結果，這些結果將於 11 月在美國心臟協會科學會議上發表。

In inflammation, along with AstraZeneca, we look forward to the top line results of the pivotal tezepelumab Phase III study, NAVIGATOR, in patients with severe uncontrolled asthma, which remains on track. We also expect the results from the oral corticosteroid-sparing Phase III study, SOURCE, by the end of the year, which should complement the pivotal data.

在發炎治療領域，我們與阿斯特捷利康共同期待關鍵性 tezepelumab III 期研究 NAVIGATOR 的主要結果，該研究針對的是重度未控制氣喘患者，目前進展順利。我們也預計，口服糖皮質激素替代療法 III 期研究 SOURCE 的結果將於年底公佈，這將對關鍵性數據起到補充作用。

I'm happy to announce that we will be advancing our third inflammation program into Phase II development next year with AMG 592, now named efavaleukin alfa, our IL-2 mutein for systemic lupus erythematosus. The trial was selected for inclusion in the FDA's complex innovative trial designs pilot program, which supports the development and regulatory review of novel clinical trial designs for new therapies.

我很高興地宣布，明年我們將把第三個發炎治療計畫推進到 II 期臨床試驗階段，該計畫使用 AMG 592（現更名為依伐白介素α），一種用於治療系統性紅斑狼瘡的 IL-2 突變體。該試驗已入選 FDA 的複雜創新試驗設計試點項目，該項目旨在支持新療法的新型臨床試驗設計的開發和監管審查。

In closing, I would like to thank all of the Amgen teams for executing at such a high level during the ongoing pandemic. Murdo?

最後，我要感謝安進所有團隊在疫情期間保持如此高水準的執行力。 Murdo？

Thanks, Dave. We've seen volumes continue to improve from the initial stages of the pandemic with Q3 global revenues growing 12% year-over-year, driven by 18% volume growth.

謝謝戴夫。我們看到銷售量從疫情初期開始持續改善，第三季全球營收年增12%，主要得益於銷售量成長18%。

During Q3, physician-patient interactions increased to near pre-COVID levels. Across the industry, in the U.S., total prescriptions are still down approximately 2% and physician visits, either in person or remote, are down approximately 10% versus the pre-COVID baseline. While trends improved during the quarter, we are seeing infection rates rise in many parts of the world, which may bring additional quarter-to-quarter variability.

第三季度，醫病互動已恢復至接近新冠疫情前的水準。但就整個產業而言，在美國，處方總量仍比疫情前下降約2%，而醫師就診量（包括線上和線下就診）則下降約10%。儘管本季情況有所改善，但我們看到世界許多地區的感染率仍在上升，這可能會導致季度間的波動。

Let me spend a few minutes to discuss our Q3 performance and outline our expectations for the remainder of 2020. In bone health, our efforts are focused on ensuring patient continuity. We grew Prolia volume by 10% year-over-year, even though osteoporosis diagnosis rates have returned to just 70% of pre-COVID levels in the U.S. COVID has also resulted in a change in historical quarterly trends for Prolia.

請容許我花幾分鐘時間談談我們第三季的業績，並概述我們對2020年剩餘時間的預期。在骨骼健康方面，我們致力於確保患者治療的連續性。儘管美國骨質疏鬆症的診斷率僅恢復到新冠疫情前水準的70%，但我們的Prolia銷量仍較去年同期成長了10%。新冠疫情也改變了Prolia以往的季度銷售趨勢。

Prior to the pandemic, the first and third quarters each year had lower sales than the second and fourth quarters. However, given the impact of the pandemic in the second quarter and the 6-month dosing regimen of Prolia, we would expect year-over-year growth rates in the fourth quarter to be lower than pre-COVID growth trends.

疫情爆發前，每年第一季和第三季的銷售額均低於第二季和第四季。然而，考慮到疫情對第二季的影響以及Prolia的6個月給藥方案，我們預期第四季的年增速將低於疫情前的成長趨勢。

With the current rise in COVID infection rates in the U.S. and Europe, there could be additional delays in patients receiving their Prolia treatment in Q4.

鑑於目前美國和歐洲 COVID 感染率的上升，第四季度接受 Prolia 治療的患者可能會進一步延遲。

EVENITY sales in the U.S. grew quarter-over-quarter, driven by 30% volume growth. This growth was offset by lower sales in Japan, which were partially related to timing of purchases by our partner, Astellas. We believe EVENITY's unique bone-building abilities will continue to drive growth in our business as physicians appreciate its benefit risk profile in treating their post fracture patients.

EVENITY在美國的銷售額環比成長，主要得益於30%的銷售成長。但日本市場的銷售額有所下降，部分原因是由於我們的合作夥伴安斯泰來(Astellas)的採購時間表所致，從而抵消了美國市場的這一增長。我們相信，隨著醫生們逐漸認可EVENITY在治療骨折後患者方面的獲益風險比，其獨特的骨骼重建能力將繼續推動我們業務的成長。

Repatha sales increased 22% year-over-year, driven by 60% volume growth. And as the segment leader globally (inaudible) us. We remain confident in our ability to grow Repatha given the significant unmet medical need in treating high-risk cardiovascular patients, our comprehensive payer coverage, the convenient self-administration and established outcomes data in the label.

瑞百安（Repatha）銷售額較去年同期成長22%，主要得益於銷量成長60%。身為全球此細分市場的領導者，我們對瑞百安的成長能力充滿信心，因為在治療高風險心血管疾病患者方面存在巨大的未滿足醫療需求，我們擁有全面的醫保覆蓋範圍，方便患者自行給藥，且藥品說明書中已證實了其療效。

Moving on to Parsabiv, which is an attractive treatment for secondary HPT, supported by the convenience of its IV administration. In January 2021, reimbursement for Parsabiv will move into the dialysis bundle payment system. We've already begun to see some negative impact on Parsabiv utilization in the U.S., and we would expect this impact to continue in Q4.

接下來談談帕薩比夫（Parsabiv），它是一種治療繼發性副甲狀腺功能亢進（HPT）的有效藥物，靜脈注射給藥非常方便。 2021年1月，帕薩比夫的健保報銷將納入透析捆綁支付系統。我們已經開始看到帕薩比夫在美國的使用率受到一些負面影響，預計這種影響將在第四季持續。

Transitioning to our inflammation portfolio, total prescriptions for Otezla in the U.S. grew 11% year-over-year. Underlying volume trends remain strong. Sales were negatively impacted by lower inventory levels versus last year. We're confident that Otezla will continue its double-digit year-over-year volume growth based on its well-established safety and efficacy profile, convenient oral dosage, broad payer coverage and the lack of lab monitoring requirements.

在我們的發炎治療產品組合中，Otezla 在美國的總處方量年增 11%。潛在的銷售成長趨勢依然強勁。與去年相比，庫存水準下降對銷售額造成了一定影響。我們相信，憑藉 Otezla 已確立的安全性和有效性、便捷的口服給藥方式、廣泛的醫保覆蓋範圍以及無需實驗室監測等優勢，其銷量將繼續保持兩位數的同比增長。

Enbrel remains the cornerstone of our inflammation franchise, and we continue to invest in Enbrel, along with our broader inflammation portfolio, including Otezla, AMGEVITA and recently launched AVSOLA. Enbrel was impacted by slowing growth in rheumatology prescribing in Q3 related to COVID and experienced some share loss in the quarter, while maintaining price stability year-on-year. Continued softness in rheumatology prescribing related to rising COVID infections could further impact Enbrel in the fourth quarter.

恩利仍然是我們發炎產品線的基石，我們將繼續投資恩利以及我們更廣泛的發炎產品組合，包括奧特茲拉、AMGEVITA 和最近上市的 AVSOLA。受新冠疫情影響，第三季風濕病處方成長放緩，恩利的市佔率下降，但價格較去年同期保持穩定。如果新冠感染病例持續增加，風濕病處方持續疲軟，可能在第四季進一步影響恩利的表現。

Our Q3 biosimilar revenues were $480 million, supported by share growth by MVASI and KANJINTI. We've achieved leading biosimilar shares for AMGEVITA in Europe and for MVASI and KANJINTI in the U.S. Our highly efficient operating model and full complement of patient services provide an important advantage as we face additional biosimilar competitors heading into 2021.

第三季生物相似藥收入為 4.8 億美元，主要得益於 MVASI 和 KANJINTI 的市佔率成長。我們在歐洲的 AMGEVITA 以及在美國的 MVASI 和 KANJINTI 均取得了領先的生物相似藥市場份額。我們高效率的營運模式和完善的病患服務體系為我們應對 2021 年即將到來的更多生物相似藥競爭對手提供了重要的優勢。

In oncology, Neulasta Onpro remains the preferred long-acting G-CSF with 55% share of volume in the quarter. Neulasta sales decreased 22% year-over-year, driven by declines in volume and net selling price. Competitive activity and long-acting [filgrastim] is impacting average selling price. The most recent published average selling price for Neulasta in the U.S. declined 19% year-over-year and 6% quarter-over-quarter.

在腫瘤治療領域，Neulasta Onpro 仍然是首選的長效粒細胞集落刺激因子 (G-CSF)，本季市佔率為 55%。受銷量和淨售價下降的影響，Neulasta 的銷售額年減 22%。競爭對手的活動以及長效藥物非格司亭 (filgrastim) 的出現正在影響其平均售價。 Neulasta 在美國最新公佈的平均售價年減 19%，季減 6%。

Overall, I'm very pleased with our Q3 performance. We remain vigilant as the pandemic continues to create uncertainty and potential disruptions in the health care marketplace. Amgen employees around the world are focused on ensuring continuity of care for our patients, and we'll continue investing to drive growth of our innovative products, advance our geographic expansion and prepare for potential new product launches.

整體而言，我對我們第三季的業績非常滿意。鑑於疫情持續為醫療保健市場帶來不確定性和潛在衝擊，我們仍保持高度警覺。安進全球員工致力於確保患者獲得持續的醫療服務，我們將持續加大投入，推動創新產品的成長，推動地域擴張，並為潛在的新產品上市做好準備。

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

接下來，我將把麥克風交給彼得。

Thank you, Murdo. Consistent with the first half of the year, we executed effectively during the third quarter, delivering 12% revenue and 19% non-GAAP EPS year-over-year growth.

謝謝你，默多。與上半年一樣，我們在第三季也高效執行，實現了營收年增12%，非GAAP每股收益較去年同期成長19%。

As you heard Murdo say, revenue growth was driven by volume increases of 18%, consistent with our focus on volume driven growth. Third quarter non-GAAP operating expenses increased 10% year-over-year and 9% quarter-over-quarter as we accelerated our investments to drive growth and advance the pipeline.

正如您聽到的默多所說，營收成長主要得益於銷量成長18%，這與我們以銷量驅動成長的策略重點相符。第三季非GAAP營運費用年增10%，季增9%，原因是我們加快了投資步伐，以推動成長並推進產品線。

Although activity levels during Q3 were still partially impacted by COVID-19, most trials continue to enroll patients. Customer-facing commercial activity levels increased and launch preparations were in process. We see activity levels increasing in the fourth quarter of the year, resulting in increased investments.

儘管第三季的業務活動仍受到新冠疫情的部分影響，但大多數臨床試驗仍在繼續招募患者。面向客戶的商業活動增加，產品上市準備工作也正在進行中。我們預計第四季度業務活動將持續成長，從而帶動投資增加。

We have financial flexibility with $12.4 billion in cash and investments on our balance sheet and continue to generate stable free cash flow with $3.2 billion in the quarter. Additionally, our third quarter dividend was $1.60 per share, an increase of 10% over last year. Our capital allocation principles and plans remain unchanged and uninterrupted.

我們擁有124億美元的現金和投資，財務狀況靈活，本季自由現金流達32億美元，持續穩定。此外，第三季每股派息1.60美元，較去年同期成長10%。我們的資本配置原則和計劃保持不變，未受影響。

Let me now share some thoughts on our 2020 outlook going forward. We are narrowing our revenue guidance to $25.1 billion to $25.5 billion from $25.0 billion to $25.6 billion. The range reflects the uncertainty created by the recent resurgence of COVID-19 infections globally, which Bob discussed in his remarks. And as you just heard Murdo say, our products, including Prolia, for the most at-risk COVID patients are most susceptible to the accelerated rate of infections.

現在我想和大家分享我們對2020年前景的一些看法。我們將營收預期從250億美元至256億美元下調至251億美元至255億美元。這個範圍反映了近期全球新冠肺炎疫情反彈帶來的不確定性，鮑伯在演講中也提到了這一點。正如你們剛才聽到的默多所說，我們的產品，包括Prolia，是專門針對高危險群新冠肺炎患者設計的，因此最容易受到疫情加速蔓延的影響。

The lower end of our range takes into account a more accelerated impact from COVID globally. We are raising our non-GAAP earnings per share guidance to $15.80 per share to $16.15 per share versus our prior guidance of $15.10 per share to $15.75 per share. We continue to believe that we could experience fluctuations in our quarterly revenues and earnings over the duration of the pandemic.

我們預期範圍的下限反映了新冠疫情在全球加速蔓延的影響。我們將非GAAP每股盈餘預期上調至每股15.80美元至16.15美元，高於先前預期的每股15.10美元至15.75美元。我們仍然認為，在疫情期間，我們的季度營收和獲利可能會出現波動。

As we shared during our Q2 call, we expect full year total non-GAAP operating expenses to grow in the high single-digit percentage range year-over-year on an absolute basis. We expect fourth quarter non-GAAP operating expenses to grow at about 20% on a quarter-over-quarter basis.

正如我們在第二季財報電話會議上所述，我們預計全年非GAAP營運費用總額將年增，增幅接近兩位數百分比。我們預計第四季非GAAP營運費用將較上季成長約20%。

Now let me share a bit more detail on our non-GAAP expectations for the full year 2020. Cost of sales as a percent of product sales will be generally consistent with 2019. We plan to increase R&D investments in the fourth quarter of the year as clinical trial and laboratory activities continue to recover from COVID-related slowdowns.

現在讓我更詳細地介紹我們對2020年全年的非GAAP預期。銷售成本佔產品銷售額的百分比將與2019年基本持平。隨著臨床試驗和實驗室活動從新冠疫情相關的放緩中逐步恢復，我們計劃在今年第四季增加研發投入。

SG&A spend is projected to increase due to investments in Otezla and other growth brands, geographic expansion and launch preparations. We anticipate other income and expense to be a net expense of about $1.3 billion, which includes more than $130 million of benefit from mark-to-market gains on our equity investment portfolio in Q3.

由於對 Otezla 和其他成長型品牌的投資、地理擴張和新品上市準備工作，預計銷售、管理及行政費用將增加。我們預計其他收入和支出淨額約為 13 億美元，其中包括第三季股權投資組合按市值計價帶來的超過 1.3 億美元的收益。

We are updating non-GAAP tax rate guidance to 13% to 14% versus prior guidance of 13.5% to 14.5%. Our expectation for share repurchases are unchanged, at the lower end of our previously disclosed range of $3 billion to $5 billion.

我們將非GAAP稅率預期從先前的13.5%至14.5%調整為13%至14%。我們對股票回購的預期維持不變，仍為此前揭露的30億美元至50億美元區間的下限。

Finally, recall that Q4 of 2020 will be comparing against a partial quarter of Otezla sales and expenses in Q4 2019. So as we approach the end of 2020, we are pleased with our progress and execution this year, including the successful integration of Otezla, collaboration with BeiGene and transition from Astellas in Japan. As is customary, we will provide full 2021 guidance on our January call.

最後，請注意，2020 年第四季的數據將與 2019 年第四季部分數據（即 Otezla 的部分銷售額和支出）進行比較。因此，隨著 2020 年接近尾聲，我們對今年的進展和執行情況感到滿意，包括成功整合 Otezla、與百濟神州開展合作以及從日本安斯泰來公司完成業務過渡。按照慣例，我們將在 1 月的電話會議上提供完整的 2021 年業績指引。

This concludes the financial update. I'll turn it back to Bob to get going on Q&A.

財務更新到此結束。接下來交給鮑勃，請他開始問答環節。

Okay. April, why don't we open up the lines for questions. And perhaps you could start us by reminding our callers of the procedures for asking a question.

好的，艾普麗爾，我們不妨開通提問專線吧。或許你可以先提醒來電者提問的流程。

(Operator Instructions) And your first question comes from the line of Michael Yee from Jefferies.

（操作說明）你的第一個問題來自 Jefferies 的 Michael Yee。

I had a question on tezepelumab, of course, a really important readout coming soon, and it's an important drug. Just wanted to understand David's perspective on the importance of the low eosinophil group and in the context of the overall data and how important that is to hit there? And how that would change the overall profile and outlook for that drug?

我有一個關於tezepelumab的問題，當然，它即將公佈一項非常重要的研究結果，而且它也是一種非常重要的藥物。我只是想了解David對低嗜酸性粒細胞組重要性的看法，以及在整體數據背景下，達到該組目標有多重要？這將如何改變該藥物的整體特徵和前景？

Thanks, Mike. Yes. Of course, we're greatly looking forward to that readout as well. What I can say is that the trial is very well powered to look at. Outcomes on the primary endpoint here is annualized. Exacerbation rates, the standard endpoint for asthma studies across the different subgroups, including the low eosinophil population. So we feel very comfortable that this will be a definitive test of tezepelumab across the entire range of patients with severe asthma.

謝謝，麥克。是的。當然，我們也非常期待最終的結果。我可以肯定的是，這項試驗的樣本量非常充足。主要終點指標是年化結果，即氣喘急性發作率，這是氣喘研究中針對不同亞群（包括嗜酸性粒細胞減少族群）的標準終點。因此，我們非常有信心，這將是對所有重度氣喘患者使用tezepelumab的最終驗證。

We have the next question that comes from the line of Matthew Harrison from Morgan Stanley.

接下來的問題來自摩根士丹利的馬修·哈里森。

I guess, another question for Dave. Could you maybe just comment -- I know you commented on your opening remarks here on G12C. I guess the question here is, as we think about moving the response rate higher in terms of the combination studies that you have ongoing, what's your relative confidence around those studies either improving response rates or improving durability? And how do you think about your ability to progress them rapidly now that you have a good sense of the monotherapy activity of the compound?

我想再問Dave一個問題。您能否就您在G12C上的開場白發表一下看法？我知道您之前已經就此發表了評論。我想問的是，鑑於您正在進行的聯合用藥研究旨在提高緩解率，您對這些研究能否提高緩解率或延長療效持續時間有多大信心？既然您現在已經對該化合物的單藥治療活性有了較為清晰的了解，您認為您能否快速推進這些研究？

Yes. Thanks, Matt. That -- certainly, the combination studies are an important topic. They're moving forward quite briskly. We have, I think, 7 cohorts open now. 3 or 4 more are coming very soon. So we feel we are testing in a range of indications, the biologically plausible and clinically relevant combinations. We'll have data next year on a number of these. And to your point, the goal always in combination therapy beyond monotherapy is to enhance efficacy and potentially -- in terms of response rates, but also durability, if you are cutting off avenues of tumor resistance or escape. And that's certainly our goal. We're very much guided by the biology here. And as you look at those cohorts that are coming up, I think you'll see that that's the case.

是的，謝謝，馬特。當然，聯合用藥研究是一個重要的課題，而且進展非常迅速。目前我們已經啟動了7個佇列，還有3到4個佇列即將啟動。因此，我們認為我們正在針對一系列適應症進行測試，這些組合在生物學上合理​​且具有臨床意義。明年我們將獲得其中一些組合的數據。如您所說，聯合療法的目標始終是提高療效，並有可能提高緩解率，同時也能增強療效的持久性，從而阻斷腫瘤的抗藥性或逃脫途徑。這當然是我們的目標。我們非常注重生物學原理。當您查看即將啟動的隊列時，我想您會發現情況確實如此。

And next question comes from the line of Yaron Werber from Cowen.

下一個問題來自 Cowen 公司的 Yaron Werber。

David, I'm just going to maybe keep you on the spot on sotorasib. Some of the data or comments that we heard this week is that a computing product was well tolerated at the high dose with an EGFR inhibitor and pembro. If I remember correctly, at ESMO, I think your investigators said something along the lines, and correct me if I'm wrong, that it -- with your product with PD-1, there was tolerability that was -- it was addressed with dose reduction, something along those lines. I don't know if you don't mind, maybe exactly kind of correct what he said.

David，關於索托拉西布（sotorasib），我可能要問你一個問題。我們這週聽到的一些數據或評論說，一種計算產品在高劑量下與EGFR抑製劑和帕博利珠單抗（pembro）聯合使用時耐受性良好。如果我沒記錯的話，在ESMO大會上，你的研究人員好像說過類似的話（如果我記錯了請糾正我），就是說——你的產品與PD-1抑製劑聯合使用時，存在耐受性問題——可以通過降低劑量來解決，大概是這樣。我不知道你是否介意，能不能幫我準確地修正一下他說的內容。

And then secondly, on tezepelumab, our understanding is that the way the study is designed, it's actually incorporating the low eosinophil dose into one of the analysis in the primary endpoint, as a sub analysis. And so if you hit that, does that mean you get a broad label?

其次，關於tezepelumab，我們了解到，研究的設計實際上是將低嗜酸性粒細胞劑量納入主要終點分析的子分析中。那麼，如果達到該子分析結果，是否意味著可以獲得更廣泛的適應症？

Yes. Sure. So let me take those in order. In terms of the combinations, the one thing I would caution everyone is let's not overread anything into cohorts of 3 or 4 patients, whether that's our trials or anyone else's trials. We're moving forward. We've been -- what we have is a foundation of tolerability in monotherapy, which is the critical thing to build on in combinations. And I think this was put into some perspective by an editorial in the New England Journal of Medicine that accompanied the publication of our Phase I trial a few weeks ago, and I'd refer you to that. And certainly, it's very common in combination therapy development in oncology to look at all sorts of dosing and scheduling regimens, and we fully intend to do that. And our priority, we would intend on doing that.

是的，當然。那我按順序來說。關於合併用藥，我想提醒大家的是，不要過度解讀3到4名患者的隊列研究結果，無論是我們自己的試驗還是其他機構的試驗。我們正在穩步推進。我們已經—目前我們已經在單藥治療中建立了良好的耐受性基礎，這對於聯合用藥至關重要。幾週前，《新英格蘭醫學雜誌》發表了一篇社論，與我們I期臨床試驗的結果同時發布，我認為這篇社論對此有所闡述，我建議大家參考一下。當然，在腫瘤聯合療法研發過程中，研究各種給藥和給藥方案是非常常見的，我們也完全打算這麼做。而且，這將會是我們的首要任務。

And with regards to the analysis in tezepelumab. Yes, that's correct. I mean the analysis is powered and geared across the entire population, and with also a look at the low eosinophil population. So your suppositions there are correct.

關於tezepelumab的分析，是的，沒錯。我的意思是，這項分析是針對整個人群進行的，也關注了嗜酸性粒細胞減少的人群。所以你的假設是正確的。

And your next question comes from the line of Jay Olson from Oppenheimer.

你的下一個問題來自奧本海默公司的傑伊·奧爾森。

Congrats on the quarter. I just wanted to follow-up on the comments around KRAS G12C. The competing program that featured data over the weekend did report QT prolongation, including some cases of grade 3, 4. Is this a class effect? And have you seen any cases of QT prolongation with sotorasib? And how important is this cardiovascular safety finding and [disputation] (inaudible)?

恭喜本季取得佳績。我想就KRAS G12C相關的評論做個後續追蹤。週末公佈數據的競賽項目確實報告了QT間期延長，包括一些3級和4級病例。這是該類藥物的普遍效應嗎？您在使用索托拉西布（sotorasib）時是否觀察到過QT間期延長的病例？這項心血管安全性發現及其引發的爭議（聽不清楚）有多重要？

Yes. While I can't speak directly to other's data, of course, I'll allow them to do that. I will say that we've, as I mentioned, treated over 550 patients. There's no evidence whatsoever of a QT signal to date, and we remain quite pleased with the overall tolerability of sotorasib.

是的。雖然我不能直接評論其他人的數據，當然，我會讓他們自己去發布。我想說的是，正如我之前提到的，我們已經治療了超過550名患者。迄今為止，沒有任何證據表明存在QT間期延長訊號，我們對索托拉西布的整體耐受性仍然非常滿意。

Your next question comes from the line of Terence Flynn from Goldman Sachs.

你的下一個問題出自高盛的特倫斯·弗林之口。

Maybe I was just wondering if -- as you think about capital allocation, if the omecamtiv setback maybe changes anything on that front, particularly how you think about the cardiology opportunity for the company? And then a question for Peter. I was just wondering if you could give us a preliminary view of 2021 expenses just relative to this year. Just wondering if you're wrapping up a number of late-stage programs now. Why spend would grow next year?

我只是想問一下，在您考慮資本配置時，omecamtiv 的挫折是否會影響到這方面的決策，特別是您對公司在心臟病學領域發展機會的看法？另外，我想問 Peter 一個問題。您能否初步估算一下 2021 年的支出狀況，並比較一下與今年的支出。我想知道您是否正在完成一些後期專案？為什麼明年的支出會成長？

Okay. Terence, it's Bob. Why don't I take the first part of your question. The answer -- the short answer is no. The omecamtiv results don't change our thinking on capital allocation. We continue to look for business development opportunities and continue to look for internal programs in cardiovascular disease. As you know, we're moving rapidly with our Phase II program directed against Lp(a), so we're excited to have some advance studies going for that molecule. And we'll continue to look for ways to invest in that franchise.

好的，特倫斯，我是鮑伯。我先回答你問題的第一部分。答案——簡而言之，不會。 omecamtiv 的結果不會改變我們對資本配置的想法。我們會繼續尋找業務拓展機會，也會繼續尋找心血管疾病領域的內部專案。如你所知，我們正在快速推進針對 Lp(a) 的 II 期臨床試驗，因此我們很高興能夠進行一些針對該分子的早期研究。我們將繼續尋找投資該領域的方法。

Cardiovascular disease, as you know, a leading killer of people on the planet. We continue to think what we need in that field is more innovation, not less. So we'll continue looking for that.

如您所知，心血管疾病是全球主要的致死原因之一。我們始終認為，該領域需要的是更多創新，而不是更少。因此，我們將繼續尋求創新。

Terence, it's Peter. Thank you for your question. A good question. As you know, we'll guide on 2021 when we get to January. But I do want to just say, we always intend on continuing to be a top-performing biopharma firm looking at various financial metrics, always operating margin right there. So look, we're going to remain flexible and adaptable as attractive opportunities arise and with the underlying objective to grow our after-tax cash flow. So that's where we sit right now on expenses. We wanted to be clear on the fourth quarter and how that's going to sequence in, which is really on a normal historical basis, just at the upper end of it on an OpEx basis. So with that, I'll turn it over to the next question.

特倫斯，我是彼得。謝謝你的提問。問得好。如你所知，我們將在明年一月公佈2021年的業績指引。但我想強調的是，我們始終致力於成為一家業績領先的生物製藥公司，我們會關注各項財務指標，尤其是營運利潤率。所以，我們會保持靈活，抓住各種機遇，並以提升稅後現金流為根本目標。這就是我們目前的支出狀況。我們想明確一下第四季的支出安排，實際上，第四季的營運支出將與往年持平，只是略高於往年同期水準。那麼，接下來請你提問。

The next question is from the line of Evan Seigerman from Crédit Suisse.

下一個問題來自瑞士信貸的埃文·塞格曼。

Actually, one for Murdo, kind of on some of the dynamics in the biosimilar business. So you're talking about pricing headwinds as volumes increase. Are you seeing this more in the inflammation space? Or is this in oncology? And can you kind of provide some color as to how accounts generally, I guess, in the U.S. are using biosimilars? Is it more just totally for giving the brand and going all to the biosimilar? Or do you see some sort of a mix?

實際上，我想問默多一個問題，關於生物相似藥產業的一些動態。您提到隨著銷售成長，價格面臨阻力。您認為這種情況在發炎領域更常見嗎？還是在腫瘤領域比較常見？您能否簡單介紹一下美國客戶通常是如何使用生物相似藥的？他們是否完全放棄原廠藥而直接使用生物相似藥？還是兩者兼具？

Thanks, Evan. Yes, look, we're really pleased with what we've been able to do with our biosimilars business in the quarter. We were -- the team has done a really nice job this year despite COVID in establishing strong penetration into the U.S. oncology market with MVASI, our Avastin biosimilar; and KANJINTI, our Herceptin biosimilar.

謝謝，埃文。是的，你看，我們對本季生物相似藥業務的業績非常滿意。儘管受到新冠疫情的影響，但我們的團隊今年做得非常出色，憑藉我們的阿瓦斯汀生物類似藥MVASI和赫賽汀生物類似藥KANJINTI，成功打入了美國腫瘤市場。

I would say with respect to the dynamic in the market, a lot of people questioned whether or not we had an efficient functioning biosimilar market in the U.S. because I think they were over interpreting some of the early biosimilar launches. And I think what you can see now is that we have an efficient market that when there are -- when there's a clear value on the table, health care systems, providers and payers, are able to capitalize on it. And that's what's driving, of course, the uptake of our biosimilars.

就市場動態而言，許多人質疑美國生物相似藥市場是否有效率運轉，我認為他們過度解讀了早期一些生物相似藥的上市情況。而現在我們可以看到，我們擁有一個高效率的市場，當生物相似藥具有明顯的價值時，醫療系統、醫療服務提供者和支付者都能從中獲益。這當然也是推動生物相似藥普及的根本原因。

I also think that the experience we've had in defending against biosimilar erosion on products like Neulasta, has positioned us well to understand how accounts are looking to purchase biosimilars. So when we launched our own, we were able to take some advantage of that. And I would say that of the accounts that have opened up biosimilar usage, generally, initially, we thought they might be using biosimilars for new patients going forward, but we've actually seen them use our biosimilars, both for new patients and switching patients who are midcourse of treatment to biosimilars as well. So I'd say that the penetration at an account level has been deeper than we originally anticipated. And I think by now, there's fairly broad adoption in the U.S. at the 340B level, the non-340B level and, of course, within the clinics.

我認為，我們在應對Neulasta等產品生物相似藥的衝擊方面所累積的經驗，使我們能夠更好地了解客戶購買生物相似藥的方式。因此，當我們推出自己的產品時，我們能夠充分利用這些經驗。我想說的是，在那些已經開始使用生物相似藥的客戶中，我們最初認為他們可能會將生物相似藥用於未來的新患者，但實際上我們看到他們不僅將我們的生物類似藥用於新患者，還將正在接受治療的患者轉為使用生物相似藥。因此，我認為生物相似藥在客戶層面的滲透率比我們最初預期的要高。而我認為，目前在美國，無論是在340B計畫層面、非340B計畫層面，或是在臨床層面，生物相似藥的採用都相當廣泛。

Now that's oncology. It's a little different in inflammation. Depending on the biosimilar itself, whether it's an infused biosimilar or whether it's a self injected or self-administered biosimilar. And I think you need to watch that carefully because the 2 are not analogous. So I would treat each business segment as its own example and not draw comparisons from one to the other.

這是腫瘤學領域的情況。發炎領域的情況略有不同。這取決於生物相似藥本身，例如它是輸注型生物相似藥還是患者自行注射或給藥型生物相似藥。我認為需要仔細觀察這一點，因為兩者並不相同。所以我建議將每個業務領域視為獨立的例子，不要將它們之間進行比較。

All right. And your next question, sorry about that, is from the line of Chris Raymond from Piper Sandler.

好的。抱歉，你的下一個問題出自派珀桑德勒飾演的克里斯雷蒙德的台詞。

Yes, I was wondering if I could maybe ask on sotorasib again and take the conversation back there. So I heard, David, your commentary on hopes on the response rate in combo, but I think you guys are also working on a BID dose and if memory serves, I think we were -- maybe we were expecting to see something by year-end or at least in the coming months. So I wonder if you could sort of talk about your hopes with respect to that, potentially as a monotherapy BID? And then also on the same topic, can you just sort of confirm, does sotorasib have CNS activity? Can you give us any indication on that one?

是的，我想再問一下關於索托拉西布的問題，把話題轉回這個話題上來。大衛，我聽你談到了聯合治療方案中索托拉西布的療效預期，但我想你們也在研究每日兩次給藥方案，如果我沒記錯的話，我們之前預計——或許是年底前，或者至少在未來幾個月內——會有成果。所以我想請你談談你對每日兩次單藥治療的預期？另外，關於這個主題，你能否確認一下，索托拉西布是否有中樞神經活性？能否提供一些相關資訊？

Yes. Thanks, Chris. Both important questions. It's standard in any new molecule as part of the clinical pharmacology program to examine different schedules. So we continue to do that with twice daily dosing. But one thing I'd urge everyone to do is kind of go back to basic pharmacokinetics here as we think about this field and what are the reasons to go to split dosing.

是的，謝謝克里斯。這兩個問題都很重要。對於任何新分子而言，作為臨床藥理學計畫的一部分，研究不同的給藥方案都是標準流程。所以我們繼續研究每日兩次給藥方案。但我建議大家在思考這個領域以及採用分次給藥的原因時，回歸到基本的藥物動力學。

While there are really 2 reasons: one, if you need split dosing in order to achieve target coverage; or two, if you need to split the dose because of tolerability issues. And with sotorasib, we're very convinced that we are getting target coverage throughout the dosing interval with our once-daily dosing. And of course, we've got very nice tolerability at once-daily dosing. And so that's really -- this is, I think, basic pharmacology and pharmacokinetics and the science underlying that, that has driven our clinical choices.

實際上，分次給藥的原因主要有兩個：一是需要分次給藥才能達到標靶覆蓋率；二是需要分次給藥是因為耐受性問題。對於索托拉西布，我們非常確信，每日一次給藥即可在整個給藥間隔內達到標靶覆蓋率。當然，每日一次給藥的耐受性也非常好。因此，我認為，正是基礎藥理學、藥物動力學及其背後的科學原理，驅動了我們的臨床選擇。

In terms of CNS penetration, we did mention at ESMO, we have a couple of patients with -- 1 or 2 patients with CNS metastases who clearly had responses. So the question with small molecules or in CNS responses, in general, is always, is that due to true penetration or because there's typically a highly disrupted blood-brain barrier in that setting. You almost always get some exposure to drug.

關於中樞神經系統滲透性，我們在ESMO會議上提到過，我們有幾例——一兩例——中樞神經系統轉移患者，他們的治療反應非常明顯。所以，對於小分子藥物或中樞神經系統反應而言，通常需要思考的問題是：這種反應是因為藥物真正滲透，還是因為在這種情況下血腦障壁通常會高度受損？無論如何，幾乎總是能觀察到一些藥物暴露。

The third potential explanation, which we continue to explore is that it's a secondary immune activation that could potentially trigger activity in the central nervous system. We are exploring this question explicitly in a cohort that we're just opening for patients with brain metastases. And so I think in through next year, we'll have a good sense of potential activity in the central nervous system. Thank you.

第三種可能的解釋，也是我們正在繼續探索的，是它可能是一種繼發性免疫激活，進而觸發中樞神經系統的活動。我們正在一個新成立的腦轉移患者群中專門研究這個問題。因此，我認為到明年，我們將對中樞神經系統的潛在活動有更清晰的了解。謝謝。

And your next question comes from the line of Geoffrey Porges from SVB Leerink.

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

This is Andrew on for Geoff. So I have a question regarding tezepelumab's readouts. So if the study is successful, how might it be commercialized given the conflict that your partner has with (inaudible) for the same indication?

這裡是安德魯，替傑夫發言。我有一個關於tezepelumab研究結果的問題。如果這項研究成功，考慮到您的伴侶與（聽不清楚）就同一適應症存在利益衝突，它將如何商業化？

Yes. Thank you. I'll jump in on that one. We've obviously been very transparent with our partners on how we can commercialize tezepelumab. I have to say with the many years of experience that AstraZeneca has in this therapeutic area. We continue to believe they're an outstanding partner. We've worked through all the details of commercialization. AstraZeneca will indeed be putting up dedicated resources for the promotion of tezepelumab. So think about different sales reps literally in the market promoting the 2 different products.

是的，謝謝。我來補充一下。我們一直非常坦誠地與合作夥伴溝通，探討如何將tezepelumab商業化。阿斯特捷利康在該治療領域擁有多年經驗，我們始終認為他們是優秀的合作夥伴。我們已經敲定了商業化的所有細節。阿斯特捷利康確實會投入專門的資源來推廣tezepelumab。所以，您可以想像一下，屆時會有不同的銷售代表在市場上推廣這兩種不同的產品。

We will be handling many elements of the commercial process in the U.S. For example, we'll be lead on the market access, negotiations and relationships. While AstraZeneca will lead on consumer marketing and professional marketing. So I think we've really put the best of the best together here, and I continue to have a lot of confidence in the emphasis that our partner is placing on this really exciting molecule, both for the launch and also just strategic life cycle management ideas that they have as well.

我們將負責美國商業流程的諸多環節。例如，我們將主導市場准入、談判和客戶關係維護。而阿斯特捷利康將負責消費者行銷和專業行銷。所以我認為我們已經真正實現了強強聯合，我對合作夥伴對這款令人振奮的分子所給予的重視充滿信心，無論是在產品上市方面，還是在他們提出的戰略生命週期管理理念方面。

And your next question comes from the line of Ronny Gal from Bernstein.

你的下一個問題來自伯恩斯坦的 Ronny Gal 的一句台詞。

You've done really well with biosimilars, you're closing in on about $2 billion run rate from about $1 billion last year. I'm kind of wondering about the balance for next year, you're seeing significant competition coming in on both the Avastin and Herceptin biosimilars. You're launching to yourself and rituximab and infliximab, but the dynamic stem seem to be potentially tougher. If we're going to think about the next 12 months, should we -- can we expect the same kind of growth rate? Or is this asking for too much? And then separately, Murdo, I was wondering if you can comment on Repatha outlook? And how do you think about the competition with an RNA-based, physician office-based molecule?

你們在生物相似藥方面做得非常出色，年化銷售額從去年的約10億美元成長到接近20億美元。我有點擔心明年的市場平衡，因為你們在阿瓦斯汀和赫賽汀的生物相似藥領域都面臨著激烈的競爭。你們也推出了利妥昔單抗和英夫利西單抗，但這些動態變化的藥物似乎更具挑戰性。如果我們展望未來12個月，我們是否應該——或者說，我們能否期待同樣的成長速度？或者說，這樣的期望過高了？另外，默多，我想請您談談瑞百安的前景。您如何看待這種基於RNA、需要在醫生診間使用的藥物所帶來的競爭？

Okay. Thank you. Overall, I think the biosimilars business, as I said, has evolved really nicely, and we've penetrated quite well. If I look at the oncology products in the U.S. running at 44% share currently on our Avastin biosimilar, I do think as you see additional competitors come in, the average selling price will come down. So that's a reality that competition brings. And it's related to my comment earlier about this being an efficient marketplace.

好的，謝謝。總的來說，正如我之前所說，我認為生物相似藥業務發展得非常好，我們的市場滲透率也相當不錯。目前，我們的阿瓦斯汀生物相似藥在美國腫瘤產品市場佔有44%的份額。隨著更多競爭對手的加入，我認為平均售價會下降。這就是競爭帶來的必然結果。這也印證了我之前關於這是一個高效市場的觀點。

I do think there's an appreciation, though, for what we've done at Amgen, which is to have a very effective provider-focused, commercial presence, the same people that are talking to accounts about our innovative portfolio are talking to those same customers about our biosimilars. So all of our services that we normally have on an innovative product are available on biosimilars. And that includes patient services for things like reimbursement or copay assistance. And I think that differentiates us. So I would anticipate us being able to continue to capture good volume, albeit at some price erosion as we go into the new year. But as I said, we're at 44% share of the total bevacizumab market and slightly less than that of the trastuzumab market. So there's still a lot of headroom for growth.

不過，我認為大家對我們在安進所做的工作表示認可，那就是我們建立了高效的、以醫療服務提供者為中心的商業管道。負責向客戶介紹我們創新產品組合的人員，同時也負責向客戶介紹我們的生物相似藥。因此，我們通常在創新產品上提供的所有服務，在生物相似藥上也同樣適用。這包括為患者提供的服務，例如報銷或共付額援助。我認為這正是我們的優勢。所以我預計，儘管進入新的一年後價格可能會有所下降，但我們仍能繼續保持良好的銷售。正如我所說，我們目前佔據貝伐珠單抗市場44%的份額，略低於曲妥珠單抗市場。因此，我們仍有很大的成長空間。

And I think on the inflammation side, the dynamics are a little bit different depending on whether it's a product like our REMICADE biosimilar AVSOLA, or whether we're looking at a product like our Rituxan biosimilar. So I think we have to watch how we draw parallels on expectations.

我認為在發炎方面，不同產品的動態變化略有不同，例如我們的類克生物相似藥AVSOLA，和我們的利妥昔單抗生物相似藥。因此，我們需要注意如何對預期結果進行類比。

Overall, we made a big commitment to biosimilars. So we'll continue to advance new products through the clinic and into the market. And we compete effectively across Europe, and we're competing nicely so far in the U.S.

總的來說，我們對生物相似藥投入巨大。因此，我們將繼續推動新產品的臨床試驗和市場推廣。我們在歐洲的競爭非常有效，目前在美國的競爭也相當不錯。

Just transitioning to Repatha. Look, we've done, I think, an excellent job of converting to an affordable price of Repatha. We've got about 80% access coverage across Medicaid and commercial. And we're seeing really nice volume growth with 60% in the quarter. And I think we're also seeing some nice evolution outside of the U.S. where Repatha continues to gain share.

我們正在過渡到瑞百安（Repatha）。我認為，我們在將瑞百安的價格控制在合理範圍內方面做得非常出色。我們在醫療補助計劃（Medicaid）和商業保險中的覆蓋率達到了約 80%。而且，我們的銷量成長非常可觀，本季成長了 60%。我認為，在美國以外的市場，瑞百安的市場份額也持續成長，發展勢頭良好。

The product really with Repatha, we are scratching the surface of those that need this. There's a lot of high-risk coronary event patients who require more aggressive lipid-lowering therapy. And in light of COVID, I actually think that Repatha is a unique solution. It's a self-administered product with excellent coverage, a well-demonstrated efficacy and safety profile, and we have event reduction data in the label.

瑞百安（Repatha）這款產品，實際上我們只觸及了真正需要它的人群的冰山一角。有很多高危險群冠心病患者需要更積極的降脂治療。鑑於新冠疫情的影響，我認為瑞百安確實是一種獨特的解決方案。它是一種患者可自行給藥的產品，覆蓋範圍廣，療效和安全性均已得到充分證實，而且說明書中還有降低事件發生率的數據。

So I think compared to a product that might require patients to travel to a physician office for administration in light of COVID, that's going to be a tougher task for another product to come in. So I feel good about where we are, and I feel good about our growth prospects going forward.

所以我覺得，相較於那些可能需要病患在新冠疫情期間前往醫生診所進行用藥的產品，其他產品想要進入這個市場將會面臨更大的挑戰。因此，我對我們目前的狀況感到滿意，也對我們未來的發展前景充滿信心。

And your next question comes from the line of Colin Bristow from UBS.

你的下一個問題來自瑞銀集團的柯林布里斯托。

So another one on sotorasib. I'm just curious, like you have more data on this asset now. What's your current thinking around the potential to advance this to early or, I guess, first-line therapy in light of the strong data we've seen from IO agents in the G12C patients?

所以，關於索托拉西布（sotorasib）還有另一個問題。我很好奇，既然你們現在掌握了更多關於這種藥物的數據，鑑於我們在G12C患者中從免疫腫瘤藥物（IO）中看到的強有力數據，你們目前如何看待將其推進到早期治療，或者我猜想，一線治療的潛力？

Yes. Thanks, Colin. Great question. And of course, as is typical in oncology development programs, you start in later lines of therapy where patients don't have much in the way of treatment options, but certainly moving into earlier lines of therapy will be part of the development program as we move forward.

是的，謝謝科林。問得好。當然，正如腫瘤藥物研發計畫的慣例，我們會從治療選擇有限的後期療法入手，但隨著計畫的推進，進軍早期療法領域也必將成為研發計畫的一部分。

I'd also point out that an important part of the program in later lines is the head-to-head Phase III trial against docetaxel chemotherapy. That is very important outside of the U.S., in some jurisdictions for regulatory approval, but also in many jurisdictions for reimbursement. And so I wouldn't also overlook the potential of that. This is a global development program, and that's another important piece. Thank you.

我還想指出，該計畫後期研發的一個重要組成部分是與多西他賽化療藥物進行頭對頭III期臨床試驗。這在美國以外的地區非常重要，在某些地區，它關係到監管部門的批准，在許多地區，它關係到醫療保險報銷。因此，我也不認為應該忽略這項試驗的潛力。這是一個全球性的研發項目，也是其另一個重要組成部分。謝謝。

And your next question comes from the line of Mohit Bansal from Citibank.

你的下一個問題來自花旗銀行的莫希特·班薩爾。

Great. Maybe one question on tezepelumab in asthma. So as the data are coming up, how important do you think is to show the benefit in low eos patients? In case if it doesn't work, do you think your partner may not be interested in commercializing this product, given that they already have a product for high eos patients, and they may have 2 competing products in that area?

好的。關於tezepelumab在氣喘治療的應用，我還有一個問題。隨著相關數據的陸續公佈，您認為證明該藥物對低嗜酸性粒細胞（eos）患者有益有多重要？如果該藥物無效，考慮到您的合作夥伴已經擁有針對高嗜酸性粒細胞（eos）患者的產品，並且可能在該領域存在兩種競爭產品，您認為他們是否會對該產品的商業化不感興趣？

Yes. Well, let me start, and then I'll hand things off to Murdo. As we discussed, the primary endpoint is powered across the entire population and also the analysis plan allows a look in the low eosinophil group. In our Phase II data, which is currently our best predictor, we showed relatively comparable efficacy regardless of eosinophil status, and it certainly would be our hope that we're able to replicate that in Phase III.

是的。那麼，我先開始，然後把麥克風交給默多。正如我們之前討論的，主要終點是針對所有受試者進行的，而且分析方案也允許我們專注於低嗜酸性粒細胞組。在我們目前最好的預測指標－II期數據中，無論嗜酸性粒細胞狀態如何，我們都顯示出相對相似的療效，我們當然希望能在III期臨床試驗中重現這一結果。

In terms of commercialization, let me ask Murdo to weigh in.

關於商業化方面，我想請默多表達意見。

Yes. As I mentioned before, there's a strategic commitment here from our partners to teze. They've been very supportive, constructive and helpful as we work through the development plan. And now we look beyond that to commercialization and potential life cycle management ideas. And I think that there's a strong press from AstraZeneca to continue to really think about all of the patients that we can benefit with development of teze. I would just say that there's a large market opportunity here in severe asthma. Having alternative mechanisms in the market is a good thing. And I think that there's plenty of room for us to launch effectively there. And I'm pretty sure that's how our partners at AstraZeneca see it.

是的。正如我之前提到的，我們的合作夥伴對teze有著策略性的承諾。在製定開發計劃的過程中，他們給予了我們極大的支持、建設性的幫助和指導。現在，我們著眼於商業化和潛在的生命週期管理方案。我認為，阿斯特捷利康方面也強烈要求我們繼續認真思考teze的研發能惠及哪些病患。我想說的是，重度氣喘市場蘊藏著巨大的機會。市面上擁有替代療法是件好事。我認為我們完全有能力在這個領域有效地推出產品。而且我確信，我們的合作夥伴阿斯特捷利康也是這麼認為的。

And your next question comes from the line of Geoff Meacham from Bank of America.

你的下一個問題來自美國銀行的傑夫‧米查姆。

Murdo, I feel like I asked this one a lot, but on Aimovig, what do you think it will take for this product to really break out? I mean, I get it, it's growing on units, but for a new product that looks range bound, is there a meaningful negotiation with -- renegotiation with payers like you guys did with Repatha that's going to be required? Or what do you think it could take?

Murdo，我覺得這個問題我問過很多次了，但關於Aimovig，你認為這款產品真正取得突破需要什麼條件？我的意思是，我知道它的銷量正在成長，但對於一款看起來發展受限的新產品來說，是否需要像你們之前與Repatha那樣，與支付方進行有意義的談判——或者重新談判？還是你認為還需要做些什麼？

Yes. Thanks, Geoff. Let's narrow or reframe the question. I don't think it's a payer issue. I think we've negotiated very good access for Aimovig. It's covered broadly with very little in the way of utilization management criteria. Physician requests are being filled very well. Our percentage of paid patients is very high now. We're in the high 80% range for paid patients. So it's not an access restriction that's reducing the uptick of the class.

是的，謝謝，傑夫。我們來縮小或重新表達這個問題。我認為這不是支付方的問題。我認為我們已經為Aimovig爭取到了非常好的准入條件。它的醫保覆蓋範圍很廣，幾乎沒有使用管理方面的限制。醫生的申請也得到了很好的滿足。我們現在的付費患者比例非常高，接近80%。所以，並非是准入限制導致該類藥物使用量成長放緩。

There are really 2 things. One is obvious, it's COVID. We are down substantially in new patients per week because of COVID, and a lot of migraine sufferers, unfortunately, are just not seeking care. And neurology as a prescribing specialty is down more than some others, like cardiology recovered nicely in the quarter. Neurology is still down in terms of total prescribing. And that's the COVID impact.

實際上有兩個原因。一個顯而易見，那就是新冠疫情。由於疫情，我們每週新增患者數量大幅下降，許多偏頭痛患者很不幸地因此沒有就醫。神經科作為處方專科，其下降幅度比其他一些專科更大，例如心臟科在本季度已經明顯回升。神經科的處方總量仍然下降。這就是新冠疫情的影響。

And then there's another, I think, opportunity, which we're focused on, and that is to have both neurologists and patients moving quicker through older, less effective preventative agents and to try biologic CGRPs like Aimovig. And that's really where our focus is for growth. We've seen movement there, and it was going well. But we've got -- we've still got a lot of work to do, as you point out. But we've got a large volume of patients, over 4 million. I think we're 15% penetrated into that patient population. So there's really no doubt in my mind that it will move.

我認為還有另一個機遇，也是我們目前關注的重點，那就是讓神經科醫生和患者更快地擺脫療效較差的老舊預防藥物，轉而嘗試像Aimovig這樣的生物製劑CGRP。這才是我們真正關注的成長點。我們已經看到了這方面的進展，而且進展順利。但正如您所指出的，我們還有很多工作要做。不過，我們擁有龐大的患者群體，超過400萬人。我認為我們已經滲透到其中15%的患者群體。所以我毫不懷疑，它一定會發展壯大。

I also think, by the way, the oral CGRPs are helping here with the promotional effort, communication to patients, awareness building of the benefits of the category. So their acute promotion is also helping in the preventive space. But yes, we're focused on that. I think we've done all the right things on the communication front to payers. Now we're focused on patients and -- providers and patients.

順便說一句，我認為口服CGRPs也有助於推廣工作、與患者溝通以及提高人們對這類藥物益處的認識。因此，它們在急性期的推廣也有助於預防領域。是的，我們正專注於此。我認為我們在與支付方溝通方面已經做得非常到位。現在，我們的重點是病人以及醫護人員。

And your next question comes from the line of Kennen MacKay from RBC Capital.

你的下一個問題來自加拿大皇家銀行資本市場 (RBC Capital) 的 Kennen MacKay。

Congrats on the quarter. Wondering or hoping, rather, that you could set the record straight for plans with omecamtiv mecarbil. Are there plans to pursue a regulatory filing for the agent? And if so, what is the gating factor?

恭喜您取得季度佳績。我很想知道（或希望）您能否澄清一下關於omecamtiv mecarbil的計劃。是否有計劃向監管機構提交該藥物的申請？如果有，目前的阻礙因素是什麼？

Thanks, Ken. I'll take that. With omecamtiv, we issued the top line results. We've got data coming out at the American Heart Association in just a couple of weeks. And I think in the wake of that, we'll be discussing next steps.

謝謝，肯。我明白了。關於omecamtiv，我們已經公佈了初步結果。幾週後，我們將在美國心臟協會會議上公佈相關數據。我想在那之後，我們會討論下一步的計劃。

And your next question comes from the line of Umer Raffat from Evercore ISI.

你的下一個問題來自 Evercore ISI 的 Umer Raffat。

I had two here, if I may. First, I know there's a lot of focus on the durational response data as it's evolving in your Phase I and Phase II trial with KRAS. But my question is, as we think about 1 step out in a possible first-line setting, possibly as a PD-1 combination, we know what KEYTRUDA does as a first-line regimen on a duration of treatment and duration response. I'm curious, what's your expectation that KEYTRUDA paired with a targeted therapy, how much improvement can we see realistically? That will be very helpful, number one.

我有兩個問題，請容許我問一下。首先，我知道目前大家都在關注您KRAS標靶治療I期和II期臨床試驗中持續緩解的數據。但我的問題是，當我們考慮KEYTRUDA作為一線治療方案（例如與PD-1抑制劑聯合用藥）時，我們已經了解了KEYTRUDA作為一線治療方案在治療持續時間和緩解持續時間方面的表現。我很好奇，您對KEYTRUDA合併標靶治療的預期是什麼？我們實際上能看到多大的療效提升？這對我來說非常重要，這是第一點。

And also on that same note, as we head into the colorectal data in the first half, knowing that there were, I think, 3 out of 25 responses in colorectal previously. What are your expectations on what we need to see to be more constructive on colorectal?

同樣地，在進入上半部結直腸癌數據時，我們知道先前25例大腸癌病例中只有3例得到了回應。您認為我們需要看到哪些資訊才能對大腸癌做出更有建設性的判斷？

Yes. Thanks, Umer. So in terms of duration of response in moving in earlier lines of therapy, it's very clear what the checkpoint inhibitors do. I mean, typically, you're going to look for 25%, 30% improvements on these sorts of efficacy measures to get into the clinically meaningful range. So as we're designing programs, those are the sorts of targets that we would generally look at.

是的，謝謝，Umer。就早期治療方案的療效持續時間而言，免疫檢查點抑制劑的作用非常明確。我的意思是，通常情況下，這類療效指標的改善幅度在25%到30%之間，才能達到具有臨床意義的範圍。因此，在設計治療方案時，這些是我們通常會關注的目標。

In colorectal cancer, as I've mentioned before, we fully enrolled the Phase II trial data next year. That will inform a potential monotherapy path forward. I would want to see response rates perhaps a little better than we've observed now for monotherapy, but that will be a discussion with folks in the field. And here, I would say there's also just a huge amount of emphasis on combination therapy to both enhance the response rate and then, of course, to generate duration of response. As I mentioned earlier, we've got a number of combination trials, either up and running or about to launch, and some of them are directed specifically for colorectal cancer. So we're really looking forward to generating those data. But I think that's the kind of state of play right now.

正如我之前提到的，在結直腸癌領域，我們明年將完成第二期臨床試驗的整個受試者招募。這將為潛在的單藥治療方案提供參考。我希望單藥治療的緩解率能比目前觀察到的略高一些，但這需要與業內專家進行討論。此外，我認為目前非常重視聯合治療，旨在提高緩解率並延長緩解持續時間。正如我之前提到的，我們有許多聯合治療試驗正在進行或即將啟動，其中一些是專門針對結直腸癌的。因此，我們非常期待獲得這些數據。但我認為這就是目前的現狀。

And your next question comes from the line of Alethia Young from Cantor Fitzgerald.

你的下一個問題來自坎托·菲茨杰拉德的阿萊西亞·楊的詩句。

Congrats on the quarter and the progress. Can you just talk a little bit about Otezla and what you've seen in light of maybe COVID-19? Would it be an oral? And I know there's more kind of marketing, I guess, on the television, just wanted to get your outlook on price and kind of the volume over the next 12 months?

恭喜您本季的進展。您能否簡單談談Otezla，以及您在新冠疫情背景下的觀察？它會是口服藥物嗎？我知道現在電視上有很多廣告，我想了解您對未來12個月的價格和銷售有何看法？

Yes. Thanks, Alethia. We've been pleased with Otezla. We continue to see all of our integration activities of bringing that product in, being smooth, uneventful, largely now under the management of Amgen employees around the world. And the field force continues to really do an outstanding job of making sure dermatologists understand the benefits of Otezla in the treatment of psoriasis and psoriatic arthritis. I think what we've seen in the quarter is a return to customer activity, largely about 90% of pre-COVID levels. The majority of those customer interactions are in the virtual realm about 60% of those.

是的，謝謝，Alethia。我們對Otezla的表現非常滿意。我們看到，產品的整合工作進展順利，一切順利，目前主要由安進全球員工負責。銷售團隊也繼續出色地完成了工作，確保皮膚科醫生了解Otezla在治療銀屑病和銀屑病關節炎方面的益處。我認為，本季我們看到客戶活動已基本恢復到疫情前水準的90%左右。其中，約60%的客戶互動是透過線上方式進行的。

I think, overall, we're pleased with the growth in volume in the quarter. We did see some onetime events, accounting adjustments. We had a favorable accounting adjustment in 2019 in Q3 and an unfavorable accounting adjustment in Q3 this year, creating an unfavorable compare quarter-over-quarter from prior year. And we are also seeing a bit of softness in the dermatology prescribing volume year-on-year on the basis of COVID. But I think the differentiation of having an oral versus biologics versus topicals in psoriasis is really helping us hold up well. And we continue to feel confident about our double-digit growth going forward.

總的來說，我對本季銷售成長感到滿意。我們確實遇到了一些一次性事件和會計調整。 2019年第三季我們經歷了一次有利的會計調整，而今年第三季則經歷了一次不利的會計調整，導致本季環比低於去年同期水準。此外，受新冠疫情影響，皮膚科處方量較去年同期略有下降。但我認為，在乾癬治療領域，口服藥物、生物製劑和外用藥物的差異化優勢確實幫助我們維持了良好的表現。我們對未來兩位數的成長仍然充滿信心。

We've also held price nicely as we go into 2021. That's a good effect of having a differentiated product. And then overall, I think as we look at sources of growth throughout the world, our international expansion plans have been going well. We secured reimbursement in Australia. Our Japanese business really is doing well, and we're looking at reimbursement and market authorization in other markets. So overall, it's been a really good growth story for us, and we continue to feel good about the future. And then we'll wait patiently to see if we're able to secure a mild to moderate indication next year because I think that's a patient population that could really benefit from the convenience of an oral and the safety profile that we've established of Otezla versus, say, more potent orals or even biologics.

進入2021年，我們的價格也維持得相當不錯。這得歸功於我們產品的差異化優勢。總的來說，我認為，當我們審視全球成長點時，我們的國際擴張計畫進展順利。我們已在澳洲獲得健保報銷。我們在日本的業務表現也十分出色，我們正在尋求其他市場的醫保報銷和上市許可。因此，總體而言，我們的成長勢頭非常強勁，我們對未來充滿信心。接下來，我們將耐心等待，看看明年能否獲得輕度至中度適應症的批准，因為我認為這類患者群體能夠真正受益於口服藥物的便利性以及我們已證實的Otezla的安全性，相比之下，Otezla的效力更強，甚至優於生物製劑。

And your next question comes from the line of Cory Kasimov from JPMorgan.

你的下一個問題來自摩根大通的科里·卡西莫夫。

Wanted to follow-up on Otezla and ask about your baseline assumptions for TYK2, just given the proximity of that data in psoriasis. Those results are roughly consistent with the Phase II data that's been published. How do you think about this potentially slotting into the market and the potential impact it may or may not have on the future trajectory of Otezla? And can you remind us whether the double-digit CAGR expectation you put out there for Otezla contemplates U.S. competition?

我想就Otezla進行後續跟進，並詢問您對TYK2的基線假設，因為該數據在銀屑病領域與Otezla的數據非常接近。這些結果與已發表的II期數據大致一致。您如何看待該藥物進入市場的可能性，以及它可能對Otezla未來發展軌跡產生的影響？另外，您能否提醒我們，您先前對Otezla兩位數複合年增長率的預期是否考慮了美國市場的競爭？

Yes. So I'll answer your second part of your question first, Cory. The double-digit growth assumptions that we put out there did indeed assume the launch of other orals into the U.S. in a relatively similar time frame as to what's been publicly disclosed. I think, overall, as I was saying earlier, we feel really good about the position of Otezla in the market. It's a widely reimbursed product with really good market access, an affordable product from a patient perspective, very safe product from an overall profile perspective. And I just think that new entrants into the category will not necessarily differentiate on efficacy or on safety right out of the gate. I think it's going to take some time before dermatologists who are, quite frankly, leary of potent biologics for other products that might have efficacy, but they might travel with some safety concerns, and that's not the case with Otezla.

是的。那麼，Cory，我先回答你問題的第二部分。我們先前給出的兩位數成長預期，確實是基於其他口服製劑會在美國以與已公開披露的時間框架大致相同的速度上市的前提。總的來說，正如我之前所說，我們對Otezla的市場地位非常有信心。它是一款報銷範圍廣、市場准入性好、價格合理（從患者角度來看）且安全性極高的產品。我認為，新進入該領域的產品未必能在療效或安全性方面立即脫穎而出。坦白說，皮膚科醫師對強效生物製劑持謹慎態度，他們更傾向於選擇其他可能有效但有安全隱患的產品，而Otezla則不存在這些問題。

So this familiarity with Otezla, the unique positioning of it being the first product they go to post topical and pre biologic I think is going to hold up really well, and we continue to invest. We continue to invest heavily. Somebody mentioned they noticed more television advertising. We have ramped up DTC, given COVID is somewhat disrupting patient behavior. And also in light of COVID, there are a lot of products in this category that require lab monitoring, and Otezla doesn't. So a really good profile, and I think one that will hold up well despite competition.

因此，人們對Otezla的熟悉程度，以及它作為局部用藥後、生物製劑前首選藥物的獨特定位，我認為將保持良好的市場地位，我們也將繼續加大投入。有人提到他們注意到電視廣告增加。鑑於新冠疫情在某種程度上影響了患者的用藥行為，我們已加強了直接面向消費者的行銷。此外，考慮到新冠疫情的影響，該類別中的許多產品都需要實驗室監測，而Otezla則不需要。因此，Otezla擁有非常優秀的市場定位，我認為即使面對激烈的競爭，它也能保持良好的市場地位。

April it's getting to the top of the hour, so let's take one more question, after which Bob will make some closing comments.

四月，現在已經快到整點了，所以我們再回答一個問題，之後鮑伯將作總結發言。

And your last question will come from the line of Robyn Karnauskas from Truist Securities.

最後一個問題將來自 Truist Securities 的 Robyn Karnauskas。

I'll stay on Otezla. So I know that the current topicals are not ideal with the side effect profile. I wondered if you could comment on the recent data for [Pineros] with a PASI score that looked on par with Otezla. And my specific question is more what percentage of Otezla use is with low surface involvement patients? And do you see these new topicals that are coming out potentially disruptive on a share or price basis?

我將繼續使用奧特茲拉（Otezla）。我知道目前外用藥物的副作用並不理想。我想請您談談最近關於皮內羅斯（Pineros）的數據，它的PASI評分看起來與奧特茲拉相當。我的具體問題是，奧特茲拉的使用人群中，有多少比例是用於治療皮損面積較小的患者？您認為即將上市的這些新型外用藥物是否會對市佔率或價格產生顛覆性影響？

Yes. Thanks, Robyn. We really see these as unique segments of the market. The topical segment doesn't necessarily compete with the oral segment. We do see -- right now, we do see some low surface area usage. But I think as we look at our mild to moderate indication in the future, I think there would be more potential overlap with say, let's say, more effective topicals for low surface areas and orals. But it's really -- it's not impeding our ability to grow, and I don't see them as overlapping sectors. I think when patients say they want the convenience of an oral, it's a very clear choice to go to Otezla.

是的，謝謝，Robyn。我們確實認為這些是獨特的市場區隔。外用製劑並非必然與口服製劑構成競爭關係。目前，我們確實看到一些小面積的使用。但我認為，展望未來，當我們專注於輕度至中度適應症時，它與一些更有效的局部用藥（例如用於小面積的口服製劑）之間可能會有更多潛在的重疊。但這實際上並沒有阻礙我們的成長，而且我認為它們並非重疊的領域。我認為，當患者表示他們想要方便的口服藥物時，選擇Otezla是一個非常明確的選擇。

Bob, would you like to make any short comment?

鮑勃，你有什麼簡短的發言嗎？

Sure. Briefly just with 9 or so weeks left in the year. We're encouraged that we continue to execute well. I think you see that in the numbers and in the progress that we're making in our market shares and in our pipeline. But we know that this is a year unlike any other. So we're trying to be prudent as we look at the balance of the year and the beginning of next year, particularly as regards to the risks posed by COVID-19. So we appreciate you joining our call. We look forward to seeing you or speaking to you in the new year. And in the meantime, Arvind and his team are here for any questions that you might have. Thank you.

當然。簡單來說，今年還剩大約9週時間。我們很高興能夠繼續保持良好的執行力。我想您能從我們的數據以及市場份額和產品線進展中看出這一點。但我們也知道，今年與往年截然不同。因此，在展望今年剩餘時間和明年年初時，我們會謹慎行事，尤其要考慮到新冠疫情帶來的風險。感謝您參加我們的電話會議。我們期待在新的一年與您見面或交流。同時，Arvind和他的團隊隨時準備好解答您的任何問題。謝謝。

Thank you, everybody.

謝謝大家。

Ladies and gentlemen, this concludes Amgen's Third Quarter 2020 Financial Results Conference Call. You may now disconnect.

女士們、先生們，安進公司2020年第三季財務業績電話會議到此結束。您可以斷開連線了。