禮來公司 (LLY) 2020 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to Lilly's Q3 2020 Earnings Call.

女士們，先生們，感謝你們的支持，歡迎來到禮來公司 2020 年第三季度財報電話會議。

(Operator Instructions) And as a reminder, your conference is being recorded.

（操作員說明）作為提醒，您的會議正在錄製中。

I would now like to turn the conference over to your host, Mr. Kevin Hern.

我現在想將會議轉交給您的主持人 Kevin Hern 先生。

Please go ahead.

請繼續。

Good morning.

早上好。

Thank you for joining us for Eli Lilly and Company's Q3 2020 Earnings Call.

感謝您參加禮來公司 2020 年第三季度財報電話會議。

I'm Kevin Hern, Vice President of Investor Relations.

我是投資者關係副總裁 Kevin Hern。

Joining me on today's call are Dave Ricks, Lilly's Chairman and CEO; Josh Smiley, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific Officer; Anne White, President of Lilly Oncology; Patrik Jonsson, President of Lilly USA; Mike Mason, President of Lilly Diabetes; and Ilya Yuffa, President of Lilly Bio-Medicines.

與我一起參加今天電話會議的還有禮來公司董事長兼首席執行官戴夫·里克斯（Dave Ricks）；喬什·斯邁利，首席財務官； Dan Skovronsky 博士，首席科學官；禮來腫瘤學總裁 Anne White；禮來美國公司總裁帕特里克·瓊森（Patrik Jonsson）；禮來糖尿病總裁 Mike Mason；和禮來生物醫藥總裁 Ilya Yuffa。

We're also joined by Sara Smith and Mike Czapar of the Investor Relations team.

投資者關係團隊的 Sara Smith 和 Mike Czapar 也加入了我們的行列。

During this conference call, we anticipate making projections and forward-looking statements based on our current expectations.

在這次電話會議期間，我們預計會根據我們目前的預期做出預測和前瞻性陳述。

Our actual results could differ materially due to a number of factors, including those noted on Slide 3. Additional information concerning factors that could cause actual results to differ materially is contained in Lilly's latest Form 10-K and subsequent Forms 10-Q and 8-K.

由於多種因素，我們的實際結果可能存在重大差異，包括幻燈片 3 中指出的因素。有關可能導致實際結果存在重大差異的因素的其他信息包含在禮來公司最新的 10-K 表格和後續 10-Q 和 8- 表格中K。

The information we provide about our products and pipeline is for the benefit of the investment community.

我們提供的有關我們的產品和管道的信息是為了投資界的利益。

It is not intended to be promotional and is not sufficient for prescribing decisions.

它不是為了促銷，也不足以做出處方決定。

As we transition to our prepared remarks, I'll remind you that our commentary will focus on non-GAAP financial measures, which exclude the financial contribution from Elanco during 2019, and present earnings per share as though the full disposition via the exchange offer was complete on January 1, 2019.

當我們過渡到我們準備好的評論時，我會提醒您，我們的評論將集中在非公認會計準則財務指標上，其中不包括 Elanco 在 2019 年的財務貢獻，並呈現每股收益，就好像通過交換要約的全部處置是於 2019 年 1 月 1 日完成。

Now I'll turn the call over to Dave for some opening comments.

現在，我將把電話轉給 Dave，以徵求一些開場白。

Thanks, Kevin.

謝謝，凱文。

Q3 was another important quarter for Lilly and the pharmaceutical industry's progress in developing new medicines to treat COVID-19.

第三季度是禮來公司和製藥行業在開發治療 COVID-19 的新藥方面取得進展的另一個重要季度。

I'm very proud of Lilly's work.

我為莉莉的工作感到非常自豪。

And we'll go into detail of the promising advancements made this quarter.

我們將詳細介紹本季度取得的有希望的進步。

However, I'd like to start by summarizing our overall business performance.

不過，我想首先總結一下我們的整體業務表現。

Clearly, this quarter's financial results came in below sell-side analyst projections.

顯然，本季度的財務業績低於賣方分析師的預測。

While we don't provide quarterly guidance, I'll make a few high-level comments on several factors that did impact our Q3 results.

雖然我們不提供季度指導，但我將對確實影響我們第三季度業績的幾個因素發表一些高層評論。

And then Josh will go into more detail later.

然後 Josh 稍後會詳細介紹。

First, as we've seen -- as we've discussed in the past, the impact of price on revenue can be volatile in the U.S. as we make estimates for rebates and discounts, obligations during the coverage gap of Medicare Part D patient assistance programs and other liabilities.

首先，正如我們所看到的——正如我們過去所討論的，價格對收入的影響在美國可能是不穩定的，因為我們會估計回扣和折扣，以及在醫療保險 D 部分患者援助的覆蓋缺口期間的義務計劃和其他負債。

During Q3, the magnitude of adjustments was meaningful, predominantly related to our assumptions regarding our obligation during the coverage gap in Medicare Part D for Trulicity.

在第三季度，調整幅度是有意義的，主要與我們在醫療保險 D 部分中為 Trulicity 的承保缺口期間的義務有關的假設有關。

While the impact was notable in Q3, this source of volatility normalizes when analyzing our results over the first 9 months as well as for the full year.

雖然第三季度的影響很明顯，但在分析我們前 9 個月以及全年的結果時，這種波動性來源會正常化。

In addition, while we are encouraged new prescriptions are trending toward pre-COVID levels, the recovery varies by class.

此外，雖然我們鼓勵新處方趨向於 COVID 之前的水平，但恢復情況因類別而異。

We view this important -- this impact as transient.

我們認為這很重要——這種影響是短暫的。

We remain confident in the underlying business and continue to manage our operations to deliver success over the long term.

我們對基礎業務仍然充滿信心，並繼續管理我們的運營以實現長期成功。

From an operating expense standpoint, we made significant investments in R&D to develop COVID-19 treatments.

從運營費用的角度來看，我們在研發方面進行了大量投資以開發 COVID-19 治療方法。

While we've spoken before about our efforts to develop COVID-19 treatments, we've not quantified that investment level.

雖然我們之前曾談到我們開發 COVID-19 治療的努力，但我們尚未量化投資水平。

In Q3, we were fortunate to see positive clinical data from multiple trials.

在第三季度，我們有幸看到多項試驗的積極臨床數據。

And this activity had an impact of about $0.12 on Q3 earnings per share.

這項活動對第三季度每股收益產生了約 0.12 美元的影響。

Finally, after taking a pause on active promotion in Q2 to respect the impact that COVID-19 had on medical practices, we increased our investments in customer-facing activity and direct-to-consumer marketing in Q3 in order to accelerate our growth.

最後，在第二季度暫停積極促銷以尊重 COVID-19 對醫療實踐的影響後，我們在第三季度增加了對面向客戶的活動和直接面向消費者的營銷的投資，以加速我們的增長。

While this did create a step-up compared to our investment level and SG&A in Q2 2020 and versus Q3 2019, we believe our progress in Q3 sets us up for a strong finish to the year and to provide meaningful momentum into 2021.

雖然與我們在 2020 年第二季度和 2019 年第三季度的投資水平和 SG&A 相比，這確實創造了一個進步，但我們相信，我們在第三季度的進展為我們在今年取得強勁的成績奠定了基礎，並為 2021 年提供了有意義的動力。

We have a number of opportunities to drive this growth through these investments in our existing commercial portfolio.

我們有許多機會通過對我們現有商業投資組合的這些投資來推動這種增長。

These include our unique CV indication for Trulicity and the recently launched higher doses; pulling through access wins for Taltz and launching the recently approved non-radiographic axSpa indication; and driving increased uptake of Verzenio through our differentiated data package, just to highlight a few.

其中包括我們獨特的 Trulicity CV 適應症和最近推出的更高劑量；拉動 Taltz 的准入勝利，並推出最近批准的非射線 axSpa 指示；並通過我們差異化的數據包推動 Verzenio 的增加，僅舉幾例。

Looking at the underlying trends in Q3.

著眼於第三季度的潛在趨勢。

We delivered revenue growth of 5% or 4%, excluding the impact of foreign exchange.

剔除外匯影響，我們實現了 5% 或 4% 的收入增長。

Despite disruptions on new patient starts from the global pandemic, volume growth was solid, increasing by 9% versus Q3 2019.

儘管全球大流行對新患者的開始造成乾擾，但銷量增長穩健，與 2019 年第三季度相比增長了 9%。

Our key growth products continue to be the catalyst for our business performance and made up over half of our revenue during the quarter.

我們的主要增長產品繼續成為我們業務表現的催化劑，占我們本季度收入的一半以上。

International performance in Europe and China was particularly strong as constant currency revenue grew 9% and 10%, respectively, driven by our newest products.

歐洲和中國的國際表現尤其強勁，在我們最新產品的推動下，固定貨幣收入分別增長了 9% 和 10%。

For the first 9 months of the year, our revenue grew by 6% driven by 12% volume growth.

今年前 9 個月，在銷量增長 12% 的推動下，我們的收入增長了 6%。

This growth was delivered during a period of significant disruption.

這種增長是在重大中斷期間實現的。

The ways we launch new medicines, execute clinical trials and manufacture our products have all been meaningfully changed during the pandemic, with some adjustments likely to remain as our business continues to evolve.

在大流行期間，我們推出新藥、執行臨床試驗和製造產品的方式都發生了重大變化，隨著我們業務的不斷發展，一些調整可能仍然存在。

We are proud of our efforts to ensure patients have access to medicines by maintaining our manufacturing plants and continuous operation and by developing potential new treatments for COVID-19.

我們為通過維持我們的製造工廠和持續運營以及為 COVID-19 開發潛在的新療法來確保患者能夠獲得藥物而做出的努力感到自豪。

Operating margin as a percent of revenue was 26.2% for the third quarter.

第三季度營業利潤率佔收入的百分比為 26.2%。

This is a decline of 230 basis points versus Q3 2019 but was depressed by $125 million that we invested in COVID-19 therapies during the quarter.

這與 2019 年第三季度相比下降了 230 個基點，但由於我們在本季度投資於 COVID-19 療法的 1.25 億美元而受到抑制。

Excluding these exceptional activities, operating margin was 28.4%.

排除這些特殊活動，營業利潤率為 28.4%。

We have confidence in our outlook and expect to deliver financial results within our updated guidance range, with all lines at or above our original 2020 guidance and to achieve our operating margin expansion plans, excluding our investments in COVID-19 treatments.

我們對我們的前景充滿信心，並期望在我們更新的指導範圍內實現財務業績，所有產品線都達到或高於我們最初的 2020 年指導，並實現我們的營業利潤率擴張計劃，不包括我們對 COVID-19 治療的投資。

The fundamentals of our business are strong.

我們業務的基礎是強大的。

And we remain well positioned for a period of sustained growth and margin expansion.

在一段持續增長和利潤率擴張的時期，我們仍然處於有利地位。

Turning to the pipeline.

轉向管道。

In Q3, we made meaningful progress advancing our late-stage pipeline and developing potential COVID-19 treatments, including FDA approval of additional doses for Trulicity for the treatment of type 2 diabetes; an important data readout for Verzenio in early breast cancer; approval in Europe for Olumiant in adults with moderate to severe atopic dermatitis; positive Phase III results from the ACTT-2 trial of baricitinib in combination with remdesivir in hospitalized COVID-19 patients; positive results of our COVID-19 neutralizing antibody monotherapy in combination therapies; and we presented new data on a potential new indication for Jardiance in collaboration with Boehringer Ingelheim.

在第三季度，我們在推進後期管道和開發潛在的 COVID-19治療方面取得了有意義的進展，包括 FDA 批准 Trulicity 用於治療 2 型糖尿病的額外劑量； Verzenio 在早期乳腺癌中的重要數據讀數；在歐洲批准用於成人中度至重度特應性皮炎的 Olumiant；巴瑞克替尼聯合瑞德西韋在住院 COVID-19 患者中的 ACTT-2 試驗的 III 期陽性結果；我們的 COVID-19 中和抗體單一療法在聯合療法中的積極結果；我們與勃林格殷格翰合作提供了有關 Jardiance 潛在新適應症的新數據。

I'm encouraged by our company's efforts to develop potential new therapies to treat COVID-19 and working at unprecedented speed.

我們公司努力開發治療 COVID-19 的潛在新療法並以前所未有的速度開展工作，這讓我感到鼓舞。

This work would not have been possible without the tireless efforts of many employees of Lilly and the collaborative efforts across the industry, regulators and government.

如果沒有禮來公司許多員工的不懈努力以及整個行業、監管機構和政府的共同努力，這項工作是不可能完成的。

We continue to utilize external innovation and collaboration to augment our internal capabilities.

我們繼續利用外部創新和協作來增強我們的內部能力。

This quarter, we signed a number of business development transactions, including the global expansion of our TYVYT collaboration with Innovent.

本季度，我們簽署了多項業務發展交易，包括我們與 Innovent 的 TYVYT 合作的全球擴張。

At the same time, we utilized our strong cash flow to return nearly $700 million to shareholders via the dividend.

同時，我們利用強勁的現金流通過股息向股東返還了近 7 億美元。

Moving to Slides 5 and 6, you'll see the full list of key events since our last earnings call.

轉到幻燈片 5 和 6，您將看到自上次財報電話會議以來關鍵事件的完整列表。

I would like to welcome Ilya Yuffa to our executive team as he assumes leadership for our Bio-Medicines business unit; a 25-year veteran with a tremendous breadth of experience across our organization, from finance, business development and sales to Six Sigma, ethics and compliance and general management.

我想歡迎 Ilya Yuffa 加入我們的執行團隊，他將領導我們的生物醫藥業務部門；一位擁有 25 年經驗的資深人士，在我們的組織中擁有豐富的經驗，從財務、業務發展和銷售到六西格碼、道德和合規以及一般管理。

Ilya has consistently delivered impressive results in successful larger roles that -- successively larger roles, which have prepared him well to lead Lilly Bio-Medicines.

Ilya 一直在成功的更大角色中取得令人印象深刻的成果 - 連續更大的角色，這使他做好了領導 Lilly Bio-Medicines 的準備。

After serving as General Manager of Italy since 2018, Ilya has been leading Lilly's largest franchise, U.S. Diabetes, where he played a critical role in the continued success of the market-leading medicine, Trulicity, as well as Jardiance in the 2 fastest-growing classes in diabetes.

自 2018 年起擔任意大利總經理後，Ilya 一直領導禮來最大的特許經營公司美國糖尿病，他在市場領先藥物 Trulicity 和 Jardiance 在增長最快的 2糖尿病課程。

Ilya, it's great to have you on our leadership team.

Ilya，很高興你加入我們的領導團隊。

I'd also like to thank Patrik for his energy, focus and execution that he brought to his time as President of Lilly Bio-Medicines.

我還要感謝 Patrik 在擔任禮來生物醫藥總裁期間所付出的精力、專注和執行力。

Given Patrik's strong record of successfully managing Lilly businesses in complex markets around the world, he is the right enterprise leader to lead Lilly USA and our global customer-focused functions during this exciting period of opportunity and growth as we look to continue to deliver new medicines to patients.

鑑於 Patrik 在全球複雜市場中成功管理禮來業務的良好記錄，他是領導禮來美國公司和我們以客戶為中心的全球職能部門的合適企業領導者，在這個激動人心的機遇和增長時期，我們希望繼續提供新藥給患者。

Before I turn the call over to Josh to review our Q3 results and to provide an update on our financial guidance for 2020, I want to discuss briefly certain events at one of our manufacturing facilities located in Branchburg, New Jersey.

在我將電話轉給喬什以審查我們的第三季度業績並提供我們 2020 年財務指導的最新信息之前，我想簡要討論一下我們位於新澤西州布蘭奇堡的製造工廠中的某些事件。

Late last year, our Branchburg plant underwent a routine FDA general surveillance inspection.

去年年底，我們的 Branchburg 工廠接受了 FDA 的常規監督檢查。

The inspectors identified findings related to data handling, and we received an official action-indicated notice as well as a follow-up inspection this year.

檢查員發現了與數據處理有關的發現，我們今年收到了正式的行動指示通知以及後續檢查。

We have not received a warning letter or other enforcement letter from the FDA at this time.

我們目前尚未收到 FDA 的警告信或其他強制執行信。

Given that this plant is among several worldwide that produces bamlanivimab or Lilly SARS-CoV555, one of our COVID-19 neutralizing antibodies, I want to share more information about our response to these inspections.

鑑於該工廠是世界範圍內生產 bamlanivimab 或 Lilly SARS-CoV555（我們的一種 COVID-19 中和抗體）的工廠之一，我想分享更多關於我們對這些檢查的反應的信息。

First, we are confident the issues raised during the inspections did not impact product quality or patient safety for bamlanivimab or for any other product manufactured at the Branchburg plant.

首先，我們相信檢查期間提出的問題不會影響 bamlanivimab 或 Branchburg 工廠生產的任何其他產品的產品質量或患者安全。

Having said that, we and I take remediation of these data handling issues and our commitment to quality and safety very seriously.

話雖如此，我們和我都非常重視這些數據處理問題的補救措施以及我們對質量和安全的承諾。

We engaged an external firm to conduct a comprehensive independent review of systems at the Branchburg site, and we are working diligently to incorporate suggestions for improvement to our procedures.

我們聘請了一家外部公司對 Branchburg 站點的系統進行全面的獨立審查，我們正在努力將改進建議納入我們的程序。

We have also had this firm perform independent reviews of our manufacturing of bamlanivimab at Branchburg to examine our manufacturing batch records and quality documentation to corroborate our own batch release decisions as we submit for supply of bamlanivimab from Branchburg for the Emergency Use Authorization we requested.

我們還讓這家公司對我們在 Branchburg 的 bamlanivimab 製造進行了獨立審查，以檢查我們的製造批次記錄和質量文件，以證實我們自己的批次放行決定，因為我們從 Branchburg 提交 bamlanivimab 供應以獲得我們請求的緊急使用授權。

We are confident in the material at this facility and, frankly, at all of our sites.

我們對這家工廠的材料充滿信心，坦率地說，在我們所有的網站上都是如此。

Finally, for our neutralizing antibodies, we have a robust global supply chain in place with 5 active ingredient manufacturing sites worldwide in addition to 5 additional drug product sites worldwide.

最後，對於我們的中和抗體，我們擁有強大的全球供應鏈，除了全球 5 個額外的藥品生產基地外，我們還擁有全球 5 個活性成分生產基地。

Branchburg is one of the active ingredient sites.

Branchburg 是活性成分位點之一。

Once we are approved to do so, our resilient global network is well positioned to begin the supply as we help battle this global pandemic.

一旦我們被批准這樣做，我們有彈性的全球網絡就可以開始供應，因為我們幫助對抗這一全球流行病。

Now let me turn it over to Josh.

現在讓我把它交給喬希。

Thanks, Dave, and good morning, everyone.

謝謝，戴夫，大家早上好。

Moving to Slide 7 and 8, you will see our non-GAAP financial performance in Q3 and during the first 9 months of 2020.

轉到幻燈片 7 和 8，您將看到我們在第三季度和 2020 年前 9 個月的非公認會計原則財務業績。

As Dave mentioned, revenue increased 5% this quarter compared to Q3 2019 as key growth products drove volume growth.

正如戴夫所說，由於關鍵增長產品推動了銷量增長，本季度的收入與 2019 年第三季度相比增長了 5%。

Gross margin as a percent of revenue in Q3 was 79.1%, a decline of 50 basis points versus Q3 2019 driven primarily by the unfavorable effect of foreign exchange rates on international inventories sold and lower realized prices, partially offset by favorable manufacturing efficiencies and product mix.

第三季度毛利率佔收入的百分比為 79.1%，與 2019 年第三季度相比下降了 50 個基點，主要是由於匯率對國際銷售庫存的不利影響和較低的實際價格，部分被有利的製造效率和產品組合所抵消.

Moving down the P&L.

向下移動損益表。

Selling, general and administrative expenses increased 11% this quarter compared to Q3 2019 as we invested meaningfully in direct-to-consumer marketing to augment our virtual tactics, increasing promotion to physicians and consumers in connection with increases in health care utilization around the world.

與 2019 年第三季度相比，本季度的銷售、一般和管理費用增加了 11%，因為我們在直接面向消費者的營銷方面進行了有意義的投資，以增強我們的虛擬策略，隨著全球醫療保健利用率的提高，增加對醫生和消費者的推廣。

As I will discuss in our guidance in a few minutes, we see the absolute level of third quarter SG&A expenses as indicative of our fourth quarter expenditures as well, which keeps us on track for our full year ranges and modest full year growth.

正如我將在幾分鐘後在我們的指導中討論的那樣，我們認為第三季度 SG&A 費用的絕對水平也反映了我們第四季度的支出，這使我們保持在全年範圍內和全年適度增長的軌道上。

Research and development expenses increased by 6% in the quarter driven primarily by our efforts to develop COVID-19 neutralizing antibodies and baricitinib for hospitalized COVID-19 patients, partially offset by lower development expenses for late-stage assets.

本季度研發費用增長了 6%，主要是由於我們為住院 COVID-19 患者開發 COVID-19 中和抗體和巴瑞替尼的努力，部分被後期資產開發費用的降低所抵消。

In total, operating income decreased 4% compared to Q3 2019 as increased investments, including COVID-19-related R&D expenses, exceeded revenue growth during the quarter.

總體而言，營業收入與 2019 年第三季度相比下降了 4%，因為增加的投資（包括與 COVID-19 相關的研發費用）超過了該季度的收入增長。

We expect the increased marketing activity and customer activation to drive additional revenue growth going forward.

我們預計營銷活動和客戶激活的增加將推動未來的額外收入增長。

During the first 9 months of 2020, operating income increased by 7% as revenue growth outpaced operating expense growth.

在 2020 年前 9 個月，營業收入增長了 7%，因為收入增長超過了營業費用增長。

Operating income as a percent of revenue was 26.2% during the third quarter and 28.1% for the first 9 months of 2020.

第三季度營業收入佔收入的百分比為 26.2%，2020 年前 9 個月為 28.1%。

As Dave mentioned earlier, our investments in COVID-19 therapies represent an investment outside of our normal business operations.

正如 Dave 之前提到的，我們對 COVID-19 療法的投資代表了我們正常業務運營之外的投資。

So excluding R&D expenses of $180 million associated with these important programs, our operating margin during the first 9 months of 2020 would have been 29.2%.

因此，不包括與這些重要項目相關的 1.8 億美元研發費用，我們在 2020 年前 9 個月的營業利潤率為 29.2%。

And consistent with our guidance, we expect continued improvement in Q4.

並且與我們的指導一致，我們預計第四季度將繼續改善。

We continue to allocate resources efficiently in an environment where COVID-19 is likely to have an impact for a sustained period of time.

我們將繼續在 COVID-19 可能會持續一段時間內產生影響的環境中有效地分配資源。

We've made the transition to a hybrid virtual and in-person commercial model to support executing our strategy.

我們已經過渡到混合虛擬和麵對面商業模式，以支持執行我們的戰略。

And we're committed to margin expansion in 2020 and beyond.

我們致力於在 2020 年及以後擴大利潤率。

Other income and expense was income of $159 million this quarter compared to expense of $25 million in Q3 2019.

其他收入和支出為本季度的收入為 1.59 億美元，而 2019 年第三季度的支出為 2500 萬美元。

This quarter's other income was primarily driven by investment gains across our portfolio of public and private biopharm company investments as part of our external innovation strategy.

本季度的其他收入主要來自我們公共和私人生物製藥公司投資組合的投資收益，這是我們外部創新戰略的一部分。

As we regularly highlight, this line can be volatile as public and private equity valuations fluctuate.

正如我們經常強調的那樣，隨著公共和私募股權估值的波動，這條線可能會波動。

We've received quite a bit of investor feedback on this item.

我們收到了很多關於這個項目的投資者反饋。

So beginning in 2021, we will exclude the gains or losses due to equity investments from our non-GAAP measures.

因此，從 2021 年開始，我們將從我們的非公認會計原則指標中排除股權投資產生的收益或損失。

We believe this will better align our non-GAAP results with our core business operations, allow for easier comparisons with our peer group and remove unpredictable volatility.

我們相信這將更好地使我們的非公認會計原則結果與我們的核心業務運營保持一致，更容易與我們的同行進行比較，並消除不可預測的波動。

This quarter, our tax rate was 15.5%, an increase of 380 basis points compared with the same quarter last year driven by the mix of earnings in higher-tax jurisdictions and lower net discrete tax benefit this quarter versus the same quarter last year.

本季度，我們的稅率為 15.5%，與去年同期相比增加了 380 個基點，這是由於本季度稅收較高的司法管轄區的收益混合以及本季度與去年同期相比較低的淨離散稅收優惠。

While we expect some quarterly variability, we remain comfortable with long-term expectations of roughly 14% to 15% tax rate under the current U.S. corporate tax structure.

雖然我們預計會有一些季度波動，但我們仍然對在當前美國公司稅結構下大約 14% 至 15% 的稅率的長期預期感到滿意。

At the bottom line, earnings per share increased 4%.

最終，每股收益增長了 4%。

During the first 9 months of 2020, earnings per share increased 20%.

在 2020 年前 9 個月，每股收益增長了 20%。

On Slides 9 and 10, we describe the effect of price, rate and volume on revenue.

在幻燈片 9 和 10 中，我們描述了價格、費率和數量對收入的影響。

Worldwide revenue increased 5% during Q3 as volume growth of 9% was partially offset by price.

由於 9% 的銷量增長被價格部分抵消，第三季度全球收入增長了 5%。

Foreign exchange rates had a 1% positive impact on revenue growth.

外匯匯率對收入增長產生了 1% 的積極影響。

During the first 9 months of 2020, revenue grew 6% driven by volume growth of 12%.

2020 年前 9 個月，在銷量增長 12% 的推動下，收入增長了 6%。

Price was a 6% drag on worldwide growth or 4% if you exclude the impact of Alimta and TYVYT in China.

如果排除 Alimta 和 TYVYT 在中國的影響，價格對全球增長的影響為 6%，或為 4%。

U.S. revenue grew 3% compared to the third quarter of 2019.

與 2019 年第三季度相比，美國收入增長了 3%。

Volume growth of 7% was led by Trulicity, Taltz and Verzenio, partially offset by increased competition for Forteo and the impact on Trajenta from the restructuring of the BI alliance.

Trulicity、Taltz 和 Verzenio 引領了 7% 的銷量增長，部分被 Forteo 競爭加劇以及 BI 聯盟重組對 Trajenta 的影響所抵消。

In line with our expectations, price was a 4% drag on U.S. revenue growth.

與我們的預期一致，價格拖累了美國收入增長 4%。

3 percentage points were due to changes to estimates for rebates and discounts, most notably impacting Trulicity.

3 個百分點是由於對回扣和折扣的估計發生變化，對 Trulicity 的影響最為顯著。

1 percentage point was due to the net impact of increased rebates across the portfolio to maintain our strong commercial access, partially offset by modest list price increases.

1 個百分點是由於整個投資組合增加回扣以保持我們強大的商業准入的淨影響，部分被適度的標價上漲所抵消。

And while typically we do not discuss detailed pricing dynamics for individual products, I will provide some additional commentary on the impact of price on Trulicity performance in Q3.

雖然我們通常不會討論個別產品的詳細定價動態，但我將就價格對第三季度 Trulicity 業績的影響提供一些額外的評論。

In prior quarters, we assumed our Part D coverage gap liability would shift to later in the year due to short-term deferral of health care utilization caused by the impact of COVID-19 and the increased threshold for entry into the coverage gap.

在前幾個季度，我們假設我們的 D 部分覆蓋缺口責任將轉移到今年晚些時候，因為 COVID-19 的影響導致醫療保健利用的短期推遲以及進入覆蓋缺口的門檻增加。

However, informed by recent invoices from our Part D customers, we now anticipate similar patterns to prior years.

但是，根據我們 D 部分客戶最近的發票，我們現在預計與往年類似的模式。

So this resulted in updated estimates that led to a meaningful impact on Q3 results and a double-digit drag on Trulicity's growth rate.

因此，這導致了更新的估計，對第三季度的結果產生了有意義的影響，並對 Trulicity 的增長率造成了兩位數的拖累。

Our estimated coverage GAAP impact for the full year, though, is largely unchanged.

不過，我們估計的全年覆蓋範圍 GAAP 影響基本沒有變化。

Excluding the impact of the onetime adjustments, Trulicity's price declined by high single digits in the third quarter versus Q3 2019 and low double digits for the first 9 months of 2020.

排除一次性調整的影響，Trulicity 的價格在第三季度與 2019 年第三季度相比下降了高個位數，在 2020 年前 9 個月下降了兩位數。

We expect a high single-digit price decline for Trulicity for the full year.

我們預計 Trulicity 全年價格將出現個位數的高跌幅。

Last year, we guided toward a mid-single-digit price decline for Trulicity.

去年，我們引導 Trulicity 的價格下降了中個位數。

We expected this to be driven by increasing rebate rates to maintain our excellent access, partially offset by modest list price increases and modest growth in more highly rebated segments.

我們預計這將受到提高返利率的推動，以保持我們良好的准入，部分被適度的標價上漲和高返利細分市場的適度增長所抵消。

As 2020 has unfolded, the negative impact of price on Trulicity growth had been higher than we expected primarily due to segment mix.

隨著 2020 年的展開，價格對 Trulicity 增長的負面影響高於我們的預期，主要是由於細分市場。

On Slide 10, we show the impact of segment mix and rate on Trulicity growth in 2019 and 2020.

在幻燈片 10 中，我們展示了細分市場組合和比率對 2019 年和 2020 年 Trulicity 增長的影響。

While rate was a pricing headwind, the net impact of modest list price increases and increased rebate rates has been mid-single digits or lower, which is consistent with our expectations.

雖然費率是一個定價逆風，但適度的標價上漲和回扣率增加的淨影響一直在中個位數或更低，這與我們的預期一致。

Moving to segment mix.

轉向細分組合。

While the commercial segment continues to deliver robust growth, lower net price segments have grown significantly faster.

雖然商業部門繼續實現強勁增長，但淨價格較低的部門增長速度明顯更快。

This depressed Trulicity's reported growth by approximately 7 percentage points in 2019 and 6 percentage points through the first 9 months of 2020.

這使 Trulicity 報告的 2019 年增長下降了約 7 個百分點，到 2020 年前 9 個月下降了 6 個百分點。

This continued growth in 2020 exceeded our expectations and was primarily driven by Medicaid and, to a lesser extent, Medicare and other segments.

2020 年的持續增長超出了我們的預期，主要是由 Medicaid 以及在較小程度上由 Medicare 和其他部門推動的。

Within Medicaid, we experienced formulary changes in key states, faster-than-anticipated pull-through of access wins and expansion of total Medicaid lives this year.

在 Medicaid 中，今年我們經歷了關鍵州的處方變化、獲得勝利的速度快於預期以及 Medicaid 總生命的擴大。

Trulicity currently has a 45% share of market across all segments and continues to be the market-leading GLP-1.

Trulicity 目前在所有領域擁有 45% 的市場份額，並繼續成為市場領先的 GLP-1。

We exited Q3 with a similar share of market in the commercial segment.

我們在商業領域以相似的市場份額退出了第三季度。

However, consistent with volume growth, we gained 4.5 percentage points of share in Medicaid and other segments since Q1 2019 and finished the quarter at a 38% share of market.

然而，與銷量增長一致，自 2019 年第一季度以來，我們在醫療補助和其他領域的份額增加了 4.5 個百分點，並以 38% 的市場份額結束了本季度。

It's worth noting that utilization of GLP-1s as a class is still immature, and low market penetration suggests significant opportunity for additional growth across all segments.

值得注意的是，GLP-1 作為一個類別的使用仍然不成熟，市場滲透率低表明所有細分市場都有巨大的額外增長機會。

GLP-1s are used less in Medicaid and Medicare, and we expect disproportionate volume growth in these segments to continue.

GLP-1 在 Medicaid 和 Medicare 中的使用較少，我們預計這些領域的銷量將繼續不成比例地增長。

Although these volume gains have a lower realized price than our commercial business, they do represent profitable business and enable Trulicity to help more people living with diabetes.

儘管這些銷量增長的實際價格低於我們的商業業務，但它們確實代表了有利可圖的業務，並使 Trulicity 能夠幫助更多患有糖尿病的人。

So as we project into 2021, we expect continued strong Trulicity access and performance across all segments with modest unit price declines and continued faster growth in lower-priced segments to result in high single-digit total net price declines in 2021.

因此，當我們預測到 2021 年時，我們預計所有細分市場的 Trulicity 准入和業績將繼續保持強勁，單價適度下降，低價細分市場繼續較快增長，將導致 2021 年總淨價出現高個位數的下降。

However, I would note that this faster segment growth, which contributes to the net price decline, also shows up as higher overall prescription growth for GLP-1s as well.

但是，我會注意到，導致淨價格下降的這種更快的細分市場增長也顯示為 GLP-1 的整體處方增長更高。

Our outlook for total U.S. pricing trends remains unchanged, and we continue to expect mid-single-digit price declines for the full year in 2020 as well as moving into 2021.

我們對美國總定價趨勢的展望保持不變，我們繼續預計 2020 年全年以及進入 2021 年的價格將出現中個位數的下降。

This mid-single-digit price decline outlook includes, as we noted last quarter, a modest impact in 2020 from the effect of increased U.S. unemployment on segment mix as well as approximately $100 million to $200 million of impact in 2021.

正如我們上個季度所指出的那樣，這種中個位數的價格下跌前景包括美國失業率增加對細分市場組合的影響以及 2021 年約 1 億至 2 億美元的影響對 2020 年的適度影響。

Okay.

好的。

Moving to Europe.

搬到歐洲。

Revenue grew 9% in constant currency as volume grew by 10%, partially offset by price.

隨著銷量增長 10%，按固定匯率計算的收入增長了 9%，但被價格部分抵消。

Volume growth was positively impacted by Alimta in Germany due to our patent appeal victory and a court-ordered injunction against generics that had entered the market as well as Trulicity, Taltz, Olumiant and Verzenio.

由於我們的專利上訴勝利和法院下令禁止進入市場的仿製藥以及 Trulicity、Taltz、Olumiant 和 Verzenio，德國的 Alimta 對銷量增長產生了積極影響。

In Japan, revenue grew 1% in constant currency as 5% volume growth was partially offset by government-mandated price decreases that were effective March 2020.

在日本，按固定匯率計算，收入增長 1%，因為 5% 的銷量增長被政府規定的 2020 年 3 月生效的降價部分抵消。

Japan revenue benefited from a onetime sale of Cialis as well as good volume growth from Verzenio and Trulicity, partially offset by increased competition for Forteo.

日本收入受益於 Cialis 的一次性銷售以及 Verzenio 和 Trulicity 的良好銷量增長，部分被 Forteo 競爭加劇所抵消。

In China, revenue grew 10% in constant currency driven by 51% volume growth, partially offset by pricing concessions from the inclusion of TYVYT and Alimta in government-sponsored programs.

在中國，在銷量增長 51% 的推動下，按固定匯率計算的收入增長了 10%，但部分被 TYVYT 和 Alimta 納入政府資助項目的定價優惠所抵消。

These programs helped drive China's significant volume growth, which substantially increased access for patients to these important cancer medicines.

這些項目幫助推動了中國銷量的顯著增長，大大增加了患者獲得這些重要癌症藥物的機會。

We're excited about the momentum of our China oncology business and look forward to receiving regulatory action on Verzenio in the coming months.

我們對我們中國腫瘤業務的發展勢頭感到興奮，並期待在未來幾個月內收到對 Verzenio 的監管行動。

Outside of our oncology portfolio in China, recently launched products, Trulicity, Taltz, Jardiance and Olumiant, continue to have strong uptake.

除了我們在中國的腫瘤產品組合之外，最近推出的產品 Trulicity、Taltz、Jardiance 和 Olumiant 繼續獲得強勁的吸收。

Revenue in the rest of the world increased 3% in constant currency driven by increased volume from our key growth products.

由於我們主要增長產品的銷量增加，世界其他地區的收入按固定匯率計算增長了 3%。

Strong performance from Trulicity, Jardiance and Olumiant, was partially offset by decreased Humalog, Forteo, Cialis and Humulin volume.

Trulicity、Jardiance 和 Olumiant 的強勁表現被 Humalog、Forteo、Cialis 和 Humulin 銷量下降部分抵消。

As shown on Slide 11, our key growth products continue to drive impressive worldwide volume growth.

如幻燈片 11 所示，我們的主要增長產品繼續推動令人印象深刻的全球銷量增長。

These new medicines delivered nearly 13 percentage points of volume growth this quarter.

這些新藥在本季度實現了近 13 個百分點的銷量增長。

The strong volume trend in our key products was partially offset by a mix of competition and lower utilization of post-LOE product for Forteo as well as reduced Trajenta royalties from the restructuring of our alliance with Boehringer Ingelheim announced last year.

我們主要產品的強勁銷量趨勢被 Forteo 的競爭和 LOE 後產品利用率降低以及我們與勃林格殷格翰去年宣布的重組聯盟導致的 Trajenta 特許權使用費減少部分抵消。

We end the first 9 months of 2020 pleased that our key growth products have contributed approximately 15% year-to-date volume growth.

在 2020 年前 9 個月結束時，我們很高興我們的主要增長產品貢獻了約 15% 的年初至今銷量增長。

Slide 12 highlights the contributions of our key growth products.

幻燈片 12 突出了我們主要增長產品的貢獻。

In total, these brands generated nearly $3 billion in revenue this quarter, making up 52% of revenue.

這些品牌本季度總共創造了近 30 億美元的收入，佔收入的 52%。

Though our key products are well positioned to drive strong performance over the long term, we continue to see an impact from reduced patient starts due to COVID-19.

儘管我們的主要產品能夠很好地推動長期的強勁表現，但我們繼續看到由於 COVID-19 導致患者開始減少的影響。

In Q3, we were encouraged to see new patient starts recover off the troughs experienced in Q2 as the health system reopened around the world.

在第三季度，隨著全球衛生系統重新開放，我們很高興看到新患者開始從第二季度的低谷中恢復過來。

While different classes have recorded different rates, most classes remain 10% to 20% below pre-COVID baselines.

雖然不同的班級記錄了不同的比率，但大多數班級仍然比 COVID 之前的基線低 10% 到 20%。

On Slide 13, we provide an update on capital allocation.

在幻燈片 13 上，我們提供了資本配置的最新信息。

During the first 9 months of 2020, we invested nearly $6 billion to drive our future growth through a combination of business development, capital expenditures and after-tax investment in R&D, including the addition of lebrikizumab in a number of early stage agreements.

在 2020 年的前 9 個月，我們投資了近 60 億美元，通過結合業務發展、資本支出和研發的稅後投資來推動我們的未來增長，包括在一些早期協議中增加了 lebrikizumab。

In addition, we returned over $2.5 billion to shareholders via share repurchase and the dividend.

此外，我們通過股票回購和股息向股東返還了超過 25 億美元。

We remain well capitalized and have the ability to access debt markets at attractive rates.

我們仍然資本充足，有能力以有吸引力的利率進入債務市場。

We expect to continue to enhance our long-term growth by acquiring first or best-in-class pipeline assets, and we do not anticipate COVID impacts regarding travel or market uncertainty to affect our efforts.

我們希望通過收購一流或一流的管道資產來繼續增強我們的長期增長，我們預計 COVID 對旅行或市場不確定性的影響不會影響我們的努力。

Moving to Slide 14, you'll find our updated 2020 financial guidance, and this is based on our best estimates at this time.

轉到幻燈片 14，您會看到我們更新的 2020 年財務指導，這是基於我們目前的最佳估計。

Key assumptions supporting the guidance include health care activity will continue the positive trend seen in Q3, returning to historical levels as doctors utilize telehealth or in-person visits despite additional COVID-19 outbreaks.

支持該指南的主要假設包括醫療保健活動將繼續第三季度出現的積極趨勢，隨著醫生利用遠程醫療或親自就診，儘管發生了更多的 COVID-19 疫情，但醫療保健活動將恢復到歷史水平。

New patient prescriptions will continue to improve in the U.S. Pricing headwinds from increased utilization of patient affordability programs and changes in segment mix due to increased U.S. unemployment will continue to be modest.

美國的新患者處方將繼續改善。由於美國失業率增加導致患者負擔能力計劃的利用增加以及細分市場組合的變化，定價逆風將繼續溫和。

And promotional spend will constitute a mix of in-person customer interactions, direct-to-consumer advertising and investments in digital promotion.

促銷支出將包括面對面的客戶互動、直接面向消費者的廣告和對數字促銷的投資。

While uncertainty remains regarding resurgent waves of COVID-19 and any resulting impact on the pace of economic recovery around the world, we do believe health care activity will continue to be a priority and that most patients will find ways to access health care.

儘管 COVID-19 的捲土重來以及由此對全球經濟復甦步伐產生的任何影響仍存在不確定性，但我們確實相信醫療保健活動將繼續成為優先事項，並且大多數患者將找到獲得醫療保健的方法。

So based on these assumptions, we're maintaining our current full year revenue range.

因此，基於這些假設，我們將維持當前的全年收入範圍。

At the low end of the range, year-over-year sales growth in Q4 would be 8% to 9%, which, while a step-up from our third quarter growth rate, is supported by current volume trends and our expectations of more limited price impacts in the U.S. Achieving the higher end of the range likely requires some moderate sales from our COVID antibody, which we believe is possible but, of course, not certain at this point.

在該範圍的低端，第四季度的銷售額同比增長將在 8% 到 9% 之間，雖然比我們第三季度的增長率有所提高，但受到當前銷量趨勢和我們對更多增長的預期的支持對美國的價格影響有限。實現該範圍的高端可能需要我們的 COVID 抗體進行一些適度的銷售，我們認為這是可能的，但當然，目前還不確定。

Moving down the income statement.

向下移動損益表。

Our gross margin as a percent of revenue is unchanged on a GAAP and non-GAAP basis.

我們的毛利率佔收入的百分比在 GAAP 和非 GAAP 基礎上保持不變。

We are narrowing our range for marketing, selling and administrative expenses to $6.0 billion to $6.1 billion.

我們正在將營銷、銷售和管理費用的範圍縮小到 60 億至 61 億美元。

We are narrowing our range for research and development expenses to $5.8 billion to $5.9 billion, with investment in COVID-19 treatments of approximately $400 million for the full year likely to push us to the high end of our range as Lilly continues to self-fund these programs.

我們正在將研發費用範圍縮小到 58 億美元至 59 億美元，隨著禮來公司繼續自籌資金，全年對 COVID-19 治療的投資約為 4 億美元，這可能會將我們推向我們範圍的高端這些程序。

We believe these investments are critical to help combat the global pandemic.

我們認為，這些投資對於幫助抗擊全球流行病至關重要。

We are noting that our non-GAAP operating income as a percent of revenue goal of 31% excludes our substantial investments in COVID-19 treatments and any associated revenue with them.

我們注意到，我們的非 GAAP 營業收入佔收入目標的 31% 不包括我們對 COVID-19 治療的大量投資以及與之相關的任何收入。

Inclusive of these costs, we expect an operating margin of approximately 29%.

包括這些成本在內，我們預計營業利潤率約為 29%。

While these investments put near-term pressure on our operating margin, they continue to be the right decision for our company and for society.

儘管這些投資給我們的營業利潤率帶來了短期壓力，但它們仍然是我們公司和社會的正確決定。

And post launch, we do expect these therapies to be accretive to our operating income.

在推出後，我們確實希望這些療法能夠增加我們的營業收入。

We're updating the range of other income and expense to $450 million to $600 million of income, reflecting additional gains in our equity portfolio seen in the third quarter.

我們正在將其他收入和支出的範圍更新為 4.5 億美元至 6 億美元的收入，這反映了我們在第三季度看到的股票投資組合的額外收益。

As previously mentioned, this number is subject to volatility of the capital markets.

如前所述，這個數字受資本市場波動的影響。

Turning to taxes.

轉向稅收。

We're maintaining our GAAP and non-GAAP effective tax rate guidance at approximately 14%.

我們將 GAAP 和非 GAAP 有效稅率指導維持在約 14%。

Earnings per share are unchanged on a non-GAAP basis.

在非公認會計原則的基礎上，每股收益保持不變。

Our GAAP EPS is expected to be in the range of $6.20 to $6.40.

我們的公認會計原則每股收益預計在 6.20 美元至 6.40 美元之間。

As I noted with the revenue range, EPS totals in Q4 will be highly dependent on COVID sales, which is why we're maintaining a pretty broad $0.20 range as we head into the fourth quarter.

正如我在收入範圍中所指出的那樣，第四季度的每股收益總額將高度依賴於 COVID 銷售，這就是為什麼我們在進入第四季度時保持相當廣泛的 0.20 美元範圍。

We exit Q3 well positioned to continue delivering revenue growth and productivity despite the impact of the COVID-19 pandemic.

儘管受到 COVID-19 大流行的影響，我們退出第三季度仍處於有利地位，可以繼續實現收入增長和生產力。

We're proud of the investments we are making to help combat COVID-19 and are confident in the underlying strength of our business and our ability to overcome challenges.

我們為幫助對抗 COVID-19 所做的投資感到自豪，並對我們業務的潛在實力和克服挑戰的能力充滿信心。

Based on our current outlook for Q4, we believe we'll exit the year with strong underlying momentum for 2021.

根據我們目前對第四季度的展望，我們相信我們將在 2021 年以強勁的潛在勢頭結束這一年。

So I'll now turn the call over to Dan to provide an update on our ongoing efforts to develop treatments for COVID-19, a summary of key data disclosures in Q3 and an overall pipeline update.

因此，我現在將電話轉給 Dan，以提供我們正在開發 COVID-19 治療方法的最新情況、第三季度關鍵數據披露的摘要和整體管道更新。

Thanks, Josh.

謝謝，喬希。

Since our last call, we've made meaningful progress developing potential treatments for COVID-19, advancing key assets in our pipeline and presenting practice-changing clinical trial data at major medical meetings.

自上次電話會議以來，我們在開發 COVID-19 的潛在治療方法、推進我們管道中的關鍵資產並在主要醫學會議上展示改變實踐的臨床試驗數據方面取得了有意義的進展。

I'll begin with updates to our COVID-19 viral neutralizing antibody program, then I'll provide an update on the full pipeline, and I'll finish by highlighting key events since the last quarter.

我將從更新我們的 COVID-19 病毒中和抗體計劃開始，然後提供完整管道的更新，最後我將重點介紹自上個季度以來的關鍵事件。

Moving to Slide 15.

轉到幻燈片 15。

Lilly is testing single-antibody therapy as well as combinations of antibodies in several trials across 2 different patient populations: first, in the treatment of recently diagnosed ambulatory patients; and second, in the prophylactic or preventative setting amongst nursing home residents and staff.

禮來（Lilly）正在針對 2 個不同患者群體的多項試驗中測試單一抗體療法以及抗體組合：首先，用於治療最近診斷出的門診患者；其次，在療養院居民和工作人員的預防或預防環境中。

A third more severely ill population, i.e.

三分之一重病人口，即

hospitalized patients, has been studied in the ACTIV-3 trial only.

住院患者，僅在 ACTIV-3 試驗中進行了研究。

This clinical trial is being run by the NIH and is the only study evaluating the efficacy of bamlanivimab, also known as LY-CoV555, in hospitalized COVID-19 patients.

這項臨床試驗由 NIH 進行，是唯一一項評估 bamlanivimab（也稱為 LY-CoV555）對住院 COVID-19 患者療效的研究。

Based on an updated data set from the trial reviewed yesterday by the independent Data and Safety Monitoring Board, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab.

根據獨立數據和安全監測委員會昨天審查的試驗更新數據集，該住院環境中沒有其他 COVID-19 患者將接受 bamlanivimab。

The board's recommendation was based on trial data suggesting that the addition of bamlanivimab to remdesivir and other treatments used in the hospitalized setting is unlikely to further help hospitalized COVID-19 patients recover from this advanced stage of their disease.

委員會的建議基於試驗數據，表明將 bamlanimab 添加到 remdesivir 和住院環境中使用的其他治療不太可能進一步幫助住院的 COVID-19 患者從疾病的晚期階段恢復。

In this updated data set, differences in safety outcomes between the bamlanivimab and placebo groups were not significant.

在這個更新的數據集中，bamlanimab 組和安慰劑組之間的安全性結果差異不顯著。

Importantly, all other studies of bamlanivimab remain ongoing, including ACTIV-2, the NIH-sponsored study in recently diagnosed mild to moderate COVID-19 patients; BLAZE-1, Lilly's ongoing Phase II trial in people recently diagnosed with COVID-19 in the ambulatory setting, which is studying bamlanivimab as monotherapy and in combination with etesevimab, also known as LY-CoV016; and BLAZE-2, Lilly's Phase III study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities.

重要的是，所有其他關於 bamlanimab 的研究仍在進行中，包括 ACTIV-2，這是 NIH 贊助的針對最近診斷出的輕度至中度 COVID-19 患者的研究； BLAZE-1，禮來公司正在進行的 II 期臨床試驗，對像是最近在門診環境中診斷出患有 COVID-19 的人群，該試驗正在研究 bamlanivimab 作為單一療法並與 etesevimab 聯合使用，也稱為 LY-CoV016；和 BLAZE-2，禮來公司對 bamlanivimab 的 III 期研究，用於預防長期護理機構的居民和工作人員的 COVID-19。

While there was insufficient evidence from ACTIV-3 that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly's BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.

雖然來自 ACTIV-3 的證據不足以表明 bamlanivimab 在與 COVID-19 住院患者的其他治療相結合時改善了臨床結果，但基於禮來公司 BLAZE-1 研究的數據，我們仍然相信 bamlanivimab 單藥治療可能會阻止早期患者的疾病進展在 COVID-19 期間。

While the results in hospitalized patients were disappointing, we don't expect this to affect our chances of success in prophylaxis or in early treatment.

雖然住院患者的結果令人失望，但我們預計這不會影響我們在預防或早期治療中成功的機會。

And we thank the patients, physicians and staff participating in all clinical trials of our neutralizing antibodies, including ACTIV-3.

我們感謝參與我們的中和抗體（包括 ACTIV-3）所有臨床試驗的患者、醫生和工作人員。

Regarding the Lilly-sponsored COVID-19 neutralizing antibody program, we made key advances in the third quarter, which include: We initiated BLAZE-2, the Phase III trial studying post-exposure prophylaxis for residents and staff in nursing homes.

關於禮來 (Lilly) 贊助的 COVID-19中和抗體計劃，我們在第三季度取得了重大進展，其中包括：我們啟動了 BLAZE-2，這是研究療養院居民和工作人員暴露後預防的 III 期試驗。

We reported proof-of-concept data for bamlanivimab monotherapy in BLAZE-1, demonstrating a reduction in hospitalizations and ER visits in the outpatient setting.

我們報告了 BLAZE-1 中 bamlanivimab 單藥治療的概念驗證數據，表明門診患者住院和急診就診次數減少。

We reported that the combination therapy of bamlanivimab and etesevimab met the primary and secondary end points at an interim analysis of BLAZE-1, significantly reducing viral load and symptoms as well as meaningfully reducing hospitalizations and ER visits in the outpatient setting.

我們報告說，在 BLAZE-1 的中期分析中，bamlanivimab 和 etesevimab 的聯合治療達到了主要和次要終點，顯著降低了病毒載量和症狀，並顯著減少了門診住院和急診就診。

And we submitted a request for Emergency Use Authorization to the FDA for bamlanivimab monotherapy in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.

我們向 FDA 提交了一份緊急使用授權請求，用於對最近被診斷為輕度至中度 COVID-19 的高風險患者進行 bamlanimab 單藥治療。

We were particularly encouraged to show that neutralizing antibodies can help people clear virus more quickly, improve symptoms and, most importantly, prevent serious medical outcomes, like hospitalizations and ER visits.

我們特別受到鼓舞，證明中和抗體可以幫助人們更快地清除病毒，改善症狀，最重要的是，預防嚴重的醫療結果，如住院和急診室就診。

Notably, the pooled data of monotherapy and combination therapy showed a reduction of hospitalizations and ER visits of greater than 75% across all patients.

值得注意的是，單一療法和聯合療法的匯總數據顯示，所有患者的住院和急診就診減少了 75% 以上。

In addition, the monotherapy and combination therapy had an even larger effect size in high-risk patients, defined by body mass index or age.

此外，單一療法和聯合療法在高危患者中的效果更大，由體重指數或年齡定義。

We've now dosed approximately 1,000 trial participants with bamlanivimab alone or in combination with etesevimab.

我們現在已經給大約 1,000 名試驗參與者單獨服用 bamlanivimab 或與 etesevimab 聯合服用。

And we've shared safety and tolerability data for more than 400 patients in the monotherapy and combination therapy arms of BLAZE-1 on our call earlier this month, where we noted that monotherapy and combination therapy were both generally well tolerated with no significant safety concerns.

我們在本月早些時候的電話會議上分享了 BLAZE-1 單一療法和聯合療法組中 400 多名患者的安全性和耐受性數據，我們注意到單一療法和聯合療法通常都具有良好的耐受性，沒有明顯的安全問題.

No clinically meaningful differences in treatment-emergent adverse events were observed across the treatment groups, and the majority of treatment-emergent adverse events were mild to moderate in severity.

在治療組中未觀察到治療引起的不良事件具有臨床意義的差異，並且大多數治療引起的不良事件的嚴重程度為輕度至中度。

And there have been no drug-related serious adverse events reported thus far.

到目前為止，還沒有報告與藥物相關的嚴重不良事件。

We continue to accrue patients in BLAZE-1.

我們繼續在 BLAZE-1 中積累患者。

While the FDA is still reviewing our request for EUA for monotherapy, we will soon be ready to request Emergency Use Authorization for combination therapy.

雖然 FDA 仍在審查我們對 EUA 單藥治療的申請，但我們很快就會準備好申請聯合治療的緊急使用授權。

And we intend to submit that request to the FDA as early as November.

我們打算最早在 11 月將該請求提交給 FDA。

Another achievement this quarter as part of our efforts to develop potential treatments for COVID-19 was the positive outcome of baricitinib in NIH-sponsored ACTT-2 trial of hospitalized COVID-19 patients.

作為我們努力開發 COVID-19 潛在治療方法的一部分，本季度的另一項成就是 baricitinib 在 NIH 贊助的住院 COVID-19 患者 ACTT-2 試驗中取得了積極成果。

Baricitinib, in combination with remdesivir, significantly reduced time to recovery and improved clinical outcomes.

Baricitinib 與 remdesivir 聯合使用可顯著縮短康復時間並改善臨床結果。

A numerical decrease in mortality compared to remdesivir alone was also demonstrated.

與單獨使用瑞德西韋相比，死亡率在數字上有所下降。

These results were most pronounced in patients receiving oxygen.

這些結果在接受氧氣治療的患者中最為明顯。

Based on these data, we submitted a request for Emergency Use Authorization for baricitinib to the FDA.

基於這些數據，我們向 FDA 提交了巴瑞替尼緊急使用授權請求。

And global regulatory discussions are ongoing.

全球監管討論正在進行中。

With 2 submissions to the FDA this month for requests for Emergency Use Authorizations and with our neutralizing antibody combination therapy providing a potential for a third in November, I'm particularly proud of the progress we've made over such a short period of time to rapidly develop potential new solutions to aid physicians and patients in the battle against this pandemic.

本月向 FDA 提交了 2 份緊急使用授權請求，並且我們的中和抗體聯合療法在 11 月提供了三分之一的潛力，我為我們在如此短的時間內取得的進展感到特別自豪迅速開發潛在的新解決方案，以幫助醫生和患者抗擊這一流行病。

Moving to Slide 16.

轉到幻燈片 16。

You can see our select pipeline opportunities as of October 20.

截至 10 月 20 日，您可以查看我們精選的管道機會。

Movement since our last earnings call includes approval for Trulicity alternative dose, approval for baricitinib in moderate to severe atopic dermatitis, the previously mentioned initiation of the BLAZE-2 Phase III trial, the advancement of 2 immunology programs into Phase II, the initiation of 2 Phase I programs and the termination of a Phase I diabetes asset and termination of our Ang-2 antibodies Phase II proof-of-concept study in COVID-19 due to futility.

自上次財報電話會議以來的進展包括批准 Trulicity 替代劑量、批准巴瑞替尼治療中度至重度特應性皮炎、前面提到的 BLAZE-2 III 期試驗的啟動、2 個免疫學項目進入 II 期、2 個啟動I 期項目和 I 期糖尿病資產的終止以及我們在 COVID-19 中的 Ang-2 抗體 II 期概念驗證研究因無效而終止。

We also saw results from the Phase II trial of mevidalen, our D1-positive allosteric modulator in patients with Lewy body disease.

我們還看到了 mevidalen 的 II 期試驗結果，這是我們在路易體病患者中的 D1 陽性變構調節劑。

While we were disappointed that the study did not meet its primary cognitive endpoint at week 12, mevidalen did show encouraging motor and non-motor benefits.

雖然我們對該研究在第 12 週沒有達到其主要認知終點感到失望，但美維達倫確實顯示出令人鼓舞的運動和非運動益處。

And we are evaluating the next steps for this program at this time.

我們目前正在評估該計劃的後續步驟。

In addition, Pfizer and Lilly have been informed by the U.S. FDA that the agency intends to hold an advisory committee meeting, likely in the March 2021 time frame, to discuss the tanezumab application.

此外，美國 FDA 通知輝瑞和禮來公司，該機構打算在 2021 年 3 月的時間框架內召開諮詢委員會會議，討論 tanezumab 的應用。

As a result, the FDA's review will obviously extend beyond the current December 2020 PDUFA date.

因此，FDA 的審查顯然將超出當前 2020 年 12 月的 PDUFA 日期。

However, the FDA has not provided a new action date.

但是，FDA 沒有提供新的行動日期。

The agency communicated that its review of the application is ongoing and it has not requested any new clinical studies to be completed at this time.

該機構表示，其對該申請的審查正在進行中，目前尚未要求完成任何新的臨床研究。

Pfizer and Lilly will continue to work with the FDA as it completes its review of the application.

輝瑞和禮來將繼續與 FDA 合作，完成對申請的審查。

Moving to Slide 17.

轉到幻燈片 17。

We provide an update on our 2020 key events.

我們提供了 2020 年關鍵事件的最新信息。

The first 9 months of 2020 have been incredibly productive, as highlighted by a significant number of positive key milestones.

正如大量積極的關鍵里程碑所強調的那樣，2020 年的前 9 個月非常富有成效。

With only a few exceptions, we've delivered on the key events that we outlined back in December 2019.

除了少數例外，我們已經完成了我們在 2019 年 12 月概述的關鍵事件。

And we've added several more safeguards.

我們還添加了更多保護措施。

Most notably, since the last earnings call, we've had regulatory approvals for important new indications and line extensions for Trulicity, Taltz and Olumiant.

最值得注意的是，自上次財報電話會議以來，我們已經獲得了監管部門批准 Trulicity 、 Taltz 和 Olumiant 的重要新適應症和產品線擴展。

In collaboration with Boehringer Ingelheim, we also presented results from EMPEROR-Reduced trial in patients with heart failure with reduced ejection fraction or HFrEF.

我們還與勃林格殷格翰合作，展示了 EMPEROR-Reduced 對射血分數降低或 HFrEF 心力衰竭患者的試驗結果。

Jardiance demonstrated a 25% reduction in cardiovascular death or heart failure hospitalization.

Jardiance 證明心血管死亡或心力衰竭住院率降低了 25%。

In addition, Jardiance had a positive effect in key secondary endpoints, including first hospitalization for heart failure and an exploratory renal composite endpoint.

此外，Jardiance 對關鍵的次要終點有積極影響，包括首次因心力衰竭住院和探索性腎臟複合終點。

EMPEROR-Reduced included patients with and without diabetes.

EMPEROR-Reduced 包括患有和不患有糖尿病的患者。

And these data are encouraging to expand the use of Jardiance in patients with HFrEF.

這些數據鼓勵擴大 Jardiance 在 HFrEF 患者中的使用。

They also add to the existing body of evidence showing that cardiovascular and renal benefits of Jardiance, as first demonstrated in the EMPA-REG OUTCOME trial.

他們還增加了現有的證據表明 Jardiance 對心血管和腎臟有益，正如 EMPA-REG OUTCOME 試驗中首次證明的那樣。

We're on track to submit these data to regulators later this year and look forward to the EMPEROR-Preserved trial in HFpEF in 2021.

我們有望在今年晚些時候向監管機構提交這些數據，並期待 2021 年在 HFpEF 中進行 EMPEROR-Preserved 試驗。

We also presented important data for Verzenio in early breast cancer at the virtual ESMO meeting this quarter confirming that Verzenio is the only CDK4/6 inhibitor to demonstrate a benefit in this population and the first advancement for these patients in almost 2 decades.

我們還在本季度的虛擬 ESMO 會議上展示了 Verzenio 在早期乳腺癌中的重要數據，證實 Verzenio 是唯一一種在該人群中顯示出益處的 CDK4/6 抑製劑，並且是近 20 年來對這些患者的首次進展。

Verzenio showed a 25% reduction in risk of cancer recurrence at a 2-year landmark analysis.

Verzenio 在一項為期 2 年的里程碑式分析中顯示癌症復發的風險降低了 25%。

Verzenio also reduced the risk of distant metastasis by 28%, an essential objective for any novel therapy in HR-positive, HER2-negative early breast cancer, as distant recurrence is currently an incurable event.

Verzenio 還將遠處轉移的風險降低了 28%，這是 HR 陽性、HER2 陰性早期乳腺癌的任何新療法的基本目標，因為遠處復發目前是無法治癒的事件。

This is an important observation that bodes well for overall survival since according to published literature, improvements in distant relapse-free survival have been shown to be a leading indicator for improved overall survival.

這是一個重要的觀察結果，預示著總體生存率良好，因為根據已發表的文獻，遠處無復發生存率的提高已被證明是總體生存率提高的領先指標。

The monarchE study is ongoing.

monarchE 研究正在進行中。

Study participants will remain on trial and continue to be followed, and additional results will be presented in the future.

研究參與者將繼續接受試驗並繼續跟踪，未來將提供更多結果。

As we stated previously, we intend to submit for regulatory review by the end of the year.

正如我們之前所說，我們打算在年底前提交監管審查。

We anticipate a standard review time line with the FDA.

我們預計與 FDA 的標準審查時間表。

While there have been many positive pipeline events already this year, we still have 2 important readouts to come yet this year and a number of updates that will occur during the first half of 2021.

儘管今年已經有許多積極的管道事件，但我們今年仍有 2 個重要的數據要發布，並且將在 2021 年上半年進行一些更新。

Before year-end, we'll present additional data from the Phase I/II BRUIN study for LOXO-305, our BTK inhibitor.

在年底之前，我們將展示我們的 BTK 抑製劑 LOXO-305 的 I/II 期 BRUIN 研究的更多數據。

We'll also have top line results from SURPASS-1, the first Phase III trial to read out from the tirzepatide type 2 diabetes program.

我們還將獲得 SURPASS-1 的頂級結果，這是從 tirzepatide 2 型糖尿病項目中讀出的第一個 III 期試驗。

SURPASS-1 is a placebo-controlled monotherapy trial.

SURPASS-1 是一項安慰劑對照的單一療法試驗。

We look forward to sharing these data in the coming months for this important program that we believe will raise the bar for treatment expectations for patients with type 2 diabetes.

我們期待在未來幾個月內為這個重要項目分享這些數據，我們相信這將提高對 2 型糖尿病患者的治療預期標準。

We have a lot of momentum in R&D at Lilly, which will carry into 2021, where we have a number of additional data readouts, including the remainder of the registrational Phase III tirzepatide type 2 diabetes trials; Phase III data for mirikizumab in ulcerative colitis; Phase III data for lebrikizumab in atopic dermatitis; Phase III Jardiance HFpEF data; Phase II data from 2 Alzheimer's trials, including an important readout from our plaque-clearing antibody, donanemab, expected early in Q1 2021.

我們在禮來（Lilly）的研發方面有很大的動力，這將持續到 2021 年，我們有許多額外的數據讀出，包括註冊 III 期 tirzepatide 2 型糖尿病試驗的其餘部分； mirikizumab 治療潰瘍性結腸炎的 III 期數據； lebrikizumab 治療特應性皮炎的 III 期數據； III 期 Jardiance HFpEF 數據；來自 2 項阿爾茨海默氏症試驗的 II 期數據，包括我們的斑塊清除抗體 donanemab 的重要讀數，預計將於 2021 年第一季度初公佈。

We remain excited about the potential of this molecule to make a real difference for patients with Alzheimer's disease.

我們仍然對這種分子對阿爾茨海默病患者產生真正影響的潛力感到興奮。

Finally, we look forward to multiple potential proof-of-concept studies from our early stage portfolios in immunology, neuroscience, diabetes and oncology.

最後，我們期待從我們在免疫學、神經科學、糖尿病和腫瘤學的早期投資組合中進行多項潛在的概念驗證研究。

We've risen to the challenge this year as we engaged in the fight against COVID-19.

在與 COVID-19 的鬥爭中，我們迎接了今年的挑戰。

We showed our adaptability and commitment to developing medicines through innovative ways.

我們展示了我們通過創新方式開發藥物的適應性和承諾。

I'm inspired by the indefatigable effort by our teams in their pursuit of new medicines for patients.

我們的團隊在為患者尋求新藥方面所付出的不懈努力讓我深受鼓舞。

Dave, back to you for some closing remarks.

戴夫，回來給你一些閉幕詞。

Thanks, Dan.

謝謝，丹。

2020 has been a difficult yet remarkable year.

2020年是艱難但不平凡的一年。

Despite challenges and the resulting choppiness of our quarterly results, we've delivered volume-driven growth of 6% through the first 3 quarters of this year.

儘管面臨挑戰並導致我們的季度業績波動，但我們在今年前三個季度實現了 6% 的銷量增長。

Excluding investments in COVID-19 therapies, we've expanded our operating margin by 160 basis points compared to the first 3 quarters of 2019.

不包括對 COVID-19 療法的投資，與 2019 年前三個季度相比，我們的營業利潤率提高了 160 個基點。

We've made meaningful progress this year on our innovation-based strategy, launching 3 new medicines and a number of NILEX, delivering important data readouts for key pipeline molecules and developing and submitting EUAs for potential treatment for a virus unknown to the world at this time last year.

今年我們在基於創新的戰略上取得了有意義的進展，推出了 3 種新藥和一些 NILEX，提供了關鍵管道分子的重要數據讀數，並開發和提交了 EUA，用於治療世界未知病毒的潛在治療方法去年的時候。

And over the next few months, we have several highly anticipated pipeline readouts on deck.

在接下來的幾個月裡，我們有幾個備受期待的管道讀數。

We continue to look for opportunities to augment the future growth of our company through business development and then return excess capital to shareholders.

我們繼續尋找機會，通過業務發展增加公司未來的增長，然後將多餘的資本返還給股東。

While the COVID-19 pandemic will continue to challenge us, the growth products in our commercial portfolio, limited patent expiry in the next 5 years and margin expansion opportunities before us as well as upcoming data readouts in the pipeline, I like our prospects.

儘管 COVID-19 大流行將繼續挑戰我們，但我們商業組合中的增長產品、未來 5 年有限的專利到期、我們面前的利潤率擴張機會以及即將發布的數據讀數，我喜歡我們的前景。

And I thank my Lilly teammates for persevering and performing amidst a year of challenges to continue to deliver meaningful innovation for the patients we serve.

我感謝我的禮來（Lilly）隊友在一年的挑戰中堅持和表現，繼續為我們服務的患者提供有意義的創新。

This concludes our prepared remarks.

我們準備好的評論到此結束。

And now I'll turn the call over to Kevin to moderate the Q&A.

現在我將把電話轉給 Kevin 來主持問答環節。

Thanks, Dave.

謝謝，戴夫。

(Operator Instructions)

（操作員說明）

Lois, please provide the instructions for the Q&A session and then we're ready for the first caller.

Lois，請提供問答環節的說明，然後我們就可以接聽第一個來電者了。

(Operator Instructions) And our first question is from Louise Chen from Cantor.

（操作員說明）我們的第一個問題來自 Cantor 的 Louise Chen。

So my first question for you is why didn't you lower or tighten your 2020 guidance and leave the antibody sales as upside?

所以我問你的第一個問題是，你為什麼不降低或收緊 2020 年的指導，讓抗體銷售保持上行空間？

Are you having a high degree of conviction behind this Emergency Use Authorization?

您對這項緊急使用授權有高度的信念嗎？

Or are you seeing some positive trends shape up for the fourth quarter?

或者您是否看到第四季度出現了一些積極的趨勢？

And then my follow-up question is what are your thoughts on the upcoming FDA AdCom meeting to review BIIBs, aducanumab?

然後我的後續問題是，您對即將召開的 FDA AdCom 會議審查 BIIB、aducanumab 有何看法？

Do you think this will close the door on Alzheimer's drug development or herald a new beginning?

你認為這會關閉阿爾茨海默病藥物開發的大門還是預示著一個新的開始？

Thanks, Louise.

謝謝，路易絲。

We'll go to Josh for the first question on guidance and then Dan to the question on the FDA Adcom.

我們將向 Josh 詢問有關指導的第一個問題，然後向 Dan 詢問有關 FDA Adcom 的問題。

Yes.

是的。

Thanks, Louise.

謝謝，路易絲。

Yes, I think as we look at sales guidance and the implied Q4 absolute numbers, we see the trends now.

是的，我認為當我們查看銷售指導和隱含的第四季度絕對數字時，我們現在看到了趨勢。

We're at the end of October.

我們在十月底。

I think we feel good about the lower end of the range, for sure, based on just commercial performance of our products around the world.

我認為我們對這個範圍的低端感覺很好，當然，僅基於我們產品在全球的商業表現。

We have submitted an EUA.

我們已提交 EUA。

Dan talked about the data behind that.

丹談到了這背後的數據。

So I think it's reasonable to include a potential upside associated with some sales of that antibody to governments around the world in Q4.

因此，我認為在第四季度將與該抗體出售給世界各國政府相關的潛在優勢包括在內是合理的。

Of course, it is uncertain.

當然，這是不確定的。

That is why we've kept the range.

這就是我們保持範圍的原因。

Thanks, Josh.

謝謝，喬希。

Dan?

擔？

Yes.

是的。

Thanks, Louise, for the question on the adu AdCom.

謝謝，路易絲，關於 adu AdCom 的問題。

Of course, like everyone else, we'll be watching it with a great interest, but I don't think I can handicap it one way or the other.

當然，和其他人一樣，我們會懷著極大的興趣觀看它，但我認為我不能以某種方式阻礙它。

The way I see it, the important observation here is around the evidence lowering plaques can lead to cognitive benefits in Alzheimer's disease.

在我看來，這裡的重要觀察是圍繞降低斑塊可以導致阿爾茨海默病認知益處的證據。

I think we've seen it across a couple of data presentations now.

我想我們現在已經在幾個數據演示中看到了它。

And that's what gives us confidence in our own donanemab, our N3pG antibody that's currently in Phase II.

這就是讓我們對我們自己的 donanemab 充滿信心的原因，我們的 N3pG 抗體目前處於 II 期。

Just as a reminder, this is a pretty large Phase II.

提醒一下，這是一個相當大的第二階段。

We've designed it with special care, enrolling a very homogenous group of patients so that it could be powered to show us an efficacy signal, if present.

我們特別小心地設計了它，招募了一組非常同質的患者，這樣它就可以向我們展示功效信號（如果存在）。

And we look forward to seeing that data early next year.

我們期待在明年初看到這些數據。

Thanks, Dan.

謝謝，丹。

Louise, thanks for your questions.

路易絲，謝謝你的提問。

The next caller is Tim Anderson from Wolfe Research.

下一位來電者是來自 Wolfe Research 的 Tim Anderson。

I have a question on tirzepatide.

我有一個關於替西帕肽的問題。

Important event coming up, your first readout of Phase III.

即將到來的重要事件，您對第三階段的第一次讀數。

Can you characterize your level of confidence that the Phase III results will wow investors kind of like the Phase II results did?

您能否描述您對第三階段結果會像第二階段結果一樣讓投資者讚歎的信心水平？

It's notable that analysts already carry a $5 billion number for this, which is a high number.

值得注意的是，分析師已經為此提出了 50 億美元的數字，這是一個很高的數字。

And I'm wondering if you can talk about both efficacy and tolerability and safety relative to Phase II in terms of what you expect.

我想知道您是否可以根據您的期望談論相對於 II 期的療效、耐受性和安全性。

I know that's asking you to predict how these readouts go, but it's what we have to do as investors.

我知道這要求你預測這些讀數的走勢，但這是我們作為投資者必須做的事情。

So it'd be great to get your best guess on that.

所以最好能得到你最好的猜測。

And related to that question, how much data can we realistically expect that you'll provide in the top line press release?

與這個問題相關的是，我們實際上可以期望您在頂線新聞稿中提供多少數據？

Thanks, Tim.

謝謝，蒂姆。

We'll go to Mike Mason for those questions.

這些問題我們會去找邁克梅森。

Yes.

是的。

Thanks for the question.

謝謝你的問題。

We appreciate it.

我們很感激。

We've never been more excited about our tirzepatide program.

我們從未對我們的 tirzepatide 計劃感到如此興奮。

In our Phase II type 2 diabetes studies, 43% of people on tirzepatide had reached a final A1c of 5.7%, which is normal A1c, versus only 2% for the market leader, Trulicity.

在我們的 II 期 2 型糖尿病研究中，43% 的 tirzepatide 患者最終 A1c 達到 5.7%，這是正常的 A1c，而市場領導者 Trulicity 僅為 2%。

34% of people on tirzepatide lost more than 15% of their body weight versus 2% for Trulicity.

服用 tirzepatide 的人中有 34% 的人體重減輕了 15% 以上，而 Trulicity 為 2%。

And tirzepatide will be delivered in the same patient-friendly device as Trulicity.

tirzepatide 將在與 Trulicity 相同的患者友好型設備中交付。

Tirzepatide has the opportunity to become a foundational treatment for someone living with type 2 diabetes that not only need A1c control but could benefit from significant weight loss, which brings additional metabolic health benefits.

Tirzepatide 有機會成為 2 型糖尿病患者的基礎治療，他們不僅需要控制 A1c，而且可以從顯著的體重減輕中受益，從而帶來額外的代謝健康益處。

Further, we're very excited about what tirzepatide can do in obesity and NASH.

此外，我們對 tirzepatide 在肥胖和 NASH 中的作用感到非常興奮。

As you take a look at the results from SURPASS-1 later this year, we'll get the results.

當您查看今年晚些時候 SURPASS-1 的結果時，我們將得到結果。

We'll issue a press release.

我們將發布新聞稿。

That will likely be top line results.

這可能是最重要的結果。

We won't have full data, be able to do a full analysis.

我們不會有完整的數據，可以做一個完整的分析。

That will come later at medical meetings in 2021.

這將在 2021 年晚些時候的醫學會議上公佈。

Thanks, Mike.

謝謝，邁克。

Tim, thanks for your questions.

蒂姆，謝謝你的提問。

And that will come from Umer Raffat from Evercore ISI.

這將來自 Evercore ISI 的 Umer Raffat。

I have one for Dan and one for Dave, if I may.

如果可以的話，我有一份給丹，一份給戴夫。

Perhaps, maybe starting with you, Dave.

也許，也許從你開始，戴夫。

On the Alzheimer's A4 trial, you've previously expressed openness to possibly taking an interim analysis.

在阿爾茨海默氏症 A4 試驗中，您之前曾表示願意進行中期分析。

I know you have 2 years plus of follow-up by now already, maybe 3 years of follow-up by next year.

我知道你現在已經有 2 年以上的隨訪，明年可能會有 3 年的隨訪。

Is that something you're still open to?

那是你仍然開放的東西嗎？

Just wanted to hear your thoughts.

只是想听聽你的想法。

And then, Dan, there's a little bit of confusion on tirzepatide, perhaps in part because both the clin trials as well as the Lilly slide suggest the trial had a primary completion in October.

然後，丹，對 tirzepatide 有一點困惑，部分原因可能是臨床試驗和禮來公司的幻燈片都表明該試驗在 10 月份初步完成。

But when I map out when the last patient entered, which was first week of February, and add in the 40 weeks, which is a primary endpoint, it doesn't look like the trials met the primary endpoint yet in all the patients.

但是，當我計算出最後一位患者進入的時間，也就是 2 月的第一周，並加上作為主要終點的 40 週時，看起來試驗在所有患者中都沒有達到主要終點。

And it will probably be in November and then some time to announce this.

它可能會在 11 月，然後是一段時間來宣布這一點。

So can you confirm if I'm off track there?

那麼你能確認我是否偏離了軌道嗎？

Thanks, Umer.

謝謝，烏默爾。

Dave?

戴夫？

Well, I think you directed the A4 question to me.

好吧，我想你把 A4 問題指向了我。

Yes.

是的。

But probably Dan is able to answer that better.

但也許丹能夠更好地回答這個問題。

Dan, why don't you take the A4 question?

丹，你為什麼不做 A4 題？

Yes.

是的。

No.

不。

No, thanks for both of those questions.

不，謝謝這兩個問題。

Of course, A4 is an ongoing trial in patients who are presymptomatic.

當然，A4 是一項針對症狀前患者的持續試驗。

They don't even have the symptoms of Alzheimer's disease, but they have amyloid plaques as detected by imaging.

他們甚至沒有阿爾茨海默病的症狀，但通過成像檢測到他們有澱粉樣斑塊。

And we're testing if solanezumab and now a higher dose of solanezumab can have a benefit in those patients.

我們正在測試 solanezumab 和現在更高劑量的 solanezumab 是否可以對這些患者有益。

We haven't commented on whether or not there could be opportunities for an interim look here.

我們沒有評論這裡是否有機會進行臨時觀察。

And right now we're just focused on the final analysis in that trial.

現在我們只專注於該試驗的最終分析。

With respect to the timing of the tirzepatide trial and the details on clinicaltrials.gov, I can just reconfirm what we said earlier on the call, which is that we expect to have that data and top line it in coming months.

關於 tirzepatide 試驗的時間安排和臨床試驗.gov 上的詳細信息，我可以再次確認我們早些時候在電話會議上所說的話，即我們希望在未來幾個月內獲得這些數據並對其進行頂線。

It's obviously a major event for us.

這對我們來說顯然是一件大事。

And you can assume that when we get that data, we're going to turn it around quite quickly.

你可以假設當我們得到這些數據時，我們會很快扭轉局面。

Thanks, Dan.

謝謝，丹。

Umer, thanks for your questions.

烏默爾，謝謝你的提問。

The next question is from the line of Greg Gilbert from Truist.

下一個問題來自 Truist 的 Greg Gilbert。

I'm going to start with another one on Alzheimer's.

我要從另一篇關於阿爾茨海默氏症的文章開始。

Dan, I'm not sure to what degree you can comment on this, but I'm curious how interrelated your studies are and the agency's view of aducanumab.

丹，我不確定你能在多大程度上對此發表評論，但我很好奇你的研究與該機構對 aducanumab 的看法之間有多麼相互關聯。

Maybe asked another way, do you think the agency can act on their application without seeing your data, which is coming pretty soon?

也許換一種方式問，您認為該機構可以在不查看您的數據的情況下對他們的申請採取行動，這很快就會到來？

It seems to me that what you're bringing to the table is pretty important in the field.

在我看來，你帶來的東西在現場非常重要。

And then secondly, I know it's a little early.

其次，我知道現在有點早。

I was hoping you could talk to your growing confidence in the IL-2 approach since you signed that collaboration a few years ago.

自從幾年前簽署合作協議以來，我希望您能談談您對 IL-2 方法日益增長的信心。

It looks like there's some additional data coming at ACR as well.

看起來 ACR 也有一些額外的數據。

Thanks, Greg.

謝謝，格雷格。

We'll go to Dan for both those questions.

對於這兩個問題，我們都會去找丹。

Yes.

是的。

Thanks, Greg.

謝謝，格雷格。

Two good, interesting questions.

兩個很好，有趣的問題。

I think on Alzheimer's disease, your question is how will the FDA think about sort of a class effect here, if multiple plaque long antibodies show the same result or if they show different results.

我認為關於阿爾茨海默病，你的問題是，如果多個斑塊長抗體顯示相同的結果或顯示不同的結果，FDA 將如何考慮這裡的一類效應。

I don't know.

我不知道。

I mean I can't speculate on agency actions.

我的意思是我不能推測機構的行動。

But I can say that it wouldn't surprise me if regulators around the world did take sort of the totality of evidence approach in Alzheimer's disease, which could be across multiple molecules in different trials, to give confidence about a particular mechanism, in this case, of course, plaque lowering.

但我可以說，如果世界各地的監管機構確實對阿爾茨海默病採取了某種全面的證據方法，這可能跨越不同試驗中的多個分子，以對特定機制給予信心，在這種情況下，我不會感到驚訝。 ，當然，牙菌斑降低。

Having said that, though, each molecule will still have to pass a certain bar of evidence for benefit versus risk in the intended use population.

儘管如此，每個分子仍然必須通過一定的證據來確定預期使用人群中的收益與風險。

I do think, though, that if adu is deemed to have a positive effect and our drug ultimately has a positive effect, the convergence of those 2 events could bode well for both drugs.

不過，我確實認為，如果 adu 被認為具有積極作用並且我們的藥物最終具有積極作用，那麼這兩個事件的融合對這兩種藥物來說都是好兆頭。

But there's a lot that has to happen before we get there, Greg.

但在我們到達那里之前，還有很多事情要做，格雷格。

With respect to IL-2, yes, as this molecule progresses in clinical trials, we're growing more confident in the hypothesis that underlies this effort.

關於 IL-2，是的，隨著這種分子在臨床試驗中的進展，我們對作為這項努力的基礎的假設越來越有信心。

This is a low-dose PEGylated IL-2 that's meant to stimulate T regulatory cells without stimulating effector T cells.

這是一種低劑量聚乙二醇化 IL-2，旨在刺激 T 調節細胞而不刺激效應 T 細胞。

And we've now presented data from Phase I that showed we had exactly that effect.

我們現在已經展示了第一階段的數據，表明我們確實有這種效果。

In a dose-dependent way, we can boost Tregs.

以劑量依賴的方式，我們可以增強 Tregs。

And we hope that, that will have a modulatory effect on autoimmune disease.

我們希望，這將對自身免疫性疾病產生調節作用。

Based on our confidence in the biomarker here and the mechanism of action, we've committed to starting a number of Phase II trials here in parallel to understand how these changes in regulatory T cells translates -- could translate to clinical benefits for patients in diseases like lupus or IBD or dermatologic disease.

基於我們對這裡的生物標誌物和作用機制的信心，我們承諾在這裡同時開始一些 II 期試驗，以了解調節性 T 細胞的這些變化如何轉化——可以轉化為疾病患者的臨床益處如狼瘡或IBD或皮膚病。

And so those trials are starting, and we look forward to getting data from them.

所以這些試驗開始了，我們期待著從他們那裡獲得數據。

Thanks, Dan.

謝謝，丹。

Greg, thanks for your questions.

格雷格，謝謝你的問題。

The next question is from Chris Schott from JPMorgan.

下一個問題來自摩根大通的 Chris Schott。

Just my question is on Trulicity.

只是我的問題是關於 Trulicity。

It seems like there's 2 issues kind of impacting the quarter: the first was the timing of the doughnut hole impact; and the second was this channel mix issue, if I was hearing you correctly.

似乎有兩個問題會影響本季度：第一個是甜甜圈洞影響的時間；第二個是頻道混合問題，如果我沒聽錯的話。

So I guess on channel mix, is the net of the unfavorable price, I guess balanced against the higher volumes, a net neutral versus your original expectations?

所以我猜在渠道組合上，是不利價格的淨值，我想與更高的交易量相平衡，與您最初的預期相比，淨中性？

Or is volume only partially offsetting this kind of mix issue that you're dealing with, I guess, on that product specifically?

或者，我猜，銷量只是部分抵消了你正在處理的這種混合問題，具體是在那個產品上？

And then my second question was on margin evolution going forward.

然後我的第二個問題是關於未來的利潤演變。

Should we be thinking about the 31% operating margin ex the COVID investments as your baseline to grow off of as we think about 2021 and beyond?

在我們考慮 2021 年及以後的時間時，我們是否應該考慮將 31% 的營業利潤率（不包括 COVID 投資）作為您的增長基準？

Or should we still think about some kind of lingering COVID investments that could impact margins as we move through next year?

或者我們是否還應該考慮一些揮之不去的 COVID 投資，這些投資可能會在明年影響利潤率？

Thanks, Chris.

謝謝，克里斯。

We'll go to Mike Mason for the question on Trulicity then Josh for the question on margin evolution.

我們將向 Mike Mason 詢問有關 Trulicity 的問題，然後向 Josh 詢問有關邊際演變的問題。

Yes.

是的。

Thanks for your question.

謝謝你的問題。

Overall, we're very confident about the growth potential of the GLP class and Trulicity.

總的來說，我們對 GLP 類和 Trulicity 的增長潛力非常有信心。

The GLP class is performing strong with TRx growth of 23% for the quarter during the COVID pandemic.

GLP 類別表現強勁，在 COVID 大流行期間本季度的 TRx 增長了 23%。

Trulicity continues to hold market share leadership in the face of semaglutide with a 45% share of market.

面對擁有 45% 市場份額的 semaglutide，Trulicity 繼續保持市場份額領先地位。

Overall, Trulicity grew volume 26% in the U.S. at a time when patient office visits for type 2 diabetes remains 20% lower than last year due to the COVID pandemic.

總體而言，由於 COVID 大流行，在 2 型糖尿病患者就診次數仍比去年低 20% 的情況下，Trulicity 在美國的銷量增長了 26%。

When you take a look at segment mix, what we're seeing is that Trulicity performed well in commercial and Part D, holding market share leadership and growing gross sales year-to-date at 29% in commercial and 44% in Part D. Trulicity's segment mix was really driven by stronger-than-expected performance, both share and volume, in growing lower-priced segments like Medicaid.

當您查看細分市場組合時，我們看到的是，Trulicity 在商業和 D 部分錶現良好，保持市場份額領先地位，今年迄今為止，商業銷售額增長 29%，D 部分增長 44%。 Trulicity 的細分市場組合實際上是由在 Medicaid 等增長中的低價細分市場中的份額和數量均強於預期的表現推動的。

Even at the lower prices, Medicaid growth brings in profitable business for Lilly and helps people living with diabetes.

即使價格較低，醫療補助的增長也為禮來帶來了有利可圖的業務，並幫助了糖尿病患者。

I'll highlight one decision that we made.

我將重點介紹我們做出的一項決定。

During the early stages of the COVID pandemic, we were concerned about people on commercial insurance losing their jobs moving to Medicaid and having to stop take Trulicity because we had lower access in Medicaid.

在 COVID 大流行的早期階段，我們擔心商業保險的人們會失去工作，轉而轉向 Medicaid，並且不得不停止服用 Trulicity，因為我們在 Medicaid 中的准入門檻較低。

We didn't think this dynamic would be best for people living with diabetes during the pandemic.

我們認為這種動態對於大流行期間的糖尿病患者來說並不是最好的。

Thus, we prioritize improving our access in Medicaid to help people living with diabetes.

因此，我們優先考慮改善我們在 Medicaid 中的可及性，以幫助糖尿病患者。

For example, we were upgraded on California Medicaid early in Q2.

例如，我們在第二季度初就升級了加州醫療補助計劃。

And we've seen Trulicity volume in California Medicaid nearly double this year, which is really great for everyone.

我們已經看到今年加州醫療補助計劃中的 Trulicity 數量幾乎翻了一番，這對每個人來說都非常棒。

I remain very excited and confident in Trulicity.

我仍然對 Trulicity 感到非常興奮和自信。

Thanks, Mike.

謝謝，邁克。

Josh?

喬什？

Yes.

是的。

Thanks, Chris.

謝謝，克里斯。

On margin -- so yes, so we've tried to separate out the COVID investments this year, which we've mentioned will -- the expense will be in the range of $400 million for the year.

在保證金上——是的，所以我們試圖將今年的 COVID 投資分開，我們已經提到過——今年的費用將在 4 億美元的範圍內。

As you know, we've been focused on 31% operating margin as a goal for 2020.

如您所知，我們一直將 31% 的營業利潤率作為 2020 年的目標。

And given the guidance that we presented, not including anything from COVID, we're confident we'll achieve that 31%.

鑑於我們提供的指導，不包括來自 COVID 的任何內容，我們有信心實現 31%。

I think that's the right baseline to think about going forward on an overall basis.

我認為這是考慮整體前進的正確基準。

Now we will have COVID investments that move into 2021 as we continue the trials that we've already put up and running.

現在，隨著我們繼續進行我們已經進行並運行的試驗，我們將在 2021 年進行 COVID 投資。

Again, though, we are expecting, given the submission of the EUA and the data that we have, that there will be, at some point, sales associated with those investments.

不過，鑑於 EUA 的提交和我們擁有的數據，我們再次預計，在某個時候，與這些投資相關的銷售將會出現。

I think if we look at just isolating the expense and the sales, we'll have to come back on that.

我認為，如果我們只考慮將費用和銷售額分開，我們將不得不重新考慮這一點。

We haven't -- we don't have prices or volumes or anything around the world.

我們沒有——我們沒有世界各地的價格或數量或任何東西。

So I think the COVID piece in 2021, we will have some expense.

所以我認為 2021 年的 COVID 部分，我們會有一些費用。

But realistically, I think the way to think about our business is 31% operating margin, excluding the extraordinary COVID impact and margin expansion then in 2021 and really through 2025, as we've talked about.

但實際上，我認為考慮我們業務的方式是 31% 的營業利潤率，不包括 2021 年和 2025 年的非凡 COVID 影響和利潤率擴張，正如我們已經談到的那樣。

So I think COVID should help us, I think, from an overall economic perspective in that period if the product is -- product or products are successful.

所以我認為，如果產品是成功的，我認為從那個時期的整體經濟角度來看，COVID 應該對我們有所幫助。

But really, I think the focus on long-term margin expansion sort of cuts through anything that we see in the near term on COVID.

但實際上，我認為對長期利潤率擴張的關注會削弱我們在短期內看到的關於 COVID 的任何事情。

And we're committed to those margin expansion plans that we've talked about pre-pandemic.

我們致力於實施我們在大流行前討論過的那些利潤率擴張計劃。

Thanks, Josh.

謝謝，喬希。

Chris, thanks for your questions.

克里斯，謝謝你的提問。

The next caller is from Steve Scala from Cowen.

下一位來電者來自 Cowen 的 Steve Scala。

A couple of questions.

幾個問題。

First, Dan, in the past, when you have referred to very low dropout rates in SURPASS-1, were you referring to analysis on an intent-to-treat basis?

首先，Dan，過去，當您在 SURPASS-1 中提到非常低的輟學率時，您是指基於意向治療的分析嗎？

I fear Lilly is preparing us for solid data on an efficacy estimand basis but less compelling on an intent-to-treat basis.

我擔心禮來（Lilly）會在療效估計的基礎上為我們準備可靠的數據，但在意向治療的基礎上卻沒有那麼令人信服。

And then the second question is it was said earlier in the call that Lilly has never been more excited about tirzepatide.

然後第二個問題是，在電話會議的早些時候，禮來公司對 tirzepatide 從未如此興奮過。

I thought that was an interesting choice of words given the importance of the event and the lack of clarity on the status of the trial at this point.

考慮到事件的重要性以及目前對審判狀態的不明確，我認為這是一個有趣的詞語選擇。

It implies that you're more excited than you were in Q2 or Q1 or any time in between.

這意味著您比第二季度或第一季度或兩者之間的任何時候都更興奮。

So can you tell us if any member of management has any knowledge whatsoever of the results of SURPASS-1?

那麼，您能否告訴我們是否有任何管理層成員對 SURPASS-1 的結果有任何了解？

Thanks, Steve.

謝謝，史蒂夫。

We'll go to Dan for the question on dropout rates and then Mike can talk about his -- the question on tirzepatide.

我們會去找丹關於輟學率的問題，然後邁克可以談談他的——關於替西帕肽的問題。

Sure.

當然。

Thanks, Steve.

謝謝，史蒂夫。

What we said with respect to people dropping out of our clinical trials was that we hadn't seen an effect from COVID-19.

對於退出臨床試驗的人，我們所說的是，我們沒有看到 COVID-19 的影響。

We were quite worried about that in the early days of the pandemic when the tirzepatide trials had become fully enrolled and were some of the most important and largest trials that we've ever conducted.

在大流行初期，我們非常擔心 tirzepatide 試驗已經完全註冊並且是我們進行過的一些最重要和最大的試驗。

Whether this new pandemic would cause people to stop participating in clinical trials, we didn't see a bump up in dropout rates.

這種新的流行病是否會導致人們停止參與臨床試驗，我們沒有看到輟學率上升。

I think, though, what you're really interested in is people discontinuation from therapy, which could be different than dropout rates.

不過，我認為，您真正感興趣的是人們停止治療，這可能與輟學率不同。

And we wouldn't know that until we get the data from the trial.

在我們從試驗中獲得數據之前，我們不會知道這一點。

With respect to the 2 different analyses that you comment on, the efficacy estimand versus the real intent-to-treat analysis, you're pointing out, I think that in Phase II, there was a pretty big difference between these 2 analyses, with the efficacy estimand showing better results than the pure ITT because a number of patients at the highest dose, at the 50-milligram dose, had dropped out due to adverse events.

關於你評論的兩種不同的分析，療效估計與真正的意向治療分析，你指出，我認為在第二階段，這兩種分析之間存在很大差異，與療效估計顯示比純 ITT 更好的結果，因為在最高劑量（50 毫克劑量）下，許多患者因不良事件而退出。

Like I said, we don't know what's happening in SURPASS-1 yet.

就像我說的，我們還不知道 SURPASS-1 中發生了什麼。

But when those data come, it will be important to look at those 2 analyses.

但是當這些數據到來時，看看這兩個分析是很重要的。

Our hope and the way we've designed this trial with a slower dose titration is to avoid discontinuations due to adverse events, which would show that a smaller gap between the efficacy estimand and ITT that we saw in Phase II.

我們的希望和我們設計該試驗以較慢的劑量滴定的方式是避免由於不良事件導致中止，這將表明我們在 II 期看到的療效估計值和 ITT 之間的差距較小。

Thanks, Dan.

謝謝，丹。

Mike?

麥克風？

Yes.

是的。

I can assure you that no one, in any one at Lilly, have seen the results for SURPASS-1 yet.

我可以向您保證，禮來公司的任何人都沒有看到 SURPASS-1 的結果。

I think my confidence in tirzepatide, the only thing new that we've seen is, obviously, there's been a lot of attention on the dose titration scheme that we used in our Phase II in the dose titration study as well as Phase III.

我認為我對 tirzepatide 的信心，我們看到的唯一新事物顯然是，我們在劑量滴定研究的 II 期和 III 期中使用的劑量滴定方案受到了很多關注。

We've used a more gradual titration approach in our Phase III trials.

我們在 III 期試驗中使用了更漸進的滴定方法。

And as we've seen in the readout of AWARD-11 as well as some of the Novo's step programs who used similar gradual titration, we saw that those schemes did work and that they did -- that were able to produce GI profiles that were acceptable.

正如我們在 AWARD-11 的讀數以及 Novo 的一些使用類似漸進滴定的步驟程序中看到的那樣，我們看到這些方案確實有效，而且它們確實有效——能夠產生可以接受。

So that's the new data that we've seen.

這就是我們看到的新數據。

And we're very confident in tirzepatide.

我們對替西帕肽非常有信心。

Thanks, Mike.

謝謝，邁克。

Steve, thanks for your questions.

史蒂夫，謝謝你的提問。

The next question is from Geoff Meacham from Bank of America Merrill Lynch.

下一個問題來自美銀美林的 Geoff Meacham。

Just had a few.

剛吃了幾個。

Josh, on Trulicity, if I'm hearing you correctly, for 2021, you guys have gone from mid-single to high single-digit price declines, but for the rest of the broader diabetes portfolio and really, overall, is it still mid-single as an assumption?

喬希，在 Trulicity 上，如果我沒聽錯的話，到 2021 年，你們的價格已經從中位數下降到高個位數，但對於其他更廣泛的糖尿病產品組合，總體而言，它仍然是中位數嗎？ -單作為假設？

And if you have formulary wins for Trulicity in Medicare or Medicaid but at a lower price, what's your capacity to raise price down the road?

如果您在醫療保險或醫療補助中以較低的價格贏得了 Trulicity 的處方集，那麼您未來提高價格的能力是什麼？

And then second question is just real quick.

然後第二個問題真的很快。

Wanted to ask if you're seeing any sort of halo effect in the marketplace for metastatic breast share for monarchE currently?

想問一下您目前是否在市場上看到 monarchE 轉移性乳房份額的任何形式的光環效應？

Or do you think that's going to happen looking to 2021?

或者你認為這會發生在 2021 年嗎？

Thanks, Geoff.

謝謝，傑夫。

We'll go to Josh for the questions about the overall U.S. pricing and then Anne for the question on Verzenio.

我們將向 Josh 詢問有關美國整體定價的問題，然後向 Anne 詢問有關 Verzenio 的問題。

Thanks, Geoff.

謝謝，傑夫。

Yes, on Trulicity, I think we -- as we think about 2021, we are looking at 2 separate pieces.

是的，在 Trulicity 上，我認為我們 - 當我們考慮 2021 年時，我們正在研究 2 個獨立的部分。

I think the first is just the underlying unit price where we feel things haven't changed.

我認為第一個只是我們覺得事情沒有改變的基礎單價。

We really see underlying unit price holding segments constant as being in that low to mid-single-digit impact.

我們確實認為基礎單位價格保持部分保持不變，處於低到中個位數的影響。

I think what we've seen now over 2 years is we're underestimating how fast segments like Medicaid can grow, and that's what Mike talked about.

我認為我們在兩年多的時間裡看到的是，我們低估了像醫療補助這樣的細分市場的增長速度，這就是邁克所說的。

So I think given the fact that we continue to see good growth in Medicaid, the share performance and utilization is still lower than what we see in commercial and our strong performance in that segment as well as, as we've talked in prior calls, we expect some Medicaid expansion.

因此，我認為鑑於我們繼續看到醫療補助的良好增長，股票表現和利用率仍然低於我們在商業和我們在該領域的強勁表現，以及正如我們在之前的電話會議中所說的那樣，我們預計醫療補助計劃會有所擴張。

We're seeing a little bit of that now.

我們現在看到了一點。

We expect that to persist into 2021.

我們預計這種情況將持續到 2021 年。

That moves us from that mid-single-digit Trulicity price to high single digits.

這使我們從中個位數的 Trulicity 價格上升到了高個位數。

So it really is the fact that we do continue to expect faster segment growth in areas like Medicaid.

因此，我們確實繼續期望醫療補助等領域的細分市場增長更快，這確實是一個事實。

I think -- all that being said, I think we'll continue to look at pricing as we have in the past.

我認為 - 說了這麼多，我認為我們將繼續像過去一樣關注定價。

We price for the system we have today, which is modest price -- list price increases and giving back a little bit more than that in rebates.

我們為我們今天擁有的系統定價，這是一個適中的價格——標價上漲和回饋比回扣多一點。

That's what we've seen over the last few years.

這就是我們在過去幾年看到的情況。

I don't anticipate that approach changing unless we have something that changes on the legislative side that can get us, as an industry, more toward that net price environment as opposed to high-growth rebates and net.

我預計這種方法不會改變，除非我們在立法方面有所改變，可以讓我們作為一個行業更接近淨價格環境，而不是高增長的回扣和淨價。

But for 2021, we're sort of planning that those things, at least for the beginning of the year, won't change.

但是對於 2021 年，我們在某種程度上計劃這些事情，至少在今年年初，不會改變。

Thanks, Josh.

謝謝，喬希。

Anne?

安妮？

Yes.

是的。

Thanks for the question, Geoff, on Verzenio.

感謝 Geoff 在 Verzenio 上提出的問題。

So Verzenio have had notable positive momentum right now in the currently approved metastatic breast cancer setting.

因此，Verzenio 目前在目前批准的轉移性乳腺癌環境中具有顯著的積極勢頭。

And you can see that it's steadily gaining market share.

你可以看到它正在穩步獲得市場份額。

We have monthly TRx of approaching 14% now, NBRx of approaching 23%.

我們現在每月的 TRx 接近 14%，NBRx 接近 23%。

And then you saw some of the sales being posted, particularly worldwide growth of 49%.

然後你看到了一些銷售額，特別是全球增長了 49%。

And we're now a market leader in NBRx in Japan at over 50%.

我們現在是日本 NBRx 的市場領導者，佔比超過 50%。

So definitely, momentum.

所以肯定，勢頭。

And what we continue to do is really grow the number of physicians who try Verzenio, and they continue to adopt with really a positive experience, and they incorporate it more broadly into their practice.

我們繼續做的是真正增加嘗試 Verzenio 的醫生的數量，他們繼續採用真正積極的經驗，並將其更廣泛地融入他們的實踐中。

This, I think, is primarily capitalized on the positive overall survival data from MONARCH 2 in combination with fulvestrant.

我認為，這主要是利用了 MONARCH 2 與氟維司群的積極總體生存數據。

But we do believe that the positive results from monarchE are really providing them another strong example that Verzenio is differentiated from other CDK4/6 inhibitors.

但我們確實相信 monarchE 的積極結果確實為他們提供了另一個強有力的例子，證明 Verzenio 有別於其他 CDK4/6 抑製劑。

And even prior to those results, there was a steadily growing body of evidence that Verzenio is differentiated with the higher CDK4 selectivity, differentiated continuous dosing, a monotherapy indication and then obviously, this OS data, not just in the overall population but in the primary endocrine resistance.

甚至在這些結果之前，有越來越多的證據表明 Verzenio 具有較高的 CDK4 選擇性、差異化的連續給藥、單一療法適應症，然後顯然，該 OS 數據不僅在總體人群中，而且在主要人群中內分泌抵抗。

So we do think we're seeing a shift in people's perception that this is a best-in-class opportunity, both in the metastatic setting and then potentially in the future as we bring it forward for a new treatment option for patients in the early breast cancer setting.

因此，我們確實認為我們看到人們的看法發生了轉變，即這是一個一流的機會，無論是在轉移性環境中，還是在未來，因為我們在早期為患者提供了一種新的治療選擇。乳腺癌設置。

So we look forward to more work there.

因此，我們期待在那裡開展更多工作。

Thanks, Anne.

謝謝，安妮。

Geoff, thanks for your questions.

傑夫，謝謝你的提問。

The next question is from Seamus Fernandez from Guggenheim.

下一個問題來自古根海姆的 Seamus Fernandez。

Thanks very much for the question.

非常感謝這個問題。

So one question for Dave and then a question for Josh.

給 Dave 一個問題，然後給 Josh 一個問題。

So Dave, can you talk about the key post-election policy priorities for the industry and what specifically Lilly hopes to achieve with the challenges to 340B?

那麼戴夫，您能否談談該行業在選舉後的關鍵政策重點，以及禮來公司希望通過 340B 面臨的挑戰實現什麼？

And then a question for Josh is if implemented as written, what would be the biggest impact on Lilly's corporate tax rate under the Biden tax plan?

然後喬希的一個問題是，如果按書面實施，拜登稅收計劃對禮來公司稅率的最大影響是什麼？

And is there a concern that this would have a significant relative impact on U.S. corporations like Lilly versus OUS corporations?

是否有人擔心這會對禮來（Lilly）等美國公司與 OUS 公司產生重大的相對影響？

Thanks, Seamus.

謝謝，西莫。

Dave?

戴夫？

Yes.

是的。

Thanks, Seamus.

謝謝，西莫。

Of course, the landscape post-election is not defined.

當然，選舉後的景觀並沒有定義。

So we'll need to wait for that to land before we get into too many speculations about the future environment.

因此，在我們對未來環境進行太多猜測之前，我們需要等待它落地。

But I think we can say that as an industry, as we sit around the table and certainly here at Lilly, there's 2 basic problems in the U.S. drug market that need to be untangled.

但我認為我們可以說，作為一個行業，當我們坐在桌旁，當然在禮來公司，美國藥品市場有兩個基本問題需要解決。

One is the patient out-of-pocket cost problem, where we're really the only country on the planet that indexes patient out-of-pocket cost to list prices.

一個是患者自付費用問題，我們確實是地球上唯一一個將患者自付費用索引以列出價格的國家。

That still happens highly -- in a highly prevalent way and actually, the rate of growth in high-deductible plans, including those on exchanges and ACA, is growing.

這種情況仍然非常普遍——以一種非常普遍的方式，實際上，包括交易所和 ACA 在內的高免賠額計劃的增長率正在增長。

So this problem is getting bigger, not smaller.

所以這個問題越來越大，而不是越來越小。

Of course, we think the answer there is to have cost sharing at least be based on some discounted number much closer to actual price and perhaps all the discounts being passed through.

當然，我們認為答案是成本分攤至少基於更接近實際價格的一些折扣數字，也許是所有折扣都通過了。

There's other solutions, regulatory ones, other ideas we have, capping deductibles, reducing the amount a co-pay can be for any given transaction through regulation or other avenues.

還有其他解決方案，監管的，我們有的其他想法，限制免賠額，通過監管或其他途徑減少任何給定交易的共同支付金額。

States have done that, and I think we do see good impact on affordability and persistence when that's done.

各州已經這樣做了，我認為我們確實看到了這樣做對可負擔性和持久性的良好影響。

So that's the highest priority for the industry.

因此，這是該行業的最高優先級。

The second priority, and you touched on 340B, is just reducing the amount of distortions in the system, which create artificial winners and losers and shift money around health care based on drug sales, which is inappropriate way to fund things, in our mind.

第二個優先事項，你提到了 340B，只是減少系統中的扭曲程度，這會造成人為的贏家和輸家，並根據藥品銷售將資金轉移到醫療保健上，在我們看來，這是不恰當的資助方式。

We'd like to see that disentangled and that kind of services, as it relates to dispensing or formulary management, are based on something to do with the value of those services versus something to do with the drugs that are being dispensed.

我們希望看到，與配藥或處方管理相關的那種解開的服務是基於與這些服務的價值有關的東西，而不是與正在分配的藥物有關的東西。

340B is one example of that, where high-priced drugs move through covered entities at huge margin increases.

340B 就是其中的一個例子，其中高價藥品以巨大的利潤增長通過覆蓋實體。

And those monies go to other purposes not related to the drugs.

這些錢用於與毒品無關的其他用途。

Patients pay more and lose in that equation, and we certainly lose in that equation.

患者支付更多費用並在該等式中損失，我們當然會在該等式中失敗。

So as it relates to 340B actions and other channel actions, we're interested in kind of decomplexifying that and making the system work a little bit better for, not just patients but for sustainability of the pharmaceutical industry.

因此，由於它與 340B 行動和其他渠道行動有關，我們有興趣將其分解並讓系統更好地工作，不僅為患者服務，而且為製藥行業的可持續性發展。

So anyway, we'll focus on those things as we have been.

因此，無論如何，我們將一如既往地專注於這些事情。

And we'll have to see what the tactics look like based on electoral outcomes here just a week away.

我們將不得不根據一周後的選舉結果來看看這些策略是什麼樣的。

Thanks, Dave.

謝謝，戴夫。

Josh?

喬什？

Thanks, Seamus.

謝謝，西莫。

I think, first, the tax system that we have in the U.S. now does help us compete on a global basis for innovation.

我認為，首先，我們現在在美國擁有的稅收制度確實幫助我們在全球範圍內競爭創新。

I think that's the biggest positive that we've seen.

我認為這是我們所看到的最大的積極因素。

It is a complex system.

這是一個複雜的系統。

But having a rate -- an underlying rate that's more competitive with our European competitors allows us to attract innovation, keep it in the U.S. And you've seen that in some of the acquisitions we've done, including companies like Loxo.

但是有一個利率——一個與我們的歐洲競爭對手更具競爭力的基本利率，使我們能夠吸引創新，將其留在美國。你已經在我們所做的一些收購中看到了這一點，包括像 Loxo 這樣的公司。

So we're more competitive when we're competing against OUS companies that have a low corporate tax rate in their countries.

因此，當我們與在本國企業稅率較低的 OUS 公司競爭時，我們更具競爭力。

So we like that.

所以我們喜歡這樣。

I think as we look, though, to potential changes, I think the first thing I would say is there's -- having been through the last round here, there's a huge difference between what a high-level plan is and how it gets implemented.

不過，我認為，當我們看到潛在的變化時，我想我要說的第一件事是——經歷了最後一輪，高層計劃的內容和實施方式之間存在巨大差異。

And the details in that implementation are what actually drives the big point movements.

該實施中的細節實際上是推動大點運動的原因。

I don't know that we could have, sitting in 2017, predicted that we have a 15% rate, for example, as our long-term rate here.

我不知道我們是否可以在 2017 年預測我們有 15% 的利率，例如，作為我們這裡的長期利率。

So there's a lot of work to be done if there is any kind of future tax reform coming.

因此，如果未來有任何形式的稅收改革，還有很多工作要做。

Obviously, the underlying U.S. rate looks like it'll go up.

顯然，美國的基本利率看起來會上漲。

But I think we have a couple of advantages no matter what happens.

但我認為無論發生什麼，我們都有一些優勢。

We invest heavily in R&D, among the most heavily of any of our big pharma peers.

我們在研發方面投入巨資，是我們所有大型製藥同行中投入最多的。

So we would hope and work to ensure that innovation is rewarded in any tax system going forward.

因此，我們希望並努力確保創新在未來的任何稅收制度中都能得到回報。

And we have a pretty balanced manufacturing network.

我們有一個相當平衡的製造網絡。

We make -- about half of our plants are in the U.S. and half are outside the U.S. So I think we're probably poised to take advantage of any changes that happen in the tax structure going forward.

我們製造——我們大約一半的工廠在美國，一半在美國以外。所以我認為我們可能準備好利用未來稅收結構發生的任何變化。

But there's no doubt that having a competitive sort of base rate for the U.S. relative to our OUS peers is something that's, I think, really important for our industry.

但毫無疑問，相對於我們的 OUS 同行，美國擁有具有競爭力的基本利率，我認為這對我們的行業非常重要。

Thanks, Josh.

謝謝，喬希。

Seamus, thanks for your questions.

Seamus，謝謝你的提問。

The next caller is Terence Flynn with Goldman Sachs.

下一位來電者是高盛的特倫斯·弗林。

Just regarding LOXO-305, can you share any perspective on the registration path for the drug in CLL and if a head-to-head trial versus IMBRUVICA is still on the table?

僅關於 LOXO-305，您能否分享有關 CLL 藥物註冊路徑的任何觀點，以及與 IMBRUVICA 的頭對頭試驗是否仍在討論中？

Thanks, Terence.

謝謝，特倫斯。

Dan, we'll go to you for that question.

丹，我們會問你這個問題。

Yes.

是的。

I think at this moment, it's premature to talk about registrational paths, but I can say that we look forward to releasing more data later this year.

我認為目前談論註冊路徑還為時過早，但我可以說我們期待在今年晚些時候發布更多數據。

And I think as we release that data, that's an opportunity to update on our current thinking on the development plan.

我認為當我們發布這些數據時，這是一個更新我們當前對開發計劃的想法的機會。

Thanks, Dan.

謝謝，丹。

Terence, thanks for your question.

特倫斯，謝謝你的提問。

The next question comes from David Risinger from Morgan Stanley.

下一個問題來自摩根士丹利的 David Risinger。

I just wanted to clarify.

我只是想澄清一下。

So with respect to Trulicity, I believe you said that the volume growth was 26% in the quarter.

所以關於 Trulicity，我相信你說本季度的銷量增長了 26%。

Obviously, the reported U.S. sales growth was 5%, which suggests a 21 percentage point difference.

顯然，報告的美國銷售增長率為 5%，這表明存在 21 個百分點的差異。

So either way, if that's right, if you could just confirm it, if not, if you could just give us the correct figures.

所以無論哪種方式，如果這是正確的，如果你能確認它，如果不是，如果你能給我們正確的數字。

But then could you, for the difference, explain the components?

但是，您能否解釋一下這些組件？

So obviously, last year, in the third quarter, the company had missed Trulicity sales expectations due to higher-than-expected rebates.

很明顯，去年第三季度，由於回扣高於預期，該公司未能達到 Trulicity 的銷售預期。

So the company had a very easy comparison versus the third quarter of '19 for Trulicity.

因此，該公司與 19 年第三季度的 Trulicity 進行了非常簡單的比較。

Yet, obviously, the sales disappointed this quarter.

然而，顯然，本季度的銷售額令人失望。

So if you could explain that 20%-plus percentage point difference in terms of how much was due to rebates versus mix shift, et cetera.

因此，如果您能解釋 20% 以上的百分點差異是由於回扣與混合轉移等原因造成的。

And then also help us understand why the mix shift was a surprise given the Medicaid wins that you articulated.

然後還幫助我們理解為什麼考慮到您所闡述的醫療補助計劃的勝利，混合轉變是一個驚喜。

And then -- well, actually, I'll just leave it at that.

然後——好吧，實際上，我就這樣吧。

So if you could address those, that would be great.

所以如果你能解決這些問題，那就太好了。

Thanks, Dave.

謝謝，戴夫。

We'll go to Mike Mason for that.

我們會去找邁克梅森。

Thanks for the question.

謝謝你的問題。

As we take a look at pricing performance for Trulicity in Q3, when we take a look at the net impact of increased rebates to maintain access and list price, that was a 2%, a modest headwind in Q3 of this year.

當我們查看 Trulicity 在第三季度的定價表現時，當我們查看增加回扣以維持訪問和定價的淨影響時，這是 2%，這是今年第三季度的適度逆風。

Segment mix was 6% and then the remaining of that was due to onetime events due to coverage GAAP estimates for rebates and discounts.

細分市場組合為 6%，其餘部分是由於 GAAP 對回扣和折扣的覆蓋率估計而導致的一次性事件。

So that's the breakdown of performance for Trulicity in Q3.

這就是第三季度 Trulicity 的業績細分。

As you -- you may not have been on earlier.

就像你一樣——你可能之前沒有上過。

As we take a look at Medicaid performance, we're performing quite well in the higher-priced segments of commercial and Part D. We grew gross sales in commercial by 29% year-to-date and Part D by 44%.

當我們看一下醫療補助的表現時，我們在商業和 D 部分的高價部分錶現相當不錯。今年迄今為止，我們在商業和 D 部分的總銷售額增長了 29%，增長了 44%。

When we take a look at segment mix, it's really driven by higher-than-expected Medicaid.

當我們看一下細分市場組合時，它實際上是由高於預期的醫療補助推動的。

We really have kind of a triple whammy going there, where, as you say, COVID is driving more people into Medicaid.

我們真的有一種三重打擊在那裡，正如你所說，COVID正在推動更多的人進入醫療補助計劃。

We're also seeing that Medicaid, in general, is growing for Trulicity because Trulicity's share is lower.

我們還看到，總體而言，Trulicity 的醫療補助正在增長，因為 Trulicity 的份額較低。

And then we did make the conscious decision to win access in Medicaid because we felt that we're going to see people going from commercial to Medicaid.

然後我們確實做出了有意識的決定來贏得醫療補助，因為我們覺得我們將看到人們從商業轉向醫療補助。

And we had a lower access in Medicaid than we did in commercial.

而且我們在 Medicaid 中的訪問權限比在商業中的訪問權限要低。

So we thought it was the right thing to do for patients in order to increase Medicaid so someone didn't have to go off Trulicity if they lost their job during the pandemic.

因此，我們認為為患者增加醫療補助是正確的做法，這樣如果有人在大流行期間失業，他們就不必離開 Trulicity。

So that's the breakdown.

所以這就是故障。

We're very confident in Trulicity, both pricing and volume going forward.

我們對 Trulicity 非常有信心，無論是定價還是銷量。

Thanks, Mike.

謝謝，邁克。

Dave, thanks for your question.

戴夫，謝謝你的提問。

And next question will come from Vamil Divan from Mizuho.

下一個問題將來自瑞穗的 Vamil Divan。

So just 2, please.

所以只有2，拜託。

One on tanezumab.

一個關於 tanezumab。

I know you mentioned the AdCom.

我知道你提到了 AdCom。

I believe that's a change from before when the FDA was saying that they were not going to do an AdCom.

我相信這與之前 FDA 說他們不會進行 AdCom 的情況有所不同。

I don't know if you have any insights you can share just on what may have changed to led -- to leave them to do the advisory committee meeting?

我不知道您是否有任何見解可以分享，就可能已更改為領導 - 讓他們參加諮詢委員會會議？

And then second on -- maybe just going back to the Alzheimer's discussion from before.

然後第二個 - 也許只是回到以前的阿爾茨海默氏症討論。

Obviously, a lot of focus on donanemab early next year.

顯然，明年年初很多人都將注意力集中在多那麥上。

I know you also have an N3pG in Phase I development.

我知道您在第一階段開發中也有 N3pG。

I'm just curious if you can maybe talk about sort of how that one is different from the one you have in late Phase II to give us a sense of what you're trying to change their potential.

我只是想知道你是否可以談談那個與你在第二階段後期所擁有的有什麼不同，讓我們了解你試圖改變他們的潛力。

Thanks, Vamil.

謝謝，瓦米爾。

We'll go to Patrik for the question about tanezumab and then Dan for the question on N3pG in Phase I.

我們將向 Patrik 詢問有關 tanezumab 的問題，然後向 Dan 詢問有關第一階段 N3pG 的問題。

Well, thank you very much for the question.

嗯，非常感謝你的提問。

We were just updated by the FDA that the PDUFA date is no longer valid and that they are most likely planning to have an advisory board in the month of March.

FDA 剛剛更新我們，PDUFA 日期不再有效，他們很可能計劃在 3 月份設立一個諮詢委員會。

And actually, we don't believe this is necessarily negative, taking into account that we have a lot of data on tanezumab.

實際上，考慮到我們有大量關於 tanezumab 的數據，我們認為這不一定是負面的。

And we have 39 clinical trials and more than 18,000 patients treated.

我們有 39 項臨床試驗和超過 18,000 名患者接受治療。

So we actually think even an ad board could be beneficial.

所以我們實際上認為即使是廣告板也可能是有益的。

Thanks, Patrik.

謝謝，帕特里克。

Dan?

擔？

Sure.

當然。

Vamil, thanks for the question on donanemab and the follow-on in N3pG molecule, which you noted is in Phase I. One of the things that we saw with donanemab was that we had a great PD effect.

Vamil，感謝有關 donanemab 和 N3pG 分子的後續問題的問題，您注意到它處於第一階段。我們在 donanemab 中看到的一件事是我們有很好的 PD 效果。

We could clear plaques quite deeply and quickly, but we also had antidrug antibodies.

我們可以非常深入和快速地清除斑塊，但我們也有抗藥抗體。

The antibodies weren't at a level that they affected the PK of the drug because we're giving pretty high doses of the drug.

抗體沒有達到影響藥物 PK 的水平，因為我們給予了相當高劑量的藥物。

Still, it's not optimal to have ADA against your drug.

儘管如此，讓 ADA 對抗您的藥物並不是最佳選擇。

So we created a next-gen N3pG that we hypothesized would have the same plaque-clearing PD effect but not have antidrug antibodies.

因此，我們創建了下一代 N3pG，我們假設它具有相同的斑塊清除 PD 效果，但沒有抗藥抗體。

So that's the next one that you see there in Phase I. If donanemab turns out to be a success, it could be useful to have a follow-on molecule that doesn't have ADA.

所以這是你在第一階段看到的下一個。如果多納奈馬成功了，那麼擁有一個沒有 ADA 的後續分子可能會很有用。

I also point out that in addition to donanemab and that followed-on N3pG molecule, the other Alzheimer's molecule we're really quite excited about is zagotenemab, which is our aggregated tau-specific antibody.

我還指出，除了 donanemab 和隨後的 N3pG 分子之外，我們非常興奮的另一個阿爾茨海默氏症分子是 zagotenemab，它是我們的聚合 tau 特異性抗體。

And that will be reading out later next year.

這將在明年晚些時候公佈。

Thanks, Dan.

謝謝，丹。

Vamil, thanks for your questions.

瓦米爾，謝謝你的提問。

And now we'll go back to Dave for the close.

現在我們將回到戴夫結束。

Great.

偉大的。

Thanks, Kevin.

謝謝，凱文。

Well, we appreciate everyone's participation in today's earnings call and your ongoing interest in Eli Lilly and Company.

好吧，我們感謝大家參與今天的財報電話會議以及您對禮來公司的持續關注。

Please follow up with the IR team if you have questions that were not addressed today.

如果您有今天未解決的問題，請與 IR 團隊聯繫。

And I hope everyone stays well during this difficult time.

我希望每個人都能在這個困難時期保持健康。

Take care, and we'll be in touch.

保重，我們會與您聯繫。

Thank you.

謝謝你。

And ladies and gentlemen, that does conclude our conference for today.

女士們先生們，今天的會議到此結束。

Thank you for your participation and for using AT&T conferencing services.

感謝您的參與和使用 AT&T 會議服務。

You may now disconnect.

您現在可以斷開連接。