禮來公司 (LLY) 2021 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the Lilly Quarter 3 2021 Earnings Call.

女士們先生們，感謝您的支持並歡迎參加禮來公司 2021 年第 3 季度財報電話會議。

(Operator Instructions)

（操作員說明）

As a reminder, today's conference is being recorded.

提醒一下，今天的會議正在錄製中。

I would now like to turn the conference over to your host, Vice President of Investor Relations, Kevin Hern.

我現在想將會議轉交給您的主持人，投資者關係副總裁 Kevin Hern。

Please go ahead.

請繼續。

Good morning.

早上好。

Thank you for joining us for Eli Lilly and Company's Q3 2021 earnings call.

感謝您參加禮來公司 2021 年第三季度財報電話會議。

I'm Kevin Hern, VP 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; Anat Ashkenazi, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific and Medical Officer; Anne White, President of Lilly Neuroscience; Jake Van Naarden, CEO of Loxo Oncology at Lilly and President of Lilly Oncology; Patrik Jonsson, President of Lilly Immunology and Lilly U.S.A.; and Mike Mason, President of Lilly Diabetes.

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）； Anat Ashkenazi，首席財務官； Dan Skovronsky 博士，首席科學和醫學官；禮來公司神經科學總裁 Anne White； Jake Van Naarden，禮來公司 Loxo 腫瘤學首席執行官兼禮來腫瘤學總裁； Patrik Jonsson，禮來免疫學和禮來美國公司總裁；和禮來糖尿病公司總裁 Mike Mason。

We're also joined by Lauren Zierke, Kento Ueha and Sara Smith of the Investor Relations team.

投資者關係團隊的 Lauren Zierke、Kento Ueha 和 Sara Smith 也加入了我們的行列。

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

在本次電話會議期間，我們預計會根據當前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 listed on Slide 3. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission.

由於多種因素，包括幻燈片 3 中列出的因素，我們的實際結果可能存在重大差異。有關可能導致實際結果產生重大差異的因素的其他信息包含在我們最新的 10-K 表格和後續 10-Q 和 8- 表格中K 向證券交易委員會提交了申請。

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, a reminder that our commentary will focus on non-GAAP financial measures.

當我們過渡到我們準備好的評論時，提醒我們的評論將集中在非公認會計準則財務指標上。

Now I'll turn the call over to Dave for a summary of our third quarter results.

現在，我將把電話轉給戴夫，以獲得我們第三季度業績的摘要。

Thanks, Kevin.

謝謝，凱文。

Once again, Lilly had a very strong quarter, growing our newest medicines around the world and continuing to advance significant potential new medicines in the late-stage development while also building long-term opportunities through early-stage investments in technology and progress in early-stage programs.

禮來（Lilly）又一次取得了非常強勁的季度業績，在全球範圍內種植我們最新的藥物，並在後期開發中繼續推進具有重要潛力的新藥，同時還通過早期技術投資和早期進展創造長期機會舞台節目。

Q3 2021 was also a period where the resilience of our company, our people and collaborators were tested by the pandemic.

2021 年第三季度也是我們公司、我們的員工和合作者的複原力受到大流行考驗的時期。

And again, they rose to the challenge.

他們再次迎接挑戰。

I want to personally recognize and thank my Lilly teammates for delivering such a strong overall performance, innovating to maintain pipeline velocity, running our plants to meet the rapidly growing demand of medicines and continuing to serve our customers, whether it be in person or online.

我要親自認可並感謝我的禮來（Lilly）隊友提供如此出色的整體表現、創新以保持管道速度、運營我們的工廠以滿足快速增長的藥品需求並繼續為我們的客戶提供服務，無論是面對面還是在線。

Turning to our strategic deliverables on Slide 4. Q3 revenue grew 18% compared to Q3 2020 or 17% in constant currency.

轉向我們在幻燈片 4 上的戰略可交付成果。與 2020 年第三季度相比，第三季度的收入增長了 18%，按固定匯率計算增長了 17%。

This performance was driven entirely by volume.

這種表現完全是由數量驅動的。

Volume growth was 17 percentage points.

銷量增長 17 個百分點。

When excluding COVID-19 therapies, which includes revenue from COVID-19 antibodies and sales of Olumiant for the treatment of COVID-19, revenue grew an estimated 11% for the quarter and year-to-date.

如果不包括 COVID-19療法，其中包括來自 COVID-19抗體的收入和用於治療 COVID-19的 Olumiant 的銷售，本季度和年初至今的收入估計增長了 11%。

Revenue attributable to our newer medicines grew over 35% and now represents nearly 60% of our core business this quarter, an important indicator for our long-term growth potential.

我們新藥的收入增長了 35% 以上，現在占我們本季度核心業務的近 60%，這是我們長期增長潛力的重要指標。

Our non-GAAP gross margin was 79% in Q3 or 79.3% excluding for the impact of foreign exchange on international inventories sold.

我們第三季度的非美國通用會計準則毛利率為 79% 或 79.3%，不包括外匯對已售國際庫存的影響。

Excluding this FX impact, our gross margin decreased by approximately 60 basis points compared to last year.

排除這種外匯影響，我們的毛利率與去年相比下降了約 60 個基點。

Our non-GAAP operating margin was 30.5%, representing an improvement of over 400 basis points compared to Q3 of last year and over 100 basis points of sequential improvement from Q2 of this year.

我們的非美國通用會計準則營業利潤率為 30.5%，與去年第三季度相比提高了 400 多個基點，比今年第二季度連續提高了 100 多個基點。

We had a number of significant pipeline milestones since our last earnings call in August, including the FDA approvals for Verzenio in certain people with high-risk early breast cancer; and for Jardiance in collaboration with Boehringer Ingelheim in heart failure with reduced ejection fraction; regulatory submissions for tirzepatide for type 2 diabetes in the U.S., to which we applied a Priority Review Voucher, as well as the EU; and Jardiance in heart failure with preserved ejection fraction.

自 8 月份的上一次財報電話會議以來，我們有許多重要的管道里程碑，包括 FDA 批准 Verzenio 用於某些高危早期乳腺癌患者； Jardiance 與勃林格殷格翰合作治療射血分數降低的心力衰竭； tirzepatide 在美國和歐盟的監管提交，我們對其應用了優先審查憑證；和保留射血分數的心力衰竭的 Jardiance。

We initiated a rolling submission in the U.S. for donanemab in early Alzheimer's disease and had positive Phase III readouts for lebrikizumab in atopic dermatitis.

我們在美國發起了一項針對早期阿爾茨海默病的多納尼單抗的滾動提交，並在特應性皮炎中獲得了 lebrikizumab 的 III 期陽性讀數。

We also continued to augment our pipeline with business development opportunities as we continued to leverage external innovation to build our discovery capabilities with a focus on new modalities at Lilly.

隨著我們繼續利用外部創新來建立我們的發現能力，並專注於禮來公司的新模式，我們還繼續通過業務發展機會擴大我們的管道。

In Q3, we announced a research collaboration and license agreement with Lycia Therapeutics to utilize their proprietary protein degradation technology.

在第三季度，我們宣布與 Lycia Therapeutics 達成研究合作和許可協議，以利用其專有的蛋白質降解技術。

Finally, on financials, we distributed nearly $800 million to shareholders via the dividend this quarter.

最後，在財務方面，我們通過本季度的股息向股東分配了近 8 億美元。

Moving to slides 5 and 6, you'll see a list of key events since our Q2 earnings call, including issuing the company's first sustainability bond with proceeds allocated toward environmental projects, including pollution prevention, energy efficiency and renewable energy, as well as social projects to increase access to essential services and socioeconomic advancement and empowerment.

轉到幻燈片 5 和 6，您將看到自我們第二季度財報電話會議以來的一系列關鍵事件，包括發行公司首個可持續發展債券，收益分配給環境項目，包括污染預防、能源效率和可再生能源，以及社會增加獲得基本服務和社會經濟進步和賦權的項目。

We announced a series of leadership and organizational changes this quarter.

我們在本季度宣布了一系列領導和組織變革。

Recent positive data readouts this year led us to the natural decision to increase our focus on immunology and neuroscience and to unify the Loxo Oncology and Lilly Oncology organizations.

今年最近公佈的積極數據使我們自然而然地決定增加對免疫學和神經科學的關注，並統一 Loxo 腫瘤學和禮來腫瘤學組織。

We believe these changes enhance our ability to execute on a broad range of exciting commercial and pipeline opportunities.

我們相信，這些變化增強了我們執行各種令人興奮的商業和管道機會的能力。

I'd like to welcome Jake Van Naarden to Lilly's Executive Committee and look forward to Anne, Patrik and Jake continuing their leadership in their new roles.

我歡迎 Jake Van Naarden 加入禮來公司的執行委員會，並期待 Anne、Patrik 和 Jake 繼續在他們的新角色中發揮領導作用。

They'll be focused on increasing our competitiveness in their therapeutic areas and growing our existing medicines while also launching our late-stage pipeline of new medicines, which could benefit patients across a diverse set of medical conditions.

他們將專注於提高我們在其治療領域的競爭力和發展我們現有的藥物，同時推出我們的新藥後期管道，這可能使患者受益於各種醫療條件。

Similarly, I'm grateful for Ilya's continued leadership and look forward to him leading our growing international business.

同樣，我感謝 Ilya 的持續領導，並期待他領導我們不斷發展的國際業務。

Finally, I'd like to thank Chito Zulueta for his impact on our company across more than 3 decades of his commitment to patients, the development of our industry-leading commercial capabilities and his relentless focus on execution and mentorship of countless Lilly leaders.

最後，我要感謝 Chito Zulueta 在 3 多年的時間裡對我們公司的影響，他對患者的承諾、我們行業領先的商業能力的發展以及他對無數禮來領導人的執行和指導的不懈關注。

Chito, thank you for your service to our company.

Chito，感謝您對我們公司的服務。

We have a deep leadership bench here at Lilly.

我們在禮來 (Lilly) 擁有深厚的領導層。

They're smart, they're energetic and experienced.

他們很聰明，精力充沛，經驗豐富。

And I know they're as excited as I am to take Lilly to another level in the decade ahead.

而且我知道他們和我一樣興奮地在未來十年將禮來公司提升到另一個水平。

Now I'll turn the call over to Anat to review our Q3 results and provide an update on our financial guidance for 2021.

現在，我將把電話轉給 Anat，以審查我們的第三季度業績，並提供我們 2021 年財務指導的最新信息。

Thanks, Dave.

謝謝，戴夫。

Slides 7 and 8 summarize financial performance in the third quarter and year-to-date.

幻燈片 7 和 8 總結了第三季度和年初至今的財務業績。

I'll focus my comments on non-GAAP performance.

我將把我的評論集中在非公認會計原則的表現上。

Revenue increased 18% this quarter compared to Q3 2020 or 11% excluding the items Dave mentioned earlier, representing strong momentum for our core business despite the impact of Alimta's OUS patent expiry.

與 2020 年第三季度相比，本季度的收入增長了 18%，或者不包括 Dave 前面提到的項目，增長了 11%，儘管受到 Alimta 的 OUS 專利到期的影響，但我們的核心業務發展勢頭強勁。

We continue to be pleased with the strong volume growth across key brands like Trulicity, Taltz, Verzenio and Jardiance as our key growth products made up nearly 60% of our core business during the quarter.

我們繼續對 Trulicity、Taltz、Verzenio 和 Jardiance 等主要品牌的強勁銷量增長感到滿意，因為我們的主要增長產品在本季度占我們核心業務的近 60%。

Gross margin as a percent of revenue declined 10 basis points to 79% in Q3.

第三季度毛利率佔收入的百分比下降了 10 個基點至 79%。

Favorable product mix, excluding COVID-19 therapies, and a favorable impact from foreign exchange rates on international inventories sold were more than offset by lower gross margin on COVID-19 therapies.

有利的產品組合（不包括 COVID-19 療法）以及外匯匯率對銷售的國際庫存的有利影響被 COVID-19 療法的較低毛利率所抵消。

Total operating expenses grew 8% this quarter compared to the same quarter last year.

與去年同期相比，本季度總運營費用增長了 8%。

Marketing, selling and administrative expenses increased 1%, while R&D expenses increased 17% driven by significant investments in exciting late-stage pipeline opportunities, including donanemab, pirtobrutinib and tirzepatide.

營銷、銷售和行政費用增長了 1%，而研發費用增長了 17%，這是由於對激動人心的後期管道機會的大量投資，包括多納奈馬、吡托布替尼和替西帕肽。

We also invested approximately $50 million in research and development for COVID-19 therapies in Q3, bringing our total COVID-19 R&D investments to approximately $350 million year-to-date.

我們還在第三季度投資了約 5000 萬美元用於 COVID-19 療法的研發，使我們的 COVID-19 研發總投資達到約 3.5 億美元。

Operating income increased 37% compared to Q3 2020, and operating income as a percent of revenue was 30.5% for the quarter, an increase of 420 basis points compared to the prior year, with sequential growth for a second straight quarter.

與 2020 年第三季度相比，營業收入增長了 37%，本季度營業收入佔收入的百分比為 30.5%，與去年同期相比增加了 420 個基點，連續第二個季度環比增長。

This increase was driven by revenue growth outpacing expense growth, and we expect continued margin expansion in the fourth quarter.

這一增長是由收入增長超過費用增長推動的，我們預計第四季度利潤率將繼續增長。

Other income and expense was expense of $7 million for this quarter, compared to income of $10 million in Q3 2020.

本季度的其他收入和支出為 700 萬美元，而 2020 年第三季度的收入為 1000 萬美元。

Our effective tax rate was 14.3%, a decrease of 70 basis points compared with the same quarter last year.

我們的有效稅率為 14.3%，與去年同期相比下降了 70 個基點。

The lower effective tax rate in the third quarter of 2021 was driven by a mix of earnings in lower tax jurisdictions, partially offset by a decrease in net discrete tax benefits compared to the same period in 2020.

2021 年第三季度較低的有效稅率是由較低稅收管轄區的混合收益推動的，但與 2020 年同期相比，淨離散稅收優惠的減少部分抵消了這一影響。

At the bottom line, we delivered strong growth as earnings per share increased 38% in Q3 2021.

歸根結底，我們實現了強勁的增長，因為每股收益在 2021 年第三季度增長了 38%。

On Slide 9, we quantify the effect of price, rate and volume on revenue growth, and we're encouraged by the growth seen across the world.

在幻燈片 9 中，我們量化了價格、費率和數量對收入增長的影響，我們對全球範圍內的增長感到鼓舞。

This quarter, U.S. revenue grew 26% compared to third quarter of 2020.

本季度，美國收入與 2020 年第三季度相比增長了 26%。

Adjusting for revenue from COVID-19 therapies, revenue grew 14% in the U.S. This increase, driven largely by volume, was led by Trulicity, Taltz, Jardiance and Verzenio.

根據 COVID-19 療法的收入進行調整後，美國的收入增長了 14%。這一增長主要受銷量驅動，由 Trulicity、Taltz、Jardiance 和 Verzenio 引領。

The higher net realized price in the U.S. this quarter was driven by lower utilization in the 340B segment, unfavorable changes to estimates for rebates and discounts for Trulicity in the third quarter of 2020 and modest list price increases, partially offset by increased rebates, to maintain broad patient access for our medicine.

本季度美國淨實現價格較高的原因是 340B 細分市場的利用率較低、2020 年第三季度對 Trulicity 的回扣和折扣估計的不利變化以及適度的標價上漲（部分被回扣增加所抵消）以維持廣泛的患者使用我們的藥物。

Our year-to-date U.S. net price decrease of 1% is in line with the low to mid-single-digit guidance we gave last December, and our full year outlook is consistent with those expectations.

我們年初至今的美國淨價格下降 1% 符合我們去年 12 月給出的中低個位數指導，我們的全年展望與這些預期一致。

Our 340B limited distribution program began September 2020, and so the fourth quarter of 2021 will be the first full quarter where its impact will also be included in the base period when calculating year-over-year price changes in the U.S. Given the increase in variability in payer mix, we continue to expect quarterly variability in reported U.S. net price changes across our business.

我們的 340B 有限分銷計劃於 2020 年 9 月開始，因此 2021 年第四季度將是第一個完整季度，在計算美國的同比價格變化時，其影響也將包含在基期中。鑑於可變性的增加在付款人組合中，我們繼續預計我們業務中報告的美國淨價格變化的季度變化。

Moving to Europe.

搬到歐洲。

Revenue grew 3% in constant currency.

按固定匯率計算，收入增長了 3%。

Excluding the impact of the first full quarter of loss of exclusivity for Alimta, revenue grew 16% in constant currency driven primarily by volume growth for Trulicity, Taltz and Verzenio.

排除第一季度失去 Alimta 獨家經營權的影響，按固定匯率計算，收入增長了 16%，主要受 Trulicity、Taltz 和 Verzenio 銷量增長的推動。

We are pleased with the momentum of our business in Europe and expect continued growth excluding Alimta.

我們對我們在歐洲的業務發展勢頭感到滿意，並預計不包括 Alimta 將繼續增長。

In Japan, revenue decreased 6% in constant currency driven primarily by the decline of post-patent products.

在日本，主要由於專利後產品的下降，按固定匯率計算的收入下降了 6%。

Revenue in Japan continues to be negatively impacted by decreased demand for several products that have lost market exclusivity, now including Alimta, as well as by the COVID-19 pandemic.

日本的收入繼續受到對失去市場獨占性的幾種產品（現在包括 Alimta）的需求減少以及 COVID-19 大流行的負面影響。

Importantly, our key growth products grew 12% in Q3 in Japan.

重要的是，我們的主要增長產品在第三季度在日本增長了 12%。

We expect improved revenue growth in Japan moving forward based on the uptake of these newer products.

我們預計，基於這些新產品的採用，日本的收入增長將有所改善。

In China, revenue grew 30% in constant currency primarily driven by continued uptake of Tyvyt and Trulicity.

在中國，以固定匯率計算的收入增長了 30%，這主要是由於 Tyvyt 和 Trulicity 的持續採用。

We're excited by the significant growth we're seeing in China with sales of new medicines continuing to drive growth there.

我們對我們在中國看到的顯著增長感到興奮，新藥的銷售繼續推動那裡的增長。

Revenue in the rest of the world increased 16% in constant currency driven primarily by our key growth products.

世界其他地區的收入按固定匯率計算增長了 16%，主要受我們主要增長產品的推動。

At the bottom of the slide is the price, rate and volume effect on revenue for our September year-to-date results, which shows double-digit growth across all major geographies except Japan.

幻燈片底部是我們 9 月份年初至今業績的價格、費率和銷量對收入的影響，顯示除日本以外的所有主要地區都有兩位數的增長。

As shown on Slide 10, our key growth products continue to drive strong worldwide volume growth.

如幻燈片 10 所示，我們的主要增長產品繼續推動全球銷量的強勁增長。

These products drove 15 percentage point of growth this quarter and continue to drive our overall performance and outlook.

這些產品在本季度推動了 15 個百分點的增長，並繼續推動我們的整體業績和前景。

Slide 11 highlights the contributions of our key growth products.

幻燈片 11 突出了我們主要增長產品的貢獻。

In total, these brands generated nearly $3.9 billion in revenue this quarter and made up 58% of our core business revenue.

這些品牌本季度總共創造了近 39 億美元的收入，占我們核心業務收入的 58%。

We are encouraged by the strength of our key growth products in Q3, collectively up over 35% compared to the same period in prior year.

我們對第三季度主要增長產品的強勁表現感到鼓舞，與去年同期相比總共增長了 35% 以上。

Trulicity, Verzenio and Jardiance all continue to outgrow their respective classes, and we're pleased with Taltz's growth driven by increased access.

Trulicity、Verzenio 和 Jardiance 都繼續超過各自的班級，我們對 Taltz 的增長感到高興，因為訪問量增加了。

On Slide 12, we provide an update on capital allocation.

在幻燈片 12 中，我們提供了資本配置的最新信息。

In the first 9 months of 2021, we invested $7 billion to drive our future growth through a combination of R&D expenditures, business development outlays and capital investments.

在 2021 年的前 9 個月，我們投資了 70 億美元，通過結合研發支出、業務發展支出和資本投資來推動我們未來的增長。

In addition, we returned over $2.3 billion to shareholders in dividends and have repurchased $500 million in stock.

此外，我們向股東返還了超過 23 億美元的股息，並回購了 5 億美元的股票。

We will continue to fund the growth of our key products and recent launches, invest in our pipeline, seek external innovation to augment our future growth prospects and return capital to shareholders.

我們將繼續為我們的主要產品和最近推出的產品的增長提供資金，投資我們的管道，尋求外部創新以擴大我們未來的增長前景並向股東返還資本。

Turning to our 2021 financial guidance on Slide 13, we're updating our GAAP and non-GAAP guidance.

關於幻燈片 13 的 2021 年財務指導，我們正在更新我們的 GAAP 和非 GAAP 指導。

We're increasing the full year revenue outlook by $200 million at the top end of the range and $400 million at the lower end of the range to reflect additional COVID-19 antibody revenue and the outlook for our core business.

我們將全年收入前景在該範圍的上限提高 2 億美元，在該範圍的下限提高 4 億美元，以反映額外的 COVID-19抗體收入和我們核心業務的前景。

COVID-19 antibody revenue expectations are roughly $1.3 billion based on the existing U.S. government purchase agreement for additional doses of etesevimab in Q3 and Q4.

根據現有的美國政府在第三季度和第四季度額外劑量的 etesevimab 購買協議，COVID-19抗體收入預期約為 13 億美元。

The net impact of these changes is an updated revenue range of $27.2 billion to $27.6 billion, up from the previous range of $26.8 billion to $27.4 billion.

這些變化的淨影響是更新後的收入範圍為 272 億美元至 276 億美元，高於之前的 268 億美元至 274 億美元。

Our outlook for GAAP and non-GAAP gross margin percent remains unchanged.

我們對 GAAP 和非 GAAP 毛利率百分比的展望保持不變。

For research and development and SG&A, our guidance ranges remain unchanged.

對於研發和 SG&A，我們的指導範圍保持不變。

As we noted last quarter, investments in promising R&D opportunities and exciting potential launches are expected to push us to the top end of our guidance range for operating expenses.

正如我們上個季度所指出的那樣，對有前景的研發機會和令人興奮的潛在發布的投資預計將把我們推向我們運營費用指導範圍的高端。

Our reported and non-GAAP operating margin guidance is unchanged.

我們報告的和非公認會計原則的營業利潤率指引保持不變。

Excluding the impact of COVID-19 antibodies, non-GAAP operating margin remains approximately 31%.

排除 COVID-19 抗體的影響，非 GAAP 營業利潤率仍約為 31%。

Our non-GAAP ranges for other income and expense and our expected tax rate remain unchanged as well.

我們的其他收入和費用的非公認會計原則範圍以及我們的預期稅率也保持不變。

On a reported basis, other income and expense is now expected to be expense in the range of $250 million to $150 million, reflecting the impact of the charges associated with the repurchase of debt and net mark-to-market losses on investments in equity securities in the third quarter of 2021.

根據報告，其他收入和費用現在預計在 2.5 億美元至 1.5 億美元之間，反映了與債務回購相關的費用和按市值計價的淨損失對股票證券投資的影響在 2021 年第三季度。

The 2021 effective tax rate is now expected to be approximately 11% on a reported basis, reflecting the tax impact of the charges associated with the repurchase of debt and acquired IP R&D as well as unfavorable mark-to-market adjustments on investments in equity securities in the third quarter of 2021.

目前預計 2021 年有效稅率約為 11%，這反映了與回購債務和獲得的知識產權研發相關的費用以及對股權證券投資的不利按市值調整的稅收影響在 2021 年第三季度。

Finally, the non-GAAP range for earnings per share has been raised to $7.95 to $8.05, while the GAAP EPS is expected to be in the range of $6.38 to $6.48.

最後，每股收益的非公認會計原則範圍已上調至 7.95 美元至 8.05 美元，而公認會計原則每股收益預計將在 6.38 美元至 6.48 美元之間。

At our Investors' Day in December, we will share our initial 2022 guidance.

在 12 月的投資者日，我們將分享我們最初的 2022 年指導。

Today, before I turn the call over to Dan for the R&D update, I'd like to provide a few reminders on the pushes and pulls across the P&L as you begin thinking about next year.

今天，在我將電話轉給 Dan 進行研發更新之前，我想在您開始考慮明年時提供一些關於 P&L 的推動和拉動的提醒。

In Q3, we saw the initial impact of Alimta's OUS patent expiry in Europe and Japan.

在第三季度，我們看到了 Alimta 的 OUS 專利到期對歐洲和日本的初步影響。

Next year, we will see its full year impact as well as the U.S. patent expiry with limited launches from a single generic company in Q1 before the full launch of generic entrants starting in Q2.

明年，我們將看到其全年影響以及美國專利到期，第一季度單一仿製藥公司有限推出，然後從第二季度開始全面推出仿製藥進入者。

As for revenue from COVID-19 therapies, we intend to reflect in guidance our expectations related to signed purchase agreements for COVID-19 antibodies.

至於 COVID-19 療法的收入，我們打算在指導中反映我們對簽署的 COVID-19 抗體購買協議的預期。

Currently, we expect minimal revenue from COVID-19 therapies in 2022, leading to more difficult year-over-year comparisons.

目前，我們預計 2022 年 COVID-19 療法的收入將微乎其微，導致同比比較更加困難。

As we did this year, we will provide commentary on our financials excluding the impact of revenue and certain expenses from COVID-19 therapies to enable a more helpful year-over-year comparison of the performance of our core business.

正如我們今年所做的那樣，我們將對我們的財務狀況提供評論，不包括 COVID-19 療法的收入和某些費用的影響，以便對我們的核心業務的業績進行更有用的年度比較。

Absent major U.S. drug pricing reform, our 2022 and midterm outlook continues to be mid-single-digit net price erosion in the U.S. and globally as the impact of lower utilization of 340B segment move into the base case period as we enter Q4 2021.

在美國沒有重大的藥品定價改革的情況下，隨著我們進入 2021 年第四季度，隨著 340B 細分市場利用率下降的影響進入基本案例期，我們的 2022 年和中期前景繼續在美國和全球範圍內出現中個位數的淨價格侵蝕。

We continue to invest in our bright future as we advance promising R&D opportunities and scale up to support exciting potential launches from our late-stage pipeline.

隨著我們推進有前途的研發機會並擴大規模以支持我們後期管道中令人興奮的潛在發布，我們將繼續投資於我們光明的未來。

While these investments may pressure our operating margin in the near term, they are critical to maximizing pipeline opportunities to help sustain top-tier revenue growth and operating margin expansion over the mid to long term.

雖然這些投資可能會在短期內給我們的營業利潤率帶來壓力，但它們對於最大限度地利用管道機會以幫助維持中長期的頂級收入增長和營業利潤率擴張至關重要。

Now I'll turn over the call to Dan to provide an update on our pipeline.

現在，我將把電話轉給 Dan，以提供有關我們管道的更新。

Thanks, Anat.

謝謝，阿納特。

Like 2020 before, 2021 continues to be a very productive year for R&D at Lilly.

與之前的 2020 年一樣，2021 年對於禮來的研發來說仍然是非常富有成效的一年。

Before I get into the broader portfolio update, I'll highlight several updates from our late-stage pipeline, starting with tirzepatide.

在進入更廣泛的產品組合更新之前，我將重點介紹我們後期管道中的幾個更新，從 tirzepatide 開始。

We shared detailed results from tirzepatide's SURPASS-4 study at EASD this quarter.

我們在本季度的 EASD 上分享了 tirzepatide 的 SURPASS-4 研究的詳細結果。

SURPASS-4 is the largest and longest SURPASS trial completed to date, and we were encouraged by the continued hemoglobin A1C and weight control which participants experienced even past the initial 52-week treatment period and continuing up to 2 years.

SURPASS-4 是迄今為止完成的最大和最長的 SURPASS 試驗，我們對持續的血紅蛋白 A1C 和體重控制感到鼓舞，參與者甚至在最初的 52 周治療期之後並持續長達 2 年。

Looking at Slide 14, this shows the change from baseline in hemoglobin A1C over time during the study.

查看幻燈片 14，這顯示了研究期間血紅蛋白 A1C 與基線相比隨時間的變化。

A1C reduction plateaued by roughly 24 weeks and was maintained at 52 weeks and thereafter to 104 weeks across all 3 tirzepatide doses.

A1C 降低在大約 24 週內達到穩定水平，並在所有 3 次 tirzepatide 劑量中維持在 52 周和此後至 104 週。

While in the insulin glargine comparator arm, A1C began to increase after 52 weeks.

而在甘精胰島素比較組中，A1C 在 52 週後開始增加。

Durability of A1C control is a challenge for type 2 diabetes treatments.

A1C 控制的持久性是 2 型糖尿病治療的挑戰。

While the 104-week data isn't a definitive answer as to whether tirzepatide could potentially offer even longer-term durable blood glucose control, these data certainly are encouraging.

雖然 104 週的數據並不是關於 tirzepatide 是否可能提供更長期持久的血糖控制的明確答案，但這些數據無疑是令人鼓舞的。

Moving to Slide 15.

轉到幻燈片 15。

As you can see, weight loss plateaued at approximately 52 weeks and was maintained thereafter such that in 2 years, weight difference at the highest dose was approximately 15% compared to insulin glargine.

如您所見，體重減輕在大約 52 週時達到穩定水平，此後保持不變，因此在 2 年內，與甘精胰島素相比，最高劑量下的體重差異約為 15%。

We've seen in previous incretin therapy trials conducted with GLP-1s a further increased impact on weight reduction in participants with obesity without type 2 diabetes compared to studies in participants who do have type 2 diabetes such as this one.

我們在之前的 GLP-1 腸促胰島素治療試驗中看到，與對患有 2 型糖尿病的參與者的研究相比，沒有 2 型糖尿病的肥胖參與者對減輕體重的影響進一步增加。

It will be interesting to see if this trend also extends to the dual agonism of tirzepatide, which has demonstrated weight reductions in type 2 diabetes trials beyond what has been shown by GLP-1s to date.

有趣的是，這種趨勢是否也延伸到 tirzepatide 的雙重激動作用，它已在 2 型糖尿病試驗中證明體重減輕超過了迄今為止 GLP-1 所顯示的效果。

We clearly are excited about the weight loss potential here, and we believe the data to date bode well for upcoming readouts in obesity, starting with SURMOUNT-1, which reads out next year.

我們顯然對這裡的減肥潛力感到興奮，我們相信迄今為止的數據預示著即將到來的肥胖讀數，從明年開始的 SURMOUNT-1 開始。

Tirzepatide represents a new class of medicines, and we're focused on continuing our significant investment for patients with type 2 diabetes, obesity and related metabolic disorders who may benefit from tirzepatide.

Tirzepatide 代表了一類新的藥物，我們專注於繼續對可能受益於 tirzepatide 的 2 型糖尿病、肥胖症和相關代謝紊亂患者進行重大投資。

Moving to Slide 16.

轉到幻燈片 16。

Today, we announced the U.S. submission for tirzepatide in type 2 diabetes and that we used a Priority Review Voucher with the intention of bringing this investigational treatment to patients as quickly as possible.

今天，我們宣布了美國提交的用於 2 型糖尿病的 tirzepatide 的申請，並且我們使用了優先審查憑證，旨在盡快將這種研究性治療帶給患者。

We are delighted at the continued progress for this novel dual agonist, incretin, and hope to obtain approval in the U.S. by the middle of next year.

我們對這種新型雙重激動劑腸促胰島素的持續進展感到高興，並希望在明年年中之前在美國獲得批准。

Moving to donanemab.

轉移到多那麥布。

We have several important updates for this program.

我們對此程序有幾個重要的更新。

First, in the U.S., we initiated a rolling BLA submission to the FDA for accelerated approval in early Alzheimer's disease.

首先，在美國，我們開始向 FDA 提交滾動 BLA 申請，以加速早期阿爾茨海默病的批准。

We intend to complete the submission in the next few months and expect regulatory action in the second half of 2022.

我們打算在未來幾個月內完成提交，並預計在 2022 年下半年採取監管行動。

We've also completed the original planned enrollment of 1,500 participants for TRAILBLAZER-ALZ 2 and, based on the prespecified 18-month primary endpoint, expect to have top line results by the middle of 2023.

我們還完成了 TRAILBLAZER-ALZ 2 最初計劃的 1,500 名參與者的註冊，並且根據預先指定的 18 個月主要終點，預計到 2023 年中期將獲得一線結果。

We've added a separate single-arm addendum for safety exposures to TRAILBLAZER-ALZ 2, which has already enrolled more than 300 patients and is continuing to enroll rapidly.

我們為 TRAILBLAZER-ALZ 2 的安全暴露添加了單獨的單臂附錄，該附錄已經招募了 300 多名患者，並且正在繼續快速招募。

This addendum will provide us with additional safety data to support the rolling submission.

本附錄將為我們提供額外的安全數據以支持滾動提交。

Moving to TRAILBLAZER-ALZ 3. This is a prevention study for cognitively unimpaired individuals who already have Alzheimer's brain pathology but don't yet have clinical symptoms.

移至 TRAILBLAZER-ALZ 3。這是一項針對已經患有阿爾茨海默氏症腦部病變但尚未出現臨床症狀的認知未受損個體的預防研究。

We're excited to report that we have already initiated screening.

我們很高興地報告我們已經開始篩選。

This pioneering trial has multiple novel elements to reduce research subject burden, including the use of our phospho-tau217 blood assay currently in development to help detect Alzheimer's disease pathology in the patient screening process, video call technology for assessing cognitive function in the subject's home and a large network of infusion centers that allow subjects to select the site most convenient to them in a decentralized clinical trial paradigm.

這項開創性的試驗有多種新元素來減輕研究對象的負擔，包括使用我們目前正在開發的磷酸化 tau217 血液檢測來幫助檢測患者篩查過程中的阿爾茨海默病病理學、用於評估對象家中認知功能的視頻通話技術以及一個龐大的輸液中心網絡，允許受試者在分散的臨床試驗範式中選擇最方便的站點。

We also announced today our plans to conduct a head-to-head Phase III study comparing donanemab to aducanumab to assess superiority of brain amyloid plaque clearance in early symptomatic Alzheimer's disease.

我們今天還宣布了我們計劃進行一項頭對頭的 III 期研究，將 donanemab 與 aducanumab 進行比較，以評估腦澱粉樣蛋白斑塊清除在早期症狀性阿爾茨海默病中的優勢。

The co-primary endpoints will evaluate complete amyloid plaque clearance, as measured by Florbetapir F 18 PET scan, and will assess superiority on brain amyloid plaque clearance in the total population and also the intermediate tau subpopulation.

共同主要終點將評估通過 Florbetapir F 18 PET 掃描測量的完全澱粉樣蛋白斑塊清除，並將評估總人群和中間 tau 亞群中腦澱粉樣蛋白斑塊清除的優勢。

This study, TRAILBLAZER-ALZ 4, is expected to begin enrollment this year, and we expect to share primary endpoint data in the second half of 2022.

這項名為 TRAILBLAZER-ALZ 4 的研究預計將於今年開始招募，我們預計將在 2022 年下半年分享主要終點數據。

We're encouraged with the progress we've made with donanemab and with its potential to positively impact patients with high unmet medical need.

我們對 donanemab 取得的進展及其對醫療需求未得到滿足的患者產生積極影響的潛力感到鼓舞。

We have, of course, followed progress in the Alzheimer's disease landscape since our last call and are watching closely as CMS' National Coverage Determination process plays out.

當然，自上次電話會議以來，我們一直在關注阿爾茨海默病領域的進展，並密切關注 CMS 的全國覆蓋範圍確定過程。

We're committed to facing the challenges of effectively communicating donanemab's clinical data and value proposition and to ensuring that the diagnostic and patient management ecosystems are adequately well prepared.

我們致力於應對有效傳達 donanemab 的臨床數據和價值主張的挑戰，並確保為診斷和患者管理生態系統做好充分準備。

Given the current environment, we think it's reasonable to have modest expectations for the scale of patient impact for anti-amyloid therapies available under accelerated approval prior to the readout of their definitive Phase III data.

鑑於目前的環境，我們認為在讀取其最終 III 期數據之前，對加速批准下可用的抗澱粉樣蛋白療法的患者影響規模有適度的期望是合理的。

Assuming potential accelerated approval for donanemab in the second half of 2022, our expected TRAILBLAZER-ALZ 2 Phase III readout by mid-2023 would follow quickly, meaning the window of accelerated approval without definitive Phase III data is likely to be brief.

假設可能在 2022 年下半年加速批准 donanemab，我們預計到 2023 年中期的 TRAILBLAZER-ALZ 2 III 期讀數將很快跟進，這意味著沒有明確的 III 期數據的加速批准窗口可能很短暫。

Assuming positive Phase III results, we should be confident in the mid- and long-term opportunity for donanemab if approved.

假設 III 期結果是積極的，如果獲得批准，我們應該對 donanemab 的中長期機會充滿信心。

Moving on to Verzenio.

繼續前往 Verzenio。

In line with the expectations I outlined last quarter, we were pleased with Verzenio's recent FDA approval as the first and only CDK4/6 inhibitor in combination with endocrine therapy for adult patients with HR+, HER2-, node positive early breast cancer, who are at high risk of recurrence with a Ki-67 index of greater than or equal to 20%, as detected by an FDA-approved test.

與我在上個季度概述的預期一致，我們很高興 Verzenio 最近獲得 FDA 批准，作為第一個也是唯一一個 CDK4/6 抑製劑與內分泌治療聯合用於 HR+、HER2-、淋巴結陽性早期乳腺癌成人患者，他們在通過 FDA 批准的測試檢測到 Ki-67 指數大於或等於 20% 的高複發風險。

This approval in the adjuvant setting represents the first new addition to endocrine therapy in adjuvant treatment of HR+, HER2- breast cancer in nearly 2 decades.

這一輔助治療的批准代表了近 20 年來內分泌治療在 HR+、HER2- 乳腺癌輔助治療中的第一個新補充。

We are delighted to bring this important, new treatment option to patients.

我們很高興為患者帶來這一重要的新治療選擇。

Also, we recently shared updated data from the entire monarchE study at the ESMO Virtual Plenary meeting and copublished these data in the Annals of Oncology.

此外，我們最近在 ESMO 虛擬全體會議上分享了整個 monarchE 研究的更新數據，並在《腫瘤學年鑑》中共同發表了這些數據。

These data, which reflect additional follow-ups since our last public presentation, highlight the robustness of the effect size we're seeing for Verzenio in the adjuvant setting.

這些數據反映了自我們上次公開演講以來的額外後續行動，突出了我們在輔助環境中看到的 Verzenio 效應大小的穩健性。

Notably, with a median follow-up of 27 months, we were pleased to see both IDFS and DRFS benefit extend beyond the 2-year study treatment period.

值得注意的是，中位隨訪時間為 27 個月，我們很高興地看到 IDFS 和 DRFS 的益處都超過了 2 年的研究治療期。

These data are not only important for patients but also to help dispel concerns that the curves would come back together over time.

這些數據不僅對患者很重要，而且有助於消除人們對曲線會隨著時間的推移重新聚集在一起的擔憂。

We're clearly observing -- we've clearly observed continued separation of the curves, if not expanding separation.

我們清楚地觀察到——我們已經清楚地觀察到曲線的持續分離，如果不是擴大分離的話。

Since the adjuvant approval 2 weeks ago, there have been questions regarding why the FDA approval applied only to a subset of the study population.

自兩週前獲得輔助藥物批准以來，一直存在關於為什麼 FDA 批准僅適用於研究人群的一個子集的問題。

As previously communicated, overall survival was a secondary outcome measure for the monarchE study and an important component of the FDA's review.

如前所述，總體生存率是 monarchE 研究的次要結果指標，也是 FDA 審查的重要組成部分。

While we do not typically publish immature overall survival data, we feel it's valuable to address these important questions about the difference between the enrolled study population and the approved indication.

雖然我們通常不會發布不成熟的總體生存數據，但我們認為解決這些關於納入研究人群和批准適應症之間差異的重要問題是有價值的。

As a result, while the overall survival data remain immature, we do plan to publish the OS data from the additional follow-up analysis with cutoff of April 1, 2021, in a medical journal in the coming days.

因此，雖然總體生存數據仍然不成熟，但我們確實計劃在未來幾天在醫學期刊上公佈額外後續分析的 OS 數據，截止日期為 2021 年 4 月 1 日。

These data will show what we have observed thus far for overall survival trends in the ITT population compared to the approved population.

這些數據將顯示我們迄今為止觀察到的 ITT 人群與批准人群相比的總體生存趨勢。

We'll continue to follow patients in the ITT population for more mature overall survival data.

我們將繼續跟踪 ITT 人群中的患者，以獲得更成熟的總體生存數據。

If a positive OS trend emerges in the ITT population, we plan to work with regulators to expand our adjuvant indication.

如果 ITT 人群中出現積極的 OS 趨勢，我們計劃與監管機構合作擴大我們的輔助適應症。

Importantly, the collective results from Verzenio's clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and we look forward to continued investment in Verzenio for breast and prostate cancer and are excited about the opportunity to serve more patients.

重要的是， Verzenio 臨床開發計劃的集體結果證明了差異化的 CDK4/6抑製劑譜，我們期待繼續投資 Verzenio 治療乳腺癌和前列腺癌，並對有機會為更多患者服務感到興奮。

Slide 17 shows select pipeline opportunities as of October 22, and Slide 18 shows potential key events for the year.

幻燈片 17 顯示了截至 10 月 22 日的選定管道機會，幻燈片 18 顯示了今年潛在的關鍵事件。

There have been several important developments since our last earnings call, and I'll cover these by therapeutic area.

自我們上次召開財報電話會議以來，已經有了幾項重要的發展，我將按治療領域介紹這些發展。

In oncology, in addition to the exciting news for Verzenio, we continue our investment in pirtobrutinib's Phase III program with an additional study starting chronic lymphocytic leukemia, including fixed-duration pirtobrutinib plus venetoclax and rituximab in relapsed or refractory patients.

在腫瘤學方面，除了 Verzenio 令人振奮的消息外，我們繼續投資於 pirtobrutinib 的 III 期項目，並開展了一項啟動慢性淋巴細胞白血病的額外研究，包括在復發或難治性患者中的固定持續時間 pirtobrutinib 加維奈托克和利妥昔單抗。

We plan to start a study in first-line treatment compared to bendamustine plus rituximab before year-end.

我們計劃在年底前開始一項與苯達莫司汀加利妥昔單抗相比的一線治療研究。

We prioritized this first-line study rather than the head-to-head study evaluating superiority compared to ibrutinib as we think this first-line study could provide a faster pathway to bring pirtobrutinib to patients in the first-line setting.

我們優先考慮這項一線研究，而不是評估與依魯替尼相比優勢的頭對頭研究，因為我們認為這項一線研究可以提供一條更快的途徑，將匹托布替尼帶給一線患者。

We expect the head-to-head ibrutinib CLL study to start in the first half of 2022.

我們預計伊布替尼 CLL 頭對頭研究將於 2022 年上半年開始。

We look forward to sharing an updated dataset from the Phase I/II BRUIN study at a medical meeting later this year.

我們期待在今年晚些時候的醫學會議上分享來自 I/II 期 BRUIN 研究的更新數據集。

We plan to provide a regulatory update for pirtobrutinib at our Investor Day in December.

我們計劃在 12 月的投資者日提供 pirtobrutinib 的監管更新。

Imlunestrant, our oral SERD, also moved into Phase III with the start of its monotherapy study compared to exemestane or fulvestrant.

與依西美坦或氟維司群相比，我們的口服 SERD Imlunestrant 也進入了 III 期，開始進行單藥治療研究。

Finally, we also publicly identified and presented preclinical characterization for 2 new agents at the molecular targets meeting this month: LOXO-783, which is a highly mutant-selective allosteric PI3K alpha inhibitor; and LOXO-435, which is a highly isoform-selective FGFR3 inhibitor.

最後，我們還在本月的分子靶點會議上公開鑑定並展示了 2 種新藥物的臨床前表徵：LOXO-783，它是一種高度突變選擇性變構 PI3K α 抑製劑；和 LOXO-435，它是一種高度異構體選擇性 FGFR3 抑製劑。

We look forward to filing INDs for both programs in 2022 and subsequently moving them into the clinic.

我們期待在 2022 年為這兩個項目提交 IND，然後將它們轉移到臨床。

In diabetes, in addition to the tirzepatide update, we obtained U.S. approval for Jardiance and HFrEF, presented detailed results from the EMPEROR-Preserved study at the European Society of Cardiology and submitted for HFpEF in the U.S. and Europe.

在糖尿病方面，除了 tirzepatide 更新，我們還獲得了美國對 Jardiance 和 HFrEF 的批准，在歐洲心髒病學會提交了 EMPEROR-Preserved 研究的詳細結果，並在美國和歐洲提交了 HFpEF。

We're excited about the opportunity Jardiance has to improve outcomes for patients across type 2 diabetes, heart failure and chronic kidney disease.

我們對 Jardiance 有機會改善 2 型糖尿病、心力衰竭和慢性腎病患者的預後感到興奮。

We also started Phase II studies for our GLP-1 nonpeptide agonist in collaboration with Chugai in type 2 diabetes and in obesity and look forward to sharing some Phase I data from this molecule in December.

我們還與 Chugai 合作開始了 GLP-1 非肽激動劑的 II 期研究，用於 2 型糖尿病和肥胖症，並期待在 12 月分享該分子的一些 I 期數據。

In immunology, we were delighted to have multiple positive Phase III readouts for lebrikizumab in atopic dermatitis and look forward to the readout of the maintenance data from the ADvocate 1 and 2 studies in the first half of next year, ahead of global submissions expected by the end of 2022.

在免疫學方面，我們很高興獲得 lebrikizumab 在特應性皮炎中的多個陽性 III 期讀數，並期待在明年上半年公佈 ADvocate 1 和 2 研究的維持數據，在全球提交之前2022 年底。

We're pleased with our progress in immunology this year with positive Phase III readouts for mirikizumab and lebrikizumab and look forward to sharing more about our next generation of early-phase immunology assets in December.

我們對今年在免疫學方面取得的進展感到高興，mirikizumab 和 lebrikizumab 的 III 期讀數呈陽性，並期待在 12 月分享更多關於我們下一代早期免疫學資產的信息。

In neurodegeneration, our anti-tau antibody, zagotenemab, recently concluded its Phase II study in early symptomatic Alzheimer's.

在神經退行性變方面，我們的抗 tau 抗體 zagotenemab 最近結束了其在早期症狀性阿爾茨海默病中的 II 期研究。

Zagotenemab failed to meet the primary endpoint and was unable to modulate tau's spread in the brain.

Zagotenemab 未能達到主要終點，也無法調節 tau 在大腦中的擴散。

The placebo population progressed as expected.

安慰劑人群按預期進展。

While this negative outcome was disappointing and we're discontinuing development for zagotenemab, we remain committed to tau as a high-conviction target in Alzheimer's disease and plan to continue studying tau biology, including inhibition of tau aggregation with a small-molecule OGA inhibitor currently in the clinic.

雖然這一負面結果令人失望，我們正在停止 zagotenemab 的開發，但我們仍然致力於將 tau 作為阿爾茨海默病的高度確信的靶點，併計劃繼續研究 tau 生物學，包括目前使用小分子 OGA 抑製劑抑制 tau 聚集在診所。

In the pain therapeutic area, in collaboration with Pfizer, we discontinued the global clinical development program for tanezumab following receipt of a Complete Response Letter from the FDA for tanezumab in osteoarthritis pain and a negative opinion adopted by the CHMP.

在疼痛治療領域，我們與輝瑞（Pfizer）合作，在收到 FDA 對 tanezumab 治療骨關節炎疼痛的完整回應信和 CHMP 採納的負面意見後，終止了 tanezumab 的全球臨床開發計劃。

And finally, the FDA expanded the Emergency Use Authorization for bamlanivimab and etesevimab administered together to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection.

最後，FDA 擴大了 bamlanivimab 和 etesevimab 的緊急使用授權，以包括某些個體的暴露後預防，以預防 SARS-CoV-2 感染。

To recap, Q3 was another positive quarter for R&D at Lilly, continuing the positive momentum we've seen with a steady stream of significant pipeline advancements over the last couple of years as we move closer towards our goal of delivering more first or best-in-class treatment options to patients in areas of unmet need.

回顧一下，第三季度是禮來（Lilly）研發的又一個積極的季度，延續了我們在過去幾年中看到的積極勢頭，隨著我們朝著交付更多首創或最佳產品的目標邁進為未滿足需求領域的患者提供一流的治療選擇。

Now I'll turn the call back to Dave for some closing remarks.

現在，我將把電話轉回戴夫，以發表一些結束語。

Okay.

好的。

Thanks, Dan.

謝謝，丹。

Before we go to Q&A, let me sum up the progress we've made during the quarter.

在進行問答之前，讓我總結一下我們在本季度取得的進展。

We have seen continued strength in our core business through the first 9 months of the year with double-digit, volume-driven revenue growth, net of COVID-19 therapies, and strong performance across key brands.

今年前 9 個月，我們的核心業務持續強勁，銷售額實現兩位數增長，扣除 COVID-19 療法後，關鍵品牌表現強勁。

We're pleased to see sequential and year-over-year operating margin expansion as well as strong non-GAAP earnings growth.

我們很高興看到營業利潤率的連續和同比增長以及強勁的非公認會計準則收益增長。

We have made significant progress developing new medicines, and Q3 was another important quarter for our pipeline as we announced the submission of tirzepatide in type 2 diabetes, the initiation of a rolling submission for donanemab in the U.S. for early Alzheimer's disease, key life cycle approvals, and submissions for Verzenio and Jardiance and positive Phase III readouts for lebrikizumab.

我們在開發新藥方面取得了重大進展，第三季度是我們管道的另一個重要季度，因為我們宣布提交用於 2 型糖尿病的 tirzepatide，開始在美國滾動提交用於治療早期阿爾茨海默病的 donanemab，關鍵生命週期批准，並提交 Verzenio 和 Jardiance 以及 lebrikizumab 的積極 III 期讀數。

We returned nearly $800 million to shareholders through dividends in Q3, reflecting confidence in the ongoing strength of our business.

我們在第三季度通過股息向股東返還了近 8 億美元，反映了對我們業務持續實力的信心。

As we move toward the close of 2021, we are confident in our long-term growth prospects.

隨著我們邁向 2021 年底，我們對我們的長期增長前景充滿信心。

While the past year has seen tremendous advances in our late-stage pipeline, at our Investor Day in December, we look forward to sharing information with you regarding the next generation of assets that we believe will enable us to sustain the flow of innovative medicines to patients and augment our future growth prospects.

儘管過去一年我們的後期管道取得了巨大進展，但在 12 月的投資者日，我們期待與您分享有關下一代資產的信息，我們相信這些資產將使我們能夠維持創新藥物的流動，患者並擴大我們未來的增長前景。

Now I'll turn the call over to Kevin to moderate the Q&A session.

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

（操作員說明）Lois，請提供問答環節的說明，然後我們為第一個來電者做好準備。

(Operator Instructions) And our first question is from the line of Chris Schott.

（操作員說明）我們的第一個問題來自 Chris Schott。

I guess the first one from me is just on some of the 2022 comments.

我想我的第一個評論只是在 2022 年的一些評論中。

I know you're not giving formal guidance yet.

我知道你還沒有給出正式的指導。

But should we be thinking about margin expansion next year from the, I guess, roughly 30%-or-so margins that are implied in this year's guidance?

但我們是否應該考慮明年的利潤率擴張，我猜，今年的指導中暗示的利潤率約為 30% 左右？

I'm just trying to get my hands around how meaningful of a step-up in OpEx we should be thinking about supporting these major new launches coming next year.

我只是想弄清楚我們應該考慮支持明年即將推出的這些重大新產品的運營支出提升有多大意義。

And the second one was just one related to BIIB's rollout of Aduhelm.

第二個只是與 BIIB 推出 Aduhelm 相關的一個。

It's obviously been a challenging launch.

這顯然是一個具有挑戰性的發布。

Are there learnings here or just changes about how you're thinking about your go-to-market strategy for donanemab?

這裡是否有學習或只是改變了您對 donanemab 上市策略的思考方式？

And I know, Dan, you made some of those comments in the remarks, but should we be thinking about much in the way of revenue at all for donanemab and, I guess, in that window between when it's approved and prior to TRAILBLAZER-2?

我知道，丹，你在評論中發表了一些評論，但我們是否應該考慮多納奈馬的收入方式，我想，在它被批准和 TRAILBLAZER-2 之前的那個窗口中?

I'm just trying to get a sense of, again, just as you look at what's happened there, has there been surprises or changes in your thinking on the market?

我只是想再次了解一下，當您查看那裡發生的事情時，您對市場的看法是否發生了意外或變化？

Thanks, Chris.

謝謝，克里斯。

We'll go to Anat for the first question on 2022 margin expansion and then to Anne on thoughts about the uptake and outlook for donanemab.

我們將向 Anat 詢問關於 2022 年利潤率擴張的第一個問題，然後向 Anne 詢問關於 donanemab 的吸收和前景的想法。

Great.

偉大的。

Thanks.

謝謝。

So for 2022, we will provide further details and guidance in a -- in December, so not too far from now, and we'll provide additional clarity on how we view the year and what investments and pushes and pulls we have going into next year.

因此，對於 2022 年，我們將在距離現在不遠的 12 月提供更多詳細信息和指導，我們將進一步明確我們如何看待這一年以及我們接下來將進行哪些投資和推動和拉動年。

As you think about our margin expansion and the goals we've set out and we've communicated in terms of getting to mid- to high 30s in terms of margin expansion, we still have a clear line of sight to get there, and that's still our goal.

當您考慮我們的利潤率擴張和我們設定的目標時，我們已經就利潤率擴張達到 30 多歲的中高水平進行了溝通，我們仍然有明確的目標，那就是仍然是我們的目標。

They'll be -- but it's not a linear growth.

他們會——但這不是線性增長。

So there'll be years there are going to be -- stronger years where we're going to be making specific targeted investments.

因此，將會有幾年 - 更強勁的年份，我們將進行特定的有針對性的投資。

And as you've seen us do this year with donanemab, when we have strong convictions in a pipeline asset or when we're preparing to launch very promising opportunities and products, we will invest behind them.

正如你在今年看到我們對多納麥布所做的那樣，當我們對管道資產有堅定的信念，或者當我們準備推出非常有前途的機會和產品時，我們將在它們背後進行投資。

So think about this as still growing to mid- to high 30s but not necessarily in a linear fashion but in line with investments we would need to make.

因此，請考慮將其視為仍在增長到 30 多歲的中高水平，但不一定以線性方式，而是符合我們需要進行的投資。

Thanks, Anat.

謝謝，阿納特。

Anne?

安妮？

Well, as Dan stated and as our competitor has shared their experience, there clearly is work to do to ensure that the diagnostic and the patient ecosystems are prepared for these medicines.

好吧，正如丹所說，正如我們的競爭對手分享了他們的經驗，顯然還有工作要做，以確保為這些藥物準備好診斷和患者生態系統。

And until there is definitive Phase III data, we do believe that we should really expect modest use of these medicines.

在獲得明確的 III 期數據之前，我們確實相信我們應該真正期望適度使用這些藥物。

Now fortunately, as Dan said, for donanemab, this confirmatory data comes quickly in mid-'23 for TRAILBLAZER-ALZ 2. And so this will be the opportunity to really help patients on a more significant scale.

現在幸運的是，正如 Dan 所說，對於 donanemab，對於 TRAILBLAZER-ALZ 2，這一驗證性數據在 23 年中期很快就出現了。因此，這將是真正幫助更大範圍內的患者的機會。

Now some of the opportunities here.

現在這裡有一些機會。

Certainly, pursuing accelerated approval is really important both to provide early access but also to let us begin addressing some of these infrastructure challenges ahead of the Phase III data.

當然，追求加速批准對於提供早期訪問以及讓我們在第三階段數據之前開始解決其中一些基礎設施挑戰非常重要。

We need to build out the diagnostic ecosystem, particularly PET scans and blood tests.

我們需要建立診斷生態系統，特別是 PET 掃描和血液檢測。

We need to make sure that there's adequate infusion capacity.

我們需要確保有足夠的輸液能力。

And then very importantly, we need to ensure that there's reimbursements so that the appropriate patients can have access to donanemab.

然後非常重要的是，我們需要確保有報銷，以便適當的患者可以使用多那奈單抗。

So these are going to be our areas of focus now through our Phase III window.

因此，這些將成為我們現在通過第三階段窗口關注的領域。

We're confident in our ability to address these infrastructure challenges over time.

隨著時間的推移，我們對解決這些基礎設施挑戰的能力充滿信心。

And I would say by clearing plaque faster and deeper, we believe that as well as identifying the right patients, we've optimized the chances for showing compelling benefits in the Phase III, which, as we've said, is what was going to show significant uptake in the class.

我想說的是，通過更快、更深入地清除牙菌斑，我們相信，除了確定合適的患者外，我們還優化了在 III 期臨床試驗中顯示令人信服的益處的機會，正如我們所說，這將是在課堂上表現出顯著的吸收。

We continue to see the same opportunity for donanemab in the mid to long term once these challenges are addressed and the confirmatory data is available.

一旦解決了這些挑戰並獲得了確認數據，我們將繼續看到多拿尼單抗在中長期內同樣的機會。

Thanks, Anne.

謝謝，安妮。

Chris, thanks for your questions.

克里斯，謝謝你的提問。

The next caller is Geoff Meacham from Bank of America.

下一位來電者是美國銀行的 Geoff Meacham。

I had 2 on Alzheimer's probably for Dan.

我有 2 條阿爾茨海默氏症可能是為了丹。

For donanemab, would you expect completion of the rolling submission by the end of this year?

對於 donanemab，您希望在今年年底前完成滾動提交嗎？

And is there a regulatory threshold you need to hit in terms of the safety exposure?

就安全風險而言，您是否需要達到監管門檻？

I'm just trying to think of the number of patients that you have to get exposed to.

我只是想想想你必須接觸的病人數量。

And then for zagotenemab, what are the next steps here?

然後對於 zagotenemab，接下來的步驟是什麼？

Is it moving to another anti-tau asset altogether?

它會完全轉移到另一個反 tau 資產嗎？

Or do you want to optimize monotherapy zagotenemab or maybe even move forward in combination with donanemab?

或者您是否想優化單藥扎戈替尼，或者甚至與多納奈馬聯合使用？

Thanks, Geoff.

謝謝，傑夫。

Dan?

擔？

Great.

偉大的。

Thanks, Geoff, for 2 good questions.

謝謝，傑夫，提出兩個好問題。

The first is just on the timing of the completion of the donanemab rolling submission.

第一個只是關於完成donanemab滾動提交的時間。

I think you can assume we chose our words carefully here in the call prepared remarks on the timing.

我想你可以假設我們在電話會議上仔細選擇了我們的措辭，準備好了關於時間的評論。

You're sort of driving at like what's the regulatory hurdle with respect to safety exposures.

你有點像在安全風險方面的監管障礙。

You're right, that's the key gating factor on timing.

你是對的，這是時間的關鍵門控因素。

You've heard we've enrolled a lot of patients in the clinical trials, including patients in a safety addendum.

你聽說我們在臨床試驗中招募了很多患者，包括安全附錄中的患者。

So we're extremely confident we'll reach that safety exposure hurdle.

因此，我們非常有信心能夠達到安全暴露的障礙。

I guess looking forward, there's probably 2 risks or question marks.

我想展望未來，可能有 2 個風險或問號。

One is just around the timing of exactly when do databases get locked in and data get cleaned and submitted to the FDA.

一個是數據庫被鎖定、數據被清理並提交給 FDA 的確切時間。

So that's why we're a little vague on timing here.

所以這就是為什麼我們在這裡的時間有點模糊。

I think the second one, of course, that we don't know and won't know until all that data is in is what is the safety data actually show.

我認為第二個，當然，我們不知道也不會知道，直到所有數據都包含在安全數據實際顯示的內容中。

And so the assumption here, of course, is that they continue to be consistent with what we've seen in Phase II.

因此，當然，這裡的假設是它們繼續與我們在第二階段看到的一致。

So if those things work out, then I think that will be the opportunity to talk a little more specifically about the data.

因此，如果這些事情成功了，那麼我認為這將是一個更具體地談論數據的機會。

With respect to zagotenemab, look, I think we have here a very potent anti-tau antibody designed against what we believe is an important species of aggregated tau delivered at relatively high doses for any monoclonal antibody, and we were unable to slow the spread of tau progression in the brain.

關於 zagotenemab，看，我認為我們這裡有一種非常有效的抗 tau 抗體，設計用於對抗我們認為對於任何單克隆抗體以相對高劑量遞送的重要聚集 tau 物種，我們無法減緩tau 在大腦中的進展。

So at present, I don't see a path forward for this antibody, and I would be reluctant to invest in really any anti-tau antibody given what we've seen here.

所以目前，我看不到這種抗體的前進道路，鑑於我們在這裡看到的情況，我不願意投資任何抗 tau 抗體。

Tau is still a great target.

Tau 仍然是一個很好的目標。

It's just hard to hit it with a monoclonal antibody, I think, given that most of the tau that we care about is inside of cells.

考慮到我們關心的大部分 tau 蛋白都在細胞內，我認為用單克隆抗體很難擊中它。

Thanks, Dan.

謝謝，丹。

Geoff, thanks for your questions.

傑夫，謝謝你的提問。

And the next caller is Louise Chen from Cantor.

下一位來電者是來自 Cantor 的 Louise Chen。

So my first question is, how are you preparing for the launch of donanemab and tirzepatide next year?

所以我的第一個問題是，你們準備如何在明年推出多那奈單抗和替西帕肽？

And how should we think about the costs associated with that launch?

我們應該如何考慮與該發射相關的成本？

And then second question I had for you is, do you think it's the National Coverage Determination or the price of Aduhelm that is keeping doctors on the sidelines?

然後我要問你的第二個問題是，你認為是國家覆蓋範圍決定還是 Aduhelm 的價格讓醫生處於觀望狀態？

Thanks.

謝謝。

We'll go to Anat for the question on just launch prep and the overall cost for both tirzepatide and donanemab, how we think about that going into next year.

我們將向 Anat 詢問有關啟動準備的問題以及 tirzepatide 和 donanemab 的總體成本，以及我們如何看待明年的問題。

And then we'll go to Anne for the question around the NCD and Aduhelm.

然後我們將向 Anne 詢問有關 NCD 和 Aduhelm 的問題。

Sure.

當然。

So as we're preparing to launch both these medicines, obviously one is in an area where we have significant commercial footprint, manufacturing scale-up capabilities.

因此，當我們準備推出這兩種藥物時，顯然其中一種是在我們擁有重要商業足跡和製造規模擴大能力的領域。

And the other one is an area we're currently building.

另一個是我們目前正在建設的區域。

So we're investing in advancing both of these efforts forward, preparing for a potential launch of tirzepatide mid-next year and then a regulatory decision on donanemab at the second half of next year.

因此，我們正在投資推進這兩項工作，為明年年中可能推出的 tirzepatide 以及明年下半年對多納奈馬的監管決定做準備。

Those will be factored into the guidance that we will provide on December 15 as we go into next year.

這些將被納入我們將於明年 12 月 15 日提供的指導中。

But rest assured we're building the commercial footprint that we needed to launch these effectively and leveraging the existing footprint we have as well.

但請放心，我們正在建立有效啟動這些產品所需的商業足跡，並利用我們現有的足跡。

Thanks, Anat.

謝謝，阿納特。

Anne?

安妮？

Well, it's a good question that you've asked, and I do think there's a number of things that are a challenge here.

嗯，你問的問題很好，我確實認為這裡有很多挑戰。

I think as you look at donanemab, what's incredibly important is that we had a positive Phase II study that clearly met its primary endpoint, showing cognitive benefits for donanemab.

我認為當您查看 donanemab 時，非常重要的是我們進行了一項積極的 II 期研究，該研究清楚地達到了其主要終點，顯示了 donanemab 的認知益處。

As well, we were able to share that we had limited-duration dosing to plaque clearance.

同樣，我們能夠分享我們對斑塊清除的持續時間有限。

And so we believe that this is going to be important for the decisions that physicians and payers make.

因此，我們相信這對於醫生和付款人做出的決定非常重要。

So I believe that the donanemab data is incredibly strong, and then, as I said, following quickly the Phase III confirmatory data, which I think is important.

因此，我相信 donanemab 的數據非常強大，然後，正如我所說，快速跟進 III 期驗證數據，我認為這很重要。

And all of this published in the New England Journal of Medicine.

所有這些都發表在《新英格蘭醫學雜誌》上。

So as we're talking to thought leaders and physicians, I do believe that they see the strength of the data that we brought forward in donanemab.

因此，當我們與思想領袖和醫生交談時，我相信他們看到了我們在 donanemab 中提出的數據的力量。

And I think that's been a challenge that they've had with some of the competitive space.

我認為這是他們在一些競爭空間中遇到的挑戰。

So I do think that data is one thing on their minds.

所以我確實認為數據是他們心中的一件事。

I think as well, the NCD is playing a role.

我也認為，非傳染性疾病正在發揮作用。

Obviously, that will be resolved before we launch.

顯然，這將在我們發布之前解決。

And we'll be ready for any of the potential outcomes there and have been working closely with them along the way to make sure that they understand the donanemab data, particularly the rapid clearing of plaques as well as the limited-duration dosing that offers, we think, benefit to them as well.

我們將為那裡的任何潛在結果做好準備，並一直與他們密切合作，以確保他們了解 donanemab 數據，特別是斑塊的快速清除以及提供的限時給藥，我們認為，對他們也有好處。

So it's been a good conversation with them so far.

所以到目前為止，與他們的對話非常愉快。

We really look forward to seeing what they have to say -- CMS has to say in January, and then launching with this strong dataset, as Dan said, in the second half of next year.

我們真的很期待看到他們要說什麼——CMS 必須在一月份說，然後像 Dan 所說的那樣在明年下半年推出這個強大的數據集。

Thanks, Anne.

謝謝，安妮。

Louise, thanks for your question.

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 couple of questions on the pending NCD by CMS.

我對 CMS 的未決 NCD 有幾個問題。

So 2 questions.

所以2個問題。

First, it's commonly said that this upcoming decision will pertain to the whole ADA class.

首先，通常說這個即將到來的決定將涉及整個 ADA 類。

I struggle to see how that can realistically be the case because that decision will be made on only one company's mixed Phase III data, and there are still other really important informative Phase III datasets that are on the come.

我很難看到實際情況如何，因為該決定將僅根據一家公司的混合 III 期數據做出，並且還有其他非常重要的信息性 III 期數據集即將推出。

So wouldn't the NCD, whatever it is initially, potentially be revised later and CMS has more information from these additional trials?

那麼 NCD 會不會，不管它最初是什麼，可能會在以後進行修訂，並且 CMS 從這些額外的試驗中獲得更多信息？

And then second, if this is indeed a decision that pertains to the whole class, then presumably Lilly has a view on what will happen in January.

其次，如果這確實是一個涉及整個班級的決定，那麼 Lilly 大概對一月份會發生什麼有看法。

So do you expect CMS will say that Aduhelm and the class more broadly should be covered in a way that will be commercially meaningful?

那麼您是否期望 CMS 會說 Aduhelm 和更廣泛的課程應該以具有商業意義的方式進行覆蓋？

One can envision that there could be lots of restrictions that might, in fact, limit the commercial market opportunity.

可以設想，可能存在許多實際上可能限製商業市場機會的限制。

Thanks, Tim.

謝謝，蒂姆。

We'll go to Anne for those questions on the NCD process.

我們將向 Anne 詢問有關 NCD 流程的問題。

Well, thanks.

非常感謝。

Good questions on the process with the NCD.

關於 NCD 流程的好問題。

So CMS has been clear that the NCD, as they're running the process, is to cover the class.

因此 CMS 很清楚 NCD 在他們運行該過程時是為了覆蓋課程。

Now as I said, we are actively participating in the process, including we provided oral comments in July and additional written comments in August.

現在正如我所說，我們正在積極參與該過程，包括我們在 7 月提供了口頭意見，並在 8 月提供了額外的書面意見。

And we, and I'm sure others as well, have been meeting with CMS throughout the process to share our specific data and ensure that the differences in these medicines are understood.

我們，我相信其他人也在整個過程中與 CMS 會面，分享我們的具體數據，並確保了解這些藥物的差異。

And so we've asked them really to evaluate each drug based on their own data.

所以我們要求他們根據自己的數據評估每種藥物。

And this is, I think, as I said, particularly important considering that there are some differences between these.

我認為，正如我所說，考慮到它們之間存在一些差異，這一點尤其重要。

We shared the data later in the year subsequent to the original readout that the degree of donanemab plaque clearance relates to clinical benefit, which I know is very important to CMS in this decision, as well as the limited-duration dosing.

在最初公佈多納奈單抗斑塊清除程度與臨床益處相關的數據後，我們在當年晚些時候分享了數據，我知道這對 CMS 的這一決定以及有限持續時間的給藥非常重要。

So we really look forward to seeing what they have to say in January and what that readout will look like.

所以我們真的很期待看到他們在一月份要說什麼，以及讀數會是什麼樣子。

We do acknowledge there's a lot of skepticism in the national discussion.

我們確實承認在全國討論中存在很多懷疑。

And so we do really hope and we're -- will continue to influence that we think each drug should be evaluated by CMS, by payers and prescribers on their own data.

因此，我們確實希望並且我們將繼續影響我們認為每種藥物都應該由 CMS、付款人和開處方者根據他們自己的數據進行評估。

It is possible that the NCD will narrow for the patients most likely to benefit.

對於最有可能受益的患者，非傳染性疾病可能會縮小。

That's a possibility out of this.

這是一種可能性。

But that's really aligned with the goals that we've had in our clinical trial designs, which has long been to use the diagnostic tools to make sure that the right patients are getting treatment.

但這確實與我們在臨床試驗設計中的目標一致，長期以來，我們一直使用診斷工具來確保正確的患者得到治療。

So we'll look forward to the readout in January.

因此，我們將期待一月份的讀數。

We'll continue to stay very engaged in this.

我們將繼續保持高度參與。

And yes, I believe as additional data comes out, our data and others in the class, that those will continue to influence the process.

是的，我相信隨著更多數據的出現，我們的數據和課堂上的其他人，這些將繼續影響這個過程。

Thanks, Anne.

謝謝，安妮。

Tim, thanks for your questions.

蒂姆，謝謝你的提問。

The next question comes from Andrew Baum from Citi.

下一個問題來自花旗的 Andrew Baum。

The noise coming out of Washington suggests that the Peters' bill, some of the components of that, are gaining traction and some of the more worrying component of price negotiations seem to be more and more limited.

來自華盛頓的噪音表明，彼得斯的法案，其中的一些組成部分，正在獲得牽引力，而價格談判中一些更令人擔憂的部分似乎越來越有限。

I just wonder if you could share any thoughts on what you think, just take the Peters' proposal on out-of-pocket caps, could mean to Lilly and the pharma in terms of increased volume without catastrophic coverage changes.

我只是想知道您是否可以就您的想法分享任何想法，只需接受 Peters 關於自付費用上限的提議，這對禮來和製藥公司來說可能意味著在不發生災難性覆蓋變化的情況下增加產量。

And then second, could you comment on whether you're seeing neutralization of donanemab by the antibody -- drug antibodies that you see with prolonged usage?

其次，您能否評論一下您是否看到抗體對多那單抗的中和作用——您在長期使用時看到的藥物抗體？

And is this one of the factors which is contributing to the finite treatment duration?

這是導致治療時間有限的因素之一嗎？

Or is neutralization simply not a concern here?

或者中和在這裡根本不是問題？

Thanks, Andrew.

謝謝，安德魯。

We'll go to Dave for the first question and Dan for the second.

第一個問題我們去找戴夫，第二個問題找丹。

Yes.

是的。

Thanks, Andrew, for the question.

謝謝，安德魯，這個問題。

Obviously, there's a lot of talking and discussing going on in Washington about how to make medicines more affordable.

顯然，華盛頓有很多關於如何使藥品更便宜的討論和討論。

I think we've been pretty consistent in our view that both as Lilly, and I can -- I think I can speak for the industry here, we are for progress.

我認為我們的觀點非常一致，禮來公司和我都可以——我想我可以在這里為這個行業說話，我們是為了進步。

We are not for the status quo.

我們不是為了現狀。

And the centerpiece of almost every part of legislation being discussed, which is, I think, good news for seniors, is some reform to the Part D benefit.

幾乎所有正在討論的立法部分的核心，我認為這對老年人來說是個好消息，是對 D 部分福利的一些改革。

That is certainly highlighted in representative Peters' bill.

這在代表彼得斯的法案中肯定得到了強調。

It's in H.R. 19.

這是在人力資源 19 中。

It was in the Grassley-Wyden effort.

這是在格拉斯利-懷登的努力下。

It's, I'm sure, in the Senate Finance effort now.

我敢肯定，它現在在參議院財政工作中。

And I think that's good news.

我認為這是個好消息。

The contours of that are all kind of different.

它的輪廓都是不同的。

But the general idea is that the industry would pay additional costs into the system, that, that would reduce monthly out-of-pocket costs, both below and above the catastrophic phase, cap catastrophic costs as well as eliminate the donut hole.

但總體思路是，該行業將向系統支付額外成本，這將減少災難性階段以下和以上的每月自付費用，限制災難性成本並消除甜甜圈洞。

I think we're basically for all those things, and we think that's a good set of initiatives.

我認為我們基本上支持所有這些事情，我們認為這是一套很好的舉措。

Where the debate sort of kicks in is around how to pay for that or whether pay-fors -- from the industry should go to other health care priorities.

爭論的焦點是如何為此支付費用或是否支付費用——來自該行業的是否應該用於其他醫療保健優先事項。

And of course, we have clear positions on that.

當然，我們對此有明確的立場。

One piece of Peters' bill we don't like is the retroactive CPI cap.

我們不喜歡彼得斯的一項法案是追溯 CPI 上限。

I think that's punitive and unfair.

我認為這是懲罰性和不公平的。

It also is disproportionate on some types of medicines versus others.

某些類型的藥物與其他藥物不成比例。

So I think the industry is aligned.

所以我認為這個行業是一致的。

We don't care for that.

我們不在乎那個。

Although in general, the idea of a CPI regulator on forward price increases is something people have gotten used to talking about.

儘管總的來說，人們已經習慣於談論關於遠期價格上漲的 CPI 監管機構的想法。

And then the thing we do put our foot down and firmly oppose and why we're so against HR 3 and other efforts is taking money out of the pharmaceutical industry for other priorities.

然後我們所做的事情是堅決反對並堅決反對，以及為什麼我們如此反對 HR 3 和其他努力，就是從製藥行業拿錢用於其他優先事項。

Isn't drug pricing a big enough problem?

藥品定價問題還不夠大嗎？

Why don't we take the money out of the pharmaceutical industry and give it to patients who want to buy our medicines?

為什麼我們不把醫藥行業的錢拿出來給那些想買我們藥品的病人呢？

And that's a position we've had for a long time.

這是我們長期以來的立場。

I think it's going to be a busy week, into next week probably negotiating out this package, but we're hopeful that some of these messages are resonating and we could land with a Part D reform and modest impact on the industry so we can keep innovating for the future.

我認為這將是忙碌的一周，可能會在下週就這一方案進行談判，但我們希望其中一些信息能引起共鳴，我們可以通過 D 部分改革並對行業產生適度影響，這樣我們就可以保持為未來而創新。

Thanks, Dave.

謝謝，戴夫。

Dan?

擔？

Yes, thanks, Andrew, for the question on antidrug antibodies or ADAs.

是的，謝謝安德魯，關於抗藥抗體或 ADA 的問題。

We do see ADAs with donanemab.

我們確實看到了帶有 donanemab 的 ADA。

They arise pretty early in treatment.

它們在治療的早期就出現了。

There is no connection, though, with ADAs and our decision on fixed-duration dosing.

但是，與 ADA 和我們對固定持續時間給藥的決定沒有任何联系。

The reason for that is because the doses that we're using are so much higher than the level of antidrug antibodies that we don't see an effect in our clinical trials at these doses of the ADAs on PK or, importantly, on PD, which is the plaque clearance effect of donanemab.

原因是因為我們使用的劑量遠遠高於抗藥物抗體的水平，以至於我們在臨床試驗中沒有看到這些劑量的 ADA 對 PK 或重要的是對 PD 的影響，這就是donanemab的斑塊清除作用。

So no connection there.

所以那裡沒有聯繫。

Thanks, Dan.

謝謝，丹。

Andrew, thanks for your question.

安德魯，謝謝你的提問。

The next caller is Seamus Fernandez from Guggenheim Securities.

下一位來電者是古根海姆證券公司的 Seamus Fernandez。

So maybe first on the performance of Verzenio in the quarter and then your conviction that this market can accelerate moving forward now with the Ki-67 approval.

所以也許首先是 Verzenio 在本季度的表現，然後你相信這個市場現在可以隨著 Ki-67 的批准加速向前發展。

We're hearing good things from physicians, but it just doesn't seem to be reflected in the opportunity that I think we all see ahead for Verzenio.

我們從醫生那裡聽到了好消息，但這似乎並沒有反映在我認為我們都預見到 Verzenio 的機會中。

And then as a separate question, I'm sure Mike Mason is tracking the opportunity in obesity very closely.

然後作為一個單獨的問題，我確信邁克梅森非常密切地跟踪肥胖的機會。

Just wondering what feedback is on the types of patients that are going on to Wegovy at this point and how Lilly is thinking about the opportunity in obesity given the attempted acceleration of the launch of tirzepatide with the PRV (Priority Review Voucher).

只是想知道在這一點上對 Wegovy 的患者類型有什麼反饋，以及禮來公司如何考慮肥胖的機會，因為它試圖通過 PRV（優先審查憑證）加速推出 tirzepatide。

And obviously, that's in diabetes but just wondering when we might see a full launch in obesity given all the trials.

顯然，這是在糖尿病中，但只是想知道考慮到所有試驗，我們何時會看到肥胖症的全面啟動。

Thanks, Seamus.

謝謝，西莫。

We'll go to Jake for the question on Verzenio and then Mike for the question on tirzepatide.

我們將向 Jake 詢問有關 Verzenio 的問題，然後向 Mike 詢問有關 tirzepatide 的問題。

Thanks, Seamus.

謝謝，西莫。

So just starting with Verzenio's performance in the quarter.

因此，從 Verzenio 在本季度的表現開始。

As you probably remember, we had some stocking that happened in the channel in second quarter.

您可能還記得，我們在第二季度的渠道中有一些庫存。

And so part of what happened this quarter is just a modest work-down of that inventory.

因此，本季度發生的部分情況只是對該庫存的適度縮減。

I think the fundamentals of where we stand in the metastatic setting continue to look really strong.

我認為我們在轉移性環境中所處的基本面仍然看起來非常強大。

I like where we are in terms of NBRx share hovering around 30%.

我喜歡我們的 NBRx 份額徘徊在 30% 左右。

Hopefully, we can continue to grow that.

希望我們可以繼續發展。

I think that we still haven't seen the entire class of CDK4/6 inhibitors return to pre-COVID levels of prescriptions.

我認為我們仍然沒有看到整個 CDK4/6 抑製劑類別恢復到 COVID 之前的處方水平。

And so that's an -- obviously an important lever for growth going forward, probably levered to things like mammogram volumes and other types of preventative care measures that get patients diagnosed and into doctors' offices.

因此，這顯然是推動未來增長的重要槓桿，可能用於諸如乳房 X 光檢查量和其他類型的預防性護理措施，這些措施可以讓患者得到診斷並進入醫生辦公室。

But we continue to grow our share of NBRx, within the market.

但我們繼續在市場中增加我們在 NBRx 中的份額。

Turning to adjuvant.

轉向輔助。

Obviously, we're very excited about launching this medicine for men and women with early breast cancer, specifically Ki-67 high patients.

顯然，我們很高興為患有早期乳腺癌的男性和女性推出這種藥物，特別是 Ki-67 高患者。

It's a real opportunity.

這是一個真正的機會。

As I think you've probably heard us say before, it's about 8,000 to 10,000 patients.

我想你可能聽過我們之前說過，大約有 8,000 到 10,000 名患者。

It's obviously a smaller opportunity than the entire study population that we enrolled in monarchE.

這顯然比我們在 monarchE 註冊的整個研究人群的機會更小。

And as you know, we'll be looking -- again, next year will be the next analysis of survival to potentially expand to that broader population should OS trend in the direction that we and FDA want to see to do that.

如你所知，我們將再次關注——如果 OS 朝著我們和 FDA 希望看到的方向發展，明年將是下一個可能擴展到更廣泛人群的生存分析。

But we have a great opportunity ahead of us.

但我們面前有一個很好的機會。

I think certainly, it's growth from where we stand today.

我認為當然，這是從我們今天的立場開始的增長。

It's a brand-new indication of real size in terms of both patient numbers and duration.

就患者人數和持續時間而言，這是一個全新的真實規模指標。

In many ways, that -- realizing that is also linked to the prior comments I made about patients returning to the doctor for preventative care to get diagnosed at levels hopefully that return to pre-COVID, and we don't need that, obviously, to make headway going into next year.

在許多方面，這與我之前關於患者返回醫生接受預防性護理以得到診斷的評論有關，希望恢復到 COVID 之前的水平，顯然我們不需要那個，明年取得進展。

But I think for the long term, it's important for patients to make sure they get into the physician's office to get diagnosed.

但我認為從長遠來看，確保患者進入醫生辦公室接受診斷很重要。

Thanks, Jake.

謝謝，傑克。

Mike?

麥克風？

First of all, you're 100% right.

首先，你是 100% 正確的。

We're looking very closely at the obesity opportunity for tirzepatide.

我們正在密切關注替西帕肽的肥胖機會。

We're very excited about just the weight loss that we saw in the type 2 diabetes patients, up to 14% weight loss, and the potential of that being even higher in the obesity population.

我們對我們在 2 型糖尿病患者中看到的體重減輕感到非常興奮，體重減輕高達 14%，而且在肥胖人群中的潛力甚至更高。

Obviously, just a massive unmet need.

顯然，這只是一個巨大的未滿足需求。

110 million Americans live with obesity.

1.1億美國人患有肥胖症。

Only about 3% of them are treated with some type of anti-obesity medication.

只有大約 3% 的人接受了某種類型的抗肥胖藥物治療。

So we think the opportunity is huge to really help people who live with chronic weight management issues.

因此，我們認為真正幫助患有慢性體重管理問題的人的機會是巨大的。

Now with our program, we have 4 trials in our SURMOUNT obesity registration program.

現在有了我們的計劃，我們的 SURMOUNT 肥胖登記計劃中有 4 項試驗。

Our first obesity trial will read out next year, our SURMOUNT-1.

我們的第一個肥胖試驗將於明年宣讀，我們的 SURMOUNT-1。

We're very excited to see that.

我們很高興看到這一點。

That should happen in mid-next year.

這應該在明年年中發生。

And then SURMOUNT-2, 3 and 4, we'll get the data.

然後 SURMOUNT-2、3 和 4，我們將獲取數據。

Those trials are on track to wrap up in '23.

這些試驗有望在 23 年結束。

And then -- so when you look at our obesity submission and approval, it looks like our approval in 2024 is the most likely outcome if everything goes well, as we expect, in our SURMOUNT program.

然後 - 因此，當您查看我們的肥胖症提交和批准時，如果我們的 SURMOUNT 計劃一切順利，那麼我們在 2024 年的批准似乎是最有可能的結果。

So very excited about Wegovy's launch.

對 Wegovy 的推出感到非常興奮。

I think they've done a nice job.

我認為他們做得很好。

I think not a surprise to us.

我認為這對我們來說並不意外。

We thought that what was holding back the current market was just the current products in the marketplace just didn't have clinically meaningful enough weight loss.

我們認為阻礙當前市場的只是市場上當前的產品沒有足夠的臨床意義減肥。

We thought if we had products on the marketplace that had clinically meaningful weight loss and those products were able to show good clinical outcomes, overall medical outcomes for those who live with obesity, that physicians would write it and payers would provide access for it.

我們認為，如果我們在市場上有具有臨床意義的減肥產品，並且這些產品能夠顯示出良好的臨床結果，對於肥胖患者的整體醫療結果，那麼醫生會編寫它並且付款人會提供訪問權限。

So it's not going to develop overnight, but we're very encouraged by the early launch of Wegovy and just very excited about tirzepatide's opportunity.

所以它不會在一夜之間發展，但我們對 Wegovy 的早期推出感到非常鼓舞，並對 tirzepatide 的機會感到非常興奮。

Thanks, Mike.

謝謝，邁克。

Seamus, thanks for your question.

Seamus，謝謝你的提問。

The next caller is Umer Raffat from Evercore.

下一位來電者是 Evercore 的 Umer Raffat。

Dan, I was very intrigued about the donanemab versus aducanumab head-to-head trial.

丹，我對 donanemab 與 aducanumab 的頭對頭試驗非常感興趣。

And my question really was, I understand the primary endpoints on amyloid plaque, but will the trial be able to gauge clinical efficacy on endpoints like CDR Sum of the Boxes?

我的問題確實是，我了解澱粉樣蛋白斑塊的主要終點，但該試驗能否評估 CDR Sum of the Boxes 等終點的臨床療效？

I asked because my understanding it's an open-label trial.

我問是因為我理解這是一個開放標籤試驗。

And then secondly, I feel like there's been a fair amount of investor debate and perhaps confusion on what exactly is Lilly messaging on the Innovent PD-1 launch in U.S. And the sort of debate ranges anywhere from Lilly will be a dominant player or not so much.

其次，我覺得有相當多的投資者辯論，也許對禮來公司在美國推出 Innovent PD-1 時傳遞的信息究竟是什麼感到困惑。而且這種辯論範圍從禮來公司是否會成為主導者很多。

So just so we're all on the same page, I guess what are you guys expecting?

所以我們都在同一個頁面上，我猜你們在期待什麼？

And do you expect it to be a meaningful PD-1 in the U.S. market?

你認為它會成為美國市場上有意義的 PD-1 嗎？

And if you could speak to your thoughts on whether data generated in Chinese patients would be a relevant commercial consideration for U.S. oncologists or not.

如果你能談談你對中國患者產生的數據是否會成為美國腫瘤學家的相關商業考慮的看法。

Thanks, Umer.

謝謝，烏默爾。

We'll go to Dan for the first question and Jake for the second.

第一個問題我們去找丹，第二個問題找傑克。

Yes.

是的。

Thanks, Umer.

謝謝，烏默爾。

Your question is whether the donanemab versus aducanumab trial -- head-to-head trial will be powered to measure clinical efficacy outcomes.

您的問題是，donanemab 與 aducanumab 試驗 - 頭對頭試驗是否能夠衡量臨床療效結果。

They will not be.

他們不會。

It is a small and a shorter trial, so we won't be able to draw conclusions about that.

這是一個小而短的試驗，所以我們無法就此得出結論。

But I'd point out that if we believe that plaque lowering is the appropriate surrogate, and that question will certainly be answered in the next year to 18 months as we get data from a number of Phase III plaque-lowering drugs -- so if it turns out that plaque lowering is an appropriate surrogate for predicting clinical efficacy, then I think that the degree and speed of plaque lowering could be the basis of comparison across different Alzheimer's drugs in the same way that surrogates in oncology are used to compare different drugs in a class, knowing that the long-term outcome trials would have to be extremely large and long duration powered for clinical outcomes.

但我要指出的是，如果我們認為降低斑塊是適當的替代品，並且隨著我們從許多 III 期降低斑塊藥物中獲得數據，這個問題肯定會在未來一年到 18 個月內得到回答——所以如果事實證明，斑塊降低是預測臨床療效的合適替代指標，那麼我認為斑塊降低的程度和速度可以作為不同阿爾茨海默病藥物比較的基礎，就像腫瘤學中的替代指標用於比較不同藥物一樣在課堂上，知道長期結果試驗必須非常大且持續時間長，才能獲得臨床結果。

I also sort of point out that we're expecting here to have a -- in the scenario where we're really excited about this, we're expecting to have a positive Phase III trial for donanemab, which in itself is a differentiator, I think, from current competitors.

我還有點指出，我們期望在這裡有一個 - 在我們對此感到非常興奮的情況下，我們期望對多納奈馬進行積極的 III 期試驗，這本身就是一個差異化因素，我認為，從目前的競爭對手。

So the head-to-head on efficacy against Aduhelm may not actually be relevant.

因此，針對 Aduhelm 的療效可能實際上並不相關。

Thanks, Dan.

謝謝，丹。

Jake?

傑克？

Thanks for the question.

謝謝你的問題。

So sintilimab, the PD-1 inhibitor from Innovent, we brought into the company in terms of ex China rights, explicitly with the intent to use pricing as a lever to disrupt the U.S. market, starting with the United States and potentially moving to Europe as well.

因此，信達（Innovent）的 PD-1 抑製劑信迪利單抗（sintilimab），我們在中國以外的權利方面引入了公司，明確意圖利用定價作為擾亂美國市場的槓桿，從美國開始，並可能轉移到歐洲作為出色地。

And as we've said publicly over the past couple of months, the intent there is really through price predominantly versus other mechanisms such as rebating, et cetera.

正如我們在過去幾個月中公開表示的那樣，其意圖實際上主要是通過價格而不是其他機制，例如回扣等。

There are certain customers out there, certain practices and care models for which this is going to be an attractive -- this is going to be an attractive tool for lowering costs to their system.

對於某些客戶、某些實踐和護理模式，這將是有吸引力的——這將成為降低系統成本的有吸引力的工具。

And unfortunately, for the way the system is designed today, there are going to be many channels for which a lower-priced option actually isn't appealing.

不幸的是，對於今天系統的設計方式，將會有許多渠道，低價選項實際上並不吸引人。

And so as you -- your question was about whether or not we intend to be a dominant player.

就像你一樣——你的問題是關於我們是否打算成為主導者。

It's hard for me to say that with any degree of assertion today.

今天我很難用任何程度的斷言來這麼說。

We will be focusing initially on the segments for which this is an attractive option given the way that their payer dynamics work.

考慮到付款人動態的運作方式，我們將首先關注那些具有吸引力的選擇的細分市場。

And today, that's not a majority by any stretch.

而今天，這絕不是多數。

But that will be our focus out of the gate should sintilimab be approved.

但如果 sintilimab 獲得批准，那將是我們關注的焦點。

On -- to your second question about whether or not the data package that's been generated for the agent will have issues with prescribers in the United States, our market research to date suggests this won't be an issue.

關於 - 關於您為代理生成的數據包是否會對美國的處方者產生問題的第二個問題，我們迄今為止的市場研究表明這不會成為問題。

But obviously, we haven't launched the product yet.

但顯然，我們還沒有推出該產品。

We haven't gotten approved yet.

我們還沒有得到批准。

So I can't say that with certainty.

所以我不能肯定地說。

But our market research suggests it won't be an issue.

但我們的市場研究表明這不會成為問題。

But really, in front of us initially is just getting the drug approved.

但實際上，擺在我們面前的最初只是讓藥物獲得批准。

And I think as you know, that's something we hope for in the early part of next year.

我想如你所知，這是我們在明年年初所希望的。

But the drug will be subject to an advisory committee, and we await the details of what that will cover.

但該藥物將受制於一個諮詢委員會，我們等待其涵蓋的細節。

Thanks, Jake.

謝謝，傑克。

Umer, thanks for your questions.

烏默爾，謝謝你的提問。

The next caller is Ronny Gal from Bernstein.

下一位來電者是來自 Bernstein 的 Ronny Gal。

Two of those, first staying with Umer's points around sintilimab in the U.S. And it's a 2 -- essentially 2-part on this one.

其中兩個，首先在美國與 Umer 在 sintilimab 周圍的觀點保持一致。這是一個 2 - 基本上是 2 部分。

First, any comments about FDA change in policy in using China-only patient population as basis of permission in the United States?

首先，關於 FDA 改變使用僅限中國的患者群體作為美國許可基礎的政策有何評論？

We've heard some things in conferences that suggest there might be some change there.

我們在會議上聽到一些事情表明那裡可能會有一些變化。

And second, on the same point, you've kind of talked about price as the dominant note here.

其次，在同一點上，您在這裡談到了價格作為主導因素。

I guess the question is more around your thinking process.

我想這個問題更多的是圍繞你的思考過程。

Pharma has struggled for a long time in commercializing low-cost products and innovative products at the same company.

長期以來，製藥公司一直在努力將同一家公司的低成本產品和創新產品商業化。

If PD-1 should have a low-cost option, why not tau?

如果 PD-1 應該有一個低成本的選擇，為什麼不 tau 呢？

Why not lebrikizumab?

為什麼不使用lebrikizumab？

What should those not follow a deep discounting strategy given the clinical profile versus other products in the same class?

鑑於臨床概況與同類其他產品相比，那些不遵循大幅折扣策略的人應該怎麼做？

And second question, given the recent impact of interchangeable Lantus, can you discuss a little bit how the insulin -- the fast-acting insulin market is different?

第二個問題，鑑於最近可互換來得時的影響，您能否討論一下胰島素——速效胰島素市場有何不同？

Assuming we will see interchangeable products there, how do the features of the market differ?

假設我們將在那裡看到可互換的產品，那麼市場的特徵有何不同？

And would that also be a market which is more amenable to adopting an interchangeable insulin?

這也是一個更適合採用可互換胰島素的市場嗎？

Thanks, Ronny.

謝謝，羅尼。

We'll go to Dave for those first couple of questions around low-cost entrants and FDA policy.

關於低成本進入者和 FDA 政策的前幾個問題，我們將去找戴夫。

And then we'll go to Mike for the question on the interchangeability of Lantus and how that can essentially read through the fast-acting insulin.

然後我們將向 Mike 詢問有關 Lantus 的可互換性以及如何從本質上解讀速效胰島素的問題。

Sure, happy to.

當然，很高興。

Maybe before we go to me on FDA, Jake, do you have any comments on the FDA comments on China data?

也許在我們就 FDA 問題找我之前，Jake，你對 FDA 對中國數據的評論有什麼意見嗎？

Yes, I think it's a good observation.

是的，我認為這是一個很好的觀察。

I think we've observed the same thing.

我想我們觀察到了同樣的事情。

The tone from D.C. does seem to have changed a bit over the past 18 months on this topic.

在過去的 18 個月裡，華盛頓特區在這個話題上的語氣似乎確實發生了一些變化。

So I think we're hearing and reading in some ways probably the same things that you guys are.

所以我認為我們在某些方面聽到和閱讀的內容可能與你們相同。

We don't have a lot more information than that, and so we await again the regulatory decision from FDA as to the acceptability of the package.

我們沒有比這更多的信息，因此我們再次等待 FDA 關於該包裹可接受性的監管決定。

As it relates, Ronny, to the broader question about why not more sort of like everyday low-price kind of strategies in the main in pharmaceuticals, I mean, I think a couple of things come to mind here.

羅尼，當它涉及到更廣泛的問題時，為什麼不更像是藥品中主要的日常低價策略，我的意思是，我認為這裡有幾件事浮現在腦海中。

First, I think in oncology in particular, it is infeasible quite often to run comparative studies.

首先，我認為特別是在腫瘤學中，經常進行比較研究是不可行的。

And so once an incumbent is established, it's very difficult to displace that incumbent.

因此，一旦建立了現任者，就很難取代現任者。

Maybe the one narrow exception might be what Jake highlighted with sintilimab where you could have a more price-sensitive segment.

也許一個狹隘的例外可能是傑克用 sintilimab 強調的，你可以擁有一個對價格更敏感的細分市場。

And here, we have analogous data from a different country that was conducted in a time gap that was prior to other PD-1s being approved in that setting.

在這裡，我們有來自不同國家的類似數據，這些數據是在其他 PD-1 在該環境中獲得批准之前的時間間隔內進行的。

And so that presents an opportunistic play.

因此，這是一場機會主義的遊戲。

We have, of course, also pursued this in insulin, and Mike can comment on that in a second.

當然，我們也在胰島素方面進行了研究，Mike 可以稍後對此發表評論。

But basically, our launch to the 30% discount to the other insulin glargine, we've pursued our own low-cost authorized generic of Humalog, now reducing the price to effectively 70% off the original brand.

但基本上，我們推出了對其他甘精胰島素 30% 的折扣，我們追求我們自己的低成本授權仿製藥 Humalog，現在將價格降低到原品牌的 70%。

But here again, it illustrates the point Jake was making, is that even in the retail side, it's not universally adopted.

但在這裡，它再次說明了 Jake 的觀點，即使在零售方面，它也沒有被普遍採用。

Today, the half-price form of Humalog and the third off-price of insulin glargine that we provide have minority market shares.

今天，我們提供的優泌樂的半價形式和甘精胰島素的第三折價具有少數市場份額。

And that's a little bit counterintuitive, but, of course, we all know the incentives of the supply chain, which do tend to favor higher-list-price products.

這有點違反直覺，但是，當然，我們都知道供應鏈的激勵措施，這確實傾向於支持更高標價的產品。

And that's, I think, where that shows up.

我認為，這就是它出現的地方。

Finally, you asked why don't we pursue this for our whole portfolio.

最後，您問我們為什麼不在我們的整個投資組合中追求這一點。

Well, I think the overriding thought for our portfolio is often to create differentiated datasets.

好吧，我認為我們投資組合的首要思想通常是創建差異化的數據集。

And one thing different from sintilimab, different from Basaglar and authorized generic Humalog is that those aren't differentiated datasets.

與 sintilimab、Basaglar 和授權的通用 Humalog 不同的一件事是，這些不是差異化的數據集。

So they're more or less interchangeable.

所以它們或多或少是可以互換的。

So when we create a new medicine, we're seeking to create something better.

因此，當我們創造一種新藥時，我們正在尋求創造更好的東西。

And in the main, that's how the system is set up.

總的來說，這就是系統的設置方式。

And that favors typically an introductory price that's similar to other innovative competitors, and then rebating and discounting to the channel to get formulary access and use.

這通常有利於與其他創新競爭對手類似的介紹性價格，然後對渠道進行回扣和折扣以獲得處方集的訪問和使用。

And that remains our main strategy.

這仍然是我們的主要戰略。

Of course, if there was some big policy shift that flattened gross to net or reduced somehow the incentives of the intermediaries, we'd take a look at that.

當然，如果有一些重大的政策轉變使總收入變平或以某種方式減少中介機構的激勵，我們會看一看。

I think our goal would be to deliver lower-cost points to consumers if we could.

我認為我們的目標是盡可能向消費者提供成本更低的積分。

Right now, mostly, the system rewards something else, and that's how we are forward planning for the portfolio that Dan was talking about.

目前，大多數情況下，系統會獎勵其他東西，這就是我們對 Dan 所說的投資組合進行前瞻性規劃的方式。

Maybe Mike has any final comments on insulin and interchangeability.

也許邁克對胰島素和可互換性有任何最終評論。

Yes.

是的。

Thanks, Dave.

謝謝，戴夫。

First of all, when we look at Semglee, it's only interchangeable with the reference product, which is Lantus, not Basaglar.

首先，當我們查看 Semglee 時，它只能與參考產品互換，即 Lantus，而不是 Basaglar。

So we do think it's going to have more of an impact on Lantus versus Basaglar.

所以我們確實認為它會對 Lantus 和 Basaglar 產生更大的影響。

I mean when you look at the meal time segments, that first reference product will be insulin aspart, not lispro.

我的意思是，當您查看用餐時間段時，第一個參考產品將是門冬胰島素，而不是賴脯。

Now I think you also have to take a look at kind of the Semglee's interchangeable biosimilar.

現在我認為你還必須看看 Semglee 的可互換生物仿製藥。

I think many stakeholders in Washington believe that Semglee interchangeable insulin would launch at a significant discounted price.

我認為華盛頓的許多利益相關者認為 Semglee 可互換胰島素將以顯著折扣價推出。

Now that hasn't been the case.

現在情況並非如此。

The net impact of Semglee interchangeable launch is actually the introduction of a higher-priced presentation, not a lower-priced presentation.

Semglee 可互換發布的淨影響實際上是引入了更高價格的演示文稿，而不是更低價格的演示文稿。

The new presentation is priced at $269 a vial versus $99 a vial, the original Semglee, which is a 273% increase.

新產品的售價為每瓶 269 美元，而最初的 Semglee 售價為每瓶 99 美元，漲幅為 273%。

So I think what you're not going to see, at least what we haven't seen, in the insulin biosimilar space is that Semglee interchangeable will really disrupt the basal insulin market.

所以我認為你不會看到，至少我們沒有看到，在胰島素生物仿製藥領域，Semglee 可互換將真正擾亂基礎胰島素市場。

Rather, what it'll do is it allow it to compete in kind of the traditional health care system that we know have gaps which we talked about earlier, which we've been trying to fill with our Insulin Value Program, with the Senior Savings Model.

相反，它會做的是讓它與我們知道存在我們之前談到的差距的傳統醫療保健系統競爭，我們一直在努力用我們的胰島素價值計劃和老年人儲蓄來填補這些差距模型。

When you look at and kind of pivot to the mealtime insulin market, mealtime insulins are a bit more complicated.

當您查看並轉向進餐時胰島素市場時，進餐時胰島素有點複雜。

They require more presentations than what you see with a basal insulin.

與您使用基礎胰島素所看到的相比，它們需要更多的演示。

So premixes.

所以預混。

Our human insulins are also included on the contracting.

我們的人胰島素也包含在合同中。

So I think the mealtime insulin is a little bit different than what you see on the basal insulin.

所以我認為進餐時的胰島素與你在基礎胰島素上看到的有點不同。

But what we've seen to date is that given Semglee's -- our price point on interchangeability, we don't think it's going to be really disruptive to the system with more work within the current system, which we feel that we can strongly defend.

但迄今為止，我們所看到的是，鑑於 Semglee 的——我們在可互換性方面的價格點，我們認為在當前系統中進行更多工作不會對系統造成真正的破壞，我們認為我們可以堅決捍衛.

At the end of the day, I think to reiterate Dave's point, I think it's better when we're focused on improvements.

最後，我想重申一下戴夫的觀點，我認為當我們專注於改進時會更好。

And with our Connected Care launch with BIF, with our weekly basal insulin, I think we're focused on really driving innovation and better patient outcomes.

隨著我們與 BIF 的 Connected Care 推出，以及我們每週的基礎胰島素，我認為我們專注於真正推動創新和更好的患者結果。

Thanks, Mike.

謝謝，邁克。

Ronny, thanks for your questions.

羅尼，謝謝你的提問。

The next caller is Kerry Holford from Berenberg.

下一位來電者是來自 Berenberg 的 Kerry Holford。

Two questions from me on (inaudible), please.

請向我提出兩個問題（聽不清）。

Firstly, on price.

首先，關於價格。

The increase in demand this quarter, we said, will be partially offset by lower realized prices.

我們說，本季度需求的增加將被較低的實際價格部分抵消。

Now (inaudible) in Q2, where you detailed higher realized prices.

現在（聽不清）在第二季度，您詳細說明了更高的實際價格。

So can you guys just talk a bit more about the dynamics and whether that influenced in any way the upcoming adjuvant launch?

那麼你們能否多談談動態以及這是否以任何方式影響了即將推出的輔助藥物？

And then secondly, on the adjuvant situation.

其次，關於輔助情況。

And Novartis has commented on their call earlier today that the FDA has stated to them the submission based on the idea of IDFS alone will be a submission as long as there's no detrimental effect on OS.

諾華今天早些時候對他們的電話發表評論說，FDA 已向他們聲明，只要對 OS 沒有不利影響，僅基於 IDFS 概念的提交將是提交。

So now I think (inaudible) in contrast to your experience.

所以現在我認為（聽不清）與你的經歷相反。

Perhaps there'd be more relaxed approach in the FDA route that had been set out for Verzenio so I'm just curious as to why you think that might be.

也許在為 Verzenio 制定的 FDA 路線中會有更寬鬆的方法，所以我很好奇你為什麼會這麼認為。

Any feedback you can give there?

您可以在那裡提供任何反饋嗎？

Great.

偉大的。

Kerry, you were kind of breaking in and out, but I think these are for Jake.

克里，你有點闖入和闖出，但我認為這些是給傑克的。

And the first question, Jake, if you didn't catch it, was about quarter-on-quarter revenue and whether that was affected by pricing in the CDK4/6 market or rather the stocking point you made earlier.

第一個問題，Jake，如果你沒聽懂的話，是關於季度收入，以及這是否受到 CDK4/6 市場定價的影響，或者更確切地說是你之前設定的庫存點。

And then I think the second point was about IDFS versus OS in the FDA's sort of policy.

然後我認為第二點是關於 FDA 政策中的 IDFS 與 OS。

I don't know if you got all that.

我不知道你有沒有得到這一切。

Yes, thanks.

對了謝謝。

On the first point, yes, I mean, the sequential quarters was really mostly related to the inventory stocking and destocking point that I made earlier.

在第一點上，是的，我的意思是，連續季度實際上主要與我之前提出的庫存庫存和去庫存點有關。

We haven't seen a ton of fluctuation in price.

我們還沒有看到價格大幅波動。

On your comment about adjuvant, I can't comment on the back and forth that Novartis had with FDA.

關於你對佐劑的評論，我無法評論諾華與 FDA 的來回。

I just am obviously not privy to that.

我只是顯然不知道這一點。

Though from what you -- the framing of your question, that actually doesn't sound particularly different than the conversation that we've had with the agency.

儘管從您的問題的框架來看，這實際上與我們與該機構的對話並沒有特別的不同。

As Dan mentioned in his prepared remarks, we've, of course, as you can imagine, gotten a fair number of questions from folks around the nature of the approval in the subgroup versus the enrolled population of monarchE, and we'll be publishing in the coming days the actual OS or overall survival data that were part of the regulatory submission.

正如丹在他準備好的講話中提到的那樣，我們當然，正如你可以想像的那樣，從人們那裡得到了相當多的問題，這些問題是關於子組中批准的性質與 monarchE 的註冊人口的性質，我們將發布在接下來的幾天裡，作為監管提交的一部分的實際 OS 或總體生存數據。

You'll see what those trends look like in both the intent-to-treat population as well as the approved subset.

您將看到這些趨勢在意向治療人群和獲批子集中的情況。

And again, trends in one direction or another, that you'll be able to interpret for yourself.

再一次，一個方向或另一個方向的趨勢，你將能夠自己解釋。

But I don't -- from what I can hear, I don't think the Novartis feedback from the agency is all that different from what we've received.

但我不——據我所知，我不認為該機構的諾華反饋與我們收到的反饋有什麼不同。

Thanks Jake.

謝謝杰克。

Kerry, thanks for your questions.

克里，謝謝你的提問。

The next question is from Vamil Divan from Mizuho Securities.

下一個問題來自瑞穗證券的 Vamil Divan。

Maybe just a couple of other topics that haven't been discussed as much.

也許只是其他幾個沒有被討論過的話題。

So one on Emgality.

所以一個關於Emgality。

It feels like the CGRP sort of market has been impacted by COVID more than some others.

感覺 CGRP 類市場受到 COVID 的影響比其他市場更大。

Maybe if you could just sort of give us a sense of the dynamics you're seeing there.

也許如果你能給我們一種你在那裡看到的動態的感覺。

And have you seen any impact from the orals that have -- orals CGRP that have entered for prevention?

你有沒有看到口腔有什麼影響——已經進入預防的口腔CGRP？

Has that had any role on Emgality or on the class in the last few months?

在過去的幾個月裡，這對 Emgality 或班級有什麼影響嗎？

And then the second one just on the JAK side.

然後是 JAK 一側的第二個。

Obviously, a lot of focus on the FDA sort of updates on that space.

顯然，很多關注 FDA 對該領域的更新。

I'm curious if you have any sort of updated timing around when you expect a new kind of final updated label for Olumiant in RA and/or a decision on the atopic dermatitis applications.

我很好奇您是否有任何更新的時間，您希望在 RA 中為 Olumiant 提供一種新的最終更新標籤和/或對特應性皮炎應用做出決定。

Thanks, Vamil.

謝謝，瓦米爾。

We'll go to Anne for the question on Emgality and Patrik for the question on Olumiant.

關於 Emgality 的問題，我們會去找 Anne，關於 Olumiant 的問題會交給 Patrik。

Great.

偉大的。

Well, thanks for the question on Emgality.

好吧，感謝關於 Emgality 的問題。

So at present, what we've seen is the total migraine prescription market has seen growth, but it's driven primarily by the total acute new patient starts and additional concomitant use.

所以目前，我們看到的是偏頭痛處方藥市場總量已經增長，但這主要是由急性新患者開始總數和額外的伴隨使用驅動的。

With the injectable class, I do think that we're still experiencing headwinds from the pandemic and increased competition in the prevention space overall.

對於注射類，我確實認為我們仍在經歷大流行的逆風和整體預防領域競爭的加劇。

We do see some variability of this across the market.

我們確實看到了整個市場的一些變化。

Some OUS markets are returning really to pre-COVID growth levels.

一些 OUS 市場正在真正恢復到 COVID 之前的增長水平。

And while we've seen improvement in the volume of new patient starts, the CGRP mAb class in the U.S. is still about 13% below where we were with the start of the pandemic.

雖然我們已經看到新患者開始數量有所改善，但美國的 CGRP mAb 類別仍比大流行開始時低約 13%。

So -- and with the new competition and then appropriate treatment for acute and prevention, we're seeing that the market should continue to grow as patients reengage in the system.

所以——隨著新的競爭以及對急性和預防的適當治療，我們看到隨著患者重新參與系統，市場應該會繼續增長。

And on your question on oral impact, I think it's still a bit early to -- early days in the launches to see how this has impacted the space in this way.

關於你關於口頭影響的問題，我認為現在還為時過早——在發布的早期，看看這如何以這種方式影響空間。

So we'll watch that carefully.

所以我們會仔細觀察。

I think our belief is that with so many patients and so much unmet need, the opportunity for these medicines, particularly the mAbs, remains significant.

我認為我們的信念是，有這麼多患者和這麼多未滿足的需求，這些藥物，特別是 mAb 的機會仍然很大。

And obviously, in the end, it comes down to what's best for that patient and how we get them to their migraine-free days, and that's one place that we think -- we believe Emgality has an advantage.

顯然，最後，歸根結底是什麼對那個病人最好，以及我們如何讓他們度過無偏頭痛的日子，這是我們認為的一個地方——我們相信 Emgality 有優勢。

So we'll continue to watch this space.

所以我們將繼續關注這個空間。

We continue to believe in the efficacy that Emgality brings to the market.

我們繼續相信 Emgality 為市場帶來的功效。

And so you'll see us continue to push forward and supporting the product.

因此，您會看到我們繼續推動和支持該產品。

Thanks, Anne.

謝謝，安妮。

Patrik?

帕特里克？

Well, thank you very much.

好的，謝謝。

In terms of the question related to rheumatoid arthritis, the FDA has requested changes to the box warning for all JAK inhibitors to include serious heart-related events, cancer, blood clots and death.

關於與類風濕性關節炎相關的問題，FDA 已要求更改所有 JAK 抑製劑的警告框，包括嚴重的心臟相關事件、癌症、血栓和死亡。

And we believe in light of that, it's most likely that the JAKs will be placed after the biologics, also for the treatment of rheumatoid arthritis.

鑑於此，我們認為 JAK 最有可能被置於生物製劑之後，也用於治療類風濕性關節炎。

And that's pretty much where Olumiant is currently placed in the U.S. So we don't see any major impact on Olumiant driven by this change.

這幾乎就是 Olumiant 目前在美國的位置。所以我們認為這種變化不會對 Olumiant 產生任何重大影響。

When we move to atopic dermatitis, we know that the FDA missed the PDUFA due to the ongoing assessment of the JAK inhibitors.

當我們轉向特應性皮炎時，我們知道 FDA 由於對 JAK 抑製劑的持續評估而錯過了 PDUFA。

And we believe also here it's most likely that the JAK inhibitors will end up being placed after the biologics.

我們還認為，JAK 抑製劑最有可能最終被置於生物製劑之後。

Despite that, we also recognize that atopic dermatitis is a very heterogeneous disease and our clinicians have a use for more tools in their toolbox.

儘管如此，我們也認識到特應性皮炎是一種非常異質的疾病，我們的臨床醫生可以在他們的工具箱中使用更多工具。

But that's what we believe is most likely moving forward.

但這就是我們認為最有可能向前發展的事情。

And we would expect some regulatory actions prior to the end of this year.

我們預計在今年年底之前會採取一些監管行動。

Thanks, Patrik.

謝謝，帕特里克。

Vamil, thanks for your questions.

瓦米爾，謝謝你的提問。

The next caller is Carter Gould from Barclays.

下一位來電者是來自巴克萊的 Carter Gould。

Maybe first for Dan, just coming back to the head-to-head study.

也許首先是丹，只是回到面對面的研究。

I don't think I've heard you say yet kind of the time period in which you're going to be measuring these reductions in amyloid.

我想我還沒有聽到你說你要測量這些澱粉樣蛋白減少的時間段。

I believe you did give up sort of second half '22 kind of timeline for reading out that result.

我相信您確實放棄了 22 年下半年的時間表來宣讀該結果。

But should we be thinking about that as like a 3-month or 6-month time point?

但我們應該將其視為 3 個月或 6 個月的時間點嗎？

Or it's just sort of the number of patients that get to below the lower limit of detection over some period?

還是只是在一段時間內低於檢測下限的患者數量？

And then maybe for Jake on the SERD class.

然後也許是 SERD 課上的 Jake。

I know you guys have expressed some cautiousness on kind of the role of SERDs in the treatment paradigm in the past.

我知道你們過去對SERD在治療範式中的作用表達了一些謹慎態度。

We started to see some of the later-stage data sort of roll out from some of your competitors.

我們開始看到您的一些競爭對手推出了一些後期數據。

I wanted to get your latest thoughts there.

我想在那裡得到你的最新想法。

And if we might start to see some of the -- your SERD combination data from the original EMBER study before year-end.

如果我們可能會在年底之前開始看到一些來自原始 EMBER 研究的 SERD 組合數據。

Thanks, Carter.

謝謝，卡特。

We'll go to Dan for the first question on the donanemab head to head and then Jake for SERD.

我們將去 Dan 回答關於 donanemab 的第一個問題，然後去 Jake 回答 SERD。

Yes.

是的。

Thanks for your question, Carter.

謝謝你的問題，卡特。

I think you're appropriately pointing out that actually both things matter in terms of plaque clearance, how fast you clear the plaques and also how deep you clear the plaques.

我認為你恰當地指出，實際上這兩件事在斑塊清除方面都很重要，清除斑塊的速度以及清除斑塊的深度。

I think in the fullness of time, when we have Phase III readouts from multiple drugs that look at efficacy, I predict those will be 2 important predictive factors in how well a drug helps patients, is how quickly and how deeply it clears plaques.

我認為，隨著時間的推移，當我們從多種藥物的 III 期讀數中看到療效時，我預測這將是兩個重要的預測因素，即藥物對患者的幫助程度，即清除斑塊的速度和深度。

I think we have significant advantages there in both aspects with donanemab.

我認為我們在使用 donanemab 的兩個方面都具有顯著優勢。

So you can be sure we'll be looking at both of those things and reporting that out, as I said, in the back half of next year.

所以你可以肯定，正如我所說，我們會在明年下半年研究這兩件事並報告出來。

Thanks, Dan.

謝謝，丹。

Jake?

傑克？

Yes.

是的。

Thanks for the questions about the oral SERD program.

感謝您提出有關口頭 SERD 計劃的問題。

We're looking forward to seeing the Radius/Menarini data at San Antonio, as I'm sure you are.

我們很期待看到聖安東尼奧的 Radius/Menarini 數據，我相信你會的。

That study is a little interesting in that it was very heavily enriched for ESR1 mutated tumors.

這項研究有點有趣，因為它非常富含 ESR1 突變的腫瘤。

And so we're interested in seeing the degree to which the effect size observed in the study was really driven by that enriched subgroup, where you would expect an outsized effect size versus a drug like fulvestrant versus in the non-ESR1 mutant patients.

因此，我們有興趣看到研究中觀察到的效應大小在多大程度上是由豐富的亞組驅動的，在這種情況下，您會期望與非 ESR1 突變患者相比，與氟維司群等藥物相比，效應大小會過大。

I think that, that question has meaningful read-through as to the overall value of the class.

我認為，這個問題對於課程的整體價值具有有意義的通讀性。

If it's really just limited or driven by the ESR1 mutants, I think that's a very different proposition than a true all-comer effect size.

如果它真的只是受到 ESR1 突變體的限製或驅動，我認為這與真正的全能效應大小完全不同。

As it relates to the combination data of ours, that -- those are data we'll probably present next year.

因為它與我們的組合數據有關，那些是我們明年可能會提供的數據。

Thanks, Jake.

謝謝，傑克。

Carter, thanks for your questions.

卡特，謝謝你的提問。

The next question is from Steve Scala from Cowen.

下一個問題來自 Cowen 的 Steve Scala。

I have a couple of questions.

我有一些問題。

First, is it not possible for Lilly to file tirzepatide for obesity in 2022 on just the SURMOUNT-1 trial with supporting weight loss data from the diabetes trials?

首先，禮來公司是否不可能在 2022 年僅在 SURMOUNT-1 試驗中提交替西帕肽治療肥胖症，並提供糖尿病試驗的減肥數據支持？

Other follow-on indications for other drugs have been approved on 1 study, and SURMOUNT-1 is a trial of 2,400 patients, so it's a big trial.

其他藥物的其他後續適應症已在 1 項研究中獲得批准，而 SURMOUNT-1 是一項針對 2,400 名患者的試驗，因此是一項大型試驗。

Second question, are you planning to use blood-based biomarkers, such as P-tau217, as companion diagnostics with the -- or within the donanemab filing.

第二個問題，您是否計劃使用基於血液的生物標誌物，例如 P-tau217，作為伴隨診斷 - 或在 donanemab 文件中。

And I think you have used the Quanterix diagnostic in the TRAILBLAZER trial, so wondering if that's part of the filing.

而且我認為您在 TRAILBLAZER 試驗中使用了 Quanterix 診斷，所以想知道這是否是文件的一部分。

Thanks, Steve.

謝謝，史蒂夫。

We'll go to Mike for the question on tirzepatide and then Dan for the question on the P-tau assay and the submission on donanemab.

我們將向 Mike 詢問關於 tirzepatide 的問題，然後向 Dan 詢問關於 P-tau 檢測的問題和關於 donanemab 的提交。

Mike?

麥克風？

Yes, Steve, good question.

是的，史蒂夫，好問題。

We -- in our discussions with the FDA, we've agreed upon 4 trials for the SURMOUNT program that make up our submission for the obesity indication for tirzepatide.

我們——在與 FDA 的討論中，我們已經就 SURMOUNT 計劃的 4 項試驗達成一致，這些試驗構成了我們提交的替西帕肽肥胖適應症的申請。

As I said earlier, those will read out -- SURMOUNT-1 will read out next year.

正如我之前所說，這些將會讀出——SURMOUNT-1 將在明年讀出。

SURMOUNT-2, 3 and 4 read out in '23, and we'll submit and expect approval in '24.

SURMOUNT-2、3 和 4 在 23 年讀出，我們將在 24 年提交並期待批准。

Based on conversations with the FDA when we set our development program, that's the current plan.

根據我們在製定開發計劃時與 FDA 的對話，這是目前的計劃。

Thanks, Mike.

謝謝，邁克。

Dan?

擔？

Thanks, Steve.

謝謝，史蒂夫。

Good question on sort of companion diagnostics and their role in FDA approval of our Alzheimer's drug.

關於伴隨診斷的種類及其在 FDA 批准我們的阿爾茨海默氏症藥物中的作用的好問題。

So I think based on what we've seen with adu, our sort of base case expectation here is that the FDA is operating under an assumption that standard of care now for Alzheimer's disease, if you are diagnosing a patient for Alzheimer's, should include biomarker confirmation of disease.

因此，我認為根據我們在 adu 中看到的情況，我們的基本案例預期是，FDA 的運作假設是，如果您要診斷阿爾茨海默病患者，現在的阿爾茨海默病護理標準應該包括生物標誌物疾病的確認。

So for that reason, my guess is that there won't be -- biomarkers won't be included in prescribing information as companion diagnostics.

因此，出於這個原因，我的猜測是不會有生物標誌物作為伴隨診斷的處方信息。

I would take the opposite position probably with payers where I think they are likely to be required for reimbursement for these medicines, but that has to be worked out.

我可能對付款人採取相反的立場，我認為他們可能需要報銷這些藥物，但這必須解決。

So those assumptions I just laid out sort of underlie our thinking about how P-tau or Amyvid or any other biomarkers, CSF, A beta, will be incorporated into labels, probably not; and into practice, probably yes.

所以我剛剛提出的這些假設是我們思考 P-tau 或 Amyvid 或任何其他生物標誌物、CSF、A beta 將如何被納入標籤的基礎，可能不會；並付諸實踐，可能是的。

And so we're proceeding accordingly to make sure that P-tau217 as well as other biomarkers can be widely available around the same time as we launch donanemab so that it can be incorporated into standards of clinical practice as a biomarker for detecting Alzheimer's pathology and triaging patients to therapy.

因此，我們正在相應地進行以確保 P-tau217 以及其他生物標誌物可以在我們推出 donanemab 的同時廣泛使用，以便將其作為檢測阿爾茨海默病病理的生物標誌物納入臨床實踐標準和對患者進行分類治療。

Thanks, Dan.

謝謝，丹。

Steve, thanks for your questions.

史蒂夫，謝謝你的提問。

Your next caller is from Matthew Harrison from Morgan Stanley.

您的下一位來電者是摩根士丹利的 Matthew Harrison。

Can you hear me?

你能聽到我嗎？

Yes.

是的。

Oh, yes.

哦是的。

Okay.

好的。

Great.

偉大的。

I was just wondering if you could comment on lebrikizumab and your sort of views on the AD market.

我只是想知道您是否可以評論 lebrikizumab 以及您對 AD 市場的看法。

And in particular, now that you've seen the OX40 data from Amgen KK, if that has any impact on how you think about the longer-term potential of that market.

特別是，既然您已經看到了來自 Amgen KK 的 OX40 數據，那麼這是否會對您對該市場的長期潛力的看法產生任何影響。

Thanks, Matthew.

謝謝，馬修。

We'll go to you, Patrik, for the question on lebrikizumab.

Patrik，我們將向您諮詢有關 lebrikizumab 的問題。

Well, thank you very much for the question.

嗯，非常感謝你的提問。

We are very encouraged by the induction, that of lebrikizumab, where we saw more than 50% of patients treated with lebrikizumab achieving an EASI of 75 And we also met all the key secondary end points.

我們對 lebrikizumab 的誘導感到非常鼓舞，我們看到超過 50% 接受 lebrikizumab 治療的患者的 EASI 達到 75，而且我們還滿足了所有關鍵的次要終點。

And we actually believe that we have an opportunity here to launch a best-in-class IL-13.

而且我們實際上相信我們有機會在這裡推出一流的 IL-13。

And currently, we are looking forward to the 52 weeks data during the first half of 2022 and a potential submission in the second half of next year.

目前，我們期待 2022 年上半年的 52 週數據以及明年下半年的潛在提交。

When it comes to the Amgen data, it doesn't change our outlook for lebri.

談到安進的數據，它並沒有改變我們對 lebri 的看法。

As I shared, we believe we have a best-in-class IL-13, and we also believe that we have a very competitive asset with the market leader.

正如我所分享的，我們相信我們擁有一流的 IL-13，我們還相信我們擁有與市場領導者競爭的資產。

And this in a market that we know there is a big unmet need and the biologic penetration is still very low and we know that there is a need for many more medications and particularly with a heterogeneous need in the marketplace.

在我們知道存在巨大未滿足需求且生物滲透率仍然很低的市場中，我們知道需要更多的藥物，特別是市場上存在異質性需求。

Thanks, Patrik.

謝謝，帕特里克。

Matthew, thanks for your questions.

馬修，謝謝你的提問。

We'll wrap up our Q&A, go to Dave for a close.

我們將結束我們的問答，去戴夫做個總結。

Great.

偉大的。

Thanks, Kevin.

謝謝，凱文。

We appreciate your participation in today's earnings call and your interest in our company.

感謝您參加今天的財報電話會議以及您對我們公司的興趣。

We continue to grow our broad commercial portfolio with strong momentum in our core business, supported by many key brands and accelerating classes.

在許多關鍵品牌和加速課程的支持下，我們的核心業務勢頭強勁，我們繼續擴大我們廣泛的商業組合。

This is complemented by a compelling pipeline with industry-leading opportunities.

與之相輔相成的是具有行業領先機會的引人注目的管道。

And we remain focused on bringing new medicines to patients and creating value for all of our stakeholders.

我們仍然專注於為患者帶來新藥，並為我們所有的利益相關者創造價值。

Thanks again for dialing in.

再次感謝您撥入。

And please follow up with Investor Relations if you have any questions we did not address on the call.

如果您有任何我們未在電話會議中解決的問題，請與投資者關係部聯繫。

And hope you have a great day.

並希望你有一個美好的一天。

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 Teleconference service.

感謝您的參與和使用 AT&T 電話會議服務。

You may now disconnect.

您現在可以斷開連接。