禮來公司 (LLY) 2018 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the third quarter 2018 earnings call.

女士們，先生們，感謝你們的支持，歡迎來到 2018 年第三季度財報電話會議。

(Operator Instructions)

（操作員說明）

As a reminder, this conference is being recorded.

提醒一下，本次會議正在錄製中。

I'd now like to turn the conference over to our host, Mr. David Ricks.

我現在想把會議交給我們的東道主 David Ricks 先生。

Please go ahead.

請繼續。

Thank you, and good morning.

謝謝你，早上好。

Thank you for joining us for Eli Lilly and Company's Q3 2018 earnings call.

感謝您參加禮來公司 2018 年第三季度財報電話會議。

I'm Dave Ricks, Lilly's Chairman and CEO.

我是禮來公司董事長兼首席執行官戴夫·里克斯。

Joining me on today's call are Josh Smiley, our Chief Financial Officer; Dr. Dan Skovronsky, the President of Lilly Research Labs and our Chief Scientific Officer; Enrique Conterno, the President of Lilly Diabetes and Lilly USA; Christi Shaw, the President of Lilly Bio-Medicines; and Anne White, who is joining us for the first time as our new President of Lilly Oncology.

加入我今天的電話會議的是我們的首席財務官 Josh Smiley；禮來研究實驗室總裁兼首席科學官 Dan Skovronsky 博士； Enrique Conterno，禮來糖尿病和禮來美國公司總裁；禮來生物醫藥總裁 Christi Shaw；和 Anne White，她是首次加入我們，擔任禮來腫瘤學新總裁。

We're also joined by Kristina Wright, Mike Czapar, Kevin Hern and Phil Johnson of the IR team.

IR 團隊的 Kristina Wright、Mike Czapar、Kevin Hern 和 Phil Johnson 也加入了我們的行列。

Please note that Josh Simmons is not on the call today as Elanco is now having their own quarterly earnings calls, including their first call earlier this morning.

請注意，喬什·西蒙斯今天不在電話會議上，因為 Elanco 現在有自己的季度收益電話會議，包括他們今天早上早些時候的第一次電話會議。

Subsequent questions regarding their business performance and outlook should be directed to Elanco's Investor Relations team.

有關其業務績效和前景的後續問題應直接向 Elanco 的投資者關係團隊提出。

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

在這次電話會議中，我們預計會根據我們目前的預期做出預測和前瞻性陳述。

Our actual results could differ materially due to a number of factors, including those listed on Slide 3 and those outlined in our latest forms 10-K and 10-Q filed at the SEC.

由於多種因素，我們的實際結果可能存在重大差異，包括幻燈片 3 中列出的因素以及我們在 SEC 提交的最新表格 10-K 和 10-Q 中概述的因素。

The information we provide about our products and our 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 it is not sufficient for prescribing decisions.

它不是為了促銷，也不足以做出處方決定。

We continued our strong performance in 2018 with a third quarter revenue growth of 7% non-GAAP -- and non-GAAP operating income of 29% and non-GAAP EPS growth of 32%.

我們在 2018 年繼續保持強勁表現，第三季度非 GAAP 收入增長 7%，非 GAAP 營業收入增長 29%，非 GAAP 每股收益增長 32%。

New pharmaceutical products, which now represent 35% of human pharma revenue in the quarter, continue to be the driver of our worldwide growth, led by Trulicity, Taltz and Verzenio.

新醫藥產品目前佔本季度人類醫藥收入的 35%，繼續成為我們全球增長的驅動力，由 Trulicity、Taltz 和 Verzenio 領導。

New products continue to drive strong, volume-based growth, highlighted by the 14% pharma volume growth and the 30% U.S. diabetes volume growth.

新產品繼續推動基於銷量的強勁增長，其中突出的是 14% 的製藥銷量增長和 30% 的美國糖尿病銷量增長。

We continue to expand our margins this quarter.

本季度我們繼續擴大利潤率。

Excluding the effect of FX on international inventories sold, non-GAAP gross margin as a percent of revenue increased by nearly 110 basis points over Q3 2017, and non-GAAP operating income as a percent of revenue increased by over 380 basis points to 28.1%.

排除外匯對已售國際庫存的影響，非 GAAP 毛利率佔收入的百分比比 2017 年第三季度增加了近 110 個基點，非 GAAP 營業收入佔收入的百分比增加了 380 個基點以上，達到 28.1% .

We made significant progress with the pipeline this quarter, including the approval and launch of Emgality in the U.S., a positive CHMP opinion for Emgality in Europe, the submission of lasmiditan in the U.S., as well as positive Phase III readouts for Ultra Rapid Lispro in type 1 and type 2 diabetes patients and a positive Phase II readout for GIP/GLP, which is now called tirzepatide, in type 2 diabetes.

本季度我們在管道方面取得了重大進展，包括 Emgality 在美國的批准和啟動、對 Emgality 在歐洲的積極 CHMP 意見、在美國提交 lasmiditan 以及在 Ultra Rapid Lispro 的積極 III 期讀數1 型和 2 型糖尿病患者以及 GIP/GLP（現在稱為 tirzepatide）在 2 型糖尿病中的陽性 II 期讀數。

And we announced yesterday that Trulicity demonstrated superiority in the reduction of major adverse cardiovascular events across a broad range of people with type 2 diabetes in the precedent-setting REWIND trial.

我們昨天宣布，在開創先例的 REWIND 試驗中，Trulicity 在減少廣泛的 2 型糖尿病患者的主要不良心血管事件方面表現出優越性。

These results are important for the millions of people with type 2 diabetes who face a higher risk for CV disease.

這些結果對數百萬面臨更高心血管疾病風險的 2 型糖尿病患者非常重要。

We will submit this data to regulatory authorities and plan to present the detailed data at ADA in 2019.

我們會將這些數據提交給監管機構，併計劃在 2019 年的 ADA 上展示詳細數據。

These extended data, along with Trulicity's proven, powerful efficacy, simply delivered further validate Trulicity as a well-established option for people with diabetes.

這些擴展數據，連同 Trulicity 久經考驗的強大功效，簡單地提供了進一步驗證 Trulicity 作為糖尿病患者行之有效的選擇。

In terms of capital deployment, Elanco Animal Health became a publicly traded company via a well-received initial public offering.

在資本配置方面，Elanco Animal Health 通過首次公開募股成為上市公司。

Through the IPO and the associated debt offering, Elanco raised over $4 billion in capital, the vast majority of which was provided to Lilly as partial consideration for the animal health business that Lilly transferred to Elanco in connection with the IPO.

通過 IPO 和相關的債務發行，Elanco 籌集了超過 40 億美元的資金，其中絕大多數提供給禮來公司，作為禮來公司在 IPO 中轉讓給 Elanco 的動物保健業務的部分對價。

We announced several business development transactions, including a licensing agreement with Chugai Pharmaceutical for an oral GLP-1 agonist; a licensing and research collaboration with Dicerna Pharmaceuticals, utilizing their RNAi technology platform; a collaboration with NextCure, Inc.

我們宣布了幾項業務發展交易，包括與 Chugai Pharmaceutical 就口服 GLP-1 激動劑達成的許可協議；與 Dicerna Pharmaceuticals 的許可和研究合作，利用他們的 RNAi 技術平台；與 NextCure, Inc. 的合作。

focused on discovery and development of novel immuno-oncology cancer therapies; and we purchased a Priority Review Voucher; we returned nearly $600 million via the dividend; and we repurchased 100 -- or $1 billion of stock.

專注於發現和開發新型免疫腫瘤學癌症療法；我們購買了優先審查券；我們通過股息返還了近 6 億美元；我們回購了 100 - 或 10 億美元的股票。

Moving on to slides 5 and 6, you'll see more detail on key events since our July earnings call.

轉到幻燈片 5 和 6，您將看到自 7 月財報電話會議以來有關關鍵事件的更多詳細信息。

Now I'll turn the call over to Josh to review our Q3 results and to provide an update on our financial guidance for 2018.

現在，我將把電話轉給喬什，以審查我們的第三季度業績，並提供我們 2018 年財務指導的最新信息。

Thanks, Dave, and good morning.

謝謝，戴夫，早上好。

Slide 7 summarizes our presentation of GAAP results and non-GAAP measures, while Slide 8 provides a summary of our GAAP results.

幻燈片 7 總結了我們對 GAAP 結果和非 GAAP 措施的介紹，而幻燈片 8 提供了我們的 GAAP 結果的摘要。

I'll focus my comments on our non-GAAP adjusted measures to provide insights into the underlying trends in our business, So please refer to today's earnings press release for a detailed description of the year-on-year changes on our third quarter GAAP results.

我將把我的評論集中在我們的非公認會計原則調整措施上，以提供對我們業務潛在趨勢的洞察，因此請參閱今天的收益新聞稿，詳細描述我們第三季度公認會計原則結果的同比變化.

Looking at the non-GAAP measures on Slide 9, you'll see the revenue increase of 7% that Dave mentioned earlier.

查看幻燈片 9 上的非 GAAP 指標，您會看到 Dave 之前提到的 7% 的收入增長。

Gross margin as a percent of revenue increased to 76.7%.

毛利率佔收入的百分比增加到 76.7%。

Excluding the effect of foreign exchange rates on international inventories sold, gross margin as a percent of revenue increased nearly 110 basis points, primarily driven by manufacturing efficiencies and, to a lesser extent, the favorable impact of product mix, partially offset by the negative impact of price on our revenue.

排除匯率對國際銷售庫存的影響，毛利率佔收入的百分比增加了近 110 個基點，主要受製造效率的推動，在較小程度上受產品組合的有利影響，部分被負面影響所抵消我們收入的價格。

Total operating expense increased roughly 1%, with marketing, selling and administrative expense increasing 2% while R&D expense remained relatively flat.

總運營費用增長約 1%，營銷、銷售和管理費用增長 2%，而研發費用保持相對平穩。

Total operating expense as a percent of revenue compared to Q3 2017 declined 275 basis points to 48.8%, benefiting from previously announced actions taken to reduce the company's cost structure.

與 2017 年第三季度相比，總運營費用佔收入的百分比下降 275 個基點至 48.8%，這得益於之前宣布的降低公司成本結構的行動。

Operating income increased 29% compared to Q3 2017, which put our operating margin at 27.9% for the quarter.

與 2017 年第三季度相比，營業收入增長了 29%，這使我們本季度的營業利潤率為 27.9%。

And as Dave mentioned earlier, excluding the effect of FX on international inventories sold, our operating income was 28.1% of revenues, an improvement of over 380 basis points versus last year's quarter.

正如戴夫之前提到的，不包括外匯對銷售的國際庫存的影響，我們的營業收入佔收入的 28.1%，與去年同期相比提高了 380 多個基點。

Other income and expense was expense of $15.4 million this quarter compared to income of $49.9 million in last year's quarter.

本季度的其他收入和支出為 1540 萬美元，而去年同期的收入為 4990 萬美元。

Our tax rate was 15.1%, a decrease of 380 basis points compared with the same quarter last year, driven primarily by the impact of U.S. tax reform.

我們的稅率為 15.1%，與去年同期相比下降了 380 個基點，主要受美國稅制改革的影響。

At the bottom line, net income increased 29%, while earnings per share increased slightly faster at 32% due to reduction in shares outstanding from share repurchases.

歸根結底，淨收入增長了 29%，而由於股票回購流通股減少，每股收益增長略快，達到 32%。

We achieved the significant earnings growth by delivering high single-digit revenue growth while carefully managing our operating expenses, significantly improving profitability again this quarter.

我們通過實現高個位數的收入增長，同時謹慎管理我們的運營費用，實現了顯著的盈利增長，本季度的盈利能力再次顯著提高。

Slide 10 details these same non-GAAP measures for September year-to-date, while Slide 11 provides a reconciliation between reported and non-GAAP EPS.

幻燈片 10 詳細介紹了今年 9 月至今的這些相同的非 GAAP 措施，而幻燈片 11 提供了報告的和非 GAAP 每股收益之間的對賬。

You'll find additional details on these adjustments on slides 23 and 24.

您可以在幻燈片 23 和 24 上找到有關這些調整的更多詳細信息。

Moving to Slide 12.

轉到幻燈片 12。

Let's take a look at the effect of price, rate and volume on revenue growth.

讓我們看看價格、費率和數量對收入增長的影響。

This quarter, foreign exchange had a modest effect on revenue.

本季度，外匯對收入的影響不大。

Our worldwide revenue growth on a performance basis was 8%, driven by a 12% increase in volume, partially offset by price.

在銷量增長 12% 的推動下，我們在業績基礎上的全球收入增長為 8%，部分被價格抵消。

Q3 represented the seventh straight quarter our human pharma business delivered volume growth in each major geography.

第三季度是我們的人類製藥業務連續第七個季度在每個主要地區實現銷量增長。

U.S. pharma revenue increased 11%, driven by impressive volume growth of 17%, led by Trulicity, Basaglar, Taltz and Verzenio, partially offset by price.

在 Trulicity、Basaglar、Taltz 和 Verzenio 的帶動下，美國製藥業收入增長了 17%，部分被價格所抵消。

And Dave mentioned earlier our U.S. diabetes business delivered 30% volume growth yet again this quarter.

戴夫早些時候提到我們的美國糖尿病業務本季度再次實現了 30% 的銷量增長。

This performance affirms our volume-based growth strategy is critical as we grow through an evolving U.S. pricing environment.

這一表現證實了我們基於數量的增長戰略對於我們在不斷變化的美國定價環境中的發展至關重要。

You will see U.S. price declined 6% this quarter.

你會看到本季度美國價格下跌 6%。

Nearly 3 points of the U.S. price decline was driven by new access and corresponding volume for Basaglar in Medicare Part D, which we didn't have in last year's quarter.

美國價格下跌近 3 個百分點是由醫療保險 D 部分中 Basaglar 的新准入和相應數量推動的，這是我們去年季度沒有的。

We also have approximately 2 points of the decline associated with increases to our patient affordability and access programs for Taltz and Humalog, which also drove increased volumes.

我們也有大約 2 個點的下降與我們的患者負擔能力和 Taltz 和 Humalog 訪問計劃的增加相關，這也推動了數量的增加。

The remaining point of decline is the net effect of changes to estimates and rebates and discounts across segments, partially offset by the impact of price increases we took late last year and early this year.

其餘的下降點是估計變化的淨影響以及跨部門的回扣和折扣，部分被我們去年底和今年年初價格上漲的影響所抵消。

Moving to Europe.

搬到歐洲。

Pharma revenue grew 1% driven by volume, largely offset by price.

製藥收入在銷量的推動下增長了 1%，但在很大程度上被價格所抵消。

This volume growth was achieved despite the loss of exclusivity for Cialis.

儘管失去了 Cialis 的排他性，但還是實現了這一銷量增長。

Excluding the impact of the Cialis LOE, volume grew over 15%.

排除 Cialis LOE 的影響，銷量增長超過 15%。

This robust volume growth was led by Olumiant, Trulicity, Taltz, Lartruvo and Jardiance.

這種強勁的銷量增長是由 Olumiant、Trulicity、Taltz、Lartruvo 和 Jardiance 引領的。

In Japan, pharma revenue decreased 2% with volume growth more than offset by price and the impact of the biannual price cuts which took effect in Q1.

在日本，製藥收入下降 2%，但銷量增長被價格和第一季度生效的半年度降價的影響所抵消。

Volume growth was driven by new products, namely Trulicity, Olumiant, Taltz and Jardiance, with a significant contribution also coming from Cymbalta.

銷量增長是由新產品推動的，即 Trulicity、Olumiant、Taltz 和 Jardiance，Cymbalta 也做出了重大貢獻。

Our pharma revenue in the rest of world increased 15% on a performance basis this quarter, led by volume growth from new products, namely Trulicity, Cyramza, Jardiance, Lartruvo, Taltz and Basaglar, as well as strong volume growth from Humalog.

本季度，我們在世界其他地區的製藥收入增長了 15%，這主要得益於 Trulicity、Cyramza、Jardiance、Lartruvo、Taltz 和 Basaglar 等新產品的銷量增長，以及 Humalog 的強勁銷量增長。

Turning to animal health.

轉向動物健康。

Total worldwide revenue grew 6% on a performance basis this quarter, driven by higher prices and higher volume.

受價格上漲和銷量增加的推動，本季度全球總收入按業績增長 6%。

Higher sales of companion animal disease prevention, ruminants and swine, and companion animal therapeutics products were partially offset by lower sales of products that are being exited, including the products which Lilly has retained control of after the Elanco IPO.

伴侶動物疾病預防、反芻動物和豬以及伴侶動物治療產品的較高銷售額被正在退出的產品的較低銷售額部分抵消，其中包括禮來在 Elanco 首次公開募股後保留控制的產品。

Slide 13 outlines the same information for our September and year-to-date results.

幻燈片 13 概述了我們 9 月和年初至今結果的相同信息。

Now let's take a look at the drivers of our 12% worldwide volume growth on Slide 14.

現在讓我們在幻燈片 14 上看一下我們 12% 的全球銷量增長的驅動因素。

In total, our new products, including Trulicity, Taltz, Basaglar, Verzenio, Olumiant, Jardiance, Lartruvo and Cyramza, were the engines of our worldwide volume growth.

總的來說，我們的新產品，包括 Trulicity、Taltz、Basaglar、Verzenio、Olumiant、Jardiance、Lartruvo 和 Cyramza，是我們全球銷量增長的引擎。

You can see that these products drove 13.8 percentage points of volume growth this quarter.

您可以看到，這些產品在本季度推動了 13.8 個百分點的銷量增長。

This robust pharma volume growth represented our strongest quarterly volume performance this decade.

這種強勁的醫藥銷量增長代表了我們十年來最強勁的季度銷量表現。

The loss of exclusivity for Strattera, Effient, Zyprexa, Axiron, Evista and Cymbalta provided a drag of 110 basis points while Cialis accounted for 190 basis points of volume decline.

Strattera、Effient、Zyprexa、Axiron、Evista 和 Cymbalta 的獨家經營權的喪失拖累了 110 個基點，而 Cialis 的銷量下降了 190 個基點。

At the end of September, generic versions of Cialis entered the U.S. market, which is expected to result in rapid erosion of sales.

9 月底，Cialis 的仿製藥進入美國市場，預計這將導致銷售額迅速下降。

When excluding LOEs and Cialis, the rest of our products had volume growth of approximately 19%.

排除 LOE 和 Cialis 後，我們其餘產品的銷量增長約為 19%。

Slide 15 provides a view of our new product update.

幻燈片 15 提供了我們新產品更新的視圖。

In total, these brands generated nearly $1.9 billion in revenue this quarter, representing 31% of our total worldwide revenue and 35% of our human pharmaceutical revenue.

總的來說，這些品牌本季度創造了近 19 億美元的收入，占我們全球總收入的 31% 和我們人用藥物收入的 35%。

With the launch of Emgality and the submission of lasmiditan, we look forward to adding a fourth leg to our new product growth story, joining recent launches in diabetes, oncology and immunology and demonstrating that Lilly is also building an innovative pain franchise.

隨著 Emgality 的推出和 lasmiditan 的提交，我們期待為我們的新產品增長故事增添第四條腿，加入最近在糖尿病、腫瘤學和免疫學領域的發布，並證明禮來也在建立一個創新的疼痛特許經營權。

Moving to Slide 16.

轉到幻燈片 16。

Continuing with our non-GAAP explanations, this quarter the effect of FX had a relatively minimal impact on our income statement, with a small negative impact on revenue and a small positive impact on earnings.

繼續我們的非公認會計準則解釋，本季度外彙的影響對我們的損益表的影響相對較小，對收入的負面影響較小，對收益的影響較小。

Turning to our 2018 financial guidance on Slide 17, you will see that we've updated our non-GAAP guidance to reflect our continued strong operational performance.

轉到我們在幻燈片 17 上的 2018 年財務指導，您會看到我們已經更新了我們的非公認會計準則指導，以反映我們持續強勁的運營業績。

We're narrowing the range for revenue to $24.3 billion to $24.5 billion, narrowing the range for SG&A expense to $6.3 billion to $6.5 billion, decreasing our tax rate from 17% to 16% due primarily to recently issued guidance on elements of U.S. tax reform, and we're raising and narrowing our non-GAAP earnings per share range to $5.55 to $5.60.

我們將收入範圍縮小到 243 億美元到 245 億美元，將 SG&A 費用範圍縮小到 63 億美元到 65 億美元，將我們的稅率從 17% 降低到 16%，這主要是由於最近發布了關於美國稅制改革要素的指南，我們正在將我們的非公認會計原則每股收益範圍提高並縮小至 5.55 美元至 5.60 美元。

At the midpoint of the ranges represents an increase of 30% over 2017.

在範圍的中點表示比 2017 年增加了 30%。

I would note that this revised EPS range assumes a $0.02 to $0.03 negative impact from backing out the noncontrolling interest portion of Elanco profits in the fourth quarter, which had not been included in the prior guidance.

我要注意的是，這個修訂後的每股收益範圍假設了 0.02 美元到 0.03 美元的負面影響，因為取消了第四季度 Elanco 利潤的非控制性權益部分，該部分未包含在先前的指導中。

Our updated guidance implies fourth quarter non-GAAP EPS of between $1.33 and $1.38, which exceeds current consensus.

我們更新後的指引暗示第四季度非公認會計原則每股收益在 1.33 美元至 1.38 美元之間，超出了目前的共識。

However, it is lower than our third quarter EPS due to the entry of generic competition for Cialis in the U.S. in late September; higher fourth quarter R&D expenses to support additional late-stage investment, including mirikizumab, Olumiant and Taltz NILEX as well as pegilodecakin and GIP/GLP and launch investments for Emgality; and finally, the minority interests attributed to Elanco that I mentioned earlier.

然而，由於 9 月底 Cialis 在美國的仿製藥競爭進入，它低於我們第三季度的每股收益；增加第四季度研發費用以支持額外的後期投資，包括 mirikizumab、Olumiant 和 Taltz NILEX 以及 pegilodecakin 和 GIP/GLP，並啟動對 Emgality 的投資；最後，我之前提到的 Elanco 的少數股東權益。

On a reported basis, earnings per share for 2018 is now expected to be in the range of $3.04 to $3.09 (corrected by company after the call).

據報導，現在預計 2018 年的每股收益在 3.04 美元至 3.09 美元之間（在電話會議後由公司更正）。

In total, we expect strong full year performance led by volume gains in our new products, which allows for targeted investments in our long-term portfolio and positions us well to achieve our 2020 financial objectives.

總體而言，我們預計新產品銷量增長將帶動全年業績強勁，這使得我們可以對我們的長期投資組合進行有針對性的投資，並使我們能夠很好地實現我們的 2020 年財務目標。

This robust performance, along with the capital raised from the Elanco transaction, provide strong cash flow, which we're deploying thoughtfully across our capital allocation priorities.

這種強勁的表現，加上從 Elanco 交易中籌集的資金，提供了強勁的現金流，我們在我們的資本分配優先事項中進行了深思熟慮的部署。

As we move forward in line with our strategy, we will continue to prioritize funding our existing market products, new launches, life cycle opportunities and in replenishing our pipeline.

隨著我們按照我們的戰略向前推進，我們將繼續優先為我們現有的市場產品、新產品發布、生命週期機會和補充我們的管道提供資金。

In addition, we continue to leverage business development to upgrade our pipeline and future growth prospects, as you saw with several recent announcements of business development deals.

此外，我們繼續利用業務發展來升級我們的管道和未來的增長前景，正如您在最近的幾項業務發展交易公告中看到的那樣。

Finally, we'll return excess cash to shareholders via increases to the dividend and share buybacks.

最後，我們將通過增加股息和股票回購將多餘的現金返還給股東。

Now I will turn the call back over to Dave to review the pipeline and key future events.

現在，我將把電話轉回給 Dave，以審查管道和未來的關鍵事件。

Thanks, Josh.

謝謝，喬希。

So Slide 18 shows select pipeline opportunities as of October 30.

因此，幻燈片 18 顯示了截至 10 月 30 日的選定管道機會。

In my summary of the quarter at the beginning of the call, I mentioned the positive movements for Emgality and lasmiditan.

在電話會議開始時的季度總結中，我提到了 Emgality 和 lasmiditan 的積極動向。

Additional movements since our last earnings call includes: the start of a Phase III study for Olumiant in lupus and the start of a Phase II/III adaptive study for Olumiant in alopecia areata, the attrition of Cyramza's second-line bladder/cancer indication from Phase III and the attrition of the N3pG plus BACE combo arm from the ongoing phase II.

自我們上次財報電話會議以來的其他變動包括：開始對 Olumiant 治療狼瘡進行 III 期研究，開始對 Olumiant 治療斑禿進行 II/III 期適應性研究，Cyramza 的二線膀胱/癌症適應症從 Phase 開始流失III 和 N3pG 加 BACE 組合臂從正在進行的 II 期中流失。

Please note we're still studying N3pG as a monotherapy in Phase II.

請注意，我們仍在研究 N3pG 作為 II 期的單一療法。

On Slide 19, we provide an update on expected key events for 2018.

在幻燈片 19 上，我們提供了 2018 年預期關鍵事件的最新信息。

In addition to the pipeline movement and regulatory actions I've already noted, you'll see that we've added a new line to reflect our expectation to submit Taltz for axial spondyloarthritis to regulatory authorities by the end of the year.

除了我已經註意到的管道移動和監管行動之外，您會看到我們添加了一條新線路，以反映我們希望在今年年底前向監管機構提交 Taltz 治療中軸型脊柱關節炎。

In addition, the FDA has granted breakthrough designation to Emgality for the cluster headache indication.

此外，FDA 已授予 Emgality 用於叢集性頭痛適應症的突破性認定。

And you'll see that we've added a new line to reflect our plans to submit this indication by year-end.

您會看到我們添加了一個新行來反映我們計劃在年底之前提交此指示。

Under Regulatory Actions, you'll see the approval of Verzenio in Europe and Verzenio in Japan and the approval of fruquintinib in China under the tradename Elunate.

在監管行動下，您將看到 Verzenio 在歐洲的批准和 Verzenio 在日本的批准，以及呋喹替尼在中國的批准，商品名為 Elunate。

Under Regulatory Submissions, you'll see the submission of a new indication for Cyramza in Europe and Japan for second-line liver cancer.

在監管提交下，您將看到 Cyramza 在歐洲和日本提交的用於二線肝癌的新適應症。

In the Phase III Data Presentations and Publications section, we reflect the presentations at EASD of the EASE 2 and 3 studies in type 1 diabetes for empagliflozin, as well as the CARMELINA CV outcomes study for Trajenta in collaboration with Boehringer Ingelheim, in addition to the presentations at ACR of the COAST-V and COAST-W axial spondyloarthritis studies for ixekizumab.

在 III 期數據展示和出版物部分，我們反映了在 EASD 上關於 empagliflozin 的 1 型糖尿病 EASE 2 和 3 研究的展示，以及 Trajenta 與 Boehringer Ingelheim 合作的 CARMELINA CV 結果研究，以及在 ACR 上關於 ixekizumab 的 COAST-V 和 COAST-W 軸性脊柱關節炎研究報告。

And in Phase III Top Line Data Disclosures section, in addition to the Phase III readouts for Trulicity and Ultra Rapid Lispro, which I mentioned earlier, we also had a positive Phase III read-out for flortaucipir, our tau imaging agent.

在 III 期 Top Line 數據披露部分，除了我之前提到的 Trulicity 和 Ultra Rapid Lispro 的 III 期讀數外，我們的 tau 顯像劑 flortaucipir 的 III 期讀數也呈陽性。

This was another productive quarter, contributing to continued pipeline advancement in 2018.

這是另一個富有成效的季度，有助於在 2018 年繼續推進管道。

Before we go to the Q&A section, let me briefly sum up the progress we made this quarter.

在進入問答部分之前，讓我簡要總結一下我們本季度取得的進展。

In Q3, we continued our strong operating performance in 2018, delivering 7% revenue growth and 12% volume growth, driven by our newest products.

在第三季度，我們在 2018 年繼續保持強勁的經營業績，在我們最新產品的推動下實現了 7% 的收入增長和 12% 的銷量增長。

As Josh stated earlier, our pharma volume growth was the strongest this decade.

正如 Josh 之前所說，我們的製藥量增長是近十年來最強勁的。

We continue to realize significant efficiencies in our cost structure, leading to operating margin expansion of over 380 basis points, excluding the impact of foreign exchange on international inventories sold.

我們繼續實現成本結構的顯著效率，導致營業利潤率擴大超過 380 個基點，不包括外匯對國際銷售庫存的影響。

We have made excellent progress in our pipeline this quarter as well: the approval and launch of Emgality for migraine patients in the U.S., this is our 10th new product launch since 2014; the FDA submission of lasmiditan for acute migraine; positive Phase III data for Ultra Rapid Lispro; the presentation of exciting Phase II data for tirzepatide in type 2 diabetes; and just yesterday's news that Trulicity demonstrated superiority in the reduction of major adverse cardiovascular events across a broad range of people with type 2 diabetes in the precedent-setting REWIND trial.

本季度我們的管道也取得了出色的進展：Emgality 在美國的偏頭痛患者獲得批准和推出，這是我們自 2014 年以來推出的第 10 個新產品； FDA 提交的用於急性偏頭痛的 lasmiditan； Ultra Rapid Lispro 的 III 期陽性數據； 2 型糖尿病中 tirzepatide 令人興奮的 II 期數據的呈現；就在昨天的新聞中，Trulicity 在開創性的 REWIND 試驗中證明了在減少廣泛的 2 型糖尿病患者的主要不良心血管事件方面具有優勢。

We also returned $1.6 billion to shareholders via dividend and share repurchases.

我們還通過股息和股票回購向股東返還了 16 億美元。

We completed the Elanco IPO and bolstered our early-phase pipeline with the additional of an oral GLP-1 while completing several other business development deals.

我們完成了 Elanco 首次公開募股，並通過額外的口服 GLP-1 鞏固了我們的早期管道，同時完成了其他幾項業務開發交易。

This concludes our prepared remarks.

我們準備好的評論到此結束。

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

現在我將把電話轉給 Phil 來主持問答環節。

Great.

偉大的。

Thank you, Dave.

謝謝你，戴夫。

As in prior calls, we would like to take as many questions as possible during the Q&A session (Operator Instructions) Also, given some scheduling issues on our side and the fact that in recent calls, we have not exhausted the full 90 minutes we had scheduled, we do intend to conclude today's call at 10:15.

與之前的電話一樣，我們希望在問答環節（操作員說明）期間回答盡可能多的問題。此外，考慮到我們這邊的一些日程安排問題以及在最近的電話中，我們沒有用完完整的 90 分鐘按照計劃，我們確實打算在 10:15 結束今天的電話會議。

So with that, Lola, if you could provide the instructions for the Q&A session, and then we're ready for the first caller.

因此，Lola，如果你能提供問答環節的說明，那麼我們就可以接聽第一個來電者了。

(Operator Instructions) And first, we'll go to the line of Chris Schott with JPMorgan.

（操作員說明）首先，我們將與摩根大通聯繫 Chris Schott。

My first one was on REWIND results.

我的第一個是 REWIND 結果。

I think you referred to them as precedent setting.

我認為您將它們稱為先例設置。

I know you're showing the full data next summer, but any additional color you can provide as we try to think about those results in context of prior GLP-1 CV outcome studies as we've had kind of this balance of healthier patients versus longer follow-up in that study?

我知道您將在明年夏天展示完整的數據，但是當我們嘗試在先前 GLP-1 CV 結果研究的背景下考慮這些結果時，您可以提供任何其他顏色，因為我們已經在更健康的患者與更健康的患者之間取得了某種平衡在該研究中進行更長時間的隨訪？

My second question, you touched a little bit on it in the prepared remarks, but the diabetes portfolio in 3Q, I think we had a few products coming in a bit below expectations after some very strong first half results.

我的第二個問題，你在準備好的評論中提到了一點，但是在第三季度的糖尿病產品組合中，我認為在上半年業績非常強勁之後，我們有一些產品的表現略低於預期。

Can you just talk about any color in terms of was there any kind of onetime issues maybe about Humalog or Basaglar that affected this quarter's results?

你能談談任何顏色嗎？是否有任何關於 Humalog 或 Basaglar 的一次性問題影響了本季度的業績？

Thank you for the questions, Chris.

謝謝你的問題，克里斯。

Enrique, those are both for you.

恩里克，這兩個都是給你的。

Very good.

很好。

REWIND is indeed a precedent-setting trial.

REWIND 確實是一個開創性的試驗。

It included the majority of patients without -- with type 2 diabetes but without cardiovascular disease.

它包括大多數沒有 2 型糖尿病但沒有心血管疾病的患者。

It also had the longest median follow-up, over 5 years, and a low A1c baseline of 7.3.

它的中位隨訪時間最長，超過 5 年，A1c 基線低至 7.3。

I think what we can share at this stage is really what's in the press release.

我認為我們在這個階段可以分享的實際上是新聞稿中的內容。

We will not be sharing more information on REWIND until our intended detailed presentation at ADA next year.

在我們明年在 ADA 上進行詳細介紹之前，我們不會分享有關 REWIND 的更多信息。

We do intend to submit in 2019 for a new indication.

我們確實打算在 2019 年提交新的適應症。

Related to Humalog and Basaglar and the overall diabetes portfolio first, I think we're very pleased with the overall volume growth when it comes to the diabetes portfolio.

首先與 Humalog 和 Basaglar 以及整體糖尿病產品組合相關，我認為我們對糖尿病產品組合的整體銷量增長感到非常滿意。

Clearly, when it comes to Humalog, we did see a 14% price decline vis-à-vis Q3 of 2017.

顯然，就 Humalog 而言，我們確實看到與 2017 年第三季度相比價格下跌了 14%。

And just to provide maybe a little more color on this, we are seeing an unfavorable segment mix, about 8 points of that 14.

只是為了提供更多的色彩，我們看到了一個不利的細分組合，大約 14 個點中的 8 個。

Patient affordability is impacting the insulin portfolio.

患者的負擔能力正在影響胰島素組合。

That's another 4 points.

這又是4分。

And then we had an unfavorable prior period adjustment as a comparator to last year's quarter.

然後我們有一個不利的前期調整作為去年季度的比較。

And maybe to provide and try to be a little more detailed, we do see a lot of volatility with Humalog.

也許為了提供並嘗試更詳細一點，我們確實看到了 Humalog 的很多波動。

It is better to look at this product than a year-to-date basis.

看這個產品比看年初至今更好。

And when we look at it on a year-to-date basis, I think the trend that we basically see is mid-single-digit erosion on price.

當我們從年初至今來看它時，我認為我們基本上看到的趨勢是價格的中位數侵蝕。

The dynamics on Basaglar are slightly different in that Basaglar did not have any access in Part D and the fact that we first gained this year.

Basaglar 的動態略有不同，因為 Basaglar 在 D 部分中沒有任何訪問權限以及我們今年首次獲得的事實。

So when we look at our compare, we are comparing on a segment that is highly rebated, and that basically has an impact on price.

因此，當我們查看我們的比較時，我們正在比較一個高回扣的細分市場，這基本上會對價格產生影響。

Now when we look at Q2 of '18 versus Q3 of '18 for Basaglar, there's some price erosion but not the same money that you see year-on-year.

現在，當我們查看 Basaglar 的 18 年第二季度與 18 年第三季度時，價格會有所下降，但與去年同期相比有所不同。

Great.

偉大的。

Enrique, thank you for the answers.

恩里克，謝謝你的回答。

And next, we'll go to the line of Tim Anderson with Wolfe Research.

接下來，我們將與 Wolfe Research 一起前往 Tim Anderson 的路線。

A couple of questions.

幾個問題。

2019, can you talk about tailwinds and headwinds?

2019，你能談談順風和逆風嗎？

I know you won't be giving official guidance until December, but hoping there are early -- some trends both on the revenue and spending side that you can maybe call out ahead of that official guidance.

我知道你要到 12 月才會給出官方指導，但希望早點出現——收入和支出方面的一些趨勢，你可以在官方指導之前提出。

So for example, obviously, Cialis is -- will be LOE.

例如，顯然，Cialis 是 - 將是 LOE。

If I think about R&D spend, you're going to be starting Phase III trials on your GIP/GLP-1 program.

如果我考慮研發支出，您將開始 GIP/GLP-1 計劃的 III 期試驗。

So any color on '19 will be appreciated.

所以 '19 上的任何顏色都會受到讚賞。

And then a second question insulin category.

然後是第二個問題胰島素類別。

So at some point, FDA may deem biosimilar insulins as interchangeable and substitutable with brand.

因此，在某些時候，FDA 可能會認為生物仿製藥胰島素可以與品牌互換和替代。

Do you think this is more likely than not to occur?

你認為這更有可能發生嗎？

And could that be something that happens as soon as 2019?

這可能會在 2019 年發生嗎？

And if not 2019, then when?

如果不是 2019 年，那是什麼時候？

Great, Tim, good to hear your voice again.

太好了，蒂姆，很高興再次聽到你的聲音。

Welcome back.

歡迎回來。

Josh, if you'd answer the first question on the '19 tailwinds and headwinds.

喬希，如果你能回答關於 19 年順風和逆風的第一個問題。

And then, Enrique, the question Tim had on interchangeability for insulin.

然後，恩里克，蒂姆提出了關於胰島素可互換性的問題。

So Josh?

那麼喬什？

Yes.

是的。

Thanks, Tim, and you had started to answer the question.

謝謝，蒂姆，你已經開始回答這個問題了。

I think the main tailwinds -- or the headwinds that we'll see is the Cialis overhang in 2019 as we will experience the main erosion here in the fourth quarter in the U.S. So that certainly will be a headwind as we head into '19.

我認為主要的順風——或我們將看到的逆風是 2019 年的 Cialis 懸垂，因為我們將在美國第四季度經歷主要的侵蝕。所以當我們進入 19 年時，這肯定會是逆風。

With that being said, we're seeing great growth in our -- the 10 new medicines we've launched since 2014.

話雖如此，我們看到我們自 2014 年以來推出的 10 種新藥出現了巨大的增長。

So we'd expect that those -- the volume from those products to more than compensate from any of the tailwinds we've said we will see.

因此，我們希望這些產品的銷量能夠彌補我們所說的我們將看到的任何順風。

So we will see the -- a difficult compare.

所以我們將看到 - 一個困難的比較。

The other thing that we've talked about in terms of the headwind on the top line will be the change in the doughnut hole provision in Medicare Part D, the move from 50% to 70%.

我們在頂線的逆風方面談到的另一件事是醫療保險 D 部分中甜甜圈洞規定的變化，從 50% 到 70%。

And as Enrique mentioned, we've got Basaglar one of our diabetes products is in that segment strongly.

正如 Enrique 所提到的，我們的 Basaglar 糖尿病產品之一在該細分市場中表現強勁。

So we'll see a little bit of a headwind there.

所以我們會在那裡看到一點逆風。

But I think we're really pleased with the volume growth that we saw this quarter and expect that the main components of that will continue into 2019.

但我認為我們對本季度看到的銷量增長感到非常滿意，並預計其主要組成部分將持續到 2019 年。

On the R&D side, we do have a very robust set of Phase III opportunities ahead of us.

在研發方面，我們確實有一系列非常強大的第三階段機會擺在我們面前。

You mentioned tirzepatide, which we'll be starting in 2019.

您提到了 tirzepatide，我們將於 2019 年開始使用。

In a broad sense we've got mirikizumab that we've moved into Phase III.

從廣義上講，我們已經獲得了已進入第三階段的 mirikizumab。

And those trials are expensive, so we'll have costs there.

而且這些試驗很昂貴，所以我們會有成本。

And we'll see data on our ARMO asset, the IL-10, in 2019 and would expect yes, given positive data there, to continue to push that program.

我們將在 2019 年看到有關我們的 ARMO 資產 IL-10 的數據，並且預計是的，鑑於那裡的積極數據，將繼續推動該計劃。

So we'll make targeted investments in R&D and should expect to see some growth there.

因此，我們將在研發方面進行有針對性的投資，並期望在那裡看到一些增長。

I think we've been pretty clear on the SG&A line that a big component of our operating margin expansion will be to redirect the investments and resources that we have in products like Cialis and Forteo and others.

我認為我們在 SG&A 線上已經非常清楚，我們運營利潤率擴張的一個重要組成部分將是重新定向我們在 Cialis 和 Forteo 等產品中的投資和資源。

Two are new launch opportunities.

二是新的發射機會。

We'll have the -- certainly, we'll spend competitively to launch products like Emgality next year, but we'd look to manage that total base at a pretty flat level.

我們將擁有——當然，我們將有競爭力地在明年推出像 Emgality 這樣的產品，但我們希望將整個基礎管理在一個相當平坦的水平上。

All in all, we are excited about the prospects for midterm 2019 and 2020.

總而言之，我們對 2019 年中期和 2020 年的前景感到興奮。

We're well on track, we think, to meet our 2020 midterm objectives, which are 5% compound annual -- minimum 5% compound annual sales growth between 2015 and 2020; and operating margin, a minimum of 30%.

我們認為，我們有望實現 2020 年的中期目標，即 5% 的年復合增長率——2015 年至 2020 年之間至少 5% 的年復合銷售額增長；和營業利潤率，最低為 30%。

So we feel good about where we are there.

因此，我們對自己所處的位置感覺良好。

Great.

偉大的。

Thank you, Josh.

謝謝你，喬希。

Enrique?

恩里克?

When it comes to insulin interchangeability at the pharmacy level, we do not believe this is imminent.

當談到藥房層面的胰島素互換性時，我們認為這不會迫在眉睫。

At best, it's likely 50 years away, and it will require the appropriate studies for the FDA to provide such a designation.

充其量，它可能需要 50 年的時間，而且它需要 FDA 進行適當的研究才能提供這樣的指定。

Great.

偉大的。

Thank you, Enrique.

謝謝你，恩里克。

Next, we'll go to the line of Jason Gerberry with Bank of America.

接下來，我們將與美國銀行一起前往 Jason Gerberry。

Mr. Gerberry?

格伯里先生？

Shall we move on?

我們繼續前進嗎？

Yes, if you could.

是的，如果可以的話。

And next, we'll go to the line of Andrew Baum with Citi.

接下來，我們將與花旗一起前往安德魯鮑姆的路線。

A couple of questions to Enrique, please.

請向恩里克提幾個問題。

Could you talk to the barriers prohibiting broader Jardiance usage, whether it's education, the investment co-pay?

您能否談談禁止更廣泛地使用 Jardiance 的障礙，無論是教育還是投資共同支付？

And then related to that, could you outline the Tier 2 formulary stages within Medicare for Jardiance especially?

然後與此相關，您能否特別概述一下 Medicare for Jardiance 中的第 2 層處方階段？

And in particular, whether a second brand at a list -- at a net price rather than the current list price maybe helpful in increasing penetration by reducing the burden on the patients and preparing the ground for world for wells of net pricing, which seem to be potentially upon us.

特別是，第二個品牌是否以淨價而不是當前的標價可能有助於通過減輕患者負擔並為世界淨定價井做好準備來提高滲透率，這似乎可能在我們身上。

Andrew, thank you for the questions, if I got them.

安德魯，謝謝你的問題，如果我知道的話。

First, Enrique, would be barriers that you see to Jardiance usage and ways maybe to change that to formulary status in Medicare and the opportunity for a second brand to potentially address some of the issues that patients face in that book of business.

首先，Enrique，將是您看到 Jardiance 使用的障礙，以及可能將其更改為醫療保險中的處方狀態的方法，以及第二個品牌可能解決患者在該業務書中面臨的一些問題的機會。

Yes, I'm going to try to answer that question, Andrew, just a bit of color on how we see Jardiance because I do see -- there are some barriers, but I see a number of dynamics that are very positive when I look at the overall class and Jardiance in particular.

是的，安德魯，我將嘗試回答這個問題，只是對我們如何看待 Jardiance 有一點色彩，因為我確實看到了——存在一些障礙，但當我看時，我看到了一些非常積極的動態在整個班級，尤其是 Jardiance。

First, clearly, one of the things that we look at is how is the overall class evolving and developing.

首先，很明顯，我們關注的一件事是整個班級如何發展和發展。

And the class right now is growing in single digits, high single digits.

現在的班級正在以個位數、高個位數增長。

But more importantly, we're seeing new patient starts --- the growth in new patient starts accelerate.

但更重要的是，我們看到新患者開始出現——新患者開始加速增長。

We now see that in the 14%, 15% range.

我們現在看到在 14%、15% 的範圍內。

It reminds me a bit of the reacceleration of the GLP-1 class back when Trulicity was launched.

它讓我想起了 Trulicity 推出時 GLP-1 類的重新加速。

Importantly, there are new guidelines that have been published by both ADA and EASD.

重要的是，ADA 和 EASD 都發布了新的指南。

We think those guidelines are significant improvements, and that's going to be very helpful.

我們認為這些指導方針是重大改進，這將非常有幫助。

That's an important tailwind.

這是一個重要的順風。

And finally, we have improved access for Jardiance.

最後，我們改進了 Jardiance 的訪問權限。

As you know, we were excluded from one of the major accounts.

如您所知，我們被排除在主要帳戶之一之外。

We are back as of January 1, and that's going to be very important.

我們從 1 月 1 日回來，這將非常重要。

Access for Jardiance, when it comes to coverage now starting in January of '19, is in the 90s.

Jardiance 的訪問，當涉及到從 19 年 1 月開始的報導時，是在 90 年代。

So that's an excellent foundation for us to capitalize on.

因此，這是我們可以利用的絕佳基礎。

And an additional point which I emphasize in the GLP-1 class, but it's relevant for now, SGLT2s, is that we have basically additional data from competitors that are confirming the benefits when it comes to CV of the class and, importantly, investments from those competitors.

我在 GLP-1 課程中強調的另一點，但目前與 SGLT2 相關的是，我們基本上從競爭對手那裡獲得了額外的數據，這些數據證實了該課程的 CV 以及重要的是來自的投資那些競爭對手。

Jardiance is in the best opportunity to capitalize on that.

Jardiance 是利用這一點的最佳機會。

So I see an evolution.

所以我看到了進化。

And there are a lot of signs and dynamics to be hopeful about the acceleration of the overall growth and the ability for Jardiance to capitalize on that.

有很多跡象和動力對整體增長的加速以及 Jardiance 的利用能力充滿希望。

You asked about Medicare and whether we would be launching a second brand.

您詢問了醫療保險以及我們是否會推出第二個品牌。

We -- honestly, that's not where I see the issue for Jardiance when it comes to the use of it.

我們 - 老實說，在使用 Jardiance 時，我認為這不是問題所在。

Clearly, we always assess all opportunities for our brands, but we are much more focused about, I think as you implied on your question, continuing to educate doctor professionals to ensure that they understand the full benefit that Jardiance can offer patients, and these new guidelines are going to be extremely helpful to do that.

顯然，我們總是評估我們品牌的所有機會，但我認為，正如您在問題中暗示的那樣，我們更專注於繼續教育醫生專業人士，以確保他們了解 Jardiance 可以為患者提供的全部好處，以及這些新的指南將非常有助於做到這一點。

Thank you, Enrique.

謝謝你，恩里克。

Next we'll go to the line of Jason Gerberry with Bank of America.

接下來，我們將與美國銀行一起前往 Jason Gerberry。

First question is just on Taltz.

第一個問題是關於 Taltz 的。

Can you talk about the outlook going into the next few years with a new competitor launching?

你能談談隨著新競爭對手的推出而進入未來幾年的前景嗎？

And do you believe that AbbVie's market position with Humira, which has been the leading product in some of these markets, do you think that confers any advantage as it pertains to access relative to the already on market interleukin agents?

您是否認為艾伯維（AbbVie）與修美樂（Humira）在其中一些市場中的領先產品的市場地位，您認為相對於已經上市的白介素藥物而言，它是否具有任何優勢？

And then my second question, with oral GLP-1, can you talk a little about what you hope to accomplish here, especially with great data on GIP/GLP?

然後我的第二個問題，關於口服 GLP-1，你能談談你希望在這裡完成的事情嗎，尤其是在 GIP/GLP 方面的大量數據？

And as we think about Novo's oral sema, there are obviously some challenges with that product in terms of those things, so can you talk about sort of what you're looking for in terms of go, no go profile?

當我們想到 Novo 的口服 sema 時，該產品在這些方面顯然存在一些挑戰，所以你能談談你在 go, no go profile 方面尋找的東西嗎？

Great Jason, thank you for the question.

偉大的傑森，謝謝你的問題。

So Christi, if you'll take the question on the Taltz outlook going forward.

所以克里斯蒂，如果你能接受關於 Taltz 未來前景的問題。

And then over to you Dan, for our goals for the oral GLP-1 program.

然後交給你，丹，我們的口服 GLP-1 計劃目標。

Sure.

當然。

So we're very excited with Taltz.

所以我們對 Taltz 感到非常興奮。

I mean, you probably saw that our year-over-year volume growth was significant, specifically our TRx grew 80% year-over-year, and over the quarter continuing to grow the same.

我的意思是，您可能看到我們的同比銷量增長顯著，特別是我們的 TRx 同比增長 80%，並且在本季度繼續增長。

And we're just starting with Taltz.

我們剛剛從 Taltz 開始。

I mean, we have great position in the dermatology office.

我的意思是，我們在皮膚科辦公室有很好的地位。

We just launched this year in the rheumatology office with psoriatic arthritis, which that launch is going well, and it's coming off of the American College of Rheumatology.

我們今年剛剛在風濕病辦公室推出了銀屑病關節炎，該產品的推出進展順利，它來自美國風濕病學會。

We also demonstrated our data in ankylosing spondylitis, which we will submit before the end of the year, as Dave said.

正如戴夫所說，我們還展示了我們在強直性脊柱炎方面的數據，我們將在今年年底之前提交這些數據。

So as we're looking and winning in dermatology, we are beefing up in rheumatology as well.

因此，當我們在皮膚科尋找並贏得勝利時，我們也在加強風濕科。

And to your point about access, right now, our access is about the same as Cosentyx, a little bit less due to the Optum change at the beginning of the year.

至於您關於訪問權限的觀點，目前，我們的訪問權限與 Cosentyx 大致相同，由於年初 Optum 的更改，我們的訪問權限要少一些。

But with that, as you could see the growth of Taltz, it hasn't prevented us from getting patients who need help on Taltz.

但是，正如您可以看到 Taltz 的增長一樣，它並沒有阻止我們獲得需要 Taltz 幫助的患者。

And we see that continuing in the future because in this marketplace, unfortunately, patients cycle through many different therapies.

我們看到這種情況在未來還會繼續，因為不幸的是，在這個市場上，患者會循環使用許多不同的療法。

And what we are seeing from customers is that they would like a variety of therapies with different mechanisms to choose from.

我們從客戶那裡看到的是，他們希望有多種不同機制的療法可供選擇。

So you look at the entire portfolio that we have of newer agents coming out in IL-17 and IL-23, our JAK inhibitor, we're looking at being able to provide a broad portfolio to those customers, those patients and broaden our access to payers with the advent of the newer agents.

因此，您可以查看我們在 IL-17 和 IL-23（我們的 JAK 抑製劑）中推出的新型藥物的整個產品組合，我們正在尋求能夠為這些客戶、這些患者提供廣泛的產品組合併擴大我們的訪問範圍隨著新代理商的出現，付款人。

Great.

偉大的。

Thanks, Christi.

謝謝，克里斯蒂。

Dan?

擔？

Thank you for the question on our partnership with Chugai on this oral GLP-1 receptor agonist.

感謝您就我們與 Chugai 就這種口服 GLP-1 受體激動劑的合作提出問題。

This is still a pre Phase 1 molecule, but moving quickly towards human trials.

這仍然是第一階段前的分子，但正在迅速走向人體試驗。

The important comment there is that this is a non-peptic agonist.

重要的評論是這是一種非消化性激動劑。

So this is -- you should think of this very differently from an oral peptide.

所以這是 - 你應該認為這與口服肽有很大不同。

This is a small molecule approach.

這是一種小分子方法。

As such, we expect it to have in humans -- and we'll be testing a much higher bioavailability than you would see for any kind of oral peptide approach.

因此，我們預計它會在人類身上發揮作用——我們將測試比您在任何類型的口服肽方法中看到的更高的生物利用度。

What does that mean for patients?

這對患者意味著什麼？

We hope that will translate into a better experience, certainly, in terms of how and when this molecule will be dosed for the people on the trials, and ultimately in practice, but also that you translate into improved outcomes.

我們希望這將轉化為更好的體驗，當然，就如何以及何時為試驗中的人以及最終在實踐中給藥這種分子而言，而且您也可以轉化為更好的結果。

So still very early, but we're excited about the potential here and look forward to getting you updated.

所以現在還很早，但我們對這裡的潛力感到興奮，並期待為您提供最新信息。

Great.

偉大的。

Thank you, Dan.

謝謝你，丹。

Next we'll go to the line of Geoff Meacham from Barclays.

接下來我們將前往巴克萊銀行的 Geoff Meacham。

Hey guys, it's Olivia Brayer on for Geoff.

嘿，伙計們，這是傑夫的奧利維亞·布雷耶。

Thanks for taking the question.

感謝您提出問題。

Just two for me.

對我來說只有兩個。

First question is on your dual receptor agonist.

第一個問題是關於你的雙受體激動劑。

Can you provide us with any updates on the - that Phase 3 trial?

您能否向我們提供有關第三階段試驗的任何更新？

We noticed yesterday that the SURPASS trial was posted on ct.gov, so can you point to what steps you've taken to improve that overall tolerability in that Phase 3. Just curious how the design was influenced by the recently completed titration study that you previously talked about, and of course, the Phase II that we saw last month, and any expectations there on enrollment time lines?

我們昨天注意到 SURPASS 試驗已發佈在 ct.gov 上，所以您能否指出您在第 3 階段為提高總體耐受性採取了哪些步驟。只是好奇設計如何受到您最近完成的滴定研究的影響之前談到過，當然還有我們上個月看到的第二階段，以及對入學時間線的任何期望？

And then second question is just another on REWIND.

然後第二個問題只是 REWIND 上的另一個問題。

Just curious on what your view is on the incremental opportunity here.

只是好奇你對這裡的增量機會的看法。

Any thoughts on how it might change the treatment paradigm?

關於它如何改變治療範式的任何想法？

And what the impact on overall GLP-1 class might be?

對整個 GLP-1 類的影響可能是什麼？

Great.

偉大的。

Thank you for the question.

感謝你的提問。

So Enrique, we will have you attack those.

所以恩里克，我們會讓你攻擊那些。

So the first one on GIP/GLP or tirzepatide, things are being done for Phase III with titration, things we learned in our Phase II program and any comments on enrollment timing, and then how you see REWIND playing out going forward to GLP-1 market.

所以第一個關於 GIP/GLP 或 tirzepatide 的事情正在為 III 期做滴定，我們在 II 期項目中學到的東西以及關於註冊時間的任何評論，然後你如何看待 REWIND 在 GLP-1 中的表現市場。

So as we've shared as part of tirzepatide's Phase III program, we are planning to study 3 maintenance doses: 5, 10 and 15 milligrams.

因此，正如我們在 tirzepatide 的 III 期計劃中所分享的那樣，我們計劃研究 3 種維持劑量：5、10 和 15 毫克。

I think what we've learned is that we should titrate in smaller increments and over time.

我認為我們學到的是，我們應該隨著時間的推移以更小的增量進行滴定。

As we've shared, we have a titration study that we intend to share the details next year, but clearly we have learned a lot from that study in terms of what are the optimum titration schedules.

正如我們所分享的，我們有一項滴定研究，我們打算在明年分享詳細信息，但顯然我們從該研究中學到了很多關於最佳滴定時間表的知識。

We are planning aggressively when it comes to start of this trial and starting enrollment.

我們正在積極計劃開始這項試驗和開始註冊。

So you'll be hearing more when it comes to our trial for type 2 diabetes soon.

因此，當談到我們的 2 型糖尿病試驗時，您很快就會聽到更多消息。

As far as REWIND, I don't want to speculate on the particular indication that we will get, but clearly, this is important for the class in that it confirms what other GLP-1s have shown when it comes to seeing benefit.

至於 REWIND，我不想推測我們將獲得的特定跡象，但很明顯，這對班級很重要，因為它證實了其他 GLP-1 在看到好處時所顯示的內容。

And I'm sorry, I cannot resist but I heard the Novo Nordisk call, and they also mentioned that GLP-1s were not all the same.

對不起，我無法抗拒，但我聽到了 Novo Nordisk 的電話，他們還提到 GLP-1 並不完全相同。

And I think we agree with them.

我認為我們同意他們的觀點。

Thank you, Enrique.

謝謝你，恩里克。

And next, we'll go to the line of Steve Scala with Cowen.

接下來，我們將與 Cowen 一起前往 Steve Scala。

I have a couple of questions.

我有一些問題。

You mentioned the U.S. price hit from gaining access for Basaglar, Taltz and Humalog, but was there one-time volume gain from this reflected in the 17% U.S. volume increase?

您提到了 Basaglar、Taltz 和 Humalog 獲得准入權對美國價格造成的打擊，但是這是否反映了美國 17% 的銷量增長中的一次性銷量增長？

So that's the first question.

所以這是第一個問題。

The second question is to go back to the questions on REWIND.

第二個問題是回到 REWIND 上的問題。

Is REWIND precedent-setting because of the population studied?

REWIND 是否因為所研究的人群而開創先例？

Or is it precedent-setting because you have avoided the less-than-optimal outcomes of Novo's LEADER and SUSTAIN 6?

還是因為您避免了 Novo 的 LEADER 和 SUSTAIN 6 的不太理想的結果而開創了先例？

Or perhaps both?

或者兩者兼而有之？

And the precedent-setting is a big statement.

開創先例是一個重要的聲明。

So in the absence of any color, I guess, we have to assume you hit all 3 components of the primary endpoint, which is something Novo was not able to accomplish?

所以在沒有任何顏色的情況下，我猜，我們必須假設您達到了主要終點的所有 3 個組件，這是 Novo 無法完成的事情？

Great, Steve.

太好了，史蒂夫。

Thank you for the questions.

謝謝你的提問。

So Josh, if you'll take the comment on the U.S. price, so there's also seeing some offsets there in the volumes that we're gaining.

所以喬希，如果你對美國的價格發表評論，那麼我們獲得的數量也會出現一些抵消。

And then Enrique, on what we mean by precedent-setting for REWIND?

然後是 Enrique，我們所說的 REWIND 的先例設置是什麼意思？

Thanks, Steve.

謝謝，史蒂夫。

Yes, if you look at volume for the third quarter in the U.S., it grew at 17%, which Dave and I both mentioned was the most significant volume growth we've seen this decade.

是的，如果你看一下美國第三季度的銷量，它增長了 17%，戴夫和我都提到這是我們十年來看到的最顯著的銷量增長。

And that Basaglar absolutely contributed to that growth.

Basaglar 絕對促成了這種增長。

So the access that we got in Medicare Part D is contributing to the 17% growth, as are the other elements that we mentioned around patient access and all of the new launches.

因此，我們在醫療保險 D 部分中獲得的訪問權推動了 17% 的增長，我們提到的圍繞患者訪問權和所有新推出的其他要素也是如此。

So it is a positive offset there.

所以這是一個正偏移量。

You can see in total, even with that negative 6% growth, U.S. business grew 11% overall.

你可以看到，即使出現 6% 的負增長，美國的業務總體增長了 11%。

Okay.

好的。

Thanks, Josh.

謝謝，喬希。

Enrique?

恩里克?

As I mentioned, when I first discussed REWIND as part of the first question, it is precedent-setting because it includes some enrollment of patients without cardiovascular disease.

正如我所提到的，當我第一次討論 REWIND 作為第一個問題的一部分時，這是一個先例，因為它包括了一些沒有心血管疾病的患者。

It has the longest median follow-up and a low A1c baseline.

它具有最長的中位隨訪時間和較低的 A1c 基線。

We'll be sharing the detailed results at the ADA next year.

我們將在明年的 ADA 上分享詳細結果。

Thank you, Enrique.

謝謝你，恩里克。

Next, we'll go to the line of Umer Raffat with Evercore.

接下來，我們將與 Evercore 一起前往 Umer Raffat 的路線。

First, maybe on the oncology side.

首先，也許是在腫瘤學方面。

I noticed for your IL-10, you have decent monotherapy activity in the renal cell setting, but the randomized trials you're running are long and pancreatic, but just wanted to get the thought process there.

我注意到您的 IL-10 在腎細胞環境中具有不錯的單藥治療活性，但是您正在進行的隨機試驗很長而且很棘手，但只是想在那裡進行思考。

Is that a consideration?

這是一個考慮嗎？

And also your confidence on those open labeled lung trials that are coming off on first half '19.

還有你對那些在 19 年上半年開始的開放標籤肺試驗的信心。

Second, on NGF, it seems like the placebo adjusted efficacy definitely faded into the latest readout?

其次，在 NGF 上，似乎安慰劑調整的療效肯定會消失在最新的讀數中？

And my question is, do you look at this current placebo adjusted efficacy from this latest trial as being clinically meaningful?

我的問題是，你認為這項最新試驗中目前的安慰劑調整療效是否具有臨床意義？

And also just your thoughts on the joint replacements on that trial.

還有你對那次試驗中關節置換的想法。

Great, Umer.

太好了，烏默爾。

Thank you for the questions.

謝謝你的提問。

So Dan, we'll go to you for those on the development strategy for the IL-10, and then also what we think about the efficacy results and any safety findings from the initial trials read out for our NGF.

因此，丹，我們將向您介紹 IL-10 的開發策略，以及我們對 NGF 初步試驗的療效結果和任何安全性結果的看法。

Thanks, Umer, for those good questions.

謝謝，Umer，這些好問題。

So starting with the pegilodecakin candidate, IL-10.

因此，從 pegilodecakin 候選藥物 IL-10 開始。

As you point out, the randomized trial that's ongoing in Phase III is in pancreas.

正如你所指出的，正在進行的 III 期隨機試驗是在胰腺中進行的。

We're excited about that and look forward to seeing data there in combination with FOLFOX.

我們對此感到興奮，並期待看到與 FOLFOX 相結合的數據。

The 2 Phase II studies that you mentioned are randomized trials in non-small cell lung cancer.

您提到的 2 項 II 期研究是非小細胞肺癌的隨機試驗。

The first one is in the first line setting in PD-L1 high patients and the second one is in the second line setting in the PD-L1 low setting, both in combination with IO.

第一個是在 PD-L1 高患者的第一線設置，第二個是在 PD-L1 低設置的第二線設置，兩者都與 IO 結合使用。

We are absolutely excited to see data from those trials starting next year, which will inform our progress in that opportunity.

我們非常高興看到從明年開始的這些試驗的數據，這將為我們在這個機會中取得進展提供信息。

As for RCC, you're right that we had the monotherapy activity there in that early Phase I study, which was exciting and part of the basis of the bet here is that this molecule is active in the monotherapy setting.

至於 RCC，您說得對，我們在早期的 I 期研究中進行了單藥治療，這是令人興奮的，這裡打賭的部分基礎是這種分子在單藥治療環境中是有活性的。

I think in terms of that indication, other indications, we're still working through what our plan is.

我認為就該跡象和其他跡象而言，我們仍在研究我們的計劃。

Some of that will depend on data that we get in these next couple of trials as well as the data that we already have.

其中一些將取決於我們在接下來的幾次試驗中獲得的數據以及我們已經擁有的數據。

We hope to be able to share more with you about our plans for that molecule at our December R&D Day.

我們希望能夠在 12 月的研發日與您分享更多關於我們對該分子的計劃。

With respect to tanezumab, I think you had a question there on both the efficacy and the safety with respect to total joint replacements.

關於 tanezumab，我認為您對全關節置換的有效性和安全性有疑問。

On the efficacy, it's hard to make cross-trial comparisons.

在療效上，很難進行交叉試驗比較。

Of course, this is a different population, so they're more treatment resistant, more severe population than in those prior studies.

當然，這是一個不同的人群，所以他們比之前的研究更具抗藥性，更嚴重的人群。

Still, on balance, the efficacy looks quite comparable to what we would expect, maybe some small differences in placebo group from trial to trial.

儘管如此，總的來說，療效看起來與我們預期的相當，也許安慰劑組在試驗與試驗之間存在一些小的差異。

This is a small trial and we look forward to the full results coming.

這是一個小試驗，我們期待著完整的結果。

But all in all, I would say the efficacy data are where we expect them to be.

但總而言之，我會說功效數據是我們所期望的。

And we're really, I think, excited, as we said before, about the potential of this molecule from an efficacy perspective.

正如我們之前所說，從功效的角度來看，我們真的對這種分子的潛力感到興奮。

The question, of course, is can we adequately discharge the safety risk?

當然，問題是我們能否充分消除安全風險？

So the total joint replacement, there was an imbalance in this small study, we don't fully understand what drove that imbalance.

所以全關節置換，在這項小型研究中存在不平衡，我們不完全了解是什麼導致了這種不平衡。

I think there were a number of factors that we noticed about the imbalance in total joint replacements.

我認為我們注意到了許多關於關節置換總量不平衡的因素。

One was that most of these events occurred in the follow-up period rather than the on treatment period.

一是這些事件大多發生在隨訪期而不是治療期。

Another observation is that these events were generally in the patients who are most severe at enrollment.

另一個觀察結果是，這些事件通常發生在入組時最嚴重的患者身上。

It was in their index joints and it was not, in general -- in most cases, it was not associated with any adverse event or any finding in the joint adjudication.

它出現在他們的食指關節中，一般來說，它不是——在大多數情況下，它與任何不良事件或聯合裁決中的任何發現無關。

So we'll keep our eye on that.

所以我們會密切關注這一點。

And of course, the big readout for us with our partners, Pfizer, will be next year when we get that large 56-week study.

當然，我們與合作夥伴輝瑞（Pfizer）的重大成果將是明年我們進行為期 56 週的大型研究時。

Thank you, Dan.

謝謝你，丹。

Certainly.

當然。

Next is Alex Arfaei with BMO capital.

接下來是 BMO 資本的 Alex Arfaei。

First, on REWIND.

首先，在 REWIND 上。

Enrique, 2019 seems like a long time to wait for the result.

恩里克，2019 年似乎等待結果的時間很長。

You mentioned you plan to file indication for 2019, so when should we expect to see it in the Trulicity label?

您提到您計劃在 2019 年提交指示，那麼我們應該什麼時候在 Trulicity 標籤中看到它？

And then I have a couple of questions on Verzenio, please.

然後我有幾個關於 Verzenio 的問題。

The market seems to have slowed down more than we expected.

市場放緩的幅度似乎超出了我們的預期。

Just wondering if you could give us your thoughts there.

只是想知道你是否可以在那裡給我們你的想法。

You are gaining share, which is great, but what's going on with the overall market?

您正在獲得份額，這很好，但整體市場情況如何？

And we noticed you moved up the time line for the adjuvant study by 1 year on clinical trial.

我們注意到您在臨床試驗中將輔助研究的時間線提前了 1 年。

Just wondering if you changed anything about the trial?

只是想知道你是否改變了審判的任何內容？

Or is it just your expectations about based on the powering of the study or expected benefit?

還是只是您對研究的動力或預期收益的期望？

Great.

偉大的。

Thank you for the questions, Alex.

謝謝你的問題，亞歷克斯。

So timing for a potential label update on REWIND, Enrique, for you?

那麼，恩里克對 REWIND 進行潛在的標籤更新的時機對你來說是什麼？

And then Anne, if you'd like to handle what we're seeing for market growth with CDK4/6 class and change in timing on clinicaltrials.gov for the adjuvant study.

然後是安妮，如果您想處理我們所看到的 CDK4/6 類市場增長和臨床試驗.gov 上輔助研究的時間變化。

Enrique?

恩里克?

Well, clearly, we're planning to pursue an indication under a submission in 2019 and standard review.

好吧，很明顯，我們計劃在 2019 年提交的文件和標準審查中尋求指示。

We will be looking at a label update in 2020.

我們將關注 2020 年的標籤更新。

Of course, we are working as fast as we can to try to expedite that as much as possible.

當然，我們正在盡可能快地工作，以盡可能加快這一進程。

I will be working with the regulatory authorities.

我將與監管機構合作。

Unfortunately, we won't be able to share the REWIND data prior to ADA.

不幸的是，我們將無法在 ADA 之前共享 REWIND 數據。

Thank you, Enrique.

謝謝你，恩里克。

Anne?

安妮？

Thanks for the question on Verzenio.

感謝您對 Verzenio 提出的問題。

We have seen some slowing on the growth of CDK4/6 market as others in the class have commented.

正如班上其他人所評論的那樣，我們已經看到 CDK4/6 市場的增長有所放緩。

However, we do still see potential growth as more physicians trial this class, particularly as they trial Verzenio.

然而，隨著越來越多的醫生試用該課程，我們仍然看到潛在的增長，特別是當他們試用 Verzenio 時。

So as you mentioned, our NBRx rate is in the high teens, and we continue to be pleased with this growth.

因此，正如您所提到的，我們的 NBRx 率處於十幾歲，我們繼續對這種增長感到滿意。

And we are encouraged by a couple of specific factors.

我們受到一些具體因素的鼓舞。

So first, as we continue to drive trials with Verzenio in the U.S., what we're seeing is a win position, trial Verzenio, they have a really good experience and they're likely to prescribe again, so becoming adopters.

因此，首先，當我們繼續在美國推動 Verzenio 的試驗時，我們看到的是一個勝利的位置，試驗 Verzenio，他們有一個非常好的經驗，他們可能會再次開處方，所以成為採用者。

What seems to particularly resonate with physicians is the fact that patients with certain concerning clinical characteristics that indicate a poor prognosis, do well on Verzenio.

似乎與醫生產生特別共鳴的是，具有某些臨床特徵表明預後不良的患者在 Verzenio 上表現良好。

So these are patients with liver metastases, the high tumor grade visceral disease or cancer that's not confined to the bone.

因此，這些患者患有肝轉移、腫瘤級別高的內臟疾病或不局限於骨骼的癌症。

And so we'll be publishing that additional data shortly.

所以我們很快就會發布這些額外的數據。

We're also very enthusiastic about the fact that we received approval in Japan and in Europe, so we see those markets as significant growth drivers.

我們也非常高興我們在日本和歐洲獲得批准，因此我們將這些市場視為重要的增長動力。

And then third, related to your question around adjuvant, we do see potential future opportunity in the broader breast cancer market following read-outs in the HER2-positive population, our OS readout from the MONARCH 2 study.

第三，與您關於輔助治療的問題相關，我們確實看到了在更廣泛的乳腺癌市場中潛在的未來機會，這是我們從 MONARCH 2 研究中讀出的 HER2 陽性人群的讀數。

And then very importantly, the work, as you said, in Adjuvant breast cancer.

然後非常重要的是，正如你所說，在輔助乳腺癌中的工作。

On Adjuvant specifically, what we're seeing is that study is enrolling very well.

特別是在 Adjuvant 上，我們看到的是這項研究的招生情況非常好。

It's more than 60% enrolled, so we're quite encouraged by that time line.

它的註冊率超過 60%，所以我們對這個時間線感到非常鼓舞。

So we do expect results in 2021 and we look forward to that market because as you know, Adjuvant is really twice the size of the metastatic breast cancer market, so a significant growth opportunity for Lilly in the future.

因此，我們確實期待 2021 年的結果，我們期待這個市場，因為如您所知，Adjuvant 的規模實際上是轉移性乳腺癌市場的兩倍，因此未來對禮來公司來說是一個重要的增長機會。

Thank you, Anne.

謝謝你，安妮。

Next will be David Risinger with Morgan Stanley.

接下來是摩根士丹利的 David Risinger。

So Lilly's volume growth has been and is set to continue to be very strong.

因此禮來公司的銷量增長已經並將繼續保持強勁勢頭。

But could you please comment on 3 quick questions on pricing.

但是，您能否對有關定價的 3 個快速問題發表評論。

First, the list price outlook for 2019 that you have in your planning assumptions.

首先，您在計劃假設中的 2019 年標價展望。

Second, your exposure to a step up in the donut hole fill in 2019.

其次，您在 2019 年的甜甜圈洞填充中會有所提升。

And third, your exposure to growth in copay accumulators in 2019.

第三，您對 2019 年共付額累加器增長的敞口。

Great, Dave.

太好了，戴夫。

Thank you for the questions.

謝謝你的提問。

Josh, if you'd like to answer those questions on expectations moving forward on price.

喬希，如果你想回答這些關於價格預期的問題。

So Dave, we'll do our guidance for 2019 in December and we'll provide our pricing assumption.

所以戴夫，我們將在 12 月為 2019 年提供指導，我們將提供我們的定價假設。

Then I can tell you for 2018, for the guidance that we gave, we're not assuming any additional price increases this year.

然後我可以告訴你 2018 年，對於我們給出的指導，我們假設今年不會有任何額外的價格上漲。

In terms of exposure to the change in the donut hole provision, we've said before that we look across our portfolio.

就甜甜圈洞規定的變化而言，我們之前已經說過，我們會審視我們的投資組合。

It's about $200 million of incremental impact in 2019.

2019 年的增量影響約為 2 億美元。

And then on the copay accumulators piece, of course, these impact specialty drugs, particularly Taltz and Forteo for now, and at least for where we are right now, we're comfortable that there is not a significant exposure here.

然後在共付額累加器部分，當然，這些影響特殊藥物，特別是目前的 Taltz 和 Forteo，至少就我們現在的情況而言，我們很滿意這裡沒有顯著的曝光。

Just maybe a follow-on comment on that.

可能只是對此的後續評論。

I have seen notes from analysts, as well as other industry commentators, that roughly, and especially segments, these are single-digit impacts in terms of patients actually exposed to the out-of-pocket cost of copay accumulators, net of industry actions and payer actions, and that's not really different for us with Taltz, which is the major product affected.

我從分析師和其他行業評論員那裡看到，大致上，尤其是細分市場，這些都是個位數的影響，就實際暴露於共付累加器自付費用的患者而言，扣除行業行動和付款人的行為，這對我們來說與 Taltz 並沒有什麼不同，這是受影響的主要產品。

So it's an issue, but it's not a huge driver of the overall picture.

所以這是一個問題，但它不是整體情況的巨大驅動力。

Great.

偉大的。

Thanks, Dave.

謝謝，戴夫。

And it will be Vamil Divan with Crédit Suisse.

這將是瑞士信貸的 Vamil Divan。

So one, just on Olumiant.

所以一個，就在Olumiant上。

Looks like still pretty good European uptake, but sort of limited uptake in the first few months on the market in the U.S. So maybe you can just talk about sort of access and sort of initial physician interest in that product.

看起來歐洲的吸收率仍然很高，但在美國市場上的前幾個月吸收率有限。所以也許你可以談談某種訪問和最初醫生對該產品的興趣。

And then the other one is maybe a little bit of a different product we don't talk much about is Lartruvo.

然後另一個可能是我們很少談論的不同產品，即Lartruvo。

It's still one of your newer medications, but I think it's asked about a little less.

它仍然是您的較新藥物之一，但我認為它被問到的要少一些。

I'm just trying to get a better sense of that market.

我只是想更好地了解這個市場。

I mean, the growth is still there in the U.S. but slowing a little bit, and I'm just trying to get a better sense of how penetrated you think that product is into that market and maybe a little bit more on the longer-term potential for that one?

我的意思是，美國的增長仍然存在，但略有放緩，我只是想更好地了解您認為該產品在該市場的滲透程度，從長遠來看可能會更多那個潛力？

Great, Vamil.

太好了，瓦米爾。

Thank you for the question.

感謝你的提問。

So Christi, if you'd like to talk about what we're seeing in terms of uptake access and clinician, physician experience here in the U.S. And then Anne, over to you for what we're seeing with Lartruvo and the market opportunity there.

所以克里斯蒂，如果你想談談我們在美國的吸收訪問和臨床醫生、醫生經驗方面所看到的情況，然後是安妮，請談談我們在拉特魯沃看到的情況以及那裡的市場機會.

Sure.

當然。

So thank you for the questions, Vamil.

所以謝謝你的問題，瓦米爾。

In terms of Olumiant, I will start with the EU, as you suggested, outside of the U.S. The growth of Olumiant in volume in Europe in the last 2 quarters has actually been the fastest growing in volume for Lilly as a whole.

就 Olumiant 而言，正如您所建議的，我將從歐盟開始，在美國以外的地區。過去兩個季度，Olumiant 在歐洲的銷量增長實際上是禮來（Lilly）整體銷量增長最快的。

And in Japan, we just -- we're lifted in September on the 2-week restriction, so we seeing significant uptake now that, that restriction is off.

在日本，我們剛剛在 9 月取消了為期 2 週的限制，所以我們現在看到了顯著的吸收，該限制已經取消。

And in the U.S., we are getting a lot of usage in terms of the uptake.

在美國，我們在吸收方面得到了很多使用。

We are giving samples in the office to physician so you won't see that in the uptake.

我們正在辦公室將樣本提供給醫生，因此您不會在吸收中看到這一點。

But more importantly, what we're hearing from physicians is that their patients are having really positive feedback on our speed of onset just like we saw in Europe and the other 50 countries where we've launched, the efficacy continues to deliver and really helping patients with that early onset of symptom relief so they can get back to the productive days of life which is significant.

但更重要的是，我們從醫生那裡聽到的是，他們的患者對我們的發病速度有非常積極的反饋，就像我們在歐洲和我們推出的其他 50 個國家看到的那樣，療效繼續發揮並真正有幫助早期症狀緩解的患者，這樣他們就可以回到生活中富有成效的日子，這很重要。

And as the physicians see those patients come back, it truly is changing and then helps them, obviously, feel more comfortable in prescribing as well.

當醫生看到這些病人回來時，情況確實在發生變化，然後顯然也幫助他們在開處方時感覺更舒服。

And Olumiant is really key for us.

而 Olumiant 對我們來說真的很關鍵。

It's not just in the U.S. RA, but we continue to evolve the indications for Olumiant.

不僅在美國 RA，我們還在繼續發展 Olumiant 的適應症。

We have 3 Phase III studies, obviously, that we're recruiting for in atopic dermatitis, in lupus and a Phase II/III adaptive study in alopecia areata.

顯然，我們有 3 項 III 期研究，我們正在招募針對特應性皮炎、狼瘡和斑禿的 II/III 期適應性研究。

So as those readouts come out as well, we'll be looking for significant uptake of Olumiant in helping a lot of patients with high unmet need.

因此，隨著這些讀數的出現，我們將尋找 Oluminant 的大量使用，以幫助許多有高度未滿足需求的患者。

Thank you, Christi.

謝謝你，克里斯蒂。

Anne?

安妮？

So we are pleased with the uptake on Lartruvo, and it has been steadily increasing since launch.

因此，我們對 Lartruvo 的使用感到滿意，並且自推出以來一直在穩步增長。

So as you saw the year-to-date, so we've had a 54% increase over last year and just a 41% increase in this quarter.

因此，正如您看到的年初至今，我們比去年增長了 54%，而本季度僅增長了 41%。

And Lartruvo is the market leader now in the U.S. in first-line metastatic soft tissue sarcoma, it has about a 20% market share.

Lartruvo 是目前美國一線轉移性軟組織肉瘤的市場領導者，市場份額約為 20%。

And then we were excited to see that it is now the market leader in the dox-eligible patients, passing dox optimized this year at a 36% share of market.

然後我們很高興地看到它現在是符合 dox 條件的患者的市場領導者，在今年以 36% 的市場份額超過了 dox 優化。

And as you know well, it remains the only medicine in 4 decades that actually helps patients live longer when compared to dox alone.

如您所知，與單獨使用 dox 相比，它仍然是 4 年來唯一真正幫助患者活得更長的藥物。

So we're also encouraged by the fact that we are seeing thought leaders fairly routinely refer to it as the standard of care and growth in our topic particularly is very strong.

因此，我們看到思想領袖經常提到它，因為我們的主題中的關懷和成長標準非常強大，這也讓我們感到鼓舞。

In fact, 97% of the top 100 institutions have now posted sales since launch of Lartruvo.

事實上，自 Lartruvo 推出以來，前 100 家機構中有 97% 已經公佈了銷售額。

We are still seeing launch in Europe and still gaining access, so we still think there's potential for growth obviously in that market.

我們仍然看到在歐洲推出並仍在獲得准入，因此我們仍然認為該市場具有明顯的增長潛力。

Our major focus really is on driving awareness in the community and in the centers of excellence where a lot of these key treatment decisions are made.

我們的主要重點實際上是提高社區和做出許多關鍵治療決定的卓越中心的意識。

So we do feel -- still see quite a bit of potential for growth for Lartruvo, but I will acknowledge it's an orphan disease population.

所以我們確實覺得——仍然看到拉特魯沃有相當大的增長潛力，但我承認這是一個孤兒疾病人群。

And so at one point we will see penetration, but we don't see that yet.

所以在某一時刻，我們會看到滲透，但我們還沒有看到。

We still see a good potential growth and are pleased on how we're doing.

我們仍然看到良好的潛在增長，並對我們的表現感到高興。

Great.

偉大的。

Thank you, Anne.

謝謝你，安妮。

It will be Louise Chen with Cantor Fitzgerald.

將是路易斯·陳和康托·菲茨杰拉德。

So my first question is on REWIND.

所以我的第一個問題是關於 REWIND。

Has this met your internal expectation for relative risk reduction?

這是否符合您對降低相對風險的內部期望？

And have you historically talked about what kind of incremental sales opportunity it can mean for you?

您是否曾經談論過它對您意味著什麼樣的增量銷售機會？

And then secondly, on the injectable CGRPs, how do you see this market landscape playing out with 3 approved products and more to come on the injectable and oral side?

其次，關於注射用 CGRP，您如何看待隨著 3 種獲批產品以及更多注射劑和口服產品出現的市場格局？

Do you think it will grow the entire market?

你認為它會擴大整個市場嗎？

Or take share from existing products?

還是從現有產品中分一杯羹？

Great, Louise, thank you for the questions.

太好了，路易絲，謝謝你的提問。

So Enrique, another question on REWIND for you.

所以恩里克，關於 REWIND 的另一個問題。

And then Christi, on the CGRP question, please.

然後克里斯蒂，請談談 CGRP 問題。

Well, on the expectations, of course, this is a positive trial.

好吧，當然，這是一個積極的嘗試。

Trulicity showing superiority in a broad range of patients with type 2 diabetes.

Trulicity 在廣泛的 2 型糖尿病患者中顯示出優越性。

Thank you.

謝謝你。

Christi?

克里斯蒂?

Yes, so we are actually extremely excited about the migraine marketplace.

是的，所以我們實際上對偏頭痛市場感到非常興奮。

I mean, you're seeing, as we've been discussing over the last year, the high unmet need with now tens of thousands of patients already being prescribed a preventive now.

我的意思是，正如我們在過去一年中一直在討論的那樣，您看到了高度未滿足的需求，現在已經有成千上萬的患者被開出預防性處方。

And we're -- I don't think I have talked to you since we actually received our label, so we're really happy with the label received in terms of our differentiation.

而且我們 - 自從我們真正收到我們的標籤以來，我想我沒有和你談過，所以我們對收到的標籤在我們的差異化方面非常滿意。

We have the 50%, 75% and 100% migraine-free data that we are able to promote.

我們擁有能夠推廣的 50%、75% 和 100% 無偏頭痛的數據。

Also our positive outcomes for functional measures, which is unique for Emgality, is in the label.

我們對 Emgality 獨有的功能措施的積極成果也在標籤中。

And we just presented data at the American Headache Society that Emgality works fast.

我們剛剛在美國頭痛協會提供了 Emgality 工作速度很快的數據。

Our induction dose is so that patients can actually get the medication quickly and get it in the doctor's office where they teach them how to do the autoinjector, they should do it themselves and then they go and take it once-a-month then on.

我們的誘導劑量是為了讓患者實際上可以快速獲得藥物並在醫生辦公室獲得藥物，在那裡他們教他們如何使用自動注射器，他們應該自己做，然後他們每個月服用一次。

Lastly, the other differentiation is we got the breakthrough therapy designation in cluster, and we're very excited about that for patients who have had no treatment, no approved treatment in that suicide headache population.

最後，另一個區別是我們在集群中獲得了突破性治療指定，對於那些在自殺性頭痛人群中沒有接受過治療、沒有批准治療的患者，我們對此感到非常興奮。

So as we look at the marketplace, we see it continuing to grow.

因此，當我們觀察市場時，我們看到它繼續增長。

We like our chances in terms of being able to compete, and with the competitive agents and oral agents coming out next year, those right now, are in a different class that will compete with lasmiditan and not be preventative therapies initially.

我們喜歡我們能夠競爭的機會，並且隨著明年出現的競爭性藥物和口服藥物，現在這些藥物屬於不同的類別，將與 lasmiditan 競爭，而不是最初的預防性治療。

So with the entire franchise we have in migraine in both preventative and acute, we think we are a leader and we know we're a leader in pain and migraine, and we'll continue to prove it out over time.

因此，憑藉我們在預防性和急性偏頭痛方面的整個特許經營權，我們認為我們是領導者，我們知道我們是疼痛和偏頭痛方面的領導者，隨著時間的推移，我們將繼續證明這一點。

Great.

偉大的。

Thank you, Christi.

謝謝你，克里斯蒂。

And next, we'll go to the line of Seamus Fernandez with Guggenheim Securities.

接下來，我們將與古根海姆證券一起前往 Seamus Fernandez。

So just a couple.

所以只是一對。

Can you help us understand a little bit the opportunity for Emgality in cluster headache specifically?

你能幫我們了解一下 Emgality 在叢集性頭痛中的機會嗎？

Is this a new large new patient population that we should be thinking about?

這是我們應該考慮的新的大量新患者群體嗎？

Or is it more an indication that will firm up your and differentiate your market position?

還是更多的跡象表明您將鞏固和區分您的市場地位？

And then second, Enrique, can you talk more about the international growth opportunity for the GLP-1 class overall?

然後第二個，Enrique，你能談談 GLP-1 類整體的國際增長機會嗎？

When I look at the class, we're looking at about 1/3 of sales relative to the U.S., and frankly, when we look at other large classes, the opportunities seems to be like it would be quite a bit greater and I just would love to know what you see as the opportunity internationally or perhaps what the holdbacks are?

當我查看班級時，我們看到的銷售額約為美國銷售額的 1/3，坦率地說，當我們查看其他大型班級時，機會似乎會更大一些，而我只是想知道您認為國際上的機會是什麼，或者阻礙是什麼？

Great, Seamus, thank you for the questions.

太好了，Seamus，謝謝你的提問。

Welcome back to you as well.

也歡迎您回來。

Good to hear your voice on the line.

很高興聽到您在線上的聲音。

Christi, if you'll take the question on the opportunity for cluster for Emgality.

克里斯蒂，如果你會回答關於 Emgality 集群機會的問題。

And then Enrique, for the international growth opportunity for GLP1 class.

然後是恩里克，為 GLP1 課程的國際增長機會。

Thank you, Seamus, for the question.

謝謝你，Seamus，你的問題。

As I said, earlier, we are so excited to help these patients with cluster.

正如我之前所說，我們很高興能幫助這些患有集群的患者。

And although the number of patients who have clusters obviously significantly less than the general moderate to severe migraine population, it is such a high unmet need that we are privileged to provide that for patients.

儘管有集群的患者數量明顯少於一般的中度至重度偏頭痛人群，但我們有幸為患者提供如此高的未滿足需求。

And the second part of your question, I think it is good for that but it's also obviously confirming, again, the efficacy of Emgality.

你問題的第二部分，我認為這有好處，但它也顯然再次證實了 Emgality 的功效。

As I stated before, Emgality is the only one who actually demonstrated efficacy in 100% of being able to relieve 100% of migraines in any given month.

正如我之前所說，Emgality 是唯一一個在任何給定月份中真正表現出 100% 能夠緩解 100% 偏頭痛的功效。

And that efficacy, now coupled with cluster, which is significant, no one has ever showed efficacy, that halo effect across Emgality and migraine we expect will be a benefit.

而且這種功效，現在加上集群，這是顯著的，沒有人表現出功效，我們期望的 Emgality 和偏頭痛的光環效應將是一個好處。

Thank you, Christi.

謝謝你，克里斯蒂。

Enrique?

恩里克?

So there is a significant opportunity just like in the U.S., outside of the U.S. for the GLP-1 class.

因此，就像在美國一樣，在美國以外的 GLP-1 課程有一個重要的機會。

The GLP-1 class is growing in the mid-20s outside of the U.S. in most markets.

在美國以外的大多數市場，GLP-1 類在 20 年代中期正在增長。

So very healthy growth.

所以非常健康的成長。

Something unique when we look at the addressable market is the size of the basic insulin market, which as we know represents a significant opportunity as we see GLP-1 being the injectables of choice first injectables prior to basal insulin.

當我們看到潛在市場時，獨特之處在於基礎胰島素市場的規模，正如我們所知，這代表了一個重要的機會，因為我們認為 GLP-1 是首選注射劑，先於基礎胰島素。

So very significant opportunity, but we see that playing out over time.

所以非常重要的機會，但我們看到隨著時間的推移會發揮作用。

Thank you, Enrique.

謝謝你，恩里克。

I appreciate it.

我很感激。

It will be Steve Scala with Cowen.

將是史蒂夫·斯卡拉（Steve Scala）和考恩（Cowen）。

A couple of questions.

幾個問題。

Regarding dropping the N3pG plus BACE in Alzheimer's disease.

關於在阿爾茨海默病中放棄 N3pG 加 BACE。

The early data was great, so what was the reason for dropping the product?

早期的數據很好，那麼下架的原因是什麼？

And it was mentioned that monotherapy continues, but I thought the monotherapy was discontinued earlier this year?

有人提到單藥治療仍在繼續，但我認為單藥治療今年早些時候停止了？

Or has the monotherapy restarted?

還是重新開始單藥治療？

So that's the first question.

所以這是第一個問題。

Second question is on Jardiance.

第二個問題是關於 Jardiance 的。

Why are you not filing for type 1 diabetes as an insulin adjunct in 2018 given the positive data?

鑑於積極的數據，您為什麼不在 2018 年申請 1 型糖尿病作為胰島素輔助治療？

I think that had been the expectation that you would file this year.

我認為這是您今年提交申請的期望。

Steve, thank you for the questions.

史蒂夫，謝謝你的提問。

Dan, if you'd like to answer where we are with the N3pG and BACE combo and N3pG more broadly.

Dan，如果您想回答我們在 N3pG 和 BACE 組合以及更廣泛的 N3pG 方面的情況。

And then Enrique, if you would like to take the type 1 filing question.

然後是 Enrique，如果您想回答第 1 類歸檔問題。

Dan?

擔？

Thanks, Steve.

謝謝，史蒂夫。

Sorry for the confusion there.

很抱歉那裡的混亂。

So on the N3pG BACE, we've dropped the BACE arm of this trial, so N3pG does continue.

因此，在 N3pG BACE 上，我們放棄了該試驗的 BACE 分支，因此 N3pG 確實繼續。

The decision to drop BACE is based on a couple of factors.

放棄 BACE 的決定基於幾個因素。

One was what we have seen across the field with various BACE inhibitors where these drugged don't have a benefit, they actually cause some increased rate of cognitive worsening.

一個是我們在整個領域看到的各種 BACE 抑製劑，這些藥物沒有任何好處，它們實際上會導致認知惡化的速度有所增加。

With our particular BACE inhibitor, we could see some increases in psychiatric adverse events that gave us some pause as well as some changes on imaging, increased rate of brain shrinkage.

使用我們特定的 BACE 抑製劑，我們可以看到一些讓我們暫停的精神不良事件的增加以及成像的一些變化，腦萎縮率增加。

So that was the basis of the decision to discontinue BACE.

所以這是決定停止 BACE 的基礎。

Despite, as you said, great preclinical data showing combination of BACE inhibition and N3pG to be beneficial in mice.

儘管如您所說，大量臨床前數據顯示 BACE 抑制和 N3pG 的組合對小鼠有益。

N3pG, however, which is our plaque-clearing antibody, which really shows I think deep and rapid clearance of amyloid plaque in the brain, continues on in this Phase II study.

然而，N3pG 是我們的斑塊清除抗體，它確實表明我認為大腦中澱粉樣斑塊的深度和快速清除，在這項 II 期研究中繼續進行。

This is designed to demonstrate evidence of efficacy, and we are really excited about that.

這是為了證明有效性的證據，我們對此感到非常興奮。

Great.

偉大的。

Thank you, Dan.

謝謝你，丹。

Enrique?

恩里克?

Yes, on Jardiance and type 1, clearly, as part of the studies, we have showed that Jardiance as an adjunct to insulin in patients with type 1 can have additional level of glycemic control.

是的，關於 Jardiance 和 1 型，顯然，作為研究的一部分，我們已經表明 Jardiance 作為 1 型患者的胰島素輔助劑可以提高血糖控制水平。

And we saw this across all doses that we basically studied.

我們在基本上研究的所有劑量中都看到了這一點。

At this point in time, we are working with VI on the regulatory next steps and we hope to be able to share more shortly.

目前，我們正在與 VI 就監管的後續步驟進行合作，我們希望能夠盡快分享更多信息。

Thank you, Enrique.

謝謝你，恩里克。

And at this time, there's no one in queue.

而此時，沒有人在排隊。

Fantastic.

極好的。

Dave, if you would like to go ahead and end the call with some final remarks.

戴夫，如果您想繼續並以最後的話結束通話。

Great.

偉大的。

Thanks, Phil.

謝謝，菲爾。

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

我們感謝您參加今天的財報電話會議以及您對禮來公司的興趣。

Our strong execution through the first 9 months of 2018 highlights the continued progress towards, and the increasing confidence in the delivery of our revenue and profitability goals for 2020.

我們在 2018 年前 9 個月的強勁執行突顯了我們在實現 2020 年收入和盈利目標方面的持續進展以及對實現目標的信心增強。

We have seen continued pipeline progression, including our 10th new product launch since 2014; compelling late-stage opportunities for tirzepatide, mirikizumab and pegilodecakin, and superiority of Trulicity in the ambitious REWIND CV outcomes study.

我們看到了持續的管道進展，包括我們自 2014 年以來推出的第 10 個新產品；在雄心勃勃的 REWIND CV 結果研究中，為 tirzepatide、mirikizumab 和 pegilodecakin 以及 Trulicity 的優勢提供了令人信服的後期機會。

This progress underscores the opportunities for growth beyond 2020.

這一進展凸顯了 2020 年後的增長機會。

We look forward to providing a more detailed update on our pipeline during our December 19 investor meeting.

我們期待在 12 月 19 日的投資者會議上提供有關我們管道的更詳細更新。

Thanks, again, for dialing in.

再次感謝您撥入。

Please follow-up with our IR team if you have questions we have not addressed on the call.

如果您有我們在電話中未解決的問題，請與我們的 IR 團隊聯繫。

I hope everyone has a great day.

我希望每個人都有美好的一天。

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

女士們先生們，今天的會議到此結束。

Thank you for your participation and using AT&T executive teleconference.

感謝您參與和使用 AT&T 高管電話會議。

You may now disconnect.

您現在可以斷開連接。