禮來公司 (LLY) 2019 Q1 法說會逐字稿

Thank you, ladies and gentlemen, for standing by.

女士們，先生們，謝謝你們的支持。

Welcome to the Q1 2019 earnings call.

歡迎參加 2019 年第一季度財報電話會議。

(Operator Instructions) As a reminder, this conference is being recorded.

（操作員說明）作為提醒，本次會議正在錄製中。

I would now like to turn the conference over to our VP of Investor Relations, Kevin Hern.

我現在想將會議轉交給我們的投資者關係副總裁 Kevin Hern。

Please go ahead.

請繼續。

Thank you.

謝謝你。

Good morning.

早上好。

Thank you for joining us for Eli Lilly and Company's Q1 2019 Earnings Call.

感謝您參加禮來公司 2019 年第一季度財報電話會議。

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

我是投資者關係副總裁 Kevin Hern。

Joining me on today's call are: Dave Ricks, Lilly's Chairman and CEO; Josh Smiley, our Chief Financial Officer; Dr. Dan Skovronsky, President of Lilly Research Laboratories; Christi Shaw, President of Lilly Bio-Medicines; Anne White, President of Lilly Oncology; and Enrique Conterno, President of Lilly Diabetes and Lilly U.S.A.

與我一起參加今天電話會議的有：禮來公司董事長兼首席執行官戴夫·里克斯；我們的首席財務官 Josh Smiley；禮來研究實驗室總裁 Dan Skovronsky 博士；禮來生物醫藥總裁 Christi Shaw；禮來腫瘤學總裁 Anne White；禮來糖尿病和禮來美國公司總裁 Enrique Conterno

We're also joined by Kim Macko and Mike Czapar of the Investor Relations team.

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

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

在這次電話會議期間，我們預計會根據我們目前的預期做出預測和前瞻性陳述。

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

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向證券交易委員會提交的最新表格 10-K 和 10-Q 中概述的因素。

The information we provide about our products and 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, which exclude the financial contribution from Elanco during the first quarters of both 2018 and 2019, and present earnings per share as though the full disposition via the exchange offer was complete on January 1, 2018.

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，其中不包括 Elanco 在 2018 年和 2019 年第一季度的財務貢獻，並呈現每股收益，就好像通過交換要約於 2018 年 1 月 1 日完成。

We believe this view provides insights into the drivers of our underlying business performance as a dedicated pharmaceutical company and provides for cleaner comparisons to future and prior periods.

我們相信，這種觀點可以深入了解我們作為一家專業製藥公司的基本業務績效的驅動因素，並提供與未來和前期的更清晰的比較。

Now I'll turn the call over to Dave for a summary of our progress in Q1.

現在，我將把電話轉給 Dave，以總結我們在第一季度的進展情況。

Thanks, Kevin.

謝謝，凱文。

The company's focus in 2019 is to execute on a broad and exciting range of new products and indication launches, to build and accelerate our pipeline and continue to improve the focus and competitiveness of our company.

公司在 2019 年的重點是執行廣泛而令人興奮的新產品和適應症發布，建立和加速我們的管道，並繼續提高我們公司的重點和競爭力。

We are pleased with the progress on these objectives in Q1 2019.

我們對 2019 年第一季度在這些目標上取得的進展感到高興。

First quarter revenue grew 5% in constant currency despite a significant decline in U.S. Cialis revenue due to the recent loss of exclusivity.

儘管由於最近失去排他性，美國 Cialis 的收入顯著下降，但第一季度的收入以固定匯率計算增長了 5%。

We made significant investments in key commercial and late-stage pipeline products and delivered non-GAAP EPS of 2%, putting us on track to meet our full year financial guidance.

我們對關鍵的商業和後期管道產品進行了大量投資，並實現了 2% 的非公認會計原則每股收益，使我們有望實現全年財務指導。

Our key growth products, which all launched since 2014, contributed meaningfully to our performance and account for 39% of our revenue.

我們自 2014 年以來推出的所有關鍵增長產品都為我們的業績做出了重大貢獻，占我們收入的 39%。

While still relatively early in their product life cycles, these products continue to drive growth led by Trulicity, Taltz, Verzenio and in collaboration with Boehringer Ingelheim, Jardiance and Basaglar.

雖然仍處於產品生命週期的早期階段，但這些產品繼續推動由 Trulicity、Taltz、Verzenio 領導並與勃林格殷格翰、Jardiance 和 Basaglar 合作的增長。

Total volume growth across the entire portfolio was 7% and, excluding Cialis, was nearly 13%.

整個投資組合的總銷量增長了 7%，不包括 Cialis，接近 13%。

U.S. diabetes contributed strong volume growth of nearly 17%.

美國糖尿病貢獻了近 17% 的強勁銷量增長。

Oncology growth accelerated in the U.S., Japan and China.

美國、日本和中國的腫瘤學增長加速。

And our international markets grew volume by 9% as global launches of key brands continue across our major geographies.

隨著主要品牌的全球發布繼續在我們的主要地區推出，我們的國際市場銷量增長了 9%。

Excluding the impact of FX on international inventories sold, Q1 non-GAAP operating income as a percent of revenue decreased by nearly 600 basis points versus Q1 2018, reflecting a decrease in gross margin and investment in recent launches and multiple late-stage pipeline opportunities.

排除外匯對已售國際庫存的影響，第一季度非公認會計準則營業收入佔收入的百分比與 2018 年第一季度相比下降了近 600 個基點，這反映了毛利率和近期推出的投資以及多個後期管道機會的下降。

On the same basis, operating income as a percent of revenue in Q1 increased by nearly 80 basis points versus Q4 2018, reflecting progress toward our 2019 full year margin goal of 28%.

在同樣的基礎上，第一季度營業收入佔收入的百分比與 2018 年第四季度相比增加了近 80 個基點，反映出我們朝著 28% 的 2019 年全年利潤率目標取得了進展。

We ended Q1 on track with our plans for the full year.

我們按照全年計劃結束了第一季度。

We've invested in our future growth while delivering strong volume growth across the business.

我們投資於未來的增長，同時在整個業務中實現強勁的銷量增長。

Importantly, several pipeline assets achieved milestones this quarter, including: the regulatory submission of the Trulicity REWIND study for a CV outcomes label in the U.S. and in Europe; the FDA granted priority review for Emgality for cluster headache in the U.S.; the submission of Ultra Rapid Lispro for type 1 and type 2 diabetes in both Europe and Japan; the U.S. submission of our first connected device, a Connected Care prefilled insulin pen; and we had several Phase III data readouts.

重要的是，幾個管道資產在本季度實現了里程碑，包括：在美國和歐洲提交了用於 CV 結果標籤的 Trulicity REWIND 研究的監管提交； FDA 授予 Emgality 在美國用於叢集性頭痛的優先審查；在歐洲和日本提交用於 1 型和 2 型糖尿病的 Ultra Rapid Lispro；我們在美國提交的第一款聯網設備 Connected Care 預裝胰島素筆；我們有幾個第三階段的數據讀數。

We also announced an updated time line for expected regulatory action timing for nasal glucagon.

我們還宣布了鼻胰高血糖素預期監管行動時間的更新時間表。

We received notification the FDA has extended the review time line by up to 3 months to analyze information requested late in that review cycle.

我們收到通知，FDA 已將審查時間線延長最多 3 個月，以分析該審查週期後期要求的信息。

We remain confident in nasal glucagon's submission package and look forward to FDA action in the coming months.

我們對鼻用胰高血糖素的提交方案仍然充滿信心，並期待 FDA 在未來幾個月內採取行動。

In terms of capital deployment, we continue to utilize our strong operating cash flow to access value-creating external innovation, which will enhance our future growth prospects.

在資本配置方面，我們繼續利用我們強大的經營現金流來獲得創造價值的外部創新，這將增強我們未來的增長前景。

We completed the acquisition of Loxo Oncology, adding key pipeline assets and expanding our presence into precision medicine.

我們完成了對 Loxo Oncology 的收購，增加了關鍵的管道資產並將我們的業務擴展到精準醫療。

We completed the full separation of Elanco Animal Health via an exchange offer, retiring 65 million Lilly shares with approximately $8.2 billion.

我們通過交換要約完成了 Elanco Animal Health 的完全分離，以約 82 億美元的價格退出了 6500 萬股禮來股票。

We entered into a global licensing and research collaboration with ImmuNext, focused on new medicines for autoimmune disease.

我們與 ImmuNext 進行了全球許可和研究合作，專注於自身免疫性疾病的新藥。

We announced a global licensing and research collaboration with Avidity, focused on potential new medicines in immunology and select other indications.

我們宣布與 Avidity 開展全球許可和研究合作，重點關注免疫學領域的潛在新藥並選擇其他適應症。

We announced an agreement to sell the rights in China for 2 legacy Lilly antibiotic medicines as well as a manufacturing facility to Eddingpharm, a Chinese-based specialty pharmaceutical company.

我們宣布了一項協議，向總部位於中國的專業製藥公司 Eddingpharm 出售 2 種傳統禮來（Lilly）抗生素藥物和生產設施在中國的權利。

And we returned an additional $3.5 billion to shareholders via a previously announced accelerated share repurchase program and $600 million in dividends, representing a 15% increase per share versus 2018.

我們通過先前宣布的加速股票回購計劃和 6 億美元的股息向股東返還了額外的 35 億美元，與 2018 年相比，每股增長了 15%。

Moving on to Slides 5 and 6, you'll see more details on key events since our February earnings call, including our announcement to introduce Insulin Lispro, a low-priced version of Humalog in the U.S.

轉到幻燈片 5 和 6，您將看到自 2 月份財報電話會議以來關鍵事件的更多詳細信息，包括我們宣佈在美國推出低價版 Humalog 胰島素 Lispro。

Now I'll turn the call over to Josh to review our Q1 results and to provide an update on our post-Elanco financial guidance.

現在，我將把電話轉給喬什，以審查我們的第一季度業績，並提供我們在 Elanco 後財務指導的最新信息。

Thanks, Dave.

謝謝，戴夫。

Slide 7 summarizes our presentation of GAAP results and non-GAAP measures, and 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，幻燈片 8 總結了我們的 GAAP 結果。

Looking at the non-GAAP measures on Slide 9, you'll see revenue increased 3%.

查看幻燈片 9 上的非 GAAP 指標，您會看到收入增長了 3%。

Excluding the impact of FX on international inventories sold, gross margin as a percent of revenue was 80.2%, in line with our long-term goals for manufacturing efficiency and profitability.

排除外匯對銷售的國際庫存的影響，毛利率佔收入的百分比為 80.2%，符合我們製造效率和盈利能力的長期目標。

On the same basis, gross margin declined 130 basis points compared to Q1 2018 driven by production timing and lower volumes from post-patent products.

同樣，由於生產時間和專利後產品的銷量下降，毛利率與 2018 年第一季度相比下降了 130 個基點。

Total operating expense increased 12% with marketing, selling and administrative expense increasing 13% driven primarily by increased investment to support our recent launches, including DTC campaigns to drive awareness for Emgality, Verzenio and Taltz.

總運營費用增加了 12%，營銷、銷售和行政費用增加了 13%，這主要是由於增加投資以支持我們最近的發布，包括 DTC 活動以提高 Emgality、Verzenio 和 Taltz 的知名度。

R&D expense increased 11%, reflecting the ramp-up of multiple late-stage pipeline assets, the addition of the Loxo Oncology portfolio and Incyte communicating to us that they would no longer co-fund the development of baricitinib, which reduces the royalty we will pay them moving forward.

研發費用增加了 11%，這反映了多個後期管道資產的增加、Loxo 腫瘤學產品組合的增加以及 Incyte 向我們傳達他們將不再共同資助 baricitinib 的開發，這降低了我們將獲得的特許權使用費支付他們前進。

As a result of the investments described above, operating income decreased 8% compared to Q1 2018, which put our operating income as a percent of sales at 26.2% for the quarter.

由於上述投資，營業收入與 2018 年第一季度相比下降了 8%，這使我們本季度的營業收入佔銷售額的百分比為 26.2%。

As our recent launches continue to drive revenue and operating leverage, we expect income growth and improvements in operating margin during the remainder of 2019.

由於我們最近推出的產品繼續推動收入和運營槓桿，我們預計 2019 年剩餘時間內收入增長和運營利潤率提高。

Other income and expense was income of $86 million this quarter compared to income of $70 million in Q1 2018 driven by over $100 million in gains of mark-to-market of public equities held through venture capital investments and strategic partnerships partially offset by higher net interest expense.

其他收入和支出為本季度的收入為 8600 萬美元，而 2018 年第一季度的收入為 7000 萬美元，原因是通過風險資本投資和戰略合作夥伴關係持有的上市股票按市值計價的收益超過 1 億美元，部分被較高的淨利息所抵消費用。

Our tax rate for the quarter was 12.9%, a decrease of 260 basis points compared with the same quarter last year, driven primarily by timing associated with the impact of the U.S. tax reform.

我們本季度的稅率為 12.9%，與去年同期相比下降了 260 個基點，主要受美國稅制改革影響的時機驅動。

At the bottom line, net income declined 4%, while earnings per share increased 2% due to a reduction in shares outstanding from share repurchases.

歸根結底，淨收入下降了 4%，而每股收益增長了 2%，原因是來自股票回購的流通股減少。

Recall that our non-GAAP comparisons remove the 65 million shares retired through the Elanco exchange for both 2018 and 2019.

回想一下，我們的非 GAAP 比較刪除了 2018 年和 2019 年通過 Elanco 交易所退休的 6500 萬股。

While income declined this quarter versus Q1 2018, we made important progress on several fronts that will drive future growth as demonstrated by: growing revenue despite significant headwinds from the loss of exclusivity of Cialis in the U.S.; investing behind key growth brands such as Emgality, Verzenio, Taltz, Jardiance and Trulicity; and advancing several pipeline assets to the next phase of development, including multiple regulatory submissions.

儘管本季度的收入與 2018 年第一季度相比有所下降，但我們在幾個方面取得了重要進展，這將推動未來的增長，如下所示： 儘管 Cialis 在美國失去獨家經營權帶來了重大阻力，但收入仍在增長；投資於 Emgality、Verzenio、Taltz、Jardiance 和 Trulicity 等關鍵增長品牌；並將多個管道資產推進到下一階段的開發，包括多項監管提交。

Slide 10 provides a reconciliation between reported and non-GAAP EPS.

幻燈片 10 提供了報告和非公認會計原則每股收益之間的對賬。

And you'll find additional details on these adjustments on Slide 23.

您可以在幻燈片 23 上找到有關這些調整的更多詳細信息。

Moving to Slide 11.

轉到幻燈片 11。

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

讓我們看看價格率和銷量對收入增長的影響。

This quarter, foreign exchange reduced revenue growth by 2 percentage points.

本季度，外匯收入增長減少了2個百分點。

As Dave mentioned earlier, worldwide revenue grew 5% on a performance basis driven by a 7% increase in volume partially offset by price.

正如 Dave 之前提到的，全球收入在業績的基礎上增長了 5%，這是由於銷量增長 7% 被價格部分抵消。

Q1 is the ninth straight quarter our business grew volume in each major geography.

第一季度是我們在每個主要地區的業務量連續第九個季度增長。

U.S. revenue increased 30%.

美國收入增長了 30%。

Like last quarter, Trulicity, Taltz, Verzenio and Basaglar were the key drivers of 6% volume growth, partially offset by price.

與上一季度一樣，Trulicity、Taltz、Verzenio 和 Basaglar 是銷量增長 6% 的主要驅動力，但部分被價格抵消。

Excluding Cialis, volume grew nearly 15% in the U.S., highlighted by diabetes products delivering nearly 17% volume growth.

不包括希愛力，美國的銷量增長近 15%，其中糖尿病產品銷量增長近 17% 尤為突出。

Consistent with our 2019 financial guidance, U.S. price declined 3% driven by increased utilization of patient affordability programs mainly for insulin and Taltz, adjustments through estimates from rebates and discounts and higher contracted rates primarily related to Trulicity, which were partially offset by favorable segment mix across the portfolio.

與我們 2019 年的財務指導一致，美國價格下跌 3%，原因是患者負擔能力計劃的使用增加，主要是胰島素和 Taltz，通過回扣和折扣的估計進行調整，以及主要與 Trulicity 相關的更高合同費率，這部分被有利的細分市場組合所抵消整個投資組合。

Moving to Europe.

搬到歐洲。

Strong volume growth of 9% was largely offset by the negative effect of foreign exchange and, to a lesser extent, price.

9% 的強勁銷量增長在很大程度上被外彙和價格的負面影響所抵消。

Volume growth was led by Trulicity, Olumiant and Taltz.

銷量增長由 Trulicity、Oluminant 和 Taltz 引領。

In Japan, strong volume growth of 7% driven by Cymbalta, Verzenio and Trulicity was largely offset by a drag of 6% from price as a result of the government-mandated price decreases that went into effect in 2018.

在日本，由 Cymbalta、Verzenio 和 Trulicity 推動的 7% 的強勁銷量增長在很大程度上被 2018 年生效的政府強制降價導致的 6% 的價格拖累所抵消。

Revenue in the rest of the world increased 9% on a performance basis this quarter led by volume growth from Humalog, Trulicity, Cialis, Jardiance and the recently launched Tyvyt, a China-only anti-PD-1 immunotherapy agent in collaboration with Innovent Biologics.

本季度全球其他地區的收入在業績基礎上增長了 9%，這主要得益於 Humalog、Trulicity、Cialis、Jardiance 和最近推出的 Tyvyt 的銷量增長，Tyvyt 是中國唯一與信達生物合作的抗 PD-1 免疫治療藥物.

As shown on Slide 12, our key growth drivers were once again the engine of our worldwide volume growth.

如幻燈片 12 所示，我們的主要增長動力再次成為我們全球銷量增長的引擎。

These products drove 14.8 percentage points of volume growth this quarter, an increase of over 100 basis points versus their contribution to growth in Q4 2018.

這些產品在本季度推動了 14.8 個百分點的銷量增長，與 2018 年第四季度對增長的貢獻相比增加了 100 多個基點。

Brands that have experienced loss of exclusivity provided a drag of 530 basis points driven primarily by Cialis.

經歷了排他性損失的品牌拖累了 530 個基點，主要由 Cialis 推動。

You may recall, the generic versions of Cialis entered the U.S. market at the end of September last year, and as expected, we've seen a rapid erosion of sales.

您可能還記得，Cialis 的仿製藥於去年 9 月底進入美國市場，正如預期的那樣，我們看到銷售迅速下滑。

When excluding LOEs, the rest of our products posted robust Q1 volume growth of nearly 16%.

排除 LOE 後，我們的其他產品在第一季度實現了近 16% 的強勁銷量增長。

Slide 13 provides a view of our key growth products.

幻燈片 13 展示了我們的主要增長產品。

In total, these brands generated nearly $2 billion of revenue this quarter, representing 39% of revenue.

這些品牌本季度總共創造了近 20 億美元的收入，佔收入的 39%。

Trulicity continues to post robust growth, having achieved over 45% total share of the U.S. market in a rapidly expanding class that grew nearly 30% this quarter.

Trulicity 繼續保持強勁增長，在本季度增長近 30% 的快速擴張類別中，在美國市場的總份額已超過 45%。

Similarly, Jardiance posted impressive U.S. share gains and volume growth, now capturing 50% and 64% share of market in total and new prescriptions, respectively.

同樣，Jardiance 在美國的份額增長和銷量增長令人印象深刻，目前分別佔據了總處方藥和新處方藥市場的 50% 和 64% 的份額。

Both products continue to be the market leaders in their classes.

這兩種產品仍然是同類產品中的市場領導者。

Emgality's launch trajectory continued to be strong with nearly 33% share of market for new prescriptions in the U.S., an increase of almost 13 share points from where we finished 2018.

Emgality 的推出軌跡繼續強勁，在美國新處方藥的市場份額接近 33%，與 2018 年相比增加了近 13 個份額點。

We expect increasingly strong performance in the U.S. combined with best-in-class access to drive meaningful sales contribution in the second half of 2019.

我們預計美國的業績將越來越強勁，再加上一流的准入，將在 2019 年下半年推動有意義的銷售貢獻。

Continuing with our non-GAAP explanations on Slide 14.

繼續我們在幻燈片 14 上的非 GAAP 解釋。

Foreign exchange rate had a modest impact on our revenue but have more meaningful impact on cost of sales due to the effect in last year's quarter, resulting in the mid-single-digit impact to operating income and EPS.

匯率對我們的收入影響不大，但由於去年季度的影響，對銷售成本的影響更大，對營業收入和每股收益產生了中個位數的影響。

Turning to our 2019 financial guidance on Slide 15.

轉向我們關於幻燈片 15 的 2019 年財務指導。

You'll see that we've maintained a non-GAAP pharma-only expectations we shared in February and with the Elanco exchange offer complete, are now providing EPS on the same basis.

您會看到，我們保持了我們在 2 月份分享的非 GAAP 僅限製藥公司的預期，並且隨著 Elanco 交換報價的完成，現在在相同的基礎上提供每股收益。

Our non-GAAP earnings per share range is $5.60 to $5.70, an increase of $0.05 versus our previously issued guidance range which included Elanco.

我們的非公認會計原則每股收益範圍為 5.60 美元至 5.70 美元，與我們之前發布的包括 Elanco 在內的指導範圍相比增加了 0.05 美元。

While the line items remain unchanged from the previously communicated pharma-only expectations, I'd highlight 2 items that impact our outlook for the remainder of 2019.

雖然這些項目與之前傳達的僅限製藥公司的預期保持不變，但我要強調影響我們 2019 年剩餘時間展望的 2 個項目。

First, we will manage expenses to deliver within our SG&A range while investing thoughtfully to drive continued revenue growth.

首先，我們將管理費用以在我們的 SG&A 範圍內交付，同時謹慎投資以推動收入的持續增長。

And second, in Q1, OID benefited from mark-to-market equity gains, and our tax rate benefited from a net discrete item.

其次，在第一季度，OID 受益於按市值計價的股權收益，我們的稅率受益於淨離散項目。

We are maintaining our full year outlook for these items, however, as these items are highly variable, and it is early in the year.

然而，我們維持對這些項目的全年展望，因為這些項目變化很大，而且現在是年初。

Touching briefly on our updated GAAP guidance.

簡要介紹我們更新的 GAAP 指南。

We expect earnings per share to be in the range of $8.57 to $8.67, which includes the $3.7 billion gain on the disposition of Elanco recorded in discontinued operations.

我們預計每股收益將在 8.57 美元至 8.67 美元之間，其中包括終止經營中記錄的處置 Elanco 的 37 億美元收益。

On Slide 16, we provide an update on our recent activity regarding capital allocation.

在幻燈片 16 上，我們提供了我們最近有關資本配置的活動的最新信息。

Consistent with our strategic priorities, we spent over $8 billion on initiatives to drive future growth.

根據我們的戰略重點，我們在推動未來增長的舉措上花費了超過 80 億美元。

In addition to investing in internal R&D, we closed the Loxo Oncology acquisition, which augmented our pipeline and returned over $4 billion of cash to shareholders.

除了投資內部研發外，我們還完成了對 Loxo Oncology 的收購，這擴大了我們的管道並向股東返還了超過 40 億美元的現金。

As Dave mentioned earlier, we completed the successful divestiture of Elanco this quarter via an exchange offer.

正如戴夫之前提到的，我們本季度通過交換要約完成了對 Elanco 的成功剝離。

We exited Elanco with an attractive price and recognized a $3.7 billion gain on the disposition.

我們以極具吸引力的價格退出了 Elanco，並確認此次處置獲得了 37 億美元的收益。

In addition, the exchange offer was substantially oversubscribed and resulted in an earnings accretion in 2019 from retiring Lilly shares.

此外，交換要約大幅超額認購，並導致 2019 年因禮來公司股票退休而增加收益。

As we have returned to growth, our confidence in our business outlook has been reflected in meaningful dividend increases in 2018 and 2019.

隨著我們恢復增長，我們對業務前景的信心已反映在 2018 年和 2019 年的股息增長中。

As we move ahead, our ability to continue to generate strong operating cash flow supports our pursuit of external innovation to enhance our long-term growth and create shareholder value.

隨著我們向前邁進，我們繼續產生強勁的經營現金流的能力支持我們追求外部創新，以提高我們的長期增長和創造股東價值。

Now we will turn the call over to Dan to highlight our progress on R&D.

現在我們將把電話轉給 Dan 來強調我們在研發方面的進展。

Thanks, Josh.

謝謝，喬希。

Slide 17 shows select pipeline opportunities as of April 24.

幻燈片 17 顯示了截至 4 月 24 日的選定管道機會。

Movements since our last earnings call includes: the regulatory submission of Trulicity REWIND data for CV outcomes label in the U.S. and Europe; submission of our Connected Care prefilled insulin pen for type 1 and type 2 diabetes in the U.S.; submission of a fixed-dose combination of empagliflozin, linagliptin and metformin XR for type 2 diabetes in the U.S.; and submission of Ultra Rapid Lispro for type 1 and type 2 diabetes in Europe and Japan.

自上次財報電話會議以來的變動包括：在美國和歐洲向監管機構提交了用於 CV 結果標籤的 Trulicity REWIND 數據；在美國提交我們用於 1 型和 2 型糖尿病的 Connected Care 預填充胰島素筆；在美國提交用於 2 型糖尿病的 empagliflozin、linagliptin 和二甲雙胍 XR 的固定劑量組合；並在歐洲和日本提交了用於 1 型和 2 型糖尿病的 Ultra Rapid Lispro。

We also highlight the initiation of Phase II testing for our IL-33 monoclonal antibody and immunology, the initiation of Phase I testing for 3 new molecular entities, including our GIP/GLP glucagon tri-agonist and the attrition of 2 Phase II molecules.

我們還強調了對我們的 IL-33 單克隆抗體和免疫學的 II 期測試的啟動，對 3 個新分子實體的 I 期測試的啟動，包括我們的 GIP/GLP 胰高血糖素三激動劑和 2 個 II 期分子的損耗。

With the submission of Ultra Rapid Lispro, we're now on track to deliver 12 NME approvals since 2014.

隨著 Ultra Rapid Lispro 的提交，我們現在有望自 2014 年以來提供 12 個 NME 批准。

Therefore, a common question I get is, "What's next?" As we replenish our late-stage pipeline in the past 12 months, we've made 4 big innovation bets with mirikizumab, pegilodecakin, our recently acquired RET inhibitor, and tirzepatide.

因此，我得到的一個常見問題是，“下一步是什麼？”在過去 12 個月中，隨著我們補充後期管道，我們在 mirikizumab、pegilodecakin、我們最近收購的 RET 抑製劑和 tirzepatide 方面進行了 4 次重大創新押注。

Moving to Slide 18.

轉到幻燈片 18。

Mirikizumab is our IL-23 and Phase III for psoriasis and ulcerative colitis with expected data readouts in 2020 and 2021, respectively.

Mirikizumab 是我們用於銀屑病和潰瘍性結腸炎的 IL-23 和 III 期臨床試驗，預計數據分別在 2020 年和 2021 年公佈。

We see first-in-class potential for ulcerative colitis, a disease with high unmet need and growing incidents where we saw strong Phase II efficacy in clinical response and endoscopic healing.

我們看到了潰瘍性結腸炎的一流潛力，這是一種具有高度未滿足需求和不斷增加的疾病，我們在臨床反應和內窺鏡癒合方面看到了強大的 II 期療效。

Based on positive Phase II data on Crohn's disease, which we'll be presenting in a few weeks at DDW, we're now moving quickly into Phase III for Crohn's disease yet this year.

基於克羅恩病的積極 II 期數據，我們將在幾週後在 DDW 上展示這些數據，我們現在正在迅速進入克羅恩病的 III 期，但今年。

Pegilodecakin is our first-in-class PEGylated IL-10 from ARMO BioSciences.

Pegilodecakin 是我們來自 ARMO BioSciences 的一流聚乙二醇化 IL-10。

We see strong biologic rationale, a single agent activity in renal cancer.

我們看到了強有力的生物學原理，即腎癌中的單一藥物活性。

There's also an intriguing signal in combination with both chemotherapy and checkpoint inhibitors in several tumor types.

在幾種腫瘤類型中，與化療和檢查點抑製劑相結合也有一個有趣的信號。

We're looking forward to data readouts from the Cypress 1 and 2 non-small cell lung cancer studies by the end of this year as well as the Phase III pancreatic cancer trial in 2020.

我們期待在今年年底之前從 Cypress 1 和 2 非小細胞肺癌研究以及 2020 年進行 III 期胰腺癌試驗的數據讀出。

We'll also be starting a clinical program in renal cell carcinoma this year.

今年我們還將開始一項腎細胞癌臨床項目。

Our most recent late-stage entry is our potential first-in-class and best-in-class RET inhibitor from Loxo Oncology.

我們最近的後期進入是我們潛在的一流和一流的 RET 抑製劑，來自 Loxo Oncology。

Currently in the Phase II portion of the LIBRETTO-001 study, we look forward to having both additional data readout and a regulatory submission by the end of this year.

目前處於 LIBRETTO-001研究的第二階段，我們期待在今年年底之前獲得額外的數據讀出和監管提交。

This molecule has received breakthrough designation from the FDA for 3 indications: RET fusion-positive non-small cell lung cancer, RET mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.

該分子已獲得 FDA 對 3 個適應症的突破性指定：RET 融合陽性非小細胞肺癌、RET 突變甲狀腺髓樣癌和 RET 融合陽性甲狀腺癌。

We're excited about the data we've seen to date, which has sawn robust response rates and encouraging response durations.

我們對迄今為止看到的數據感到興奮，這些數據顯示出強勁的響應率和令人鼓舞的響應持續時間。

We look forward to presenting new data at a medical meeting in the second half of this year.

我們期待在今年下半年的醫學會議上展示新數據。

Finally, tirzepatide, our novel first-in-class and best-in-class GIP/GLP dual agonist incretin which started its Phase III SURPASS program in late 2018 on the heels of presenting impressive Phase II results in October at EASD.

最後，tirzepatide 是我們的新型一流和一流的 GIP/GLP 雙激動劑腸促胰島素，在 10 月在 EASD 上展示了令人印象深刻的 II 期結果之後，於 2018 年底開始了其 III 期 SURPASS 計劃。

We believe tirzepatide could provide levels of efficacy not seen with existing products.

我們相信 tirzepatide 可以提供現有產品所沒有的療效水平。

Also, past studies for the global submissions should start by the end of the year with data expected in 2021.

此外，過去對全球提交的研究應在今年年底開始，預計在 2021 年提供數據。

We also expect to initiate Phase III studies in obesity and a Phase II study in NASH later this year.

我們還預計在今年晚些時候啟動肥胖症的 III 期研究和 NASH 的 II 期研究。

We look forward to presenting new data at ADA in June on tirzepatide, including the additional dose escalation data from a Phase II trial in diabetes, data from a Japan clinical trial and new biomarker data from our Phase II trial supporting potential efficacy for NASH.

我們期待在 6 月的 ADA 上展示有關 tirzepatide 的新數據，包括來自糖尿病 II 期試驗的額外劑量遞增數據、來自日本臨床試驗的數據以及來自我們 II 期試驗的新生物標誌物數據，以支持 NASH 的潛在療效。

We're excited about this cohort of innovative, first-in-class late-stage assets, each with a potential to improve the standard of care across immunology, oncology and diabetes.

我們對這批創新的、一流的晚期資產感到興奮，每一個都有可能提高免疫學、腫瘤學和糖尿病的護理標準。

We look forward to what's next from these assets as they achieve important milestones and readouts over the next 12 months.

我們期待這些資產的下一步發展，因為它們在未來 12 個月內實現了重要的里程碑和讀數。

Slide 19 shows a tally of the significant progress we've made since our last earnings call and key events we're monitoring for 2019, including submissions across 4 key line extensions or NMEs that I described earlier: the regulatory submission of Emgality for episodic cluster headache in Europe; positive results from CAROLINA CV outcomes study of Trajenta; positive results for a Phase III study of Taltz for non-radiographic axial spondyloarthritis; results from 2 Phase III studies of tanezumab, the first in patients with chronic lower back pain and the second, a long-term safety study in patients with osteoarthritis pain; positive results from a Phase III study of CYRAMZA for first-line EGFR non-small cell lung cancer.

幻燈片 19 顯示了自上次財報電話會議以來我們取得的重大進展以及我們在 2019 年監控的關鍵事件，包括我之前描述的跨 4 個關鍵線擴展或 NME 的提交：Emgality 對情節集群的監管提交歐洲頭痛； Trajenta 的 CAROLINA CV 結果研究的積極結果； Taltz 治療非放射軸性脊柱關節炎的 III 期研究的積極結果；來自 tanezumab 的 2 項 III 期研究的結果，第一項是針對慢性腰痛患者，第二項是針對骨關節炎疼痛患者的長期安全性研究； CYRAMZA 用於一線 EGFR 非小細胞肺癌的 III 期研究的陽性結果。

We also note that we received notification that for technical reasons, the FDA has refused to file the supplemental NDA for empagliflozin in type 1 diabetes, and that we have made a decision to not pursue the development of Olumiant for psoriatic arthritis.

我們還注意到，我們收到通知稱，出於技術原因，FDA 拒絕為 1 型糖尿病的 empagliflozin 提交補充 NDA，並且我們已決定不繼續開髮用於銀屑病關節炎的 Olumiant。

In addition to the late-stage highlights I shared with you today, we're growing our early-stage pipeline through both enhanced internal productivity and external innovation.

除了我今天與您分享的後期亮點外，我們還通過提高內部生產力和外部創新來發展我們的早期管道。

We'll highlight several examples in upcoming earnings calls.

我們將在即將召開的財報電話會議中重點介紹幾個示例。

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

現在我將把電話轉回給戴夫做一些結束語。

Thanks, Dan.

謝謝，丹。

In the first quarter, we delivered strong volume-based revenue growth of 5% on a constant-currency basis driven entirely by our key growth products.

在第一季度，我們實現了基於數量的強勁收入增長，按固定匯率計算，完全由我們的主要增長產品推動。

We made strategic investments in commercial and late-stage products, which will enhance our future growth prospects.

我們對商業和後期產品進行了戰略投資，這將增強我們未來的增長前景。

We've seen good pipeline progress this quarter, including a number of regulatory submissions.

我們在本季度看到了良好的管道進展，包括一些監管提交。

In addition, we bolstered our early-phase pipeline by advancing multiple assets into the clinic and signing research agreements.

此外，我們通過將多項資產推進臨床和簽署研究協議來支持我們的早期管道。

We also completed 2 significant transactions that will allow us to simultaneously focus the business and accelerate our pipeline of innovative medicines: the disposition of Elanco and the acquisition of Loxo Oncology.

我們還完成了兩項重大交易，使我們能夠同時專注於業務並加速我們的創新藥物管道：處置 Elanco 和收購 Loxo Oncology。

Finally, we returned over $4 billion to shareholders either dividend and share repurchases.

最後，我們向股東返還了超過 40 億美元的股息和股票回購。

Speaking for the entire team at Lilly, we remain incredibly excited about the prospects in front of us to reach millions of people who need better medicines for difficult diseases.

就禮來的整個團隊而言，我們仍然對我們面前的前景感到非常興奮，這些人可以接觸到數百萬需要更好的藥物來治療疑難病的人。

And we are eager to continue to execute on the growth opportunity in front of the company.

我們渴望繼續抓住公司面前的增長機會。

This concludes our prepared remarks.

我們準備好的評論到此結束。

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

現在我將把電話轉給凱文來主持我們的問答。

Thanks, Dave.

謝謝，戴夫。

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

（操作員說明）Karen，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) We'll go to the line of Chris Schott from JPMorgan.

（操作員說明）我們將前往摩根大通的 Chris Schott。

The first one from me was just elaborating a little bit more on Trulicity dynamics this quarter, particularly as you think about price.

我的第一個只是詳細闡述了本季度的 Trulicity 動態，特別是當你考慮價格時。

I just want to make sure I heard the comments in the prepared remarks properly.

我只是想確保我正確地聽到了準備好的評論中的評論。

But how should we be thinking about net pricing and the overall pricing environment for Trulicity in 2019?

但是我們應該如何考慮 2019 年 Trulicity 的淨定價和整體定價環境呢？

And were there any onetime impacts or true-ups of rebates for Trulicity this quarter?

本季度對 Trulicity 的回扣是否有任何一次性影響或修正？

My second question is just a really quick one on Emgality.

我的第二個問題是關於 Emgality 的一個非常快速的問題。

And just how we should be thinking about where net pricing was going to shake out for this one?

以及我們應該如何考慮淨定價將在哪裡動搖？

And should we think about second quarter results reflecting maybe a more normalized gross to net than we saw with the Q1 results?

我們是否應該考慮第二季度的結果，反映的總淨額可能比我們在第一季度的結果中看到的更加標準化？

Thanks, Chris.

謝謝，克里斯。

We'll go to Enrique for Trulicity and then Christi for Emgality.

我們將前往 Enrique 尋求 Trulicity，然後前往 Christi 尋求 Emgality。

Chris, thank you for your question.

克里斯，謝謝你的提問。

Allow me to provide some color on Trulicity's overall performance.

請允許我為 Trulicity 的整體表現提供一些色彩。

We continue to be very excited about the underlying business fundamentals of the product.

我們繼續對該產品的基本業務基礎感到非常興奮。

When we look at volume growth, we are basically the beneficiary of very strong share growth.

當我們看銷量增長時，我們基本上是非常強勁的份額增長的受益者。

We're now sitting at 46%, which is an all-time high for Trulicity, and with the tailwind of very significant class growth now sitting at 30%.

我們現在的增長率為 46%，這是 Trulicity 的歷史最高水平，而且隨著班級增長非常顯著的順風現在達到 30%。

Something to note is when we look at sequentially at volume, while scripts basically increased for Trulicity from Q4 of '18 to Q1 of '19 by about 5%, 6%, our actual shipments declined by 7%.

需要注意的是，當我們按順序查看數量時，從 18 年第四季度到 19 年第一季度，Trulicity 的腳本基本上增加了大約 5%、6%，我們的實際出貨量下降了 7%。

So I want to make sure that we are looking at the underlying business fundamentals, not necessarily just some shift in retail or wholesale or inventory dynamics.

因此，我想確保我們關注的是潛在的業務基本面，而不僅僅是零售、批發或庫存動態的一些轉變。

When it comes to pricing, there's -- there hasn't been a step change when it comes to pricing.

在定價方面，在定價方面沒有發生變化。

I think, of course, we see pricing pressures across all diabetes categories, but it's important to note that our price this quarter was comparable to our price in Q4 of '18.

我認為，當然，我們看到所有糖尿病類別的定價壓力，但重要的是要注意，我們本季度的價格與 18 年第四季度的價格相當。

Now what we basically see in terms of pricings relative to Q1 of '18 is high rates when it comes to managed care and rebates; growth in highly rebated segments, whether it's the Department of Defense, VA and so forth; and then we also had a negative impact due to changes in the estimates for rebates and discounts.

現在，我們在相對於 18 年第一季度的定價方面基本上看到的是管理式醫療和回扣的高利率；高回扣部門的增長，無論是國防部、弗吉尼亞州等；然後，由於對回扣和折扣的估計發生變化，我們也產生了負面影響。

And Chris, on Emgality, your question on net pricing, and will it be more normalized on gross to net in Q2.

還有克里斯，關於 Emgality，你關於淨定價的問題，以及它在第二季度的總淨值是否會更加正常化。

What we saw in Q1, first of all, in demand, very excited about the fact that we are now the #2 CGRP-passing Ajovy in both new prescriptions and total prescriptions, and we're on track in Q2 to pass Aimovig in new prescriptions.

我們在第一季度看到的，首先，需求旺盛，我們現在在新處方和總處方中都是通過 CGRP 的 Ajovy 排名第二，而且我們有望在第二季度通過新的 Aimovig處方。

As we look at the net, we saw a higher-than-typical free goods as reimbursement was coming on.

當我們查看網絡時，我們看到了高於典型的免費商品，因為報銷即將到來。

To give you a little bit of flavor, the first quarter had a 57% of commercial claims were reimbursed.

為了給你一點味道，第一季度有 57% 的商業索賠得到了報銷。

We exited Q1 at 67 or 2 out of every 3 prescriptions or claims, commercial claims being reimbursed.

我們以每 3 個處方或索賠中的 67 個或 2 個退出第一季度，商業索賠得到報銷。

So as the reimbursement comes on in Q2, we should see improvement in that.

因此，隨著第二季度的報銷開始，我們應該會看到這方面的改善。

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

接下來，我們將轉到美國銀行的 Jason Gerberry。

Christi, just a follow-up on the Emgality comment.

克里斯蒂，只是對 Emgality 評論的跟進。

I know that a lot of companies in this space have kind of framed second half payer environment is a little bit fluid.

我知道這個領域的很多公司都有一種框架下的下半年付款人環境有點不穩定。

So is your comment that -- where you exited once you -- should we be thinking about that as a linear trend?

那麼你的評論是 - 你曾經退出的地方 - 我們應該將其視為線性趨勢嗎？

Are there any puts and takes going on, changes in the reimbursement of CGRP biologics?

CGRP 生物製劑的報銷是否有任何變動？

Just wanted to get a better sense there.

只是想在那裡獲得更好的感覺。

And I guess, my follow-up, probably staying with you, AbbVie's SKYRIZI got pretty good early access.

我想，我的後續行動，可能會和你在一起，艾伯維的 SKYRIZI 獲得了很好的早期訪問。

And so I'm just sort of curious your thoughts, winners and losers there, either via the established novel interleukins, or do you see this as more as cannibalization of AbbVie's own Humira franchise?

所以我只是有點好奇你的想法，那裡的贏家和輸家，要么是通過已建立的新型白細胞介素，還是你認為這更像是對艾伯維自己的 Humira 特許經營權的蠶食？

Sure.

當然。

So continuing on Emgality in terms of access, first of all, we saw very good receptivity by the payers for this class, really giving doctors' and patients' choice, and also not having many, if any, real restrictions for primary care prescribing.

因此，在訪問方面繼續 Emgality，首先，我們看到支付者對這個類的接受度非常好，真正給了醫生和患者的選擇，而且對初級保健處方也沒有太多（如果有的話）真正的限制。

On the -- so on the reimbursement side, we see the payers coming onboard and more and more coming onboard.

在 - 所以在報銷方面，我們看到付款人加入進來，越來越多的人加入進來。

Right now, our access ending Q1 is 82%.

目前，我們在第一季度結束時的訪問率為 82%。

So we do expect that to get better and better over the course of the year.

因此，我們確實希望在這一年中變得越來越好。

So I hope that answers your question there.

所以我希望在那裡回答你的問題。

On SKYRIZI, another data on SKYRIZI is as expected.

在 SKYRIZI 上，SKYRIZI 上的另一個數據與預期相符。

And as we look at Taltz' ability to compete, the competitive landscape that we -- environment that we're in really doesn't change.

當我們審視 Taltz 的競爭能力時，我們所處的競爭格局——我們所處的環境並沒有真正改變。

Access is very similar.

訪問非常相似。

SKYRIZI and Tremfya, Taltz, all of the newer agents really coming to market have helped increased the expectations that patients and doctors should have on really skin clearance.

SKYRIZI 和 Tremfya，Taltz，所有真正進入市場的新型藥物都有助於提高患者和醫生對真正皮膚清除的期望。

And so it's a competitive marketplace, but we like our chances because with Taltz in the dermatology office, we know clear skin very fast, and it lasts up to 5 years.

所以這是一個競爭激烈的市場，但我們喜歡我們的機會，因為在皮膚科辦公室使用 Taltz，我們可以非常快速地了解皮膚清潔，並且可以持續長達 5 年。

We've seen data that it's sustained and no new safety signals.

我們已經看到數據表明它是持續的，沒有新的安全信號。

And we also have the head-to-head versus an IL-23 that will be coming out this year, which will demonstrate that speed and clearance at 12 weeks and 24 weeks for the IL-23s really show their peak efficacy.

我們還有今年將推出的 IL-23 的正面交鋒，這將證明 IL-23 在 12 周和 24 週時的速度和清除率確實顯示出它們的峰值功效。

So we're looking forward to that.

所以我們很期待。

And in rheumatology, we'll continue to compete there as we just released our head-to-head data versus Humira showing superiority and then later this year being able to look at the regulatory approval of AxSpA.

在風濕病領域，我們將繼續在那裡競爭，因為我們剛剛發布了與 Humira 的正面交鋒數據，顯示出優勢，然後在今年晚些時候能夠看到 AxSpA 的監管批准。

So the competition is fierce, but our chances and our odds with Taltz are extremely good.

所以競爭很激烈，但我們與 Taltz 的機會和勝算都非常好。

And we don't see a huge difference in the landscape because of SKYRIZI coming on.

由於 SKYRIZI 的出現，我們並沒有看到景觀的巨大差異。

Seamus Fernandez from Guggenheim.

來自古根海姆的 Seamus Fernandez。

So just a couple of quick questions.

所以只是幾個簡單的問題。

As we think about the evolving competitive landscape in the insulin space, we've seen Admelog take up quite a bit of share in a short period of time, and then there's also the threat of potential biosimilars reaching the market in the next couple of years

當我們考慮胰島素領域不斷變化的競爭格局時，我們已經看到 Admelog 在短時間內佔據了相當大的份額，然後還有潛在的生物仿製藥在未來幾年進入市場的威脅

(technical difficulty)

（技術難度）

the evolving landscape and how that potentially impacts your portfolio as it relates to Humalog or also for the long-acting insulins going forward.

不斷變化的環境以及這可能如何影響您的投資組合，因為它與 Humalog 或未來的長效胰島素有關。

And then just a second quick question for Dan.

然後是丹的第二個快速問題。

You guys have some data on your ERK inhibitor at ASCO.

你們在 ASCO 有一些關於 ERK 抑製劑的數據。

Just hoping that you could give us your thoughts on data coming at ASCO for that product and perhaps any other data sets that you think we should be watching for.

只是希望您能就 ASCO 為該產品提供的數據以及您認為我們應該關注的任何其他數據集向我們提供您的想法。

Thank you.

謝謝你。

Enrique, if you want to answer the insulin question, then we'll go to Dan.

恩里克，如果你想回答胰島素問題，那我們去找丹。

Sure.

當然。

Clearly, there are new competitors in the insulin space.

顯然，胰島素領域出現了新的競爭對手。

I think in the case of Admelog, I think it's important to reflect that their -- most of their share gains really have been driven in Managed Medicaid.

我認為就 Admelog 而言，我認為重要的是要反映出他們的大部分份額收益確實是由託管醫療補助推動的。

Outside, when you look at Humalog outside of Managed Medicaid, our overall scripts are basically flat.

在外部，當您查看託管醫療補助之外的 Humalog 時，我們的整體腳本基本上是平的。

Clearly, there's an evolving landscape when it comes to insulins with the potential entry of other insulins follow-ons.

顯然，當涉及到其他胰島素後續產品的潛在進入時，胰島素的格局正在不斷發展。

As you know, the insulin categories are going to be transitioning to BLAs in the 2020 time frame.

如您所知，胰島素類別將在 2020 年時間框架內過渡到 BLA。

Clearly, there's questions about interchangeability and when is that going to play out.

顯然，存在關於可互換性的問題，以及何時會發揮作用。

As we said in the past, we don't view interchangeability as something imminent.

正如我們過去所說，我們並不認為可互換性是迫在眉睫的事情。

We eventually think this is going to happen, but there needs to be more clarity.

我們最終認為這會發生，但需要更加明確。

So this is likely something that won't happen before 2021.

所以這很可能在 2021 年之前不會發生。

Now it's difficult for us to predict when insulin follow-ons will come into the market in particular in the U.S. given that some of these product have expressed certain expectation when it comes to launch time lines but have been delayed.

現在我們很難預測胰島素後續產品何時會進入市場，尤其是在美國，因為其中一些產品在發佈時間線方面表達了一定的期望，但被推遲了。

Importantly to note as well is we continue to evolve our overall insulin strategy.

還需要注意的重要一點是，我們將繼續發展我們的整體胰島素戰略。

And we like to say that we are reimagining insulin systems and insulin delivery by basically bringing a Connected Care platforms to be able to grow patient outcomes in a much more meaningful way.

我們想說的是，我們正在重新構想胰島素系統和胰島素輸送，基本上帶來了一個 Connected Care 平台，以便能夠以更有意義的方式提高患者的治療效果。

So we're excited about our overall innovations with systems Connected Care but also bringing new insulins like our Ultra Rapid insulin Lispro that we're developing.

因此，我們對 Connected Care 系統的整體創新感到興奮，同時也帶來了新的胰島素，例如我們正在開發的 Ultra Rapid 胰島素 Lispro。

Thanks, Enrique.

謝謝，恩里克。

Dan?

擔？

Yes.

是的。

Thanks for the question on our ERK inhibitor.

感謝您提出關於我們的 ERK 抑製劑的問題。

This is a Phase I program, but it's still very early, but we're still pretty excited about it.

這是一個第一階段的計劃，但現在還很早，但我們仍然對此感到非常興奮。

The reason that we're excited about this pathway is because the MAP kinase pathway is implicated in driving about 30% of solid tumors.

我們對這條通路感到興奮的原因是 MAP 激酶通路與驅動約 30% 的實體瘤有關。

So it's a great opportunity to drive that pathway.

因此，這是推動這條道路的絕佳機會。

At ASCO, we have a couple of presentations on the ERK inhibitor, including some of the early Phase 1 data in a variety of patients and some data in lung cancer patients as well.

在 ASCO，我們有幾場關於 ERK 抑製劑的演講，包括一些在各種患者中的早期 1 期數據，以及在肺癌患者中的一些數據。

So we look forward to being able to share that, but again, it's an early program.

因此，我們期待能夠分享這一點，但同樣，這是一個早期計劃。

I think we have a few other disclosures at ASCO that we're excited about.

我認為我們對 ASCO 的其他一些披露感到興奮。

I'll turn it over to Anne to comment on a late-phase disclosure.

我會把它交給安妮來評論後期披露。

Yes.

是的。

So one of the disclosures that we're very excited about at ASCO is the results of our EGFR mutation-positive first-line lung cancer study in CYRAMZA, so this is the RELAY study.

因此，我們在 ASCO 非常興奮的披露之一是我們在 CYRAMZA 進行的 EGFR 突變陽性一線肺癌研究的結果，所以這是 RELAY 研究。

And we shared top line data in March that the study was positive and met the primary endpoint of progression-free survival.

我們在 3 月份分享了該研究是積極的並且達到了無進展生存期的主要終點的一線數據。

So we will be submitting to regulators globally midyear.

因此，我們將在年中向全球監管機構提交申請。

And approval on this would make the sixth indication that we've achieved for CYRAMZA.

對此的批准將成為我們為 CYRAMZA 取得的第六個跡象。

Importantly, we're excited about the data, and we look forward to this oral presentation at ASCO.

重要的是，我們對這些數據感到興奮，我們期待在 ASCO 上進行這次口頭報告。

Osimertinib is currently the standard of care in this setting, and we know that our magnitude of benefits must be competitive with that.

奧希替尼目前是這種情況下的護理標準，我們知道我們的利益幅度必須與之競爭。

We look forward to providing more answers for patients in this setting and also providing more options for physicians as they look to sequence therapy for the best outcomes for their patients.

我們期待在這種情況下為患者提供更多答案，並為醫生提供更多選擇，因為他們希望對患者進行排序治療以獲得最佳結果。

So we look forward to sharing more with you at ASCO.

因此，我們期待在 ASCO 與您分享更多信息。

Next, we'll go to Tim Anderson with Wolfe.

接下來，我們將和沃爾夫一起去蒂姆安德森。

On the REWIND data for Trulicity coming up at ADA, without -- before earning the data, can you just talk about your level of excitement?

關於即將在 ADA 上發布的 Trulicity 的 REWIND 數據，在沒有獲得數據之前，你能談談你的興奮程度嗎？

And if this is data where once it's presented, do you think the prescriber community is going to say, "Wow, that's really a game changer."?

如果這是一旦呈現出來的數據，你認為開處方者社區會說，“哇，這真的改變了遊戲規則。”？

And then second question on tanezumab.

然後是關於 tanezumab 的第二個問題。

I think a lot of investors feel this program is probably dead based on the Lilly's data disclosure from you and Pfizer.

根據禮來公司和輝瑞公司披露的數據，我認為很多投資者認為這個計劃可能已經死了。

Can you just share your perspective?

你能分享你的觀點嗎？

Yes.

是的。

So we'll go to Enrique on REWIND.

所以我們會在 REWIND 上去找恩里克。

And then Dan, that's if you want to talk about the tanezumab results.

然後丹，如果你想談談 tanezumab 結果。

Yes.

是的。

We continue to be excited about the REWIND results for Trulicity.

我們繼續對 Trulicity 的 REWIND 結果感到興奮。

I'm going to -- I have a plug here for my investor relations colleagues that we have an investor -- we're planning on an investor call at the ADA post the disclosure of the REWIND results, so we hope to either see you there or hope that you can either connect or be there in person.

我要 - 我在這里為我的投資者關係同事提供一個插件，我們有一個投資者 - 我們計劃在披露 REWIND 結果後在 ADA 上進行投資者電話會議，所以我們希望能見到你那里或希望您可以聯繫或親自到那裡。

Thank you.

謝謝你。

Dan?

擔？

Great.

偉大的。

Thanks for the question on tanezumab.

感謝有關 tanezumab 的問題。

Before I address your question on the future of tanezumab, I think it's important to comment on why we entered into this partnership with Pfizer and why we have pursued this program.

在我回答您關於 tanezumab 未來的問題之前，我認為重要的是要評論一下我們為什麼與輝瑞建立這種合作夥伴關係以及我們為什麼要開展這個項目。

It's obviously because of the dramatic unmet medical need here.

這顯然是因為這裡巨大的未滿足的醫療需求。

There are nearly 60 million Americans suffering with chronic pain from osteoarthritis and chronic lower back pain, many of whom have moderate to severe disease and aren't getting relief from currently available therapies.

有近 6000 萬美國人因骨關節炎和慢性腰痛而遭受慢性疼痛，其中許多人患有中度至重度疾病，並且無法從目前可用的治療中得到緩解。

When you put that in the context of the drawbacks of the therapies that are currently available, including, in many cases, opioids, you can just understand how important it is to have new non-opioid mechanisms to address pain.

當您將其置於當前可用療法（在許多情況下包括阿片類藥物）的缺點的背景下時，您就會明白擁有新的非阿片類藥物機制來解決疼痛是多麼重要。

So that's why we entered into this program.

所以這就是我們加入這個項目的原因。

And as we said before, we entered in with a high level of confidence on the efficacy of this mechanism.

正如我們之前所說，我們對這一機制的有效性充滿信心。

But what we saw to discharge was a safety risk through this program.

但我們看到通過該計劃釋放的是安全風險。

And so that brings us to the final study, which, of course, was designed to fully understand the safety risk of this mechanism.

因此，我們進入了最終研究，當然，該研究旨在充分了解這種機制的安全風險。

But that recent study enrolled a different population of patients than we enrolled in the others.

但最近的研究招募的患者群體與我們招募的其他患者不同。

We wanted to compare it to end-stage, and therefore, we had to enroll patients who were getting some measure of relief and can tolerate chronic NSAIDs.

我們想將其與終末期進行比較，因此，我們必須招募那些獲得一定程度緩解並且可以耐受慢性非甾體抗炎藥的患者。

So we're continuing to analyze the results from that study from 1058.

因此，我們將繼續分析 1058 年的研究結果。

We're looking at that, though, in the context of all of the available data on tanezumab.

不過，我們正在根據有關 tanezumab 的所有可用數據來研究這一點。

Our plan then is to discuss the totality of the data with regulators in the coming months.

我們的計劃是在未來幾個月與監管機構討論全部數據。

And that will help us decide on what the next steps are, and then we'll be able to share an update with you when that's going.

這將幫助我們決定接下來的步驟，然後我們將能夠在進行時與您分享更新。

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 行。

For Dan on Olumiant and atopic derm, what do you guys see as differentiation in the data so far among the JAKs?

對於 Olumiant 和特應性皮膚上的 Dan，你們認為迄今為止 JAK 之間的數據差異是什麼？

I know you still have data coming up.

我知道你還有數據。

And in this indication is your review from the field how attractive oral options are versus injectables.

在這個跡像中，您從該領域回顧了口服選擇與註射劑相比的吸引力。

And then just a real quick one for Enrique.

然後對恩里克來說是一個真正的快速。

In Trulicity, just want to ask your view on the class growth differences in the U.S. versus OUS, and how durable this is.

在 Trulicity 中，只想問您對美國與 OUS 的階級增長差異的看法，以及這種差異的持久性。

I know this has been a big driver, independent of the share gains that Trulicity has gotten over the years.

我知道這是一個很大的推動力，與 Trulicity 多年來獲得的份額無關。

Thanks, Geoff.

謝謝，傑夫。

So Dan, and then we'll go to Enrique.

所以丹，然後我們會去恩里克。

Okay.

好的。

Well, maybe I'll start with a comment on differentiation and toss it to Christi for the commercial insights on patient interest and in oral here.

好吧，也許我會從對差異化的評論開始，然後把它扔給克里斯蒂，以獲得關於患者興趣和口頭的商業見解。

Although I should just say it's premature to speculate on differentiation versus other molecules where we haven't seen the full data from theirs or even ours, but we're excited about the opportunity to be first here in atopic derm.

雖然我應該說現在推測與其他分子的分化還為時過早，我們還沒有看到他們甚至我們的完整數據，但我們很高興有機會在特應性皮膚中成為第一個。

Christi?

克里斯蒂?

Yes.

是的。

Exactly.

確切地。

Right now, DUPIXENT is available, but it's just an injectable for the more severe type of atopic derm, and there's so many more patients out there suffering, millions of patients.

現在，DUPIXENT 是可用的，但它只是一種針對更嚴重類型的特應性皮膚的注射劑，還有更多的患者在受苦，數以百萬計的患者。

In fact, our dermatologists tell us that atopic derm space reminds them of the psoriasis space about 15, 20 years ago.

事實上，我們的皮膚科醫生告訴我們，特應性皮膚空間讓他們想起了大約 15、20 年前的牛皮癬空間。

So we do think it's a large opportunity, and we do plan to be the first to act to market.

所以我們確實認為這是一個巨大的機會，我們確實計劃成為第一個向市場採取行動的人。

We released the fact that our first 2 studies were positive.

我們公佈了我們的前兩項研究是積極的事實。

You probably saw that.

你可能看到了。

We have 3 more studies to read out this year.

今年我們還有 3 項研究要宣讀。

And then based on the totality of that data, if they continue to be positive, we'll be submitting next year.

然後根據這些數據的整體，如果它們繼續是積極的，我們將在明年提交。

Thank you, Christi.

謝謝你，克里斯蒂。

Enrique?

恩里克?

So when it comes to Trulicity class or GLP-1 class growth, I think we see the same dynamics in most markets.

因此，當談到 Trulicity 類或 GLP-1 類增長時，我認為我們在大多數市場看到了相同的動態。

The drivers are similar, which is the updated guidelines that having recently released.

驅動程序類似，這是最近發布的更新指南。

So when we look outside of U.S., we are -- GLP-1 class growth is in the mid-20s.

因此，當我們放眼美國以外的地區時，我們 - GLP-1 類的增長處於 20 年代中期。

Given the majority of the class in the U.S., it is impressive that the growth in the U.S. is even higher than that, but it's very exciting to see.

鑑於美國的大多數班級，令人印象深刻的是美國的增長甚至更高，但看到這一點非常令人興奮。

And as a corollary to that, I think Trulicity's performance is very consistent across many markets.

作為推論，我認為 Trulicity 的表現在許多市場上都非常一致。

Next, we'll go to the line of Andrew Baum from Citi.

接下來，我們將轉到花旗的 Andrew Baum 的路線。

Just going back to SKYRIZI for the first question.

回到 SKYRIZI 來回答第一個問題。

What's your first-line market share for Taltz in psoriasis?

Taltz 在銀屑病領域的一線市場份額是多少？

And do you expect to be able to grow it now that SKYRIZI has been introduced into the market?

既然 SKYRIZI 已被引入市場，您是否期望能夠發展它？

I'm obviously referencing AbbVie's payer influence as well as the profile of that drug and what it may mean for the contraction of the more refractory line of therapy.

我顯然是在參考艾伯維（AbbVie）的付款人影響以及該藥物的概況以及它對更難治性治療線的收縮可能意味著什麼。

And then second, perhaps, Dave could comment on the timing and the impact of the proposed rebate reform on your diabetes business, especially on the near-term impact for realized pricing because of the Medicare math, assuming it does get implemented at the beginning of next year.

其次，也許戴夫可以評論提議的回扣改革對您的糖尿病業務的時機和影響，特別是假設它確實在開始時實施，由於醫療保險數學對實現定價的近期影響明年。

Thanks, Andrew.

謝謝，安德魯。

So we'll go to Christi for the comment on SKYRIZI.

因此，我們將前往 Christi 徵求對 SKYRIZI 的評論。

And then, Enrique, if you want to talk about the impact on diabetes for the proposed rebate safe harbor rule.

然後，恩里克，如果你想談談提議的退稅安全港規則對糖尿病的影響。

Yes.

是的。

So in dermatology specifically, our total prescriptions are a little over 15%, and we do see growth continuing, absolutely.

因此，特別是在皮膚病學方面，我們的總處方量略高於 15%，而且我們確實看到了持續增長，絕對是。

We see actually with the new therapies that have come to market, it actually has increased the market growth.

我們實際上看到，隨著新療法的上市，它實際上增加了市場增長。

So right now, the market is growing at 13%.

所以現在，市場正在以 13% 的速度增長。

And the more the newer agents come to market, I think the more you'll see the older TNFs be used for shorter periods of time or potentially not used first line in the future.

而且越新的藥物進入市場，我認為你會越多地看到舊的 TNF 被使用更短的時間，或者將來可能不會在一線使用。

And so we do see our growth coming from the fact also our ability to compete in dermatology, so the Tremfya versus Taltz head-to-head will be another place for us to go 5-year data sustained efficacy.

因此，我們確實看到我們的增長來自於我們在皮膚病學領域的競爭能力，因此 Tremfya 與 Taltz 的正面交鋒將是我們獲得 5 年數據持續療效的另一個地方。

And we really are the only one that's been able to show not only clear PASI 100 but the ability to do it fast in 1 to 2 weeks and that sustainability.

我們真的是唯一一個不僅能夠展示出清晰的 PASI 100，而且能夠在 1 到 2 週內快速完成並具有可持續性的能力。

So our growth continues, and we continue to have very high confidence that, that growth will continue.

因此，我們的增長仍在繼續，我們仍然非常有信心，這種增長將繼續下去。

Enrique?

恩里克?

The biggest impact from the -- on proposed rebate rule is really at the patient level because patients will have access to medicines at more affordable prices.

提議的回扣規則的最大影響實際上是在患者層面，因為患者將以更實惠的價格獲得藥物。

And if you think that threat forward, I think what you will basically see is better adherence, and I think that's something that we all want when it comes to health care, which is better adherence to medicines.

如果你認為這種威脅是前進的，我認為你基本上會看到更好的依從性，我認為這是我們在醫療保健方面都想要的東西，那就是更好地遵守藥物。

So the impact that is not often talked about is really when it comes to maybe an impact on volume.

因此，不經常談論的影響實際上是對音量的影響。

When it comes to some of the mechanics and so forth, honestly, I view it pretty neutral overall.

當談到一些機制等等時，老實說，我認為它總體上是中性的。

Let me just jump in, Andrew, on maybe both those points.

安德魯，讓我就這兩點進行討論。

I think it's important to note in psoriasis, 2 things: one, that there's 4-step into TNFs for almost every patient.

我認為在牛皮癬中需要注意兩件事：第一，幾乎每個患者都有 4 步進入 TNF。

If that were to change, I think that's a big positive for the newer innovations, so the doctors could select appropriate therapy for patients with psoriasis, noting that TNFs don't work nearly as well as the new classes, and amongst those, we think Taltz is the best profile.

如果這種情況發生改變，我認為這對新的創新來說是一個很大的積極因素，因此醫生可以為銀屑病患者選擇合適的治療方法，並指出 TNF 的效果不如新類別，其中我們認為Taltz 是最好的配置文件。

Also within derm, there's a lot of switching anyway, so the front-line market is -- versus the total is much smaller than other immunology indications.

同樣在真皮內，無論如何都有很多轉換，所以一線市場 - 與總數相比，比其他免疫學適應症要小得多。

That's an important thing to keep in mind.

記住這一點很重要。

On the rebate rule, we do -- we are planning for implementation January 1. I think Enrique rightly notes the volume upside.

關於回扣規則，我們確實 - 我們計劃在 1 月 1 日實施。我認為 Enrique 正確地註意到了交易量的上漲。

The thing one would worry about is rate compression because, presumably, you'd have more facial and transparent pricing, but I think across our portfolios, because of the high consolidation on the payer side, the rates are pretty compressed already.

人們會擔心的是費率壓縮，因為大概，你會有更多的表面和透明的定價，但我認為在我們的投資組合中，由於支付方的高度整合，費率已經相當壓縮了。

There aren't big differences between what the payers are paying.

付款人支付的費用沒有太大差異。

So that's why we lean into this one.

所以這就是為什麼我們傾向於這個。

We think it's the right policy answer to help seniors with medication costs and to shift the debate from list pricing to net pricing, which we see is our long-term interest.

我們認為，幫助老年人支付藥物費用並將辯論從定價轉向淨定價是我們的長期利益，這是正確的政策答案。

We'll go to Vamil Divan from Crédit Suisse.

我們會去瑞士信貸的 Vamil Divan。

So just first on Olumiant, I think I asked this question before.

所以首先在 Olumiant 上，我想我之前問過這個問題。

But just the U.S. opportunity there against our limited sales this quarter, I think you said in your prepared remarks you're not going to be filing for psoriatic arthritis.

但只是美國的機會反對我們本季度的有限銷售，我想你在準備好的評論中說過你不會申請銀屑病關節炎。

Just correct me if I misheard that.

如果我聽錯了，請糾正我。

And then I'm just trying to get a sense of how you think about getting the 4 milligrams to the market and sort of the opportunity in the U.S. with that product and also the implications from the data Pfizer recently released from their long-term trial, showing some additional questions around thrombosis.

然後我只是想了解您如何看待將 4 毫克推向市場，以及該產品在美國的機會，以及輝瑞公司最近發布的長期試驗數據的影響，顯示有關血栓形成的一些其他問題。

And then the second one, just following up on the psoriasis questions.

然後是第二個，只是跟進牛皮癬問題。

You mentioned mirikizumab and the data there in psoriasis.

您提到了 mirikizumab 和銀屑病中的數據。

I know you said you'd be first in GI.

我知道你說過你會成為 GI 的第一名。

I'm just curious what the differentiation, if any, would be in psoriasis for that product.

我只是好奇該產品在牛皮癬中的差異（如果有的話）。

Or does it relate more just from a GI focus as we think about?

還是正如我們所想的那樣，它是否僅與 GI 關注點相關？

Thanks, Vamil.

謝謝，瓦米爾。

We'll go to Christi for Olumiant mirikizumab questions.

我們將去克里斯蒂詢問 Olumiant mirikizumab 的問題。

Okay.

好的。

So for Olumiant, yes, I think what we see in the U.S. is it will be slow and steady in Olumiant 2 milligrams RA.

所以對於 Olumiant，是的，我認為我們在美國看到的是，在 Olumiant 2 毫克 RA 中它會緩慢而穩定。

Your question about psoriatic arthritis, you did hear correctly.

你關於銀屑病關節炎的問題，你沒聽錯。

As we look at the opportunities for us to be best-in-class, first-in-class and really enter market with unmet need, in psoriatic arthritis and the ankylosing spondylitis nonradiographic AxSpA as well, we already have Taltz, and Taltz has shown very remarkable results.

當我們看到機會讓我們成為一流、一流並真正以未滿足的需求進入市場時，在銀屑病關節炎和強直性脊柱炎非放射 AxSpA 領域，我們已經擁有 Taltz，Taltz 已經證明非常顯著的結果。

And so we feel very good with that play as we look to study Olumiant and other indications like atopic dermatitis.

因此，當我們希望研究 Olumiant 和其他適應症（如特應性皮炎）時，我們對這部劇感覺非常好。

Remember, lupus got fast track designation in December.

請記住，狼瘡在 12 月獲得了快速通道指定。

We are studying both 2 and 4 milligrams in that indication as well as atopic dermatitis.

我們正在研究該適應症中的 2 和 4 毫克以及特應性皮炎。

And we have our alopecia areata study where Phase II will read out later this year and, if positive, will move to Phase III.

我們有我們的斑禿研究，第二階段將在今年晚些時候宣讀，如果是陽性，將進入第三階段。

So we're still very big on the opportunity of baricitinib as a whole.

所以我們仍然非常看好巴瑞替尼作為一個整體的機會。

The RA 2 milligrams will be slow and steady growth, and 4 milligrams is being studied, and we look to see the efficacy results there and bring it to market if they're positive.

RA 2 毫克將緩慢而穩定地增長，4 毫克正在研究中，我們希望在那裡看到療效結果，如果它們是積極的，我們將把它推向市場。

In regards to the Pfizer question about what readout on their JAK high dose, so we -- as we look at the data that we have in 55 countries that have approved Olumiant, we haven't seen unusual safety signals in DTEs.

關于輝瑞公司關於其 JAK 高劑量讀數的問題，因此，當我們查看已批准 Olumiant 的 55 個國家/地區的數據時，我們沒有在 DTE 中看到異常的安全信號。

And we continue to study.

我們繼續研究。

Obviously, post-marketing research that we're doing in collaboration with the agreement with FDA both on real-world evidence and in randomized clinical trial, those will continue as well.

顯然，我們與 FDA 就真實世界證據和隨機臨床試驗的協議合作進行的上市後研究，這些研究也將繼續進行。

So no news on -- no unusual news on our side on Olumiant like the Pfizer announcement.

所以沒有消息——在我們這邊沒有像輝瑞公告這樣的關於 Olumiant 的不尋常消息。

And then lastly, on mirikizumab.

最後，關於mirikizumab。

So yes, we're in Phase III studies with both psoriasis and ulcerative colitis.

所以是的，我們正在進行銀屑病和潰瘍性結腸炎的 III 期研究。

We are very excited about the GI space because mirikizumab should be the first IL-23 to ulcerative colitis.

我們對 GI 領域感到非常興奮，因為 mirikizumab 應該是潰瘍性結腸炎的第一個 IL-23。

We also finished our Phase II data on Crohn's disease.

我們還完成了關於克羅恩病的 II 期數據。

That data will be released at DDW in just a few weeks here in May, so look for that.

該數據將在 5 月份的幾週內在 DDW 上發布，所以請尋找。

And then, yes, in psoriasis, we are doing a Phase III clinical trial with some competitive endpoints and head-to-head data.

然後，是的，在銀屑病方面，我們正在進行一項 III 期臨床試驗，其中包含一些競爭性終點和頭對頭數據。

So when that study reads out, we'll be looking to see if we're going to have stronger and more sustained results than current IL-23s on that market.

因此，當該研究公佈時，我們將看看我們是否會比該市場上目前的 IL-23 獲得更強大和更持久的結果。

Next, we'll go to Umer Raffat from Evercore.

接下來，我們將從 Evercore 前往 Umer Raffat。

First, can you quantify for us what percentage of TRx are paid versus free on Taltz as well as Emgality?

首先，您能否為我們量化 Taltz 和 Emgality 上付費與免費的 TRx 百分比？

And secondly, I noticed one of the trials reading out for you this fall, the IL-10 plus Opdivo trial in second-line lung, has been shrunk from 100 down to 50 patients.

其次，我注意到今年秋天為您宣讀的一項試驗，IL-10 plus Opdivo 二線肺試驗已從 100 名患者減少到 50 名患者。

Is that simply a function of increasing Keytruda use in first line?

這僅僅是增加 Keytruda 在第一線使用的功能嗎？

Or is there another dynamic here as well?

還是這裡還有另一種動態？

Okay.

好的。

Thank you.

謝謝你。

We'll go to Christi for the questions around Taltz and Emgality.

我們將去克里斯蒂詢問有關 Taltz 和 Emgality 的問題。

And then Anne will talk about pegilodecakin.

然後安妮將談論 pegilodecakin。

Sure.

當然。

First of all, Lilly believes in really open access and giving choice to patients and physicians, so we continue to work with payers on access with Taltz.

首先，禮來（Lilly）相信真正的開放獲取並為患者和醫生提供選擇，因此我們繼續與付款人合作使用 Taltz 獲取。

In spite of that, we -- the barriers that we've had, we've had very good uptake with Taltz.

儘管如此，我們 - 我們遇到的障礙，我們對 Taltz 的接受度非常好。

And as we look at our programs, patient-specific copay card, et cetera, being able to allow patients on drug and then transition to insurance coverage, we see that 2/3 of patients in the market on Taltz are paid for.

當我們查看我們的計劃、特定於患者的共付卡等，能夠讓患者接受藥物治療然後過渡到保險範圍時，我們看到 Taltz 市場上 2/3 的患者是付費的。

On Emgality, as I said before, the commercial claims that have been submitted, we see in Q1 that 57% of those have been reimbursed.

正如我之前所說，在 Emgality 上，已提交的商業索賠，我們在第一季度看到其中 57% 已得到報銷。

And as we exited Q1, we saw that in the mid-60s, 2 out of every 3 patients that submitted a claim, we had reimbursed coverage for.

當我們退出第一季度時，我們看到在 60 年代中期，每 3 名提交索賠的患者中就有 2 名獲得了報銷。

Thanks, Christi.

謝謝，克里斯蒂。

Anne?

安妮？

Yes.

是的。

On the question on pegilodecakin, this is the Cypress 2 study you're referring to, so this is the second-line lung study -- Phase II study in IO-naive patients, so following first-line treatment but not in immunotherapy.

關於 pegilodecakin 的問題，這是您所指的 Cypress 2 研究，所以這是二線肺部研究——在 IO 初治患者中進行的 II 期研究，因此在一線治療後但不在免疫治療中。

And then it's in combination with Opdivo in low expressors.

然後在低表達量中與 Opdivo 結合使用。

And what we're finding, as you know well, is it that IO-naive patients in the second line are becoming increasingly rare.

如您所知，我們發現的是，二線中未接受過 IO 的患者越來越少。

So what we decided to do was analyze that data and have that informed the next step for the program but not continue to further enroll patients in this somewhat diminishing population.

所以我們決定做的是分析這些數據，並為該計劃的下一步提供信息，但不會繼續在這個逐漸減少的人群中進一步招募患者。

We have remained confident that the greatest opportunities for pegilodecakin remain in lung cancer both on the first-line setting and then later line and also in renal cell cancer.

我們仍然相信，pegilodecakin 的最大機會仍然存在於肺癌中，無論是一線治療，還是後期治療，以及腎細胞癌。

So as Dan mentioned, we'll be starting a renal cell study later this year, but we look forward to read-outs in lung at the end of this year and then also in pancreatic cancer early next year and remain confident in the opportunities for pegilodecakin across those tumor types.

所以正如 Dan 提到的，我們將在今年晚些時候開始一項腎細胞研究，但我們期待在今年年底對肺部進行讀數，然後在明年初也對胰腺癌進行讀數，並對機會保持信心pegilodecakin 跨越這些腫瘤類型。

So look forward to hearing more towards the end of the year both on Cypress 2 and on the Cypress 1 study, which is in the first-line setting.

因此，期待在今年年底聽到更多關於 Cypress 2 和 Cypress 1 研究的更多信息，該研究處於一線環境中。

We'll go to David Risinger, Morgan Stanley.

我們將前往摩根士丹利的 David Risinger。

I have 2 questions.

我有 2 個問題。

The first is for Dave.

第一個是給戴夫的。

I'm hoping that you can help us understand a little bit better how you're thinking about the forthcoming HHS action on the elimination of rebates and how that will negatively impact companies that use volume-based discounts such that a product like Taltz will be able to step up on the formulary and maybe move into a formulary position that another larger player held in psoriasis.

我希望你能幫助我們更好地理解你是如何考慮 HHS 即將採取的關於取消回扣的行動，以及這將如何對使用基於數量的折扣的公司產生負面影響，這樣像 Taltz 這樣的產品將是能夠加強處方，並可能進入另一位較大的牛皮癬患者所持有的處方位置。

And then second, Enrique, with respect to Trulicity, just hoping that you can help us with a little bit more of a bridge.

其次，Enrique，關於 Trulicity，只是希望你能幫助我們多一點橋樑。

So you said that Rx increased sequentially by 5% to 6%.

所以你說 Rx 依次增加了 5% 到 6%。

Actual shipments declined by 7%.

實際出貨量下降了 7%。

So does that mean there was an inventory work-down of 12% to 13%?

那麼這是否意味著庫存減少了 12% 到 13%？

And could you also quantify the negative dollar change in reserves?

你能否量化美元儲備的負變化？

Thank you.

謝謝你。

Dave and then Enrique.

戴夫，然後是恩里克。

Yes.

是的。

Thanks, Dave.

謝謝，戴夫。

So on the rebate rule, again, we are planning for this January 1. Of course, it's Part D, there are some legislative efforts to look at regulating commercial market.

因此，關於回扣規則，我們再次計劃在今年 1 月 1 日。當然，這是 D 部分，有一些立法努力著眼於規範商業市場。

I guess at this point, my speculation would be that looks more challenging either for political or practical reasons.

我想在這一點上，我的猜測是，出於政治或實際原因，這看起來更具挑戰性。

But I do think once Part D changes, and I think we're, as I said, planning towards that, you will start to see increased interest from payers that are not -- the government systems or commercial payers to have similar benefits provided that there are beneficiaries, particularly in chronic disease where list price effects have cleared a lot of distortion and increased out-of-pocket costs.

但我確實認為，一旦 D 部分發生變化，並且我認為正如我所說的那樣，我們正在為此計劃，您將開始看到非支付者的興趣增加——政府系統或商業支付者將獲得類似的好處，前提是有受益者，特別是在慢性病領域，定價效應消除了很多扭曲並增加了自付費用。

So we've all heard the outcry around that really centered on insulin, frankly.

因此，坦率地說，我們都聽到了圍繞真正以胰島素為中心的強烈抗議。

So I think your logic is the right one in the sense that today, with rebates, which are not shared with patients and confidential payers have a strong incentive to keep those confidential and use those to compete on premiums, that's the way it works.

所以我認為你的邏輯是正確的，因為今天，回扣不與患者分享，保密的付款人有強烈的動機去保密並利用這些來競爭保費，這就是它的運作方式。

I think in a future world where that can't be the way they can use those rebates, they'll need to compete for premiums in other ways, efficiency, presumably, and patients who have a choice at the counter based on net pricing.

我認為在未來的世界裡，他們不能使用這些回扣，他們需要以其他方式競爭保費，大概是效率，以及根據淨定價在櫃檯有選擇的患者。

I would assume that doctors are informed about those net prices, and that also becomes an influencer on prescribing.

我會假設醫生會了解這些淨價格，這也會成為處方的影響因素。

So for new innovative therapies, hypothetically, one in a specialty market or in a general practitioner market like Emgality, I think that will be an important part of any company strategy to understand the net price that officially be there for the consumer.

因此，對於新的創新療法，假設是在專業市場或像 Emgality 這樣的全科醫生市場，我認為這將是任何公司戰略的重要組成部分，以了解正式面向消費者的淨價格。

The final comment is, of course, Part D is a senior program, so the demographics will affect us mostly in our diabetes franchise initially, and that's where a lot of our planning is focused right now.

最後的評論是，當然，D 部分是一個高級項目，所以人口統計數據最初將主要影響我們的糖尿病專營權，而這正是我們現在很多計劃的重點。

Thanks, Dave.

謝謝，戴夫。

Enrique?

恩里克?

Whenever we look at sequential growth, you -- there's what I call the colloquially a double whammy effect.

每當我們看到連續增長時，你——這就是我所說的通俗的雙重打擊效應。

We could be dollar counting here.

我們可以在這里數美元。

It doesn't simply add up.

它不是簡單的加起來。

One good way to think about it is just if we were to shift 5% of the units from Q4 to Q1, that explains 10 percentage points of difference.

考慮它的一種好方法是，如果我們將 5% 的單位從第四季度轉移到第一季度，這就解釋了 10 個百分點的差異。

But in reality, you're only shipping 5% of units from 1 quarter to the -- to another.

但實際上，您僅將 5% 的產品從第一季度運送到另一個季度。

That's a long way of saying that I would have your estimate likely the -- we don't have full visibility into the retail inventories, but my assessment is about 6 points.

很長的一段話，我可能會得到你的估計——我們對零售庫存沒有完全的了解，但我的估計大約是 6 分。

Next, we'll go to Steve Scala from Cowen.

接下來，我們將介紹 Cowen 的 Steve Scala。

I have a couple of questions.

我有一些問題。

We were expecting Verzenio data in 2019 from monarchHER and MONARCH plus.

我們期待 2019 年來自 monarchHER 和 MONARCH plus 的 Verzenio 數據。

I'm wondering if they're still on track.

我想知道他們是否還在軌道上。

And then secondly, Enrique, one of the concerns with the upcoming REWIND readout is that the benefit might be driven by the 30% or so of patients in the trial with preexisting cardiovascular disease, and that the remaining patients add little to the overall outcome.

其次，恩里克（Enrique）對即將發布的 REWIND 讀數的擔憂之一是，試驗中 30% 左右的患者可能會帶來益處，這些患者之前患有心血管疾病，而其餘患者對整體結果的影響很小。

So overall, the benefit might be a solid but unspectacular 20%-or-so reduction in risk, which won't offer opportunity for differentiation.

因此，總體而言，收益可能是可靠但不引人注目的 20% 左右的風險降低，這不會提供差異化的機會。

Just wondering, can you tell us not to be concerned about this point?

只是想知道，你能告訴我們不要關心這一點嗎？

I will go to Anne for the question on Verzenio and then Enrique on REWIND.

我將在 Verzenio 上向 Anne 提問，然後在 REWIND 上向 Enrique 提問。

Yes.

是的。

So you are correct.

所以你是對的。

So we're looking to deliver our new data to drive additional growth, and one of them is the HER2+ study, which we will report results on towards the end of the year at a medical meeting.

因此，我們正在尋求提供我們的新數據以推動額外的增長，其中之一是 HER2+ 研究，我們將在年底的醫學會議上報告結果。

The MONARCH 2 overall survival data will read out, as we had communicated in the past, in 2020.

正如我們過去所傳達的，MONARCH 2 的總體生存數據將在 2020 年讀出。

And then we also have, importantly, the Adjuvant study reading out in 2021.

然後，重要的是，我們還有 2021 年宣讀的輔助研究。

And I appreciate asking about Verzenio because there has been an encouraging start to the year.

我很高興詢問 Verzenio，因為今年的開局令人鼓舞。

The revenue grew 30% over Q4, and we also are seeing nice uptake across Japan and European markets.

收入比第四季度增長了 30%，我們也看到日本和歐洲市場的增長勢頭良好。

So look forward to these additional data readouts helping contribute to that message but look forward to those readouts coming as we had communicated in the past.

因此，期待這些額外的數據讀數有助於傳達這一信息，但也期待我們過去傳達的那些讀數。

Thanks, Anne.

謝謝，安妮。

Enrique?

恩里克?

We are unable to provide additional comments on REWIND, but look -- we look forward to seeing you at the conference call.

我們無法就 REWIND 提供更多評論，但請看——我們期待在電話會議上見到您。

Next, we'll go to the line of Alex Arfaei, BMO.

接下來，我們將轉到 BMO 的 Alex Arfaei 的線路。

On tirzepatide, your -- good to see the program formally, I guess, extended in obesity and NASH.

在 tirzepatide 上，我猜你很高興正式看到這個項目，它在肥胖和 NASH 方面得到了擴展。

Regarding your Phase III obesity trial, could you give us a little bit more color in terms of the outcomes you're looking for, the competitor you're using and the potential readout?

關於您的 III 期肥胖試驗，您能否就您正在尋找的結果、您正在使用的競爭對手和潛在的讀數給我們更多的色彩？

And you mentioned you'll have dose titration data at ADA.

您提到您將在 ADA 獲得劑量滴定數據。

Can you comment on the extent to which that data shape your dosing for the Phase III trials, particularly the high dose?

您能否評論這些數據在多大程度上影響了您在 III 期試驗中的劑量，尤其是高劑量？

Enrique?

恩里克?

Yes.

是的。

So we are very excited about tirzepatide and been able to start our Phase III type 2 diabetes study and basically pursuing both obesity in Phase III and NASH in Phase II.

因此，我們對 tirzepatide 感到非常興奮，並且能夠開始我們的 III 期 2 型糖尿病研究，並且基本上在 III 期追求肥胖症和在 II 期追求 NASH。

We are not providing additional color on the specific obesity trials that we're conducting -- that we're going to conduct.

我們不會為我們正在進行的特定肥胖試驗提供額外的顏色——我們將要進行的試驗。

Clearly, we need to have the appropriate discussions with the FDA as we engage in this Phase III trial.

顯然，在我們參與這項 III 期試驗時，我們需要與 FDA 進行適當的討論。

But we plan to do some time -- that some time in the future.

但我們計劃做一些時間——未來的某個時間。

And as far as the titration question, yes, we do plan to have presentation at ADA looking at some of the additional titration data for tirzepatide.

至於滴定問題，是的，我們確實計劃在 ADA 上展示一些關於 tirzepatide 的額外滴定數據。

Next, we'll go to Louise Chen, Cantor.

接下來，我們將前往 Cantor 的 Louise Chen。

So my first question is on mirikizumab.

所以我的第一個問題是關於mirikizumab。

You'd mentioned that you'll likely be the first IL-23 to market and you see in Crohn.

您曾提到您很可能是第一個上市的 IL-23，您會在克羅恩看到。

I'm just curious, in addition to that, what are the competitive advantages do you see as it relates to other ILs in development and also JAK?

我只是好奇，除此之外，您認為與其他開發中的 IL 以及 JAK 相關的競爭優勢是什麼？

And then, the second question I had was on, LOXO-292.

然後，我的第二個問題是關於 LOXO-292。

You showed very good ORR, median duration, percentage of patients on therapy.

您表現出非常好的 ORR、中位持續時間、接受治療的患者百分比。

How do you think that will hold up into the Phase II readout?

您認為這將如何影響第二階段的讀數？

And how do you think you might compare with other RET inhibitors in development?

您認為您如何與其他正在開發的 RET 抑製劑進行比較？

Thanks.

謝謝。

We'll go to Christi for mirikizumab and then Anne on RET inhibitor.

我們將去克里斯蒂（Christi）接受 mirikizumab，然後去安妮（Anne）接受 RET 抑製劑。

Thanks, Louise, for the question on miri.

謝謝，路易絲，關於米里的問題。

So to be clear, we expect to be first into the market on ulcerative colitis and first of a couple to market on Crohn's disease.

因此，需要明確的是，我們預計將首先進入潰瘍性結腸炎市場，並在一對夫婦中率先進入克羅恩病市場。

So you'll never know.

所以你永遠不會知道。

We've been speeding up the Phase II trial and look forward to the -- to entering the next, but that's where we are on GI.

我們一直在加快 II 期試驗，並期待進入下一個試驗階段，但這就是我們在 GI 上的位置。

We're very excited because our studies are set up to be a best-in-class.

我們非常興奮，因為我們的學習是一流的。

And so if they read out positively, we expect to not only be first-in-class but best-in-class in ulcerative colitis and Crohn's disease.

因此，如果他們的結果是積極的，我們預計不僅在潰瘍性結腸炎和克羅恩病方面是一流的，而且是一流的。

Thank you, Christi.

謝謝你，克里斯蒂。

Anne?

安妮？

Yes.

是的。

When we have thought on the LOXO question, when we start to move into a precision medicine and to obtain a RET inhibitor, we really thoroughly surveyed the landscape and selected the molecule on the portfolio that we believed to be first and best-in-class, and we continue to believe that today.

當我們思考 LOXO 問題時，當我們開始進入精準醫學並獲得 RET 抑製劑時，我們真的徹底調查了形勢並選擇了我們認為是第一和同類最佳的產品組合中的分子，我們今天仍然相信這一點。

We intend to submit in the U.S. by the end of the year and in Europe shortly thereafter.

我們打算在今年年底之前在美國提交，之後不久在歐洲提交。

So to answer your question, we remain very confident in the efficacy safety profile and the duration of our RET inhibitor, and we will continue to expect that we'll deliver first in both lung and thyroid cancer.

因此，為了回答您的問題，我們對我們的 RET 抑製劑的療效安全性和持續時間非常有信心，我們將繼續期待我們將首先在肺癌和甲狀腺癌中提供治療。

So we'll actually be having -- we're presenting an update on the registrational data in the second half of 2019 at a major -- a couple of major medical meetings in advance of that potential regulatory filing.

因此，在可能的監管備案之前，我們實際上將在 2019 年下半年在一次重大會議上介紹註冊數據的更新。

And importantly, as you look at this data set, we now have over 400 patients enrolled across tumor types of RET fusion or mutation.

重要的是，當您查看此數據集時，我們現在有超過 400 名患者參與了 RET 融合或突變的腫瘤類型。

And so we fully expect the data to continue to bear out what we saw last year, which is, in response to what you said, from 60% to 80% with well over 90% of patients remaining on studies.

因此，我們完全預計數據將繼續證實我們去年看到的情況，即根據你所說的，從 60% 到 80%，超過 90% 的患者仍在研究中。

This is the data reported last year, and then we'll provide an update later this year.

這是去年報告的數據，然後我們將在今年晚些時候提供更新。

(Operator Instructions) Next, we'll go to Navin Jacob from UBS.

（操作員說明）接下來，我們將前往 UBS 的 Navin Jacob。

So number one, I just want to -- I'm sorry to beat a dead horse on GLP-1 pricing, but Enrique, if you could just dig in a little bit further.

所以第一，我只是想 - 我很抱歉在 GLP-1 定價上打敗了一匹死馬，但是恩里克，如果你能再深入一點的話。

I just want to understand, in Q1 of this year, how much of the lower price was related to Medicare Part D, on whole changes versus other rebate-related changes?

我只是想了解，在今年第一季度，整體變化與其他與回扣相關的變化有多少與醫療保險 D 部分有關？

Because you mentioned that there was rebate estimate adjustments.

因為你提到有回扣估計調整。

I want to understand, is that a onetime impact for cool accounting-related issues?

我想了解，這對很酷的會計相關問題有一次性影響嗎？

Or is it something that we should be thinking about as continuing on going forward?

還是我們應該考慮繼續前進？

And so overall, just want to understand where is the GLP class going in terms of pricing?

總的來說，只是想了解 GLP 課程在定價方面的發展方向？

Is there going to be continued pricing pressure over the next couple of years?

未來幾年是否會持續存在定價壓力？

And then secondly, just on op margins, if you could help us understand longer term where the op margin profile for the human health business would look like.

其次，就運營利潤率而言，如果您能幫助我們了解長期來看，人類健康業務的運營利潤率概況會是什麼樣子。

Can we expect margins to reach mid- to high 30s, in line with some of your other peers?

我們能否期望利潤率達到 30 多歲的中高水平，與您的其他一些同行一樣？

I appreciate the help.

我很感激幫助。

Thanks, Navin.

謝謝，納文。

We'll go to Enrique for Trulicity and then Josh on the op margin questions.

我們將向 Enrique 詢問 Trulicity，然後向 Josh 詢問操作邊際問題。

Yes.

是的。

So I -- just first to address the question about the doughnut hole.

所以我——首先要解決關於甜甜圈洞的問題。

The donut hole becomes a little more important in Q2.

甜甜圈洞在第二季度變得更加重要。

I don't have the numbers in front of me, but I -- in the case of diabetes medicines, maybe Q1 is maybe only about 10% of the overall donut hole from an accounting perspective what we're going to see throughout the year.

我沒有擺在我面前的數字，但我 - 就糖尿病藥物而言，從會計角度來看，第一季度可能僅佔整個甜甜圈洞的 10% 左右，我們將在全年看到.

So when we think about Trulicity, while there was some impact of the donut hole, it was not material to the pricing result.

因此，當我們考慮 Trulicity 時，雖然甜甜圈洞有一些影響，但它對定價結果並不重要。

As we -- as I mentioned, when we look at Trulicity, we do have high rebates in managed care and so forth relative to Q1 of last year.

正如我們 - 正如我所提到的，當我們查看 Trulicity 時，相對於去年第一季度，我們在管理式醫療等方面確實有很高的回扣。

The change is due to estimates -- change in estimates for rebates and discounts, that -- yes, that is basically changing because of how we had accrued and based on a full review of the claim that we received later, basically changes the information that we have on hand, and we need to account for that as soon as we know that information.

變化是由於估計 - 回扣和折扣估計的變化 - 是的，這基本上是因為我們如何累積以及基於對我們後來收到的索賠的全面審查而發生的變化，基本上改變了以下信息我們手頭有，一旦我們知道這些信息，我們就需要考慮這一點。

So yes, that is a particular impact that was from other quarters that basically is impacting this particular quarter.

所以是的，這是來自其他季度的特殊影響，基本上影響了這個特定季度。

So that's probably as much details I can provide.

所以這可能是我能提供的盡可能多的細節。

Thanks, Enrique.

謝謝，恩里克。

Josh?

喬什？

Operating margins for the quarter, we were slightly above 26%.

本季度的營業利潤率略高於 26%。

Our guidance for the year is to be at 28%.

我們對今年的指導是 28%。

We're confident we'll get there.

我們有信心到達那裡。

I think you'll see through the remainder of the year that we'll see, prior guidance, top line growth netting out currency effects similar to what we're seeing this quarter, and we'll see sort of operating expenses at a more constant absolute level than what we're seeing in Q1.

我認為你會看到我們將看到的今年剩餘時間，之前的指導，頂線增長抵消了類似於我們本季度看到的貨幣效應，我們將看到某種運營費用在更高恆定的絕對水平比我們在第一季度看到的水平。

So we're confident in our 28% for the year.

因此，我們對今年的 28% 充滿信心。

And then for 2020, our goal is 31%.

然後到 2020 年，我們的目標是 31%。

We are confident as well in achieving that.

我們也有信心實現這一目標。

That's for pharma-only, so that's on our new basis excluding Elanco.

這僅適用於製藥公司，所以這是我們的新基礎，不包括 Elanco。

We see good opportunity to get to the 31%, so we're -- no change there.

我們看到了達到 31% 的好機會，所以我們沒有改變。

I think if you look past 2020, we'd expect margin expansion to continue.

我認為，如果您回顧 2020 年，我們預計利潤率將繼續擴大。

We have limited patent expirations in the first half of the next decade.

我們在未來十年的前五年限制了專利到期。

And we still have the new products that we're launching now, will still be in their growth phase.

而且我們仍然有我們現在推出的新產品，仍將處於增長階段。

So we'll definitely see margin expansion opportunities post 2020, but we haven't given a specific goal.

因此，我們肯定會在 2020 年後看到利潤率擴張的機會，但我們沒有給出具體目標。

There are no further questions in queue at this time.

目前隊列中沒有其他問題。

Dave Ricks, please go ahead.

戴夫·里克斯，請繼續。

All right.

好的。

Thank you.

謝謝你。

Thank you all for joining us.

感謝大家加入我們。

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

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。

We began 2019 with a lot of momentum and made meaningful progress in our first quarter.

我們在 2019 年開始時勢頭強勁，並在第一季度取得了有意義的進展。

Although Q1 was a period of investment, we remain committed to our revenue and profitability goals for 2019 and 2020.

儘管第一季度是投資期，但我們仍致力於實現 2019 年和 2020 年的收入和盈利目標。

We continue to advance our innovation-based strategy to progressing internally discovered medicines, augmented with external innovation.

我們繼續推進以創新為基礎的戰略，以發展內部發現的藥物，並輔以外部創新。

We completed 2 transformative transactions this quarter as well, with the full separation of Elanco and the addition of Loxo Oncology.

本季度我們還完成了 2 筆變革性交易，完全分離 Elanco 並增加了 Loxo Oncology。

With a robust pipeline and volume-driven revenue growth, Lilly continues to be a compelling investment.

憑藉強大的管道和銷量驅動的收入增長，禮來繼續成為一項引人注目的投資。

Thanks, again, for dialing in.

再次感謝您撥入。

Please follow-up with our IR team if you have additional questions that were not addressed on today's call.

如果您還有今天電話會議未解決的其他問題，請與我們的 IR 團隊聯繫。

Have a great day.

祝你有美好的一天。

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 Executive Teleconference.

感謝您的參與和使用 AT&T 行政電話會議。

You may now disconnect.

您現在可以斷開連接。