禮來公司 (LLY) 2019 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the quarter 2 2019 earnings call.

女士們，先生們，感謝你們的支持，歡迎來到 2019 年第二季度財報電話會議。

(Operator Instructions) And as a reminder, today's conference call is being recorded.

（操作員說明）作為提醒，今天的電話會議正在錄音中。

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

我現在想將會議轉交給投資者關係副總裁 Kevin Hern。

Please go ahead.

請繼續。

Good morning.

早上好。

Thank you for joining us for Eli Lilly and Company's Q2 2019 Earnings Call.

感謝您參加禮來公司 2019 年第二季度財報電話會議。

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; Anne White, President of Lilly Oncology; Enrique Conterno, President of Lilly Diabetes and Lilly USA; and Patrick Johnson, who is joining us for the first time as our incoming President of Lilly Bio-Medicines.

與我一起參加今天電話會議的還有禮來公司董事長兼首席執行官戴夫·里克斯（Dave Ricks）；我們的首席財務官 Josh Smiley；禮來研究實驗室總裁 Dan Skovronsky 博士；禮來腫瘤學總裁 Anne White； Enrique Conterno，禮來糖尿病和禮來美國公司總裁；還有帕特里克·約翰遜，他將首次加入我們，擔任禮來生物醫藥的新任總裁。

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 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原則財務指標上，其中不包括 Elanco 在 2018 年和 2019 年的財務貢獻，並呈現每股收益，就好像通過交換要約完成的全部處置一樣2018 年 1 月 1 日。

Now I'll turn the call over to Dave for a summary of our progress in Q2.

現在，我將把電話轉給 Dave，以總結我們在第二季度的進展。

Thanks, Kevin.

謝謝，凱文。

Both an exciting morning for us here at Eli Lilly and an important day for women around the world living with breast cancer as we have just announced the positive results showing that Verzenio extends life for women with breast cancer in the MONARCH 2 trial.

對於禮來公司來說，這既是一個激動人心的早晨，也是世界各地患有乳腺癌的女性的重要一天，因為我們剛剛宣布了積極的結果，表明 Verzenio 在 MONARCH 2 試驗中延長了患有乳腺癌的女性的生命。

More on that in a few minutes, but first, let me make a few comments on the overall performance in the quarter.

幾分鐘後會詳細介紹，但首先，讓我對本季度的整體表現發表一些評論。

We continue to execute on our strategic objectives, focusing on launch excellence, progressing our pipeline and improving productivity and our capabilities.

我們繼續執行我們的戰略目標，專注於推出卓越，推進我們的管道和提高生產力和我們的能力。

Second quarter revenue grew 1% and 3% in constant currency despite the loss of U.S. exclusivity for Cialis late last year and the impact of Lartruvo's impending product withdrawal.

儘管去年年底 Cialis 失去了美國的獨家經營權以及 Lartruvo 即將退出產品的影響，但第二季度的收入增長了 1% 和 3%。

Q2 marked our 15th consecutive quarter of worldwide revenue growth.

第二季度是我們連續第 15 個季度實現全球收入增長。

Our performance was driven by volume growth of 6%.

我們的業績是由 6% 的銷量增長推動的。

Excluding the Cialis loss of exclusivity and the impact of Lartruvo, volume grew nearly 15% led by our key growth products, which accounted for 43% of the company's revenue.

剔除 Cialis 的排他性損失和 Lartruvo 的影響，在我們的主要增長產品的帶動下，銷量增長了近 15%，占公司收入的 43%。

Q2 non-GAAP operating margin was 27.9%, representing a 250 basis point decline versus last year.

第二季度非美國通用會計準則營業利潤率為 27.9%，比去年下降 250 個基點。

This reflects a decrease in gross margin and increased investment in both our launches and our pipeline.

這反映了毛利率的下降以及對我們的發布和管道的投資增加。

Operating margin improved by 170 basis points versus Q1 of this year, reflecting progress toward our margin goals for 2019 and 2020.

與今年第一季度相比，營業利潤率提高了 170 個基點，反映了我們在 2019 年和 2020 年的利潤率目標方面取得的進展。

We achieved milestones on several pipeline assets since our last earning call, including the FDA approval of Emgality for treatment of episodic cluster headaches in adults; the FDA approval of CYRAMZA as a single agent for patients with high AFP in second-line hepatocellular carcinoma; and FDA approval of BAQSIMI, our nasal glucagon for the treatment of severe hypoglycemia in patients with diabetes.

自上次財報電話會議以來，我們在多項管道資產上實現了里程碑，包括 FDA 批准 Emgality 用於治療成人發作性叢集性頭痛； FDA 批准 CYRAMZA 作為二線肝細胞癌高 AFP 患者的單藥； FDA 批准了 BAQSIMI，我們的鼻用胰高血糖素用於治療糖尿病患者的嚴重低血糖症。

We're pleased to note that for all 3 of these approvals, the Lilly product represents a first-in-class opportunity within their respective indications.

我們很高興地註意到，對於所有這 3 項批准，禮來產品在各自的適應症中代表了一流的機會。

Additional milestones to highlight include the positive Phase III data for higher doses of Trulicity in patients with type 2 diabetes and the positive Phase III overall survival data for Verzenio from the MONARCH 2 study, which I mentioned earlier, an exciting milestone for Verzenio, differentiating those medicines from others in the CDK 4/6 class.

需要強調的其他里程碑包括 2 型糖尿病患者使用更高劑量 Trulicity 的積極 III 期數據和來自 MONARCH 2 研究的 Verzenio 的積極 III 期總體生存數據，我之前提到過，這對 Verzenio 來說是一個令人興奮的里程碑，區分那些CDK 4/6 類其他人的藥物。

Also, in partnership with Pfizer, we're prioritizing a potential U.S. submission of tanezumab in patients with moderate-to-severe osteoarthritis pain by Q1 2020.

此外，我們與輝瑞合作，優先考慮在 2020 年第一季度之前在美國提交用於治療中度至重度骨關節炎疼痛的患者的 tanezumab。

followed by submissions in EU and Japan.

其次是在歐盟和日本的提交。

At this time, we are now planning regulatory submissions for moderate-to-severe chronic low back pain.

目前，我們正在計劃針對中度至重度慢性腰痛提交監管申請。

We continue to leverage our strong operating cash flow to augment our pipeline through external innovation and return capital to shareholders.

我們繼續利用我們強大的經營現金流，通過外部創新擴大我們的管道，並向股東返還資本。

We announced a worldwide licensing agreement for a novel small molecule from Centrexion Therapeutics that is currently being studied as a potential non-opioid treatment for chronic pain conditions.

我們宣布了一項來自 Centrexion Therapeutics 的新型小分子的全球許可協議，該小分子目前正在研究作為一種潛在的非阿片類藥物治療慢性疼痛。

We completed the $3.5 billion accelerated share repurchase program announced in Q1, and we returned nearly $600 million to shareholders via the dividend.

我們完成了第一季度宣布的 35 億美元加速股票回購計劃，我們通過股息向股東返還了近 6 億美元。

Moving on to Slide 5, you'll see more detail on the key events since our last earnings call in April.

轉到幻燈片 5，您將看到自 4 月上次財報電話會議以來關鍵事件的更多詳細信息。

In our continuing efforts to make medicines more affordable for patients, we launched Lilly Insulin Lispro this quarter at a list price of 50% lower than the current Humalog list price.

在我們不斷努力使患者更能負擔得起藥物的過程中，我們在本季度推出了禮來胰島素 Lispro，其標價比當前的 Humalog 標價低 50%。

While an important solution for patients, access so far has been limited.

雖然對患者來說是一個重要的解決方案，但到目前為止訪問一直受到限制。

We will continue to work with payers to make this important solution accessible to patients.

我們將繼續與付款人合作，讓患者能夠使用這一重要的解決方案。

I would also like to highlight our leadership changes.

我還想強調我們的領導層變動。

First, a sincere note of gratitude to Mike Harrington for his first tremendous leadership and service to our company.

首先，衷心感謝邁克·哈靈頓（Mike Harrington）對我們公司的首次出色領導和服務。

Mike, you've done a great job defending the company and serving as a key adviser to our leadership team and our board.

邁克，你在保衛公司和擔任我們領導團隊和董事會的重要顧問方面做得很好。

Second, I would like to welcome Patrik Jonsson as he assumes leadership for our Bio-Medicines business unit.

其次，我要歡迎 Patrik Jonsson 擔任我們生物醫藥業務部門的領導。

Patrik is a patient-focused leader with a long track record of delivering results in some of our largest markets.

Patrik 是一位以患者為中心的領導者，在我們的一些最大市場中擁有長期的業績記錄。

Under Patrik's leadership, Lilly Japan has climbed from the 17th-ranked pharma company in Japan in 2014 to the #6 ranking at the end of this year.

在 Patrik 的領導下，禮來日本從 2014 年在日本排名第 17 位的製藥公司攀升至今年年底的第 6 位。

We delivered the highest growth rate in Japan during that period of time, which included the successful launches of our key growth products.

在此期間，我們實現了日本最高的增長率，其中包括成功推出我們的主要增長產品。

It's great to have Patrik join the senior leadership team.

很高興 Patrik 加入高級領導團隊。

Now I'll turn the call over to Josh to review our Q2 results and to provide an update on the financial guidance for the balance of 2019.

現在，我將把電話轉給喬什，以審查我們的第二季度業績，並提供有關 2019 年餘額財務指導的最新信息。

Thanks, Dave.

謝謝，戴夫。

Slide 6 summarizes our presentation of GAAP results to non-GAAP measures, and Slide 7 provides a summary of our GAAP results.

幻燈片 6 總結了我們對非 GAAP 指標的 GAAP 結果的介紹，幻燈片 7 總結了我們的 GAAP 結果。

Looking at the non-GAAP measures on Slide 8, you'll see revenue increased 1%.

查看幻燈片 8 上的非 GAAP 指標，您會看到收入增長了 1%。

Gross margin as a percent of revenue increased to 81.0%.

毛利率佔收入的百分比增加到 81.0%。

Excluding the impact of FX on international inventory sold, gross margin as a percent of revenue was 80.2%, keeping us on track to achieve our long-term goals for manufacturing efficiency and profitability.

排除外匯對國際銷售庫存的影響，毛利率佔收入的百分比為 80.2%，使我們能夠實現製造效率和盈利能力的長期目標。

On the same basis, our gross margin declined approximately 60 basis points compared to Q2 2018 driven by unfavorable impact of product mix and the negative impact of price on revenue, partially offset by manufacturing efficiencies.

同樣，由於產品組合的不利影響和價格對收入的負面影響，我們的毛利率與 2018 年第二季度相比下降了約 60 個基點，部分被製造效率所抵消。

Total operating expense increased 8% with marketing, selling and administrative expense increasing 7%, driven primarily by higher marketing investments to support the recent launch of Emgality in the U.S. as well as other key growth products.

總運營費用增長 8%，營銷、銷售和行政費用增長 7%，這主要是由於增加了營銷投資以支持最近在美國推出的 Emgality 以及其他關鍵增長產品。

R&D expense increased 10%, reflecting higher development expenses for late-stage assets, including tirzepatide, our RET inhibitor and mirikizumab.

研發費用增加了 10%，反映出後期資產的開發費用增加，包括我們的 RET 抑製劑和 mirikizumab。

Total operating income decreased 7% compared to Q2 2018 driven by the investments I just mentioned, which put our operating income as a percent of revenue at 27.9% for the quarter.

在我剛才提到的投資的推動下，與 2018 年第二季度相比，總營業收入下降了 7%，這使我們本季度的營業收入佔收入的百分比為 27.9%。

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

隨著我們最近的推出繼續推動收入和經營槓桿，我們預計收入增長和經營利潤率的提高。

And we remain on track to achieve our full year guidance of 28% as well as our 2020 target of 31%.

我們仍有望實現 28% 的全年指導以及 2020 年 31% 的目標。

Other income and expense was expense of $32 million this quarter compared to income of $21 million in Q2 2018.

本季度的其他收入和支出為 3200 萬美元，而 2018 年第二季度的收入為 2100 萬美元。

This was driven by higher net interest expense primarily related to the Loxo acquisition.

這是由於主要與 Loxo 收購相關的較高的淨利息支出所致。

Our tax rate was 10%, a decrease of 670 basis points compared with the same quarter last year, driven primarily by a net discrete tax benefit associated with the resolution of U.S. and foreign tax audits as well as the timing associated with the impact of the U.S. tax reform.

我們的稅率為 10%，與去年同期相比下降了 670 個基點，這主要是由於與解決美國和外國稅務審計相關的淨離散稅收優惠，以及與美國稅制改革。

At the bottom line, net income declined 3%, while earnings per share increased 1% due to a reduction in shares outstanding from share repurchases.

歸根結底，淨收入下降了 3%，而每股收益增長了 1%，原因是來自股票回購的流通股減少。

In Q2, we made good progress aligned with our strategic priorities, as evidenced by driving strong volume-based revenue growth despite significant headwinds from the loss of exclusivity of Cialis in the U.S. and the impact of Lartruvo; investing behind key growth brands such as Emgality, Verzenio, Taltz, Jardiance and Trulicity; and continued pipeline progress, including 3 regulatory approvals, 2 submissions and positive Phase III readouts for 2 key growth products.

在第二季度，我們在與我們的戰略重點相一致的情況下取得了良好的進展，儘管在美國失去 Cialis 的獨家經營權和 Lartruvo 的影響帶來了巨大的阻力，但仍推動了基於銷量的強勁收入增長就證明了這一點；投資於 Emgality、Verzenio、Taltz、Jardiance 和 Trulicity 等關鍵增長品牌；以及持續的管道進展，包括 3 項監管批准、2 項提交和 2 個關鍵增長產品的積極 III 期讀數。

Slide 9 outlines the same non-GAAP measures for June year-to-date, while Slide 10 provides a reconciliation between recorded and non-GAAP EPS.

幻燈片 9 概述了今年 6 月至今的相同非公認會計原則措施，而幻燈片 10 提供了記錄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 Slides 27 and 28.

您可以在幻燈片 27 和 28 上找到有關這些調整的更多詳細信息。

Moving to Slide 11, let's take a look at the effect of price, rate and volume on revenue growth.

轉到幻燈片 11，讓我們看看價格、費率和數量對收入增長的影響。

This quarter, worldwide revenue grew 3% on a performance basis, driven by a 6% increase in volume partially offset by price.

本季度，由於銷量增長 6% 被價格部分抵消，全球收入按業績增長 3%。

Foreign exchange reduced revenue growth by 2 percentage points.

外匯使收入增長減少了 2 個百分點。

For the 10th straight quarter, we delivered volume growth in each major geography.

連續第 10 個季度，我們在每個主要地區實現了銷量增長。

U.S revenue was flat compared to the second quarter of 2018.

與 2018 年第二季度相比，美國收入持平。

Volume growth of 5% was led by Trulicity, Taltz, Jardiance and Alimta.

Trulicity、Taltz、Jardiance 和 Alimta 的銷量增長了 5%。

Excluding Cialis and Lartruvo, volume grew nearly 17% in the U.S. with our diabetes products delivering over 24% volume growth.

不包括 Cialis 和 Lartruvo，美國的銷量增長了近 17%，我們的糖尿病產品銷量增長了 24% 以上。

Consistent with our 2019 financial guidance, U.S. price declined 4%, with nearly 3% driven by increased rebates in the Medicare Part D coverage gap resulting from the change this year that moved manufacturing funding from 50% to 70% of the doughnut hole.

與我們 2019 年的財務指導一致，美國價格下跌了 4%，其中近 3% 是由於今年將製造資金從甜甜圈洞的 50% 轉移到 70% 的變化導致醫療保險 D 部分覆蓋缺口的回扣增加。

Approximately 2% was due to unfavorable segment mix.

大約 2% 是由於不利的細分市場組合。

The remaining 1% price favorability is a mix of modest list price increases and favorable adjustments to estimates for rebates and discounts, partially offset by higher contracted rebates and patient affordability initiatives.

剩餘 1% 的價格優惠是適度的標價上漲和對回扣和折扣估計的有利調整的組合，部分被更高的合同回扣和患者負擔能力計劃所抵消。

Going forward, we expect the changes in coverage gap funding to continue to impact Q3 with less impact in Q4, and we still anticipate mid-single-digit declines in U.S. price for the full year.

展望未來，我們預計覆蓋缺口資金的變化將繼續影響第三季度，而第四季度的影響較小，我們仍預計全年美國價格將出現中個位數的下降。

Moving on to Europe.

繼續前往歐洲。

Revenue grew 6% excluding FX driven by volume, partially offset by the negative effect of price.

收入增長 6%，不包括受數量驅動的外匯，部分被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, revenue growth of 4% excluding FX was driven by volume, with Verzenio, Olumiant and Cymbalta as key contributors to the growth.

在日本，不包括外彙的收入增長 4% 是由銷量推動的，Verzenio、Olumiant 和 Cymbalta 是增長的主要貢獻者。

Revenue in the rest of the world increased 12% excluding FX led by 26% growth in China on the same basis.

世界其他地區的收入增長了 12%，其中不包括外匯，其中中國增長了 26%。

At the bottom of the slide is the same information for our June year-to-date results.

幻燈片底部是我們 6 月份年初至今結果的相同信息。

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

如幻燈片 12 所示，我們的主要增長產品再次成為我們全球銷量增長的引擎。

These products drove 15.4 percentage points of volume growth this quarter, reinforcing our confidence in achieving our 2020 revenue goals.

這些產品在本季度推動了 15.4 個百分點的銷量增長，增強了我們實現 2020 年收入目標的信心。

Brands that have experienced loss of exclusivity provided a drag of 650 basis points driven primarily by Cialis.

經歷了排他性喪失的品牌拖累了 650 個基點，主要由 Cialis 推動。

As expected, we've seen a rapid erosion of Cialis sales following the entry of generics in the U.S. market at the end of September last year.

正如預期的那樣，在去年 9 月底仿製藥進入美國市場後，我們看到 Cialis 的銷售額迅速下降。

We expect this drag to continue in Q3 and begin to normalize in Q4.

我們預計這種拖累將在第三季度繼續，並在第四季度開始正常化。

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 over $2.4 billion in revenue this quarter, growing to 43% of revenue.

總的來說，這些品牌本季度創造了超過 24 億美元的收入，增長到收入的 43%。

In addition to the sustained strong performance of Trulicity, Taltz and Jardiance, I'd like to highlight the performance of CYRAMZA, which grew 19% in the U.S. as our share of market doubled in second-line lung.

除了 Trulicity、Taltz 和 Jardiance 的持續強勁表現外，我想強調 CYRAMZA 的表現，隨著我們在二線肺的市場份額翻倍，CYRAMZA 在美國增長了 19%。

We look forward to continued growth as we launched the high-AFP HCC indication in the second quarter and expect to submit first-line metastatic EGFR-mutated non-small cell lung cancer in the U.S. later this year.

隨著我們在第二季度推出高 AFP HCC 適應症，並預計今年晚些時候在美國提交一線轉移性 EGFR 突變非小細胞肺癌，我們期待繼續增長。

We're excited to see Emgality continue to gain share, exiting Q2 at 41% share of market for new-to-brand prescriptions in the U.S., which is an increase of approximately 9 share points from where we exited Q1.

我們很高興看到 Emgality 繼續獲得份額，在第二季度以 41% 的美國新品牌處方市場份額退出，這比我們退出第一季度的市場份額增加了大約 9 個點。

As our best-in-class access continues to grow, we exited the quarter with 8 scripts at approximately 3/4 of total U.S. scripts.

隨著我們一流的訪問權限持續增長，我們在本季度以 8 個腳本退出，約占美國腳本總數的 3/4。

We look forward to Emgality continuing its strong uptake in the U.S., contributing meaningfully to sales in the second half of 2019.

我們期待 Emgality 繼續在美國的強勁增長，為 2019 年下半年的銷售做出有意義的貢獻。

Slide 14 shows the year-over-year change in select lines of our income statement.

幻燈片 14 顯示了我們損益表中特定行的同比變化。

Focusing on our non-GAAP results, foreign exchange rate had little impact on gross margin and modest positive impact on operating expenses, operating income and EPS.

著眼於我們的非公認會計原則結果，匯率對毛利率的影響很小，對營業費用、營業收入和每股收益有適度的積極影響。

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 updated our non-GAAP guidance to reflect the increase in our bottom line results for the year.

您會看到我們已經更新了我們的非公認會計原則指南，以反映我們今年底線業績的增長。

Specifically, we are raising and narrowing the range for SG&A expense to $5.9 billion to $6.1 billion, reflecting continued investments in recent launches.

具體來說，我們正在將 SG&A 費用的範圍提高並縮小至 59 億美元至 61 億美元，這反映了近期推出的持續投資。

We are lowering the range for other income and deductions to 0 to an expense of $150 million, reflecting first half gains in our equity portfolio.

我們正在將其他收入和扣除額的範圍降低到 0 到 1.5 億美元的費用，這反映了我們股票投資組合的上半年收益。

We are decreasing our tax rate from a range of 14% to 15% to 13% to 14% to reflect the net discrete tax benefit associated with the resolution of tax audits in Q2.

我們正在將稅率從 14% 降低到 15% 到 13% 到 14%，以反映與第二季度解決稅務審計相關的淨離散稅收優惠。

And we are raising our non-GAAP earnings per share range to $5.67 per share to $5.77 per share, which reflects the Q2 discrete tax benefit as our performance expectations remain unchanged.

我們將非公認會計準則每股收益範圍提高至每股 5.67 美元至每股 5.77 美元，這反映了第二季度的離散稅收優惠，因為我們的業績預期保持不變。

On a reported basis, the tax rate is expected to be in the range of 14% to 15%, and earnings per share for 2019 is now expected to be in the range of $8.58 per share to $8.68 per share.

據報導，稅率預計在 14% 至 15% 之間，2019 年的每股收益現在預計在每股 8.58 美元至 8.68 美元之間。

Slide 16 shows the progress we have made towards our 2020 revenue and operating margin goals.

幻燈片 16 顯示了我們在實現 2020 年收入和營業利潤率目標方面取得的進展。

On the left of the slide, the midpoint of our 2019 guidance represents 5% revenue growth over 2018 in constant currency despite headwinds from the loss of exclusivity for Cialis and the impact of Lartruvo.

在幻燈片的左側，我們 2019 年指導的中點表示按固定匯率計算的收入比 2018 年增長 5%，儘管 Cialis 失去排他性和 Lartruvo 的影響帶來了不利因素。

With that performance in 2019, we would need to grow sales at 6% in 2020 to achieve the 2015/2020 minimum compound annual growth rate of 7% that we've outlined.

憑藉 2019 年的表現，我們需要在 2020 年將銷售額增長 6%，以實現我們概述的 2015/2020 年最低複合年增長率 7%。

As the headwind from Cialis LOE and Lartruvo abates in 2020 and our new products continue to scale, we're confident that we'll achieve that minimum revenue goal.

隨著 Cialis LOE 和 Lartruvo 的不利因素在 2020 年減弱，我們的新產品繼續擴大規模，我們有信心實現這一最低收入目標。

On the right, you can see that we've delivered significant margin expansion since 2015, increasing from just under 20% to over 29% last year.

在右側，您可以看到我們自 2015 年以來實現了顯著的利潤率增長，從去年的不到 20% 增加到超過 29%。

Again, as the impact of the Cialis LOE and Lartruvo diminishes this year and as our new products continue to scale, we're confident we'll achieve our 2020 goal of 31% operating margin.

同樣，隨著今年 Cialis LOE 和 Lartruvo 的影響減弱以及我們的新產品繼續擴大規模，我們有信心實現 2020 年 31% 的營業利潤率目標。

On Slide 17, we provide an update on capital allocation.

在幻燈片 17 上，我們提供了資本配置的最新信息。

Aligned with our strategic priorities, we spent over $10 billion in the first half of the year to drive future growth between our business development activities, capital expenditures and internal investment in R&D.

根據我們的戰略重點，我們在今年上半年花費了超過 100 億美元來推動我們的業務發展活動、資本支出和內部研發投資之間的未來增長。

In addition, we returned nearly $5 billion to shareholders.

此外，我們還向股東返還了近 50 億美元。

As we look ahead in the second half of the year, we'll continue to fund the growth of our new key products and recent launches, invest in our pipeline, seek external innovation to augment our future growth prospects and return capital to shareholders.

展望下半年，我們將繼續為我們的新關鍵產品和近期發布的增長提供資金，投資我們的管道，尋求外部創新以擴大我們未來的增長前景並向股東返還資本。

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

現在我將把電話轉給 Dan 來強調我們在研發方面的進展。

Thanks, Josh.

謝謝，喬希。

It's been an exciting quarter for R&D results, really capped off with the big news this morning that Verzenio's MONARCH 2 trial demonstrated positive efficacy at the interim analysis, improving overall survival for women with HR-positive HER2-negative breast cancer.

對於研發結果來說，這是一個令人興奮的季度，今天早上的重大新聞是 Verzenio 的 MONARCH 2試驗在中期分析中顯示出積極的療效，提高了 HR 陽性 HER2 陰性乳腺癌女性的總體生存率。

A bit more color on Verzenio and this important result in a minute, but first I'll summarize some of the other R&D highlights for the quarter.

稍後再對 Verzenio 和這個重要結果進行更多的介紹，但首先我將總結本季度的其他一些研發亮點。

Slide 18 shows select pipeline opportunities as of July 25.

幻燈片 18 顯示了截至 7 月 25 日的選定管道機會。

Movement since our last earnings call includes the regulatory approvals that Dave mentioned earlier; the regulatory submission of empagliflozin in collaboration with Boehringer Ingelheim for type 1 diabetes; and the regulatory submission of CYRAMZA for first-line EGFR-positive non-small cell lung cancer; the initiation of Phase III testing for baricitinib in alopecia areata; the initiation of Phase I for 5 assets, including our oral GLP-1 receptor agonist and the attrition of 2 Phase I molecules.

自我們上次財報電話會議以來的變動包括 Dave 之前提到的監管批准；與勃林格殷格翰合作提交的 empagliflozin 用於 1 型糖尿病的監管提交；以及 CYRAMZA 對一線 EGFR 陽性非小細胞肺癌的監管提交；開始在斑禿中進行巴瑞替尼 III 期試驗；啟動 5 項資產的 I 期，包括我們的口服 GLP-1 受體激動劑和 2 個 I 期分子的消耗。

Moving to Slide 19.

轉到幻燈片 19。

Since the last earnings call, we've made progress on a number of key events that we're monitoring for 2019, including the approvals, submissions and top line disclosures that Dave and I have already mentioned.

自上次財報電話會議以來，我們在 2019 年監控的一些關鍵事件上取得了進展，包括戴夫和我已經提到的批准、提交和頂線披露。

New this quarter, we've added the top line readout for pegilodecakin SEQUOIA trial to the Phase III trial in combination with FOLFOX in second-line pancreatic cancer, and we expect this event-driven trial to read out later this year.

本季度新增功能，我們將 pegilodecakin SEQUOIA 試驗的一線讀數添加到與 FOLFOX 聯合用於二線胰腺癌的 III 期試驗中，我們預計這項事件驅動的試驗將在今年晚些時候公佈。

You'll recall that ARMO had moved this program into Phase III based on limited data for Phase I. This was driven by the high unmet medical need in second-line pancreatic cancer.

您會記得，ARMO 已根據 I 期的有限數據將該計劃移至 III 期。這是由二線胰腺癌的高未滿足醫療需求推動的。

As we've shared in previous updates, we still see lung and renal cancer as the key indications for this molecule.

正如我們在之前的更新中所分享的，我們仍然將肺癌和腎癌視為該分子的主要適應症。

Later this year, we'll initiate a study in renal cell cancer as well as a biomarker-driven study in lung cancer.

今年晚些時候，我們將啟動一項腎細胞癌研究以及一項由生物標誌物驅動的肺癌研究。

In diabetes, we had a number of medical presentations at this year's American Diabetes Association meeting, including Ultra Rapid Lispro for type 1 and type 2 diabetes, the Trulicity REWIND CV outcomes study as well as several tirzepatide data sets.

在糖尿病方面，我們在今年的美國糖尿病協會會議上進行了許多醫學報告，包括用於 1 型和 2 型糖尿病的 Ultra Rapid Lispro、Trulicity REWIND CV 結果研究以及幾個 tirzepatide 數據集。

I'll share a few key takeaways from the ADA meeting.

我將分享 ADA 會議的一些重要內容。

Moving to Slide 20, I'll highlight the tirzepatide dose escalation study.

轉到幻燈片 20，我將重點介紹 tirzepatide 劑量遞增研究。

The study demonstrated consistent efficacy with improved tolerability relative to the Phase IIb study that we shared at EASD in 2018.

與我們在 2018 年 EASD 分享的 IIb 期研究相比，該研究證明了一致的療效和更高的耐受性。

This is evidenced by a significant reduction in the treatment discontinuation rates shown here.

此處顯示的治療中止率顯著降低證明了這一點。

The GI side effects that did occur were mostly mild to moderate and were less severe than in the first Phase IIb study.

確實發生的胃腸道副作用大多是輕度到中度的，並且沒有第一次 IIb 期研究那麼嚴重。

These results are encouraging particularly because the dose escalation in the Phase III study follows a slower stepwise design and was tested in the Phase II dose escalation study.

這些結果特別令人鼓舞，因為 III 期研究中的劑量遞增遵循較慢的逐步設計，並在 II 期劑量遞增研究中進行了測試。

We believe tirzepatide has the opportunity to reset treatment expectations for patients for HbA1c and weight loss relative to current therapies.

我們相信，相對於當前療法，替西帕肽有機會重新設定患者對 HbA1c 和體重減輕的治療預期。

Five trials in the SURPASS program are already underway, and we look forward to data readouts beginning in 2021.

SURPASS 計劃的五項試驗已經在進行中，我們期待從 2021 年開始的數據讀出。

Turning to Slide 21.

轉到幻燈片 21。

You'll see summary data regarding the REWIND cardiovascular outcomes study for Trulicity.

您將看到有關 Trulicity 的 REWIND 心血管結局研究的匯總數據。

As a reminder, the patient population included in REWIND was different from other CV studies for GLP-1s as observed by the notably lower rate of MACE events in the placebo arm depicted on the left.

提醒一下，REWIND 中包含的患者群體與其他 GLP-1 CV 研究不同，如左側所示的安慰劑組 MACE 事件發生率顯著降低所觀察到的。

Studying a lower-CV risk patient population established a high bar to demonstrate efficacy and generated data in a population that's more representative of diabetes patients seen in physicians' offices.

研究心血管風險較低的患者群體建立了一個高標準來證明療效，並在更能代表醫生辦公室所見糖尿病患者的群體中生成數據。

Despite the high bar for efficacy, Trulicity demonstrated clinically meaningful 12% reduction in MACE while demonstrating safety consistent with prior studies.

儘管療效標準很高，但 Trulicity 證明了具有臨床意義的 MACE 減少了 12%，同時證明了與先前研究一致的安全性。

Equally impressive is the consistency of MACE results, which showed a benefit across a variety of measures, most notably the prespecified subgroups of patients with and without prior CV disease.

同樣令人印象深刻的是 MACE 結果的一致性，它在各種測量中顯示出益處，最顯著的是預先指定的有和沒有先前 CV 疾病的患者亞組。

We expect the label to reflect the broad population we studied, and we look forward to hearing from regulators on our submissions.

我們希望該標籤能夠反映我們研究的廣泛人群，並且我們期待收到監管機構對我們提交的意見的意見。

Moving to Slide 22.

轉到幻燈片 22。

Last quarter, we highlighted the 4 big late-phase bets we've made over the last 12 months.

上個季度，我們重點介紹了我們在過去 12 個月中所做的 4 大後期押注。

This quarter, I'd like to highlight select Phase II opportunities.

本季度，我想強調選擇第二階段的機會。

But first, let me start with some comments on Verzenio.

但首先，讓我先談談對 Verzenio 的一些評論。

Obviously, we've made exciting progress with this medicine, now generating additional data in Phase II and Phase III, which highlight Verzenio's important differentiation versus other CDK 4/6 inhibitors.

顯然，我們在這種藥物方面取得了令人興奮的進展，現在在 II 期和 III 期產生了額外的數據，這突出了 Verzenio 與其他 CDK 4/6 抑製劑的重要區別。

When we previewed upcoming data readouts at our December 2018 investor meeting, we highlighted 3 important readouts that we expected over 3 consecutive years.

當我們在 2018 年 12 月的投資者會議上預覽即將發布的數據時，我們強調了我們連續 3 年預期的 3 個重要數據。

We said we expected Phase II data in HER2-positive patients in 2019, Phase III data for overall survival for MONARCH 2 in 2020 and Phase III adjuvant data in 2021.

我們說我們預計 2019 年 HER2 陽性患者的 II 期數據，2020 年 MONARCH 2 的總體生存期 III 期數據和 2021 年的 III 期輔助數據。

We're pleased to show today that the first 2 of these readouts have occurred and both are positive.

我們今天很高興地表明，前兩個讀數已經發生，而且都是正面的。

As per our press release this morning, the MONARCH 2 readout occurred earlier than expected and showed Verzenio extended life for women with metastatic HR-positive HER2-negative breast cancer.

根據我們今天早上發布的新聞稿，MONARCH 2 的讀數比預期的要早，並顯示 Verzenio 延長了患有轉移性 HR 陽性 HER2 陰性乳腺癌的女性的生命。

This interim analysis was the first robust analysis of overall survival and required a stringent p-value.

該中期分析是對總生存期的首次穩健分析，需要嚴格的 p 值。

While we had originally expected this trial to go to its final analysis in 2020, the results were strong enough to meet the endpoint at the interim analysis, making Verzenio the first and only CDK 4/6 inhibitor in combination with fulvestrant to achieve statistically significant improvement in overall survival.

雖然我們最初預計該試驗將在 2020 年進行最終分析，但結果足以滿足中期分析的終點，使 Verzenio 成為第一個也是唯一一個 CDK 4/6 抑製劑與氟維司群聯合使用以實現統計學顯著改善在總生存期。

We look forward to presenting these results later this year and working with regulators to submit this important new data.

我們期待在今年晚些時候公佈這些結果，並與監管機構合作提交這些重要的新數據。

In addition, we're announcing today that our Phase II trial in HER-2 positive breast cancer was positive, making Verzenio the first CDK 4/6 inhibitor to show positive efficacy in a randomized controlled trial in this HER-2 positive population.

此外，我們今天宣布，我們在 HER-2 陽性乳腺癌中的 II 期試驗是陽性的，這使 Verzenio 成為第一個在 HER-2 陽性人群的隨機對照試驗中顯示出陽性療效的 CDK 4/6 抑製劑。

We'll work with regulators to determine the appropriate next steps.

我們將與監管機構合作，確定適當的後續步驟。

Also, we're pleased to hear today that MONARCH plus, our Phase III study in China, was stopped early due to efficacy.

此外，我們很高興今天聽到我們在中國的 III 期研究 MONARCH plus 由於療效而提前停止。

This data will support our upcoming submission for approval in China.

這些數據將支持我們即將在中國提交審批。

Finally, I should say we're still very much looking forward to receiving data in the adjuvant population, and our Phase III trial in this population is still expected to read out in 2021.

最後，我應該說，我們仍然非常期待收到輔助人群的數據，我們在該人群中的 III 期試驗仍有望在 2021 年公佈。

Now let me turn back to the topic of ongoing Phase II trials.

現在讓我回到正在進行的 II 期試驗的話題。

Touching briefly on pegilodecakin, in addition to the Phase III pancreatic cancer results we now expect in 2019, the Phase II lung cancer trials, Cypress 1 and Cypress 2, are on track to complete later this year, and we expect data disclosures to come in 2020.

簡要介紹一下 pegilodecakin，除了我們現在預計在 2019 年獲得 III 期胰腺癌結果外，II 期肺癌試驗 Cypress 1 和 Cypress 2 有望在今年晚些時候完成，我們預計數據披露將會到來2020 年。

Moving to neuroscience.

轉向神經科學。

Zagotenemab is our anti-tau antibody currently in a placebo-controlled study of nearly 300 patients.

Zagotenemab 是我們的抗 tau 抗體，目前正在對近 300 名患者進行安慰劑對照研究。

This study uses a tau imaging agent to identify early symptomatic Alzheimer's patients whose disease has not progressed beyond the potentially treatable state.

這項研究使用 tau 顯像劑來識別早期有症狀的阿爾茨海默病患者，這些患者的疾病尚未進展到潛在的可治療狀態之外。

While Alzheimer's is a higher-risk area, we believe our molecule uniquely targets aggregated forms of tau, a key pathologic hallmark of the disease.

雖然阿爾茨海默病是一個高風險領域，但我們相信我們的分子獨特地針對聚集形式的 tau，這是該疾病的一個關鍵病理標誌。

And our trial design incorporates unique elements that will help us best learn a treatment with a tau antibody is a beneficial strategy for Alzheimer's disease.

我們的試驗設計結合了獨特的元素，這些元素將幫助我們最好地了解用 tau 抗體治療阿爾茨海默病的有益策略。

We look forward to seeing the data in 2021.

我們期待在 2021 年看到數據。

In addition, D1PAM is our positive allosteric modulator that targets the dopamine D1 receptor.

此外，D1PAM 是我們針對多巴胺 D1 受體的正變構調節劑。

We previously shared some encouraging Phase I data, and we're now studying this molecule in Phase II in the symptomatic treatment of Lewy body dementia, which includes patients with both dementia with Lewy bodies and Parkinson's disease dementia, focusing on improving attention and cognition.

我們之前分享了一些令人鼓舞的 I 期數據，現在我們正在 II 期研究這種分子在路易體癡呆的對症治療中，其中包括患有路易體癡呆和帕金森病癡呆的患者，重點是提高注意力和認知能力。

Based on enrollment, we expect data in early 2020.

根據註冊情況，我們預計 2020 年初的數據。

If we see a signal in the Phase II data, we're prepared to move quickly into symptomatic treatment of Lewy body dementia as well as Alzheimer's disease.

如果我們在 II 期數據中看到一個信號，我們準備迅速進入路易體癡呆和阿爾茨海默病的對症治療。

In immunology, we recently moved our anti-IL-33 antibody into Phase II development in patients with moderate-to-severe atopic dermatitis, an area of high unmet medical need.

在免疫學方面，我們最近將我們的抗 IL-33 抗體轉移到中度至重度特應性皮炎患者的 II 期開發中，這是一個高度未滿足的醫療需求領域。

We're excited about the potential of this target and this molecule.

我們對這個目標和這個分子的潛力感到興奮。

This asset builds on our emerging immunology portfolio, and we anticipate seeing data in the first half of next year.

這項資產建立在我們新興的免疫學產品組合之上，我們預計將在明年上半年看到數據。

Finally, I'd like to highlight 2 diabetes programs.

最後，我想強調兩個糖尿病項目。

First is our Basal Insulin-FC, which is a next-generation basal insulin.

首先是我們的基礎胰島素-FC，它是下一代基礎胰島素。

Basal Insulin-FC uses the same time extension technology that we used to create Trulicity, enabling convenient once-weekly dosing.

Basal Insulin-FC 使用與我們用於創建 Trulicity 相同的時間延長技術，實現每週一次的便捷給藥。

This asset has the potential to be the first weekly basal insulin and could be an important new treatment option for people with diabetes.

這項資產有可能成為第一個每週基礎胰島素，並可能成為糖尿病患者的重要新治療選擇。

We're anticipating reporting top line data next year.

我們預計明年將報告頂級數據。

Second, we have ongoing efforts focused on improving the delivery of insulin and improving patient outcomes.

其次，我們一直致力於改善胰島素的輸送和改善患者的治療效果。

We know that more than half of people on insulin today are not achieving their A1c treatment goals.

我們知道，今天超過一半的胰島素治療者沒有達到他們的 A1c 治療目標。

The ongoing Phase II efforts of our automated insulin delivery system are the first step in an iterative process towards a closed-loop system that we believe has the potential to significantly increase the number of patients achieving their A1c goals.

我們的自動化胰島素輸送系統正在進行的 II 期工作是邁向閉環系統的迭代過程的第一步，我們認為該系統有可能顯著增加實現 A1c 目標的患者數量。

Pending positive Phase II data, we have moved into Phase III in 2020 with a potential launch in 2021.

在等待積極的 II 期數據之前，我們已在 2020 年進入 III 期，並可能在 2021 年推出。

We look forward to tracking the progress of these assets over the coming years, and we'll share additional pipeline updates on our next earnings call.

我們期待在未來幾年跟踪這些資產的進展，我們將在下一次財報電話會議上分享更多的管道更新。

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。

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

在進行問答之前，讓我簡要總結一下我們在第二季度取得的進展。

We delivered volume growth of 6% despite the continued erosion of Cialis due to generic competition and the withdrawal of Lartruvo.

儘管由於仿製藥競爭和 Lartruvo 的退出，Cialis 繼續受到侵蝕，但我們的銷量增長了 6%。

Key growth products delivered impressive volume growth of 15%, which now represents 43% of our revenue.

關鍵增長產品實現了 15% 的驚人銷量增長，目前占我們收入的 43%。

We made strategic investments in commercial and late-stage pipeline products to reach more patients today and improve the standard of care in the future.

我們對商業和後期管道產品進行了戰略投資，以在今天接觸更多患者並提高未來的護理標準。

Meanwhile, we continued to progress towards our margin goals as operating margin improved 170 basis points versus Q1 2019.

與此同時，我們繼續朝著我們的利潤率目標前進，因為營業利潤率與 2019 年第一季度相比提高了 170 個基點。

We made progress with the pipeline this quarter, including 3 regulatory approvals along with the exciting MONARCH 2 overall survival readout for Verzenio.

本季度我們在管道方面取得了進展，包括 3 項監管批准以及 Verzenio 令人興奮的 MONARCH 2 總體生存率讀數。

In addition, we moved one asset into Phase III development while also advancing multiple assets into the clinic.

此外，我們將一項資產轉移到 III 期開發，同時還將多項資產推進臨床。

Looking ahead, we're excited about the data disclosure for our RET inhibitor at a major medical meeting and subsequent submission later this year.

展望未來，我們對我們的 RET 抑製劑在今年晚些時候的一次重大醫學會議和隨後提交的數據披露感到興奮。

We also returned over $600 million to shareholders via the dividend and completed our $3.5 billion accelerated share repurchase program.

我們還通過股息向股東返還了超過 6 億美元，並完成了 35 億美元的加速股票回購計劃。

Finally, last week, the Senate Finance Committee released details of its plan to address drug pricing and improve patient out-of-pocket cost for patients.

最後，上週，參議院財政委員會公佈了其解決藥品定價和改善患者自付費用的計劃細節。

This is, of course, just the latest in a continuing discussion in Congress and the administration, and it won't be the last word we'll hear from the Senate on this subject.

當然，這只是國會和政府持續討論的最新進展，這不會是我們從參議院聽到的關於這個問題的最後一句話。

I know there may be a lot of questions about this particular package, so let me make a few points here in the hopes of allowing our Q&A to focus on the solid Q2 results we delivered and the strong prospects for Lilly's future.

我知道關於這個特定的套餐可能有很多問題，所以讓我在這裡提出幾點，希望讓我們的問答能夠專注於我們交付的可靠的第二季度業績和禮來公司未來的強勁前景。

First, I want to assure investors that the industry has and will continue to focus on shaping this debate guided by our core principles of encouraging and protecting innovation, fairness and transparency in the pharma industry and all of health care and lowering costs at the pharmacy counter for patients who use our medicines.

首先，我想向投資者保證，該行業已經並將繼續關注以我們鼓勵和保護製藥行業創新、公平和透明以及所有醫療保健以及降低藥房櫃檯成本的核心原則為指導的這場辯論對於使用我們藥物的患者。

While the Senate Finance Committee package advances some of these ideas, it falls short on many others.

雖然參議院財政委員會的一攬子計劃推進了其中一些想法，但它在許多其他想法上都不盡如人意。

We'll be working with all stakeholders over the coming weeks and months to try to better align legislative proposals to our core principles.

在接下來的幾周和幾個月內，我們將與所有利益相關者合作，努力使立法提案更好地與我們的核心原則保持一致。

I know many of you have and will continue to work to size the impact of these proposals on the industry and on patient care.

我知道你們中的許多人已經並將繼續努力評估這些提案對行業和患者護理的影響。

So let me make a few comments here to help while reserving a more detailed numeric answer for a later time when there's more clarity and more certainty.

因此，讓我在這裡發表一些評論以提供幫助，同時保留更詳細的數字答案以供以後更清晰、更確定時使用。

The 3 parts of this package I'll highlight are the Part D redesign, resetting the 100% state cap in Medicaid and capping list price increases in Part B and D. Pharma has already put out a public statement on the policy concerns from a patient and innovation perspective, so I'll just focus on the practical implications here and assess the likelihood and the impact to Lilly.

我要強調的這個包的 3 個部分是 D 部分的重新設計，重置 Medicaid 的 100% 州上限以及 B 部分和 D 部分的定價上限。製藥公司已經就患者的政策問題發表了公開聲明和創新的觀點，所以我將只關注這裡的實際影響，並評估可能性和對禮來的影響。

[Lilly's view] is as follows.

【禮來的觀點】如下。

A Medicare Part D redesign, which includes an out-of-pocket maximum for beneficiaries, seems the most important and the most needed to be legislated in some form and is a proposal which will deliver savings to patients who use higher-cost medicines with the addition of this out-of-pocket cap.

醫療保險 D 部分的重新設計，其中包括受益人自付費用的最高限額，似乎是最重要的，也是最需要以某種形式立法的提案，該提案將為使用成本較高的藥物的患者節省開支。添加這個自費帽。

Based on our current portfolio, this would have a neutral to positive impact on our diabetes portfolio, which currently is our primary exposure in the Part D benefit, but it would have a negative impact on our immunology and oncology business.

根據我們目前的投資組合，這將對我們的糖尿病投資組合產生中性至積極的影響，這是我們目前在 D 部分收益中的主要風險敞口，但將對我們的免疫學和腫瘤學業務產生負面影響。

Removing the 100% rebate cap in Medicaid is the next most likely proposal in our view as it was -- it has also shown up in a draft House legislation as well.

在我們看來，取消 Medicaid 的 100% 回扣上限是下一個最有可能的提議——它也出現在眾議院立法草案中。

The current finance version phases in the new cap at 125% in late 2022, raising money for the government but delivering no benefit to patients.

當前的財務版本將在 2022 年底將新上限調整為 125%，為政府籌集資金，但對患者沒有任何好處。

In the near term, this would represent a larger headwind for us than the general industry primarily due to our insulin business.

在短期內，這對我們來說將是比一般行業更大的逆風，這主要是由於我們的胰島素業務。

Medicaid represents a little more than 10% of the U.S. Humalog and Humulin volume, so a 25% increased rebate would represent a moderate negative impact on our insulin revenue.

醫療補助占美國 Humalog 和 Humulin 銷量的 10% 多一點，因此增加 25% 的回扣將對我們的胰島素收入產生適度的負面影響。

Finally, capping list prices -- list price increases at the rate of CPI inflation in Medicare Part B and D will perhaps be the less likely to be enacted proposal that we've seen.

最後，限制定價——在醫療保險 B 部分和 D 部分中，定價以 CPI 通脹率上漲可能是我們所看到的不太可能實施的提案。

Medicare Part D has a market-based structure, which has worked quite well, coming in under budget while expanding access to innovation for millions of seniors.

醫療保險 D 部分具有基於市場的結構，運作良好，預算不足，同時擴大了數百萬老年人獲得創新的機會。

We're concerned about the price controls this represents.

我們擔心這代表的價格控制。

And mechanisms already exist to limit price increases in these segments through contracting in Part D and the AST reporting system in Part B. While Lilly has already significantly moderated list price increases for our medicines, this policy if enacted will continue to encourage this kind of moderation.

並且已經存在通過 D 部分中的合同和 B 部分中的 AST 報告系統來限制這些細分市場價格上漲的機制。雖然禮來已經顯著緩和了我們藥品的標價上漲，但如果頒布這項政策，將繼續鼓勵這種緩和.

Patient impact will be quite modest from this proposal, although accumulate through time as do the government savings.

該提案對患者的影響將非常有限，儘管隨著時間的推移會像政府的儲蓄一樣積累。

Unfortunately, none of these proposals address the fundamental structure issue of the gross-to-net spreads.

不幸的是，這些提議都沒有解決總淨價差的基本結構問題。

And this will remain a centerpiece of our advocacy over the coming months, to remake the incentives for all actors and deliver substantial out-of-pocket savings to patients who use innovative medicines.

在接下來的幾個月裡，這仍將是我們倡導的核心內容，為所有參與者重新制定激勵措施，並為使用創新藥物的患者提供大量的自付費用節省。

I would note that as presented -- presently constructed, these proposals would begin to take effect in 2021 and 2022 and currently would have no impact on our 2020 guidance.

我要指出的是，正如目前所提出的那樣，這些提案將在 2021 年和 2022 年開始生效，目前不會對我們的 2020 年指導產生影響。

Longer term, in any case, we will continue to focus on volume-driven growth through innovation.

無論如何，從長遠來看，我們將繼續專注於通過創新實現銷量驅動的增長。

Across our company, Lilly employees remain energized and motivated to progress the pipeline to bring innovative medicines to millions more -- million more patients who need solutions for different diseases.

在整個公司，禮來員工仍然充滿活力和積極性，以推進管道的發展，為數以百萬計的更多需要不同疾病解決方案的患者帶來創新藥物。

We are excited to execute our strategic priorities to deliver not only our 2019 and 2020 goals but also to realize the long-term growth opportunity in front of us.

我們很高興能夠執行我們的戰略重點，不僅實現我們的 2019 年和 2020 年目標，而且實現我們面前的長期增長機會。

This concludes our prepared remarks, and I will turn the call over to Kevin to moderate the Q&A session.

我們準備好的發言到此結束，我將把電話轉給 Kevin 主持問答環節。

Thanks, Dave.

謝謝，戴夫。

(Operator Instructions) And then we are ready for the first caller.

（操作員說明）然後我們準備迎接第一個來電者。

(Operator Instructions) And our first question will come from the line of Umer Raffat with Evercore.

（操作員說明）我們的第一個問題將來自於 Evercore 的 Umer Raffat。

First, I read the blog post with a lot of interest on Medicaid max rebate caps.

首先，我對 Medicaid 最高回扣上限非常感興趣地閱讀了這篇博文。

And my question is, what's the dollar impact if that cap is raised to 125%?

我的問題是，如果上限提高到 125%，對美元的影響是什麼？

And what's that dollar impact if there is no cap at all?

如果根本沒有上限，對美元的影響是什麼？

I think this is one of those questions every investor is just very curious about given the exposure here.

我認為這是每個投資者都非常好奇的問題之一，因為這裡的風險敞口。

That's first.

這是第一個。

Secondly, on R&D, I was curious, on Cypress 1 trial for ARMO, which they do this fall, I understand it's an open-label trial.

其次，在研發方面，我很好奇，他們今年秋天為 ARMO 進行的 Cypress 1 試驗，我知道這是一個開放標籤試驗。

How would you set the investor expectations going into that readout knowing that IO-IO of late has been very disappointing?

知道最近的 IO-IO 非常令人失望，您將如何設定投資者的預期？

Thanks, Umer.

謝謝，烏默爾。

We'll have Dave take the first question, and then, Anne, you're second.

我們讓戴夫回答第一個問題，然後，安妮，你是第二個。

Okay.

好的。

Appreciate the question, although I was hoping to head most of these off in my prepared remarks, Umer.

欣賞這個問題，儘管我希望在我準備好的評論中結束其中的大部分內容，Umer。

As I said, the -- any version of Medicaid AMP cap lift, we think, is a regressive policy.

正如我所說，我們認為任何版本的 Medicaid AMP 上限提升都是一種倒退政策。

It punishes companies by forcing us to underwrite state Medicaid, actually giving a rebate in excess of our list price.

它通過迫使我們承保州醫療補助來懲罰公司，實際上給予超過我們標價的回扣。

But policy issues aside, I think you're asking what the exposure of the company is.

但撇開政策問題不談，我想你是在問公司的曝光率是多少。

As I said, this almost exclusively impacts our insulin portfolio across the Lilly medicines.

正如我所說，這幾乎完全影響了我們在禮來藥物中的胰島素產品組合。

And we are in the low teens in terms of total volume for Medicaid as a percent of that -- those businesses.

就醫療補助總額的百分比而言，我們處於青少年時期 - 這些業務。

So that would be the theoretical cap on the impact to those businesses.

因此，這將是對這些業務影響的理論上限。

25% of that is a smaller number related to insulin and insulin related to the total of the company.

其中 25% 是與胰島素相關的較小數字，而與公司總數相關的胰島素。

So it's a concerning policy because of the nature of it.

因此，由於其性質，這是一項令人擔憂的政策。

The absolute financial impact for the company is capped in a way by the volume in Medicaid, and the 25% with the phase-in is certainly a better version of the bad policy.

對公司的絕對財務影響在某種程度上受到醫療補助數量的限制，分階段實施的 25% 無疑是糟糕政策的更好版本。

In any case, we advocate for leaving the Medicaid AMP cap at 100%.

無論如何，我們主張將 Medicaid AMP 上限保持在 100%。

Great.

偉大的。

And on pegilodecakin, so it's -- Dan mentioned we look forward to completing the study and sharing that data at the beginning of Q1.

關於 pegilodecakin，所以它是 - 丹提到我們期待在第一季度開始時完成研究並分享這些數據。

We are particularly looking forward to results in Cypress 1. So this is a patient population where we've added Keytruda in high expressors, so those are the PD-L1 over 50%.

我們特別期待 Cypress 1 的結果。所以這是一個患者群體，我們在高表達者中添加了 Keytruda，所以這些是 PD-L1 超過 50%。

So positive data from those trials would trigger additional lung trials, particularly potentially registration trials.

因此，這些試驗的陽性數據將引發額外的肺部試驗，尤其是潛在的註冊試驗。

We do continue to believe that the greatest opportunity for pegilodecakin is in lung cancer in the first-line setting and then also in later lines, whether following or a combination with other IO agents.

我們仍然相信，pegilodecakin 的最大機會是在一線治療肺癌中，然後是後期治療，無論是跟隨還是與其他 IO 藥物聯合使用。

And then the other area of great interest is renal cell cancer.

然後另一個令人感興趣的領域是腎細胞癌。

Both lung and renal had encouraging data in the Phase I study.

在 I 期研究中，肺和腎都有令人鼓舞的數據。

So as Dan mentioned, we do see this is a rapidly evolving landscape and have been working on our plans to optimize peg in that setting.

因此，正如 Dan 所提到的，我們確實看到這是一個快速發展的格局，並且一直在製定我們的計劃，以在該環境中優化掛鉤。

And so look forward to starting those studies at the end of the year as well as biomarker-driven studies in lung cancer and other tumor types.

因此，期待在今年年底開始這些研究以及肺癌和其他腫瘤類型的生物標誌物驅動研究。

So more to come on Cypress and pegilodecakin.

更多關於 Cypress 和 pegilodecakin 的信息。

Thanks, Umer.

謝謝，烏默爾。

Next caller, please, Cynthia.

請下一位來電者，辛西婭。

That will come from the line of Terence Flynn with Goldman Sachs.

這將來自高盛集團的特倫斯·弗林 (Terence Flynn)。

Maybe first, just would love some perspective on Trulicity growth in the second half given the dynamics you saw in the first half there.

也許首先，考慮到你在上半年看到的動態，我只想對下半年的 Trulicity 增長有一些看法。

And then can you help frame for us the high-dose data for Trulicity in the context of tirzepatide?

然後你能幫助我們在 tirzepatide 的背景下為 Trulicity 構建高劑量數據嗎？

And then my second question is on LOXO-292.

然後我的第二個問題是關於 LOXO-292。

You mentioned you're going to have a data presentation later this year.

您提到您將在今年晚些時候進行數據演示。

Just would love high-level thoughts on kind of the durability and safety, tolerability you're seeing to date.

只是會喜歡關於您迄今為止所看到的耐用性和安全性，耐受性的高級想法。

Thanks.

謝謝。

So we'll go to Enrique for the first question then Anne on 292.

所以我們先去 Enrique 回答第一個問題，然後去 Anne 在 292。

Very good.

很好。

Well, we are pleased with the performance of Trulicity.

好吧，我們對 Trulicity 的表現感到滿意。

We had sustained strong volume growth.

我們持續強勁的銷量增長。

We saw a 41% prescription growth in the United States when we look at the second quarter of '19 relative to the second quarter of '18.

當我們查看 19 年第二季度相對於 18 年第二季度時，我們看到美國的處方增長了 41%。

As we look at that, our sales growth was below that.

當我們看到這一點時，我們的銷售增長低於該水平。

Clearly, there was some price erosion.

顯然，有一些價格侵蝕。

The bigger pieces of this price erosion were the high rebate that were somewhat offset by modest list price increases.

這種價格侵蝕的更大部分是高回扣，但在一定程度上被適度的標價上漲所抵消。

And then about 7 points was the incremental funding of the doughnut hole going from 50% to 70%.

然後大約 7 個點是甜甜圈洞的增量資金從 50% 增加到 70%。

Clearly, when we look at relative to Q1, we did see good, continued sequential growth when we look at volume.

顯然，相對於第一季度，我們確實看到了良好的持續連續增長。

I think importantly, I think the fundamentals of the business are very strong as we look at both class growth of about 30% and when we look at the share performance.

我認為重要的是，當我們看到大約 30% 的類別增長和股票表現時，我認為業務的基本面非常強勁。

We do have, as you mentioned, significant catalyst with REWIND.

正如您所提到的，我們確實擁有 REWIND 的重要催化劑。

And of course, when it comes to the higher doses 3.0 and 4.5 milligrams for Trulicity, we are excited about the opportunities with both.

當然，當談到更高劑量的 3.0 和 4.5 毫克 Trulicity 時，我們對兩者的機會感到興奮。

When we think about tirzepatide, we sort of think of tirzepatide being in a completely different zip code when it comes to efficacy.

當我們想到 tirzepatide 時，我們有點認為 tirzepatide 在功效方面處於完全不同的郵政編碼中。

That's why we utilize the words of resetting expectations of treatment for people with type 2 diabetes when we look at both A1c and weight.

這就是為什麼當我們同時查看 A1c 和體重時，我們會使用重新設定對 2 型糖尿病患者的治療期望的話。

So we continue to be very excited about that particular asset.

因此，我們繼續對這一特定資產感到非常興奮。

And then with LOXO-292 -- thank you for that question.

然後是 LOXO-292——謝謝你的問題。

We will present, as you said, an update on the registrational data in the second half of 2019, one or more medical meetings.

正如您所說，我們將在 2019 年下半年，舉行一次或多次醫療會議上提供有關註冊數據的更新。

And that's in advance of the regulatory filing which is on track for the U.S. by the end of the year.

這是在年底前向美國提交的監管文件之前。

And we really do look forward to sharing that robust data set.

我們真的很期待分享這個強大的數據集。

It's now over 500 patients enrolled, and it's rolled across tumor types with RET fusions or mutations.

現在有超過 500 名患者入組，它涵蓋了具有 RET 融合或突變的腫瘤類型。

And we continue to be very excited by the profile as both a first and a best-in-class RET inhibitor.

作為首創和一流的 RET 抑製劑，我們繼續對這一概況感到非常興奮。

So LOXO-292 is highly potent.

所以 LOXO-292 非常有效。

We've seen robust response rates and exciting emerging durability as well and also a safety profile that doesn't carry the burden of cytopenia that can require costly supportive care interventions.

我們已經看到了強勁的反應率和令人興奮的新興耐用性，以及不承擔可能需要昂貴的支持性護理干預的血細胞減少負擔的安全性。

So again, enrollments continue to be strong.

因此，入學人數繼續保持強勁。

The Loxo team has continued to do a fantastic job on this program.

Loxo 團隊繼續在這個項目上做得非常出色。

And so we're very much looking forward to sharing that data at upcoming meetings.

因此，我們非常期待在即將召開的會議上分享這些數據。

Thanks, Anne.

謝謝，安妮。

Thank you, Terence.

謝謝你，特倫斯。

And next caller, please.

請下一位來電者。

That will be from the line of Andrew Baum with Citi.

這將來自花旗銀行的安德魯鮑姆。

First question, could you break down for us the initial versus subsequent lines of CDK 4/6 therapy for the entire market and give us some idea of whether you can use the MONARCH 2 data to cure formulary status under these commercial and Medicare plans for 2020?

第一個問題，您能否為我們分解整個市場 CDK 4/6 療法的初始線和後續線，並讓我們了解您是否可以使用 MONARCH 2 數據來治愈 2020 年這些商業和醫療保險計劃下的處方集狀態?

And then second, if we take the inflation cap as something that will happen within Medicare Part D, is it possible that, that could allay concerns about rising insurance premiums to allow rebate reform to research these parts of the proposal?

其次，如果我們將通脹上限視為將在醫療保險 D 部分中發生的事情，是否有可能減輕對保險費上漲的擔憂，從而允許退稅改革研究提案的這些部分？

Thanks.

謝謝。

We'll go to Anne for the initial question and then Dave for the inflation cap question.

我們先找安妮回答第一個問題，然後找戴夫回答通貨膨脹上限問題。

Well, thank you, Andrew.

好吧，謝謝你，安德魯。

And you've asked a really good question and thought about this carefully.

你問了一個非常好的問題並仔細考慮了這一點。

So in a trial like this, the reason it's so difficult to show a survival advantage is because of patients crossing over.

所以在這樣的試驗中，很難表現出生存優勢的原因是因為患者跨界。

And the fact that we were able to demonstrate significance at a preplanned interim confirms the strength of Verzenio and we do believe differentiates our product.

事實上，我們能夠在預先計劃的中期展示其重要性，這證實了 Verzenio 的實力，我們確實相信我們的產品與眾不同。

We do expect increased growth across all lines of therapy based on these results.

基於這些結果，我們確實預計所有治療線的增長都會增加。

And importantly, we will certainly share this data with those making access and treatment decisions.

重要的是，我們一定會與那些做出訪問和治療決定的人分享這些數據。

As we've heard, overall survival is the most important outcome, and it's the most subjective outcome as well.

正如我們所聽到的，總體存活率是最重要的結果，也是最主觀的結果。

So this really verifies the importance of Verzenio to achieve that best outcome for patients.

因此，這確實驗證了 Verzenio 對於為患者實現最佳結果的重要性。

And we've heard repeatedly from patients that overall survival is the most meaningful one for both patients and the physicians who are treating them.

我們從患者那裡反复聽到，對於患者和治療他們的醫生來說，總生存期是最有意義的。

This is an incredibly devastating disease, and women who are living with this disease want to do everything they can to be with their families as long as possible.

這是一種極具破壞性的疾病，患有這種疾病的女性希望盡其所能，盡可能地與家人在一起。

So we're really glad to have delivered this result for women with metastatic breast cancer.

所以我們真的很高興為患有轉移性乳腺癌的女性提供了這個結果。

Thank you, Anne.

謝謝你，安妮。

Thanks for the question, Andrew.

謝謝你的問題，安德魯。

And I think you're -- I didn't quite make it up, but I think you're talking about the Part D CPI cap as it relates to the impact on the rebate reform score.

而且我認為你是 - 我沒有完全彌補，但我認為你在談論 D 部分 CPI 上限，因為它與對回扣改革分數的影響有關。

Look, the Senate finance package, which is the sort of the leading integrated package we've seen, generates a huge amount of savings to the government, most of which does not go back to the patients.

看，參議院財政一攬子計劃，這是我們所見過的領先的綜合一攬子計劃，為政府節省了大量資金，其中大部分並沒有返還給患者。

This is our primary issue with it.

這是我們的主要問題。

Even the reform within Part D that is on the table, the AAF proposal pretty much pays for itself, maybe generates a little bit of surplus actually.

即使是擺在桌面上的 D 部分內的改革，AAF 提案也幾乎為自己付出了代價，實際上可能會產生一點盈餘。

So the question we're posting to policymakers is, how do we reinvest that?

所以我們向政策制定者提出的問題是，我們如何再投資？

For, yes, premium stability.

因為，是的，優質的穩定性。

Premiums are already extremely low in Part D and have been stable for years.

D 部分的保費已經非常低，並且多年來一直保持穩定。

But more importantly, direct relief at the pharmacy counter, more relief than this package delivers with various proposals.

但更重要的是，在藥房櫃檯直接救濟，比這個套餐提供的各種建議更救濟。

One of those is -- as you indicate, is to go back to the idea of passing through some or all of negotiated discounts with seniors and indexing their copayments, their deductible to net pricing, not list.

其中之一是 - 正如您所指出的那樣，是回到與老年人協商的部分或全部折扣並將他們的共付額索引，他們的扣除額為淨定價，而不是列出的想法。

I think pretty much everyone who's close to me, you think this is a good idea.

我想幾乎所有與我親近的人，你都認為這是個好主意。

As you point out, the issue has been the score.

正如你所指出的，問題是分數。

Now if we can find it to Part D and make it in connection with the rest of the finance committee package, I think there's a huge potential to achieve all of these goals.

現在，如果我們能在 D 部分找到它並將其與財務委員會一攬子計劃的其餘部分聯繫起來，我認為實現所有這些目標的潛力巨大。

One could also look at phases, phasing it in or even partial rebate pass-through stepping up through time.

人們還可以查看階段，逐步進行，甚至部分回扣通過時間逐步增加。

So all these ideas are ideas we've had as pharma that we're actively pushing on.

所以所有這些想法都是我們作為製藥公司的想法，我們正在積極推動。

And maybe the main thing about all this is although this package got a lot of ink, we're far from the finish line here.

也許這一切的主要內容是，雖然這個包裹有很多墨水，但我們離終點還很遠。

And there'll be a lot of discussion probably with policies we really don't like and some we like better, like the one you're suggesting.

可能會有很多關於我們真的不喜歡的政策以及我們更喜歡的政策的討論，比如你建議的政策。

And we'll do our best to try to shape this into something workable that addresses the fundamental issue, which is out-of-pocket costs for people who use innovative medicines.

我們將盡最大努力將其塑造成可行的方案，解決根本問題，即使用創新藥物的人的自付費用。

Thank you.

謝謝你。

Andrew, thanks for the question.

安德魯，謝謝你的問題。

Cynthia, next caller, please.

辛西婭，請下一位來電。

That will be from the line of Steve Scala with Cowen.

這將來自 Steve Scala 和 Cowen 的路線。

I have a couple.

我有一對。

First on tanezumab, how would you describe your level of confidence that the 2.5-milligram can be approved in OA?

首先關於 tanezumab，您如何描述您對 2.5 毫克可用於 OA 的信心水平？

Why are you no longer filing in chronic lower back pain?

為什麼你不再患慢性腰痛？

And where does cancer pain stand?

癌症疼痛在哪裡？

So that's the first question.

所以這是第一個問題。

And then secondly, AbbVie's IL-23 SKYRIZI seems to be off to a great start.

其次，艾伯維的 IL-23 SKYRIZI 似乎開了個好頭。

And AbbVie specifically said they were taking share from IL-17s.

艾伯維特別表示，他們正在從 IL-17 中分一杯羹。

So just curious what you're seeing.

所以只是好奇你看到了什麼。

Thanks, Steve.

謝謝，史蒂夫。

Dan, we'll have you take the tanezumab question, and Josh, if you can handle SKYRIZI.

Dan，如果你能處理 SKYRIZI，我們會讓你回答 tanezumab 問題，還有 Josh。

Yes.

是的。

Thanks, Steve, for the question on the various tanezumab indications.

謝謝史蒂夫，關於各種 tanezumab 適應症的問題。

In a sense, you're right in the order that you put them in, which is that we sort of prioritize based on the data that we have and the overall benefit/risk in each of those populations.

從某種意義上說，按照您放置它們的順序，您是對的，也就是說，我們根據我們擁有的數據和每個人群的總體收益/風險來確定優先級。

So based on that as well as the unmet medical need in osteoarthritis, we prioritized moving that forward with regulators.

因此，基於這一點以及骨關節炎方面未得到滿足的醫療需求，我們優先與監管機構一起推動這一進程。

Overall, we wouldn't be proceeding with regulatory submissions and announcing that we're proceeding unless we had confidence in the overall benefit/risk that this medicine provides in that population.

總體而言，除非我們對這種藥物在該人群中提供的總體益處/風險有信心，否則我們不會繼續提交監管文件並宣布我們正在繼續進行。

That's based on the trials that we have recently disclosed.

這是基於我們最近披露的試驗。

It's also based on the totality of the evidence.

它也是基於證據的整體性。

And that's a decision that we've come to together with our partners at Pfizer.

這是我們與輝瑞的合作夥伴共同做出的決定。

The chronic lower back pain, we've decided not to pursue at this time for almost exactly the same reasons given the unmet medical need in that population and the benefit/risk in that population.

考慮到該人群未得到滿足的醫療需求以及該人群的益處/風險，我們決定此時不考慮慢性腰痛，原因幾乎完全相同。

Cancer pain is the third here in line, and we don't have that trial.

癌症疼痛是排在第三位的，我們沒有那個試驗。

It's taking a bit of time to read out.

閱讀需要一些時間。

And so it's hard to comment on what the benefit/risk will be there given that we don't have that data yet.

因此，鑑於我們還沒有這些數據，很難評論會有什麼好處/風險。

On SKYRIZI, it's Josh.

在 SKYRIZI 上，是喬希。

The launch is really in line with what we expected it to be.

此次發布確實符合我們的預期。

It's a good launch.

這是一個很好的啟動。

If you look at it relative to Taltz and time normalized, that Taltz is a little bit better in terms of prescription trends.

如果你看它相對於 Taltz 和時間標準化，Taltz 在處方趨勢方面要好一點。

But in terms of what we see in the marketplace right now, Steve, first is really, we're pleased with Taltz' performance in the U.S. in Q2.

但就我們目前在市場上看到的情況而言，史蒂夫首先是真的，我們對 Taltz 在第二季度在美國的表現感到滿意。

We saw TRx volume growth of 61%, and really, we see share growth.

我們看到 TRx 交易量增長了 61%，實際上，我們看到了份額增長。

Really, as we look at SKYRIZI, we see -- it looks like share coming primarily from the STELARA in the IL-12/23 class, maybe some from Cosentyx.

真的，當我們看到 SKYRIZI 時，我們看到了——看起來份額主要來自 IL-12/23 級的 STELARA，可能來自 Cosentyx。

But our growth continues, and we feel good about the share performance that we're seeing.

但我們的增長仍在繼續，我們對所看到的股票表現感覺良好。

Of course, for later this year, we're looking forward to releasing data on our head-to-head trial against Tremfya and think that'll be an important competitive positioning for us.

當然，今年晚些時候，我們期待發布與 Tremfya 的正面交鋒試驗數據，並認為這對我們來說將是一個重要的競爭定位。

So we -- overall, the biggest thing that we need to see is continued growth in the class.

所以我們 - 總的來說，我們需要看到的最重要的事情是班級的持續增長。

And I think still majority of prescriptions are happening in the TNF class.

而且我認為大多數處方仍然發生在 TNF 類中。

So I think anything on the -- both the 17 and 23 classes are able to shift to the better, more modern treatments is good for patients and it'll be good for Taltz.

所以我認為 17 和 23 班都能夠轉向更好、更現代的治療方法，這對患者有好處，對 Taltz 也有好處。

Thanks, Josh.

謝謝，喬希。

Thanks, Steve.

謝謝，史蒂夫。

Next caller, please.

請下一位來電者。

Go to the line of David Risinger with Morgan Stanley.

與摩根士丹利一起前往大衛·瑞辛格的行列。

So I have 2 questions, please.

所以我有2個問題，拜託。

First, Dave, you have mentioned that out-of-pocket costs for people who use innovative medicines are a challenge.

首先，戴夫，你提到使用創新藥物的人的自付費用是一個挑戰。

But could you talk about what the industry is doing, if anything, with respect to such costs outside of Part D?

但是，您能否談談該行業在 D 部分之外的此類成本方面正在做什麼（如果有的話）？

Because the government's actions will likely only apply to Part D. That's where the government can affect drugs.

因為政府的行動可能只適用於 D 部分。這就是政府可以影響藥物的地方。

And the industry has a major public relations problem with the majority of the population that is outside of Medicare Part D that struggle with out-of-pocket costs.

該行業與醫療保險 D 部分以外的大多數人口存在重大公共關係問題，他們在自付費用方面苦苦掙扎。

So is the industry doing anything, i.e., with the Chamber of Commerce or with major employer groups to try to change the dynamic of the out-of-pocket cost challenge?

那麼該行業是否正在採取任何措施，即與商會或主要雇主團體合作，試圖改變自付費用挑戰的動態？

And one final thing, I'll just make a statement, which is that it does seem that the industry has not been able to overcome the unfair treatment of drug coverage, i.e., the fact that people pay too much out-of-pocket relative to the out-of-pocket costs for other health care utilizations such as physician visits, hospital visits, et cetera.

最後一件事，我要聲明一下，該行業似乎確實無法克服藥物承保的不公平待遇，即人們自付費用的事實其他醫療保健用途的自付費用，例如就診、就診等。

So anyway, sorry for the long diatribe, but I did want to understand the industry's agenda outside of government reimbursement.

所以無論如何，很抱歉長時間的謾罵，但我確實想了解政府報銷之外的行業議程。

And then second, could you just talk about Lilly's evaluation of oral GLP-1s as a potential pipeline product opportunity?

其次，您能否談談禮來（Lilly）對口服 GLP-1 作為潛在管道產品機會的評估？

Thanks, Dave.

謝謝，戴夫。

We'll have -- Dave will take your first question then Dan will talk about the GLP-1 oral pipeline.

我們將 - Dave 將回答您的第一個問題，然後 Dan 將談論 GLP-1 口服管道。

Yes.

是的。

Thanks, Dave, for the question.

謝謝，戴夫，這個問題。

A lot in there, but I think in general, we agree that -- I mean we need to improve the rhetoric in the -- around the industry.

那裡有很多，但我認為總的來說，我們同意 - 我的意思是我們需要改善 - 圍繞行業的言論。

We're working hard to do that.

我們正在努力做到這一點。

But mostly, we need to improve the experience of patients at the pharmacy counter.

但最重要的是，我們需要改善患者在藥房櫃檯的體驗。

You correctly point out that a lot of the discussion is about the government programs, but for Lilly's business, more than half our business in the U.S. is commercially reimbursed and what are we doing there.

您正確地指出，很多討論都是關於政府計劃的，但對於禮來的業務，我們在美國的業務有一半以上是商業報銷的，我們在那裡做什麼。

That is an area of increasing focus for us, and I think there's probably 4 things that I will point to that we're both doing and ramping up.

這是我們越來越關注的一個領域，我認為我可能會指出我們正在做和加速的四件事。

The first is how we design and implement our own health care coverage.

首先是我們如何設計和實施我們自己的醫療保險。

As a health care company, I think we can begin to shape the market by our own purchasing behavior.

作為一家醫療保健公司，我認為我們可以開始通過我們自己的購買行為來塑造市場。

And then I think we have -- without going through it here, one of the most progressive policies for our own employees as it relates to drug cover, including first our drug coverage on products like insulin and the way the deductible gets funded, et cetera.

然後我認為我們有 - 沒有在這裡討論它，這是我們自己的員工最先進的政策之一，因為它與藥物保險有關，包括首先我們對胰島素等產品的藥物保險以及免賠額獲得資助的方式等等.

And these are all positions, having years of experience doing it, we're in a position to recommend to our peer companies as well as to insurance providers as best practice.

這些都是職位，擁有多年的經驗，我們可以向同行公司以及保險提供商推薦最佳實踐。

As you know probably, recently, there was an IRS ruling that is quite an important, maybe subtle thing that allows for the first time clarity around the question of whether medicines can be classified as a preventative treatment under HRA/HSA designs in high-deductible plans.

正如您可能知道的那樣，最近，美國國稅局的一項裁決非常重要，也許是微妙的事情，它首次明確了藥物是否可以在 HRA/HSA 設計下被歸類為高免賠額的預防性治療的問題計劃。

And the answer from the IRS is yes, they can.

美國國稅局的回答是肯定的，他們可以。

So we'll use that as I think a new point to help those that are purchasing insurance products in the commercial market that they can design plans that have first dollar coverage, 0 out-of-pocket for important essential medicines, in particular in diabetes for us but also other categories as well that affect millions of people.

因此，我們將使用這一點，因為我認為一個新的觀點可以幫助那些在商業市場上購買保險產品的人，他們可以設計具有第一美元承保範圍的計劃，重要的基本藥物自付費用為 0，尤其是糖尿病對我們來說，還有其他影響數百萬人的類別。

Thirdly, value-based pricing is something Lilly is taking a leading position on.

第三，基於價值的定價是禮來公司處於領先地位的東西。

Although it's been stubborn in government segments, we're making enormous strides in commercial markets.

儘管它在政府部門一直很頑固，但我們在商業市場上取得了長足的進步。

And this -- while it doesn't directly translate to this year out-of-pocket costs at the pharmacy counter, I think it does allow us to both demonstrate the value of our medicines and share the risk and benefit of those medicines with self-insured employers.

而這——雖然它並沒有直接轉化為今年藥房櫃檯的自付費用，但我認為它確實讓我們既能展示我們的藥物的價值，又能與自己分享這些藥物的風險和益處-有保險的雇主。

We're having a lot of success with this, and I think it does begin to shift the discussion pretty dramatically around medicines as a cost versus medicines as a solution.

我們在這方面取得了很大的成功，我認為它確實開始極大地改變圍繞藥物作為成本與藥物作為解決方案的討論。

And that's important.

這很重要。

Finally, there are state-based efforts that are seeking to regulate the commercial marketplace.

最後，還有一些基於國家的努力正在尋求規範商業市場。

I think you'll see pharma and Lilly increasingly active in those debates, Colorado being one of them that's out there.

我想你會看到製藥公司和禮來公司在這些辯論中越來越活躍，科羅拉多州就是其中之一。

And as the playing field shifts from a federal debate during an election year where, let's be honest, very little will probably happen, the states may be a center for action in 2020.

隨著競爭環境從選舉年的聯邦辯論轉移，老實說，幾乎不會發生什麼，各州可能成為 2020 年的行動中心。

And we'll be ready to engage and advocate for policies that help patients with the innovative medicines there.

我們將準備好參與並倡導幫助患者使用創新藥物的政策。

So a lot in my answer, but I think you pointed out a good thing here, which is commercial market matters for a lot of companies, including Lilly, and we need to address those inefficiencies as well.

在我的回答中說了很多，但我認為你在這裡指出了一件好事，這對包括禮來在內的許多公司來說都是商業市場問題，我們也需要解決這些低效率問題。

Thanks, Dave.

謝謝，戴夫。

Dan?

擔？

Great.

偉大的。

Thanks for your question on oral incretins.

感謝您關於口服腸促胰島素的問題。

It's obviously an area of interest for us.

這顯然是我們感興趣的一個領域。

And I'd maybe speak generally about our strategy here, which is that we want to be able to offer oral incretin therapy that meets sort of 1 of 2 criteria.

我可能會在這里大致談談我們的策略，即我們希望能夠提供符合 2 個標準之一的口服腸促胰島素治療。

First, it could have a significantly improved bioavailability versus what's currently under development.

首先，與目前正在開發的產品相比，它可以顯著提高生物利用度。

And that's important because that will translate to more convenient experience for a patient, more convenient dosing with more reliable advocacy.

這很重要，因為這將為患者帶來更方便的體驗，更方便的給藥和更可靠的宣傳。

The other option is to offer greater efficacy in an oral product than the currently available once-weekly GLP-1s.

另一種選擇是在口服產品中提供比目前可用的每週一次的 GLP-1 更高的功效。

So we're pursuing those 2 tactics with different approaches.

所以我們正在用不同的方法來追求這兩種策略。

So to get something that's very highly bioavailability, you need to move to small molecules.

因此，要獲得生物利用度非常高的東西，您需要轉向小分子。

And so here, we have a program which is characterized by our molecule adjustment into Phase I this quarter, the -- we call it the GLP-1 NPA or non-peptide agonist, which is the product that was invented by Chugai, and we partnered with them on that.

所以在這裡，我們有一個程序，其特點是我們在本季度將分子調整到第一階段，我們稱之為 GLP-1 NPA 或非肽激動劑，這是 Chugai 發明的產品，我們與他們合作。

So we're excited to see Phase I data from that.

所以我們很高興看到第一階段的數據。

We'll quickly learn what kind of bioavailability we get, and that'll determine how we pursue that project.

我們將很快了解我們獲得了什麼樣的生物利用度，這將決定我們如何開展該項目。

The other avenue to get better efficacy than currently available injectables really relies on next-generation incretins.

獲得比目前可用的注射劑更好功效的另一個途徑確實依賴於下一代腸促胰島素。

So these are bispecific molecules like our tirzepatide GIP/GLP where we are seeking to get the peptide to become orally bioavailable.

因此，這些是雙特異性分子，例如我們的 tirzepatide GIP/GLP，我們正在尋求使肽成為口服生物可利用的。

And we have a number of approaches to accomplish that and look forward to moving those programs into the clinic soon.

我們有多種方法可以實現這一目標，並期待很快將這些項目推向臨床。

Thanks, Dan, and thank you, Dave.

謝謝，丹，謝謝你，戴夫。

We will go to the line of Seamus Fernandez with Guggenheim.

我們將與古根海姆一起前往 Seamus Fernandez 的路線。

So just 2 very quick questions.

所以只有兩個非常快速的問題。

First on Verzenio in HER2-positive disease, can you just give us a quick sense of Lilly's definition of clinically meaningful if the data is registrational?

首先是關於 HER2 陽性疾病的 Verzenio，如果數據是註冊的，您能否讓我們快速了解 Lilly 對臨床意義的定義？

And then just maybe give us an estimated market size or a path just thinking about the market size.

然後也許只是給我們一個估計的市場規模或只考慮市場規模的路徑。

And then separately, on Taltz gross to net, can you just give us the gross to net currently?

然後另外，關於 Taltz 總淨值，你能不能給我們目前的總淨值？

And given the company's need to reposition the product for growth in RA, should we anticipate further price concessions in the next formulary negotiation cycle?

鑑於公司需要重新定位產品以實現 RA 的增長，我們是否應該預期在下一個處方談判週期中會出現進一步的價格優惠？

Thanks, Seamus.

謝謝，西莫。

Anne, we'll go to you for the Verzenio question then Josh will take the Taltz question.

安妮，我們會去找你回答 Verzenio 的問題，然後 Josh 會回答 Taltz 的問題。

Yes, Seamus.

是的，西莫。

Thanks for that question on the HER2-positive data.

感謝關於 HER2 陽性數據的問題。

And as Dan mentioned in his opening remarks, we're extremely pleased to have a positive result in that study.

正如丹在開場白中提到的那樣，我們非常高興在這項研究中取得了積極的成果。

And so as you mentioned, this is the first randomized controlled study to have positive results in HER2-positive breast cancer.

正如你所提到的，這是第一個在 HER2 陽性乳腺癌中取得陽性結果的隨機對照研究。

And this has been a very difficult-to-treat population.

這是一個非常難以治療的人群。

And so finding opportunities for them to avoid chemotherapy has certainly been the goal of this study.

因此，為他們尋找避免化療的機會當然是這項研究的目標。

And so we do believe that the positive result and the meeting of the primary endpoint of PFS are clinically meaningful.

因此，我們確實相信 PFS 的陽性結果和主要終點的滿足具有臨床意義。

And while I can't show the specifics of the data and we'll be presenting that at a scientific meeting later this year, we do believe that it's clinically relevant for patients, particularly those that want to avoid chemotherapy in this setting.

雖然我無法展示數據的具體細節，我們將在今年晚些時候的一次科學會議上介紹這一點，但我們確實相信它與患者臨床相關，尤其是那些希望在這種情況下避免化療的患者。

We do -- the next step really is to discuss this data.

我們這樣做了——下一步真的是討論這些數據。

And that's our plan, to discuss this data with regulators as we share at the scientific meetings.

這就是我們的計劃，在科學會議上與監管機構討論這些數據。

So I can't comment any further at this time on regulatory strategy.

因此，我目前無法就監管策略發表任何進一步評論。

On the market size, so as you probably know, this is about 15% to 20% of breast cancer.

就市場規模而言，你可能知道，這大約是乳腺癌的 15% 到 20%。

So this is not an insubstantial market.

因此，這不是一個虛無縹緲的市場。

So we do believe this is a significant opportunity as we go forward for these patients who have that particularly hard-to-treat type of breast cancer.

因此，我們確實相信這是一個重要的機會，因為我們為這些患有特別難以治療的乳腺癌類型的患者前進。

So again, together with the overall survival data and the robust result that we had in the China registration study, I think all 3 just reinforce the strength that Verzenio brings.

因此，再一次，連同我們在中國註冊研究中獲得的總體生存數據和穩健的結果，我認為所有 3 項都加強了 Verzenio 帶來的力量。

And again, the only CDK 4/6 that has continuous dosing, the only one with a monotherapy indication, and it's continued to help patients, particularly those with a poor diagnosis.

再一次，唯一一個連續給藥的 CDK 4/6，唯一一個有單一療法適應症的，它繼續幫助患者，特別是那些診斷不佳的患者。

So I think we're very pleased to share these updates on Verzenio today.

所以我認為我們很高興今天在 Verzenio 上分享這些更新。

And Seamus, on Taltz and price and gross to net, really in the second quarter, neither of those were major factors in terms of U.S. growth.

而 Seamus，在 Taltz 和價格和總淨額方面，實際上在第二季度，這些都不是美國增長的主要因素。

Our price and gross-to-net rates have remained pretty steady.

我們的價格和總淨利率保持相當穩定。

As we mentioned in Q1, about 2/3 of Taltz prescriptions right now in the U.S. are reimbursed, and that really didn't change in Q2.

正如我們在第一季度提到的，目前美國約有 2/3 的 Taltz 處方得到了報銷，這在第二季度確實沒有改變。

We're pleased with the share performance in psoriasis.

我們對牛皮癬的股價表現感到滿意。

I think as you mentioned in the room space, we're looking forward to indications in AxSpA, which we think will make us more competitive and open up significant growth opportunity there.

我認為正如您在房間空間中提到的那樣，我們期待 AxSpA 的跡象，我們認為這將使我們更具競爭力並在那裡開闢顯著的增長機會。

And we're focused on access, and we would like to see that improve.

我們專注於訪問，我們希望看到這種改進。

But really, in terms of price and availability today, not significant changes in the first half of this year.

但實際上，就今天的價格和可用性而言，今年上半年沒有重大變化。

And maybe just to comment to add to that, PsA is the indication, not RA.

也許只是為了補充一點，PsA 是指徵，而不是 RA。

I think we see -- the way we see this is these additional indications actually will enhance our leverage in payer access discussions, not erode it.

我想我們看到了——我們看到這些額外的跡象實際上將增強我們在支付者訪問討論中的影響力，而不是削弱它。

So actually, I think it works the opposite way from the way your question was phrased.

所以實際上，我認為它的工作方式與您提出問題的方式相反。

The more volume we can build on PsA, the more indications like AxSpa we get, the more unique the product is and the more leverage we gain.

我們可以在 PsA 上建立的數量越多，我們獲得的 AxSpa 等指標就越多，產品就越獨特，我們獲得的影響力就越大。

So I think we're optimistic about both the growth of the product but also the pricing power in this market.

所以我認為我們對產品的增長和這個市場的定價能力都很樂觀。

Seamus, thanks for your questions.

Seamus，謝謝你的提問。

We will go to the line of Chris Schott with JPMorgan.

我們將與摩根大通一起前往 Chris Schott。

First one is, there seems to be lingering investor concerns about Trulicity and GLP-1 pricing as we look out to 2020 and beyond with the launch of oral sema.

第一個是，隨著口腔 sema 的推出，我們展望 2020 年及以後，投資者對 Trulicity 和 GLP-1 定價的擔憂似乎揮之不去。

Can we maybe just get your latest thoughts in terms of how you see payers reacting to new entrants in the market?

我們能否就您如何看待付款人對市場新進入者的反應了解您的最新想法？

And should we be anticipating a more challenging pricing environment for Trulicity going forward?

我們是否應該期待 Trulicity 未來的定價環境更具挑戰性？

So that's the first question.

所以這是第一個問題。

Second question was on tax.

第二個問題是關於稅收的。

I think you mentioned some discrete items and a lower tax rate this year.

我想你今年提到了一些離散項目和較低的稅率。

Just any thoughts about how we should think about normalized tax rate for Lilly as we look beyond 2019?

在我們展望 2019 年之後，關於我們應該如何考慮禮來公司的標準化稅率的任何想法？

Thank you.

謝謝你。

So Enrique then we'll go to Josh for the tax question.

那麼Enrique 那麼我們將請Josh 回答稅收問題。

It's -- appreciate the question.

這是 - 感謝這個問題。

I know we get this question often on Trulicity and the outlook of price.

我知道我們經常在 Trulicity 和價格前景方面遇到這個問題。

And I'm unable to provide that, but I think it's important to think about the value that Trulicity is delivering today and the incremental value that we can deliver as we think about REWIND, as we can think about the higher doses that Trulicity will be launching because all of that is basically additional value that the product would be providing.

我無法提供這一點，但我認為重要的是要考慮 Trulicity 今天提供的價值以及我們在考慮 REWIND 時可以提供的增量價值，因為我們可以考慮 Trulicity 的更高劑量推出，因為所有這些基本上都是產品將提供的附加價值。

We think we have a strong foundation with the performance of the product.

我們認為我們對產品的性能有著堅實的基礎。

I'm not going to speculate on how Novo would price their product and what the potential responses from payers may be.

我不會推測 Novo 將如何定價他們的產品以及付款人的潛在反應可能是什麼。

I think on tax rate, our prior guidance for this year on a non-GAAP basis was between 14% and 15% as we reduced that by 1 point given the discrete tax benefits that we saw in the second quarter.

我認為在稅率方面，我們在非公認會計原則基礎上對今年的先前指導在 14% 和 15% 之間，因為我們將其降低了 1 個百分點，因為我們在第二季度看到了離散的稅收優惠。

I think from a long-term perspective, that 14% to 15% range is reasonable.

我認為從長遠來看，14% 到 15% 的範圍是合理的。

One of the things that's a swing factor here is the calculation around GILTI.

這裡的一個搖擺因素之一是圍繞 GILTI 的計算。

And depending on where and how our income flows, that again can move that a little bit.

並且取決於我們的收入流向何處以及如何流動，這又可以稍微改變一點。

But we're comfortable in the sort of low to mid-teens as a sustainable rate given the tax structure that we have today in the U.S. So as long as that's maintained, we think we can maintain it somewhere in that range with -- again, on any given year, depending on where we're launching, how sales are moving, we could see a 100 basis point swing one way or another.

但是考慮到我們今天在美國擁有的稅收結構，我們對處於低到中十幾歲的可持續稅率感到滿意。因此，只要維持這一點，我們認為我們可以將其維持在該範圍內的某個地方——再次，在任何一年，根據我們在哪裡推出，銷售情況如何，我們可能會看到 100 個基點以一種或另一種方式擺動。

Thanks, Josh.

謝謝，喬希。

Chris, thanks for your questions.

克里斯，謝謝你的提問。

We will go to the line of Tim Anderson from Wolfe Research.

我們將轉到 Wolfe Research 的 Tim Anderson 的路線。

On Trulicity, where does the Lilly Diabetes team expect that Novo's oral semaglutide's source of business will come from in terms of drug classes?

在 Trulicity 上，禮來糖尿病團隊預計諾和口服索馬魯肽在藥物類別方面的業務來源將來自哪裡？

And when that product launches, do you think that, that will lead to a slowdown in the scripts for Trulicity that will be palpable by investors?

當該產品推出時，您是否認為這會導致 Trulicity 腳本的放緩，而投資者可以感受到這一點？

Or is the class growth high enough such that Trulicity may not really budge at all?

或者班級增長是否足夠高，以至於 Trulicity 可能根本不會真正讓步？

And then second question, again, on reform.

然後是關於改革的第二個問題。

Sorry, Dave.

對不起，戴夫。

I was surprised to learn from someone who's well-informed in this area that AARP was a key stakeholder in killing the proposed rebate reform because of their alignment with the drug industry where they supposedly get something like half their funding.

我很驚訝地從一個在該領域消息靈通的人那裡得知，美國退休人員協會是扼殺提議的退稅改革的關鍵利益相關者，因為他們與製藥行業保持一致，他們本應獲得大約一半的資金。

My question is whether you think rebate reform could still be brought back onto the table?

我的問題是，您是否認為退稅改革仍然可以重新提上日程？

Or is that permanently off the table?

還是永久不在桌面上？

Okay, thanks.

好的謝謝。

So Enrique for Trulicity and then Dave for the policy question.

所以 Enrique 代表 Trulicity，然後 Dave 代表政策問題。

Yes.

是的。

It's honestly very difficult to speculate given that we will need to see -- when we think of a source of business, we will need to see basically how Novo would price their product, what type of placement, what is the message and so forth and so on.

老實說，很難推測，因為我們需要看到——當我們考慮業務來源時，我們基本上需要看到 Novo 將如何定價他們的產品，放置什麼類型，信息是什麼等等，很快。

I think what we see, though, I think just generally when we think about diabetes is that patients do tend to go to an oral first, right, as we think about orals.

不過，我認為我們所看到的，當我們想到糖尿病時，我認為通常情況下，患者確實傾向於首先進行口腔治療，對，就像我們想到口腔一樣。

So right now, I think the product that we basically have that we are commercializing is Jardiance, which has an incredible evidence and incredible benefit.

所以現在，我認為我們正在商業化的基本上擁有的產品是 Jardiance，它具有令人難以置信的證據和令人難以置信的好處。

My sense is depending on how they position their product, how they price this product, that's going to be a pretty big barrier for them to overcome.

我的感覺取決於他們如何定位他們的產品，他們如何為這個產品定價，這將是他們克服的一個相當大的障礙。

I think we are extremely well positioned with the product we're investing well behind, and we have a great partner on Boehringer Ingelheim to make that extremely successful.

我認為我們在我們投資的產品方面處於非常有利的位置，我們在勃林格殷格翰有一個很好的合作夥伴，可以讓這件事取得巨大成功。

Dave?

戴夫？

Yes, okay.

是的，好的。

Thanks for the question, Tim.

謝謝你的問題，蒂姆。

I think I guess we can declare the experiment of heading off questions in advance in prepared remarks, that we missed our primary endpoint.

我想我想我們可以在準備好的評論中宣布提前結束問題的實驗，我們錯過了我們的主要終點。

Anyway, I think it is true, AARP was a strong opponent of rebate reform.

無論如何，我認為這是真的，AARP 是退稅改革的強烈反對者。

We can all speculate why, but it's also true that the majority of their revenue, I think more than half, comes from royalties from the Part D program.

我們都可以推測原因，但他們的大部分收入（我認為超過一半）來自 D 部分計劃的版稅，這也是事實。

So easy to get cynical when you spend time in Washington.

當您在華盛頓度過時光時，很容易變得憤世嫉俗。

That said, we still think it's a good idea.

也就是說，我們仍然認為這是一個好主意。

Is it possible to come back?

有可能回來嗎？

Probably in some other form.

可能是其他形式。

I think the broad-based pulling of the Anti-Kickback Statute gets harder because of the way the scoring happened and the politics around it.

我認為由於計分發生的方式和圍繞它的政治，反回扣法規的廣泛拉動變得更加困難。

But as was mentioned by Dave Risinger earlier or perhaps it was Andrew that inside of a Part D benefit redesign, the idea of patients linking out-of-pocket costs to something other than list price is a good idea.

但正如 Dave Risinger 之前提到的，或者可能是 Andrew，在 D 部分福利重新設計中，患者將自付費用與標價以外的其他東西聯繫起來的想法是一個好主意。

And there's a sliding scale.

還有一個滑動比例。

We don't have to go all the way.

我們不必一路走。

That could change the scoring and make it more affordable and create a model for insurance design in the commercial market and other segments.

這可能會改變評分並使其更實惠，並為商業市場和其他領域的保險設計創造一個模型。

So we're far from giving up on this idea.

所以我們遠沒有放棄這個想法。

And as you know, given a retail portfolio like Lilly's with big gross-to-net spreads, over 50% on average, across our portfolio, this is the single quickest and most efficacious way to save patients money at the point of sale and restructure the incentives of the payers to work on behalf of patients directly versus work on behalf of all beneficiaries, including non-patients, which is kind of how it's set up today.

如您所知，鑑於禮來（Lilly）這樣的零售投資組合在我們的投資組合中具有較大的總淨利差（平均超過 50%），這是在銷售點和重組時為患者節省資金的最快捷、最有效的方法付款人直接代表患者工作而不是代表所有受益人（包括非患者）工作的激勵措施，這就是今天的設置方式。

So we've got a long way to go in this debate, and this is an idea we haven't let go of.

所以我們在這場辯論中還有很長的路要走，這是一個我們沒有放棄的想法。

Thanks, Dave.

謝謝，戴夫。

Tim, thanks for your questions.

蒂姆，謝謝你的提問。

We will go to the line of Louise Chen with Cantor Fitzgerald.

我們將與 Cantor Fitzgerald 一起前往 Louise Chen 的路線。

So my first question is on tirzepatide.

所以我的第一個問題是關於替西帕肽。

I wanted to ask you what you think -- or what level of GI side effect is considered acceptable by physicians?

我想問你你的想法——或者醫生認為什麼水平的胃腸道副作用是可以接受的？

And then on your NASH and obesity product, how do you plan to differentiate your product from others in development or those that have failed?

然後在您的 NASH 和肥胖症產品上，您打算如何將您的產品與其他正在開發或失敗的產品區分開來？

And then my second question is on the CGRPs, the potential entry of these oral CGRPs.

然後我的第二個問題是關於 CGRP，這些口頭 CGRP 的潛在進入。

And do you think the prophylactic ones would interfere with the growth of the injectable CGRPs?

您認為預防性藥物會干擾可注射 CGRP 的生長嗎？

And then what about the acute CGRPs, if there's any overlap there with your products?

如果與您的產品有任何重疊，那麼急性 CGRP 呢？

Thanks.

謝謝。

We'll go to Enrique for the question on tirzepatide, and then, Dan, if you want to talk about the CGRPs.

如果您想談談 CGRP，我們將向 Enrique 詢問關於 tirzepatide 的問題，然後是 Dan。

We already have an excellent in-market experiment here because we've seen the success of GLP-1.

我們已經在這裡進行了出色的市場試驗，因為我們已經看到了 GLP-1 的成功。

So we know that with the level of side effects of the GLP-1 class, we can have significant success.

所以我們知道，以 GLP-1 類的副作用水平，我們可以取得顯著的成功。

We do believe that we are not going to be trading off.

我們確實相信我們不會進行交易。

In the case of tirzepatide, we will get the additional efficacy, and we believe that we will have a comparable side effect profile to the GLP-1 class.

在 tirzepatide 的情況下，我們將獲得額外的療效，我們相信我們將有與 GLP-1 類相當的副作用。

When it comes to NASH and obesity, honestly, we are betting to be a best-in-class product.

當談到 NASH 和肥胖症時，老實說，我們打賭成為一流的產品。

We're not betting to be first-in-class or -- we are thinking that we are going to reset the expectations of what's possible in both obesity and NASH with tirzepatide.

我們不打賭要成為一流的，或者 - 我們認為我們將重新設定對 tirzepatide 在肥胖和 NASH 中可能發生的事情的期望。

Thanks, Enrique.

謝謝，恩里克。

Dan?

擔？

Great.

偉大的。

Thanks for your question on the CGRP market and the potential impact of oral CGRPs coming to market.

感謝您就 CGRP 市場以及口服 CGRP 上市的潛在影響提出問題。

Of course, as you know and pointed out, the injectable CGRPs, like our Emgality, are approved and marketed for prevention, for prophylaxis for migraine, whereas the initial indication for the oral CGRPs is likely to be in the acute treatment or abortive use of migraine.

當然，正如您所知道並指出的那樣，可注射 CGRP，如我們的 Emgality，已被批准並上市用於預防和預防偏頭痛，而口服 CGRP 的初始適應症可能是急性治療或流產使用偏頭痛。

I think there's a couple of questions about the oral CGRPs that are still outstanding, and probably first, I would go to safety.

我認為有幾個關於口頭 CGRP 的問題仍然很突出，可能首先，我會去安全的地方。

One of the great things I think about the drugs like Emgality is the great safety data that we've been able to generate here.

我認為像 Emgality 這樣的藥物的一大優點是我們已經能夠在這裡生成出色的安全數據。

Remember, this is a relatively young and otherwise healthy population with a somewhat chronic disease.

請記住，這是一個相對年輕且健康的人群，患有某種慢性疾病。

And so safety's got to be a key factor in choosing a medication in this population.

因此，在這一人群中選擇藥物時，安全性必須是一個關鍵因素。

There are questions about the safety of the oral class, and we'll just have to see how that ends up with regulators.

關於口語課的安全性存在問題，我們只需要看看監管機構會如何處理。

I think there's also a bit of a mechanistic question here, which there's just not data to address yet.

我認為這裡還有一個機械問題，只是還沒有數據可以解決。

So the question, though, is if you've got chronic blockade of CGRP because patients are on a preventive antibody already, and we know we pretty much maxed out on the dose-response curve here, the question is whether adding an additional oral agent will have any effect if it'll even work as an abortive and people are already on chronic treatment.

所以問題是，如果你已經慢性阻斷 CGRP，因為患者已經在使用預防性抗體，而且我們知道我們在這裡的劑量反應曲線已經達到極限，問題是是否添加額外的口服藥物如果它甚至可以像流產一樣起作用並且人們已經在接受慢性治療，那麼它會產生任何影響。

So for that reason, we've looked for other mechanisms for migraine abortive that won't clash with CGRP antibodies but rather are likely to be complementary.

因此，出於這個原因，我們一直在尋找不會與 CGRP 抗體衝突但可能是互補的偏頭痛流產的其他機制。

So we're excited about the potential that we can offer with lasmiditan.

因此，我們對 lasmiditan 的潛力感到興奮。

And that's currently under FDA review and, I think, will be an important new treatment in the abortive space coming soon.

這目前正在接受 FDA 的審查，我認為，這將是即將到來的流產領域的一種重要的新療法。

Thanks, Dan.

謝謝，丹。

Louise, thanks for your question.

路易絲，謝謝你的提問。

We will go to the line of Jason Gerberry with Bank of America.

我們將與美國銀行一起前往 Jason Gerberry。

Just 2 questions from me.

我只有2個問題。

First, on tirzepatide, just thinking about absent the reporting of Phase 3 data, do you think we'll learn anything in the next 12 to 18 months as it pertains to the diarrhea side effects and whether it's a GIP-driven side effect.

首先，關於 tirzepatide，僅考慮缺少第 3 階段數據的報告，您認為我們會在接下來的 12 到 18 個月內學到什麼，因為它與腹瀉副作用以及它是否是 GIP 驅動的副作用有關。

And then my second question.

然後我的第二個問題。

Just on the Olumiant detailed Phase III BREEZE data in atopic dermatitis, the IgA scores relative to dupilumab were a bit lower.

就在特應性皮炎中 Olumiant 詳細的 III 期 BREEZE 數據中，IgA 評分相對於 dupilumab 略低。

So just sort of curious based on the data we have so far on hand, how do you think Olumiant could be positioned in the atopic dermatitis market?

因此，根據我們目前掌握的數據，有點好奇，您認為 Olumiant 如何在特應性皮炎市場定位？

Okay.

好的。

Thanks.

謝謝。

Enrique for tirzepatide then we'll go to Dan for the Olumiant question.

Enrique 的 tirzepatide 然後我們會去找 Dan 的 Olumiant 問題。

Yes.

是的。

My sense is I'm sure that we're going to be waiting for the Phase III trials and we will see basically some of the Phase III trials for us to understand what this dose titration actually delivers when it comes to tolerability.

我的感覺是，我確信我們將等待 III 期試驗，我們將基本上看到一些 III 期試驗，以便我們了解這種劑量滴定在耐受性方面的實際效果。

And as we mentioned, we feel very comfortable given the modeling, given the studies that we've done, that we are going to have a product that has unsurpassed efficacy, resetting expectations for A1c and weight loss and, at the same time, a product that is tolerable and comparable to GLP-1s.

正如我們所提到的，考慮到模型，鑑於我們已經完成的研究，我們感到非常舒服，我們將擁有一種具有無與倫比功效的產品，重新設定對 A1c 和減肥的期望，同時，可耐受且可與 GLP-1 相媲美的產品。

Thanks, Enrique.

謝謝，恩里克。

Dan?

擔？

Yes.

是的。

Thanks for the question on Olumiant for atopic derm.

感謝您對 Oluminant 的特應性皮膚問題。

You're specifically comparing it to dupilumab.

您專門將其與 dupilumab 進行比較。

I'd just point out obviously that it's tough to compare, in this case, an oral medication with injectable biologic for atopic derm.

我只是明確指出，在這種情況下，很難比較一種口服藥物與可注射生物製劑治療特應性皮膚。

I think Olumiant has some advantages in the rapidity of action, and patients may like that.

我認為 Olumiant 在起效快方面有一些優勢，患者可能會喜歡。

But really, I think the important comparison here is versus other orals for atopic derm, and there are none yet.

但實際上，我認為這裡的重要比較是與其他口腔異位性皮膚的比較，目前還沒有。

So we have the potential to be the first oral for atopic derm, and I think that's encouraging.

所以我們有潛力成為第一個針對特應性皮膚的口服藥物，我認為這令人鼓舞。

We've got more data to come here, and we'll see how that comes out.

我們有更多的數據要來這裡，我們會看看結果如何。

Thanks, Dan.

謝謝，丹。

Jason, thanks for your questions.

傑森，謝謝你的提問。

We will go to the line of Navin Jacob with UBS.

我們將與 UBS 一起前往 Navin Jacob 的路線。

Just on Taltz, wondering if you could give any color on the underlying volume growth of the overall psoriasis market and psoriatic arthritis market.

就在 Taltz 上，想知道您是否可以對整個銀屑病市場和銀屑病關節炎市場的潛在銷量增長給出任何顏色。

Abbvie is pointing to double-digit underlying market growth in terms of a dynamic that perhaps some of us are missing.

艾伯維（Abbvie）指出潛在市場的兩位數增長是我們中一些人可能缺少的動態。

I'm just wondering if you're seeing that level of growth.

我只是想知道你是否看到了這種增長水平。

And then with regards to your SG&A line, you came in a little bit higher than expectations, raised your guidance for the year.

然後關於您的 SG&A 線，您的收入略高於預期，提高了您對今年的指導。

Over the next couple of years, I know you're launching a bunch of products.

在接下來的幾年裡，我知道你們會推出很多產品。

Wondering how you're thinking about that line, how we should be thinking about it.

想知道你是如何考慮這條線的，我們應該如何考慮它。

And then finally, with regards to your capital allocation, we've seen several companies in this space do large deals and/or just yesterday a large spin-off.

最後，關於您的資本分配，我們已經看到該領域的幾家公司進行了大宗交易和/或就在昨天進行了大規模分拆。

Any color on how you're thinking about your business, whether there's any potential for restructuring that we may not be necessarily thinking about and/or your continued interest in bolt-on M&A deals?

關於您如何看待您的業務的任何顏色，是否存在我們可能不一定會考慮的重組潛力和/或您對補強併購交易的持續興趣？

Okay.

好的。

Thanks.

謝謝。

So we'll go to Josh for the Taltz and SG&A questions and Dave talking about the capital allocation structuring.

因此，我們將向 Josh 詢問 Taltz 和 SG&A 問題，以及 Dave 談論資本分配結構。

Okay.

好的。

Great.

偉大的。

So first, on the overall derm market, we're seeing low double-digit growth in total across the class.

因此，首先，在整個真皮市場上，我們看到整個班級的總體增長率都保持在兩位數的低水平。

The IL-17s are, of course, growing faster than that, and I think we'd expect to continue to see, with the launch of SKYRIZI, the IL-23s grow.

當然，IL-17 的增長速度比這更快，我認為隨著 SKYRIZI 的推出，我們希望繼續看到 IL-23 的增長。

And again, I think that's what's probably most important is moving -- as I mentioned earlier, moving patients from TNFs to the modern 17s and 23s.

再一次，我認為這可能是最重要的移動——正如我之前提到的，將患者從 TNF 轉移到現代 17 歲和 23 歲。

So we're looking forward to the data that we'll generate later this year on our head-to-head versus Tremfya.

因此，我們期待今年晚些時候在我們與 Tremfya 的正面交鋒中產生的數據。

And again, we've focused on Taltz in psoriasis as on 100% clearance and acting fast and being durable.

再一次，我們專注於 Taltz 治療牛皮癬，因為它具有 100% 的清除率、快速的作用和耐用性。

So we're looking forward to continued growth in that market.

因此，我們期待該市場的持續增長。

If we move to SG&A, our guidance for the second half of the year really implies a pretty flat absolute level of SG&A with the first half of this year.

如果我們轉向 SG&A，我們對下半年的指導確實意味著 SG&A 的絕對水平與今年上半年相當。

We're comfortable with that.

我們對此感到滿意。

As you look, with our new product launches, we've got a lot of variable SG&A expense.

如您所見，隨著我們新產品的推出，我們有很多可變的 SG&A 費用。

We do a lot of direct-to-consumer advertising in the U.S., both television as well as digital.

我們在美國做了很多直接面向消費者的廣告，包括電視和數字廣告。

So we've got a good handle on how we pulse that investment.

所以我們已經很好地掌握了我們如何推動這項投資。

And we've -- clearly, in the second half of last year, as our new launches were scaling, we were putting a lot of money behind them.

而且我們 - 很明顯，在去年下半年，隨著我們新推出的產品規模不斷擴大，我們投入了大量資金。

We've continued that the first half of this year.

今年上半年我們一直在繼續。

But on an absolute basis, we feel comfortable with the sort of flat to moderate growth in SG&A as we look out over the course of the next few years.

但在絕對基礎上，我們對 SG&A 的平穩至適度增長感到滿意，因為我們展望了未來幾年的進程。

We think we're well invested behind our new launched products.

我們認為我們對新推出的產品進行了很好的投資。

And mostly, we'll see a mix of tactics but a pretty good absolute envelope where we are now.

大多數情況下，我們會看到各種戰術，但絕對是我們現在所處的一個非常好的絕對范圍。

And again, that reinforces, as I talked in the prepared remarks, as we look at operating margin for 2020 with the kind of sales growth that we'd expect headed into 2020, we do expect to see good operating leverage there and are very confident with our 31% operating margin target for 2020.

再一次，正如我在準備好的評論中所說，當我們著眼於 2020 年的營業利潤率以及我們預計到 2020 年的那種銷售增長時，我們確實希望在那裡看到良好的經營槓桿，並且非常有信心我們的 2020 年營業利潤率目標為 31%。

Thanks, Josh.

謝謝，喬希。

Dave?

戴夫？

Yes.

是的。

I mean on capital allocation, nothing changes for us.

我的意思是在資本配置方面，我們沒有任何改變。

I think we've said for quite some time, we don't believe in large-scale merger activity to generate value for shareholders.

我想我們已經說過很長時間了，我們不相信大規模的合併活動可以為股東創造價值。

We still don't believe that.

我們仍然不相信。

In terms of spinouts, yesterday's news, we don't have such an entity to spin out.

在分拆方面，昨天的新聞，我們沒有這樣的實體可以分拆。

We had one in animal health, and we executed that transaction.

我們在動物健康方面有一個，我們執行了那筆交易。

I guess the thinking being similar in that we think human innovative pharmaceuticals is the business to be and it's what we do well and where we can generate a lot of value for all stakeholders, patients, society and shareholders, if we execute.

我想這種想法是相似的，因為我們認為人類創新藥物是一項業務，這是我們做得好的地方，如果我們執行，我們可以為所有利益相關者、患者、社會和股東創造很多價值。

So our focus in terms of capital allocation is really on funding organic R&D and then looking outside for opportunities, bolt-ons mostly that would fall within the pipeline, building-type exercise where we can add value where it fits within our therapeutic focus and where we see value for us, shareholders and patients.

因此，我們在資本配置方面的重點實際上是為有機研發提供資金，然後在外部尋找機會，主要是在管道內進行補充，建立類型的練習，我們可以在適合我們治療重點的地方增加價值，在哪裡我們看到了對我們、股東和患者的價值。

So that's what we've been focused on for some time.

這就是我們一段時間以來一直關注的問題。

We had the Centrexion deal announced this quarter, Loxo in Q1.

我們在本季度宣布了與 Centrexion 的交易，即第一季度的 Loxo。

Those types of things are what we're interested in and where our focus lies.

這些類型的事情是我們感興趣的，也是我們關注的重點所在。

And I don't see there's a change from even the past 10 years.

而且我看不到與過去 10 年相比有什麼變化。

So we'll continue on that path.

所以我們將繼續走這條路。

Thanks, Dave.

謝謝，戴夫。

Navin, thanks for your questions.

納文，謝謝你的提問。

This ends the Q&A portion.

問答部分到此結束。

I'll turn it over to Dave for the close.

我將把它交給戴夫完成。

Great.

偉大的。

Thank you.

謝謝你。

We appreciate your participation in the call today and your interest in Eli Lilly and Company.

感謝您參加今天的電話會議以及您對禮來公司的興趣。

As we begin the second half of the year, we reflect on the meaningful progress we made in the first 2 quarters and the opportunity that lies ahead on the balance of 2019.

在下半年開始之際，我們回顧了前兩個季度取得的有意義的進展以及 2019 年餘下的機遇。

We are committed to our revenue and operating margin goals in 2019 and 2020 where we continue to invest in our innovation-based strategy.

我們致力於實現 2019 年和 2020 年的收入和營業利潤率目標，並繼續投資於我們的創新戰略。

With a pipeline full of exciting opportunities and a diversified, volume-driven growth in the market, Lilly continues to be a compelling investment.

憑藉充滿激動人心的機會和多元化、數量驅動的市場增長，禮來公司繼續成為一項引人注目的投資。

Thanks for dialing in.

感謝您撥入。

Please following up with our IR team if you have follow-up questions that we didn't address on today's call.

如果您有我們在今天的電話會議中沒有解決的後續問題，請與我們的 IR 團隊聯繫。

Hope everyone has a great day.

希望每個人都有美好的一天。

Thank you.

謝謝你。

And ladies and gentlemen, today's conference call will be available for replay after 11:15 a.m.

女士們先生們，今天的電話會議將在上午 11:15 後重播。

today until midnight, July 30, 2020.

即日起至 2020 年 7 月 30 日午夜。

You may access the AT&T TeleConference replay system by dialing (800) 475-6701 and entering the access code of 469634.

您可以通過撥打 (800) 475-6701 並輸入訪問代碼 469634 訪問 AT&T 電話會議重播系統。

International participants may dial (320) 365-3844.

國際參與者可撥打 (320) 365-3844。

That does conclude your conference call for today.

這確實結束了你今天的電話會議。

Thank you for your participation and for using the AT&T Executive TeleConference Service.

感謝您的參與和使用 AT&T 高管電話會議服務。

You may now disconnect.

您現在可以斷開連接。