禮來公司 (LLY) 2018 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Eli Lilly Fourth Quarter 2018 Earnings Call.

女士們，先生們，感謝您的支持，歡迎參加禮來公司 2018 年第四季度財報電話會議。

(Operator Instructions) As a reminder, today's call is being recorded.

（操作員說明）作為提醒，今天的通話正在錄音中。

I'll turn the conference now to Mr. Kevin Hern, Vice President of Investor Relations.

我現在將會議轉給投資者關係副總裁 Kevin Hern 先生。

Please go ahead, sir.

請繼續，先生。

Good morning.

早上好。

Thank you for joining us for Eli Lilly and Company's Q4 2018 earnings call.

感謝您參加禮來公司 2018 年第四季度財報電話會議。

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

我是投資者關係副總裁 Kevin Hern。

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

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

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

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

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

在這次電話會議期間，我們預計會根據我們目前的預期做出預測和前瞻性陳述。

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

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

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

我們提供的有關我們的產品和管道的信息是為了投資界的利益。

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

它不是為了促銷，也不足以做出處方決定。

I will now turn the call over to Dave for a summary of our progress in Q4.

我現在將把電話轉給 Dave，以總結我們在第四季度的進展。

Thanks, Kevin.

謝謝，凱文。

We continued our strong performance in 2018 with a fourth quarter revenue growth of 5%, non-GAAP operating income growth of 15% and non-GAAP EPS growth of 17%.

我們在 2018 年繼續保持強勁表現，第四季度收入增長 5%，非美國通用會計準則營業收入增長 15%，非美國通用會計準則每股收益增長 17%。

Newer pharmaceutical products, which represented 38% of human pharma revenue in the quarter, continue to be the driver of our worldwide revenue growth led by Trulicity, Taltz, Basaglar, Verzenio and Jardiance.

較新的醫藥產品在本季度佔人類醫藥收入的 38%，繼續成為我們全球收入增長的驅動力，由 Trulicity、Taltz、Basaglar、Verzenio 和 Jardiance 引領。

Highlights of our strong volume-based growth include 31% U.S. diabetes volume growth and 11% total pharma volume growth.

我們基於銷量的強勁增長的亮點包括美國糖尿病銷量增長 31% 和醫藥總銷量增長 11%。

This was achieved despite the significant headwind from the loss of exclusivity of Cialis in the U.S.

儘管 Cialis 在美國失去了排他性帶來了巨大的阻力，但還是實現了這一目標。

We continue to see our year-over-year expansion in operating margins.

我們繼續看到我們的營業利潤率同比增長。

Excluding the effect of FX on international inventories sold, Q4 non-GAAP operating income as a percent of revenue increased by over 165 basis points while investing in new product launches.

排除外匯對已售國際庫存的影響，第四季度非公認會計準則營業收入佔收入的百分比增加了 165 個基點以上，同時投資於新產品發布。

We made significant progress with the pipeline, including the approval of Emgality for the prophylaxis of migraine in Europe; the submission of Emgality for the prevention of -- and treatment of cluster headache in the U.S.; results from a Phase III study of tanezumab in patients with moderate to severe osteoarthritis pain and the results of 2 Phase III studies of baricitinib in atopic dermatitis.

我們在管道方面取得了重大進展，包括批准 Emgality 在歐洲預防偏頭痛；在美國提交用於預防和治療叢集性頭痛的 Emgality；來自 tanezumab 在中度至重度骨關節炎疼痛患者中的 III 期研究結果和 baricitinib 在特應性皮炎中的 2 項 III 期研究結果。

We also provided an update and announced the confirmatory Phase III study of Lartruvo in combination with doxorubicin for advanced or metastatic soft tissue sarcoma.

我們還提供了更新並宣布了 Lartruvo 與多柔比星聯合用於晚期或轉移性軟組織肉瘤的驗證性 III 期研究。

This study did not meet the primary endpoint of overall survival, and there was no difference in survival between the study arms.

該研究未達到總生存期的主要終點，研究組之間的生存期沒有差異。

We are now working with global regulators to determine the next steps for Lartruvo, and we'll present the announced data at an upcoming medical conference.

我們現在正在與全球監管機構合作，以確定 Lartruvo 的下一步，我們將在即將召開的醫學會議上公佈公佈的數據。

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

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

We announced a definitive agreement to acquire Loxo Oncology, a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers, which would add multiple first-in-class medicines to the Lilly portfolio and expand our oncology presence into precision medicines.

我們宣布了收購 Loxo Oncology 的最終協議，Loxo Oncology 是一家專注於為基因組定義的癌症患者開發和商業化高選擇性藥物的生物製藥公司，這將為禮來產品組合增加多種一流的藥物，並將我們的腫瘤學業務擴展到精準藥物。

We also announced several other business development transactions, including an agreement with AC Immune to develop small molecule tau inhibitors for Alzheimer's and other neurodegenerative diseases.

我們還宣布了其他幾項業務開發交易，包括與 AC Immune 達成協議，開髮用於阿爾茨海默氏症和其他神經退行性疾病的小分子 tau 抑製劑。

We announced an agreement with Hydra Biosciences to acquire all assets related to their preclinical TRPA1 antagonist program, currently being studied for the treatment of chronic pain, and an agreement with Aduro Biotech to develop novel immunotherapies for autoimmune and other inflammatory diseases.

我們宣布與 Hydra Biosciences 達成協議，收購與其臨床前 TRPA1拮抗劑項目相關的所有資產，目前正在研究用於治療慢性疼痛，並與 Aduro Biotech 達成協議，開發針對自身免疫和其他炎症性疾病的新型免疫療法。

In addition, we returned over $600 million via the dividend and announced a 15% dividend increase for 2019.

此外，我們通過股息返還了超過 6 億美元，並宣布 2019 年股息增加 15%。

We also repurchased $1.1 billion of stock.

我們還回購了 11 億美元的股票。

I'd also like to provide an update on our plans for completing the full separation of Elanco.

我還想提供有關我們完成 Elanco 完全分離的計劃的最新信息。

As we stated during our December investment community meeting, operationally, we are ready to effect the full separation.

正如我們在 12 月的投資界會議上所說，在運營上，我們已準備好實現全面分離。

Today, we are providing a time line for the separation as well as the method we'll use to dispose our remaining 293 million Elanco shares.

今天，我們提供了分離的時間表以及我們將用來處置我們剩餘的 2.93 億股 Elanco 股票的方法。

Specifically, we plan to launch an exchange offer to Lilly's shareholders in the first half of this year to exchange our remaining Elanco shares for Lilly shares.

具體來說，我們計劃在今年上半年向禮來的股東發起換股要約，將我們剩餘的 Elanco 股票換成禮來股票。

The exact timing of the decision to launch this exchange offer will depend on market conditions.

決定啟動此交換要約的確切時間將取決於市場情況。

But the launch of a tender could occur as early as the coming days.

但最早可能會在未來幾天啟動招標。

We're pleased with the market reception of the Elanco IPO and with Elanco's performance as a publicly traded company.

我們對 Elanco IPO 的市場接受度以及 Elanco 作為上市公司的表現感到滿意。

Jeff and his team are well prepared to take the next step, and Elanco employees are excited about their future.

Jeff 和他的團隊已經做好了下一步的準備，Elanco 的員工對他們的未來感到興奮。

We're proud of what we've accomplished together and we share their enthusiasm for Elanco's future.

我們為我們共同取得的成就感到自豪，我們分享他們對 Elanco 未來的熱情。

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

轉到幻燈片 5 和 6，您將看到有關自 11 月財報電話會議以來關鍵事件的更多詳細信息。

Now I'll turn the call over to Josh to review the Q4 results and to provide an update on our financial guidance for 2019.

現在，我將把電話轉給喬什，以審查第四季度的業績，並提供我們 2019 年財務指導的最新信息。

Thanks, Dave.

謝謝，戴夫。

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

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

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

我將把我的評論集中在我們的非公認會計原則調整措施上，以深入了解我們業務的潛在趨勢，因此請參閱今天的收益新聞稿，詳細描述我們第四季度公認會計原則結果的同比變化.

So looking at non-GAAP measures on Slide 9, you'll see the revenue increase of 5% that Dave mentioned earlier.

因此，查看幻燈片 9 上的非 GAAP 指標，您會看到 Dave 之前提到的 5% 的收入增長。

Gross margin as a percent of revenue increased 50 basis points to 76.6%.

毛利率佔收入的百分比增加了 50 個基點，達到 76.6%。

Excluding the effect of foreign exchange rates on international inventories sold, gross margin as a percent of revenue declined about 25 basis points.

排除匯率對國際銷售庫存的影響，毛利率佔收入的百分比下降了約 25 個基點。

Total operating expense increased 1%, with marketing, selling and administrative expense increasing 3%, driven primarily by increased expenses to support our newer product launches, including the U.S. launch of Emgality, while R&D expense declined 2%.

總運營費用增長 1%，營銷、銷售和管理費用增長 3%，主要是由於支持我們新產品發布的費用增加，包括在美國推出 Emgality，而研發費用下降了 2%。

Total operating expense as a percent of revenue compared to Q4 2017 declined by over 190 basis points, benefiting from previously announced actions taken to reduce the company's cost structure, partially offset by investments in new launches in our newest late-phase pipeline entries.

與 2017 年第四季度相比，總運營費用佔收入的百分比下降了 190 多個基點，這得益於先前宣布的為降低公司成本結構而採取的行動，部分被我們最新的後期管道條目中的新產品投資所抵消。

Operating income increased 15% compared to Q4 2017, which put our operating margin at 25.1% for the quarter.

與 2017 年第四季度相比，營業收入增長了 15%，這使我們本季度的營業利潤率為 25.1%。

And our operating margin, excluding the effect of FX on international inventories sold was 24.8% of revenue, an improvement of over 165 basis points versus last year's quarter.

我們的營業利潤率（不包括外匯對已售國際庫存的影響）佔收入的 24.8%，與去年同期相比提高了 165 個基點以上。

Other income and expense was expense of $4.8 million for this quarter compared to income of $111.9 million in last year's quarter, driven by approximately $100 million less in gains on investments.

本季度的其他收入和支出為 480 萬美元，而去年同期的收入為 1.119 億美元，主要是由於投資收益減少了約 1 億美元。

This reduction was due primarily to a large gain on the sale of an equity investment in last year's quarter and to a lesser extent, mark-to-market reductions in strategic partnership or VC investments in public biotech companies in this year's quarter.

這一減少主要是由於去年季度出售股權投資的巨大收益，以及在較小程度上減少了今年季度對公共生物技術公司的戰略合作夥伴或風險投資的按市值計價的投資。

Our tax rate was 15.8%, a decrease of 440 basis points compared with the same quarter last year, driven primarily by the impact of U.S. tax reform.

我們的稅率為 15.8%，與去年同期相比下降了 440 個基點，主要受美國稅制改革的影響。

So the bottom line, net income increased 13%, while earnings per share increased faster at 17% due to a reduction in shares outstanding from share repurchases.

因此，最重要的是，淨收入增長了 13%，而每股收益增長更快，達到了 17%，原因是股票回購導致的流通股減少。

Earnings per share also included a reduction of approximately $0.02 per share to reflect the noncontrolling interest in Elanco.

每股收益還包括每股減少約 0.02 美元，以反映 Elanco 的非控制性權益。

Consistent with our performance throughout the year, we achieved significant earnings growth this quarter by delivering mid-single-digit revenue growth while carefully managing our operating expenses, leading to meaningful improvement in profitability versus last year.

與我們全年的業績一致，我們在本季度實現了顯著的盈利增長，實現了中個位數的收入增長，同時謹慎管理我們的運營費用，與去年相比，盈利能力顯著提高。

Slide 10 details these same non-GAAP measures for the full year, where you can see the full year impact of our strong top line growth and margin expansion as revenue grew 7%, while operating expenses declined by 1%, which led to a 30% growth in non-GAAP EPS.

幻燈片 10 詳細介紹了這些相同的全年非 GAAP 指標，您可以在其中看到我們強勁的收入增長和利潤率擴張對全年的影響，因為收入增長了 7%，而運營費用下降了 1%，這導致了 30非公認會計原則每股收益增長百分比。

Excluding the impact of FX on inventories sold, operating income as a percent of revenue for the full year was 28.4%, an increase of 470 basis points compared to 2017.

剔除外匯對已售存貨的影響，全年營業收入佔收入的百分比為 28.4%，比 2017 年增加 470 個基點。

Moving to Slide 11 provides a reconciliation between reported and non-GAAP EPS, and you'll find additional details on these adjustments on Slides 25 and 26.

移至幻燈片 11 提供了報告和非公認會計原則每股收益之間的對賬，您將在幻燈片 25 和 26 上找到有關這些調整的更多詳細信息。

Moving to Slide 12.

轉到幻燈片 12。

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

讓我們看看價格、費率和數量對收入增長的影響。

This quarter, foreign exchange reduced growth by 1 percentage point.

本季度，外匯增速下降1個百分點。

On a performance basis, worldwide revenue grew 6%, driven by an 11% increase in volume, partially offset by price.

在業績的基礎上，全球收入增長了 6%，這主要得益於銷量增長 11%，但部分被價格抵消了。

Q4 represented the second straight quarter our human pharma business delivered double-digit volume growth.

第四季度是我們的人類製藥業務連續第二個季度實現兩位數的銷量增長。

U.S. pharma revenue increased 6%.

美國製藥收入增長 6%。

Like last quarter, strong volume growth, which was 12%, led by Trulicity, Taltz, Basaglar and Verzenio, was partially offset by price.

與上一季度一樣，由 Trulicity、Taltz、Basaglar 和 Verzenio 引領的 12% 的強勁銷量增長被價格部分抵消。

Excluding Cialis, volume grew nearly 20% -- 21% in the U.S., highlighted by U.S. diabetes products delivering over 31% volume growth.

不包括 Cialis，銷量增長近 20%——美國的銷量增長了 21%，其中美國糖尿病產品銷量增長超過 31% 尤為突出。

While the U.S. pricing environment continues to evolve, our sustained success is driven by the execution of our volume-based growth strategy.

雖然美國的定價環境在不斷發展，但我們的持續成功是由我們基於數量的增長戰略的執行推動的。

U.S. price declined 6%, which was similar to Q3.

美國價格下跌 6%，與第三季度相似。

Approximately 3 points of the U.S. price decline was driven by changes to estimates of rebates and discounts and disproportionate volume growth in certain government segments for Trulicity.

大約 3 個百分點的美國價格下跌是由於對 Trulicity 某些政府部門的回扣和折扣估計的變化以及不成比例的銷量增長造成的。

Roughly 1 point of the decline was driven by new access and corresponding volume for Basaglar in Medicare Part D, which we didn't have in last year's quarter.

大約 1 個百分點的下降是由醫療保險 D 部分中 Basaglar 的新准入和相應數量推動的，我們在去年的季度沒有。

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

我們也有大約 2 個下降點，這與 Taltz 和 Humalog 的患者負擔能力和訪問計劃的增加有關，這也推動了數量的增加。

Looking forward to 2019, we remain comfortable with our projection of mid-single-digit declines in U.S. price, more than offset by increased volumes.

展望 2019 年，我們仍然對美國價格中個位數下降的預測感到滿意，但被銷量增加所抵消。

Moving to Europe.

搬到歐洲。

Pharma revenue grew 3%, driven by volume, largely offset by the negative effect of price and foreign exchange.

在銷量的推動下，醫藥收入增長了 3%，但很大程度上被價格和外彙的負面影響所抵消。

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

儘管失去了 Cialis 的排他性，但還是實現了這一銷量增長。

Excluding Cialis, volume grew over 16%.

不包括 Cialis，銷量增長超過 16%。

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

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

In Japan, pharma revenue was up 1% with 9% volume growth, largely offset by a drag of 8% from the impact of the biannual pricing cuts which took effect in Q1.

在日本，製藥收入增長 1%，銷量增長 9%，很大程度上被第一季度生效的半年度降價帶來的 8% 拖累所抵消。

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

銷量增長是由以 Trulicity、Jardiance 和 Olumiant 為首的新產品推動的，Cymbalta 也做出了重大貢獻。

Our pharma revenue in the rest of the world increased 10% on a performance basis this quarter, led by volume growth from our diabetes portfolio, namely Humalog, Trulicity and Jardiance, in collaboration with Boehringer Ingelheim.

本季度我們在世界其他地區的製藥收入增長了 10%，這主要得益於我們與勃林格殷格翰合作的糖尿病產品組合（即 Humalog、Trulicity 和 Jardiance）的銷量增長。

Turning to animal health.

轉向動物健康。

Worldwide revenue grew 6% on a performance basis this quarter, driven by higher volume, higher sales of companion animal disease prevention and future protein and health products was partially offset by lower sales of products that are being exited, and to a lesser extent, declines in products for ruminants and swine and companion animal therapeutics.

本季度全球收入在業績基礎上增長了 6%，這是由於銷量增加、伴侶動物疾病預防和未來蛋白質和健康產品的銷售額增加，部分被正在退出的產品銷售額下降所抵消，並且在較小程度上下降了用於反芻動物、豬和伴侶動物治療的產品。

Slide 13 outlines the same information for our full year results.

幻燈片 13 概述了我們全年業績的相同信息。

Now let's take a look at the drivers of our 11% worldwide volume growth on Slide 14.

現在讓我們在幻燈片 14 上看一下我們 11% 的全球銷量增長的驅動因素。

Once again, our newer products were the engine of our worldwide volume growth.

我們的新產品再次成為我們全球銷量增長的引擎。

These products drove 13.7 percentage points of volume growth this quarter, nearly identical to their contribution in Q3.

這些產品在本季度推動了 13.7 個百分點的銷量增長，幾乎與它們在第三季度的貢獻相同。

Brands that have experienced loss of exclusivity provided a drag of 450 basis points, driven almost entirely by Cialis.

失去排他性的品牌拖累了 450 個基點，幾乎完全由 Cialis 推動。

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

您可能還記得去年 9 月底 Cialis 的仿製藥進入美國市場，正如預期的那樣，我們已經看到銷售迅速下降。

When excluding LOEs, the rest of our products posted Q4 volume growth of over 18%.

排除 LOE 後，我們的其他產品第四季度銷量增長超過 18%。

Slide 15 provides a view of our newer product uptake.

幻燈片 15 提供了我們新產品吸收的視圖。

In total, these brands generated over $2.1 billion in revenue this quarter, representing 38% of our human pharmaceutical revenue.

這些品牌本季度的總收入超過 21 億美元，占我們人用藥物收入的 38%。

Our newer product growth demonstrates the successful execution of our commercial strategy.

我們新產品的增長證明了我們商業戰略的成功執行。

We're particularly excited about the launch of Emgality in the U.S. for the preventative treatment of migraine.

我們對在美國推出用於預防偏頭痛的 Emgality 感到特別興奮。

While still early, the NBRx share gains we've experienced to date have been impressive.

雖然仍處於早期階段，但我們迄今為止所經歷的 NBRx 份額增長令人印象深刻。

Combined with best-in-class U.S. payer access, we anticipate Emgality will be a meaningful growth driver going forward, demonstrating the promising future for our pain franchise.

結合一流的美國付款人准入，我們預計 Emgality 將成為未來有意義的增長驅動力，展示我們疼痛特許經營的美好未來。

Moving to Slide 16.

轉到幻燈片 16。

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

繼續我們的非公認會計原則解釋，本季度，外匯對我們的損益表的影響相對較小，對收入的負面影響較小，對營業收入和每股收益的影響較小。

Turning to our 2019 financial guidance on Slide 17, you will see that we've updated our non-GAAP guidance to reflect an approximate $0.34 impact of the anticipated Loxo Oncology acquisition, which we assume closes this quarter.

轉向我們在幻燈片 17 上的 2019 年財務指導，您會看到我們已經更新了我們的非公認會計準則指導，以反映預期的 Loxo Oncology 收購的大約 0.34 美元的影響，我們假設本季度結束。

Additionally, the approximately $0.17 negative impact of Lartruvo's Phase III ANNOUNCE study results was offset by positive trends in our core performance business performance and improved tax rate versus what we projected in December.

此外，Lartruvo 的 III 期 ANNOUNCE 研究結果帶來的大約 0.17 美元的負面影響被我們的核心業績業務表現的積極趨勢和與我們在 12 月預測的稅率相比有所提高所抵消。

This updated non-GAAP guidance by line item includes a decrease of $200 million on the top line, driven by the impact of Lartruvo, partially offset by the inclusion of Vitrakvi and an improvement sales outlook across other products based on Q4 momentum; an increase of $200 million for R&D expense due to the addition of the Loxo Oncology pipeline; and a decrease of $100 million for other income and expense to a range of between $175 million and $325 million of expense, which is driven by higher net interest expense due to the Loxo Oncology acquisition.

此更新後的非公認會計原則（non-GAAP）指引包括受 Lartruvo 影響的推動，收入減少了 2 億美元，部分被 Vitrakvi 的加入以及基於第四季度勢頭的其他產品的銷售前景改善所抵消；由於增加了 Loxo Oncology 管道，研發費用增加了 2 億美元；其他收入和支出減少 1 億美元至 1.75 億美元至 3.25 億美元之間，這是由於收購 Loxo Oncology 導致淨利息支出增加所致。

As we stated during our investor call for the acquisition, the incremental interest expense reflects only a portion of the financing as our 2019 guidance in December had already contemplated business development financing needs for roughly half the size of the transaction.

正如我們在投資者呼籲收購時所說，增量利息費用僅反映了融資的一部分，因為我們在 12 月的 2019 年指導已經考慮了大約一半交易規模的業務發展融資需求。

A decrease in our effective tax rate from 16% to 15% driven by adjustments for U.S. tax reform, and this results in a decrease on our non-GAAP earnings per share range to $5.55 per share to $5.65 per share.

由於美國稅制改革的調整，我們的有效稅率從 16% 降至 15%，這導致我們的非公認會計準則每股收益範圍降至每股 5.55 美元至每股 5.65 美元。

I would note that the revised guidance continues to include a reduction of approximately $0.08 per share to reflect the noncontrolling interest portion of Elanco profits for full year.

我會注意到，修訂後的指引繼續包括每股減少約 0.08 美元，以反映 Elanco 全年利潤的非控制性權益部分。

The average of the 2019 non-GAAP earnings per share estimates for analysts who have updated their model since the Loxo Oncology and Lartruvo announcement is $5.55.

自 Loxo Oncology 和 Lartruvo 公告以來，已更新其模型的分析師的 2019 年非公認會計原則每股收益估計平均值為 5.55 美元。

And for those who haven't updated since our December meeting, the average estimates for those is $5.94.

對於那些自我們 12 月會議以來還沒有更新的人，他們的平均估計是 5.94 美元。

Touching briefly on our updated GAAP guidance.

簡要介紹我們更新的 GAAP 指南。

The 50 basis point increase in the effective tax rate is due to certain Loxo Oncology acquisition and integration expenses not being deductible for tax purposes.

有效稅率提高 50 個基點是由於某些 Loxo Oncology 收購和整合費用不能用於稅收目的。

In addition, GAAP earnings per share for 2019 is now expected to be in the range of $4.57 per share to $4.67 per share.

此外，現在預計 2019 年的 GAAP 每股收益將在每股 4.57 美元至 4.67 美元之間。

I'd note that currently, the euro is slightly weaker and the yen and renminbi are slightly stronger than what we assumed in our guidance in December, but in total, FX impacts are modest.

我要注意的是，目前歐元略弱，日元和人民幣略強於我們在 12 月指引中的假設，但總體而言，外匯影響是溫和的。

We'll monitor FX movements and incorporate changes as appropriate in our quarterly updates.

我們將監控外匯走勢並在我們的季度更新中酌情合併變化。

Moving to Slide 18.

轉到幻燈片 18。

The numbers here should be helpful as you think about our business on a go-forward basis, post the separation of Elanco.

當您在 Elanco 分離後考慮我們的業務時，這裡的數字應該會有所幫助。

Our pharma-only expectations for 2019 first shared with you at our December investment community reflect mid-single-digit revenue growth; relatively flat marketing, selling and administrative expenses; R&D growth to accommodate the Loxo Oncology acquisition and other Phase III investments; and operating income as a percent of revenue at approximately 28% or 27.5%, excluding the effect of FX on international inventories sold.

我們在 12 月的投資社區中首次與您分享了我們對 2019 年僅製藥業的預期，反映了中個位數的收入增長；相對平穩的營銷、銷售和管理費用；研發增長以適應 Loxo Oncology 收購和其他 III 期投資；營業收入佔收入的百分比約為 28% 或 27.5%，不包括外匯對已售國際庫存的影響。

We will provide an EPS range once we have executed the Elanco exchange offer and know the number of Lilly shares retired.

一旦我們執行了 Elanco 交換要約並知道了禮來公司的股票數量，我們將提供每股收益範圍。

Although our updated full company EPS guidance is lower than our December guidance due to the Loxo Oncology acquisition, we still expect strong full year performance, led by volume gains in our newer products.

儘管由於收購 Loxo Oncology，我們更新的全公司每股收益指引低於我們 12 月的指引，但我們仍然預計全年業績強勁，這主要得益於我們新產品的銷量增長。

We remain committed to our innovation-based strategy and are making substantial investments in 2019 to bring forward our next generation of new products.

我們將繼續致力於以創新為基礎的戰略，並在 2019 年進行大量投資，以推出我們的下一代新產品。

And I'd also note that despite the incremental costs associated with the Loxo Oncology pipeline and the unexpected Lartruvo impact, we are committed to and confident in achieving our 2020 sales and operating margin goals.

而且我還要指出，儘管與 Loxo Oncology 管道相關的增量成本和意想不到的 Lartruvo 影響，我們致力於並有信心實現我們的 2020 年銷售和營業利潤率目標。

As we move forward, we'll continue to prioritize funding for our existing marketed products, new launches and life cycle opportunities in addition to replenishing our pipeline.

隨著我們的前進，除了補充我們的管道外，我們將繼續優先為我們現有的已上市產品、新產品發布和生命週期機會提供資金。

We will also continue to leverage business development to upgrade our pipeline and future growth prospects.

我們還將繼續利用業務發展來升級我們的管道和未來的增長前景。

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

最後，我們將通過增加股息和股票回購將多餘的現金返還給股東。

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

現在，我將把電話轉回給 Dave，以審查管道和未來的關鍵事件。

Thanks, Josh.

謝謝，喬希。

Slide 19 shows select pipeline opportunities as of February 1. In addition to the pending addition of Loxo assets, movement since our last earnings calls include the U.S. submission of Emgality for episodic cluster headache; the start of Phase III for tirzepatide in type 2 diabetes; the start of Phase II for a once-weekly basal insulin and automated insulin delivery system, which is part of our connected care efforts that Dan highlighted at our December investment community meeting, and a new indication for Verzenio in prostate cancer; the initiation of Phase I testing for 8 biologic entities across our therapeutic areas; and the attrition of 3 early-stage molecules.

幻燈片 19 顯示了截至 2 月 1 日的選定管道機會。除了待添加的 Loxo 資產外，自我們上次財報電話會議以來的變動包括美國提交 Emgality 治療偶發性叢集性頭痛； tirzepatide 治療 2 型糖尿病的 III 期開始；每週一次的基礎胰島素和自動胰島素輸送系統的 II 期開始，這是 Dan 在 12 月投資社區會議上強調的我們互聯護理工作的一部分，以及 Verzenio 在前列腺癌中的新適應症；開始對我們治療領域的 8 個生物實體進行 I 期測試；以及 3 個早期分子的損耗。

On Slide 20, we provide a final tally on the key events we expected for 2018.

在幻燈片 20 中，我們提供了對 2018 年預期關鍵事件的最終統計。

As we reviewed in detail at our December investment community meeting, 2018 was a strong year for progress in our pipeline and in execution of our innovation-based strategy.

正如我們在 12 月的投資社區會議上詳細回顧的那樣，2018 年是我們在管道和執行基於創新的戰略方面取得進展的強勁一年。

And while we experienced a setback on Lartruvo in January, we entered 2019 with great momentum.

雖然我們在一月份在拉特魯沃遇到了挫折，但我們以強勁的勢頭進入了 2019 年。

Slide 21 shows the early progress we made on key events and we're monitoring for 2019.

幻燈片 21 顯示了我們在關鍵事件上取得的早期進展，我們正在監測 2019 年。

These include the initiation of a Phase III study of empagliflozin in chronic kidney disease; results from a Phase III study of tanezumab in osteoarthritis pain; results from 2 Phase III studies for baricitinib in atopic dermatitis; and the previously announced and discussed Lartruvo study.

其中包括啟動恩格列淨治療慢性腎病的 III 期研究；來自 tanezumab 治療骨關節炎疼痛的 III 期研究結果；巴瑞克替尼治療特應性皮炎的 2 項 III 期研究結果；以及之前宣布並討論過的拉特魯沃研究。

Now let me briefly sum up the progress we've made in the past 12 months and our priorities moving forward.

現在讓我簡要總結一下我們在過去 12 個月中取得的進展以及我們前進的重點。

In 2018, we delivered strong volume-based revenue growth of 7%, driven entirely by our new products, which accounted in the calendar year for 34% of pharma revenue.

2018 年，我們實現了 7% 的強勁收入增長，這完全是由我們的新產品推動的，新產品在該日曆年佔製藥收入的 34%。

We continued our strong operating performance and our margin expansion of over 470 basis points, including -- excluding the impact of foreign exchange on international inventories sold.

我們繼續保持強勁的經營業績和超過 470 個基點的利潤率擴張，包括 - 不包括外匯對已售國際庫存的影響。

We've seen excellent progress in our pipeline with our internal and external innovation investments yielding multiple approvals, submissions and positive Phase III readouts, along with several significant first-in-class additions to our late-stage pipeline.

我們已經看到我們的管道在我們的管道中取得了巨大進展，我們的內部和外部創新投資產生了多次批准、提交和積極的第三階段讀數，以及我們後期管道的幾個重要的一流添加。

We completed a review of the strategic alternatives for Elanco.

我們完成了對 Elanco 戰略備選方案的審查。

Through a well-received initial public offering, Elanco Animal Health became a publicly traded company.

通過廣受好評的首次公開募股，Elanco Animal Health 成為一家上市公司。

Elanco raised over $4 billion through the IPO and debt offering, the vast majority of which was provided to Lilly as consideration for the businesses Lilly transferred to Elanco in connection with the IPO.

Elanco 通過 IPO 和債券發行籌集了超過 40 億美元，其中絕大多數提供給禮來公司，作為禮來公司在 IPO 中轉讓給 Elanco 的業務的對價。

We also returned approximately $6.5 billion to shareholders via the dividend and share repurchase, announced the pending acquisition of Loxo Oncology and bolstered our early phase pipeline and preclinical platforms with numerous business development deals.

我們還通過股息和股票回購向股東返還了大約 65 億美元，宣布即將收購 Loxo Oncology，並通過眾多業務開發交易支持我們的早期管道和臨床前平台。

Moving into 2019, we remain focused on launching with excellence and continuing to replenish our pipeline.

進入 2019 年，我們將繼續專注於推出卓越產品並繼續補充我們的產品線。

Before moving to Q&A, I'd like to take a moment to comment on the latest news regarding potential U.S. health care system reform.

在進行問答之前，我想花點時間評論一下有關美國潛在的醫療保健系統改革的最新消息。

The proposed rule that would eliminate the safe harbor protections for rebates within the Medicare and managed Medicaid segments will represent meaningful change to the system.

提議的規則將消除醫療保險和管理的醫療補助部分內的回扣安全港保護，這將代表系統的有意義的變化。

While it's still a proposal, we see this as potentially accomplishing the following: first, this could be a win for patients, lowering their out-of-pocket costs at the pharmacy counter, with the greatest benefit realized by patients taking more highly rebated products such as insulin.

雖然這仍然是一個建議，但我們認為這可能會實現以下目標：首先，這可能是患者的勝利，降低了他們在藥房櫃檯的自付費用，最大的好處是患者服用了更高折扣的產品比如胰島素。

Second, for innovative products and companies, the rule will shift the focus to demonstrating the value of our medicines and partnering with health insurers and systems to improve quality, outcomes and lowering overall medical costs.

其次，對於創新產品和公司，該規則將把重點轉移到展示我們藥物的價值以及與健康保險公司和系統合作以提高質量、結果和降低整體醫療成本。

Patients should directly benefit from price reductions and concessions in federal and commercial plans.

患者應直接受益於聯邦和商業計劃的降價和讓步。

Unfortunately, as you know, this rarely occurs today.

不幸的是，如您所知，這種情況在今天很少發生。

Finally, this change could remove an artificial barrier to competition, creating space for innovation that addresses unmet needs for patients.

最後，這種變化可以消除競爭的人為障礙，為解決患者未滿足需求的創新創造空間。

We continue to support making medicines more affordable and accessible to patients.

我們繼續支持使患者更負擔得起和更容易獲得藥物。

Too often, the sick are subsidizing [the healthy] on our current system, and this appears to be a positive tool to address this issue.

很多時候，病人在我們當前的系統上補貼[健康]，這似乎是解決這個問題的積極工具。

We are for improvements to U.S. health care system like this, which appropriately balance patient affordability, market-based principles and reward innovation.

我們支持像這樣改進美國醫療保健系統，適當平衡患者的負擔能力、基於市場的原則和獎勵創新。

While I know you likely have many questions on this, I'm sure we'll continue to talk about this as more details emerge about the rule.

雖然我知道您可能對此有很多疑問，但我相信隨著有關該規則的更多細節出現，我們將繼續討論這個問題。

This concludes our prepared remarks.

我們準備好的評論到此結束。

And now I'd like to turn the call back over to Kevin to moderate the Q&A session.

現在我想把電話轉回給 Kevin 來主持問答環節。

Thanks, Dave.

謝謝，戴夫。

(Operator Instructions)

（操作員說明）

(Operator Instructions) First, we'll go to the line of Seamus Fernandez with Guggenheim.

（操作員說明）首先，我們將與古根海姆一起前往 Seamus Fernandez 的路線。

So just really quickly, 2 both on pipeline products.

所以很快，2 都在管道產品上。

Just -- can you guys give us a quick sense of the expectations for the -- how tanezumab, a REMS program might be implemented?

只是——你們能否讓我們快速了解一下對 tanezumab，REMS 計劃如何實施的期望？

What that might look like in terms of its impact on the launch of that product?

就其對該產品發布的影響而言，這可能是什麼樣的？

And then the second question is just relative to the data that we got recently or at least the headline announcement for atopic dermatitis with baricitinib.

然後第二個問題與我們最近獲得的數據或至少與巴瑞替尼治療特應性皮炎有關的頭條新聞有關。

Can you just give us a general sense of how you see those data competing in the market versus the existing product, DUPIXENT?

您能否大致了解一下您如何看待這些數據與現有產品 DUPIXENT 在市場上的競爭？

Thanks, Seamus.

謝謝，西莫。

We'll go with Dan for the expectations for the tanezumab REMS program.

我們將與 Dan 一起對 tanezumab REMS 計劃的期望。

Christi, if you want to weigh in on the commercial -- potential commercial impact, and then to Christi for bari atopic dermatitis.

克里斯蒂，如果你想權衡商業——潛在的商業影響，然後去克里斯蒂治療巴里特應性皮炎。

Yes.

是的。

Thanks for the question on tanezumab.

感謝有關 tanezumab 的問題。

Of course, we're excited to, one, with our partner Pfizer, announce the data on the latest Phase III trial.

當然，我們很高興與我們的合作夥伴輝瑞（Pfizer）一起公佈最新 III 期試驗的數據。

We still don't have the full data package, of course, on this molecule on OA.

當然，我們仍然沒有完整的數據包，關於 OA 上的這個分子。

As we said before though, we're very confident in the efficacy.

正如我們之前所說，我們對療效非常有信心。

We continue to see that replicated.

我們繼續看到這種情況被複製。

And that's encouraging that risk obviously we've been looking at is rapidly progressive osteoarthritis, RPOA, and the data that we continue to get, I think, is a very encouraging picture.

令人鼓舞的是，我們一直在關注的風險顯然是快速進展的骨關節炎，RPOA，我認為我們繼續獲得的數據是一幅非常令人鼓舞的畫面。

This molecule, I think, if you take the context of the vast unmet medical need for chronic pain and the deficiencies with the existing therapies that are available, including opioids and NSAIDs, I think really, this offers a compelling benefit.

我認為，如果考慮到對慢性疼痛的巨大未滿足的醫療需求以及現有療法（包括阿片類藥物和非甾體抗炎藥）的缺陷，我認為這種分子確實提供了令人信服的好處。

So we have to wait and see what the next trials read out, particularly the long-term safety study.

因此，我們必須拭目以待，看看接下來的試驗結果如何，尤其是長期安全性研究。

But if we can continue with the pattern of results that we've seen so far, I think we have great reason to be encouraged.

但是，如果我們能夠繼續我們迄今為止所看到的結果模式，我認為我們有充分的理由受到鼓勵。

With respect to your specific question about post approval, REMS and things like that, I would just say it's premature to discuss that.

關於您關於審批後、REMS 和類似問題的具體問題，我只想說現在討論這個問題還為時過早。

Let's get the full data package and then move forward with the FDA.

讓我們獲取完整的數據包，然後與 FDA 合作。

To what Dan is talking about, if you look at the commercial opportunity, a number of patients that are suffering from osteoarthritis is 27 million.

對於丹所說的，如果你看一下商業機會，患有骨關節炎的患者數量是 2700 萬。

And if you just look at the patients that are similar to what we enrolled in this study, 11 million of those patients are very similar, which is a spin on at least 3 different classes of analgesics.

如果你只看與我們在這項研究中登記的患者相似的患者，其中 1100 萬患者非常相似，這是至少 3 種不同類別的鎮痛劑的組合。

They've been -- it's been over 6 years.

他們已經 - 已經超過 6 年了。

It's -- they changed medications multiple times.

這是 - 他們多次更換藥物。

So the unmet need, even in the most severe market, is extremely high.

因此，即使在最嚴峻的市場中，未滿足的需求也非常高。

So as we look at the safety and REMS, et cetera, that high unmet need, the opportunity is still huge in the most severe patients.

因此，當我們著眼於安全性和 REMS 等高未滿足需求時，最嚴重的患者仍有巨大的機會。

Turning to atopic dermatitis, yes, we reported out positive results in terms of our atopic dermatitis, meeting our primary endpoints.

談到特應性皮炎，是的，我們報告了特應性皮炎方面的積極結果，符合我們的主要終點。

Recall, this is 2 of 5 studies, so we have 3 more readouts this year.

回想一下，這是 5 項研究中的 2 項，所以今年我們還有 3 項讀數。

That combination of studies will then support a global package.

這種研究組合將支持全球一攬子計劃。

Just to give you a little bit about the atopic dermatitis market, as you may or may not know, 54 million patients suffer from atopic dermatitis.

只是給您一點關於特應性皮炎市場的信息，您可能知道也可能不知道，5400 萬患者患有特應性皮炎。

18 million of those, moderate to severe.

其中1800萬，中度至重度。

And if you talk to thought leaders, whether it's one-on-one or from the podium, they see this market like the psoriasis market was 15 years ago.

如果你與思想領袖交談，無論是一對一還是在講台上，他們都會看到這個市場就像 15 年前的牛皮癬市場一樣。

And to be able to come to market with the very first oral is our goal as these patients suffer and need new therapies.

我們的目標是能夠將第一個口服藥物推向市場，因為這些患者正在遭受痛苦並需要新的治療方法。

And now we have -- from the line of Steve Scala with Cowen.

現在我們有了——來自 Steve Scala 和 Cowen 的系列。

I have 2 questions.

我有 2 個問題。

Were the baricitinib trials in atopic dermatitis only positive in the 4-milligram arm?

特應性皮炎中的巴瑞替尼試驗是否僅在 4 毫克組中呈陽性？

Or was statistical significance achieved on the 1- and 2-milligram cohorts as well?

還是在 1 和 2 毫克的隊列上也達到了統計顯著性？

And then the second question is, the impact on 2019 P&L of the Lartruvo failure was not small.

然後第二個問題是，Lartruvo 失敗對 2019 年 P&L 的影響不小。

I appreciate there are reasons for this.

我很感激這是有原因的。

But as we look to critical 2019 readouts, what can you tell us about their contribution to guidance?

但是，當我們關注 2019 年的關鍵讀數時，您能告訴我們它們對指導的貢獻嗎？

I am specifically thinking about the LOXO-292 LIBRETTO trial, the tanezumab safety trial, Trulicity AWARD-11 and Verzenio MONARCH plus trial.

我正在特別考慮 LOXO-292 LIBRETTO 試驗、tanezumab 安全試驗、Trulicity AWARD-11 和 Verzenio MONARCH plus 試驗。

Thank you.

謝謝你。

Christi, we'll have you answer the question on baricitinib and then go to Josh for the guidance question.

克里斯蒂，我們會讓你回答關於巴瑞克替尼的問題，然後去找喬希尋求指導問題。

Thanks, Steve.

謝謝，史蒂夫。

Yes.

是的。

So as you look at the trial, it included 3 doses: 1 milligram, 2 milligram and 4 milligram.

因此，當您查看試驗時，它包括 3 個劑量：1 毫克、2 毫克和 4 毫克。

1 milligram did not meet the primary endpoints, but 2 milligram and 4 milligram did meet the primary endpoint.

1 毫克未達到主要終點，但 2 毫克和 4 毫克確實達到了主要終點。

As you look at the pain and the global assessment, scores of 3 primary endpoints, 4 milligrams did meet all of those and 2 milligrams met 2 of the 3. So as we look at those, we know in atopic dermatitis market, the 4 milligrams in the [second] dose, it would be something that -- as we look at the total package, we'll be submitting to FDA for approval.

當您查看疼痛和全球評估時，3 個主要終點的得分，4 毫克確實滿足所有這些，2 毫克滿足 3 中的 2 個。因此，當我們查看這些時，我們知道在特應性皮炎市場中，4 毫克在 [第二] 劑中，這將是——當我們查看整個包裝時，我們將提交給 FDA 批准。

Steve, it's Josh.

史蒂夫，是喬希。

On the guidance, I'd first say that for all of the R&D -- pipeline that you mentioned, our R&D range, funds and contemplates, the success in those categories.

關於指導，我首先要說的是，對於你提到的所有研發——管道，我們的研發範圍、資金和考慮，以及這些類別的成功。

Obviously, with the Loxo addition, 292 is the primary driver of the $200 million R&D expansion in our line item guidance.

顯然，隨著 Loxo 的加入，292 是我們的項目指南中 2 億美元研發擴張的主要驅動力。

In terms of the top line, we look at all the opportunities and potential sales impacts and probabilize those, so they're contemplated in our range.

就收入而言，我們著眼於所有機會和潛在的銷售影響並將其概率化，因此它們被納入我們的範圍內。

Although I would say most of the things that you mentioned really will have more of an impact in 2020 to the extent that they're positive.

雖然我想說你提到的大多數事情在 2020 年確實會產生更大的影響，只要它們是積極的。

As I mentioned in the upfront comments, even with the impact of Lartruvo coming out, we're confident in our -- in achieving our sales goal for 2020, which would be the 7% compound annual growth rate for the pharma business between 2015 and 2020.

正如我在前期評論中提到的那樣，即使 Lartruvo 的影響出現了，我們對實現 2020 年的銷售目標充滿信心，這將是 2015 年至 2015 年間製藥業務的 7% 複合年增長率2020 年。

To achieve that, based on the guidance we're giving for 2019, that assumes the minimum growth of about 6%, and that's not dependent on any individual product launch or R&D readout at this point.

為了實現這一目標，根據我們為 2019 年提供的指導，假設最低增長率約為 6%，這並不依賴於目前任何單個產品的發布或研發讀數。

We're confident with the number of launches that we're in the midst of now.

我們對目前的發射數量充滿信心。

And the clinical data that are still accruing, we're confident that we can get that number in 2020.

而仍在積累的臨床數據，我們有信心在 2020 年獲得這個數字。

We'll go to Chris Schott with JPMorgan.

我們將與摩根大通一起去克里斯肖特。

My first one was on your expectation for a mid-single-digit decline in U.S. price.

我的第一個是關於你對美國價格下跌中個位數的預期。

I was wondering, do you guys see more granularity like you did in the 4Q about the drivers assumption?

我想知道，你們是否像第四季度那樣看到了關於驅動程序假設的更多粒度？

I guess, what I'm really trying to get here, should we be thinking about a similar dynamic like we saw in 4Q where it's channel mix and patient affordability initiatives are the primary drivers of price decline?

我想，我真正想要了解的是，我們是否應該考慮像我們在第四季度看到的類似動態，其中渠道組合和患者負擔能力計劃是價格下跌的主要驅動力？

Or is this more about greater [rebids] and contracting pressures driving that erosion?

或者這更多的是關於更大的[重新出價]和推動這種侵蝕的收縮壓力？

My second question was just about the operating margin targets as we think out to 2020 on pharma and if you're looking about a 200 basis point impact versus prior guidance on pharma for '19?

我的第二個問題是關於我們對 2020 年製藥業的預期營業利潤率目標，如果您正在尋找與 19 年製藥業先前指導相比 200 個基點的影響？

So can you just elaborate some of the dynamics as we think out to 2020 and what should we be thinking about for the pharma business there.

那麼，您能否詳細說明我們對 2020 年的思考以及我們應該為那裡的製藥業務考慮的一些動態。

Okay.

好的。

Thank you, Chris.

謝謝你，克里斯。

We'll go to Josh for both those questions.

這兩個問題我們都會去找喬希。

Chris, first, on the price decline for 2020 -- I mean, for 2019, so one thing that we have that is new in 2019 is the Medicare donut hole expansion, the move from 50% to 70%.

克里斯，首先，關於 2020 年的價格下跌——我的意思是，對於 2019 年，我們在 2019 年擁有的一件事是醫療保險甜甜圈洞擴張，從 50% 上升到 70%。

And that's got about a $200 million impact or close to 2 points of the mid-single-digit decline we'll have, so that's a new item in 2019.

這產生了大約 2 億美元的影響，或者接近我們將有的中個位數下降的 2 個百分點，所以這是 2019 年的一個新項目。

Otherwise, we are seeing generally the same things.

否則，我們通常會看到相同的事情。

We're seeing an increase in our patient affordability efforts, these are around Humalog.

我們看到我們在患者負擔能力方面的努力有所增加，這些都圍繞著 Humalog。

They're around new launches like Trulicity and Emgality, where we're very confident that those kind of impacts are positive in the long run, they lead the volume gains over time.

它們圍繞著 Trulicity 和 Emgality 等新產品推出，我們非常有信心，從長遠來看，這些影響是積極的，它們會隨著時間的推移引領銷量增長。

We're seeing that certainly in Taltz right now.

我們現在肯定在 Taltz 看到了這一點。

So we do expect a few points of drag there.

所以我們確實預計會有一些阻力。

And then I think the rest is mostly going to be either mix or small unit declines, but nothing that -- they're all sort of related to maintaining or improving access.

然後我認為其餘的主要是混合或小單位下降，但沒有什麼 - 它們都與維護或改善訪問有關。

We obviously are always looking at diabetes as a big segment, one that faces a lot of competition, but we're very happy with the access that we have going into 2019 and aren't -- I don't think you'll see any big new headwinds from a pricing perspective.

顯然，我們一直將糖尿病視為一個很大的部分，面臨著很多競爭，但我們對進入 2019 年的訪問感到非常滿意，而且不是——我認為你不會看到從定價的角度來看，任何新的重大阻力。

As it relates to the operating margin targets for 2020, yes, I think if you look at where -- the guidance we have for 2019, I think serves us about -- probably about 27% at the midpoint ranges.

由於它與 2020 年的營業利潤率目標有關，是的，我認為如果你看一下——我們對 2019 年的指導，我認為對我們有用——可能在中點範圍內約為 27%。

Remember, our guidance for 2020 now is to -- when you take out Elanco, as you get to 31, Elanco, when we take it out, gives us about 1 point or so of benefit.

請記住，我們現在對 2020 年的指導是——當你取出 Elanco 時，當你達到 31 歲時，當我們取出 Elanco 時，它會給我們帶來大約 1 點左右的收益。

So we -- yes, we're looking at about 300 basis points improvement versus our midpoint range this year to 2020.

所以我們 - 是的，我們正在考慮與今年到 2020 年的中點範圍相比提高約 300 個基點。

We think that's very achievable.

我們認為這是可以實現的。

If you look at -- in 2018, we improved operating margin by about 450 basis points.

如果你看一下——在 2018 年，我們將營業利潤率提高了約 450 個基點。

We got there through mid to high single digits top line growth and relatively flat expenses.

我們通過中高個位數的收入增長和相對平穩的支出實現了這一目標。

As I mentioned, we would -- to achieve our minimum revenue growth, we need about 6% growth in 2020, which we feel good about.

正如我所提到的，為了實現最低收入增長，我們需要在 2020 年實現約 6% 的增長，我們對此感覺良好。

So mid-single-digit top line growth with good control and expenses gives us, I think, a very good -- just mathematically gets us there.

因此，我認為，具有良好控制和支出的中等個位數的頂線增長給了我們一個非常好的 - 只是在數學上讓我們到達那裡。

So we're comfortable with the ability to achieve that minimum.

因此，我們對達到最低要求的能力感到滿意。

And that will be with Jason Gerberry with Bank of America Merrill Lynch.

那將是與美銀美林的傑森·格伯里 (Jason Gerberry) 一起。

This is [Chi] on for Jason.

這是傑森的[Chi]。

One on pricing and one on Emgality.

一個關於定價，一個關於 Emgality。

First one, can you just give a little color on how you think about the [investment on] (inaudible) reform on exclusive contracting, specifically on products like (inaudible) diabetest treatment?

第一個，您能否就您如何看待獨家承包的[投資]（聽不清）改革，特別是對（聽不清）糖尿病治療等產品的看法？

Just curious, does the company see an end to exclusive contracting (inaudible) taken broadly away?

只是好奇，公司是否認為排他性合同（聽不清）被廣泛取消？

Or does Lilly believe, [with our next] cost provider, we will win the exclusive contract?

或者禮來公司是否相信，[與我們的下一個]成本供應商，我們將贏得獨家合同？

Second, on Emgality, curious to know what -- how you think about the puts and takes for the progression of Emgality over 2019.

其次，關於 Emgality，很想知道什麼——你如何看待 Emgality 在 2019 年的進展。

As Lilly's focused on primary care, the reason that you might be lagging competitors in this space, given neuro and (inaudible) [specialists] are early adopters.

由於禮來專注於初級保健，您可能在這個領域落後於競爭對手，因為神經和（聽不清）[專家]是早期採用者。

And if you could just quickly comment on the Emgality pay subscription [rate], how it compared to (inaudible) [15%] right now, that would be great.

如果您可以快速評論 Emgality 付費訂閱 [rate]，與現在（聽不清）[15%] 相比如何，那就太好了。

Okay, thank you.

好的謝謝你。

We'll go to Enrique for the question on Part D rebates, and then Christi for Emgality.

我們將向 Enrique 詢問關於 D 部分回扣的問題，然後向 Christi 詢問 Emgality。

Yes.

是的。

I'm not sure that I understood the full question.

我不確定我是否理解了完整的問題。

But at this point in time, I think as we look at the status quo, well, we basically see the continued trends when it comes to exclusive contracting.

但是在這個時間點上，我認為當我們看現狀時，我們基本上看到了獨家承包方面的持續趨勢。

As we all know, [muta insulins] is already contracted that way.

眾所周知，[muta 胰島素] 已經以這種方式收縮。

And we see basically trends where most payers are trying to restrict utilization, maybe have a few of our products and extract rebates and concessions clearly.

而且我們基本上看到大多數付款人試圖限制使用的趨勢，可能有我們的一些產品並清楚地提取回扣和讓步。

Right now, there's some uncertainty when it comes to the new proposed rule.

目前，新提議的規則存在一些不確定性。

And we really need to see how that is going to play out.

我們真的需要看看這將如何發揮作用。

I won't be able to speculate at this time.

我暫時無法推測。

Yes.

是的。

And on Emgality, we're so excited with the number of patients that are being helped by the CGRP agents.

在 Emgality 上，我們對 CGRP 代理幫助的患者數量感到非常興奮。

We expect probably 6 million patients to be eligible.

我們預計可能有 600 萬患者符合條件。

If you look at Emgality specifically in your questions, we launched in October obviously, so we just have a couple of months of data.

如果您在問題中專門查看 Emgality，我們顯然是在 10 月推出的，所以我們只有幾個月的數據。

But right now what we're seeing is similar that our paid subscriptions are right about 50%.

但現在我們看到的情況與我們的付費訂閱相似，大約是 50%。

The marketplace splits up.

市場分裂。

About 1/3 of prescriptions come from primary care, 1/3 come from neurologists and 1/3 come from mid levels.

大約 1/3 的處方來自初級保健，1/3 來自神經科醫生，1/3 來自中等水平。

So this very much will be an expansion into primary care beyond the neurologists as well.

因此，這將在很大程度上擴展到神經科醫生之外的初級保健領域。

Specifically, looking at Emgality's performance, we ended the year, even though we launched late, at a 20% NBRx, and we're currently looking at 26% already in January.

具體來說，看看 Emgality 的表現，儘管我們推出較晚，但我們以 20% 的 NBRx 結束了這一年，而我們目前在 1 月份已經看到了 26%。

So as you look at these launches, we just launched our direct-to-consumer TV ad campaign this week.

因此，當您查看這些發佈時，我們本周剛剛發布了直接面向消費者的電視廣告活動。

We know that Lilly has very strong consumer activation relative to our competitors.

我們知道，相對於我們的競爭對手，禮來的消費者激活度非常高。

We know that we have a drug that has not just demonstrated 50% improvement but 75% and 100% reduction in monthly headaches that our competitors don't have as well as quality of life.

我們知道，我們有一種藥物不僅顯示出 50% 的改善，而且每月的頭痛減少了 75% 和 100%，這是我們的競爭對手所沒有的以及生活質量。

And we have unique platform and device that Trulicity uses that we know over 1 million patients really like.

我們擁有 Trulicity 使用的獨特平台和設備，我們知道超過 100 萬患者非常喜歡。

So we're very bullish on both the market and on Emgality's ability to compete.

因此，我們非常看好市場和 Emgality 的競爭能力。

That will be Louise Chen with Cantor.

那將是與 Cantor 一起的 Louise Chen。

My first question here is how long do you think it will take for Trulicity sales to benefit from your REWIND presentation at ADA?

我的第一個問題是，您認為 Trulicity 的銷售需要多長時間才能從您在 ADA 的 REWIND 演示中受益？

And what type of uptake do you think we should see after that?

你認為在那之後我們應該看到什麼類型的吸收？

And then secondly, on the market opportunity for lasmitidan, just curious how you think about it now in light of the injectable PDRPs being approved and the potential for oral PDRPs to come to the market?

其次，關於 lasmitidan 的市場機會，只是想知道鑑於可注射 PDRP 已獲批准以及口服 PDRP 進入市場的潛力，您現在如何看待它？

Thank you.

謝謝你。

So Enrique will take Trulicity, and then Christi will handle the question on lasmiditan.

所以 Enrique 將接受 Trulicity，然後 Christi 將處理有關 lasmiditan 的問題。

Clearly, Trulicity is -- has an outstanding run right now and benefiting from a huge growth of the GLP-1 market.

顯然，Trulicity 目前表現出色，並受益於 GLP-1 市場的巨大增長。

If anything, we are seeing the GLP-1 market accelerate from already very high levels, growing at nearly 30% on a year-on-year basis.

如果有的話，我們看到 GLP-1 市場從已經非常高的水平開始加速，同比增長近 30%。

And importantly, in the market, Trulicity has continued to perform well and we've been able to gain share, in fact, over 5 share points since the launch of Ozempic.

重要的是，在市場上，Trulicity 繼續表現良好，事實上，自 Ozempic 推出以來，我們已經獲得了超過 5 個份額點。

Now as we look at REWIND, clearly, we see that this is a critical trial and data set that is going to benefit patients.

現在，當我們看 REWIND 時，我們清楚地看到，這是一項重要的試驗和數據集，將使患者受益。

The big impact is when we basically start promotion of this important data.

最大的影響是當我們基本上開始推廣這些重要數據時。

And I think it basically solidifies, I think, the bright future that Trulicity already had.

我認為它基本上鞏固了 Trulicity 已經擁有的光明未來。

We expect that impact, of course, sometime in the 2020 once we get the FDA action on the new label.

當然，一旦 FDA 對新標籤採取行動，我們預計會在 2020 年的某個時候產生這種影響。

Yes.

是的。

And then on lasmiditan and how it will play in the marketplace, we will have some regulatory action this year.

然後關於 lasmiditan 及其在市場上的表現，我們今年將採取一些監管行動。

So we're looking forward to that.

所以我們很期待。

If you look at the marketplace, kind of how we look at it with the 36 million patients who suffer from migraine, there's about 16 million of those that are diagnosed and 6 million that suffer from acute migraines and are taking therapy.

如果你看看市場，就像我們對 3600 萬偏頭痛患者的看法一樣，大約有 1600 萬患者被診斷出患有急性偏頭痛并正在接受治療。

And that is overlapping only somewhat with the prevention market.

這只是在某種程度上與預防市場重疊。

So as you look at prevention, CGRPs versus acute use, there's obviously a huge need for both distinctly.

因此，當您查看預防、CGRP 與急性使用時，顯然對兩者都有巨大的需求。

And CGRPs also obviously don't clear 100% of all patients of their migraines, so we see -- the use obviously may overlap there.

而且 CGRP 顯然也不能 100% 清除所有患者的偏頭痛，所以我們看到 - 使用顯然可能在那裡重疊。

And we think lasmi is -- has a really great positioning versus the oral CGRPs.

我們認為 lasmi 與口服 CGRP 相比具有非常好的定位。

If you're taking a preventive CGRP, you may want to look at a different mechanism if you have to add to that.

如果您正在服用預防性 CGRP，如果您必須添加其他機制，則可能需要查看不同的機制。

And then if we look at the acute marketplace, so many patients have fallen out of the market because of lack of efficacy or they can't tolerate the safety, so lasmitidan will be a great option for them.

然後如果我們看一下急性市場，有很多患者因為缺乏療效或不能耐受安全性而退出市場，所以拉斯米丹對他們來說將是一個很好的選擇。

That will be from Alex Arfaei with BMO Capital Markets.

這將來自 BMO Capital Markets 的 Alex Arfaei。

Verzenio was -- notably blew our expectations.

Verzenio - 明顯超出了我們的預期。

You mentioned buying patterns in the U.S. impacted this.

您提到美國的購買模式對此產生了影響。

Could you please quantify the inventory impact and your latest long-term expectations for this product, given the apparent slowdown in the CDK4/6 market?

鑑於 CDK4/6 市場明顯放緩，您能否量化庫存影響和您對該產品的最新長期預期？

And just a follow-up, a bigger picture question on your operating margin.

只是一個跟進，一個關於你的營業利潤率的更大的問題。

I'm just trying to look past 2020 here.

我只是想在這裡回顧一下 2020 年。

Historically, you've invested more in internal innovations as opposed to external innovation.

從歷史上看，與外部創新相比，您在內部創新上的投資更多。

And with that higher R&D, your operating margin was relatively lower to your peers.

有了更高的研發，你的營業利潤率相對於你的同行來說相對較低。

Now that you've seen [somewhat] more balanced approach with the increased contribution from acquisitions, as your top line grows in the mid-single digits, is it reasonable to expect that Lilly can get to mid-30s operating margins?

既然您已經看到[在某種程度上] 更加平衡的方法與收購的貢獻增加，隨著您的收入以中個位數增長，那麼預期禮來可以達到 30 年代中期的營業利潤率是否合理？

Okay.

好的。

Thank you.

謝謝你。

We'll go to Anne for the question on Verzenio, and then Dave will take the question on operating margin post 2020.

我們將向 Anne 詢問有關 Verzenio 的問題，然後 Dave 將回答有關 2020 年後營業利潤率的問題。

Thanks, Alex, for the question.

謝謝亞歷克斯的問題。

So we saw about $4 million inventory impact in 2018.

因此，我們在 2018 年看到了大約 400 萬美元的庫存影響。

And as you mentioned, we are seeing flattening in the CDK4/6 market as penetration has occurred.

正如您所提到的，隨著滲透的發生，我們看到 CDK4/6 市場趨於平緩。

With Verzenio, our focus is clearly on execution to drive new Verzenio -- new trial of Verzenio and increasing our share of market.

對於 Verzenio，我們的重點顯然是執行以推動新的 Verzenio——Verzenio 的新試驗並增加我們的市場份額。

We're not -- on a positive note, we're encouraged that we're seeing high conversion rates with over 50% of physicians who trial Verzenio moving on to write additional prescriptions.

我們不是——從積極的方面來說，我們看到高轉化率是令人鼓舞的，超過 50% 的試用 Verzenio 的醫生繼續開出額外的處方。

We're also really looking forward to the launches outside the U.S. So we've launched in Japan and in several countries in Europe, and the uptake has been strong as well.

我們也非常期待在美國以外的地區推出產品。所以我們已經在日本和歐洲的幾個國家推出了產品，而且吸收也很強勁。

In particular, what we're seeing is a good uptake in patients with a poor prognosis.

特別是，我們看到的是預後不良的患者的良好吸收。

And so that will be patients with visceral disease or liver metastases.

因此，這將是患有內臟疾病或肝轉移的患者。

So we're also driving execution in there.

所以我們也在推動執行。

So we have hope for continued growth for Verzenio as we really focus on a strong year of execution across the globe.

因此，我們對 Verzenio 的持續增長抱有希望，因為我們真正專注於全球強勁的執行年。

Yes.

是的。

And as it relates to sort of margins and long-term R&D strategy, it's a good question.

由於它涉及到某種利潤和長期研發戰略，這是一個很好的問題。

I know there's a lot of appetite for us to nail down some long-term target number.

我知道我們很想確定一些長期目標數字。

We're not going to do that because I think, really, at the core of this is the question, what are our opportunities, which we don't have full visibility to beyond 2020.

我們不會那樣做，因為我認為，真正的核心是一個問題，我們的機會是什麼，我們對 2020 年以後沒有完全的了解。

But let me just tell you how we think about this.

但讓我告訴你我們是如何看待這個問題的。

We see a period ahead of prolonged revenue growth for the company because we have a relatively new lineup of products that should continue to grow.

我們認為該公司的收入將持續增長一段時間，因為我們有一個相對較新的產品陣容，應該會繼續增長。

We're adding to that even this year and next with additional launches.

即使在今年和明年，我們也會通過額外的發布來增加這一點。

We do see ourselves balancing R&D spending, both the balance sheet, M&A as well as partnerships and continue to spend to the -- I would say, toward the top of the industry on internal income statement based R&D because we see good opportunities today.

我們確實看到自己平衡了研發支出，包括資產負債表、併購以及合作夥伴關係，並繼續在基於內部損益表的研發方面投入到行業的頂端，因為我們今天看到了很好的機會。

But that is not a fixed line item, it's based on what we see in front of us and the opportunity to create value for shareholders and patients with innovation.

但這不是一個固定的項目，它基於我們眼前所見，以及為股東和患者創造價值的創新機會。

I would expect long term to continue to see, as we grow top line, better gross margins and better SG&A as a percent of sales, so those will be helpful long term to that continuing expansion.

我預計長期來看，隨著我們的收入增長，毛利率和銷售費用佔銷售額的百分比更好，這些將有助於長期持續擴張。

R&D will be more a function of our choice making on growth drivers for the future, and it's hard to speculate on which direction that would go.

研發將更多地取決於我們對未來增長動力的選擇，很難推測會朝哪個方向發展。

We would hope actually to be able to spend more because that would mean the science is promising, and we see opportunities to grow the value of the company and improve therapies for patients.

我們實際上希望能夠花更多的錢，因為這意味著科學是有前途的，我們看到了提高公司價值和改善患者治療方法的機會。

We'll go to Geoff Meacham with Barclays.

我們將和巴克萊一起去 Geoff Meacham。

I just had a few.

我只有幾個。

Enrique, you saw some good sequential trends for Jardiance in 3Q as well as 4Q.

Enrique，你看到了 Jardiance 在第三季度和第四季度的一些良好的連續趨勢。

So the question is, what do you attribute that to?

所以問題是，你把它歸因於什麼？

And should the demand backdrop continue into in 2019?

需求背景是否會持續到 2019 年？

I know most investors were initially expecting more of an inflection after EMPA-REG.

我知道大多數投資者最初預計在 EMPA-REG 之後會有更多的變化。

It hasn't happened yet, but are you seeing signs of that happening now.

它還沒有發生，但你現在是否看到了正在發生的跡象。

And then just bigger picture for Josh, on the back of the Loxo deal, obviously, you guys have broadened -- even more broadened your oncology presence.

然後，在 Loxo 交易的背後，對於 Josh 來說，這只是更大的圖景，顯然，你們已經擴大了——甚至更多地擴大了你們的腫瘤學領域。

So from maybe a capacity or from a priority standpoint, where do you see BD fitting in?

因此，從容量或優先級的角度來看，您認為 BD 適合什麼？

Is there a therapeutic category that you feel like you maybe need a little bit of help then?

是否有一個治療類別，你覺得你可能需要一點幫助？

Thanks.

謝謝。

Enrique?

恩里克?

Very good.

很好。

As we look at 2019, I'm particularly bullish when it comes to Jardiance because we have a number of inflection points that I think are playing as strong tailwinds for the success of the product.

展望 2019 年，我特別看好 Jardiance，因為我們有許多拐點，我認為這些拐點正在為產品的成功發揮強大的推動作用。

As you know, we have new updated ADA and EASD guidelines, I think, that place emphasis on SGLT2s, but in particular preference for Jardiance within that class.

如您所知，我認為我們有新的更新的 ADA 和 EASD 指南，強調 SGLT2，但在該課程中特別偏愛 Jardiance。

Clearly, we have the reinclusion of Jardiance in the CVS formularies and that's pretty significant, and that now Jardiance has basically 90-plus access across commercial and Part D. It is likely that we're seeing, as we look at some of the data, when we look at January -- when we look at market data, it is likely that we're seeing some spillover effect of that reinclusion, even beyond some of the formulary itself.

顯然，我們將 Jardiance 重新納入 CVS 處方集，這非常重要，現在 Jardiance 基本上擁有 90 多個跨商業和 D 部分的訪問權限。當我們查看一些數據時，我們很可能會看到，當我們查看 1 月份時——當我們查看市場數據時，我們很可能會看到重新納入的一些溢出效應，甚至超出了一些公式本身。

Jardiance now, it's basically running around in the low to mid-60s when it comes to NBRx share.

現在，Jardiance 在 NBRx 份額方面基本上處於 60 年代中期。

And we're actually seeing the SGLT2 class accelerate and now basically showing growth in double digits.

我們實際上看到 SGLT2 類加速，現在基本上顯示出兩位數的增長。

I think all of that, I think, is very encouraging.

我認為所有這些都非常令人鼓舞。

And finally, given the profile that we basically have, the increased investment in terms of our competitors, we see that also as beneficial to the product.

最後，鑑於我們基本上擁有的形象，對競爭對手的投資增加，我們認為這對產品也有好處。

So very bullish in terms of how I see this overall class accelerating and more importantly, Jardiance basically capitalizing as the share leader.

就我如何看待整個班級的加速發展而言，非常樂觀，更重要的是，Jardiance 基本上將資本化為股票領導者。

Thanks for the question.

謝謝你的問題。

I think as it relates to business department capacity and interest, first, I'd go back to Dave's earlier comments about how we think about the future.

我認為，由於它與業務部門的能力和興趣有關，首先，我會回到戴夫早些時候關於我們如何看待未來的評論。

We see a period of good growth in front of us, and that good sales growth and operating income growth translates to strong cash flow generation.

我們看到了一段良好的增長期，良好的銷售增長和營業收入增長轉化為強勁的現金流產生。

So I think in terms of capacity, we feel like we've got very good capacity going forward.

所以我認為就容量而言，我們覺得我們未來的容量非常好。

So really, from a business development perspective, we're going to be mostly constrained by the opportunities that we see.

所以真的，從業務發展的角度來看，我們將主要受到我們所看到的機會的限制。

We're not particularly tilted towards one therapeutic area.

我們並不特別傾向於一個治療領域。

It's really the therapeutic areas that we're invested in today when we see good assets.

當我們看到良好的資產時，這確實是我們今天投資的治療領域。

Where we like the science, can enhance the portfolio and can create value for shareholders with the acquisition, we'll pursue those and we'll pursue them aggressively.

在我們喜歡科學、可以增強投資組合併可以通過收購為股東創造價值的地方，我們將追求這些，我們將積極追求它們。

I think just given where investment and the progression of opportunities and science is, you'd have to expect that we will continue to be looking in -- oncology and immunology are 2 areas where there's just a lot of opportunity.

我認為，考慮到投資以及機會和科學的進步，你必須期待我們將繼續關注——腫瘤學和免疫學是兩個有很多機會的領域。

But all of our therapeutic areas are open for us and when we can find the best assets, really, we've got the balance sheet and cash flow capacity to act.

但是我們所有的治療領域都對我們開放，當我們能找到最好的資產時，真的，我們就有了資產負債表和現金流能力來採取行動。

That will be David Risinger with Morgan Stanley.

那將是摩根士丹利的 David Risinger。

First, could you please discuss the forthcoming LOXO-292 readouts to watch?

首先，您能否討論一下即將觀看的 LOXO-292 讀數？

And if possible, it would be helpful if you could characterize what percentage of patients could be candidates in each tumor type.

如果可能的話，如果你能描述在每種腫瘤類型中有多少患者可以成為候選者，那將會很有幫助。

Second, with respect to Novo's oral semaglutide, I think the expectation is that it will be priced lower as an oral.

其次，關於諾和的口服索馬魯肽，我認為預期它作為口服的價格會更低。

Could you discuss potential implications for the GLP-1 market, including Trulicity?

您能否討論對 GLP-1 市場（包括 Trulicity）的潛在影響？

And then I just have one little [nit] question, which is for Trajenta, the CAROLINA study versus sulphonylurea completed 6 months ago in August, when should we expect the top line?

然後我只有一個小 [nit] 問題，這是針對 Trajenta 的，CAROLINA 對磺脲類藥物的研究於 6 個月前於 8 月完成，我們什麼時候可以期待最高線？

Okay, thank you.

好的謝謝你。

We'll go to Anne for LOXO, and then Enrique will take the final 2 questions.

我們會去 Anne 做 LOXO，然後 Enrique 會回答最後兩個問題。

Yes.

是的。

So for LOXO-292, you can expect to see an additional readout at the scientific meeting in the second half of 2019, so we'll be looking forward to that.

所以對於 LOXO-292，你可以期待在 2019 年下半年的科學會議上看到額外的讀數，所以我們會很期待。

The study, the LIBRETTO study is enrolling very well.

這項研究，LIBRETTO 研究的招生非常好。

It has over 300 patients in it now.

它現在有300多名患者。

And so there will be robust data reported at the end of this year.

因此，今年年底將報告可靠的數據。

Importantly, as we thought, some of the data that's reported last year at some of the various meetings such as [World Onc], we saw our response rates between 60% and 80%, depending on the tumor type, and then seeing patients stay on therapy 90% or higher, staying on that therapy.

重要的是，正如我們認為的那樣，去年在 [World Onc] 等各種會議上報告的一些數據，我們看到我們的反應率在 60% 到 80% 之間，具體取決於腫瘤類型，然後看到患者留下來接受治療 90% 或更高，繼續接受該治療。

So we remain very excited and encouraged by the 292 data.

因此，我們仍然對 292 個數據感到非常興奮和鼓舞。

We think it's transformative for patients with RET fusions or mutations, and so you'll continue to hear more from that.

我們認為它對 RET 融合或突變的患者俱有變革性，因此您將繼續從中聽到更多信息。

On the actual incidence rates, what to -- what we know as far as some conversations with thought leaders and also reviewed literature is that with RET fusions in lung cancer, it happens in about 2% to 3% of lung cancers.

關於實際發病率，就我們與思想領袖的一些對話和回顧的文獻而言，我們所知道的是，在肺癌中使用 RET 融合，它發生在大約 2% 到 3% 的肺癌中。

And so as you know, that's a substantial market.

如您所知，這是一個巨大的市場。

And so that's one of the largest growth opportunities.

這是最大的增長機會之一。

That could be over 3,000 patients in the U.S. In papillary RET fusions, it's about 10% to 20%, a smaller population, but again, a very strong response rate in those patients.

在美國，這可能是 3,000 多名患者。在乳頭狀 RET 融合中，約佔 10% 到 20%，人口較少，但同樣，這些患者的反應率非常高。

And then in a tumor such as medullary thyroid, which has activating RET point mutations, that actually happens to about 60% of those patients that they see that RET mutation.

然後在像甲狀腺髓樣這樣的腫瘤中，它具有激活的 RET 點突變，實際上發生在大約 60% 的患者身上，他們看到了 RET 突變。

And so again, that could be an additional 500 patients in the U.S. alone, and then you start to include the global numbers.

再說一次，僅在美國就可能增加 500 名患者，然後您開始將全球數字包括在內。

So while the numbers, the incident rates are not high, the response rates are really remarkable.

因此，雖然事件發生率並不高，但響應率確實非常顯著。

And so we do believe that we'll see strong penetration and also a longer durability response.

所以我們相信我們會看到強大的滲透力和更長的耐久性響應。

So again, very, very excited about -- looking forward to those readouts.

再次，非常非常興奮 - 期待這些讀數。

Very good.

很好。

David, thank you for the question on oral sema.

大衛，謝謝你關於口頭 sema 的問題。

There is a question for Novo Nordisk.

諾和諾德有一個問題。

Unfortunately, I'm unable to really speculate on how they're going to price their product and some of the implications.

不幸的是，我無法真正推測他們將如何定價他們的產品以及一些影響。

First, Trajenta and CAROLINA, we expect really to release the top -- result this quarter, the top line results.

首先，Trajenta 和 CAROLINA，我們預計本季度將真正發布頂級業績，即頂級業績。

We'll go to Vamil Divan with Crédit Suisse.

我們將與瑞士信貸一起前往 Vamil Divan。

First on Olumiant, just following up on some of the earlier questions, I know the formula gram dose may be coming, but at least for now, the 2-milligram dose in the U.S., how should we think about the uptake potential, I guess, save for this year?

首先在 Olumiant 上，只是跟進一些較早的問題，我知道配方克劑量可能即將到來，但至少目前，美國的 2 毫克劑量，我們應該如何考慮吸收潛力，我猜，為今年存錢？

Maybe early next year, it's pretty limited, sales in the fourth quarter at least, so just as a view of the (inaudible) U.S. dynamics there.

也許明年初，至少在第四季度的銷售額非常有限，所以只是作為（聽不清）美國動態的看法。

And then for Emgality, I appreciate all the comments you made there on the dynamics.

然後對於 Emgality，我感謝您在那裡對動態所做的所有評論。

But just curious how you're seeing the discount you were saving, the net pricing evolved for that market with 3 players in the space.

但只是好奇您如何看待節省的折扣，該市場的淨定價演變為該市場有 3 個參與者。

It looks like you guys have done pretty well in terms of gaining access based on announcements you've seen, but any longer-term insights would be helpful.

看起來你們在根據您看到的公告獲得訪問權方面做得很好，但任何長期的見解都會有所幫助。

Sure.

當然。

Thanks, Vamil, for the questions.

謝謝，瓦米爾，為問題。

So I guess, I'll take both of those.

所以我想，我會接受這兩個。

I'm sorry, Kevin, I can't just fit in there in front of you.

對不起，凱文，我不能就在你面前。

So on Olumiant, what we see across the globe is really strong uptake, especially with our clinical experience that these patients are having, fast pain relief.

所以在 Olumiant 上，我們在全球範圍內看到的是非常強烈的吸收，特別是根據我們對這些患者的臨床經驗，快速緩解疼痛。

And what we see with the 2 versus the 4 is similar from an efficacy standpoint.

從功效的角度來看，我們看到的 2 與 4 是相似的。

The ACR20, it's about 1% less and 2 versus the 4 milligram, and ACR70, it's about 4% less.

ACR20 比 4 毫克少 1% 和 2，而 ACR70 少 4% 左右。

So in the U.S., those physicians who have tried it -- and the patients' feedback has been extremely positive.

所以在美國，那些嘗試過的醫生——以及患者的反饋都非常積極。

Obviously, in the U.S., our indication places us post-TNF.

顯然，在美國，我們的適應症使我們處於 TNF 之後。

At a 60% discount to the market leader, our access hasn't been an issue.

以市場領先者 60% 的折扣，我們的訪問權限不是問題。

And we think this will be a continuing growth product in that small market that we're playing in right now.

我們認為這將是我們目前正在參與的那個小市場的持續增長產品。

We obviously continue to look at the 4 milligram across multiple indications, as I talked about earlier with atopic dermatitis, lupus.

正如我之前談到的特應性皮炎狼瘡一樣，我們顯然會繼續關注 4 毫克的多種適應症。

Obviously, the discussion's ongoing with rheumatoid arthritis, et cetera.

顯然，關於類風濕性關節炎等的討論正在進行中。

So we're still very confident in that dose and the benefit risk profile of that.

所以我們仍然對那個劑量和它的收益風險狀況非常有信心。

As I move on to Emgality then, thanks for asking about the discounting and the net pricing because I forgot to mention, we're very excited to know that starting February 1, we will have best-in-class access in 2019 versus the other CGRPs.

然後，當我轉到 Emgality 時，感謝您詢問折扣和淨定價，因為我忘了提及，我們很高興知道從 2 月 1 日開始，我們將在 2019 年獲得一流的訪問權限，而不是其他CGRP。

We are on all 3 major PBMs.

我們在所有 3 個主要的 PBM 上。

There has been only one regional player, small regional player that has not put us -- disadvantaged us to get a CGRP.

只有一個區域性的玩家，小的區域性玩家沒有讓我們 - 使我們處於不利地位，無法獲得 CGRP。

So we have wide open access and relative to our competitors, better access.

因此，我們擁有廣泛開放的訪問權限，並且相對於我們的競爭對手而言，訪問權限更好。

I can't really comment on the discounting piece.

我真的不能評論打折片。

I can tell you now, what we're seeing as a marketplace out is the sampling happens in the physician's office.

我現在可以告訴你，作為一個市場，我們看到的是抽樣發生在醫生辦公室。

We started right away in the physician office sampling and in retail.

我們立即開始在醫生辦公室取樣和零售。

So what you see in our NBRx rates is actually not -- no samples in there as pure play, only the co-pay piece of it.

所以你在我們的 NBRx 費率中看到的實際上不是——那裡沒有純粹的樣本，只有共同支付的部分。

And what you see with the market dynamics as well, gotten a lot of questions on it, the market is flat.

你看到的市場動態也有很多問題，市場是平的。

We think the market continues to grow.

我們認為市場將繼續增長。

Huge opportunity, up to 6 million patients.

巨大的機會，多達 600 萬患者。

And with the market dynamics of our competitors changing from specialty mail order into retail has kind of made that market chart look a little bit flat versus what we actually think the underlying demand is.

隨著我們競爭對手的市場動態從專業郵購轉變為零售，與我們實際認為的潛在需求相比，該市場圖表看起來有點平淡。

We'll go to Andrew Baum with Citi.

我們將和花旗一起去安德魯鮑姆。

This is [Benito Grovan] for Andrew Baum at Citi.

我是花旗的 Andrew Baum 的 [Benito Grovan]。

I have 2 questions please.

請問我有2個問題。

The first one is while the (inaudible) pricing proposal might reduce near-term political pressure and [growth] price affordability, how concerned are you that it (inaudible) to be much more profitable commercial plans with material negative pricing implications for you.

第一個問題是，雖然（聽不清）定價提案可能會降低近期的政治壓力和 [增長] 價格承受能力，但您對（聽不清）更有利可圖的商業計劃對您有重大的負面定價影響有多擔心。

Secondly, do you think the second (inaudible) strategy for Medicare formularies is commercially viable?

其次，您認為醫療保險處方集的第二種（聽不清）策略在商業上可行嗎？

Or does it materially increase those costs (inaudible) at independent pharmacies?

或者它是否會顯著增加獨立藥房的成本（聽不清）？

So we'll go to Dave for the initial question on the pricing pressure and what we're seeing in the government and any potential spillover to the managed care, and then we might need to come back for clarification on the second question.

因此，我們將向戴夫詢問有關定價壓力的最初問題，以及我們在政府中看到的情況以及對管理式醫療的任何潛在溢出效應，然後我們可能需要回過頭來澄清第二個問題。

Yes.

是的。

I'm not sure I got all the detail of your question, but it's -- I guess, so I'll just caveat this answer by saying it's difficult to speculate right now.

我不確定我得到了你問題的所有細節，但它是 - 我想，所以我只是警告這個答案，說現在很難推測。

Of course, it seems like nearly every week, we see some new proposed regulatory rule or introduction of some idea on the Hill as it relates to U.S. drug pricing.

當然，似乎幾乎每週，我們都會看到一些新的監管規則或在希爾上引入一些與美國藥品定價相關的想法。

I'll give you a long-term outlook, which is, as an innovative based company, we're, of course, very excited about the underlying signs in this industry and what it can do.

我會給你一個長期的展望，即作為一家以創新為基礎的公司，我們當然對這個行業的潛在跡象及其能做的事情感到非常興奮。

The products who's been -- speaking about today are good examples of that.

今天談論的產品就是很好的例子。

And I think an innovation-based strategy is the way to overcome whatever the pricing pressures are out there.

我認為基於創新的戰略是克服任何定價壓力的方法。

So we like where we sit.

所以我們喜歡我們坐的地方。

We're in a period of strong growth and we've got innovation flowing now as well as recently launched that gives us a strong base going forward.

我們正處於一個強勁增長的時期，我們現在和最近推出的創新都在流動，這為我們的未來發展奠定了堅實的基礎。

We'll adapt to whatever rules come out and how they get finalized.

我們將適應出現的任何規則以及它們如何最終確定。

No doubt, I would say it's fair to say the administration is focused on both government formularies as well as spillover into commercial markets.

毫無疑問，我想說，政府既關注政府規定，又關注商業市場的溢出效應，這是公平的。

We think that's fine.

我們認為這很好。

It's probably difficult to run 2 systems side by side.

並排運行 2 個系統可能很困難。

And their top priority is actually our top priority, which is lowering out-of-pocket costs for patients at the pharmacy counter.

他們的首要任務實際上是我們的首要任務，即降低藥房櫃檯患者的自付費用。

So things like in the new rebate rule, this ability to pass-through savings in a chargeback form or some other form, even as early as this year into Part D plan participants, that's a great idea, and I think that's highly consistent with the policy positions we've taken before.

因此，在新的回扣規則中，這種以退款形式或其他形式傳遞儲蓄的能力，甚至早在今年進入 D 部分計劃參與者，這是一個好主意，我認為這與我們以前採取的政策立場。

We'll have to see how the dynamics evolve.

我們必須看看動態是如何演變的。

But Lilly has got a very strong capacity and capability in managed markets and in working with payer customers, that will serve us well as we navigate this period change.

但禮來在託管市場和與付款客戶合作方面擁有非常強大的能力和能力，這將在我們應對這一時期的變化時為我們提供良好的服務。

And I'm confident, based on innovation, we'll emerge successful.

我有信心，基於創新，我們將取得成功。

Could you please repeat the second question and -- so we can try to answer that for you?

請您重複第二個問題，然後我們可以嘗試為您回答這個問題？

We didn't pick it up, and there were...

我們沒有撿起它，而且有...

So do you think the second [entity] brand strategy for the Medicare formularies is commercially viable?

那麼你認為醫療保險處方集的第二個[實體]品牌戰略在商業上可行嗎？

Or does it materially increase [other costs] at independent pharmacies in the sense that the pharmacies (inaudible) lower-priced drug but (inaudible) for the high-priced drug?

還是從藥房（聽不清）低價藥但（聽不清）高價藥的意義上說，它是否會顯著增加獨立藥店的[其他成本]？

Maybe I'll try to provide an answer to that question, this is Enrique.

也許我會嘗試回答這個問題，這是恩里克。

We do review all options available to us, including potentially having a second brand.

我們確實審查了我們可用的所有選項，包括可能擁有第二個品牌。

There are a number of reasons where a second brand could be viable, and it really depends on the specific situation for the products.

第二個品牌可行的原因有很多，這實際上取決於產品的具體情況。

So that's something that we always study very carefully, but I'm not prepared to comment on that at this time.

所以這是我們一直非常仔細研究的東西，但我現在不准備對此發表評論。

We'll go to Umer Raffat with Evercore ISI.

我們將與 Evercore ISI 一起前往 Umer Raffat。

First, I noticed in the -- in some of the deal documents that came out on the Loxo deals, there was a sales estimate from Loxo management of about $40 million for 2020.

首先，我注意到在一些關於 Loxo 交易的交易文件中，Loxo 管理層估計 2020 年的銷售額約為 4000 萬美元。

Can you comment on that?

你能對此發表評論嗎？

And maybe just give us a little more specifics on -- specific metrics on what extent of testing is already happening and how do you see that changing, let's say, by year-end 2019.

也許只是給我們一些更具體的細節 - 關於已經發生的測試程度以及你如何看待這種變化的具體指標，比如說，到 2019 年底。

Okay, thanks.

好的謝謝。

We'll have Anne take those questions.

我們會讓安妮回答這些問題。

Well, on the going forward sales forecast, we don't comment on those specifically, and so I won't comment on that, the details of forecasted sales.

好吧，關於未來的銷售預測，我們不會具體評論那些，所以我不會評論預測銷售的細節。

We do -- this is obviously the launch year for Vitrakvi, and so I think it's too soon to comment.

我們這樣做了——這顯然是 Vitrakvi 的發布年，所以我認為現在評論還為時過早。

I believe they would say that things are off to a good start.

我相信他們會說事情有了一個良好的開端。

But again, we'll have to see the full year performance before we can comment on future performance.

但同樣，我們必須先看看全年的表現，然後才能評論未來的表現。

As far as the testing, so it's -- importantly, what we're seeing in both track and then in RET is obviously, lung cancer, we're seeing uptake of testing go rapidly.

就測試而言，重要的是，我們在軌道和 RET 中看到的顯然是肺癌，我們看到測試的迅速普及。

Our belief is that when we have good medicines, testing tends to follow pretty rapidly.

我們的信念是，當我們擁有好藥時，檢測往往會很快跟進。

And so it's important for us to accelerate bringing these medicines forward and then driving that testing quickly.

因此，我們必須加快推進這些藥物的研發，然後快速推動測試。

Key though, you're noting, success in these phases is getting testing to be widespread.

但是，您注意到，關鍵是這些階段的成功正在使測試變得廣泛。

So our focus is not just on long-term drug, but also partnering with pathologists and diagnostic laboratories and making sure that this testing is routine and available.

因此，我們的重點不僅僅是長期藥物，還與病理學家和診斷實驗室合作，確保這種測試是常規的和可用的。

We are seeing early adoption versus the academic central cancer centers and so we expect that will scale getting particularly NGS testing to be more routine.

我們看到早期採用與學術中心癌症中心相比，因此我們預計這將擴大規模，特別是 NGS 測試變得更加常規。

And again, we're seeing an increase in (inaudible) routine in lung, with the knowledge out there that there are opportunities in thyroid, we are seeing that testing go forward.

再一次，我們看到肺部（聽不清）常規增加，知道甲狀腺有機會，我們看到測試在繼續。

And I do believe that advances in testing will also bring the costs down.

而且我確實相信測試方面的進步也會降低成本。

That's also what we see as key.

這也是我們認為的關鍵。

So in our launch strategy, it's very much about the partnership between laboratories, the pathologists to make sure that they understand the value of testing.

因此，在我們的啟動策略中，實驗室和病理學家之間的合作關係非常重要，以確保他們了解測試的價值。

And I know that Bayer and Loxo agree with this as well.

我知道拜耳和 Loxo 也同意這一點。

So we believe that good medicines will drive change in practice, so we definitely are bringing forward good medicines.

所以我們相信好藥會推動實踐的改變，所以我們肯定會提出好藥。

We look forward to helping change the face of medicine, particularly in precision medicine, which is a high -- very high-value driver with the fact that with these very strong response rates, the efficiency of the health care system is significant.

我們期待幫助改變醫學的面貌，特別是在精準醫學方面，這是一個高價值的驅動因素，事實上，憑藉這些非常高的響應率，醫療保健系統的效率是顯著的。

Small numbers of patients, high response rates, a very efficient use of health care dollars.

患者人數少，反應率高，醫療保健費用的使用非常有效。

So we believe we can change that dynamic pretty rapidly.

所以我們相信我們可以很快改變這種動態。

And we'll go to Steve Scala with Cowen.

我們將與 Cowen 一起前往 Steve Scala。

Christi, may I clarify your comment on the baricitinib atopic dermatitis data?

克里斯蒂，我可以澄清一下您對巴瑞克替尼特應性皮炎數據的評論嗎？

There is only 1 primary endpoint in the trial, that's investigator global assessment.

試驗中只有 1 個主要終點，即研究者全局評估。

Is that the one that the 2 milligram missed?

那是2毫克漏掉的那個嗎？

Secondly, monarcHER and MONARCH plus are not listed in the key 2019 events, but both were expected.

其次，monarchHER 和 MONARCH plus 沒有列入 2019 年的重點事件，但兩者都在意料之中。

Can you clarify?

你能澄清一下嗎？

And then lastly, for Enrique, I hate to split hairs, but on the Q3 call, you referred to REWIND as paradigm changing on several occasions.

最後，對於 Enrique，我討厭分裂頭髮，但在 Q3 電話會議上，您多次將 REWIND 稱為範式改變。

You did not say that today, what has changed in the last 3 months?

你今天沒有說，最近3個月發生了什麼變化？

Thanks, Steve.

謝謝，史蒂夫。

We'll go to Christi for the first one on bari, then Anne for the MONARCH readout and then Enrique finally to close out on REWIND.

我們會去 Christi 看第一個 bari，然後 Anne 看 MONARCH 讀數，然後 Enrique 最後結束 REWIND。

Christi?

克里斯蒂?

Yes, so on the -- we had the primary endpoint and we had multiple secondary endpoints, and we're going to be sharing that data at a future scientific meeting, especially as we gain more knowledge with the next 3 studies that we'll read out this year.

是的，所以——我們有主要終點，我們有多個次要終點，我們將在未來的科學會議上分享這些數據，特別是當我們通過接下來的 3 項研究獲得更多知識時今年讀出。

There were multiple -- and we had -- a global assessment is a primary endpoint, but then we had multiple secondary endpoints to that, actually 8 of them.

有多個——我們有——全球評估是主要終點，但後來我們有多個次要終點，實際上是其中的 8 個。

And so as we know, the 4 milligram met all of the primary endpoints, as I said.

正如我們所知，正如我所說，4 毫克滿足了所有主要終點。

The 2 milligram missed on some of the secondary endpoints.

2 毫克錯過了一些次要終點。

So I appreciate you allowing me to clarify that answer.

所以我感謝你允許我澄清這個答案。

Anne?

安妮？

Yes.

是的。

On the monarcHER study, we do expect the readout to be in the first half of this year.

在 monarchHER 研究中，我們確實預計將在今年上半年公佈。

It is a Phase II study, so that's something that we wouldn't know necessarily on those listings.

這是一項 II 期研究，因此我們不一定會在這些列表中知道這一點。

But we do look forward to that readout and I look forward to the next stages of that, so whether we move forward to a Phase III study depending on the robustness of the data.

但我們確實期待該讀數，我期待下一階段，因此我們是否會根據數據的穩健性進行 III 期研究。

So you'll see that readout in the first half of this year.

所以你會在今年上半年看到這個讀數。

Thank you, Enrique?

謝謝你，恩里克？

My enthusiasm for REWIND and Trulicity have not changed at all.

我對 REWIND 和 Trulicity 的熱情絲毫沒有改變。

If anything, we're even more bullish today than we were maybe a couple of months back.

如果有的話，我們今天甚至比幾個月前更加樂觀。

And Mr. Hern, there are no further questions in queue.

Hern 先生，隊列中沒有其他問題。

Okay, great.

好，太棒了。

Thank you.

謝謝你。

We'll go to Dave for the close.

我們將去戴夫為結束。

Great.

偉大的。

Thank you, Kevin, and we appreciate your participation in today's earnings call and your interest in the company.

謝謝你，凱文，我們感謝你參加今天的財報電話會議以及你對公司的興趣。

We demonstrated again in 2018 clear progress toward our revenue and profitability goals for 2020.

我們在 2018 年再次展示了在實現 2020 年收入和盈利目標方面取得的明顯進展。

The company is executing well.

公司執行良好。

We continue to advance our innovation-based strategy through progressing internally discovered medicines augmented with business development transactions, highlighted by our recently announced acquisition of Loxo Oncology.

我們通過推進內部發現的藥物以及業務發展交易來繼續推進我們以創新為基礎的戰略，我們最近宣布收購 Loxo Oncology 就凸顯了這一點。

With a robust pipeline and volume-driven revenue growth, Lilly continues to be a compelling investment as we move into 2019.

憑藉強大的管道和銷量驅動的收入增長，禮來在進入 2019 年時將繼續成為一項引人注目的投資。

Thanks again for dialing in today.

再次感謝您今天撥入。

Please follow-up with our Investor Relations team if you have any additional questions we didn't address on the call, and hope you have a great day.

如果您有任何其他我們未在電話會議中解決的問題，請與我們的投資者關係團隊聯繫，並希望您度過愉快的一天。

Thank you.

謝謝你。

Ladies and gentlemen, that does conclude your conference.

女士們先生們，你們的會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連接。