禮來公司 (LLY) 2017 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Eli Lilly Q2 2017 Earnings Call.

女士們先生們，感謝您的支持，歡迎參加禮來公司 2017 年第二季度財報電話會議。

(Operator Instructions)

（操作員說明）

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

提醒一下，今天的電話正在錄音中。

I'll turn the conference now to Mr. Dave Ricks.

我現在將會議轉給 Dave Ricks 先生。

Please go ahead, sir.

請繼續，先生。

Thank you, and good morning.

謝謝你，早上好。

Thank you for joining us for Eli Lilly and Company's Second Quarter 2017 Earnings Call.

感謝您參加禮來公司 2017 年第二季度財報電話會議。

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

我是禮來公司董事長兼首席執行官戴夫·里克斯。

Joining me on today's call are Derica Rice, our Chief Financial Officer; Dr. Jan Lundberg, President of Lilly Research Labs; Enrique Conterno, President of Lilly Diabetes and Lilly U.S.A.; Dr. Sue Mahony, President of Lilly Oncology; Dr. Levi Garraway, Senior Vice President of Oncology, Global Development & Medical Affairs; Christi Shaw, President of Lilly Bio-Medicines; and Jeff Simmons, President of Elanco Animal Health.

今天和我一起參加電話會議的是我們的首席財務官德里卡·賴斯（Derica Rice）；禮來研究實驗室總裁 Jan Lundberg 博士； Enrique Conterno，禮來糖尿病和禮來美國公司總裁；禮來腫瘤學總裁 Sue Mahony 博士； Levi Garraway 博士，腫瘤學、全球發展和醫療事務高級副總裁；禮來生物醫藥總裁 Christi Shaw；和 Elanco Animal Health 總裁 Jeff Simmons。

We're also joined by Kristina Wright, Chris Ogden and Phil Johnson of our IR team.

我們的 IR 團隊的 Kristina Wright、Chris Ogden 和 Phil Johnson 也加入了我們的行列。

Today, we'll cover our usual quarterly content in an abbreviated form that will free up time for Sue and Levi to walk you through an update on our oncology strategy.

今天，我們將以簡短的形式介紹我們通常的季度內容，這將為 Sue 和 Levi 騰出時間來引導您了解我們的腫瘤學戰略的更新。

We believe the increased clarity and focus that is part of our revised strategy will make us more competitive in this key therapeutic area.

我們相信，作為我們修訂戰略一部分的更加清晰和專注將使我們在這一關鍵治療領域更具競爭力。

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 SEC.

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

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

我們提供的有關我們的產品和管道的信息是為了投資界的利益。

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

它不是為了促銷，也不足以做出處方決定。

I'll start by summarizing the quarter.

我將從總結本季度開始。

In Q2, we generated worldwide revenue growth of 8%, driven by volume growth in our new -- in our human pharmaceutical business, once again led by our new products.

在第二季度，我們的全球收入增長了 8%，這得益於我們新的人用藥物業務的銷量增長，再次由我們的新產品引領。

We also continued to expand our margins.

我們還繼續擴大我們的利潤。

Excluding the effect of FX on international inventory sold, gross margin as a percent of revenue increased by over 90 basis points and total operating expenses as a percent of revenue declined by over 390 basis points to 50.8%.

排除外匯對國際庫存銷售的影響，毛利率佔收入的百分比增加了 90 多個基點，總運營費用佔收入的百分比下降了 390 多個基點至 50.8%。

We continue to make progress with our pipeline.

我們繼續在管道方面取得進展。

Highlights include: the Japan approval for Olumiant for rheumatoid arthritis; the FDA granted Priority Review to abemaciclib in advanced breast cancer and Fast Track status to tanezumab for chronic OA and low back pain; we presented detailed data from our Phase III studies of galcanezumab for migraine prevention; and for abemaciclib, we presented detailed data from our Phase III MONARCH 2 study and announced initiation of a pivotal study in the adjuvant setting that has now begun.

亮點包括：日本批准 Olumiant 治療類風濕性關節炎； FDA 授予 abemaciclib 治療晚期乳腺癌的優先審評資格，授予 tanezumab 治療慢性 OA 和腰痛的快速通道資格；我們提供了 galcanezumab 預防偏頭痛的 III 期研究的詳細數據；對於 abemaciclib，我們提供了來自我們 III 期 MONARCH 2 研究的詳細數據，並宣佈在輔助設置中啟動一項關鍵研究，該研究現已開始。

In terms of capital deployment, just yesterday, we announced an alliance with Nektar Therapeutics to develop and commercialize NKTR-358, a novel immunological therapy for the potential treatment of a number of autoimmune and other chronic inflammatory conditions.

在資本部署方面，就在昨天，我們宣布與 Nektar Therapeutics 結盟，開發和商業化 NKTR-358，這是一種新型免疫療法，可用於治療多種自身免疫性疾病和其他慢性炎症性疾病。

We announced the collaboration with KeyBioscience on a potential new class of treatments for metabolic disorders, which closed earlier this month.

我們宣布與 KeyBioscience 合作開發一類潛在的代謝疾病新療法，該療法於本月初結束。

And we returned over $700 million to our shareholders through share repurchases and our dividend.

我們通過股票回購和股息向股東返還了超過 7 億美元。

In other news, we received an important ruling from the U.K. Supreme Court upholding our Alimta method-of-use patents in 4 major European countries.

在其他新聞中，我們收到了英國最高法院的一項重要裁決，支持我們在 4 個主要歐洲國家的 Alimta 使用方法專利。

And we also reached a settlement with generic companies that will provide exclusivity for Cialis until at least September 2018.

我們還與仿製藥公司達成和解，這些公司將至少在 2018 年 9 月之前為 Cialis 提供獨家經營權。

Our continued progress in 2017 keeps us on track to achieve our midterm goals with each of our strategic objectives.

我們在 2017 年繼續取得進展，使我們能夠通過每個戰略目標實現我們的中期目標。

Slides 5 and 6 contain more details on these events as well as other events of note that occurred since our April earnings call.

幻燈片 5 和 6 包含有關這些事件以及自 4 月財報電話會議以來發生的其他值得注意的事件的更多詳細信息。

I'd highlight that earlier this morning, we issued a press release to provide an update on our meeting with the FDA to discuss the baricitinib Complete Response Letter.

我要強調的是，今天早上早些時候，我們發布了一份新聞稿，以提供我們與 FDA 討論巴瑞替尼完整回复信的會議的最新情況。

The FDA has indicated that an additional clinical study is necessary for resubmission in order to further characterize the benefit/risk across doses in light of an observed imbalance in thromboembolic events that occurred during the placebo-controlled period of the RA clinical program.

FDA 表示，鑑於在 RA 臨床計劃的安慰劑對照期間觀察到的血栓栓塞事件不平衡，重新提交需要進行額外的臨床研究，以便進一步表徵不同劑量的益處/風險。

We disagree with the FDA's conclusions and believe the comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports baricitinib's approval as a new treatment option for people suffering from RA in the United States.

我們不同意 FDA 的結論，並認為綜合臨床數據表明存在積極的益處/風險特徵，支持巴瑞替尼被批准為美國 RA 患者的新治療選擇。

In the European Union, where baricitinib 2 milligrams and 4 milligrams have been approved since February of 2017, the CHMP recently agreed to update the label with a precaution for patients who have risk factors for DVT and PE.

在歐盟，自 2017 年 2 月以來已經批准了 2 毫克和 4 毫克的巴瑞替尼，CHMP 最近同意更新標籤，為有 DVT 和 PE 危險因素的患者提供預防措施。

In Japan, where baricitinib was also recently approved, the label includes a similar precaution.

在日本，巴瑞替尼最近也獲得了批准，標籤上也包含了類似的預防措施。

Along with Incyte, we're evaluating options for resubmitting, including further discussions with the FDA or conducting an additional clinical study.

與 Incyte 一起，我們正在評估重新提交的選項，包括與 FDA 的進一步討論或進行額外的臨床研究。

The time to resubmission will depend on which option we pursue, but is expected to be a minimum of 18 months.

重新提交的時間將取決於我們追求的選項，但預計至少需要 18 個月。

We are disappointed that resubmission will be delayed, but we are committed to bringing baricitinib to people with RA here in the U.S. We're also committed to a robust life cycle plan for baricitinib, as we see great potential in a number of other indications.

我們對重新提交將被延遲感到失望，但我們致力於將巴瑞克替尼帶給美國的 RA 患者。我們還致力於製定巴瑞克替尼的穩健生命週期計劃，因為我們看到了許多其他適應症的巨大潛力。

Moving to our financial results.

轉向我們的財務業績。

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 adjustment -- adjusted measures to provide insights into the underlying trends in our business.

我將把我的評論集中在我們的非公認會計原則調整上——調整後的措施，以提供對我們業務潛在趨勢的洞察。

So please refer to today's earnings press release for a detailed description of the year-on-year changes in our second quarter GAAP results.

因此，請參閱今天的收益新聞稿，詳細描述我們第二季度 GAAP 業績的同比變化。

Looking at the non-GAAP measures on Slide 9, you can see the revenue increase of 8% that I mentioned earlier.

查看幻燈片 9 上的非 GAAP 指標，您可以看到我之前提到的 8% 的收入增長。

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

毛利率佔收入的百分比增加到 76.7%。

This increase was driven by higher realized prices and manufacturing efficiencies, partially offset by the negative effect of product mix and higher expenses to support new pharmaceutical products.

這一增長是由較高的實際價格和製造效率推動的，但部分被產品組合的負面影響和支持新醫藥產品的更高費用所抵消。

Total operating expense was flat to Q2 2016, with marketing, selling and administrative expenses increasing 5% and R&D expenses decreasing 6%.

總運營費用與 2016 年第二季度持平，營銷、銷售和管理費用增長 5%，研發費用下降 6%。

The increase in marketing, selling and administrative expenses was driven by higher spending to support new product, partially offset by lower spending on later life cycle products.

營銷、銷售和管理費用的增加是由於支持新產品的支出增加，部分被後期生命週期產品的支出減少所抵消。

The decrease in R&D expenses was driven by a milestone payment in last year's quarter.

研發費用的減少是由去年季度的里程碑付款推動的。

Excluding this milestone payment, R&D expenses increased less than 2%.

不計這一里程碑付款，研發費用增長不到 2%。

Other income and expense was a $4 million expense this quarter compared to income of $20 million -- $21 million in last year's quarter.

本季度的其他收入和支出為 400 萬美元，而去年同期的收入為 2000 萬美元，即 2100 萬美元。

Our tax rate was 21.7%, a decrease of 70 basis points compared with the same quarter last year.

我們的稅率為21.7%，與去年同期相比下降了70個基點。

At the bottom line, net income increased 30% and earnings per share increased 29%.

歸根結底，淨收入增長了 30%，每股收益增長了 29%。

We achieved this significant earnings growth by delivering high single-digit, volume-based revenue growth while improving our gross margin percent and significantly reducing our OpEx ratio, creating positive leverage.

我們通過實現基於數量的高個位數收入增長，同時提高我們的毛利率並顯著降低我們的運營支出比率，創造了積極的槓桿作用，實現了這一顯著的收益增長。

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

幻燈片 10 詳細介紹了今年 6 月至今的相同非公認會計原則措施，而幻燈片 11 提供了報告和非公認會計原則每股收益之間的對賬。

You'll find additional details on these adjustments on Slides 35 and 36.

您可以在幻燈片 35 和 36 上找到有關這些調整的更多詳細信息。

Moving to Slide 12, let's take a look at the effects of price, rate and volume on revenue growth.

轉到幻燈片 12，讓我們來看看價格、費率和數量對收入增長的影響。

The effect of foreign exchange was minimal this quarter.

本季度外彙的影響微乎其微。

Excluding the slight headwind from FX, our worldwide revenue growth on a performance basis was 9% and was driven by volume, followed by price.

排除外匯帶來的輕微不利因素，我們的全球收入增長為 9%，主要受銷量驅動，其次是價格。

It's worth noting that in our human pharma business, each major geography drove volume growth this quarter.

值得注意的是，在我們的人類製藥業務中，每個主要地區都推動了本季度的銷量增長。

By geography, you'll notice that the U.S. pharmaceutical business increased 19%, driven by both price and volume.

從地理位置來看，您會注意到美國製藥業務在價格和數量的推動下增長了 19%。

Price growth was primarily driven by our late life cycle products, Cialis and Forteo, while Trulicity was the main driver of U.S. volume growth, with meaningful contributions also coming from Taltz, Basaglar, Jardiance and Lartruvo.

價格增長主要由我們的生命週期後期產品 Cialis 和 Forteo 推動，而 Trulicity 是美國銷量增長的主要推動力，Taltz、Basaglar、Jardiance 和 Lartruvo 也做出了有意義的貢獻。

Excluding FX, European pharma revenue growth was 4%, driven entirely by volume, despite significant headwinds on Alimta.

不包括外匯，歐洲製藥收入增長 4%，完全由銷量驅動，儘管 Alimta 面臨重大阻力。

Excluding Alimta, the rest of our European pharma revenue grew 10% on a performance basis, led by Trulicity.

除 Alimta 外，在 Trulicity 的帶領下，我們其餘的歐洲製藥收入在業績基礎上增長了 10%。

In Japan, despite a large negative impact from the entry of generic Zyprexa last June, pharma revenue increased 2%.

在日本，儘管去年 6 月仿製藥 Zyprexa 的進入造成了巨大的負面影響，但製藥收入增長了 2%。

Excluding Zyprexa, the rest of our Japan pharma revenue grew 16% in Q2, led by Cyramza, Cymbalta and Trulicity.

除 Zyprexa 外，我們在第二季度的其他日本製藥收入增長了 16%，其中 Cyramza、Cymbalta 和 Trulicity 領先。

Our pharma revenue in the rest of the world increased 3% on a performance basis this quarter.

本季度我們在世界其他地區的製藥收入增長了 3%。

Patent expirations for Cymbalta for several countries, including Canada, negatively affected ROW revenue growth.

包括加拿大在內的幾個國家的 Cymbalta 專利到期對 ROW 收入增長產生了負面影響。

Excluding Cymbalta, rest of world pharma revenue increased 7% in performance terms, led by Humalog, Trulicity and Humulin.

不包括 Cymbalta 在內，世界其他地區的製藥收入在業績方面增長了 7%，其中 Humalog、Trulicity 和 Humulin 領先。

Turning to animal health.

轉向動物健康。

Excluding the impact of FX, worldwide revenue decreased 8%, driven by volume, as price had a minimal impact.

剔除外彙的影響，由於價格的影響很小，全球收入在數量的推動下下降了 8%。

Food animal product revenue declined by 13% while companion animal product revenue increased 1%.

食用動物產品收入下降了 13%，而伴侶動物產品收入增長了 1%。

Animal health revenue benefited from the addition of BI's U.S. vaccine business, but revenue growth was negatively affected by buying patterns ahead of an SAP cutover that increased revenue in Q2 of last year by $40 million.

動物保健收入受益於 BI 的美國疫苗業務的增加，但收入增長受到 SAP 削減之前的購買模式的負面影響，去年第二季度的收入增加了 4000 萬美元。

On a performance basis, excluding the BI vaccine acquisition and adjusting for last year's purchasing patterns, our animal health revenue decreased 13%, with similar declines in both food and companion animals.

在業績基礎上，不包括 BI 疫苗的收購和對去年採購模式的調整，我們的動物保健收入下降了 13%，食品和伴侶動物的下降幅度相似。

The food animal decline was primarily driven by market access pressure as well as by competitive pressures in cattle and swine.

食用動物下降的主要原因是市場准入壓力以及牛和豬的競爭壓力。

The companion animal decline was primarily driven by competitive pressures in the parasiticides market.

伴侶動物的下降主要是由殺蟲劑市場的競爭壓力驅動的。

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

幻燈片 13 概述了我們 6 月份年初至今結果的相同信息。

As we've done in recent quarters, let's now take a look at the drivers of our worldwide volume growth on Slide 14.

正如我們在最近幾個季度所做的那樣，現在讓我們在幻燈片 14 上看一下我們全球銷量增長的驅動因素。

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

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

You can see these products drove 10.7 percentage points of volume growth.

您可以看到這些產品推動了 10.7 個百分點的銷量增長。

Lower Cialis volume provided a headwind of 120 basis points, primarily due to lower volume in the U.S. as a result of the decline in the overall ED market as well as increased use of off-label generic sildenafil, while lower animal health volume provided a headwind of 140 basis points.

較低的 Cialis 銷量帶來了 120 個基點的逆風，主要是由於整體 ED 市場下滑以及標籤外通用西地那非的使用增加導緻美國銷量下降，而較低的動物保健銷量則帶來了逆風140 個基點。

And the loss of exclusivity for Zyprexa, Cymbalta, Evista, Strattera and Axiron provided a drag of 280 basis points.

Zyprexa、Cymbalta、Evista、Strattera 和 Axiron 排他性的喪失拖累了 280 個基點。

Slide 15 provides a view of our new 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 $1 billion in revenue this quarter, with nearly half of that by Trulicity.

這些品牌本季度的總收入超過 10 億美元，其中近一半來自 Trulicity。

These products represented 18% of our total worldwide revenue in Q2, up from 15% just last quarter.

這些產品占我們第二季度全球總收入的 18%，高於上一季度的 15%。

Moving to Slide 16, you'll see that changes in foreign exchange rates had a small effect on our Q2 2017 results.

轉到幻燈片 16，您會看到外匯匯率的變化對我們 2017 年第二季度的業績影響很小。

Growth in non-GAAP EPS was 29%, including the effect of FX, and 32% in constant currency terms.

包括外匯影響在內的非公認會計原則每股收益增長 29%，按固定匯率計算增長 32%。

With that perspective on our Q2 financial results, I'll turn it over to Sue and Levi for an update on our oncology strategy

鑑於我們對第二季度財務業績的看法，我將把它交給 Sue 和 Levi，以了解我們的腫瘤學戰略的最新情況

Thank you, Dave.

謝謝你，戴夫。

As I mentioned during last quarter's earnings call Q&A, in the first half of this year, we took a fresh look at our oncology R&D strategy.

正如我在上個季度的財報電話問答中提到的那樣，今年上半年，我們重新審視了我們的腫瘤學研發戰略。

Having joined Lilly at the beginning of the year from Dana-Farber and Harvard, Levi played a key role in this review, providing a valuable new perspective, and we're pleased to have this opportunity today to share a summary of the output of our review.

Levi 在年初從 Dana-Farber 和哈佛加入禮來公司後，在這次審查中發揮了關鍵作用，提供了一個有價值的新視角，我們很高興今天有機會分享我們的成果摘要審查。

I'll start with an overview of the oncology trends that we felt we needed to address, and then I'll describe our R&D strategy at a high level.

我將從概述我們認為需要解決的腫瘤學趨勢開始，然後我將在高層次上描述我們的研發戰略。

And then I'll turn it over to Levi to delve into more detail.

然後我會把它交給 Levi 來深入研究更多細節。

As we all know, despite many exciting advances, there remains significant unmet need in oncology.

眾所周知，儘管取得了許多令人興奮的進展，但腫瘤學領域仍有大量未滿足的需求。

And many companies are pursuing this opportunity, and the field is becoming intensely competitive.

許多公司都在追逐這個機會，而該領域的競爭也越來越激烈。

And with the financial pressures payers are facing, the bar for innovation has increased.

隨著支付者面臨的財務壓力，創新的門檻也提高了。

We recognize that we must provide drugs that deliver larger increases in survival than we've traditionally seen in the past, and we are adapting our approach to respond to these trends in order to deliver greater innovation to patients.

我們認識到，我們必須提供能夠比我們過去看到的更大的生存率提高的藥物，我們正在調整我們的方法來應對這些趨勢，以便為患者提供更大的創新。

Moving to Slide 19, our strategy has 2 pillars.

轉到幻燈片 19，我們的戰略有兩個支柱。

The first is to build upon our key therapeutics that are already on the market or nearing the market and that have the potential to be foundational agents.

首先是建立在我們已經上市或即將上市並有可能成為基礎藥物的關鍵療法的基礎上。

The second is to pursue new standard of care-changing agents that create a very high bar.

二是追求新的換醫標準，創造了很高的標準。

And in a moment, Levi will outline how we'll assess such potential.

稍後，Levi 將概述我們將如何評估這種潛力。

On the second pillar, I would like to highlight that we intend to pursue breakthrough molecules across a variety of mechanisms, including but not limited to immuno-oncology.

在第二個支柱上，我想強調我們打算通過各種機制尋求突破性分子，包括但不限於免疫腫瘤學。

Key to our efforts will be leveraging advances in scientific understanding to identify targets with a strong biological rationale, and we will focus on targets that attack human dependencies or overcome resistance in reaching the target population to drive a larger benefit.

我們努力的關鍵將是利用科學認識的進步來確定具有強大生物學原理的目標，我們將專注於攻擊人類依賴性或克服接觸目標人群的阻力以帶來更大利益的目標。

Let me say a few words on the first pillar of our strategy, because we have a solid base on which to build.

讓我談談我們戰略的第一個支柱，因為我們有一個堅實的基礎可以建立。

In addition to Alimta and Erbitux, we have Cyramza, which is approved in 3 different tumor types and has become a standard of care in the treatment of gastric cancer, with particularly strong adoption in Japan.

除了 Alimta 和 Erbitux，我們還有 Cyramza，它被批准用於 3 種不同的腫瘤類型，並已成為治療胃癌的護理標準，在日本尤其被廣泛採用。

We hope to expand the use of Cyramza in gastric cancer to the first-line setting and to second-line urothelial cancer.

我們希望將 Cyramza 在胃癌中的應用擴大到一線環境和二線尿路上皮癌。

And we have Phase III trials that will read out this year and next to potentially expand Cyramza's indication into liver and first-line EGFR mutant lung cancers.

我們的 III 期試驗將在今年和明年公佈，可能會將 Cyramza 的適應症擴大到肝癌和一線 EGFR 突變肺癌。

In addition, we've seen promising early data on the combination of Cyramza with pembrolizumab in lung cancer, which represents an interesting area for additional study.

此外，我們已經看到了有關 Cyramza 與 pembrolizumab 聯合治療肺癌的有希望的早期數據，這代表了一個值得進一步研究的有趣領域。

Lartruvo is a monoclonal antibody that inhibits platelet-derived growth factor receptor alpha.

Lartruvo 是一種單克隆抗體，可抑制血小板衍生的生長因子受體 α。

Added to doxorubicin, Lartruvo is the first medicine in more than 4 decades shown to help patients with soft tissue sarcoma live longer when compared to doxorubicin alone, by 11.8 months, an 80% improvement.

在多柔比星的基礎上，Lartruvo 是 4 多年來第一個被證明可以幫助軟組織肉瘤患者比單獨使用多柔比星活得更長 11.8 個月的藥物，改善了 80%。

We hope to extend the use of Lartruvo across additional lines of therapy for sarcoma.

我們希望將 Lartruvo 的使用擴展到肉瘤的其他治療線。

And in addition, we are studying Lartruvo in other cancer types.

此外，我們正在研究其他癌症類型的 Lartruvo。

And lastly, abemaciclib is a selective inhibitor of cyclin-dependent kinases CDK 4 and CDK 6. Abemaciclib was purposely developed to be given on a continuous dosing schedule to induce tumor shrinkage.

最後，abemaciclib 是一種細胞週期蛋白依賴性激酶 CDK 4 和 CDK 6 的選擇性抑製劑。Abemaciclib 被特意開發為以連續給藥方案給藥以誘導腫瘤縮小。

We are encouraged by the single-agent activity we've seen in heavily pretreated patients across multiple tumor types and are pleased to have received Priority Review here in the U.S. for our NDA submission of the MONARCH 1 and MONARCH 2 data in metastatic ER-positive HER2- breast cancer, the last being in combination with fulvestrant.

我們對我們在多種腫瘤類型的大量預處理患者中看到的單藥活動感到鼓舞，並很高興在美國收到優先審查，因為我們在 NDA 提交的轉移性 ER 陽性的 MONARCH 1和 MONARCH 2數據HER2-乳腺癌，最後一種是與氟維司群聯合使用。

We also look forward to presenting interim results from the MONARCH 3 study of abemaciclib in combination with aromatase inhibitors as initial treatment in endocrine-sensitive breast cancer patients at ESMO in September.

我們還期待在 9 月的 ESMO 上展示 abemaciclib 聯合芳香酶抑製劑作為內分泌敏感乳腺癌患者初始治療的 MONARCH 3 研究的中期結果。

We continue to believe that abemaciclib could represent a potential best-in-class CDK 4 and 6 inhibitor based on the totality of the data, including magnitude and depth of response as well as progression-free survival, and that it will become an important new treatment option for patients with breast cancer.

我們仍然相信 abemaciclib 可能代表一種潛在的同類最佳 CDK 4 和 6 抑製劑，基於全部數據，包括反應的幅度和深度以及無進展生存期，並且它將成為一個重要的新乳腺癌患者的治療選擇。

We aim to establish a broad presence for abemaciclib in estrogen receptor-positive breast cancer, not only in HER2- but also in HER2+ disease.

我們的目標是在雌激素受體陽性乳腺癌中建立 abemaciclib 的廣泛存在，不僅在 HER2-而且在 HER2+ 疾病中。

And as Dave mentioned earlier, we recently announced initiation of a study in the adjuvant setting, which we see as a significant opportunity.

正如 Dave 之前提到的，我們最近宣佈在輔助環境中啟動一項研究，我們認為這是一個重要的機會。

Based on the biology of CDK 4, RAS-dependent tumors are also a priority, including our ongoing trial in KRAS mutation-positive non-small cell lung cancer.

基於 CDK 4 的生物學，RAS 依賴性腫瘤也是一個優先事項，包括我們正在進行的 KRAS 突變陽性非小細胞肺癌試驗。

Finally, we see multiple opportunities to combine abemaciclib with novel molecules to enhance efficacy and address resistance mechanisms.

最後，我們看到了將 abemaciclib 與新分子結合以提高療效和解決耐藥機制的多種機會。

These assets, along with Alimta and Erbitux, represent a strong base from which to grow our oncology business.

這些資產，連同 Alimta 和 Erbitux，代表了我們發展腫瘤業務的強大基礎。

Now I'll turn it over to Levi.

現在我把它交給李維。

Thanks, Sue.

謝謝，蘇。

First, let me emphasize how remarkable the opportunity is in oncology these days.

首先，讓我強調一下這些天在腫瘤學領域的機會是多麼顯著。

And it's particularly exciting here at Lilly Oncology R&D.

Lilly Oncology R&D 尤其令人興奮。

Our team has the track record, the capabilities and the passion to make a difference for cancer patients, and I'm confident we'll do so.

我們的團隊擁有為癌症患者帶來改變的往績、能力和熱情，我相信我們會這樣做。

Earlier, Sue pointed out that the competitive intensity in oncology requires that we raise the bar for clinical impact and innovation.

早些時候，Sue 指出，腫瘤學的競爭強度要求我們提高臨床影響和創新的標準。

I'll start by describing how we'll set that bar high in order to compete and win in this exciting field.

我將首先描述我們將如何設置高標準以便在這個激動人心的領域中競爭和獲勝。

Sue mentioned the term foundational agent.

蘇提到了基礎代理人這個詞。

As shown on the left side of Slide 21, we think of foundational agents as having certain important characteristics.

如幻燈片 21 左側所示，我們認為基礎代理具有某些重要特徵。

Principally, they inhibit a key dependency within the tumor.

主要是，它們抑制腫瘤內的關鍵依賴性。

That is, a target or pathway essential to the viability of the malignant cells themselves or their ability to fend off the immune system.

也就是說，對惡性細胞本身的生存能力或它們抵禦免疫系統的能力至關重要的靶點或途徑。

Ideally, we can enrich for such dependencies using genetic or molecular biomarkers.

理想情況下，我們可以使用遺傳或分子生物標誌物來豐富這種依賴關係。

But we must have strong evidence that the target is essential for the biology of the cancer cells.

但我們必須有強有力的證據表明該靶標對於癌細胞的生物學至關重要。

At the same time, we recognize that changing the standard of care in oncology usually requires combinations.

同時，我們認識到改變腫瘤學護理標准通常需要組合。

Such foundational regimens should be similarly rooted in biology, leading to rational combinations that drive meaningful clinical benefit in multiple malignancies.

這樣的基礎方案應該同樣植根於生物學，導致合理的組合，在多種惡性腫瘤中帶來有意義的臨床益處。

From a practical perspective, it becomes essential to employ rigorous and standardized criteria to determine whether a drug candidate could be a future foundational agent.

從實踐的角度來看，採用嚴格和標準化的標準來確定候選藥物是否可以成為未來的基礎藥物變得至關重要。

To accomplish this, we have developed a set of criteria that we can apply across the board to assets already in clinical development, assets we want to advance into the clinic and those we may want to bring in from the outside.

為了實現這一點，我們制定了一套標準，我們可以將這些標準全面應用於已經在臨床開發中的資產、我們想要進入臨床的資產以及我們可能想要從外部引進的資產。

First, we must have a clear hypothesis.

首先，我們必須有一個明確的假設。

What is the dependency we're attacking?

我們要攻擊的依賴是什麼？

And how do we know this dependency is operant?

我們怎麼知道這種依賴是可操作的？

Second, we need a clear path to enrich the relevant cancer patient population based on genetic or molecular criteria.

其次，我們需要一條明確的路徑來根據遺傳或分子標準豐富相關癌症患者群體。

This patient enrichment doesn't have to be perfect, but we need one or more biomarkers that tell us we're likely oversampling for patients in whom the dependency is operant during clinical development.

這種患者富集不一定是完美的，但我們需要一個或多個生物標誌物來告訴我們，我們可能對在臨床開發期間依賴操作的患者進行過採樣。

The biomarker discovery process really starts in the preclinical stages, well before we even begin testing the regimen in patients.

生物標誌物的發現過程真正開始於臨床前階段，甚至在我們開始在患者身上測試治療方案之前。

Third, we must optimize the treatment early in development.

三是要在開發早期優化治療。

How do we know we've hit the target hard enough?

我們怎麼知道我們已經足夠努力地擊中目標了？

Can we obtain serial biopsies to look at pharmacodynamics and assess the extent of target engagement or inhibition?

我們能否獲得連續活檢來觀察藥效學並評估靶標參與或抑制的程度？

How do we engineer a dosing regimen that minimizes off-target toxicities?

我們如何設計一種最大限度地減少脫靶毒性的給藥方案？

The fourth and fifth criteria address key clinical and commercial hurdles we have to clear.

第四個和第五個標準解決了我們必須清除的關鍵臨床和商業障礙。

Is it looking like we're headed for an incremental or a substantial clinical effect?

看起來我們正在走向增量或實質性的臨床效果嗎？

If it's the former, we either need a better patient enrichment strategy to drive a larger effect size, or we should stop developing.

如果是前者，我們要么需要更好的患者豐富策略來推動更大的效應量，要么我們應該停止開發。

And finally, we always need to ask ourselves, do we have an opportunity to win?

最後，我們總是需要問自己，我們有機會獲勝嗎？

Do we have a path to gain reasonable market share?

我們是否有途徑獲得合理的市場份額？

This is where being first-in-class or best-in-class comes into play.

這就是一流或一流的發揮作用的地方。

Given the environmental trends Sue mentioned, we expect that fewer assets will clear the high bar set through this decision framework.

鑑於 Sue 提到的環境趨勢，我們預計更少的資產將通過該決策框架設置高標準。

However, we should be in a position to drive those assets that do clear the bar more aggressively.

但是，我們應該能夠更積極地推動那些確實清除障礙的資產。

We simply can't afford to spread ourselves so thin that we lack the speed and focus required to accelerate potential breakthrough agents and regimens that do meet these criteria.

我們根本無法承受如此分散自己的負擔，以至於我們缺乏加速滿足這些標準的潛在突破性藥物和方案所需的速度和重點。

Now we've applied this decision framework to our current portfolio.

現在，我們已將此決策框架應用於我們當前的投資組合。

And as we did so, it became clear to us that there were a number of molecules that have the potential, depending on the clinical data, of course, to achieve the high bar we have set for standard of care-changing foundational assets.

當我們這樣做時，我們清楚地知道，根據臨床數據，當然有許多分子有潛力達到我們為改變護理標準的基礎資產設定的高標準。

You can see on Slide 22 that in addition to abemaciclib, which is under Priority Review at the FDA, we have identified 6 early- to mid-stage assets that potentially meet the decision criteria that I just outlined.

您可以在幻燈片 22 上看到，除了正在接受 FDA 優先審查的 abemaciclib 之外，我們還確定了 6 種可能符合我剛才概述的決策標準的早期至中期資產。

There are assets -- these are the assets where we're now focusing the vast majority of our internal R&D dollars.

有資產——這些是我們現在將絕大多數內部研發資金集中在這些資產上。

These include agents targeting CHK1, ERK 1 and 2, the TGF-beta receptor and TIM3.

這些包括靶向 CHK1、ERK 1 和 2、TGF-β 受體和 TIM3 的藥物。

I'll say more about these in a moment.

稍後我會詳細介紹這些內容。

You can see that we've also included our PD-L1 inhibitor and PI3-kinase/mTOR inhibitor, which we intend to use primarily in combinations that boost other marketed or promising portfolio assets.

您可以看到，我們還包括我們的 PD-L1 抑製劑和 PI3-激酶/mTOR 抑製劑，我們打算主要將其用於促進其他已上市或有前景的投資組合資產的組合。

Together, these assets have the potential to be foundational agents or to anchor foundational regimens.

總之，這些資產有可能成為基礎代理或錨定基礎方案。

We currently have 3 assets where we are awaiting data from ongoing trials before deciding if they will move into our priority internal pipeline, external partnership or out of our portfolio altogether.

我們目前有 3 項資產，我們正在等待正在進行的試驗的數據，然後再決定它們是否會進入我們的優先內部管道、外部合作夥伴關係或完全退出我們的投資組合。

For example, merestinib is a multi-kinase inhibitor currently in a registrational Phase II study, together with Cyramza, in biliary tract cancer.

例如，merestinib 是一種多激酶抑製劑，目前正在與 Cyramza 一起在膽道癌中進行註冊 II 期研究。

If this trial meets its primary endpoint, it will become a priority asset for future life cycle development, potentially across multiple indications.

如果該試驗達到其主要終點，它將成為未來生命週期開發的優先資產，可能跨越多個適應症。

If not, we may pursue external partnerships to develop merestinib.

如果沒有，我們可能會尋求外部合作夥伴來開發 Merestinib。

The CSF1R antibody is in exploratory clinical studies where the magnitude of efficacy [signal] will similarly dictate the path forward.

CSF1R 抗體處於探索性臨床研究中，其中療效 [信號] 的大小將同樣決定前進的道路。

For our AIM2 antibody, we are currently evaluating potential patient enrichment strategies that could guide its development.

對於我們的 AIM2 抗體，我們目前正在評估可能指導其發展的潛在患者富集策略。

Thus, we expect clarifying data to emerge for each of these assets over the next several months.

因此，我們預計在接下來的幾個月中，這些資產中的每一項都會出現明確的數據。

Finally, you'll see a number of assets where we've already engaged or will be seeking external partners to advance clinical development.

最後，您將看到我們已經參與或將尋求外部合作夥伴來推進臨床開發的一些資產。

In some cases, such as the CDC7 inhibitor, aurora kinase inhibitor and a novel CHK1 inhibitor, these assets are currently owned by third parties and Lilly retains rights to bring them back in-house if key milestones are met.

在某些情況下，例如 CDC7 抑製劑、極光激酶抑製劑和新型 CHK1 抑製劑，這些資產目前歸第三方所有，如果達到關鍵里程碑，禮來公司保留將其帶回內部的權利。

In most other cases, we remain excited about the quality of our compounds but believe that the optimal development path will be best implemented in partnership with external entities that have specific or niche biological expertise.

在大多數其他情況下，我們仍然對我們化合物的質量感到興奮，但相信最佳開發路徑將最好與具有特定或利基生物學專業知識的外部實體合作實施。

In the case of galunisertib, which inhibits the TGF-beta receptor, we have 2 ongoing studies in combination with immune checkpoint blockade.

就抑制 TGF-β 受體的 galunisertib 而言，我們正在進行 2 項與免疫檢查點阻斷相結合的研究。

The results of these studies will inform the development of our entire TGF-beta platform, which remains a priority focus.

這些研究的結果將為我們整個 TGF-beta 平台的開發提供信息，這仍然是一個優先重點。

By prioritizing our assets in this way, we are giving ourselves flexibility to bet more aggressively on portfolio assets with the highest foundational potential while derisking others externally, and importantly, making room to bring external innovation into our oncology portfolio.

通過以這種方式對我們的資產進行優先排序，我們可以靈活地更積極地押注具有最高基礎潛力的投資組合資產，同時在外部降低其他資產的風險，重要的是，為將外部創新引入我們的腫瘤學投資組合騰出空間。

And we will talk more about that later.

稍後我們將對此進行更多討論。

Now I'll highlight 3 of our priority internal assets briefly to illustrate why we are focusing in this way.

現在，我將簡要介紹我們的 3 項優先內部資產，以說明我們為何如此關注。

First, we have a highly selective ERK1/2 inhibitor in Phase I studies.

首先，我們在 I 期研究中有一種高度選擇性的 ERK1/2 抑製劑。

ERK is a key oncogenic driver in many cancers, including a large proportion of RAS mutant cancers, nearly all BRAF mutant cancers and many tumors driven by receptor tyrosine kinase aberrations.

ERK 是許多癌症的關鍵致癌驅動因素，包括大部分 RAS 突變癌症、幾乎所有 BRAF 突變癌症和許多由受體酪氨酸激酶異常驅動的腫瘤。

The upper left panel shows that the preclinical activity of our ERK inhibitor correlates strongly with alterations in the RAS pathway.

左上圖顯示我們的 ERK 抑製劑的臨床前活性與 RAS 通路的改變密切相關。

The lower left panels show that combinations of our ERK inhibitor with abemaciclib yield superior antitumor effects in KRAS mutant xenograft studies, including tumor regression.

左下圖顯示我們的 ERK 抑製劑與 abemaciclib 的組合在 KRAS 突變異種移植研究（包括腫瘤消退）中產生了卓越的抗腫瘤作用。

This molecule is currently in the fourth dose cohort of the ongoing Phase I trial, and we're encouraged by the early safety and PK/PD data.

該分子目前處於正在進行的 I 期試驗的第四劑量隊列中，我們對早期的安全性和 PK/PD 數據感到鼓舞。

Within the next year, we expect to both achieve our maximum tolerated dose and begin a series of combination studies with abemaciclib and other assets.

在接下來的一年內，我們希望既能達到我們的最大耐受劑量，又能開始一系列與 abemaciclib 和其他資產的聯合研究。

These studies will be conducted in tumor types where an ERK dependency is pertinent, such as KRAS mutant colorectal cancer, pancreas cancer, advanced lung cancer and others.

這些研究將在與 ERK 依賴性相關的腫瘤類型中進行，例如 KRAS 突變結直腸癌、胰腺癌、晚期肺癌等。

Next is prexasertib, a potent small molecule inhibitor of the CHK1 kinase.

接下來是 prexasertib，一種有效的 CHK1 激酶小分子抑製劑。

CHK1 has emerged as an interesting target in cancers with DNA repair defects or a so-called replicated stress phenotype.

CHK1 已成為具有 DNA 修復缺陷或所謂的複制應激表型的癌症的一個有趣靶標。

Prexasertib is a first-in-class agent, and the left panel shows that we have seen objective responses with prexasertib monotherapy in both platinum-sensitive and platinum-resistant ovarian cancer.

Prexasertib 是一流的藥物，左圖顯示我們已經看到 prexasertib 單藥治療鉑敏感和鉑耐藥卵巢癌的客觀反應。

We have a molecular enrichment plan in place to explore monotherapy use in ovarian cancer, and we see possibilities for prexasertib in other tumors as well.

我們制定了分子富集計劃來探索卵巢癌的單一療法，我們也看到了 prexasertib 在其他腫瘤中的可能性。

We look forward to continued development of prexasertib in ovarian and other cancer types.

我們期待在卵巢癌和其他癌症類型中繼續開發 prexasertib。

Moving to our TIM3 monoclonal antibody that just recently entered the clinic.

轉向我們剛剛進入臨床的 TIM3 單克隆抗體。

TIM3 is a PD-1-like immune checkpoint.

TIM3 是一個類似 PD-1 的免疫檢查點。

It resides on the surface of T cells and tends to be activated at later cells of effector T cell function than PD-1 in what are often called exhausted T cells.

它位於 T 細胞表面，在效應 T 細胞功能較晚的細胞中往往被激活，而 PD-1 在通常被稱為耗盡的 T 細胞中。

Targeting TIM3 may therefore help overcome resistance to PD-1 therapies and may also enhance PD-1 activity when used in combination.

因此，靶向 TIM3 可能有助於克服對 PD-1 療法的耐藥性，並且在聯合使用時還可能增強 PD-1 活性。

Our approach is to take our TIM3 antibody, which we believe may have a distinct inhibitory mechanism, and expedite its clinical evaluation.

我們的方法是採用我們認為可能具有獨特抑制機制的 TIM3 抗體，並加快其臨床評估。

This antibody will be developed as a combination with our PD-L1 antibody in patients whose cancers are no longer responsive to existing checkpoint-based immunotherapy regimen.

該抗體將與我們的 PD-L1 抗體聯合開發，用於癌症不再對現有基於檢查點的免疫治療方案有反應的患者。

Now TIM3 is just one of several IO assets in our pipeline.

現在，TIM3 只是我們管道中的幾個 IO 資產之一。

For example, we intend to speed development of 2 bispecific monoclonal antibodies designed against IO targets.

例如，我們打算加速開發針對 IO 目標設計的 2 種雙特異性單克隆抗體。

The promise of bispecifics is that you not only inhibit 2 targets present on distinct cell types within a single therapy, but you can also use the arms of the antibody to bring those 2 different cell types together, for example, a tumor cell and a cytotoxic T cell.

雙特異性的承諾是，您不僅可以在一次治療中抑制不同細胞類型上存在的 2 個靶標，而且您還可以使用抗體的臂將這兩種不同的細胞類型結合在一起，例如，腫瘤細胞和細胞毒性細胞T細胞。

And that potentially drives greater efficacy.

這可能會提高療效。

Together with our other preclinical IO assets and an active business development agenda, which Sue will now say more about, we believe that these R&D efforts will position us well to bring new value to patients in this exciting arena.

連同我們的其他臨床前 IO 資產和積極的業務發展議程，Sue 現在將對此進行更多說明，我們相信這些研發工作將使我們處於有利位置，在這個令人興奮的領域為患者帶來新的價值。

Thank you, Levi.

謝謝你，利威爾。

In addition to the opportunities in our pipeline and our strong research capabilities, we will actively look to the external market to help us bring the best innovation to patients.

除了我們管道中的機會和強大的研究能力外，我們將積極尋找外部市場，幫助我們為患者帶來最好的創新。

Over the last few years, we've undertaken a number of clinical partnerships and preclinical collaborations to build on our IO capabilities.

在過去幾年中，我們建立了許多臨床合作夥伴關係和臨床前合作，以增強我們的 IO 能力。

Moving forward, you will see us being more aggressive on the business development front, especially regarding early-phase and preclinical assets.

展望未來，您將看到我們在業務發展方面更加積極進取，尤其是在早期和臨床前資產方面。

Specifically, we will actively pursue assets that can combine rationally with our existing products, serve as new potential foundational agents and enable new IO breakthroughs.

具體而言，我們將積極尋求與現有產品合理結合的資產，作為新的潛在基礎代理，實現新的IO突破。

The good news is that there is a lot of external innovation in oncology, and we intend to be much more active in this space to ensure we have a competitive pipeline going forward.

好消息是腫瘤學領域有很多外部創新，我們打算在這個領域更加活躍，以確保我們有一個具有競爭力的管道向前發展。

So to conclude, we already have a solid base to build upon, with Alimta hopefully enjoying exclusivity in the U.S. out to 2022 and in Europe and Japan out to 2021, and with Erbitux, Cyramza, Lartruvo and soon, abemaciclib if approved.

總而言之，我們已經有了堅實的基礎，Alimta 有望在 2022 年之前在美國享受排他性，在歐洲和日本享受到 2021 年的排他性，如果獲得批准，還有 Erbitux、Cyramza、Lartruvo 和很快的 abemaciclib。

By rigorously employing the framework that Levi described earlier, we'll focus on innovation that can deliver meaningful improvements in survival, with a balance toward first-in-class and best-in-class assets.

通過嚴格採用 Levi 之前描述的框架，我們將專注於能夠帶來有意義的生存改善的創新，並在一流和一流資產之間取得平衡。

We'll maintain a competitive pipeline by accessing more external innovation, particularly at earlier stages of clinical development.

我們將通過獲得更多外部創新來保持競爭優勢，尤其是在臨床開發的早期階段。

We'll focus only on assets that meet the high bar that we described and move quickly to capitalize on promising early data.

我們將只關注符合我們描述的高標準的資產，並迅速採取行動以利用有希望的早期數據。

And finally, we'll invest more heavily behind the bets we do make to drive robust life cycle plans that maximize the value that patients and investors can derive from our innovation.

最後，我們將投入更多資金支持我們所做的賭注，以推動穩健的生命週期計劃，最大限度地提高患者和投資者從我們的創新中獲得的價值。

So again, we have a strong base to build from.

再說一次，我們有一個強大的基礎可以建立。

But we need to and we will make changes to be more competitive and to deliver innovation that is highly valued by patients and physicians.

但我們需要並且我們將做出改變以提高競爭力，並提供患者和醫生高度重視的創新。

This is a time of unprecedented growth and opportunity in oncology, and it's an exciting time to be at Lilly, where we have an opportunity to make major impacts on the lives of patients that suffer from the most deadly cancers.

這是腫瘤學前所未有的增長和機遇的時期，在禮來公司是一個激動人心的時刻，我們有機會對患有最致命癌症的患者的生活產生重大影響。

Levi and I will be happy to answer any questions that you may have during the Q&A session.

Levi 和我很樂意回答您在問答環節中可能遇到的任何問題。

But now I'll turn the call over to Derica for a review of our overall corporate pipeline, progress on our potential key events and an update on our financial guidance for 2017.

但現在我將把電話轉給 Derica，以審查我們的整體公司管道、我們潛在關鍵事件的進展以及我們 2017 年財務指導的更新。

Well, thanks, Sue.

好吧，謝謝，蘇。

Slide 28 shows our NME pipeline as of July 21.

幻燈片 28 顯示了截至 7 月 21 日我們的 NME 管道。

Similar to what Levi showed you for the oncology NME pipeline and similar to what we've been doing for our NILEX pipeline, this shows select NMEs, highlighting those on which we think investors should focus.

類似於 Levi 向您展示的腫瘤 NME 管道以及我們一直在為我們的 NILEX 管道所做的事情，這顯示了精選的 NME，突出了我們認為投資者應該關注的那些。

Should you want -- should you need or want it, our IR team can provide you a list of the additional clinical-stage assets in our portfolio that aren't shown in this view of select assets.

如果您需要 - 如果您需要或想要它，我們的 IR 團隊可以為您提供我們投資組合中未顯示在此選定資產視圖中的其他臨床階段資產的列表。

Positive movements since our last earnings call includes: the U.S. submission of abemaciclib for advanced breast cancer based on both MONARCH 1 and MONARCH 2; the movement of endocrine mimetic for diabetes into Phase II; and initiation of Phase I for molecules to treat cancer, diabetes and Alzheimer's disease; the addition of 2 assets from our recent collaboration with KeyBioscience; and termination of development of a Phase I asset.

自我們上次財報電話會議以來的積極進展包括：美國提交了基於 MONARCH 1 和 MONARCH 2 治療晚期乳腺癌的 abemaciclib；用於糖尿病的內分泌模擬物進入第二階段；啟動治療癌症、糖尿病和阿爾茨海默病的分子的第一階段；從我們最近與 KeyBioscience 的合作中增加了 2 項資產；和終止第一階段資產的開發。

Our select NILEX pipeline, as shown on Slide 29, reflects the initiation of the abemaciclib adjuvant breast cancer study.

如幻燈片 29 所示，我們選擇的 NILEX 管道反映了 abemaciclib 輔助乳腺癌研究的啟動。

Now turning to Slide 30.

現在轉到幻燈片 30。

You can see the considerable progress we've made on the key events we projected for 2017.

您可以看到我們在預測 2017 年的關鍵事件上取得了相當大的進展。

Dave already mentioned most of the key events that have occurred since our last earnings call, so I'll simply comment on 2 changes.

戴夫已經提到了自上次財報電話會議以來發生的大部分關鍵事件，所以我將簡單地評論兩個變化。

First, we now expect to begin the Phase III study for baricitinib in psoriatic arthritis next year.

首先，我們現在預計明年將開始巴瑞替尼治療銀屑病關節炎的 III 期研究。

Second, we've added a line in the Phase III internal readouts section for the final analysis of the RAINFALL study for ramucirumab in the first-line gastric cancer as we now expect that the event before the end of the year.

其次，我們在 III 期內部讀數部分添加了一行，用於對 RAINFALL 研究在一線胃癌中的 RAINFALL 研究進行最終分析，因為我們現在預計該事件將在今年年底之前完成。

Turning to our 2017 financial guidance on Slide 31.

轉向我們關於幻燈片 31 的 2017 年財務指導。

You'll see that we raised the range for revenue by $200 million, primarily due to the uptake trends we're seeing for our new pharmaceutical products that offset headwinds in our animal health business.

您會看到我們將收入範圍提高了 2 億美元，這主要是由於我們看到的新醫藥產品的吸收趨勢抵消了我們動物保健業務的逆風。

Moving to the gross margin percent, we've reduced our guidance by 1 percentage point due to the effect of foreign exchange movement.

轉向毛利率百分比，由於外匯變動的影響，我們將我們的指導降低了 1 個百分點。

On R&D expense, we've increased the range by $100 million with the major drivers being the CoLucid acquisition and our decision to start the abemaciclib adjuvant trial, which we've gotten up and running in record time.

在研發費用方面，我們將範圍增加了 1 億美元，主要驅動因素是收購 CoLucid 以及我們決定開始 abemaciclib 佐劑試驗，我們已經在創紀錄的時間內啟動並運行了該試驗。

We've decreased our GAAP tax rate and EPS, primarily to reflect the Nektar deal.

我們降低了 GAAP 稅率和每股收益，主要是為了反映 Nektar 交易。

Finally, we increased our non-GAAP EPS range by $0.05 to $4.10 to $4.20 per share.

最後，我們將非公認會計原則每股收益範圍提高了 0.05 美元至 4.10 美元至 4.20 美元。

And we reduced our estimate for full year capital expenditures by $100 million to reflect updated project timing.

我們將全年資本支出的估計減少了 1 億美元，以反映更新的項目時間安排。

Before we go to the Q&A session, let me briefly sum up.

在進入問答環節之前，讓我簡單總結一下。

We've had another strong quarter.

我們又經歷了一個強勁的季度。

Led by our new products, worldwide revenue grew 8%.

在我們的新產品的帶動下，全球收入增長了 8%。

By making disciplined investments in our business, we've leveraged that top line growth into 29% non-GAAP EPS growth or 32% growth when excluding FX.

通過對我們的業務進行有紀律的投資，我們將收入增長轉化為 29% 的非公認會計原則每股收益增長或 32% 的增長（不包括外匯）。

While we're disappointed with the delay of baricitinib here in the U.S., we continue to have strong momentum behind our innovation-based strategy.

雖然我們對巴瑞克替尼在美國的延遲感到失望，但我們在以創新為基礎的戰略背後繼續保持強勁勢頭。

Since our last earnings call, we received approval for Olumiant in Japan, we received Priority Review for abemaciclib and we bolstered our pipeline with the KeyBioscience deal.

自上次財報電話會議以來，我們在日本獲得了 Olumiant 的批准，我們獲得了 abemaciclib 的優先審查，我們通過 KeyBioscience 交易加強了我們的管道。

We also completed an important strategic review of oncology and are confident that execution of this more focused strategy will position us to make significant contributions in this important therapeutic area.

我們還完成了對腫瘤學的重要戰略審查，並相信執行這一更有針對性的戰略將使我們能夠在這一重要的治療領域做出重大貢獻。

Going forward, our management team will remain focused on launching new products with excellence, reloading our late-stage pipeline, driving increased productivity to expand our operating margins and investing in our core drivers of our business, talent, scientific capabilities and technology platforms, to ensure our future growth prospects.

展望未來，我們的管理團隊將繼續專注於推出卓越的新產品，重新加載我們的後期管道，提高生產力以擴大我們的營業利潤，並投資於我們的業務、人才、科學能力和技術平台的核心驅動力，以確保我們未來的增長前景。

This concludes our prepared remarks.

我們準備好的評論到此結束。

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

現在我將把電話轉給菲爾來主持問答環節

Great.

偉大的。

Thank you, Derica.

謝謝你，德麗卡。

We would like to take as many questions as possible from the callers on the line (Operator Instructions).

我們希望盡可能多地回答在線呼叫者的問題（操作員說明）。

Now, John, if you can please provide the instructions for the Q&A session, then we're ready for the first caller.

現在，約翰，如果您可以提供問答環節的說明，那麼我們已經為第一個來電者做好了準備。

(Operator Instructions) First, we go to the line of Chris Schott with JPMorgan.

（操作員說明）首先，我們去摩根大通的 Chris Schott。

Just 2 here.

這裡只有2個。

First, coming on baricitinib, can you just elaborate a little bit more on what a trial addressing DVT and PE would look like here?

首先，關於巴瑞克替尼，您能否詳細說明一下解決 DVT 和 PE 的試驗會是什麼樣子？

It seems like this would have to be either a very large or long-term study given the low event rate.

鑑於事件發生率低，這似乎必須是一項非常大型或長期的研究。

So along those lines, should we think about something significantly longer than an 18-month delay it could have for a new study with baricitinib?

因此，按照這些思路，我們是否應該考慮比巴瑞替尼的新研究延遲 18 個月要長得多的事情？

Second question for me is on diabetes.

我的第二個問題是關於糖尿病的。

Any initial look or commentary on the 2018 kind of access or pricing as we go through this contracting season?

在我們度過這個簽約季節時，對 2018 年的訪問或定價有什麼初步看法或評論嗎？

I guess if you're thinking about any major changes to either access or price.

我猜您是否正在考慮對訪問權限或價格進行任何重大更改。

I know you're not going to give 2018 guidance, but just kind of directionally, how should we think about the portfolios as we head into next year?

我知道你不會給出 2018 年的指導，但只是有方向性的，我們應該如何考慮明年的投資組合？

Great.

偉大的。

Thank you, Chris, for the questions.

謝謝你，克里斯，你的問題。

So Christi, we'll go to you for the first question on baricitinib, and over to you, Enrique, for the question on 2018 access for diabetes products.

所以克里斯蒂，我們會問你關於巴瑞克替尼的第一個問題，然後交給你，恩里克，問你關於 2018 年糖尿病產品准入的問題。

Christi?

克里斯蒂?

Thank you very much for the question.

非常感謝您的提問。

As you probably saw in the press release this morning, we remain very disappointed, especially for the many rheumatoid arthritis patients in the United States who don't have access to bari in spite of its access in other countries and regions.

正如您可能在今天上午的新聞稿中看到的那樣，我們仍然非常失望，特別是對於美國的許多類風濕關節炎患者，儘管巴里在其他國家和地區都可以使用，但他們卻無法使用。

In terms of the clinical trial and how long that will take, we know that in exploring all of our options, the minimum amount for resubmission will be 18 months.

關於臨床試驗以及需要多長時間，我們知道在探索我們所有的選擇時，重新提交的最短時間為 18 個月。

We don't yet have clarity with the FDA.

我們尚未與 FDA 明確。

That'll be discussions we have with them exactly what kind of trial will help define better the benefit/risk profile of baricitinib.

這將是我們與他們討論的究竟什麼樣的試驗將有助於更好地確定巴瑞替尼的益處/風險概況。

But we are committed to a path forward, working with the FDA on that.

但我們致力於一條前進的道路，與 FDA 合作。

And I'll summarize by saying, in the end, all of these patients who are living with rheumatoid arthritis, in spite of all of the great treatments that are available, continue to suffer.

最後，我將總結說，所有這些患有類風濕性關節炎的患者，儘管有所有可用的很好的治療方法，都繼續受苦。

And Americans deserve access to this treatment, and we will continue to pursue not only rheumatoid arthritis but other indications with bari.

美國人應該得到這種治療，我們不僅會繼續追求類風濕性關節炎，還會繼續追求 bari 的其他適應症。

Great.

偉大的。

Thank you, Christi.

謝謝你，克里斯蒂。

Enrique?

恩里克?

Chris, so we do have, as you're aware, good access when we look across our brands.

克里斯，正如您所知，當我們查看我們的品牌時，我們確實有很好的訪問權限。

And we have strong performance, which helps our competitive position as we look at 2018.

我們擁有強勁的表現，這有助於我們在 2018 年的競爭地位。

The negotiations at this stage are not finalized.

現階段的談判尚未敲定。

It will be premature for me to talk about it.

我現在談論它還為時過早。

Yes.

是的。

And Chris, we do typically allow the payers to actually make their announcements before we would comment on changes.

克里斯，我們通常允許付款人在我們對更改發表評論之前實際發佈公告。

I don't think we'll begin to hear any of those until August, September time frame, likely.

我認為我們可能會在 8 月、9 月的時間範圍內開始聽到這些消息。

John, if we can go to the next caller, please?

約翰，如果我們可以去找下一位來電者，好嗎？

And we'll go to Seamus Fernandez with Leerink.

我們將和 Leerink 一起去 Seamus Fernandez。

So just a couple here.

所以這裡只有一對。

In terms of the situation with baricitinib, you do mention other opportunities and indications.

就巴瑞克替尼的情況而言，您確實提到了其他機會和適應症。

I think about a year ago at your Analyst Day, you mentioned expectation for your atopic dermatitis study to wrap up with baricitinib.

我想大約一年前在您的分析師日，您提到希望您的特應性皮炎研究以巴瑞替尼結束。

We haven't seen those data yet.

我們還沒有看到這些數據。

Just wondering when we might see those data and if that is one of the indications that you're interested in pursuing.

只是想知道我們何時可以看到這些數據，以及這是否是您有興趣追求的跡象之一。

Just as a follow-up to that, given the DVT/PE dynamics, can you just help us understand if RA patients are uniquely at higher risk of DVT and PE, such that FDA would be a little bit more balanced when considering other indications?

作為對此的跟進，鑑於 DVT/PE 動態，您能否幫助我們了解 RA 患者是否具有更高的 DVT 和 PE 風險，以便 FDA 在考慮其他適應症時更加平衡？

And then just a final question.

然後是最後一個問題。

As we look at sort of the opportunity for leverage, I know this question continues to get asked of Dave on a repeated basis, but as we continue to look at the leverage opportunity in the operating expense line, just wanted to get a better sense of if this is still viewed as a purely sales-driven opportunity or if you can work to control costs.

當我們研究槓桿的機會時，我知道這個問題繼續被反復問到戴夫，但是當我們繼續研究運營費用線中的槓桿機會時，只是想更好地了解如果這仍然被視為純粹的銷售驅動機會，或者您是否可以努力控製成本。

And just wanted to say thanks, Derica, for all of your efforts over the years.

只是想說謝謝，Derica，感謝你多年來所做的所有努力。

It's been a real pleasure.

這真是一種享受。

Great.

偉大的。

Seamus, thank you for the questions.

Seamus，謝謝你的提問。

Christi, we'll go to you for the first 2 on baricitinib.

克里斯蒂，我們將在前 2 次使用巴瑞替尼治療您。

Derica, if you want to comment on the third one.

德里卡，如果你想評論第三個。

Obviously, Dave, feel free to chime in.

顯然，戴夫，請隨意插話。

Christi?

克里斯蒂?

Sure.

當然。

Thank you for the questions, Seamus.

謝謝你的問題，Seamus。

We are pursuing other indications and continuing our studies in atopic dermatitis as well as lupus.

我們正在尋求其他適應症並繼續我們在特應性皮炎和狼瘡方面的研究。

And we also are going to begin the psoriatic arthritis trials next year.

我們也將在明年開始銀屑病關節炎試驗。

In specific terms of atopic dermatitis, the Phase II data you will see presented at a scientific forum before the end of the year.

就特應性皮炎而言，您將在年底前在科學論壇上看到的 II 期數據。

And then in terms of DVT and PE, yes, there was one placebo-controlled trial in the RA study that showed an imbalance of DVTs versus placebo.

然後就 DVT 和 PE 而言，是的，RA 研究中有一項安慰劑對照試驗顯示 DVT 與安慰劑的不平衡。

The overall rate -- if you look at the phase -- multiple Phase III trials in 3,000 patients, the overall rate of DVTs on patients treated with baricitinib was the same as what is published in patients on the overall background rate in rheumatoid arthritis in general.

總體比率——如果你看一下階段——在 3,000 名患者中進行的多項 III 期試驗，接受巴瑞替尼治療的患者的 DVT 總體發生率與在患者中公佈的關於類風濕性關節炎總體背景發生率的總體發生率相同.

So hopefully, that answers your questions and gives you rationale as to why we disagree with the FDA and why we feel very positive about pursuing other indications with baricitinib and continuing to find a path forward in RA with the FDA.

因此，希望這能回答您的問題，並為您解釋我們為什麼不同意 FDA 以及為什麼我們對使用 baricitinib 尋求其他適應症並繼續與 FDA 一起尋找 RA 的前進道路感到非常積極的理由。

Thank you, Christi.

謝謝你，克里斯蒂。

Derica?

德麗卡？

Thanks for your questions, Seamus, and for your comment.

感謝您的問題，Seamus，以及您的評論。

In regards to our margin goals, as we stated, 50% was the goal for '18.

關於我們的利潤目標，正如我們所說，50% 是 18 年的目標。

We think we'll go beyond that as we think about the remainder of the decade and beyond.

我們認為，在考慮這十年及以後的剩餘時間時，我們將超越這一點。

In regards to how we get there, it's both.

至於我們如何到達那裡，兩者兼而有之。

It is attributed to us driving a strong revenue growth profile that you've seen here for the first 6 months of the year, 8% in Q2 alone.

這歸功於我們推動了今年前 6 個月的強勁收入增長，僅在第二季度就增長了 8%。

But it's also contingent on us continuing to drive a very deliberate productivity and cost containment agenda inside Lilly.

但這也取決於我們是否繼續在禮來公司內部推動非常審慎的生產力和成本控制議程。

So when you look at our margins, if you look at just gross margin, you'll see over 90 basis points of improvement.

因此，當您查看我們的利潤率時，如果您只看毛利率，您會看到超過 90 個基點的改善。

That was a combination of prices but also manufacturing efficiencies, and we saw that in Q1.

這是價格和製造效率的結合，我們在第一季度看到了這一點。

And if you look at our OpEx, we improved our OpEx ratio by over 390 basis points alone in just the Q2.

如果您查看我們的運營支出，僅在第二季度，我們的運營支出比率就提高了 390 多個基點。

So you will continue to see us executing on both profiles, launching with excellence, but then, yes, also driving a very deliberate cost containment and productivity agenda inside Lilly going forward.

因此，您將繼續看到我們在這兩種情況下執行，以卓越的方式推出，但是，是的，還會在禮來公司內部推動非常慎重的成本控制和生產力議程。

And Seamus, just to put a little bit of numbers on your prior question, to our knowledge, the published rates of DVT and PE for patients with RA do range from approximately 0.3 to 0.8 per 100 patient years, and the rate reported for all RA patients receiving baricitinib during our development program was 0.46 per 100 patient years.

Seamus，只是在您之前的問題上放一點數字，據我們所知，公佈的 RA 患者 DVT 和 PE 的發生率確實在每 100 患者年大約 0.3 到 0.8 之間，並且報告的所有 RA 的發生率在我們的開發計劃期間接受巴瑞替尼的患者為每 100 患者年 0.46 人。

John, if we can go to the next caller, please?

約翰，如果我們可以去找下一位來電者，好嗎？

And that will be John Boris with SunTrust.

那將是 SunTrust 的 John Boris。

So question for Dave on the pricing front.

所以在定價方面向戴夫提問。

So obviously, there continues to be some bantering that continues on the pricing front, but the industry has done a relatively good job to shift that to discussing certainly high coinsurance, high deductibles.

顯然，在定價方面繼續存在一些玩笑，但該行業在將其轉移到討論高共同保險、高免賠額方面做得相對較好。

It seems as though Lilly does give up a significant portion as a pass-through on rebates.

似乎禮來公司確實放棄了很大一部分作為回扣的傳遞。

How can the industry help to shed additional light on that 50%, I think that Lilly gives back in terms of rebates, to give that back to customers for coinsurance penalty in plans?

行業如何幫助進一步了解這 50%，我認為禮來公司在回扣方面給予回饋，將其回饋給客戶在計劃中的共同保險罰款？

Is there any thought about how you could do that through contracting with PBMs going forward to get better control over where that's going?

有沒有想過如何通過與 PBM 簽訂合同來更好地控制未來的發展方向？

A second question, just for Levi.

第二個問題，只針對李維。

I really appreciate the internal review that you gave, but when you look externally and if you had a wish list, are there certain things that you don't have within your portfolio that might be at the top of the list that you would like to bring into Lilly's oncology portfolio?

我非常感謝您提供的內部審查，但是當您從外部查看並且如果您有願望清單時，您的投資組合中是否有某些東西可能位於您想要的清單頂部加入禮來（Lilly）的腫瘤學產品組合？

Great, John.

太好了，約翰。

Thank you for the questions.

謝謝你的提問。

Pretty straightforward.

很簡單。

Dave, for the first one.

戴夫，第一個。

And then over to you, Levi, for your wish list on your external innovation.

然後交給你，Levi，你的外部創新願望清單。

Dave?

戴夫？

Yes, thanks, John.

是的，謝謝，約翰。

On the pricing debate in the U.S., of course, the battle will never be over.

當然，在美國的定價辯論中，戰鬥永遠不會結束。

I think we need to continue to explain the value proposition we offer and defend the business model.

我認為我們需要繼續解釋我們提供的價值主張並捍衛商業模式。

But I agree with you.

但我同意你的看法。

We have staved off, I think, some of the worst ideas and continue to remain focused in Washington and in states on advocating versus -- for strategies that can actually bring down out-of-pocket costs for consumers.

我認為，我們已經避免了一些最糟糕的想法，並繼續在華盛頓和各州專注於倡導與 - 尋求實際上可以降低消費者自付費用的策略。

As you point out, we published earlier this year that 50% of our list price is discounted on average, and patients rarely receive any of that benefit at the pharmacy counter.

正如您所指出的，我們今年早些時候發布了我們標價的 50% 的平均折扣，患者很少在藥房櫃檯獲得任何優惠。

One big lever we've advocated for aggressively, along with our pharma colleagues, is through the Part D program, passing through rebates in the doughnut hole in some form.

我們與我們的製藥同事一起積極倡導的一個重要槓桿是通過 D 部分計劃，以某種形式通過甜甜圈洞中的回扣。

That's still on the table.

這仍然在桌面上。

In commercial plans, we do see growing interest in the same idea from large employers.

在商業計劃中，我們確實看到大型雇主對同樣的想法越來越感興趣。

And if you look at the absolute inflation rate of net pricing in medications versus the out-of-pocket costs for patients, they're not close.

如果你看一下藥物淨定價的絕對通貨膨脹率與患者的自付費用，它們並不接近。

Patient out-of-pocket costs are accelerating rapidly.

患者的自付費用正在迅速增加。

Finally, I'd say we've been a leader in prodding the system, if you would, through programs that work outside of insurance, both through Express Scripts in this case, but I see other PBMs active in the space, of providing a discount program that works outside the insurance system and provides PBM-like rebates directly to patients.

最後，我想說我們一直是推動系統的領導者，如果你願意的話，通過在保險之外工作的程序，在這種情況下都是通過 Express Scripts，但我看到其他 PBM 在該領域活躍，提供一個在保險系統之外運作並直接向患者提供類似 PBM 的回扣的折扣計劃。

We've done this in our insulin business with Link Health and more recently with a direct ESI program.

我們已經通過 Link Health 和最近的直接 ESI 計劃在我們的胰島素業務中做到了這一點。

We'll continue to do that to point out that the net pricing is not something patients enjoy.

我們將繼續這樣做，以指出淨定價不是患者喜歡的東西。

But I don't expect this to go away overnight, and we remain focused on it, John, to reduce that long-term risk to the business.

但我預計這不會在一夜之間消失，我們仍然專注於它，約翰，以減少對業務的長期風險。

Thanks, Dave.

謝謝，戴夫。

Levi?

利威爾？

Well, thanks for the question.

嗯，謝謝你的問題。

So as you point out, one of the most exciting areas of oncology has been just the amount of innovation that exists across the arena.

正如您所指出的，腫瘤學最令人興奮的領域之一就是整個領域存在的大量創新。

And here at Lilly, Dave, has really been pushing the idea of being more active in terms of bringing in external innovation.

在禮來公司，戴夫一直在推動更積極地引入外部創新的想法。

So we're very pleased for that prioritization here within Lilly.

因此，我們對禮來公司內部的優先順序感到非常高興。

To your specific question about a wish list, we don't look at this at an asset-by-asset level, but rather, we think about what can boost our strategies.

對於您關於願望清單的具體問題，我們不會逐個資產地看待這個問題，而是會考慮什麼可以提升我們的策略。

So what could be brought in that might combine well with some of our promising products?

那麼可以帶來什麼與我們的一些有前途的產品很好地結合呢？

And just in general, what are some areas scientifically where it's been obvious that advances have been made and where, if we could leverage what we do well at Lilly in terms of clinical development, we could add value there?

總的來說，在哪些科學領域取得了明顯的進步，如果我們可以利用禮來在臨床開發方面的優勢，我們可以在哪些領域增加價值？

So I would say it's not really an asset-by-asset basis, it's really about letting the science drive strategy.

所以我想說這並不是真正的逐項資產，而是讓科學驅動戰略。

And certainly, that would cover the gambit of both target therapy and immunotherapy advances.

當然，這將涵蓋靶向治療和免疫治療進展的策略。

Thanks, Levi.

謝謝，列維。

John, if we could go to the next caller, please?

約翰，如果我們可以去找下一位來電者，好嗎？

We'll go to Tim Anderson with Bernstein.

我們將和伯恩斯坦一起去蒂姆安德森。

A couple of questions.

幾個問題。

On abemaciclib, you describe this as one of your foundational assets, and later this year, you'll present MONARCH 3. Do you think that once those results are presented, the general takeaway from analysts and from oncologists is going to be that abema is clearly better than palbociclib when it -- when one does their side-by-side comparisons?

在 abemaciclib 上，您將其描述為您的基礎資產之一，今年晚些時候，您將展示 MONARCH 3。您是否認為一旦展示了這些結果，分析師和腫瘤學家的普遍看法將是 abema 是顯然比 palbociclib 更好 - 當他們進行並排比較時？

Thus far, despite Lilly's claims of differentiation, there's not a lot of people that are convinced that it's truly a best-in-class product.

到目前為止，儘管禮來公司聲稱其差異化，但並沒有很多人相信它確實是一流的產品。

Second question is on Alimta and the timing of the ruling for the IPR.

第二個問題是關於 Alimta 和知識產權裁決的時間。

In the past, Lilly was willing to give a time line because the rules for this sort of thing are pretty clear.

過去，禮來願意給出一個時間表，因為這種事情的規則很明確。

Most recently, you've backed away from providing a time line.

最近，您不再提供時間線。

And I'm wondering why the uncertainty this time around?

我想知道為什麼這次出現不確定性？

And what can we expect in terms of a time line, if you have any updates?

如果您有任何更新，我們可以在時間表方面期待什麼？

Great, Tim, thank you for the questions.

太好了，蒂姆，謝謝你的提問。

I think, Sue, those are both for you.

我想，蘇，這兩個都是給你的。

Yes, Tim, thanks very much here.

是的，蒂姆，在這裡非常感謝。

We -- well, firstly, on abema, we're delighted that we have the Priority Review for MONARCH 1 and MONARCH 2, and we anticipate getting action on those Q1 of next year.

我們 - 首先，在 abema 上，我們很高興我們對 MONARCH 1 和 MONARCH 2 進行了優先審查，我們預計明年第一季度會採取行動。

With regards to MONARCH 3, we're presenting it at ESMO.

關於 MONARCH 3，我們將在 ESMO 上展示它。

I think we've been pretty clear all the way through, Tim, that we do believe that we've got a differentiated medicine here, and one that potentially could be best-in-class.

我認為我們一直很清楚，蒂姆，我們確實相信我們這裡有一種差異化的藥物，並且可能是同類最佳的藥物。

We've got to look across all of the data to assess that, across the different clinical data and looking at PFS, response rate, et cetera, and across different trials.

我們必須查看所有數據以評估這一點，跨不同的臨床數據並查看 PFS、反應率等，以及跨不同的試驗。

And we've now got the MONARCH 1 data that shows single-agent activity; the MONARCH 2 data, which was in an endocrine-resistant patient population, a very homogeneous patient population, where we, to the best of our knowledge, have seen the highest PFS in any trial to date in that population; and of course, we'll see the MONARCH 3 later this year.

我們現在得到了顯示單代理活動的 MONARCH 1 數據； MONARCH 2 數據是針對內分泌耐藥患者群體，這是一個非常同質的患者群體，據我們所知，在該群體中，我們在迄今為止的任何試驗中都看到了最高的 PFS；當然，我們會在今年晚些時候看到 MONARCH 3。

So we continue to be very excited by this molecule.

所以我們繼續對這種分子感到非常興奮。

But I would continue to encourage you to look across all the data and all the trials as we assess this medicine.

但我會繼續鼓勵您在評估這種藥物時查看所有數據和所有試驗。

With regards to the Alimta IPR, we are now anticipating that we should get a reading on the IPR by the end of this year.

關於 Alimta IPR，我們現在預計我們應該在今年年底之前獲得有關 IPR 的信息。

That's the latest that we know, okay?

這是我們所知道的最新消息，好嗎？

And if we know any more, we'll let you know.

如果我們知道更多，我們會讓你知道。

But that's our understanding.

但這是我們的理解。

Great.

偉大的。

Thank you, Sue.

謝謝你，蘇。

John, if we can go to the next caller, please?

約翰，如果我們可以去找下一位來電者，好嗎？

We'll go to the line of Andrew Baum with Citi.

我們將與花旗一起前往安德魯鮑姆的路線。

A couple of questions, please.

有幾個問題，請。

The obvious bedfellow for prexasertib, given the mechanism and the lack of overlapping tox would be a PARP inhibitor.

prexasertib 的明顯夥伴，考慮到機制和缺乏重疊毒性，將是 PARP 抑製劑。

So what's your appetite for larger later biotech deals around, in your own words, a potentially foundational drug in the form of a PARP?

那麼，用你自己的話來說，你對後來更大的生物技術交易有什麼興趣，那就是一種潛在的 PARP 形式的基礎藥物？

Second, for Levi.

第二，對於李維斯。

How does your TIM3 differentiate itself from Novartis?

您的 TIM3 如何與諾華區別開來？

I think both target occipital steering, if I read your slides correctly.

如果我正確閱讀了您的幻燈片，我認為兩者都針對枕骨轉向。

And then finally, on the outlook statement in relation to animal health, could you break down for us how much of the competitive pressures, markets slowing, that you're seeing is market specific versus Lilly portfolio specific?

最後，關於與動物健康相關的展望聲明，您能否為我們分解一下，您所看到的競爭壓力和市場放緩有多少是特定於市場的，而不是特定於禮來（Lilly）的投資組合？

Andrew, thank you for the questions.

安德魯，謝謝你的問題。

So Dave, we'll go to you for the appetite for large, later-stage biotech deals.

所以戴夫，我們會去找你對大型後期生物技術交易的胃口。

On to Levi for the question on TIM3.

關於 TIM3 的問題，請聯繫 Levi。

And then, Jeff, over to you for the drivers in animal health.

然後，傑夫，請向您介紹動物健康方面的驅動因素。

Dave?

戴夫？

Yes, thanks, Andrew.

是的，謝謝，安德魯。

Not commenting specifically on the PARP inhibitor idea, I believe Levi could chime in on that.

沒有具體評論 PARP 抑製劑的想法，我相信 Levi 可以對此發表意見。

But the frame we have on M&A and business development isn't necessarily limited by size but rather by logic, which is we're interested in things that add to our portfolio where we can create new value for patients in the health care system, maybe through combinations or through individual assets.

但我們在併購和業務發展方面的框架不一定受規模限制，而是受邏輯限制，這就是我們對增加我們投資組合的東西感興趣，我們可以為醫療保健系統中的患者創造新價值，也許通過組合或通過單個資產。

We're not interested in business combinations that create a short-term cost synergy.

我們對產生短期成本協同效應的業務組合不感興趣。

We've said in the past that those are -- those would include small and midsized M&A.

我們過去曾說過，這些將包括中小型併購。

And so in that regard, I guess your question is would that -- would we rule out M&A, small and midsized?

所以在這方面，我想你的問題是——我們會排除併購，中小型企業嗎？

No, we wouldn't.

不，我們不會。

If it made sense on the first basis, which is adding to our portfolio in a way that creates new value for the health care system.

如果它在第一個基礎上有意義，那就是以一種為醫療保健系統創造新價值的方式增加我們的投資組合。

Great.

偉大的。

Thanks, Dave.

謝謝，戴夫。

Levi?

利威爾？

Yes, just adding on prexasertib, I would agree with Dave.

是的，只要加上 prexasertib，我就同意 Dave。

And certainly, your point about a PARP inhibitor as a potential combination is interesting, but there are actually several potential interesting combinations that we're pursuing with prexasertib.

當然，您關於 PARP 抑製劑作為潛在組合的觀點很有趣，但實際上我們正在使用 prexasertib 尋求幾種潛在的有趣組合。

So what we -- we think about this, as Dave mentioned, sort of in the totality of what the science [affords] as opposed to a particular deal or exchange.

所以我們 - 正如戴夫所提到的那樣，我們對此的看法是科學[提供]的整體，而不是特定的交易或交換。

With regard to TIM3, our preclinical evidence suggests that our TIM3 molecule has a distinct mechanism of TIM3 inhibition, as than some of the competitor molecules.

關於 TIM3，我們的臨床前證據表明，與某些競爭分子相比，我們的 TIM3 分子具有獨特的 TIM3 抑制機制。

And this could be of potential importance because unlike, for example, PD-1, where the relevant ligands are well understood in terms of the reason why a TIM -- an anti-PD-1 works in cancer immunotherapy, there are actually several ligands for TIM3, and the relative contributions of those ligands in the tumor immunology context is less clear.

這可能具有潛在的重要性，因為與例如 PD-1 不同，相關配體在 TIM（抗 PD-1 抗 PD-1 在癌症免疫治療中起作用）的原因方面得到了很好的理解，實際上有幾種配體對於 TIM3，這些配體在腫瘤免疫學背景下的相對貢獻尚不清楚。

So obviously, it's early days.

很明顯，現在還為時過早。

We'll need to await clinical activity to determine whether that's a clinical distinction.

我們需要等待臨床活動來確定這是否是臨床區別。

But preclinically, that does appear to be a potentially important difference.

但在臨床前，這似乎是一個潛在的重要差異。

Thank you, Levi.

謝謝你，利威爾。

Jeff?

傑夫?

Yes, Andrew, I think I'll just put in broader context the animal health situation and then I'll answer the mix versus the market or portfolio.

是的，安德魯，我想我將把動物健康狀況放在更廣泛的背景下，然後我會回答混合與市場或投資組合。

As we signaled earlier this year, we did expect Q2 to be a challenging quarter.

正如我們今年早些時候所暗示的那樣，我們確實預計第二季度將是一個充滿挑戰的季度。

Part of this was due to the higher buy-in a year ago with the SAP cutover.

部分原因是一年前通過 SAP 轉換獲得了更高的支持。

But there are really 3 issues that Dave mentioned in his comments that have impacted our Q2 results in animal health: one, competitive pressures in companion animal parasiticides; two, market access in food animal that is portfolio driven; and competitive pressures in cattle.

但戴夫在評論中確實提到了 3 個問題，這些問題影響了我們第二季度在動物健康方面的業績：一，伴侶動物殺蟲劑的競爭壓力；二是投資組合驅動的食用動物市場准入；和牛的競爭壓力。

So on the first issue, just real quickly, on the competitive pressures in companion animal parasiticides, we continue to see new entrants.

所以在第一個問題上，很快，關於伴侶動物寄生蟲劑的競爭壓力，我們繼續看到新的進入者。

We continue to see this space become more crowded.

我們繼續看到這個空間變得更加擁擠。

However, we do see positives for us in our companion animal business, and I'll touch on 2. Galliprant, our deal with Aratana, that growth is meeting expectations.

但是，我們確實在伴侶動物業務中看到了積極的一面，我將談到 2。Galliprant，我們與 Aratana 的交易，增長符合預期。

And then our BI vaccine portfolio, that is also on track with our expectations.

然後是我們的 BI 疫苗組合，這也符合我們的預期。

As you move to market access, this is where there's a portfolio factor.

當您轉向市場准入時，這就是投資組合因素。

Posilac, and this is mainly the big driver here in Q2, or rbST, it's a productivity product in the dairy market, we have seen U.S. customers chosen to forego the benefits of this with the oversupply of milk and lower prices.

Posilac，這主要是第二季度的主要驅動力，或 rbST，它是乳製品市場的生產力產品，我們已經看到美國客戶選擇放棄它的好處，因為牛奶供應過剩和價格下降。

We've seen kind of the clean food label movement.

我們已經看到了清潔食品標籤運動。

And then you combine this with the unfavorable economics in dairy.

然後你把它與乳製品的不利經濟結合起來。

And then I think the last issue is just food animal competition, primarily in U.S. beef, and this has just increased bundling activity and more aggressive pricing.

然後我認為最後一個問題只是食用動物競爭，主要是美國牛肉，這只是增加了捆綁活動和更激進的定價。

That's some market driven but as well portfolio.

這是一些市場驅動的，但也是投資組合。

But I would put our focus, and where our focus is, is on this medium- and long-term agenda: accelerating innovation, changing our mix into these higher-growth product segments and improving productivity.

但我會把我們的重點放在這個中長期議程上：加速創新，改變我們的組合進入這些高增長的產品領域並提高生產力。

We've recently launched or soon will be launching a number of products: 2 in aquaculture, a vaccine and a parasiticide; a salmonella vaccine in broilers; and we've recently received an approval for our flea-tick combo product in EU.

我們最近推出或即將推出多種產品： 2 水產養殖、疫苗和殺蟲劑；肉雞沙門氏菌疫苗；我們最近在歐盟獲得了我們的跳蚤組合產品的批准。

So our business mix is improving with vaccines, nutritionals and companion animals, and it's becoming a larger part of our business.

因此，我們的業務組合正在通過疫苗、營養品和伴侶動物得到改善，它正在成為我們業務的重要組成部分。

Finally, I would just say that we've got many productivity streams that will improve overall operations in both manufacturing and sales efficiency

最後，我只想說，我們有許多生產力流，可以提高製造和銷售效率的整體運營

Thank you, Jeff.

謝謝你，傑夫。

John, if we can go to the next caller?

約翰，我們能不能去找下一個來電者？

And that will be line of Umer Raffat with Evercore.

這將是 Umer Raffat 與 Evercore 的路線。

I actually wanted to focus on marketed product, if I may, and perhaps starting off on the diabetes side.

如果可以的話，我實際上想專注於銷售的產品，也許從糖尿病方面開始。

I was curious what the dynamic is behind Humalog franchising pricing pressure in U.S., but Humulin franchise seeing pricing tailwinds this quarter.

我很好奇 Humalog 在美國的特許經營定價壓力背後的動態是什麼，但 Humulin 特許經營在本季度看到了定價順風。

So that was one.

所以這是一個。

On Taltz perhaps, in psoriasis, curious how you're thinking about how IL-23 competition impacts the trajectory going forward or not.

也許在 Taltz 上，在牛皮癬中，你會如何思考 IL-23 競爭如何影響未來的軌跡。

And then finally, I found it interesting that you mentioned Alimta U.S. is tracking at decreased demand despite the Keytruda approval in KEYNOTE-021G.

最後，我發現有趣的是，您提到儘管 Keytruda 在 KEYNOTE-021G 中獲得批准，但 Alimta 美國仍在追踪需求下降。

And I was just curious what the dynamic is there.

我只是好奇那裡的動態是什麼。

Umer, thank you for the questions.

烏默爾，謝謝你的提問。

So Enrique, we'll go to you for the Humalog and Humulin pricing dynamics; Christi, to you for the question on IL-23 impact to Taltz; and then, Sue, the U.S. Alimta question.

因此，Enrique，我們將向您諮詢 Humalog 和 Humulin 的定價動態； Christi，關於 IL-23 對 Taltz 的影響的問題；然後，蘇，美國的 Alimta 問題。

Enrique?

恩里克?

Sure.

當然。

So as we've noted during previous earnings calls, we expect some volatility around our U.S. Humalog sales.

因此，正如我們在之前的財報電話會議中所指出的那樣，我們預計我們在美國的 Humalog 銷售會出現一些波動。

We expect that to continue given that we make estimates on rebates and discounts at the end of each quarter.

鑑於我們在每個季度末對回扣和折扣進行估計，我們預計這種情況將繼續下去。

We do not learn about the actual utilization until later periods.

我們直到後期才了解實際使用情況。

Now maybe the best way to characterize Humalog is to basically try to look at the underlying performance and try to normalize for some of these changes that are related to prior periods.

現在，也許表徵 Humalog 的最佳方法是基本上嘗試查看潛在性能，並嘗試對與前期相關的一些變化進行標準化。

When we normalize Humalog, Humalog sales are declining about 5%.

當我們將 Humalog 標準化時，Humalog 的銷售額下降了約 5%。

There is growth in the low single digits when it comes to volume, but pricing basically declining on -- in the mid- to high single digits.

就銷量而言，有低個位數的增長，但價格基本上在下降——在中高個位數。

Now why is price declining?

現在為什麼價格下降？

It's we continue to see pressure when it comes to increased rebates.

在增加回扣方面，我們繼續看到壓力。

And also, we basically see a continued shift towards a mix of the segments where the higher rebated segments are basically growing faster, i.e., in Medicaid, to point one example.

而且，我們基本上看到了向混合領域的持續轉變，其中高回扣部分基本上增長更快，即在醫療補助中，舉一個例子。

In the case of Humulin, I think the situation is a bit different.

在 Humulin 的情況下，我認為情況有點不同。

So we grew in the U.S. Humulin 11%.

所以我們在美國的 Humulin 增長了 11%。

I think we need to keep in mind that when it comes to Humulin now, 60% of our revenue in Humulin is really -- almost 60% is coming from U-500 and only the rest from U-100, very different trends.

我認為我們需要記住，現在談到 Humulin 時，我們在 Humulin 的收入的 60% 是真的 - 幾乎 60% 來自 U-500，只有其餘的來自 U-100，非常不同的趨勢。

U-100 is declining while U-500 is basically increasing right now revenue at about 20%.

U-100 正在下降，而 U-500 目前基本上以 20% 左右的速度增長。

So different dynamics there, and that's why I think it's -- you're seeing the reported results.

那裡的動態如此不同，這就是我認為的原因 - 你看到了報告的結果。

Great, thank you, Enrique.

太好了，謝謝你，恩里克。

Christi?

克里斯蒂?

Yes, we're still very excited about Taltz and what we're seeing in the marketplace.

是的，我們仍然對 Taltz 和我們在市場上看到的東西感到非常興奮。

The study has translated into the real world.

該研究已轉化為現實世界。

We're seeing fast response, clear response.

我們看到快速響應、明確響應。

And we think we've set a pretty high bar if you look at NBRx growth.

如果你看看 NBRx 的增長，我們認為我們已經設定了一個相當高的標準。

With the IL-23s coming to market, however, we do believe it's an opportunity for patients to raise the bar on their own expectations so that the market will actually grow for the newer agents, which will help all of the new agents that have higher efficacy, especially if you look at the head-to-head trials.

然而，隨著 IL-23 上市，我們確實相信這是一個讓患者提高自己期望標準的機會，這樣新藥的市場就會真正增長，這將有助於所有具有更高療效的新藥。功效，特別是如果您查看面對面的試驗。

So we expect to see the market of the newer agents grow, and we're very excited.

因此，我們希望看到新代理商的市場增長，我們非常興奮。

As you know, we talked on our last earnings call that we submitted for psoriatic arthritis for Taltz, and we expect to hear back by the end of the year on our submission.

如您所知，我們在上次財報電話會議上討論了我們為 Taltz 提交的銀屑病關節炎，我們希望在今年年底前收到我們提交的回复。

Great.

偉大的。

Thank you, Christi.

謝謝你，克里斯蒂。

Sue?

起訴？

Yes, with regard to Alimta, we've seen a steady decline in Alimta share of market over the year or so, really through -- due to IO competition as well as some of the targeted agents like the ALK inhibitors.

是的，關於 Alimta，我們已經看到 Alimta 的市場份額在一年左右的時間裡穩步下降，實際上是由於 IO 競爭以及一些目標藥物（如 ALK 抑製劑）。

So this has been pretty consistent, and we've seen that.

所以這是相當一致的，我們已經看到了。

So we do have a decline over last year, although we did see an increase Q2 versus Q1.

所以我們確實比去年有所下降，儘管我們確實看到第二季度與第一季度相比有所增加。

We think that's mainly buying patterns.

我們認為這主要是購買模式。

The KEYNOTE-021G data clearly is important, and we're delighted that the NCCN has now listed that as a Category 2A.

KEYNOTE-021G 數據顯然很重要，我們很高興 NCCN 現在將其列為 2A 類。

So we do believe that we'll see a use there, although it's too early to say how much use at this point.

所以我們相信我們會在那裡看到用途，儘管現在說有多少用途還為時過早。

And it's also important to note that it -- with the combination with Alimta, it's probably going to be used in the PD-L1 low patient population, of which Alimta has got about a 50% market share there.

同樣重要的是要注意它 - 通過與 Alimta 的組合，它可能會用於 PD-L1低患者群體，其中 Alimta 在那裡獲得了約 50% 的市場份額。

So although we believe that we will see use, we don't anticipate that we're going to drive growth of Alimta through this.

因此，儘管我們相信我們會看到用途，但我們預計我們不會通過這個來推動 Alimta 的增長。

Thank you, Sue.

謝謝你，蘇。

John, next caller, please.

約翰，請下一位來電。

And we'll go to Steve Scala with Cowen.

我們將與 Cowen 一起前往 Steve Scala。

First, a question for Dave on baricitinib.

首先，戴夫關於巴瑞替尼的問題。

It seems that Lilly and FDA have a significant difference of opinion on regulatory requirements.

看來禮來公司和 FDA 對監管要求的意見存在顯著差異。

How in your experience are such differences resolved?

根據您的經驗，這些差異是如何解決的？

And what are the mechanisms and time frame for doing so to get the best possible outcome for Lilly?

為禮來獲得最佳結果的機制和時間框架是什麼？

So that's the first question.

所以這是第一個問題。

And secondly, why is the baricitinib psoriatic arthritis trial initiation being delayed?

其次，為什麼巴瑞替尼銀屑病關節炎試驗開始被推遲？

Is it to clarify the landscape for the molecule overall?

是為了闡明整個分子的格局嗎？

Or is it some indication-specific reason?

或者它是一些特定於指示的原因？

Thanks for your questions.

感謝您的提問。

Dave, for the first general question, on the situation with FDA.

戴夫，關於第一個一般性問題，關於 FDA 的情況。

And then, Christi, to you for the second question on psoriatic arthritis.

然後，克里斯蒂，關於銀屑病關節炎的第二個問題。

Yes, thanks, Steve.

是的，謝謝，史蒂夫。

Obviously, as Christi said and we noted in our remarks, we're disappointed with the outcome.

顯然，正如克里斯蒂所說，我們在評論中指出，我們對結果感到失望。

I think we do have clarity on what the FDA's point of view is.

我認為我們確實清楚 FDA 的觀點是什麼。

It's just not our point of view, and therein lies the difference.

這不是我們的觀點，這就是不同之處。

Now they're the regulator.

現在他們是監管者。

We need to engage with them and find the best path forward, considering time but also label quality for baricitinib and RA.

我們需要與他們合作並找到最佳的前進道路，同時考慮時間以及巴瑞替尼和 RA 的標籤質量。

The resolution of this, to me, there's a variety of tools available to us.

對我來說，解決這個問題有多種工具可供我們使用。

One of those is to do new clinical work, as we indicated, that the FDA has requested we do that.

其中之一是進行新的臨床工作，正如我們所指出的，FDA 已要求我們這樣做。

That's something certainly we're scoping and looking at now.

這當然是我們現在正在研究和關注的問題。

In addition, all of the original 4 FDA studies we did in the Phase III program continue.

此外，我們在 III 期項目中所做的所有最初的 4 項 FDA 研究都在繼續。

And so we continue to pile up events, albeit on a baricitinib-only basis, to compare to background rates, et cetera, and I think that's important.

因此，我們繼續積累事件，儘管僅在巴瑞替尼的基礎上，與背景率等進行比較，我認為這很重要。

And then launching in Europe and Japan will quickly eclipse the number of patients treated in clinical trials with those treated in the real world, and I think that's also an important set of data to help us work through what is a safety issue of low incidence, which I think Seamus asked about earlier, how do you resolve that.

然後在歐洲和日本推出將很快使在臨床試驗中接受治療的患者數量與在現實世界中接受治療的患者數量相形見絀，我認為這也是一組重要的數據，可以幫助我們解決低發病率的安全問題，我想 Seamus 之前問過這個問題，你如何解決這個問題。

It's going to be a combination of those levers, coupled with other tools we can use, whether it be labeling or otherwise, to work through this FDA situation.

這將是這些槓桿的組合，再加上我們可以使用的其他工具，無論是標籤還是其他，來解決 FDA 的這種情況。

We're trying to give investors a reasonable expectation as to the time line for resubmission and then approval, because we know that was a big open question.

我們試圖讓投資者對重新提交和批准的時間線有一個合理的期望，因為我們知道這是一個很大的懸而未決的問題。

That all said, and as Christi said, we're highly committed to the asset.

綜上所述，正如克里斯蒂所說，我們高度致力於這項資產。

We've got a long IP runway.

我們有一條很長的 IP 跑道。

We think JAK inhibitors are profound improvements for patients and particularly baricitinib, given its unique profile in early RA especially.

我們認為 JAK 抑製劑對患者，尤其是巴瑞替尼具有深刻的改善作用，尤其是考慮到其在早期 RA 中的獨特特徵。

And we aim to get it there, along with other NILEXs which we can pursue, like atopic derm, SLE, et cetera.

我們的目標是實現它，以及我們可以追求的其他 NILEX，如特應性皮膚病、SLE 等。

So it's definitely disappointing, but we're committed to move forward.

所以這絕對令人失望，但我們致力於繼續前進。

And we have a variety of tools to advance this one.

我們有多種工具來推進這一目標。

Thank you, Dave.

謝謝你，戴夫。

Christi?

克里斯蒂?

Yes, and on the question on psoriatic arthritis, based on the fact that it's the same division reviewing RA and psoriatic arthritis, we felt it was prudent for us to take a pause, ensuring that we incorporated feedback from the FDA so that as we pursue the indication, we knew that we were aligned.

是的，關於銀屑病關節炎的問題，基於審查 RA 和銀屑病關節炎的同一部門這一事實，我們認為我們暫停一下是謹慎的做法，確保我們納入了 FDA 的反饋，以便在我們追求跡象表明，我們知道我們是一致的。

And so that's what we've done, and that's why now we're telling you that we are going to push the go button, and in 2018, we'll be pursuing that trial for bari in psoriatic arthritis.

這就是我們所做的，這就是為什麼現在我們要告訴你，我們將按下啟動按鈕，在 2018 年，我們將繼續進行 bari 治療銀屑病關節炎的試驗。

Thank you, Christi.

謝謝你，克里斯蒂。

John, if we can go to the next caller, please?

約翰，如果我們可以去找下一位來電者，好嗎？

We'll go to Jami Rubin with Goldman Sachs.

我們將和高盛一起去 Jami Rubin。

Just sticking with that topic on baricitinib, at what point or is there actually a point, where you just decide it's not worth going forward, just given that there are other newer agents coming to the market and RA is a really entrenched market op -- really entrenched market to begin with?

只是堅持關於巴瑞克替尼的那個話題，在什麼時候或者實際上有一個點，你只是決定它不值得繼續前進，只是考慮到有其他新的藥物進入市場，而 RA 是一個非常根深蒂固的市場操作——真正根深蒂固的市場從何開始？

I mean, is there are a point that you just say it's not worth it or not?

我的意思是，你只是說不值得還是不值得？

And then should we also assume that the atopic dermatitis and lupus indications are also put on hold until you get better clarity with FDA?

然後我們是否還應該假設特應性皮炎和狼瘡的適應症也被擱置，直到您對 FDA 有更好的了解？

And then my second question relates to SUSTAIN 7, which, I believe, should be reported out sometime in the third quarter.

然後我的第二個問題與 SUSTAIN 7 有關，我認為應該在第三季度的某個時候報告出來。

Can you remind us, Dave, your expectations for that study?

戴夫，你能提醒我們你對這項研究的期望嗎？

I think you've said before that you would expect semaglutide to show better efficacy but maybe worse safety than Trulicity.

我想你之前說過你會期望 semaglutide 表現出更好的療效，但可能比 Trulicity 更安全。

And if SUSTAIN 7 is positive, how do you maintain market share of Trulicity?

如果 SUSTAIN 7 是積極的，您如何保持 Trulicity 的市場份額？

Thanks, Jami.

謝謝，傑米。

So Dave, let's go to you for the first question on baricitinib for procedural aspects and if we'd ever get to a point where we wouldn't go forward with RA.

所以戴夫，讓我們來問你關於巴瑞克替尼的第一個問題，關於程序方面的問題，以及我們是否會達到我們不會繼續使用 RA 的地步。

And then, Christi, if you could comment on plans for atopic dermatitis and Lupus.

然後，克里斯蒂，請您對特應性皮炎和狼瘡的計劃發表評論。

And then, Enrique, on our view on SUSTAIN 7. Dave?

然後，恩里克，關於我們對 SUSTAIN 7 的看法。戴夫？

Yes, thanks, Jami.

是的，謝謝，傑米。

The bottom line is we're a long way from anything like that point that you're highlighting, for a couple reasons.

最重要的是，出於幾個原因，我們距離您強調的這一點還有很長的路要走。

I think first, rheumatoid arthritis remains both a large unmet need and the largest category in the autoinflammatory space.

我認為首先，類風濕性關節炎仍然是一個巨大的未滿足需求，也是自身炎症領域中最大的一類。

Baricitinib has proven profound benefit, best-in-class.

Baricitinib 已被證明具有深遠的益處，是同類最佳的。

We, of course, did the Humira head-to-head and methotrexate head-to-head.

當然，我們進行了 Humira 頭對頭和甲氨蝶呤頭對頭。

And so what we need to do is put behind us the sunk costs of this and just look forward and say how competitive is the next investment, given the opportunity we have in that space and the unmet need available?

因此，我們需要做的是把沉沒成本拋在腦後，然後展望一下，考慮到我們在該領域擁有的機會和未滿足的需求，下一次投資的競爭力如何？

We feel very strongly that that's positive, and we're going to be pushing forward.

我們強烈認為這是積極的，我們將繼續前進。

The IP runway, as I mentioned, is very long, probably through the end of the next decade.

正如我所提到的，IP 跑道很長，可能會持續到下一個十年末。

And the way the market works, as you're pointing out, it's dense with competition.

正如您所指出的，市場的運作方式充滿了競爭。

A breadth of indication strategy is probably important for any JAK inhibitor.

廣泛的適應症策略可能對任何 JAK 抑製劑都很重要。

And without RA in that mix, it probably affects the competitiveness of all the indications.

如果沒有 RA，它可能會影響所有適應症的競爭力。

So right now, we're focused on getting to the next step.

所以現在，我們專注於進入下一步。

We're confident we're going to get through this with the FDA.

我們有信心與 FDA 一起度過難關。

And Christi can comment on the other indications, but we're moving ahead.

克里斯蒂可以評論其他跡象，但我們正在繼續前進。

And of course, remember, the OUS environment for baricitinib is very positive.

當然，請記住，巴瑞克替尼的 OUS 環境非常積極。

We have a great label in Europe and Japan, that those TNF markets are also very, very large, and we're focused on executing the launches in those spaces, and they'll need additional indications as well.

我們在歐洲和日本有一個很好的標籤，這些 TNF 市場也非常非常大，我們專注於在這些領域執行發布，他們也需要額外的跡象。

Great.

偉大的。

Thanks, Dave.

謝謝，戴夫。

Christi?

克里斯蒂?

Yes, so the psoriatic arthritis trial was the only trial that we've paused.

是的，所以銀屑病關節炎試驗是我們暫停的唯一試驗。

We've had good conversations with the derm division at FDA.

我們與 FDA 的皮膚部門進行了很好的交談。

Atopic dermatitis and lupus have not been paused.

特應性皮炎和狼瘡尚未停止。

They are continuing as planned.

他們正在按計劃繼續進行。

And as I said before, we expect data to be released at a scientific session before the end of the year on atopic derm, and we expect data on SLE either later this year or beginning of next year.

正如我之前所說，我們預計將在今年年底前的科學會議上發布特應性皮膚的數據，我們預計 SLE 的數據將在今年晚些時候或明年年初發布。

Thank you, Christi.

謝謝你，克里斯蒂。

Enrique?

恩里克?

So Jami, when it comes to SUSTAIN 7, of course we have to wait for the results.

所以 Jami，說到 SUSTAIN 7，我們當然要等待結果。

But based on some of the modeling that we've done, what are we expecting, which I think is your question?

但是基於我們已經完成的一些建模，我們期待什麼，我認為這是你的問題？

And one is, we expect that they're going to show a difference when it comes to weight.

一個是，我們希望它們在重量方面會有所不同。

And we believe that they're going to show a small difference when it comes to hemoglobin from Day 1. Clearly, we need to weigh all of that against any label that they have made, [we receive], and that is up to the regulators.

而且我們相信，從第一天開始，他們在血紅蛋白方面會表現出微小的差異。顯然，我們需要權衡所有這些與他們所做的任何標籤，[我們收到]，這取決於監管機構。

But you are likely aware as part of SUSTAIN 6, they -- semaglutide showed a signal when it comes to retinopathy.

但您可能知道，作為 SUSTAIN 6 的一部分，他們 - semaglutide 在視網膜病變方面顯示出信號。

The specifics of how was that defined, it's -- whether it's blinded, hemorrhaging, ocular injections and so forth.

具體是如何定義的，它是——是否失明、出血、眼部注射等等。

So clearly, we need to wait for the totality of the data and for the discussions that Novo Nordisk will have with the FDA.

很明顯，我們需要等待數據的全部以及諾和諾德將與 FDA 進行的討論。

We view this as an important competitor to us, and we are very much prepared to continue to grow Trulicity going forward.

我們認為這是我們的一個重要競爭對手，我們非常準備繼續發展 Trulicity。

Thank you, Enrique.

謝謝你，恩里克。

John, next caller, please.

約翰，請下一位來電。

We'll go to Gregg Gilbert with Deutsche Bank.

我們將和德意志銀行一起去 Gregg Gilbert。

Maybe just going back to clean up on animal health.

也許只是回去清理動物健康。

Dave, any updated thoughts on Elanco and how it fits into the long-term value creation story you have for Lilly?

戴夫，關於 Elanco 的任何最新想法以及它如何融入您為禮來 (Lilly) 的長期價值創造故事？

I assume you've had adequate time now to really dig in on that.

我想你現在有足夠的時間來真正深入研究它。

And then on the pipeline, is there anything you can share about what was learned in the interim analysis for the BACE inhibitor?

然後在管道上，您有什麼可以分享的關於在 BACE 抑製劑的中期分析中學到的東西嗎？

And on the DACRA, if I could call it that, how might that be differentiated from Trulicity?

在 DACRA 上，如果我可以這樣稱呼它，那與 Trulicity 有何區別？

Okay, Gregg, thank you for the questions.

好的，格雷格，謝謝你的提問。

Dave, if you want to comment on the first animal health question.

戴夫，如果你想評論第一個動物健康問題。

And then, Jan, if you'd like to maybe comment on the interim that we had for the BACE inhibitor as well as the DACRA.

然後，Jan，如果您想評論一下我們對 BACE 抑製劑和 DACRA 的過渡期。

Enrique, obviously, please feel free to comment on that one as well.

恩里克，顯然，也請隨時對此發表評論。

Dave?

戴夫？

Yes, Gregg, I think this question has come up before, and I'll say the same thing, which is, in any case, we need to constantly review our portfolio.

是的，格雷格，我認為這個問題之前已經提出過，我會說同樣的話，那就是，無論如何，我們需要不斷地審查我們的投資組合。

We need to make sure all of our assets we have a basis for holding and driving incremental value versus what anyone else can do.

我們需要確保我們所有的資產都有一個基礎來持有和推動增值，而不是其他任何人都可以做的。

And that's -- animal health is no different from that.

那就是 - 動物健康與此沒有什麼不同。

Right now, as Jeff indicated in his answer in terms of the performance issues and in my early days here, we've been very focused on operational improvements.

現在，正如 Jeff 在他關於性能問題的回答中指出的那樣，在我在這裡的早期，我們一直非常專注於運營改進。

We've put together a number of companies, including the Novartis combination.

我們已經整合了許多公司，包括諾華的組合。

And in my experience and also, I think, in our real experience, it's -- it takes some effort and work to get to true operational effectiveness after that kind of combination.

根據我的經驗，我認為，根據我們的實際經驗，在這種組合之後，需要一些努力和工作才能達到真正的運營效率。

We also have some environmental headwinds we need to reposition against.

我們還需要重新定位一些環境逆風。

Jeff outlined our response to those.

傑夫概述了我們對這些的回應。

So that's really our focus right now.

所以這確實是我們現在的重點。

But your question is a good one.

但是你的問題很好。

We'll constantly be asking ourselves that question.

我們會不斷地問自己這個問題。

And of course, if we have a new thought about that, we'll come back to the investment community.

當然，如果我們對此有新的想法，我們會回到投資界。

Great.

偉大的。

Thanks, Dave.

謝謝，戴夫。

Jan?

簡?

In relation to the interim BACE study, this analysis looked at the safety and also assessment if there were cognitive worsening and a sample size re-estimation.

關於中期 BACE 研究，該分析著眼於安全性，並評估是否存在認知惡化和样本量重新估計。

And the recommendation was to continue the trial as planned and not change the size of the trial.

建議按計劃繼續試驗，不改變試驗規模。

The continuation of this trial, we should remind also people that it is in amyloid-positive patients, and it's the prodromal and the mild population.

繼續這項試驗，我們也應該提醒人們，它是在澱粉樣蛋白陽性患者中，它是前驅和輕度人群。

If we talk about the new DACRA and the calcitonin amylin receptor agonist, this is an interesting new class of agents that potentially could have a superior weight loss with a competitive glucose lowering.

如果我們談論新的 DACRA 和降鈣素胰淀素受體激動劑，這是一類有趣的新型藥物，它可能會通過競爭性降低葡萄糖來實現卓越的減肥效果。

That's one way of describing it.

這是描述它的一種方式。

Potentially less nausea as well.

也可能減少噁心。

And the key thing here could be insulin sensitization.

這裡的關鍵可能是胰島素致敏。

And this agent is different from the GLP-1 since it doesn't release insulin but rather enhances sensitization for insulin, which could mean even a better durability of the glucose lowering and effect.

而且這種藥劑與 GLP-1 不同，因為它不釋放胰島素，而是增強對胰島素的敏感性，這可能意味著更好的降糖效果和持久性。

Great.

偉大的。

Thank you, Jan.

謝謝你，簡。

John, can we go to the next caller?

約翰，我們可以去找下一個來電者嗎？

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。

On galcanezumab, lots of data across the CGRP landscape this year.

關於 galcanezumab，今年 CGRP 領域的大量數據。

How are you guys thinking about the payer attitudes before the filing?

你們在提交申請之前如何考慮付款人的態度？

And I can't remember, have you guys -- is the launch reflected in your long-term revenue growth guidance?

我不記得了，你們有沒有 - 發布是否反映在你們的長期收入增長指導中？

And then a bigger-picture question on biz dev, you guys provided a pretty specific strategy on oncology.

然後是關於 biz dev 的一個更宏觀的問題，你們提供了一個非常具體的腫瘤學策略。

How much does valuation inform the decision or the urgency?

估值對決策或緊迫性有多大影響？

And, what's the relative attractiveness to other categories such as neuroscience inflammation, et cetera?

而且，對神經科學炎症等其他類別的相對吸引力是什麼？

Okay.

好的。

Geoff, thank you for the questions.

傑夫，謝謝你的提問。

So Christi, if you could comment on how we view payer attitudes in the migraine space.

所以克里斯蒂，如果你能評論一下我們如何看待偏頭痛領域的付款人態度。

Derica, if you can comment on whether or not galcanezumab is in our sort of midterm financial expectations.

Derica，如果你能評論一下 galcanezumab 是否在我們的中期財務預期中。

And then, Dave, if you'll take the last question.

然後，戴夫，請您回答最後一個問題。

Christi?

克里斯蒂?

So we're very excited, first of all, about galcanezumab.

因此，我們首先對 galcanezumab 感到非常興奮。

If you think about patients losing up to 50 days of their life every year and being able to cut that in half, it's just an amazing proposition.

如果您考慮患者每年最多失去 50 天的生命並且能夠將其減少一半，那真是一個了不起的提議。

We do know we're not going to be the only product on the market and we'll have a lot of competition.

我們知道我們不會成為市場上唯一的產品，我們將面臨很多競爭。

But I think we have a couple of things.

但我認為我們有幾件事。

One, I don't -- we don't see any other CGRP data that's better than our own.

一，我沒有——我們沒有看到比我們自己的更好的任何其他 CGRP 數據。

We look at the data and see that if you look at the response rate, about 60% of patients respond, have a greater than 50% response rate, 33% at greater than 75% response rate and about 12% or 1 in 8 patients will have a 100% response rate.

我們查看數據，如果您查看響應率，大約 60% 的患者有響應，響應率大於 50%，33% 的響應率大於 75%，大約 12% 或八分之一的患者會有100%的回复率。

So we feel like we have a very strong efficacy profile, couple that with a really good benefit/risk ratio.

所以我們覺得我們有一個非常強大的療效概況，再加上一個非常好的收益/風險比。

So that's number one on galcanezumab.

所以這是 galcanezumab 的第一名。

On the contracting piece, the great thing that we have at Lilly is a background in neuroscience, and we have a paying platform.

在合同方面，我們在禮來的優勢在於神經科學背景，而且我們有一個付費平台。

It's not just galcanezumab, but as we go to payers soon after galcanezumab, we'll be looking at lasmiditan, which already completed one Phase III study.

這不僅僅是 galcanezumab，而且當我們在 galcanezumab 之後不久就向付款人付款時，我們將關注 lasmiditan，它已經完成了一項 III 期研究。

The next Phase III study will be completed by the end of the year.

下一個 III 期研究將在今年年底完成。

And then follow that a little bit further with our partnership with Pfizer on tanezumab.

然後通過我們與輝瑞公司在 tanezumab 上的合作，進一步了解這一點。

We're looking at really putting a dent in the opioid crisis in the United States.

我們正在考慮真正緩解美國的阿片類藥物危機。

And as we look at the entire platform, we feel pretty confident going into the discussions with payers in the U.S.

當我們審視整個平台時，我們對與美國的付款人進行討論感到非常有信心。

Thank you, Christi.

謝謝你，克里斯蒂。

Derica?

德麗卡？

Yes, the simple answer is yes, it is in, but on a probabilized basis, as we do with the majority of our late-stage portfolio assets.

是的，簡單的答案是肯定的，它存在，但在概率的基礎上，就像我們對大部分後期投資組合資產所做的那樣。

Perfect.

完美的。

Dave?

戴夫？

Yes, so I guess your broad question on BD.

是的，所以我猜你關於 BD 的廣泛問題。

With any transaction, oncology is no different.

對於任何交易，腫瘤學也不例外。

We're going to look at several factors.

我們將研究幾個因素。

Of course, how it fits within our strategy, both clinically and business-wise, the portfolio and the opportunity to combine it with other things is, of course, very important in oncology.

當然，它在臨床和商業方面如何符合我們的戰略、產品組合以及將其與其他事物相結合的機會，當然在腫瘤學中非常重要。

And then -- so that depends on the assets we're holding.

然後 - 這取決於我們持有的資產。

And then, of course, we look at the valuation.

然後，當然，我們看看估值。

We need to, any transaction needs to produce returns well above our cost of capital on a risk-adjusted basis.

我們需要，任何交易都需要在風險調整的基礎上產生遠高於我們資本成本的回報。

So when we go through all those filters, it does diminish the field of available targets.

因此，當我們通過所有這些過濾器時，它確實會減少可用目標的範圍。

And we also, at Lilly, I think we're pretty flexible.

而且，在禮來，我認為我們非常靈活。

We're not -- we don't have to own things outright.

我們不是——我們不必完全擁有東西。

I think we're happy to share risk, et cetera, and oncology is no different from that.

我認為我們很樂意分擔風險等等，腫瘤學與此沒有什麼不同。

Relative attractiveness is an interesting question.

相對吸引力是一個有趣的問題。

I would say in recent times, we've seen that price points for oncology, particularly post-PoC, are very challenging to get to a number.

我想說的是，最近，我們已經看到腫瘤學的價格點，特別是 PoC 後的價格點，很難獲得一個數字。

Our strategy, as communicated today by Sue and Levi, is to really open up that field and look at earlier projects, maybe take a little more risk, trading in front of the proof of concept, but making scientific judgments and then seeing those bear out.

正如 Sue 和 Levi 今天所傳達的，我們的策略是真正開放該領域並查看早期項目，可能會承擔更多風險，在概念驗證之前進行交易，但做出科學判斷，然後看到結果.

In that way, we could probably do more transactions that might be smaller, and if we make the right judgments, have that pay off for our shareholders.

那樣的話，我們可能會做更多可能更小的交易，如果我們做出正確的判斷，我們的股東就會得到回報。

Relative to other areas, oncology has a lot of targets.

相對於其他領域，腫瘤學的靶點很多。

But I would say relatively, the pricing is on the higher end.

但我會說相對而言，定價處於較高端。

We like immunology a lot.

我們非常喜歡免疫學。

There's also a lot of targets there.

那裡也有很多目標。

And pricing, while creeping up, is still good.

定價雖然在攀升，但仍然不錯。

You saw the deal yesterday on the Nektar transaction, which we thought was an exceptional financial transaction and fits our strategy and is a compelling clinical asset.

您昨天看到了 Nektar 交易的交易，我們認為這是一項特殊的金融交易，符合我們的戰略，是一項引人注目的臨床資產。

And then in other fields, like KeyBioscience, Jan was just talking about the DACRA platform, there are opportunities.

然後在其他領域，比如 KeyBioscience，Jan 只是在談論 DACRA 平台，有機會。

So across our 5 TAs, oncology included, we look at everything, and we are disciplined on our financial analysis but also strategy and clinical value.

因此，在我們的 5 個 TA（包括腫瘤學）中，我們著眼於一切，我們在財務分析以及戰略和臨床價值方面都受到紀律處分。

Great.

偉大的。

Thank you, Dave.

謝謝你，戴夫。

John, if we could go to the next caller?

約翰，我們能不能去找下一個來電者？

We'll go to Vamil Divan with Credit Suisse.

我們將和瑞士信貸一起去 Vamil Divan。

Thanks for the overview on the oncology strategy.

感謝您對腫瘤學策略的概述。

So a couple of follow-ups, just on the oncology side.

所以有幾個後續行動，只是在腫瘤學方面。

CSF1R, I think, is a mechanism that we have heard pretty good interest from, from (inaudible), so I was a little surprised when you mentioned that's more of a Tier 2 asset now, and you said it was the magnitude of efficacy that you want to see.

我認為，CSF1R 是一種我們從（聽不清）聽到的非常感興趣的機制，所以當你提到它現在更像是第 2 層資產時，我有點驚訝，你說它的功效幅度你想看。

Maybe you can just -- to give a little more detail on what you're looking for from that asset in terms of the efficacy.

也許您可以 - 就功效方面提供更多詳細信息，說明您從該資產中尋找什麼。

And then a more general question on that front.

然後在這方面提出一個更普遍的問題。

We've seen other mechanisms, like the IDOs, for example, where you don't see much efficacy as a single agent, but it does seem to have value in combination.

我們已經看到了其他機制，例如 IDO，在這些機制中，您看不到作為單一代理的太多功效，但它似乎確實具有組合價值。

So how do you think about that when you're making your prioritization decisions, sort of in early stage and maybe putting your mechanism as a lower priority when there might be an opportunity in a different indication or in combination?

那麼，當您在早期階段做出優先級決定時，您如何考慮這一點，並且在可能存在不同跡像或組合的機會時將您的機制置於較低優先級？

And then second, just on abemaciclib, following up on some of the earlier comments.

其次，僅在 abemaciclib 上，跟進之前的一些評論。

We've heard for a while about some of the opportunity here for this class and this drug outside of breast cancer, and you mentioned non-small cell, and I think squamous and pancreatic cancer on your slide.

我們已經聽說了這個課程和這種藥物在乳腺癌之外的一些機會，你提到了非小細胞，我認為你的幻燈片上有鱗狀細胞癌和胰腺癌。

Can you just give us a sense of when we might start seeing some more data on these other tumor types to get a sense of the potential for the drug and the class outside of breast cancer?

你能告訴我們什麼時候我們可能會開始看到更多關於這些其他腫瘤類型的數據，以了解該藥物的潛力和乳腺癌以外的類別嗎？

Great.

偉大的。

Vamil, thank you for the questions.

瓦米爾，謝謝你的提問。

Levi, if you'll take maybe the first 2, for sure, the CSF1R and then how we view agents that might not have single-agent activity but could be useful in combos.

Levi，如果你可能會選擇前兩個，當然，CSF1R，然後我們如何看待可能沒有單一代理活動但可能在組合中有用的代理。

And then, Sue and Levi, maybe you can both contribute to the answer to the last question on timing for readouts for abema outside of breast cancer.

然後，Sue 和 Levi，也許你們都可以為最後一個關於乳腺癌以外的 abema 讀數時間問題的答案做出貢獻。

Levi?

利威爾？

Sure.

當然。

Well, thanks for the question.

嗯，謝謝你的問題。

So with CSF1R, so just going back to our decision framework, there are several considerations that we have when we're looking at whether or not an asset is going to clear the bar.

因此，對於 CSF1R，讓我們回到我們的決策框架，當我們查看資產是否會清除標準時，我們有幾個考慮因素。

In addition to the scientific rationale, we're also looking at clinical magnitude and and also the commercial landscape.

除了科學原理外，我們還在研究臨床規模以及商業前景。

But I think with CSF1R in particular, that's an example where it's a crowded space, and so our decision-making about how aggressive Lilly invests will be determined by the distinctive characteristics of our agent in our study.

但我認為尤其是 CSF1R，這是一個擁擠空間的例子，因此我們關於禮來投資的積極性的決策將取決於我們研究中代理人的獨特特徵。

So -- and we have a couple of studies ongoing which will inform that.

所以 - 我們正在進行一些研究，這將提供信息。

With regard to the other question, which is -- you're absolutely correct, it is a very important point that as we build rational regimens, we're increasingly seeing that key members of regimens may or may not have that impressive single-agent activity.

關於另一個問題，你是絕對正確的，這是非常重要的一點，當我們建立合理的治療方案時，我們越來越多地看到治療方案的關鍵成員可能有也可能沒有那個令人印象深刻的單一代理活動。

And IDO could be an example.

IDO 就是一個例子。

And one could even argue that some of the other CDK inhibitors were examples of that.

人們甚至可以爭辯說，其他一些 CDK 抑製劑就是這樣的例子。

So this is another example why it's so important to think about the scientific rationale, what is the biology that's operant, what are we trying to target and is there a reason to believe that if we put a combination together, will it get a much greater effect than we might see with any individual component?

所以這是另一個例子，為什麼考慮科學原理如此重要，什麼是可操作的生物學，我們試圖瞄準什麼，是否有理由相信如果我們將組合放在一起，它會變得更大效果比我們在任何單個組件上看到的效果？

So that -- so in general -- so there's not a specific answer to the question.

所以——總的來說——所以這個問題沒有具體的答案。

Obviously, it will depend on the particular combinations and indications, but you're absolutely correct, this is increasingly something we're considering.

顯然，這將取決於特定的組合和適應症，但你是絕對正確的，這是我們正在考慮的越來越多的事情。

What's the target regimen, the combination we want to put together and the aggregate biological rationale and not just the individual components?

目標方案是什麼，我們想要組合的組合以及總體生物學原理，而不僅僅是單個成分？

With abemaciclib, let me start and you may want to say more about the other indications.

使用 abemaciclib，讓我開始，您可能想更多地了解其他適應症。

But the lung indications of the KRAS mutant lung, we should have that data in Q4 this year.

但是KRAS突變肺的肺適應症，我們應該在今年第四季度有那個數據。

So you should see that data then, or at least we'll do a top line then and we'll present the data at an upcoming meeting after that.

所以你應該看到這些數據，或者至少我們會做一個頂線，然後我們會在接下來的會議上展示數據。

And then with regards to the other studies, we are -- our ongoing study in pancreatic cancer at this present time, we should see probably data on that next year some time.

然後關於其他研究，我們目前正在進行胰腺癌研究，我們應該會在明年某個時候看到可能的數據。

And you want to comment on others?

你想評論別人嗎？

Yes, sure.

是的，當然。

So beyond that, we also have abemaciclib in conjunction with trastuzumab in what's called the monarcHER study, which is a HER2+, ER+ breast cancer.

因此，除此之外，我們還將 abemaciclib 與曲妥珠單抗聯合用於所謂的 monarcHER 研究，這是一種 HER2+、ER+ 乳腺癌。

That one is enrolling, and it may take a couple years to have that readout.

那個人正在招生，可能需要幾年時間才能得到這個讀數。

But -- then beyond that, we have a number of combination studies that we're doing with abemaciclib.

但是——除此之外，我們還有一些我們正在使用 abemaciclib 進行的組合研究。

So that's relevant to the second question.

所以這與第二個問題有關。

So we have -- those are earlier stage, but there are several, both portfolio assets and partnered assets that we are looking at in combination with abemaciclib.

所以我們有 - 這些是早期階段，但有幾個，包括投資組合資產和合作資產，我們正在與 abemaciclib 結合使用。

So we have a significant life cycle plan that we continue to add to, and that will read out over the coming years.

因此，我們有一個重要的生命週期計劃，我們將繼續添加，並將在未來幾年內宣讀。

Thank you, Levi.

謝謝你，利威爾。

Thanks, Sue.

謝謝，蘇。

John, if we can go to the next caller?

約翰，我們能不能去找下一個來電者？

We'll go to Tony Butler with Guggenheim Securities.

我們將與古根海姆證券公司一起去托尼巴特勒。

Enrique, back to Humalog, if I may.

恩里克，如果可以的話，回到 Humalog。

You made a reference to volume being up, but I'm curious about the class as a whole of rapid-acting insulins continuously down.

你提到了音量上升，但我很好奇整個班級的速效胰島素持續下降。

Is that solely based on price?

是單純看價格嗎？

Or does that actually reflect some level of a decline in overall demand?

還是這實際上反映了整體需求的某種程度的下降？

And what might those patients actually be moving toward or moving into as opposed to those rapid-acting agents?

與那些速效藥物相比，這些患者實際上正在走向或進入什麼領域？

And then secondly, very simply, Christi, when the resolution for baricitinib with the FDA, whatever it may be, another trial or some negotiation or patients who you look out in Europe and you're able to supply data to the FDA, the question really is, when you refile, does the entire NDA clock restart at a 12-month time frame?

其次，很簡單，克里斯蒂，當與 FDA 就 baricitinib 達成決議時，不管它是什麼，另一個試驗或一些談判或你在歐洲尋找的患者，你能夠向 FDA 提供數據，問題真的是，當您重新提交時，整個 NDA 時鐘是否會在 12 個月的時間範圍內重新啟動？

Or is there some other fraction of that which we need to look forward to?

還是我們需要期待的其他部分？

Tony, thank you for the questions.

托尼，謝謝你的提問。

So we'll go to Enrique for the Humalog class question for the rapid-acting insulins.

因此，我們將去 Enrique 解答速效胰島素的 Humalog 課程問題。

And then, Christi, if you want to comment or I can comment on the second question on the bari time frame once we resubmit.

然後，克里斯蒂，如果你想發表評論，或者我可以在我們重新提交後評論關於巴里時間框架的第二個問題。

Enrique?

恩里克?

Yes, the main impact here when we look at the meal-time insulin class is really related to pricing.

是的，當我們查看餐時胰島素類別時，這裡的主要影響確實與定價有關。

Now we do have, when we look at the growth rates of that class, the growth rates have come down.

現在我們確實有，當我們查看該類別的增長率時，增長率已經下降。

The class is still growing but it's growing less than it was growing 2, 3 years ago.

該課程仍在增長，但其增長速度低於 2、3 年前的增長速度。

And clearly, this is a part of basically increased utilizations of both SGLT-2s and GLP-1s.

很明顯，這是基本提高 SGLT-2 和 GLP-1 利用率的一部分。

Thank you, Enrique.

謝謝你，恩里克。

And Tony, on your question when we resubmit, our anticipation would be that the FDA would then need to declare that a type 1 or type 2 resubmission, and you would have, I believe, something like a 3- or 6-month time frame then for them to have a PDUFA date and provide their answers to the resubmission.

托尼，關於你的問題，當我們重新提交時，我們的預期是 FDA 將需要宣布重新提交 1 型或 2 型，我相信你會有 3 或 6 個月的時間框架然後讓他們有一個 PDUFA 日期並提供他們對重新提交的答案。

John, if we could have the next caller, please?

約翰，如果我們可以請下一位來電者，好嗎？

We'll go to Alex Arfaei with BMO Capital Markets.

我們將與 BMO Capital Markets 聯繫 Alex Arfaei。

A couple on Trulicity, which had a great quarter.

一對夫婦在 Trulicity，有一個很棒的季度。

First, on the cardiovascular outcomes study, the REWIND study expected next year.

首先，關於心血管結局研究，REWIND 研究預計將於明年進行。

How confident are you in that study given that 2 out of the 4 CV outcome studies with GLP-1s have failed to show a benefit?

鑑於 GLP-1 的 4 項 CV 結果研究中有 2 項未能顯示出益處，您對該研究的信心如何？

Is there anything in the design or patient characteristics that would basically suggest that the probability of success was more than a coin toss?

設計或患者特徵中是否有任何內容基本上表明成功的可能性不僅僅是拋硬幣？

And then when can we expect the results from AWARD-10 evaluating Trulicity and Jardiance?

那麼我們什麼時候可以期待 AWARD-10 評估 Trulicity 和 Jardiance 的結果呢？

It would seem like that's a promising combination.

這似乎是一個很有前途的組合。

My understanding is that the study has completed.

我的理解是研究已經完成。

Just wondering when we can see the results.

只是想知道我們什麼時候可以看到結果。

And then finally, were there any notable inventory changes for Trulicity and Taltz this quarter?

最後，本季度 Trulicity 和 Taltz 是否有任何顯著的庫存變化？

Alex, thank you for the questions.

亞歷克斯，謝謝你的問題。

Actually, before we go on, just to clarify the last answer that I'd given.

實際上，在我們繼續之前，只是為了澄清我給出的最後一個答案。

I think the type 1 is actually a 2-month turnaround, not 3 months.

我認為類型 1 實際上是 2 個月的周轉期，而不是 3 個月。

And the type 2 is, in fact, 6 months.

而類型 2 實際上是 6 個月。

Enrique, if we could go to you for the question on how we're viewing the chances for success of the REWIND trial for Trulicity and timing for AWARD-10 to read out?

恩里克，如果我們可以向您詢問我們如何看待 Trulicity 的 REWIND 試驗成功的機會以及 AWARD-10 的宣讀時間？

And then if you want to comment if there were any issues or changes in inventory levels for Trulicity.

然後，如果您想評論 Trulicity 的庫存水平是否存在任何問題或變化。

And Christi, if you want to comment on Taltz?

克里斯蒂，如果你想評論塔爾茨？

Enrique?

恩里克?

Sure.

當然。

So it's really dangerous to speculate when it comes to trial results.

因此，當涉及到試驗結果時，猜測是非常危險的。

We do have, I think, a very good experience when conducting cardiovascular trials in the diabetes space.

我認為，在糖尿病領域進行心血管試驗時，我們確實有很好的經驗。

I think Lilly probably has designed and conducted more trials than anybody else in this space, either by ourselves or with some of our partners.

我認為，無論是我們自己還是與我們的一些合作夥伴一起，禮來公司在這個領域設計和進行的試驗可能比其他任何人都多。

So we feel confident that we've designed the trial the right way as we are awaiting on those.

因此，我們相信我們已經以正確的方式設計了試驗，因為我們正在等待這些試驗。

Clearly, if we look at the different GLP-1s, I would say that not all GLP-1s are comparable.

顯然，如果我們查看不同的 GLP-1，我會說並非所有 GLP-1 都具有可比性。

So we continue to like our chances.

所以我們繼續喜歡我們的機會。

When it comes to the question on the inventory for Trulicity, nothing material when it comes to inventory.

當談到關於 Trulicity 庫存的問題時，在庫存方面沒有什麼重要的。

We had some favorability related to changes in the estimates for rebates and discounts, maybe in the neighborhood of about $15 million out of a $380 million base in the case of U.S. revenue.

我們對回扣和折扣估計的變化有一些好感，就美國收入而言，可能在 3.8 億美元的基數中約為 1500 萬美元。

And as far as AWARD-10, we should be disclosing that at an upcoming medical conference.

至於 AWARD-10，我們應該在即將召開的醫學會議上披露這一點。

Great.

偉大的。

Thank you, Enrique.

謝謝你，恩里克。

Christi?

克里斯蒂?

And an easy answer for me in regards to Taltz.

關於 Taltz 對我來說是一個簡單的答案。

Nothing unusual.

沒有什麼不尋常的。

We're really happy, in fact, to see that the volume and the demand is the reason for the uptake.

事實上，我們真的很高興看到數量和需求是吸收的原因。

Great.

偉大的。

John, and we have time, I think, for one last question from the line.

約翰，我想我們有時間來回答最後一個問題。

And we'll go to David Risinger with Morgan Stanley.

我們將與摩根士丹利一起去大衛里辛格。

So I wanted to just ask a high-level of Dave, please, and then a couple of minor quick questions.

所以我想問一個高水平的戴夫，然後問幾個小問題。

So, with respect to the outlook in Washington, it seems like the Trump administration and Congress are focused on matters other than drug pricing.

因此，就華盛頓的前景而言，特朗普政府和國會似乎專注於藥品定價以外的問題。

But it would be great to hear your updated perspective and outlook on pharma's focus in Washington and any developments you think investors should be anticipating with respect to drug pricing in the second half of this year.

但很高興聽到您對製藥公司在華盛頓的關注點的最新觀點和展望，以及您認為投資者應該在今年下半年就藥品定價進行預期的任何發展。

And then in terms of my more minor question, KEYNOTE-189 is listed as an internal readout on your slide, but not external.

然後就我的小問題而言，KEYNOTE-189 在您的幻燈片上被列為內部讀數，而不是外部讀數。

Is that simply because Merck will issue the external press release?

這僅僅是因為默克將發布外部新聞稿嗎？

Or do you not expect an external press release in the second half of this year?

或者您不希望在今年下半年發布外部新聞稿？

And then finally, Derica, on gross margin guidance, that was reduced from 77% to 76%, can you just talk about the key franchises?

最後，Derica，毛利率指引從 77% 降至 76%，你能談談主要特許經營權嗎？

And specifically, what drove that, whether it's mix or any other factors?

具體來說，是什麼推動了這一點，無論是混合還是其他因素？

Great, Dave, thank you for the questions.

太好了，戴夫，謝謝你的提問。

So Dave Ricks, we'll go to you for the first question; Sue, for the KEYNOTE-189 timing question; and then, Derica, for gross margin percent.

Dave Ricks，我們會問你第一個問題； Sue，對於 KEYNOTE-189 計時問題；然後，Derica，毛利率百分比。

Dave?

戴夫？

Sure.

當然。

Thanks, Dave.

謝謝，戴夫。

Probably, we can spend a lot of time talking about what's happening in Washington.

或許，我們可以花很多時間談論華盛頓正在發生的事情。

I'll try to be brief.

我會盡量簡短。

Look, we've responded to the concerns as an industry and as a company, I think pretty well in terms of putting proactively aligned ideas from across the industry on the table that can leverage the power of the marketplace and competition, help consumers with their out-of-pocket costs.

看，我們已經回應了作為一個行業和公司的擔憂，我認為在將來自整個行業的積極一致的想法放在桌面上可以利用市場和競爭的力量，幫助消費者自付費用。

We talked about some of these through time, whether it be rebate pass-through in the doughnut hole, outcomes-based pricing, FDA speeding up the backlog of generic approvals and the like.

我們一直在討論其中的一些問題，無論是甜甜圈洞中的回扣傳遞、基於結果的定價、FDA 加速仿製藥批准的積壓等等。

So that -- we've put all that on the table.

所以 - 我們已經把所有這些都放在了桌面上。

I think everybody in any position of authority knows about the aligned pharma agenda.

我認為任何處於權威地位的人都知道一致的製藥議程。

We do expect an executive order.

我們確實期待行政命令。

They keep saying soon.

他們一直說很快。

I would say in the second half, you should expect that.

我會說，在下半場，你應該期待這一點。

We hope that it includes many of the ideas we've put forward.

我們希望它包含我們提出的許多想法。

My personal view is that won't end the discussion about drug pricing.

我個人的觀點是，這不會結束關於藥品定價的討論。

I think we saw even, yesterday, Democrats put this as a prominent feature in their "Better Way" paper.

我想我們甚至在昨天看到，民主黨人在他們的“更好的方式”論文中將此作為一個突出特點。

And we have a number of budgetary votes coming up in the fall that may include pay-fors that include the drug industry.

我們將在秋季進行一些預算投票，其中可能包括包括製藥業在內的支付費用。

So we need to be -- continue to be on our game.

所以我們需要——繼續我們的比賽。

I think we've got a good team at PhRMA now.

我認為我們現在在 PhRMA 擁有一支優秀的團隊。

I think Lilly is doing our part within that, and the industry's on top of its game here.

我認為禮來公司在這方面發揮了我們的作用，並且該行業在這里處於領先地位。

But there is still quite a bit of risk in the environment.

但在環境中仍然存在相當大的風險。

I wouldn't want anyone to think otherwise.

我不希望任何人有其他想法。

Thank you, Dave.

謝謝你，戴夫。

Sue?

起訴？

Yes, with regards to KEYNOTE-189, remember this is outcomes driven, so it will depend on outcomes.

是的，關於 KEYNOTE-189，請記住這是結果驅動的，所以它取決於結果。

But our expectation is we could have a top line press release later this year, maybe early next year, with data being presented next year.

但我們的預期是，我們可能會在今年晚些時候，可能在明年初發布一份頂級新聞稿，並在明年公佈數據。

Great.

偉大的。

Thank you, Sue.

謝謝你，蘇。

And Derica?

德麗卡呢？

Dave, it's solely attributable to the FX effect on inventories sold.

戴夫，這完全歸因於外匯對已售庫存的影響。

And given the rate movement that we've seen recently, this is what we anticipate.

鑑於我們最近看到的利率變動，這是我們預期的。

Underlying that, we continue to see very good operating performance of our manufacturing operations.

在此基礎上，我們繼續看到我們製造業務的良好經營業績。

And recall in the slide deck that we provide you all, and the supplemental in this call is Slide 34, we always provide a look at our gross margin both with and without the FX effect.

回想一下我們為大家提供的幻燈片，本次電話會議的補充是幻燈片 34，我們總是提供有和沒有 FX 效果的毛利率。

Thanks, Derica.

謝謝，德麗卡。

That puts us at the bottom of the hour.

這使我們處於時間的底部。

Dave, if you'd like to wrap up the call.

戴夫，如果你想結束通話。

Yes, thanks, Phil.

是的，謝謝，菲爾。

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

感謝您參加今天的電話會議以及您對我們公司的興趣。

Driven by the new pharmaceutical products, through the first half of 2017, we're generating solid revenue growth, and we continue to improve our margins, leading to even faster income growth.

在新醫藥產品的推動下，到 2017 年上半年，我們實現了穩健的收入增長，我們繼續提高利潤率，從而實現更快的收入增長。

We believe that Lilly stock is a compelling investment given the diversity of our product portfolio and our top and bottom line growth prospects over the balance of the decade.

鑑於我們產品組合的多樣性以及我們在十年餘下時間的收入和利潤增長前景，我們認為禮來股票是一項引人注目的投資。

We hope that the update shared by Sue and Levi on our oncology R&D strategy provides you with greater clarity on how we intend to up our game in this really important therapy area to deliver new medicines that can redefine expectations for cancer patients.

我們希望 Sue 和 Levi 分享的關於我們的腫瘤學研發戰略的更新能讓您更清楚地了解我們打算如何在這個非常重要的治療領域提升我們的遊戲水平，以提供可以重新定義癌症患者期望的新藥。

I look forward to your continued interactions and keeping you informed of our progress.

我期待您繼續互動，並讓您了解我們的進展。

Please follow up with our IR team if you have questions we have not addressed on today's call.

如果您有我們在今天的電話會議中未解決的問題，請與我們的 IR 團隊聯繫。

Thanks, and have a great day.

謝謝，祝你有美好的一天。

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。