施貴寶 (BMY) 2013 Q4 法說會逐字稿

Good day, and welcome to today's fourth-quarter 2013 earnings call.

大家好，歡迎參加今天的 2013 年第四季度財報電話會議。

Today's call is being recorded.

今天的通話正在錄音。

At this time I would like to turn the call over to John Elicker.

現在我想把電話轉給約翰·埃里克。

Please go ahead, sir.

請繼續，先生。

Thanks Shannon, and good morning everybody.

謝謝香農，大家早上好。

Thanks for joining us to discuss our Q4 results.

感謝您加入我們討論我們的第四季度業績。

With me this morning are Lamberto Andreotti, our Chief Executive Officer; Charlie Bancroft, our Chief Financial Officer; Francis Cuss, our Chief Scientific Officer; and Giovanni Caforio, our Chief Commercial Officer.

今天早上和我在一起的是我們的首席執行官蘭貝托·安德烈奧蒂 (Lamberto Andreotti)；查理·班克羅夫特，我們的首席財務官； Francis Cuss，我們的首席科學官；以及我們的首席商務官喬瓦尼·卡福里奧 (Giovanni Caforio)。

Lamberto, Charlie, and Francis will have prepared remarks, and Giovanni is here as well to take any questions you might have.

蘭貝托、查理和弗朗西斯將準備好發言稿，喬瓦尼也會在這裡回答您可能提出的任何問題。

Before I turn the call over to Lamberto, let me cover off the legal requirements.

在我把電話轉給蘭貝託之前，讓我先介紹一下法律要求。

During the call, we will make comments or statements about the Company's future plans and prospects that constitute forward-looking statements.

在電話會議期間，我們將對公司的未來計劃和前景做出構成前瞻性陳述的評論或陳述。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Company's SEC filings.

由於各種重要因素（包括公司向 SEC 文件中討論的因素），實際結果可能與這些前瞻性陳述所示的結果存在重大差異。

These forward-looking statements represent our estimates as of today, and should not be relied upon as representing our estimates as of any subsequent date.

這些前瞻性陳述代表了我們截至目前的估計，不應被視為代表我們截至任何後續日期的估計。

We specifically disclaim any obligation to update forward-looking statements, even if our estimates change.

即使我們的估計發生變化，我們特別不承擔任何更新前瞻性陳述的義務。

We'll also discuss non-GAAP financial measures, adjusted to exclude certain specified items.

我們還將討論經過調整以排除某些特定項目的非公認會計準則財務指標。

Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available on our website.

我們的網站上提供了這些非公認會計準則財務指標與最具可比性的公認會計準則財務指標的調節表。

Lamberto?

蘭貝托？

Thank you, John.

謝謝你，約翰。

Good morning, everyone.

大家，早安。

Well, our fourth quarter completing year, a good year, it was very significant with respect to the evolution of Bristol-Myers Squibb into a specialty care biopharma company.

嗯，第四季度是我們完成的一年，是美好的一年，對於百時美施貴寶發展成為一家專業護理生物製藥公司來說非常重要。

We transitioned away from Plavix and Avapro.

我們放棄了 Plavix 和 Avapro。

We continued to grow our key brands.

我們繼續發展我們的主要品牌。

We shifted our strategic focus in early R&D, while advancing the nivolumab, the SD portfolio, and the rest of our late stage pipelines.

我們將戰略重點轉向早期研發，同時推進納武單抗、SD 產品組合和其他後期產品線。

We enhanced our geographical balance, and we initiated the sale of our diabetes business.

我們加強了地域平衡，並開始出售糖尿病業務。

Taken together these developments and changes not only set the stage for 2014, importantly they also represent the foundation of which we continue to build our future as a specialty care leader.

總而言之，這些發展和變化不僅為 2014 年奠定了基礎，更重要的是，它們也為我們繼續打造作為專業護理領導者的未來奠定了基礎。

I know, I know well, that everybody's attention is understandably on our immune oncology assets and programs.

我知道，我很清楚，每個人的注意力都集中在我們的免疫腫瘤學資產和項目上，這是可以理解的。

And so Charlie, Francis, and I will talk about them, and together with Giovanni, we will answer your questions.

因此，查理、弗朗西斯和我將討論這些問題，並與喬瓦尼一起回答你們的問題。

But I would like first to take a few minutes to speak about the rest, starting with the sum of our foundational products, all of which are growing in importance, and growing in terms of global reach.

但我想首先花幾分鐘談談其餘的事情，首先從我們的基礎產品的總和開始，所有這些產品的重要性都在增長，並且在全球影響力方面也在不斷增長。

Sprycel and Orencia both had a spectacular year.

Sprycel 和 Orencia 都度過了輝煌的一年。

Last quarter they grew by 30% and 22% respectively, despite very competitive markets.

儘管市場競爭非常激烈，但上個季度它們的增長率分別為 30% 和 22%。

For the full year, Sprycel sales increased 26% and those of Orencia increased 23%.

Sprycel 全年銷量增長 26%，Orencia 銷量增長 23%。

And for Sprycel, we presented important Phase III data in December at the American Society of Hematology.

對於 Sprycel，我們於 12 月在美國血液學會公佈了重要的 III 期數據。

Also Baraclude had a strong performance, with 10% growth for the year and 14% during the fourth quarter.

博路定也表現強勁，全年增長 10%，第四季度增長 14%。

As we moved into 2014, we will continue to invest behind these three actors: Sprycel, Orencia, and Baraclude.

進入 2014 年，我們將繼續對這三位演員進行投資：Sprycel、Orencia 和 Bararude。

We also remain firmly committed, very committed, to Eliquis, and together with Pfizer have decided to increase our resources behind it.

我們仍然堅定地致力於 Eliquis，並與輝瑞一起決定增加其背後的資源。

We have been seeing encouraging trends for Eliquis in the US and internationally with strong growth in the last quarter, and we are confident in its potential.

我們看到 Eliquis 在美國和國際上的令人鼓舞的趨勢，上個季度出現強勁增長，我們對其潛力充滿信心。

And we are also hoping to expand the label of Eliquis.

我們也希望擴大 Eliquis 的品牌。

In Europe, DVT prevention has already been approved, and we are expecting approval for VTE treatment as well.

在歐洲，DVT 預防已獲得批准，我們也期待 VTE 治療獲得批准。

In the US, we are expecting approval for both indications this year.

在美國，我們預計這兩種適應症今年都會獲得批准。

And finally to complete my comments on key market brands, our immune oncology product, Yervoy, had a strong year with 36% growth.

最後，為了完成我對主要市場品牌的評論，我們的免疫腫瘤產品 Yervoy 表現強勁，增長了 36%。

Based on the strong performance as well as the long-term survival data we presented last year, we increasingly believe in the transformational potential of Immunotherapy, and Yervoy as the cornerstone of that approach.

基於我們去年提供的強勁表現以及長期生存數據，我們越來越相信免疫療法的變革潛力，而 Yervoy 是該方法的基石。

On the regulatory and clinical development front, I've already mentioned the development for Eliquis.

在監管和臨床開發方面，我已經提到了 Eliquis 的開發。

In the Hepatitis C area in Japan we filed late last year our dual regimen containing daclatasvir in our protase inhibitor, asunaprevir.

在日本的丙型肝炎領域，我們去年年底提交了在我們的蛋白酶抑製劑 asunaprevir 中含有 daclatasvir 的雙重治療方案。

I hope we will soon get trade names here, it's easier to pronounce its generic names, which will give us the opportunity to bring the first oral Hepatitis C regimen to market in Japan.

我希望我們很快就能在這裡得到商品名稱，它的通用名稱更容易發音，這將使我們有機會將第一個口服丙型肝炎治療方案推向日本市場。

We also recently announced the filing of daclatasvir in Europe, and we expect to file in the US by midyear.

我們最近還宣佈在歐洲提交達卡他韋的申請，預計將於年中在美國提交申請。

Francis will talk soon about our good achievements and exciting plans in immuno-oncology where we want to achieve and maintain a leadership position.

弗朗西斯很快將談論我們在免疫腫瘤學方面取得的良好成就和令人興奮的計劃，我們希望在該領域取得併保持領先地位。

Taken as a whole, I'm optimistic about our business and the opportunities that we have.

總的來說，我對我們的業務和我們擁有的機會感到樂觀。

[We will] mention the diabetes transition, and all of the other many changes we are implementing while executing against a number of operational priorities, namely building on the launch of Eliquis and on the double digit growth of Yervoy, Orencia, Sprycel, and Baraclude.

[我們將]提到糖尿病轉型，以及我們在針對許多運營優先事項執行的同時正在實施的所有其他許多變革，即以 Eliquis 的推出以及 Yervoy、Orencia、Sprycel 和 Bararude 的兩位數增長為基礎。

Continuing the good performance of our other in-line brands, such as Rayataz and Sustiva, investing to deliver our late-stage immuno-oncology, oncology, and [active] pipeline, and launching new products, and continuing to take a disciplined approach to capital allocation.

繼續我們其他一線品牌（例如 Rayataz 和 Sustiva）的良好表現，投資提供我們的後期免疫腫瘤學、腫瘤學和[活躍]管道，並推出新產品，並繼續採取嚴格的方法資本配置。

In so doing, we will continue to pursue the balanced approach that is at the center of Bristol-Myers Squibb's success, the balanced approach of delivering today while setting the stage for tomorrow.

在此過程中，我們將繼續追求百時美施貴寶成功核心的平衡方法，即在實現今天目標的同時為明天奠定基礎。

So with that, let me turn it over to Francis to talk about immuno-oncology.

那麼，讓我把它交給弗朗西斯來談談免疫腫瘤學。

Thank you Lamberto, and good morning everyone.

謝謝蘭貝托，大家早上好。

Today I'll provide an update on immuno-oncology.

今天我將提供免疫腫瘤學的最新進展。

During the fourth quarter we presented some early but encouraging data in lung cancer at the World Conference on Lung Cancer.

第四季度，我們在世界肺癌大會上展示了一些早期但令人鼓舞的肺癌數據。

Long-term follow-up results in the lung cancer cohort of the expanded Phase I dose ranging monotherapy study, that's 003, showed sustained activity in heavily pretreated patients with non-small cell lung cancer with one- and two-year survival rates of 42% and 24% respectively, across the dose's cohorts.

擴展的 I 期劑量範圍單藥治療研究 (即 003) 的肺癌隊列的長期隨訪結果顯示，經過大量預先治療的非小細胞肺癌患者俱有持續的活性，一年和兩年生存率為 42在各劑量組中，分別為 % 和 24%。

These early data support our approach and belief that durability of response and long-term survival are important measures for patients, and are key in characterizing the benefits of immuno-oncology agents.

這些早期數據支持我們的方法和信念，即反應的持久性和長期生存是患者的重要衡量標準，並且是描述免疫腫瘤藥物益處的關鍵。

We expect to present updated data for lung cancer and other tumor types at AASCO this year.

我們預計今年將在 AASCO 上展示肺癌和其他腫瘤類型的最新數據。

Let me broadly review our strategy in lung cancer.

讓我大致回顧一下我們在肺癌方面的策略。

Our approach in lung cancer is to include multiple lines of therapy, different histologies, the use of biomarkers, and potentially therapy with monotherapy and combinations; all of which together results in a very comprehensive development program.

我們治療肺癌的方法是包括多種療法、不同的組織學、生物標誌物的使用，以及潛在的單一療法和聯合療法；所有這些共同形成了一個非常全面的發展計劃。

We expect to have data in the first part of 2014 from our third-line Phase II study in squamous non-small cell lung cancer for which there is no defined standard of care.

我們預計將在 2014 年上半年獲得鱗狀非小細胞肺癌三線 II 期研究的數據，目前尚無明確的治療標準。

As we've said before, if the results of the study demonstrate a favorable benefit/risk profile, we plan to discuss the data with the FDA and other health authorities.

正如我們之前所說，如果研究結果顯示出良好的效益/風險狀況，我們計劃與 FDA 和其他衛生當局討論這些數據。

We expect to have data later in 2014 from two ongoing second-line Phase III trials in non-small cell lung cancer, one in squamous and one in non-squamous.

我們預計將在 2014 年晚些時候獲得兩項正在進行的非小細胞肺癌二線 III 期試驗的數據，一項針對鱗狀細胞肺癌，另一項針對非鱗狀細胞肺癌。

And finally, as many of you have seen, we recently posted on clintrials.gov a first-line Phase III trial with nivolumab monotherapy in lung cancer that we will start soon.

最後，正如你們許多人所看到的，我們最近在 clintrials.gov 上發布了一項針對肺癌的納武單抗單藥療法一線 III 期試驗，我們很快就會開始。

With regard to the Phase I combination trial of nivolumab and ipilimumab, it's worth noting this is a Phase I trial that's still ongoing in multiple cohorts of patients and with several dose combinations being evaluated to determine how we could move forward with a combination regimen for lung cancer.

關於 nivolumab 和 ipilimumab 的 I 期聯合試驗，值得注意的是，這是一項 I 期試驗，仍在多個患者隊列中進行，並且正在評估幾種劑量組合，以確定我們如何推進肺部聯合治療方案癌症。

Based on our assessment of the preliminary data that we now have in-house, we will continue the cohorts of patients with lung cancer treated with ipilimumab and nivolumab combinations before beginning a registrational study.

根據我們對內部現有初步數據的評估，我們將在開始註冊研究之前繼續使用伊匹單抗和納武單抗聯合治療的肺癌患者隊列。

Our next steps include awaiting more mature data from additional cohorts in the study, and potentially exploring different doses and regimens and specific patient populations.

我們的下一步包括等待研究中其他隊列的更成熟數據，並可能探索不同的劑量和方案以及特定的患者群體。

In summary, in lung cancer we continue to progress a very comprehensive program that will generate important data from three potentially registrational trials during 2014.

總之，在肺癌方面，我們繼續推進一項非常全面的計劃，該計劃將從 2014 年期間的三項潛在註冊試驗中生成重要數據。

In addition, we continue to explore combinations, as well as initiating the first-line Phase III monotherapy study that I mentioned earlier.

此外，我們還在繼續探索組合療法，並啟動我之前提到的一線III期單藥治療研究。

Our melanoma program is ongoing with three potentially registrational trials currently underway.

我們的黑色素瘤項目正在進行中，目前正在進行三項潛在的註冊試驗。

One in Yervoy failures and the other two in previously untreated patients as monotherapy and in combination with Yervoy, with a focus on demonstrating value through survival benefits.

一項針對 Yervoy 失敗，另外兩項針對既往未經治療的患者，作為單一療法或與 Yervoy 聯合治療，重點是通過生存獲益來證明價值。

In renal cell cancer, our Phase III trial is focused on metastatic disease comparing nivolumab to everolimus in patients who have received prior therapy.

在腎細胞癌中，我們的 III 期試驗重點是在既往接受過治療的患者中比較納武單抗和依維莫司的轉移性疾病。

Earlier trials are exploring the potential role of biomarkers in this tumor type, as well as nivolumab combinations in first-line renal cell cancer.

早期試驗正在探索生物標誌物在這種腫瘤類型中的潛在作用，以及納武單抗組合在一線腎細胞癌中的潛在作用。

We have some initial data from Phase I study of nivolumab and Yervoy.

我們從 nivolumab 和 Yervoy 的 I 期研究中獲得了一些初步數據。

We're encouraged by the results, which we plan to present at AASCO.

我們計劃在 AASCO 上展示這些結果，這讓我們深受鼓舞。

And we believe that we are close to determining a dosing schedule to use in registrational trials.

我們相信我們即將確定用於註冊試驗的給藥方案。

In addition to nivolumab programs I've already highlighted, we continue to explore its use in additional solid tumor types and in hematological malignancies.

除了我已經強調過的納武單抗項目外，我們還繼續探索其在其他實體瘤類型和血液惡性腫瘤中的應用。

As you may have seen in clinicaltrials.gov, we are initiating large phase II trials in clear blastoma and in both follicular and diffuse large B-cell lymphoma.

正如您可能在 ClinicalTrials.gov 中看到的，我們正在啟動針對透明母細胞瘤以及濾泡性和瀰漫性大 B 細胞淋巴瘤的大型 II 期試驗。

We also have a broad portfolio of exploratory immunotherapeutic agents with varying immune mechanisms of action that allow us to explore multiple combinations, including our Anti-LAG-3 antibody, which entered the clinic in the last quarter.

我們還擁有廣泛的探索性免疫治療藥物組合，具有不同的免疫作用機制，使我們能夠探索多種組合，包括我們的抗 LAG-3 抗體，該抗體於上季度進入臨床。

So in closing, let me reiterate our excitement about the possibilities in immuno-oncology.

最後，讓我重申我們對免疫腫瘤學的可能性感到興奮。

I believe that we are well positioned with a broad and comprehensive program.

我相信我們已經做好了充分準備，制定了廣泛而全面的計劃。

I'm looking forward to seeing more data as the year progresses.

隨著時間的推移，我期待看到更多數據。

We'll certainly know a lot more about nivolumab a year from now.

一年後我們肯定會對納武單抗有更多了解。

At the same time, we'll continue to invest significantly in the multiple opportunities we see across our broader immuno-oncology portfolio.

與此同時，我們將繼續對我們在更廣泛的免疫腫瘤學產品組合中看到的多種機會進行大量投資。

Now, let me turn it over to Charlie.

現在，讓我把它交給查理。

Thank you Francis, and good morning everyone.

謝謝弗朗西斯，大家早上好。

Overall, we had a solid fourth quarter, which gives us the strong foundation for our future as a specialty care biopharma company.

總體而言，我們第四季度的業績表現強勁，這為我們作為一家專業護理生物製藥公司的未來奠定了堅實的基礎。

Let me provide a few highlights.

讓我提供一些亮點。

Yervoy sales grew 23% to $260 million.

Yervoy 銷售額增長 23%，達到 2.6 億美元。

In the US, quarterly demand reached its highest level since launch, and we are seeing encouraging weekly trends as well.

在美國，季度需求達到了推出以來的最高水平，我們也看到了令人鼓舞的每週趨勢。

Despite the multiple clinical trials enrolling melanoma patients, US sales rose 14% from the previous quarter to $148 million.

儘管開展了多項招募黑色素瘤患者的臨床試驗，但美國銷售額仍較上一季度增長 14%，達到 1.48 億美元。

We are seeing particularly strong growth in the community setting, which represents about 60% of Yervoy sales in the US, as a growing number of physicians appreciate Yervoy's long-term survival benefit.

隨著越來越多的醫生認識到 Yervoy 的長期生存益處，我們看到社區環境的增長尤其強勁，社區環境約佔 Yervoy 在美國銷售額的 60%。

In Europe, we are seeing strong uptake, particularly in France, Italy, and Germany.

在歐洲，我們看到了強勁的增長勢頭，特別是在法國、意大利和德國。

We expect the November EU approval for the first-line use in advanced melanoma to allow a broader set of patients to benefit from this innovative medicine.

我們預計 11 月歐盟將批准其用於晚期黑色素瘤的一線治療，以使更廣泛的患者受益於這種創新藥物。

Eliquis sales were $71 million.

Eliquis 銷售額為 7100 萬美元。

We continue to make significant progress among cardiologists.

我們繼續在心髒病專家中取得重大進展。

Overall in the US, access is in a much better position as we enter 2014 for both commercial and Medicare Part D plans.

總體而言，在美國，隨著進入 2014 年，商業和 Medicare D 部分計劃的准入狀況要好得多。

Eliquis also performed well outside the US, with international sales reaching $23 million in the quarter.

Eliquis 在美國以外的市場也表現出色，本季度國際銷售額達到 2300 萬美元。

Following several key reimbursement decisions in Q4, Eliquis is now available and reimbursed in every major market in Europe.

繼第四季度的幾項關鍵報銷決定之後，Eliquis 現已在歐洲每個主要市場提供並報銷。

Our increased medical education activities and DTC advertising, which will continue in 2014, are helping us educate physicians about Eliquis' differentiated profile.

我們將在 2014 年繼續開展更多的醫學教育活動和 DTC 廣告，幫助我們向醫生宣傳 Eliquis 的差異化形象。

We will be making additional investments this year as we prepare for potential expanded indications in VTE prevention and treatment.

今年我們將進行額外投資，為 VTE 預防和治療方面潛在的擴大適應症做準備。

Orencia sales grew 22% to $397 million.

Orencia 銷售額增長 22%，達到 3.97 億美元。

Orencia continues to perform well in the US and Europe, even as the RA market becomes increasingly crowded.

儘管 RA 市場變得越來越擁擠，Orencia 在美國和歐洲仍然表現良好。

Growth of the sub-Q formulation has been strong for several quarters, and we are also investing appropriately to continue driving the IV business.

sub-Q 配方的增長在幾個季度中一直強勁，我們也在適當投資以繼續推動 IV 業務。

Orencia sub-Q is now the third most widely prescribed sub-Q agent in the US, with sales up 51% versus the prior year's quarter.

Orencia sub-Q 目前是美國第三大處方最廣泛的 sub-Q 藥物，銷售額比去年同期增長了 51%。

Sales growth in Europe was also (technical difficulties) the sub-Q launch.

歐洲的銷售增長也是（技術困難）次Q推出的。

Baraclude sales grew 14% to $412 million.

博路定銷售額增長 14%，達到 4.12 億美元。

Sales were strong across the globe.

全球銷售強勁。

Despite growing competition, Baraclude remains the standard of care in naive patients in chronic Hepatitis B, and is of particular importance in Asia due to the epidemiology.

儘管競爭日益激烈，博路定仍然是慢性乙型肝炎初治患者的護理標準，並且由於流行病學原因，在亞洲尤其重要。

Our success with Baraclude demonstrates our ability to leverage our expertise in virology to develop and commercialize innovative medicines at a global level, a capability that is important in establishing our Hepatitis C portfolio.

我們與博路定的成功證明了我們有能力利用我們在病毒學方面的專業知識在全球範圍內開發和商業化創新藥物，這一能力對於建立我們的丙型肝炎產品組合非常重要。

Sprycel sales rose 30% to $365 million.

Sprycel 銷售額增長 30%，達到 3.65 億美元。

We continue to see sales growth being driven by sustained adoption in the first-line setting, as well as by our leading share in the second-line segment.

我們繼續看到銷售增長是由一線環境的持續採用以及我們在二線市場的領先份額推動的。

In addition to the solid sales performance of our key brands, revenues benefited from several one-time items, including a $38 million adjustment to our managed Medicaid accrual, mostly for Plavix, as well as a $30 million year-end true-up of our share of Atripla revenues.

除了我們主要品牌的穩健銷售業績外，收入還受益於多項一次性項目，包括對我們管理的醫療補助應計項目進行 3800 萬美元的調整（主要是針對 Plavix），以及對我們的管理醫療補助應計項目進行 3000 萬美元的年終調整。 Atripla 收入的份額。

To wrap up sales, you are all aware that we expect this will be the list time we report a full quarter of sales for the diabetes franchise, due to the expected closing of the diabetes divestiture to AstraZeneca later this quarter.

為了總結銷售，大家都知道，我們預計這將是我們報告糖尿病特許經營業務整個季度銷售的上市時間，因為預計本季度晚些時候將完成對阿斯利康的糖尿病業務剝離。

Moving forward we expect that substantially all royalties we receive will be included on the other income and expense line.

展望未來，我們預計我們收到的幾乎所有特許權使用費都將計入其他收入和支出項目。

Now, let me highlight a few items from the rest of our non-GAAP P&L.

現在，讓我重點介紹我們其餘非公認會計準則損益表中的一些項目。

Gross margin was 73.6% during the quarter, which is down 280 basis points compared to the same period last year.

該季度毛利率為73.6%，較去年同期下降280個基點。

This is mostly due to the change in our contracted share of Abilify revenues in the US, and to a lesser extent product mix.

這主要是由於我們在美國的 Abilify 收入合同份額的變化，以及較小程度上的產品組合的變化。

Gross margin also benefited from some of the one-time items that impacted revenues as well.

毛利率也受益於一些影響收入的一次性項目。

Marketing, selling, and admin expenses were about $1.1 billion, down 7%, as our increased investments in Eliquis, the diabetes franchise, and pre-launch assets in immuno-oncology and Hep C were offset by steeper declines in the pharmacy, our share of expenses for Abilify, and lower spending on more mature brands.

營銷、銷售和管理費用約為 11 億美元，下降 7%，因為我們對 Eliquis、糖尿病專營權以及免疫腫瘤學和丙肝上市前資產的投資增加，但被藥房的急劇下降所抵消，我們的份額Abilify 的支出減少，而更成熟品牌的支出減少。

Our non-GAAP tax rate was 17.9% during the quarter.

本季度我們的非 GAAP 稅率為 17.9%。

Moving to guidance.

轉向指導。

We are confirming our non-GAAP EPS guidance range of $1.65 to $1.80.

我們確認非 GAAP 每股收益指導範圍為 1.65 美元至 1.80 美元。

Both our GAAP and non-GAAP guidance assumed that the sale of the diabetes business to AstraZeneca closes during the first quarter.

我們的公認會計原則和非公認會計原則指導均假設糖尿病業務向阿斯利康的出售將在第一季度完成。

We are not able to provide line item guidance at this time, but expect to be able to do so once the diabetes transaction has closed.

我們目前無法提供行項目指導，但預計在糖尿病交易結束後能夠提供。

This will happen during our Q1 call in April.

這將在四月份的第一季度電話會議期間發生。

Qualitatively, and as I've indicated previously, while total commercial costs in 2014 are expected to [decrease] compared to 2013 due to the diabetes transaction, we will be making significant incremental investments behind our key and future growth opportunities, including immuno-oncology, Eliquis, and Hep C.

就質量而言，正如我之前所指出的，雖然由於糖尿病交易，2014 年的總商業成本預計將比 2013 年有所下降，但我們將在關鍵和未來的增長機會背後進行大量增量投資，包括免疫腫瘤學、 Eliquis 和 Hep C.

Now, we would be happy to address your questions.

現在，我們很樂意回答您的問題。

Thanks, Charlie, Francis, and Lamberto.

謝謝查理、弗朗西斯和蘭貝托。

(Inaudible) and Shannon, I think we're ready to go to Q&A now.

（聽不清）香農，我想我們現在已經準備好進行問答了。

I'd just remind everybody that in addition to Lamberto, Francis, and Charlie, Giovanni is here as well.

我只是提醒大家，除了蘭貝托、弗朗西斯和查理之外，喬瓦尼也在這裡。

Shannon?

香農？

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

We'll go first to Tony Butler with Barclays.

我們首先請教巴克萊銀行的托尼·巴特勒。

Thanks very much.

非常感謝。

I'll leave immuno-oncology to others and ask about elotuzumab, Francis, and would we would anticipate that Phase III readout in relapsing patients and multiple myeloma to occur at AASCO?

我將把免疫腫瘤學留給其他人，並詢問 elotuzumab，Francis，我們是否會預期在 AASCO 進行複發患者和多發性骨髓瘤的 III 期試驗？

Second question is actually around, and I apologize for the second question, (technical difficulties) margins Charlie, and is there anything that you could say about that in the post-diabetes world?

第二個問題實際上已經存在，我對第二個問題（技術困難）感到抱歉，查理，關於後糖尿病世界，你有什麼可以說的嗎？

Thank you.

謝謝。

So there will be an update at AASCO, I believe, on the Phase II study on relaxin on -- sorry, on multiple myeloma at AASCO, but we were expecting data on the Phase III study later, of course.

因此，我相信 AASCO 將會有關於鬆弛素的 II 期研究的更新——抱歉，是 AASCO 的多發性骨髓瘤研究，但當然，我們期待稍後獲得 III 期研究的數據。

Yes, I think I understood your question, Tony, regarding gross margin moving forward.

是的，托尼，我想我理解你關於未來毛利率的問題。

Gross margin is always dependent upon product mix.

毛利率始終取決於產品組合。

And you recall that the diabetes business was a relatively low gross margin business because we paid the share of margin through the cost-of-goods line to AstraZeneca.

您還記得糖尿病業務是一項毛利率相對較低的業務，因為我們通過商品成本線向阿斯利康支付了利潤份額。

So we therefore expect our 2014 gross margin rate to benefit going forward.

因此，我們預計 2014 年毛利率將受益。

Again dependent upon the timing of close that may impact it, but I would imagine it's going to be in the neighborhood of slightly above 75%.

再次取決於可能影響它的關閉時間，但我想它會在略高於 75% 的範圍內。

Thanks, Tony, for the questions.

謝謝托尼提出的問題。

Can we go to the next question, Shannon?

我們可以進入下一個問題嗎，香農？

We'll move next to Tim Anderson with Sanford Bernstein.

我們將移至蒂姆·安德森（Tim Anderson）和桑福德·伯恩斯坦（Sanford Bernstein）旁邊。

Thank you very much.

非常感謝。

In the past, you've kind of described PDL and expression as maybe not being relevant, partly because the combination of nivo with other agents might make that assay not clinically meaningful, and at the same time in October at World Lung your data showed no real difference based on biomarker expression.

過去，您描述的 PDL 和表達可能不相關，部分原因是 nivo 與其他藥物的組合可能使該測定沒有臨床意義，同時 10 月份在 World Lung 的數據顯示沒有基於生物標誌物表達的真正差異。

Yet here you are now starting Checkmate 26.

然而，您現在正在啟動 Checkmate 26。

I'm trying to square why you're initiating this new trial.

我正在試圖弄清楚你為什麼要啟動這項新試驗。

And then can you tell us what percent of non-small cell patients are high expressors of PDL lung using your cutoff criteria?

然後您能否告訴我們，使用您的截止標準，非小細胞患者中 PDL 肺高表達者的百分比是多少？

If I look at the Merck and Roche data, it suggests maybe it's 25%.

如果我看一下默克和羅氏的數據，它表明可能是 25%。

And kind of building onto that, if PDL lung expression ends up being a predictive biomarker, wouldn't it be reasonable to assume that this could end up limiting the number of patients that would be deemed eligible for therapy?

在此基礎上，如果 PDL 肺部表達最終成為預測性生物標誌物，那麼假設這最終會限制被認為有資格接受治療的患者數量，難道不是合理的嗎？

Thank you, Tim.

謝謝你，蒂姆。

So let me say that, first of all to say that I'll starting a first-line study non-small cell lung biomarker rich is very consistent with our overall very broad lung strategy, as I just articulated.

因此，我要說的是，首先要說的是，我將開始一項富含非小細胞肺生物標誌物的一線研究，這與我們整體非常廣泛的肺部戰略非常一致，正如我剛才闡述的那樣。

In addition, I think we've always said in terms of a biomarker strategy that we would look very carefully at all patients, and we collect tumors from all patients, and we do PDL1 expression on that.

此外，我認為我們一直在生物標誌物策略方面說，我們會非常仔細地觀察所有患者，我們收集所有患者的腫瘤，並對其進行 PDL1 表達。

And our goal is to better understand the impact of PDL1 expression, not just on an overall response rate, but on overall survival.

我們的目標是更好地了解 PDL1 表達的影響，不僅對總體緩解率，而且對總體生存率的影響。

And while I think there has been this directional data that shows that PDL1 expression tends to be related to higher response rates, it's certainly by no means clear to all of us all the time, [that] we just don't have the data about whether that will hold for all lines of therapy and all different tumors.

雖然我認為有這些定向數據表明 PDL1 表達往往與較高的反應率相關，但我們所有人一直都不清楚，我們只是沒有相關數據這是否適用於所有療法和所有不同的腫瘤。

But I think in the case that of first line, it's very important for us in this study to enrich the patient population for this particular study.

但我認為就一線而言，在這項研究中豐富患者群體對於我們來說非常重要。

So, and as you are well aware, we have second-line studies ongoing where we are also collecting PDL1 expression data, and it's very important for us to try and offer opportunities for patients who aren't just PDL1 positive.

因此，正如您所知，我們正在進行二線研究，我們也在收集 PDL1 表達數據，對於我們來說，嘗試為 PDL1 陽性以外的患者提供機會非常重要。

So of course that will provide the data for that also.

當然，這也會提供相關數據。

I'm not going to comment on our particular percentages.

我不會評論我們的特定百分比。

Obviously, different biomarker, even histo-chemistry may be slightly different between different companies.

顯然，不同公司之間的不同生物標誌物，甚至組織化學可能略有不同。

But again I want to reiterate that our long-term aim in our lung cancer program is to offer, if the data supports it, the opportunity for all patients, whether it's PDL1 positive or negative, to have the opportunity of immuno-oncology treatment, whether it's monotherapy or combination.

但我想再次重申，我們肺癌項目的長期目標是，如果數據支持的話，為所有患者提供機會，無論是 PDL1 陽性還是陰性，都有機會接受免疫腫瘤治療，無論是單一療法還是聯合療法。

Thank you.

謝謝。

Thanks, Tim.

謝謝，蒂姆。

Next question please Shannon?

下一個問題請香農？

We'll move next to David Risinger with Morgan Stanley.

接下來我們將請摩根士丹利的大衛·瑞辛格 (David Risinger) 發言。

Thanks very much.

非常感謝。

So I have a question on PD1 for Francis.

我有一個關於 PD1 的問題要問 Francis。

I'm just hoping to better understand the assessment process you'll go through with Checkmate 12, and so I guess two specific questions on that.

我只是希望更好地了解您將使用 Checkmate 12 進行的評估過程，因此我想有兩個具體問題。

First, can you talk about the addition of the lower dose nivo plus ipi, 1 milligram plus 1 milligram cohort last Fall, and whether you really need to see those results before you can start nivo plus ipi Phase III combo in lung at some point down the line.

首先，您能否談談去年秋天添加較低劑量的 nivo 加 ipi（1 毫克加 1 毫克隊列），以及您是否真的需要看到這些結果才能在肺部某個時間點開始 nivo 加 ipi III 期組合線。

And then second, what data should we expect at AASCO from Checkmate 12, and also in other cancers beyond lung?

其次，我們應該在 AASCO 上從 Checkmate 12 中獲得哪些數據，以及肺癌以外的其他癌症的數據？

So David, let me say that we added the additional 1 milligram and 1 milligram cohort back in September to insure that we would have the full complement of safety and activity data across multiple doses.

David，讓我說一下，我們在 9 月份添加了額外的 1 毫克和 1 毫克隊列，以確保我們能夠獲得多個劑量的完整安全性和活性數據。

And as I said, we will be assessing that dose together with the potential other regimens and patient populations before we determine how to proceed into registrational studies with the combination.

正如我所說，在決定如何進行該組合的註冊研究之前，我們將與潛在的其他治療方案和患者群體一起評估該劑量。

Regarding the data at AASCO, there will be data in Checkmate 12, which on this combination of the different cohorts, depending on how it matures.

關於 AASCO 的數據，Checkmate 12 中也會有數據，這些數據是不同群體的組合，具體取決於它的成熟程度。

And just to remind you, of course, that this is an ongoing Phase I trial where we're going to continue the cohorts to collect data.

當然，只是想提醒您，這是一項正在進行的第一階段試驗，我們將繼續進行隊列收集數據。

So [they will] be updated at AASCO.

因此，[它們將]在 AASCO 上更新。

And there will also be data at AASCO on the 003 study, the update on that.

AASCO 還將提供有關 003 研究的數據及其更新。

There will also be an update on 004, which is the combination in melanoma, as well as data on the renal cell carcinoma, both our Phase II study and the data on the combination that I just talked about.

還會有關於 004 的更新，這是黑色素瘤的組合，以及腎細胞癌的數據，包括我們的 II 期研究和我剛才談到的組合的數據。

So it will be a considerable amount of information at AASCO across many of our ongoing trials, and some that you'll be hearing for the first time.

因此，AASCO 將提供大量關於我們正在進行的試驗的信息，其中一些是您第一次聽到的。

Thanks, Dave.

謝謝，戴夫。

Can we go to the next question, please?

我們可以進入下一個問題嗎？

We'll move next to Jami Rubin with Goldman Sachs.

我們將接替高盛的賈米·魯賓 (Jami Rubin)。

Thank you.

謝謝。

Francis, is there any question in your mind as to whether or not you move the combo lung into a Phase III trial, or is it just you're still assessing what you have the multiple cohorts in that trial, and at some point you'll make the decision?

弗朗西斯，對於是否將組合肺轉移到 III 期試驗，您是否有任何疑問，或者只是您仍在評估該試驗中的多個隊列，並且在某個時候您'會做出決定嗎？

But I'm just curious to know, is that a risk that you don't move forward at all with that?

但我只是想知道，這是否有你根本不繼續前進的風險？

And then secondly on the hematological indications, I notice you just started two Phase II studies.

其次，關於血液學指標，我注意到您剛剛開始了兩項二期研究。

Can you give us some sense as to your confidence level on that new indication?

您能否告訴我們您對這一新指標的信心程度？

I suppose that's based on the Phase I trials that you started last year.

我想這是基於你們去年開始的第一階段試驗。

And when do you think we will see data in hematological indications?

您認為我們什麼時候會看到血液學指標的數據？

Will it be some time this year?

今年會某個時候嗎？

And maybe if you could comment, too, on the markets been very focused on renal, lung, and melanoma.

也許您也可以評論一下，市場非常關注腎臟、肺和黑色素瘤。

What other tumor types are you guys most excited about?

你們最感興趣的其他腫瘤類型是什麼？

Thanks.

謝謝。

See if I make sure I get all those.

看看我是否確保得到所有這些。

So just to be clear, I don't think the data, we are indeed assessing the data before we can decide how to proceed into registration studies.

因此，需要明確的是，我不認為數據，我們確實正在評估數據，然後才能決定如何進行註冊研究。

I don't think the data to date changes our belief of the potential for combination somewhere in a broad lung program.

我不認為迄今為止的數據會改變我們對廣泛肺部計劃中某處組合潛力的信念。

I don't think we have the data to be sure exactly where that is at the moment, but that's evolving.

我認為我們目前還沒有數據來確定具體情況，但情況正在不斷發展。

As far as the hematological studies, the data that -- we will be presenting data at ASH later in the year on those exploratory hematological studies, and I think --

就血液學研究而言，我們將在今年晚些時候在 ASH 上展示這些探索性血液學研究的數據，我認為——

Yes, the tumors.

是的，腫瘤。

Yes.

是的。

So beyond those other tumors, as you know, we have a lot of exploratory studies at the moment.

如您所知，除了其他腫瘤之外，我們目前還有很多探索性研究。

I think I would say that we are very encouraged by the hematological.

我想我會說我們對血液學感到非常鼓舞。

That's the fact that we are studying some larger Phase II studies reflects, I think, our interest in that area.

事實上，我們正​​在研究一些更大規模的二期研究，我認為這反映了我們對該領域的興趣。

And of course, the unmet need around clear blastoma [forming] again is reflected in going forward with a study, both looking at seeing if monotherapy or combination there.

當然，圍繞明確母細胞瘤[形成]的未滿足需求再次反映在一項研究的進展中，這兩項研究都著眼於單一療法還是聯合療法。

Thank you.

謝謝。

Thanks, Jami.

謝謝，賈米。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

We'll move next to Seamus Fernandez with Leerink.

我們將與 Leerink 一起移至 Seamus Fernandez 旁邊。

Thanks for the questions.

感謝您的提問。

So again, not to continue on immuno-oncology but it is pretty important.

再說一次，不要繼續免疫腫瘤學，但它非常重要。

As we sort of think about the kidney cancer opportunity, particularly in combination, the bar in the front-line setting seems to be relatively high, at least in terms of response rates, and even the duration of effect.

當我們考慮腎癌的機會時，特別是在組合中，前線環境的標準似乎相對較高，至少在反應率甚至效果持續時間方面是如此。

So given the fact that your communication on the combination in kidney cancer appears to be a little bit better formed than your conclusion in lung cancer, can you just update us and maybe give us a little bit of your thoughts on the kind of benefit that you would hope to see from a front-line kidney cancer combination, given the current standard of care?

因此，考慮到您對腎癌聯合用藥的溝通似乎比您對肺癌的結論要好一些，您能否向我們介紹一下最新情況，也許給我們一些您對聯合用藥帶來的益處的想法？鑑於目前的護理標準，是否希望看到一線腎癌組合？

So, I think let me say that you'll have the opportunity to see the data when we share it at AASCO.

所以，我想我想說的是，當我們在 AASCO 分享這些數據時，您將有機會看到這些數據。

I --clearly, the bar is high for first-line treatment, but we are encouraged by the data we've seen, and in due course we will be initiating a trial, potentially registrational trial in renal cell.

顯然，一線治療的門檻很高，但我們對所看到的數據感到鼓舞，在適當的時候我們將啟動一項試驗，可能是腎細胞的註冊試驗。

And obviously we're going to be very thoughtful about which line of therapy that will be applicable to.

顯然，我們將非常仔細地考慮適用於哪種療法。

So I'd suggest you, Seamus, wait and see what we show at AASCO.

所以我建議你，Seamus，等著看我們在 AASCO 上展示的內容。

And I think that will be very informative.

我認為這將提供非常豐富的信息。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

We'll move next to Mark Schoenebaum of ISI Group.

接下來我們請 ISI 集團的 Mark Schoenebaum 發言。

Hello, guys.

大家好。

Thanks a lot for taking the question, and thanks for tolerating all of us pounding on Immunotherapy.

非常感謝您提出這個問題，也感謝您容忍我們所有人對免疫療法的研究。

I think I might do the same.

我想我也可以這樣做。

I appreciate it.

我很感激。

Are you able to tell us in any qualitative sense, Francis, whether or not you saw enhanced efficacy in one or more of the Yervoy plus nivo arms in the 001/2 trial, just in any kind of qualitative sense?

弗朗西斯，您能否從任何定性意義上告訴我們，您是否在 001/2 試驗中看到一種或多種 Yervoy 加 nivo 臂的功效增強，只是在任何一種定性意義上？

I interpreted your remarks, you're continuing those arms as a remark reflecting some optimism.

我對你的言論進行了解讀，你繼續這些武器是一種反映樂觀情緒的言論。

But I was just wondering if you could just confirm that there was, to some degree, enhanced efficacy.

但我只是想知道你是否可以確認在某種程度上，功效得到了增強。

And obviously we'll wait to get the details.

顯然我們會等待了解細節。

And then on the world lung data, this will be the last question from me.

關於世界肺部數據，這將是我的最後一個問題。

On the world lung data, I know it was awhile ago now, but I'm not sure I've ever gotten your perspective on this.

關於世界肺部數據，我知道那是不久前的事了，但我不確定我是否了解過您對此的看法。

But the one-year 42% survival, but especially the two-year, 24% overall survival.

但一年生存率為 42%，尤其是兩年，總體生存率為 24%。

What is your view on that 24% number in particular versus what one would expect typically?

與人們通常的預期相比，您對 24% 的數字有何看法？

Thanks a lot.

多謝。

I really (technical difficulties).

我真的（技術困難）。

Mark, while Francis gets ready to answer your question, this is Lamberto.

馬克，當弗朗西斯準備回答你的問題時，這是蘭貝托。

Let me tell you that this morning John and others have asked me to keep quiet during this call and be very understanding of the importance of immuno-oncology and the number of questions that are going to be asked today.

讓我告訴你，今天早上約翰和其他人要求我在這次電話會議中保持安靜，並充分了解免疫腫瘤學的重要性以及今天要問的問題數量。

So it is important.

所以這很重要。

We understand the volume of immuno-oncology and the volume immuno-onclogy to Bristol-Myers Squibb.

我們了解免疫腫瘤學的規模以及百時美施貴寶的免疫腫瘤學的規模。

So we will be -- we are very open to answer questions, but obviously we cannot always go into very many details.

因此，我們非常願意回答問題，但顯然我們不能總是討論很多細節。

But you would be interested in knowing, but it is probably premature for us to disclose.

但你可能有興趣知道，但我們現在透露可能還為時過早。

And again, we will continue to make available as many comments as possible, but we will try to stay away from commenting on bits and pieces of information.

再次強調，我們將繼續提供盡可能多的評論，但我們將盡量避免對零碎的信息進行評論。

And we remain very, very proud of the breadth of our program and importance of what we are doing here.

我們仍然對我們計劃的廣度和我們在這裡所做的事情的重要性感到非常非常自豪。

And now Francis, back to you.

現在弗朗西斯，回到你身邊。

So I won't comment anymore on the ipi/nivo combination in Checkmate 12.

所以我不會再評論 Checkmate 12 中的 ipi/nivo 組合。

But just to your point about the world lung data, I think we said it at the time, and I'll say it again, we're encouraged about that.

但就你關於世界肺部數據的觀點而言，我想我們當時就說過了，我會再說一遍，我們對此感到鼓舞。

That's survival data, the landmark survival data at two years, particularly because it was across all doses.

這是生存數據，具有里程碑意義的兩年生存數據，特別是因為它涵蓋了所有劑量。

I missed the end of your question, but I think what you were asking was how that might relate to other studies we have ongoing.

我錯過了你問題的結尾，但我認為你問的是這與我們正在進行的其他研究有何關係。

And I think it's fair to say that it's very difficult to extrapolate, simply because the patient populations are quite different.

我認為可以公平地說，很難推斷，因為患者群體差異很大。

So let me stop there.

那麼讓我就此打住吧。

This is Giovanni.

這是喬瓦尼。

The only thing I would add is clearly lung, if you compare it to more to [melanoma], is a much larger population of patient, very diverse population of patients.

我唯一要補充的是，如果你將它與[黑色素瘤]進行比較，顯然肺部是一個更大的患者群體，非常多樣化的患者群體。

The unmet medical need is very high, and you know all of the therapies and combinations approaches that have failed over the last many years.

未滿足的醫療需求非常高，而且您知道過去多年來所有的療法和組合方法都失敗了。

So we see that as a very significant opportunity, and given the size and (technical difficulties) there is a significant commercial opportunity when looking differentially at different segments in lung, not only first line, but also later lines of therapy, different histologies and different patient groups.

因此，我們認為這是一個非常重要的機會，考慮到規模和（技術困難），當對肺的不同部分進行差異化觀察時，不僅是一線治療，而且還包括後續治療線、不同的組織學和不同的治療，這是一個重要的商業機會。患者群體。

They are all very meaningful commercial opportunities, even when you look at them independently.

即使你獨立地看待它們，它們都是非常有意義的商業機會。

Thanks, Mark.

謝謝，馬克。

Can we go to the next question, please?

我們可以進入下一個問題嗎？

We'll move next to Andrew Baum with Citi.

我們將移至花旗銀行的安德魯·鮑姆 (Andrew Baum) 旁邊。

Yes, good morning.

是的，早上好。

Couple of questions.

有幾個問題。

To what extent do the emergent immunodiagnostic enable you to select out a group of patient for whom the combination makes sense, both from a safety point of view as well as from an efficacy point of view?

無論是從安全角度還是從功效角度來看，新興免疫診斷在多大程度上使您能夠選擇出一組對聯合用藥有意義的患者？

Second question is, perhaps you can give us some timelines on when you think you may be able to initiate the Phase III trial for the combination?

第二個問題是，也許您可以給我們一些時間表，說明您何時可以啟動該組合的 III 期試驗？

And then finally, with regards to the choice of a PDL1 population for your Phase III, to what extent does PDL1 expression increase after subsequent lines of therapy, i.e., you need to enrich in the front line because treatment naive patients may have lower levels of PDL1 expression compared to patients who have got chemo radiant therapy.

最後，關於 III 期 PDL1 群體的選擇，後續治療後 PDL1 表達增加到什麼程度，即，您需要豐富前線，因為未經治療的患者可能具有較低水平的 PDL1 表達。與接受化療放療的患者相比，PDL1 的表達情況。

Is there any evidence for that in lung?

肺部有證據表明這一點嗎？

So just to go back to your first question is about how we selected the combination based on the diagnostic.

所以回到你的第一個問題是關於我們如何根據診斷選擇組合。

I think as I mentioned, we are collecting information in both PDL1 positive and PDL1 negative patients.

我認為正如我所提到的，我們正在收集 PDL1 陽性和 PDL1 陰性患者的信息。

And of course that's part of the assessment, at least in these preliminary studies to try and understand where the safety and efficacy goes as far as that's concerned.

當然，這是評估的一部分，至少在這些初步研究中是為了嘗試了解安全性和有效性。

I'm not going to talk about the timelines of the potential progression in the combination of lung, simply because, as I said, the trial is still ongoing, we're still assessing the data.

我不會談論肺結合的潛在進展的時間表，只是因為，正如我所說，試驗仍在進行中，我們仍在評估數據。

And of course it will depend on that data as to what we do next.

當然，我們下一步做什麼將取決於這些數據。

I think it's a good question about what does line of therapy do to the PDL1 expression, and certainly we are collecting that data to try and understand that better.

我認為這是一個很好的問題，關於治療線對 PDL1 表達有何作用，當然我們正在收集這些數據以嘗試更好地理解這一點。

I don't think we have that information laid out at the moment, but I do think it will be important to see.

我認為我們目前還沒有提供這些信息，但我確實認為了解這些信息很重要。

And of course we do have the opportunity because we're looking very broadly, first of all across lung, but actually against many other tumors as well, to try and begin to understand some of the kinetics of PDL1 expression, both with other non-I/O therapies and with I/O therapies.

當然，我們確實有機會，因為我們的目光非常廣泛，首先是肺部，但實際上也針對許多其他腫瘤，嘗試並開始了解 PDL1 表達的一些動力學，無論是與其他非腫瘤I/O 療法和 I/O 療法。

Thank you.

謝謝。

Thanks, Andrew.

謝謝，安德魯。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

We'll go next to Marc Goodman with UBS.

接下來我們將討論瑞銀集團的馬克·古德曼 (Marc Goodman)。

First on Eliquis in the US, obviously a big jump from last quarter to this quarter.

首先是美國的 Eliquis，從上季度到本季度顯然有很大的躍升。

I was curious, is that all demand, or was there anything else going on in the quarter?

我很好奇，這就是所有需求嗎？還是本季度還發生了其他事情？

Second on Sprycel, obviously very strong growth there.

其次是 Sprycel，顯然那裡的增長非常強勁。

Can you give us a sense of what's going on behind the scenes with market share?

您能否讓我們了解一下市場份額的幕後情況？

Is that where the growth is coming from, or what would you attribute it to?

這是增長的來源嗎？或者你將其歸因於什麼？

And then on Hep C in Japan, you had mentioned, obviously we know that you filed already, where is your expectation for when that will be approved in Japan and start to have sales?

然後，關於日本的 Hep C，您提到，顯然我們知道您已經提交了申請，您對日本何時批准並開始銷售有何預期？

Do you assume sales in your guidance for this year?

您在今年的指導中是否假設了銷售額？

Giovanni, why don't you take all three questions.

喬瓦尼，你為什麼不回答所有三個問題呢？

Let me start from the performance of Eliquis.

讓我從Eliquis的表現開始吧。

We had a strong quarter in Q4.

我們在第四季度表現強勁。

That was clearly true in the US.

這在美國顯然是正確的。

We had good developments outside of the US as well.

我們在美國以外的地區也取得了良好的發展。

With respect to the US, what you saw in terms of the numbers broadly reflects an improvement in performance and demand.

就美國而言，您所看到的數字廣泛反映了性能和需求的改善。

And when you look at TRX growth in the US in Q4, our TRX volume grew by 66%.

當你觀察第四季度美國 TRX 的增長時，我們的 TRX 數量增長了 66%。

Our NBRX volume grew by 50% versus the previous quarter, and we saw a good increase in shares, particularly in the cardiology setting.

我們的 NBRX 交易量比上一季度增長了 50%，並且我們看到份額大幅增長，尤其是在心髒病領域。

So I would say that the performance is really related to demand, and it is the result of the acceleration plan that we have put in place beginning in August, which we discussed before, which was really centered on strengthening and focusing our strategy and messages, significantly increasing our investment in medical education; and third, initiating in September a very broad DTC campaign in the US.

所以我想說，業績確實與需求相關，這是我們從 8 月份開始實施的加速計劃的結果，我們之前討論過該計劃，該計劃的真正重點是加強和集中我們的戰略和信息，大幅增加對醫學教育的投資；第三，9 月份在美國發起了一場非常廣泛的 DTC 活動。

All of those things seem to have had an impact on performance, and Q4 was a good quarter.

所有這些事情似乎都對業績產生了影響，第四季度是一個不錯的季度。

With respect to Sprycel, we do have very strong performance and good trends across the world.

就 Sprycel 而言，我們在全球範圍內確實擁有非常強勁的業績和良好的趨勢。

In the US, in Europe we had a very, very good quarter in Japan as well.

在美國、歐洲，我們在日本也度過了非常非常好的季度。

And that is coming from two things.

這是來自兩件事。

First of all, from a total market perspective, we continue to see a decline in the use of Gleevec and the growth of the second generation TKIs.

首先，從整個市場角度來看，我們繼續看到格列衛的使用量下降，而第二代TKI的使用量增長。

Among second generation TKI's, particularly in the US, in the last quarter Sprycel was the fastest growing agent, and we continue to have a leadership position in first line and the second line across -- among the second generation TKIs.

在第二代 TKI 中，特別是在美國，上個季度 Sprycel 是增長最快的藥物，並且我們在第二代 TKI 中繼續在一線和二線領域保持領導地位。

We have a strong presence in second line, but a lot of our growth is really coming from increased penetration and increased market share in first line.

我們在二線市場擁有強大的影響力，但我們的大部分增長實際上來自一線滲透率的提高和市場份額的增加。

With respect to Japan and Hepatitis C, we communicated where we are from a regulatory perspective.

關於日本和丙型肝炎，我們從監管角度溝通了我們的情況。

All I can say from a commercial perspective is that we are working as a priority to be ready for launch when we get approval.

從商業角度來看，我只能說，我們正在優先考慮在獲得批准後為發布做好準備。

Obviously, we will be executing very rapidly the launch in Japan.

顯然，我們將非常迅速地在日本推出產品。

Thanks, Marc.

謝謝，馬克。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

The next question is from Chris Schott with JP Morgan.

下一個問題來自摩根大通的克里斯·肖特。

Great, thanks very much.

太好了，非常感謝。

Just two ones coming back on nivo.

只有兩個人回到 nivo。

First, on the lung combo.

首先，關於肺部組合。

Should we think about additional cohorts being added to Checkmate 12 based on this data that you've recently received?

我們是否應該根據您最近收到的數據考慮將更多群組添加到 Checkmate 12 中？

Or at this point are we just really waiting for data from the existing cohorts before making a decision on potentially moving that forward?

或者說，在這一點上，我們是否真的只是在等待現有群體的數據，然後再做出是否可能向前推進的決定？

And the second question was on nivo with Avastin.

第二個問題是關於 nivo 和 Avastin 的。

Is that something you've seen at this point, and how are you thinking about the potential of the use of Avastin with nivo in lung?

這是您目前所看到的嗎？您如何看待阿瓦斯汀與尼沃在肺部使用的潛力？

Thanks very much.

非常感謝。

So as far as the lung combo cohorts, it is possible we may add more cohorts, Chris, but that's under consideration.

因此，就肺部組合隊列而言，我們可能會添加更多隊列，克里斯，但這正在考慮中。

And I think I would say just a general comment about combinations, while obviously we focus very much on immuno-oncology combinations, we haven't certainly ruled out having combinations where we feel it's appropriate and there could be some benefit.

我想我想說的只是對組合的一般性評論，雖然顯然我們非常關注免疫腫瘤學組合，但我們並沒有完全排除在我們認為合適並且可能有一些好處的情況下進行組合。

Thanks, Chris.

謝謝，克里斯。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

We'll go next to Vamil Divan with Credit Suisse.

接下來我們將前往瑞士信貸銀行 (Credit Suisse) 的瓦米爾迪萬 (Vamil Divan)。

Thanks for taking the question.

感謝您提出問題。

Just to clarify on thing for me.

只是為了幫我澄清一下事情。

In terms of the Checkmate 063 data, is that something you have in-house at this point?

就 Checkmate 063 數據而言，目前你們內部有這些數據嗎？

And I know, I think you mentioned before, because it may be registrational, that we get a top line press release on that.

我知道，我想你之前提到過，因為這可能是註冊性的，我們會得到一份關於此事的頂線新聞稿。

Would you do a top line whether you do or do not decide to file that?

無論您是否決定提交該文件，您都會做一個頂行嗎？

Just trying to get a sense of expectations on that.

只是想了解對此的期望。

Thanks.

謝謝。

Just to clarify, you're talking about the third-line Phase II study in non-small cell lung squamous, right?

澄清一下，你說的是非小細胞肺鱗狀細胞癌的三線 II 期研究，對嗎？

I think that's it, yes.

我想就是這樣，是的。

Okay (multiple speakers).

好的（多個發言者）。

So as I said, but let me reiterate, it's important.

正如我所說，但讓我重申一下，這很重要。

We are in regular contact with the FDA.

我們與 FDA 保持定期聯繫。

We expecting the data in the first part of this year, and depending on the data, and we will obviously be having further discussions with the FDA, but the hope would be for a submission, assuming the data is appropriate.

我們預計今年上半年會得到數據，根據數據的不同，我們顯然會與 FDA 進行進一步的討論，但假設數據合適，我們希望能夠提交。

And I think from a disclosure standpoint, Vamil, we have to wait and see what the data looks like.

我認為，從披露的角度來看，Vamil，我們必須等待，看看數據是什麼樣子。

That's a materiality discussion, certainly, with our General Counsel and legal group, there's the need to preserve the ability to present at AASCO.

當然，這是與我們的總法律顧問和法律團隊進行的實質性討論，有必要保留在 AASCO 上發言的能力。

So there's coordination with AASCO.

因此需要與 AASCO 進行協調。

And then there are competitive dynamics as well.

此外還有競爭動態。

So I think it's premature to commit to any kind of disclosure one way or the other.

因此，我認為現在以某種方式承諾任何形式的披露還為時過早。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

We'll go next to Greg Gilbert with Bank of America.

接下來是美國銀行的格雷格·吉爾伯特。

Yes, thanks.

對了謝謝。

I have two.

我有兩個。

First for Lamberto, clearly immuno-oncology is really exciting for your Company, but I think it's also fair to say your market cap assumes pretty significant success in future years already.

首先，對於 Lamberto 來說，顯然免疫腫瘤學對貴公司來說確實令人興奮，但我認為公平地說，你們的市值在未來幾年已經取得了相當大的成功。

So my question is, do you see, as CEO, an opportunity to use your significant market cap to diversify into other exciting areas if the right opportunities come along?

所以我的問題是，作為首席執行官，如果合適的機會出現，您是否認為有機會利用您的巨大市值進行多元化發展，進入其他令人興奮的領域？

And my follow-up for Charlie is about your mature and other product line.

我對查理的後續行動是關於您的成熟產品線和其他產品線。

Obviously a pretty big chunk of business.

顯然這是一個相當大的業務。

Any key variables we should think about that within that over the next year or so?

在接下來的一年左右的時間裡，我們應該考慮哪些關鍵變量？

Thanks.

謝謝。

Well (inaudible) we have been saying that business development is top priority for our capital allocation.

嗯（聽不清）我們一直說業務發展是我們資本配置的首要任務。

Soon we will receive, if at the closing with the deal, with AstraZeneca, we will see significant amount of money here in the US from AstraZeneca.

很快，如果在與阿斯利康的交易結束時，我們將在美國看到來自阿斯利康的大量資金。

There is an upfront payment plus the milestone related to the approval of Onglyza in the US.

預付款加上與 Onlyza 在美國獲得批准相關的里程碑。

So we will have additional cash available for business development.

因此，我們將有額外的現金可用於業務發展。

As you correctly said, we have shares that are valued, let's say nicely, and therefore we could use those shares also for BD.

正如您所說，我們擁有有價值的股票，可以說得好一些，因此我們也可以將這些股票用於 BD。

We will continue -- we continue, it's not in the future, we continue today at looking at various opportunities, and various opportunities are in both immuno-oncology and outside of immuno-oncology.

我們將繼續——我們繼續，這不是在未來，我們今天繼續尋找各種機會，各種機會都在免疫腫瘤學領域和免疫腫瘤學之外。

So when you think about our priorities, the priorities in business development are in the same areas where we are developing our own programs, or areas that are very close to those areas.

因此，當你考慮我們的優先事項時，業務發展的優先事項與我們正在開發自己的項目的領域相同，或者與這些領域非常接近。

Charlie, about mature brands?

查理，關於成熟品牌？

So Greg on mature brands, it is a catch-all for all of our non-core promoted brands, and we have the normal older sort of off-patent, as well as some OTC brands, particularly in Europe and the market there is France.

因此，格雷格談到成熟品牌時，它涵蓋了我們所有非核心推廣品牌，我們有正常的較舊類型的非專利品牌，以及一些非處方藥品牌，特別是在歐洲和法國市場。

But we also have some growth products, like metformin in China, for example.

但我們也有一些成長型產品，例如中國的二甲雙胍。

We record [Simlet] sales there, which will go away with the diabetes business, and we also record things like our Medarex royalties that we get from that acquisition.

我們記錄了那裡的 [Simlet] 銷售額，這將隨著糖尿病業務而消失，我們還記錄了我們從這次收購中獲得的 Medarex 特許權使用費等內容。

And then also we have a couple of collaborations with Reckitt for some OTC brands in Latin America and then Medicines Company, which was our old Recothrom business.

然後我們還與利潔時在拉丁美洲的一些非處方藥品牌以及 Medicines Company 進行了幾次合作，這是我們以前的 Recothrom 業務。

They have their own life cycle, and some go, as those deals come to a close, that will have a more significant impact on the mature brands.

它們有自己的生命週期，有些隨著交易的結束，將對成熟品牌產生更重大的影響。

But generally, this is a declining business.

但總體而言，這是一項正在衰退的業務。

Thanks, Greg.

謝謝，格雷格。

Can we go to the next question please, Shannon?

香農，我們可以進入下一個問題嗎？

We'll move next to Alex Arfaei with BMO Capital Markets.

接下來我們將請至 BMO 資本市場部的 Alex Arfaei。

Good morning, and congratulations on a great 2013.

早上好，祝賀您度過了美好的 2013 年。

Francis, on Checkmate 26, many experts think that PDL1 expression is dynamic.

Francis，關於Checkmate 26，許多專家認為PDL1表達是動態的。

So the question is, have there been any advances in being able to reliably identify PDL1 positive patients?

那麼問題是，在能夠可靠地識別 PDL1 陽性患者方面是否取得了任何進展？

And the follow-up, if I may, can you please give us more clarity on the timeline for the LAG-3 data?

接下來，如果可以的話，您能給我們更清楚地說明 LAG-3 數據的時間表嗎？

We know you said you (inaudible) mentioned it entered the clinic last quarter, and perhaps more clarity on the timeline for the other immunotherapies going into the clinic.

我們知道您說過（聽不清）提到它在上個季度進入了診所，也許還更清楚地說明了其他免疫療法進入診所的時間表。

Thank you.

謝謝。

Thank you, Alex.

謝謝你，亞歷克斯。

So talking about the first-line lung, I think the goal of making it PDL1 positive is to enrich the population.

所以說到一線肺，我認為使其PDL1呈陽性的目標是豐富人群。

And of course obviously if it changes subsequently, that will be taken into account in terms of what the data is at the end.

當然，顯然如果隨後發生變化，則會根據最後的數據來考慮這一點。

But I think we have the opportunity here to, as I said, and I'll go back, there's a very broad strategy around biomarkers here.

但我認為我們有機會，正如我所說，我會回去，這裡有一個圍繞生物標誌物的非常廣泛的戰略。

There's a lot we don't know about biomarkers.

關於生物標誌物，我們還有很多不了解的地方。

We're learning all the time, and I think we have a greater opportunity over the next year or two as our data matures to have a much better idea of the kinetics of the PDL1 expression and how it might relate to overall survival, not just response rate.

我們一直在學習，我認為隨著我們的數據成熟，我們在未來一兩年有更大的機會更好地了解 PDL1 表達的動力學以及它與整體生存的關係，而不僅僅是反應速度。

And I want to reiterate, again I think it's important that our aim is to be able to provide, if we have the data to support it, a treatment for patients who are PDL1 negative also, whether in lung, melanoma, or any other tumors.

我想再次重申，我認為重要的是，如果我們有數據支持的話，我們的目標是能夠為 PDL1 陰性的患者提供治療，無論是肺癌、黑色素瘤還是任何其他腫瘤。

So it's a very broad program.

所以這是一個非常廣泛的計劃。

We're generating the data, and I think it's rather early yet to speculate too much around what might happen, we want to get the data.

我們正在生成數據，我認為現在對可能發生的情況進行太多推測還為時過早，我們想要獲取數據。

Now as far as our other I/O combinations, many trials ongoing, as I mentioned, like three entered the clinic last quarter.

現在，就我們的其他 I/O 組合而言，正如我提到的，許多試驗正在進行中，比如上個季度有 3 項試驗進入了臨床。

I think that's very early to make any predictions yet, but obviously it's very exciting.

我認為現在做出任何預測還為時過早，但顯然這非常令人興奮。

And perhaps more importantly, we have combinations of nivo with L21 and our [anticare] monoclonal antibody.

也許更重要的是，我們有 nivo 與 L21 和我們的 [anticare] 單克隆抗體的組合。

Also I think you will be seeing data over the next year or two on those, but it's too early to give you an exact timing.

另外，我認為您將在未來一兩年內看到有關這些的數據，但現在給您確切的時間還為時過早。

Thanks.

謝謝。

Shannon, I think we have time for one more question.

香農，我想我們還有時間再問一個問題。

We'll go next to Steve Scala with Cowen & Company.

接下來我們將與 Cowen & Company 一起討論 Steve Scala。

Thank you, and I have two questions.

謝謝你，我有兩個問題。

So Francis, in your prepared comments you referred to Yervoy as the cornerstone of your immuno-oncology franchise, and I'm focusing now on the word cornerstone.

弗朗西斯，在您準備好的評論中，您提到耶沃伊是您的免疫腫瘤學特許經營的基石，我現在重點關注基石這個詞。

I think most immunocologists view PD1 as necessary and fundamental to modulate, and therefore the cornerstone.

我認為大多數免疫學家認為 PD1 是調節的必要條件和基礎，因此是基石。

So it seems to me that Bristol is not absolutely convinced that PD1 is a key component and a cornerstone.

所以在我看來，布里斯托爾並不完全相信 PD1 是一個關鍵組成部分和基石。

Am I correctly characterizing the Bristol view?

我對布里斯托爾觀點的描述正確嗎？

And the second question is on the settlement with Apotex for Sprycel, can you be more specific on when generics can launch?

第二個問題是關於 Sprycel 與 Apotex 的和解，您能否更具體地說明仿製藥何時可以上市？

Thank you.

謝謝。

This is Lamberto.

這是蘭貝托。

My Italian accent should have be recognized when I use the expression cornerstone for Yervoy.

當我使用 Yervoy 的基石這個表達時，我的意大利口音應該被識別出來。

It was probably not appropriate to say the cornerstone.

說基石可能不太合適。

I don't know if I said that.

我不知道我是否這麼說過。

Actually it is a cornerstone.

實際上它是一個基石。

Now to answer your question more directly, PD1 is a cornerstone stone for immunotherapy and we are very committed to it, and we are very convinced that we can deliver important data with PD1 in various tumors, but we are starting.

現在更直接地回答你的問題，PD1是免疫療法的基石，我們非常致力於它，我們非常確信我們可以用PD1在各種腫瘤中提供重要數據，但我們正在開始。

You want to add anything?

你想添加什麼嗎？

I would just add that I fully agree with Lamberto's characterization of the promise of PD1, and so you shouldn't misunderstand how excited we are.

我想補充一點，我完全同意 Lamberto 對 PD1 承諾的描述，所以你不應該誤解我們有多興奮。

But on the other hand, Yervoy is approved, and I think I've been in this business long enough to know that a bird in the hand is always worth a lot.

但另一方面，Yervoy 得到了認可，我想我在這個行業已經呆了足夠長的時間了，知道一鳥在手總是值很多錢。

So it's a very good bird to have in the hand and it gives us a lot of opportunity to build on that, I think, in terms of a broader I/O benefit for patients.

因此，這是一隻非常好的鳥，我認為，就為患者帶來更廣泛的 I/O 益處而言，它為我們提供了很多機會。

And Steve, on the Sprycel, I think we have at least 10 more years of market exclusivity related to that case for Sprycel in the US.

史蒂夫，關於 Sprycel，我認為與 Sprycel 在美國的情況相關，我們至少還有 10 年的市場獨占權。

So with that, I'm going to turn it back over to Lamberto.

因此，我將把它轉回蘭貝托。

Thanks everybody for all your questions, and I'm really glad that Francis was able to join us this morning.

感謝大家提出的所有問題，我很高興弗朗西斯今天早上能夠加入我們。

Yes, Francis will need now a couple of hours of rest.

是的，弗朗西斯現在需要幾個小時的休息。

And let me close this call by saying that again, 2013 was an important year for us because we are evolving into this new leading specialty care biopharma company.

在結束這次電話會議時，我要再次強調，2013 年對我們來說是重要的一年，因為我們正在發展成為一家新的領先的專業護理生物製藥公司。

I think that the solid performance of last year and the developments and changes that we have delivered put us in a strong position.

我認為去年的穩健表現以及我們所實現的發展和變化使我們處於有利地位。

We have talked a lot about immuno-oncology this morning.

今天早上我們討論了很多關於免疫腫瘤學的問題。

We have very excited about what we have in immuno-oncology, and as I said before, we intend to maintain our leadership position in that area.

我們對免疫腫瘤學領域的成果感到非常興奮，正如我之前所說，我們打算保持我們在該領域的領導地位。

But we also want to continue to evolve the other important assets that we have in cardiovascular and Hepatitis C and virology in general, and the other areas where we are operating.

但我們還希望繼續發展我們在心血管、丙型肝炎和病毒學以及我們開展業務的其他領域所擁有的其他重要資產。

So thank you for being with us this morning, and have a good day.

感謝您今天早上和我們在一起，祝您有美好的一天。

Thank you, Shannon.

謝謝你，香農。

That does conclude today's conference.

今天的會議到此結束。

Thank you for your participation.

感謝您的參與。