施貴寶 (BMY) 2013 Q3 法說會逐字稿

Good day, and welcome to today's third-quarter earnings 2013 earnings release conference call. This call is being recorded.

大家好，歡迎參加今天的 2013 年第三季度財報電話會議。此通話正在錄音。

At this time, I would like to turn the call over to Mr. John Elicker, Senior Vice President, Investor Relations and Public Affairs. Please go ahead, Mr. Elicker.

現在，我想將電話轉給投資者關係和公共事務高級副總裁 John Elicker 先生。請繼續，埃利克先生。

Thanks, Leslie, and good morning, everybody. Thanks for joining us to review our Q3 results.

謝謝，萊斯利，大家早上好。感謝您加入我們查看第三季度的結果。

With me this morning with prepared remarks are Lamberto Andreotti, our Chief Executive Officer; Charlie Bancroft, our Chief Financial Officer; and this morning also with prepared remarks will be Francis Cuss, our Chief Scientific Officer. And then, joining for Q&A are our two commercial leads, Executive Vice President Beatrice Cazala, and the President of US Operations, Giovanni Caforio.

今天早上與我一起發表事先準備好的講話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；今天上午，我們的首席科學官弗朗西斯·庫斯 (Francis Cuss) 也將發表事先準備好的講話。然後，加入問答環節的是我們的兩位商務主管，執行副總裁 Beatrice Cazala 和美國運營總裁 Giovanni Caforio。

Before I turn it over to Lamberto, I just want to cover the Safe Harbor language. As you know, during the call we'll make statements about the Company's future plans and prospects that constitute forward-looking statements. 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.

在將其交給 Lamberto 之前，我只想介紹一下安全港語言。如您所知，在電話會議期間，我們將就公司的未來計劃和前景發表前瞻性聲明。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. We specifically disclaim any obligation to update forward-looking statements, even if our estimates change.

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。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. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at our website, bms.com.

我們還將討論調整後的非公認會計原則財務指標，以排除某些特定項目。這些非 GAAP 財務指標與最具可比性的 GAAP 指標的調節表可在我們的網站 bms.com 上找到。

Lamberto?

蘭貝托？

Thank you, John. Good morning, everyone. This is an important time for Bristol-Myers Squibb. The third quarter marked our return to growth with respect to both sales and earnings, as we made our way through the PLAVIX loss of exclusivity. And that, combined with our continued pipeline progress, positions us well for the future.

謝謝你，約翰。大家，早安。對於百時美施貴寶來說，這是一個重要的時刻。第三季度標誌著我們的銷售和收入恢復增長，因為我們克服了 PLAVIX 獨家經營權的損失。再加上我們不斷取得的管道進展，使我們為未來做好了準備。

Let me elaborate on these points. With respect to sales, not only was our growth strong, up 9%, but also it was diversified, cutting across our portfolio. We drove double-digit growth in Yervoy, Orencia, Sprycel, and Onglyza, and the contribution to the top-line results from Eliquis and Bydureon started to become meaningful. This is important; it demonstrates the breadth and quality of our diversified portfolio.

讓我詳細闡述一下這些觀點。就銷售而言，我們的增長不僅強勁，增長了 9%，而且還實現了多元化，涵蓋了我們的產品組合。我們推動了 Yervoy、Orencia、Sprycel 和 Onglyza 的兩位數增長，Eliquis 和 Bydureon 對營收的貢獻開始變得有意義。這個很重要;它展示了我們多元化投資組合的廣度和質量。

Yervoy remains the cornerstone of our broad immuno-oncology platform. I'm excited -- in fact, I'm very excited by the data presented at the European cancer congress in September, as it confirmed long-term survival with Yervoy immunostatic melanoma, and reinforced the overall value of this product. Last quarter, Yervoy continued to deliver growth, most notably in Europe and our international markets. Yervoy results in the US were also positive, notwithstanding the impact of a significant number of new clinical trials targeting melanoma patients with other agents. In Europe, the CHMP recently recommended that Yervoy be approved as first-line therapy in advanced melanoma.

Yervoy 仍然是我們廣泛的免疫腫瘤學平台的基石。我很興奮——事實上，我對 ​​9 月份歐洲癌症大會上公佈的數據感到非常興奮，因為它證實了 Yervoy 免疫抑制性黑色素瘤的長期生存，並增強了該產品的整體價值。上季度，Yervoy 繼續實現增長，尤其是在歐洲和國際市場。儘管大量針對黑色素瘤患者的新臨床試驗與其他藥物產生了影響，但 Yervoy 在美國的結果也是積極的。在歐洲，CHMP 最近建議批准 Yervoy 作為晚期黑色素瘤的一線療法。

With respect to Eliquis, I'm encouraged. We are still very far from the sales level this product can achieve, but we are seeing definite signs of progress, especially with cardiologists, a target audience for us. We continue to execute against our strategy to clearly define the differentiated and unique profile of Eliquis. In all countries, we have increased our peer-to-peer medical education activities, and in the US you may have seen that we have -- we began our DTC advertising campaign in September for Eliquis in atrial fibrillation. We are also working to expand our label as we have filed an sNDA for VTE prevention in the US, which is already an approved indication in Europe, and we plan to file our application in VTE treatment this year.

對於 Eliquis，我很受鼓舞。我們距離該產品可以達到的銷售水平還很遠，但我們看到了明顯的進步跡象，特別是對於我們的目標受眾心髒病專家。我們繼續執行我們的戰略，以明確定義 Eliquis 的差異化和獨特形象。在所有國家，我們都增加了點對點醫學教育活動，在美國，您可能已經看到，我們於 9 月份開始針對 Eliquis 治療房顫的 DTC 廣告活動。我們還在努力擴大我們的標籤，因為我們已經在美國提交了預防 VTE 的 sNDA，這在歐洲已經是批准的適應症，我們計劃今年提交 VTE 治療的申請。

With respect to our diabetes portfolio, we continue to find our way through this very competitive space. In the third quarter, Onglyza sales grew 19% year over year, and within our exenatide franchise, Bydureon sales showed encouraging gains. And, with dapagliflozin, we are looking forward to the FDA advisory committee meeting in December and the PDUFA date in January.

就我們的糖尿病產品組合而言，我們繼續在這個競爭非常激烈的領域尋找出路。第三季度，Onglyza 銷售額同比增長 19%，在我們的艾塞那肽特許經營範圍內，Bydureon 銷售額顯示出令人鼓舞的增長。而且，對於達格列淨，我們期待 12 月份的 FDA 諮詢委員會會議和 1 月份的 PDUFA 日期。

Let me make a couple of comments about our pipeline. With respect to hepatitis C, we believe that we have an interesting opportunity, and we are looking forward to the AASLD conference next month when we will present new data on the phase III trial of our all-oral dual regimen, and we are still on track for its important submission in Japan this year.

讓我對我們的管道發表一些評論。關於丙型肝炎，我們相信我們有一個有趣的機會，我們期待下個月的 AASLD 會議，屆時我們將展示我們全口服雙方案 III 期試驗的新數據，我們仍在繼續跟踪今年在日本的重要提交。

And with respect to immuno-oncology, 2013 has been a year of exciting data for our immuno-oncology platform. Data we have presented so far this year spoke to the very real possibility of paradigm-changing treatments for a range of cancers. And next week, we will present additional immuno-oncology data at the world conference [on lung].

就免疫腫瘤學而言，2013 年對於我們的免疫腫瘤學平台來說是令人興奮的一年。今年迄今為止我們提供的數據表明了改變一系列癌症治療模式的真實可能性。下週，我們將在[肺部]世界會議上提供更多免疫腫瘤學數據。

Now, because there is much happening related to our work in immuno-oncology, I've asked Francis to spend a few minutes this morning to walk through our thinking with respect to this increasingly important area for us. Francis?

現在，由於我們在免疫腫瘤學方面的工作發生了很多事情，我請弗朗西斯今天早上花幾分鐘時間來回顧一下我們對這個對我們日益重要的領域的思考。弗朗西斯？

Thank you, Lamberto, and good morning, everyone. As you well know, we've been focused on expanding our efforts in immuno-oncology as an area where we see a potential paradigm shift in the treatment of patients with certain cancers. We believe that immuno-oncology has the potential to be transformational in the treatment of patients suffering from various types of cancer. The durability of response and long-term survival in some patients are quite unlike anything we've seen in the past, and as demonstrated by the long-term survival data for Yervoy recently presented at the European Cancer Congress.

謝謝你，蘭貝托，大家早上好。如您所知，我們一直致力於擴大免疫腫瘤學領域的努力，我們認為在該領域，某些癌症患者的治療可能會發生範式轉變。我們相信免疫腫瘤學有可能在治療各種癌症患者方面帶來變革。一些患者的反應持久性和長期生存率與我們過去所見過的完全不同，正如最近在歐洲癌症大會上提交的 Yervoy 長期生存數據所證明的那樣。

Additionally, early data suggests that the immuno-therapeutic approach has the potential to provide a benefit not only in tumors traditionally considered immunogenic, but also in other tumor types that have not typically been thought to be immune-mediated. As the field continues to evolve and expand, we believe that there may be roles for monotherapy, combination therapy, and biomarker-directed therapy, and we're, therefore, building our development programs to prepare for all possibilities.

此外，早期數據表明，免疫治療方法不僅有可能為傳統上被認為具有免疫原性的腫瘤帶來益處，而且還可以為通常不被認為是免疫介導的其他腫瘤類型帶來益處。隨著該領域的不斷發展和擴展，我們相信單一療法、聯合療法和生物標誌物導向療法可能發揮作用，因此，我們正在製定我們的開發計劃，為所有可能性做好準備。

Certainly, the approaches are likely to vary by tumor type, as well as by line of therapy. Through our experience with Yervoy and broad programs with nivolumab, we have a unique understanding in the field, which gives us confidence that we are well positioned to find the optimal way to utilize these innovative therapies.

當然，這些方法可能會因腫瘤類型以及治療方案而異。通過我們在 Yervoy 的經驗和廣泛的納武單抗項目，我們對該領域有獨特的理解，這讓我們相信我們有能力找到利用這些創新療法的最佳方法。

As you know, we've made a very large commitment to immuno-oncology. Currently for nivolumab alone, we have over 25 ongoing clinical trials across more than eight tumor types. We continue to explore Yervoy monotherapy in additional tumor types, such as prostate and lung, as well as in combination with nivolumab. In addition, we have a broad portfolio of exploratory immuno-therapeutic agents with varying immune mechanisms of action that allows us to explore multiple combinations.

如您所知，我們對免疫腫瘤學做出了非常大的承諾。目前，僅就納武單抗而言，我們就有超過 25 項正在進行的臨床試驗，涉及超過 8 種腫瘤類型。我們繼續探索 Yervoy 單藥治療其他腫瘤類型（例如前列腺癌和肺癌）以及與納武單抗的聯合治療。此外，我們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。

Today, I'd like to provide a brief update on the status of our major programs. Let me start with lung cancer. As a follow up to the data we presented at ASCO in June, we will be presenting updated two-year survival data from the lung cohort of prior-treated patients in the nivolumab monotherapy study known as 003 at the World Conference on lung cancer at the end of October.

今天，我想簡要介紹一下我們主要項目的最新情況。讓我從肺癌開始。作為我們 6 月份在 ASCO 上公佈的數據的後續行動，我們將在世界肺癌大會上公佈 003 號納武單抗單藥治療研究中既往治療過的患者肺部隊列的最新兩年生存數據。十月底。

Next up will be data from the phase I combination study of nivolumab with Yervoy in non-small-cell lung cancer, which we expect to have in-house by the end of the year. [Data from] this study will provide important information on the feasibility of combinations in this tumor type, and potentially inform our plans for phase III trials starting in the first half of 2014.

接下來將是納武單抗與 Yervoy 治療非小細胞肺癌的 I 期聯合研究的數據，我們預計將在今年年底前獲得內部數據。[來自]這項研究的數據將提供有關這種腫瘤類型聯合用藥可行性的重要信息，並可能為我們於 2014 年上半年開始的 III 期試驗計劃提供信息。

Following that, we expect to have data in the first part of 2014 from our phase II study in third-line, squamous non-small-cell lung cancer. 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.

此後，我們預計將在 2014 年上半年獲得三線鱗狀非小細胞肺癌 II 期研究的數據。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。

Finally, we have two ongoing phase III trials in second-line, non-small-cell lung cancer, one in squamous and one in non-squamous, with both studies collecting information on PD-L1 tumor expression. We expect to have data from these studies later in 2014.

最後，我們正在進行兩項針對二線非小細胞肺癌的 III 期試驗，一項針對鱗狀細胞肺癌，一項針對非鱗狀細胞肺癌，這兩項研究都收集有關 PD-L1 腫瘤表達的信息。我們預計將在 2014 年晚些時候獲得這些研究的數據。

In melanoma, we have a broad program ongoing with trials covering all lines of therapy, which includes monotherapy as well as combination of nivolumab and Yervoy. In previously untreated patients, both monotherapy and combination phase III trials are underway, and a nivolumab monotherapy phase III trial is ongoing in advanced patients who have progressed post-Yervoy.

在黑色素瘤方面，我們正在進行一項廣泛的計劃，試驗涵蓋所有療法，包括單一療法以及納武單抗和 Yervoy 的組合療法。對於既往未經治療的患者，單藥治療和聯合治療 III 期試驗正在進行中，針對 Yervoy 後病情進展的晚期患者正在進行納武單抗單藥治療 III 期試驗。

In renal cell cancer, our most advanced trial is focused on metastatic disease, comparing nivolumab with Everolimus. Earlier trials are exploring the combination of nivolumab and Yervoy in first-line renal cell cancer, and we expect the data in-house by the end of this year, and also expect early data on the potential role of biomarkers in this tumor type. In all these three tumor types, we remain committed to establishing the benefit/risk profile of nivolumab as quickly as possible, and are closely collaborating with health authorities.

在腎細胞癌中，我們最先進的試驗主要針對轉移性疾病，將納武單抗與依維莫司進行比較。早期試驗正在探索納武單抗和 Yervoy 聯合治療一線腎細胞癌，我們預計在今年年底之前獲得內部數據，並且還期望獲得有關生物標誌物在這種腫瘤類型中潛在作用的早期數據。在所有這三種腫瘤類型中，我們仍然致力於盡快確定納武單抗的獲益/風險概況，並與衛生當局密切合作。

Now, regarding public data presentations, after the lung data at the World Conference on lung cancer, we expect the next set of presentations to be at ASCO in 2014, which may include data on the phase I combination study in non-small-cell lung cancer and potentially data from the third-line squamous non-small-cell lung cancer, which is ongoing. In addition to the programs for nivolumab that I highlighted earlier, we're also exploring its use in additional solid tumor types, including pancreatic, gastric, small-cell lung cancer, and triple-negative breast cancer, as well as hematological malignancies.

現在，關於公開數據演示，繼世界肺癌大會上的肺部數據之後，我們預計下一組演示將於 2014 年在 ASCO 上進行，其中可能包括非小細胞肺癌 I 期聯合研究的數據癌症以及來自三線鱗狀非小細胞肺癌的潛在數據，該研究正在進行中。除了我之前強調的納武單抗項目外，我們還在探索其在其他實體瘤類型中的應用，包括胰腺癌、胃癌、小細胞肺癌和三陰性乳腺癌以及血液惡性腫瘤。

In closing, I think you can see that we have a significant commitment to advancing the field of immuno-oncology through a broad program that is science-driven, diversified, and well resourced. We believe that this commitment, together with our expertise and experience, puts us in an excellent position in this tremendously exciting area.

最後，我認為您可以看到，我們致力於通過科學驅動、多元化且資源充足的廣泛計劃來推進免疫腫瘤學領域的發展。我們相信，這一承諾加上我們的專業知識和經驗，使我們在這個令人興奮的領域處於有利地位。

Now I'd like to turn it back to you, Lamberto.

現在我想把它轉回給你，蘭貝托。

Thanks, Francis. Clearly, we see immuno-oncology as an important and exciting opportunity for us. One in which we will continue investing heavily, dedicating even more resources -- time, people and money -- not only in R&D but also commercially as we prepare for potential launches.

謝謝，弗朗西斯。顯然，我們認為免疫腫瘤學對我們來說是一個重要且令人興奮的機會。我們將繼續大力投資，投入更多的資源——時間、人力和金錢——不僅在研發方面，而且在我們為潛在的發布做準備時也在商業方面。

We are also committing the right commercial resources to our key growth drivers, most notably Eliquis, diabetes, and hepatitis C. These products and these therapeutic areas are our future, and my management team and I are determined to set the stage for long-term, sustainable growth, while at the same time, driving short-term performance.

我們還致力於為我們的關鍵增長動力投入正確的商業資源，尤其是 Eliquis、糖尿病和丙型肝炎。這些產品和這些治療領域是我們的未來，我和我的管理團隊決心為長期目標奠定基礎，可持續增長，同時推動短期業績。

Now, with that, I will turn the floor over to Charlie to talk through some of our key numbers. Charlie?

現在，我將把發言權交給查理來討論我們的一些關鍵數字。查理？

Thank you, Lamberto. Net sales were $4.1 billion in the quarter. We also had solid sales performance across our entire portfolio, especially for Yervoy, Sprycel, Orencia, and Bydureon.

謝謝你，蘭貝托。該季度淨銷售額為 41 億美元。我們的整個產品組合也取得了穩健的銷售業績，尤其是 Yervoy、Sprycel、Orencia 和 Bydureon。

Let me provide a few highlights. Yervoy sales increased 33% year over year to $238 million. Yervoy continued to show strong performance in Europe. We recently received a positive opinion from the CHMP for first-line use of Yervoy, and hope to have marketing authorization later this year. This is an important addition to our label in Europe, and will allow a broader set of patients to potentially benefit earlier in their treatment.

讓我提供一些亮點。Yervoy 銷售額同比增長 33%，達到 2.38 億美元。Yervoy 在歐洲繼續展現強勁表現。我們最近收到了 CHMP 對 Yervoy 一線使用的積極意見，並希望在今年晚些時候獲得營銷授權。這是我們在歐洲標籤的一個重要補充，將使更多的患者能夠在治療的早期受益。

In the US, Yervoy sales softened somewhat from the second quarter. As Lamberto mentioned, we have seen an impact from a significant increase in new clinical trials targeting melanoma. Patient enrollment in metastatic melanoma trials has more than doubled since the beginning of the year, with some of that increase coming from our own clinical trials with nivolumab. While these clinical trials have affected the commercial opportunity at several large academic institutions, we continue to focus on growing Yervoy in the community setting, which represents approximately 60% of our US sales.

在美國，Yervoy 的銷售額較第二季度有所放緩。正如蘭貝托提到的，我們已經看到針對黑色素瘤的新臨床試驗顯著增加所產生的影響。自今年年初以來，轉移性黑色素瘤試驗的患者入組人數增加了一倍多，其中一些增長來自我們自己的納武單抗臨床試驗。雖然這些臨床試驗影響了幾個大型學術機構的商業機會，但我們繼續專注於在社區環境中種植 Yervoy，這約占我們美國銷售額的 60%。

Recent weekly sales trends are encouraging. We believe having the first-line indication in Europe, along with the survival data presented at the European Cancer Congress, will enable us to continue to deliver strong growth.

最近的每週銷售趨勢令人鼓舞。我們相信，在歐洲擁有一線適應症，以及歐洲癌症大會上公佈的生存數據，將使我們能夠繼續實現強勁增長。

Sales of Eliquis were $41 million during the quarter. As Lamberto mentioned, we have several initiatives focused on helping prescribers, patients, and payers understand Eliquis's differentiated profile. Recent prescription trends are improving, as we have seen consistent weekly growth during Q3. As an important leading indicator, our overall new-to-brand share has improved, and is now nearly 20% with cardiologists.

Eliquis 該季度的銷售額為 4100 萬美元。正如 Lamberto 提到的，我們有幾項舉措致力於幫助處方者、患者和付款人了解 Eliquis 的差異化概況。最近的處方趨勢正在改善，因為我們看到第三季度每週持續增長。作為一項重要的領先指標，我們的整體新品牌份額有所提高，目前心髒病專家的份額已接近 20%。

Our diabetes portfolio had sales of $411 million in the quarter. After a period of transition in our diabetes organization, we are beginning to see more positive trends in this business. Sales for the exenatide franchise were $193 million, up nearly 14% from Q2, mostly due to renewed new-to-brand growth for Bydureon and GLP-1 market expansion. Byetta sales were essentially flat versus Q2.

我們的糖尿病產品組合本季度銷售額為 4.11 億美元。在我們的糖尿病組織經歷一段過渡期之後，我們開始看到該業務出現更多積極的趨勢。艾塞那肽特許經營權的銷售額為 1.93 億美元，較第二季度增長近 14%，這主要是由於 Bydureon 和 GLP-1 市場擴張的新品牌增長。Byetta 銷售額與第二季度基本持平。

Sales for the Onglyza franchise grew 19% year over year to $211 million. We have stabilized our market share in the US, where total prescription growth is slowing. We believe the data from the [SAVOR] cardiovascular outcomes trial provides important clarity regarding the safety profile of Onglyza. We continue to work through the pricing and reimbursement process for Forxiga in Europe, and look forward to a potential launch in the US next year.

Onlyza 特許經營權的銷售額同比增長 19%，達到 2.11 億美元。我們已經穩定了在美國的市場份額，美國的處方藥總量增長正在放緩。我們相信 [SAVOR] 心血管結果試驗的數據提供了有關 Onlyza 安全性的重要清晰度。我們將繼續研究 Forxiga 在歐洲的定價和報銷流程，並期待明年在美國推出。

Orencia sales increased 22% to $375 million. Sub-Q sales have nearly doubled since Q3 2012, and now represent nearly one-third of all Orencia sales.

Orencia 銷售額增長 22%，達到 3.75 億美元。自 2012 年第三季度以來，Q 級以下的銷售額幾乎翻了一番，目前佔 Orencia 總銷售額的近三分之一。

Sprycel sales rose 20% to $316 million. First-line use of Sprycel also is growing as we reinforce Sprycel's broad indication to treat patients in all phases of CML.

Sprycel 銷售額增長 20%，達到 3.16 億美元。隨著我們加強 Sprycel 治療 CML 各個階段患者的廣泛適應症，Sprycel 的一線使用也在增長。

Now, let me highlight two line items from the rest of our non-GAAP P&L. Advertising and promotion spending increased 16% to $194 million. This is driven by our increased investment behind our key commercial opportunities such as Eliquis and our diabetes portfolio. We expect to continue these investments, as well as ensure we are prepared for the expected hepatitis C launch in Japan and potential launches for nivolumab. As I mentioned during our second-quarter call, the decrease in other income and expense is largely due to the change in the structure of our relationship with Sanofi, whereby we now record royalty income in net sales. As you have seen, we are confirming our full-year 2013 GAAP and non-GAAP EPS ranges.

現在，讓我重點介紹我們其餘非 GAAP 損益表中的兩個項目。廣告和促銷支出增長 16%，達到 1.94 億美元。這是由於我們對 Eliquis 和糖尿病產品組合等關鍵商業機會的投資增加所推動的。我們預計將繼續這些投資，並確保我們為預期在日本推出的丙型肝炎和納武單抗的潛在推出做好準備。正如我在第二季度電話會議中提到的，其他收入和支出的減少主要是由於我們與賽諾菲關係結構的變化，我們現在將特許權使用費收入記錄在淨銷售額中。正如您所看到的，我們正在確認 2013 年全年 GAAP 和非 GAAP 每股收益範圍。

Before we turn to your questions, I want to make a few comments about capital allocation. Business development continues to be our top priority, and we remain committed to the dividend. Regarding share repurchases, you will recall that overall repurchases slowed significantly in Q2, and this trend continued in the third quarter. Moving forward, we do not anticipate future share repurchases at this time.

在回答你的問題之前，我想就資本配置發表一些評論。業務發展仍然是我們的首要任務，我們仍然致力於股息。關於股票回購，大家可能還記得，第二季度整體回購速度明顯放緩，第三季度這一趨勢仍在繼續。展望未來，我們目前預計未來不會回購股票。

We are now happy to answer your questions.

我們現在很高興回答您的問題。

Thanks, Charlie. Leslie, we can go to Q&A now. And I would just remind everybody that, in addition to Lamberto, Charlie and Francis, we have both Giovanni and Beatrice here to handle any questions you might have. Leslie?

謝謝，查理。萊斯利，我們現在可以進行問答了。我想提醒大家，除了蘭貝托、查理和弗朗西斯之外，我們還有喬瓦尼和比阿特麗斯來處理你們可能有的任何問題。萊斯利？

(Operator Instructions)

（操作員說明）

We'll take our first question from Seamus Fernandez with Leerink.

我們將回答 Seamus Fernandez 和 Leerink 提出的第一個問題。

First off, on the trajectory of the Eliquis franchise, can you just give us your thoughts and expectations for -- should we anticipate stronger performances internationally than in the US? And, why has it been so difficult? Can you just give us a little bit of the lay of the land of the competitive landscape and perhaps what competitors may have convinced physicians of early on, and how you're going to hopefully change their mindset?

首先，關於 Eliquis 特許經營的發展軌跡，您能否告訴我們您的想法和期望——我們是否應該預期在國際上的表現會比在美國更好？而且，為什麼這麼難？您能否向我們介紹一下競爭格局的概況，以及競爭對手可能在早期就說服了醫生的內容，以及您將如何希望改變他們的心態？

And then, separately, Francis, you mentioned -- you made an interesting comment with regard to how the phase I trial in lung may inform a potential move into phase 3 in 2014 for nivolumab plus Yervoy in lung cancer. Can you help us better understand the thresholds as we think about it? There's been a lot of circulating concern around potential toxicity there, but obviously, the prospect of improved efficacy is something important. So, just wondering how Bristol would be thinking about the threshold? Or, at least how we should think about your move into phase 3 with this potential combination? Should that be the decision that you make in 2014. Thanks.

然後，弗朗西斯，您提到，您對肺部 I 期試驗如何可能為 2014 年納武單抗加 Yervoy 治療肺癌可能進入 3 期提供信息發表了有趣的評論。當我們思考這個問題時，您能幫助我們更好地理解閾值嗎？人們對潛在毒性存在很多擔憂，但顯然，提高療效的前景很重要。那麼，只是想知道布里斯托爾會如何考慮門檻？或者，至少我們應該如何考慮通過這種潛在的組合進入第三階段？這應該是你在 2014 年做出的決定嗎？謝謝。

Okay, Seamus. This is Lamberto. I will start, and then I will ask Giovanni and Beatrice to add comments on Eliquis. First of all, we expect growth for Eliquis in both the US and international markets, and in some of the international markets we have just launched. In the US, we launched earlier. In other countries, we launched earlier, so we are at different stage of launch. But, the launch continues in both the US and internationally.

好吧，西莫。這是蘭貝托。我將開始，然後我將請 Giovanni 和 Beatrice 添加對 Eliquis 的評論。首先，我們預計 Eliquis 在美國和國際市場以及我們剛剛推出的一些國際市場都會增長。在美國，我們更早推出。在其他國家，我們推出得更早，所以我們處於不同的推出階段。但是，該產品在美國和國際上的推出仍在繼續。

We were third to the market, and we found two other agents that were entrenched in the market, especially one of them. The good news is that I'm sure that our clinical data is very significant, very differentiated. Both the Aristotle and the other [rose] data is good. Nobody can make the same claim, and so we are dealing with especially one agent that is basing their strength on having launched earlier. And, speaking about convenience, which we don't think it's really a great claim, but so we will continue to work. And, we are continuing to work, and Giovanni, why don't you start with the US, saying what we are doing.

我們是第三個進入市場的，我們發現了另外兩個在市場上根深蒂固的代理商，尤其是其中之一。好消息是，我確信我們的臨床數據非常重要、非常獨特。亞里士多德和其他[玫瑰]的數據都很好。沒有人可以做出同樣的主張，因此我們正在與一位代理商打交道，該代理商的優勢在於較早推出。而且，談到便利性，我們認為這並不是一個很好的主張，但我們將繼續努力。而且，我們正在繼續工作，喬瓦尼，你為什麼不從美國開始，說明我們正在做什麼。

Good morning. Just to follow up on what Lamberto said, so if you think about our focus in 2013 in the US market consistent with what we discussed at the last call, we are focused in a number of areas. At the beginning, we had a very heavy focus on access, and we made rapid progress there. Then, we, in parallel, shifted our focus on our presence in the hospital and the process of entering the hospitals from a [formularistic] perspective, and stocking is a process that requires time. We discussed that at the last call. We've made significant progress in the third quarter in that area. At this point, we are stocked and present in over 80% of our focus hospitals. Our use in the hospitals has been increasing, and we're quite satisfied at this point that we are at the same level of hospital presence where Xarelto, for example, was at the same time during their launch.

早上好。只是為了跟進 Lamberto 所說的內容，所以如果您認為我們 2013 年在美國市場的重點與我們在上次電話會議中討論的內容一致，我們將重點關注多個領域。一開始，我們非常注重訪問，並且在這方面取得了快速進展。然後我們同時從[公式化]的角度把注意力轉向我們在醫院的存在和進入醫院的過程，備貨是一個需要時間的過程。我們在上次通話中討論了這一點。第三季度我們在該領域取得了重大進展。目前，我們已在超過 80% 的重點醫院備有庫存。我們在醫院的使用量一直在增加，目前我們非常滿意，因為我們的醫院存在水平與拜瑞妥（Xarelto）在其推出期間的同一水平相同。

As we've discussed earlier, we have a very heavy focus on medical education and peer-to-peer programs because we really have the broadest and the deepest data set in atrial fibrillation of all agents and understanding that profile requires time in the right setting for physicians, so we have actually increased very significantly our investment. In that area, we are executing a very large number of programs, and we continue to see then when physicians have the time to understand the data they really understand the differentiated profile of Eliquis. We also started DTC and the TV ads, and that will have an impact over time. As was mentioned before, although our update clearly has been slower than we had expected, we actually are making good progress in the third quarter. Our growth over the last four weeks in TRXs is 23%. Our growth in NBRXs is close to 20%. When you look at the cardiology setting, in a quarter during which the new-to-brand prescriptions of both Pradaxa and Xarelto were flat, we experienced very, very good growth. Our NBRX share in cardiology now is close to 19%, which compares to 12% for Pradaxa, so we are continuing to make progress in the areas of focus going forward that the same as I just described.

正如我們之前討論的，我們非常關注醫學教育和同行項目，因為我們確實擁有所有藥物中最廣泛和最深入的房顫數據集，並且了解該概況需要在正確的環境中花費時間對於醫生來說，所以我們實際上顯著增加了我們的投資。在該領域，我們正在執行大量的項目，並且當醫生有時間了解數據時，我們將繼續看到他們真正了解 Eliquis 的差異化特徵。我們還啟動了 DTC 和電視廣告，隨著時間的推移，這將會產生影響。正如之前提到的，雖然我們的更新明顯比我們預期的要慢，但我們實際上在第三季度取得了良好的進展。過去四個星期我們的 TRX 增長了 23%。我們的 NBRX 增長接近 20%。當你觀察心髒病學環境時，在 Pradaxa 和 Xarelto 的新品牌處方量持平的一個季度中，我們經歷了非常非常好的增長。我們的 NBRX 在心髒病學領域的份額現在接近 19%，而 Pradaxa 的份額為 12%，因此我們將繼續在未來的重點領域取得進展，正如我剛才所描述的那樣。

Regarding International, first, let me talk briefly about Europe. We have now launched Eliquis in about 13 countries, and we saw significant growth, more than 100% quarter-over-quarter. We are applying to launch in another four countries across Europe, including Italy. So, the staggered launch also accounts for possibly the slower uptake that you can see. We are feeling positive now about access. We are focusing our launch effort mainly on the [cadulities], and we are allocating resources strongly at the hospital but also differentiating versus the level of [not] penetration in various markets. What makes Europe also is very different penetration of the [Nulojix], which give us a lot of opportunities, because you go from countries where Nulojix is only at 2% penetration, and others where it is already 25%. We're clearly differentiating our investment there and will be very competitive in also segments of the markets and older various markets.

關於國際，首先我簡單說一下歐洲。我們現已在大約 13 個國家推出 Eliquis，並且我們看到了顯著的增長，季度環比超過 100%。我們正在申請在歐洲另外四個國家推出，其中包括意大利。因此，交錯發布也可能是您所看到的吸收速度較慢的原因。我們現在對訪問感到積極。我們的啟動工作主要集中在[人員]上，我們在醫院大力分配資源，但也根據不同市場的[非]滲透水平進行區分。歐洲的另一個特點是 [Nulojix] 的滲透率非常不同，這給了我們很多機會，因為你來自 Nulojix 僅滲透率 2% 的國家，而其他國家的滲透率已經達到 25%。我們在那裡的投資顯然具有差異化，並且在細分市場和較舊的各種市場中也將具有很強的競爭力。

We're continuing doing strong medical education. Let's not forget that atrial fibrillation starts with the hospital. Most of the patients go through the hospital in Europe. They move to the cardiologists and the general practitioners. We are trying to accelerate the hospital discharge and the prescription at the hospital level between cardiologists and general practitioners. A lot of education needs to take place, and this is happening now. We are very focused on our resources there, and as we see now more recent market, that's how we see that differentiated profile starts being perceived by the cardiologists, which are [systemically] very important for the long-term [use] of the products.

我們正在繼續開展強有力的醫學教育。我們不要忘記，房顫是從醫院開始的。大多數患者都經過歐洲的醫院。他們轉向心髒病專家和全科醫生。我們正在努力加快心髒病專家和全科醫生之間的出院和醫院層面的處方。需要進行大量的教育，而這一切現在正在發生。我們非常專注於我們在那裡的資源，正如我們現在看到的最近的市場一樣，這就是我們看到心髒病專家開始認識到差異化特徵的方式，這對於產品的長期[使用]來說[系統地]非常重要。

Thank you, Seamus. This is Francis Cuss. As the -- as we were very encouraged with the melanoma data with the combination, and we were pleasantly surprised that the tolerability where we saw there. But, as you appreciate, lung cancer is a different indication, and we will be looking clearly at the therapeutic index. We don't have the data yet, and I can't speculate about what we will see. But, just to remind you that, of course, what we believe is one of the most valuable aspects of immunotherapy is the durable response, and that data set will be evolving over the next 6 to 12 months. And, of course, our hope will be with the combination that we will see an enhanced durable response.

謝謝你，西莫。這是弗朗西斯·庫斯。正如我們對組合的黑色素瘤數據感到非常鼓舞一樣，我們對我們在那裡看到的耐受性感到驚喜。但是，正如您所理解的，肺癌是一個不同的適應症，我們將清楚地關注治療指數。我們還沒有數據，我無法推測我們會看到什麼。但是，只是提醒您，當然，我們認為免疫療法最有價值的方面之一是持久的反應，並且該數據集將在未來 6 至 12 個月內不斷發展。當然，我們希望通過這種結合，我們能夠看到更持久的反應。

Thanks for the question, Seamus. Leslie -- next, please.

謝謝你的提問，西莫。萊斯利——下一位，請。

We'll take our next question from Mark Schoenebaum with ISI Group.

我們將回答 ISI Group 的 Mark Schoenebaum 提出的下一個問題。

Yes, thank you very much for taking my question. I appreciate it. On diabetes, I was wondering if you could -- and if you already said this, I apologize for missing it. But, could you tell us what you were able to realize in price for the DPP-4 franchise if possible in the quarter? In the US, most importantly, if possible. Number two, I'd love to get your perspective on the increased rates of hospitalizations for heart failures in the Saver trial? Whether or not you think that's going to generate any kind of regulatory scrutiny? And then, finally, on [NEVO], the upcoming potentially pivotal phase II, third-line refractory squamous trial? What level of response would you define as success in that trial? Thank you very much.

是的，非常感謝您提出我的問題。我很感激。關於糖尿病，我想知道你是否可以——如果你已經說過了，我很抱歉錯過了。但是，您能否告訴我們，如果可能的話，本季度您能夠實現 DPP-4 特許經營權的價格是多少？如果可能的話，最重要的是在美國。第二，我很想听聽您對 Saver 試驗中因心力衰竭住院率增加的看法？您是否認為這會引起任何形式的監管審查？最後，關於[NEVO]，即將到來的潛在關鍵的二期、三線難治性鱗狀細胞癌試驗？您將何種程度的反應定義為該試驗的成功？非常感謝。

Okay. So, do you want to take, Francis, the question on Saver?

好的。那麼，弗朗西斯，你想接受關於保護者的問題嗎？

Yes. Thank you. Thank you, Mark. As you know, one component of our secondary endpoint hospitalization for heart failure did occur statistically more than the untreated group. But, it is important to note, I think that there was no increased risk of death due to heart failure overall, and in patients who entered the trial with a history of heart failure, there was no statistical difference between the treatments and the primary endpoint. So, we've been discussing with consultants about what this may mean, and we will be -- we've had discussions with the regulators -- and, we'll be making submission of this data to see whether any change to the labeling will come. That will be happening early next year.

是的。謝謝。謝謝你，馬克。如您所知，我們的次要終點因心力衰竭住院的一個組成部分在統計上確實比未治療組發生得更多。但是，值得注意的是，我認為總體而言，心力衰竭導致的死亡風險並未增加，並且在有心力衰竭病史進入試驗的患者中，治療方法與主要終點之間沒有統計學差異。因此，我們一直在與顧問討論這可能意味著什麼，我們將 - 我們已經與監管機構進行了討論 - 我們將提交這些數據，看看標籤是否有任何變化將會來。這將在明年初發生。

The -- I think it's important to also mention that if you take the Saver trial overall, there was clearly some benefits there in terms of diabetic control. Well, that wasn't the point of the trial. It was very reassuring from that perspective to the patients treated with Onglyza had better control. It was reassuring data around pancreatitis, even though the numbers were small in the end, and pancreatic cancer. Overall, we felt the Saver trial did inform quite considerably on the use of DPP-4 inhibitors, specifically Onglyza.

我認為還必須提到的是，如果您總體上進行 Saver 試驗，就會發現在糖尿病控制方面顯然有一些好處。好吧，這不是審判的重點。從這個角度來看，接受 Onglyza 治療的患者得到更好的控制是非常令人放心的。儘管最終的數字很小，但有關胰腺炎和胰腺癌的數據令人放心。總體而言，我們認為 Saver 試驗確實為 DPP-4 抑製劑（特別是 Onglyza）的使用提供了相當多的信息。

As far as squamous is concerned -- unfortunately, like all these things, it will depend exactly on what the data we see. We think, and I'll repeat -- it's very important to consider that this is a patient population with no other options at all at the present time, and that it's a very important aspect of this to see what the long-term durable response rate is, not just the overall response rate. We think that's important. Thank you.

就鱗狀細胞而言——不幸的是，就像所有這些事情一樣，這將完全取決於我們看到的數據。我們認為，我會重複一遍——考慮到這是一個目前根本沒有其他選擇的患者群體，這一點非常重要，而且這是一個非常重要的方面，看看長期持久的反應是什麼率，而不僅僅是總體響應率。我們認為這很重要。謝謝。

Mark, I'll just -- I think your question was more related to the US in regard to price. Overall, as we think of the Onglyza franchise, we continue to be at roughly parity with Januvia, and we did take a 5% facial price increase in August of this year.

馬克，我認為你的問題與美國的價格更相關。總體而言，當我們考慮 Onglyza 特許經營權時，我們仍然與 Januvia 大致持平，並且我們在今年 8 月確實將面部價格上漲了 5%。

Thanks, Mark. Leslie, can we go to the next questions, please.

謝謝，馬克。萊斯利，我們可以進入下一個問題嗎？

We'll take our next question from Jami Rubin with Goldman Sachs.

我們將回答高盛的賈米·魯賓 (Jami Rubin) 提出的下一個問題。

Thank you. I just have a couple of questions. Lamberto, first to you, I guess given that the significant commitment to immuno-oncology and the 25 trials on going with nivolumab and others, I'm just wondering if -- are you signaling to investors that we should assume a change in the rate of growth in R&D different from what we've seen the past couple of years?

謝謝。我只有幾個問題。Lamberto，首先對你來說，我想考慮到對免疫腫瘤學的重大承諾以及與納武單抗和其他藥物一起進行的 25 項試驗，我只是想知道你是否向投資者發出信號，表明我們應該假設利率發生變化研發的增長與我們過去幾年看到的不同嗎？

And, my second question relates to the hep C program, I'm not sure who will take this. But, if you could just help us to think about the commercial opportunity in Japan from your all-oral, dual regimen? The reason why I think this is tough for us to figure out is that telaprevir was a big disappointment in Japan even though it produced much higher cure rates from peg/riba. Your combination obviously excludes peg/riba, so how should we think about the commercial uptake, pricing, et cetera? And then, secondly, how long do you expect to be on that market without competitors which, you know, as I understand, will be on your heels? Thanks very much.

而且，我的第二個問題與 hep C 計劃有關，我不確定誰會接受這個。但是，您能否幫助我們思考一下您的全口服雙重療法在日本的商業機會？我認為我們很難弄清楚這一點的原因是特拉匹韋在日本令人非常失望，儘管它通過 peg/riba 產生了更高的治愈率。您的組合顯然不包括掛鉤/利巴，那麼我們應該如何考慮商業吸收、定價等？其次，你預計在沒有競爭對手的情況下在這個市場上呆多久，據我所知，競爭對手會緊隨你的腳步？非常感謝。

We will handle the Japan question, and Jami, I will speak about expenses. Thank you for this question because this allows me to expand on the subject of investments that both Charlie and I mentioned in our remarks. Let me say that we will continue to invest to support this immuno-oncology portfolio, and we will continue to invest behind Eliquis, hep C, and diabetes. They -- all this -- that we gather resources they deserve, and this will increase our expansion. Mostly the commercial expansions, because within R&D, we have a number of programs that are ending now, and therefore, we will have resources coming from within R&D to finance the additional expansions that immuno-oncology especially will require. And, they are significant, by the way. In commercial, we have already eliminated a lot of the expenses behind the old products, and therefore, we'll speak about commercial -- increasing commercial expenses. We just -- we will be ready to launch NEVO, and we will continue to support Yervoy, and as we said, Yervoy will launch in first-line in Europe. We will expand the commercial activities behind Eliquis in the US in the early launches, and we will launch outside the US in the most recent countries, and then Charlie will speak about the investments that will be required by the launch of hep C in Japan.

我們將處理日本問題，賈米，我將談論費用問題。感謝您提出這個問題，因為這使我能夠擴展查理和我在發言中提到的投資主題。我要說的是，我們將繼續投資支持這個免疫腫瘤產品組合，我們將繼續投資 Eliquis、丙肝和糖尿病。他們——所有這一切——讓我們收集他們應得的資源，這將增加我們的擴張。主要是商業擴張，因為在研發領域，我們有許多項目現在即將結束，因此，我們將擁有來自研發部門的資源來資助免疫腫瘤學特別需要的額外擴張。順便說一句，它們很重要。在商業方面，我們已經消除了很多舊產品背後的費用，因此，我們將談論商業——增加商業費用。我們只是——我們將準備好推出 NEVO，我們將繼續支持 Yervoy，正如我們所說，Yervoy 將在歐洲一線推出。我們將在早期推出中擴大 Eliquis 在美國的商業活動，我們將在美國以外的最近國家推出，然後查理將談論在日本推出丙型肝炎所需的投資。

And, finally, we have Forxiga hopefully approved next year, and so we will launch Forxiga in the US. Having said that, we are extremely aware -- my management and I are extremely aware of how important it is to deliver short-term results. And, we will deliver them, but we consider equally, if not even more important, to build a solid foundation for sustained, long-term growth. So, we will devote resources, in summary as I said, to all the great opportunities we have. Charlie, you want to talk about -- .

最後，Forxiga 希望明年獲得批准，因此我們將在美國推出 Forxiga。話雖如此，我們非常清楚——我和我的管理層都非常清楚交付短期成果的重要性。而且，我們將實現這些目標，但我們同樣認為，甚至更重要的是，為持續、長期的增長奠定堅實的基礎。因此，正如我所說，我們將把資源投入到我們擁有的所有巨大機會上。查理，你想談談——。

Yes, thanks for your question, Jami. As Lamberto mentioned in his opening comments, we are very can excited about our opportunity to bring the first, all-oral hep C regimen to market in Japan with our genotype-1b strategy. Our registrational phase 3 study of daclatasvir and [asaneprovir] in Japanese genotype 1b patients will be presented at AASLD in a couple of weeks, and we plan to file in Japan later this quarter.

是的，謝謝你的提問，賈米。正如 Lamberto 在開場白中提到的那樣，我們非常高興有機會通過我們的基因型 1b 策略將第一個全口服丙型肝炎治療方案推向日本市場。我們在日本基因型 1b 患者中進行的 daclatasvir 和 [asaneprovir] 註冊 3 期研究將於幾週後在 AASLD 上提交，我們計劃本季度晚些時候在日本提交申請。

Remember that there are about 1.2 million people infected with hepatitis C in Japan, and about 70% of them have genotype 1b. These patients are largely elderly, and many either cannot tolerate the current interferon-based standard of care or are ineligible to receive it. So, that speaks to the real opportunity and why the current standard care has not done as well, to your earlier point. And, finally, we believe we have up to an 18-month lead on both [Advi] and Gilead in Japan.

請記住，日本約有 120 萬人感染丙型肝炎，其中約 70% 的基因型為 1b。這些患者大多是老年人，許多人要么無法忍受當前基於乾擾素的護理標準，要么沒有資格接受該治療。因此，這說明了真正的機會，以及為什麼當前的標準護理效果不如您之前的觀點。最後，我們相信我們在日本的 [Advi] 和吉利德領先優勢長達 18 個月。

Jami, thanks for the questions. Leslie, can we go to the next one, please.

賈米，謝謝你的提問。萊斯利，我們可以轉到下一個嗎？

We'll take our next question from Chris Schott with JPMorgan.

我們將回答摩根大通的克里斯·肖特 (Chris Schott) 提出的下一個問題。

Great, thanks for the questions. Just had three here. I guess, first, we've seen your competitors in the PD-1 space focusing a bit more on PD-L1 status, particularly in non-small cell lung cancer. Can you just elaborate on your view on this dynamic, and what implications it has either to the size of the market or the competitive positioning of NEVO?

太好了，謝謝你的提問。剛在這裡吃了三個。我想，首先，我們看到你們在 PD-1 領域的競爭對手更多地關注 PD-L1 狀態，特別是在非小細胞肺癌方面。您能否詳細闡述一下您對這一動態的看法，以及它對市場規模或 NEVO 的競爭定位有何影響？

Second on Eliquis, with this slower launch -- I know things are accelerating a bit now. But, have you changed your internal peak sales assumptions on the product based on the experience thus far?

其次是 Eliquis，由於發布速度較慢，我知道現在事情正在加速。但是，您是否根據迄今為止的經驗改變了對產品的內部峰值銷售假設？

And then, finally, switching to diabetes in light of some of the moves by [Pairs] to narrow their formulary to one or two products in some of these major categories, can you just talk about how formulary dynamics play out in the space over time? And, are things just becoming more challenging with Pairs on that portion of your business? Thank you very much.

最後，鑑於 [Pairs] 採取了一些舉措，將其處方集縮小到其中一些主要類別中的一到兩種產品，轉向糖尿病，您能談談隨著時間的推移，處方集動態如何在該領域發揮作用嗎？ ？而且，在您的這部分業務中，Pairs 是否會變得更具挑戰性？非常感謝。

I have a very quick answer to your question on Eliquis. No, our peak sales are not changed, and we are still very confident about Eliquis and what that product can achieve.

我對您關於 Eliquis 的問題有一個非常快速的回答。不，我們的峰值銷量沒有改變，我們仍然對 Eliquis 以及該產品能夠實現的目標充滿信心。

A word about the PD-L1. Now, as you remember Chris, we reported biomarker data last year in the New England Journal of Medicine that suggested PD-L1 might be a predictive marker for the activity of nivolumab. And, as a result, we've been studying this throughout our broad phase III program. Now, it's important to note that our clinical development plans are designed to explore both the potential predictive biomarker and to ensure that the patients who may benefit are not excluded if they're biomarker-negative. Our objective is to conduct well-controlled phase III studies that will establish the validity of any biomarker based on overall survival. Again, it's an important element. It's not just about response rate -- overall survival.

關於 PD-L1 的一句話。現在，克里斯，我們去年在《新英格蘭醫學雜誌》上報導了生物標誌物數據，表明 PD-L1 可能是納武單抗活性的預測標誌物。因此，我們在整個第三階段項目中一直在研究這個問題。現在，值得注意的是，我們的臨床開發計劃旨在探索潛在的預測生物標誌物，並確保生物標誌物陰性的患者不會被排除在外。我們的目標是進行嚴格控制的 III 期研究，以根據總生存期確定任何生物標誌物的有效性。這又是一個重要的因素。這不僅僅是反應率——總體生存率。

And, I think finally it's hard to predict exactly how this will come out because, as you understand, the approach for developing immunotherapies is rather different from what we would use in targeted medicines. In immuno-oncology, we're really targeting the host and the interaction of the tumor in the host's immune system as opposed to tumor mucations such as KRAS or BRAF. That being said, I think I would say as far as we're concerned in BMS, we have a lot of experience with KRAS and [urbitags]. We do understand what's necessary to have a pharmaco-diagnostic properly validated and to develop the data that's going to be required for the regulator to make a decision.

而且，我認為最終很難準確預測這將如何發生，因為正如你所知，開發免疫療法的方法與我們在靶向藥物中使用的方法相當不同。在免疫腫瘤學中，我們真正針對的是宿主以及宿主免疫系統中腫瘤的相互作用，而不是 KRAS 或 BRAF 等腫瘤突變體。話雖這麼說，我想我想說，就我們 BMS 而言，我們在 KRAS 和 [urbitags] 方面擁有豐富的經驗。我們確實了解正確驗證藥物診斷以及開發監管機構做出決策所需的數據的必要性。

I think it's -- we're generating the data. We'll see what the data is, and we'll debate and collaborate with the regulators to provide perhaps a biomarker or perhaps an accelerated approval if that's -- accelerated submission if that's appropriate. Thank you.

我認為我們正在生成數據。我們將了解數據是什麼，我們將與監管機構進行辯論和合作，以提供生物標誌物，或者可能加速批准（如果合適的話）加速提交。謝謝。

This is Giovanni. Let me make a comment on diabetes access. Clearly, as you know, this is a very big market, very competitive, and crowded and obviously, it's an area of focus for payers, and that will not change going forward. From our perspective, this is the one area where, in fact, having a broad portfolio really creates a good platform for us to negotiate with payers through the three classes.

這是喬瓦尼。讓我對糖尿病的獲取發表評論。顯然，如您所知，這是一個非常大的市場，競爭非常激烈，而且很擁擠，顯然，這是付款人關注的領域，而且這一點未來不會改變。從我們的角度來看，事實上，在這一領域，擁有廣泛的投資組合確實為我們通過這三個類別與付款人進行談判創造了一個良好的平台。

When we look at our competitive position, our access with Bydureon is improving and following -- and in DPP-4s following the loss of Caremark at the end of last year, our access position this year with Onglyza and Kombiglyze has been good and stable. Going into next year, as you probably know, we had two very important wins with ESI which is a very important customer. Both with respect to our position with Onglyza and DPP-4s, and most importantly, with Bydureon as the preferred GLP-1. It continues to be an area of focus for us, but we're working very actively. We have a good portfolio, and we'll be able to continue to compete.

當我們審視我們的競爭地位時，我們對 Bydureon 的訪問正在改善和跟進 - 在去年年底失去 Caremark 後​​的 DPP-4 中，我們今年對 Onglyza 和 Kombiglyze 的訪問地位一直良好且穩定。進入明年，您可能知道，我們與 ESI 取得了兩個非常重要的勝利，ESI 是一個非常重要的客戶。就我們對 Onglyza 和 DPP-4 的立場而言，最重要的是，Bydureon 是首選的 GLP-1。它仍然是我們關注的一個領域，但我們正在非常積極地工作。我們擁有良好的產品組合，我們將能夠繼續競爭。

Leslie, can we go to the next question, please.

萊斯利，我們可以進入下一個問題嗎？

We'll take our next question from Alex Arfaei from BMO Capital Markets.

我們將回答來自 BMO 資本市場的 Alex Arfaei 的下一個問題。

Good morning, I thank you for taking the questions. First, for Francis, I realize it's a bit early, but could you please comment on some of the other cancer immunotherapies that you have in the clinic and roughly when we can expect data? And then, a follow up on Forxiga. Is the FDA Adcom later this year simply a follow-up to earlier issues because it doesn't seem like what is expected for lidies and pugliafozan. Thank you.

早上好，感謝您提出問題。首先，對於弗朗西斯來說，我意識到現在有點早，但是您能否評論一下您在診所中使用的其他一些癌症免疫療法以及我們大致何時可以期待數據？然後是 Forxiga 的後續行動。今年晚些時候的 FDA Adcom 是否只是早期問題的後續行動，因為它似乎並不像對 Lidies 和 pugliafozan 的預期那樣。謝謝。

Alex, let me just be very brief. We have ongoing trials with combinations of [ipuliminab], nivolumab with [antikeer] and IL-21. Those are ongoing exploratory trials, so it's very hard to say. They are [evendrium] trials, so we'll see when those come out. And, I think excitingly we're going to have before the end of the year, the lag 3 entering the clinic. And again, those studies are yet to start. Again, very exciting.

亞歷克斯，讓我簡單說一下。我們正在進行 [ipuliminab]、nivolumab 與 [antikeer] 和 IL-21 組合的試驗。這些都是正在進行的探索性試驗，所以很難說。它們是[evendrium]試驗，所以我們會看看它們什麼時候出來。而且，我認為令人興奮的是，我們將在今年年底之前讓 lag 3 進入臨床。再說一遍，這些研究尚未開始。再次，非常令人興奮。

The -- I'm sorry. The [ad forum] for Forxiga, we know we have an Adcom in December that the FDA -- I think it's important to note has been working through despite the government shutdown. We feel we've answered all the questions that came from the CRL, and we added additional data to the submission. Some of that was presented at the EASD in September, and some more on hypertension will be presented at the AHA in November. And, this will be part of the Adcom.

對不起。Forxiga 的[廣告論壇]，我們知道我們在 12 月有一個 Adcom，FDA——我認為值得注意的是，儘管政府關閉，但 FDA 一直在進行工作。我們認為我們已經回答了 CRL 中提出的所有問題，並且我們在提交的內容中添加了額外的數據。其中一些內容已在 9 月份的 EASD 上發表，更多有關高血壓的內容將在 11 月份的 AHA 上發表。而且，這將成為 Adcom 的一部分。

Thanks, Alex, for those questions. Can we go to the next one, please.

謝謝亞歷克斯提出這些問題。我們可以轉到下一個嗎？

We'll take our next question from Tim Anderson with Sanford Bernstein.

我們將回答蒂姆·安德森和桑福德·伯恩斯坦提出的下一個問題。

If I can go back to biomarkers. Your positioning over -- at least initially was a little bit uncertain whether L1 expression would be highly predictive. But, when I look at the data that has continued to come out, it seems like that body of evidence does increasingly support that L1 expression predicts efficacy. And, I'm -- I guess my question to you is has your thinking changed over time? I know your development programs are set up to look at it, but are you kind of warming up the more data you see to the idea of L1 being predictive?

如果我能回到生物標誌物的話。你的定位——至少最初有點不確定 L1 表達是否具有高度預測性。但是，當我查看不斷出現的數據時，似乎越來越多的證據確實支持 L1 表達預測功效。而且，我想我對你的問題是你的想法隨著時間的推移而改變嗎？我知道你們的開發計劃就是為了研究這個問題而設立的，但是隨著看到的數據越來越多，你們是否對 L1 具有預測性的想法產生了興趣？

And then, related to this, what other predictive biomarkers are you looking at? Or, is anyone in the industry looking at that seems promising? And then, the last question is, going back to your comment, you said the next public data downstream of world lung conference would be ASCO. But, I'm imagining you'll have top line results of various sorts in between. If that's right, maybe you could outline what some of these would include. I would imagine that would be the phase II lung cancer data and the combo data with [idbe], for example.

然後，與此相關，您還在尋找哪些其他預測生物標誌物？或者，業內有人認為這看起來很有希望嗎？然後，最後一個問題是，回到您的評論，您說世界肺會議下游的下一個公開數據將是 ASCO。但是，我想你會得到介於兩者之間的各種頂線結果。如果這是正確的，也許您可以概述其中一些內容。例如，我想這將是 II 期肺癌數據和 [idbe] 的組合數據。

Thank you,, Tim. So, I think it's fair to say our data and others suggest that the PD-L1 biomarker will enrich for response. However, it's also very clear that there's a number of patients who are apparently PD-L1-negative who also respond. I think it's important that we don't exclude those patients from the potential benefit. And, I think it's particularly important to say also that the data set that will evolve, and we'll get some sense of the long-term response. But, that being said, we're leaving ourselves open to take the data we generate, and in discussions with the regulators, to come up with the best approach.

謝謝你，蒂姆。因此，我認為可以公平地說，我們的數據和其他數據表明 PD-L1 生物標記物將豐富反應。然而，也非常清楚的是，有許多明顯 PD-L1 陰性的患者也有反應。我認為重要的是我們不要將這些患者排除在潛在的益處之外。而且，我認為特別重要的是，數據集將會不斷發展，我們將對長期反應有所了解。但是，話雖如此，我們仍願意接受我們生成的數據，並與監管機構討論，以提出最佳方法。

Francis, can I make a comment, please. Not obviously very scientific, but aren't others drawing conclusions a bit too early at this point? I mean, don't we need more patients -- more experience before we draw final conclusions on these very important aspects?

弗朗西斯，我可以發表評論嗎？顯然不是很科學，但其他人現在下結論是不是有點太早了？我的意思是，在我們對這些非常重要的方面得出最終結論之前，我們難道不需要更多的患者——更多的經驗嗎？

Well, I think that's certainly our point of view. I think we're leaving ourselves open to go with a biomarker if that's what the data shows, but we also want to make sure that we -- make sure this therapy is open to the broadest number of patients. I think as far as other predictive biomarkers are concerned, there's a lot of work ongoing in terms of understanding that interaction between the host, the tumor. And, I don't think at this point I want to share any of that data, but it's certainly an area of considerable work both internally within BMS and externally with our collaborators.

嗯，我認為這當然是我們的觀點。我認為，如果數據顯示的是這樣的話，我們將願意使用生物標誌物，但我們也想確保我們——確保這種療法向最廣泛的患者開放。我認為就其他預測生物標誌物而言，在理解宿主與腫瘤之間的相互作用方面正在進行大量工作。而且，我認為目前我不想分享任何這些數據，但這無疑是 BMS 內部和外部與我們的合作者進行大量工作的領域。

As far as the next public data, let me reiterate what I said. The lung data -- the two-year lung data from the -- will be presented from 003 at the world lung conference in Sydney in a couple of weeks. I think, later this week in fact. And then, we'll be getting considerable amounts of data over the next six months within BMS, but the next time we're planning to present publicly will be at ASCO, and there will be data sets -- probably further data sets on 003 survival. 004, which is the combination, and potentially the second-line -- third-line phase II study in non-small cell line squamous cell.

至於接下來的公開數據，我再說一遍。肺部數據——來自 003 的兩年肺部數據——將於幾週後在悉尼舉行的世界肺部會議上公佈。我想，實際上是在本週晚些時候。然後，我們將在接下來的六個月內在 BMS 內獲得大量數據，但下一次我們計劃公開展示將在 ASCO 上，並且將會有數據集——可能是關於 003 的更多數據集生存。004，這是一種組合，可能是非小細胞系鱗狀細胞的二線-三線 II 期研究。

Thanks. And, Tim, you're right. We will also have the combo phase I long study in-house hopefully by the end of the year.

謝謝。而且，蒂姆，你是對的。希望到今年年底，我們還將在內部進行長期研究的組合第一階段。

Yes, both the non-small cell line and renal cell.

是的，非小細胞系和腎細胞。

So, can we go to the next question please, Leslie?

那麼，我們可以進入下一個問題嗎，Leslie？

We'll take our next question from Andrew Baum with Citi.

我們將接受花旗銀行安德魯·鮑姆 (Andrew Baum) 提出的下一個問題。

Many thanks. Three questions, please. Firstly, could you give us an update on Urelumab, your anti-CD137? When should we expect seeing some of the data from your ongoing trials?

非常感謝。請教大家三個問題。首先，您能給我們介紹一下您的抗 CD137 Urelumab 的最新情況嗎？我們什麼時候可以看到你們正在進行的試驗的一些數據？

Second, could you help us understand the lower pneumonitis grade 3 rates that you're seeing with nivolumab of late? To what extent is this just a function of patient selection and management, and actual facts when you start looking at combination therapies? The piece that benefits of PD-L1 targeted agent may look somewhat better? And then, finally how will the GBA decision on [galvis] reimbursements in Germany impact pricing of the class in the rest of Europe. Many thanks.

其次，您能否幫助我們了解您最近使用納武單抗觀察到的較低的 3 級肺炎發生率？當您開始考慮聯合療法時，這在多大程度上只是患者選擇和管理以及實際事實的函數？PD-L1靶向藥物的好處可能看起來更好一些？最後，GBA 關於德國 [galvis] 報銷的決定將如何影響歐洲其他地區的課程定價。非常感謝。

Andrew let me start. Urelumab, we have a couple of studies ongoing. They're exploratory studies. They're event-based studies. So, they will be probably reporting out some time in 2015, perhaps a little sooner. As far as the pneumonitis rates we're seeing, we're not seeing very high rates at all. We have seen with both PD-1 and our PD-L1, and it's very difficult with very small numbers I think to -- it's an important potential adverse event, but it doesn't happen very often. And, we do have a -- we do expect as the numbers grow to have a better sense of that. But, I think it's very hard at this point to interpret at all about whether it will be a greater or lesser with either PD-1 or PD-L1.

安德魯讓我開始。Urelumab，我們正在進行幾項研究。它們是探索性研究。它們是基於事件的研究。因此，他們可能會在 2015 年的某個時間發布報告，也許會更早一點。就我們所看到的肺炎發病率而言，我們並沒有看到很高的發病率。我們已經看到了 PD-1 和 PD-L1，我認為在極少數情況下這是非常困難的——這是一個重要的潛在不良事件，但它並不經常發生。而且，我們確實希望隨著數字的增長對此有更好的認識。但是，我認為目前很難解釋 PD-1 或​​ PD-L1 的大小是更大還是更小。

So, regarding the GBA, you probably all heard that on October 1, a ruling was made after [class III view] of all the DPP-4s and their combinations. So, we're very pleased there to see that in a very difficult context in Germany for diabetes, our products -- both Onglyza, and Komboglyze -- were given an added minor benefit over usage metformin. So, that happened with [Vidagleetin]. [Galvis], as you mentioned did not get any benefit so what happens now in the process to understand what could be the outcome is that negotiations on pricing are going to start with [the fig phones]. Obviously, each Company will negotiate their pricing. And, we'll see then the outcome. For us, we feel that with an additional benefit, we will be able to conclude pricing negotiation relatively quickly, and we cannot speculate what Vidagleetin will be doing, but we will be ready to seize any opportunities in face (inaudible).

所以，關於GBA，你們可能都聽說過，10月1日，在所有DPP-4及其組合的[III級視圖]之後做出了裁決。因此，我們非常高興地看到，在德國糖尿病非常困難的情況下，我們的產品（Onglyza 和 Komboglyze）比使用二甲雙胍獲得了額外的微小好處。[Vidagleetin] 就發生了這種情況。[Galvis]，正如您提到的，沒有獲得任何好處，因此在了解可能結果的過程中現在發生的事情是，定價談判將從[無花果手機]開始。顯然，每家公司都會協商定價。而且，我們會看到結果。對於我們來說，我們認為有了額外的好處，我們將能夠相對較快地完成定價談判，我們無法推測 Vidagleetin 會做什麼，但我們將準備好抓住面臨的任何機會（聽不清）。

Thanks, Andrew. Can we go to the next question, please, Leslie?

謝謝，安德魯。萊斯利，我們可以進入下一個問題嗎？

We'll take our next question from Steve Scala with Cowen.

我們將回答 Steve Scala 和 Cowen 提出的下一個問題。

Thank you very much. I have two follow-ups from points made on the second-quarter call. I apologize if you've already given this piece of information, but what is the share of Eliquis among cardiologists? I think on the second-quarter call you said it was about 15%.

非常感謝。我對第二季度電話會議的要點有兩點後續行動。如果您已經提供了這條信息，我很抱歉，但 Eliquis 在心髒病專家中的份額是多少？我想你在第二季度電話會議上說過大約是 15%。

And, on nivolumab on the second-quarter call, you stated that there was no more public disclosures this year when indeed you do have this two-year update that you referenced a couple times on the call coming this week or next week. Three months ago, you probably didn't have the two-year data, but now you do -- the two-year update. I'm wondering if receipt of the data changed your language or characterization of the event? Thank you.

而且，在第二季度的電話會議上，關於納武單抗，您表示今年沒有更多的公開披露，而實際上您確實有這個兩年的更新，您在本週或下週的電話會議上多次提到了這一點。三個月前，您可能沒有兩年的數據，但現在您有了——兩年的更新。我想知道收到數據是否改變了您的語言或事件的描述？謝謝。

This is Giovanni. Let me start with the cardiology NBRX share. The latest data point we have is a 18.9% share for Eliquis from a new patient share in cardiology.

這是喬瓦尼。先從心髒病學NBRX的分享開始吧。我們掌握的最新數據顯示，Eliquis 在心髒病學領域的新患者份額中佔據了 18.9% 的份額。

Steve, it's Francis Cuss. Just to say that we always planned to present the long-term data at the world lung conference in Sydney, and you're right. That's not new. That was always the plan. But, you're right about the next date of that is ASCO.

史蒂夫，我是弗朗西斯·庫斯。只是說，我們一直計劃在悉尼舉行的世界肺部會議上展示長期數據，你是對的。這並不新鮮。這一直是計劃。但是，您對下一個日期是 ASCO 的看法是正確的。

And, I think part of that Steve was the view that this is data from an existing study that had already been presented, so in terms of -- it wasn't -- we weren't presenting data from any new studies the remainder of this year. Can we go to the next question, please, Leslie?

而且，我認為史蒂夫的部分原因是認為這是來自已經提出的現有研究的數據，因此就 - 事實並非如此 - 我們沒有提供任何新研究的剩餘數據今年。萊斯利，我們可以進入下一個問題嗎？

We'll take our next question from [Vanel] Divan with Credit Suisse.

我們將回答瑞士信貸銀行 [Vanel] Divan 提出的下一個問題。

Thanks for taking my questions. I've got one on the pipeline and one on the marketed [cross] side. So, on the marketed side, about Orencia, you mentioned the sub-Q formulation. And, I think you said it was about 1/3 of the use is now with that formulation. I think that's consistent with what we were hearing too. Just wondering if you're sensing that that's helping physicians get more comfortable moving Orencia up earlier in the algorithm? And maybe, what else we can expect in terms of life cycle management?

感謝您回答我的問題。我有一款正在研發中，一款正在上市（交叉）。因此，在營銷方面，關於 Orencia，您提到了 sub-Q 配方。而且，我想您說過，現在大約有 1/3 的使用量是採用該配方。我認為這也與我們聽到的一致。只是想知道您是否感覺到這有助於醫生更輕鬆地在算法中將 Orencia 移至更早的位置？也許，在生命週期管理方面我們還能期待什麼？

And then, on NEVO, I realize it's a bit early to ask this question, but we've been getting this question a lot ourselves -- it's around the pricing side. Seems to be a lot of wide range of assumptions there in terms of how the combo is priced. I realize it's early, but is there anything you could say in terms of directionally how we should be thinking about that? What your framework is in terms of thinking about pricing just because it is such a key variable in our model, and I think others as well.

然後，在 NEVO 上，我意識到現在問這個問題有點早，但我們自己也經常被問到這個問題——這是圍繞定價方面的。關於組合的定價方式似乎有很多廣泛的假設。我意識到現在還為時過早，但是您能就我們應該如何思考這個問題說些什麼嗎？您在考慮定價方面的框架是什麼，因為它是我們模型中的一個關鍵變量，我認為其他變量也是如此。

You're right. The pricing on NEVO is a very important subject, but we are not willing to discuss it today. We are devoting a lot of attention to that subject. We are discussing internally. We are collecting the right data, and obviously, we will make the decision over time. And, we'll announce it at the very last minute.

你說得對。NEVO 的定價是一個非常重要的話題，但我們今天不願意討論。我們對這個主題投入了大量的注意力。我們正在內部討論。我們正在收集正確的數據，顯然，我們會隨著時間的推移做出決定。而且，我們將在最後一刻宣布這一消息。

So, let me be -- let me start with Orencia in the US. You're right. We had a very good quarter in the US. The brand was up 17% versus previous year. The sub-Q formulation was up significantly both versus prior year and sequentially over the previous quarter in the US. That is happening exactly as you mentioned. As a result of physicians feeling more and more comfortable in using the sub-Q formulation earlier in the treatment paradigm. And, in fact, even our promotional strategy has shifted really to promoting the value of Orencia's sub-Q as a first line biologic. As you may have seen and know, we're now the third-most prescribed sub-Q agent in the US, and the trends continue to be positive.

那麼，讓我從美國的奧倫西亞開始吧。你說得對。我們在美國度過了一個非常好的季度。該品牌比去年增長了 17%。美國的 sub-Q 配方與上年相比以及上一季度的環比均顯著上升。正如你所提到的，這種情況正在發生。結果是，醫生在治療範例的早期使用 sub-Q 配方時感覺越來越舒服。事實上，甚至我們的促銷策略也已真正轉向宣傳 Orencia 的 sub-Q 作為一線生物製劑的價值。正如您可能已經看到並知道的那樣，我們現在是美國處方量第三大的 sub-Q 藥物，而且趨勢仍然積極。

International and Europe things are going very well for Orencia. In Europe particularly, the market was 70%-plus in sub-Q so having now with the addition and reimbursement progressively again, but in most markets for sub-Q, it is very helpful to our growth. We are growing by a more than 40% in the last quarters. So, similarly, we see more and more use, first line -- first line biologic switch [first]. And, more and more now we're thinking about the first-line biologic. So, it is good. This is a progression. What also we have noticed in last quarter is that our IV business seems to be bottoming up and stabilizing and re-growing, so that's also good because we have additional growth coming from new patients, not just cannibalization.

奧倫西亞的國際和歐洲事務進展順利。特別是在歐洲，市場在次季度增長了 70% 以上，因此現在再次逐步增加和報銷，但在大多數市場的次季度，這對我們的增長非常有幫助。過去幾個季度我們的增長率超過 40%。因此，類似地，我們看到越來越多的使用，第一線——第一線生物開關[第一]。而且，現在我們越來越多地考慮一線生物製劑。所以，這很好。這是一個進步。我們在上個季度還注意到，我們的靜脈注射業務似乎正在觸底回升、穩定並重新增長，所以這也很好，因為我們的額外增長來自新患者，而不僅僅是蠶食。

Okay. Thanks. I think we have time Leslie for one more question.

好的。謝謝。我想我們還有時間讓萊斯利再問一個問題。

We'll take our final question from Greg Gilbert with Bank of America.

我們將回答美國銀行格雷格·吉爾伯特的最後一個問題。

Thank you. For Giovanni and Beatrice, I was curious how much does your oncology commercial effort need to expand if NEVO is approved in lung cancer? And, when would you begin that expansion? And, for Charlie, on tax rate -- wondering what a good tax rate to use longer term would be now that you've had some more time post-Plavix LOE? And, does that new rate give you adequate flexibility to raise the dividend if you were to choose so? And, to buy back stock if you were to choose to do so again in the future? Just wondering how much flexibility is left within your new tax structure. Thanks.

謝謝。對於 Giovanni 和 Beatrice，我很好奇如果 NEVO 在肺癌領域獲得批准，你們的腫瘤商業工作需要擴大多少？而且，你什麼時候開始擴張？而且，對於 Charlie 來說，關於稅率，既然您在 Plavix LOE 後已經有了更多時間，那麼想知道長期使用的良好稅率是多少？而且，如果您選擇的話，新的利率是否可以為您提供足夠的靈活性來提高股息？而且，如果您將來選擇再次回購股票，會回購股票嗎？只是想知道新的稅收結構中還剩下多少靈活性。謝謝。

So, very quickly on the US. As you know, we have a very, very good organization in the US with a strong and diversified portfolio. We are well resourced for Yervoy and melanoma. Obviously, we are thinking about lung. That's a bigger opportunity. It's a larger prescriber base, and we will be ready to launch that as well. So, we clearly will invest and grow the sales organization in the US.

所以，很快就到了美國。如您所知，我們在美國擁有非常非常優秀的組織，擁有強大且多元化的產品組合。我們對於耶沃伊和黑色素瘤擁有充足的資源。顯然，我們正在考慮肺。這是一個更大的機會。這是一個更大的處方者基礎，我們也將準備好推出它。因此，我們顯然將在美國投資和發展銷售組織。

And, as you know, lung is really a global issue from China to Japan to the US. So, the global team I'm working with all original team to assess in the next few years how much resources we need to be ready and stuff early on. It's clear that with the competitive landscape, we want to be ready and not to have to reorganize every year, each time we have an additional indication of additional rebuilding evolution. So, we are working on that very actively with all our regions.

而且，如您所知，肺確實是一個全球性問題，從中國到日本再到美國。因此，我正在與全球團隊的所有原始團隊合作，評估未來幾年我們需要提前準備好多少資源。顯然，在競爭格局下，我們希望做好準備，而不必每年都進行重組，每次我們都有額外的重建進展的跡象時。因此，我們正在與所有地區積極合作。

Yes, this is the new paradigm in oncology where we have multiple indications potentially coming very quickly, and therefore, we are thinking in the US, as Giovanni said, and outside of the US, as Beatrice said -- of creating an infrastructure and a structure that can -- doesn't need to be changed at every indication. And, also, we need to start very early with these new prescribers the education of the new prescribers. Remember the work we had to do with the melanoma prescribers at the beginning to familiarize them with immuno-oncology. Well, the same needs to be done now with a much broader base in the US and internationally to familiarize them with the immuno-oncology and the other lung specialists -- the long cancer prescribers.

是的，這是腫瘤學的新範式，我們有多種跡象可能很快就會出現，因此，正如喬瓦尼所說，我們正在考慮在美國，正如比阿特麗斯所說，在美國之外，創建基礎設施和結構可以——不需要在每次出現變化時都改變。而且，我們還需要很早就開始對這些新處方醫生進行教育。請記住我們一開始必須與黑色素瘤處方者一起做的工作，讓他們熟悉免疫腫瘤學。那麼，現在需要在美國和國際上建立更廣泛的基礎，讓他們熟悉免疫腫瘤學和其他肺部專家——長期癌症處方者。

Yes, Greg let me address your questions. On the tax rate, you may recall that we benefited in 2013 by having the double-up of the R&D tax credit from 2012. Going forward, our tax rate is very dependent upon where our earnings mix comes from, and we've said at least in the intermediate term, we view our tax rate in the high teens, mid- to high teens area. I can't give more than that. It's going to have to roll up the numbers and see where all the different earnings come from. As far as the dividend, that's an annual Board decision, and that's not one I can talk about at this point. And, in regard to share repurchases, I would just reinforce what I said in my opening comments is that we do not anticipate any share repurchases going forward at this time.

是的，格雷格讓我回答你的問題。關於稅率，您可能還記得，我們​​在 2013 年受益於比 2012 年雙倍的研發稅收抵免。展望未來，我們的稅率很大程度上取決於我們的收入組合來自哪裡，我們已經說過，至少在中期，我們認為我們的稅率處於高十幾歲、中高十幾歲地區。我不能給予更多。它必須匯總數字，看看所有不同的收入來自哪裡。至於股息，這是董事會的年度決定，目前我無法談論這一點。而且，關於股票回購，我想強調一下我在開場白中所說的話，即我們預計目前不會進行任何股票回購。

Okay. So, thank you, Charlie. Even though this is a decision of the Board, we are aware that the Board, and we are committed to the dividend. So, I know that this -- every comment we make on dividends might be misinterpreted. I don't want your comment to be misinterpreted. We are committed to the dividend, and the Board will decide on it quarter-by-quarter and year-over-year.

好的。所以，謝謝你，查理。儘管這是董事會的決定，但我們知道董事會和我們都致力於派發股息。所以，我知道我們對股息所做的每一個評論都可能被誤解。我不希望你的評論被誤解。我們致力於股息，董事會將按季度和逐年決定。

Let me conclude the session by repeating this is an important time for Bristol-Myers Squibb. We are returned to growth. Our pipeline progress and our balanced approach to delivering the results of today while laying the foundation for results of tomorrow. Taken together, Bristol-Myers Squibb is strong, and I believe I'm convinced we are well-positioned for the future. Thank you very much, and have a great day.

在結束本次會議時，我要重申，對於百時美施貴寶來說，這是一個重要時刻。我們又恢復了增長。我們的管道進展和我們平衡的方法來交付今天的成果，同時為明天的成果奠定基礎。總而言之，百時美施貴寶很強大，我相信我們已經為未來做好了充分的準備。非常感謝，祝您有美好的一天。

Okay. That's going to conclude the call. Thanks everybody for joining. As always, the IR team here at Bristol is available for follow-ups. Thank you.

好的。通話就到此結束。感謝大家的加入。與往常一樣，布里斯托爾的 IR 團隊隨時提供後續服務。謝謝。

This concludes the third-quarter earnings 2013 earnings release conference call. We thank you for your participation.

2013 年第三季度財報電話會議到此結束。我們感謝您的參與。