吉利德科學 (GILD) 2016 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the Gilead Sciences first-quarter 2016 earnings conference call. My name is Candace, and I will be your conference operator today. (Operator Instructions)

女士們、先生們，感謝各位的耐心等待，歡迎參加吉利德科學公司2016年第一季財報電話會議。我叫坎迪斯，今天我將擔任你們的會議接線生。（操作說明）

And as a reminder, this conference call is being recorded. I would now like to turn the call over to Patrick O'Brien, Vice President of Investor Relations. Please go ahead.

再次提醒大家，本次電話會議正在錄音。現在我將把電話交給投資人關係副總裁派崔克‧奧布萊恩。請繼續。

Thank you, Candace, and good afternoon, everyone. Just after market close today, a press release was issued with earnings results for the first quarter of 2016. The press release and detailed slides are available on the investor relations section of the Gilead website.

謝謝你，坎迪斯，大家下午好。今天股市收盤後不久，該公司發布了一份新聞稿，公佈了 2016 年第一季的獲利結果。新聞稿和詳細幻燈片可在吉利德公司網站的投資者關係部分查看。

Joining today's call will be John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; Paul Carter, Executive Vice President of Commercial Operations; and Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer.

參加今天電話會議的有：總裁兼執行長約翰·米利根；執行副總裁兼財務長羅賓·華盛頓；商業營運執行副總裁保羅·卡特；以及研發執行副總裁兼首席科學官諾伯特·比肖夫伯格。

Before we begin formal remarks, let me remind you that we'll be making forward-looking statements, including plans and expectations with respect to products, product candidates, financial projections, and the use of capital -- all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the latest SEC disclosure documents and recent press releases. In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call.

在我們正式發言之前，請允許我提醒各位，我們將發表一些前瞻性聲明，包括有關產品、候選產品、財務預測和資本使用的計劃和預期——所有這些都涉及某些我們無法控制的假設、風險和不確定性，並可能導致實際結果與這些聲明存在重大差異。有關這些風險的描述可以在最新的美國證券交易委員會披露文件和最近的新聞稿中找到。此外，吉利德不承擔更新本次電話會議中任何前瞻性聲明的義務。

Non-GAAP financial measures will be used to help you understand the Company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release as well as on the Gilead website.

我們將使用非公認會計準則財務指標來幫助您了解公司的基本業務表現。GAAP 與非 GAAP 的調整表已在盈利新聞稿以及吉利德網站上提供。

I will now turn the call over to John.

現在我將把通話轉給約翰。

Thank you, Patrick, and thank you, everyone, for joining us today. While we want to keep our remarks relatively brief to allow plenty of time of your questions, I do want to make a few comments about the first few months of 2016 and what I see as the outlook for the rest of the year.

謝謝派崔克，也謝謝各位今天蒞臨現場。雖然我們希望發言盡量簡短，以便留出充足的時間回答各位的問題，但我確實想就 2016 年前幾個月以及我對今年剩餘時間的展望發表一些看法。

Gilead's HIV franchise is off to a great start with the recent US FDA approvals of Odefsey and Descovy, which followed the approval of Genvoya late last year. Over the last six months, I've had the opportunity to talk with physicians and patients about the importance of having highly effective and safer options, especially for patients facing a lifetime of therapy.

吉利德的 HIV 產品線開局良好，最近 Odefsey 和 Descovy 獲得了美國 FDA 的批准，此前 Genvoya 已於去年底獲得批准。在過去的六個月裡，我有機會與醫生和患者探討了擁有高效且更安全的治療方案的重要性，特別是對於需要終身接受治療的患者而言。

With the approval of our three new regimens, we are now able to offer a range of options to address the diverse medical requirements of people with HIV, including those new to treatment, those who have been on therapy for a long time and have run short of options, and those who desire to switch medications for a variety of reasons.

隨著我們三種新療法的獲批，我們現在能夠提供一系列選擇，以滿足 HIV 感染者的各種醫療需求，包括初次接受治療的患者、長期接受治療但選擇有限的患者，以及因各種原因想要更換藥物的患者。

Since 2001, Gilead therapies have played a transformative role in changing HIV infection from a fatal and debilitating disease into a chronic and manageable condition. That is true around the world, as broader access to HIV treatment has helped divert millions of AIDS deaths.

自 2001 年以來，吉利德的療法在將 HIV 感染從一種致命且使人衰弱的疾病轉變為慢性且可控的疾病方面發揮了變革性作用。這種情況在世界各地都存在，因為更廣泛地獲得愛滋病治療幫助減少了數百萬愛滋病死亡病例。

Innovation remains important in the continuing fight against HIV, and we're proud that Descovy is the first new backbone approved by the FDA in more than a decade. Gilead continues the commitment to helping HIV patients around the globe with our research and development activities, including novel agents for daily treatment, long-acting regimens, and HIV care.

在持續對抗愛滋病毒的鬥爭中，創新仍然至關重要，我們很自豪 Descovy 是十多年來 FDA 批准的首個新型骨幹藥物。吉利德將繼續致力於透過我們的研發活動，包括用於日常治療的新藥、長效療法和愛滋病護理，幫助全球的愛滋病患者。

In liver disease, we just wrapped up an exciting week in Barcelona at the International Liver Conference (sic - Congress), or EASL, as it's known. It was a remarkable meeting, especially considering the significant change in HCV treatment landscape since the conference was held last in Spain four years ago.

在肝病領域，我們剛剛在巴塞隆納結束了激動人心的一周，參加了國際肝病大會（原文如此，應為「國際肝病大會」），也就是人們熟知的EASL大會。這是一次意義非凡的會議，尤其考慮到自四年前在西班牙舉行上一次會議以來，丙型肝炎治療領域發生了重大變化。

The outlook for patients has completely changed, with dramatic improvements in cure rates for a wider range of patients. Presentations at EASL included results from several Phase 2 and Phase 3 studies evaluating sofosbuvir, velpatasvir, and sofosbuvir/velpatasvir plus GS-9857. These are two investigational pangenotypic, fixed-dose combination therapies for the treatment of HCV. The data presented continued to underscore the high cure rates and safety of our sofosbuvir-based therapies and support their utility across all HCV patient genotypes in a wide range of disease stages.

患者的前景已經徹底改變，更多患者的治癒率得到了顯著提高。EASL 會議上的報告包括幾項 2 期和 3 期研究的結果，這些研究評估了索非布韋、維帕他韋以及索非布韋/維帕他韋加 GS-9857。這是兩種用於治療C型肝炎的在研泛基因型固定劑量組合療法。所呈現的數據繼續強調了我們基於索非布韋的療法的高治癒率和安全性，並支持其在所有 HCV 患者基因型和各種疾病階段的有效性。

Data were also presented on the use of TAF for patients with chronic hepatitis B infection. 48-week results from two Phase 3 studies demonstrated its potential to advance the treatment of HPV, offering a similar efficacy profile to Viread, with improved bone and renal safety parameters.

也介紹了 TAF 在慢性B型肝炎感染患者中的應用數據。兩項 3 期研究的 48 週結果表明，該藥物有潛力推進 HPV 的治療，其療效與 Viread 相似，且骨骼和腎臟安全性指標有所改善。

Based on these results, we submitted a new drug application for TAF, and FDA has set a PDUFA date of November 11. We also submitted regulatory applications for TAF in the European Union and Japan last quarter.

根據這些結果，我們提交了 TAF 的新藥申請，FDA 已將 PDUFA 日期定為 11 月 11 日。上個季度，我們也向歐盟和日本提交了TAF的監管申請。

I'm particularly encouraged by the work that's going on in NASH, which we've augmented with our agreement to acquire the Nimbus Acetyl-CoA Carboxlyase or ACC program, as was announced last month.

我尤其對 NASH 領域正在進行的工作感到鼓舞，我們透過收購 Nimbus Acetyl-CoA Carboxlyase 或 ACC 項目加強了這項工作，正如上個月宣布的那樣。

NASH affects up to 15 million people in the US and is expected to become the leading indication for liver transplantation by 2020. Including the ACC program, Gilead has four investigational compounds that target unique disease pathways, including production of lipids, inflammation, and fibrosis -- each of which are thought to contribute or cause NASH.

美國有多達 1500 萬人患有 NASH，預計到 2020 年，NASH 將成為肝臟移植的主要適應症。吉利德公司包括 ACC 計畫在內，目前有四種在研化合物針對獨特的疾病通路，包括脂質生成、發炎和纖維化——這些通路都被認為與 NASH 的發生或發展有關。

Data at EASL were presented supporting the development of Gilead's investigational agents for the treatment of NASH, including simtuzumab, a monoclonal antibody that is selective for LOXL2, which is also being evaluated in primary sclerosing cholangitis; GS-4997, an ASK-1 inhibitor; and GS-9674, an FXR agonist. Nimbus also presented positive Phase 1 data for the program's lead candidate, NDI-010976, which targets ACC, the key step in lipid biosynthesis pathway.

EASL 上發表的數據支持吉利德公司用於治療 NASH 的研究藥物的開發，其中包括 simtuzumab（一種選擇性針對 LOXL2 的單株抗體，目前也在評估其在原發性硬化性膽管炎中的療效）、GS-4997（一種 ASK-1 抑制劑）和 GS-9674（一種 FXR 激動劑）。Nimbus 也公佈了該計畫的主要候選藥物 NDI-010976 的積極 1 期數據，該藥物靶向 ACC，即脂質生物合成途徑中的關鍵步驟。

Overall, I'm enthusiastic about the future of Gilead and excited to have the opportunity to help build on the Company's long history of success. Over the past few months, I've had conversations with external stakeholders and employees across all parts of our organization. It's gratifying to see the extent to which Gilead's products and commitment to access have uniquely changed the course of diseases for so many people throughout the world. We now have the opportunity to do so again in many new areas.

總的來說，我對吉利德的未來充滿熱情，並很高興有機會幫助公司在悠久的成功歷史基礎上再創輝煌。在過去的幾個月裡，我與外部利害關係人以及我們組織各部門的員工進行了交流。令人欣慰的是，吉利德的產品和對藥物可及性的承諾，以獨特的方式改變了世界各地眾多患者的疾病進程。現在我們有機會在許多新領域再次這樣做。

A few things stood out during those conversations. First, physicians and patients share the excitement that our medical and commercial teams have regarding Gilead's new treatment options for HCV and HIV, particularly the new TAF-based therapies. Access continues to improve for people with HCV around the world. And, in fact, we've treated close to 1 million patients with sofosbuvir-based regimens since Sovaldi was first approved in late 2013. That's a remarkable achievement in just over two years.

在這些談話中，有幾件事讓我印象深刻。首先，醫生和患者與我們的醫療和商業團隊一樣，對吉利德針對 HCV 和 HIV 的新治療方案感到興奮，尤其是基於 TAF 的新療法。全球丙型肝炎患者的醫療服務水準持續提高。事實上，自 Sovaldi 在 2013 年底首次獲批以來，我們已經用索非布韋療法治療了近 100 萬名患者。短短兩年多就取得如此驚人的成就。

With regards to HIV, as many of you are aware, TAF was added to the medicines patent pool and to our various access programs. The clinical data suggests TAF-based regimens may be the best option in both the developed and developing world. We will build on the success we've had with the TDF-based regimens, now used by nearly 10 million people every single day, to make TAF regimens successful around the world, providing much-needed new options.

關於 HIV，正如你們許多人所知，TAF 已被納入藥品專利池和我們的各種獲取計劃。臨床數據表明，基於 TAF 的治療方案可能是已開發國家和發展中國家的最佳選擇。我們將以TDF療法取得的成功為基礎（目前每天有近1000萬人使用該療法），使TAF療法在世界各地取得成功，提供急需的新選擇。

Secondly, I believe we have a rich pipeline, creating opportunities that may allow the transformation of the treatment of many diseases, like NASH, HPV, inflammatory diseases, certain cancers, and cardiovascular conditions for which few, if any, options exist. We are committed to building on our Company's long history of success, and I am confident that our innovation and hard work will deliver on our shared goal of delivering new treatments and providing broad access to Gilead's medicines for patients in need.

其次，我相信我們擁有豐富的研發管線，這創造了可能改變許多疾病治療方式的機會，例如 NASH、HPV、發炎性疾病、某些癌症和心血管疾病，而對於這些疾病，幾乎沒有或根本沒有治療選擇。我們致力於在公司悠久的成功歷史基礎上再創佳績，我相信，我們的創新和努力將實現我們的共同目標，即為有需要的患者提供新的治療方法，並讓他們廣泛獲得吉利德的藥物。

Finally, we continue to look for business development opportunities that add to our core therapeutic areas and are a fit with Gilead's expertise and capabilities. We are actively assessing options and will make moves when the right opportunities present themselves.

最後，我們將繼續尋找能夠擴大我們核心治療領域並與吉利德的專業知識和能力相契合的業務發展機會。我們正在積極評估各種方案，一旦出現合適的機會，我們將採取行動。

I will now turn the call over to Robin, who will provide an overview of our financial results for the quarter. Robin will be followed by Paul, who will provide additional color on the Company's performance across products and geographies.

現在我將把電話交給羅賓，她將概述我們本季的財務表現。羅賓之後將由保羅發言，他將進一步介紹公司在產品和地理上的表現。

Thanks, John, and good afternoon, everyone. We are pleased to report our first-quarter results, with non-GAAP diluted earnings per share of $3.03 per share compared to $2.94 for the same period last year. Total revenues for the quarter was $7.8 billion, up 3% year-over-year and down 8% percent sequentially. Product sales for the quarter were $7.7 billion, up 4% year-over-year and down 9% sequentially.

謝謝你，約翰，大家下午好。我們很高興地報告第一季業績，非GAAP稀釋後每股收益為3.03美元，而去年同期為2.94美元。本季總營收為 78 億美元，年增 3%，季減 8%。本季產品銷售額為 77 億美元，年增 4%，季減 9%。

Starting with HIV and other antivirals: product sales for the first quarter increased to $2.9 billion, up 19% year-over-year, primarily driven by increased sales in the US. We continue to see strong uptake of our newer single-tablet regimens, including Genvoya, which was launched in November 2015.

先從 HIV 和其他抗病毒藥物說起：第一季產品銷售額增至 29 億美元，年增 19%，主要得益於美國銷售額的成長。我們持續看到我們新的單片療法受到熱烈歡迎，包括於 2015 年 11 月推出的 Genvoya。

Additionally, year-over-year, Stribild and Complera grew 34% and 19%, respectively. Sequentially, these sales decreased 4%, primarily driven by sub-wholesaler inventory decreases in the US, reflective of the seasonal inventory pattern from quarter four to quarter one.

此外，Stribild 和 Complera 的年增長率分別為 34% 和 19%。與上一季相比，這些銷售額下降了 4%，主要原因是美國二級批發商庫存減少，反映了從第四季到第一季的季節性庫存模式。

HCV product sales for the first quarter decreased 6% year-over-year to $4.3 billion, primarily driven by a decrease in Harvoni sales the US, which was partially offset by the launch of our HCV products in Japan and other international markets. In the US, the year-over-year Harvoni sales decline was driven by lower patient starts and the full-quarter impact of higher commercial rebates, which were entered into during the first quarter of 2015.

第一季 HCV 產品銷售額年減 6% 至 43 億美元，主要原因是 Harvoni 在美國的銷售額下降，但部分被我們在日本和其他國際市場推出的 HCV 產品所抵銷。在美國，Harvoni 銷售額同比下降的原因是患者數量減少以及 2015 年第一季簽訂的更高商業回扣對整個季度的影響。

Sequentially, HCV product sales decreased 12%, primarily driven by revenue declines in the US and Japan. In the US, the decline was due to the increase in discounts required to open up access to patients with lower fibrosis scores and a modest shift in payor mix toward more deeply discounted government payor segments.

丙肝產品銷售額較上季下降 12%，主要原因是美國和日本的收入下降。在美國，下降的原因是為使纖維化評分較低的患者也能獲得醫療服務而需要增加折扣，以及支付方結構略微轉向折扣力度更大的政府支付方。

In addition, revenue was further impacted by higher-than-expected prior-quarter rebate claims. Rebate claims come in one to two quarters in arrears and were updated in Q1 to reflect the higher claims received.

此外，由於上一季退款申請高於預期，收入也進一步受到影響。退款申請通常會落後一到兩個季度，並且在第一季進行了更新，以反映收到的較高申請量。

In Japan, Sovaldi volumes declined from high early launch levels, similar to other markets. And channel inventory pricing for Sovaldi and Harvoni was adjusted during March for the mandatory price reduction effected as of April 1.

在日本，Sovaldi 的銷售量從上市初期的高水準有所下降，與其他市場的情況類似。3 月份，Sovaldi 和 Harvoni 的通路庫存價格進行了調整，以適應 4 月 1 日起強制實施的降價。

Turning to our other therapeutic areas, product sales of cardiovascular, respiratory, and other were $498 million, up 19% year-over-year and down 5% sequentially. Moving to gross margin, non-GAAP product gross margin was 87.2% for the first quarter of 2016 compared to 90.9% for the same period last year. The decrease reflects a $200 million charge or $0.12 earnings per share related to the jury verdict in the Merck trial in March. Although the proceedings of the Merck trial are not complete, and the losing party will appeal once the court enters judgment, we booked the charge to comply with accounting rules related to contingencies.

再來看我們的其他治療領域，心血管、呼吸系統和其他領域的產品銷售額為 4.98 億美元，較去年同期成長 19%，較上季下降 5%。從毛利率來看，2016 年第一季非 GAAP 產品毛利率為 87.2%，去年同期為 90.9%。這一降幅反映了與 3 月默克案陪審團裁決相關的 2 億美元支出，即每股收益減少 0.12 美元。儘管默克案的審理程序尚未完成，敗訴方將在法院作出判決後提起上訴，但我們仍記入了這筆費用，以遵守與或有事項相關的會計規則。

Now, turning to expenses, non-GAAP R&D expenses were $769 million for the first quarter, up 18% compared to the same period last year due to the continued progression of clinical studies, particularly in liver disease and HIV. Non-GAAP SG&A expenses were $638 million for the first quarter, up 6% compared to the same period last year. These expenses increased primarily due to higher costs to support the growth of Gilead's business and were offset by favorable adjustments related to the branded prescription drug fee of $191 million following the receipt of the preliminary 2016 IRS invoice.

現在來看費用，第一季非GAAP研發費用為7.69億美元，比去年同期成長18%，主要得益於臨床研究的持續進展，尤其是在肝病和愛滋病毒領域。第一季非GAAP銷售、管理及行政費用為6.38億美元，較去年同期成長6%。這些支出增加主要是由於支持吉利德業務成長的成本增加，但因收到 2016 年美國國稅局初步發票後品牌處方藥費用 1.91 億美元的有利調整而抵消。

From a balance sheet perspective, during the first quarter we generated cash flows from operations of $3.9 billion and ended the quarter with $21.3 billion in cash and investments. We continue to return capital to our shareholders through dividends and opportunistic share repurchases. Earlier this afternoon, we announced that our Board of Directors declared a dividend of $0.47 per share for the second quarter of 2016, an increase of 10% from the prior quarter.

從資產負債表的角度來看，第一季我們透過經營活動產生了 39 億美元的現金流，季末我們擁有 213 億美元的現金和投資。我們將繼續透過分紅和擇機回購股票的方式向股東返還資本。今天下午早些時候，我們宣布董事會批准派發 2016 年第二季每股 0.47 美元的股息，比上一季成長 10%。

$8 billion in cash was utilized to repurchase shares of our common stock during the quarter, consisting of $3 billion of open-market repurchases or 33.4 million shares and $5 billion under the accelerated share repurchase program, ASR, that we announced in February. 46.1 million shares were repurchased under this program during the quarter.

本季我們動用了 80 億美元現金回購普通股，其中包括 30 億美元的公開市場回購（即 3,340 萬股）和 50 億美元的加速股票回購計畫 (ASR)，該計畫是我們於 2 月宣布的。本季度，根據該計劃回購了 4,610 萬股股票。

The final settlement of the ASR program was completed earlier this month, and we received an additional 8.1 million shares. In total, 54.3 million shares were retired under the ASR program at an average price of $92.09 per share.

ASR計畫的最終結算已於本月初完成，我們額外獲得了810萬股。根據 ASR 計劃，總共註銷了 5,430 萬股股票，平均每股價格為 92.09 美元。

As of March 31, the amount of capital returned to shareholders, consisting of dividends and share repurchases, exceeded the total amount of capital returned during the first three quarters of 2015 combined. During the quarter we completed a $15 billion share repurchase program approved by our Board in January 2015 and as of April 1 have begun repurchasing shares under our $12 billion 2016 share repurchase program approved in January of this year. Since 2012, we've repurchased over 260 million shares or 17% of shares outstanding.

截至 3 月 31 日，返還給股東的資本金額（包括股利和股票回購）超過了 2015 年前三個季度返還資本總額的總和。本季我們完成了董事會於 2015 年 1 月批准的 150 億美元股票回購計劃，並且從 4 月 1 日起，我們已開始根據今年 1 月批准的 2016 年 120 億美元股票回購計劃回購股票。自 2012 年以來，我們已回購超過 2.6 億股，佔流通股的 17%。

Finally, we are reiterating our full-year 2016 guidance provided to you on February 2 and summarized on slide 25 in the earnings results presentation available on our corporate website. As a reminder, guidance for product sales is subject to a number of uncertainties, including an uncertain global macroeconomic environment; adoption of additional pricing measures to reduce HCV spending; volatility in foreign currency exchange rates; an atrophy in HCV patient start estimates; additional competitive launches in HCV; an increase in discounts, chargebacks, and rebates due to ongoing contracts and future negotiations with commercial and government payors; and a larger-than-anticipated shift in payor mix to more highly-discounted payor segments, such as PHF, FFS, Medicaid and the VA.

最後，我們重申我們在 2 月 2 日向您提供的 2016 年全年業績指引，該指引已總結在我們公司網站上提供的盈利結果演示文稿的第 25 頁。提醒各位，產品銷售指導受多種不確定因素影響，包括全球宏觀經濟環境的不確定性；為降低丙型肝炎支出而採取的額外定價措施；外匯匯率的波動；丙型肝炎患者起始人數估計的減少；丙型肝炎領域其他競爭對手的推出；由於與商業和政府支付方的現有合同和未來談判，折扣、退款和回扣的增加；

I will now turn the call over to Paul to provide more details on our commercial results for the quarter.

現在我將把電話交給保羅，讓他詳細介紹我們本季的商業表現。

Thanks, Robin, and good afternoon, everyone. Our commercial performance remained strong through the first quarter. I'd like to start with HIV and Genvoya, the first of our TAF-based single-tablet regimens.

謝謝羅賓，大家下午好。第一季我們的商業業績依然強勁。我想先談談 HIV 和 Genvoya，這是我們基於 TAF 的首個單片療法。

We are pleased with the launch of Genvoya both in the US and European markets, where we've achieved reimbursement. Starting with the US, through five months post the launch of Genvoya, cumulative prescriptions were twofold more than any HIV product from any company since Atripla, which was the first single-tablet regimen to come to market back in 2006.

我們很高興 Genvoya 在美國和歐洲市場成功上市，並已獲得健保報銷。從美國開始，在 Genvoya 上市後的五個月內，累積處方量是自 Atripla 以來任何公司任何 HIV 產品的兩倍，Atripla 是 2006 年上市的首個單片療法。

As expected, most of Genvoya's initial prescriptions came from switches. Qualitative feedback from HIV prescribers is very encouraging and indicating a clear intent to switch patients at the earliest opportunity.

正如預期的那樣，Genvoya 的最初處方大多來自交換器。來自 HIV 處方醫生的定性回饋非常令人鼓舞，顯示他們有明確的意願儘早為患者更換藥物。

Stribild and Complera showed strong year-over-year prescription growth at 18% and 5%, respectively. And in quarter four 2015, Stribild was the leading product in the US for patients naive to treatment.

Stribild 和 Complera 的處方量分別年增 18% 和 5%，表現強勁。2015 年第四季度，Stribild 成為美國未接受過治療的患者中領先的產品。

With the launches of Genvoya and now, just very recently, Odefsey, we expect switches out of TDF-based single-tablet regimens into the TAF regimens to grow significantly. In fact, 82% of Genvoya's prescriptions have been switches. 49% of the switches have come from Stribild.

隨著 Genvoya 的上市，以及最近 Odefsey 的上市，我們預計從基於 TDF 的單片療法轉向 TAF 療法的人數將顯著增長。事實上，Genvoya 82% 的處方都是轉換處方。49% 的交換器來自 Stribild。

We are seeing an improvement in our ability to retain switch patients, meaning fewer patients who switch from Gilead TDF-containing regimens move to non-Gilead products. Of all the patients who switched to Genvoya, 91% came from a Gilead regimen and 9% came from a non-Gilead product. In addition to switches, preliminary quarter-one 2016 data indicate to us that Genvoya may soon be among the most prescribed products of patients new to treatment.

我們看到，我們在留住轉換治療患者方面的能力有所提高，這意味著從含吉利德 TDF 的治療方案轉換到非吉利德產品的患者人數減少了。在所有改用 Genvoya 的患者中，91% 來自吉利德的治療方案，9% 來自非吉利德的產品。除了轉換之外，2016 年第一季的初步數據顯示，Genvoya 可能很快就會成為新接受治療的患者最常開處方的產品之一。

Historically in quarter one, we've seen a decrease sub-wholesaler inventories following a buildup in the prior quarter. We observed this effect again this year, leading to a sequential decrease in HIV product sales.

從歷史數據來看，第一季度，在前一季度庫存增加之後，二級批發商的庫存通常會減少。今年我們再次觀察到這種現象，導致愛滋病產品銷售持續下降。

Finally, in the US, I'd like to highlight the growing use of Truvada for PrEP, which was more than 20% of Truvada demand last quarter and drove a 17% year-on-year growth in prescriptions.

最後，我想重點介紹美國 Truvada 在 PrEP 中的使用情況，上個季度 Truvada 的需求量超過 20%，處方量年增 17%。

Turning to Europe, we're also pleased with the way that our HIV business is performing, with successful reimbursement and launches of Genvoya in several countries, including Germany and the Nordics. In other countries, Stribild and Eviplera continue to replace Atripla. Stribild remains the most prescribed regimen for patients naive to treatment in the EU, with Eviplera in the third place.

再來看歐洲，我們對 HIV 業務的表現也感到滿意，Genvoya 在包括德國和北歐國家在內的多個國家成功獲得報銷並上市。在其他國家，Stribild 和 Eviplera 繼續取代 Atripla。在歐盟，Stribild 仍然是初次接受治療的患者最常使用的治療方案，Eviplera 則排名第三。

Genvoya was launched in Germany during quarter one, and at the end of the quarter preliminary data indicate that it had the leading market share for both naive and switch patients. The product was launched and fully reimbursed in Spain just two weeks ago, and we are very excited about the opportunity to offer providers another important option to address the needs of their patients.

Genvoya 於第一季在德國上市，季度末的初步數據顯示，它在初治患者和轉診患者中均佔據了領先的市場份額。該產品兩週前才在西班牙上市並獲得全額報銷，我們非常高興有機會為醫療服務提供者提供另一個重要的選擇，以滿足患者的需求。

It's also been recognized as a preferred regimen in numerous country guidelines, including Germany, Spain, and Italy -- even before reimbursement has been agreed. This is testament to the favorable clinical profile of Genvoya, a single-tablet regimen that better addresses the needs of patients who require long-term chronic therapy. We're working hard to negotiate timely reimbursements across the rest of the European markets.

它也被包括德國、西班牙和義大利在內的許多國家的指南認可為首選方案——甚至在報銷協議達成之前就已如此。這證明了 Genvoya 具有良好的臨床療效，它是一種單片給藥方案，能更好地滿足需要長期慢性治療的患者的需求。我們正在努力與歐洲其他市場協商及時報銷事宜。

Finally in HIV, we launched Descovy this month in the US and the EU. We see this launch as a milestone in HIV treatment, as Descovy is the first new NRTI backbone since Truvada 10 years ago. Given the very high use of Truvada as a preferred backbone with third -- multiple third agents, including Tivicay, we are confident that Descovy will quickly replaced Truvada and become the leading HIV regimen backbone in all our markets.

最後，在 HIV 領域，我們本月在美國和歐盟推出了 Descovy。我們認為此次上市是 HIV 治療領域的里程碑，因為 Descovy 是自 10 年前 Truvada 以來第一個新的 NRTI 骨幹藥物。鑑於 Truvada 作為首選骨幹藥物與多種第三方藥物（包括 Tivicay）的廣泛使用，我們相信 Descovy 將迅速取代 Truvada，成為我們所有市場中領先的 HIV 治療骨幹藥物。

Now, moving to hepatitis C: we continue to see revenue dynamics around the world, which vary by country. As Robin noted, our overall HCV product revenue decreased 6% year-over-year and 12% sequentially. I'll now describe the different dynamics by geographic region.

現在，我們來談談C型肝炎：我們繼續看到世界各地的收入動態，這些動態因國家而異。正如 Robin 指出的那樣，我們的 HCV 產品總收入年減 6%，環比下降 12%。接下來我將按地理區域描述不同的動態。

Starting with the US market, we've seen an increase of new patients in the first quarter, offset by lower revenue per patient, due to several factors that include an increase in our gross to net adjustments as well as a shortening average duration of therapy. Total market patient starts increased around 10% over Q4 to an estimated 55,000 in Q1. This was primarily driven by the continued opening of access across payor segments to allow for the treatment of patients with lower fibrosis scores as well as an increase in treatment by the VA during the second half of the quarter as funding made its way to the various VA sites.

以美國市場為例，第一季新患者數量有所增加，但由於多種因素，包括毛利淨額調整增加以及平均治療時間縮短，每位患者的收入有所下降，從而抵消了新患者數量的增長。第一季市場患者總數較第四季成長約 10%，估計達 55,000 例。這主要是由於支付方不斷開放准入，允許治療纖維化評分較低的患者，以及隨著資金撥付到各個退伍軍人事務部 (VA) 站點，VA 在本季度下半段增加了治療量。

The revenue associated with this increase in patient starts was partially offset by an increase in discounts associated with our contract agreement entered into during the first quarter of 2015, which provide for additional discounts if access is provided to a broader patient population. We also saw a gradual shift to more deeply discounted payor segments such as VA, PHF, and Medicaid compared to the prior quarter. In addition, revenue was further impacted by a higher-than-expected prior-quarter rebate claim, which come in one to two quarters in arrears and were updated in quarter one to reflect the higher claims received.

患者數量增加帶來的收入部分被 2015 年第一季簽訂的合約協議中規定的折扣增加所抵消，該協議規定，如果向更廣泛的患者群體提供服務，則可獲得額外折扣。與上一季相比，我們也看到，支付方群體（如退伍軍人事務部、PHF 和 Medicaid）的折扣力度逐漸增加。此外，由於上一季收到的退款申請高於預期，收入也受到了進一步影響。退款申請通常會滯後一到兩個季度，並在第一季進行了更新，以反映收到的較高申請。

The average duration of therapy has shortened as fewer patients require 24 weeks of treatment and a higher proportion of genotype one patients are treated for eight weeks, resulting in slightly lower revenues per patient. The ability to treat for eight weeks, notably, is a strong competitive differentiation. In fact, our market share remains strong, with more than 90% of all patients treated in the quarter being prescribed either Harvoni or Sovaldi.

由於需要接受 24 週治療的患者人數減少，而接受 8 週治療的基因型 1 患者比例增加，平均治療持續時間縮短，導致每位患者的收入略有下降。尤其值得一提的是，能夠進行長達八週的治療是一項強大的競爭優勢。事實上，我們的市佔率依然強勁，在本季度接受治療的所有患者中，超過 90% 的人都服用了 Harvoni 或 Sovaldi。

Qualitative feedback suggests that prescribing HCV physicians are encouraged by the fact that real-world outcomes mimic the experience in clinical trials. Several presentations of real-world data at EASL reinforce what has been seen in clinical practice.

定性回饋表明，開立丙型肝炎處方的醫生們受到鼓舞，因為現實世界的結果與臨床試驗中的經驗相似。EASL 上的幾個真實世界資料展示，印證了臨床實務中觀察到的情況。

As we think about the rest of the year in the US, patient flow peaked in quarter one 2015, then declined in quarter two and stabilized in quarter three and quarter four of 2015. In quarter one of 2016, there was an uptick in new patient starts.

展望美國今年的剩餘時間，患者流量在 2015 年第一季達到峰值，然後在第二季下降，並在 2015 年第三季和第四季趨於穩定。2016年第一季度，新患者數量增加。

Our data show that 25,000 to 30,000 patients a month are entering treater care, which exceeds the number of patients starting therapy on a monthly basis. That means there are many more people who could benefit from treatment who are already linked to care. We expect new patient starts to remain consistent through the rest of 2016.

我們的數據顯示，每月有 25,000 至 30,000 名患者進入治療階段，超過了每月開始接受治療的患者人數。這意味著還有更多已經接受治療並可能從治療中受益的人。我們預計2016年剩餘時間內新患者數量將保持穩定。

Despite the number of patients treated to date, there are still over 3 million patients in the US who have yet to be treated. About half of these patients are undiagnosed. Education and awareness efforts to increase rates of diagnosis are important, and as we well know from public health efforts in the HIV area, these efforts play out over many years. We are encouraged to see data that screening and diagnosis rates have increased at least twofold over the last five years.

儘管迄今為止已治療了相當數量的患者，但美國仍有超過 300 萬名患者尚未接受治療。這些患者中約有一半未被確診。提高診斷率的教育和宣傳工作非常重要，正如我們在愛滋病毒領域的公共衛生工作中所了解的那樣，這些工作需要很多年才能完成。我們很欣喜地看到，數據顯示，過去五年篩檢和診斷率至少翻了一番。

Now turning to Europe: total HCV revenue in Europe was down 13% year over year and down 1% sequentially, while overall Gilead patient starts with increased 5% sequentially to around 31,000 in the quarter. Average revenue per patient declined due to a shift in geographic mix and shorter average treatment duration. We also saw a negative foreign exchange movement, which affected HCV revenues by about 8% year on year and 3% sequentially.

現在來看歐洲：歐洲的 HCV 總收入年減 13%，較上季下降 1%，而吉利德的整體患者起始治療量較上季增加 5%，本季達到約 31,000 例。由於地理組成變化和平均治療時間縮短，每位患者的平均收入下降。我們也觀察到外匯匯率的負面影響，導致HCV收入年減約8%，較上季下降約3%。

The mix of sales in the EU is such that more patients are now being treated in countries which have lower net prices per patient. European countries continue to vary significantly in terms of patient access, with many still limiting treatment to patients with high fibrosis scores. We anticipate that as sicker are treated, these restrictions will start to loosen, as healthier patients can be cared for within existing budgets.

歐盟的銷售結構導致越來越多的患者在人均淨價格較低的國家接受治療。歐洲各國在患者就醫方面仍有顯著差異，許多國家仍將治療限制在纖維化評分較高的患者身上。我們預計，隨著病情更嚴重的患者得到治療，這些限制將會開始放鬆，因為在現有預算內也能照顧到病情較輕的患者。

Again, as in the US, we treat just a small fraction of patients diagnosed. We are encouraged by ongoing efforts and commitments by governments to increase diagnosis and treatments across Europe.

同樣，和美國的情況一樣，我們只能治療確診患者的一小部分。歐洲各國政府為提高診斷和治療水準所做的持續努力和承諾令我們倍感鼓舞。

Now, moving to Japan, revenue was over $1 billion during the quarter. We are pleased with the successful launches of Sovaldi and Harvoni, where a strong patient flow and high market shares continue through quarter one. More than 30,000 patients were treated with Gilead products during the quarter, representing a market share greater than 90%.

現在來看日本市場，該季度營收超過10億美元。我們對 Sovaldi 和 Harvoni 的成功上市感到滿意，在第一季度，這兩款藥物的患者流量和市場份額都保持強勁增長。本季有超過 30,000 名患者接受了吉利德產品的治療，市佔率超過 90%。

Other markets where we recently launched our HCV products include Australia, where nearly 5,000 patients started treatment in Q1. This reflects a strong commitment by the Australian government to address their HCV burden and the usual warehousing of patients prior to the launch of sofosbuvir-based regimens.

我們最近推出 HCV 產品的其他市場包括澳大利亞，第一季有近 5,000 名患者開始接受治療。這反映了澳洲政府致力於解決其丙型肝炎負擔的堅定決心，以及在推出索非布韋療法之前對患者進行常規隔離的做法。

In closing, our underlying HCV business is strong and sustainable. We've treated around 700,000 patients in the US, Europe, and Japan. And despite strong competition, Gilead has maintained a high market shares in all regions.

總之，我們的基礎HCV業務強勁且永續發展。我們在美國、歐洲和日本治療了約70萬名患者。儘管競爭激烈，吉利德在所有地區都保持了較高的市場份額。

The Gilead commercial organization is focused on executing our numerous HIV and HCV product launches across multiple geographies during the remainder of the year. In addition to our three TAF-based HIV products, we are preparing to launch our pan-genotypic HCV product as early as next quarter in the US.

吉利德商業組織將在今年剩餘的時間裡，在多個地區執行我們眾多 HIV 和 HCV 產品的上市計畫。除了我們現有的三款基於 TAF 的 HIV 產品外，我們正準備最早於下個季度在美國推出我們的泛基因型 HCV 產品。

Thank you. And now let's open the call for questions. Operator?

謝謝。現在開始接受提問。操作員？

(Operator Instructions) Geoff Meacham, Barclays.

（操作說明）Geoff Meacham，巴克萊銀行。

Seems like lower revenue per patient was one of the bigger contributors to the sequential trends. So a couple of questions: what was the initial outlook for higher volumes coming from commercial patients, just with respect to broader access for F0 and F1?

似乎每位患者收入下降是導致這一連續趨勢的主要因素之一。所以，我有幾個問題：就 F0 和 F1 的更廣泛准入而言，來自商業患者的更高數量的最初前景如何？

And then was the volume contribution this quarter pretty meaningful from the VA system? I just want to get a sense for the sequential trends there, too. Thanks.

那麼，本季退伍軍人事務部系統的業務量貢獻是否相當顯著？我也想了解那裡的發展趨勢。謝謝。

So, yes -- so several things happened in the quarter in relation to volume and revenue per patient. So maybe I'll try and deal with all of them.

是的，本季在患者數量和每位患者的收入方面發生了一些變化。所以也許我會試著處理所有這些問題。

So the first thing, as you said, we had -- and we expected this, and hoped for it -- that several of the large commercial payors opened up access to patients, regardless of their fibrosis scores, during quarter one. The consequence of that was that they triggered a discount that had been previously negotiated in order to incentivize that opening up of restrictions. So that was the first thing.

正如你所說，我們首先看到的是——而且我們也預料到了，並且希望如此——幾家大型商業支付方在第一季度向患者開放了就醫渠道，無論他們的纖維化評分如何。結果是，他們觸發了先前為了激勵放寬限製而協商達成的折扣。這是第一件事。

And then the VA, as you know, treated very few patients in quarter four last year because of lack of funding. That funding was agreed for a two-year period and focused on HCV medicines and was clarified late December. Then the VA went through a process of evaluating the clinical evaluation of product available from not just us, but obviously new entrants to the market. And that process took through till mid-to-late January.

如您所知，由於資金不足，退伍軍人事務部去年第四季收治的病人非常少。該資金的期限為兩年，重點用於丙型肝炎藥物，並在 12 月下旬得到了明確。然後，退伍軍人事務部對市場上提供的產品進行了臨床評估，這些產品不僅來自我們，顯然也來自市場上的新進者。這個過程一直持續到一月中下旬。

And we had to negotiate with the VA, and we did give the VA some extra discount, which resulted in them putting our products on their formulary and also opening up again access to all patients within the VA. So there are no restrictions on patients. And again, we see this as a large positive.

我們必須與退伍軍人事務部進行談判，我們確實給了退伍軍人事務部一些額外的折扣，結果他們把我們的產品納入了他們的處方集，也重新向退伍軍人事務部的所有患者開放了獲取途徑。所以對病人沒有任何限制。我們再次認為這是一個很大的正面因素。

And as those funding got distributed around VA centers, we started to see a very large uptick in VA treatment from about the middle of the quarter. And we anticipate that that will continue through the year.

隨著這些資金分配到各個退伍軍人事務部中心，從季度中期開始，我們看到退伍軍人事務部治療量大幅上升。我們預計這種情況將持續到年底。

The second kind of area that happened, of course, is we had the entrance of Merck into the market. And so we judiciously exercised our contractual right to preserve access. And in a few cases, we did increase a little bit of discount to some payors to ensure that Harvoni in particular remained on formularies and with full access.

當然，第二種情況是默克公司進入市場。因此，我們審慎地行使了合約賦予我們的權利，以保留存取權限。在少數情況下，我們確實提高了對某些付款人的折扣，以確保 Harvoni 尤其能夠繼續留在處方集內並獲得完全的訪問權限。

The third thing I think we've seen, as I indicated in the comments, was a slight and gradual shift of payor mix away from the commercial and Medicare Part D payors towards the more government payors. And that was probably about a 10% shift from quarter four to quarter one.

正如我在評論中指出的那樣，我認為我們看到的第三件事是，支付方組成逐漸從商業保險和聯邦醫療保險D部分支付方轉向政府支付方。這大概相當於從第四季到第一季變化了10%。

And then the final piece, as we indicated, is we did have a catch-up, a true-up of some rebate claims that came in respect to quarter three and quarter four that were a little bit higher than we estimated last quarter, and which we put right during quarter one. So that really is the dynamic between volumes and revenue per patient.

最後一點，正如我們之前提到的，我們確實對第三季度和第四季度的一些退款申請進行了補正，這些申請比我們上個季度估計的要高一些，我們在第一季度進行了糾正。這就是就診量和每位病患收入之間的動態關係。

Okay. Thanks a lot, Paul.

好的。非常感謝，保羅。

Mark Schoenebaum, Evercore ISI.

Mark Schoenebaum，Evercore ISI。

By the way, John, I really enjoyed your opening comments. Everyone's very focused on what you're going to do with your cash, BD, M&A. So I have, actually, one simple question, probably for John: would you be willing to go hostile? And if not, why not? How do you feel about that? Because clearly, what we're hearing is that the small companies won't engage right now because they don't like the valuations, but the large companies are very interested. Thank you.

對了，約翰，我非常喜歡你的開場白。大家都非常重視你打算如何運用你的資金、業務拓展和併購。所以，我其實有一個簡單的問題，可能是問約翰的：你願意採取敵對行動嗎？如果不是，為什麼不是？你對此有何感想？很明顯，我們聽到的消息是，小公司現在不願意參與，因為他們不喜歡目前的估值，但大公司卻非常感興趣。謝謝。

Hi, Mark. It's John. You know, mergers and acquisitions are always a process. And so the ability to go hostile is limited by how much data or how much corporation you need. So in each situation, you'd have to kind of think about -- what do I need to know about the pipeline, or about things that are not public about a company in order to be comfortable making sort of a public offer for the company?

嗨，馬克。是約翰。你知道，併購始終是一個過程。因此，採取敵對行動的能力取決於你需要多少數據或多少資源。因此，在每種情況下，你都需要思考——為了能夠放心地對該公司提出公開收購要約，我需要了解哪些關於管道的信息，或者了解哪些關於公司不公開的信息？

But that being said, we've never declared ourselves unwilling to go hostile. I do prefer a friendly process, but it would just depend on the situation itself.

但即便如此，我們也從未公開表示不願採取敵對行動。我確實更傾向於友好協商的過程，但這也要視具體情況而定。

Thank you very much.

非常感謝。

Geoffrey Porges, Leerink Partners.

Geoffrey Porges，Leerink Partners。

John, welcome to -- leading your first call completely. I guess follow-up on that question: you've invested, it looks like, about $19 billion or $20 billion over the last year. Now producing your share count, and the share count has come down by about 10%; but your EPS is pretty much flat, maybe up low single digits versus last year.

約翰，歡迎來到——完全主導你的第一次通話。我想就這個問題再補充一點：看起來你們在過去一年投資了大約 190 億美元或 200 億美元。現在計算您的股份數量，股份數量下降了約 10%；但您的每股收益基本上持平，可能比去年略有增長。

Are you convinced that that's the best use of your capital? You've got $21 billion in cash and about the same amount of debt. So are you going to revisit that? Or is that more or less the path that you believe generates the best returns here?

你確信這是你資金的最佳用途嗎？你有210億美元的現金，但債務也差不多有這麼多。所以你打算重新考慮這個問題嗎？或者說，你認為這條路或多或少能帶來最佳回報？

Geoff, I think that was directed to me, but I'm going to let Robin answer the first part of that question.

傑夫，我覺得那是問我的，但我還是讓羅賓來回答問題的第一部分吧。

Hi, Geoff. It's Robin. I think as we said all along, we've looked at how we leverage our cash as not only being share repurchases and dividends, but also we consistently look at investing in our core pipeline as well as M&A where appropriate. And similar to the amounts that you called out relative to cash, it's actually about 17% reduction in share count, as I mentioned on the call.

嗨，傑夫。是羅賓。我認為正如我們一直以來所說的那樣，我們一直在研究如何利用現金，不僅包括股票回購和分紅，而且我們還持續關注對核心產品線的投資以及在適當的時候進行併購。正如我在電話會議上提到的，與您提到的現金相關金額類似，這實際上相當於股份數量減少了約 17%。

We have done a lot of M&A as well, and I think we'll continue to do that, and as John said, when the right opportunities present themselves. So I think we've always been fairly clear that we are balancing doing all of those things. And we have purposely focused on share repurchases, because in the absence of M&A, it allows us to be flexible and more opportunistic. But when does the right M&A opportunities present themselves, it allows us to reduce our share repurchases in order to make those necessary acquisitions and leverage our cash and debt and borrowing if we need to.

我們也做了很多併購，我認為我們會繼續這樣做，正如約翰所說，當合適的時機出現時。所以我覺得我們一直都很清楚，我們正在努力平衡做好所有這些事情。我們特意專注於股票回購，因為在沒有併購的情況下，這使我們能夠更加靈活，更具機會主義精神。但是，當合適的併購機會出現時，我們可以減少股票回購，以便進行必要的收購，並在需要時利用我們的現金、債務和借款。

Yes, it's just -- for us it's fairly simple. We have the flexibility to do both things: that is, return shareholder value through stock repurchases and dividends and, of course, continue to be opportunistic in M&A. How we're deploying it is sort of a reflection of the things we're interested in -- I think, for example, the Nimbus acquisition, while relatively small, could bring a very, very unique product to us and something that we are focused on during the quarter. We're continuing to look for opportunities like that. And we will continue to aggressively look for opportunities to deploy our cash in investing in things other than Gilead.

是的，對我們來說就很簡單。我們有能力靈活地做這兩件事：即透過股票回購和分紅來回報股東價值，當然，我們也會繼續在併購方面抓住機會。我們部署的方式在某種程度上反映了我們感興趣的事物——例如，我認為，收購 Nimbus 雖然規模相對較小，但可能會為我們帶來非常非常獨特的產品，這也是我們本季的重點。我們將繼續尋找類似的機會。我們將繼續積極尋找機會，將我們的資金用於投資吉利德以外的其他項目。

Thanks. I'll the back in the queue.

謝謝。我重新排隊。

Michael Yee, RBC Capital Markets.

Michael Yee，加拿大皇家銀行資本市場。

I wanted to revisit some questions that was talked about related to price and volume. You did mention, on the positive, that net new patient starts were up about 10%, which is great. But then the total revenues in the US declined by 11%.

我想重新探討一些與價格和成交量相關的問題。您也提到了一個積極的方面，即新增患者人數淨增長了約 10%，這很​​好。但隨後美國的總收入卻下降了 11%。

So someone could do the math and imply that price was down 10% to 20%. Can you comment on that, or maybe just describe where you think the price/volume equation was in the quarter, and how we should think about net price changing quarter over quarter, and how that should change over the year? Thanks.

所以有人可以計算出價格下跌了 10% 到 20%。您能否就此發表一下看法，或描述一下您認為本季價格/銷售關係處於什麼位置，以及我們應該如何看待淨價格的季度環比變化，以及這種變化在一年中應該如何變化？謝謝。

Yes, Michael, I think we are in a much more stable place than we were one year ago at this time. I think I described it just now. We've made some contractual moves which have opened up access. We are very happy about that.

是的，邁克爾，我認為我們現在的處境比一年前這個時候穩定得多。我覺得我剛才已經描述過了。我們採取了一些合約方面的措施，從而打開了准入管道。我們對此感到非常高興。

We are happy that some of the government payors are beginning to treat a few people. We are very happy about the VA in particular ramping up its treatment levels. I said that, you know, we'd had to compete in the VA; and we did that, but we're enjoying very high market shares wherever physicians have the choice of prescribing. And that's always been our aim: to make sure that physicians and patients can choose what drug they think is appropriate. And wherever that's the case, Gilead seems to do pretty well.

我們很高興看到一些政府資助機構開始為部分患者提供治療。我們尤其對退伍軍人事務部提高治療水準感到非常高興。我說過，你知道，我們必須在退伍軍人事務部競爭；我們也做到了，但只要醫生可以選擇開處方，我們就享有非常高的市場份額。我們的目標始終是：確保醫生和患者能夠選擇他們認為合適的藥物。無論在什麼情況下，基列似乎都發展得相當不錯。

So I would say looking forward, we're in a fairly stable place now. Clearly over time, as competition increases, prices are likely to incrementally move in one direction, I would think. But I think we're stable.

所以我覺得展望未來，我們現在處境相當穩定。我認為，隨著時間的推移，競爭加劇，價格很可能會逐漸朝著一個方向發展。但我認為我們目前很穩定。

So on one side we're getting lots of access, but on the other side, my math is not totally off, just to be fair.

所以一方面我們獲得了大量的資源，但另一方面，公平地說，我的計算並非完全錯誤。

Correct.

正確的。

Okay, got it. Thank you, guys.

好的，明白了。謝謝大家。

Cory Kasimov, JPMorgan.

科里·卡西莫夫，摩根大通。

Going back to the strategic theme, you've talked in the past about wanting to be a leader in oncology. But given the issues you've had with Zydelig and the leadership changes you've also had, are you as committed to that space as you once were? And if so, what's your thought on the potential opportunities you see out there between solid tumors and hem/onc? Thanks.

回到策略主題，您過去曾談到希望成為腫瘤學領域的領導者。但考慮到你與 Zydelig 之間出現的問題以及領導層的更迭，你是否還像以前那樣對這個領域充滿熱情？如果是這樣的話，您認為實體腫瘤和血液/腫瘤之間有哪些潛在的機會？謝謝。

Corey, it's John. That's, of course, a big question. So if you think about where we are in our oncology portfolio, we have been focused heavily on a number of activities around these kinase inhibitors and have actually behind Zydelig a number of opportunities that are moving into clinic, including our SYK inhibitor, our BTK inhibitor. I should probably let Norbert go on about this, but I would say we have numerous opportunities that we're continuing to pursue.

科里，我是約翰。這當然是個大問題。所以，如果你想想我們在腫瘤產品組合中所處的位置，我們一直非常專注於圍繞這些激酶抑製劑的多項活動，並且實際上在 Zydelig 背後有許多正在進入臨床的機會，包括我們的 SYK 抑製劑和 BTK 抑製劑。我或許應該讓諾伯特繼續說下去，但我還是要說，我們有很多機會繼續追求。

You had mentioned we wanted to be a leader in oncology. We think of oncology as one leg of a future company that could be important to us, along with our investments in NASH and inflammatory diseases. We do see some good opportunities out there, and we see some good opportunities internally. So I don't -- the Zydelig setback hasn't changed our appetite for trying to do more transformative things in oncology.

您曾提到我們希望成為腫瘤學領域的領導者。我們認為腫瘤學是未來公司發展的重要組成部分，就像我們在 NASH 和發炎性疾病領域的投資一樣。我們看到了一些不錯的外部機會，也看到了一些不錯的內部機會。所以，我並不認為——Zydelig 的挫折改變了我們嘗試在腫瘤學領域進行更多變革的熱情。

It was never going to be a franchise product like Viread or sofosbuvir but was a good beginning for us. And I really haven't changed my thought process around it as a result of the setback because of the toxicities we've seen. Norbert, do want to add anything to that?

它注定不會成為像Viread或sofosbuvir那樣的特許經營產品，但對我們來說卻是一個好的開始。儘管遭遇了挫折，也看到了種種負面影響，但我並沒有因此改變我對這件事的看法。諾伯特，你還有什麼要補充的嗎？

No. As John said, Zydelig has not only not decreased our appetite; it has increased our appetite to do more in oncology. And you know, we are now at a point where a number of programs are coming to fruition -- for instance, momelotinib we're intending to file early next year. The Phase 3 studies are fully enrolled. We should get the results at the end of this year. The MMP9 antibody is in Phase 3 for gastric cancer. We are at the end of dose ranging with combinations of PI3K SYK and SYK BTK, and that will move into front-line treatment.

不。正如約翰所說，Zydelig 不僅沒有降低我們的求知欲，反而提高了我們在腫瘤學領域投入更多精力的慾望。你知道，我們現在正處於許多計畫即將取得成果的階段——例如，我們計劃在明年初提交 momelotinib 的申請。第三階段研究已全部招募完畢。我們應該會在今年年底得到結果。MMP9抗體目前正處於胃癌治療的第3期臨床試驗階段。我們已經完成了 PI3K SYK 和 SYK BTK 組合的劑量範圍研究，這將進入第一線治療階段。

So we have a number of interesting things ongoing internally. And, of course, as John said, we are continuously looking externally at finding suitable opportunities. And if the right opportunity comes along, then we will take advantage of it.

所以我們內部正在進行一些有趣的專案。當然，正如約翰所說，我們也一直在外部尋找合適的機會。如果合適的時機出現，我們一定會抓住它。

Great. Thank you.

偉大的。謝謝。

Brian Abrahams, Jefferies.

Brian Abrahams，傑富瑞集團。

I was wondering if you can talk a little bit about hep C diagnostic initiatives and maybe some of the pullthroughs that you're seeing or might expect to see on patient identification. And I'm particularly curious if you have a sense, among the growing number of new patients starts, who may have been identified last year and are now getting access with fewer restrictions versus patients who are getting identified this year and coming onto treat or care concurrently? Thanks.

我想請您談談丙肝診斷計劃，以及您在患者識別方面看到的或可能看到的一些進展。我特別想知道，在不斷增加的新患者中，哪些患者可能是去年確診的，現在獲得治療的限制較少，而哪些患者是今年確診的，並同時接受治療或護理？謝謝。

So it's actually very hard to tell when people are being diagnosed, and who is being treated when. Anecdotally, I can tell you -- I was out visiting some doctors in California just last week. Patients are -- there are plenty of patients there. There's many people who are linked to care now.

所以實際上很難判斷人們何時被確診，以及何時接受治療。就我個人經驗而言，我可以告訴你——就在上週，我去加州拜訪了一些醫生。那裡有很多病人。現在有很多人都與護理相關。

And with the fibrosis restrictions being dropped now, most physicians can treat -- certainly in the commercial area and Medicare area -- can treat whoever they want. One thing is clear, though, that there are still prior authorizations in place. And there's still a fair amount of office paperwork and bureaucracy that have to be put in place for each patient.

現在纖維化限制被取消了，大多數醫生——尤其是在商業領域和醫療保險領域——可以治療任何他們想治療的人。但有一點很明確，那就是目前仍需事先獲得授權。而且，每個病人仍然需要處理相當多的辦公文書工作和繁瑣的行政程序。

Then there's the patients themselves, many of whom just simply aren't quite mentally ready or psychologically ready to commit to their disciplined eight-week or 12-week treatment. And with these products, of course, insurance companies aren't keen to do it twice. You know, they want to try and get it right first time. The doctors want to get it right first time, and the patients want to get it right the first time.

此外，還有患者本身，他們中的許多人根本沒有做好心理準備，無法堅持進行為期八週或十二週的嚴格治療。當然，對於這類產品，保險公司並不願意做兩次。你知道，他們想力求第一次就把事情做好。醫生希望第一次就診斷正確，病人也希望第一次就治療正確。

So we're seeing that some of the sort of delays in patient starting are to do with the patient just being ready to commit to a sort of disciplined 8 or 12 weeks of patients.

所以我們看到，患者開始治療的某些延遲與患者尚未準備好投入8週或12週的嚴格治療有關。

On the diagnosis side, again anecdotally, we just know that there's a lot of activities going on. A lot of people are telling us what was going on around the countryside, and we do see diagnosis rates increasing significantly. So I think there are plenty of patients being diagnosed, and there are plenty of patients coming into treatment. And there's a waiting list of patients at most offices. By the way, our estimate on diagnosis is about 200,000 new diagnoses happened in the US last year.

在診斷方面，我們只是根據一些零星的例子知道，有許多活動正在進行中。很多人告訴我們農村地區的情況，我們也看到診斷率顯著上升。所以我認為有很多患者被確診，也有很多患者接受治療。大多數診所都有病人排隊等候。順便一提，據我們估計，去年美國新增確診病例約有 20 萬例。

Brian, I might want to add to that we have a number of demonstration projects ongoing in the United States to look for places, institutions, populations and figure out what the diagnosis positivity would be. And it's surprising; we've identified some places, like ER rooms, that have seropositivity rates of greater than 10%. We hope that those demonstration projects will then lead to a broader recognition of the value of diagnosis and identification of hepatitis C infected individuals.

布萊恩，我還要補充一點，我們目前在美國開展了一些示範項目，旨在尋找合適的地點、機構和人群，並確定診斷陽性率是多少。令人驚訝的是，我們發現有些地方，例如急診室，血清陽性率超過 10%。我們希望這些示範計畫能讓人們更廣泛地認識到診斷和識別丙型肝炎感染者的價值。

Thanks very much.

非常感謝。

Brian Skorney, Robert Baird.

布萊恩·斯科尼，羅伯特·貝爾德。

I guess two quick ones: I know we talked a little bit about this at EASL, John, but just refresh us on the timeline in terms of when you think you can get sofosbuvir-based regimens approved in China; how you think about pricing that there to kind of capture share of patients who are looking at a branded drug versus potentially penetrating further in.

我想問兩個簡單的問題：我知道我們在 EASL 上討論過這個問題，John，但請你再給我們更新一下你認為何時能在中國獲得基於索非布韋的治療方案的批准的時間表；以及你如何考慮在中國定價，以吸引那些正在考慮品牌藥的患者，並有可能進一步滲透市場。

And then just on the US, have you guys heard anything in terms of a warehouse build in genotype 3 ahead of a SOF/VEL launch? Should we be expecting a small bolus of patients upon that approval?

還有，就美國而言，你們有沒有聽說過在 SOF/VEL 推出之前，在基因型 3 中建造倉庫的消息？在該批准生效後，我們是否可以預期會有少量患者湧入？

Brian, I will start with the China question. So in terms of timing for China, there is a fairly fixed process. And according to the recent processes, we could possibly have sofosbuvir the market in 2017.

布萊恩，我先從中國問題談起。所以就中國的時間安排而言，有一個相當固定的流程。根據最近的進展，我們有可能在 2017 年看到索非布韋上市。

As you may have seen, there are new -- the Chinese government is working hard to try to accelerate review and approval of HCV drugs, because currently none are on the market of the direct-acting antivirals. And that could help us accelerate the timelines into China. We are working on that.

正如你可能已經看到的，中國政府正在努力加快對丙型肝炎藥物的審查和批准，因為目前市場上還沒有直接作用的抗病毒藥物。這有助於我們加快進軍中國的步伐。我們正在努力解決這個問題。

Particularly of interest to us would be accelerating the timeline for SOF/daclatasvir, because there's so many different genotypes in China. Genotyping is not common in China, and this could provide a very good option for the people of China.

我們特別感興趣的是加快 SOF/daclatasvir 的研發進度，因為中國有許多不同的基因型。基因分型在中國並不普遍，這可能為中國人民提供一個非常好的選擇。

So that would -- there's hope. But we can't guarantee, of course, that we could accelerate that approval beyond its current timeline, which is 2019.

所以——還有希望。當然，我們不能保證能夠將審批速度加快到目前的2019年之前。

The Chinese market is fairly large. Between 10 million and 20 million people are thought to have HCV. I don't want to get into public discussions of pricing, but I do think there's a price/volume relationship that would work for us and for the Chinese health system that could be very, very good for us both. And so that's what we're working towards is access in China.

中國市場相當龐大。據估計，全球有1000萬至2000萬人感染了C型肝炎病毒。我不想公開討論定價問題，但我認為存在一種價格/銷售關係，對我們和中國醫療體係都有利，這對我們雙方都非常有利。所以，我們努力的目標是獲得進入中國市場的機會。

Your second question was on warehousing for genotype 3 patients. Currently, a lot of genotype 3 patients are being treated with SOF in combination with the daclatasvir. And so that seems -- there seems to be fairly decent access for that.

你的第二個問題是關於基因型 3 患者的倉儲問題。目前，許多基因型 3 患者正在接受索非布韋合併達卡他韋治療。所以看來——似乎有相當不錯的途徑可以實現這一點。

So I'm looking at Paul. I don't think there's any real warehousing going on, but maybe you're more aware of it than I am?

所以我現在看著保羅。我認為並沒有真正的倉儲活動，但也許你比我更了解這方面的情況？

Well, you know there is -- about 7% or 8% of the US HCV epidemiology is genotype 3. We don't have any data on it, but certainly we get -- I'm getting the impression from my team anecdotally there is a little bit of warehousing. Not least because sofosbuvir/daclatasvir is obviously a very expensive regimen. And the hope is that the cost of genotype 3 treatment will come down somewhat after SOF/VEL comes onto the market, which -- the PDUFA date is June 28. So people are thinking about that. So we're optimistic.

你知道，美國C型肝炎病毒流行病學中約有 7% 或 8% 的病例是基因型 3。我們沒有任何相關數據，但肯定的是，我從我的團隊那裡得到一些非正式的回饋，感覺存在一些病例積壓的情況。尤其因為索非布韋/達克拉他韋顯然是一種非常昂貴的治療方案。人們希望在 SOF/VEL 上市後，基因 3 型治療的成本能夠下降，而 SOF/VEL 的 PDUFA 上市日期是 6 月 28 日。所以大家都在思考這個問題。所以我們持樂觀態度。

Great. Thanks, guys.

偉大的。謝謝各位。

Phil Nadeau, Cowen and Company.

Phil Nadeau，Cowen and Company。

A few questions on Japan. I know you said that there was some change in pricing because of the April 1 price declines during the quarter. What other dynamics were going on in Japan during this quarter? Where do you think you are [entering] the bolus in Japan? How much longer could that go?

關於日本的幾個問題。我知道您說過，由於本季 4 月 1 日的價格下跌，價格有所變化。本季日本還有哪些動態？你認為你在日本的哪個部位注射了胰島素？這種情況還能持續多久？

And then, separately, I believe that there were price discounts that come in with a certain volume being reached. Are we right to assume that those could be hit in July? And what kind of dynamics do you expect to see in the Japanese market going forward?

此外，我認為當訂單量達到一定水準時，還會有價格折扣。我們是否可以假設這些地區可能會在7月遭受攻擊？您預期日本市場未來將呈現怎樣的發展趨勢？

So we're very, very pleased with the execution of our launches in Japan. In terms of patient flow, the genotype 2 patients, which represent about 20% of the Japanese epidemiology in HCV, are beginning to stabilize now. So those are the patients being treated with Sovaldi.

所以我們對我們在日本的上市執行情況非常非常滿意。就患者流量而言，基因型 2 患者（約佔日本 HCV 流行病學的 20%）現在開始趨於穩定。這些就是正在接受索非布韋治療的患者。

Those numbers -- we launched on May 25 last year. We initially had a bolus, and then those numbers came down through quarter four. And quarter one is at a lower level than quarter four. But we are seeing a stable flow of patients now in genotype 2, and we would anticipate that to be stable through the rest of the year.

這些數據—我們於去年5月25日推出。我們最初投入了巨額資金，然後這些數字在第四季度開始下降。第一季水準低於第四季。但我們現在看到 2 型基因型患者數量穩定，我們預計這種情況在今年剩餘的時間裡將保持穩定。

Genotype 1 is treated by Harvoni. We've treated an enormous number of patients initially. We're not quite sure if the curve in Japan is identical to the sort of curves we've seen in the US or other major markets. And that's because there was a DAA in the market before Harvoni which did treat quite a few people. So there might not have been quite such a large amount of warehousing.

基因型 1 由 Harvoni 治療。我們最初治療了數量龐大的患者。我們不太確定日本的經濟曲線是否與我們在美國或其他主要市場看到的曲線完全相同。這是因為在 Harvoni 之前市場上已經有一款 DAA，它確實治療了不少人。所以倉儲量可能沒有那麼大。

In any case, we're seeing the Harvoni patient numbers coming down gradually. Not quite as steep as some other markets, and that yet to stabilize. But I'm pretty sure -- in fact, I know it will stabilize sometime in the next quarter or two. So that's how we're seeing -- we treated about 30,000 patients during the quarter. So that number -- it will be there or thereabouts, I think, for the rest of the year.

總之，我們看到接受 Harvoni 治療的患者人數正在逐漸下降。雖然不像其他一些市場那樣劇烈波動，但目前尚未穩定下來。但我相當肯定——事實上，我知道它將在未來一兩個季度趨於穩定。這就是我們看到的情況——本季度我們治療了大約 30,000 名患者。所以我認為，在今年剩下的時間裡，這個數字應該會保持在這個水平或附近。

And what about the volume discounts? Are those going to come later in the year? And what kind of dynamics --?

批量折扣呢？這些會在今年稍後推出嗎？以及什麼樣的動態？

I'm sorry -- we're not anticipating any further price movements in this year in Japan.

抱歉，我們預計今年日本的價格不會再有任何進一步的波動。

Great. Thanks for taking my question.

偉大的。謝謝您回答我的問題。

Matthew Harrison, Morgan Stanley.

馬修·哈里森，摩根士丹利。

I had one follow-up on Phil's question on Japan. Can you just be clear with us? The pricing that you talked about in March -- was that the full extent of the 30% price cut, or will there be more in April? Just so we can understand how much was reflected in this quarter.

我針對菲爾關於日本的問題還有一個後續問題。你能跟我們說清楚嗎？您三月提到的價格——那是全部的 30% 降價幅度嗎？還是四月還會有更多降價？這樣我們才能了解本季的情況有多大。

And then on the rebates that you talked about, the true-up that happened -- would you expect that to swing again through the rest of year? Or do you think that that is now at a level that expresses what your forward-looking expectations are for the level of rebates? Thanks.

至於您剛才提到的退款和調整——您認為這種情況會在今年剩餘的時間裡再次波動嗎？或者您認為目前的水平是否已經表達了您對未來返利水準的預期？謝謝。

I'll do the first part, and Robin will talk about the second part. So the pricing in Japan -- the official price reduction was just under 32% and officially from April 1.

我來講第一部分，羅賓來講第二部分。因此，日本的定價——官方降價幅度略低於 32%，並於 4 月 1 日正式生效。

We actually reduced our prices into wholesalers early in March. And the reason for that was because the price cut was announced much earlier, and therefore we wanted to just kind of smooth out the inventory situation. So that's why we reduced our price into wholesalers a little bit earlier.

實際上，我們在3月初就降低了批發商的價格。原因是降價公告發佈得比較早，因此我們想稍微緩解一下庫存狀況。所以，這就是我們之前稍微降低批發商價格的原因。

And by the end of the quarter inventory levels were up to, I would say, reasonable levels relative to demand. And actually a little bit -- those inventory levels are little bit down from where we ended quarter four, because overall demand was slightly down because of Harvoni. Robin?

到季度末，庫存水準已經達到，我認為相對於需求而言是合理的水準。實際上，庫存水準比第四季末略有下降，因為受 Harvoni 的影響，整體需求略有下降。羅賓？

Sure. And so, Matthew, to answer second part of your question relative to the rebate accruals that both Paul and I mentioned: we regularly have to adjust our accruals to reflect the trends in the timing of rebates. And I would say still the trends and the dynamics and the complexity around reimbursement in these markets still make them somewhat difficult to predict. So I wouldn't say they were all one-time in nature.

當然。所以，馬修，關於你提出的第二個問題，即保羅和我提到的退款累積問題：我們必須定期調整我們的累積，以反映退款時間的趨勢。而且我認為，這些市場的報銷趨勢、動態和複雜性仍然使得預測它們變得有些困難。所以，我不會說它們都是一次性的。

There may be a small component that you could say, when we were trying to look at the level of inventory, that maybe was one-time in nature. But these dynamics, I think, we may see continue into the future. And the honest answer is: we don't necessarily know.

可以說，當我們試圖查看庫存水準時，其中可能存在一個很小的組成部分，這或許是一次性的。但我認為，這些趨勢可能會持續到未來。而誠實的答案是：我們未必知道。

Ying Huang, Bank of America Merrill Lynch.

黃穎，美國銀行美林證券。

First of all, I want to probe a little bit about the rebate. Can you clarify whether it's actually access based or volume based? Because we can see from the scripts apparently the volume is not really picking up after those big insurers opened up the access, regardless of F scores. So I wondered what happens there.

首先，我想稍微了解一下退款事宜。能否澄清一下，它究竟是基於存取權限還是基於使用量？從腳本中我們可以看出，儘管 F 分數很高，但在那些大型保險公司開放准入後，交易量似乎並沒有真正增加。所以我很好奇那裡發生了什麼事。

And then secondly, I think, Paul, you mentioned that the payor mix is getting a little bit worse this quarter. But can you talk about your thoughts on payor mix going forward? Is it going to be continuing shift to the public payors or, I guess, the lower-price environment or not? Thank you.

其次，保羅，我想你提到過，本季付款方構成略有惡化。您能否談談您對未來支付方組合的看法？是會繼續向公共支付方轉移，還是會轉向價格較低的醫療環境？謝謝。

So the first question was about patient volumes coming in and relative to the opening up of the fibrosis scores. So I'm not sure whether you look at this data or not, but we get new-to-brand data, which is really the leading indicator of new starts in the quarter. So we've seen -- and this is just retail scripts, by the way; so that doesn't include the VA; it doesn't include scripts that go through ESI and various other groups. So it's partly representative.

所以第一個問題是關於入院病人數量以及纖維化評分的開放情況。所以我不確定您是否會查看這些數據，但我們獲得了新品牌數據，這實際上是本季新開戶量的領先指標。所以我們看到——順便說一下，這只是零售腳本；所以不包括 VA；也不包括透過 ESI 和其他各種團體的腳本。所以它具有一定的代表性。

And what we've seen amongst those scripts is new starts in the quarter have gone up. And that's gone up exactly in line with our expectations with the fibrosis scores being released.

我們從這些劇本中看到的情況是，本季的新開工量有所增加。隨著纖維化評分的公佈，這一數字的上升與我們的預期完全一致。

Total scripts have remained relatively flat. And part of that is because in quarter four, of course, the patient numbers -- well, throughout really 2015 quarter on quarter the new starts were coming down. And therefore the refills associated with those new starts falling into quarter one were somewhat down. So the aggregate of that makes the numbers of total prescriptions in the quarter look relatively flat and slightly disengaged from the fibrosis piece. So I think that hopefully covers that part.

劇本總數基本上保持穩定。部分原因是，當然，在第四季度，患者人數——實際上，2015 年每季的新病例都在下降。因此，與第一季新開始的訂單相關的補貨量有所下降。因此，綜合來看，該季度處方總數看起來相對平穩，並且與纖維化部分略有脫節。我想這部分應該要涵蓋到了。

And then, of course, the VA, as I said, isn't included in that group. And that was a large number of patients coming into the system.

當然，正如我所說，退伍軍人事務部並不包含在這個群體中。當時有大量患者湧入醫療體系。

And then the payor mix?

那麼，付款方組合又是怎麼樣的呢？

The payor mix, I think, directionally -- I mean, this is not a dramatic move. I think directionally we anticipate that Medicaid will start. There's a lot of pressure on Medicaid to treat patients. And we anticipate that the public payor sector will start proportionately getting a little bit bigger in our mix.

我認為，支付方組合的變化方向——我的意思是，這並不是一個劇烈的轉變。我認為從方向上看，我們預計醫療補助計劃將會啟動。醫療補助計劃面臨治療患者的巨大壓力。我們預期公共支付部門在我們業務組成中所佔的比例將會逐漸增加。

I mean, just as an example, around 77% of our payor mix at the end of quarter four, during quarter four, was really commercial and Medicaid Part D. That number has dropped down now to about 64% as a proportion. So we're seeing a shift, and I would imagine that that will continue gradually.

舉個例子來說，在第四季末，也就是第四季期間，我們支付方組合中約有 77% 是商業保險和 Medicaid Part D。現在這個比例已經下降到約 64%。所以我們看到了一種轉變，而且我認為這種轉變會逐漸持續下去。

And then would you guys ever talk about the relative magnitude compared to 46% you flagged last year?

那麼，你們是否會討論一下與去年你們指出的 46% 相比，這個數字的相對幅度呢？

No, we're not going to give guidance on our guidance. We gave the gross net number once. We've built that into our guidance for the rest of the year. So we're not planning on breaking that out at all.

不，我們不會就我們的指導方針提供指導。我們只給過一次毛淨值。我們已將此納入今年剩餘時間的指導方針中。所以我們完全沒有計劃這麼做。

Thank you, Paul.

謝謝你，保羅。

Robyn Karnauskas, Citi.

Robyn Karnauskas，花旗銀行。

Just thinking about the moving parts over the course of the year and the color you gave on fibrosis scores -- so with so many people getting rejected early on based on fibrosis score, how might they flow into the system during the year? Because there's a lot of patients; do you see them coming on evenly? Or could they come in a bolus, and we could see some choppiness in the quarters?

想想一年中不斷變化的情況，以及你對纖維化評分的描述——由於許多人因為纖維化評分而被早期拒絕，那麼在這一年中，他們如何順利進入治療系統？因為病人很多，你覺得他們的病情進展是否均勻？或者它們會以團注的形式出現，我們可能會看到四分之一的波動？

And then the second question I had was: how comfortable are you that you can -- that some of the pricing negotiations will -- have been done, and we won't see further pricing negotiations coming with the new nuc-based regimens coming next year? Do you think there's going to be another round of surprises in 2017 for discounting? Or do you think we've reached a little bit lower of a steady-state? Thanks.

然後我的第二個問題是：您有多大把握認為一些價格談判已經完成，並且明年隨著新的核療法的推出，我們不會看到進一步的價格談判？你認為2017年折扣方面還會出現新一輪的驚喜嗎？還是你認為我們已經達到了比穩定狀態略低的水平？謝謝。

You know, I think it's hard to tell on the flow of patients, first of all. What we do know is there's plenty, plenty patients out there. As I said, we have -- our data, we've got three different sources of data which shows that 25,000 to 30,000 patients are coming into treatment. Obviously, a lot less than that are actually being treated.

你知道，首先，我認為很難判斷病人的流動。我們知道的是，有很多很多病人。正如我所說，我們有——我們的數據，我們有三個不同的數據來源，數據顯示有 25,000 至 30,000 名患者正在接受治療。顯然，實際接受治療的人數要少得多。

And anecdotally, as I said, I think it's because there's bureaucracy still in the physicians' offices, which give a kind of -- you know, I guess that's sort of gating in a sense, the number of patients that can be treated. And also, it's from the patient's side, you know, people are actually ready to be treated. I think they want to be teed up, if you like, for treatment; but they might not want to actually start tomorrow morning. So I think we should expect patient flow to be fairly stable through this year.

正如我剛才所說，根據我的觀察，我認為這是因為醫生辦公室裡仍然存在官僚主義，這在某種程度上限制了可以治療的病人數量。而且，從患者的角度來看，人們實際上已經做好了接受治療的準備。我認為他們想為治療做好準備；但他們可能不想明天早上就開始治療。所以我認為今年患者流量應該會比較穩定。

And then on the negotiation side, I mean, I think with real-world data, payors are tending now to really take a lot more time and put a lot more thought into evaluating the clinical profiles of the product. And you know, until we see the clinical profiles of the new products, it's very hard to predict how competitive they are.

而在談判方面，我認為有了真實世界的數據，支付方現在往往會花更多的時間，投入更多的思考來評估產品的臨床概況。你知道，在看到新產品的臨床數據之前，很難預測它們的競爭力如何。

I mean, if they are competitive, I think we have to anticipate prices will come down, and we'll negotiate. Because we certainly don't want to lose any access to patients for our product. And we'll defend our market share vigorously.

我的意思是，如果他們有競爭力，我認為我們應該預料到價格會下降，然後我們會進行談判。因為我們當然不想失去任何患者使用我們產品的機會。我們將全力捍衛我們的市場佔有率。

So it's hard to predict. I think directionally, competition equals lower prices. But we are going to be focusing on looking at differentiating our product. We've got great products out there now, and our pipeline looks really exciting. So I think we're in good shape for a long and sustainable and healthy HCV business in the US.

所以很難預測。我認為從趨勢來看，競爭會導致價格下降。但我們將專注於如何使我們的產品脫穎而出。我們現在有很多優秀的產品，而且我們的產品線看起來也非常令人興奮。所以我認為，我們在美國擁有長期、可持續且健康的丙肝業務，前景良好。

Thanks.

謝謝。

Alethia Young, Credit Suisse.

Alethia Young，瑞士信貸。

Just one -- like, if we go back to the beginning of this year and think about, like, the $30 billion to $31 billion you put out there, has the mix between hep C and HIV changed? It seems like HIV is going little bit better on the new launch, and Hep C has more pricing pressure.

舉個例子──如果我們回到今年年初，想想你們投入的 300 億到 310 億美元，C肝和愛滋病毒的比例是否改變了？HIV疫苗新上市的情況似乎略好一些，而C肝疫苗則面臨更大的價格壓力。

And then just also can you confirm, maybe, if we are seeing any competition in the big five from, like, kind of new competitors like Merck coming to the market?

另外，您能否確認一下，我們是否看到像默克這樣的新競爭對手進入市場，對五大製藥公司構成競爭？

Maybe, Alethia, I could take the first part of your question. This is Robin. We gave guidance for the full year. I would say, yes, this quarter we had a slightly uptick relative to our HIV expectations and slightly down relative to HCV. But I think we have still got three quarters to play things out. And as Paul said, we continue to be optimistic relative to patient starts and a more stable, predictable environment going forward. But it's still very early to tell.

阿萊西亞，或許我可以回答你問題的第一部分。這是羅賓。我們提供了全年的指導意見。是的，本季我們的 HIV 感染人數略高於預期，而 HCV 感染人數略低於預期。但我認為我們還有四分之三的時間來把事情弄清楚。正如保羅所說，我們對患者開始治療以及未來更穩定、可預測的環境仍然保持樂觀。但現在下結論還為時過早。

Yes. And in Europe, I've got to say, the payors are treating the products generally with less consideration to the clinical differences than we are seeing in the US. And there are some payors who are treating the products a bit more like commodities. And we are working hard to make sure that we educate them as best as possible. And I think the real-world data, much of which originates from Europe, is really supporting us in that.

是的。在歐洲，我必須說，當支付方對待這些產品時，通常不太重視臨床差異，而我們在美國則看到了這種情況。也有一些付款方將這些產品視為商品。我們正在努力確保盡可能地對他們進行最好的教育。我認為現實世界的數據，其中許多來自歐洲，確實支持了我們的觀點。

But we have seen some instances of, for example, tenders in the Nordics which have a very binary outcome. And there are certain times that, you know, we've decided that those tenders' prices don't warrant the value of our product. So our market shares have been a little bit less than Europe. And specifically, to answer your question, I think all three players are out there in Europe trying to get business.

但我們看到，例如北歐的一些招標項目，其結果只有兩種可能。你知道，有時候我們會覺得，那些投標的價格並不能反映我們產品的價值。因此，我們的市佔率比歐洲略低。具體來說，回答你的問題，我認為這三傢俱樂部都在歐洲努力拓展業務。

But at the end of the day, we hope that people will recognize that the Gilead products are highly effective, very simple, very tolerable. And the real-world data, which is now -- you know, there's vast amounts of it -- really does support us when physicians make their choices. And as I said earlier, where physicians have the freedom of prescription, we've tended to have very, very strong market shares, in the 90%-plus.

但歸根究底，我們希望人們能夠認識到吉利德的產品是高效、簡單、耐受性好。而現實世界的數據——你知道，現在這類數據非常多——確實能夠為醫生做出選擇提供支援。正如我之前所說，在醫生擁有處方自由的地方，我們往往擁有非常非常強大的市場份額，超過 90%。

Ian Somaiya, BMO Capital.

Ian Somaiya，BMO Capital。

Thanks. Maybe just change the topic a little bit -- a question for Norbert. I was hoping you could just speak to the three oral candidates you have for NASH now, just how they would -- how you are planning to develop them; how they might then play potential combination strategies. And as you kind of think about the larger BD question that keeps being asked, do you have enough data on your internal programs to make decisions in terms of what additional products that might benefit your internal efforts in NASH and also in hep B?

謝謝。或許我們可以稍微換個話題──問諾伯特一個問題。我希望您能和您目前篩選出的三位 NASH 口試候選人談談，您打算如何培養他們；以及他們可能會如何運用潛在的組合策略。當你思考 BD 不斷被問及的更大的問題時，你是否有足夠的內部項目數據來決定哪些額外的產品可能有利於你在 NASH 和乙肝方面的內部努力？

So, Ian, actually it's four products that we have currently in early clinical studies, if you include the Nimbus compounds. That deal, by the way, has not closed yet. But it should close in the next week.

所以，伊恩，實際上，如果把Nimbus化合物也算進去的話，我們目前有四款產品正在進行早期臨床研究。順便一提，那筆交易還沒完成。但應該會在下週關閉。

So we have the ASK inhibitor, the ACC 1/2 inhibitor, the simtuzumab, and then the FXR agonist. And we could by the end of this year be in four Phase 2 studies, really, you know, in NASH, to look at the effect of any one of these agents by themselves. And then we would also at the same time look at our star combination studies to see -- you know, too, we always have said we believe in the three points of [PET] disease pathogenesis. There's fibrosis, inflammation, and metabolic. And we now have agents that address all of them.

所以我們有 ASK 抑制劑、ACC 1/2 抑制劑、simtuzumab，還有 FXR 激動劑。到今年年底，我們可能會進行四項 2 期研究，實際上是針對 NASH 的，目的是研究這些藥物中的任何一種單獨使用的效果。同時，我們也會研究我們的明星組合研究，看看——你知道，我們也一直說我們相信[PET]疾病發病機制的三個要點。存在纖維化、發炎和代謝紊亂。現在我們有專門的代理人來處理所有這些問題。

And we're absolutely -- our hypothesis is that ultimately it's a complex biological disease and probably more than one agent will be needed. And we're looking forward -- maybe sometime next year we will then go to Phase 3.

我們絕對認為——我們的假設是，歸根結底，這是一種複雜的生物學疾病，可能需要不只一種藥物。我們期待著——也許明年某個時候我們將進入第三階段。

With regards to BD, we're of course looking. At the moment there is nothing out there that I would say we have to get -- as I said, we have four components. We are going to look at those individually and then, as the results come in, make decisions what else we would need.

至於BD方面，我們當然在關注。目前還沒有什麼是我認為我們必須要買的東西——正如我所說，我們有四個組成部分。我們將逐一研究這些問題，然後根據結果決定我們還需要什麼。

And then what about hep B? It's a similar question. Just with the assets you do have -- I know that you have provided very little information or shared very little information with us. But just as you think about your internal portfolio, do you feel like you have the assets you need to move forward with them and, obviously, capture the market?

那麼乙肝呢？這是一個類似的問題。僅憑你現有的資產——我知道你提供給我們的資訊或分享的資訊非常少。但就像你思考你的內部投資組合一樣，你是否覺得你擁有推進這些投資組合併最終佔領市場所需的資產？

I would say, Ian, so we have, as you know, 4774 -- 4779, that's the GlobeImmune vaccine. We presented data at last AASLD showing that at least in virally-suppressed patients, it did not lead to a reduction in its antigen. We are currently doing a study in treatment-naive patients. We then have 9620 to [deal our seven] agonists in Phase 2 as well or Phase 2a. And then we have two other internal programs that we haven't disclosed yet. They are pre-IND, but we have identified with two different mechanisms, molecules that we want to develop or evaluate in human clinical studies.

伊恩，我想說，正如你所知，我們有 4774 到 4779，那是 GlobeImmune 疫苗。我們在上屆 AASLD 會議上公佈的數據表明，至少在病毒受到抑制的患者中，它不會導致其抗原減少。我們目前正在對未經治療的患者進行研究。然後我們還有 9620 來處理我們的七個激動劑，進入 2 期或 2a 期。此外，我們還有兩個尚未公開的內部項目。它們目前處於臨床試驗申請前階段，但我們已經確定了兩種不同的作用機制，我們希望在人體臨床研究中開發或評估這些分子。

But having that said, it's early -- I mean as a general statement -- in hepatitis B cure. And we are really having a very open mind and looking outside: what else is there potentially that would fit our portfolio?

但話雖如此，就乙肝治癒而言，現在下結論還為時過早——我的意思是，就總體而言。我們真的非常開放，並且向外看：還有哪些東西有可能適合我們的投資組合？

Terence Flynn, Goldman Sachs.

特倫斯·弗林，高盛集團。

I was just wondering -- you mentioned this 25,000 to 30,000 per month number of patients coming into treatment and then gave us the new diagnosis last year in the US. So that equates to about 17,000 per month. So is it safe to assume that of the new patients coming out of treatment, half are newly diagnosed and half are coming from the currently diagnosed pool? Am I thinking about that the right way?

我只是想問一下——您提到每月有 25,000 至 30,000 名患者前來接受治療，然後告訴我們去年在美國出現了新的診斷結果。那相當於每月約 17,000。那麼，我們可以合理地假設，在接受治療的新患者中，有一半是新確診的患者，一半是來自目前已確診的患者族群嗎？我這樣想對嗎？

And then the second question was just -- can you tell us the percentage of patients that are getting 8 weeks of therapy this quarter? Thank you.

第二個問題是—您能告訴我們本季接受 8 週治療的患者百分比嗎？謝謝。

I think, broadly speaking, your math is correct on that. It's hard to tell exactly where the patients are coming from. But I think mathematically that sounds about right.

我認為，總的來說，你的計算是正確的。很難確切地說出這些病人來自哪裡。但我認為從數學角度來看，這聽起來差不多是對的。

Sorry, what was the second question? Oh, yes, sorry. Eight weeks -- yes. We've drifted slowly but surely upwards on the eight weeks. I think were about 43% now. I've got to emphasize: the data we have is called intent to treat rather than actual prescriptions. So the intent to treat in the US is about 43%.

抱歉，第二個問題是什麼？哦，是的，抱歉。八週——是的。八週以來，我們一直穩定上升。我認為我們現在大約佔43%。我必須強調：我們掌握的數據是意向性治療數據，而不是實際處方數據。因此，美國的治療意願約為 43%。

The epidemiology, as we previously said, we probably suggest about half genotype 1 patients would fall into the criteria that would trigger off eight-week treatment.

正如我們之前所說，根據流行病學數據，我們推測大約一半的 1 型基因型患者將符合觸發八週治療的標準。

Jim Birchenough, Wells Fargo.

吉姆·伯奇諾，富國銀行。

A bit of a maintenance question and then a more meaningful question. On the maintenance side, you referred to a bit of a shift from 24 weeks to 8 weeks. Could you break down the 8-, 12-, and 24-week treatment numbers in HCV and where you see that heading?

先問一個維護方面的問題，然後再問一個更有意義的問題。在維護方面，您提到維護週期從 24 週縮短到 8 週。您能否詳細分析一下丙型肝炎治療中 8 週、12 週和 24 週的治療數據，以及您認為該數據來自哪裡？

And the more meaningful question is: NASH is obviously an important part of your future growth strategy. FXR is in that category. How confident are you that you can separate out the metabolic effects of FXR agonism versus the beneficial effects? What's the basis for that (technical difficulty) and when will we see that data? Thanks.

而更有意義的問題是：NASH 顯然是您未來成長策略的重要組成部分。FXR就屬於這一類。你有多大把握能夠將 FXR 激動劑的代謝效應與有益效應區分開來？（技術難題）的依據是什麼？我們什麼時候才能看到這些數據？謝謝。

We're not going to break down the weeks of therapy. I mean, I just said what we think the eight-week amount is. But the rest of you'll have to just model yourself. And I'll hand it over to Norbert for the second question.

我們不會詳細分析幾週的治療過程。我的意思是，我剛才說了我們認為八週的時間是多少。但你們其他人就只能自己示範了。接下來，我將把問題交給諾伯特，由他來回答第二個問題。

So, Jim, as you know, steroids FXR agonists do many, many things, not only in the liver but in also other target organs. So our philosophy is that we have an FXR agonist that purely acts at the level of the G.I. So it does not get totally absorbed to any meaningful degree.

吉姆，如你所知，類固醇 FXR 激動劑有很多作用，不僅作用於肝臟，還作用於其他目標器官。所以我們的理念是，我們有一種 FXR 激動劑，它完全作用於胃腸道層面。因此，它不會被完全吸收，也不會有任何實質的吸收。

And then what it does -- at the level of the G.I., it releases FGF 19. And we believe that FGF 19 does everything that it needs to do in order to impact on NASH. That's our hypothesis, and we are testing that. And we should have data available in the fourth quarter of this year.

然後，它在胃腸道層面上釋放FGF 19。我們相信 FGF 19 能夠發揮其對 NASH 產生影響所需的一切作用。這是我們的假設，我們正在驗證它。我們應該會在今年第四季取得相關數據。

So that's a fairly easy experiment to do. You simply look at bioavailability, which is below, but the FGF -- might increase the FGF 19 levels with some of the consequent metabolic effects. That way we also think we can prevent pruritus. We can prevent the cholesterol effects. We can prevent alkaline phosphatase elevations, et cetera. And so if this all is true, it should be a much safer and cleaner FXR agonist.

所以這是一個相當容易做的實驗。你只需查看生物利用度（如下所示），但 FGF 可能會增加 FGF 19 水平，並產生一些相應的代謝效應。我們認為這樣也能預防搔癢。我們可以預防膽固醇帶來的影響。我們可以預防鹼性磷酸酶升高等問題。因此，如果這一切都是真的，那麼它應該是一種更安全、更純淨的 FXR 激動劑。

And Norbert, what is the forum for that data release? And what are the next steps for that program? How far behind are you from things that are in Phase 3 right now as FXR agonists?

諾伯特，請問這些數據會在哪個論壇發布？該計劃的下一步是什麼？你們的藥物與目前處於 FXR 激動劑三期臨床試驗階段的藥物相比，差距有多大？

We could probably have some of the preliminary data at AASLD, and we would then move into Phase 3 soon after that. So we're not that far behind other companies.

我們或許可以在 AASLD 上取得一些初步數據，然後很快就能進入第三階段。所以，我們和其他公司的差距並不大。

Great. thanks for taking the questions.

偉大的。謝謝您回答問題。

Alan Carr, Needham & Company.

艾倫·卡爾，尼德姆公司。

I'm wondering if you can talk a bit more about the new diagnoses in 2015 that you mentioned? You said there was around 200,000. Do you have any other details around that -- about where they were found, or I guess the trend over the course of the year? Is it increasing? Thanks.

我想請您再詳細談談您提到的2015年的新診斷結果？你說大約有20萬。您還有其他細節嗎？例如它們是在哪裡被發現的，或是這一年的趨勢？是否在增加？謝謝。

I don't have a lot of details at my fingertips, actually, Alan. I would say, just to build on what Norbert was saying earlier, the interactions we are having with many people working on diagnosis projects around the country are that there's a lot of -- a surprisingly high level of positive diagnosis in some of the urban centers, and in the ER rooms in particular in those urban centers, where diagnosis rates have been double at least what even the local investigators have anticipated.

艾倫，說實話，我手邊並沒有太多細節資訊。我想補充一下諾伯特之前所說的，我們與全國各地許多從事診斷項目的人員交流後發現，一些城市中心，尤其是這些城市中心的急診室，陽性診斷率出奇地高，至少是當地調查人員預期的兩倍。

Why that is, I'm not sure. But this has been consistent throughout the country. So I would say that diagnosis rates, the 200,000, would grow rather than shrink, certainly for the next few years. And there's great efforts, of course, now to encourage diagnosis, because people know that at the end of it, they're going to be treated and have a high probability of being cured.

我也不確定原因。但這種情況在全國範圍內都是一致的。所以我認為，診斷率（20萬例）在未來幾年內肯定會成長而不是下降。當然，現在人們也在大力鼓勵診斷，因為人們知道，最終他們會得到治療，並且有很高的治癒幾率。

Great. Thanks very much.

偉大的。非常感謝。

Tony Butler, Guggenheim.

東尼巴特勒，古根漢美術館。

Norbert, very quickly, if you could -- recognizing that Nimbus closes next week, have there not been other ACC inhibitors which have actually failed? And if that's true, what might be unique about the Nimbus program? I understand it may attack a different part of the molecule, which would be interesting for you to elaborate on, if that isn't the case. Thanks.

Norbert，如果你可以的話，請你快速回答一下——考慮到 Nimbus 下週就要關閉了，難道就沒有其他 ACC 抑制劑實際上已經失敗了嗎？如果是這樣，Nimbus 計畫的獨特之處又是什麼呢？我知道它可能會攻擊分子的不同部分，如果不是這種情況，我很希望你能詳細說明。謝謝。

Yes, so Tony, you're exactly right; there have been previous ACC programs at Merck and Pfizer. They have not been successful, and the reason had to do with the specificity. This compound is really unique. It's a low nanomolar inhibitor of both ACC-1 and ACC-2.

是的，東尼，你說得完全正確；默克和輝瑞之前都有過 ACC 項目。他們並沒有成功，原因在於具體性問題。這種化合物非常獨特。它是 ACC-1 和 ACC-2 的低納摩爾抑制劑。

It then inhibits not only the pathway that goes to the [nova like progenesis], so no coenzyme A production; but it also inhibits at the level of the mitochondrion. It stimulates, I might say, lipid acid beta oxidation. So it does really two things. It inhibits the formation of lipids, palmitate mostly, and at the same time it stimulates the beta oxidation of lipids.

它不僅抑制了通往[類似新星的生殖]的途徑，從而阻止了輔酶A的產生；而且還抑制了粒線體層面的生殖。可以說，它能促進脂質β氧化。所以它實際上做了兩件事。它抑制脂質（主要是棕櫚酸酯）的形成，同時刺激脂質的β氧化。

And so there has been some anecdotal reports from the Pfizer compound that inhibition of ACC-1 and 2 results in a decrease in liver fat. That's, by the way, something we would do as one of the next experiments. We would look by MRI on reduction of -- we have already shown at the EASL presentation that it inhibits lipogenesis. Now we have to show also that it inhibits lipids fat content of the liver.

因此，有傳聞稱，輝瑞公司研發的化合物抑制 ACC-1 和 2 可減少肝臟脂肪。順便一提，這是我們接下來要進行的實驗之一。我們將透過 MRI 觀察其減少情況——我們已經在 EASL 會議上證明，它能抑制脂肪生成。現在我們也要證明它能抑制肝臟中的脂質和脂肪含量。

It's a very straightforward and easy experiment to do. And I think once we have shown that we have pretty high confidence, that there will be a meaningful clinical benefit of the compound.

這是一個非常簡單易行的實驗。我認為，一旦我們證明我們有相當高的信心，該化合物將具有顯著的臨床益處。

Great, thank you.

太好了，謝謝。

Thank you, Candace, and thank you all for joining us today. We appreciate your continued interest in Gilead. And the team here look forward to providing you with updates on our future progress.

謝謝坎迪斯，也謝謝各位今天蒞臨現場。感謝您一直以來對吉利德的關注。我們團隊期待向您報告我們未來的進展。

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Have a great day, everyone.

女士們、先生們，感謝各位參加今天的會議。程式到此結束，各位可以斷開連接了。祝大家今天過得愉快。