吉利德科學 (GILD) 2016 Q3 法說會逐字稿

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

女士們、先生們，感謝您的耐心等待，歡迎參加吉利德科學公司2016年第三季財報電話會議。我是坎迪斯，今天將擔任本次會議的接線生。

(Operator Instructions)

（操作說明）

I would now like to turn the call over to Sung Lee, Vice President of Investor Relations.

現在我將把電話交給投資人關係副總裁李成先生。

Thank you, Candace, and good afternoon, everyone.

謝謝你，坎迪斯，大家下午好。

Just after market closed today, a press release was issued with earnings results for the third quarter of 2016. The press release and detailed slides are available on the investor relations section of the Gilead website. Joining today's call will be John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; Kevin Young, Chief Operating Officer; and Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer.

今天股市收盤後不久，吉利德公司發布了2016年第三季財報。新聞稿及詳細投影片可於吉利德公司網站的投資者關係頁面查閱。出席今天電話會議的有：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；營運長凱文·楊；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 will 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.

在正式發言之前，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、財務預測和資金使用的計劃和預期。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，可能導致實際結果與這些聲明有重大差異。有關這些風險的描述，請參閱最新的美國證券交易委員會（SEC）揭露文件和近期發布的新聞稿。

In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call. 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. I will now turn the call over to Robin.

此外，吉利德不承擔更新本次電話會議中任何前瞻性陳述的義務。我們將使用非公認會計準則（Non-GAAP）財務指標來幫助您了解公司的實際業務表現。公認會計準則（GAAP）與非公認會計準則（Non-GAAP）的調節表已在獲利新聞稿和吉利德網站上提供。現在我將把電話會議交給羅賓。

Thank, Sung, and good afternoon, everyone.

謝謝宋，大家午安。

We're pleased to share results for the third quarter of 2016. I will first review our financials and Kevin, Norbert and John will then make a few comments. Total revenues for the third quarter were $7.5 billion with non-GAAP diluted earnings per share of $2.75.

我們很高興與大家分享2016年第三季的業績。我將先介紹我們的財務數據，之後Kevin、Norbert和John將分別作簡要說明。第三季總營收為75億美元，非GAAP攤薄後每股收益為2.75美元。

This compares to revenues of $8.3 billion and non-GAAP earnings per share of $3.22 for the same period last year. Product sales for the third quarter were $7.4 billion, down 10% year-over-year and down 3% sequentially. These declines were due to lower HCV sales, partially offset by increased sales in HIV and other therapeutic areas. Sequentially, declines in our HCV sales in the US, Japan and Europe were partially offset by increases in the US HIV and other product sales.

相較之下，去年同期營收為83億美元，非GAAP每股收益為3.22美元。第三季產品銷售額為74億美元，年減10%，季減3%。這些下降主要歸因於C型肝炎（HCV）產品銷售額的降低，但部分被愛滋病（HIV）和其他治療領域的銷售額成長所抵消。環比來看，美國、日本和歐洲C型肝炎產品銷售額的下降部分被美國愛滋病和其他產品銷售額的成長所抵銷。

Turning to the US, product sales for the third quarter were $5.1 billion, down 9% year-over-year. HCV product sales were $2 billion, down 37% year-over-year, driven primarily by lower patient starts for Harvoni and lower revenues per patient, primarily due to a higher percentage of sales to more deeply discounted segments. The decline was partially offset by demand for Epclusa, which was launched at the end of Q2 2016 and generated $593 million in its first full quarter of sales. Sequentially, our HCV product sales were down 12%. These sales were essentially flat compared to the second quarter excluding the favorable adjustments for HCV sales return of $279 million that we made last quarter.

轉至美國市場，第三季產品銷售額為51億美元，較去年同期下降9%。丙型肝炎產品銷售額為20億美元，年減37%，主要原因是Harvoni的患者起始治療量減少以及每位患者的收入下降，而這主要是由於更多折扣產品被納入銷售管道所佔比例較高。 Epclusa的需求部分抵銷了這一降幅，該產品於2016年第二季末上市，在首個完整季度實現了5.93億美元的銷售額。環比來看，我們的C型肝炎產品銷售額下降了12%。若不計入上季丙型肝炎銷售回升帶來的2.79億美元有利調整，這些銷售額與第二季基本持平。

HIV and other antiviral sales increased 32% year-over-year and 19% sequentially. The quarterly revenues of $2.6 billion were positively impacted by strong uptake of our TAF-based regimens and a one-time favorable adjustment of $332 million to our rebate reserves, primarily related to our TDF-based regimens. Without the adjustment, US HIV and other antiviral sales grew 15% year-over-year and 4% sequentially.

HIV 及其他抗病毒藥物銷售額較去年同期成長 32%，較上季成長 19%。季度營收達 26 億美元，主要得益於基於 TAF 的治療方案的強勁市場需求，以及一次性 3.32 億美元的返利儲備金調整，該調整主要與基於 TDF 的治療方案相關。若不計入此調整，美國 HIV 及其他抗病毒藥物銷售額年增 15%，季增 4%。

Turning to Europe, product sales for the third quarter were $1.4 billion, down 16% year-over-year primarily due to lower HCV patient starts and unfavorable currency movement. Sequentially, sales were down 12%, primarily driven by lower HCV patient starts and summer seasonality consistent with the usual decreases in demand during the European summer holiday months. In Japan, product sales for the third quarter were $452 million, flat year-over-year driven by higher sales of Harvoni, which was launched in September 2016, offset by mandatory price reduction for both Sovaldi and Harvoni, which we discussed during our last call. Sequentially, sales were down 27% as a result of lower Harvoni and Sovaldi patient starts.

在歐洲，第三季產品銷售額為14億美元，年減16%，主要原因是C型肝炎患者新增病例減少以及不利的匯率波動。環比下降12%，主要原因是丙型肝炎患者新增病例減少以及夏季季節性因素，這與歐洲夏季假期期間的通常需求下降趨勢一致。在日本，第三季產品銷售額為4.52億美元，與去年同期持平，主要得益於2016年9月上市的Harvoni銷量增長，但被Sovaldi和Harvoni的強制性降價所抵消，我們在上次電話會議中已討論過此事。季減27%，原因是Harvoni和Sovaldi的患者新增病例減少。

Now, turning to expenses, non-GAAP R&D expenses were $981 million for the third quarter, up 38% compared to the same period last year, primarily due to the progression of our clinical study, which included a $200 million milestone expense associated with our purchase amendment. Non-GAAP SG&A expenses for the third quarter were down 8% compared to the same period last year primarily due to lower branded prescription drug fee expense.

接下來談談費用。第三季非GAAP研發費用為9.81億美元，較去年同期成長38%，主要原因是臨床研究的進展，其中包括與收購協議修訂相關的2億美元里程碑付款。第三季非GAAP銷售、管理及行政費用較去年同期下降8%，主要原因是品牌處方藥費用支出減少。

From a balance sheet perspective, during the third quarter we generated cash flows from operation of $4.3 billion and ended the quarter with $31.6 billion in cash and investments, which is inclusive of the issuance of $5 billion of senior unsecured notes. We have a healthy balance sheet to invest in our pipeline and external opportunity. While our cash flows will remain strong, we do anticipate a sequential decrease in Q4 2016, due to required cash payments related to accrued government rebates, as well as milestone payments associated with our R&D pipeline.

從資產負債表角度來看，第三季我們經營活動產生的現金流為43億美元，季末現金及投資總額為316億美元，其中包括發行的50億美元優先無抵押債券。我們擁有健康的資產負債表，可以投資我們的在研項目和外部投資機會。雖然我們的現金流將保持強勁，但由於需要支付與應計政府補貼相關的現金以及與研發項目相關的里程碑付款，我們預計2016年第四季現金流將較上季下降。

Shareholder return via dividends and share repurchases year-to-date remain strong. In the third quarter we repurchased 11.7 million shares for $1 billion under the $12 billion 2016 share repurchase program. For 2016, the total share repurchases through the third quarter were 110 million shares at a cost of $10 billion. Year-over-year we have seen an 11% decline in our diluted shares primarily driven by purchases. Finally, we are reiterating our full-year 2016 guidance, which was revised on July 25, 2016 and summarized on slide 27 in the earnings results presentation available on our corporate website.

今年迄今為止，透過分紅和股票回購實現的股東回報依然強勁。第三季度，我們根據2016年120億美元的股票回購計劃，回購了1,170萬股，總額達10億美元。 2016年截至第三季度，股票回購總額為1.1億股，總成本為100億美元。與去年同期相比，我們的稀釋後股份數量下降了11%，這主要是由於股票回購所致。最後，我們重申2016年全年業績指引，該指引已於2016年7月25日修訂，並在公司網站提供的盈利報告簡報第27頁進行了概述。

As a reminder, guidance for product sales is subject to a number of uncertainties, including an uncertain local macroeconomic environment, adoption of additional pricing measures to reduce HCV spending, volatility in foreign currency exchange rates, inaccuracy 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 payers and a larger than anticipated shift in payer mix to more highly discounted payer segments such as PHS, FSS and Medicaid and the VA.

提醒各位，產品銷售指導受多種不確定因素影響，包括當地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不准確、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持續合同和未來談判而導致的折扣、退款和回扣，以及支付方回扣和回扣服務

I would like to turn the call over to Kevin now.

現在我想把電話交給凱文。

Thank you, Robin, and good afternoon, everyone.

謝謝你，羅賓，大家下午好。

I am very pleased to take you through a solid set up operating results for the third quarter. Starting with HIV, Gilead continues to make significant steps in delivering improved, single tablet regimens to patients around the world. We have seen strong adoption of our top-based regimens in the US and in the European markets where we have achieved reimbursement.

我很高興向大家介紹吉利德第三季穩健的營運表現。首先是HIV領域，吉利德在為全球患者提供改良的單片療法方面持續取得重大進展。我們看到，在美國和已獲得醫療保險報銷的歐洲市場，我們以頭孢菌素為基礎的療法得到了廣泛應用。

In the US, of the nearly 840,000 people on antiretroviral therapy, approximately 80% receive a Gilead regimen. Genvoya is now the most prescribed regimen for both treatment-naive and switch patients. This month we expect cumulative prescriptions of Genvoya to surpass the [triples] prescription at the same point in time post-approval. This will make Genvoya the all-time most successful product adoption in its first year in the 30 year history of HIV therapy in this country.

在美國，近84萬接受抗病毒療法的患者中，約有80%使用吉利德公司的方案。 Genvoya目前是初治患者和換藥患者中最常使用的方案。我們預計Genvoya在本月的累積處方量將超過核准後同期處方量的三倍。這將使Genvoya成為美國30年HIV治療史上首年最成功的產品。

The uptick of Genvoya, Odefsey and Descovy have largely been driven by the switch from Gilead's old STRs due to the improved safety profile of TAF. But it is also encouraging to see a notable number of patients from non-Gilead therapies moving to top-based regimens. Approximately 10% of Genvoya switches are incremental to the Gilead HIV franchise.

Genvoya、Odefsey 和 Descovy 的使用量激增，主要得益於患者從吉利德原有的單株抗體藥物（STR）轉向使用 TAF，因為 TAF 的安全性更高。但令人鼓舞的是，也有相當數量的患者從非吉利德療法轉向使用基於標靶的治療方案。 Genvoya 的轉換用戶中，約有 10% 是吉利德 HIV 產品線新增用戶。

Turning to Europe, total HIV and other antiviral revenue were $728 million, up 1% year-over-year and down 4% sequentially. Third quarter European [funds to do] revenues are typically affected by summer seasonality. In Italy, Spain and Portugal we saw lower prescribing rates consistent with prior years.

再來看歐洲市場，HIV及其他抗病毒藥物總收入為7.28億美元，較去年同期成長1%，較上季下降4%。歐洲第三季的營收通常會受到夏季季節性因素的影響。在義大利、西班牙和葡萄牙，我們看到處方率下降，與往年情況一致。

Genvoya has been launched in 18 markets in the in the EU, including Spain and Germany where we are seeing rapid uptick, similar to the US. Descovy has been launched and nine markets and Odefsey has been launched in eight markets, the largest being Germany in both cases.

Genvoya已在歐盟18個市場推出，包括西班牙和德國，這兩個國家的成長速度與美國類似，都呈現快速成長態勢。 Descovy已在9個市場推出，Odefsey已在8個市場推出，其中德國是最大的市場。

We expect our top-based therapies to continue to grow in Europe with Spain still early in its commercial launch of Genvoya. Pricing and reimbursement discussions are ongoing in France and Italy with the goal of having these complete by year-end.

我們預計，在歐洲，我們的頭部治療產品將繼續成長，其中Genvoya在西班牙的商業化上市仍處於早期階段。我們正在法國和義大利就定價和報銷事宜進行磋商，目標是在年底前完成。

Guidelines historically have had a significant impact on prescribing patents. Genvoya is already listed with the preferred regimen in several HIV treatment guidelines, including the European AIDS Clinical Society as well as country guidelines in Germany, the UK, Spain and Italy.

指引歷來對處方患者產生重大影響。 Genvoya 已被列入多項 HIV 治療指南的首選方案，包括歐洲愛滋病臨床學會指南以及德國、英國、西班牙和義大利等國的國家指南。

I would like to make a few comments about HIV prevention and the use of Truvada for PrEP. The growth in people starting Truvada points to the valuable role that therapy can play when used as part of the comprehensive strategy to prevent transmission. We estimate that in the US approximately 80,000 to 90,000 people were using Truvada for this indication in the third quarter.

我想就愛滋病預防和使用Truvada進行暴露前預防（PrEP）談幾點看法。開始服用Truvada的人數不斷增長，顯示這種療法在預防傳播的綜合策略中發揮著重要作用。我們估計，第三季美國約有8萬至9萬人因該適應症使用Truvada。

We are also starting to see usage of PrEP France, where approximately 2,000 people have begun -- have been prescribed Truvada since it received reimbursements in January of this year. We expect PrEP to continue to be a significant part of Gilead's growth in HIV going forward, particularly in the US. With the rapid adoption of TAF-based regimens, the potential of PrEP and our exciting pipeline programs, especially bictegravir, I'm very positive about the long-term lifecycle potential we have in HIV.

我們也開始看到 PrEP 在法國的使用情況，自今年 1 月 Truvada 獲得健保報銷以來，已有約 2,000 人開始服用。我們預計 PrEP 將繼續成為吉利德 HIV 業務成長的重要組成部分，尤其是在美國。隨著 TAF 為基礎的治療方案的快速普及、PrEP 的潛力以及我們令人振奮的在研計畫（特別是比克替拉韋），我對我們在 HIV 領域的長期發展前景非常樂觀。

Turning to HCV, approximately 61,000 people in total began HCV therapy in the US in the third quarter of 2016. This represents the fourth consecutive three-month period where patient starts have been in the 50,000 to 60,000 range. We estimate that more than 85% of treated patients in the most recent quarter received a sofosbuvir-based regimen.

就C型肝炎而言，2016年第三季美國共有約61,000人開始接受C型肝炎治療。這是連續第四個季度新增患者人數在50,000至60,000人之間。我們估計，最近一個季度接受治療的患者中，超過85%的人接受了以索非布韋為基礎的治療方案。

The uptick of Epclusa has been most encouraging in its first full quarter post launch. Although it is important to point out that we have observed a small, yet noticeable warehousing effect. As expected, the vast majority of Epclusa is being used in genotype 2 and 3 patients according to our 12-week label. In terms of payer coverage, formulary reviews for Eplcusa are on track. 11 state Medicaid programs have already added Epclusa for genotype 2 and 3 patients and most commercial and Medicare part D plans are providing insurance coverage for Epclusa based on medical need. Finally, the VA has added Epclusa to their national formulary and have begun ordering.

Epclusa上市後的第一個完整季度銷售成長令人鼓舞。不過，值得注意的是，我們也觀察到了輕微但明顯的庫存積壓效應。如預期，根據我們12週的說明書，Epclusa的大部分用於基因型2和3的患者。在健保覆蓋方面，Epclusa的處方集審查進展順利。已有11個州的醫療補助計劃將Epclusa納入基因型2和3患者的醫保範圍，大多數商業保險和聯邦醫療保險D部分計劃也根據醫療需求為Epclusa提供保險。最後，美國退伍軍人事務部已將Epclusa納入其國家處方集並開始訂購。

The 2017 commercial and Medicare part D contracting cycle is now essentially complete. And whilst I cannot share with you plan-by-plan details, suffice to say that we are pleased with the picture for the coming year. Discussions with all major the PBMs and MCOs prove to be productive and recognize the clinical leadership of Gilead's HCV options, especially as demonstrated in real-life settings. But barriers to access still remain. As Medicaid continues to be the outlier in terms of access, restricting coverage to only the more advanced patients.

2017 年商業保險和聯邦醫療保險 D 部分 (Medicare Part D) 的合約簽訂週期已基本完成。雖然我無法逐一透露具體計劃的細節，但可以說我們對來年的前景感到滿意。與所有主要藥品福利管理機構 (PBM) 和管理式醫療機構 (MCO) 的討論都卓有成效，並認可了吉利德丙型肝炎治療方案的臨床領先地位，尤其是在實際應用中展現出的療效。然而，獲取治療仍存在障礙。醫療補助計劃 (Medicaid) 在覆蓋範圍方面仍然是一個例外，它僅限於病情較重的患者。

Turning to Europe, total HCV revenue in the third quarter was $604 million, down 30% year-over-year and down 22% sequentially. This was driven by lower HCV patient starts. While overall patient starts declined, our market share remains largely unchanged across the major markets with the exception of the UK, which was slightly down for the quarter.

轉至歐洲市場，第三季丙型肝炎業務總營收為6.04億美元，較去年同期下降30%，季減22%。這主要是由於丙型肝炎新發患者數量減少所致。儘管新發患者總數有所下降，但除英國市場外，我們在主要市場的市場份額基本保持不變，英國市場的份額在本季度略有下降。

We estimate that 21,000 patients started on a sofosbuvir-based regimen in the third quarter compared to 27,000 in the second quarter. At our last earnings I described how we were observing lower patient starts in the early EU launch markets of Germany and France. Put simply, many of the high need patients have been treated and cured. We are now starting to see this trend unfold in Southern European countries, particularly in Italy and in Spain.

我們估計，第三季有21,000名患者開始接受索非布韋治療方案，而第二季度為27,000名。在上次財報發表會上，我曾提到，我們在德國和法國這兩個歐盟早期上市市場觀察到病患起始治療人數下降。簡而言之，許多急需治療的患者已經得到治療並治癒。現在，我們開始看到這種趨勢在南歐國家出現，尤其是在義大利和西班牙。

Performance in the region is also likely somewhat affected by summer seasonality, similar to the dynamics we observed in HIV. Epclusa is now being launched in Germany, Sweden, Norway, Finland and Denmark. I am pleased to say that there have been the same positive receptions as in the US. We expect to launch in the other large EU markets once pricing and reimbursement is in place by the second half of 2017. Not only just 12 weeks of Epclusa deliver incredibly high cure rates, but as the new standard of care, it is considerably cheaper than previously used interferon free regimens, especially treating genotype 3.

該地區的療效可能也受到夏季季節性因素的影響，這與我們觀察到的愛滋病毒感染情況類似。 Epclusa 目前已在德國、瑞典、挪威、芬蘭和丹麥上市。我很高興地告訴大家，這些市場反應與美國市場一樣正面。我們預計，一旦定價和報銷機制在 2017 年下半年到位，我們將在其他歐盟主要市場推出產品。 Epclusa 僅需 12 週即可達到極高的治癒率，而且作為新的標準療法，其價格遠低於以往使用的無幹擾素療法，尤其是在治療基因 3 型愛滋病毒感染方面。

As I conclude my remarks on hepatitis C, it is very important to reiterate that more work needs to be done to identify and cured HCV infected people around the globe. A key objective for Gilead is to appropriately raise disease awareness, highlight the importance of age-related testing and encourage linkage to specialty care.

在我結束關於丙型肝炎的發言之前，我必須重申，我們需要在全球範圍內開展更多工作，以識別和治癒丙型肝炎病毒感染者。吉利德公司的一項關鍵目標是適當提高大眾對C型肝炎的認識，強調與年齡相關的檢測的重要性，並鼓勵患者接受專科治療。

To help with this effort we recently launched new educational campaigns in the US and Japan to urge all individuals at risk for or living with HCV to talk to their health care provider. You may have seen our new advertisement on television here in the US. It debuted last week and I am very pleased with the positive and responsible tone it takes to emphasize to people the need to be screened for a disease that can now be cured in as little as 8 weeks. We have received numerous, positive comments from advocacy groups, providers and, not least, the many people already cured of hepatitis C who want others like them to benefit.

為了幫助這項工作，我們近期在美國和日本啟動了新的教育宣傳活動，敦促所有有感染丙型肝炎風險或已感染丙型肝炎的人士與他們的醫療保健提供者溝通。您可能已經在美國的電視上看到了我們的新廣告。該廣告上週首播，我非常欣慰地看到它以積極負責的語氣強調了篩檢這種疾病的必要性，因為這種疾病現在最快可以在8週內治愈。我們收到了來自倡導團體、醫療服務提供者以及許多已治癒丙型肝炎患者的正面回饋，他們希望其他和他們一樣的人也能從中受益。

Moving on, one of the liver diseases that warrants some mentioning today is hepatitis B, for which we are well prepared for the launch of TAF. With our PDUFA date coming up, we are hopeful that we will have the opportunity to speak to physicians at the AASLD meeting and in the field about the strong data for this product as soon as next week.

接下來，今天值得一提的肝臟疾病之一是乙型肝炎，我們已為TAF的上市做好了充分準備。隨著PDUFA審批日期的臨近，我們希望最早下週就能在AASLD年會上以及與第一線醫生交流，介紹該產品的強有力數據。

Finally, as I highlighted last quarter, we have a very strong US cardiovascular team that continues to deliver impressive results. The Terisa and Ranexa revenue totaled $385 million for the quarter and surpassed $1 billion in the year-to-date.

最後，正如我上個季度重點提到的，我們擁有一支實力雄厚的美國心血管團隊，他們持續取得令人矚目的業績。 Terisa 和 Ranexa 本季總收入達 3.85 億美元，年初至今累計收入已超過 10 億美元。

In closing, I would like to reiterate the positive progress Gilead is making in addressing viral diseases. We will soon have treated 1.2 million HCV infected individuals around the world, most of whom are now cured. By any measure, this is a profound contribution to global healthcare delivery.

最後，我想重申吉利德在應對病毒性疾病方面取得的積極進展。我們即將為全球120萬丙型肝炎病毒感染者提供治療，其中大多數患者現已治癒。無論從哪個角度來看，這都是對全球醫療保健事業的重大貢獻。

And in the field of HIV, not only are we effectively managing the disease with our new TAF-based regimens but Truvada is helping more and more people avoid infection. I am confident that we will close out the year and continued strong financial performance, underpinned by a passion for operational excellence and our focus on putting the patient first.

在愛滋病領域，我們不僅透過基於TAF的新型治療方案有效控制了病情，而且Truvada正在幫助越來越多的人避免感染。我相信，憑藉對卓越營運的執著追求和以患者為中心的理念，我們將以強勁的財務業績結束今年。

I will now hand the call over to Norbert.

現在我將把電話交給諾伯特。

Thank you, Kevin.

謝謝你，凱文。

During the third quarter a number of phase 2 and phase 3 studies concluded, providing insight into efficacy and safety of both the proof and experimental Gilead agents in the areas of HIV, liver disease, inflammation, oncology and cardiovascular disease. Some of these results were disappointment, some were exciting successes. To start off with the disappointment, we now have the final analyses from three 96-week studies of the anti-loxl-2 monoclonal antibody, Simtuzumab.

第三季度，多項二期和第三期臨床試驗完成，為吉利德公司在愛滋病、肝病、發炎、腫瘤和心血管疾病領域已驗證和試驗性藥物的療效和安全性提供了重要資訊。其中一些結果令人失望，有些則令人振奮。首先說說令人失望的結果，我們現在獲得了抗loxl-2單株抗體Simtuzumab三項為期96週研究的最終分析結果。

The data indicate that while safe and well tolerated, there is no evidence of efficacy in one study in Primary Sclerosing Cholangitis and in two studies in NASH. One NASH study was in patients with cirrhosis and one was in patients with branching fibrosis. Consequently, we will not develop Simtuzumab any further in these or any other indications. We will present this data at future conferences.

數據顯示，雖然西妥珠單抗安全性良好且耐受性良好，但在一項原發性硬化性膽管炎研究和兩項非酒精性脂肪性肝炎（NASH）研究中均未發現療效證據。其中一項NASH研究納入了肝硬化患者，另一項研究納入了分支纖維化患者。因此，我們將不再針對這些或其他適應症進一步開發西妥珠單抗。我們將在未來的會議上公佈這些數據。

As for GS-5745, an anti-MMP9 antibody, we stopped the phase 2, 3 study in patients with ulcerative colitis because of the lack of efficacy. This decision followed a planned interim DSMB analysis after the first 150 patients had been enrolled that the study met predefined futility criteria.

至於抗MMP9抗體GS-5745，由於療效不佳，我們終止了其在潰瘍性結腸炎患者的II期和III期研究。此前，在首批150名患者入組後，資料安全監察委員會（DSMB）進行了一次計劃中的中期分析，結果顯示該研究符合預先設定的無效標準。

Also, and not unexpectedly, there was no evidence of benefitGS-5745 in a phase 2 study in patients with Crohn's disease. Consequently, we will not further pursue GS-5745 for ulcerative colitis or Crohn's. In these studies, GS-5745 was safe and well-tolerated and we're continuing to evaluate GS-5745 in rheumatoid arthritis as an add-on to anti-TNFs or other therapies.

此外，不出所料，在克隆氏症患者的第二期研究中，GS-5745 並未顯示出療效。因此，我們將不再繼續開發 GS-5745 用於治療潰瘍性結腸炎或克隆氏症。在這些研究中，GS-5745 安全且耐受性良好，我們正在繼續評估 GS-5745 作為抗 TNF 或其他療法的輔助治療用於治療類風濕性關節炎的療效。

Eleclazine, or GS-6615 failed to meet its primary endpoint in the study of patients with ventricular tachycardia, ventricular fibrillation or VTVF and implanted cardioverter defibrillators. Patients were randomized to do two doses of Eleclazine or placebo. The primary endpoint was the number of electrical interventions, including shocks and pacing by the implanted device and there was no evidence of efficacy of Eleclazine compared to placebo. Consequently, we will not develop Eleclazine any further for VTVF evaluation in the Long QT-3 Syndrome and in Hypertrophic Cardiomyopathy is continue.

在針對植入式心臟復律去顫器（ICD）的室性心動過速、室顫或室性心動過速-室顫（VTVF）患者的研究中，Eleclazine（GS-6615）未能達到其主要終點。患者被隨機分配接受兩劑Eleclazine或安慰劑。主要終點是植入裝置進行的電刺激次數，包括電擊和起搏，結果顯示Eleclazine與安慰劑相比沒有療效。因此，我們將不再繼續開發Eleclazine用於長QT-3症候群和肥厚型心肌病變患者的VTVF評估。

But now to the excitement, starting with HCV, the pangenotypic single pill in triple combination regimen of Sofosbuvir, Velpatasvir and Voxilaprevirthe, or I'll call it Sof/Vel/Vox has been studied in four phase 3 studies called polaris 1, 2, 3 and 4. Polaris 1 and 4 evaluated the regimen in patients who had previously failed a direct acting antiviral and included patients with cirrhosis. Treatment of the salvage patients with Sof/Vel/Vox resulted in SVR rates of 96% and 97%.

現在來說說令人興奮的部分，首先是丙型肝炎病毒（HCV）的治療。索非布韋、維帕他韋和伏西瑞韋（簡稱Sof/Vel/Vox）的三聯療法是一種泛基因型單片複方製劑，已在四項名為Polaris 1、2、3和4的3期臨床試驗中進行了研究。 Polaris 1和4評估了該方案在先前直接抗病毒藥物治療失敗的患者中的療效，其中包括肝硬化患者。 Sof/Vel/Vox方案治療挽救性患者的持續病毒學反應率（SVR）分別為96%和97%。

The two other studies, polaris 2 and 3 compared to triple combination regimen in treatment-naive patients given for 8 weeks to Epclusa given for 12 weeks. Polaris 2 was open to all genotypes where polaris 3 enrolled only genotype 3-infected individuals with compensated cirrhosis where the unmet need is the greatest. In polaris 2 the SVR rates of pain with 12 weeks of Epclusa where numerically higher than those of pain with 8 weeks of the triple combination, whereas in polaris 3 the SVR rates were comparable.

另外兩項研究，Polaris 2 和 Polaris 3，比較了初治患者接受 8 週三聯合療法和 12 週 Epclusa 治療的效果。 Polaris 2 納入了所有基因型，而 Polaris 3 僅納入了基因 3 型感染且處於代償期肝硬化的患者，因為這類患者的未滿足需求最大。在 Polaris 2 中，接受 12 週 Epclusa 治療的疼痛持續病毒學反應率 (SVR) 高於接受 8 週三聯療法的疼痛持續病毒學反應率，而在 Polaris 3 中，兩種療法的 SVR 率相當。

Particularly in polaris 3, which involved the most difficult to treat genotype 3 infected cirrhotic patients, Epclusa for 12 weeks resulted in 96% SVR rates. These results underscore the value of Epclusa as an excellent treatment option for patients across all genotypes and they also suggest that the future role of Sof/Vel/Vox will be for patients who previously failed an antiviral regimen. The full data for these studies will be presented ASLD in a few weeks and we will submit marketing authorization applications to regulatory authorities imminently.

尤其是在 Polaris 3 研究中，該研究納入了最難治療的基因 3 型感染肝硬化患者，Epclusa 治療 12 週後，持續病毒學反應率 (SVR) 達到了 96%。這些結果凸顯了 Epclusa 作為所有基因型患者的理想治療選擇的價值，同時也表明 Sof/Vel/Vox 未來可能更適用於既往抗病毒治療失敗的患者。這些研究的完整數據將在幾週後提交給 ASLD，我們將盡快向監管機構提交上市許可申請。

Another exciting result was the anti-fibrotic effect observed with GS-4997, an investigational small molecule inhibitor of apoptosis signal-regulating kinase 1 or ASK-1. GS-4997 was shown to inhibit inflammation apoptosis and fibrosis in settings of increased oxidative stress associated with NASH in pre-clinical models.

另一個令人興奮的結果是，GS-4997（一種正在研究的小分子凋亡訊號調節激酶 1 或 ASK-1 抑制劑）表現出抗纖維化作用。在臨床前模型中，GS-4997 已被證明能夠抑制與 NASH 相關的氧化壓力增加情況下的發炎、細胞凋亡和纖維化。

This phase 2 clinical study involved 72 patients, two-thirds had F3 stage fibrosis and one-third had F2 stage fibrosis. There was evidence that treatment of GS-4997 for only 24 weeks resulted in fibrosis reversal and decreased fibrosis progression in a dose-dependent manner. At the highest dose tested, which was 18mg, 43% of patients showed at least a one point decrease in their fibrosis score compared to only 20% in the Simtuzumab controller. At the same time, 20% of the Simtuzumab-treated patients progressed to cirrhosis compared to only 3%, or 1 out of 30, at the 18mg dose.

這項 II 期臨床研究納入了 72 例患者，其中三分之二為 F3 期纖維化，三分之一為 F2 期纖維化。結果表明，僅需 24 週的 GS-4997 治療即可逆轉纖維化，並以劑量依賴的方式減緩纖維化進展。在最高測試劑量 18 mg 下，43% 的患者纖維化評分至少下降 1 分，而 Simtuzumab 對照組僅為 20%。同時，Simtuzumab 治療組中有 20% 的患者進展為肝硬化，而 18 mg 劑量組的進展率僅為 3%（即 30 例患者中僅有 1 例）。

The full data from these studies will be presented at ASLD in a few weeks. Based on these exciting data, we will initiate discussions with regulatory authorities and plan to move GS-4997 into phase 3 clinical development in patients with NASH. Based on the phase 2 results, we intend to evaluate GS-4997 in patients with the highest unmet need. That means those with F3 and F4 stages of fibrosis.

這些研究的完整數據將在幾週後的ASLD會議上公佈。基於這些令人振奮的數據，我們將與監管機構展開討論，並計劃將GS-4997推進至NASH患者的III期臨床開發階段。根據II期臨床試驗的結果，我們計劃在醫療需求未滿足的患者群體中評估GS-4997的療效，這些患者屬於F3和F4期纖維化階段。

At the same time, we have two other compounds with different mechanisms currently in two phase 2 studies in patients with NASH and fibrosis and that is GS-9674, an FXR agonist, and GS-0976, an ACC inhibitor. And these studies are 24 and 12 weeks duration respectively. Pending demonstration of single agent efficacy and safety in these phase 2 studies, we plan to initiate combination studies with the three agents toward the middle of next year.

同時，我們還有兩種作用機轉不同的化合物目前正在針對非酒精性脂肪性肝炎（NASH）合併纖維化患者進行兩項II期臨床試驗，它們分別是FXR激動劑GS-9674和ACC抑制劑GS-0976。這兩項試驗的持續時間分別為24週和12週。待這兩項II期臨床試驗證實單藥療效和安全性後，我們計劃於明年年中啟動這三種藥物的合併用藥研究。

In HIV we are continuing to explore the utility of TAF containing regimens in various uses in different populations. Last week, data from three phase 3 studies were presented at the HIV conference in Glasgow. 96-week data were disclosed from one study where 663 virologically-suppressed patients were randomized to either continue under the Truvada-based regimens or to switch to a Descovy-based regimens.

在愛滋病治療領域，我們持續探索含TAF方案在不同族群中的應用價值。上週，在格拉斯哥舉行的愛滋病大會上公佈了三項3期臨床試驗的數據。其中一項研究揭露了為期96週的數據，該研究將663名病毒學抑制的患者隨機分為兩組，一組繼續接受基於Truvada的治療方案，另一組則轉為基於Descovy的治療方案。

In two other studies, 630 or 875 virologically-suppressed patients on Complera and datripler respectively were randomized to switch to Odefsey or stay on their current regimen. In all studies, switching to a TAF-based regimen was none inferior with regards to efficacy, but was superior with regards to renal and bone laboratory safety parameters.

在另外兩項研究中，分別有 630 例和 875 例病毒學抑制的患者接受了 Complera 和 datripler 治療，並被隨機分配到 Odefsey 組或繼續使用現有治療方案組。所有研究均表明，改用基於 TAF 的治療方案在療效方面不遜於現有方案，但在腎臟和骨骼實驗室安全性指標方面更優。

The phase 3 development of the single tablet regimen of Bictegravir/F/TAF is continuing. Four phase 3 studies are now fully enrolled and we anticipate unblinding these studies towards the middle of next year with regulatory submissions planned for the third quarter of 2017. We also plan to present 48 week phase 2 data on Bictegravir/F/TAF at the scientific meeting in the first quarter of 2017. In oncology the phase 3 study of GS-5745 in patients with gastric cancer is ongoing, as well as a phase 2 study in patients with gastric cancer in combination with nivolumab. We are also evaluating GS-5745 in other solid tumors.

比克替拉韋/F/TAF單片製劑的III期臨床試驗正在進行中。目前已有四項III期臨床試驗完成全部受試者招募，預計明年年中揭盲，併計劃於2017年第三季提交監管申請。我們也計劃在2017年第一季的科學會議上公佈比克替拉韋/F/TAF的48週II期臨床試驗數據。在腫瘤領域，GS-5745治療胃癌患者的III期臨床試驗正在進行中，同時，GS-5745合併納武利尤單抗治療胃癌患者的II期臨床試驗也正在進行中。此外，我們也正在評估GS-5745在其他實體腫瘤的療效。

In addition, we have now completed two phase 1 safety studies of our combination kinase inhibitors. We were able to establish safe doses of our PI3K inhibitor, Idelalisib, in combination with our BTK inhibitor GS-4059 and our Syk inhibitor, Entospletinib, in combination the BTK inhibitor GS-4059. Consequently, we will now first evaluate the PI3K/BTK combination with and without anti-CD20 therapy in relapsed refractory CLL patients in collaboration with the German CLL study group.

此外，我們已完成兩項激酶抑制劑合併用藥的I期安全性研究。我們確定了PI3K抑制劑Idelalisib與BTK抑制劑GS-4059合併用藥以及Syk抑制劑Entospletinib與BTK抑制劑GS-4059合併用藥的安全劑量。因此，我們將先與德國CLL研究小組合作，評估PI3K/BTK合併用藥合併或不合併抗CD20療法治療復發難治性CLL患者的療效。

We will also be announcing the initial phase 1 B2 data on our Syk inhibitor Entospletinib, an acute myeloid leukemia, at the upcoming ASH conference in San Diego. We have entered into a collaboration with the Leukemia Lymphoma Society to provide Entospletinib for their beat AML master trial. This trial will employ the latest genomic technology to match specific AML mutations in newly diagnosed patients over age of 60 with an appropriate investigational drug or drug combination.

我們將在即將於聖地牙哥舉行的美國血液學會（ASH）年會上公佈其Syk抑制劑Entospletinib（一種治療急性骨髓性白血病的藥物）的初步I期B2數據。我們已與白血病淋巴瘤協會（LLS）達成合作，為其beat AML主試驗提供Entospletinib。本試驗將採用最新的基因組學技術，為60歲以上新診斷的AML患者配對特定的突變基因，並為其選擇合適的試驗藥物或藥物組合。

In summary, great progress has been made with some of our programs. The very nature of R&D is that you often face both closures and progress. Going forward, I am pleased we now have the ability to focus our attention on development programs in NASH, inflammation, oncology and HIV. We now have seven new molecules in advanced clinical development. The PDUFA date for TAF for HPV is coming up in a few weeks and we plan to file an NDA before the end of the year on Sof/Vel/Vox for use as salvage therapy for patients who have failed a previous direct acting ant-viral.

總而言之，我們的一些專案取得了顯著進展。研發的本質就在於，我們常常會面臨專案終止和取得進展的雙重挑戰。展望未來，我很高興我們現在能夠將精力集中在非酒精性脂肪性肝炎（NASH）、發炎、腫瘤和愛滋病（HIV）領域的研發項目上。目前我們有七個新分子處於後期臨床開發階段。用於治療人類乳突病毒（HPV）的TAF的處方藥用戶付費法案（PDUFA）審批日期將在幾週後到來，我們計劃在年底前提交Sof/Vel/Vox的新藥申請（NDA），用於治療先前直接抗病毒藥物治療失敗的患者的挽救性治療。

Four molecules are continuing in phase 3. That is Momelotinib for myelofibrosis, bictegravir F-TAF, the single tablet regimen for HIV infection, Filgotinib for three separate indication, rheumatoid arthritis, ulcerative colitis and Crohn's and GS-5745 in gastric cancer. Finally, we plan to advance GS-4997 for NASH to phase 3.

目前有四種分子藥物正在進行第三期臨床試驗。它們分別是：用於治療骨髓纖維化的Momelotinib、用於治療HIV感染的單片複方製劑bictegravir F-TAF、用於治療類風濕性關節炎、潰瘍性結腸炎和克隆氏症這三種不同適應症的Filgotinib，以及用於治療胃癌的GS-5745。此外，我們計劃將用於治療非酒精性脂肪性肝炎（NASH）的GS-4997推進至第三期臨床試驗。

I would now like to turn over -- to call over to John.

現在我想把鏡頭切換到約翰。

Thanks, Norbert.

謝謝你，諾伯特。

I would like to make a few closing remarks before we get to your questions. We continue to have success with the important work we do in HIV and viral hepatitis. There is still a great need for innovation in these fields. Both of diseases include patients whose needs remain unaddressed and both represent global epidemics.

在回答各位的問題之前，我想做幾點總結。我們在愛滋病和病毒性肝炎領域的重要工作持續取得成功。但這些領域仍然迫切需要創新。這兩種疾病都存在大量患者需求未被滿足的情況，而且都屬於全球性流行病。

Our researchers are working to bring new options to a wider range of patients than ever before. This includes people with HIV who have been on therapy for decades and may need to change their medication due to side effects, or patients who may be failing to fully suppressor their virus due to the presence resistant.

我們的研究人員正致力於為比以往任何時候都更廣泛的患者群體提供新的治療選擇。這包括已接受數十年治療、可能因副作用而需要更換藥物的愛滋病毒感染者，以及因存在抗藥性而無法完全抑制病毒的患者。

Approaches our research teams are pursuing include new molecules for trading resistant virus, novel formulations and combinations that may be dosed infrequently and opportunities to cure HIV patients by clearing out the viral reservoir from their bodies. Our innovative work, in conjunction with our many partners, has already allowed our HIV medicines to reach millions of patients worldwide.

我們的研究團隊正在探索的途徑包括：研發對抗抗藥性病毒的新分子、開發可減少給藥頻率的新型製劑和組合療法，以及透過清除體內病毒庫來治癒愛滋病患者。我們與眾多合作夥伴攜手進行的創新工作，已使我們的愛滋病藥物惠及全球數百萬患者。

We're particularly excited about the roll that TAF will play. With a small daily dose and a proved side effect profile, it is ideal for resource constrained areas of the world and requires only 1/10 of the manufacturing capacity to supply the same number of patients. In the area of viral hepatitis, the data now obtained with Epclusa suggests that we have an excellent option for the many parts of the developing world for genotyping HCV and determine the stage of disease can be difficult, if not impossible. With Epclusa, there's no difference in dosing for the different genotypes or stages of liver disease. And so there is no need for these diagnostic procedures. We are working around the globe to rapidly introduce Epclusa, as well as Sovaldi and Harvoni.

我們對TAF將發揮的作用感到特別興奮。 TAF每日劑量小，副作用也已得到證實，因此非常適合資源匱乏的地區，而且只需十分之一的生產能力即可滿足相同數量患者的需求。在病毒性肝炎領域，目前Epclusa獲得的數據表明，對於許多發展中國家而言，我們擁有一個極佳的選擇，可以進行HCV基因分型，並確定疾病的階段。在這些地區，要確定疾病階段可能非常困難，甚至不可能。而Epclusa對不同基因型或肝病階段的劑量沒有區別，因此無需進行這些診斷程序。我們正在全球範圍內努力，以快速推廣Epclusa以及Sovaldi和Harvoni。

Finally, in hepatitis B, as Kevin and Norbert mentioned, we are approaching the launch of TAF. HPV continues to be an under-treated disease, despite the long-term data showing improvement of liver for people who remain on affective therapy. TAF provides an important new option for patients with chronic HPV and we will have the opportunity to enter to the product at deliver meeting in the next coming weeks in Boston. We also recognize that treating such a prevalent disease chronically is a major global challenge and we continue to seek ways to provide finite duration of treatment that the patients can control or eliminate the virus without having to endure a lifetime of treatment. Gilead's largest research effort is in the area of HPV cure.

最後，正如凱文和諾伯特所提到的，在B型肝炎方面，我們即將推出TAF。儘管長期數據顯示，接受有效治療的患者肝臟狀況有所改善，但HPV感染仍然是一種治療不足的疾病。 TAF為慢性HPV感染患者提供了一個重要的全新選擇，我們將在未來幾週於波士頓舉行的交付會議上有機會正式推出該產品。我們也意識到，長期治療這種高發生疾病是一項重大的全球性挑戰，我們將繼續尋求提供有限療程的治療方案，使患者能夠在無需終身治療的情況下控製或清除病毒。吉利德目前最大的研究方向是HPV治癒。

Beyond our work in antivirals, we're making great progress in new disease areas for Gilead. We are pleased to be able to share with you today our top line data for GS-4997 and NASH. GS-4997 targets ASK-1, a previously unexplored target for NASH. The data are very suggestive of a strong anti-fibrotic activity after only a 24-week period of treatment and we look forward to future in-depth discussions once the data are presented at ASLD.

除了抗病毒藥物領域的研究之外，吉利德在其他疾病領域也取得了顯著進展。今天，我們很高興與大家分享GS-4997治療非酒精性脂肪性肝炎（NASH）的初步數據。 GS-4997標靶ASK-1，這是NASH領域一個先前未被探索的標靶。數據顯示，光是24週的治療，GS-4997就展現出強大的抗纖維化活性。我們期待在ASLD年會上公佈這些數據後，與大家進行更深入的探討。

We think about GS-4997 as a potential backbone molecule, one that can be used alone or in combination. NASH is an understudied but increasingly prevalent disease and Gilead's liver disease team has now has three exciting molecules to move forward into clinical studies.

我們認為GS-4997是一種潛在的骨架分子，可以單獨使用，也可以與其他藥物合併使用。非酒精性脂肪性肝炎（NASH）是一種研究不足但日益普遍的疾病，吉利德的肝病團隊目前已有三種令人振奮的分子即將進入臨床研究階段。

We understand that there's a lot of work to do in providing both the rational to the patient and to the payer as to the benefits of treating NASH. An active compound such as GS-4997 could really move this field forward and we are in the process of designing comprehensive studies to demonstrate the health system benefits of treating such a prevalent and growing disease.

我們明白，要讓患者和支付者都充分理解治療非酒精性脂肪性肝炎（NASH）的益處，還有很多工作要做。像GS-4997這樣的活性化合物有望真正推動這一領域的發展，我們正在設計全面的研究，以證明治療這種日益普遍且不斷增長的疾病對醫療系統的益處。

In the area of inflammation, we are executing nicely on our development plan. Phase 3 studies of Filgotinib in RA are up and running and studies in Crohn's and ulcerative colitis have just begun screening patients in the first of the studies. I am pleased with the progress we are making and the work of our teams of collaborators to get these trials up and running as quickly as possible. We are also looking forward to exploratory studies of Filgotinib in a wider variety of inflammatory diseases so we can fully understand the potential of this specific JAK1 inhibitor.

在發炎領域，我們的研發計畫進展順利。 Filgotinib治療類風濕性關節炎的3期臨床試驗已經啟動，而針對克隆氏症和潰瘍性結腸炎的臨床試驗也已開始進行患者篩選。我對我們所取得的進展以及合作團隊為盡快啟動這些試驗所做的努力感到非常滿意。我們也期待進行Filgotinib在更多發炎性疾病的探索性研究，以便充分了解這種JAK1抑制劑的潛力。

As you know, we are also focused on augmenting our portfolio with external opportunities, particularly in the field of oncology. However, our interest in partnerships and potential acquisitions is not limited to oncology and we are considering opportunities for a strong science and will receive the possibilities to developing a truly differentiated product. We have been going through an extensive internal review of programs and opportunities and an important aspect of our approach is that we remain open-minded but disciplined. So while we have the balance sheet to execute on multiple opportunities, we will keep the bar high.

如您所知，我們正致力於透過外部機會拓展產品組合，尤其是在腫瘤領域。然而，我們對合作和潛在收購的興趣並不局限於腫瘤領域，我們也在考慮其他具有強大科學研究實力、能夠開發真正差異化產品的機會。我們一直在對各項計劃和機會進行廣泛的內部評估，我們方法的一個重要方面是保持開放的心態，同時又嚴謹自律。因此，儘管我們擁有足夠的資金來把握多個機會，但我們將始終堅持高標準。

With two months of the year remaining, I want to take the opportunity to thank the 9,000 employees of Gilead for their hard work and dedication. Every day, more than 10 million individuals around the world are taking Gilead medication and every day our teams come to work to improve upon that number.

今年還有兩個月，我想藉此機會感謝吉利德的9000名員工的辛勤工作和奉獻精神。每天，全球有超過1000萬人服用吉利德的藥物，而我們的團隊每天都在努力工作，力求讓這個數字不斷成長。

Thank you for your time and let's now open the call to questions. Operator?

感謝您抽出時間，現在我們開始回答問題。接線生？

(Operator Instructions)

（操作說明）

Our first question comes from the line of Geoff Meacham from Barclays. Your line is now open.

我們的第一個問題來自巴克萊銀行的傑夫·米查姆。您的提問通道現已開放。

Hi, guys. Good afternoon and thanks for taking the question. John or Kevin, I got one for you. Just I want to ask about hep C but in a broader context. You guys have had flat patient numbers despite better access in the US and revenues down sequentially but on payer mix. So the question is, how do you think about the return on investing continually in hep C either commercially or in new products versus say looking outwards and being more aggressive in a new therapeutic category? Thanks.

大家好，下午好，感謝你們回答問題。約翰或凱文，我有個問題想問你們。我想問的是C肝方面的問題，但想從更廣泛的角度來探討。儘管在美國市場，C肝的可近性有所提高，但你們的患者數量卻一直保持穩定，收入也較上季下降，不過這與支付方結構有關。所以我的問題是，你們如何看待持續投資丙型肝炎（無論是商業開發還是新產品研發）的回報，與將目光投向其他領域，積極開拓新的治療領域相比，哪種方式更有吸引力？謝謝。

Hi, Geoff. It's Kevin. Let me take maybe half a step back from your question just a few moral reservations. I got to tell you that I think we are really executing well in the area of hepatitis C. I have spent a lot of time this quarter with many Gileads and with several providers. And I think the variables that we can directly influence, we're really doing a good job on. Our market share is staying incredibly strong. We are ensuring access while preserving the value of our hepatitis C drugs. We are executing on new versions coming to the market. I think you have seen that with Epclusa.

嗨，傑夫。我是凱文。我想先稍微退一步，談談我的看法。我必須告訴你，我認為我們在丙型肝炎領域做得非常出色。這個季度我花了很多時間和吉利德的許多員工以及幾家醫療機構的同事交流。我認為，在我們能夠直接控制的範圍內，我們做得非常好。我們的市佔率保持得非常強勁。我們既確保了藥物的可近性，也保證了C型肝炎藥物的價值。我們正在推動新版本的上市。我想你已經從Epclusa的案例中看到了這一點。

And the area that we can less control but we can influence, you are now seeing some new activities from us in terms of unbranded awareness campaigns. And you may have seen our advertisement that came on the television just over a week ago. So I think, from my point of view, in terms of operation excellence, we are doing a very nice job.

而對於我們控制力較弱但影響力可控的領域，您現在可以看到我們進行了一些新的活動，例如非品牌宣傳活動。您可能也看到了我們一週前在電視上投放的廣告。所以，我認為，就卓越營運而言，我們做得非常出色。

It is true that the treatments are staying about the same. Actually, I consider that very positive. Let's not forget that we are at treatment levels that are 2.5 times the treatment levels that were there before the Gilead regimens came to the market. So I take at the level of 50,000 to 60,000 patients is very good. The vast proportion of those are Gilead patients. Epclusa had a very big effect in this quarter. So it goes to show that there's still room for new patients, albeit we're entering a high level of satisfaction. But with Harvoni, [petuia] type I -- both 12 weeks and now a high proportion at 8 weeks and now Epclusa for the two and three patients, yes.

治療方案確實基本上維持不變。實際上，我認為這非常積極。別忘了，我們現在的治療量是吉利德方案上市前的2.5倍。所以我認為5萬到6萬名患者的規模非常可觀。其中絕大多數是吉利德的患者。 Epclusa在本季度取得了顯著成效。這表明，儘管患者滿意度已經很高，但仍有新增患者的需求。 Harvoni（治療12週）和現在8週時就達到較高比例的患者都取得了成功，Epclusa也適用於二至三週的患者。

We have got patients being cured at very high levels. In terms of our triple, I do agree that it will be a relatively small proportion of patients, but it is the right thing to do and it completes our whole picture for hepatitis C. So I think to have the range of products that we have, to have the efficacy that we have is the right offering for healthcare. So we continue to move forward. And I think we have a healthy franchise and we are getting better access from particularly the commercial pairs. Although, as I pointed out -- and I often discuss with the team, here -- the Medicaid is still a little bit on the slow side in terms of access. But great progress as far as I am concerned in the third quarter.

我們治癒的患者比例非常高。就我們的三重療法而言，我同意它只會惠及相對較小比例的患者，但這是正確的做法，它完善了我們對丙型肝炎的整體治療方案。因此，我認為我們擁有的產品系列和療效對於醫療保健來說是正確的選擇。所以我們繼續前進。我認為我們擁有健康的市場地位，我們正在透過商業管道獲得更好的市場准入。儘管正如我指出的——我也經常與團隊討論——醫療補助計劃在藥物獲取方面仍然有些緩慢。但就我而言，第三季取得了巨大的進展。

Geoff, it is John. The second part of your question is -- was something about investing in this area versus other areas. So I would say from a pipeline perspective with Sof/Vel/Vox being our fourth generation of HCV products now being approved, there really isn't much left in terms of unmatched medical need. And so from a pipeline perspective, this is really the end of what we will be developing in terms of HCV molecules. And that will allow us then to turn our attention to the important aspects in our fibrosis and NASH franchises and our oncology franchises. So we have really largely turned our attention away from HCV to those areas already.

傑夫，我是約翰。你問題的第二部分是關於投資這個領域與其他領域的差異。從產品線的角度來看，隨著Sof/Vel/Vox這四款我們第四代HCV產品核准上市，目前HCV領域幾乎沒有未開發的市場需求。因此，從產品線的角度來看，這實際上標誌著我們在HCV藥物研發方面的工作已經告一段落。這將使我們能夠將注意力轉移到纖維化、NASH和腫瘤領域的重要方面。所以，我們實際上已經將大部分精力從HCV轉移到了這些領域。

Okay. That is helpful. Thanks.

好的，這很有幫助，謝謝。

Thank you. And our next question comes from Brian Abrahams with Jefferies. Your line is now open.

謝謝。下一個問題來自傑富瑞集團的布萊恩亞伯拉罕。您的提問通道已開啟。

Hi, guys. Thanks for taking my question. Norbert, a question on 4997. Wondering if you could talk a little bit more about the go-forward plan there, particularly with respect to potential Phase 3 trial duration and whether or not a fibrosis endpoint might be acceptable just given the effects that you saw in such a such a short time period in Phase 2 and the plan to target more severe progressive patients. And then can you confirm that there were no baseline imbalances in the Phase 2 that might have influenced the fibrosis data or progression to cirrhosis data? Thanks.

大家好。感謝你們回答我的問題。 Norbert，關於4997號試驗，我想請教一下後續計劃，特別是關於三期臨床試驗的潛在持續時間，以及考慮到二期臨床試驗在如此短的時間內觀察到的療效，以及計劃針對病情更嚴重的進展型患者，纖維化終點是否可以接受。另外，能否確認二期臨床試驗中是否存在可能影響纖維化數據或進展為肝硬化數據的基線不平衡？謝謝。

Hi, Brian. So the second question, yes, I can confirm that there were no baseline imbalances. And regarding the Phase 3 study, we are going to make the proposal to regulatory authorities to use just fibrosis as the endpoint. We feel very convinced that, that's the right thing to do because as you may know, fibrosis is the only histological correlate to clinical outcomes. There was a large study published a few years ago where they looked at baseline histology and the correlated histological variables with clinical outcomes and steatosis did not correlate, inflammation didn't correlate, ballooning didn't correlate. The only thing that correlated was fibrosis. So we're going to purpose two Phase 3 studies, both looking at fibrosis 48 weeks as the endpoint.

嗨，Brian。關於第二個問題，是的，我可以確認沒有基線不平衡。關於第三期臨床試驗，我們將向監管機構提議僅以纖維化作為終點。我們堅信這是正確的做法，因為正如您可能知道的，纖維化是唯一與臨床結果相關的組織學指標。幾年前發表的一項大型研究分析了基線組織學以及相關的組織學變數與臨床結果的關係，結果顯示脂肪變性、發炎和氣球樣變異均與臨床結果無關。唯一相關的指標是纖維化。因此，我們將提出兩項三期臨床試驗，均以48週時的纖維化作為終點。

The other thing we're going to do to the studies and if three or four patients begin the rationale, that is where the unmet need is -- then also since ultimately for full approval you will need some clinical endpoint. We think we can get there much faster. Maybe with a 96 week study even if we start off with [F]4 patients. But having all of that said, this all has to be a agreed upon by regulatory authorities. We have a date with the FDA but we have not discussed this with them yet. So stay tuned. Sometime early next year, I think we can update you on the exact plan.

我們打算對研究進行另一項調整，如果三到四名患者開始接受治療，就表示存在未被滿足的醫療需求——因為最終獲得全面批准需要一些臨床終點指標。我們認為我們可以更快地達到目標。即使從[F]4期患者開始，或許也可以透過一項為期96週的研究來實現。但話說回來，這一切都必須得到監管機構的批准。我們已經和FDA約好了時間，但尚未與他們討論此事。敬請關注。我想明年年初的時候，我們可以向大家公佈具體的計畫。

Thanks.

謝謝。

Thank you. And our next question comes from Matthew Harrison of Morgan Stanley. Your line is now open.

謝謝。下一個問題來自摩根士丹利的馬修·哈里森。您的提問通道已開啟。

Thanks. Thanks for taking the call. Sorry, I was on mute. Can I just ask -- you made two comments related to the HPV that I just wanted to get more clarity on. You talked about you're pleased with the 2017 payer cycle. Can you just tell us if we should expect any significant changes in pricing or not? And then can you describe what you think is the size of the Epclusa warehouse? And if you think you've moved through that or you would expect to see some more of that through the end of the year? Thanks.

謝謝。謝謝您接聽電話。抱歉，我剛才靜音了。請問一下，您之前提到過兩點與HPV相關的問題，我想進一步了解。您說您對2017年的支付週期感到滿意。請問價格方面是否會有重大變動？另外，您能否描述一下您認為Epclusa的庫存規模？您認為庫存已經消化完畢，還是預計到年底還會有剩餘？謝謝。

Hi, Mark. It is Kevin Young. I will take your second part first. Yes, there was a small warehousing effect. We think that -- and this is anecdotal and qualitative -- we think that provide is probably how people for a quarter -- two to three month period -- so this is nothing like the warehousing we saw with Sovaldi or with Harvoni. So we think it is largely a Q3 affect. It might go into the fourth quarter, into the quarter now. But we really think it is mostly a 2016 effect.

你好，馬克。我是凱文·楊。我先回答你的第二個問題。是的，確實存在輕微的囤貨效應。我們認為——這只是基於一些零散的定性觀察——供應情況可能持續了一個季度，也就是兩到三個月——所以這和我們之前看到的索非布韋或哈維尼的囤貨情況完全不同。因此，我們認為這主要是第三季的影響。這種情況可能會延續到第四季度，甚至延續到本季。但我們確實認為這主要是2016年的影響。

In terms of our negotiations and contracts, I really can't make any specific comments. Obviously, they are confidential. But we are pleased with the outcome. We feel we are in a strong position for 2017. And most providers will have very, very good access in the private and Medicaid -- Medicare part D setting to both Harvoni and Epclusa. So we think we are in good shape and our providers will have the Gilead options to look forward to giving to their patients as we have done in 2016. So feel good about that.

關於我們的談判和合同，我真的無法發表任何具體評論。顯然，這些都是保密資訊。但我們對結果感到滿意。我們認為我們在2017年處於有利地位。大多數醫療機構，無論是在私人醫療機構或醫療補助計劃（Medicaid）和聯邦醫療保險D部分（Medicare Part D）體系下，都能非常方便地獲得Harvoni和Epclusa這兩種產品。因此，我們認為我們情況良好，我們的醫療機構將能夠像2016年一樣，繼續為他們的患者提供吉利德公司的多種選擇。對此我們感到非常樂觀。

Great. Thanks very much.

太好了，非常感謝。

Thank you. And our next question comes from John Scotti of Evercore ISI.

謝謝。下一個問題來自 Evercore ISI 的 John Scotti。

Hi. Thanks for taking my question. I wanted to ask one on capital allocation if I may. So last year quarter you spoke about potentially having a more complete story of internal and also external programs by year-end. And you've continued to be relatively light on the buyback in 3Q. So a couple of things -- can you characterize right now your current appetite for M&A and if that has changed? Is the current thinking more along the lines of larger transformative deals or should we expect a string of in-licensing deals than what we saw with Filgotinib? And how should we think about the sense of urgency here given your comments and going into year-end? Thanks a lot.

您好。感謝您回答我的問題。我想問一個關於資本配置的問題。去年季度您提到，到年底可能會更全面地介紹內部和外部專案。而且，您在第三季仍然保持相對較低的股票回購規模。所以我有幾個問題——您能否描述一下您目前對併購的興趣，以及這種興趣是否有所改變？目前的想法是更傾向於大型的變革性交易，還是我們預期會有一系列的許可引進交易，而不是像之前收購Filgotinib那樣？考慮到您先前的評論以及即將進入年底，我們應該如何看待目前的緊迫性？非常感謝。

Hi, John. It's John. I think you asked a capital allocations question and then switched your strategy. We will try to answer that for you. As we said in our opening comments, we are still very actively evaluating opportunities. We're actively evaluating a series of different partnerships. But as I said in my comments, we are going to remain disciplined. We're going to keep the bar high. You don't want the sense of urgency to overwhelm your discipline because then you will do things that don't make long-term sense. And that's been the history in all businesses and that's one we apply here. So we are currently very, very active. We will do things when they make sense for us and not before that. And that is really as much as I can say.

嗨，約翰。我是約翰。我想你之前問了一個關於資本配置的問題，然後又改變了策略。我們會盡力回答你的問題。正如我們在開場白中所說，我們仍在積極評估各種機會，包括一系列不同的合作項目。但正如我之前所說，我們會保持嚴謹，堅持高標準。你不能讓緊迫感壓倒你的自律，否則你會做出一些不符合長遠利益的事情。這在所有企業中都是如此，我們在這裡也同樣適用。所以，我們目前非常積極。我們會根據實際情況採取行動，不會操之過急。這就是我能說的全部了。

Thank you and our next question comes from Geoffrey Porges of Leerink partners. Your line is now open.

謝謝，下一個問題來自 Leerink Partners 的 Geoffrey Porges。您的提問通道已開啟。

Thank you very much. I appreciate the question. Robin, just a couple for you if we may. First, operating margins trending down by 200 to 300 basis points a quarter, is that something that we should anticipate continuing or are there some variables in there? Secondly on Epclusa, was there any channel inventory build in the reported number? Lastly, how are you judging this sort of share buyback? You spent $10 billion, as you pointed out, this year and the average cost is sort of around $90 [billion]. Compared to other things that you might've invested in, how are you feeling about that buyback going forward? Thanks.

非常感謝。我很欣賞您的提問。羅賓，如果可以的話，我想問您幾個問題。首先，營業利益率每季下降200到300個基點，這種情況會持續下去嗎？還是說其中存在一些變數？其次，關於Epclusa，報告的數據是否包含了渠道庫存增加？最後，您如何看待這種股票回購？正如您所指出的，您今年花費了100億美元，平均成本約為900億美元。與其他投資項目相比，您對未來的股票回購有何看法？謝謝。

Sure, Geoff. I fill in, in reverse order and adjust the buyback first. We really look at buybacks on a long-term perspective, which is pretty much what I committed or mentioned during the last quarter call. So we are still very comfortable where we are. We did front-load a significant component of our share buybacks. As a matter of fact, I think just in the first quarter we did more than the entire three quarters of 2015. And we mentioned very early on that we would see those declines towards the second half of this year -- very much in alignment with John's comments around being prepared for M&A.

當然，傑夫。我按相反的順序補充說明，先調整回購計畫。我們確實從長遠角度看待股票回購，這基本上也是我在上個季度電話會議上承諾或提到的。所以我們對目前的狀況仍然非常滿意。我們確實提前進行了相當一部分股票回購。事實上，我認為光是第一季我們的回購規模就超過了2015年全年三個季度的總和。我們很早就提到，我們將在今年下半年逐步減少回購規模——這與約翰關於為併購做好準備的說法非常吻合。

It is still clearly part of our capital allocation strategy along with dividends. But I think balancing that with overall looking for growth is something that we are still focused on doing. And as John mentioned, these things take timing to play themselves out. I'll Kevin answer the inventory question but I think to your question of operating margins, yes the quarterization of our margins do get impacted by revenue dynamics as well as expenses. Keep in mind R&D had a $200 million milestone payment -- this quarter included that. But overall, I think our margins still remain high. High relative to overall industry. (Inaudible) we're comfortable with them, we are very prudent with expense management. You saw SG&A expenses down.

這仍然是我們資本配置策略的一部分，與分紅一樣重要。但我認為，如何在追求整體成長的同時平衡分紅是我們目前關注的重點。正如約翰所提到的，這些都需要時間才能見效。凱文，我會回答庫存問題，但關於你提到的營業利潤率，是的，我們利潤率的季度化確實會受到收入動態和支出的影響。請記住，研發部門收到了一筆2億美元的里程碑付款——本季已包含這筆款項。但總體而言，我認為我們的利潤率仍然很高，相對於整個產業而言。 （聽不清楚）我們對目前的利潤率感到滿意，我們在費用管理方面非常謹慎。你也看到了銷售、管理及行政費用下降。

I think the other thing you are slightly seeing is just mix changes between HCV and HIV. That has a little bit of an impact on our gross margins. But overall, with the continued conversion of TAF, long-term you will continue to see that go down. But it will be impacted relative to HPV becoming a smaller component of our total revenue. I cannot really give guidance on our gross margins but I think the bar still remains high for them and we still remain a very disciplined spending type of organization.

我認為您看到的另一種變化是丙型肝炎和愛滋病毒感染病例比例的變化。這會對我們的毛利率產生一定影響。但總體而言，隨著TAF的持續轉化，從長遠來看，您會看到這一比例繼續下降。但相對於HPV在我們總收入中所佔比例的下降，毛利率也會受到影響。我無法給出特定的毛利率預測，但我認為我們的毛利率目標仍然很高，而且我們仍然是一家支出控制非常嚴格的公司。

Geoff, just a comment on Epclusa. If you recall, we launched Epclusa in the last week in quarter two. So that is when our opening inventory went in. Like any growing products, major wholesalers tick up their inventory basically because they've got a standard calculation for days on hand. Basically that just ticks up as the product grows on you. It comes down as the product comes down. Likely, Sovaldi, because it is now becoming Epclusa, will in the future. So there was nothing unnatural about inventory for Epclusa in the third quarter. But as I said, we did get a very nice bump in usage from a small warehousing of patients.

傑夫，關於Epclusa，我只想補充一點。如果你還記得，我們​​在第二季最後一週推出了Epclusa。所以，我們的期初庫存也是在那時入庫的。就像任何正在成長的產品一樣，大型批發商會增加庫存，這主要是因為他們有一套標準的庫存週轉天數計算方法。基本上，隨著產品銷售量的成長，庫存也會隨之增加；隨著銷售量的下降，庫存也會隨之減少。 Sovaldi現在更名為Epclusa，未來很可能也會如此。所以，Epclusa在第三季的庫存狀況並沒有什麼異常。但正如我所說，由於少量患者的使用，我們的銷售確實出現了非常可觀的成長。

Okay. Great. Thanks very much, guys.

好的，太好了，非常感謝各位。

Thank you. And our next question comes from Cory Kasimov from JPMorgan.

謝謝。下一個問題來自摩根大通的科里·卡西莫夫。

Thanks for taking my question. John, I wanted to go back to your comments on the strategic question you just got. When you talk about having a high bar in the M&A front, does that mean you see a lack of interesting opportunities out there that just don't meet that bar or is this more of a price disconnect given the continued volatility in the market? Thanks.

感謝您回答我的問題。約翰，我想回到您剛才對戰略問題的回應。您提到併購方面門檻很高，這是否意味著您認為市場上缺乏符合您高標準的優質投資機會，還是說考慮到市場持續波動，這更多是由於價格脫節造成的？謝謝。

Discipline has both components to it. There are a number of things that I think are probably too early for us to take part in. There are a number of things that I think are just overpriced. And so it has been a combination of those two things going forward -- looking backward. Going forward, we will have to see what makes sense for us and where we are willing to go to bring in new products.

自律包含這兩個面向。有些事情我認為我們現在參與還為時過早。有些事情我認為定價過高。因此，展望未來，我們需要結合這兩方面因素──回顧過去。展望未來，我們必須思考哪些事情對我們有意義，以及我們願意在哪些方面推出新產品。

Okay. Thank you.

好的，謝謝。

Thank you. And our next question comes from Michael Yee of RBC Capital Markets. Your line is now open.

謝謝。下一個問題來自加拿大皇家銀行資本市場的Michael Yee。您的提問通道已開放。

Thanks. Good afternoon. I wanted to ask a question on patient volumes and hep C, specifically as it relates to slide 41. Previously I would've thought that changes in payer access would've opened up the availability to use drugs to get reimbursed for the healthier [F0s and F1s]. I guess with patient volumes flattish, are you seeing these F0s and F1s coming in? Are they coming in? Are they getting treated? Or is there a bottleneck there? They come in and they don't get treated. I just want to understand or dynamic on that and whether you think that, that's going to drive some positives developments on volumes.

謝謝。午安.我想問一個關於丙肝患者數量的問題，特別是與第41張幻燈片相關的部分。先前我認為，隨著支付方政策的改變，對於病情較輕的患者（F0期和F1期），藥物報銷的可能性會大大增加。但現在病患數量似乎趨於平穩，您是否看到這些F0期和F1期病患入院？他們是否入院？他們是否得到了治療？或是否有治療瓶頸？他們入院後卻得不到治療。我只是想了解這方面的動態，以及您是否認為這種情況會推動患者數量的正面成長。

And then in Europe, the same question. Europe declined from 27 down to 21. Do you think -- how do you think that plays out going forward? What are the dynamics there for volumes? Thanks so much.

歐洲的情況也一樣。歐洲的排名從27位下降到21位。您認為－您覺得這種情況未來會如何發展？銷量方面會有什麼樣的變化？非常感謝。

Hi, Michael. Two great questions. Let me try and deal with those in the order. First the US. If you look at our slide, actually the percentage of F0s to F2s has increased over time. It was 50% a little while ago and now it is up to 60%. So clearly a fitter patients, they're less sick are being treated. And of course that's a result of coverage. But I want to say that the patient journey is becoming longer in the US now. If you think about it, patients are really starting further back because they are healthier. We are continuing to see approximately 30,000 patients coming in to specialist care. In other words, 90,000 patients a quarter. 60,000 of those are coming out of the other side and are being treated and cured. That is probably not a bad ratio in itself.

嗨，邁克爾。兩個問題都很好。讓我按順序回答。首先是美國的情況。如果你看一下我們的投影片，實際上，F0 到 F2 階段的比例一直在上升。不久前是 50%，現在已經上升到 60%。顯然，身體狀況較好、病情較輕的患者正在接受治療。當然，這是健保覆蓋範圍擴大的結果。但我想說的是，現在美國患者的就診過程越來越長了。仔細想想，由於患者身體狀況較好，他們實際上開始就診的時間更早。我們仍然看到大約 3 萬名患者前來接受專科治療。換句話說，每季有 9 萬名患者。其中 6 萬名患者最終康復出院。這個比例本身可能還不錯。

Not every patient is treated and not every patient is immediately treated. Now we shouldn't forget that sometimes patients drift in and out of specialist care. Some patients have compounding factors that complicate the start of therapy -- most notably drug use or alcohol use.

並非所有患者都能得到治療，也並非所有患者都能立即得到治療。我們不應忘記，有時患者會斷斷續續地接受專科治療。有些患者存在一些複雜因素，會使治療的開始變得困難——最常見的是藥物濫用或酗酒。

But the patients who are just less sick, have less motivation themselves, and the physician has less motivation to really push those through therapy. And lastly, the paperwork and the administrative process for authorization is still there like it is with any specialist product. So I think those are mostly the dynamics. And it's mostly around the patient being less time in the physician's practice. They're not patients that have been held for a long time. They're not patients that's failed one or two prior therapies and a great urgency by the physician.

但病情較輕的患者自身動力不足，醫師也缺乏動力督促他們完成治療。最後，和其他專科藥物一樣，審批所需的文書工作和行政流程依然存在。所以我認為這些都是主要原因。這主要是因為患者在醫師診所就診的時間較短。他們並非長期滯留的患者，也不是那些嘗試過一兩種療法都無效，醫生也並非迫切希望他們接受治療的患者。

In terms of Europe, as I said we did see a downtick in the patients treated in the southern European markets, primarily Italy and Spain. And I think that is because they are working through the sicker patients and are becoming more like France and Germany. There still are more patients in southern European markets but I do think they are clearing the most obvious patients to treat and cure. And I want to emphasize that market share has stayed very, very solid in those markets. And while there is not an obvious mechanism through advertising, television advertising in the European markets, we are doing a lot of partnership with KOLs, with societies, with patient groups to, again, or try to encourage the right screening practices and the right transfer of patients into specialist care.

就歐洲而言，正如我之前所說，我們確實看到南歐市場（主要是義大利和西班牙）的患者數量有所下降。我認為這是因為他們正在優先處理病情較重的患者，並逐漸向法國和德國的模式靠攏。南歐市場的患者數量仍然較多，但我認為他們正在優先治療和治癒那些病情最明顯的患者。我想強調的是，我們在這些市場的市佔率仍然非常穩固。雖然在歐洲市場，透過廣告（尤其是電視廣告）並沒有明顯的有效途徑，但我們正在與意見領袖、協會和患者團體進行大量合作，以期再次強調或鼓勵正確的篩檢方法，並確保患者能夠及時轉診至專科醫生處。

Thanks.

謝謝。

Thank you and our next question comes from Robyn Karnauskas of Citibank.

謝謝，我們的下一個問題來自花旗銀行的 Robyn Karnauskas。

Hi. Thank you for the question. Just to ask the [HCV] question from a fourth quarter impaired perspective. And the last fourth quarter you started to see hints of changes in HCV. So given it looks like US has stabilized, are you seeing anything that hints that payers could change, how they are viewing the earning changes in the fourth quarter that you are seeing that could influence 2017? And then given -- you've maintained guidance, how are you thinking now about providing -- what kinds of guidance you might provide in 2017 to help investors feel comfortable that you can predict going forward? Any -- I know you can't give guidance. But can you give any hints on how you are thinking about giving us some color on next year? Thanks.

您好。感謝您的提問。我想從第四季受損的角度詢問一下關於C型肝炎（HCV）的問題。去年第四季度，丙型肝炎似乎開始出現一些變化跡象。鑑於美國市場目前看起來已經趨於穩定，您是否觀察到任何跡象表明支付方可能會改變對第四季度盈利變化的看法，而這些變化可能會影響2017年的業績？另外，鑑於您一直維持業績指引，您現在打算如何提供—您會在2017年提供哪些類型的業績指引，以幫助投資者相信您能夠預測未來的業績？我知道您不能給出業績指引，但您能否透露一些關於明年業績的計劃？謝謝。

Hi, Robin. I will take the first part. I think, again, come back to the quality of the discussions that we had for 2017 contracting and I think they were very good. Let's not forget the fact that Gilead are in a very strong place by virtue of our Harvoni being in a good proportion of patients in eight week therapy. So that is a very big advantage for us. And I think that is really appreciated from the point of view of managing costs from a commercial payer.

你好，羅賓。我先回答第一部分。我想，我們還是應該回到2017年合約談判的品質上來，我認為談判非常成功。別忘了，吉利德之所以處於非常有利的地位，是因為我們的Harvoni在八週療程中已惠及相當一部分患者。這對我們來說是一個巨大的優勢。我認為，從商業支付方控製成本的角度來看，這一點也確實非常重要。

We didn't see much change in the ratio of the public to private payer in the third quarter. It was still about 45% of patients who were covered as a public patient as opposed to a commercial or Medicare part D plan. Part of the commercial, part of the markets, is of course the VA. The VA was a little bit lower in the third quarter versus the second quarter. They still seem to be very enthusiastic, very engaged in recalling patients. But I think that is perhaps one of the variables that will kind of unfold in 2017 is the VA and their continuing ability to recall and treat patients. But I think with our efforts around highlighting the CDC need to treat the baby boomers and the activity of all companies involved in hepatitis C, I would like to think we can continue our progress in 2017.

第三季度，公費與私費的比例變化不大。約45%的患者仍由公費支付，而非商業保險或聯邦醫療保險D部分計畫。商業保險市場的一部分，當然也包括退伍軍人事務部（VA）。第三季VA的就診率略低於第二季。他們似乎仍然非常積極，並積極主動地召回患者。但我認為，VA能否持續召回和治療患者，或許是2017年需要關注的變數之一。但我相信，憑藉我們強調疾病管制與預防中心（CDC）需要治療嬰兒潮世代以及所有參與C型肝炎防治的公司的積極行動，我們能夠在2017年繼續取得進展。

Robyn, it is Robin. I will take the second part of that question. Yes, as you know, I think as we said, this is the curative market, [HCV], and it is difficult to predict. Kevin just outlined this kind of patient journey taking a longer bit of time and just changing dynamics. And we've spend a lot of time this fall working through the planning cycle, figuring out what that means around 2017 and beyond. Obviously, I cannot give the answer yet but how we guide will again depend on our ability to bracket the risk and opportunities around those dynamics and what those mean. It continues to change and it's something that we monitor very closely. But that patient flow, as Kevin said, is something that is just very difficult for us to control.

我是羅賓，Robyn。我來回答問題的第二部分。是的，如你所知，正如我們之前所說，這是C型肝炎的治療市場，很難預測。凱文剛才概述了這類患者的治療過程需要更長時間，而且情況也在不斷變化。今年秋季，我們花了很多時間進行規劃，思考這些變化對2017年及以後意味著什麼。顯然，我現在還無法給出答案，但我們如何進行指導將取決於我們能否準確掌握這些變化帶來的風險和機遇，以及它們意味著什麼。情況一直在變化，我們會密切注意。但正如凱文所說，患者流量是我們很難控制的。

Yes and, Robin, if I might -- how solid and good we feel about HIV going into next year with that chronic model and the uptick of our top-based regimens.

是的，羅賓，如果可以的話——我們對明年愛滋病防治工作的信心非常堅定，因為我們採用了慢性病治療模式，並且以治療上調為基礎的治療方案也得到了推廣。

Thank you.

謝謝。

Thank you and our next question comes from Ying Huang of Bank of America Merrill Lynch. Your line is now open.

謝謝，下一個問題來自美國銀行美林證券的黃穎。您的提問通道已開啟。

Thanks for taking my question. The first one maybe is for Kevin. Our channel check indicated that VA is paying about $15,000 to $17,000 per patient. Do you think that is the absolute floor for HCV pricing? And then another question for John and Robin, it sounds like you guys have a really highball for acquisitions. If you don't deploy capital in that position, would you consider hiking dividends to a much higher level like 5% or 6% so that a lot of investors would be willing to take some off of dividend payment? Thank you.

感謝您回答我的問題。第一個問題可能想問凱文。我們的渠道調查顯示，退伍軍人事務部（VA）為每位患者支付的費用約為 15,000 至 17,000 美元。您認為這是丙型肝炎治療（HCV）定價的最低標準嗎？另外還有一個問題想問約翰和羅賓，聽起來你們對收購的期望很高。如果你們不打算在這方面投入資金，是否會考慮將股息提高到更高的水平，例如 5% 或 6%，以便吸引更多投資者願意接受股息？謝謝。

Hi, Ying. It is Kevin. I apologize but in terms of commenting on our net pricing to the various channels to the various constituents, it is not something that we directly comment on. So I couldn't go any further than that at this time.

你好，Ying。我是Kevin。很抱歉，關於我們面向各個管道和不同客戶的淨定價，我們不直接發表評論。所以目前我無法透露更多。

Yes, Ying, I will take the second half. As we said, the bar is high but we are very engaged and remain engaged in M&A. And when we think about our overall capital allocation, we would not want to do anything that would constrain us with -- and reduce our flexibility to purchase if we found something that we thought could really grow our path line. So we talked with our board all of the time about dividend increases and dividends in general as well as share repurchases and that is something that we will continue to do.

是的，穎，我來回答後半部。正如我們所說，標準很高，但我們一直積極參與併購活動。在考慮整體資本配置時，我們不希望做任何會限制我們收購靈活性的事情——如果我們發現真正能夠拓展業務線的項目，我們絕對不會輕易出手。因此，我們一直與董事會討論提高股利、股利分配以及股票回購等問題，我們也會繼續這樣做。

Thank you.

謝謝。

Thank you and our next question comes from Phil Nadeau of Cowen and Company. Your line is now open.

謝謝，下一個問題來自考恩公司的菲爾納德奧。您的提問通道已開啟。

Good evening. Thanks for taking my question. Unfortunately, it is another one on HCV pricing for you, Kevin. You mentioned two factors that impact the average per patient price that have been changing. One is the public versus private payer mix, which you said changed over the last year but maybe stabilized now and then also the rebates given to private payers. You didn't really discuss those too much on this call but in the past your predecessor said that he expected the rebates to actually increase when Merck entered the market next year.

晚安.感謝您回答我的問題。很遺憾，凱文，我的問題又是關於C型肝炎定價的。您提到有兩個因素會影響每位患者的平均價格，這兩個因素一直在改變。一是公共和私人支付方的比例，您說過去一年裡這個比例有所變化，但現在可能已經穩定下來了；二是私人支付方獲得的返利。您在這次電話會議上並沒有過多討論這些，但您的前任曾說過，他預計默克公司明年進入市場後，返利實際上會增加。

Some of your comments today could suggest the opposite. So I guess I'm kind of just curious for 2017, how should we think about those two factors? Do you think public versus private has plateaued? Is 45% the number we should be thinking about for 2017? And then on the rebates to private payers, should we continue to expect those to tick up in 2017? Or is you feeling different now that you've gone through the negotiation cycles? Thanks.

您今天的一些評論似乎表明了相反的觀點。所以我想問的是，對於2017年，我們該如何看待這兩個因素？您認為公立和私立醫療的比例是否已經趨於穩定？ 45%是我們應該在2017年考慮的數字嗎？至於對私立支付方的回扣，我們是否應該繼續預期這些回扣在2017年會持續成長？或者，經歷了談判週期之後，您現在的看法有所不同？謝謝。

Difficult for me to comment in any great detail, Phil, on either of those questions. I will take the commercial first. They have gone well. I think, as I keep emphasizing, the advantage we have in eight weeks -- think about it -- 45% right now of Harvoni patients, genotype 1 patients are receiving eight weeks. So if you think about 45% of genotype 1 with just that eight weeks, that is a very good economic offering for our payers that they really appreciate. So, I believe we have done very well in our position going into 2017.

菲爾，關於這兩個問題，我很難詳細評論。我先說說商業方面。商業方面進展順利。正如我一直強調的，我們在八週療程方面的優勢顯而易見——想想看——目前45%的Harvoni患者，也就是1型基因型患者，都在接受八週療程。所以，想想看，光是八週療程就能讓45%的1型基因型患者受益，這對我們的支付者來說是一個非常划算的經濟方案，他們對此非常讚賞。因此，我相信我們在進入2017年之際，已經取得了非常好的成績。

In terms of the ratio between public and private, again, very difficult for me to make a prediction. VA did come down a little bit. But there was an increase just a tick up to replace that by Medicaid. I made the comment that Medicaid opening is really slower than we would like. But I think there may be that change in mix going forward. Difficult to predict VA -- still a big part of the public. And we will just have to see. It is very impressive what they've had done and I know they are very committed. And they feel that they haven't done their job yet. We, and that is Gilead, we estimate that between 35% and 40% of the patients in the VA system have been treated to date. So still a lot of work to do and now I think they want to do it. So 45%, 55% seems to have been the level for the last couple of quarters. And not entirely clear if that is going to be maintained into 2017 but it seems reasonable to me.

就公立和私立醫療機構的比例而言，我很難做出預測。退伍軍人事務部（VA）的醫療服務量確實略有下降，但醫療補助計劃（Medicaid）略有上升，以彌補這一缺口。我之前說過，醫療補助計畫的開放速度確實比我們預期的要慢。但我認為未來這種比例可能會有所改變。 VA的醫療服務量很難預測——它仍然是公立醫療機構的重要組成部分。我們只能拭目以待。他們所取得的成就令人印象深刻，我知道他們非常投入。他們也覺得自己的工作還沒完成。我們（吉利德公司）估計，迄今為止，VA系統中只有35%到40%的患者接受了治療。所以還有很多工作要做，現在我認為他們也想繼續努力。過去幾個季度，治療率似乎維持在45%到55%之間。目前還不完全清楚這個水準能否維持到2017年，但我覺得這個數字是合理的。

That's helpful. Thanks for taking the question.

這很有幫助。謝謝你回答這個問題。

Thank you and our next question comes from Alethia Young of Credit Suisse. Your line is now open.

謝謝，下一個問題來自瑞士信貸的阿萊西亞·楊。您的提問通道已開通。

Hi, guys. Thanks for taking my question. I want to talk a little bit about Genvoya launch and how it is faster than even the Atripla launch, which was obviously a very good launch. Maybe if you could just frame what's been how doctors are looking at this. Are they looking at it more kind of -- for everyone that needs to come to the doctor, they just go and get this drug? Just give us more flavor on the dynamics. Thanks.

大家好。感謝你們回答我的問題。我想談談Genvoya的上市情況，以及它比Atripla的上市速度更快的原因——Atripla的上市顯然非常成功。能否請你們談談醫生們是如何看待這款藥的？他們是否認為──所有需要就醫的人都可以直接服用這種藥？能否請你們更詳細地介紹一下這方面的市場動態？謝謝。

Alethia, thanks for an HIV question. I really appreciate it. (laughter) Alethia, I was just at our international advisory board a couple of weeks ago and we had some of the foremost HIV doctors from around the world. And it was absolutely unanimous. The commitment to switching patients. All things being equal, particularly in terms of pricing, physicians see the benefit in terms of bone and kidney from the point of view of TAF. So I think there is an awful strong commitment. Let's not forget that in most practices now, half of the patients are over the age of 50 and they have been on long-term therapy. And physicians just see a natural and fairly straightforward switch going on.

阿萊西亞，謝謝你問關於愛滋病的問題，我非常感謝。 （笑）阿萊西亞，幾週前我剛參加了我們的國際顧問委員會會議，會上匯聚了來自世界各地的一些頂尖愛滋病專家。大家的意見完全一致：致力於幫助患者轉換治療方案。在其他條件相同的情況下，尤其是在價格方面，醫生們從TAF（治療相關因子）的角度看到了骨骼和腎臟方面的益處。所以我認為大家對此都非常支持。別忘了，現在大多數診所裡，有一半的患者都超過50歲，而且他們已經接受了長期治療。醫生們看到的是一個自然而然、相當直接的轉換過程。

And I really didn't think I would ever see an uptake quicker than Atripla. As you remember, they were the components of Atripla that could just be put together and the patients switch. These are slightly different with Genvoya because it is the switch of regimen. So I'm delighted with the way it is going. 80% of Genvoya comes from switches and right now half of those switches are from [Stryvle] which is the natural TAF to -- TDF to TAF switch.

我真的沒想到會有比 Atripla 更迅速的推廣。您可能還記得，Atripla 的各個組成部分可以組合起來，患者可以直接轉換使用。 Genvoya 的情況略有不同，因為它涉及的是治療方案的轉換。所以我對目前的進展非常滿意。 Genvoya 80% 的銷量都來自治療方案的轉換，而目前這些轉換中有一半來自 [Stryvle]，這是從 TAF 到 TDF 再到 TAF 的自然轉換。

So my expectation is that we will continue to convert patients. I am super enthusiastic about it. And once we get more countries online in Europe, I think we can have that same expectation. Germany is going great. Spain is going great and we are on the threshold of getting the most important market up and running and that is France.

所以我預計我們會繼續提高患者轉換率。我對此充滿信心。一旦我們在歐洲更多國家上線，我認為我們也能保持同樣的預期。德國和西班牙的進展都非常順利，我們即將迎來最重要的市場—法國。

Thank you and our next question comes from Terence Flynn of Goldman Sachs. Your line is now open.

謝謝，下一個問題來自高盛的特倫斯·弗林。您的提問通道已開啟。

Hi. Thanks for taking the question. Maybe just wondering if you guys can comment about the GSKV doublets for HIV. Maybe just help frame for us how think about that, if those aren't successful and either treatment or maintenance setting. Would you look to explore your own doublet regimen or do you think you have already set a high enough bar there? Thank you.

您好。感謝您回答這個問題。我想請教各位，關於GSKV雙藥療法治療HIV感染，能否分享一下經驗？如果這些療法無效，無論是在治療或維持治療階段，您能否幫助我們理清思緒？您會考慮研發自己的雙藥療法方案嗎？還是您認為目前已經取得了足夠的成功？謝謝。

Terrace, the debate in our -- with bictegravir is not doublet or triplet. We are developing bictegravir [epitaph] because it has three excellent components that have proven safety and enormously high efficacy. If you look at the [V triomec] compound, of course that contains [abavacavir]. In that scenario, there is an incentive to get rid of abavacavir and go to a doublet, as you call it. But in our case, that is absolutely -- we have no incentive whatsoever to do that. I would like to point it is an interesting strategy. It is a potential competitor. The only thing I would like to point out, the safety and efficacy has to be still proven in a larger patient population, number one. And number two, in a more diverse patient population -- particularly in patients with high viral levels.

Terrace，我們關於比克替拉韋的爭論並非在於雙聯療法還是三聯療法。我們開發比克替拉韋（Epitaph）是因為它包含三種卓越的成分，這些成分已被證實具有安全性和極高的療效。如果您看看V Triomec化合物，它當然含有阿巴伐卡韋。在這種情況下，人們有動機去除阿巴伐卡韋，轉而採用您所說的雙聯療法。但就我們而言，我們絕對沒有這樣做的動機。我想指出的是，這是一個有趣的策略，也是一個潛在的競爭對手。我唯一想強調的是，首先，其安全性和有效性仍需在更大規模的患者群體中得到驗證。其次，需要在更多樣化的患者群體中驗證——尤其是在病毒量高的患者群體中。

Thank you and our next question comes from Ian Somaiya of BMO Capital Markets.

謝謝，我們的下一個問題來自 BMO 資本市場的 Ian Somaiya。

Thanks for taking my question. A question for Robyn on R&D spend going forward. The Filgotinib program Phase 3 programs may in aggregate cost about $1 billion. You are about to embark on a fairly sizable NASH program. Just how should we think about R&D spend going forward? Are there any trials that are completing that might provide an offset? If you could give us some color related to that.

感謝您回答我的問題。我有個關於未來研發支出的問題想問Robyn。 Filgotinib計畫的三期臨床試驗總成本可能約為10億美元。您即將啟動一個規模相當大的NASH專案。我們該如何看待未來的研發支出？目前是否有任何即將完成的試驗可以抵銷部分研發支出？如果您能提供一些相關信息，那就太好了。

Yes, so maybe, Ian, I'm going to answer the first question and Robin can join in. So you know, as we indicated before, our hepatitis C research is winding down. Or the development is winding down. Really with this [soft well] box, this would be our last development candidate. And we have spent over the last three years probably most of our money on hepatitis C. So that is winding down. And also HIV is coming down because Bictegravir/F/TAF is going to be our last single tablet regimen for a broad patient population. And that I think will offset the increased spending in the other areas as you pointed out Filgotinib in oncology.

是的，伊恩，或許我可以先回答第一個問題，然後羅賓可以加入討論。正如我們之前提到的，我們的C型肝炎研究正在逐步結束，或者說開發工作正在逐步結束。實際上，有了這個（軟孔）試劑盒，這將是我們最後一個在研候選藥物。過去三年，我們可能把大部分資金都投入了C型肝炎的研發中，所以這部分工作正在逐步結束。同時，愛滋病毒的研發也逐漸減少，因為比克替拉韋/F/TAF 將成為我們針對廣大病患族群的最後一個單片複方製劑。我認為這將抵消我們在其他領域（例如腫瘤學領域的菲爾戈替尼）增加的支出。

I think Norbert summed it up, Ian. I'd only add that I thing the rigor remains very high internally within Gilead as well. We're always making a very straight off and we look to do it right thing scientifically. So you could see variability in cost. But overall, there is still a high bar internal of how we allocate our research spend. But a lot of our projects ongoing, as mentioned, will be paid for with the decline in some of the larger products we've had with HIV and HCV.

伊恩，我覺得諾伯特總結得很好。我只想補充一點，我認為吉利德內部的嚴謹性依然非常高。我們始終秉持著非常直接的態度，力求在科學上盡善盡美。因此，成本可能會有所波動。但總的來說，我們在研發經費分配方面仍有很高的標準。正如前面提到的，我們許多正在進行的項目，其資金將來自我們一些大型愛滋病和丙型肝炎產品的銷售下滑。

Our final question comes from the line of Jim Birchenough with Wells Fargo. Your line is now open.

最後一個問題來自富國銀行的吉姆‧伯奇諾夫。您的提問通道已開放。

Jim, are you there?

吉姆，你在嗎？

Again, Jim, your line is now open. Please check your mute button.

吉姆，你的線路已通。請檢查你的靜音按鈕。

I think that is it, Candace.

我想就是這樣了，坎迪斯。

There are no further questions at this time. I would like to turn the conference back over to Sung Lee for closing remarks.

目前沒有其他問題了。現在我將會議交還給李成先生，請他作總結發言。

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

謝謝坎迪斯。感謝各位今天蒞臨。我們非常感謝大家一直以來對吉利德的關注，我們的團隊期待在未來繼續為大家帶來最新的進展。

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。會議到此結束，大家可以斷開連線了。祝大家今天過得愉快。