吉利德科學 (GILD) 2017 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Fourth Quarter 2017 Earnings Conference Call. My name is Candace, and I will be your conference operator today. (Operator Instructions) And as a reminder, this conference call is being recorded.

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2017年第四季財報電話會議。我叫坎迪斯，今天我將擔任你們的會議接線生。（操作員說明）再次提醒，本次電話會議正在錄音。

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

現在我將把電話交給投資人關係副總裁李成先生。請繼續。

Thank you, Candace, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the fourth quarter and full year 2017. 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，我們發布了一份新聞稿，公佈了 2017 年第四季和全年的獲利結果。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。

The speakers on today's call will be John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; and Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer. Also in the room with us for the Q&A session is Andrew Cheng, Executive Vice President, Clinical Research and Development Operations.

今天電話會議的發言人有：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；以及研發執行副總裁兼首席科學官諾伯特·比肖夫伯格。與我們一同參加問答環節的還有臨床研究與開發營運執行副總裁 Andrew Cheng。

Before we begin with our prepared comments, 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.

在我們開始發表準備好的評論之前，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，這些因素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。

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.

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。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 Robin.

現在我會把通話轉給羅賓。

Thank you, Sung, and good afternoon, everyone. We are pleased to share our results for the fourth quarter and full year 2017 and provide 2018 guidance. I'll first review the financial results and commercial highlights for the quarter, Norbert will discuss progress made in R&D and John will make a few closing comments.

謝謝宋，大家午安。我們很高興與大家分享 2017 年第四季和全年的業績，並提供 2018 年的業績指引。我將首先回顧本季的財務表現和商業亮點，Norbert 將討論研發方面的進展，John 將作總結發言。

2017 was marked by operational excellence across the business. During the year, we raised net product revenue guidance as we observed strong performances across our HIV and cardiopulmonary franchises. We continue to execute on and maximize the opportunity in HCV in a changing competitive landscape. We made 2 strategic acquisitions, Kite and Cell Design Labs, positioning us as an industry leader in cell therapy. Furthermore, we launched 2 new products: Yescarta, the first cell therapy approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma; and Vosevi, an important option for HCV patients who could not be cured with other therapies.

2017年，公司各部門的營運都表現卓越。年內，由於我們在 HIV 和心肺產品領域表現出色，因此提高了淨產品收入預期。在競爭格局不斷變化的背景下，我們將繼續掌握並最大限度地利用丙型肝炎領域的機會。我們進行了兩項策略性收購，分別是 Kite 和 Cell Design Labs，這使我們成為細胞治療行業的領導者。此外，我們也推出了兩款新產品：Yescarta，第一款獲準用於治療復發或難治性大B細胞淋巴瘤成年患者的細胞療法；以及Vosevi，對於其他療法無法治癒的丙型肝炎患者來說，這是一個重要的選擇。

Turning to the financials. For the fourth quarter 2017, total revenues were $5.9 billion with non-GAAP diluted earnings per share of $1.78. For the full year 2017, total revenues were $26.1 billion with non-GAAP diluted earnings of $8.84 per share.

接下來來看財務數據。2017 年第四季總營收為 59 億美元，非 GAAP 稀釋後每股收益為 1.78 美元。2017 年全年總收入為 261 億美元，非 GAAP 稀釋後每股收益為 8.84 美元。

Product sales for the fourth quarter were $5.8 billion and $25.7 billion for the full year. HIV and HBV product sales for the full year 2017 were $14.2 billion compared to $12.9 billion in 2016. The increase was primarily due to the strong uptake of our TAF-based regimens, which now accounts for 62% of Gilead's total HIV prescription volume in the U.S. At the end of 2017, Genvoya remained the most prescribed HIV therapy for treatment-naïve and switch patients in the U.S. and across the top 5 European markets. Genvoya represents the most successful HIV launch in the U.S. and is the first HIV product to reach $3 billion in annual sales.

第四季產品銷售額為 58 億美元，全年銷售額為 257 億美元。2017 年全年 HIV 和 HBV 產品銷售額為 142 億美元，而 2016 年為 129 億美元。這一成長主要歸功於我們基於 TAF 的治療方案的強勁普及，該方案目前佔吉利德在美國 HIV 處方總量的 62%。截至 2017 年底，Genvoya 仍然是美國和歐洲前五大市場中，初治和轉換治療患者使用最多的 HIV 治療藥物。Genvoya 是美國最成功的 HIV 藥物上市案例，也是第一個年銷售額達 30 億美元的 HIV 產品。

In Europe, sales of our TAF-based regimens continued to grow while generic TDF and TDF/FTC are available in several countries. Truvada for PrEP has remained a growth driver for Gilead. At the end of last year, approximately 153,000 people in the U.S. were taking Truvada for this indication, representing a greater than fivefold increase since January 2015.

在歐洲，我們基於 TAF 的治療方案的銷售額持續成長，而仿製藥 TDF 和 TDF/FTC 已在多個國家上市。Truvada（用於暴露前預防）一直是吉利德的成長動力。截至去年年底，美國約有 153,000 人服用 Truvada 治療該疾病，比 2015 年 1 月增加了五倍多。

HCV product sales were $9.1 billion compared to $14.8 billion in 2016. The arrival of new competition, along with fewer patient starts, contributed to the year-over-year decline. As we have noted in the past, HCV revenues are driven by 4 variables: patient starts, net pricing, market share, and treatment duration. Treatment duration has stabilized as a variable, and pricing of all regimens has gravitated towards the 8-week regimen price. We anticipate both pricing and market share to stabilize by mid-2018 with more predictable but slightly declining patient starts moving forward.

丙型肝炎產品銷售額為 91 億美元，而 2016 年為 148 億美元。新競爭對手的出現，以及新患者數量的減少，導致了同比下降。正如我們過去所指出的，HCV 收入受 4 個變數驅動：患者數量、淨定價、市場份額和治療持續時間。治療持續時間這一變數已趨於穩定，所有治療方案的價格都向 8 週治療方案的價格靠攏。我們預計到 2018 年年中，價格和市場份額都將趨於穩定，患者數量將更加可預測，但會略有下降。

Finally, other product sales were $2.3 billion compared to $2.2 billion in 2016. This represents the outstanding performance of the cardiovascular franchise. Ranexa and Letairis together generated $1.6 billion in revenue in 2017. As a reminder, the patent for ambrisentan in the U.S. will expire in July of 2018.

最後，其他產品銷售額為 23 億美元，而 2016 年為 22 億美元。這體現了心血管業務的優異表現。Ranexa 和 Letairis 在 2017 年共創造了 16 億美元的收入。提醒大家，安立生坦在美國的專利將於 2018 年 7 月到期。

Turning to expenses for the full year 2017. Non-GAAP R&D expenses were $3.3 billion, and SGA expenses were $3.4 billion, both of which were in line with expectations. With the recent enactment of the Tax Cuts and Jobs Act, or tax reform, we reported a provisional estimated GAAP charge of $5.5 billion or $4.16 per share in the fourth quarter of 2017. This will be payable over the next 8 years and has been excluded from our non-GAAP results for the fourth quarter and full year.

接下來來看看2017年全年的支出狀況。非GAAP研發費用為33億美元，銷售、管理及行政費用為34億美元，皆符合預期。隨著《減稅與就業法案》（即稅收改革）的頒布，我們在 2017 年第四季報告了 55 億美元或每股 4.16 美元的初步 GAAP 費用估計。這筆款項將在未來 8 年內支付，並已從我們第四季和全年的非 GAAP 業績中剔除。

Tax reform will have a positive impact on Gilead's earnings by lowering our global effective tax rate and increasing our financial flexibility as a result of our ability to repatriate our ex U.S. cash over time. While the Tax Cuts and Jobs Act does not fundamentally change our capital allocation priorities, it does enable Gilead to invest in sustainable, long-term, value-creating opportunities, which include investing in R&D, expanding U.S.-based manufacturing and creating additional jobs in the U.S.

稅收改革將透過降低我們的全球有效稅率並提高我們的財務靈活性，從而對吉利德的收益產生積極影響，因為我們能夠隨著時間的推移將美國境外的現金匯回國內。雖然《減稅與就業法案》並沒有從根本上改變我們的資本配置優先事項，但它確實使吉利德能夠投資於可持續的、長期的、創造價值的機會，包括投資研發、擴大美國本土的生產以及在美國創造更多的就業機會。

Moving to our balance sheet. Our business continues to deliver strong operating cash flows. We generated $11.9 billion in cash from operations for the full year 2017 and ended the year with $36.7 billion in cash and investments. In conjunction with the Kite acquisition, we issued $3 billion senior unsecured notes and $6 billion term loan facilities, of which we repaid $1.5 billion in the fourth quarter 2017.

接下來來看看我們的資產負債表。我們的業務持續帶來強勁的營運現金流。2017 年全年，我們從經營活動中獲得了 119 億美元的現金，年底現金和投資總額為 367 億美元。為配合對 Kite 的收購，我們發行了 30 億美元的優先無擔保票據和 60 億美元的定期貸款，其中我們在 2017 年第四季償還了 15 億美元。

For the full year, we paid cash dividends of $2.7 billion and repurchased 13 million shares of stock for $954 million. Earlier today, we announced a 10% increase in our quarterly dividend from $0.52 to $0.57 per share, which will become effective in the first quarter of 2018. This increase underscores the confidence of the board and management and the strength of the business and future cash flows.

全年共支付現金股利 27 億美元，並以 9.54 億美元的價格回購了 1,300 萬股股票。今天早些時候，我們宣布將季度股息提高 10%，從每股 0.52 美元增至 0.57 美元，該調整將於 2018 年第一季生效。這一成長凸顯了董事會和管理層的信心，以及公司業務的實力和未來現金流的良好前景。

Our capital allocation priorities going forward include: investment in research and development, along with M&A and partnerships to augment our pipeline; delevering our capital structure; continued growth of our dividend over time; and share repurchases to maintain our current share count.

我們未來的資本配置重點包括：投資研發，以及透過併購和合作來擴充我們的產品線；降低資本結構槓桿率；持續提高股利；以及回購股票以維持我們目前的股份數量。

Finally, I would like to cover our full year 2018 non-GAAP financial guidance, summarized on Slides 33 through 37 in the earnings presentation available on our corporate website. Net product sales are expected to be in the range of $20 billion to $21 billion. Further details on our HCV sales and loss of exclusivity of ambrisentan, tenofovir DF and FTC in Europe can be found on Slides 34 through 36.

最後，我想介紹一下我們 2018 年全年非 GAAP 財務預期，該預期總結在我們公司網站上提供的盈利演示文稿的第 33 至 37 頁。預計淨產品銷售額將在 200 億美元至 210 億美元之間。有關我們在歐洲的 HCV 銷售以及安立生坦、替諾福韋酯和 FTC 失去獨家銷售權的更多詳細信息，請參見幻燈片 34 至 36。

Our guidance is subject to a number of uncertainties, including: the accuracy of our assumptions about HCV market share; the accuracy of our estimates for HCV patient starts in 2018; unanticipated pricing pressures from payers and competitors in the HCV market; lower-than-expected market share and greater price erosion resulting from the sale of generic versus a TDF, the fixed-dose combination of FTC/TDF and the fixed-dose combination of FTC/TDF/efavirenz outside the U.S.; slower-than-anticipated growth in our HIV franchise; a greater-than-expected adoption of generic versions of ambrisentan for PAH in the U.S.; a larger-than-anticipated shift in payer mix to more highly discounted payer segments such as PHS, FFS, Medicaid and the VA; as well as volatility in foreign currency exchange rates.

我們的預測受到許多不確定因素的影響，包括：我們對丙型肝炎市場份額的假設是否準確；我們對2018年丙型肝炎患者起始治療人數的估計是否準確；丙型肝炎市場支付方和競爭對手帶來的意外定價壓力；在美國以外地區，由於仿製藥與TDF、FTC/TDF固定劑量複方製劑以及FTC/TD F/依非韋倫固定劑量複方製劑的銷售相比，市場份額低於預期，價格侵蝕更大；我們的HIV業務增長速度低於預期；美國PAH患者使用安立生坦仿製藥的比例高於預期；支付方結構向折扣更高的支付方（如PHS、FFS、Medicaid和VA）的轉變幅度高於預期；以及外匯匯率更高的支付方（如PHS、FFS、Medicaid和VA）的轉變幅度高於預期的波動。

Non-GAAP product gross margins are expected to be in the range of 85% to 87%. We expect our non-GAAP R&D expenses to be in the range of $3.4 billion to $3.6 billion. We also expect our non-GAAP SG&A expenses to be in the range of $3.4 billion to $3.6 billion. For the full year, our non-GAAP effective tax rate is expected to be in the range of 21% to 23%, which reflects the effect of the recently enacted U.S. tax reform. We anticipate the full year diluted EPS impact of acquisition-related stock-based compensation and other expenses to be in the range of $1.41 to $1.51 per share.

非GAAP產品毛利率預計在85%至87%之間。我們預計非GAAP研發費用將在34億美元至36億美元之間。我們也預期非GAAP銷售、管理及行政費用將在34億美元至36億美元之間。預計全年非GAAP有效稅率將在21%至23%之間，這反映了近期頒布的美國稅改的影響。我們預計，與收購相關的股票選擇權費用和其他費用對全年稀釋後每股盈餘的影響將在每股 1.41 美元至 1.51 美元之間。

As we begin 2018, we remain committed to being an operationally and financially efficient organization that generates high operating margins.

2018 年伊始，我們將繼續致力於成為一個營運和財務高效、能夠產生高營運利潤率的組織。

I will now turn the call over to Norbert.

現在我將把通話轉給諾伯特。

Thank you, Robin. As I look across our numerous research and development programs, I'm excited about the potential we have to advance treatment for a variety of diseases where significant unmet medical need exists. I will spend the next few minutes detailing our progress in HIV, liver disease, inflammation and oncology and discuss some of the key milestones we anticipate in 2018.

謝謝你，羅賓。縱觀我們眾多的研發項目，我感到非常興奮，因為我們有潛力推進多種疾病的治療，而這些疾病目前存在著巨大的未滿足醫療需求。接下來幾分鐘，我將詳細介紹我們在愛滋病、肝病、發炎和腫瘤學方面取得的進展，並討論我們預計在 2018 年實現的一些關鍵里程碑。

Beginning with HIV. We anticipate U.S. FDA approval of BIC/F/TAF, our latest once-daily, single-tablet regimen for the treatment of HIV infection in adults, with a PDUFA date -- with PDUFA action date this coming Monday, February 12. The new drug application is supported by data from 4 ongoing Phase III studies in a total of 2,400 people, Studies 1489 and 1490 in treatment-naïve HIV infected adults and Studies 1844 and 1878 in virally suppressed adults. BIC/F/TAF met its primary objective of non-inferiority at 48 weeks across all 4 studies, and no participants failed BIC/F/TAF with treatment emergent biological resistance. Additional clinical trials of BIC/F/TAF are ongoing, including a dedicated study in women as well as a study in other [lessons] living with HIV. We plan to present data from these studies at scientific conferences in 2018.

從愛滋病毒開始。我們預計美國 FDA 將批准 BIC/F/TAF，這是我們最新的每日一次、單片療法，用於治療成人 HIV 感染，PDUFA 審批日期為下週一，即 2 月 12 日。這項新藥申請得到了 4 項正在進行的 III 期研究的數據支持，這些研究共涉及 2400 人，其中 1489 和 1490 項研究針對未經治療的 HIV 感染成年人，1844 和 1878 項研究針對病毒受到抑制的成年人。在所有 4 項研究中，BIC/F/TAF 在 48 週時達到了其主要目標，即非劣效性，並且沒有參與者因治療中出現的生物抗藥性而導致 BIC/F/TAF 治療失敗。BIC/F/TAF 的其他臨床試驗正在進行中，包括一項專門針對女性的研究以及一項針對其他 HIV 感染者的研究。我們計劃在 2018 年的科學會議上展示這些研究的數據。

We continue to invest in research for next-generation HIV therapies, including long-acting injectables for prevention and treatment, therapies for treatment-resistant patients, and approaches that could potentially cure HIV. We have filed an IND for our long-acting capsid inhibitor and plan to initiate clinical testing this quarter. With regards to HIV prevention research, we expect to have data from the DISCOVER study next year. This Phase III trial of randomized patients who received Truvada or Descovy to evaluate whether Descovy is safe and effective at reducing the risk of HIV infection when used as pre-exposure prophylaxis.

我們將繼續投資研發下一代 HIV 療法，包括用於預防和治療的長效注射劑、針對抗藥性患者的療法以及可能治癒 HIV 的方法。我們已為我們的長效衣殼抑制劑提交了IND申請，並計劃在本季度啟動臨床試驗。關於愛滋病預防研究，我們預計明年將獲得 DISCOVER 研究的數據。這項 III 期試驗隨機選取接受 Truvada 或 Descovy 治療的患者，以評估 Descovy 作為暴露前預防藥物時，在降低 HIV 感染風險方面的安全性和有效性。

Moving to NASH. There are 2 ongoing Phase III trials, STELLAR 3 and STELLAR 4, evaluating selonsertib, our ASK1 inhibitor, in patients with F3-bridging fibrosis and F4 cirrhosis. Patients with an F4 fibrosis score are at highest risk of clinical adverse events and therefore, represent the group with the greatest unmet medical need. STELLAR 4 is now fully enrolled, and STELLAR 3 will be fully enrolled in the next few months. Data will be available in 2019 and, if positive, will form the basis for our regulatory filings.

轉向NASH。目前有 2 項正在進行的 III 期試驗，即 STELLAR 3 和 STELLAR 4，正在評估我們的 ASK1 抑制劑 selonsertib 對 F3 橋接纖維化和 F4 肝硬化患者的療效。纖維化評分達到 F4 的患者發生臨床不良事件的風險最高，因此，他們是醫療需求未被滿足的最大群體。STELLAR 4 目前已全部招滿，STELLAR 3 將在未來幾個月內全部招滿。數據將於 2019 年公佈，如果結果為正面，將成為我們向監管機構提交文件的基礎。

Additionally, we're conducting small Phase II combination studies of selonsertib with Gilead's ACC inhibitor, GS-0976, and a selective nonsteroidal FXR agonist, GS-09674, in patients with NASH. Phase II data of GS-0976 in monotherapy presented at The Liver Meeting in October showed significant reduction in measures of liver fat in certain biomarkers of liver fibrosis compared to placebo. Data from these combination studies will be presented at the European Association for the Study of the Liver Annual Meeting in April, and we are in the process of initiating a larger Phase II combination study this year.

此外，我們正在對 NASH 患者進行 selonsertib 與 Gilead 的 ACC 抑制劑 GS-0976 和選擇性非類固醇 FXR 激動劑 GS-09674 的 II 期聯合治療的小規模研究。在 10 月的肝臟會議上公佈的 GS-0976 單藥治療 II 期數據顯示，與安慰劑相比，某些肝纖維化生物標記的肝臟脂肪測量值顯著降低。這些聯合研究的數據將在 4 月的歐洲肝臟研究協會年會上公佈，我們正在啟動今年更大規模的 II 期聯合研究。

We also made great progress in inflammation. Five Phase III studies of filgotinib are ongoing in patients with rheumatoid arthritis, ulcerative colitis and Crohn's disease. Three studies, FINCH 1, 2 and 3, are being conducted in rheumatoid arthritis. The FINCH 2 study is fully enrolled, and we anticipate data from this study in the second half of 2018. FINCH 2 compared filgotinib to placebo, each added to conventional disease-modifying antiarrhythmic drugs, or DMODS, in patients who have had inadequate response to biologics.

我們在發炎方面也取得了巨大進展。目前正在進行五項針對類風濕性關節炎、潰瘍性結腸炎和克隆氏症患者的filgotinib III期研究。目前正在進行三項關於類風濕性關節炎的研究，分別是 FINCH 1、2 和 3。FINCH 2 研究已完成招募，我們預計將於 2018 年下半年獲得研究的數據。FINCH 2 將 filgotinib 與安慰劑進行比較，兩者均添加到傳統的疾病修飾抗心律不整藥物（DMODS）中，用於對生物製劑反應不足的患者。

Other studies in rheumatoid arthritis include FINCH 1, a 52-week randomized study comparing filgotinib plus methotrexate to adalimumab plus methotrexate to methotrexate alone in patients who have had inadequate response to methotrexate; and FINCH 3, a 52-week randomized study comparing filgotinib alone to methotrexate alone to the combination of filgotinib plus methotrexate in methotrexate-naïve patients. We anticipate the FINCH 1 and FINCH 3 studies to be fully enrolled later this year.

其他針對類風濕性關節炎的研究包括 FINCH 1，這是一項為期 52 週的隨機研究，比較了對甲氨蝶呤反應不足的患者使用 filgotinib 加甲氨蝶呤、阿達木單抗加甲氨蝶呤和單獨使用甲氨蝶呤反應不足的患者使用 filgotinib 加甲氨蝶呤、阿達木單抗加甲氨蝶呤和單獨使用甲氨蝶呤反應不足的患者使用 FINgotinib 加甲氨蝶呤、阿達木單抗加甲氨蝶呤和單獨使用甲氨蝶呤的功效單獨治療、單獨使用甲胺蝶呤和 filgotinib 加甲胺蝶呤合併治療的療效。我們預計 FINCH 1 和 FINCH 3 研究將於今年稍後完成全部受試者招募。

Filgotinib is also being investigated in 5 additional Phase II studies in other inflammatory diseases, mainly psoriatic arthritis, ankylosing spondylitis, lupus, Sjogren's syndrome and uveitis, and we should have data available from some of these studies later this year. In addition, just last month, we filed an IND on an internally developed small molecule with a novel mechanism of action for inflammatory conditions, and we will initiate clinical development in the coming months.

Filgotinib 目前也正在 5 項針對其他發炎性疾病的 II 期研究中進行研究，主要包括乾癬性關節炎、僵直性脊椎炎、狼瘡、乾燥症和葡萄膜炎，我們應該會在今年稍後獲得其中一些研究的數據。此外，就在上個月，我們提交了一份關於一種自主研發的小分子藥物的IND申請，該藥物具有治療發炎性疾病的新型作用機制，我們將在未來幾個月內啟動臨床開發。

Moving to oncology. A randomized controlled Phase III study of andecaliximab, our anti-MMP-9 antibody, in combination with modified FOLFOX 6 in gastric cancer, is ongoing. An interim futility analysis for this study was conducted by an independent data monitoring committee in the second half of 2017, and the DMC recommended that the study continue. Additionally, we are conducting a Phase II study in gastric cancer of andecaliximab in combination with nivolumab versus nivolumab alone. This study will be completed this quarter, and we plan to present the data at a future scientific conference.

轉入腫瘤科。一項針對胃癌的隨機對照 III 期研究正在進行中，該研究評估了我們的抗 MMP-9 抗體 andecaliximab 與改良的 FOLFOX 6 方案聯合應用的療效。2017 年下半年，獨立資料監測委員會對這項研究進行了中期無效性分析，DMC 建議繼續進行這項研究。此外，我們正在進行一項 II 期研究，比較安地卡利昔單抗合併納武利尤單抗與單獨使用納武利尤單抗治療胃癌的療效。這項研究將於本季完成，我們計劃在未來的科學會議上展示研究數據。

In cell therapy, long-term data from our pivotal ZUMA-1 study of Yescarta in patients with refractory large B cell lymphoma were presented at the American Hematology Society Meeting and published concurrently in the New England Journal of Medicine in December. In this updated analysis, with a median -- minimum follow-up of 1 year and a median follow-up of 15.4 months, after a single infusion of Yescarta, 42% of the patients continued to respond to therapy, with 40% continuing to have a complete response. We anticipate having 2-year data from the ZUMA-1 study later this year.

在細胞治療方面，我們針對難治性大B細胞淋巴瘤患者進行的關鍵性ZUMA-1研究的長期數據已在美國血液學會會議上公佈，並於12月同時發表在《新英格蘭醫學雜誌》上。在這項更新的分析中，中位追蹤時間為 1 年（最低）和 15.4 個月（中位追蹤時間），在單次輸注 Yescarta 後，42% 的患者繼續對治療有反應，其中 40% 的患者繼續有完全緩解。我們預計將於今年稍後獲得 ZUMA-1 研究的 2 年數據。

Additional studies are underway, including ZUMA-7, a Phase III randomized study comparing Yescarta to the standard of care in second-line treatment of patients with diffuse large B cell lymphoma. Data are expected in 2020. Also underway is ZUMA-6, a Phase I/II combination study of Yescarta with atezolizumab, an anti-PD-L1 antibody; and a Phase I study of KITE-585, a CAR-T T-cell therapy engineered to target B cell maturation antigen in patients with relapsed or refractory multiple myeloma.

目前還有其他研究正在進行中，包括 ZUMA-7，這是一項 III 期隨機研究，旨在比較 Yescarta 與標準療法在瀰漫性大 B 細胞淋巴瘤患者二線治療中的療效。預計數據將於2020年公佈。目前正在進行的還有 ZUMA-6，這是 Yescarta 與抗 PD-L1 抗體 atezolizumab 聯合用藥的 I/II 期研究；以及 KITE-585 的 I 期研究，這是一種 CAR-T T 細胞療法，旨在靶向復發或難治性多發性骨髓瘤患者的 B 細胞成熟抗原。

Phase I results from the ZUMA-3 study of KTE-C19 in 24 adults with relapsed or refractory B cell acute lymphoblastic leukemia were also presented at ASH. KTE-C19 is the same anti-CD19 CAR-T construct as axi-cel but is manufactured through a slightly different process. With a minimum of 8 weeks of follow-up, 17 of the 24 participants will receive the single infusion of KTE-C19 that should achieve complete remission and 21 of the 24 participants had no detectable disease.

在 ASH 大會上也公佈了 KTE-C19 對 24 名復發或難治性 B 細胞急性淋巴性白血病成年患者進行的 ZUMA-3 研究的 I 期結果。KTE-C19 與 axi-cel 是相同的抗 CD19 CAR-T 構建體，但其生產過程略有不同。經過至少 8 週的隨訪，24 名參與者中有 17 名將接受 KTE-C19 的單次輸注，應該可以達到完全緩解，24 名參與者中有 21 名沒有檢測到疾病。

I hope I've conveyed my excitement about the pipeline programs we have across Gilead's therapeutic areas. In summary, pending the results of ongoing studies that will read out in 2018 and 2019, we could be in a position to file as many as 4 NDAs or BLAs next year.

我希望我已經表達了我對吉利德各個治療領域在研計畫的興奮之情。總而言之，根據 2018 年和 2019 年公佈的正在進行的研究結果，我們明年可能可以提交多達 4 份 NDA 或 BLA 申請。

I would now like to turn over the call to John. John?

現在我想把電話交給約翰。約翰？

Thanks, Norbert. I'd like to make a few comments about the year that has just ended and where we will focus in 2018.

謝謝你，諾伯特。我想就剛剛過去的一年以及我們2018年的工作重點談談幾點看法。

As Robin mentioned, Yescarta was approved by the FDA in October of 2017. We're greatly encouraged by the initial response we have seen from the health care and patient communities in recognition of the lifesaving potential for people with aggressive large B cell lymphoma who have run out of options. We have authorized 28 cancer centers to date, and each center is now certified to administer Yescarta to patients. Given the promise of Yescarta and the significant patient need, we're actively working on training and certifying additional centers on the risk, evaluation and mitigation strategy and the Kite Konnect process.

正如 Robin 所提到的，Yescarta 於 2017 年 10 月獲得 FDA 批准。我們對醫療保健界和患者群體的初步反應感到非常鼓舞，他們認識到這種療法對於患有侵襲性大B細胞淋巴瘤且已無其他治療選擇的患者來說具有挽救生命的潛力。到目前為止，我們已經授權了 28 個癌症中心，每個中心現在都獲得了為患者使用 Yescarta 的認證。鑑於 Yescarta 的前景和患者的巨大需求，我們正在積極努力培訓和認證更多中心，使其掌握風險評估和緩解策略以及 Kite Konnect 流程。

By mid-2018, we anticipate there'll be enough centers certified to treat 80% of Yescarta-eligible patients. We're very excited about the present opportunity with Yescarta, and as Norbert mentioned, we're enrolling clinical studies to expand the label to earlier lines of therapy and exploring combination therapy with other immuno-oncology agents.

到 2018 年年中，我們預計將有足夠的中心獲得認證，能夠治療 80% 符合 Yescarta 治療條件的患者。我們對 Yescarta 目前的發展機會感到非常興奮，正如 Norbert 所提到的，我們正在進行臨床研究，以擴大其適應症範圍，用於更早期的治療，並探索與其他免疫腫瘤藥物的聯合治療。

We are also working to improve CAR-T therapies and are acquiring next-generation technology in the belief that we will be able to develop cellular therapies that can achieve greater responses, lessen side effects and increase the types of malignancies that can be treated. For example, the acquisition of Cell Design Labs gives us access to proprietary technology platforms that will augment and accelerate these efforts, along with a dedicated research team who, in collaboration with the Kite team, will help us drive next-generation CAR-T therapies into the clinic more quickly. The future is incredibly bright for cellular therapy, and we're very excited to be at the forefront of the field.

我們也在努力改進 CAR-T 療法，並正在獲取下一代技術，相信我們將能夠開發出能夠獲得更大療效、減少副作用並增加可治療惡性腫瘤類型的細胞療法。例如，收購 Cell Design Labs 使我們能夠獲得專有技術平台，這將增強和加速這些努力，同時我們還擁有一支專門的研究團隊，他們將與 Kite 團隊合作，幫助我們更快地將下一代 CAR-T 療法推向臨床。細胞療法的未來前景非常光明，我們很榮幸能站在這領域的前端。

Over the past 3 decades, Gilead's relentless scientific pursuit of better HIV treatments has led to a range of options to help address the diverse needs of people living with HIV. Once approved, BIC/F/TAF will offer people an important new single-tablet regimen option, both for those newly diagnosed with HIV and those who may desire or need to switch from their current multi-tablet regimen or single-tablet regimen. BIC/F/TAF represents Gilead's sixth single-tablet regimen, and with the approval of SYMTUZA in the EU by our partner, Janssen, the fourth containing TAF.

過去三十年來，吉利德公司孜孜不倦地追求更好的 HIV 治療方法，已經開發出一系列方案，以幫助滿足 HIV 感染者的各種需求。一旦獲得批准，BIC/F/TAF 將為人們提供一種重要的全新單片療法選擇，既適用於新確診的 HIV 感染者，也適用於那些希望或需要從目前的多片療法或單片療法轉換而來的人。BIC/F/TAF 代表吉利德的第六種單片療法，隨著我們的合作夥伴楊森在歐盟批准 SYMTUZA，這是第四種含有 TAF 的療法。

With the approval of BIC/F/TAF, there'll be TAF-containing single-tablet regimens available for patients containing each of the major third agents, including unboosted and boosted integration inhibitors, a boosted protease inhibitor and an NNRTI. We are deeply committed to continuing to innovate in the field of HIV treatment, particularly for the population of people who've been living with HIV for a long time and whose treatment needs have changed as they have aged.

隨著 BIC/F/TAF 的批准，將有含有 TAF 的單片複方製劑可供患者使用，其中包含每種主要的第三種藥物，包括未增強和增強的整合抑製劑、增強的蛋白酶抑製劑和 NNRTI。我們致力於在愛滋病治療領域不斷創新，特別是針對那些長期感染愛滋病毒且隨著年齡增長治療需求而改變的人。

The advancement of clinical trials for selonsertib and filgotinib has positioned Gilead as a leader in NASH and inflammatory diseases. In NASH, the rapid enrollment of patients has put Gilead in the lead in the development of treatments for patients with the most severe form of the disease. If selonsertib clinical studies read out positively in early 2019, Gilead will then be in a position to launch the first therapy for NASH in 2020.

塞隆塞替尼和菲戈替尼的臨床試驗進展使吉利德成為 NASH 和發炎性疾病領域的領導者。在 NASH 領域，患者的快速入組使吉利德在開發治療最嚴重 NASH 患者的療法方面處於領先地位。如果 selonsertib 的臨床研究在 2019 年初取得正面成果，吉利德公司將在 2020 年推出首個 NASH 療法。

We continue to be enthusiastic about filgotinib. In the ongoing Phase III studies, we are looking to see if the potential safety and efficacy advantages of a selective JAK1 inhibitor seen in preclinical and early clinical studies are borne out in these trials. In addition, Gilead's exploring 5 additional indications beyond rheumatoid arthritis, ulcerative colitis and Crohn's disease.

我們依然對filgotinib充滿熱情。在正在進行的 III 期研究中，我們正在尋找在臨床前和早期臨床研究中觀察到的選擇性 JAK1 抑制劑的潛在安全性和有效性優勢是否能在這些試驗中得到證實。此外，吉利德公司正在探索除類風濕性關節炎、潰瘍性結腸炎和克隆氏症之外的 5 個其他適應症。

As we enter 2018, we see that the market dynamics in HCV are stabilizing. Since the launch of sofosbuvir in 2013, we've seen multiple competitors come to market, and we've launched 3 of our own new HCV therapies. With the launch of each new product -- the launch of each new product was disruptive, leading to lower prices and shortened treatment duration, both highly beneficial to patients and payers. Going forward, we don't see any new HCV product launches disrupting the market. This leaves 2 remaining variables: the number of patients who start therapy each year and market share versus our competitors. As Robin mentioned, we expect patient starts to continue to decline, although more slowly than in the past. Market share versus our competitors is expected to stabilize by the middle of this year.

進入 2018 年，我們看到C型肝炎病毒的市場動態趨於穩定。自 2013 年索非布韋上市以來，我們看到許多競爭對手進入市場，而我們也推出了 3 種我們自己的新型 HCV 療法。每款新產品的推出都具有顛覆性，導致價格降低、治療時間縮短，這對患者和支付者都非常有利。展望未來，我們預計不會有任何新的C型肝炎產品上市，從而擾亂市場。這樣就剩下兩個變數：每年開始接受治療的患者人數以及與競爭對手相比的市場份額。正如羅賓提到的那樣，我們預計患者數量將繼續下降，儘管下降速度會比過去慢一些。預計到今年年中，我們與競爭對手的市佔率將趨於穩定。

Given these changes, Gilead's HCV revenues should be a more predictable, albeit smaller piece of our financial story. By removing most of the overhang of declining HCV revenues going forward, we can focus on the positive financial trends driven by the continued uptake of TAF-containing regimens and short-term and long-term growth via Yescarta, selonsertib and filgotinib.

鑑於這些變化，吉利德的丙型肝炎收入應該會更加可預測，儘管在我們財務故事中所佔的份額會更小。透過消除 HCV 收入持續下降的大部分不利因素，我們可以專注於由含 TAF 療法的持續推廣以及 Yescarta、selonsertib 和 filgotinib 帶來的短期和長期增長所驅動的積極財務趨勢。

We have been open about our desire to increase our pipeline through acquisitions and partnerships with other companies as we continue to actively seek new therapeutic advancements and technologies. We have both the financial strength and internal capability to aggressively pursue opportunities when we see them.

我們一直公開表示，希望透過收購和與其他公司合作來增加我們的產品線，同時我們將繼續積極尋求新的治療方法和技術。我們擁有雄厚的財力和內部能力，能夠在機會出現時積極掌握。

I am more excited than ever about the future of Gilead as we extend our efforts to help new groups of people with difficult diseases. I would like to take this opportunity to thank our employees for their dedication and service. It's because of your belief in our mission that we're able to reach millions of people with our lifesaving medicines.

隨著我們不斷努力幫助更多患有疑難雜症的人群，我對吉利德的未來比以往任何時候都更有信心。我想藉此機會感謝我們員工的奉獻和服務。正是因為你們相信我們的使命，我們才能將拯救生命的藥物帶給數百萬人。

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

感謝您今天抽出時間，現在我們開始接受提問。操作員？

(Operator Instructions) And our first question comes from Geoff Meacham of Barclays.

（操作員說明）我們的第一個問題來自巴克萊銀行的傑夫·米查姆。

So John, when I look at hep C trends, which could trough this year and they're offset by a positive impact from HIV Yescarta in the pipeline, it looks like you guys could get back to growth exiting this year and maybe even going into 2019. How important is that to Gilead overall? Or do you view these franchises and moving parts more independently?

所以約翰，我觀察丙肝的趨勢，雖然它可能會在今年觸底，但被正在研發中的 HIV Yescarta 的積極影響所抵消，看起來你們今年年底甚至 2019 年都可能恢復增長。這對吉利德公司整體而言有多重要？還是您更獨立地看待這些特許經營權和運作環節？

Thanks, Geoff. Thanks for the question. So of course, we view all of our franchises independently, but taken as a whole, that makes Gilead. And so we do think that it's important that we're able to stabilize HCV revenues, and it's important that we be able to talk about the company with the future dynamics that I think will drive us. We're clearly very excited about TAF-based regimens. We're very eager to get bictegravir F/TAF launched. That will be another positive momentum going forward. As Norbert mentioned, we could file up to 4 NDA and BLAs going forward. So I think after years of having to be defensive about HCV revenues declining, it's very nice to be on the other side of that and talk about the positive trends going forward, and we hope that, that will dominate the conversation throughout the year, much as it did through -- at the beginning of the year beginning with JPMorgan.

謝謝你，傑夫。謝謝你的提問。所以，我們當然會獨立看待我們所有的特許經營權，但作為一個整體，它就構成了基列國。因此，我們認為穩定 HCV 收入非常重要，我們能夠談論公司未來的發展動態也很重要，我認為這些動態將推動我們前進。我們對基於 TAF 的治療方案顯然感到非常興奮。我們非常渴望推出比克替拉韋F/TAF。這將為未來的發展帶來另一個正面的動力。正如諾伯特所提到的，我們接下來最多可以提交 4 份 NDA 和 BLA 申請。所以我覺得，在多年來不得不為 HCV 收入下降而辯解之後，很高興能夠擺脫這種困境，談論未來的積極趨勢，我們希望這能成為全年討論的焦點，就像年初摩根大通的案例一樣。

And our next question comes from Michael Yee of Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

Following along that, I guess, when you think about the slope of your revenues this year and your commentary about stabilization, thinking about the decline of hep C in the first half of the year and revenue growth with the other products, do you think that you would trough out this year and that you do see yourself as a growing product franchise by the end of this year?

由此看來，考慮到今年的收入成長趨勢以及您對穩定化的評論，考慮到上半年丙肝業務的下滑以及其他產品的收入增長，您認為您今年能夠渡過難關嗎？您是否認為到今年年底，您的產品特許經營權將會持續成長？

Michael, this is Robin. I mean, yes, as John mentioned and I mentioned, we do see the HCV market dynamic stabilizing. And removing that overhang, we do think that with our new HIV STR launch of bictegravir -- or BIC/F/TAF as well as our other franchise that we do overall see ourselves as a growth story. Even if you look at Page 34 in our guidance, you can see overall our HCV franchise is expected to grow, and that's growth along with the LOE ex U.S. as well as to take into account our other franchise with Letairis, we're still showing overall growth in those core franchises over and above hepatitis C.

邁克爾，這位是羅賓。我的意思是，是的，正如約翰和我所提到的那樣，我們確實看到C型肝炎病毒市場動態趨於穩定。消除了這一不利因素，我們認為，隨著我們新推出的 HIV STR 藥物比克替拉韋（或 BIC/F/TAF）以及我們的其他特許經營權，我們總體上認為自己是一個增長的故事。即使查看我們的指導文件第 34 頁，您也可以看到，總體而言，我們的 HCV 特許經營業務預計會增長，這包括美國以外的 LOE 業務的增長，以及考慮到我們與 Letairis 的其他特許經營業務，我們仍然顯示，除了丙型肝炎業務之外，這些核心特許經營業務的整體增長也超過了丙型肝炎業務。

And our next question comes from Brian Abrahams of RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的布萊恩亞伯拉罕。

In the CAR-T space, obviously, we've seen some consolidation lately. I'm just curious, coming out of the CDL acquisition now, where should we look for your focus of investments going forward in technology enhancements that are going to be the most important for long-term competitive positioning, enhancement of delivery and expansion into additional populations from here?

在 CAR-T 領域，我們最近顯然看到了一些整合。我很好奇，在完成對 CDL 的收購之後，未來在技術改進方面的投資重點應該放在哪裡？這些技術改進對於長期競爭地位、提升服務水準以及拓展到更多人群至關重要。

Brian, it's John. So just a couple of comments on where we're going to go next. So without giving you any specifics, we have been fairly open in our conversations that we do think that there are additional technologies we want to use to enhance the capabilities we have, including gene editing technology. That's something we've talked about previously. Obviously, there are several areas where we want to try to figure out where we can be more effective. One is increasing the number of targets so we can go out, so we're looking at additional targets. We are looking at ways that we can perhaps move from autologous to allogeneic or sort of universal donor CAR-Ts, so that's technology that Kite was working on and that we will continue to work on. Gene editing plays into that in some areas. And then, of course, anything that we could use to try to lessen the side effects of CAR-T would be important to us. So we're looking at technologies, thoughts on how we could have, perhaps, a lower cytokine release syndrome, perhaps decrease the neurotoxicity associated with it. So all of these things are important to us, and we're very, very actively looking at these technologies right now.

布萊恩，我是約翰。接下來，我想就我們的下一步計畫做幾點說明。因此，雖然我們不透露具體細節，但我們在交流中相當坦誠地表示，我們認為還有一些其他技術可以增強我們現有的能力，包括基因編輯技術。我們之前討論過這個問題。顯然，我們希望在幾個方面找出可以提高效率的方法。一是增加目標數量，以便我們能夠外出行動，所以我們正在尋找更多目標。我們正在研究如何從自體 CAR-T 療法過渡到異體 CAR-T 療法或通用捐贈者 CAR-T 療法，這是 Kite 一直在研究的技術，也是我們將繼續研究的技術。基因編輯在某些領域發揮了作用。當然，任何能夠減輕 CAR-T 療法副作用的方法對我們來說都非常重要。所以我們正在研究各種技術，思考如何降低細胞激素釋放症候群的發生率，或許也能降低與之相關的神經毒性。所以所有這些對我們來說都很重要，我們目前正在非常積極地研究這些技術。

And our next question comes from Robyn Karnauskas of Citi.

下一個問題來自花旗銀行的 Robyn Karnauskas。

So when -- if I remember correctly, back when you used to launch HIV products, it would take a long time to get on the guidelines and this is a guideline-driven market. And then with Genvoya, that was extremely different. Do you have any sense with BIC/F/TAF whether or not we could see that hitting the guidelines sooner than expected? What motivated the guidelines to change so quickly with Genvoya?

所以，如果我沒記錯的話，以前你們推出 HIV 產品的時候，要符合指導方針需要很長時間，而這是一個以指導方針為導向的市場。而 Genvoya 的情況則截然不同。您認為BIC/F/TAF是否有可能比預期更早達到指導方針？是什麼原因促使 Genvoya 的相關指引如此迅速地改變？

Robyn, it's Andrew Cheng speaking. So I think you're right. When we look back at the time that Genvoya was put on the DHHS guidelines in less than 2 weeks after approval, I think as it's difficult to surmise what drove them to do that. But one can take a look at the clinical profile and the differentiation versus TDF-based regimens that we saw in our registrational package, and that may have played a role in that. In terms of the role of BIC/F/TAF one thinks going forward, I think continue what we've seen already with TAF-based regimens and how they've impacted HIV treatments throughout the United States, it seems reasonable that these will be adopted in the guidelines. Now, the time lines of which are, as you're driving it, are difficult to say. I think that we don't want to overcommit in terms of -- they have a process in place, and we look forward to working with them to get the BIC/F/TAF on the guidelines as soon as possible.

Robyn，我是Andrew Cheng。所以我覺得你是對的。回顧 Genvoya 在獲得批准後不到 2 週就被列入 DHHS 指南的這段時間，我認為很難推測是什麼促使他們這樣做。但我們可以看看我們在註冊資料包中看到的臨床概況以及與基於 TDF 的方案的差異，這可能對此起到了一定作用。就 BIC/F/TAF 的作用而言，我認為，鑑於我們已經看到的基於 TAF 的治療方案以及它們對全美 HIV 治療的影響，這些方案被納入指南似乎是合理的。現在，在你駕駛的過程中，很難說出具體的時間線是什麼。我認為我們不想在這方面做出過多的承諾——他們已經制定了流程，我們期待與他們合作，盡快讓 BIC/F/TAF 參與指導方針中來。

Robyn, I would like to reiterate what Andrew said. It used to take a long time many years ago. But in the case of Genvoya, it took exactly 2 weeks. So it's not true anymore that it takes a long time to get on the guidelines.

羅賓，我想重申安德魯剛才說的話。很多年前，這需要很長時間。但就 Genvoya 而言，它花了整整 2 週。所以，不再是需要很長時間才能符合指導方針的說法了。

Yes, it is a more dynamic process, and of course, we also benefit that F/TAFs are viewed very favorably within the guidelines. And so that is a big help for us as we launch BIC/F/TAF.

是的，這是一個更具動態性的過程，當然，我們也受益於 F/TAF 在指導方針中受到非常有利的評價。因此，這對我們推出 BIC/F/TAF 來說是一個很大的幫助。

And our next question comes from Geoffrey Porges of Leerink.

下一個問題來自 Leerink 公司的 Geoffrey Porges。

I'll just ask a couple of related questions below the line, if I may, Robin. Your tax outlook is significantly better than we expected and that you've had before. Can you tell us what your view of the sustainability of that tax rate? And as you move capital onshore and invest in manufacturing, can that come down any further from the range you're indicating for 2018? And then a similar question just related about operating margins. Looks like you're guiding to about 50% in 2018. Is that a stable number? Or do you think that, that could come under further pressure as you ramp up R&D?

羅賓，如果可以的話，我想在下面問幾個相關的問題。您的稅務前景比我們預期的以及您以往的情況都要好得多。您能否談談您對稅率可持續性的看法？隨著資本轉移到國內並投資製造業，2018 年的通膨率還能比您預測的水準進一步下降嗎？然後還有一個類似的問題，只是與營業利益率有關。看來你們預計2018年將達到50%左右。這是一個穩定的數字嗎？或者您認為，隨著研發投入的增加，這種情況可能會面臨更大的壓力嗎？

Sure, Geoff. So to answer your first question, I do believe the range that I provided for you for tax rates are stable. I don't know if it's -- it's not necessarily the overall mix per se of our revenue. To some extent, it is that, but I think with that lower U.S. tax rate and the fact that we've already seen a significant mix shift because of our HCV revenue declining, more revenues in the U.S., I do believe that's sustainable longer term. It's very fortuitous for us from a timeframe standpoint because with that shift, our rate would have creeped up pretty significantly in 2018 compared to 2017.

當然可以，傑夫。所以，回答你的第一個問題，我認為我提供給你的稅率範圍是穩定的。我不知道是不是——這不一定是我們收入的整體組成。在某種程度上確實如此，但我認為，鑑於美國較低的稅率，以及由於HCV收入下降，我們已經看到收入結構發生了顯著變化，美國的收入更多，我相信這種情況在長期內是可持續的。從時間角度來看，這對我們來說非常幸運，因為如果發生這種轉變，我們的利率在 2018 年將比 2017 年大幅上升。

Relative to operating margins, I'd say we're a little higher than you project overall, but still remaining industry leading. I do feel that 50% plus is sustainable for us. We are in investment mode when you think about R&D, et cetera, so -- and we're several large Phase III trials, launching BIC/TAF, but obviously a lot of incremental opportunities going forward. So I would say, yes, sustainable, and I think we'd aspire to see it even rise higher over time.

就營業利潤率而言，我認為我們總體上比您預期的略高一些，但仍然保持行業領先地位。我認為50%以上的成長率對我們來說是可持續的。我們目前處於研發等方面的投資模式，所以——我們正在進行幾項大型 III 期試驗，推出 BIC/TAF，但顯然未來還有很多增量機會。所以我會說，是的，這是可持續發展的，而且我認為我們希望看到它隨著時間的推移而不斷提高。

And our next question comes from Matthew Harrison of Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

Norbert, I wanted to ask you a question on NASH. You highlighted both the STELLAR studies and the ACC, but you didn't talk a lot about the FXR. In your slides here, it says you had an interim on PBC, and you completed the Phase II NASH study. Any comments on the profile there, if that's panning out as you had expected with lower rates of itching and some other differentiation versus some of the competitors in the market?

Norbert，我想問你一個關於 NASH 的問題。你重點介紹了 STELLAR 研究和 ACC，但你沒有太多談到 FXR。你的幻燈片中提到，你對 PBC 進行了中期研究，並且完成了 NASH II 期研究。關於該產品的成分分析，您有什麼看法？它是否如您預期那樣，在降低搔癢發生率以及與其他一些市場競爭對手相比具有差異化優勢方面取得了成功？

Matt, thanks for the question. So the reason is simply that the FXR agonists is somewhat behind the ACC inhibitor. We will present -- so the Phase II result studies are just ramping up. We're looking at the data, and we intend to submit this to an upcoming conference, Liver Conference. You will then see the results. So just to remind you with our FXR agonist, the hypothesis was that we don't want a high oral exposure -- high systemic exposure with the FXR agonist. So it got restricted or got focused mechanism of action that releases [AGF 19] that then goes into the circulation and does -- provides the efficacy. So you will see the completed Phase II study at an upcoming conference.

馬特，謝謝你的提問。所以原因很簡單，FXR激動劑的療效略遜於ACC抑制劑。我們將進行展示－目前二期臨床試驗結果正在逐步公佈。我們正在研究這些數據，並打算將其提交給即將召開的肝病學會議。然後您將看到結果。所以，提醒一下，對於我們的 FXR 激動劑，我們的假設是，我們不希望 FXR 激動劑的口服暴露量過高，導致全身暴露量過高。因此，它的作用機制受到限製或集中，釋放[AGF 19]，然後進入血液循環並發揮功效。所以您將在即將召開的會議上看到完整的二期研究報告。

And our next question comes from Phil Nadeau of Cowen & Company.

下一個問題來自 Cowen & Company 的 Phil Nadeau。

I had a question on shifting market share in both HIV and HCV. So in HCV, you talk about a $4.3 billion to $4.6 billion year-over-year decrease because of competitive issues. Can you give us some idea of what type of share shift you anticipate in that guidance? And then similarly, in HIV, you talk about a $1.2 billion to $1.5 billion increase. What type of share do you think you'll be able to take back with the bictegravir combination pill? And what's assumed in that guidance?

我有一個關於愛滋病毒和丙型肝炎市場份額變化的問題。因此，在丙型肝炎領域，由於競爭問題，預計將年減 43 億至 46 億美元。您能否大致說明一下您預期該指引中會出現怎樣的份額變化？同樣，在愛滋病方面，你們說會增加 12 億至 15 億美元。你認為服用比克替拉韋複方片後，你能拿回多少股份？該指導意見基於哪些假設？

Phil, maybe I'll cover HCV and I'll have John cover HCV. But as we said, I think we -- if you compare and take a look at our Q4 revenues of $2.3 billion relative to all the other players, our share is -- we've done very well, and in 2018, it's reflective of that continued market share position. I don't want to get into specific percentages, and I think there will be puts and takes across the various markets, but we are very confident that with our product portfolio that we believe we can maintain market leadership position. In the U.S., the market has moved towards more parity access, which we'd prefer because it really leaves the prescribing decisions with doctors and patients, and we have been able to maintain parity or preferred access across the majority of accounts overall. So we believe that, yes, we think our share position bodes very well for 2018.

菲爾，或許我會負責C型肝炎的治療，然後讓約翰也負責C型肝炎的治療。但正如我們所說，我認為——如果你比較一下我們第四季度 23 億美元的收入與其他所有競爭對手相比，我們的份額——我們做得非常好，2018 年，這反映了我們持續的市場份額地位。我不想透露具體的百分比，而且我認為各個市場都會有漲跌起伏，但我們非常有信心，憑藉我們的產品組合，我們能夠保持市場領先地位。在美國，市場已經朝著更平等的獲取途徑發展，我們更傾向於這種發展，因為它真正將處方決定權留給了醫生和患者，而且我們已經能夠在大多數帳戶中保持平等或優先的獲取途徑。所以我們相信，是的，我們認為我們的持股預示著2018年將取得非常好的成績。

Phil had a 2-part question, so I'll answer the HIV question. So you asked about market share for HIV. I will say that I'm going to not talk about market share specifically, but I can tell you, in the U.S., we expect to maintain our market share. There are obviously some changes due to generic TDF in the United States. I don't think that will affect us very much as Truvada is still protected. We do think that we can gain that growth that you mentioned through switches from protease inhibitors and some multi-tablet regimens and, of course, switches from single-tablet regimens. So we think there's enough switching business and enough treatment-naïve business in there for bictegravir and additional growth in Genvoya that will do quite well in those areas.

Phil 的問題分成兩個部分，所以我先回答 HIV 的問題。所以你問的是愛滋病毒的市場佔有率。我不會具體談論市場份額，但我可以告訴你們，在美國，我們預計會保持我們的市場份額。由於美國出現了仿製藥TDF，顯然發生了一些變化。我認為這不會對我們造成太大影響，因為 Truvada 仍然受到保護。我們認為，透過從蛋白酶抑制劑和一些多片藥方案中轉換，當然還有從單片藥方案中轉換，我們可以獲得您提到的那種增長。因此，我們認為，對於比克替拉韋而言，轉換治療業務和未經治療的患者業務都足夠多，而 Genvoya 的進一步增長在這些領域將會表現相當不錯。

In the United -- or sorry, in the European Union, however, we do think, with the generic -- entry of generics in 2018, both TDF and TDF/FTC and, of course, TDF/FTC/efavirenz, as Robin mentioned, that we will see some temporary decrease in market share. And then long-term growth getting beyond this year due to the approvals of B/F/TAF, BIC/F/TAF, which will occur later in the year, allowing us to launch in these various countries. As we mentioned, in some of our sites, we have seen incredible uptake of both Descovy and Genvoya across parts of the European Union. I think that bodes very well long term for TAF regimens. And so we're very, very enthusiastic and confident about that franchise there.

然而，在美國——或者抱歉，是在歐盟——我們認為，隨著仿製藥在 2018 年進入市場，包括 TDF 和 TDF/FTC，當然還有 TDF/FTC/依非韋倫（正如 Robin 所提到的），我們將看到市場份額出現一些暫時的下降。然後，由於 B/F/TAF 和 BIC/F/TAF 的批准（將於今年稍後進行），長期成長將持續到今年以後，這將使我們能夠在這些不同的國家推出產品。正如我們之前提到的，在我們的一些站點，我們在歐盟部分地區看到了 Descovy 和 Genvoya 的驚人普及率。我認為這對TAF療法的長期發展來說是一個非常好的兆頭。因此，我們對那裡的特許經營權感到非常、非常熱情和充滿信心。

And our next question comes from Umer Raffat of Evercore.

我們的下一個問題來自 Evercore 公司的 Umer Raffat。

Norbert, I wanted to drill down your STELLAR 4 trial in NASH. And my question is, what do you expect the placebo arm to track at on the percentage of patients that will have a 1-stage improvement? And I'm also curious what level of visibility do you have on the ongoing STELLAR 3 and STELLAR 4 trials on the pooled event rate on a blinded basis?

Norbert，我想深入了解你在 NASH 的 STELLAR 4 試驗。我的問題是，您預計安慰劑組中達到 1 級改善的患者百分比會是多少？另外，我還想了解一下，您對正在進行的 STELLAR 3 和 STELLAR 4 試驗中，在盲法條件下匯總事件發生率的了解程度如何？

So Umer, the only thing I can point to is the Phase II study that we have done. I think I'm very confident we will repeat those numbers. Of course, they won't be exactly the same. As you may remember, the end -- the total end was somewhat small, but we saw a difference between placebo and the high-dose active arm of 20%. And that would be -- we will be very happy with that because, as you know, the endpoint is fibrosis. Something that improves fibrosis or prevents fibrosis progression, that will be a tremendous asset and contribution to the health care system. So the other study I can tell you. We, of course, are looking in an ongoing blinded way at safety. And I can tell you, the compound is very safe. We are not seeing anything that will concern us, either laboratory abnormalities or adverse events or discontinuation rates. But having that said, I want to make sure that everybody understands. We're blinded to the study, so it's a placebo-controlled study. But in the blinded data set, there's nothing that will concern us.

所以，Umer，我唯一能指出的就是我們已經完成的第二期研究。我認為我們非常有信心能夠再次取得這樣的成績。當然，它們不會完全相同。您可能還記得，最終結果——總結果雖然不大，但我們發現安慰劑組和高劑量活性組之間存在 20% 的差異。那將是——我們會非常高興的，因為，如你所知，最終結果是纖維化。能夠改善纖維化或阻止纖維化進展的療法，將是醫療保健系統的巨大財富和貢獻。至於另一項研究，我可以告訴你。當然，我們一直以來都以一種盲目的方式看待安全問題。我可以告訴你，這種化合物非常安全。我們沒有發現任何令人擔憂的情況，無論是實驗室異常、不良事件或停藥率。但話雖如此，我還是想確保每個人都能理解。我們對這項研究並不知情，所以這是一項安慰劑對照研究。但在經過盲化處理的資料集中，沒有什麼值得我們擔心的。

And our next question comes from Terence Flynn of Goldman Sachs.

下一個問題來自高盛的特倫斯·弗林。

Maybe just one from me on Yescarta. Just wondering if you can talk to us about how important being first to market is and your view given potential entry of a third player next year. And then in your guidance, can you give us any color in terms of what you assume for kind of second half of the year on Yescarta? Is there an inflection or a step-up? Or should we just kind of assume a kind of steady-eddy here?

或許我會在 Yescarta 上發布一條。我想請您談談搶佔市場先機的重要性，以及考慮到明年可能有第三家競爭對手進入市場，您對此有何看法。那麼，根據您的指導，您能否就 Yescarta 今年下半年的發展前景給予一些預測？是否存在轉折點或階躍？或者我們應該假設這裡存在某種穩定的渦流？

I do think first mover is very important with this area because it allows us to develop this rapport and relationship with the different cancer centers. And so I think a first mover advantage is important in this area. I'm not going to say that it's everything, but of course, we have a second entry and then a third entry. You leaped right to the third, but we're expecting a second entry, of course, in Novartis. And so I do think that is important so that we have the connectivity, we get through the paperwork, the REMS program. I mean, this has to be duplicated for each individual agent coming to market. And so it is more difficult to get the attention of the centers once they have something that works very, very well, which we hope they believe they have in Yescarta. So I think that is an important thing to consider.

我認為在這個領域搶佔先機非常重要，因為它使我們能夠與不同的癌症中心建立融洽的關係。所以我認為，在這個領域，先發優勢非常重要。我不會說這就是全部，但當然，我們還有第二筆記錄，然後是第三筆記錄。你直接跳到了第三名，但我們當然期待諾華公司能入選第二名。所以我認為這很重要，這樣我們才能建立聯繫，完成文書工作，完成 REMS 計劃。我的意思是，對於每個進入市場的經紀人來說，這都需要重複。因此，一旦中心擁有了非常非常有效的方法，就更難引起他們的注意，我們希望他們相信 Yescarta 就是這樣一種方法。所以我認為這是需要考慮的重要因素。

You mentioned an inflection point, and as we mentioned on the call, we are now getting centers up and running. We have 28 centers currently that are up and now certified to prescribe Yescarta. We hope to have about 80% of the population by the midpoint in this year. And so I think what we're seeing with each center is, as they get better at handling both the patients and the payment aspect of this because that is a negotiation between the center and the payers themselves, as they get that down, it gets easier to bring in new patients. And so we do see a slowly growing momentum in each center as they get up and going. So obviously, the second half of the year will be a lot better for enrolling patients than the first half of this year, but I don't see a major inflection point but just a growing, building of patients over time. So that as we exit 2018, we should have a pretty good handle on what the typical flow rate at each center is and what they can handle.

您提到了一個轉折點，正如我們在電話會議中提到的，我們現在正在讓各個中心投入運作。目前我們有 28 個中心已投入運作並獲得認證，可以開立 Yescarta 處方。我們希望到今年年中時，人口能夠恢復到原來的80%左右。所以我認為我們看到的是，每個中心在處理患者和支付方面都做得越來越好，因為這是中心和支付方之間的談判，當他們把這些方面處理好之後，就更容易招攬新患者了。因此，我們看到每個中心都在逐步發展壯大，勢頭也逐漸增強。顯然，今年下半年招募患者的情況會比上半年好得多，但我認為不會出現重大轉折點，患者數量只會隨著時間的推移而增長和累積。這樣，到 2018 年結束時，我們應該能夠很好地掌握每個中心的典型流量以及它們能夠處理的情況。

And our next question comes from Alethia Young of Credit Suisse.

下一個問題來自瑞士信貸的阿萊西亞·楊。

Just one on bictegravir switches. I know Atripla is still the #3 regimen in the United States. So I guess I'm trying to figure out, like, is it more an education with the doctors? Or is it finding the patients and bringing them back to therapy to encourage them to move to bictegravir versus Atripla?

只有一個在比克特格拉維爾開關上。我知道 Atripla 仍然是美國排名第三的治療方案。所以我想弄清楚的是，這更像是一種向醫生學習的過程嗎？或者，是否應該找到患者並讓他們重新接受治療，以鼓勵他們改用比克替拉韋而不是阿特瑞普拉？

So Alethia, it's Andrew. So I think it's a combination. When you look at the registrational studies that support the filing package, we've had patients who were switching from protease-based inhibitors or multi-tablet regimens and which are -- and keep in mind that protease inhibitors are no longer a guideline for first-line regimens in the United States. And we had patients switching from the Triumeq or the components of which. And so these 2 groups are probably the groups that -- individuals that we'll see a lot of the switches from overall as we launch the product.

所以，阿萊西亞，我是安德魯。所以我認為這是多種因素共同作用的結果。當你查看支持申請文件的註冊研究時，你會發現一些患者是從基於蛋白酶的抑製劑或多片藥物方案轉而來，而且請記住，蛋白酶抑製劑在美國已不再是一線治療方案的指導原則。我們有患者從 Triumeq 或其成分轉而使用其他產品。因此，隨著產品的推出，我們可能會看到這兩類人群發生大量轉變。

And our next question comes from Ian Somaiya of BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Ian Somaiya。

Just a question on Yescarta. I'm just trying to maybe -- just would love to get your help on putting that 80% number into actual patient -- 80% of the actual patient numbers. How many patients does that represent? As we think about eligibility, are there differences in eligibility as you think about the 3 different CAR-T offerings?

關於Yescarta，我有個問題。我只是想嘗試——非常希望得到您的幫助，將 80% 這個數字轉化為實際患者人數——80% 的實際患者人數。這代表多少名患者？在考慮資格問題時，您認為三種不同的 CAR-T 療法在資格方面是否有差異？

So Ian, I mean, we think there's about 7,500 patients in the United States, so 80% of that is well over 5,000 patients. So it's a pretty good number of patients, far more than we would be able to treat this year, for example, given our manufacturing capacity. So the 80% is also really something that we're thinking about geographically. You go to a lot of the big centers and there are a lot of people who may have -- who may be eligible for Yescarta but are just in areas of the country where it's impractical or unlikely that a center would be set up, and so they would have to travel. So in fact, we think geographically, it will be a bigger coverage than that -- sorry, overall, we have bigger coverage, but just sort of geographically, if you look at it, it will cover 80% of lives. So that's why we're keeping that at that number. The second part of the question was, I forgot, was about the -- I'm sorry, Ian, I forgot the second part of your question. Hopefully, I answered it.

伊恩，我的意思是，我們認為美國大約有 7500 名患者，所以其中 80% 的患者超過 5000 人。所以患者人數相當多，遠遠超過我們今年根據我們的生產能力所能治療的人數。所以，80%這個數字也是我們從地理角度來考慮的因素。你去很多大型中心，會發現很多人可能符合 Yescarta 的資格，但他們所在的地區設立中心既不現實也不可能，所以他們必須長途跋涉。所以實際上，我們認為從地理上看，它的覆蓋範圍會更大——抱歉，總體而言，我們的覆蓋範圍更大，但就地理範圍而言，如果你看一下，它將覆蓋 80% 的人口。所以這就是我們決定將這個數字維持在這個水平的原因。問題的第二部分，我忘了，是關於──對不起，伊恩，我忘了你問題的第二部分。希望我的回答能幫助你。

And our next question comes from Jim Birchenough of Wells Fargo Securities.

下一個問題來自富國證券的吉姆·伯奇諾夫。

Just a question on the broader solid tumor opportunity for cell therapy and whether you feel like you've got the assets internally from Kite and from Cell Design Labs to have solid tumor success. What are the time lines for generating some solid tumor cell therapy data?

關於細胞療法在實體瘤治療領域更廣泛的應用前景，我想問一個問題：您是否認為公司內部擁有來自 Kite 和 Cell Design Labs 的資源，能夠在實體瘤治療方面取得成功？實體瘤細胞療法數據的產生時間表是什麼？

Jim, I don't think we have everything that we need, and as John said, one thing missing is gene editing. But we are talking to companies, and we will do more collaborative deals in that space. I would say it's early with solid tumors. Then you can -- the problem was solid tumors or the challenge, I would say, is finding a tumor-specific antigen that is not expressed on normal cells. That is, by the way, a reason why we're excited about CDL, you know, their synNotch technology. Essentially, it needs 2 antigens in order for the T-cell to get activated. So it gives you a much broader specificity if you can go after 2. So both have to be present at the same time in the same cell surface. But on the other hand, it's really it's early days, I would say, but it's exciting. That's where the real opportunity lies for cell therapy, I mean the real commercial opportunity. And you could, for instance, go after neo antigens. You could do shared antigens that we have announced one study that is ongoing with MAGE A3-A6 with the Rosenberg Group at the NCI. And so that's the opportunity. So you will see more in that space coming from Gilead in the coming years.

吉姆，我認為我們還沒有擁有所需的一切，正如約翰所說，其中缺少的一項就是基因編輯。但我們正在與一些公司洽談，我們將在該領域達成更多合作協議。我認為對於實體腫瘤來說，現在還處於早期階段。那麼你就可以——問題在於實體瘤，或者說挑戰在於找到一種在正常細胞上不表現的腫瘤特異性抗原。順便說一句，這也是我們對 CDL 及其 synNotch 技術感到興奮的原因之一。從本質上講，T 細胞需要 2 種抗原才能活化。所以，如果能針對 2 個目標分子，就能獲得更廣泛的特異性。因此，這兩個分子必須同時存在於同一個細胞表面。但另一方面，我覺得現在還處於早期階段，不過這令人興奮。這才是細胞療法的真正機會所在，我是指真正的商業機會。例如，你可以研究新抗原。您可以進行共享抗原研究，我們已經宣布了一項正在進行的與 NCI 的 Rosenberg 小組合作的 MAGE A3-A6 研究。這就是機會所在。因此，未來幾年你會看到吉利德在該領域推出更多產品。

And I would say, Jim, we're going to spread out our bets a little bit, investing in various different technologies because it's hard to predict which of these will have the breadth to be important and also the specificity and depth of response that's going to be important. So we'll be spreading our bets out there. We do think there's hopeful signs in the solid tumor area, but we've not yet -- don't have much -- it's not the similar kind of situation as it was with CD19.

吉姆，我想說，我們將分散投資，投資各種不同的技術，因為很難預測哪些技術有足夠的廣度和深度，能夠產生重要的影響。所以我們會分散投資。我們認為實體瘤領域出現了一些令人鼓舞的跡象，但我們還沒有——也沒有太多——這與 CD19 的情況並不相同。

And Ian, I remembered the question you asked about the label and how the differences between the different labels. And clearly, we don't know what the groups have asked for in terms of labeling. But currently, from what we see in the clinical studies, I don't anticipate the labels will be all that different going forward. But that could be a differentiating feature as it always is in medicine, and that could lead to better access if the labels were truly differentiated from one another. Sorry I forgot that at the time.

伊恩，我記得你問過關於標籤以及不同標籤之間區別的問題。顯然，我們並不知道這些團體在標籤上提出了什麼要求。但就目前我們在臨床研究中看到的情況來看，我預期未來的標籤不會有太大變化。但這可能就像醫學領域一樣，成為一個區別特徵，如果標籤之間真正有所區別，就能帶來更好的醫療服務取得途徑。抱歉，我當時忘了。

And our next question comes from Cory Kasimov with JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

I wanted to ask about your BCMA program. Can you talk about how you see potential differentiation here versus others in development? And will you be using the same manufacturing process as Yescarta? Or are there any new procedures being implemented as you have new CARs entering the clinic?

我想諮詢一下你們的BCMA專案。您能否談談您認為這裡與其他正在發展中的公司相比，有哪些潛在的差異化優勢？你們會採用與 Yescarta 相同的生產流程嗎？或者，隨著新的CAR患者進入診所，你們是否正在實施任何新的流程？

Cory, it's really too early to say what the differentiating features will be. We are currently doing dose escalation, and it's really a Phase I/Phase II study. And we just have to see what the results are and how they compare to the competitors' products. And yes, we're using the same construct. So it's CD-zeta and CD28 costimulatory domain with an extracellular binding domain that's different probably from the competitors. We don't know that.

科里，現在說哪些是區別性特徵還為時過早。我們目前正在進行劑量遞增試驗，這實際上是一項 I 期/II 期研究。我們只需要看看結果如何，以及它們與競爭對手的產品相比如何。是的，我們使用的是相同的結構。所以它具有 CD-zeta 和 CD28 共刺激結構域，以及一個可能與競爭對手不同的細胞外結合結構域。我們並不知道。

Yes. And in terms of the manufacturing process, it's not exactly the same as Yescarta. So we are working out unique manufacturing processes for each of these, so it will be different. We haven't determined exactly how different at the moment.

是的。就製造流程而言，它與 Yescarta 並不完全相同。因此，我們正在為每種產品製定獨特的製造工藝，所以它們都會有所不同。我們目前還沒有確定具體差異有多大。

And our final question comes from the line of Ying Huang of Bank of America.

最後一個問題來自美國銀行的黃穎。

Maybe a quick one for Norbert. I didn't see you including the filgotinib male subject safety study in your time line for 2018 to 2019 in the slide deck. And then secondly, maybe another question on the pricing dynamics in the HIV market. After you launch B/F/TAF in the U.S., do you expect your competitor, GSK, to use pricing as a potential weapon to keep its share?

或許可以給諾伯特快速解答。在幻燈片中，我沒有看到您將 filgotinib 男性受試者安全性研究納入 2018 年至 2019 年的時間線。其次，或許還可以問一個關於愛滋病毒市場定價動態的問題。在美國推出 B/F/TAF 之後，您是否認為您的競爭對手 GSK 會利用價格作為潛在的武器來保住其市場份額？

Yes, Ying, thanks for the question. That's very observant of you that you have not seen the study. Yes, we are performing a safety study. As you know, there was a safety signal in preclinical studies. And in order to justify the 200-milligram dose, which is the higher dose that we're using in the study, we were asked by FDA to perform the study. So the study is enrolling. And the reason why we don't have any time lines in it is simply we don't know yet. It's too early. So we have sites up and running. It's somewhat slow always at the start, we just simply -- it's impossible to predict what the exact time lines are.

是的，穎，謝謝你的提問。你觀察力真敏銳，居然還沒看過那項研究。是的，我們正在進行安全性研究。如您所知，臨床前研究中出現了安全訊號。為了證明我們在研究中使用的較高劑量 200 毫克的合理性，FDA 要求我們進行這項研究。研究正在招募受試者。之所以沒有給出時間表，原因很簡單，我們還不知道。現在還太早了。我們的網站已經上線運行了。開始的時候總是比較慢，我們只是──不可能預測確切的時間線。

And your second study was do we expect our competitors to lower prices. That has never happened in the field of HIV, but I don't know what ViiV and GSK are planning. That's all I can tell you.

你們的第二個研究是：我們是否預期競爭對手會降低價格？這種情況在愛滋病領域從未發生過，但我不知道ViiV和葛蘭素史克有什麼計畫。我只能告訴你這些。

And our next question comes from Hartaj Singh of Oppenheimer.

下一個問題來自奧本海默公司的哈塔吉·辛格。

I just had a quick question on PrEP with Truvada. It's becoming a fairly decent sized portion of your business, and you did indicate that Descovy is now fully enrolled. Can you just talk a little bit about the dynamics for how you see Truvada playing out? And then how do you see Descovy kind of rolling into that in the future?

我有一個關於服用 Truvada 進行暴露前預防（PrEP）的小問題。它正在成為您業務中相當可觀的一部分，而且您也表示 Descovy 現在已經完全註冊了。您能否簡單談談您認為 Truvada 的發展前景？那麼，您認為 Descovy 未來將如何融入這個產業呢？

So maybe -- it's Andrew. So I'll just start with the first thing, which is that the Descovy study is fully enrolled. It was fully enrolled in Q2 of 2017. So we expect to have results sometime in '19. But keep in mind, it's an event-driven study. So the exact time lines are slightly hard to predict this far out. It's not like our -- let's say, the bictegravir trials, which are 48-week studies. So we -- once we have our last patient, we can mark those -- block those out. Now, in terms of the dynamics of how we see Truvada and Descovy interplay, I think it's difficult to say without the results of the trial to understand the differences, although it wouldn't be unreasonable to think about looking at the dynamics in play that we've seen with HIV treatment, where safety has quite been a very important factor in driving the switch from TDF-based regimens to TAF ones.

所以，也許是安德魯。那我就先從第一點說起，那就是 Descovy 研究計畫已經全部招滿。該計畫於 2017 年第二季完成招生。因此，我們預計將在 2019 年某個時候公佈結果。但請記住，這是一項事件驅動型研究。所以，現在預測確切的時間線還為時過早。這和我們的——比如說比克替拉韋試驗——不一樣，比克替拉韋試驗是為期 48 週的研究。所以，一旦我們有了最後一個病人，我們就可以把這些病人標記出來，排除掉。至於 Truvada 和 Descovy 相互作用的動態，我認為在沒有試驗結果的情況下很難理解其中的差異，儘管可以參考 HIV 治療中觀察到的動態，因為安全性一直是推動從基於 TDF 的治療方案轉向基於 TAF 的治療方案的一個非常重要的因素。

And I just want to add one bit of data to that, which is if we look at that typical patient who's taking Truvada today, for PrEP, they take it nearly on the frequency with people who take long-term HIV therapy, so about the same number of pills taken per year. So the exposure to TDF would be significant and would carry many of the same risks as TDF was for HIV-infected patients. So TAF may be a better option, particularly given that these patients are not HIV-infected and we think that could be an opportunity as well.

我只想補充一點數據，那就是，如果我們看一下目前服用 Truvada 進行 PrEP 的典型患者，他們服用 Truvada 的頻率幾乎與接受長期 HIV 治療的人一樣，每年服用的藥片數量也大致相同。因此，接觸 TDF 的風險會很大，並且會帶來與 TDF 對 HIV 感染患者相同的許多風險。因此，TAF 可能是更好的選擇，特別是考慮到這些患者沒有感染 HIV，我們認為這可能也是一個機會。

And that concludes our question-and-answer session for today. I'd like to turn the conference back over to Sung Lee for any closing remarks.

今天的問答環節到此結束。我謹將會議交還給李成先生，請他作總結發言。

Great. Thank you, Candace, and thank you all 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.

偉大的。謝謝坎迪斯，也謝謝各位今天蒞臨現場。我們感謝您一直以來對吉利德的關注，我們的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. Everyone, have a great day.

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。