吉利德科學 (GILD) 2017 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Second Quarter 2017 Earnings Conference Call. My name is Liz, and I will be your conference operator today. (Operator Instructions)

女士們、先生們，感謝你們的耐心等待，歡迎參加吉利德科學公司2017年第二季財報電話會議。我叫莉茲，今天我將擔任你們的會議接線生。（操作說明）

And as a reminder, this conference call is being recorded.

再次提醒大家，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, Liz, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the second quarter of 2017. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

謝謝你，莉茲，大家午安。今天股市收盤後不久，我們發布了一份新聞稿，公佈了 2017 年第二季的獲利結果。新聞稿和詳細幻燈片可在吉利德公司網站的投資者關係部分查看。

The speakers on today's call will be Robin Washington, Executive Vice President and Chief Financial Officer; Kevin Young, Chief Operating Officer; Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer; and John Milligan, President and Chief Executive Officer.

今天電話會議的發言人有：執行副總裁兼財務長 Robin Washington；營運長 Kevin Young；研發執行副總裁兼首席科學官 Norbert Bischofberger；以及總裁兼執行長 John Milligan。

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. In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call.

在我們正式發言之前，請允許我提醒各位，我們將發表一些前瞻性聲明，包括有關產品、候選產品、財務預測和資本使用的計劃和預期，所有這些都涉及某些我們無法控制的假設、風險和不確定性，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。此外，吉利德不承擔更新本次電話會議中任何前瞻性聲明的義務。

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

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

I will now turn the call over to Robin.

現在我會把通話轉給羅賓。

Thank you, Sung, and good afternoon, everyone. We are pleased to provide you with an update for our second quarter. I'll review the financial results, Kevin will address the commercial performance, Norbert will highlight the progress made in R&D, and then John will make a few closing comments.

謝謝宋，大家午安。我們很高興向您提供第二季業績更新。我將回顧財務業績，凱文將介紹商業表現，諾伯特將重點介紹研發方面的進展，然後約翰將作總結發言。

Our strong performance in the second quarter was driven by a continuation of the positive trends in our non-HCV business and better-than-expected results from our HCV business, particularly in the U.S.

第二季強勁的業績得益於非丙型肝炎業務的持續正面趨勢以及丙型肝炎業務（尤其是美國業務）超出預期的業績。

Total revenues for the second quarter were $7.1 billion, with non-GAAP diluted earnings per share of $2.56. This compares to revenues of $7.8 billion and non-GAAP earnings per share of $3.08 for the same period last year.

第二季總營收為 71 億美元，非 GAAP 稀釋後每股收益為 2.56 美元。相比之下，去年同期營收為 78 億美元，非 GAAP 每股收益為 3.08 美元。

Product sales for the second quarter were $7 billion, down 8% year-over-year and up 10% sequentially. The year-over-year decline was due to lower HCV sales, partially offset by increased sales in HIV and other therapeutic areas. Sequentially, HCV sales grew 11% and HIV and other therapeutic areas sales grew 10%.

第二季產品銷售額為 70 億美元，年減 8%，季增 10%。年比下降的原因是丙型肝炎病毒（HCV）病毒的銷量下降，但愛滋病毒（HIV）和其他治療領域的銷售成長部分抵消了這一影響。丙肝藥物銷售額較上季成長 11%，愛滋病毒和其他治療領域藥物銷售額較上季成長 10%。

Turning to the U.S. Product sales for the second quarter were $5 billion, up 2% year-over-year, driven by favorable demand for our non-HCV products, offset by lower HCV sales, and up 12% sequentially, primarily due to the continued strong uptake of our TAF franchise and favorable inventory movements for HIV and HCV.

再來看美國市場。第二季產品銷售額為 50 億美元，年增 2%，主要得益於非 HCV 產品需求旺盛，但被 HCV 銷售額下降所抵消；環比增長 12%，主要歸功於 TAF 產品線的持續強勁增長以及 HIV 和 HCV 產品庫存的良好變動。

Turning to Europe. Product sales for the second quarter were $1.4 billion, down 13% year-over-year and up 11% sequentially. The year-over-year decline was primarily due to competitive dynamics in HCV and unfavorable currency movements. The sequential increase was primarily due to the onetime recognition of deferred revenue related to an HCV contract, demand for Epclusa and the continued uptake of our TAF-based regimens. Kevin will provide more color for the U.S. as well as the other regions.

轉向歐洲。第二季產品銷售額為 14 億美元，年減 13%，季增 11%。年比下降的主要原因是C肝市場的競爭動態和不利的匯率波動。環比成長主要歸因於與 HCV 合約相關的一次性遞延收入確認、對 Epclusa 的需求以及我們基於 TAF 的治療方案的持續推廣。凱文將為美國以及其他地區帶來更多色彩。

Now turning to expenses. Non-GAAP R&D expenses were $812 million for the second quarter, down 22% compared to the same period last year, due primarily to the purchase of an FDA priority review voucher in 2016.

現在來說說費用。第二季非GAAP研發費用為8.12億美元，比去年同期下降22%，主要原因是2016年購買了FDA優先審查券。

Non-GAAP SG&A expenses were $827 million for the second quarter compared to $838 million in the same period last year.

第二季非GAAP銷售、管理及行政費用為8.27億美元，去年同期為8.38億美元。

We remain focused on operating in a highly efficient manner and are proactively managing expenses and investing in areas of strategic importance to generate industry-leading operating margins, significant cash flows and a strong balance sheet.

我們將繼續專注於高效運營，積極管理支出，並投資於具有戰略意義的領域，以創造行業領先的營運利潤率、可觀的現金流和強勁的資產負債表。

We ended the quarter with $36.6 billion in cash and investments and generated cash flows from operations of $3.5 billion. While we anticipate strong cash flows in the second half of 2017, we expect a sequential decrease in the second half of the year as we anticipate large cash payments or government rebates, both in the U.S. and abroad, as well as other seasonal payments.

本季末，我們擁有現金和投資366億美元，經營活動產生的現金流為35億美元。雖然我們預計 2017 年下半年現金流強勁，但由於預計美國和海外將有大量現金支付或政府退稅，以及其他季節性付款，我們預計下半年現金流將環比下降。

As part of our plan to return capital to our shareholders, we paid cash dividends of $680 million and repurchased 2 million shares of stock for $130 million to offset dilution in the second quarter.

作為我們向股東返還資本計劃的一部分，我們支付了 6.8 億美元的現金股息，並以 1.3 億美元的價格回購了 200 萬股股票，以抵消第二季度的股權稀釋。

We continue to prioritize the use of capital for investing in the long-term growth of our business, including partnerships and acquisitions.

我們將繼續優先利用資本投資於業務的長期成長，包括合作和收購。

Finally, I would like to update our full year 2017 guidance provided to you on May 2 and summarized on Slide 6 in the earnings results presentation available on our corporate website.

最後，我想更新我們在 5 月 2 日向您提供的 2017 年全年業績指引，該指引已總結在我們公司網站上提供的盈利結果演示文稿的第 6 頁中。

We are increasing net product sales to a range of $24 billion to $25.5 billion. Non-HCV net product sales are expected to be in the range of $15.5 billion to $16 billion. HCV net product sales are expected to be in the range of $8.5 billion to $9.5 billion. This guidance reflects the strong performance we have seen in the first half of 2017 across our businesses, specifically in the U.S., while continuing to anticipate increased competitive dynamics in the U.S. and EU during the second half of the year. This guidance is subject to a number of uncertainties which are highlighted on Slide 16 in the earnings results presentation, including the accuracy of our estimates for HCV patient starts for the remainder of 2017; unanticipated pricing pressures from payers and competitors, resulting in lower-than-anticipated market share in HCV; and lower-than-expected market share and greater price erosions as the result of the introduction of generic versions of TDF and the fixed-dose combination of FTC TDF outside the U.S.

我們將淨產品銷售額提高到 240 億美元至 255 億美元之間。非丙型肝炎病毒（HCV）產品淨銷售額預計在 155 億美元至 160 億美元之間。預計HCV產品的淨銷售額將在85億美元至95億美元之間。這項預期反映了我們在 2017 年上半年各項業務，特別是美國業務的強勁表現，同時我們也持續預期今年下半年美國和歐盟的競爭格局將更加激烈。該指導意見受到許多不確定因素的影響，這些不確定因素在盈利結果演示文稿的第 16 頁中進行了重點說明，包括我們對 2017 年剩餘時間 HCV 患者開始治療的估計的準確性；來自支付方和競爭對手的意外定價壓力，導致 HCV 市場份額低於預期；以及由於 TDF 的仿製藥版本和 FTC 市場份額低於 FTC 以外的固定劑量，導緻美國市場份額低於

We are narrowing the R&D expense guidance to a range of $3.2 billion to $3.4 billion. We are also narrowing the SG&A expense guidance to a range of $3.2 billion to $3.4 billion. Finally, the diluted earnings per share impact of GAAP to non-GAAP adjustments is expected to be in the range of $0.86 to $0.93. All other components of our guidance remain unchanged.

我們將研發支出預期範圍縮小至 32 億美元至 34 億美元。我們同時將銷售、一般及行政費用預期範圍縮小至 32 億至 34 億美元。最後，GAAP 調整為非 GAAP 調整後，稀釋每股收益預計在 0.86 美元至 0.93 美元之間。我們指南的其他所有組成部分均保持不變。

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

現在我將把電話交給凱文，讓他詳細介紹我們本季的商業表現。

Thank you, Robin, and good afternoon, everyone. We continue to see strong uptake of our TAF-based regimens in the United States and Europe.

謝謝你，羅賓，大家下午好。我們持續看到基於 TAF 的治療方案在美國和歐洲受到廣泛認可。

In the U.S., total HIV and HBV revenues were $2.6 billion for the quarter, up 19% year-over-year and up 10% sequentially. These results demonstrate the strength and sustainability of our HIV franchise. At the end of June, our TAF-based regimens accounted for 51% of Gilead's total HIV prescription volume.

在美國，該季度 HIV 和 HBV 的總收入為 26 億美元，年增 19%，季增 10%。這些結果證明了我們愛滋病防治業務的實力和永續性。截至 6 月底，我們基於 TAF 的治療方案佔吉利德 HIV 處方總量的 51%。

Leading the way was Genvoya, with a treatment-naïve patient share of 41%, more than twice that of the second most prescribed therapy. This represents the highest treatment-naïve patient share for a single product or regimen since the early days of Atripla.

Genvoya 佔據主導地位，在未經治療的患者中所佔份額為 41%，是處方量第二大的療法的兩倍多。這是自 Atripla 成立初期以來，單一產品或治療方案中未接受過治療的患者比例最高的一次。

In addition, more than 1/3 of patients who switched HIV therapy now switched to Genvoya.

此外，超過三分之一的 HIV 治療患者現在改用 Genvoya。

More broadly, Gilead's single-tablet regimens represented 4 of the top 5 most prescribed products across all categories: treatment-naïve, switch and total treated patients.

更廣泛地說，吉利德的單片療法在所有類別（初治患者、轉換治療患者和所有接受治療的患者）中，佔據了處方量排名前五的產品中的四席。

Beyond TAF, Truvada for PrEP continues to be an important option when used as part of a comprehensive strategy to prevent HIV transmission.

除了 TAF 之外，Truvada 在 PrEP 中仍然是預防 HIV 傳播的綜合策略中的一個重要選擇。

We estimate that approximately 136,000 people in the U.S. were using Truvada for PrEP as we exited the second quarter. We are also encouraged to see third-party providers announcing new initiatives on broadening access to PrEP.

我們估計，截至第二季末，美國約有 136,000 人使用 Truvada 進行 PrEP。我們也很高興看到第三方供應商宣布了擴大 PrEP 服務範圍的新措施。

Turning to Europe. Total HIV and HBV revenues were $732 million in the second quarter, down 3% year-over-year and up 5% sequentially. The year-over-year decrease was driven by negative foreign exchange. The sequential increase was due to robust demand for our HIV therapists.

轉向歐洲。第二季 HIV 和 HBV 總營收為 7.32 億美元，年減 3%，較上季成長 5%。年比下降是由於外匯匯率波動造成的。人員數量的持續成長是由於市場對我們愛滋病治療師的強勁需求。

Strong uptake of our TAF franchise continues throughout Europe. Based on preliminary data for the second quarter, Genvoya is expected to be the most prescribed therapy for both treatment-naïve and switch patients across the top 5 European markets collectively.

我們的TAF特許經營權在歐洲持續受到熱烈歡迎。根據第二季的初步數據，Genvoya 預計將成為歐洲前五大市場中，無論是初治患者或轉診患者，處方量最大的治療藥物。

I'm delighted to say that in France, the largest HIV market in Europe, Genvoya became the most prescribed HIV regimen for treatment-naïve and switch patients just 4 months after launch.

我很高興地宣布，在歐洲最大的 HIV 市場——法國，Genvoya 在上市僅 4 個月後就成為初治患者和轉診患者最常用的 HIV 治療方案。

Turning to Descovy and Odefsey. We now have these products available in 19 and 16 European countries, respectively. Additional launches are anticipated in 2017 as pricing and reimbursement discussions continue.

轉向 Descovy 和 Odefsey。目前，這些產品分別在歐洲19個國家和16個國家有販售。隨著定價和報銷談判的繼續，預計 2017 年將有更多產品上市。

Guidelines have a significant impact on prescribing patents. Following the recent inclusion in France, Genvoya is now preferred -- is now a preferred regimen in country guidelines in all 5 of the major European markets.

指引對處方患者有重大影響。繼最近被法國納入治療方案後，Genvoya 現在是所有 5 個主要歐洲市場國家指南中的首選治療方案。

Turning to HCV. Total revenues in the U.S. were $1.9 billion in the second quarter, down 17% year-over-year and up 13% sequentially. The quarter-on-quarter increase was primarily due to a change in inventory and the timing of patient starts. Our market share for the quarter remained high at approximately 80%.

轉向丙型肝炎。第二季美國總營收為 19 億美元，年減 17%，季增 13%。季度環比增長主要是由於庫存變化和患者開始治療的時間安排所致。本季我們的市佔率維持在較高水平，約 80%。

HCV patient starts in the first 6 months were better than we originally anticipated. As a result, while we still expect a gradual decline over the second half of the year, we estimate total U.S. market starts to be 185,000 to 200,000 for 2017.

丙型肝炎患者在最初 6 個月的治療效果比我們最初預期的還要好。因此，儘管我們仍然預計下半年將逐漸下降，但我們估計 2017 年美國市場總開機量將達到 185,000 至 200,000 台。

Approximately 9 million individuals were tested for HCV in 2016, a 15% increase from 2015. As you may recall, we launched an educational campaign in October of last year to encourage baby boomers to get tested. Our research shows that there has been an 80% increase in HCV antibody screening by baby boomers since the start of this initiative.

2016 年約有 900 萬人接受了C型肝炎病毒檢測，比 2015 年增加了 15%。您可能還記得，我們​​在去年十月發起了一項教育宣傳活動，鼓勵嬰兒潮世代接受檢測。我們的研究表明，自該計劃啟動以來，嬰兒潮世代接受丙型肝炎病毒抗體篩檢的人數增加了 80%。

As testing has increased, so has diagnosis. Approximately 190,000 people were newly diagnosed with HCV in 2016, a 32% increase from 2015. This reinforces our belief that there is a significant opportunity to treat and cure many HCV-infected individuals for years to come. Gilead is committed to raising disease awareness and urging all individuals at risk for or living with HCV, to talk to their healthcare provider.

隨著檢測量的增加，診斷率也隨之提高。2016 年約有 19 萬人被新診斷出患有C型肝炎，比 2015 年增加了 32%。這更加堅定了我們的信念，在未來幾年內，我們有很大的機會治療和治癒許多丙型肝炎病毒感染者。吉利德致力於提高人們對丙型肝炎的認識，並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交談。

Turning to Europe. Total HCV revenue in the second quarter was $591 million, down 24% year-over-year and up 21% from the previous quarter. As Robin mentioned, the quarter-on-quarter increase was due to the onetime recognition of a deferred revenue related to an HCV contract.

轉向歐洲。第二季HCV總營收為5.91億美元，年減24%，季增21%。正如 Robin 所提到的，季度環比增長是由於一次性確認了與 HCV 合約相關的遞延收入。

Gilead patient starts were approximately 23,000 for the quarter, as declining trends in early launch countries were offset by the opening of access in other markets. With the addition of France, Italy and Spain earlier this year, all 5 major European markets have now agreed to expand access to patients regardless of fibrosis score. This means that there are now 16 European countries that allow patient access regardless of disease severity.

吉利德本季新增患者約 23,000 例，早期上市國家的下滑趨勢被其他市場准入的開放所抵銷。今年早些時候，法國、義大利和西班牙也加入了這一行列，至此，歐洲五大市場均已同意擴大患者就醫範圍，無論其纖維化評分如何。這意味著目前已有 16 個歐洲國家允許病患無論病情輕重都能獲得醫療服務。

We are seeing rapid uptake of Epclusa, mirroring the same success we had some 9 months ago in the U.S. Epclusa is quickly becoming the standard of care for HCV patients with genotypes 2 and 3, and reimbursement has been achieved in 21 countries.

我們看到 Epclusa 的推廣迅速，與我們大約 9 個月前在美國的成功如出一轍。 Epclusa 正迅速成為 2 型和 3 型 HCV 患者的標準治療方案，並且已在 21 個國家/地區獲得醫療保險報銷。

While many people have been diagnosed with HCV and cured, there remain millions of people infected with HCV throughout Europe. In Germany, there are over 100,000 people estimated to be infected with HCV, who are unaware that they have the disease. In partnership with the German Liver Foundation, Gilead has launched its first large multichannel disease awareness campaign to communicate that HCV can affect anyone and encourage all individuals at risk to talk to their healthcare provider.

雖然許多人已被診斷出患有丙型肝炎並已治愈，但整個歐洲仍有數百萬人感染丙型肝炎病毒。據估計，德國有超過 10 萬人感染了C型肝炎病毒，但他們並不知道自己患有這種疾病。吉利德與德國肝臟基金會合作，發起了首個大型多通路疾病意識宣傳活動，旨在傳達丙型肝炎病毒可影響任何人的信息，並鼓勵所有有風險的人與他們的醫療保健提供者交談。

Looking to the second half of 2017, and with the launch of Vosevi, we believe that Gilead has the most comprehensive portfolio of products to meet the needs of almost all hepatitis C patients regardless of disease severity, regardless of genotype and regardless of prior treatment.

展望 2017 年下半年，隨著 Vosevi 的上市，我們相信吉利德擁有最全面的產品組合，能夠滿足幾乎所有丙型肝炎患者的需求，無論疾病嚴重程度、基因型和先前治療情況如何。

Finally, as I highlighted last quarter, our U.S. cardiopulmonary team is delivering consistently impressive results. They embody the same tenants of operational excellence as our HIV and liver teams.

最後，正如我在上個季度所強調的那樣，我們的美國心肺團隊一直在取得令人印象深刻的成果。他們體現了與我們的愛滋病和肝病團隊相同的卓越營運原則。

Letairis and Ranexa revenue totaled $430 million for the quarter.

Letairis 和 Ranexa 本季總營收為 4.3 億美元。

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

現在我想把電話交給諾伯特。

Thank you, Kevin. Earlier this week, we announced the exciting results presented at the IAS meeting in Paris from 2 Phase III studies, studies 1489 and 1490, evaluating a fixed-dose combination of B/F/TAF compared to the triple therapy regimens containing dolutegravir among treatment-naïve patients. In study 1489, adults with HIV were randomized to receive B/F/TAF or the fixed-dose combination of abacavir dolutegravir lamivudine. And in study 1490, adults with HIV were randomized to receive B/F/TAF for dolutegravir plus F/TAF. In both studies, B/F/TAF met its primary objective on noninferiority as defined by the proportion of patients who achieved virological suppression. There was no treatment emerging resistance through 48 weeks, b/F/TAF was well tolerated and no patients discontinued study mitigation due to renal events in either study.

謝謝你，凱文。本週早些時候，我們宣布了在巴黎舉行的 IAS 會議上公佈的兩項 III 期研究（研究 1489 和 1490）的激動人心的結果，這兩項研究評估了 B/F/TAF 固定劑量組合與含有多替拉韋的三聯療法方案在初治患者中的療效。在 1489 號研究中，HIV 成年患者被隨機分配接受 B/F/TAF 或阿巴卡韋、多替拉韋和拉米夫定的固定劑量組合。在 1490 號研究中，HIV 成年患者被隨機分配接受 B/F/TAF 治療，即多替拉韋加 F/TAF 治療。在兩項研究中，B/F/TAF 均達到了其主要目標，即非劣效性，定義為達到病毒學抑制的患者比例。在 48 週內未出現治療抗藥性，b/F/TAF 耐受性良好，兩項研究中均無患者因腎臟事件而中止研究。

Additionally, no new safety signals were observed, and the nature and incidence of adverse events in laboratory abnormalities were similar among treatment groups, with the exception of nausea in study 1489 which occurred with higher frequency in the abacavir dolutegravir lamivudine arm.

此外，未觀察到新的安全訊號，各治療組的實驗室異常不良事件的性質和發生率相似，但 1489 研究中阿巴卡韋、多替拉韋和拉米夫定組的噁心發生率較高。

It was also reported at the conference that in study 1489, there were more patient self-reported neurological and constitutional adverse events in the abacavir dolutegravir lamivudine arm. These results reinforce the value of pairing bictegravir, an unboosted integrase inhibitor with a high barrier to resistance, with the demonstrated long-term safety profile of the F/TAF backbone, addressing the limitations of current HIV therapy. B/F/TAF could represent an important advance in the triple therapy treatment for a broad range of HIV patients, including the aging population and those with mild-to-moderate renal impairment.

會議還報告稱，在 1489 項研究中，阿巴卡韋、多替拉韋和拉米夫定組的患者自我報告的神經系統和全身不良事件更多。這些結果強化了將比克替拉韋（一種具有高抗藥性屏障的非增強型整合酶抑制劑）與已證實具有長期安全性的 F/TAF 骨架相結合的價值，從而解決了當前 HIV 療法的局限性。B/F/TAF 可能代表三聯療法治療中的一個重要進步，適用於包括老年人群和輕度至中度腎功能損害患者在內的廣泛的 HIV 患者。

Last month, Gilead filed a new drug application for B/F/TAF with the U.S. Food and Drug Administration based on data from studies 1489 and 1490 and 2 other ongoing studies evaluating the single-tablet regimen in virologically suppressed patients. In both these studies, patients were randomized to either switch to B/F/TAF or remain on their existing regimen, which in one study is a triple-therapy regimen containing abacavir dolutegravir lamivudine and the other study, a regimen of 2 nucleoside or nucleotide reverse transcriptase inhibitors and a booster protease inhibitor. We plan to present data from these studies at scientific meetings later this year.

上個月，吉利德公司根據 1489 和 1490 研究的數據以及另外 2 項正在進行的研究的數據，向美國食品藥物管理局提交了 B/F/TAF 的新藥申請，這些研究評估了病毒學抑制患者使用單片療法的效果。在這兩項研究中，患者被隨機分配到兩組：一組改用 B/F/TAF 方案，另一組繼續使用現有方案。其中一項研究採用的是包含阿巴卡韋、多替拉韋和拉米夫定的三聯療法；另一項研究採用的是包含 2 種核苷或核苷酸類逆轉錄酶抑制劑和 1 種蛋白酶抑制劑的方案。我們計劃在今年稍後的科學會議上公佈這些研究的數據。

In addition to these 4 studies, we have 1 other study ongoing, where patients on dolutegravir and Descovy are randomized to stay on that regimen or switch to B/F/TAF.

除了這 4 項研究之外，我們還有 1 項正在進行的研究，其中接受 dolutegravir 和 Descovy 治療的患者被隨機分配繼續接受該治療方案或轉而接受 B/F/TAF 治療。

In the European Union, Gilead's Marketing Authorization Application for B/F/TAF was fully validated earlier this month and is now under evaluation by the European Medicines Agency.

在歐盟，吉利德公司針對B/F/TAF的上市許可申請已於本月初獲得全面驗證，目前正在接受歐洲藥品管理局的評估。

With regards to HIV prevention research, we're pleased to report that the Discover trial is now fully enrolled ahead of schedule, with more than 5,000 participants across North America and Europe. The Discover study randomized patients to receive Truvada or Descovy to evaluate whether Descovy is safe and effective at reducing the risk of HIV infection when used as a pre-exposure prophylaxis.

關於 HIV 預防研究，我們很高興地報告，Discover 試驗已提前完成全部招募工作，在北美和歐洲共有 5000 多名參與者。Discover 研究將患者隨機分為兩組，分別接受 Truvada 或 Descovy 治療，以評估 Descovy 作為暴露前預防藥物時，在降低 HIV 感染風險方面是否安全有效。

Turning to our NASH. Two Phase III trials, STELLAR 3 and STELLAR 4, are underway, evaluating selonsertib which is our ASK1 inhibitor in patients with F3 bridging fibrosis and F4 cirrhosis. Enrollment in these studies is going well. And since initiating the studies in March of this year, we have already screened more than 1,000 patients. We're confident that these studies will be fully enrolled in the first half of 2018.

轉向我們的 NASH。兩項 III 期試驗 STELLAR 3 和 STELLAR 4 正在進行中，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。這些研究的招募工作進展順利。自今年 3 月啟動研究以來，我們已經篩選了 1000 多名患者。我們有信心這些研究將在 2018 年上半年完成全部受試者招募。

Recall that in a Phase II study, selonsertib was shown to reverse fibrosis and decrease fibrosis progression in a dose-dependent manner.

回想一下，在 II 期研究中，selonsertib 已被證明可以逆轉纖維化並降低纖維化進展，且呈現劑量依賴性。

Additionally, 2 other compounds with different mechanisms of action, an ACC inhibitor, GS-0976; and an FXR agonist, GS-9674, are currently in Phase II, with data readouts anticipated in the second half of this year. We're also exploring combinations of the 3 agents in Phase IIa studies.

此外，另外兩種作用機制不同的化合物，即 ACC 抑制劑 GS-0976 和 FXR 激動劑 GS-9674，目前正處於 II 期臨床試驗階段，預計今年下半年公佈數據。我們也在 IIa 期研究中探索這 3 種藥物的組合。

In oncology, a Phase III study of Andecaliximab which is our anti-MMP9 antibody in patients with gastric cancer is ongoing. And interim futility analysis from this study will be conducted later this year.

在腫瘤學領域，我們正在對安地卡利昔單抗（一種抗 MMP9 抗體）治療胃癌患者進行 III 期研究。今年稍後將對這項研究進行中期無效性分析。

In addition, a Phase IIa study has been initiated to evaluate combinations of our BTK inhibitor, Tirabrutinib with our PI3K inhibitor, idelalisib; and our Syk inhibitor, entospletinib in combination with Obinutuzimab in patients with relapsed/refractory CLL. We're also evaluating entospletinib in a Phase II study in acute myeloid leukemia.

此外，我們已啟動一項 IIa 期研究，以評估我們的 BTK 抑制劑 Tirabrutinib 與我們的 PI3K 抑制劑 idelalisib 聯合用藥，以及我們的 Syk 抑制劑 entospletinib 與 Obinutuzimab 聯合用藥治療復發/難治性 CLL 患者的療效。我們也評估急性骨髓性白血病的 II 期研究中 entospletinib 的療效。

In inflammation, 5 Phase III studies of filgotinib are ongoing in patients with rheumatoid arthritis, ulcerative colitis and Crohn's disease. We plan to initiate a Phase II study with filgotinib in combination with GS-9876, a Syk inhibitor.

在發炎方面，filgotinib 正在進行 5 項 III 期研究，受試者包括類風濕性關節炎、潰瘍性結腸炎和克隆氏症患者。我們計劃啟動一項 II 期研究，將 filgotinib 與 Syk 抑制劑 GS-9876 合併使用。

In summary, significant progress has been made with many of our programs. Four molecules are continuing in Phase III, including Descovy for PrEP, selonsertib for NASH, filgotinib for rheumatoid arthritis, ulcerative colitis and Crohn's disease, and we expect to see a number of regulatory and clinical milestones in the second half of this year.

總而言之，我們的許多專案都取得了顯著進展。目前有四款分子藥物正處於 III 期臨床試驗階段，包括 PrEP 的 Descovy、用於 NASH 的 selonsertib、用於類風濕性關節炎、潰瘍性結腸炎和克羅恩病的 filgotinib，我們預計今年下半年將取得一系列監管和臨床里程碑。

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

現在我想把電話交給約翰。

Thanks, Norbert. I'm going to keep my remarks brief so we can get to your questions.

謝謝你，諾伯特。我盡量長話短說，以便盡快回答你們的問題。

I do want to emphasize the importance of Norbert's comments a few moments ago. We made tremendous strides with antiretroviral therapy over the past 2 decades. But still today, every treatment option available has some compromise, be that a food requirement, the risk of side effects, tolerability, the emergence of viral resistance or a potential interaction with another medication. Those trade-offs and comprises that people living with HIV and their healthcare providers have to make may be minimized to perhaps the greatest extent possible with B/F/TAF. This is why we are so encouraged by the data presented at the IAS conference in Paris this week and by the data in patients switching from other HIV medication that will be presented at scientific meetings later this year.

我想強調一下諾伯特剛才的評論的重要性。過去二十年來，我們在抗病毒療法方面取得了巨大的進步。但時至今日，每一種治療方案都存在一些妥協之處，例如對食物的要求、副作用的風險、耐受性、病毒抗藥性的出現或與其他藥物的潛在交互作用。透過 B/F/TAF，或許可以最大限度地減少 HIV 感染者及其醫療保健提供者必須做出的權衡和妥協。這就是為什麼我們對本週在巴黎舉行的國際愛滋病協會會議上公佈的數據，以及今年稍後將在科學會議上公佈的從其他 HIV 藥物轉換而來的患者的數據感到非常鼓舞。

I'd also like to take this time to congratulate our partner, Janssen for the positive CHMP opinion on SYMTUZA, a single-tablet regimen containing darunavir, cobicistat, emtricitabine and tenofovir alafenamide or TAF. When approved by the European Commission, SYMTUZA will be the first commercially-available STR containing a protease inhibitor, an important option for patients who previously had to consume 2 or more tablets every day.

我還要藉此機會祝賀我們的合作夥伴 Janssen 公司獲得了 CHMP 對 SYMTUZA 的積極意見，SYMTUZA 是一種含有達蘆那韋、考比司他、恩曲他濱和替諾福韋艾拉酚胺（TAF）的單片療法。SYMTUZA 獲得歐盟委員會批准後，將成為首個市售的含有蛋白酶抑制劑的單片複方製劑，對於以前每天必須服用 2 片或更多片劑的患者來說，這是一個重要的選擇。

Turning to HCV. Last month, the CHMP issued a positive opinion on Gilead's application for marketing authorization for Vosevi. Then, just last week, the U.S. FDA approved Vosevi for the treatment of HCV genotypes 1 through 6 in patients who virus rebounded during or after treatment with an NS5A inhibitor and in patients with genotypes 1A and 3 who have been previously treated with a sofosbuvir-containing regimen. The approval is 3 weeks ahead of PDUFA date and marked Gilead's fourth HCV therapy approval in 3.5 years.

轉向丙型肝炎。上個月，人用藥品委員會 (CHMP) 對吉利德公司 Vosevi 的上市許可申請發表了積極意見。就在上週，美國 FDA 批准 Vosevi 用於治療在 NS5A 抑制劑治療期間或之後病毒反彈的 HCV 基因型 1 至 6 患者，以及先前接受過含索非布韋方案治療的基因型 1A 和 3 患者。該批准比 PDUFA 日期提前了 3 週，標誌著吉利德在 3.5 年內第四次批准了 HCV 療法。

We commenced our launch plan immediately upon notification by FDA. Bottles of Vosevi were shipped to wholesalers last week and is now available on pharmacies.

收到FDA通知後，我們立即啟動了產品上市計畫。Vosevi 已於上週發往批發商，現在藥局有販售。

We are aware that prescriptions were written within hours of the approval and are pleased that many patients who have run out of options and are worried about the progression of their liver disease will now have another chance to be cured of their HCV infection.

我們了解到，處方在批准後的幾個小時內就被開出了，我們很高興許多已經走投無路、擔心肝病惡化的患者現在將有機會再次治愈他們的丙型肝炎病毒感染。

We had a strong second quarter and as you heard from Norbert, our pipeline is growing and maturing in HIV, NASH, inflammatory diseases and oncology. We are looking ahead to a number of exciting clinical milestones in the second half of this year and the continued progression of the B/F/TAF regulatory review in the U.S., Europe and other countries.

我們第二季業績強勁，正如你從諾伯特那裡聽到的，我們在 HIV、NASH、發炎性疾病和腫瘤領域的研發管線正在不斷增長和成熟。我們期待今年下半年取得一系列令人興奮的臨床里程碑，並期待B/F/TAF在美國、歐洲和其他國家繼續推動監管審查。

I want to take this opportunity to thank Gilead's 9,000 employees for the incredible focus, hard work and execution over the first half of this year. In the interest of time, let's now open the call for questions. Operator?

我想藉此機會感謝吉利德公司的9,000名員工，感謝他們在今年上半年展現的專注、努力和執行力。為了節省時間，我們現在開始接受提問。操作員？

(Operator Instructions)

（操作說明）

Our first question comes from the line of Geoff Meacham with Barclays.

我們的第一個問題來自巴克萊銀行的傑夫·米查姆。

Got one for Kevin or Norbert. So the Genvoya launch continues to look really, really good. I wanted to know, now that you have the bictegravir data in hand, one, how are you thinking about positioning relative to Genvoya? And two, is there enough differentiation versus dolutegravir to take share that you didn't get with Genvoya?

給凱文或諾伯特準備了一份。所以 Genvoya 的發布看起來真的非常非常成功。我想知道，既然您已經掌握了比克替拉韋的數據，那麼，您是如何考慮它相對於 Genvoya 的定位的？第二，與多替拉韋相比，Genvoya 是否有足夠的差異化優勢，能夠獲得 Genvoya 未能獲得的市場份額？

Geoff, thank you for the question. I should say straight away that not in the room today is Jim Myers, our Executive Vice President for Commercial Operations, because actually, Jim's been Paris these last few days. He's heading back today and he certainly relayed to us the excitement around BIC/F/TAF. We've had several key opinion leader advisory boards and I think the data that we've presented them from the first 2 studies have been exceedingly well-received. Having said that, Geoff, we've made a flying start with Genvoya. I don't think we could be happier. As I said in my script, over half of our patients are now TAF-based in the U.S. and we have a range of different conversions in Europe, but somewhere like Germany, it was our first country, is now upwards of 65%. So we're thrilled with the adoption of Genvoya, not only that, Descovy and Odefsey. And as I think I said in the past, the success of BIC/F/TAF is on the platform of the adoption of Descovy-based regimens. So we consider this a total family. We're still really excited about BIC/F/TAF. Nothing has changed, the data is reinforced, so we got a tremendous product. It's a beautiful, small pill, and we think it can be very strongly additive to our F/TAF portfolio of drugs. So as far as we're concerned, we're now going to be moving to very high gear for the launch of that new regimen come 2018.

傑夫，謝謝你的提問。我必須立即說明，今天我們的商業營運執行副總裁吉姆·邁爾斯不在場，因為吉姆這幾天一直在巴黎。他今天就要回去了，而且他確實向我們傳達了他對 BIC/F/TAF 的興奮之情。我們已經成立了幾個關鍵意見領袖顧問委員會，我認為我們向他們展示的前兩項研究的數據受到了非常好的評價。話雖如此，Geoff，我們與 Genvoya 的合作已經取得了巨大的成功。我想我們再幸福不過了。正如我在劇本中所說，在美國，我們超過一半的患者現在都以 TAF 為基礎，在歐洲，我們有各種不同的轉換，但在像德國這樣的地方，它是我們的第一個國家，現在這一比例高達 65%。所以，我們對 Genvoya 的採用感到非常興奮，不僅如此，Descovy 和 Odefsey 也得到了採用。正如我之前所說，BIC/F/TAF 的成功在於採用基於 Descovy 的治療方案。所以我們認為這是一個完整的家庭。我們仍然對 BIC/F/TAF 感到非常興奮。一切都沒有改變，數據得到了證實，所以我們得到了非常棒的產品。它是一種漂亮的小藥丸，我們認為它可以非常有效地補充我們的 F/TAF 藥物組合。所以就我們而言，我們現在將全力以赴，爭取在 2018 年推出這項新計劃。

Yes, Geoff, you asked about differentiation from dolutegravir. If you look at the results from study 1490, the 2 -- so comparing dolutegravir F/TAF to B/F/TAF, the 2 drugs are virologically identical, adverse events laboratory abnormalities are the same. The real differentiation is we have one single pill, co-formulated, one co-pay, one pill, that's the big differentiation from dolutegravir.

是的，Geoff，你問的是它與多替拉韋的區別。如果你查看 1490 研究的結果，你會發現 2——比較多替拉韋 F/TAF 和 B/F/TAF，這兩種藥物在病毒學上是相同的，不良事件實驗室異常也相同。真正的區別在於我們只有一粒藥丸，是聯合配方，只需支付一次共付額，一粒藥丸，這就是與多替拉韋的最大區別。

Our next question comes from Matthew Harrison with Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

I guess, if I could ask, you called out -- I guess, the broad question here is around what you're seeing in the HCV market and sort of sustainability of the revenues that you've talked about. And related to that, could you just comment -- I think you called out a couple one-time items but you didn't disclose the size of the inventory or the size of the 1x payments. If you'd be willing to just -- if you're not willing to disclose that number, could you just give us an idea of the relative size of those? That would be helpful.

我想，如果可以的話，我想問一下，您剛才提到——我想，這裡的主要問題是，您在丙型肝炎市場看到了什麼，以及您談到的收入的可持續性。關於這一點，您能否評論一下——我認為您提到了一些一次性項目，但您沒有透露庫存規模或一次性付款的規模。如果您不願意透露具體數字，能否讓我們大致了解一下這些數字的相對大小？那會很有幫助。

Hey, Matthew, it's Kevin. I'll kick off and then Robin can add to my comments. We're very pleased that there is this increased number of patients that have started in the first half of the year. I think naturally, we were careful and sensitive in going into 2017. The cure market has surprises on the way up and it's certainly surprises on the way down. So I think we took a very careful approach to what might happen in 2017. It is clear that more patients are starting than we had predicted in our guidance. And as I said in my opening remarks, we now think it's going to be in the range of 185,000 to 200,000 patients. So clearly, that's very positive. The other thing I would say is my comments on identifying HCV-infected individuals. If you think about it, as we're treating and curing patients, we want to make sure that the patients infected are coming into the system, albeit that they generally seem to be less ill than they were a few years ago. But it's important to still keep the movement of patients coming through. And as I said, we still consider this a large market, a very important market for Gilead, albeit that we still think there is a gradual trend down. And where that sort of turns the corner or bottoms out right now still remains to be seen.

嘿，馬修，我是凱文。我先開場，然後羅賓可以補充我的觀點。我們非常高興看到今年上半年開始接受治療的患者人數增加。我認為，進入 2017 年，我們自然而然地變得謹慎而敏感。治療藥物市場上漲時會有意想不到的情況發生，下跌時也是如此。所以我認為我們對2017年可能發生的事情採取了非常謹慎的態度。很明顯，實際開始治療的患者人數比我們在指南中預測的要多。正如我在開場白中所說，我們現在認為患者人數將在 185,000 至 200,000 人之間。所以很明顯，這是個非常正面的訊號。我還要補充一點，關於如何辨識C型肝炎病毒感染者。仔細想想，當我們在治療和治癒病人時，我們希望確保感染者能夠進入醫療系統，儘管他們通常看起來比幾年前病情要輕一些。但維持病患就診流程的暢通仍然非常重要。正如我所說，我們仍然認為這是一個很大的市場，對吉利德來說是一個非常重要的市場，儘管我們仍然認為它有逐漸下降的趨勢。而這種情況何時會轉好或觸底反彈，目前還不得而知。

Hi, Matt. And to answer the third part of your question, the specific items that we called out. So on HCV in the U.S., we did talk about inventory. And I would say that trend is not any different than what we've typically seen in HIV. I think we've not called them out in the past because we've typically had other changes that somewhat masked them. But with a sequential change or with a sequential kind of stabilization of pricing as well as patient starts and market share, that shift in inventory is just more noticeable. But the same IMA agreements are in place for HIV exists, the ranges for overall inventory were maintained quarter-on-quarter. And keep in mind, with the Epclusa launch last fall, just that ongoing kind of volatility to get to steady-state is what we see the dynamics impacting us where we had kind of an inventory build here, given inventory adjustments the last couple of quarters. I just want to emphasize that despite the inventory change, that the real underlying driver is just what Kevin talked about in the U.S. It's really increased patient starts. And so the inventory change was just one component of the overperformance. In EU, the other area we called out was the onetime deferred revenue recognition from a volume-based contract agreement that we had in Italy that expired. So we have been recognizing revenue a little conservative to date and so, we had a catch-up onetime adjustment. If you take that out, the HCV revenue for Europe sequentially would have been about flat.

嗨，馬特。至於你問題的第三部分，就是我們提到的那些具體項目。所以，關於美國的C型肝炎，我們確實談到了庫存問題。我認為這種趨勢與我們通常在愛滋病毒感染中看到的趨勢並無不同。我認為我們過去沒有公開指出這些問題，是因為我們通常會進行其他一些調整，這些調整在某種程度上掩蓋了這些問題。但是，隨著價格、患者數量和市場份額的逐步變化或逐步穩定，庫存的這種變化就更加明顯了。但針對愛滋病毒的IMA協議同樣有效，整體庫存範圍按季度保持不變。請記住，隨著 Epclusa 去年秋季的推出，正是這種持續的波動才能達到穩定狀態，我們看到這種動態影響著我們，鑑於過去幾個季度的庫存調整，我們這裡出現了庫存積壓。我只想強調，儘管庫存發生了變化，但真正的根本驅動因素正如凱文在美國談到的那樣，那就是患者數量確實增加了。因此，庫存變化只是業績超預期的一個組成部分。在歐盟，我們提到的另一個領域是我們在義大利簽訂的基於銷售的合約協議到期後產生的一次性遞延收入確認。因此，我們迄今為止在確認收入方面一直比較保守，所以，我們進行了一次性的追趕性調整。如果剔除這部分，歐洲HCV的營收季減將基本持平。

Our next question comes from Geoff Porges of Leerink Partners.

我們的下一個問題來自 Leerink Partners 的 Geoff Porges。

Two very quick questions. I apologize, but could you -- Robin, could you let us know when we should anticipate the first generic Truvada in the U.S., given your agreement with Teva? At least, can we anticipate that it won't be in the next 18 months? And secondly, Norbert, I'm sure you've looked very hard at the filgotinib clinical experience to date. And could you comment on whether you've seen any thromboembolic events, any imbalance in such events or whether you believe in any way it's related to JAK kinase inhibition?

兩個簡短的問題。很抱歉，羅賓，鑑於你與梯瓦製藥的協議，你能否告知我們何時可以期待美國第一款仿製 Truvada 上市？至少，我們可以預期它不會在未來 18 個月內發生嗎？其次，諾伯特，我相信你已經非常仔細地研究了迄今為止 filgotinib 的臨床經驗。您能否就您是否觀察到任何血栓栓塞事件、此類事件的任何失衡情況，或者您是否認為這與 JAK 激酶抑制有任何關係發表評論？

So specifically in the first question, Geoff, it's John Milligan, with regard to generic Truvada. We don't expect generic Truvada in the United States until 2021.

所以具體來說，在第一個問題中，Geoff，是 John Milligan，關於通用名 Truvada 的問題。我們預計美國要到 2021 年才會出現 Truvada 的仿製藥。

Geoff, we have looked, of course, at our database since the news was announced by Lilly and Insight. And we have found a total of 3 thromboembolic events. This is, by the way, in a database of 1,900 patients, years of experience. One of the events was by the investigator said it's not related to the study drug because it was recurrent, this was pulmonary embolism. One of them was unlikely and one of them was possible. So it's really a small number and as you also know, thromboembolic events in inflammatory conditions, in general, are not unusual. But I would like to point out, we are, in our filgotinib study, I think we have derisked the program by pursuing 2 doses. This is something that the FDA asked us to do, we agreed. And so if there should be a difference between the 2 doses, we will see it. Geoff, I would like to add another, this is more speculation and hypothesis. If you believe that these events that Lilly saw are drug-related, so that's, of course, a big question because this is a total of 5. Yes, the second is if you then believe that they have to do with high platelet numbers, then they all kind of make sense because baricitinib makes platelets go up. Filgotinib, in contrast, as it shows a platelet decrease. So if this is real and if this is the mechanism, then we should not be seeing this. Again, this is somewhat speculative and hypothesis.

Geoff，當然，自從禮來和Insight宣布這一消息以來，我們已經查看了我們的資料庫。我們共發現了 3 例血栓栓塞事件。順便一提，這是在一個擁有 1900 名患者、多年經驗的資料庫中得出的結論。調查人員表示，其中一起事件與研究藥物無關，因為它反覆發生，這是肺栓塞。其中一件不太可能，一件則有可能。所以這個數字真的很小，而且你也知道，在發炎情況下發生血栓栓塞事件通常並不罕見。但我想指出的是，在我們的 filgotinib 研究中，我認為我們採用 2 個劑量降低了該專案的風險。這是美國食品藥物管理局（FDA）要求我們做的，我們也同意了。因此，如果兩種劑量之間存在差異，我們就會發現。傑夫，我還想補充一點，這更多是推測和假設。如果你認為禮來觀察到的這些事件與藥物有關，那麼這當然是一個大問題，因為總共有 5 起。是的，第二個問題是，如果你認為它們與血小板計數升高有關，那麼這一切就都說得通了，因為巴瑞替尼會使血小板升高。相比之下，菲戈替尼則會導致血小板減少。所以如果這是真的，如果這就是機制，那我們就不應該看到這種情況。再次聲明，這只是推測和假設。

Our next question comes from Alethia Young with Credit Suisse.

下一個問題來自瑞士信貸的 Alethia Young。

I guess, Kevin, I just want to dig a little bit more into kind of the trends we're seeing in Europe. I saw that kind of Genvoya rose up to the top position in naïve. And I guess, I just want to know a little bit more under the hood of what's driving the dynamics there in Europe for HIV.

凱文，我想更深入地探討我們在歐洲看到的一些趨勢。我看到那種 Genvoya 在天真無邪的環境中崛起，並最終佔據了領先地位。我想，我只是想更深入地了解歐洲愛滋病毒傳播動態背後的驅動因素。

Alethia, thank you for the comments. Yes, we're delighted with the quarter. I think it was just all around solid across regions. All our products are -- I also salute Norbert for some incredible milestones on the R&D front. So we're really pleased with where we are as a company in the middle of the year. Yes, Genvoya is now starting to exhibit across the country, the same performance that we are having in the U.S. The extreme of that is Germany. We're having very good uptake in Spain and Italy. And of course, as I highlighted, France has done extraordinarily well just in 4 months to become the leading naïve and switch product. The other thing I should say, Alethia, is that Descovy in itself is doing very, very well in Europe. There are 1 or 2 markets that don't have the level of STRs that we have here in the United States, if you take somewhere like Germany. So Descovy itself is doing very well and we're happy to have that switch from Truvada to Descovy because it's a great platform for B/F/TAF in the future. So I think we're very pleased to be where we are, and I only see great momentum across the European countries.

Alethia，謝謝你的評論。是的，我們對本季的業績非常滿意。我認為各地區整體表現都很穩健。我們所有的產品都是──我也要向諾伯特致敬，感謝他在研發上所取得的令人矚目的成就。所以，我們對公司年中所取得的成就感到非常滿意。是的，Genvoya 現在開始在全國各地展出，展出的效果與我們在美國的效果相同。德國的情況最為突出。我們在西班牙和義大利的銷售情況非常好。當然，正如我所強調的那樣，法國在短短 4 個月內就取得了非凡的成就，成為領先的新手和轉換產品市場。阿萊西亞，我還要補充一點，Descovy 本身在歐洲發展得非常非常順利。如果你去德國這樣的地方看看，就會發現有一兩個市場的短期租賃市場沒有我們美國這裡的水平。所以 Descovy 本身表現得非常好，我們很高興能從 Truvada 切換到 Descovy，因為它是未來 B/F/TAF 的一個很棒的平台。所以我認為我們對目前所處的位置非常滿意，而且我看到歐洲各國的發展勢頭強勁。

Our next question comes from Brian Skorney with Robert Baird.

下一個問題來自 Brian Skorney 和 Robert Baird。

John, I know if I asked you what company you're going to buy, you would tell me but I think the market should keep guessing, so I'm going to ask something else. New diagnosis reads in HCV are pretty impressive, but I wondered if you could kind of characterize the trends you're seeing in access in the U.S. and maybe provide some characterization of what type of patients are being diagnosed. It never seemed like actual patient diagnosed volume is an issue, so are these patients being diagnosed? Or do you think they're accessible from the current payer situation and is the payer situation improving from your point of view?

約翰，我知道如果我問你打算收購哪家公司，你會告訴我，但我認為市場應該保持神秘感，所以我打算問你另一個問題。丙型肝炎的新診斷病例數相當驚人，但我想知道您是否可以描述一下您在美國看到的就醫趨勢，並或許可以對被診斷出的患者類型進行一些描述。實際確診患者數量似乎從來都不是問題，那麼這些患者是否都確診了？或者您認為從目前的支付方情況來看，這些服務是否可行？從您的角度來看，支付方情況是否有改善？

Maybe, Brian, I could start with that. We're not seeing a great deal of change. Pretty much, the patients are sort of, if you like, settling down. They are naïve to therapy, lower fibrosis scores. Generally, we have about the same access that we had in terms of start of the year. So there has not been any big fundamental changes. I think there are still a proportion of patients somewhere in the region of 20% to 25% who do get diagnosed with quite advanced disease. But on a general basis, they are fitter than the established patients that were there in doctors' offices and have been sat there for a long time, waiting for a new treatment. So that's kind of bad news/good news because we do eventually believe that they will come to the system and make this a long-term market for us.

或許，布萊恩，我可以從那裡開始。我們沒有看到太大的變化。基本上，患者們的情況正在逐漸穩定下來。他們未接受過治療，纖維化評分較低。整體而言，我們享有的資源與年初時基本相同。所以並沒有發生任何重大的根本性變化。我認為仍有大約 20% 到 25% 的患者在確診時已是相當晚期的疾病。但總的來說，他們的身體狀況比那些長期坐在醫生診間等待新療法的老病人還要好。所以這算是壞消息/好消息，因為我們最終相信他們會加入這個體系，並使之成為我們的長期市場。

I think my question was just really meant more around the new patients or, I mean, were you looking at the spike in patients or these dying patients that are diagnosed and who are incarcerated, or is it kind of heterogeneous and kind of the standard? So I want to know, is the patient -- is the spike in new diagnosis, is it actually going to pay off? Or is it in a patient population that's more or less inaccessible to branded products right now?

我覺得我的問題其實更多的是關於新患者，或者說，你是在關注患者數量的激增，還是那些被診斷出患有絕症並被監禁的患者，或者情況比較複雜，屬於正常情況？所以我想知道，患者——新診斷病例的激增，真的會帶來回報嗎？或者，這種情況是否發生在目前幾乎無法獲得品牌產品的患者群體中？

Brian, most of the folks who are seeking diagnosis are people who have access to very, very good medical care. This is not about incarceration. The rate of treatment of incarcerated individuals is still exceedingly low in this country, something that we're focusing on but have had very little traction on. So people who we're seeking -- essentially, the baby boomers we're seeking typically have very good healthcare or Medicare. And so, this is a very good, accessible population.

布萊恩，大多數來尋求診斷的人都是能夠獲得非常好的醫療服務的人。這與監禁無關。在這個國家，被監禁人員的治療率仍然極低，這是我們一直關注但卻收效甚微的問題。所以，我們正在尋找的人——基本上，我們正​​在尋找的嬰兒潮一代——通常都享有非常好的醫療保健或醫療保險。因此，這是一個非常好的、容易接觸到的人群。

Our next question comes from Robyn Karnauskas of Citibank.

下一個問題來自花旗銀行的 Robyn Karnauskas。

Maybe just a follow up and ask a little bit more about what's going on in the HIV market and who's switching who. Who is not switching to these new therapies in the United States? And what percentage of switch is coming from Triumeq or Tivicay regimens?

或許可以再追問一下，愛滋病毒市場的情況如何，以及哪些人正在更換供應商。在美國，哪些人沒有轉向這些新療法？其中有幾個比例的患者是從 Triumeq 或 Tivicay 療法轉而來？

Robyn, nice to hear your voice again. Congratulations on, I think, the addition to your family. Great to have you back. Really, the results are very positive across the board. As I said, about 30% of switches come to Genvoya. When you start to break down the rest of it, it tends to be a kind of a mishmash, a whole bunch of other switches. In terms of your question about how much of Genvoya comes from non-Gilead regimens, that's just over -- that's 10% to 11%, and that's stayed fairly constant since we launched Genvoya. So that's all additive to it, it's very positive and I think that will probably stay about where it is. So I wouldn't say there's any particular new dynamics. The switch continues to be the biggest part of the HIV markets, and Genvoya is clearly leading the products in the go-to switch regimen. Overall, I think we're just absolutely delighted that physicians see the benefit of having their patients on long-term TAF-based regimens. Good for the suppression of HIV and obviously, good for their kidneys and good for the bones.

羅賓，很高興能再次聽到你的聲音。我想，恭喜你們家添新成員了。歡迎回來真是太好了。事實上，各方面結果都非常正面。正如我所說，大約 30% 的交換器都來自 Genvoya。當你開始分析其餘部分時，你會發現它往往是一團亂麻，包含了許多其他的開關。關於您提出的 Genvoya 中有多少來自非吉利德療法的問題，這個比例略高於 10% 到 11%，而且自 Genvoya 上市以來一直保持相對穩定。所以這些都是正面的因素，而且我認為它可能會維持現狀。所以我覺得沒有什麼特別的新改變。轉換療法仍然是 HIV 市場中佔比最大的部分，而 Genvoya 顯然在首選轉換療法產品中處於領先地位。總的來說，我們非常高興看到醫生們認識到讓患者長期接受 TAF 治療方案的好處。有利於抑制愛滋病毒，顯然對腎臟和骨骼也有好處。

And as a follow-up, do you think there's anyone that -- do you have a sense yet that there's a percentage of people that you will not be able to switch? Or when do you think you'll have a good sense of maybe a part of the market that will not be switching to these new therapies? Will it take the launch of B/F/TAF for you to understand that? Or do you think you kind of have a sense of that right now?

作為後續問題，您認為是否有人—您是否已經感覺到有一部分人您無法讓他們改變？或者，您認為什麼時候才能清楚地了解市場中哪些部分不會轉向這些新療法？難道非要等到B/F/TAF發布之後才能明白嗎？或是你覺得你現在多少有點這種感覺？

Well, we do hope Genvoya is going to keep going up until we bring in B/F/TAF in 2018. Robyn, there's some patients who are just very familiar with their therapies. I dare say there's still going to be some Atripla patients, Stribild patients, Complera patients. They're just comfortable. Even after discussion with their physicians, sometimes patients don't want to switch. And also, don't forget, you've got a smaller proportion of patients who are on the PI regimens. And sometimes, physicians who feel that they perhaps might not be quite as adherent prefer them to be on a PI-based regimen. So they may not be the patients who come across.

我們希望 Genvoya 的價格能夠持續上漲，直到我們在 2018 年引入 B/F/TAF。羅賓，有些病人對自己的治療方案非常熟悉。我敢說，仍然會有一些 Atripla 患者、Stribild 患者和 Complera 患者。它們穿著很舒服。即使與醫生討論過，有時患者也不願意更換治療方案。還有，別忘了，接受 PI 治療方案的患者比例較小。有時，有些醫生認為患者可能不太能堅持治療，因此更傾向於讓患者接受以蛋白酶抑制劑為基礎的治療方案。所以他們可能不是會遇到的病人。

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。

Wanted to go back to HIV again. And in some of the doublet data that was presented at IAS, there was a very small subset of patients that experienced resistance mutations secondary to extreme non-adherence. I'm curious as to your views on this and whether you think it's a meaningful finding or just noise.

想再回到愛滋病研究領域。在 IAS 上展示的一些雙聯體數據中，有一小部分患者由於極度不依從治療而出現了抗藥性突變。我很想知道你對此有何看法，你認為這是一個有意義的發現還是只是噪音。

Yes, Cory, thanks for the question, it's Norbert. There is no doubt that both dolutegravir and 3TC are proven, long-term, tolerable and safe drugs. The question that everybody has, are the 2 by themselves enough to chronically suppress virus replication in a broad patient population, irrespective of baseline viral load and irrespective of partial adherence? And I think the data that were presented at the IAS ACTG A5353 has put that into doubt. And even though these patients were non-adherent, there's one especially that developed the 263 mutation. The fact that is this is real life, these patients do exist, not all patients are adherent all the time. And we just have to wait for long-term, 2-year data to really answer this question. By the way, if you look at the detailed slides, there were actually 5 patients that had virological failure if you use the FDA definition of greater than 50 copies per mil at week 24. And it was at week 24 analysis. So again, it -- we need to see more data and I know that Phase II study, 3 studies are ongoing, the Gemini studies. And hopefully, we'll get the answer from that. But as I said at this point, I have great doubts whether that dolutegravir 3TC is enough to cover a broad patient population.

是的，科里，謝謝你的提問，我是諾伯特。毫無疑問，多替拉韋和 3TC 都是經過驗證的、長期有效、耐受性良好且安全的藥物。大家最關心的問題是，這兩種方法本身是否足以在廣泛的患者群體中長期抑制病毒複製，而不管基線病毒量如何，也不管患者是否部分依從？我認為在 IAS ACTG A5353 會議上提出的數據已經使這一點受到質疑。儘管這些患者都不遵醫囑，但其中有一位患者出現了 263 突變。事實是，這是現實生活，這類病人確實存在，並非所有病人都能始終堅持治療。我們只需要等待長達兩年的數據才能真正回答這個問題。順便說一下，如果你查看詳細的幻燈片，你會發現，如果按照 FDA 的定義（第 24 週每百萬拷貝數大於 50），實際上有 5 名患者出現了病毒學失敗。這是在第 24 週的分析中得出的結論。所以，我們還是需要看到更多的數據，我知道目前正在進行 II 期研究、3 項研究，也就是 Gemini 研究。希望我們能從中找到答案。但正如我剛才所說，我非常懷疑多替拉韋（3TC）是否足以涵蓋廣泛的患者群體。

Cory, Kevin here. If you get virological failure and resistance in a controlled clinical setting in a study, then I don't know what might happen in real life. It's important to say that with the large numbers of HIV patients that are treated these days, many have quite chaotic personal lives in terms of housing and the need for social care. And they are very challenged and I think it's important that those type of patients really do get robust therapies that do our very best to avoid them getting into difficult situations of failure.

科里，我是凱文。如果在受控的臨床研究中出現病毒學失敗和抗藥性，那麼我不知道在現實生活中會發生什麼。值得一提的是，如今接受治療的愛滋病患者數量龐大，其中許多人在住房和社會照護需求方面都面臨著相當混亂的個人生活。他們面臨著巨大的挑戰，我認為對於這類患者來說，獲得強而有力的治療至關重要，我們必須盡最大努力避免他們陷入治療失敗的困境。

Our next question comes from Ying Huang with Bank of America Merrill Lynch.

下一個問題來自美國銀行美林證券的黃穎。

Maybe first one is for Norbert. We heard from some physicians attending IAS this week that there is a small but potentially meaningful difference in CNS side effects, such as sleep quality or disturbance or insomnia. How meaningful is that in the real practice? You think that you can make a differentiation between bictegravir and the Tivicay or Triumeq regimen? And then secondly, maybe for Kevin. We're expecting AbbVie to obtain FDA approval probably this quarter for their once-daily, one-pill regimen for HCV. What's your outlook for market share and also the pricing dynamics once AbbVie enters the market within another one-pill, once-daily regimen for HCV?

或許第一個是給諾伯特的。本週我們從一些參加 IAS 的醫生那裡了解到，中樞神經系統副作用方面存在一些雖小但可能意義重大的差異，例如睡眠品質或睡眠障礙或失眠。這在實際應用上有多大意義？你認為你能區分比克替拉韋和Tivicay或Triumeq療法嗎？其次，或許是為了凱文。我們預計艾伯維公司（AbbVie）的丙型肝炎每日一次、單片療法可能在本季獲得 FDA 批准。您認為艾伯維推出另一種每日一次、單片裝的C型肝炎治療方案後，市佔率和定價動態會如何改變？

So Ying, in study 1489 which was the Triumeq to bictegravir B/F/TAF comparison, there were clearly more adverse -- self-reported adverse events that had to do with sleep disturbance, nausea, et cetera, on the abacavir-containing arm. But in the second study, 1490, the incidence was similar. So our interpretation is that what we are seeing in terms of CNS-related effects and constitutional chain of well-being has to do with abacavir. The comparison of bictegravir to dolutegravir did not really show a difference. And I cannot, at this point, tell you what bictegravir does in terms of CNS side effects.

所以 Ying，在 Triumeq 與 bictegravir B/F/TAF 的比較研究 1489 中，含阿巴卡韋組的不良反應（自我報告的不良事件）明顯更多，這些不良反應與睡眠障礙、噁心等有關。但在第二項研究（1490 年）中，發生率相似。因此，我們的解釋是，我們所看到的與中樞神經系統相關的效應和整體健康狀況與阿巴卡韋有關。比克替拉韋與多替拉韋的比較並沒有顯示出真正的差異。目前我無法告訴你比克替拉韋在中樞神經系統副作用方面的作用。

Ying, it's Kevin. In answer to your question, we just don't know. We're just sort of 2 weeks before their FDA PDUFA date, we'll just have to cross some bridges when we see their label, we see their pricing, we see how they begin to promote the product. Perhaps eventually see how they come on the market with their contracting strategy. So I think there are unknowns and we'll just have to wait and see. I can only really control the areas that we have with our products. And I think we feel reassured by the portfolio of HCV products and now, we have Vosevi added to that. I think we have a tremendous offering in genotype 1, 2 and 3. Epclusa, as Robin mentioned, is doing really, really well, both here and now, it's coming on-stream in Europe. And we'll be able to also help the small number of patients who failed at their therapies with Vosevi. So I think we're in a good position and we're certainly going to continue with our very, very, very solid and very substantial promotion of our products.

瑩，我是凱文。對於你的問題，我們真的不知道。距離他們獲得 FDA PDUFA 批准還有大約兩週時間，等我們看到他們的標籤、定價以及他們開始推廣產品的方式時，我們還需要克服一些障礙。或許最終能看到他們如何憑藉其承包策略進入市場。所以我覺得還有很多未知因素，我們只能拭目以待了。我只能真正控制我們產品所在的領域。我認為我們對現有的 HCV 產品組合感到放心，現在，Vosevi 也加入了其中。我認為我們在基因型 1、2 和 3 方面提供了非常出色的產品。正如 Robin 所提到的，Epclusa 目前發展得非常好，無論是在這裡還是現在，它都即將在歐洲上市。我們也能幫助少數使用 Vosevi 治療失敗的患者。所以我認為我們處境不錯，我們肯定會繼續非常、非常、非常穩健、非常有力地推廣我們的產品。

Ying, I would like to add. If you look at the data that on [gleeb bib] they had excellent clinical results in genotype 1 in treatment-naïve, very early disease, mostly F0 and F1. Actually, 80% of the population was F0 and F1 and in treatment-naïve patients. But the data in the other genotypes and also in treatment experienced in cirrhotic patients was less good. Particularly, if we look at genotype 3, where they compared 8 weeks to 12 weeks to 12 weeks of sofosbuvir, daclatasvir, the regimen that had the most virological failures was the 8 weeks of the AbbVie dual, followed by the 12 weeks of the AbbVie dual. And the best-performing regimen was actually sofosbuvir, daclatasvir. So as Kevin said, we just have to really look at what the U.S. label will look like, then we will be in a better position to comment on the competitive nature.

穎，我想補充一點。如果你查看[gleeb bib]的數據，你會發現他們在基因型 1 的未經治療的早期疾病（主要是 F0 和 F1）中取得了優異的臨床結果。事實上，80% 的人口為 F0 和 F1 期，且均為初治患者。但其他基因型的數據以及肝硬化患者的治療經驗都不太理想。特別是，如果我們觀察基因型 3，他們比較了 8 週、12 週和 12 週的索非布韋、達卡他韋方案，結果發現病毒學失敗最多的方案是艾伯維雙藥 8 週方案，其次是艾伯維雙藥 12 週方案。而療效最好的方案其實是索非布韋和達克拉他韋。正如凱文所說，我們只需要真正看看美國標籤會是什麼樣子，然後我們才能更好地評論競爭性質。

Our next question comes from Michael Yee with Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

I have 2 R&D questions. One is on filgotinib, where you mentioned there was an interim analysis in UC in the first half of '18. Can you just remind us a bit on that and what the importance is of that in terms of that interim? And then secondly on FXR, you have a Phase II coming up soon in PBC. I wanted to understand your confidence in terms of efficacy and differentiation and what you would want to see to move forward in NASH.

我有兩個研發方面的問題。其中之一是 filgotinib，您提到在 2018 年上半年對 UC 進行了中期分析。您能否再簡單回顧一下這方面的內容，以及它在這段過渡時期的重要性？其次，FXR 在 PBC 即將推出二期專案。我想了解您對療效和差異化的信心，以及您希望在 NASH 領域看到哪些進展。

Thank you, Michael. No, the interim analysis was not on filgotinib. It was on the MMP-9 antibody andecaliximab. And that interim analysis is an analysis when we will have reached 30% of the endpoints, and the endpoint is death. So it's overall survival and that will happen in the second -- later this year, and we have a hazard ratio prespecified. So it's more a futility analysis. If we don't reach a minimal hazard ratio, then we will probably discontinue the study. But if the DSMB sees that hazard ratio reached, they will simply recommend to continue the study. And to think...

謝謝你，麥可。不，中期分析並非針對filgotinib。它與 MMP-9 抗體 andecaliximab 有關。中期分析是指在達到 30% 的終點指標時進行的分析，終點指標為死亡。所以，這是總體生存率，這將在第二階段——今年晚些時候——發生，我們已經預先設定了風險比。所以這更像是徒勞分析。如果達不到最低風險比，我們可能會終止這項研究。但如果資料安全監測委員會 (DSMB) 發現達到了這個風險比，他們就會建議繼續進行研究。想想看…

Maybe I'm just reading it wrong on Slide 51, so I'll follow-up with you on the top there since filgotinib Phase III is interim, but we'll keep going.

也許我對第 51 張投影片的理解有誤，所以我會在那裡跟你確認一下，因為 filgotinib 的 III 期臨床試驗是中期試驗，但我們會繼續進行下去。

Okay. Yes, we'll follow up with you afterwards. I don't have Slide 51. And the other question you had is about FXR agonist in PBC. We just have to see what the data looks like. But as you know or may know, we are differentiated in terms of mechanism because we rely on intestinally generated FGF19 to essentially give you the efficacy. And we think some of the side effects that have been seen with the other FXR agonists may have to do with systemic FXR agonism. It's all hypothesis and the initial data that we have would actually support it. But if we were to see this, we could have an agent that is differentiated from a safety point of view. And the other thing you may probably also know, the compound that's approved currently has pretty severe limitations with regards to hepatic impairment. I think it has to be given, is it once a week? I don't remember but it's great -- it greatly increases the concentration of the OCA. So those are the 2 areas of differentiation.

好的。是的，之後我們會與您聯絡。我沒有第51張投影片。你提出的另一個問題是關於 FXR 激動劑在 PBC 中的應用。我們只需要看看數據是什麼樣的。但正如您所知或可能知道的那樣，我們在機制上有所不同，因為我們依靠腸道產生的 FGF19 來發揮療效。我們認為，其他 FXR 激動劑的一些副作用可能與全身性 FXR 激動作用有關。這都只是假設，而我們目前掌握的數據其實支持這個假設。但如果我們看到這一點，我們就可以擁有一個從安全角度來看與眾不同的代理商。還有一點你可能也知道，目前核准的化合物在肝功能損害方面有相當嚴重的限制。我認為必須給予，是每週一次嗎？我不記得了，但是效果很好——它大大提高了OCA的濃度。所以，這就是兩個不同之處。

Our next question comes from Phil Nadeau with Cowen and Company.

我們的下一個問題來自 Cowen and Company 的 Phil Nadeau。

One question on bictegravir's data that was presented earlier this week. When GSK was asked about bictegravir this morning, they highlighted the numeric differences, embryologic suppression that were seen in study 1490. Although those differences weren't statistically significant, I guess, along those lines, one, to what do you attribute these differences? Two, how successful do you think you'll be in convincing physicians that they're not significant, using things like the missing excluded analysis that you showed in the poster? And three, do you expect them to be on the label?

本週早些時候公佈的關於比克替拉韋的數據有一個問題。今天早上當葛蘭素史克被問及比克替拉韋時，他們強調了在 1490 號研究中觀察到的數值差異和胚胎抑制。雖然這些差異在統計上並不顯著，但我想，沿著這個思路，首先，你認為這些差異是由什麼造成的？第二，你認為你有多大可能說服醫生相信這些因素並不重要，例如你海報中所呈現的缺失排除分析之類的例子？第三，你希望它們出現在標籤上嗎？

So Phil, this actually very simple. You can have virological failure. There are 3 categories that fall into this. #1, you come in at the week 48 visit, and you truly have about 50 copies per mil, that's one virological failure. The second is if you discontinue and the physician indicates on the discontinuation form that you have discontinued for the lack of efficacy, that's #2. And the third category is if you have discontinued at any point in time for administrative reason and your last measurement was greater than 50. And now, look at that third category. We had a total of 11 patients on the bictegravir arm versus 3 on the dolutegravir arm that discontinued due to administrative reason. And out of those 11, by the way, 6 only showed up at the first visit. So they showed up, first visit, took the drug, then we never saw them again. And the reason was various. They moved out of the area, they couldn't be reached anymore, they were incarcerated, things like that. So we think this is completely a nonissue and we will have no problems at all convincing physicians that this doesn't matter. These numbers will be in the label, absolutely. This is how FDA, in all HIV drugs, in all Phase III data categorize this thing but it will be categorized exactly this. Virological failure due to #1; two, virological failure, discontinued due to lack of efficacy; and #3, and that's the category I want to point your attention to, discontinued for other reasons and last measurement was greater than 50.

菲爾，其實這很簡單。可能會出現病毒學失敗。這可以分為三類。#1，當你在第 48 週復診時，病毒量確實約為每百萬 50 個拷貝，這就是一次病毒學失敗。第二種情況是，如果您停止用藥，而醫師在停藥單上註明您因療效不佳而停止用藥，那就是第 2 種情況。第三類情況是，如果您因行政原因在任何時候停止測量，並且您的最後一次測量值大於 50。現在，我們來看看第三類。比克替拉韋組共有 11 名患者因行政原因中止治療，而多替拉韋組則有 3 名患者中止治療。順便一提，這 11 人中，有 6 人只參加了第一次訪問。所以他們來了，第一次來，服用了藥物，然後我們就再也沒見過他們了。原因有很多。他們搬離了那個地區，聯繫不上了，他們被監禁了，諸如此類的事情。所以我們認為這完全不是問題，我們完全可以毫無問題地說服醫生們，這無關緊要。這些數字肯定會出現在標籤上。這就是FDA在所有HIV藥物、所有III期臨床試驗數據中對這種藥物的分類方式，但它最終的分類也將完全如此。病毒學失敗，原因有三：1. 病毒學失敗；2. 病毒學失敗，因療效不足而停止治療；3. 這也是我想讓大家注意的類別，因其他原因停止治療，最後一次測量結果大於 50。

Phil, it's Kevin, just to also add. The real, the #1 headline that is most important to opinion leaders and therefore, the HIV community, is 0 resistance. And we have met with our KOLs, that is where they go to first, it's 0 resistance. And of course, that is unlike the situation that occurred in ACTG 5353.

菲爾，我是凱文，補充一下。真正重要、對意見領袖和愛滋病群體而言最重要的頭條新聞是：零抵抗。我們已經和我們的KOL（關鍵意見領袖）會面了，他們首先會來找我們，阻力為零。當然，這與 ACTG 5353 中發生的情況截然不同。

Phil, another comment. You would, of course, expect in a large study like this that these random events would equally distribute between the 2 arms. Well, they didn't. As I said, there were 11 on our -- on the bictegravir arm versus 3 on the other arm. It's purely statistical coincidence and has no meaning whatsoever clinically.

菲爾，還有一則評論。當然，像這樣的大型研究，你會期望這些隨機事件在兩組之間均勻分佈。然而，他們並沒有。正如我所說，我們這組（比克替拉韋組）有 11 例，而另一組只有 3 例。這純粹是統計上的巧合，沒有任何臨床意義。

Our next question comes from Terence Flynn with Goldman Sachs.

下一個問題來自高盛的 Terence Flynn。

Just was wondering, John, if you can give us any update on your latest thoughts on business development, specifically if there have been any changes with respect to either areas of focus or stage of development.

約翰，我想問你，能否就業務發展方面的最新想法提供一些信息，特別是關於重點領域或發展階段是否有任何變化。

Yes, thanks, Terence. The quick answer is no. There hasn't been any difference in what we're thinking about. So have been very, very active, as we always are. We have beefed up our groups, as you're aware, so that we can evaluate more different kinds of opportunities. And so, we are working very hard behind the scenes on a number of things. But I certainly can't direct you to anything specific other than to say that we're very, very active. And when the things are right for us, we'll announce them. That's all I can say.

是的，謝謝你，特倫斯。簡而言之，答案是否定的。我們的想法沒有任何改變。所以，我們一直都非常非常活躍，就像我們一直以來那樣。如您所知，我們已經加強了團隊建設，以便評估更多不同類型的機會。因此，我們正在幕後努力處理很多事情。但我除了說我們非常非常活躍之外，肯定無法提供任何具體資訊。時機成熟時，我們會宣布的。我只能說這麼多了。

Our next question comes from Ian Somaiya with BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Ian Somaiya。

Really just a question on the PrEP opportunity. If you could just quantify for us what the opportunity is today, whether it's in patient terms or dollar terms. And as you think about the Discover study, what does that trial need to show for you to effectively transition these patients from Truvada to Descovy?

我只是想問一下關於PrEP（暴露前預防）的機會。如果您能為我們量化一下目前的機會是什麼，無論是以患者數量還是金錢數量來衡量，那就太好了。當您考慮 Discover 研究時，該試驗需要證明什麼，才能有效地將這些患者從 Truvada 過渡到 Descovy？

Ian, it's Kevin. I'll let Norbert answer the question on the Descovy study. But in terms just generally, compared with a few years ago, it's quite remarkable now how people are taking onboard the benefits of PrEP and obviously, avoiding infection. We've seen some remarkable work here in San Francisco, we see a lot of activity in New York, Miami. And we have taken those signals and have put a larger, field-based team out there to try and support the education around PrEP. So we're able to visit places like now like Atlanta, Washington DC and many other urban areas. About half of our Truvada sales in the U.S. are currently coming from PrEP, and we certainly expect that to grow. If you look at our numbers this year compared with 2016, we're about 15% higher in terms of the use of Truvada for PrEP. And the other part of this is it's not occasional monthly use of Truvada. We're starting to see persistency at the patient level that is close to matching normal HIV use of Truvada. So we're seeing a chronicity, a regular use among PrEP-using individuals. And the final thing I would say, Ian, is that we are seeing other parties starting to announce that for example, retail pharmacies are beginning initiatives that their pharmacists can engage in conversations on PrEP and what PrEP is about and educate people who come into a retail pharmacy to ask about PrEP medications. So that's also, I think, part of the momentum and movement that's going on right now.

伊恩，我是凱文。關於 Descovy 研究的問題，就請 Norbert 來回答吧。但總的來說，與幾年前相比，現在人們對 PrEP 的好處以及避免感染的接受程度非常高，這真是令人矚目。我們在舊金山看到了一些非常出色的工作，在紐約和邁阿密也看到了很多活動。我們已經注意到這些訊號，並派出一支規模更大的實地團隊去支持 PrEP 相關的教育工作。所以我們現在能夠去亞特蘭大、華盛頓特區以及許多其他城市地區旅行。目前，我們在美國銷售的 Truvada 產品中約有一半來自 PrEP，我們當然預期這一數字還會成長。如果將我們今年的數據與 2016 年的數據進行比較，就會發現 Truvada 用於 PrEP 的使用率提高了約 15%。另一方面，這不是偶爾每月服用 Truvada。我們開始看到患者層面的堅持性接近正常 HIV 患者使用 Truvada 的情況。因此，我們看到的是 PrEP 使用者中普遍存在的慢性、常規使用現象。最後我想說的是，伊恩，我們看到其他方面也開始宣布，例如，零售藥局正在啟動一些舉措，讓他們的藥劑師可以參與到關於 PrEP 的對話中，解釋 PrEP 的含義，並教育那些到零售藥店詢問 PrEP 藥物的人。所以，我認為這也是目前正在發生的勢頭和運動的一部分。

Yes, Ian, from a clinical point of view, it's very simple, it's a non-inferiority study. We want to simply show that regarding efficacy-wise, that F/TAF is the same as Truvada, along with improved renal and bone parameters. And then because it's much easier and safer to use, you don't have to monitor creatinine, you don't have to look for people that are at risk for bone defects, you don't have to measure BMD, that it's a much preferred agent to Truvada. That's essentially what we're showing. And that's what it -- why it takes 5,000 patients. By the way, it's not a small study to do.

是的，伊恩，從臨床角度來看，這很簡單，這是一項非劣效性研究。我們只想證明，就療效而言，F/TAF 與 Truvada 相同，腎臟和骨骼參數有所改善。而且，由於它使用起來更方便、更安全，無需監測肌酸酐，無需尋找有骨骼缺陷風險的人，無需測量骨密度，因此它是比 Truvada 更受歡迎的藥物。這就是我們基本上要展示的內容。這就是為什麼需要 5000 名患者的原因。順便說一句，這項研究規模並不小。

Right. I guess, Norbert, what I was trying to understand is, is the patient sensitivity any different? Are they more sensitive or less sensitive to the adverse event profile of TAF, given that they obviously don't carry the infection?

正確的。諾伯特，我想了解的是，病人的敏感度是否有所不同？考慮到他們顯然沒有感染，他們對 TAF 的不良反應特徵是更敏感還是更不敏感？

No, actually, Ian, that -- so I don't have those data yet but we answered that question when we did the PrEP studies with Truvada. There was a question that both we and FDA had. And the question was, can you take safety data from HIV-infected individuals and extrapolate the non-HIV infected? And the conclusion was you can't. So we generated data in about, I can't remember, 25,000 patients total that were not HIV-infected. And that database convinced everybody that safety is the same. There's no difference between HIV-infected and non-HIV-infected patients.

不，實際上，伊恩，那個——我還沒有那些數據，但是我們在用 Truvada 進行 PrEP 研究時已經回答了這個問題。我們和FDA都有一個共同的疑問。問題是，能否利用 HIV 感染者的安全資料推斷未感染 HIV 者的安全資料？結論是：你做不到。因此，我們收集了大約 25,000 名未感染 HIV 的患者的數據，具體數字我記不清了。而這個資料庫讓所有人相信，安全都是一樣的。感染愛滋病毒的患者和未感染愛滋病毒的患者之間沒有區別。

Our next question comes from Salim Syed with Mizuho.

下一個問題來自瑞穗銀行的Salim Syed。

Just on -- when we're thinking about detail for hepatitis C, I don't think you've put out these numbers in a while. But correct me if I'm wrong, there's 1.4 million patients treated and there was 4 million to begin with in the U.S. And people have previously thought there was 500,000 that are uninsured and untreated. Of the remaining 2 points -- of the 2.6 million of which the 500,000 is part of, is there any other patient population that you guys have had more time passed that's not treatable here or reasonably treatable?

順便一提——當我們考慮丙型肝炎的細節時，我想你們已經很久沒有公佈這些數據了。但如果我沒記錯的話，目前有 140 萬患者接受了治療，而美國最初的患者人數為 400 萬。此前人們認為有 50 萬患者沒有保險，也沒有接受治療。剩下的 2 點——在 260 萬（其中 50 萬是其中的一部分）中，你們是否還有其他患者群體，他們的治療時間更長，但在這裡無法治療或無法合理治療？

Salim, it's Kevin. We've always, in the U.S., go in the figures that are about 3 million infected and about 1.5 million that are diagnosed. No, I don't think there's any sort of difference in our opinions of the market. There is a proportion of patients studies that is uninsured. There are a group of patients that are incarcerated. As John said earlier, we don't -- we see very little treatment. We continue our conversations with the various states around their systems of incarceration, but there doesn't seem to be much momentum about that. We talked in the past about, obviously, the VA. The VA has been incredibly proactive, they have dedicated money. We are hearing -- we don't have direct data but we're hearing that it is slowing down a little bit like the general markets, but they continue their efforts to outbound information and trying to get people into the system. They're incredibly enthusiastic to try and cure their veterans. And there's the continuation, as John said, of the commercial markets. And we certainly are doing our part to try and highlight to patients the need to be tested and that there are very comprehensive ways of curing the disease. So I think, first, to continue to do that at some point, at some point, there will be some equilibrium, and that will still be a lot of patients. And the with an incredible treatment that cures, payers, providers will be motivated to use therapies. So I don't think there's been any big a-has for us or particular opening of new patient groups in the past 12 months.

薩利姆，我是凱文。在美國，我們一直以來都採用這樣的數字：大約有 300 萬人感染，其中約有 150 萬人被確診。不，我認為我們對市場的看法沒有任何分歧。研究發現，有一部分患者沒有醫療保險。有一群病人被監禁了。正如約翰之前所說，我們很少看到治療案例。我們繼續與各州就其監禁制度進行對話，但似乎並沒有取得太大進展。我們之前當然也談過退伍軍人事務部。退伍軍人事務部一直非常積極主動，他們已經投入了資金。我們聽說——我們沒有直接數據，但我們聽說它像整體市場一樣略有放緩，但他們仍在努力對外發布信息，並試圖讓人們加入該系統。他們非常熱衷於嘗試治癒退伍軍人。正如約翰所說，商業市場也將繼續存在。我們當然也在盡自己的一份力，努力向患者強調接受檢測的必要性，以及治癒這種疾病的全面方法。所以我認為，首先，繼續這樣做，在某個時候，會達到某種平衡，屆時仍然會有很多病人。而有了能夠治癒疾病的神奇療法，支付方和醫療服務提供者就會有動力去使用這種療法。所以我覺得在過去的 12 個月裡，我們並沒有什麼重大的突破，也沒有任何新的病患群體出現。

Our next question comes from the line of Carter Gould with UBS.

我們的下一個問題來自瑞銀集團的卡特古爾德。

I guess, Kevin, on the Get Tested campaign, is the expectation that screening volumes will still continue to grow meaningfully? Or should we expect that impact to plateau? And is it safe to say that program will continue unchanged when AbbVie enters the market?

凱文，我想，在「接受檢測」活動中，是否預期篩檢量將繼續顯著增長？或者我們應該預期這種影響會趨於平穩？那麼，當艾伯維進入市場後，該計劃是否會保持不變地繼續下去？

Good question, Carter. I don't know. We could go higher. We always feel that part of our role in the areas, in our large areas that we operate is to provide education. As a reminder, our baby boomer campaign is not ahead as much as our Harvoni campaign. But I think in general terms, yes, we feel that it is important to continue to highlight that baby boomers potentially who have been in a situation of risk, that they might go and ask for a test and be screened and find out their status. I mean, let's not forget that our principle is backed by the CDC and there are -- there's Gilead and there are many other parties that support baby boomers finding out their HCV status. And if they are positive then, to take the steps forward. So yes, we feel that as the leader in HCV, is part and parcel of the role we play.

問得好，卡特。我不知道。我們還可以更高。我們始終認為，在我們營運的廣大地區，我們的部分職責是提供教育。再次提醒大家，我們的嬰兒潮世代宣傳活動進展不如我們的哈沃尼宣傳活動順利。但總的來說，我認為有必要繼續強調，那些可能處於風險之中的嬰兒潮世代，應該主動要求進行檢測和篩檢，以了解自己的健康狀況。我的意思是，別忘了我們的原則得到了美國疾病管制與預防中心的支持，還有吉利德公司以及許多其他團體支持嬰兒潮世代了解自己的C型肝炎病毒感染狀況。如果結果呈陽性，那就採取下一步措施。所以，是的，我們認為身為丙型肝炎領域的領導者，這是我們職責不可或缺的一部分。

And that concludes today's question and answer session. I'd like to turn the call back to Mr. Lee for any closing remarks.

今天的問答環節到此結束。我想把電話轉回給李先生，請他作總結發言。

Great. Thank you, Liz, 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。謝謝你，莉茲，也謝謝今天所有到場的各位。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。