吉利德科學 (GILD) 2017 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences First Quarter 2017 Earnings Conference Call. My name is Candice, and I'll be your conference operator today. (Operator Instructions) As a reminder, this conference call is being recording.

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年第一季財報電話會議。我叫坎迪斯，今天我將擔任你們的會議接線生。（操作員說明）提醒各位，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。

Great. Thank you, Candice, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2017. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

偉大的。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 年第一季的獲利結果。新聞稿和詳細幻燈片可在吉利德公司網站的投資者關係部分查看。

In addition, this year, we have combined our annual and corporate social responsibility reports into a single publication titled 2016 Year-End Review to share essential information about the company's financial, social, environmental and governance performance. This report can be found on the Investor Relations section of our website.

此外，今年我們將年度報告和企業社會責任報告合併為一份名為《2016 年終回顧》的出版物，以分享有關公司財務、社會、環境和治理績效的重要資訊。這份報告可在我們網站的投資人關係欄位中找到。

The speakers on today's call will be John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; Jim Meyers, Executive Vice President, Commercial Operations. Also in the room with us for the Q&A session are Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer; and Kevin Young, Chief Operating Officer.

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；執行副總裁兼商業營運主管吉姆·邁耶斯。與我們一同參加問答環節的還有研發執行副總裁兼首席科學官諾伯特·比肖夫伯格，以及營運長凱文·楊。

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 the 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 on our first quarter. I'll review our financial results, Jim will elaborate on our commercial performance, and then, John will make a few comments.

謝謝宋，大家午安。我們很高興向您報告第一季的工作情況。我將回顧我們的財務業績，吉姆將詳細介紹我們的商業表現，然後，約翰將發表一些評論。

There were a number of positive trends from our non-HCV business in the first quarter that Jim will describe in a few minutes.

第一季度，我們的非丙型肝炎業務出現了一些積極的趨勢，吉姆將在幾分鐘後對此進行介紹。

Overall, earnings per share and the total revenues were down year-over-year, due primarily to dynamics in the HCV marketplace that we described during our last earnings call. Total revenues for the first quarter were $6.5 billion, with non-GAAP diluted earnings per share of $2.23. This compares to revenues of $7.8 billion and non-GAAP earnings per share of $3.03 for the same period last year.

總體而言，每股盈餘和總營收年減，這主要是由於我們在上次財報電話會議上所描述的 HCV 市場動態所致。第一季總收入為 65 億美元，非 GAAP 稀釋後每股收益為 2.23 美元。相比之下，去年同期營收為 78 億美元，非 GAAP 每股收益為 3.03 美元。

Product sales for the first quarter were $6.4 billion, down 17% year-over-year and down 12% sequentially. The year-over-year decline was due to lower HCV sales, partially offset by increased sales in HIV and other therapeutic areas. Sequentially, the decline was due to lower HCV sales and sub-wholesaler inventory decreases in the U.S., associated with our non-HCV franchises, reflective of the seasonal inventory pattern from the fourth quarter to the first quarter.

第一季產品銷售額為 64 億美元，年減 17%，季減 12%。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。從順序上看，下降的原因是 HCV 銷售額降低以及美國分銷商庫存減少，這與我們非 HCV 特許經營業務有關，反映了從第四季度到第一季的季節性庫存模式。

Turning to the U.S. Product sales for the first quarter were $4.5 billion, up 2% year-over-year and down 10% sequentially. Jim will provide more color for the U.S. as well as the other regions.

再來看美國市場。第一季產品銷售額為 45 億美元，年增 2%，季減 10%。吉姆將為美國以及其他地區帶來更多色彩。

Turning to Europe. Product sales for the first quarter were $1.3 billion, down 23% year-over-year and down 11% sequentially, primarily due to competitive dynamics in HCV and unfavorable currency movements.

轉向歐洲。第一季產品銷售額為 13 億美元，年減 23%，季減 11%，主要原因是丙型肝炎病毒 (HCV) 市場的競爭格局和不利的匯率波動。

Now turning to expenses. Non-GAAP research and development expenses were $889 million for the first quarter, up 16% compared to the same period last year, due primarily to the purchase of a $125 million U.S. FDA priority review voucher in March.

現在來說說費用。第一季非GAAP研發費用為8.89億美元，比去年同期成長16%，主要是由於3月購買了價值1.25億美元的美國FDA優先審查券。

Non-GAAP SG&A expenses were $807 million for the first quarter compared to $638 million in the same period last year. These expenses increased primarily due to a higher net Branded Prescription Drug fee for the first quarter of 2017 compared to the first quarter of 2016, which included a $191 million favorable adjustment, as referenced on Slide 11. Without this onetime adjustment, non-GAAP SG&A expenses for the quarter would have been slightly lower compared to the first quarter of 2016.

第一季非GAAP銷售、管理及行政費用為8.07億美元，去年同期為6.38億美元。這些支出增加主要是由於 2017 年第一季品牌處方藥淨收入比 2016 年第一季有所增加，其中包括 1.91 億美元的有利調整，如投影片 11 所述。如果沒有這項一次性調整，本季的非GAAP SG&A費用將比2016年第一季略低。

We continue to focus our efforts on operating in a highly efficient manner by proactively managing expenses and investing in areas of strategic importance to retain our industry-leading operating margins, significant cash flows and healthy balance sheet.

我們將繼續致力於高效運營，積極管理支出，並投資於具有戰略意義的領域，以保持行業領先的營運利潤率、可觀的現金流和健康的資產負債表。

During the quarter, we generated cash flows from operations of $2.9 billion and ended the quarter with $34 billion in cash and investments. As part of our plan to return capital to our shareholders, in the first quarter, we paid cash dividends of $687 million and repurchased 7.9 million shares of stock for $565 million. The timing and amount of share repurchases was aligned to our stock compensation awards, which are largely granted in the first quarter. As noted in our last earnings call, we are prioritizing the use of capital for investing in the long-term growth of our business, including partnerships and acquisitions.

本季度，我們透過經營活動產生了 29 億美元的現金流，季度末我們擁有 340 億美元的現金和投資。作為我們向股東返還資本計畫的一部分，在第一季度，我們支付了 6.87 億美元的現金股息，並以 5.65 億美元的價格回購了 790 萬股股票。股票回購的時機和數量與我們的股票薪酬獎勵計劃一致，這些獎勵計劃大多在第一季授予。正如我們在上次財報電話會議上所提到的，我們將優先利用資金投資於我們業務的長期成長，包括合作和收購。

The year is progressing consistent with our expectations. As such, we are reiterating our full year 2017 guidance provided to you on February 7 and summarized on Slide 7 in the earnings results presentation available on our corporate website.

今年的進展與我們的預期一致。因此，我們重申我們在 2 月 7 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 7 頁。

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

現在我將把電話交給吉姆，讓他詳細介紹我們本季的商業表現。

Well, thank you, Robin, and good afternoon, everyone. I'm pleased to provide an update on our commercial performance for the first quarter, and I'll start with a few comments on HCV.

謝謝你，羅賓，大家下午好。我很高興向大家報告我們第一季的商業業績，首先我想就HCV做一些說明。

Starting with the U.S. Approximately 700,000 people have initiated HCV therapies since the launch of Sovaldi in December 2013, with 90% receiving a sofosbuvir-based regimen. Total U.S. revenue from Gilead's HCV therapies for the quarter was $1.7 billion, down 18% year-over-year and 17% sequentially. The decrease in sequential revenue was driven by the declining sales of Epclusa, resulting in lower inventory, as well as some loss of market share as a result of increased competition.

從美國開始，自 2013 年 12 月 Sovaldi 上市以來，約有 70 萬人開始接受 HCV 治療，其中 90% 的人接受了以索非布韋為基礎的治療方案。吉利德公司本季在美國的丙型肝炎治療藥物總收入為 17 億美元，年減 18%，季減 17%。環比收入下降是由於 Epclusa 銷售下滑導致庫存減少，以及由於競爭加劇導致市場份額下降所致。

For the remainder of 2017, while increased competition will have some level of impact on patient share and pricing, we expect that the continued decline in HCV patient starts will be the primary driver of the year-over-year decrease in revenue. This decline in starts is driven by the evolving profile of patients that are in care. 62% of patients initiating therapy in the first quarter had fibrosis scores of F0 to F2. That's the highest we've seen for this metric and indicative of the fact that patients are coming into care with earlier-stage disease, a trend that is illustrated on Slide 26.

2017 年剩餘時間裡，雖然競爭加劇會對患者份額和定價產生一定程度的影響，但我們預期 HCV 患者數量的持續下降將是收入年減的主要驅動因素。病例數的下降是由接受治療的患者群體特徵的變化所導致的。在第一季開始接受治療的患者中，62% 的纖維化評分在 F0 到 F2 之間。這是該指標我們所見到的最高值，顯示患者在疾病早期階段就接受了治療，這一趨勢在第 26 張幻燈片中有所體現。

Over the last 6 months, we've introduced 2 new direct-to-consumer campaigns. The first launched in late 2016 with the goal of increasing screening among baby boomers. We are pleased to see that this campaign, along with the efforts of organizations like the CDC, had an immediate effect, with a 24% increase in HCV antibody testing among undiagnosed baby boomers over the first 2 months of implementation. The second campaign launched in March and is directed towards diagnosed patients with a goal of encouraging them to seek treatment with Harvoni. We hope these campaigns will continue to have an impact and will help more individuals seek testing, linkage to care and treatment.

在過去 6 個月裡，我們推出了 2 項新的直接面向消費者的行銷活動。第一個計畫於 2016 年底啟動，目標是提高嬰兒潮世代的篩檢率。我們很高興地看到，這項活動以及像美國疾病管制與預防中心這樣的組織的努力，立即產生了效果，在實施的前兩個月內，未確診的嬰兒潮一代的丙型肝炎抗體檢測率增加了 24%。第二項活動於 3 月啟動，旨在鼓勵已確診的患者尋求使用 Harvoni 進行治療。我們希望這些活動能持續產生影響，並幫助更多的人尋求檢測、獲得照護和治療。

It's important to remember that while the time line for a patient to go from entering care to initiating therapy has lengthened and is more variable, there are still nearly 3 million people with HCV infection in the U.S. Only half of them are diagnosed.

值得注意的是，雖然患者從接受護理到開始治療的時間線已經延長且更加不確定，但美國仍有近 300 萬人感染了C型肝炎病毒。其中只有一半人得到了診斷。

Turning to Europe. HCV revenues were down 42% year-over-year and 22% sequentially. Quarterly revenues of $487 million were negatively impacted by lower market share as a result of increased competition. During the quarter, we negotiated new agreements with France and Italy to expand access to HCV patients, regardless of fibrosis score. This means that there are now 14 European countries, including 4 of the 5 major markets, that allow patient access, regardless of disease severity.

轉向歐洲。HCV 營收年減 42%，季減 22%。由於競爭加劇，市佔率下降，季度營收受到負面影響，為 4.87 億美元。本季度，我們與法國和義大利談判達成了新的協議，以擴大 HCV 患者的就醫範圍，無論其纖維化評分如何。這意味著目前有 14 個歐洲國家（包括 5 個主要市場中的 4 個）允許患者獲得醫療服務，無論病情嚴重程度如何。

In addition, Epclusa has now been launched in all 5 of the major markets in Europe, and will be an important treatment option, as some countries have a high percentage of genotype 2 and 3 patients. These patients and their health care providers have been waiting for an effective therapy that does not require coadministration of ribavirin or extended treatment durations.

此外，Epclusa 目前已在歐洲所有 5 個主要市場推出，並將成為重要的治療選擇，因為一些國家有較高比例的 2 型和 3 型基因型患者。這些患者及其醫療保健提供者一直在等待一種無需同時服用利巴韋林或延長治療時間的有效療法。

In Japan, HCV product sales for the first quarter were $205 million, down 81% year-over-year and down 35% sequentially, due to a decrease in patient starts and increased competition. In the Japanese market, nearly 130,000 patients have been treated with a sofosbuvir-based regimen since the launch of Sovaldi in May 2015. Because there remain many untreated patients, we continue to implement our direct-to-consumer education campaign to broaden the awareness of HCV in Japan.

在日本，由於患者數量減少和競爭加劇，第一季丙型肝炎產品銷售額為 2.05 億美元，年減 81%，季減 35%。自 2015 年 5 月 Sovaldi 上市以來，日本市場已有近 13 萬名患者接受了以索非布韋為基礎的治療方案。由於仍有許多患者未接受治療，我們將繼續進行以消費者為導向的教育活動，以提高日本民眾對C型肝炎的認識。

Worldwide, 1.4 million patients have now initiated HCV therapy with a Gilead regimen in less than 4 years. With SOF/VEL/VOX, our investigational pan-genotypic single-tablet regimen for salvage therapy, under regulatory review, we expect to complete our portfolio of HCV therapies later this year.

在過去不到 4 年的時間裡，全球已有 140 萬名患者開始使用吉利德公司的治療方案進行C型肝炎治療。我們正在接受監管審查的用於挽救治療的泛基因型單片療法 SOF/VEL/VOX，預計將於今年稍後完成我們的 HCV 療法產品組合。

Now turning to HIV. We are pleased with the rapid adoption and acceptance of our TAF-based regimens by patients and physicians in the U.S. and Europe. In the U.S., HIV and HBV revenues were $2.3 billion in the first quarter, up 20% year-over-year and down 3% sequentially. As Robin stated earlier, the quarter-on-quarter decline is consistent with the typical seasonality that we see in sub-wholesaler inventory. Importantly, first quarter revenue from our TAF portfolio exceeded $1 billion for the first time, which translates to a quarter-on-quarter growth of 47%.

現在來說說愛滋病。我們很高興看到美國和歐洲的患者和醫生迅速採用和接受我們基於 TAF 的治療方案。在美國，第一季 HIV 和 HBV 的營收為 23 億美元，年增 20%，季減 3%。正如 Robin 之前所說，季度環比下降與我們在二級批發商庫存中看到的典型季節性一致。重要的是，我們 TAF 投資組合的第一季營收首次超過 10 億美元，季增 47%。

The launch of our TAF portfolio continues to drive the year-on-year growth of the Gilead HIV franchise. Genvoya represents nothing less than the most successful launch in U.S. HIV history, as measured by cumulative total prescriptions over the first 5 quarters of launch, following launch. By the end of 2016, Genvoya remained the most prescribed regimen for treatment-naïve patients, accounting for nearly 1 in 3 patients. More broadly, our TAF-based regimens now represent 42% of total Gilead HIV prescription volume just 17 months after the launch of Genvoya and less than a year after the launches of Odefsey and Descovy.

我們推出的 TAF 產品組合持續推動吉利德 HIV 產品線逐年成長。從上市後前五季的累計處方總量來看，Genvoya 堪稱美國 HIV 史上最成功的上市案例。截至 2016 年底，Genvoya 仍是初治患者最常使用的治療方案，約佔患者總數的 1/3。更廣泛地說，在 Genvoya 上市僅 17 個月後，以及 Odefsey 和 Descovy 上市不到一年後，我們基於 TAF 的治療方案已佔吉利德 HIV 處方總量的 42%。

Truvada for PrEP also continues to be an important growth driver for Gilead. We've seen a significant uptick in PrEP usage in 2017, with an estimated 125,000 patients using Truvada as we exited the quarter. This is encouraging, given the important role that PrEP plays in preventing HIV transmission.

Truvada（用於暴露前預防）仍然是吉利德公司重要的成長動力。2017 年 PrEP 的使用量顯著增加，截至本季末，估計有 125,000 名患者正在使用 Truvada。考慮到暴露前預防在預防愛滋病毒傳播方面的重要作用，這令人鼓舞。

Turning to Europe. HIV and HBV revenues were $697 million in the first quarter, down 3% year-over-year and down 1% sequentially. Year-over-year, volume growth, driven by TAF portfolio launches, was offset primarily by FX. Notably, the TAF portfolio revenue grew by 24% quarter-on-quarter.

轉向歐洲。第一季 HIV 和 HBV 收入為 6.97 億美元，年減 3%，季減 1%。受 TAF 產品組合推出的推動，銷售量較去年同期成長，但主要被匯率波動抵銷。值得注意的是，TAF 投資組合收入較上季成長了 24%。

I'm pleased to report that Genvoya launched in France and Italy during the quarter. Genvoya is now available in 23 European countries, including all major markets. In France, the second largest HIV market in the world, Genvoya is off to a particularly strong start. And in early launch markets like Germany, TAF-based regimens already account for up to 60% of Gilead's total HIV prescription volume. This demonstrates the rapid acceptance of TAF by national health systems and the importance of an optimized safety profile for people living longer with HIV.

我很高興地宣布，Genvoya 在本季已在法國和義大利上線。Genvoya 目前已在包括所有主要市場在內的 23 個歐洲國家/地區上市。在世界第二大愛滋病毒感染者市場法國，Genvoya 的開局尤其強勁。在德國等早期上市市場，基於 TAF 的治療方案已佔吉利德 HIV 處方總量的 60%。這表明國家衛生系統迅速接受了 TAF，並且優化安全性對於延長 HIV 感染者壽命至關重要。

The TAF portfolio has achieved preferred status in treatment guidelines in 4 of the 5 major EU markets, as well as the EACS guidelines, with preferred status anticipated in France in the third quarter this year.

TAF 產品組合已在歐盟 5 個主要市場中的 4 個市場以及 EACS 指南中獲得治療指南的優先地位，預計今年第三季將在法國獲得優先地位。

Shifting away from HIV and HCV. Our U.S. cardiovascular team continues to deliver impressive results. Letairis remains the market leader in TAH, with a naïve patient share greater than the top 2 ERA competitors combined, while Ranexa is ranked in the top 5 cardiovascular-branded products in terms of revenue for each of the past 2 years.

逐漸減少對愛滋病毒和C型肝炎的關注。我們的美國心血管團隊持續取得令人矚目的成果。Letairis 仍然是 TAH 市場的領導者，其初治患者份額超過了排名前 2 的 ERA 競爭對手的總和，而 Ranexa 在過去 2 年的收入中一直位列心血管品牌產品前 5 名。

In closing, we were pleased with our first quarter results. For the remainder of the year, we will continue to ensure that as many people as possible can benefit from Gilead products around the world.

總之，我們對第一季的業績感到滿意。在今年剩餘的時間裡，我們將繼續確保世界各地盡可能多的人能夠受益於吉利德的產品。

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

我現在想打電話——把電話轉給約翰。

Thank you, Jim. As you've heard, product revenues for the first quarter of 2017 were down 12% from the fourth quarter of 2016. While any decrease in revenue is disappointing, of course, this decline is a result of the natural challenge of the HCV cure market where, in each country, there was a rapid increase in the number of patients who are treated and cured, followed by a decline in the number of patients seeking care and being able to access HCV treatment.

謝謝你，吉姆。正如你所聽到的，2017 年第一季的產品收入比 2016 年第四季下降了 12%。當然，任何收入的下降都令人失望，但這種下降是丙型肝炎治愈市場自然挑戰的結果，在每個國家，接受治療和治癒的患者人數都迅速增加，隨後尋求治療和能夠獲得丙型肝炎治療的患者人數下降。

The ongoing reduction in patient starts continues to be the major factor impacting our revenues. However, 2017 is progressing as we expected and communicated to you on our last earnings call.

患者數量持續下降仍然是影響我們收入的主要因素。然而，2017 年的進展正如我們預期的那樣，正如我們在上次財報電話會議上向您傳達的那樣。

On a positive note, we continue to see strong uptake of our TAF-based regimens in HIV, pointing to the valuable role these therapies play in the long-term treatment of patients with this disease. Genvoya is now our #1 selling HIV product, surpassing both Truvada and Atripla since the last quarter of 2016.

從積極的方面來看，我們繼續看到基於 TAF 的 HIV 治療方案得到了強有力的推廣，這表明這些療法在 HIV 患者的長期治療中發揮著重要的作用。Genvoya 現在是我們銷量第一的 HIV 產品，自 2016 年最後一個季度以來，銷量超過了 Truvada 和 Atripla。

During the first quarter, I had an opportunity to attend CROI, the Conference on Retroviruses and Opportunistic Infections. This was a good scientific forum with much progress described across the spectrum of HIV research from prevention, to novel targets and treatment, to cure. Gilead's work featured prominently in the conference, including Phase II data for bictegravir used in combinations with F/TAF, long-term data supporting use of Genvoya, and preclinical data describing the potential of our novel capsid inhibitor as a long-acting treatment.

第一季度，我有機會參加了逆轉錄病毒和機會性感染會議（CROI）。這是一個很好的科學論壇，介紹了愛滋病研究在預防、新標靶和治療、治癒等方面取得的許多進展。吉利德公司在會議上重點介紹了其研究成果，包括比克替拉韋與 F/TAF 聯合使用的 II 期數據、支持 Genvoya 使用的長期數據，以及描述我們新型衣殼抑制劑作為長效治療藥物潛力的臨床前數據。

During CROI, there was great enthusiasm for the emerging profile of B/F/TAF, as this is the first time we're able to present the full 48-week data set from our Phase II study.

在 CROI 期間，人們對 B/F/TAF 的新興特性表現出極大的熱情，因為這是我們首次能夠展示來自 II 期研究的完整 48 週資料集。

As many of you know, we initiated Phase III studies last year based on our interim look at the 24-week data from this study. These 4 Phase III studies include more than 2,400 patients, and enrollment was completed in the third quarter of last year. We look forward to sharing data from these studies in the coming months and anticipate that we will begin submitting regulatory filings for approval in the third quarter of this year.

正如你們許多人所知，我們去年根據對研究 24 週數據的初步分析，啟動了 III 期研究。這 4 項 III 期研究包括 2,400 多名患者，入組工作已於去年第三季完成。我們期待在未來幾個月分享這些研究的數據，並預計今年第三季開始提交監管審批文件。

The progress we made in providing new options to patients with HIV is remarkable, and I'm proud of Gilead's contributions over our 30-year history.

我們在為 HIV 患者提供新的治療選擇方面取得的進展是顯著的，我為吉利德 30 年發展歷程中所做出的貢獻感到自豪。

Last month, Gilead research was featured in 85 abstracts at the International Liver Conference, or EASL, as it's often called. One of the most exciting stories emerging from the conference involved NASH, or nonalcoholic steatohepatitis. This is a disease that garnered relatively little attention at medical meetings a few years ago but is increasingly understood as a serious health issue for patients, particularly those presenting with the later stages of fibrosis. These are the patients facing the greatest risk of complications and those with the most urgent need for new treatment options.

上個月，吉利德的研究成果在國際肝臟大會（EASL）上以 85 篇摘要的形式發表。會議期間湧現的最激動人心的故事之一與 NASH（非酒精性脂肪性肝炎）有關。幾年前，這種疾病在醫學會議上並未引起太多關注，但人們越來越認識到，它對患者來說是一個嚴重的健康問題，尤其是對那些處於纖維化晚期的患者而言。這些患者面臨最大的併發症風險，也最迫切需要新的治療方案。

We shared proof-of-concept data for GS-0976, our inhibitor of Acetyl-CoA carboxylase, or ACC, in an oral late-breaker presentation. ACC catalyzes the rate-limiting step in de novo lipogenesis, which means the formation of new fat. Inhibition of ACC with GS-0976 leads to significant reductions in both liver fat content and stiffness, with decreases in markers of liver fibrosis seen after 12 weeks of treatment. We have now progressed GS-0976 to a larger Phase II study.

我們在口頭最新研究成果報告中分享了我們的乙醯輔酶A羧化酶（ACC）抑制劑GS-0976的概念驗證數據。ACC 催化從頭脂肪生成（即新脂肪的形成）的速率限制步驟。使用 GS-0976 抑制 ACC 可顯著降低肝臟脂肪含量和硬度，治療 12 週後可觀察到肝纖維化標記的減少。我們現在已經將 GS-0976 推進到更大規模的 II 期研究階段。

In addition to 0976, another compound in development is our ASK-1 inhibitor, selonsertib. We described for you previously the exciting data presented at ASLD last fall showing that inhibition of ASK-1 selonsertib led to decreases in fibrosis and secondary markers of NASH in a dose-dependent manner. We now have 2 Phase III trials underway, evaluating selonsertib in NASH patients with bridging fibrosis and cirrhosis.

除了 0976 之外，我們正在研發的另一種化合物是 ASK-1 抑制劑 selonsertib。我們先前已向您介紹過去年秋季在 ASLD 會議上公佈的令人興奮的數據，該數據顯示，ASK-1 抑制劑 selonsertib 可劑量依賴性地降低纖維化和 NASH 的次要標誌物。我們目前正在進行 2 項 III 期試驗，評估 selonsertib 對伴有橋接纖維化和肝硬化的 NASH 患者的療效。

Also, at NASH, GS-9674, a gut-restricted FXR agonist, has progressed into Phase II studies having shown biological activity through up regulation of FGF19 in a Phase I study. Complete resolution of a NASH may require the inhibition of more than one pathway, and animal studies indicate that combinations of selonsertib, GS-0976 or GS-9674 may be more effective than the individual components alone. We have initiated a Phase II study in 20 patients evaluating the combination of selonsertib and GS-9674, and we'll initiate additional combination studies this year. If these combinations prove safe and efficacious, we will move 1 or more into extended Phase II evaluation next year.

此外，在 NASH 中，腸道限制性 FXR 激動劑 GS-9674 已進入 II 期研究，該藥物在 I 期研究中透過上調 FGF19 顯示出生物活性。徹底解決 NASH 可能需要抑制多個通路，動物研究表明，selonsertib、GS-0976 或 GS​​M-9674 的組合可能比單獨使用其中的成分更有效。我們已啟動一項針對 20 名患者的 II 期研究，評估 selonsertib 和 GS-9674 的聯合用藥，今年我們將啟動其他聯合用藥研究。如果這些組合被證明是安全有效的，我們將在明年將其中一種或多種組合推進到擴展的 II 期評估階段。

In HCV, we had 6 presentations at EASL further characterizing the efficacy and safety of SOF/VEL/VOX, our pan-genotypic single-tablet regimen in more than 1,000 DAA-naïve and DAA-experienced patients across all HCV genotypes. Most notable is data showing no impact of resistance-associated substitutions on the high efficacy of SOF/VEL/VOX for 12 weeks in DAA-experienced patients. As Jim mentioned, this regime is currently under regulatory review with a U.S. PDUFA -- FDA PDUFA date of August 8.

在 HCV 方面，我們在 EASL 上進行了 6 次報告，進一步描述了 SOF/VEL/VOX 的療效和安全性，這是我們針對所有 HCV 基因型的 1000 多名 DAA 初治和 DAA 治療過的患者開發的泛基因型單片療法。最值得注意的是，數據顯示，在接受 DAA 治療的患者中，SOF/VEL/VOX 治療 12 週後，抗藥性相關的替換對 SOF/VEL/VOX 的高效性沒有影響。正如吉姆所提到的，該方案目前正在接受監管審查，美國藥品用戶付費法案 (PDUFA) 的批准日期為 8 月 8 日。

Also, in HCV, data from 2 Phase II studies of Harvoni demonstrated HCV cure rates of 99% in children aged 6 to 11, and 100% in adults co-infected with HCV and HBV. The pediatric data have recently been included in our U.S. label.

此外，在 HCV 方面，Harvoni 的 2 項 II 期研究數據顯示，6 至 11 歲兒童的 HCV 治癒率為​​ 99%，同時感染 HCV 和 HBV 的成年人的 HCV 治癒率為​​ 100%。兒科數據最近已納入我們的美國標籤中。

And finally, we presented 96-week results from 2 ongoing Phase III studies evaluating the safety and efficacy of daily Vemlidy in HBeAG-positive and negative patients, and 24-week data in patients switching from Viread to Vemlidy. The results reinforce Vemlidy as an important treatment option for patients living with chronic hepatitis B infection.

最後，我們發表了 2 項正在進行的 III 期研究的 96 週結果，這兩項研究評估了每日服用 Vemlidy 對 HBeAG 陽性和陰性患者的安全性和有效性，以及從 Viread 轉用 Vemlidy 的患者的 24 週數據。研究結果進一步證實了Vemlidy是治療慢性B型肝炎感染患者的重要選擇。

In the area of inflammation, Phase III studies of filgotinib, a JAK-1 selective inhibitor, are underway and enrolling in rheumatoid arthritis, ulcerative colitis and Crohn's disease. This once-daily dosing and approximately 1,700 patient years of experience, we and our partner, Galapagos, have now started or announced the intention to start 6 additional Phase II studies across a range of different inflammatory diseases for JAK-1 activities implicated.

在發炎領域，JAK-1 選擇性抑制劑 filgotinib 的 III 期研究正在進行中，並招募類風濕性關節炎、潰瘍性結腸炎和克隆氏症患者。憑藉每日一次的給藥方案和約 1700 患者年的經驗，我們和我們的伴侶 Galapagos 現在已經開始或宣布計劃開始 6 項額外的 II 期研究，以研究 JAK-1 活性在多種不同發炎性疾病中的作用。

Before we wrap up our prepared remarks, I want to mention another recent and important event at Gilead -- which Gilead's work was highlighted, and that's in Neglected Tropical Disease Summit that took last -- place last month in Geneva. At this meeting, which brought together the industry, the World Health Organization, public health and government officials and many NGOs working to deliver medicines in the developing world, we reaffirmed our commitment to the London declaration on neglected tropical diseases. This declaration, signed 5 years ago, outlined the WHO's ongoing efforts to control, eliminate or eradicate 10 key neglected tropical diseases.

在我們結束準備好的發言之前，我想提一下吉利德最近發生的一件重要事件——吉利德的工作在這次事件中得到了重點展示，那就是上個月在日內瓦舉行的被忽視的熱帶病峰會。在這次會議上，業界人士、世界衛生組織、公共衛生和政府官員以及許多致力於向發展中國家提供藥品的非政府組織齊聚一堂，我們重申了對《倫敦被忽視的熱帶疾病宣言》的承諾。這份 5 年前簽署的宣言概述了世界衛生組織為控制、消除或根除 10 種主要被忽視的熱帶疾病而正在進行的努力。

In Gilead's case, and related to this declaration, we have partnered with WHO for many years to provide AmBisome for use in several developing countries as a treatment for visceral leishmaniasis, a deadly parasitic infection. This is a very important application for AmBisome, which is better known for use in cases of systemic fungal infections. We are pleased that the use of AmBisome, along with other mitigation strategies, has resulted in a marked decrease in the number of visceral leishmaniasis cases in India, Nepal and Bangladesh.

就吉利德而言，與此聲明相關的是，我們多年來一直與世界衛生組織合作，向幾個發展中國家提供兩性黴素B脂質體，用於治療內臟利甚曼病，這是一種致命的寄生蟲感染。對於AmBisome而言，這是一個非常重要的應用，AmBisome更廣為人知的用途是治療全身性真菌感染。我們很高興看到，AmBisome 與其他緩解策略的結合使用，已顯著減少了印度、尼泊爾和孟加拉國的內臟利甚曼病病例數。

In addition to this visceral leishmaniasis, we have research ongoing to address other neglected or emerging tropical diseases that pose significant public health threats in resource-limited parts of the world, for example, our work on GS-5734 for the treatment of Ebola and potentially other deadly viruses such as those that cause SARS and MERS.

除了內臟利甚曼病之外，我們還在進行研究，以應對其他被忽視或新出現的熱帶疾病，這些疾病在世界資源匱乏地區構成重大的公共衛生威脅，例如，我們正在研究 GS-5734，用於治療伊波拉病毒以及其他潛在的致命病毒，如引起 SARS 和 MERS 的病毒。

In 30 years, we've learned that the value of partnerships in developing innovative new therapies and have demonstrated a willingness to make bold moves. That hasn't changed, and we're committed to building on our success in HIV and HCV by leveraging our own scientific expertise as well as the knowledge of others through collaborations and partnerships to work towards the next generation of life-saving therapies.

30年來，我們意識到合作在開發創新療法方面的價值，並展現出勇於採取大膽措施的意願。這一點沒有改變，我們致力於鞏固我們在 HIV 和 HCV 領域取得的成功，透過合作與夥伴關係，利用我們自身的科學專長以及其他人的知識，努力研發下一代拯救生命的療法。

I'd like to conclude by thanking you for your interest in Gilead and thanking our nearly 9,000 employees for the hard work that is well-represented in our results this quarter.

最後，我要感謝各位對吉利德的關注，並感謝我們近9,000名員工的辛勤工作，他們的努力在本季度的業績中得到了充分體現。

So let's now open the call for questions. Operator?

現在開始接受提問。操作員？

(Operator Instructions) And our first question comes from Geoff Porges of Leerink Partners.

（操作說明）我們的第一個問題來自 Leerink Partners 的 Geoff Porges。

I appreciate all the color on the dynamics in HCV and HIV. Perhaps we could talk a little bit about the HIV category. And, Jim or John, give us a sense of what percentage of your HIV revenue in the U.S. today is Medicaid-funded. And then, what percentage is covered, or at least patients, are covered by insurance provided by ADAPs? And then, lastly, what do you expect to happen to pricing as you get into generic Viread being available, both outside the U.S. and then in the U.S. at the end of the year? Should we anticipate Atripla's price coming down to some of the components or staying at the branded price? Sorry, but they're sort of related.

我非常欣賞你對C型肝炎和愛滋病動態的生動描述。或許我們可以稍微談談愛滋病毒感染者這個族群。吉姆或約翰，請告訴我們，目前你們在美國的愛滋病防治收入中，有多少百分比是由醫療補助計劃（Medicaid）資助的。那麼，ADAP提供的保險涵蓋了多少比例的患者，或至少有多少比例的患者獲得了保險保障？最後，隨著通用版Viread在美國以外地區上市，以及年底在美國上市，您預期價格會發生什麼變化？我們應該預期 Atripla 的價格會下降到部分成分的價格水平，還是會保持品牌價格？抱歉，但它們之間確實有點關聯。

Geoff, it's Kevin here. Let me have a go at the first couple of parts, and then, Jim can also help out. So I'll just link the business really between the public side and the private side for HIV, and we got about 55% of our business HIV sales go through the public, and about 45% go through the private. It's actually almost a direct reverse of HCV. And of that 55%, 20% or so is ADAP in the U.S. So that's basically the situation that we have. We're very pleased with the progress with Genvoya. As we said on the last earnings call, we will see the effects of generics in Europe in the second half of this year. That will be a country-by-country event. I think, the most direct effect, of course, will be on Viread and Truvada. The most important part, as far as we're concerned, is to make sure, as many of our countries convert from TDF-based regimens to TAF-based regimens. And as you heard from Jim, some of our European markets are doing very, very well on that front. We've got Germany already at a ratio of 60% TAF to TDF. So we're trying to control, I think, the most important variable, which is good for patients, which is to see them converted to TAF away from TDF in advance of the change in the TDF landscape.

傑夫，我是凱文。讓我先嘗試前幾個部分，然後吉姆也可以幫忙。所以，我只想把愛滋病防治業務的公共部門和私部門連結起來，我們愛滋病防治業務的銷售額中約有 55% 來自公部門，約有 45% 來自私部門。實際上，它幾乎是丙型肝炎的直接逆轉。其中 55% 左右，美國 ADAP 約佔 20%。這就是我們目前面臨的基本情況。我們對 Genvoya 的進展非常滿意。正如我們在上次財報電話會議上所說，我們將在今年下半年看到仿製藥在歐洲的影響。這將是一項逐國進行的行動。我認為，最直接的影響當然會反映在 Viread 和 Truvada 上。就我們而言，最重要的部分是確保我們許多國家從基於 TDF 的治療方案過渡到基於 TAF 的治療方案。正如吉姆所說，我們的一些歐洲市場在這方面表現得非常非常好。德國目前的TAF與TDF比例已達60%。所以，我認為，我們正在努力控制最重要的變量，這對患者來說是好事，那就是在 TDF 市場格局發生變化之前，讓他們從 TDF 轉為 TAF。

And, Kevin, just to add on that, and I agree with everything you said, I think HIV is a bit of a different market over the years. Of all the markets, of all the chronic therapy markets Gilead's ever been in, it's been driven more by increases in patient volume than by changes in price. And that's -- there's always some element of both in every therapeutic area that you're in. But disproportionately, in HIV, there's always been a healthy, steady flow of number of treated patients each year. As I think you're probably aware, and as Kevin just said, we're already in heavily, deeply discounted payer segments in the U.S. market. What that means is that's already part of the run rate. So the normal impact of a generic is a big change from where you are. We're already -- especially for the older products that are going to be coming off patent, the difference between generic pricing and where those prices are right now is much more incremental than you'd see in most markets. And anyways, that's something that's just very unique with that. We continue to see, obviously, a strong support for single-tablet regimens and fixed-dose combinations. And, of course, there will be some level of impact whenever there's generic entry, particularly outside of the U.S. But we still very firmly believe that when we want -- ultimately have the full launch of our entire TAF portfolio, particularly BIC/TAF, B/F/TAF, this remains very much a sustainable franchise going forward. Again, I would say, we hear sometimes how sustainable is price levels in HIV, that really hasn't been the story of HIV. It's really -- I mean, particularly in the U.S. market, because of the deeply discounted segments and the CPI-U penalties you have over time, this has been a market that has overwhelmingly been driven by patient volumes. So we're not as reliant on that. We have not been historically as reliant on -- if you look at list pricing, for sure, there is -- it's there, but net pricing has deteriorated over time, and that's already in the run rate. But I'll stop there. And we feel very confident in this being a sustainable franchise.

凱文，我還要補充一點，我完全同意你的觀點，我認為這些年來愛滋病市場發生了一些變化。在吉利德涉足的所有市場，所有慢性病治療市場中，患者數量的成長比價格的變化更能推動吉利德的發展。也就是說，在你所處的任何治療領域中，總是存在著這兩種因素的某種成分。但與愛滋病毒感染者相比，每年接受治療的患者人數一直保持著健康、穩定的成長。我想你可能已經意識到了，正如凱文剛才所說，我們在美國市場已經進入了折扣力度很大的付費用戶領域。這意味著這已經是運行率的一部分了。所以，仿製藥通常會帶來很大的改變。我們已經看到——特別是對於即將失去專利保護的老產品而言，仿製藥的價格與這些產品目前的價格之間的差異，比你在大多數市場上看到的要大得多。總之，這是它非常獨特的地方。顯然，我們繼續看到人們對單片製劑和固定劑量組合的強烈支持。當然，每當有仿製藥進入市場，尤其是在美國以外的地區，都會產生一定程度的影響。但我們仍然堅信，當我們最終全面推出我們的整個 TAF 產品組合，特別是 BIC/TAF、B/F/TAF 時，這仍然是一個非常可持續的特許經營權。我再次強調，我們有時會聽到關於愛滋病毒價格水平可持續性的說法，但這實際上並不是愛滋病毒的真實情況。確實如此——我的意思是，尤其是在美國市場，由於折扣力度很大的細分市場以及隨著時間的推移 CPI-U 的懲罰，這個市場在很大程度上是由患者數量驅動的。所以我們並不那麼依賴它。從歷史上看，我們並沒有那麼依賴——如果你看一下標價，當然，標價是有的——它確實存在，但淨價隨著時間的推移而惡化，而且這已經體現在運行率中了。但我就說到這裡吧。我們非常有信心，這將是一個可持續發展的特許經營模式。

Geoff, just 2 last points, Geoff. We obviously thought about these events as part of our guidance, they're included in our guidance. And the other point I'd like to make is, I think for the first time, we've really seen a downturn in the number of Atripla patients. Atripla stayed very strong for 10 years since its launch. But with Genvoya now and the TAF-based regimens, we've really seen that turn. And I think that's good for patients, and obviously, it's very encouraging for Gilead.

傑夫，只剩最後兩分了，傑夫。我們顯然在製定指導方針時考慮到了這些事件，它們都包含在我們的指導方針中。我想提出的另一點是，我認為我們第一次真正看到了 Atripla 患者數量的下降。Atripla 自推出以來，10 年間一直保持著強勁的成長動能。但現在有了 Genvoya 和基於 TAF 的療法，我們已經真正看到了這種轉變。我認為這對患者來說是好事，而且顯然對吉利德公司來說也是非常令人鼓舞的。

And our next question comes from Geoff Meacham of Barclays.

下一個問題來自巴克萊銀行的傑夫·米查姆。

Jim, on HIV, PrEP has been a big volume driver. What's the typical duration of use? And how would you size the opportunity? And then, John, you mentioned revenue trends in the quarter. Just curious if there's a metric, be it cash flow or margins, that -- maybe that best informs your biz dev or deal strategy?

吉姆，關於愛滋病毒，PrEP（暴露前預防）一直是推動銷售成長的重要因素。通常使用時長是多久？你如何評估這個機會？約翰，你剛才提到了本季的收入趨勢。我只是好奇，有沒有什麼指標，像是現金流或利潤率，能夠最好地指導你的業務拓展或交易策略？

Sure. So starting with PrEP, what we're seeing, very encouragingly and I think consistent with CDC guidance and data, is that we're starting to see persistency that is very similar to patients taking anti-retroviral therapy for treatment, and that's what you want. Frankly, 3, 4 years ago, PrEP prescribing was very episodic, and we're not seeing that now. So that's not just a good thing for Gilead, I think that's a good thing for patients. That's what the data would say is the way that PrEP should be prescribed. So we're not seeing very much shade of light between those 2. So -- and because of that, we do see this as a significant continued driver of growth. I think as we said in the last earnings call, 90% of PrEP prescribing was coming out of 5 cities coming into this year. And they weren't the cities where a lot of the epidemic is really starting to, unfortunately, increase, areas like New Orleans, D.C., Newark, Oakland, the Bronx. And part of our efforts, both with the field-based team that we deployed of prevention specialists and also with some of our education that we're doing, is geared towards those markets because, honestly, I think that's where the needle can be moved the most.

當然。因此，從 PrEP 開始，我們看到的情況非常令人鼓舞，而且我認為這與 CDC 的指導和數據一致，那就是我們開始看到 PrEP 的持續性與接受抗逆轉錄病毒療法治療的患者非常相似，而這正是我們所希望的。坦白說，3、4年前，PrEP的處方開立非常零散，而現在這種情況已經不存在了。所以我認為這不僅對吉利德公司來說是件好事，對病人來說也是好事。數據顯示，這就是 PrEP 應該服用的方式。因此，我們看不到這兩者之間有太大的差異。正因如此，我們認為這將是持續成長的重要驅動力。我認為正如我們在上次財報電話會議上所說，今年 90% 的 PrEP 處方都來自 5 個城市。而且不幸的是，這些城市並不是疫情真正開始蔓延的地區，例如紐奧良、華盛頓特區、紐瓦克、奧克蘭、布朗克斯等地。我們所做的努力，包括我們部署的預防專家實地團隊以及我們正在進行的一些教育活動，都是針對這些市場的，因為老實說，我認為這才是最有可能取得進展的地方。

So Geoff, I'll give you a shorter answer to your question. But you asked about metrics. Certainly, as we think about opportunities, we do look for things which have potential to have a high operating margin. That's important to us. And, of course, informs the potential cash flow from the business in the future. We also first look for things that have scientific and medical needs, such that we can build a sustainable business that would have the top line growth that we desire, along with those up margins and cash flows. So those things are all informative in terms of how we think about it.

傑夫，我來簡短地回答你的問題。但你問的是指標。當然，在考慮機會時，我們會尋找那些有潛力獲得高營業利益率的項目。這對我們來說很重要。當然，這也有助於預測企業未來的潛在現金流。我們首先尋找具有科學和醫療需求的產品，這樣我們才能建立一個可持續發展的業務，實現我們所期望的營收成長，以及利潤率和現金流的成長。所以，這些都對我們思考這個問題很有幫助。

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。

I wanted to ask about bictegravir specifically. And maybe you could just talk about how do you view the potential to being able to achieve superiority with bictegravir over dolutegravir? And maybe as part of your answer, if you're willing, can you talk about what's the statistical plan and the powering in the head-to-head naïve study?

我想具體諮詢比克替拉韋的情況。或許您可以談談您如何看待比克替拉韋相對於多替拉韋的療效優勢潛力？或許作為您回答的一部分，如果您願意的話，能否談談這項直接比較的初步研究的統計方案和統計功效？

Matt, I'm happy to answer that. So the head-to-head studies in naïve patients, remember, one of them is comparing bictegravir to dolutegravir, the other one is comparing our single-tablet regimen to [tri-immune]. Both assume that the comparator arm as a 91% success rate and the lower bound of the 95% confidence interval is 12%. So the delta is 12%. Now what the chances of achieving superiority, there is always a possibility. I don't think I would like to speculate on that. It really depends. This would clearly show that these are both large studies and would clearly show if there's a difference between these 2 drugs, we should see it.

馬特，我很樂意回答這個問題。所以，對於初治患者進行的頭對頭研究，請記住，其中一項是將比克替拉韋與多替拉韋進行比較，另一項是將我們的單片療法與[三聯免疫]進行比較。兩者都假設比較組的成功率為 91%，95% 信賴區間的下限為 12%。所以差值為 12%。至於取得優勢的幾率有多大，總是有可能性的。我不想對此妄加猜測。這真的要看情況。這將清楚地表明這兩項研究的規模都很大，並且能夠清楚地表明，如果這兩種藥物之間存在差異，我們應該能夠看到這種差異。

Yes, Matt, the only other thing I would add from a kind of commercial point of view is that the success of Genvoya, the success of Descovy is the platform for BIC/F/TAF. So we see it as a family. TAF is doing extraordinarily well. You saw the results of Descovy in the quarter. So that's just the building block upon which that we'll launch BIC/F/TAF. So the momentum we really have going now will be taken forward with B/F/TAF. But we see it all as sort of a collective platform.

是的，Matt，從商業角度來看，我唯一要補充的是，Genvoya 的成功、Descovy 的成功是 BIC/F/TAF 的平台。所以我們把它看作一個家庭。TAF表現非常優異。你已經看到了 Descovy 在本季的表現。所以這只是我們啟動 BIC/F/TAF 的基礎模組。因此，我們現在取得的進展勢頭將由 B/F/TAF 繼續推進。但我們將其視為一個集體平台。

Matt, I forgot to add something. Of course, we will look for superiority, so the primary test would be non-inferiority. And if we meet that, we will, of course, look for superiority, which is, of course, a possibility.

馬特，我忘了補充一點。當然，我們會尋求優越性，因此首要檢驗標準是非劣效性。如果我們達到了那個目標，我們當然會尋求優勢，這當然是有可能的。

And our next question comes from Josh Schimmer of Piper Jaffray.

下一個問題來自 Piper Jaffray 公司的 Josh Schimmer。

Maybe you can discuss why TAF is so strong in Germany versus U.S. And then, as you think about launching bictegravir into these markets, is that something that's going to sustain the current trajectory of TAF adoption? Or do you expect it to accelerate the penetration? And if it's accelerating, what are the patient populations that, that one will specifically unlock?

或許您可以探討為什麼 TAF 在德國比在美國更受歡迎。然後，當您考慮將比克替拉韋引入這些市場時，這是否會維持 TAF 目前的發展勢頭？還是你認為它會加速滲透？如果這種趨勢正在加速發展，那麼個人哪些患者群體將從中受益？

You said TAF update in Germany versus the U.S.

您提到德國與美國相比的TAF更新。

Yes. Sorry, Josh, you broke up a little bit, so we're going to try to recreate your question as best we can. We'll turn it over to Jim for that.

是的。抱歉，Josh，你剛才說的有點語無倫次，所以我們會盡力把你的問題重新表述一遍。這件事就交給吉姆處理吧。

Yes. So my apologies that I didn't hear all that. I think I have it now. But I think what we have seen in Germany is consistent with what we've seen in other early launch markets in Europe, which is, number one, rapid adoption -- or rapid acceptance of the TAF profile and treatment guidelines. Again, we have it in 4 of the 5 markets right now, in addition to EACS. But also, a strong desire to, appropriately, depending on the label, move patients to the TAF-based regimens. And because Genvoya launched earlier there, that's a good example of what we're seeing in some of our earlier markets. The example we gave with Germany was up to 60%. We also have some earlier launch markets in the Nordics and some of the Northern European countries that tend to launch earlier that are there or thereabouts, closer to 60%. So the encouraging thing for us, too, is that as we mentioned, we just launched Genvoya in France this quarter and in Italy literally at the end of the quarter. So we've got a lot of room to grow there and try to get up to the levels that we've seen in the other countries. But it's -- I think it's primarily a function of just it was an earlier launch. People are seeing good results. They realize that this is a patient population that is aging. And the attributes of TAF in a 50- to 60-year-old patient are even more important than they are in a 40-year-old patient. And I think we're seeing that reflected.

是的。很抱歉我沒聽到所有這些。我想我現在明白了。但我認為我們在德國看到的情況與我們在歐洲其他早期上市市場看到的情況一致，那就是，第一，TAF 概況和治療指南的快速採用或快速接受。目前，除了 EACS 之外，我們在 5 個市場中的 4 個市場都有這項服務。但同時也強烈希望根據標籤情況，適當地將患者轉移到基於 TAF 的治療方案中。由於 Genvoya 更早在那裡推出，這很好地說明了我們在一些早期市場看到的情況。我們舉的德國的例子是高達 60%。我們在北歐和一些北歐國家也有一些較早的上市市場，這些國家往往更早推出產品，它們的上市率接近或超過 60%。所以，對我們來說，令人鼓舞的是，正如我們所提到的，我們本季剛剛在法國推出了 Genvoya，並在本季末在義大利推出了 Genvoya。因此，我們在這方面還有很大的發展空間，並努力達到我們在其他國家看到的水平。但我認為這主要是因為它的發佈時間更早。人們看到了良好的效果。他們意識到這是一個正在老化的患者群體。對於 50 至 60 歲的患者而言，TAF 的特徵比對於 40 歲的患者更為重要。我認為我們已經看到了這種現象。

Josh, it's Kevin. I was just out in Australia about 10 days ago. They've already got a 40% conversion to TAF. So it's happening around the world, where we've launched in most markets, a lot of markets just over a year. I would also say that with HIV, as Jim referred to earlier there, this is not a contracting type of market. This is once you have reimbursement, then generally, physicians have the freedom to operate and will follow guidelines and put patients on advances in therapy. And clearly, TAF is an advancement on TDF.

喬希，我是凱文。我大約十天前剛去過澳洲。他們已經實現了 40% 的用戶向 TAF 轉換。所以這種情況正在世界各地發生，我們在大多數市場都推出了服務，很多市場也只花了一年多一點的時間就推出了服務。我還要補充一點，就像吉姆之前提到的那樣，愛滋病毒感染者並不屬於市場萎縮的範疇。一旦獲得報銷，醫生通常就有了自主操作的自由，他們會遵循指導方針，讓患者接受更先進的治療。顯然，TAF 是 TDF 的升級版。

I think the one final thing I'd say is there's -- in some quarters, there's some worry that as you get into some of the generic options, that choice will be taken out of physician's hands. So you do see a lot of physicians wanting to switch to TAF while they have the ability to do that, and that makes a lot of sense.

最後我想說的是，在某些方面，人們擔心隨著一些通用藥物的出現，醫生將無法再掌控選擇權。所以你會看到很多醫生都想在有能力的時候改用TAF，這很有道理。

Got it. And the bictegravir impact?

知道了。比克替拉韋的影響呢？

I'm sorry, Josh. We couldn't hear that.

對不起，喬希。我們聽不見。

So I said the impact of bictegravir on the adoption curve accelerate or just remain...

所以我說，比克替拉韋對市場接受度曲線的影響會加速還是保持不變…

Do you think bictegravir is going to accelerate the adoption curve of TAF.

你認為比克替拉韋會加速TAF的普及嗎？

I do. Yes. I mean, I've said it, and Norbert's probably -- we've all said it in this room. I truly believe that it is the first single-tablet regimen we've had without trade-offs. And I believe that most of our physicians see it that way, too. And I'm looking at my clinical colleagues in the room here, and that's what we hear from our advisors.

我願意。是的。我的意思是，我已經說過，諾伯特可能也說過──我們在這個房間裡的所有人都說過。我真心相信這是我們迄今為止推出的第一個無需任何妥協的單片療程。我相信我們大多數醫生也都是這麼認為的。我看著在座的各位臨床同事，這正是我們的顧問告訴我們的。

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

下一個問題來自瑞士信貸的 Alethia Young。

I guess I'll continue the trend of no hep C questions, but thinking about NASH. In one of your slides, you said less than 1% of patients were diagnosed. So I'm just curious, kind of what you're doing alongside your Phase II, Phase III work to kind of drive diagnosis, like particular biomarker work or anything to that respect?

我想我會繼續不問C肝方面的問題，但會考慮非酒精性脂肪性肝炎（NASH）。你在一張投影片中提到，只有不到 1% 的患者得到了診斷。所以我很好奇，除了第二期、第三期臨床試驗之外，你們還在做哪些工作來推動診斷，例如特定的生物標記研究或其他相關方面的工作？

So Alethia, I want to answer first, then if, Kevin, or -- if you have any comments. So we are including in our Phase III studies, of course, the primary endpoint, as you know, is histology. We think that's a potential hurdle to diagnose patients and get patients into care. So we're looking at the use of FibroScan with all patients in that study. And hopefully, we can then show the correlation between FibroScan and histology that, that may be a way to include those data in the label. Again, we have not discussed this with regulatory authorities. It's too early for that. We just have to see what the data looks like. But clearly, one thing from a clinical point of view is to get away from doing biopsy. And we're also looking at the usual markers of fibrosis. We presented at EASL the ELF data and others, like CK-18. So these are all serum markers that have to do with fibrosis, and we showed a fairly good correlation between these serum markers and MRE, so magnetic resonance elastography. And if we can do that same thing showing the correlation with histology, then hopefully, this will become the accepted diagnostic avenue.

所以，Alethia，我想先回答你，然後Kevin，或者——如果你有任何意見的話。因此，如您所知，我們的 III 期研究當然包括了主要終點，即組織學。我們認為這可能是診斷病人並讓病人接受治療的潛在障礙。所以我們正在研究研究中所有患者使用 FibroScan 的情況。希望我們能夠證明 FibroScan 與組織學之間的相關性，這或許是一種將這些資料納入標籤的方法。我們尚未就此事與監管機構進行討論。現在談這個還為時過早。我們只需要看看數據是什麼樣的。但很顯然，從臨床角度來看，應該避免進行切片檢查。我們也在觀察纖維化的常見標記。我們在 EASL 上展示了 ELF 數據和其他數據，例如 CK-18。所以這些都是與纖維化有關的血清標記物，我們發現這些血清標記與磁振造影彈性成像（MRE）之間有相當好的相關性。如果我們能夠證明這種方法與組織學結果的相關性，那麼希望這能成為公認的診斷途徑。

Yes, Alethia, not much to add. Yes, we've got to find noninvasive measures, but I would emphasize that we like the focus of going into the F3 and F4 patient. I mean, they're very defined. Somebody who's got cirrhosis, it's a very defined patient population. And I think with -- perhaps different from perhaps some other companies in the area, we like that focus, and that's where we want to begin our entry into NASH and then build upon that.

是的，阿萊西亞，沒什麼要補充的了。是的，我們必須找到非侵入性措施，但我強調，我們更傾向於關注 F3 和 F4 患者。我的意思是，它們的界線非常清晰。患有肝硬化的人，這是一個非常明確的患者群體。我認為，或許與該領域的其他一些公司不同，我們喜歡這種專注，這也是我們希望進入 NASH 領域並在此基礎上發展壯大的起點。

Alethia, I want to add, we had another presentation at EASL about the study of simtuzumab in bridging fibrosis and cirrhosis, that overall field. So it didn't show any efficacy. But it taught us a lot about disease progression endpoints. And it is clear that fibrosis is the only predictive biomarker, the only predictive diagnostic that predicts clinical outcomes. And we also got a good sense for what we can experience over a year or 2 years in terms of clinical events. And based on these data, we are comfortable that with 2-year follow-up, we should have enough clinical events, hepatic decompensation, ascites, et cetera, that would get us potentially full approval, rather than accelerated approval based on histology.

Alethia，我想補充一點，我們在 EASL 上還做了另一次關於 simtuzumab 在橋接纖維化和肝硬化方面的研究的報告，這是該領域的一個整體。所以它並沒有顯示出任何療效。但這讓我們對疾病進展終點有了許多了解。很明顯，纖維化是唯一的預測性生物標記物，也是唯一能夠預測臨床結果的預測性診斷指標。我們也對未來一兩年內可能出現的臨床事件有了比較清楚的認知。根據這些數據，我們有信心，經過 2 年的隨訪，我們應該能夠獲得足夠的臨床事件、肝功能失代償、腹水等，從而有可能獲得完全批准，而不是基於組織學的加速批准。

And our next question comes from Cory Kasimov of JP Morgan.

下一個問題來自摩根大通的科里·卡西莫夫。

I wanted to ask about business development. And curious how much of a barrier all the uncertainty in Washington right now regarding tax reform is when it comes to pulling the trigger on potential BD opportunities. And then, following some of the recent hires you've made over the last 6 or so months, do you think you have the bandwidth now to more fully explore the myriad of assets in companies that are out there?

我想諮詢一下業務拓展方面的問題。我很好奇，目前華盛頓在稅制改革方面存在的所有不確定性，會對抓住潛在的商業發展機會構成多大的阻礙。那麼，在最近六個月左右的時間裡，您進行了一些招聘之後，您認為您現在是否有精力更充分地探索市場上各種公司的眾多資產？

Thanks for the question, Cory. So first of all, with regard to Washington, I think that uncertainty in Washington seems to be the norm in my 27 years here. So I think we've kind of learned to filter that out and focus on the things that are right for the company. There may be tax reform, there may be repatriation, but you can't count on it and you can't wait for it either. So we focused our efforts. I'll return to what you asked last, which is we really focused our efforts in broadening our team, adding some depth, both scientifically and with business development experience, so that we, in fact, have much, much greater capacity to assess things and, in fact, fully engage with our teams assessing a number of different opportunities, which we think could play out over the coming year as we start to make progress in getting partnerships and potential acquisitions together. So we're going to just focus on what's right for Gilead, try to ignore the noise globally in terms of tax reform and deal with the best thing for the company and for the shareholders in the long term. And we really have a great team right now.

謝謝你的提問，科里。首先，就華盛頓而言，我認為在我在這裡生活的27年裡，華盛頓的不確定性似乎已成為常態。所以我覺得我們已經學會了過濾掉這些幹擾因素，專注於對公司有利的事情。可能會有稅制改革，可能會有資金匯回，但你不能期待它，也不能等它。所以我們就集中精力開展工作。我再回到你最後問的問題，那就是我們確實集中精力擴大了團隊規模，在科學和業務發展經驗方面都增加了深度，這樣我們實際上就擁有了更大的能力來評估事物，並能與團隊充分合作，評估各種不同的機會。我們認為，隨著我們開始在建立合作夥伴關係和潛在收購方面取得進展，這些機會可能會在未來一年內得到體現。因此，我們將只關注對吉利德有利的事情，盡量忽略全球稅務改革的噪音，並處理對公司和股東長遠發展最有利的事情。我們現在確實擁有一支非常優秀的團隊。

And our next question comes from Mohit Bansal of Citi.

下一個問題來自花旗銀行的莫希特·班薩爾。

So can you -- so one question on NASH. If you could help us understand the futility analysis you have baked in, in your ASK1 program. And also, like, what is your strategy to -- about data release there? And when do you think we could see those data?

所以，你可以問一個關於NASH的問題。如果您能幫助我們理解您在 ASK1 程式中內建的無效性分析，那就太好了。還有，你們在數據發布方面有什麼策略？你認為我們什麼時候才能看到這些數據？

Yes, there seems to be this rumor in the public that we have a futility analysis. We do not have an interim analysis planned in our Phase III studies. This will be 48-week endpoint with histology. There will be the usual DSMB meetings that mostly look at safety, but there is not a futility or an interim analysis planned. So we're going to carry this study out to 48 weeks, last patient 48 weeks, biopsy, that would constitute the NDA filing.

是的，公眾似乎有傳言說我們進行了一項無效性分析。我們的 III 期研究沒有計劃進行中期分析。這將是為期 48 週的終點事件，並進行組織學檢查。屆時將召開例行的資料安全監測委員會 (DSMB) 會議，主要關注安全性，但沒有計劃進行無效性分析或中期分析。因此，我們將進行這項研究 48 週，最後一名患者在 48 週時進行活檢，這將構成 NDA 申請。

But that study will continue blinded after that.

但之後這項研究將繼續以雙盲方式進行。

The study will continue blinded because we believe that the histology will get us accelerated approval. And in order to get full approval, you need to reach clinical endpoints. And we think they should be at least, as I explained just before, in the 2-year time frame or so.

我們將繼續進行雙盲研究，因為我們相信組織學結果將使我們獲得加速批准。要獲得全面批准，你需要達到臨床終點。正如我剛才解釋的那樣，我們認為至少應該在兩年左右的時間範圍內實現。

And our next question comes from Ying Huang of Bank of America Merrill Lynch.

下一個問題來自美國銀行美林證券的黃穎。

I have a couple of quick ones related to HCV. First one is you had 44,000 patients starting in U.S., so if you flatline, that trend's actually to the high end of the range you provided in the beginning of the year of 150,000 to 175,000 patient starting this year. And if you look at your HCV sales, again, if you flatline to times 4, it's actually above your range. So I was wondering, what do you see in the rest of the year, the next 3 quarters? What could cause that patient start and also the sales to trend down from 1Q level? And then, another related question coming from the comments from Merck and AbbVie on HCV. I think, they had a little bit different opinion. Merck was saying that they continue to see patients trending down, patient starts. But then -- I'm sorry, AbbVie was saying that. But they have different opinion on where the long-term trend is going. So I was wondering if you can provide any color on that.

我這裡還有幾個關於C型肝炎病毒的小問題。首先，你們在美國有 44,000 名患者開始接受治療，所以如果保持平穩，這個趨勢實際上是達到了你們年初提供的 150,000 至 175,000 名患者開始接受治療範圍的高端。如果你看一下你的HCV銷量，同樣地，如果你的銷量穩定在4倍左右，實際上已經超過了你的預期範圍。所以我想知道，您對今年剩餘時間，也就是接下來的三個季度有什麼看法？是什麼原因導致患者數量增加，銷售額從第一季水準下降？此外，默克和艾伯維就丙型肝炎病毒發表的評論也引出了另一個相關問題。我認為，他們的觀點略有不同。默克公司表示，他們發現患者數量持續下降，患者開始數量也隨之減少。但是——抱歉，是艾伯維公司這麼說的。但他們對長期趨勢走向有不同的看法。所以我想知道您是否能提供一些相關資訊。

Ying, it's Kevin. Let me try and take a stab at that. I mean, now, let me say right from the start, HCV continues to be a large opportunity, albeit that it's declining. And that decline is happening in every market that we look around the world. In terms of looking at revenues and our performance, we took a very realistic view when we set about our guidance 3 months ago, and really, nothing has changed. We still think the number of 150,000 to 175,000 patient starts in the U.S. is still a very solid number. Yes, you are correct that it was 44,000 treated. But please bear in mind that when you look at revenues, it's a composite that's made up of starts. It's made up of share. It's made up of payer mix. And it's made up of product mix. So there's a number of components that goes into this. It's early in the year. It's just 3 months. Starts can vary from quarter-to-quarter. But we don't see anything right now that would change from where we set our guidance back in February. Yes, and so, I think from what I can see, and it's not for me to comment on other companies in the area, I think pretty much everybody is now seeing this market in a similar fashion. It's large, and it will go on for a long time. I don't think anybody really knows when there will be a turning point. We'll probably only know that turning point when we're 9 to 12 months after that turning point. But clearly, with 1.5 million people diagnosed in the U.S. -- 3 million infected, but 1.5 million diagnosed, there's still a lot of patients to cure. And I think ourselves and probably the general noise in the market will encourage people to step forward and be treated. And as Jim described earlier, our DTC campaigns are really focused on that.

瑩，我是凱文。讓我試著回答一下。我的意思是，首先我要說的是，儘管丙型肝炎的發生率正在下降，但它仍然是一個巨大的機會。而且，這種下滑趨勢在我們環顧全球的每個市場都在發生。就收入和業績而言，我們在 3 個月前製定業績指引時採取了非常務實的態度，而且實際上，情況並沒有改變。我們仍然認為美國每年新增患者人數在 15 萬至 17.5 萬之間是一個非常可靠的數字。是的，你說得對，接受治療的人數是 44,000 人。但請記住，您查看的收入是由各個項目組成的綜合收入。它由股份組成。它由支付方組合構成。它由產品組合構成。所以這其中包含許多組成部分。現在才年初。才三個月而已。每個季度的開局情況可能有所不同。但目前來看，我們還沒有看到任何會改變我們在二月制定的指導方針的情況。是的，所以，就我所見，我不方便評論該地區的其他公司，但我認為現在幾乎每個人都以類似的方式看待這個市場。它規模很大，而且會持續很長時間。我認為沒有人真正知道何時會出現轉折點。我們可能只有在轉捩點發生後的9到12個月才能知道那個轉捩點是什麼。但很顯然，美國有 150 萬人確診——300 萬人感染，但只有 150 萬人確診，仍有許多病人需要治療。我認為我們自身以及市場上的普遍輿論都會鼓勵人們站出來接受治療。正如吉姆之前所描述的那樣，我們的 DTC 行銷活動正是專注於此。

And our next question comes from Phil Nadeau of Cowen.

下一個問題來自 Cowen 公司的 Phil Nadeau。

One for John, kind of a broad, big picture question. John, last year, there was some talk of Gilead providing a strategic overview early in 2017 and discussing the -- your strategic imperatives in a bit more detail. It seems like that has obviously not happened. But I'm curious, is that still something that we can expect? Is there going to be a time when you will more definitively define your strategy? Or is it just going to be piecemeal where we'll kind of see things develop as they do?

這個問題問約翰，比較廣泛，比較宏觀。約翰，去年曾有消息稱，吉利德將在 2017 年初提供一份策略概述，並更詳細地討論——你的戰略要務。顯然，這種情況並沒有發生。但我很好奇，我們還能期待這種情況發生嗎？您是否會在某個時候更明確地闡述您的策略？還是說會採取零敲碎打的方式，讓我們看著事情慢慢發展？

Well, first of all, Phil, I don't recall ever saying that we're going to have a specific unveiling of a strategy. And strategies for companies are an ongoing process, not an event. And so what you have seen in our different areas, I mean, really, think about our strategies over the last few years, we wanted to stabilize and then grow HCV products by the introduction of TAF and additional STRs. We wanted to round out our HCV portfolio with SOF/VEL/VOX, so we'd have an answer for every patient within our portfolio. We did that very successfully last year, and then, we brought Vemlidy to market to help stabilize the HBV market and provide a really good foundation for the company. We're making forays into NASH, as we described, more compounds that we've acquired and are building upon. We may do more there. We're building really nicely in filgotinib. I think we have a really great opportunity with filgotinib to accelerate the clinical development time lines now that baricitinib seems to have a setback, which could provide greater upside for us as well if that is significantly delayed. So those are 2 different areas where we're continuing to invest. And you'll see, with filgotinib, we're going to embark upon other studies. For example, we have a Syk inhibitor that could be also useful in RA, and that may be combinable with filgotinib. With regard to future legs of the stool, I think it's pretty clear, we're looking for another avenue to increase our opportunity for revenue and also for helping patients with the considerable heft that we have. And it's clear, we've been focusing on oncology with the question, is there an area where we can use our resources to accelerate products to market and build a meaningful franchise in oncology? And that was the hiring of Alessandro Riva. That was the foray we made with our business development people to broaden and then to look at other things that can build this. And so I feel very good that we've got a number of different ways to accelerate growth for the company in the future so that a decade from now, we're a very different company, having reinvented ourselves beyond antivirals into really a multi-therapeutic area company. And I feel very good about where we are, and we'll continue to try to enhance that as well. So that's our strategy.

首先，菲爾，我不記得我說過我們會具體公佈一項戰略。企業策略是一個持續的過程，而不是一個事件。因此，您在我們各個領域所看到的，我的意思是，真的，想想我們過去幾年的策略，我們希望透過引入TAF和其他STR來穩定和發展HCV產品。我們希望透過 SOF/VEL/VOX 來完善我們的 HCV 產品組合，以便我們能夠為產品組合中的每位患者提供解決方案。去年我們非常成功地做到了這一點，然後，我們將 Vemlidy 推向市場，以幫助穩定 HBV 市場，並為公司奠定了良好的基礎。正如我們之前所述，我們正在進入 NASH 領域，開發更多我們已經獲得並正在建造的化合物。我們或許會在那裡進行更多工作。我們在filgotinib方面進展非常順利。我認為，既然巴瑞替尼的研發似乎遭遇了挫折，我們現在有了一個很好的機會，可以利用filgotinib加快臨床開發進程；如果巴瑞替尼的研發進程被大幅推遲，這也能為我們帶來更大的收益。所以，這是我們持續投資的兩個不同領域。你會發現，我們將利用 filgotinib 進行其他研究。例如，我們有一種 Syk 抑制劑，它也可能對 RA 有用，並且可能與 filgotinib 聯合使用。至於未來的發展方向，我認為很明顯，我們正在尋找其他途徑來增加收入機會，並利用我們擁有的巨大實力來幫助患者。很顯然，我們一直專注於腫瘤學領域，思考的問題是，我們能否利用自身的資源，加速產品上市，並在腫瘤學領域建立有意義的業務？於是，亞歷山德羅·里瓦被聘用了。這是我們與業務拓展人員一起進行的嘗試，目的是擴大範圍，並尋找其他可以成長的因素。因此，我感到非常欣慰，我們有很多不同的方法來加速公司未來的發展，這樣十年後，我們將成為一家截然不同的公司，不再局限於抗病毒藥物，而是真正成為一家多元化治療領域的公司。我對我們目前的狀況感到非常滿意，我們也會繼續努力提升這一點。這就是我們的策略。

And our next question comes from Umer Raffat of Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

I just wanted to zoom in a little bit on the TAF patent state. And some of your prior commentary seems to imply that you're guiding to a 2025 patent expiry for TAF-based regimens. And we're seeing some patents listed all the way out to 2032. And just wanted to understand: a, how you think about those patents; and b, in your base case, do you consider using those patents in any possible patent litigation that comes up down the road?

我只是想稍微放大一下TAF專利狀態。你之前的一些評論似乎暗示，你認為基於​​ TAF 的治療方案的專利將於 2025 年到期。我們看到一些專利的申請期限甚至排到了 2032 年。我只是想了解：a，您如何看待這些專利；b，在您的基本情況下，您是否考慮在未來可能出現的任何專利訴訟中使用這些專利？

Well, first, I'm not going to comment on future patent litigation of what we will or won't do. I don't have my attorney with me, so I'd be loath to say anything. With regard to TAF itself, the TAF patent is out through 2025. What you're seeing in additional patents is, of course, as we have bictegravir and other products that we're developing, those will have longer product patents, of course. And so those products and combination products may go out to a much longer date than that. And as we continue to invent other molecules for HIV, we're not done, we're still looking at, for example, drugs for salvage. Those will have additionally long patent lives as well. So it will be somewhat of a laddered portfolio of patent expirations going out well into 2030.

首先，我不會對未來可能出現的專利訴訟，以及我們將採取或不採取的行動發表評論。我的律師不在身邊，所以我不太願意說任何話。至於 TAF 本身，TAF 的專利有效期至 2025 年。當然，您在其他專利中看到的是，我們有比克替拉韋和我們正在開發的其​​他產品，這些產品的專利保護期當然會更長。因此，這些產品和組合產品的保質期可能會比這長得多。而且，隨著我們不斷研發其他治療 HIV 的分子，我們的工作還沒有結束，我們仍在研究，例如，用於挽救 HIV 的藥物。此外，這些專利也將擁有很長的專利保護期。因此，專利到期將呈現階梯式分佈，一直持續到 2030 年。

2033 for bictegravir.

比克替拉韋的上市時間為 2033 年。

Thank you. 2033, Sung has corrected me, for bictegravir.

謝謝。2033 年，Sung 糾正了我，應該是比克替拉韋。

And our next question comes from Katherine Breedis of Stifel.

我們的下一個問題來自 Stifel 公司的 Katherine Breedis。

As a follow-up to the early exciting data for your NASH portfolio that were featured at EASL, I was wondering if you could provide some thoughts about what you think the time line for potential patient recruitment might be, particularly for selonsertib in Phase III, which, again, looked very compelling, but we've seen from other recent competitors some enrollment delays.

繼您在 EASL 上公佈的 NASH 產品組合早期激動人心的數據之後，我想請您談談您對潛在患者招募時間表的看法，特別是 selonsertib 的 III 期臨床試驗，該試驗看起來非常有吸引力，但我們從其他最近的競爭對手那裡看到了一些入組延遲的情況。

Katherine, honestly, it's a little bit too early to talk about where we are in patient recruitment because I always want to get to 1/4 or 1/3 into the recruitment phase to be able to make intelligent projections. But clearly, what I can tell you is the STELLAR 4 study, which is the one in cirrhotic patients, is enrolling very, very fast. And there are 2 obvious reasons: no competition, number one; and unmet need with a population that is very ready to enroll in a study that has the potential to help them and to make their fibrosis better. So I want to -- the answer was a little bit qualitative. Again, to quantitatively answer it, it's too early. But it is also clear that we might have STELLAR 4 enrolled much sooner than STELLAR 3, in which case, we would file with STELLAR 4 only. Of course, this has to be discussed with regulatory...

凱瑟琳，說實話，現在談論我們在病患招募方面取得的進展還為時過早，因為我總是希望招募工作能進行到 1/4 或 1/3 的階段，以便能夠做出合理的預測。但很顯然，我可以告訴你們的是，STELLAR 4 研究（針對肝硬化患者的研究）正在非常非常迅速地招募患者。原因顯而易見：第一，沒有競爭；第二，存在未被滿足的需求，有相當一部分人群非常願意參與一項有可能幫助他們並改善其纖維化狀況的研究。所以我想說的是──答案有點定性。同樣，現在要給定量答案還為時過早。但很明顯，STELLAR 4 的註冊時間可能會比 STELLAR 3 早得多，在這種情況下，我們將只提交 STELLAR 4 的申請。當然，這需要與監管機構討論…

Yes, I'd say we have the potential to file early, depending on the data and the safety and risk-benefit.

是的，我認為我們有可能提前提交申請，這取決於數據、安全性和風險收益比。

I think it's also important to say, Norbert, that we know these -- we know many of these sites very, very well from our HCV program. So...

諾伯特，我認為還有一點很重要，那就是我們了解這些——我們從丙型肝炎防治計畫中對其中許多地方都非常非常了解。所以...

Yes, these the same -- almost -- many times, the same investigators. Yes.

是的，很多時候都是同樣的調查人員──幾乎都是同樣的調查人員。是的。

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。

Just a couple of more on hep C. I was wondering if you have data yet on the number of new diagnoses in the U.S. in 2016. I know you provided that in the past for 2015. And then, can you tell us the contribution from the VA this quarter? And then, ex U.S. market share, looks like has been declining on a dollar basis since early '16. Anything you guys can do to stabilize that?

關於丙肝還有幾個問題。我想知道您是否有2016年美國新增丙型肝炎病例數的相關數據。我知道你過去在 2015 年提供過這項服務。那麼，您能否告知我們本季退伍軍人事務部的貢獻？而且，從美國市場份額來看，自 2016 年初以來，以美元計價的市佔率似乎一直在下降。你們有辦法可以穩定一下嗎？

Terence, this is Kevin. No, it's just too early. We haven't got the '16 data yet, so sorry. It's not that we're holding this back at all. It's just not available. We're hoping maybe going into the second quarter or middle of the year that we'd have that data. But no, we don't have '16. I'll let Jim take the VA.

特倫斯，這位是凱文。不，現在還太早了。我們還沒有 2016 年的數據，抱歉。並不是說我們故意隱瞞什麼。目前還沒有貨。我們希望在第二季或年中時能夠獲得這些數據。但是，我們沒有 '16'。我讓吉姆去退伍軍人事務部吧。

Sure. So yes, the VA, as you know, in the past, has been, at times, 1 in 4 patient starts for us in any given quarter. The VA is experiencing the same dynamics outside of the VA where we are seeing a steady, gradual decline in the number of treated patients, due largely to the changing profile of patients under care. We're seeing it actually in a little bit more of an accelerated manner in the VA simply because they were so efficient and so effective in getting their folks into care and getting them treated. So they actually have been able to treat about 50% of their population. So we would anticipate that the VA would continue to represent a smaller and smaller percentage of our overall treated patient population.

當然。是的，如您所知，在過去，退伍軍人事務部 (VA) 的患者數量有時會占到我們每個季度患者總數的四分之一。退伍軍人事務部 (VA) 也面臨著與 VA 外部相同的動態，我們看到接受治療的患者人數穩步、逐漸下降，這主要是由於接受治療的患者組成發生了變化。實際上，我們在退伍軍人事務部 (VA) 看到這種情況加速發展，原因很簡單，因為他們在讓病人獲得護理和治療方面非常有效率。所以他們實際上已經能夠治療大約 50% 的人口。因此，我們預計退伍軍人事務部 (VA) 在我們接受治療的患者總數中所佔的比例將繼續越來越小。

But it's important to say, Jim, that we don't see -- or we don't hear of any budget restrictions from a VA point of view.

但吉姆，需要說明的是，我們沒有看到──或者說沒有聽說退伍軍人事務部有任何預算限制。

Yes. And the last one was on Europe...

是的。最後一篇是關於歐洲的…

The market share year-on-year.

市佔率較去年同期變化。

Yes. I'm sorry, the question was?

是的。抱歉，剛才的問題是？

So as you think about market share across Europe, we had about the same number of patients this quarter as we did last quarter. But what you're seeing, you're correct, on a dollar basis, it goes down. And that's somewhat a shift from the patients in the north to the patients in the south, which is sort of a natural, again, evolution because there are more patients in Southern Europe where the prices are lower than there are in Northern Europe where we've had a good run at curing a high percentage of the patients already, so I think that trend will likely continue.

因此，從歐洲市場份額來看，我們本季的患者數量與上季大致相同。但你看到的沒錯，以美元計算，它確實在下降。這在某種程度上是從北方患者向南方患者轉移，這是一種自然而然的演變，因為南歐的患者更多，而南歐的價格比北歐低，我們在北歐已經治癒了很大一部分患者，所以我認為這種趨勢可能會繼續下去。

Yes. And, Terence, as Jim pointed out, we do have the opening of access now in France and Italy. So we're going to be obviously trying to use that opportunity to treat more patients, so that's a very positive situation that we've got right now.

是的。特倫斯，正如吉姆所指出的那樣，我們現在確實可以在法國和義大利獲得准入。所以，我們顯然會嘗試利用這個機會來治療更多的病人，這是我們目前面臨的一個非常積極的情況。

Particularly in France. Yes.

尤其是在法國。是的。

Particularly in France.

尤其是在法國。

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

今天的問答環節到此結束。我謹將發言權交還給李成先生，請他再作補充說明。

Thank you, Candice, 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.

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. 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。節目到此結束。你們可以斷開連結了。祝大家今天過得愉快。