吉利德科學 (GILD) 2018 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Second Quarter 2018 Earnings Conference Call. My name is Candace, and I'll be your conference operator today. (Operator Instructions) And as a reminder, this conference call is being recorded.

女士們、先生們，感謝你們的耐心等待，歡迎參加吉利德科學公司2018年第二季財報電話會議。我叫坎迪斯，今天我將擔任你們的會議接線生。（操作員說明）再次提醒，本次電話會議正在錄音。

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

現在我將把電話交給投資人關係副總裁李成先生。請繼續。

Thank you, Candace, and good afternoon, everyone.

謝謝你，坎迪斯，大家下午好。

Just after market closed today, we issued 2 press releases regarding our CEO John Milligan and earnings results for the second quarter 2018. The press releases and detailed slides on earnings are available on the Investor Relations section of the Gilead website.

今天股市收盤後不久，我們發布了兩份新聞稿，內容涉及我們的執行長約翰·米利根和 2018 年第二季的獲利結果。有關吉利德公司網站的投資者關係部分提供了新聞稿和詳細的收益報告幻燈片。

You will notice a change to how we present product sales in the press release. Previously, we grouped the HIV and HBV together under antiviral product sales. We now show HIV products alone so that you can better understand the performance of this category.

您會注意到我們在新聞稿中呈現產品銷售的方式發生了變化。以前，我們將 HIV 和 HBV 歸類為抗病毒產品銷售。我們現在單獨展示 HIV 產品，以便您更了解該類別的表現。

The speakers on today's call will be: John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; Andrew Cheng, Chief Medical Officer and Executive Vice President; and John McHutchison, Chief Scientific Officer and Head of Research and Development.

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；首席醫療官兼執行副總裁安德魯·程；以及首席科學官兼研發主管約翰·麥克哈奇森。

Before we begin with our prepared comments, let me remind you that we will be making forward-looking statements, including plans and expectations with respect to products, product candidates, financial projections and the use of capital, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in our 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.

在我們開始發表準備好的評論之前，請允許我提醒各位，我們將發表一些前瞻性聲明，包括有關產品、候選產品、財務預測和資本使用的計劃和預期，所有這些都涉及某些我們無法控制的假設、風險和不確定性，這些因素可能導致實際結果與這些聲明存在重大差異。有關這些風險的描述，請參閱我們最新的美國證券交易委員會披露文件和近期發布的新聞稿。此外，吉利德不承擔更新本次電話會議中任何前瞻性聲明的義務。

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

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

I will now turn the call over to John.

現在我將把通話轉給約翰。

Thank you, Sung, and good afternoon, everyone.

謝謝宋，大家午安。

As you saw from our press release, I'll be stepping down as CEO and departing Gilead at the end of this year. It's been an honor to work here for my entire professional career. And now that the company is on solid footing for the future, the board and I have agreed it is a good time to turn the reins over to a new leader.

正如您從我們的新聞稿中看到的那樣，我將在今年年底卸任執行長一職並離開吉利德。能夠在這裡工作到我整個職業生涯，我深感榮幸。現在公司已經為未來奠定了堅實的基礎，董事會和我一致認為，現在是將公司交給新領導人的好時機。

You've seen the strong results from the second quarter. Beyond these numbers, I believe Gilead is in a position of tremendous strength. When I stepped into the role of CEO, there were a number of things I wanted to accomplish on behalf of the company, and I'm very pleased with the progress we have made.

第二季的強勁業績你們已經看到了。除了這些數字之外，我認為基利德公司還處於非常強大的地位。當我擔任執行長一職時，我有很多事情想代表公司完成，我對我們的進展非常滿意。

We have a growing HIV franchise and industry-leading cell therapy program and late-stage pipeline in inflammation and NASH. We've been working at a fast and unrelenting pace for many years, for me nearly 3 decades, and while I'm extremely proud of what this company has accomplished, I'm also looking forward to a well-deserved break and will move on to new and different opportunities.

我們在 HIV 領域擁有不斷成長的業務，在細胞療法方面擁有業界領先的項目，並在發炎和非酒精性脂肪性肝炎 (NASH) 領域擁有後期研發管線。多年來，我們一直以快速而不懈的節奏工作，對我來說，已經將近30年了。雖然我為公司所取得的成就感到無比自豪，但我也期待著享受一段當之無愧的假期，並且去尋找新的、不同的機會。

I want to emphasize that this does not change our mission or the strategic direction of our company. And with the full faith and support of the Board of Directors, we will continue to pursue and execute internal programs as well as external partnerships and transactions that further strengthen our pipeline and our business.

我想強調的是，這不會改變我們公司的使命或策略方向。在董事會的全力信任和支持下，我們將繼續推進和執行內部專案以及外部合作與交易，以進一步加強我們的業務和產品線。

As our press release described, I will be staying in my role until the end of the year while the board has the chance to conduct its search for a new CEO to lead Gilead into its next wave of growth.

正如我們的新聞稿中所述，我將繼續擔任目前的職位至年底，在此期間，董事會將有機會尋找一位新的首席執行官，帶領吉利德進入下一個增長階段。

So let's get to the business at hand, the great results from this past quarter, and I would like to now turn the call over to Robin.

那麼，讓我們進入正題，談談上個季度取得的優異成績，現在我想把電話交給羅賓。

Thank you, John, and good afternoon, everyone.

謝謝你，約翰，大家下午好。

Before I provide an update on the quarter, I'd like to take a moment to thank John for his leadership, commitment and many contributions to Gilead over the years. Personally, I've appreciated your friendship, support, and I wish you well in your future endeavors.

在報告本季業績之前，我想藉此機會感謝約翰多年來對吉利德的領導、奉獻和許多貢獻。我個人非常感激你的友誼和支持，祝福你未來一切順利。

Turning to the business and the results for the quarter, I'll review the financial results and commercial performance, Andrew will provide updates on the HIV portfolio, and then John McHutchison will make a few comments about our pipeline.

接下來談談業務和本季業績，我將回顧財務業績和商業表現，Andrew 將介紹 HIV 產品組合的最新情況，然後 John McHutchison 將對我們的產品線發表一些評論。

We delivered a very strong quarter led by the performance of our HIV franchise, with further stabilization in HCV and continued progress of the Yescarta launch. Total revenues for the second quarter were $5.6 billion, with non-GAAP diluted earnings per share of $1.91. This compares to revenue of $7.1 billion and non-GAAP earnings per share of $2.56 for the same period last year. Non-GAAP earnings per share for the quarter benefited from a settlement of a tax examination, which contributed $0.15 per share and an effective tax rate for the quarter of 13.4%.

本季業績非常強勁，主要得益於 HIV 業務的優異表現，HCV 業務也進一步趨於穩定，Yescarta 的上市也持續取得進展。第二季總營收為 56 億美元，非 GAAP 稀釋後每股收益為 1.91 美元。相比之下，去年同期營收為 71 億美元，非 GAAP 每股收益為 2.56 美元。本季非GAAP每股收益受惠於稅務審查的和解，每股收益增加0.15美元，本季實際稅率為13.4%。

Starting with HIV. Product sales for the second quarter were $3.7 billion, up 13% year-over-year and 16% sequentially. The year-over-year increase was primarily due to the uptake of our Descovy-based regimen with a very strong contribution from Biktarvy in the U.S.

從愛滋病毒開始。第二季產品銷售額為 37 億美元，年增 13%，季增 16%。與上年相比，成長主要歸功於我們基於 Descovy 的療法的普及，其中 Biktarvy 在美國的貢獻非常顯著。

Sequentially, the increase was primarily due to the following factors. First, the seasonal U.S. inventory drawdown observed in the first quarter, which accounted for more than $200 million and did not recur in the second quarter. Second, U.S. payer mix, which is typically about 45% private pay and 55% government, but in the second quarter was approximately equally split between private pay and government segments. We estimate that this benefited the second quarter by approximately $150 million. And third, the continued rapid uptake of Biktarvy in the second quarter.

從順序來看，成長主要歸因於以下因素。首先，第一季出現了美國季節性庫存下降，減少了超過 2 億美元，但第二季沒有再次出現這種情況。其次，美國的支付方組成通常約為 45% 為私人支付，55% 為政府支付，但在第二季度，私人支付和政府支付的比例大致相等。我們估計這將使第二季增加約 1.5 億美元。第三，Biktarvy 在第二季繼續快速普及。

Our U.S. HIV business continues to be a major growth driver, delivering 18% year-over-year revenue growth and 11% year-over-year prescription growth, which reflects the strong underlying demand for Descovy-based regimens. 70% of Gilead's total HIV treatment prescription volume was comprised of Descovy-based regimens. We anticipate this percentage to continue to increase over the coming years.

我們的美國 HIV 業務繼續成為主要的成長動力，實現了 18% 的年收入成長和 11% 的年處方成長，這反映了市場對基於 Descovy 療法的強勁潛在需求。吉利德公司 HIV 治療處方總量的 70% 是基於 Descovy 的治療方案。我們預計這一比例在未來幾年將持續成長。

In the first full quarter, since its approval in February, Biktarvy delivered $183 million in sales in the U.S. Biktarvy also became the #1 regimen for switch patients during the quarter. Based on its current trajectory, we anticipate that Biktarvy will become the #1 single-tablet regimen for treatment-naïve patients and will overtake Genvoya as the most successful launch in HIV history.

自 2 月獲批以來，Biktarvy 在第一個完整季度內在美國的銷售額達到了 1.83 億美元。 Biktarvy 在該季度也成為轉換治療患者的第一治療方案。根據目前的趨勢，我們預計 Biktarvy 將成為初治患者的首選單片療法，並將超越 Genvoya，成為 HIV 史上最成功的上市藥物。

More than 85% of Biktarvy's prescriptions came from switches. Of these switches, approximately 1/4 came from Genvoya and another quarter came from regimens containing dolutegravir. The balance came from older Gilead single- and multi-tablet regimens.

Biktarvy 超過 85% 的處方來自轉換。在這些轉換中，約有 1/4 來自 Genvoya，另有 1/4 來自含有多替拉韋的方案。平衡來自吉利德公司較早推出的單片和多片製劑。

In March, Biktarvy was added to the U.S. Department of Health and Human Services guidelines for the use of antiretroviral agents in adults and adolescents living with HIV as one of the recommended initial regimens. And earlier this week, the Journal of the American Medical Associations published updated treatment guidelines from the International AIDS Society-USA panel, which now includes Biktarvy as a recommended regimen.

今年 3 月，Biktarvy 被美國衛生與公共服務部列入成人和青少年 HIV 感染者抗逆轉錄病毒藥物使用指南，作為推薦的初始治療方案之一。本週早些時候，《美國醫學會雜誌》發表了國際愛滋病協會美國分會專家小組更新的治療指南，其中現在將 Biktarvy 列為推薦療法。

Truvada for PrEP continued to grow, with an estimated 180,000 individuals in the U.S. taking Truvada for PrEP as we exited the quarter. Also in May, the U.S. Food and Drug Administration extended the indication for Truvada for PrEP to include at-risk adolescents.

Truvada 用於 PrEP 的使用量持續成長，截至本季末，估計美國有 18 萬人服用 Truvada 用於 PrEP。同樣在 5 月，美國食品藥物管理局擴大了 Truvada 用於 PrEP 的適應症，將高風險青少年也納入其中。

In the U.S., youth aged 13 to 24 comprised 21% of the approximately 40,000 new infections in 2016 according to the U.S. Centers for Disease Control and Prevention. These statistics demonstrate the need for increased efforts to educate at-risk individuals, particularly young men who have sex with men about risk reduction strategies, including Truvada for PrEP.

根據美國疾病管制與預防中心統計，2016 年美國新增感染病例約 4 萬例，其中 13 至 24 歲的青少年佔 21%。這些統計數據表明，需要加強教育高風險族群，特別是與男性發生性關係的年輕男性，讓他們了解降低風險的策略，包括使用 Truvada 進行 PrEP。

To this end, with strong encouragement from the HIV community, we launched 2 new television campaigns, a nonbranded disease awareness program to reach those unaware of their HIV risk and a branded Truvada commercial. We hope that these 2 campaigns, together with the ongoing educational initiatives across our organization, will further support the advocacy community's efforts to destigmatize HIV and normalize conversations about HIV prevention among those at the highest risk for infection and the health care providers who serve them.

為此，在愛滋病群體的強烈鼓勵下，我們推出了兩項新的電視宣傳活動，一項是針對不了解自身愛滋病風險族群的非品牌疾病意識宣傳活動，另一項是 Truvada 品牌廣告。我們希望這兩項活動，連同我們組織內正在進行的教育活動，能夠進一步支持倡導團體消除對愛滋病毒的污名化，並使高危險群和為他們服務的醫療保健提供者能夠正常談論愛滋病毒預防。

Turning to Europe. HIV sales were down slightly year-over-year due to the availability of generics in several markets, partially offset by an uptake of Descovy-based regimens. These regimens now comprise nearly 60% of our Europe HIV product revenues, reflecting a strong position in patient preference for Descovy-continued regimens over generics.

轉向歐洲。由於多個市場出現了仿製藥，HIV 藥物的銷售額同比略有下降，但 Descovy 療法的普及部分抵消了這一影響。這些治療方案目前占我們歐洲 HIV 產品收入的近 60%，反映出患者更傾向於使用 Descovy 繼續治療方案而不是仿製藥。

Genvoya remained the #1 regimen for naïve and switch patients across the EU5 collectively for the fifth consecutive quarter.

Genvoya 連續第五個季度維持歐盟五國（EU5）初治病患和轉診病患的首選治療方案。

Biktarvy was approved in the EU towards the end of June and immediately launched in Germany and a few other countries. We believe Biktarvy will make significant contributions to our European revenues once pricing and reimbursement are achieved broadly, which can take up to 12 months.

Biktarvy 於 6 月底獲得歐盟批准，並立即在德國和其他一些國家推出。我們相信，一旦定價和報銷問題得到廣泛解決（這可能需要長達 12 個月的時間），Biktarvy 將為我們在歐洲的收入做出重大貢獻。

The performance of our worldwide HIV business was very strong in the first half of the year, and we expect similar results for the second half of the year. The U.S. HIV market will continue to deliver robust year-over-year prescription and revenue growth in the second half of 2018, driven by the continued strong uptake of Biktarvy.

今年上半年，我們全球愛滋病業務表現非常強勁，我們預計下半年也將取得類似的成績。受 Biktarvy 持續強勁的推廣，美國 HIV 市場在 2018 年下半年將繼續保持強勁的處方量和收入同比增長。

Given the payer mix dynamically experienced in Q2, our Q3 U.S. HIV revenues could look similar to Q2.

鑑於第二季支付方組合的動態變化，我們第三季的美國 HIV 收入可能與第二季類似。

Additionally, it is important to note that in Europe, there's typically a third quarter seasonal impact on revenue due to holiday schedules in various countries that also could impact our Q3 revenues compared to Q2. We also expect to see some additional impact from generics in certain European countries. All of these assumptions have been factored into our guidance.

此外，值得注意的是，在歐洲，由於各國的假期安排，第三季通常會對收入產生季節性影響，這也可能會對我們的第三季收入與第二季收入相比產生影響。我們也預計仿製藥在某些歐洲國家會產生一些額外的影響。我們的指導意見已將所有這些假設考慮在內。

Turning to HCV. Product sales for the second quarter were $1 billion, down 65% year-over-year and down 4% sequentially. As anticipated, we are seeing further stabilization of the market, which is reflected in our sequential performance for the quarter.

轉向丙型肝炎。第二季產品銷售額為 10 億美元，年減 65%，季減 4%。正如預期的那樣，我們看到市場進一步趨於穩定，這反映在我們本季的環比業績中。

Patient starts continued to be more predictable, and we still expect a slow and steady decline moving forward.

患者發病率持續趨於可預測，我們仍然預期未來將緩慢且穩定地下降。

Our belief is that the HCV market is durable and will contribute to our revenues in a meaningful way going forward, albeit at declining rates. We will continue to compete for market share across the market segments and geographies with increased promotional efforts and focus behind Epclusa, our pan-genotypic, pan-fibrotic, once daily, single-tablet regimen.

我們相信HCV市場具有永續性，並且在未來將繼續以有意義的方式為我們的收入做出貢獻，儘管成長速度將逐漸放緩。我們將繼續在各個細分市場和地區爭奪市場份額，加強推廣力度，重點推廣我們的泛基因型、泛纖維化、每日一次的單片療法 Epclusa。

Turning to cardiovascular products. Ranexa and Letairis delivered their best quarterly performance ever, with sales of $208 million and $244 million, respectively. As a reminder, the U.S. patent for ambrisentan, the active agent in Letairis, will expire near the end of this month, and we expect this to impact our Letairis sales in the second half of the year.

轉向心血管產品。Ranexa 和 Letairis 分別實現了有史以來最好的季度業績，銷售額分別為 2.08 億美元和 2.44 億美元。提醒各位，Letairis 的活性成分安立生坦的美國專利將於本月底到期，我們預計這將影響我們今年下半年的 Letairis 銷售。

Moving on to cell therapy. Sales of Yescarta were $68 million. We continue to be encouraged by the response from the health care provider and patient communities for the lifesaving potential of Yescarta. We have completed the authorization of more than 60 cancer centers, which cover approximately 80% of the Yescarta-eligible patients in the United States.

接下來談談細胞療法。Yescarta的銷售額為6800萬美元。Yescarta 的救命潛力得到了醫療保健提供者和患者群體的正面回饋，這讓我們倍感鼓舞。我們已經完成了 60 多個癌症中心的授權，這些中心涵蓋了美國約 80% 的 Yescarta 合格患者。

While we continue to work on authorizing additional centers, our focus now turns to working with centers to enhance patient flows. Furthermore, we are educating community oncologists about cell therapy and how they can connect to their patients to cancer centers for appropriate treatment.

在我們繼續努力批准更多中心的同時，我們現在的重點轉向與各中心合作，以改善患者就診流程。此外，我們正在向社區腫瘤醫師普及細胞療法知識，以及他們如何幫助患者聯繫癌症中心接受適當的治療。

In terms of access in the United States, the payer mix has been consistent with expectations. The majority of patients treated with Yescarta were covered by commercial insurance or treated at PPS-exempt centers. We continue to work to provide better access for patients on Medicare. We provided comments to the Centers for Medicare & Medicaid Services as part of the fiscal year 2019 rule-making process to create a DRG code that is reflective of the value that cell therapy provides to patients.

就美國的醫療服務取得而言，支付方組成與預期相符。接受 Yescarta 治療的患者大多享有商業保險或在 PPS 豁免中心接受治療。我們將繼續努力，為參加聯邦醫療保險（Medicare）的患者提供更好的醫療服務。我們向美國醫療保險和醫療補助服務中心提交了意見，作為 2019 財年規則制定過程的一部分，旨在創建一個能夠反映細胞療法為患者帶來的價值的 DRG 代碼。

CMS is expected to announce the final infusion prospective payment system rule in August of this year that will establish inpatient payment rates for the upcoming fiscal year beginning October 1.

美國醫療保險和醫療補助服務中心 (CMS) 預計將於今年 8 月宣布最終的輸液預付制規則，該規則將確定從 10 月 1 日開始的下一個財政年度的住院支付標準。

Last month, we announced that the CHMP adopted a positive opinion on the Marketing Authorization Application for Yescarta in the EU as a treatment for adults with relapsed/refractory diffuse large B lymphoma and primarily large B-cell lymphoma after 2 or more lines of systemic therapy. We expect the European Commission to grant marketing authorization in the third quarter of this year, and our preparations for launch are underway. We plan to complete the authorization of more than 20 centers in the EU by the end of 2018 with our initial launch efforts primarily focused on Germany and France.

上個月，我們宣佈人用藥品委員會 (CHMP) 對 Yescarta 在歐盟的上市許可申請給予了積極意見，該藥物用於治療接受過 2 線或以上系統性治療的複發/難治性瀰漫性大 B 淋巴瘤和原發性大 B 細胞淋巴瘤成人患者。我們預計歐盟委員會將於今年第三季授予上市許可，目前我們的上市準備正在進行中。我們計劃在 2018 年底前完成歐盟 20 多個中心的授權，最初的啟動工作將主要集中在德國和法國。

Now turning to expenses. Non-GAAP R&D expenses were $921 million for the second quarter, up 13% compared to the same period last year, primarily due to our purchase of a priority review voucher in the second quarter and investments in our cell therapy program.

現在來說說費用。第二季非GAAP研發費用為9.21億美元，比去年同期成長13%，主要原因是我們在第二季度購買了優先審查券以及對細胞療法計畫的投資。

Non-GAAP SG&A expenses were $840 million for the second quarter, up 2% compared to the same period last year, primarily due to higher costs to support the growth of our business following the acquisition of Kite. Our non-GAAP effective tax rate in the second quarter was 13.4% compared to 22.8% in the first quarter of this year. The lower rate in the second quarter was due to a favorable settlement of a tax examination. As a result of this favorable impact, we are lowering our full year non-GAAP effective tax guidance to be in the range of 19% to 21%.

第二季非GAAP SG&A費用為8.4億美元，比去年同期成長2%，主要原因是收購Kite後，為支持業務成長而產生的成本增加。今年第二季度，我們的非GAAP有效稅率為13.4%，而今年第一季為22.8%。第二季稅率較低是由於稅務審查結果有利。受此有利影響，我們將全年非GAAP有效稅收預期下調至19%至21%的範圍內。

Moving to our balance sheet. As of June 30, we had $31.7 billion of cash and investments. During the second quarter, we generated $1.6 billion in operating cash flow, including tax payments of $1.5 billion. And we also paid cash dividends of $740 million and repurchased 6.6 million shares of stock for $450 million.

接下來來看看我們的資產負債表。截至6月30日，我們擁有317億美元的現金和投資。第二季度，我們產生了 16 億美元的營運現金流，其中包括 15 億美元的稅金支出。此外，我們還支付了 7.4 億美元的現金股息，並以 4.5 億美元的價格回購了 660 萬股股票。

The year is progressing consistent with our expectations, and we are reiterating our full year guidance with the exception of the non-GAAP effective tax rate, which has been lowered. Also, the diluted EPS impact of GAAP to non-GAAP adjustment has been increased from a range of $1.41 to $1.51 per share to $1.50 to $1.60 per share. Details of our guidance can be found on Slide 35 in the earnings results presentation.

今年的進展與我們的預期一致，我們重申全年業績指引，但非GAAP有效稅率已下調。此外，GAAP 調整為非 GAAP 調整後，稀釋每股盈餘的影響範圍已從每股 1.41 美元至 1.51 美元增加到每股 1.50 美元至 1.60 美元。有關我們業績指引的詳細信息，請參閱盈利結果簡報中的第 35 頁。

One area I'd like to address before closing is U.S. pricing. We did not implement midyear price increases on any of our products and no -- have no plans to do so for at least 6 months. As you know, in HCV, we have responded to the evolving, increasingly competitive market by providing payers with substantial discounts. We are confident that our net pricing is competitive and is delivering value for patients in the broader health care system.

在結束之前，我想談談美國定價問題。我們沒有對任何產品實施年中漲價，而且至少在未來 6 個月內也沒有這樣的計畫。如您所知，在C型肝炎領域，我們透過向支付方提供大幅折扣來應對不斷變化、競爭日益激烈的市場。我們相信，我們的淨定價具有競爭力，並且能夠為更廣泛的醫療保健系統中的患者帶來價值。

In closing, we continue to believe that 2018 is a trough year for Gilead on which we can grow in the future. Our confidence in our future is supported by strong and growing HIV business led by the launch of Biktarvy in the U.S., increasing momentum in our cell therapy business, progress in the emerging R&D areas of NASH and inflammation and a healthy balance sheet, which equips us to invest in future opportunities to create long-term shareholder value.

最後，我們仍然認為 2018 年是吉利德的低谷年，未來我們可以藉此實現成長。我們對未來的信心源於強勁且不斷增長的 HIV 業務（以 Biktarvy 在美國的上市為代表）、日益強勁的細胞療法業務發展勢頭、NASH 和炎症等新興研發領域的進展以及健康的資產負債表，這使我們能夠投資未來的機會，創造長期的股東價值。

I will now turn the call over to Andrew.

現在我將把通話轉給安德魯。

Thank you, Robin.

謝謝你，羅賓。

It's timely that the 22nd International AIDS Conference is taking place this week in Amsterdam. The World AIDS Conference represents the largest conference on any global health issue in the world and has become known as a venue where researchers, policymakers, advocates collaborate to help drive an evidence-based response to the HIV epidemic.

第22屆國際愛滋病大會本週在阿姆斯特丹召開，可謂適時。世界愛滋病大會是全球規模最大的全球衛生議題會議，它已成為研究人員、政策制定者和倡議者合作，共同推動以證據為基礎應對愛滋病疫情的場所。

I'd like to provide some highlights of Gilead's vision for HIV treatment, prevention and cure and how we intend to sustain and build on our leadership position. I will summarize some of the exciting data presented at Amsterdam this week that provide context for what we see as remaining unmet needs in this field.

我想重點介紹吉利德在愛滋病治療、預防和治癒方面的願景，以及我們打算如何保持和鞏固我們的領導地位。我將總結本週在阿姆斯特丹公佈的一些令人興奮的數據，這些數據為我們認為該領域仍然存在的未滿足的需求提供了背景。

I'd also like to congratulate our partner Janssen on the approval last week of SYMTUZA by the U.S. Food and Drug Administration. SYMTUZA is the fourth Descovy-based, single-tablet regimen and the first commercially available, single-tablet regimen containing a protease inhibitor, an important option for patients who previously had to consume 2 or more tablets each day.

我還要祝賀我們的合作夥伴楊森公司上週獲得了美國食品藥物管理局對SYMTUZA的批准。SYMTUZA 是第四種基於 Descovy 的單片療法，也是第一種市售的含有蛋白酶抑制劑的單片療法，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。

Among the results we presented at the International AIDS Conference were data from a pooled analysis that further demonstrates the lack of resistance seen across the Biktarvy clinical program. This analysis generated -- evaluated the efficacy of Biktarvy among patients with high base volume HIV RNA greater than 100,000 copies per milliliter and with a baseline CD4 cell count below 200 per microliter. Biktarvy sustained virologic suppression with no treatment-emergent resistance to 48 weeks, and 99% of patients in both subgroups achieved HIV RNA less than 50 copies per ml.

我們在國際愛滋病大會上發表的結果中，有一項匯總分析的數據進一步證明了 Biktarvy 臨床計畫中未出現抗藥性。該分析評估了 Biktarvy 對 HIV RNA 基礎體積大於 100,000 拷貝/毫升且基線 CD4 細胞計數低於 200/微升的患者的效果。Biktarvy 持續抑制病毒量長達 48 週，未出現治療抗藥性，兩個亞組中 99% 的患者 HIV RNA 均低於每毫升 50 個拷貝。

For some people living with HIV, drug resistance is already a fact of life, and we are also advancing molecules to meet their needs. GS-9131, a novel nucleotide reverse transcriptase inhibitor, is currently being studied in a Phase II trial in people living with HIV who are resistant to nucleosides, and we look forward to sharing updates on the study in the future.

對於一些感染愛滋病毒的人來說，抗藥性已經成為現實，我們也正在研發能夠滿足他們需求的分子。GS-9131 是一種新型核苷酸逆轉錄酶抑制劑，目前正在對感染 HIV 且對核苷類藥物抗藥性的患者進行 II 期臨床試驗，我們期待在未來分享研究的最新進展。

Although once daily, single-tablet regimens have set the current standard of -- for convenience, we recognize that even once daily dosing can be challenging or impractical for some people living with or at risk for HIV infection. I'm also pleased to share an update on a long active formulation of GS-6207, our novel HIV capsid inhibitor. This inhibitor is the most potent anti-HIV molecule ever recorded, and results in therapeutically active blood levels lasting greater than 90 days after a single subcutaneous injection in preclinical species. Since that time, we have moved a clinical formulation into the clinic. And similar to our animal data, we have established in healthy volunteers that a single subcutaneous dose of the capsid inhibitor results in therapeutically relevant concentrations for greater than 60 days.

雖然每日一次的單片給藥方案已成為目前的標準——為了方便起見，我們認識到，即使是每日一次的給藥方案，對於一些感染或有感染 HIV 風險的人來說也可能具有挑戰性或不切實際。我也很高興與大家分享我們新型 HIV 衣殼抑制劑 GS-6207 的長效活性製劑的最新進展。這種抑制劑是迄今為止記錄到的最有效的抗 HIV 分子，在臨床前動物中，單次皮下注射後，其治療活性血藥濃度可持續 90 天以上。自那時起，我們已將臨床配方推進到臨床應用。與我們的動物數據類似，我們在健康志願者身上證實，單次皮下注射衣殼抑制劑可使治療相關濃度持續超過 60 天。

Our goal is an effective subcutaneous product that can be self-administered every 3 months, which could provide an important option for the significant number of people who are unable to adhere to daily oral regimens.

我們的目標是研發一種有效的皮下注射產品，患者可以每 3 個月自行注射一次，這將為大量無法堅持每日口服藥物治療的人提供一個重要的選擇。

Prevention efforts also took center stage at the conference this week. We now have compelling evidence correlating the use of Truvada for PrEP with declines in new HIV infections in the United States. In an analysis of state-level data conducted through a collaboration by Gilead, Emory University and the Centers for Disease Control and Prevention and presented this week at the conference states that -- states with the highest utilization of Truvada for PrEP from 2012 to 2016 showed significant declines in a number of new HIV infections, while states with the lowest use reported increases in new infection. These data underscore the importance for Truvada for PrEP as an effective public health intervention in the ongoing efforts to decrease new HIV infections.

本週的會議也重點討論了預防措施。我們現在有確鑿的證據表明，使用 Truvada 進行暴露前預防與美國新增 HIV 感染病例的下降之間存在關聯。吉利德、埃默里大學和疾病管制與預防中心合作進行的一項州級數據分析，在本週的會議上公佈，該分析指出，2012 年至 2016 年間，Truvada 用於 PrEP 的利用率最高的州，新增 HIV 感染病例數量顯著下降；而利用率最低的州，新增感染病例數則有所增加。這些數據強調了 Truvada 作為 PrEP 的一種有效公共衛生幹預措施的重要性，有助於持續減少新的 HIV 感染。

Turning to our HIV cure efforts. One investigational agent is GS-9620, our toll-like receptor 7 agonist, which activates certain immune cells that are important for eliminating infected cells. And second investigational agent is GS-9722, an anti-HIV envelope broadly neutralizing antibody that can kill infected cells. Combination studies are planned following the completion of dose-ranging studies for each compound.

轉向我們的愛滋病治癒工作。其中一種研究藥物是 GS-9620，它是我們的 Toll 樣受體 7 激動劑，可活化某些對清除受感染細胞至關重要的免疫細胞。第二種研究藥物是 GS-9722，它是一種抗 HIV 包膜的廣譜中和抗體，可以殺死受感染的細胞。在完成每種化合物的劑量範圍研究後，將計劃進行聯合研究。

In summary, Gilead remains deeply committed to leading and innovating HIV across the spectrum of care from prevention to treatment to HIV cure. We are continuing to make significant progress with Truvada in combination with safer sex practices as a means of preventing new HIV infections. We have multiple medicines able to address the needs of people living with HIV, including 6 single-tablet regimens. We are working to address remaining needs in both prevention and treatment, and we remain focused on pursuing discovery of new research that could one day lead to a cure for HIV. We have been the leader in HIV for many years and intend to remain at the forefront of these efforts for as long as HIV is a threat to the health of people worldwide.

總而言之，吉利德始終致力於引領和創新愛滋病防治的各個方面，從預防到治療再到治癒。我們正在繼續透過 Truvada 與安全性行為相結合的方式來預防新的 HIV 感染，並取得顯著進展。我們有多種藥物可以滿足愛滋病毒感染者的需求，其中包括 6 種單片療法。我們正在努力解決預防和治療方面仍然存在的需求，我們將繼續專注於探索新的研究，以期有朝一日能夠治癒愛滋病。多年來，我們一直是愛滋病防治領域的領導者，只要愛滋病仍然威脅著全世界人民的健康，我們就將繼續走在防治愛滋病的最前線。

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

現在我將把電話交給約翰·麥克哈奇森。

Thank you, Andrew, and thank you, everyone, for joining us today.

謝謝安德魯，也謝謝各位今天蒞臨。

As you heard from Andrew, we are advancing pipeline candidates across the continuum of care for patients with HIV infection. We are also making progress in other therapeutic areas. And I'd like to spend a few minutes highlighting peer accomplishments from the first half of this year as well as additional milestones to look forward to in the second half, starting with cell therapies.

正如安德魯所說，我們正在推動針對 HIV 感染患者整個治療過程的候選藥物研發。我們在其他治療領域也取得了進展。我想花幾分鐘時間重點介紹今年上半年同行們所取得的成就，以及下半年值得期待的其他里程碑，首先是細胞療法。

As we anticipate regulatory approval of Yescarta in Europe, we're taking steps to establish worldwide manufacturing capabilities for cell therapy by leasing a new facility in the Netherlands. We anticipate this new European manufacturing facility to be fully operational in 2020, with the capacity to manufacture personalized cell therapies in closer geographic proximity to the patients who will receive them, therefore potentially shortening the turnaround time for people who urgently need such care.

隨著我們預期 Yescarta 將在歐洲獲得監管部門的批准，我們正在採取措施，透過在荷蘭租賃一家新工廠來建立全球細胞療法生產能力。我們預計這座新的歐洲製造工廠將於 2020 年全面投入運營，屆時將有能力在更靠近接受治療的患者的地方生產個性化細胞療法，從而有可能縮短急需此類治療的患者的治療週期。

All of us at Gilead and Kite share excitement about both the work being done to launch Yescarta and to advance potential new cell therapies that could help a wider range of patients in the future. I'm particularly enthusiastic about ZUMA-7, our ongoing Phase III study comparing Yescarta to the standard of care in second-line treatment of patients with diffuse large B-cell lymphoma. The current standard of care for these patients is salvage chemotherapy often followed by an autologous stem cell transplant. If successful, the study would support the use of Yescarta and the earlier lines of therapy and could one day spare people from having to receive stem cell transplantation with all of its concomitant or attendant difficulties and complications.

吉利德和凱特的所有員工都對Yescarta的上市工作以及推進未來可能幫助更多患者的新型細胞療法感到興奮。我特別對 ZUMA-7 充滿熱情，這是一項正在進行的 III 期研究，旨在比較 Yescarta 與瀰漫性大 B 細胞淋巴瘤患者二線治療的標準療法。目前這些患者的標準治療方案是挽救性化療，通常隨後進行自體幹細胞移植。如果研究成功，將支持使用 Yescarta 和早期療法，並有可能在未來某一天使人們免於接受幹細胞移植及其伴隨的所有困難和併發症。

As significant of an advance as Yescarta represents, it is also just the beginning. It's critical but an even greater percentage of patients respond to therapy, and that treatment becomes even safer and better tolerated so that we can treat people sooner. I believe that with the pipeline programs we have and the technology gains through recent partnerships, we can make this a reality.

Yescarta 代表著一項意義重大的進步，但這只是個開始。至關重要的是，有更高比例的患者對治療有反應，而且治療變得更加安全、耐受性更好，這樣我們就可以更快地治療患者。我相信，憑藉我們現有的專案儲備和近期合作帶來的技術進步，我們可以將這一目標變為現實。

In the 10 months since we acquired Kite, we have initiated 7 acquisitions, investments or partnerships that augment our efforts to more rapidly bring forward cellular therapy, treat a broader range of hematological malignancies and also solid tumors.

自從我們收購 Kite 以來的 10 個月裡，我們啟動了 7 項收購、投資或合作，以增強我們加快推進細胞療法、治療更廣泛的血液惡性腫瘤以及實體瘤的努力。

Lastly, we announced the strategic collaboration with Gadeta, a privately held company that focuses on the discovery and development of novel cancer immunotherapies based on gamma delta T-cell receptors.

最後，我們宣布與 Gadeta 達成策略合作，Gadeta 是一家專注於基於 γδ T 細胞受體的新型癌症免疫療法發現和開發的私人公司。

During the quarter, we also announced a new cooperative research and development agreement or a CRADA with the National Cancer Institute to develop adoptive cell therapies targeting patient-specific tumor neoantigens. Neoantigens are mutations found on the surface of cancer cells that are unique to each person and their tumor, offering the potential for more targeted antitumor activity, particularly in the realm of solid tumors. Together these research collaborations add to our capabilities in research and cell manufacturing, and they broaden our approach to developing potentially effective therapies for additional types of cancers, including solid tumors.

本季度，我們也宣布與美國國家癌症研究所達成一項新的合作研發協議（CRADA），以開發針對患者特異性腫瘤新抗原的過繼性細胞療法。新抗原是癌細胞表面發現的突變，每個個體及其腫瘤都具有獨特的新抗原，這為更有針對性的抗腫瘤活性提供了可能，尤其是在實體瘤領域。這些研究合作共同增強了我們在研究和細胞製造方面的能力，並拓寬了我們開發針對其他類型癌症（包括實體瘤）的潛在有效療法的方法。

Moving to liver disease now. Our 2 ongoing Phase III trials, STELLAR 3 and STELLAR 4, evaluating selonsertib, our ASK1 inhibitor, in patients with F3 or bridging fibrosis and F4 or cirrhosis, were fully enrolled earlier this year. And data from these studies should be available in the first half of 2019. If positive, we expect to be in a position to file for approval in mid-2019. Under this time line, we believe selonsertib could be the first NDA and the first product approved for the treatment of patients with NASH. From a commercial perspective, our teams are also currently building all the necessary capabilities to develop this new market.

接下來談談肝病。我們正在進行的 2 項 III 期試驗 STELLAR 3 和 STELLAR 4 評估了我們的 ASK1 抑制劑 selonsertib 對 F3 或橋接纖維化以及 F4 或肝硬化患者的療效，這兩項試驗已於今年早些時候完成全部入組。這些研究的數據應該會在 2019 年上半年公佈。如果結果為陽性，我們預計將在 2019 年年中提交批准申請。按照這個時間表，我們相信 selonsertib 可能是第一個獲得 NDA 批准並獲準用於治療 NASH 患者的產品。從商業角度來看，我們的團隊目前也在建立開發這個新市場所需的一切能力。

Separately, we've discontinued the development of selonsertib for severe alcoholic hepatitis after a Phase II study of selonsertib in combination with prednisolone showed a lack of benefit on mortality, which is the primary efficacy end point of the trial. Now it's important to note that alcoholic hepatitis and NASH are 2 very distinct diseases. Patients with severe alcoholic hepatitis have advanced decompensated disease with severe hepatic dysfunction and a high 30-day mortality, independent of any therapy. This is completely different from patients in NASH clinical studies and from most patients with NASH in general, who have preserved liver function and they have compensated disease. Additional details from the study will be shared at an upcoming scientific conference later this year.

另外，在 selonsertib 與潑尼松龍聯合治療重度酒精性肝炎的 II 期研究顯示，該藥物對降低死亡率（該試驗的主要療效終點）沒有益處之後，我們已停止了 selonsertib 的研發。需要注意的是，酒精性肝炎和非酒精性脂肪性肝炎是兩種非常不同的疾病。重症酒精性肝炎患者病情已發展至失代償期，伴隨嚴重的肝功能障礙，且30天內死亡率很高，與任何治療無關。這與 NASH 臨床研究中的患者以及大多數 NASH 患者的情況完全不同，他們的肝功能得以保留，且病情已得到代償。該研究的更多細節將在今年稍後舉行的科學會議上公佈。

Turning to inflammation. We continue to be enthusiastic about filgotinib. In May, Gilead and Galapagos announced that EQUATOR, our Phase II study of filgotinib in adults with moderate to severe psoriatic arthritis achieved its primary end point of improvement in the signs and symptoms of psoriatic arthritis at week 16, as assessed by the American College of Rheumatology 20% improvement score. The filgotinib arm achieved an ACR20 response of 80% compared to 33% for the placebo arm. These results indicated filgotinib has the potential to have a significant effect on the signs and symptoms of psoriatic arthritis, a condition for which there is also a high, unmet medical need.

轉為發炎。我們依然對filgotinib充滿熱情。5 月，吉利德和 Galapagos 宣布，針對中重度乾癬關節炎成年患者的 filgotinib II 期研究 EQUATOR 達到了其主要終點，即在第 16 週時銀屑病關節炎的體徵和症狀得到改善，這是根據美國風濕病學會 20% 改善評分評估的結果。filgotinib 組的 ACR20 緩解率為 80%，而安慰劑組為 33%。這些結果表明，filgotinib 有可能對乾癬性關節炎的徵兆和症狀產生顯著影響，而乾癬性關節炎也是一種存在著巨大未滿足醫療需求的疾病。

We also announced that an independent Data Monitoring Committee conducted a planned interim futility analysis of the filgotinib Phase IIb/III ulcerative colitis study named SELECTION. The DMC recommended that the study proceed into the Phase III portion as planned in both biologic experienced and biologic-naïve patients.

我們還宣布，一個獨立的數據監測委員會對名為 SELECTION 的 filgotinib IIb/III 期潰瘍性結腸炎研究進行了計劃中的中期無效性分析。DMC建議研究按計畫進入III期部分，研究對象包括有生物製劑治療經驗的患者和無生物製劑治療經驗的患者。

In rheumatoid arthritis, 3 studies, Phase I, II and III, are fully enrolled. Phase II compares filgotinib to placebo, each added to conventional disease-modifying antirheumatic drugs or DMARDs in 423 patients who have had an inadequate response to biologics. We expect results from the study later this year.

在類風濕性關節炎方面，I期、II期及III期研究共3項，均已完成全部受試者招募。II 期試驗比較了 filgotinib 與安慰劑，兩者都添加到傳統的疾病修飾抗風濕藥物 (DMARD) 中，用於治療 423 名對生物製劑反應不足的患者。我們預計將於今年稍後獲得該研究結果。

As you know also, our ability to file the NDA for filgotinib is dependent on establishing an adequate safety database, that each dose of the drug being studied as well as data from the MANTA study, which is currently enrolling. We expect results from Phase I, a 52-week randomized study comparing filgotinib plus methotrexate to adalimumab plus methotrexate and to methotrexate alone in patients who have had an inadequate response to methotrexate. And from Phase III, a 52-week randomized study comparing filgotinib alone to methotrexate alone and to the combination of filgotinib plus methotrexate in methotrexate-naïve patients in the first half of next year.

如您所知，我們能否提交 filgotinib 的新藥申請取決於能否建立一個充分的安全資料庫，該資料庫包含正在研究的藥物的每個劑量以及目前正在招募受試者的 MANTA 研究的數據。我們期待 I 期研究的結果，這是一項為期 52 週的隨機研究，比較了 filgotinib 加甲氨蝶呤、阿達木單抗加甲氨蝶呤以及單獨使用甲氨蝶呤治療對甲氨蝶呤反應不足的患者的效果。第三階段，一項為期 52 週的隨機研究將在明年上半年對未接受過甲氨蝶呤治療的患者進行，比較單獨使用 filgotinib、單獨使用甲氨蝶呤以及 filgotinib 加甲氨蝶呤的療效。

In summary, we are very excited about our business performance led by robust HIV revenues, a growing cell therapy franchise, stabilizing dynamics in HCV and a pipeline that will generate multiple Phase III data readouts across our therapeutic areas within the next 12 months.

總而言之，我們對公司業績感到非常興奮，這主要得益於強勁的 HIV 收入、不斷增長的細胞療法業務、穩定的 HCV 業務動態，以及將在未來 12 個月內在我們各個治療領域產生多個 III 期數據結果的研發管線。

I want to take this opportunity to thank John and also Gilead's nearly 11,000 employees for the incredible focus, hard work and execution over the first half of the year.

我想藉此機會感謝約翰以及吉利德公司近 11,000 名員工，感謝他們在今年上半年展現的專注、努力和執行力。

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 Meacham of Barclays.

（操作員說明）我們的第一個問題來自巴克萊銀行的傑夫·米查姆。

John, I just want to say it's been a real pleasure to work with you. You're really going to be missed in the industry.

約翰，我只想說和你一起工作真是太愉快了。你離開後，業內人士都會非常想念你。

Well, thank you, Geoff. I appreciate that.

謝謝你，傑夫。我很感激。

I'm a little worried about payback from our activist letter.

我有點擔心我們那封維權信會遭到報復。

I promise not to write any letters to Barclays.

我保證不會寫任何信給巴克萊銀行。

And I bet you'll miss all of the M&A questions, I'm sure.

我敢肯定，你肯定會錯過所有關於併購的問題。

I will miss this. It's always been a pleasure to work with you guys, and I really enjoyed it over the years. And this is not my last call, so you have one more chance to pester me.

我會想念這裡的。一直以來和你們一起工作都非常愉快，這些年來我真的非常享受和你們一起工作的時光。這不是我最後一次打電話，所以你還有一次機會來煩我。

All right. So when you look at the backdrop, hep C's stable, obviously, HIV is growing, Kite could be a nice platform, do you think -- is Gilead happy to get back to positive growth trends when you look at late this year and definitely in '19? Or is it time to get even more aggressive? I'm just thinking either on deals or maybe more rapid deployment of investments, say, in cell therapy or NASH.

好的。所以從背景來看，丙肝疫情穩定，愛滋病疫情卻在成長，Kite 可能是一個很好的平台，你認為——吉利德公司是否樂於在今年晚些時候，尤其是在 2019 年，恢復積極的成長趨勢？或者，是時候採取更積極的行動了？我只是在考慮交易，或加速投資部署，例如在細胞療法或 NASH 領域。

It's a good question, Geoff. I mean, the message that we're trying to send out here today is that we're very confident in our overall strategy. We are going to continue to be very, very active looking at transactions, which can further our business. And I think it's fair to say, we're never really satisfied with where we are. And we're always seeking to do more faster, and we'll continue to try to do that. And so we have a very active business development team. You'll see many things coming to fruition in the second half of this year. The announcement today is not going to slow us down as the board has given us the go ahead to move with these transactions if they meet our criteria. And so I'm confident in the baseline. I'm never satisfied, and I know my team is not satisfied. And we will continue to move forward. And so that's our message.

傑夫，你問得好。我的意思是，我們今天想要傳達的訊息是，我們對我們的整體策略非常有信心。我們將繼續非常積極地尋找能夠促進我們業務發展的交易機會。而且我認為可以公平地說，我們永遠不會真正對現狀感到滿意。我們一直在尋求更快地完成更多工作，並將繼續努力做到這一點。因此，我們擁有一支非常活躍的業務拓展團隊。今年下半年，你會看到很多事情有成果。今天的公告不會拖慢我們的步伐，因為董事會已經批准，如果這些交易符合我們的標準，我們可以繼續前進。因此，我對基準線很有信心。我永遠不會滿足，我知道我的團隊也不會滿足。我們將繼續前進。這就是我們要傳達的訊息。

Our next question comes from Michael Yee from Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

I think we're all going to echo our appreciation and all the stuff you've done with us, John. And so to that extent, I guess I would ask given perhaps some period of uncertainty, I think, into what that next Gilead is, what do you think investors should anticipate in terms of either new leadership or strategy? Or what do you think could be slightly different? Is that more dealmaking? Is that going into other areas? What do you think would change?

約翰，我想我們都會表達我們對你的感激之情，以及你為我們所做的一切。因此，就此而言，考慮到未來一段時間的不確定性，我認為，對於吉利德的未來發展方向，您認為投資人應該對新的領導階層或策略抱持怎樣的預期？或者你覺得還有哪些地方可以稍作修改？這算是更多交易嗎？這會延伸到其他領域嗎？你認為會有哪些改變？

It's a good question, Michael. If you think about my background and my history, I've been here for a long time from the time the company was a private startup to the $100 billion market cap company we are today, and so I've seen a lot of growth. But I've been pretty limited in my exposure, and I think the next leader should be somebody who brings expertise -- scientific, commercial or other into new opportunities for us to grow. For example, people who've launched products into new markets, such as we're doing NASH or people who really know how to compete in the oncology area where I have less experience. And so I think we are looking for a new leader who will bring new ideas, previous history and experiences we don't have and one who will take the baton from me and move it forward for the company and for the patients we serve. And so I would look for somebody like that.

邁克爾，你問得好。想想我的背景和經歷，我從公司還是一家私人創業公司的時候就在這裡，一直到現在成為市值 1000 億美元的公司，所以我見證了公司的巨大發展。但我接觸到的機會相當有限，我認為下一任領導者應該是能夠將專業知識——無論是科學的、商業的還是其他方面的——帶入新的發展機會的人。例如，那些將產品推向新市場的人，例如我們正在做 NASH 治療的人，或者那些真正了解如何在腫瘤領域競爭的人，而我在這方面經驗較少。因此，我認為我們正在尋找一位新的領導者，他能夠帶來我們所不具備的新理念、歷史和經驗，並能從我手中接過接力棒，帶領公司和我們所服務的患者繼續前進。所以我會尋找這樣的人。

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

下一個問題來自加拿大皇家銀行資本市場的布萊恩亞伯拉罕。

Congrats on the quarter, and, John, my congrats to you as well, on almost 3 decades there and all your accomplishments. On the HIV front, coming out of IAS, just wondering your expectations as to what, if any, impact dual regimens could potentially have on pricing, particularly in Europe and/or overall market share? And then on the housekeeping front, just wondering if you saw any favorable impact from any inventory restocking and HIV revenues this quarter?

恭喜你本季取得佳績，約翰，也恭喜你，你在那裡工作了近30年，並取得了所有成就。關於 HIV 治療方面，我剛參加完 IAS 會議，想了解您對雙重療法可能對定價（尤其是在歐洲）和/或整體市場份額產生何種影響（如果有的話）的預期？另外，關於內部營運方面，想問一下本季庫存補貨和愛滋病相關收入是否產生了任何有利影響？

So maybe I'll start with the last question and then turn it over to Andrew to talk about IAS, Brian. No, the performance in Q2 was demand-driven, and inventory was stable, right. Wholesaler (inaudible) days on hand remained consistent between Q1, Q2. And I'd say again, inventory was commensurate with demand.

那我先回答最後一個問題，然後把麥克風交給安德魯，讓他談談IAS，布萊恩。不，第二季的業績是由需求驅動的，庫存也很穩定，對吧。批發商（聽不清楚）庫存週轉天數在第一季和第二季之間保持穩定。我再次強調，庫存與需求相符。

Yes, Brian, it's Andrew. I think when we look at the GEMINI data come in out of the Amsterdam meeting from yesterday's presentation, I think we've all seen the results. And we still remain interested in better understanding the resistance profile of a 2-drug regimen given some of the methodological differences that we're seeing in patients who have -- may have had virologic failure before week 24 that were excluded from the analysis. I think when we think about looking at the big picture for 2-drug regimens, in particular of dolutegravir and lamivudine, we are interested in understanding what the long-term resistance profile is as highlighted by some of the recent Juluca data that highlighted resistance development past week 48. So we'll be very interested to understand how GEMINI regimens work in the real world and are continuing to focus on its -- the potency in a 2-drug regimen, especially one which has viral load limitations in clinical studies.

是的，布萊恩，我是安德魯。我認為，當我們查看昨天在阿姆斯特丹會議上公佈的 GEMINI 數據時，我們都看到了結果。鑑於我們在一些患者中觀察到的方法學差異（這些患者可能在第 24 週之前出現病毒學失敗，因此被排除在分析之外），我們仍然有興趣更好地了解雙藥方案的抗藥性特徵。我認為，當我們考慮雙藥療法（特別是多替拉韋和拉米夫定）的大局時，我們感興趣的是了解長期抗藥性概況，正如最近的 Juluca 數據所強調的那樣，抗藥性在第 48 週之後開始出現。因此，我們將非常有興趣了解 GEMINI 療法在現實世界中的作用，並將繼續關注其——雙藥療法的效力，尤其是在臨床研究中存在病毒載量限制的療法。

Our next question comes from Geoffrey Porges of Leerink.

我們的下一個問題來自 Leerink 公司的 Geoffrey Porges。

I echo the congratulations, John. I'd like to be the first to volunteer over the next 6 months to help teach you how to prepare a resume since it's apparent that you've never prepared one before.

約翰，我也向你表示祝賀。在接下來的六個月裡，我願意第一個自願幫助你學習如何準備履歷，因為很明顯你以前從未準備過履歷。

Don't worry, my daughter told me she's going to teach me how to set up a LinkedIn profile.

別擔心，我女兒說她要教我如何建立 LinkedIn 個人資料。

I look forward to that. I guess the business is really stunning. It really started out in HIV, and now it's come full circle. It's really very much focused on HIV now, but with just a much broader and remarkable product portfolio. So I'd like to hear you comment about what the sustainable growth rate is for the HIV business, at least through 2022 or so. You're in the transition from the legacy combinations over to the TAF-based combinations. Biktarvy's just doing fabulously well. And it's difficult for us to sort of model exactly how that shift occurs. But what should we be thinking about the sustainable growth rate for this business and the contribution from volume, price and mix of both currently and then going forward?

我期待著那一天的到來。我覺得這家公司真的很了不起。這一切最初源自於愛滋病，現在又回到了原點。現在它確實非常專注於愛滋病毒，但擁有更廣泛、更卓越的產品組合。所以我想聽聽您對愛滋病業務可持續成長率的看法，至少到 2022 年左右。您正處於從傳統組合過渡到基於 TAF 的組合的階段。Biktarvy 的表現簡直棒極了。我們很難準確地模擬這種轉變是如何發生的。但是，對於該業務的可持續成長率，以及目前和未來銷售、價格和兩者組合的貢獻，我們應該如何思考？

Okay. Geoff, I don't know how I'll start out with this. I mean, I think beyond -- you mentioned 2022, but we see this as a growing franchise well beyond 2022. And we think that the TAF-based regimens will be the drug of -- the backbone of choice for patients. We think Biktarvy will be a very, very large, successful product, and we see great opportunities for a number of areas to treat more patients. There's still aren't all patients in the United States who are under treatment. And with the simplification, we continue to think that we can expand the number of patients who will be treated across the United States. I think Andrew mentioned we're making great progress in our long-acting products. I think there's a significant segment of patients who aren't treated today who would choose an every 3-month option. We're very, very encouraged by the pharmacokinetic data we're seeing for this molecule. It is a very interesting opportunity for us to grow the field beyond the 750,000 patients treated in the United States to a much higher number. And so I see great opportunities for us to extend it and expand the range of that. And I'll turn it over to Robin for her thoughts.

好的。傑夫，我不知道該如何開始。我的意思是，我認為它的發展遠不止於——你提到了 2022 年，但我們認為這是一個不斷發展的系列，其影響力遠遠超過 2022 年。我們認為，以 TAF 為基礎的治療方案將成為患者的首選藥物—治療方案的骨幹。我們認為 Biktarvy 將會是一款非常非常成功的產品，我們看到它在許多領域都有很大的應用前景，可以為更多患者提供治療。目前美國仍有一些患者正在接受治療。透過簡化流程，我們仍然認為我們可以擴大全美接受治療的患者人數。我想安德魯提到過，我們在長效產品方面取得了巨大進展。我認為目前有相當一部分未接受治療的患者會選擇每三個月接受一次治療的方案。我們對這種分子的藥物動力學數據感到非常鼓舞。對我們來說，這是一個非常有趣的機會，可以將該領域的患者人數從美國目前的 75 萬增加到更高的數字。因此，我認為我們有很大的機會去擴展它，並擴大它的範圍。接下來我會把話題交給羅賓，聽聽她的看法。

I think you've covered it, John. And Geoff, as you've seen relative to the conversion of Descovy-based products, that's been very -- a very good surge, over 70% in the U.S., 60% in EU and as John said, Andrew and team are continuing to go forth with new innovation and new development. So we're very confident in our ability to continue to grow this franchise, even through long-term LOEs. I think innovation and HIV -- innovation of HIV is Gilead and that will stay true to what we will always -- I think, we excel at.

約翰，我覺得你已經講清楚了。傑夫，正如你所看到的，基於 Descovy 的產品轉換率非常高，在美國成長了 70% 以上，在歐盟成長了 60% 以上。正如約翰所說，安德魯和他的團隊正在繼續推動新的創新和開發。因此，我們非常有信心能夠繼續發展這項業務，即使是透過長期的合約終止。我認為創新和愛滋病——愛滋病領域的創新是吉利德的專長，我們將始終堅持我們擅長的領域——我認為，我們在這方面做得非常出色。

Geoff, it's Andrew. I would just only add that when one thinks about the growth rate, one really has to factor the 250,000 to 300,000 Americans who know that they're living with HIV, yet are not receiving any form of antiretroviral therapy. And so there are many reasons for that there, but one of them is that, as I highlighted, the oral therapies may not work for their -- where they are in their life at this point. But as we know, HIV progresses without (inaudible) control. And so the capsid is something we're very, very excited about given its profile. In addition, when we think about Biktarvy, I think we -- just adding some color to what we've seen to date is that we've seen Biktarvy open doors for us that really we haven't seen. Multiple examples of doctors or practices that have been closed to us for more than 5 years, that with the profile that we've seen with Biktarvy, no resistance as well as once-daily, (inaudible) small tablets plus well-tolerated, unboosted integrase inhibitors with few drug interactions that has really made a difference in how physicians and patients look at this compound. And we've also seen institutions create therapeutic exceptions for Biktarvy to enter their institutions because of its profile.

傑夫，我是安德魯。我只想補充一點，在考慮成長率時，必須考慮到有 25 萬到 30 萬美國人知道自己感染了 HIV，但卻沒有接受任何形式的抗病毒治療。因此，這其中有很多原因，但其中一個原因是，正如我所強調的那樣，口服療法可能對他們——在他們目前的人生階段——不起作用。但我們知道，愛滋病毒的傳播是不受控制的。鑑於其特性，我們對衣殼感到非常非常興奮。此外，當我們想到 Biktarvy 時，我認為——只是想為我們迄今為止所看到的增添一些色彩——我們看到 Biktarvy 為我們打開了我們以前從未見過的大門。許多醫生或診所已經對我們關閉了 5 年多，但我們看到 Biktarvy 的特性，例如無抗藥性、每日一次的小藥片、耐受性良好、未增強的整合酶抑製劑以及很少的藥物相互作用，確實改變了醫生和患者對這種化合物的看法。我們也看到一些機構因為 Biktarvy 的特殊性，為它制定了治療例外條款，允許它進入這些機構。

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。

So John, congratulations to you and good luck as you take a well-deserved break. I'd like to ask a sort of product-specific question, if I could. So -- and maybe this is for Andrew, but can you just comment on how you did resistance testing in your studies versus the method that they've employed in their studies? And if there are any key differences in that, that may have led to sort of lack of seeing some resistant mutants if they were occurring?

約翰，恭喜你，祝你好好享受這來之不易的假期。如果可以的話，我想問一個與產品相關的問題。所以——也許這個問題是問安德魯的，你能否評論一下你在研究中是如何進行電阻測試的，以及他們在研究中採用的方法有何不同？如果這方面有任何關鍵差異，是否會導致我們未能發現某些抗性突變體（如果它們確實存在的話）？

So Matthew, thank you for the very good question, it's a very technical one. But I think on -- when it came to resistant samples, we began looking at resistant samples at week 8. And with an integration (inaudible), they come down quite rapidly. We did not look -- require patients to discontinue for them to be, what we call, our resistance analysis population. So anyone with a viral load after they suppress -- of greater than 50, we put into our resistance analysis population. So we looked at them and we used the second sample to quantify whether or not -- because the first patient would come in, they had a higher -- greater than 50 viral load and we would proceed to get the second confirmatory sample and send that off for analysis.

馬修，謝謝你提出的好問題，這確實是一個非常技術性的問題。但我認為——就抗藥性樣本而言，我們從第 8 週開始觀察抗藥性樣本。隨著整合（聽不清楚），它們下降得相當快。我們沒有要求患者停止治療，這樣他們就成為我們所謂的抗藥性分析族群。因此，任何病毒量在抑制後大於 50 的人，我們都將其納入抗藥性分析族群。所以我們觀察了這些樣本，並使用第二個樣本來量化——因為當第一個病人進來時，他們的病毒量較高——大於 50，我們會繼續獲取第二個確認樣本並將其送去分析。

And I think it's fair to say that's a very, very rigorous analysis to really make sure that there's no resistance.

我認為可以公平地說，這是一個非常非常嚴謹的分析，旨在確保沒有阻力。

Yes, right. John, I think that's right. And I think we're very comfortable with the strong resistance profile of Biktarvy. And as you know, we're -- it's -- we're very close to presenting 96-week data in upcoming scientific conference.

沒錯。約翰，我覺得你說得對。我認為我們對 Biktarvy 的強抗性特性非常有信心。如您所知，我們即將在即將召開的科學會議上公佈 96 週的數據。

And our next question comes from Robyn Karnauskas of Citi.

下一個問題來自花旗銀行的 Robyn Karnauskas。

And John, I just want to echo what everyone else had said. It's been a pleasure working with you and learning from you. I guess the question I have is really around NASH. That -- it's gone from, this is a massive market, to, it's not a market, to, oh, now it's a market again. Maybe since you're going into the phase of hiring people who can (inaudible), can you give us some sense on how you're thinking about what you're learning about the market as it's developing and what you're hearing from what doctors once you see in the space and how you think it'll evolve with your data and the coming data over the next year? And then on -- a part of that would be on M&A. Are you thinking about -- do you think you have enough drugs in development? Or would you think about adding to the pipeline because there's a lot of other NASH drugs out there as well?

約翰，我只想重複其他人說過的話。與您共事並向您學習，我感到非常榮幸。我想問的問題其實是關於非酒精性脂肪性肝炎（NASH）的。情況就是這樣——從“這是一個巨大的市場”，變成了“這不是一個市場”，然後又變成了“哦，現在它又是一個市場”。既然你們即將進入招募能夠（聽不清楚）的人員的階段，能否請你們談談你們是如何看待你們對市場發展現狀的了解，以及你們從醫生那裡聽到的反饋，還有你們認為在未來一年裡，隨著你們的數據和即將獲得的數據，市場將如何發展？然後，其中一部分將涉及併購。你在想──你認為你們在研發的藥物夠用嗎？或是您會考慮增加研發管線嗎？因為市面上還有很多其他治療非酒精性脂肪性肝炎的藥物？

Well, first of all, thank you, Robyn, for those kind words. And I'm not sure that I ever thought NASH wasn't a market. I think we've done a lot of digging. We've been doing a lot of early market development work around NASH, understanding the doctors, the populations, the kinds of diagnostic tests that will be necessary across the different fibrosis scores, trying to really understand what is the best, right medical way to get into this area because we're going to have to establish the market. I think we are likely to be the first drug launched into NASH. So I think we've got a pretty good understanding of the patients. We have a pretty good understanding of the differing opportunities for the F2 through F4 populations. So it -- I think it has a considerable potential to be a big market for the field and for us. And so I think we're pretty confident in that area. You asked about M&A. Do we have enough molecules? I would say we never feel like we have enough molecules in any area, which is why we continue to innovate in HIV for more than 2 decades and why we'll continue to look for things that make sense in combination with or adjacent to our portfolio in NASH. So I -- we're kind of relentless in that area.

首先，謝謝羅賓的鼓勵與讚揚。我不確定我是否曾經認為 NASH 不是一個市場。我認為我們已經做了很多調查工作。我們一直在圍繞 NASH 進行大量的早期市場開發工作，了解醫生、人群、不同纖維化評分所需的診斷測試類型，努力真正了解進入這個領域的最佳、正確的醫療方法是什麼，因為我們必須建立市場。我認為我們很可能成為首個推出用於治療非酒精性脂肪性肝炎的藥物。所以我覺得我們對患者的狀況已經有相當不錯的了解。我們對 F2 至 F4 代群體所面臨的不同機會有了相當清晰的了解。所以——我認為它有相當大的潛力成為該領域和我們公司的大市場。所以我覺得我們在這方面相當有信心。你問到了併購方面的問題。我們有足夠的分子嗎？我認為我們永遠不會覺得我們在任何領域擁有足夠的分子，這就是為什麼我們在 HIV 領域持續創新超過 20 年，也是為什麼我們將繼續尋找與我們在 NASH 領域的產品組合結合或相鄰的有意義的東西。所以，我們在這個領域可以說是鈸而不捨的。

And our next question comes from Umer Raffat of Evercore.

我們的下一個問題來自 Evercore 公司的 Umer Raffat。

I want to focus both -- on 2 things. One, for the ongoing Phase III NASH studies, is there an interim of sorts that we should be aware of before the final readouts, first? And then secondly, is there anything we have learned on a blinded basis from the ongoing filgotinib testicular tox studies?

我想同時關注兩件事。第一，對於正在進行的 III 期 NASH 研究，在最終結果公佈之前，是否有我們應該了解的某種中期結果？其次，從正在進行的 filgotinib 睪丸毒性研究中，我們是否從盲法研究中了解了什麼？

Okay. So it's John speaking, and I'll address. In terms of the Phase III STELLAR trials in NASH, there is no interim analysis. The interim analysis is actually the end point -- one of the interim analysis is the end point for approval on the subpart H, which is the week 48 biopsy. The study actually continues for 5 years. We do have a DMC, of course, that looks at all the safety data regularly. So if there's any obvious safety signal, the risk benefit change, we would know about that. And so far, we've not had any recommendations to change either of those Phase III studies in terms of their conduct. In terms of filgotinib and the male safety study, we're enrolling the study. It's something that we have to address. We believe our margin is adequate, above and beyond the minor histological abnormalities that we're seeing in the preclinical models, and we'll evaluate the data as it comes in.

好的。我是約翰，接下來我將發言。就 NASH 的 III 期 STELLAR 試驗而言，目前尚無中期分析。中期分析實際上是終點—​​—其中一項中期分析是 H 子部分批准的終點，即第 48 週活檢。這項研究實際上持續了5年。當然，我們有一個資料管理委員會（DMC），會定期審查所有安全資料。所以，如果出現任何明顯的安全訊號，風險效益發生變化，我們就會知道。到目前為止，我們還沒有收到任何關於改變這兩項 III 期研究進行方式的建議。關於 filgotinib 和男性安全性研究，我們正在招募受試者。這是我們必須解決的問題。我們認為我們的安全邊際足夠，遠超我們在臨床前模型中觀察到的輕微組織學異常，我們將根據後續數據進行評估。

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

下一個問題來自富國銀行的吉姆·伯奇諾夫。

It's Nick in for Jim. And John, I'm sure Jim will echo my comments thanking you for your candor and transparency over the years. I have a very specific question that is relating to the deal you did last week. Is your concept here that you're going to be adding in the gamma delta T-cell receptors to CAR T or TCRs to give you that sort of [buy] specific or do you see this as a stand-alone or an additional product?

尼克代替吉姆上場。約翰，我相信吉姆也會贊同我的看法，感謝你多年來的坦誠和透明。我有一個非常具體的問題，與你上週完成的交易有關。你的想法是把γδT細胞受體加入CAR T或TCR中，以獲得某種特定的[購買]效果，還是你認為這是一個獨立的產品或附加產品？

Yes, that's a great question, Nick. I think it was [we called] your name. So we believe that it is a stand-alone. We believe that the gamma data TCR constructed or engineered into the alpha beta T cell will have all of the advantages of both -- properties of both of those cells, which will allow us to explore them individually in terms of both hematological and also solid malignancies. So that's a very short answer to a very complex question, but that will be our initial approach, and that is the initial program that we'll collaborate on.

是的，尼克，你問得好。我想我們喊的是你的名字。所以我們認為它是一個獨立的系統。我們相信，建構或改造到αβT細胞中的γ數據TCR將兼具這兩種細胞的所有優點——這兩種細胞的特性，這將使我們能夠分別從血液惡性腫瘤和實體惡性腫瘤的角度來研究它們。所以，對於一個非常複雜的問題，這是一個非常簡短的回答，但這將是我們的初步方法，也是我們將要合作的初步方案。

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

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

John, let me add my congratulations on a fantastic career that's played a big part in the success of Gilead and in strides in the treatment of HIV and HCV. Definitely a job well done. Two questions. First, on your pipeline, there's an entry in the slides that says the Kite 585 program. We're going to have Phase I data in the back half of the year and also a go decision on -- a go, no go decision on a pivotal study. Can you give us some idea of what data we're likely to see and what the hurdle would be to moving into pivotals? And if I could just sneak in a question on the commercial briefly. Robin, I think you mentioned that the HIV payer mix was different in Q2 than in the past. What drove that? And is that likely to revert to the normal payer mix in the second half of the year?

約翰，請容許我向你表示祝賀，你擁有了輝煌的職業生涯，為吉利德的成功以及愛滋病和丙型肝炎治療的進步做出了巨大貢獻。絕對乾得漂亮。兩個問題。首先，在你的流程中，投影片裡有一筆記錄，寫著 Kite 585 程式。我們將在今年下半年獲得 I 期數據，並就一項關鍵研究做出是否開展的決定。您能否大致介紹一下我們可能會看到哪些數據，以及進入關鍵階段的障礙是什麼？我能否就這則廣告問一個問題？羅賓，我想你提到過，第二季度愛滋病毒感染者的支付方組成與以往有所不同。是什麼原因導致這種情況？下半年，這種支付方構成是否有可能恢復正常？

Okay. So Phil, it's John, and I will talk about the 585 program first, which is in Phase I. It's those escalations, as you know, in people with relapsed/refractory myeloma. So we will see data, as we've said on the slides, in the second half of this year and then we'll make a decision depending on how the data looks compared to the other data that's come out from other similar BCMA products and determine whether we will take it forward into Phase II, and that's where we are right now. But we see the value in exploring it in patients with relapsed/refractory myeloma, of course. We have cohorts of people with renal impairments as well, which is also important. Many of these people have renal impairments, so we will also be looking at that as well. And we have a lot of support from the community. We have a single-chain variable fragment that's fully humanized, as you know. And we have activity in low BCMA-expressing targets as well. So we'll have just to wait and see where the Phase I data is, and we'll make a decision later this year about moving onto the more registrational trial.

好的。菲爾，我是約翰，我先來談談 585 項目，它目前處於 I 期。如你所知，它是針對復發/難治性多發性骨髓瘤患者的劑量遞增治療方案。正如我們在幻燈片中所說，我們將在今年下半年看到數據，然後我們將根據這些數據與其他類似BCMA產品的數據進行比較，來決定是否將其推進到II期臨床試驗，這就是我們目前所處的階段。當然，我們認為探索這種方法對復發/難治性多發性骨髓瘤患者是有價值的。我們還有一些腎功能受損的人群，這也很重要。這些人中很多都有腎功能障礙，所以我們也會注意這方面的狀況。我們得到了社區的大力支持。如您所知，我們有一個完全人源化的單鏈可變片段。我們在低 BCMA 表現靶點也具有活性。所以，我們只能等待第一階段的數據結果，並在今年稍後決定是否要進入註冊試驗階段。

And our next question comes from...

我們的下一個問題來自…

Well, actually...

嗯，其實…

Let me just finish, operator. I think Phil asked one question regarding payer mix in HIV for Q2 that I want to be sure I address. And so to be specific, you're right, you'll recall that if you think about our HIV franchise, it's typically slanted more to the government payer mix driven by the ADAPs and that's been fairly consistent. There's always a little variability here and there. But overall, when you think about it, it's typically a mix of 45% commercial and 55% government. In Q2, we saw that mix more equal, i.e. 50-50. So what I was messaging is if you think about the second half as that normalizes, we quantified it to be approximately about $150 million. It's always tough to be exact because it's really based on some reimbursements and [remakes] that come in typically after a quarter ends, so we're always estimating. But we just wanted to be cautious and transparent that if that shifts back to what we normally see, it could be a slight headwind relative to sequential growth for U.S. HIV. Overall, robust growth year-on-year. It's simply an adjustment between quarters, but very much factored into our guidance. And again, it's just a slightly larger tilt relative to that mix than we've typically seen in the past.

讓我先說完，接線生。我認為菲爾就第二季度愛滋病治療的支付方組成提出了一個問題，我想確保我能回答這個問題。具體來說，你說得對，你會記得，如果你想想我們的 HIV 專項資金，它通常更傾向於由 ADAP 推動的政府支付方組合，而且這種情況一直相當穩定。總是會有一些細微的差別。但總的來說，仔細想想，通常是 45% 的商業活動和 55% 的政府活動混合在一起。在第二季度，我們看到混合比例更加均衡，即五五開。所以我想表達的是，如果你把下半年的情況看作是正常的，我們估計它大約是 1.5 億美元。很難做到準確，因為這實際上是基於一些補償和[重拍]，這些通常在季度結束後才會到賬，所以我們總是在估算。但我們只是想謹慎且透明地說明，如果這種情況恢復到我們通常看到的水平，可能會對美國 HIV 的連續增長造成輕微的不利影響。整體而言，年成長強勁。這只是季度間的調整，但已充分納入我們的業績指引。而且，與過去我們通常看到的相比，這種比例略微偏大一些。

And our next question comes from Tyler Van Buren of Piper Jaffray.

下一個問題來自 Piper Jaffray 公司的 Tyler Van Buren。

It sounds like -- I want to ask a question on the cellular therapy business and some of the progress that has been made as of late. Sounds like you guys are pretty adequately penetrated in the center. So could you just provide an update on some of the logistics and some of the improvements that have been made as of late? I know there's some debate over whether freezing the product is beneficial or not and paying on demand as opposed to having to pay up front prior to receiving a product and things like that. So curious to get your thoughts.

聽起來——我想問一個關於細胞療法行業以及近期取得的一些進展的問題。聽起來你們的中心位置已經被徹底滲透了。能否簡單介紹一下物流方面的一些進展以及近期所做的一些改進？我知道對於冷凍產品是否有利，以及按需付款與在收到產品之前預付款等問題，存在一些爭議。很想聽聽你的想法。

So it was John?

所以是約翰？

Tyler.

泰勒。

Tyler, right. Tyler, maybe I'll start, but I think we can all chime in. Yes. I mean, we're -- we are -- overall, are very excited relative to our progress of the Yescarta launch. Our centers, as I mentioned, are on track relative to our coverage. We're focused on bringing additional centers online. And similar to what you said, we're really focused on improving the patient flows and just being sure that our centers are focused on -- or our manufacturing process continue to be excellent and we have good turnaround times. I'd say overall that our commercial performance has been generally consistent with what we've seen in the ZUMA-1 studies. So we're very confident, making good progress. Remember we've talked about this being a nice, slow and steady launch. I talked on the -- in my prepared remarks about us focused on reimbursement. So overall, a very good launch and very -- tracking very good relative to expectations. And I'll turn it over to John to talk about some of the other issues you mentioned.

泰勒，右邊。泰勒，或許我可以先說，但我覺得我們大家都可以參與討論。是的。我的意思是，總的來說，我們對 Yescarta 的發布進展感到非常興奮。正如我之前提到的，我們的中心目前正按計劃推進，以達到我們的覆蓋目標。我們正致力於讓更多中心上線。正如你所說，我們確實非常注重改善患者就診流程，並確保我們的中心專注於——或者說，我們的生產流程繼續保持卓越，並且我們有良好的周轉時間。總的來說，我認為我們的商業表現與我們在 ZUMA-1 研究中看到的結果基本一致。所以我們非常有信心，進展順利。記住我們之前說過，這將是一個平穩、緩慢而穩定的發布過程。我在事先準備好的演講稿中談到了——我們重點關注的是報銷問題。總的來說，發布非常成功，而且追蹤結果也遠遠超出預期。接下來我將把發言權交給約翰，讓他談談你提到的其他一些問題。

Tyler, I don't think -- we have an exceptional group of scientists who spend a lot of time thinking about manufacturing process and how it can be improved for the product, more active, greater efficacy, safer and so forth. So as Robin said, I'll just reiterate, I mean, what we've seen in ZUMA-1 is what we're seeing in clinical practice as well, and we're not having lots of -- lot of out-of-specification issues, et cetera. So in terms of freezing products or not freezing products, we -- that's not really an issue for this. Products can be frozen, if they need to -- if the cells need to be collected and shipped and sent a long distance to somebody that's very remote, a product could be frozen, it would take an additional day to do.

泰勒，我不這麼認為——我們擁有一支傑出的科學家團隊，他們花費大量時間思考生產過程以及如何改進生產過程，使產品更具活性、更有效、更安全等等。正如 Robin 所說，我再重申一遍，我的意思是，我們在 ZUMA-1 中看到的情況，也是我們在臨床實踐中看到的情況，我們沒有遇到很多——很多不符合規範的問題等等。所以就冷凍產品還是不冷凍產品而言，我們——這並不是一個真正的問題。如果需要，產品可以冷凍——如果需要收集細胞並長途運送到非常偏遠的地方，產品可以冷凍，但這會額外花費一天的時間。

Yes, for -- that's a good point, John. For example, our -- for our European patients, we'll freeze the cells and send them in. So it's not our practice in the United States, but it is certainly possible. We have quite a bit of experience doing that. I think you said something about payment on demand, I just want to reiterate that we take on the cells, we manufacture them and we only charge the patient if that patient gets those cells. So if something happens in the interim, for example, the patient expires, then there is no charge to the family.

是的，因為──你說得對，約翰。例如，對於我們的歐洲患者，我們會將細胞冷凍起來並寄送過去。所以這在美國不是我們的做法，但這當然是有可能的。我們在這方面有很多經驗。我想你剛才提到了按需付款，我只想重申一下，我們接收細胞，我們生產細胞，只有當患者接受這些細胞時，我們才會向患者收費。因此，如果在此期間發生什麼事，例如病人去世，那麼家屬無需支付任何費用。

And our next question comes from Cory Kasimov of JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

Let me also add my congratulations to John on a great run. You'll definitely be missed. Want to follow up on the CAR T front. And although it's obviously very early in the launch, curious about any comments or color you can provide in terms of safety, CRS or neurotox rates that you're seeing in kind of the real-world experience and relative to what you saw in the clinical trials. And I'm curious more specifically on whether in the commercial setting, these rates have changed at all been, have been appreciably different for patients based on the receipt of bridging chemotherapy.

我還要祝賀約翰跑得非常出色。你一定會被人想念的。想跟進一下 CAR-T 的相關情況。雖然現在顯然還處於產品上市的早期階段，但我很想知道您在實際使用中觀察到的安全性、細胞因子釋放綜合徵 (CRS) 或神經毒性發生率方面，能否提供一些評論或見解，並與臨床試驗中觀察到的情況進行比較。我更想知道的是，在商業環境中，這些費率是否發生了變化，或者對於接受橋接化療的患者來說，這些費率是否明顯不同。

Cory, it's John McHutchison. And we actually have scientific advisory board here in all of our Kite development talks. We're here and we were talking about this, and I actually asked them this specific question as to whether they're seeing anything different with the commercial product and so forth, and there isn't a difference.

科里，我是約翰‧麥克哈奇森。事實上，我們所有的風箏開發討論中都設有科學顧問委員會。我們現在就在這裡，我們一直在討論這個問題，我還特別問了他們這個問題，即他們是否發現商業產品有什麼不同等等，他們的回答是沒有不同。

And our next question comes from Katherine Xu of William Blair.

下一個問題來自威廉布萊爾大學的凱瑟琳徐。

John, my congratulations to you as well for great achievements at Gilead and also all the best to you on the next phase of career and life. A very quick question on the HCV side. So the international sales have been growing. I just want to understand where that growth has come from and how the launch in China is going. And also on the HBV front, B as in boy, what is Gilead's grand strategy there?

約翰，我也要祝賀你在吉利德公司取得的巨大成就，並祝福你在職涯和人生的下一個階段一切順利。關於丙型肝炎方面，我有一個非常簡短的問題。因此，國際銷售額一直在成長。我只是想了解這種成長來自哪裡，以及在中國的上市情況如何。還有，關於B型肝炎病毒（HBV），基利德公司（Gilead）的宏偉策略是什麼？

So maybe, Katherine, I'll take the HBV question. We're excited. I mean, Epclusa was recently approved in China. I think it's still very early days there, but we're excited about the possibilities outside of Europe and the U.S. We've got also international sales in Japan, Canada, Australia as well as several countries in Asia. And while there are quarterly fluctuations from country to country, I think overall, we continue to establish ourselves in those markets similar to what we have done in the U.S. and Europe. So as you can see, overall, we're on track with our guidance, more stability and predictability. And I think with Epclusa, right, which is the only pan-genotypic, pan-fibrotic, single-tablet regimen out there, I think we're well poised with our portfolio of products to be successful globally with our HBV franchise.

那麼，凱瑟琳，或許我可以回答關於B型肝炎病毒的問題。我們很興奮。我的意思是，Epclusa 最近在中國獲得了批准。我認為現在還處於非常早期的階段，但我們對歐洲和美國以外的市場前景感到興奮。我們在日本、加拿大、澳洲以及亞洲幾個國家也有國際銷售業務。雖然各國之間存在季度波動，但我認為總體而言，我們繼續在這些市場站穩腳跟，就像我們在美國和歐洲所做的那樣。所以正如你所看到的，總體而言，我們正朝著既定目標穩步前進，更加穩定和可預測。我認為，憑藉 Epclusa（目前唯一一種泛基因型、泛纖維化單片療法），我們的產品組合讓我們在乙肝產品領域具備了在全球範圍內取得成功的良好基礎。

Yes.

是的。

Katherine, it's John again. And just a follow-up from Robin, before I answer the hepatitis B strategy question. Epclusa is the simplest regimen to use. It's one duration, as Robin said. You don't need a liver biopsy. You don't need to genotype. So in terms of all the products out there, it's far simpler. And the efficacy is the same as some of the others as you know. So there's no compromise there. In terms of the grand strategy for hepatitis B, I think it's similar to your notes. We want to be able to attack multiple different mechanisms of viral replication, and we want to be able to augment HBV-specific immunity. We have 2 new programs in the clinic, one is a TLR8 molecule and the other one is our capsid, also that's in early stages in the clinic. We have our SB 9200, Spring Bank 9200 collaboration in 2 Phase II trials, one with tenofovir and one with TAF. We have many great clinical programs, looking at other mechanisms of action also in both of those [axises]. And of course, we have Vemlidy, which is approved and doesn't have any issues with bone or kidneys, as you know, in more than 50 countries. So it's one of our largest internal research programs, and we're passionate about trying to create a finite cure for many people -- many millions of people with hepatitis B around the world.

凱瑟琳，又是約翰。在我回答B肝策略問題之前，Robin還有一個後續問題。Epclusa 是使用起來最簡單的治療方案。正如羅賓所說，時長只有一個。你不需要做肝臟切片檢查。你不需要進行基因分型。所以就目前市面上的所有產品而言，這要簡單得多。如你所知，它的功效與其他一些產品相同。所以這個問題沒有妥協的空間。就乙肝的整體策略而言，我認為與你的筆記類似。我們希望能夠攻擊多種不同的病毒複製機制，我們希望能夠增強對B型肝炎病毒的特異性免疫力。我們目前有兩個新項目正在臨床上進行，一個是 TLR8 分子，另一個是我們的衣殼，這兩個項目也處於臨床早期階段。我們與 SB 9200 和 Spring Bank 9200 合作開展了 2 項 II 期試驗，一項與替諾福韋聯合，一項與 TAF 聯合。我們有很多優秀的臨床項目，也在研究這兩個[軸]中的其他作用機制。當然，我們還有 Vemlidy，它已獲得批准，並且如您所知，在 50 多個國家/地區使用，不會對骨骼或腎臟造成任何問題。因此，這是我們最大的內部研究計畫之一，我們熱衷於為許多人——全世界數百萬B肝患者——創造一種有效的治療方法。

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

最後一個問題來自美國銀行美林證券的黃穎女士。

One for, maybe, Robin. You actually saw a very decent increase in Q2 revenue compared to 1Q, but you did not increase the guidance for the total product sales for the whole year. I wanted to drill down a little bit more why that is? And then secondly, maybe for John McHutchison. You mentioned that the filing of FDA application for [filgotinib] has to wait until you finish the sub safety study in the UC trial, which won't complete enrollment until first half '19. Does that mean we have to wait until at least second half of next year before you can file for NDA for filgotinib?

或許，這是給羅賓的。與第一季相比，第二季營收確實有了相當可觀的成長，但你們並沒有提高全年產品總銷售額的預期。我想更深入地探究一下這是為什麼？其次，或許是為了約翰‧麥克哈奇森。您提到，[filgotinib] 的 FDA 申請必須等到您完成 UC 試驗的子安全性研究後才能提交，而該試驗要到 2019 年上半年才能完成入組。那是不是代表我們至少要等到明年下半年才能提交filgotinib的新藥申請？

Sure, Ying. So I'll start. Again, as I mentioned on the call, I think our HIV franchise is firing on all cylinders. It's positioned extremely well to deliver on long-term growth. And what we were -- what I -- when I think about guidance, again, we reiterated our guidance and feel very comfortable with it. But as I mentioned on the call, we do anticipate second half dynamics to be slightly different. So there's nothing new about those dynamics, but we did want to ensure that you understood for modeling purposes kind of some of those components. And as I said, for HIV, in the U.S., we may have payer mix shift more to what normally occurs. But other than that, things are very good there. We do have a patent for Letairis in the U.S., which expires at the end of July, so we do anticipate some impact from generics for that product in the U.S. Turning to Europe, generics are available, and we do expect them to become available in a few additional countries. And we have the normal third quarter seasonality in Europe related to summer holidays, and that impacts both our HIV as well as our HCV franchise. And we also have the slow, steady decline of HCV patient starts. So I do want to emphasize that we expect our U.S. HIV prescription growth and revenue growth on a year-on-year basis to continue to be very, very healthy and robust, but we're reiterating our guidance because all those factors that we talked about at the beginning of the year still remain.

當然可以，瑩。那我先來。正如我在電話會議中提到的，我認為我們的愛滋病防治業務正在全面運作。它具備實現長期成長的絕佳優勢。而我們——我——當我想到指導時，我們再次重申了我們的指導，並且對此感到非常滿意。但正如我在電話會議中提到的，我們預計下半年的情況會略有不同。所以這些動態並沒有什麼新意，但我們確實想確保您出於建模的目的理解其中的一些組成部分。正如我所說，在美國，對於愛滋病毒，我們的支付方結構可能會更多地向正常情況轉變。但除此之外，那裡的一切都很好。我們在美國擁有 Letairis 的專利，該專利將於 7 月底到期，因此我們預計該產品在美國將受到仿製藥的影響。至於歐洲，仿製藥已經上市，我們預計它們也會在其他一些國家上市。歐洲第三季的季節性波動與夏季假期有關，這會對我們的 HIV 和 HCV 產品線產生影響。同時，丙型肝炎患者數量也在緩慢、穩定地下降。因此，我想強調的是，我們預計美國 HIV 處方增長和收入同比增長將繼續保持非常非常健康強勁的勢頭，但我們重申我們的預期，因為我們年初討論的所有因素仍然存在。

Ying, for the second part of the question, in terms of the filgotinib filing time, obviously, we'll file as expeditiously as we can. But just let me just make 3 points. First of all, we need safety and efficacy data from 3 randomized Phase III trials, and that has to be supportive. Secondly, we need an -- as I said today on the prepared comments, we need an adequate safety database in terms of exposure in each stage, so it's for a predetermined range of time. And thirdly, we need to submit data from the male safety study, which is enrolling. And there -- these are tough studies to do. You've got to have men with ulcerative colitis and they have to be on the drug for 6 months and have multiple sperm collection. So we're doing everything we can to enhance enrollment, and we will announce the details when it's appropriate in terms of the filing time.

穎，關於問題的第二部分，也就是filgotinib的申請時間，顯然，我們會盡快提交申請。但請容許我提出三點。首先，我們需要 3 項隨機 III 期試驗的安全性和有效性數據，而這些數據必須能夠提供支持。其次，正如我今天在準備好的評論中所說，我們需要一個足夠的安全資料庫，記錄每個階段的暴露情況，以便在預定的時間範圍內進行評估。第三，我們需要提交男性安全研究的數據，研究正在招募受試者。而且，這些都是很難進行的研究。必須找到患有潰瘍性結腸炎的男性，他們必須服用該藥物 6 個月，並進行多次精液採集。因此，我們正在盡一切努力提高入學率，我們將在適當的時機公佈報名時間等細節。

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

今天的問答環節到此結束。我謹將會議交還給李成先生，請他作總結發言。

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

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

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

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