吉利德科學 (GILD) 2019 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences' Third Quarter 2019 Earnings Conference Call. My name is Liz, and I will be your conference operator today. (Operator Instructions) And as a reminder, this conference call is being recorded.

女士們、先生們，感謝各位的耐心等待，歡迎參加吉利德科學公司2019年第三季財報電話會議。我叫莉茲，今天我將擔任你們的會議接線生。（操作員說明）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, Senior Vice President of Investor Relations. Please go ahead.

現在我將把電話交給投資人關係資深副總裁李成先生。請繼續。

Thank you, Liz, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the third quarter 2019. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

謝謝你，莉茲，大家午安。今天股市收盤後不久，我們發布了 2019 年第三季獲利結果的新聞稿。新聞稿和詳細幻燈片可在吉利德公司網站的投資者關係部分查看。

The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; and Johanna Mercier, Chief Commercial Officer. Also in the room are Diana Brainard, Senior Vice President and Head of our HIV and Emerging Viruses Therapeutic area; and John Sundy, Senior Vice President and Head of our Inflammation Therapeutic area.

今天電話會議的發言人有：董事長兼執行長丹尼爾·奧戴；執行副總裁兼財務長羅賓·華盛頓；以及首席商務官喬安娜·默西埃。房間裡還有資深副總裁兼 HIV 和新興病毒治療領域負責人 Diana Brainard；以及資深副總裁兼發炎治療領域負責人 John Sundy。

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.

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。

In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release as well as on the Gilead website.

此外，吉利德不承擔更新本次電話會議中任何前瞻性聲明的義務。我們將使用非公認會計準則財務指標來幫助您了解公司的基本業務表現。GAAP 與非 GAAP 的調整表已在盈利新聞稿以及吉利德網站上提供。

I'll now turn the call over to Dan.

現在我將把電話交給丹。

Thank you, Sung, and good afternoon, everyone. Thank you for joining today. I'll share a few opening comments and then turn the call over to Robin. And after that, Johanna will take you through the commercial highlights of the quarter as well.

謝謝宋，大家午安。感謝您今天的參與。我先說幾句開場白，然後把電話交給羅賓。之後，Johanna 還將帶您了解本季的商業亮點。

So let me start by saying I'm very pleased with the progress that we're making on all fronts here at Gilead and a strong third quarter results. Once again, we saw a significant growth in our HIV business, reaching an all-time high in quarterly HIV revenue. As you know, in my time at Gilead, I focused on 3 key areas since coming in: the pipeline, commercial delivery and people. And today in my brief remarks, I'll focus on the significant progress we've made in 2 of those areas, the pipeline and the people, and then Johanna will take you and talk to you about the excellent commercial performance later in the call.

首先，我想說我對吉利德在各個方面取得的進展以及強勁的第三季業績感到非常滿意。我們的 HIV 業務再次實現了顯著成長，季度 HIV 收入創歷史新高。如你所知，我在吉利德工作期間，主要專注於三個關鍵領域：產品線、商業交付和人員。今天，在我的簡短發言中，我將重點介紹我們在管道和人員這兩個領域取得的重大進展，然後 Johanna 將在電話會議的稍後部分與大家討論出色的商業表現。

So let me begin by saying a few words about our pipeline, starting with HIV. As you're aware, we received FDA approval for DESCOVY for PrEP earlier this month. This is a really important indication for us as it allows us to extend the benefits of DESCOVY to people who are at risk of HIV. To remind you, the approval was based on the DISCOVER trial, which demonstrates that DESCOVY is just as effective as Truvada and offers advantages in bone and renal safety parameters.

那麼，首先讓我簡單介紹一下我們的研發管線，從愛滋病毒感染者說起。如您所知，我們本月初獲得了 FDA 對 DESCOVY 用於 PrEP 的批准。這對我們來說是一個非常重要的指標，因為它使我們能夠將 DESCOVY 的益處擴展到有 HIV 感染風險的人。提醒一下，此次批准是基於 DISCOVER 試驗，該試驗表明 DESCOVY 與 Truvada 一樣有效，並且在骨骼和腎臟安全性參數方面具有優勢。

We are excited to build on DESCOVY's status as the most-prescribed dual NRTI backbone in the world by advancing its use in PrEP. Happy to say we've also received endorsement to begin the study of DESCOVY for PrEP in cisgender women, which will allow us to eventually bring the medicine to a broader group of people. Rest assured, we continue to remain focused on our HIV pipeline beyond our DESCOVY-based regimens as well on our long-acting antivirals programs, compounds that will treat -- highly treatment-experienced patients, and of course, on our CARE research as well.

我們很高興能夠鞏固 DESCOVY 作為全球處方量最大的雙 NRTI 骨幹藥物的地位，並推進其在 PrEP 中的應用。令人高興的是，我們也獲得了批准，可以開始研究 DESCOVY 在順性別女性中進行 PrEP 的療效，這將最終使我們能夠將這種藥物推廣到更廣泛的人群中。請放心，我們將繼續專注於我們基於 DESCOVY 療法之外的 HIV 產品線，以及我們的長效抗病毒藥物計畫、用於治療經驗豐富的患者的化合物，當然還有我們的 CARE 研究。

So turning to filgotinib. We've now filed for approval of filgotinib in rheumatoid arthritis in the EU and Japan and are on track to complete our filing in the United States by the end of the year. Our teams around the world are preparing for launch, and I'm encouraged about the potential of filgotinib to be best-in-class among the JAK inhibitors. In addition to rheumatoid arthritis, we're continuing to advance filgotinib together with our partner Galapagos. We have a comprehensive program across a number of other inflammatory diseases, including ulcerative colitis, which we expect to have data on next year. And in addition, we were successful in closing our partnership with Galapagos this past quarter.

所以轉而使用filgotinib。我們已向歐盟和日本提交了filgotinib用於治療類風濕性關節炎的上市申請，並預計在年底前完成在美國的上市申請。我們世界各地的團隊正在為上市做準備，我對filgotinib有望成為JAK抑制劑中的佼佼者感到鼓舞。除了類風濕性關節炎之外，我們也與合作夥伴 Galapagos 繼續推進 filgotinib 的研發。我們針對多種其他發炎性疾病制定了全面的研究計劃，包括潰瘍性結腸炎，我們預計明年將獲得相關數據。此外，上個季度我們成功與加拉巴哥群島達成了合作關係。

I'm looking forward to the American College of Rheumatology coming up in Atlanta so that we can share further updates on filgotinib. Researchers there will present further analysis in the FINCH 2 study, which evaluated filgotinib in patients with RA who previously -- who were previously treated with a biologic and then results of the pooled safety analysis of filgotinib across the FINCH program will also be presented and updated there.

我期待在亞特蘭大舉行的美國風濕病學會年會，以便我們能夠分享更多有關filgotinib的最新進展。研究人員將對 FINCH 2 研究進行進一步分析，該研究評估了 filgotinib 對先前接受過生物製劑治療的 RA 患者的療效，然後還將展示和更新 FINCH 項目中 filgotinib 的匯總安全性分析結果。

Turning to cell therapy. I would like to say a few words about Kite and our work in cell therapy. The teams down at Kite are busy preparing for the American Society of Hematology meeting, which will happen in early December, where in addition to exciting data from our ongoing clinical trials, we will share survival data for Yescarta at 3 years in large B-cell lymphoma as well as results from the registrational study of KTE-X19 in mantle cell lymphoma.

轉向細胞療法。我想簡單介紹一下Kite以及我們在細胞治療領域的工作。Kite 團隊正忙著準備 12 月初舉行的美國血液學會會議。屆時，除了公佈我們正在進行的臨床試驗的令人興奮的數據外，我們還將分享 Yescarta 在大 B 細胞淋巴瘤中 3 年的生存數據，以及 KTE-X19 在套細胞淋巴瘤中的註冊研究結果。

Recently, we also completed enrollment in the pivotal ZUMA-7 study of Yescarta in second-line large B-cell lymphoma, and we're excited about the potential this medicine could help for this group of patients. As we discussed also last quarter, we continue to see quarterly variations in Yescarta, but we're very confident in its future and the long-term trajectory of our cell therapy platform.

最近，我們也完成了 Yescarta 治療二線大 B 細胞淋巴瘤的關鍵性 ZUMA-7 研究的患者招募工作，我們對這種藥物可能對這類患者帶來的益處感到非常興奮。正如我們上個季度討論的那樣，Yescarta 的業績繼續出現季度波動，但我們對其未來以及我們細胞治療平台的長期發展軌跡充滿信心。

Finally, a few comments about our leadership team, which is now complete with 2 new appointments. Merdad Parsey will join us on November 1 as our Chief Medical Officer. Merdad, who previously led the early clinical development program at Genentech, will have responsibility for all of our global developments and medical affairs functions. Bill Lee will continue to lead our research organization and he will report directly to me working closely with Merdad. Merdad is an outstanding scientist and leader with a remarkable track record of success. And I believe that Merdad will be a tremendous asset to Gilead, maintaining a very high bar for innovation so that we can continue to build on our legacy of transformational medicines.

最後，我想對我們的領導團隊做幾點說明，目前團隊已新增兩名成員。Merdad Parsey將於11月1日加入我們，擔任首席醫療官。Merdad 先前曾領導 Genentech 的早期臨床開發項目，他將負責我們所有的全球開發和醫學事務職能。Bill Lee將繼續領導我們的研究機構，他將直接向我報告工作，並與Merdad密切合作。梅爾達德是一位傑出的科學家和領導者，擁有卓越的成功記錄。我相信，Merdad 將成為吉利德的一筆巨大財富，保持極高的創新標準，使我們能夠繼續鞏固我們在變革性藥物方面的輝煌成就。

I'm also very excited about the appointment of Andy Dickinson to the role of CFO. Andy has been at Gilead since 2016 and currently serves as our Executive Vice President of Corporate Development and Strategy. He transformed the way that the company approaches corporate development before I came in and expanding the kinds of transactions executed and implemented, a broader, more strategic approach to dealmaking here at Gilead. As of November 1, Andy will succeed Robin Washington, whose retirement we announced earlier this year. Happy that Robin will remain at Gilead in an advisory capacity through early next year, while we complete the reporting of our 2019 results.

我也非常高興安迪·迪金森被任命為財務長。Andy 自 2016 年起加入吉利德公司，目前擔任公司企業發展與策略執行副總裁。在我加入之前，他改變了公司進行企業發展的方式，擴大了執行和實施的交易類型，在吉利德採取了更廣泛、更具策略性的交易方式。截至 11 月 1 日，安迪將接替羅賓華盛頓的職位，我們已在今年稍早宣布了羅賓華盛頓的退休消息。很高興 Robin 將繼續留在 Gilead 擔任顧問，直到明年年初，同時我們將完成 2019 年業績報告。

I'd also like to take this opportunity to thank Robin for her outstanding contributions, dedication and tremendous commitment to Gilead. We wish her all the best in retirement. And I'm sure she'll continue to stay busy. I look forward to working with this outstanding group of leaders here at Gilead who bring a strong blend of skills and diverse perspectives to the path forward for our future.

我還要藉此機會感謝 Robin 對吉利德公司做出的傑出貢獻、奉獻精神和巨大投入。我們祝福她退休生活一切順利。我相信她會繼續忙碌下去。我期待與吉利德這群傑出的領導團隊共事，他們擁有強大的技能組合和多元化的視角，將為我們未來的發展道路帶來助力。

And in closing, I'm increasingly optimistic about the future and believe we are well positioned as we enter the last part of the year and look ahead to 2020 and beyond. We will continue to build on our success as we replenish the pipeline and bring the next wave of transformational advances to patients.

最後，我對未來越來越樂觀，相信我們已經做好充分準備，迎接今年的最後階段，並展望2020年及以後的發展。我們將繼續鞏固已取得的成功，不斷充實研發管線，並將下一波變革性進展帶給病患。

On behalf of the leadership team, I want to thank all of our employees and partners around the world for the dedication and hard work that led to the successful quarter and the results that you see here today and whose commitment will continue to make it successful in the future.

我謹代表領導團隊，感謝世界各地所有員工和合作夥伴的奉獻和辛勤工作，正是他們的付出才成就了本季度的成功以及今天大家所看到的成果，也正是他們的堅持，才使我們在未來繼續取得成功。

With that, I will now turn the call over to Robin.

接下來，我將把電話交給羅賓。

Thank you, Dan, for your kind words. It has been a privilege to serve as Gilead's CFO for the past 11 years and to work alongside such extraordinary colleagues to bring medicines to people around the world. I know the focus on this mission will continue, and I look forward to cheering Gilead on in 2020 and beyond.

丹，謝謝你的鼓勵。在過去 11 年裡，能夠擔任吉利德的首席財務官，並與如此傑出的同事們一起工作，為世界各地的人們帶來藥物，我深感榮幸。我知道這項使命的重心會繼續下去，我期待在 2020 年及以後繼續為基列國加油。

I'm pleased to report the financial results for the third quarter, which were marked by strong execution across our therapeutic areas, led by the continued growth of our HIV franchise and continued predictability of HCV.

我很高興地向大家報告第三季度的財務業績，該季度我們在各個治療領域都取得了強勁的業績，這主要得益於 HIV 產品線的持續增長和 HCV 產品線的持續穩定發展。

Total revenues for the third quarter were $5.6 billion with non-GAAP diluted earnings per share of $1.75. This compares to revenues of $5.6 billion and non-GAAP diluted earnings per share of $1.84 for the same period last year. As noted in the earnings press release, on a GAAP basis, we recorded a loss of $0.92 per share, primarily due to $3.92 billion or $2.40 per diluted share of upfront collaboration and licensing expense associated with our global research and development collaboration agreement with Galapagos.

第三季總營收為 56 億美元，非 GAAP 稀釋後每股收益為 1.75 美元。相比之下，去年同期營收為 56 億美元，非 GAAP 稀釋後每股收益為 1.84 美元。正如盈利新聞稿中所述，按 GAAP 準則，我們錄得每股虧損 0.92 美元，主要原因是與我們和 Galapagos 達成的全球研發合作協議相關的 39.2 億美元（即每股攤薄虧損 2.40 美元）的前期合作和許可費用。

Turning to product sales. Product sales for the third quarter were $5.5 billion, down 2% sequentially and up 1% year-over-year. In the U.S., product sales for the third quarter were $4.2 billion, up 4% sequentially and up 2% year-over-year. In Europe, product sales for the third quarter were $804 million, down 23% sequentially and down 8% year-over-year.

轉向產品銷售。第三季產品銷售額為 55 億美元，季減 2%，年增 1%。在美國，第三季產品銷售額為 42 億美元，季增 4%，年增 2%。在歐洲，第三季產品銷售額為 8.04 億美元，季減 23%，年減 8%。

The sequential performance was primarily impacted by 2 items. First, recall that the second quarter benefited from a $160 million adjustment for a statutory revenue clawback reserve. And second, the third quarter was negatively impacted by a statutory clawback reserve adjustment. These 2 factors, which primarily impacted our HCV and HIV revenues, caused an approximately $200 million decline between quarters.

順序表現主要受以下兩個因素影響。首先，需要指出的是，第二季受益於 1.6 億美元的法定收入追回準備金調整。其次，第三季受到法定追回準備金調整的負面影響。這兩個因素主要影響了我們的 HCV 和 HIV 收入，導致季度之間收入下降了約 2 億美元。

Turning to cell therapy. Worldwide, Yescarta sales for the third quarter were $118 million, up 57% year-over-year and down 2% sequentially. U.S. sales were $86 million for the third quarter, up 15% year-over-year and down 13% sequentially. In Europe, Yescarta sales were $32 million, up 52% sequentially as we continue to ramp in the region.

轉向細胞療法。Yescarta 第三季全球銷售額為 1.18 億美元，年增 57%，季減 2%。第三季美國銷售額為 8,600 萬美元，年增 15%，季減 13%。在歐洲，Yescarta 的銷售額為 3,200 萬美元，環比成長 52%，我們繼續在該地區擴大業務。

It is clear that cell therapy is a validated platform with hundreds of patients being treated on a quarterly basis in the U.S. Yescarta has established itself as a differentiated leader in an increasingly competitive environment. We will continue to focus our efforts on CAR T education in the community oncology setting to stimulate referrals of appropriate patients to cell therapy treatment centers.

很明顯，細胞療法是一個經過驗證的平台，在美國每季都有數百名患者接受治療。 Yescarta 已在競爭日益激烈的環境中確立了其差異化領導地位。我們將繼續致力於在社區腫瘤學領域進行 CAR-T 教育，以促進將合適的患者轉介至細胞治療中心。

We also observed CAR T eligible patients being enrolled in clinical trials at a much higher rate relative to commercial patients. As such and as Dan outlined, we anticipate further quarterly sales variations, but remain very confident in the future trajectory of Yescarta.

我們也觀察到，與商業患者相比，符合 CAR T 療法條件的患者參與臨床試驗的比例要高得多。正如丹所概述的那樣，我們預計季度銷售額還會有波動，但我們對 Yescarta 的未來發展軌跡仍然充滿信心。

Now turning to expenses. Non-GAAP R&D expenses were $954 million for the third quarter, up 13% compared to the same period last year, primarily due to increased investment in our oncology programs, HIV programs and research projects. Non-GAAP SG&A expenses were $967 million for the third quarter, up 14% compared to the same period last year, primarily due to higher promotional expenses in the U.S. and expenses associated with the expansion of Gilead's business in Japan and China.

現在來說說費用。第三季非GAAP研發費用為9.54億美元，比去年同期成長13%，主要原因是增加了對腫瘤計畫、愛滋病計畫和研究計畫的投資。第三季非GAAP銷售、一般及行政費用為9.67億美元，比去年同期成長14%，主要原因是美國促銷費用增加以及吉利德在日本和中國業務擴張相關的費用。

Moving to the balance sheet. During the third quarter, we generated $2.6 billion in cash from operations and ended the quarter with $25.1 billion in cash and investments. We paid $5.5 billion in connection with our global research collaboration and equity investment in Galapagos, which was classified in our cash flow statement as cash from investing activities and includes a $1.1 billion equity investment. We also paid $1.5 billion of debt used to finance our acquisition of Kite. We paid cash dividends of $804 million and repurchased 3.4 million shares of stock for $223 million.

接下來查看資產負債表。第三季度，我們從經營活動中獲得了 26 億美元的現金，季末現金和投資總額為 251 億美元。我們為與 Galapagos 的全球研究合作和股權投資支付了 55 億美元，這筆款項在我們的現金流量表中被歸類為投資活動產生的現金，其中包括 11 億美元的股權投資。我們還償還了用於收購 Kite 的 15 億美元債務。我們支付了 8.04 億美元的現金股息，並以 2.23 億美元的價格回購了 340 萬股股票。

Turning to our guidance. As we move closer to the end of 2019, we are narrowing our guidance ranges as follows: Net product sales are expected to be in the range of $21.8 billion to $22.1 billion. Non-GAAP R&D expenses are expected to be in the range of $3.7 billion to $3.8 billion. We expect non-GAAP SG&A expenses to be in the range of $4 billion to $4.1 billion. All other components of our guidance remain unchanged.

請參考我們的指導意見。隨著 2019 年接近尾聲，我們將業績指引範圍縮小如下：預計淨產品銷售額將在 218 億美元至 221 億美元之間。非GAAP研發費用預計在37億美元至38億美元之間。我們預計非GAAP SG&A費用將在40億美元至41億美元之間。我們指南的其他所有組成部分均保持不變。

Our guidance is subject to a number of uncertainties, which are outlined in Slides 22 and 23 in our earnings call presentation.

我們的業績指引受到許多不確定因素的影響，這些因素已在我們的財報電話會議簡報的第 22 和 23 頁中進行了概述。

I'll now turn the call over to Johanna.

現在我將把電話交給喬安娜。

Thanks, Robin, and good afternoon, everyone. So as I've had the chance to settle into my role, I've been really impressed with the talent here at Gilead and the potential we have to reach even more patients with our medicines. I want to talk today about a few areas: the continued strength of our HIV business, including our recent launch of DESCOVY for PrEP; durability of HCV; and finally, touch briefly on our cardiopulmonary business; and close by discussing our filgotinib launch preparations.

謝謝羅賓，大家下午好。隨著我逐漸適應新的工作崗位，我對吉利德的人才以及我們利用藥物惠及更多患者的潛力印象深刻。今天我想談談幾個方面：我們 HIV 業務的持續強勁發展，包括我們最近推出的 PrEP 產品 DESCOVY；HCV 的持久性；最後，簡要談談我們的心肺業務；最後討論一下我們 filgotinib 的上市準備工作。

So let's start with HIV. Global HIV sales for Q3 were $4.2 billion, up 4% sequentially and 13% year-over-year. This marks the sixth consecutive quarter of double-digit year-over-year growth. As Dan noted, this is an all-time high for quarterly HIV product sales. U.S. HIV product sales were $3.4 billion in Q3, up 6% sequentially and 14% year-over-year. The year-over-year increase was driven by underlying prescription demand growth of 13%, mainly Biktarvy. Biktarvy was the #1 prescribed regimen in the U.S. in the quarter.

那我們就從愛滋病說起吧。第三季全球 HIV 銷售額為 42 億美元，季增 4%，年增 13%。這是連續第六個季度實現兩位數同比增長。正如丹所指出的，這是愛滋病產品季度銷售額的歷史最高紀錄。美國愛滋病產品第三季銷售額為 34 億美元，季增 6%，年增 14%。年成長主要得益於處方藥需求成長 13%，其中以 Biktarvy 為主。本季度，Biktarvy是美國處方量排名第一的治療方案。

In prevention, there are now approximately 224,000 people taking TRUVADA for PrEP, an increase of approximately 25% year-over-year of active patients. Our teams are now in the field with DESCOVY with its recent approval in PrEP. We initiated efforts to educate health care providers and people at risk for HIV about DESCOVY immediately following the approval and are really quite pleased with initial and anecdotal feedback from providers.

在預防方面，目前約有 224,000 人服用 TRUVADA 進行 PrEP，活躍患者人數比前一年增加了約 25%。我們的團隊目前正在使用 DESCOVY 進行實地推廣，該產品最近已獲準用於 PrEP。DESCOVY核准後，我們立即著手向醫療保健提供者和有感染愛滋病毒風險的人群普及相關知識，並對提供者的初步回饋和軼事回饋感到非常滿意。

Turning to Europe. Q3 HIV product sales were $558 million, down 10% sequentially and 4% year-over-year. The year-over-year decline was expected due to the broad availability of generic versions of Truvada. The impact of generics is starting to wane as the launches of our DESCOVY-based products, namely Biktarvy, progress. As Robin just mentioned, the sequential performance was impacted by an adjustment for statutory clawback reserve in Europe, which benefited the second quarter.

轉向歐洲。第三季 HIV 產品銷售額為 5.58 億美元，季減 10%，年減 4%。由於 Truvada 的仿製藥廣泛上市，同比下降在意料之中。隨著我們基於 DESCOVY 的產品（即 Biktarvy）的上市，仿製藥的影響開始減弱。正如 Robin 剛才提到的，由於歐洲法定追回準備金的調整，環比業績受到影響，這對第二季有利。

Biktarvy is now available across the EU5 and continues to grow. It's on track to be the best HIV launch in Europe and is #1 in naive and switch across Germany, France and Spain. It recently launched in Italy and the U.K. and is off to a strong start in both those countries.

Biktarvy 目前已覆蓋歐盟五國，並且仍在不斷發展壯大。它有望成為歐洲最好的 HIV 疫苗上市，並在德國、法國和西班牙的初治患者和轉診患者中排名第一。它最近在義大利和英國推出，並且在這兩個國家都取得了強勁的開局。

Moving on to HCV. Global Q3 HCV sales were $674 million, down 20% sequentially and 25% year-over-year. U.S. product sales for Q3 were $380 million, up 7% sequentially and down 22% year-over-year. The sequential performance was driven by the continued uptake of authorized generics, which has improved our overall competitive position in the U.S.

接下來是丙型肝炎病毒。第三季全球丙型肝炎病毒（HCV）銷售額為 6.74 億美元，較上季下降 20%，年減 25%。美國第三季產品銷售額為 3.8 億美元，季增 7%，年減 22%。業績的持續成長得益於授權仿製藥的不斷普及，這提高了我們在美國的整體競爭力。

In Europe, HCV product sales for the second quarter were $111 million, down 60% sequentially and 45% year-over-year. As anticipated, the sequential performance was negatively impacted by the adjustment for statutory clawback reserve in Europe, which benefited Q2. Overall, the HCV market continues to see a more predictable decline in patient starts and perform in line with our expectations.

在歐洲，第二季丙型肝炎產品銷售額為 1.11 億美元，較上季下降 60%，較去年同期下降 45%。正如預期的那樣，由於歐洲法定追回準備金的調整，環比業績受到了負面影響，但第二季業績有所改善。總體而言，HCV 市場持續呈現更可預測的患者數量下降趨勢，並符合我們的預期。

Before closing, I wanted to just make a few comments on our cardiopulmonary business, where we have seen generic competition enter the market. As anticipated, significant volume erosion has occurred and as of September, we have seen an 85% erosion of Ranexa and 60% erosion of Letairis, a trend that we expect to continue.

在結束之前，我想就我們的心肺業務談幾點看法，我們已經看到仿製藥競爭進入市場。正如預期的那樣，銷量出現了顯著下滑，截至 9 月，Ranexa 的銷量下滑了 85%，Letairis 的銷量下滑了 60%，我們預計這一趨勢還將繼續。

Finally, I have spent time recently both Europe and Japan where our teams have completed the regulatory filings for filgotinib in rheumatoid arthritis. Launch preparations are well underway in both regions as well as in the United States, where as Dan noted, we plan to file before the end of the year.

最後，我最近在歐洲和日本都待了一段時間，我們的團隊在那裡完成了filgotinib治療類風濕性關節炎的監管申報工作。這兩個地區以及美國的上市準備工作都在順利進行中，正如丹所指出的，我們計劃在年底前提交申請。

I believe that we truly have an opportunity to make a difference in the lives of people with RA and in the future, other inflammatory diseases. We're actively preparing for competitive and innovative launch of a differentiated JAK inhibitor across our key markets. I really look forward to working with this great team of people to deliver on the promise of these medicines. So thank you very much for joining today's call and now, let's turn it over to questions. Operator?

我相信我們確實有機會改變類風濕性關節炎患者的生活，未來也可能改變其他發炎性疾病患者的生活。我們正在積極準備，以便在我們的主要市場推出具有競爭力和創新性的差異化JAK抑制劑。我非常期待與這支優秀的團隊合作，實現這些藥物的承諾。非常感謝各位參加今天的電話會議，現在，讓我們進入提問環節。操作員？

(Operator Instructions) Our first question comes from the line of Michael Yee with Jefferies.

（操作說明）我們的第一個問題來自 Jefferies 的 Michael Yee。

I had a question for Dan. Obviously, Dan, you've spent a lot of time this year putting in the right people, getting everything all set up, you did a Galapagos deal to build up the pipeline a bit. I guess, in thinking about the pipeline and building that out, where are you focusing your priorities on? How should we think about your next area, whether that's in NASH or oncology? How should we think about that? And maybe just give us a little state of the union there?

我有個問題想問丹。顯然，丹，你今年花了很多時間引進合適的人才，把一切都安排妥當，你還和 Galapagos 達成了一項協議，以擴充我們的人才儲備。我想，在考慮管道建設和完善的過程中，你們的優先事項是什麼？我們應該如何考慮你的下一個研究領域，無論是 NASH 還是腫瘤學？我們該如何看待這個問題？或許可以給我們簡單報告國情？

Yes. Thanks, Michael, very much for the question. And delighted that we now have the team coming together for the future. I think it's a really good diverse team with some strong Gilead legacy colleagues as well as combined with some talent from the outside the organization with different perspectives. And I think it's going to lead to a really strong, good team that will help us drive kind of the future chapters of Gilead moving forward.

是的。謝謝你的提問，麥可。很高興我們現在擁有了面向未來的團隊。我認為這是一個非常優秀的多元化團隊，既有吉利德經驗豐富的老員工，也有來自組織外部、擁有不同視角的優秀人才。我認為這將打造一支非常強大、優秀的團隊，幫助我們推動吉利德公司未來的發展篇章。

Also pleased, Michael, that we had the Galapagos transaction finalized in the quarter, where we're obviously getting going now on our deeper collaboration beyond filgotinib. And as I've said to you in the past and I'll say it again, I mean, I think the team here and I have the pipeline as our #1 priority, of course. And that -- we approach that from a variety of different ways. One is the strength of our internal pipeline, looking for ways to accelerate differentiated medicines that we can internally and with Galapagos now significantly expanding our research base in addition to other collaborations we have externally that allow us to essentially double our research base of medicines coming into the portfolio -- the development portfolio.

Michael，我也很高興我們在本季完成了 Galapagos 的交易，顯然我們現在正在 filgotinib 之外進行更深入的合作。正如我過去跟你們說過的那樣，我還要再說一遍，我的意思是，我認為我和團隊的首要任務當然是培養人才。而我們——從各種不同的方式來探討這個問題。一是我們內部研發管線的實力，我們正在尋找加速研發差異化藥物的方法，而 Galapagos 現在大大擴展了我們的研發基礎，此外，我們與其他外部機構的合作也使我們能夠將研發藥物的數量增加一倍，從而壯大我們的研發組合。

In terms of therapeutic area, I would say our approach to external partnerships and M&A will be very much the same of what you saw in the past. So first and foremost, it will be driven by science, driven by where we think the most unique opportunities are. Secondarily it will be informed by our own expertise. As you know, we play across 4 therapeutic areas today and strong scientific understanding in the base in antivirals and immunomodulation. And there is no one size fits all, of course. I mean, at times, it makes sense to just do a partnership, but other times, it makes sense to do a full acquisition and other times, it makes sense to do something like a Galapagos arrangement where we have a deep partnership associated with that. So we'll continue on in that area.

就治療領域而言，我認為我們對待外部合作和併購的態度將與過去你們所看到的非常相似。所以，首先，它將由科學驅動，由我們認為最獨特的機會所在驅動。其次，我們也會借鏡自身的專業知識。如您所知，我們目前涉足 4 個治療領域，並在抗病毒和免疫調節方面擁有強大的科學基礎。當然，沒有一種方案可以適用於所有人。我的意思是，有時候，建立合作關係是合理的；但有時候，全面收購是合理的；而有時候，像 Galapagos 這樣的合作安排是合理的，因為我們與該安排建立了深厚的合作夥伴關係。所以我們會繼續在這個領域開展工作。

I think more to come as the team comes together as we continue to evaluate. Certainly, the areas that you mentioned are areas that we're looking at carefully to complement our internal expertise, but we're not driven by any one therapeutic area. We're driven much more by where is the next innovation going to come from in science and how do we complement that portfolio with an acknowledgment, by the way, that we understand that we have to accelerate the development of our later-stage pipeline as well. And that can happen by both accelerating our internal pipeline or having partnerships arrangements with companies outside of the Gilead orbit today. So Michael, more to come. And obviously, some of the conferences coming up and into next year, I can be even more specific and articulate about how some of our strategies are forming.

我認為隨著團隊的磨合和我們持續的評估，會有更多成果公佈。當然，您提到的這些領域正是我們正在認真研究的，以補充我們內部的專業知識，但我們並非專注於任何單一的治療領域。我們更關注的是科學領域的下一個創新將來自哪裡，以及我們如何完善現有產品組合。順便一提，我們也意識到，我們必須加快後期研發管線的開發。這可以透過加快我們內部研發管線或與吉利德集團以外的公司建立合作關係來實現。邁克爾，敬請期待更多內容。顯然，在即將召開的一些會議以及明年的一些會議上，我可以更具體、更清晰地闡述我們的一些策略是如何形成的。

Our next question comes from Brian Abrahams with 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。

So you narrowed the R&D and SG&A guidance to the upper end of the previous ranges. And so, I guess -- I'm wondering maybe bigger picture, perhaps longer term, especially as we're getting closer now to the filgotinib launch, how do you guys balance the importance of margin preservation and earnings growth against the potential to invest as you build out in inflammation? And how might the changes in leadership potentially influence this?

因此，你們將研發和銷售、管理及行政費用指導範圍縮小到之前範圍的上限。所以，我想——從更宏觀的角度來看，或許從長遠來看，尤其是在我們越來越接近filgotinib上市之際，你們是如何平衡利潤率保持和盈利增長的重要性與在炎症領域進行投資的潛力之間的呢？領導階層的更迭可能會對此產生怎樣的影響？

Yes. Let's let Robin give her commentary, Brian, and then maybe I'll add as well, so please.

是的。布萊恩，咱們先讓羅賓發表一下評論吧，之後我或許會補充一些內容，拜託了。

Brian, thanks for the question. I'd say we manage them very carefully. As you know, we've always been a very highly efficient organization, really focused on operational excellence and ensuring that even as we've grown, we've grown profitably as we think about margins. And at the same time, as you've heard me say before, we're always balancing the need to invest for the long term. And, as you know, that can have implications in the short term. You've seen us with previous launches and with acquisitions make the necessary investments upfront that may yield shorter operating margins in a short term, but ultimately get us to higher revenues in overall margins long term. So I think that's how we think about our model. There's -- it's not by quarter or by year, it's really ensuring that when we make investments that we make the necessary actions in the short time to ensure the overall ROI on those investments. And I'll turn it over to Dan to talk about the future, but I think we're pretty much aligned going forward.

布萊恩，謝謝你的提問。我認為我們對它們管理得非常謹慎。如您所知，我們一直是一個非常高效的組織，真正專注於卓越運營，並確保即使在我們發展壯大的過程中，我們也能實現盈利增長，因為我們注重利潤率。同時，正如你之前聽我說過的那樣，我們始終在權衡長期投資的需求。而且，正如你所知，這可能會在短期內產生影響。你們已經看到，我們在先前的發布和收購中都會進行必要的預先投資，這在短期內可能會導致營運利潤率降低，但最終會讓我們長期獲得更高的整體利潤率。所以我覺得這就是我們對這個模型的理解。這不是按季度或按年計算的，而是真正確保我們在進行投資時，能夠在短期內採取必要的行動，以確保這些投資的整體投資回報率。接下來我會把麥克風交給丹，讓他談談未來，但我認為我們未來的方向基本上一致。

It's well said, Robin. And Brian, you may want to hear it from my vantage point as well, just particularly with the CFO transition to make sure you understand the stability from my side as well. So I have really admired Gilead's efficiency as Robin mentioned and the careful management of expenses. And I think that's something that we will continue to make sure that we emphasize here as well. I've also been a student of the history here at Gilead, and I've looked back in the past and seen in times of important launches, that investment has increased correspondingly in the interest of patients, in the interest of shareholders. And I think that's -- that type of philosophy, I think, will continue. And certainly, we will also be -- as we have generic erosion, of course, coming now this year and next year, we also have the ability to redeploy those resources as we already have done with cardiopulmonary to other areas of focus and interest, including the upcoming -- or the current launch for DESCOVY in PrEP. And then we will also make sure that we have a competitive launch of filgotinib because we know that it will be essential to have the right share of voice to get that off to a good start. We have one chance to launch a product in this industry, and therefore, we have to make that accordingly. So as we get into providing you with more guidance in 2020, we can elaborate a little bit further about how we see that expense management for next year. But I hope you get a sense that much of the discipline that Gilead has had in the past, you can expect to have in the future as well, Brian.

說得好，羅賓。布萊恩，你可能也想從我的角度聽聽我的看法，尤其是在財務長過渡期間，以確保你也能從我的角度了解公司的穩定性。正如羅賓所提到的，我非常欣賞吉利德的效率和對費用的謹慎管理。我認為這也是我們在這裡會繼續強調的一點。我也研究過吉利德的歷史，回顧過去，我發現，在重要的產品發布時期，為了病人的利益和股東的利益，投資也相應增加。我認為這種理念將會持續下去。當然，隨著今年和明年通用侵蝕的到來，我們也有能力將這些資源重新部署到其他重點和感興趣的領域，就像我們已經對心肺疾病所做的那樣，包括即將推出的 DESCOVY 在 PrEP 領域的應用。然後，我們也要確保 filgotinib 的上市具有競爭力，因為我們知道，要取得良好的開端，獲得正確的市佔率至關重要。在這個行業，我們只有一次推出產品的機會，因此，我們必須認真對待這次機會。因此，在 2020 年我們將為您提供更多指導之際，我們可以進一步詳細說明我們對明年費用管理的看法。但我希望你能感受到，基列過去所擁有的許多紀律，你以後也可以期待繼續擁有，布萊恩。

Our next question comes from Geoff Meacham with Bank of America Merrill Lynch.

下一個問題來自美國銀行美林證券的傑夫‧米查姆。

Congrats, Andy and Robin. It's been great to work together. Wish you the best. Just wanted to ask about HIV market expansion outside of PrEP. And with Biktarvy, the share gains are impressive and with its profile, are you seeing an uptick though in treated patients on ART overall? I just wanted to ask because HIV market expansion used to be a secondary driver of the market, but I'm not sure about that today. And how do you think this differs in Europe?

恭喜安迪和羅賓。合作非常愉快。祝你一切順利。想問一下PrEP以外的HIV市場擴張情形。而 Biktarvy 的市佔率成長令人印象深刻，憑藉其良好的口碑，您是否看到接受 ART 治療的患者總數有所增加？我只是想問，因為愛滋病市場擴張過去是市場的次要驅動因素，但我現在不太確定了。你認為這在歐洲有何不同？

Maybe I'll take that one, Geoff. It's Johanna. I think as you're mentioning, the HIV business overall and treatment is a huge part of that, it's about 80% of our total HIV business, has never been stronger. And what we're seeing, it's a bit of a mix what you're saying, but in both U.S. and Europe, you have about 80% of the patients that are switch patients and 20% are naïve patients. So the naïve patients is a smaller play and less of a market expansion per se to your earlier point, but much more in the switch. And so where the switch come from are really important to us for Biktarvy. And what we're seeing with Biktarvy and that's been our strategy all along in our expectation is we are seeing about 20% to 25% are coming from dolutegravir-based regimens and about a 1/3 coming from Truvada-based regimen and then the rest, another 1/3 probably, from Genvoya. And so that's the piece where from a switch standpoint that's the biggest, most important piece of the business. Both in U.S. and Europe, it's quite similar, actually. The challenge in Europe is, obviously, more -- there is more Truvada piece of the puzzle just because of the genericization in Europe. But overall, what we're seeing is very consistent, both in naïve and switch, and Biktarvy is #1, not just in the U.S., but also in Germany, France and Spain. And we only just got reimbursement in the last quarter for U.K. and Italy. So -- but those launches are off to the similar, very consistent way of launching that we've seen in the other markets.

或許我會接受那個，傑夫。是喬安娜。我認為正如您所提到的，愛滋病業務整體而言，治療業務是其中非常重要的一部分，約占我們愛滋病業務總量的 80%，而且從未如此強勁。我們看到的情況正如你所說，有點複雜，但在美國和歐洲，大約 80% 的患者是轉診患者，20% 是初次就診的患者。所以，對於缺乏經驗的患者來說，這與其說是市場擴張，不如說是市場轉型，而不是市場擴張，這與你先前的觀點有所不同。因此，對於 Biktarvy 來說，這種轉變的來源對我們來說非常重要。我們看到 Biktarvy 的情況，也正是我們一直以來的策略和預期，大約 20% 到 25% 的病例來自基於多替拉韋的治療方案，大約 1/3 的病例來自基於 Truvada 的治療方案，其餘的，可能還有 1/3 的病例來自 Genvoya。因此，從交換器的角度來看，這是業務中最大、最重要的部分。實際上，美國和歐洲的情況非常相似。顯然，歐洲面臨的挑戰更大——由於歐洲的通用化，Truvada 的市場份額更大。但總的來說，我們看到的情況非常一致，無論是在新手還是新手用戶中，Biktarvy 都是排名第一，不僅在美國，而且在德國、法國和西班牙也是如此。直到上個季度，我們才收到英國和義大利的報銷款項。所以——但這些產品的上市方式與我們在其他市場看到的非常相似、非常一致。

Thank you, Geoff. So we'll go on to the next questioner.

謝謝你，傑夫。那我們就繼續回答下一位提問者的問題。

Our next question comes from the line of Geoff Porges with SVB Leerink.

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

I'm just wondering if you could help me understand a little bit on the research side. You've sort of glossed over that a bit. First, Dan, could you break out the $4 billion or so in annual spend that you have now between immunology, oncology, hepatology and then research? Just give us a sense of those allocations. And then related to that, Dan, could you talk about if you were to contemplate significant M&A or for that matter additional licensing, do you envisage that, that $4 billion run rate will have to go up to accommodate these -- those new programs? Or do you have some savings from big trials coming to an end and/or other efficiencies that might take the $4 billion down and accommodate incremental programs from outside the company?

我只是想請教您一些研究方面的知識。你似乎有點輕描淡寫了。首先，丹，你能否詳細說明一下你目前每年在免疫學、腫瘤學、肝病學和研究方面的大約 40 億美元支出是如何分配的？請簡單介紹一下這些分配情況。丹，關於這一點，如果你考慮進行重大併購或額外的許可，你認為40億美元的營運成本是否必須提高才能容納這些新項目？或者，大型試驗的結束和/或其他效率提升措施是否能為您節省一些資金，從而減少 40 億美元的支出，並允許公司外部開展增量專案？

Terrific. Yes. Thanks, Geoff. And actually, I'm glad you asked the question because on the previous question, I spoke more about how we look at allocation resources on the commercial side more so than the research side. So, yes, let me first of all state that -- the first part of your question relative to how we allocate that across therapeutic areas is not something that we disclose accordingly. So I can't help you with that, but I think I can help you with the forward question, which is, as we think forward to either partnerships or M&A, how is that going to help -- or what impact will that have, if you like, on the overall R&D spend. Now I think there is one aspect of that that's very important, which is -- and you mentioned it a bit. But, a, we're constantly prioritizing our portfolio internally. And that is based upon making sure that we have the most attractive programs that we're funding, every organization has to draw a line, and I think we also have to do that as well. And of course, things change because of the nature of data that's read out, competitive environments, a variety of things that happen. So the portfolio is constantly kind of evolving and moving internally based on that portfolio. And therefore, to your point, there are times when we stop studies, studies come to a natural conclusion and they've been successful, and we have those to then reinvest, again, accordingly.

了不起。是的。謝謝你，傑夫。實際上，我很高興你問了這個問題，因為在上一個問題中，我更多地談到了我們如何看待商業方面的資源分配，而不是研究方面的資源分配。所以，是的，首先我要說明——關於我們如何將這些資金分配到各個治療領域的問題，我們不會公開披露。所以這個問題我幫不了你，但我認為我可以幫你解答接下來的問題，那就是，當我們展望未來，考慮合作或併購時，這將如何幫助——或者說，這將對整體研發支出產生什麼影響。我認為其中有一個面向非常重要，那就是──你剛才也稍微提過。但是，我們一直在內部對我們的投資組合進行優先排序。這是基於確保我們資助的計畫最具吸引力這一目標，每個組織都必須劃定界限，我認為我們也必須這樣做。當然，由於讀取的資料的性質、競爭環境以及各種其他因素，情況也會改變。因此，投資組合會根據該投資組合在內部不斷發展和變化。因此，正如你所說，有時我們會停止研究，研究自然而然地結束，並且取得了成功，然後我們可以相應地重新投資。

Many of the structures that we've looked at in our partnerships have also been designed to be, first of all, innovation forward, but also allow for some balanced risk across the portfolio and spend. For instance, with Galapagos, our relationship with them is that they are covering trials up until Phase II and they take the decisions and they take the risk associated with that and all the diversity and benefit that comes from having another organization look at that differently. And then post our opt-in, of course, then we would start to incur expenses on our R&D line as well. So many of our partnerships and collaborations have been designed with that in mind as well, and we'll continue to do it that way to be efficient with risk versus investment. And I think that's the way we'll continue to look at moving forward. So more to come on that. I would just say -- I mean, the one thing we do disclose, Geoff, on the R&D line is that around 15% to 20% of the $4 billion goes into research and the remaining is into development human trials accordingly. So that I can give you. But we don't really break it down further by therapeutic area. Does that help?

我們在合作關係中考察的許多結構，其設計初衷首先是創新，其次是允許在整個投資組合和支出中保持一定的風險平衡。例如，我們與 Galapagos 的關係是，他們負責 II 期臨床試驗，他們做出決定，承擔相關的風險，以及由其他組織以不同視角看待問題所帶來的多樣性和益處。當然，在我們發布用戶選擇加入資訊後，我們的研發投入也會增加。我們許多合作夥伴關係和合作都是在設計之初就考慮到這一點，我們將繼續以這種方式提高風險與投資的效率。我認為這就是我們未來將繼續採取的方式。關於這一點，後續還會有更多討論。我只想說——傑夫，關於研發方面，我們確實要透露的一點是，40億美元中大約有15%到20%用於研究，其餘部分則用於相應的開發人體試驗。這樣我才能給你。但我們並沒有按治療領域進一步細分。這樣有幫助嗎？

Somewhat.

有些。

As much as I can, I think. But thanks, Geoff.

我想，我會盡我所能的。不過還是要謝謝你，傑夫。

Our next question comes from Matthew Harrison with Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

I guess, I was hoping you could just talk briefly, I know it's very early in the switch from Truvada to DESCOVY. But maybe you could talk about your expectations for some of the markers we should be looking for there and then maybe anecdotal feedback as you've maybe been in the market a couple weeks already with that.

我想，我希望你能簡單地談談，我知道現在從 Truvada 過渡到 DESCOVY 還處於非常早期的階段。不過，或許您可以談談您對我們應該關注的一些指標的預期，然後，鑑於您可能已經在這個市場待了幾個星期，或許還可以提供一些軼事反饋。

Thanks, Matthew, for the question. So, yes, only a few weeks in, right? We got the approval early October. But even within a few weeks, we're off to a strong start. I think the team is very excited about it, but more importantly, the early feedback from physicians is very positive, and we're hearing a lot of enthusiasm from our prescribers. I do want to explain that the PrEP market is a little bit different than the treatment market and that is that it's much larger in the number of prescribers. So there's over 50,000 prescribers that have actually written at least 1 script of PrEP with Truvada. So having said that, more than half of the volume that we're seeing in PrEP is actually very concentrated in a couple of thousand specialists who also prescribe in treatment. So that has been our #1 focus and target, physicians that we have been calling on over the last couple of weeks because these are folks that obviously enlarge this volume pool, but also folks that have experienced converting from TDF to TAF and also understand the value of DESCOVY and its clinical profile, specifically around the safety with bone and renal. So we assume a very similar conversion than what we've seen in the past. We have a lot of experience here of TDF to TAF conversions, and we assume that same conversion rate will happen with these top prescribers.

謝謝馬修的提問。是的，才過了幾個星期，對吧？我們在十月初就獲得了批准。但即使只有短短幾週時間，我們也取得了強勁的開局。我認為團隊對此感到非常興奮，但更重要的是，來自醫生的早期回饋非常積極，我們從處方醫生那裡也聽到了很多熱情。我想解釋一下，PrEP 市場與治療市場略有不同，那就是 PrEP 的處方醫生數量要多得多。因此，已有超過 50,000 名處方醫生開出至少一張 Truvada PrEP 處方。所以說，我們看到的PrEP藥物使用量的一半以上實際上非常集中在數千名專科醫生身上，他們也開立治療處方。因此，這已成為我們最重要的關注點和目標，即在過去幾周里我們一直聯繫的醫生，因為這些人顯然可以擴大我們的業務量，而且他們也經歷過從 TDF 轉換為 TAF 的情況，並且了解 DESCOVY 的價值及其臨床概況，特別是其在骨骼和腎臟方面的安全性。因此，我們預期轉化率將與過去觀察到的情況非常相似。我們在這方面有很多 TDF 到 TAF 轉換的經驗，我們認為這些頂級處方醫生也會有相同的轉換率。

For the balance of the volume, obviously, we are assuming a little bit of a slower uptake with those prescribers, just because it's so much more diffuse. But having said that, we've augmented the field team. I think Dan mentioned this earlier, how we've taken a lot of our field forces from the cardiopulmonary in light of the generics hitting there. We basically trained them and moved them over there to supplement the team and also augmented our consumer approach to get really rapid awareness of DESCOVY, both to physicians as well as targeted consumers. So, so far so good, very excited about the launch and probably in the next quarter, we'll have more to talk about with data.

至於剩餘的用量，顯然，我們假設這些處方醫生的接受速度會慢一些，因為這種藥物的分佈更加分散。但即便如此，我們也已經擴充了現場團隊。我想丹之前也提到過這一點，鑑於仿製藥衝擊心肺領域，我們已經從該領域抽調了許多現場人員。我們基本上對他們進行了培訓，並將他們調到那裡以補充團隊，同時加強了我們的消費者策略，以便讓醫生和目標消費者都能迅速了解 DESCOVY。目前一切順利，對產品發布感到非常興奮，可能在下一個季度，我們會有更多數據可以討論。

Our next question comes from the line of Alethia Young with Cantor Fitzgerald.

我們的下一個問題來自 Alethia Young 與 Cantor Fitzgerald 的對話。

I just wanted to talk a little bit about NASH strategy from here. I understand you have the ATLAS study in the fourth quarter, but I also saw you started a semaglutide GLP-1 study combination with doubles and triples. So can you maybe frame for us how you think about like what might be your backbone asset in NASH and possibly your plans going forward there?

我只想簡單談談接下來的 NASH 策略。我知道你們在第四季度有 ATLAS 研究，但我也看到你們開始了一項司美格魯肽 GLP-1 研究，包括雙劑量和三劑量組合。那麼，您能否為我們闡述一下，您認為您在 NASH 領域的核心資產是什麼，以及您未來的發展計畫？

Yes. Thank you very much, Alethia. So I think you rightly pointed, kind of an important data point coming up here that will allow us to think about how we pivot our NASH strategy moving forward, and that's the ATLAS study that we will be reading out before the end of the year. For those of you that don't know, I mean, that's a combination trial that will allow us to look at the results of a variety of different combinations on the progression of NASH. But as you also know, I mean, we've had a number of other collaborations we've looked at with Novo Nordisk on GLP-1 and some of the other ones that you've already mentioned there, Alethia, that are approaching this from different angles as well. So I do think though that most progressed clinical trial is currently the ATLAS trial. And once we can see the results for that and dig into that, then I think it will help us really understand how to progress ahead with NASH in what format and what way.

是的。非常感謝你，阿萊西亞。所以，我認為你指出的很正確，這裡即將出現一個重要的數據點，這將使我們能夠思考如何調整我們未來的 NASH 戰略，那就是我們將在年底前公佈的 ATLAS 研究。對於那些不了解的人來說，我的意思是，這是一項聯合試驗，它將使我們能夠觀察各種不同組合對 NASH 進展的影響結果。但你也知道，我們和諾和諾德公司在 GLP-1 方面還有許多其他的合作，還有你剛才提到的其他一些公司，比如 Alethia，它們也從不同的角度著手研究這個問題。所以我認為，目前進展最快的臨床試驗是 ATLAS 試驗。一旦我們能夠看到結果並深入研究，我認為這將有助於我們真正了解如何以何種形式和方式推進 NASH 的研究。

I would just mention that as we've always mentioned, we think that NASH is a very high unmet medical need, but also a challenging disease to develop in, given the nature of the disease, given the heterogeneity of the disease, given the endpoints. And yet, we think a company like Gilead with expertise in this area need to be informed by the science and follow the science to see what our path forward will be. So more on the NASH strategy after the ATLAS trial at the end of this year.

我想補充一點，正如我們一直以來所提到的，我們認為 NASH 是一種尚未得到充分滿足的醫療需求，但考慮到該疾病的性質、異質性以及終點指標，它也是一種難以開發的疾病。然而，我們認為像吉利德這樣在該領域擁有專業知識的公司需要以科學為指導，並遵循科學的發展方向，才能找到前進的道路。所以，關於 NASH 的策略，我們將在今年年底的 ATLAS 試驗之後再做更多討論。

Our next question comes from the line of Umer Raffat with Evercore ISI.

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

I wanted to focus on a couple of R&D topics, if I may. One, on filgotinib. I noticed FDA called in the tofacitinib review documents, FDA effectively implied class labeling on thrombosis risk for the class. And my question is what's your expectation? Do you think you'll get a black box for thrombosis? And do you think that impacts commercial uptake?

如果可以的話，我想重點談談幾個研發方面的議題。一、服用filgotinib。我注意到 FDA 調取了託法替尼的審查文件，FDA 實際上暗示了該類藥物有血栓風險的類別標籤。我的問題是，你的期望是什麼？你覺得你會因為血栓而收到黑盒子嗎？你認為這會影響商業應用嗎？

And then secondly, there was a program in your pipeline, which I was starting to get really excited about, perhaps mostly because it was sort of in the -- exactly in the type of thing Gilead has been very good at, novel Nucs, GS-9131 and it could have formed a base of life cycle management. I noticed it's not in the slide deck this time around, and I was wondering if you could catch us up on any learnings from that program.

其次，你們的研發管線裡有一個項目，我開始對此感到非常興奮，這或許主要是因為它恰好屬於吉利德一直非常擅長的領域——新型核苷（酸）合成酶 GS-9131，它可以成為生命週期管理的基礎。我注意到這次的幻燈片裡沒有提到，我想問您能否為我們介紹一下那個專案有哪些收穫。

Terrific, Umer. So we're going to start with John in filgo, and then we'll go to Diana for HIV question.

太棒了，烏默。所以我們先從約翰在filgo的提問開始，然後我們再來請戴安娜回答關於愛滋病毒的問題。

Sure. Umer, I mean, as you know, and we've spoken of before, we know that patients with inflammatory diseases are at risk for thrombosis. And so it's always a comparison against expected background rates of this event in patients. And we think it's possible that selected JAK1 inhibition, as we have with filgotinib, may have some advantages. But certainly at this point, it would be premature to speculate on what the label outcomes may be. We're going to go through the process. We believe we have a strong story with regard to thrombosis risk and at the same time, reassured by the overall efficacy and safety profile. So we've seen this across all of our programs, and we are looking forward to having that discussion with the regulators.

當然。烏默，我的意思是，正如你所知，我們之前也談到過，我們知道患有發炎性疾病的患者有發生血栓的風險。因此，總是要與患者中該事件的預期背景發生率進行比較。我們認為，像使用filgotinib那樣選擇性地抑制JAK1可能具有一些優勢。但就目前而言，猜測唱片公司最終會做出怎樣的決定還為時過早。我們將按部就班地進行。我們相信，在血栓風險方面，我們有充分的理由，同時，整體療效和安全性也讓我們感到放心。我們在所有項目中都看到了這種情況，我們期待與監管機構進行討論。

This is Diana Brainard. I'll speak to your question around GS-9131, which is a nucleotide reverse transcriptase inhibitor with an improved resistance profile over the currently improved drugs in that class. And this is a compound that we've been excited about and moving through the clinic in early phase studies because we do have a commitment to highly treatment-experienced patients who have failed higher regimens and have multidrug resistance. In parallel with the GS-9131 program, as you know, our capsid inhibitor program with GS-6207 has also progressed very rapidly. And GS-6207 is the first-in-class compound. It's got a novel mechanism of action. It's got an orthogonal resistance profile. We haven't seen any pre-existing resistance among all of the samples we've tested from treatment-naïve patients and heavily treatment-experienced patients. These data have been published at recent conferences. And so because of this novel mechanism of action, because of the potency, because of the lack of pre-existing resistance, we really feel that the capsid inhibitor is the really best and lead compound to bring forward in highly treatment-experienced patients. And in fact, its promise was recognized by FDA when they granted us breakthrough designation for this population. And so we're moving ahead with capsid in this population into a registrational trial. And therefore, won't be bringing GS-9131 forward for this population because we prioritized our capsid inhibitor.

這是戴安娜·布雷納德。我將回答你關於 GS-9131 的問題，它是一種核苷酸逆轉錄酶抑制劑，與目前該類藥物相比，其抗藥性有所提高。我們一直對這種化合物感到興奮，並正在推進其早期臨床試驗，因為我們致力於為那些接受過多種治療但均告失敗且具有多重抗藥性的患者提供服務。如您所知，與 GS-9131 專案並行，我們的衣殼抑制劑專案 GS-6207 也取得了非常迅速的進展。GS-6207 是同類首創的化合物。它具有一種全新的作用機制。它具有正交電阻特性。在我們測試的所有樣本中，無論是未經治療的患者還是接受過大量治療的患者，都沒有發現任何預先存在的抗藥性。這些數據已在近期會議上發表。因此，由於這種新穎的作用機制、強大的效力以及缺乏預先存在的抗藥性，我們真的認為衣殼抑制劑是目前最好的先導化合物，值得在接受過大量治療的患者中推廣使用。事實上，FDA 認可了這項技術的潛力，並授予我們針對該族群的突破性療法認定。因此，我們將推進該人群中衣殼的註冊試驗。因此，我們不會為該族群推出 GS-9131，因為我們優先考慮了衣殼抑制劑。

Our next question comes from the line of Mohit Bansal with Citigroup.

我們的下一個問題來自花旗集團的 Mohit Bansal。

So looking at your slides, you have some plans to develop capsid inhibitor in the Phase II -- started trial in Phase II trial with capsid inhibitor. Have you discussed internally about what kind of combination agent you will be using for this long-acting treatment at this point? And when can we learn more about your PrEP strategy for capsid inhibitor?

從你的幻燈片來看，你有一些計劃在 II 期臨床試驗中開發衣殼抑制劑——已經開始了衣殼抑制劑的 II 期臨床試驗。你們內部是否討論過目前將使用哪種合併用藥進行這種長效治療？我們什麼時候可以了解更多關於您針對衣殼抑制劑的暴露前預防（PrEP）策略？

Sure. So we're really envisioning the capsid inhibitor to have multiple different applications for people living with HIV. I just mentioned its use for heavily treatment-experienced patients where it could be added on to optimize background therapy as is commonly done for this population. But it also has a huge potential for people living with HIV who might want to switch to a long-acting regimen because of its ability to be given at least every 3 months, every 6 months and, potentially in the future, longer. And there, we are still actively looking for what the right partner for our capsid inhibitor will be, and we have multiple internal programs, which are preclinical or in the very earliest stage of assessment in the clinic. And we're looking forward to sharing more details as we have more certainty about what the right combination will be to partner with capsid. What we're prioritizing is ease of administration. So we're looking at subcutaneously administered drugs. We're looking at drugs that can go the distance in terms of longer, at least monthly, if not longer and match capsid's potential. And so as we prioritize those features and bring forward different compounds, we'll -- we're really excited actually to share that data.

當然。因此，我們設想衣殼抑制劑能夠為愛滋病毒感染者提供多種不同的應用。我剛才提到過，它可以用於治療經驗豐富的患者，可以像通常對這類患者那樣，將其添加到背景治療中以優化治療方案。但它對於可能想要改用長效療法的 HIV 感染者來說也具有巨大的潛力，因為它至少可以每 3 個月、每 6 個月服用一次，而且將來可能服用時間更長。目前，我們仍在積極尋找合適的衣殼抑制劑合作夥伴，並且我們有多個內部項目，這些項目處於臨床前階段或處於臨床評估的早期階段。我們期待在更確定與 capsid 合作的最佳組合後，分享更多細節。我們優先考慮的是管理的便利性。所以我們現在關注的是皮下注射藥物。我們正在尋找能夠持續更長時間（至少每月一次，甚至更長）並能與衣殼蛋白的潛力相匹配的藥物。因此，當我們優先考慮這些特性並推出不同的化合物時，我們——我們真的非常興奮地想要分享這些數據。

Our next question comes from Cory Kasimov with JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

I wanted to see if you could talk a little bit more about the quarter-over-quarter trends for Yescarta. I know you mentioned there are -- or there were a higher number of potential patients going into clinical trials in 3Q, but how much do you think this sequential drop can also be attributed to the launch of Polivy? Are you seeing center slot that in the head of CAR T products or potentially any other dynamics taking place?

我想請您再詳細談談 Yescarta 的季度環比趨勢。我知道您提到第三季度有更多潛在患者參與臨床試驗，但您認為這種連續下降在多大程度上也可以歸因於 Polivy 的上市？您是否在 CAR T 產品頭部看到了中心槽，或者可能存在其他動態變化？

Yes. Absolutely, Cory. No, thanks for the question. Happy to talk about it. I mean, I think it is important that I start out with letting you know that the team here is really confident with the longer-term opportunity of Yescarta and also cell therapy. But as we know, I mean, this is a pioneering platform and just to point out some of the dynamics that we're seeing in the market, cell therapy really literally changes everything that it touches, from patient identification to clinical practice, to reimbursement, to safety management. So I would say some of the growing challenges with getting a pioneering technology in are what we would expect. But what's kind of questionable is in the patient set where it has been studied, so relapsed/refractory DLBCL so far in the market, I mean, the efficacy and durability are unprecedented. I mean, the majority of extremely sick patients who are alive at 2 years. And as we know, and many of my colleagues and the team, hematology/oncology is a data-driven space. So I would say that -- and we also have a very strong and good manufacturing capacity, which is critical for this technology.

是的。當然，科里。不，謝謝你的提問。我很樂意談論這個話題。我的意思是，我認為首先要讓大家知道，我們團隊對 Yescarta 和細胞療法的長期前景非常有信心。但正如我們所知，這是一個開創性的平台，為了指出我們在市場上看到的一些動態，細胞療法確實改變了它所觸及的一切，從患者識別到臨床實踐，再到報銷和安全管理。所以我認為，在引入一項開創性技術的過程中，一些日益增長的挑戰是我們預期的。但值得質疑的是，就目前市面上針對復發/難治性瀰漫性大B細胞淋巴瘤（DLBCL）患者所進行的研究而言，其療效和持久性是前所未有的。我的意思是，絕大多數重症患者在兩年後仍然存活。正如我們以及我的許多同事和團隊成​​員所知，血液學/腫瘤學是一個數據驅動的領域。所以我想說——而且我們還擁有非常強大且良好的製造能力，這對這項技術至關重要。

Now you mentioned some of the challenges. Let me talk about some of the drivers and some of the challenges that we're seeing in general in the market. I mean, on the positive side, the NTAP improvement that just went into effect in October 2019 from a reimbursement by CMS of 50% to 65% is a step in the right direction. We -- it does take -- there is a lag time before that gets fully absorbed and introduced into the community. I would point out the ASH data coming up. We'll have 3 key events there: the survival data at 3 years in relapse/refractory DLBCL; early steroid use; and also data on the KTE-X19 in MCL. Would just also point out the ZUMA-7 is now fully enrolled. So that's the second line DLBCL. I look forward to that trial playing through. And hopefully, as we go into next year, we can look towards a DRG for CAR T as well.

你剛才提到了一些挑戰。讓我談談目前市場中普遍存在的一些驅動因素和挑戰。我的意思是，從積極的方面來看，2019 年 10 月生效的 NTAP 改進措施，將 CMS 的報銷比例從 50% 提高到 65%，是朝著正確方向邁出的一步。確實，這需要一段時間才能完全吸收並引入社區。我想指出即將出現的 ASH 數據。我們將有 3 個關鍵事件：復發/難治性 DLBCL 的 3 年存活數據；早期類固醇使用；以及 MCL 中的 KTE-X19 數據。另外也要指出，ZUMA​​-7 目前已全部招滿。所以這是第二行 DLBCL。我期待這場審判的進行。希望明年我們也能期待 CAR-T 的 DRG 分類。

So those are some of the real positive things we're seeing in the market and then to your point, I mean, there are still challenges with Medicare reimbursement update. There is a high rate of clinical trial usage in DLBCL, which is good news for patients. It's just -- there's quite a few clinical trials there still getting the patient referral flow-downs. We do have some new market entrants, early days on those. You mentioned one on the call here today and this whole concept between inpatient and outpatient reimbursement. So I think, the team is kind of systematically working through these and that's why we see some quarter-on-quarter fluctuation in the United States.

所以這些是我們在市場上看到的一些真正積極的方面，至於你提到的，我的意思是，醫療保險報銷更新方面仍然存在挑戰。DLBCL 的臨床試驗使用率很高，對病人來說是個好消息。只是──那裡還有相當多的臨床試驗仍在進行病患轉診流程。我們確實有一些新的市場進入者，但目前還處於早期階段。您今天在電話會議上提到了這一點，以及住院和門診報銷之間的整個概念。所以我認為，團隊正在有條不紊地解決這些問題，這就是為什麼我們看到美國市場出現了一些季度環比波動。

I would point out that we're now getting going in Europe, which is also terrific and very good growth there and different -- some of these dynamics are different in Europe as well. So I think, as we learn quarter-to-quarter on some of the dynamics and as the data matures and develops out there, I think that's going to be a real telltale sign for how we continue to see the uptake here. But taking a big step back, the type of data we're seeing and the duration of response in the patients that we've studied is second to none. So hopefully, as some of this becomes more -- the trends become more clear in future quarters, we'll be able to be more precise about some of these as well, but thanks for the question, Cory.

我想指出的是，我們現在在歐洲也開始發展，那裡的成長也非常好，而且情況有所不同——歐洲的一些動態也與其他地方不同。所以我認為，隨著我們每季對一些動態的了解，以及數據的成熟和發展，我認為這將成為我們如何繼續看到這裡市場接受度提升的一個真正明確的標誌。但從更宏觀的角度來看，我們所看到的數據類型以及我們研究的患者的反應持續時間都是首屈一指的。所以，希望隨著未來幾季趨勢的逐漸明朗，我們也能對其中一些情況做出更精確的判斷。謝謝你的提問，科里。

Our next question comes from Salim Syed with Mizuho.

下一個問題來自瑞穗銀行的Salim Syed。

Congrats to Robin, and welcome to Andy. Just one for me on hepatitis B, as in boy, if I can. I mean, if you guys can give us an update on the core inhibitor, what's the status there? I know there's been some safety issues for the core inhibitor class, predominantly coming from HAV and SBA derivatives. So I was wondering if you can just give us a little bit of color if your core inhibitor whether it is in development or not in development and whether it is one of those derivatives?

恭喜 Robin，歡迎 Andy 加入。如果可以的話，我只想找一個患有B肝的男孩。我的意思是，如果你們能給我們更新核心抑制劑的進展情況，那它現在的狀態如何？我知道核心抑制劑類藥物存在一些安全性問題，主要來自 HAV 和 SBA 衍生物。所以我想請您簡單介紹一下您的核心抑制劑，它是否正在研發中，以及它是否是那些衍生物之一？

Salim, this is Diana Brainard. Are you talking about the capsid inhibitor?

薩利姆，這位是戴安娜·布雷納德。您說的是衣殼抑制劑嗎？

For hepatitis B, as in boy.

例如男孩患乙型肝炎。

Yes. You're talking about the capsid inhibitor? Yes.

是的。你指的是衣殼抑制劑嗎？是的。

Yes, the capsid. Yes, correct. Yes.

是的，是衣殼。是的，沒錯。是的。

Yes. So I think that we have seen the competitor data regarding capsid, and we're looking very closely at our compounds preclinically as well as clinically. Because, obviously, with hepatitis B, we've got a lot of experience in this space, and we know very well the value of suppressive treatment and the safety of those regimens and the benefit that viral suppression brings in terms of reducing cirrhosis, reducing rates of hepatocellular carcinoma. So while we're committed to cure and recognize that we're going to need combination therapies, we're also really cognizant of the safety barrier that really has to be exceeded to bring combinations forward. And I think that's really all we can say about that right now.

是的。所以我認為我們已經看到了有關衣殼的競爭對手數據，我們正在臨床前和臨床上非常密切地研究我們的化合物。因為很顯然，在B型肝炎方面，我們有很多經驗，我們非常清楚抑制治療的價值和這些方案的安全性，以及病毒抑制在減少肝硬化、降低肝細胞癌發病率方面帶來的益處。因此，雖然我們致力於治癒疾病，並且認識到我們需要聯合療法，但我們也非常清楚，要推進聯合療法，必須克服一定的安全障礙。我想，目前我們只能說這麼多了。

Are you still developing? Is it still ongoing -- there's been some speculation that it's been terminated in the marketplace.

你還在開發嗎？該項目是否仍在進行中？有傳言稱該項目已在市場上終止。

I think that we're in the process of continually evaluating what our best next steps are. And I think in terms of how we prioritize what we bring forward, we've got the TLR8 in Phase II, and we really want to see the results of those studies before making any final decisions on next steps and future combinations.

我認為我們正在不斷評估下一步的最佳措施是什麼。我認為，就我們如何確定推進計畫的優先順序而言，TLR8 目前處於 II 期臨床試驗階段，我們非常希望在對下一步措施和未來組合方案做出最終決定之前，先看到這些研究的結果。

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

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

Just one question on filgotinib. Maybe to ask Umer's question a different way. You've talked a lot about differentiating filgotinib. How important is a differentiated label to that process commercially? How else -- what other key points will you have in differentiating filgotinib?

關於filgotinib，我只有一個問題。或許可以換個方式問烏默的問題。您多次談到了區分filgotinib。從商業角度來看，差異化標籤對這過程有多重要？還有什麼其他方法——您認為在區分filgotinib方面還有哪些關鍵點？

And then a second filgotinib question. We had been expecting data from filgotinib as well as GS-9876 in Sjogren's and CLE in the second half this year. I noticed in your slides, neither of those programs are mentioned. Is there any update on those 2 Phase II programs?

然後是關於filgotinib的第二個問題。我們原本預計今年下半年會公佈filgotinib和GS-9876在乾燥症和慢性紅斑性狼瘡的數據。我注意到你的幻燈片中沒有提到這兩個項目。那兩個二期項目有最新進展嗎？

Yes. I'll let -- Johanna can start on the commercial side, Phil, and then we'll go to John on the development.

是的。我先讓 Johanna 負責商業方面，Phil，然後我們再讓 John 負責開發方面。

Okay. So Phil, more on the competitive concept. So, as you know, this environment is super competitive and many of us know it well, including myself. And so we've really pulled together a team that has considerable experience in this field. The piece that you would say that the differentiated label, I think, it's twofold. I think from a label standpoint what we've seen thus far from the FDA is a little bit of a -- more of a class labeling. And so our expectations -- and we'll go through the process, but we're also being conservative in our expectations.

好的。那麼菲爾，我們再來談談競爭的概念。如你所知，這個環境競爭非常激烈，我們很多人都深有體會，包括我自己。因此，我們組建了一支在該領域擁有豐富經驗的團隊。我認為，你所說的差異化標籤，有兩方面的原因。我認為從標籤的角度來看，我們目前從 FDA 看到的更像是類別標籤。因此，我們的預期——我們會經歷這個過程——但我們的預期也比較保守。

One of the things that I would say is the importance of our data. And I think that if you look at the results of the 3 FINCH 3 studies in 3 different patient groups, those are really exciting for us, both from an efficacy standpoint as well as a safety standpoint. So a lot of the work that's being done right now is subanalysis to ensure that we can better educate physicians about our data. So that's kind of the plan there. And I do think that the opportunity here is to potentially have a best-in-class JAK inhibitor and that could be also related to the selectivity of the JAK1. So having said that, that's what we're doing. All hands are on deck to prepare for a competitive launch but a differentiated one and an innovative one at the same time. So we're excited about that and obviously, we'll know more about the label in the coming months through 2020. So John, maybe on the other?

我想強調的一點是，我們的數據非常重要。我認為，如果你看一下 FINCH 3 在 3 個不同患者群體中的 3 項研究的結果，無論從療效角度還是安全性角度來看，這些結果都讓我們感到非常興奮。因此，目前正在進行的大量工作是子分析，以確保我們能夠更好地向醫生講解我們的數據。這就是大致的計劃。我確實認為，這裡的機會在於有可能研發出一流的 JAK 抑制劑，而這可能也與 JAK1 的選擇性有關。所以，綜上所述，這就是我們正在做的。所有人員都已就緒，準備迎接一場既具有競爭力又與眾不同、同時又具有創新性的產品發布。所以我們對此感到興奮，顯然，在接下來的幾個月裡，直到 2020 年，我們會對這個品牌有更多了解。所以約翰，或許在另一個地方？

Sure. Let me update you on the status of the cutaneous lupus and Sjogren's studies that we conducted. So these were proof-of-concept studies. As you probably know, we looked at a couple or even 3 different drugs in the same trials for these. These studies were exploratory in nature. We set a high bar for ourselves to proceed. And while we did not see or meet the primary endpoint in these studies, a thing that I would like to point out is that we did see evidence of activity with filgotinib, particularly in patients who had markers or evidence of more active disease. So we just got the first look at these data, we're looking at the full set of data from all of these studies, and we'll determine the next steps that we take in lupus and Sjogren's disease and we'll share those results at an upcoming meeting soon.

當然。讓我向您報告我們所進行的皮膚狼瘡和乾燥症研究的最新進展。所以這些都是概念驗證研究。您可能知道，我們在同一項試驗中研究了兩種甚至三種不同的藥物。這些研究本質上屬於探索性研究。我們為自己設定了很高的目標。雖然我們在這些研究中沒有看到或達到主要終點，但我想指出的是，我們確實看到了filgotinib的活性證據，尤其是在那些有更活躍疾病標記或證據的患者中。所以我們剛剛初步了解了這些數據，我們正在查看所有這些研究的完整數據集，我們將確定在狼瘡和乾燥綜合徵方面採取的下一步措施，我們將在即將召開的會議上分享這些結果。

Our next question comes from Evan Seigerman with Crédit Suisse.

我們的下一個問題來自瑞士信貸的埃文·塞格曼。

I also want to extend my best wishes to Robin on her retirement. Just one on the Kite franchise. So I'm just wondering if you can help me better understand the rationale for the increased investment, namely with the manufacturing facility. But more broadly, how is expansion into cell therapy beyond Yescarta fit within your kind of new strategy for Gilead, Dan? And aside from Yescarta, are there any programs that you should think we should focusing on that could drive near-term value for the franchise?

我也想向羅賓致以最美好的退休祝福。Kite系列遊戲裡只有一款。所以我想知道您能否幫我更能理解增加投資的理由，特別是對製造工廠的投資。但更廣泛地說，丹，除了 Yescarta 之外，將業務拓展到細胞療法領域，如何契合吉利德的新策略？除了 Yescarta 之外，您認為我們應該專注於哪些項目，以便在短期內為特許經營帶來價值？

Thanks very much for the question. And -- yes, again, I would probably start with the investments that you mentioned. I mean, I think it's really important that we acknowledge the fact that the ability to manufacture and the turnaround time associated with cell therapy is absolutely fundamental to patient benefit and also to the efficacy results that we're seeing. And I think it's a real competitive advantage to be able to have now a network of manufacturing facilities that are state-of-the-art and are able to reduce that turnaround time, including as you mentioned, we have made a decision to establish a viral vector facility in one of our current manufacturing sites in Oceanside, California that will allow us to not only support the current products, but also future products in the pipeline. So, look, I mentioned some of the nearer-term things on CAR T in addition to what we currently have out there with the Yescarta profile today. This data on Yescarta at ASH I think will be important, looking at the 3-year data and the early steroid use. The Kite X19 is now a second product for MCL, and we look forward to presenting that data as well. ZUMA-7 goes back to Yescarta in an earlier line sitting. So when you think about the long duration of effect, the efficacy and durability that we've seen in the relapsed/refractory third line setting, I mean, the real question is, and the more natural, obviously, oncology development avenue is can you is to say can you bring that effect up into earlier lines of therapy and potentially have this effect with more patients and potentially for longer duration because you're treating them earlier.

非常感謝您的提問。是的，我可能還是會從你提到的那些投資開始。我的意思是，我認為我們必須認識到，細胞療法的生產能力和周轉時間對於患者的益處以及我們所看到的療效結果來說，都是至關重要的。我認為，能夠擁有一個最先進的生產設施網絡，從而縮短週轉時間，這確實是一個競爭優勢。正如您所提到的，我們已經決定在加州 Oceanside 的一個現有生產基地建立一個病毒載體生產設施，這將使我們能夠不僅支援現有產品，還能支援未來正在研發的產品。所以，你看，除了我們今天在 Yescarta 簡介中提到的內容之外，我還提到了一些關於 CAR T 的近期計劃。我認為ASH上關於Yescarta的數據非常重要，需要關注3年的數據以及早期類固醇的使用。Kite X19 現在是 MCL 的第二款產品，我們期待展示相關數據。ZUMA-7 回到 Yescarta，參加了之前的排隊活動。所以，當你考慮到這種療法在復發/難治性三線治療中展現出的持久療效、有效性和耐久性時，我的意思是，真正的問題是，更自然、更明顯的腫瘤學發展途徑是，能否將這種療效帶到更早期的治療階段，並有可能使更多患者受益，且療效持續時間更長，因為你更早地對他們進行了治療。

So the strategy is very much to continue to expand out the hematology indications first and foremost. I think that's where the greatest products exist for CAR Ts right now, but we do also have mid- to longer-term programs on solid tumors, on allogeneic and those, although risker and earlier, are also programs we are fully committed to as we look to round out our leadership in cell therapy accordingly.

因此，我們的策略是先繼續擴大血液疾病適應症。我認為目前CAR-T療法的最佳產品就在這裡，但我們也有針對實體瘤和同種異體腫瘤的中長期項目，雖然這些項目風險更高、起步更早，但我們也全力投入其中，以期鞏固我們在細胞療法領域的領先地位。

So more to come on this. I, personally to the broader oncology strategy. I mean, as I've said before and I'll say it again, I think the concept of Gilead getting deeper into oncology by starting with a pioneering technology I think is a smart thing to do in oncology. I mean, really to think about where you can get long durations of responses with a new technology. Having said that, we also have a great deal of expertise in our home-base technologies, such as small molecules and an evolving biologic modality expertise at Gilead. And although I'm not prepared to talk more about that today and look forward to Merdad and others coming into the organization so that we can continue to evolve our oncology strategy, I think there are opportunities, certainly, that we can look at outside of cell therapy and complementary to cell therapy. So more on that. So we are literally in the process of really doing deep dives on this. As you know, we also have some partnerships with other companies where we are fully committed to different aspects of oncology. And it's been a common question and I totally accept it, if it's one that as we go into next year, we'll be laying out deeper and deeper our holistic strategy around oncology that will include cell therapy, but not be only cell therapy as we move ahead. So more to come on that.

關於此事，後續還有更多內容。我個人更傾向於更廣泛的腫瘤治療策略。我的意思是，正如我之前所說的，我還要再說一遍，我認為吉利德透過一項開創性技術深入腫瘤學領域的做法，在腫瘤學領域是一件明智的事情。我的意思是，要認真思考一下，利用新技術可以在哪些方面獲得長時間的回應。話雖如此，我們在本土技術領域也擁有豐富的專業知識，例如小分子藥物和吉利德不斷發展的生物製劑技術。雖然我今天不打算就此多談，也期待著 Merdad 和其他人加入公司，以便我們能夠繼續發展我們的腫瘤學策略，但我認為，當然，在細胞療法之外，以及與細胞療法互補的領域，我們還有一些機會可以考慮。關於這一點，我們再多說一些。所以我們正在對這個問題進行深入研究。如您所知，我們也與其他一些公司建立了合作關係，我們全力致力於腫瘤學的各個方面。這是一個常見的問題，我完全接受這個問題。展望明年，我們將越來越深入地制定我們圍繞腫瘤學的整體策略，其中將包括細胞療法，但隨著我們前進，細胞療法將不再是唯一的療法。關於這一點，後續還會有更多討論。

Next question comes from the line of Tyler Van Buren with Piper Jaffray.

下一個問題來自泰勒·範·布倫和派珀·傑弗裡這一組。

Earlier in the session, you guys spoke towards your strategic areas of focus for business development and the Galapagos deal makes a lot of sense from a long-term, broadening out the pipeline perspective and acquiring additional scientific talent in Europe. But could you guys to speak a little bit further to your urgency to acquire late-stage or on-market assets, particularly maybe within the next year to add to the top line, which as it stands is relatively flat?

在會議早些時候，你們談到了業務發展的戰略重點領域，從長遠來看，加拉巴哥群島的交易很有意義，它拓寬了產品線，並在歐洲獲得了更多的科學人才。但你們能否再詳細談談你們為何如此迫切地想要收購後期或在市場上的資產，尤其是在未來一年內，以增加目前相對平穩的營收？

So thanks, Tyler. I mean, obviously, we're a company that's firmly focused on differentiated medicines and will be driven, again, by the science, both internally and externally. And obviously, it won't be too long before we start to talk about the guidance for 2020 and beyond, and I'm not going to talk about that today. But the bottom line is we're -- if I take a big step back and I think about my confidence in the long-term growth potential of Gilead, it is captured within the strength of the HIV business. I mean, that same business that you see offsetting some of the patent expiry this year continues to be, we think, a very durable business for the foreseeable future. You have a more predictable HIV-HCV business at this time. And then we have upside potential in filgotinib launching next year, and I won't repeat, but the Yescarta programs and successes accordingly. Having said that, we understand that we want to find ways to continue to look to increase and accelerate our growth in the coming years. And that will happen both through internal strategies associated with the launch products and the programs I mentioned and then also outside partnerships and M&A. So rest assured that we are looking at everything that could help complement our later-stage portfolio out there. And yet, and as you've seen, I think, our behaviors, we will be disciplined about that. We will make sure that it's something that we feel scientifically is very strong, something that we can add something to and provide strength to. And when and if those opportunities come up, we certainly have the financial capacity and ability to act. So that's paramount on our mind. We are in it for the short, medium, long-term and we're looking to improve all 3 of those time periods. But clearly, the portfolio is absolutely a key for me and a key for the leadership team. So thank you, Tyler, for your question.

謝謝你，泰勒。我的意思是，很顯然，我們是一家堅定專注於差異化藥物的公司，並且將再次以科學為驅動力，無論是在內部還是外部。顯然，不久之後我們就會開始討論 2020 年及以後的指導方針，但我今天不打算談論這個主題。但歸根結底，如果我退後一步，思考我對吉利德長期成長潛力的信心，那就是吉利德愛滋病業務的實力。我的意思是，我們認為，那些能夠抵消今年部分專利到期影響的業務，在可預見的未來仍然會是一個非常持久的業務。目前您的愛滋病毒/C型肝炎業務更加穩定。然後，filgotinib 明年上市，我們有很大的上漲潛力，我就不贅述了，Yescarta 計畫及其取得的成功也同樣如此。話雖如此，我們也明白我們需要找到方法，在未來幾年繼續尋求增加和加速成長。這既可以透過與產品發布和上述項目相關的內部策略來實現，也可以透過外部合作和併購來實現。所以請放心，我們正在關注所有可能有助於完善我們後期投資組合的事物。然而，正如你所看到的，我認為，我們會在這方面保持自律。我們會確保它是我們認為在科學上非常可靠的，是我們可以加以改進和加強的東西。如果這些機會出現，我們當然有足夠的財力和能力去把握。所以這是我們最關心的問題。我們著眼於短期、中期和長期，並希望在所有這三個時間段內都取得進步。但很顯然，投資組合對我以及領導團隊來說都至關重要。謝謝你的提問，泰勒。

That will conclude today's question-and-answer session. I'd like to turn the call back to Sung Lee for closing remarks.

今天的問答環節到此結束。我想把電話轉回給李成，請他作總結發言。

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

謝謝你，莉茲，也謝謝今天所有到場的各位。我們感謝您一直以來對吉利德的關注，我們的團隊期待向您報告我們未來的進展。

Ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.

女士們，先生們。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。