吉利德科學 (GILD) 2019 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences' Second 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年第二季財報電話會議。我叫莉茲，今天我將擔任你們的會議接線生。（操作員說明）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 second 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 年第二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; Johanna Mercier, Chief Commercial Officer; and Robin Washington, Executive Vice President and Chief Financial 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；首席商務官喬安娜·默西埃；以及執行副總裁兼財務長羅賓·華盛頓。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 will now turn the call over to Dan.

現在我將把通話交給丹。

Well, thank you, Sung, and good afternoon, everyone. It's now month 5, and I'm really pleased that I've had the -- a chance now to talk with you the second time in the second quarter after the first quarter call with some very good results.

謝謝你，宋，大家午安。現在已經是第五個月了，我很高興有機會在第二季第二次與您交談，這是繼第一季電話會議之後取得的一些非常好的結果。

I'd like to share a few opening comments, and then I'm going to turn the call over to Johanna Mercier, who joined us at the beginning of the month as our new Chief Commercial Officer. Very happy to have Joanna with us as well. Robin will then take over and walk you through some of the highlights of the strong quarter.

我想先發表一些開場白，然後我會把電話交給本月初加入我們擔任商務長的 Johanna Mercier。非常高興喬安娜也能加入我們。接下來，羅賓將接手，帶您了解本季的一些亮點。

So let me just start by saying I'm really pleased with the progress we're making across all the fronts. As one example, as the leader in HIV, we're very focused on continuous innovation as you may have seen from some of the recent data we presented. Biktarvy is the #1 regimen in the United States now. Momentum continues to build, and we expect that momentum to continue in the future.

首先我想說的是，我對我們在各個方面取得的進展感到非常滿意。舉例來說，作為愛滋病領域的領導者，我們非常注重持續創新，正如您可能從我們最近展示的一些數據中看到的那樣。Biktarvy現在是美國排名第一的美容療法。勢頭持續增強，我們預計這種勢頭將在未來繼續保持。

I mentioned on the last quarter that I would focus on 3 key priorities as I came into this organization: The first one was the pipeline; the second one was optimal commercial delivery, that's both for our current products but also as we prepare for some new and important and exciting launches; and then thirdly, really people. The organization, bringing the right team together at the right time for Gilead.

我在上個季度提到過，我加入這個組織後將專注於 3 個關鍵優先事項：第一是產品線；第二是最佳的商業交付，這既包括我們目前的產品，也包括我們為一些新的、重要的、令人興奮的產品發布所做的準備；第三，就是人才。該組織在合適的時間為吉利德組建了合適的團隊。

And as you can see, we've had a very busy quarter. We've announced key changes this quarter that helped to address really all 3 of these priorities. And importantly, we've made these changes against a backdrop of strong financials and really promising pipeline progress.

正如你所看到的，我們這個季度非常忙碌。本季我們宣布了一些關鍵變化，這些變化有助於真正解決這三個優先事項。更重要的是，我們是在財務狀況良好、產品研發進展非常順利的背景下做出這些改變的。

So let me say a few words about the major steps we've taken to: first of all, strengthen the pipeline with the Galapagos collaboration; secondly, I want to dive a little bit into the highlights from our current pipeline; and three, talk a little bit about the organizational changes as well.

那麼，我想就我們採取的主要步驟談幾句：首先，加強與加拉巴哥群島的合作；其次，我想重點介紹一下我們目前合作計畫的亮點；第三，也想談談組織方面的變革。

So first, on Galapagos. It's fresh news. Earlier this month, we announced an exciting new collaboration with Galapagos. As you know, Galapagos is a highly productive R&D engine. They have 7 medicines now in clinical development, including filgotinib, which has a very comprehensive of life cycle program. And they have more than 20 medicines now in preclinical and their model has been very productive at producing new candidates for the clinic every year. And of course with our increased investments, we would expect that to even increase in the future.

首先，我們來談談加拉巴哥群島。這是最新消息。本月初，我們宣布與加拉巴哥群島展開令人興奮的新合作。如您所知，加拉巴哥群島是一個高效率的研發基地。他們目前有 7 種藥物處於臨床開發階段，其中包括 filgotinib，該藥物擁有非常全面的生命週期計劃。他們目前有 20 多種藥物處於臨床前研究階段，他們的模式每年都能有效率地產生新的候選藥物進入臨床試驗。當然，隨著我們投資的增加，我們預計未來這一數字還會繼續成長。

This is a really unique collaboration because it combines complementary strengths between Gilead and Galapagos and very importantly, and as you know, we structured this to allow Galapagos to remain independent. Many of you know my past, I'm a big believer that innovation requires independence, I think, to be preserved. And the structure of this deal allows us to preserve the great science and talent at Galapagos. They can invest and innovate to accelerate the progress based upon our investments. And in return, we have an exclusive access right to their proven drug discovery platform. All of this, I believe, will help patients, science and our business in a very significant way.

這是一項非常獨特的合作，因為它結合了吉利德和加拉巴哥之間的互補優勢，而且非常重要的是，正如您所知，我們建立了這種合作模式，使加拉巴哥能夠保持獨立性。你們很多人都了解我的過去，我堅信創新需要獨立性才能維持。這項協議的結構使我們能夠保護加拉巴哥群島的偉大科學和人才。他們可以根據我們的投資進行投資和創新，從而加速發展進程。作為回報，我們獲得了獨家使用其成熟的藥物發現平台的權利。我相信，所有這些都將對患者、科學和我們的業務產生非常重要的影響。

So I was really pleased this was the first collaboration that I could announce under my tenure and yet, this is still a beginning. We'll continue to explore other ways to strengthen our pipeline and our innovation network in the future.

所以，我非常高興這是我任期內能夠宣布的第一個合作項目，但這仍然只是一個開始。未來，我們將繼續探索其他方法來加強我們的產品線和創新網絡。

Secondly, on the pipeline side, this has been an important time for our existing pipeline. Let me touch on a couple of things that speak to our growth potential before handing it over to Johanna. And there's 2 things I want to just highlight here: some recent promising HIV data that we presented recently; and secondly, since the last quarter, our plans to file filgotinib for approval.

其次，就管道建設而言，這對我們現有的管道來說是一個重要的時期。在把發言權交給喬安娜之前，我想先談談幾個能體現我們成長潛力的面向。這裡我想重點介紹兩件事：一是我們最近公佈的一些有希望的 HIV 數據；二是自上個季度以來，我們計劃提交 filgotinib 的審批申請。

So first of all, we had a terrific week last week at the International AIDS Society Conference on HIV Science. We were able to present clinical data for our first-in-class HIV capsid inhibitor, the GS-6207. And as you saw, the early results support further development as a long-acting therapy that we think will really meet the needs of the community that we serve. And then we also presented further data on Descovy for PrEP, additional data that reinforces the profile of Descovy in the PrEP setting. And as you know, this is currently under regulatory view in the United States. And we also have plans to file Descovy for PrEP in the EU in the first half of 2020.

首先，上週我們在國際愛滋病協會愛滋病科學大會上度過了非常棒的一週。我們得以展示我們首創的 HIV 衣殼抑制劑 GS-6207 的臨床數據。正如你所看到的，早期結果支持進一步開發這種長效療法，我們認為這將真正滿足我們所服務社區的需求。然後，我們也展示了有關 Descovy 用於 PrEP 的更多數據，這些數據進一步強化了 Descovy 在 PrEP 環境中的圖像。正如您所知，這目前正在美國接受監管審查。我們也計劃在 2020 年上半年向歐盟提交 Descovy 用於 PrEP 的申請。

We are looking forward to the FDA advisory committee that will be held next week. And overall, we're encouraged by the government's engagement around HIV prevention in many forms. The advisory committee will be an important opportunity and provide an -- a forum for Gilead to talk about the benefits of Descovy in the prevention setting for a broad population of individuals at risk for HIV.

我們期待下週召開的FDA諮詢委員會會議。總的來說，我們對政府在愛滋病預防方面採取的各種措施感到鼓舞。諮詢委員會將是一個重要的機會，並為吉利德公司提供一個論壇，討論 Descovy 在預防 HIV 感染方面對廣大高風險族群的益處。

So secondly, on filgotinib, as you know now, based upon a meeting with the agency, we intend to file for U.S. approval for filgotinib later this year in rheumatoid arthritis based upon our discussions with the FDA. We will also be filing in the EU really imminently at this stage.

其次，關於filgotinib，正如您現在所知，根據與FDA的會議，我們打算在今年晚些時候根據與FDA的討論，向美國FDA申請filgotinib用於治療類風濕性關節炎的批准。我們很快也會在歐盟提交申請。

So overall, very good news on the path for filgotinib. I had the chance actually recently to attend the EULAR meeting, the Annual European Congress of Rheumatology in Madrid, so I could get a first-hand view of the enthusiasm among physicians and thought leaders about the profile of filgotinib and the potential it has to be a best-in-class among the JAK1 inhibitors.

總的來說，filgotinib 的研發之路傳來非常好的消息。最近我有機會參加了在馬德里舉行的歐洲風濕病學年會（EULAR），因此我可以親眼目睹醫生和思想領袖們對 filgotinib 的特性以及它成為 JAK1 抑製劑中最佳藥物的潛力的熱情。

Finally, then a few comments about the work we've been doing to build the right team for the future. I'm very pleased to welcome Johanna, who you'll hear from next; and Christi Shaw, who joins us from Eli Lilly. She will start as CEO of Kite on August 1.

最後，我想就我們為組建面向未來的合適團隊所做的工作談幾點看法。我非常高興地歡迎 Johanna（接下來您將聽到她的發言）和來自禮來公司的 Christi Shaw。她將於8月1日正式就任Kite的執行長。

And as you know, with Christi's arrival at Kite, Kite will become its own business unit, and we remain committed to accelerating the pipeline and maintaining our leadership position in cell therapy.

如您所知，隨著 Christi 加入 Ki​​te，Kite 將成為獨立的業務部門，我們將繼續致力於加速產品線開發，並保持我們在細胞療法領域的領先地位。

I'd also like to very much extend a thanks to 3 leaders who will be leaving Gilead. John McHutchison, Gregg Alton and Katie Watson. John, Gregg and Katie have all made tremendous contributions that helped to shape today's results that you're seeing and really, Gilead's progress over the past many years, decades, in fact. So I'd like to thank them as we transition the team forward for Gilead.

我還要向即將離開基列的三位領導人表達衷心的感謝。約翰·麥克哈奇森、格雷格·奧爾頓和凱蒂·沃森。John、Gregg 和 Katie 都做出了巨大的貢獻，幫助塑造了你們今天看到的成果，也真正推動了吉利德在過去多年、幾十年裡的發展。因此，在吉利德團隊向前過渡之際，我想對他們表示感謝。

So in closing, from my side, I just wanted to emphasize how increasingly optimistic I am about the future of Gilead and the potential that it has. This is a unique company. It's a company that cured hepatitis C and transformed HIV. I'm getting an up-close view of the unique strengths that made that possible. I'm looking forward to working with all the talented people at Gilead as we apply those strengths to the next wave of transformational advances in various diseases.

最後，我想強調的是，我對吉利德的未來及其潛力越來越樂觀。這是一家獨一無二的公司。這是一家治癒了C型肝炎並改變了愛滋病治療方式的公司。我正在近距離觀察促成這一切的獨特優勢。我期待與吉利德的所有優秀人才一起工作，我們將運用這些優勢，在各種疾病領域取得下一波變革性進展。

We're making great progress, and there's much more to come and I look forward to continuing to share more about my vision for the future later this year as I communicated. But as you can tell, I'm not waiting for that, we're implementing along the course of that strategy with many of the things that you've seen in this past quarter.

我們取得了巨大的進展，未來還有更多計劃，我期待在今年晚些時候繼續分享我對未來的願景，正如我之前所溝通的那樣。但正如你所看到的，我並沒有等待那個時候的到來，我們正在按照該戰略的進程實施，你在過去這個季度已經看到了許多這樣的例子。

So I'd like to thank all of our employees and partners around the world for their dedication and hard work that led to a successful quarter and whose commitment will continue to make us successful in the future.

因此，我要感謝我們世界各地的所有員工和合作夥伴，感謝他們的奉獻和辛勤工作，正是他們的付出才使我們取得了本季度的成功，他們的承諾也將繼續使我們在未來取得成功。

With that, I'd like to turn the call over to Johanna.

接下來，我想把電話交給喬安娜。

Thanks, Dan, and good afternoon, everyone. So although I'm only 1 month in, I've begun to get to know the company, the people, and I just want to say how impressed I've been by the talent and the strength of the team as well as what they've accomplished so far. And today, I wanted to take the opportunity to maybe highlight 2 areas that really caught my attention, both of which I believe are real growth opportunities moving forward for Gilead. Those are the strength of our HIV business, both in treatment as well as in prevention as well as the potential for filgotinib.

謝謝你，丹，大家下午好。雖然我才加入公司一個月，但我已經開始了解這家公司和這裡的人們，我只想說，我對團隊的才華和實力以及他們迄今為止的成就印象深刻。今天，我想藉此機會重點介紹兩個真正引起我注意的領域，我認為這兩個領域都是吉利德未來真正的成長機會。這就是我們在 HIV 業務方面的優勢所在，無論是在治療或預防方面，以及 filgotinib 的潛力。

So if we start with HIV. You'll hear from Robin describe in more detail our results for the quarter, but our HIV portfolio has never been stronger. Biktarvy continues to be a very impressive launch. It's on an incredible trajectory. It's just hit its first $1 billion quarter in the U.S. for Q2. It's now the #1 prescribed regimen in the U.S. for both naïve and switch patients as well as #1 for naïve in switch in Germany, in France and in Spain. We just got reimbursement in Italy and the U.K. in the last 2 months or so, so more to come on performance there.

所以，如果我們從愛滋病毒說起。稍後您將聽到 Robin 更詳細地介紹我們本季的業績，但我們的 HIV 產品組合從未如此強大。Biktarvy 的發布依然非常成功。它的發展軌跡令人驚嘆。該公司在美國的第二季銷售額剛突破10億美元大關。目前，該療法已成為美國初治患者和轉診患者的首選治療方案，也是德國、法國和西班牙初治轉診病患的首選治療方案。最近兩個月左右，我們陸續收到了義大利和英國的報銷款項，所以關於那裡的業績還有更多消息。

As Dan mentioned, we had a really strong showing last week at the International AIDS Society Conference, presenting research that really demonstrated the breadth of the scientific work across our pipeline from prevention to treatment to cure. This included a couple of new analyses of our DISCOVER trial for Descovy for PrEP. We really believe that Descovy could offer important safety advantages over Truvada as it shows superior safety for bone and renal as well as rapid onset and longer duration of preventative therapy than Truvada. These are really clinically meaningful to individuals, physicians and payers for 2 main reasons. Individuals at risk of HIV are not patients but they're generally healthy people. So therefore, the bar for safety among this population is just so much higher.

正如丹所提到的，上週我們在國際愛滋病協會大會上表現出色，所展示的研究成果真正體現了我們從預防到治療再到治癒的整個科研流程的廣度。其中包括我們對 Descovy 用於 PrEP 的 DISCOVER 試驗的幾項新分析。我們堅信，Descovy 比 Truvada 具有重要的安全優勢，因為它在骨骼和腎臟方面表現出更優異的安全性，並且起效更快，預防性治療持續時間更長。這對個人、醫生和支付者來說具有真正的臨床意義，主要原因有二。有感染愛滋病毒風險的人群並非患者，他們通常是健康人群。因此，這一群體的安全標準要高得多。

The second reason is the persistency on PrEP has increased actually similar to that, that what we're seeing in HIV treatment patients. In addition, younger people are initiating this therapy at the time when they're actually building peak bone mass. So overall, people on preventative therapy are on for longer periods of time, which is what makes these results even more compelling. And that's exactly what we heard from physicians at an ad board last week during the conference. So we're very excited about what's to come with Descovy in PrEP.

第二個原因是 PrEP 的持續使用率實際上有所提高，這與我們在 HIV 治療患者中看到的情況類似。此外，年輕人開始接受這種療法的時候，正是他們骨量達到高峰的時期。因此，總體而言，接受預防性治療的人接受治療的時間更長，這使得這些結果更具說服力。而這正是我們上週在會議期間從廣告委員會的醫生們那裡聽到的。所以我們對 Descovy 在 PrEP 領域的未來發展感到非常興奮。

Dan mentioned that we're under review with the FDA for the prevention of HIV. And for the reasons I've just shared, we really believe it has significant potential to make a difference in the life of a broad population of individuals at risk of HIV. So that's the first real growth opportunity, both in HIV treatment as well as in PrEP.

丹提到，我們正在接受美國食品藥物管理局 (FDA) 的審查，以評估我們預防愛滋病毒的功效。正因如此，我們堅信它具有巨大的潛力，能夠對廣大面臨愛滋病毒感染風險的人群的生活產生正面影響。所以，這是愛滋病治療和暴露前預防領域的第一個真正的成長機會。

The second one is around filgotinib. I really see tremendous potential in filgotinib and the teams, you can imagine, they're really hard at work in preparing the launch of this medicine. It's a high priority for me and the team and the whole organization. Although it's a very competitive space, and we know that, we truly have an opportunity to make a difference in the lives of people living with RA and potentially even other inflammatory indications as these are just such debilitating diseases.

第二個問題與filgotinib有關。我真的看到了filgotinib的巨大潛力，你可以想像，研發團隊正在非常努力地準備這款藥物的上市。這對我個人、團隊以及整個組織來說都是頭等大事。雖然這是一個競爭非常激烈的領域，我們也知道這一點，但我們確實有機會為患有類風濕性關節炎甚至其他發炎性疾病的人們的生活帶來改變，因為這些疾病都非常痛苦。

And yes, there are numerous treatments in the market for RA, however, many patients aren't actually helped by the therapies that are currently available.

是的，市面上有許多治療類風濕性關節炎的藥物，但是，許多患者其實並沒有從現有的療法中得到幫助。

The FINCH studies highlight the strong efficacy and tolerability results of filgotinib in different patient types. Filgotinib, a JAK1 specific inhibitor, could actually answer a clear unmet need in the marketplace for an efficacious and safe oral agent. So still to come on that and obviously, more to come on the filing in the second half of this year.

FINCH 研究突顯了 filgotinib 在不同類型的患者中具有良好的療效和耐受性。Filgotinib 是一種 JAK1 特異性抑制劑，它或許能夠滿足市場上對有效且安全的口服藥物的明顯未滿足需求。所以關於這一點還有待進一步討論，顯然，今年下半年還會有更多關於提交文件的資訊。

So with that, I really look forward to working with this great team to deliver on the promise of these medicines and to getting to speak with you in more detail in the near future. I just want to take a moment to thank everyone for such a warm welcome as I've arrived a month ago.

因此，我非常期待與這個優秀的團隊合作，兌現這些藥物的承諾，並期待在不久的將來與各位進行更詳細的交流。我想藉此機會感謝大家在我一個月前抵達時給予的熱情歡迎。

And now I'll turn the call over to Robin. Robin?

現在我把電話交給羅賓。羅賓？

Thank you, Johanna, and welcome. And good afternoon, everyone. As Dan said in his opening comments, we had a strong quarter led by our HIV franchise, predictable performance in HCV and continued growth of Yescarta.

謝謝你，喬安娜，歡迎你。大家下午好。正如丹在開場白中所說，我們本季業績強勁，這主要得益於 HIV 產品線的出色表現、HCV 產品線的可預測表現以及 Yescarta 的持續增長。

Total revenues for the second quarter were $5.7 billion with non-GAAP diluted earnings per share of $1.82. This compares to revenues of $5.6 billion and non-GAAP diluted earnings per share of $1.91 for the same period last year. Total revenues and non-GAAP earnings per share for the second quarter benefited from an approximately $160 million adjustment for statutory revenue clawback reserve, primarily related to HIV and HCV sales in Europe from prior years, which contributed $0.10 per share.

第二季總營收為 57 億美元，非 GAAP 稀釋後每股收益為 1.82 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 1.91 美元。第二季總收入和非GAAP每股收益受益於約1.6億美元的法定收入追回準備金調整，主要與往年歐洲的HIV和HCV銷售額有關，這貢獻了每股0.10美元。

Non-GAAP earnings per share for the same quarter last year benefited from a settlement of a tax examination, which contributed $0.15 per share.

去年同期非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。

So starting with HIV. Total HIV sales for the second quarter were $4 billion. In the U.S., HIV product sales for the second quarter were $3.2 billion, up 13% year-over-year and up 14% sequentially. The year-over-year increase was driven by robust underlying prescription demand growth, up 13%. This marks the fifth consecutive quarter in which HIV sales have posted double-digit year-over-year growth. And the first quarter in which Biktarvy surpassed the $1 billion mark, becoming the #1 prescribed regimen for all patients.

所以，先從愛滋病說起。第二季愛滋病毒產品總銷售額為 40 億美元。在美國，第二季愛滋病產品銷售額為 32 億美元，年增 13%，季增 14%。年成長主要得益於強勁的處方藥需求成長，成長了 13%。這是愛滋病產品銷售額連續第五個季度實現兩位數年成長。Biktarvy 在第一季銷售額就突破了 10 億美元大關，成為所有患者處方量排名第一的治療方案。

More than 40% of new patients started on Biktarvy. Aided by the growing momentum of Biktarvy, Descovy-based regimens accounted for 83% of our prescription volume for HIV treatment. Sequentially, the increase was primarily driven by the continued uptake of Biktarvy and PrEP and the full quarter impact of price increases taken in March of this year.

超過 40% 的新患者開始服用 Biktarvy。在 Biktarvy 日益增長的勢頭推動下，以 Descovy 為基礎的治療方案占我們 HIV 治療處方量的 83%。從季度來看，成長主要受 Biktarvy 和 PrEP 的持續普及以及今年 3 月價格上漲的整個季度影響所驅動。

In Europe, HIV product sales for the second quarter were $623 million and benefited approximately $70 million from the adjustment for statutory revenue clawback reserves related to sales made in prior years. Excluding the adjustment, our HIV product sales in Europe would have slightly declined sequentially.

在歐洲，第二季 HIV 產品銷售額為 6.23 億美元，其中約 7,000 萬美元受益於與往年銷售相關的法定收入追回準備金的調整。不計調整，我們在歐洲的 HIV 產品銷售額將較上季略有下降。

The year-over-year decline was predictable driven by the broad availability of generic versions of Truvada. We continue to see, however, the impact from generics moderating as the uptake of Descovy-based products progresses.

由於 Truvada 的仿製藥廣泛上市，同比下降是可以預見的。然而，隨著基於 Descovy 的產品的普及，我們繼續看到仿製藥的影響有所緩和。

Biktarvy is now available across the EU5 with launches occurring in Italy in June and in the U.K. in July. Already in France, Germany and Spain, Biktarvy is the #1 regimen for naïve and switch patients. With access increasing for Biktarvy, we're optimistic that the declines in our European HIV business will continue to moderate and that our Descovy-based franchise will continue to grow.

Biktarvy 現已在歐盟五國上市，將於 6 月在義大利上市，7 月在英國上市。在法國、德國和西班牙，Biktarvy 已成為初治患者和轉診患者的首選治療方案。隨著 Biktarvy 的普及，我們樂觀地認為，我們在歐洲的 HIV 業務下滑趨勢將繼續放緩，而我們基於 Descovy 的特許經營業務將繼續增長。

Turning to HCV, total HCV sales for the second quarter were $842 million. U.S. product sales for the second quarter were $355 million, down 35% year-over-year and down 10% sequentially. The year-over-year U.S. decline was in line with our expectation and primarily due to competitive dynamics and lower patient starts. Sequentially, the decrease was primarily due to the Q1 purchasing activity by a state Department of Corrections. As a reminder, we mentioned on our prior call that Q1 U.S. HCV sales were positively impacted by the timing of this state Department of Corrections order. We're very encouraged by the performance of the Asegua authorized generics, which accounted for more than 25% of our U.S. HCV revenues and continued to improve our HCV competitive positioning.

再來看C型肝炎，第二季丙型肝炎總銷售額為 8.42 億美元。美國第二季產品銷售額為 3.55 億美元，年減 35%，季減 10%。美國年減與我們的預期一致，主要原因是競爭動態和患者數量減少。從順序來看，下降的主要原因是第一季某州懲教部門的採購活動。提醒一下，我們在先前的電話會議中提到，由於該州懲教部門的這項命令的發佈時間，美國第一季丙型肝炎病毒（HCV）的銷售額受到了積極影響。我們對 Asegua 授權仿製藥的表現感到非常鼓舞，這些仿製藥占我們美國 HCV 收入的 25% 以上，並持續改善了我們在 HCV 領域的競爭地位。

In Europe, HCV product sales for the second quarter were $277 million and benefited approximately $80 million from the adjustment for statutory revenue clawback reserves related to sales made in prior years. Without the adjustment, HCV product sales would have declined 15% year-over-year and 1% sequentially.

在歐洲，第二季 HCV 產品銷售額為 2.77 億美元，其中約 8,000 萬美元受益於與往年銷售相關的法定收入追回準備金的調整。若不進行調整，HCV產品的銷售額將較去年同期下降15%，較上季下降1%。

Turning to cell therapy. Worldwide Yescarta sales for the second quarter were $120 million, up 76% year-over-year and 25% sequentially. We were pleased with the steady adoption of Yescarta. Our efforts in the U.S. remain focused on educating providers on the profile of Yescarta and identification of appropriate patients. Additionally, as the centers for Medicare and Medicaid services looks to finalize the annual Medicare IPPS rule for fiscal year 2020, we continue to engage with agency officials and other stakeholders with the goal of improving Medicare reimbursement and access for patients over 65 years of age. This remains an area of focus to ensure continued uptake of Yescarta.

轉向細胞療法。Yescarta 第二季全球銷售額為 1.2 億美元，年增 76%，季增 25%。我們對 Yescarta 的穩定普及感到滿意。我們在美國的工作重點仍然是教育醫療服務提供者了解 Yescarta 的特點和識別合適的患者。此外，隨著醫療保險和醫療補助服務中心著手最終確定 2020 財年的年度醫療保險 IPPS 規則，我們繼續與該機構官員和其他利益相關者進行溝通，目標是改善 65 歲以上患者的醫療保險報銷和就醫途徑。這仍然是我們關注的重點領域，以確保 Yescarta 的持續普及。

In Europe, Yescarta has launched in Germany, the U.K., France and Spain among the larger countries. Overall, we have been very impressed with the speed at which countries have provided reimbursement and the pace at which centers are being certified.

在歐洲，Yescarta 已在德國、英國、法國和西班牙等較大國家推出。總的來說，我們對各國提供報銷的速度和中心獲得認證的速度印象深刻。

Finally, I would like to comment on our cardiovascular products. As expected, we saw generic versions of Letairis introduced during the quarter. Letairis and Ranexa sales totaled $223 million for the second quarter, down 51% year-over-year and down 37% sequentially, as a result of competition from generics.

最後，我想談談我們的心血管產品。正如預期的那樣，我們在本季度看到了 Letairis 的通用版本推出。由於仿製藥的競爭，Letairis 和 Ranexa 第二季的銷售額總計為 2.23 億美元，年減 51%，季減 37%。

Letairis sales were sequentially higher in the second quarter, primarily due to a favorable inventory dynamics compared to a drawdown in Q1. But underlying prescription demand is eroding, and we anticipate going forward, sales will decline as we absorb the full quarter impact of generics.

Letairis 第二季的銷售額較上季成長，主要原因是庫存動態較第一季有所改善。但潛在的處方藥需求正在減弱，我們預計未來隨著仿製藥對本季業績的全面影響，銷售額將會下降。

Now turning to expenses. Non-GAAP R&D expenses were $916 million for the second quarter, down slightly compared to the same period last year primarily due to the 2018 impact of our purchase of a priority review voucher, largely offset by higher investments to support our cell therapy program.

現在來說說費用。第二季非GAAP研發費用為9.16億美元，與去年同期相比略有下降，這主要是由於2018年我們購買優先審查券的影響，但很大程度上被支持細胞療法計畫的更高投資所抵消。

Non-GAAP SG&A expenses were $1 billion for the second quarter, up 21% 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.

第二季非GAAP銷售、一般及行政費用為10億美元，比去年同期成長21%，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。

Our non-GAAP effective tax rate in the second quarter was 21.5% compared to 13.4% in the same period last year, which was impacted by a onetime favorable settlement of a tax examination.

第二季度，我們的非GAAP有效稅率為21.5%，而去年同期為13.4%，主要是由於一次性稅務審查和解帶來的有利結果。

Moving to the balance sheet. During the second quarter, we generated $2.2 billion in cash from operations and ended the quarter with $30.2 billion in cash and investments. We repaid $500 million of senior unsecured notes, paid cash dividends of $800 million and repurchased 9 million shares of stock for $588 million.

接下來查看資產負債表。第二季度，我們從經營活動中獲得了 22 億美元的現金，季度末現金和投資總額為 302 億美元。我們償還了 5 億美元的優先無擔保票據，支付了 8 億美元的現金股息，並以 5.88 億美元的價格回購了 900 萬股股票。

Moving to our guidance. We are raising our full year net product sales guidance based on favorable demand trends in the first half across our portfolio and the onetime adjustment for Europe statutory revenue clawback reserves. Net product sales are expected to be in the range of $21.6 billion to $22.1 billion.

按照我們的指導進行操作。鑑於上半年我們產品組合的良好需求趨勢以及歐洲法定收入追回準備金的一次性調整，我們提高了全年淨產品銷售預期。預計淨產品銷售額將在 216 億美元至 221 億美元之間。

We are also updating our full year diluted EPS impact of GAAP to non-GAAP adjustments, which are expected to be in the range of $3.90 to $4 a share as a result of the collaboration agreement with Galapagos. All other components of our guidance remain unchanged. With regard to full year SG&A guidance, we are leaving that unchanged as we prepare for future launches of filgotinib for rheumatoid arthritis.

我們還更新了 GAAP 調整為非 GAAP 調整後的全年稀釋每股收益影響，由於與 Galapagos 的合作協議，預計每股收益將在 3.90 美元至 4 美元之間。我們指南的其他所有組成部分均保持不變。關於全年銷售、一般及行政費用指引，我們保持不變，因為我們正在為未來推出用於治療類風濕性關節炎的filgotinib做準備。

Our guidance is subject to a number of uncertainties, which are outlined in Slides 23 to 24 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 23 至 24 頁中進行了概述。

So I want to thank everyone very much for joining today's call. Let's now open up the call for questions. Operator?

所以，我非常感謝大家參加今天的電話會議。現在開始接受提問。操作員？

(Operator Instructions) Our first question comes from Matthew Harrison with Morgan Stanley.

（操作員說明）我們的第一個問題來自摩根士丹利的馬修·哈里森。

Great. I wanted to ask one related to the HIV pipeline. I noticed that you've got a breakthrough designation on a capsid inhibitor, and I'm just wondering if you could talk a little bit more about the path to registration and how breakthrough enables you to potentially move that product ahead. And if you could just also comment on what you see as the patient opportunity for that product as well?

偉大的。我想問一個與愛滋病毒傳播途徑相關的問題。我注意到你們的衣殼抑制劑獲得了突破性療法認定，我想請你們詳細談談註冊途徑以及突破性療法如何幫助你們推進該產品的研發。您能否也談談您認為該產品在患者群中的潛在應用前景？

Great, Matthew. So we have Diana here, and she will be more than happy to address that.

太好了，馬修。戴安娜今天在這裡，她非常樂意回答這個問題。

Yes. This is Diana Brainard. We're very excited that the FDA recognized the importance of the capsid inhibitor GS-6207 by providing it with breakthrough designation for heavily treatment experienced patients with multidrug resistance. This is a small segment of the HIV population but represents a really high unmet medical need. These individuals have limited treatment options due to the resistance they have. And this highlights one of the important components of our capsid inhibitor, which is to say because it is first-in-class, there's no pre-existing resistance to this class, and it makes it really a unique compound in that regard, and that's part of the value it brings. Of course, the other piece is that it's long-acting. And so we see it as having value across a broad range of patient populations. In terms of the path to registration, what breakthrough designation does is allows us to communicate more frequently and have more dialogue with FDA. And in fact, we have plans to do that in the coming weeks where we'll get more clarity on exactly how we can best move our capsid inhibitor forward in this population as quickly as possible.

是的。這是戴安娜·布雷納德。我們非常高興 FDA 認可了衣殼抑制劑 GS-6207 的重要性，並授予其突破性療法認定，用於治療接受過多種藥物治療且具有抗藥性的患者。這雖然只佔愛滋病毒感染族群的一小部分，但卻代表著極高的未滿足醫療需求。由於這些患者存在抗藥性，他們的治療選擇有限。這凸顯了我們衣殼抑制劑的一個重要組成部分，也就是說，因為它是同類首創，所以目前還沒有針對此類藥物的抗藥性，這使其成為該領域真正獨特的化合物，這也是它帶來的價值之一。當然，另一個優點是它的藥效持久。因此，我們認為它對廣泛的患者群體都具有價值。就註冊途徑而言，突破性認定使我們能夠更頻繁地與FDA溝通並進行更多對話。事實上，我們計劃在接下來的幾週內這樣做，屆時我們將更清楚地了解如何盡快將我們的衣殼抑制劑更好地應用於該人群。

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。

Maybe another question on the capsid inhibitor. How important will it be to pair that with additional antiretroviral agents? Can you talk about where you are with respect to development of long-acting forms of internal assets that could potentially pair with 6207? And then along those lines, what's your sense at this point kind of mapping the Phase I PK data with the Phase II viral decline data as to how often, how frequently you think patients will need to be dosed in order to maintain adequate exposures and still have a small injection volume for that drug?

或許還可以問一個關於衣殼抑制劑的問題。將其與其他抗逆轉錄病毒藥物合併使用有多重要？您能否談談您在開發可能與 6207 搭配使用的長效內部資產方面所取得的進展？那麼，就目前而言，您如何看待將 I 期藥物動力學數據與 II 期病毒下降數據進行比對，以確定患者需要多久給藥一次才能維持足夠的藥物暴露量，同時保持較小的注射量？

Sure. Well, so I think when we talk about developing long-acting regimens, we're envisioning the capsid will need to be partnered with a second agent. And to that end, we've got a number of different internal candidates to become partners with capsid, and we hope to be rolling that data out and those plans out over the next coming months. In terms of the frequency of injection. One of the things about capsid that's so exciting is that it's got picomolar potency, which really makes it, in order of magnitude, more potent than any other approved antiretroviral, and allows us to give the amount of drug needed for very long-term injections. And so really, the frequency of drug injection is going to be dictated in large part by the partner and also by the formulation, and we're still gaining clarity on what the initial regimens will look like, but there's a huge potential here for very infrequent dosing.

當然。所以，我認為當我們談到開發長效療法時，我們設想衣殼需要與第二種藥物一起使用。為此，我們有一些不同的內部候選人可以成為 capsid 的合作夥伴，我們希望在接下來的幾個月中推出這些數據和這些計劃。就注射頻率而言。衣殼蛋白最令人興奮的一點是它具有皮摩爾級的效力，這使得它在數量級上比任何其他已批准的抗逆轉錄病毒藥物都更有效，並且使我們能夠給予長期注射所需的藥物量。因此，藥物注射的頻率很大程度上取決於伴侶以及藥物配方，我們仍在逐步明確初始治療方案的具體內容，但極少給藥的可能性非常大。

Our next question comes from Michael Yee with Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

Congrats on a good quarter. I wanted to talk a bit more high-level about R&D. Obviously, John McHutchison, not sure if you're in the room, but it's been good to spend the years together, particularly in the HCV days, but maybe just a comment either from John but obviously, Dan, going forward, where the shape of R&D goes from here? What you would like to try to do in the next, say, 12, 24 months? How oncology plays with that? And then the second part of the question is since you've done this Galapagos deal, it would seem that, that's a big part of early-stage discovery, how much of your R&D is early-stage discovery? And does that help offset some of that, again, sort of related to the first question.

恭喜你本季業績出色。我想更深入地談談研發方面的問題。約翰·麥克哈奇森，我不知道你是否在場，但很高興這些年來能和你一起共事，尤其是在丙型肝炎病毒（HCV）時期。約翰，當然還有丹，或許可以提個意見：展望未來，研發的方向是什麼？在接下來的12到24個月裡，您想嘗試做些什麼？腫瘤學是如何處理這個問題的？問題的第二部分是，既然你們已經完成了 Galapagos 的交易，這似乎是早期發現的重要組成部分，那麼你們的研發工作中有多少是早期發現呢？那這是否有助於抵銷其中的一些影響呢？這與第一個問題有點相關。

Yes. Michael, can I just get some clarity on your second question, sorry, around Galapagos. I want to make sure I understand what your question was there?

是的。邁克爾，關於你的第二個問題，不好意思，是關於加拉巴哥群島的，我能再確認一下嗎？我想確認一下我是否理解了你的問題是什麼？

Yes. I guess, if you can quantify or describe how much of your R&D budget, I think it's $3.5 billion, $4 billion, is early-stage discovery, it would seem that Galapagos is going to be either additive to that as resources? Or that, that could actually allocate some of your R&D early-stage to have them do some of that and supplement that?

是的。我想，如果你能量化或描述一下你的研發預算（我認為是 35 億美元到 40 億美元）中有多少用於早期發現，那麼 Galapagos 項目似乎要么會作為資源添加到這些預算中，要么會成為額外的資源？或者，是否可以將部分早期研發經費分配給他們，讓他們做一些這方面的工作，並作為補充？

Okay. So Michael, first of all, we will certainly pass your good wishes on to John McHutchison. He's got his team here but he's not in the room today, but John has really made tremendous contributions to Gilead, and we wish him nothing but the best as he seeks his next challenge.

好的。邁克爾，首先，我們一定會把你的美好祝福轉達給約翰·麥克哈奇森。他的團隊在這裡，但他今天不在現場。約翰為基列做出了巨大的貢獻，我們祝他在迎接下一個挑戰時一切順利。

But let me just comment first on your first question about the shape of R&D in the next 12 to 24 months. Well, again, I think a lot has happened in the past quarter, just to emphasize where we stood when we spoke just a few months ago. Certainly, we've had progress on the HIV front, which we just spoke about in the first 2 questions with Diana. But we've also gotten much greater clarity around the path forward for filgotinib. And with that path forward with filgotinib in rheumatoid arthritis, I remind you we have a very broad and expansive program around filgotinib in other diseases states, including IBD. And so we really have had a good quarter for our internal portfolio.

但首先，我想就你提出的第一個問題——未來 12 至 24 個月的研發格局——發表一下看法。嗯，我再次強調一下，過去一個季度發生了很多事情，這只是為了強調我們幾個月前談話時所處的立場。當然，我們在愛滋病防治方面取得了進展，我們剛才在與戴安娜的前兩個問題中也談到了這一點。但我們也對filgotinib的未來發展方向有了更清楚的認知。鑑於 filgotinib 在類風濕性關節炎治療方面的進展，我想提醒大家，我們圍繞 filgotinib 在其他疾病領域（包括 IBD）有一個非常廣泛和全面的計畫。因此，我們內部投資組合本季表現確實不錯。

Now moving forward. I mean, obviously, our emphasis is on growth, it's on long-term growth, it's on our ability to shape that R&D portfolio into an area where we have a good number of innovative medicines balanced across our stages of development. As we spoke about last time, one of the areas that we really need to continue to strengthen is our late-stage portfolio as well. And I do think that the collaboration with Galapagos and some of the acceleration of molecules that we have within Gilead will help us to strengthen that late-stage portfolio.

現在繼續前進。我的意思是，很顯然，我們的重點是成長，是長期成長，是將研發組合塑造成一個擁有大量創新藥物且在各個研發階段都保持平衡的領域。正如我們上次所討論的，我們需要繼續加強的領域之一就是我們的後期投資組合。而且我認為，與 Galapagos 的合作以及我們在吉利德內部加速研發的一些分子，將有助於我們加強後期產品組合。

I remind you with Galapagos, they have 2 products that are in later stage. One for IPF and one for osteoarthritis in addition to the broad program around filgotinib. But moving forward and more on this, Michael, later in the year. Obviously, inflammation with the lead with filgotinib, the work we have on HIV, long-acting treatments for highly experienced patients in care programs, oncology is a clear focus. And it certainly is within the cell therapy realm where we've had really some transformational effects on a subset of B-cell lymphomas. And our strategy there is to bring it to -- earlier lines of therapy with B-cell lymphoma to other hematologic malignancies to potentially solid tumors and to allogeneic. And then we're bridging that across to a broader oncology portfolio that we'll continue to advise you on within Gilead and partners that includes small molecules and bispecific antibodies that will be focused on really providing significant benefits for patients with high unmet medical needs in oncology.

我提醒您，Galapagos公司目前有兩款產品處於後期研發階段。除了針對菲爾戈替尼的廣泛項目外，還有一項針對特發性肺纖維化 (IPF) 的治療方案和一項針對骨關節炎的治療方案。但關於這方面的更多細節，邁克爾，我們將在今年晚些時候再談。顯然，發炎（以filgotinib為主導）、我們在HIV方面的工作、針對護理計劃中經驗豐富的患者的長效治療、腫瘤學都是我們明確的關注點。在細胞療法領域，我們已經對一部分 B 細胞淋巴瘤產生了真正的變革性影響。我們的策略是將其應用於—早期治療 B 細胞淋巴瘤、其他血液惡性腫瘤、潛在的實體腫瘤以及異基因治療。然後，我們將把這些成果整合到更廣泛的腫瘤產品組合中，我們將繼續在吉利德及其合作夥伴內部為您提供諮詢，其中包括小分子和雙特異性抗體，這些抗體將專注於真正為腫瘤領域存在高度未滿足醫療需求的患者帶來顯著益處。

And then finally, of course, liver diseases. We continue to work in the liver area on hepatitis B. We have important data readouts on NASH later this year. So I think when we sit here in the next couple of quarters, a lot of these things are also going to come to more fruition. We'll get a chance to look at what we have in our hands today in terms of late stage -- in terms of our portfolio. And we'll continue to supplement that with innovation from the outside, an innovation network like Galapagos.

最後，當然還有肝臟疾病。我們繼續在肝臟領域進行B型肝炎的研究。今年晚些時候，我們將公佈有關非酒精性脂肪性肝炎的重要數據。所以我認為，在接下來的幾個季度裡，當我們坐在這裡時，很多事情也將得到更好的實現。我們將有機會審視我們目前在後期階段——也就是我們的投資組合——所擁有的資產。我們將繼續從外部引入創新，例如像 Galapagos 這樣的創新網絡，來補充這些創新。

Secondarily, on Galapagos, in particular, I think it's probably the best way to put it into context, is -- and I said this on the call previously with Galapagos, it's with the collaboration with Galapagos, we essentially double our research capacity. And what does that mean? I mean, we've got roughly the same number of scientific colleagues across the 2 organizations. In fact, Galapagos will be increasing their number to get a little closer to what we have at Gilead, but it provides with 2 sources of early-stage discovery input into our late-stage portfolio. And I think that's very exciting because if we can get 2 highly productive research engines feeding the late-stage portfolio, that speaks well for kind of the future of our portfolio as we move forward. We haven't really completely disclosed exactly the spending patterns in each of those areas. I'll suffice it to say, that we'll -- those investments will be driven by the science, the decisions on the portfolio will be driven on making sure we keep the bar high for patients and we'll continue to look at other ways to expand that innovation network with early-stage collaborations and deals and when possible, late-stage collaborations and deals. Hopefully, Michael, that gives you a little color to, so far, what I can articulate in the past 5 months.

其次，就加拉巴哥群島而言，我認為最好這樣來解釋——我之前在與加拉巴哥群島的通話中也說過——正是透過與加拉巴哥群島的合作，我們基本上使我們的研究能力翻了一番。那是什麼意思呢？我的意思是，這兩個機構的科學研究人員數量大致相同。事實上，Galapagos 將增加其數量，以更接近 Gilead 的規模，但它為我們的後期投資組合提供了 2 個早期發現的來源。我認為這非常令人興奮，因為如果我們能擁有 2 個高效的研究引擎來支撐後期投資組合，這預示著我們投資組合的未來發展前景良好。我們還沒有完全公開這些領域的具體支出模式。我只想說，這些投資將以科學為導向，投資組合的決策將以確保我們為患者保持高標準為目標，我們將繼續尋找其他方式，透過早期合作和交易，以及在可能的情況下，透過後期合作和交易來擴展創新網絡。邁克爾，希望這能讓你對我在過去 5 個月所表達的內容有所了解。

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

我們的下一個問題來自 Geoff Porges 和 Leerink 的提問。

Dan, there's been a lot of pretty interesting moves in the industry at sort of a macro level, companies changing portfolios, shifting assets around. And I realize your focus has primarily been on R&D, but is there anything that you believe you could potentially consider moving out of the company's portfolio? Or do you have any appetite for bringing in any marketed products that might be available for any other company's portfolios? And just related to that, could you comment on how much of an issue FTC considerations are as you look at outside products given what we've seen so far this year?

丹，從宏觀層面來看，業界出現了許多非常有趣的變動，例如公司調整投資組合、轉移資產等等。我知道您一直專注於研發，但您認為是否有任何項目可以考慮從公司的產品組合中移除？或者，您是否有興趣引進其他公司產品組合中可能已有的市場產品？另外，關於這一點，鑑於我們今年迄今為止所看到的情況，您能否評論一下，在考慮外部產品時，聯邦貿易委員會的考慮有多重要？

Geoff, yes, I mean, I guess, just taking a step back about how we look at our approach to M&A overall and our partnerships. Again, I would say that you're right, there's a lot of moves in the field. I think what's characterized Gilead is the ability to really focus on the science in a way that's been pretty transformational with HCV and HIV. And I've commented before on my observation on the quality of the science and the scientists that are here at Gilead, and I would only emphasize again after 5 months. And that's important not only for the science we do within the company, it's also important for how we can evaluate external scientific opportunities. I can say that as we partner with Galapagos, the respect and admiration from a scientific perspective between Gilead and Galapagos was very high, and that's what led me with confidence to move forward with the team in striking that deal. So we will be driven by science, for sure. We'll focus on the areas of expertise that we have today. I mean, that's HIV, oncology, liver disease, inflammation and the intersections between those 2.

傑夫，是的，我的意思是，我想，我們只是想退後一步，重新審視我們對併購的整體方法以及我們的合作關係。我再次表示贊同，你說得對，這個領域有很多變動。我認為吉利德的特點是能夠真正專注於科學，這在C型肝炎和愛滋病方面具有相當大的變革性意義。我之前曾評論過我對吉利德公司科學水平和科學家的看法，5 個月後，我只想再次強調這一點。這不僅對我們公司內部的科學研究很重要，對我們如何評估外部科學機會也很重要。我可以肯定地說，在與 Galapagos 合作的過程中，吉利德和 Galapagos 在科學方面彼此尊重和欽佩，這讓我有信心與團隊一起達成這項協議。所以，我們一定會以科學為導向。我們將專注於我們目前所擅長的領域。我的意思是，這包括愛滋病、腫瘤、肝病、發炎以及這兩者之間的交叉領域。

To your point, I mean, I don't think we'll have a one-size-fits-all strategy for bringing innovation into the company. I think that the Galapagos structure was the right structure for that collaboration. It allowed independence, it allowed us to secure our investment, it allowed us rights to everything that comes out of that investment and therefore, that collaboration was fit for purpose for that particular transaction. But it doesn't mean that we won't look at different ways of transacting when we look at other opportunities out there. Some will be more straightforward, particularly if they come right into our value chain and our distribution chain as more of a late-stage aspect.

你說得對，我的意思是，我認為我們不會有一個適用於所有情況的創新策略來推動公司發展。我認為 Galapagos 的組織架構是這種合作的正確架構。它賦予了我們獨立性，並保障了我們的投資，賦予了我們獲得該投資所產生一切收益的權利，因此，這種合作方式非常適合該項特定交易的目的。但這並不意味著我們在尋找其他機會時，不會考慮不同的交易方式。有些事情會比較直接，特別是如果它們作為後期環節直接進入我們的價值鍊和分銷鏈的話。

On the FTC standpoint, I don't really have a lot of comments there. I think we haven't had any issues right now with FTC and the type of transactions we're going after, so I don't have a whole lot of personal insight into that question as well. So hopefully, that gives you some indication of how we'll continue.

從聯邦貿易委員會的角度來看，我沒有什麼特別要說的。我認為目前我們還沒有遇到聯邦貿易委員會和我們正在調查的那類交易的任何問題，所以我對這個問題也沒有太多個人見解。希望這能讓您對我們接下來的安排有所了解。

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。

Congrats on the very solid quarter. I just want to talk about trends in Europe. I'm slightly intrigued by the fact that you guys tend to like -- are able to mitigate kind of the generic pressure you're seeing from the Biktarvy offsets, and I just want to get a little bit more color on why you think that's the case. I mean we all know Europe is fairly cost-conscious. And I understand that there's a differentiated profile. But what had really been the driver there that allows you to have growth in your TAF franchise there?

恭喜你們本季業績非常出色。我只想談談歐洲的趨勢。你們似乎喜歡——並且能夠減輕 Biktarvy 偏移帶來的那種普遍壓力——這一點讓我有點好奇，我想更詳細地了解一下你們為什麼這麼認為。我的意思是，我們都知道歐洲人對成本相當敏感。我了解到這其中存在差異化的情況。但究竟是什麼因素真正推動了您在當地的TAF特許經營業務的成長呢？

So Alethia, I'll take that one. I mean I think it really has been the underlying opportunity that we have with Descovy. We have seen with the Descovy now, launch of -- Biktarvy -- sorry. Biktarvy, we've just seen really a moderating of that deceleration. So it really speaks to the innovation of the product and the drug and we've seen really solid adoption.

所以，阿萊西亞，我選這個。我的意思是，我認為這確實是我們與 Descovy 合作所面臨的潛在機會。我們已經看到 Descovy 的推出——抱歉，是 Biktarvy。Biktarvy，我們已經看到這種減速趨勢有所緩和。這充分體現了該產品和藥物的創新性，而且我們已經看到了非常穩定的市場接受度。

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

我們的下一個問題來自瑞銀集團的卡特古爾德。

Maybe one for, I guess, Dan or Johanna, can you maybe just to elaborate a bit further on how should we think about PrEP providing another leg of growth for the HIV franchise, particularly given some of your moves in the quarter to improve access in the U.S. and I guess, when you think about Europe, some of the historical challenges there? And then I guess a follow-up there, just any insight you could provide on what you expect the focus of the AdCom to be for Descovy there?

我想，丹或喬安娜，你們能否進一步闡述一下，我們應該如何看待 PrEP 為 HIV 產品線帶來新的增長動力，特別是考慮到你們在本季度為改善美國市場的可及性而採取的一些措施，以及考慮到歐洲面臨的一些歷史挑戰？然後我想再追問一下，您能否就您認為AdCom對Descovy的關注重點是什麼提供一些見解？

Great. So we'll have Johanna pick up on the first aspect of your question, Carter. And then Diana can talk about the AdCom.

偉大的。那麼，卡特，我們將請喬安娜來回答你問題的第一個面向。然後戴安娜就可以談談招生委員會的事了。

Yes. So thanks for the question, Carter. So basically, in PrEP, what you'll see today, if you think about our Truvada business, the growth is very solid, it's about a 27% growth year-on-year. But having said that, there's only about 200,000 individuals that are actually on Truvada, and that represents about 20% to 25% of the total potential of individuals that could benefit from prevention treatment, and that's where Descovy comes in. And I do think Descovy, as we talked about earlier on this call, real opportunity in light of the fact that it just has such benefit in the prevention setting for a broad patient population -- a broad population of individuals namely because of its superior safety both on bone and renal as well as the fact that there's a rapid onset and longer sustained duration of HIV protection than Truvada. So those things will definitely play an important role as we think about our launch for Descovy moving forward in the second half of this year.

是的。謝謝你的提問，卡特。所以基本上，在 PrEP 領域，如果你看看我們 Truvada 的業務，你會發現它的成長非常穩健，年成長約 27%。但即便如此，目前實際服用 Truvada 的人數只有大約 20 萬，這僅佔可能從預防性治療中受益的總人數的 20% 到 25%，而這正是 Descovy 的用武之地。而且我認為，正如我們之前在電話會議中討論的那樣，Descovy 確實具有真正的機遇，因為它在預防方面對廣泛的患者群體有如此大的好處——之所以說是廣泛的患者群體，主要是因為它在骨骼和腎臟方面具有更高的安全性，而且與 Truvada 相比，它能快速起效並更持久地提供 HIV 保護。因此，在我們考慮今年下半年 Descovy 的發布計劃時，這些因素肯定會發揮重要作用。

On the flip side, you talked about a little bit about Europe. Obviously, Truvada PrEP in Europe is not available in light of the fact that it was genericized, but we will be looking at filing for PrEP in the first half of next year. And maybe, Diana, for the...

另一方面，你也稍微談​​到了歐洲。顯然，由於 Truvada PrEP 已被仿製藥化，因此它在歐洲無法獲得，但我們將在明年上半年考慮申請 PrEP 的上市許可。或許，戴安娜，是為了…

Sure. Yes. So with respect to the AdCom, the FDA has the liberty to convene an advisory committee for a number of different reasons. And in this case, for Descovy for PrEP, I think it's probably part of a larger effort to increase awareness and signal the commitment of the government to HIV PrEP efforts. And this is a forum where experts can come together and provide a discourse on the benefits of PrEP and also the trial results of DISCOVER. And as you know, we are seeking a broad indication for Descovy for PrEP, and our study was conducted in men and transgender women who have sex with men. And so this will certainly be a topic for discussion as well as the study results themselves, and so that's what we're prepared for.

當然。是的。因此，就諮詢委員會而言，FDA 可以出於多種不同的原因召集諮詢委員會。就 Descovy 的 PrEP 產品而言，我認為這可能是政府為提高公眾意識、表明其對 HIV PrEP 工作的承諾而做出的更大努力的一部分。這是一個專家們可以齊聚一堂，探討 PrEP 的益處以及 DISCOVER 試驗結果的論壇。如你所知，我們正在尋求 Descovy 在 PrEP 方面的廣泛適應症，我們的研究是在與男性發生性關係的男性和跨性別女性中進行的。因此，這肯定會成為討論的議題，研究結果本身也會成為討論的議題，而我們也正為此做好準備。

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 2 pipeline programs, if I may. First, on filgotinib, so based on everything disclosed so far in the pool data, there is no DVT imbalance, and that's very important. But my question was, what about all thrombotic events? For example, the retinal vein occlusion in FINCH 2 was technically not a DVT. So what about all thrombotic? Is that still no imbalance at all? That's point #1.

如果可以的話，我想重點介紹兩個人才培育計畫。首先，關於 filgotinib，根據目前為止在匯總數據中披露的所有信息，沒有 DVT 失衡，這一點非常重要。但我的問題是，所有血栓事件又該如何處理呢？例如，FINCH 2 中的視網膜靜脈阻塞嚴格來說並不是深部靜脈栓塞。那麼所有血栓性疾病呢？那難道還完全沒有失衡嗎？這是第一點。

And the second one was on the Galapagos IPF program, we know the Phase II trial they ran had a meaningful baseline imbalance on FVC medians. And my question is have you analyzed the FVC data on similar sets of FVCs on the placebo arm versus the active arm?

第二個項目是關於 Galapagos IPF 項目的，我們知道他們進行的 II 期試驗在 FVC 中位數方面存在顯著的基線不平衡。我的問題是，您是否分析過安慰劑組和活性治療組中類似 FVC 數據集的 FVC 數據？

So we're going to get John involved here. John Sundy, so.

所以我們要讓約翰參與進來。約翰‧桑迪，就是這樣。

Sure. So first of all, to start off with filgotinib. Getting to the issue of -- issues across all thrombotic events, we are still very pleased with the results across all those events and don't really see anything that would change our perspective on that compared to the specific data that we've presented already.

當然。首先，我們先從filgotinib開始。談到所有血栓事件的問題，我們對所有這些事件的結果仍然非常滿意，並且與我們已經提出的具體數據相比，我們並沒有看到任何會改變我們對此的看法的事情。

Moving on to the Galapagos compound, as you might imagine, we looked very carefully at all of the available data in the IPF program. We have quite a bit of experience in IPF ourselves with prior programs at Gilead as well. And we saw that -- data that really provided the confidence to Galapagos to be able to move ahead and we share that confidence with them.

接下來是加拉巴哥化合物，正如你可能想像的那樣，我們非常仔細地查看了 IPF 計劃中所有可用的數據。我們本身在特發性肺纖維化（IPF）方面也累積了相當多的經驗，之前在吉利德也參與過相關計畫。我們看到了這一點——數據確實讓加拉巴哥群島有信心繼續前進，我們也與他們分享了這種信心。

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

我們的下一個問題來自花旗銀行的 Mohit Bansal。

So quick question on capsid inhibitor. Do you think a long-acting agent such as capsid inhibitors could expand the PrEP market? Just to penetrate it 20%. And then when can we learn more about your plan for capsid in PrEP?

關於衣殼抑制劑，我有個問題想請教一下。您認為像衣殼抑制劑這樣的長效藥物能否擴大 PrEP 市場？僅僅滲透20%。那麼我們什麼時候可以了解更多關於您在PrEP中使用衣殼蛋白的計劃呢？

Yes, before I turn it over to Diana, we'll get -- I think it's a good question. By the way, we fully intend, prior to the capsid, to get beyond 20% of the PrEP market with both Truvada and Descovy. I mean and you're seeing the increase, of course, quarter-on-quarter there. But also, our wraparound programs with the community and really taking this more global. So there's lots of opportunity with the current programs. Having said that, Diana, if you want to address maybe the capsid for PrEP concept?

是的，在我把它交給戴安娜之前，我們會先——我認為這是一個很好的問題。順便說一句，我們完全打算在推出衣殼之前，憑藉 Truvada 和 Descovy 兩款產品，將 PrEP 市佔率提升至 20% 以上。我的意思是，當然，你也看到了季度環比的成長。此外，我們還有與社區合作的配套項目，並真正將這些項目推向全球。所以，目前的課程設置提供了許多機會。話雖如此，戴安娜，如果你想談談 PrEP 的衣殼概念嗎？

Sure thing. And I didn't catch the second part of the question, but I'll answer the first part. So Johanna mentioned this large gap between the number of people in the U.S. who are eligible for PrEP and the number of people who are on PrEP. And of course, we're trying to close that gap. But the part of that strategy is going to be having additional options beyond daily PrEP, and the capsid inhibitor could be 1 approach to that. It's got a long-acting potential. We're looking at preclinical models to assess its efficacy in the PrEP setting, and we're very excited about its potential as are physicians and the community about having this as an option. So we're looking forward to generating the data that will allow us to get into the clinic with that.

當然可以。我沒聽清楚問題的第二部分，但我會回答第一部分。喬安娜提到了美國符合 PrEP 條件的人數和正在服用 PrEP 的人數之間的巨大差距。當然，我們正在努力縮小這一差距。但該策略的一部分是除了每天服用 PrEP 之外，還要有其他選擇，而衣殼抑制劑可能是實現這一目標的一種方法。它具有長效作用的潛力。我們正在研究臨床前模型，以評估其在 PrEP 環境中的療效，我們對它的潛力感到非常興奮，醫生和社區也對擁有這種選擇感到非常興奮。因此，我們期待產生相關數據，以便將其應用於臨床。

Our next question comes from the line of Cory Kasimov with JPMorgan.

我們的下一個問題來自摩根大通的 Cory Kasimov。

So I guess Dan, I'm curious, how should investors be thinking about building out your management team versus building out the company's capabilities via external BD? In other words, there are clearly some important positions to fill such as a permanent CFO or permanent CSO, et cetera. So how much are the search for assets and technologies and the search for personnel correlated or mutually exclusive? Obviously, I recognize what you recently were able to do with Galapagos, but there was an established relationship that was already there.

所以我想問的是，丹，我很好奇，投資人該如何看待組建你的管理團隊和透過外部業務拓展來提升公司能力之間的關係？換句話說，顯然有一些重要職位需要填補，例如常任財務長或常任首席策略長等等。那麼，對資產和技術的搜尋與對人才的搜尋在多大程度上是相關的，還是互相排斥的？我當然知道你們最近在加拉巴哥群島的成就，但你們之間早已建立了連結。

Cory, I really appreciate the opportunity to answer that. I think they can both very much happen in parallel. I mean, I can just articulate that the Galapagos collaboration, for instance. I mean it involved teams of people within our organization that are absolutely dedicated to both the discovery platform aspect of it as well as the clinical programs. And so I don't see any slowdown at all in our ability to proceed ahead with corporate development during this period when we're still recruiting key individuals. First of all, Robin is here and very active, so we don't lack a CFO by any means, and we'll certainly have a good transition of a CFO before Robin leaves. And Robin's appetite to continue to grow the portfolio is good. Isn't it, Robin?

科里，我非常感謝有機會回答這個問題。我認為這兩件事完全可以同時發生。我的意思是，例如，我可以清楚地闡述加拉巴哥群島的合作。我的意思是，這涉及到我們組織內部的團隊，他們完全致力於發現平台方面以及臨床專案。因此，我認為在我們仍在招募關鍵人才的這段時期內，我們推動企業發展的能力完全不會受到任何影響。首先，Robin 已經到崗，而且非常積極，所以我們絕對不缺財務官，而且在 Robin 離開之前，我們肯定會順利完成財務長的交接。羅賓對繼續擴大投資組合的意願很好。是不是，羅賓？

Very high.

非常高。

Okay. We don't suffer from anything there. We have a very, very effective Corporate Development team in the organization that Andy built up over the past couple of years, but the most important thing about the effectiveness of that corporate development team is that they're interconnected with all the different respective experts within the organization. So Diana's team and John's team and the other [central TA] heads and then Bill Lee's team and the entire research organization. So that machine is still operating at full steam and full effectiveness, so I just want you to know that. In the interim, of course, we are then proceeding ahead with Robin's replacement and with John's replacement. And we look forward to bringing some additional new colleagues into the organization that will also be focused on science and growth and driving the future of Gilead's mission like we did with Johanna and with Christi so far.

好的。我們在那裡什麼事都沒遇到。我們公司擁有一支非常非常有效率的企業發展團隊，這是安迪在過去幾年建立起來的。但這個企業發展團隊高效的關鍵在於，他們與公司內部所有不同的相關專家都建立了聯繫。所以，戴安娜的團隊、約翰的團隊、其他[中央助教]負責人、比爾李的團隊以及整個研究機構。所以那台機器仍然全速有效率地運轉，我只是想讓你知道這一點。當然，在此期間，我們正在推進羅賓的繼任者和約翰的繼任者人選的遴選工作。我們期待為組織引入更多新的同事，他們也將專注於科學和發展，並像我們迄今為止對 Johanna 和 Christi 所做的那樣，推動吉利德未來使命的實現。

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。

My question is specifically on the recent proposed changes to Medicare and specifically, Part D, I'm wondering if you would be willing to disclose what proportion of your U.S. revenue in Q2 came from Part D? And whether Gilead's done any preliminary analyses of those changes and their potential impact on your revenue? It seems like based on the pricing of your medicines, you were right around the break point between helping and hurting revenues. So I'm curious if you've done any fine analyses to figure what the impact would be?

我的問題具體是關於最近提出的醫療保險改革方案，特別是D部分，我想知道您是否願意透露您第二季度美國收入中來自D部分的比例是多少？吉利德是否對這些變化及其對貴公司收入的潛在影響進行任何初步分析？根據你們藥品的定價來看，你們似乎正處於提高收入和損害收入的臨界點附近。所以我很想知道你是否做過任何細緻的分析來弄清楚會產生什麼影響？

Will you start?

你準備開始嗎？

Yes. Let me start, Phil. Let me give you a little context and then I'll turn it over to Robin on some details. So first of all, I mean I think it's important to note that there's a lot of things that have been happening in Washington recently and a lot of things that are -- still need to be provided clarity with. What I would say is a couple of things over this past quarter have been very encouraging. First of all, the work that we've done with the administration on ending the HIV epidemic, our drug donation and the ability to get to many, many more patients with HIV, really shows the support we have around increasing those number of individuals that are eligible for PrEP. The other thing is the Part D protected class rule was a really important patient choice legislation that was upheld, and that's -- we think that's good for patients, we also think that supports our portfolio as well. And then the other thing that I think is a really ongoing dialogue is the consensus that we have now, that's emerging around the need for new solutions and different approaches for CAR T therapies. So I just point to those 3 things as things that I think have been really encouraging for our portfolio that happened in the past quarter. Now at the same time, we completely accept and understand that there's going to continue to be pressure on drug pricing. I remind you that the vast majority of our business is driven by volume. We're actively involved, of course, in the Part D discussions and where that may go. We believe in initiatives that support caps to patient out-of-pocket expenses, that help patients at the end of the day and Part D reform, and that's where we and others in the industry are rolling our sleeves up on to be active participants in Part D reform.

是的。我先開始吧，菲爾。我先簡單介紹一下背景，然後把一些細節交給羅賓來解答。首先，我認為需要指出的是，最近華盛頓發生了很多事情，還有很多事情——仍然需要澄清。我想說的是，過去一個季度有兩件事非常令人鼓舞。首先，我們與政府合作，致力於終結愛滋病流行，我們捐贈的藥物以及能夠接觸到更多愛滋病患者的能力，真正表明了我們在增加符合 PrEP 條件的人數方面所獲得的支持。另外，D 部分受保護類別規則是一項非常重要的患者選擇立法，它得到了維護，我們認為這對患者有好處，我們也認為這對我們的投資組合也有好處。我認為另一個持續進行的對話是，我們現在逐漸達成共識，需要新的解決方案和不同的 CAR T 療法方法。所以，我只想指出這三件事，我認為它們是上個季度對我們的投資組合來說非常令人鼓舞的事情。同時，我們也完全接受並瞭解，藥品定價將繼續面臨壓力。我提醒各位，我們絕大多數的業務都是由銷售驅動的。我們當然積極參與了D部分的討論以及其可能的發展方向。我們相信那些旨在限制患者自付費用上限、最終幫助患者的舉措以及D部分改革，而這正是我們和業內其他人士正在擼起袖子積極參與D部分改革的地方。

Specifically, relative to our exposure to Part D, I don't know, I'm going to turn it over to Robin and see if she has any other things she wants to add there.

具體來說，關於我們接觸到的 D 部分，我不知道，我要把它交給 Robin，看看她是否還有其他想補充的內容。

No, Dan. I think you've covered a lot of areas. I will only add -- so that we don't typically disclose the various specific payer mix. I will tell you that overall it's a low double-digit percentage. If you think about Gilead, particularly our HIV, I mean, overall, we have a high proportion of public pay, right, and we've always come up with innovative programs as Dan was describing, some that support full access for those patients. So I think that is something that we'll continue to do as we work with Washington.

不，丹。我認為你已經涵蓋了很多方面。我只想補充一點——這樣我們通常就不會透露各種特定的付款方組合。我可以告訴你，整體而言，這個比例只有兩位數的低百分比。如果你想想吉利德，特別是我們的 HIV 治療，我的意思是，總體而言，我們有很高比例的公共資金投入，對吧，而且正如丹所描述的那樣，我們一直都在推出創新項目，其中一些項目支持這些患者獲得全面的治療。所以我認為，這是我們在與華盛頓合作的過程中將繼續做的事情。

Our next question comes from the line of Salim Syed with Mizuho.

我們的下一個問題來自 Salim Syed 與瑞穗銀行的合作。

Dan, I just wanted to talk about hepatitis B, as in boy, for a second. So the beginning of the year, before you joined, I believe some of your colleagues mentioned that Gilead plans to be a leader in hepatitis B. I was wondering if you still maintain that view. How you prioritize it within the company versus perhaps oncology or inflammation areas? And if there's any science that you feel like you don't have that is of interest to you.

丹，我只想跟你簡單談談B肝，我是說男孩的B肝。今年年初，在你加入公司之前，我相信你的一些同事曾提到吉利德計畫成為B型肝炎領域的領導者。我想知道你是否仍然堅持這種觀點。公司內部如何權衡其優先級，例如與腫瘤學或發炎領域相比？如果你對某個科學領域有興趣，但又覺得自己缺乏這方面的知識，那就太好了。

I'm still digging into that a bit, Salim, but it's clear that we have tremendous expertise in our organization and colleagues that are focused on liver disease and in particular hepatitis B. It's also clear that our current product, Vemlidy, is a significant benefit for patients with hepatitis B and underutilized. So one of the things we're working with Johanna and others on in the organization is how do we make the current standard of care more available to patients at need and at risk around the world. And that's something you may hear more from us on in the coming quarters.

薩利姆，我還在進一步研究這個問題，但很明顯，我們機構和同事在肝病，特別是乙型肝炎方面擁有豐富的專業知識。同樣明顯的是，我們目前的產品Vemlidy對B型肝炎患者來說意義重大，但卻沒有充分利用。因此，我們正在與 Johanna 和組織中的其他人一起研究的一件事是，如何讓世界各地有需要和有風險的患者更容易獲得當前的護理標準。接下來幾個季度，您可能會聽到我們更多地談及此事。

But relative to your question about the next level of advances in hepatitis B, and I also had the experience to talk to some key thought leaders around this as well. There's no doubt that it's a challenging scientific area to think about coming up with a hep B cure. And yet, I still think there's some very promising scientific avenues. As you can imagine, I won't comment necessarily on specific technologies that we either have in-house or that we think we may need to partner and to collaborate with. But I would give you confidence that we know the landscape extraordinarily well, we know the science extraordinarily well.

但關於你提出的乙肝治療下一階段進展的問題，我也有幸與一些這方面的關鍵思想領袖進行了交流。毫無疑問，尋找B肝治療方法是一個極具挑戰性的科學領域。然而，我仍然認為有一些非常有前景的科學研究方向。正如你所想，我不會對我們公司內部擁有的具體技術，或者我們認為可能需要與之合作的技術發表評論。但我可以向你保證，我們對這片土地的地形地貌非常了解，我們對相關的科學知識也非常精通。

And like many viral diseases, we may need to think about combination approaches in this area to get to longer duration and sustained responses. But because of the sensitivity of some of those programs, I'm not going to get into more detail. But suffice it to say that I think, as a company with our type of expertise, that we do need to be on the cutting edge of hep B, and we need to be thoughtful about how we approach it and what level of investment we put into it. But there's no doubt that as long as our scientists think there's an avenue forward, we should be -- we should have some concentration in that area.

就像許多病毒性疾病一樣，我們可能需要考慮採用組合療法，以獲得更持久有效的治療效果。但由於其中一些節目的敏感性，我不會透露更多細節。但總而言之，我認為，作為一家擁有我們這種專業知識的公司，我們確實需要在乙肝領域保持領先地位，我們需要認真思考我們如何處理這個問題以及我們投入多少資金。但毫無疑問，只要我們的科學家認為有前進的方向，我們就應該——我們應該在這個領域投入一些精力。

Our next question comes from the line of Hartaj Singh with Oppenheimer.

我們的下一個問題來自哈塔吉·辛格和奧本海默的對話。

I just had a question on Yescarta. You reported now a good quarter, I think, 2 in a row. I think you had indicated earlier in the year, this year, that you had over 1,500 patients on the therapy, which had accelerated from the end of 2018. Could you just give some more color on the dynamics of the patient adds in Yescarta and how you're feeling for the rest of the year? Plus also how, over the next couple of years, you will sort of roll out into earlier lines of therapy if that clinical data reads out?

我剛剛在Yescarta上有一個問題。我認為，你們連續第二季都取得了不錯的業績。我認為您在今年稍早曾表示，您有超過 1500 名患者正在接受這種療法，這一數字從 2018 年底開始加速成長。能否再詳細介紹 Yescarta 患者新增病例的動態變化，以及您對今年剩餘時間的展望？此外，如果臨床數據顯示療效良好，那麼在接下來的幾年裡，你們將如何逐步推廣到更早期的治療方案中？

Hartaj, so let me start and then maybe other colleagues want to add a little bit here. So let me just restate my belief that I said on previous quarters that as Gilead thinks strategically about how to approach an entry into oncology, I think the concept of approaching it with a pioneering technology is a very sensible path forward. In other words, instead of jumping into where everybody else is right now, really moving to where the treatment paradigm could go I think makes sense. Now with the pioneering technology comes all of the rewards and risks associated with being on the cutting edge of science. But I would say that I'm very impressed by the data that's been generated so far from the Kite team and the sustained level of responses we're getting, and we'll continue to update you on those responses. I know again later this year as well on the duration of those responses, but we're seeing a very consistent response in that subset of DLBCL patients.

哈塔吉，那就讓我先開始吧，然後其他同事也許想補充一點。所以，我想重申我之前幾季說過的觀點，即吉利德在策略上考慮如何進入腫瘤領域時，我認為採用開創性技術是一個非常明智的前進方向。換句話說，與其盲目地加入大家現在所處的階段，不如真正朝著治療模式可能的發展方向前進，我認為這才是明智之舉。如今，伴隨這項開創性技術而來的是所有與站在科學前沿相關的回報和風險。但我必須說，我對 Kite 團隊目前為止產生的數據以及我們收到的持續回饋印象深刻，我們將繼續向您通報這些回饋。今年稍後我還會再次了解這些反應的持續時間，但我們看到，在 DLBCL 患者的這一部分中，反應非常穩定。

So but in addition to the scientific strength of this and the broader R&D program that I mentioned before about moving into earlier lines of therapy, other hematologic diseases, solid tumors and allogeneic, I would say that there are clearly some near-term factors that can affect the trajectory of Yescarta. We're carefully monitoring those, something I've been personally involved in is some of the discussions around the reimbursement changes. Robin mentioned in her prepared remarks around the Medicare reimbursements and then we're also investigating further patient flow dynamics. So I think there's no doubt that in the near term with the pioneering technology where hospitals are getting used to how to get reimbursed, CMS is trying to come up with new programs, as you've seen published, about how to encourage adoption for Medicare patients. There could be some variability, if you like, on the quarter-to-quarter sales for Yescarta.

所以，除了這項技術本身的科學實力以及我之前提到的更廣泛的研發計劃（包括早期治療、其他血液疾病、實體瘤和同種異體治療）之外，我認為顯然有一些近期因素會影響 Yescarta 的發展軌跡。我們正在密切關注這些情況，我個人也參與了一些關於報銷變更的討論。Robin 在她準備好的發言稿中提到了醫療保險報銷問題，我們也正在進一步調查病患流動動態。因此，我認為毫無疑問，在短期內，隨著醫院逐漸習慣於如何獲得報銷，CMS（醫療保險和醫療補助服務中心）正在努力推出新的項目，正如你所看到的已發表的，旨在鼓勵Medicare患者採用這些項目。Yescarta 的季度銷售額可能會有一些波動。

But having said that, when I just take a step back and think about the mid- to long-term trajectory of Yescarta and the duration of response in patients, I continue to be very encouraged and as the quarters go on, we'll be able to, of course, provide data for you on the continued profile of Yescarta just as we did at ASCO, of course, where we talked about some of the ways to ameliorate some of the initial responses and to -- encourage Yescarta in even more patients from an early standpoint. So that's what I would say so far about Yescarta. I don't know, Robin, would you like to add anything on that?

但話雖如此，當我退後一步，思考 Yescarta 的中長期發展軌跡以及患者療效的持續時間時，我仍然感到非常鼓舞。隨著季度的推進，我們當然能夠像在 ASCO 會議上一樣，繼續為您提供 Yescarta 的療效數據。在 ASCO 會議上，我們討論了一些改善初始療效的方法，並鼓勵更多患者儘早使用 Yescarta。以上就是我對 Yescarta 目前為止的看法。羅賓，我不知道，你還有什麼要補充的嗎？

No. I think you covered all the areas, Dan. And as I've said on the call, we also have Europe now. We're very encouraged relative to the receptivity, reimbursement. It's an innovative therapy but we're doing very well with our launch there in addition to all the factors that you mentioned in the U.S.

不。丹，我覺得你已經涵蓋了所有方面。正如我在電話會議上所說，我們現在還有歐洲。我們對各方的接受度和報銷情況感到非常鼓舞。這是一種創新療法，除了您在美國提到的所有因素之外，我們在那裡的推出也非常成功。

And just maybe one last point on that. So we expect the new Medicare reimbursement rule to go into effect in October of this year. So that's, obviously, going to be a key pivot point for how we see uptake and use in Medicare patients. And we know that the use of Yescarta in Medicare patients also has an influence in centers on how they treat their non-Medicare patients. So lots to continue to innovate here not just on the science but also on the reimbursement and access programs, we're fully committed to that.

關於這一點，或許還有最後一點要補充。因此，我們預計新的醫療保險報銷規則將於今年10月生效。所以，很顯然，這將是我們如何看待 Medicare 患者的接受度和使用情況的關鍵轉折點。我們知道，在 Medicare 患者中使用 Yescarta 也會影響醫療中心對待非 Medicare 患者的方式。因此，我們有很多東西需要繼續創新，不僅在科學方面，而且在報銷和准入計劃方面，我們對此全力以赴。

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

今天的問答環節到此結束。我謹將電話轉回給李成先生，請他作總結發言。

Thank you, Liz. And thank you, everyone, for joining us. The team here looks forward to providing you an update on our next call.

謝謝你，莉茲。感謝各位的參與。我們團隊期待在下次通話中向您報告最新進展。

Ladies and gentlemen, thank you for your participation in today's conference.

女士們、先生們，感謝各位參加今天的會議。

This concludes the program, and you may now disconnect. Everyone, have a great day.

程式到此結束，您可以斷開連線了。祝大家今天過得愉快。