吉利德科學 (GILD) 2018 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Third Quarter 2018 Earnings Conference Call. My name is Sherry, 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2018年第三季財報電話會議。我叫雪莉，今天我將擔任你們的會議接線生。（操作員說明）再次提醒，本次電話會議正在錄音。

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

現在我將把電話交給投資人關係副總裁李成先生。請繼續。

Thank you, Sherry, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the third quarter 2018. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

謝謝你，雪莉，大家下午好。今天股市收盤後不久，我們發布了 2018 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: Robin Washington, Executive Vice President and Chief Financial Officer; Laura Hamill, Executive Vice President, Worldwide Commercial Operations; John McHutchison, Chief Scientific Officer and Head of Research and Development; and John Milligan, President and Chief Executive Officer.

今天電話會議的發言人有：執行副總裁兼財務長 Robin Washington；執行副總裁兼全球商業營運負責人 Laura Hamill；首席科學官兼研發主管 John McHutchison；以及總裁兼執行長 John Milligan。

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 Robin.

現在我會把通話轉給羅賓。

Thank you, Sung, and good afternoon, everyone. We are pleased to share our financial results for the third quarter of 2018. Before I get into the financial results and commercial highlights for the quarter, I'd like to welcome Laura Hamill, who recently joined Gilead as Executive Vice President, Worldwide Commercial Operations. We're glad to have this key position filled and are excited to have Laura on our team. Laura is quickly becoming familiar with our business and has already provided significant commercial expertise on several strategic fronts. You'll hear from Laura in a few minutes, followed by John McHutchison with an update on our R&D efforts, and then John Milligan with a few closing comments.

謝謝宋，大家午安。我們很高興與大家分享2018年第三季的財務表現。在介紹本季度的財務業績和商業亮點之前，我想歡迎勞拉·哈米爾 (Laura Hamill)，她最近加入吉利德公司，擔任全球商業營運執行副總裁。我們很高興這個關鍵職位有人擔任，也很高興勞拉加入我們的團隊。勞拉很快就熟悉了我們的業務，並在多個策略方面提供了重要的商業專業知識。幾分鐘後您將聽到勞拉的發言，隨後是約翰·麥克哈奇森介紹我們的研發工作進展，最後是約翰·米利根作總結發言。

We had very strong execution in the third quarter, during which our HIV franchise achieved record quarterly sales; HCV revenues continued to be more predictable and in line with our expectations; and further progress was made in cell therapy, including the approval of Yescarta in Europe. Total revenues for the third quarter were $5.6 billion, with non-GAAP diluted earnings per share of $1.84. This compares to total revenues of $6.5 billion and non-GAAP diluted earnings per share of $2.27 for the same period last year.

我們在第三季度取得了非常強勁的業績，其中 HIV 產品線實現了創紀錄的季度銷售額；HCV 收入繼續保持穩定，符合我們的預期；細胞療法也取得了進一步進展，包括 Yescarta 在歐洲獲得批准。第三季總營收為 56 億美元，非 GAAP 稀釋後每股收益為 1.84 美元。相比之下，去年同期總收入為 65 億美元，非 GAAP 稀釋後每股收益為 2.27 美元。

Starting with HIV, product sales for the third quarter were $3.7 billion, up 12% year-over-year and 2% sequentially. The year-over-year increase was primarily due to the continued strong uptake of Genvoya and Odefsey and the rapid adoption of Biktarvy. With 19% year-over-year revenue growth and 11% year-over-year prescription growth, our U.S. HIV business continues to reflect strong, underlying demand for Descovy-based regimen, which now account for 74% of Gilead's total U.S. HIV prescription volume. Sequentially, U.S. HIV sales were up 5%, reflecting strong demand for Biktarvy.

以 HIV 產品為例，第三季銷售額為 37 億美元，年增 12%，季增 2%。同比成長主要歸功於 Genvoya 和 Odefsey 的持續強勁成長以及 Biktarvy 的快速普及。我們的美國 HIV 業務收入年增 19%，處方量年增 11%，繼續反映出市場對基於 Descovy 療法的強勁潛在需求，該療法目前佔吉利德美國 HIV 處方總量的 74%。美國 HIV 藥物銷售額較上季成長 5%，反映出市場對 Biktarvy 的強勁需求。

Payer mix in the third quarter was similar to the second quarter, where it was approximately equally split between private pay and government segments. In the second full quarter since its FDA approval in February, Biktarvy generated $375 million in sales in the U.S., becoming the #1 prescribed regimen for both treatment-naïve and switch patients. Biktarvy is on track to overtake Genvoya as of the most successful launch in HIV history, as measured by the first 12 months of product sales. Approximately 85% of the Biktarvy's U.S. prescription came from switches. Of these switches, approximately 1/4 came from regimens containing dolutegravir.

第三季的支付方組成與第二季類似，私人支付和政府支付部分大致平分秋色。自 2 月獲得 FDA 批准以來的第二個完整季度，Biktarvy 在美國的銷售額達到 3.75 億美元，成為初治患者和轉診患者處方量最高的治療方案。根據產品上市前 12 個月的銷售額衡量，Biktarvy 預計將超越 Genvoya，成為 HIV 史上最成功的上市產品。Biktarvy 在美國的處方量約有 85% 來自轉換。在這些轉換中，約有 1/4 來自含有多替拉韋的治療方案。

Truvada for PrEP continued to grow. We estimate that more than 193,000 individuals were taking Truvada for PrEP as we exited the quarter. Early performance indicators for the HIV prevention and Truvada for PrEP television campaign launched in the second quarter are encouraging. Since the launch of these campaigns, we've seen active engagement with campaign-related websites and a nearly 50% increase in the number of weekly new subscribers compared to the pre-campaign averages earlier in the year.

Truvada 用於 PrEP 的銷售持續成長。據我們估計，截至本季末，有超過 193,000 人正在服用 Truvada 進行 PrEP。第二季啟動的愛滋病預防和 Truvada PrEP 電視宣傳活動的早期績效指標令人鼓舞。自從這些活動推出以來，我們看到與活動相關的網站獲得了積極的互動，每週新增訂閱用戶數量與今年早些時候活動開始前的平均水平相比增長了近 50%。

Turning to Europe, HIV sales were down 11% year-over-year, primarily due to the availability of generics in several markets. The decline was partially offset by the continued uptake of our Descovy-based regimen, which now comprise approximately 70% of our HIV product revenues in Europe. As anticipated, we saw a sequential decline in sales in the third quarter, primarily due to the additional impact of generics in certain countries and the seasonal impact of holiday schedules in various countries. To date, in some countries, the impact from generics has not been as significant as expected.

再來看歐洲，HIV 藥物的銷售額較去年同期下降了 11%，這主要是由於多個市場出現了仿製藥。下滑部分被我們基於 Descovy 的治療方案的持續推廣所抵消，該方案目前約占我們在歐洲 HIV 產品收入的 70%。正如預期的那樣，第三季度銷售額環比下降，這主要是由於某些國家仿製藥的額外影響以及各國假期安排的季節性影響。迄今為止，在一些國家，仿製藥的影響還沒有達到預期的程度。

Since receiving marketing authorization from the European Commission in June, Biktarvy has launched in Germany and some of the smaller countries in the EU. In Germany, we are seeing great early uptake where Biktarvy is tracking at least as well as Genvoya for the same period after approval. Also, Biktarvy is already among the top 5 most prescribed regimens for both treatment-naïve and switch patients, with about 1/3 of the switches coming from dolutegravir-containing regimens. Genvoya remained the #1 prescribed regimen for treatment-naïve and switch patients in the EU 5 collectively for the sixth consecutive quarter.

自 6 月獲得歐盟委員會的上市許可以來，Biktarvy 已在德國和歐盟一些較小的國家上市。在德國，我們看到 Biktarvy 在批准後的早期階段取得了巨大的成功，其表現至少與 Genvoya 一樣出色。此外，Biktarvy 已躋身於初治患者和換藥患者處方量排名前 5 名的治療方案之列，其中約有 1/3 的換藥患者來自含有多替拉韋的治療方案。Genvoya 連續第六個季度仍然是歐盟 5 國（歐盟 5 國）初治患者和轉診患者處方量排名第一的治療方案。

Turning to HIV, product sales for the third quarter were $902 million, down 59% year-over-year and down 10% sequentially. To date, our performance in the HCV market continue to align with our expectations of gradual sequential decline, with fewer patients seeking treatment. In September, we announced plans to launch authorized generic versions of Epclusa and Harvoni in the United States in January 2019 through a newly created subsidiary, Asegua Therapeutics LLC. The list prices of the authorized generics will be comparable to the current net prices of the branded version. We believe these authorized generics could reduce out-of-pocket expenses for patients, increase pricing transparency and open up access to our HCV medicines for patients covered by Medicaid. This solution allows us to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the health care system or our business.

再來看 HIV 產品，第三季銷售額為 9.02 億美元，年減 59%，季減 10%。迄今為止，我們在丙型肝炎市場的表現繼續符合我們對逐步連續下降的預期，尋求治療的患者人數減少。9 月，我們宣布計劃於 2019 年 1 月透過新成立的子公司 Asegua Therapeutics LLC 在美國推出 Epclusa 和 Harvoni 的授權仿製藥版本。授權仿製藥的標價將與品牌藥目前的淨價相當。我們相信，這些獲得授權的仿製藥可以降低患者的自付費用，提高價格透明度，並為參加醫療補助計劃的患者提供獲得我們丙型肝炎藥物的機會。此方案使我們能夠快速推出價格較低的丙型肝炎藥物替代品，而不會對醫療保健系統或我們的業務造成重大干擾。

Turning to our cell therapy franchise. Sales of Yescarta were $75 million for the third quarter, up 10% sequentially. We are pleased with the progress we've made with Yescarta since its approval by the U.S. FDA 1 year ago. We now have 64 centers certified to provide treatment for Yescarta. As we continue to see patient inflows at certified centers, we have also observed variability in volume as some centers enthusiastically embrace this novel therapy and others adopt treatment more slowly. We've turned our focus to working with centers to enhance patient flows. We are also educating community oncologists about cell therapy and how they can connect their patients to cancer centers for appropriate treatment. We expect to see continued demand as our certified centers gain broader experience with Yescarta and community oncologists become increasingly aware of this lifesaving therapy.

接下來，我們來談談細胞療法業務。Yescarta 第三季銷售額為 7,500 萬美元，季增 10%。自從 Yescarta 一年前獲得美國 FDA 批准以來，我們對它的進展感到滿意。目前我們有 64 個中心獲得認證，可以提供 Yescarta 治療。隨著認證中心的患者人數不斷增加，我們也觀察到患者數量存在差異，因為一些中心熱情地接受這種新療法，而另一些中心則採取較慢的治療速度。我們已將重點轉向與各中心合作，以改善患者就診流程。我們也正在向社區腫瘤醫師普及細胞療法知識，以及如何幫助他們的病人聯繫癌症中心接受適當的治療。我們預計，隨著我們認證中心在使用 Yescarta 方面累積更廣泛的經驗，以及社區腫瘤醫師對這種救命療法的認識不斷加深，市場需求將會持續增長。

Recently, CMS approved an NTAP, New Technology Add-On Payment, to assist the reimbursement of CAR T therapy within the hospital setting, while we await the creation of a CAR T-specific DRG through CMS. We're very encouraged with the speed in which CMS has recognized the value of Yescarta for cancer patients who have run out of treatment options in relapsed, refractory DLBCL. We look forward to working with CMS to create a dedicated DRG code, reflective of the value Yescarta brings to patients.

最近，CMS 批准了 NTAP（新技術附加支付），以幫助在醫院環境中報銷 CAR T 療法，同時我們等待 CMS 創建 CAR T 特定 DRG。CMS 如此迅速地認可 Yescarta 對復發性、難治性 DLBCL 癌症患者的價值，我們感到非常鼓舞。我們期待與 CMS 合作，創建一個專門的 DRG 代碼，以反映 Yescarta 為患者帶來的價值。

As I previously mentioned, Yescarta was approved in the EU towards the end of August. We are working diligently across Europe to certify approximately 20 centers by the end of 2018. We are pleased with the progress and commercial performance seen to date with Yescarta, which is consistent with our expectations. Going forward, we anticipate a steady and measured launch as reimbursement, referrals and center logistics improve to accommodate more patients.

正如我之前提到的，Yescarta 在 8 月底獲得了歐盟的批准。我們正在歐洲各地努力工作，爭取在 2018 年底前認證約 20 個中心。我們對 Yescarta 目前的進展和商業表現感到滿意，這與我們的預期相符。展望未來，隨著報銷、轉診和中心後勤的改善，我們將穩步推進，以容納更多患者。

Turning to our cardiovascular products, Letairis and Ranexa generated sales of $241 million and $178 million respectively in the third quarter. While the U.S. patent for ambrisentan, the active agent in Letairis, expired in July of this year, we have not seen any impact to our sales as a result of the loss of exclusivity because the single shared REMS program necessary to allow generic ambrisentan to launch has not yet been FDA-approved. There is no specific PDUFA date associated with this approval and the timeline for FDA action is unknown. As we look ahead, we anticipate mature cells to continue for the remainder of this year. However, cells beyond this timeframe are uncertain.

再來看我們的心血管產品，Letairis 和 Ranexa 在第三季分別創造了 2.41 億美元和 1.78 億美元的銷售額。雖然 Letairis 的活性成分安立生坦的美國專利已於今年 7 月到期，但由於允許仿製藥安立生坦上市所需的單一共享 REMS 計劃尚未獲得 FDA 批准，因此我們尚未看到因失去獨佔權而對我們的銷售產生任何影響。此批准沒有具體的PDUFA日期，FDA採取行動的時間表也未知。展望未來，我們預計成熟細胞將在今年剩餘時間內持續生長。然而，超出此時間範圍的細胞狀況尚不確定。

Now turning to expenses. Non-GAAP R&D expenses were $844 million for the third quarter, up 13% compared to the same period last year. Non-GAAP SG&A expenses were $852 million for the third quarter, up 6% compared to the same period last year. The increases in both non-GAAP R&D expenses and SG&A expenses were primarily due to higher costs to support the growth of our business following the acquisition of Kite. Our non-GAAP effective tax rate in the third quarter was 19.9% compared to 25.7% in the same period last year, primarily due to reduction of the U.S. corporate tax rate as a result of tax reform. On a sequential basis, our non-GAAP effective tax rate was higher compared to the second quarter rate of 13.4% due to a favorable settlement of a tax examination in the second quarter.

現在來說說費用。第三季非GAAP研發費用為8.44億美元，比去年同期成長13%。第三季非GAAP銷售、管理及行政費用為8.52億美元，較去年同期成長6%。非GAAP研發費用和銷售、管理及行政費用的增加主要是由於收購Kite後，為了支持業務成長而增加的成本。第三季度，我們的非GAAP有效稅率為19.9%，而去年同期為25.7%，主要是由於稅制改革導緻美國企業稅率降低。與第二季 13.4% 的稅率相比，本季非 GAAP 實際稅率有所上升，這是由於第二季稅務審查的和解結果較為有利。

Moving to our balance sheet. As of September 30, 2018, we had $30.8 billion of cash and investments. During the third quarter, we generated $2.2 billion in operating cash flow, repaid $1.8 billion senior notes upon maturity, paid cash dividends of $742 million, and repurchased approximately 6 million shares of stock for $449 million. The year is progressing consistent with our expectations, with the exception of the durability of Letairis revenues and the lower impact of HIV generics. The combined benefit from these 2 exceptions is approximately $400 million. Therefore, we are raising our full year net product sales guidance. Net product sales are expected to be in the range of $20.8 billion to $21.3 billion. Our guidance is subject to a number of uncertainties, which are outlined in Slide 35 of our earnings call presentation. For the full year, our non-GAAP effective tax rate is expected to be in the range of 18% to 20%. All other components of our guidance remained unchanged.

接下來來看看我們的資產負債表。截至 2018 年 9 月 30 日，我們擁有 308 億美元的現金和投資。第三季度，我們產生了 22 億美元的營運現金流，償還了到期的 18 億美元高級票據，支付了 7.42 億美元的現金股息，並以 4.49 億美元的價格回購了約 600 萬股股票。今年的發展與我們的預期一致，只是 Letairis 的收入持續性以及 HIV 仿製藥的影響較小。這兩項例外措施帶來的總計收益約為 4 億美元。因此，我們上調了全年淨產品銷售額預期。預計淨產品銷售額將在 208 億美元至 213 億美元之間。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第 35 頁中列出。預計全年非GAAP有效稅率將在18%至20%之間。我們指導方針的其他所有部分保持不變。

I will now turn the call over to Laura.

現在我將把通話轉給勞拉。

Thank you, Robin and good afternoon. I'm thrilled to be part of the Gilead team and appreciate how welcoming everyone has been during my first 6 weeks as I'm getting to know the critical success factors for our current and future therapies. I've had the opportunity to learn more about Gilead's portfolio by participating in several therapeutic advisory board meetings, scientific conferences, visiting some of our cancer institutions that are providing treatments with Yescarta and engaging with many passionate Gilead employees.

謝謝你，羅賓，下午好。我很高興能成為吉利德團隊的一員，也很感謝大家在我加入的頭六週內給予的熱情歡迎，讓我有機會了解我們目前和未來療法的關鍵成功因素。我有機會透過參加多次治療諮詢委員會會議、科學會議、參觀一些使用 Yescarta 進行治療的癌症機構以及與許多充滿熱情的吉利德員工交流，更多地了解了吉利德的產品組合。

The commercial and field teams have a deep commitment to support health care providers as they meet the needs of patients around the world. It's a privilege to be joining Gilead at this time, with the introduction of Yescarta as well as Biktarvy, which is on track for an outstanding launch. We are continuing to shift treatment paradigms. I also want to acknowledge the innovative approach the team has taken in the United States to increase access to our hepatitis C treatment. Next year our subsidiary, Asegua, will launch authorized generic versions of Harvoni and Epclusa, a medication we believe has a unique clinical profile as a pan-genotypic and pan-fibrotic single-tablet regimen. As we prepare for our next set of launches, we will bring our deep expertise in building new markets, as well as capabilities to compete in existing markets with many therapeutic options. The teams around the world are motivated by Gilead's mission to bring innovative medicines to more than 13 million patients with life-threatening illnesses.

商業團隊和現場團隊致力於為醫療保健提供者提供支持，以滿足世界各地患者的需求。在這個時刻加入吉利德公司是我的榮幸，因為Yescarta和Biktarvy都即將上市，而且Biktarvy的上市也進展順利，有望取得巨大成功。我們正在不斷轉變治療模式。我還要讚揚該團隊在美國採取的創新方法，以增加丙型肝炎治療的可近性。明年，我們的子公司 Asegua 將推出 Harvoni 和 Epclusa 的授權仿製藥版本。我們認為，Epclusa 是一種具有獨特臨床特徵的泛基因型和泛纖維化單片療法。在籌備下一批產品上市之際，我們將憑藉在開拓新市場方面的深厚專業知識，以及在現有市場中透過多種治療方案參與競爭的能力，為市場帶來更多機會。全球各地的團隊都受到吉利德使命的激勵，即為超過 1300 萬名患有危及生命的疾病的患者帶來創新藥物。

I look forward to sharing our commercial progress with you during our next quarterly update, and will now turn the call over to John McHutchison.

我期待在下次季度更新會議上與大家分享我們的商業進展，現在我將把電話交給約翰·麥克哈奇森。

Thank you, Laura. Welcome, and thank you everybody for joining us today. I'd like to start by talking about the progress we are making across our latter-stage pipeline. As we enter the final quarter of the year and look ahead to 2019, we anticipate readouts from 5 Phase III studies over the next 9 months. The American College of Rheumatology meeting finished yesterday in Chicago, so I'll begin with some commentary about our work in the area of inflammation, starting with filgotinib, which as you know, is the selective JAK1 inhibitor.

謝謝你，勞拉。歡迎各位，感謝大家今天蒞臨。我想先談談我們在後期研發流程中所取得的進展。隨著我們進入今年的最後一個季度並展望 2019 年，我們預計在接下來的 9 個月內將公佈 5 項 III 期研究的結果。美國風濕病學會會議昨天在芝加哥結束，所以我將首先對我們在發炎領域的工作進行一些評論，首先是filgotinib，如您所知，它是一種選擇性JAK1抑制劑。

Last month, we announced positive results from FINCH 2, the first of 3 Phase III studies to readout in patients with rheumatoid arthritis. FINCH 2 compared filgotinib to placebo, each added to conventional disease modifying antirheumatic drugs, or DMARD, in 423 patients who have previously not had an adequate response to biologic therapy. Filgotinib was generally well-tolerated and met the study's primary endpoint in terms of the proportion of patients achieving an ACR20 at week 12. In addition, key secondary endpoints including ACR50 and 70 responses in the rates of low disease activity and clinical remission were all higher with filgotinib compared to placebo. Importantly for these endpoints, we also noted a dose dependency as efficacy rates were numerically higher with the 200-milligram once-daily dose of filgotinib compared to the 100-milligram daily dose.

上個月，我們公佈了 FINCH 2 的正面結果，這是針對類風濕性關節炎患者的 3 項 III 期研究中的第一項。FINCH 2 將 filgotinib 與安慰劑進行比較，兩者均添加到傳統的疾病修飾抗風濕藥物 (DMARD) 中，研究對象為 423 名先前對生物療法沒有充分反應的患者。菲戈替尼整體耐受性良好，並達到了研究的主要終點，即在第 12 週達到 ACR20 的患者比例。此外，與安慰劑相比，filgotinib 治療組的關鍵次要終點指標（包括 ACR50 和 70 反應率、低疾病活動率和臨床緩解率）均較高。對於這些終點而言，我們也注意到劑量依賴性，因為與每日 100 毫克劑量相比，每日一次 200 毫克劑量的 filgotinib 的療效在數值上更高。

The initial readout of the first Phase III data added to our excitement about the potential of filgotinib, obviously. We expect results from 2 other Phase III studies of filgotinib, FINCH 1 and FINCH 3, to be available in the first quarter of next year and is supported by the data to form the basis of our filings for regulatory approvals globally. As a reminder, FINCH 1 is a 52-week randomized study comparing both doses of filgotinib plus methotrexate, to atezolizumab plus methotrexate, and to methotrexate alone in patients who have previously had an inadequate response to methotrexate. FINCH 3 is a 52-week randomized study comparing filgotinib alone to methotrexate alone and to the combination of filgotinib plus methotrexate in methotrexate-naïve patients.

顯然，首個 III 期臨床試驗數據的初步結果更加激發了我們對 filgotinib 潛力的興奮之情。我們預計 filgotinib 的另外兩項 III 期研究 FINCH 1 和 FINCH 3 的結果將於明年第一季公佈，這些數據將作為我們向全球監管機構申請批准的基礎。提醒一下，FINCH 1 是一項為期 52 週的隨機研究，比較了兩種劑量的 filgotinib 加甲氨蝶呤、atezolizumab 加甲氨蝶呤以及單獨使用甲氨蝶呤治療對先前對甲氨蝶呤反應不足的患者的效果。FINCH 3 是一項為期 52 週的隨機研究，比較了在未接受過甲氨蝶呤治療的患者中，單獨使用 filgotinib 與單獨使用甲氨蝶呤以及 filgotinib 加甲氨蝶呤聯合用藥的療效。

Now our ability to file the NDA for filgotinib is dependent on data from the MANTA study. As you may recall, MANTA is a safety study in men with ulcerative colitis that was requested by the FDA and is designed to address nonclinical findings observed in preclinical animal study. Because our Phase III FINCH trials have enrolled more rapidly than anticipated, enrollment in MANTA will likely be the rate-limiting factor to filing an NDA in the United States. While we have been making every effort to expedite enrollment, the full impact of the effort and their impact on the overall timeline are uncertain at this time.

現在，我們能否提交 filgotinib 的新藥申請取決於 MANTA 研究的數據。您可能還記得，MANTA 是一項針對潰瘍性結腸炎男性患者的安全研究，由 FDA 要求開展，旨在解決臨床前動物研究中觀察到的非臨床發現。由於我們的 III 期 FINCH 試驗招募速度比預期更快，MANTA 的招募速度很可能成為在美國提交 NDA 的限制因素。雖然我們一直在盡一切努力加快招生速度，但目前尚不確定這些努力的全面效果及其對整體時間表的影響。

Results from the EQUATOR study, a Phase II trial of filgotinib, in 131 adults with active psoriatic arthritis were presented this week at ACR in a plenary session and concurrently published in The Lancet. The study also achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at week 16. The study demonstrated an impressive ACR20 response of 80% for filgotinib 200 milligrams daily versus 33% for placebo. The ACR50 and ACR70 responses were also significantly higher for filgotinib compared to placebo. Based upon the strength of these data, we are excited to be initiating plans for our Phase III program and are enthusiastic about what this may mean for people living with psoriatic arthritis and whose disease has not responded to prior treatment.

本週，在 ACR 的全體會議上公佈了 filgotinib 的 II 期試驗 EQUATOR 研究結果，該試驗針對 131 名患有活動性乾癬性關節炎的成年人。同時，研究結果也發表在《刺胳針》雜誌上。該研究在第 16 週也達到了主要終點，即銀屑病關節炎的跡象和症狀有所改善。研究顯示，每天服用 200 毫克 filgotinib 的 ACR20 緩解率高達 80%，而安慰劑組的緩解率為 33%。與安慰劑相比，filgotinib 的 ACR50 和 ACR70 反應也明顯較高。基於這些數據的強大力量，我們很高興啟動我們的 III 期計畫計劃，並對這可能對患有銀屑病關節炎且疾病對先前治療沒有反應的人們意味著什麼感到興奮。

Last month, we announced that filgotinib met its primary efficacy endpoint in the Phase II TORTUGA study in adults with moderately to severely active ankylosing spondylitis. Patients treated with filgotinib achieved significantly greater improvement in the ankylosing spondylitis disease activity score at week 12 compared to placebo. These results, which were also published in The Lancet this week, compares favorably to those seen with other known DMARDs commonly used to treat ankylosing spondylitis patients. We'll determine the next steps for the program in the coming months. Finally, in the inflammation therapeutic area, I'm pleased to share that a Phase II study evaluating 3 investigational therapies: Filgotinib; GS-9876, a Syk inhibitor; and tirabrutinib, a BTK inhibitor, in patients with active Sjogren’s syndrome has fully enrolled 140 patients.

上個月，我們宣布 filgotinib 在針對中度至重度活動性僵直性脊椎炎成年患者的 II 期 TORTUGA 研究中達到了主要療效終點。與安慰劑組相比，接受 filgotinib 治療的患者在第 12 週時僵直性脊椎炎疾病活動評分顯著改善。這些結果也於本週發表在《柳葉刀》上，與目前已知用於治療僵直性脊椎炎患者的 DMARD 相比，其療效較佳。我們將在未來幾個月內確定該專案的下一步步驟。最後，在發炎治療領域，我很高興地宣布，一項評估三種研究性療法（Filgotinib、GS-9876（一種 Syk 抑制劑）和 tirabrutinib（一種 BTK 抑制劑））治療活動性乾燥症患者的 II 期研究已完成 140 名患者的入組。

Now turning to HIV, we presented 96-week data at ID Week in San Francisco earlier this month from an ongoing Phase III study evaluating the safety and efficacy of Biktarvy for the treatment of HIV infection in treatment-naïve adults. The data at 2 years confirmed the efficacy and safety profile of Biktarvy and shows that Biktarvy continued to be well-tolerated with no cases of treatment-emergent resistance.

現在轉向 HIV，我們在本月初於舊金山舉行的 ID Week 會議上公佈了一項正在進行的 III 期研究的 96 週數據，該研究評估了 Biktarvy 治療未經治療的成年人 HIV 感染的安全性和有效性。2 年的數據證實了 Biktarvy 的療效和安全性，並顯示 Biktarvy 的耐受性良好，沒有出現治療抗藥性病例。

Moving on to liver diseases, The Liver Meeting will be held in San Francisco early next month, where we will present data from more than 50 abstracts across our programs in NASH, primary sclerosing cholangitis, hepatitis B and hepatitis C. In NASH, we are advancing multiple investigational compounds for the treatment of advanced fibrosis, that is patients with Stage III and Stage IV fibrosis. Individuals with these advanced stages of fibrosis are at a significantly higher risk of liver-related mortality. The data being presented further characterize the potential role of 3 compounds we have in development: Our FXR agonist, GS-9674; our ASK1 inhibitor, selonsertib; and our ACC inhibitor, GS-0976. We will also present baseline data from STELLAR 3 and STELLAR 4, our 2 ongoing Phase III trials evaluating selonsertib as monotherapy has described the potential role and sequence of noninvasive tests and their ability to diagnose advanced fibrosis. Currently, liver biopsy, which is the standard method to diagnose advanced fibrosis, poses challenges to timely and efficient diagnosis and treatment of patients with this disease.

接下來談談肝臟疾病。下個月初，肝臟疾病會議將在舊金山舉行，屆時我們將展示來自我們NASH、原發性硬化性膽管炎、乙型肝炎和丙型肝炎等項目50多篇摘要的數據。在NASH方面，我們正在推動多種用於治療晚期纖維化（即III期和IV期纖維化患者）的在研化合物。處於纖維化晚期階段的個體，其肝臟相關死亡風險顯著增加。所展示的數據進一步描述了我們正在開發的 3 種化合物的潛在作用：我們的 FXR 激動劑 GS-9674；我們的 ASK1 抑制劑 selonsertib；以及我們的 ACC 抑制劑 GS-0976。我們還將展示 STELLAR 3 和 STELLAR 4 的基線數據，我們正在進行的 2 項 III 期試驗評估了 selonsertib 作為單藥療法，描述了非侵入性檢查的潛在作用和順序及其診斷晚期纖維化的能力。目前，肝臟切片檢查是診斷晚期肝纖維化的標準方法，但對於及時有效診斷和治療患有這種疾病的患者來說，肝臟活檢帶來了挑戰。

Before we move on from NASH, I'd like to remind you that we anticipate data readouts from STELLAR 3 and STELLAR 4 in the first half of 2019. We are also pleased to share that the Phase IIb ATLAS study of various combination 2-drug regimen in patients with NASH and advanced fibrosis has now closed screening. We are presenting data from a Phase II trial evaluating our FXR agonists in primary sclerosing cholangitis. This is a rare, serious disease that causes progressive inflammation and scarring of the bile duct, which can lead to cirrhosis and its complications, including liver failure. There are currently no effective treatment options available for these patients.

在結束 NASH 的討論之前，我想提醒大家，我們預計在 2019 年上半年獲得 STELLAR 3 和 STELLAR 4 的數據讀數。我們也很高興地宣布，針對 NASH 和晚期纖維化患者，針對各種 2 藥聯合療法的 IIb 期 ATLAS 研究現已結束篩選。我們正在展示一項 II 期試驗的數據，該試驗評估了我們的 FXR 激動劑在原發性硬化性膽管炎中的療效。這是一種罕見的嚴重疾病，會導致膽管進行性發炎和疤痕形成，進而導致肝硬化及其併發症，包括肝衰竭。目前尚無針對這些患者的有效治療方案。

And finally at The Liver Meeting, we will also share data from Gilead's ongoing programs directed at achieving functional cure to chronic hepatitis B-infected patients. GS-9688, an investigational, oral selective toll-like receptor 8 agonist, is the subject of several studies to be presented, including the first in human and Phase Ib results evaluating the drug in patients with chronic hepatitis B.

最後，在肝臟會議上，我們還將分享吉利德正在進行的旨在實現慢性乙型肝炎感染患者功能性治癒的計畫的數據。GS-9688 是一種正在研究的口服選擇性 Toll 樣受體 8 激動劑，目前正在進行多項研究，包括首次人體試驗和 Ib 期臨床試驗，以評估該藥物對慢性乙型肝炎患者的療效。

Turning to cell therapy, we continue to make great scientific progress also during the quarter. In August, we announced the European Commission granted marketing authorization for Yescarta as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after to 2 or more lines of systemic therapy. We are making progress in reaching patients with other forms of B-cell malignancies also with Yescarta and KTE-X19. Registrational Phase II trials are ongoing with Yescarta in relapsed and refractory indolent NHL, non-Hodgkin's lymphoma, and with KTE-X19 in relapsed and refractory mantle cell lymphoma and adult ALL. We expect to announce initial data and trial update from our cell therapy program at the American Society of Hematology Annual Meeting, ASH, which begins December 1 in San Diego. We will share more information with you next month when those meeting abstracts are published.

在細胞療法方面，我們本季也持續取得了巨大的科學進展。8 月，我們宣布歐盟委員會批准 Yescarta 上市，用於治療接受 2 線或以上全身性治療後復發或難治性瀰漫性大 B 細胞淋巴瘤和原發性縱隔大 B 細胞淋巴瘤的成年患者。我們使用 Yescarta 和 KTE-X19 治療其他類型的 B 細胞惡性腫瘤患者也取得了進展。Yescarta 正在進行復發和難治性惰性 NHL、非何杰金氏淋巴瘤的註冊性 II 期試驗，KTE-X19 正在進行復發和難治性套細胞淋巴瘤和成人 ALL 的註冊性 II 期試驗。我們預計將於 12 月 1 日在聖地牙哥舉行的美國血液學會年會 (ASH) 上公佈我們細胞療法計畫的初步數據和試驗進展。下個月會議摘要公佈後，我們將與您分享更多資訊。

Separately in oncology, we discontinued the development of Andecaliximab, an investigational, anti-MMP9 antibody in gastric cancer, after a Phase III study showed a lack of overall survival benefit to primary endpoint. These data are consistent with the results we're seeing with Andecaliximab and other therapeutic programs.

在腫瘤學領域，我們停止了安德卡利昔單抗（一種用於治療胃癌的在研抗 MMP9 抗體）的研發，先前一項 III 期研究顯示，該藥物在主要終點方面未能帶來總生存期獲益。這些數據與我們使用安地卡利昔單抗和其他治療方案所看到的結果一致。

We continue to pursue additional technologies and approaches that will allow us to remain the leader in cell therapy. Earlier this month, we announced another research collaboration and license agreement with HiFiBio Therapeutics to develop technologies supporting the discovery of neoantigen-reactive T-cell receptors for the potential treatment of various cancers, particularly solid tumors. Through this collaboration, we intend to adapt HiFiBio's propriety single-cell technology platform to create a high-throughput approach that will potentially allow for in-depth screening of TCR repertoires from patient samples to identify those shared antigen and neoantigen TCRs for use in adoptive T-cell therapy. Neoantigens arise from tumor-specific mutations that are unique to each patient's cancer, upping the potential for more targeted antitumor activity. This area of research has the potential to transform the way we might be able to treat many solid tumors.

我們將繼續探索更多技術和方法，以保持我們在細胞治療領域的領先地位。本月初，我們宣布與 HiFiBio Therapeutics 達成另一項研究合作和授權協議，以開發支持發現新抗原反應性 T 細胞受體的技術，用於潛在治療各種癌症，特別是實體瘤。透過此次合作，我們計劃對 HiFiBio 的專有單細胞技術平台進行改造，以創建一個高通量方法，從而有可能對患者樣本中的 TCR 庫進行深入篩選，以識別那些共享抗原和新抗原 TCR，用於過繼性 T 細胞療法。新抗原源自於腫瘤特異性突變，每位患者的癌症都獨一無二，進而提高了更有針對性的抗腫瘤活性。這一研究領域有可能改變我們治療許多實體腫瘤的方式。

I would like to also note that these kinds of scientific collaborations are not limited to cell therapy. In September, we entered into a strategic collaboration with Precision BioSciences to develop therapies targeting the in vivo elimination of HPV or hepatitis B virus, with Precision's proprietary genome editing platform, Arcus. We are committed to developing therapies that achieve a functional cure for patients with chronic hepatitis B virus. We're excited about the potential of genome editing and Precision's Arcus technology, which has already demonstrated promising in vitro activity.

我還想指出，這類科學合作並不限於細胞療法。9 月，我們與 Precision BioSciences 達成策略合作，利用 Precision 的專有基因組編輯平台 Arcus，開發針對體內消除 HPV 或乙型肝炎病毒的療法。我們致力於研發能夠使慢性B型肝炎病毒感染患者達到功能性治癒的療法。我們對基因組編輯的潛力以及Precision公司的Arcus技術感到興奮，該技術已經展現出良好的體外活性。

We have achieved a great deal across our R&D organization this quarter, and I am confident we will continue to make significant progress throughout the rest of the year. I'm excited about the strength and diversity of our pipeline, as described today, the breakthrough work we are doing in cell therapy, and the cutting-edge research we are doing to advance curative therapies both for hepatitis B and HIV-infected patients. I want to take the opportunity to thank our R&D organization and all of our employees for their incredible focus, hard work and execution. So thank you all.

本季度，我們的研發部門取得了巨大成就，我相信在今年餘下的時間裡，我們將繼續取得重大進展。我對我們今天所描述的產品線的實力和多樣性感到興奮，我們在細胞療法領域取得的突破性進展，以及我們為推進乙肝和愛滋病毒感染患者的治癒療法而進行的尖端研究。我想藉此機會感謝我們的研發部門和所有員工，感謝他們令人難以置信的專注、辛勤工作和出色執行力。所以，謝謝大家。

And now, I'd like to turn the call over to John Milligan.

現在，我想把電話交給約翰·米利根。

Thank you, John. Good afternoon, everyone. As we approach the end of the year and head into 2019, we have many reasons to feel confident about the strength of our business and the future of our company. Our long-term leadership in HIV continues. We're having a terrific launch with Biktarvy, which is exceeding our high expectations and is on track to become the most successful ever in HIV through the first year of sales. We also have compelling evidence correlating the use of Truvada for PrEP, with declines in new infections in the United States, further demonstrating its importance as an effective public health intervention in the ongoing effort to meaningfully decrease new infections.

謝謝你，約翰。大家下午好。隨著2019年即將結束，我們即將邁入2019年，我們有許多理由對公司業務的實力和未來充滿信心。我們在愛滋病防治領域的長期領先地位仍在延續。Biktarvy 的上市非常成功，超出了我們的預期，預計在第一年的銷售中成為 HIV 領域最成功的產品。我們也有令人信服的證據表明，使用 Truvada 進行 PrEP 與美國新感染病例的下降有關，這進一步證明了 Truvada 作為一項有效的公共衛生幹預措施在持續努力顯著減少新感染病例方面的重要性。

While great progress has been made in both treatment and prevention over the last 2 decades, we believe there's still plenty of room for innovation in HIV. We're pursuing research that could help patients who have run out of options as a result of viral resistance or who may need less frequent dosing than afforded by a daily pill. And finally, we hope that our research may one day lead to a cure, completely removing the virus from patients once and for all, as we did for patients in HCV.

雖然過去二十年來在治療和預防方面都取得了巨大進步，但我們認為愛滋病領域仍有很大的發展空間。我們正在進行的研究可以幫助那些因病毒抗藥性而無藥可治的患者，或是那些需要比每日服藥頻率更低的給藥頻率的患者。最後，我們希望我們的研究有朝一日能治癒這種疾病，徹底清除患者體內的病毒，就像我們治癒C型肝炎患者一樣。

In HCV, we continue to innovate to expand access and support efforts towards elimination of the virus from the human population. In January, just over 5 years after the launch of Sovaldi, our newly-formed subsidiary, Asegua, will launch authorized generic versions of Epclusa and Harvoni in the United States. We believe this will help reduce out-of-pocket expenses for many patients, increase price transparency and open up access to our HCV medicines for patients covered by Medicaid without disruption to the broader health care environment.

在丙型肝炎領域，我們不斷創新，以擴大治療範圍，並支持消除人類群體中丙型肝炎病毒的努力。今年一月，在 Sovaldi 上市 5 年多後，我們新成立的子公司 Asegua 將在美國推出 Epclusa 和 Harvoni 的授權仿製藥版本。我們相信這將有助於減少許多患者的自付費用，提高價格透明度，並使參加 Medicaid 的患者能夠獲得我們的 HCV 藥物，而不會對更廣泛的醫療保健環境造成乾擾。

One year after the acquisition of Kite, Gilead is the leader in cell therapy and Yescarta access for people with relapsed/refractory DLBCLs is now established in over 60 centers in the United States. Yescarta has shown an unprecedented duration of response in clinical studies and we have now treated nearly 700 patients across clinical trials and commercial use. The high percentage of patients showing a durable response following the single cellular fusion gives us a glimpse into the potential of cellular therapy to radically change the cancer treatment paradigm in the future, perhaps across many different tumor types.

在收購 Kite 一年後，吉利德成為細胞療法領域的領導者，Yescarta 已在美國 60 多個中心用於治療復發/難治性瀰漫性大B細胞淋巴瘤 (DLBCL) 患者。Yescarta 在臨床研究中展現了前所未有的療效持續時間，目前我們已透過臨床試驗和商業用途治療了近 700 名患者。單細胞融合後，相當一部分患者表現出持久的療效，這讓我們得以窺見細胞療法在未來徹底改變癌症治療模式的潛力，或許可以應用於多種不同的腫瘤類型。

Over the last year, we have established 6 technology product-based partnerships that will allow us to build on our leadership position in cell therapy and transform the treatment of cancer. We have a maturing pipeline and are now beginning to see the first of many Phase III readouts of filgotinib in inflammation. We are pleased that the efficacy and safety of filgotinib looks to be consistent with the datasets from the long-term Phase II studies and believe filgotinib shows great promise to help patients in a number of different indications.

過去一年，我們建立了 6 個基於技術產品的合作夥伴關係，這將使我們能夠鞏固在細胞療法領域的領先地位，並改變癌症的治療方式。我們的研發管線日趨成熟，現在開始看到filgotinib在發炎治療方面眾多III期臨床試驗結果中的第一個。我們很高興 filgotinib 的療效和安全性似乎與長期 II 期研究的數據一致，並相信 filgotinib 在幫助患者治療多種不同適應症方面具有巨大潛力。

Finally, Gilead has dedicated enormous resources to understanding the biology and pathology of NASH. These efforts are paying off, with 3 compounds in the clinic, including an extensive array of Phase II combination studies. Next year, we'll see the first Phase III readouts of selonsertib, as the STELLAR 3 and STELLAR 4 clinical studies are completed and unblinded. We look forward to seeing the data and our teams are hard at work preparing for the launch of selonsertib into this brand-new disease area.

最後，吉利德投入了大量資源來了解 NASH 的生物學和病理學。這些努力正在取得成效，目前有 3 種化合物進入臨床試驗階段，其中包括一系列廣泛的 II 期聯合用藥研究。明年，隨著 STELLAR 3 和 STELLAR 4 臨床研究完成並揭盲，我們將看到 selonsertib 的首批 III 期研究結果。我們期待看到相關數據，我們的團隊正在努力準備將 selonsertib 推向這個全新的疾病領域。

The work of Gilead goes on even as I prepare to depart at the end of the year. To everyone who supported us in our mission over the years, thank you. I have every confidence in my team's ability to continue the work of bringing forward therapeutics that dramatically improve lives. To Gilead's more than 11,000 employees, I also want to thank you. It's been a privilege to be your leader for the last 3 years and to work with you for the last 29. It's been deeply gratifying to be part of a company that has brought life-saving treatments to 10 million people around the globe. I look forward to watching the continued evolution of Gilead and the extraordinary things I know you all will accomplish. So let's open it up for questions. Operator?

即使我準備在年底離開，基列的工作仍在繼續。感謝多年來支持我們使命的每一個人。我對我的團隊有能力繼續推進研發能夠顯著改善人們生活的療法充滿信心。我還要感謝吉利德公司的 11,000 多名員工。過去三年能成為你們的領導是我的榮幸，過去29年能與你們共事是我的榮幸。能夠成為一家為全球 1,000 萬人帶來救命療法的公司的一員，我深感欣慰。我期待著見證基列國的持續發展，以及我知道你們所有人將會取得的非凡成就。那麼，就讓我們開始提問吧。操作員？

(Operator Instructions) Our first question comes from Geoff Meacham with Barclays.

（操作員說明）我們的第一個問題來自巴克萊銀行的傑夫·米查姆。

John, I really will miss your leadership and I wanted to add congrats also to Laura on the new role. Just had a few on HIV. If you guys could give us any more perspective on switches to Biktarvy beyond dolutegravir, are you guys seeing switches from generic regimen as well? And then on PrEP, I know you don't have data yet, but what's the initial thought on positioning for Descovy over Truvada? And how do you think that plays out following the Truvada LOE?

約翰，我真的會非常想念你的領導，同時我也想祝賀勞拉履新。剛聽了幾篇關於愛滋病的文章。如果各位能就從多替拉韋（dolutegravir）換成比克塔維（Biktarvy）的情況提供更多見解，你們是否也觀察到從通用藥物療法換用比克塔維的情況？關於 PrEP，我知道你們還沒有相關數據，但你們初步認為 Descovy 相對於 Truvada 的定位如何？那麼，在 Truvada LOE 之後，你認為情況會如何發展？

So in terms of the switches, Geoff, as I mentioned, we are seeing that the majority of the Biktarvy prescriptions are coming from switches, about 85% to be exact. And approximately 1/4 of those are coming from dolutegravir-containing regimens. There's also about 25% coming from Genvoya as well. So there's good overall balance. And then the latter half of your question, Geoff, if you can repeat it?

所以，就轉換而言，Geoff，正如我所提到的，我們看到 Biktarvy 處方的大部分來自轉換，確切地說是大約 85%。其中約有 1/4 來自含多替拉韋的治療方案。此外，還有大約 25% 來自 Genvoya。所以整體比較平衡。傑夫，你問題的後半部分，你能再重複一次嗎？

Descovy.

發現。

Descovy for PrEP.

探索 PrEP。

Descovy for PrEP. So that's John...

探索 PrEP。這就是約翰…

Yes, John here, look, the question of Descovy versus Truvada for PrEP, people who are healthy, which the people who are taking PrEP are, deserve and want the easiest and safest and best-tolerated medication. So that is Descovy. So I think that's a pretty straightforward answer to that question.

是的，我是約翰。聽著，關於Discovy和Truvada在PrEP中的比較，健康的人（也就是服用PrEP的人）應該得到並想要最簡單、最安全、耐受性最好的藥物。這就是 Descovy。所以我覺得這個問題的答案很簡單明了。

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。

On filgotinib, with the Phase III starting to roll out, I was wondering if you could provide your latest views on what you see as the key differentiating features or indications and maybe walk us through your latest plans in how you're thinking about building out a commercial infrastructure in inflammation, particularly with some of the new leadership now in place?

關於filgotinib，隨著III期臨床試驗的開始，我想請您談談您對該藥物關鍵差異化特徵或適應症的最新看法，並介紹一下您在炎症領域構建商業基礎設施方面的最新計劃，尤其是在一些新的領導層到位的情況下？

So I'll start first. So after attending AACR this week and being at the meeting, it's clear that the efficacy that we are generating in multiple inflammatory diseases with filgotinib is as good or if not better than any other drug in the class and equivalent to the biologics. And that holds true for FINCH 2, where we just saw the most difficult patients to treat, biologic non-responders, inadequate responder patients, where our ACR20 rates in people who'd received 3 or more biologics previously was over 70% -- just over 70%. So I think efficacy-wise, we are as good, if not better, than anything else out there in the class. Safety-wise, we continue to see the differentiation, based upon the lab parameters, anemia, the lack of anemia, the lack of effects on platelets. And when we look at other clinical events such as thrombolytic events and other events, we're not seeing any different. We have to see that safety benefit and advantage hold up in the subsequent Phase III clinical programs, the same as the other diseases we're seeing those benefits as well. So I'll hand it over to the other folks about the commercial buildout, et cetera.

那我先開始吧。因此，在本週參加了 AACR 會議之後，很明顯，我們用 filgotinib 在多種發炎性疾病中產生的療效，即使不是比同類其他藥物更好，也至少與它們一樣好，並且與生物製劑相當。FINCH 2 也同樣如此，我們在這裡看到了最難治療的患者，即生物製劑無反應者、反應不足的患者，其中之前接受過 3 種或更多生物製劑治療的患者的 ACR20 率超過 70%——略高於 70%。所以我覺得就功效而言，我們即使不是比同類產品更好，也至少和它們一樣好。從安全性角度來看，我們繼續根據實驗室參數、貧血、無貧血、對血小板無影響等情況來區分。當我們觀察其他臨床事件，例如溶栓事件和其他事件時，我們發現情況並沒有什麼不同。我們必須看到這種安全性和優勢在隨後的 III 期臨床計畫中得到證實，就像我們在其他疾病中也看到了這些益處一樣。所以，關於商業建設等方面的事情，我會交給其他人來處理。

This is Laura. I would say on the commercial structure, we will build a commercial field team that is competitive across all indications and as you know, we are aware of the investment that's necessary to compete in this market and we will be reaching consumers in innovative ways to make sure that they are aware of the profile that we'll be able to bring to the market to help them.

這是勞拉。關於商業架構，我們將組成一支在所有適應症領域都具有競爭力的商業團隊。如您所知，我們深知在這個市場競爭所需的投資，我們將以創新的方式接觸消費者，確保他們了解我們將為市場帶來的產品和服務，從而幫助他們。

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。

John, I'm sure we all heard the emotion in the voice, so we appreciate all the work you've done and for all the years. I guess, my question is, it feels like The Street has 2 uncertainties: One is a bit on hep C; and one is, I guess, to an extent, an update on the new leadership that would give people confidence going forward. Perhaps you can give a comment as to your confidence around the U.S. hep C market stabilizing, whether there's any changes and how the authorized generic helps that, if at all? And then if you can make any comment on where we stand on the leadership change, I think that would help people as well.

約翰，我相信我們都聽出了你聲音裡的情感，所以我們感謝你多年來所做的一切工作。我想問的是，感覺華爾街有兩個不確定因素：一個是C肝疫情；另一個在某種程度上是關於新領導層的最新情況，這將有助於人們增強對未來的信心。您能否就美國丙肝市場趨於穩定的信心發表一下看法，是否存在任何變化，以及授權仿製藥對此有何幫助（如果有的話）？如果您能就我們對領導層更迭的立場發表任何評論，我認為這對其他人也會有所幫助。

Yes, Michael, so let's just -- talking about the U.S. hep C market, what we have seen through the course of the year is a fairly stable pricing environment. But of course, declining patient numbers, particularly in the commercial market and to some extent, the Medicare markets. So we think the authorized generic will actually boost us for the future, because number one, it provides more transparency, which is good for everybody. It will take away some of the pain of the co-pays that are provided, especially into the Medicare population. But most importantly, it'll open up access for us into the Medicaid population, which is the largest growing segment of patients for the future. So we think that all this will enhance our ability to compete for the future and really help stabilize this market going into 2019 and beyond. So all in all, a very positive thing for us. With regard to the CEO search, I really can't say anything specific, other than to say there are many candidates who are very interested. The process is moving along quickly and we certainly hope to have somebody announced before the end of the year.

是的，邁克爾，那麼我們就來談談美國C肝市場吧，我們今年看到的是一個相當穩定的價格環境。當然，患者數量正在下降，尤其是在商業市場，以及在某種程度上，醫療保險市場。所以我們認為授權仿製藥實際上會促進我們未來的發展，因為首先，它提供了更高的透明度，這對每個人都有好處。這將減輕部分自付費用帶來的痛苦，尤其對享有醫療保險的人更是如此。但最重要的是，這將為我們打開進入醫療補助人群的大門，而醫療補助人群是未來成長最快的患者群體。因此，我們認為所有這些都將增強我們未來的競爭力，並真正有助於穩定這個市場，使其在 2019 年及以後保持穩定。總而言之，這對我們來說是一件非常正面的事情。關於CEO的遴選，我真的不能透露任何具體訊息，只能說有很多候選人對此非常感興趣。這個過程進展迅速，我們當然希望在年底前宣佈人選。

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 have one related to some of the Kite programs. I noticed in the slides, you indicated that you'd be making a decision on your BCMA CAR, whether to move into a registrational study in the fourth quarter. I'm just wondering what data you're waiting for to make that decision and how you're going to communicate that decision?

我有一個與某些 Kite 程序相關的問題。我在幻燈片中註意到，您表示將在第四季度決定是否啟動BCMA CAR的註冊研究。我只是想知道你們在等待哪些數據來做決定，以及你們打算如何傳達這個決定？

Michael -- Matt, sorry. Look, yes, it's unchanged. We are waiting for data from the Phase Ib trial, which is looking at escalating dose cohorts for the safety and efficacy in myeloma patients of 585. And then we'll announce the start of a Phase II trial if the data supports that. So no change to what we've said previously and we're in the process of that right now.

麥可——抱歉，是馬特。是的，它沒有改變。我們正在等待 Ib 期試驗的數據，該試驗正在研究 585 名多發性骨髓瘤患者中劑量遞增隊列的安全性和有效性。如果數據支持，我們將宣布啟動二期臨床試驗。所以，我們之前所說的內容沒有改變，我們現在正在處理此事。

Our next question comes from Geoffrey Porges with Leerink.

下一個問題來自 Leerink 的 Geoffrey Porges。

John, I just want to congratulate you on all the accomplishments over those 29 years. I'm sure if you have any free time, John McHutchison might lend you his AO for a bit of travel. I just wanted to ask John McHutchison a little bit about a couple of pipeline contingencies. First you mentioned the MANTA study, and obviously you'll have the 3 FINCH studies by the -- in the first half of the year. Is it possible that, that filing could be delayed until 2020? Or is there any way you could start filing with the clinical data and then append financial data to the filing? And then secondly, will you have a chance to look at the interim data from the combination NASH study and then potentially contemplate pivotal trials for some combination earlier than the 48-week data?

約翰，我只想祝賀你在過去29年裡所取得的所有成就。我相信如果你有空的話，約翰·麥克哈奇森可能會把他的AO借給你去旅行。我只是想就幾項管道應急措施向約翰·麥克哈奇森諮詢一下。首先你提到了 MANTA 研究，顯然今年上半年你還會有 3 個 FINCH 研究。這份文件的提交是否有可能延後到2020年？或者，有沒有辦法先提交臨床數據，然後再將財務數據附加到文件中？其次，您是否有機會查看 NASH 聯合治療研究的中期數據，並有可能考慮在 48 週數據之前進行某些聯合治療的關鍵性試驗？

Yes, Geoff, starting with MANTA, great question. We have spent an inordinate amount of effort trying to enhance the enrollment in the MANTA study. It's too early to gauge the effectiveness of those modifications to inclusion criteria, et cetera. I think we'll provide an update in the future when we can add more clarity about the time lines. I will say we are having discussions internally and with regulators about different options, as one of which you outlined as well. And as you know, in various parts of the world, you can file and you can file updates at various different times of the review process. So each region and each area is different. So we're having all of these discussions and spending a lot of my effort and a lot of the team's effort on that as well. In terms of the Atlas, the second question in terms of the Atlas Phase IIb, 350-patient NASH combination study, yes, we will take a look at week 24. A week 24 look we're allowed to do in the statistical analysis plan. It's not biopsy driven; it's driven by MRE, FibroScan, lab test, MRI, PDFF. So we will be able to have a look. And if there's clear separation without biopsy, we can decide to move earlier to Phase III, if we're convinced that's the right thing to do.

是的，Geoff，從 MANTA 開始，問得好。我們投入了大量精力來提高 MANTA 研究的參與率。現在評估這些對納入標準等方面的修改的有效性還為時過早。我認為，未來當我們能夠更清晰地說明時間表時，我們會提供最新消息。我想說的是，我們正在內部以及與監管機構討論不同的方案，其中一種方案您也已經概述過了。如您所知，在世界各地，您可以在審查過程的不同階段提交申請和更新申請。所以每個地區、每個區域的情況都不一樣。所以，我們進行了所有這些討論，我和團隊都投入了大量的精力。關於 Atlas，關於 Atlas IIb 期 350 例 NASH 聯合治療研究的第二個問題，是的，我們將關注第 24 週。統計分析計劃允許我們進行第 24 週的分析。這不是由活檢結果決定的；而是由 MRE、FibroScan、實驗室檢查、MRI、PDFF 等結果決定的。這樣我們就能一探究竟了。如果無需活檢就能明確區分，如果我們確信這樣做是正確的，我們可以決定提前進入 III 期臨床試驗。

Our next question comes from Robyn Karnauskas with Citi.

下一個問題來自花旗銀行的 Robyn Karnauskas。

This is Greg Harrison on for Robyn. So in hep B, given the Arrowhead data we've seen recently, do you think that you need an S antigen component in your combos? Or are you satisfied with what you have internally?

這裡是格雷格·哈里森，他正在為羅賓做報道。所以，根據我們最近看到的 Arrowhead 數據，對於乙肝，你認為你的聯合療法需要 S 抗原成分嗎？還是你對自己的內在狀態感到滿意？

I don't think we're ever satisfied with what we have internally. And we have a number of internal programs that are looking at interfering at S in various different ways, either by direct mechanisms or through induction of HBV-specific immunity and we're also always looking for what we think is additionally valuable to what we're doing internally, externally as well. We are watching the siRNA field closely also and are aware of what Arrowhead's done. We look forward to seeing the data presented in full at AASLD.

我認為我們永遠不會對內部現狀感到滿意。我們有一些內部項目正在研究以各種不同的方式乾擾 S，無論是透過直接機制還是誘導 HBV 特異性免疫，我們也一直在尋找我們認為對我們內部和外部的工作有額外價值的東西。我們也密切關注著siRNA領域，並且了解Arrowhead公司所做的工作。我們期待在AASLD會議上看到完整的數據呈現。

Our next question comes from Umer Raffat with Evercore.

我們的下一個問題來自 Evercore 公司的 Umer Raffat。

John, wanted to extend my congratulations on all of your and Gilead's success over the years. My question was perhaps twofold. One, going forward for the new CEO, is there specific expectations that the board has set? May that be on specific M&A targets, dollar size, number of transactions, just wanted to get a flavor for the direction of the company and board's expectations. And then secondly on CAR T we heard your commentary on the variability in adoption and my question is Street has a 50% growth over the next 4 quarters for Yescarta franchise. And given how important a launch it is, my question is do you remain confident in that type of growth trajectory?

約翰，我想對你和吉利德公司多年來取得的所有成功表示祝賀。我的問題或許包含兩面。第一，對於新任執行長的未來發展，董事會是否有具體的期望？或許是關於具體的併購目標、金額規模、交易數量，我只是想了解公司的發展方向和董事會的期望。其次，在 CAR T 上，我們聽到了您對採用率差異的評論，我的問題是，Street 預測 Yescarta 特許經營權在未來 4 個季度將增長 50%。鑑於此次發布的重要性，我的問題是，您是否仍然對這種成長軌跡充滿信心？

So first let me start with the specific criteria for a new CEO. No, I -- that's not typically how things are done. There is -- there are conversations and looking at different strategies that a new CEO could bring to Gilead, but no, there are no specific targets or directions that were given by the board. So secondly the question about CAR T is a good one. So if you think about CAR T and you think about the shift in paradigm that has to occur in a treatment center to adopt it, it requires lots of collaboration across multiple departments, it requires novel ways of thinking about billing and treating patients. And it takes time for these centers to come up to speed. The centers that were early adopters of CAR T and are still the biggest users of Yescarta have a lot of experience and have kind of worked out the treatment and frankly, business paradigm of cellular therapy. And that's where we're seeing the majority of our success to date. The middle adopters and now the late adopters are the groups that are really trying to figure out how to make this work within their institution and how to make this business model work for their hospital in particular and that can take some time. So what we would expect is that as these centers start to treat, as they work out how to bill the commercial plans, as they figure out how to get reimbursement through -- for Medicare patients, this will grow over time, and of course we'll see some centers that have greater adoption and some that have less. So I do think that with the data that are emerging on CAR T, with the growing body of evidence that a high percentage of patients can have very durable responses, this is something that will grow to become of importance in all 60 centers that we are in. But it is going to take some time to get the growth rate that we need. I won't comment on any specifics, but I am very confident that as we get better at this, as the medical practice gets better, as we get better at managing some of the side effects around this, and then importantly, in the future, as we get a DRG code, this will grow into a very important business for Gilead and it will be very, very important for patients who have run out of options.

首先，讓我從新任CEO的具體標準開始說起。不，我——事情通常不是這樣處理的。確實有一些討論，也在探討新任執行長可能為吉利德帶來的不同策略，但是，董事會並沒有給出任何具體的目標或方向。其次，關於CAR-T的問題問得很好。因此，如果你考慮 CAR-T 療法，並考慮治療中心要採用這種療法必鬚髮生的範式轉變，就會發現它需要多個部門之間的大量合作，需要以全新的方式思考計費和治療患者。這些中心需要時間才能達到正常運作狀態。那些最早採用 CAR-T 療法並且仍然是 Yescarta 最大用戶的中心擁有豐富的經驗，並且已經摸索出了細胞療法的治療模式，坦白說，也摸索出了細胞療法的商業模式。而這正是我們迄今為止大部分成功的地方。中間採用者和現在的後期採用者群體，正在努力弄清楚如何在他們的機構內實施這項技術，以及如何使這種商業模式特別適用於他們的醫院，這可能需要一些時間。因此，我們預計，隨著這些中心開始提供治療，隨著他們弄清楚如何向商業保險計劃收費，隨著他們弄清楚如何獲得報銷——對於醫療保險患者來說，這種情況會隨著時間的推移而增長，當然，我們會看到一些中心的採用率更高，而一些中心的採用率較低。所以我認為，隨著 CAR-T 療法數據的不斷湧現，以及越來越多的證據表明很大一部分患者可以獲得非常持久的療效，這項療法在我們所在的 60 個中心都將變得越來越重要。但要達到我們所需的成長率，還需要一些時間。我不會評論任何具體細節，但我非常有信心，隨著我們在這方面做得越來越好，隨著醫療實踐的不斷改進，隨著我們更好地控制一些副作用，更重要的是，未來當我們獲得DRG代碼時，這將發展成為吉利德一項非常重要的業務，並且對於那些已經走投無路的患者來說，這將非常非常重要。

Our next question comes from Alethia Young with Cantor Fitzgerald.

下一個問題來自 Cantor Fitzgerald 的 Alethia Young。

Congrats on Biktarvy, and John, you certainly will be missed and we truly enjoyed seeing, observing your leadership over such a long tenure. I guess I have a question on HIV and generics in Europe. You said obviously you've seen some impact and there actually have been some countries where you haven't thought -- you thought you would see impact and didn't, so can you talk a little bit more about those certain dynamics there?

恭喜 Biktarvy，約翰，我們一定會想念你的，我們非常榮幸能夠見證你在如此漫長的任期內展現出的領導才能。我想問一個關於歐洲愛滋病毒和仿製藥的問題。您說顯然您已經看到了一些影響，但實際上也有一些國家您原本以為會看到影響，但結果卻沒有，那麼您能再多談談這些具體情況嗎？

Sure, Alethia. Congrats on your new role as well. Yes, we continue to see adoption of generics across Europe. I think what we're seeing is differentiation across the different countries relative to the timing and the uptake of generics. We talked about the uptake of Descovy, that continues to go really well and we think that's thwarting some of that uptake. Particularly in Italy and U.K., we're just not seeing the uptake of generics as quickly as we thought they would take hold. And that's something that we factored into our guidance to the tune of $100 million. I think even in 2019, we'll continue to see uptakes of generics, but with the launch of Biktarvy, et cetera, we think we'll be well competitively positioned and think all the benefits of Descovy will help us to continue to grow share in our ex U.S. markets.

當然可以，阿萊西亞。也恭喜你榮升新職。是的，我們看到仿製藥在歐洲各地持續應用。我認為我們看到的是不同國家在仿製藥上市時間和普及程度的差異。我們討論了 Descovy 的普及情況，它目前進展非常順利，我們認為這在一定程度上阻礙了它的普及。尤其是在義大利和英國，我們並沒有看到仿製藥像我們預期的那樣迅速普及。而這正是我們在業績預期中考慮的因素之一，金額高達 1 億美元。我認為即使到了 2019 年，仿製藥的銷量仍會繼續增長，但隨著 Biktarvy 等產品的上市，我們認為我們將擁有良好的競爭優勢，並認為 Descovy 的所有優勢將有助於我們繼續擴大在美國以外市場的份額。

Our next question comes from Phil Nadeau with Cowen.

下一個問題來自 Cowen 公司的 Phil Nadeau。

John, let me add my congratulations on all that you've accomplished and best of luck on your next act. My question is on the guidance. It looks like that even at the top end of the guidance, you're projecting a sequentially down quarter in Q4. Curious to get a little bit more information on what elements do you think are going to have a quarter-over-quarter decline? Is that HCV? Is that EU HIV? Any information you can give us would be appreciated.

約翰，請容許我向你表示祝賀，祝賀你所取得的所有成就，並祝你在接下來的工作中一切順利。我的問題與指導有關。即使按照預期上限來看，你們也預測第四季業績將環比下滑。很想了解一下，您認為哪些因素會較上季下降？那是丙型肝炎嗎？那是歐盟的愛滋病毒嗎？您提供的任何資訊都將不勝感激。

Sure, Phil. I won't go, again, we kind of gave a base of our guidance. First let me just say we're really very satisfied with how the year has gone and the ability to raise guidance at this point. Everything that we've talked about, from HIV being a growth franchise to HCV stabilizing, Yescarta continuing to have a nice slow and steady build. I mean I think overall, all our franchises are performing very well. There's a couple of dynamics. You mentioned a few. One, HCV, as we said, while stabilizing, we do continue to see declines in patient starts, as that's the primary driver. Recall we talked last quarter about a price freeze for the next 6 months, which if you think about a typical Q4, we sometimes see inventory build in Q4 in advance of that price increase. And not saying we won't have any inventory build, because some of that is just part of supply chain, but we do anticipate that there may be a little less. And as I mentioned, the other driver of our raise in guidance was Letairis and the LOE, which is here. We haven't seen any impact. That could happen, right. So we are providing a range of guidance, but we're very confident with our ability to meet the guidance and hope to overachieve it.

當然可以，菲爾。我不會再去了，我們已經給了一些指導原則。首先我想說的是，我們對今年的業績以及目前提高業績預期都非常滿意。我們討論過的所有事情，從 HIV 成為成長型業務到 HCV 趨於穩定，Yescarta 繼續保持著良好而緩慢的成長勢頭。我的意思是，我認為總體而言，我們所有加盟店的業績都非常好。這裡涉及幾個面向。你提到了一些。第一，正如我們所說，HCV雖然趨於穩定，但我們仍然看到患者數量下降，因為這是主要驅動因素。回想一下，我們上個季度討論過未來 6 個月的價格凍結，如果你想想典型的第四季度，我們有時會看到庫存提前在第四季度積累，以應對價格上漲。並不是說我們不會有任何庫存積壓，因為其中一部分只是供應鏈的一部分，但我們預計庫存量可能會略少一些。正如我之前提到的，我們提高業績預期的另一個原因是 Letairis 和 LOE，詳情如下。我們尚未看到任何影響。這有可能發生，對吧。因此，我們提供一系列指導，但我們對滿足這些指導非常有信心，並希望能夠超額完成目標。

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 guess, first to John, congrats again on a really great run. So I guess, my question is on Biktarvy, on the heels of another really impressive quarter for the product. I'm just curious if there was any meaningful contribution from inventory build or any other type of one-time item? Or is this really all just demand-driven?

首先，我要再次祝賀約翰，他跑得非常出色。所以我想問的是Biktarvy，因為產品剛剛經歷了一個非常令人印象深刻的季度。我只是好奇庫存累積或其他一次性物品是否做出了任何有意義的貢獻？或者這一切真的只是由需求驅動的？

Cory, great question. No, our sequential growth was all demand-driven. We didn't see really any change in inventory and as you're probably recalling last quarter, I talked about the fact that we were at a 50-50 payer mix between commercial and government. And there was the chance that, that would have shifted back to what we've traditionally seen: 45% commercial; 55% government. But we didn't see that. And these payer mix percentages do fluctuate quarter-to-quarter, really dependent on the buying patterns from government payers such as ADAP. So overall, a strong demand-driven quarter for Biktarvy. Again, just in HIV overall, no impact from inventory or payer mix.

科里，問得好。不，我們的持續成長完全是由需求驅動的。我們沒有看到庫存發生任何實際變化，而且你可能還記得上個季度我談過，我們的支付方組合是商業支付方和政府支付方各佔 50%。還有一種可能性是，這種情況會恢復到我們傳統上看到的比例：45% 商業；55% 政府。但我們並沒有看到這一點。而且這些支付方組合百分比確實會逐季度波動，這實際上取決於政府支付方（如 ADAP）的購買模式。整體而言，Biktarvy 本季需求強勁，整體表現良好。再次強調，就愛滋病毒感染者整體而言，庫存或支付方組合均無影響。

Our next question comes from Terence Flynn with Goldman Sachs.

下一個問題來自高盛的 Terence Flynn。

Maybe just a couple follow-ups on Biktarvy and the TAF portfolio. First can you just comment on European pricing dynamics for Biktarvy, now that you're a little bit further in and maybe help us think about that heading into 2019? And then can you guys disclose total TAF volume in Europe right now? I know you give us that for the U.S., but just wondering where it stands in Europe.

或許可以再跟進一下 Biktarvy 和 TAF 投資組合的情況。首先，您能否談談 Biktarvy 在歐洲的定價動態？既然您已經取得了一些進展，或許可以幫我們思考一下 2019 年的定價策略？那麼，你們能否公佈一下目前歐洲TAF的總交易量呢？我知道你們在美國有這樣的數據，但我只是想知道它在歐洲的情況如何。

Yes, so it's hard to talk about volume, because of generics. We do talk about TAF or Descovy base as a percentage of revenue and it's about 70% of revenues in U.S. Pricing really hasn't been a barrier. Keep in mind, we price -- our Descovy regimens are pretty much priced similar to Stribild, et cetera, Genvoya, Biktarvy, so it's really been good overall uptake. I think we'll always see competitiveness in European pricing, but that's something that we're used to. So it really fundamentally has been just the desire for more and more patients to want to move to Descovy-based regimens that has been driving our performance, offset by the adoption of generics.

是的，由於仿製藥的存在，很難談論銷量。我們確實會談到 TAF 或 Descovy 基礎收入佔收入的百分比，在美國，這個比例約為收入的 70%。定價其實並沒有成為障礙。請記住，我們的定價——我們的 Descovy 療法的價格與 Stribild、Genvoya、Biktarvy 等療法的價格非常相似，因此總體接受度非常好。我認為歐洲的定價競爭將一直存在，但我們已經習以為常了。因此，從根本上來說，推動我們業績成長的，正是越來越多的患者希望轉向基於 Descovy 的治療方案，而仿製藥的普及則抵消了這一增長。

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

下一個問題來自美國銀行美林證券的黃穎。

Congrats to John as well. So first one on Yescarta, I think, Robin, you mentioned that now you do have this new technology add-on payment. I was wondering how much that helps the adoption for Yescarta under that? And how much is this financial loss is actually stopping the centers from adopting Yescarta? And then secondly we noticed that you have exclusive status with Express Scripts for 2019, and Mavyret from AbbVie was excluded. Does that mean there's additional pricing concession or rebate provided by Gilead?

也祝賀約翰。首先是關於 Yescarta 的，Robin，我想你提到你們現在有了這項新的技術附加支付功能。我想知道這能對Yescarta的推廣有多大幫助？究竟是多大的經濟損失阻礙了各中心採用 Yescarta？其次，我們注意到您在 2019 年與 Express Scripts 擁有獨家經銷權，而 AbbVie 的 Mavyret 被排除在外。這是否意味著吉利德公司提供了額外的價格優惠或折扣？

So let me start with the prior question. I think, as always, as our case, we're always working and negotiating with payers, I won't -- I can't talk specifically to the details of a contract, but we're happy that we've reached the formulary ranking with Express Scripts and it's something that we talked all about, that we continue to be out there, competing in this marketplace. There is us and Mavyret, and we continue to do well. I think to your other question relative to Yescarta, yes, the NTAP as I said, it's a start. As we understand it, it's about 50% of reimbursement. Just to tell you what every hospital makes or doesn't make, that's very hard for me to comment on. That's very dependent on their relationship with the payers, et cetera. So I can't give you more details on that. I do think the NTAP is a start and we're working very, very diligently and hard to continue to show the value of this treatment and hopefully, eventually see a DRG specific for CAR T therapy.

那麼，就讓我先回答之前的問題吧。我認為，和以往一樣，我們一直在與付款方合作和談判，我不能具體談論合約的細節，但我們很高興能夠與 Express Scripts 達成處方集排名，這是我們一直討論的事情，我們將繼續在這個市場上競爭。我們和 Mavyret 兩家公司都發展良好。關於你提出的另一個與 Yescarta 相關的問題，是的，正如我所說，NTAP 是一個很好的開始。據我們了解，這大約是報銷金額的 50%。要告訴你每家醫院的收入狀況，我很難評論。這很大程度上取決於他們與付款方的關係等等。所以我無法提供更多細節。我認為 NTAP 是一個好的開始，我們正在非常努力地繼續證明這種療法的價值，並希望最終能看到專門針對 CAR T 療法的 DRG。

And our final question comes from Steven Seedhouse with Raymond James.

最後一個問題來自 Raymond James 的 Steven Seedhouse。

Just on NASH, understanding the hope is obviously that both STELLAR 3 and STELLAR 4 succeed, I'm curious if there's a viable filing strategy or path forward for either monotherapy or a combination therapy for selonsertib in basically a refined fibrosis subset of NASH patients, if 1 of those 2 Phase III trial hits the primary endpoint? Or have you designed the clinical program such that both Phase III trials need to work to move selonsertib forward?

僅就 NASH 而言，顯然大家都希望 STELLAR 3 和 STELLAR 4 都能成功，我很好奇，如果這兩項 III 期試驗中的一項達到了主要終點，那麼對於 NASH 患者中一個經過篩選的纖維化亞群，selonsertib 的單藥治療或聯合治療是否存在可行的申請策略或前進方向？或者，你們是否已經設計了臨床方案，使得兩項 III 期試驗都必須成功才能推進 selonsertib 的研發？

So it's a good question regarding the STELLAR programs and I think the answer to your question lies in the STELLAR programs, where our discussions with regulators were around both trials independently, but I think everybody understands that 1/3 of patients with F3 really have F4 and 1/3 of patients with F4 have F3. So if, for example, there was a situation where 1 trial was positive and 1 trial was negative, we would be able to look at different subgroups of patients, but that would be a completely unscripted discussion that would just depend on what the data looked like at that time.

所以，關於 STELLAR 項目，這是一個很好的問題。我認為答案就在 STELLAR 項目。我們與監管機構的討論是圍繞這兩項試驗獨立進行的，但我認為大家都明白，1/3 的 F3 患者實際上是 F4，1/3 的 F4 患者實際上是 F3。例如，如果出現一種情況，即 1 項試驗結果為陽性，1 項試驗結果為陰性，我們可以研究不同的患者亞組，但這將是一個完全沒有預先設定的討論，完全取決於當時的數據情況。

Thank you for participating in today's question-and-answer session. I would now like to turn the call back over to Sung Lee for any closing remarks.

感謝您參加今天的問答環節。現在我想把電話轉回給李成，請他作總結發言。

Thank you, Sherry, 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.

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

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

女士們、先生們，感謝各位參加今天的會議。節目到此結束。大家可以斷開連接，祝你們有美好的一天。