吉利德科學 (GILD) 2017 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Third Quarter 2017 Earnings Conference Call. My name is Karen, and I will be your conference operator today. (Operator Instructions)

女士們、先生們，感謝各位的耐心等待，歡迎參加吉利德科學公司2017年第三季財報電話會議。我叫凱倫，今天我將擔任你們的會議接線生。（操作說明）

And as a reminder, this conference call is being recorded.

再次提醒大家，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, Karen, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the third quarter 2017. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

謝謝你，凱倫，大家下午好。今天股市收盤後不久，我們發布了 2017 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 John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; and Jim Meyers, Executive Vice President, Commercial Operations. Also in the room with us for the Q&A session are Kevin Young, Chief Operating Officer; Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer; and Alessandro Riva, Executive Vice President, Oncology Therapeutics.

今天電話會議的發言人有：總裁兼執行長約翰·米利根；執行副總裁兼財務長羅賓·華盛頓；以及執行副總裁兼商業營運主管吉姆·邁耶斯。與我們一同參加問答環節的還有營運長 Kevin Young；研發執行副總裁兼首席科學官 Norbert Bischofberger；以及腫瘤治療執行副總裁 Alessandro Riva。

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 the latest SEC disclosure documents and recent press releases. In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call.

在我們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可以在最新的美國證券交易委員會披露文件和最近的新聞稿中找到。此外，吉利德不承擔更新本次電話會議中任何前瞻性聲明的義務。

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

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

I will now turn the call over to John.

現在我將把通話轉給約翰。

Thank you, Sung.

謝謝你，宋。

It's been an incredibly busy and exciting few months here at Gilead. In late August, we announced the planned acquisition of Kite. About 5 weeks later, we completed the transaction, and Kite and Gilead began operating as one company. Only 15 days after close, we received FDA approval for Yescarta, the first CAR T therapy approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

過去幾個月，吉利德公司一直都非常忙碌，也令人興奮。8 月下旬，我們宣布了收購 Kite 的計劃。大約 5 週後，我們完成了交易，Kite 和 Gilead 開始作為一家公司運作。交易完成後僅 15 天，我們就獲得了 FDA 對 Yescarta 的批准，這是首個獲準用於治療接受過 2 線或以上全身治療後復發或難治性大 B 細胞淋巴瘤成年患者的 CAR-T 療法。

Kite and Gilead employees are now working together to prepare for the first patients to enter Yescarta treatment. Consistent with the requirements of the Yescarta REMS program, the Kite team has begun collaborating with academic cancer centers to finalize training and complete certification. The first 13 centers are expected to be approved in about 2 weeks, and each center will be able to accept patients for Yescarta treatment as soon as the approval is received. As to those of you who followed Kite know, this will be a controlled launch to ensure patient safety. CAR T therapy is complicated and can sometimes be associated with severe side effects. Even though the medical community has been learning over the course of the clinical trials how to more effectively manage adverse events, proper training and preparation for health care teams on oncology and transplantation centers is essential to help ensure the best outcome for CAR T patients.

Kite 和 Gilead 的員工現在正在共同努力，為首批接受 Yescarta 治療的患者做好準備。根據 Yescarta REMS 計劃的要求，Kite 團隊已開始與學術癌症中心合作，以完成培訓和認證。預計首批 13 個中心將在大約 2 週內獲得批准，每個中心一旦獲得批准即可開始接收接受 Yescarta 治療的患者。有關注Kite的人都知道，這將是一次受控發射，以確保患者安全。CAR-T療法較為複雜，有時伴隨嚴重的副作用。儘管醫學界在臨床試驗過程中不斷學習如何更有效地管理不良事件，但對腫瘤科和移植中心的醫療團隊進行適當的培訓和準備對於確保 CAR-T 患者獲得最佳療效至關重要。

Yescarta is a transformational therapy for patients who have run out of options and who had waiting for new treatment that may help them in their fight against cancer. And we greatly appreciate the partnership and leadership of FDA to improve Yescarta ahead of the PDUFA date, helping ensure it reaches patients as quickly as possible. Historically, only 7% of patients with refractory diffuse large B-cell lymphoma achieve a complete response. And patients live, on average, just 6 months when treated with the current standard of care. Yescarta serves a population who have largely run out of options, and it is essential to expedite access for those patients.

Yescarta 是一種變革性的療法，適用於那些已經沒有其他治療選擇，並且一直在等待可能幫助他們對抗癌症的新療法的患​​者。我們非常感謝 FDA 的合作與領導，在 PDUFA 日期之前改進 Yescarta，幫助確保它能盡快惠及病患。從歷史上看，只有 7% 的難治性瀰漫性大 B 細胞淋巴瘤患者能夠獲得完全緩解。而接受目前標準治療的患者平均壽命只有 6 個月。Yescarta 服務於那些基本上已經沒有其他選擇的人群，因此加快這些患者的就醫速度至關重要。

The approval of Yescarta is supported by data from the ZUMA-1 pivotal trial. In this study, 72% of patients treated with a single infusion of Yescarta responded to therapy, including 51% of patients who had a complete response, and the median duration of response had not yet been reached after median follow-up of 7.9 months. Data from patients enrolled on the ZUMA-1 study, who had a minimum of 12 months of follow-up, will be presented at the American Society of Hematology meeting in December. Also at ASH, results will be presented from ZUMA-3, a Phase I/II study in adult patients with refractory or relapsed acute lymphoblastic leukemia. Once a drug is approved, the work continues, of course. There are a number of studies of Yescarta in other lymphomas and earlier lines of therapy that are planned or ongoing. Additionally, clinical studies of CD19 CAR Ts, or modified T cell receptor T cells, are planned or ongoing in other B-cell malignancies, leukemias or solid tumors. Beyond these studies, Gilead and Kite will continue to invest in research and development in order to bring forward future generations of CAR Ts and TCRs, with the goal of increasing short- and long-term complete response rates and improving safety.

Yescarta 的核准是基於 ZUMA-1 關鍵性試驗的數據。在這項研究中，接受單次 Yescarta 輸注治療的患者中有 72% 對治療有反應，其中 51% 的患者有完全緩解，中位追蹤時間為 7.9 個月，但尚未達到緩解持續時間的中位數。ZUMA-1 研究的受試者數據（至少追蹤 12 個月）將於 12 月在美國血液學會會議上發表。此外，ASH 也將公佈 ZUMA-3 的結果，這是一項針對難治性或復發性急性淋巴細胞白血病成年患者的 I/II 期研究。當然，藥物獲準後，後續工作仍會持續。目前還有許多關於 Yescarta 在其他淋巴瘤和早期治療方案中的研究正在計劃或進行中。此外，針對其他 B 細胞惡性腫瘤、白血病或實體瘤，CD19 CAR T 細胞（或稱為修飾的 T 細胞受體 T 細胞）的臨床研究正在規劃或進行中。除了這些研究之外，吉利德和凱特將繼續投資於研發，以推出下一代 CAR-T 和 TCR，目標是提高短期和長期完全緩解率並提高安全性。

Gilead, along with our new employees at Kite, is proud to be part of the advancement of an innovative cellular therapy that is bringing hope and benefit to patients.

吉利德及其在 Kite 的新員工們，很榮幸能參與這項創新細胞療法的研發進程中，為患者帶來希望和益處。

I would like to take a moment to commend and congratulate Arie Belldegrun and the Kite team for what they have accomplished. CAR T is among the most significant breakthroughs in cancer treatment in decades, and I look forward to sharing more about our progress in the coming months.

我想藉此機會表揚並祝賀 Arie Belldegrun 和 Kite 團隊所取得的成就。CAR-T療法是近幾十年來癌症治療領域最重大的突破之一，我期待在接下來的幾個月與大家分享我們取得的更多進展。

Moving to other therapeutic areas. We continue to make significant progress with our liver disease pipeline. Last week, researchers presented more than 40 abstracts featuring a Gilead product or investigational compound at The Liver Meeting in Washington, D.C., including data on HCV, HPV or NASH. During the late-breaking abstract session, important Phase II data results for GS-0976, our investigational ACC inhibitor, were presented in patients with NASH. The data demonstrated that GS-0976 led to significant reductions in measures of liver fat and certain biomarkers of liver fibrosis compared to placebo. This is the first randomized, placebo-controlled Phase II study of an ACC inhibitor NASH. The study suggests that GS-0976 has a potential to play an important role in treating patients with the disease.

轉向其他治療領域。我們在肝病研發管線方面持續取得重大進展。上週，研究人員在華盛頓特區舉行的肝臟會議上發表了 40 多篇摘要，其中介紹了吉利德的產品或研究性化合物，包括有關 HCV、HPV 或 NASH 的數據。在最新摘要會議上，我們公佈了在 NASH 患者中，我們正在研究的 ACC 抑制劑 GS-0976 的重要 II 期數據結果。數據顯示，與安慰劑相比，GS-0976 可顯著降低肝臟脂肪含量和某些肝纖維化生物標記。這是第一項針對 ACC 抑制劑 NASH 的隨機、安慰劑對照 II 期研究。該研究表明，GS-0976 有可能在治療該疾病患者方面發揮重要作用。

We are also conducting Phase II combination studies of GS-0976 with Gilead's ASK1 inhibitor, selonsertib, and the selective nonsteroidal FXR agonist, GS-9674, in patients with NASH. Depending on the outcomes of these trials, we may initiate larger Phase II combination studies next year.

我們目前也正在對 NASH 患者進行 GS-0976 與吉利德的 ASK1 抑制劑 selonsertib 和選擇性非類固醇 FXR 激動劑 GS-9674 的 II 期聯合研究。根據這些試驗的結果，我們明年可能會啟動更大規模的 II 期聯合用藥研究。

Also, at The Liver Meeting, researchers presented new data that demonstrated high curates in difficult-to-treat patients with Gilead's hepatitis C treatment. And improved long-term bone and renal safety among patients with hepatitis B were treated with Vemlidy, adding to the body of evidence supporting the safety and efficacy of Gilead's viral hepatitis therapies in diverse patient populations.

此外，在肝臟會議上，研究人員展示了新的數據，顯示吉利德的丙型肝炎治療對難治性患者俱有很高的治癒率。Vemlidy 治療乙型肝炎患者的長期骨骼和腎臟安全性得到改善，這進一步證實了吉利德病毒性肝炎療法在不同患者群體中的安全性和有效性。

In September, we announced that SOVALDI received approval in China, the first approval for our product that Gilead will launch directly in that country. Approximately 10 million people are estimated to be living with HCV in China, highlighting a tremendous need. The regulatory filings for Harvoni and Epclusa are planned in the near future. We have begun hiring a team to support the launch of SOVALDI in future products, with a focus on medical education and market access. Gilead's products serve important unmet needs in China. And in addition to the HCV products, we have filed the MAA for Vemlidy for HBV, and filings are planned for a number of our HIV products.

9 月，我們宣布 SOVALDI 在中國獲得批准，這是吉利德公司將在中國直接推出的首個核准產品。據估計，中國約有1000萬人感染丙型肝炎病毒，凸顯了巨大的需求。Harvoni 和 Epclusa 的監管文件計劃在近期提交。我們已開始招募團隊，以支持 SOVALDI 在未來產品的推出，重點是醫學教育和市場准入。吉利德的產品滿足了中國重要的未被滿足的需求。除了 HCV 產品外，我們還提交了 Vemlidy（用於治療 HBV）的上市許可申請，​​並計劃提交多款 HIV 產品的上市許可申請。

As you will hear from Jim in a few minutes, our TAF-based regimens are performing extremely well. In August, we announced that bictegravir FTC/TAF, also known as B/F/TAF, our investigational fixed-dose combination of the integrase strand transfer inhibitor bictegravir, and the Descovy backbone was accepted by FDA for priority review with a PDUFA date of February 12, 2018. Review is also underway in Europe, with regulatory action expected toward the middle of next year. Data from 2 Phase III studies of B/F/TAF demonstrating noninferiority to dolutegravir-based triple-therapy regimens were presented at the International AIDS Society conference in Paris in July.

正如吉姆幾分鐘後會告訴你的那樣，我們基於 TAF 的治療方案效果非常好。8 月，我們宣布，我們正在研究的固定劑量組合藥物比克替拉韋 FTC/TAF（也稱為 B/F/TAF）——整合酶鏈轉移抑製劑比克替拉韋和 Descovy 骨架——已被 FDA 接受優先審查，PDUFA 日期為 2018 年 2 月 12 日。歐洲也在進行審查，預計明年年中採取監管行動。7 月在巴黎舉行的國際愛滋病協會會議上公佈了 2 項 B/F/TAF III 期研究的數據，證明其療效不劣於基於多替拉韋的三聯療法。

Earlier this month, we presented Phase III data on B/F/TAF, demonstrating noninferiority when switching from a boosted protease inhibitor-based regimen. These data suggest that B/F/TAF may be appropriate for a broad range of people living with HIV.

本月初，我們公佈了 B/F/TAF 的 III 期數據，證明從增強型蛋白酶抑制劑方案轉換而來時，其療效不劣於其他方案。這些數據表明，B/F/TAF 可能適用於廣泛的 HIV 感染者。

In conclusion, we are confident in the underlying strength of Gilead's business, driven by the successful execution of key product launches and advancement of various programs in HIV, liver disease and now cellular therapy, all of which positions us well for long-term success.

總而言之，我們對吉利德業務的內在實力充滿信心，這得益於關鍵產品的成功上市以及在 HIV、肝病和現在的細胞療法等領域各項項目的推進，所有這些都為我們取得長期成功奠定了良好的基礎。

I will now turn the call over to Robin, who will review our financial performance for the quarter.

現在我將把電話交給羅賓，她將回顧我們本季的財務表現。

Thanks, John, and good afternoon, everyone. We are pleased to share our financial results for the third quarter of 2017.

謝謝你，約翰，大家下午好。我們很高興與大家分享2017年第三季的財務表現。

Total revenue for the third quarter were $6.5 billion, with non-GAAP diluted earnings per share of $2.27. This compares to revenues of $7.5 billion and non-GAAP earnings per share of $2.75 for the same period last year. Product sales for the third quarter were $6.4 billion, down 14% year-over-year and down 9% sequentially. As expected, we continue to see the impact of lower HCV patient starts and the beginning effects of increased competition on our HCV franchise in the third quarter. The declines in HCV revenue were partially offset by the strong uptake of our HIV portfolio, resulting in increased non-HCV revenues.

第三季總營收為 65 億美元，非 GAAP 稀釋後每股收益為 2.27 美元。相比之下，去年同期營收為 75 億美元，非 GAAP 每股收益為 2.75 美元。第三季產品銷售額為 64 億美元，年減 14%，季減 9%。正如預期的那樣，我們在第三季度繼續看到丙型肝炎患者數量減少以及競爭加劇對我們的丙型肝炎業務的影響。HCV 收入的下降部分被 HIV 產品組合的強勁需求所抵消，從而導致非 HCV 收入增加。

Turning to the U.S. Product sales for the third quarter were $4.5 billion, down 10% year-over-year and 9% sequentially. HCV product sales were $1.4 billion, down 31% year-over-year and 26% sequentially. The declines were primarily driven by lower patient starts and the effect of increased competition. Non-HCV product sales were $3.1 billion, up 4% year-over-year and 2% sequentially, driven primarily by higher demand for our TAF-based regimens. As a reminder, our prior year third quarter revenues benefited from a favorable adjustment of $332 million to rebate reserves, primarily related to our TDF-based regimens. Excluding this adjustment, our non-HCV revenues grew 16% year-over-year.

再來看美國市場。第三季產品銷售額為 45 億美元，年減 10%，季減 9%。HCV產品銷售額為14億美元，年減31%，季減26%。下降的主要原因是患者數量減少和競爭加劇。非 HCV 產品銷售額為 31 億美元，年增 4%，環比成長 2%，主要得益於市場對我們基於 TAF 的治療方案的需求增加。提醒一下，我們上年第三季的收入受益於回扣準備金 3.32 億美元的有利調整，這主要與我們基於 TDF 的治療方案有關。剔除此項調整後，我們的非HCV營收年增16%。

Turning to Europe. Product sales for the third quarter were $1.2 billion, down 15% year-over-year and 14% sequentially. The year-over-year decline was primarily due to competitive dynamics in HCV and the loss of exclusivity for Viread and Truvada, as was expected. The sequential decline was primarily due to the recognition of deferred revenue in the second quarter related to an HCV contract as well as lower total HCV market patient starts.

轉向歐洲。第三季產品銷售額為 12 億美元，年減 15%，季減 14%。同比下降的主要原因是 HCV 領域的競爭動態以及 Viread 和 Truvada 失去獨家銷售權，正如預期的那樣。環比下降主要是由於第二季度確認了與 HCV 合約相關的遞延收入，以及 HCV 市場患者總數減少。

Now turning to expenses. Non-GAAP R&D expenses were $745 million for the third quarter, down 24% compared to the same period last year, due primarily to the 2016 impact of a $200 million milestone expense associated with Nimbus. Non-GAAP SG&A expenses for the third quarter were $806 million compared to $780 million in the prior year.

現在來說說費用。第三季非GAAP研發費用為7.45億美元，比去年同期下降24%，這主要是由於2016年與Nimbus相關的2億美元里程碑支出的影響。第三季非GAAP銷售、一般及行政費用為8.06億美元，去年同期為7.8億美元。

Moving to the balance sheet. During the third quarter, we generated cash flow from operations of $2.7 billion and ended the quarter with $41.4 billion in cash and investments, inclusive of $3 billion in cash raised for the Kite acquisition via a debt issuance of senior unsecured notes. In October, we raised an additional $6 billion in term loans to fund a portion of the acquisition. We paid cash dividends of $682 million and repurchased 2 million shares of stock for $153 million in the third quarter. Our capital allocation strategy remains unchanged, and we will continue to prioritize the use of capital for investing in the long-term growth of our business.

接下來查看資產負債表。第三季度，我們透過經營活動產生了 27 億美元的現金流，季度末現金和投資總額為 414 億美元，其中包括透過發行優先無擔保票據為收購 Kite 籌集的 30 億美元現金。10 月份，我們又籌集了 60 億美元的定期貸款，用於為部分收購提供資金。第三季度，我們支付了 6.82 億美元的現金股息，並以 1.53 億美元的價格回購了 200 萬股股票。我們的資本配置策略保持不變，我們將繼續優先將資本用於投資業務的長期成長。

Finally, I would like to update our full year 2017 guidance provided to you on July 26 and summarized on Slide 21 in the earnings results presentation available on our corporate website.

最後，我想更新我們在 7 月 26 日向您提供的 2017 年全年業績指引，該指引已總結在我們公司網站上提供的盈利結果演示文稿的第 21 頁。

We are increasing the lower end of our previous range of net product sales guidance. We now expect net product sales to be between $24.5 billion to $25.5 billion. Non-HCV net product sales are expected to be in the range of $16 billion to $16.5 billion. HCV net product sales are expected to be in the range of $8.5 billion to $9 billion. We are decreasing the range for product gross margin to 86% to 87%. R&D expense is expected to be in the range of $3.4 billion to -- I'm sorry, $3.3 billion to $3.4 billion. SG&A expense is expected to be in the range of $3.3 billion to $3.4 billion. We are decreasing the range for the effective tax rate to 25% to 27%. This guidance is subject to a number of uncertainties, which are highlighted on Slide 21 in the earnings results presentation, including the accuracy of our estimates for HCV patient starts for the remainder of 2017 and lower-than-expected market share and greater price erosion in HIV as the result of the introduction of generic versions of TDF and the fixed-dose combination of FTC/TDF outside the U.S.

我們將提高先前淨產品銷售額預期範圍的下限。我們現在預計淨產品銷售額將在 245 億美元至 255 億美元之間。非丙型肝炎病毒（HCV）產品的淨銷售額預計在 160 億美元至 165 億美元之間。預計HCV淨產品銷售額將在85億美元至90億美元之間。我們將產品毛利率範圍下調至 86% 至 87%。研發費用預計在 34 億美元到——抱歉，是 33 億到 34 億美元之間。預計銷售、一般及行政費用將在 33 億至 34 億美元之間。我們將實際稅率範圍降低至 25% 至 27%。該指導意見受到諸多不確定因素的影響，這些不確定因素在盈利結果演示文稿的第 21 頁中重點列出，包括我們對 2017 年剩餘時間 HCV 患者開始治療的估計的準確性，以及由於 TDF 的仿製藥版本和 FTC/TDF 固定劑量組合在美國以外地區推出，導致 HIV 市場份額低於預期和價格進一步下降。

I will now turn the call over to Jim to discuss Gilead's commercial performance during the quarter.

現在我將把電話交給吉姆，讓他討論吉利德公司本季的商業表現。

All right. Well. Thank you, Robin, and good afternoon, everyone. I'm pleased to provide an update on our commercial performance for the third quarter, starting with HIV.

好的。出色地。謝謝你，羅賓，大家下午好。我很高興向大家報告我們第三季的商業業績，首先是愛滋病防治方面的情況。

In the U.S., our HIV and HBV franchise delivered another very strong quarter with revenues of $2.7 billion. TAF-based regimens now account for 56% of Gilead's total HIV prescription volume, up from 39% as we entered 2017. This rapid migration to TAF-based regimens reflects widespread physician acceptance of the Descovy backbone. Genvoya has been the most prescribed therapy across all categories, treatment-naïve, switch and total treated patients, since the third quarter of 2016. In addition, Descovy is on track to surpass both Atripla and Truvada to become the second most successful HIV product launch in U.S. history, behind only Genvoya.

在美國，我們的 HIV 和 HBV 業務又取得了非常強勁的季度業績，營收達 27 億美元。目前，基於 TAF 的治療方案佔吉利德 HIV 處方總量的 56%，高於 2017 年初的 39%。這種向基於 TAF 的治療方案的快速轉變反映了醫生們對 Descovy 基礎方案的廣泛接受。自 2016 年第三季以來，Genvoya 一直是所有類別（包括初治患者、轉換治療患者和所有接受過治療的患者）中處方量最高的療法。此外，Descovy可望超越Atripla和Truvada，成為美國歷史上第二成功的HIV產品上市，僅次於Genvoya。

We continue to see strong uptake of Truvada for PrEP. As we exited the third quarter, there were approximately 145,000 people in the U.S. taking Truvada for this indication, representing a fivefold increase since January 2015. Even with this accelerated growth, however, the CDC estimates there are still approximately 40,000 people infected each year. We have seen the impact of the use of Truvada for PrEP, along with other prevention efforts, on reducing new infections in certain communities in the U.S. And in hopes of building on this success in other regions, Gilead launched 2 new targeted media campaigns during the quarter aimed at educating people in at-risk populations, who currently have low awareness of HIV prevention and PrEP.

我們持續看到 Truvada 在 PrEP 領域得到廣泛應用。第三季結束時，美國約有 14.5 萬人服用 Truvada 治療該適應症，比 2015 年 1 月增加了五倍。即使成長速度加快，美國疾病管制與預防中心估計，每年仍有約 4 萬人感染。我們已經看到，在美國某些社區，使用 Truvada 進行 PrEP 以及其他預防措施，對減少新感染病例產生了影響。為了在其他地區延續這一成功，吉利德在本季度推出了兩項新的有針對性的媒體宣傳活動，旨在教育目前對 HIV 預防和 PrEP 認識較低的高風險族群。

Turning to Europe. Total HIV and HBV revenues were $716 million in the third quarter, down 2% year-over-year and down 2% sequentially. The quarter-on-quarter decrease was driven by the entries of generic TDF and TDF/FTC. Like in the U.S., strong uptake of our TAF-based regimens continues throughout Europe. Genvoya is the most prescribed therapy for both treatment-naïve and switch patients across the top 5 European markets. Physician and patient preference for TAF-based regimens remains strong, resulting in a 25% sequential quarterly revenue growth for the TAF portfolio. In early launch markets, like Germany, TAF-based regimens already account for more than 75% of Gilead's total HIV prescription volume. In France, Europe's largest HIV market, twice as many patients are switching to Genvoya as to any other regimen. And finally, in Italy, the uptake of both Descovy and Genvoya over the first 4 months of launch exceeded that of any prior HIV launch in the country.

轉向歐洲。第三季 HIV 和 HBV 總收入為 7.16 億美元，年減 2%，較上季下降 2%。季度環比下降是由仿製藥 TDF 和 TDF/FTC 的上市推動的。與美國一樣，我們基於 TAF 的治療方案在整個歐洲也持續受到廣泛認可。在歐洲前五大市場中，Genvoya 是初治患者和轉診患者最常使用的治療藥物。醫生和患者對基於 TAF 的治療方案的偏好仍然強烈，使得 TAF 產品組合的季度收入環比增長了 25%。在德國等早期上市市場，基於 TAF 的治療方案已佔吉利德 HIV 處方總量的 75% 以上。在歐洲最大的 HIV 市場法國，改用 Genvoya 的患者人數是改用其他任何療法的兩倍。最後，在義大利，Descovy 和 Genvoya 在上市後的前 4 個月的銷售量超過了該國以往任何 HIV 藥物的上市銷售量。

Turning to hep C. Total HCV revenues in the U.S. were $1.4 billion in the third quarter, down 31% year-over-year and down 26% sequentially. The quarter-on-quarter decrease was driven by declining HCV patient starts and the impact of increased competition. 39,000 patients began treatment on a Gilead regimen during the quarter, down 9% from the prior quarter, continuing the gradual decline in HCV patient starts that we've seen since the beginning of 2017. In July, we launched Vosevi, the first single-tablet regimen approved for the retreatment of adults with chronic HCV, fulfilling the unmet need for an effective regimen for patients who could not be cured with other therapies. For this small group of patients, Vosevi provides an important, new treatment option.

再來看丙肝。第三季美國C肝總營收為 14 億美元，年減 31%，季減 26%。季度環比下降的原因是 HCV 患者數量減少以及競爭加劇的影響。本季有 39,000 名患者開始接受吉利德療法治療，比上一季下降了 9%，延續了自 2017 年初以來 HCV 患者開始接受治療人數逐漸下降的趨勢。7 月，我們推出了 Vosevi，這是第一個獲準用於治療慢性丙型肝炎成人患者的單片復治方案，滿足了其他療法無法治癒的患者對有效治療方案的未滿足需求。對於這小部分患者而言，Vosevi 提供了一個重要的全新治療選擇。

Turning to Europe. We continue to see strong uptake of Epclusa, which is now the leading HCV regimen across the major European markets. We are also pleased to report that the European Commission granted marketing authorization for Vosevi in July, with reimbursement already achieved in Germany. And reimbursement is on track in other countries as payers acknowledge the unmet medical need. Overall, Gilead HCV patient starts in Europe were approximately 21,000 for the quarter.

轉向歐洲。我們持續看到 Epclusa 的強勁需求，它現在是歐洲主要市場領先的 HCV 治療方案。我們也很高興地報告，歐盟委員會於 7 月授予 Vosevi 上市許可，德國已實現報銷。其他國家的報銷工作也在按計劃進行，因為支付方已經意識到尚未滿足的醫療需求。該季度吉利德在歐洲的丙型肝炎患者總數約為 21,000 例。

Over the course of 2017, we observed lower patient starts in some of our early launch markets, partially offset by the impact of broader patient access in countries like Italy and France. And earlier this month, Spain and Switzerland granted access -- expanded access by removing fibrosis score restrictions.

在 2017 年，我們觀察到一些早期上市市場的患者數量有所下降，但義大利和法國等國家更廣泛的患者准入帶來的影響部分抵消了這一下降。本月初，西班牙和瑞士也批准了該藥物的使用——透過取消纖維化評分限制擴大了使用範圍。

Before moving away from HCV, I wanted to say a few words about the impact of new competition. As we have noted in the past, revenues in the HCV market are driven by 4 variables: patient starts, net pricing, market share and treatment duration. While patient starts have exceeded our expectations in 2017, the arrival of new competition has further eroded Gilead's market share and net pricing, which is now similar across genotypes. Some of those changes can be seen in our third quarter results, but the impact on pricing and market share will be more fully reflected beginning in the fourth quarter. Importantly, we have worked with payers to ensure that physician and patient access to Harvoni and Epclusa in 2018 will remain similar to what we saw in 2017. We believe that Gilead has the most comprehensive offering of treatments for patients with all types of HCV, importantly, backed by real-world cure rates comparable to clinical trial results.

在結束關於丙型肝炎病毒（HCV）的討論之前，我想談談新競爭的影響。正如我們過去所指出的，HCV 市場的收入受 4 個變數驅動：患者數量、淨定價、市場份額和治療持續時間。儘管 2017 年的患者開藥量超出了我們的預期，但新競爭對手的出現進一步削弱了吉利德的市場份額和淨定價，目前不同基因型的淨定價都比較接近。其中一些變化已在我們的第三季業績中有所體現，但對定價和市場份額的影響將從第四季度開始更充分地反映出來。重要的是，我們與支付方合作，確保醫生和患者在 2018 年獲得 Harvoni 和 Epclusa 的機會與 2017 年的情況類似。我們相信，吉利德為所有類型的C型肝炎患者提供了最全面的治療方案，更重要的是，其真實世界的治癒率與臨床試驗結果相當。

I'd like to close on the topic John began with, and that is last week's U.S. approval of Yescarta, which came a full 6 weeks ahead of the PDUFA date. Upon approval, we immediately began work to certify 16 leading cancer centers in 13 states to administer Yescarta. Given the exciting promise of CAR T therapy and patient need, our new colleagues are actively working to train more than 20 additional institutions with an eventual target of 70 to 90 centers across the U.S. As we embark on this revolutionary new approach to treating cancer, our colleagues at Kite are working extensively with payers and institutions to educate them on CAR T and Yescarta as well as collaborating with other key stakeholders to ensure understanding of the therapy's value and how to navigate the implementation and reimbursement processes.

最後，我想以約翰開始談論的話題作結，那就是上周美國批准 Yescarta，這比 PDUFA 日期提前了整整 6 週。獲得批准後，我們立即開始工作，認證 13 個州的 16 家領先癌症中心，使其能夠使用 Yescarta。鑑於 CAR-T 療法的令人振奮的前景和患者的需求，我們的新同事正積極努力培訓 20 多家機構，最終目標是在美國各地建立 70 至 90 個中心。在我們開啟這項革命性的癌症治療方法之際，Kite 的同事們正與支付方和醫療機構廣泛合作，向他們普及 CAR-T 療法和 Yescarta 的相關知識，並與其他關鍵利益相關者合作，以確保他們了解該療法的價值以及如何應對實施和報銷流程。

In keeping with our long-standing commitment to help make Gilead therapies accessible to patients in need, we are pleased to have Kite Konnect in place. This is a program developed by the Kite team that is customized to meet the unique needs of seriously-ill cancer patients. We look forward to updating you on the progress with Yescarta launch in the coming months.

為了履行我們長期以來幫助有需要的患者獲得吉利德療法的承諾，我們很高興Kite Konnect已經到位。這是由 Kite 團隊開發的程序，旨在滿足重症癌症患者的獨特需求。我們期待在接下來的幾個月向您報告 Yescarta 上線的進展。

In closing, I would like to take this opportunity to thank our employees for their commitment and dedication; for the Gilead employees, who continue to work hard to ensure patients have access to our life-saving medications; and for our new colleagues at Kite, who have been able to bring a breakthrough cancer treatment to patients with no other options.

最後，我想藉此機會感謝我們員工的付出和奉獻；感謝吉利德的員工，他們繼續努力工作，確保患者能夠獲得我們拯救生命的藥物；也感謝我們在Kite的新同事，他們為別無選擇的患者帶來了突破性的癌症治療。

I would now like to open the call for your questions. Operator?

現在我來接受大家的提問。操作員？

(Operator Instructions) Our first question comes from the line of 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 Geoff Meacham。

Just to follow on some of the recent comments in your prepared remarks on hep C. You guys have had some success last quarter and recently growing new starts. What's been this trend of late, especially now with the new product in the market from AbbVie? And I know you don't want to go into too much detail, but maybe speak generally to the length of commercial and public contracts, just thinking of the dynamics looking into next year and beyond.

針對您之前在準備好的演講稿中提到的一些問題，我想補充一點。你們上個季度取得了一些成功，最近也新增了一些病例。最近的這種趨勢是怎麼回事？特別是現在艾伯維公司推出了新產品？我知道您不想談得太詳細，但或許可以大致談談商業和公共合約的期限，想想明年及以後的發展動態。

Sure. I think there were a couple of questions in here. Maybe I'll deal with the contracts, which you mentioned. So what happened really is what typically is a 12-month contractual cycle that we're used to really became a 15-month contractual cycle, just largely based upon the timing of the launch of the new competition. So everything that we're working through right now in terms of finalizing the contractual process are contracts that will go through the balance of 2018.

當然。我覺得這裡面應該有幾個問題。或許我會處理你提到的那些合約。因此，原本我們習以為常的 12 個月合約週期，實際上變成了 15 個月的合約週期，這主要是由於新競爭的推出時間造成的。因此，我們目前正在處理的合約流程的最終確定工作，都是關於那些將在 2018 年剩餘時間內生效的合約。

Hey, Geoff, it's Kevin Young here. Let me add a little bit on the starts. The starts overall were down for the total HCV market, down 51,000 for this quarter, third quarter, versus 53,000. And there was also some change, as you would expect, because it's a new entrant in our market share. There was a tiny bit of pricing effect. But as Jim pointed out, that pricing and share effect will have a bigger impact in the fourth quarter and then rolling into 2018. I have to say, I think, we're still in a really strong position, as Jim pointed out, for 2018. We have really preserved the availability in our commercial payers and Part D for 2018 to use our options for hepatitis C. So that's what we were really asked to do by our hepatologists, and I think it gives them the option to use the best-in-class therapies, whatever the genotype. So whilst we are seeing changes from competition, and that is somewhat inevitable, we still believe we're in a strong position with regards to our portfolio.

嘿，傑夫，我是凱文楊。我再補充一點關於開局的情況。整個HCV市場的啟動次數整體下降，本季（第三季）下降了51,000次，而上一季為53,000次。正如你所預料的那樣，也出現了一些變化，因為它是我們市場份額的新進入者。價格方面有輕微的影響。但正如吉姆所指出的那樣，這種定價和份額效應將在第四季度產生更大的影響，並延續到 2018 年。我必須說，我認為，正如吉姆所指出的那樣，我們2018年仍然處於非常有利的地位。我們確實在2018年保留了商業保險和D部分醫療保險中丙型肝炎治療方案的可用性。這是我們的肝病專家要求我們做的，我認為這使他們可以選擇使用一流的療法，無論基因型如何。因此，儘管我們看到競爭帶來了一些變化，而且這在某種程度上是不可避免的，但我們仍然相信，就我們的投資組合而言，我們處於一個強大的地位。

And our next question comes from the line of Michael Yee with Jefferies.

下一個問題來自 Jefferies 的 Michael Yee。

Following along in hep C, realizing that this is an issue, I think, people want to see stabilize out. How are you thinking about the dynamics you mentioned as you go into 2018 and the step-down you could see in fourth quarter and then going into 2018? In other words, where do you think patient starts and market share start to stabilize out? Do you think you see that by the first half of '18? How are you thinking about that so investors can get confident about flattening out?

鑑於丙肝疫情的發展，人們意識到這是一個問題，我認為，大家都希望看到疫情穩定下來。您如何看待您提到的進入 2018 年的各種動態，以及您可能在第四季度和進入 2018 年時看到的下滑趨勢？換句話說，您認為患者數量和市場佔有率會在什麼情況下開始趨於穩定？你認為 2018 年上半年就能實現嗎？您如何看待這個問題，才能讓投資人對經濟趨於平穩充滿信心？

Mike, it's Robin. I'll take that. As you know, we updated guidance for 2017, but we're not going to use this call to really start to talk about 2018. I will go back to the overall factor that Jim mentioned. Clearly, looking at patient starts, net pricing, (inaudible) and treatment duration. To Jim's earlier comments, clearly, pricing and contracting, we'll continue to work through and complete by the end of the year. But the impact of those other variables are things that we'll work into as we provide guidance to you for 2018 next February.

麥克，我是羅賓。我接受。如您所知，我們更新了 2017 年的指導意見，但我們不會利用這次電話會議真正開始討論 2018 年的事情。我會回到吉姆提到的那個整體因素。顯然，要看患者的起始治療、淨定價、（聽不清楚）和治療持續時間。針對吉姆之前的評論，很顯然，定價和合約問題，我們將繼續努力，並在年底前完成。但其他變數的影響，我們將在明年二月向您提供 2018 年指導意見時加以考慮。

Mike, let me just add a little bit to Robin's comments. I think I've said on the last call that in terms of patient volume, it was looking like between 185,000 and about 200,000. We would sense that it's tracking to the kind of higher end of that in terms of patient starts. What happens next year, as Robin says, remains to be seen. The numbers that we have for Europe, that we put in our original guidance, seem to be pretty solid, and so did Japan. So the rate of treatment is still going on out there.

麥克，我只想補充一下羅賓的評論。我想我在上次電話會議上說過，就患者數量而言，預計在 185,000 到 200,000 之間。我們感覺，就患者數量而言，它正朝著較高水準發展。正如羅賓所說，明年會發生什麼，還有待觀察。我們最初給出的歐洲數據，以及日本的數據，似乎都相當可靠。所以治療工作仍在繼續。

Okay. Let me just ask it this way then. If there -- has a new competitor coming on, but the contracts are basically stabilized, do you think the large step-down or drop is basically going to be seen this quarter and then should stabilize out? In other words, we're going to see the drop here coming up, and then that's really the big change here.

好的。那我就換個方式問吧。如果出現新的競爭對手，但合約基本上穩定，您認為大幅下滑或下降是否會在本季出現，然後趨於穩定？換句話說，接下來我們會看到價格下跌，而這才是真正的重大改變。

Yes. Michael, no, I would say that I think that in the fourth quarter, you'll see, more fully, the impact of new competition on both price and share. But we're not through the contracting process. So again, I think that, to Robin's point, we will issue guidance. We'll have a more complete picture of what 2018 looks like as we get closer to there. I can just tell you that, again, we hope to -- we believe strongly, we'll be able to maintain access for physicians and patients in 2018, similar to what we had in 2017. We have been able to maintain parity and preferred access with the major payers, at least, in the Medicare and commercial books of business with those that we've worked with so far. Again, we also have maintained parity access in the VA. Where we will continue to rein disadvantaged is in the Medicaid segment, particularly the Medicaid managed care segment. But again, in those scenarios, we're mainly seeing Mavyret replace Zepatier. But in the areas where we got the majority of our business and had the greatest access, we will remain either at parity or preferred access, and we are very confident in our ability, when all of this shakes out, to continue to remain market leader from a share perspective.

是的。邁克爾，不，我認為在第四季度，你會更全面地看到新的競爭對價格和市場份額的影響。但我們還沒有完成合約簽訂流程。所以，我再次認為，正如羅賓所說，我們會發布指導意見。隨著2018年的臨近，我們將對2018年的情況有更全面的了解。我可以再次告訴大家，我們希望——我們堅信，我們將能夠在 2018 年保持醫生和患者的就醫便利，就像我們在 2017 年所做的那樣。至少在我們目前合作過的醫療保險和商業保險業務中，我們已經能夠與主要支付方保持平等地位和優先准入。此外，我們也維持了退伍軍人事務部醫療服務中的平等獲取途徑。我們將繼續在醫療補助計劃領域，特別是醫療補助計劃管理式醫療領域，以遏制弱勢群體。但同樣，在這些情況下，我們主要看到的是 Mavyret 取代 Zepatier。但在我們獲得大部分業務和擁有最大市場准入機會的地區，我們將保持與競爭對手持平或享有優先准入，我們非常有信心，當這一切塵埃落定時，我們能夠繼續保持市場份額的領先地位。

And our next question comes from the line of 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 shifting gears away from hep C. You recently presented data for 0976 at the AASLD conference. So wondering if you could maybe give us a little bit more details in terms of your view of the benefit/risk there, manageability of some of the lipid changes, where this mechanism could potentially fit into the paradigm relative to the other therapies in your portfolio and the next steps for that asset.

或許應該把研究方向從C肝轉移轉移。您最近在 AASLD 會議上展示了 0976 的數據。所以，我想請您詳細說說您對該療法的益處/風險的看法，以及一些脂質變化的可控性，這種機制在您產品組合中的其他療法中可能扮演的角色，以及該療法的下一步計劃。

Brian, it's Norbert. Thanks for the question. Yes, we presented data, 12-week data, by the way. We couldn't do a longer study because we didn't have the supporting talks, client talks done. That's done now, of course. And the data showed that there was a good reduction in liver fat as measured by MRI. There were also certain markers of fibrosis. Biomarks of fibrosis were down. Not all of them, but it looked -- and there was a dose response. So it was a very nicely behaved compound. And as John said in his prepared remarks, we will almost certainly start combination studies sometime next year. Now you mentioned one side effect that we did see that was clearly drug-related, was triglyceride elevations. Now 2 comments to that. First of all, out of the 16, the large majority, 12 occurred in patients that already started with high triglycerides of 250 or higher. Secondly, some of these triglyceride elevations were reduced to a lesser grade with continued dosing. So it seems to be an immediate effect. We think, actually, by the way, (inaudible) it's a weight redistribution effect to shut down lipid synthesis and then the triglycerides come by releasing VLDL from the liver. That's one hypothesis that we have. In the future, how we're going to manage this is, first of all glostatins or fish oil; and number two, by excluding those patients that have high triglycerides at baseline. We think this is manageable, as I said, either with [con meds] or with choosing the patients carefully. And over time, the triglycerides may go down to normal levels. Again, we don't have data right now beyond 12 weeks. We will see that in the next study.

布萊恩，我是諾伯特。謝謝你的提問。是的，我們展示了數據，順便說一下，是12週的數據。我們無法進行更長時間的研究，因為我們還沒有完成相關的支援性討論和客戶洽談。當然，現在已經完成了。MRI 測量數據顯示，肝臟脂肪含量明顯降低。此外，也存在一些纖維化標記。纖維化生物標記下降了。雖然不是全部，但看起來是這樣——而且存在劑量反應關係。所以它是一種性質非常優良的化合物。正如約翰在事先準備好的演講稿中所說，我們幾乎肯定會在明年某個時候開始聯合研究。您剛才提到了一種我們確實觀察到的、明顯與藥物相關的副作用，那就是三酸甘油酯升高。現在有兩點要補充。首先，在 16 例病例中，絕大多數（12 例）發生在三酸甘油酯水平已經很高（250 或更高）的患者身上。其次，隨著持續用藥，部分三酸甘油酯升高的情況減輕。所以這似乎是一種立竿見影的效果。我們認為，實際上，（聽不清楚）這是一種體重重新分配效應，目的是關閉脂質合成，然後三酸甘油酯是透過從肝臟釋放 VLDL 而產生的。這是我們提出的假設。未來，我們將採取的管理方式是：首先，使用抑酸劑或魚油；其次，排除那些基線三酸甘油酯水平高的患者。正如我所說，我們認為這是可以控制的，要么使用[藥物]，要么仔細選擇病人。隨著時間的推移，三酸甘油酯可能會降至正常水平。再次強調，我們目前還沒有超過 12 週的數據。我們將在下一項研究中看到這一點。

And 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。

Norbert, I'll follow up with another question for you. It's concerning filgotinib. And I'm just wondering if you could give us a sense of the approximate cumulative exposure to the drug and what number of VTE events you've seen. I know the studies are blinded, but presumably, you've been notified and you're watching for these events. And then perhaps, you could comment on where do you think that there's a class signal here or molecule-specific signals or no signal.

諾伯特，我還有一個問題想問你。filgotinib令人擔憂。我想問一下，您能否大致介紹一下該藥物的累積暴露量以及您觀察到的 VTE 事件數量？我知道這些研究是雙盲的，但想必您已經收到通知，並且正在關注這些事件。然後，或許您可以評論一下，您認為這裡存在類別訊號、分子特異性訊號還是沒有訊號。

Geoff, thanks for the question. So the one study that's published, where they looked at background venous -- venothrombolic events in RA points to a number of 6 per 1,000 patient years. So it's very rare, but it does occur in inflammatory conditions. Now if you look across all the studies that have been published with JAK inhibitors, there's a pretty good variation. And while I don't -- and by the way, we also believe that there is insufficient evidence that any of these JAK inhibitors, that it's drug-related. The numbers are just too small. So we are up to a 1,300-patient years' experience with filgotinib across all our clinical studies. And I don't want to tell you the number that we have in terms of these events. It's very small, but if you look at the rate per patient-year exposures, we're at the very low end of what other companies have seen and what has been reported in literature. And the last thing I would like to add, Geoff, if you believe that these events are drug-related and if you believe that the mechanism has to do with JAK2 inhibition, and as I think I mentioned last time, there is a paper published that looked at a JAK2 knockout mouse, and those mice had higher platelet levels, so it's entirely possible that, somehow, this venothrombolic events have to do with high platelet levels. Then we should not have that effect because, number one, filgotinib doesn't inhibit JAK2; and number two, we actually see platelets going down in our studies. So that's what is going to be the extent of my wisdom that I have on this subject.

傑夫，謝謝你的提問。因此，已發表的一項研究，即針對 RA 患者的背景靜脈血栓事件的研究，指出每 1000 患者年發生 6 例。所以這種情況非常罕見，但確實會在發炎性疾病中發生。現在，如果你縱觀所有已發表的關於 JAK 抑制劑的研究，你會發現結果差異相當大。雖然我不這麼認為——順便說一句，我們也認為沒有足夠的證據表明這些 JAK 抑制劑與藥物有關。數字太小了。因此，我們所有臨床研究中使用filgotinib的經驗累計已達1300患者年。我不想告訴你我們舉辦了多少這類活動。雖然數量很少，但如果你看一下每位患者每年的暴露率，我們處於其他公司所見以及文獻報導的最低水平。最後我想補充一點，Geoff，如果你認為這些事件與藥物有關，並且你認為其機制與JAK2抑制有關，正如我上次提到的，有一篇論文研究了JAK2敲除小鼠，這些小鼠的血小板水平較高，因此，靜脈血栓事件很可能與高血小板水平有關。那麼我們就不應該出現這種效果，因為，第一，filgotinib 不抑制 JAK2；第二，我們在研究中實際上看到血小板下降。這就是我對這個問題的全部見解了。

And our next question comes from the line of Matthew Harrison with Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

If I could ask something on Yescarta. I guess I was looking for some of your insight about some of the dynamics that could influence the launch. And I guess, 2 that come to mind for me are, one, can you talk a little bit about how the drug is going to be paid for? Obviously, DRGs don't cover the total costs, especially for Medicare patients, and so how you think the financial impact to hospitals will play into the use. And then second, maybe you could comment on the impact of the other sort of clinical trials that are going on at these centers, which I'm sure are in high demand, and how you think that could impact the launch?

我想問一下關於Yescarta的問題。我想聽聽您對可能影響產品發布的一些動態因素的看法。我想到的兩個問題是，第一，您能談談這種藥物的費用將如何支付嗎？顯然，DRG 無法涵蓋全部費用，尤其是對於 Medicare 患者而言，因此您認為醫院的財務影響將如何影響其使用。其次，您能否談談這些中心正在進行的其他類型的臨床試驗的影響？我相信這些試驗的需求量很大。您認為這些試驗會對產品上市產生怎樣的影響？

Sure, well, I'll take the first part, and then maybe some combination, yes, Alessandro on the second. But let me step back for a minute and just remind that the payer mix for -- we believe, and I think we feel fairly confident about this, will be about 50% to 60% commercial. The rest, largely Medicare, a little bit of Medicaid. And remember, within Medicare, there's a portion that is DRG-related and a portion that isn't. All the discussions that Kite folks have had with payers to this point, both government and private payers, have indicated that they believe that they will cover Yescarta beginning at approval while they update their medical policies and so forth. Now there's a difference between covering and reimbursement, obviously. And reimbursement levels will vary by payer segment and also by the contractual agreements that exist within -- between hospitals and payers, which are independent, anything that we're involved with. We do believe that, over time, that Medicare DRG segments will probably, at most, grow to approximate about 1/3 of the payer mix. They won't be close to that in the first year or so because, again, most of these centers are PPS-exempt, meaning that they are not reimbursed based on DRGs, and it's more about fee-for-service and more like a commercial-type reimbursement. Even with that, these hospitals are well-adept at using non-CAR T DRGs until they actually have a CAR T-specific DRG. And I think it's important to remember that what we're dealing with right now is not new. Every hospital-based product launched in the last 20 years has done so without a DRG at launch. So it's not like they're having to figure this out for the first time. So there's experienced people in these cancer centers that do this for stem cell transplants, that do this for every product, hospital-based, that they've had come in. And last thing I'll say and then turn it to Alessandro is just one of the prerequisites that these cancer centers being certified to administer CAR T was a determination that reimbursement would be sufficient to make this financially feasible for them based on their payer mix. So we don't -- obviously, we would love to have, and we will have, in a couple of years, a CAR T-specific DRG. We have NATAP and things we can do in the interim. But this is not novel ground, and hospitals are very adept at using other DRGs and other codes to get sufficient reimbursement.

當然，第一部分我來做，然後第二部分可能是某種組合，是的，亞歷山德羅負責第二部分。但讓我先退後一步，提醒大家一下，我們認為，而且我們對此相當有信心，支付方構成中商業支付將佔 50% 到 60%。其餘部分主要來自聯邦醫療保險（Medicare），少量來自醫療補助（Medicaid）。請記住，在醫療保險中，有一部分與DRG相關，一部分與DRG無關。到目前為止，Kite 公司與政府和私人支付方進行的所有討論都表明，他們相信在 Yescarta 獲得批准後，他們會在更新醫療政策等期間開始承保該藥物。顯然，保險和報銷是有差別的。報銷水準會因支付方群體而異，也會因醫院和支付方（彼此獨立）之間存在的合約協議而異，無論我們參與其中的是什麼。我們相信，隨著時間的推移，Medicare DRG 細分市場可能只會成長到支付方組合的約 1/3。在最初的一年左右，他們不會接近這個目標，因為這些中心大多是 PPS 豁免的，這意味著他們不是根據 DRG 獲得報銷，而是更多地按服務收費，更像是商業類型的報銷。即便如此，這些醫院仍然非常擅長使用非 CAR T DRG，直到他們真正擁有 CAR T 特異性 DRG 為止。我認為重要的是要記住，我們現在面臨的問題並非新鮮事。過去 20 年推出的所有醫院相關產品在推出時都沒有 DRG（診斷相關分組）。所以這並不是他們第一次遇到這種情況。所以這些癌症中心有經驗豐富的人員，負責幹細胞移植，負責醫院引進的每一種產品。最後，我要說的是，然後把這個問題交給 Alessandro，這些癌症中心獲得 CAR-T 療法認證的先決條件之一是，根據他們的支付方組合，報銷金額足以使這項療法在經濟上可行。所以我們現在還沒有——顯然，我們很想擁有，而且在幾年內我們將擁有一個 CAR T 特異性 DRG。我們有NATAP，而且在此期間我們還可以做一些事情。但這並非什麼新鮮事，醫院非常擅長利用其他DRG和其他代碼來獲得足夠的報銷。

Yes, this is Alessandro. I'll elaborate why that the dynamics, I think, will also change dramatically because we are dealing with a lifesaving treatment. And we expect that Yescarta will become the standard of care for diffuse large B-cell lymphoma after all therapies. So it is a transformative therapy, and we think that the community, the physician and the payers will work together towards making sure that Yescarta is available to patients. So we have done the clinical trials in diffuse large B-cell lymphoma in around 15 centers, mainly focused in the United States of America. And now we are expanding to more center in the U.S. and also in Europe in terms of not only diffuse large B-cell lymphoma but also our pivotal trials in other B-cell malignancies. So we are very confident that we will have this support from the community from the regulators to implement this trial, and we work together to make sure that we serve both the patient needs that are in relapsed/refractory diffuse large B-cell lymphoma for whom Yescarta is indicated and, of course, for patient that will be eligible for our clinical trials.

是的，這是亞歷山德羅。我認為，由於我們正在進行一項拯救生命的治療，因此情況也會發生巨大變化，我將詳細闡述原因。我們預計，在所有療法之後，Yescarta 將成為瀰漫性大 B 細胞淋巴瘤的標準治療方案。因此，這是一種變革性的療法，我們認為社區、醫生和支付方將共同努力，確保患者能夠獲得 Yescarta 治療。因此，我們已經在大約 15 個中心開展了瀰漫性大 B 細胞淋巴瘤的臨床試驗，主要集中在美國。現在，我們正在將業務擴展到美國和歐洲的更多中心，不僅針對瀰漫性大B細胞淋巴瘤，也針對其他B細胞惡性腫瘤的關鍵性試驗。因此，我們非常有信心能夠得到社區和監管機構的支持，以便進行這項試驗。我們將共同努力，確保滿足復發/難治性瀰漫性大B細胞淋巴瘤患者的需求（Yescarta適用於這些患者），當然，也滿足符合我們臨床試驗條件的患者的需求。

Hey, Matthew, it's Kevin. There's always a worry with the start of a new kind of market about, will there be commercial patients versus clinical trials? I remember in the early days of RA, that was always a worry. But my experience is that there's always a demand with high-need patients, as Alessandro said, for treatments from an FDA-approved product. And as Alessandro says, Kite had, by far -- have, by far, the biggest clinical trial base upon which to introduce Yescarta. So with 40-some centers that have actually had clinical experience, that's a really strong base for the commercial introduction.

嘿，馬修，我是凱文。每當一種新型市場出現時，總是會有人擔心，商業患者和臨床試驗之間會孰輕孰重？我記得在患有類風濕性關節炎初期，這始終是一個令人擔憂的問題。但我的經驗是，正如亞歷山德羅所說，對於有特殊需求的患者來說，總是有 FDA 批准的產品的治療需求。正如 Alessandro 所說，Kite 擁有迄今為止最大的臨床試驗基礎，可以以此為基礎推出 Yescarta。因此，擁有 40 多個具備臨床經驗的中心，這為商業推廣奠定了非常堅實的基礎。

And 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。

I did want to drill down on the HCV pricing a bit more, was kind of a 2-part question. The first is, does Gilead itself understand how the average revenue per patient will change quarter-over-quarter in Q4? Or is it somewhat of a fluid situation where you yourselves aren't entirely sure yet how price would change? And then second, I was wondering if you could -- if you do have somewhat of an understanding, could you give us some sense of the magnitude of the quarter-over-quarter change in average revenue per patient in Q4 over Q3? Is it like 5%, 10%? Whatever you can tell us would be appreciated.

我確實想更深入了解HCV的定價，這其實是包含兩個部分的問題。首先，吉利德本身是否了解第四季每位患者的平均收入將如何較上季變化？或者說，情況比較複雜，你們自己也還不能完全確定價格會如何變動？其次，我想請教一下，如果您對第四季度每位患者的平均收入與第三季度相比，環比變化幅度如何？是5%還是10%？您能告訴我們什麼，我們都將不勝感激。

Yes. No, I would say, it's -- again, as we mentioned, we're still in the process right now. We've made a lot of good progress, but it's not complete. So we're not in a position to speak about that right now. But again, what we can signal to you is that pricing, in general, is similar across genotypes, and it has gravitated down towards 8-week genotype 1 pricing. And again, you'll see that more fully reflected in the fourth quarter, although, as I said, the process of 2018 contracting is not fully complete during this quarter.

是的。不，我想說，正如我們之前提到的，我們目前仍在進行中。我們已經取得了很大進展，但還沒有完成。所以我們現在不方便談論這個問題。但我們可以再次向您表明，總體而言，不同基因型的價格相似，並且已經趨向於 8 週齡基因型 1 的價格。而且，你會在第四季度更充分地看到這一點，儘管正如我所說，2018 年的合約簽訂過程在本季度還沒有完全完成。

Hey, Phil, for this quarter, quarter 3 versus quarter 2, it was, by far, driven by patient starts and share. It was a 4-point different going from 80% to 76%. It was just a tad. It was just a little of pricing. But as Jim says, that will become a bigger effect in Q4.

嘿，菲爾，就本季度而言，第三季度與第二季度相比，主要驅動因素是患者數量和市場份額。從 80% 降到 76%，相差 4 個百分點。只是一點點。只是價格上的一點小問題。但正如吉姆所說，這種情況在第四季會更加明顯。

And our next question comes from the line of Alethia Young with Credit Suisse.

下一個問題來自瑞士信貸的 Alethia Young。

It's probably for you, Norbert. Just wanted you to talk a little bit about the interim kind of PSC readout in 9674. Just -- will we get efficacy? General thoughts? And then also, Norbert, just after some of the discussion in the community around FXRs with Ocaliva, I guess, I just wanted to get your general thoughts on some of the tolerability around liver and lipids and different things.

這很可能是給你的，諾伯特。只是想請您談談 9674 中的臨時 PSC 讀數。只是──我們能取得療效嗎？整體想法？另外，Norbert，鑑於社區裡對 Ocaliva 治療 FXR 的一些討論，我想聽聽你對肝臟、脂質和其他方面的耐受性的一些看法。

Alethia, I think this question was about FXR or the ACC in it or both?

Alethia，我覺得這個問題是關於FXR或其中的ACC，還是兩者都有？

FXR?

FXR？

The 967 -- FXR.

967——FXR。

FXR, okay.

FXR，好的。

Yes, the 9674.

是的，是9674。

Now so you will see -- so we have a Phase II study kind of ending. We should have data fairly soon. That's going to be a 24-week study, by the way. And you will see data then presented probably at EASL. We haven't really decided yet where we're going to go with those. But what we have seen, it's well -- there's no effect. It's well tolerated. We think -- I think we have disclosed that it releases FGF19. That has been published. So the only question is the GI-generated FGF19 that then goes to the liver, is that enough to have the same efficacy as, for instance, an FXR agonist that actually gets physically to the liver? That's the question we haven't answered yet. That will come with the Phase II study, so we hope we'll have some data on that. But FXR, clearly, it's a proven mechanism with OCA. The FLINT study was published in -- a few years ago in NEJM. Again, the OCA has some drawbacks, and we think with a gut-restricted FXR agonist that we have, we could probably potentially solve some of those downsides.

現在你會看到──我們的第二期研究即將結束。我們應該很快就能拿到數據。順便說一下，這項研究將持續24週。屆時您可能會在 EASL 會議上看到相關數據。我們還沒有真正決定如何處理這些項目。但我們看到的卻是──沒有任何效果。它耐受性良好。我們認為——我認為我們已經披露了它將釋放 FGF19。已經發表了。所以唯一的問題是，胃腸道產生的 FGF19 進入肝臟後，是否足以達到與實際到達肝臟的 FXR 激動劑相同的療效？這是我們尚未解答的問題。這將在二期臨床試驗中獲得結果，所以我們希望屆時能得到一些相關數據。但很顯然，FXR 是一種經過驗證的 OCA 機制。FLINT 研究幾年前發表在《新英格蘭醫學雜誌》。再次強調，OCA 有一些缺點，我們認為，憑藉我們擁有的這種腸道限制性 FXR 激動劑，我們或許能夠解決其中的一些缺點。

And our next question comes from the line of Robyn Karnauskas with Citi.

下一個問題來自花旗銀行的 Robyn Karnauskas。

I just want to follow up on one of the comments you made about like the hospitals that you're training believe that their reimbursement -- that there's a valuable reimbursement environment for CAR T. I just have a question around that. So I guess, first, is like, are you incorporating any value-based pricing at these -- for payers? Is that incorporated at all so we know how to model the price per patient? And the second is, like, tell me more about what that means for the hospital. Does that mean that they're going to be very comfortable trying CAR T and not worrying about reimbursement? Or do you think that they'll still want to treat patients more fully just to get more comfortable with the reimbursement environment?

我想就您之前提到的一點進行補充說明，即您培訓的醫院認為CAR-T療法的報銷環境很有價值。我對此有個疑問。所以我想，首先，你們是否在這些支付方中採用了基於價值的定價策略？是否已將這一點納入考慮，以便我們了解如何對每位患者的價格進行建模？第二個問題是，請詳細說說這對醫院意味著什麼。這是否意味著他們可以很放心地嘗試 CAR-T 療法，而不用擔心報銷問題？還是你認為他們仍然會為了更好地適應報銷環境而願意為病人提供更全面的治療？

Sure, Robyn. Thank you. Just touching on value-based pricing at first. We are in ongoing and active discussions with, really, all commercial and government payers, including CMS. And I can convey to you, there are varying degrees of interest and ability to execute value-based contracts. It truly does vary by payer. You may be aware there's a lot of operational complexities to this, in addition to just government price barriers to implementing this across all payer segments. But we have communicated our openness to considering solutions, any and all solutions, to improve patient access regardless of what they may be. It may end up not being value-based pricing. It could be something different. But we're very open to it. There's a reason why, to our knowledge, we don't -- at least, historically, we haven't seen value-based pricing in oncology. It's not the easiest to execute under current regulations. But we're open to that. I think that -- remember what I said that a lot -- part of the certification process and the vetting process at these hospitals is these are hospitals that are very used to having to do the same thing with stem cell transplants, understanding who is a commercial patient, who is a Medicare patient, where am I going to get reimbursed at this level, where am I going to get reimbursed at that level. So they really are conducting the same type of calculus here, and one of the reasons why they end up coming onboard is they feel they can make this work for them.

當然可以，羅賓。謝謝。首先簡單談談基於價值的定價。我們正在與包括 CMS 在內的所有商業和政府支付方進行持續積極的討論。我可以向你們說明，人們對執行基於價值的合約的興趣和能力各不相同。確實會因付款方而異。您可能已經意識到，除了政府在所有支付方群體中實施這項政策的價格障礙之外，這其中還存在許多操作上的複雜性。但我們已經證明，我們願意考慮任何能夠改善患者就醫體驗的解決方案，無論這些方案是什麼。最終可能並非基於價值的定價。也可能是其他原因。但我們對此非常開放。據我們所知，腫瘤學領域之所以沒有採用基於價值的定價是有原因的——至少從歷史上看，我們還沒有看到腫瘤學領域採用基於價值的定價。在現行法規下，這並非易事。但我們對此持開放態度。我認為——記住我之前說過很多次——這些醫院的認證過程和審查過程的一部分是，這些醫院非常習慣於對乾細胞移植做同樣的事情，了解誰是商業病人，誰是醫療保險病人，我可以在哪個級別獲得報銷，在哪個級別獲得報銷。所以他們實際上是在進行同樣的計算，他們最終加入的原因之一是他們覺得他們可以從中獲利。

Yes. I think, Robyn, just for modeling purposes, I would just take up $373,000 as the price per patient. I think that's probably a good way to think about it for you.

是的。羅賓，我覺得，就建模而言，我會把每位病人的價格定為 373,000 美元。我覺得這可能是你思考這個問題的一個好方法。

And our next question comes from the line of Terence Flynn with Goldman Sachs.

我們的下一個問題來自高盛的 Terence Flynn。

Was just wondering, following the launch of bictegravir next year, obviously, in addition to the shared capture from some other regimens, just wondering if you'd expect to see a meaningful step-up in the rate of conversion to TAF from your Viread regimens here. Or do you expect that the rate would actually continue as we've seen over the last few years?

我只是想知道，隨著比克替拉韋明年上市，除了從其他一些治療方案中共享資源外，您是否預期從您這裡使用維瑞德治療方案的患者轉化為TAF的比例會有顯著提高。或者您認為這一增速會像過去幾年那樣繼續下去？

Yes, maybe just a first comment. Anyone, jump in. It would be hard to see a more rapid conversion to TAF than we've seen in the 2 years since -- and really, less than 2 years since the launch of Genvoya. As we said, we're at 56%. We would anticipate that by -- considering the mid-February PDUFA date for B/F/TAF, that we could be up around 2/3. So that has exceeded our expectations. So there will be a -- again, by 2020, we anticipate that the only folks still remaining on TDF will largely be Truvada for PrEP at that point. So there will already have been a significant conversion to TAF even before B/F/TAF launches. What we -- obviously, we see TAF as, really, the culmination, the first regimen, really, without trade-offs. And what we think we're going to see at that point, and what I believe we'll see, is a lot of conversion of, not only business that isn't TAF yet, but business that is already TAF onto B/F/TAF. Particularly, I mean, we have seen an uptick recently in the last quarter or so in patients starting on Descovy, plus dolutegravir. And what physicians tell us is, is that in a lot of cases, this is in preparation for what they expect to do in the first quarter of next year. It's very logical to them and to us. But more importantly, to them, switch opportunity for them to, obviously, make -- get them on a single pill. So I'm not that surprised we're seeing an uptake in that, and I think that bodes very well for B/F/TAF.

是的，或許可以先發表一下第一則評論。誰都進來。自 Genvoya 推出以來的兩年內（實際上，還不到兩年），我們很難看到比這更快的向 TAF 的轉換速度。正如我們所說，我們目前的完成度為 56%。我們預計，到 2 月中旬 B/F/TAF 的 PDUFA 日期，我們可能會達到 2/3 左右。這超出了我們的預期。因此，到 2020 年，我們預計屆時繼續服用 TDF 的人將主要服用 Truvada 用於 PrEP。因此，即使在 B/F/TAF 發布之前，也已經有大量用戶轉向 TAF。顯然，我們認為 TAF 是真正的巔峰之作，是第一個真正意義上的治療方案，沒有任何妥協。我們認為屆時將會看到，而且我相信我們將會看到，不僅許多尚未成為 TAF 的企業會轉型為 B/F/TAF，而且許多已經是 TAF 的企業也會轉型為 B/F/TAF。特別是，我的意思是，最近一個季度左右，我們看到開始接受 Descovy 加多替拉韋治療的患者人數有所增加。醫生告訴我們，在許多情況下，這是為了準備明年第一季他們計劃進行的工作。對他們和我們來說，這都很合乎邏輯。但更重要的是，對他們來說，這是一個改變的機會，顯然，讓他們能夠——只服用一種藥丸。所以，我對這種趨勢的興起並不感到驚訝，我認為這對 B/F/TAF 來說是一個非常好的兆頭。

Yes, Terence, I would just give a shout out for how well our colleagues in Europe are doing. As Jim said, that's Genvoya. I mean, terrific that already 75% of our HIV business in Germany is already across to TAF-based regimens. But it's also Descovy. Jim makes a great point. If you look at the uptake, and we've supplied you with some slides, you look at the uptake in Italy, Descovy is going terrifically. And that's a great platform for B/F/TAF. So we couldn't be happier about how we're doing this year with our HIV portfolio.

是的，特倫斯，我只想特別讚揚一下我們在歐洲的同事們做得非常出色。正如吉姆所說，那就是 Genvoya。我的意思是，太棒了，我們在德國的 HIV 業務中已有 75% 轉向了基於 TAF 的治療方案。但它也是 Descovy。吉姆說得很有道理。如果你看一下市場接受度，我們已經向你提供了一些幻燈片，看看義大利的市場接受度，Descovy 的發展非常出色。對於 B/F/TAF 來說，這是一個絕佳的平台。因此，我們對今年在愛滋病防治領域的成果感到無比滿意。

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 now that you relatively quickly wrapped up the Kite deal, I'm curious where your mindset is at this point regarding potential additional M&A and if you do have an appetite for it, what types of assets would be of greatest interest to you now that you have a new commercial product and platform in the fold?

既然你們已經相對迅速地完成了 Kite 的交易，我很好奇你們目前對潛在的其他併購持何種態度，如果你們確實有併購意願，那麼在你們擁有了新的商業產品和平台之後，哪些類型的資產最能引起你們的興趣？

Hey, Cory, it's John Milligan. Thanks for the question. So a couple of things to say. The Kite acquisition was done very rapidly, and of course, we are spending a lot of time now figuring out how to best work with our colleagues at Kite. I can say that they had -- and we are quite interested in bringing in technology that will enhance our ability to move CAR T forward, not -- to the next generations of CAR T. As we had mentioned on the call when we acquired Kite, when we announced the acquisition, that we see this as a platform that will require continuous innovation. And so we are quite active in bringing in technologies, which will help us move CAR T forward. Having said that, it's also true that M&A is going to be an ongoing activity at Gilead, where we will be in a constant state of evaluation of opportunities to bring in revenues or technologies that, we think, will help enhance our portfolio and our top line for the future. So I can tell you we're very, very active. I'm not going to give you hints as to what we might be looking at, but I can say the group that we've put together is very, very good, and we are constantly evaluating stuff internally and with our board. So I would expect this to continue to be quite active in the coming years.

嘿，科里，我是約翰·米利根。謝謝你的提問。有幾點要說。Kite 的收購完成得非常迅速，當然，我們現在正在花很多時間思考如何才能最好地與 Kite 的同事們合作。我可以肯定地說，他們擁有——而且我們非常有興趣引進能夠提升我們推進CAR-T療法發展能力的技術，而不是——是能夠推動CAR-T療法邁向下一代的技術。正如我們在收購Kite的電話會議上，也就是宣布收購時所提到的那樣，我們認為這是一個需要持續創新的平台。因此，我們非常積極地引進新技術，這將有助於我們推動 CAR-T 療法的發展。話雖如此，併購也將是吉利德的一項持續性活動，我們將持續評估各種機會，以引入我們認為有助於增強我們產品組合和未來營收的收入或技術。我可以告訴你，我們非常非常活躍。我不會透露我們可能在研究什麼，但我可以肯定地說，我們組建的團隊非常非常優秀，而且我們一直在內部以及與董事會一起評估各種事項。因此，我預計未來幾年這一領域仍將相當活躍。

And our next question comes from the line of Andrew Peters with Deutsche Bank.

下一個問題來自德意志銀行的安德魯彼得斯。

One more on the new patient starts side. I guess, I just wanted to drill into the third quarter a bit more. If we look at first quarter, the second quarter was kind of more flattish on the new patient starts side, and then we saw kind of a bit of a dip now. Just wanted to understand if there's any kind of seasonality within that new patient start component. Or is it really just more consistently that fewer patients are actually starting therapy? And on the seasonality-side, if you look historically, say, to last year, how has the fourth quarter performed relative to prior quarters?

新病人那邊又多了一位。我想，我只是想更深入地探討一下第三季的情況。如果我們看一下第一季度，第二季度新患者數量成長比較平穩，然後我們看到現在出現了一些下滑。我只是想了解一下，新患者數量的增長是否存在季節性規律。或者，實際情況是否只是更少的患者真正開始接受治療？從季節性角度來看，如果回顧歷史數據，例如去年，第四季相對於前幾季表現如何？

Yes, I'll start. This is Jim. And I would say, I agree. It looked like it was a larger drop in the third quarter relative to earlier quarters. Obviously, what helped us in the beginning of the year was the fact that we had the mid-year launch of Epclusa, and that had obviously some carryover into the early part of the year. The other thing I'd say, and again, I don't mean to get into the weeds here, but I will just say that when you actually normalize this year based upon holidays and trading days, which a lot of the IMS and other companies will do for you but don't routinely do, we've pretty much seen a fairly steady 2% month-on-month decline in patient starts basically since the start of the year. Again, there's different numbers of days and holidays in each area. So in reality, it's been less of a drop just from the second to the third quarter and more consistent and steady decline. The reason we were saying very correctly that we saw higher levels of starts than we thought was we actually started at a higher point than we thought. So there was more starts in the first half of the year than we thought. But the general trend of patient starts declining relatively consistently throughout the year has really been in place since January, and we don't expect that to change in the fourth quarter.

好的，我先來。這是吉姆。我同意。與前幾季相比，第三季的降幅似乎更大。顯然，年初對我們有所幫助的是我們在年中推出了 Epclusa，這顯然對年初產生了一些積極影響。還有一點我想說，我不想在這裡深入探討細節，但我只想說，當你根據假日和交易日對今年的數據進行正常化處理時（很多 IMS 和其他公司都會幫你做，但他們通常不會這樣做），我們基本上看到，自年初以來，患者新發病例數每月都穩定下降 2%。同樣，每個地區的假期天數和假日數量都不一樣。所以實際上，從第二季度到第三季度，降幅並不大，而是持續穩定的下降趨勢。我們之所以說我們看到的開球率比我們預想的要高，是因為我們實際的開球點比我們預想的要高。所以今年上半年的比賽場次比我們預想的還要多。但患者就診數量全年相對持續下降的總體趨勢從 1 月開始就一直存在，我們預計第四季度不會改變。

Andrew, typically, Europe is more seasonally sort of orientated. We did see France and Spain come down a little bit in the third quarter, although, nicely, Italy was quite strong because there's a lot bigger opening now. There is a general access across all genotypes to HCV therapy, and there's a lot of untreated patients there. Typically, fourth quarter is as good, if not a little bit stronger than third quarter in Europe. I don't think there's really much seasonality, as Jim points out, between third and fourth quarter in the U.S.

安德魯，通常來說，歐洲的氣候更受季節影響。我們看到法國和西班牙在第三季有所下滑，不過令人欣慰的是，義大利表現相當強勁，因為現在市場開放的幅度更大了。丙型肝炎病毒感染者普遍都能獲得丙型肝炎治療，但仍有許多患者未接受治療。通常來說，歐洲第四季與第三季一樣好，甚至可能略好一些。正如吉姆指出的那樣，我認為美國第三季和第四季之間並沒有太大的季節性差異。

And our next question comes from the line of Umer Raffat with Evercore.

我們的下一個問題來自 Evercore 的 Umer Raffat。

I actually wanted to drill down on hep C a little more, and I just want to make sure I'm thinking about this correctly because these numbers sounded -- I just wanted to make sure I'd lock them in. So the high end of 2017 guidance for your hep C implies that the fourth quarter will have a run rate of somewhere between $4 billion and $5.4 billion. So am I doing the math right there? And is that the starting number we should think about as we head into 2018?

我其實想更深入地了解丙型肝炎，我只是想確保我的想法是正確的，因為這些數字聽起來——我只是想確保我能確定它們是正確的。因此，2017 年C肝治療績效指引的上限意味著第四季的年化收入將在 40 億美元至 54 億美元之間。我這樣算對嗎？那麼，這是我們在邁入 2018 年時應該考慮的起始數字嗎？

Umer, again, we can't jump ahead and start to give you kind of numbers for 2018. As Jim said, we're finalizing all of our contracts. And there are the 3 variables: patient starts, which still continues to be a big variable; there is the pricing; and there is the share. The one thing that's now come off the table really is duration because the use of Harvoni, use of Epclusa is pretty standardized now. So that's not really a variable. Yes, you can do the maths by taking away our first 3 quarters from the guidance that Robin took you through. But we really don't wish to go any further than where we are with, I think, a 2017 (inaudible) on our original guidance in hepatitis C and have done superbly with over-exceeding our HIV guidance. But we'll get to 2018 when we get to 2018.

Umer，我們還是無法提前提供你 2018 年的具體數據。正如吉姆所說，我們正在敲定所有合約。有三個變數：患者數量（這仍然是一個很大的變數）；定價；以及市場份額。現在唯一可以排除在外的因素是持續時間，因為 Harvoni 和 Epclusa 的使用現在已經相當標準化了。所以這其實並不是一個變數。是的，你可以按照 Robin 指導你的前三個季度的數據進行計算。但我們真的不想在丙型肝炎的最初指導方針上走得更遠，我認為，我們目前的指導方針是 2017 年（聽不清楚）制定的，而且我們在愛滋病毒指導方針方面做得非常出色，遠遠超過了預期。但到2018年的時候，我們自然會迎來2018年。

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

我們的下一個問題來自 Katherine Xu 與 William Blair 的對話。

I am just wondering about the HCV China business that you guys could potentially drum up there, considering 10 million people infected, although I have a number of 43 million. I'd just say 10% of them could potentially pay out of pocket. That could be 1/3 of the U.S. market, so that could be quite substantial. I wonder what's your overall thoughts on that market?

我只是好奇你們在中國能開拓多少丙型肝炎業務，考慮到有 1000 萬人感染，雖然我掌握的數據是 4300 萬人。我估計其中 10% 的人可能需要自費。這可能占美國市場的三分之一，所以金額相當可觀。我想知道您對這個市場的整體看法是什麼？

Katherine, you're making me nervous here. I think it'll be, I think, a staged launch in China. I mean, what's remarkable is, in the last 12 months, how the China FDA have changed their regulations and are -- particularly for products that we've got in the viral area, very, very motivated to see these products come to market. We will have a relatively small organization in China that's quite deliberate. We want to really do the right thing and be highly compliant and bring our therapies very responsibly to the Chinese market. We've known the Chinese opinion leaders for a long time, even though we haven't actually had an office in China. So that gave us the confidence and the platform upon which to start to put in our organization. We have a very seasoned general manager. It will be, as you say, a private market launch to begin with. We have missed the national listings, which are now -- are really now closed for the coming year. But in 2018, we will be trying to bridge from the private market into provincial reimbursement. And when the next round of national authorization opens, then we will try to get SOVALDI, Harvoni, Epclusa and Vemlidy, for that matter, because HBV is a very prevalent disease in China, into international or onto national listing. So we want to walk before we can run, but there's no doubt that our antivirals are much needed for the infection rates in China.

凱瑟琳，你讓我感到緊張。我認為，在中國，這將是一場分階段的發表會。我的意思是，值得注意的是，在過去的 12 個月裡，中國國家藥品監督管理局改變了他們的法規，特別是對於我們病毒領域的產品，他們非常非常積極地希望看到這些產品上市。我們將在中國建立一個規模相對較小、運作較為謹慎的組織。我們真心希望做正確的事，嚴格遵守規定，以非常負責任的態度將我們的療法引入中國市場。我們認識中國的意見領袖已經很久了，儘管我們實際上在中國沒有設立辦事處。這給了我們信心和平台，讓我們得以開始在我們的組織中成長。我們擁有一位經驗非常豐富的總經理。正如你所說，它最初將以私募市場的方式推出。我們錯過了全國性的榜單，這些榜單現在——真的已經關閉，不再接受新的一年的榜單了。但2018年，我們將嘗試從私人市場過渡到省級報銷。當下一輪國家授權開放時，我們將努力將 SOVALDI、Harvoni、Epclusa 和 Vemlidy 等藥物納入國際或國家藥物目錄，因為乙肝病毒在中國是一種非常流行的疾病。所以我們希望先學會走路再學會跑步，但毫無疑問，中國的感染率非常需要抗病毒藥物。

And we have time for one more question. Our final question for today comes from the line of Ying Huang with Bank of America Merrill Lynch.

我們還有時間回答最後一個問題。我們今天的最後一個問題來自美國銀行美林證券的黃穎女士。

I have one for Genvoya. On Slide 29, last month, we see a dip in TRx. I mean, am I reading the tea-leaves too much? Or there's something behind that dip or just one blip in the market? And then secondly, on HCV, if I take your high end of the guidance for this year, $9 billion, I get to about $1.36 billion in 4Q. So that's still 40% drop from 3Q. Do you think that's mostly because of the U.S. market dynamics or also you're seeing a dropoff in Europe and the other countries as well for HCV?

我有一個Genvoya的。在第 29 張投影片中，我們看到上個月 TRx 出現下滑。我的意思是，我是不是想太多了？或者說，這次下跌背後另有隱情，還是只是市場中一次小的波動？其次，關於C型肝炎，如果我採用你今年給出的最高預期，即 90 億美元，那麼第四季約為 13.6 億美元。所以，這仍然比第三季下降了40%。你認為這主要是因為美國市場動態造成的，還是也看到歐洲和其他國家C型肝炎病例也在下降？

Yes, so maybe start with Genvoya. No, we are not seeing anything. This month-to-month fluctuation is just based on, I wouldn't call it seasonality, but just the number of holidays and so forth. But there is -- the uptake of Genvoya has not shown any attenuation at all and couldn't be going stronger. Again, as we said, 56%, we expect to get to about 2/3 by the time of the launch of the B/F/TAF in terms of the percent that's TAF. So no worries there. The second question was just in terms of the dropoff in the fourth quarter. Again, that's the first quarter on hep C, where we will see the -- more fully, the impact of both the dynamics we spoke about in pricing, where it is now consistent across genotypes, and it's come down more towards genotype 1, 8-week levels. And again, also, more of the impact of share. So both of those things are reflected in that. And again, that's what -- and that's reflective of the updated guidance that was provided earlier in this call.

是的，或許可以先從 Genvoya 開始。不，我們什麼也沒看到。這種月度波動只是基於…我不會稱之為季節性因素，而僅僅是假日數量等等因素造成的。但事實是──Genvoya 的普及率絲毫沒有減弱，反而還在持續成長。正如我們所說，目前 TAF 佔比為 56%，我們預計到 B/F/TAF 推出時，TAF 的比例將達到 2/3 左右。所以不用擔心。第二個問題只是關於第四季的下滑情況。再說一遍，這是丙肝的第一個季度，我們將更全面地看到我們之前談到的價格動態的影響，現在價格在各種基因型中都保持一致，並且價格已經更接近基因型 1 的 8 週水平。此外，還有更多市場份額的影響。所以這兩點都體現在那件事上了。再次強調，這正是——這也反映了本次電話會議早些時候提供的最新指導意見。

And Ying, we will see some competitive effects running into Europe. That will be a country-by-country. I have to say that Epclusa is doing really, really well in Europe and is the #1 hepatitis C product that's being used across all genotypes in the European market. So we believe we got a very able competitor to the new market entrant in Epclusa.

還有，Ying，我們會看到一些競爭效應蔓延到歐洲。這將逐個國家進行。我必須說，Epclusa 在歐洲的表現非常出色，是歐洲市場上所有基因型丙型肝炎治療產品中排名第一的產品。因此，我們相信我們找到了一個非常有能力的競爭對手，來對抗新進入市場的 Epclusa。

And just to reiterate again, maybe it didn't play out exactly from the 4 different dynamics that drive revenue as we thought. Patient starts were higher. Price and share, at least later in the year, were lower. But 2017 HCV revenue will fall well within the original guidance that was issued last February, so we feel very good about that.

再次重申一下，也許實際發生的情況並沒有完全按照我們預想的4種不同的收入驅動因素來發展。患者起始數量較高。價格和份額，至少在今年下半年，都出現了下降。但 2017 年 HCV 營收將遠低於去年 2 月發布的最初預期，因此我們對此感到非常樂觀。

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

今天的問答環節到此結束。我謹將發言權交還給李成先生，請他作總結發言。

Great. Thank you, Karen, 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.

偉大的。謝謝凱倫，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 your participation in today's conference. This does conclude the program, and you may now disconnect. Everyone, have a great day.

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