吉利德科學 (GILD) 2016 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Welcome to the Gilead Sciences' fourth quarter 2016 earnings conference call. My name is Chelsea and I will be your conference operator today.

    歡迎參加吉利德科學公司2016年第四季財報電話會議。我叫切爾西,今天將由我擔任你們的會議接線生。

  • (Operator Instructions)

    (操作說明)

  • And as a reminder, this conference call is being recorded. I would now like to turn the call over to Sung Lee, Vice President of Investor Relations. Please go ahead.

    再次提醒大家,本次電話會議正在錄音。現在我將把電話交給投資人關係副總裁李成先生。請繼續。

  • - VP of IR

    - VP of IR

  • Thank you, Chelsea, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full-year 2016. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

    謝謝你,切爾西,大家下午好。今天股市收盤後不久,我們發布了一份新聞稿,公佈了 2016 年第四季和全年的獲利結果。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 Kevin Young, Chief Operating Officer. Also in the room with us for the Q&A session are: Norbert Bischofberger, Executive Vice President of Research and Development, and Chief Scientific Officer; and Jim Meyers, Executive Vice President, Worldwide Commercial Operations.

    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;以及營運長凱文·楊。與我們一同參加問答環節的還有:研發執行副總裁兼首席科學官諾伯特·比肖夫伯格;以及全球商業營運執行副總裁吉姆·邁耶斯。

  • Before we begin formal remarks, 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.

    在我們正式發言之前,請允許我提醒各位,我們將就產品、候選產品、財務預測和資本使用等問題發表前瞻性聲明,包括計劃和預期,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,並可能導致實際結果與這些聲明存在重大差異。

  • 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.

    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. I will now turn the call over to Robin.

    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。現在我會把通話轉給羅賓。

  • - EVP and CFO

    - EVP and CFO

  • Thank you, Sung, and good afternoon, everyone. We are pleased to share our results for the fourth quarter and full-year 2016. I will first review financials, and Kevin and John will make a few comments. 2016 was a productive year for Gilead, with strong performance across the HIV and cardiopulmonary franchises.

    謝謝宋,大家午安。我們很高興與大家分享2016年第四季和全年的業績。我會先審閱財務報表,凱文和約翰將提出一些意見。2016 年對吉利德來說是碩果累累的一年,在 HIV 和心肺疾病領域都取得了強勁的業績。

  • The year was not without its challenges, notably navigating the changing dynamics of the HCV market in countries around the world. We continue to be an operationally and financially efficient organization with high operating margins and a healthy balance sheet as 2017 begins.

    這一年並非一帆風順,尤其需要因應世界各地丙型肝炎市場不斷變化的動態。2017 年開始,我們依然是一家營運和財務效率高、營運利潤率高、資產負債表健康的企業。

  • Total revenues were $7.3 billion for the fourth-quarter 2016, with non-GAAP diluted earnings per share of $2.70. This compares to revenues of $8.5 billion and non-GAAP earnings per share of $3.32 for the same period last year.

    2016 年第四季總營收為 73 億美元,非 GAAP 稀釋後每股收益為 2.70 美元。相比之下,去年同期營收為 85 億美元,非 GAAP 每股收益為 3.32 美元。

  • The full year 2016 total revenues were $30.4 billion, down 7% year over year. Non-GAAP diluted earnings was $11.57 per share for the year, down from $12.61 per share for the same period last year. Product sales for the year was $30 billion, down 7% year over year, driven by lower HCV sales, partially offset by increased sales in HIV and other therapeutic areas.

    2016 年全年總營收為 304 億美元,年減 7%。本年度非GAAP稀釋後每股收益為11.57美元,低於去年同期的每股12.61美元。今年產品銷售額為 300 億美元,年減 7%,主要原因是丙型肝炎病毒 (HCV) 銷售額下降,但愛滋病毒 (HIV) 和其他治療領域的銷售額成長部分抵消了這一影響。

  • Turning to the US, product sales for the year were $19.3 billion, now down 9% year over year. HCV product sales were $8.4 billion down 32% year over year, driven primarily by lower Harvoni demand, higher discounts impairments. Within HCV sales, Epclusa, which was launched in June of last year, achieved $1.6 billion of sales in 2016. HIV and other antiviral product sales for 2016 were $9.1 billion, up 27% year over year due to strong uptake of our top-based regimen.

    再來看美國市場,本年度產品銷售額為 193 億美元,較去年同期下降 9%。HCV 產品銷售額年減 32%,達到 84 億美元,主因是 Harvoni 需求下降、折扣減損增加。在丙型肝炎病毒(HCV)的銷售中,去年 6 月推出的 Epclusa 在 2016 年實現了 16 億美元的銷售額。2016 年 HIV 和其他抗病毒產品的銷售額為 91 億美元,年成長 27%,這主要歸功於我們以頭皮細胞為基礎的治療方案的強勁普及。

  • Turning to Europe, product sales for the year were $6.1 billion, down 15% year over year, primarily due to lower HCV patient starts and unfavorable currency movements. In Japan, product sales for the year were $2.5 billion, up 31% year over year, primarily driven by higher sales of Sovaldi and Harvoni which were launched in Japan in May 2015 and September 2015, respectively. The increases were partially offset by the mandatory price reduction on our HCV product of 32%, effective last March.

    再來看歐洲,該年度產品銷售額為 61 億美元,較去年同期下降 15%,主要原因是 HCV 患者數量減少和不利的匯率波動。在日本,該年度產品銷售額為 25 億美元,年增 31%,主要得益於 Sovaldi 和 Harvoni 的銷售成長,這兩款產品分別於 2015 年 5 月和 2015 年 9 月在日本上市。上述成長部分被去年 3 月起生效的 HCV 產品 32% 的強制降價所抵銷。

  • Turning to expenses for the full-year 2016, non-GAAP R&D expenses were $3.7 billion, up 32% compared to the prior year, reflecting the continued progression of the product pipeline including milestone payments related to advancing clinical studies and the purchase of an FDA priority review voucher. Non-GAAP SG&A expenses were $3.2 billion, which represents a slight decrease compared to the prior year, driven by lower branded prescription drug fee expenses, partially offset by expenses to support new product launches in geographic expansion.

    2016 年全年,非 GAAP 研發費用為 37 億美元,比上年增長 32%,這反映了產品線的持續進展,包括與推進臨床研究相關的里程碑付款以及購買 FDA 優先審評券。非GAAP SG&A費用為32億美元,與前一年相比略有下降,主要原因是品牌處方藥費用支出減少,但部分被支持地域擴張的新產品上市費用所抵消。

  • Turning to the Idenix Merck litigation [matter], which is ongoing. As of December 31, 2016, we have not recorded any charges to our financial statement as we believe it is not probable under accounting rules that the Company will incur a loss on this matter. Our Annual Report on Form 10-K will contain detailed disclosures on the amount of potential damages and royalties Gilead could owe Merck in the event the Appellate Court upholds the jury's verdict.

    接下來談談 Idenix 和 Merck 的訴訟案,目前仍在審理中。截至 2016 年 12 月 31 日,我們尚未在財務報表中記錄任何費用,因為我們認為根據會計準則,本公司不太可能在此事上遭受損失。我們的 10-K 表格年度報告將詳細披露,如果上訴法院維持陪審團的裁決,吉利德可能需要向默克支付的潛在損害賠償和特許權使用費金額。

  • Turning to cash flows. We generated $16.7 billion in cash from operations for the full-year 2016, and $3.5 billion for the quarter. We continue to return capital to shareholders through dividends and share repurchases. During the fourth quarter, we utilized $1 billion in cash to repurchased 13 million shares, bringing our total 2016 share repurchases to $11 billion and 123 million shares.

    接下來我們來看現金流。2016 年全年,我們從經營活動中獲得了 167 億美元的現金,其中該季度獲得了 35 億美元的現金。我們將繼續透過分紅和股票回購向股東返還資本。第四季度,我們動用 10 億美元現金回購了 1,300 萬股股票,使我們 2016 年的股票回購總額達到 110 億美元,回購股數達到 1.23 億股。

  • Earlier today, we announced a 10% increase in our quarterly dividend from $0.47 to $0.52 per share, which will become effective in the first quarter of 2017. This increase underscores the confidence of the Board and Management and the strength of the business and future cash flows.

    今天早些時候,我們宣布將季度股息提高 10%,從每股 0.47 美元增至 0.52 美元,該調整將於 2017 年第一季生效。這一成長凸顯了董事會和管理層的信心,以及公司業務的實力和未來現金流的良好前景。

  • In 2017, leveraging our capital to pursue external opportunities to expand our R&D pipeline is our primary focus. As a result, we will reduce the level of capital dedicated to share repurchases this year and focus a greater percentage of our shareholder return on our dividend. We currently have $9 billion remaining under our 2016 share repurchase authorization and we'll utilize it over time to maintain our current share count. Over the longer term, we may be opportunistic with additional share repurchases.

    2017年,我們的主要重點是利用我們的資本尋求外部機會,以擴大我們的研發管線。因此,我們將減少今年用於股票回購的資金水平,並將股東回報的更大比例用於分紅。我們目前在 2016 年的股票回購授權下還剩 90 億美元,我們將逐步利用這筆資金來維持我們目前的股票數量。從長遠來看,我們可能會伺機進行額外的股票回購。

  • Finally, I would like to cover our full year 2017 non-GAAP financial guidance, summarized on slides 21 through 25 in the Earnings Presentation available on our corporate website. Given the unique dynamics of the HCV market and patient starts which have the greatest impact on our HCV revenues, we have split our net product sales guidance between non-HCV and HCV net product revenue.

    最後,我想介紹一下我們 2017 年全年非 GAAP 財務預期,該預期總結在我們公司網站上提供的盈利演示文稿的第 21 至 25 頁。鑑於 HCV 市場和患者數量的獨特動態對我們的 HCV 收入影響最大,我們將淨產品銷售預期分為非 HCV 淨產品收入和 HCV 淨產品收入。

  • Non-HCV net product sales are expected to be in the range of $15 billion to $15.5 billion. HCV net product sales are expected to be in the range of $7.5 billion to $9 billion. Our guidance is subject to a number of uncertainties, including: accuracy of our estimates of HCV patient starts in 2017; unanticipated pricing pressures from payers and competitors; lower than anticipated market share in HCV; slower-than-anticipated growth in our HIV franchise; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers.

    非丙型肝炎病毒(HCV)產品的淨銷售額預計在 150 億美元至 155 億美元之間。預計丙型肝炎病毒(HCV)產品的淨銷售額將在75億美元至90億美元之間。我們的指導意見受到許多不確定因素的影響,包括:我們對 2017 年 HCV 患者起始治療數量的估計是否準確;來自支付方和競爭對手的意外定價壓力;HCV 市場份額低於預期;HIV 產品線增長速度低於預期;由於與商業和政府支付方的現有合約和未來談判,折扣、退款和未來談判,折扣、退款和增加談判。

  • A larger than anticipated shift in payer mix to more highly discounted payer segments, such as PHS, FFS, Medicaid and the VA. Market share and price erosion caused by the introduction of generic versions of PDF and a fixed-dose combination of FTC, TDF outside the US later this year. An uncertain global macroeconomic environment, potential amendments to the Affordable Care Act or other government actions that could have the effect of lowering prices or reducing the number of insured patients, as well as volatility in foreign currency exchange rates.

    支付方結構轉變為折扣力度較大的支付方群體(如 PHS、FFS、Medicaid 和 VA)的幅度超出預期。今年晚些時候,美國以外地區將推出 PDF 的仿製藥和 FTC、TDF 的固定劑量組合,這將導致市場份額和價格下降。全球宏觀經濟環境的不確定性、《平價醫療法案》的潛在修訂或其他政府行為可能導致價格下降或投保患者人數減少,以及外匯匯率的波動。

  • Slide 24 provides further information on Gilead's estimates of HCV total market patient starts across key commercial geographies which is the primary factor used in developing our 2017 HCV product sales guidance. We expect our non-GAAP product gross margins to be in the range of 86% to 88%. We expect our non-GAAP R&D expenses to be in the range of $3.1 billion to $3.4 billion. We expect our non-GAAP SG&A expenses to be in the range of $3.1 billion to $3.4 billion.

    第 24 頁提供了有關吉利德對主要商業區域 HCV 總市場患者起始數量的估計的更多信息,這是我們制定 2017 年 HCV 產品銷售指導的主要因素。我們預計非GAAP產品毛利率將在86%至88%之間。我們預計非GAAP研發費用將在31億美元至34億美元之間。我們預計非GAAP SG&A費用將在31億美元至34億美元之間。

  • For the full-year, our non-GAAP effective tax rate is expected to be in the range of 25% to 28%. We anticipate the full year diluted EPS impact of acquisition-related, stock-based compensation and other expenses to be in the range of $0.84 to $0.91 per share. I would like to now turn the call over to Kevin.

    預計全年非GAAP有效稅率將在25%至28%之間。我們預計,與收購相關的股權激勵和其他費用對全年稀釋後每股盈餘的影響將在每股 0.84 美元至 0.91 美元之間。現在我想把電話交給凱文。

  • - COO

    - COO

  • Thank you, Robin, and good afternoon, everyone. Before beginning my comments on the quarter, I'd like to formally introduce our new Executive Vice President of Commercial Operations, Jim Meyers, who joins the Earnings Call Team. Jim has been at the Company for 20 years and has been instrumental in building out the Company's commercial operations in North America, including leading successful product launches across the Company's portfolio of products. I personally have worked with Jim for more than 10 years and can vouch for his unique insights into the complexities of the various markets in therapeutic areas for which we serve patients.

    謝謝你,羅賓,大家下午好。在開始對本季業績發表評論之前,我想正式介紹一下我們新任商業營運執行副總裁吉姆·邁耶斯,他將加入財報電話會議團隊。Jim 在公司工作 20 年,在公司北美商業營運的拓展中發揮了重要作用,包括領導公司旗下所有產品的成功上市。我自己與吉姆共事超過 10 年,可以證明他對我們所服務患者的各個治療領域市場的複雜性有著獨特的見解。

  • Now, I would like to provide an update on our commercial performance during the fourth quarter and share a few highlights from markets around the world. Let me say from the outset that I see the very highest levels of operational excellence across Gilead. People everyday supporting best-in-class products in viral, cardiovascular and pulmonary diseases. But as I will describe in some detail, there are very different external dynamics when comparing treatments for chronic disease like HIV, with treatments that can cure a disease like hepatitis C.

    現在,我想就我們第四季的商業業績作一次匯報,並分享來自世界各地市場的一些亮點。首先我想說的是,我看到了吉利德公司在營運方面展現出的最高水準。人們每天都在支持病毒性疾病、心血管疾病和肺部疾病領域的一流產品。但正如我將要詳細描述的那樣,在比較治療愛滋病等慢性疾病的療法和治療丙型肝炎等疾病的療法時,外部動態存在著非常不同的差異。

  • Starting with HIV, without question, 2016 was one of our strongest years, led by the rapid adoption of TAF-based regimens. In the US, total HIV and other antiviral revenue was $2.4 billion in the fourth quarter, up 20% year over year and down 6% sequentially. As a reminder, third-quarter results benefited from a one time favorable adjustment of $332 million through rebate reserves primarily related to TDF-based regimens.

    就 HIV 而言,毫無疑問,2016 年是我們取得最大成就的一年,這主要得益於 TAF 療法的快速普及。在美國,第四季 HIV 和其他抗病毒藥物的總收入為 24 億美元,年增 20%,季減 6%。需要提醒的是,第三季業績受益於一次性有利調整 3.32 億美元,主要透過與 TDF 療法相關的退款儲備實現。

  • Excluding this one-time adjustment, there was a 7% sequential increase in the fourth quarter driven by robust underlining growth and some inventory build, consistent with prior years. Genvoya, our first TAF-based single tablet regimen, surpassed $1 billion in revenue in its first year. No other HIV product has achieved this level of success and this performance is a testament to the clinical profile of TAF in combination with Elvitegravir in one tablet.

    剔除這項一次性調整後,第四季環比成長 7%,這主要得益於強勁的基礎成長和庫存增加,與往年情況一致。Genvoya 是我們第一個以 TAF 為基礎的單片療法,上市第一年收入就超過了 10 億美元。沒有其他 HIV 產品能達到這樣的成功水平,這種表現證明了 TAF 與 Elvitegravir 聯合用藥的臨床療效。

  • As highlighted in slide 33, Genvoya quickly became the most prescribed regimen across all US treated HIV patient groups within nine months of launch. At the end of 2016, TAF-based regimens made up 37% of Gilead's HIV prescription volume in the treatment market.

    如投影片 33 所示,Genvoya 在上市後的九個月內迅速成為美國所有接受治療的 HIV 患者族群中最常用的治療方案。截至 2016 年底,基於 TAF 的治療方案佔吉利德 HIV 治療市場處方量的 37%。

  • This is remarkable, considering that Genvoya was launched a little more than a year ago, and Odefsey and Descovy have been on the market for just nine months. Most patients on these products switch from Gilead's older regimens due the improved safety profile of TAF. Additionally, an estimated 10% of patient switches are coming from non-Gilead therapies, resulting in incremental growth for the franchise.

    考慮到 Genvoya 推出才一年多,而 Odefsey 和 Descovy 上市只有九個月,這確實令人矚目。由於 TAF 的安全性較高,大多數使用這些產品的患者都是從吉利德的舊療法轉而使用 TAF。此外,據估計,有 10% 的患者轉用吉利德的療法,這為該療法帶來了增量增長。

  • Turning to Europe, total HIV and other antiviral revenue was $705 million in the fourth quarter, down 6% year over year and down 3% sequentially. This was driven by negative foreign exchange and a full-quarter impact of an imposed price reduction in France. Strong uptake of Genvoya continues across launched markets in Europe, including Germany, Spain and the UK. In Spain, Genvoya is the most prescribed regimen to switch patients and the second most prescribed regimen for treatment-naive patients.

    再來看歐洲市場,第四季 HIV 和其他抗病毒藥物的總收入為 7.05 億美元,年減 6%,季減 3%。這主要是由於外匯匯率波動不利以及法國強制降價政策帶來的整個季度的影響。Genvoya 在歐洲已推出的市場(包括德國、西班牙和英國)持續獲得強勁的市場認可。在西班牙,Genvoya 是轉用治療患者最常使用的治療方案,也是初治患者第二常用的治療方案。

  • And just last week, I am delighted to say that Genvoya began its commercial introduction in France. As many of you know, France is the largest developed HIV market outside the US. Finally, to complete the European major market picture, we hope to have Genvoya introduced in Italy by early quarter two.

    就在上週,我很高興地宣布 Genvoya 已在法國開始商業化推廣。正如你們許多人所知,法國是美國以外最大的已開發愛滋病市場。最後,為了完善歐洲主要市場的格局,我們希望在第二季初將 Genvoya 引入義大利。

  • Turning to Descovy and Odefsey outside the US, we now have the products available in 13 and 11 countries, respectively. Additional launches are anticipated in 2017 as pricing and reimbursement discussions continue. Beyond TAF, there continues to be a strong uptake for the use of Truvada for pre-exposure prophylaxis, or PrEP.

    就美國以外的 Descovy 和 Odefsey 而言,我們現在分別在 13 個國家和 11 個國家/地區銷售這些產品。隨著定價和報銷談判的繼續,預計 2017 年將有更多產品上市。除了 TAF 之外,Truvada 在暴露前預防(PrEP)方面的應用仍然非常廣泛。

  • At the end of 2016, approximately 110,000 people in the US were using Truvada for this indication. When used in combination with other prevention strategies, Truvada for PrEP can have a meaningful impact on public health by helping to reduce HIV transmission rates.

    截至 2016 年底,美國約有 11 萬人使用 Truvada 治療此適應症。當與其他預防策略結合使用時,Truvada 用於 PrEP 可以透過幫助降低 HIV 傳播率,對公共衛生產生有意義的影響。

  • The majority of PrEP prescribing to date is concentrated in four cities where awareness is high, most notably, San Francisco. The city recently announced a reduction in HIV infection rates as a result of greater testing, the use of antiretrovirals for treatment and the adoption of PrEP. There is an opportunity to replicate this success in other areas across the United States.

    到目前為止,大部分 PrEP 處方集中在四個認知度較高的城市,其中最值得注意的是舊金山。該市最近宣布,由於加強檢測力度、使用抗逆轉錄病毒藥物進行治療以及推廣 PrEP,愛滋病毒感染率有所下降。美國其他地區有機會複製這種成功經驗。

  • And Gilead has been encouraged to play a more prominent role in PrEP education and has done so via the hiring of a field based team. We believe that Truvada for PrEP will continue to be an integral part of our growth in HIV in the US, as communities embrace the public health benefits of prevention.

    吉利德公司被鼓勵在 PrEP 教育方面發揮更重要的作用,並透過聘請一支實地團隊來實現這一目標。我們相信,隨著社區接受預防帶來的公共衛生益處,Truvada 用於 PrEP 將繼續成為我們在美國 HIV 防治領域發展的重要組成部分。

  • Before leaving HIV, one event that should be highlighted in 2017 is the loss of the tenofovir disoproxil fumarate exclusivity in some countries outside the US. We have forecasted the financial impact of this event on our non-HCV sales guidance, as shown in slide 22, referred to earlier by Robin.

    在結束關於 HIV 的討論之前,2017 年值得關注的一件事是,富馬酸替諾福韋酯在美國以外的一些國家失去了獨家銷售權。我們已經預測了這件事對我們非 HCV 銷售指引的財務影響,如 Robin 前面提到的投影片 22 所示。

  • Nevertheless, we believe the rapid adoption of TAF for HIV treatments and the uptake in Truvada for PrEP in the United States underpin a strong Gilead growth trajectory, some 15 years after the introduction of Viread in 2001.

    儘管如此,我們認為,TAF 在 HIV 治療領域的快速普及以及 Truvada 在美國用於 PrEP 的廣泛應用,為吉利德公司強勁的增長勢頭奠定了基礎,而這距離 Viread 於 2001 年推出已經過去了大約 15 年。

  • Turning to HCV. In the US, total HCV revenue was $2 billion in the fourth quarter, down 15% year over year and down 1% sequentially. Total HCV treatment starts in the US for the full year of 2016 were an estimated 231,000, approximately 250,000 -- excuse me, approximately 25,000 less patient starts than in 2015.

    轉向丙型肝炎。在美國,第四季HCV總營收為20億美元,年減15%,季減1%。2016 年全年,美國 HCV 治療的起始人數估計為 231,000 人,比 2015 年減少了約 25 萬人——抱歉,約 25,000 人。

  • There were a few one-time events that impacted this number in 2016. Notably, one, the opening of access of two of the largest US commercial payers, which happened in Q1. Two, the increase in the number of patients treated through the VA system, especially in Q2; and three, the treatment of Genotype 2 and Genotype 3 warehouse patients following the approval of Epclusa in the second half of 2016.

    2016 年發生了一些一次性事件,對這個數字產生了影響。值得注意的是,第一季美國兩家最大的商業支付方開放了准入。第二,透過 VA 系統接受治療的患者人數增加,尤其是在第二季度;第三,在 2016 年下半年 Epclusa 獲得批准後,對基因型 2 和基因型 3 倉庫患者的治療。

  • Since we do not anticipate the same or similar factors repeating themselves this year, our expectation is that patient starts in 2017 will be lower than in 2016. Above and beyond the factors I just cited, the decline we expect is also due to a change in the profile of patients coming into treated care.

    由於我們預計今年不會再出現相同或類似的因素,因此我們預計 2017 年的患者起始數量將低於 2016 年。除了我剛才提到的因素之外,我們預期的下降也是由於接受治療的患者群體組成發生了變化。

  • A greater number of patients have less advanced disease and thus, there is less urgency to begin using curative DAAs like Harvoni and Epclusa. In addition, an increasing percentage of untreated patients face circumstances that favor delay, such as ongoing drug or alcohol use, co-morbidities or unstable living conditions.

    許多患者的病情都比較輕微,因此,使用 Harvoni 和 Epclusa 等治癒性 DAA 的緊迫性也較低。此外,越來越多的未接受治療的患者面臨著導致治療延誤的情況,例如持續吸毒或酗酒、合併症或不穩定的生活條件。

  • Turning to Europe, total HCV revenue in the fourth quarter was $628 million, down 26% year over year and up 4% from the previous quarter. The sequential performance was primarily a reflection of the small bounce back in patient starts following normal summer seasonality in markets like Spain and Italy. Despite the year-end pick-up, we expect patient starts to continue to decline in 2017.

    再來看歐洲市場,第四季HCV總營收為6.28億美元,較去年同期下降26%,季增4%。此連續業績主要反映了西班牙和義大利等市場在正常的夏季季節性波動後,患者數量小幅反彈。儘管年底有所回升,但我們預計 2017 年患者數將持續下降。

  • Countries like Germany, France and the UK are fast exhibiting the same characteristics as the US. Spain and Italy continued to experience regulatory constraints and the treatment of F0 to F2 patients in these countries has been limited. In Japan, product sales for the fourth quarter were $340 million, down 77% year over year and down 31% sequentially, due to the decline in patient starts and the entry of another company's product to the market.

    德國、法國和英國等國家正迅速展現出與美國相同的特徵。西班牙和義大利繼續受到監管限制,這些國家對 F0 至 F2 患者的治療受到限制。在日本,第四季產品銷售額為 3.4 億美元,年減 77%,環比下降 31%,原因是患者數量減少以及另一家公司的產品進入市場。

  • Our local intelligence points to some unique dynamics in Japan that are potentially behind the profound decline in patient starts, relative to other countries. First, recall that approximately 40,000 patients were treated with another DAA regimen prior to the launch of Sovaldi, decreasing those who were very sick and warehoused.

    我們當地的情報顯示,日本存在一些獨特的動態因素,這些因素可能是導致日本新發病例數相對於其他國家大幅下降的原因。首先,回想一下,在 Sovaldi 上市之前,大約有 40,000 名患者接受了另一種 DAA 療法的治療,這減少了重症患者和被隔離的患者數量。

  • Second, up to 40% of HCV-infected patients in Japan are over 80 years old and often under the care of a general practitioner, not a specialist, who better understands the importance of treating patients regardless of age. Third, there is a lower awareness of hepatitis C and the fact there is a cure among the general Japanese population.

    其次,在日本,高達 40% 的 HCV 感染患者年齡超過 80 歲,他們通常由全科醫生而非專科醫生治療,而全科醫生更了解不分年齡治療患者的重要性。第三,日本民眾對C型肝炎及其治癒方法的認識較低。

  • Before leaving our HCV results, I would like to return to my theme of earlier. This disease has unique dimensions, the most important of which is that can be cured. And thanks to Harvoni, it can be cured in as little as eight weeks in a Genotype 1 patient. Whilst earlier HCV therapies have their limitations, you can still observe the dynamics that a cure has on patient starts following the introduction of a new class of medicines, as shown in slide 37.

    在結束關於丙型肝炎病毒檢測結果的討論之前,我想回到我之前提到的主題。這種疾病具有獨特的特點,其中最重要的是它可以治癒。由於採用 Harvoni 的治療,基因 1 型患者最快可在八週內治癒。儘管早期的 HCV 療法有局限性,但你仍然可以觀察到,在引入一類新的藥物後,治癒對患者病情發展的影響,如幻燈片 37 所示。

  • As we look as best we can at the near-term horizon, we see 2017 total HCV patient starts declining relative to 2016 in all major markets. By comparison, the US numbers are still vastly higher relative to treatment levels before the advent of DAAs. Gilead's role as market leader is to appropriately work with the various components of HCV care, providers, professional associations and infected individuals where allowed to bring patients into specialists' care and successfully cure them of a destructive virus.

    從近期來看,所有主要市場的 2017 年 HCV 患者總數均開始相對於 2016 年有所下降。相比之下,美國的治療水平仍然遠高於 DAA 出現之前的水平。吉利德作為市場領導者的角色是與丙型肝炎治療的各個組成部分、醫療服務提供者、專業協會和受感染者進行適當合作(在允許的情況下),將患者送至專科醫生處接受治療,並成功治愈這種破壞性病毒。

  • Moving on to hepatitis B, Vemlidy, our TAF-based therapy for the treatment of chronic hepatitis B was approved by the FDA in November, the Japanese Ministry of Health, Labour and Welfare in December, and the European Commission last month. This is the first medication approved to treat chronic hepatitis B in nearly a decade.

    接下來是乙肝,我們基於 TAF 的慢性乙肝治療藥物 Vemlidy 已於 11 月獲得美國食品藥物管理局 (FDA) 的批准,12 月獲得日本厚生勞動省的批准,上個月獲得歐盟委員會的批准。這是近十年來首個獲準用於治療慢性B型肝炎的藥物。

  • While still very early, we are pleased with the uptake of Vemlidy in the US. Initial feedback from healthcare providers suggests that they strongly believe the long term safety profile of Vemlidy represents an important new development for people living with chronic hepatitis B.

    雖然現在還處於非常早期的階段,但我們對Vemlidy在美國的接受度感到滿意。醫療保健提供者的初步回饋表明,他們堅信 Vemlidy 的長期安全性代表慢性乙型肝炎患者的一項重要新進展。

  • Finally, as I highlighted last quarter, our US Cardiovascular Team continues to deliver impressive results. Letairis and Ranexa revenue totaled $436 million for the quarter and achieved nearly $1.5 billion for the year. I would now like to turn the call over to John. John?

    最後,正如我在上個季度所強調的那樣,我們的美國心血管團隊繼續取得了令人矚目的成就。Letairis 和 Ranexa 本季營收總計 4.36 億美元,全年營收接近 15 億美元。現在我想把電話交給約翰。約翰?

  • - President and CEO

    - President and CEO

  • Thanks, Kevin. I'd like to make a few closing remarks before we get to your questions. Gilead was very productive in 2016, launching four important new therapies, two for people with HIV and two for the treatment of viral hepatitis. As mentioned by Robin and Kevin, we are very pleased with the progress of Gilead's TAF-based regimens based on the benefits they provide.

    謝謝你,凱文。在回答你們的問題之前,我想做幾點總結。吉利德在 2016 年成果豐碩,推出了四款重要的新療法,其中兩款用於治療 HIV 患者,兩款用於治療病毒性肝炎。正如 Robin 和 Kevin 所提到的,我們對 Gilead 基於 TAF 的治療方案的進展非常滿意,因為它們帶來了許多益處。

  • With the successful launches of Odefsey and Descovy, we now offer three different and important new options for patients with HIV. We continue to innovate in HIV and next week, we will present data from a Phase 2 study of bictegravir, Gilead's non-boosted, integrase inhibitor. The 48-week study compared bictegravir to dolutegravir, each given in combination with F/TAF, and the data will be presented at the Conference On Retroviruses and Opportunistic Infections in Seattle.

    隨著 Odefsey 和 Descovy 的成功推出,我們現在為 HIV 患者提供了三種不同的、重要的全新選擇。我們將繼續在 HIV 領域進行創新,下週,我們將發表吉利德公司非增強型整合酶抑制劑比克替拉韋的 II 期研究數據。這項為期 48 週的研究比較了比克替拉韋和多替拉韋,兩者均與 F/TAF 聯合使用,研究數據將在西雅圖舉行的逆轉錄病毒和機會性感染會議上公佈。

  • The detailed results are embargoed at this time and we look forward to sharing the data with you as soon as we are allowed to do so. CROI is one of the most important meetings for HIV research and this year's meeting gives us an opportunity to present promising data from multiple research and clinical programs aimed at addressing the unmet needs of people living with HIV.

    詳細結果目前暫不公佈,我們期待在獲準公佈後儘快與您分享數據。CROI 是 HIV 研究領域最重要的會議之一,今年的會議讓我們有機會展示來自多個研究和臨床項目的有希望的數據,這些項目旨在滿足 HIV 感染者未被滿足的需求。

  • Included in the conference will be data from our programs on novel, long-acting agents, next-generation nucleotides for highly treatment-experienced patients and new data on our efforts to cure HIV patients. Gilead remains firmly committed to R&D focus on improving the lives of people with HIV.

    會議內容將包括我們關於新型長效藥物、用於治療經驗豐富的患者的下一代核苷酸以及我們治癒 HIV 患者的最新研究數據。吉利德始終堅定致力於研發,並專注於改善愛滋病毒感染者的生活。

  • Similar to HIV, we have revolutionized the treatment of viral hepatitis by providing medicines to cure chronic hepatitis C infections or managing chronic hepatitis B more effectively. Gilead's HCV therapies have a cure rate of between 95% and 99% regardless of Genotype, with fewer side effects and [regardless] of treatment times in prior treatments.

    與愛滋病毒類似,我們透過提供藥物來治癒慢性C型肝炎感染或更有效地控制慢性B型肝炎,徹底改變了病毒性肝炎的治療方法。吉利德的C型肝炎療法治癒率在 95% 到 99% 之間,且不受基因型影響,副作用較少,也不受先前治療時間長短的影響。

  • When we launched [Devalty] in late 2013, most of the patients had quite advanced liver disease and had been under care for many years. In nearly every country, the healthcare system expanded to unprecedented levels in order to care for the sicker patients as time was running out for many of them. Following this great success, patients seeking care today have a quite different profile.

    2013 年底我們推出 [Devalty] 時,大多數患者都患有相當嚴重的肝病,並且已經接受治療多年。幾乎每個國家都擴大了醫療體系,以照顧那些生命垂危的重症患者,因為許多患者的生存時間已經不多了。繼這一巨大成功之後,如今尋求治療的患者群體呈現出截然不同的特徵。

  • These patients have less advanced disease and require more time for work-ups prior to initiating treatment. Additionally, many co-morbidities or other issues that may affect treatment until result. As a result, our analysis of the situation predicts that fewer people will be treated in 2017 then in 2016 in the United States, Europe and Japan. These healthcare systems each see a lower spending in this category as a result.

    這些患者的病情較輕,在開始治療前需要更多時間檢查。此外,還有許多合併症或其他問題可能會影響治療效果。因此,我們對情勢的分析預測,2017 年美國、歐洲和日本接受治療的人數將比 2016 年減少。因此,這些醫療保健系統在該類別上的支出均有所下降。

  • We continue to work to ensure patients have access to HCV medications. For example, in the US, we've offered very generous rebates and discounts to various entities that reimburse for prescription drugs, contrary to the sometime misleading headlines citing our list pricing. In 2016 in the US, the volume weighted average price for Harvoni was reduced to less than $15,000 per bottle, inclusive of discounts or rebates. This average is skewed by a significant discount provided to the Medicaid and the VA in the 340B Program. For example, our average price per bottle for Medicaid is less than $10,000 for states that are opening up access to all patients. Prices for 2017 are expected to be similar.

    我們將繼續努力確保患者能夠獲得丙型肝炎藥物。例如,在美國,我們向各種報銷處方藥的機構提供了非常慷慨的回扣和折扣,這與一些引用我們標價的誤導性標題相反。2016 年,在美國,哈沃尼葡萄酒的銷售加權平均價格降至每瓶 15,000 美元以下,其中包括折扣或回饋。由於 340B 計劃向醫療補助計劃和退伍軍人事務部提供了大幅折扣,因此該平均值存在偏差。例如,對於向所有患者開放醫療補助的州,我們每瓶藥的平均價格低於 10,000 美元。預計2017年的價格將與此類似。

  • Despite the fact that prices of direct acting antiviral HCV medications had never been lower; getting payer access to these therapies is often an onerous process for patients and doctors. With the declining rates of patient starts, it is our hope that progress can be made by next year to simplify the access process for patients with less advanced liver disease. Patients who are early in their disease have the highest cure rates and often require only eight weeks of treatment, resulting in an even lower cost per cure.

    儘管直接作用的抗病毒丙型肝炎藥物的價格從未如此低廉;但對於患者和醫生來說,獲得這些療法的支付方支持通常是一個繁瑣的過程。隨著患者入院率的下降,我們希望明年能取得進展,簡化病情較輕的肝病患者的入院流程。疾病早期患者的治癒率最高,通常只需要八週的治療,因此每次治癒的成本較低。

  • There's still one unmet medical need in HCV treatment: patients who have failed direct-acting antivirals. Gilead filed a New Drug Application for a single-tablet regimen of SOF/VEL/VOX in December and the FDA granted priority review status with a set target review date of August 8, 2017. A Market Authorization Application in the EU was filed in January. If approved, SOF/VEL/VOX will be the first STR for HCV patients who have failed in prior treatments. Our NASH program continues to advance. We believe that NASH is a growing unmet need around the world, with data suggesting that perhaps 3 million people in the United States have advanced NASH with fibrosis. We are committing significant R&D resources towards this public health problem. At AASLD in November, we presented positive Phase 2 data on Selonsertib, showing both any improvement in fibrosis scores and a decrease in progression of disease after only 24 weeks of treatment. Selonsertib is a first-in-class ASK1 inhibitor and we are pleased with the efficacy seen at a relatively low once-daily dose.

    丙型肝炎治療領域仍有一個尚未滿足的醫療需求:即對直接抗病毒藥物治療無效的患者。吉利德公司於 12 月提交了 SOF/VEL/VOX 單片療法的新藥申請,FDA 授予其優先審查資格,並將目標審查日期定為 2017 年 8 月 8 日。1月已向歐盟提交市場准入申請。如果獲得批准,SOF/VEL/VOX 將成為第一個用於治療先前治療失敗的 HCV 患者的單株抗體藥物。我們的 NASH 計畫持續取得進展。我們認為 NASH 是世界各地日益增長的未滿足需求,數據顯示,美國可能有 300 萬人患有伴有纖維化的晚期 NASH。我們正投入大量研發資源來解決這個公共衛生問題。在 11 月的 AASLD 會議上,我們公佈了 Selonsertib 的積極 2 期數據,結果顯示,僅經過 24 週的治療,纖維化評分就有所改善,疾病進展也有所減緩。Selonsertib 是一種首創的 ASK1 抑制劑,我們對它以相對較低的每日一次劑量所展現的療效感到滿意。

  • Based on these promising results, we consulted regulatory agencies and initiated two Phase 3 studies of Selonsertib. One is in patients with F3, and one is in patients with F4 fibrosis scores. Patients with F3 and F4 fibrosis have the greatest medical need and impose the highest cost on healthcare payers. In addition, patients with NASH and F4 fibrosis have a median life expectancy of only five years.

    基於這些令人鼓舞的結果,我們諮詢了監管機構,並啟動了 Selonsertib 的兩項 3 期研究。其中一例為纖維化評分 F3 的患者,另一例為纖維化評分 F4 的患者。F3 和 F4 纖維化患者的醫療需求最大,為醫療保健支付方帶來最高的成本。此外,患有 NASH 和 F4 纖維化的患者的平均壽命只有五年。

  • We are also continuing with two other promising agents in the treatment of NASH and other metabolic disease: GS-0976, an ACC inhibitor, and GS-9674, an FXR agonist. As these programs advance through this year, we may also begin to look at the combinations to determine if two mechanisms, one that hits the metabolic dysfunction of Hepatocyte and one that reverses fibrosis, can improve efficacy with an acceptable safety profile.

    我們也持續研究另外兩種有希望用於治療 NASH 和其他代謝疾病的藥物:GS-0976(一種 ACC 抑制劑)和 GS-9674(一種 FXR 激動劑)。隨著這些計畫在今年的推進,我們或許也會開始研究組合療法,以確定兩種機制(一種針對肝細胞代謝功能障礙,另一種逆轉纖維化)能否在可接受的安全性範圍內提高療效。

  • In the area of inflammation, Phase 3 studies of Filgotinib in rheumatoid arthritis, ulcerative colitis and Crohn's disease are now underway and enrolling. Filgotinib has a very large safety database of more than 1,400 patient years, and has proven to be well tolerated. With this once-daily dosing and safety profile, we'll continue to look at Filgotinib across a range of different inflammatory diseases where JAK1 activity is implicated. And we have plans to initiate up to six Phase 2 studies during the year.

    在發炎領域,Filgotinib 治療類風濕性關節炎、潰瘍性結腸炎和克隆氏症的 3 期研究目前正在進行中並招募患者。Filgotinib 擁有超過 1400 患者年的龐大安全性資料庫,並已被證明具有良好的耐受性。鑑於其每日一次的給藥方式和安全性,我們將繼續研究 Filgotinib 在 JAK1 活性相關的各種發炎性疾病中的應用。我們計劃在年內啟動多達六項二期臨床試驗。

  • 2017 marks Gilead's 30th anniversary. Over the past three decades, Gilead's many innovative products have helped transform HIV infection from a fatal and debilitating disease into a chronic manageable condition, giving individuals with HIV a chance to live out their lives. More than 10 million people are receiving a Gilead-based HIV regimen every day. We are proud of our ability to help HIV patients access their medications globally.

    2017年是基列國成立30週年。在過去的三十年裡,吉利德的眾多創新產品幫助將 HIV 感染從一種致命且使人衰弱的疾病轉變為一種可控的慢性疾病,使 HIV 感染者有機會度過餘生。每天有超過1000萬人接受基於吉利德公司的HIV治療方案。我們為能夠幫助全球愛滋病患者獲得藥物而感到自豪。

  • In the US for example, we work closely with public health systems to ensure access. In fact, Gilead has frozen prices to the federal and state funded AIDS Drug Assistance Program since 2008, and state Medicaid programs pay less for Truvada today than at launch in 2004. Gilead's commitment to these important safety net programs has allowed them to expand over the years, now providing coverage to slightly more than half the people living with HIV in the United States.

    例如,在美國,我們與公共衛生系統密切合作,以確保醫療服務。事實上,自 2008 年以來,吉利德公司一直凍結聯邦和州政府資助的愛滋病藥物援助計畫的價格,而如今各州醫療補助計畫為 Truvada 支付的費用比 2004 年上市時要少。吉利德對這些重要的社會安全計畫的承諾,使得這些計畫得以在過去幾年中不斷擴展,現在為美國超過一半的愛滋病毒感染者提供醫療保障。

  • Over the last several months, I've had the opportunity to talk with public and health policy experts, healthcare providers and industry leaders about the various access that remains, and how we can collectively help address them. We, at Gilead, will continue to seek solutions so that today's medicines can be accessed by all the people who need them, while supporting the innovative needs for fighting tomorrow's public health problems.

    在過去的幾個月裡,我有機會與公共衛生政策專家、醫療保健提供者和產業領袖探討了仍然存在的各種取得途徑問題,以及我們如何共同努力解決這些問題。吉利德將繼續尋求解決方案,使所有需要藥物的人都能獲得今天的藥物,同時支持應對未來公共衛生問題的創新需求。

  • Finally, we will continue to maintain a strong operating and financial discipline, and focus our efforts in 2017 on continuing to build out our pipeline, aggressively progressing internal programs, and pursuing partnerships or acquisitions that are the right strategic fit with our Company. I'm confident in the future of Gilead and I'm looking forward to sharing with you the many accompaniments across this organization in 2017.

    最後,我們將繼續保持嚴格的營運和財務紀律,並將 2017 年的工作重點放在繼續拓展我們的產品線、積極推進內部專案以及尋求與公司策略契合的合作夥伴關係或收購。我對吉利德的未來充滿信心,並期待在 2017 年與大家分享該組織在各個方面所取得的成就。

  • I would like to take this opportunity to thank our employees. It is because of your commitment and drive that we are able to help millions of people to live healthier, more fulfilled lives. Thank you for your time and let's now open the call for questions. Operator?

    我想藉此機會感謝我們的員工。正是由於你們的奉獻和努力,我們才能幫助數百萬人過著更健康、更充實的生活。感謝您抽出時間,現在我們開始提問環節。操作員?

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Geoff Meacham, Barclays.

    巴克萊銀行的傑夫·米查姆。

  • - Analyst

    - Analyst

  • Great. Afternoon, guys. Thanks for the question. So, John, when I look at the year-on-year trends on hep C over last year, they're obviously weaker as you progress through the year. What I find impressive though is your cash flow generation remains somewhat stable. So I know on this call you'll get a number of deal questions, but I wanted to get a sense as to how much your cash flow informs the urgency for deals versus other metrics, such as operational synergy or valuation? And then a real quick one for Kevin. Just wanted to know the payer attitudes towards PrEP in the US and Europe and how they've changed? Thanks, guys.

    偉大的。下午好,各位。謝謝你的提問。約翰,當我查看去年丙肝的同比趨勢時,很明顯,隨著時間的推移,丙肝的發生率呈下降趨勢。不過,讓我印象深刻的是,你們的現金流保持得相當穩定。我知道在這通電話中你會收到很多關於交易的問題,但我更想了解的是,現金流在多大程度上影響你對交易緊迫性的判斷,而其他指標,例如營運協同效應或估值,又會如何影響你的判斷?然後給凱文快速提一個問題。我想了解美國和歐洲的支付方對暴露前預防(PrEP)的態度以及這種態度發生了哪些變化?謝謝各位。

  • - President and CEO

    - President and CEO

  • Hey Geoff, thanks for the question. If you think about the different models and we think about our budget for 2017, we still have a very impressive net income and operating margin and importantly, cash flow out of it. In fact, it would rank at or above nearly every one of our comparable companies. So we still feel very good about the Company.

    嗨,傑夫,謝謝你的提問。如果考慮到不同的模型,再看看我們 2017 年的預算,我們仍然擁有非常可觀的淨收入和營業利潤率,更重要的是,還有可觀的現金流。事實上,它的排名幾乎與我們所有同類公司相同或更高。所以我們仍然對公司充滿信心。

  • We feel very good about our cash flow for the future. I think it's still for us a desire and a need to have a right strategic fit for the Company. That is the driver for why and when we do any mergers or acquisitions or partnerships, much more so than the need for cash flow, because we feel very comfortable about where we are.

    我們對未來的現金流非常有信心。我認為,對我們公司而言,找到合適的策略夥伴仍然是一種願望和需求。這才是我們進行任何併購或合作的真正原因和時機,遠比現金流的需求更重要,因為我們對目前的狀況感到非常滿意。

  • - COO

    - COO

  • Hey, Geoff. It's Kevin. Let me take the PrEP. Thank you for asking it. I just wanted to repeat that we now have deployed a small but very focused PrEP team around the country. It's very much in the urban areas. And we do hope that we can support PrEP education along the lines, as I said, of the likes of San Francisco.

    嘿,傑夫。是凱文。讓我服用PrEP。謝謝你的提問。我只想重申一下,我們現在已經在全國各地部署了一支規模雖小但目標明確的PrEP團隊。它主要位於城區。正如我剛才所說,我們希望能夠支持像舊金山這樣的地區進行 PrEP 教育。

  • Right now, there is fairly good payer coverage in the United States for PrEP. It's largely through the commercial payers and they see the benefit. So largely, the patient groups that are currently using PrEP now have good coverage. Obviously, we're going to take it into a wider audience, so we'll have to make sure that we get perhaps some of the public payers onboard with support for PrEP.

    目前,美國對 PrEP 的健保覆蓋範圍相當不錯。這主要透過商業保險公司實現,他們看到了其中的好處。因此,目前使用 PrEP 的患者群體總體上得到了良好的覆蓋。顯然,我們要把它推廣到更廣泛的受眾群體,所以我們必須確保能夠獲得一些公共支付者的支持,從而推廣 PrEP。

  • Generally in Europe, it's government reimbursed. A year ago, we had France give us coverage and we have about 3,000 patients now on the medication in France. And we're starting to see other governments come out. The UK came out with a statement fairly recently on providing support for PrEP. So we're seeing some momentum starting to build outside Europe.

    在歐洲,這筆費用通常由政府報銷。一年前,法國為我們提供藥品保險,目前法國約有 3,000 名患者正在服用這種藥物。我們開始看到其他國家的政府也站出來表態。英國最近發表了一份關於為PrEP提供支援的聲明。所以我們看到歐洲以外的地區也開始出現一些發展動能。

  • The other thing I would just very quickly say about PrEP that we see as an important signal of adoption is that we're seeing more persistency of treatment for the PrEP patient. In other words, they are getting repeated bottles month after month in some ways rather like an HIV patient. So that's encouraging that it's starting to become established and routinely used for its preventative benefits in patients.

    關於 PrEP,我還想快速補充一點,我們認為這是一個重要的普及訊號,那就是 PrEP 患者的治療堅持率越來越高。換句話說,他們每個月都會反覆收到瓶裝藥,從某種程度上來說,他們有點像愛滋病患。令人鼓舞的是,它正逐漸被確立並常規用於患者的預防保健。

  • - Analyst

    - Analyst

  • Thanks, guys.

    謝謝各位。

  • Operator

    Operator

  • Brian Abrahams, Jefferies.

    Brian Abrahams,傑富瑞集團。

  • - Analyst

    - Analyst

  • Thanks for taking my question and appreciate all the granularity around guidance. Just a question on the hep C guidance. What's the right way to think about the potential decline in new patient starts in the US versus Europe that you might anticipate this year? And to what extent might new competitive entrants impact price or share this year even before the traditional annual renegotiation of formularies? Might we look for that to maybe contribute more beyond that this year and into 2018?

    感謝您解答我的問題,也非常感謝您提供的詳盡指導。關於丙型肝炎指南,我有個問題。對於今年美國和歐洲新患者數量可能出現的下降趨勢,我們該如何正確看待?即使在傳統的年度藥品目錄重新談判之前,新的競爭者今年又會在多大程度上影響價格或市佔率呢?我們是否可以期待它在今年乃至 2018 年做出更大的貢獻?

  • - COO

    - COO

  • Brian, I'll probably ask Jim to help me a little bit with a very good question. You can see from slide 24, when we deliberately broke out the US, the EU5, Japan. There are very similar dynamics going on here. In fact, if you look deeper into the EU5, again, irrespective of the type of healthcare system, there is this decline going on.

    布萊恩,我可能會請吉姆幫我解答一個非常好的問題。從第 24 張投影片可以看出,我們刻意將美國、歐盟 5 國和日本單獨列出。這裡的情況與此非常相似。事實上,如果你深入了解歐盟五國,你會發現,無論醫療保健系統類型如何,都存在這種衰退現象。

  • It is more profound in Japan and I tried to describe that effect. So these are our best estimates, Brian. We've taken into account some of the trends we see through prescriptions. We've tried to listen to some of the public payers like the VA. The VA don't publish their data on treatment starts, so we just really got to sense how they're doing in terms of moving through their patients.

    這種影響在日本更為顯著,我試圖描述這種影響。布萊恩,這些是我們目前最好的估算。我們已經將一些從處方中觀察到的趨勢考慮在內。我們努力聽取了一些公共支付者的意見,例如退伍軍人事務部。退伍軍人事務部不公佈治療開始數據,所以我們只能憑感覺來判斷他們在治療病人方面做得如何。

  • We obviously also take judgments on the opening of access from a Medicare -- Medicaid point of view. It tends to be relatively slow. We have blocked together the competition, the share, and the treatment duration, bearing in mind that slide 23, that is total around Europe. So it takes into account all competitive dynamics. But perhaps, Jim, you may have one or two questions on how we think about this?

    我們顯然也會從聯邦醫療保險和醫療補助的角度對開放准入做出判斷。它的速度通常比較慢。我們已經將競爭、份額和治療持續時間放在一起考慮,同時考慮到第 23 張投影片,這是整個歐洲的情況。因此,它考慮到了所有競爭動態。吉姆,或許你對我們是如何看待這個問題有一兩個問題?

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • No, I would just reiterate what Kevin said that the biggest impact, of course, is patient starts. And that's what we're seeing. It's across all of the different segments in the US and really across all global markets. Whenever there is a competitive entrant, historically, there has been some level of magnitude. It varies by competition on both price and share.

    不,我只想重申凱文所說的,當然,最大的影響是耐心起步。這就是我們所看到的。它遍及美國所有不同的細分市場,實際上也遍及所有全球市場。從歷史上看,每當有競爭對手進入市場,都會產生一定規模的影響。價格和市場佔有率都會因競爭情況而異。

  • So that is factored in here. Again, there is multiple launches later this year. It's not just a competitor. We have a launch later this year. We don't expect formularies to change. That rarely happens with payers in the fourth quarter in the US. But all of this is taken into account in that bucket that you see on slide 23. And, but again, I can't say enough how much the primary driver is the dynamic we're seeing in patient starts.

    所以這一點已經考慮進去了。今年稍後還有多次新品發布。它不僅僅是競爭對手。我們計劃在今年稍後推出新品。我們預計配方不會改變。這種情況在美國第四季的支付方中很少發生。但所有這些都已考慮在內,您可以在第 23 張幻燈片上看到的那個桶中。而且,我再三強調,我們看到的患者發病率的動態變化是主要驅動因素。

  • - COO

    - COO

  • I'd also just add, Brian, we're still very, very confident in the profile of the two options that we have for hepatitis C. Harvoni is still a tremendous product. I would just add that it's about 50% now, the patients that are using eight weeks of Harvoni in Genotype 1. And as you've seen from the numbers, there's been tremendous uptake of Epclusa in the Genotype 2 and 3 patients.

    布萊恩,我還要補充一點,我們仍然對我們目前治療C型肝炎的兩種方案非常有信心。 Harvoni 仍然是一款非常優秀的產品。我還要補充一點,目前大約有 50% 的基因型 1 患者正在接受為期八週的 Harvoni 治療。正如您從數據中看到的,基因型 2 和 3 患者對 Epclusa 的接受度非常高。

  • - Analyst

    - Analyst

  • Very helpful. Thanks.

    很有幫助。謝謝。

  • Operator

    Operator

  • Robyn Karnauskas, Citigroup.

    Robyn Karnauskas,花旗集團。

  • - Analyst

    - Analyst

  • Thanks for taking my question. And thank you for all the color on the guidance. It's really helpful. I guess I think the question that I think a lot of people ask me is, you've bottled volume declining aggressively this year. And while you haven't given guidance beyond that, maybe help us think about, could this happen again next year? Is there anything that gives you comfort that we could see some stability in the patient volumes at least in the near term? Thanks.

    謝謝您回答我的問題。感謝您為指導原則提供的所有精彩內容。這真的很有幫助。我想很多人問我的問題是,你們今年的瓶裝酒銷量一直在急劇下降。雖然您沒有給更多指導,但或許可以幫我們思考一下,明年這種情況會不會再發生?有什麼跡象表明,至少在短期內,患者數量可能會保持穩定?謝謝。

  • - COO

    - COO

  • Thank you, Robyn, it's Kevin. Let me start. And maybe perhaps one or two of my colleagues might chip in here. This market's been full of surprises. It surprises on the way up, I think, Robyn, and it surprised us, in some ways, on these dynamics we see coming down the other side. So it's a kind of market that, in some ways, we take one year at a time. We're almost learning as we're going along.

    謝謝你,羅賓,我是凱文。我先開始。或許我的一兩位同事也會參與。這個市場充滿了驚喜。我認為,羅賓,上升的過程中總會遇到意想不到的情況,而從某種程度上來說,我們看到的這種下降過程中的動態也讓我們感到驚訝。所以,在某種程度上,我們只能一年一年來看這個市場。我們幾乎是在摸著石頭過河。

  • And we have tried, particularly Jim and myself, but we've tried every way to look at this market. We've probably --we have vast amounts of data, but it's always -- what we're always doing is forecasting with no backbone of chronic patients. So it's all about how you'd just judge the starts. So what we've got here in 2017 is, really, is our very, very best estimates. We've put them out there, and it's difficult for us really to go beyond this coming year.

    我們已經嘗試過,特別是吉姆和我,我們已經嘗試過各種方法來看待這個市場。我們可能擁有大量數據,但我們所做的總是——我們總是在沒有慢性病患者作為支撐的情況下進行預測。所以關鍵在於你如何評判開局。所以,我們在 2017 年所得到的,實際上是我們目前為止最好的估計。我們已經把計劃公佈出來了,但要展望明年之後的事情,我們真的很難。

  • - President and CEO

    - President and CEO

  • Robyn, I would say that our efforts and the efforts around us to try to open up access to the less severely ill patients will be instrumental in helping stabilize that, and that's one of our focuses for this year. In fact, even today, we saw some potential opening at one of the big plants. So all of this could be very useful in terms of stabilizing that number. And that will be a big focus of the Company this year.

    羅賓,我認為我們以及我們周圍的各方為使病情較輕的患者也能獲得醫療服務所做的努力,對於穩定病情至關重要,這也是我們今年的工作重點之一。事實上,即使在今天,我們還看到一家大型工廠有一些潛在的職缺。因此,所有這些對於穩定這個數字都非常有用。這將是公司今年的工作重點。

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • And maybe one final comment, Robyn, just would be that's why we continue to invest in direct-to-patient initiatives and disease awareness campaigns, because even if it is a slightly different profile of patients that's coming into care, they're ultimately all going to need treatment, or the vast majority are. So we need to continue to invest in that to ensure that there is a steady flow of patients for many years in the future.

    羅賓,或許我最後還要補充一點,這就是為什麼我們要繼續投資於直接面向患者的舉措和疾病意識宣傳活動,因為即使前來就診的患者群體略有不同,他們最終都需要治療,或者說絕大多數患者都需要治療。因此,我們需要繼續加大投入,以確保未來多年有穩定的病患來源。

  • - COO

    - COO

  • As you say, Jim, it's sort of a different patient presenting, and it's a longer journey.

    正如你所說,吉姆,這有點像是另一種類型的病人,而且治療過程也更長。

  • - Analyst

    - Analyst

  • Great. Thank you.

    偉大的。謝謝。

  • Operator

    Operator

  • Geoffrey Porges, Leerink Partners.

    Geoffrey Porges,Leerink Partners。

  • - Analyst

    - Analyst

  • Thank you very much. Thanks for taking the question. My question is concerning the guidance. It looks as though, back of the envelope, you're guiding for operating margins to be down by 700 or 800 basis points and tax rate up by 600 or 700 basis points. And so we go back to the question about looking ahead.

    非常感謝。感謝您回答這個問題。我的問題與指導意見有關。粗略估計,你們預計營業利潤率將下降 700 或 800 個基點,稅率將上升 600 或 700 個基點。所以我們又回到了展望未來的問題。

  • First, if you do a deal, Robin, is there space in that R&D guidance for additional R&D investment in a deal? Or would that be incremental to your current guidance? And then secondly, to the extent that there's variability principally around HCV, is that the basis for the trend in the tax rate guidance? And should we extrapolate that if we believe that the trend will continue? Where might the tax rate guidance end up if you were straight HIV and the rest of the portfolio?

    羅賓,首先,如果你達成了一項交易,研發指導中是否有空間用於該交易中的額外研發投資?或者說,這算是您現有指引的補充?其次,如果主要圍繞 HCV 存在差異,那麼這是否是稅率指導趨勢的基礎?如果我們認為這種趨勢會持續下去,我們是否應該將此推論下去?如果你的投資組合中只有愛滋病毒感染者,那麼稅率指導最終會如何改變?

  • - EVP and CFO

    - EVP and CFO

  • Sure, Geoff. So thanks for the questions. I mean, to your first question regarding R&D expense, yes, there is opportunity to do some deal and add incremental R&D expense to get us back to levels commensurate with last year that we've thought about. But more importantly than just the year, we've kind of thought about that relative to some of the actions we've looked at or thought about relative to our overall portfolio and our allocation across the various therapeutic areas that we support.

    當然可以,傑夫。謝謝大家的提問。我的意思是,對於你提出的第一個關於研發費用的問題,是的,有機會達成一些交易,增加研發費用,使我們恢復到我們設想的去年水準。但更重要的是,除了這一年之外,我們還考慮了與我們整體投資組合以及我們在所支持的各個治療領域的分配相關的一些行動。

  • So I'm not going sit here and guarantee that we wouldn't increase R&D expense. We will, to do the right thing and get new product [in the acquisition market], but there is some opportunity there to absorb some of that. And relative to tax rate, yes, when we started with hep C, we kind of gave these ratios which don't necessarily work on the way down.

    所以我不會坐在這裡保證我們不會增加研發費用。我們會做正確的事,並在收購市場中獲得新產品,但那裡也存在一些機會來吸收一部分。相對於稅率而言,是的,當我們開始研究C型肝炎時,我們給出了一些比率,但這些比率在下降的過程中不一定適用。

  • But I think one of the clear drivers with the delta in tax rate here is the fact that, as outlined in our guidance slide, a lot of the growth in HIV is coming from the US. So you're seeing more of our revenues be US-driven, which have a higher tax rate as well as less hep C, which, again, takes the tax rate up. So it's a balance, again, highly dependent on patient starts which is the primary driver across things. So if you see more patient starts and higher hep C revenue, you'd see us on the lower end of tax guidance.

    但我認為,稅率差異的一個明顯驅動因素是,正如我們在指導幻燈片中概述的那樣,愛滋病毒感染病例的大量增長來自美國。所以你會發現,我們的收入比較來自美國,而美國的稅率較高,C肝病例也較少,這又推高了稅率。所以這又是一個平衡問題,很大程度上取決於患者的啟動情況,這是所有事情的主要驅動因素。因此,如果患者數量增加,丙肝收入提高,我們的稅收指導就會處於較低水平。

  • - Analyst

    - Analyst

  • Okay. Thank you very much.

    好的。非常感謝。

  • Operator

    Operator

  • Mark Schoenebaum, Evercore ISI.

    Mark Schoenebaum,Evercore ISI。

  • - Analyst

    - Analyst

  • Thanks for taking the question. Thanks to Sung for all the helping my team while I was out. John, good to hear your voice. So let me ask you a deal question, maybe a little different way, if you don't mind. But -- and, John, this is a question I don't expect a yes or no. I expect you to kind of just riff on it. When you look at Gilead, can you take the revenue base in 2016 as a starting point? And do you believe that you could grow that revenue base by 2018 without an acquisition of external assets?

    感謝您回答這個問題。感謝Sung在我不在的時候對我的團隊的幫助。約翰,很高興聽到你的聲音。那麼,請容許我換個方式問您一個關於交易的問題,如果您不介意的話。但是──約翰,這個問題我並不指望得到「是」或「否」的答案。我希望你能即興發揮。以吉利德為例,能否以 2016 年的營收為起點進行分析?您認為在不收購外部資產的情況下,您能夠在 2018 年實現收入成長嗎?

  • And then the second part of that question is, your leverage ratio right now, at least on 2016, according to your slide deck, I think is 1.4. I know your EBITDA next year will be a little lower, so maybe that's 1.6 or something now. But any kind of thoughts, Robin or John, on like where that could go if you saw the right opportunity? Thanks a lot. I really appreciate it.

    那麼問題的第二部分是,根據你的投影片,至少在 2016 年,你的槓桿率應該是 1.4。我知道你明年的 EBITDA 會略低一些,所以現在可能是 1.6 左右。羅賓或約翰,你們有沒有想過,如果遇到合適的機會,這件事會如何發展?多謝。我非常感謝。

  • - President and CEO

    - President and CEO

  • First of all, Mark, it's really nice to hear your voice and we're glad to have you back

    首先,馬克,很高興聽到你的聲音,我們很高興你回來了。

  • - Analyst

    - Analyst

  • Thanks, John.

    謝謝你,約翰。

  • - President and CEO

    - President and CEO

  • Maybe less there now that you've asked a hard question. (laughter) As I understand it, what you're asking is, if you take 20 -- if you take the, say, circa $30 billion we had in 2016, can we do an acquisition that would grow off of that basis?

    你問了一個棘手的問題,也許現在你的感受會減輕一些。(笑聲)據我理解,你的問題是,如果我們拿出 200 億美元——比如說,如果我們拿出 2016 年擁有的大約 300 億美元,我們能否進行一次收購,並在此基礎上實現增長?

  • - Analyst

    - Analyst

  • No, could you grow the Company without an acquisition?

    不,你能在不收購的情況下發展公司嗎?

  • - President and CEO

    - President and CEO

  • Without an acquisition.

    無需收購。

  • - Analyst

    - Analyst

  • Was an acquisition a necessary requisite for revenue growth of 2016 levels over the next year or two?

    收購是否是未來一兩年內 2016 年營收成長水準的必要條件?

  • - President and CEO

    - President and CEO

  • We don't have a lot of things launching over the next few years. If you think about it, we have bictegravir which will be filed later this year, launching into next year. We're very confident of our HIV franchise. That is going to be a good growth driver for us. We are facing some headwinds in 2018 and beyond on other patent expiries we'll have, including the US patent of -- for TDF. We'll also have patents on Letairis and the following year, Ranexa.

    未來幾年我們沒有太多新產品推出。仔細想想,我們還有比克替拉韋,它將在今年稍後提交申請,明年上市。我們對我們的愛滋病防治業務非常有信心。這將是我們公司良好的成長動力。2018 年及以後,我們將面臨一些不利因素,因為我們還有其他專利即將到期,包括 TDF 的美國專利。我們也將獲得 Letairis 的專利,明年也將獲得 Ranexa 的專利。

  • So that puts some downward pressure on that non-HCV revenue base and so that makes it challenging for us to grow without some sort of acquisition in those areas. I'm not going to say exactly when that would pick up again. It will depend a little bit on where HCV stabilizes and it will depend quite a bit on the uptake of bictegravir, which as we keep pointing out, we're very excited to be able to share the data with you and hopefully, you'll share our enthusiasm for how this can transform the HIV market going forward.

    因此,這會對非C型肝炎病毒(HCV)收入基礎造成一定的下行壓力,因此,如果我們不在這些領域進行某種收購,就很難實現成長。我不會具體說什麼時候會再次恢復正常。這在一定程度上取決於丙型肝炎病毒的穩定情況,很大程度上取決於比克替拉韋的普及程度。正如我們一直強調的,我們非常高興能夠與您分享這些數據,並希望您能和我們一樣,對這項技術未來如何改變愛滋病毒市場充滿熱情。

  • - EVP and CFO

    - EVP and CFO

  • Mark I'll chime in on your debt to EBITDA question. I mean, I think we've been fairly thoughtful, particularly dealing with the rating agencies and in thinking about debt levels that we feel very comfortable that we can support acquisitions and increase our debt to EBITDA, most importantly, because given our cash flows, which we expect to continue for a very long time, we can easily delever over time with our existing therapeutic area franchises.

    馬克,關於你的債務與 EBITDA 比率的問題,我來說兩句話。我的意思是,我認為我們一直都相當謹慎,尤其是在與評級機構打交道以及考慮債務水平方面,我們感到非常有信心能夠支持收購併提高我們的債務與 EBITDA 比率,最重要的是,鑑於我們預計會持續很長時間的現金流,我們可以利用我們現有的治療領域特許經營權,隨著時間的推移輕鬆地降低槓桿率。

  • And this is totally exclusive of any potential tax changes, or particularly if there were repatriation. That would make all that even simpler. So we feel comfortable that on a from a asset standpoint that we could support any type of acquisition that we'd need to do to support Gilead's growth.

    而且這完全不包括任何潛在的稅收變化,特別是如果存在資金匯回的情況。那樣一來,一切都會變得更簡單。因此,從資產角度來看,我們有信心能夠支持吉利德發展所需的任何類型的收購。

  • - Analyst

    - Analyst

  • Thanks, Robin. Good to hear your voice, too.

    謝謝你,羅賓。很高興聽到你的聲音。

  • - EVP and CFO

    - EVP and CFO

  • You, too.

    你也是。

  • Operator

    Operator

  • Matthew Harrison, Morgan Stanley.

    馬修·哈里森,摩根士丹利。

  • - Analyst

    - Analyst

  • Good afternoon, everybody. Thanks for taking the questions. I guess I wanted to ask relative to some of your projections for this year and relative to guidance, instead of talking about where you can see further compression but where you might be able to see some upside? So I guess as you think about the projections you've made across HCV patient starts, how your HIV business performs or even some pipeline assets, where might you think about are sort of maybe potential upside SKUs in some of those projections? Thanks.

    大家下午好。謝謝您回答問題。我想問的是,相對於你們今年的一些預測和指引,而不是討論你們認為哪些方面可能會進一步壓縮,哪些方面可能會有一些上漲空間?所以,我想當你考慮到你對 HCV 患者起始治療、HIV 業務表現,甚至是某些在研產品所做的預測時,你會想到哪些 SKU 在這些預測中可能存在潛在的成長空間?謝謝。

  • - COO

    - COO

  • Matthew, let me make a start and again, you'll get some other views from around the table. I do want to go back to HIV. It's going really, really well. I mean, if you look at our results, year on year, we were up 17% in HIV and other antivirals and adding nearly $2 billion of revenues to the Company. Now a large part of that came from the US, and as you see from slide 22, we are predicting anywhere between $0.9 billion and $1.2 billion of growth from the US.

    馬修,讓我先開口,之後你還會聽到桌上其他人的意見。我確實想回到愛滋病研究領域。一切進展得非常順利。我的意思是,如果你看看我們的業績,與去年相比,我們在 HIV 和其他抗病毒藥物方面增長了 17%,為公司增加了近 20 億美元的收入。其中很大一部分來自美國,正如你從第 22 張投影片中看到的那樣,我們預測美國將帶來 9 億美元到 12 億美元的成長。

  • I don't know whether you picked up on my comment, but we already have 37% of treated HIV, Gilead-treated HIV patients on tap, which, in a year, is really a remarkable achievement. And it's our intention that we continue that growth and that momentum for Genvoya. So I really want to emphasize that. Yes, we have an interesting dynamic, as John pointed out, in Europe coming up with the loss of the TDF patent in July.

    我不知道你是否注意到我的評論,但我們已經有 37% 的 HIV 患者接受了吉利德公司的治療,這在一年內確實是一項了不起的成就。我們的目標是讓 Genvoya 繼續保持這種成長勢頭。所以我真的想強調這一點。是的,正如約翰所指出的那樣,歐洲出現了有趣的動態,因為TDF專利在7月失效了。

  • But I have to say that Europe is a kind of a mosaic of countries at different points in the TAF launch. So we'll just have to see how that event comes through. Now in terms of HCV, we would like to see a lot more access in Medicaid states, but that has been slow. We would certainly like to see access way improving, which we think a lot of patients could be cured.

    但我必須說,歐洲就像是 TAF 啟動不同階段的各國的馬賽克。所以,我們只能拭目以待,看看這件事最終會如何發展。就丙型肝炎而言,我們希望在醫療補助州看到更多的人獲得治療,但這進展緩慢。我們當然希望看到就醫途徑得到改善,我們認為許多患者可以因此得到治癒。

  • And we talk a lot to our government affairs team about that. Fibrosis scores are now, in some ways, opened in Europe. We still have some challenges around Southern Europe, Italy and Spain, but generally, that's not a barrier. Geographically, I think we're doing well around the world. We are thinking about a small build-out in China for the private market, but that really would be a 2018 and beyond effect.

    我們經常和政府事務團隊討論這個問題。在某些方面,歐洲的纖維化評分標準現在已經公開。我們在南歐、義大利和西班牙仍然面臨一些挑戰,但總的來說,這並不是障礙。從地理位置上看,我認為我們在世界各地都發展得很好。我們正在考慮在中國面向私人市場進行小規模建設,但這真的要到 2018 年及以後才會產生影響。

  • So what we have today, I think, is a really thriving HIV business. And as John has said, we are excited about bictegravir and we've got these interesting dynamics around HCV. And I concur entirely with Jim. We're going to continue to support HCV with a great deal of enthusiasm because there are still a lot of affected patients, and we'd like to bring them into care. And we have such an efficient operating model that we can do that.

    所以我認為,我們今天看到的是一個非常蓬勃發展的愛滋病產業。正如約翰所說,我們對比克替拉韋感到興奮,我們對丙型肝炎病毒(HCV)的研究進展非常感興趣。我完全同意吉姆的觀點。我們將繼續熱情地支持C型肝炎防治工作,因為仍有許多患者受到影響,我們希望讓他們得到治療。我們擁有如此高效的營運模式,所以能夠做到這一點。

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • I would agree, Kevin. And just maybe one, to build on one thing you said around PrEP earlier. As Kevin has said, we already have 110,000 patients on PrEP. Nearly half as -- twice that many have ever been exposed, and again, that's before what Kevin had mentioned, the deployment of a 40 person prevention specialist team. And some very targeted direct-to-patient and direct-to-provider advertising that we're going to do.

    我同意,凱文。或許還有一點,可以補充你之前提到的關於PrEP的那部分。正如凱文所說,我們已經有 11 萬名患者正在接受 PrEP 治療。曾經接觸過病毒的人數幾乎是現在的兩倍,而且,這還是在凱文提到的部署一支由 40 人組成的預防專家團隊之前的情況。我們還將開展一些非常有針對性的直接面向患者和直接面向醫療服務提供者的廣告活動。

  • I think as Kevin had mentioned, the vast majority of PrEP prescribing right now is in four or five cities where the awareness is very high. The area where HIV is, people are at highest risk of contracting HIV right now is in underserved, inner city areas. If you're an African-American MSM, your lifetime risk of HIV right now contracting it, is one in two.

    我認為正如凱文所提到的,目前絕大多數的 PrEP 處方都集中在四、五個城市,因為這些城市的人們對 PrEP 的認知度非常高。愛滋病毒目前流行區域內,感染愛滋病毒風險最高的族群是服務不足的城市中心地區。如果你是非裔美國男男性行為者,那麼你一生中感染愛滋病毒的風險目前為二分之一。

  • So we're going to have people in areas like, in epicenters like New Orleans, Baltimore, DC, Newark, Oakland, areas that we haven't been before. But also doing that through targeted advertising, and particularly trying to get at populations that don't engage in healthcare. So we'll be using social media and dating sites and Tumblr and Snapchat and things like that, that are much better -- are much more, I would say, likely media to reach this type of population.

    所以,我們將派人前往像新奧爾良、巴爾的摩、華盛頓特區、紐瓦克、奧克蘭這樣的疫情中心地區,這些都是我們從未去過的地方。但也可以透過定向廣告來實現這一點,尤其是要努力接觸那些不參與醫療保健的人。所以我們將使用社群媒體、約會網站、Tumblr、Snapchat 等等,這些都是更好的——我認為更有可能接觸到這類人群的媒體。

  • So we are bullish on, particularly in the US, the potential upside of PrEP as well. And again, there was an earlier question about the payers. I think the one thing that I believe payers are starting to see is if we can reduce the -- if we can prevent HIV from occurring, ultimately, that's going to bring down costs of treatment. And that's a lifetime cost of treatment. So again, that's one of the messages that we communicate as well when it comes to PrEP.

    因此,我們非常看好 PrEP 的潛在發展前景,尤其是在美國。之前也曾有人問過付款方的問題。我認為支付者開始意識到的一點是,如果我們能夠減少——如果我們能夠預防愛滋病毒的發生,最終將會降低治療成本。這是終身治療費用。所以,這也是我們在宣傳 PrEP 時想要傳達的訊息之一。

  • Operator

    Operator

  • Michael Yee, RBC Capital Markets.

    Michael Yee,加拿大皇家銀行資本市場。

  • - Analyst

    - Analyst

  • Good afternoon. Thanks for the question. In regards to 2017 guidance, I think it was quite a surprise what the numbers were. Is there some conservatism built in there? Is it kitchen sinking? Is it absolutely very realistically what you see? Maybe you could just characterize how you're thinking about it and whether you're trying to be conservative at all?

    午安.謝謝你的提問。關於 2017 年的業績指引,我認為最終的數字相當出乎意料。這其中是否蘊含著一些保守主義思想?這是廚房水槽嗎?你看到的景象真的非常逼真嗎?或許你可以簡單描述一下你的想法,以及你是否試圖採取保守的態度?

  • And then when I think about the patient numbers that are implied in there, which I think is on slide 28 or so, is there a cadence to the new patient starts across the US dropping from 230,000 to 160,000? Is that steadily across the area -- what is the one big thing I guess in 2017 that's different from 2016 as you built out that projection perhaps in your starts?

    然後,當我想到其中隱含的患者數量時(我認為是在第 28 張幻燈片左右),美國各地的新患者數量是否呈下降趨勢,從 23 萬下降到 16 萬?這種情況在整個地區是否持續存在? ——我想,2017 年與 2016 年相比,最大的不同是什麼?就像你在預測中提到的那樣,例如你的開局?

  • - EVP and CFO

    - EVP and CFO

  • Hi, Mike. It's Robin. I'll start and then I'll have the commercial team chime in. I wouldn't say that our philosophy around guidance has changed year to year. And I think what we've tried to do is to be very transparent, but we're cognizant of the fact that given what you've heard in our commentary, that we expect HCV market patient starts to go down.

    嗨,麥克。是羅賓。我先開始,然後讓商業團隊補充。我不會說我們關於指導的理念每年都在改變。我認為我們一直在努力做到非常透明,但我們也意​​識到,正如你們在我們的評論中聽到的那樣,我們預計丙型肝炎患者市場將開始下降。

  • The reality of it is, is exactly how that will happen and when is still very difficult for us to really hone in on, hence the wide variability in our HCV guidance relative to our non-HCV guidance where we do have much more predictability given that it's a chronic market. So I wouldn't say there's overly -- over-conservatism built in. I mean, there's always some conservatism built into guidance but I wouldn't characterize the way we've guided here to be different than we have in the past.

    現實情況是,我們仍然很難真正確定這種情況將如何發生以及何時發生,因此,與非丙型肝炎的指導意見相比,我們對丙型肝炎的指導意見存在很大的差異,因為丙型肝炎是一個慢性病市場,我們對非丙型肝炎的指導意見具有更大的可預測性。所以我不會說其中有過度保守主義。我的意思是,指導方針中總是包含一些保守因素,但我不會說我們在這裡採取的指導方式與過去有所不同。

  • - COO

    - COO

  • Michael, just very quickly. I had a comment. Again, I said it earlier, we've used our best efforts. We've shared, I think, pretty much all our data that we have with you today. So we've really used our best efforts on trending, on the various payer buckets of patients. I would highlight on the slide that we've supplied on patient starts.

    邁克爾,就簡單說幾句。我有個意見。我之前已經說過,我們已經盡了最大的努力。我想,今天我們已經和大家分享了幾乎所有我們掌握的數據。因此,我們已經盡最大努力對不同付費患者群體進行趨勢分析。我想重點介紹一下我們提供的關於患者啟動的幻燈片。

  • There is the -- there is a call-out of the 20,000 patients that was the uplift in 2016. So in total, it was 231,000 patients but there was an uplift of 20,000. So whilst 2017 seems a big step down, it's not as great when you take into account the uplift that took place in 2016.

    2016 年,有 20,000 名患者獲得了提升。所以總共有 231,000 名患者,但增加了 20,000 名。所以,雖然 2017 年看起來是一個很大的倒退,但考慮到 2016 年的成長,情況並沒有那麼糟。

  • - Analyst

    - Analyst

  • Okay. Thank you.

    好的。謝謝。

  • Operator

    Operator

  • Cory Kasimov, JPMorgan.

    科里·卡西莫夫,摩根大通。

  • - Analyst

    - Analyst

  • Good afternoon, guys thanks for taking my question. So heading into CROI, can you remind us the design of the [F/TAF] study versus your ongoing Phase 3? Maybe how we should be thinking about this update next week? And in light of the decision to use a lower dose in Phase 3, I guess I'm just wondering how much that impacts the readthrough if it does, in any way? Thanks.

    下午好,各位,感謝你們回答我的問題。那麼,在進入 CROI 階段之前,您能否提醒我們 [F/TAF] 研究的設計與您正在進行的 3 期臨床試驗有何不同?或許我們該這樣考慮下週的更新?鑑於在 3 期臨床試驗中決定使用較低劑量,我想知道,如果會的話,這會對結果解讀產生多大影響?謝謝。

  • - EVP, R&D and Chief Scientific Officer

    - EVP, R&D and Chief Scientific Officer

  • Thanks, Cory, for the question. I thought this earnings call might end without ever anybody asking me a question. So thanks for the question. So the design of the study was very similar to Phase 3. It's dolutegravir versus bictegravir given with F/TAF.

    謝謝科里提出的這個問題。我原以為這次財報電話會議可能會在沒有人問我問題的情況下結束。謝謝你的提問。因此,研究的設計與第 3 期非常相似。研究對象為多替拉韋與比克替拉韋合併 F/TAF 治療的比較。

  • And our Phase 3 study is the same design but using the single TAF/F regimen instead of the individual component. And then the dose that was actually used for bictegravir is it gives you the same exposure as the Phase 2 dose. So the Phase 3 dose is the same exposure as the Phase 2 dose. There was some slight drug interaction when you co-formulated the bictegravir into a single TAF/F regimen.

    我們的 3 期研究採用相同的設計,但使用單一的 TAF/F 方案而不是單一成分。而實際使用的比克替拉韋劑量,其暴露量與第二期劑量相同。因此,第三階段的劑量與第二階段的劑量相同。將比克替拉韋與 TAF/F 合併配製時,出現了一些輕微的藥物交互作用。

  • Of course, by the way, the other Phase 3 study, there are four Phase 3 studies. The other controlled Phase 3 study, a single TAF/F regimen versus single TAF/F regimen, which is bictegravir F/TAF versus Triumeq. And then there are two switch studies.

    當然,順便提一下,還有另一項 3 期研究,總共有四項 3 期研究。另一項受控的 3 期研究,是單一 TAF/F 方案與單一 TAF/F 方案的比較,即比克替拉韋 F/TAF 與 Triumeq 的比較。另外還有兩項開關研究。

  • - Analyst

    - Analyst

  • Thank you, Norbert.

    謝謝你,諾伯特。

  • Operator

    Operator

  • Alethia Young, Credit Suisse.

    Alethia Young,瑞士信貸。

  • - Analyst

    - Analyst

  • Thanks for taking my question. I guess maybe just going to HIV and talking a little bit about the dynamics that may change over Europe. I saw that you included it in the guidance. That was helpful. But one, will the generic switches come from new starts or switches in HIV when you think about some of the markets in Europe? And then also, like should we expect the slope to be kind of the same, or will it kind of further go down as we move through the years, you think? Thanks.

    謝謝您回答我的問題。我想或許可以談談愛滋病,以及歐洲各地可能發生的變化。我看到您已將其包含在指導原則中。那很有幫助。但是,考慮到歐洲的一些市場,通用名藥物的轉換是來自新的開始,還是來自 HIV 領域的轉換?還有,我們是不是應該預期斜率會保持不變,還是隨著時間的推移會進一步下降呢?謝謝。

  • - COO

    - COO

  • Alethia, it is Kevin. Generally, and this is a general statement, switches are the dynamic part of HIV. It doesn't matter whether it's the US or it's Europe. So generally, that's where the action is, if you like, in the HIV market.

    阿萊西亞,我是凱文。一般來說(這只是一個概括性的說法),開關是 HIV 的動態部分。無論是美國還是歐洲,都無關緊要。所以總的來說,如果你願意的話,這就是愛滋病毒市場的主要活動所在。

  • I do want to repeat my comment of earlier, Alethia, that we've got different countries at different stages of the TAF rollout. And that will have some impact on what happens when -- if and when we see generics start to enter the various countries, because of course, whilst we aggregate for our results and aggregate for our comments, Europe is this whole, whole series of different countries. We're getting tremendous uptake of TAF in the early launch markets.

    Alethia,我想重申我先前的評論,那就是不同國家在 TAF 推廣方面處於不同的階段。這將對仿製藥開始進入各個國家時(如果真的會進入的話)的情況產生一定影響,因為當然,雖然我們匯總結果並匯總評論,但歐洲是由一系列不同的國家組成的。TAF 在早期上市市場中獲得了巨大的成功。

  • I think you can see the chart we put in of Germany, which is just absolutely tremendous. Descovy as well, by the way, even better than Genvoya. We have a lot of separate components in Germany. It just happens to be less of a STR market. So Germany's going great. Spain's going great. I think Jim and I have very high hopes for TAF in France, which is just this past week.

    我想你們可以看到我們放出來的德國的圖表,那真是太棒了。順便一提,Descovy 也比 Genvoya 好用得多。我們在德國有很多獨立的零件。碰巧的是,這裡短租市場規模較小。德國現在發展得很好。西班牙現在發展得很好。我覺得吉姆和我都很期待上週在法國舉行的TAF展。

  • So I think you've got a little bit of a picture to paint, and we'll just have to see how that emerges around the event that we've highlighted and we've been realistic about that versus how TAF, in its various forms, is adopted.

    所以我覺得你已經大致描繪出了一幅圖景,我們只需要看看在我們強調的事件周圍,以及我們對此一直保持務實態度的情況下,TAF 以各種形式被採用的情況,這幅圖景會如何演變。

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • I agree, Kevin. And I would just add, just having been over there, that we're not seeing any delay, really, in any of the reviews of TAF right now. And again, I think that's important. The generic impact will largely be limited to the compounds coming off patent. So it'll be Viread, which is little used; Truvada, which is in the early launch markets, decreasingly used; and then ultimately, Atripla.

    我同意,凱文。我還要補充一點,我剛去過那裡,目前我們並沒有看到 TAF 的任何審查出現任何延誤。而且,我認為這一點很重要。仿製藥的影響將主要限於專利到期的化合物。所以,接下來會是使用較少的 Viread;在早期上市市場使用率逐漸下降的 Truvada;然後最終是 Atripla。

  • It will have less, if any, impact on Stribild and Complera and hardly any impact on the TAF products once they're listed. So that's the whole key that Kevin said was, we're at various stages of roll-out, but once we get those products listed, if it's a 2017 with dynamics moving in a couple different directions, but once we get beyond that and we have the full TAF launch, we see this as a very sustainable growth driver for the Company.

    它對 Stribild 和 Complera 的影響較小,甚至沒有影響,一旦 TAF 產品上市,對它們的影響也微乎其微。所以凱文說的關鍵在於,我們目前處於不同的推廣階段,但一旦這些產品上市,如果 2017 年的情況朝著幾個不同的方向發展,但一旦我們度過了那段時期,全面推出 TAF,我們認為這將是公司非常可持續的成長動力。

  • Operator

    Operator

  • Ying Huang, Bank of America Merrill Lynch.

    黃穎,美國銀行美林證券。

  • - Analyst

    - Analyst

  • Thanks for taking my question. A quick one for Robin. If I look at your midpoint for 2017 guidance for SG&A and R&D, SG&A is roughly flat, but R&D continues to go up. So 2017 is the year where your earnings will come down. I was wondering how much operating leverage you might have in terms of those items on P&L? And then maybe for Kevin on slide 23, if I take the midpoint of the $1.9 billion to $2.5 billion negative impact from increased competition, shorter duration and do the math, it's roughly 15% down from 2016 level potentially for pricing. Is that the right way to think about how pricing would trend in 2017? Thanks.

    謝謝您回答我的問題。給羅賓一個簡短的問題。如果我看一下您 2017 年銷售、管理及行政費用和研發費用的中點指引,銷售、管理及行政費用大致持平,但研發費用持續成長。所以2017年你的收入將會下降。我想知道就損益表上的這些項目而言,您可能擁有多大的經營槓桿?然後,對於第 23 頁幻燈片上的 Kevin 來說,如果我取競爭加劇、持續時間縮短帶來的 19 億美元至 25 億美元負面影響的中點,並進行計算,價格可能會比 2016 年的水平下降大約 15%。這種思考方式是否正確,可以預測2017年的價格走勢嗎?謝謝。

  • - EVP and CFO

    - EVP and CFO

  • It's Robin. I'll start with your first question. I think relative to the ranges, first, just the one thing I want to mention on SG&A is it's going up primarily because of the branded prescription drug fee. And even with HCV revenues going down, we ended up with an IRS credit in 2016. So the comparator makes it look like it's going up. Across the board, as I said and John mentioned, I think we remain operationally efficient and do have leverage.

    是羅賓。我先回答你的第一個問題。我認為相對於各個範圍而言,首先,關於銷售、一般及行政費用,我想提一點,它上漲主要是因為品牌處方藥費用上漲。即使 HCV 收入下降,我們在 2016 年最終還是獲得了美國國稅局的稅收抵免。所以比較器顯示它看起來像是在上升。總的來說,正如我所說,約翰也提到過,我認為我們仍然保持著高效的運營,並且確實擁有優勢。

  • I mean obviously, our operating margins have been very high, driven by our revenue. But we never really grew our Company to the rate that our revenues grew. So we do feel we have operational leverage. And even if you look at some of the things we're investing in, in 2016 in SG&A and R&D, they were done by other things we've chosen not to invest in. So we'll continue to be able to concurrently make the necessary trade-offs, absent M&A, we think to remain efficient and focus on operational excellence.

    我的意思是,很顯然,我們的營業利潤率一直很高,這主要歸功於我們的收入。但我們公司的發展速度始終沒有跟上營收成長的速度。因此,我們確實認為我們擁有營運優勢。即使你看看我們在 2016 年投資的一些項目,例如銷售、管理及行政費用和研發費用,這些投資都是透過其他我們選擇不投資的項目來實現的。因此,在沒有併購的情況下,我們將繼續能夠同時做出必要的權衡,以保持效率並專注於卓越營運。

  • - COO

    - COO

  • Hey, Ying. It's Kevin. Just to address your second question. I really do hope we've been helpful with slide 23 to break out both the starts and the three of the elements, which is pricing, market share and duration. We won't go any further on the latter bucket. We believe we've really put our foot forward and tried to be helpful.

    嘿,瑩。是凱文。我來回答你的第二個問題。我真心希望第 23 張投影片能對大家有幫助,它詳細分析了新創公司和三個要素,即定價、市場份額和持續時間。我們不再贅述後一種情況。我們相信我們已經盡力而為,並努力提供幫助。

  • But please bear in mind that slide 23 is the whole world of Gilead. There's Europe in there. There's Japan in there. There's the US in there. So it's a whole basket of multiple dynamics around competition and duration.

    但請記住,第 23 張投影片展現的是整個基列世界。裡面有歐洲的元素。裡面有日本的元素。裡面有美國的元素。所以,這涉及到圍繞競爭和持續時間的多種動態因素。

  • - President and CEO

    - President and CEO

  • And maybe just one last thing is, keep in mind that Epclusa has only launched at this point in Germany. So this takes into account a competitive marketplace. Epclusa is going to -- we expect reimbursement in the UK in the first half, the rest of the countries in the second half. And it takes into account competitive dynamics, which are share and pricing around that.

    最後還有一點要注意,Epclusa 目前只在德國推出。所以這考慮到了競爭激烈的市場環境。Epclusa 將會——我們預計上半年將在英國獲得報銷,下半年將在其他國家獲得報銷。它還考慮了競爭動態,即市場份額和定價。

  • - Analyst

    - Analyst

  • Got it. Thank you.

    知道了。謝謝。

  • Operator

    Operator

  • Phil Nadeau, Cowen and Company.

    Phil Nadeau,Cowen and Company。

  • - Analyst

    - Analyst

  • Good afternoon. Thanks for taking my question. Just a question on intermediate term competition. Two things that investors are debating is the impact of the doublets that are based on dolutegravir that we could see data from this year or early next as well as potentially the competition from AbbVie's new doublet regimen in HCV. How is management looking at those two potential threats? Thanks.

    午安.謝謝您回答我的問題。關於中期競爭的問題。投資人正在討論兩件事:一是基於多替拉韋的雙藥療法的影響(我們可能會在今年或明年初看到相關數據);二是艾伯維公司在C型肝炎治療領域推出的新雙藥療法可能帶來的競爭。管理階層如何看待這兩個潛在威脅?謝謝。

  • - EVP, R&D and Chief Scientific Officer

    - EVP, R&D and Chief Scientific Officer

  • Yes, Phil, so the first question about the doublet, keep in mind what we haven't seen here is the efficacy of the doublet in a whole spectrum of HIV patient populations, particularly those with high viral load. Those have been excluded until now. And until and unless we see that it is really useful across all viral load spectrum, it's really difficult to see what competition that will be. But having that said, if it is efficacious, and if it is dissimilar to triple -- the single tablet regimens, then it will be a competitor to ours.

    是的,菲爾,關於雙聯療法的第一個問題是,請記住,我們還沒有看到雙聯療法對整個 HIV 患者群體(特別是病毒載量高的 HIV 患者群體)的療效。這些先前一直被排除在外。除非我們看到它在所有病毒量範圍內都真正有效,否則很難看出它會構成怎樣的競爭。但話雖如此,如果它有效,並且與三聯療法(單片療法)不同,那麼它將成為我們的競爭對手。

  • - COO

    - COO

  • Hey, Phil, in terms of hepatitis C, difficult to ever know what a competitor does. From what we can see of the data, it is kind of a step-up in terms of competition. But I'd like to just repeat what I said earlier. We have a heck of an offering in Harvoni and Epclusa. We've maintained very, very healthy market shares to date, I think probably exceeding what many, many people thought we would do.

    嘿,菲爾,就丙型肝炎而言,很難知道競爭對手在做什麼。從我們目前掌握的數據來看,這在競爭方面算是一種提升。但我只想重複一下我之前說過的話。我們在 Harvoni 和 Epclusa 這兩個品牌中提供了非常棒的產品。到目前為止,我們一直保持著非常非常健康的市場份額,我認為這可能超過了許多人對我們的預期。

  • So we'll continue to be very active and believe that we have the best options. The contracts for the US are 12-month contracts for 2017, so probably largely are more a 2018 type of event.

    因此我們將繼續積極行動,並相信我們擁有最佳方案。美國的合約是 2017 年的 12 個月合約,因此很可能主要屬於 2018 年的事件。

  • Operator

    Operator

  • Josh Schimmer, Piper Jaffray.

    喬許希默,派珀賈弗雷。

  • - Analyst

    - Analyst

  • Thanks for taking my question. I'm very into the growth question but hopefully, you can start to wind that down. Roughly when do you expect to see at least stabilization of the bottom line? And if you can't answer that question, why do you think investors should have a favorable outlook on the Company? And then on the PrEP franchise, can you elaborate on your plans or strategy to convert that to Descovy and how much you think you can convert? Thank you.

    謝謝您回答我的問題。我非常關注成長問題,但希望你能開始逐步減少這方面的討論。您預計公司獲利何時才能至少趨於穩定?如果你無法回答這個問題,你為什麼認為投資人應該對公司持樂觀態度?關於 PrEP 產品線,您能否詳細說明您將其轉換為 Descovy 的計劃或策略,以及您認為可以轉換多少?謝謝。

  • - COO

    - COO

  • Hey, Josh. We're not hearing you too well. We had a little bit of interference so I hope we've got the questions. So the PrEP, the PrEP to Descovy, Norbert or Andrew, in terms the Phase 3 studies, perhaps you could comment on that and we'll come back to the other question.

    嘿,喬許。我們聽不太清楚你在說什麼。我們遇到了一些幹擾,所以我希望我們已經把問題都問完了。那麼,關於 PrEP,關於 Descovy、Norbert 或 Andrew 的 PrEP,就 3 期研究而言,您或許可以對此發表一些評論,我們稍後再回到另一個問題。

  • - EVP, Clinical Research and Development Operations

    - EVP, Clinical Research and Development Operations

  • Hi, Josh. It's Andrew Cheng speaking and I would say that for our Phase 3 trial right now, it's ongoing. We're in the middle of enrollment. So it's very difficult to address how easy it will be to convert them without knowing the results, quite honestly.

    嗨,喬希。我是Andrew Cheng,我想說的是,我們目前的3期臨床試驗正在進行中。我們正在招生。坦白說,在不知道結果的情況下,很難判斷轉化它們有多容易。

  • - EVP, R&D and Chief Scientific Officer

    - EVP, R&D and Chief Scientific Officer

  • And, Josh, in terms again, I think I'd come back to my earlier comments. We are taking one year at a time. I do hope, again, whilst you may not be satisfied with perhaps some numbers we've put out there, Josh, we really have put our best foot forward and given you all the data, which is as much as we know.

    還有,喬希,再說一遍,我想我還是會回到我之前的評論。我們一步一步來。喬希,我再次希望,雖然你可能對我們公佈的一些數據不太滿意,但我們真的已經盡了全力,並向你提供了我們所知的全部數據。

  • So we're almost as intrigued by this market as you are. And we're doing our very best to try and model it. And by putting out the 2017 numbers, we hope that is helpful. And 2018 is, it will be what it will be when we get there.

    所以,我們對這個市場的興趣幾乎和你們一樣濃厚。我們正在盡最大努力嘗試模擬它。我們希望透過公佈 2017 年的數據,能對大家有所幫助。至於2018年,到時候就知道了。

  • Operator

    Operator

  • Terence Flynn, Goldman Sachs.

    特倫斯·弗林,高盛集團。

  • - Analyst

    - Analyst

  • Hi. Thanks for taking the question. Maybe just a two-part on hep C. So, Kevin, can you tell us what new diagnoses were in 2016 and then what you're assuming for 2017? And then Express recently published their annual drug trend report. They're projecting hep C spend declines over 30% in 2018 and 2019. So maybe just help us think about, again, I know those aren't your numbers, but as we think about the outyears, what could be some of the drivers going into those assumptions? Thank you.

    你好。感謝您回答這個問題。或許可以分成兩部分來談談C型肝炎。凱文,你能告訴我們2016年的新確診病例數是多少嗎?你對2017年的情況又有什麼預測呢?然後,《快報》最近發布了年度藥物趨勢報告。他們預測,2018 年和 2019 年C肝支出將下降 30% 以上。所以,或許您可以幫我們思考一下,我知道這些數字不是您的,但是當我們考慮未來幾年時,這些假設背後的驅動因素可能有哪些?謝謝。

  • - COO

    - COO

  • Hey, Terence. I'll take the first part of your question. If you look at slide 41 in our deck, it has the new diagnoses out there for you. We don't right now have 2016. It's always basically a database that's one year in arrears. So we do the best we can. This is the most up-to-date data that we have and we've now given to you.

    嘿,特倫斯。我來回答你問題的第一部分。如果您查看我們簡報中的第 41 頁,其中列出了最新的診斷結果。我們現在還沒有2016年的數據。它基本上總是一個資料滯後一年的資料庫。所以我們只能盡力而為。這是我們掌握的最新數據,現在已提供給您。

  • I would point out one thing on slide 43. Just like we're seeing healthier patients to be treated are being treated, you can see that there's basically less fibrosis in the presenting patients. So again, around this theme of patients essentially are coming forward who just don't quite have the urgency that had been previously. Jim?

    我想指出第 43 張投影片上的一點。正如我們看到接受治療的患者身體狀況越來越好一樣,你也可以看出,前來就診的患者體內纖維化程度基本上較低。所以,再次強調,患者們雖然出現了,但他們的病情並沒有以前那麼緊急。吉姆?

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • And then regarding ESI, I think it's probably a combination. I can't speak directly for them, but what I would hypothesize would be, you're probably aware that they did add Harvoni to the national formulary, so they now have an eight-week option, which is one of the best ways to reduce costs in HCV that they didn't have when they had the Viekira Pak as their sole option. So that's playing a role in what they're looking at over the next couple of years. But again, other than that, it's patient starts and their ability to project beyond 2017 is probably similar to ours. So it's challenging. And we're confident in 2017 and those are the drivers.

    至於 ESI,我認為可能是多種因素共同作用的結果。我不能直接代表他們發言,但我推測,您可能已經知道,他們確實將 Harvoni 添加到了國家處方集中,所以他們現在有了一個為期八週的選擇,這是降低丙型肝炎治療成本的最佳方法之一,而當他們只有 Viekira Pak 作為唯一選擇時,他們並沒有這種選擇。所以,這會對他們未來幾年的關注方向產生影響。但除此之外,他們的病人開始行動,而且他們預測 2017 年以後的能力可能與我們類似。所以這很有挑戰性。我們對 2017 年充滿信心,這些就是驅動因素。

  • Operator

    Operator

  • Ian Somaiya, BMO Capital.

    Ian Somaiya,BMO Capital。

  • - Analyst

    - Analyst

  • Thanks. Two questions. I'm not going pretend it's two parts. On bictegravir, just given the excitement related to the data and obviously, the opportunity that you've spoken to before, just give us a sense for what impact it will have on the rest of your HIV portfolio. And ultimately, should we expect you to regain some of the share that you've lost to the product offerings from ViiV? And unrelated question, but previously you've stated an unwillingness to compete on price in hep C. Would product offerings be more similar? Is that still the Company position?

    謝謝。兩個問題。我不會假裝它是兩個部分。關於比克替拉韋,鑑於相關數據帶來的興奮,以及您之前談到的機會,請您談談它將對您其他 HIV 治療產品組合產生什麼影響。最後,我們是否應該期待您能重新奪回一些因 ViiV 的產品而失去的市場份額?還有一個不相關的問題,但您之前曾表示不願在丙肝領域進行價格競爭。那麼產品組合是否會更相似呢?這是公司目前的立場嗎?

  • - COO

    - COO

  • So, Ian, I'll take the HIV question first. Part of the success of bictegravir is based on the success of Genvoya. And this 37% already of treated patients is terrific. And that bodes very, very well for TAF bictegravir. So what we like about this is, is that we are building, once again, the HIV franchise for Gilead. So we'll have a terrific Genvoya part of this and we believe we'll also have a terrific TAF bictegravir.

    伊恩,那我先回答關於愛滋病的問題。比克替拉韋的成功部分歸功於 Genvoya 的成功。已經接受治療的患者比例達到37%,這非常棒。這對TAF比克替拉韋來說是個非常好的預兆。我們喜歡這一點,因為我們正在再次為吉利德公司打造愛滋病毒產品線。所以,我們將擁有非常棒的 Genvoya 成分,我們也相信我們將擁有非常棒的 TAF bictegravir 成分。

  • So it's really, I think, operating on all fronts. As you've seen from the comments I made on Genvoya, we're getting about 10% of our Genvoya business from patients who are not currently on a Gilead regimen and we would hope to maintain that, perhaps even do better, once we have the additional arm of bictegravir F/TAF coming to join Genvoya. So we think about, if you like, both fronts. And Odefsey, Descovy also contributing to that but basically left hand/right hand Genvoya, and bic F/TAF. In terms of pricing -- competing on price.

    所以我覺得,它確實是在各方面都在運作。正如你從我對 Genvoya 的評論中看到的那樣,我們 Genvoya 業務的約 10% 來自目前未接受吉利德治療方案的患者,我們希望保持這一比例,甚至在比克替拉韋 F/TAF 加入 Genvoya 後做得更好。所以,我們可以同時考慮這兩個面向。Odefsey、Descovy 也對此有所貢獻,但基本上是左手/右手 Genvoya,以及 bic F/TAF。定價方面——價格競爭。

  • - President and CEO

    - President and CEO

  • Competing on price? Jim?

    價格競爭?吉姆?

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • I'm sorry. I didn't get the second part of the question. (multiple speakers)

    對不起。我沒看懂問題的第二部分。(多位發言者)

  • - President and CEO

    - President and CEO

  • So we don't compete on price but this category has been unique in this industry in that competition has lowered prices, so in fact, we have been competing on price for a few years now. So I don't see -- well, I don't understand the question because that's been the nature of how we've been competing in these markets, especially with regard to both the public and private markets.

    所以我們不打價格戰,但這個品類在業界很特殊,因為競爭降低了價格,所以實際上,我們已經打價格戰好幾年了。所以,我不明白——或者說,我不理解這個問題,因為這正是我們在這些市場中競爭的方式,尤其是在公共市場和私人市場中競爭的方式。

  • - Analyst

    - Analyst

  • I guess the question was more specific to AbbVie's new product offering and potential for pricing to go down further. Is there a willingness to sort of hold on here? Or are you willing to compete on price if the price is going down?

    我猜這個問題更具體地是關於艾伯維的新產品以及價格進一步下降的可能性。大家是否願意繼續堅持下去?或者,如果價格下降,你是否願意參與價格競爭?

  • - President and CEO

    - President and CEO

  • You know what? I'm not going to comment on that because I've been advised by Counsel that we can't comment on future product launches and how we would react to them. So I can't say anything.

    你知道嗎?我不會對此發表評論,因為我的法律顧問建議我們不能對未來的產品發布以及我們將如何應對發表評論。所以我什麼都不能說。

  • - Analyst

    - Analyst

  • Okay. Appreciate that, John. Thanks.

    好的。謝謝,約翰。謝謝。

  • Operator

    Operator

  • Katherine Breedis, Stifel.

    Katherine Breedis,Stifel。

  • - Analyst

    - Analyst

  • Great. Thanks very much for taking my question. With HCV, would it possible to perhaps provide a little more granularity around the patient volume by payer mix in the US? And along those lines, are we still tracking toward potentially reaching a point where the majority of VA patients with HCV will be treated by the third quarter of 2017? Thanks.

    偉大的。非常感謝您回答我的問題。對於 HCV,是否有可能提供美國按支付方構成劃分的患者數量更細緻一些的資訊?按照這個思路,我們是否仍有望在 2017 年第三季之前治療大部分患有丙型肝炎的退伍軍人事務部患者?謝謝。

  • - COO

    - COO

  • Great questions, Katherine, and I'll let Jim take the VA. Right now, in terms of payer mix, and it's been fairly steady for the last three quarters, about 45% of our HCV patients are coming from the public and about 55% from the commercial Medicare Part D. So that would be, I think, the rule of thumb. Obviously, that moves around depending on the very thing that you've raised, which is the VA. And I'll let Jim comment on the VA.

    凱瑟琳,你問的問題很好,我會讓吉姆去處理退伍軍人事務部的事。就支付方組成而言,過去三個季度以來相當穩定,大約 45% 的丙型肝炎患者來自公共醫療保險,約 55% 來自商業醫療保險 D 部分。我認為這就是大致的規律。顯然,這取決於你提出的問題,也就是退伍軍人事務部(VA)。至於退伍軍人事務部,就讓吉姆來評論吧。

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • Sure. I just would first say that no single entity has done a better job of identifying patients and getting them linked to care and treated than the VA and I think they're a model for the other sectors out there. They have treated a higher percentage of diagnosed patients than any other sector. So they're actually ahead of the non-VA population. And we're seeing similar dynamics within the VA as we are outside of the VA and we do expect a lower rate of treatment because of that in 2017.

    當然。首先我想說的是,在識別患者、幫助他們獲得護理和治療方面,沒有任何一個機構比退伍軍人事務部做得更好,我認為他們是其他行業的榜樣。與其他任何行業相比,他們收治的確診患者比例更高。所以他們的實際水準比非退伍軍人事務部人口高。我們看到退伍軍人事務部內部和外部的動態類似,因此我們預期 2017 年的治療率會因此而降低。

  • And because the VA is actually ahead of the non-VA population, we would expect that VA patient starts would represent a decreasing percentage of Gilead HCV patient starts in 2017 compared to what they've represented over the last several years. So again, the vast majority of diagnosed veterans are going to get treated. I can't tag an exact date on that, but they're doing a great job and funding has not been an issue.

    由於退伍軍人事務部 (VA) 的患者數量實際上領先於非 VA 患者,我們預計 2017 年 VA 患者的治療起始數量佔吉利德丙型肝炎治療起始數量的比例將比過去幾年有所下降。所以,絕大多數確診的退伍軍人都會得到治療。我無法給出確切的日期,但他們做得很好,資金也一直不是問題。

  • - Analyst

    - Analyst

  • And maybe if I could ask a follow up. Is it tracking faster than we have seen? I mean, is it possible that, that patient population will be treated earlier than the third quarter of 2017? Just to get a sense of the gating of the tails. That would be great. Thank you. Thank you.

    或許我可以問一個後續問題。它的追蹤速度比我們之前看到的要快嗎?我的意思是,這部分患者是否有可能在 2017 年第三季之前接受治療?只是為了感受一下尾巴的擺動狀況。那太好了。謝謝。謝謝。

  • - COO

    - COO

  • Katherine, if I could just jump in there. We have no real hard data from the VA. Our type of feel for the VA is through conversations. As Jim said, it's been very, very impressive. And you've got to give the VA credit. So again, the slope, the times are very, very difficult for us to get specific on.

    凱瑟琳,如果我能插手就好了。我們沒有來自退伍軍人事務部的確切數據。我們對退伍軍人事務部的了解是透過對話實現的。正如吉姆所說,這非常、非常令人印象深刻。你必須承認退伍軍人事務部的貢獻。所以,再次強調,坡度、時間對我們來說非常非常難以給出具體數據。

  • - President and CEO

    - President and CEO

  • Let's go to the next question.

    我們來看下一個問題。

  • Operator

    Operator

  • Brian Skorney, Robert Baird.

    布萊恩·斯科尼,羅伯特·貝爾德。

  • - Analyst

    - Analyst

  • Good afternoon, guys. Thanks for taking the question. I guess when I look at slide 22, and we're talking about a non-HCV net product sales guidance, I'm just wondering, it looks like where you have bracketed off the ex-US tenofovir patent expiration. It seems like that assumes the entire loss of ex-US Viread sales to make that number despite it not expiring until July.

    下午好,各位。感謝您回答這個問題。我想,當我看到第 22 張幻燈片,並且我們正在討論非 HCV 淨產品銷售指導時,我只是想知道,看起來你們把美國以外的替諾福韋專利到期日排除在外了。看起來,這似乎假設美國以外 Viread 銷售額的全部損失才能達到這個數字,儘管該條款要到 7 月才到期。

  • So I'm just wondering, is there anything more we should be expecting in terms of the tenofovir patent expiration impacting other products that you're taking into account there? And where in this slide are you taking into account any ex-US HIV growth? Because it seems like there's only US HIV there. Thanks,

    所以我想知道,關於替諾福韋專利到期對其他產品的影響,我們是否還有其他需要注意的地方?這張投影片中哪裡考慮了美國以外地區的愛滋病毒感染人數成長?因為那裡似乎只有美國的愛滋病毒感染者。謝謝,

  • - COO

    - COO

  • Hey, Brian. There is some very nice growth. Again, I direct you back to the slide on Genvoya, Descovy, Odefsey in Germany, which is -- those lines are I'm absolutely delighted with. And again, I repeat that our teams, whether it be here in the US or around the globe, are really executing at a high level. I would simply say that the block that you're looking at on slide 22 does include a mix of our TDF products.

    嘿,布萊恩。成長勢頭非常好。再次提醒大家,請看關於德國 Genvoya、Descovy、Odefsey 的那張幻燈片,我對那些線條非常滿意。我再次重申,我們的團隊,無論是在美國還是在全球各地,都展現出了高水準的執行力。我只想說,您在第 22 頁投影片上看到的板塊確實包含了我們 TDF 產品的組合。

  • So it's Viread and it is also Truvada, because I think as you might know, the FTC patent predates the TDF patents in Europe. So there is the potential for effect not only on pure Viread, but on Truvada.

    所以它既是 Viread,也是 Truvada,因為我想您可能知道,FTC 的專利早於歐洲的 TDF 專利。因此,它不僅可能對純 Viread 產生影響,而且可能對 Truvada 產生影響。

  • - EVP, Worldwide Commercial Operations

    - EVP, Worldwide Commercial Operations

  • Recall as well, it's a year in which we're going to have launches throughout the year of the TAF portfolio. So this is the combined picture of both growth and generic impact for 2017. Moving forward, as we said, with the launch of the full TAF portfolio, including bic/TAF, we expect this to be a growth driver globally for us.

    此外,請記住,今年我們將全年推出 TAF 產品組合中的多款產品。所以,這是 2017 年成長和整體影響的綜合情況。展望未來,正如我們所說,隨著包括 bic/TAF 在內的全系列 TAF 產品組合的推出,我們預計這將成為我們在全球範圍內的成長動力。

  • - Analyst

    - Analyst

  • Okay, I guess what I'm really unclear on is where the ex-US --?

    好吧,我真正不清楚的是,前美國——?

  • - President and CEO

    - President and CEO

  • We can follow up with you.

    我們可以與您聯絡。

  • - Analyst

    - Analyst

  • Okay, that would be great. Thanks.

    好的,那太好了。謝謝。

  • Operator

    Operator

  • Thank you and we have time for one last question. Jim Birchenough, Wells Fargo.

    謝謝,我們還有時間回答最後一個問題。吉姆·伯奇諾,富國銀行。

  • - Analyst

    - Analyst

  • Hi, guys. Thanks for fitting me in. I guess you're describing two very different businesses with the non-HCV sales growth and the declining HCV portfolio without a clear sense of where the bottom is there. So the question is, is there any thought to splitting those businesses? It's a question I've got. I've thought about it. I'm wondering what the logical considerations would be against doing that?

    嗨,大家好。謝謝你安排我過來。我想你是在描述兩個截然不同的業務:非丙型肝炎業務的銷售成長和丙型肝炎業務組合的下滑,而且你也沒有清楚地知道丙型肝炎業務的底部在哪裡。所以問題是,有沒有考慮過要拆分這些企業?這是我的一個疑問。我考慮過了。我想知道反對這樣做的邏輯理由是什麼?

  • And then the second part would be assuming the business remains melded together, what commitment can you make to growing the overall business beyond 2017? I understand taking it a year at a time from a projections perspective. But I think investors would like some commitment to growth and to understand the initiatives you're going to take to do that?

    其次,假設企業維持合併狀態,您能做出哪些承諾來推動企業在 2017 年以後的整體發展?我理解從預測的角度來看,應該一年一年來考慮。但我認為投資人希望看到公司對成長做出承諾,並了解公司將採取哪些措施來成長?

  • - President and CEO

    - President and CEO

  • Jim, the answer is no. We're not considering splitting up the Company. And while it looks good in the world of Wall Street from a multiples perspective, I think it's an economically and financially a bad idea for the Company. So we are committed to growing the Company. We're committed to our field of NASH. We're committed to growing that HIV field. And we are going to continue to accelerate our pipeline through acquisitions and whatnot over the course of the year.

    吉姆,答案是否定的。我們不考慮拆分公司。雖然從華爾街的估值倍數來看,這看起來不錯,但我認為這對公司而言,無論從經濟角度還是財務角度來看,都是一個糟糕的想法。因此,我們致力於公司的發展。我們致力於 NASH 領域的研究。我們致力於發展愛滋病領域。今年我們將持續透過收購等方式加速產品線開發。

  • This is a challenging situation. I understand it. We understand it. And we're here somewhat reporting the news to you of what the world of HCV looks like as it's declining faster this year than we would have predicted last year. And we're dealing with it through our strength of the balance sheet, through the cash flow we'll have at HCV, so that we can get the Company back to growth. But at this point, I'm not going to give you a point in time when that's going to happen.

    這是一個棘手的局面。我明白了。我們明白。我們在此向大家通報C型肝炎的最新情況,今年C型肝炎的發生率下降速度比我們去年預測的還要快。我們正在利用我們強大的資產負債表和HCV的現金流來應對這個問題,以便我們能夠使公司恢復成長。但目前,我無法告訴你這件事會在何時發生。

  • - Analyst

    - Analyst

  • Great. Thanks for take the questions

    偉大的。謝謝你回答這些問題

  • Operator

    Operator

  • Thank you and this concludes today's question-and-answer session. I would now like to turn the call back to Sung Lee for closing remarks.

    謝謝大家,今天的問答環節到此結束。現在我把電話轉回給李成,請他作總結發言。

  • - VP of IR

    - VP of IR

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

  • Operator

    Operator

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

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