吉利德科學 (GILD) 2016 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Gilead Sciences second-quarter 2016 earnings conference call. My name is Candace, and I will be your conference operator today.

女士們、先生們，感謝你們的耐心等待。歡迎參加吉利德科學公司2016年第二季財報電話會議。我叫坎迪斯，今天我將擔任你們的會議接線生。

(Operator Instructions)

（操作說明）

As a reminder, this conference call is being recorded. I'd like to turn the call over to Sung Lee, Vice President of Investor Relations. Please go ahead.

再次提醒，本次電話會議正在錄音。我謹將電話轉交給投資人關係副總裁李成先生。請繼續。

Great. Thank you, Candace, and good afternoon, everyone.

偉大的。謝謝你，坎迪斯，大家下午好。

Just after market closed today a press release was issued with earnings results for the second quarter of 2016. The press release and detailed slides are available on the Investor Relations section of the Gilead website. Joining today's call will be John Milligan, President and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; Kevin Young, Chief Operating Officer; and Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer.

今天股市收盤後不久，該公司發布了一份新聞稿，公佈了2016年第二季的獲利結果。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。今天參加電話會議的有：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；營運長凱文·楊；以及研發執行副總裁兼首席科學官諾伯特·比肖夫伯格。

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. A description of these risks can be found in the latest SEC disclosures documents and recent press releases.

在我們正式發言之前，請允許我提醒各位，我們將發表一些前瞻性聲明，包括有關產品、候選產品、財務預測和資本使用的計劃和預期，所有這些都涉及某些我們無法控制的假設、風險和不確定性，這些因素可能導致實際結果與這些聲明存在重大差異。有關這些風險的描述可以在最新的美國證券交易委員會披露文件和最近的新聞稿中找到。

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

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

I will now turn the call over to Robin.

現在我會把通話轉給羅賓。

Thanks, Sung, and good afternoon, everyone.

謝謝宋，大家午安。

We are pleased to share results for the second quarter of 2016. I'll first review our financials and Kevin and John will then make a few comments.

我們很高興與大家分享2016年第二季的業績。我先來看看我們的財務狀況，然後凱文和約翰會提出一些意見。

Total revenues for the second quarter were $7.8 billion, with non-GAAP diluted earnings per share of $3.08. This compares to revenues of $8.2 billion and non-GAAP earnings per share of $3.15 for the same period last year. Product sales for the second quarter were $7.7, billion down 6% year over year and flat sequentially. The year-over-year decline was driven by lower HCV sales, partially offset by increased sales in HIV and other therapeutic areas. Sequentially, we saw an increase in HIV, US HPV, and other product sales that were offset by a decline in HCV sales in Japan and Europe.

第二季總營收為 78 億美元，非 GAAP 稀釋後每股收益為 3.08 美元。相比之下，去年同期營收為 82 億美元，非 GAAP 每股收益為 3.15 美元。第二季產品銷售額為77億美元，較去年同期下降6%，季減。年比下降的原因是丙型肝炎病毒 (HCV) 病毒的銷量下降，但愛滋病毒 (HIV) 病毒和其他治療領域的銷售成長部分抵消了這一影響。從順序上看，HIV、美國 HPV 和其他產品的銷售額有所增長，但日本和歐洲 HCV 銷售額的下降抵消了這一增長。

Turning to the US, product sales for the second quarter were $4.9 billion, down 12% year over year. HCV product sales were $2.3 billion, down 33% year over year, driven by lower revenues per patient as a result of increased rebates and discounts due primarily to payer mix and lower patient starts for Harvoni as the initial group of warehouse patients was treated in 2015. Sequentially, our HCV product sales were up 13%, driven by a $270 million adjustment to our HCV sales returns reserves rate and the initial inventory build for Epclusa. Strong uptake of our TAF-based regimens drove 23% year-over-year and 11% sequential growth of our HIV product sales. The quarterly revenues of $2.2 billion were also positively impacted by the upward trajectory of Trevata use for PrEP.

再來看美國市場，第二季產品銷售額為 49 億美元，較去年同期下降 12%。HCV 產品銷售額為 23 億美元，年減 33%，主要原因是由於支付方組合變化導致回扣和折扣增加，以及 Harvoni 患者數量減少（因為第一批倉庫患者在 2015 年接受了治療），導致每位患者的收入下降。與上一季相比，我們的HCV產品銷售額成長了13%，這主要得益於我們對HCV銷售退貨準備率進行了2.7億美元的調整，以及Epclusa的初始庫存建設。我們基於 TAF 的治療方案的強勁市場接受度推動了 HIV 產品銷售額同比增長 23%，環比增長 11%。PrEP 藥物 Trevata 使用量的上升趨勢也對季度收入 22 億美元產生了正面影響。

Turning to Europe, product sales for the second quarter were $1.6 billion, down 18% year over year, primarily driven by lower HCV patient starts and a higher proportion of patient starts from countries that have a lower net average price. Sequentially, sales in Europe were flat excluding the impact of currency movements with HIV sales growth offset by lower HCV sales. In Japan, product sales for the second quarter were $619 million, down 43% sequentially as a result of lower patient starts on Harvoni and the full-quarter effect of the mandatory price reductions for both Sovaldi and Harvoni, which were discussed during our last call.

再來看歐洲，第二季產品銷售額為 16 億美元，較去年同期下降 18%，主要原因是 HCV 患者起始治療人數減少，以及來自淨平均價格較低國家的患者起始治療人數比例較高。從環比來看，剔除匯率波動的影響，歐洲的銷售額持平，HIV 銷售額的成長被 HCV 銷售額的下降所抵消。在日本，第二季度產品銷售額為 6.19 億美元，環比下降 43%，原因是 Harvoni 的患者數量減少，以及 Sovaldi 和 Harvoni 強制降價對整個季度的影響，我們在上次電話會議中討論過這些問題。

Moving to gross margins, our non-GAAP product gross margin for the second quarter of 2016 was 92% and benefited from the reversal of a $200 million litigation charge recorded in the first quarter of 2016 following the favorable decision in the Merck case.

再來看毛利率，我們 2016 年第二季的非 GAAP 產品毛利率為 92%，這得益於 2016 年第一季因默克案勝訴而提列的 2 億美元訴訟費用的衝回。

Now turning to expenses, non-GAAP R&D expenses were $1 billion for the second quarter, up 48% compared to the same period last year, primarily due to the purchase of a US Food and Drug Administration priority review voucher and the progression of clinical studies. Non-GAAP SG&A expenses for the second quarter were up 10% compared to the same period last year, primarily due to higher cost to support new product launches and our geographic expansion.

現在來看費用，第二季非GAAP研發費用為10億美元，比去年同期成長48%，主要原因是購買了美國食品藥物管理局的優先審查券以及臨床研究的進展。第二季非GAAP SG&A費用較去年同期成長10%，主要原因是支持新產品上市和地理擴張的成本增加。

From a balance sheet perspective, during the second quarter we generated cash flow from operations of $4.9 billion and ended the quarter with $24.6 billion in cash and investments. While our cash flows will remain in the second half of the year, we anticipate a sequential decrease in Q3 2016 and to require cash payments related to accrued government rebate in the US and abroad, as well as milestone payments associated with our R&D pipeline progression.

從資產負債表的角度來看，第二季我們透過經營活動產生了 49 億美元的現金流，季末我們擁有 246 億美元的現金和投資。雖然我們的現金流在今年下半年將保持不變，但我們預計 2016 年第三季將環比下降，並且需要支付與美國和海外應計政府退稅相關的現金，以及與我們的研發管線進展相關的里程碑付款。

We continue to return capital to our shareholders through the dividends and share repurchases. During the second quarter, we repurchased 10.5 million shares for $1 billion under the $12 billion 2016 share repurchase program. We received an additional 8.1 million shares in April 2016 from the final settlement of a accelerated share repurchase program announced in February 2016. The total share repurchases in the first half of the year were 98.2 million at a cost of $9 billion. As previously communicated, we anticipate share repurchases in the second half of 2016 to be lower than the first half of 2016 as we focus our capital allocations on advancing our R&D opportunities.

我們將繼續透過分紅和股票回購向股東返還資本。第二季度，我們根據 2016 年 120 億美元的股票回購計劃，以 10 億美元的價格回購了 1,050 萬股股票。2016 年 4 月，我們透過 2016 年 2 月宣布的加速股票回購計畫的最終結算，獲得了額外的 810 萬股股票。今年上半年股票回購總額為 9,820 萬股，耗資 90 億美元。如同先前所溝通的，我們預計 2016 年下半年的股票回購規模將低於 2016 年上半年，因為我們將把資本配置重點放在推進研發機會上。

Finally, we are updating full-year 2016 guidance, which is outlined on slide 21. The changes are as follows. We are lowering net product sales guidance to a range of $29.5 billion to $30.5 billion. While we are seeing continued strength in non-HCV product sales, given the current trends in payer and patient flow dynamics for HCV, our updated models suggest net product sales will range from being slightly above to slightly below $30 billion for the year. As such, we believe it is prudent to update our full-year 2016 guidance.

最後，我們將更新 2016 年全年業績指引，詳情請見第 21 頁投影片。具體變更如下。我們將淨產品銷售額預期下調至 295 億美元至 305 億美元之間。儘管我們看到非 HCV 產品銷售持續強勁，但鑑於目前 HCV 支付方和患者流動動態的趨勢，我們更新後的模型表明，今年的淨產品銷售額將在略高於 300 億美元到略低於 300 億美元之間。因此，我們認為有必要更新我們 2016 年全年業績指引。

The factors contributing to this conclusion include lower HCV revenue per patient as a result of a mix shift towards more heavily discounted payer segments in the US and countries with a lower net average price in Europe, a trend toward slowing patient starts in the US commercial segment and some earlier launch markets of Europe, the continued gradual trends towards shorter duration and loss of some market share to competition. This guidance is subject to a number of uncertainties, including potential changes in the global macroeconomic environment, adoption of additional pricing measures to reduce HCV spending, volatility in foreign currency exchange rates, inaccuracy in our HCV patient start estimates, additional competitive launches in HCV, and increase in discounts, chargebacks and rebates due to ongoing commercial payer contract negotiations and a larger-than-anticipated shift in payer mix to more highly discounted payer segments such as PHS, FSF, Medicaid, and the VA.

導致這一結論的因素包括：由於美國和歐洲國家支付方折扣力度加大，導致每位 HCV 患者的收入下降；美國商業市場和歐洲一些較早上市市場的患者啟動速度放緩；治療持續時間持續縮短；以及市場份額因競爭而減少。該指導意見受多種不確定因素的影響，包括全球宏觀經濟環境的潛在變化、為減少 HCV 支出而採取的額外定價措施、外匯匯率的波動、我們對 HCV 患者起始數量的估計不准確、HCV 領域其他競爭產品的推出，以及由於正在進行的商業支付方合約談判和支付方組合向折扣轉變更高的支付方（如 PHS、FSF、

We are increasing our R&D expense guidance to a range of $3.6 billion to $3.8 billion, driven by acquisition-related expenses for Nimbus Apollo, Inc. and the purchase of a US Food and Drug Administration priority review voucher, slightly offset by lower-than-anticipated clinical trial expenses. We are lowering SG&A expense guidance to a range of $3.1 billion to $3.3 billion, primarily driven by the favorable one-time adjustment to the expected invoice from the IRS for the Branded Prescription Drug fee, which lowered Q1 2016 SG&A expense.

由於收購 Nimbus Apollo, Inc. 的相關費用，我們將研發支出預期提高至 36 億美元至 38 億美元。此外，還購買了美國食品藥物管理局的優先審評券，但臨床試驗費用低於預期，略微抵銷了這筆支出。我們將銷售、一般及行政費用預期下調至 31 億美元至 33 億美元，主要原因是美國國稅局對品牌處方藥費用的預期發票進行了有利的一次性調整，從而降低了 2016 年第一季的銷售、一般及行政費用。

Diluted EPS impact of acquisition-related up-front collaboration, stock-based compensation and other expenses increases to a new range of $1.47 to $1.53 as a result of our recent M&A activity. All other components of our 2016 guidance remained unchanged.

由於我們最近的併購活動，與收購相關的預付合作、股票選擇權費用和其他費用對稀釋後每股盈餘的影響增加到 1.47 美元至 1.53 美元的新區間。2016 年業績指引的其他所有組成部分均保持不變。

I would like to now turn the call over to Kevin.

現在我想把電話交給凱文。

Thank you, Robin, and good afternoon, everyone.

謝謝你，羅賓，大家下午好。

Let me say immediately how terrific it is to be back at Gilead in a full-time capacity. Working with exceptional executive colleagues around the table here in Foster City, interacting with my senior operating management team, and seeing the dedication of thousands of Gilead employees around the world, leaves me in no doubt as to the long-term prospects for this outstanding Company.

讓我立刻表達一下能夠以全職員工的身份回到吉利德公司是多麼棒的一件事。在福斯特城與傑出的管理同事們圍坐一桌，與我的高級營運管理團隊互動，並親眼目睹吉利德全球數千名員工的奉獻精神，讓我對這家傑出公司的長期前景充滿信心。

While it's early days, over the last two months in my new role I've had the opportunity to reflect on Gilead's recent product introductions, the evolving healthcare landscape, and the operating challenges on our near-term horizon. I'd like to share three general observations with you today.

雖然現在還處於初期階段，但在我擔任新職務的過去兩個月裡，我有機會反思吉利德最近推出的產品、不斷變化的醫療保健格局以及我們近期面臨的營運挑戰。今天想和大家分享三點整體看法。

First, I am struck by the commitment that is shared by physicians, payers and governments around the world to reduce the prevalence of hepatitis C. Even countries with challenging economic circumstances are finding ways to prioritize the treatment of HCV patients. In the 2.5 years since the launch of Sovaldi, more than 1 million patients have been treated on a sofosbuvir-based regimen.

首先，令我印象深刻的是，世界各地的醫生、支付方和政府都致力於降低C型肝炎的盛行率。即使是經濟情勢嚴峻的國家，也在想辦法優先治療C型肝炎患者。自 Sovaldi 上市以來的 2.5 年裡，已有超過 100 萬名患者接受了基於索非布韋的治療方案。

Beneath this aggregated number are several landmark statistics. The United States has already treated nearly 0.5 million patients to date with Sovaldi and Harvoni. Equally, over 200,000 patients in Europe have been treated with Gilead regimens. Japan has treated approximately 100,000 patients in a little over a year, and just this year Australia has treated an estimated 17,000 patients in a matter of months.

在這個總結數字下方，還有幾項具有里程碑意義的統計數據。迄今為止，美國已使用 Sovaldi 和 Harvoni 治療了近 50 萬名患者。同樣，歐洲已有超過 20 萬名患者接受了吉利德公司的治療方案。日本在一年多一點的時間裡治療了大約 10 萬名患者，而光是今年，澳洲就在短短幾個月內就治療了約 1.7 萬名患者。

Health care systems have demonstrably mobilized to reach those patients most in need. These are remarkable facts that clearly underscore the profile of the products we have introduced. Equally, they have implications to longer term treatment dynamics and portfolio life cycles.

醫療衛生系統已明顯調動資源，為最需要的患者提供協助。這些顯著的事實清楚地突顯了我們所推出產品的特性。同樣，它們對長期治療動態和投資組合生命週期也有影響。

Secondly, in the area of HIV, I'm impressed by how the clinical data of TAF-based regimens are resonating with the many constituents who tirelessly drive for better patient care. The understanding that these regimens can help address a growing need for highly effective and safer treatment options for life-long HIV therapy is evidenced by the early success of Genvoya. I will highlight some impressive data points later.

其次，在 HIV 領域，我印象深刻的是，基於 TAF 的治療方案的臨床數據引起了許多為改善患者護理而不懈努力的人士的共鳴。Genvoya 的早期成功證明了這些治療方案有助於滿足人們對高效、安全的終身 HIV 治療方案日益增長的需求。稍後我會重點介紹一些令人印象深刻的數據點。

Thirdly, I'm reminded just how complex the delivery of health care continues to be. Gilead's focus on flawless execution, on controlling the variables that we can control with the highest levels of conduct and compliance is critical and it is my top priority.

第三，這讓我意識到醫療保健服務的提供仍然有多複雜。吉利德注重完美執行，注重以最高標準的行為和合規性控制我們能夠控制的變量，這一點至關重要，也是我的首要任務。

Now I will look into the details of the commercial performance for the second quarter, starting with HCV. In the US, total HCV revenue is $2.3 billion, up 13% sequentially and down 33% year over year. Since the beginning of the year, access has improved and almost all major commercial payers have been moved by fibrosis score criteria, joining Medicare and the VA in this regard. Medicaid remains the only payer segment where use is still generally restricted to the sicker patients. There are other significant barriers to access, but we are encouraged that some states have recently moved away from fibrosis restrictions towards more open access.

現在我將詳細了解第二季的商業業績，首先從HCV開始。在美國，HCV 總營收為 23 億美元，季增 13%，年減 33%。自年初以來，醫療服務取得情況有所改善，幾乎所有主要商業保險公司都已按照纖維化評分標準進行調整，與聯邦醫療保險和退伍軍人事務部一樣，採取了這種做法。醫療補助計劃仍然是唯一使用醫療補助的支付方，其服務對象通常仍僅限於病情較重的患者。雖然還有其他一些重大障礙，但我們感到欣慰的是，一些州最近不再限制纖維化，而是轉向更開放的准入方式。

In terms of patient starts, approximately 59,000 people began HCV therapy in the second quarter and an estimated 90% of these patients started on a sofosbuvir-based regimen. Importantly, third-party databases suggest that new patients are being identified through increased screening efforts. As evidence, approximately 14 million people were screened for HCV for the period of 2014 through 2015 and approximately 280,000 were confirmed RNA positive in that two-year period. These figures represent a significant increase from the years prior to the launch of Sovaldi. We estimate 3 million individuals remain infected with HCV in the US, approximately half of whom are diagnosed.

就患者數量而言，第二季度約有 59,000 人開始接受 HCV 治療，據估計，其中 90% 的患者開始接受以索非布韋為基礎的治療方案。重要的是，第三方資料庫顯示，透過加強篩檢工作，正在發現新的患者。作為證據，在 2014 年至 2015 年期間，約有 1,400 萬人接受了 HCV 篩檢，並在兩年內確認約有 28 萬人 RNA 呈陽性。這些數據表明，與 Sovaldi 上市之前的幾年相比，出現了顯著增長。據估計，美國仍有 300 萬人感染C型肝炎病毒，其中約一半已確診。

Although patient starts increased for the second consecutive quarter, and patient inflows into care remained reasonably steady at around 30,000 patients a month, the dynamics vary by patient segment. Within the commercial and Medicare segments, some larger payers have recently opened up access. We now estimate that up to 90% of all commercial covered lives have access without regard to fibrosis score. While the payers that recently opened up access are bringing in more patients, we are seeing a modest downward trend in patient starts among payers that have had full access in place for longer periods of time. The sickest patients have largely been treated and the movement we are seeing is towards treating genotype 1 patients with lower fibrosis score and thus greater use of the eight-week treatment regimen for Harvoni.

儘管患者新發病例連續第二個季度增加，且每月接受治療的患者人數保持相對穩定，約 30,000 人，但不同患者群體的情況有所不同。在商業保險和聯邦醫療保險領域，一些較大的支付方最近開放了准入管道。我們現在估計，高達 90% 的商業保險參保人員無需考慮纖維化評分即可獲得保險。雖然最近開放准入的支付方吸引了更多患者，但我們看到，對於那些已經全面開放准入較長時間的支付方而言，患者數量出現了輕微的下降趨勢。病情最嚴重的患者大多已經接受治療，我們看到的趨勢是治療基因型 1 患者，這些患者的纖維化評分較低，因此更多地使用 Harvoni 的八週治療方案。

In terms of all new HCV treatment starts in the second quarter, approximately 45% came from within the public payer systems. We anticipate this percentage will remain largely the same through the remainder of the year. The VA is one example of a payer within this segment and their commitment to treating and curing veterans who have HCV, using budget allocated by Congress to do so, is truly groundbreaking.

在第二季所有新增的C型肝炎治療病例中，約有 45% 來自公共支付系統。我們預計這一比例在今年剩餘時間內將基本保持不變。退伍軍人事務部是這一領域的支付方之一，他們致力於使用國會撥款的預算來治療和治癒患有丙型肝炎的退伍軍人，這確實具有開創性意義。

We are aware that in some cities, extra clinics have been scheduled to help shoulder the workload. However, we also expect that in the longer term, socially disadvantaged patients within the VA system will be harder to reach and bring to care and that the rate of treatment will decline.

我們了解到，在某些城市，已經安排了額外的診所來幫助分擔工作量。然而，我們也預計，從長遠來看，退伍軍人事務部系統中社會弱勢患者將更難獲得治療，治療率也會下降。

Turning to Europe, total HCV revenue in second quarter was $775 million, down 32% year over year and down 7% sequentially. Overall, Gilead patient starts decreased to around 28,000 for the quarter. We observed steady treatment rates in Italy and Spain, but lower numbers in early launch markets like Germany and France. Patient starts in the UK continue to be limited by NHS England budget restrictions. Additionally, we saw a slight decline in average treatment duration, as countries like Germany are treating more patients with low fibrosis scores who qualify for an eight-week treatment duration.

再來看歐洲市場，第二季HCV總營收為7.75億美元，年減32%，季減7%。本季吉利德的患者起始數量整體下降至約 28,000 例。我們觀察到義大利和西班牙的治療率保持穩定，但在德國和法國等早期上市市場，治療率較低。英國的患者開診數量仍受到英格蘭國民醫療服務體系（NHS England）預算限制的影響。此外，我們看到平均治療持續時間略有下降，因為像德國這樣的國家正在治療更多纖維化評分較低、符合八週治療條件的患者。

In several European markets, locally documented cure rates are equal to, if not better than, what was demonstrated in Sovaldi and Harvoni clinical studies. This has resonated with governments and payer bodies and some countries, such as France are considering removing all fibrosis score criteria. We will watch this picture closely and share evolving news with you in the future.

在一些歐洲市場，當地記錄的治癒率與 Sovaldi 和 Harvoni 臨床研究中證明的治癒率相當，甚至更高。這引起了各國政府和支付機構的共鳴，一些國家，如法國，正在考慮取消所有纖維化評分標準。我們會密切關注事態發展，並在未來與您分享最新進展。

Moving to Japan, as Robin mentioned, revenue was $619 million, down 43% sequentially. We believe this was related to two factors. First, the decline in genotype 1 new patient starts following the Q1 2016 peak, when a very large number of individuals with advanced disease initiated therapy. Second, the full three-month effect of a mandatory price reduction previously described on last quarter's call.

正如 Robin 所提到的，日本市場的收入為 6.19 億美元，環比下降 43%。我們認為這與兩個因素有關。首先，基因型 1 新患者數量的下降始於 2016 年第一季的高峰之後，當時大量晚期患者開始接受治療。其次，上個季度電話會議上描述的強制性降價措施將持續三個月，並產生全面影響。

Finally for HCV, Epclusa was recently approved in the US, the EU, and Canada. These approvals are true milestones in patient care since Epclusa is the first pan-genotypic once-daily single-tablet option. Epclusa will be an important treatment option in the US as an estimated 20% to 25% of HCV patients have genotypes 2 and 3 and equally across Europe, there are some countries that have up to 30% of patients with genotype 3 alone.

最後，針對丙型肝炎病毒，Epclusa 最近已在美國、歐盟和加拿大獲得批准。這些批准是患者護理的真正里程碑，因為 Epclusa 是第一個泛基因型每日一次的單片治療方案。Epclusa 將成為美國的重要治療選擇，因為據估計，20% 至 25% 的 HCV 患者患有 2 型和 3 型基因型；同樣，在歐洲，一些國家高達 30% 的患者僅患有 3 型基因型。

In concluding my remarks on hepatitis C, I will return to my earlier comments. Gilead is proud to part of a fundamental disease paradigm shift, delivering disease cures to virtually all patients treated. That's why we developed Sovaldi, Harvoni and Epclusa and have a third single-tablet regimen in clinical testing. Whilst the pace of new patient treatment may slow in coming years and quantifying that pace is incredibly hard, there is still an opportunity to identify and cure many HCV-infected people around the globe.

在結束關於丙型肝炎的發言時，我將回到我之前的評論。吉利德很自豪能夠參與這場根本性的疾病範式轉變中，為幾乎所有接受治療的患者帶來疾病治癒。這就是為什麼我們開發了 Sovaldi、Harvoni 和 Epclusa，目前還有第三種單片療法正在進行臨床試驗。雖然未來幾年新患者治療的速度可能會放緩，而且量化這一速度極其困難，但我們仍然有機會在全球範圍內發現並治愈許多丙型肝炎病毒感染者。

Moving to HIV, we are pleased with the launch of our TAF-based products in the US and in the European markets while we have already achieved reimbursement. In the US, total HIV and other antiviral revenue was $2.2 billion, up 11% sequentially and Genvoya revenue nearly doubled in Q2 versus Q1. The (inaudible) represents the most successful HIV launch since the introduction of Atripla, the first single-tablet regimen, a decade ago. After its first six months of availability, Genvoya is already the most prescribed regimen for both treatment naive and switch patients.

轉向 HIV 領域，我們很高興看到我們基於 TAF 的產品在美國和歐洲市場推出，並且我們已經獲得了報銷。在美國，HIV 和其他抗病毒藥物的總收入為 22 億美元，較上季成長 11%，Genvoya 的營收在第二季比第一季幾乎翻了一番。（聽不清楚）代表了自十年前推出首個單片療法 Atripla 以來最成功的 HIV 藥物上市。Genvoya上市僅六個月，就已成為初治患者和轉診患者處方量最高的治療方案。

78% of all Genvoya prescriptions have come from switches. Half of the switches have come from Stribild and importantly, 10% of switches have come from non-Gilead therapies. Among all patients who switch, we have seen an increase our inability to retain patients on a Gilead product. While still in the early stages of the Odefsey and Descovy launch, we are seeing similar patient dynamics to Genvoya. Over 90% of all Odefsey and Descovy prescriptions have come from switches, and 6% and 11% of switches respectively have come from non-Gilead therapies.

Genvoya 所有處方中有 78% 來自轉換用戶。其中一半的轉換來自 Stribild，更重要的是，10% 的轉換來自非吉利德療法。在所有轉用吉利德產品的患者中，我們發現患者持續使用吉利德產品的能力下降。雖然 Odefsey 和 Descovy 的上市仍處於早期階段，但我們看到它們的患者動態與 Genvoya 類似。超過 90% 的 Odefsey 和 Descovy 處方來自轉換治療，其中分別有 6% 和 11% 的轉換治療來自非吉利德療法。

Finally in the US, I would like to highlight the growing use of Truvada for PrEP. We estimate somewhere in the order of 60,000 to 70,000 patients were using Truvada for PrEP in the second quarter. This number accounts for approximately one-third of Truvada demand. This is encouraging as we know Truvada has been important role to play as part of comprehensive HIV prevention for many at-risk individuals.

最後，我想重點介紹美國 Truvada 在 PrEP 中的日益普及。我們估計，第二季約有 6 萬至 7 萬名患者使用 Truvada 進行 PrEP。這個數字約佔 Truvada 需求的三分之一。令人鼓舞的是，我們知道 Truvada 在為許多高風險族群提供全面的 HIV 預防方面發揮了重要作用。

Turning to Europe, total HIV and other antiviral revenue was $755 million, up 5% sequentially, driven by the launches of Genvoya and Descovy. Genvoya has gained pricing approval in 11 countries, and is now the market leader in Germany for both treatment naive and switch patients after only six months of availability. We anticipate additional launches in France, Italy and the UK in the second half of the year.

再來看歐洲市場，HIV 和其他抗病毒藥物的總收入為 7.55 億美元，環比成長 5%，這主要得益於 Genvoya 和 Descovy 的上市。Genvoya 已在 11 個國家獲得定價批准，上市僅 6 個月後，就已成為德國市場領先的藥物，適用於初治患者和轉換治療患者。我們預計今年下半年將在法國、義大利和英國推出更多產品。

Genvoya is a preferred regimen in several HIV treatment guidelines, including Italy where it was added before pricing and reimbursement. Preferred listings are anticipated in other EU guidelines later this year and into 2017. EACS guidelines are expected to be updated following the HIV Glasgow 2016 conference in October.

Genvoya 是多項 HIV 治療指南中的首選方案，包括義大利（在定價和報銷之前就已將其納入指南）。預計歐盟其他指導方針將於今年稍後和 2017 年出台優先清單。EACS 指南預計將在 2016 年 10 月的格拉斯哥 HIV 大會之後進行更新。

Finally, I would like to briefly update you on the outstanding performance of the Gilead US cardiovascular team. Letairis and Ranexa together generated $356 million in revenue during the quarter, representing a 12% year-over-year increase. Today, over 0.25 million people in the United States regularly receive Ranexa and Letairis remains the overall ERA market leader in PAH. In closing, Gilead achieved a great deal across our operations during the quarter and I am confident that we will continue to make significant progress in the second half of 2016.

最後，我想簡單地向大家報告吉利德美國心血管團隊的優異表現。Letairis 和 Ranexa 本季共創造了 3.56 億美元的收入，年增 12%。如今，美國有超過 25 萬人定期接受 Ranexa 治療，而 Letairis 仍然是 PAH 領域 ERA 市場的領導者。綜上所述，吉利德在本季度各項業務中取得了巨大成就，我相信我們將在 2016 年下半年繼續取得重大進展。

I would now like to turn the call over to John.

現在我想把電話交給約翰。

Thanks, Kevin.

謝謝你，凱文。

Before I get started I just want to say it's great to have you back on the Gilead team full time as our new Chief Operating Officer.

在正式開始之前，我只想說，非常高興您能全職回到吉利德團隊，擔任我們新的營運長。

Today in addition to the remarks of Robin and Kevin regarding the quarter, I'd like to make a few comments of my own. Over the last 2.5 years, we've made great progress in helping to provide access to Sovaldi and Harvoni for HCV patients. Throughout the world, more than 1 million HCV sufferers have now been treated, with nearly half of those coming from the US.

今天，除了 Robin 和 Kevin 對本季發表的評論之外，我也想發表幾點自己的看法。在過去的兩年半里，我們在幫助丙型肝炎患者獲得 Sovaldi 和 Harvoni 方面取得了巨大進展。目前全球已有超過100萬丙型肝炎患者接受了治療，其中近一半來自美國。

The launch of these drugs were unprecedented in our industry and patients were treated at a much faster initial rate than we or anyone else thought possible. Looking back, we can now say that in every country, the peak number of patients treated was achieved within two or three quarters of the launch of Harvoni and that peak number is far higher than what we had -- what had ever been achieved before, about three times that seen with the launch of the HCV protease inhibitors in 2011.

這些藥物的推出在我們行業中是前所未有的，患者的治療速度比我們或任何其他人預想的都要快得多。回顧過去，我們現在可以說，在每個國家，接受治療的患者人數峰值都在Harvoni上市後的兩到三個季度內達到，而且這個峰值遠遠高於我們以前所達到的水平，大約是2011年HCV蛋白酶抑製劑上市時的三倍。

As we reach the mid point of this year, we now see the market maturing to a slower rate of treatment for HCV-infected individuals. As we think about this more normal pace of patient starts, there are a few things to keep in mind.

今年已過半，我們看到C型肝炎病毒感染者的治療市場趨於成熟，治療速度也隨之放緩。當我們考慮這種更正常的病人就診節奏時，有幾件事需要牢記。

As Kevin mentioned, there are about 3 million people who are infected in the US and slightly more than half of those have been diagnosed. Many of these diagnosed patients have less-advanced liver disease upon reentering care. For example, in the United States in the second quarter this year, we estimated that only 13% of patient starting treatment had F4 fibrosis scores compared with more than 21% the year prior to that.

正如凱文所提到的，美國約有300萬人感染，其中略多於一半的人已確診。許多確診患者在重新接受治療時，肝病病情已減輕。例如，據我們估計，今年第二季度美國開始接受治療的患者中，只有 13% 的患者纖維化評分達到 F4，而前一年則超過 21%。

With less severely ill patients there's less urgency to immediately treat patients. This may explain the slower rate of treatment versus last year. However, we do believe these patients will eventually benefit from treatment and this means the flow of patients will continue for many years to come.

對於病情較輕的患者，無需立即進行治療。這或許可以解釋為什麼今年的治療速度比去年慢。但是，我們相信這些患者最終會從治療中受益，這意味著未來很多年裡，患者數量將持續成長。

There's also an opportunity to diagnose patients and bring them into care. As Kevin mentioned, we estimated that about 280,000 HCV patients were diagnosed in the US within the last two years, showing the value and importance of the US GDC and CMS recommendations for HCV testing. So while there's been a slowing of treatment compared with the rush of patients when Sovaldi and Harvoni were first approved, the HCV market is attractive over longer term, providing good revenues, strong cash flow and earnings per share on top of our base business of chronic therapies.

此外，還有機會診斷患者病情並進行治療。正如凱文所提到的，我們估計在過去兩年裡，美國約有 28 萬名 HCV 患者被診斷出患有 HCV，這表明美國 GDC 和 CMS 關於 HCV 檢測的建議具有價值和重要性。因此，雖然與 Sovaldi 和 Harvoni 首次獲批時患者蜂擁而至的情況相比，HCV 治療速度有所放緩，但從長遠來看，HCV 市場仍然具有吸引力，除了我們慢性病治療的基礎業務外，還能提供良好的收入、強勁的現金流和每股收益。

Because of this, our focus on improving share for HCV-infected individuals has not wavered. Beyond the recent approvals of Epclusa, we are actively working on a third single-tablet regimen that combines the two active ingredients in Epclusa with a third investigational compound, voxilaprevir. This combination, known as SOF/VEL/VOX, is being evaluated in four Phase III clinical trials among patients who have previously failed direct-acting antiviral treatments. It's also being studied for its potential to offer an eight-week treatment duration for treatment naive patients of all genotypes. We expect to have top-line data available for SOF/VEL/VOX by the end of the year.

正因如此，我們提高C型肝炎感染者市佔率的重點從未動搖。除了最近獲批的 Epclusa 之外，我們正在積極研發第三種單片療法，該療法將 Epclusa 中的兩種活性成分與第三種研究性化合物 voxilaprevir 相結合。這種名為 SOF/VEL/VOX 的組合療法正在四項 III 期臨床試驗中進行評估，受試者為先前接受直接抗病毒治療失敗的患者。目前也正在研究它是否有可能為所有基因型的初治患者提供為期八週的治療。我們預計今年底將有 SOF/VEL/VOX 的初步數據可供參考。

We're making tremendous headway in HIV as well, both in our portfolio of newer products and our pipeline. We've had several key approvals, with Descovy approved in the US and Europe last quarter and Odefsey approved in Europe earlier this month. It's clear these medicine offer a significant advance for patients and that advance has been recognized now by multiple professional and public health groups, including the International Antiviral Society of the USA and the Department of Health and Human Services, both of which released updated guidelines supporting the use of TAF-based regimens for initial HIV therapy.

我們在愛滋病領域也取得了巨大的進展，無論是在新產品組合方面，或是在研發管線方面。我們已經獲得了幾項關鍵批准，其中 Descovy 上季度在美國和歐洲獲得批准，Odefsey 本月早些時候在歐洲獲得批准。很明顯，這些藥物為患者帶來了重大進步，這一進步現在已得到包括美國國際抗病毒協會和美國衛生與公眾服務部在內的多個專業和公共衛生團體的認可，這兩個團體都發布了更新的指南，支持使用基於 TAF 的方案進行 HIV 初始治療。

We continue to generate clinical data that support the favorable scientific and medical profile of our TAF-based products. List week we announced the results of two Phase 3B switch studies evaluating Odefsey in virologically suppressed adults switching from Complera or Atripla. Odefsey achieved similar rates of virological suppression as the TDF-based regimens. These studies reinforce the efficacy of Odefsey, as well as the renal and bone safety advantages and we plan to present full data sets later this year.

我們不斷產生臨床數據，以支援我們基於 TAF 的產品的良好科學和醫學特性。本週我們公佈了兩項 3B 期轉換研究的結果，這些研究評估了 Odefsey 在病毒學抑制的成年患者中從 Complera 或 Atripla 轉換到 Odefsey 的療效。Odefsey 的病毒抑制率與基於 TDF 的治療方案相似。這些研究進一步證實了 Odefsey 的療效，以及其對腎臟和骨骼的安全性優勢，我們計劃在今年稍後公佈完整的數據集。

Last month we presented the first human data on Bictegravir, our investigational unboosted integrase inhibitor at the American Society for Microbiology. Data from four preclinical and Phase 1 studies examined the antiviral potency, resistance profile, pharmacokinetics and safety of Bictegravir, providing the rationale to further evaluate the compound. Bictegravir, as part of a single-tablet regimen in combination with TAF and emtricitabine, is currently in Phase 3 trials. Enrollment of more than 2,300 patients across four registration all studies was completed earlier this month.

上個月，我們在美國微生物學會上發表了比克替拉韋（Bictegravir）的首個人體數據，比克替拉韋是我們正在研究的非增強型整合酶抑制劑。來自四項臨床前和第 1 期研究的數據檢驗了比克替拉韋的抗病毒效力、抗藥性、藥物動力學和安全性，為進一步評估該化合物提供了理論基礎。比克替拉韋與 TAF 和恩曲他濱聯合使用，作為單片療法的一部分，目前正處於 3 期臨床試驗階段。本月初，四項註冊研究共招募了 2,300 多名患者。

The 48-week end points for these studies will be reached in the second quarter of next year and if the data play out as we hope, NDA and MAA filings could occur in the third quarter of 2017. With the approval and rapid adoption of our TAF-based regimens and exciting new SGR in Phase 3 development and an active HIV research pipeline, I'm confident that we will be able to extend our leadership position in the HIV market and broaden our ability to help even more patients around the world.

這些研究的 48 週終點將於明年第二季達到，如果數據如我們所願，NDA 和 MAA 申請可能會在 2017 年第三季提交。隨著我們基於 TAF 的治療方案獲得批准並迅速推廣應用，以及令人興奮的處於 3 期開發階段的新型 SGR，再加上我們積極的 HIV 研究管線，我相信我們將能夠鞏固我們在 HIV 市場的領先地位，並擴大我們幫助世界各地更多患者的能力。

Outside of or work in antivirals, Gilead is focused on solving some of the biggest health challenges today. Several important data sets that are anticipated the second half of this year may help us define a strategy and pathway forward for tackling these challenges. In our ASK program, where we have four active clinical programs, we'll have data from the Phase 2 studies of GS-4997, our ASK-1 inhibitor, and Simtuzumab, our monoclonal antibody against [Waksel] 2. The Phase 2 study of Simtuzumab for primary sclerosing cholangitis owing will also conclude and we will also have data from the Phase 2 studies of GS-4997 in diabetic nephropathy and pulmonary arterial hypertension, or PAH. Finally, we expect data from two Phase 3 studies of Momelotinib for myelofibrosis before the end of the year. If these data are positive these studies will form the basis for an NDA filing in the first quarter of 2017.

除了抗病毒藥物研發之外，吉利德還致力於解決當今一些最大的健康挑戰。今年下半年預計將公佈的幾組重要數據集可能有助於我們制定應對這些挑戰的策略和前進方向。在我們的 ASK 計畫中，我們有四個活躍的臨床項目，我們將發表 ASK-1 抑制劑 GS-4997 和抗 [Waksel] 2 單株抗體 Simtuzumab 的 II 期研究數據。 Simtuzumab 治療原發性硬化性膽管炎的 II 期研究也將結束，我們也將發表 GS-4997 治療糖尿病腎病變和肺動脈高壓 (PAH) 的 II 期研究數據。最後，我們預計在年底前將獲得兩項針對骨髓纖維化的Momelotinib 3期研究的數據。如果這些數據是正面的，這些研究將成為 2017 年第一季提交 NDA 申請的基礎。

These are important milestones and represent a great deal of work across the organization to enroll and advance these studies and analyze complex data sets as they become available. Gilead continues to innovate at every level and every part of the organization. Next month, we will publish our first corporate social responsibility report that looks at assets, sustainability, grant making and other positive contributions to the communities we serve and I urge you to read it. I'm proud of the work that's being lead by our employees and extend my many thanks to them for all of the ways they are making a difference around the world.

這些都是重要的里程碑，代表著整個組織為招募和推進這些研究以及分析不斷湧現的複雜數據集所付出的巨大努力。吉利德在組織的各個層面和各個部門持續進行創新。下個月，我們將發布第一份企業社會責任報告，該報告著眼於資產、永續性、捐贈以及對我們所服務社區的其他積極貢獻，我敦促您閱讀該報告。我為我們員工所做的工作感到自豪，並衷心感謝他們以各種方式在世界各地做出貢獻。

Thank you and let's now open up the call for questions. Operator?

謝謝大家，現在我們開始接受提問。操作員？

(Operator Instructions)

（操作說明）

Our first question comes from the line of Geoff Meacham of Barclays.

我們的第一個問題來自巴克萊銀行的傑夫·米查姆。

Afternoon, guys. Thanks for taking the question. Kevin good to have you back on the call and in the seat, of course. I want to dig into your comments and also John's comments on the help C new starts. I guess I'm curious here because you have better F-0, F-1 access, you have positive impact theoretically from the CDC guidelines and very low penetration in markets such as the prison population. I'm curious why -- could you put your finger on one or two things that you feel like could ultimately become a growth driver to get us back to better sequential growth? I'm just trying to figure out what the tipping point is on some of these different volume drivers. Thanks.

下午好，各位。感謝您回答這個問題。凱文，很高興你回到電話會議和職位。我想深入研究一下你的評論，以及約翰關於幫助 C 新開始的評論。我之所以好奇，是因為你們更容易獲得 F-0、F-1 簽證，從理論上講，你們會受到疾管中心指導方針的正面影響，但在監獄人口等市場中的滲透率卻很低。我很好奇原因－您能否指出一兩件您認為最終可能成為成長驅動力，使我們恢復到更好連續成長的因素？我只是想弄清楚這些不同音量驅動裝置的臨界點是什麼。謝謝。

Geoff, nice to hear your voice as well. Thank you for your comments. I'm not at all pessimistic about the long-term prospects for hepatitis C. In fact, I'm rather optimistic. I think what we have seen 2014, 2015, is an enormous group of the less-well patients treated, particularly by specialist hepatitis C treaters. It's really quite amazing.

傑夫，很高興聽到你的聲音。感謝您的評論。我對丙型肝炎的長期前景一點也不悲觀。事實上，我相當樂觀。我認為我們在 2014 年、2015 年看到的是一大批病情較重的患者得到了治療，特別是由丙型肝炎專科醫生治療的患者。真是太神奇了。

I think that this quarter, and we highlighted perhaps going forward, is really sort of a payer mix situation that we've got. The VA is definitely increased in terms of its contribution to the 59,000 total HCV starts, which of course was an increase on quarter one. A lot of VA patients are coming through and the VA is very, very motivated to try to essentially eradicate the virus from that population. I think yes, we did see pick up in two of the large payers that came on stream with open fibrosis scores from the beginning of the year, but we did see some down tick in other commercial payers, so net-net it was slightly a decrease in overall commercial patients.

我認為本季度，以及我們先前強調的可能在未來一段時間內，我們面臨的確實是一種支付方組合情況。退伍軍人事務部 (VA) 對 59,000 例 HCV 啟動總數的貢獻肯定有所增加，這當然比第一季有所增加。許多退伍軍人事務部 (VA) 的患者前來就診，VA 也非常積極地想要徹底根除該族群的病毒。我認為是的，我們確實看到年初開始採用開放式纖維化評分的兩家大型支付方有所回升，但我們也看到其他商業支付方有所下降，因此總體而言，商業患者數量略有減少。

What I feel about the long term and as we go into years further forward and we find of hit an equilibrium of patients is all around what I mentioned and John mentioned around diagnosis. There's been a considerable pick up in the number of HCV tests. 2014 and 2015, about a 65% increase in the number of HCV tests. 280,000 in that two-year where HCV RNA positive. So as John said, they will eventually work their way through to treatment. There's still over a quarter of the population being diagnosed [is at four], so there's still a lot of sickness out there in patients. Whilst the healthcare system here and in some of the European markets have done heroic things in treating patients in the last two years, I still think with 1.5 million diagnosed patients in the United States that we are going to see a continued healthy flow of patients that can benefit from our products.

從長遠來看，隨著時間推移，當我們最終達到患者數量的平衡時，我的感覺是，這都與我和約翰提到的診斷問題有關。丙型肝炎病毒檢測數量大幅增加。2014 年和 2015 年，丙型肝炎病毒檢測數量增加了約 65%。兩年內有 28 萬例 HCV RNA 檢測呈陽性。正如約翰所說，他們最終會接受治療的。仍有超過四分之一的人口被診斷出患有此病（目前為 4%），所以還有很多病人患病。雖然在過去兩年裡，美國和一些歐洲市場的醫療保健系統在治療患者方面取得了巨大的成就，但我仍然認為，美國有 150 萬確診患者，我們將繼續看到源源不斷的健康患者群體，他們將從我們的產品中受益。

Okay. Thanks, Kevin.

好的。謝謝你，凱文。

Thank you. Our next question comes from Geoffrey Porges of Leerink.

謝謝。我們的下一個問題來自 Leerink 公司的 Geoffrey Porges。

Thanks very much. For Kevin, welcome back and good to hear you. Following up on this somewhat vexing issue of the HCV outlook, historically in this category after each market has peaked, it's begun a steady, slow, sometimes slow anyway, decline. We certainly saw a rapid decline after the protease inhibitors, more slow decline after we went to Ribavirin and with the introduction of pegylated interferon. Are you suggesting to us that you think that there's a stable outlook for the HCV revenue on a market-by-market basis from these levels or are you suggesting that we should see more like an orderly and steady decline? Could you particularly comment about Europe where I think it was surprising to see patient numbers in the big early markets roll over so quickly, particularly Germany and Japan. Is that a one-time step down or are we going to continue at or below this level going forward?

非常感謝。凱文，歡迎回來，很高興聽到你的聲音。關於丙型肝炎病毒（HCV）前景這一令人有些困擾的問題，從歷史上看，這類病毒在每個市場達到頂峰後，就開始了穩定、緩慢（有時至少是緩慢的）下降。蛋白酶抑制劑的使用確實導致了病情的迅速惡化，而利巴韋林的使用和聚乙二醇幹擾素的引入則導致了病情的緩慢惡化。你是說你認為從目前的水平來看，HCV 收入在各個市場都保持穩定，還是說你應該看到更明顯的有序和穩定下降？能否特別談談歐洲的情況？我認為，在早期主要市場（尤其是德國和日本）看到患者數量迅速下降，著實令人驚訝。這是一次性的降級，還是未來會一直維持在這個水準或更低？

Yes, thanks for the question, Geoff. I think it is encouraging that patient starts in the US and Europe have been reasonably steady over the past three quarters. Japan is a different story I can certainly at some point comment on that this afternoon. I think from my perspective and Robin (inaudible) John around the table here, I think it's more of the latter comment that they will continue to be a gradual decline in new patient starts but an equilibrium will be eventually hit. Quite the timing of that, Geoff, it's really, really, really hard to peg. I've just got to believe that with the amount of testing, with the amount of diagnosis, with the CDC guidelines Gilead itself in Q3, Q4 of this year are going to do some more educational programs around the need to test and treat. That -- we will eventually hit an equilibrium.

是的，謝謝你的提問，傑夫。我認為令人鼓舞的是，過去三個季度美國和歐洲的患者數量一直保持相對穩定。日本的情況則有所不同，我今天下午一定會找時間對此發表評論。我認為，從我和羅賓（聽不清楚）約翰的角度來看，我認為後一種說法更為合理，即新患者數量將繼續逐漸下降，但最終會達到平衡。傑夫，這時間點真是太巧了，真的很難說清楚。我堅信，隨著檢測量的增加、診斷量的提高以及疾管中心指南的出台，吉利德公司將在今年第三季和第四季開展更多關於檢測和治療必要性的教育計畫。最終我們會達到平衡狀態。

In terms of Europe, Italy and Spain are very steady. I should tell you that in Italy there are still 200,000 quite sick individuals, people to be treated and they are in treated care and the Italian government do want to go ahead and try and mobilize providers to do that treatment, so it's still an enormous number in Italy. I think the markets that are more akin to the US, like first and foremost Germany and to a slightly less extent France, are starting to see that turn over of patients. We've got full access in terms of fibrosis, though, in Germany and we're hoping, as I said, that we get broader sets in France. The UK is a different situation and that's largely due to payer restrictions. But again, still an enthusiasm to treat but one of two of those markets, there is some maturing going on.

就歐洲而言，義大利和西班牙的經濟狀況非常穩定。我應該告訴你們，義大利仍有 20 萬名重症患者需要治療，他們正在接受治療護理，義大利政府也希望繼續努力調動醫療服務提供者來進行治療，所以義大利的病人數量仍然非常龐大。我認為那些與美國更相似的市場，首先是德國，其次是法國，已經開始出現患者更替的情況。不過，在德國，我們已經獲得了纖維化方面的全面資源，正如我所說，我們希望在法國也能獲得更廣泛的資源。英國的情況有所不同，這主要是由於支付方的限制。但話說回來，儘管對其中一兩個市場仍抱持熱情，但市場正逐漸成熟。

Thanks very much.

非常感謝。

Thank you. Our next question comes from Mark Schoenebaum of Evercore ISI.

謝謝。我們的下一個問題來自 Evercore ISI 的 Mark Schoenebaum。

Hi. Good afternoon. Thank you for taking my call. This is Regina Greville in for Mark. I actually wanted to change topics and shift to hepatitis B. On your Q1 call you mentioned your hep B program included the vaccine, the TLR7 agnoist and two other internal preclinical candidates. When will we see any data on the internal candidates? Also, you mentioned taking a look at external opportunities for hepatitis B. Is hep B a still potential area for acquisition? Thank you.

你好。午安.謝謝你接聽我的電話。這是雷吉娜·格雷維爾，她代替馬克上場。我其實想換個話題，聊聊B肝。你在第一季財報電話會議上提到，你們的B型肝炎計畫包括疫苗、TLR7非標靶藥物以及另外兩個內部臨床前候選藥物。我們什麼時候才能看到有關內部候選人的數據？另外，您提到要關注B型肝炎領域的外部收購機會。乙肝領域現在仍然是潛在的收購目標嗎？謝謝。

You asked the question about what our pipeline is for hepatitis B. We have, as you know, two compound drugs currently in clinical development. One is an active vaccine, 4779, a collaboration is with GlobeImmune. That's currently in the later stages of being evaluated (inaudible) those data has been released a year ago, that did not show any activity, so we don't have high hopes that this compound will work. Then the TLR7 agnoist is just finishing the first cohort, which is in suppress stations and we are currently initiating the second cohort is ongoing. We hope that we'll have the presentation (inaudible). Hopefully it will make the abstract deadline.

您問到了我們針對B肝的研發管線。如您所知，我們目前有兩種化合物藥物正在進行臨床開發。其中一款是活性疫苗，型號為 4779，是與 GlobeImmune 合作研發的。目前該化合物正處於評估的後期階段（聽不清楚），相關數據已於一年前發布，但並未顯示任何活性，因此我們對該化合物的療效並不抱太大希望。然後，TLR7 未知者剛完成第一批，目前處於抑制狀態，我們正在啟動第二批，目前正在進行中。我們希望能夠進行演示（聽不清楚）。希望它能趕上摘要的截止日期。

Then you said -- you asked the question about we have two other compounds in development. Well, you know that we're pursuing, maybe I should answer this more generally. We're pursuing three approaches to hepatitis B cure. The one is adding another different mechanism to the nucleotide because there is the observation that despite being undetectable, with hepatitis B therapies like (inaudible), there was always a little bit of virus left (inaudible) detectible if you look at very sensitive PCR methods. By adding another mechanism (inaudible) completely suppressed virus (inaudible) out to zero, would that lead to an eventual cure or hepatitis S conversion.

然後你說——你問了關於我們還有兩種化合物正在研發的問題。嗯，你知道我們正在調查此事，或許我應該更籠統地回答這個問題。我們正在探索三種治療B肝的方法。其中之一是在核苷酸中添加另一種不同的機制，因為觀察到，儘管乙肝療法（聽不清楚）檢測不到病毒，但總有一些病毒殘留（聽不清楚），如果使用非常靈敏的 PCR 方法檢測，就能發現。透過添加另一種機制（聽不清楚）完全抑制病毒（聽不清楚）至零，這是否會導致最終治癒或甲型肝炎轉化？

The second thing we're pursuing is immune therapy, so that belongs to vaccine and to TLR7 that I talked about already. We have a TLR8 agnoist currently that is working its way towards IND. Then the third possibility that's the most hopeful but also the one that is least scientifically proven is going directly CCC DNA and that is really too early to talk about at this point. It's still in the research stages.

我們正在研究的第二件事是免疫療法，這涉及疫苗和我之前提到的 TLR7。我們目前有一個 TLR8 不可知論者，正在努力朝著 IND 邁進。第三種可能性是最有希望的，但也是科學上最缺乏證明的，那就是直接使用 CCC DNA，但現在談論這件事還為時過早。目前仍處於研究階段。

Thank you. Our next question comes from Michael Yee of RBC Capital Markets.

謝謝。下一個問題來自加拿大皇家銀行資本市場的Michael Yee。

Hey, guys. Thanks for the question. You talked a lot about falling demand in the different buckets but can you talk about the payer mix shift? Specifically, I wanted to ask on Medicaid. Can you just help us out with what percent of sales Medicaid is and what is going on in that bucket? I presume it's a state-by-state negotiation. Can you talk about what's going on there, is there a state-by-state negotiation you have to go through? Is that pretty much done? Walk us through that bucket and what percent of hep C that is in the USA so I can understand that. Thank you so much.

嘿，夥計們。謝謝你的提問。您多次談到不同領域的需求下降，但您能談談支付方結構的變化嗎？具體來說，我想諮詢一下醫療補助計劃（Medicaid）。您能幫我們統計一下醫療補助（Medicaid）的銷售額佔比是多少，以及這部分銷售額的具體情況嗎？我估計這是各州之間逐一談判的結果。你能談談那裡的情況嗎？是不是需要逐州進行談判？差不多完成了嗎？請您詳細解釋一下這個桶子裡裝的是什麼，以及它在美國C肝病例中所佔的百分比，這樣我才能理解。太感謝了。

Hi, Michael, it's Kevin. Thank you for the question. I'd prefer not to break out specifically the percentage of the public payers in terms of Medicaid. As I said, all our public payers lumped together for the quarter were about 45%. That's an increase from the previous quarter but as I said, that's all driven by VA. We see very little change really in the scale and size of our Medicaid business. I think it would be true to say that Medicaid, the states are slowly progressively opening up.

嗨，邁克爾，我是凱文。謝謝你的提問。我不想具體列出醫療補助計劃中公共支付者所佔的百分比。正如我所說，本季所有公共繳費者加起來約佔 45%。這比上一季有所增長，但正如我所說，這完全是由退伍軍人事務部推動的。我們看到，醫療補助業務的規模和體積其實並沒有太大變化。我認為可以說，各州正在逐步開放醫療補助計劃。

40% Medicaid patients come from the five largest states. Two of those, New York and Florida, now have no fibrosis score, so as states do progressively consider opening up, they typically come to us for a contract. We think about those contracts very carefully. Depending on the size of Medicaid, we obviously put our submission in. Realistically, I think we may win, we hope, the majority of those but there may be occasions when occasionally a Medicaid state goes to the competition.

40%的醫療補助患者來自五個最大的州。紐約州和佛羅裡達州目前都沒有纖維化評分，因此隨著各州逐步考慮開放，他們通常會來找我們簽約。我們會非常仔細地考慮這些合約。根據醫療補助計劃的規模，我們顯然會提交申請。現實地說，我認為我們可能會贏得大多數，我們希望如此，但偶爾也可能出現某個醫療補助州參與競爭的情況。

Thank you.

謝謝。

Thank you. Our next question comes from Matthew Harrison of Morgan Stanley.

謝謝。下一個問題來自摩根士丹利的馬修·哈里森。

Great. Thanks so much for taking the question. Robin, if you could just address the $279 million one-time swing, we obviously saw a swing in the first quarter and then a swing this quarter again. Can you just give us some inside into what's going on with those changes in chargebacks and if we should continue to expect to see some of those numbers? Separately on PrEP, any plans to get a TAF-based regimen approved for PrEP? Thanks.

偉大的。非常感謝您回答這個問題。羅賓，如果你能解釋一下那 2.79 億美元的一次性波動，我們顯然在第一季看到了波動，然後本季又看到了波動。您能否簡要介紹一下拒付率變化的具體情況，以及我們是否會繼續看到這些數字的變化？另外，關於PrEP，是否有計劃批准基於TAF的方案用於PrEP？謝謝。

Sure, I'll take the first part and then Norbert will take the second. Matt, first of all there's two separate things that we're talking about here Q2 versus Q1. First let me address Q2. We did have a sales return reserve adjustment related to the fact that as we introduced our new hep C product we were required to go out and get an external proxy related to sales return reserves. Just recently, just this past quarter we closed several of the lots related to our products which means that no further returns are accepted. So that is the triggering event by which we can look at returns versus how we had been accruing.

當然，我來做第一部分，然後諾伯特來做第二部分。馬特，首先，我們在這裡討論的是兩件不同的事情：Q2 與 Q1。首先讓我回答第二個問題。由於我們推出了新的C肝產品，因此需要找外部代理機構來處理銷售退貨準備金，所以我們確實進行了銷售退貨準備金調整。就在最近，就在上個季度，我們關閉了與我們產品相關的幾個批次，這意味著不再接受退貨。所以，這就是我們可以查看收益與我們之前累積情況的觸發事件。

The other key thing about the timing of this related to the Epclusa launch. As you bring on a new product we want to kind of re-base the level of returns that we expected see. So that's really the adjustment there. For the most part, you can see it's one-time in nature. We may have small adjustments going forward but as long as we returns continue where they are than that $279 million is kind of a one-time event.

這件事發生的時間點還有另一個關鍵因素，那就是與 Epclusa 的發布有關。隨著新產品的推出，我們希望重新調整預期收益水準。所以，這才是真正需要調整的地方。大多數情況下，你可以看出這是自然界中一次性的現象。未來我們可能會做一些小的調整，但只要收益繼續保持目前的水平，那麼這 2.79 億美元的損失就只是一次性事件。

Last quarter we had a different issue and that related to rebate claims for hepatitis C. AS I said on the call last time, we always have a situation where we are constantly churning up claims around HCV rebate because you get those claims one to two quarters in arrears. This quarter was a bit different than last quarter in that we saw a modernization of the level of those claims relative to the prior quarter so it wasn't -- it didn't' reversed the other way. It was just (inaudible) of what we saw in Q1. We're, for lack of better word, maybe a little bit more caught up relative to returns this quarter than we were at the end of Q1. So two different items but we called out the $279 million but that was the one-time event but we wanted to insure you understand relative to the future projection of HCV sales.

上個季度我們遇到了另一個問題，那就是C型肝炎的退款申請。正如我上次在電話會議上所說，我們總是會遇到丙型肝炎退款申請不斷湧現的情況，因為這些申請通常會落後一到兩個季度。本季度與上個季度略有不同，我們看到這些索賠的水平相對於上個季度有所提高，所以情況並沒有——並沒有朝著相反的方向發展。就像我們在第一季看到的（聽不清楚）。恕我直言，與第一季末相比，我們本季的回報情況可能略有改善。所以這是兩件不同的事，我們提到了 2.79 億美元，但那是一次性事件，我們想確保您理解它與 HCV 銷售的未來預測之間的關係。

(Multiple speakers) We also have outside medical community they (inaudible) They have advantages in terms of use for PrEP versus (inaudible) either that were published already and we have data now in human -- in animal models that show that it has the same efficacy. The thing we're debating in terms of (inaudible) early discussions with the FDA is what clinical study would need to be done that leads to approval? It would have to be, in almost all likelihood, a comparative study (inaudible) of what would be the sample size and would be the powering and that's currently in discussion we're having with FDA. We hope we can come to some conclusion within the next month or so (inaudible).

（多位發言者）我們也有外部醫學界人士，他們（聽不清楚）在 PrEP 的使用方面具有優勢，與（聽不清楚）相比，這些優勢已經發表，我們現在也有人體和動物模型的數據表明它具有相同的療效。我們正在與FDA進行（聽不清楚）早期討論的問題是，需要進行什麼樣的臨床研究才能獲得批准？幾乎可以肯定的是，這將是一項比較研究（聽不清楚），研究樣本量和統計功效，而這正是我們目前正在與 FDA 討論的問題。我們希望在接下來的一個月左右能夠得出一些結論（聽不清楚）。

Great, thank you.

太好了，謝謝。

Thank you. Our next question comes from Brian Abrahams with Jefferies.

謝謝。下一個問題來自傑富瑞集團的布萊恩亞伯拉罕。

Hi. Thanks for taking my question and Kevin, good to hear your voice again. With the list pricing and label established for Epclusa, just wondering what's the right way to think about Epclusa's potential impact on the genotype 2/3 franchise, particularly with respect to the net price per patient, treatment duration relative to Sovaldi and how we should be thinking about the overall market dynamics. Just wondering if you could also quantify the inventory build this quarter in there. Thanks.

你好。謝謝您回答我的問題，凱文，很高興再次聽到你的聲音。Epclusa 的定價和標籤已經確定，我想知道如何正確地思考 Epclusa 對 2/3 型基因型藥物的潛在影響，特別是關於每位患者的淨價格、相對於 Sovaldi 的治療持續時間以及我們應該如何看待整體市場動態。我想知道您是否也能把本季的庫存增加量量化一下。謝謝。

Great question, Brian. Nice to hear your voice as well. The majority of the revenues in the second quarter, which is right at the end, the majority of that was inventory that Robin called out. We've really only just begun the introduction, both the promotion and the education around Epclusa. I'm really pleased the response has been excellent and our advisory boards and our speaker programs has been good acceptance. Whilst we have obviously a pan-genotypic label, I think the reality is that physicians are very, very comfortable, as are payers, with Harvoni for genotype 1.

問得好，布萊恩。很高興聽到你的聲音。第二季（也就是季度末）的大部分收入都是羅賓提到的庫存。我們才剛開始介紹、推廣和普及 Epclusa 相關知識。我非常高興大家的反應如此熱烈，我們的顧問委員會和演講者計畫也得到了很好的認可。雖然我們顯然有一個泛基因型標籤，但我認為現實情況是，醫生和支付方都對 Harvoni 用於基因型 1 非常非常滿意。

Obviously, there's a mix of 12-week treatment and 8-week. Just for your information, the eight-week course with Harvoni is now 45% of patients treated in the United States. I think people are just really comfortable with the clinical effect and the value proposition of Harvoni in GT1, which therefore means that the slot that people see Epclusa is in the 2 and 3 patient. As I highlighted, it's something like in the order of 20% to 25% of patients in United States. I think the obvious advantage, both clinically and from a payer point of view, is you really do have a 12-week single-tablet regimen. You don't have to extend the treatment duration. You don't have to use Ribavirin. It was quite the number of patients treated with Sovaldi (inaudible), certainly in the United States, so really in some ways it takes away that regimen and is an excellent slot.

顯然，治療方案包括 12 週療程和 8 週療程兩種。僅供參考，目前美國有 45% 的患者接受了 Harvoni 的八週療程治療。我認為人們對 Harvoni 在 GT1 中的臨床效果和價值主張感到非常滿意，因此，人們看到 Epclusa 的位置是在第二代和第三代患者中。正如我所強調的那樣，這大約占美國患者的 20% 到 25%。我認為，無論從臨床角度還是從支付方角度來看，顯而易見的優勢在於，你確實可以採用 12 週的單片療法。您無需延長治療時間。你不需要使用利巴韋林。接受 Sovaldi 治療的患者人數相當多（聽不清楚），尤其是在美國，所以從某種程度上來說，它取代了先前的治療方案，是一個很好的選擇。

We've had very good reception to Epclusa. It's extremely early days. It will take us three to six months to get payer approval. Physicians can apply based on medical need and we know they're doing that, so just very early days and weeks. It seems to have found a very nice entry point.

Epclusa 的反應非常好。現在下結論還為時過早。我們需要三到六個月的時間才能獲得付款方的批准。醫生可以根據醫療需求提出申請，我們知道他們正在這樣做，所以這只是非常早期的幾天和幾週時間。它似乎找到了一個非常好的切入點。

Thanks.

謝謝。

Thank you. And our next question comes from the line of Cory Kasimov of JPMorgan.

謝謝。我們的下一個問題來自摩根大通的科里·卡西莫夫。

Good afternoon, guys. Thank you for taking my question. I have a bigger picture question for you. Really just following the latest management shuffle back in Q2, I'm wondering if these changes portend any material shift or consideration of a shift in, I guess, your commercial or pricing strategy or really the overall strategy for the business or any of the key businesses? Is this playing into the bump in anticipated R&D with the associated downtick in SG&A as illustrated by your updated guidance? Thanks.

下午好，各位。感謝您回答我的問題。我還有一個更宏觀的問題想問你。鑑於第二季度最近的管理層調整，我想知道這些變化是否預示著貴公司在商業或定價策略，或者說整體業務戰略，或者任何關鍵業務戰略方面，將會發生任何實質性的轉變或考慮進行調整？正如您更新後的業績指引所示，這是否與預期研發投入的成長以及相應的銷售、管理及行政費用下降相符？謝謝。

I think there were a couple questions there. It's John Martin. In terms of -- let me get to the last bit. You said a bump in R&D. That is true relating somewhat to our acquisition of Nimbus, so there were charges associated with that and there were also charges associated -- I should say expenses associated with the purchase of a FDA priority review voucher. We were very pleased to get that on board and we'll look forward to explaining when we are going to use that. Above and beyond that, actually R&D expenses are slightly down beneath what we had forecasted because we continue to hold the cost centers to accountable and continue to drive good value through our clinical teams and getting studies done at a very cost effective way. In terms of that, there's no difference.

我覺得那裡應該有幾個問題。他是約翰·馬丁。關於——讓我再說最後一點。你說研發投入有增加。這與我們收購 Nimbus 的情況有些關係，因此會產生一些費用，此外，購買 FDA 優先審查憑證也會產生一些費用——應該說是支出。我們很高興能採納這項建議，並期待在何時使用它時向大家解釋。除此之外，研發費用實際上略低於我們的預期，因為我們繼續對成本中心進行問責，並透過我們的臨床團隊繼續創造良好的價值，並以非常經濟高效的方式完成研究。就這一點而言，沒有區別。

The SG&A line came down a little bit because of some one-time charges that were lower than we -- sorry, the IRS charges was lower than we anticipated so kind of what we would expect. In terms of signaling about pricing or changes in management about structures, I don't think there's anything to signal there in terms of our pricing strategy. We're highly competitive. We think we have a very good differentiated product and we'll continue to do the best for the Company and for patients by coming to the right level of price and access.

銷售、一般及行政費用略有下降，因為一些一次性費用低於我們的預期——抱歉，是國稅局的費用低於我們的預期，這也在我們的預料之中。就定價訊號或管理層結構變化而言，我認為就我們的定價策略而言，沒有什麼需要發出的信號。我們極具競爭力。我們認為我們擁有非常優秀的差異化產品，我們將繼續努力，透過合理的價格和便利的取得途徑，為公司和患者做到最好。

I'd just add, Cory, that the Gilead way is always to lead with the science around our products. Nothing has changed in my eyes as I've come back into the Company. We lead with science. That's what you do in specialist markets. It is a reality that there is no contracting. I think we've got a phenomenal team working on this. I met with them two weeks ago and I think they are highly professional. We always lead with value. That's the key thing. We think we've got tremendous products that either control disease or cure disease and they have terrific value and that's the course we are going to stay.

科里，我還要補充一點，吉利德的做法始終是以我們產品的科學性為先導。自從我回到公司以來，在我看來一切都沒有改變。我們以科學為先導。在專業市場中，你就是這麼做的。現實情況是，不存在任何契約。我認為我們有一個非常優秀的團隊在做這件事。我兩週前見過他們，我認為他們非常專業。我們始終以價值為先。這是關鍵所在。我們認為我們擁有能夠控制疾病或治癒疾病的卓越產品，它們具有巨大的價值，我們將堅持走這條路。

Thank you.

謝謝。

Thank you. Our next question comes from Phil Nadeau of Cowen.

謝謝。我們的下一個問題來自 Cowen 公司的 Phil Nadeau。

Good evening. Thanks for taking my question and Kevin, it's great to have you back. I have a question on capital allocation. In the prepared remarks, I think you mentioned in regards to cash flows being lower in the second half of the year that part of that was investment in R&D. As you just discussed, R&D expenses aren't really changing that much in the guidance, so kind of curious whether you have on your list of things to do in the second half of the year more deals, whether M&A or in licensing and maybe you could give us some thoughts on how aggressive you are likely to be in those areas.

晚安.謝謝你回答我的問題，凱文，很高興你回來。我有一個關於資本配置的問題。在準備好的演講稿中，我認為您提到了下半年現金流減少的部分原因是研發投資。正如您剛才所討論的，研發支出在指導意見中並沒有太大變化，所以我很好奇，在今年下半年，您是否計劃進行更多交易，無論是併購還是許可，也許您可以談談您在這些領域可能會採取多積極的行動。

I'll start. I think relative to the cash flow, what I was messaging was really related to the dynamics of payments, right? We have accrued rebates and other things that cause volatility to quarterly cash flows. Overall on cash flows (inaudible) but we definitely expect a sequential decrease in cash flows second half. Relative to our overall capital allocation, its no different than what we've been messaging. Again, more focus on our B&D opportunities, which I'll let John speak of a little bit more and again, focus there and that additional focus was somewhat less focused on share repurchases in the second half of the year.

我先來。我認為相對於現金流而言，我所傳達的訊息實際上與支付動態有關，對吧？我們有累積的退款和其他因素，這些因素會導致季度現金流波動。總體而言，現金流（聽不清楚），但我們肯定預計下半年現金流將環比下降。就我們的整體資本配置而言，這與我們一直以來傳達的訊息並無不同。再次強調，我們將更加關注我們的收購和發展機會，這方面我讓約翰再多談談。再次強調，我們將重點放在這方面，而下半年我們對股票回購的關注度則有所降低。

To follow-up on what Robin said, so we were very aggressive in the first quarter of that year. That's why we've backed off a little bit from where we are in the second half of this year. Mostly you get the full year effect or a greater effect of repurchasing the almost 100 million shares through Robin's program. With regard to business development, obviously that is a Company that has been very open about being interested in doing more deals, especially deals of a certain size where we think we can get some leverage and we can use our organization to effectively accelerate or expand indications. We've done good deals both with Gallapagos and Nimbus recently. We are very interested in continuing to add more things to our pipeline, especially in the non-antiviral area where we continue to see growth in franchises. It's our hope as we exit this year we'll have a better, more complete story of programs internally and externally that we can use to talk about why the long-term prospects for growth are as good as we believe they are and that's what we will be focused on.

正如羅賓所說，我們在那年的第一季採取了非常積極的策略。這就是為什麼我們在今年下半年稍微放慢了腳步的原因。通常情況下，你會獲得全年效果，或透過 Robin 的計畫回購近 1 億股股票，獲得更大的效果。就業務發展而言，顯然，該公司一直非常公開地表示有興趣達成更多交易，尤其是一些我們認為可以獲得一定籌碼並利用我們組織有效加速或擴大適應症規模的交易。我們最近與 Gallapagos 和 Nimbus 都達成了不錯的交易。我們非常有興趣繼續在我們的產品線中添加更多產品，尤其是在非抗病毒領域，我們看到特許經營業務在該領域持續成長。我們希望在今年結束之際，能夠對公司內部和外部的專案有一個更好、更完整的了解，以便我們能夠闡述為什麼我們認為公司的長期成長前景如此樂觀，而這正是我們將要關注的重點。

Thanks for taking my questions.

謝謝您回答我的問題。

Thank you. Our next question comes from Robyn Karnauskas of Citi.

謝謝。下一個問題來自花旗銀行的 Robyn Karnauskas。

Hi, guys. Thanks for taking my questions. I guess the question after hearing some of the comments about thinking about volumes slowing or coming down and then thinking about growth and that changing over time, how do you -- how are you comfortable that you can provide guidance with these two variables? Do you have any bookends for how low we can go that give you the comfort. Then the question is, you affirmed guidance last quarter and lowered it this quarter. What was the one thing you think that really changed your view over the last three months that lead to that? Thanks.

嗨，大家好。謝謝您回答我的問題。我想，在聽到一些關於交易量放緩或下降以及成長隨時間變化的評論之後，問題在於——您如何才能自信地在考慮這兩個變數時提供指導？你們有沒有想過，我們能把價格降到多低才能讓你們感到舒適？那麼問題來了，你們上季維持了業績預期，而這季度卻下調了預期。在過去三個月裡，是什麼事情真正改變了你的看法，導致了現在這個結果？謝謝。

I'll start and then hand across to Robin. Robyn, it's really hard. We've got markets in different stages of development, whether it be US, parts of the US, different countries in Europe and obviously interesting, profound dynamics in Japan. They're partly made up of patient flows and partly made up of sort of payer flows. I think the big thing this quarter from the point of view of the US was very much a payer mix with the large addition of patients from the VA. I think in the last three months that was probably the biggest thing. We have not changed our prices in the US, Q2 versus Q1. It was largely we're seeing this dramatic but incredibly successful program from VA.

我先開始，然後交給羅賓。羅賓，這真的很難。我們有處於不同發展階段的市場，無論是美國、美國部分地區、歐洲不同國家，當然還有日本，那裡有著有趣而深刻的動態。它們一部分由患者流量構成，一部分由某種支付方流量構成。我認為從美國的角度來看，本季最大的變化是支付方組成發生了顯著變化，退伍軍人事務部 (VA) 的患者數量大幅增加。我認為在過去三個月裡，這可能是最重要的事情。我們在美國的價格沒有變化，第二季與第一季相比沒有變化。我們看到的主要是退伍軍人事務部這項意義重大但又極其成功的計劃。

I agree with Kevin. I think the heavier percentage of more discounted payers, along with the fact that on the commercial side, we're seeing slight increases in US and Kevin mentioned earlier about what we are also seeing relative to the mix shift in countries in Europe. Less of Northern Europe, Germany and France and more of Italy than Spain. The other part of your question is (inaudible) throughout the call, this is a really difficult area to predict. It's unlike any other. It's a curative market and it's very large, so (inaudible) total revenues. It's a question we ask in ourselves as we think in outer years how can we continue or can we really guide around each of these revenues. We've guided this year but it's definitely something we're giving a lot of thought to as we kind of think about the trends of HCV going forward and all of the dynamics that we're trying to deal with. It's very complex so more to follow on that.

我同意凱文的觀點。我認為，折扣支付者的比例較高，加上商業方面，我們看到美國略有成長，凱文之前也提到過，歐洲各國的組成也發生了變化。北歐、德國和法國的成分較少，義大利的成分較多，而西班牙的成分較少。你問題的另一部分是（聽不清楚）在整個通話過程中，這是一個很難預測的領域。它與眾不同。這是一個治療市場，而且市場規模非常大，所以（聽不清楚）總收入。這是一個我們在思考未來幾年如何繼續或如何真正圍繞每項收入進行規劃時都會問自己的問題。今年我們已經制定了指導方針，但隨著我們對丙型肝炎病毒未來發展趨勢以及我們正在努力應對的所有動態進行思考，這絕對是我們正在認真考慮的事情。這非常複雜，後續會有更多相關內容。

Great, thank you.

太好了，謝謝。

Thank you our next question comes from Ying Huang of Banc of America Merrill Lynch.

謝謝，我們的下一個問題來自美國銀行美林證券的黃穎。

Hi, thanks for taking my questions. I have a quick one on also the pricing environment. If you look at VA sector and also the commercial factor, what kind of impact are you seeing from competition, particularly Merck (inaudible) from the pricing perspective. Then Quickly on R&D side, do you plan to develop a doublet maintenance regimen? For example, recently (inaudible), the combination showed actually good results in heavily pre-treated patients in the conference? Thank you.

您好，感謝您回答我的問題。我還有一個關於定價環境的簡短問題。如果你觀察VA產業以及商業因素，你會看到競爭，特別是默克（聽不清楚）在定價方面造成什麼樣的影響？那麼，在研發方面，你們是否計劃發展雙聯維持治療方案？例如，最近（聽不清楚），在會議上，這種聯合療法對接受過大量預先治療的患者顯示出了良好的效果？謝謝。

I'll take the first part in terms of pricing and competitive impact. Very little in terms of our commercial payer areas, because the contracts essentially were set up at the end of last year for the full year, so very little change in market share within the commercial payer segment. We still have a very strong position in VA with Harvoni and Sovaldi, particularly Harvoni. I think probably where we see increased competitive activity is in the Medicaid setting where, as I described it earlier, some of the smaller states are requesting contracts as they open up access so I think that's probably where we see the competition. Again, because of our very strong value proposition, we hope we can be successful in the majority of those but again, on occasions, we may find that they go to the competition.

我先從定價和競爭影響方面談起。就我們的商業支付方領域而言，變化非常小，因為合約基本上是在去年年底簽訂的，涵蓋全年，所以商業支付方領域的市場份額幾乎沒有變化。我們在 VA 領域仍然擁有非常強大的地位，尤其是 Harvoni 和 Sovaldi。我認為，競爭活動加劇的地方可能是醫療補助計劃領域，正如我之前描述的那樣，一些較小的州正在申請合同，因為它們正在開放醫療服務，所以我認為這裡可能是競爭的焦點所在。再次強調，由於我們擁有非常強大的價值主張，我們希望能夠在大多數情況下取得成功，但有時，我們可能會發現這些機會流向了競爭對手。

Yes, you asked the question about the (inaudible) we're of course aware of the data that were presented at [DSAL]. They looked fairly impressive, the number of genotypes with high SVR rates. However, what they are doing right now in Phase 3 is not looking at the eight-week treatment duration all genotypes in all patients. I would like to contrast this with our own triple combination SOF/VEL/VOX that John Milligan mentioned. We are looking essentially at two patient population. One patient population is experienced, that had previously failed other BAAs. That treatment duration's for 12 weeks and then were looking at all genotypes, cirrhotic and non-cirrhotic patients for eight-week treatment duration. We have one study in particular that only looks at eight weeks of treatment duration and the most difficult to treat genotype 3 cirrhotic patients because it's still a population where SVR rates are still in the low [90s] and we could push that up into the high [90s] that would be a step forward. I think our Phase 3 program, the data support our Phase 2 results then we will be a step ahead of all the competition.

是的，您問了關於（聽不清楚）的問題，我們當然知道在[DSAL]上提出的數據。具有高 SVR 率的基因型數量看起來相當驚人。然而，他們目前在第 3 期臨床試驗中並沒有研究所有患者所有基因型在 8 週治療期間的情況。我想將此與我們自己的 SOF/VEL/VOX 三重組合進行對比，正如 John Milligan 所提到的那樣。我們主要關注兩類患者群體。其中一組患者經驗豐富，之前接受過其他 BAA 手術但均告失敗。此治療持續時間為 12 週，然後我們觀察了所有基因型、肝硬化和非肝硬化患者的 8 週治療持續時間。我們有一項研究專門針對 8 週的治療持續時間和最難治療的基因型 3 肝硬化患者，因為該族群的 SVR 率仍然很低 [90%]，如果我們能將其提高到高 [90%]，那將是一大進步。我認為，如果我們的第三階段專案的數據能夠支持第二階段的結果，那麼我們將領先所有競爭對手一步。

Thank you. Our next question comes from Ian Somaiya of BMO Capital Markets.

謝謝。下一個問題來自 BMO 資本市場的 Ian Somaiya。

Thanks for taking my questions. Just wanted to follow-up on the triplet opportunity within hep C. Specifically, Norbert, just I don't know if you could describe the proportion of patients that have maybe failed in the first round of antivirals, whether it be doublet therapy or (inaudible) alone. I don't know if there's a prevalent pool that you can speak to. Then maybe I guess more question for Kevin, just how do we think about the triplet and its impact on margin price share?

謝謝您回答我的問題。我只是想跟進一下丙肝三合一療法的機會。具體來說，諾伯特，我不知道你是否可以描述一下在第一輪抗病毒治療中失敗的患者比例，無論是雙聯療法還是（聽不清楚）單藥治療。我不知道是否有比較普遍的群體可以諮詢。那麼，我或許應該問凱文一個問題，我們該如何看待這三重因素及其對利潤率和價格份額的影響？

Ian, we are doing essentially four studies with the triplet, what you call it the triplet, SOF/VEL/VOX. Two of them are in treatment experienced patients and what we would aspire to is to have this compound be the universal salvage regimen. Now Kevin, maybe you could comment on what the proportion of patients is that would qualify with this. Something I can tell you, in Japan there's a fairly large number of patients that have been treated with the Bristol Myers (inaudible). I think if I remember this correctly, they have SVR rates in Phase 3 of about 80% or thereabouts and they are about 9,000 patients now that we heard of are treatment experienced in that field. That those 9,000 would immediately be claimed in our own studies. As I said, I want to say it again, the other two studies is eight-week treatment duration for all patients, all genotypes, cirrhotic and non-cirrhotic. Kevin?

Ian，我們基本上正在進行四項關於三聯體的研究，也就是你所說的三聯體，SOF/VEL/VOX。其中兩名患者是接受過治療的資深患者，我們希望這種化合物能成為通用的挽救治療方案。凱文，或許你可以談談符合這項條件的患者比例是多少。我可以告訴你的是，在日本，有相當多的患者接受過百時美施貴寶（聽不清楚）的治療。如果我沒記錯的話，他們在第三階段的SVR率約為80%，目前我們聽說有大約9,000名患者在該領域接受過治療。我們自己的研究會立即發現這 9000 個問題。正如我所說，我想再說一遍，另外兩項研究對所有患者、所有基因型、肝硬化和非肝硬化患者均進行了為期八週的治療。凱文？

Yes, it's a good question, Ian. We're waiting to see some of the clinical -- obviously emerging clinical data. Right now, we've got a situation certainly in the US. Japan with it's resistant situation I think is perhaps quite unique in terms of the original use of the Bristol Myers regimen, but I think we've got patients being cured to an incredibly high level with Harvoni and now we've got the right treatment I think in that (inaudible) for twos and threes. I think in the US, perhaps in Europe, it will be far more modest an opportunity. Having said that, it depends where we are with those products, our products, where the competition is, obviously, what we decide to do in terms of the pricing strategy. I think most importantly from a company point of view, we think this is the right thing to do and probably the last step in the whole story around hepatitis C to help treatment experiences or failure patients. I think first and foremost we think this is the right thing to do for patients in need.

是的，伊恩，你問得好。我們正在等待一些臨床數據——顯然是正在湧現的臨床數據。目前，美國的情況確實如此。我認為，日本的抗藥性情況可能相當獨特，尤其是在最初使用布里斯托·邁爾斯療法方面。但我認為，使用哈維尼療法，患者的治癒率已經非常高了，現在我們找到了正確的治療方法，我認為可以治療二到三名患者。我認為在美國，或許在歐洲，這樣的機會會小得多。話雖如此，這取決於我們產品的市場狀況、競爭對手的情況，以及我們最終決定採取的定價策略。我認為從公司的角度來看，最重要的是，我們認為這是正確的事情，而且可能是圍繞丙型肝炎的整個故事的最後一步，以幫助治療經歷或治療失敗的患者。我認為，首先也是最重要的是，我們認為這樣做對有需要的患者來說是正確的。

Thank you. Our next question comes from Alethia Young of Credit Suisse.

謝謝。下一個問題來自瑞士信貸的阿萊西亞·楊。

Hey, guys. Thanks for taking my question. Let me be the thousandth person, Kevin, to say welcome back and it's great to have you here. Two questions in the same vein. Just one oncology, does this remain a focus for you guys, as far as building assets there and building out that business as much as it was in the past when you talk about it? Secondly, Norbert, with NASH, can you just talk about some of the data points coming up and what's going on with the FXR program as well? Thanks.

嘿，夥計們。謝謝您回答我的問題。凱文，讓我成為第一百個對你說「歡迎回來，很高興你在這裡」的人吧。兩個類似的問題。你們目前只專注於一種腫瘤領域，就資產累積和業務拓展而言，這是否仍然是你們的重點，就像你們過去談到的那樣？其次，Norbert，你代表 NASH，能否談談即將公佈的一些數據點，以及 FXR 專案的最新進展？謝謝。

Let me start off by first thing and John Milligan will afterwards comment on it too. We are in oncology. We have now (inaudible) end of the Phase 3 program, we should have data this year. If the data is (inaudible) track write application next year, we have the MMP9 in gastric cancer in Phase 3. We are looking at other solid tumors and we're now finally, after sorting out the dosing, starting the first study in combination of a PI3K inhibitor with BTK and CLL.

首先讓我說幾句，約翰·米利根之後也會對此發表評論。我們是腫瘤科醫師。我們現在（聽不清楚）第三階段計畫結束了，我們應該今年就能得到數據。如果數據（聽不清楚）明年提交申請，我們目前在胃癌領域有 MMP9 處於第 3 期臨床試驗階段。我們正在研究其他實體腫瘤，現在終於在確定劑量後，開始 PI3K 抑制劑與 BTK 聯合治療 CLL 的首項研究。

With regards to NASH, yes, we have now very interesting four modalities or four mechanisms that we are evaluating in NASH and at least three of them we know what they are supposed to do pharmacologically. We will have data this year on the ASK inhibitor that will includes liver fat analysis along with histology. The FXR agonist is currently in the Phase 1/Phase 2A study. By the way, we know about that compound already that it has minimal systemic absorption that they are systemic levels of SGS19. That was always our idea to have a compound that acts in the GI, that releases SGF19. The SGF19 has the efficacy and by that rational, we both get the side effects that other FXR agonists have. Finally, we have OGM ASK inhibitor -- ACC inhibitor, the Nimbus compound. We know those data were presented at DSAL that it reduces the (inaudible) of Genesis. What we're going to do based on these data is first ask if we could go into Phase 3 next year and to the other compound into Phase II with the FXR and the ACC inhibitor or even the ACO. John?

關於 NASH，是的，我們現在有四種非常有趣的模式或四種機制正在 NASH 中進行評估，其中至少有三種我們知道它們在藥理學上的作用。今年我們將獲得有關 ASK 抑制劑的數據，其中包括肝臟脂肪分析和組織學分析。FXR激動劑目前正處於1期/2A期研究階段。順便說一下，我們已經知道這種化合物的系統吸收極少，其係統水平為 SGS19。我們一直以來的想法就是研發一種作用於胃腸道並釋放 SGF19 的化合物。SGF19 具有療效，因此，我們兩個都會出現其他 FXR 激動劑所具有的副作用。最後，我們還有 OGM ASK 抑制劑——ACC 抑制劑，即 Nimbus 化合物。我們知道這些數據在DSAL上被展示出來，它減少了創世記中的（聽不清楚）內容。根據這些數據，我們首先要問的是，明年我們是否可以進入 3 期臨床試驗，然後讓另一種化合物與 FXR 和 ACC 抑制劑甚至 ACO 一起進入 2 期臨床試驗。約翰？

I just would follow up with Norbert's comment by saying yes, we are committed to oncology. We continue to be interested in assets, collaborations and partnerships where we could enhance our ability to continue to sell this product. Where we are seeing good progress, as Norbert mentioned, our BTK inhibitor, which is -- we did also with partner from Ono is now making its way into the clinic and we've overcome formulation challenges to allow us to go ahead so that will be very, very, I think, an interesting avenue for us to continue to explore.

我只想補充一下 Norbert 的評論，是的，我們致力於腫瘤學。我們仍然對能夠增強我們繼續銷售該產品能力的資產、合作和夥伴關係感興趣。正如諾伯特所提到的，我們取得了良好的進展，我們的 BTK 抑制劑——我們也是與小野藥品的合作夥伴共同研發的——現在正進入臨床試驗階段，我們已經克服了製劑方面的挑戰，使我們能夠繼續推進，所以我認為這將是一個非常非常有趣的途徑，值得我們繼續探索。

Thank you. Our final question comes from Terence Flynn of Goldman Sachs.

謝謝。最後一個問題來自高盛的特倫斯·弗林。

Hi. Thanks for taking the question. Just wondering, kind of a two-parter. The first is just any opportunity to broaden your prescriber base on hep C. Kevin, would love your thoughts on that. The second question relates to Genvoya. Can you just give us what percentage of the switches were from Atripla? Thanks.

你好。感謝您回答這個問題。只是好奇問，這有點像是兩個部分的問題。首先，任何能擴大丙肝處方醫師群體的機會都值得考慮。凱文，我很想聽聽你的看法。第二個問題與 Genvoya 有關。能否告知我們其中有多少百分比的交換器來自 Atripla？謝謝。

Hey, Terence. First of all, in terms of sort of like any [feature words of market], I did mention Australia earlier. That's an incredible story of treating and clearing patients and amazing commitment by the government there. We are seeing more patients treated in Brazil. It's a lower-priced market but we are seeing more. We are just beginning our launch in Mexico. So yes, these are smaller markets. Typically they are lower priced but those, if you like those smaller waves, are starting to work through. We are thinking carefully about China and how we launched there, probably in a very modest or a very focused, very efficient way, should I say, so we are expecting, I think, a very reasonable -- around China.

嘿，特倫斯。首先，就任何[市場特徵詞]而言，我之前確實提到了澳洲。這是一個關於治療和治癒病人的不可思議的故事，也展現了地方政府令人欽佩的奉獻精神。我們看到越來越多的患者在巴西接受治療。雖然市場價格較低，但我們看到的這類市場也越來越多。我們在墨西哥的業務才剛起步。是的，這些市場規模較小。通常來說，它們的價格較低，但如果你喜歡那種較小的波浪，它們也開始流行起來了。我們正在認真思考中國市場以及我們在中國的發展方式，或許是以非常低調、非常專注、非常有效率的方式，所以我認為，我們對中國市場的發展預期非常合理。

The second question, in terms of switch, about 18% of the switch patients is from Atripla, so I hope that gives you the number.

第二個問題，關於轉換治療，大約 18% 的轉換治療患者來自 Atripla，所以我希望這個數字能給你一些參考。

Thank you and that concludes our question-and-answer session for today. I'd like to turn the conference back over Mr. Lee for closing remarks.

謝謝大家，今天的問答環節到此結束。現在我把會議交還給李先生，請他作閉幕致詞。

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

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

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。