英賽德 (INCY) 2016 Q3 法說會逐字稿

Greetings and welcome to the Incyte Corp's third-quarter financial results earnings conference call.

歡迎來到 Incyte Corp 第三季度財務業績收益電話會議。

( Operator Instructions )

（操作說明）

It is now my pleasure to introduce your host Mike Booth Vice President of Investor Relations for Incyte. Thank you may begin.

現在我很高興向您介紹主持人 Mike Booth，Incyte 投資者關係副總裁。謝謝你可以開始了。

Thank you Diego. Good morning and welcome to Incyte's third-quarter 2016 earnings conference call and webcast.

謝謝迭戈。早上好，歡迎收看 Incyte 2016 年第三季度收益電話會議和網絡廣播。

The slides used today are available for download on the investors section of www.Incyte.com. Speaking on today's call will be Herve Hoppenot, our CEO, who will begin with some high level comments in our objectives and priorities here at Incyte.

今天使用的幻燈片可在 www.Incyte.com 的投資者部分下載。在今天的電話會議上發言的是我們的首席執行官 Herve Hoppenot，他將首先對我們在 Incyte 的目標和優先事項發表一些高層評論。

Herve will then pass to Barry Flannelly who leads our US organization, and who will provide an update of Jakafi sales and prescription trends during Q3, as well as touch on Jakafi's recent inclusion in the NCCN Guidelines.

然後，Herve 將交給領導我們美國組織的 Barry Flannelly，他將在第三季度提供 Jakafi 銷售和處方趨勢的更新，以及 Jakafi 最近被納入 NCCN 指南。

Steven Stein, Incyte's Chief Medical Officer will briefly review the updated ECHO-202 data of epacadostat plus pembrolizumab as presented at ESMO, and provide some background on our decision to initiate a Phase 2 trial of our FGFR inhibitor 54828 for the treatment of patients with Cholangiocarcinoma.

Incyte 首席醫療官 Steven Stein 將簡要回顧在 ESMO 上展示的 epacadostat 加 pembrolizumab 的更新 ECHO-202 數據，並提供一些背景，說明我們決定啟動我們的 FGFR 抑製劑 54828 治療膽管癌患者的 2 期試驗.

Dave Gryska our CFO will summarize our third-quarter financial results before opening the call for Q&A, for which we will be joined by Reid Huber our Chief Scientific Officer.

我們的首席財務官 Dave Gryska 將在開始問答之前總結我們第三季度的財務業績，我們的首席科學官 Reid Huber 將加入我們的行列。

We would like to remind you that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for 2016 guidance, the commercialization of our products, and our development plans for the compounds in our pipeline. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our 10-Q for the quarter ended June 30, 2016 and from time to time in our other SEC documents.

我們想提醒您，今天電話會議中所做的一些陳述是前瞻性陳述，包括關於我們對 2016 年指南的預期、我們產品的商業化以及我們管道中化合物的開發計劃的陳述。這些前瞻性陳述受到許多風險和不確定性的影響，這些風險和不確定性可能導致我們的實際結果存在重大差異，包括我們截至 2016 年 6 月 30 日的季度 10-Q 和我們其他 SEC 文件中不時描述的那些.

I would now like to pass the call to Herve for some introductory remarks.

我現在想將電話轉給 Herve，請他做一些介紹性發言。

Thank you Mike and good morning everyone.

謝謝邁克，大家早上好。

We have made excellent progress during the third quarter, both on the top line, as well as within our portfolio. Before we dig into the details I would like to begin our discussion today by taking a step back and talking briefly about what we are trying to build here at Incyte.

我們在第三季度取得了出色的進展，無論是在收入方面，還是在我們的投資組合中。在我們深入探討細節之前，我想先退後一步，簡要談談我們在因塞特 (Incyte) 試圖打造的東西，以此開始我們今天的討論。

Cancer is one of the biggest challenges facing our society today. It certainly has a significant impact on the well-being of millions of cancer patients, as well as their loved ones, but it also has a substantial economic impact both through lost productivity and the effect on the healthcare system.

癌症是當今社會面臨的最大挑戰之一。它當然對數百萬癌症患者及其親人的福祉產生重大影響，但它也會通過生產力損失和對醫療保健系統的影響而產生重大的經濟影響。

The need for more effective treatments is clear and advances are being made.

對更有效治療的需求是顯而易見的，並且正在取得進展。

As shown in the chart on the left side of slide 6, since 2010 the number of new Hematology and Oncology approvals by the FDA has been on an upward trend, and the chart on the right illustrates how patient outcomes in melanoma, depicted as improvement in progression-free survival, have improved with different therapeutic regimens from chemotherapy through BRAF and MEK inhibitors, to Immuno-Oncology doublets.

如幻燈片 6 左側的圖表所示，自 2010 年以來，FDA 批准的新血液學和腫瘤學的數量呈上升趨勢，右側的圖表說明了黑色素瘤患者的治療結果，描述為無進展生存期，通過 BRAF 和 MEK 抑製劑化療到免疫腫瘤雙聯療法等不同治療方案得到改善。

Many of us felt a sense of excitement at the ESMO conference last month, given the wealth of data presented and a number of innovative therapies being discussed. It also provided us with further evidence that the scientific community, where Incyte is an active participant, is in the process of transforming the treatment of cancer.

在上個月的 ESMO 會議上，我們中的許多人都感到興奮，因為提供了豐富的數據並且正在討論許多創新療法。它還為我們提供了進一步的證據，表明因塞特公司積極參與的科學界正在改變癌症的治療方法。

Incyte is a company built on innovation and we strive to bring first or best in class therapies to patients in need. Our portfolio now contains 15 different candidates across 11 different targets and we employ around 1,000 people in the US and across Europe. With total revenue in Q3 that grew 44% over the same period last year we are in a position to reinvest our resources in multiple therapeutic opportunities.

Incyte 是一家以創新為基礎的公司，我們努力為有需要的患者提供一流或一流的療法。我們的投資組合現在包含 11 個不同目標的 15 名不同候選人，我們在美國和歐洲僱傭了大約 1,000 名員工。第三季度的總收入比去年同期增長了 44%，我們能夠將我們的資源重新投資於多種治療機會。

Sales of Jakafi continue to show robust growth as we approach the five-year anniversary of its initial US approval, and combining Jakafi sales in the US, Iclusig sales in Europe, and Jakafi royalties from Novartis provides us with dynamic revenue growth. We also have an additional potential source of revenue from Baricitinib being developed by our partner Eli Lilly, which is currently under global regulatory review for the treatment of patients with rheumatoid arthritis.

隨著 Jakafi 在美國首次獲批五週年的臨近，Jakafi 的銷售額繼續呈現強勁增長，結合 Jakafi 在美國的銷售、Iclusig 在歐洲的銷售以及來自諾華的 Jakafi 特許權使用費，為我們帶來了強勁的收入增長。我們還有一個額外的潛在收入來源，來自我們的合作夥伴禮來公司正在開發的 Baricitinib，該藥物目前正在接受全球監管審查，用於治療類風濕性關節炎患者。

With our financial resources and dynamic top line growth we can reinvest in a virtuous cycle of product development to bring additional innovative therapies to patients. We have a diverse portfolio of products and are building medical and commercial footprints in major markets around the globe. Having global development expertise in-house is already enabling us to develop our products more effectively and we will also seek to use in-house commercial teams to successfully launch our products upon approval.

憑藉我們的財務資源和動態的收入增長，我們可以對產品開發的良性循環進行再投資，為患者帶來更多的創新療法。我們擁有多樣化的產品組合，並正在全球主要市場建立醫療和商業足跡。內部擁有全球開發專業知識已經使我們能夠更有效地開發我們的產品，我們還將尋求利用內部商業團隊在獲得批准後成功推出我們的產品。

I will now pass the call to Barry for an update on Jakafi.

我現在將電話轉給 Barry，了解 Jakafi 的最新情況。

Thank you Herve and good morning everyone.

謝謝 Herve，大家早上好。

Sales of Jakafi continue to perform well. In the third quarter net product revenue from Jakafi was $224 million, a 39% increase over the third quarter of 2015 and 8% increase over the previous quarter. In view of this strong growth we are increasing our 2016 Jakafi net product revenue guidance to a range of $850 million to $855 million from the previous range of $825 million to $835 million.

Jakafi 的銷售繼續表現良好。第三季度來自 Jakafi 的淨產品收入為 2.24 億美元，比 2015 年第三季度增長 39%，比上一季度增長 8%。鑑於這種強勁增長，我們將 2016 年 Jakafi 淨產品收入指引從之前的 8.25 億美元至 8.35 億美元上調至 8.5 億美元至 8.55 億美元。

We are pleased that nearly five years after its first approval we now have approximately 9,000 patients currently being treated with Jakafi and that number continues to grow. Growth comes from our position education efforts, especially detailing on the long-term benefits that Jakafi treatment provides.

我們很高興，在 Jakafi 首次獲得批准近五年後，我們現在有大約 9,000 名患者正在接受 Jakafi 治療，而且這個數字還在繼續增長。增長來自我們的職位教育工作，特別是詳細介紹 Jakafi 治療提供的長期利益。

The chart on the right side of slide 10 illustrates the strong year-on-year demand growth that we are experiencing with both of Jakafi's approved indications. In September we announced that Jakafi has been included as a recommended treatment for appropriate patients with myelofibrosis in the latest NCCN guidelines. Inclusion in the guidelines will help inform healthcare providers' treatment decisions for patients with myelofibrosis and we believe that inclusion in the NCCN guidelines also underscores the important and long-term clinical benefits seen in patients treated with Jakafi.

幻燈片 10 右側的圖表說明了我們在 Jakafi 的兩個批准適應症中經歷的強勁的同比需求增長。 9 月，我們宣布 Jakafi 已作為適用於骨髓纖維化患者的推薦治療藥物納入最新的 NCCN 指南。包含在指南中將有助於告知醫療保健提供者對骨髓纖維化患者的治療決策，我們相信包含在 NCCN 指南中也強調了在接受 Jakafi 治療的患者中看到的重要和長期臨床益處。

We are also looking forward to the ASH conference in December, where a pooled analysis of the five-year overall survival data from both COMFORT-1 and COMFORT-2 studies of Jakafi in patients with myelofibrosis will be presented.

我們也期待 12 月的 ASH 會議，屆時將對 Jakafi 治療骨髓纖維化患者的 COMFORT-1 和 COMFORT-2 研究的五年總體生存數據進行匯總分析。

I would now like to pass the call along to Steven for a clinical update.

我現在想將電話轉給 Steven 進行臨床更新。

Thanks Barry.

謝謝巴里。

We've made good progress within our development portfolio since our last quarterly conference call, and today I would like to concentrate on the recent epacadostat data update at the recent European Society for Medical Oncology meeting, and on our 54828 our FGFR inhibitor, for which we've recently opened a second Phase 2 trial.

自上次季度電話會議以來，我們在開發組合方面取得了良好進展，今天我想集中討論最近歐洲腫瘤內科學會會議上的最新 epacadostat 數據更新，以及我們的 54828 FGFR 抑製劑，為此我們最近開始了第二階段的試驗。

Last month updated Phase 1 data from the ECHO-202 trial of epacadostat plus pembrolizumab in patients with advanced melanoma and select solid tumors were presented at the ESMO Annual Congress in Copenhagen.

上個月在哥本哈根舉行的 ESMO 年會上公佈了 epacadostat 聯合派姆單抗治療晚期黑色素瘤和特定實體瘤患者的 ECHO-202 試驗的 1 期更新數據。

I would like to start my brief overview of the data with patient safety data. Now with 56 weeks median follow-up for responders, and that's much greater drug exposure than our last presentation at SITC in November 2015, the combination of epacadostat plus pembrolizumab continues to be well-tolerated. There were no treatment-related deaths, and the maximum tolerated dose of epacadostat has not been reached. 19% of patients in the trial experience grade three or four treatment-related adverse events and five patients, or 8%, experienced treatment-related adverse events that led to discontinuation.

我想從患者安全數據開始簡要概述數據。現在，響應者的中位隨訪時間為 56 週，這比我們 2015 年 11 月在 SITC 上一次展示的藥物暴露量大得多，epacadostat 加 pembrolizumab 的組合繼續具有良好的耐受性。沒有發生與治療相關的死亡，也沒有達到 epacadostat 的最大耐受劑量。試驗中 19% 的患者經歷了三級或四級治療相關的不良事件，五名患者或 8% 的患者經歷了導致停藥的治療相關不良事件。

The next slide shows the waterfall and spider plots of the patients with Treatment-naive melanoma. The overall response rate in this population was 58% and the disease control rate was 74% by RECIST. For responders, the median follow-up was greater than 56 weeks, with a range of 46 to 90 weeks, importantly at this presentation all responders remained in response at the time of the data cut.

下一張幻燈片顯示了未經治療的黑色素瘤患者的瀑布圖和蛛網圖。根據 RECIST，該人群的總體反應率為 58%，疾病控制率為 74%。對於響應者，中位隨訪時間超過 56 週，範圍為 46 至 90 週，重要的是在本次演示中，所有響應者在數據削減時都保持響應。

Slide 15 shows progression-free survival. The median progression-free survival has not been reached. The six-month progression-free survival rate is 74%, and the 12-month progression-free survival rate is 57%.

幻燈片 15 顯示無進展生存期。尚未達到中位無進展生存期。 6 個月無進展生存率為 74%，12 個月無進展生存率為 57%。

With all the necessary caveats of cross trial comparisons we believe our data compared favorably to establish benchmarks. Recall that progression-free survival is one of the two jeweled primary endpoints in the ongoing ECHO-301 Phase 3 trial of epacadostat plus pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma.

考慮到交叉試驗比較的所有必要注意事項，我們相信我們的數據比較有利，可以建立基準。回想一下，無進展生存期是正在進行的 ECHO-301 3 期試驗中的兩個主要終點之一，該試驗使用 epacadostat 聯合 pembrolizumab 一線治療晚期或轉移性黑色素瘤患者。

Let's move onto our FGFR development program on slide 16. We announced in our second quarter update that we were initiating a Phase 2 trial of 54828 in patients with bladder cancer. This study is now open for recruitment.

讓我們轉到幻燈片 16 上的 FGFR 開發計劃。我們在第二季度更新中宣布，我們正在啟動 54828 名膀胱癌患者的 2 期試驗。這項研究現已開放招募。

In addition we have also been to Phase 2 study of 54828 in patients with Cholangiocarcinoma, a type of biliary track cancer. While treatment of this type of cancer can be curative, if found early enough for surgical resection, most cases are diagnosed in the later stages, where resection is not a possibility.

此外，我們還對 54828 名膽管癌患者進行了 2 期研究，膽管癌是一種膽管癌。雖然這種類型的癌症的治療可以治愈，但如果發現得足夠早以進行手術切除，大多數病例被診斷為晚期，切除是不可能的。

Cholangiocarcinoma is rare, with incidence in the US and Western Europe of around 1.6 cases per 100,000 population. The rates are significantly higher in Asia. In Japan, for example, the incidence is 3.2 cases per 100,000 population, while incidence and other Southeast Asia countries is higher still. Between 6% and 13% of all cholangiocarcinoma patients have FGFR2 translocations, and an additional 5% have other FGF or FGFR alterations. We are not aware of differential geneotypic rates by geography.

膽管癌很少見，在美國和西歐的發病率約為每 100,000 人 1.6 例。亞洲的比率要高得多。以日本為例，發病率為每10萬人3.2例，而其他東南亞國家發病率更高。所有膽管癌患者中有 6% 至 13% 有 FGFR2 易位，另有 5% 有其他 FGF 或 FGFR 改變。我們不知道地理差異基因型率。

The primary endpoint of the Phase 2 cholangiocarcinoma study will be overall response rate in patients with FGFR2 translocations. Secondary endpoints will include overall response rate in patients with other FGFR alterations.

2 期膽管癌研究的主要終點將是 FGFR2 易位患者的總體反應率。次要終點將包括具有其他 FGFR 改變的患者的總體反應率。

Slide 17 summarizes the whole portfolio, which now includes 15 development candidates against 11 different molecular targets. The portfolio graphic now includes 57643 which is our second BRD inhibitor and which is currently in a dose escalation study. As we have done with many of our programs, we have elected to progress two distinct BRD inhibitors into development. These compounds allow us an opportunity to evaluate different pharmacokinetic and pharmacodynamic profiles, thereby increasing our optionality around decision-making and what is becoming an exciting therapeutic class.

幻燈片 17 總結了整個產品組合，現在包括針對 11 個不同分子靶點的 15 個開發候選藥物。產品組合圖現在包括 57643，它是我們的第二個 BRD 抑製劑，目前正在進行劑量遞增研究。正如我們對許多項目所做的那樣，我們選擇將兩種不同的 BRD 抑製劑推進開發。這些化合物使我們有機會評估不同的藥代動力學和藥效學特徵，從而增加我們在決策制定方面的選擇性以及正在成為令人興奮的治療類別。

I will finish on our news flow slide. There are multiple potential value drivers for Incyte over the next 12 months. We are finalizing our plans to initiate the pivotal program for ruxolitinib in graft versus host disease, and we also expect to provide you with proof of concept data from our JAK-1 program in graft versus host disease at the American Society of Hematology Conference in early December.

我將完成我們的新聞流幻燈片。在接下來的 12 個月中，Incyte 有多個潛在的價值驅動因素。我們正在最終確定啟動 ruxolitinib 在移植物抗宿主病中的關鍵項目的計劃，我們還希望在早期的美國血液學會會議上為您提供我們在移植物抗宿主病中的 JAK-1 項目的概念驗證數據十二月。

We remain on track to initiate the 39110 plus osimertinib study in lung cancer by the end of the year, and we also look forward to providing you with initial clinical data from the FGFR and BRD programs next year as the data become available.

我們仍有望在年底前啟動 39110 加奧希替尼治療肺癌的研究，我們也期待明年在數據可用時為您提供 FGFR 和 BRD 計劃的初步臨床數據。

In immuno-oncology and beginning in the first half of next year we look forward to sharing data from some of the Phase 2 cohorts of the ECHO trial of epacadostat in combination with PD-1 and PDL-1 inhibitors. We also remain on track to initiate a proof of concept study for our anti-OX40 agonist antibody 1949 in the fourth quarter of 2016. Data from Incyte's Phase 2 trial of topical ruxolitinib for the treatment of patients with alopecia areata have been accepted for presentation at the 2016 Alopecia Areata Research Summit, which is taking place in New York City on November 14th and 15th. Last but not least, we are looking forward to the first regulatory decisions on baricitinib.

在免疫腫瘤學方面，從明年上半年開始，我們期待與 epacadostat 聯合 PD-1 和 PDL-1 抑製劑的 ECHO 試驗的一些 2 期隊列共享數據。我們還將繼續按計劃在 2016 年第四季度啟動我們的抗 OX40 激動劑抗體 1949 的概念驗證研究。來自因塞特 (Incyte) 的局部 ruxolitinib 治療斑禿患者的 2 期試驗數據已被接受並在2016 年斑禿研究峰會將於 11 月 14 日至 15 日在紐約市舉行。最後但同樣重要的是，我們期待著對 baricitinib 的第一個監管決定。

With that I will pass the call to Dave for the financials.

有了這個，我會把電話轉給戴夫，讓他了解財務狀況。

Thanks Steven and good morning everyone.

謝謝史蒂文，大家早上好。

In the third quarter we recorded $269 million of total revenue. This was comprised of $224 million in Jakafi net product revenue, $13 million in Iclusig net product revenue, $29 million and Jakafi royalties from Novartis, and $3 million in contract revenue. Jakafi's net product revenue of $224 million represents 39% growth over the same period last year. Based on Jakafi's performance year-to-date, we are increasing our full-year Jakafi net product revenue guidance to a range of $850 million-$855 million.

第三季度，我們的總收入為 2.69 億美元。這包括 2.24 億美元的 Jakafi 淨產品收入、1300 萬美元的 Iclusig 淨產品收入、2900 萬美元和來自諾華的 Jakafi 特許權使用費以及 300 萬美元的合同收入。 Jakafi 的淨產品收入為 2.24 億美元，比去年同期增長 39%。根據 Jakafi 年初至今的業績，我們將 Jakafi 的全年淨產品收入預期提高到 8.5 億美元至 8.55 億美元。

Our gross net adjustment for the third quarter was approximately 12%. We expect that gross and adjustment for the full year to be approximately 12%.

我們對第三季度的淨調整總額約為 12%。我們預計全年毛利率和調整值約為 12%。

Our cost of product revenue for the quarter was $20 million. This includes the cost of goods sold for Jakafi and Iclusig, the payment of royalties from Novartis on US Jakafi net sales, and $5 million for the amortization of acquired product rights related to the Iclusig product acquisition.

我們本季度的產品收入成本為 2000 萬美元。這包括為 Jakafi 和 Iclusig 銷售的商品成本、諾華公司支付的美國 Jakafi 淨銷售額的特許權使用費，以及與 Iclusig 產品收購相關的已獲產品權利的攤銷費用 500 萬美元。

Our R&D expense for the quarter was $143 million, including $16 million in non-cash stock compensation. Looking at projected R&D expense for the full year we are updating our current guidance to a range of $570 million-$580 million.

我們本季度的研發費用為 1.43 億美元，其中包括 1600 萬美元的非現金股票補償。查看全年的預計研發費用，我們將當前的指導更新為 5.7 億美元至 5.8 億美元的範圍。

The reduction in projected R&D expense for the previous guidance for 2016 is in large part due to slower than forecasted headcount growth and phasing of certain expenses from various programs in our development pipeline into next year. We will provide a range of next year's R&D expense in our fourth-quarter call in February, and given the breadth of opportunities in our current portfolio we expect a substantial increase in R&D expense in 2017.

2016 年先前指導的預計研發費用減少在很大程度上是由於員工人數增長慢於預期，以及我們開發管道中各種項目的某些費用分階段到明年。我們將在 2 月的第四季度電話會議中提供一系列明年的研發費用，鑑於我們當前產品組合中的機會範圍，我們預計 2017 年的研發費用將大幅增加。

Our SG&A expense for the quarter was $76 million, including $10 million in non-cash stock compensation. We are on track to end the full year with our existing guidance in the range of $285 million to $310 million. We recorded $8 million in expenses related to the change in fair market value of the contingent consideration for the Iclusig royalty liability and we expect the full-year amount to be approximately $17 million.

我們本季度的 SG&A 費用為 7600 萬美元，其中包括 1000 萬美元的非現金股票補償。我們有望以 2.85 億美元至 3.1 億美元的現有指導結束全年。我們記錄了 800 萬美元與 Iclusig 特許權使用費負債的或有對價的公平市場價值變化相關的費用，我們預計全年金額約為 1700 萬美元。

Turning now to net income and earnings-per-share for the third quarter, we reported $37 million in net income or $0.20 per share basic and $0.19 per share diluted. We now expect 2016 net income to be in a range of $100 million to $110 million. This range also reflects the quarter-to-date decline in the market value of a long-term investment.

現在轉向第三季度的淨收入和每股收益，我們報告的淨收入為 3700 萬美元，即基本每股 0.20 美元和稀釋後每股 0.19 美元。我們現在預計 2016 年的淨收入將在 1 億美元至 1.1 億美元之間。這一範圍也反映了長期投資市場價值本季度迄今的下降。

Looking at our balance sheet, we ended the third quarter with $717 million in cash and cash equivalents. We expect positive cash flow for the remainder of the year and expect to end the year with over $750 million in cash and cash equivalents.

查看我們的資產負債表，我們在第三季度結束時擁有 7.17 億美元的現金和現金等價物。我們預計今年剩餘時間的現金流為正，預計年底現金和現金等價物將超過 7.5 億美元。

As noted in our press release, Novartis achieved pricing approval for Jakafi in polycythmia vera in the third major European country in October, which triggered a $40 million milestone. We will record this $40 million milestone in the fourth quarter.

正如我們在新聞稿中指出的那樣，諾華（Novartis）於 10 月在第三大歐洲國家獲得了 Jakafi 治療真性紅細胞增多症的定價批准，這觸發了 4000 萬美元的里程碑。我們將在第四季度記錄這個 4000 萬美元的里程碑。

To summarize, we are very pleased with Incyte's performance in the third quarter. Jakafi delivered strong revenue growth. We have fully integrated our new business unit in Europe. We grew our cash position and continue to make significant investments in our clinical development programs.

總而言之，我們對 Incyte 在第三季度的表現感到非常滿意。 Jakafi 實現了強勁的收入增長。我們已經完全整合了我們在歐洲的新業務部門。我們增加了現金頭寸，並繼續對我們的臨床開發計劃進行大量投資。

Incyte is well-positioned from a cash and operating income perspective to execute on our strategies for growth, which we are confident will deliver significant long-term shareholder value. Operator that concludes our prepared remarks please give your instructions and open up the call for Q&A.

從現金和營業收入的角度來看，Incyte 處於有利地位，可以執行我們的增長戰略，我們相信這將帶來可觀的長期股東價值。結束我們準備好的評論的接線員請給出您的指示並打開問答電話。

Thank you.

謝謝。

Thank you.

謝謝。

( Operator instructions )

（操作員說明）

Salveen Richter, Goldman Sachs.

Salveen Richter，高盛。

Thanks for taking my question.

感謝您提出我的問題。

Just given the milestones from Novartis in the lead for the next three quarters and base business growth, it would appear that you will be EPS GAAP profitable going forward. Is that a fair assumption? Then a second question on the bromodomain program, can you give us a little more clarity in the difference between 54329 and the new molecule? Will you be moving into different indications and when should we expect initial data from both?

鑑於諾華在未來三個季度的領先地位和基礎業務增長的里程碑，看來你將在 EPS GAAP 中實現盈利。這是一個公平的假設嗎？然後是關於 bromodomain 程序的第二個問題，您能否更清楚地說明 54329 和新分子之間的區別？你會轉向不同的適應症嗎？我們什麼時候應該從這兩個方面獲得初始數據？

Thanks.

謝謝。

Salveen I will answer the first question. Yes we will be EPS positive for this year, as I mentioned, the range is between $100 million to $110 million. Obviously we have not given guidance out for next year and we'll be doing that in our February conference call.

Salveen 我會回答第一個問題。是的，正如我提到的，我們今年的每股收益將是積極的，範圍在 1 億美元到 1.1 億美元之間。顯然我們還沒有給出明年的指導，我們將在 2 月份的電話會議上這樣做。

Salveen this is Reid, thanks for the question on BRD. As we've done for many of our programs we often will progress more than one molecule in the clinic when it's appropriate to evaluate different pharmacokinetic and pharmacodynamic profiles in Phase 1. Bromodomain inhibitions is an excited therapeutic opportunity. I think were still at the early stages of that, and we think we're best positioned by evaluating both 54329 and the follow-on compound 57643.

Salveen，我是 Reid，感謝 BRD 的提問。正如我們為許多項目所做的那樣，當適合在 1 期評估不同的藥代動力學和藥效學特徵時，我們通常會在臨床上取得不止一種分子的進展。溴結構域抑制是一個令人興奮的治療機會。我認為我們仍處於早期階段，我們認為通過評估 54329 和後續化合物 57643，我們處於最佳位置。

It's really about evaluating different PK profiles and potentially different pharmadynamic profiles and seeing how that may affect efficacy and safety. We look forward to seeing those data merge over the next few quarters and certainly will share them with you as we are ready.

這實際上是關於評估不同的藥代動力學特徵和可能不同的藥效學特徵，並了解它們如何影響療效和安全性。我們期待在接下來的幾個季度中看到這些數據合併，當然會在我們準備好時與您分享。

Thank you.

謝謝。

Corey Kasimov, JPMorgan.

摩根大通的科里卡西莫夫。

Great thank you good morning guys. I appreciate you taking the questions and nice quarter.

非常感謝大家早上好。感謝您提出問題和愉快的季度。

So two of them for you. First of all can you talk about the potential significance of the recent NCCN treatment guidelines for Jakafi and how that might drive use above and beyond how it is positioned in the market today? Do you know if there's a plan to publish guidelines for PV as well?

所以他們兩個給你。首先，您能否談談最近 NCCN 治療指南對 Jakafi 的潛在意義，以及它如何推動使用超出其當今市場定位的範圍？您知道是否也有發布 PV 指南的計劃？

Then my follow-up question was just clarification. I was wondering if you could just talk about what you mean in your press release where you say enrollment was suspended in the Phase 1/2 trial for your PD-1. I guess that term suspended can mean a number of different things.

然後我的後續問題只是澄清。我想知道您是否可以談談您在新聞稿中所說的 PD-1 的 1/2 期試驗暫停註冊的意思。我想暫停這個詞可能意味著很多不同的事情。

Thanks.

謝謝。

So Cory, this is Barry, I will answer the first couple of questions about the NCCN guidelines. The easier one is they've indicated that they'll release sometime in 2017, maybe over the next first six months of 2017, guidelines for polycythemia vera and essential thrombocythemia.

Cory，我是 Barry，我將回答有關 NCCN 指南的前幾個問題。更簡單的是他們表示他們將在 2017 年的某個時候發布，可能會在 2017 年的前六個月發布真性紅細胞增多症和原發性血小板增多症指南。

The first question about whether -- we're just very positive about the NCCN, their approach in myelofibrosis and it reinforces our clinical data. We already have approval in patients who have intermediate one to high risk patients and there's really very few patients in the low risk category, maybe 10% of the patients. Their recommendation was symptomatic patients that have low risk so we think that represents a small patient population.

第一個問題是——我們是否對 NCCN 非常積極，他們在骨髓纖維化方面的方法是否加強了我們的臨床數據。我們已經在中等風險到高風險患者中獲得批准，低風險類別的患者真的很少，可能佔患者的 10%。他們的建議是有症狀的低風險患者，因此我們認為這代表了一小部分患者。

Cory hi, it's Steven Stein. Thanks for your question related to 1210.

Cory 嗨，我是 Steven Stein。感謝您提出有關 1210 的問題。

The www.clinicaltrials.gov listing actually says active not recruiting. As of October 21 of this year we notified investigators that enrollment of new subjects to the Phase 1 trial of 1210 had been placed on hold in order to perform a thorough assessment of the compounds profile. I'm not going to be able today to give you any more details on this as we are in the midst of that review of that compounds profile.

www.clinicaltrials.gov 列表實際上說的是活躍而不是招募。截至今年 10 月 21 日，我們通知研究人員，為了對化合物概況進行全面評估，1210 的 1 期試驗的新受試者招募已暫停。我今天無法向您提供更多詳細信息，因為我們正在審查該化合物概況。

Okay. Thank you.

好的。謝謝。

Michael Schmidt, Leerink Partners.

Leerink Partners 的邁克爾·施密特 (Michael Schmidt)。

Good morning and thanks for taking my questions.

早上好，謝謝你回答我的問題。

I had two on Jakafi: a commercial question in terms of sequential growth could you breakout inventory versus price versus volume growth? Then the second question is as we are waiting results from Gilead's momelotinib trials in MF later this quarter, can you give us a sense of how you think about your competitive position in MF, in particular in patients that have anemia at base-line or are transfusion dependent and how Jakafi used in those patients for example.

我有兩個關於 Jakafi 的問題：一個關於連續增長的商業問題，你能打破庫存與價格與數量增長的關係嗎？那麼第二個問題是，由於我們正在等待本季度晚些時候 Gilead 在 MF 中的 momelotinib 試驗的結果，您能否告訴我們您如何看待您在 MF 中的競爭地位，特別是在基線貧血或貧血的患者中？例如，輸血依賴性以及 Jakafi 如何用於這些患者。

Thank you.

謝謝。

For your first question -- there was no pricing in Q2 versus Q3. It was the same wholesale acquisition price and in fact there was very little inventory movement one way or the other so the 8% growth quarter-over-quarter was most entirely demand.

對於你的第一個問題——第二季度和第三季度沒有定價。這是相同的批發收購價格，事實上，無論哪種方式，庫存變動都非常小，因此 8% 的環比增長大部分完全是需求造成的。

Your second question related to momelotinib: we think the clinical profile of Jakafi stands up very well to any compound in the treatment of myelofibrosis. Remember they are only going after an indication in myelofibrosis, they have no polycythemia vera indication.

你的第二個問題與 momelotinib 相關：我們認為 Jakafi 的臨床特徵優於任何治療骨髓纖維化的化合物。請記住，他們只是在尋找骨髓纖維化的指徵，他們沒有真性紅細胞增多症的指徵。

In terms of anemia we will see when their data reports out but we know from further analysis of our COMFORT trials that patients that came in with anemia or experienced anemia while on Jakafi in fact still benefited from the drug and still had an improved survival advantage versus patients who did not receive Jakafi. We think it's a compelling clinical profile for the drug and we'll see what happens when they report out their data sometime in the future.

在貧血方面，我們將看到他們的數據何時報告，但我們從對我們的 COMFORT 試驗的進一步分析中得知，患有貧血或在服用 Jakafi 期間經歷過貧血的患者實際上仍然受益於該藥物，並且與相比相比，仍然具有更高的生存優勢未接受 Jakafi 的患者。我們認為這是該藥物令人信服的臨床資料，我們將在他們將來某個時候報告數據時看看會發生什麼。

Great. Thank you.

偉大的。謝謝。

Josh Schimmer, Piper Jaffray.

喬什·希默，派珀·杰弗瑞。

Thanks for taking my question. First, you indicated a substantial increase in R&D next year, I'm wondered if there's any way to quantify that ahead of your guidance? As well as you think about advancing epacadostat into additional Phase 3 solid tumors settings, when do you think you will have adequate data to inform those decisions? And what kind of bandwidth do expect to have in the R&D budget to accommodate multiple simultaneous Phase 3 programs.

感謝您提出我的問題。首先，您表示明年研發將大幅增加，我想知道是否有任何方法可以在您的指導之前對其進行量化？除了您考慮將 epacadostat 推進到其他 3 期實體瘤設置中，您認為什麼時候會有足夠的數據來為這些決定提供信息？以及在研發預算中期望有什麼樣的帶寬來容納多個同時進行的第 3 階段項目。

Thanks.

謝謝。

Okay so I will answer the first part of your question. In terms of the R&D for next year we are not going to quantify what substantial means. Rest assured that it will go up from where it is today because of some phasing in some shifting from this year into next year into the R&D. And Herve is going to answer the second part of your question.

好的，我將回答您問題的第一部分。就明年的研發而言，我們不會量化實質性的含義。請放心，它會從今天的位置上升，因為從今年到明年的一些階段性轉移到研發中。 Herve 將回答您問題的第二部分。

The reason why we spoke about increase for next year is because, as you saw in Q3, there were a number of expenses that we were planning to see happening during the next few months that have been moved into next year. We wanted to make sure everybody understood that, in fact the intensity of the development program is not slowing down at all. We have multiple projects that are starting.

我們談到明年增加的原因是因為，正如您在第三季度看到的那樣，我們計劃在接下來的幾個月內發生一些費用，這些費用已轉移到明年。我們想確保每個人都明白，事實上開發計劃的強度根本沒有放緩。我們有多個項目正在啟動。

And in the case of epacadostat, as I have to said, we would be open to multiple Phase 3 studies when the data is available and we have the resources to do that and we would not slow down in any way the program for epacadostat based on budget impact. We are able now with the strength of our top line growth coming from multiple sources to sustain and afford for multiple Phase 3 over a period of years. That's really the picture we have.

就 epacadostat 而言，正如我不得不說的那樣，當數據可用時，我們將對多項第 3 階段研究持開放態度，並且我們有資源去做，我們不會以任何方式放慢基於 epacadostat 的程序預算影響。我們現在能夠利用來自多個來源的收入增長的力量來維持和負擔數年內的多個第 3 階段。這確實是我們的照片。

And the comment about next year was just to make sure that people understood that the way the Q3 R&D budget has been evolving is not something that you can trend for the next quarters. It will probably go through a rebound over the next few quarters.

關於明年的評論只是為了確保人們理解第三季度研發預算的演變方式不是你可以在接下來的幾個季度中趨勢的。它可能會在接下來的幾個季度經歷反彈。

Does that mean that you are not looking at this point to manage the business for bottom-line growth but more for R&D investment and capital allocation, or how do you think of that.

這是否意味著您不是在關注這一點來管理業務以實現底線增長，而是更多地關注研發投資和資本配置，或者您如何看待這一點。

That's what I was trying to say in my introduction. I think it's fundamentally important that we are watching the cash flow very carefully. That is something that is truly important that we can finance our own investments in our own research by ourselves. And then we are looking at every opportunity to create value through drug product development.

這就是我在介紹中想說的。我認為我們非常仔細地觀察現金流是非常重要的。這是真正重要的事情，我們可以自己為自己的研究投資提供資金。然後我們正在尋找通過藥物產品開發創造價值的每一個機會。

If we see opportunities that are reasonable we will do them even if it has an impact on the short-term profitability over the next few quarters because it's absolutely clear to us that it's the best interest of all our investors. We are in the phase of cancer discovery and cancer development where we can see that opportunities are available today and maybe they will not be there tomorrow. We will be looking at a case-by-case on the quality of the assets that we have in our pipeline and when we see opportunity to develop then we will do that.

如果我們看到合理的機會，即使它對未來幾個季度的短期盈利能力有影響，我們也會去做，因為我們非常清楚，這符合我們所有投資者的最大利益。我們正處於癌症發現和癌症發展的階段，我們可以看到今天有機會，明天可能就沒有機會了。我們將逐案研究我們管道中資產的質量，當我們看到開發機會時，我們就會這樣做。

Thank you.

謝謝。

Ying Huang, Bank of America Merrill Lynch.

Ying Huang，美銀美林。

Good morning thanks for taking my questions.

早上好，謝謝你回答我的問題。

My first one is regarding to the PD-1 enrollment suspension. Hypothetically, if you have to discontinue the PD-1 I wonder what you could do with the GITR and OX40 program? Do you need to seek another PD-1 to combine with those I-O assets.

我的第一個問題是關於 PD-1 註冊暫停。假設，如果你必須停止 PD-1，我想知道你可以用 GITR 和 OX40 程序做什麼？你需要尋找另一個 PD-1 來與那些 I-O 資產結合嗎？

Then secondly, I want to ask about a potential event strategy for non-small cell lung cancer.

其次，我想問一下非小細胞肺癌的潛在事件策略。

We have seen that the PD-1 antibodies are quickly becoming a first-line therapy in non small cell lung cancer, and we know that from your Phase 1 data epacadostat as, I believe, it does not have activity in experienced patients who have already had PD-1 treatments. In that case how would you develop an I-O inhibitor in non small cell lung cancer?

我們已經看到 PD-1 抗體正迅速成為非小細胞肺癌的一線療法，並且我們從你們的 1 期數據中了解到 epacadostat，因為我相信，它在已經接受過治療的有經驗的患者中沒有活性接受過 PD-1 治療。在那種情況下，您將如何開髮用於治療非小細胞肺癌的 I-O 抑製劑？

Thank you.

謝謝。

Ying hi, it's Steven Stein. Thanks for your questions.

你好，我是史蒂文斯坦。感謝您的提問。

Firstly as regards PD-1 1210 that is an enrollment hold on new patients as we perform an assessment of the compounds profile in totality. We've made no further decisions related to the compound. I take it your question was a hypothetical, but going forward across programs including GITR, OX40 etc. We are looking at multiple potential partners in terms of PD-1 and PDL-1's.

首先，關於 PD-1 1210，當我們對化合物的總體概況進行評估時，它是對新患者的登記。我們沒有做出與化合物相關的進一步決定。我認為你的問題是假設性的，但在包括 GITR、OX40 等在內的項目中向前推進。我們正在尋找 PD-1 和 PDL-1 方面的多個潛在合作夥伴。

In terms of non-small cell lung cancer your right, it is a dynamic field that changes rapidly and certainly in the first-line setting testing for a biomarker and levels of expression look to be important for PD-1 therapies and then the chemotherapy combinations, as well. In terms of our own data in lung cancer that we're busy gathering data at the moment across our collaborations.

就非小細胞肺癌而言，你的權利，這是一個快速變化的動態領域，當然在生物標誌物的一線設置測試中，表達水平看起來對 PD-1 療法很重要，然後是化學療法組合，還有。就我們自己的肺癌數據而言，我們目前正忙於通過合作收集數據。

We will have patients, and many patients, who have not experienced any immunotherapy yet. We are positioned to be able to answer the question of whether or not we add to PD-1 activity in those settings. We are perfectly positioned to answer that question, actually.

我們會有很多患者，他們還沒有經歷過任何免疫治療。我們的定位是能夠回答我們是否在這些設置中添加 PD-1 活動的問題。實際上，我們完全有能力回答這個問題。

Thank you Steve.

謝謝史蒂夫。

Ian Somaiya, BMO Capital.

BMO Capital 的 Ian Somaiya。

Thanks. Just had a couple of questions.

謝謝。只是有幾個問題。

The first one on Jakafi. I guess after having five years of the myelofibrosis market all to yourself, just try to get a better understanding of what the future growth opportunity is within that indication, and how we should think about momelotinib if the Phase 1/2 data is reflective of the drugs commercial profile.

Jakafi 上的第一個。我想在自己擁有五年的骨髓纖維化市場之後，試著更好地了解該適應症的未來增長機會，以及如果 1/2 期數據反映了我們應該如何考慮 momelotinib藥物商業概況。

Then separately on IDO, Steven or Reid maybe you can just speak to how predictive melanoma data has been when considering success in solid tumors. I know you can't speak to your own data but maybe just the I-O field overall, whether it's marketed drugs or other drugs in development, that would just guide us to how to think about other drugs success in melanoma and whether they were specific tumor types that tended to respond similarly?

然後分別在 IDO、Steven 或 Reid 上，也許你可以談談在考慮實體瘤的成功時預測黑色素瘤數據的情況。我知道你不能談論你自己的數據，但也許只是 I-O 領域的整體，無論是上市藥物還是其他正在開發的藥物，這只會指導我們如何考慮其他藥物在黑色素瘤中的成功以及它們是否是特定腫瘤傾向於做出相似反應的類型？

Hi it's Barry.

嗨，我是巴里。

To answer your first question about Jakafi's growth, well the way we look at it is that we really only penetrated myelofibrosis about one third of the prevalence patient population, so we think we have an upside there.

要回答關於 Jakafi 增長的第一個問題，我們看待它的方式是，我們實際上只滲透了大約三分之一的流行病患者的骨髓纖維化，所以我們認為我們在那裡有優勢。

In terms of if momelotinib comes to market there's a couple of different scenarios one is that they in fact have a second line indication after Jakafi and we really don't think that this is going to have an impact on us. If they come to market in the front-line setting where Jakafi's currently approved, the way I think about it is that we have long-term data with long-term spleen response, we have improved symptoms, and we have an overall survival advantage and we don't cause neurotoxicity.

就 momelotinib 是否進入市場而言，有幾種不同的情況，一種是他們實際上在 Jakafi 之後有二線適應症，我們真的認為這不會對我們產生影響。如果他們在 Jakafi 目前批准的一線環境中上市，我認為我們有長期脾臟反應的長期數據，我們改善了症狀，我們有整體生存優勢和我們不會引起神經毒性。

I think our competitor profile again, will match up very well with Jakafi. And we continue to see not only are we adding more patients every single quarter, just like we did this quarter in myelofibrosis, but in fact those patients continue to benefit for a long time on Jakafi.

我認為我們的競爭對手概況再次與 Jakafi 相匹配。我們繼續看到，我們不僅每個季度都在增加更多的患者，就像我們本季度在骨髓纖維化方面所做的那樣，而且事實上，這些患者在很長一段時間內繼續受益於 Jakafi。

This is Reid I will take your second question.

我是里德，我會回答你的第二個問題。

I think as a field we've come to appreciate that melanoma is a very attractive proving ground to test immune-based therapies and that's true across all classes. It is a more inflamed tumor type, so there's an active component of T-cells. It certainly has a high mutational burden and all those things lend itself to being perhaps a lower bar, if you will, for immune-based therapies.

我認為作為一個領域，我們已經開始意識到黑色素瘤是一個非常有吸引力的試驗場，可以測試基於免疫的療法，而且所有類別都是如此。它是一種更易發炎的腫瘤類型，因此含有 T 細胞的活性成分。它肯定具有很高的突變負擔，所有這些因素都有助於降低基於免疫療法的門檻（如果您願意的話）。

Exactly how that predicts response across other tumor types, or whether it does, is probably a class specific question. It's certainly has shed new light, I think, from the field to understand which other tumor types may also harbor some of those characteristics of an inflamed phenotype and we can think about tumor types like bladder, lung, head and neck, renal cell, all in a new light because of the groundbreaking work that's happened in melanoma.

究竟如何預測其他腫瘤類型的反應，或者是否預測反應，可能是一個特定類別的問題。我認為，這無疑從該領域揭示了新的亮點，以了解哪些其他腫瘤類型也可能具有炎症表型的一些特徵，我們可以考慮膀胱、肺、頭頸、腎細胞等腫瘤類型由於在黑色素瘤中發生的開創性工作，從新的角度來看。

As we look at the emerging IDO data, certainly the signal that we reported at ESMO that formed the basis of our Phase 3 ECHO-301 program are important, I think, to having a derisking of the program. How or whether that translates to other tumor types is all going to be dependent on the data that we are generating. But I would say it increases our confidence; it doesn't decrease our confidence certainly, and coupled with the safety profile if we think about the emerging doublets landscape and some of the other tumor types, an attractive safety profile is going to be more not less important as the therapies move into early line in front-line settings.

當我們查看新出現的 IDO 數據時，我認為，我們在 ESMO 上報告的構成我們第 3 階段 ECHO-301 計劃基礎的信號對於降低該計劃的風險非常重要。如何或是否將其轉化為其他腫瘤類型都將取決於我們生成的數據。但我會說這增加了我們的信心；這當然不會降低我們的信心，如果我們考慮新興的雙胞胎景觀和其他一些腫瘤類型，再加上安全性，隨著治療進入早期階段，有吸引力的安全性將變得更加重要。在前線設置中。

So, I think we're encouraged based on those data. We are excited by the program. But we still have to generate the data that speaks precisely to what the opportunity may be outside of melanoma.

所以，我認為我們基於這些數據而受到鼓舞。我們對該計劃感到興奮。但我們仍然必須生成能夠準確說明黑色素瘤之外可能存在的機會的數據。

Thank you. Simos Simeonidis, RBC Capital Markets.

謝謝。 Simos Simeonidis，RBC 資本市場。

Good morning guys thanks for taking my question.

早上好伙計們，謝謝你提出我的問題。

Just to clarify in terms of news flow what can we expect for epacadostat announcements? You mentioned that we're going to see additional proof of concept data sometime first half of next year. But is it still the case that we may see an announcement or announcements about your plans, which tumor types you may go into Phase 3 earlier than that?

只是為了在新聞流方面澄清我們對 epacadostat 公告的期望是什麼？你提到我們將在明年上半年的某個時候看到更多的概念數據證明。但是，我們是否仍然會看到有關您的計劃的一個或多個公告，您可能會比那更早進入第 3 期的腫瘤類型？

Secondly could it be the case where you can have multiple announcements? For example, you can say going to go into lung, and then a month later you say we're going into this other tumor types, or will it all be one announcement for your Phase 3 plans?

其次，是否可以發布多個公告？例如，你可以說要進入肺部，然後一個月後你說我們要進入其他腫瘤類型，或者這將是你的 3 期計劃的一個公告？

Herve here, let me try to take that I mean we have tried to describe it in the past and we are precisely where -- the way we described it, which is a obviously a disclosure of the data at conferences is not entirely under our control because the dates of the conferences are set with larger intervals in between. If we are the point of making a decision to go to Phase 3 we think we think it's an advance that should be disclosed. So we would at this time announce it as we have done -- I think I remember waiting to get of the melanoma study, and that's really what's driving the process.

在這裡，讓我試著理解，我的意思是我們過去曾試圖描述它，而我們恰恰是——我們描述它的方式，這顯然是在會議上披露數據並不完全在我們的控制之下因為會議的日期之間的間隔較大。如果我們決定進入第 3 階段，我們認為我們認為這是一個應該披露的進步。所以我們現在會像我們所做的那樣宣布它——我想我記得等待黑色素瘤研究，這才是推動這一進程的真正原因。

I don't think we would be in a position where all the data from all the Phase 2 are going to be available at the same time. In fact we are just starting some new indications in some of these combinations, so you cannot expect that all of these studies are going to close at one point and then boom the whole set of data will be available. I think it will be more in batches as we are progressing through the first half of next year and that's really the situation we are facing here.

我認為我們不會同時獲得所有第 2 階段的所有數據。事實上，我們只是在其中一些組合中開始了一些新的適應症，所以你不能指望所有這些研究都會在一個時間點結束，然後整個數據集都會可用。我認為隨著我們在明年上半年取得進展，這將分批進行，這確實是我們在這裡面臨的情況。

Okay perfect and finally, has there been any impact in your Phase 2 trials by the durvalumab partial hold?

好的，最後，durvalumab 部分暫停對你們的 2 期試驗有影響嗎？

Hello it's Steven Stein, so in terms of head and neck cancer and what happened there, it is something we were aware of. We obviously have a clinical collaboration with AstraZeneca. The impact on the protocols will involve wording changes for people to exercise appropriate cautions for things like, for example, if the tumor is close to a major vessel. In addition if there's an underlying bleeding disorder.

你好，我是 Steven Stein，就頭頸癌和那裡發生的事情而言，這是我們所知道的。我們顯然與阿斯利康有臨床合作。對協議的影響將涉及措辭變化，以便人們對諸如腫瘤靠近主要血管等情況採取適當的謹慎措施。此外，如果存在潛在的出血性疾病。

In terms of our actual protocols and program, that continues unabated. It's just learnings from their experience and then an avoidance to try and have that toxicity not happen on our programs.

就我們的實際協議和計劃而言，這種情況有增無減。這只是從他們的經驗中學習，然後避免嘗試讓這種毒性不發生在我們的計劃中。

Great thank you.

太好了謝謝。

Geoff Meacham, Barclays.

Geoff Meacham，巴克萊銀行。

Hey all this is Evan Seigerman on for Geoff. Thanks for taking my question.

嘿，這一切都是 Evan Seigerman 為 Geoff 做的。感謝您提出我的問題。

Just a follow-up on kind of the IDO timelines in lung. I believe last week Merck mentioned that it would be in a position to make the go notice -- go decision on Phase 3 by mid-2017. Is this still in line with your assumptions and how often and how much do you look at the data on an ongoing basis to help you make this choice? Thank you.

只是對肺部 IDO 時間線的一種跟進。我相信上週默克公司提到它將能夠發出通行通知——在 2017 年年中之前就第 3 階段做出通行決定。這是否仍然符合您的假設以及您持續查看數據的頻率和數量以幫助您做出此選擇？謝謝。

As we said I would think -- as we said the ability to make a decision is not just based on the response rate data, it's based on the duration of response. It's based on the biomarkers specifically in lung cancer, where as you know things have changed a little bit of a past few months with new emerging data from PD-1 as a single agent. I think Merck comments about mid-2017, and we speak about the first half of 2017, so that's probably very much overlapping from that standpoint.

正如我們所說，我會認為——正如我們所說，做出決定的能力不僅基於響應率數據，還基於響應的持續時間。它基於專門針對肺癌的生物標誌物，如您所知，過去幾個月隨著 PD-1 作為單一藥物出現的新數據發生了一些變化。我認為默克公司評論的是 2017 年年中，而我們談論的是 2017 年上半年，所以從這個角度來看，這可能有很多重疊。

We don't know exactly when it would be, because as I said this is data that is emerging. The database that will be populated to make the decision with the partner is not yet populated. So we don't have access to that data with the full set of biomarker, duration of response, and response rates yet and when we have it is really where we will be able to move to the next step.

我們不知道確切的時間，因為正如我所說，這是正在出現的數據。將填充以與合作夥伴一起做出決定的數據庫尚未填充。因此，我們還無法訪問包含全套生物標誌物、反應持續時間和反應率的數據，當我們擁有這些數據時，我們才能真正進入下一步。

Great. Thanks for taking the questions appreciate it.

偉大的。感謝您提出問題。

Eric Schmidt, Cowen and Company.

埃里克施密特，考恩公司。

Good morning, another question on epacadostat for Herve.

早上好，Herve 關於 epacadostat 的另一個問題。

From the time you would make a go decision on a pivotal study, how long would it take to actually start such a trial, and would that change if you were doing it with or without a partner? I ask because I think it took a good six to nine months in melanoma and I'm wondering if you could shorten that timeline?

從你對一項關鍵研究做出決定開始，實際開始這樣的試驗需要多長時間，如果你在有或沒有合作夥伴的情況下進行，這會改變嗎？我問是因為我認為黑色素瘤花了六到九個月的時間，我想知道你是否可以縮短這個時間表？

I think the decision to work with a partner on that is really something that we are looking at this in a natural way that we tend to like to work with a partner; it has a small financial impact on the cost of the study. But it's also a way to learn and benefit from their own scientific understanding of their own product.

我認為與合作夥伴合作的決定實際上是我們以一種自然的方式看待這個問題，我們傾向於喜歡與合作夥伴合作；它對研究費用的財務影響很小。但這也是一種學習和受益於他們對自己產品的科學理解的方式。

It's not just a financial benefit of working with a partner, there is a little bit of a shared scientific information. If for any reason a partner would rather not be part of the study, which could happen for budget reasons or for any other external reason, we are always open to do the study by ourselves.

與合作夥伴合作不僅僅是經濟上的好處，還有一點點共享的科學信息。如果合作夥伴出於任何原因不願參與研究，這可能是出於預算原因或任何其他外部原因，我們始終願意自己進行研究。

In terms of the timing I think last time the announcement was made at the point where we were in the planning stage, so maybe took a little bit of time to go through the entire planning, protocol writing, and then execution. In general what we tend to see the window between the decision to do a Phase 3 and the first patient in the Phase 3 to be less than six months.

就時間而言，我認為上次宣布是在我們處於計劃階段的時候發布的，所以可能花了一點時間來完成整個計劃、協議編寫和執行。總的來說，我們傾向於看到從決定進行第 3 階段到第 3 階段的第一個患者之間的時間間隔小於六個月。

That would be an industry-standard.

那將是一個行業標準。

Thank you.

謝謝。

Liisa Bayko, JMP Securities.

JMP 證券公司的 Liisa Bayko。

Hello, there. I was wondering if you talk a little bit about R&D. I know you've increased how much are going to be spending this year. Just curious where you're spending where you hadn't accounted before where you're placing more dollars?

你好呀。我想知道你是否談談研發。我知道你已經增加了今年的支出。只是想知道在投入更多美元之前，您在沒有記賬的地方花費了什麼？

Thank you.

謝謝。

The importance of the R&D spending -- we are a company that is fully integrated, so we have a relatively large team working in chemistry and biology and doing discovery every day, in fact. That's a piece of it.

研發支出的重要性——我們是一家完全整合的公司，所以我們有一個相對較大的團隊從事化學和生物學工作，實際上每天都在進行發現。這是它的一部分。

I don't know if we have given details on the split between the different cost structure. But you can imagine that that part is mostly internal costs. So there basically head counts that are working on our projects. And then on the D side, the Development side, Steven Stein's group, we have a mix of internal costs. So we have a team of people that has been increased fairly substantially over the past three years and we have obviously a number of costs that are study-related. So they are directly attached to the number of patients that we are accruing in our studies.

我不知道我們是否詳細說明了不同成本結構之間的劃分。但是你可以想像那部分主要是內部成本。所以基本上有人數在我們的項目上工作。然後在 D 方面，開發方面，Steven Stein 的團隊，我們有內部成本的組合。因此，我們的團隊在過去三年中大幅增加，而且我們顯然有許多與研究相關的成本。因此，它們與我們在研究中積累的患者數量直接相關。

That's sort of the way it works. The way it gives us is some flexibility understanding depending on the cycle of study. So as we discussed earlier, if we were initiating a number of Phase 3 studies, we could do it. We have the infrastructure to do it. And that would increase the external cost attached to this Phase 3 studies. If we have less commitment to studies ongoing at some point in time, then the external costs can go down and we have created in our systems the flexibility to do that.

這就是它的工作方式。它給我們的方式是根據學習週期靈活理解。因此，正如我們之前討論的那樣，如果我們啟動多項 3 期研究，我們就可以做到。我們有基礎設施來做到這一點。這將增加與該第 3 階段研究相關的外部成本。如果我們在某個時間點減少對正在進行的研究的投入，那麼外部成本就會下降，我們已經在我們的系統中創造了這樣做的靈活性。

The growth of our current R&D budget is mostly driven by the external costs related to the studies, as we have now built the team that is of a good-size to be able to manage this project. I guess that's what I can say about the confidence of the R&D budget.

我們目前研發預算的增長主要是由與研究相關的外部成本推動的，因為我們現在已經建立了能夠管理該項目的規模龐大的團隊。我想這就是我對研發預算信心的看法。

Great and then just kind of two programs that don't get as much attention. But the GVHD and alopecia; can you just remind us of dosing and briefly what are you looking for in the data to show that there's a strong signal.

很棒，然後只是兩個沒有得到太多關注的程序。但 GVHD 和脫髮；你能不能提醒我們劑量，並簡要說明你在數據中尋找什麼來表明有一個強烈的信號。

Thanks.

謝謝。

Yes hi, Steven Stein answering your question.

是的，您好，Steven Stein 正在回答您的問題。

On graft versus host disease there are a few entities there. There's acute graft versus host disease and chronic graft versus host disease, and then there is steroid refractory components, and then there's a first-line entity in acute that's not yet steroid refractory. So you just have to be careful about the entities you're talking about and the clinical manifestations in each of those can be different. And because of acuity of disease and needing to control it early that can also mean slightly different things.

關於移植物抗宿主病，那裡有一些實體。有急性移植物抗宿主病和慢性移植物抗宿主病，然後是類固醇難治性成分，然後是急性的一線實體，它還不是類固醇難治性的。所以你只需要小心你正在談論的實體，並且每個實體的臨床表現都可能不同。並且由於疾病的嚴重性和需要及早控制它，這也可能意味著略有不同的事情。

We have not yet disclosed the dosing we use in any of these programs yet, but when they started starts and go up on www.clinicaltrials.gov more information will be available. But they are not -- they are in keeping with what we know about ruxolitinib's profile and what it can do. For alopecia areata, just reminded of the topical ruxolitinib formulation, a cream and would need going forward potentially more dose range and work to work out exactly the dose to deliver there.

我們尚未披露我們在任何這些計劃中使用的劑量，但當它們開始並在 www.clinicaltrials.gov 上發佈時，將提供更多信息。但它們不是——它們與我們對 ruxolitinib 的概況及其作用的了解保持一致。對於斑禿，只是提醒了外用 ruxolitinib 配方，一種乳膏，可能需要進一步擴大劑量範圍，並努力計算出在那裡輸送的準確劑量。

Okay. And then just final question, any inside you can give us on baricitinib, obviously it's a large market opportunity and I think the ranges out there are pretty broad. Has Lilly provided any guidance on how they're thinking of competing in that market? Is it going to be a priced to take share strategy or more of a premium pricing? How should we think about where it falls into the regimens available?

好的。然後是最後一個問題，你可以在 baricitinib 上給我們任何內部信息，顯然這是一個巨大的市場機會，我認為那裡的範圍非常廣泛。禮來公司是否就他們如何考慮在該市場競爭提供了任何指導？是採取股票策略定價還是溢價定價？我們應該如何考慮它屬於可用方案的哪些部分？

Thanks for the question. It's difficult to answer, because our partner Lilly is really driving a lot of the strategy for the launch and they have not been communicating, obviously, all the details of their strategy. So it will not be appropriate for me to speak about it.

謝謝你的問題。很難回答，因為我們的合作夥伴 Lilly 確實在推動很多發布戰略，而且他們顯然沒有溝通他們戰略的所有細節。所以我不適合談論它。

What we see is that the profile of baricitinib from the multiple Phase 3 studies that have been performed is it certainly very good when compared to the TNFs. So that certainly something that would be core to the strategy of the product. Because that's where the medical profile is driving a lot of the decisions that will be made there. We know the review process is ongoing and the target dates that have been discussed is early next year. So that's really what we can say on baricitinib.

我們看到的是，與 TNF 相比，已經進行的多項 3 期研究中巴瑞替尼的概況肯定非常好。所以這肯定是產品戰略的核心。因為那是醫療概況推動將在那裡做出的許多決定的地方。我們知道審查過程正在進行中，並且已經討論過的目標日期是明年初。所以這就是我們在 baricitinib 上可以說的。

Okay. Thanks a lot for the questions.

好的。非常感謝您的提問。

Brian Abrahams, Jefferies.

布賴恩亞伯拉罕，傑富瑞。

Hello. Thanks for taking my question and congrats on the strong quarter. On the fourth-quarter -- on 2016 Jakafi growth, I wonder if you could talk about the drivers for fourth-quarter growth. I think based on the midpoint of your guidance it looks like you're expecting both absolute and percentage quarter-over-quarter increase to be less than fourth-quarter or third quarter, as compared to third quarter over second quarter despite a price increase that you took at the end of the third quarter. It sounds like there weren't any one-time factors that contributed to third-quarter growth. I'm just wondering if you are expecting maybe lesser price in pull through, perhaps a slight waning of demand growth, or maybe you're just being conservative?

你好。感謝您提出我的問題並祝賀強勁的季度。關於第四季度——關於 2016 年 Jakafi 的增長，我想知道你是否可以談談第四季度增長的驅動因素。我認為，根據您的指導意見的中點，與第三季度和第二季度相比，儘管價格上漲你在第三季度末拿下了。聽起來好像沒有任何一次性因素促成了第三季度的增長。我只是想知道您是否預計價格可能會降低，需求增長可能會略有減弱，或者您只是保守？

Then separately on the development side, where do you foresee epacadostat potentially fitting into relative to checkpoint plus chemo combos, just wondering if you could potentially move straight into any Phase 3's on top of chemo in a PD-1, if you wanted to go that route? Or would you need additional Phase 2 work before you took that step?

然後分別在開發方面，你在哪裡預見 epacadostat 可能適合相對於檢查點加化療組合，只是想知道你是否有可能直接進入 PD-1 化療之上的任何第 3 階段，如果你想去那個路線？或者在採取該步驟之前，您是否需要額外的第 2 階段工作？

Thanks.

謝謝。

Thanks, Brian. This is Barry, I'll answer the first question.

謝謝，布萊恩。我是巴里，我來回答第一個問題。

We think it's prudent to our guidance going forward $850 million represents a 5% quarter-over-quarter growth and goes up to 7% quarter-over-quarter growth at $855 million, so we think that's good. Mostly the fourth quarter is one of those quarters that you don't know exactly what's going to happen, lots of vacation days and time off for healthcare professionals and for our staff in November and December.

我們認為我們對未來的指導是謹慎的，8.5 億美元代表環比增長 5%，環比增長 7%，達到 8.55 億美元，所以我們認為這很好。大多數情況下，第四季度是您不知道會發生什麼的那些季度之一，醫療保健專業人員和我們的員工在 11 月和 12 月有很多假期和休假。

Historically Jakafi has had very good fourth quarters and some soft fourth quarters. So that's why were putting out guidance like that. But we still have lots of enthusiasm for continued growth in both MF and PV.

從歷史上看，Jakafi 有過非常好的第四節和一些軟弱的第四節。所以這就是我們發布這樣的指導的原因。但我們仍然對 MF 和 PV 的持續增長充滿熱情。

Brian hi, it's Steven Stein.

布萊恩嗨，我是史蒂文斯坦。

In related to the chemotherapy question both in combination with checkpoint inhibitors, there are at least two questions that we will answer in our clinical program going forward. One is does a PD-1 or PDL-1 plus IDO perform similarly or better to a PD-1 or PDL-1 combo plus chemo?

關於聯合檢查點抑製劑的化療問題，我們將在未來的臨床計劃中至少回答兩個問題。一個是 PD-1 或 PDL-1 加 IDO 的表現是否與 PD-1 或 PDL-1 組合加化療相似或更好？

Then the other one we are very interested in answering and we will begin clinical work shortly is adding IDO to a chemotherapy combination in multiple different histologies and multiple different chemotherapy combinations. There is a lot of good science there around what chemotherapy can potentially do in terms of neo-antigen release etc. But those -- that latter question, we still need more clinical work to answer to get to meet your question.

然後另一個我們非常有興趣回答並且我們將很快開始臨床工作的是將 IDO 添加到多種不同組織學和多種不同化學療法組合的化學療法組合中。關於化療在新抗原釋放等方面的潛在作用，有很多很好的科學依據。但是那些 - 後一個問題，我們仍然需要更多的臨床工作來回答才能回答你的問題。

In terms of a tolerability profile, that is something else which we will obviously carefully examine, because the PD-1 plus IDO combo as you know, and we just presented updated data at ESMO very well-tolerated. And then the different tolerance for a chemotherapy combination; so to be continued and to be answered over the ensuing year.

就耐受性概況而言，這是我們顯然會仔細檢查的另一件事，因為如您所知，PD-1 加 IDO 組合，我們剛剛在 ESMO 上展示了耐受性非常好的更新數據。然後是對化療組合的不同耐受性；因此將在接下來的一年中繼續並得到答复。

Thanks very helpful.

謝謝很有幫助。

Ren Benjamin, Raymond James.

任本傑明，雷蒙德詹姆斯。

Hello good morning thanks for taking my questions and congratulations on the great quarter.

你好，早上好，感謝你提出我的問題，並祝賀這個偉大的季度。

Maybe just going back to epacadostat, can you give us a sense as to what studies we might see first, and is it as easy as kind of going back and looking at when these studies have started, or are there different enrollment challenges that are taking place with a variety of studies?

也許只是回到 epacadostat，你能告訴我們我們可能首先看到哪些研究嗎？它是否就像回顧並查看這些研究何時開始一樣簡單，或者是否存在不同的入學挑戰有各種研究的地方？

The other question is again, related to the PD-1 inhibitor, Steve did enrollment complete, and now you are assessing the efficacy of the drug or was there some signal that forced you to stop mid-enrollment?

另一個問題又是，關於 PD-1 抑製劑，史蒂夫確實完成了入組，現在你正在評估藥物的療效，還是有一些信號迫使你中途停止入組？

Just a high level question for Herve, just given the current climate regarding price increases, can you maybe talk a little bit about how you are planning to, or handling this going forward, and are there any rumblings from payors? Or does that really just happen once there's a competitor on the market? Thanks.

對於 Herve 來說，這是一個高層次的問題，考慮到當前價格上漲的情況，你能否談談你打算如何或如何處理這件事，付款人是否有任何傳聞？還是一旦市場上出現競爭對手，這種情況就真的會發生？謝謝。

Ren, hi it's Steven Stein I will take your first two questions then hand it over to Herve.

Ren，嗨，我是 Steven Stein，我會回答你的前兩個問題，然後交給 Herve。

The first one I'm not going to answer satisfactory for you because it depends on histology and when they come in in terms of the data sets. We will, and we've said repeatedly, across our collaborations, we studied more than a dozen tumors. We will enroll north of 600 patients this year and have very healthy cohorts for each of those to analyze.

第一個我不會讓你滿意，因為它取決於組織學以及它們何時進入數據集。我們會，而且我們一再說過，在我們的合作中，我們研究了十幾種腫瘤。今年我們將招募超過 600 名患者，並為每個患者提供非常健康的隊列進行分析。

Some areas are more competitive than others. These are known areas like lung cancer can be more competitive than other histologies. I'm not going to comment as to what data sets will come in first before others, and as Herve said earlier we'll present them appropriately.

有些領域比其他領域更具競爭力。這些是已知的領域，例如肺癌可能比其他組織學更具競爭力。我不會評論哪些數據集會先於其他數據集出現，正如 Herve 早些時候所說，我們會適當地展示它們。

In terms of your question related to our PD-1 1210 inhibitor the dose escalation phase completed and we have information to make decisions on what to go forward in terms of dose expansion. And that's what we're looking at the totality of the profile at the moment.

關於您與我們的 PD-1 1210 抑製劑相關的問題，劑量遞增階段已經完成，我們有信息可以就劑量擴展方面的進展做出決定。這就是我們目前正在查看的整體配置文件。

I will hand it to Herve.

我會把它交給 Herve。

In the question about the climate on price, I think -- again, I mean back to what I said at the beginning of the quarter. I think our view is that innovation is what creates value, it creates value for society it creates value for patients, obviously, first, by where we can help and you see that now.

在關於價格氣候的問題中，我認為——再次，我的意思是回到我在本季度初所說的話。我認為我們的觀點是，創新是創造價值的東西，它為社會創造價值，它為患者創造價值，顯然，首先，我們可以提供幫助，你現在看到了。

You see a number of tumor types where physically a diagnosis just of years ago people were looking at palliative ways to treat these patients, and where there are now there are option is to potentially have some curative or very long-term responses, and that's really what's driving most all of our efforts in bringing these new drugs to market. What it does to society is an incredible amount of savings on the cost of treating cancer. And that's really where the economics work really well, is that today most of the cost of treating cancer -- 80% of it in the US and around the same number in Europe, are not coming from medicines. They're coming from the rest of the cost in surgery and palliative care, radiation therapy etc.

你會看到許多腫瘤類型，幾年前人們還在尋找治療這些患者的姑息方法，而現在有一些選擇是可能有一些治愈或非常長期的反應，這真的是什麼促使我們竭盡全力將這些新藥推向市場。它為社會所做的是在治療癌症方面節省了大量的費用。而這正是經濟學真正發揮作用的地方，即今天治療癌症的大部分費用——其中 80% 在美國和大約相同數量的歐洲，都不是來自藥物。它們來自手術和姑息治療、放射治療等的其餘費用。

So the model we are pursuing is the model that will be over time obviously building for us an importance source of new revenues through innovative products and at the same time being able to make it in such a way where the healthcare system will benefit from this innovation, and we see that. I know there is a lot of noise about the way people look at some of the cost issues. But the reality is that we see already that when products are truly effective they are in fact cost savings for the healthcare system.

因此，我們正在追求的模型顯然會隨著時間的推移通過創新產品為我們建立重要的新收入來源，同時能夠使醫療保健系統從這種創新中受益，我們看到了。我知道人們對某些成本問題的看法存在很多爭議。但現實情況是，我們已經看到，當產品真正有效時，它們實際上可以為醫療保健系統節省成本。

In the case of Jakafi in myelofibrosis, it's a situation where we are in a position where the coverage in the US is very broad and we don't see a lot of hurdles there. Obviously it's based on what Barry was describing where the symptomatic benefits and now the survival benefit is well established for this product.

就骨髓纖維化中的 Jakafi 而言，我們所處的情況是美國的覆蓋範圍非常廣泛，我們在那裡沒有看到很多障礙。顯然，它是基於 Barry 所描述的症狀益處以及現在該產品的生存益處已經確定的內容。

Thank you.

謝謝。

Peter Lawson, SunTrust Robinson Humphrey.

Peter Lawson，SunTrust Robinson Humphrey。

A question for Barry or Steven just around the ASH data. What could we see -- it looks like what Jakafi five-year data GVHD, any color around that data?

一個關於 ASH 數據的問題，請問 Barry 或 Steven。我們能看到什麼——它看起來像什麼 Jakafi 五年數據 GVHD，數據周圍有什麼顏色？

Hello, Peter. It's Steven Stein.

你好，彼得。是史蒂文·斯坦。

As you know, the American Society of Hematology abstract published in the next 24 to 48 hours, and I'm embargoed until then. So I can't give you color around the data, other than to point to what we said in the actual presentation, which is the pooled analysis of COMFORT-1 and -2 overall survival data in myelofibrosis will be presented as part of our numerous presentations at ASH.

如您所知，美國血液學會摘要將在接下來的 24 到 48 小時內發表，而我在此之前一直處於禁運狀態。所以我不能給你圍繞數據的顏色，除了指出我們在實際演示中所說的，這是對骨髓纖維化中 COMFORT-1 和 -2 總體生存數據的匯總分析，將作為我們眾多的一部分呈現在 ASH 的演講。

Then additionally 39110 our selective JAK-1 inhibitor proof of concept study in graft versus host disease will also be presented there. So as soon as the abstracts are live you can look at the data set in the actual presentations. I can't provide more color at this point.

然後另外 39110 我們的選擇性 JAK-1 抑製劑移植物抗宿主病概念驗證研究也將在那裡展示。因此，一旦摘要上線，您就可以在實際演示中查看數據集。我現在無法提供更多顏色。

Just in the earlier I-O pipeline, GITR and OX40, when can we see data around those molecules?

就在早期的 I-O 管道 GITR 和 OX40 中，我們什麼時候可以看到這些分子周圍的數據？

Steven again.

又是史蒂文。

The GITR program dosed early in the second half of this year and OX40 is about to dose, so we will be conducting those studies as efficiently as possible. But you are looking a year plus ahead to see data related to the Phase 1 experience for those compounds.

GITR 計劃在今年下半年早些時候開始給藥，OX40 即將給藥，因此我們將盡可能高效地進行這些研究。但是您期待一年多的時間才能看到與這些化合物的第一階段經驗相關的數據。

Thanks.

謝謝。

Alethia Young, Credit Suisse.

Alethia Young，瑞士信貸。

Hey guys. Thanks for squeezing me in. Congrats on the quarter.

大家好。謝謝你把我擠進來。祝賀這個季度。

This is probably for Barry. As it relates for Jakafi, with the broader guidelines is it a matter of finding the patients, or is it educating the doctors who are reviewing the charts around that opportunity?

這可能是給巴里的。就 Jakafi 而言，更廣泛的指導方針是尋找患者的問題，還是教育正在圍繞該機會審查圖表的醫生？

Sure so for myelofibrosis it is sometimes difficult. Myelofibrosis patients obviously are seen by hematologist, oncologist in the community and they may not see them as frequently as they do some metastatic lung cancer patients for example.

當然，對於骨髓纖維化來說，這有時很困難。很明顯，社區的血液學家、腫瘤學家會看到骨髓纖維化患者，他們可能不像某些轉移性肺癌患者那樣頻繁地看到他們。

So to recognize that these patients -- that patients that they might call low risk, let's say, but are actually high risk and they need to be treated right away, sometimes that's very difficult for them to assess. Our educational efforts -- some of our educational efforts are focused on that, to make sure that physicians who are treating patients with myelofibrosis are appropriately assessing the risk that these patients are under and the NCCN guidelines reinforce that.

因此，要認識到這些患者——他們可能稱之為低風險的患者，比方說，但實際上是高風險的，他們需要立即接受治療，有時他們很難評估。我們的教育工作——我們的一些教育工作專注於此，以確保治療骨髓纖維化患者的醫生適當評估這些患者所處的風險，NCCN 指南加強了這一點。

Then, just on momelotinib and looking at your longer-term data in COMFORT, do you think that the long-term data is something that is important to doctors? Meaning that, let's say, a bear case scenario comes out from momelotinib where the data looks like it supports a first-line therapy. Do you think that having that longer-term data is something that's very important and relevant and momelotinib would have to be held to the same standards?

然後，就 momelotinib 而言，看看您在 COMFORT 中的長期數據，您認為長期數據對醫生來說重要嗎？這意味著，比方說，莫美洛替尼出現了熊市情況，數據看起來支持一線治療。您是否認為擁有長期數據是非常重要和相關的，莫美羅替尼必須遵守相同的標準？

Yes exactly. That's why keep on saying our clinical profile matches up very well. We have long-term spleen response data, long-term safety data. We improved symptoms to a great degree for these patients, and in fact we have a 30% reduction in the risk of death. And there is no endpoint in the momelotinib studies, either Simplify one or Simplify two for overall survival. So we think we are in good shape.

對，就是這樣。這就是為什麼一直說我們的臨床資料非常匹配的原因。我們有長期的脾臟反應數據，長期的安全性數據。我們在很大程度上改善了這些患者的症狀，事實上我們將死亡風險降低了 30%。 momelotinib 研究沒有終點，無論是簡化一個還是簡化兩個總生存期。所以我們認為我們的狀態很好。

Great. Thanks.

偉大的。謝謝。

Michael Schmidt, Leerink Partners.

Leerink Partners 的邁克爾·施密特 (Michael Schmidt)。

Hey guys. Thanks for taking the follow-up.

大家好。感謝您的跟進。

I had a couple additional questions, one on duration of therapy in MF in clinical practice. Has that been similar to what's been seen in long-term follow-up of the COMFORT trials?

我有幾個額外的問題，一個是關於 MF 在臨床實踐中的治療持續時間。這是否與在 COMFORT 試驗的長期隨訪中看到的情況相似？

For myelofibrosis in the COMFORT trials, what you are talking about is that patients -- 50% of patients stayed on it for three years. While in the everyday setting, not in the clinical trial setting it's less than that. But it's hard to predict.

對於 COMFORT 試驗中的骨髓纖維化，你所說的是患者——50% 的患者堅持了三年。在日常環境中，而不是在臨床試驗環境中，它比這要少。但很難預測。

Patients stay on therapy for a long time. We have some percentage of patients who stay on therapy for a very long time and benefit greatly from it. So we've never really talked about the true persistency. But it's more than 12 months.

患者長期接受治療。我們有一定比例的患者長期接受治療並從中受益匪淺。所以我們從來沒有真正談論過真正的堅持。但是已經超過12個月了。

Great. Thanks.

偉大的。謝謝。

Then one of the FGFR inhibitor, the question there is whether the Phase 2 studies that you have initiated there, whether those could be registration enabling.

然後是 FGFR 抑製劑之一，問題是您在那裡啟動的 2 期研究是否可以註冊。

Michael, hi. It's Steven Stein responding. There are robust large Phase 2 studies of approximately 100 patients each. They will capture response rates along with duration of response. There are multiple precedents both in the United States and in Europe for approvals with good high response rates that are durable.

邁克爾，嗨。這是 Steven Stein 的回應。有強大的大型 2 期研究，每項研究大約有 100 名患者。他們將捕獲響應率以及響應持續時間。在美國和歐洲都有多個先例可以獲得持久的高響應率批准。

In the US it would be on the accelerated approval conditions, in Europe under conditional approval conditions, for which you would then have to do confirmatory studies. So it's a review issue based on the efficacy data we see. But there is potential.

在美國，它將處於加速批准的條件下，在歐洲，處於有條件的批准條件下，然後您必須為此進行驗證性研究。所以這是一個基於我們看到的療效數據的審查問題。但是有潛力。

Okay. And one on capmatinib, the MET inhibitor with Novartis where it looks like they are expecting filing in 2018. I was wondering whether it's known which specific indication that could be in? Is that a monotherapy approach in MET selected lung cancer patients, or potentially in combination with each of our inhibitors? Thank you.

好的。還有一個關於 capmatinib，Novartis 的 MET 抑製劑，看起來他們預計在 2018 年提交申請。我想知道它是否知道可能屬於哪個特定適應症？這是針對 MET 選擇的肺癌患者的單一療法，還是可能與我們的每種抑製劑聯合使用？謝謝。

Herve here, I think our understanding that it would be in lung cancer.

在這裡，我認為我們的理解是肺癌。

Any more color on the royalties and potential milestones from that program?

關於該計劃的版稅和潛在里程碑還有更多顏色嗎？

I think what we have said on the royalties is that there would be in the teens -- low teens, So 12% to 14%. And that's a milestone attached to different events like approval, et cetera, that we have not disclosed yet.

我想我們所說的版稅是十幾歲——十幾歲，所以 12% 到 14%。這是與批准等不同事件相關的里程碑，我們尚未披露。

Perfect. Thank you and congrats again on the quarter.

完美的。謝謝你，再次祝賀這個季度。

Okay.

好的。

Thank you. I will now turn the floor back to Mr. Herve Hoppenot for closing remarks thank you.

謝謝。我現在將發言權轉回 Herve Hoppenot 先生的閉幕詞，謝謝。

Okay. Thank you for your time today and for your questions. We look forward to seeing some of you at the ASH conference next month. But for now we thank you again for your participation in the call today. Thank you and goodbye.

好的。感謝您今天的時間和您的問題。我們期待在下個月的 ASH 會議上見到你們中的一些人。但現在，我們再次感謝您參與今天的電話會議。謝謝，再見。

This concludes today's call. All parties may disconnect have a great day.

今天的電話會議到此結束。各方都可能會斷開連接，祝你有美好的一天。