美國安進 (AMGN) 2016 Q2 法說會逐字稿

My name is Zirmarcus Ross, and I will be your conference facilitator today for Amgen's second quarter 2016 earnings conference call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speaker's prepared remarks.

我是齊爾馬庫斯·羅斯，今天我將擔任安進公司2016年第二季財報電話會議的主持人。所有線路均已靜音，以避免背景噪音。在最後一位發言人發言結束後，將進行問答環節。

(Operator Instructions)

（操作說明）

I would now like to introduce Arvind Sood, Vice President of Investor Relations, Mr. Sood, you may now begin.

現在我謹介紹投資者關係副總裁 Arvind Sood 先生，Sood 先生，您可以開始了。

Thank you, Zirmarcus. Good afternoon, everybody. I would like to welcome you to our conference call to discuss our second-quarter financial results. I would like to particularly extend a warm welcome to those who are new in their investment coverage of Amgen, including Ronny Gal and Vincent Chen of Bernstein.

謝謝 Zirmarcus。大家下午好。歡迎各位參加我們關於第二季財務表現的電話會議。我特別要熱烈歡迎兩位新加入安進投資研究團隊的專家，包括伯恩斯坦的 Ronny Gal 和 Vincent Chen。

Our second-quarter once again is a continuation of great execution of how we are effectively managing the life cycle of legacy products while launching new products. Of course there is much more to our execution, so to have that broader discussion, I am joined today by Bob Bradway, our Chairman and CEO, who will lead the call with a strategic overview.

第二季度，我們再次延續了在有效管理現有產品生命週期和推出新產品方面的出色執行力。當然，我們的執行力遠不止於此，為了更深入地探討這個問題，今天我邀請到了董事長兼首席執行官鮑勃·布拉德韋先生，他將主持本次電話會議，並帶來戰略概述。

Our CFO David Meline will then review our quarterly results and update you on our guidance for 2016. Following David, our Head of Global Commercial Operations Tony Hooper will discuss our product performance during the quarter, followed by our Head of R&D Sean Harper, who will provide a pipeline update. We should leave plenty of time for Q&A after Sean's comments.

接下來，我們的財務長大衛梅林將回顧季度業績，並向大家介紹我們2016年的業績展望。大衛之後，全球商業營運主管托尼·胡珀將討論本季產品表現，隨後研發主管肖恩·哈珀將介紹產品線最新進展。在肖恩發言後，我們將預留充足的時間進行問答環節。

Before I turn the call over to Bob, I would like to note that we have reviewed the Security and Exchange Commission's recent guidance regarding the use of non-GAAP financial measures, and our press release incorporates this revised guidance.

在將電話交給鮑伯之前，我想指出，我們已經審查了美國證券交易委員會最近關於使用非GAAP財務指標的指導意見，我們的新聞稿中也包含了這項修訂後的指導意見。

As in the past, we will use slides for our presentation today, which have been posted on our website, and a link was sent to you separately by email.

和以往一樣，我們今天將使用幻燈片進行演示，幻燈片已發佈在我們的網站上，連結已透過電子郵件單獨發送給您。

We plan on using non-GAAP financial measures in today's presentation to provide information which may be useful to understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results. Reconciliations of these measures are available in the schedule accompanying today's press release of Form 8-K, and also on the Investor Relations section of our website.

我們計劃在今天的演示中使用非公認會計準則（非GAAP）財務指標，以提供有助於了解我們持續業務表現的資訊。但是，這些非GAAP財務指標應與GAAP財務結果一併考慮。這些指標的調節表可在今天隨附的8-K表格新聞稿的附表中查閱，也可在我們網站的投資者關係欄位中找到。

Just a reminder that some of the statements made during the course of our presentation are forward-looking statements, and our 2015 10-K and subsequent filings identify factors that could cause our actual results to differ materially. With that, I would like to turn the call over to Bob. Bob?

再次提醒各位，我們在演示過程中所作的一些陳述屬於前瞻性陳述，我們在2015年提交的10-K表格及後續文件中列出了可能導致實際業績與預期存在重大差異的因素。接下來，我想把電話交給鮑伯。鮑伯？

Thank you, Arvind, and thank you all for joining our call. Our business continues to perform well. As you can see through the results the first six months of the year, with our revenues up 8%, and our adjusted earnings per share up 13%. While delivering strong and consistent quarter-to-quarter performance, we're also investing successfully for the long term, and the elements of our long-term strategy for growth are clearly progressing, as well.

謝謝Arvind，也謝謝各位參加本次電話會議。我們的業務持續表現良好。正如大家從上半年的業績報告中所見，我們的營收成長了8%，調整後每股盈餘成長了13%。在維持強勁且穩定的季度業績的同時，我們也成功地進行長期投資，我們長期成長策略的各項要素也正在穩步推進。

We launched six new products last year, two in the cardiovascular arena and four in cancer. These products are still in the early stages of their life cycle globally. We remain particularly excited about the long-term prospects of Repatha, and look forward to important clinical data set to emerge later this year and early next year, which we think will fully illuminate the value of this product.

去年我們推出了六款新產品，其中兩款針對心血管領域，四款針對癌症領域。這些產品在全球範圍內仍處於生命週期的早期階段。我們對瑞百安（Repatha）的長期前景特別看好，並期待今年稍後和明年年初公佈的重要臨床數據，我們相信這些數據將充分展現該產品的價值。

Kyprolis is also a top priority. Based on the very strong clinical profile of Kyprolis, we expect this product to be a backbone of multiple myeloma therapy for the foreseeable future, and as such for it to be used in combination with many of the new agents that are emerging in the field. Both of these products are making progress internationally, with additional regulatory approvals, and reimbursement negotiations proceeding well.

Kyprolis也是我們的首要任務。基於Kyprolis非常出色的臨床療效，我們預計該產品將在可預見的未來成為多發性骨髓瘤治療的基石，並因此與該領域湧現的許多新藥聯合使用。這兩種產品在國際上都取得了進展，獲得了更多監管部門的批准，醫保報銷談判也進展順利。

Behind the recent launches of our six drugs for cardiovascular disease and cancer, we have programs nearing key regulatory milestones in four other therapeutic areas: Neurology, where we are excited about Erenumab as a potential first-in-class therapy for migraine; bone health, where we recently submitted our bone-building Romosozumab to FDA for regulatory review; nephrology, with the prospect of an imminent launch of Parsabiv; and of course in inflammation, where we were pleased with the recent FDA panel review of our biosimilar to Humira.

繼近期推出六款心血管疾病和癌症藥物之後，我們在其他四個治療領域的項目也即將達到關鍵的監管里程碑：神經病學領域，我們對 Erenumab 有望成為治療偏頭痛的首創療法感到興奮；骨骼健康領域，我們最近已將用於促進骨骼生長的 Romosozumab 提交給 FDA 監管審查專家；腎臟健康領域，我們最近已將用於促進骨骼生長的 Romosozumab 提交給 FDA 監管類似的生物製劑感到滿意。

With an expected 80 new launches across countries and products this year, and the recent re-acquisition of rights to many of our existing products outside the United States, we're meaningfully expanding our global footprint. To that end, we recently announced that we had partnered with Daiichi Sankyo in an effort to bring Amgen biosimilars to the Japanese market.

今年，我們預計將在全球各地推出80款新產品，加上近期重新獲得了美國以外地區眾多現有產品的權益，我們的全球業務版圖正在顯著擴大。為此，我們近期宣布與第一三共株式會社合作，致力於將安進生物相似藥引進日本市場。

I would also note we are excited about the scientific progress we are making in our early research labs. For example, we continue to harness the power of our human genetics platform to uncover fundamental links to human disease.

我還想指出，我們對早期研究實驗室的科學進展感到非常振奮。例如，我們正持續利用人類遺傳學平台的力量，揭示人類疾病的根本關聯。

As you saw this quarter, we published research pointing to the role of the ASGR1 gene in cardiovascular disease. While this is still early stage, it highlights our unique ability to generate insights like this, and to move them forward quickly in the drug development process. We expect insights such as this to be central to our ability to innovate, and continue to deliver long-term growth and returns for our shareholders.

如您在本季所見，我們發布了一項研究，指出ASGR1基因在心血管疾病中發揮重要作用。雖然這項研究仍處於早期階段，但它凸顯了我們獨特的洞察力，能夠產生此類見解，並迅速將其推進藥物研發進程。我們預期此類見解能夠成為我們創新能力的核心，並持續為股東帶來長期成長和回報。

While we're focused on the long term, we're committed to delivering in the short and medium term, as well. Our consistent strong performance has placed us well on our way towards delivering the long-term commitments we made to shareholders for 2018. The transformation program which we began some two years ago continues to deliver savings, enabling us to invest in our business and deliver results for our shareholders.

我們著眼於長遠發展，同時也致力於在中短期內取得佳績。我們持續強勁的業績表現，使我們朝著實現2018年對股東做出的長期承諾穩步邁進。我們兩年前啟動的轉型計畫持續帶來成本節約，使我們能夠投資自身業務，並為股東創造回報。

Similarly, the commitment we made to effectively manage the life cycle of our legacy products is bearing fruit, as reflected in the success of our Neulasta Onpro launch, and the success we're having in offering Aranesp and Epogen to our dialysis customers.

同樣，我們對有效管理傳統產品生命週期的承諾也正在取得成果，這體現在我們成功推出 Neulasta Onpro，以及我們向透析客戶提供 Aranesp 和 Epogen 的成功。

Our balance sheet remains strong, and we're active in looking for ways to build our business across our six therapeutic focus areas. We expect to be patient and disciplined in looking for opportunities that we think we can add value to for our shareholders.

我們的資產負債表依然穩健，我們正積極尋求在六大治療領域拓展業務的途徑。我們將保持耐心和審慎，尋找能為股東創造價值的投資機會。

Before passing to our Chief Financial Officer David Meline, let me just thank our staff worldwide for their ongoing dedication to our mission of serving patients, and for the results they've once more delivered for our shareholders. David?

在將發言權交給財務長大衛梅林之前，請讓我感謝全球員工一直以來對我們服務病患使命的奉獻，以及他們再次為股東創造的佳績。大衛？

Okay, thanks, Bob. Turning to the second-quarter financial results on page 6 of the slide deck, revenues at $5.7 billion grew 6% year over year, with 5% product sales growth driven by continued momentum across much of our product portfolio. Other revenues at $214 million increased $69 million versus the second quarter of 2015. Other revenue benefited from higher Ibrance royalty income, as well as an up-front partner payment. As a reminder, we receive an 8% royalty on Ibrance revenue, which was acquired as part of the Onyx transaction.

好的，謝謝鮑伯。接下來看一下投影片第6頁的第二季財務表現。營收為57億美元，年增6%，其中產品銷售額成長5%，這主要得益於我們大部分產品組合的持續成長動能。其他營收為2.14億美元，較2015年第二季成長6,900萬美元。其他收入的成長得益於Ibrance特許權使用費收入的增加以及一筆預付合作夥伴款項。需要說明的是，我們從Ibrance收入中獲得8%的特許權使用費，該收入是我們在收購Onyx時獲得的。

Changes in foreign exchange had an immaterial impact on total revenue and product sales in the quarter. Non-GAAP operating income at $2.8 billion grew 10% from prior year. Non-GAAP operating margin improved to 51.4% for the quarter, reflecting continued growth and progress from our transformation initiatives across all operating expense categories.

匯率變動對本季總營收和產品銷售額的影響微乎其微。非GAAP營業收入為28億美元，較上年同期成長10%。本季非GAAP營業利潤率提升至51.4%，反映出我們在所有營運費用類別中持續成長，以及轉型措施的進展。

In 2016, we remain on track to deliver over $400 million of incremental gross efficiency savings from the transformation versus prior year, with half of incremental gross efficiency savings from the transformation occurring in the first half. Delivering on this transformation enables continued investment into our pipeline and launch activities, while also achieving solid profitability.

2016年，我們仍有望實現轉型帶來的超過4億美元的額外毛效率提升，其中一半的額外毛​​效率提升將在上半年實現。轉型的成功將使我們能夠繼續投資於產品研發和上市活動，同時實現穩健的獲利能力。

On a non-GAAP basis, cost of sales as a percent of product sales at 13.5% improved by 1.6 points, driven by manufacturing efficiencies and higher net selling price. Research and development expenses at $878 million decreased by 4% versus last year, driven primarily by transformation and process improvement efforts, and lower spending required to support certain later-stage clinical programs.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比為13.5%，較上年下降1.6個百分點，主要得益於生產效率的提高和淨售價的上漲。研發費用為8.78億美元，較前一年下降4%，主要得益於轉型和流程改善工作，以及支持某些後期臨床項目所需支出的減少。

SG&A expenses increased 13% on a year-over-year basis, as increased commercial investments in new product launches for the US and global launch activities were enabled by savings from transformation and process improvement efforts.

由於轉型和流程改善工作帶來的節省，美國新產品上市和全球上市活動的商業投資增加，導致銷售、一般及行政費用年增 13%。

In total, non-GAAP operating expenses increased 2% year over year. Other income and expenses were a net $176 million expense in Q2. This is an increase of $97 million on a year-over-year basis. This year-over-year net expense increase was primarily due to gains in the second quarter of 2015 from our strategic and venture investment portfolio. We expect our other income and expenses to continue at the current year-to-date trend level.

非GAAP營運費用總額較去年同期成長2%。第二季其他收入及支出淨額為1.76億美元，較上年同期增加9,700萬美元。此淨支出年增率主要歸因於2015年第二季策略和創投組合的收益。我們預計其他收入和支出將持續維持年初至今的趨勢水準。

The non-GAAP tax rate was 18.6% for the quarter, a 1.4-point decrease versus Q2 of 2015. This decrease reflects discrete benefits associated with tax incentives, and the adoption of accounting standards update 2016-09, partially offset by unfavorable changes in the geographic mix of earnings. Non-GAAP net income increased 9%, and non-GAAP earnings per share increased 11% year over year.

本季非GAAP稅率為18.6%，較2015年第二季下降1.4個百分點。這一下降反映了稅收優惠帶來的特定收益以及2016-09會計準則更新的實施，但部分被盈利地域構成不利變化所抵消。非GAAP淨利年增9%，非GAAP每股盈餘較去年同期成長11%。

Turning next to cash flow and the balance sheet on page 7. Free cash flow was $2.5 billion for the quarter, compared to free cash flow of $3.2 billion in the second quarter of 2015. This year-over-year decline reflects timing impacts of income tax payments to the IRS, and cash gains realized last year from foreign exchange contracts which benefited from a strengthened US dollar.

接下來請看第7頁的現金流量表和資產負債表。本季自由現金流為25億美元，而2015年第二季為32億美元。同比下降反映了向美國國稅局繳納所得稅的時間影響，以及去年因美元走強而實現的外匯合約現金收益。

We deployed $0.6 billion to re-purchase 3.9 million shares in the quarter, at an average price of $153 per share, and are on track to achieve total share re-purchase for this year in the range of $2 billion to $3 billion. Additionally, our second-quarter dividend was $1 per share, an increase of 27% over last year, which results in a dividend yield of over 2.5% on an annualized basis. At the end of the second quarter, we had $3.6 billion remaining on our Board-authorized share buy-back program.

本季我們投入6億美元回購了390萬股股票，平均回購價格為每股153美元，預計今年股票回購總額將達20億至30億美元。此外，我們第二季派發的股息為每股1美元，較去年同期成長27%，年化股息殖利率超過2.5%。截至第二季末，我們董事會批准的股票回購計畫中仍有36億美元剩餘。

Cash and investments totaled $35 billion, an increase of $5 billion from last year's second-quarter level. This increase reflects continued solid net cash flow, and the first-quarter debt issuance of $2.9 billion, of which approximately $900 million was used to re-pay debt maturities during the second quarter. Our debt balance stands at $33.2 billion as of June 30, 2016. Our total debt portfolio has a weighted average interest relate of 3.6%, and an average maturity of 12 years.

現金及投資總額為350億美元，較去年同期增加50億美元。這一增長反映了公司持續穩健的淨現金流，以及第一季發行的29億美元債券，其中約9億美元用於償還第二季到期的債務。截至2016年6月30日，公司債務餘額為332億美元。公司債務組合的加權平均利率為3.6%，平均期限為12年。

Turning to the outlook for the business for the remainder of 2016 on page 8, we remain on track with our plans to continue investing to grow the business, while transforming to a more agile and efficient operating model. Today we are increasing our 2016 guidance, which reflects continued conviction in executing on our strategy, and solid first-half performance of the business.

關於2016年剩餘時間的業務展望（詳見第8頁），我們將繼續按計畫投資以促進業務成長，同時轉型為更靈活高效的營運模式。今天，我們上調了2016年業績預期，這反映了我們對執行策略的持續信心，以及公司上半年穩健的業績表現。

In particular, our overall revenue guidance reflects our recent product launch activities, plus continued progress on our growth brands, which grew 13% year over year in Q2, and accounted for over 50% of all product sales. All of this is while absorbing the impact of competition on our legacy Epogen and Neupogen brands.

具體而言，我們的整體營收預期反映了近期的新產品上市活動，以及成長型品牌持續取得的進展。這些品牌在第二季年增13%，佔所有產品銷售額的50%以上。同時，我們也在努力應對競爭對我們傳統品牌Epogen和Neupogen帶來的衝擊。

With this background, our 2016 revenue guidance is now $22.5 billion to $22.8 billion, versus prior guidance of $22.2 billion to $22.6 billion. Our non-GAAP earnings-per-share guidance is now $11.10 to $11.40 a share, versus prior guidance of $10.85 to $11.20.

基於此背景，我們目前將2016年營收預期調整為225億美元至228億美元，高於先前預期的222億美元至226億美元。我們目前將非GAAP每股盈餘預期調整為11.10美元至11.40美元，高於先前預期的10.85美元至11.20美元。

Finally, we continue to expect our adjusted tax rate to be in the range of 19% to 20%, and capital expenditures to be approximately $700 million this year. This concludes the financial update. I will now turn the call over to Tony.

最後，我們仍預期調整後的稅率將在19%至20%之間，今年的資本支出約為7億美元。財務更新到此結束。現在我將把電話交給東尼。

Thanks, David. You'll find a summary of our sales performance for the second quarter on slide number 10. We continued our strong performance in the second quarter, with global product sales growing 5% year over year. Our US business delivered 5% year over year growth, and our international business grew 3%, or 5% year over year, excluding the impact of foreign exchange. Europe was a strong contributor, with 11% unit growth.

謝謝，大衛。您可以在第10頁投影片上找到我們第二季的銷售業績摘要。第二季我們延續了強勁的業績表現，全球產品銷售額年增5%。美國業務年增5%，國際業務成長3%，若不計匯率影響，則較去年同期成長5%。歐洲市場貢獻尤為顯著，銷量成長11%。

My comments will be in three parts today. First, the performance of our growth products, followed by an update of our life cycle management with the mature brands, and then I'll conclude with highlights on the performance of our newly launched products.

我今天的發言將分為三個部分。首先，我將介紹我們成長型產品的表現；其次，我會更新成熟品牌的生命週期管理情況；最後，我會重點介紹我們新推出的產品的表現。

Our six growth products, Prolia, Xgeva, Enbrel, Sensipar, Vectibix, and Nplate, continue to drive our overall performance, with 13% year-over-year growth. As David said, they aggregated to $3 billion of sales, well over 50% of second-quarter sales. We continue our investments in these brands to achieve their full potential.

我們的六大成長型產品——Prolia、Xgeva、Enbrel、Sensipar、Vectibix 和 Nplate——持續推動公司整體業績成長，年成長 13%。正如 David 所說，這些產品合計銷售額達 30 億美元，佔第二季總銷售額的 50% 以上。我們將繼續加大對這些品牌的投資，以充分發揮其潛力。

Both Prolia and Xgeva are now annualizing at over $3 billion per year. Prolia grew 30% year over year, with a 24% unit growth, and continued share gains in both the US and Europe.

Prolia和Xgeva的年化收入目前都超過30億美元。 Prolia年增30%，銷售成長24%，並在美國和歐洲市場持續擴大市場佔有率。

Post-menopausal osteoporosis remains a widely undertreated disease. In the US alone, 10 million people are affected, and 4.5 million of those are considered at high risk of fracture. Unfortunately, nearly 60% of these patients are not treated. We are investing in Prolia to reach these unserved patients and also to remind current Prolia patients about the important of returning every six months for their treatment.

停經後骨質疏鬆症仍然是一種治療不足的疾病。光在美國，就有1000萬人受到影響，其中450萬人被認為骨折風險較高。不幸的是，近60%的患者沒有接受治療。我們正在投資Prolia項目，旨在幫助這些未經治療的患者，並提醒Prolia的現有患者每六個月按時復診接受治療的重要性。

Xgeva saw a 15% year-over-year growth, driven by unit-share gains of around two percentage points in both the US and Europe. Quarter-over-quarter growth was negatively impacted by heavier purchasing from some larger end customers in the US during the first quarter.

Xgeva年增15%，主要得益於美國和歐洲市佔率均成長約兩個百分點。由於第一季美國部分大型終端客戶的採購量增加，環比成長受到一定影響。

Enbrel grew 10% year over year, driven by changes in net selling price, partially offset by competition. As a reminder, changes in net selling price comprised several components, including changes in list price, as well as the impact from rebates we provide to payers, and formulary decisions.

恩利（Enbrel）的銷售額年增10%，主要得益於淨售價的變化，但部分被市場競爭所抵銷。需要說明的是，淨售價的變化包含多個組成部分，包括標價的變化、我們向支付方提供的回扣以及藥品目錄調整的影響。

Turning now to the underlying performance of Enbrel, growth within both rheumatology and dermatology segments continues. Sequentially, Enbrel lost two points of value share in each segment. Recall that rheumatology comprises about 80% of Enbrel sales. Enbrel has a long track record of safety, efficacy, and a very competitive profile. We are focused on maintaining our position, particularly in the rheumatology segment.

現在來看看恩利（Enbrel）的實際業績，其在風濕病和皮膚病領域的成長勢頭依然強勁。環比來看，恩利在這兩個領域的市佔率均下降了兩個百分點。需要指出的是，風濕病領域約佔恩利銷售額的80%。恩利擁有長期良好的安全性、有效性和極具競爭力的市場地位。我們將致力於維持市場地位，尤其是在風濕病領域。

Sensipar grew 13% year over year, driven by net selling price, as well as a strong unit growth in the US and Europe. We look forward to expanding our presence in the nephrology market with Parsabiv, which is currently being reviewed by the US and European regulators as a new treatment option for secondary hyperparathyroidism.

受淨售價上漲以及美國和歐洲市場強勁的銷售成長推動，Sensipar較去年同期成長13%。我們期待透過Parsabiv擴大在腎臟病市場的份額。 Parsabiv目前正在接受美國和歐洲監管機構的審查，並有望成為繼發性副甲狀腺功能亢進的新治療方案。

Next, Vectibix. We delivered strong unit growth in our core markets; however this performance was masked by comparing against a second quarter in 2015 that benefited from an additional shipment to our Japanese partner.

接下來是Vectibix。我們在核心市場實現了強勁的銷售成長；然而，由於與2015年第二季相比，這一業績被掩蓋了，因為2015年第二季受益於向日本合作夥伴的額外出貨。

Nplate grew 14% year over year, driven by double-digit unit growth.

Nplate年增14%，主要得益於兩位數的銷售成長。

I would now like to focus on how we are managing the life cycle around mature brands. Neulasta sales decreased 1% year over year. The second quarter was negatively impacted by heavier purchasing by some large end customers in the US in the first quarter.

現在我想重點談談我們如何管理成熟品牌的生命週期。 Neulasta 的銷售額較去年同期下降了 1%。第二季受到美國一些大型終端客戶在第一季大量採購的影響。

I am pleased to report that the Neulasta Onpro delivery kit continues its strong up-take. Adoption is growing due to its ability to ensure maximum benefit of Neulasta, while improving the patient experience versus the traditional pre-filled syringe. We exited the second quarter with Onpro representing about 40% of Neulasta units, and still growing. We do not expect long-acting pegfilgrastim biosimilar competition this year, so there remains a significant opportunity to further increase the adoption of Onpro.

我很高興地報告，Neulasta Onpro給藥套裝的銷售持續強勁成長。其應用日益廣泛，原因在於它能夠確保Neulasta發揮最大療效，同時相比傳統的預充式註射器，顯著改善患者體驗。第二季末，Onpro的銷量約佔Neulasta總銷量的40%，且仍在持續成長。我們預計今年不會出現長效培非格司亭生物相似藥的競爭，因此Onpro的銷售量仍有很大的提升空間。

As regards Neupogen, we see the short-acting segment playing out as expected. We ended the second quarter with around 60% share. We continued to compete account by account, emphasizing Neupogen's sustained track record of safety, efficacy, and of course reliable supply.

關於紐普根（Neupogen），我們看到短效製劑市場的發展符合預期。第二季末，我們的市佔率約為60%。我們繼續逐個客戶地展開競爭，強調紐普根在安全性、有效性和穩定供應方面的持續良好記錄。

Now to ESAs. Aranesp's sales increased 5% year over year, driven by 13% unit growth. In the US, we've been successfully transitioning about 75% of patients from Epogen to Aranesp in our medium-size and independent dialysis centers.

接下來談談促紅血球生成素（ESA）。 Aranesp 的銷售額年增 5%，主要得益於銷量成長 13%。在美國，我們已成功地將中型和獨立透析中心約 75% 的患者從 Epogen 過渡到 Aranesp。

Epogen declined 33% year on year. About 1/3 of this decline is the shift from Epogen to Aranesp in the dialysis setting I just mentioned. Most of the remaining decline is due to a shift by Fresenius from Amgen ESAs to their own product. We understand that Fresenius, which has about 1/3 of the US business, has converted about 80% of their patients. You'll recall that our contract with DaVita, who represent another 1/3 of the dialysis business, runs through 2018. We do not expect biosimilar competition against Epogen in 2016.

Epogen 的銷量年減了 33%。其中約三分之一的降幅是由於我剛才提到的透析患者從使用 Epogen 轉而使用 Aranesp。剩餘的大部分降幅則歸因於 Fresenius 公司將 Amgen 的促紅血球生成素 (ESA) 產品轉而使用其自有產品。據我們了解，Fresenius 公司佔據了美國市場約三分之一的份額，目前已成功完成了約 80% 患者的轉換。您可能還記得，我們​​與 DaVita 公司（該公司佔據了透析市場另外三分之一的份額）的合約有效期至 2018 年。我們預期 2016 年 Epogen 不會面臨生物相似藥的競爭。

Lastly, I would like to update you on Repatha and Kyprolis. Both products represent substantial opportunities in addressing serious diseases with significant un-met needs.

最後，我想向大家介紹一下Repatha和Kyprolis的狀況。這兩種產品在解決一些存在重大未滿足醫療需求的嚴重疾病方面都具有巨大的潛力。

First, Repatha. Our cardiovascular teams have executed well in the marketplace, with strict utilization management criteria, and processes employed by the insurers and PBMs continues to be the biggest hurdle. We're working diligently to address these restrictions so the appropriate patients are able to access the treatment their doctors prescribe for them.

首先是瑞百安（Repatha）。我們的心血管團隊在市場上表現出色，嚴格執行了用藥管理標準，但保險公司和藥品福利管理機構（PBM）的流程仍然是最大的障礙。我們正在努力克服這些限制，確保合適的患者能夠獲得醫生為其製定的治療方案。

We look forward to the coronary imaging data from the GLAGOV study reading out later this year, and then the FOURIER outcomes data in the first quarter of 2017. We expect that both these studies will further underscore the value of Repatha.

我們期待今年稍後公佈 GLAGOV 研究的冠狀動脈成像數據，以及 2017 年第一季公佈的 FOURIER 研究結果數據。我們預期這兩項研究將進一步凸顯 Repatha 的價值。

We are also excited to now offer a new monthly dosing treatment option with our recently improved Repatha Pushtronex, the first and only single monthly injection of a PCSK9 inhibitor. Like the Neulasta Onpro delivery kit, this is another example of our ability to identify and develop innovative delivery systems to improve the patient experience.

我們很高興地宣布，我們近期改良的Repatha Pushtronex現已推出全新的每月一次給藥治療方案，這是目前首個也是迄今為止唯一一個每月一次注射的PCSK9抑制劑。與Neulasta Onpro給藥套件一樣，這再次體現了我們識別和開發創新給藥系統以改善患者體驗的能力。

Outside the US, we continue to make good progress with Repatha's reimbursement negotiations on a country-by-country basis. In Europe, we are now in early launches in several countries, including Germany, Netherlands, Spain, the UK, Austria, and Sweden. Repatha is an extremely important medicine for high-risk cardiovascular patients, and we are committed to realizing its significant potential over time.

在美國以外，我們與各國就瑞百安（Repatha）的健保報銷談判持續取得良好進展。在歐洲，我們已在包括德國、荷蘭、西班牙、英國、奧地利和瑞典在內的多個國家啟動了瑞百安的早期上市。瑞百安對於高風險心血管疾病患者而言是一種極為重要的藥物，我們致力於隨著時間的推移，充分發揮其巨大的市場潛力。

Now to Kyprolis, where we have made great progress in the quarter. We continue to grow volume in an intensely competitive environment with three new competitors, all approved in the US late last year. This growth is encouraging, as we continue to educate the physicians on the benefits of Kyprolis as a backbone of multiple myeloma therapy. Our focus is on continuing to drive adoption of Kyprolis in relapsed patients, based on the compelling ASPIRE and ENDEAVOR data.

現在來談談Kyprolis，我們在本季取得了顯著進展。儘管面臨三家新競爭對手（它們均於去年底在美國獲準），我們在競爭異常激烈的市場環境中依然保持著銷售成長。這一增長令人鼓舞，因為我們將繼續向醫生普及Kyprolis作為多發性骨髓瘤核心療法的優勢。基於ASPIRE和ENDEAVOR研究的強大數據，我們的重點是繼續推動Kyprolis在復發患者中的應用。

The early launches from our European organization into second line are very encouraging. Kyprolis has been well received, and we continue to gain reimbursement approval country by country. The EU label now includes Kyprolis in both a three-drug regimen, based on the ASPIRE data, as well as a two-drug regimen based on the ENDEAVOR data.

我們歐洲機構早期在二線治療領域的成果令人鼓舞。 Kyprolis 獲得了良好的市場反響，我們正持續在各國獲得健保報銷批准。目前，歐盟藥品標籤已將 Kyprolis 納入基於 ASPIRE 研究數據的三藥聯合治療方案以及基於 ENDEAVOR 研究數據的雙藥聯合治療方案。

In summary, the second quarter was another strong quarter for Amgen. Our growth products led the way, while we defended our mature products. We've made good progress on bringing new launch products to more patients in both existing and new countries. We remain convinced about the long-term growth potential of our launch brands, and are working intensely to ensure their success.

總而言之，安進第二季業績依然強勁。成長型產品表現突出，成熟產品也維持了良好的市場地位。我們在將新產品推向現有市場和新市場的患者群體方面取得了顯著進展。我們對現有上市品牌的長期成長潛力充滿信心，並正全力以赴確保其成功。

Let me close by recognizing that none of this would have been possible without the dedication of our staff, and thanking them for their commitment to delivering for patients. Let me now pass you to Sean.

最後，我要感謝所有員工的奉獻，正是他們的辛勤付出才使得這一切成為可能。感謝他們為患者提供優質服務。現在，請肖恩發言。

Thanks, Tony. Good afternoon. We continued to make good progress advancing our pipeline in both innovative and biosimilar molecules. Let me begin with cardiovascular. We don't believe there is any compelling evidence that supports treating high-risk ASCVD patients with anything but aggressive LDL cholesterol-lowering therapy. Our approach with Repatha differs from that taken by the other marketed PCSK9 inhibitor, in that we only maximally inhibit PCSK9 and LDL cholesterol.

謝謝，托尼。午安.我們在創新藥物和生物相似藥的研發管線方面持續取得良好進展。首先談談心血管方面。我們認為，目前尚無充分證據支持對高風險動脈粥狀硬化性心血管疾病（ASCVD）患者採用除積極降低低密度脂蛋白膽固醇（LDL-C）治療以外的其他療法。我們研發的瑞百安（Repatha）與其他已上市的PCSK9抑制劑不同，我們僅最大限度地抑制PCSK9和LDL-C。

Our clinical program demonstrated that we could achieve this effect with either 140 milligrams of Repatha delivered every other week, or 420 milligrams delivered monthly. As is reflected in our label, these two dosing schedules were clinically equivalent. Now that we have received approval in the United States for the innovative Pushtronex delivery system, we can offer patients the choice of an auto-injector pen for every other week, or single monthly dose administration with Pushtronex.

我們的臨床計畫表明，無論是每隔一週注射140毫克Repatha，或是每月注射420毫克，都能達到預期的療效。正如我們的藥品說明書所述，這兩種給藥方案在臨床上是等效的。現在，我們已獲得美國對創新Pushtronex給藥系統的批准，可以為患者提供兩種選擇：每隔一周使用自動注射筆給藥，或每月一次使用Pushtronex給藥。

As we announced last month, we expect the results from our Phase III cardiovascular outcome study to be available in 1Q of 2017, in time for submission to the American College of Cardiology meeting in March. I would remind you this is an event-driven study, and at the time we had accrued in excess of 85% of the requisite events, which allowed us to more accurately predict the timing for the study completion.

正如我們上個月宣布的那樣，我們預計III期心血管結局研究的結果將於2017年第一季公佈，以便及時提交給3月舉行的美國心臟病學會年會。我想提醒各位，這是一項事件驅動型研究，當時我們已經收集到超過85%的必要事件，這使我們能夠更準確地預測研究完成時間。

This is a large study of 27,500 patients, and we remain focused on generating the most robust data set possible in this field from an analysis of the completed study. Ahead of this, we also expect the coronary imaging study results later this year, which we expect to complement the cardiovascular outcomes data.

這是一項納入27,500名患者的大型研究，我們將繼續致力於透過已完成研究的分析，以產生該領域最可靠的數據集。在此之前，我們也預計今年稍後將獲得冠狀動脈影像學研究結果，我們期望這些結果能補充心血管結局數據。

In heart failure, after discussions with regulators on Omecamtiv mecarbil, our novel cardiac myosin activator from Cytokinetics, we have submitted our heart failure outcome study protocol for special protocol assessment, or SPA, to FDA, and continue to work with our partners toward advancing this novel therapy.

在心臟衰竭領域，我們與監管機構就 Cytokinetics 公司研發的新型心臟肌球蛋白激活劑 Omecamtiv mecarbil 進行了討論後，已向 FDA 提交了心臟衰竭結果研究方案，以進行特殊方案評估 (SPA)，並繼續與我們的合作夥伴共同推進這項新療法。

Turning to oncology, we were pleased to receive European approval for Kyprolis in combination with dexamethasone in the relapsed refractory multiple myeloma setting, based on the ENDEAVOR data. In the first-line setting, we are conducting CLARION, an approximately 900-patient head-to-head superiority study of Kyprolis versus Velcade, both administered concomitant with melphalan and prednisone in transplant-ineligible subjects with newly diagnosed multiple myeloma. This has a primary end-point of progression-free survival. Based on the current event rates, we now expect the primary analysis and top-line results of the completed study in the second half of this year.

在腫瘤治療方面，我們很高興地宣布，基於 ENDEAVOR 研究數據，Kyprolis 聯合地塞米松用於治療復發難治性多發性骨髓瘤已獲得歐洲批准。在第一線治療方面，我們正在進行 CLARION 研究，這是一項納入約 900 名患者的頭對頭優效性研究，旨在比較 Kyprolis 與 Velcade 聯合美法崙和潑尼松治療新診斷的多發性骨髓瘤患者（不適合移植）的療效。研究的主要終點是無惡化存活期。根據目前的事件發生率，我們預計今年下半年公佈該研究的主要分析結果和初步結果。

Before I leave multiple myeloma, I would like to remind you that we remain on track to complete our Phase III study of Xgeva versus zolendronic acid in the prevention of skeletal-related events.

在我離開多發性骨髓瘤之前，我想提醒大家，我們仍在按計劃完成 Xgeva 與唑來膦酸在預防骨骼相關事件方面的 III 期研究。

In the quarter, we announced that FDA had granted priority review status to Blincyto for the treatment of pediatric Philadelphia chromosome-negative relapsed refractory ALL, with a PDUFA action date of September.

本季度，我們宣布 FDA 已授予 Blincyto 優先審查資格，用於治療兒童費城染色體陰性復發難治性 ALL，PDUFA 行動日期為 9 月。

In the adult population, we had the opportunity last month at ASCO to present the results of our confirmatory Phase III study of Blincyto. In this study, Blincyto demonstrated an almost two-fold increase in median overall survival compared to the standard of care. We will be discussing these data with regulators as we seek conversion to full approval in our current indication.

上個月，我們有機會在ASCO會議上公佈了Blincyto在成人人群中的III期確證性研究結果。該研究表明，與標準療法相比，Blincyto使中位總存活期延長了近兩倍。我們將與監管機構討論這些數據，以期獲得目前適應症的全面批准。

As we announced last week, along with our partners at UCB, we have submitted our romosozumab BLA to FDA for the treatment of osteoporosis in post-menopausal women at increased risk for fracture. We'll be presenting the data from the pivotal Phase III frame study at the annual meeting of the American Society of Bone and Mineral Research in September, and we look forward to sharing the results with the medical community.

正如我們上週宣布的那樣，我們已與合作夥伴 UCB 向 FDA 提交了 romosozumab 的生物製品許可申請 (BLA)，用於治療停經後骨折風險增加的女性骨質疏鬆症。我們將於 9 月在美國骨與礦物質研究學會年會上公佈關鍵性 III 期框架研究的數據，並期待與醫學界分享研究結果。

Recall we are also running a Phase III fracture study of romosozumab compared to alendronate, which will contribute to our submission in Europe, and we expect these data in 2017.

請記住，我們也正在進行一項 romosozumab 與阿崙膦酸鈉相比的 III 期骨折研究，這將有助於我們向歐洲提交申請，我們預計這些數據將在 2017 年公佈。

For Prolia, later this year we will be reviewing the data from our Phase III study in the setting of glucocorticoid-induced osteoporosis, a relatively small but medically important indication.

對於 Prolia，我們將在今年稍後審查我們在糖皮質激素引起的骨質疏鬆症背景下的 III 期研究數據，這是一個相對較小但具有重要醫學意義的適應症。

Our neuroscience programs continue to advance. In our migraine collaboration with Novartis, we were pleased to receive positive results from erenumab, or AMG 334, our CGRP receptor antibody, and our Phase II-b chronic migraine study. These data will be presented at the European Headache and Migraine Trust International Congress in September.

我們的神經科學計畫持續取得進展。在與諾華公司合作進行的偏頭痛研究中，我們很高興地收到erenumab（商品名AMG 334，一種CGRP受體抗體）在IIb期慢性偏頭痛研究中取得的正面結果。這些數據將於9月在歐洲頭痛和偏頭痛信託國際大會上發表。

This was a large, robust study, and we believe these data, together with our two Phase III studies in episodic migraine reading out later this year, could support registration in some jurisdictions, so we intend to seek both indications in our initial submission.

這是一項規模龐大、嚴謹的研究，我們相信這些數據，加上我們今年稍後公佈的兩項關於發作性偏頭痛的 III 期研究結果，可以支持在某些司法管轄區進行註冊，因此我們打算在首次提交的申請中尋求這兩種適應症的批准。

Our other clinical migraine program is our PAC-1 antibody, AMG 301, which is currently proceeding nicely through Phase I development. PAC-1 is a receptor for PACAP, a neuropeptide implicated in migraine. We believe that AMG 301 has the potential to be additive or synergistic to erenumab, given that PAC-1 is mechanistically differentiated from CGRP, and we are therefore pursuing the concept of a bi-specific PAC-1 CGRP receptor antibody, as well.

我們另一項針對偏頭痛的臨床項目是PAC-1抗體AMG 301，目前正順利進行I期臨床試驗。 PAC-1是PACAP（一種與偏頭痛相關的神經肽）的受體。鑑於PAC-1與CGRP在作用機制上有差異，我們認為AMG 301有可能與erenumab產生疊加或協同作用，我們也積極探索開發雙特異性PAC-1/CGRP受體抗體的概念。

In our nephrology franchise, we continue to work with regulators on our Parsabiv applications, and look forward to our PDUFA data in the US next month. Parsabiv provides an opportunity to offer a novel intravenous calcimemetic option that's administered by health care providers three times a week, coincident with the patient's dialysis session. Parsabiv would be the first therapy approved for the treatment of secondary hypoparathyroidism in over a decade.

在我們的腎臟病業務領域，我們正持續與監管機構合作推進Parsabiv的申請，並期待下個月在美國獲得PDUFA數據。 Parsabiv提供了一種新型的靜脈注射鈣敏感受體激動劑治療方案，由醫護人員每週三次在患者透析期間進行給藥。 Parsabiv有望成為十多年來首個獲準用於治療繼發性副甲狀腺功能低下症的療法。

Finally, within our biosimilars program, last week we announced results from our Phase III study evaluating the efficacy and safety of ABP 980 compared to trastuzumab or Herceptin in patients with HER2-positive early breast cancer. Based on the overall bioanalytics, efficacy, safety, and immunogenicity, we believe there are no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to discussing these data with regulators.

最後，在我們的生物相似藥計畫中，上週我們公佈了評估ABP 980與曲妥珠單抗或赫賽汀在HER2陽性早期乳癌患者中療效和安全性的III期研究結果。基於整體生物分析、療效、安全性和免疫原性，我們認為ABP 980與曲妥珠單抗之間沒有臨床意義上的差異，我們期待與監管機構討論這些數據。

As always, I'd like to thank my Amgen colleagues for their continued advancement of important new medicines for patients around the world. Bob?

一如既往，我要感謝安進公司的同事們，感謝他們持續推動重要新藥的研發，造福世界各地的病人。鮑伯？

Okay, thank you, Sean. As you can see, it's another active quarter here at the Company; but hopefully you'll agree another quarter of solid execution, as we make progress towards our short, medium, and long-term goals of delivering growth for shareholders. With that, why don't we turn it over to a question-and-answer session. Perhaps we could ask our operator to remind you of the procedure for asking questions.

好的，謝謝肖恩。如您所見，公司本季又是一個繁忙的季度；但希望您也認同，我們本季執行穩健，正朝著為股東創造成長的短期、中期和長期目標穩步邁進。接下來，我們進入問答環節。或許我們可以請接線生提醒您提問流程。

Absolutely.

絕對地。

(Operator Instructions)

（操作說明）

Your first question comes from the line of Terence Flynn with Goldman Sachs.

你的第一個問題源自於特倫斯·弗林在高盛集團的經歷。

Hi, thanks for taking the questions. Maybe two for me. First on the COGS, pretty impressive versus a year ago. Just wondering if that level's sustainable longer-term. Then on Repatha, Sean, can you remind us what you want to see out of the IVUS trial, and if there's any potential read-through to the outcomes data coming next year? Thank you?

您好，感謝您回答問題。我有兩個問題。首先是關於COGS（成本），與一年前相比，這個數字相當可觀。我想知道這個水準能否長期維持。其次是關於Repatha（瑞百安），Sean，您能否提醒我們您希望從IVUS（血管內超音波）試驗中看到什麼結果，以及明年公佈的臨床結果數據是否有任何參考價值？謝謝！

Okay, Terence, we will try and take those in two parts. I will ask David to speak first about the question about COGS; and then Sean can talk about Repatha.

好的，特倫斯，我們分成兩部分來討論。我先請大衛談談關於COGS的問題；然後肖恩可以談談Repatha。

Big picture, as you know, we've been working towards improving the efficiency and productivity of our manufacturing organization for some time. You have heard us say before, Terence, we think manufacturing is a source of competitive advantage for Amgen, and we're excited about what we've achieved to date, and where we're going next with the introduction of our next-generation bio-manufacturing. Generally, the trend is positive. You see that reflected in the quarter. David, do you want to provide any more specific guidance on that?

如您所知，從宏觀層面來看，我們一直在努力提升製造部門的效率和生產力。特倫斯，您之前也聽我們說過，我們認為製造是安進的競爭優勢來源，我們對迄今為止的成就感到興奮，也對即將推出的下一代生物製造技術充滿期待。總體而言，趨勢是正面的，這一點在本季的業績中也有所體現。大衛，您能否就此提供更具體的指導？

No, very much the same, Bob. What we're seeing is we, as you would know, we consolidated our manufacturing activity to try to improve the efficiency. You're now seeing that coming through into the results. I would say through time we'll seek to maintain our cost of sales at that very competitive level, recognizing there will be some pressure on us in terms of the cost of sales as we introduce the new portfolio. But we think it's a reasonable trajectory overall.

不，情況基本上相同，鮑伯。如您所知，我們整合了生產活動，以提高效率。現在您也看到了這些努力在業績上的成效。我認為，隨著時間的推移，我們將努力將銷售成本維持在極具競爭力的水平，當然，我們也意識到，隨著新產品組合的推出，銷售成本方面會面臨一些壓力。但我們認為，總體而言，這是一個合理的成長軌跡。

Terence, I think with regard to the IVUS study and the outcomes, the way to think about this is what we're pursuing here in both studies is the hypothesis that, as we continue to lower LDL, the relationship between LDL and outcomes will be maintained that we have observed with statin therapy over the last 20 years.

Terence，我認為關於 IVUS 研究和結果，思考這個問題的方式是，我們在兩項研究中追求的假設是，隨著我們繼續降低 LDL，LDL 與結果之間的關係將保持不變，就像我們在過去 20 年中觀察到的他汀類藥物治療一樣。

Within the IVUS dimension, there has been a clear relationship between the lowering of LDL and the volume of plaque. That linear relationship looks remarkably similar to the one that you see when you look at outcomes versus LDL. There is a known relationship between that IVUS-type effect and outcome.

在血管內超音波（IVUS）維度上，低密度脂蛋白膽固醇（LDL）降低與斑塊體積之間有明顯的關聯。這種線性關係與觀察預後與LDL之間的關係非常相似。已知IVUS效應與預後之間存在關聯。

It all does tie together. I think that we would be expecting to see conceptually, we believe that the benefits that are observed, both with respect to impact on slowing the progression of plaque volume, or causing regression of plaque volume, as well as in the outcomes dimension, that these are all mediated in the case of statins by the lowering of LDL cholesterol. We expect that pound for pound, if you will, with the LDL cholesterol lowering, we will see very similar sort results.

這一切都是相互關聯的。我認為，從概念上講，我們預期會看到，無論是在減緩斑塊體積進展或促進斑塊體積消退方面，還是在療效方面，他汀類藥物的這些益處都是透過降低低密度脂蛋白膽固醇（LDL-C）水平來實現的。我們預期，如果降低LDL-C水平，就能獲得非常相似的療效。

I think those are the hypotheses we are testing with the two studies.

我認為這些就是我們透過這兩項研究來檢驗的假設。

Your next question comes from the line of Eric Schmidt with Cowen and Company.

你的下一個問題來自 Cowen and Company 的 Eric Sc​​hmidt。

Congrats on a really solid quarter. Maybe a couple quick ones for Tony. Could you talk about the impact that Darzalex is having on Kyprolis? It does look like from the monthly IMS data that we get that there's been a little competitive impact there. Second, I was surprised to see that Amgen's branching out into the ultra-orphan space, at least with an eculizumab biosimilar. Can you talk about how that program might fit commercially with your current capabilities?

恭喜貴公司本季業績非常出色。 Tony，我想問你幾個問題。可以談談Darzalex對Kyprolis的影響嗎？從我們每個月收到的IMS數據來看，Darzalex似乎對Kyprolis的競爭格局產生了一定的影響。其次，我驚訝地發現安進公司正在進軍超罕見疾病領域，至少推出了依庫珠單抗生物相似藥。你能談談這個計畫在商業上如何與貴公司目前的實力相契合嗎？

Okay, thanks Eric. As you know, the data inside the multiple myeloma market is a bit more complicated to try and segment between first, second, and third-line plus. We often have to use chart audits for that. But based on the data we've seen, I mean, clearly a good product; but we truly see the combination potentially of this product and Kyprolis as a future regimen in treating multiple myeloma. Most of the usage we've seen with Darzalex at the moment is fourth-line-plus, however.

好的，謝謝艾瑞克。如您所知，多發性骨髓瘤市場的數據比較複雜，很難區分第一線、二線和三線以上治療方案。我們通常需要查閱病歷才能進行區分。但根據我們目前掌握的數據，這顯然是一款不錯的產品；我們認為該產品與卡普利（Kyprolis）聯合使用，未來有望成為治療多發性骨髓瘤的新方案。不過，目前我們看到的達雷妥尤單抗（Darzalex）的使用主要集中在四線及以上治療。

Your question on our new biosimilar opportunity, I think Amgen has specialized for many years in specialty drugs with a focused target population, with low resources required to get to prescribers, and to identify patients. I think that one fits quite well with our model.

關於您提出的關於我們新的生物相似藥機會的問題，我認為安進多年來一直專注於針對特定目標人群的專科藥物，這些藥物需要較少的資源即可觸達處方醫生並識別患者。我認為這與我們的模式非常契合。

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

你的下一個問題來自摩根士丹利的馬修·哈里森。

Great, thanks for taking the question. If I could ask, maybe if you could comment broadly on biosimilars, you've got three that are at regulatory submission or in regulatory submission. Could you walk through what your thoughts are around when you might be able to launch those products, some of the remaining legal hurdles that you're going to have to get through, and how you see that revenue stream developing over the next year or two? Thanks.

太好了，謝謝您回答這個問題。如果可以的話，我想請您對生物相似藥發表一下看法。您目前有三款生物相似藥正在或已經提交監管審批。您能否談談您預計這些產品何時能夠上市，以及您還需要克服哪些法律障礙，並展望一下未來一兩年內這些產品的收入成長？謝謝。

Well, Matthew, a couple things. First, as you know, we have some nine programs that are under development. Over time, we think those can be an important source of growth and a revenue opportunity for us at Amgen. We think that our commitment to developing these biosimilars reflects our belief the capabilities we have established for our innovative business will lend themselves well to developing a branded biosimilar portfolio, as well.

馬修，有幾件事要跟你說。首先，正如你所知，我們目前有九個專案正在研發中。我們認為，隨著時間的推移，這些項目將成為安進重要的成長點和收入來源。我們致力於研發這些生物相似藥，也反映了我們相信，我們為創新業務所建立的能力同樣適用於開髮品牌生物相似藥產品組合。

The next step for us on the three that are in the advanced regulatory stages, the same path for each of the three, it starts with needing to get a regulatory approval. We hope and expect that we will have an opportunity to get a regulatory approval for our first, which is the biosimilar to Humira, at the end of our -- later this year. With the benefit of that, then with that approval in hand, we'll turn to the questions of commercialization, as we will for the other two. The first thing we need to do is get approvals, and that is what we're working on securing right now.

對於我們目前處於監管審批後期階段的三款產品，下一步的流程相同，都是從獲得監管部門的批准開始。我們希望並預計，今年晚些時候，我們的第一款產品——阿達木單抗（Humira）的生物相似藥——能夠獲得監管部門的批准。一旦獲得批准，我們就可以著手考慮商業化問題，就像其他兩款產品一樣。我們首先需要做的就是獲得批准，而這正是我們目前正在努力的方向。

As to your question about revenue profile and what we are going to do with approvals in hand, we'll wait and comment on those issues at the appropriate time, Matthew.

至於你提出的關於收入狀況以及我們如何處理已獲批准的問題，我們會等待合適的時機再對這些問題發表評論，馬修。

Your next question comes from the line of Geoff Meacham with Barclays.

你的下一個問題來自巴克萊銀行的傑夫‧米查姆。

Afternoon, guys. Thanks for taking the question. Sean, I have a couple for you on erenumab. First one for the chronic migraine data last month, how would you view the baseline migraine data relative to, just put that in context of the real world? The second point is as we look forward to the episodic data, obviously a more variable population, maybe help us with how you would characterize a result as being clinically meaningful in this population? Thanks.

下午好，各位。感謝你們回答問題。肖恩，我有兩個關於依瑞奈單抗的問題想請教你。第一個問題是關於上個月公佈的慢性偏頭痛數據，你如何看待基線偏頭痛數據，並將其置於真實世界的背景下進行分析？第二個問題是，我們即將迎來發作性偏頭痛的數據，顯然，發作性偏頭痛患者的人群差異更大，你能否幫我們分析一下，在這個人群中，如何判斷結果是否具有臨床意義？謝謝。

Sure. I think when we look at the data from the chronic migraine study, it appears to us as though we have enrolled there a very representative population of this type of afflicted group. As you know, these people are suffering with just an unimaginable number of these headaches per month. As we talk to the experts in the field, it seems that the population that we enrolled there in terms of the baseline level of headache, and the kind of response that we saw in comparison to other product candidates in this axis are all as we might have expected.

當然。我認為，當我們查看慢性偏頭痛研究的數據時，我們發現我們招募的受試者群體非常具有代表性，能夠反映這類患者群體的特徵。如你所知，這些人每個月遭受的頭痛次數簡直難以想像。我們與該領域的專家交流後發現，就基線頭痛程度以及我們觀察到的與其他同類候選產品相比的療效而言，我們招募的受試者群體都符合預期。

In the episodic migraine setting, of course, the baseline number of headache days are by definition less; but the treatment effect is still quite robust and reproducible. I think that's been the case. It's within the world of neuroscience products, quite remarkable when you look at the data across the small molecules that have been entered into this space -- the ligand-sequestering antibodies and erenumab, that you see a remarkably consistent treatment effect.

當然，在發作性偏頭痛的背景下，頭痛天數自然較少；但治療效果仍然相當顯著且可重複。我認為情況確實如此。在神經科學產品領域，當你查看已進入該領域的小分子藥物的數據時，你會發現它們——例如配體螯合抗體和依瑞奈單抗——都表現出非常一致的治療效果，這尤其令人矚目。

One comment I would make is that it's the case that this treatment effect is robust, it's reproducable; but there also is quite a large placebo effect that patients get that comes along with the treatment effect. It's durable over a long period of time. This is actually what the patient experiences, which is -- it's not unique to neuroscience, but it's particularly potent in this setting. A little hard to get your mind around that some times, but this is what people who actually care for these patients emphasize to us when we look at the data.

我想補充一點，這種治療效果確實很穩定，可以重複驗證；但患者也會同時感受到相當大的安慰劑效應，而且這種效應會持續很久。這其實就是患者的感受──雖然這種現象並非神經科學領域獨有，但在這個領域尤其顯著。有時候可能有點難以理解，但當我們分析數據時，那些真正照顧這些病人的醫護人員總是強調這一點。

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

你的下一個問題來自瑞士信貸的 Alethia Young。

Hi, guys. Thanks for taking my question, congrats on the quarter. One, can you give us a little bit more color on the timing around biosimilar eculizumab data for the study in New Zealand. Then also on a second point, can you just frame for us how you think about some of the competitors in the migraine space, and how your drug may stack up, or is it a matter of differentiation, or is it just a commercial battle in your mind?

大家好。感謝你們回答我的問題，也恭喜你們本季業績優異。首先，能否詳細介紹一下紐西蘭研究中生物相似藥依庫珠單抗的數據公佈時間安排？其次，能否談談你們如何看待偏頭痛領域的競爭對手，以及你們的藥物在這些競爭對手中處於什麼位置？是產品差異化，還是只是一場商業競爭？

Okay, a couple different questions there. Why don't we -- let's start with the migraine question. Sean, do you want to talk about the field?

好的，這裡有幾個不同的問題。不如我們——先從偏頭痛的問題開始。肖恩，你想談談這個領域嗎？

What I would say again, and I just made this comment, that when you look at what's gone on, where mainly companies have been driving for proof of concept and/or dose ranging their products, they've used doses or either small molecules like anti-sequestering antibodies or receptor antibodies, in our case, that are saturating the system. When that happens, that's how across all these different studies across different companies and so on you're seeing a very consistent result, because you're maxing out the impact that inhibiting CGRP can have in migraines. That's nice to see.

我想再次強調，我剛才也提到過，縱觀目前的情況，各公司主要都在致力於驗證產品概念和/或進行劑量範圍測試，他們使用的劑量，或者像我們研究中使用的抗螯合抗體或受體抗體這樣的小分子藥物，都達到了系統飽和狀態。正因如此，不同公司所進行的各項研究才能得出非常一致的結果，因為這樣已經最大限度地發揮了抑制CGRP治療偏頭痛的療效。這令人欣慰。

Then really it comes down to the question of what is the minimal dose that is effective in achieving that effect. I think then the devil gets into the details really around the issue of how easily administratable is that particular amount of antibodies. There's going to be a certain milligram amount of an antibody that has to be administered. Let's say we believe a monthly subcutaneous disposable auto-injector would be a very nice solution to this otherwise healthy, active type of population.

那麼，問題的關鍵就在於達到該效果所需的最小有效劑量是多少。我認為，接下來的問題涉及如何方便地使用特定劑量的抗體。抗體的注射劑量必須達到一定的毫克級。假設我們認為，對於健康活躍的人群來說，每月一次的皮下注射一次性自動注射器是一個非常理想的解決方案。

I think others of course are pursuing strategies that are different than that. I think it will be interesting, obviously, to see how that all plays out. Tony, you could comment, but I think scientifically I have not seen any data to suggest that these products are different from one another with respect to what they can achieve when they are dosed in the saturating quantity.

當然，我認為其他人也在採取不同的策略。很顯然，看看最終結果如何會很有趣。東尼，你可以發表一下看法，但我認為從科學角度來看，我還沒有看到任何數據表明這些產品在達到飽和劑量時，其效果存在差異。

True, so we've seen the good clinical data. I think there will be clearly a need for a good marketing plan, a good strategy, a good share of voice, and understanding what makes patients move to request this type of medication. The market is hugely un-met at the moment. There are a large amount of patients who are clamoring consistently and looking for help to try and treat this terrible disease. It's a combination of both the clinical science and a good strategy.

沒錯，我們已經看到了良好的臨床數據。我認為，顯然需要製定完善的行銷計劃、有效的策略、提升品牌影響力，並了解是什麼促使患者主動尋求這類藥物。目前市場需求遠未滿足。大量患者持續呼籲，渴望獲得治療這種可怕疾病的方法。這需要臨床科學和有效策略的結合。

With respect to your biosimilar question, Alethia, we've disclosed that we've begun the program, and that's all we're disclosing at this point.

關於你提出的生物相似藥問題，Alethia，我們已經透露我們已經啟動了這個項目，目前我們只能透露這些。

Your next question comes from the line of Michael Yee with RBC Capital Markets.

你的下一個問題來自加拿大皇家銀行資本市場的 Michael Yee。

Hi, good afternoon. A question on Parsabiv, which has a PDUFA date -- the Sensipar franchise is over $1 billion. Can you remind us how to think about the new product versus the loss of exclusivity for Sensipar. There's a swapping. How do we think about that line item as that product comes on?

您好，下午好。關於Parsabiv，我有一個問題，它已經有了PDUFA日期——Sensipar系列產品的價值超過10億美元。您能否提醒我們，如何看待新產品上市與Sensipar獨家銷售權喪失的關係？這涉及到產品置換。隨著新產品上市，我們該如何看待這部分支出？

Then a follow-up on Repatha. Can you remind us how much usage is once monthly now? I assume it's small, but what do you expect that to be over time, once monthly? Thanks.

關於Repatha，還有一點要跟進。您能提醒一下目前每月一次的使用量是多少嗎？我估計不多，但您預計長期來看，每月一次的使用量會是多少？謝謝。

Michael, we're having a little trouble hearing you, but I think you had two questions that Tony can address. The first about Parsabiv, which as you know is the subject of a PDUFA date later this summer. Then with respect to the once-monthly Repatha, I think that's the question Mike was asking.

邁克爾，我們聽不太清楚你說話，但我認為你有兩個問題托尼可以解答。第一個問題是關於帕薩比夫（Parsabiv）的，你知道，它的處方藥價格將於今年夏天晚些時候確定。第二個問題是關於每個月一次的瑞百安（Repatha），我想這就是麥克問的。

Let's start with the Parsabiv question. As you know, Sensipar has been extremely successful in treating patients, both in the US and around the world. But in spite of the efficacy of Sensipar, we probably only have about a 26% penetration. Compliance or patient persistency in this particular market is always an issue, to ensure patients who are on dialysis three times a week actually take their tablets every day, as well.

我們先從Parsabiv的問題說起。如您所知，Sensipar在美國乃至全球範圍內都取得了巨大的成功。但儘管Sensipar療效顯著，其市場滲透率可能只有26%左右。在這個特殊的市場中，患者的依從性或堅持用藥始終是一個問題，我們需要確保那些每週透析三次的患者也能每天按時服藥。

Parsabiv brings a combination of potentially a better level of persistency, because you're being infused while you're having your dialysis. But the second thing is that you're seeing from the clinical data, in fact, there appear to be a much more robust level of efficacy of Parsabiv.

Parsabiv 的優點在於其潛在的更高持續性，因為藥物是在透析的同時輸注的。但其次，從臨床數據來看，Parsabiv 的療效似乎也更為顯著。

CMS have granted us a two-year period that this product will exist outside the bundle while they determine the medical value to determine the value of putting it back in the bundle. We continue to be excited about the product. There are patients who will take oral. There are patients who will take an injectable, and we will see how many patients we can assist with both products.

CMS已批准我們兩年的過渡期，在此期間該產品將獨立於醫保計劃之外，以便他們評估其醫療價值，從而決定是否將其重新納入醫保計劃。我們對該產品依然充滿信心。有些患者會選擇口服，有些患者會選擇注射，我們將觀察有多少患者能夠同時接受這兩種治療。

As regards to Repatha, very little usage at the moment on the monthly dose. We have not had a patient-friendly dose up until now. There appear to be a fair amount of patients who would prefer to have a convenient once-a-month dose. We're spending quite a bit of time talking to cardiologists about this, and we will be coming to market in the next couple weeks.

關於瑞百安（Repatha），目前每月一次的給藥方案使用率很低。此前我們還沒有推出方便患者的給藥方案。似乎有不少患者更傾向於每月一次的給藥方式。我們正在與心臟科醫生就此進行深入探討，並將在未來幾週內將新方案推向市場。

Your next question comes from the line of Robyn Karnauskas with Citigroup.

你的下一個問題來自花旗集團的 Robyn Karnauskas。

Hi, guys, thanks for taking my question. I have a question for David. On M&A, a lot of questions we're getting across the board in biotech on M&A, how are you thinking about how competitive the space is right now for M&A, given that many players are thinking about talking about actually buying things? Do you find the space competitive, and how do you think about time lines? Are people being more realistic about evaluations? Thanks.

大家好，感謝你們回答我的問題。我有個問題想問David。關於併購，我們最近在生技領域收到了很多關於併購的問題。鑑於許多企業都在考慮收購，您認為目前生技領域的併購競爭有多激烈？您覺得這個領域競爭激烈嗎？您如何看待併購的時間安排？大家對併購估值是否更務實了？謝謝。

Sure, yes. I think what I would say about M&A right now is indeed, first of all we have been consistent in indicating that we have a broad set of interests, in particular around the six therapeutic areas where we are particularly focused. We have said that we are open to look at transactions that could range from early to late stage.

當然可以。關於目前的併購情況，我想說的是，首先，我們一直強調我們擁有廣泛的投資興趣，尤其是在我們重點關注的六大治療領域。我們表示，我們對處於早期到後期階段的交易都持開放態度。

I think the point is, we want to make sure we see everything that might be of interest to us, and I think we're seeing that, first of all. Certainly, we're in a financial position to be able to be competitive. Secondly, it's true. We're not the only people out there who are in the market looking for opportunities.

我認為關鍵在於，我們希望確保看到所有可能對我們有價值的東西，而且我認為我們首先做到了這一點。當然，我們的財務狀況足以讓我們保持競爭力。其次，的確如此。市場上尋找機會的並非只有我們。

I think the point for us is we need to make sure that we first of all look at things as to the scientific insight that we can bring to bear, including with our insight from a human genetic perspective. Then secondly, we are very clear that we're going to be disciplined in terms of the financial returns that we can expect. We're interested in doing deals that will create returns for Amgen, not just the sellers. We continue to be active, and we've got a number of pretty interesting prospects that we think could come to closure, including still this year.

我認為對我們來說，關鍵在於首先確保我們能夠運用我們自己的科學洞察力，包括我們從人類遺傳學角度獲得的洞見。其次，我們非常清楚，在預期財務回報方面，我們將保持謹慎。我們感興趣的是能夠為安進公司創造回報的交易，而不僅僅是為賣方創造回報。我們將繼續積極開展業務，我們有一些非常有前景的項目，我們認為這些項目有可能最終完成，其中一些項目甚至可能在今年內完成。

Your next question comes from the line of Geoffrey Porges with Leerink Partners.

你的下一個問題來自 Leerink Partners 的 Geoffrey Porges。

Thanks very much for taking the question. A two-part question on biosimilars and then government effects. Could you talk a little bit about how the proposed Part B changes might play out and potentially affect your business? Secondly, how might that alter the landscape for some of the biosimilars that you're developing, or influence that? Thanks.

非常感謝您回答這個問題。這個問題分為兩部分，分別關於生物相似藥和政府政策的影響。您能否簡要談談擬議的B部分變更可能會如何實施，以及可能對貴公司業務產生的影響？其次，這些變更可能會如何改變或影響您正在開發的某些生物相似藥的市場格局？謝謝。

Let me take that one, if I can. This is Tony. Clearly, Amgen has raised some strong objections and questions to the proposed pilot, together with about at least three hundred other organizations. The concern as always when you do something based on acquisition cost and ASP adjustment, are you ensuring the patient safety and patient concerns are included. It's difficult to make a comment at the moment, Geoff, about something that's not been put into place yet. It's a proposal. It's up there for comment. We're working with other people to make sure if there is a change, patients are protected all the way through.

如果可以的話，讓我來回答這個問題。我是托尼。顯然，安進公司以及至少三百家其他機構對這項試點計畫提出了強烈的反對意見和質疑。一如既往，當基於採購成本和平均售價調整方案時，我們始終關注的問題是：是否確保了病患的安全和顧慮得到充分考慮？傑夫，現在很難對尚未實施的方案發表評論。這只是一個提案，目前正在徵求意見。我們正與其他各方合作，確保即使方案有所變動，病患的權益也能得到全程保障。

Your next question comes from the line of Mark Schonebaum with Evercore ISI.

你的下一個問題來自 Evercore ISI 的 Mark Schonebaum。

Hi, Arvind. Do you actually like Ronny Gal, because I've known him for years, and we should chat. (laughter) I had a question for -- I love Ronny, by the way, total joke. This was touched on here and there, but your margin guidance, David, goes through 2018. We're now dangerously close to 2017. I understand you can't give us any guidance, but can you just talk to us about your latest thoughts qualitatively about where margins could go after the plan that you have announced? Should we expect further modest margin expansion? Should we be modeling something right along the lines you're doing now? Anything like that, I would love to hear you riff on that.

嗨，Arvind。你真的喜歡Ronny Gal嗎？因為我認識他好幾年了，我們應該要聊聊。 （笑）我有個問題想問你──順便說一句，我超愛Ronny，開個玩笑。 David，你之前也零星提到過，你的利潤率預測到2018年。現在離2017年已經很近了。我知道你不能給出具體的預測，但你能不能就你公佈的計劃之後利潤率的走向，定性地談談你最近的想法？我們是否應該預期利潤率會進一步小幅成長？我們是否應該繼續沿用你現在的做法？諸如此類，我很想聽聽你的看法。

Then, Bob, what's your appetite for an at-risk Humira biosimilar launch? Sean, I'd just be curious real fast to get your opinion, you guys have a CETP. I would love to know what your opinion on that class is now, like 30 seconds. Thank you.

鮑勃，你對高風險的阿達木單抗生物類似藥上市有什麼興趣？肖恩，我只是好奇地想快速聽聽你的看法，你們有CETP（臨床試驗和治療專家）。我很想知道你現在對這類藥物的看法，大概30秒吧。謝謝。

Yes, on the first one, on the margin, the margin walk for the Company, I would say as we've been seeing, we're very pleased with the progress that we have made towards the goals we set out for ourselves in 2018. You look at the combination of continued growth of the business. You look at the progress we're making, which by the end of this year we expect to be delivering a $1.1 billion improvement on our cost base versus 2013, and we see us certainly achieving the $1.5 billion that we set out.

是的，關於第一點，也就是利潤率，就公司而言，正如我們所看到的，我們對在實現2018年設定的目標方面取得的進展非常滿意。您可以看看業務的持續成長，以及我們正在取得的進展，我們預計到今年年底，我們的成本基礎將比2013年減少11億美元，而且我們有信心實現我們設定的15億美元的目標。

Likewise, if you look at the progress on the margins where we started at a 38% margin in 2013, you have now seen us this quarter again deliver over 50% on the way to 52% to 54%. First of all, I would say we're pleased with the progress. We're running the Company in an agile and efficient manner while still investing significantly for the long-term health of the business.

同樣，如果您看一下利潤率的進展，就會發現我們2013年起步時的利潤率為38%，而本季度我們再次實現了超過50%的利潤率，並有望達到52%至54%。首先，我想說我們對所取得的進展感到滿意。我們以靈活高效的方式經營公司，同時仍為公司的長期健康發展進行大量投資。

The second point I would make is, we are exactly as of mid-year 2016, now we're halfway through the period through 2018. Quite frankly, while we're making very good progress, I think it would be a mistake for us to take our eye off the ball to continue to focus on delivering against those goals that we have set out for the Company.

第二點是，從2016年中算起，現在已經是2018年中了。坦白說，雖然我們取得了非常好的進展，但我認為如果我們因此放鬆警惕，就應該繼續專注於實現我們為公司設定的目標。

First and foremost, we're looking at delivering on those goals. In due course, we'll be looking then in terms of financial performance beyond that. I think the important point is we think we've got a business that's sustainably delivering very good performance financially, and investing in the innovation and long-term pipeline for the Company.

首先，我們的首要任務是實現這些目標。之後，我們會考慮財務業績方面的其他問題。我認為關鍵在於，我們相信公司目前的業務能夠持續取得非常好的財務業績，並且我們也在投資於公司的創新和長期發展。

Sean, do you want to briefly comment on CETP?

肖恩，你想簡單談談CETP嗎？

Sure. I think that at this point in the game, most folks are really just waiting now to see the Merck CETP study readout. I assume mid-year next year is what we have most recently heard. Before making any final judgments, I would say that the Lilly data did cause folks who were believers in the mechanism to take significant pause. Certainly what we've done is to suspend any investment in this area until we see the Merck data.

當然。我認為目前大多數人都在等待默克CETP研究的結果。據我們所知，結果大概會在明年年中公佈。在做出任何最終判斷之前，禮來的數據確實讓那些相信這種機制的人開始認真考慮。我們目前的做法是暫停在該領域的任何投資，直到看到默克的數據。

Mark, it won't surprise you to know that we're not going to comment on your question about our launch plans for Humira. As I said earlier on the call, the next step is for us to get a regulatory approval for our molecule, and that's what we're focused on securing.

馬克，你肯定不會感到意外，我們不會對你提出的關於修美樂上市計劃的問題發表評論。正如我之前在電話會議中所說，下一步是獲得監管部門的批准，這也是我們目前的工作重點。

Just to make sure that we don't exceed the one hour of our allocated time here, may I request that we limit -- that you limit yourself to just one question so we can get through everybody's questions. Zirmarcus, let's go ahead with the next one, please?

為了確保我們不超過分配的一小時時間，請您每次只提出一個問題，這樣我們才能輪到其他人提問。齊爾馬庫斯，我們開始下一個問題吧？

Yes, your next question is from the line of Ian Somaiya with BMO Capital.

是的，你的下一個問題來自 BMO Capital 的 Ian Somaiya。

Thanks for sneaking me in there. Just a question for Tony. How should we think about the launch of yet another oral for -- in the RA market? Are there any parallels to your experiences with an oral in psoriasis, and the impact it's had on Enbrel sales there?

謝謝你讓我插話。我有個問題想問托尼。我們該如何看待在類風濕關節炎市場推出另一種口服藥物？這和你們之前在乾癬口服藥物方面的經驗，以及它對恩利（Enbrel）在乾癬市場銷售的影響有什麼相似之處嗎？

The first launch of an oral was obviously not that successful. The launch into psoriasis was interesting, because it expanded the market place and brought into the market a number of patients who perhaps were earlier in their disease, who weren't quite ready yet to move onto an injectable biologic. It's quite possible that there are a bunch of patients between methotrexate and a biologic that could become eligible for this opportunity. But if you look at even in psoriasis, the overall market for the TNFs have remained; just the overall market has grown.

口服製劑的首次上市顯然並不成功。而進軍乾癬領域則頗為有趣，因為它拓展了市場，並吸引了一些可能處於疾病早期、尚未準備好接受注射生物製劑治療的患者。很可能在甲胺蝶呤和生物製劑之間還有相當一部分患者符合此治療條件。但即便僅就乾癬領域而言，TNF抑制劑的整體市場仍保持穩定，只是市場規模有所成長。

Your next question comes from the line of Ying Huang with Bank of America Merrill Lynch.

你的下一個問題來自美國銀行美林證券的黃穎。

Ying, are you there? Maybe you have us on mute. Okay, let's go on to the next question.

瑩，你在嗎？你是不是把我們靜音了？好的，我們繼續下一個問題。

The next question comes from Josh Schimmer with Piper Jaffray.

下一個問題來自 Josh Schimmer 和 Piper Jaffray。

Thanks very much for taking the question. I'm just wondering if there is any difference in the dynamics for share loss to Neupogen biosimilar in the 340-B hospital setting versus the non-340-B setting? Can you discuss a little bit how the dynamics there might differ between those two? Thanks.

非常感謝您回答這個問題。我想了解一下，在340-B醫院環境下，Neupogen生物相似藥的市佔率流失動態與非340-B環境是否有差異？您能否簡要討論一下這兩種情況下的動態差異？謝謝。

Again, sorry Josh, it was hard to hear you.

再次抱歉，喬希，我剛才聽不太清楚你說話。

Josh, I think you were talking about the difference between the PHS and the non-PHS, right?

喬希，我想你剛才是在說PHS和非PHS之間的差別，對吧？

Correct.

正確的。

Clearly, I think anyone who has come new into the market has gone after non-PHS hospitals first.

顯然，我認為任何新進入市場的人都會首先瞄準非公共衛生服務 (PHS) 醫院。

What share is PHS versus non-PHS?

PHS病患佔比與非PHS病患佔比為多少？

I couldn't give you that off hand. It's tough to pull that type of data off hand. If you need it, we'll come back to you on that one.

我暫時無法提供給您。這類數據很難立即取得。如果您需要，我們稍後會回覆您。

Your next question comes from the line of Ying Huang with Bank of America Merrill Lynch.

你的下一個問題來自美國銀行美林證券的黃穎。

Looks like Ying is still absent. Okay, let's go on to the next one.

看來瑩還是沒來。好吧，我們繼續下一個。

The next question is from the line of Brian Skorney with Robert W. Baird.

下一個問題來自 Brian Skorney 和 Robert W. Baird 的問題。

Hi, this is Nina on for Brian. I had a question about omecamtiv. I know you said the Phase III protocol has been submitted, but we were just wondering what the gating factors are to starting a Phase III trial? We know the Phase II data has been out for a while now. Are there regulatory issues, or something that's holding it up, or something else?

您好，我是Nina，替Brian問的。我有一個關於omecamtiv的問題。我知道您說過III期臨床試驗方案已經提交了，但我們想了解啟動III期臨床試驗的門檻是什麼？我們知道II期臨床試驗的數據已經公佈一段時間了。是否有監管方面的問題，或是其他原因導致III期臨床試驗無法啟動？

Yes, no, what I would say is we have been moving aggressively with this program. We had to of course go through some meaningful discussions with regulators around things like the dosing algorithms that would be used, the safety of the product and so on, because of the fact that just based on the mechanism there is a narrow therapeutic window for the product.

是的，不，我想說的是，我們一直在積極推進這個專案。當然，我們必須與監管機構就一些問題進行有意義的討論，例如給藥方案、產品安全性等等，因為僅從其作用機制來看，該產品的治療窗口就比較窄。

We're assessing drug levels and have a titration scheme. That's moved along. I think we've been able to design a very robust study, and have decided that we should put it through the special protocol assessment and FDA. Things are actually moving along as fast as I would have expect to on a complex program like this.

我們正在評估藥物濃度並制定了滴定方案。這項工作進展順利。我認為我們已經設計出一項非常嚴謹的研究，並決定將其提交給FDA進行特殊方案評估。對於這樣一個複雜的專案來說，目前的進展速度完全符合我的預期。

As it's getting close to 6PM on the East Coast, Zirmarcus, let's take two more questions.

澤爾馬庫斯，現在美國東部時間快到下午 6 點了，我們再來回答兩個問題。

Okay, your next question comes from the line of Ronny Gal with Bernstein.

好的，你的下一個問題來自 Ronny Gal 與 Bernstein 的對話。

Good afternoon, and thank you for taking my questions. My question is about indication-based pricing in anti-TNF and the broader anti-inflammatory market. How do you guys think about this? Is this good, is this bad? Will it impact Enbrel in a positive way? Are you willing participants, or less so? If you can give us some color?

下午好，感謝您回答我的問題。我的問題是關於抗TNF藥物以及更廣泛的抗發炎藥物市場中基於適應症的定價機制。您對此有何看法？這種定價機制是好是壞？它會對恩利（Enbrel）產生正面影響嗎？您願意參與嗎？還是不太願意？能否詳細解釋一下？

It's Tony. Let me respond to that one as best I can. First of all, Amgen has been really at the forefront of innovative solutions to improve patient access, including innovative contracting such as outcomes-based and risk-based contracting. We are partnering with payers on patient-centered approaches to ensure that patients get access to the best available medications, and that physicians make the right choice for the right patient; and at the same time, the patient share of cost is manageable. As regards indication-specific contracts, I think it's too early at this stage to actually give any comment about what the impact could be.

我是托尼。讓我盡我所能回答這個問題。首先，安進一直致力於提供創新解決方案，以改善患者用藥途徑，包括基於結果和基於風險的創新合約模式。我們與支付方合作，採用以患者為中心的方案，確保患者能夠獲得最佳藥物，醫生能夠為合適的患者做出正確的選擇；同時，患者的自付費用也在可控範圍內。至於針對特定適應症的合同，我認為現在就對其可能產生的影響發表任何評論還為時過早。

Your final question comes from the line of Cory Kasimov with JPMorgan.

你的最後一個問題來自摩根大通的科里·卡西莫夫。

Hi, good afternoon, guys. Thanks for squeezing me in. I wanted to ask about pricing, as well. Really curious on how you think we should be -- how we should be thinking about the sustainability of price increases in this environment? Most specifically when thinking about Enbrel and the four meaningful increases you've had in the last couple years, I assume you're not getting much push-back at the payer level to be able to push these through. But are you comfortable with us modeling this pace of increases to continue, as I think many were assuming this would tail off across the space, given the retort that's out there? Thanks.

大家好，下午好。感謝你們抽出時間。我還想問一下定價方面的問題。我很想知道你們認為我們應該如何看待——在當前環境下，我們該如何考慮價格上漲的可持續性？特別是考慮到恩利（Enbrel）在過去幾年中經歷了四次顯著的價格上漲，我猜想你們在支付方層面並沒有遇到太多阻力，所以才能順利推行這些漲價。但是，鑑於目前市場對價格上漲的反對聲浪，我認為很多人都認為這種漲價速度會逐漸放緩，你們覺得我們繼續保持這樣的漲價速度是否合理？謝謝。

Cory, that question that a lot of people are asking, I'm sure. As you know, we price our products based on the value in the market place, taking into account the value they bring to the payers, the providers, the patients; the competitive landscape itself.

科里，我相信很多人都在問這個問題。如你所知，我們根據產品在市場上的價值來定價，會考慮產品為支付方、醫療服務提供者、病人帶來的價值，以及競爭格局本身。

Enbrel, in particular, of course competes in a highly competitive market place where several large players are competing for form replacements to enable patient access. The health plans and the PBMs negotiate price concessions and large rebates to gain formulary replacement. Because of the magnitude of these rebates, price increases have become part of the competitive dynamic. That's about all I can tell you at the moment.

當然，恩利（Enbrel）所處的市場競爭異常激烈，多家大型製藥公司都在爭奪處方藥替代權，以確保患者能夠獲得該藥物。醫療保險公司和藥品福利管理機構（PBM）透過談判爭取價格優惠和高額回扣，以期獲得處方藥替代權。由於這些回扣金額龐大，價格上漲已成為競爭的一部分。目前我只能告訴你這些。

Great. Thanks, Tony. I would like to also thank everybody for your participation in our call. As you go through our results, if you have added questions, observations, feel free to reach out to me. Myself and my team will be around for several hours. Thanks again.

太好了，謝謝托尼。我也要感謝大家參與我們的電話會議。在查看結果的過程中，如果你們有任何問題或意見，請隨時與我聯繫。我和我的團隊會在接下來的幾個小時內在線上。再次感謝。

Ladies and gentlemen, this concludes Amgen's second-quarter financial results conference call. You may now disconnect.

女士們、先生們，安進公司第二季財務業績電話會議到此結束。您可以斷開連線了。