美國安進 (AMGN) 2018 Q1 法說會逐字稿

My name is Ian, and I will be your conference facilitator today for Amgen's First Quarter 2018 Financial Results Conference Call. (Operator Instructions)

我叫伊恩，今天我將擔任安進 2018 年第一季財務業績電話會議的主持人。（操作說明）

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

現在我謹向大家介紹投資人關係副總裁 Arvind Sood。蘇德先生，您可以開始了。

Okay. Thank you, Ian. Good afternoon, everybody. I would like to welcome you to our conference call for the first quarter of 2018. I think we are off to a solid start with new and recently launched products continuing to deliver volume-driven growth, including our most recent launch of Parsabiv. We also have notable catalyst to look forward to, like our upcoming FDA action date for Aimovig for migraine prevention. Our Chairman and CEO, Bob Bradway, will lead the discussion today with a strategic overview followed by our CFO, David Meline, who will review our results for the first quarter and provide updated guidance for 2018. Tony Hooper, our Head of Global Commercial Operations, will dig into our product performance during the quarter, followed by our Head of R&D, Sean Harper, who will provide a pipeline update.

好的。謝謝你，伊恩。大家下午好。歡迎各位參加我們2018年第一季的電話會議。我認為我們已經取得了穩健的開局，新產品和近期推出的產品持續帶來銷售成長，包括我們最近推出的 Parsabiv。我們還有一些值得期待的重要催化劑，例如 FDA 即將對 Aimovig（用於預防偏頭痛）做出決定。今天，我們的董事長兼首席執行官鮑勃·布拉德韋將主持討論，首先進行戰略概述，隨後我們的首席財務官大衛·梅林將回顧我們第一季度的業績，並提供 2018 年的最新指導。全球商業營運主管 Tony Hooper 將深入分析本季我們的產品表現，隨後研發主管 Sean Harper 將提供產品線更新資訊。

We will use slides corresponding to our prepared comments today. And a link to those slides were sent earlier.

今天我們將使用與我們準備好的發言內容相對應的幻燈片。之前已經發送過這些幻燈片的連結。

We plan on using non-GAAP financial measures in today's presentation to provide information which may be useful in understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results, and reconciliations of these measures are available in the schedules accompanying today's press release, our 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GAAP財務指標，以提供有助於了解我們持續業務表現的資訊。然而，這些非GAAP財務指標應與GAAP結果一併考慮，這些指標的調節表可在今天新聞稿隨附的附表、我們的8-K表格以及我們網站的投資者關係部分中找到。

So just a reminder that some of the statements made during the course of our presentation are forward-looking statements, and our 2018 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

因此，在此提醒大家，我們在演示過程中所作的一些陳述是前瞻性陳述，我們在 2018 年提交的 10-K 表格及後續文件中列出了可能導致我們的實際結果與預期結果存在重大差異的因素。

So with that, I would like to turn the call over to Bob. Mr. Bradway?

那麼，接下來我將把電話交給鮑伯。布拉德韋先生？

Okay. Thank you, Arvind. Thank you all for joining us. As you can see, we're off to a solid start in 2018, with 3% growth in product sales, leading us to 10% growth in non-GAAP earnings per share. We had double-digit unit growth in all of our new and recently launched products, including Repatha, KYPROLIS, Prolia and XGEVA. We also generated strong volume growth outside of the U.S. where our legacy brands have faced competition for some time.

好的。謝謝你，阿文德。感謝各位的參與。如您所見，我們在 2018 年取得了穩健的開局，產品銷售額增長了 3%，帶動非 GAAP 每股收益增長了 10%。我們所有新推出和最近推出的產品都實現了兩位數的銷售成長，包括 Repatha、KYPROLIS、Prolia 和 XGEVA。在美國以外的地區，我們的銷售也實現了強勁成長，而我們的傳統品牌在這些地區已經面臨競爭一段時間了。

Repatha, KYPROLIS, Prolia, XGEVA, and soon, Aimovig, are clear examples of innovative medicines that address real unmet needs. These will be important drivers of our long-term growth. In addition, we continue to invest in R&D to develop new game-changing medicines like omecamtiv, tezepelumab and, in the earlier stage, molecules like our IL-2 mutein, all of which have clear potential value propositions for patients and society.

Repatha、KYPROLIS、Prolia、XGEVA 以及即將上市的 Aimovig 都是創新藥物的典型例子，它們能夠解決真正的未滿足需求。這將是我們長期成長的重要驅動力。此外，我們繼續投資研發，以開發像omecamtiv、tezepelumab這樣的顛覆性新藥，以及處於早期階段的像我們的IL-2突變體這樣的分子，所有這些藥物都對患者和社會具有明確的潛在價值。

In addition, the broad promise of our BiTE platform is coming into focus across a number of molecules in our cancer pipeline. The recent approval for BLINCYTO in ALL patients with minimal residual disease gives us confidence in this approach to immuno-oncology for both liquid and solid tumors.

此外，我們的 BiTE 平台的廣泛應用前景正在我們癌症研發管線中的許多分子中逐漸顯現。BLINCYTO 近期獲準用於治療 ALL 患者的微小殘留病灶，讓我們對這種免疫腫瘤學方法在血液腫瘤和實體瘤治療中的應用充滿信心。

We're looking forward to launching Aimovig, our first neuroscience therapeutic, which is, in turn, a first-in-class CGRP antibody for migraine prevention.

我們期待推出 Aimovig，這是我們的首個神經科學療法，它是一種用於預防偏頭痛的首創 CGRP 抗體。

Together with Novartis, we're ready to launch Aimovig this quarter in the U.S. We hope to redefine migraine prevention for relevant patients, physicians and payers, given the urgent unmet need and the pent-up demand for a better therapy in this disease. Current therapies do not adequately address this debilitating disease, and migraine has gone underappreciated and under-treated for too long.

我們與諾華公司攜手，準備在本季在美國推出Aimovig。鑑於目前迫切的未滿足需求以及對這種疾病更好療法的強烈需求，我們希望能夠為相關患者、醫生和支付方重新定義偏頭痛的預防。目前的治療方法不足以有效治療這種使人衰弱的疾病，偏頭痛長期以來一直未得到應有的重視和治療。

Later this year, we'll see our biosimilar effort begin to come to fruition as we launch AMGEVITA, our biosimilar of HUMIRA, internationally. We have a compelling opportunity to leverage our decades of biotechnology experience to create and reliably supply high-quality biosimilars to patients worldwide. While gaining regulatory approval of biosimilars has proven challenging for many in the field, we have successfully executed on our plans receiving first cycle approvals for AMGEVITA and MVASI, our biosimilar to Avastin.

今年晚些時候，我們將看到我們的生物相似藥研發工作開始取得成果，屆時我們將面向國際市場推出我們的生物相似藥 AMGEVITA，它是 HUMIRA 的生物相似藥。我們擁有絕佳的機會，可以利用我們數十年的生物技術經驗，為世界各地的患者創造並可靠地供應高品質的生物相似藥。儘管對許多業內人士來說，獲得生物相似藥的監管批准已被證明是一項挑戰，但我們已成功執行了我們的計劃，獲得了 AMGEVITA 和 MVASI（我們的 Avastin 生物類似藥）的首輪批准。

We have our next opportunity for approval with KANJINTI, our biosimilar version of Herceptin, on May 28 in the U.S.

我們下一個獲得批准的機會是 5 月 28 日，屆時我們的生物相似藥 KANJINTI（赫賽汀的生物相似藥）將在美國上市。

We believe biosimilars can be an important growth opportunity for us as we begin to launch our products globally.

我們相信，隨著我們開始在全球推出產品，生物相似藥可以成為我們重要的成長機會。

Our balance sheet and after-tax cash flows are strong, enabling us to invest in long-term innovative growth opportunities and to return capital to our shareholders. Our priorities for the use of cash continue to be investment in innovation and supporting the launches of our growth products while continuing to build out our global presence.

我們的資產負債表和稅後現金流都很強勁，使我們能夠投資長期的創新成長機會，並向股東返還資本。我們現金使用的優先事項仍然是投資於創新和支援成長型產品的推出，同時繼續擴大我們的全球業務。

Following tax reform, we announced plans to build a new state of the art next-generation biomanufacturing facility in Rhode Island, which will result in creation of many new, highly skilled jobs. This new plant, which is the first of its kind in the United States, will employ Amgen's proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets.

稅制改革之後，我們宣布計劃在羅德島州建造一座最先進的下一代生物製造工廠，這將創造許多新的高技能就業機會。這家新工廠是美國第一個此類工廠，將採用安進成熟的下一代生物製造技術，為美國和全球市場生產產品。

As for business development, we continue to look for innovative opportunities that are consistent with our areas of strategic focus, while remaining disciplined about the path to earning return for our shareholders.

在業務發展方面，我們將繼續尋找符合我們策略重點領域的創新機會，同時保持嚴謹的態度，為股東創造回報。

We have a strong track record of returning capital to our shareholders, which we plan to maintain. Since initiating our dividend 7 years ago, we have raised it, on average, 25% a year, while also returning excess capital through significant programmatic share buybacks, like those which we've undertaken this year.

我們一直以來都以向股東返還資本為己任，我們計劃繼續保持這一良好記錄。自 7 年前開始派發股息以來，我們平均每年將股息提高 25%，同時透過大規模的計劃性股票回購（例如我們今年進行的回購）返還多餘的資本。

Briefly addressing the political environment, let me say that over the coming weeks and months, we will continue to work with Congress and the administration to advocate for policies that improve the affordability and access to important new medicines while seeking ways to constructively modernize the Medicare program.

簡要談談政治環境，我想說，在接下來的幾周和幾個月裡，我們將繼續與國會和政府合作，倡導提高重要新藥的可負擔性和可及性的政策，同時尋求建設性地使醫療保險計劃現代化的方法。

In closing, let me just thank all of our Amgen staff around the world. As I look at our business today and into the future, our outlook remains strong as we continue to deliver for patients and shareholders.

最後，請容許我感謝安進公司在全球的所有員工。展望我們目前的業務和未來，隨著我們繼續為患者和股東創造價值，我們的前景仍然強勁。

Let me turn the call now to David.

現在我把電話轉給大衛。

Okay. Thanks, Bob. We're pleased with our solid revenue and earnings growth in the first quarter as our transformation efforts continue to enable investments in support of volume-driven growth during a time of portfolio transition.

好的。謝謝你，鮑伯。我們對第一季穩健的營收和獲利成長感到滿意，因為我們的轉型努力將繼續進行投資，以支持在投資組合轉型時期實現銷售驅動型成長。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $5.6 billion in the first quarter grew 2% year-over-year. Worldwide product sales at $5.3 billion in the first quarter grew 3% year-over-year as strong unit demand for our new products outweighed declines in our mature brands.

接下來請看投影片第6頁的財務表現。第一季全球營收達 56 億美元，年增 2%。第一季全球產品銷售額達 53 億美元，較去年同期成長 3%，這主要得益於新產品強勁的銷售需求抵銷了成熟品牌銷售下滑的影響。

We are particularly encouraged by our 11% year-over-year volume growth in Europe, reflecting the value of our innovative products in a market where we have experienced biosimilar competition and portfolio transition for a number of years.

我們尤其感到鼓舞的是，我們在歐洲的銷售量年增了 11%，這反映了我們創新產品的價值。多年來，我們在這個市場經歷了生物相似藥的競爭和產品組合的轉型。

Other revenues at $211 million decreased $54 million year-over-year due to an unfavorable compare related to milestone payments received in Q1 of 2017, partially offset by higher royalty income in Q1 of this year.

其他收入為 2.11 億美元，年減 5,400 萬美元，原因是 2017 年第一季收到的里程碑付款存在不利的比較基數，但今年第一季更高的特許權使用費收入部分抵消了這一影響。

Non-GAAP operating income at $3 billion grew 1% from prior year. Non-GAAP operating margin was 56.9% for the first quarter. As in prior years, our operating margin is expected to be lower in the remaining quarters of the year, driven by the timing of expenses.

非GAAP營業收入為30億美元，較上年成長1%。第一季非GAAP營業利益率為56.9%。與往年一樣，受費用發生時間的影響，預計今年剩餘幾季的營業利潤率將有所下降。

As mentioned last quarter, we continue to evaluate incremental investments in our products and pipeline as well as external opportunities to drive growth and maximize shareholder value.

正如上個季度所提到的，我們將繼續評估對產品和研發管線的增量投資，以及外部機會，以推動成長並最大限度地提高股東價值。

On a non-GAAP basis, cost of sales as a percent of product sales improved by 0.4 points to 12.7%, driven by lower royalty expense, partially offset by increasing manufacturing costs.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比下降了0.4個百分點，達到12.7%，這主要得益於特許權使用費支出的降低，但部分被不斷上漲的製造成本所抵銷。

Research and development expenses at $739 million, were relatively unchanged in the first quarter of 2018 versus last year. Research and development as a percent of product sales at 13.8% is lower in Q1, consistent with previous years.

2018 年第一季研發費用為 7.39 億美元，與去年同期相比基本維持不變。第一季研發投入佔產品銷售額的比例為 13.8%，低於往年同期水準。

Going forward, research and development expense as a percent of product sales is expected to normalize to around 2017 levels.

展望未來，研發費用佔產品銷售額的比例預計將恢復到 2017 年左右的水平。

SG&A expenses increased 6% on a year-over-year basis, primarily driven by launch preparations for Aimovig and our biosimilar products, in addition to making greater investments in Prolia to capitalize on its full potential.

銷售、一般及行政費用年增 6%，主要原因是為 Aimovig 和我們的生物相似藥產品進行上市準備，以及加大對 Prolia 的投資以充分發揮其潛力。

Similar to our R&D expense profile, the SG&A percentage of sales is traditionally lowest in Q1, and we expect the full year to normalize at or above 2017 levels as we continue to invest in our launch and growth products.

與我們的研發費用情況類似，銷售、一般及行政費用佔銷售額的比例通常在第一季度最低，我們預計隨著我們繼續投資於上市和增長產品，全年將恢復到 2017 年的水平或更高。

In aggregate, non-GAAP operating expenses increased 2% year-over-year. We remain on track to exceed our 2018 commitment of $1.5 billion in transformation savings, while investing those savings to launch and support new products, build out new therapeutic areas, advance our biosimilar business, increase our global presence and continue to provide meaningful returns to shareholders. Other income and expenses were a net $182 million expense in Q1. This is unfavorable by $51 million on a year-over-year basis.

整體而言，非GAAP營運費用年增2%。我們仍有望超額完成 2018 年轉型節約 15 億美元的承諾，同時將這些節約下來的資金用於推出和支持新產品、拓展新的治療領域、推進我們的生物相似藥業務、擴大我們的全球影響力，並繼續為股東帶來有意義的回報。第一季其他收入和支出淨額為 1.82 億美元。與上年同期相比，這不利了 5,100 萬美元。

The non-GAAP tax rate was 13.7% for the quarter, a 4.8 point decrease versus the first quarter of 2017, reflecting the lower U.S. federal statutory rate due to tax reform.

本季非GAAP稅率為13.7%，比2017年第一季下降了4.8個百分點，這反映了由於稅收改革導緻美國聯邦法定稅率降低。

Non-GAAP net income increased 6% and non-GAAP earnings per share increased 10% year-over-year for the first quarter to $3.47 per share.

第一季非GAAP淨利年增6%，非GAAP每股盈餘較去年同期成長10%，達到每股3.47美元。

Turning next to cash flow and the balance sheet on Page 7.

接下來請翻到第 7 頁查看現金流量表和資產負債表。

Free cash flow was $2.6 billion for the quarter, driven by higher net income. As expenses normalize for the remainder of the year, we would expect free cash flow in subsequent quarters to be somewhat reduced from Q1 levels. In addition, earlier this month, we paid $600 million, which represented the first of 8 annual installments of the cash repatriation tax. This payment will impact our Q2 free cash flow.

受淨利潤成長的推動，本季自由現金流為26億美元。隨著今年剩餘時間支出逐漸恢復正常，我們預計後續幾季的自由現金流將比第一季的水準下降。此外，本月初，我們支付了 6 億美元，這是現金匯回稅 8 年分期付款中的第一筆。這筆款項將影響我們第二季的自由現金流。

We continue to provide significant cash returns to shareholders, consistent with our commitments, as we deployed $10.8 billion in Q1 to repurchase 56.4 million shares. We plan to repurchase an incremental $2 billion to $4 billion of our shares in Q2.

我們繼續履行承諾，為股東提供豐厚的現金回報，第一季我們投入 108 億美元回購了 5,640 萬股股票。我們計劃在第二季額外回購價值 20 億至 40 億美元的股票。

Additionally, our first quarter dividend increased to $1.32 per share, an increase of 15% over last year. Cash and investments totaled $32.2 billion, a decrease of approximately $6.2 billion from the first quarter of last year. This decrease reflects the successful execution of our Dutch auction tender offer in Q1, in addition to our significant buyback and dividend deployments over the past 12 months, offset by our free cash flow generation during that same period. Our debt balance stands at $35.5 billion as of March 31, carrying a weighted average interest rate of 3.8% and an average maturity of 12 years.

此外，我們第一季的股息增加到每股 1.32 美元，比去年增長了 15%。現金及投資總額為 322 億美元，比去年第一季減少了約 62 億美元。這一下降反映了我們在第一季成功執行了荷蘭式拍賣要約收購，以及過去 12 個月的大量股票回購和分紅，但同時也被我們同期產生的自由現金流所抵消。截至 3 月 31 日，我們的債務餘額為 355 億美元，加權平均利率為 3.8%，平均期限為 12 年。

Turning to the outlook for the business for 2018 on Page 8. We remain on track with our plans to continue to invest in our pipeline, build out our global presence and increase spend in support of long-term volume growth across large patient populations. Today, we are revising our 2018 guidance, which reflects our solid Q1 growth as well as the revised tax outlook.

接下來請看第 8 頁關於 2018 年業務展望的內容。我們將繼續按計劃投資於我們的研發管線，拓展我們的全球業務，並增加支出以支持在龐大的患者群體中實現長期銷售成長。今天，我們修訂了 2018 年的業績預期，這反映了我們第一季穩健的成長以及修訂後的稅收前景。

Overall, our revised revenue guidance is $21.9 billion to $22.8 billion versus previous guidance of $21.8 billion to $22.8 billion. This reflects -- this continues to reflect a range of potential Sensipar generic competition outcomes as well as new potential competition for Neulasta and Aranesp, at the same time, contemplating the year-to-date sales performance for calcimimetics portfolio.

整體而言，我們修訂後的營收預期為 219 億美元至 228 億美元，而先前的預期為 218 億美元至 228 億美元。這反映了——這繼續反映了Sensipar仿製藥競爭的各種潛在結果，以及Neulasta和Aranesp的新潛在競爭，同時，也考慮了鈣敏感受體激動劑產品組合今年迄今為止的銷售業績。

With regard to our non-GAAP earnings per share guidance, we are revising the outlook to $12.60 to $13.70 a share versus prior guidance of $12.60 to $13.70.

關於我們的非GAAP每股盈餘預期，我們將預期從先前的每股12.60美元至13.70美元調整為每股12.60美元至13.70美元。

Further, we are revising our non-GAAP tax rate guidance to 13.5% to 14.5% versus prior guidance of 14% to 15% as we have realized some favorable one-time items in 2018 associated with the implementation of tax reform. We continue to expect capital expenditures of approximately $750 million this year.

此外，由於我們在 2018 年實現了與稅收改革實施相關的一些有利的一次性項目，我們將非 GAAP 稅率預期從先前的 14% 至 15% 調整為 13.5% 至 14.5%。我們預計今年的資本支出仍約為 7.5 億美元。

This concludes the financial update. I now turn the call over to Tony.

財務更新到此結束。現在我把電話交給東尼。

Thank you, David, and good afternoon, everyone. You'll find our product sales starting on Slide #10. Our business continues to shift to more volume-driven growth as we continue to launch innovative products targeting large patient populations with unmet medical needs. We're off to a solid start to the year with all of our newer products delivering double-digit growth. The total portfolio grew at about 3% as the legacy brands offset some of those volume growth.

謝謝你，大衛，大家下午好。我們的產品銷售資訊從第 10 張投影片開始。隨著我們不斷推出針對大量存在未滿足醫療需求的患者群體的創新產品，我們的業務正持續向以銷售驅動的成長模式轉變。今年開局良好，所有新產品均實現了兩位數的成長。由於傳統品牌抵消了部分銷售成長，整體產品組合成長了約 3%。

As has been the trend for the last number of quarters, our ex-U. S. business continues to grow more rapidly, generating 7% growth, excluding the impact of foreign exchange, fueled by 9% volume growth.

正如過去幾個季度以來的趨勢一樣，我們的除美國以外的美國業務持續快速成長，在不計匯率影響的情況下，實現了 7% 的成長，這主要得益於 9% 的銷售成長。

In many of our ex-U. S. markets, we already experienced a majority of the decline of our mature brands, demonstrating the growth potential of our newer portfolio. These markets serve as a model for the overall company's future growth profile.

在我們許多前美國。在美國市場，我們已經經歷了大部分成熟品牌的衰落，這表明我們較新的產品組合具有成長潛力。這些市場為公司未來的整體成長前景提供了參考模型。

We're also in deep preparation for the upcoming launches of Aimovig for migraine sufferers and the first of our biosimilar portfolio.

我們也在為即將推出的治療偏頭痛的 Aimovig 以及我們的首個生物相似藥產品組合做著充分的準備。

A majority of the sales teams are trained and in place and subsequent investment levels will continue ramping up throughout the year.

大部分銷售團隊已經完成培訓並到位，後續的投資水準將在今年持續增加。

Let me now turn to our brand performance. Prolia, the leading brand osteoporosis therapy, grew 16% year-over-year primarily from volume. We continue to drive growth of new patients as well as improved repeat injection rates.

現在讓我來談談我們的品牌表現。領先的骨質疏鬆症治療品牌 Prolia 年增 16%，主要得益於銷售成長。我們持續推動新患者數量的成長，並提高重複注射率。

This results in an increasing share of postmenopausal osteoporosis segment as patients and physicians realize the benefit value of Prolia. As a reminder, given its 6-month dosing interval, Prolia exhibits a seasonal sales pattern with quarter 1 and quarter 3 representing lower sales than quarters 2 and 4. Overall market penetration, however, is still low in the 20%, indicating significant potential for improved diagnosis and treatment. With its unique profile and through increased investment, we expect Prolia will remain a very strong growth driver.

隨著患者和醫生逐漸認識到 Prolia 的益處，停經後骨質疏鬆症患者所佔比例也隨之增加。需要提醒的是，由於Prolia的給藥間隔為6個月，其銷售呈現季節性模式，第一季和第三季的銷售額低於第二季和第四季。然而，整體市場滲透率仍然很低，僅為20%，這表明在診斷和治療方面仍有很大的改進空間。憑藉其獨特的優勢和不斷增加的投資，我們預計 Prolia 將繼續保持強勁的成長勢頭。

Let's now move to the oncology, starting with KYPROLIS. KYPROLIS grew 17% year-on-year, driven primarily by our ex-U. S. business. The majority of second-line usage in Europe is in the triplet regimen and KYPROLIS is continuing to take market share from Velcade.

現在我們來談談腫瘤學，首先從 KYPROLIS 開始。KYPROLIS 年成長 17%，主要得益於我們除美國以外的業務成長。美國商業。在歐洲，二線治療主要採用三聯療法，KYPROLIS 正繼續從 Velcade 奪取市場份額。

In the U.S., the overall multiple myeloma market, defined as all lines of treatment, grew in the first quarter. KYPROLIS has stable share but room to grow in the second-line segment. Our focused message to physicians remain clear. Patients who have relapsed will actually live longer when treated with regimens that include KYPROLIS.

在美國，整個多發性骨髓瘤市場（定義為所有治療線）在第一季實現了成長。KYPROLIS 在二線市場擁有穩定的市場份額，但仍有成長空間。我們向醫生傳達的訊息依然明確。復發患者接受包含 KYPROLIS 的治療方案後，實際上會活得更久。

XGEVA grew 11% year-over-year, primarily from volume. Although we believe more than half of this growth is from a buy in that should burn off over the coming quarters.

XGEVA年增11%，主要得益於銷售成長。儘管我們認為超過一半的成長來自買入，而這部分成長應該會在未來幾季內消退。

Since our label expansion into multiple myeloma in January 2018, our team has been emphasizing XGEVA's clinical benefits of preventing skeletal-related events in patients with multiple myeloma. It's still early days, but anecdotally, we are receiving positive feedback from physicians and institutions as many multiple myeloma patients cannot receive optimal therapy with bisphosphonates.

自 2018 年 1 月我們將 XGEVA 的適應症擴展至多發性骨髓瘤以來，我們的團隊一直強調 XGEVA 在預防多發性骨髓瘤患者骨骼相關事件方面的臨床益處。雖然現在還處於早期階段，但據傳聞，我們收到了來自醫生和機構的正面回饋，因為許多多發性骨髓瘤患者無法透過雙磷酸鹽獲得最佳治療。

While we are not providing a slide, let me comment on the other products in our oncology portfolio. The combined sales of Nplate, Vectibix, IMLYGIC and BLINCYTO exceeded $400 million in the quarter. Sales growth of these brands at 16%, 15%, 20% and 44%, respectively, was driven primarily by volume growth, with some benefit from the buyout during the quarter. I'm particularly pleased by the performance of BLINCYTO, which is our first product in the BiTE platform. You will hear more about this from Sean as well as his views on other products emerging from the platform.

雖然我們沒有提供幻燈片，但請允許我介紹我們腫瘤產品組合中的其他產品。本季度，Nplate、Vectibix、IMLYGIC 和 BLINCYTO 的合併銷售額超過 4 億美元。這些品牌的銷售額分別成長了 16%、15%、20% 和 44%，主要由銷售成長推動，本季收購也帶來了一定收益。我對 BLINCYTO 的表現尤其滿意，這是我們在 BiTE 平台上的首款產品。你將從肖恩那裡聽到更多關於這方面的信息，以及他對該平台上其他產品的看法。

Turning now to Neulasta. Neulasta sales decreased 5% year-over-year as we continue to see a slight decline in the use of myelosuppressive chemotherapeutic agents. We also saw a small buy-in that will burn off in the second quarter.

現在轉向紐拉斯塔。由於骨髓抑制性化療藥物的使用持續略有下降，Neulasta 的銷售額比去年同期下降了 5%。我們也看到少量買入資金將在第二季消耗掉。

We continue to drive adoption of Onpro in the U.S. and exited quarter 1 at a 62% share. Onpro's utilization in the U.S. market further underscores the value of this patent-protected technology in providing convenience for patients and lower rates of hospitalization due to febrile neutropenia. We expect to see more global utilization of Onpro in 2018. As a reminder, we recently received positive CHMP opinion for Onpro in Europe and are in the late stages of launch preparation in several markets.

我們繼續推動 Onpro 在美國的普及，第一季末市佔率達到 62%。Onpro 在美國市場的使用進一步凸顯了這項受專利保護的技術的價值，它為患者提供了便利，並降低了因發燒性中性粒細胞減少症而住院的幾率。我們預計2018年Onpro將在全球範圍內得到更廣泛的應用。再次提醒大家，我們最近收到了歐洲藥品管理局 (CHMP) 對 Onpro 的正面意見，目前已進入多個市場上市準備的最後階段。

For NEUPOGEN, we continue to compete effectively, holding just under 40% market share of the short-acting market in the U.S. as we exit quarter 1. This is after 4-plus years of facing competition.

對於紐寶根而言，我們繼續保持有效的競爭優勢，截至第一季末，我們在美國短效市場佔有近 40% 的市場份額。這是在經歷了 4 年多的競爭之後取得的成績。

Moving on to Enbrel. Sales declined 6% year-over-year with market growth and volume trends consistent with recent quarters, which stands in contrast to the trend break in market growth experienced in quarter 1 2017. Recall that during quarter 1, patients experienced insurance reverification and resetting of deductibles, some of which resulted in higher patient assistance cost relative to later quarters. Consistent with our prior disclosure, we continue to expect 2018 net selling price to decline slightly versus 2017.

接下來是恩利。銷售額年減 6%，市場成長和銷售趨勢與最近幾季一致，這與 2017 年第一季市場成長趨勢的中斷形成鮮明對比。回想一下，在第一季度，患者經歷了保險重新核實和免賠額重置，其中一些導致患者援助成本相對於後來的季度增加。與我們先前的揭露一致，我們仍然預計 2018 年淨售價將比 2017 年略有下降。

While early days, the launch of ENBREL Mini with AutoTouch has been met with very positive feedback from both patients and customers and we're excited about this opportunity this innovative, patient-centric delivery system provides. As a final note, purchasing patterns or the supply chain for Enbrel can cause quarterly fluctuations. As we noted previously, quarter 1 represents the lowest quarter of the year, slightly over 20%, with the balance distributed fairly evenly through the rest of the year.

雖然ENBREL Mini with AutoTouch的推出尚處於早期階段，但它已經獲得了患者和客戶的非常積極的反饋，我們對這種以患者為中心的創新給藥系統所帶來的機會感到興奮。最後要指出的是，恩利（Enbrel）的採購模式或供應鏈可能會導致季度波動。正如我們之前提到的，第一季是一年中最低的季度，略高於 20%，其餘部分則較為均勻分佈在一年中的其他時間。

Unit declines, net selling price trends for the balance of the year are expected to continue, consistent with those seen in quarter 1.

預計今年剩餘時間銷售將持續下降，淨售價趨勢與第一季的情況一致。

Switching now to our ESA portfolio. Slide #18 shows the quarter 1 2018 composition of our ESA business and provides a year-on-year growth percentage for the different segments. EPOGEN declined 10% year-over-year, underlying volume remains relatively stable, while we recognized a lower net selling price as a result of our extended supply agreement with DaVita.

現在切換到我們的ESA產品組合。第 18 張幻燈片顯示了我們 ESA 業務 2018 年第一季的組成，並提供了不同細分市場的同比增長率。EPOGEN 年比下降 10%，基本銷量保持相對穩定，同時由於我們與 DaVita 延長了供應協議，淨售價有所下降。

Aranesp declined 11% year-over-year with lower unit demand of 8%, primarily based on increased competition. Recall that last quarter, we provided disclosure that a long-acting competitor had extended their product more broadly into the small to midsized dialysis centers. And we expect to lose some of these businesses as early as quarter 1 2018. We have volume and share-based contracts with some of these customers and we'll continue to compete on an account by account basis.

由於競爭加劇，Aranesp 的銷售量較去年同期下降了 11%，單位需求量下降了 8%。回想一下，上個季度我們揭露了一家長期競爭對手已將其產品更廣泛地擴展到中小型透析中心的情況。我們預計最早在 2018 年第一季就會失去其中一些業務。我們與其中一些客戶簽訂了基於銷售和份額的合同，我們將繼續逐一客戶競爭。

We're also prepared to compete for the potential short-acting biosimilar in all customer segments including hospitals and oncology clinics if and when such a biosimilar is approved by the FDA.

如果FDA批准某種短效生物相似藥，我們也準備好在所有客戶群（包括醫院和腫瘤診所）中競爭。

Our long track record of safety, efficacy and reliable supply is a competitive advantage.

我們在安全性、有效性和可靠供應方面長期以來的良好記錄是一項競爭優勢。

Turning now to calcimimetrics. We have launched Parsabiv in several markets including the U.S. and is off to a strong start. As the head-to-head clinical data showed, Parsabiv demonstrated a greater level of efficacy when compared to Sensipar. Since they're administered in the patient's existing IV line during dialysis, it puts control in the hands of the health care provider, which could also drive an improved level of adherence. Nephrologists continue to be positive and are excited about having this product available.

現在轉向鈣計量學。我們已在包括美國在內的多個市場推出了 Parsabiv，並且取得了強勁的開局。臨床對比數據顯示，與Sensipar相比，Parsabiv表現出更高的療效。由於這些藥物是在透析期間透過患者現有的靜脈輸液管給藥，因此控制權掌握在醫療保健提供者手中，這也有助於提高患者的依從性。腎臟科醫生們依然持樂觀態度，並對該產品的上市感到興奮。

In the U.S., so far, we have a solid uptake in the midsized dialysis providers. The larger freestanding dialysis clinics continue to run pilots to determine the eventual treatment protocols. We expect to see adoption increase gradually over time.

在美國，到目前為止，我們在中型透析服務提供者中已經取得了不錯的迴響。規模較大的獨立透析診所繼續進行試點項目，以確定最終的治療方案。我們預計隨著時間的推移，採用率會逐步提高。

Turning now to Sensipar, where year-over-year growth was 18%. As a reminder, the reimbursement mechanism for Sensipar in the U.S. changed from Part D to Part B in the beginning of 2018, which also altered the supply chain for patients, most of them now receive Sensipar directly from the dialysis provider versus more traditional pharmacies.

現在來看 Sensipar，其年成長率為 18%。提醒一下，美國 Sensipar 的報銷機制在 2018 年初從 D 部分改為 B 部分，這也改變了患者的供應鏈，他們中的大多數人現在直接從透析提供者那裡獲得 Sensipar，而不是從傳統的藥房獲得。

We believe that providers ordered additional supply during quarter 1 in order to minimize potential patient treatment interruption. We also believe that the new supply chain is now normalized and quarterly volume should return to more historical run rates, assuming continued exclusivity and taking to account some transition to Parsabiv.

我們認為，供應商在第一季訂購了額外的物資，以盡量減少對患者治療的潛在幹擾。我們還認為，新的供應鏈現在已經正常化，假設獨家經營繼續進行，並考慮到向 Parsabiv 的一些過渡，季度銷售應該會恢復到更歷史的運行速度。

As David mentioned, the 2018 outlook for Sensipar is still somewhat uncertain given the ongoing litigation. It is, of course, conceivable that competitors may be able to bring generic products to market at some point in 2018, although we believe we have a strong litigation position.

正如大衛所提到的那樣，鑑於正在進行的訴訟，Sensipar 2018 年的前景仍然有些不確定。當然，競爭對手有可能在 2018 年的某個時候將仿製藥推向市場，儘管我們相信我們在訴訟方面處於強勢地位。

With Repatha, we continue to compete effectively, maintaining a majority share on a global basis. With OUTCOMES data in our Repatha label, our team have been speaking directly to the benefits of treating patients with Repatha and its ability to reduce the risk of heart attack by 27% and stroke by 21%.

憑藉 Repatha，我們繼續保持有效的競爭力，在全球範圍內保持多數市場份額。透過 Repatha 標籤中的 OUTCOMES 數據，我們的團隊直接向患者說明了使用 Repatha 治療的益處，以及它能夠將心臟病發作的風險降低 27%，將中風的風險降低 21%。

Repatha grew 151% year-over-year, primarily from volume. Overall fulfillment rates in the U.S. continue to improve as utilization and management criteria evolves.

Repatha 年增 151%，主要得益於銷售成長。隨著利用率和管理標準的不斷提高，美國的整體訂單履行率持續改善。

Over the past few months, we've seen access to Repatha continue to improve and we remain committed to ensuring access and affordability for high-risk cardiovascular patients.

在過去的幾個月裡，我們看到 Repatha 的可近性持續改善，我們將繼續致力於確保高風險心血管疾病患者能夠獲得該藥物並負擔得起。

We've been negotiating with several payers for months to expand patient access to Repatha and offering significant discounts with multiple offers pending.

幾個月來，我們一直在與多家支付方進行談判，以擴大患者獲得瑞百安（Repatha）的途徑，並提供大幅折扣，目前還有多項優惠正在洽談中。

As the market leader, a majority of new PCSK9 inhibitor prescriptions are for Repatha, the only PCSK9 inhibitor approved by the FDA to prevent heart attacks and strokes in patients with established ASCV disease.

作為市場領導者，大多數新的 PCSK9 抑制劑處方都是針對 Repatha，這是 FDA 批准的唯一一種用於預防已確診 ASCV 疾病患者的心臟病發作和中風的 PCSK9 抑制劑。

In addition, we have unequivocally demonstrated that treating patients to the lowest LDL level possible is the best treatment approach, including for patients with baseline LDL levels as low as 70 milligrams per deciliter.

此外，我們已明確證明，將患者的 LDL 水平降至最低是最好的治療方法，包括基線 LDL 水平低至每分升 70 毫克的患者。

Our priority remains reaching the large population of high-risk cardiovascular patients.

我們的首要任務仍然是接觸到大量高風險心血管疾病患者。

The cost to society of not treating these patients is unacceptable and we're looking at all options to improve access for appropriate high-risk patients.

不治療這些患者對社會造成的損失是不可接受的，我們正在研究所有方案，以改善合適的、高風險患者的就醫途徑。

We also look forward to having the Repatha labels updated and expanded with the OUTCOMES data outside the U.S. soon.

我們也期待 Repatha 標籤能夠盡快更新，並納入美國以外地區的 OUTCOMES 資料。

Let me finish what I started. We continue to transition to a portfolio exemplified by volume-driven growth with performance in many countries outside the U.S. as proof point.

讓我完成我開始的事情。我們正持續向以銷售驅動成長為特徵的投資組合轉型，在美國以外的許多國家的業績就是最好的證明。

A majority of our brands grew double digits. Our performance in our mature brands as well as some of the new ones demonstrate our ability to compete. This gives us confidence as we prepare for our upcoming launches.

我們的大多數品牌都實現了兩位數的成長。我們在成熟品牌和一些新品牌上的表現證明了我們具備競爭力。這讓我們對即將推出的產品充滿信心。

So let me close by thanking all the Amgen staff that worked so hard to get these important products to patients and for the strong start to 2018.

最後，我要感謝安進公司所有辛勤工作的員工，感謝他們為病人提供這些重要的產品，也感謝他們為 2018 年取得的良好開端。

Now I'll pass you to Sean.

現在我把麥克風交給肖恩。

Thanks, Tony, and good afternoon. I'll begin my comments today with a brief overview of some key milestones from Q1, and then highlight a few early-stage innovative programs we find particularly promising.

謝謝你，托尼，下午好。今天，我將首先簡要概述第一季的一些關鍵里程碑，然後重點介紹我們認為特別有前景的幾個早期創新項目。

We recently received several important regulatory decisions in Europe, including the approval of an expanded indication for XGEVA to prevent skeletal-related events in patients with multiple myeloma. We also received several positive opinions from the CHMP, including recommendations for the addition of our cardiovascular OUTCOMES data to the Repatha label, a Neulasta label variation to include the Onpro kit and a marketing authorization for KANJINTI, our biosimilar Herceptin. I would note that KANJINTI has a BsUFA action date next month in the United States.

我們最近在歐洲收到了幾項重要的監管決定，其中包括批准 XGEVA 擴大適應症，用於預防多發性骨髓瘤患者的骨骼相關事件。我們還收到了 CHMP 的幾項積極意見，包括建議將我們的心血管結果數據添加到 Repatha 標籤中，建議對 Neulasta 標籤進行更改以包含 Onpro 試劑盒，以及建議批准我們的生物類似藥 Herceptin KANJINTI 上市。我注意到，KANJINTI 在美國的 BsUFA 行動日期是下個月。

Also in the U.S., BLINCYTO received accelerated approval in orphan designation for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia with minimal residual disease, or MRD.

在美國，BLINCYTO 也獲得了孤兒藥資格的加速批准，用於治療患有微小殘留疾病（MRD）的 B 細胞前體急性淋巴細胞白血病的成人和兒童。

There are now technologies that allow for exquisite sensitivity in detecting, at a molecular level, whether residual disease is present.

現在的技術能夠以極高的靈敏度在分子層面上檢測是否有殘留疾病。

MRD is the strongest prognostic factor for relapse in ALL patients. And in our phase II study of ALL patients in complete remission that were positive for MRD, 81% achieved MRD negativity after a single cycle of BLINCYTO. This was the first step for approval for the treatment of MRD by FDA, and we're gratified that our first BiTE therapy has meaningfully advanced the oncology field.

MRD是ALL患者復發最強的預後因子。在我們對處於完全緩解期且 MRD 陽性的 ALL 患者進行的 II 期研究中，81% 的患者在接受一個療程的 BLINCYTO 治療後達到了 MRD 陰性。這是 FDA 批准 MRD 治療的第一步，我們很高興我們的首個 BiTE 療法在腫瘤學領域取得了實質進展。

This approval represents a paradigm shift, not only in the treatment of ALL, but also potentially in other diseases where extremely potent therapies are being employed. As such, we're incorporating MRD into all of our clinical studies as appropriate and we continue to develop therapies that drive deep and durable responses.

這項批准代表著範式轉變，不僅在急性淋巴性白血病 (ALL) 的治療方面，而且可能在其他採用強效療法的疾病方面也具有潛在意義。因此，我們將酌情把 MRD 納入我們所有的臨床研究，並繼續開發能夠帶來深度和持久療效的療法。

For the first time, there's talk of actually achieving cures in what have been fatal diseases, and we're excited to help lead the way.

現在，人們第一次開始談論治癒一些曾經是致命的疾病，我們很高興能夠引領這一進程。

We have the opportunity to highlight preclinical data from several of our Phase I assets at the American Association for Cancer Research meeting early this month.

本月初，我們將有機會在美國癌症研究協會會議上重點介紹我們幾個 I 期臨床試驗計畫的臨床前數據。

The anti-apoptotic family members, Mcl-1 and Bcl-2, are understood to play key roles in the pathogenesis of acute myeloid leukemia, or AML, a grievous disease that affects 4x as many people as ALL, with approximately 20,000 new cases and 10,000 deaths per year in the United States alone.

抗凋亡家族成員 Mcl-1 和 Bcl-2 被認為在急性髓性白血病 (AML) 的發病機制中起著關鍵作用。 AML 是一種嚴重的疾病，其發生人數是 ALL 的 4 倍，僅在美國每年就有約 20,000 例新病例和 10,000 例死亡。

At AACR, we presented promising data, showing marked improvements in activity and potency with the combination of our Mcl-1 inhibitor, AMG 176, and the Bcl-2 inhibitor, venetoclax, compared to either agents alone in preclinical settings. A Phase I study of AMG 176's monotherapy is currently enrolling relapsed or refractory multiple myeloma and AML patients.

在 AACR 會議上，我們展示了有希望的數據，顯示與臨床前研究中單獨使用 Mcl-1 抑制劑 AMG 176 或 Bcl-2 抑制劑 venetoclax 相比，二者合併使用在活性和效力方面有顯著提高。AMG 176 單藥療法的 I 期研究目前正在招募復發或難治性多發性骨髓瘤和 AML 患者。

We also discussed our unique ability to target the antigen, DLL3, very exciting target, with both BiTE and CAR T technologies. Small cell lung cancer is an aggressive disease with very poor outcomes and accounts for about 10% to 15% of all lung cancers. Despite this, there have been no significant advances in the treatment of this devastating disease in decades. DLL3 expression is highly restricted to small cell lung cancer and we have developed 2 very potent modalities for clinical testing, AMG 757, our half-life extended BiTE, that's currently enrolling patients in Phase 1; and AMG 119, our DLL3 CAR T developed with Kite that we expect to begin enrolling very soon.

我們也討論了我們利用 BiTE 和 CAR T 技術靶向抗原 DLL3（一個非常令人興奮的標靶）的獨特能力。小細胞肺癌是一種侵襲性很強的疾病，預後很差，約佔所有肺癌的 10% 到 15%。儘管如此，幾十年來，這種毀滅性疾病的治療並沒有取得重大進展。DLL3 表達高度局限於小細胞肺癌，我們已經開發了 2 種非常有效的臨床試驗方法：AMG 757，我們半衰期延長的 BiTE，目前正在進行 1 期臨床試驗並招募患者；以及 AMG 119，我們與 Kite 合作開發的 DLL3 CAR T，我們預計很快就會開始招募患者。

We are really anxious to see the effects of targeting DLL3 with immuno-oncology approaches, which we believe will be more effective compared to a traditional antibody or antibody drug conjugate approach.

我們非常渴望看到用免疫腫瘤學方法靶向 DLL3 的效果，我們相信這種方法比傳統的抗體或抗體藥物偶聯物方法更有效。

We also presented preclinical data characterizing our half-life extended BCMA BiTE for multiple myeloma, AMG 701, and our FLIP 3 CAR T program for AML. At the Society of Interventional Radiology meeting in March, we presented Phase I safety data from our hepatic injection study of IMLYGIC, and we're now moving into Phase II in combination with KEYTRUDA in hepatocellular carcinoma and a number of tumor types with liver metastases.

我們也展示了臨床前數據，這些數據描述了我們用於治療多發性骨髓瘤的半衰期延長的 BCMA BiTE、AMG 701 以及我們用於治療急性髓性白血病的 FLIP 3 CAR T 計畫。在 3 月的介入放射學會會議上，我們展示了 IMLYGIC 肝臟注射研究的 I 期安全性數據，現在我們正在進行 II 期研究，將 IMLYGIC 與 KEYTRUDA 聯合用於治療肝細胞癌和多種肝轉移性腫瘤。

All of these programs underscore our differentiated multi-modality approach to our immuno-oncology platform where in addition to IMLYGIC, we're currently advancing more than 1 dozen early stage BiTE molecules, with 7 already in the clinic, and 3 CAR Ts through our collaboration with Kite. We're particularly interested in the potential for BiTE in solid tumors and we've been seeing some very encouraging early activity.

所有這些項目都強調了我們針對免疫腫瘤學平台採取的差異化多模式方法，除了 IMLYGIC 之外，我們目前還在推進 12 個早期 BiTE 分子，其中 7 個已經進入臨床階段，並透過與 Kite 的合作推進 3 個 CAR T 療法。我們對 BiTE 在實體瘤中的應用潛力特別感興趣，並且已經看到了一些非常令人鼓舞的早期療效。

We look forward to initial clinical data from AMG 420, our BCMA BiTE for multiple myeloma, and AMG 330, our CD33 BiTE for AML, by the end of this year.

我們期待在今年年底前獲得 AMG 420（用於治療多發性骨髓瘤的 BCMA BiTE）和 AMG 330（用於治療急性髓性白血病的 CD33 BiTE）的初步臨床數據。

Briefly on Aimovig, our CGRP receptor antagonist antibody, we continue to work with FDA toward our May 17 PDUFA action date, and data are being presented today at the American Academy of Neurology from a study in patients with migraine, who have previously failed 2 to 4 preventive treatments. These unique results add to the consistent body of evidence for Aimovig across the spectrum of migraine patients from treatment-naive through those who have failed multiple therapies.

關於我們的 CGRP 受體拮抗劑抗體 Aimovig，我們繼續與 FDA 合作，爭取在 5 月 17 日獲得 PDUFA 批准。今天，我們將在美國神經病學學會上發表一項針對偏頭痛患者的研究數據，這些患者先前接受過 2 至 4 次預防性治療均告失敗。這些獨特的結果進一步證實了 Aimovig 對各種偏頭痛患者（從初治患者到多種療法失敗的患者）的療效。

Finally, I'd like to spend a few minutes on one of our early inflammation programs, AMG 592 and IL-2 mutein. Current therapies for autoimmune diseases suppress the immune system. While this approach is effective in therapies such as Enbrel have changed the practice of medicine, significant unmet need remains for many of these diseases. In a normally functioning immune system, regulatory T cells or Tregs maintain balance between self and nonself recognition by negatively regulating effector cells. In the autoimmune disease state, this balance is off, favoring the effector cells with impaired Treg responses, having been identified in multiple human diseases, including through human genetics.

最後，我想花幾分鐘時間介紹我們早期的發炎治療計畫之一：AMG 592 和 IL-2 突變體。目前治療自體免疫疾病的療法都是抑制免疫系統。雖然這種方法在恩利等療法中取得了成功，改變了醫學實踐，但對於許多此類疾病而言，仍然存在巨大的未滿足需求。在正常運作的免疫系統中，調節性 T 細胞或 Tregs 透過對效應細胞進行負調控來維持自身辨識和非自身辨識之間的平衡。在自體免疫疾病狀態下，這種平衡被打破，有利於效應細胞，而 Treg 反應受損，這已在多種人類疾病中被發現，包括透過人類遺傳學。

IL-2 is the dominant growth factor for Tregs, but in its native form, it has significant toxicity associated with administration. With AMG 592, we designed an IL-2 mutein with an extended half-life that prevents -- preferentially binds to the IL-2 receptor so as to selectively promote Treg growth and function. At last year's American Society of Hematology meeting, we presented Phase Ia data in healthy volunteers that showed a single dose of AMG 592 was well-tolerated and resulted in dose-dependent increases in Tregs with minimal increases in effector cells, as shown on Slide 30.

IL-2 是 Tregs 的主要生長因子，但其天然形式具有顯著的毒性。我們利用 AMG 592 設計了一個半衰期延長的 IL-2 突變體，它能優先與 IL-2 受體結合，選擇性地促進 Treg 的生長和功能。在去年的美國血液學會會議上，我們展示了健康志願者的 Ia 期數據，結果顯示單劑量 AMG 592 耐受性良好，並導致 Treg 細胞劑量依賴性增加，而效應細胞增加極少，如幻燈片 30 所示。

Based on these exciting results, we've already initiated proof of concept studies in graft -- chronic graft versus host disease, rheumatoid arthritis and systemic lupus erythematosus.

基於這些令人振奮的結果，我們在移植領域啟動了概念驗證研究——慢性移植物抗宿主疾病、類風濕性關節炎和系統性紅斑狼瘡。

We're very excited about the potential for AMG 592 and believe that this approach could be quite powerful in a number of inflammatory diseases.

我們對 AMG 592 的潛力感到非常興奮，並相信這種方法在治療多種發炎性疾病方面可能非常有效。

In closing, I want to thank our staff for their dedication to developing breakthrough medicines for the benefit of patients. Bob?

最後，我要感謝我們的員工，感謝他們為造福病患而致力於研發突破性藥物。鮑伯？

Okay. Thank you, Sean. Ian, why don't we turn over to our question time now, and perhaps you could remind our callers of the procedure for asking questions.

好的。謝謝你，肖恩。伊恩，我們現在進入問答環節吧，或許你可以提醒一下聽眾提問的流程。

(Operator Instructions) Our first question is from the line of Geoffrey Meacham from Barclays.

（操作員說明）我們的第一個問題來自巴克萊銀行的傑弗裡·米查姆。

Tony, for Aimovig, I know we're close to the launch and I realize it's competitive but maybe if you could help us with kind of how you see the size and scale of the commercial organization? And from a reimbursement perspective, maybe what are the lessons to be learned from the PCSK9 experience when you look to the migraine launch?

Tony，對於 Aimovig，我知道我們即將推出產品，也意識到競爭很激烈，但也許你能幫我們談談你對商業組織的規模和體量的看法嗎？從報銷的角度來看，在展望偏頭痛藥物上市時，或許可以從 PCSK9 的經驗中學到哪些教訓？

Geoff, let me try and answer it in 2 ways. As you know, we're going to market together with Novartis. Novartis have a rich history of presence in the neuroscience market, both in terms of the sales force and an outstanding medical organization. We are complementing it with both teams calling on specialists as well as some of the primary care physicians who have a propensity to look after patients with severe headaches or migraines. From a timing perspective, we clearly are in the lead. We look forward to launching first. Unlike the PCSK9 situation where we had to follow, we will actually set the price ourselves, and this is clearly a market where patients have huge symptoms and actually know when they're not being properly treated. So we look forward to a large bulk of patients who want to come with this drug as quickly as possible.

傑夫，我試著用兩種方式回答這個問題。如您所知，我們將與諾華公司共同開拓市場。諾華在神經科學市場擁有悠久的歷史，無論是在銷售團隊還是在傑出的醫療組織方面。我們正在透過兩個團隊聯繫專家以及一些擅長治療嚴重頭痛或偏頭痛患者的初級保健醫生來補充這種做法。從時間上看，我們顯然處於領先地位。我們期待率先發布。與 PCSK9 的情況不同，我們不必再聽從他人的安排，我們將自己定價。顯然，這是一個患者症狀嚴重且清楚自己是否得到正確治療的市場。因此，我們期待大量患者盡快帶著這種藥物前來就診。

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

下一個問題來自德意志銀行的安德魯彼得斯。

Maryana Breitman for Andrew Peters. I wanted to ask about possible strategic moves. Do you see (inaudible) like new platform or technical capability? Or individual products and what stage products would those be?

瑪麗安娜·布雷特曼代表安德魯·彼得斯。我想問一下可能的策略舉措。您認為（聽不清楚）是像新平台或技術能力之類的東西嗎？或單一產品，以及這些產品屬於哪個階段？

Well, I'm afraid your phone line was breaking up so we couldn't hear the question. Do you want to try to repeat that? And then, Ian, if we can't hear it this time, maybe you can recycle her towards the bottom end of the call. Sorry, why don't you try again. Let's see if we can hear you.

恐怕您的電話線路斷斷續續，所以我們沒聽到您的問題。你想再試一次嗎？然後，伊恩，如果我們這次聽不到，也許你可以把她放到通話的後半段。抱歉，請再試一次。我們看看能不能聽到你的聲音。

Can you hear me now?

現在能聽到我說話嗎？

Not great. Why don't we get you on a different line and ask our operator, Ian, to help you get back in the queue.

不太好。我們不如幫您換一條線路，請我們的接線生伊恩幫您重新排隊。

While we cycle her back through, our next question is from the line of Terence Flynn from Goldman Sachs.

在我們再次介紹她的時候，我們的下一個問題來自高盛的 Terence Flynn。

Bob, I think, previously, on some of the prior calls, you referred to excess capacity in the system. I was just wondering if you can update us on your latest thoughts there, particularly in light of some of the consolidation we're seeing on the services side of the industry.

鮑勃，我想，在之前的幾次通話中，你提到過系統中的過剩產能。我只是想問您能否向我們介紹您最近的想法，特別是考慮到我們目前在行業服務領域看到的一些整合現象。

Nothing new, Terence. As I said in my remarks, we're continuing to look at ways to use our balance sheet to strengthen the business, continuing to look at ways to invest in innovation. So we've made our, I think, our points on that topic well-known, and I wouldn't say there's been any change over the course of the last quarter.

沒什麼新鮮的，特倫斯。正如我在演講中所說，我們將繼續尋找利用資產負債表來加強業務的方法，並繼續尋找投資創新的方法。所以，我認為我們已經就此主題充分錶達了我們的觀點，而且我認為在過去一個季度中沒有任何變化。

And our next question is from the line of Christopher Raymond from Piper Jaffray.

我們的下一個問題來自 Piper Jaffray 的 Christopher Raymond。

Just one question on Enbrel. I'm kind of struck, Tony, by your prepared comments. And I know you talked about this last quarter that Q1 would represent, like you said, 20% of the annual number for full year '18. Now just doing the math, I think, that would infer Enbrel revenue of about $5.5 billion for the full year. And I know you guys don't want to give guidance, if any, more granular than you've already given. But that number is a lot bigger than consensus and it would actually implies an up year-on-year number, which would seem to be a reversal from what we saw 2016 to 2017. So I just wonder if you could verify that? If, first of all, if that math is right, maybe sort of talk about the driver there in terms of that trend reversal.

關於恩利（Enbrel），我只有一個問題。東尼，你事先準備好的發言稿讓我有點驚訝。我知道你上個季度說過，正如你所說，第一季將佔 2018 年全年業績的 20%。簡單計算一下，我認為，這可以推斷出 Enbrel 全年的收入約為 55 億美元。我知道你們不想提供比已經提供的更詳細的指導（如果有的話）。但這個數字比普遍預期要大得多，實際上意味著同比上升，這似乎與我們在 2016 年至 2017 年看到的情況相反。所以我想請您幫忙確認一下？首先，如果這個數學計算是正確的，也許可以談談這個趨勢逆轉的驅動因素。

So let me confirm again that quarter 1 was normally a fairly low quarter because of the need for reverification, for the need for the reset of deductibles. So patients picked up in the second quarter. We said last quarter that we expected this quarter to be about 20% of the total annual revenue and it probably landed up being at about 21%, almost 22% of what I expect the full year to be. So my number don't get as high as yours.

因此，我再次確認，第一季通常是業績相對較低的季度，因為需要重新核實，需要重置免賠額。因此，第二季度患者數量增加。我們上個季度預計本季營收將佔全年總營收的 20% 左右，而最終可能達到了全年營收的 21% 左右，接近全年營收的 22%。所以我的數字沒有你的高。

And our next question is from the line of Ying Huang from Bank of America Merrill Lynch.

下一個問題來自美國銀行美林證券的黃穎。

I was wondering, maybe Tony, can you comment on the recent ICER draft analysis on the cost benefit on Aimovig? And they actually proposed a range of the pricing. Would you actually take that into your consideration when you price Aimovig?

東尼，我想問你，你能否對ICER最近發布的關於Aimovig成本效益的分析草案發表一些看法？他們實際上提出了一系列定價方案。在為Aimovig定價時，您會把這一點考慮在內嗎？

Ying, so a couple of things. One, it is a draft publication by ICER. They are requesting public comments up to and including, I think, the 8th of May. So a number of organizations are busy commenting on that. It is the second publication, obviously, if you remember, that there have already been one publication which took place on the 23rd of March in the Journal of Medical Economics, authored by a number of headache specialists and economists which laid out a very clear value range for this particular category. The ICER report doesn't seem to take into account things such as absenteeism and presentism, which we would argue is really an important thing to look at from both an employee perspective and an employer perspective. But all of these ranges fall within a reasonable level that we will be discussing with the payers.

瑩，有幾件事。第一，這是 ICER 的出版草案。他們徵求公眾意見的截止日期是5月8日（含當日）。因此，許多組織都在忙著對此發表評論。顯然，這是第二篇相關出版品。如果你還記得的話，先前在 3 月 23 日的《醫學經濟學雜誌》上已經發表過一篇由多位頭痛專家和經濟學家撰寫的文章，該文章為這一特定類別制定了一個非常清晰的價值範圍。ICER 的報告似乎沒有考慮到缺勤和出勤主義等問題，我們認為，無論從員工角度或雇主角度來看，這都是一個非常重要的問題。但所有這些範圍都在合理的範圍內，我們將與付款方進行討論。

And our next question is from the line of Alethia Young from Crédit Suisse.

我們的下一個問題來自瑞士信貸的 Alethia Young。

Just a question on AMG 592. Just curious if there's any kind of particular preclinical work that suggests an opportunity favors maybe lupus, RA or GvHD? Or is it kind of still an open question. Is there also the possibility for less frequent dosing there?

關於AMG 592，我有個問題。我只是好奇是否有任何特定的臨床前研究表明，這種療法可能對狼瘡、類風濕性關節炎或移植物抗宿主疾病（GvHD）有益？或者說，這仍然是一個懸而未決的問題？是否有可能減少給藥頻率？

So this is a half-life extended kind of a construct that we've designed. And I think that we have some -- of course, we have preclinical models of these diseases but I would say that when you're working with such a different mechanism than has ever been applied to autoimmune disease before, our faith in the predictive nature of these animal models of diseases like lupus and RA and so on is modest. So we use all kinds of scientific reasoning in the animal models to guide us into kind of the initial set of experiments that we chose. But it's fair to say that like was the case when, for example, TNF inhibitors came available, or IL-17 and so on, it's ultimately important to screen through humans with these diseases to determine whether they -- the mechanism can be fruitful.

所以，這是我們設計的一種延長半衰期的結構。我認為我們有一些——當然，我們有這些疾病的臨床前模型，但我想說的是，當你研究的機制與以前應用於自體免疫疾病的機制如此不同時，我們對這些動物模型（如狼瘡和類風濕性關節炎等疾病）的預測能力的信心是有限的。因此，我們在動物模型中運用各種科學推理來引導我們進行最初選擇的一系列實驗。但公平地說，就像 TNF 抑制劑或 IL-17 等藥物問世時的情況一樣，最終重要的是要對患有這些疾病的人進行篩檢，以確定這些藥物——這種機制是否有效。

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

下一個問題來自花旗銀行的 Robyn Karnauskas。

This is (inaudible) on for Robyn. So like you mentioned earlier, you're conducting therapies using multiple modes such as BiTEs and CAR Ts to target the same indications. I know you have a lot in the pipeline. I was just wondering if you can take us through your thought process on how you decide to target the same indication with 2 different modalities? Or how you decide to go in one direction versus the other?

這是（聽不清楚）羅賓的節目。正如您之前提到的，您正在使用多種模式（如 BiTE 和 CAR T 療法）進行治療，以針對相同的適應症。我知道你有很多項目正在籌備中。我想請您詳細介紹一下，您是如何決定用兩種不同的方式來治療相同的疾病？或者說，你如何決定走哪條路？

Right. So it's a good question. I mean, the first thing I would point out is that, at the moment, moving into the clinic, we really just have a few CAR Ts and we've deliberately matched a couple of them with BiTEs so that we could actually scientifically determine pros and cons of these technologies because the data that exists today are very much apples and oranges in terms of the patient populations and the way that they've been preconditioned, for example, before being treated with, let's say, CAR-T cell versus BLINCYTO, even when you get into diseases that are, on the surface, the same, ALL, for example, or the various forms of CD19-positive lymphoma. So I don't want to give you the -- you to get the impression that for lots and lots of our targets, we have double programs. We have a couple that are designed specifically to, hopefully, in humans, give us some understanding of whether the benefit/risk looks better for one of these type of technologies versus another. And so that's kind of an approach and we'd like to understand that in both hematologic and in solid tumor settings. Ultimately, what will determine what we will move forward with is, primarily in oncology, is going to be efficacy, right, with an acceptable amount of safety. And what we really don't know yet is whether you can get some generally similar kind of a clinical benefit from, for example, a BiTE intervention versus a CAR T. It would be hard to imagine that you would select the CAR T after those circumstances given lots of practical considerations, cost of goods, things of that sort. So these are -- it's early days. I don't think anyone has ever really made these comparisons. There's a lot of speculation. And we're hoping to shed some actual light on these clinical questions.

正確的。所以，這確實是個好問題。我的意思是，首先我要指出的是，目前在臨床應用方面，我們只有少數CAR-T細胞療法，並且我們特意將其中幾種與BiTEs療法進行匹配，以便我們能夠科學地確定這些技術的優缺點，因為就患者群體和他們接受預處理的方式而言，目前的數據非常不具有可比性，例如，在接受CAR-T細胞療法的陽性治療之前，例如淋巴瘤形式的陽性疾病，例如腫瘤或治療。所以我不想讓你們產生這樣的印象：對於我們的許多目標，我們都有雙重計畫。我們有幾款專門設計的試驗品，希望透過人體試驗，能夠幫助我們了解這類技術中哪一種的效益/風險比另一種更好。所以這是一種方法，我們希望了解它在血液腫瘤和實體腫瘤治療中的應用。最終，決定我們下一步發展方向的，主要是在腫瘤學領域，將是療效，對吧？當然，安全性也要達到可接受的水準。我們目前尚不清楚的是，例如，BiTE 介入與 CAR-T 療法是否能帶來大致相似的臨床效益。考慮到許多實際因素，例如成本等等，很難想像在這種情況下你會選擇 CAR-T 療法。所以現在還處於早期階段。我認為以前沒有人真正做過這樣的比較。有很多猜測。我們希望能夠對這些臨床問題給予一些實際的解答。

And our next question is from the line of Geoffrey Porges from Leerink partners.

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

Sean, you listed in your development model since, still romosozumab in both the U.S. ready for submission and European review. Could you give us an update on your expectations for the labeled indication and the sort of size of the addressable patient population for romosozumab now?

Sean，你在你的開發模型中列出的 romosozumab 在美國仍然準備提交審批，並在歐洲接受審查。您能否向我們介紹一下您對 romosozumab 適應症的預期，以及目前該藥物可涵蓋的患者群體規模？

Sure. Yes, I think that with romo, we're at this point where we're well into a process of scouring the entire clinical database experience with the molecule to make sure that we have every cardiovascular event that may have occurred in any of the trials and then run them through a new blinded adjudication process. And while that may sound easy, it's actually quite time-consuming and requires coordination between us and another clinical center, in this case, TIMI. So that's underway. And I think the results of that are going to be very important in determining where we end up with the product. Obviously, the unmet need for this kind of anabolic product is very strong, the compelling need for it. The efficacy was very favorable and it's a short period of treatment, 1 year. So I think that what we really need to understand is do we believe that there's actually a cardiovascular risk? Because as you know, Jeff, we have 2 studies. They can't both be true. One of them says there's a risk, the other one says no. So if we get some additional information from this reanalysis, it could tip the scales in one direction or the other. We're just seeking the truth and then whatever the truth is will make its way into the labeling. So it's a little bit hard to know where that benefit/risk will land and whether we'll be talking about a patient population that has a particularly significant level of unmet need and therefore it makes sense to use it in a context in which we actually believe there's a cardiovascular risks versus -- that the cardiovascular risks seems to be much less of a true phenomenon. So that's the best I can do to characterize it at this moment.

當然。是的，我認為對於羅莫（Romo），我們目前正處於深入研究整個臨床資料庫的階段，以確保我們掌握所有試驗中可能發生的每起心血管事件，然後透過新的盲法裁定程序進行分析。雖然這聽起來很容易，但實際上卻非常耗時，並且需要我們與另一個臨床中心（在本例中是 TIMI）進行協調。這件事正在進行中。我認為，這些結果對於決定我們最終的產品走向至關重要。顯然，對這類合成代謝產品的需求非常強烈，迫切需要這種產品。療效非常好，而且療程很短，只有1年。所以我覺得我們真正需要了解的是，我們是否相信確實有心血管風險？傑夫，你知道的，我們有兩個研究。它們不可能同時為真。其中一人說有風險，另一人說沒有風險。因此，如果我們從這次重新分析中獲得一些額外信息，就可能改變結果的走向。我們只是在尋求真相，而真相自然會反映在標籤上。因此，很難確定這種益處/風險最終會落在哪裡，以及我們討論的是否是一個存在特別顯著未滿足需求的患者群體，因此在真正相信存在心血管風險的情況下使用它才有意義，還是說心血管風險似乎遠非一種真實現象。這就是我目前能對它做出的最佳描述。

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

下一個問題來自傑富瑞集團的麥可葉。

I had a question for Bob. I mean, I guess, there was a large M&A deal in the space last week. But I guess, more important, big picture, your view of the environment given that there has not been that many deals. Do you feel for Amgen it is more of a case of not finding things that are good fits or it's a price issue. I guess, maybe you could maybe talk about the overall dynamic when you are looking at all of these different biotech companies?

我有個問題想問鮑伯。我的意思是，我猜，上週這個領域發生了一筆大型併購交易。但我想，更重要的是，從大局來看，考慮到目前還沒有達成太多協議，您對環境議題的看法是什麼？你覺得安進公司面臨的問題是找不到合適的產品，還是價格問題？我想，或許您可以談談您在考察所有這些不同的生技公司時所看到的整體動態？

I think we have a track record of being pretty disciplined in the way we evaluate targets. Our focus is on being confident that we have a pathway for our shareholders to earn a return but we're looking for ways to invest in our industry. We're interested in innovation that aligns well with our 6 therapeutic areas that we focus in and opportunities that are consistent with our desire to advance innovation globally. But I think, Mike, historically, the valuations have been challenged in this sector. We see a little bit of adjustment taking place now and we'll continue to be thoughtful in reviewing all the different opportunities that we think can help us earn a return for our shareholders and help make a difference for patients.

我認為我們在評估目標方面一直保持著相當嚴謹的態度。我們關注的重點是確保股東能夠獲得回報，但我們也在尋找投資我們所在產業的方法。我們對與我們重點關注的 6 個治療領域高度契合的創新感興趣，也對符合我們在全球範圍內推進創新願望的機會感興趣。但我認為，麥克，從歷史角度來看，這個行業的估值一直受到質疑。我們看到目前正在進行一些調整，我們將繼續認真審視所有我們認為可以幫助股東獲得回報並為患者帶來改變的機會。

And our next question is from the line of Eric Schmidt from Cowen and company.

我們的下一個問題來自 Cowen 公司的 Eric Sc​​hmidt。

Maybe a question for Tony on Repatha. Since the presentation of the ODYSSEY data, have you seen any changes in market share? Or any change in your pricing discussions with payers?

或許可以問托尼一個關於瑞百安的問題。自 ODYSSEY 數據發布以來，您是否觀察到市場佔有率有任何變化？或者，您與付款方的價格談判是否有任何變化？

Eric, we saw an increase in the NBRxs after the OUTCOMES data came into Repatha's label. Since the ACC, we've seen relatively little change in the marketplace to date.

Eric，在 Repatha 的標籤中納入 OUTCOMES 資料後，我們看到 NBRxs 有所增加。自 ACC 以來，我們迄今為止看到的市場變化相對較小。

And our next question is from the line of Umer Raffat from Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

Bob, my question is there's been a lot of investor feedback on a possible merger of equal, like a transformative deal between Amgen and a big pharma name, a European pharma name in particular. How do you feel about a transformative M&A situation? Is that something you're open to philosophically? Or is the focus really more on biotech?

鮑勃，我的問題是，投資者對安進與一家大型製藥公司（尤其是一家歐洲製藥公司）之間可能進行的平等合併有很多反饋意見，例如一項具有變革意義的交易。您如何看待具有改變意義的併購事件？你從哲學角度來說是否能接受這種觀點？或者，重點其實更放在生技領域？

Our focus, Umer, is on finding opportunities to invest in innovation where, again, we think we can make a difference, innovation that's focused in areas that are important to us and opportunities that enable us to continue to expand our global footprint. So I think speculation rises and falls through time in our industry, but our focus on those things has been consistent, as has our determination to have a pathway to earn a return for our shareholders through our business development activities.

Umer，我們的重點是尋找投資創新的機會，我們認為我們可以在這些領域有所作為，這些創新專注於對我們重要的領域，以及能夠讓我們繼續擴大全球影響力的機會。所以我認為，在我們這個行業，投機行為會隨著時間的推移而起伏，但我們對這些事情的關注始終如一，我們透過業務發展活動為股東創造回報的決心也始終如一。

And our next question is from the line of Cory Kasimov from JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

I wanted to ask about CGRP and recognizing the competitive nature of this class. But with the article out this morning commenting on Express Scripts' intention to push for lower list prices on the CGRP class to limit out-of-pocket costs borne by patients and implement a pay-for-performance type of model, would you say this is consistent with the interactions you've have had with payers. And maybe how you're thinking about different pricing models for this class following on the heels of some of the more unconventional pricing scheme as you've implemented for PCSK9s?

我想詢問一下CGRP課程的情況，並了解這門課程的競爭性質。但今天早上發表的文章評論了 Express Scripts 打算推動降低 CGRP 類藥物的標價，以限制患者自付費用並實施按績效付費的模式，您認為這與您與支付方的互動一致嗎？鑑於您之前為 PCSK9 類藥物實施了一些非常規的定價方案，您是否正在考慮為這類藥物製定不同的定價模型？

So Cory, let me start that one and then I'll ask Sean to talk about some of these differentiations between our product and the others that are trying to come to market. Clearly, we are in the lead, as I said. And coming to market first is important. It allows us to set the baseline price. We have looked very carefully at the value-based pricing we come forward. We've listened to the affordability question in the marketplace. We're delighted to hear that ESI is looking at value-based prices and look forward to them opening up access in those situations to allow access to appropriate patients. And we will continue to come forward with prices that are responsible, that take into account the co-pay requirements as best we can. We have a number of risk-based contracts on the table with Repatha and we're quite prepared to talk to payers about risk-based contracts with Aimovig. So let me ask Sean to talk a little bit about why we think this drug is actually very different to the others coming to market.

那麼，Cory，就讓我先開始吧，然後我會請Sean談談我們的產品與其他正在嘗試進入市場的產品之間的一些區別。正如我所說，我們顯然處於領先地位。搶佔市場先機至關重要。它允許我們設定基準價格。我們已經非常仔細地研究了我們提出的基於價值的定價策略。我們已經聽取了市場上關於價格承受能力的問題。我們很高興聽到 ESI 正在考慮基於價值的定價，並期待他們在這些情況下開放准入，使合適的患者能夠獲得治療。我們將繼續推出合理的價格，並儘可能考慮到共同支付的要求。我們已經與 Repatha 簽訂了多項基於風險的合同，我們完全準備好與支付方討​​論與 Aimovig 簽訂基於風險的合約。那麼，我想請肖恩談談，為什麼我們認為這種藥物與即將上市的其他藥物非常不同。

Well, Tony, I think that there's a number of things to just point to in terms of the advantage besides being first to market. First of all, we are a receptor antagonist and that is still the case. We're the only receptor antagonist in the clinic. And we chose that path for a number of reasons, but one of them was potency. And so we seem to be the only product that doesn't require loading doses or intravenous administration which can be quite an awkward thing for patients and providers, in general. We recently developed the data and this is being presented today in this population and -- of highly refractory patients who failed as many as 4 prior prophylactic therapies and the data look really strong in that group. And so that's a differentiated data set. And I think, also, remember that when physicians are dealing with patients and the idiosyncratic thumb, either adverse reactions or lack of -- or presence of efficacy, they have to choose between different agents within a class. And generally speaking, a physician, if they started with, for example, one of the ligand sequestering antibodies, going to another ligand sequestering antibody doesn't make a whole lot of sense compared to trying a receptor antagonist. So we hope that the receptor, us being the only receptor antagonist, would result in more therapeutic sort of options for physicians who are trying to manage this very challenging condition.

托尼，我認為除了率先進入市場之外，還有很多其他優勢值得一提。首先，我們是受體拮抗劑，這點至今仍然如此。我們是目前臨床上唯一一種受體拮抗劑。我們選擇這條路有很多原因，其中之一就是效力。因此，我們似乎是唯一不需要負荷劑量或靜脈注射的產品，這對患者和醫護人員來說通常都是相當尷尬的事情。我們最近獲得了相關數據，今天將在這個人群中展示這些數據——這些患者是高度難治性患者，他們之前接受過多達 4 種預防性治療均告失敗，而該人群的數據看起來非常強勁。所以這是一個差異化的資料集。而且我認為，還要記住，當醫生在處理患者的特殊拇指問題時，無論是不良反應還是缺乏療效，他們都必須在同一類藥物的不同藥物之間做出選擇。一般來說，如果醫生一開始使用了一種配體螯合抗體，那麼再使用另一種配體螯合抗體，與嘗試使用受體拮抗劑相比，意義就不大了。因此，我們希望，作為唯一的受體拮抗劑，該受體能夠為試圖治療這種極具挑戰性的疾病的醫生提供更多治療選擇。

And our next question is from the line of Carter Gould from UBS Equities.

下一個問題來自瑞銀證券的卡特古爾德。

I guess, a commercial question for Tony on XGEVA, hoping to get a little bit more detail on the uptick in the quarter. If you could maybe provide some rough detail on the size of the buy-in versus how much was driven by myeloma? Can you provide some anecdotes from physicians and institutions, but maybe some commentary on how access is going in this indication?

我想就 XGEVA 的業績成長向 Tony 提出一個商業問題，希望能更詳細地了解本季業績成長的情況。能否提供一些關於投資規模與多發性骨髓瘤驅動投資額之間大致情況的詳細資訊？您能否提供一些來自醫生和醫療機構的軼事，並就該適應症的准入情況發表一些評論？

Okay, Carter. Yes, it's a great indication to have to expand the label. We estimate there's about 100,000 multiple myeloma patients in the U.S. that potentially could benefit from the product. Because it's a Part B product, I don't see the prescriptions as tightly as I do with the Part D products. So we tend to look back about 6 to 8 weeks in arrears. It is clear that there's a large number of patients who could benefit from this. The feedback has been good. The buy-in probably accounts for about $30 million in the quarter, which we expect to burn off quite quickly. But everything we've heard to date has been positive.

好的，卡特。是的，這是一個很好的跡象，表明需要擴大標籤範圍。我們估計美國約有 10 萬名多發性骨髓瘤患者可能會從該產品中受益。因為這是 B 部分產品，所以我不會像對待 D 部分產品那樣嚴格審查處方。所以我們往往會回顧過去 6 到 8 週的事情。顯然，有很多患者可以從中受益。反饋良好。本季入股金額可能約為 3,000 萬美元，我們預計這筆錢會很快消耗掉。但我們目前聽到的都是正面的消息。

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

下一個問題來自摩根士丹利的馬修·哈里森。

I just wanted to ask a question on Parsabiv, if I could. I understand the financial and sort of growth prospects for the next year or 2 of all the product outside of the bundle. Maybe you could just talk to us about what happened with this product and how you think about potentially longer term growth driver once it gets added into the bundle and what the scenarios are for that?

如果可以的話，我想問一個關於 Parsabiv 的問題。我了解捆綁產品以外的所有產品在未來一兩年內的財務狀況和成長前景。或許您可以和我們談談這款產品的情況，以及您認為一旦它被添加到產品組合中，它可能會如何成為長期的成長驅動因素，以及有哪些可能的發展情景？

Matthew, tough to calculate that. As you know, the TDAPA will run for a minimum of 2 years. CMS will do a full evaluation of the benefit of the drug. We've looked at our head-to-head trial. We feel that is fairly beneficial from an efficacy perspective. We also believe, because of the IV line administration during dialysis, that adherence were improved. And by definition, the real world situation will deliver a higher level of value to both the patients and the dialysis units. And therefore, it's not an end all, it really is evaluating the benefit the drug brings and then how that is calculated into the future bundle going forward post TDAPA .

馬修，這很難計算。如您所知，TDAPA 將至少運行 2 年。CMS將對該藥物的益處進行全面評估。我們已經研究了我們的直接對比試驗。我們認為從療效角度來看，這相當有益。我們也認為，由於透析期間採用靜脈輸液，患者的依從性得到了改善。根據定義，現實世界的情況將為患者和透析中心帶來更高的價值。因此，這並不是最終結果，而是真正評估藥物的益處，以及如何在 TDAPA 之後將其納入未來的治療方案中。

And our next question is from the line of Kennen MacKay from RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的 Kennen MacKay。

Maybe another one for Tony. I was just wondering if you can elaborate, just what was going on with Aranesp surrounding the competition with some of the smaller providers? And then, on the long term guidance, wondering if you're accounting for (inaudible) inhibitors in the coming years here?

或許再給托尼一個。我只是想問一下，您能否詳細說明一下，Aranesp 與一些規模較小的供應商之間的競爭究竟是怎麼回事？那麼，關於長期業績指引，我想知道您是否考慮到了未來幾年可能出現的（聽不清楚）抑制劑問題？

Okay. So Aranesp, as you know, is bifurcated into a whole lot of pieces. More than half our business is outside the United States where the business continues to be fairly stable, other than foreign exchange. Inside the U.S., it is divided between the dialysis nephrology business, the hospital nephrology business and the oncology areas. Oncology has been declining for some time, so we see no change there. In the nephrology dialysis, there has been a movement from a competitor -- a long-acting competitor from FMC that has now moved into some of the IDOs and the MDOs and some of the decline you're seeing. We do have volume and shared contracts with a few of these people and we will continue to fight account by account. And then, on the nephrology hospital, there's a strange compare versus first quarter 2017, which included a large clinical trial purchase from a competitor.

好的。如你所知，阿拉內斯普分裂成了許多部分。我們超過一半的業務都在美國以外，除了外匯波動之外，這些地區的業務一直相當穩定。在美國，腎臟病業務分為透析腎臟病業務、醫院腎臟病業務和腫瘤科領域。腫瘤科的病例數已經下降了一段時間，所以我們認為這方面不會有任何變化。在腎臟透析領域，競爭對手——FMC 的一家長期競爭對手——已經進入了一些 IDO 和 MDO 市場，這也是你現在看到的一些下滑的原因。我們與其中一些人有業務量和共同合同，我們將繼續逐個客戶地爭取權益。然後，在腎臟病醫院方面，與 2017 年第一季相比，有一個奇怪的比較，其中包括從競爭對手那裡購買的一項大型臨床試驗。

And our next question is from the line of Ronny Gal from Bernstein.

我們的下一個問題來自伯恩斯坦的 Ronny Gal 的發言。

Tony, I'm afraid this one is for you as well around the PCSK9. As we think about the context you're trying to sign out with the payers, are you guys looking for open access, or are you looking to close out those account with a single award? Or is a competitor interested in doing that and you're following them? And second, you kind of mentioned the issue around how low does one needs to go with LDL-C. And I was wondering if you or Sean can comment on the JAMA article showing kind of like fading off the benefit when you start a patient below 100 LDL-C.

Tony，恐怕 PCSK9 的問題也跟你有關。當我們思考你們試圖與付款方達成的協議時，你們是希望實現開放獲取，還是希望透過一次性撥款來結束這些帳戶？或者，你的競爭對手也對此感興趣，而你正在效仿他們？其次，你剛才也提到了低密度脂蛋白膽固醇（LDL-C）需要降到多低的問題。我想請問您或肖恩能否就 JAMA 文章發表一些看法，該文章指出，當患者的 LDL-C 低於 100 時，治療效果似乎會逐漸減弱。

So I think we've always said that we would always want to have a situation where the physician has a choice on behalf of the patient. So I would always advocate for having an open formulary. We do talk consistently about looking for ways and means to have access for this high-risk patient population. There's about 3.4 million patients in the high-risk population. We think, a very, very small percentage, a single-digit penetration has been made into that population to date. And then, I'll let Sean talk about the scientific discussion around lowering LDL.

所以我認為我們一直都希望醫生能代表病人做出選擇。所以我始終主張實行開放式藥品目錄。我們一直在討論如何尋找方法和途徑，讓這部分高風險病患群體能夠獲得醫療服務。高危險群中約有 340 萬名患者。我們認為，迄今為止，只有非常非常小的比例，甚至只有個位數的滲透率進入了該族群。然後，我將讓肖恩談談關於降低低密度脂蛋白膽固醇的科學討論。

Yes. So I'm familiar with the JAMA article that you're referring to that was just published. It's a meta-analysis. I'd point you to the accompanying editorial which I thought was pretty good at outlining some of the likely confounding that occurred in that meta-analysis. The problem with these meta-analyses is when they go back in time, 20-plus years, and look at mortality, they're very confounded by the case fatality rates that occur when people are hospitalized in the studies or experience heart attack and stroke, for example. So if you go back to, for example, the 4S Study or Western Scotland studies, the case fatality rate for a heart attack back in those days was like 30%, now it's 4%. So you really end up with a very confounded analysis which says, "Well, Gee, when you start with a high LDL and you lower it kind of to a midrange, you get this big benefit on mortality." Well, that's just what they were doing back then because there were no statins and so people came in at very high LDL levels and they got reduced. And nowadays, they come in at much lower LDL levels and it's virtually impossible to demonstrate a statistically significant reduction in mortality, which has not happened in a long time in lipid-lowering trials. So I think that it's very confounded. I think the editorials speaks to most of that. And also just talks about just shouldn't we pay attention to the biology and our understanding holistically about how these products work and the data that emerged from all the studies that have happened in this field, whether they be with statins or products like azetamide or now the PCSK9 inhibitors. The overall clear picture is that no matter where your LDL starts, if you lower it substantially in a patient who's at high risk, you're going to get a very large risk reduction. It is true that if a patient starts at a high LDL, they have a higher risk because LDL is a risk factor. So in absolute terms, you get a little bit more benefit for treating patients who have higher LDLs. But the relative risk reduction appears to be consistent across trend and the highest quality data show a very clear picture of lower is better without any safety concern. So that's my comments on it.

是的。所以，我了解你提到的那篇剛剛發表在 JAMA 上的文章。這是一項薈萃分析。我建議您閱讀隨附的社論，我認為它很好地概述了該薈萃分析中可能出現的一些混淆因素。這些統合分析的問題在於，當它們回溯到 20 多年前，並查看死亡率時，它們會受到研究中住院患者或心臟病發作和中風等事件的病死率的嚴重干擾。例如，回顧 4S 研究或蘇格蘭西部研究，當時心臟病發作的病死率約為 30%，而現在是 4%。所以最終你會得到一個非常混亂的分析結果，那就是：「哎呀，當你的低密度脂蛋白膽固醇（LDL）水平很高，然後把它降到中等水平時，就能顯著降低死亡率。」 嗯，那隻是因為當​​時還沒有他汀類藥物，所以人們入院時的LDL水平非常高，然後才降低了他們的LDL水平。如今，他們的低密度脂蛋白膽固醇水平要低得多，幾乎不可能證明死亡率有統計學意義上的顯著降低，而降血脂試驗已經很久沒有出現這種情況了。所以我覺得很複雜。我認為社論已經闡述了大部分內容。而且，他還談到，我們是否應該關註生物學，全面了解這些產品是如何起作用的，以及該領域所有研究產生的數據，無論是他汀類藥物、氮雜卓胺類藥物還是現在的 PCSK9 抑制劑。整體而言，無論低密度脂蛋白膽固醇 (LDL) 的初始值是多少，如果大幅降低高風險患者的 LDL 水平，就能大幅降低風險。如果患者的低密度脂蛋白膽固醇（LDL）水平較高，那麼他們的風險確實會更高，因為低密度脂蛋白膽固醇本身就是一個風險因素。因此，從絕對意義上講，治療 LDL 水平較高的患者會獲得更多益處。但相對風險降低似乎在趨勢上保持一致，最高品質的數據非常清楚地表明，風險越低越好，而且沒有任何安全隱患。以上就是我的看法。

Our next question is from the line of Salim Syed from Mizuho Securities.

我們的下一個問題來自瑞穗證券的 Salim Syed。

I just had one on Repatha, so the AHA/ACC treatment guideline, some people expected to come out this year at the AHA conference in 2018, that's November, I believe. Do you have that same view? And then, how do you expect -- what do you expect to come out of that in terms of practical incremental revenue opportunity for Repatha If they lower the target LDL levels?

我剛剛參加了 Repatha 的會議，所以 AHA/ACC 治療指南，有些人預計會在今年的 AHA 會議上發布，也就是 2018 年 11 月，我相信。你也有同樣的看法嗎？那麼，如果降低目標 LDL 水平，您預期 Repatha 能從中獲得哪些實際的增量收入機會？

I'd just comment that I think you're right, that the sort of general expectation is that they'll do around the AHA timeframe. And at this point, one assumes that they're not going to be waiting around for another data set that I can think of in lipid-lowering land. So I think it's pretty likely that they'll come out. And I think that if you look at the pathway update that was done some months ago, it likely is kind of indicative directionally of where they're likely to go as the data has accumulated.

我只想說，我認為你是對的，普遍的預期是他們會在 AHA 的時間範圍內完成。因此，可以推斷，他們不會再等待降血脂領域出現另一組數據了。所以我認為他們很可能會出來。我認為，如果你看看幾個月前進行的路徑更新，它很可能在某種程度上指示了隨著數據積累，他們可能會朝著哪個方向發展。

And then, from a revenue perspective, I would imagine it would be very difficult for payers to have utilization management criteria that differ to the guidelines that are published by the AHA and the ACC.

從收入的角度來看，我認為支付方很難制定與美國心臟協會 (AHA) 和美國心臟病學會 (ACC) 發布的指南不同的利用管理標準。

And our next question is from James Birchenough from Wells Fargo Securities.

下一個問題來自富國證券的詹姆斯·伯奇諾夫。

This is Nick in for Jim. Just going back to CAR T, I wonder if you could comment on Amgen's investment in this space with respect to developing commercially ready as opposed to academic components such as (inaudible), closed manufacturing systems. And then, for solid tumors, many assume that to get success with CAR T, you'll need to take a combination approach. Do you share that view?

這是尼克代替吉姆上場。回到 CAR-T 療法，我想知道您能否就安進公司在該領域的投資發表評論，特別是關於開發商業化組件（而非學術組件）方面，例如（聽不清楚）封閉式製造系統。此外，對於實體瘤，許多人認為，要使 CAR-T 療法成功，需要採取聯合療法。你同意這種觀點嗎？

Well, let me answer the second question first. I think that -- I believe that in most disease settings, with -- whether you're dealing with a CAR T or the bispecific T-cell engaging type technology, particularly in solid tumor settings, but even in some settings such as lymphoma, people will hypothesize that there could be additive or synergistic effects between checkpoint inhibition and the use of these kind of targeted antigen-focused approaches. So I think time will tell, but you can expect to see many of these agents develop where an arm in the clinical trial will be to combine the product with a checkpoint inhibitor in addition to looking at its activity alone. I hope that answer that part of the question. And Tony, I think, there was a component in the question having to do with kind of the more of the commercial landscape. These are Phase I. We're just getting ready to start enrolling the first patient in our first CAR T program in Phase I. So we're certainly working with Tony's organization but it's very early stage at this point.

好，我先回答第二個問題。我認為——我相信在大多數疾病情況下，無論是使用 CAR T 還是雙特異性 T 細胞接合技術，尤其是在實體瘤情況下，甚至在淋巴瘤等某些情況下，人們都會假設檢查點抑制和使用這類靶向抗原的方法之間可能存在疊加或協同效應。所以我認為時間會證明一切，但可以預見的是，許多此類藥物的研發將會在臨床試驗中增加一個試驗組，將該產品與檢查點抑制劑聯合使用，同時檢視其單獨活性。我希望這能解答這個問題的一部分。東尼，我認為這個問題還包含著與商業環境有關的因素。這是第一階段。我們正準備開始招募首位病患參與我們首個CAR-T療法計畫的第一階段。所以我們當然在與東尼的機構合作，但目前還處於非常早期的階段。

And Nick, I'm not sure as well as you're referring to manufacturing, but anyway, you can follow up with Arvind and his team who are here for a while this evening if we didn't get to the full breadth of your question. Anyway, let me just wrap up by thanking you all for joining the call. As you can see, we're off to a good start here at the first quarter of 2018. We think we're in a strong position heading into the balance of the year and we're feeling confident about the long-term outlook for growth of the company. So we look forward to joining with you again here after the second quarter. Thank you.

尼克，我不確定你是不是也提到了製造業，不過，如果你的問題沒有得到充分解答，你可以聯繫阿文德和他的團隊，他們今晚會在這裡待一段時間。總之，最後感謝各位參加這次通話。如您所見，2018 年第一季我們開局良好。我們認為，進入今年剩餘時間，我們處於有利地位，並且對公司的長期成長前景充滿信心。所以我們期待在第二季結束後再次與大家相聚。謝謝。

Great. Thanks, everybody. Thanks, Ian.

偉大的。謝謝大家。謝謝你，伊恩。

Ladies and gentlemen, this does conclude Amgen's first quarter 2018 financial results conference call. We thank you greatly for your participation. You may now disconnect.

女士們、先生們，安進公司2018年第一季財務業績電話會議到此結束。非常感謝您的參與。您現在可以斷開連線了。