美國安進 (AMGN) 2019 Q2 法說會逐字稿

My name is Ian, and I will be your conference facilitator today for Amgen's Second Quarter 2019 Financial Results Conference Call. (Operator Instructions) I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

我叫伊恩，今天我將擔任安進公司 2019 年第二季財務業績電話會議的主持人。（操作員指示）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. Thanks, Ian. Good afternoon, everybody, and thanks for joining us to discuss our second quarter results. As I've done in the past, I would like to extend a special welcome to those who are new in their coverage of our company. And this quarter, it's Mohit Bansal of Citi. Welcome, Mohit.

好的。謝謝你，伊恩。各位下午好，感謝各位參加我們第二季業績討論會。和以往一樣，我要特別歡迎那些首次報道我們公司的朋友們。本季度，花旗銀行的莫希特·班薩爾 (Mohit Bansal) 當選。歡迎你，莫希特。

I think our performance in the second quarter can be best characterized as continued execution while staying focused on sustained long-term growth. Leading the discussion today will be our Chairman and CEO, Bob Bradway, who will provide a strategic perspective on our business, particularly within the backdrop of a fast-changing business environment. Our CFO, David Meline, will then review our financial results for the second quarter and provide updated guidance. Our Head of Global Commercial Operations, Murdo Gordon, will review our product performance; followed by our Head of R&D, Dave Reese, who will provide a pipeline update.

我認為我們第二季的表現可以最好地概括為：在保持持續長期成長的同時，繼續有效執行各項計畫。今天主持討論的將是我們董事長兼首席執行官鮑勃·布拉德韋，他將從戰略角度闡述我們的業務，尤其是在快速變化的商業環境背景下。我們的財務長大衛梅林隨後將審查第二季度的財務業績，並提供更新後的業績指引。我們的全球商業營運主管 Murdo Gordon 將回顧我們的產品表現；隨後，我們的研發主管 Dave Reese 將提供產品線最新進展。

As we have done in the past, we will use slides to guide our discussion today, and you should have received a link separately. Just a reminder, that we'll use non-GAAP financial measures in today's presentation, and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

和以往一樣，我們今天將使用幻燈片來引導討論，您應該已經單獨收到連結。提醒各位，我們今天的演示將使用非GAAP財務指標，其中一些陳述屬於前瞻性陳述。我們的 10-K 及後續文件列出了可能導致我們實際業績與預期有重大差異的因素。

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

那麼，接下來我將把電話交給鮑伯。鮑伯？

Okay. Thank you, Arvind, and I thank all of you for joining us. Halfway through the year, we're making clear progress in delivering on our strategy for long-term growth, and at the core of this strategy, of course, are innovative first-in-class medicines addressing serious diseases globally. While our strategy embraces medicines like BLINCYTO, which is our bispecific T-cell engager, for example, with its large effect size in a specialty market, our strategy also explicitly addresses diseases where the unmet need is measured in many millions of patients. Over time, we think this balance is going to be essential and expect that increasing global price pressures will highlight the importance of products that can deliver sustained growth through volume gains rather than annual price increases.

好的。謝謝你，Arvind，也謝謝各位的到來。今年已過半，我們在實現長期成長策略方面取得了明顯進展，而這項策略的核心當然是針對全球嚴重疾病的創新一流藥物。雖然我們的策略涵蓋了像 BLINCYTO 這樣的藥物（例如，我們的雙特異性 T 細胞銜接器），它在專業市場中具有顯著的效果，但我們的策略也明確針對數百萬患者未滿足需求的疾病。我們認為，隨著時間的推移，這種平衡將至關重要，並且預計不斷增加的全球價格壓力將凸顯那些能夠透過銷售成長而非年度價格上漲來實現持續成長的產品的重要性。

Prolia is a great example of this. Now more than 10 years after launch, it once again posted double-digit volume growth this quarter and its long-term prospects remain bright as there are still millions of women at high risk of fracture who are not yet on a preventative therapy like Prolia.

Prolia 就是一個很好的例子。在上市 10 多年後，該產品本季再次實現了兩位數的銷售成長，其長期前景依然光明，因為仍有數百萬骨折高風險女性尚未接受像 Prolia 這樣的預防性治療。

The recent launch of EVENITY will enable us to extend our industry leadership in bone health and bring more options to positions seeking to address the global epidemic of osteoporosis. More generally, Prolia points the way for other products in our portfolio, like Repatha, Aimovig and potentially, tezepelumab.

EVENITY 的近期推出將使我們能夠擴大在骨骼健康領域的行業領先地位，並為尋求解決全球骨質疏鬆症流行病的職位提供更多選擇。更廣泛地說，Prolia 為我們產品組合中的其他產品指明了方向，例如 Repatha、Aimovig 以及潛在的 tezepelumab。

Let me touch briefly on Repatha. I think all of us know that cardiovascular disease is a leading health problem globally. The numbers are so large that some seem to have been numbed or lulled into a sense of complacency about them, but that's changing, partly because after decades of decreasing morbidity and mortality, the trends have worsened and the death rate from heart attack and stroke is now actually increasing in the U.S. and internationally. We know one of the reasons for this is that LDL levels are too high in too many people. We believe Repatha offers a solution to that problem for many people. And given demographics, health systems cannot continue to ignore the meaningful uptick in cardiovascular events and deaths. It will only get worse without more widespread use of innovative medicines that address atherosclerotic disease. We see increasing recognition of this here and abroad, and of course, we're seeking to do our part including taking actions as we did last year in a competitive context to lower the out-of-pocket costs for patients to use this therapy. We will continue to advocate for high-risk patients and those who recognize the urgency of getting in front of the growing problem of heart disease in our society.

讓我簡單談談瑞百達（Repatha）。我想我們都知道，心血管疾病是全球主要的健康議題之一。這些數字如此龐大，以至於有些人似乎已經麻木或麻木，產生了一種自滿情緒，但這種情況正在改變，部分原因是，在經歷了數十年的發病率和死亡率下降之後，趨勢惡化了，心臟病和中風的死亡率現在實際上在美國和國際上都在上升。我們知道其中一個原因是許多人的低密度脂蛋白膽固醇（LDL）水平過高。我們相信，Repatha 可以為許多人解決這個問題。鑑於人口結構的變化，醫療系統不能繼續忽視心血管事件和死亡人數的顯著上升。如果不能更廣泛地使用治療動脈粥狀硬化疾病的創新藥物，情況只會變得更糟。我們看到國內外對此的認識不斷提高，當然，我們也在努力盡自己的一份力，包括像去年在競爭環境下那樣採取行動，降低患者使用這種療法的自付費用。我們將繼續為高風險患者以及那些認識到應對我們社會日益嚴重的心臟病問題緊迫性的人們發聲。

With Aimovig, our first-in-class CGRP medicine, we're transforming the treatment of migraine. Like Prolia and Repatha, it addresses a chronic debilitating disease afflicting millions of people worldwide. We recently presented important new data at the American Headache Society meeting, demonstrating that Aimovig's efficacy improves over time. We expect this medicine to be of increasing importance to migraine sufferers and a key growth driver for years to come.

憑藉我們首創的 CGRP 藥物 Aimovig，我們正在改變偏頭痛的治療方式。就像 Prolia 和 Repatha 一樣，它針對的是一種困擾著全世界數百萬人的慢性衰弱性疾病。我們最近在美國頭痛協會會議上公佈了重要的新數據，證明 Aimovig 的療效會隨著時間的推移而提高。我們預計這種藥物對偏頭痛患者的重要性將日益增加，並在未來幾年成為關鍵的成長驅動力。

Turning to our growing hematology and oncology products, we posted 10% growth for KYPROLIS, XGEVA, Nplate, Vectibix, IMLYGIC and BLINCYTO, which together are annualizing at more than $5 billion revenues. We see more growth ahead from these medicines. Our confidence in BLINCYTO was bolstered by the compelling 5-year survival data we reported in MRD-positive ALL patients. Based on this and other data emerging from our BiTE platform, our confidence in that therapy is high.

再來看我們不斷成長的血液學和腫瘤學產品，KYPROLIS、XGEVA、Nplate、Vectibix、IMLYGIC 和 BLINCYTO 的成長率均為 10%，這些產品加起來的年收入超過 50 億美元。我們預計這些藥物未來還會有更大的成長空間。我們在 MRD 陽性 ALL 患者中報告的令人信服的 5 年生存數據增強了我們對 BLINCYTO 的信心。基於此以及我們 BiTE 平台產生的其他數據，我們對這種療法充滿信心。

The demand for innovative medicines is growing rapidly outside the U.S. and the larger European markets. Looking at demographic trends, we expect this to continue for some time. That's why we've made international expansion an important part of our strategy. We're beginning to see measurable returns from our efforts. Internationally, our volumes were up 18% in the second quarter. And if you look at markets where we were historically absent, like Japan and China, you can also see the benefits of our strategy coming to light. Japan was the first country to approve EVENITY globally and was our first market launch. We're very pleased with the uptake there. Similarly, BLINCYTO is performing well in Japan. And overall, we're encouraged by the performance of our Amgen-Astellas biopharma partnership.

美國和歐洲等較大市場以外的地區對創新藥物的需求正在迅速增長。從人口趨勢來看，我們預期這種情況還會持續一段時間。這就是為什麼我們將國際擴張作為我們策略的重要組成部分。我們開始看到努力取得可衡量的回報。國際市場方面，我們第二季的銷售量成長了 18%。如果你看看我們過去從未涉足的市場，例如日本和中國，你也會發現我們策略帶來的好處正在顯現。日本是全球第一個批准 EVENITY 的國家，也是我們第一個上市的國家。我們對那裡的銷售情況非常滿意。同樣，BLINCYTO在日本也表現出色。總的來說，我們對安進-安斯泰來生物製藥合作的成果感到鼓舞。

China, though it is still early days for Amgen, represents another attractive long-term growth opportunity for us, and we're encouraged by the progress in advancing our medicines for that market with the early launches of Repatha and XGEVA.

儘管安進進入中國市場仍處於起步階段，但中國市場代表著另一個極具吸引力的長期成長機會。隨著 Repatha 和 XGEVA 的早期上市，我們在推動中國市場的藥物研發方面取得了進展，這讓我們倍感鼓舞。

At Amgen, whenever we talk about delivering in the long term, we're always clear that you only get to deliver in the long term if you succeed in the short and medium term. Our results in Q2 show that we're doing that. With pressure following patent expirations across a number of our products, we maintained strong operating margins, attractive returns on our capital and ongoing steady return of cash to our shareholders in dividends and buybacks. And our stewardship of the business is also reflected in our competitive market share performance across our mature and recently launched portfolio of products. We'll be staying closely focused on execution and productivity as we seek to invest in the long-term opportunities that will enable us to reestablish our long-term track record of growth.

在安進，每當我們談到長期交付時，我們總是明確指出，只有在短期和中期內取得成功，才能實現長期交付。第二季的業績表明，我們正在朝著這個方向努力。儘管我們多款產品的專利到期帶來了壓力，但我們仍保持了強勁的營業利潤率、可觀的資本回報，並透過股息和股票回購持續穩定地向股東返還現金。我們對業務的管理也體現在我們成熟產品和新推出的產品組合中具有競爭力的市佔率表現。我們將繼續密切關注執行力和生產力，同時尋求投資長期機遇，以期重新建立我們長期成長的良好記錄。

Our long-term opportunities include many novel first-in-class therapies across all phases of our pipeline. One of these, of course, is AMG 510, our KRAS G12C inhibitor, which has generated significant interest and continues to move very rapidly through the clinic.

我們的長期機會包括我們研發管線各階段的許多創新首創療法。當然，其中之一就是我們的 KRAS G12C 抑制劑 AMG 510，它引起了人們的極大興趣，並且正在迅速推進臨床試驗。

We anticipate many important data readouts across the portfolio over the next 12 months as we advance therapies against cancer, cardiovascular disease, respiratory disease and other inflammatory disorders.

我們預計在接下來的 12 個月裡，隨著我們推進癌症、心血管疾病、呼吸系統疾病和其他發炎性疾病的療法，我們將公佈產品組合中的許多重要數據。

Additionally, I'd like to note, in Q2, we bolstered our industry-leading human genetics capability with our collaboration with Intermountain Healthcare, and we added a new important research platform through our acquisition of Nuevolution. Dave Reese will share more information about our pipeline as well as these collaborations when he talks about research and development in a moment.

此外，我想指出，在第二季度，我們透過與 Intermountain Healthcare 的合作，增強了我們行業領先的人類遺傳學能力，並透過收購 Nuevolution 增加了一個新的重要研究平台。Dave Reese 稍後在談到研發時，會分享更多關於我們產品線以及這些合作的資訊。

Now let me share a couple of thoughts with you on the drug pricing debate here in the United States, noting first that the environment remains fluid. The administration and Congress, as you know, are considering various proposals, but it's too early to speculate on whether there will be any changes and if there are any, what the impact of them might be given that the process is still playing out.

現在我想和大家分享我對美國藥品定價辯論的一些想法，首先要指出的是，目前的情況仍然瞬息萬變。如您所知，政府和國會正在考慮各種提案，但現在就推測是否會有任何變化，以及如果有變化會產生什麼影響還為時過早，因為這個過程仍在進行中。

I know the Senate Finance Committee bill, in particular, has attracted attention and is an important example of this focus, but many provisions in the bill remain controversial and will likely be modified before advancing.

我知道參議院財政委員會的法案尤其引起了關注，也是這種關注的重要例證，但該法案中的許多條款仍然存在爭議，在推進之前可能會進行修改。

Amgen's particularly focused on ensuring that patients benefit more directly from any savings that are generated by legislation that's advancing, and we think that, in general, more can be done to help patients who bear, in present anyway, a disproportionate share of drug costs through out-of-pocket expenses. And we'll continue to engage in a thoughtful dialogue with the administration and Congress on drug pricing issues, and we're committed to find ways to drive change that still promotes innovation and respects our market-based initiatives that will help address financial and societal burden of some of the world's most serious diseases.

安進尤其關注確保患者能夠更直接地從正在推進的立法所帶來的任何節省中受益，我們認為，總的來說，還可以做更多的工作來幫助那些目前通過自付費用承擔不成比例的藥品費用的患者。我們將繼續與政府和國會就藥品定價問題進行深入對話，並致力於尋找推動變革的方法，這些變革既能促進創新，又能尊重我們以市場為基礎的舉措，從而幫助解決世界上一些最嚴重疾病帶來的經濟和社會負擔。

One solution to alleviate some of the financial and societal burden is through the introduction of biosimilars. Last year, we launched our first biosimilars in Europe, KANJINTI, our biosimilar to Herceptin, and AMGEVITA, our biosimilar to Humira. A couple of weeks ago, we launched KANJINTI and MVASI, our biosimilar to Avastin, in the U.S. We believe biosimilars will play an increasingly important role in helping to address issues of access and affordability in the U.S. and around the world, and we're excited to be a leader in this emerging space.

緩解部分經濟和社會負擔的解決方案是引入生物相似藥。去年，我們在歐洲推出了首批生物相似藥，分別是赫賽汀的生物相似藥 KANJINTI 和修美樂的生物相似藥 AMGEVITA。幾週前，我們在美國推出了 KANJINTI 和 MVASI，它們是 Avastin 的生物相似藥。我們相信，生物相似藥將在幫助解決美國乃至全世界的藥物可及性和可負擔性問題方面發揮越來越重要的作用，我們很高興能夠成為這一新興領域的領導者。

I'll end by highlighting that we continue to generate strong cash flow, continue to invest in R&D aggressively and to prudently return excess capital to shareholders. We're in a strong position to grow our business organically and externally, but we'll remain disciplined in business development opportunities.

最後我想強調的是，我們持續產生強勁的現金流，持續大力投資研發，並謹慎地將多餘的資本回饋給股東。我們有能力透過自身發展和外部拓展實現業務成長，但我們會繼續謹慎對待業務拓展機會。

As I stated earlier, Amgen is executing well, and we remain excited about our long-term outlook. I'll turn the call over now to David Meline, who will review our financial performance. David?

正如我之前所說，安進公司運作良好，我們對公司的長期前景依然充滿信心。現在我將把電話交給大衛梅林，他將回顧我們的財務表現。大衛？

Okay. Thanks, Bob. Overall, we are pleased with our strong performance in the second quarter as investments in support of our newer products delivered volume-driven growth and year-over-year EPS growth in the second quarter.

好的。謝謝你，鮑伯。總體而言，我們對第二季的強勁業績感到滿意，因為對新產品的投資帶來了銷售成長和同比每股收益成長。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $5.9 billion in the second quarter declined 3% year-over-year. Worldwide product sales at $5.6 billion in the second quarter declined 2% year-over-year as growth for our newer products was slightly outpaced by declines in our mature brands, impacted by increasing competition due to patent expirations. Other revenues at $297 million declined $83 million year-over-year due to a prior year milestone payment. We continue to expect full year other revenues of about $1.1 billion.

接下來請看投影片第6頁的財務表現。第二季全球營收為 59 億美元，年減 3%。第二季全球產品銷售額為 56 億美元，年減 2%，因為新產品的成長略低於成熟品牌的下滑，而成熟品牌的下滑又受到專利到期導致的競爭加劇的影響。其他收入為 2.97 億美元，年比減少 8,300 萬美元，原因是上一年的里程碑付款。我們仍然預計全年其他收入約為 11 億美元。

Non-GAAP operating income was $3 billion and declined 5% from prior year. Non-GAAP operating margin was 53% from the second quarter. As in prior years, our operating margin is expected to be lower in the second half of the year, driven by the timing of expenses.

非GAAP營業收入為30億美元，較上年下降5%。非GAAP營業利潤率為53%，與第二季相比有所下降。與往年一樣，受費用發生時間的影響，預計下半年我們的營業利潤率將會下降。

Consistent with our plans, second quarter non-GAAP operating expenses decreased 1% year-over-year as we continued to make incremental investments to drive growth and maximize shareholder value while benefiting from our permanent productivity capability. As communicated earlier this year, we continue to expect full year 2019 operating expense on an absolute basis to be flat versus 2018.

與我們的計劃一致，第二季度非GAAP營運費用年減1%，因為我們繼續進行增量投資以推動成長並最大限度地提高股東價值，同時受益於我們永久的生產力能力。正如今年稍早所溝通的那樣，我們仍然預計 2019 年全年營運支出絕對值將與 2018 年持平。

On a non-GAAP basis, cost of sales as a percent of product sales was relatively flat year-over-year at 13.2%. We anticipate 2019 full year cost of sales on an absolute basis to be flat to slightly up depending on volume and continuing to reflect our industry-leading performance.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比與去年同期基本持平，為13.2%。我們預計 2019 年全年銷售成本絕對值將與去年持平或略有上升，具體取決於銷量，並將繼續反映我們行業領先的業績。

Second quarter research and development expenses of $906 million were 7% higher year-over-year due to increased investments in support of our early- and late-stage oncology programs. Research and development expense as a percent of product sales was 16.3%. For the full year, we continue to expect R&D spend trajectory on an absolute basis to increase in single-digit percentage terms as our pipeline advances.

由於增加了對早期和晚期腫瘤項目的投資，第二季研發支出為 9.06 億美元，較去年同期成長 7%。研發費用佔產品銷售額的16.3%。預計全年研發支出將隨著產品線的推進而以個位數百分比成長。

SG&A expenses decreased 6% on a year-over-year basis primarily driven by reduced discretionary general and administrative expenses and cost management discipline. We expect that for the full year, SG&A expense on an absolute basis will decline year-over-year.

銷售、一般及行政費用較去年同期下降 6%，主要原因是可自由支配的一般及行政費用減少以及成本管理紀律。我們預計全年銷售、一般及行政費用絕對值將較去年同期下降。

Other income and expenses were a net $114 million expense in Q2. This is favorable by $71 million on a year-over-year basis primarily driven by prior year investment portfolio liquidation losses as well as continued good performance for our Amgen Ventures portfolio. The non-GAAP tax rate was 15.3% for the quarter, a 1.1-point increase versus the second quarter of 2018 primarily due to a prior year tax benefit associated with intercompany sales under U.S. corporate tax reform. Non-GAAP net income decreased 4%, and non-GAAP earnings per share increased 4% year-over-year for the second quarter to $3.97 per share.

第二季其他收入和支出淨額為 1.14 億美元。與前一年相比，這帶來了 7,100 萬美元的收益，主要得益於上一年投資組合清算損失以及安進創投投資組合的持續良好表現。本季非GAAP稅率為15.3%，較2018年第二季增加1.1個百分點，主要原因是美國企業稅制改革下與公司間銷售相關的上一年稅收優惠。第二季非GAAP淨利下降4%，非GAAP每股盈餘較去年同期成長4%至每股3.97美元。

Turning next to cash flow and the balance sheet on Page 7. Free cash flow for the second quarter of 2019 was $1.3 billion. This was lower than second quarter last year as this year's result was negatively impacted by an advanced tax deposit payment. Consistent with our principles, we continue to provide significant cash returns to shareholders. In Q2, we deployed $2.3 billion to repurchase 13.1 million shares at an average price of $180 per shares. We plan to repurchase an incremental 1 billion to 2 billion of our shares in Q3. Additionally, our second quarter dividend increased to $1.45 per share, an increase of 10% over last year.

接下來請看第 7 頁的現金流量表和資產負債表。 2019 年第二季的自由現金流為 13 億美元。由於今年的業績受到提前繳稅的負面影響，因此低於去年第二季的水平。秉承我們的原則，我們將繼續為股東提供豐厚的現金回報。第二季度，我們投入 23 億美元以每股 180 美元的平均價格回購了 1,310 萬股股票。我們計劃在第三季額外回購 10 億至 20 億股股票。此外，我們第二季的股息增加到每股 1.45 美元，比去年增長了 10%。

Cash and investments totaled $21.8 billion, a decrease of approximately $7.6 billion from the second quarter of last year primarily due to share repurchases and debt repayments. Our debt balance stands at $30.6 billion as of June 30, a reduction of approximately $3.9 billion from a year ago as we continue to pay down our debt as it matures.

現金及投資總額為 218 億美元，較去年第二季減少約 76 億美元，主因是股票回購和債務償還。截至 6 月 30 日，我們的債務餘額為 306 億美元，比一年前減少了約 39 億美元，因為我們將繼續償還到期債務。

Turning to the outlook for the business for 2019 on Page 8. We remain on track with our plans to continue to invest to advance our pipeline, including our oncology programs, build out our global presence and drive long-term volume growth while delivering solid business performance. Today, we are revising our 2019 guidance, which reflects our solid Q2 performance and the outlook for the second half of the year. Our revised revenue guidance is $22.4 billion to $22.9 billion versus previous guidance of $22.0 billion to $22.9 billion. This continues to reflect the range of evolving competitive dynamics associated with Neulasta and other legacy products.

請參閱第 8 頁，以了解 2019 年的業務展望。我們將繼續按計劃投資，推動我們的產品線，包括我們的腫瘤項目，擴大我們的全球影響力，並在實現穩健業務表現的同時，推動長期銷售成長。今天，我們修訂了 2019 年的業績預期，這反映了我們第二季穩健的業績以及對下半年的展望。我們修訂後的營收預期為 224 億美元至 229 億美元，而先前的預期為 220 億美元至 229 億美元。這繼續反映了與 Neulasta 和其他傳統產品相關的不斷變化的競爭動態。

With regard to our non-GAAP earnings per share guidance, we are revising the outlook to $13.75 to $14.30 a share versus previous guidance of $13.25 to $14.30. Further, we are maintaining our non-GAAP tax rate guidance of 14% to 15%. We continue to expect capital expenditures of approximately $700 million this year.

關於我們的非GAAP每股盈餘預期，我們將預期從先前的每股13.25美元至14.30美元調整為每股13.75美元至14.30美元。此外，我們維持非GAAP稅率預期在14%至15%之間。我們預計今年的資本支出仍約為7億美元。

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

財務更新到此結束。現在我把電話轉給默多。

Thanks, David, and good afternoon, everyone. You'll find product sales information starting on Slide 10.

謝謝你，大衛，大家下午好。從第 10 頁開始，您將看到產品銷售資訊。

In the second quarter of 2019, we continued to grow volumes across our newer portfolio while competing effectively with our more mature brands.

2019 年第二季度，我們持續擴大新產品組合的銷售量，同時有效地與更成熟的品牌競爭。

Moving to second quarter results. Let me start with Repatha on Slide 12. Q2 sales grew by 3% year-over-year as we continue to hold leading share of the PCSK9 class in this competitive market. Worldwide unit growth was 59% year-over-year, with 66% unit growth in the United States. In the first half of the year, over 50,000 new patients were prescribed Repatha in the U.S., which was close to a 55% increase versus the same period last year. The PCSK9 class has shown steady quarter-over-quarter growth, which we expect to continue throughout the second half of 2019 as we continue to make it our priority to improve access and affordability for patients.

接下來是第二季業績報告。讓我們從第 12 張投影片上的 Repatha 開始。第二季銷售額年增 3%，我們繼續在這個競爭激烈的市場中保持 PCSK9 類藥物的領先份額。全球銷量較去年同期成長 59%，其中美國銷量較去年同期成長 66%。今年上半年，美國有超過 5 萬名新患者被處方了 Repatha，與去年同期相比增加了近 55%。PCSK9 類藥物已呈現穩定的季度環比增長，我們預計這一增長勢頭將在 2019 年下半年繼續保持，因為我們將繼續把提高患者的用藥可及性和可負擔性作為我們的首要任務。

For Medicare patients, our 60% list price reduction materially improves affordability, and key to that patient affordability is access to Repatha at a low fixed co-pay tier. And while the lower list price version is now available to approximately 70% of seniors, we continue to be disappointed that payers have restricted low fixed co-pay coverage to 7% of Medicare patients. So as we go through the bidding cycle for 2020, we're very focused on improving this number.

對於 Medicare 患者而言，我們 60% 的標價降低顯著提高了患者的負擔能力，而患者負擔能力的關鍵在於能夠以較低的固定共付額獲得 Repatha。雖然現在大約 70% 的老年人可以享受到價格較低的版本，但我們仍然感到失望的是，支付方將低固定共付額的保險覆蓋範圍限制在 7% 的醫療保險患者中。因此，在 2020 年的競標週期中，我們非常注重提高這個數字。

Further on the commercial access front, we've recently obtained coverage at ESI which will help to expand access to close to 22 million patients. Recently, a study published in circulation demonstrated that high-risk individuals had a 16% increased risk of a cardiovascular event during the 11.5-month study period when their PCSK9 treatment was rejected by their insurance plan. The findings reinforce the need for continued engagement from all stakeholders, from health care professionals, to payers, to plans and to government agencies to improve access and patient affordability so that patients who need Repatha can get Repatha.

在商業准入方面，我們最近獲得了 ESI 的承保，這將有助於擴大近 2,200 萬名患者的承保範圍。最近，《循環》雜誌發表的一項研究表明，在 11.5 個月的研究期間，如果高風險族群的 PCSK9 治療被保險計劃拒絕，則他們發生心血管事件的風險會增加 16%。研究結果強調了所有利害關係人（從醫療保健專業人員到支付方、保險計劃和政府機構）持續參與的必要性，以改善藥物獲取和患者負擔能力，從而使需要 Repatha 的患者能夠獲得 Repatha。

With regard to pricing, the blended net price for Repatha in the U.S. declined in Q2 2019 versus the previous year due to contracts that took effect last July and the introduction of the lower list price SKU last October. Sequentially, net selling price was roughly flat. We're committed to driving adoption of the lower list price SKU and our current plan is to discontinue the original list price SKU in the beginning of 2020. With these actions and our efforts to open up access for Medicare patients at a low fixed co-pay, we expect that we will see a positive impact on volume and reported net sales growth over the long term.

就定價而言，由於去年 7 月生效的合約以及去年 10 月推出的較低標價 SKU，Repatha 在美國的 2019 年第二季綜合淨價較上年同期有所下降。從環比來看，淨售價基本上持平。我們致力於推動採用較低標價的 SKU，目前的計劃是在 2020 年初停售原標價 SKU。透過這些措施以及我們為醫療保險患者提供低固定自付費用就醫途徑的努力，我們預計從長遠來看，銷售和報告的淨銷售成長將受到正面影響。

Next, on to Prolia on Slide 13. Prolia continued its strong performance, with sales increasing 14% year-over-year, driven by 15% volume growth. Given the seasonality, quarters 2 and 4 delivered higher sales versus quarters 1 and 3. We continued to increase our investments in Prolia to drive penetration in this undertreated population and have seen double-digit year-over-year new patient growth in the U.S. Along with EVENITY, our innovative bone-building therapy, we're focused on addressing this global epidemic and increasing diagnosis and treatment for postmenopausal osteoporosis patients. EVENITY has convenient once-monthly physician-administered dosing for 12 months and strengthens Amgen's leading position in bone health. Through our joint venture with Astellas, we launched in Japan and in March, sold $25 million in Q2. The U.S. launch, in partnership with UCB, commenced in April and early feedback has been positive.

接下來，請看第 13 張投影片上的 Prolia。Prolia 持續保持強勁的業績，銷售額年增 14%，其中銷量成長 15%。考慮到季節性因素，第二季和第四季的銷售額高於第一季和第三季。我們持續增加對Prolia的投資，以提高該藥物在這一治療不足人群中的滲透率，並在美國實現了兩位數的同比增長。結合我們創新的骨骼重建療法EVENITY，我們致力於應對這場全球性流行病，並提高停經後骨質疏鬆症患者的診斷和治療率。EVENITY 提供便利的每月一次醫生給藥方案，療程為 12 個月，鞏固了安進在骨骼健康領域的領先地位。透過與安斯泰來製藥的合資企業，我們在日本推出了產品，並在 3 月實現了第二季 2500 萬美元的銷售額。該產品與 UCB 合作，於 4 月在美國上市，早期反饋積極。

Now on to Aimovig on Slide 15. Versus Q1, sales increased 41%. We hold the leading share of the CGRP market and continue to see improvement in our conversion of free-to-paid patients exiting Q2 at 74% paid. That increase in the percentage of paid volume was a significant driver of quarter-over-quarter sales growth. Penetration in the overall market is currently low considering 4 million migraine patients in the U.S. are eligible for CGRP treatment. However, we remain optimistic as 7,000 patients a week start a CGRP therapy, and to date, 225,000 patients have been prescribed Aimovig, with 1 million prescriptions filled. Additionally, the number of prescribers is consistently increasing as 27,000 physicians have now prescribed Aimovig since launch, with close to 10,000 primary care prescribers among them. We expect net price to remain relatively stable going forward as most patients have converted from free-to-paid and an increasing percentage of patients are covered under discounted contracts versus paying full list price.

接下來請看第15張投影片，內容是Aimovig。與第一季相比，銷售額成長了 41%。我們在 CGRP 市場佔據領先份額，並且我們不斷提高免費患者向付費患者的轉換率，第二季末付費患者比例達到 74%。付費銷售佔比的提高是季度環比銷售額成長的重要驅動因素。考慮到美國有 400 萬名偏頭痛患者符合 CGRP 治療的條件，目前該療法在整體市場的滲透率較低。不過，我們仍然保持樂觀，因為每周有 7,000 名患者開始接受 CGRP 治療，迄今為止，已有 225,000 名患者被處方了 Aimovig，並已開具了 100 萬張處方。此外，開立 Aimovig 處方的醫生數量也持續增加，自上市以來已有 27,000 名醫生開立了 Aimovig 處方，其中近 10,000 名是初級保健醫生。我們預計淨價在未來將保持相對穩定，因為大多數患者已從免費轉為付費，而且越來越多的患者享受折扣合約而非支付全額標價。

We launched a single, convenient, monthly Aimovig, a 140-milligram autoinjector, replacing the 2 by 70-milligram presentation. Coupled with a further expansion into retail, we believe there's a small onetime increase in the amount of product in the channel in the quarter to prepare for this demand. We're confident that Aimovig will continue to grow and contribute to the strength of Amgen's innovative portfolio.

我們推出了一款方便的單支裝 Aimovig，即 140 毫克自動注射器，取代了先前的 2 支裝 70 毫克自動注射器。隨著零售通路的進一步擴張，我們認為本季該通路的產品數量將出現一次性小幅增長，以滿足這一需求。我們相信Aimovig將繼續發展壯大，並為安進的創新產品組合做出貢獻。

Moving to our hematology and oncology business, the portfolio of XGEVA, KYPROLIS, Nplate, Vectibix, BLINCYTO and IMLYGIC collectively totaled $1.3 billion in the quarter, growing 10% year-over-year. For more detail on the larger brands, let's start with XGEVA on Slide 17. In Q2, XGEVA grew 10% year-over-year primarily from volume. In the U.S., share is approximately 60%, and we're seeing rapid growth in multiple myeloma patients, while also growing the number of treated solid tumor patients. KYPROLIS grew 2% year-on-year driven primarily by 13% volume growth in the U.S. Recall that in the second quarter of last year, our international business recognized $27 million in clinical trial purchases. And when normalizing for clinical trial purchases across periods, the underlying worldwide business grew 8%.

再來看我們的血液腫瘤業務，XGEVA、KYPROLIS、Nplate、Vectibix、BLINCYTO 和 IMLYGIC 的產品組合在本季總計達到 13 億美元，較去年同期成長 10%。有關大品牌的更多詳細信息，讓我們從第 17 張幻燈片中的 XGEVA 開始。第二季度，XGEVA年增10%，主要得益於銷售成長。在美國，這一比例約為 60%，我們看到多發性骨髓瘤患者數量迅速增長，同時接受治療的實體腫瘤患者數量也在增加。KYPROLIS 年成長 2%，主要得益於美國市場 13% 的銷售成長。回顧去年第二季度，我們的國際業務確認了 2,700 萬美元的臨床試驗採購收入。如果將臨床試驗採購按期間進行標準化，則全球基礎業務成長了 8%。

Moving to Enbrel, sales increased 5% year-over-year driven primarily by net selling price benefits. Overall, we expect volume trends to continue and anticipate a slight benefit from net selling price on a full year basis.

轉向恩利（Enbrel）後，銷售額年增 5%，主要得益於淨售價優勢。總體而言，我們預計銷售趨勢將持續，並預計全年淨售價將略有上漲。

Next, to Neulasta on Slide 20. Overall, the competitive dynamic is playing out as we expected on a global basis. In Q2, Neulasta sales declined 25% year-over-year, with a 24% decline in the U.S. Exit share of Neulasta in the U.S. was just under 80% in the long-acting segment, with absolute units of Onpro stable on a quarter-over-quarter basis as many providers and their patients continued to appreciate the benefits of Onpro. This performance reflects the confidence that our customers have in the reliability and quality of our supply. The decline in U.S. Neulasta units continues to come primarily from our prefilled syringe, reflecting a competitive biosimilar market. Regarding our international business, Neulasta declined 31% due to increasing competition.

接下來，請看第 20 張投影片上的 Neulasta。總體而言，全球範圍內的競爭格局正如我們預期的那樣發展。第二季度，Neulasta 的銷售額年減 25%，其中美國市場下降 24%。 Neulasta 在美國長效製劑市場的份額略低於 80%，而 Onpro 的絕對銷售量則是環比保持​​穩定，因為許多醫療服務提供者及其患者繼續認可 Onpro 的益處。這項業績反映了客戶對我們供貨可靠性和品質的信心。美國 Neulasta 銷售量的下降主要來自我們的預充式註射器，這反映出生物相似藥市場的競爭激烈。由於競爭加劇，Neulasta 的國際業務下滑了 31%。

Switching to nephrology starting on Slide 21. Q2 EPOGEN sales declined 11% due to lower net selling price. This quarter also benefited from approximately $15 million of large onetime end-customer purchases and $13 million in favorable changes to accounting estimates. Given our contractual pricing commitments with DaVita, net price will continue to decline for EPOGEN in 2019.

從第 21 張幻燈片開始，轉入腎臟病學部分。由於淨售價下降，EPOGEN 第二季銷售額下降了 11%。本季度還受益於約 1500 萬美元的大額一次性終端客戶採購和 1300 萬美元的會計估計有利變化。鑑於我們與 DaVita 簽訂的合約定價承諾，EPOGEN 的淨價將在 2019 年繼續下降。

Aranesp declined 8% year-over-year in Q2 driven by lower volume due to increased competition. We expect Aranesp sales to continue to decline at a faster rate in 2019 versus 2018, with both long-acting and short-acting competition in the U.S.

由於競爭加劇導致銷售下降，Aranesp 在第二季年減 8%。我們預計，由於美國市場存在長效和短效藥物的競爭，Aranesp 的銷售額在 2019 年將繼續以比 2018 年更快的速度下降。

Parsabiv continues to experience solid growth, more than doubling sales on a year-over-year basis. Independent and midsize dialysis providers utilize Parsabiv for a majority of their calcimimetic patients, while FMC and DaVita are increasing their adoption.

Parsabiv 持續保持穩健成長，銷售額年增超過一倍。獨立和中型透析服務提供者大多使用 Parsabiv 治療其鈣敏感受體激動劑患者，而 FMC 和 DaVita 正在增加其採用率。

Turning to Sensipar. As a result of some at-risk, small-molecule generic launches, you can see on Slide 24 that Q2 sales declined by approximately $300 million year-over-year. We believe that inventory of generic Sensipar remains in the market. Given ongoing legal proceedings, there remains uncertainty about the magnitude of future U.S. Sensipar sales.

改用Sensipar。由於一些風險較高的小分子仿製藥上市，您可以在第 24 張幻燈片中看到，第二季銷售額比去年同期下降了約 3 億美元。我們認為市面上仍有仿製藥Sensipar的庫存。鑑於目前的法律訴訟仍在進行中，Sensipar 在美國的未來銷售規模仍有不確定性。

I'd like to highlight the strong performance of our biosimilar products. Our launches of KANJINTI, our biosimilar to Herceptin, and AMGEVITA, our biosimilar to Humira, outside the U.S. are progressing in line with our expectations, annualizing at greater than $300 million. We also recently launched our first-ever biosimilars in the U.S., with KANJINTI and MVASI, our biosimilar to Avastin.

我想重點介紹一下我們生物相似藥產品的出色表現。我們在美國以外地區推出的 KANJINTI（赫賽汀的生物相似藥）和 AMGEVITA（阿達木單抗的生物相似藥）的上市進展順利，符合我們的預期，年銷售額超過 3 億美元。我們最近也在美國推出了首批生物相似藥，分別是 KANJINTI 和 MVASI，它們是 Avastin 的生物相似藥。

We are encouraged that our experience in the dynamics of both innovator and biosimilar molecules and our expertise in world-class biologic manufacturing will benefit us greatly in shaping and advancing this important market for patients and payers. In summary, I'm pleased to see that our careful planning for the evolution of our product portfolio is progressing nicely. I continue to believe we are well positioned to deliver volume growth in the future as we launch and grow new products, deliver value with biosimilar products and defend our mature brands. We're prepared for the challenges that face us and continue to drive toward providing patients with high-quality, innovative and biosimilar products in markets across the globe.

我們感到鼓舞的是，我們在創新藥和生物相似藥的動態發展方面的經驗，以及我們在世界一流生物製品製造方面的專業知識，將極大地幫助我們塑造和推進這個對患者和支付方都至關重要的市場。總而言之，我很高興地看到，我們為產品組合發展所做的精心規劃進展順利。我仍然相信，隨著我們推出和發展新產品、透過生物相似藥創造價值以及捍衛我們成熟的品牌，我們有能力在未來實現銷售成長。我們已準備好迎接挑戰，並將繼續努力為全球市場的患者提供高品質、創新和生物相似藥產品。

Now let me turn it over to Dave Reese.

現在讓我把麥克風交給戴夫·里斯。

Thanks, Murdo, and good afternoon, everyone. It's been a year since I assumed leadership of the R&D organization, and I wanted to take a moment to reflect on our progress. 2 of the core challenges facing any R&D group are improving success rates and decreasing the drug development cycle time. To address these challenges, we've created a research organization that has tightly integrated triple-threat capabilities, namely: 1, human genetics as a foundation; 2, core strength in biology; and 3, world-class molecular engineering. We have made tangible progress on all fronts, and I would like to highlight some recent announcements that build on this.

謝謝你，默多，大家下午好。我擔任研發部門領導已經一年了，我想藉此機會回顧我們所取得的進展。任何研發團隊面臨的兩大核心挑戰是提高成功率和縮短藥物研發週期。為了應對這些挑戰，我們創建了一個研究機構，該機構緊密整合了三項核心能力，即：1. 以人類遺傳學為基礎；2. 生物學方面的核心實力；以及 3. 世界一流的分子工程。我們在各方面都取得了實際進展，我想重點介紹一些建立在這些進展基礎上的最新公告。

The acquisition of deCODE Genetics gave us the industry-leading human genetics platform and we have expanded that capability. Today, there are about 1.6 million participants in the deCODE database. Last month, we announced the collaboration with Intermountain Health, a leading integrated delivery network here in the U.S. which will increase our sample size by up to 0.5 million over the next 5 years. This unique collaboration will give participants access to important genetic information as appropriate, allow the leaders of Intermountain to use genetics to improve population health and enhance our target discovery and development efforts. The platform we have put in place will solidify our lead in the use of human genetics for years to come.

收購 deCODE Genetics 讓我們獲得了業界領先的人類遺傳學平台，並且我們擴展了這項能力。目前，deCODE 資料庫中約有 160 萬名參與者。上個月，我們宣布與美國領先的綜合醫療服務網絡 Intermountain Health 展開合作，這將使我們的樣本量在未來 5 年內增加多達 50 萬人。這項獨特的合作將使參與者能夠酌情獲取重要的遺傳訊息，使 Intermountain 的領導者能夠利用遺傳學來改善人群健康，並加強我們的標靶發現和開發工作。我們所建立的平台將鞏固我們在未來幾年運用人類遺傳學領域的領先地位。

Another investment in our innovation engine was the acquisition of Nuevolution, now completed. We'd like to welcome our new colleagues in Copenhagen and look forward to integrating their world-class expertise in DNA-encoded library and other technologies into our research platform. These technologies enhance our small-molecule capabilities and our ability to engineer molecules that induce targeted protein degradation, on which we will place a major emphasis going forward.

我們為創新引擎所做的另一項投資是收購 Nuevolution，目前已完成。我們熱烈歡迎哥本哈根的新同事，並期待將他們在 DNA 編碼文庫和其他技術方面的世界級專業知識整合到我們的研究平台中。這些技術增強了我們的小分子能力和設計誘導靶向蛋白質降解的分子的能力，我們將在未來專注於發展這一領域。

Turning to our therapeutic areas. In cardiovascular disease, we have completed enrollment in our omecamtiv mecarbil Phase III outcome study. At over 8,000 patients, GALACTIC-HF is one of the largest heart failure clinical studies ever conducted and speaks to the emphasis we have placed on building a clinical trials platform that can deliver rapid and efficient study execution. This is an event-driven study, and we will provide updates on expected timing as events accumulate.

接下來談談我們的治療領域。在心血管疾病領域，我們已經完成了 omecamtiv mecarbil III 期療效研究的入組工作。GALACTIC-HF 研究納入了 8000 多名患者，是迄今為止規模最大的心臟衰竭臨床研究之一，這反映了我們對建立能夠快速且有效率地執行研究的臨床試驗平台的重視。這是一項事件驅動型研究，我們將隨著事件的累積提供預期時間的更新資訊。

With AMG 890, our LP(a) small interfering RNA program, we are now enrolling patients with known elevated LP(a) based on the data on the healthy human volunteers and anticipate launching the next phase of development in the first half of next year.

憑藉我們的 LP(a) 小幹擾 RNA 計畫 AMG 890，我們現在正在根據健康人類志願者的數據招募已知 LP(a) 水平升高的患者，並預計將於明年上半年啟動下一階段的開發。

In inflammation, enrollment in our tezepelumab Phase III asthma study continues on schedule, with data expected next year. We are also advancing AMG 570, a bispecific antibody peptide conjugate that targets ICOS ligand and BAFF into Phase II for the treatment of systematic lupus erythematosus. I will have more to say on AMG 570 as the program progresses.

在發炎方面，我們的 tezepelumab III 期氣喘研究的入組工作正在按計劃進行，預計明年將公佈數據。我們也正在推進 AMG 570 的研發，這是一種針對 ICOS 配體和 BAFF 的雙特異性抗體勝肽偶聯物，目前已進入 II 期臨床試驗，用於治療系統性紅斑狼瘡。隨著專案的推進，我將對AMG 570發表更多看法。

In our migraine portfolio, we recently presented additional long-term Aimovig data at the American Academy of Neurology and American Headache Society meetings that demonstrate sustained reductions in monthly migraine days. Aimovig is the only CGRP inhibitor with 4-year clinical data in migraine, with 77% of Aimovig patients achieving at least a 50% response, more than half achieving at least a 75% response and 1/3 achieving a 100% response in monthly migraine day reduction. No new safety signals were detected over the extended treatment period.

在我們的偏頭痛產品組合中，我們最近在美國神經病學學會和美國頭痛協會的會議上展示了更多 Aimovig 的長期數據，這些數據表明每月偏頭痛天數持續減少。Aimovig 是唯一擁有 4 年偏頭痛臨床數據的 CGRP 抑制劑，77% 的 Aimovig 患者每月偏頭痛天數減少 50% 以上，超過一半的患者每月偏頭痛天數減少 75% 以上，三分之一的患者每月偏頭痛天數減少 100%。在延長的治療期間，未檢測到新的安全訊號。

In bone health, EVENITY is now approved in Japan and the U.S., as Murdo discussed, and we also recently received approval in other countries, including Canada, Australia and South Korea. We were disappointed by the negative opinion for EVENITY in Europe by the CHMP. UCB has submitted a written notice to the European Medicines Agency requesting reexamination of the CHMP opinion, and we will support UCB in this endeavor. We strongly believe that EVENITY is an important treatment option in patients with postmenopausal osteoporosis, who are at high risk of fracture.

正如 Murdo 所討論的，在骨骼健康領域，EVENITY 目前已在日本和美國獲得批准，我們最近在其他國家也獲得了批准，包括加拿大、澳洲和韓國。我們對歐洲藥品管理局 (CHMP) 對 EVENITY 的負面評價感到失望。UCB已向歐洲藥品管理局提交書面通知，要求重新審查CHMP的意見，我們將支持UCB的這項努力。我們堅信，對於患有停經後骨質疏鬆症、骨折風險較高的患者而言，EVENITY 是重要的治療選擇。

Turning to oncology. I'll begin with AMG 510, our KRAS G12C inhibitor. After nearly 4 decades of research in the pursuit of a KRAS inhibitor, the response from the medical community to our first-in-human data at ASCO was simply overwhelming. We reported a 50% response rate in non-small cell lung cancer and very encouraging stable disease data in colorectal cancer, with a tolerable adverse event profile. Today, I am pleased to report that we now have formal tumor responses in colorectal and appendiceal cancer patients and the program is moving forward rapidly. We have completed enrollment in our monotherapy expansion cohort and are also now enrolling non-small cell lung cancer patients in the PD-1 combination arm. We will also begin enrollment of lung cancer patients in the coming days in the potential registration enabling Phase II monotherapy portion of the program, and we'll provide an update of our progress in lung cancer at the 2019 World Conference on Lung Cancer in early September. I would highlight that we are coming up on just 1 year since initially entering the clinic in August of 2018. We remain extraordinarily enthusiastic about the promise of AMG 510 and continue to aggressively prosecute the development program.

轉向腫瘤學。我先從AMG 510說起，它就是我們的KRAS G12C抑制劑。經過近 40 年對 KRAS 抑制劑的研究，我們在 ASCO 上發表的首個人體試驗數據受到了醫學界的熱烈反響。我們報告稱，非小細胞肺癌的緩解率為 50%，大腸直腸癌的病情穩定數據非常令人鼓舞，且不良事件發生率可耐受。今天，我很高興地報告，我們現在已經對結直腸癌和闌尾癌患者進行了正式的腫瘤反應研究，並且該計畫正在快速推進。我們已經完成了單藥治療擴展隊列的招募工作，現在也正在招募非小細胞肺癌患者加入 PD-1 合併治療組。我們將在未來幾天開始招募肺癌患者參與該計畫潛在的註冊性 II 期單藥治療部分，並將在 9 月初舉行的 2019 年世界肺癌大會上提供我們肺癌研究進展的最新資訊。我想強調的是，從 2018 年 8 月首次進入診所至今，我們即將迎來一年的紀念日。我們對 AMG 510 的前景依然充滿熱情，並將繼續積極推進研發計劃。

Turning to our BiTE platform. We presented the first solid tumor data from a BiTE molecule at ASCO with AMG 212, our prostate-specific membrane antigen BiTE molecule for castrate-resistant prostate cancer. The initial data were very encouraging, and we are currently in dose escalation with an extended half-life BiTE molecule, AMG 160. At ASCO, we also provided an update on our BCMA program with our canonical BiTE molecule, AMG 420, showing durability out beyond a year in some multiple myeloma patients.

切換到我們的 BiTE 平台。我們在 ASCO 上展示了 BiTE 分子 AMG 212 的首個實體瘤數據，AMG 212 是我們針對去勢抵抗性前列腺癌的前列腺特異性膜抗原 BiTE 分子。初步數據非常令人鼓舞，我們目前正在使用半衰期延長的 BiTE 分子 AMG 160 進行劑量遞增試驗。在 ASCO 會議上，我們也介紹了我們的 BCMA 計畫的最新進展，該計畫採用了我們經典的 BiTE 分子 AMG 420，在一些多發性骨髓瘤患者中顯示出超過一年的持久療效。

AMG 701, our half-life extended BCMA BiTE molecule, continues to advance nicely through dose escalation, and we expect to present the initial first-in-human data at a medical meeting next spring depending on data availability.

我們的半衰期延長型 BCMA BiTE 分子 AMG 701 在劑量遞增方面繼續取得良好進展，我們預計將於明年春季的醫學會議上公佈首次人體試驗的初步數據，具體取決於數據的可用性。

Before I leave oncology, I would note that we have paused our DLL3 and FLT3 CAR T programs in the Kite collaboration. We continue to have a keen interest in cellular therapies. However, in light of our growing confidence in the BiTE platform, we will maintain our immediate strategic focus on the BiTE molecules and direct our efforts and cellular therapy towards developing new-generation technologies likely through collaborations.

在我離開腫瘤科之前，我想指出，我們已經暫停了與 Kite 合作的 DLL3 和 FLT3 CAR T 計畫。我們對細胞療法一直抱有濃厚的興趣。然而，鑑於我們對 BiTE 平台的信心日益增強，我們將繼續把當前的策略重點放在 BiTE 分子上，並將我們的努力和細胞療法轉向開發新一代技術，這很可能是透過合作實現的。

Briefly, in biosimilars. We received FDA approval for KANJINTI for all approved indications of Herceptin. The non-Hodgkin's lymphoma study of ABP 798, our biosimilar Rituxan, has completed dosing, and we expect to have the data in-house by the end of Q3. And finally, the FDA review of ABP 710, our biosimilar REMICADE, continues to progress toward the BsUFA target action date in December. Bob?

簡而言之，在生物相似藥中。KANJINTI 已獲得 FDA 批准，可用於赫賽汀的所有已批准適應症。我們的生物相似藥利妥昔單抗（Rituxan）ABP 798 的非何杰金氏淋巴瘤研究已完成給藥，我們預計將在第三季末獲得內部數據。最後，FDA 對我們的生物相似藥 REMICADE（ABP 710）的審查繼續推進，目標是在 12 月獲得 BsUFA 目標批准。鮑伯？

Okay. Thanks, David. Ian, now let's turn to questions. And out of respect for the fact that we started an hour later than usual, we'll try to move briskly through this, so if you could please remind our callers of the procedure for questions, we can get started.

好的。謝謝你，大衛。伊恩，現在我們來問問題。考慮到我們比平常晚了一個小時開始，我們會盡量加快速度，所以如果您能提醒一下來電者提問的流程，我們就可以開始了。

(Operator Instructions) Our first question is from the line of Ronny Gal from Bernstein.

（操作說明）我們的第一個問題來自伯恩斯坦的 Ronny Gal 的線路。

Congratulations on a nice quarter. Biosimilars, I'd like to ask one on attacking and defending side. First, congratulations on the launch of the 2 biosimilars in the United States. For KANJINTI, you have only the 420 mg and not the 150 mg yet. Can you give us a time line for when do you think you're going to get the lower dose then, and do you think it will have an impact on the initial uptake? And on the defending side, looking at Neulasta. Would you be able to share with us kind of like the trends in the clinic, non-340B hospitals and 340B hospitals? Where is the adoption of biosimilars right now?

恭喜你本季業績出色。關於生物相似藥，我想請教一下進攻方和防守方的問題。首先，恭喜這兩款生物相似藥在美國上市。對於 KANJINTI，目前只有 420 毫克規格，還沒有 150 毫克規格。您能否告知我們您預計何時能獲得較低劑量，以及您認為這會對初始吸收產生影響嗎？防守方面，我們來看看紐拉斯塔。您能否和我們分享診所、非 340B 醫院和 340B 醫院的發展趨勢？目前生物相似藥的應用情況如何？

Okay. Ronny. Thanks for the question. We'll take it in 2 parts. Murdo, do you have the answer to the first question on the 150?

好的。羅尼。謝謝你的提問。我們將分兩部分進行。Murdo，你知道150題第一個問題的答案嗎？

Yes. So I don't have the exact timing for you, Ronny, but we're not seeing a whole lot of resistance in the market initially to the conversations we're having with payers, hospitals and providers. We're seeing good response to KANJINTI and MVASI, and we feel good about our ability to compete with the presentations we have in the market right now.

是的。羅尼，我無法告訴你確切的時間，但我們目前與支付方、醫院和醫療服務提供者進行的對話，在市場上並沒有遇到太大的阻力。我們看到KANJINTI和MVASI的市場反應良好，我們對目前市場上的同類產品充滿信心，相信我們有能力與之競爭。

And then on Neulasta, we continue to see the effects of biosimilar competition as we had anticipated. We are seeing an uptick of biosimilars in the 340B channel. We're also seeing a stronger performance of biosimilars in business that we have not contracted. So again, that is as we would have expected. But we're also seeing strong performance of Onpro on a unit basis quarter-over-quarter holding in a majority of accounts. And that's something that we had hoped to see by now, and we're feeling good that, that continues to happen. And overall, I think it's recognized in the market that the ability for Amgen to supply high-quality reliability on our overall long-acting filgrastim business is being appreciated and continuing to support that franchise.

至於 Neulasta，我們繼續看到生物相似藥競爭的影響，正如我們預期的那樣。我們看到 340B 渠道的生物相似藥數量增加。我們也看到，在尚未簽訂合約的業務中，生物相似藥的表現也更加強勁。所以，這和我們預想的一樣。但我們也看到，Onpro 在大多數帳戶中，按季度環比持倉量計算，表現強勁。而這正是我們一直希望看到的，我們很高興看到這種情況繼續發生。總的來說，我認為市場已經認識到安進公司能夠為其長效非格司亭業務提供高品質、高可靠性的產品，這一點得到了認可，並將繼續支持該業務。

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

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

Just on AMG 510. So kind of keen on your commentary on the tumor responses in CRC. So I wonder if you could maybe give some clarity here. Are these new patients that were enrolled and got maybe the 960-milligram dose? Or were these -- I know you have had an option for patients to have intrapatient up-dosing. So any color there in terms of who responded would be great. And then maybe a second part of that question, also on the registration trial starting this year. I know you said it's in lung, but just kind of wondering if you could give some color on the design in the setting and what constitutes maybe a control in third-line lung would be great.

僅限AMG 510。我對您對CRC腫瘤反應的評論很感興趣。所以我想請您幫忙解釋一下。這些是新入組的患者，他們可能接受了 960 毫克的劑量嗎？或者這些是——我知道你們有為病人提供在住院期間增加劑量的選擇。所以，如果能提供回覆者的任何資訊就太好了。然後，或許可以問這個問題的第二部分，也是關於今年開始的註冊試驗。我知道你說過是在肺部，但我只是想知道，如果你能就此設計在背景中的情況以及構成三線肺部控制的因素做一些描述，那就太好了。

Yes. Sure. With regard to colorectal, the majority of patients that we're reporting going forward will have been treated at 960 milligrams. As you may recall, at ASCO, we only had, I think, one patient at that point who was on that dose level. And so we'll provide updates in that particular indication as we accumulate data towards the end of the year and the first part of next year when we have enough patients at the target dose to get a real sense of the clinical activity.

是的。當然。就大腸癌而言，我們今後報告的大多數患者都將接受 960 毫克的治療。您可能還記得，在 ASCO 會議上，當時我們只有一位患者接受了該劑量等級的治療。因此，隨著我們在今年年底和明年年初累積數據，當達到目標劑量的患者數量足夠多，能夠真正了解臨床療效時，我們將提供該特定適應症的最新資訊。

In terms of potential registration plans, we would assume that lung cancer will be the lead indication going forward. As I mentioned, in the coming days, we will be enrolling in the Phase II portion of that program. We're moving very, very rapidly, and we'll provide updates on that particular pathway as we go forward. But I would say we've had productive discussions with regulatory authorities and have a good sense of the pathways moving forward.

就潛在的註冊計劃而言，我們認為肺癌將是未來的主要適應症。正如我之前提到的，在接下來的幾天裡，我們將參加這個計畫的第二階段。我們正在以非常非常快的速度推進，我們將隨著工作的進展及時提供相關資訊。但我認為，我們與監管機構進行了富有成效的討論，並且對未來的發展方向有了清晰的認識。

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 guess another pipeline question for me. Can you just clarify on the half-life extended BiTEs what your view on the data that we may see in the fall and what that data needs to look like versus the canonical BiTEs that you've reported so far in terms of efficacy and safety to move those programs ahead?

看來我又得問一個關於管道的問題了。您能否澄清一下關於半衰期延長的BiTEs，您對我們可能在秋季看到的數據有何看法？與您迄今為止報告的經典BiTEs相比，這些數據在療效和安全性方面需要達到什麼水平才能推進這些項目？

Yes. I think, Matt, as we've said in the past, in general, we will prefer the half-life extended program, all things being equal, meaning seeing efficacy and safety profiles that are comparable to what one would expect with a short half-life or a first-generation BiTE. Based on emerging data, I think we're getting increasing confidence in the half-life extended program, and we'll look forward to sharing those data across both hematologic malignancies and solid tumors as we go forward.

是的。我認為，馬特，正如我們過去所說，總的來說，在其他條件相同的情況下，我們會更傾向於半衰期延長的方案，這意味著療效和安全性與短半衰期或第一代 BiTE 的預期效果相當。根據新出現的數據，我認為我們對延長半衰期計畫的信心越來越強，我們期待在未來將這些數據分享給血液惡性腫瘤和實體腫瘤患者。

And our next question is from the line of Evan Seigerman from Crédit Suisse.

我們的下一個問題來自瑞士信貸的 Evan Seigerman。

So on your recent biosimilar launches in the United States, how do you really compete with the innovator of molecules? And I guess what structural changes do you need to see in the U.S. health care system to encourage more use of biosimilars? And what's your view on the broad use of rebates to protect branded biologics in light of biosimilar competition? So there's a few in there.

那麼，在您最近於美國推出的生物相似藥中，您究竟該如何與分子創新者競爭呢？那麼，您認為美國醫療保健系統需要哪些結構性變革才能鼓勵更多使用生物相似藥？鑑於生物相似藥的競爭，您如何看待廣泛使用回扣來保護品牌生物製劑的做法？裡面有一些。

Yes. There's a few questions in there. I'll take these in parts. Go ahead, Evan -- or sorry, go ahead. Go ahead, Murdo.

是的。裡面有幾個問題。我會分部分進行。請繼續，埃文——或者，抱歉，請繼續。來吧，默多。

Yes. Evan, thank you. I mean the gist of your question seemed to surround the viability of the biosimilar market in the U.S., and I think, in 2 parts, we are seeing a very healthy competitive biosimilar market evolve. We're experiencing competition on Neulasta, and we anticipate being able to compete effectively with our new biosimilar launches with both MVASI and KANJINTI.

是的。埃文，謝謝你。我的意思是，你的問題似乎主要圍繞著美國生物相似藥市場的可行性，我認為，從兩個方面來看，我們正在看到一個非常健康且具有競爭力的生物相似藥市場正在發展。我們在 Neulasta 方面面臨競爭，我們預計憑藉我們新推出的生物相似藥 MVASI 和 KANJINTI，能夠有效地與之競爭。

I think, competitively, where Amgen differentiates is in the fact that we have 4 decades of high-quality reliable supply in the market. We are able to offer physician and patient educational services and reimbursement support. And we're also able to cover many of these customers who will be making treatment decisions using our biosimilars given our strong history and experience in the oncology sector. I also think that the dynamics on pricing and competition, while fluid, are less of a barrier than they once were. And I think that we'll continue to see deeper and deeper penetration of biosimilars against originator products in the U.S. in the future. And I will just remind you that we have many years of experience now outside of the U.S. in Europe in biosimilars, and I think the market in Europe started slow and has since become a very mature, very attractive market for biosimilars manufacturers.

我認為，從競爭角度來看，安進的優勢在於我們在市場上擁有 40 年的高品質可靠供應。我們能夠為醫生和患者提供教育服務和報銷支援。鑑於我們在腫瘤領域的悠久歷史和豐富經驗，我們也能為許多將使用我們的生物相似藥做出治療決策的客戶提供服務。我也認為，儘管價格和競爭的動態變化不斷，但其帶來的障礙已經不如以往那麼大了。我認為，未來生物相似藥在美國市場對原廠藥的滲透率將會越來越高。我還要提醒各位，我們在美國以外的歐洲生物相似藥領域已經積累了多年的經驗，我認為歐洲市場起步緩慢，但現在已經發展成為一個非常成熟、對生物類似藥生產商極具吸引力的市場。

I think I'll just add there, Evan, from a policy perspective there. Some in the industry who are advocating for changes that would favor biosimilars over the innovator molecules, we are not among them. We think that what the country needs is a long-term, vibrant competitive marketplace for biosimilars, and our fear would be anything that tilts the playing field to biosimilars might perversely have the long-term effect of diminishing the competitive opportunity in the U.S. And we want to avoid what has happened, for example, in the small-molecule generic industry in the U.S., where there are unfortunate market abuses relating to the fact that there are single companies left with the license to manufacture individual generic products. So we think that for the long run, what the country needs is a vibrant competitive market for biosimilars, produced safely and reliably by competitors that can run a fair return for their effort. And we think we'll be able to do that without having to have policies that tilt the playing field in favor of those biosimilar molecules.

我想從政策角度補充一點，艾文。業界有些人鼓吹變革，使生物相似藥優於創新藥，但我們並不屬於這一陣營。我們認為，美國需要的是一個長期、充滿活力的生物相似藥競爭市場，我們擔心任何使競爭環境向生物相似藥傾斜的因素，都可能產生適得其反的長期影響，削弱美國的競爭機會。我們希望避免重蹈覆轍，例如美國小分子仿製藥行業的情況，那裡存在一些不幸的市場濫用現象，因為只有少數幾家公司擁有生產特定仿製藥產品的許可證。因此我們認為，從長遠來看，國家需要的是一個充滿活力的生物相似藥競爭市場，由競爭對手安全可靠地生產，並能從中獲得公平的回報。我們認為，即使不制定有利於生物相似藥分子的政策，我們也能做到這一點。

And if I can just jump in to close Ronny Gal's earlier question. The FDA action date on KANJINTI, 150 milligrams SKU, is October 28, 2019.

我可以插一句，回答一下 Ronny Gal 之前提出的問題嗎？FDA 對 KANJINTI（150 毫克 SKU）的核准日期為 2019 年 10 月 28 日。

And our next question is from the line of Yaron Werber from Cowen.

我們的下一個問題來自 Cowen 公司的 Yaron Werber。

And David, I have a follow-up there also on 510 a little bit in 2 parts. Maybe the first one, the -- what can you share with us on solubility or formulation of the compound? We understand that solubility is better and the gastric acidity a little bit lower than the intestinal. So what you see there, is there anything special on the formulation? And then on the CRC side, as you contemplate combo as the next stage, now that you're seeing single-agent activity, are you thinking a PD-1 combo or is that going to be a TKI combo next?

大衛，關於 510，我還有後續報道，分成兩部分。或許第一個問題是──您能和我們分享一下該化合物的溶解度或配方方面的資訊嗎？我們知道，胃的溶解度比腸道好，胃酸度也比腸道略低。那你看到的配方有什麼特別之處嗎？那麼在 CRC 方面，既然您已經看到了單藥活性，並且正在考慮下一步的聯合治療，那麼您是在考慮 PD-1 聯合治療，還是下一步會考慮 TKI 聯合治療呢？

Sure. So let me take both of those questions in turn, Yaron. In terms of solubility, I would say, broadly, we've been very happy with the pharmacokinetic and pharmacodynamic profile of the drug. And again, to remind everyone, with a covalent inhibitor, the key is really to maintain exposures above a target level for a period of time that is adequate to poison the target through a dosing interval. And based on what we've seen in the clinic to date now across several dozen patients gives us the confidence that we've got a very attractive pharmacokinetic profile.

當然。那麼，亞倫，讓我依序回答這兩個問題。就溶解度而言，總的來說，我們對藥物的藥物動力學和藥效學特徵非常滿意。再次提醒大家，對於共價抑制劑而言，關鍵在於透過給藥間隔，將暴露量維持在目標水準以上一段時間，以足以毒害目標。根據我們目前在臨床上對數十名患者的觀察，我們有信心認為我們獲得了非常有吸引力的藥物動力學特徵。

In terms of colorectal cancer, obviously, combinations will be of great interest going forward, I would say, potentially, both with immunotherapeutic agents and additional targeted therapies. And as that program moves forward, we'll provide additional guidance a little later in the year and early into next year.

就大腸癌而言，顯然，聯合療法在未來將備受關注，我認為，無論是免疫療法或其他標靶療法，都可能成為聯合療法。隨著該計劃的推進，我們將在今年稍後和明年年初提供更多指導。

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。

And I'll try and confine myself to 3 subparts. I guess the main question that we are still being asked is about the Sandoz litigation. And I think we all expected that we would get a result from the district court by now. And I'm sure you can't really comment, but could you talk hypothetically perhaps about what your fallbacks might be if, unexpectedly, your issued patent was overturned? Should we be anticipating that there is a risk of rapid erosion of Enbrel sort of along in your last trajectory? Or could you kind of give us some thoughts, Bob, on how the outlook is for that?

我會盡量將內容限制在 3 個小部分。我想我們仍然被問到的主要問題是關於山德士訴訟案的。我想我們都預料到現在應該已經從地方法院得到判決結果了。我知道您不方便對此發表評論，但您能否假設性地談談，如果您的已頒發專利意外被推翻，您的備選方案是什麼？我們是否應該預料到，恩利（Enbrel）可能會像您上次預測的那樣迅速衰落？鮑勃，您能否就這方面的前景談談您的看法？

Sure. Geoff, I understand that you're anxious for an answer from the courts, and of course, so are we. We are, as you know, confident in the intellectual property surrounding Enbrel. So we don't know any more than you do about when we will expect that, when we should expect that decision. But if for whatever reason, that decision were to surprise us and go against us, as you can imagine, we would appeal that because, again, we feel that we have robust intellectual property for the molecule and we intend for that intellectual property be respected. So I think as to the hypothetical question about competition for Enbrel, we'll defer discussing that, Geoff, at this time. Thanks.

當然。傑夫，我知道你很想知道法院的答复，當然，我們也是。如您所知，我們對恩利（Enbrel）相關的智慧財產權充滿信心。所以，我們和你們一樣，對何時才能做出決定，何時該做出決定，也一無所知。但如果出於某種原因，該決定出乎我們的意料，對我們不利，正如您所能想像的，我們將提出上訴，因為我們再次認為我們擁有該分子的強大知識產權，我們希望該知識產權得到尊重。所以，關於恩利（Enbrel）的競爭問題，我認為我們暫時還是不要討論這個問題了，傑夫。謝謝。

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。

I had one question with 3 parts. It's all just a clarification. So thank you for that update on KRAS, and you've mentioned formal tumor responses. I wanted to ask, just to clarify, a) are these RECIST responses? Number one. Number two, can you confirm if it's more than one response in colorectal, or you can only have one colorectal and one appendiceal? And finally, also, at what dose level?

我有一個問題，包含三個部分。這只是澄清而已。非常感謝您提供的關於 KRAS 的最新信息，您也提到了正式的腫瘤反應。我想問一下，澄清一下，a) 這些是 RECIST 回應嗎？第一。第二，你能確認一下，大腸直腸癌是不只一種反應，還是只能有一種大腸直腸癌和一種闌尾癌嗎？最後，劑量水平是多少？

Yes. So taking those 3 parts in turn. Yes, these are RECIST responses, which is what I alluded to by saying formal tumor responses. It is a patient each in colorectal cancer and appendiceal cancer. These -- many of the patients dosed have yet to have repeat scans done, so we expect in the coming few months to have a large amount of additional data at the target dose. Recall that we just opened the expansion cohort not long ago and have had a flood of patients enrolling on that. We are continuing to see very good tolerability. I've been involved in Phase I drug development for a long time now, and I can say I'm only very impressed with the emerging safety profile that we are seeing with AMG 510.

是的。所以，我們依序來看這三個部分。是的，這些是RECIST反應，這就是我所說的正式腫瘤反應。這是一名患有大腸直腸癌和一名患有闌尾癌的患者。這些——許多接受治療的患者還沒有進行複查掃描，因此我們預計在接下來的幾個月裡，我們將獲得大量目標劑量下的額外數據。請記住，我們不久前才啟動了擴展隊列研究，並且已經有大量患者報名參加。我們持續觀察到良好的耐受性。我參與 I 期藥物開發已經很長一段時間了，我可以說，AMG 510 目前展現出的安全性給我留下了非常深刻的印象。

Dose levels?

劑量水平？

Dose levels. Going forward, it's all at the 960 milligrams.

劑量水平。今後，劑量都將定在 960 毫克。

And our next question is from the line of Mohit Bansal from Citigroup.

下一個問題來自花旗集團的莫希特·班薩爾。

And thanks, Arvind, for the shout out. A quick one on your Lp(a) candidate. Could you please compare and contrast your siRNA approach versus the oligonucleotide approach mechanistically? And should we expect some favorable results when you see the data later this year or early next year?

感謝 Arvind 的推薦。關於您的LP(A)候選人，我有一個簡短的問題。請您從機制上比較和對比一下您的siRNA方法和寡核苷酸方法？那麼，當您在今年稍後或明年年初看到數據時，我們是否可以期待一些有利的結果？

Yes. I'll be happy to address that question. So the question is around Lp(a). We've seen, I would say, very encouraging data in the healthy volunteer portion of the first-in-human study. We are now dosing patients with elevated Lp(a) levels and expect to move into the next phase of that development program based on the promising clinical data that we've seen to date in the early part of next year. We -- like the siRNA approach. I can't comment specifically on other's molecules and antisense oligonucleotides. In the long term, safety will be a critical component of any of these development programs. In addition, I would point out that something like siRNA will probably be required to tackle Lp(a) because of the nature of the molecule and the types of modalities that will be necessary to actually lower levels.

是的。我很樂意回答這個問題。所以問題圍繞著 Lp(a) 展開。我認為，在首次人體試驗的健康志願者部分，我們已經看到了非常令人鼓舞的數據。我們現在正在給 Lp(a) 水平升高的患者用藥，並希望根據我們迄今為止看到的有希望的臨床數據，在明年年初進入該開發計劃的下一階段。我們－喜歡siRNA方法。我無法對其他人的分子和反義寡核苷酸做出具體評論。從長遠來看，安全將是所有這些發展計畫的關鍵組成部分。此外，我想指出，由於 Lp(a) 分子的性質以及降低其水平所需的治療方式類型，可能需要像 siRNA 這樣的技術來應對 Lp(a)。

And our next question is from the line of Terence Flynn from Goldman Sachs.

下一個問題來自高盛的 Terence Flynn。

Maybe, Bob, a big picture one. We've obviously seen a lot of M&A in the space recently. Just as you think about your capital allocation strategy, how does the Enbrel litigation, I guess, fit into that? And again, as you think big picture at what's going on in the industry, how are you thinking about where Amgen can maybe play a role or a part?

或許，鮑勃，應該從大局來看。顯然，我們最近在這個領域看到了很多併購活動。正如您在考慮資本配置策略時，我想，Enbrel訴訟案會如何影響您的策略？再說一遍，從產業大局來看，您認為安進可以在哪些方面發揮作用？

I think, Terence, as I said in my remarks, we have a strong cash flow, a strong balance sheet. We think the company is performing well. And we think we can grow the business organically, and we're also looking at ways to grow through business development. So we're -- I'd expect that we will continue to be disciplined looking at opportunities and our stated areas of therapeutic interest in the geographic regions where we have stated our desire to expand. But again, we have a world-class business development effort, and we continue to look at opportunities, large and small.

特倫斯，我認為，正如我剛才所說，我們擁有強勁的現金流和穩健的資產負債表。我們認為該公司業績良好。我們認為我們可以透過自身發展實現業務成長，同時也在尋求透過業務拓展實現成長的方法。因此，我預計我們將繼續保持嚴謹的態度，專注於機會以及我們在已表明希望擴張的地理區域中感興趣的治療領域。但是，我們擁有世界一流的業務拓展能力，我們將繼續尋找各種規模的機會。

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 one for Murdo on Neulasta. I guess I was just thinking about your guidance on the majority of the erosion coming from the prefilled syringe. Should we think that this is basically gone now given that Onpro still commands sort of mid-60% of this market and sales are down sort of 30% since biosimilar competition? Or have we basically seen the impact of the biosimilars, or is there is still more erosion to come?

或許可以寫一篇給紐拉斯塔的默多。我當時正在思考您關於大部分侵蝕是由預填充注射器造成的指導意見。鑑於 Onpro 仍然佔據著約 60% 的市場份額，而自生物類似藥競爭以來銷售額下降了大約 30%，我們是否應該認為這種情況已經基本消失了？或者我們基本上已經看到了生物相似藥的影響，還是說未來還會有更大的侵蝕？

Yes. Thanks, Kennen. The trends that we're seeing are a function of obviously having now 2 competition -- 2 competitors in the market. And since the advent of the second competitor, we've seen -- clearly seen more volume erosion and more price erosion. We are assuming that we could still see an additional competitor this year. And I would say that the current trends on the prefilled syringe will continue, and we may see some price pressure on Onpro. What we are seeing with Onpro is stable unit evolution quarter-on-quarter, and that makes us feel good about the differentiation that Onpro provides both physicians and patients and the convenience and persistency that it offers. I think, looking forward, we continue to think that this is going to be a competitive biosimilar place -- space.

是的。謝謝你，肯南。我們看到的這些趨勢，顯然是由於現在市場上出現了兩家競爭對手——兩家競爭對手。自從第二個競爭對手出現以來，我們已經清楚地看到銷量和價格都出現了更大的下滑。我們預計今年可能還會出現另一家競爭對手。我認為預充式註射器的當前趨勢將會持續，我們可能會看到 Onpro 的價格面臨一些壓力。我們看到 Onpro 的銷售每季都在穩定成長，這讓我們對 Onpro 為醫生和患者帶來的差異化優勢、便利性和持久性感到滿意。展望未來，我認為我們仍然認為這將是一個競爭激烈的生物相似藥領域。

And our next question is from the line of Jay Olson from Oppenheimer.

我們的下一個問題來自奧本海默公司的傑伊·奧爾森。

Congrats on the quarter. There was a recent German court ruling in favor of Amgen confirming that Praluent infringes on your PCSK9 patents. And I was wondering if you could please share any thoughts you had on how market dynamics may evolve in Germany or other markets, if there are any, where Praluent may no longer be available.

恭喜你本季取得佳績。德國法院最近做出有利於安進公司的裁決，確認 Praluent 侵犯了您的 PCSK9 專利。我想請您分享您對德國或其他市場（如果有的話）的市場動態可能如何演變的看法，因為在這些市場中，Praluent 可能不再可用。

Yes, thanks for the question, Jay. First, the European Patent Office upheld our intellectual property for Repatha and upheld the innovative contribution that we've made to the field with that product. The German courts found that they infringed obviously that IP and instructed them to -- will be removed from the market. Sanofi filed an appeal and that matter is under review. Our focus, of course, will be on making sure that whichever patients need a therapy are able to receive it, and we think we're in position to be able to satisfy the needs of that market. But I think you're right that Germany is another market now where our IP has been upheld. As I said, the European Patent Office upheld our IP more broadly in that region. That follows Japan, which has also found in our favor. And of course, as you know, we've had 2 trials in court in the U.S. on the matter, both of which where jury trials had found in our favor. So the IP process continues to move forward in Europe, Asia and the United States.

是的，謝謝你的提問，傑伊。首先，歐洲專利局維護了我們對 Repatha 的智慧財產權，並維護了我們憑藉該產品對該領域做出的創新貢獻。德國法院認定他們明顯侵犯了智慧財產權，並命令他們將產品撤出市場。賽諾菲已提起上訴，目前該事項正在審查中。當然，我們的重點是確保所有需要治療的患者都能得到治療，我們認為我們有能力滿足該市場的需求。但我認為你說得對，德國現在是另一個我們的智慧財產權得到維護的市場。正如我所說，歐洲專利局在該地區更廣泛地維護了我們的智慧財產權。繼日本之後，日本也做出了對我們有利的決定。當然，正如您所知，我們在美國就此事進行了兩次法庭審判，兩次審判的陪審團都判我們勝訴。因此，智慧財產權進程在歐洲、亞洲和美國繼續向前推進。

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。

David Reese, on KRAS, you talked about responses in colorectal, et cetera. Maybe just going back to lung. Can you comment on confidence around longer-term durability in monotherapy? And then to the comments around enrollment with the combination PD-1, talk about what you would expect to see there and when we could get first data, as I -- obviously, I would assume that's an exciting opportunity.

David Reese，關於 KRAS，你談到了大腸直腸癌等疾病的反應。或許還是得回到肺部檢查。您能否談談人們對單藥治療長期療效的信心？然後，關於PD-1聯合療法的註冊情況，請談談您預期會看到什麼，以及我們何時可以獲得第一批數據，因為我——顯然，我認為這是一個令人興奮的機會。

Yes, thanks, Mike. Yes, in terms of durability, as I mentioned, we will be presenting a clinical update at the World Lung Conference in September. But I would say that, to date, we've been favorably impressed with potential durability. We have to all recall that it's early days and many of these patients have been recently enrolled on trials, so we'll gain further insight into durability as time goes on. But at least, to date, we are not seeing, for example, the rapid emergence of resistance.

好的，謝謝你，麥克。是的，就耐久性而言，正如我所提到的，我們將在 9 月的世界肺臟大會上發布臨床最新進展。但就目前而言，我們對它的潛在耐用性印象深刻。我們都必須記住，現在還處於早期階段，而且這些患者中有很多都是最近才加入試驗的，所以隨著時間的推移，我們會對療效的持久性有更深入的了解。但至少到目前為止，我們還沒有看到，例如，抵抗運動的迅速出現。

In the PD-1 combinations, we have what I think are very strong preclinical data suggesting potential synergistic interactions between KRAS inhibition and checkpoint inhibition probably due to enhanced immune infiltration and upregulation of Class I MHC on tumor cells. And our goal with that kind of combination would, of course, be very long-lasting durable remissions.

在 PD-1 聯合療法中，我們擁有非常強有力的臨床前數據，表明 KRAS 抑制和檢查點抑制之間可能存在協同作用，這可能是由於增強的免疫浸潤和腫瘤細胞上 I 類 MHC 的上調所致。當然，我們採用這種組合療法的目標就是要達到非常持久的緩解。

And our next question is from the line of Alethia Young from Cantor Fitzgerald.

我們的下一個問題來自坎托·菲茨杰拉德的阿萊西亞·楊的詩句。

One question and maybe one clarification. Just can you talk a little bit about in the Repatha situation with the co-pays, like kind of where are the moving pieces there to kind of get the ball rolling? Is it just mostly negotiations? And maybe why is it occurring? And then on KRAS, are you planning on dosing beyond 960 in colorectal?

一個問題，或許還需要一個澄清。您能否談談 Repatha 的共同支付情況，例如有哪些環節需要協調才能推動事情進展？主要就是談判嗎？那它發生的原因是什麼？那麼關於 KRAS，您是否計劃在結直腸癌中使用超過 960 的劑量？

Okay. So Alethia, maybe I can start with the Repatha question, and then I'll turn it over to Dave. As you know, the PCSK9 market is a competitive one. And given that competition, last year, there were payer negotiations and contracts that occurred, and since then, some commercial access improvements have been realized. I would say that our reduction of the -- our introduction of the low list price Repatha in October of last year was to try to improve the Medicare Part D reimbursement, and we recognized at the time that we were off-cycle or mid-cycle in the normal process by which PBMs and other payers produce their Part D benefit designs. And so while we had hoped that some payers and PBMs would move quickly to add low list price Repatha to Medicare Part D formularies at a fixed co-pay, that has not transpired. So we are optimistic that we will be able to make a significant improvement in Medicare Part D fixed co-pay listings for Repatha as we enter the 2020 Medicare Part D formulary benefit year, and we will know that in the fourth quarter.

好的。那麼，阿萊西亞，或許我可以先回答關於瑞帕莎的問題，然後再交給戴夫。如你所知，PCSK9市場競爭非常激烈。鑑於這種競爭，去年發生了支付方談判和合約簽訂的情況，從那以後，商業准入方面取得了一些進展。我認為，我們在去年 10 月推出低價 Repatha 的目的是為了改善 Medicare Part D 的報銷情況，當時我們意識到，我們正處於 PBM 和其他支付方制定 Part D 福利方案的正常流程之外或中期。因此，儘管我們曾希望一些支付方和藥品福利管理機構能夠迅速將低價的 Repatha 添加到 Medicare Part D 藥品目錄中，並收取固定的共同支付費用，但這種情況並沒有發生。因此，我們樂觀地認為，隨著 2020 年 Medicare Part D 處方集福利年度的到來，我們將能夠顯著改善 Repatha 在 Medicare Part D 固定共付額清單上的排名，我們將在第四季度知道結果。

Great. And in terms of dosing in colorectal cancer beyond 960 milligrams, as I mentioned, we've enrolled right now a fair number of patients at that target dose. I think we'll look for insights from that cohort. It remains early in this development program. And with these drugs, of course, there is often tweaking of dosing and scheduling as you go along. But I would say that, at this point, 960 is our target dose. We will assess emerging data to see if we want to explore some other doses and schedules going forward.

偉大的。至於大腸直腸癌的劑量超過 960 毫克，正如我所提到的，我們目前已經招募了相當數量的患者接受該目標劑量。我認為我們會從那批人身上尋找一些見解。該開發案仍處於早期階段。當然，對於這些藥物，劑量和用藥時間通常需要根據實際情況進行調整。但我認為，目前960是我們的目標劑量。我們將評估新出現的數據，看看是否要探索其他劑量和給藥方案。

Our next question is from the line of Do Kim from BMO Capital Markets.

我們的下一個問題來自 BMO 資本市場的 Do Kim。

Just on the acquisition of Nuevolution, I was hoping you could provide some context on the decision to acquire and bring the platform in-house versus just licensing additional programs or buying another company with assets in the clinical stage? And what is the plan for their existing collaboration and the potential for new ones?

關於收購 Nuevolution，我希望您能解釋一下，為什麼選擇收購並將平台納入公司內部，而不是僅僅授權其他程序或收購另一家擁有處於臨床階段資產的公司？他們現有的合作計畫是什麼？未來是否有可能開展新的合作？

Yes, sure. I'll be happy to address that. So the Nuevolution acquisition actually grew out of a partnership that we had with them on programs that was quite successful. And when we looked at the breadth of expansion of that potential partnership, we thought that simply bringing them onboard made sense. In terms of their existing obligations, obviously, those are things that we will fulfill as we move forward. I would point out that we plan on and have established them as Amgen Research Copenhagen, and they will remain a stand-alone Amgen research site going forward. And we're incredibly enthusiastic about what we think is world-leading technology.

當然可以。我很樂意回答這個問題。因此，對 Nuevolution 的收購實際上源於我們與他們在一些專案上的合作，而這些專案非常成功。當我們審視這種潛在合作關係的擴展範圍時，我們認為讓他們加入是明智之舉。至於他們現有的義務，顯然，這些都是我們將在前進的過程中履行的。我想指出，我們計劃並已經將它們設立為安進哥本哈根研究中心，它們將作為安進獨立的研究中心繼續運作。我們對這項我們認為是世界領先的技術感到無比興奮。

Ian, let's take one last question, if there is one. After which, Bob will make a few closing comments, and then I'll close the call.

伊恩，我們來回答最後一個問題，如果有的話。之後，鮑伯會做一些總結發言，然後我會結束通話。

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

最後一個問題來自瑞穗證券的 Salim Syed。

Bob, I appreciate the commentary on M&A, I just had a follow-up on it. And I totally understand you're looking at how to grow the top line both internally and externally. But I guess what would you say to what are the gating factors? And then why haven't you done more M&A this year? Is it the science that you're not seeing, something that you want, or is it valuation? Is it FTC? Or do you truly believe that the highest ROI you can get right now is just buying back your own stock?

鮑勃，我很感謝你對併購的評論，我剛剛還有後續問題。我完全理解您正在考慮如何從內部和外部兩個方面提高營收。但我想問，您認為有哪些限制？那麼，為什麼你們今年沒有進行更多併購活動呢？你看到的是科學本身，還是你想要的東西，又或者是估值問題？是聯邦貿易委員會（FTC）嗎？還是你真的認為目前能獲得最高投資報酬率的方法就是回購自己的股票？

I think, Salim, we look at a range of opportunities. I think valuations have been stretched. It's been hard for us in some of the things that we liked to find transactions at prices that we think can earn a return for our shareholders. It's easy to earn a return for the target shareholders where we're keen and focused on trying to earn the return for our shareholders. So that's clearly been a consideration for us more than anything else, I think. But again, we continue to look for opportunities and fully expect that by being disciplined, we'll find ones that enable us to win for our shareholders and to invest in programs that can help us grow the company. So we're optimistic, we're pleased that we have the resources to be able to move forward, and money is not burning a hole in our pocket.

我認為，薩利姆，我們考慮的是一系列機會。我認為估值過高了。在我們喜歡的一些領域，我們很難找到價格合適的交易，因為我們認為這些交易能夠為股東帶來回報。我們致力於為目標股東創造回報，因此很容易為目標股東帶來回報。所以，我認為這顯然是我們最主要的考慮因素。但是，我們將繼續尋找機會，並完全相信，透過保持自律，我們將找到能夠為股東帶來勝利並投資於能夠幫助公司發展的專案的機會。所以我們很樂觀，很高興我們有足夠的資源向前邁進，我們的資金並不緊張。

Okay. So with that, Bob, do you want to make some closing comments?

好的。那麼，鮑勃，你還有什麼要補充的嗎？

Sure. Let me just end where I started, which is to say that we're pleased with our performers through the first half of the year and excited about our long-term prospects, which we think are driven, in large part, by what we think will be unit volume gains across a number of our important products and excited as well about our innovative pipeline and the prospect of branded biosimilars adding to our top line. And let me just, finally, thank our Amgen staff around the world who continue to help us deliver on our mission to serve patients while remaining focused on driving value for our shareholders.

當然。最後我想回到我開頭說的，那就是我們對上半年業績感到滿意，並對長期前景感到興奮。我們認為，這在很大程度上得益於我們一些重要產品的銷售成長，同時我們也對我們的創新產品線以及品牌生物相似藥有望增加收入的前景感到興奮。最後，我要感謝安進全球的員工，感謝他們繼續幫助我們履行服務患者的使命，同時專注於為股東創造價值。

Excellent. Thanks, Bob, and thanks to all of you for your participation. If you have any follow-on comments, questions, if you would like to continue the discussion, feel free to call us. The IR team will be standing by for several hours. Thanks again.

出色的。謝謝你，鮑勃，也謝謝各位的參與。如果您有任何後續意見、問題，或想繼續討論，請隨時致電我們。IR團隊將待命數小時。再次感謝。

Ladies and gentlemen, this does conclude today's conference. We thank you greatly for your participation. You may now disconnect.

女士們、先生們，今天的會議到此結束。非常感謝您的參與。您現在可以斷開連線了。