美國安進 (AMGN) 2019 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • My name is Ian, and I will be your conference facilitator today for Amgen's Fourth Quarter 2019 Financial Results Conference Call. (Operator Instructions)

    我叫伊恩,今天我將擔任安進 2019 年第四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。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Okay. Thank you, Ian, and good afternoon, everybody. Thanks for joining us today.

    好的。謝謝你,伊恩,大家下午好。感謝您今天收看我們的節目。

  • So 2019 was a year that we made significant progress on our strategy and took steps that positioned us well for what will surely be a special year in 2020 as we celebrate our 40th anniversary. What better gift to celebrate this important milestone than to get back to revenue growth.

    因此,2019 年我們在策略方面取得了重大進展,並採取了一系列措施,為 2020 年這個特殊的一年做好了充分準備,因為 2020 年我們將慶祝公司成立 40 週年。慶祝這一重要里程碑的最佳禮物莫過於恢復營收成長。

  • So our Chairman and CEO, Bob Bradway, will lead the discussion today. We are also joined today by our new CFO, Peter Griffith, who will provide a financial update on our results for Q4 and full year 2019, and provide guidance for 2020. Our Head of Global Commercial Operations, Murdo Gordon, will then review our product performance; followed by our head of R&D, Dave Reese, who will provide a pipeline update.

    因此,我們的董事長兼執行長鮑勃·布拉德韋將主持今天的討論。今天,我們也迎來了新任財務長彼得·格里菲斯,他將介紹我們 2019 年第四季和全年的財務業績,並對 2020 年的業績做出展望。接下來,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 將提供產品線更新資訊。

  • We will use slides to guide our discussion today, and you should have received the link separately. We will also 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 results -- actual results to differ materially.

    今天我們將使用幻燈片來引導討論,您應該已經單獨收到連結了。在今天的演示中,我們還將使用非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的業績與實際業績有重大差異的因素。

  • 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?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Thank you, Arvind, and good afternoon, everyone, and thank you for joining our call.

    好的。謝謝你,Arvind,大家下午好,謝謝各位參加我們的電話會議。

  • Heading into 2020, we feel ready for the challenges of a new year, and we're feeling encouraged by the progress we made in 2019. Once again, this past year, we met and exceeded our financial targets. We advanced key elements of our long-term growth strategy, and we serve more patients around the world with our growing portfolio of medicines.

    展望 2020 年,我們感到已準備好迎接新一年的挑戰,並且我們對 2019 年的進展感到鼓舞。去年,我們再次達到並超額完成了財務目標。我們推進了長期成長策略的關鍵要素,並透過不斷增長的藥品組合為世界各地更多患者提供服務。

  • 2019 was the transition year we had long been preparing for as many of our off-patent legacy products faced new competition. I believe we managed this transition well, as evidenced by the fact that we delivered earnings growth in 2019 and will return to top line growth in 2020.

    2019 年是我們長期以來一直在準備的過渡年,因為我們許多已過專利期的傳統產品面臨新的競爭。我相信我們已經很好地完成了這項轉型,2019 年我們實現了獲利成長,2020 年也將恢復營收成長,這便是最好的證明。

  • In 2019, drug prices in the U.S. actually fell overall for the first time since 1974. In anticipation of this challenge, we repositioned the company's expense base and embedded productivity initiatives over the past several years that are serving us well. In addition, we reshaped our product portfolio, committing to medicines that can deliver growth for us, primarily through volume increases rather than price increases, products like Repatha, Aimovig, Prolia, EVENITY and most recently, Otezla.

    2019年,美國藥品價格總體上出現了自1974年以來的首次下降。為了應對這項挑戰,我們在過去幾年中重新調整了公司的費用結構,並實施了多項提高生產力的舉措,這些舉措目前都對我們大有裨益。此外,我們重新調整了產品組合,致力於能夠為我們帶來成長的藥品,主要透過增加銷售量而不是提高價格來實現成長,例如 Repatha、Aimovig、Prolia、EVENITY 以及最近的 Otezla。

  • In 2019, we delivered 3% volume growth globally and 19% volume growth outside the United States. We're seeing especially strong performance in our Asia Pacific region, albeit from a small base. Over the next decade, we expect this region to account for as much as 25% of Amgen's growth. For the full year in 2019, volume in the region grew 62%. Over 2/3 of that growth came from our joint venture with Astellas in Japan, the world's third-largest pharmaceutical market. Just a reminder that this collaboration reverts fully to Amgen on April 1, enabling us to do business in Japan through a wholly owned subsidiary for the first time. Our strategic collaboration in China with BeiGene closed a few weeks ago, and we're excited by what our 2 companies can achieve together in the world's second-largest pharmaceutical market.

    2019年,我們全球銷量成長了3%,美國以外地區的銷量成長了19%。儘管亞太地區的基數較小,但我們在該地區的業績表現尤其強勁。未來十年,我們預計該地區將佔安進公司成長的 25%。2019 年全年,該地區銷量成長了 62%。超過三分之二的成長來自我們與日本安斯泰來製藥的合資企業,日本是世界第三大藥品市場。再次提醒大家,這項合作將於 4 月 1 日完全回歸安進,這將使我們首次能夠透過全資子公司在日本開展業務。幾週前,我們與百濟神州在中國的策略合作正式結束,我們對兩家公司在世界第二大醫藥市場攜手取得的成就感到非常興奮。

  • 2019 was also a watershed year for us for our biosimilars business. We've delivered our first several biosimilars to market on time and on budget, and we believe we are in the early innings of what can be an important growth opportunity for us over time.

    2019 年對於我們的生物相似藥業務來說也是具有里程碑意義的一年。我們已經按時按預算將首批幾款生物相似藥推向市場,我們相信我們正處於一個重要的成長機會的早期階段。

  • Through the end of Q4, the business was already annualizing at over $1 billion, and we will add to our portfolio later this year with the launch of AVSOLA, our biosimilar to REMICADE. We also expect that AMGEVITA, our biosimilar to HUMIRA in Europe and other parts of the world, will benefit from our recent acquisition of Otezla.

    截至第四季末,該業務的年化收入已超過 10 億美元,我們將在今年稍後推出 AVSOLA,這是我們的 REMICADE 生物相似藥,從而進一步豐富我們的產品組合。我們也預計,我們在歐洲和世界其他地區銷售的 HUMIRA 生物相似藥 AMGEVITA 將受益於我們最近對 Otezla 的收購。

  • A key pillar of our growth strategy continues to be bringing to market first-in-class or best-in-class medicines that deliver a large effect size for patients suffering from serious illnesses. The world is growing older, wealthier and more urban, and these megatrends mean that the world will need more biopharmaceutical innovation, not less. We intend to be a leader in delivering that innovation.

    我們成長策略的關鍵支柱仍是向市場推出同類首創或同類最佳的藥物,這些藥物能為患有嚴重疾病的患者帶來顯著療效。世界人口老化、富裕化和城市化程度不斷提高,這些大趨勢意味著世界將需要更多的生物製藥創新,而不是更少。我們立志成為引領創新潮流的先鋒。

  • We expect several important data readouts from our pipeline in 2020. We expect data for AMG510, our KRAS G12C inhibitor; for tezepelumab in allergic and nonallergic asthma; for omecamtiv in heart failure; and for Otezla in mild to moderate psoriasis. In addition, we'd expect to generate some important data across our BiTE portfolio in 2020 as well, and Dave Reese will provide details on all of this shortly.

    我們預計 2020 年將從我們的數據管道中獲得幾項重要數據。我們期待獲得 AMG510(我們的 KRAS G12C 抑制劑)、tezepelumab(用於治療過敏性和非過敏性氣喘)、omecamtiv(用於治療心臟衰竭)以及 Otezla(用於治療輕度至中度乾癬)的數據。此外,我們預計在 2020 年,我們的 BiTE 投資組合也將產生一些重要數據,Dave Reese 很快就會提供有關所有這些的詳細資訊。

  • Last year, we also expanded our commitment to discovery research, strengthening our world-leading human genetics capabilities through a number of collaborations while adding large-scale proteomic data as well. We remain excited about how our approach is enabling us to identify and pursue new targets and the patients who stand to benefit most from them.

    去年,我們也擴大了對探索性研究的投入,透過一系列合作加強了我們世界領先的人類遺傳學能力,同時也增加了大規模蛋白質體學數據。我們對我們的方法能夠幫助我們識別和追求新的目標以及最有可能從中受益的患者感到興奮。

  • Everything we see in our company and across the industry continues to make us feel that we're living in an incredible age of biotechnology innovation. Across diseases, we're seeing more and more reasons to be optimistic about the next breakthrough for patients. At the same time, we know that governments and individuals are struggling with how to pay for these breakthroughs. We accept the responsibility to be part of the solution, both in advancing innovation that really matters and in providing innovative ways for patients to get access to it. In an election year, there's bound to be much discussion about health care, and we look forward to engaging with other stakeholders to promote market-based solutions that promote innovative medicines and affordable access to them.

    我們公司以及整個產業所看到的一切都讓我們覺得,我們正生活在一個令人難以置信的生物技術創新時代。在各種疾病領域,我們看到越來越多的理由對患者的下一個突破保持樂觀。同時,我們也知道各國政府和個人都在努力解決如何為這些突破性進展支付費用的問題。我們有責任成為解決方案的一部分,既要推動真正重要的創新,也要為患者提供獲得創新療法的途徑。在選舉年,醫療保健問題必然會引發許多討論,我們期待與其他利益相關者合作,推廣以市場為基礎的解決方案,從而促進創新藥物的研發和民眾能夠負擔得起這些藥物。

  • Just as we recognize that we need to be a constructive stakeholder to help sustain the robust ecosystem that exists for biotechnology innovation in the U.S., so too do we recognize and accept the need to be part of the process of addressing other environmental, social and governance matters that are of concern in our communities today. To that end, several years ago, we set targets for reducing our carbon emissions and water consumption by the year 2020. Having hit those targets in 2019, a year earlier than planned, we are now developing a next set of goals that we will share later this year. These goals will include a further commitment to our next-generation manufacturing technologies, which have a much smaller environmental footprint than traditional biologics manufacturing and enable us to operate at a lower cost, too.

    正如我們認識到我們需要成為建設性的利益相關者,以幫助維持美國生物技術創新的強大生態系統一樣,我們也認識到並接受需要參與解決當今社區關注的其他環境、社會和治理問題的進程。為此,幾年前,我們制定了 2020 年減少碳排放和用水量的目標。2019 年,我們提前一年實現了這些目標,現在我們正在製定下一批目標,我們將在今年稍後公佈這些目標。這些目標將包括進一步致力於我們的下一代製造技術,這些技術比傳統的生物製劑製造對環境的影響要小得多,也能讓我們以更低的成本運作。

  • Now let me turn over the call to our new CFO, Peter Griffith. You'll recall that Peter joined us in October, and he'll take you through the details of our performance in 2019 and our outlook for 2020. Peter, over to you.

    現在讓我把電話交給我們的新任財務長彼得‧格里菲斯。您可能還記得,Peter 於 10 月加入我們,他將帶您了解我們 2019 年的表現以及我們對 2020 年的展望。彼得,該你了。

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Thanks, Bob.

    謝謝你,鮑伯。

  • Let me begin by saying how happy I am to join Amgen at such an exciting time in the company's 40-year history. I also want to take a moment to thank David Meline, the Amgen team as well as many of you on the call who have helped me transition into the role. Over the last several months, I've enjoyed meeting many of our investors as well as members of the analyst community, and I look forward to the continued dialogue and engagement.

    首先,我非常高興能在安進公司40年發展歷程中如此令人興奮的時刻加入公司。我還要藉此機會感謝大衛梅林、安進團隊以及在座的各位,感謝你們幫助我順利過渡到這個角色。在過去的幾個月裡,我很高興能與許多投資者以及分析師們見面,我期待著繼續與他們進行對話和交流。

  • Now let's turn to the fourth quarter financial results on Page 6 of the slide deck. Revenues at $6.2 billion decreased 1% year-over-year in the fourth quarter. In the quarter, we saw worldwide product sales declined 2% to $5.9 billion as our portfolio transitioned with declines in our mature products, substantially offset by our growth and launch products. We are particularly encouraged by the strong 21% volume-driven growth from our ex U.S. markets, which gives us confidence as we continue our global expansion, including into China, which will also benefit from our collaboration with BeiGene, which closed earlier this month.

    現在讓我們來看看投影片第 6 頁的第四季財務表現。第四季營收為 62 億美元,年減 1%。本季度,由於產品組合轉型,成熟產品銷售額下降,全球產品銷售額下降 2% 至 59 億美元,但成長型和上市產品的銷售額大幅抵消了這一影響。我們尤其受到美國以外市場銷量強勁成長 21% 的鼓舞,這讓我們更有信心繼續進行全球擴張,包括進軍中國市場。中國市場也將受益於我們與百濟神州的合作,該合作已於本月初完成。

  • Foreign exchange had a 1% negative impact to fourth quarter worldwide sales on a year-over-year basis. Other revenues at $316 million were up $87 million versus Q4 2018.

    外匯波動對第四季度全球銷售額較去年同期產生了 1% 的負面影響。其他收入為 3.16 億美元,比 2018 年第四季增加了 8,700 萬美元。

  • Our Q4 non-GAAP operating income at $2.6 billion decreased 4% from prior year. Non-GAAP operating margin was 44.6% for the quarter compared to 45.3% in Q4 of 2018. As previously indicated, our operating expenses reflected the typical underlying fourth quarter pattern, increased investment in our rapidly evolving oncology pipeline portfolio,and additional operating expenses associated with the Otezla acquisition, which closed in Q4. These increases were partially offset by continued favorable expense impacts from our productivity initiatives,across all operating expense categories.

    我們第四季非GAAP營業收入為26億美元,比去年同期下降4%。本季非GAAP營業利益率為44.6%,而2018年第四季為45.3%。如前所述,我們的營運費用反映了典型的第四季度基本模式,增加了對我們快速發展的腫瘤產品線組合的投資,以及與第四季度完成的 Otezla 收購相關的額外營運費用。這些成長被我們各項生產力提升措施帶來的持續有利的費用影響部分抵消,這些影響涵蓋所有營運費用類別。

  • Other income and expenses were a net $65 million expense in Q4, representing $132 million of year-over-year favorability. This favorability was driven by gains generated from liquidating bond investments to fund the Otezla and BeiGene transaction and favorable market value fluctuations of publicly traded securities held in our Ventures portfolio, partially offset by lower interest income due to reduced cash balances.

    第四季其他收入和支出淨額為 6,500 萬美元,較上年同期成長 1.32 億美元。這項利多因素主要源自於清算債券投資所得收益,用於資助 Otezla 和百濟神州的交易,以及我們創投投資組合中公開交易證券的有利市場價值波動,但部分被現金餘額減少導致的利息收入下降所抵銷。

  • The non-GAAP tax rate was 14.9% for the quarter, a 1.6-point increase versus Q4 2018. And primarily due to a onetime prior year tax benefit associated with intercompany sales under U.S. corporate tax reform.

    本季非GAAP稅率為14.9%,比2018年第四季上升了1.6個百分點。主要原因是由於美國企業稅制改革中與公司間銷售相關的上一年度一次性稅優惠。

  • Non-GAAP net income was $2.2 billion. And non-GAAP earnings per share increased 6% year-over-year for the fourth quarter, supported by a 7% reduction in share count versus Q4 2018.

    非GAAP淨利為22億美元。第四季非GAAP每股盈餘年增6%,這得益於與2018年第四季相比,股份數量減少了7%。

  • Next, I will review our 2019 full year results on Page 7 of the presentation. Our 2019 full year revenues decreased 2% to $23.4 billion, while our non-GAAP earnings per share grew 3% to $14.82 per share. For the full year, we saw a 1% decline in worldwide product sales to $22.2 billion. Volume growth in markets outside the U.S. was 19% year-over-year. Other revenues at $1.2 billion were down $56 million year-over-year.

    接下來,我將在簡報的第 7 頁回顧我們 2019 年全年業績。2019 年全年營收下降 2% 至 234 億美元,而非 GAAP 每股收益成長 3% 至每股 14.82 美元。全年來看,全球產品銷售額下降了 1%,至 222 億美元。美國以外市場的銷量較去年同期成長 19%。其他收入為 12 億美元,年減 5,600 萬美元。

  • For the full year, non-GAAP operating income at $11.2 billion decreased 6% from the prior year. And our non-GAAP operating margin was 50.2% for the year, down from 52.6% in 2018. In total, non-GAAP operating expenses increased 3% year-over-year to $12.2 billion. This growth was driven by research and development, research and development investments, launch product support and the addition of Otezla to our business, partially offset by our productivity program.

    全年非GAAP營業收入為112億美元,較上年下降6%。本年度非GAAP營業利益率為50.2%,低於2018年的52.6%。總計,非GAAP營運費用年增3%,達到122億美元。這一成長主要得益於研發、研發投資、產品上市支援以及將 Otezla 納入我們的業務,但部分被我們的生產力提升計劃所抵消。

  • Other income and expenses were favorable by $250 million on a year-over-year basis due primarily to gains in 2019 from liquidating bonds to fund the Otezla and BeiGene transactions, partially offset by lower interest income resulting from reduced cash balances.

    其他收入和支出比去年同期減少了 2.5 億美元,這主要是由於 2019 年透過清算債券為 Otezla 和 BeiGene 的交易提供資金而獲得的收益,但部分被現金餘額減少導致的利息收入下降所抵消。

  • The non-GAAP tax rate was 15% for the full year, up 1.5 points versus 2018, again, primarily due to a onetime prior year tax benefit associated with intercompany sales under U.S. corporate tax reform.

    全年非GAAP稅率為15%,較2018年上漲1.5個百分點,主要是由於美國企業稅制改革下與公司間銷售相關的上一年一次性稅優惠。

  • Turning next to cash flow and the balance sheet on Page 8. For the full year 2019, Amgen continued to generate strong cash flow, reflecting a diversified portfolio of products, coupled with an industry-leading cost structure. Free cash flow was $8.5 billion in 2019 versus $10.6 billion in 2018, the decline driven by lower net income, timing of working capital and an advanced tax deposit. In 2019, we returned a total of $11.1 billion to shareholders through dividend payments totaling $3.5 billion and $7.6 billion used to repurchase 40.2 million shares at an average of $190 per share. And this follows the $21.4 billion return of capital to shareholders in 2018.

    接下來請看第 8 頁的現金流量和資產負債表。 2019 年全年,安進持續產生強勁的現金流,這反映了其多元化的產品組合以及領先業界的成本結構。2019 年自由現金流為 85 億美元,而 2018 年為 106 億美元,下降的原因是淨收入減少、營運資本的時間安排以及預繳稅款。2019 年,我們透過股息支付向股東返還了總計 111 億美元,其中 35 億美元用於派發股息,76 億美元用於以平均每股 190 美元的價格回購 4,020 萬股股票。此前,該公司在 2018 年向股東返還了 214 億美元的資本。

  • Cash and investments totaled $8.9 billion at the end of 2019, a decrease of $20.4 billion from the end of 2018. This decrease was primarily driven by the Otezla transaction, cash returned to shareholders in the form of dividends and share repurchases as well as debt repayment, all partially offset by free cash flow generated during the period.

    截至 2019 年底,現金和投資總額為 89 億美元,比 2018 年底減少了 204 億美元。這一下降主要是由於 Otezla 交易、以股息和股票回購形式返還給股東的現金以及償還債務所致,但所有這些都被該期間產生的自由現金流部分抵消。

  • Debt outstanding at year-end totaled $29.9 billion and carries a weighted average interest rate of 3.7% and with an average maturity of 12 years.

    截至年末,未償債務總額為 299 億美元,加權平均利率為 3.7%,平均期限為 12 年。

  • Now turning to the outlook for the business for 2020 on Page 9. 2020 will be another important year for Amgen as we continue to invest in the pipeline to generate innovative and differentiated molecules, build out the global business and support the growth of our new products. As previously discussed, in anticipation of this opportunity and continued downward pressure on net prices, we developed a productivity capability to enable us to fully invest from a position of strength.

    現在讓我們來看看 2020 年的業務展望(見第 9 頁)。 2020 年對安進來說將是另一個重要的年份,我們將繼續投資研發管線,以產生創新和差異化的分子,拓展全球業務,並支持我們新產品的成長。正如之前討論過的,為了抓住這一機會並應對淨價持續下行的壓力,我們發展了生產力,使我們能夠從優勢地位出發進行充分投資。

  • Our 2020 revenue guidance is $25.0 billion to $25.6 billion, and our non-GAAP earnings per share guidance is $14.85 per share to $15.60 per share. GAAP earnings per share guidance is $10.85 per share to $11.65 per share, which diverges from non-GAAP EPS, primarily due to the amortization of intangibles related to our Otezla acquisition. Our non-GAAP tax rate guidance is 13.5% to 14.5%. And once again, we expect capital expenditures of approximately $700 million this year, including our industry-leading, environmentally friendly, next-generation manufacturing facility in Rhode Island.

    我們對 2020 年的營收預期為 250 億美元至 256 億美元,非 GAAP 每股盈餘預期為 14.85 美元至 15.60 美元。GAAP每股收益預期為每股10.85美元至11.65美元,與非GAAP每股收益預期有所不同,主要是由於與我們收購Otezla相關的無形資產攤銷所致。我們的非GAAP稅率預期為13.5%至14.5%。我們預計今年資本支出將達到約 7 億美元,其中包括我們在羅德島州建造的行業領先、環保的下一代製造工廠。

  • Let me mention several key assumptions embedded in our guidance. First, our revenue guidance range reflects continued strong worldwide growth from products, including Prolia, EVENITY, Repatha, Aimovig, Otezla and our biosimilar portfolio. At the same time, we expect increasing competition against our filgrastim and ESA franchises as well as Sensipar.

    讓我提一下我們指南中包含的幾個關鍵假設。首先,我們的收入預期範圍反映了包括 Prolia、EVENITY、Repatha、Aimovig、Otezla 和我們的生物相似藥產品組合在內的產品在全球範圍內的持續強勁增長。同時,我們預計我們的非格司亭和 ESA 產品線以及 Sensipar 將面臨日益激烈的競爭。

  • Next, with regard to net selling prices, we experienced a 5% decline globally in 2019. For 2020, we expect to again experience low to middle single-digit declines globally. We expect our volume growth to more than offset the net price decline. Overall, as previously stated, excluding Otezla, we expect our base business to be stable in 2020 on a year-over-year basis.

    其次,就淨銷售價格而言,2019 年全球淨銷售價格下降了 5%。我們預計2020年全球經濟將再次出現個位數低至中等幅度的下滑。我們預計銷售成長將足以抵銷淨價下降的影響。總體而言,如前所述,除 Otezla 外,我們預計 2020 年我們的基礎業務將保持穩定,與去年同期相比。

  • As you model revenue in 2020, note that historically, the first quarter represents the lowest product sales quarter of the year. As a percent of the full year, product sales for the first quarter should look similar to the percentage we saw in Q1 of 2019. Murdo will explain further in his remarks.

    在對 2020 年的收入進行建模時,請注意,從歷史數據來看,第一季是一年中產品銷售額最低的季度。第一季產品銷售額佔全年銷售額的百分比應該與 2019 年第一季的百分比相似。默多將在演講中進一步解釋。

  • With respect to other revenue, we expect about $1.1 billion for the full year 2020 as we anticipate increased competition against our royalty products portfolio.

    至於其他收入,我們預計 2020 年全年收入約為 11 億美元,因為我們預計我們的特許權使用費產品組合將面臨更大的競爭。

  • From an operating expense perspective, overall, we expect 2020 total non-GAAP operating expenses to grow in the low double-digit percentage range year-over-year on an absolute basis. As previously communicated, we reiterate the following 3 assumptions: non-GAAP R&D investment to increase as we invest in our advancing innovative pipeline programs and new Otezla indications, partially offset by R&D recoveries received from our BeiGene collaboration; second, non-GAAP SG&A expense to increase due to the acquisition of Otezla as well as modest incremental investment in support of our base business as we continue to expand globally, including China and Japan, grow our biosimilars business and begin product launch preparation for our late-stage pipeline; non-GAAP cost of sales as a percent of product sales to be generally consistent with 2019.

    從營運費用角度來看,整體而言,我們預計 2020 年非 GAAP 營運費用總額將較去年同期成長,絕對值約為兩位數百分比。如同先前所溝通的,我們重申以下三個假設:第一,由於我們投資於推進創新管線項目和 Otezla 的新適應症,非 GAAP 研發投資將增加,部分將被從與百濟神州的合作中獲得的研發收益所抵消;第二,由於收購 Otezla 以及為支持我們基礎業務而進行的適度增量,非 GAAP銷售、管理及行政費用將增加,因為我們將繼續在全球擴張,包括中國和日本,發展我們的生物相似藥業務,並開始為後期管線的產品上市做準備;第三,非 GAAP 銷售成本佔產品銷售額的百分比將與 2019 年基本保持一致。

  • We expect all expense categories to continue to benefit from our productivity program. We anticipate non-GAAP other income and expense to be a net expense in a range between $1.2 billion and $1.4 billion. This is primarily driven by lower interest income as a result of cash used to fund the Otezla and BeiGene transactions as well as our 20.5% share of BeiGene's results based on current publicly available consensus estimates. I note that our 20.5% share of BeiGene's results will be booked 1 quarter in arrears in accordance with the equity method of accounting, and therefore, begins in Q2 2020.

    我們預計所有費用類別都將繼續受益於我們的生產力提升計畫。我們預計非GAAP其他收入和支出淨額將在12億美元至14億美元之間。這主要是由於用於支付 Otezla 和百濟神州交易的現金導致利息收入減少,以及根據目前公開的共識估計,我們應佔百濟神州 20.5% 的業績份額。我注意到,根據權益法會計核算,我們應佔百濟神州 20.5% 的業績份額將延遲一個季度入賬,因此,該份額從 2020 年第二季度開始計入。

  • As you know, on April 1, 2020, Amgen will purchase the 49% of shares in Amgen Astellas biopharma that are held by Astellas for a nominal fee, making the company a wholly owned Amgen subsidiary. First, let me say how excited we are about this transition as it marks the achievement of a long-term strategic objective. We look forward to further leveraging this platform as we seek to bring Amgen's new medicines to patients in the third-largest pharmaceutical market. From a financial perspective, we anticipate limited near-term financial impact resulting from this transition.

    如您所知,2020 年 4 月 1 日,安進將以像徵性費用收購安斯泰來生物製藥公司持有的 49% 股份,使該公司成為安進的全資子公司。首先,我想表達我們對這項轉變的興奮之情,因為它標誌著我們長期策略目標的實現。我們期待進一步利用這個平台,將安進的新藥帶給全球第三大藥品市場的患者。從財務角度來看,我們預期此次轉型在短期內不會對財務造成太大影響。

  • Now with regard to capital deployment, our actions will continue to reflect the following principles. First, we will invest in our business to expand our pipeline of innovative medicines and to seek to drive long-term volume growth globally. We will also invest in prudent external business development opportunities.

    至於資本部署方面,我們的行動將繼續體現以下原則。首先,我們將投資我們的業務,以擴大我們的創新藥物研發管線,並尋求在全球範圍內推動長期銷售成長。我們也將投資於審慎的外部業務拓展機會。

  • Second, we remain committed to returning capital to shareholders in the form of growing dividends, including the 10% increase in the first quarter of 2020 to $1.60 per share, as well as continued share repurchases. We will continue to take an opportunistic view towards the timing of share repurchases within '20. We expect share repurchases within a range of $3 billion to $5 billion and have an authorization outstanding in the amount of $6.5 billion.

    其次,我們將繼續致力於以不斷增長的股息形式向股東返還資本,包括 2020 年第一季股息增長 10% 至每股 1.60 美元,以及持續的股票回購。我們將繼續以機會主義的態度看待 2020 年內的股票回購時機。我們預計股票回購金額將在 30 億美元至 50 億美元之間,目前已授權回購金額為 65 億美元。

  • And third, we remain committed to maintaining an optimal capital structure in order to minimize our weighted average cost of capital and retain our investment-grade rating. Consistent with our usual practice, our guidance today does not include the impact of potential external business development activities.

    第三,我們將繼續致力於維持最佳資本結構,以最大限度地降低加權平均資本成本,並維持投資等級。與我們一貫的做法一致,我們今天的指導意見不包括潛在的外部業務發展活動的影響。

  • So in summary, we delivered another year of strong financial results in 2019, and we remain confident in the outlook for Amgen's success in 2020 and beyond.

    總而言之,我們在 2019 年又取得了強勁的財務業績,我們對安進在 2020 年及以後的成功前景仍然充滿信心。

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

    財務更新到此結束。現在我將把通話轉給默多。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks, Peter, and good afternoon, everyone. I'll take a few minutes to reflect on 2019 and then review Q4 in greater detail.

    謝謝你,彼得,大家下午好。我將花幾分鐘時間回顧2019年,然後更詳細地回顧第四季。

  • In the 40 years since incorporation, Amgen's product portfolio and geographical footprint has changed dramatically. On our 40th anniversary, we reflect on the pioneering, innovative spirit of our early Amgen employees that transformed the treatment of disease. Our mission to serve patients remains unchanged, and it motivates us every single day. Our accomplishments on behalf of patients in 2019 give us further confidence about our future as we enter 2020.

    自成立以來的 40 年間,安進的產品組合和地理佈局發生了巨大變化。值此安進 40 週年之際,我們回顧了安進早期員工的開拓創新精神,正是這種精神改變了疾病的治療方式。我們服務患者的使命始終未變,激勵我們每一天。2019 年我們在為病人所取得的成就,讓我們對 2020 年的未來更有信心。

  • To summarize 2019, for the full year, we grew volume by 3%. The growing proportion of our portfolio posted 35% year-over-year volume increases. This portfolio is diverse and includes products such as Prolia, EVENITY, Repatha, Aimovig, Otezla, AMGEVITA, our 6 hematology and oncology brands as well as MVASI and KANJINTI.

    總結 2019 年,全年銷量成長了 3%。我們投資組合中佔比不斷增長的部分實現了同比增長 35%。產品組合豐富多樣,包括 Prolia、EVENITY、Repatha、Aimovig、Otezla、AMGEVITA、我們的 6 個血液學和腫瘤學品牌以及 MVASI 和 KANJINTI 等產品。

  • Finally, our international business contributed 19% volume growth in 2019. Notably, year-over-year revenues for our businesses in China and Japan grew nearly eightfold. These markets are long-term growth engines for Amgen. And our collaboration with BeiGene, along with our acquisition of Otezla will accelerate our expansions in the second and third largest pharmaceutical markets.

    最後,我們的國際業務在 2019 年實現了 19% 的銷售成長。值得注意的是,我們在中國和日本的業務收入比去年同期成長了近八倍。這些市場是安進公司的長期成長引擎。我們與百濟神州的合作,以及我們對 Otezla 的收購,將加速我們在第二大和第三大醫藥市場的擴張。

  • Now moving to fourth quarter results. Volumes grew by 3% year-over-year. In Q4, net selling prices declined 4% year-over-year, resulting in reported net sales declining by 2%. As Peter mentioned, we have a stable outlook for our base business for 2020. And with the addition of Otezla, we expect revenue growth this year despite projecting continued declines in net selling price on a portfolio basis.

    現在來看第四季業績。銷量較去年同期成長3%。第四季度,淨售價年減 4%,導致報告淨銷售額下降 2%。正如彼得所提到的,我們對2020年的基礎業務前景持穩定態度。隨著 Otezla 的加入,儘管我們預計今年投資組合的淨售價將繼續下降,但我們仍預計收入將實現成長。

  • Now getting into product details. Prolia delivered 15% growth year-over-year driven by higher volume from increasing rates of new patient growth and strong repeat injection rates. Recall that given twice-a-year dosing, Prolia experiences consistent seasonal trends.

    現在進入產品細節部分。Prolia 的表現年增 15%,這主要得益於新患者成長率的提高和強勁的重複注射率所帶來的業務量成長。請記住,由於每年需要服用兩次,Prolia 會出現穩定的季節性趨勢。

  • EVENITY posted $85 million in the fourth quarter, driven by strong uptake in both Japan and the U.S. Every year, worldwide, 8.9 million fractures occur due to osteoporosis. That's 1 fracture every 3 seconds, and only 20% of women who experienced a fracture are treated with a bone-building medicine. Given the underpenetrated nature of this market, we continue to focus on ensuring postmenopausal women receive appropriate screening, diagnosis and treatment. With Prolia and EVENITY, we have excellent treatment options to offer these patients.

    EVENITY第四季營收達8,500萬美元,主要得益於日本和美國市場的強勁成長。每年,全球有890萬例骨折是由骨質疏鬆症引起的。也就是說,每 3 秒鐘就有 1 例骨折,而只有 20% 的骨折女性接受了骨骼重建藥物治療。鑑於該市場滲透率較低,我們將繼續致力於確保停經後婦女獲得適當的篩檢、診斷和治療。Prolia 和 EVENITY 為我們提供了優秀的治療方案,可以為這些患者提供更好的治療選擇。

  • On to Repatha. Q4 sales grew by 26% year-over-year as we continue to be the leader in the PCSK9 class. Worldwide unit growth was 67% year-over-year. And new-to-brand U.S. prescriptions are steadily improving, growing at 61% year-over-year. We've taken significant steps and have made major progress in improving access and affordability for Repatha. We removed the original list price offering we, simplified and improved prescription approval rates and commercial plans, and we have increased the percentage of Medicare patients up to 70% that can access Repatha at a more affordable co-pay.

    接下來是瑞帕塔。第四季銷售額年增 26%,我們繼續保持 PCSK9 類藥物的領先地位。全球銷量較去年同期成長 67%。美國新藥處方量穩定成長,年增 61%。我們已採取重要措施,並在提高瑞百安(Repatha)的可及性和可負擔性方面取得了重大進展。我們取消了原先的標價,簡化並改進了處方審批率和商業計劃,我們已經將能夠以更實惠的共同支付方式獲得 Repatha 的 Medicare 患者比例提高了 70%。

  • Although the blended net price of Repatha in the U.S. declined in Q4 versus the previous year, net selling price was relatively stable sequentially. For 2020, we expect a step-down in Repatha's net selling price in Q1 based on our contracting to obtain broader access, with stabilization thereafter.

    儘管 Repatha 在美國的綜合淨價在第四季較去年同期有所下降,但淨售價較上季相對穩定。2020 年,我們預計 Repatha 的淨售價將在第一季因我們簽訂的擴大進入範圍的合約而有所下降,之後會趨於穩定。

  • Now on to Aimovig on Slide 16. On a year-over-year basis, volume grew 27%, while net sales grew 3%. And as a reminder, Q4 2018 benefited from $20 million of favorable changes in accounting estimates impacting the year-over-year comparison on a quarter-over-quarter basis. Unit volume grew 9%.

    接下來請看第 16 張投影片,內容是 Aimovig。與去年同期相比,銷量成長了 27%,淨銷售額成長了 3%。需要提醒的是,2018 年第四季受益於 2000 萬美元的會計估計有利變化,這影響了同比數據,轉而影響了環比數據。單位銷售成長9%。

  • To date, almost 300,000 patients have been prescribed aimovig by more than 33,000 prescribers. Considering that there are 4 million migraine patients in the U.S. who are eligible for CGRP treatment, Aimovig has significant potential remaining to penetrate this market. And we expect to drive volume growth over the course of 2020.

    迄今為止,已有超過 33,000 名醫生為近 30 萬名患者開立了 aimovig 處方。考慮到美國有 400 萬名偏頭痛患者符合 CGRP 治療條件,Aimovig 仍有很大的潛力打入這個市場。我們預計在 2020 年實現銷售成長。

  • Aimovig leads in both new-to-CGRP prescriptions and total prescriptions, which exited Q4 with a 48% TRx share. Aimovig has exceptional access with over 80% of prescriptions paid and over 92% of lives covered. As a result of this broader access, we expect net price to decline slightly on a full year basis for 2020 when compared to the full year 2019. Additionally, Q1 has lower sales in subsequent quarters due to the impact of benefit plan changes, insurance reverifications, and greater co-pay expenses as patients work through their deductibles.

    Aimovig 在 CGRP 新處方和總處方方面均處於領先地位,第四季度末的處方份額為 48%。Aimovig 的覆蓋範圍非常廣,超過 80% 的處方藥獲得報銷,超過 92% 的人獲得醫療覆蓋。由於市場准入範圍擴大,我們預計 2020 年全年淨價將比 2019 年全年略有下降。此外,由於福利計劃變更、保險重新核實以及患者在支付免賠額時自付額增加等因素的影響,第一季度的銷售額在隨後的幾個季度中有所下降。

  • We'll move to Parsabiv on Slide 17, which grew by 49% year-over-year in the fourth quarter. Independent and midsize dialysis providers already utilize Parsabiv for a majority of their calcimimetic patients, while FMC and DaVita continue to increase adoption.

    我們將在第 17 張投影片中介紹 Parsabiv,該公司第四季年增 49%。獨立和中型透析服務提供者已將 Parsabiv 用於其大部分擬鈣劑患者,而 FMC 和 DaVita 則繼續擴大其採用率。

  • Next, on to Otezla. With the help of the dedicated professionals that have joined our team from Celgene, we will continue to drive strong sales growth and launch potential new indications for Otezla. During the period since acquisition close, prescription momentum continued with 13% year-over-year growth. Our seamless integration efforts, combined with planned label and geographic expansion, gives us confidence in our ability to grow Otezla at low double-digit compound annual growth rate over the next 5 years. For the approximately 5 weeks post-closing in 2019, Otezla sales were $178 million. We expect first quarter sales to be proportionately lower than in the remaining quarters of the year. The quarterly pattern for Otezla in 2020 should approximate the historical pattern over the last number of years.

    接下來,前往奧特茲拉。在 Celgene 加入我們團隊的敬業專業人員的幫助下,我們將繼續推動強勁的銷售成長,並推出 Otezla 的潛在新適應症。自收購完成以來,處方藥銷售動能持續強勁,較去年同期成長 13%。我們無縫整合的努力,加上計劃中的品牌和地理擴張,使我們有信心在未來 5 年內實現 Otezla 低兩位數的複合年增長率。2019 年交易完成後的大約 5 週內,Otezla 的銷售額為 1.78 億美元。我們預計第一季的銷售額將比今年其他季度的銷售額低很多。2020 年 Otezla 的季度模式應該與過去幾年的歷史模式大致相同。

  • Moving on to Enbrel. Sales increased 2% year-over-year, driven by a [$66 million] favorable change in accounting estimates and increases in net selling price, partially offset by unit volume declines. Volume trends in 2020 are expected to be similar to those in 2019. As for net selling price, we project limited benefit in 2020 versus 2019 due to less favorable contract terms.

    接下來是恩利。銷售額年增 2%,主要得益於會計估計的有利變化(6,600 萬美元)和淨售價的上漲,但部分被銷量下降所抵銷。預計 2020 年的銷售趨勢將與 2019 年的銷售趨勢相似。至於淨售價,由於合約條款不太有利,我們預計 2020 年的收益與 2019 年相比有限。

  • With 2 highly complementary products targeting psoriasis and psoriatic arthritis, we see an opportunity to strengthen their positions in the market. More broadly, we're increasing our focus in inflammation through our broad portfolio, which includes our biosimilars, AMGEVITA and AVSOLA; our late-stage asset, tezepelumab; and a number of other earlier assets in the R&D pipeline.

    這兩款產品高度互補,分別針對乾癬和乾癬關節炎,我們看到了加強其市場地位的機會。更廣泛地說,我們正在透過我們廣泛的產品組合,增加對發炎領域的關注,其中包括我們的生物相似藥 AMGEVITA 和 AVSOLA;我們的後期資產 tezepelumab;以及研發管線中的許多其他早期資產。

  • Now to our hematology and oncology business, which is highly integrated with our oncology biosimilars that I'll discuss later. Our innovative portfolio of 6 brands, XGEVA, KYPROLIS, NPLATE, Vectibix, BLINCYTO and IMLYGIC collectively totaled $1.2 billion in the quarter, growing 10% year-over-year.

    現在來說說我們的血液學和腫瘤學業務,它與我們的腫瘤生物類似藥高度整合,我稍後會談到。我們旗下 6 個創新品牌(XGEVA、KYPROLIS、NPLATE、Vectibix、BLINCYTO 和 IMLYGIC)在本季總銷售額達 12 億美元,較去年同期成長 10%。

  • As for some of the larger brands within this portfolio, XGEVA grew 7% in Q4 year-over-year, driven by 4% volume growth. KYPROLIS grew 6% year-over-year, driven by volume led by a 12% increase in the U.S. -- in U.S. sales.

    至於該投資組合中的一些較大品牌,XGEVA 在第四季度同比增長 7%,其中銷量增長 4%。KYPROLIS 年成長 6%,主要得益於銷量成長,其中美國銷量成長 12%。

  • Nplate grew 15% year-over-year, driven by volume. Our investments in R&D for Nplate have resulted in 2 innovations. First, we recently launched a smaller presentation at 125 micrograms in support of Nplate's pediatric indication as the product is administered with weight-based dosing. This new presentation will also help to minimize general product wastage for ITP patients across all indications. Second, Nplate received approval in October for the treatment of early ITP, which gives us the chance to serve patients earlier in the course of their disease and provides the opportunity for treatment-free remission.

    受銷量推動,Nplate年增15%。我們在Nplate的研發投入已經產生了2項創新成果。首先,我們最近推出了一種劑量較小的產品,規格為 125 微克,以支持 Nplate 的兒科適應症,因為該產品是根據體重進行給藥的。這種新的給藥方式也有助於最大限度地減少 ITP 患者在所有適應症中的產品浪費。其次,Nplate 於 10 月獲準用於治療早期 ITP,這讓我們有機會在疾病早期階段為患者提供服務,並提供了無需治療即可緩解病情的機會。

  • Now on to our more mature brands in Q4. Neulasta sales declined 43% year-over-year with a 42% decline in the U.S. Recall that Q4 of 2018 benefited from a $55 million BARDA order, which did not repeat in Q4 of 2019. Coinciding with the emergence of U.S. biosimilar competition, the most recent CMS published ASP for Neulasta reflects a 10% reduction. Bear in mind that ASP is calculated 2 quarters in arrears.

    接下來,讓我們來看看第四季我們更成熟的品牌。Neulasta 的銷售額年減了 43%,其中美國市場下降了 42%。回想一下,2018 年第四季受益於 BARDA 的一筆 5,500 萬美元的訂單,但 2019 年第四季並未再次獲得該訂單。隨著美國生物相似藥競爭的出現,美國醫療保險和醫療補助服務中心 (CMS) 最近公佈的 Neulasta 平均銷售價格 (ASP) 下降了 10%。請注意,平均售價是滯後兩季計算的。

  • On a volume basis, in Q4, U.S. Neulasta retained an exit share of 74% of the long-acting segment, with Onpro holding an exit share of 55%. We're encouraged by Onpro's durability, demonstrating confidence that our customers have in the reliability and quality of our supply, along with our broader customer services. We now face a third biosimilar competitor in the U.S., and other potential competitors remain in development. As you model Neulasta sales for the first quarter, recall that Q1 2019 benefited from a $98 million BARDA order that we do not project to recur in 2020.

    按銷量計算,第四季度,美國 Neulasta 保持了長效藥物市場 74% 的市場份額,而 Onpro 保持了 55% 的市場份額。Onpro 的耐用性令我們倍感鼓舞,這表明我們的客戶對我們供貨的可靠性和品質以及我們更廣泛的客戶服務充滿信心。現在,我們在美國面臨第三個生物相似藥競爭對手,其他潛在的競爭對手仍在研發中。在模擬 Neulasta 第一季的銷售額時,請記住,2019 年第一季受益於 BARDA 9,800 萬美元的訂單,我們預計 2020 年不會再有該訂單。

  • Finally, outside the U.S., sales declined 48% in Q4, and we expect those trends to continue.

    最後,在美國以外,第四季銷售額下降了 48%,我們預計這種趨勢還會持續。

  • Switching to nephrology. Starting on Slide 25, Q4 EPOGEN sales declined 20%, primarily due to lower net selling price from our contractual commitment with DaVita, which calls for a further price reduction in 2020. Meanwhile, Aranesp declined 10% year-over-year, driven by lower volume due to increased competition.

    轉行做腎臟科醫生。從第 25 頁開始,第四季度 EPOGEN 銷售額下降了 20%,主要是由於我們與 DaVita 的合約承諾導致淨售價降低,該合約要求在 2020 年進一步降價。同時,受競爭加劇導致銷售下降的影響,Aranesp 年減了 10%。

  • Regarding SENSIPAR, recall that in the U.S., there were several at-risk generic launches in 2019 that resulted in year-over-year sales declining 76% to $107 million in the quarter. In 2020, supplemental patent protection certificates for cinacalcet expire in France, Germany, Italy, Spain and the United Kingdom, which will likely result in a significant decline in ex U.S. sales in 2020.

    關於 SENSIPAR,需要注意的是,2019 年美國有幾款仿製藥上市,導致該季度銷售額年減 76%,至 1.07 億美元。2020 年,西那卡塞在法國、德國、義大利、西班牙和英國的補充專利保護證書到期,可能會導致 2020 年美國以外的銷售額大幅下降。

  • I'll close the product section with our biosimilar portfolio, which is highly integrated with our innovative business throughout the company. As examples, a majority of these products were made with the same manufacturing network as our innovative brands. We also leverage the same supply chain for distribution. And on the commercial side, we continue to identify synergies in commercializing our biosimilars alongside our innovative products, making it a highly efficient selling model and allowing us to rapidly apply learnings across our portfolio.

    最後,我將介紹我們的生物相似藥產品組合,該產品組合與我們公司內部的創新業務高度融合,以此結束產品部分。例如,這些產品中的大多數都是與我們的創新品牌使用相同的生產網絡生產的。我們也利用同樣的供應鏈進行分銷。在商業方面,我們不斷探索將生物相似藥與創新產品商業化之間的協同效應,使其成為一種高效的銷售模式,並使我們能夠迅速將經驗應用到我們的產品組合中。

  • We also offer the same provider and patient services as with our innovative portfolio. These advantages are increasingly important as we now face additional biosimilar competition to KANJINTI and MVASI and expect other competitors to enter during 2020.

    我們也提供與我們的創新產品組合相同的供應商和患者服務。隨著 KANJINTI 和 MVASI 面臨更多生物相似藥的競爭,這些優勢變得越來越重要,預計 2020 年將有其他競爭對手進入市場。

  • Our Q4 biosimilar portfolio comprised of KANJINTI and MVASI in the U.S. and AMGEVITA, KANJINTI and MVASI, outside of the U.S. recorded sales of $258 million. In the U.S., KANJINTI and MVASI each recorded $79 million of sales, and we've seen very encouraging adoption rates in the clinic segment, and hospital adoption is accelerating.

    我們第四季的生物相似藥產品組合包括美國的 KANJINTI 和 MVASI 以及美國以外的 AMGEVITA、KANJINTI 和 MVASI,銷售額為 2.58 億美元。在美國,KANJINTI 和 MVASI 的銷售額均為 7,900 萬美元,我們在診所領域的採用率非常令人鼓舞,醫院的採用率也在加速成長。

  • Given the early stage of launch, there is also some inventory stocking during the quarter.

    鑑於產品尚處於上市初期階段,本季也存在一定的庫存積壓。

  • Ex U.S. sales from our biosimilars were $100 million led by AMGEVITA. We continue to see important differences between products and markets in terms of uptake and price erosion, with some markets experiencing strong uptake at more discounted pricing levels while other larger markets, including Germany and France, exhibit a more balanced and sustainable opportunity. Here again, we're able to leverage our expertise and footprint in oncology while AMGEVITA efforts synergize nicely with Otezla.

    除美國以外,我們的生物相似藥銷售額為 1 億美元,其中 AMGEVITA 的銷售額最高。我們繼續看到產品和市場在市場接受度和價格侵蝕方面存在重要差異,一些市場在折扣價水平下獲得了強勁的市場接受度,而其他一些較大的市場,包括德國和法國,則展現出更加平衡和可持續的機會。在這裡,我們再次能夠利用我們在腫瘤學領域的專業知識和影響力,而 AMGEVITA 的努力與 Otezla 也產生了很好的協同效應。

  • In summary, 2019 was a solid year given the evolution of our product portfolio. In 2020, we plan to drive volume uptake of our growth portfolio of products, now including Otezla, while defending our mature brands.

    總而言之,鑑於我們產品組合的發展,2019 年是穩健的一年。2020 年,我們計劃推動我們成長型產品組合(現在包括 Otezla)的銷售成長,同時捍衛我們成熟的品牌。

  • Let me now turn over to Dave Reese.

    現在讓我把麥克風交給戴夫·里斯。

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Thanks, Murdo, and good afternoon, everyone.

    謝謝你,默多,大家下午好。

  • As we enter 2020, we are looking forward to important clinical data from programs across our 3 therapeutic areas: inflammation, oncology and cardiovascular disease. I'll say more about oncology in a moment, but would like to take the opportunity upfront to express our enthusiasm for the BeiGene collaboration. We're off to a good start and look forward to working together to advance the global development of our pipeline of innovative oncology molecules.

    進入 2020 年,我們期待從我們 3 個治療領域(發炎、腫瘤和心血管疾病)的計畫中獲得重要的臨床數據。我稍後會詳細談談腫瘤學,但我想藉此機會提前表達我們對與百濟神州合作的熱情。我們開局良好,期待攜手合作,推動我們創新腫瘤分子產品線的全球開發。

  • I'll now begin my quarterly review in inflammation. We expect Otezla data this year from a Phase III study in over 500 patients with mild-to-moderate psoriasis that have failed topical therapy. This patient population has no approved oral therapy available, and we are confident that Otezla may provide a much needed treatment option. We're working with the CHMP toward a Behçet's indication in Europe and with the FDA on inclusion of the scalp psoriasis data in the U.S. label this year. There are also ongoing studies for new indications, including pediatric psoriasis, and we're evaluating additional studies to expand the opportunity for Otezla.

    接下來我將開始我的季度發炎回顧。我們預計今年將公佈 Otezla 的 III 期研究數據,該研究納入了 500 多名對局部治療無效的輕度至中度乾癬患者。目前尚無核准的口服療法可用於治療這類患者,我們相信 Otezla 或許能為他們提供急需的治療選擇。我們正在與人類藥物委員會 (CHMP) 合作,爭取在歐洲獲得白塞氏症適應症的批准,並正在與美國食品藥物管理局 (FDA) 合作,爭取今年將頭皮乾癬數據納入美國藥品標籤。目前還有針對新適應症(包括兒童銀屑病)的持續研究,我們正在評估其他研究,以擴大 Otezla 的應用機會。

  • I'll also remind you that later this year, we expect Phase III data from our TSLP antibody, tezepelumab, in development with AstraZeneca in severe uncontrolled asthma.

    我還要提醒各位,今年晚些時候,我們將公佈與阿斯特捷利康合作開發的 TSLP 抗體 tezepelumab 在治療嚴重未控制氣喘方面的 III 期臨床試驗數據。

  • In bone health, along with UCB, we were pleased to receive European approval for EVENITY for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. EVENITY is the first new osteoporosis medicine approved in Europe in the last decade, a testament to the need for a new therapy that can rapidly build bone.

    在骨骼健康領域,我們很高興與 UCB 一起獲得歐洲批准,EVENITY 用於治療停經後婦女嚴重骨質疏鬆症,這些婦女有很高的骨折風險。EVENITY 是近十年來歐洲首個獲批的新型骨質疏鬆症藥物,證明了人們需要一種能夠快速促進骨骼生長的新療法。

  • Turning to oncology and hematology. We continue to rapidly advance the development program for AMG510, our first-in-class KRAS G12C inhibitor. We enrolled the potentially pivotal Phase II monotherapy study in advanced non-small cell lung cancer in approximately 3 months and look forward to sharing data later this year when we have at least 6 months' follow-up on all patients.

    轉向腫瘤學和血液學。我們正持續快速推進 AMG510 的研發計劃,AMG510 是我們首創的 KRAS G12C 抑制劑。我們大約在 3 個月內完成了針對晚期非小細胞肺癌的潛在關鍵性 II 期單藥治療研究,並期待在今年稍後分享數據,屆時我們將對所有患者進行至少 6 個月的隨訪。

  • I previously mentioned that we had enrolled a cohort of advanced colorectal cancer patients in our Phase II monotherapy study. Based on the data we have generated to date, we have opened the study to further enrollment and will assess our potential development path in colorectal cancer as additional data become available.

    我之前提到過,我們已經招募了一群晚期大腸直腸癌患者參與我們的 II 期單藥治療研究。根據我們目前獲得的數據,我們已開放研究以進一步招募受試者,並將隨著更多數據的出現評估我們在結直腸癌領域的潛在發展路徑。

  • We also expect to present additional data later this year from our first-in-human monotherapy study in solid tumors, where we will have more information on duration of therapy as well as data in tumor types other than lung and colon cancer.

    我們也預計今年稍後公佈我們在實體瘤中首次進行的人體單藥治療研究的更多數據,屆時我們將獲得更多關於治療持續時間以及除肺癌和結腸癌以外的其他腫瘤類型的數據。

  • We also expect initial data from our Phase I combination study with Keytruda in advanced non-small cell lung cancer. We are enrolling advanced colorectal and non-small cell lung cancer patients in our MEK inhibitor combination study as well as treatment-naive non-small cell lung cancer patients in our ongoing Phase I monotherapy study. We continue to plan additional studies, primarily combination trials, and we'll provide updates as the program progresses.

    我們也期待Keytruda合併治療晚期非小細胞肺癌的I期臨床試驗的初步數據。我們正在招募晚期大腸直腸癌和非小細胞肺癌患者參與 MEK 抑制劑聯合治療研究,同時也招募未經治療的非小細胞肺癌患者參與我們正在進行的 I 期單藥治療研究。我們將繼續計劃進行更多研究,主要是聯合試驗,我們將隨著專案的進展提供最新資訊。

  • We remain enthusiastic about our BiTE platform, and 2020 will be an important year. Based on emerging evidence of anti-tumor activity in both hematologic malignancies and solid tumors, we are growing increasingly confident in the half-life extended format. As we advance our BiTE clinical programs in different tumor settings, we are gaining important insights into dose and schedule and management of adverse events, such as cytokine release syndrome. These insights will guide customized development approaches depending on the target and underlying disease biology.

    我們依然對 BiTE 平台充滿熱情,2020 年將是重要的一年。基於血液惡性腫瘤和實體腫瘤中抗腫瘤活性的新證據,我們對半衰期延長型製劑越來越有信心。隨著我們在不同的腫瘤環境中推進 BiTE 臨床項目,我們對劑量、給藥方案以及不良事件(如細胞激素釋放綜合徵)的管理有了重要的了解。這些見解將指導根據目標和潛在疾病生物學採取客製化的開發方法。

  • Over the course of the year, we anticipate sharing data from some of these programs and I'll provide further guidance on expected data presentations as these molecules advance. We're now pursuing 2 half-life extended BiTE programs for gastric cancer and recently initiated a first-in-human study for AMG 199, which is directed against MUC17, a target widely expressed in gastric cancer. Gastric cancer, as you know, is highly prevalent in East Asia, where we have a growing presence through our impending Japan subsidiary and collaboration with BeiGene. As I previously discussed, we intend to present the data for AMG 701, our half-life extended BCMA BiTE, when we have a meaningful data set, most likely in the second half of this year.

    在接下來的一年中,我們預計將分享其中一些項目的數據,隨著這些分子的進展,我將對預期的數據展示提供進一步的指導。我們目前正在進行 2 個延長半衰期的 BiTE 治療胃癌的項目,並且最近啟動了 AMG 199 的首次人體研究,該藥物針對的是 MUC17,MUC17 是胃癌中廣泛表達的標靶。如您所知,胃癌在東亞地區非常普遍,而我們正透過即將成立的日本子公司以及與百濟神州的合作,在東亞地區不斷擴大業務。正如我之前討論過的,我們打算在獲得有意義的數據集後,公佈我們的半衰期延長型 BCMA BiTE AMG 701 的數據,這很可能在今年下半年。

  • We've also made several regulatory submissions in oncology, including the KYPROLIS CANDOR study in the U.S., the KYPROLIS plus dexamethasone in China for relapsed and refractory multiple myeloma, and BLINCYTO in China for relapsed/refractory ALL. We look forward to working with BeiGene to advance these important medicines.

    我們也在腫瘤領域提交了多項監管申請,包括美國的 KYPROLIS CANDOR 研究、中國的 KYPROLIS 加地塞米松治療復發/難治性多發性骨髓瘤,以及中國的 BLINCYTO 治療復發/難治性 ALL。我們期待與百濟神州合作,共同推動這些重要藥物的研發。

  • In cardiovascular disease, along with Cytokinetics, we look forward to the data from the omecamtiv mecarbil Phase III outcome study in the fourth quarter of this year. Our heart failure treatment landscape is expected to change based on recent data from other drug classes. We believe significant residual unmet medical need remains in this global epidemic. Also in cardiovascular disease, our Lp(a) siRNA, AMG 890, continues to advance, and we expect to initiate Phase II development in the first half of the year.

    在心血管疾病領域,我們和 Cytokinetics 一起期待今年第四季 omecamtiv mecarbil III 期結果研究的數據。根據其他藥物類別的最新數據,我們預期心臟衰竭的治療模式將會改變。我們認為,在這場全球疫情中,仍有大量尚未滿足的醫療需求。在心血管疾病領域,我們的 Lp(a) siRNA AMG 890 也持續取得進展,我們預計今年上半年啟動 II 期開發。

  • Finally, on biosimilars, we're pleased to receive U.S. approval for AVSOLA, our biosimilar Remicade, and to make our U.S. regulatory submission for ABP 798, our biosimilar Rituxan. I'm also pleased to announce that we are initiating a Phase III study with our seventh biosimilar, ABP 938, our biosimilar aflibercept or EYLEA. Bob?

    最後,關於生物相似藥,我們很高興獲得美國對 AVSOLA(我們的 Remicade 生物相似藥)的批准,並向美國監管機構提交了 ABP 798(我們的 Rituxan 生物相似藥)的上市申請。我也很高興地宣布,我們將啟動第七款生物相似藥 ABP 938(阿柏西普生物類似藥或 EYLEA)的 III 期研究。鮑伯?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Thanks, Dave. Ian, why don't we open the lines up for questions now and please remind our callers of the process.

    好的。謝謝你,戴夫。伊恩,我們現在就開通提問專線吧,也請你提醒來電者們流程。

  • Operator

    Operator

  • (Operator Instructions) Our first question is from the line of Jay Olson from Oppenheimer & Company.

    (操作說明)我們的第一個問題來自奧本海默公司的傑伊·奧爾森。

  • Jay Olson - Executive Director & Senior Analyst

    Jay Olson - Executive Director & Senior Analyst

  • Congrats on the quarter. You talked a little bit about net pricing dynamics for Aimovig. Could you maybe elaborate a little bit on how you expect the competitive dynamic to shape up in the CGRP space? And any long-term data you could potentially leverage there?

    恭喜你本季取得佳績。您剛才談到了Aimovig的淨定價動態。您能否詳細闡述您預期C​​GRP領域的競爭格局將如何改變?是否有任何可以利用的長期數據?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks for the question, Jay. It's Murdo here. We're very pleased with Aimovig's market access position now with over 92% of covered lives having access to Aimovig at a very affordable co-pay. We're also pleased with the addition this year of CVS. Last year, we did not have CVS as a benefit to -- as a -- with Aimovig as a benefit, and we do as of the beginning of this year, and we've already seen an acceleration in our new patient uptake. We are happy that the percentage of patients that are receiving paid prescriptions now of Aimovig is above 80%. And that bodes well for the future growth of this category because we've got highly effective medicines that have an impact, a significant impact on the reduction of migraine days on migraine sufferers. And we have a lot of them. There's 4 million eligible patients out there in the U.S., and they're able to access Aimovig at a very affordable co-pay. So that's good for the future outlook of the category. Obviously, because we did contract to secure that additional access, there will be a reduction in our net selling price that you'll see in Q1, and then we expect it to be relatively stable over time. Now because this is a retail benefit product, you do see some fluctuations as you make true-ups in the mix of your product that comes through Medicaid, commercial or, to some extent, Medicare Part D. But overall, we would expect, post Q1, stability in net selling price.

    謝謝你的提問,傑伊。我是默多。我們對 Aimovig 目前的市場准入狀況非常滿意,超過 92% 的受保人可以以非常實惠的共同支付費用獲得 Aimovig 服務。我們也很高興今年CVS的加入。去年,我們沒有將 CVS 作為一項福利——作為一項福利——將 Aimovig 作為一項福利,而從今年年初開始,我們有了這項福利,我們已經看到新患者的接受度有所提高。我們很高興看到,目前獲得 Aimovig 付費處方的患者比例超過 80%。這對這一類別的未來成長來說是個好兆頭,因為我們擁有高效的藥物,可以顯著減少偏頭痛患者的偏頭痛天數。我們有很多這樣的房子。美國有 400 萬名符合條件的患者,他們可以以非常實惠的自付費用獲得 Aimovig 治療。所以這對該品類的未來前景來說是件好事。顯然,由於我們簽訂了合約以確保獲得額外的供應管道,因此您將在第一季看到我們的淨售價下降,之後我們預計價格會隨著時間的推移而相對穩定。由於這是一款零售福利產品,因此在調整透過醫療補助、商業保險或部分聯邦醫療保險D部分管道銷售的產品組合時,價格會出現一些波動。但總體而言,我們預計第一季後淨售價將保持穩定。

  • Operator

    Operator

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

    下一個問題是來自傑富瑞集團的邁克爾葉的演講。

  • Michael Jonathan Yee - Equity Analyst

    Michael Jonathan Yee - Equity Analyst

  • I had an R&D question for David. Of course, there's a lot of attention on AMG 510. You made a lot of great comments about how you quickly enrolled the study, and we're going to get data later this year. One of the things I picked up on was your comments about first-line lung. Can you just maybe make a comment about how that advances or how that progresses? Or how you go about a first-line strategy, that's obviously a huge opportunity. So maybe just comment about where that monotherapy study goes and where you can go with first line.

    我有一個研發方面的問題想問David。當然,AMG 510 受到了很多關注。您就如何迅速招募參與者發表了許多精彩的評論,我們將在今年稍後獲得數據。我注意到的一點是你對一線肺的評論。您能否就此事的進展或發展發表一下看法?或者說,如何制定一線策略,這顯然是一個巨大的機會。所以,或許可以評論一下單藥治療研究的進展情況,以及第一線治療方案的選擇方向。

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes. Thanks, Michael. That is intended to provide a potential treatment option for patients who are not eligible for other first-line lung therapies or unwilling to take such therapies. I think it will provide incredibly valuable clinical information on response to the drug in a previously untreated population. We've just started enrolling that in the -- so -- over the course of the year. As we generate data, we'll provide guidance as to when we may have some things to share.

    是的。謝謝你,麥可。其目的是為不符合其他第一線肺部治療條件或不願接受此類治療的患者提供潛在的治療選擇。我認為這將為先前未接受過藥物治療的人群提供關於藥物反應的極其寶貴的臨床資訊。我們剛開始將這個項目納入其中——所以——將持續一年。隨著我們產生數據的不斷積累,我們將提供指導,說明何時可以分享一些資訊。

  • Operator

    Operator

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

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

  • Christopher Joseph Raymond - MD & Senior Research Analyst

    Christopher Joseph Raymond - MD & Senior Research Analyst

  • Just on M&A priorities. So Bob, I was kind of struck a couple of weeks ago in San Francisco. You guys talked about renal as maybe an area of interest in terms of building out the pipeline. And you're offering, obviously, augmenting what is a pretty formidable business now. But I think the wording that I heard you say, Bob, was that any asset you bring in would have to be game changing. So maybe 2 parts. Can you talk about the reasoning for this sort of focus on renal or at least articulating that to us? And then what are you really looking for in terms of a game-changing therapy?

    僅就併購優先事項而言。鮑勃,幾週前我在舊金山遇到了一些麻煩。你們之前提到過,腎臟領域可能是拓展產品線的一個興趣領域。顯然,你提供的服務是在增強目前已經相當強大的業務。但我認為我聽到的你的措辭是,鮑勃,你引進的任何資產都必須是能夠改變遊戲規則的。所以可能是兩個部分。您能否談談為何要如此關注腎臟疾病,或至少向我們解釋原因?那麼,你真正想要的是一種能夠改變人生的療法嗎?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Yes. So Chris, just to remind you, we have 6 commercial franchise areas, of which nephrology is one. Obviously, that was our first, and we've been a leader in that area now for several decades. We have a number of important products for nephrologists today. And we intend to continue to serve the needs of patients and physicians and providers, et cetera in that community. We have not found in our own discovery research efforts that we've been able to find the kinds of game-changing innovation that we want to invest in from a discovery standpoint. So we're not investing in discovery, research and nephrology right now. But we are going to look for business development opportunities there. And in general, our strategy when it comes to business development is to look for medicines that make a big difference for patients suffering from these diseases. So we'll look for innovation and large effect size. I don't know that I used the word game changer, but if I did, that's what I was intending to reflect, the notion of large effect size, innovative medicines. So to the extent there are some in the industry or otherwise medicines where, again, we think because of the historical investment we've had with this community of patients that we can add real value, we'll look.

    是的。所以克里斯,提醒你一下,我們有 6 個商業特許經營領域,腎臟病學是其中之一。顯然,那是我們的第一個項目,而且幾十年來我們一直是該領域的領導者。我們目前為腎臟科醫生提供多種重要產品。我們將繼續為該社區的患者、醫生、醫療服務提供者等提供服務。我們自身的探索性研究工作尚未發現我們想要從探索角度投資的那種具有顛覆性意義的創新。所以,我們目前沒有在發現、研究和腎臟病學方面進行投資。但我們將在那裡尋找業務發展機會。總的來說,我們在業務拓展方面的策略是尋找能夠為患有這些疾病的患者帶來巨大改變的藥物。所以我們會尋找創新和較大的影響規模。我不知道我是否用了「改變遊戲規則」這個詞,但如果我用了,那就是我想表達的意思,即具有巨大療效的創新藥物。因此,如果業內或其他領域有一些藥物,我們認為由於我們與這個患者群體的歷史性投入,我們可以為其增添真正的價值,我們就會去尋找。

  • Operator

    Operator

  • And our next question line of Brian Skorney from Robert W. Baird & Company.

    接下來,我們連線到羅伯特·W·貝爾德公司的布萊恩·斯科尼。

  • Brian Peter Skorney - Senior Research Analyst

    Brian Peter Skorney - Senior Research Analyst

  • One quick one -- actually, 2 quick ones on housekeeping. Just -- it looks like compared to last quarter, you saw a 6% decline in Neulasta market share. Can you just break out how much of that was Onpro loss? And can you also talk about how Onpro price has been impacted by the biosimilars have been able to maintain price so far? Or have you taken greater discounts to maintain that share?

    一個簡短的問題——實際上是兩個關於家務的簡短問題。看起來與上個季度相比,Neulasta 的市佔率下降了 6%。你能具體說明一下其中有多少是Onpro造成的損失嗎?您能否也談談生物相似藥對Onpro價格的影響,以及它們目前是如何維持價格的?或者,您為了維持市場佔有率而接受了更大的折扣?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Those are good questions for Murdo. Why don't you go ahead, Murdo?

    好的。這些都是問默多的好問題。為什麼不先走呢,默多?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Brian. The majority of the share decline is from the prefilled syringe. Onpro exited at a 55% share of long-acting filgrastim and continues to hold up well in terms of share. We have had a contract out there that provides some discount to Onpro, but it's a more modest discount than you would see on the prefilled syringe.

    是的。謝謝你,布萊恩。市佔率下降的主要原因是預充式註射器業務的下滑。Onpro 退出時佔據了長效非格司亭 55% 的市場份額,並且在市場份額方面仍然保持良好水平。我們與 Onpro 簽訂了一份合同,可以提供一些折扣,但折扣力度比預填充注射器小得多。

  • Operator

    Operator

  • 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。

  • Evan David Seigerman - VP & Senior Equity Research Analyst

    Evan David Seigerman - VP & Senior Equity Research Analyst

  • One on biosimilars. So what are some gating factors to achieve? I think it's multibillion? Or are you at 1% greater than $3 billion in sales across the franchise? And if there were to be implementation of an international pricing index or most favored nation clause for Medicare Part B, how would this potentially impact your biosimilars business?

    一篇關於生物相似藥的文章。那麼,需要達到哪些門檻條件呢?我認為是數十億美元?或者,你們整個特許經營店的銷售額是否比 30 億美元高出 1%?如果醫療保險 B 部分實施國際定價指數或最惠國條款,這將對您的生物相似藥業務產生怎樣的潛在影響?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • I can take a stab at the first part of your question and Murdo, I invite you to jump in. But since we made those undertakings before you were part of the team, Murdo, the notion that we articulated was that we were going to advance a portfolio of up to 10 biosimilars that we expected that these could be an attractive growth opportunity for the company. And we're off to a good start. As you heard me say earlier, at the end of the fourth quarter, we were annualizing in excess of $1 billion. So we're off to a good start. We're on time, we're on budget with these programs. And the gating item is simply product approvals and product launches. So we remain enthusiastic about our chance to earn a return from these products. And as to the specifics of IPI, we don't just say, in general. We obviously would be concerned, we think quite a few other stakeholder groups would as well about the disruption that IPI would represent to the innovative biopharmaceutical industry. And we think there are better ways to evolve our system in a way that ensures patients have access to medicines at affordable prices. But Murdo, feel free if you want to add anything specific about IPI and biosimilar landscape.

    我可以嘗試回答你問題的第一部分,Murdo,請你也來發表一下意見。但是,默多,由於這些承諾是在你加入團隊之前做出的,我們當時提出的想法是,我們將推進多達 10 種生物相似藥的產品組合,我們預計這些產品組合將為公司帶來有吸引力的成長機會。我們開局不錯。正如我之前所說,在第四季末,我們的年化收入超過了 10 億美元。我們開局不錯。這些項目我們都能準時在預算內完成。而關鍵環節就是產品審批和產品發布。因此,我們仍然對從這些產品中獲得回報的機會充滿熱情。至於 IPI 的具體細節,我們不會只是泛泛而談。我們當然會感到擔憂,我們認為其他一些利害關係人也會如此,因為IPI可能會對創新生物製藥產業造成衝擊。我們認為,還有更好的方法來改進我們的系統,以確保患者能夠以可負擔的價格獲得藥品。不過,Murdo,如果你想補充一些關於IPI和生物類似藥領域的具體信息,請隨意。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Nothing on IPI, Bob. I think you summarized it well. And on biosimilars, the only thing I would say is I'm thankful to have inherited this portfolio and for the decisions that were made prior to my arrival. I think this is a strong business opportunity. It's been one we've been able to realize very good competitive share in Europe. And we're off to a very good start in our early launch in the U.S., and I look forward to being able to launch more products.

    鮑勃,IPI上沒有任何消息。我覺得你總結得很好。至於生物相似藥,我只想說,我很感激能夠接手這個產品組合,也很感謝在我到來之前做出的各項決定。我認為這是一個絕佳的商機。我們在歐洲已經取得了非常好的市場份額。我們在美國早期推廣取得了非常好的開端,我期待著能夠推出更多產品。

  • Operator

    Operator

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

    下一個問題是來自加拿大皇家銀行資本市場的 Kennen MacKay 的演講。

  • Kennen B. MacKay - MD & Co-Head of US Biotechnology Research

    Kennen B. MacKay - MD & Co-Head of US Biotechnology Research

  • Congrats on the end of the year in 2019. I totally agree, it was transformative. Maybe for Murdo, I was wondering if you could talk a little bit about the synergies you're seeing or expecting between selling of both Otezla and Enbrel, and whether there were any tailwinds there to year-end formulary rebating or contracting negotiations we should think about pricing or access in the year ahead.

    祝賀2019年圓滿結束。我完全同意,這確實改變了我的人生。或許對 Murdo 來說,我想請您談談您在 Otezla 和 Enbrel 的銷售方面看到或預期到的協同效應,以及這是否會對年底的處方集回扣或合約談判產生任何有利影響,我們應該考慮未來一年的定價或准入問題。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks for the question, Kennen. Yes, we're excited about potential synergies between Otezla and Enbrel, and quite frankly, by extension, our biosimilars business coming into the inflammation category. Too early to comment on specifics, but we continue to work through our contracting strategy, promotional strategy, even things as simple as possibly expanding into primary care promotion because we have a fairly large primary care footprint. And then clearly, our international geographic expansion is augmented by having Otezla joining our portfolio with potential new markets, where perhaps Otezla was slated to be launched by distributors when we have a full-blown affiliate in some of those markets. And then the last piece is, of course, synergies as we go into some of the new indication areas. So I'm excited about building those out. Our teams are working hard to realize those synergies. And I feel optimistic that we'll be able to be more specific in upcoming quarters.

    謝謝你的提問,肯南。是的,我們對 Otezla 和 Enbrel 之間潛在的協同效應感到興奮,坦白說,我們也對我們的生物相似藥業務進入發炎領域感到興奮。現在評論具體細節還為時過早,但我們仍在不斷完善我們的合約策略、推廣策略,甚至像擴大到基層醫療推廣這樣簡單的事情也在考慮之中,因為我們在基層醫療領域擁有相當大的影響力。顯然,隨著 Otezla 加入我們的產品組合,我們的國際地域擴張得到了加強,並帶來了潛在的新市場。或許,當我們在某些​​市場擁有成熟的附屬公司時,Otezla 原本計劃由經銷商推出。最後一點當然是,當我們進入一些新的適應症領域時,就會產生綜效。所以我很期待能把這些項目都完成。我們的團隊正在努力實現這些協同效應。我樂觀地認為,在接下來的幾個季度裡,我們將能夠給出更具體的數據。

  • Operator

    Operator

  • 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。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I am just extraordinarily confused today on the guidance, but I'll limit my question to 2 specific things, perhaps. First, Peter, on the OI&E line, if you can bear with me for a second, you mentioned $1.2 billion to $1.4 billion. And I was trying to think it through, and I thought to myself, $30 billion debt at just above 3% rate. So that's $1 billion in interest expense, minus about $100 million of the interest income, so that's $900 million. So when you guide to $1.2 billion to $1.4 billion, that's effectively implying $300 million to $500 million for BeiGene. But my understanding was you're only booking 20%. And I'm just trying to understand, is BeiGene's implied net income $1.5 billion to $2.5 billion? Or am I thinking about that wrong? Because that sounds so much higher than what BeiGene does. That's number one.

    我今天對相關指導感到非常困惑,但我可能只會問兩個具體的問題。首先,Peter,關於OI&E線路,如果你能稍等片刻,你提到了12億到14億美元。我當時努力思考這個問題,然後我想,300億美元的債務,利率略高於3%。所以利息支出為 10 億美元,減去約 1 億美元的利息收入,就是 9 億美元。所以,當你預測百濟神州的營收將達到 12 億至 14 億美元時,實際上就意味著百濟神州的營收將達到 3 億至 5 億美元。但我理解的是,你們只預訂了 20%。我只是想了解一下,百濟神的隱含淨收入是在 15 億美元到 25 億美元之間嗎?還是我的想法錯了?因為那聽起來比百濟神的業績高得多。這是第一點。

  • And secondly, on revenues, I noticed -- I know the business is being implied flat year-over-year outside of Otezla. So I just wanted to understand better what the pushes and the pulls are there? And perhaps, also, I think you'd mentioned biosimilars doing $1 billion in 2020. Annual 4Q '19 alone was north of $1 billion run rate. So just trying to understand all this.

    其次,關於收入,我注意到——我知道除了 Otezla 之外,業務似乎與去年同期持平。所以我想更了解其中的推動因素和拉動因素是什麼?而且,我想您也提到過生物相似藥在 2020 年的銷售額達到了 10 億美元。光是 2019 年第四季度,全年營收就超過了 10 億美元。我只是想弄清楚這一切。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Umer, let's try to go through that. I think there were 3 questions there. So Murdo, you want to take the first 2 on the revenue? Just clarify what we said. And then, Pete, you can help clarify the OI&E, other interest and expense line item.

    好的。烏默,我們來仔細看看。我認為那裡有3個問題。所以默多,你想拿前兩名的收入嗎?請你澄清一下我們剛才說的話。然後,皮特,你可以幫忙解釋一下 OI&E,即其他利息和費用項目。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Sure. So yes, we've guided that our base business will be stable year-over-year. Obviously, there are a range of outcomes on that portfolio, and we continue to work hard across a number of opportunities to do as we've done historically, and that is to outperform. I would say that Otezla has come in, and we have seen very good, seamless integration of that team and that performance of that product and the growth trajectory continues without any interruption through the fourth quarter, and we're seeing strong weeks early in the new year. On biosimilars, it's very early in the launch of those 2 products where we are annualizing, as you pointed out, at over $1 billion based on fourth quarter, and we expect to be able to continue to accelerate that business.

    當然。是的,我們預期我們的基礎業務將保持逐年穩定。顯然,該投資組合存在多種結果,我們將繼續努力抓住各種機會,並像以往一樣取得優異成績。我認為 Otezla 的加入非常出色,我們看到了團隊的無縫整合,該產品的表現和成長軌跡在第四季度持續保持良好勢頭,並且在新年伊始的幾周里也表現強勁。關於生物相似藥,目前這兩款產品還處於上市初期,正如您所指出的,根據第四季度的數據,我們的年銷售額已超過 10 億美元,我們預計能夠繼續加速這項業務的發展。

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Umer, Peter here. Thanks for your question. I would take you to the fact that our total debt at the interest rate I talked about in my remarks at 3.7% average maturity, 12 years, by the way. I mentioned that, too. That, plus the 20.5% of BeiGene's results for 2020, the publicly available consensus estimates are what we're guiding to. So when you work through those two, you should get pretty close to our $1.2 billion to $1.4 billion for 2020.

    我是彼得,烏默。謝謝你的提問。我想指出的是,以我剛才提到的利率 3.7% 計算,我們的總債務平均期限為 12 年。我也提到過這一點。再加上百濟神州 2020 年業績的 20.5%,以及公開的共識估計值,這就是我們給出的指導意見。所以,當你把這兩個因素考慮進去之後,你應該就能非常接近我們 2020 年的 12 億至 14 億美元目標了。

  • Operator

    Operator

  • And our next question is from line of Robyn Karnauskas from SunTrust Robinson Humphrey.

    下一個問題來自 SunTrust Robinson Humphrey 的 Robyn Karnauskas。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • I don't want to beat a dead horse, but I guess, I'm confused, too, just by this lack of growth given that your slides here have outlined in your last -- you've lost like half Onpro's holding. You're growing like a bunch of different products. So what is the 1 thing you think that is going to prevent you from growing more this year? Not just having a stable business year-over-year. That's sort of what I'm struggling with the most. Just help me understand that because the way you described it, it looks like more growth of the top line.

    我不想老生常談,但我也感到困惑,因為你在幻燈片中概述了上次的情況,而現在卻沒有增長——你已經失去了 Onpro 大約一半的股份。你的成長方式就像很多不同的產品。那麼,你認為今年阻礙你有更大進步的1件事是什麼?不僅僅是業務逐年保持穩定。這正是我目前最困擾的地方。請幫我理解一下,因為按照你的描述,這看起來像是營收成長更多了。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Sorry, Robyn, repeat the last piece of your question? What do we (inaudible)?

    抱歉,Robyn,請你再說一次你問題的最後一部分?我們該怎麼辦(聽不清楚)?

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • Sure. Just like, the way you're describing your businesses in your slide performance basically is that you're growing many parts of the business, and the part that is declining as a loss seems to be potentially stabilizing with Onpro. So what is preventing you from growing beyond what you're guiding? Is there one particular thing? I think, most of us are sitting there saying, why can't you grow more than what you've outlined, given the picture that you painted of the business being actually quite strong?

    當然。就像你在幻燈片簡報中描述你的業務一樣,基本上就是你的業務很多部分都在成長,而虧損的部分似乎隨著 Onpro 的推出而趨於穩定。那麼,是什麼阻礙了你超越你目前所引導的範圍呢?有什麼特別之處嗎?我想,我們大多數人都會想,既然你描述的公司發展勢頭非常強勁,為什麼你不能發展得比你概述的還要好呢?

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • So I'd agree with your last comment. The picture of the business does look quite strong. We're pleased with what we've been able to achieve, particularly in the back half of last year.

    所以我同意你最後那則評論。這家公司的經營狀況看起來相當不錯。我們對自己所取得的成就感到滿意,尤其是在去年下半年。

  • As I mentioned earlier, some of the Neulasta stability with Onpro has been at the expense of contracted terms, which lower the net price of that total portfolio, inclusive of Onpro. And we would expect, with additional competitors against Neulasta in the biosimilar space, that there will be further net price erosion in the long-acting filgrastim category. And of course, overall, in our total portfolio worldwide, we would expect single-digit net price declines for the year. Now that goes up against what I talked about throughout the call is we have a number of really strong growth drivers in a young portfolio of very diverse products, and we have guided a wide range on revenue. And it's my hope that the strong execution we saw in the back half of last year continues into this year, and we can achieve a good growth profile, not just in Otezla, but in the base business.

    正如我之前提到的,Neulasta 與 Onpro 之間的一些穩定性是以犧牲合約條款為代價的,這降低了包括 Onpro 在內的整個投資組合的淨價。我們預計,隨著生物相似藥領域出現更多與 Neulasta 競爭的藥物,長效非格司亭類藥物的淨價格將進一步下降。當然,總體而言,在我們全球的整體投資組合中,我們預計今年的淨價格降幅將為個位數。這與我在整個電話會議中所說的相悖,我們擁有許多非常強勁的成長動力,這些動力來自我們年輕的、產品種類繁多的產品組合,而且我們對收入的預期範圍也很廣。我希望去年下半年的強勁執行力能夠延續到今年,我們不僅能在 Otezla 實現良好的成長,而且在基礎業務方面也能取得良好的成長。

  • Operator

    Operator

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

    下一個問題是高盛的 Terence Flynn 的發言。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • Omecamtiv is a product you guys haven't talked a lot about recently. Obviously, some Phase III data coming later this year. Dave, you mentioned it in your remarks as well in terms of kind of the change in treatment landscape. But just curious if you could remind us of the puts and takes for the program as we think about the probability of success here? And what would really get you guys excited to that type of data?

    Omecamtiv是你們最近很少提及的產品。顯然,一些三期臨床試驗數據將於今年稍後公佈。戴夫,你在發言中也提到了治療格局的改變。不過,我們想問一下,您能否提醒我們這個專案的投入產出情況,以便我們評估其成功機率?那麼,什麼樣的數據才能真正激發你們對這類數據的興趣呢?

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes. Sure, Terence. This is Dave. I'm happy to address that. I mean as I mentioned in my remarks, heart failure is a global epidemic. What makes us continue to have excitement in omecamtiv, it's a first-in-class mechanism of action. It's the only drug ever introduced that actually acts directly on the heart cell to improve contractility or the heart's pumping function. And we're conducting what'll be a definitive 8,200-patient, give or take, trial in patients with advanced heart failure. It's a fairly sick population where we're going to be looking for mortality benefit and a variety of other clinical outcome measures that improved. So I think there's a large amount of residual unmet medical need. And obviously, where this fits in a changing treatment landscape will depend on the profile that emerges from that Phase III trial.

    是的。當然可以,特倫斯。這是戴夫。我很樂意回答這個問題。正如我剛才所說,心臟衰竭是一種全球性流行病。是什麼讓我們對omecamtiv持續感到興奮呢?是因為它具有首創的作用機轉。這是目前唯一能夠直接作用於心肌細胞,改善心肌收縮力或心臟泵血功能的藥物。我們正在進行一項最終的試驗,預計將有大約 8200 名晚期心臟衰竭患者參與。這是一個健康狀況相當糟糕的群體,我們將尋找降低死亡率和其他各種臨床結果指標的改善。所以我認為仍然存在大量未被滿足的醫療需求。顯然,這種療法在不斷變化的治療模式中處於什麼位置,將取決於 III 期試驗的結果。

  • Operator

    Operator

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

    下一個問題來自伯恩斯坦研究公司的 Ronny Gal。

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • Congratulations on the nice 2019 and got 1 housekeeping and 1 question. The quick one is, I was wondering if you could give us your comment on the Medicaid block grant that just was announced today. Does that have any relevance to you? And then generally, where do you expect it will impact the drug industry? And second, David, I was wondering if you can give me your view on the Memorial Sloan Kettering paper suggesting that targeting the active GTP-bound form of KRAS is better than trapping the GDP KRAS in the inactive form in terms of preventing tumors -- tumor resistance to those agents.

    恭喜你度過了美好的2019年,並收到了1條家事服務和1個問題。簡單來說,我想問您能否對今天剛宣布的醫療補助金撥款發表一下看法。這跟你有什麼關係嗎?那麼,總體而言,您認為它將對製藥業產生哪些影響?其次,David,我想請你談談紀念斯隆-凱特琳癌症中心的那篇論文,該論文指出,就預防腫瘤(腫瘤對這些藥物的抗藥性)而言,靶向活性 GTP 結合形式的 KRAS 比將 GDP KRAS 捕獲在非活性形式中更好。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Good. Well, let me -- I'll knock off the Medicaid piece first, Ronny. It's -- for those who are on the call who aren't aware, CMS released some guidance earlier today, so we and others are still chewing through it. I think it will have very limited impact at first read of it for us. But it's likely to be relevant for those states that didn't opt into ACA in the first instance. And we'll go through it as well, I'm sure others in our industry, more closely to see whether there are any specific issues for our business. But it didn't seem to me, Ronny, that, that was going to be a concern for us in 2020. Dave, you want to tackle the Sloan (inaudible)

    好的。好吧,讓我先解決醫療補助那部分,羅尼。——對於那些正在參加電話會議但還不了解情況的人來說,CMS今天早些時候發布了一些指導意見,所以我們和其他人仍在仔細研究這些意見。我認為它對我們初讀的影響非常有限。但這可能與那些最初沒有選擇加入《平價醫療法案》的州有關。我相信我們行業內的其他公司也會更仔細地研究這個問題,看看是否有任何與我們業務相關的具體問題。但在我看來,羅尼,這在 2020 年應該不會成為我們擔心的問題。戴夫,你想攻下克斯隆(聽不清楚)

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes. I'm sure you don't want to address that one, Bob. So for those who aren't familiar, Ronny is referring to a paper that came out within the last month or so that suggests that also targeting the GDP-bound form of KRAS G12C would be required for signaling inhibition. We read the paper with interest, of course, make a couple of observations. First, I would say our own data with AMG 510 suggests that at the appropriate doses and doses that we can achieve clinically, we can completely suppress signaling throughout a dosing interval. It is also my understanding or belief that the G12C inhibitor used in that paper may have been a little less potent. And one thing that we've learned over 40 years in oncology is that if you incompletely inhibit a target, you very quickly breed resistance. So I would say, I feel very confident based on the preclinical data that we've generated with AMG 510. We're, of course, profiling tumors across our clinical program to try to generate signatures of response and resistance. This is the sort of thing that we'll look at, but I don't see anything in the literature as of yet that dissuades me from the approach we're currently taking.

    是的。鮑勃,我肯定你不想談這件事。所以對於那些不熟悉的人來說,Ronny 指的是最近一個月左右發表的一篇論文,該論文表明,抑制信號傳導還需要針對 KRAS G12C 的 GDP 結合形式。我們饒有興趣地閱讀了這篇論文,當然,也提出了幾點看法。首先,我想說,我們自己使用 AMG 510 的數據表明,在適當的劑量和我們臨床上能夠達到的劑量下,我們可以在整個給藥間隔內完全抑制信號傳導。據我了解或認為,該論文中使用的 G12C 抑制劑的效力可能稍弱一些。我們在腫瘤學領域 40 多年的經驗告訴我們,如果對標靶的抑制不完全,很快就會產生抗藥性。所以,根據我們利用 AMG 510 所獲得的臨床前數據,我感到非常有信心。當然,我們正在臨床項目中對腫瘤進行分析,以期找到反應和抗藥性的特徵。這是我們將會研究的問題,但就目前而言,我還沒有在文獻中看到任何可以動搖我們目前所採取方法的內容。

  • Operator

    Operator

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

    下一個問題來自花旗銀行的 Mohit Bansal。

  • Mohit Bansal - VP and Analyst

    Mohit Bansal - VP and Analyst

  • A quick question on Otezla in mild to moderate psoriasis. It seems like you'll have data later this year. But given that the rate is kind of a standard of care in that particular market and is a generic, what sort of challenge do you anticipate placing Otezla in that market? And how do you think about navigating those challenges there?

    關於 Otezla 治療輕度至中度乾癬的問題,請問一下?看來你們要到今年晚些時候才能拿到數據。但鑑於該價格在該特定市場中屬於標準價格,而且是通用價格,您預計 Otezla 在該市場中會面臨什麼樣的挑戰?那麼,您打算如何應對那裡的這些挑戰呢?

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes. Well, let me start, Mohit, and then I'll ask Murdo to jump in. So in mild to moderate psoriasis, there are currently no approved oral therapies. The only thing really available to patients right now is topical therapy. Many of them will not ultimately experience disease control with those topical therapies. And so we think there's a real opportunity for Otezla in that area. They are up to nearly 6 million patients with mild to moderate psoriasis in the United States alone, so that gives you a sense of the size of this opportunity and actually the prevalence of the disease. Murdo?

    是的。好,莫希特,我先開始,然後我再請默多加入。因此,對於輕度至中度乾癬,目前尚無核准的口服療法。目前患者唯一可用的治療方法是局部用藥。最終,許多患者無法透過這些局部療法控制病情。因此,我們認為 Otezla 在該領域擁有真正的機會。光是在美國,就有近 600 萬名患有輕度至中度乾癬的患者,這讓你對這個機會的規模以及疾病的普遍程度有了一定的了解。默多?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. And Mohit, the only thing I would add is, yes, there's some methotrexate use there, but it's largely a topical business, as Dave described. And it's largely a patient population that gives very little relief. And this is really a patient population that is in the sweet spot for Otezla. The other thing I have to say is that our new colleagues when building out their positioning strategy for Otezla and their payer strategy, have done a very, very nice job, both positioning the access and reimbursement for Otezla as a post topical prebiologic option. So I think for the mild to moderate population, if we're successful in securing that indication, that same payer strategy will be continued. So I feel confident that we're in good shape there for another source of growth for Otezla going forward.

    是的。莫希特,我唯一要補充的是,是的,那裡確實有一些甲氨蝶呤的使用,但正如戴夫所描述的那樣,它主要是一種外用療法。而且,這主要是一群療效甚微的患者群。而這正是 Otezla 最適用的患者族群。我還要說的是,我們的新同事在製定 Otezla 的定位策略和支付方策略時,做得非常出色,將 Otezla 的獲取和報銷定位為局部用藥後的前生物製劑選擇。所以我認為,對於輕度至中度患者群體,如果我們成功獲得該適應症,同樣的支付方策略將會繼續實施。因此,我相信我們已經做好了充分的準備,這將為 Otezla 的未來發展提供另一個成長點。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • So Ian, I know we've got several calls -- or several questions still queued up. So we'll try to get through those. Apologies that we're beyond the top of the hour here, but let's go on to the next question.

    伊恩,我知道我們還有好幾通電話——或者說好幾個問題——等著我們去處理。所以我們會努力克服這些困難。很抱歉現在已經過了整點,我們繼續下一個問題。

  • Operator

    Operator

  • Certainly. Our next question is from the line of Matthew Harrison from Morgan Stanley.

    當然。我們的下一個問題來自摩根士丹利的馬修·哈里森。

  • Matthew Kelsey Harrison - Executive Director

    Matthew Kelsey Harrison - Executive Director

  • I just wanted to follow-up on a comment that Dave made earlier in the call, suggesting, I think, that maybe you're seeing some activity in HLE BiTEs in both solid tumors and liquid tumors. Maybe you could just characterize for us what data you have internally that gave you the confidence to make that statement?

    我只是想跟進一下 Dave 在電話會議早些時候提出的一個評論,我認為,這表明 HLE BiTEs 在實體瘤和血液腫瘤中可能都表現出一些活性。您能否向我們說明一下,您內部有哪些數據讓您有信心做出這樣的聲明?

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes. Thanks, Matt. And I assume that someone would pick up on that statement. So what I would say is I'm not ready to declare victory in any indication yet. But we're seeing the sort of pharmacodynamic activity and early suggestions of antitumor activity that are reminiscent of the early days of BLINCYTO, and that give us encouragement that we're on the right track. I'd also point out that we undoubtedly have the largest experience in the world in development of bispecific T-cell engagers. As I noted in my remarks, we've learned an enormous amount about dosing and scheduling, appropriate management of adverse events. And I think all of that is starting to come to bear right now, and we're starting to see some of these hints in the HLE or half-life extended format. So again, I'm not ready to declare victory, but we're seeing signs of encouragement, and we'll be ready to share some of those data as the year goes on.

    是的。謝謝你,馬特。我想應該有人會注意到這句話。所以我想說的是,我還不認為有任何跡象表明我已經取得了勝利。但我們看到了與 BLINCYTO 早期相似的藥效活性和早期抗腫瘤活性跡象,這讓我們感到鼓舞,相信我們走在正確的道路上。我還要指出,我們無疑擁有世界上雙特異性 T 細胞銜接器開發最豐富的經驗。正如我在演講中提到的,我們已經學到了大量關於劑量和給藥時間安排、以及不良事件的適當管理方面的知識。我認為所有這些現在都開始顯現效果了,我們開始在 HLE 或半衰期延長格式中看到一些跡象。所以,我再次重申,我還沒有準備好宣布勝利,但我們看到了一些令人鼓舞的跡象,隨著時間的推移,我們將準備好分享其中的一些數據。

  • Operator

    Operator

  • And our next question is from line of Do Kim from BMO Capital Markets.

    下一個問題來自 BMO 資本市場的 Do Kim。

  • Guyn Kim - Analyst

    Guyn Kim - Analyst

  • Just one on Aimovig. You've talked previously about expanding the primary care prescribing base. How would you go about doing that? And could you do it with your current sales force?

    Aimovig 上只有一例。您之前曾談到擴大基層醫療處方群。你會如何著手去做這件事?你能用現有的銷售團隊做到嗎?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Do. We are doing it with our current sales force. I think I talked about the 33,000 prescribing base. And I think we're seeing some encouraging results. Right now, in the CGRP class, you see about 7,000 new patients coming into the class and into the category that are receiving a CGRP therapy. And it's our goal to broaden that, given that there are so many patients who are persisting on oral therapies and older therapies that are just not as effective. And in fact, we see very high drop off and very low persistency on these older oral meds like topiramate. And we're trying to change that care continuum, that pathway and the way physicians treat chronic migraine sufferers, and I think we're having some success. So the 7,000-patient per week number that we're seeing is one that we're looking to grow, and we are applying all the right efforts both in our digital campaigns as well as our personal selling teams in the primary care community right now. So yes, the answer is we have all the resources required to do that.

    是的。謝謝,Do。我們正在利用現有的銷售團隊來完成這項工作。我想我之前提到過33000個處方用戶。我認為我們看到了一些令人鼓舞的結果。目前,在 CGRP 類患者中,約有 7,000 名新患者加入接受 CGRP 治療的類別。我們的目標是擴大治療範圍,因為有許多患者堅持使用口服療法和療效不佳的舊療法。事實上,我們發現像托吡酯這樣的老一輩口服藥物的用藥率下降幅度非常大,堅持用藥率非常低。我們正在努力改變這種護理連續性、這種路徑以及醫生治療慢性偏頭痛患者的方式,我認為我們取得了一些成功。因此,我們目前每週看到的 7000 名患者數量是我們希望增長的數字,我們正在透過數位行銷活動以及初級保健領域的個人銷售團隊,盡一切努力來實現這一目標。所以,答案是肯定的,我們擁有完成這項工作所需的一切資源。

  • Operator

    Operator

  • And our next question is from the line of Yaron Werber from Cowen & Company?

    我們的下一個問題來自 Cowen & Company 的 Yaron Werber 嗎?

  • Yaron Benjamin Werber - MD & Senior Biotechnology Analyst

    Yaron Benjamin Werber - MD & Senior Biotechnology Analyst

  • If you don't mind, Dave, I just have a quick housekeeping and then a question for Murdo. On the housekeeping side, omecamtiv, can you just let us know, is there 1 more final DSMB look before you look at the event rate? And then for Murdo, just curious about Repatha, it looks like it's beginning to grow now. But now what's your expectation given that 70% of patients now have access to the new price -- the new formulation.

    戴夫,如果你不介意的話,我先簡單處理一下家務,然後問默多一個問題。omecamtiv,關於後台管理方面,您能否告知我們,在查看事件發生率之前,是否還需要進行一次最終的 DSMB 檢查?至於 Murdo,我只是對 Repatha 很好奇,看起來它現在開始發展壯大了。但現在,70% 的患者都能享受新的價格和新的配方,你對此有何期待?

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes, Yaron. So I'll take the omecamtiv question. There is -- as we've previously discussed, there's an interim analysis for efficacy that will occur. That has a very, very high bar, a very high bar in terms of the statistical stopping rule. So our expectation is that the trial will continue through to the primary analysis towards the end of the year.

    是的,亞倫。那我就來回答 omecamtiv 的問題吧。正如我們之前討論過的,將會進行一次中期療效分析。這在統計停止規則方面有著非常非常高的標準。因此,我們預計試驗將持續到年底進行主要分析。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. And Yaron, on Repatha. Just a reminder, 100% of patients are accessing the low list price because we pulled the original list price off the market in December. And we've been able to, throughout the course of 2019, open up the commercial access, where the majority of patients receive Repatha by their physicians prescribing it without the need for paperwork and utilization management criteria. So for physician attestation only in commercial is the majority condition for how they can prescribe Repatha. And then in the Medicare Part D space, obviously, that's a new event for us because we were mid-cycle when we lowered the price with the introduction of a low list price. So it's really something we're excited about as an accelerating potential for Repatha. As was mentioned, roughly 70% Medicare Part D lives now have access to Repatha and affordable co-pay. So we're looking forward to seeing sustained growth going forward. Our teams are ready. And I was just with our sales forces in Dallas, and everybody is pretty excited about being able to treat more patients, quite frankly, the way they should have been treated all along.

    是的。還有亞倫,騎著雷帕莎。再次提醒,由於我們在 12 月將原價從市場上撤下,因此 100% 的患者都能享受到較低的價格。2019 年,我們得以開放商業管道,大多數患者可以透過醫生的處方獲得 Repatha,而無需填寫文件和遵守使用管理標準。因此,醫生只有在商業處方中發出證明才能開立 Repatha 處方,這是大多數情況下的必要條件。而在 Medicare Part D 領域,這顯然對我們來說是一個新的事件,因為我們是在周期中期透過引入低價標價來降低價格的。因此,我們對此感到非常興奮,認為這可能是 Repatha 發展的加速潛力。如前所述,目前約有 70% 的 Medicare Part D 受保人可以獲得 Repatha 治療,並且只需支付較低的共付額。因此,我們期待未來能夠持續成長。我們的團隊已經準備就緒。我剛剛和我們在達拉斯的銷售團隊在一起,坦白說,每個人都非常興奮能夠以他們一直以來都應該得到的方式去治療更多的病人。

  • Operator

    Operator

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

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

  • Geoffrey Craig Porges - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

  • A quick housekeeping and then one for Murdo. First, could you just give us an update, Dave, on where the C5 biosimilar program is? Is that still active? And then for Murdo, I know you -- I'm impressed with the EVENITY number. You're annualizing at sort of $350 million already, which I think is better than most of us anticipated. Could you talk a little bit about the reception you're receiving and whether you really think this can become? FORTEO is obviously losing its exclusivity. Can it become a FORTEO-like brand, given what you're seeing already?

    先簡單收拾一下,然後給默多做點事。戴夫,首先你能為我們介紹一下C5生物相似藥計畫的進展嗎?這個服務現在還有效嗎?至於 Murdo,我知道你——我對 EVENITY 的數字印象深刻。你們的年收入已經達到 3.5 億美元左右,我認為這比我們大多數人預期的要好。您能否談談您目前受到的反響,以及您是否真的認為這件事能夠成功?FORTEO 顯然正在失去其獨特性。就目前所見,它有可能成為像 FORTEO 那樣的品牌嗎?

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes, Jeff, so I'll take the first part of that question relating to ABP 959 or Soliris biosimilar. That Phase III is actively enrolling, and we'll provide guidance as we come to the conclusion of that trial when you can expect to see data.

    是的,傑夫,那麼我將回答關於 ABP 959 或 Soliris 生物相似藥的第一部分問題。這個 III 期試驗正在積極招募受試者,我們將在試驗結束時提供指導,屆時您可以看到相關數據。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. And Geoffrey, thanks for the question on EVENITY. We are pleased with the launch trajectory on EVENITY. It's reflective, really, of 2 markets, Japan and U.S., primarily. The Japanese launch has been nothing short of a resounding success there. With our partners Astellas and UCB, I think physician reception has been excellent. We've positioned the product for post fracture high-risk patients. And I think that, that's gone really well, and it's where the risk-benefit equation seems to be one that most physicians are accepting off. And we've done the same thing in the U.S. Our launch is a little younger in the U.S. but nonetheless, the trajectory has exceeded our own expectations as well. We just recently got our permanent J code in the U.S., and that's opening up the prescriber base as well. So I do think that we will have a very successful franchise on our hands. And of course, UCB will be commercializing with some help from us across Europe, thanks to the approval with the EMA there. So overall, will there -- will it be as big as a FORTEO? That remains to be seen. We are, I will remind you, slightly less expensive. 30% on the low end, as much as 70% on the high end than our comparators in the category. It's a 12-month duration. So it's not a product that you take for multiple years. It's a 12-month duration. But the new patient acquisition is clearly exciting.

    是的。傑弗裡,謝謝你提出關於 EVENITY 的問題。我們對 EVENITY 的發射軌跡感到滿意。實際上,這主要反映了日本和美國這兩個市場的情況。在日本的上市取得了巨大的成功。我認為,我們與合作夥伴安斯泰來和優時比的合作,獲得了醫生們的一致好評。我們將產品定位為骨折後高風險患者。我認為這方面進展非常順利,而且大多數醫生似乎都能接受這種風險效益比。我們在美國也做了同樣的事情。雖然我們在美國推出產品的時間稍晚一些,但其發展軌跡也超出了我們自己的預期。我們最近在美國獲得了永久 J 代碼,這也擴大了我們的處方醫生群體。所以我認為我們將會擁有一個非常成功的特許經營品牌。當然,由於歐洲藥品管理局 (EMA) 的批准,UCB 將在歐洲進行商業化,而我們也將提供一些幫助。所以總的來說,它會像 FORTEO 一樣大嗎?這一點還有待觀察。我還要提醒您,我們的價格稍微便宜一點。低階產品比同類產品高出 30%,高階產品比同類產品高出 70%。為期12個月。所以它不是一種需要長期服用的產品。為期12個月。但新患者的取得顯然令人振奮。

  • Operator

    Operator

  • 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。

  • Alethia Rene Young - Head of Healthcare Research

    Alethia Rene Young - Head of Healthcare Research

  • I guess part of it is another drug that's been doing quite well in spite of Sensipar. So maybe can you talk about -- should we expect continued kind of unit demand growth? I know you probably had some contracting, obviously, over the prior 12 months, but just maybe help us frame how to think about the next 12 months for Parsabiv.

    我猜部分原因是另一種藥物儘管Sensipar上市,但​​表現依然相當不錯。那麼,您能否談談-我們是否應該預期單位需求會持續成長?我知道在過去的 12 個月裡,你們可能經歷了一些收縮,但或許可以幫我們規劃 Parsabiv 未來 12 個月的發展方向。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Alethia. The Parsabiv performance last year was fantastic. There are a number of patients who are benefiting from it. There is a change in reimbursement for Parsabiv going into -- coming into 2020 that may slow the rate of growth a little, but the range of possible outcomes is broad and it's really too early to call.

    是的。謝謝你,阿萊西亞。去年帕爾薩比夫的演出非常精彩。很多患者都從中受益。2020 年 Parsabiv 的報銷政策有所變化,這可能會稍微減緩其成長速度,但可能的結果範圍很廣,現在下結論還為時過早。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Ian, I think we've got 2 more calls. Why don't we try to get them, and then we'll wrap up.

    好的。伊恩,我想我們還有兩通電話。我們不妨試著把他們弄到手,然後就結束吧。

  • Operator

    Operator

  • 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。

  • Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research

    Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research

  • Just one for me on omecamtiv. David, you mentioned that the landscape will be changing, you believe, based on some of the recent data. And I guess what I was looking for some clarity on when I presume you're talking about the SGLT2 space, specifically dapagliflozin. And then from the commentary you provided, are you envisioning this to be -- omecamtiv to be on top of SGLT2s or competing at the head? And if there's any SGLT2 patients actually getting enrolled in the trial.

    我在omecamtiv上只買了一個。大衛,你提到根據最近的一些數據,你認為格局將會改變。我想請教一下,您指的是 SGLT2 類藥物,特別是達格列淨嗎?根據您提供的評論,您認為 omecamtiv 的目標是超越 SGLT2 抑制劑,還是與之競爭領先地位?如果真的有SGLT2病人入組試驗的話。

  • David M. Reese - Executive VP of Research & Development

    David M. Reese - Executive VP of Research & Development

  • Yes. Thanks, Salim. Yes, so I was making reference to the SGLT2s, in particular. Our sense is that the patients treated in those studies were probably a somewhat less sick population, so that may be a point of differentiation. And then as we have intended all along with omecamtiv, given the lack of drug-drug interactions that we've seen now and the mechanism of action, it is intended to be an add-on to other therapies. Of course, in the Phase III trial, we will look at the number of patients who are receiving things such as SGLT2s in the study.

    是的。謝謝你,薩利姆。是的,我特別指的是SGLT2受體。我們的感覺是,那些研究中接受治療的患者可能病情相對較輕,所以這可能是個區別點。而且,正如我們一直以來對 omecamtiv 的設想,鑑於我們目前尚未發現藥物交互作用,以及其作用機制,它旨在作為其他療法的補充。當然,在 III 期試驗中,我們將觀察研究中接受 SGLT2 等藥物治療的患者人數。

  • Operator

    Operator

  • And our final question is from the line of Cory Kasimov from JPMorgan. Cory?

    最後一個問題來自摩根大通的科里·卡西莫夫。科里?

  • Gavin Scott - Analyst

    Gavin Scott - Analyst

  • This is Gavin on for Cory. And I apologize if you answered this, but we are wondering what your assumptions are going into the double-digit growth for Otezla. Does this imply label expansion? Or is this just with the existing label? And/or any comments on competitive concerns?

    這裡是加文替科里報道。如果您已經回答過這個問題,我深表歉意,但我們想知道您對 Otezla 實現兩位數成長的假設是什麼。這是否意味著標籤擴展?還是這只是沿用現有的標籤?關於競爭方面的任何問題,您有什麼看法?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Yes. I think we've addressed that. But why don't we just reiterate for you, Gavin, what we think is behind that.

    是的。我認為我們已經討論過這個問題了。但我們不妨再向你重申一遍,加文,我們認為背後的原因是什麼。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. So we are assuming that we would secure additional indications in our assumption for double-digit going forward. We are also using historical growth rate, where we're sourcing new patients right now. So I think that's pretty clear.

    是的。因此,我們假設我們將獲得更多跡象表明,未來兩位數的成長預期將會實現。我們也使用了歷史成長率,來衡量我們目前正在獲取新患者的情況。所以我覺得這一點很清楚了。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay, everyone. Thanks for your patience. Sorry, we went a little bit past the allotted hour. But let me just conclude by saying that we feel good about where we ended in 2019, managing through what was always going to be a transition year for us. And we think we're on the cusp now of a period of new product revenue growth. So we look forward to that, and we look forward as well to the important clinical data that is expected, particularly towards the second half of this year. So I'd be remiss if I didn't just take a moment to thank as well the Amgen staff around the world who continue to work so hard every day to deliver on our mission to serve patients. So thank you to them, and we look forward to having a chance to talk to all of you in April after the first quarter. Thanks.

    好了,各位。感謝您的耐心等待。抱歉,我們稍微超時了。最後我想說的是,我們對 2019 年的最終結果感到滿意,順利度過了對我們來說注定是過渡的一年。我們認為,我們正處於新產品收入增長期的開端。因此,我們對此充滿期待,也期待即將公佈的重要臨床數據,特別是今年下半年即將公佈的數據。因此,如果我不花點時間感謝安進公司世界各地的員工,感謝他們每天辛勤工作,履行我們服務患者的使命,那就太失職了。所以,非常感謝他們,我們期待在第一季結束後,也就是四月有機會與大家交流。謝謝。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Thanks, Bob. Thanks, everybody, for your participation. If you have any other questions you would like to cover, of course, myself and the rest of the IR team will be around for several hours. Have a good day.

    謝謝你,鮑伯。謝謝大家的參與。如果您還有其他問題想要諮詢,我和投資人關係團隊的其他成員將在接下來的幾個小時內隨時為您解答。祝你有美好的一天。

  • Operator

    Operator

  • Ladies and gentlemen, this does conclude Amgen's Fourth Quarter 2019 Financial Results Conference Call. We thank you for your -- joining us. You may now disconnect.

    女士們、先生們,安進公司2019年第四季財務業績電話會議到此結束。感謝您的參與。您現在可以斷開連線了。