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'll be your conference facilitator today for Amgen's First Quarter 2020 Financial Results Conference Call. (Operator Instructions)
我叫伊恩,今天我將擔任安進公司 2020 年第一季財務業績電話會議的主持人。(操作說明)
I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.
現在我謹向大家介紹投資人關係副總裁 Arvind Sood。蘇德先生,您可以開始了。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Okay. Thanks, Ian. Good afternoon, everyone. Thanks for joining us for our Q1 call. I hope you and your families are staying safe. We are
好的。謝謝你,伊恩。大家下午好。感謝您參加我們第一季電話會議。希望您和您的家人平安健康。我們是
(technical difficulty)
(技術難題)
with the COVID-19 pandemic. I know I speak on behalf of all my colleagues at Amgen when I say that it's a source of great pride that we work in an industry that can be a part of the solution.
以及新冠肺炎疫情。我知道我代表安進公司的所有同事說,我們身處一個能夠成為解決方案一部分的行業,這讓我們感到非常自豪。
Before we start, I would like to recognize those who are new in their coverage of Amgen, including Tim Anderson of Wolfe Research, Carter Gould of Barclays and Michael Schmidt of Guggenheim. Welcome.
在開始之前,我想特別感謝那些新近開始報道安進公司的人士,包括 Wolfe Research 的 Tim Anderson、巴克萊銀行的 Carter Gould 和 Guggenheim 的 Michael Schmidt。歡迎。
Over the past few weeks, I've talked with many of you, and you have expressed concerns and posed questions about how this COVID pandemic will impact our business, including supply chain, clinical trials, commercial operations and growth outlook. As our growth outlook will be defined by how these variables unfold in the future, we have modified the order of presenters today, so you can get a good sense of how we are dealing with the uncertainties and remedial actions we are taking to run our business effectively.
在過去的幾周里,我和你們中的許多人進行了交談,你們表達了對此次 COVID 疫情將如何影響我們業務的擔憂,並提出了相關問題,包括供應鏈、臨床試驗、商業運營和增長前景。由於我們的成長前景將取決於這些變數在未來的發展情況,我們調整了今天演講者的順序,以便您能更好地了解我們是如何應對不確定性以及我們為有效運營業務而採取的補救措施的。
Our CEO, Bob Bradway, will commence the call with some opening comments, followed by our Head of R&D, Dave Reese, who will provide a pipeline update. Our Head of Commercial operations, Murdo Gordon, will give you a state of the business. And then our CFO, Peter Griffith, will bring it all together by helping you understand what all this means in terms of our growth outlook.
我們的執行長鮑勃·布拉德韋將首先發表一些開場白,隨後我們的研發主管戴夫·里斯將介紹研發管線的最新進展。我們的商務營運主管默多‧戈登將向您報告公司業務狀況。然後,我們的財務長彼得·格里菲斯將把所有這些資訊匯總起來,幫助大家了解這一切對我們的成長前景意味著什麼。
By the way, consistent with the recommendations for social distancing, we are all in different locations today. So please bear with us as we are doing the best we can.
順便一提,為了回應保持社交距離的建議,我們今天都身處不同的地方。所以請大家耐心等待,我們正在盡力做到最好。
Just a quick reminder that we'll use non-GAAP financial measures in today's presentation, and some of the statements will be forward-looking statements. I would direct you to our 10-K and subsequent filings which identify factors that could cause our actual results to differ materially.
提醒一下,我們今天的演示將使用非GAAP財務指標,其中一些陳述屬於前瞻性陳述。我建議您查閱我們的 10-K 表格及後續文件,其中列出了可能導致我們實際業績與預期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. Good afternoon, everyone. I want to acknowledge upfront that this has been an extraordinary quarter for all of us, global pandemic, economic disruption like none of us have seen before and, of course, financial volatility that has been dizzying at times. But I hope you're keeping well, and we're certainly grateful to you for joining the call.
好的。大家下午好。首先我要承認,對我們所有人來說,這都是一個非同尋常的季度,全球疫情肆虐,經濟動盪前所未見,當然還有令人眼花繚亂的金融波動。但我希望你一切安好,我們非常感謝你參加這次通話。
(technical difficulty)
(技術難題)
results, we're managing through the COVID disruption quite well and feel we're operating from a position of strength, with a healthy balance sheet, a strong portfolio of products,and an organization that has proven itself time and again to be innovative, resilient and able to adapt quickly to changing circumstances.
結果顯示,我們應對 COVID 疫情帶來的衝擊相當順利,並且感覺我們正處於有利地位,擁有健康的資產負債表、強大的產品組合,以及一個一次又一次證明自己具有創新性、韌性和能夠快速適應不斷變化的環境的組織。
I want to take a few moments to share how we've been responding to COVID-19, and then we can dive into the details of the first quarter and what we see for the remainder of the year. We've mobilized our company around 4 priorities: first, taking care of our staff, our 23,000 staff around the world; second, continuing to serve patients with an uninterrupted supply of our commercial and clinical medicines; third, leveraging our core genetics, immunology and antibody expertise in the fight against COVID-19; and finally, supporting the communities where we live and work.
我想花幾分鐘時間分享我們是如何應對 COVID-19 的,然後我們可以深入探討第一季的細節以及我們對今年剩餘時間的展望。我們圍繞著以下四個優先事項調動了公司:第一,照顧好我們的員工,我們在全球擁有 23,000 名員工;第二,繼續為患者提供不間斷的商業和臨床藥物供應;第三,利用我們在遺傳學、免疫學和抗體方面的核心專業知識來對抗 COVID-19;最後,支持我們生活和工作的社區。
Our first priority from the beginning of the pandemic has been to ensure the safety of our people and their families. To encourage social distancing, Amgen staff worldwide are mostly working from home now. We're encouraged that in a few markets, conditions have improved to the point where we've begun returning our people to the workplace, and we hope to expand our back-to-the-workplace activities in the coming
自從疫情爆發以來,我們的首要任務一直是確保員工及其家人的安全。為鼓勵維持社交距離,安進公司全球員工目前大多在家工作。我們很欣慰地看到,在一些市場,情況已經好轉,我們已經開始讓員工重返工作崗位,我們希望在未來擴大復工範圍。
(technical difficulty)
(技術難題)
I would also note that about 1/4 of our staff are engaged in essential manufacturing and R&D activities that have required them to continue coming to the workplace every day. We're taking every possible measure to keep these employees safe, and we're grateful to them for their commitments to patients and to our business. All our staff are performing really well, as you can see from our results.
我還想指出,我們約有 1/4 的員工從事重要的製造和研發活動,這要求他們每天都要來上班。我們正在採取一切可能的措施來保障這些員工的安全,我們感謝他們對病人和我們公司所做的貢獻。從我們的成績可以看出,我們所有員工的表現都非常出色。
At a time when health care systems around the world are being stretched to their limits, we're committed to working collaboratively with our partners in the health care ecosystem. We need to make sure that we're both responding to COVID-19 and meeting the ongoing needs of other seriously ill patients
在世界各地醫療保健系統都面臨極限挑戰之際,我們致力於與醫療保健生態系統中的合作夥伴合作。我們需要確保既能應對新冠肺炎疫情,又能滿足其他重症患者的持續需求。
(technical difficulty)
(技術難題)
health care crisis that we as a society never intended. From a supply chain perspective, we've not experienced any significant disruptions, and we don't currently anticipate any shortages of our medicines due to COVID-19.
這是我們整個社會從未預料到的醫療危機。從供應鏈的角度來看,我們沒有遇到任何重大中斷,目前我們預計不會因為 COVID-19 而出現藥品短缺。
With respect to clinical trials, our pivotal studies, including for AMG 510, Otezla, tezepelumab and omecamtiv mecarbil are fully enrolled and expected to read out this year, as previously announced. Other programs such as our BiTE's and oncology have also continued to progress, and we're encouraged by the accumulating data there. Where programs have been interrupted by the COVID pandemic, we're busy making plans to get them restarted as soon as appropriate from a patient safety and regulatory perspective.
關於臨床試驗,我們的關鍵性研究,包括 AMG 510、Otezla、tezepelumab 和 omecamtiv mecarbil 的研究,都已完成招募,預計將於今年公佈結果,正如先前宣布的那樣。其他項目,例如我們的 BiTE 和腫瘤學項目,也一直在取得進展,我們對這些項目累積的數據感到鼓舞。受新冠疫情影響而中斷的項目,我們正在積極制定計劃,以便在確保患者安全和符合監管規定的情況下盡快重啟。
By now, it's clear that overcoming this pandemic will require innovative science. While the virus may have gotten the jump on us at the outset, the good news is that the community of innovative biopharmaceutical companies is moving at a speed and scale never seen before, and we're gaining ground on the virus with each passing day. While our research does not include antivirals, we have a role to play in this battle, leveraging our genetics, immunology and antibody expertise to do so.
現在看來,戰勝這場疫情顯然需要創新科學。雖然病毒可能在初期搶佔了先機,但好消息是,創新生物製藥公司群體正以前所未有的速度和規模行動,我們每天都在戰勝病毒。雖然我們的研究不包括抗病毒藥物,但我們可以在這場戰役中發揮作用,利用我們的遺傳學、免疫學和抗體專業知識來實現這一目標。
As previously announced, we're harnessing the molecular epidemiology work done by our deCODE subsidiary and working with our partners at Adaptive Biotechnologies to develop an antibody to prevent or treat COVID-19. If we're successful, our industry-leading manufacturing capabilities will play an important role in helping us meet the needs of patients.
正如先前宣布的那樣,我們正在利用我們 deCODE 子公司所做的分子流行病學工作,並與我們的合作夥伴 Adaptive Biotechnologies 合作,開發一種抗體來預防或治療 COVID-19。如果我們成功,我們領先業界的製造能力將在幫助我們滿足患者需求方面發揮重要作用。
In addition, based on its mechanism of action, Otezla might help prevent the respiratory distress seen in late-stage COVID patients. As Dave Reese will explain in a moment, we'll be exploring this question in clinical trials imminently.
此外,根據其作用機制,Otezla 可能有助於預防新冠肺炎晚期患者出現的呼吸窘迫。正如戴夫·里斯稍後將解釋的那樣,我們將很快在臨床試驗中探討這個問題。
We've long prioritized being a good citizen within the health care ecosystem and within the communities where we live and work.
我們一直以來都將在醫療保健生態系統以及我們生活和工作的社區中做一個好公民放在首位。
(technical difficulty)
(技術難題)
by COVID-19 has been devastating for many. While we certainly have been impacted by the pandemic at Amgen, we recognize that we're in a fortunate position, and we're committed to doing our part to help during this time of need. Toward that end, the Amgen Foundation is supporting COVID-19 in a variety of ways, with a focus on communities where we have a significant presence. To give you just one example, we donated testing equipment in Ventura County, our home county, that effectively has doubled the testing capacity for COVID-19 here.
新冠疫情給許多人帶來了毀滅性的打擊。雖然安進公司確實受到了疫情的影響,但我們意識到自己處於一個幸運的位置,我們致力於在這個需要幫助的時刻盡自己的一份力。為此,安進基金會正以多種方式支持 COVID-19 的抗擊工作,並專注於我們擁有重要業務的社區。舉個例子來說,我們向我們所在的文圖拉縣捐贈了檢測設備,有效地使這裡的 COVID-19 檢測能力翻了一番。
Looking forward, we're confident in the future. We were in a strong position heading into the COVID-19 pandemic, and we expect to stay strong as we come through the other side of this. We remain focused on delivering sustained long-term growth, and we're confident in our outlook for that. As I've already noted, we have a number of important innovative medicines advancing in our pipeline, and the key programs remain on track from a timing perspective.
展望未來,我們對未來充滿信心。在新冠疫情爆發之前,我們處於有利地位,我們預計在疫情後也能保持這種優勢。我們將繼續專注於實現持續的長期成長,並且對前景充滿信心。正如我之前提到的,我們有許多重要的創新藥物正在研發中,從時間安排上看,關鍵項目仍然按計劃進行。
Our integration of Otezla has been seamless. In Japan, we have now successfully completed the integration of our Astellas partnership. And we're already well advanced and collaborating effectively with our colleagues at BeiGene in China. All this gives me confidence that we're executing effectively around the world despite the challenges of COVID-19. Finally,
我們與 Otezla 的整合非常順利。在日本,我們現在已經成功完成了與安斯泰來集團的合作整合。我們目前已取得良好進展,並與我們在中國的百濟神州的同事們進行了有效的合作。所有這些都讓我相信,儘管面臨新冠疫情的挑戰,我們在全球範圍內仍然能夠有效地執行各項任務。最後,
(technical difficulty)
(技術難題)
a fact that will enable us to continue our capital allocation principles, which to remind you are to invest in innovation internally and externally while returning significant capital to our shareholders.
這一事實將使我們能夠繼續執行我們的資本配置原則,再次提醒各位,我們的資本配置原則是在內部和外部投資創新,同時向股東返還大量資本。
Though the pandemic is still very fluid, and to be sure, the first few weeks of April have clearly shown some signs of disruption, the combination of our results from the first quarter and our expectation of an improving outlook for global health care activity give us confidence that the guidance we provided earlier in the year still incorporates the likely range of outcomes for our business in 2020. Peter will give you more color on this shortly.
儘管疫情情況仍然瞬息萬變,而且可以肯定的是,4 月的前幾週已經明顯出現了一些混亂跡象,但我們第一季的業績以及我們對全球醫療保健活動前景改善的預期,使我們有信心,我們年初提供的指導仍然包含了我們業務在 2020 年可能取得的成果範圍。彼得稍後會為你詳細介紹。
Amgen's strength has always come from its people. Like me, they believe in the power of science to make a difference in the world. We often talk about this being the biocentury, the golden age of innovation for biology. We may have met our challenge of the century in SARS-CoV-2, but I hope, however bleak this pandemic may seem at times, that all of you share our optimism that this virus will ultimately yield to the relentless efforts of the biopharmaceutical industry and wrestle it to ground. I'm proud of the team at Amgen for coming together to support each other and all those we serve during such a challenging time. I'm proud also of the work we are doing with our industry colleagues to tackle the COVID-19 challenge.
安進的優勢一直來自於其員工。和我一樣,他們也相信科學的力量能夠改變世界。我們常說這是生物世紀,是生物學創新的黃金時代。我們或許已經遇到了本世紀最大的挑戰——SARS-CoV-2,但我希望,無論這場疫情有時看起來多麼黯淡,你們都能和我們一樣樂觀地認為,這種病毒最終會在生物製藥行業的不懈努力下屈服,並被徹底消滅。我為安進團隊感到驕傲,在這個充滿挑戰的時期,他們團結一致,互相支持,也支持我們服務的所有人。我也很自豪我們與業內同行共同努力應對 COVID-19 的挑戰。
With that, let me turn over to Dave Reese, who will provide a pipeline update. Dave?
接下來,我將把麥克風交給戴夫·里斯,他將為大家帶來管道方面的最新情況。戴夫?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Bob, and good afternoon, everyone.
謝謝你,鮑勃,大家下午好。
In light of the evolving COVID-19 epidemic, the structure of today's R&D update will differ from my usual approach. Some of the first quarter highlights can be found within our press release and accompanying presentation, and of course, I'll be happy to address questions on any other aspects of our pipeline following our general comments. I don't have to tell you that we're in the midst of the biggest public health crisis of our lifetimes,which presents unprecedented challenges in patient care and clinical development. Therefore, today, my comments will focus primarily on our R&D operations and clinical trial execution in the current environment, where our first principle is to ensure the safety and well-being of patients and health care providers taking part in our clinical trials.
鑑於新冠肺炎疫情的不斷變化,今天研發進展報告的結構將與我通常的做法有所不同。第一季的一些亮點可以在我們的新聞稿和隨附的演示文稿中找到,當然,在我們的總體評論之後,我將很樂意回答有關我們產品線其他方面的任何問題。無需贅言,我們正處於一生中最大的公共衛生危機之中,這對病患照護和臨床開發帶來了前所未有的挑戰。因此,今天我的發言將主要集中在我們當前環境下的研發運作和臨床試驗執行情況上,我們的首要原則是確保參與我們臨床試驗的患者和醫療保健提供者的安全和福祉。
With respect to key late-stage trials that are scheduled to read out this year, we have been working closely with our collaborators at AstraZeneca and Cytokinetics on the execution of our pivotal studies for tezepelumab and omecamtiv mecarbil, respectively, both of which have completed enrollment. We currently do not expect any significant delays and continue to expect completion of these studies this year. We believe we will have high-quality data from both of these trials.
對於計劃於今年公佈結果的關鍵後期試驗,我們一直在與阿斯特捷利康和 Cytokinetics 的合作者密切合作,執行 tezepelumab 和 omecamtiv mecarbil 的關鍵性研究,這兩項研究均已完成入組。我們目前預計不會有任何重大延誤,並繼續預計這些研究將於今年完成。我們相信這兩項試驗都將獲得高品質的數據。
This is also the case with our potentially pivotal Phase II monotherapy study for AMG 510, now known as sotorasib, in advanced non-small cell lung cancer, which is also fully enrolled. As I mentioned last quarter, we will be collecting at least 6 months of response data in these patients and continue to expect these results later this year.
我們正在進行一項針對晚期非小細胞肺癌的 AMG 510(現稱為 sotorasib)的潛在關鍵性 II 期單藥治療研究,目前該研究也已完成全部受試者招募。正如我上個季度提到的,我們將收集這些患者至少 6 個月的反應數據,並繼續期待今年稍後獲得這些結果。
I would note that the Phase III trial of Otezla in mild to moderate psoriasis also remains on track, and we expect data from that study in the coming weeks.
我注意到,Otezla 治療輕度至中度乾癬的 III 期試驗也仍在按計劃進行,我們預計將在未來幾週內獲得該研究的數據。
As previously disclosed, we have temporarily paused enrollment in clinical trials where there is uncertainty around the ability of sites to ensure subject safety or data integrity. Patients already enrolled in our studies continue to receive study drug, and we remain focused on supporting our clinical investigators to ensure appropriate care of these patients in a safe manner consistent with clinical site and agency guidelines. We're actively working with regulators and implemented study procedures as appropriate that are consistent with the recent FDA guidelines, including remote monitoring, virtual follow-up, alternative locations for assessment and home delivery of investigational product. We continue to make decisions study-by-study and site-by-site to minimize risk to the patients in facilities and to maintain trial integrity.
正如先前所揭露的那樣,如果臨床試驗中心無法確保受試者的安全或數據的完整性,我們將暫時停止招募受試者。已入組我們研究的患者將繼續接受研究藥物,我們將繼續專注於支持我們的臨床研究人員,以確保按照臨床試驗中心和機構指南,以安全的方式對這些患者進行適當的護理。我們正在積極與監管機構合作,並根據 FDA 最近的指導方針,酌情實施研究程序,包括遠端監測、虛擬追蹤、替代評估地點和研究產品送貨上門。我們繼續逐一研究、逐一地點做出決定,以最大限度地降低患者在醫療機構中面臨的風險,並維護試驗的完整性。
For example, enrollment continues in certain studies where there is the potential for significant benefit in a serious life-threatening conditions and where site resources allow new patients to be safely enrolled and closely monitored. Such trials include but are not -- certainly not limited to our HLE or half-life extended BiTE programs targeting BCMA, DLL3 and PSMA. And we look forward to sharing data from these studies later this year.
例如,在某些可能對危及生命的嚴重疾病帶來顯著益處的研究中,如果研究中心的資源允許安全地招募新患者並對其進行密切監測,則繼續招募患者。此類試驗包括但不限於我們的 HLE 或半衰期延長 BiTE 項目,這些項目針對 BCMA、DLL3 和 PSMA。我們期待在今年稍後分享這些研究的數據。
In other studies, such as our sotorasib Phase I combination study with KEYTRUDA and the Phase III confirmatory study, where we have paused enrollment to ensure patient safety, time lines may be impacted, and I'll provide updates as the situation develops and we gain more clarity. There is ongoing interest from investigators to provide their patients' access to investigational therapies with potential for significant benefit. And we are working to continue study start-up activities for sotorasib and across our entire portfolio to allow rapid site activation. We look forward to resuming enrollment in paused studies and initiating subjects enrollment in new studies over the coming weeks and months as soon as it is safe and feasible to do so.
在其他研究中,例如我們與 KEYTRUDA 聯合進行的 sotorasib I 期研究和 III 期確證性研究,由於我們已暫停招募以確保患者安全,時間表可能會受到影響,隨著情況的發展和我們獲得更多明確信息,我將提供最新消息。研究人員一直致力於讓患者有機會獲得可能帶來顯著益處的試驗性療法。我們正在努力繼續推進 sotorasib 以及我們整個產品組合的研究啟動活動,以便快速啟動試驗點。我們期待在未來幾週和幾個月內,一旦安全可行,就恢復暫停的研究的受試者招募工作,並啟動新研究的受試者招募工作。
As we look forward to this year's clinical study readouts, we will be working with representatives of medical conferences and journals to ensure continued dissemination of important data to the medical community in a peer-reviewed environment as we anticipate that many congresses will be virtual through the end of 2020. In any case, we have provided -- we are committed to providing data updates in a timely manner. We're also continuing to prioritize programs across our preclinical and clinical portfolios, as you might expect. For instance, based on the progress of our half-life extended BiTE molecules, we have stopped development of the first-generation continuous infusion, PSMA and BCMA BiTE programs.
展望今年的臨床研究結果,我們將與醫學會議和期刊的代表合作,確保在同行評審的環境下繼續向醫學界傳播重要數據,因為我們預計到 2020 年底,許多大會都將以虛擬形式舉行。總之,我們已經承諾及時提供數據更新。正如您所預料的那樣,我們也將繼續優先考慮臨床前和臨床項目組合中的各項計劃。例如,基於我們半衰期延長的 BiTE 分子的進展,我們已經停止了第一代連續輸注、PSMA 和 BCMA BiTE 項目的開發。
In research, essential work has continued, and we are beginning to ramp laboratory activities across the organization as the situation safely permits in various geographies. I'm also pleased to report that our BeiGene collaboration is on track. And this quarter, we have begun to transition certain functional activities to BeiGene, including nonpromotional activities on the 3 in-line products and some local regulatory responsibilities in China.
在研究方面,必要的科研工作一直在繼續,隨著各地情況的安全允許,我們正在逐步擴大整個組織的實驗室活動。我很高興地報告,我們與百濟神的合作進展順利。本季度,我們已開始將某些職能活動轉移給百濟神州,包括 3 款在售產品的非推廣活動以及在中國的一些本地監管職責。
I'd like to close by saying a few words about how we are leveraging our expertise in therapeutic antibody development and immunology in the fight against COVID-19. Our recently announced collaboration with Adaptive Biotechnologies to identify and develop neutralizing antibodies to the coronavirus from the recovered COVID-19 patients is now actively underway. We view Adaptive's world-class expertise in immune profiling, combined with Amgen's expertise in immunology and antibody engineering and manufacturing, as a unique opportunity to contribute to what is an unprecedented industry response to this pandemic. We are working intently to identify the highest-quality therapeutic candidates as fast as we can, and we'll take advantage of frequent interactions offered by regulatory authorities. In our view, there will likely be more than one generation of antibody therapeutics, and our aim is to develop the highest-possible-quality candidates.
最後,我想簡單談談我們如何利用我們在治療性抗體開發和免疫學方面的專業知識來對抗 COVID-19。我們最近宣布與 Adaptive Biotechnologies 合作,從新冠肺炎復健患者體內識別和開發針對冠狀病毒的中和抗體,目前該合作正在積極進行中。我們認為 Adaptive 在免疫分析方面的世界一流專業知識,結合安進在免疫學、抗體工程和製造方面的專業知識,為應對這場前所未有的行業疫情做出了貢獻,這是一個獨特的機會。我們正在全力以赴,盡快確定最高品質的候選治療藥物,並將充分利用監管機構提供的頻繁互動機會。我們認為,抗體療法可能不只一代,我們的目標是開發出最高品質的候選藥物。
In addition to our efforts to develop a therapeutic antibody, we have also been engaged in discussions with multiple groups conducting platform trials in COVID-19 and anticipate that Otezla will enter the clinic in the coming weeks to be investigated as a potential immunomodulatory treatment in adult patients with the disease. Finally, we are contributing actively to collaborative efforts to advance therapeutics for COVID-19, including ACTIV, the public-private partnership with the NIH.
除了我們致力於開發治療性抗體外,我們還與多個正在進行 COVID-19 平台試驗的團隊進行了討論,並預計 Otezla 將在未來幾週內進入臨床階段,作為治療成人 COVID-19 患者的潛在免疫調節療法進行研究。最後,我們正在積極參與推動 COVID-19 治療的合作努力,包括與美國國立衛生研究院 (NIH) 合作的公私合作計畫 ACTIV。
I want to close by acknowledging our staff who are working tirelessly and selflessly under these challenging circumstances to deliver for our patients. Their commitment and execution have been exemplary, and I can't thank them enough.
最後,我要感謝我們的員工,他們在這些充滿挑戰的環境下不知疲倦、無私奉獻地為我們的病人提供服務。他們的敬業精神和執行力堪稱典範,我感激不盡。
I'd now like to turn things over to Murdo Gordon.
現在我想把發言權交給默多‧戈登。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Thanks, Dave, and good afternoon, everyone.
謝謝你,戴夫,大家下午好。
We started the year with strong volume-driven growth of 15% on a global basis, with 10% in the U.S. and 32% ex U.S. Growth was generated broadly across our portfolio of newer products, more than offsetting declines in our mature brands. Given the unprecedented nature of the COVID-19 pandemic, I want to start by sharing our views on how disruptions in the global health care system may impact our business, and then I'll walk through what we're seeing at the product level and what actions we are taking. Like others in our sector, we're seeing varying degrees of impact from COVID-19 across our portfolio as physician-patient interactions are interrupted. These reduced interactions have led to some delays in diagnosis and treatment, which in turn reduces new patient starts. Data from IQVIA suggests that patient office visits have declined by over 50%, although some of this is being offset by telemedicine and telehealth services. Data also show that some patients refilled prescriptions early and that there was a modest benefit of approximately $100 million from inventory in the quarter. Finally, increased utilization of patient affordability programs and changes in segment mix due to increased U.S. unemployment could negatively impact U.S. net prices.
今年年初,我們在全球實現了強勁的銷售成長,增幅達 15%,其中美國成長 10%,美國以外地區成長 32%。成長主要來自我們較新的產品組合,足以抵消成熟品牌的下滑。鑑於 COVID-19 疫情的空前性質,我想先分享我們對全球醫療保健系統中斷可能如何影響我們業務的看法,然後我將詳細介紹我們在產品層面看到的情況以及我們正在採取的行動。與其他同行業的公司一樣,由於醫病互動中斷,我們的投資組合也受到了 COVID-19 不同程度的影響。互動減少導致診斷和治療一些延誤,進而減少了新患者的入院人數。IQVIA 的數據顯示,患者門診就診量下降了 50% 以上,儘管遠距醫療和遠距保健服務在一定程度上抵消了這一影響。數據顯示,一些患者提前續開了處方,並且本季庫存帶來了約 1 億美元的適度收益。最後,由於美國失業率上升,患者負擔能力計畫的增加和細分市場組合的變化可能會對美國淨價格產生負面影響。
Treatments like Prolia that require in-office administration by a health care provider have been negatively impacted. On the other hand, the product like Otezla may benefit given that it provides a convenient oral option for patients compared with injectable or IV biologics, some of which require monitoring. Despite this disruption, our teams are responding to customer needs via remote interactions. We're identifying innovative solutions to help patients, and we're supplying products reliably and consistently.
像Prolia這樣需要醫護人員在診間進行給藥的治療方法受到了負面影響。另一方面,像 Otezla 這樣的產品可能會受益,因為它為患者提供了一種方便的口服選擇,而注射或靜脈注射生物製劑則需要監測。儘管受到疫情影響,我們的團隊仍在透過遠端互動的方式回應客戶需求。我們正在尋找創新的解決方案來幫助患者,我們正在可靠、穩定地供應產品。
Now let me review some product details, beginning with Prolia on Slide 12. Prolia grew 10% year-over-year from higher volume. Strong demand growth in January and February was consistent with prior years. In March, we began to see a negative impact on Prolia in-office injections and have since observed a substantial step-down in utilization versus prior years. In more recent weeks, we're beginning to see signs of stabilization, and we'll be able to provide more clarity on this when we report our Q2 results in July. The importance of treating osteoporosis in patients who are at high risk of fractures is critical. Our teams are working to address continuity of care issues and exploring novel solutions such as alternate sites of care, mobile nurse-administered injections, prescription fills at specialty and retail pharmacies. We're also working with policymakers and advocacy organizations to address treatment challenges in this environment.
現在讓我回顧一些產品細節,先從第 12 張投影片上的 Prolia 開始。Prolia銷量較去年同期成長10%,主要得益於銷售成長。1月和2月的強勁需求成長與往年一致。3 月份,我們開始看到 Prolia 門診注射受到負面影響,此後觀察到其使用率與往年相比大幅下降。最近幾週,我們開始看到穩定的跡象,我們將在7月公佈第二季業績時對此提供更清晰的說明。對於骨折高風險患者而言,治療骨質疏鬆症至關重要。我們的團隊正在努力解決護理連續性問題,並探索新的解決方案,例如替代護理地點、移動護士注射、在專科藥房和零售藥房配藥等。我們也與政策制定者和倡導組織合作,以應對這種環境下的治療挑戰。
Moving to Evenity, which launched in Japan and the U.S. in the first half of 2019. Evenity posted $100 million in sales during the first quarter driven by continued uptake. In Japan, which represents roughly 2/3 of Evenity sales, we've attained shares similar to those of established anabolic therapies. In the U.S., we saw an acceleration in demand trends with improvements in persistence in Q1 as clinics gained more experience. As patients complete their 1-year cycle of therapy with Evenity, we will work with health care providers to help transition these patients to Prolia. Evenity and Prolia are a complementary set of options to address the 9 million fractures that occur worldwide in postmenopausal osteoporosis patients. And our teams are focused on ensuring these patients are not compromised during this pandemic.
轉投 Evenity,該公司於 2019 年上半年在日本和美國推出。受持續成長的市場需求推動,Evenity 第一季銷售額達到 1 億美元。在日本,Evenity 的銷售額約佔其總銷售額的 2/3,我們已獲得與成熟的合成代謝療法類似的市場份額。在美國,隨著診所經驗的積累,我們看到第一季需求趨勢加速成長,患者堅持治療的情況也有所改善。當患者完成為期 1 年的 Evenity 治療週期後,我們將與醫療保健提供者合作,幫助這些患者過渡到 Prolia。Evenity 和 Prolia 是一套互補的治療方案,用於解決全球停經後骨質疏鬆症患者發生的 900 萬例骨折問題。我們的團隊正致力於確保這些患者在此次疫情期間的健康狀況不會受到損害。
Moving to Repatha, we're off to a strong start in 2020. Our efforts over the past 18 months to improve access and affordability have yielded strong results as Q1 sales grew by 62% year-over-year driven by 98% volume growth versus the same period last year. New-to-brand prescriptions in the U.S. steadily improved in Q1, growing 51% year-over-year, and we held 80% market share exiting the quarter. As we presaged in our last earnings call, Part D contracting to improve access and affordability resulted in a step-down in Repatha's net selling price in Q1. We expect net selling price to be relatively stable for the remainder of the year.
在轉投 Repatha 之後,我們在 2020 年取得了強勁的開局。過去 18 個月以來,我們為改善產品的可及性和可負擔性所做的努力取得了顯著成效,第一季銷售額年增 62%,其中銷量年增 98%。美國新品牌處方量在第一季穩定成長,年增 51%,到季末,我們的市佔率達到了 80%。正如我們在上次財報電話會議上預告的那樣,D 部分合約旨在改善醫療服務可近性和可負擔性,導致 Repatha 在第一季的淨售價下降。我們預計今年剩餘時間內淨售價將保持相對穩定。
On to Aimovig on Slide 15. On a year-over-year basis, net sales grew 20% with underlying volume growth of 46%. Aimovig remains the market leader with 48% total prescription share. To date, almost 330,000 patients have been prescribed Aimovig by more than 33,000 prescribers. With the recent addition to CVS national preferred formulary, we now have access to 93% of covered lives, which led to a 19% growth quarter-over-quarter in new-to-brand prescriptions. Net price was sequentially lower due to expanded access with CVS and higher co-pay utilization that occurs each year in the first quarter. These factors were partially offset by the proportion of paid prescriptions increasing to almost 90%, up from 81% in Q4 of 2019.
接下來是第 15 張投影片上的 Aimovig。與去年同期相比,淨銷售額成長了 20%,實際銷量成長了 46%。Aimovig 仍是市場領導者,佔據 48% 的處方藥市場。迄今為止,已有超過 33,000 名醫生為近 33 萬名患者開立了 Aimovig 處方。由於最近加入了 CVS 全國優選處方集,我們現在可以接觸到 93% 的參保人群,這使得新品牌處方數量環比增長了 19%。由於 CVS 擴大了供貨管道,以及每年第一季較高的自付費用,淨價環比下降。這些因素部分被付費處方比例上升至近 90% 所抵消,比例高於 2019 年第四季的 81%。
Next to our inflammation portfolio, starting with Otezla. Integration has been seamless, evidenced by 23% year-over-year growth driven by volume. These results, coupled with planned label expansion, give us confidence in our ability to realize the full global potential of Otezla as an affordable option with a very well-defined efficacy and safety profile. In the current COVID environment, Otezla provides a convenient oral option for patients. It's conducive to telemedicine and does not require lab monitoring.
接下來是我們抗發炎產品組合,首先是 Otezla。整合過程非常順利,銷量較去年同期成長 23% 就證明了這一點。這些結果,加上計劃中的標籤擴展,使我們有信心充分發揮 Otezla 的全球潛力,使其成為一種價格合理、療效和安全性都非常明確的選擇。在目前的 COVID 環境下,Otezla 為患者提供了一種方便的口服治療方案。它有利於遠距醫療,而且不需要實驗室監測。
Moving to Enbrel. Sales were $1.2 billion in Q1 and included a $70 million year-over-year benefit from favorable changes in accounting estimates related to sales deductions. Consistent with prior trends, prescription volumes declined 5% year-over-year. We continue to expect a limited benefit from net selling price in 2020 versus 2019. In this environment, we're supporting Enbrel's strong continuing base of patients in maintaining their course of therapy through disruptions and out-of-pocket cost barriers. As you know, Enbrel has been on the market for over 20 years and does not require routine lab monitoring.
改用恩利(Enbrel)。第一季銷售額為 12 億美元,其中包括因與銷售扣除相關的會計估計有利變化而帶來的 7,000 萬美元年成長收益。與以往趨勢一致,處方量年減 5%。我們仍預期 2020 年淨售價與 2019 年相比帶來的收益有限。在這種環境下,我們正在支持 Enbrel 強大的持續患者群體,幫助他們克服治療中斷和自費障礙,堅持完成治療療程。如您所知,恩利(Enbrel)已上市超過 20 年,無需常規實驗室監測。
Now to Slide 18. Another contributor to our inflammation franchises, AMGEVITA, which for 3 consecutive quarters is the #1 adalimumab biosimilar in Europe, recording $86 million of sales in Q1.
現在來看第18張投影片。我們發炎產品線的另一個貢獻者 AMGEVITA 連續三個季度成為歐洲排名第一的阿達木單抗生物類似藥,第一季銷售額達 8,600 萬美元。
Switching to our hematology and oncology business, our innovative portfolio of 6 brands collectively totaled $1.3 billion in the quarter, growing by 11% year-over-year. Certain products like XGEVA may be impacted in the current environment due to disruptions in physician-patient interactions. Although others, including Neulasta's Onpro and our oncology biosimilars MVASI and KANJINTI provide greater value.
再來看我們的血液腫瘤業務,我們旗下 6 個創新品牌的產品組合在本季總銷售額達 13 億美元,較去年同期成長 11%。由於醫病互動中斷,某些產品(如 XGEVA)在當前環境下可能會受到影響。儘管其他藥物,包括 Neulasta 的 Onpro 和我們的腫瘤生物相似藥 MVASI 和 KANJINTI,提供了更大的價值。
Let me highlight some of our larger products. KYPROLIS grew 14% year-over-year, led by a 21% increase in U.S. sales which was driven by expanded use in second and third-line multiple myeloma. Neulasta declined 40% year-over-year. Recall that Q1 of 2019 benefited from a $98 million BARDA order which did not repeat this quarter.
讓我重點介紹一下我們的一些大型產品。KYPROLIS 年成長 14%,其中美國銷售額成長 21%,這主要得益於其在二線和三線多發性骨髓瘤治療中的應用擴大。Neulasta年減40%。回想一下,2019 年第一季受益於 BARDA 9,800 萬美元的訂單,但本季沒有再次出現這種情況。
Onpro continues to be the preferred choice and has held quarter-over-quarter share at 54% despite facing an additional competitor. The revised NCCN guidelines recommend increased use of G-CSFs to minimize the risk of febrile neutropenia in cancer patients. Onpro provides a unique value proposition particularly now as patients can receive their G-CSF treatment without having to return to their site of care.
儘管面臨新的競爭對手,Onpro 仍然是首選,季度環比市場份額保持在 54%。修訂後的 NCCN 指南建議增加 G-CSF 的使用,以最大限度地降低癌症患者發生發燒性嗜中性白血球減少症的風險。Onpro 提供了一種獨特的價值主張,尤其是在現在,患者無需返回治療地點即可接受 G-CSF 治療。
Our 2 oncology biosimilars, MVASI and KANJINTI, generated $234 million in sales globally in the first quarter. In the U.S., they sold $108 million and $96 million, respectively, with market shares exiting Q1 at or above 27%. We continue to see encouraging adoption rates in clinics with hospital adoption accelerating. These biosimilars are increasingly valuable given the cost savings that they provide.
我們的兩款腫瘤生物相似藥 MVASI 和 KANJINTI 在第一季全球銷售額達到 2.34 億美元。在美國,它們的銷售額分別為 1.08 億美元和 9,600 萬美元,第一季末的市佔率達到或超過 27%。我們看到診所的採用率持續保持令人鼓舞的水平,醫院的採用率也在加速成長。鑑於生物相似藥能夠節省成本,它們的價值日益凸顯。
Switching to nephrology, starting on Slide 24. Given the serious nature of end-stage renal disease, patients require dialysis treatments 3 days per week. Therefore, we're not seeing a meaningful impact on the use of Amgen medications in these patients that would attribute to COVID-19.
接下來轉到腎臟病學部分,從第 24 張投影片開始。鑑於末期腎病的嚴重性,患者每週需要接受 3 天的透析治療。因此,我們沒有看到 COVID-19 對這些患者使用安進藥物產生了實質影響。
In Q1, EPOGEN sales declined 29% primarily due to lower net selling price from our contractual commitment with DaVita and approximately $20 million of unfavorable changes in accounting estimates.
第一季度,EPOGEN 的銷售額下降了 29%,主要原因是由於我們與 DaVita 的合約承諾導致淨售價降低,以及會計估計中約 2000 萬美元的不利變化。
Sensipar sales declined 42% year-over-year due to the impact of generic competition. As a reminder, supplemental patent protection certificates for cinacalcet have now expired in major EU markets, which could result in a significant decline in ex U.S. sales in 2020.
受仿製藥競爭的影響,Sensipar 的銷售額比去年同期下降了 42%。提醒大家,西那卡塞在歐盟主要市場的補充專利保護證書現已到期,可能導致 2020 年美國以外地區的銷售量大幅下降。
Parsabiv grew by 39% year-over-year in the first quarter. Independent and midsized dialysis providers already utilize Parsabiv for a majority of their calcimimetic patients, while FMC and DaVita continue to increase adoption.
Parsabiv 第一季年增 39%。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。
In summary, I'm truly inspired by the entrepreneurial spirit of our employees who are helping patients and health care providers in this unprecedented time.
總而言之,我深受我們員工的創業精神的鼓舞,他們在這個前所未有的時期幫助了患者和醫療保健提供者。
And with that, I'd like to turn over to Peter.
接下來,我想把麥克風交給彼得。
Peter H. Griffith - Executive VP & CFO
Peter H. Griffith - Executive VP & CFO
Thank you, Murdo. Good afternoon, everyone.
謝謝你,默多。大家下午好。
Before reviewing our results and guidance, I would like to take a moment to build on Bob's comments regarding the unprecedented COVID-19 pandemic and provide additional insights into how we are responding to and navigating through the associated macroeconomic challenges.
在回顧我們的績效和指導意見之前,我想花點時間補充一下鮑伯關於前所未有的 COVID-19 疫情的評論,並進一步闡述我們如何應對和克服相關的宏觀經濟挑戰。
First, we confront these challenges from a position of strength. Our fundamentals are strong. With over $8 billion of cash and investments and a business that generated $2 billion of free cash flow in the first quarter, we are in a strong financial
首先,我們憑藉優勢地位來應對這些挑戰。我們的基本面很強勁。我們擁有超過80億美元的現金和投資,第一季業務產生了20億美元的自由現金流,財務狀況十分穩健。
(technical difficulty)
(技術難題)
We remain committed to our capital allocation principles, shown on Slide 28, which start with investing in internal innovation. We will patiently evaluate external business development opportunities that clear our hurdle rate and are consistent with our areas of therapeutic focus. Our capital expenditures remain a high priority, including our industry-leading, environmentally friendly, next-generation biomanufacturing facility in Rhode Island. We will continue to return capital to our shareholders. Our capital allocation principles will continue to build on our efficient capital structure, which results in an optimal weighted average cost of capital.
我們仍然堅持第 28 頁所示的資本配置原則,也就是從投資內部創新開始。我們將耐心評估符合我們最低收益率要求且與我們的治療重點領域相符的外部業務發展機會。我們的資本支出仍然是重中之重,其中包括我們在羅德島建設的行業領先、環保的下一代生物製造工廠。我們將繼續向股東返還資本。我們的資本配置原則將繼續以高效率的資本結構為基礎,以實現最佳的加權平均資本成本。
Now I will briefly walk through our first quarter financial results before discussing our 2020 guidance. The financial results are shown on Slide 29 of the slide deck. The first quarter marked another period of solid performance as we grew volumes 15%, increased investments in the business and delivered 17% year-over-year non-GAAP EPS growth. Q1 revenues at $6.2 billion increased 11% year-over-year. In the quarter, we saw worldwide product sales increased 12% to $5.9 billion as our portfolio transitioned with strong growth from our newer products outpacing declines in our mature products.
現在我將簡要回顧我們第一季的財務業績,然後再討論我們2020年的業績展望。財務結果顯示在投影片第 29 頁。第一季業績表現依然穩健,銷量成長 15%,業務投資增加,非 GAAP 每股盈餘較去年同期成長 17%。第一季營收達 62 億美元,年增 11%。本季度,隨著新產品強勁成長超過成熟產品的下滑,我們的全球產品銷售額成長了 12%,達到 59 億美元。
Now onto the rest of the P&L. Total operating expense for the quarter increased 7% year-over-year. For the full year, we now expect total operating expenses to grow in the high single-digit percentage range year-over-year on an absolute basis. On a non-GAAP basis, cost of sales as a percent of product sales decreased by 1.6 percentage points to 13.1% driven primarily by lower manufacturing costs, partially offset by an increase in milestone expense. For the full year, we continue to expect cost of sales as a percent of product sales to be generally consistent with 2019.
接下來來看損益表的其餘部分。本季總營運支出較去年同期成長 7%。我們現在預計,全年總營運支出將年增,絕對值將達到較高的個位數百分比。以非GAAP準則計算,銷售成本佔產品銷售額的百分比下降了1.6個百分點,至13.1%,這主要是由於製造成本降低,但部分被里程碑費用增加所抵銷。預計全年銷售成本佔產品銷售額的百分比將與 2019 年基本保持一致。
Research and development expenses of $927 million were 8% higher due to higher spending on Otezla and AMG 510 partially offset by cost recoveries from our collaboration with BeiGene. For the full year, we also expect R&D spend on an absolute basis to increase as we invest in our innovative pipeline and new Otezla indications, with these increases partially offset by R&D recoveries received from our BeiGene collaboration.
研發費用為 9.27 億美元,比去年同期成長 8%,主要原因是 Otezla 和 AMG 510 的研發支出增加,但與百濟神州合作帶來的成本回收部分抵銷了這筆支出。預計全年研發支出絕對值將有所增加,因為我們將投資於創新產品線和 Otezla 的新適應症,但這些增長將被我們從與百濟神州的合作中獲得的研發收益部分抵消。
SG&A expenses increased 12%.
銷售、一般及行政費用增加12%。
(technical difficulty)
(技術難題)
Otezla. And for the full year, we continue to expect SG&A spend to increase primarily due to Otezla spend.
奧特茲拉。全年來看,我們仍預期銷售、一般及行政費用將會增加,主要原因是 Otezla 的支出。
Our Q1 non-GAAP operating income at $3.2 billion increased 15% from prior year. Non-GAAP operating margin was 53.9% for the quarter compared to 52.4% in Q1 of 2019. Other income and expenses were a net $335 million expense in Q1. This is unfavorable by $177 million on a year-over-year basis. This year-over-year change was due to lower interest income on cash balances as well as market fluctuations of publicly traded securities held in our venture portfolio. We anticipate non-GAAP other income and expense to be a net expense toward the upper end of the $1.2 billion to $1.4 billion range we previously provided. Recall that we will begin recording under the equity method of accounting,our share of BeiGene's profit or loss beginning in Q2.
我們第一季的非GAAP營業收入為32億美元,比上年同期成長15%。本季非GAAP營業利益率為53.9%,而2019年第一季為52.4%。第一季其他收入和支出淨額為 3.35 億美元。與上年同期相比,這不利了 1.77 億美元。這一同比變化是由於現金餘額的利息收入減少以及我們風險投資組合中持有的公開交易證券的市場波動造成的。我們預計非GAAP其他收入和支出淨額將接近我們先前提供的12億至14億美元區間的上限。請記住,我們將從第二季開始,並依照權益法核算我們應佔百濟神州的損益。
The non-GAAP tax rate decreased 1.8 percentage points versus Q1 2019 to 12.8%. Non-GAAP net income was [$2.5 billion]
非GAAP稅率較2019年第一季下降1.8個百分點至12.8%。非GAAP淨利為25億美元。
(technical difficulty)
(技術難題)
17% year-over-year for the first quarter, supported by a 5% reduction in share count versus Q1 2019.
第一季同比增長 17%,這得益於與 2019 年第一季相比,股份數量減少了 5%。
Turning next to cash flow and the balance sheet on Slide 30. During Q1 2020, we generated strong cash flow, reflecting a diversified portfolio of products coupled with an industry-leading cost structure. Free cash flow was $2.0 billion in Q1 2020 versus $1.7 billion in Q1 2019. In Q1 2020, we returned a total of $1.9 billion to shareholders through dividend payments totaling over $900 million and over $900 million to repurchase 4.3 million shares at an average price of $219 per share. For the remainder of the year, we plan to maintain our quarterly dividend of $1.60 per share, and we'll execute opportunistic share repurchases that will result in an amount at the lower end of our previous guidance of $3 billion to $5 billion for 2020.
接下來請看第 30 頁的現金流量表和資產負債表。2020 年第一季度,我們實現了強勁的現金流,這得益於我們多元化的產品組合以及業界領先的成本結構。2020 年第一季自由現金流為 20 億美元,而 2019 年第一季為 17 億美元。2020 年第一季度,我們透過支付股息向股東返還了總計 19 億美元,其中超過 9 億美元用於以每股 219 美元的平均價格回購 430 萬股股票。今年剩餘時間裡,我們計劃維持每股 1.60 美元的季度股息,並將進行機會性股票回購,回購金額將處於我們此前 2020 年 30 億至 50 億美元指導範圍的下限。
Cash and investments totaled $8 billion at the end of Q1 2020, a decrease of $18.3 billion from the end of Q1 2019. This decrease was primarily driven by the Otezla and BeiGene transactions, cash returned to shareholders in the form of share repurchases
截至 2020 年第一季末,現金和投資總額為 80 億美元,比 2019 年第一季末減少了 183 億美元。這項降幅主要源自於Otezla和百濟神州的交易,以及以股票回購形式返還給股東的現金。
(technical difficulty)
(技術難題)
as well as net debt repayments partially offset by free cash flow generated during the period. Additionally, I note in Q2 2020, we plan to make $1.75 billion payment in debt payment -- debt maturity payments. We issued $5 billion of long-term debt in February in order to take advantage of market conditions, for refinancing our long-term debt maturities in 2020 and partially those in 2021. We will continue to be opportunistic with strong access to capital markets. Debt outstanding at the end of the quarter totaled $31.8 billion and carries a weighted average interest rate of 3 point
此外,淨債務償還部分被該期間產生的自由現金流所抵銷。此外,我注意到,在 2020 年第二季度,我們計劃支付 17.5 億美元的債務——債務到期付款。為了利用市場條件,我們在 2 月發行了 50 億美元的長期債務,用於為我們 2020 年到期的長期債務以及部分 2021 年到期的長期債務進行再融資。我們將繼續抓住機遇,並充分利用進入資本市場的強大管道。截至季末,未償債務總額為318億美元,加權平均利率為3個百分點。
(technical difficulty)
(技術難題)
years.
年。
Turning to the outlook for the business for 2020, starting on Slide 31. Our guidance provided in January contemplated a broad range of outcomes. Due to the uncertainty related to the COVID-19 impact, we expect some degree of uncertainty in quarterly revenue and earnings over the year. We currently expect that we will see the greatest impact later in Q2, with stabilization and then partial recovery occurring during the second half of the year.
接下來,我們將展望 2020 年的業務前景,從第 31 頁開始。我們在一月份提供的指導意見考慮了各種可能的結果。由於 COVID-19 影響存在不確定性,我們預計全年季度收入和獲利將存在一定程度的不確定性。我們目前預計,第二季後期將出現最大影響,隨後在下半年趨於穩定並出現部分復甦。
And now turning to Slide 32. We are reaffirming our guidance with a revenue range of $25.0 billion to $25.6 billion and a non-GAAP EPS range of $14.85 to $15.60. We will be monitoring the business as the dynamics underlying these assumptions evolve across Q2, and we'll review our latest perspectives with you at our next earnings call. We are now guiding to capital expenditures of $600 million versus our prior guidance of $700 million, reflecting a change in the timing of spend rather than a change to our investment plans. Additionally, we are reaffirming our non-GAAP tax rate guidance of 13.5% to 14.5% for the full year. This concludes the financial update.
現在請看第32張投影片。我們重申先前的業績預期,營收範圍為 250 億美元至 256 億美元,非 GAAP 每股收益範圍為 14.85 美元至 15.60 美元。我們將密切關注第二季業務發展情況,並根據這些假設背後的動態變化,在下次財報電話會議上與您分享我們最新的觀點。我們現在預計資本支出為 6 億美元,而先前的預期為 7 億美元,這反映的是支出時間的變化,而不是投資計畫的變化。此外,我們重申全年非GAAP稅率預期為13.5%至14.5%。財務更新到此結束。
I've been with Amgen a little over 6 months, and it's a privilege to serve patients every day here by supporting and enabling the Amgen difference. And each day during this COVID-19 disruption, I'm reminded that innovation is the miracle drug.
我在安進工作了六個多月,能夠每天在這裡為病人服務,支持和實現安進的獨特優勢,我感到非常榮幸。在新冠疫情帶來的這場混亂中,我每天都深切感受到,創新才是靈丹妙藥。
With that, I'll turn it back over to Bob for some closing remarks.
接下來,我將把發言權交還給鮑勃,請他作總結發言。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Well, before my closing remarks, we'll go to Q&A. So let's -- Ian, let's open it up for Q&A and remind our callers of the process that we'll follow. Thanks.
好的,在我作總結發言之前,我們先進入問答環節。那麼,伊恩,讓我們開始問答環節,並提醒來電者我們將遵循的流程。謝謝。
Operator
Operator
(Operator Instructions) Our first question is from the line of Jay Olson with Oppenheimer.
(操作說明)我們的第一個問題來自 Jay Olson 與 Oppenheimer 的對話。
Jay Olson - Executive Director & Senior Analyst
Jay Olson - Executive Director & Senior Analyst
And thank you for the work that you're doing to fight the COVID-19 pandemic. I wanted to ask about the non-GAAP operating margin. It ticked up nicely in the first quarter. And I noticed that you lowered the OpEx expected growth rate slightly. So I was wondering, how do you expect the operating margin to evolve over the course of 2020? And do you expect that higher operating margin to be sustainable in a post COVID-19 world?
感謝您為對抗新冠肺炎疫情所做的工作。我想諮詢一下非GAAP營業利潤率。第一季表現不錯,穩定上升。我注意到您略微降低了營運支出預期成長率。所以我想知道,您預計2020年營業利潤率會如何改變?您認為在後疫情時代,這種較高的營業利益率能持續嗎?
Peter H. Griffith - Executive VP & CFO
Peter H. Griffith - Executive VP & CFO
Jay, thank you for the question. It's a good question. As I indicated, we do project that for the full year, our total OpEx will grow in the high single-digit percentage range. We are confident in our cost structure and our productivity work here at Amgen. So I think our operating margin speaks for itself, and we expect it to be an industry-leading cost margin going forward in 2020. And of course, we don't give any guidance beyond 2020 on the margins.
傑伊,謝謝你的提問。這是個好問題。正如我之前提到的,我們預計全年營運支出總額將以接近兩位數的百分比增加。我們對安進的成本結構和生產效率充滿信心。所以我認為我們的營業利潤率本身就說明了一切,我們預計到 2020 年,我們的成本利潤率將保持在業界領先地位。當然,對於2020年以後的邊緣問題,我們不提供任何指導。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Just to state the obvious, Jay, we would have liked to have spent more in Q1, but we were getting a little bit disrupted there, as you know, at the end of the quarter. So we'll see what it's like for the remaining 3 quarters of the year.
傑伊,說句顯而易見的話,我們本來希望在第一季投入更多資金,但正如你所知,在季度末我們遇到了一些幹擾。所以,讓我們看看今年剩下的三個季度情況會如何。
Operator
Operator
And our next question is from the line of Tim Anderson with Wolfe Research.
我們的下一個問題來自 Wolfe Research 的 Tim Anderson。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
My question is something that's probably a thorn in your side, which is the ongoing Enbrel patent challenge, and that's one of the bigger events for the company in 2020, the Appeals Court ruling. And I'm sure you're confident in your positioning on how that will play out. But these things are never certain, so I'm wondering if you can just help us describe what plan B would be in the event that Sandoz actually prevails. As your largest product, I'm guessing you had some sort of contingency plan in place. I know it's a low probability event, but any perspective would be helpful.
我的問題可能讓您很頭疼,那就是正在進行的恩利專利挑戰,而上訴法院的裁決是該公司在 2020 年面臨的重大事件之一。我相信你對自己的立場以及事情最終會如何發展也很有信心。但這些事情從來都不是確定的,所以我想請您幫我們描述一下,如果山德士最終勝訴,那麼 B 計劃是什麼。作為你們最大的產品,我猜你們應該制定了某種應急計畫。我知道這是個小機率事件,但任何看法都會有所幫助。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Well, Tim, we're not going to go into details on that. Obviously, we continue to feel confident in the intellectual property around Enbrel, so let's leave it at that for now. Thanks.
提姆,我們就不詳細討論這件事了。顯然,我們對 Enbrel 的智慧財產權仍然充滿信心,所以暫時就到此為止。謝謝。
Operator
Operator
And our next question is from the line of Chris Raymond with Piper Sandler.
下一個問題來自克里斯·雷蒙德和派珀·桑德勒。
Christopher Joseph Raymond - MD & Senior Research Analyst
Christopher Joseph Raymond - MD & Senior Research Analyst
So I know you guys have talked about the collaboration with Adaptive in your antibody program. But just there are a lot of folks, I think, that are working on similar sort of purpose-built products, Regeneron, [Bayer] and others. I wonder if you could give a little bit more color on what differentiates what you guys are doing. And maybe also a little more color on time lines in terms of being in the clinic, et cetera.
我知道你們已經討論過與 Adaptive 在抗體專案上的合作。但我認為,有很多公司都在致力於開發類似的專用產品,例如 Regeneron、[拜耳] 等。我想請您再詳細介紹一下你們的做法有何獨特之處。或許還可以更詳細地描述一下在診所就診的時間軸等等。
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Chris, Dave Reese here. I'll take that question. Yes. So as you know, there are a number of efforts going forward to develop therapeutic antibodies. What we're trying to do, I think, that is potentially unique here is, number one, combine Adaptive's capabilities in immuno profiling with our immunology and particularly our genetics work based out of deCODE. Our goal also is to really identify a very high-quality therapeutic candidate. And it's my belief that there may well be more than one generation of antibody therapeutics entering the clinic, so as we think about this, we want to balance speed of development, which, of course, is important, with generating the highest quality candidate. And as work progresses, we are up and running in the laboratory, but we will provide guidance as -- in terms of clinical time lines as that work unfolds. But that collaboration is actively proceeding right now.
謝謝克里斯,我是戴夫·里斯。我來回答這個問題。是的。如您所知,目前正在進行多項研究,旨在開發治療性抗體。我認為,我們正在嘗試做的,也是可能獨一無二的,是:第一,將 Adaptive 在免疫分析方面的能力與我們基於 deCODE 的免疫學,特別是遺傳學工作相結合。我們的目標也是真正找到一種非常高品質的治療候選藥物。而且我認為,未來可能會有不只一代抗體療法進入臨床階段,因此,在考慮這個問題時,我們希望在研發速度(當然,這很重要)和產生最高品質的候選藥物之間取得平衡。隨著工作的推進,我們在實驗室已經步入正軌,但我們將根據臨床工作的進展情況,提供臨床時間表方面的指導。但目前這項合作正在積極進行中。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Chris, maybe I could just add a comment about manufacturing. Obviously,
克里斯,或許我可以補充一點製造方面的內容。明顯地,
(technical difficulty)
(技術難題)
protein. We have great expertise, manufacturing at scale. And we think one of the things we can bring to the party here is our ability to supply a vast number of patients with our antibody.
蛋白質。我們擁有豐富的專業技術,能夠進行大規模生產。我們認為,我們能為這場疫情帶來的貢獻之一,就是我們有能力為大量患者提供我們的抗體。
Operator
Operator
And our next question is from the line of Geoff Meacham with Bank of America.
下一個問題來自美國銀行的傑夫‧米查姆。
Geoffrey Christopher Meacham - Research Analyst
Geoffrey Christopher Meacham - Research Analyst
I guess one for Bob. When you had the first full quarter of Otezla in the mix, and now it looks like you have a pretty competitive growth profile in the industry from a top and bottom line perspective, so I know that's obviously fully expected, but does either the growth acceleration or the volatility from COVID affect your attitude towards BD? I'm just thinking about maybe a step-up in the number of deals or maybe increasing appetite for larger ones in this environment.
我想這一個是給鮑伯的。當 Otezla 的第一個完整季度業績公佈後,從營收和利潤的角度來看,你們在業界擁有相當有競爭力的成長前景,我知道這顯然是完全可以預期的,但是成長加速或 COVID 帶來的波動是否會影響你們對業務拓展的態度?我只是在考慮,在這種環境下,或許可以增加交易數量,或是提高對大型交易的需求。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
I think the environment is pretty fluid still, Geoff, so I wouldn't try to -- I'm not sure I'd like to declare an answer to your question at the moment but other than to reiterate that -- and we think we're in a strong position. We've talked about our balance sheet, and we talked about our desire to allocate capital to our internal innovation as well as the external innovation. And as you know, we're pretty focused on our strategy, and we'll look to see whether there are things externally that can help us strengthen our chosen areas. But maybe the other thing I would add just as a way to reiterate my appreciation of my Amgen colleagues is we had 3 very significant and successful integrations in the first quarter. So it was a priority for us as a company to get off to a good start with Otezla and with BeiGene and with our Japan transaction. And we really feel we've done that over the first 4 months of the year, so I feel good about that.
傑夫,我認為目前情況仍然相當不穩定,所以我不會嘗試——我不確定現在是否想對你的問題給出答案,但除了重申這一點之外——我們認為我們處於有利地位。我們已經討論過資產負債表,也討論過我們希望將資金分配給內部創新和外部創新。如您所知,我們非常專注於我們的策略,我們會看看外部是否有任何因素可以幫助我們加強我們選擇的領域。但為了再次表達我對安進同事們的感激之情,我還要補充一點:我們在第一季完成了 3 項非常重要且成功的整合。因此,對我們公司而言,首要任務是確保與 Otezla、百濟神州以及我們在日本的交易取得良好的開端。我們感覺在今年前四個月裡確實做到了這一點,所以我對此感到很滿意。
Operator
Operator
And our next question is from the line of Michael Yee with Jefferies.
下一個問題來自 Jefferies 的 Michael Yee。
Michael Jonathan Yee - Equity Analyst
Michael Jonathan Yee - Equity Analyst
Congrats on all the progress and appreciate the color during this tough time. My question was for David. On AMG 510, of course, you didn't mention you have an update at ASCO. Can you just remind us how to think about colorectal cancer as a monotherapy? I guess, what was new there? And then excluding lung and colorectal, there's an update there. Can you just remind us what would be the relevance there? And then the timing on the combos, which is -- which are not at ASCO, what to think about there and timing, appreciate the update.
恭喜你們取得的所有進展,也感謝你們在這段艱難時期帶來的色彩。我的問題要問大衛。當然,關於AMG 510,你沒有提到你在ASCO展會上會有更新。您能否提醒我們一下,如何看待大腸直腸癌作為單一療法?我想,這有什麼新鮮的呢?如果排除肺癌和大腸癌,那方面還有更新。您能提醒我們一下,這其中的關聯是什麼嗎?還有關於組合的時機安排,也就是——哪些組合不在 ASCO 上,需要考慮哪些方面以及時機安排,感謝您的更新。
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Michael. Yes, a series of questions regarding AMG 510. We're continuing to enroll monotherapy patients with colorectal cancer. And as I've indicated before, we're going to look at those data, I would say, over the coming few months to determine whether we feel there's an appropriate monotherapy path forward in colorectal cancer or whether combination therapy is most appropriate. With respect to other non-lung cancer, non-colorectal cancer indications, we will -- we are -- there are other malignancies such as a small percentage of pancreatic cancer, appendiceal cancer, endometrial cancer, and we will be able to provide updates at ASCO on some of those tumors and response data.
謝謝你,麥可。是的,一系列關於AMG 510的問題。我們正在繼續招募接受單一藥物治療的大腸癌患者。正如我之前所指出的,在接下來的幾個月裡,我們將研究這些數據,以確定我們是否認為在結直腸癌治療中存在合適的單藥治療途徑,或者聯合治療是否最為合適。至於其他非肺癌、非結直腸癌適應症,我們將——我們確實——還有其他惡性腫瘤,例如一小部分胰腺癌、闌尾癌、子宮內膜癌,我們將能夠在 ASCO 上提供有關其中一些腫瘤和反應數據的最新資訊。
And then finally, in terms of the combination therapy trial, these are some of the trials that we -- some of them we paused because they were either just initiating or had just initiated. We're getting ready to ramp back up, so I would expect first data, at the earliest, later this year or perhaps the very first part of next year on those. But we're confident that we're not experiencing significant disruptions across the program in totality, and we're happy -- we're quite happy actually with its progress.
最後,關於聯合療法試驗,我們暫停了一些試驗,因為其中一些試驗要么剛開始,要么剛剛啟動。我們正在準備恢復生產,所以我預計最早也要到今年晚些時候,或者明年年初才能獲得相關數據。但我們相信整個專案並未受到重大干擾,我們對專案的進展感到滿意——實際上,我們非常滿意。
Operator
Operator
And our next question is from the line of Terence Flynn with Goldman Sachs.
我們的下一個問題來自高盛的 Terence Flynn。
Terence C. Flynn - MD
Terence C. Flynn - MD
Maybe a follow-up from me on AMG 510. I know you guys have guided to the Phase II lung cancer data in the middle part of this year. Just wondering, now as we're closer to the data, if you could share any perspective on what you view as kind of the efficacy bar here. Is Cyramza the right bar? Or should we think about higher efficacy here given it's a targeted drug?
或許我會就AMG 510做個後續報導。我知道你們已經在今年年中公佈了肺癌二期臨床試驗數據。既然我們現在離數據更近了,我想問您能否分享一下您對這裡所謂的「有效性標準」的看法。Cyramza是合適的酒吧嗎?或者,鑑於這是一種標靶藥物,我們是否應該考慮更高的療效?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Terence. This is Dave. Yes, in terms of the timing of the data, I'd point out that what we've indicated is that we want at least 6 months of response data on all patients. And given that the last patients were enrolled towards the end of the last year, that it takes a month or 2 typically for responses to develop. You can see that, that pushes it into the second half of the year in terms of when we expect the data readout. We're absolutely on track, and we're not experiencing any, I would say, substantial hiccups in the Phase II monotherapy study. We do want robust duration of response and progression-free survival data as part of that package. And I think those endpoints, along with response rate, to address the second part of your question, will be an important part of the package in this Phase II monotherapy study.
謝謝你,特倫斯。這是戴夫。是的,關於數據的時間安排,我想指出,我們已經表明,我們希望獲得所有患者至少 6 個月的療效數據。鑑於最後一批患者是在去年年底入組的,通常需要一到兩個月才能產生療效。你可以看到,這使得我們預計數據公佈的時間推遲到了下半年。我們目前一切進展順利,可以說,在 II 期單藥治療研究中沒有遇到任何實質的困難。我們希望將可靠的緩解持續時間和無惡化存活期數據作為該方案的一部分。我認為,為了回答您問題的第二部分,這些終點指標以及反應率將是這項 II 期單藥治療研究的重要組成部分。
Operator
Operator
And our next question is from the line of Yaron Werber with Cowen.
我們的下一個問題來自 Yaron Werber 與 Cowen 的合作系列。
Yaron Benjamin Werber - MD & Senior Biotechnology Analyst
Yaron Benjamin Werber - MD & Senior Biotechnology Analyst
Great. I have an AMG 510 question as well. The Phase III, David, the study obviously is fairly sizable, it's 650 patients, head-to-head against docetaxel. And I think it kind of drew some questions as to why was that docetaxel really used as the control and not Cyramza in combo. And maybe give us a little bit of sense why is this study so sizable. Is it -- should we read into your expectation on OR? Or is it really about trying to power for survival?
偉大的。我也有一個關於AMG 510的問題。David,這項 III 期研究顯然規模相當大,有 650 名患者,與多西紫杉醇進行直接比較。我認為這引發了一些疑問,為什麼多西他賽被用作對照藥物,而不是在聯合用藥中使用賽拉坦扎。或許還能稍微解釋為什麼這項研究規模如此龐大。我們應該從你的 OR 期望中解讀出什麼嗎?或者,這其實是為了生存而爭取權力?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. Thanks, Yaron, for the question. In terms of the comparator arm, this was -- this choice was based on what remains one of the standards of care, docetaxel, in around the world, the discussions with regulatory authorities and investigators. And we feel that, that's an appropriate comparator here. The sample size calculations were driven by the desire to be able to robustly test for overall survival. And so the second part of your statement there is correct, that this was powered on overall survival.
是的。謝謝亞倫的提問。就對照組而言,這個選擇是基於多西他賽,它仍然是世界各地治療的標準之一,也是與監管機構和研究人員討論的結果。我們認為,這是一個合適的比較對象。樣本量計算的目的是為了能夠可靠地檢驗總體存活率。所以你這句話的第二部分是正確的,即這是基於整體生存率而實現的。
Operator
Operator
And our next question is from the line of Matthew Harrison with Morgan Stanley.
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
Great. I just wanted to ask a question around stocking dynamics for the quarter. I know you've called out a couple of onetime items and what you thought was the benefit from COVID. Could you maybe just put that in context? Obviously, normally, in the first quarter, you see a lot of destocking across the product lines. Did you not see that typical destocking? And so could that be also a potential benefit that's going to come out through the year? Maybe you could just comment on that.
偉大的。我只是想問一下關於本季庫存動態的問題。我知道你提到了一些一次性事件,以及你認為新冠疫情帶來的好處。您能解釋一下上下文嗎?顯然,通常情況下,在第一季度,你會看到各個產品線都出現大量的去庫存。你沒看到那種典型的清倉甩賣嗎?那麼,這會不會也是今年即將出現的潛在好處呢?或許你可以就此發表一下看法。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Matthew, it's Murdo. Yes, as I mentioned, we saw about $100 million of stocking inventory build, I should say, in the first quarter which happened across markets. The only other element that I would maybe compare and contrast to some other companies that are reporting, our business, given that it's predominantly specialty biologics, I know a fair amount of physician administration products didn't necessarily have the same extent of early prescription fills and patient 90-day fills that would have been an additional pull forward for some other companies. As they reported, they blended that dynamic with end customer and wholesale inventory build. So the $100 million refers to end customer and wholesaler inventory specifically. On products like Otezla, we may have had some pull forward from some early fills and maybe 90-day scripts, and we'll just have to wait and see how that works through in Q2.
是的。馬修,我是默多。是的,正如我所提到的,我們在第一季看到了價值約 1 億美元的庫存增加,這種情況發生在各個市場。我唯一想與其他一些正在發布報告的公司進行比較和對比的因素是,鑑於我們的業務主要涉及專業生物製劑,我知道相當一部分醫生用藥產品並沒有像其他一些公司那樣,獲得同樣程度的早期處方配藥和患者 90 天配藥,而這些配藥本可以成為其他一些公司的額外增長動力。據他們報告,他們將這種動態與終端客戶和批發庫存建設相結合。所以這 1 億美元特別指終端客戶和批發商的庫存。對於像 Otezla 這樣的產品,我們可能已經從一些早期配藥和 90 天處方中獲得了一些提前銷售的機會,我們只能拭目以待,看看這在第二季度會如何發展。
Operator
Operator
And our next question is from the line of Robyn Karnauskas with SunTrust Robinson.
我們的下一個問題來自 SunTrust Robinson 的 Robyn Karnauskas。
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
Great work on running the business in this time. So can I take a broader step-back question? I know we've been focused on a lot of specific questions. You guys have had a lot of experience. You've been through this financial crisis and people switching from a commercial payer to a Medicare or government payer. Help us think about how you managed that, how you get people quickly to switch and how you managed the impact of that. And then secondly, for telemedicine, how comfortable are prescribers writing scripts for Evenity? And how do you think that telemedicine really impacts your business? I know that's a new one for you.
在這段時間裡,你們的經營工作做得非常好。那麼,我可以提出一個更宏觀的問題嗎?我知道我們一直專注於許多具體問題。你們經驗很豐富。您已經經歷了這場金融危機,以及人們從商業保險轉而選擇醫療保險或政府保險的情況。請幫助我們思考您是如何做到這一點的,如何讓人們快速轉變,以及您是如何應對由此產生的影響的。其次,對於遠距醫療,處方醫生對使用 Evenity 開處方有多大信心?您認為遠距醫療對您的業務究竟有何影響?我知道這對你來說是個新詞。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Robyn, before Murdo answers, let me make sure we heard that you said how comfortable are we writing or are doctors writing, did you say, Evenity prescriptions on telemedicine?
Robyn,在 Murdo 回答之前,讓我確認一下我們是否聽到了你剛才說的,我們或者醫生在遠距醫療中開處方有多方便,你是說 Evenity 處方嗎?
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
Yes. Yes. Like the telemedicine aspect is new for all of us, so trying to understand how that will impact businesses. And obviously, you have many products that could be prescribed on telemedicine. So those are 2 aspects of
是的。是的。遠距醫療對我們所有人來說都是全新的領域,所以我們正在努力了解它將如何影響企業。顯然,有很多產品可以透過遠距醫療開立處方。所以以上是兩個方面。
(technical difficulty)
(技術難題)
would be great.
那太好了。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Right. Thanks.
正確的。謝謝。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes, Robyn, and if I could just clarify further on the first part of your question, is your question related to opening up government access like we've done over the last little while? Or is it the transition of people potentially from commercial to a government benefit because of COVID-19?
是的,Robyn,如果我能進一步澄清一下你問題的第一部分,你的問題是否與我們最近一段時間以來所做的開放政府訪問權限有關?或者,這是因為新冠疫情導致人們可能從商業救濟過渡到政府救濟嗎?
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
It's really transition. So what a lot of people are asking is what -- if we transition given potentially a lot of people are out of work, they're going to transition to a government-based plan.
這確實是一個過渡時期。所以很多人都在問,如果我們進行過渡,考慮到很多人可能會失業,他們將如何過渡到政府主導的計劃。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes.
是的。
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
You've been through this before. So you're one of the few companies that can probably tell us how you manage that and how you'll run the business and you think the impact might be.
你以前經歷過這種情況。所以,你們可能是少數幾家能夠告訴我們你們是如何管理這些因素、如何經營業務以及你們認為可能產生的影響的公司之一。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Okay. No, that's helpful. Thanks for the clarification. So let's start with that topic on the -- first off, our overall Medicaid portion of our business right now is quite low. It's less than 10% of our total revenue. And the majority of our products beyond that are reimbursed through Medicare Part B and D, with about 50% of our total business being reimbursed through commercial. So it's that commercial piece, as you rightly point out, that is likely -- or a portion of that is likely to transition to a government channel. Now the thing that's harder to predict is at what rate. So as people become unemployed and, an important distinction, is furloughed, they retain benefits for a period of time if they opt into COBRA, and furloughed employees are often still on their self-insured company employee plan, sponsored plan. So there's a time lag that's going to occur before people transition to either a state exchange or a Medicaid benefit. So I think the impact could be a delayed one, more like towards the end of this year and into 2021. And of course, trying to pin down the actual numbers of Americans that are going to end up on unemployment benefits is hard to peg right now. So those are the 2 things. It's the total bolus and the rate of change. I've heard some commentary and read some things that would appear to indicate people expect it earlier. Our perspective is that some of these patients and people will transition over time, and it will more likely be a delay to any effect into 2021.
好的。不,這很有幫助。謝謝你的解釋。那麼,讓我們先從這個主題開始——首先,我們目前業務中 Medicaid 部分的佔比相當低。這不到我們總收入的10%。除此之外,我們的產品大多透過聯邦醫療保險B部分和D部分報銷,約50%的業務透過商業保險報銷。所以,正如你所指出的,商業部分很可能——或者說其中的一部分——會過渡到政府管道。現在更難預測的是速度如何。因此,當人們失業(需要特別注意的是,他們也被暫時解僱)時,如果他們選擇加入 COBRA 計劃,他們可以在一段時間內保留福利;而暫時解僱的員工通常仍然參加他們自保的公司員工計劃或贊助計劃。因此,在人們過渡到州級醫療保險交易平台或醫療補助福利之前,會存在一段時間的延遲。所以我認為這種影響可能會延遲顯現,更可能要等到今年年底甚至 2021 年才會出現。當然,現在很難準確估計最終會有多少美國人領取失業救濟金。以上就是兩件事。指的是總推注劑量和變化率。我聽到了一些評論,也讀到了一些文章,似乎表明人們預計它會更早到來。我們的觀點是,隨著時間的推移,其中一些患者和人群將會逐漸康復,而且任何影響都可能要到 2021 年才會顯現。
On telemedicine, I would just say that there's a variety of maturity of how telemedicine is used by therapeutic area. If you think about mental health and, I would argue, even in neurology, telemedicine is already used quite extensively even pre-COVID. And I would say that the uptake for telemedicine and evaluating someone like a migraine patient is going to be relatively straightforward as it would be perhaps for a dermatology patient. So in the case of neurology migraine would be Aimovig. And then for dermatology, it would be Otezla. You mentioned Evenity. Of course, Evenity is primarily prescribed post fracture, so patients are likely to be in a clinic or a hospital setting, and so the ability for the physician to evaluate the patient and prescribe Evenity is probably pretty straightforward related to that acute event. But we're watching it closely. We -- actually, because of Aimovig and other brands that -- where telemedicine was already being used fairly extensively, we've had some experience here that goes back over a year, and we've been scaling our experience there now. So I think Amgen will be on the front foot when it comes to building out our capabilities in that area.
關於遠距醫療,我想說的是,不同治療領域對遠距醫療的使用成熟度各不相同。如果你考慮心理健康,我認為,即使在神經病學領域,遠距醫療在新冠疫情之前就已經被廣泛使用。我認為,對於偏頭痛患者來說,遠距醫療的普及和評估將會相對容易,就像對皮膚科患者一樣。所以,對於神經系統偏頭痛來說,Aimovig 就是治療偏頭痛的藥物。至於皮膚科,我會選擇 Otezla。你提到了 Evenity。當然,Evenity 主要用於骨折後,因此患者很可能在診所或醫院環境中,因此醫生評估患者並開立 Evenity 處方的能力可能與該急性事件密切相關,相當直接。但我們正在密切關注。實際上,由於 Aimovig 和其他品牌——遠距醫療已經在相當廣泛地使用——我們在這裡積累了一年多的經驗,現在我們正在擴大我們在那裡的經驗。所以我認為,安進在提升該領域的能力方面將處於領先地位。
Operator
Operator
And our next question is from the line of Ronny Gal with Bernstein.
我們的下一個問題來自 Ronny Gal 與 Bernstein 的對話。
Aaron Gal - Senior Research Analyst
Aaron Gal - Senior Research Analyst
Let me add my thanks to and for all the work you're doing on COVID-19. Two, if I may. First, for David, the PD-1, and you expanded on that vertical a couple of times. You started at about 40 patients. Now you have about 270 patients. What -- given that you're originally a little bit skeptical at Amgen about PD-1, is this just looking for ways to leverage the same protocol to do more? And what does that mean about your ability to bring this product to market and timing?
我也要向你們表示感謝,感謝你們在應對新冠肺炎疫情方面所做的一切工作。如果可以的話,我想說兩個。首先,對 David 來說,PD-1,你曾經多次擴展這個垂直領域。最初你們接待了大約 40 位病人。現在您大約有270名患者。鑑於您最初對安進的 PD-1 療法持懷疑態度,這是否只是在尋找利用同一方案實現更多目標的方法?那麼這對你將這款產品推向市場的能力和時機又意味著什麼?
And then to Murdo, you've done fabulously well with about (inaudible), you did about $320 million this quarter. Now you have [5] that's coming in, in the United States. They've taken a bit more extra price decreases. What is that -- what's your expectation for the rest of the year? And if you can also mention what you guys are doing with your Remicade biosimilar, kind of an interesting product.
然後,默多,你做得非常出色,大約(聽不清楚),你這季度賺了大約 3.2 億美元。現在,美國有[5]即將到來。他們又進行了一次額外的降價。那是什麼? ——你對今年剩下的時間有什麼期望?如果你還能介紹一下你們在 Remicade 生物相似藥方面的工作,那將會是一個很有趣的產品。
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Well, thanks, Ronny. This is Dave. I'll start with the PD-1 question for AMG 404. We continue to develop AMG 404 primarily as a combination partner for our pipeline agents. This is a Phase I umbrella study, and we added cohorts to study additional indications where the tumors in question have well-described PD-1 sensitivity that will limit the need, we hope, for single-arm data in future trials. And ultimately, we think we'll probably need on the order of 200, give or take, monotherapy patients to support the standard safety package for AMG 404. So all of that put together, expansion of the Phase I trial allowed us an efficient way to generate appropriate data.
謝謝你,羅尼。這是戴夫。我先回答關於 AMG 404 的 PD-1 問題。我們繼續開發 AMG 404,主要將其作為我們管道代理商的組合合作夥伴。這是一項 I 期傘式研究,我們增加了隊列研究,以研究其他適應症,這些適應症涉及的腫瘤具有明確的 PD-1 敏感性,我們希望這將減少未來試驗中對單臂數據的需求。最終,我們認為可能需要大約 200 名單藥治療患者來支持 AMG 404 的標準安全方案。綜上所述,I 期試驗的擴展使我們能夠有效地產生適當的數據。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. And when it comes to our biosimilars business, we are pleased with the run rate of over $300 million in the quarter. I would say, I would attribute our success, first and foremost, to Amgen's reputation as a high-quality biologics manufacturer. I think that is something that differentiates us and is perceived well by our customers. Our experience in Europe was a very positive one. We applied those lessons learned to our U.S. launches of the 2 oncology biosimilars. And I think it shows you that the biosimilars market is functioning well in the United States. I would also say that the biosimilar business model for Amgen is very much integrated with our innovative products. So the same people who are defending Neulasta, the same account managers who are defending Neulasta day in, day out and making sure that the benefit of Onpro is understood by our customers are the same people who are establishing the uptake curve for MVASI and KANJINTI. So those account relationships that we've cultivated over many, many years in oncology have been extremely valuable. And our relationships at the payer-provider level, I think, have helped us extend that trajectory nicely. I would also say that our patient services are exemplary, and we have the very same patient services that we have for a product like KYPROLIS or XGEVA we apply to our biosimilars business as well.
是的。至於我們的生物相似藥業務,我們對本季超過 3 億美元的營收速度感到滿意。我認為,我們的成功首先要歸功於安進作為高品質生物製劑生產商的聲譽。我認為這是我們的優勢所在,也受到了客戶的好評。我們在歐洲的體驗非常愉快。我們將這些經驗教訓應用到我們在美國推出的兩款腫瘤生物相似藥中。我認為這表明,美國的生物相似藥市場運作良好。我還要說,安進的生物相似藥商業模式與我們的創新產品高度融合。因此,那些為 Neulasta 辯護的人,那些日復一日為 Neulasta 辯護並確保我們的客戶了解 Onpro 的好處的客戶經理,也是那些正在建立 MVASI 和 KANJINTI 的採用曲線的人。因此,我們在腫瘤領域多年來建立的客戶關係非常有價值。我認為,我們在支付方和提供方層面的關係,幫助我們很好地延續了這個發展軌跡。我還要說,我們的病患服務堪稱典範,我們對 KYPROLIS 或 XGEVA 等產品提供的病患服務,同樣也應用於我們的生物相似藥業務。
And then you mentioned, I think, AVSOLA, which is our Remicade biosimilar. We do intend to launch that this year. And that product will help strengthen what is already a strong immunotherapy portfolio for us and will help us broaden out that customer perspective. And again, that product will be integrated with our innovative autoimmune portfolio.
然後您提到了 AVSOLA,我想,這是我們的 Remicade 生物相似藥。我們計劃今年推出該產品。該產品將有助於加強我們現有的強大的免疫療法產品組合,並有助於我們拓寬客戶視野。此外,該產品將與我們創新的自身免疫產品組合相結合。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Ian, let's take the next question. And it's getting -- and as it's getting late on the East Coast, (Operator Instructions). Ian, let's go on with the next one.
伊恩,我們來看下一個問題。東海岸時間已經很晚了,(操作說明)。伊恩,我們繼續下一個。
Operator
Operator
Our next one is from the line of Evan Seigerman with Crédit Suisse.
接下來要介紹的是 Evan Seigerman 與瑞士信貸合作推出的產品系列。
Evan David Seigerman - VP & Senior Equity Research Analyst
Evan David Seigerman - VP & Senior Equity Research Analyst
Kind of a follow-up from what you were just talking about, Murdo, so how has the pandemic impacted the uptick of biosimilars? Have you seen an acceleration in adoption to save cost? Or have centers really delayed uptake given potentially overwhelmed systems?
Murdo,這算是你剛才談話的一個後續,那麼疫情對生物相似藥的增長產生了怎樣的影響呢?您是否注意到為了節省成本而加速採用新方法的情況?或者,是否因為系統可能不堪重負而導致各中心確實推遲了接收?
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
So it's a bit early to tell, so take my comments with a very few weeks of experience here. I would say, so far, we have not seen a negative effect on our uptake. If anything, we're seeing a steepening of our uptake curve. The one thing I will say that we haven't yet assessed that could happen is the total cycles of bevacizumab or the total cycles of trastuzumab could be impacted. So from a share of molecule perspective, we're very pleased. What we're watching is the total number of infusions of each of the molecules going forward.
現在下結論還為時過早,所以我的評論僅基於我在這裡短短幾週的經驗。我認為,到目前為止,我們還沒有看到對我們的吸收率產生負面影響。如果有什麼變化的話,那就是我們的用戶成長曲線變得更加陡峭了。我要說的一件事是,我們尚未評估可能會發生的事情,那就是貝伐珠單抗的總療程或曲妥珠單抗的總療程可能會受到影響。所以從分子份額的角度來看,我們非常滿意。我們正在觀察的是未來每種分子輸注的總次數。
Operator
Operator
And our next question is from the line of Dane Leone with Raymond James.
我們的下一個問題來自 Dane Leone 與 Raymond James 的對話。
Dane Vincent Leone - Research Analyst
Dane Vincent Leone - Research Analyst
I just want to ask a business development question, and I'll just keep it to one here. When you're thinking about ramping up your efforts of KRAS, obviously, the initial data set is great for how you're thinking about the target oncology space. Thinking about that and then also thinking about the bolt-on with Otezla that you did to start broadening out how you think about immunology, where do you want to go in those respective areas from a biz dev perspective? I mean there's a lot of room you guys still have to work with especially in target oncology. Should we be expecting more bolt-on acquisitions within these 2 areas over the course of 2020?
我只想問一個關於業務拓展的問題,而且我只問一個。當您考慮加強對 KRAS 的研究力度時,顯然,初始資料集對於您如何思考目標腫瘤學領域非常有幫助。考慮到這一點,以及你與 Otezla 合作拓展免疫學思維方式的舉措,從業務拓展的角度來看,你希望在這些領域朝著哪個方向發展?我的意思是,你們還有很多工作要做,尤其是在標靶腫瘤學領域。我們是否應該預期 2020 年這兩個領域會有更多併購交易?
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
I don't know about the course of 2020, Dane. We're -- those are 2 areas of keen interest for us for sure, oncology and inflammation. And we will continue to look for attractive, innovative assets that we think we can add value to. The trick is always to be able to license or acquire molecules at a price that leaves return for our shareholders. And we're pretty comprehensive in the way we assess the marketplace, and we'll continue to keep an active watch and see whether there are some things that might be a good fit.
丹恩,我不知道2020年的發展會如何。腫瘤學和發炎絕對是我們非常感興趣的兩個領域。我們將繼續尋找我們認為可以增值的、具有吸引力的、具有創新性的資產。關鍵在於能夠以合理的價格獲得分子許可或收購,為股東帶來回報。我們在評估市場方面採取了相當全面的方法,我們將繼續積極關注,看看是否有一些合適的機會。
Operator
Operator
And our next question is from the line of Umer Raffat with Evercore ISI. Umer, you may have us on mute.
我們的下一個問題來自 Evercore ISI 的 Umer Raffat。烏默,你可能把我們靜音了。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Let's come back to him.
我們再來說說他。
Operator
Operator
And moving on to the next question, it's from Alethia Young with Cantor Fitzgerald.
接下來是來自 Cantor Fitzgerald 的 Alethia Young 的問題。
Alethia Rene Young - Head of Healthcare Research
Alethia Rene Young - Head of Healthcare Research
I guess I just wanted to know, when you think about the Otezla and some of the benefit you're seeing with the orals, maybe in light of COVID, do you think that might be a sustainable trend?
我想知道的是,考慮到 Otezla 以及口服藥物的一些益處,尤其是在新冠疫情的影響下,您認為這會是一種可持續的趨勢嗎?
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Alethia, I just want to clarify -- it's Murdo here. You're talking about the natural demand, you're not talking about clinical trial activity with Otezla, correct?
是的。Alethia,我只是想澄清一下——這裡是 Murdo。您指的是自然需求,而不是 Otezla 的臨床試驗活動,對嗎?
Alethia Rene Young - Head of Healthcare Research
Alethia Rene Young - Head of Healthcare Research
No, not clinical trial, commercial activity, please.
不,不是臨床試驗,而是商業活動。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Okay. Yes, we're -- look, we continue to watch the weekly trends. We're listening to what our customers are telling us. And we definitely think that we've got a little bit of buffer supporting Otezla right now because it is a convenient oral option. It's got great market access coverage. It's affordable. We're -- obviously, also, we mentioned at the end of last year that we were putting in additional primary care effort to broaden the promotional effort behind Otezla, and I think that's also helping. So we're feeling good about it. And I think just it's the ideal kind of product for a time like this where a lot of patients are concerned about visiting a health care professional.
是的。好的。是的,我們——你看,我們會繼續關注每週的趨勢。我們正在傾聽客戶的回饋。我們絕對認為,目前 Otezla 有一定的市場緩衝空間,因為它是一種方便的口服藥物。它擁有極佳的市場准入覆蓋率。價格實惠。顯然,我們在去年年底也提到,我們正在加大對初級保健的投入,以擴大 Otezla 的推廣力度,我認為這也有幫助。所以我們對此感覺很好。我認為這正適合像現在這樣的時期,因為許多患者都擔心去看醫療保健專業人員。
Operator
Operator
And our next question is from the line of Geoffrey Porges with SVB Leerink.
下一個問題來自 SVB Leerink 的 Geoffrey Porges。
Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst
Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst
A follow-up, Murdo, another question. You highlighted some of the softness that you were seeing in March and then continuing into April for some of the office-administered injectables. Could you give us a sense of which products you think are most likely to be most significantly affected? I think you particularly highlighted the Prolia visits that might be down as much as 50% of those relevant specialties. Is that the sort of effect that we should be expecting for Prolia in Q2?
默多,還有一個後續問題。您特別提到了三月以及四月一些診所注射的藥物所表現出的皮膚柔軟度下降的情況。您能否大致說明一下您認為哪些產品最有可能受到最顯著的影響?我認為你特別強調了 Prolia 的就診量,相關專科的就診量可能下降了 50%。這是我們應該預期 Prolia 在第二季所取得的效果嗎?
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. I think -- thank you, Geoff. I think what I mentioned was the patient visits were down 50%. So Prolia and -- we're maybe not as impacted yet on Evenity, are definitely the products that we're seeing most impact in our portfolio. If you think about the physician-administered products for Amgen in 3 buckets, we have our bone business, we have our nephrology business, and we have our oncology business. Bone is by far the business that is being impacted the most. Obviously, it's partly to do with the age and vulnerability of patients. And we're spending a lot of time working on alternate sites of care, improving continuity of care, setting up mobile programs where nurses can visit patients' homes and administer. And we're working -- continue to work with the administration, CMS, policy, advocates to try and improve the buy-and-bill access to that home injection channel as well. Nephrology is holding up well. Obviously, in end-stage renal disease, these patients have to have -- their dialysis is life sustaining. So those volumes are holding up well. The providers there have been very good at collaborating and providing safe, isolated sites of care for patients. And then oncology, it's down but not nearly as much as the bone. So that gives you a relative order of understanding of how we're seeing it.
是的。我想——謝謝你,傑夫。我想我之前提到的是,患者就診量下降了 50%。所以,Prolia 和 Evenity(雖然可能還沒有受到太大影響)絕對是我們產品組合中受影響最大的產品。如果把安進公司的醫生管理產品分為三類,那就是我們的骨骼業務、腎臟業務和腫瘤業務。骨科是受影響最大的行業。顯然,這部分與患者的年齡和體質有關。我們正在投入大量時間研究替代護理場所,改善護理的連續性,建立移動項目,讓護理人員可以到病人家中進行護理。我們正在努力——繼續與政府、CMS、政策制定者和倡導者合作,努力改善透過「購買和結算」方式獲得家庭注射服務的途徑。腎臟病學目前狀況良好。顯然,對於末期腎臟病患者來說,透析是維持生命的必要手段。所以這些交易量保持良好。那裡的醫護人員在合作方面做得非常好,為病人提供了一個安全、獨立的照護場所。腫瘤科的病例數也有所下降,但遠不及骨科的病例數下降那麼多。這樣就能讓你對我們看待這個問題的方式有一個相對的理解順序。
Operator
Operator
And our next question is from the line of Cory Kasimov with JPMorgan.
下一個問題來自摩根大通的科里·卡西莫夫。
Cory William Kasimov - Senior Biotechnology Analyst
Cory William Kasimov - Senior Biotechnology Analyst
Great. Given the importance of this growth portfolio to the overall business, I wanted to better understand the underlying dynamics for Aimovig. When we look at it, I mean, despite the leading share position and an increase in paid prescriptions, sales have seemingly fallen short of expectations for the last few quarters. Is this just a function of lower net price with the broader access? Or is there something else going on that we're all missing?
偉大的。鑑於該成長組合對整體業務的重要性,我想更深入了解 Aimovig 的潛在動態。我的意思是,從我們的角度來看,儘管市場份額領先,付費處方數量也有所增加,但近幾個季度的銷售額似乎都低於預期。這只是因為更廣泛的管道帶來了更低的淨價嗎?或者,是不是還有其他我們都沒注意到的事情?
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Thanks, Cory. Look, we're very pleased with Aimovig's share performance. And we did have to do quite a bit of work over the course of the year to get to that 90% paid level. And now we have 93% of covered lives. So we're pretty pleased about that basis. I think what we're counting on for growth going forward, because we expect price to stabilize throughout the course of the balance of the year, is we're coming on unlocking additional patient volume. We've got over 4 million potential CGRP patient candidates out there. Physicians tend to persist with older oral products and aren't yet adopting CGRP products at the rate that we think that they could and should be to help ease the suffering of chronic migraine sufferers. So that's where we're focused. We're focused on unlocking the future potential volume now that these products and particularly Aimovig has a very affordable access coverage in the market.
是的。謝謝你,科里。你看,我們對Aimovig的股價表現非常滿意。為了達到 90% 的帶薪水平,我們確實在這一年中做了很多工作。現在我們已經覆蓋了93%的人口。所以我們對這個基礎相當滿意。我認為,我們未來成長的動力在於,我們預計價格將在今年剩餘時間內趨於穩定,而我們即將迎來更多患者。我們有超過 400 萬潛在的 CGRP 患者候選者。醫生們往往堅持使用較老的口服產品,還沒有以我們認為他們能夠而且應該採取的速度採用 CGRP 產品,以幫助減輕慢性偏頭痛患者的痛苦。所以這就是我們關注的重點。我們現在專注於釋放未來的潛在銷量,因為這些產品,特別是 Aimovig,在市場上擁有非常實惠的覆蓋範圍。
Operator
Operator
And it appears that we have Umer Raffat from Evercore ISI back on.
看來 Evercore ISI 的 Umer Raffat 又回來了。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
I just learned how to unmute myself, so thank you so much. David, one question for you, if I may. I think it will be very helpful for investors to understand if you're optimistic on the durability of response with KRAS monotherapy and if you're starting to develop a view whether a MEK or a PD-1 is a better combination partner.
我剛學會怎麼解除靜音,非常感謝。大衛,我可以問你一個問題嗎?我認為,了解你是否對 KRAS 單藥療法的療效持久性持樂觀態度,以及你是否開始考慮 MEK 或 PD-1 是更好的聯合治療夥伴,對投資者來說將非常有幫助。
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Umer, for the question. Yes. I mean I think duration of response is one of the critical questions, and that's why I indicated that the Phase II trial, I think, is going to give us the definitive answer there. That will -- and we wish to have enough follow-up to very robustly address both duration of response and progression-free survival. In terms of the combinations, I think it's perhaps a little too early to pick favorites. We are looking at a number of combinations, which is typical for oncology programs. All of those are based on an underlying biologic rationale. And as I indicated, we'll be generating data in that program in combinations over the course of this year.
謝謝 Umer 的提問。是的。我的意思是,我認為療效持續時間是關鍵問題之一,所以我才說,我認為二期試驗將為我們帶來最終答案。這將會-我們希望有足夠的後續研究來非常有力地評估緩解持續時間和無惡化存活期。至於各種組合,我覺得現在選出最喜歡的組合可能還太早。我們正在研究多種組合方案,這在腫瘤治療計畫中很常見。所有這些都基於基本的生物學原理。正如我之前提到的,我們將在今年透過該程式產生各種組合數據。
Operator
Operator
And next, we have a question from the line of Michael Schmidt with Guggenheim.
接下來,我們來聽聽邁克爾·施密特(Michael Schmidt)和古根漢(Guggenheim)提出的問題。
Michael Werner Schmidt - Senior Analyst & Senior MD
Michael Werner Schmidt - Senior Analyst & Senior MD
I had a high-level question on the biosimilar business, which has been going really well for Amgen. I'm just wondering, as we see sort of the biosimilar market mature longer term and as we see potentially more products launch within these markets, I guess, what is your view on the long-term price erosion relative to brand? And how should we think about a potential floor relative to the manufacturing and development costs in the biosimilar area?
我有一個關於生物相似藥業務的高層次問題,安進的這項業務發展得非常好。我只是想知道,隨著生物相似藥市場逐漸成熟,以及這些市場中可能會有更多產品上市,您如何看待生物相似藥相對於品牌藥的長期價格侵蝕?那麼,我們該如何看待生物相似藥領域相對於生產和研發成本的潛在最低限度呢?
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Thanks, Michael. The one thing I mentioned earlier in response to the question on biosimilars was the Amgen experience in knowing how to make biologics at scale in a very efficient way. So we have really good margins on this business. And I think going by our experience in Europe, where I would argue that the price degradation has probably been faster than it will be in the U.S. even with multiple competitors, we've been able to compete effectively for volume, and we've been able to retain a very profitable business there. We obviously don't have a lot of analogs in the U.S. to understand the rate of change, so I'm going to hold back from speculating on what the future will hold. But there are clear things here that the more competitors you have compressed in the early phase of a biosimilar launch path and the more likely there is to be some precipitous price erosion. We're fortunate that we were early in the U.S. with both MVASI and KANJINTI and able to establish a very strong foothold in the market. I'll also repeat it, I said it earlier, but I do think that the biosimilar market is alive and well in the U.S. and functioning as you would hope free markets would.
是的。謝謝你,麥可。我之前在回答有關生物相似藥的問題時提到的一點是,安進公司在大規模高效生產生物製劑方面擁有豐富的經驗。所以我們這項業務的利潤率真的很高。我認為,根據我們在歐洲的經驗,即使在美國有多個競爭對手,價格下降的速度也可能比美國更快,但我們仍然能夠有效地爭奪銷量,並在那裡保持了非常盈利的業務。顯然,美國沒有太多類似的例子來理解這種變化的速度,所以我不會對未來做出猜測。但有一點很明確:在生物相似藥上市初期,競爭對手越多,價格就越有可能急劇下降。我們很幸運,MVASI 和 KANJINTI 這兩個品牌很早就進入了美國市場,並且得以在市場上站穩腳跟。我還要再說一遍,我之前說過,我認為美國的生物相似藥市場充滿活力,運作良好,正如你所希望的那樣,自由市場正在發揮作用。
Operator
Operator
And our next question is from the line of Carter Gould with Barclays.
下一個問題來自巴克萊銀行的卡特·古爾德。
Carter Lewis Gould - Senior Analyst
Carter Lewis Gould - Senior Analyst
I guess maybe just a bigger picture question around sort of the lasting impact of COVID. When you guys think around either shift to manufacturing strategy, location, bigger picture questions on footprint and, I guess, as well as commercialization models, I guess, it's just a really kind of a bigger picture question, when we return to normal, would that look different to sort of your infrastructure and business model is how you had set it up historically?
我想,這或許應該從更宏觀的角度來看新冠疫情的長期影響。當你們考慮轉向生產策略、選址、更大的佈局問題以及商業化模式時,我想,這確實是一個更宏觀的問題:當我們恢復正常時,你們的基礎設施和商業模式是否會與你們過去建立的有所不同?
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Yes. That's a really interesting question, Carter, and one that I think we'll get a lot of attention once things have settled down a little bit. It's still awfully fluid to be trying to predict how the experience of COVID-19 will affect our industry or our business model. But we'd be happy to engage with you on that topic at greater length, again, when the dust has settled a little bit.
是的。卡特,這真是一個很有趣的問題,我想等事情稍微平靜下來之後,這個問題會得到很多關注。預測 COVID-19 疫情將如何影響我們的產業或商業模式,目前情況仍然非常不穩定。但等塵埃落定之後,我們很樂意再次與您就此主題進行更深入的探討。
But fundamentally for us, our supply chain is in great shape. We, unlike some of our peers in the industry, predominantly manufacturer in the U.S., obviously
但從根本上來說,我們的供應鏈狀況良好。與業內一些同行不同,我們主要在美國生產,這顯而易見。
(technical difficulty)
(技術難題)
the people who work for us there are U.S. citizens. And so we have the benefit that the vast majority, nearly all of our manufacturing is done in the U.S. So that supply chain question is a little bit less relevant for us than some of our industry peers. But I do think that this isn't going to be the last viral challenge that we face as a society. And I think we'll all be trying to improve our business continuity planning and thinking when we come out of this to make sure that we're in as strong a position as possible to avoid interruptions from events like this. But I think there'll be a lot of learning across the whole economy, including the biotech economy. So we look forward to talking to you about that at the right time.
在那裡為我們工作的人都是美國公民。因此,我們的優勢在於,我們絕大部分、幾乎全部的生產都在美國完成。所以,供應鏈問題對我們來說,不像對我們的一些同行那麼重要。但我認為這不會是我們社會面臨的最後一個病毒挑戰。我認為,當我們走出這場危機後,我們都會努力改善業務連續性計畫和思路,以確保我們能夠盡可能地處於有利地位,避免此類事件造成的業務中斷。但我認為整個經濟領域,包括生技經濟領域,都會有很多學習的機會。所以,我們期待在合適的時機與您討論這個問題。
Operator
Operator
And next, we have a question from the line of Mohit Bansal with Citi.
接下來,我們來聽聽花旗銀行的 Mohit Bansal 提出的問題。
Mohit Bansal - VP and Analyst
Mohit Bansal - VP and Analyst
Congrats on all the progress. I have a quick question regarding your IL-2 mutein program. What is your level of excitement around this program? Seems like you have 2 fully enrolled trials at this point. Should we expect to see any data from this program later this year?
祝賀你們取得的所有進展。我有一個關於你們的IL-2突變體計劃的小問題。你對這個項目有多期待?目前看來,你們已經有 2 個試驗項目完成了全部受試者招募。我們是否可以預期今年稍後會看到該項目的任何數據?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Mohit. Dave here. Yes, so we remain keenly interested in AMG 592, the IL-2 mutein. We're enrolling trials going forward, and we'd expect data over the course of the year or perhaps early next year. Some of those trials we did temporarily pause because of the reluctance of investigators to start patients on new immunomodulatory agents in the course of the epidemic. But we remain quite interested in that program, and we'll provide our guidance as to when we're going to get data readouts as we move forward.
謝謝,莫希特。我是戴夫。是的,所以我們仍然對 IL-2 突變體 AMG 592 非常感興趣。我們將繼續進行試驗,預計今年內或明年年初將獲得數據。由於研究人員不願在疫情期間讓患者使用新的免疫調節劑,我們的一些試驗暫時中止了。但我們仍然對該專案非常感興趣,我們將在推進過程中提供關於何時獲得數據讀數的指導。
Operator
Operator
And next, we have a question from the line of Kennen MacKay with RBC Capital Markets.
接下來,我們來聽聽來自加拿大皇家銀行資本市場的 Kennen MacKay 的問題。
Kennen B. MacKay - MD & Co-Head of US Biotechnology Research
Kennen B. MacKay - MD & Co-Head of US Biotechnology Research
Maybe for Peter or Bob or -- actually, I'd even love to hear Dr. Reese's perspective. I was wondering where are you seeing the most opportunity for M&A right now and really where your focus there. And Dave, I had hoped to include you in that question really just to get your perspective on where some of the most interesting biology and chemistry is taking place now and what Bob had referred to so eloquently as the golden age of biotechnology.
或許彼得或鮑伯會這麼想——實際上,我甚至很想聽聽里斯博士的看法。我想知道您認為目前併購領域最大的機會在哪裡,以及您在這方面的關注重點是什麼。戴夫,我原本希望你能參與這個問題中來,其實只是想聽聽你對目前一些最有趣的生物學和化學研究領域的看法,以及鮑勃雄辯地稱之為生物技術黃金時代的研究。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Well, Dave, since I've talked a little bit about M&A and business development already on the call, why don't we let you take a crack at this? So what areas -- what mechanisms are most intriguing to you in your R&D colleagues at the moment?
戴夫,既然我在電話會議上已經談到了一些併購和業務發展方面的話題,不如讓我們讓你來嘗試一下吧?那麼,目前您認為研發同事中最感興趣的領域或機制是什麼?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes, I think it is a golden age, and I would approach it from 2 perspectives. There are new platforms. And our Head of Research, Ray Deshaies, has published a very -- a great article in Nature a week or 2 ago. I'd encourage all of you to read about what we call an induced proximity platform. This is a new suite of technologies that we think can open up much of the undruggable space. So that sort of business development remains of great interest to us. And then as we've said before, I think there's a ferment of activity across the therapeutic areas of great interest to us, and that will continue to be a focus going forward.
是的,我認為這是一個黃金時代,我會從兩個方面來看待它。出現了新的平台。我們的研究主管雷·德沙耶斯(Ray Deshaies)在一兩週前在《自然》雜誌上發表了一篇非常精彩的文章。我建議大家了解我們所說的誘導接近平台。這是一套我們認為可以開拓許多無法用藥物治療的領域的新技術。因此,這類業務發展仍是我們非常感興趣的領域。正如我們之前所說,我認為在我們非常感興趣的治療領域,各種活動都在蓬勃發展,這將繼續是我們未來的重點。
Operator
Operator
And next, we have a question from the line of Salim Syed with Mizuho.
接下來,我們來聽聽瑞穗銀行的 Salim Syed 提出的問題。
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
Bob, maybe just one for you, just a high-level one. Given your discussions with folks in Washington, obviously, the rhetoric in biotech and pharma as well has been pretty negative over the last few years especially around drug pricing, et cetera. And I'm wondering with -- given this COVID-19, has that changed the rhetoric at all in your view? And is there anything sustainably positive that can carry on post-COVID in terms of rhetoric coming out of Washington in your view?
鮑勃,或許就給你一個,一個高水準的。鑑於你與華盛頓人士的討論,顯然,過去幾年生物技術和製藥業的言論也相當負面,尤其是在藥品定價等方面。我想知道,鑑於新冠疫情,您認為這是否改變了人們的言論?在你看來,後疫情時代,華盛頓方面還有哪些積極言論能夠持續下去?
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Well, I think everybody recognizes that we're going to need science and innovation to lead us out of this challenge that we find ourselves in globally. So
我認為大家都體認到,我們需要科學和創新來帶領我們走出目前全球面臨的挑戰。所以
(technical difficulty)
(技術難題)
importance of innovation, a little bit of humility perhaps in all camps about how hard it is to have the right innovation available for the world at the right time. So the good news is that the government, the innovators, academia, everybody are working together at a speed and a scale that I've never seen in my career. So I think that's a good sign, and hopefully, we'd be able to look back on this one day and say that it worked. We've got a special ecosystem, in particular, in this country. And hopefully, we'll be able to look back and say, when we faced the biggest challenge of our lifetimes, the industry came through and delivered what we needed. And if we're able to do that, I think it inevitably will help remind everybody that we haven't generated all the innovation we need as a society. There are still lots of areas of unmet medical need. And again, the more we can do to address it the better. But the question of drug pricing is not going to go away, but hopefully, there'll be some respect for how profoundly important innovation is.
創新至關重要,但各方或許都應該謙虛一點,認識到在正確的時間為世界提供正確的創新是多麼困難。好消息是,政府、創新者、學術界,所有人都在以我職業生涯中從未見過的速度和規模共同努力。所以我認為這是一個好兆頭,希望有一天我們能夠回顧這一切,並說它奏效了。我們國家擁有一個特殊的生態系統。希望將來我們能夠回顧往事,並說,當我們面臨一生中最大的挑戰時,這個行業挺身而出,提供了我們所需的一切。如果我們能夠做到這一點,我認為這必然會提醒所有人,我們作為一個社會,還沒有產生我們所需要的所有創新。目前仍有許多醫療需求尚未被滿足。再次強調,我們能做的越多,就越能解決這個問題。但藥品定價問題不會消失,但希望人們能尊重創新的深遠重要性。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
And let's take one last question if there's a quick one, after which I'll ask Bob to make some concluding comments.
如果還有人能快速回答最後一個問題,我們就問最後一個。之後,我會請鮑伯做一些總結性發言。
Operator
Operator
Very well. Our final question is from the line of Jim Birchenough with Wells Fargo Securities.
很好。最後一個問題來自富國證券的吉姆·伯奇諾夫。
Nicholas M. Abbott - Director & Associate Analyst
Nicholas M. Abbott - Director & Associate Analyst
It's Nick on for Jim. You had mentioned earlier in your prepared comments about Otezla, the trial of Otezla in COVID. Can you just elaborate on that? And is this in the acute setting? Or perhaps is there an opportunity for patients who have ongoing organ dysfunction after they leave the hospital maybe due to inflammation?
尼克代替吉姆上場。您之前在準備好的評論中提到了 Otezla,以及 Otezla 在 COVID 中的試驗。能詳細解釋一下嗎?這是在急性情況下嗎?或者,對於出院後因發炎等原因持續存在器官功能障礙的患者來說,這是否是一個機會?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Thanks, Jim (sic) [Nick]. This is Dave. Yes, we think it's actually -- there will be utility in studying Otezla in a variety of settings, ranging from, for example, hospitalized patients but those that are not yet in the ICU to attempt to prevent progression to more serious disease as well as those with more serious disease. And so again, we're in active discussions or have committed to platform trials. The one real guiding principle we have here is that we want these to be rigorous studies to provide the highest quality answers.
謝謝,吉姆(原文如此)[尼克]。這是戴夫。是的,我們認為在各種環境下研究 Otezla 確實會很有幫助,例如,可以研究住院患者(包括尚未進入 ICU 的患者)的治療效果,以嘗試阻止病情惡化,以及研究病情更嚴重的患者。因此,我們正在積極討論或已經致力於平台試驗。我們在這裡秉持的唯一真正指導原則是,我們希望這些研究嚴謹細緻,以提供最高品質的答案。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Okay. Let me just wrap up, recognizing that it's pushing on 7:00 on the East Coast. Again, let me reiterate our appreciation for you joining the call. I hope what you take away from the call is that we delivered a solid quarter 1. We feel we're executing the business well. Our objective will be to remain an effective steward of the business through the short term. We want to be a leading corporate citizen through this challenging period as well. And we will remain focused on delivering long-term growth by advancing innovation in those areas that you're familiar with at Amgen.
好的。讓我總結一下,我知道現在美國東部時間已經快7點了。再次感謝您參加此次電話會議。我希望大家從這次電話會議中了解到,我們第一季的業績表現穩健。我們認為我們的業務執行得很好。我們的目標是在短期內繼續有效管理公司業務。我們希望在這個充滿挑戰的時期,也能成為具有擔當的企業公民。我們將繼續專注於在安進公司您所熟悉的領域中推進創新,從而實現長期成長。
So thank you all. Keep safe. Look forward to catching up with you on the next quarterly call.
所以,謝謝大家。注意安全。期待在下次季度電話會議上與您交流。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Thanks, everybody. Myself and the IR team will be around for some time, so feel free to reach out to us. Thanks again.
謝謝大家。我和投資者關係團隊還會在這裡待一段時間,所以歡迎隨時與我們聯繫。再次感謝。
Operator
Operator
Ladies and gentlemen, we thank you greatly for joining us for Amgen's First Quarter 2020 Financial Results Conference Call. This does conclude the call. You may now disconnect.
女士們、先生們,非常感謝各位參加安進公司2020年第一季財務業績電話會議。通話到此結束。您現在可以斷開連線了。