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Operator
Operator
Ladies and gentlemen, thank you for standing by.
女士們,先生們,謝謝你們的支持。
Welcome to the Lilly Q1 earnings conference call.
歡迎來到禮來公司第一季度財報電話會議。
(Operator Instructions) As a reminder, your conference call today is being recorded.
(操作員說明)作為提醒,您今天的電話會議正在錄音中。
I will now turn the conference call over to your host, Vice President of Investor Relations, Kevin Hern.
我現在將電話會議轉交給您的主持人,投資者關係副總裁 Kevin Hern。
Go ahead, please.
請繼續。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Good morning.
早上好。
Thank you for joining us for Eli Lilly and Company's Q1 2020 Earnings Call.
感謝您參加禮來公司 2020 年第一季度財報電話會議。
I'm Kevin Hern, Vice President of Investor Relations.
我是投資者關係副總裁 Kevin Hern。
Joining me on today's call are Dave Ricks, Lilly's Chairman and CEO; Josh Smiley, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific Officer; Anne White, President of Lilly Oncology; Patrik Jonsson, President of Lilly Bio-Medicines; and Mike Mason, President of Lilly Diabetes.
與我一起參加今天電話會議的還有禮來公司董事長兼首席執行官戴夫·里克斯(Dave Ricks);喬什·斯邁利,首席財務官; Dan Skovronsky 博士,首席科學官;禮來腫瘤學總裁 Anne White; Patrik Jonsson,禮來生物醫藥總裁;和禮來糖尿病公司總裁 Mike Mason。
We're also joined by Sara Smith and Mike Czapar of the Investor Relations team.
投資者關係團隊的 Sara Smith 和 Mike Czapar 也加入了我們的行列。
In addition, I would like to welcome Anat Hakim, who recently joined Lilly as Senior Vice President and General Counsel.
此外,我要歡迎最近加入禮來公司擔任高級副總裁兼總法律顧問的 Anat Hakim。
Anat joins Lilly with a wealth of experience in the health care industry, and more broadly, across the legal profession.
Anat 憑藉在醫療保健行業以及更廣泛的法律專業領域的豐富經驗加入禮來。
Her prior experiences include General Counsel at WellCare Health Plans, Associate General Counsel at Abbott as well as working for a number of years at Foley & Lardner and Latham & Watkins.
她之前的經驗包括 WellCare Health Plans 的總法律顧問、雅培的副總法律顧問以及在 Foley & Lardner 和 Latham & Watkins 工作多年。
During this conference call, we anticipate making projections and forward-looking statements based on our current expectations.
在這次電話會議期間,我們預計會根據我們目前的預期做出預測和前瞻性陳述。
Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic; as well as other factors listed on Slide 3; and those outlined in our latest Forms 10-K, 10-Q and any 8-Ks filed with the Securities and Exchange Commission.
由於多種因素,包括 COVID-19 大流行的影響程度和持續時間,我們的實際結果可能存在重大差異;以及幻燈片 3 中列出的其他因素;以及我們向證券交易委員會提交的最新 10-K、10-Q 表格和任何 8-K 表格中概述的內容。
The information we provide about our products and pipeline is for the benefit of the investment community.
我們提供的有關我們的產品和管道的信息是為了投資界的利益。
It is not intended to be promotional and is not sufficient for prescribing decisions.
它不是為了促銷,也不足以做出處方決定。
As we transition to our prepared remarks, a reminder that our commentary will focus on non-GAAP financial measures, which exclude the financial contribution from Elanco during 2019 and present earnings per share as though the full disposition via the exchange offer was complete on January 1, 2019.
當我們過渡到我們準備好的評論時,提醒我們的評論將集中在非公認會計準則財務指標上,其中不包括 Elanco 在 2019 年的財務貢獻和每股收益,就好像通過交換要約的全部處置已於 1 月 1 日完成, 2019 年。
Now I'll turn the call over to Dave for some opening comments.
現在,我將把電話轉給 Dave,以徵求一些開場白。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Thanks, Kevin.
謝謝,凱文。
Well, these are challenging times for all of us as the COVID-19 pandemic has affected the way we live, the way we conduct business, and most importantly, the health and wellness of millions of people.
好吧,這對我們所有人來說都是充滿挑戰的時刻,因為 COVID-19 大流行已經影響了我們的生活方式、我們開展業務的方式,最重要的是,影響了數百萬人的健康和福祉。
Like all of you, we're hopeful that the decisions to implement social distancing will be effective to curb the spread of COVID-19 as our industry works urgently to enhance testing and speed therapies to market to treat and then prevent the virus.
像你們所有人一樣,我們希望實施社會隔離的決定將有效遏制 COVID-19 的傳播,因為我們的行業正在緊急工作以加強檢測並加快將療法推向市場以治療然後預防病毒。
Today's call will have a different structure than normal.
今天的通話將具有與平時不同的結構。
Before we discuss our Q1 results, we'll describe the impact of COVID-19 and -- the pandemic in general is having on our business and the actions we have taken to respond to the resulting global crisis.
在討論我們的第一季度業績之前,我們將描述 COVID-19 的影響,以及大流行對我們的業務的總體影響以及我們為應對由此產生的全球危機而採取的行動。
Our Q1 results were driven by very strong fundamentals, with additional benefit from increased inventory across the supply chain, including at the patient level.
我們第一季度的業績受到非常強勁的基本面的推動,並從整個供應鏈的庫存增加中獲得了額外的好處,包括在患者層面。
This is as a result of the COVID-19 pandemic.
這是 COVID-19 大流行的結果。
Despite that near-term benefit, the COVID-19 pandemic is likely to have a negative impact on our business in the future.
儘管有短期利益,但 COVID-19 大流行可能會對我們未來的業務產生負面影響。
We expect headwinds later in 2020 and potentially beyond, such as destocking as supply chains normalize from the recent demand surge, decreases in new prescriptions as a result of fewer patients visiting physicians' offices, potential changes in segment mix in the U.S. due to rising unemployment and pricing pressures resulting from the fiscal strain on government-funded health care systems around the world.
我們預計 2020 年晚些時候及以後可能會遇到不利因素,例如隨著供應鏈因近期需求激增而正常化而去庫存,由於訪問醫生辦公室的患者減少導致新處方減少,由於失業率上升導緻美國細分市場組合的潛在變化世界各地政府資助的醫療保健系統的財政壓力導致的定價壓力。
While we do not yet know the extent and duration of these impacts, like everyone around the world, we're hopeful that the massive mobilization of scientific and technical resources occurring across this industry and in collaboration with government and academic labs will yield multiple effective therapies in the coming months and an effective vaccine in calendar '21.
雖然我們還不知道這些影響的程度和持續時間,但與世界各地的每個人一樣,我們希望整個行業以及與政府和學術實驗室合作的科學和技術資源的大規模動員將產生多種有效的療法在接下來的幾個月中,並在 '21 日曆中獲得有效的疫苗。
While it's difficult to predict the specifics of how the world manages through this pandemic, it seems clear our industry will play a leading role.
雖然很難預測世界如何度過這一流行病的具體細節,但我們的行業顯然將發揮主導作用。
In the midst of the outbreak and in its aftermath, it seems equally clear that investing in research and development to address and then conquer human disease has never been more important.
在疫情爆發期間和之後,似乎同樣清楚的是,投資於研發以解決並戰勝人類疾病從未像現在這樣重要。
And this is likely to remain true for some time.
這可能會在一段時間內保持不變。
As we've navigated the crisis, we've acted with speed and agility, focusing on the needs of patients, our employees and the communities we serve and operate in.
在度過危機的過程中,我們迅速而敏捷地採取行動,專注於滿足患者、我們的員工以及我們服務和運營所在社區的需求。
I'll provide a summary of our response, then Dan will describe our ongoing efforts to develop a treatment for COVID-19 and Josh will walk through potential financial impact of our outlook going forward.
我將簡要介紹我們的回應,然後 Dan 將描述我們為開發 COVID-19 治療方法所做的持續努力,而 Josh 將介紹我們未來前景的潛在財務影響。
Slide 4 summarizes our strategic approach and actions to date.
幻燈片 4 總結了我們迄今為止的戰略方法和行動。
As you can see, we focused on 5 areas: maintaining a safe supply of and access to our medicines, reducing the strain on the medical system, developing a treatment for the virus, keeping our employees safe and supporting our communities.
如您所見,我們專注於 5 個領域:維持藥品的安全供應和獲取、減輕醫療系統的壓力、開發病毒治療方法、保障員工安全和支持我們的社區。
To ensure that 40 million-plus patients we serve have access to their medicines, early in the outbreak, we took a number of steps to maintain the supply of medicines around the world.
為了確保我們服務的超過 4000 萬患者能夠獲得藥物,在疫情爆發初期,我們採取了一系列措施來維持全球的藥物供應。
To limit their exposure to the virus, we reduced personnel at our manufacturing sites to the bare minimum required to operate our facilities, and enhanced already robust precautionary measures for safety and cleanliness.
為了限制他們接觸病毒,我們將生產基地的人員減少到運營設施所需的最低限度,並加強了已經強有力的安全和清潔預防措施。
The majority of our supply chain is multisourced.
我們的大部分供應鏈都是多源的。
And for materials we supply from one source, we keep sufficient inventory on hand to avoid disruptions.
對於我們從一個來源供應的材料,我們手頭有足夠的庫存以避免中斷。
Even with increased demand and customer stocking, we have sufficient inventory and production capacity for all our products.
即使需求和客戶庫存增加,我們的所有產品都有足夠的庫存和生產能力。
This includes all forms of insulin.
這包括所有形式的胰島素。
And we don't currently anticipate any issues meeting patient needs through the remainder of the pandemic.
我們目前預計在大流行的剩餘時間內不會出現任何滿足患者需求的問題。
Our manufacturing sites in the U.S., Europe and China have remained operational through this crisis.
我們在美國、歐洲和中國的製造基地在這場危機中一直保持運轉。
We're proud of the extraordinary efforts of our manufacturing colleagues who've worked diligently to supply our medicines to patients around the world who depend on them.
我們為我們的製造同事的非凡努力感到自豪,他們努力工作,為世界各地依賴我們的患者提供我們的藥物。
In addition to the numerous programs currently available through the Lilly Diabetes Solution Center, we announced the introduction of the Insulin Value Program.
除了目前通過禮來糖尿病解決方案中心提供的眾多計劃外,我們還宣布推出胰島素價值計劃。
This allows patients with commercial insurance or without insurance to limit their monthly out-of-pocket expenses for insulin to $35 per prescription.
這使得有商業保險或沒有保險的患者可以將他們每月的胰島素自付費用限制在每個處方 35 美元。
Of note, the solution center has seen a significant increase in daily calls since this new benefit was announced.
值得注意的是,自宣布這項新福利以來,解決方案中心的每日通話量顯著增加。
Patient affordability continues to be a top priority, and we remain committed to helping people access the medicines they need.
患者負擔能力仍然是重中之重,我們仍然致力於幫助人們獲得所需的藥物。
We've also made a number of decisions, which reduced the strain on the medical system.
我們還做出了一些決定,減輕了醫療系統的壓力。
These include: pausing new clinical starts and enrollment for most ongoing programs, suspending our in person customer visits to physicians, repurposing our labs to conduct diagnostic testing here in Indiana for COVID-19, and creating a drive-through testing facility for health care workers and first responders in the Indianapolis area.
其中包括:暫停大多數正在進行的項目的新臨床開始和註冊,暫停我們的客戶親自拜訪醫生,重新利用我們的實驗室在印第安納州對 COVID-19 進行診斷測試,並為醫療保健工作者創建一個直通式測試設施和印第安納波利斯地區的急救人員。
We took these actions because they are the right thing to do during these challenging times and to do our part to combat the spread of COVID-19.
我們採取這些行動是因為它們是在這些充滿挑戰的時期做的正確的事情,並為抗擊 COVID-19 的傳播盡我們的一份力量。
Dan will give a more complete pipeline update later, but I would like to highlight that we do not expect significant changes to the timelines for our ongoing late-stage studies, except for the previously announced delays for the GI indications of our IL-23 antibody, mirikizumab.
Dan 稍後將提供更完整的管道更新,但我想強調的是,除了之前宣布的 IL-23 抗體的 GI 適應症延遲外,我們預計正在進行的後期研究的時間表不會發生重大變化,米利珠單抗。
In terms of addressing the significant unmet need of treating COVID-19, we've acted upon several opportunities, which we hope will result in a treatment option.
在解決治療 COVID-19 的重大未滿足需求方面,我們已經採取了一些機會,我們希望這將產生一種治療選擇。
These include partnering with AbCellera to develop potential antibody therapies, which we expect will enter the clinic this summer; participating in the National Institute of Allergy and Infectious Disease, Adaptive COVID-19 Treatment Trial with our JAK inhibitor, baricitinib; initiating a Phase II clinical trial with an antibody-targeting Angiopoietin-2 to explore its potential use in reducing the progression of acute respiratory distress syndrome related to COVID-19.
其中包括與 AbCelera 合作開發潛在的抗體療法,我們預計該療法將在今年夏天進入臨床;使用我們的 JAK 抑製劑巴瑞替尼參與美國國家過敏和傳染病研究所的適應性 COVID-19 治療試驗;啟動針對抗體的血管生成素-2的 II 期臨床試驗,以探索其在減少與 COVID-19相關的急性呼吸窘迫綜合徵進展方面的潛在用途。
The need for new medicines is urgent, and we've mobilized our development team at a record pace.
迫切需要新藥,我們以創紀錄的速度動員了我們的開發團隊。
Keeping our employees safe and healthy and our company running smoothly is, of course, also a top priority.
確保我們的員工安全和健康以及我們公司的順利運行當然也是重中之重。
We've implemented remote work practices, added health and wellness benefits and provided additional compensation for those essential employees routinely coming to our sites, such as those in manufacturing.
我們已經實施了遠程工作實踐,增加了健康和保健福利,並為那些經常來我們工廠的重要員工(例如製造業的員工)提供了額外的補償。
We've also created opportunities for employees to volunteer during work hours to support our medical system, including helping staff our drive-through testing facility.
我們還為員工創造了在工作時間做志願者的機會,以支持我們的醫療系統,包括幫助員工我們的免下車檢測設施。
To date, Lilly has tested nearly 30,000 people for COVID-19, which represents over 1/3 of all tests conducted in the state of Indiana, while absorbing all associated expenses.
迄今為止,禮來已對近 30,000 人進行了 COVID-19 檢測,佔印第安納州所有檢測的 1/3 以上,同時承擔了所有相關費用。
We are building on this capacity by developing serological antibody tests that will be critical in the next phase of the pandemic.
我們正在通過開發對下一階段大流行至關重要的血清抗體測試來建立這種能力。
In addition, we've been supporting our local communities by funding or contributing to public health awareness campaigns as well as providing assistance and deploying available resources to fight the pandemic.
此外,我們一直通過資助或參與公共衛生宣傳活動以及提供援助和部署可用資源來抗擊這一流行病來支持我們的當地社區。
I would also note our appreciation for the high level of responsiveness and cooperation from the FDA and other government agencies in the U.S. and abroad as we partner together to fight COVID-19 and to minimize the negative impact to drug development timelines for our other innovative medicines.
我還要感謝 FDA 和美國和國外其他政府機構的高水平響應和合作,因為我們攜手抗擊 COVID-19,並儘量減少對我們其他創新藥物的藥物開發時間表的負面影響.
Across the biopharmaceutical industry, we're working around the clock, collectively driving forward to address the acute medical need created by the COVID-19 pandemic.
在整個生物製藥行業,我們都在夜以繼日地工作,共同推動解決 COVID-19 大流行造成的緊急醫療需求。
And to further elaborate on that, I'll turn the call over now to Dan to provide more details on the ongoing efforts to treat COVID-19 and a regular pipeline update.
為了進一步詳細說明這一點,我現在將電話轉給 Dan,以提供更多關於治療 COVID-19 的持續努力和定期管道更新的詳細信息。
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Thanks, Dave.
謝謝,戴夫。
I'm proud to highlight the ongoing efforts we have to combat COVID-19.
我很自豪地強調我們為對抗 COVID-19 所做的持續努力。
As Dave mentioned earlier, we're moving at an unprecedented pace as part of an industry-wide effort to develop a treatment for COVID-19.
正如 Dave 之前提到的,作為全行業開發 COVID-19 治療方法的一部分,我們正以前所未有的速度前進。
As a scientist and as a physician, I'm incredibly impressed and thankful for the ways our teams at Lilly are working to make an impact against this new disease.
作為一名科學家和一名醫生,禮來公司的團隊為對抗這種新疾病所做的努力給我留下了非常深刻的印象和感謝。
We've demonstrated how nimble a large organization can be when truly focused and united behind an important cause.
我們已經展示了一個大型組織在真正專注和團結在一項重要事業之後是多麼靈活。
Slide 5 provides an overview of the 3 active therapeutic programs we are pursuing.
幻燈片 5 概述了我們正在追求的 3 個積極的治療計劃。
First is baricitinib.
首先是巴瑞替尼。
This is our JAK inhibitor in collaboration with Incyte.
這是我們與 Incyte 合作的 JAK 抑製劑。
It is recently -- we have recently announced it is part of the National Institute of Allergy and Infectious Disease Adaptive COVID-19 Treatment Trial.
最近——我們最近宣布它是美國國家過敏和傳染病研究所適應性 COVID-19 治療試驗的一部分。
Based on the known anti-inflammatory activity of baricitinib, recent data in preclinical studies and case reports from investigator-sponsored clinical trials, we believe baricitinib could have potential to dampen the cytokine storm that occurs when hospitalized COVID-19 patients are fighting to combat the inflammation in their lungs, which often leads to requiring a ventilator.
根據巴瑞克替尼已知的抗炎活性、臨床前研究的最新數據和研究者贊助的臨床試驗的病例報告,我們認為巴瑞替尼可能會抑制住院 COVID-19 患者抗擊新冠肺炎時發生的細胞因子風暴。他們的肺部發炎,這通常導致需要呼吸機。
While we're cautiously optimistic about the potential of baricitinib to help treat patients with COVID-19, it's important to also note the approved rheumatoid arthritis indication includes warnings about the risk for developing serious infection.
雖然我們對巴瑞克替尼幫助治療 COVID-19 患者的潛力持謹慎樂觀態度,但還需要注意的是,批准的類風濕關節炎適應症包括對發生嚴重感染風險的警告。
The baricitinib arm of this study begins this month in the U.S. with planned expansion to Europe and Asia, and results are expected in the next 2 months.
本研究的巴瑞替尼分支於本月在美國開始,計劃擴展到歐洲和亞洲,預計將在未來 2 個月內取得結果。
Next, we started a Phase II trial with a monoclonal antibody against Angiopoietin-2 or Ang-2 in pneumonia patients hospitalized with COVID-19 who were at a higher risk of progressing to acute respiratory distress syndrome, or ARDS.
接下來,我們在 COVID-19 住院的肺炎患者中開始了一項針對血管生成素-2 或 Ang-2 的單克隆抗體的 II 期試驗,這些患者發展為急性呼吸窘迫綜合徵 (ARDS) 的風險較高。
The Ang-2 level in plasma is strongly correlated with ARDS risk and severity based on multiple studies in humans.
根據多項人體研究,血漿中的 Ang-2 水平與 ARDS 風險和嚴重程度密切相關。
Our trial will test whether inhibiting the effects of Ang-2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation.
我們的試驗將測試用單克隆抗體抑制 Ang-2 的作用是否可以減少 ARDS 的進展或機械通氣的需要。
This trial has already begun enrolling patients at centers across the United States.
該試驗已經開始在美國各地的中心招募患者。
We expect results from this trial in the coming months.
我們預計未來幾個月該試驗的結果。
Our third and potentially most significant program is part of our previously announced collaboration with AbCellera, where we are pursuing antibody therapies for the potential treatment and prevention of COVID-19.
我們的第三個也是可能最重要的計劃是我們之前宣布的與 AbCelera 合作的一部分,我們正在尋求抗體療法以潛在地治療和預防 COVID-19。
Our scientists have been working together with AbCellera, NIH and academic partners to characterize virus-neutralizing antibodies obtained from one of the first U.S. patients who recovered from the virus.
我們的科學家一直在與 AbCelera、NIH 和學術合作夥伴合作,對從第一批從病毒中康復的美國患者中獲得的病毒中和抗體進行鑑定。
The most advanced antibody in this program shows potent neutralization of live virus and has now entered GMP manufacturing.
該項目中最先進的抗體顯示出對活病毒的有效中和作用,現已進入 GMP 生產。
We plan to submit an IND to the FDA by the end of May to allow start of clinical testing in patients.
我們計劃在 5 月底之前向 FDA 提交 IND,以便開始對患者進行臨床試驗。
The pace at which we've advanced these potential treatments has been possible due to the tireless efforts of our research and development colleagues in partnership with a number of private and government partners.
由於我們的研發同事與許多私人和政府合作夥伴的不懈努力,我們推進這些潛在治療的速度成為可能。
The need for treatment options to battle COVID-19 is staggering, and we are leveraging our financial resources and our very significant scientific capabilities to rapidly pursue solutions.
對抗 COVID-19 的治療方案的需求是驚人的,我們正在利用我們的財政資源和我們非常重要的科學能力來快速尋求解決方案。
The challenges facing our society and our economy are great, and the pharmaceutical industry is rising to the challenge.
我們的社會和經濟面臨著巨大的挑戰,製藥行業正在迎接挑戰。
I'll now provide a brief pipeline update.
我現在將提供一個簡短的管道更新。
Slide 6 shows select pipeline opportunities as of April 20.
幻燈片 6 顯示了截至 4 月 20 日的選定管道機會。
Movement since our last earnings call includes the approval of Lyumjev in the EU and Japan, the U.S. approval of Taltz for pediatric psoriasis, the previously mentioned COVID-19 trial initiations for baricitinib and Ang-2, one program advancing to Phase I, the attrition of an early phase project and the removal of empagliflozin for type 1 diabetes based on a complete response letter from the FDA.
自我們上次財報電話會議以來的變動包括歐盟和日本批准 Lyumjev、美國批准 Taltz 治療兒科銀屑病、前面提到的巴瑞替尼和 Ang-2 的 COVID-19 試驗啟動、一個進入 I 期的項目、減員根據 FDA 的完整回复信,對早期項目和 empagliflozin 用於 1 型糖尿病的去除。
Moving to Slide 7. We provide an update on our 2020 key events that have occurred during the quarter.
轉到幻燈片 7。我們提供了本季度發生的 2020 年關鍵事件的最新信息。
In addition to the previously mentioned approvals, we also announced the first of 2 Phase III trials studying mirikizumab in psoriasis met its primary end point; the submission of tanezumab in Europe for moderate-to-severe osteoarthritis pain in collaboration with Pfizer; the DIAN-TU trial for solanezumab, which did not meet its primary end point; and galcanezumab received a negative opinion from the CHMP for cluster headache in Europe.
除了前面提到的批准,我們還宣布了 2 個研究 mirikizumab 治療銀屑病的 III 期試驗中的第一個達到了主要終點;與輝瑞合作在歐洲提交 tanezumab 治療中度至重度骨關節炎疼痛; solanezumab 的 DIAN-TU 試驗,未達到主要終點; galcanezumab 在歐洲的叢集性頭痛方面收到了 CHMP 的否定意見。
Before I close the R&D update, I'd like to emphasize that in addition to our ongoing efforts to combat COVID-19, we remain committed to advancing important new medicines across our entire portfolio.
在我結束研發更新之前,我想強調的是,除了我們持續努力抗擊 COVID-19 之外,我們仍然致力於在我們的整個產品組合中推進重要的新藥。
Although we announced our pause to new trial starts and enrollment in most programs, we remain committed to discovering and developing new treatments for the patients we serve.
儘管我們宣布暫停新的試驗開始和大多數項目的註冊,但我們仍然致力於為我們服務的患者發現和開發新的治療方法。
With the exception of mirikizumab for GI indications, our late-stage portfolio remains on track to deliver important clinical trial data, in line with our previously communicated timelines.
除了用於 GI 適應症的 mirikizumab 外,我們的後期產品組合仍有望按照我們之前傳達的時間表提供重要的臨床試驗數據。
Of note, the tirzepatide SURPASS program in type 2 diabetes is fully enrolled, and we expect to share the first Phase III trial results later this year.
值得注意的是,2 型糖尿病的 tirzepatide SURPASS 計劃已全部註冊,我們預計將在今年晚些時候分享第一個 III 期試驗結果。
These are challenging times around the world, but I'm encouraged by the unprecedented response of the scientific community and the pharmaceutical industry to rapidly develop potential new treatments and vaccines for COVID-19 and to sustain advancements across all diseases.
這是世界各地充滿挑戰的時代,但我對科學界和製藥業為迅速開發潛在的 COVID-19 新療法和疫苗並維持所有疾病的進步做出前所未有的反應感到鼓舞。
Now I'll turn the call over to Josh to discuss the impact of COVID-19 on our Q1 financial performance and our outlook going forward.
現在,我將把電話轉給 Josh,討論 COVID-19 對我們第一季度財務業績和未來前景的影響。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Thank you, Dan, and good morning, everyone.
謝謝你,丹,大家早上好。
As Dave shared earlier, we are confident that our business fundamentals are strong and that we're well positioned to navigate the obstacles ahead.
正如戴夫早些時候分享的那樣,我們相信我們的業務基礎是強大的,並且我們已經做好了應對前方障礙的準備。
However, there undoubtedly will be a near-term impact to our industry and our company, though the length and magnitude of the effects are uncertain.
然而,無疑會對我們的行業和我們的公司產生近期影響,儘管影響的長度和幅度尚不確定。
So I'll spend a few minutes discussing the financial impact of COVID-19 on our Q1 performance and providing a framework for how we are thinking about this potential impact going forward before then providing a more detailed review of our financial results.
因此,我將花幾分鐘時間討論 COVID-19 對我們第一季度業績的財務影響,並提供一個框架來說明我們如何考慮這種潛在影響,然後再對我們的財務業績進行更詳細的審查。
We began 2020 with positive momentum and observed robust prescription trends in January and February.
我們以積極的勢頭開始了 2020 年,並在 1 月和 2 月觀察到了強勁的處方趨勢。
As COVID-19 spread throughout the world and economic activity slowed significantly in many cities and regions, we observed the following changes and behaviors that affected our business: patients refilled existing prescriptions earlier than normal or bought a larger supply to ensure that they didn't run out, wholesalers and retailers increased the level of inventory on hand to ensure adequate supply, reduced hospital visits resulted in a preference for medicines that do not require administration in a physician's office or at a hospital, patients abandoned fewer prescriptions at the pharmacy counter, mail-order utilization increased which typically has a larger number of units per prescription than those filled at retail pharmacies, and new therapy starts slowed as patients largely avoided hospitals and clinics, unless they were seeking treatment for COVID-19.
隨著 COVID-19 在全球蔓延,許多城市和地區的經濟活動顯著放緩,我們觀察到以下影響我們業務的變化和行為:患者比正常情況更早重新填寫現有處方或購買更多供應以確保他們沒有用完後,批發商和零售商增加了庫存水平以確保充足的供應,減少醫院就診次數導致偏愛不需要在醫生辦公室或醫院管理的藥物,患者在藥房櫃檯放棄的處方減少,郵購使用率增加,每個處方的單位數量通常比零售藥房的數量多,並且由於患者基本上避開醫院和診所,除非他們正在尋求 COVID-19 的治療,新的治療開始放緩。
We estimate the net impact of these trends resulted in increased patient and channel stocking, which increased worldwide sales by roughly $250 million in Q1, with approximately $200 million of that impact in the U.S. We think the majority of the U.S. impact occurred in our diabetes portfolio and notable products where we believe increased stocking impacted our Q1 U.S. results include: Insulin by approximately $70 million to $80 million, Trulicity by approximately $30 million to $40 million and Taltz by approximately $20 million to $25 million.
我們估計這些趨勢的淨影響導致患者和渠道庫存增加,第一季度全球銷售額增加了約 2.5 億美元,其中約 2 億美元在美國。我們認為美國的大部分影響發生在我們的糖尿病產品組合中我們認為庫存增加影響我們第一季度美國業績的值得注意的產品包括:胰島素增加約 7000 萬美元至 8000 萬美元,Trulicity 增加約 3000 萬美元至 4000 萬美元,Taltz 增加約 2000 萬美元至 2500 萬美元。
While we expect much of this stocking to reverse in future quarters as the excess supply in the channel and in patients medicine cabinets is consumed, the timing and ultimate levels are uncertain.
雖然我們預計隨著渠道和患者藥櫃中的過剩供應被消耗,這種庫存的大部分將在未來幾個季度逆轉,但時間和最終水平尚不確定。
We continue to closely monitor these factors and will utilize our quarterly earnings calls to provide updates to our outlook.
我們將繼續密切關注這些因素,並將利用我們的季度收益電話會議來更新我們的展望。
Slide 8 lists a number of factors we are monitoring that may impact our financial performance.
幻燈片 8 列出了我們正在監測的可能影響我們財務業績的一些因素。
While reduced new therapy starts had a negligible impact during Q1, this impact could grow in future periods as fewer new starts translates into fewer total prescription.
雖然減少新療法開始在第一季度的影響可以忽略不計,但這種影響在未來時期可能會增加,因為更少的新開始轉化為更少的總處方。
In the U.S., we are starting to see an impact as IQVIA reported new-to-brand prescriptions across the industry declined by 42% for the week ending April 10 versus pre-COVID-19 averages.
在美國,我們開始看到影響,因為 IQVIA 報告稱,截至 4 月 10 日的一周,整個行業的新品牌處方與 COVID-19 之前的平均水平相比下降了 42%。
For our portfolio, we anticipate this impact to be more pronounced for our immunology and pain products and less so for oncology and diabetes.
對於我們的產品組合,我們預計這種影響對我們的免疫學和疼痛產品更為明顯,而對腫瘤學和糖尿病的影響則較小。
However, we expect this impact to be temporary as patients will return to seeing their doctors as social distancing restrictions are lifted.
但是,我們預計這種影響將是暫時的,因為隨著社交距離限制的解除,患者將返回看醫生。
Over the midterm, the significant increase in unemployment we are seeing could be a headwind.
從中期來看,我們看到的失業率大幅上升可能是不利因素。
Increased unemployment may result in a shift of patients from commercial insurance to lower net price government insurance in the U.S. or to being uninsured.
失業率上升可能導致患者從商業保險轉向美國淨價較低的政府保險,或轉向無保險。
We're monitoring this dynamic closely.
我們正在密切關注這一動態。
And while it could create headwinds in the near term, this effect should lessen when the global economy eventually strengthens.
雖然它可能在短期內造成不利影響,但當全球經濟最終走強時,這種影響應該會減弱。
Given the significant benefits our products provide to 40 million patients around the world, we remain confident in our long-term outlook for revenue growth and margin expansion.
鑑於我們的產品為全球 4000 萬患者帶來的顯著益處,我們對收入增長和利潤增長的長期前景充滿信心。
In terms of managing capital, our balance sheet and liquidity are strong, and we have investment-grade ratings from both Moody's and S&P.
在管理資本方面,我們的資產負債表和流動性很強,我們獲得了穆迪和標準普爾的投資級評級。
We're confident in our ability to generate substantial operating cash flow and have not seen an impact to our ability to access capital markets, including commercial paper at reasonable rates.
我們對我們產生大量經營現金流的能力充滿信心,並且沒有看到我們進入資本市場的能力受到影響,包括以合理的利率獲得商業票據。
Financial strength is a valuable asset during this period, and we intend to maintain our current credit ratings while using our balance sheet capacity to invest in the business and pursue business development opportunities that enhance our future growth prospects.
在此期間,財務實力是一項寶貴的資產,我們打算維持我們目前的信用評級,同時利用我們的資產負債表能力投資於業務並尋求可增強我們未來增長前景的業務發展機會。
I'll provide more details on our 2020 outlook shortly, but in summary, we do expect the impact on our financial results through the remainder of the year and potentially into 2021, but the underlying strength and momentum in our business is strong.
我將很快提供有關我們 2020 年展望的更多細節,但總而言之,我們確實預計在今年剩餘時間和可能到 2021 年對我們的財務業績產生影響,但我們業務的潛在實力和勢頭強勁。
While combating the COVID-19 pandemic is a top priority, we remain focused on executing our strategy of developing new medicines for patients.
雖然抗擊 COVID-19 大流行是當務之急,但我們仍然專注於執行我們為患者開發新藥的戰略。
We exited 2019 with very strong momentum in revenue growth and margin expansion, driven by the uptake of our newer products.
在我們新產品的採用的推動下,我們以非常強勁的收入增長和利潤率擴張勢頭退出了 2019 年。
On Slide 9, you will see that momentum continued in Q1 2020 as we delivered strong underlying business performance, augmented by the estimated COVID-19-related buying patterns from patients and customers I just described.
在幻燈片 9 上,您將看到 2020 年第一季度繼續保持這種勢頭,因為我們提供了強勁的潛在業務表現,而我剛剛描述的患者和客戶估計的與 COVID-19 相關的購買模式進一步增強了這種勢頭。
Revenue growth accelerated in Q1, increasing 15% versus Q1 2019 or 16% in constant currency.
第一季度收入增長加速,與 2019 年第一季度相比增長 15%,按固定匯率計算增長 16%。
This strong performance was driven by volume, which contributed 22 percentage points of growth.
這種強勁的表現是由銷量推動的,銷量增長了 22 個百分點。
Net of the estimated COVID-19 impact, revenue growth was 11% for the quarter in constant currency.
扣除估計的 COVID-19 影響後,按固定匯率計算,本季度收入增長 11%。
Our newer medicines continue to be the driver of this growth, representing more than half of our revenue in the quarter.
我們的新藥繼續成為這一增長的驅動力,占我們本季度收入的一半以上。
We made good progress in Q1 on our productivity agenda as operating income grew 32% versus last year.
我們在第一季度的生產力議程上取得了良好進展,營業收入與去年相比增長了 32%。
Our non-GAAP operating margin improved by 390 basis points to 30.1% as revenue growth outpaced operating expenses.
由於收入增長超過運營費用,我們的非美國通用會計準則營業利潤率提高了 390 個基點至 30.1%。
The estimated impact of COVID-19 buying patterns in the quarter also had a positive impact on our non-GAAP operating margin.
本季度 COVID-19 購買模式的估計影響也對我們的非公認會計原則營業利潤率產生了積極影響。
But as we discussed during our 2020 financial guidance call, we expect our 2020 operating margin to build throughout the year to achieve our 2020 target for the full year of 31%.
但正如我們在 2020 年財務指導電話會議中所討論的,我們預計 2020 年的營業利潤率將在全年建立,以實現 2020 年全年 31% 的目標。
We've announced multiple pipeline milestones since our Q4 2019 earnings call, including approval of Lyumjev in Europe and Japan and new indications for both Trulicity and Taltz in the U.S.
自 2019 年第四季度財報電話會議以來,我們宣布了多個管道里程碑,包括歐洲和日本的 Lyumjev 批准以及美國 Trulicity 和 Taltz 的新適應症。
During Q1, we returned approximately $1.2 billion to shareholders via share repurchases and the dividend.
在第一季度,我們通過股票回購和股息向股東返還了大約 12 億美元。
As previously announced, we increased the dividend by 15% for 2020.
正如之前宣布的,我們將 2020 年的股息提高了 15%。
At this point, we do not expect to make additional share repurchases in the near term in order to maintain a cushion of liquidity and capacity for investment and continued dividend growth.
在這一點上,我們預計短期內不會進行額外的股票回購,以保持流動性和投資能力的緩衝以及持續的股息增長。
Finally, we closed the acquisition of Dermira, a company focused on developing new therapies for chronic skin conditions, enhancing our Phase III pipeline with the addition of lebrikizumab, which is complementary to our dermatology business.
最後,我們完成了對 Dermira 的收購,該公司專注於開發慢性皮膚病的新療法,通過添加 lebrikizumab 來增強我們的 III 期管道,這是對我們皮膚科業務的補充。
Slide 10 includes a summary of key events since our last earnings call.
幻燈片 10 包括自上次財報電話會議以來的關鍵事件摘要。
Moving to Slide 11.
轉到幻燈片 11。
Our non-GAAP financial performance in Q1 was robust even when adjusting for the COVID-19 impact described earlier.
即使根據前面描述的 COVID-19 影響進行調整,我們在第一季度的非公認會計原則財務業績也很強勁。
In addition to strong top line performance, gross margin as a percent of revenue was stable versus Q1 2019 at approximately 80% as favorable product mix and greater manufacturing efficiencies were partially offset by price and increased costs associated with COVID-19.
除了強勁的頂線表現外,毛利率佔收入的百分比與 2019 年第一季度相比穩定在約 80%,因為有利的產品組合和更高的製造效率被價格和與 COVID-19 相關的成本增加部分抵消。
Moving down the P&L.
向下移動損益表。
Operating expenses grew slower than revenue at 7% versus last year's quarter.
與去年同期相比,運營費用的增長速度低於收入的 7%。
Marketing, selling and administrative expenses increased modestly by 2% as cost-containment and productivity measures offset investments in key growth products.
由於成本控制和生產力措施抵消了對關鍵增長產品的投資,營銷、銷售和管理費用小幅增長了 2%。
Travel restrictions and the suspension of in-person customer interactions late in the quarter did result in lower travel and meeting expenses.
本季度末旅行限制和麵對面客戶互動的暫停確實導致旅行和會議費用降低。
However, these were offset by a higher U.S.-branded prescription drug manufacturing fee that we recognized in Q1.
然而,這些被我們在第一季度確認的更高的美國品牌處方藥製造費所抵消。
R&D expenses grew 13%, reflecting higher development expenses for late-stage assets that increased throughout 2019.
研發費用增長 13%,反映出 2019 年後期資產的開發費用增加。
Our pause on clinical trial starts had limited impact in Q1.
我們暫停臨床試驗在第一季度的影響有限。
Operating income increased 32% compared to Q1 2019 as sales growth outpaced expense growth, resulting in operating income as a percent of revenue of 30.1% for the quarter.
與 2019 年第一季度相比,營業收入增長了 32%,因為銷售額增長超過了費用增長,導致該季度營業收入佔收入的百分比為 30.1%。
We begin 2020 with good momentum executing our strategy and are on track to achieve our 2020 full year operating margin target of 31%.
我們在 2020 年開始時以良好的勢頭執行我們的戰略,並有望實現 2020 年全年 31% 的營業利潤率目標。
Other income and expense was income of $89 million this quarter compared to income of $86 million in Q1 2019.
其他收入和支出為本季度的收入為 8900 萬美元,而 2019 年第一季度的收入為 8600 萬美元。
In both quarters, this was driven by investment gains on public equities.
在這兩個季度,這都是由公共股票的投資收益推動的。
Mark-to-market gains in Q1 2020 were primarily generated by prior equity investments in companies that are now pursuing vaccines for COVID-19.
2020 年第一季度按市值計價的收益主要來自之前對正在尋求 COVID-19 疫苗的公司的股權投資。
As we regularly highlight, this line item can be volatile as public market valuations fluctuate.
正如我們經常強調的那樣,隨著公開市場估值的波動,該項目可能會出現波動。
Our tax rate was 13.6%, an increase of 70 basis points compared with the same quarter last year driven primarily by the mix of earnings in higher tax jurisdictions, partially offset by an increase in net discrete tax benefits.
我們的稅率為 13.6%,與去年同期相比增加了 70 個基點,這主要是由於較高稅收管轄區的收入組合,部分被淨離散稅收優惠的增加所抵消。
So at the bottom line, earnings per share increased 32%.
因此,最終每股收益增長了 32%。
On Slide 12, we quantify the effect of price, rate and volume on revenue growth.
在幻燈片 12 中,我們量化了價格、費率和數量對收入增長的影響。
As mentioned earlier, worldwide revenue grew 16% in constant currency during Q1 driven by strong volume growth of 22%, which we estimate at 17% net of the impact of COVID-19 buying patterns.
如前所述,在 22% 的強勁銷量增長推動下,第一季度全球收入按固定匯率計算增長了 16%,我們估計扣除 COVID-19 購買模式的影響後將增長 17%。
This was partially offset by price.
這部分被價格所抵消。
Foreign exchange had a modest negative impact on revenue growth this quarter.
外匯對本季度的收入增長產生了適度的負面影響。
Price declined 3% net of the price impact from the inclusion of Tyvyt and Alimta in government-sponsored programs in China.
扣除 Tyvyt 和 Alimta 加入中國政府資助項目的價格影響後,價格下降了 3%。
U.S. revenue grew 15% compared to the first quarter of 2019.
與 2019 年第一季度相比,美國收入增長了 15%。
Volume growth of 19% was led by Trulicity, Humalog, Taltz, Alimta, Verzenio, Emgality and Basaglar.
Trulicity、Humalog、Taltz、Alimta、Verzenio、Emgality 和 Basaglar 的銷量增長了 19%。
As I mentioned earlier, we saw stocking at the wholesale and patient level due to COVID-19 that contributed approximately $200 million of revenue this quarter.
正如我之前提到的,由於 COVID-19,我們看到批發和患者級別的庫存在本季度貢獻了約 2 億美元的收入。
While the situation remains fluid, we do expect this impact to largely reverse over the course of 2020.
儘管情況仍然不穩定,但我們確實預計這種影響將在 2020 年期間大幅扭轉。
Pricing was a 4% drag on U.S. revenue growth this quarter, in line with our 2020 guidance.
定價對本季度美國收入增長造成 4% 的拖累,符合我們 2020 年的預期。
This was driven primarily by growth in lower net price segments, primarily driven by our diabetes products, which was partially offset by changes to estimates for rebates and discounts for Taltz, and reduced utilization of patient assistance programs for Emgality due to increased commercial reimbursement.
這主要是由較低淨價格部分的增長推動的,主要是由我們的糖尿病產品推動的,這部分被 Taltz 回扣和折扣估計的變化所抵消,以及由於商業報銷增加導致 Emgality 患者援助計劃的使用減少。
We have strong commercial and Medicare Part D access across the portfolio, and that remained intact throughout Q1.
我們在整個投資組合中擁有強大的商業和醫療保險 D 部分訪問權限,並且在整個第一季度保持不變。
Moving to Europe.
搬到歐洲。
Revenue grew 21% in constant currency driven by 24% volume growth, partially offset by the negative effect of foreign exchange and price.
在銷量增長 24% 的推動下,按固定匯率計算的收入增長了 21%,部分被外彙和價格的負面影響所抵消。
Volume growth was led by Trulicity, Olumiant, Taltz and Verzenio and also benefited from the divestiture of a legacy product in Spain.
銷量增長由 Trulicity、Olumiant、Taltz 和 Verzenio 引領,並受益於西班牙傳統產品的剝離。
We estimate total international results were impacted by approximately $50 million of stocking due to the impact of COVID-19 in Q1, and the significant majority of this occurred in Europe.
我們估計,由於第一季度 COVID-19 的影響,國際總業績受到了大約 5000 萬美元的庫存影響,其中大部分發生在歐洲。
However, the underlying trends are very strong as our newer products have continued to scale.
然而,隨著我們的新產品繼續擴大規模,潛在趨勢非常強勁。
In Japan, revenue grew 8% in constant currency driven by volume growth, somewhat offset by a modest pricing headwind due to government-mandated price decreases that went into effect in 2019.
在日本,在銷量增長的推動下,按固定匯率計算的收入增長了 8%,這在一定程度上被 2019 年生效的政府強制降價導致的適度定價逆風所抵消。
Verzenio, Cyramza, Trulicity, Olumiant and Alimta were the key contributors to growth, partially offset by increased competition for Forteo and the impact of generic Straterra.
Verzenio、Cyramza、Trulicity、Olumiant 和 Alimta 是增長的主要貢獻者,部分被 Forteo 競爭加劇和通用 Straterra 的影響所抵消。
In China, revenue grew 30% in constant currency driven by 93% volume growth, partially offset by pricing concessions associated with the inclusion of Tyvyt and Alimta in government-sponsored programs.
在中國,由於銷量增長 93%,按固定匯率計算的收入增長了 30%,但部分抵消了將 Tyvyt 和 Alimta 納入政府資助項目相關的定價優惠。
We are very pleased with the significant volume increases we saw for these products and our ability to increase access for patients to these important cancer medicines.
我們對這些產品的銷量顯著增長以及我們增加患者獲得這些重要癌症藥物的能力感到非常高興。
Outside of Tyvyt and Alimta, our business in China saw a meaningfully -- a meaningful decline in new patient starts during Q1 as the COVID-19 spread peaked during March.
在 Tyvyt 和 Alimta 之外,我們在中國的業務出現了有意義的變化——隨著 COVID-19 傳播在 3 月達到頂峰,第一季度新患者開始出現有意義的下降。
As the situation appears to be moving toward more stability, we are cautiously encouraged that new patient initiations and in-person customer interactions have begun to resume.
隨著情況似乎正朝著更加穩定的方向發展,我們謹慎地鼓勵新的患者啟動和麵對面的客戶互動已經開始恢復。
Revenue in the rest of the world increased 14% in constant currency driven by increased volume from our key growth drivers: Trulicity, Jardiance in collaboration with Boehringer Ingelheim, Taltz, Cialis and Cyramza drove growth in Q1.
世界其他地區的收入按固定匯率計算增長了 14%,這是由於我們的主要增長驅動因素的銷量增加:Trulicity、Jardiance 與勃林格殷格翰、Taltz、Cialis 和 Cyramza 合作推動了第一季度的增長。
As shown on Slide 13, our key growth products continue to drive impressive worldwide volume growth.
如幻燈片 13 所示,我們的主要增長產品繼續推動全球銷量增長。
These new medicines delivered nearly 20 percentage points of growth this quarter, while also benefiting from the increased stocking that I described earlier.
這些新藥在本季度實現了近 20 個百分點的增長,同時也受益於我之前描述的庫存增加。
Slide 14 highlights the contributions of our key growth products.
幻燈片 14 突出了我們主要增長產品的貢獻。
In total, these brands generated nearly $3 billion in revenue this quarter, making up 51% of total revenue.
這些品牌本季度總共創造了近 30 億美元的收入,佔總收入的 51%。
On Slide 15, we provide an update on capital allocation.
在幻燈片 15 上,我們提供了資本配置的最新信息。
In Q1 2020, we invested $2.4 billion to drive our future growth through a combination of business development, capital expenditures and after-tax investment in R&D.
2020 年第一季度,我們投資了 24 億美元,通過結合業務發展、資本支出和研發的稅後投資來推動我們的未來增長。
In addition, we returned approximately $1.2 billion to shareholders via dividends and share repurchases.
此外,我們通過股息和股票回購向股東返還了大約 12 億美元。
We remained well capitalized and closed Q1 with approximately $4 billion of cash and investments and the ability to access debt markets at attractive rates.
我們仍然資本充足,第一季度結束時擁有大約 40 億美元的現金和投資,並有能力以有吸引力的利率進入債務市場。
Moving to Slide 16.
轉到幻燈片 16。
You'll find our updated 2020 financial guidance.
您將找到我們更新的 2020 年財務指南。
This is based on our best estimates at this time as we are balancing transparency and insight into the current view of our business with the uncertainty surrounding the extent and duration of the impact of the COVID-19 pandemic.
這是基於我們目前的最佳估計,因為我們正在平衡透明度和對我們當前業務視圖的洞察力與圍繞 COVID-19 大流行影響的程度和持續時間的不確定性。
Key assumptions supporting our updated guidance include: the Q1 stocking benefit largely reverses over the course of 2020; the near-term reduction in new patient prescription peaks in the second quarter in the U.S. and much of Europe; health care activity returns to more normal levels in the second half of this year as doctors resume seeing new patients; price headwinds from the increased utilization of patient affordability programs and changes in segment mix due to increased U.S. unemployment, and enrollment in existing studies as well as the initiation of new clinical trials resumes mid-year; and near-term spending on travel, in-person customer interactions and direct-to-consumer advertising decreases; and investments in digital promotion and support increase.
支持我們更新指導的關鍵假設包括:第一季度的庫存收益在 2020 年期間大幅逆轉;在美國和歐洲大部分地區,新患者處方的近期減少在第二季度達到峰值;隨著醫生恢復接診新患者,醫療保健活動在今年下半年恢復到更正常的水平;由於美國失業率增加,現有研究的註冊以及新臨床試驗的啟動在年中恢復,患者負擔能力計劃的利用率增加和細分市場組合的變化帶來了價格逆風;近期在旅行、面對面客戶互動和直接面向消費者的廣告方面的支出減少;以及對數字推廣和支持的投資增加。
We do believe the reduction in new patient starts will be temporary but will impact our 2020 performance.
我們確實相信新患者開始的減少將是暫時的,但會影響我們 2020 年的表現。
The potential impact from increased unemployment will likely be more muted in the near term, but the impact could be more pronounced in 2021, depending on the shape of an economic recovery and the U.S. government programs to stimulate employment.
失業率上升的潛在影響在短期內可能會更加溫和,但到 2021 年影響可能會更加明顯,這取決於經濟復甦的形式和美國政府刺激就業的計劃。
While the extent and duration of impact from COVID-19 drives the most uncertainty in our outlook, the positive underlying momentum in Q1 in our business augmented by the addition -- the estimated additional revenue benefit from COVID-19-related buying patterns, gives us confidence that the potential downside for the remainder of the year is accommodated within our previously communicated revenue range.
雖然 COVID-19 影響的程度和持續時間是我們前景中最大的不確定性,但我們業務在第一季度的積極潛在勢頭因增加而增強 - 估計與 COVID-19 相關的購買模式帶來的額外收入收益,給了我們相信今年剩餘時間的潛在下行空間在我們之前傳達的收入範圍內。
While there are scenarios that could cause revenue to fall outside either end of our range, we believe the revenue range accommodates most of the uncertainty we see today.
雖然有些情況可能導致收入超出我們範圍的任一端,但我們認為收入範圍可以適應我們今天看到的大部分不確定性。
In addition to the impact of unemployment and the pace of economic recovery described earlier, the main variables we will monitor are the impact on new prescription trends during social distancing periods and the timing of resumption of non-COVID-19 health care activities.
除了前面描述的失業影響和經濟復甦步伐外,我們將監測的主要變量是社會疏遠期間對新處方趨勢的影響以及恢復非 COVID-19 醫療保健活動的時機。
While we currently anticipate the most pronounced impact on new prescriptions to occur in Q2, the headwinds are likely to show up in Q3 and Q4 as inventory levels normalize and the impact of fewer new prescriptions compounds.
雖然我們目前預計對新處方的最顯著影響將出現在第二季度,但隨著庫存水平正常化以及新處方化合物減少的影響,不利因素可能會出現在第三季度和第四季度。
Moving down the income statement.
向下移動損益表。
We're confirming our prior expectations for gross margin as a percent of revenue to be roughly 81% on a non-GAAP basis and 79% on a GAAP basis.
我們確認我們先前對毛利率佔收入的百分比的預期在非 GAAP 基礎上約為 81%,在 GAAP 基礎上為 79%。
We do anticipate higher manufacturing costs associated with the extraordinary measures we are taking to keep our manufacturing workers safe and to keep medicine flowing to patients around the world.
我們確實預計,與我們為確保製造工人的安全和讓藥品流向世界各地的患者而採取的非常措施相關的製造成本會更高。
We expect this to be offset, though, by benefits from higher manufacturing volume.
不過,我們預計這將被更高的製造量所帶來的好處所抵消。
We are maintaining our range for marketing, selling and administrative expenses as savings from reduced travel and decreased promotion are anticipated to be offset by investments in digital capabilities and increased marketing expenses in the second half of the year for key growth products.
我們正在維持我們的營銷、銷售和管理費用範圍,因為減少旅行和減少促銷所節省的費用預計將被今年下半年對關鍵增長產品的數字能力投資和營銷費用增加所抵消。
Our range for research and development expenses is also unchanged as savings from the pause to clinical trial activities are offset by our investments to pursue therapeutic treatments for COVID-19, as Dan described earlier.
正如 Dan 前面所述,我們的研發費用範圍也沒有變化,因為從暫停到臨床試驗活動所節省的資金被我們為 COVID-19 尋求治療的投資所抵消。
Therefore, there's no change to our non-GAAP operating income as a percent of revenue guidance of 31%.
因此,我們的非 GAAP 營業收入佔收入指導的 31% 沒有變化。
We're updating the range of other income and expense to $0 to $150 million of expense, reflecting Q1 gains in our equity portfolio.
我們將其他收入和支出的範圍更新為 0 到 1.5 億美元的支出,反映了我們股票投資組合的第一季度收益。
Obviously, this number had some volatility going forward, and we'll update accordingly.
顯然,這個數字在未來會有一些波動,我們會相應地更新。
Turning to taxes.
轉向稅收。
There's no change to our GAAP and non-GAAP effective tax rate guidance of approximately 15%.
我們的 GAAP 和非 GAAP 有效稅率指導沒有變化,約為 15%。
Earnings per share is now expected to be in the range of $6.70 to $6.90 on a non-GAAP basis.
按非公認會計原則計算,每股收益現在預計在 6.70 美元至 6.90 美元之間。
Our GAAP EPS is expected to be in the range of $6.20 to $6.40.
我們的公認會計原則每股收益預計在 6.20 美元至 6.40 美元之間。
We're increasing the range to reflect the uncertainty of the impact to our business for the remainder of the year.
我們正在擴大範圍以反映今年剩餘時間對我們業務影響的不確定性。
Our performance in the first quarter, net of COVID-19 benefit, highlights the strength of our underlying business fundamentals.
我們在第一季度的業績(扣除 COVID-19 的收益)凸顯了我們基礎業務基礎的實力。
And as Dave mentioned in his introduction, we remain confident in the long-term outlook for our business.
正如戴夫在他的介紹中提到的那樣,我們對我們業務的長期前景仍然充滿信心。
So Dave, I'll turn it back to you for closing remarks.
所以戴夫,我會把它轉回給你的結束語。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Thanks, Josh.
謝謝,喬希。
The COVID-19 global pandemic has impacted us all in unforeseen ways.
COVID-19 全球大流行以不可預見的方式影響了我們所有人。
Although near-term challenges exist, we do remain confident in our long-term outlook for the company and the strength of our fundamentals.
儘管存在短期挑戰,但我們對公司的長期前景和基本面的實力仍然充滿信心。
Times of great crisis can bring out the best in people and in companies, and Lilly will continue to rise to that challenge.
重大危機時期可以激發員工和公司的最佳潛能,禮來將繼續迎接這一挑戰。
While a great deal of uncertainty remains, there are a few certainties to which I would draw your attention.
儘管仍然存在很多不確定性,但我會提請您注意一些確定性。
First, the collective spirit, expertise and commitment of my Lilly colleagues around the world is inspiring.
首先,我在世界各地的禮來同事的集體精神、專業知識和承諾令人鼓舞。
Despite challenging circumstances and disrupted work routines, they have rallied to fulfill our mission of discovering and supplying medicines that make life better for people around the world.
儘管環境充滿挑戰,工作程序被打亂,但他們仍團結一致,完成我們的使命,即發現和提供藥物,讓世界各地的人們生活得更美好。
They are exceptional.
他們很特別。
Second, speed and agility continue to be critical to the success of our business.
其次,速度和敏捷性仍然是我們業務成功的關鍵。
We've moved swiftly, pivoting our focus to join the fight against the COVID-19 pandemic by leveraging our deep scientific capabilities and expertise on both the testing and therapeutic fronts.
我們迅速採取行動,通過利用我們在測試和治療方面的深厚科學能力和專業知識,將重點轉向抗擊 COVID-19 大流行。
And lastly, I've never been more certain of the importance of a healthy and vibrant biopharmaceutical industry.
最後,我從未像現在這樣確定健康和充滿活力的生物製藥行業的重要性。
While it will take time to exit the current situation, we will recover.
雖然退出目前的情況需要時間,但我們會恢復的。
And the pharmaceutical industry will be the primary catalyst, developing new treatments and a vaccine to combat COVID-19, allowing people across the world to return to living their lives more normally and enabling economic activity to grow.
製藥業將成為主要催化劑,開發新的治療方法和疫苗來對抗 COVID-19,讓世界各地的人們恢復更正常的生活,促進經濟活動的增長。
It's clear we are a vital part of any long-term solution for fighting this or any future pandemic.
很明顯,我們是抗擊這次或任何未來流行病的任何長期解決方案的重要組成部分。
This concludes our prepared remarks.
我們準備好的評論到此結束。
And now I'll turn the call over to Kevin to moderate the Q&A session.
現在我將把電話轉給 Kevin 來主持問答環節。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dave.
謝謝,戴夫。
(Operator Instructions)
(操作員說明)
Alan, please provide the instructions for the Q&A session, and then we're ready for the first caller.
Alan,請提供問答環節的說明,然後我們為第一個來電者做好準備。
Operator
Operator
(Operator Instructions) Our first question will come from the line of Terence Flynn with Goldman Sachs.
(操作員說明)我們的第一個問題將來自高盛的 Terence Flynn。
Terence C. Flynn - MD
Terence C. Flynn - MD
Maybe first, I was just wondering, Josh, if you could expand on how the environment changes your approach to capital allocation?
也許首先,我只是想知道,喬希,您是否可以擴展環境如何改變您的資本配置方法?
I know you mentioned maybe less share repurchases in the near term.
我知道你提到短期內可能會減少股票回購。
But on the BD M&A side, do you actually think there could be an increasing number of opportunities?
但在 BD 併購方面,您真的認為機會會越來越多嗎?
And does it change how you think about size?
它會改變你對尺寸的看法嗎?
And then the second I had was just where you stand with regulatory interactions and launch prep for selpercatinib.
然後我所擁有的第二個就是您與監管互動並啟動 selpercatinib 的準備工作。
Just wondering if COVID changes at all your go-to-market strategy?
只是想知道 COVID 是否會改變您的所有上市策略?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Terence.
謝謝,特倫斯。
We'll go to Josh for the first one and then Anne to the question on selpercatinib.
我們先去找 Josh 回答第一個問題,然後是 Anne 回答關於 selpercatinib 的問題。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Terence, thanks.
特倫斯,謝謝。
On capital allocation, we really are sticking to our strategy.
在資本配置方面,我們確實堅持我們的策略。
And as we've outlined, we do see external innovation or business development as a key component of our long-term growth strategy.
正如我們所概述的,我們確實將外部創新或業務發展視為我們長期增長戰略的關鍵組成部分。
But what we're really focused on -- continue to focus on are key opportunities in our therapeutic areas where we can bring in first or best-in-class type of assets into the pipeline.
但我們真正關注的是 - 繼續關注的是我們治療領域的關鍵機會,我們可以將第一類或同類最佳類型的資產引入管道。
We're continuing -- I think that work continues.
我們正在繼續——我認為這項工作仍在繼續。
I haven't seen anything slow down as a function of not being able to travel or work-from-home types of activities.
我沒有看到任何因無法旅行或在家工作類型的活動而放緩的情況。
Certainly, there are smaller biotech companies that may have different views in terms of their cash runway or needs.
當然,有些規模較小的生物技術公司可能對其現金渠道或需求有不同的看法。
And to the extent that, that helps to engender more discussions, we'll take advantage of that.
在某種程度上,這有助於引發更多討論,我們將利用這一點。
I don't think it changes anything in terms of how we think about size.
我認為它不會改變我們對尺寸的看法。
Our business is strong, as I mentioned, and we don't see benefits in large-scale types of acquisitions.
正如我所提到的,我們的業務很強大,我們沒有看到大規模收購的好處。
So we'll continue to focus on the things that we are focused on.
因此,我們將繼續關注我們所關注的事情。
And I think for as long as we're in these kind of social distancing restrictions, I don't see that as impacting our ability to transact.
而且我認為,只要我們處於這種社交距離限制中,我認為這不會影響我們的交易能力。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Anne?
安妮?
Anne E. White - Senior VP & President of Lilly Oncology
Anne E. White - Senior VP & President of Lilly Oncology
Yes.
是的。
Terence, thanks for the question on selpercatinib.
特倫斯,感謝關於 selpercatinib 的問題。
So I'm pleased to share that there's been no delay in the regulatory time line for selpercatinib.
因此,我很高興與大家分享,selpercatinib 的監管時間線沒有延遲。
And the FDA has been extremely collaborative and responsive in working through these challenging times.
在這些充滿挑戰的時期,FDA 一直非常協作和響應迅速。
So we just thank them for the speed and the commitment they've had.
所以我們只是感謝他們的速度和他們的承諾。
They've continued to progress the application.
他們繼續推進申請。
And as you know, we submitted in December.
如您所知,我們是在 12 月提交的。
It's currently under priority review, so we expect to have regulatory action by the PDUFA date in Q3.
它目前正在優先審查中,因此我們預計將在第三季度的 PDUFA 日期之前採取監管行動。
Regarding your questions on launch, it is interesting times, obviously.
關於您在發佈時提出的問題,顯然這是一個有趣的時刻。
And as a company, as Dave shared, we continue to prioritize combating the spread of coronavirus.
正如戴夫所說,作為一家公司,我們將繼續優先考慮抗擊冠狀病毒的傳播。
And we recognize that this is also the case for health care professionals.
我們認識到,這也是醫療保健專業人員的情況。
And we're incredibly aware of the load that they're carrying at this time and need to express our appreciation for all of their efforts on behalf of their patients.
我們非常清楚他們此時所承受的負擔,需要對他們代表患者所做的所有努力表示感謝。
So with that, we also though recognize that selpercatinib has shown striking efficacy and really a very favorable safety profile in treating lung and thyroid cancers with RET fusions or RET mutations.
因此,儘管如此,我們也認識到 selpercatinib 在治療具有 RET 融合或 RET 突變的肺癌和甲狀腺癌方面顯示出驚人的療效和非常有利的安全性。
And so we think it still is very important that patients and physicians are aware that there's a new medicine available and the first to specifically target RET alterations.
因此,我們認為患者和醫生意識到有一種新藥可用並且是第一個專門針對 RET 改變的藥物仍然非常重要。
So what we're doing with launch activities, they will look different, but we're committed to making sure that patients who are good candidates for selpercatinib have access.
因此,我們在啟動活動中所做的事情看起來會有所不同,但我們致力於確保適合 selpercatinib 的患者能夠使用。
So assuming that in person interactions are still on hold when we launch, we're going to focus initially on making sure that we inform customers of the approval and the key efficacy and safety data via e-mail and other digital channels that we have.
因此,假設當我們推出時,面對面的互動仍處於暫停狀態,我們將首先專注於確保我們通過電子郵件和我們擁有的其他數字渠道將批准以及關鍵功效和安全性數據告知客戶。
We're also going to make sure that we're quick to engage in virtual product details when the customer requests those and give them more information.
我們還將確保在客戶提出要求時快速處理虛擬產品詳細信息並為他們提供更多信息。
And then when appropriate, we're also going to make sure that we leverage virtual peer-to-peer programs to provide thought leaders the opportunity to share the data with their colleagues.
然後在適當的時候,我們還將確保我們利用虛擬點對點程序為思想領袖提供與同事共享數據的機會。
And in addition, of course, we'll be sharing the data through a top-tier journal publication as well as in upcoming medical meetings.
此外,當然,我們將通過頂級期刊出版物以及即將召開的醫學會議共享數據。
So we'll make sure that -- the goal here is to make sure that physicians and patients are aware and informed that we have now an incredible new medicine that's specifically targeted for RET.
因此,我們將確保——這裡的目標是確保醫生和患者知道並告知我們現在有一種令人難以置信的新藥,專門針對 RET。
And it's just been an incredible partnership with Loxo and the Loxo and Lilly teams.
與 Loxo 以及 Loxo 和 Lilly 團隊建立了令人難以置信的合作夥伴關係。
If you think about it, this medicine started Phase I. First patient dosed in May of 2017, and we're looking at approval here in 2020.
如果您考慮一下,該藥已開始 I 期。2017 年 5 月首次患者給藥,我們正在等待 2020 年的批准。
So it's remarkable.
所以很了不起。
And our thanks really goes to the FDA for the speed at which they're moving through the review.
我們真的要感謝 FDA 的審查速度。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Anne.
謝謝,安妮。
Terence, thanks for your questions.
特倫斯,謝謝你的提問。
Operator
Operator
Our next question will come from the line -- one moment, please.
我們的下一個問題將來自該線路- 請稍等。
I'm having some equipment difficulty, and I seem to have lost my queue.
我遇到了一些設備問題,而且我似乎失去了隊列。
(technical difficulty)
(技術難度)
Operator
Operator
(Operator Instructions) We will move next to the line of Chris Schott with JPMorgan.
(操作員說明)我們將與摩根大通一起移動到 Chris Schott 的旁邊。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Just my 2 questions.
只是我的2個問題。
First, on disruption to near-term prescription.
首先,關於近期處方的中斷。
You mentioned diabetes as an area less impacted relative to areas like pain and immunology.
你提到糖尿病是一個相對於疼痛和免疫學等領域影響較小的領域。
But I did have a specific question on Trulicity.
但我確實有一個關於 Trulicity 的具體問題。
I guess when I think about that product and the GLP-1 category in general, we've been seeing very healthy growth here.
我想當我考慮該產品和 GLP-1 類別時,我們已經看到了非常健康的增長。
We've seen significant new patient starts.
我們已經看到重要的新患者開始。
Is this a product and a market maybe more broadly that you anticipate could see a slowdown as we go through 2Q as the impact of some of the reduced physician visits start to build?
隨著一些醫生就診次數減少的影響開始顯現,隨著我們進入第二季度,這是否是一種產品和一個市場可能會出現更廣泛的放緩?
And then my second question was on payer mix over time.
然後我的第二個問題是隨著時間的推移付款人組合。
Can you just help us frame the magnitude of impact you could see to net price in the U.S. from adverse payer mix as we look out over, say, the next year or so?
當我們展望明年左右時,您能否幫助我們確定不利的付款人組合對美國淨價格的影響程度?
I guess specifically, is this something that could cause price to meaningfully deviate from this low single-digit price erosion we're seeing?
我想具體來說,這是否會導致價格顯著偏離我們所看到的低個位數價格侵蝕?
So could that become more like a mid- to high single-digit erosion?
那麼,這會變得更像是中高個位數的侵蝕嗎?
Or are you thinking about a more modest impact than that?
或者您是否正在考慮比這更溫和的影響?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Chris.
謝謝,克里斯。
We'll go to Mike Mason for the question on Trulicity; then Josh, the question on payer mix.
關於 Trulicity 的問題,我們會去找 Mike Mason;然後是 Josh,關於付款人組合的問題。
Michael B. Mason - Senior VP & President of Lilly Diabetes
Michael B. Mason - Senior VP & President of Lilly Diabetes
Okay.
好的。
On Trulicity, it's difficult to predict long-term impact of the COVID-19 crisis given the uncertainty on the length and the impact on economy and patient visits.
在 Trulicity 上,鑑於持續時間的不確定性以及對經濟和患者就診的影響,很難預測 COVID-19 危機的長期影響。
And also, it's unclear how patients who live with diabetes who are at greater risk or complications from COVID-19 will -- will that change the compliance that they have with the medication and increase that.
而且,目前尚不清楚患有 COVID-19 風險或併發症的糖尿病患者將如何改變他們對藥物的依從性並增加這種依從性。
But what I can tell you is a little over a month into the crisis that the GLP market and Trulicity TRx volume remains strong.
但我可以告訴你的是,危機已經過去了一個多月,GLP 市場和 Trulicity TRx 交易量依然強勁。
It's currently at 30%.
目前為 30%。
And so we haven't seen the impact at the TRx level yet.
因此,我們還沒有看到 TRx 級別的影響。
We have seen an impact on NTS and NBRx volume kind of post-COVID both for Trulicity and the GLP market.
對於 Trulicity 和 GLP 市場,我們已經看到了對 NTS 和 NBRx 後 COVID 交易量類型的影響。
Josh had shared that the overall pharma market had seen a decline of 42% in NBRx.
喬希分享說,整個製藥市場的 NBRx 下降了 42%。
What we're seeing in the GLP market is a 30% decline for NBRx.
我們在 GLP 市場看到的是 NBRx 下降了 30%。
Now we haven't seen that manifest itself in the TRx volume yet.
現在我們還沒有在 TRx 卷中看到這一點。
If you take a look at the NBRx and -- for Trulicity, it's only 5.6% of the TRx rate, which is a really relatively low turnover for the marketplace.
如果你看一下 NBRx,對於 Trulicity,它只有 TRx 率的 5.6%,這對於市場來說是一個相對較低的營業額。
So we think that Trulicity relative to other products, other therapeutic areas will have kind of a slower impact from the COVID situation.
因此,我們認為 Trulicity 相對於其他產品、其他治療領域將受到 COVID 情況的較慢影響。
But again, it's hard to predict as we have uncertainty on the length and the impact on the economy and patient visits.
但同樣,很難預測,因為我們對長度以及對經濟和患者就診的影響存在不確定性。
What we can say is that we're very confident in Trulicity's strong fundamentals.
我們可以說的是,我們對 Trulicity 強大的基本面非常有信心。
We saw 32% volume growth in Q1 and 40% revenue growth in Q1.
我們看到第一季度的銷量增長了 32%,第一季度的收入增長了 40%。
So we're very confident in the very strong fundamentals of Trulicity.
因此,我們對 Trulicity 非常強大的基礎非常有信心。
So Chris, thanks for your question.
所以克里斯,謝謝你的問題。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Mike.
謝謝,邁克。
Josh?
喬什?
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Thanks, Chris.
謝謝,克里斯。
On your question on what could happen to net price going forward, given what we're seeing in the U.S. with the economy, first, I think, it's too early to make too many predictions.
關於你關於未來淨價格會發生什麼的問題,鑑於我們在美國看到的經濟情況,首先,我認為,現在做出太多預測還為時過早。
There's a lot to still see.
還有很多東西要看。
And as you highlighted in your question, we've already assumed that we're going to see negative net prices in the U.S. for -- between now and 2025, that's already in our current guidance.
正如您在問題中強調的那樣,我們已經假設從現在到 2025 年,我們將看到美國的負淨價,這已經在我們目前的指導中。
So I would see whatever happens here as probably a moderate impact on that.
所以我認為這裡發生的任何事情都可能對此產生適度的影響。
I think what we have to keep in mind, first, for Lilly's portfolio, we're spread across across multiple payer segments.
我認為我們必須牢記,首先,對於禮來的投資組合,我們分佈在多個付款人領域。
Certainly, in general, a move from a well-insured commercial patient to Medicaid is a net negative.
當然,一般來說,從投保良好的商業患者到醫療補助計劃是一個淨負面因素。
But many of the commercial patients, it is my assumption, who are losing -- in the first wave losing employment, they may not be in great commercial plans to begin with, their exchanges and other things.
但我的假設是,許多商業患者正在失去——在第一波失業中,他們可能一開始就沒有很好的商業計劃,他們的交流和其他事情。
So there's a lot to still see what happens here.
所以還有很多事情要看這裡發生了什麼。
Our view is we'll ensure that the patients who are losing insurance have access to our medications and programs.
我們的觀點是,我們將確保失去保險的患者能夠獲得我們的藥物和計劃。
We -- as Dave mentioned, announced a $35 change to our diabetes program.
正如戴夫所說,我們宣布對我們的糖尿病計劃進行 35 美元的更改。
So we're looking at everything we can do to ensure that people can stay on our medications and have access to them and believe that some of these impacts will be temporary.
因此,我們正在考慮我們能做的一切,以確保人們可以繼續服用我們的藥物並獲得它們,並相信其中一些影響將是暫時的。
And then we'll have a much better sense by the end of the year on what 2021 looks like.
然後到今年年底,我們將對 2021 年的情況有一個更好的認識。
But I'd say overall, our expectation is this continues to trend and net price declines but not a fundamental change to how we're thinking about the business.
但我想說總體而言,我們的預期是這將繼續趨勢和淨價格下降,但不會對我們對業務的看法發生根本性變化。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Chris, thanks for your questions.
克里斯,謝謝你的提問。
Operator
Operator
We will move next to the line of Andrew Baum with Citi.
我們將與花旗一起移動到 Andrew Baum 的旁邊。
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
Same topic.
同一個話題。
You have a high exposure relative to your peers to the commercial book.
與同行相比,您對商業書籍的曝光率很高。
For your full year guidance, could you help us on what kind of U.S. unemployment rates you're assuming as well as some magnitude of the volume loss and potential Medicaid expansion?
對於您的全年指導,您能否幫助我們了解您假設的美國失業率以及一定程度的數量損失和潛在的醫療補助計劃擴張?
Anything you can say about the risk for 2021?
關於 2021 年的風險,您有什麼想說的嗎?
And then separately, on Olumiant baricitinib for COVID-19, I'm just trying to understand which patient population you're targeting.
然後另外,關於 COVID-19 的 Oluminant baricitinib,我只是想了解您的目標人群。
The literature talks both a potential antiviral effect as well as an anti-inflammatory effect, which would suggest potentially 2 different patient populations, the earlier then respiratory distress.
文獻討論了潛在的抗病毒作用和抗炎作用,這表明可能存在 2 個不同的患者群體,即較早的呼吸窘迫。
Where are you going here with the clinical trial?
你要去哪裡進行臨床試驗?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Andrew.
謝謝,安德魯。
We'll go to Josh for the first question and then Dan on bari and COVID-19.
第一個問題是 Josh,然後是關於 bari 和 COVID-19 的 Dan。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Thank you, Andrew.
謝謝你,安德魯。
I think as it relates to 2020, our sales guidance range on the -- I described sort of the factors we're looking at.
我認為,由於它與 2020 年有關,我們的銷售指導範圍 - 我描述了我們正在考慮的一些因素。
And I'd say if we're on the lower end of that sales range, we do include in our thinking there some incremental impact from pricing.
而且我想說,如果我們處於該銷售範圍的低端,我們確實在我們的想法中考慮了定價的一些增量影響。
Again, I think it's probably be pretty muted this year.
再說一次,我認為今年可能會很安靜。
And then I think we'll just have to look and see what next year looks like.
然後我認為我們只需要看看明年會是什麼樣子。
And I think it's not just absolute levels of unemployment, it's what programs are in place to bridge the gap and otherwise.
而且我認為這不僅僅是失業率的絕對水平,還有縮小差距的計劃等等。
So this year, again, I think our range -- given the strong position we're starting from in Q1, our range accommodates potential incremental pricing impacts for potentially short-term moves to an insurance or Medicaid.
所以今年,我再次認為我們的範圍 - 鑑於我們從第一季度開始的強勢地位,我們的範圍可以適應潛在的短期轉向保險或醫療補助的潛在增量定價影響。
But I think at this point, it's a little early to have a real lot of specifics around this one.
但我認為在這一點上,圍繞這個有很多細節還為時過早。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Dan?
擔?
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Thanks, Andrew, for the question on baricitinib and mechanism of action and potential on COVID-19.
謝謝 Andrew,關於巴瑞克替尼的問題以及 COVID-19 的作用機制和潛力。
You're right in your comments about a potential for a dual mechanism of action for baricitinib.
您對巴瑞克替尼潛在的雙重作用機制的評論是正確的。
The -- I think first publication on the potential role of baricitinib in COVID-19 came from a group called Benevolent AI, where they modeled out that the effects, both on viral entry and on inflammatory response could be beneficial in this disease.
- 我認為關於 baricitinib 在 COVID-19 中的潛在作用的第一份出版物來自一個名為 Benevolent AI 的小組,他們在該小組中模擬了對病毒進入和炎症反應的影響可能對這種疾病有益。
The trial that we discussed that is the Adaptive COVID-19 trial with NIAID is in hospitalized patients.
我們討論的 NIAID 適應性 COVID-19 試驗是在住院患者中進行的。
So it's rather later in the disease progression.
所以它在疾病進展中相當晚。
And the design of the trial is primarily to look at the effects of baricitinib on that inflammatory cascade.
該試驗的設計主要是研究巴瑞克替尼對炎症級聯反應的影響。
It's notable that, that trial currently is conceived of as a factorial design with remdesivir.
值得注意的是,該試驗目前被認為是瑞德西韋的析因設計。
Of course, in addition to looking at the clinical outcomes of these patients who have viral load and other factors will also be evaluated.
當然,除了看這些有病毒載量和其他因素的患者的臨床結果外,還將進行評估。
I think if we see success there, that could give us confidence to go earlier in the disease course.
我認為,如果我們在那裡看到成功,那可能會讓我們有信心在疾病過程中更早地走下去。
But given sort of the mixed mechanism of action here, right now, we're looking at those hospitalized patients.
但是考慮到這裡的混合作用機制,現在,我們正在研究那些住院患者。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dan.
謝謝,丹。
Andrew, thanks for your questions.
安德魯,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will come from Dave Risinger with Morgan Stanley.
這將來自摩根士丹利的戴夫·瑞辛格。
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
So I have 2 questions.
所以我有2個問題。
First, in the event that baricitinib and/or the Ang2 succeed in June, what are the next steps?
首先,如果巴瑞替尼和/或 Ang2 在 6 月取得成功,下一步是什麼?
Would you be filing for approval at that time?
你會在那個時候申請批准嗎?
And then with respect to the Ang2, could you just discuss the manufacturing capacity and the amount of volume you could produce later this year?
然後關於 Ang2,你能談談今年晚些時候的製造能力和產量嗎?
And then second, with respect to clinical trials, when do you expect to restart enrollment in the majority of your trials?
其次,關於臨床試驗,您預計何時會在您的大多數試驗中重新開始註冊?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks.
謝謝。
Dave, we'll go to Dan for both of those.
戴夫,這兩個我們都去找丹。
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Yes.
是的。
Thanks, Dave.
謝謝,戴夫。
So starting out with the expectations for what if any of our molecules are successful in COVID-19, baricitinib is probably the most straightforward to answer.
因此,如果我們的任何分子在 COVID-19 中取得成功,那麼從對我們的任何分子的期望開始,巴瑞替尼可能是最直接的答案。
It's a small molecule that can be produced at large capacity, and it's already approved in geographies around the world for rheumatoid arthritis.
它是一種可以大容量生產的小分子,它已經在世界各地被批准用於治療類風濕性關節炎。
So depending on the quality of the data and the benefit/risk that we see in COVID-19 patients, you could expect that could potentially move very, very quickly if it's successful.
因此,根據我們在 COVID-19 患者中看到的數據質量和收益/風險,您可以預期,如果它成功,它可能會非常非常迅速地發生變化。
Ang2 is sort of the opposite end of the spectrum.
Ang2 是光譜的另一端。
This is an investigational monoclonal antibody.
這是一種研究性單克隆抗體。
Production is more constrained, and lead times are longer.
生產受到更多限制,交貨時間更長。
And this is a Phase II type trial.
這是一個II期類型的試驗。
I think, though, the one that we're most focused on, which you didn't directly ask about in your question, is the neutralizing antibodies against COVID-19.
不過,我認為,我們最關注的(您在問題中沒有直接詢問的)是針對 COVID-19 的中和抗體。
I think that's where we see a relatively high probability of technical success, given success with neutralizing antibodies against other viruses and also given what we've seen preclinically with our project.
我認為這就是我們看到技術成功的可能性相對較高的地方,考慮到中和抗體對其他病毒的成功,以及我們在臨床前看到的項目。
And that's also one where you can imagine a broad treatment paradigm.
這也是您可以想像一種廣泛的治療範式的地方。
Antibodies like this are likely not only to work in sick patients but could potentially have a prophylactic use, which then sort of demands large quantities.
像這樣的抗體可能不僅對病人有效,而且可能具有預防用途,因此需要大量的抗體。
I think in all these programs, you just also note that these aren't chronic therapies.
我認為在所有這些項目中,你也注意到這些不是慢性療法。
They're one-time use or a short period of time in the case of baricitinib.
對於巴瑞替尼,它們是一次性使用或短期使用。
But still, I think for the antibody, we're working very diligently to expand our manufacturing capacity that would be ready to deploy, both internally and with partnerships, if the neutralizing antibodies are successful.
但是,我仍然認為對於抗體,我們正在非常努力地擴大我們的製造能力,如果中和抗體成功,我們將準備好在內部和合作夥伴中部署這些能力。
We're making those investments in advance.
我們正在提前進行這些投資。
I mentioned we started GMP manufacturing already at our facilities to support the clinical trials, and we're prepared to scale quite rapidly if we see a positive signal with the neutralizing antibody.
我提到我們已經在我們的設施中開始 GMP 生產以支持臨床試驗,如果我們看到中和抗體的積極信號,我們準備迅速擴大規模。
Your second question was on clinical trial restart time lines.
您的第二個問題是關於臨床試驗重新開始的時間線。
I think it's important to think about the context for why we stopped enrolling new patients and starting new clinical trials.
我認為重要的是要考慮為什麼我們停止招募新患者並開始新的臨床試驗的背景。
It wasn't so much a problem with our ability to maintain the clinical trials.
我們維持臨床試驗的能力並沒有太大問題。
In fact, I'm quite confident, even more confident today than I would have been a month ago, in our ability to meet all of our sponsor obligations, our ability to deliver drug to sites or even directly to patients where it's needed, to measure outcomes either at the sites or by other means directly with patients.
事實上,我非常有信心,甚至比一個月前更有信心,我們有能力履行我們所有的讚助商義務,我們有能力將藥物運送到需要的地點,甚至直接運送給需要的患者,在現場或通過其他方式直接與患者測量結果。
So I'm really confident in our ability to carry out the trials.
所以我對我們進行試驗的能力非常有信心。
It's a desire to relieve the sites and the hospitals of the burden of running clinical trials.
希望減輕現場和醫院進行臨床試驗的負擔。
So we're watching our clinical trial sites carefully.
因此,我們正在仔細觀察我們的臨床試驗地點。
Many of them are already starting to ask the same question you are when they can restart.
他們中的許多人已經開始問您何時可以重新啟動的相同問題。
We'll make decisions along with them based on the burden of COVID-19 that they're having and how much time and attention they can devote to clinical trials.
我們將根據他們承擔的 COVID-19 負擔以及他們可以投入多少時間和精力進行臨床試驗,與他們一起做出決定。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dan.
謝謝,丹。
Dave, thanks for your questions.
戴夫,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
This is Seamus Fernandez with Guggenheim.
這是古根海姆的 Seamus Fernandez。
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
A couple here.
這裡有一對。
HMA is a consulting group that estimates the sort of medical -- Medicaid enrollment increases.
HMA 是一個諮詢小組,它估計醫療類型——醫療補助的註冊人數會增加。
So I guess, I'm just hoping that you guys could put a little bit more granularity around your estimates for expectations for Medicaid enrollment.
所以我想,我只是希望你們可以更詳細地估計您對醫療補助註冊的預期。
This group estimates that Medicaid enrollment could increase by 11 million to 23 million.
該小組估計,醫療補助註冊人數可能會增加 1100 萬至 2300 萬。
Uninsured could increase by 10 million to 11 million.
未投保的人數可能增加 1000 萬至 1100 萬。
And I just -- maybe if you can just help us put a little context around the percent of volume -- of Lilly's volume that flows into Medicaid currently versus the percent of sales that flows into Medicaid currently.
我只是 - 也許如果你能幫助我們圍繞體積百分比提供一些背景信息 - 禮來公司目前流入 Medicaid 的數量與目前流入 Medicaid 的銷售額百分比。
Can you just, I think, help us understand a little bit of the context in that regard?
我想,你能幫我們了解一下這方面的背景嗎?
And then the second question for Dan.
然後是丹的第二個問題。
Dan, I think we were expecting the Phase II Alzheimer's data in the second half of this year for the N3pG antibody.
丹,我認為我們期待今年下半年的第二階段阿爾茨海默病數據,用於 N3pG 抗體。
Could you just update us on that and how that's progressing?
你能告訴我們最新情況以及進展如何嗎?
Is that still expected in the second half of this year?
今年下半年還會這樣嗎?
Or should we anticipate that in sort of a 2021 time frame?
還是我們應該在 2021 年的時間範圍內預測到這一點?
Just an update there would be great.
只要有更新就會很棒。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Seamus.
謝謝,西莫。
We'll go to Josh for the first question and then Dan for your question on donanemab readout.
我們將向 Josh 提出第一個問題,然後向 Dan 提出關於 donanemab 讀數的問題。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Sure.
當然。
Thanks, Seamus.
謝謝,西莫。
In terms of -- across our entire portfolio, in the U.S., about 10% of our volume is Medicaid right now; about 40% is commercial insurance; 20%, Part D; and then the rest is Part B or hospital-based or uninsured or other types of volumes.
就我們整個投資組合而言,在美國,我們目前約有 10% 的交易量是醫療補助;約40%是商業保險; 20%,D 部分;然後剩下的是 B 部分或基於醫院或無保險或其他類型的捲。
As we talked about before, I think the biggest sort of challenge would be a really well-insured commercial patient moving to Medicaid.
正如我們之前談到的,我認為最大的挑戰將是一個真正有保險的商業患者轉移到醫療補助計劃。
There are a lot of steps in between those things happening.
在這些事情發生之間有很多步驟。
As I mentioned in a prior question, we are anticipating in our sales guidance for 2020 that we could see some net impact as a function of that.
正如我在之前的問題中提到的,我們預計在 2020 年的銷售指導中,我們可以看到一些淨影響。
But again, I would say it's -- and we've looked at all those estimates and in terms of what the long-term look could be.
但同樣,我會說它是 - 我們已經查看了所有這些估計以及長期外觀可能是什麼。
And we'll provide more updates on that for 2021 when we have a better sense.
當我們有更好的感覺時,我們將在 2021 年提供更多更新。
But again, I'd say that our sales guidance right now does accommodate the fact that we may see some near-term moves to increased Medicaid or increased uninsured.
但是,我要再說一遍,我們現在的銷售指導確實適應了這樣一個事實,即我們可能會看到一些近期舉措增加醫療補助或增加無保險。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Dan?
擔?
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Sure.
當然。
Thanks, Seamus, for the question on our Alzheimer's Phase II portfolio.
感謝 Seamus 提出關於我們的阿爾茨海默氏症 II 期產品組合的問題。
You asked specifically about donanemab, our anti-N3pG A beta antibody.
您特別詢問了我們的抗 N3pGA β 抗體 donanemab。
This is a really robust plaque-clearing antibody.
這是一種非常強大的斑塊清除抗體。
We know it can clear plaques to quite a great extent and quite quickly as well.
我們知道它可以在很大程度上清除斑塊,而且速度也很快。
It's a 18-month Phase II study designed to demonstrate efficacy in a relatively large and homogenous population of Alzheimer's patients.
這是一項為期 18 個月的 II 期研究,旨在證明在相對較大且同質的阿爾茨海默氏症患者群體中的療效。
This study is fully enrolled.
這項研究已完全註冊。
It's proceeding along the previously communicated timelines, which means that the last patient visit will be in the end of this year, as you said.
它正在按照之前傳達的時間表進行,這意味著最後一次患者訪問將在今年年底,如你所說。
And most likely, then we'll have data to talk about shortly after that, although probably in January rather than in December.
最有可能的是,在那之後不久我們就會有數據要討論,儘管可能是在一月份而不是十二月份。
But no changes to our timelines on that trial.
但是我們在那次審判的時間表沒有變化。
Similarly, the tau antibody as well as our symptomatic D1 PAM, those are all Phase II studies designed for efficacy.
同樣,tau 抗體以及我們有症狀的 D1 PAM,這些都是為療效而設計的 II 期研究。
Similarly, fully enrolled and moving along the previously communicated timeline.
同樣,完全註冊並沿著先前傳達的時間表移動。
So no change in the Alzheimer's portfolio.
因此,阿爾茨海默氏症的投資組合沒有變化。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dan.
謝謝,丹。
Seamus, thanks for your questions.
Seamus,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will be Steve Scala from Cowen.
那將是來自 Cowen 的 Steve Scala。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
It was mentioned that most clinical programs are paused for new starts.
有人提到,大多數臨床項目都暫停了新的開始。
A couple of questions related to this.
與此相關的幾個問題。
First, I realize that every trial is different.
首先,我意識到每次試驗都是不同的。
But generally speaking, how long will pause have to last to impact the long-term outlook for Lilly's sales visions, say, through 2025?
但一般來說,暫停將持續多長時間才能影響禮來公司銷售願景的長期前景,比如到 2025 年?
And then second, according to clinicaltrials.gov, only 5 of 155 Lilly trials that are actively recruiting have had recruitment status changed in the last 5 weeks.
其次,根據 Clinicaltrials.gov 的數據,在過去 5 週內,積極招募的 155 項禮來試驗中只有 5 項的招募狀態發生了變化。
Just wondering about this relative to what you said and what the release said.
只是想知道這與您所說的和新聞稿所說的有關。
I believe companies are obligated to reflect any changes within 30 days.
我相信公司有義務在 30 天內反映任何變化。
So I'm just curious why really no changes have been reflected.
所以我只是好奇為什麼真的沒有反映任何變化。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Steve.
謝謝,史蒂夫。
We'll go to Dan for both of those questions.
對於這兩個問題,我們都會去找丹。
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Okay.
好的。
Thanks, Steve, for those questions.
謝謝,史蒂夫,這些問題。
So the first question was just about like how long does the delay in new enrollment have to be before it starts to impact our long-term financials.
所以第一個問題是關於新入學延遲多久才會開始影響我們的長期財務狀況。
Look, I think you know very well that clinical trial timelines and enrollment timelines are often estimates.
聽著,我想你很清楚臨床試驗時間表和入組時間表通常是估計的。
We give those rounded usually to the 0.5 year or sometimes just calendar year.
我們通常將這些四捨五入到 0.5 年或有時只是日曆年。
So for now, you can think of these as a worst-case scenario being a day-to-day delay.
因此,就目前而言,您可以將這些視為最壞的情況,即日常延遲。
So for every day that were paused enrollment, it's a day delay to when we get the data.
因此,對於暫停註冊的每一天,我們獲取數據的時間都會延遲一天。
Now our ambition is to beat that.
現在我們的目標是打敗它。
And there's a couple of reasons why we think we can do that.
我們認為我們可以做到這一點有幾個原因。
There's sort of latent demand to be in these clinical trials that's accumulating.
在這些正在積累的臨床試驗中存在某種潛在的需求。
So when we put the switch again to allow enrollment, we think we'll see a bolus of patients and be able to make up some lost time on enrollment.
因此,當我們再次切換以允許註冊時,我們認為我們會看到大量患者,並且能夠彌補註冊時損失的一些時間。
That's one of the reasons.
這也是原因之一。
Another reason why we can even make up some time and be better than day by day is the fact that we can stagger our enrollment in different geographies.
我們甚至可以抽出一些時間並一天比一天更好的另一個原因是,我們可以錯開不同地區的入學時間。
Not everywhere in the world is similarly affected by COVID-19.
並非世界上任何地方都同樣受到 COVID-19 的影響。
So while our comments on pausing enrollment might apply to the majority of our geographies, there could also be certain countries where we continue to enroll or even shift enrollment more to those countries.
因此,雖然我們關於暫停招生的評論可能適用於我們的大多數地區,但我們也可能會繼續在某些國家/地區招生,甚至將招生更多地轉移到這些國家/地區。
As for the clinicaltrials.gov updating, you're right that there's a time lag in that update.
至於臨床試驗.gov 更新,您說得對,該更新存在時間滯後。
There's also a time lag really in stopping enrollment because you can imagine that although we say no new enrollment, there are patients who could be part of the way through screening.
停止登記也確實存在時間滯後,因為您可以想像,儘管我們說沒有新的登記,但有些患者可能會參與篩查。
And on a case-by-case, trial-by-trial, geography-by-geography basis, we often allow those patients who are already undergoing study procedures to continue those procedures and enroll in the trial.
在逐案、逐個試驗、逐個地區的基礎上,我們經常允許那些已經在接受研究程序的患者繼續這些程序並參加試驗。
So it takes a little bit of time for all this to trickle through the system.
因此,所有這些都需要一點時間才能在系統中傳播。
But I am, as I said earlier, looking forward to the day when we can turn these back on when the hospitals and clinical trial sites have gotten beyond the burden of treating COVID-19 patients.
但是,正如我之前所說,我期待著有一天,當醫院和臨床試驗場所已經擺脫了治療 COVID-19 患者的負擔時,我們可以重新啟用這些功能。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dan.
謝謝,丹。
Thanks, Steve, for your questions.
謝謝史蒂夫,你的問題。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will be in Navin Jacob with UBS.
那將在瑞銀的納文雅各布。
Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic
Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic
Just on Trulicity, if I may, and sorry to beat a dead horse here, but want to understand, relative to the negative 5% price pressure that you had guided to in the U.S., how we should be thinking about that now?
如果可以的話,就在 Trulicity 上,很抱歉在這裡打死馬,但想了解,相對於您在美國指導的 5% 的負價格壓力,我們現在應該如何考慮?
And related to that, is -- I know you've spoken about -- or you've spoken to insulins being barely profitable in the Medicaid channel.
與此相關的是——我知道你已經談到了——或者你已經談到胰島素在醫療補助渠道中幾乎沒有盈利。
Is that true for Trulicity as well?
Trulicity 也是這樣嗎?
I'm assuming it's not as onerous as it is for insulins if that switch were to happen.
我假設如果發生這種轉變,它不會像胰島素那樣繁重。
But just any kind of color would be helpful with regards to Trulicity.
但是任何一種顏色都會對 Trulicity 有所幫助。
And then just a quick question, if I may, on Taltz.
然後只是一個關於 Taltz 的簡短問題,如果可以的話。
Looks quite strong.
看起來相當強大。
You also mentioned changes in rebates and discounts.
您還提到了折扣和折扣的變化。
Any kind of color around pricing for Taltz as well would be helpful.
圍繞 Taltz 定價的任何顏色都會有所幫助。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Navin.
謝謝,納文。
We'll go to Josh for both of these price-related questions on Trulicity and Taltz.
我們將向 Josh 詢問有關 Trulicity 和 Taltz 的這兩個與價格相關的問題。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Thanks, Navin.
謝謝,納文。
First, our outlook at the beginning of the year for U.S. price was net declines in the low single digits.
首先,我們年初對美國價格的展望是低個位數的淨跌幅。
And as I mentioned, in the range that we're looking at now, I think we're still in the low single digits.
正如我所提到的,在我們現在看到的範圍內,我認為我們仍然處於低個位數。
But that could add -- in the more pessimistic case, maybe that adds 1 point or something, but it's still in the same range.
但這可能會增加 - 在更悲觀的情況下,可能會增加 1 分或其他東西,但它仍在同一範圍內。
To your question specifically about products, what we've said is insulins are not profitable in Medicaid.
對於您關於產品的具體問題,我們所說的胰島素在醫療補助計劃中是無利可圖的。
We pay, in effect, 100% rebates for patients who are on mealtime insulins in Medicaid.
實際上,我們為在 Medicaid 中使用餐時胰島素的患者支付 100% 的回扣。
So that's the place where you see a real challenge, I think, to the extent that patients are moving from commercial insurance to Medicaid.
因此,我認為,這就是您看到真正挑戰的地方,即患者正在從商業保險轉向醫療補助。
Trulicity, it's less of an issue.
真實性,這不是一個問題。
It's still net positive.
它仍然是淨積極的。
But Medicaid, just in general, is a lower-price segment than commercial plans.
但總的來說,醫療補助是比商業計劃價格更低的部分。
But it wouldn't be as big of a move as it would be for our commercially insured mealtime insulin patients.
但這不會像我們商業保險的用餐時間胰島素患者那樣大。
On [Taltz] (corrected by company after the call), I think we've highlighted through the last few years that [Taltz] (corrected by company after the call) access is not as strong as it is for the rest of our portfolio.
關於 [Taltz](在電話會議後由公司更正),我認為我們在過去幾年中一直強調 [Taltz](在電話會議後由公司更正)訪問權限不如我們的其他投資組合強大.
And what we have -- what we do in many cases is [Taltz] (corrected by company after the call) patients have to step through various PAs or restrictions in their plans.
而我們所擁有的——在許多情況下,我們所做的是 [Taltz](在電話會議後由公司糾正)患者必須在他們的計劃中逐步完成各種 PA 或限制。
We make estimates on our utilization on how things are going to transpire there.
我們對我們的使用情況進行估計,以了解事情將如何發展。
What we found in Q1 is we were actually getting more net price for a segment of our patients than we had estimated.
我們在第一季度發現的是,我們為一部分患者獲得的淨價格實際上比我們估計的要高。
So we've got a little bit of a benefit there.
所以我們在那裡得到了一點好處。
I think for the year, we're still sort of assuming the same that we maintain the kind of access that we have now at relatively constant prices.
我認為今年,我們仍然假設我們以相對恆定的價格保持我們現在擁有的那種訪問權限。
And you'll see these ups and downs.
你會看到這些起伏。
And it's a little bit challenging in Taltz for the reason, as I mentioned.
正如我所提到的,出於原因,在 Taltz 中這有點挑戰性。
You'll see sort of the quarterly ups and downs, but the underlying trend that we see is pretty stable pricing, pretty stable access.
你會看到某種季度的起伏,但我們看到的基本趨勢是相當穩定的定價,相當穩定的訪問。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Navin, thanks for your questions.
納文,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will be Geoff Meacham with Bank of America.
那將是美國銀行的 Geoff Meacham。
One moment, please.
稍等一會兒。
Mr. Meacham, we seem to have lost your line here.
米查姆先生,我們似乎在這裡失去了您的台詞。
(Operator Instructions)
(操作員說明)
Next question will be from Umer Raffat with Evercore.
下一個問題來自於 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
There's been some concern about GIP safety after European paper.
在歐洲論文發表後,人們對 GIP 的安全性有些擔憂。
And I just thought it will be helpful if you could speak to the blinded CV event rate you're seeing across your Phase III program and whether it's in line with what you would have expected.
我只是認為,如果您能說出您在第三階段計劃中看到的盲目 CV 事件率以及它是否符合您的預期,這將是有幫助的。
And secondly, I know, Josh, you've gotten only 25 questions on it, so let me just ask the 26th one.
其次,我知道,喬希,你只得到了 25 個問題,所以讓我問第 26 個。
You mentioned pretty stable pricing in the diabetes business.
您提到糖尿病業務的定價相當穩定。
Can you speak to whether patients in high-deductible private plans still produce the same net price for Lilly as those in Medicaid?
您能否談談高免賠額私人計劃中的患者是否仍然為禮來(Lilly)產生與醫療補助計劃中相同的淨價格?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks.
謝謝。
We'll -- thanks, Umer.
我們將——謝謝,Umer。
We'll go to Dan around GIP safety and then Josh for pricing.
我們將圍繞 GIP 安全性向 Dan 諮詢,然後向 Josh 諮詢定價。
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Yes.
是的。
Thanks, Umer, for the question.
謝謝 Umer 的提問。
Surely, you're referring to sort of a small epidemiological study that looked at a risk of GIP polymorphisms.
當然,您指的是一項小型流行病學研究,該研究著眼於 GIP 多態性的風險。
I don't think that's directly applicable to what we're seeing with tirzepatide.
我不認為這直接適用於我們在 tirzepatide 上看到的情況。
Here, we're studying this in a population that has diabetes.
在這裡,我們正在一個患有糖尿病的人群中進行研究。
And we know from our Phase II trials that the physiological effects of tirzepatide, which obviously is combined GIP and GLP, are quite beneficial.
我們從我們的 II 期試驗中了解到,顯然結合了 GIP 和 GLP 的 tirzepatide 的生理作用是非常有益的。
And they look like they would have a strong effect on improving cardiovascular outcomes.
他們看起來對改善心血管結果有很大的影響。
So we're super confident about that.
所以我們對此非常有信心。
In terms of the blinded event rates in our ongoing studies, that's not something that we disclose or talk about.
就我們正在進行的研究中的盲事件率而言,這不是我們披露或談論的事情。
But certainly, though, the rate of those events is the rate-limiting factor in our submission.
但可以肯定的是,這些事件的發生率是我們提交的速率限制因素。
So that's the long tail on our submission is waiting to get enough events to discharge any cardiovascular safety risk so we can submit tirzepatide.
因此,我們提交的長尾是等待獲得足夠的事件以消除任何心血管安全風險,以便我們可以提交 tirzepatide。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dan.
謝謝,丹。
Josh?
喬什?
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Umer, thanks for the question.
烏默爾,謝謝你的提問。
And I think you're building on one of the comments I made, which was I don't think you can just look at sort of a move from commercial to Medicaid.
而且我認為你正在建立在我發表的評論之一的基礎上,我認為你不能只看從商業到醫療補助的轉變。
It's very much driven by plan dynamics and otherwise.
它在很大程度上受計劃動態和其他方面的驅動。
And I think without getting into too much detail, yes, it is fair to say that patients in high-deductible plans, when they're in that deductible phase, you know that we and other pharmaceutical companies have co-pay cards and other things to try to alleviate sort of the cash burden at the retail pharmacy.
而且我認為無需過多詳細說明,是的,可以公平地說,高免賠額計劃中的患者,當他們處於免賠額階段時,你知道我們和其他製藥公司有共同支付卡和其他東西試圖減輕零售藥房的現金負擔。
So we do -- the net price for those specific prescriptions to us is very low, and probably in many cases, could be lower than a Medicaid prescription.
所以我們這樣做了——這些特定處方的淨價格對我們來說非常低,而且在很多情況下,可能低於醫療補助處方。
But again, I think that gets back to what I was saying earlier, it's -- I think it's way too premature to make assumptions around what a move from commercial to Medicaid may look like.
但同樣,我認為這又回到了我之前所說的,這是 - 我認為現在就從商業到醫療補助的轉變可能會是什麼樣子做出假設還為時過早。
There are lots of complexities here and I think lots of things still to be learned about the economy and what 2021 will look like.
這裡有很多複雜性,我認為關於經濟以及 2021 年的情況還有很多事情需要了解。
But it's not -- we're not as -- I think on a math basis, as concerned as probably -- it looks like when you just look at just general commercial to Medicaid, of course, for one of the reasons that you are sort of implying in your question.
但它不是——我們不是——我認為在數學基礎上,可能很擔心——當你只看醫療補助的一般商業廣告時,當然,原因之一是你是有點暗示你的問題。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Umar, thanks for your questions.
奧馬爾,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
We will return to the line of Geoff Meacham with Bank of America.
我們將與美國銀行一起回到 Geoff Meacham 的行列。
Geoffrey Christopher Meacham - Research Analyst
Geoffrey Christopher Meacham - Research Analyst
Josh, a number of P&L questions for you.
喬希,給你一些損益問題。
You quantified the pull-forward COVID impact for a few products.
您量化了一些產品的前拉 COVID 影響。
Just wanted to ask you, are those same trends happening today in the U.S.?
只是想問你,同樣的趨勢今天在美國發生嗎?
And do you expect the OUS dynamic to eventually mirror the U.S.?
您是否期望 OUS 的動態最終反映美國的情況?
And then on your guidance, would you expect normalization of the market to be more of a 3Q or a 4Q type of event?
然後根據您的指導,您是否預計市場正常化更像是 3Q 或 4Q 類型的事件?
And then real quick, Dave, you highlighted it at the end, but how would you characterize your discussion with policymakers today versus the beginning of the year just with respect to headwinds on drug pricing and clearly, industry response to COVID having somewhat of a halo effect.
然後真的很快,戴夫,你在最後強調了它,但是你如何描述你今天與政策制定者的討論與今年年初只是關於藥品定價的逆風,顯然,行業對 COVID 的反應有點光環影響。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Geoff.
謝謝,傑夫。
Okay, Josh and then Dave.
好的,喬希,然後是戴夫。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Thanks, Geoff.
謝謝,傑夫。
So just on the $250 million we estimated in Q1, as we mentioned, about $200 million of that is in the U.S. And we talked about the 3 big product categories.
因此,正如我們所提到的,就我們在第一季度估計的 2.5 億美元而言,其中大約 2 億美元在美國。我們談到了 3 大產品類別。
I think the rest -- the product I didn't mention is sort of spread nominally among those others.
我認為其餘的-我沒有提到的產品名義上是在其他產品中傳播的。
As we look at that $200 million in the U.S., only -- less than 1/3 of that is at the wholesaler level.
當我們看到美國的 2 億美元時,只有不到 1/3 是在批發商層面。
So we saw some modest build at the wholesaler.
所以我們在批發商看到了一些適度的構建。
Most of that estimate we're making is that is either in the retail channel or all the way down to patient -- in patients' homes.
我們所做的大部分估計要么是在零售渠道中,要么是一直到患者——在患者家中。
So I think it's going to be pretty difficult.
所以我認為這將非常困難。
I mean we're assuming that, that will turn around.
我的意思是,我們假設,那將會好轉。
But I think being able to sort of make a prediction at this point is tough.
但我認為在這一點上做出預測是很困難的。
I would assume the wholesaler piece will start to normalize more quickly, and I think we're seeing that.
我認為批發商將開始更快地正常化,我認為我們正在看到這一點。
The retail and patient piece, I think, will be -- some of it will be a function of what happens in social distancing otherwise and some of it, who knows, it may be a little bit more -- we have a long tail associated with that.
我認為,零售和病人的部分將是——其中一些將是社會疏遠中發生的事情的函數,而其中一些,誰知道呢,可能會更多——我們有一條長尾巴接著就,隨即。
What we saw in Europe, it was about $50 million.
我們在歐洲看到的,大約是 5000 萬美元。
And I think most of the estimate is around our diabetes portfolio.
而且我認為大部分估計都是圍繞我們的糖尿病產品組合進行的。
And I think that one, we probably assume is a little more likely to normalize in the second half of this year.
而且我認為,我們可能假設在今年下半年恢復正常的可能性更大。
So I think, Geoff, we'll try to be transparent about this as we move through the quarters, but I think there is going to be some variability in that U.S. piece that's in the retail channel or all the way to patient homes.
所以我認為,傑夫,我們會在每個季度都保持透明,但我認為零售渠道或一直到患者家中的美國產品會有一些變化。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Dave?
戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes.
是的。
So on the policy side, I mean, I think you have it right there.
所以在政策方面,我的意思是,我認為你就在那裡。
Maybe just a little subtext.
也許只是一點潛台詞。
There's sort of 2 pressures that, prior to COVID, I think we were feeling.
在 COVID 之前,我認為我們感受到了兩種壓力。
One was a broad acceptance across both sides of the aisle that there were certain behaviors and actions, which are undesirable by the industry and should be curbed.
一個是過道兩邊的廣泛接受,即存在某些行為和行為,這些行為和行為是行業所不希望的,應該加以遏制。
Many of these actually Lilly agrees with.
其中許多實際上 Lilly 同意。
So this is about patent evergreening and strategies that involve using systems designed to create incentives in a way that perhaps is best case, in poor taste, and maybe worst-case, abusive.
因此,這是關於專利常青化和涉及使用旨在創造激勵的系統的策略,這種激勵可能是最好的情況,可能是低品味,可能是最壞的情況,濫用。
There's a bunch of Senate-related actions to curb these, and I think we're generally for them because we don't do those things.
有一堆與參議院相關的行動來遏制這些,我認為我們通常支持他們,因為我們不做這些事情。
And I think they do create a suppression of the respect for and trust in the industry.
而且我認為他們確實對行業的尊重和信任造成了壓制。
I actually think those items will continue amidst the COVID crisis, maybe even be amplified.
我實際上認為這些項目將在 COVID 危機中繼續存在,甚至可能會被放大。
Because as solutions come from the industry, which they will, it's clear that the producers of those solutions will be under a lot of scrutiny to make sure there's broad access and affordability and that we're acting reasonably.
因為隨著解決方案來自行業,他們將,很明顯,這些解決方案的生產者將受到大量審查,以確保有廣泛的可及性和可負擔性,並且我們採取合理的行動。
But I have to say, I'm speaking to my peers across the industry on many collaborative projects.
但我不得不說,我正在與整個行業的同行就許多合作項目進行交流。
And within our own company, nobody is really focused on the pure commercial side of this.
在我們自己的公司內部,沒有人真正專注於純粹的商業方面。
It's really about solving the problem.
這真的是為了解決問題。
And the spirit of collaboration and response has been tremendous.
協作和響應的精神是巨大的。
But I think that pressure will be there.
但我認為壓力會存在。
And some, there could be actions coming quickly that could strike in those areas.
有些人可能會很快採取行動,這些行動可能會在這些地區發生。
Again, from a Lilly perspective, we're less constructive on those.
同樣,從禮來的角度來看,我們在這些方面的建設性較低。
In fact, we've been for many of those proposals.
事實上,我們一直支持其中的許多提案。
On the other hand, there's -- I think from the -- more the far left in the U.S. and in certain OUS circles, this idea that perhaps the industry itself is flawed and profit motive in pharmaceuticals is a bad thing.
另一方面,我認為,在美國和某些 OUS 圈子中,更左翼的人認為,這個行業本身可能存在缺陷,而製藥業的利潤動機是一件壞事。
Of course, we vehemently disagree with that point of view.
當然,我們強烈反對這種觀點。
And I do think those voices are significantly quieted today as everyone realizes that the built-up capacities of this industry are the very thing that will allow the world to escape COVID-19.
而且我確實認為,今天這些聲音已大大減弱,因為每個人都意識到,這個行業的強大能力正是讓世界擺脫 COVID-19 的原因。
And while in the absence of a pandemic, those may seem like a premium, in the presence of a pandemic, those seem really scarce and important.
雖然在沒有大流行的情況下,這些似乎是一種溢價,但在大流行的情況下,這些似乎非常稀缺和重要。
And so I'm more bullish on that, more extreme view being significantly dissipated for some time to come.
所以我更看好這一點,更極端的觀點將在未來一段時間內顯著消散。
We need to behave ourselves appropriately and with good taste, if I can use that word, and with kind of balance to our actions as we solve the problem.
如果我能用這個詞的話,我們需要舉止得體,有品位,在解決問題時,我們的行動要保持平衡。
But I'm encouraged by that so far.
但到目前為止,我對此感到鼓舞。
So I think we've got a unique, as I said in my comments, Geoff, kind of a once-in-a-generation opportunity to reset the reputation of the industry and to put in place a policy that makes sense and balance profit motive, which we think clearly has a place to create new medicines, not just for COVID but others with curbing abusive behaviors and making sure we're earning the respect from patients and policymakers alike.
所以我認為我們有一個獨特的機會,正如我在評論中所說的,傑夫,一種千載難逢的機會來重新樹立行業的聲譽,並製定一項有意義和平衡利潤的政策動機,我們認為顯然有一個地方可以創造新藥,不僅針對 COVID,還針對其他可以遏制虐待行為並確保我們贏得患者和政策制定者的尊重的藥物。
So anyway, we'll work on that certainly over the next couple of years.
所以無論如何,我們肯定會在接下來的幾年裡努力解決這個問題。
But first, we need to work on solving the pandemic problem, and that's got all my energy right now.
但首先,我們需要努力解決大流行問題,這就是我現在所有的精力。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dave.
謝謝,戴夫。
Geoff, thanks for your questions.
傑夫,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will be Louise Chen with Cantor.
那將是與 Cantor 一起的 Louise Chen。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
So my first question is, if there's any way you could give us a sense of the underlying earnings growth if you extract the impact from COVID and any nonoperational items, even if it's just qualitatively.
所以我的第一個問題是,如果你從 COVID 和任何非運營項目中提取影響,是否有任何方法可以讓我們了解潛在的收益增長,即使它只是定性的。
And then second question is, are you expecting any economic benefit for your COVID candidates in development if they do work?
然後第二個問題是,如果您的 COVID 候選人確實有效,您是否期望他們為開發中的候選人帶來任何經濟利益?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Josh?
喬什?
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Louise, thanks.
路易絲,謝謝。
I think if you just -- at a very high level, if you just take out the revenue for Q1 that we're attributing to the $250 million we're attributing to buying patterns and sort of hold everything else the same, we get down to earnings, EPS growth on a more normalized basis of about 18% or so.
我認為,如果你只是 - 在一個非常高的水平上,如果你只是將第一季度的收入計算出來,我們將其歸因於我們歸因於購買模式的 2.5 億美元,並且保持其他一切不變,我們就會失敗就盈利而言,EPS 增長在較為正常化的基礎上約為 18% 左右。
So I think that's probably a reasonable look at the business.
所以我認為這可能是對業務的合理看法。
As with every quarter, there are other things that we could normalize out of there.
與每個季度一樣,還有其他事情可以正常化。
But I think that's probably a good sort of starting point.
但我認為這可能是一個很好的起點。
And as we've mentioned, with that, we're expecting that $250 million to normalize sometime through the year, at least in our guidance for now.
正如我們已經提到的那樣,我們預計 2.5 億美元將在一年中的某個時候正常化,至少在我們目前的指導中是這樣。
But that's where we are.
但這就是我們所在的地方。
I think then on the question around economic benefits, no, there's no benefit assumed in our guidance from any of these treatments.
然後我認為關於經濟利益的問題,不,我們的指導中沒有假設任何這些治療的好處。
Much more interested in getting these treatments to patients at this point.
在這一點上,對為患者提供這些治療更感興趣。
And frankly, I'd say at this point, we're probably just assuming some costs, for sure, associated with investment in the trials that Dan mentioned in the scale-up in manufacturing and otherwise.
坦率地說,在這一點上,我們可能只是假設了一些成本,當然,這些成本與丹在擴大製造和其他方面提到的試驗投資有關。
So some of that thinking is already embedded in our line item guidance now.
因此,其中一些想法現在已經嵌入到我們的訂單項指南中。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Josh.
謝謝,喬希。
Louise, thanks for your questions.
路易絲,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will be Vamil Divan with Mizuho Securities.
那將是瑞穗證券的 Vamil Divan。
Vamil Kishore Divan - MD
Vamil Kishore Divan - MD
Maybe just kind of a couple of questions on pipeline.
也許只是關於管道的幾個問題。
So one, mirikizumab, you mentioned a positive initial top line data in psoriasis.
所以一個,mirikizumab,你提到了銀屑病的積極初始頂線數據。
I guess I've been wondering about sort of differentiation for that product relative to the other IL-23s.
我想我一直想知道該產品相對於其他 IL-23 的區別。
Maybe if there's anything more you can share now that you have some of the top line data?
既然您擁有一些頂級數據,也許您還可以分享更多信息?
And just any update on timing, especially on the GI trials or I think you've talked about that being a kind of a more unique opportunity eventually.
以及有關時間的任何更新,尤其是關於 GI 試驗的更新,或者我認為您已經談到這最終是一種更獨特的機會。
And then going back to Alzheimer's, appreciate your comments from before.
然後回到阿爾茨海默氏症,感謝您之前的評論。
Just regarding DIAN-TU and kind of what we saw from sola and also from gantenerumab, you mentioned the plaque reduction that you've seen with donanemab, does the DIAN-TU results in any way change your thoughts around sort of plaque reduction, the biomarker impact and the impact it might have on the clinical outcome at the end of the day?
就 DIAN-TU 以及我們從 sola 和 gantenerumab 看到的那種情況,你提到了你用 donanemab 看到的斑塊減少,DIAN-TU 的結果是否以任何方式改變了你對斑塊減少的想法,生物標誌物的影響以及它最終可能對臨床結果產生的影響?
Just because we do not see that correlation in that trial.
只是因為我們在那次試驗中沒有看到這種相關性。
I know it's a small trial, but any perspective would be helpful.
我知道這是一個小試驗,但任何觀點都會有所幫助。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Vamil.
謝謝,瓦米爾。
We'll go to Patrik for the mirikizumab question and then Dan for the Alzheimer's question.
我們將向 Patrik 詢問 mirikizumab 問題,然後向 Dan 詢問阿爾茨海默氏症問題。
Patrik Jonsson - Senior VP & President of Lilly Bio-Medicines
Patrik Jonsson - Senior VP & President of Lilly Bio-Medicines
Thank you very much.
非常感謝。
We announced that mirikizumab met all the co-primary and the key secondary end points in the first OASIS 1 trial, which is the placebo-controlled, 52-week trial in psoriasis.
我們宣佈在第一個 OASIS 1 試驗中,mirikizumab 滿足所有共同主要終點和關鍵次要終點,這是一項安慰劑對照、為期 52 週的銀屑病試驗。
And that is what we expected as well.
這也是我們所期望的。
We are setting the bar extremely high in psoriasis with Taltz and have been able now to demonstrate in 5 head-to-head trials superiority.
我們用 Taltz 為銀屑病設定了極高的標準,現在已經能夠在 5 次面對面試驗中證明其優越性。
And it really goes in psoriasis, both in terms of time to onset, the level of clearance and the sustainability of a clearance.
它確實適用於銀屑病,無論是在發病時間、清除水平和清除的可持續性方面。
So we are waiting now for the second Phase III trial, which is the head-to-head trial versus secukinumab, 52-week data.
所以我們現在正在等待第二個 III 期試驗,這是與 secukinumab 的頭對頭試驗,52 週數據。
And I think that will particularly inform our decision on how we progress with a psoriasis indication.
我認為這將特別有助於我們決定我們如何在牛皮癬適應症方面取得進展。
For miri, I think we have also stated very clearly, but the big excitement is around ulcerative colitis and Crohn's disease.
對於miri,我想我們也已經說得很清楚了,但最大的興奮是圍繞潰瘍性結腸炎和克羅恩病。
And we really believe that in ulcerative colitis there is a big unmet need.
我們真的相信潰瘍性結腸炎存在很大的未滿足需求。
And we have potentially first-in-class and best-in-class asset in mirikizumab.
我們在 mirikizumab 方面擁有潛在的一流和一流資產。
And we also know that the biologic penetration is relatively low.
而且我們也知道生物滲透率相對較低。
And we have previously shared that we expect the top line readout for the induction data in Q4 this year and the maintenance top line in 2021.
我們之前曾分享過,我們預計今年第四季度的感應數據的頂線讀數和 2021 年的維護頂線。
For Crohn's disease, we have announced earlier, but we will do a top line announcement in 2022.
對於克羅恩病,我們之前已經宣布過,但我們將在 2022 年發布一線公告。
At this time and with COVID-19, we are certain that there will be a delay in one or both of those programs.
目前,對於 COVID-19,我們確信其中一項或兩項計劃將會延遲。
However, we believe it's also premature to quantify the impact.
然而,我們認為量化影響還為時過早。
And as the situation evolves, we will have a better understanding of the impact as well as our ability to mitigate those.
隨著情況的發展,我們將更好地了解影響以及我們減輕這些影響的能力。
And the delay here that's important to state, it's driven by difficulties to access the study sites, but particularly infusion centers, and the ability for some of those centers to conduct and perform endoscopies.
這裡的延遲很重要,這是由於難以進入研究地點,特別是輸液中心,以及其中一些中心進行和進行內窺鏡檢查的能力。
So overall, a high level of excitement still for both ulcerative colitis and Crohn's disease and the head-to-head data versus secukinumab will guide our decision moving forward on psoriasis.
因此,總體而言,潰瘍性結腸炎和克羅恩病的高度興奮以及與蘇金單抗的頭對頭數據將指導我們在銀屑病方面的決定。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Patrik, Dan?
謝謝,帕特里克,丹?
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Daniel M. Skovronsky - Senior VP, Chief Scientific Officer & President of Lilly Research Labs
Yes.
是的。
As for Alzheimer's DIAN-TU, I mean, of course, this was a really heroic and difficult effort to study effects of drugs in the dominantly inherited Alzheimer's population.
至於阿爾茨海默氏症的 DIAN-TU,我的意思是,當然,這是一項研究藥物對顯性遺傳的阿爾茨海默氏症人群的影響的非常艱鉅而艱鉅的努力。
I think, unfortunately, there's just a small number of patients who completed the trial, especially at the higher dose for solanezumab.
我認為,不幸的是,只有少數患者完成了試驗,尤其是在 solanezumab 的較高劑量下。
So tough to make conclusions about any clinical effects of sola there.
很難就 sola 的任何臨床效果下結論。
But as you pointed out, sola is not a plaque-lowering antibody.
但正如你所指出的,sola 不是降低斑塊的抗體。
It works on soluble A beta.
它適用於可溶性 A beta。
So I can't draw conclusions about plaque lowering from solanezumab data.
所以我不能從 solanezumab 數據中得出關於降低斑塊的結論。
I think, though, the most important things to look at in DIAN are the biomarker outcomes.
不過,我認為,在 DIAN 中最重要的事情是生物標誌物的結果。
And perhaps, if you think about the biomarker outcomes, you could add a little bit of confidence around plaque lowering.
也許,如果您考慮生物標誌物的結果,您可以對降低斑塊增加一點信心。
But once again, it's a small study and hard to draw those conclusions.
但再一次,這是一項小型研究,很難得出這些結論。
I look forward to the results from our Phase II trial, which I think should be a clean trial, a clean test of the hypothesis in a relatively homogenous population.
我期待我們的 II 期試驗的結果,我認為這應該是一個乾淨的試驗,一個在相對同質的人群中對假設的干淨測試。
But the data is not very far off right now.
但目前的數據並不遙遠。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dan.
謝謝,丹。
Vamil, thanks for your questions.
瓦米爾,謝謝你的提問。
And we'll go into the next caller, please?
我們將進入下一個呼叫者,好嗎?
Operator
Operator
That will be from Tim Anderson with Wolfe Research.
這將來自沃爾夫研究公司的蒂姆安德森。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
A couple of questions, please.
有幾個問題,請。
On tirzepatide, you mentioned results in 2020, and everyone knows that, I think.
關於 tirzepatide,您提到了 2020 年的結果,我想每個人都知道這一點。
Is that just likely to be top line?
這很可能是頂線嗎?
Or are we likely to see a more complete set of results in some form or another, whether it's publication or presentation?
還是我們可能會以某種形式看到更完整的結果集,無論是出版物還是演示文稿?
And then second question is on Tyvyt, your PD-1 in China.
然後第二個問題是關於 Tyvyt,您在中國的 PD-1。
I feel like over time, I've gotten mixed messages from the company on the importance of this product.
我覺得隨著時間的推移,我從公司那裡得到了關於這個產品重要性的混合信息。
Maybe a year ago, I was talking to one of the members of senior management, and it was kind of described as a China-only product of smaller importance.
也許一年前,我和一位高級管理人員交談,它被描述為僅在中國市場推出的不太重要的產品。
But I don't know if that's still the current point of view.
但我不知道這是否仍然是當前的觀點。
I asked about it last quarter.
我上個季度問過這個問題。
I didn't get much of an answer.
我沒有得到太多答案。
So the question is really two-fold on Tyvyt.
所以關於 Tyvyt 的問題實際上是雙重的。
The development program from here in China in terms of next tumor types.
就下一個腫瘤類型而言,中國的開發計劃。
And perhaps more importantly, your plans to take this outside of China into developed markets, U.S., Europe or anywhere else that's traditionally considered developed.
也許更重要的是,您計劃將其帶到中國以外的發達市場、美國、歐洲或傳統上被認為是發達的任何其他地方。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Tim.
謝謝,蒂姆。
We'll go to Mike for the tirzepatide question and then Dave will take the question on Tyvyt.
我們將向 Mike 提問 tirzepatide 問題,然後 Dave 將回答有關 Tyvyt 的問題。
Michael B. Mason - Senior VP & President of Lilly Diabetes
Michael B. Mason - Senior VP & President of Lilly Diabetes
Yes.
是的。
Thanks for the question.
謝謝你的問題。
Just directly, we do believe we'll have our first top line readouts of the SURPASS program for the first trial in Q4 of 2020 and then additional readouts, top line as well as at medical meetings going into '21.
直接地說,我們相信我們將在 2020 年第四季度的第一次試驗中獲得 SURPASS 計劃的第一個頂級讀數,然後在進入 21 年的醫療會議上進行額外的讀數、頂線以及醫學會議。
Thanks for the question.
謝謝你的問題。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes.
是的。
Tim, as it relates to Tyvyt, I don't think -- your read of the prior commentary is wrong.
蒂姆,因為它與 Tyvyt 相關,我不認為 - 您對先前評論的閱讀是錯誤的。
I think we originally collaborated with Innovent as a China-only play for biologics and cancer and a few other biosimilar opportunities.
我認為我們最初與 Innovent 合作是為了在中國開展生物製劑和癌症以及其他一些生物仿製藥的機會。
But there are -- 2 things have changed, which I think -- and today, we're breaking out China for the first time.
但是有兩件事發生了變化,我認為這是今天,我們第一次在中國爆發。
So maybe that's the third thing that's changed.
所以也許這是改變的第三件事。
But one is that Tyvyt was the only PD-1 put on the [NRDL] (corrected by company after the call) nationally in China.
但其中之一是 Tyvyt 是中國全國唯一被列入 [NRDL](由公司在電話會議後更正)的 PD-1。
So that does change the economic profile of it for us and certainly for the Chinese business.
因此,這確實改變了我們的經濟狀況,當然也改變了中國企業的經濟狀況。
And the second is the positive data that was released in the combination with pemetrexed in first-line non-small cell lung cancer, which is very encouraging, and I think does change the trajectory of that certainly in China.
第二個是與培美曲塞聯合治療一線非小細胞肺癌的陽性數據,非常令人鼓舞,我認為確實改變了中國的發展軌跡。
Of course, right now, we're very focused on the Chinese opportunity, and that remains our focus in the short term.
當然,目前我們非常關注中國的機會,這仍然是我們短期內的重點。
And as Josh mentioned, I think, in his remarks, there was great volume growth in China for our oncology portfolio, and Tyvyt is a key part of that.
正如 Josh 所說,我認為,在他的講話中,我們的腫瘤產品組合在中國的銷量增長很大,而 Tyvyt 是其中的關鍵部分。
So anyway, great partnership with Innovent.
因此,無論如何,與 Innovent 建立了良好的合作關係。
They do a great job, and it's been a successful way to think about building our business, which was a little bit underrepresented in China a decade ago through local partnerships with local innovators, and we're really pleased with how that's progressed.
他們做得很好,這是考慮建立我們業務的成功方式,十年前通過與當地創新者建立本地合作夥伴關係,這在中國的代表性有點不足,我們對取得的進展感到非常滿意。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dave.
謝謝,戴夫。
Tim, thanks for your questions.
蒂姆,謝謝你的提問。
Next caller, please?
下一個來電者,好嗎?
Operator
Operator
That will be Carter Gould with Barclays.
那將是 Barclays 的 Carter Gould。
Carter Lewis Gould - Senior Analyst
Carter Lewis Gould - Senior Analyst
I just wanted to, I guess, dig into the comment over the inevitable fiscal pressure on government-funded healthcare, specifically thinking about Europe and the pressure on budgets there.
我想,我只是想深入探討一下有關政府資助的醫療保健不可避免的財政壓力的評論,特別是考慮歐洲和那裡的預算壓力。
I guess are you guys viewing it as a possibility, probability or likelihood this incremental pricing pressure in Europe, I guess, looking out later this year or into next?
我猜你們是否將其視為一種可能性、概率或可能性,我猜,在今年晚些時候或明年展望歐洲的這種增加的定價壓力?
I appreciate any thoughts there.
我很感激那裡的任何想法。
And then following up on the Tyvyt data -- Tyvyt discussion, when could we expect the ORIENT-11 data to be presented?
然後跟進 Tyvyt 數據—— Tyvyt 討論,我們什麼時候可以期待 ORIENT-11 數據?
Is that something that could still come in, in the first half of this year?
今年上半年還有可能出現這種情況嗎?
Or will we have to wait until the back half of the year?
還是要等到下半年?
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Carter.
謝謝,卡特。
We'll go to Dave for the question for Europe and then Anne for the question about the Tyvyt ORIENT-11 data.
我們將向 Dave 詢問有關歐洲的問題,然後向 Anne 詢問有關 Tyvyt ORIENT-11 數據的問題。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes.
是的。
As it relates to Europe, and I would say this extrapolates to other government-run health systems like Australia, Canada, Japan as well.
因為它與歐洲有關,我會說這也適用於其他政府運營的衛生系統,如澳大利亞、加拿大、日本。
We saw a policy response in nearly every jurisdiction following the '08, '09 fiscal crisis.
在 08 和 09 年的財政危機之後,我們幾乎在每個司法管轄區都看到了政策反應。
Well, this isn't a fiscal crisis.
嗯,這不是財政危機。
It's -- there will be a fiscal crisis brought on by the pandemic in many of these economies.
這是 - 在許多這些經濟體中,流行病將引發財政危機。
It will lower tax receipts.
它將降低稅收收入。
And then the governments will need to look for methods to reduce their spending.
然後,政府將需要尋找減少支出的方法。
I think we can predict that with almost absolute certainty.
我認為我們幾乎可以絕對肯定地預測到這一點。
One of the items on their list is often drugs because it's an input that can be negotiated or, in many cases, they don't need to negotiate.
他們清單上的項目之一通常是毒品,因為這是可以協商的輸入,或者在許多情況下,他們不需要協商。
They just change their rules.
他們只是改變他們的規則。
And we saw that certainly happen and create a 3- or 4-year series of policy moves, depending on the relative strength of the economy that suppressed drug pricing in places like Europe and Australia, Canada.
我們看到這種情況肯定會發生,並製定了一系列為期 3 年或 4 年的政策舉措,具體取決於抑制歐洲和澳大利亞、加拿大等地藥品定價的經濟相對實力。
So we're projecting that in the future.
因此,我們計劃在未來實現這一點。
As Josh mentioned, we don't see a lot of that happening in '20.
正如 Josh 所提到的,我們在 20 年看不到很多這樣的事情發生。
Probably tax receipts falling in '21 lead to legislative actions in '21 and '22, which leads to suppressed pricing beyond that.
21 年的稅收收入下降可能會導致 21 年和 22 年的立法行動,從而導致定價受到抑制。
That's, to me, a certainty across the industry.
對我來說,這是整個行業的確定性。
And then the real question is how relatively innovative is your portfolio because a lot of these policies tend to be using -- leverage governments can have when there's relative substitutability.
然後真正的問題是您的投資組合相對創新程度如何,因為許多這些政策往往會使用——當存在相對可替代性時,政府可以擁有槓桿作用。
So the more innovative the portfolio, the more immune you become to these things.
因此,投資組合越創新,您對這些東西就越免疫。
Obviously, we're working hard on that side of the equation.
顯然,我們正在努力解決這個問題。
And hopefully, we'll be on the positive end of the industry.
希望我們將處於行業的積極端。
But I suspect that as an industry as a whole will be -- these international pressures will present themselves across everyone's portfolios to some degree or another.
但我懷疑,作為一個整體,這些國際壓力將在某種程度上體現在每個人的投資組合中。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Thanks, Dave.
謝謝,戴夫。
Anne?
安妮?
Anne E. White - Senior VP & President of Lilly Oncology
Anne E. White - Senior VP & President of Lilly Oncology
Yes.
是的。
Thanks for the question on Tyvyt.
感謝關於 Tyvyt 的問題。
So with the Phase III ORIENT study, as you know, it's an interim analysis that was positive, and we're very excited about initiating that submission with Innovent to the regulatory authorities in China.
因此,如您所知,第三階段 ORIENT 研究是一項積極的中期分析,我們很高興與信達一起向中國監管機構提交該研究報告。
And we will be submitting that data for a medical meeting in the second half of this year.
我們將在今年下半年的醫療會議上提交這些數據。
So you'll see it in the second half of 2020.
所以你會在 2020 年下半年看到它。
Kevin Hern - VP of IR
Kevin Hern - VP of IR
Great.
偉大的。
Thanks, Anne.
謝謝,安妮。
Carter, thanks for your questions.
卡特,謝謝你的提問。
That's -- we've exhausted the queue.
那是 - 我們已經排滿了隊列。
So we'll go to Dave for the close.
所以我們會去戴夫為結束。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
All right.
好的。
Thank you all.
謝謝你們。
We appreciate your participation in the call and your interest in the company.
感謝您參加電話會議以及您對公司的興趣。
Obviously, different times today.
顯然,今天不同的時代。
And just on a personal note, I know many of the sell-side community are based on the East Coast, and we hope you're all well and your families are functioning and certainly healthy through this crisis.
就個人而言,我知道許多賣方社區都位於東海岸,我們希望你們一切都好,你們的家人在這場危機中正常運轉,當然也很健康。
As usual, any follow-up calls or questions can be directed to our really incredible Investor Relations team.
像往常一樣,任何後續電話或問題都可以直接聯繫我們非常出色的投資者關係團隊。
And again, hope you all stay well, and we'll be in touch soon.
再次,希望你們一切都好,我們會盡快與您聯繫。
Take care.
小心。
Operator
Operator
Ladies and gentlemen, that will conclude your conference call for today.
女士們,先生們,今天的電話會議到此結束。
Thank you for your participation and for using AT&T Executive TeleConference service.
感謝您的參與和使用 AT&T 行政電話會議服務。
You may now disconnect.
您現在可以斷開連接。