禮來公司 (LLY) 2020 Q2 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q2 2020 Earnings Call.

    女士們,先生們,感謝您的支持,歡迎參加禮來公司 2020 年第二季度財報電話會議。

  • (Operator Instructions) As a reminder, today's call is being recorded.

    (操作員說明)作為提醒,今天的通話正在錄音中。

  • I will now turn the call over to your host, VP, Investor Relations, Kevin Hern.

    我現在將把電話轉給您的主持人,投資者關係副總裁 Kevin Hern。

  • Please go ahead, sir.

    請繼續,先生。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thank you.

    謝謝你。

  • Good morning, and thank you for joining us for Eli Lilly and Company's Q2 2020 Earnings Call.

    早上好,感謝您參加禮來公司 2020 年第二季度財報電話會議。

  • 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有:禮來公司董事長兼首席執行官戴夫·里克斯;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 Sarah Smith and Mike Czapar of the Investor Relations team.

    投資者關係團隊的 Sarah Smith 和 Mike Czapar 也加入了我們的行列。

  • 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,我們的實際結果可能存在重大差異,包括 COVID-19 大流行的影響程度和持續時間,以及幻燈片 3 中列出的其他因素以及我們最新表格 10-K、10-Q 中列出的因素以及向證券交易委員會提交的任何 8-K。

  • 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。

  • A lot has changed in the world since our last earnings call.

    自我們上次召開財報電話會議以來,世界發生了很多變化。

  • Science has continued to advance our understanding of COVID-19, and efforts across the industry to develop treatments and vaccines are progressing rapidly.

    科學繼續推進我們對 COVID-19 的理解,整個行業開發治療方法和疫苗的努力進展迅速。

  • While some regions and countries have begun to reopen, COVID-19 cases and deaths are climbing in other places.

    雖然一些地區和國家已經開始重新開放,但其他地方的 COVID-19 病例和死亡人數正在攀升。

  • Despite these challenges, Lilly continues to demonstrate resilience and resourcefulness to progress our mission of making medicines for the millions of patients we serve.

    儘管存在這些挑戰,禮來公司仍繼續展示出韌性和足智多謀,以推進我們為我們服務的數百萬患者製造藥物的使命。

  • I've never been more proud of the company and my 35,000 teammates.

    我為公司和我的 35,000 名隊友感到無比自豪。

  • This past quarter was unlike any other during my tenure as CEO, concurrently combating social, economic and public health crises.

    上個季度與我擔任首席執行官期間的任何其他季度都不同,同時應對社會、經濟和公共衛生危機。

  • Economic uncertainty remains as high unemployment persists in many countries.

    由於許多國家的高失業率持續存在,經濟不確定性依然存在。

  • As expected, our business experienced headwinds this quarter with patients unable to see doctors or access health care during periods when the economies were shut down to prevent the spread of COVID-19 and by the dwindling -- or the -- and by the unwinding of forward buying into Q1 that occurred.

    正如預期的那樣,我們的業務在本季度遇到了逆風,在經濟關閉以防止 COVID-19 傳播以及由於減少或關閉經濟期間,患者無法看醫生或獲得醫療保健。發生的第一季度遠期購買。

  • Overall, our year-to-date results are strong and indicate -- indicative of the underlying trends.

    總體而言,我們年初至今的業績強勁,表明了潛在的趨勢。

  • I'm proud of Lilly's efforts to ensure patients have access to their medicines, to find creative ways to ensure we advance critical research and to advance our ongoing efforts to develop treatments for COVID-19.

    我為禮來(Lilly)努力確保患者能夠獲得他們的藥物、尋找創造性的方法來確保我們推進關鍵研究以及推進我們為開發 COVID-19 治療方法所做的努力感到自豪。

  • We continue to staff our manufacturing facilities around the globe with essential personnel to ensure there are no disruptions in the supply of medicine.

    我們將繼續為我們在全球的製造工廠配備必要的人員,以確保藥品供應不會中斷。

  • And in recent weeks, we resumed activity in the majority of our clinical trials, where enrollment had been paused.

    最近幾週,我們恢復了大部分臨床試驗的活動,這些試驗的註冊已經暫停。

  • We're resuming in-person promotional activities when it's safe on a country-by-country and on a state-by-state basis in the U.S. And we will continue to use these virtual engagement tools we've built to augment in-person promotional activities.

    我們將在美國的各個國家和州安全的情況下恢復面對面的促銷活動。我們將繼續使用我們為增強面對面而構建的這些虛擬參與工具促銷活動。

  • Throughout Q2, we saw a steady increase in customer contacts and medical education touch points as we leveraged new platforms to reach physicians.

    在整個第二季度,隨著我們利用新平台接觸醫生,我們看到客戶聯繫和醫學教育接觸點穩步增加。

  • We continue to see increase in interest and volume of virtual interactions from physicians and expect a hybrid model of in-person and remote engagement for some time in the U.S. as well as internationally.

    我們繼續看到醫生對虛擬互動的興趣和數量不斷增加,並期待在美國和國際上一段時間內出現面對面和遠程參與的混合模式。

  • We also made good progress this quarter executing our R&D strategy, launching 2 new medicines in the U.S., including Retevmo, the first therapy ever approved for patients with RET-driven lung and thyroid cancers; and Lyumjev, a fast-acting mealtime insulin for patients with type 1 and type 2 diabetes.

    本季度我們在執行研發戰略方面也取得了良好進展,在美國推出了 2 種新藥,包括 Retevmo,這是有史以來第一個獲批用於 RET 驅動的肺癌和甲狀腺癌患者的療法;和 Lyumjev,一種用於 1 型和 2 型糖尿病患者的速效餐時胰島素。

  • Taltz in nonradiographic axSpA; Cyramza in combination with erlotinib for EGFR-mutated non-small cell lung cancer; and Tauvid, our new diagnostic for patients with Alzheimer's disease, were also approved in the U.S.

    非放射學 axSpA 中的 Taltz; Cyramza 聯合厄洛替尼治療 EGFR 突變的非小細胞肺癌;我們用於阿爾茨海默病患者的新診斷方法 Tauvid 也在美國獲得批准。

  • Several positive Phase III readouts this quarter include Verzenio in adjuvant breast cancer, now the first and the only CDK4/6 inhibitor to succeed in this population; mirikizumab in psoriasis compared to both placebo and head-to-head versus Cosentyx; and just today, in collaboration with Boehringer Ingelheim, Jardiance in heart failure patients with reduced injection fraction both with and without diabetes.

    本季度的幾個積極的 III 期讀數包括 Verzenio 在輔助乳腺癌中,現在是第一個也是唯一一個在該人群中成功的 CDK4/6 抑製劑;銀屑病中的mirikizumab與安慰劑和頭對頭與Cosentyx的比較;就在今天,Jardiance 與 Boehringer Ingelheim 合作,治療患有糖尿病和不患有糖尿病的心力衰竭患者的注射分數降低。

  • We also continue to make progress on our potential COVID-19 therapies, notably the initiation of multiple clinical trials developing neutralizing antibodies both as monotherapy and in combination.

    我們還繼續在潛在的 COVID-19 療法方面取得進展,特別是啟動了多項臨床試驗,開發中和抗體作為單一療法和聯合療法。

  • Dan will provide you with more detail during the R&D update.

    Dan 將在研發更新期間為您提供更多詳細信息。

  • The unprecedented pace at which we're executing this project across our development and manufacturing organizations is evidence of what we are capable as an innovative company.

    我們以前所未有的速度在我們的開發和製造組織中執行這個項目,這證明了我們作為一家創新公司的能力。

  • As I mentioned earlier, our Q2 business results were negatively impacted by COVID-19.

    正如我之前提到的,我們的第二季度業務業績受到 COVID-19 的負面影響。

  • However, we remain confident in the underlying fundamentals of our business.

    然而,我們仍然對我們業務的基本面充滿信心。

  • COVID-19 had a meaningful impact on economic activity.

    COVID-19 對經濟活動產生了有意義的影響。

  • And we observed the following trends in the U.S.: a sharp decline in the number of patient visits to physicians dropping to roughly 50% of pre-COVID-19 levels; reduced visits translated into fewer new prescriptions with the peak impact in late April and early May in most therapeutic classes; a slow return to health care activity through a combination of telehealth and in-person visits as IQVIA data showed patient visits were back to 85% of pre-COVID-19 levels in June; and new prescriptions slowly beginning to recover, although some variation across therapeutic areas.

    我們在美國觀察到以下趨勢:就診的患者數量急劇下降,降至 COVID-19 之前水平的約 50%;在大多數治療課程中,4 月底和 5 月初的影響最大的是訪問次數減少導致新處方減少;由於 IQVIA 數據顯示,6 月份患者就診率恢復到 COVID-19 之前水平的 85%,因此通過遠程醫療和親自就診相結合的方式緩慢恢復醫療保健活動;和新的處方慢慢開始恢復,儘管治療領域的一些變化。

  • While the outlook for economic activity is uncertain, we remain optimistic that patients, physicians and hospital systems will continue to find ways to ensure patients can access the medicines they need.

    儘管經濟活動前景不明朗,但我們仍然樂觀地認為,患者、醫生和醫院系統將繼續尋找確保患者能夠獲得所需藥物的方法。

  • Turning to our Q2 results.

    轉向我們的第二季度業績。

  • As expected, reduced patient visits and inventory dynamics were both a drag on otherwise solid total prescription trends.

    正如預期的那樣,減少的患者就診和庫存動態都拖累了原本穩固的總處方趨勢。

  • Revenue declined 2% compared to Q2 2019.

    與 2019 年第二季度相比,收入下降了 2%。

  • And we estimated revenue was negatively impacted by the reversal of largely all of the $250 million of stocking related to COVID-19 that we experienced in Q1.

    我們估計收入受到第一季度與 COVID-19 相關的 2.5 億美元庫存的大部分逆轉的負面影響。

  • While most existing prescriptions were maintained, new patient prescriptions declined in Q2 relative to pre-COVID-19 baselines.

    儘管大多數現有處方得以維持,但與 COVID-19 之前的基線相比,第二季度的新患者處方有所下降。

  • We estimate this impact to have been about $250 million across the portfolio.

    我們估計這種影響在整個投資組合中約為 2.5 億美元。

  • Taking into account current trends, we are on track to deliver the financial goals we established for 2020.

    考慮到當前趨勢,我們有望實現我們為 2020 年制定的財務目標。

  • The strength of our new products, our ability to scale them worldwide and our productivity agenda position us well to continue to deliver robust business performance and to create shareholder value.

    我們新產品的實力、我們在全球範圍內擴展它們的能力以及我們的生產力議程使我們能夠繼續提供強勁的業務績效並為股東創造價值。

  • Moving to Slide 5. You'll see the full list of key events since our last earnings call.

    轉到幻燈片 5。您將看到自上次財報電話會議以來關鍵事件的完整列表。

  • Before Josh discusses our financial results, just a few comments about the executive orders that were announced last Friday.

    在 Josh 討論我們的財務業績之前,請對上週五宣布的行政命令發表一些評論。

  • We all share the goal of making medicines more affordable and accessible to patients and believe concepts, such as rebate reform and the sharing of savings within the eligible 340B patient population, offer real opportunities to lower the out-of-pocket cost for patients quickly.

    我們都有共同的目標,即讓患者更負擔得起和更容易獲得藥物,並相信諸如退稅改革和在符合條件的 340B 患者群體中分享儲蓄等概念,為快速降低患者的自付費用提供了真正的機會。

  • However, as I've noted before, the concept of international price indexing is a bad policy.

    然而,正如我之前所指出的,國際價格指數的概念是一項糟糕的政策。

  • This policy will have almost no benefit to patient out-of-pocket costs, but together with reimportation will most assuredly have serious negative consequences for patients, for the safety of our supply chain and for the future of innovation.

    這項政策對患者的自付費用幾乎沒有任何好處,但再加上重新進口,肯定會對患者、我們供應鏈的安全和創新的未來產生嚴重的負面影響。

  • So now is the wrong time to introduce sweeping government actions that will at best distract and at worst cripple the same industry that's racing to discover vaccines and treatments to defeat COVID-19.

    因此,現在是引入全面政府行動的錯誤時機,這充其量只會分散注意力,最壞的情況是削弱正在競相發現疫苗和治療方法以擊敗 COVID-19 的同一個行業。

  • Now I'll turn the call over to Josh to review our Q2 results in more detail and provide an update on our financial guidance for 2020.

    現在,我將把電話轉給喬什,以更詳細地審查我們的第二季度業績,並提供我們 2020 年財務指導的最新信息。

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Thanks, Dave, and good morning, everyone.

    謝謝,戴夫,大家早上好。

  • Moving to Slide 6 and 7. Our non-GAAP financial performance in Q2 and during the first half of 2020 was impacted by COVID-19 across many lines of the income statement.

    轉到幻燈片 6 和 7。我們在第二季度和 2020 年上半年的非公認會計原則財務業績在損益表的許多方面受到 COVID-19 的影響。

  • As Dave mentioned, revenue declined 2% this quarter compared to Q2 2019 and was negatively impacted by COVID-19 in 2 ways.

    正如 Dave 提到的,與 2019 年第二季度相比,本季度的收入下降了 2%,並且受到 COVID-19 在兩個方面的負面影響。

  • First, largely all of the $250 million of COVID-related stocking in Q1 reversed as excess supply in the channel and in medicine cabinets was consumed and Q2 closing inventory returned to historically normal levels.

    首先,第一季度與 COVID 相關的 2.5 億美元庫存基本全部逆轉,因為渠道和藥櫃中的供應過剩被消耗,第二季度期末庫存恢復到歷史正常水平。

  • Second, reduced patient visits due to COVID-19 resulted in lower new prescriptions across many of our brands, which we estimate had a negative impact on Q2 revenue of approximately $250 million as well.

    其次,由於 COVID-19 導致患者就診次數減少,導致我們許多品牌的新處方減少,我們估計這也對第二季度約 2.5 億美元的收入產生了負面影響。

  • We estimate this impact to be a temporary step-down in market size, which we expect will return to pre-COVID levels over the balance of the year with the pace of recovery varying by therapeutic area.

    我們估計這種影響是市場規模的暫時下降,我們預計市場規模將在今年餘下時間恢復到 COVID 之前的水平,恢復速度因治療領域而異。

  • Given the stocking and destocking seen between quarters, our first half performance of 7% sales growth in constant currency is a more accurate reflection of underlying performance.

    考慮到季度之間的庫存和去庫存情況,我們上半年銷售額增長 7%(按固定匯率計算)的業績更準確地反映了基本業績。

  • Gross margin as a percent of revenue in Q2 was 79.6%, a decline of 140 basis points versus Q2 2019, driven primarily by the negative impact of price, which I'll describe in more detail in a moment.

    第二季度毛利率佔收入的百分比為 79.6%,與 2019 年第二季度相比下降了 140 個基點,主要受價格負面影響的推動,我稍後將對此進行更詳細的描述。

  • Moving down the P&L.

    向下移動損益表。

  • Selling, general and administrative expenses declined 9% this quarter compared to Q2 2019 as reduced marketing and travel and meeting expenses were only partially offset by investments in virtual tactics.

    與 2019 年第二季度相比,本季度的銷售、一般和管理費用下降了 9%,因為減少的營銷、差旅和會議費用僅被虛擬策略投資部分抵消。

  • Research and development expenses declined 1% as the pause in clinical trials have shifted activity and expenses to the second half of 2020.

    由於臨床試驗的暫停將活動和費用轉移到 2020 年下半年,研發費用下降了 1%。

  • In total, operating income decreased 2% compared to Q2 2019.

    總體而言,營業收入與 2019 年第二季度相比下降了 2%。

  • During the first half -- sorry, I'm just having a technical issue here.

    上半場——抱歉,我只是遇到了技術問題。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Just take this one.

    就拿這個吧。

  • We just had a system problem.

    我們只是遇到了系統問題。

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • So in total, operating income decreased 2% compared to Q2 2019.

    因此,總體而言,營業收入與 2019 年第二季度相比下降了 2%。

  • During the first half of 2020, operating income increased by 14% as revenue growth outpaced operating expense growth by 500 basis points.

    2020 年上半年,營業收入增長 14%,收入增長超過營業費用增長 500 個基點。

  • Operating income as a percent of revenue was 28% during the second quarter and 29.1% for the first half of 2020.

    第二季度營業收入佔收入的百分比為 28%,2020 年上半年為 29.1%。

  • We continue to adapt the way we allocate resources to efficiently operate in an environment where the threat of COVID-19 is likely to be disruptive for a sustained period of time.

    我們將繼續調整我們分配資源的方式,以便在 COVID-19 的威脅可能在持續一段時間內造成破壞的環境中有效運營。

  • We're expanding our virtual capabilities to support executing our strategy and are committed to our 2020 full year operating margin target of 31%.

    我們正在擴展我們的虛擬能力以支持執行我們的戰略,並致力於實現我們 2020 年全年 31% 的營業利潤率目標。

  • Other income and expense was income of $447 million this quarter compared to an expense of $32 million in Q2 2019.

    其他收入和支出為本季度的收入為 4.47 億美元,而 2019 年第二季度的支出為 3200 萬美元。

  • This quarter's other income was primarily driven by the increase in value of investments in Asian biopharma companies as well as previously private companies that went public here in the U.S. We have investments across a range of private and public biopharma companies as a part of our external innovation strategy.

    本季度的其他收入主要是由於對亞洲生物製藥公司以及在美國上市的以前私營公司的投資價值增加。作為我們外部創新的一部分,我們對一系列私營和公共生物製藥公司進行了投資戰略。

  • And these investments allow us to nurture emerging science and access potential new medicines and novel modalities.

    這些投資使我們能夠培育新興科學並獲得潛在的新藥和新模式。

  • 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 13.4%, an increase of 340 basis points compared with the same quarter last year, driven by the mix of earnings in higher tax jurisdictions and a lower net discrete tax benefit than last year.

    我們的稅率為 13.4%,與去年同期相比增加了 340 個基點,這是由於稅收較高的司法管轄區的收入組合和淨離散稅收優惠低於去年。

  • At the bottom line, earnings per share increased 26% in Q2 as the sizable gain on public equities more than offset the decline in operating income.

    歸根結底,第二季度每股收益增長了 26%,因為公開股票的可觀收益超過了營業收入的下降。

  • During the first half of 2020, earnings per share increased 29%.

    2020年上半年,每股收益增長了29%。

  • On Slide 8, we quantify the effect of price, rate and volume on revenue.

    在幻燈片 8 中,我們量化了價格、費率和數量對收入的影響。

  • Worldwide revenue declined 2% during Q2 as volume growth of 6% was offset by price.

    由於 6% 的銷量增長被價格抵消,第二季度全球收入下降了 2%。

  • Foreign exchange had an additional 1% negative impact on revenue growth.

    外匯對收入增長產生了額外 1% 的負面影響。

  • During the first half of 2020, revenue grew 7% in constant currency as volume grew 13% and price declined 7% or 5% excluding the impact Alimta and Tyvyt had in China.

    2020 年上半年,不計 Alimta 和 Tyvyt 在中國的影響,收入增長 7%(按固定匯率計算),銷量增長 13%,價格下降 7% 或 5%。

  • U.S. revenue declined 3% compared to the second quarter of 2019.

    與 2019 年第二季度相比,美國收入下降了 3%。

  • Volume growth of 4% was led by Trulicity, Taltz, Emgality and Verzenio.

    Trulicity、Taltz、Emgality 和 Verzenio 引領了 4% 的銷量增長。

  • As mentioned earlier, we saw destocking at the wholesaler and patient level due to COVID-19 that contributed approximately $200 million of negative impact during the quarter.

    如前所述,由於 COVID-19 在本季度造成了約 2 億美元的負面影響,我們看到批發商和患者層面的庫存減少。

  • In addition, we estimate reduced new prescriptions due to COVID-19 negatively impacted Q2 revenue by approximately $150 million.

    此外,我們估計,由於 COVID-19 對第二季度收入的負面影響,新處方減少了約 1.5 億美元。

  • Pricing was an 8% drag on U.S. revenue growth this quarter, impacted by predominantly changes to estimates for rebates and discounts, most notably impacting Humalog, which was driven primarily by favorable Medicaid adjustments in the prior period and unfavorable commercial adjustments in the current period; then to a lesser extent, by higher growth across the portfolio in lower net price segments and increased rebates to maintain our strong commercial access, which was partially offset by reduced co-pay program utilization for Emgality and Taltz as a function of improved access versus last year.

    定價對本季度美國收入增長造成 8% 的拖累,主要受回扣和折扣估計變化的影響,最顯著的影響是 Humalog,這主要是受上一期間有利的 Medicaid 調整和本期不利的商業調整推動的;然後在較小程度上,通過較低淨價格段的整個投資組合的更高增長和增加的回扣來維持我們強大的商業准入,這部分被 Emgality 和 Taltz 的共付計劃使用減少所抵消,因為與上次相比,訪問得到改善年。

  • As we've previously discussed, our quarterly pricing trends in the U.S. fluctuate based on delayed invoicing from customers, seasonality of co-pay assistance and our obligations during the coverage gap in Medicare Part D. Excluding the impact of the onetime Humalog adjustment and focusing on trends that impact our business going forward, we saw an underlying pricing trend of low single-digit decline in Q2 versus Q2 2019.

    正如我們之前所討論的,我們在美國的季度定價趨勢會根據客戶延遲開具發票、共同支付援助的季節性以及我們在 Medicare D 部分承保缺口期間的義務而波動。不包括一次性 Humalog 調整和關注的影響在影響我們未來業務的趨勢方面,我們看到與 2019 年第二季度相比,第二季度的潛在定價趨勢為低個位數下降。

  • And this is consistent with our current expectation of mid-single-digit price decline for the year with the underlying low single-digit net price decline combined with onetime adjustments in the first half of 2020 and modest effects of COVID-19 in the second half of the year.

    這與我們目前對今年中個位數價格下跌的預期一致,潛在的低個位數淨價格下跌加上 2020 年上半年的一次性調整和 COVID-19 在下半年的適度影響年。

  • During the first half of 2020, U.S. revenue increased 5% versus last year, volume grew 11% and price declined 6%.

    2020 年上半年,美國收入同比增長 5%,銷量增長 11%,價格下降 6%。

  • We are encouraged by the improving demand trends in recent weeks and more normalized shipping trends.

    最近幾週需求趨勢的改善和更加正常的航運趨勢令我們感到鼓舞。

  • As we conclude 2021 U.S. contracting negotiations, we remain confident in our strong commercial and Medicare Part D access across the portfolio and our ability to maintain this going forward.

    隨著我們結束 2021 年美國合同談判,我們仍然對我們在整個投資組合中強大的商業和醫療保險 D 部分准入以及我們未來保持這一點的能力充滿信心。

  • Moving on to Europe.

    繼續前往歐洲。

  • Revenue declined 4% in constant currency as price and volume declined by 2% each.

    由於價格和數量各下降 2%,按固定匯率計算,收入下降了 4%。

  • Strong volume growth from Trulicity, Verzenio and Taltz was offset by volume declines from Cialis, Forteo, Alimta, Strattera and Humalog.

    Trulicity、Verzenio 和 Taltz 的強勁銷量增長被 Cialis、Forteo、Alimta、Strattera 和 Humalog 的銷量下降所抵消。

  • We estimate European revenue was reduced by approximately $50 million due to COVID-19-related destocking in Q2 and roughly $35 million due to COVID-19-related lower new prescriptions.

    我們估計,由於第二季度與 COVID-19 相關的去庫存,歐洲收入減少了約 5000 萬美元,由於與 COVID-19 相關的新處方減少,減少了約 3500 萬美元。

  • Despite fluctuation across quarters, the underlying trends are very strong as Europe posted volume growth of 11% during the first half of 2020 as our new products continue to scale.

    儘管各季度之間存在波動,但基本趨勢非常強勁,因為隨著我們的新產品繼續擴大規模,歐洲在 2020 年上半年實現了 11% 的銷量增長。

  • In Japan, revenue declined by less than 1% in constant currency as 4% volume growth was more than offset by government-mandated price decreases effective April 2020.

    在日本,按固定匯率計算,收入下降不到 1%,因為 4% 的銷量增長被 2020 年 4 月生效的政府強制降價所抵消。

  • In addition, we estimate reduced new prescriptions due to COVID-19 negatively impacted Q2 revenue by approximately $35 million.

    此外,我們估計,由於 COVID-19 對第二季度收入的負面影響,新處方減少了約 3500 萬美元。

  • The solid volume growth in Verzenio, Trulicity, Olumiant and Cyramza were the key contributors to growth, partially offset by the increased competition for Forteo and the impact of generic Straterra.

    Verzenio、Trulicity、Olumiant 和 Cyramza 的穩健銷量增長是增長的關鍵因素,但部分被 Forteo 競爭加劇和通用 Straterra 的影響所抵消。

  • In China, revenue grew 8% in constant currency driven by 50% volume growth, largely offset by price.

    在中國,在銷量增長 50% 的推動下,按固定匯率計算的收入增長了 8%,但很大程度上被價格所抵消。

  • Volume and price were both affected by the inclusion of Tyvyt and Alimta in government-sponsored programs, which substantially increased access for patients to these important cancer medications.

    數量和價格都受到政府資助項目中 Tyvyt 和 Alimta 的影響,這大大增加了患者獲得這些重要癌症藥物的機會。

  • Outside of the oncology portfolio in China, we saw a rebound in new patient initiations and in-person customer interactions as the pandemic's impact began to moderate.

    在中國的腫瘤學產品組合之外,隨著大流行的影響開始緩和,我們看到新患者的啟動和麵對面的客戶互動出現反彈。

  • Our newest launches, Trulicity, Taltz and Olumiant, are seeing good uptake.

    我們最新推出的 Trulicity、Taltz 和 Olumiant 獲得了良好的應用。

  • And Humalog, Cialis and Cymbalta are again exhibiting solid growth.

    Humalog、Cialis 和 Cymbalta 再次呈現穩健增長。

  • Revenue in the rest of the world increased 7% in constant currency, driven by increased volume from our key growth drivers.

    世界其他地區的收入按固定匯率計算增長了 7%,這得益於我們主要增長動力的銷量增加。

  • Strong performance from Trulicity, Jardiance, Taltz and Verzenio was partially offset by decreased Cialis volume.

    Trulicity、Jardiance、Taltz 和 Verzenio 的強勁表現被 Cialis 銷量下降部分抵消。

  • Revenue was negatively impacted by COVID-related reduced new prescriptions by approximately $25 million, which was more than offset by the sale of a legacy product in Asia.

    收入受到與 COVID 相關的新處方減少約 2500 萬美元的負面影響,這被亞洲傳統產品的銷售所抵消。

  • As shown on Slide 9, our key growth products continue to drive impressive worldwide volume growth.

    如幻燈片 9 所示,我們的主要增長產品繼續推動令人印象深刻的全球銷量增長。

  • These new medicines delivered over 12 percentage points of volume growth this quarter.

    這些新藥在本季度實現了超過 12 個百分點的銷量增長。

  • The strong volume growth -- volume trend in our key products was partially offset by a mix of competition and lower utilization of post-LOE products, Forteo and Cialis, as well as reduced Tradjenta royalties from the restructuring of our alliance with Boehringer Ingelheim that we announced last year.

    強勁的銷量增長——我們主要產品的銷量趨勢被競爭和 LOE 後產品 Forteo 和 Cialis 利用率降低以及我們與勃林格殷格翰重組聯盟導致的 Tradjenta 特許權使用費減少部分抵消。去年宣布。

  • We exit the first half of 2020 pleased with the 16% year-to-date volume growth that our key products have delivered despite a challenging environment.

    儘管環境充滿挑戰,我們的主要產品今年迄今仍實現了 16% 的銷量增長,我們很高興在 2020 年上半年結束。

  • Slide 10 highlights the contributions of our key growth products.

    幻燈片 10 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 54% of revenue.

    這些品牌本季度總共創造了近 30 億美元的收入,佔收入的 54%。

  • While 12% volume growth from key products in Q2 is robust, the negative impact on new patient starts from COVID-19 pandemic and COVID-19-related inventory movements across quarters were a drag on growth in the quarter.

    儘管第二季度主要產品的銷量增長 12% 強勁,但 COVID-19 大流行對新患者的負面影響以及與 COVID-19 相關的跨季度庫存變動拖累了該季度的增長。

  • We expect both of these impacts to be transient, and we are seeing new-to-brand prescriptions recover in June and July.

    我們預計這兩種影響都是暫時的,我們看到新品牌處方在 6 月和 7 月恢復。

  • The underlying business is robust.

    基礎業務穩健。

  • And while COVID-19 has impacted our therapeutic areas differently, our product-specific trends within the market backdrop are strong.

    儘管 COVID-19 對我們的治療領域產生了不同的影響,但我們在市場背景下的產品特定趨勢很強勁。

  • In diabetes, Trulicity remains the market leader in the U.S. GLP-1 market with over 45% share of total prescriptions.

    在糖尿病領域,Trulicity 仍然是美國 GLP-1 市場的市場領導者,佔總處方量的 45% 以上。

  • While new-to-brand prescriptions for the GLP-1 class were 32% less than pre-COVID-19 levels at one point during Q2, activity is trending in the right direction and now sits at around negative 16% for the week ending July 17.

    雖然 GLP-1 類的新品牌處方在第二季度的某個時間點比 COVID-19 之前的水平低 32%,但活動正朝著正確的方向發展,現在截至 7 月的一周約為負 16% 17.

  • Total prescription trends have slowed some but were still robust through the class and grew by 27% in Q2 compared to last year.

    總處方趨勢有所放緩,但在整個課程中仍然強勁,與去年相比在第二季度增長了 27%。

  • As the class leader, Trulicity is well positioned for future growth.

    作為班長,Trulicity 為未來的發展做好了充分的準備。

  • And we look forward to regulatory action later this year on the higher doses of Trulicity.

    我們期待今年晚些時候對更高劑量的 Trulicity 採取監管行動。

  • We expect the potential launch of additional doses to be an important option to allow patients to realize benefits while extending their duration of therapy on Trulicity.

    我們預計額外劑量的潛在推出將是一個重要的選擇,讓患者在延長 Trulicity 治療持續時間的同時實現益處。

  • In another large and fast-growing diabetes class, Jardiance maintained market leadership in the U.S. SGLT2 class with over 57% share of total prescriptions.

    在另一個快速增長的大型糖尿病類別中,Jardiance 在美國 SGLT2 類別中保持市場領先地位,佔總處方量的 57% 以上。

  • The SGLT2 class saw a similar magnitude of reductions as the GLP-1 class in new-to-brand prescriptions as new prescriptions were 38% less than the pre-COVID-19 levels before recovering some in June and July.

    SGLT2 類在新品牌處方中的減少幅度與 GLP-1 類相似,因為新處方比 COVID-19 之前的水平低 38%,然後在 6 月和 7 月恢復了一些。

  • Current weekly trends are approximately 15% below pre-COVID-19 levels.

    當前的每週趨勢比 COVID-19 之前的水平低約 15%。

  • Jardiance continues to be the catalyst for class growth in new and total prescriptions, growing over 12 percentage points faster than the market in Q2 with 32% growth versus last year.

    Jardiance 繼續成為新處方和總處方類別增長的催化劑,第二季度的增長比市場快 12 個百分點,與去年相比增長 32%。

  • We're excited by the recently announced positive results of Jardiance in patients with heart failure in the EMPEROR-Reduced trial and look forward to the EMPEROR-Preserved trial readout in 2021.

    我們對最近宣布的 Jardiance 在 EMPEROR-Reduced 試驗中對心力衰竭患者的積極結果感到興奮,並期待 2021 年 EMPEROR-Preserved 試驗結果。

  • We estimate the addressable market from each trial is up to 3 million additional patients in the U.S., adding a potential new source of future growth for Jardiance.

    我們估計,每項試驗的潛在市場將在美國增加多達 300 萬患者,為 Jardiance 增加了未來增長的潛在新來源。

  • In oncology, Verzenio continues to show positive trends in the metastatic setting as U.S. share of market in new-to-brand prescriptions continued to increase above 20%.

    在腫瘤學方面,隨著美國在新品牌處方中的市場份額繼續增長超過 20%,Verzenio 在轉移性環境中繼續顯示出積極的趨勢。

  • While new-to-brand prescriptions for the CDK4/6 class were more than 30% below pre-COVID levels at one point in the quarter, Verzenio fared better at negative 19%.

    雖然 CDK4/6 類的新品牌處方在本季度的某個時間點比 COVID 之前的水平低 30% 以上,但 Verzenio 的表現更好,為負 19%。

  • And the most recent week of new-to-brand prescriptions is above the pre-COVID-19 average.

    最近一周的新品牌處方高於 COVID-19 之前的平均水平。

  • Verzenio had positive momentum as the monarchE trial results add to the compelling existing data package.

    Verzenio 具有積極的勢頭,因為 monarchE 試驗結果增加了令人信服的現有數據包。

  • We look forward to presenting these data at a medical meeting later this year.

    我們期待在今年晚些時候的醫學會議上展示這些數據。

  • Tyvyt, our immuno-oncology product in collaboration with Innovent in China, posted another strong quarter of performance and was the biggest driver of China's 50% volume growth in Q2.

    Tyvyt 是我們與信達生物在中國合作的免疫腫瘤學產品,該產品又一個季度表現強勁,是中國第二季度銷量增長 50% 的最大推動力。

  • Tyvyt was added to the National Drug Reimbursement List in January this year.

    Tyvyt 於今年 1 月被列入國家藥品報銷清單。

  • And we anticipate strong sales momentum in the second half of 2020.

    我們預計 2020 年下半年的銷售勢頭強勁。

  • We expect Tyvyt to continue to be an important driver of growth in China.

    我們預計 Tyvyt 將繼續成為中國增長的重要推動力。

  • Our newest oncology medicine, Retevmo, had a strong launch despite debuting during a challenging external environment.

    儘管在充滿挑戰的外部環境中首次亮相,但我們最新的腫瘤藥物 Retevmo 仍然強勁推出。

  • We're encouraged by early demand signals.

    我們對早期的需求信號感到鼓舞。

  • And initial customer feedback on the impressive safety and efficacy profile is very positive.

    客戶對令人印象深刻的安全性和有效性概況的初步反饋非常積極。

  • Our sales force and medical science liaisons are actively engaging with 6,000 lung and thyroid specialists through virtual tactics.

    我們的銷售人員和醫學科學聯絡員正在通過虛擬策略與 6,000 名肺和甲狀腺專家積極接觸。

  • And our existing relationships with this customer base are leading to high-quality interactions and increased brand awareness for this first-in-class medicine.

    我們與該客戶群的現有關係正在為這種一流的藥物帶來高質量的互動並提高品牌知名度。

  • While still early in the launch, we're excited about the fast start and continue to believe we have a best-in-class product.

    雖然仍處於發布初期,但我們對快速啟動感到興奮,並繼續相信我們擁有一流的產品。

  • In immunology, we saw strong new-to-brand trends with Taltz early in Q1, followed by a sizable but more gradual impact of COVID-19.

    在免疫學方面,我們在第一季度初看到了 Taltz 的強勁新品牌趨勢,隨後 COVID-19 產生了相當大但更漸進的影響。

  • Compared to pre-COVID levels, new-to-brand prescriptions across immunology declined 36%.

    與 COVID 之前的水平相比,免疫學領域的新品牌處方下降了 36%。

  • While this category has also been slower to recover, the most recent weeks have showed improvements in trends.

    雖然這一類別的恢復速度也較慢,但最近幾週的趨勢有所改善。

  • However, new-to-brand prescriptions for the total market are still 21% below pre-COVID levels.

    但是,整個市場的新品牌處方仍比 COVID 之前的水平低 21%。

  • Taltz continues to compete for leadership in dermatology new-to-brand share of market.

    Taltz 繼續爭奪皮膚科新品牌市場份額的領導地位。

  • And rheumatology trends are encouraging, although growing from a smaller base.

    風濕病學趨勢令人鼓舞,儘管基數較小。

  • Total Taltz prescriptions grew 11% in Q2 compared to Q1 and 35% versus Q2 2019.

    與第一季度相比,第二季度的 Taltz 處方總量增長了 11%,與 2019 年第二季度相比增長了 35%。

  • We remain confident that our compelling data package of head-to-head trials and recent approval in non-radiographic axSpA will deliver growth in a competitive field of immunology agents.

    我們仍然相信,我們令人信服的頭對頭試驗數據包和最近在非放射學 axSpA 中的批准將在競爭激烈的免疫學藥物領域實現增長。

  • In migraine, we've also seen a more prolonged decline in new-to-brand prescriptions due to COVID-19.

    在偏頭痛中,由於 COVID-19,我們還看到新品牌處方的下降時間更長。

  • New-to-brand prescriptions in the injectable CGRP class have been 15% to 20% below pre-COVID levels since late April and through July.

    自 4 月下旬至 7 月,注射用 CGRP 類的新品牌處方比 COVID 之前的水平低 15% 至 20%。

  • Emgality's share of market remains strong with over 38% of new and total prescriptions within the class.

    Emgality 的市場份額仍然強勁,該類別中超過 38% 的新處方和總處方。

  • Although new-to-brand trends have been impacted by COVID-19, class growth for total prescriptions was robust in Q2, increasing 64% compared to last year and 12% versus Q1 2020.

    儘管新品牌趨勢受到 COVID-19 的影響,但第二季度總處方的類別增長強勁,與去年相比增長 64%,與 2020 年第一季度相比增長 12%。

  • Given the importance of primary care physicians in driving growth with the return of active promotions from multiple competitors, we expect class growth to reaccelerate in the second half of 2020.

    鑑於初級保健醫生在多個競爭對手的積極促銷回歸推動增長方面的重要性,我們預計類別增長將在 2020 年下半年重新加速。

  • Also in migraine, our acute therapy, Reyvow, was significantly impacted by the lack of patient visits and in-person customer interactions related to COVID-19.

    同樣在偏頭痛方面,我們的急性療法 Reyvow 因缺乏與 COVID-19 相關的患者就診和麵對面的客戶互動而受到顯著影響。

  • While uptake so far has been modest early in the launch, we'll make investments to drive awareness and focus our promotional efforts in the coming quarters to drive uptake.

    雖然到目前為止在發布初期的吸收量不大,但我們將進行投資以提高知名度,並在未來幾個季度集中我們的促銷工作來推動吸收。

  • While the field is competitive, we continue to believe our portfolio of both acute and preventative treatments with 2 mechanisms of action is a differentiator for our migraine franchise.

    儘管該領域具有競爭力,但我們仍然相信,我們具有兩種作用機制的急性和預防性治療組合是我們偏頭痛專營權的差異化因素。

  • On Slide 11, we provide an update on capital allocation.

    在幻燈片 11 中,我們提供了資本配置的最新信息。

  • During the first half of 2020, we invested over $4 billion to drive our future growth through a combination of business development, capital expenditures and after-tax investment in R&D.

    在 2020 年上半年,我們投資了超過 40 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 almost $2 billion to shareholders versus share repurchase -- via share repurchase and the dividend.

    此外,與股票回購相比,我們通過股票回購和股息向股東返還了近 20 億美元。

  • We remain well capitalized and have the ability to access debt markets at attractive rates.

    我們仍然資本充足,有能力以有吸引力的利率進入債務市場。

  • We expect to continue to enhance our long-term growth by acquiring first- or best-in-class pipeline assets and do not anticipate COVID impacts regarding travel or market uncertainty to affect our efforts.

    我們希望通過收購一流或一流的管道資產來繼續增強我們的長期增長,並且預計 COVID 對旅行或市場不確定性的影響不會影響我們的努力。

  • Before we provide an update on our 2020 financial guidance, Slide 12 provides an overview of the composition of our U.S. business split by payer segment mix.

    在我們提供 2020 年財務指導的更新之前,幻燈片 12 概述了我們按付款人細分組合劃分的美國業務的構成。

  • This is a topic of frequent interest to investors and is pertinent as we monitor the currently high levels of unemployment and the potential for that to negatively impact our business.

    這是投資者經常感興趣的一個話題,並且在我們監控目前的高失業率以及這對我們的業務產生負面影響的可能性時是相關的。

  • Based on gross sales during the first half of 2020, within our existing business, commercial plans make up the largest portion at around 40%.

    根據 2020 年上半年的總銷售額,在我們現有的業務中,商業計劃佔最大比例,約為 40%。

  • Medicare Part D is the second largest segment at approximately 20%, mainly due to our diabetes portfolio.

    醫療保險 D 部分是第二大細分市場,約佔 20%,主要是由於我們的糖尿病產品組合。

  • Government and hospital segments make up roughly 15%.

    政府和醫院部門約佔 15%。

  • Medicaid is around 10%.

    醫療補助約為 10%。

  • Medicare Part B is nearly 5%.

    醫療保險 B 部分接近 5%。

  • And then non-contracted business, uninsured and cash make up the remaining 10%.

    然後是非合同業務、無保險和現金構成剩餘的 10%。

  • So as we continue to monitor and analyze the potential impact of unemployment, causing people to lose their commercial insurance and potentially shift to Medicaid, our modeling suggests this will have a modest impact in 2020 and is contemplated in our financial guidance range.

    因此,隨著我們繼續監測和分析失業的潛在影響,導致人們失去商業保險並可能轉向醫療補助,我們的模型表明這將在 2020 年產生適度影響,並在我們的財務指導範圍內進行考慮。

  • We expect these trends to have a larger impact in 2021.

    我們預計這些趨勢將在 2021 年產生更大的影響。

  • And the magnitude will be driven by: the size and duration of unemployment in the U.S.; the quality of commercial or ACA exchange insurance plans displaced employees move from; the majority of our product as newer products have smaller net pricing spread between Medicaid and commercial plans; and government stimulus or release plans that may keep patients on commercial insurance.

    其規模將由以下因素驅動:美國失業的規模和持續時間;被解僱的員工搬離的商業或 ACA 交換保險計劃的質量;作為較新產品,我們的大部分產品在醫療補助計劃和商業計劃之間的淨定價差距較小;政府刺激或發布計劃可能使患者繼續購買商業保險。

  • While there is uncertainty on how all these factors will play out, at this time, we anticipate increased utilization of Medicaid versus commercial insurance to be a moderate headwind to revenue in 2021 of approximately $200 million.

    雖然所有這些因素將如何發揮作用都存在不確定性,但目前,我們預計醫療補助與商業保險的使用增加將成為 2021 年約 2 億美元收入的適度逆風。

  • This approximation contemplates peak U.S. unemployment in the low double digits in 2020 and a gradual recovery in 2021 to high single-digit percent unemployed by year-end.

    這一近似值預計美國失業率將在 2020 年達到兩位數的峰值,並在 2021 年逐步恢復到年底的高個位數百分比失業率。

  • We do not have an estimate on the impact of the executive orders on 2021 at this point.

    我們目前還沒有關於行政命令對 2021 年的影響的估計。

  • But given the uncertainty around them and our modest exposure to Part B, we expect the near-term impact to be limited.

    但鑑於圍繞它們的不確定性以及我們對 B 部分的適度敞口,我們預計短期影響將是有限的。

  • Given our view of 2021 pricing negotiations, we still expect mid-single-digit price impacts across the portfolio in 2021.

    鑑於我們對 2021 年定價談判的看法,我們仍預計 2021 年整個投資組合的價格影響將達到中等個位數。

  • So now moving to Slide 13.

    所以現在轉到幻燈片 13。

  • 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.

    這是基於我們目前的最佳估計。

  • And similar to how we approach Q1, we're balancing transparency and insight into the current view of the business with the uncertainty we're all facing surrounding the extent and duration of the impact of the COVID-19 pandemic.

    與我們處理第一季度的方式類似,我們正在平衡透明度和對當前業務視圖的洞察力與我們都面臨的圍繞 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: health care activity returns to normal levels in the second half of 2020 as doctors utilize telehealth or in-person visits to see patients despite potential additional COVID-19 outbreaks; the recovery in new patient prescriptions improves in the U.S., reaching and then growing above pre-COVID-19 levels by Q4 for most brands, noting the trends will differ regionally and by brand; price headwinds from increased utilization of patient affordability programs and changes in segment mix due to increased U.S. unemployment continue to be modest; clinical trial sites remain open and active in enrolling patients; and promotional spend in the second half of the year constitutes a mix of in-person customer interactions, direct-to-consumer advertising and investments in supporting digital promotion.

    支持我們更新指南的關鍵假設包括:儘管可能出現更多 COVID-19 疫情,但由於醫生利用遠程醫療或親自就診看病,醫療保健活動將在 2020 年下半年恢復正常水平;在美國,新患者處方的恢復有所改善,大多數品牌在第四季度達到並高於 COVID-19 之前的水平,並指出趨勢會因地區和品牌而異;患者負擔能力計劃的使用增加以及美國失業率增加導致的細分市場變化帶來的價格逆風繼續溫和;臨床試驗地點保持開放並積極招募患者;今年下半年的促銷支出包括面對面的客戶互動、直接面向消費者的廣告和支持數字促銷的投資。

  • While uncertainty remains regarding the continued spread of COVID-19 and the resulting impact on the pace of economic recovery around the world, we believe health care activity will continue to be a priority and the patients and physicians will find ways to access health care.

    儘管 COVID-19 的持續傳播及其對全球經濟復甦步伐的影響仍存在不確定性,但我們相信醫療保健活動將繼續成為優先事項,患者和醫生將找到獲得醫療保健的途徑。

  • We believe the stocking and destocking activity observed in Q1 and Q2 had largely washed out.

    我們認為第一季度和第二季度觀察到的庫存和去庫存活動已基本消失。

  • And we are encouraged by the demand trends and more normal shipping patterns we're seeing with our customers.

    我們對客戶的需求趨勢和更正常的運輸模式感到鼓舞。

  • As a result, we're maintaining our revenue range, recognizing additional closures in the health care system could cause us to revisit that range later in the year.

    因此,我們正在維持我們的收入範圍,認識到醫療保健系統的額外關閉可能會導致我們在今年晚些時候重新審視這個範圍。

  • Moving down the income statement.

    向下移動損益表。

  • We're lowering our gross margin as a percent of revenue to be approximately 80% on a non-GAAP basis.

    在非公認會計原則的基礎上,我們將毛利率作為收入的百分比降低到大約 80%。

  • This reduction reflects changes in geographic mix and lower realized prices.

    這種減少反映了地域組合的變化和較低的實際價格。

  • We expect our GAAP gross margin to be 78%.

    我們預計我們的 GAAP 毛利率為 78%。

  • We're also lowering our range for marketing, selling and administrative expenses by $200 million to reflect savings from reduced travel meetings and in-person promotional activities, which are only partially offset by investments in digital capabilities.

    我們還將營銷、銷售和管理費用範圍降低了 2 億美元,以反映旅行會議和麵對面促銷活動減少所節省的費用,這些費用僅部分被數字能力投資所抵消。

  • Our range for research and development expenses is unchanged.

    我們的研發費用範圍保持不變。

  • We expect savings associated with temporary pausing of clinical trial starts and enrollment to catch up in the second half of 2020 as we resumed activity in Q2.

    隨著我們在第二季度恢復活動,我們預計與臨時暫停臨床試驗開始和註冊相關的節省將在 2020 年下半年趕上。

  • Of note, if we see positive data in our neutralizing antibody treatments for COVID-19 that supports broader development, we plan to fully invest in registrational clinical trials and further scaling of manufacturing capacity.

    值得注意的是,如果我們在 COVID-19 中和抗體治療中看到支持更廣泛發展的積極數據,我們計劃全面投資於註冊臨床試驗並進一步擴大生產能力。

  • Under this scenario, our research and development expenses are likely to be in the high end of our range as Lilly is self-funding all of these programs.

    在這種情況下,我們的研發費用可能處於我們範圍的高端,因為禮來公司自籌資金所有這些項目。

  • We believe these investments are important to help combat the impact of the global pandemic.

    我們認為,這些投資對於幫助應對全球大流行的影響非常重要。

  • Our non-GAAP operating income as a percent of revenue goal of 31% remains as a reduction in total operating expenses offset the slightly lower gross margin percentage.

    我們的非美國通用會計準則營業收入佔收入目標的百分比為 31%,因為總營業費用的減少抵消了毛利率略低的百分比。

  • We're updating the range for other income and expense to $350 million to $500 million of income, reflecting gains in our equity portfolio seen in the second quarter.

    我們將其他收入和支出的範圍更新為 3.5 億美元至 5 億美元的收入,反映了第二季度我們股票投資組合的收益。

  • As I mentioned earlier, this number is, of course, subject to volatility in the capital markets.

    正如我之前提到的,這個數字當然會受到資本市場波動的影響。

  • Turning to taxes.

    轉向稅收。

  • We're reducing our GAAP and non-GAAP effective tax rate guidance to approximately 14%, driven by the net discrete tax benefits we booked for the first half of the year.

    由於我們在上半年預訂的淨離散稅收優惠,我們正在將我們的 GAAP 和非 GAAP 有效稅率指導降低至約 14%。

  • So earnings per share is now expected to be in the range of $7.20 per share to $7.40 per share on a non-GAAP basis.

    因此,按非公認會計原則計算,現在預計每股收益在每股 7.20 美元至 7.40 美元之間。

  • Our GAAP EPS is expected to be in the range of $6.48 per share to $6.68 per share.

    我們的公認會計原則每股收益預計在每股 6.48 美元至 6.68 美元之間。

  • Q2 was certainly an atypical quarter.

    第二季度當然是一個非典型的季度。

  • As I highlighted earlier, COVID impacted our financial results in a number of ways.

    正如我之前強調的那樣,COVID 以多種方式影響了我們的財務業績。

  • However, our confidence in the strength of our underlying business and our demonstrated ability to overcome challenges gives us the conviction to reaffirm our robust outlook for sales growth and productivity.

    然而,我們對基礎業務實力的信心以及我們克服挑戰的能力使我們有信心重申我們對銷售增長和生產力的強勁前景。

  • So I'll now turn the call over to Dan to provide an update on our ongoing efforts to develop treatments for COVID-19, a summary of key data disclosures in Q2 and a pipeline update.

    因此,我現在將電話轉給 Dan,以提供我們正在開發 COVID-19 治療方法的最新信息、第二季度關鍵數據披露的摘要和管道更新。

  • 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, Josh.

    謝謝,喬希。

  • Since our last call, we've had major life cycle readouts for 3 of our most important new medicines: Verzenio, Trulicity and Jardiance.

    自上次電話會議以來,我們已經獲得了 3 種最重要的新藥的主要生命週期讀數:Verzenio、Trulicity 和 Jardiance。

  • All 3 were positive, all represent clinically meaningful advances for patients and all should help drive continued growth for these important brands.

    所有 3 項都是積極的,都代表了對患者俱有臨床意義的進步,都應該有助於推動這些重要品牌的持續增長。

  • I'll speak briefly about each as well as a Phase III readout for mirikizumab, a molecule still under development.

    我將簡要介紹每一個以及 mirikizumab 的 III 期讀數,這是一種仍在開發中的分子。

  • In addition to advancing our existing R&D portfolio, we have devoted significant efforts to creating and testing potential therapies for COVID-19.

    除了推進我們現有的研發組合外,我們還投入了大量精力來創建和測試 COVID-19 的潛在療法。

  • And here, too, we have made good progress this quarter.

    在這方面,我們本季度也取得了良好進展。

  • Before I go through the pipeline update, I'll provide an update on our COVID-19 therapies.

    在完成管道更新之前,我將提供有關我們 COVID-19 療法的更新。

  • Moving to Slide 14.

    轉到幻燈片 14。

  • We provide an overview of the active programs we're pursuing to treat or prevent COVID-19.

    我們概述了我們正在尋求治療或預防 COVID-19 的積極計劃。

  • These programs have moved with unprecedented speed in hopes of finding new medicines to help blunt the impact of the virus.

    這些項目以前所未有的速度推進,希望找到新的藥物來幫助減輕病毒的影響。

  • Baricitinib, our JAK inhibitor, has 2 ongoing Phase III clinical trials in patients hospitalized with COVID-19.

    我們的 JAK 抑製劑 Baricitinib 正在進行 2 項針對 COVID-19 住院患者的 III 期臨床試驗。

  • The anti-inflammatory activity observed by baricitinib in other diseases is thought to be potentially beneficial in treating COVID-19.

    baricitinib 在其他疾病中觀察到的抗炎活性被認為可能對治療 COVID-19 有益。

  • The first trial is investigating baricitinib in combination with remdesivir as part of the NIAID Adaptive COVID-19 Treatment Trial.

    第一項試驗是作為 NIAID 適應性 COVID-19 治療試驗的一部分,研究 baricitinib 與 remdesivir 的組合。

  • And we expect to have data from this trial within the coming months.

    我們預計在未來幾個月內將獲得該試驗的數據。

  • The second trial is Lilly-sponsored and is assessing baricitinib as monotherapy.

    第二項試驗由禮來公司贊助,正在評估巴瑞替尼作為單一療法。

  • We expect results from this trial later this year.

    我們預計今年晚些時候該試驗的結果。

  • Second, we're pursuing a Phase II trial of an antibody that targets Angiopoietin-2, which has been observed to be elevated in patients with acute respiratory distress syndrome or ARDS.

    其次,我們正在進行一項針對血管生成素-2的抗體的 II 期試驗,該抗體已被觀察到在急性呼吸窘迫綜合徵或 ARDS 患者中升高。

  • Based on trial enrollment, we now expect to have data in-house this fall to inform next steps.

    根據試驗註冊情況,我們現在預計今年秋天將在內部獲得數據,為下一步提供信息。

  • While these 2 efforts may inform treatment of the symptoms of COVID-19, the approach I'm most excited about is virus-neutralizing antibodies for the treatment and prevention of COVID-19, both as single-antibody therapies and in combinations.

    雖然這兩項努力可能會為 COVID-19 症狀的治療提供信息,但我最興奮的方法是用於治療和預防 COVID-19 的病毒中和抗體,既可以作為單一抗體療法,也可以作為組合療法。

  • We currently have efforts ongoing with LY-CoV555, which arose from our collaboration with AbCellera; and with LY-CoV016, which we licensed from Junshi Biosciences.

    我們目前正在與 LY-CoV555 合作,這源於我們與 AbCelera 的合作;以及我們從 Junshi Biosciences 獲得許可的 LY-CoV016。

  • The development status is summarized on Slide 15.

    幻燈片 15 總結了開發狀態。

  • Both antibodies have completed dosing in their Phase I studies with safety and PK results that support advancing the molecules.

    兩種抗體均已在其 I 期研究中完成給藥,其安全性和 PK 結果支持推進分子。

  • Neither Phase I study was designed to collect efficacy data as the 555 trial only enrolled 6 patients per dose and 016 enrolled only healthy volunteers.

    兩項 I 期研究均未設計用於收集療效數據,因為 555 試驗每劑僅招募 6 名患者,016 僅招募健康志願者。

  • 555 is further along in development and has progressed to a large dose-ranging Phase II study in ambulatory patients recently diagnosed with COVID-19.

    555正在進一步開發中,並已在最近被診斷出患有 COVID-19 的門診患者中進行大劑量範圍的 II 期研究。

  • Here, we are focused on reducing viral load.

    在這裡,我們專注於減少病毒載量。

  • The study is enrolling quickly, and we should have data to report by Q4.

    該研究正在迅速招募,我們應該在第四季度有數據要報告。

  • This will be our first opportunity to share human efficacy data from the neutralizing antibody program.

    這將是我們第一次有機會分享來自中和抗體計劃的人體功效數據。

  • Based on safety and tolerability data gathered to date as well as taking into account the gravity of the unmet medical need here, we plan to initiate registrational studies in the coming weeks, even in advance of having efficacy data.

    基於迄今為止收集的安全性和耐受性數據,並考慮到此處未滿足的醫療需求的嚴重性,我們計劃在未來幾週內啟動註冊研究,甚至在獲得療效數據之前。

  • We envision studies across several different patient populations, including a Phase III study for prevention of COVID-19 in residents and staff at long-term care facilities as well as additional registrational studies for a potential treatment indication in both the ambulatory and hospitalized settings.

    我們設想對幾個不同的患者群體進行研究,包括一項針對長期護理機構的居民和工作人員預防 COVID-19 的 III 期研究,以及針對門診和住院環境中潛在治療適應症的額外註冊研究。

  • Once underway, the timing for data disclosures from these trials will be highly dependent on patient enrollment and any interim efficacy and safety data we may see.

    一旦開始,這些試驗的數據披露時間將在很大程度上取決於患者登記以及我們可能看到的任何中期療效和安全性數據。

  • In addition to the monotherapy trials I described for 555, we intend to test the combination of 016 with 555 in case such a combination is needed to combat viral resistance.

    除了我為 555 描述的單一療法試驗外,我們還打算測試 016 與 555 的組合,以防需要這種組合來對抗病毒耐藥性。

  • We look forward to producing additional data for both programs.

    我們期待為這兩個項目提供更多數據。

  • And we'll provide updates as we achieve program milestones or data become available.

    當我們實現計劃里程碑或數據可用時,我們將提供更新。

  • We continue to invest in manufacturing for these potential therapies at risk.

    我們繼續投資於這些潛在療法的製造風險。

  • And we're focused on ramping up our manufacturing capacity as quickly as possible.

    我們專注於盡快提高我們的製造能力。

  • While developing treatments for COVID-19 is an important priority for Lilly right now, we also continue to advance the rest of our pipeline to help people with diabetes, immune disorders, neurodegeneration and cancer.

    雖然開發 COVID-19 的治療方法是禮來目前的一個重要優先事項,但我們還繼續推進我們的其餘產品線,以幫助患有糖尿病、免疫疾病、神經退行性疾病和癌症的人。

  • One particularly exciting development this quarter was the positive interim readout of the monarchE trial, assessing the use of Verzenio to reduce the risk of recurrence in HR-positive, HER2-negative, high-risk early breast cancer.

    本季度一個特別令人興奮的進展是 monarchE 試驗的陽性中期讀數,評估使用 Verzenio 降低 HR 陽性、HER2陰性、高風險早期乳腺癌的複發風險。

  • Verzenio is the only CDK4/6 inhibitor to show a benefit in this setting, where another competing product failed at a futility analysis.

    Verzenio 是唯一在這種情況下顯示出益處的 CDK4/6 抑製劑,而另一種競爭產品在無效分析中失敗了。

  • Our conviction in the differentiation of Verzenio from the competition continues to increase based on important data, including: safety and tolerability data and mechanism of action that have allowed for continuous dosing and therefore continuous target inhibition, this is a unique feature of abemaciclib; clinical efficacy that supports use even as a monotherapy in metastatic breast cancer, another unique feature of abemaciclib; the demonstrated benefit in overall survival in the metastatic setting in combination with fulvestrant, something not all CDK4/6 inhibitors have been able to show; and most recently, positive results in the adjuvant setting, another unique feature of abemaciclib.

    基於重要數據,我們對 Verzenio 從競爭中脫穎而出的信念不斷增強,包括:安全性和耐受性數據以及允許連續給藥並因此連續靶點抑制的作用機制,這是 abemaciclib 的獨特特徵;臨床療效甚至支持作為轉移性乳腺癌的單一療法使用,這是 abemaciclib 的另一個獨特特徵;與氟維司群聯合在轉移性環境中的總生存期顯示出的益處,並非所有 CDK4/6 抑製劑都能夠顯示出來;最近,在輔助治療方面取得了積極成果,這是 abemaciclib 的另一個獨特功能。

  • These data continue to support our convictions that not all CDK4/6 inhibitors are the same.

    這些數據繼續支持我們的信念,即並非所有 CDK4/6 抑製劑都是相同的。

  • The positive results in monarchE could significantly increase the opportunity for Verzenio.

    monarchE 的積極結果可能會顯著增加 Verzenio 的機會。

  • Looking at the monarchE study clinical pathological criteria for enrollment.

    看著 monarchE 研究的臨床病理標准入組。

  • We estimate that approximately 20,000 patients in the U.S. would match these criteria.

    我們估計美國約有 20,000 名患者符合這些標準。

  • This represents a roughly 50% increase over the current addressable market in metastatic breast cancer, a market projected to reach almost $7 billion in 2020.

    這比目前的轉移性乳腺癌潛在市場增長了約 50%,預計 2020 年該市場將達到近 70 億美元。

  • In addition, we anticipate duration of therapy in the adjuvant setting will be longer.

    此外,我們預計輔助環境中的治療持續時間會更長。

  • We plan to submit these data by the end of the year to regulators around the world and to present them at a major medical meeting in 2020.

    我們計劃在今年年底前將這些數據提交給世界各地的監管機構,並在 2020 年的一次重大醫學會議上展示。

  • Moving to Slide 17.

    轉到幻燈片 17。

  • We also presented important Trulicity data at the virtual ADA and ENDO meetings this summer.

    我們還在今年夏天的虛擬 ADA 和 ENDO 會議上展示了重要的 Trulicity 數據。

  • In the on-treatment analysis, the 3-milligram and 4.5-milligram doses of Trulicity demonstrated statistically significant improvement in hemoglobin A1c reduction and weight loss versus the currently approved 1.5-milligram dose at 36 weeks.

    在治療分析中,與目前批准的 1.5 毫克劑量相比,Trulicity 的 3 毫克和 4.5 毫克劑量在 36 週時顯示出在血紅蛋白 A1c 減少和體重減輕方面具有統計學意義的改善。

  • These doses could allow patients to receive additional clinical benefits and stay on Trulicity while still experiencing Trulicity's ease of use.

    這些劑量可以讓患者獲得額外的臨床益處並繼續使用 Trulicity,同時仍然體驗 Trulicity 的易用性。

  • We look forward to U.S. and EU regulatory action on the additional doses of Trulicity later this year.

    我們期待今年晚些時候美國和歐盟對額外劑量的 Trulicity 採取監管行動。

  • At the virtual ADA, we also shared data which builds upon the existing body of evidence demonstrating the simplicity of the Trulicity patient experience combined with its powerful efficacy.

    在虛擬 ADA 中,我們還共享了基於現有證據的數據,這些證據證明了 Trulicity 患者體驗的簡單性及其強大的功效。

  • In this real-world analysis of patients, after a minimum of 6 months of follow-up in the U.S., Trulicity demonstrated significantly higher adherence and persistence compared to 2 other weekly GLP-1s.

    在這項對患者的真實世界分析中,在美國進行了至少 6 個月的隨訪後,與其他 2 個每週 GLP-1 相比,Trulicity 表現出顯著更高的依從性和持久性。

  • In addition, significantly fewer people discontinued treatment on Trulicity compared to other agents.

    此外,與其他藥物相比,停止使用 Trulicity 治療的人數明顯減少。

  • This real-world evidence complements the robust clinical data generated for Trulicity and provides further support for why Trulicity is the market-leading GLP-1.

    這一真實世界的證據補充了為 Trulicity 生成的強大臨床數據,並進一步支持了為什麼 Trulicity 是市場領先的 GLP-1。

  • Moving to Slide 18.

    轉到幻燈片 18。

  • You can see our select pipeline opportunities as of July 23.

    截至 7 月 23 日,您可以查看我們精選的管道機會。

  • Movements since our last earnings call includes the previously mentioned U.S. approvals for Lyumjev, Retevmo and Tauvid; the U.S. approval of Taltz for non-radiographic axSpA, and Cyramza for EGFR mutated non-small cell lung cancer; the initiation of the Phase III tirzepatide cardiovascular outcome study, SURPASS-CVOT; the advancement of 3 new Phase II programs; the initiation of 3 Phase I programs; and the attrition of our first-generation KRAS G12C molecule.

    自上次財報電話會議以來的變動包括前面提到的美國對 Lyumjev、Retevmo 和 Tauvid 的批准;美國批准 Taltz 用於非放射學 axSpA 和 Cyramza 用於 EGFR 突變的非小細胞肺癌;啟動 III 期 tirzepatide 心血管結局研究 SURPASS-CVOT;推進 3 個新的第二階段計劃;啟動 3 個第一階段計劃;以及我們的第一代 KRAS G12C 分子的損耗。

  • While we were excited about our initial KRAS program, we observed unexpected toxicity in the clinic that precluded further development.

    雖然我們對我們最初的 KRAS 計劃感到興奮,但我們在診所觀察到意外的毒性,阻礙了進一步的發展。

  • We're working to understand the mechanistic basis for the toxicity, and we are exploring a backup program.

    我們正在努力了解毒性的機制基礎,我們正在探索一個備用程序。

  • Moving to Slide 19.

    轉到幻燈片 19。

  • We provided an update on our 2020 key events that have occurred during the quarter.

    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, initiations and pipeline progress, we submitted Olumiant in the U.S. for atopic dermatitis.

    除了前面提到的批准、啟動和管道進展外,我們還在美國提交了用於特應性皮炎的 Olumiant。

  • As Dave mentioned earlier, we also announced positive Phase III readouts for Jardiance in heart failure and mirikizumab in psoriasis.

    正如 Dave 之前提到的,我們還宣布了 Jardiance 治療心力衰竭和 mirikizumab 治療銀屑病的積極 III 期讀數。

  • Beginning with Jardiance.

    從 Jardiance 開始。

  • We were optimistic about the likelihood of success in heart failure based on compelling CV data seen in diabetic patients in the EMPA-REG OUTCOME trial.

    根據 EMPA-REG OUTCOME 試驗中糖尿病患者的令人信服的 CV 數據,我們對心力衰竭成功的可能性持樂觀態度。

  • We were pleased to see a positive outcome from the first heart failure trial to read out EMPEROR-Reduced.

    我們很高興看到第一個心力衰竭試驗的積極結果讀出了 EMPEROR-Reduced。

  • And we will present the data in August at the European Society of Cardiology and submit to regulators later this year.

    我們將在 8 月份在歐洲心髒病學會上展示這些數據,並在今年晚些時候提交給監管機構。

  • We look forward to additional Jardiance data readouts, including heart failure with preserved ejection fraction, the EMPEROR-Preserved trial, in 2021; and chronic kidney disease, the EMPA-KIDNEY study, in 2022.

    我們期待更多的 Jardiance 數據讀數,包括 2021 年保留射血分數的心力衰竭,即 EMPEROR-Preserved 試驗;和慢性腎病,EMPA-KIDNEY 研究,2022 年。

  • We also announced a positive readout for mirikizumab Phase III in psoriasis, including success on the primary and all key secondary endpoints.

    我們還宣布了銀屑病 mirikizumab III 期的積極讀數,包括主要和所有關鍵次要終點的成功。

  • It's particularly encouraging to see such robust data from mirikizumab in a head-to-head trial since trials such as these are the gold standard for comparing agents.

    在頭對頭試驗中看到來自 mirikizumab 的如此強大的數據尤其令人鼓舞,因為諸如此類的試驗是比較藥物的黃金標準。

  • Indeed, we've had a number of positive head-to-head trials with Taltz in psoriasis.

    事實上,我們已經與 Taltz 在銀屑病中進行了許多正面的正面對比試驗。

  • And now we're pleased to see mirikizumab demonstrate superiority versus Cosentyx at 52 weeks on both PASI 90 and PASI 100.

    現在我們很高興看到 mirikizumab 在 52 週時在 PASI 90 和 PASI 100 上都表現出優於 Cosentyx 的優勢。

  • Despite growing competition in psoriasis, Taltz remains an excellent option for patients that delivers clear skin fast.

    儘管銀屑病競爭日益激烈,但 Taltz 仍然是快速提供透明皮膚的患者的絕佳選擇。

  • These new data suggest that mirikizumab also has the potential to be a meaningful treatment for people living with psoriasis.

    這些新數據表明,mirikizumab 也有可能成為對銀屑病患者有意義的治療方法。

  • We look forward to submitting mirikizumab in this indication.

    我們期待在此適應症中提交 mirikizumab。

  • And importantly, these data further our conviction in IBD, where we see the biggest opportunity.

    重要的是,這些數據進一步加深了我們對 IBD 的信念,我們看到了最大的機會。

  • Given the relative priority of indications, we've been staging our investments in psoriasis.

    鑑於適應症的相對優先級,我們一直在對銀屑病進行投資。

  • We have worked on going to prepare for the psoriasis submission and plan to submit in the second half of 2021.

    我們已經著手準備銀屑病提交,併計劃在 2021 年下半年提交。

  • Accordingly, we've also provided an updated time line for the Phase III data of mirikizumab in ulcerative colitis and Crohn's disease.

    因此,我們還提供了 mirikizumab 在潰瘍性結腸炎和克羅恩病中的 III 期數據的更新時間線。

  • We now expect the top line results for induction for ulcerative colitis in the spring of 2021 and for Crohn's disease in 2022.

    我們現在預計 2021 年春季潰瘍性結腸炎誘導和 2022 年克羅恩病誘導的一線結果。

  • Since we announced the pause of new trial starts and enrollment in many programs back in March, I'm pleased to report that we've reopened enrollment in the vast majority of clinical trials, and we are again initiating new trials.

    自從我們在 3 月份宣布暫停新的試驗開始和許多項目的註冊以來,我很高興地報告,我們已經重新開放了絕大多數臨床試驗的註冊,並且我們正在再次啟動新的試驗。

  • As we partner with clinical trial sites going forward, we've made a number of changes to how we run clinical trials that allowed for many tests to be completed virtually.

    隨著我們與臨床試驗站點的合作,我們對運行臨床試驗的方式進行了許多更改,從而可以虛擬完成許多測試。

  • These new capabilities have come from necessity but are also improvements on the way clinical research is conducted and something we'll continue going forward.

    這些新功能來自必要性,但也是對臨床研究進行方式的改進,我們將繼續前進。

  • These are challenging times in drug development.

    這些是藥物開發的挑戰時期。

  • But Lilly has demonstrated we have the creativity to adapt to the new environment, and we're committed to bringing new medicines to patients.

    但禮來已經證明我們有適應新環境的創造力,我們致力於為患者帶來新藥。

  • Dave, back to you for some closing remarks.

    戴夫,回來給你一些閉幕詞。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Thanks, Dan.

    謝謝,丹。

  • While mobilizing our resources to pursue treatments of devastating diseases is a natural part of our history and our company's purpose, on a separate note, I think all major employers are realizing we have a bigger role to play in the fight against systemic racial injustice.

    雖然調動我們的資源來治療毀滅性疾病是我們歷史和公司宗旨的自然組成部分,但另一方面,我認為所有主要雇主都意識到我們在打擊系統性種族不公正方面可以發揮更大的作用。

  • And as a corporate leader in diversity inclusion, Lilly is committed to using our platform to speak up, speak out and work towards solutions to eliminate the racism and inequities that African-Americans and other minorities have experienced for far too long.

    作為多元化包容的企業領導者,禮來致力於利用我們的平台發聲、暢所欲言並努力尋求解決方案,以消除非洲裔美國人和其他少數族裔長期以來所經歷的種族主義和不平等現象。

  • We are stepping up to bring people and organizations together to acknowledge the trauma of racial injustice, understand its many forms and create lasting change.

    我們正在加緊將人們和組織聚集在一起,以承認種族不公正的創傷,了解其多種形式並創造持久的變化。

  • To underscore our commitment to positive action, we also announced a pledge of $25 million and 25,000 employee volunteer hours over the next 5 years.

    為了強調我們對積極行動的承諾,我們還宣布承諾在未來 5 年內提供 2500 萬美元和 25,000 小時的員工志願服務時間。

  • The funding and volunteerism will be directed toward combating racial injustice and inequality primarily here in Indiana.

    資金和志願服務將主要用於在印第安納州打擊種族不公正和不平等。

  • And we plan to partner with other businesses and community groups to achieve our goals.

    我們計劃與其他企業和社區團體合作以實現我們的目標。

  • While there's nothing easy about the road ahead, we can no longer accept systemic bias in any of its forms.

    雖然前方的道路並不容易,但我們不能再接受任何形式的系統性偏見。

  • And the time for platitudes is now behind us.

    陳詞濫調的時代已經過去了。

  • The time for meaningful action, specifically by the corporate community, to drive lasting change is, in fact, now.

    事實上,現在是時候採取有意義的行動,特別是企業界,以推動持久的變革。

  • So a busy quarter.

    所以一個繁忙的季度。

  • Let me conclude with some closing comments on our progress in the first half of the year.

    最後,讓我總結一下我們在今年上半年取得的進展。

  • As expected, our business experienced headwinds this quarter based on reduced new patient starts and changes in inventory we highlighted earlier this year.

    正如預期的那樣,由於我們今年早些時候強調的新患者開始減少和庫存變化,本季度我們的業務遇到了不利因素。

  • With that in mind, we are pleased that in the first half of 2020, we delivered strong volume-driven revenue growth of 7% worldwide in constant currency.

    考慮到這一點,我們很高興在 2020 年上半年,我們在全球範圍內實現了以固定匯率計算的 7% 的強勁銷量增長。

  • We are cautiously optimistic about the recovery of both health care activity and prescription trends and expect both to accelerate during the second half of this year.

    我們對醫療保健活動和處方趨勢的複蘇持謹慎樂觀的態度,預計今年下半年兩者都將加速。

  • We continue to find innovative ways to ensure our patients have access to the medicines -- to their medicines and that we can support physicians and hospital systems as they provide care.

    我們繼續尋找創新的方法來確保我們的患者能夠獲得藥物——他們的藥物,並且我們可以在醫生和醫院系統提供護理時為他們提供支持。

  • Our operating margin improved 200 basis points over the first half of 2019, and we made exciting progress on our pipeline this quarter.

    與 2019 年上半年相比,我們的營業利潤率提高了 200 個基點,本季度我們的管道取得了令人振奮的進展。

  • We saw 3 top line Phase III data readouts from important clinical programs.

    我們看到了來自重要臨床項目的 3 個頂級 III 期數據讀數。

  • We had 5 U.S. approvals for NMEs and line extensions and achieved another -- a number of other clinical milestones that Dan just highlighted.

    我們在美國獲得了 5 項 NME 和產品線擴展的批准,並取得了另一個——Dan 剛剛強調的許多其他臨床里程碑。

  • The COVID-19 global pandemic continues to be a disruptive force in the way we all work and live.

    COVID-19 全球大流行繼續成為我們所有人工作和生活方式的破壞性力量。

  • Lilly and the broader pharmaceutical industry are working hard to develop new medicines to treat and to prevent the spread of COVID-19.

    禮來和更廣泛的製藥行業正在努力開發新藥來治療和預防 COVID-19 的傳播。

  • We anticipate this disruption will continue until vaccines and new medicines can be used to manage the spread of the infection.

    我們預計這種破壞將持續下去,直到可以使用疫苗和新藥來控制感染的傳播。

  • While near-term challenges do exist, we remain confident in the long-term outlook for our company and the strength of our fundamentals.

    儘管確實存在短期挑戰,但我們對公司的長期前景和基本面的實力仍然充滿信心。

  • Lilly and Lilly people will continue to rise to the challenge.

    禮來和禮來人將繼續迎接挑戰。

  • And I'm incredibly proud of our efforts to combat the global health crisis, social and economic crises we currently face.

    我為我們為應對當前面臨的全球健康危機、社會和經濟危機所做的努力感到無比自豪。

  • This concludes our prepared remarks.

    我們準備好的評論到此結束。

  • Now I'll turn the call over to Kevin, who will moderate the Q&A session.

    現在我將把電話轉給 Kevin,他將主持問答環節。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

  • (Operator Instructions) Kevin, if you can please provide the instructions for the Q&A session and then we're ready for the first caller.

    (操作員說明)Kevin,如果可以的話,請提供問答環節的說明,然後我們就可以接聽第一個來電者了。

  • Operator

    Operator

  • (Operator Instructions) We will now go to the first question.

    (操作員說明)我們現在將轉到第一個問題。

  • And that will be from Seamus Fernandez, Guggenheim.

    那將來自古根海姆的 Seamus Fernandez。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • So just a couple of quick questions, first, for Dan.

    首先,請給 Dan 提幾個簡單的問題。

  • Dan, can you help us understand a little bit more about the timing of your CoV-2 antibody data?

    丹,您能幫我們更多地了解一下您的 CoV-2 抗體數據的時間安排嗎?

  • And also, just wanted to get a little bit of the scientific discussion around your choice of pursuing a single antibody.

    而且,只是想圍繞您選擇單一抗體進行一些科學討論。

  • I know that the AbCellera technology is unique.

    我知道 AbCelera 技術是獨一無二的。

  • But just wanted to have a little bit more of a discussion around that.

    但只是想圍繞這一點進行更多討論。

  • I think that would be helpful for investors as we think about the choice of a single antibody.

    當我們考慮選擇單一抗體時,我認為這對投資者有幫助。

  • I know you've talked about manufacturing as a driving choice there.

    我知道你曾談到製造業是那裡的一種驅動選擇。

  • But obviously, the efficacy is paramount.

    但顯然,功效是最重要的。

  • So we just wanted to get a full understanding of that dynamic and that choice and how you hope the study is going to read out.

    因此,我們只是想全面了解這種動態和選擇,以及您希望這項研究如何宣讀。

  • And then secondly, just as we think about the margin dynamics in the second half of the year, Josh, I was just hoping that you could help us better understand the directional trajectory of how you're expecting the margins to shape up in the second half.

    其次,正如我們考慮下半年的利潤率動態一樣,喬希,我只是希望你能幫助我們更好地了解你期望利潤率在第二年如何形成的方向軌跡一半。

  • How much of that is driven by meaningful revenue acceleration versus just an ability to kind of manage the expense line?

    其中有多少是由有意義的收入加速推動的,而不僅僅是一種管理費用線的能力?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Seamus.

    謝謝,西莫。

  • Dan and then Josh.

    丹,然後是喬希。

  • 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

  • Great.

    偉大的。

  • Thanks, Seamus, for those questions about the COVID-19 antibodies.

    感謝 Seamus,關於 COVID-19 抗體的問題。

  • Maybe just starting with timing, of course, the timing of data disclosures depends on how fast the trials enroll and what the data show.

    當然,也許只是從時間開始,數據披露的時間取決於試驗註冊的速度和數據顯示的內容。

  • We're committed to getting important information out to the public and the scientific community as quickly as it's available.

    我們致力於盡快向公眾和科學界提供重要信息。

  • With respect to the Phase II trial that's focused on kind of viral load, I think this is going to be the first and probably a key indicator of potential efficacy for this approach.

    關於專注於病毒載量的 II 期試驗,我認為這將是第一個也可能是這種方法潛在功效的關鍵指標。

  • And I commented that we expect to have that data to disclose from this 400-patient Phase II trial in Q4.

    我評論說,我們希望在第四季度從這項 400 名患者的 II 期試驗中披露這些數據。

  • But again, that just depends on how fast we can enroll these patients.

    但同樣,這僅取決於我們能夠以多快的速度招募這些患者。

  • Your second question there was around the rationale for a single antibody versus 2 or 3 cocktails of even more antibodies that have been proposed.

    您的第二個問題是關於單一抗體與已提出的更多抗體的 2 或 3 種混合物的基本原理。

  • And specifically, you asked around efficacy.

    具體來說,您詢問了療效。

  • So I think we and others have looked at monotherapy versus combination therapy in a variety of preclinical models of the disease and looking at neutralization of the virus infection of human cells, for example.

    因此,我認為我們和其他人已經在各種疾病的臨床前模型中研究了單一療法與聯合療法,並研究了對人類細胞病毒感染的中和作用。

  • And what you find is that combinations don't offer an efficacy boost.

    你會發現這些組合併不能提高療效。

  • A single antibody can generally neutralize the virus just as well as combinations of antibody.

    單一抗體通常可以中和病毒,就像抗體的組合一樣。

  • The reason that people sometimes try combinations of antibody is because they're worried that over time, resistance could emerge.

    人們有時嘗試抗體組合的原因是因為他們擔心隨著時間的推移會出現耐藥性。

  • So I don't expect to see any efficacy boost or efficacy diminution from having a combo or monotherapy in clinical trials.

    因此,我不希望在臨床試驗中看到組合或單一療法的任何功效提升或功效降低。

  • What we'll be looking for instead is whether or not there's emergence of resistance.

    相反,我們要尋找的是是否出現了阻力。

  • There are some factors that make that somewhat less likely here.

    有一些因素使得這裡不太可能發生這種情況。

  • I think the extremely high potency of 555 and its ability to effectively neutralize virus very, very quickly may decrease the risk of resistance.

    我認為 555 的極高效力及其非常、非常迅速地有效中和病毒的能力可能會降低耐藥性的風險。

  • We've done some primate studies and we've not seen resistance emerge in those studies at all.

    我們已經進行了一些靈長類動物研究,但我們根本沒有看到這些研究中出現抗藥性。

  • But we'll be watching patients carefully.

    但我們會仔細觀察患者。

  • And we have the combination therapy that will move forward as a backup if resistance is seen.

    如果出現耐藥性,我們有聯合療法作為後備療法。

  • The advantages of monotherapy are obvious and you commented on them.

    單一療法的優勢是顯而易見的,您對此進行了評論。

  • It's simply that if you have one antibody, you can manufacture twice as much as a combo of 2 antibodies, 3 times as much as 3 antibodies.

    很簡單,如果你有一種抗體,你可以製造出 2 種抗體組合的兩倍,3 種抗體的 3 倍。

  • In a situation like this, I think there's societal tradeoffs that might indicate maximizing manufacturing capacity is a key objective.

    在這種情況下,我認為社會權衡可能表明最大化製造能力是一個關鍵目標。

  • And so that's where we're aimed here.

    這就是我們的目標。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • And Josh?

    喬什呢?

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Thanks, Seamus.

    謝謝,西莫。

  • Yes.

    是的。

  • So if we look at our guidance for the year and think about the margin progression in the second half of the year, just a reminder, sales on a constant currency basis grew 7% in the first half.

    因此,如果我們查看我們的年度指導並考慮下半年的利潤率增長,提醒一下,上半年的固定貨幣銷售額增長了 7%。

  • And our operating income percentage was a little bit over 29%.

    我們的營業收入百分比略高於 29%。

  • So to get to the 31% target we have for 2020, well, obviously, we've got to see margin expansion in the second half of the year.

    因此,要達到我們在 2020 年設定的 31% 的目標,顯然,我們必須在下半年看到利潤率增長。

  • But I think it's pretty straightforward.

    但我認為這很簡單。

  • When we look at the sales range that we have, picking midpoints or wherever you want to pick, we're looking really at something close to 7% or 8% growth in the second half of the year.

    當我們查看我們擁有的銷售範圍、選擇中點或您想要選擇的任何地方時,我們確實看到了下半年接近 7% 或 8% 的增長。

  • So while we expect an acceleration in sort of absolute sales on a half-to-half basis, it's not that much of a stretch from where we are.

    因此,雖然我們預計絕對銷售額會在一半到一半的基礎上加速增長,但與我們所處的位置相比並沒有太大的延伸。

  • We expect a little bit of a pickup probably in gross margin in basis points.

    我們預計毛利率可能會略有回升,以基點計算。

  • And that's just a function of more normalized geographic impacts.

    這只是更規範化的地理影響的一個功能。

  • As you know, we saw more of an impact in the U.S. in the first half of the year than outside the U.S. We expect those things to normalize a little bit in the second half of the year.

    如您所知,今年上半年我們在美國看到的影響比在美國以外的影響更大。我們預計這些情況在下半年會稍微正常化。

  • And we're not anticipating any onetime pricing impacts, either up or down.

    而且我們預計不會出現任何一次性定價影響,無論是上漲還是下跌。

  • So you'll see a little bit of a benefit there.

    所以你會在那裡看到一點好處。

  • But the big piece will come on the OpEx side and it's not from additional sort of cost savings moves.

    但重要的部分將出現在運營支出方面,而不是來自額外的成本節約舉措。

  • Our guidance range we provide for, again picking wherever you want to pick in the range, a couple hundred million dollars or so of increased investment in absolute dollars in combination of SG&A and R&D in the second half of the year.

    我們提供的指導範圍,再次選擇您想在該範圍內選擇的任何地方,在今年下半年結合 SG&A 和 R&D 的絕對美元增加了幾億美元左右的投資。

  • So it's really just the absolute sales benefit that we'll see in the second half against a lower absolute increase but still an increase in OpEx.

    所以這實際上只是我們將在下半年看到的絕對銷售收益,相對於較低的絕對增長但仍然是運營支出的增長。

  • That gets us to something over 31% in the second half of the year.

    這使我們在今年下半年達到了超過 31% 的水平。

  • And put that together, that puts us at 31%.

    把這些放在一起,我們就達到了 31%。

  • We feel like most of these things are certainly in our control.

    我們覺得這些事情中的大部分都在我們的控制之中。

  • As I mentioned earlier and as Dan has talked about on COVID, we're going to invest fully behind those opportunities.

    正如我之前提到的以及丹在 COVID 上談到的那樣,我們將全力投資於這些機會。

  • That is contemplated in our guidance range.

    這在我們的指導範圍內。

  • And to the extent we're higher on OpEx, at the higher end of the range, it's going to be primarily because of seeing good data and continue to move fast there.

    就我們的運營支出而言,在範圍的高端,這將主要是因為看到了良好的數據並繼續在那裡快速移動。

  • But we're confident in the margin expansion opportunity into the second half of the year for the reasons I just mentioned.

    但由於我剛才提到的原因,我們對下半年的利潤率擴張機會充滿信心。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • Seamus, thanks for your questions.

    Seamus,謝謝你的提問。

  • Operator

    Operator

  • And that will be from the line of Geoff Meacham, Bank of America.

    這將來自美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • Just had a few.

    剛吃了幾個。

  • On Verzenio, I know we have yet to see data details.

    在 Verzenio 上,我知道我們還沒有看到數據細節。

  • But can you speak to the real-world duration of therapy today in metastatic and then what you would expect from the monarchE setting?

    但是,您能否談談當今轉移性治療的真實世界持續時間以及您對 monarchE 環境的期望?

  • And then a quick drug pricing question for Dave.

    然後是戴夫的快速藥品定價問題。

  • I know obviously you spend a lot of time on these issues.

    我知道很明顯你在這些問題上花了很多時間。

  • But what are the hurdles to getting IPI implemented?

    但實施 IPI 的障礙是什麼?

  • And when you look across the Lilly portfolio, can you speak to categories that may be more impacted from the executive order, either IPI, rebates, et cetera?

    當您查看禮來公司的產品組合時,您能否談談可能受行政命令影響更大的類別,IPI、回扣等?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Geoff.

    謝謝,傑夫。

  • We'll go to Anne for the question on Verzenio and then Dave on IPI.

    我們將向 Anne 詢問有關 Verzenio 的問題,然後向 Dave 詢問有關 IPI 的問題。

  • Anne E. White - Senior VP & President of Lilly Oncology

    Anne E. White - Senior VP & President of Lilly Oncology

  • Well, Geoff, thanks for the question on Verzenio.

    好吧,傑夫,謝謝你關於 Verzenio 的問題。

  • And the duration question is an important one and something that we're really excited about as part of the additional opportunity in EBC.

    持續時間問題是一個重要的問題,作為 EBC 額外機會的一部分,我們非常興奮。

  • And so we do expect the duration of treatment to be longer than the metastatic setting.

    因此,我們確實預計治療的持續時間會比轉移性設置長。

  • And to your question, what we've seen in RWE in the metastatic setting is about 8 months.

    對於你的問題,我們在 RWE 中看到的轉移性環境大約是 8 個月。

  • Now we'll need to see what that actually is once patients are being treated upon approval in the adjuvant setting.

    現在,我們需要看看一旦患者在輔助環境中獲得批准後接受治療,這實際上是什麼情況。

  • But obviously, we're encouraged, the fact is the treatment duration in the study itself was 24 months.

    但顯然,我們感到鼓舞的是,研究本身的治療持續時間是 24 個月。

  • So we do expect it to be much longer than the 8 months that we see in the metastatic setting.

    因此,我們確實預計它會比我們在轉移性環境中看到的 8 個月長得多。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Anne.

    謝謝,安妮。

  • Dave?

    戴夫?

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Yes.

    是的。

  • Thanks, Geoff.

    謝謝,傑夫。

  • Well, I mean, we all observed last Friday's announcements.

    嗯,我的意思是,我們都觀察了上週五的公告。

  • I think mostly, these are not particularly new ideas.

    我認為大多數情況下,這些都不是特別新的想法。

  • So my statements may be a repeat from prior calls.

    所以我的陳述可能是之前電話的重複。

  • But on IPI specifically, this is being proposed under the CMMI model, Affordable Care Act.

    但特別是在 IPI 上,這是根據 CMMI 模型“平價醫療法案”提出的。

  • So that by itself is a probably a problem to seek to regulate the entirety of the U.S. physician-infused market via that mechanism.

    因此,通過該機制尋求規範整個美國醫生注入市場本身可能是一個問題。

  • And I think you expect the industry to vigorously challenge that authority.

    而且我認為您希望該行業大力挑戰該權威。

  • EOs don't create new authority.

    EO不會創造新的權威。

  • But if implemented, and we have yet to see the text, by the way.

    但如果實施了,我們還沒有看到文本,順便說一句。

  • I'm not sure the White House has put that out yet.

    我不確定白宮是否已經發布了這一消息。

  • But let's assume it's something like the 2018 blueprint proposal.

    但讓我們假設它類似於 2018 年的藍圖提案。

  • We are relatively underexposed to this idea because it affects Part B physician-infused drugs.

    我們對這個想法的了解相對不足,因為它會影響 B 部分醫生注入的藥物。

  • Today, the 2 material medicines fit that in our portfolio, Alimta and Cyramza.

    今天,這兩種材料藥物適合我們的產品組合,Alimta 和 Cyramza。

  • Of course, Alimta, we expect a patent expiry in spring of '22.

    當然,Alimta,我們預計專利將在 22 年春季到期。

  • So you have a time window impact that's quite short; and Cyramza, which is obviously longer and a meaningful product, but a part of our growth story but not a cornerstone of it.

    所以你有一個很短的時間窗口影響;和 Cyramza,它顯然是更長且有意義的產品,但它是我們成長故事的一部分,但不是它的基石。

  • Going forward, of course, if we looked at future medicines in the pipeline, there are infused medicines in immunology.

    當然,展望未來,如果我們著眼於未來正在研發的藥物,免疫學領域就會出現注入藥物。

  • And notably, in Alzheimer's, should those succeed, that would -- you'd be concerned about.

    值得注意的是,在阿爾茨海默氏症中,如果那些成功了,那將會 - 你會擔心。

  • But I think drug companies have more ability to navigate on future products than they do on past -- products launched in the past because you can affect your primarily European pricing outlook perhaps with constrained demand in Europe but focused on a common floor price for the U.S. So we can navigate it.

    但我認為與過去相比,製藥公司對未來產品的駕馭能力更強——過去推出的產品是因為您可能會影響您主要在歐洲的定價前景,也許是在歐洲需求受限的情況下,但專注於美國的共同底價。所以我們可以導航它。

  • That said, it's horrible policy.

    也就是說,這是一個可怕的政策。

  • And I think will -- sends a wrong message at a time when this industry is working literally day and night to help us all escape from COVID-19.

    我認為會 - 在這個行業日夜工作以幫助我們所有人擺脫 COVID-19 的時候發出錯誤的信息。

  • Do we really want to be talking about this disruptive force?

    我們真的想談論這種破壞性力量嗎?

  • And the most well-capitalized companies are the least affected.

    資本最雄厚的公司受影響最小。

  • Biotech, which we're not part of that small company group, but they will be severely affected.

    生物技術,我們不屬於那個小公司集團,但它們將受到嚴重影響。

  • And investor interest in many of their companies could drop precipitously.

    投資者對其許多公司的興趣可能會急劇下降。

  • I think that will be a real loss for what is an industry that's basically U.S.-based.

    我認為對於一個基本上以美國為基地的行業來說,這將是一個真正的損失。

  • So we will fight it hard.

    所以我們會努力奮鬥。

  • And hopefully, it won't come to be.

    希望它不會發生。

  • On rebate, again this is an idea we've pursued and have been for, for some time as well as frankly we're not disappointed by the 340B pass-through idea that was presented as well.

    關於回扣,這也是我們一直追求和堅持的一個想法,坦率地說,我們對也提出的 340B 直通想法並不感到失望。

  • We think that the patients who drive the volume the plans negotiate discounts on should benefit from those discounts frankly as they do in every other part of the health care system, except medicines.

    我們認為,推動計劃談判折扣的患者應該坦率地從這些折扣中受益,就像他們在醫療保健系統的其他所有部分一樣,除了藥品。

  • So that we think cost sharing and co-pay should be based on net price, not list and these ideas forward that.

    所以我們認為成本分攤和共同支付應該基於淨價,而不是清單,這些想法推動了這一點。

  • Again, lots of barriers to implementation on those as well.

    同樣,在這些方面也有很多實施障礙。

  • And I'm sure other groups will oppose them.

    我相信其他團體會反對他們。

  • But we'll continue to support that concept of sharing the savings.

    但我們將繼續支持分享節省的概念。

  • 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。

  • Operator

    Operator

  • Tim Anderson, Wolfe Research.

    蒂姆安德森,沃爾夫研究。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • I have a commercial question on CDK4/6 class.

    我有一個關於 CDK4/6 類的商業問題。

  • So Pfizer's Ibrance is the market leader.

    所以輝瑞的 Ibrance 是市場領導者。

  • But it is the only CDK4/6 that failed to show a survival benefit in formal [Phase II] trials in metastatic.

    但它是唯一在轉移性正式 [II 期] 試驗中未能顯示生存益處的 CDK4/6。

  • And of course, it failed in adjuvant.

    當然,它在佐劑方面失敗了。

  • Does Lilly think that the metastatic share that Ibrance has is materially at risk to competitors like Verzenio?

    Lilly 是否認為 Ibrance 的轉移份額對 Verzenio 等競爭對手存在重大風險?

  • Or will there realistically be stickiness to this segment?

    或者這個細分市場真的會有粘性嗎?

  • Pfizer said that its real-world study that show an OS benefit will protect it.

    輝瑞表示,其顯示操作系統優勢的實際研究將保護它。

  • But wondering what your view is.

    但想知道你的觀點是什麼。

  • So it's really a question on the metastatic segment.

    所以這確實是關於轉移部分的問題。

  • And then on tirzepatide, how do you characterize your level of confidence that the first upcoming Phase III results are going to be data that really wows investors like the Phase II trial results did?

    然後關於 tirzepatide,您如何描述您對即將到來的第一個 III 期結果將成為像 II 期試驗結果一樣真正讓投資者驚嘆的數據的信心水平?

  • It's notable that analysts already carry about a $5 billion estimate for tirzepatide in the consensus model.

    值得注意的是,分析師已經在共識模型中對 tirzepatide 進行了約 50 億美元的估計。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Tim.

    謝謝,蒂姆。

  • We'll go to Anne for the question on the CDK4/6 class and then Mike Mason for the question on tirzepatide.

    我們將向 Anne 詢問關於 CDK4/6 課程的問題,然後向 Mike Mason 詢問關於 tirzepatide 的問題。

  • Anne E. White - Senior VP & President of Lilly Oncology

    Anne E. White - Senior VP & President of Lilly Oncology

  • Well, thanks for the question, Tim, on Verzenio.

    好吧,謝謝提姆,關於 Verzenio 的問題。

  • And I -- we believe we've seen really positive trends with Verzenio in the metastatic setting.

    而且我 - 我們相信我們已經看到 Verzenio 在轉移性環境中的真正積極趨勢。

  • And I think Josh mentioned those in some of the intro.

    我認為喬什在一些介紹中提到了這些。

  • And we've really capitalized on the positive overall survival data from MONARCH 2 in the combination with fulvestrant.

    我們確實利用了 MONARCH 2 與氟維司群的積極總體生存數據。

  • And so what we've seen versus Q2 2019 is worldwide growth of 56% in revenue and U.S. growth of 35%.

    因此,與 2019 年第二季度相比,我們看到的是全球收入增長 56%,美國增長 35%。

  • And then if we look globally, we now had 49 approvals worldwide.

    然後,如果我們放眼全球,我們現在在全球範圍內獲得了 49 項批准。

  • And I think probably an important metric is the Japan NBRx share of market now at 58%.

    我認為一個重要的指標可能是日本 NBRx 的市場份額現在為 58%。

  • And so we've seen a very strong launch in Japan.

    因此,我們在日本看到了非常強勁的發布。

  • And so we believe, obviously, that with statistically significant survival data, that's really the gold standard in this class.

    因此,顯然,我們相信,具有統計顯著性的生存數據,這確實是本課程的黃金標準。

  • And so we believe that more and more physicians will be trying Verzenio and we've seen that in the continued increase in the NBRx.

    所以我們相信越來越多的醫生會嘗試 Verzenio,我們已經在 NBRx 的持續增長中看到了這一點。

  • And so we'll continue to share that message.

    因此,我們將繼續分享該信息。

  • We believe that this is the best-in-class agent.

    我們相信這是一流的代理。

  • And I think it just goes to that whole picture of the differentiation that we see with Verzenio over time.

    而且我認為它只是隨著時間的推移我們看到的 Verzenio 差異化的全貌。

  • And I just think that, that will shift physicians' minds.

    我只是認為,這將改變醫生的想法。

  • The positive results from monarchE, as Dan mentioned, really do differentiate it from both CDK4/6s.

    正如 Dan 提到的,monarchE 的積極結果確實將它與 CDK4/6 區分開來。

  • And then we've got statistically significant results, not just in the overall population but then in the hard-to-treat populations, those with visceral disease and primary endocrine resistance.

    然後我們得到了具有統計學意義的結果,不僅在總體人群中,而且在難以治療的人群中,即患有內臟疾病和原發性內分泌抵抗的人群中。

  • And again, you didn't see that with some of the other CDK4/6s.

    再一次,您在其他一些 CDK4/6 中沒有看到這一點。

  • So I think we're starting to feel pretty strongly.

    所以我認為我們開始感覺非常強烈。

  • And I think physicians are starting to agree with us that we have a differentiated agent here.

    而且我認為醫生開始同意我們的觀點,即我們在這裡有一個差異化的代理。

  • And so you'll continue to see us press in the metastatic setting because we have that survival data.

    因此,您將繼續看到我們在轉移性環境中施壓,因為我們擁有生存數據。

  • And now we get to make the move into the adjuvant study.

    現在我們開始進入輔助研究。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Anne.

    謝謝,安妮。

  • Mike?

    麥克風?

  • Michael B. Mason - Senior VP & President of Lilly Diabetes

    Michael B. Mason - Senior VP & President of Lilly Diabetes

  • Okay.

    好的。

  • For tirzepatide, we're glad to see that you were wowed by our type -- our Phase II data in -- for patients living with type 2 diabetes.

    對於 tirzepatide,我們很高興看到您對我們的 2 型糖尿病患者類型(我們的 II 期數據)感到驚嘆。

  • I think the best thing really to do is to go back and take a look at the Phase II clinical studies.

    我認為真正要做的最好的事情是回去看看 II 期臨床研究。

  • I mean we saw at the 15-milligram dose up to 2.4% A1c reduction and weight loss up to 12.7% versus placebo in just 6 months of study.

    我的意思是,在短短 6 個月的研究中,與安慰劑相比,我們看到 15 毫克劑量的 A1c 降低了 2.4%,體重減輕了 12.7%。

  • So we're excited to see how tirzepatide can perform in this patient population and longer studies in Phase III.

    因此,我們很高興看到 tirzepatide 如何在這一患者群體中發揮作用,並在 III 期進行更長時間的研究。

  • There's nothing to tell us that we won't see exciting data coming out of the Phase III.

    沒有什麼可以告訴我們,我們不會從第三階段看到令人興奮的數據。

  • We don't have any new information that suggests otherwise.

    我們沒有任何新的信息表明其他情況。

  • So we are incredibly confident about tirzepatide, not only in type 2 diabetes, but also we're excited to see its potential in NASH and obesity.

    因此,我們對 tirzepatide 非常有信心,不僅在 2 型糖尿病方面,而且我們很高興看到它在 NASH 和肥胖症方面的潛力。

  • So our enthusiasm remains very, very high.

    所以我們的熱情仍然非常非常高。

  • Thank you for the question.

    感謝你的提問。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Mike.

    謝謝,邁克。

  • Tim, thanks for your questions.

    蒂姆,謝謝你的提問。

  • Operator

    Operator

  • And that's Umer Raffat of Evercore.

    那就是 Evercore 的 Umer Raffat。

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

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • Dan, I'm just trying to reconcile the positive commentary around your COVID mAb heading to registrational trials versus perhaps lack of any data -- efficacy data visibility from Phase I. And if you could possibly speak to any trends you've seen already, that would be really helpful.

    丹,我只是想調和圍繞你的 COVID mAb 進行註冊試驗的積極評論與可能缺乏任何數據——第一階段的療效數據可見性。如果你能談談你已經看到的任何趨勢,那真的很有幫助。

  • And then on KRAS, if you could -- I might have missed it, but if you could just add some more color on whether you ran into a therapeutic index challenge before efficacy kicked in.

    然後在 KRAS 上,如果可以的話——我可能會錯過它,但如果你能在療效開始之前添加更多顏色來說明你是否遇到了治療指數挑戰。

  • And if you could speak to what's the highest dose you actually dosed patients with on your KRAS.

    如果你能說出你在 KRAS 上實際給患者服用的最高劑量是多少。

  • Because it seems like other KRAS inhibitors who didn't really have any efficacy until a very high dose and all just kicked in at a certain dose.

    因為似乎其他 KRAS 抑製劑直到非常高劑量才真正有任何功效,並且都只是在一定劑量下才起作用。

  • So it would be really helpful.

    所以這真的很有幫助。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Umer.

    謝謝,烏默爾。

  • Dan, you'll take both of those?

    丹,你會拿這兩個嗎?

  • 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。

  • Sure.

    當然。

  • Umer, thanks for both those questions.

    Umer,感謝這兩個問題。

  • So on the COVID mAb, you're sort of asking about the rationale going to registrational studies without having seen efficacy data.

    因此,在 COVID mAb 上,您在沒有看到療效數據的情況下詢問進行註冊研究的基本原理。

  • It's not something we usually do.

    這不是我們通常會做的事情。

  • You're right.

    你是對的。

  • Of course, here, it's, as I said, the gravity of the situation and the rapidity with which we desire to test these therapies that have driven us to that decision.

    當然,正如我所說,正是情況的嚴重性和我們希望測試這些療法的速度促使我們做出了這個決定。

  • You asked about sort of trends that might have encouraged us from the Phase I study.

    您詢問了可能在第一階段研究中鼓勵我們的趨勢。

  • And unfortunately, the answer is we don't have anything to talk about.

    不幸的是,答案是我們無話可說。

  • We had one Phase I study that was in healthy volunteers.

    我們在健康志願者中進行了一項 I 期研究。

  • So they didn't have COVID-19, nothing to see there.

    所以他們沒有 COVID-19,那裡沒有什麼可看的。

  • And the other was so small in the hospitalized patients, 6 patients per dose group.

    而另一個在住院患者中則如此之少,每個劑量組有 6 名患者。

  • And I think what we saw there is basically what you would expect across doses and placebo.

    我認為我們在那裡看到的基本上是你對劑量和安慰劑的期望。

  • All of the patients actually did really well and got better and left the hospital.

    事實上,所有的病人都做得很好,並且好轉並離開了醫院。

  • And that's not atypical for a Phase I study here that the population that physicians typically pull into those studies are some of the better patients who might be at the end of their disease course.

    對於這裡的 I 期研究來說,這並不是非典型的,醫生通常會參與這些研究的人群是一些可能處於病程末期的更好的患者。

  • I wouldn't expect antibodies in any case to have much effect in people whose viral load is already low and their immune system is already clearing the disease.

    在任何情況下,我都不認為抗體會對病毒載量已經很低且免疫系統已經清除疾病的人產生太大影響。

  • So that's where we are.

    這就是我們所在的位置。

  • I think the Phase II study, on the other hand, is patients who are early in the disease course.

    另一方面,我認為 II 期研究是處於病程早期的患者。

  • They're just within a few days of getting diagnosed.

    他們只是在被診斷出幾天之內。

  • My expectations they'll have high and, in many cases, increasing viral loads in the absence of therapy.

    我的期望是,在沒有治療的情況下,他們會有很高的病毒載量,並且在許多情況下會增加病毒載量。

  • And the goal here is to show that the therapy decreases the viral load.

    這裡的目標是表明該療法可以降低病毒載量。

  • So that's the important readout.

    所以這是重要的讀數。

  • But as I said, we'll have started the Phase IIIs by then.

    但正如我所說,屆時我們將開始第三階段。

  • On KRAS, this is an issue of off-target toxicity.

    在 KRAS 上,這是一個脫靶毒性問題。

  • So it's not related to the KRAS target itself is our view.

    因此,我們認為這與 KRAS 目標本身無關。

  • That does, therefore, kill the therapeutic index and not possible to proceed with that drug.

    因此,這確實會破壞治療指數,並且無法繼續使用該藥物。

  • I don't think we, at this moment, give details on the exact nature of the toxicity or the highest dose that we tested.

    我認為目前我們不會詳細說明毒性的確切性質或我們測試的最高劑量。

  • But we didn't feel we could proceed based on the doses at which we saw that tox.

    但我們不認為我們可以根據我們看到的毒藥劑量繼續進行。

  • And we're trying to resolve that.

    我們正在努力解決這個問題。

  • In the backup program, we have some preclinical models for the tox.

    在備份程序中,我們有一些毒物的臨床前模型。

  • We'll see if they bear out or not.

    我們會看看他們是否堅持。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • Umer, thanks for your questions.

    烏默爾,謝謝你的提問。

  • Operator

    Operator

  • Andrew Baum of Citi.

    花旗銀行的安德魯鮑姆。

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • A question on U.S. drug price reform.

    關於美國藥品價格改革的問題。

  • There are a number of live propositions.

    有許多實時命題。

  • Obviously, the executive order referencing rebate reform, which obviously Lilly has supported, but it requires a positive CBO score in order to move forward.

    顯然,涉及回扣改革的行政命令,顯然禮來支持,但它需要一個積極的 CBO 分數才能向前推進。

  • First question is do you think there's any possibility that could be achieved, given the history of the CBO score and the belief required of an overall reduction in pricing through market-based competitions to get there and the CBO to reflect that?

    第一個問題是,鑑於 CBO 分數的歷史以及通過基於市場的競爭全面降低定價以達到目標以及 CBO 反映這一點的信念,您認為有可能實現嗎?

  • So that's number one.

    所以這是第一名。

  • And number two, an alternate proposition has got bipartisan support in the Senate.

    第二,另一個提議在參議院得到了兩黨的支持。

  • But it's stopping from reaching the Senate floor by Mitch McConnell.

    但是米奇·麥康奈爾(Mitch McConnell)阻止了它進入參議院。

  • I know you have some concerns over that bill.

    我知道你對那個法案有些擔心。

  • But as a potential way forward to mitigate a more deleterious solution under either of the potential options going forward, can you see this progressing?

    但是,作為一種潛在的前進方式,可以在未來的任何一種潛在選擇下減輕更有害的解決方案,您能看到這種進展嗎?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Andrew.

    謝謝,安德魯。

  • We'll go to Dave for both of those.

    我們將去戴夫為這兩個。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Yes.

    是的。

  • Thanks, Andrew.

    謝謝,安德魯。

  • On the EOs, you're talking about rebate reform and the idea of pass-through.

    在 EOs 上,您正在談論回扣改革和傳遞的想法。

  • And the history here is, as you pointed out, the CBO score was extremely negative.

    正如你所指出的,這裡的歷史是,CBO 分數非常負。

  • In our math, largely driven by the one assumption you noted, which is that rebate value would essentially accrue back to manufacturers and thus raise premiums, it's a deeply flawed assumption.

    在我們的數學計算中,很大程度上是由你提到的一個假設驅動的,即回扣價值基本上會返還給製造商,從而提高保費,這是一個有嚴重缺陷的假設。

  • Of course, we'll compete.

    當然,我們會競爭。

  • But the whole idea would be to move the basis of competition from sort of discriminated prices that are private to list price or other means to deliver pricing directly to consumers, discounts that pass-through, for instance.

    但整個想法是將競爭的基礎從私有的歧視性價格轉移到標價或其他直接向消費者提供定價的方式,例如傳遞折扣。

  • So that, of course, requires industry actors to change their practices.

    因此,這當然需要行業參與者改變他們的做法。

  • And that's not something that can be coordinated or messaged very well due to antitrust laws.

    由於反托拉斯法,這不是可以很好地協調或傳達信息的事情。

  • So we're sort of in this catch-22 on committing to deliver on sharing the savings but not being able to do that publicly.

    因此,我們有點在這個第 22 條關於承諾分享節省但不能公開這樣做的規定中。

  • I think that's a problem.

    我認為這是一個問題。

  • And it's particularly a problem for legislation.

    對於立法來說,這尤其是一個問題。

  • Of course, the executive order method has other problems in terms of legal power.

    當然,行政命令方式在法律權力方面還有其他問題。

  • But if enacted under administrative rules, there isn't necessarily a requirement to square the budget.

    但是,如果根據行政規則制定,則不一定需要調整預算。

  • So savings can be assumed in other ways and there's a different authority doing the math.

    因此,可以通過其他方式假設儲蓄,並且有不同的權威進行數學計算。

  • That said, I think there are headwinds on this point, both within the executive branch as well as on the Hill.

    也就是說,我認為在這一點上存在逆風,無論是在行政部門內部還是在希爾內部。

  • Nonetheless, it's the right thing to do.

    儘管如此,這是正確的做法。

  • And I think we need to continue to push for ways that everyone would have confidence that the industry would compete in a way that would lower consumer out-of-pocket costs.

    而且我認為我們需要繼續推動每個人都相信該行業將以降低消費者自付費用的方式競爭的方式。

  • I can tell you, that's the goal when we advocate for this policy.

    我可以告訴你,這就是我們倡導這項政策的目標。

  • And we need to find ways to provide that assurance, I think, to get movement.

    我認為,我們需要找到提供這種保證的方法,以獲得行動。

  • You talked about Senate Finance, and Grassley reintroduced a version of his bill to try to make one last push.

    你談到了參議院財政,格拉斯利重新提出了他的法案的一個版本,試圖做出最後的推動。

  • I believe his chairmanship is ending, in any case, at the end of this Congress.

    無論如何,我相信他的主席職位將在本屆大會結束時結束。

  • So it's understandable why he's doing that.

    所以他為什麼這樣做是可以理解的。

  • I don't think that, that package has much of a chance to advance.

    我不認為,那個包有很大的進步機會。

  • There are always way stars get aligned, and there's a number of health extenders do at the end of this Congress.

    總有辦法讓明星們保持一致,在本次大會結束時,有許多健康擴展者會這樣做。

  • But it's a pretty big piece of legislation to throw on an extenders package.

    但是,添加擴展包是一項相當大的立法。

  • The only possible way is that it does produce a positive budget impact, so in terms of you used to pay for other things.

    唯一可能的方法是它確實會產生積極的預算影響,因此就您過去支付其他事情而言。

  • But probably, you don't need the whole package.

    但可能你不需要整個包。

  • So I think that's still a narrow path.

    所以我認為這仍然是一條狹窄的道路。

  • And the most likely scenario is that these EOs can't take force and don't take force prior to a new presidential term, a new Congress sitting and that Senate Finance doesn't go anywhere either nor does HR 3. I think that's sort of the probable planning scenario.

    最有可能的情況是,這些 EO 不能生效,也不會在新總統任期、新國會開會之前生效,參議院財政也不會去任何地方,HR 3 也不會。我認為這是排序可能的規劃方案。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

  • Andrew, thanks for your questions.

    安德魯,謝謝你的提問。

  • Operator

    Operator

  • And that will be from the line of Louise Chen of Cantor.

    那將來自康托爾的路易絲·陳(Louise Chen)的路線。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So my first question is, is there any way to quantify the operating margins, what we would have seen in the first half '20 without R&D COVID spending and also headwind sales from the pandemic?

    所以我的第一個問題是,有沒有辦法量化營業利潤率,如果沒有研發 COVID 支出以及大流行帶來的逆風銷售,我們會在 20 年上半年看到什麼?

  • And the second question I had was do you -- how do you think about tirzepatide as a single solution for diabetes, NASH and obesity?

    我的第二個問題是,您如何看待 tirzepatide 作為糖尿病、NASH 和肥胖症的單一解決方案?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Louise.

    謝謝,路易絲。

  • We'll go to Josh for the first question and then Mike for the second one.

    第一個問題我們先找 Josh,然後第二個問題找 Mike。

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Thanks, Louise.

    謝謝,路易絲。

  • Yes, I think in the first half, as I mentioned, our operating margin was 29.1%.

    是的,我認為上半年,正如我所提到的,我們的營業利潤率為 29.1%。

  • I think if you add back some of the loss prescriptions, but then also keep in mind, we had some savings associated with promotion.

    我想如果你加回一些損失處方,但也要記住,我們有一些與促銷相關的儲蓄。

  • We're probably closer to 30%.

    我們可能接近 30%。

  • We said as we came into the year, we expected margin expansion through the year.

    我們說,當我們進入這一年時,我們預計全年利潤率會有所增長。

  • So that's still in track -- on track.

    所以這仍然在軌道上——在軌道上。

  • But we're probably off by somewhere in the range of the 50 to 100 basis points or something there.

    但我們可能偏離了 50 到 100 個基點或某個範圍內的某個地方。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • Mike?

    麥克風?

  • Michael B. Mason - Senior VP & President of Lilly Diabetes

    Michael B. Mason - Senior VP & President of Lilly Diabetes

  • No.

    不。

  • It's a great question on tirzepatide.

    這是關於 tirzepatide 的一個很好的問題。

  • And I think we have just a phenomenal opportunity to not just be able to provide glucose control for those living with type 2 diabetes but really affect their overall metabolic health.

    而且我認為我們有一個非凡的機會,不僅可以為 2 型糖尿病患者提供血糖控制,還可以真正影響他們的整體代謝健康。

  • And so I think the contributions of both GLP and GIP can provide the opportunity to really provide improved metabolic health across type 2 diabetes, obesity and NASH that are related.

    因此,我認為 GLP 和 GIP 的貢獻可以提供機會,真正改善相關的 2 型糖尿病、肥胖和 NASH 的代謝健康。

  • And so it's a great question.

    所以這是一個很好的問題。

  • I think it's a good opportunity for us to expand our focus beyond just helping someone living with type 2 diabetes a better control of glucose.

    我認為這對我們來說是一個很好的機會,可以擴大我們的關注點,而不僅僅是幫助 2 型糖尿病患者更好地控制血糖。

  • So great question, and obviously, it's an area that we will focus on.

    這麼好的問題,顯然,這是我們將關注的一個領域。

  • There will be people living with type 2 diabetes that are in our NASH and obesity studies.

    在我們的 NASH 和肥胖研究中,會有 2 型糖尿病患者。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Maybe just to add to that.

    也許只是為了補充。

  • It goes maybe without saying, but I'll say it.

    也許不用說,但我會說。

  • The current utilization of GLPs in the total diabetes population in developed markets is something like 1 in 8 or 1 in 10 patients.

    目前,發達市場糖尿病總人群中 GLP 的使用率約為 8 分之一或 10 名患者中的 1 例。

  • And so the hope here is that we can rearrange the priorities and the sequence of treatment in a way where this powerful category, and here, a dual-acting GIP/GLP could be used earlier and more broadly to manage disease outcomes in a very different way.

    因此,這裡的希望是,我們可以重新安排治療的重點和順序,使這一強大的類別,在這裡,雙重作用的 GIP/GLP 可以更早、更廣泛地用於管理疾病結果。方法。

  • Today, type 2 diabetes is disease of failure.

    今天,2 型糖尿病是一種失敗的疾病。

  • And perhaps this technology could help doctors and patients find success much earlier in the disease course.

    也許這項技術可以幫助醫生和患者在疾病過程中更早地取得成功。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Mike and Dave.

    謝謝,邁克和戴夫。

  • Louise, thanks for your questions.

    路易絲,謝謝你的提問。

  • Operator

    Operator

  • Terence Flynn, Goldman Sachs.

    特倫斯弗林,高盛。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • Was wondering on another one on Verzenio, if the monarchE data is going to be at ESMO or San Antonio Breast and then if you think penetration in the adjuvant setting will be higher, lower or the same as in the metastatic setting over time.

    想知道 Verzenio 上的另一個問題,如果 monarchE 數據將出現在 ESMO 或聖安東尼奧乳房,然後您是否認為隨著時間的推移,輔助環境中的滲透率會更高、更低或相同。

  • And then Josh, just on contracting, you talked about how those discussions are wrapping up now.

    然後喬希,就在簽約時,你談到了這些討論現在是如何結束的。

  • Anything notable in terms of Trulicity or Taltz that we should consider as we think about those contracts for 2021?

    在考慮 2021 年的這些合同時,我們應該考慮在 Trulicity 或 Taltz 方面有什麼值得注意的地方嗎?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Terence.

    謝謝,特倫斯。

  • We'll go to Anne for the question on monarchE and then Josh around the contracting.

    我們將向 Anne 詢問有關 monarchE 的問題,然後向 Josh 詢問有關合同的問題。

  • Anne E. White - Senior VP & President of Lilly Oncology

    Anne E. White - Senior VP & President of Lilly Oncology

  • Yes.

    是的。

  • So thanks for the question, Terence.

    所以謝謝你的問題,特倫斯。

  • So on the presentation, we will be presenting at a medical meeting later this year.

    因此,在演示文稿中,我們將在今年晚些時候的醫學會議上進行演示。

  • Unfortunately, I can't confirm which one yet.

    不幸的是,我還不能確定是哪一個。

  • But we will be presenting at a meeting this year.

    但我們將在今年的一次會議上發表演講。

  • As far as on the penetration, well, that's -- I think what's exciting about this opportunity is that we are the only CDK4/6 to have positive results in the adjuvant setting.

    至於滲透率,嗯,我認為這個機會令人興奮的是,我們是唯一在輔助環境中取得積極成果的 CDK4/6。

  • And so I think our penetration for the high-risk patients, which is the population that we had in monarchE, will be extremely high.

    所以我認為我們對高危患者的滲透率將非常高,也就是我們在 monarchE 中的人群。

  • So this -- as we're hearing people react even to the top line opportunity, we're seeing that there's a lot of enthusiasm for having CDK4/6 in the setting.

    所以這一點——當我們聽到人們甚至對頂線機會做出反應時,我們看到人們對在環境中使用 CDK4/6 充滿熱情。

  • And so we look forward to sharing those results, as I said, later this year.

    因此,正如我所說,我們期待在今年晚些時候分享這些結果。

  • Again, we see -- as I think Dan and others mentioned in the introduction, we see this as an opportunity, probably about 20,000 patients here in the U.S. as we matched our criteria in the study to the SEER database.

    我們再次看到——正如我認為 Dan 和其他人在介紹中提到的那樣,我們認為這是一個機會,在美國可能有大約 20,000 名患者,因為我們將研究中的標準與 SEER 數據庫相匹配。

  • So I think we see a pretty significant opportunity.

    所以我認為我們看到了一個非常重要的機會。

  • It's really probably half again of what we have in the metastatic setting, which has been significant.

    這真的可能是我們在轉移性環境中的一半,這很重要。

  • So we do -- to answer your question, we do expect strong penetration in this space over time.

    所以我們這樣做 - 為了回答你的問題,我們確實希望隨著時間的推移在這個領域有很強的滲透力。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Anne.

    謝謝,安妮。

  • Josh?

    喬什?

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Yes.

    是的。

  • As you know, Terence, we won't sort of talk specifically about individual contracts or anything at this point.

    如你所知,Terence,我們現在不會專門談論個人合同或任何事情。

  • But I think for what we have seen, first, I'd go back to the earlier comments that we see a pretty similar pricing environment in 2021 to what we're seeing here, which would be modest net price declines, meaning we're providing slightly more rebates than what we're anticipating in terms of list price increases.

    但我認為,就我們所看到的而言,首先,我會回到之前的評論,即我們在 2021 年看到的定價環境與我們在這裡看到的非常相似,這將是適度的淨價格下跌,這意味著我們正在提供比我們預期的價格上漲略多的回扣。

  • And then we couple that with the other dynamic factors that we've mentioned.

    然後我們將其與我們提到的其他動態因素結合起來。

  • I think -- if you think about Trulicity, we've said sort of expect something plus or minus 5% net price declines over time.

    我認為 - 如果您考慮 Trulicity,我們已經說過隨著時間的推移,預計淨價格會出現正負 5% 的下降。

  • I think that's how we're viewing next year, it's a very competitive environment, of course.

    我認為這就是我們明年的看法,當然,這是一個競爭非常激烈的環境。

  • But we're focused on maintaining access, not looking to trade price per share or anything like that.

    但我們專注於維護訪問權限,而不是尋求每股交易價格或類似的東西。

  • So I think those negotiations are going as expected.

    所以我認為這些談判正在按預期進行。

  • With Taltz, we've been focused on upgrading our access.

    通過 Taltz,我們一直專注於升級我們的訪問權限。

  • And so to the extent that we're able to do that, you'll see that in as a net price decline potentially but compensated for by increased access.

    因此,在我們能夠做到這一點的範圍內,您會看到這可能會導致淨價格下降,但可以通過增加訪問量來彌補。

  • Again, I think we're happy with the progress we're making this year and continue to focus on improving where we can for next year.

    同樣,我認為我們對今年取得的進展感到滿意,並繼續專注於明年的改進。

  • But overall, again I'd say the general trend is we have fierce competition in the classes we're in, but we're focused on maintaining at least the access we have today and when we have the chance upgrading in areas like immunology.

    但總的來說,我要再次說總體趨勢是我們在我們所在的課程中競爭激烈,但我們專注於至少保持我們今天擁有的訪問權限以及當我們有機會在免疫學等領域升級時。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • Terence, thanks for your questions.

    特倫斯,謝謝你的提問。

  • Operator

    Operator

  • Next will be Chris Schott, JPMorgan.

    接下來是摩根大通的克里斯肖特。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just maybe first on Verzenio, you highlighted 20,000 patients potentially in the U.S. Maybe just give us similar metrics about how you're thinking about the size of the eligible population in developed ex U.S. markets.

    也許首先在 Verzenio 上,您強調了可能在美國的 20,000 名患者。也許只是給我們類似的指標,說明您如何考慮美國以外發達市場的合格人口規模。

  • And then a second question, very helpful color in terms of kind of the mix in unemployment headwinds for 2021.

    然後是第二個問題,就 2021 年失業逆風的混合情況而言,這是非常有用的顏色。

  • Any updates in terms of how you're thinking about potential international price pressures from some of the budget deficits we're seeing globally?

    關於您如何看待我們在全球範圍內看到的一些預算赤字帶來的潛在國際價格壓力的任何更新?

  • Is that a '21 headwind to think about as well?

    這也是21年的逆風嗎?

  • Or is that going to take a bit longer to manifest itself?

    還是需要更長的時間才能顯現出來?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Chris.

    謝謝,克里斯。

  • We'll go to Anne for Verzenio and then to Dave on the international question.

    我們將去找安妮討論 Verzenio,然後就國際問題找戴夫。

  • Anne E. White - Senior VP & President of Lilly Oncology

    Anne E. White - Senior VP & President of Lilly Oncology

  • Great.

    偉大的。

  • So thanks so much for that question on the Verzenio-eligible population.

    因此,非常感謝關於 Verzenio 合格人群的問題。

  • And so as I said in the U.S., about 20,000 eligible patients, which is about 10% to 15% of the HR-positive, HER2-negative EBC population.

    正如我所說,在美國,大約有 20,000 名符合條件的患者,約佔 HR 陽性、HER2 陰性 EBC 人群的 10% 到 15%。

  • Outside the U.S., the pathology is similar, we estimate.

    我們估計,在美國以外,病理學是相似的。

  • And so we estimate patient numbers in Europe about 10% larger than the U.S. And then Japan is about 1/4 of the size the U.S. So I hope that answers the estimate questions outside the U.S.

    因此,我們估計歐洲的患者人數比美國多 10%。然後日本的規模約為美國的 1/4。所以我希望這能回答美國以外的估計問題。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Great.

    偉大的。

  • And on international pricing, I think we've talked about this before.

    關於國際定價,我想我們之前已經討論過這個問題。

  • But we don't have that many proxies for this kind of situation.

    但是對於這種情況,我們沒有那麼多代理。

  • But what we do know is economic activity, particularly in Europe and Japan, has fallen like in the U.S. tax receipts accordingly.

    但我們所知道的是,經濟活動,特別是在歐洲和日本,已經像美國的稅收收入一樣相應下降。

  • And if we use 2008 as a proxy, really took almost 3 years for the policy implications of that to show up in drug pricing health budgets.

    如果我們以 2008 年為代表,實際上需要將近 3 年的時間才能將其政策影響體現在藥品定價衛生預算中。

  • And that's natural because there's a lag in tax receipts and then there's a lag in policymaking in response to it.

    這是很自然的,因為稅收收入有滯後,然後政策制定也有滯後。

  • I would expect that to happen.

    我希望這會發生。

  • And the normal things that occur are clawback mechanisms and methods to keep the medicines budget within some proportion of the health budget.

    發生的正常事情是回撥機制和方法,以將藥物預算保持在衛生預算的一定比例內。

  • I think that will be a headwind the industry will face over the next 2 or 3 years.

    我認為這將是該行業在未來 2 或 3 年內將面臨的逆風。

  • I would say though that if history follows, and I don't see any reason why it wouldn't because Europeans in particular were successful at capping drug spending growth in the early part of the last decade, the burden of that tends to follow -- fall disproportionately on older products that are scaled and perhaps with more competition in the categories, whereas newer products, I think, actually weren't really affected.

    我想說的是,如果歷史隨之而來,我看不出有什麼理由不會因為歐洲人在過去十年的早期特別成功地限制了藥物支出的增長,那麼這種負擔往往會隨之而來—— - 不成比例地落在規模較大的舊產品上,並且可能在類別中有更多競爭,而我認為新產品實際上並沒有受到真正的影響。

  • They're more driven by health technology assessment and the procedures to get an initial price.

    他們更多地受到健康技術評估和獲得初始價格的程序的驅動。

  • And they don't really drive much budget pressure versus end of life.

    而且他們並沒有真正推動太大的預算壓力而不是生命的結束。

  • As you know, we continually advocate for more biosimilar and generic adoption in these markets as the first lever to pull.

    如您所知,我們不斷倡導在這些市場中採用更多的生物仿製藥和仿製藥,作為拉動的第一個槓桿。

  • And so I think also for products that are exposed to biosimilars and generics, you probably would see more pressure on the back end of this as well.

    因此,我認為對於那些暴露於生物仿製藥和仿製藥的產品,你可能也會在後端看到更大的壓力。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

  • Chris, thanks for your questions.

    克里斯,謝謝你的提問。

  • Operator

    Operator

  • The next question is from Vamil Divan from Mizuho.

    下一個問題來自瑞穗的 Vamil Divan。

  • Vamil Kishore Divan - MD

    Vamil Kishore Divan - MD

  • So a couple, if I can.

    如果可以的話,一對夫婦。

  • So one, on -- just on the margin discussion, specifically on SG&A, wondering if you have any comments you can share just in terms of your sort of more virtual promotional efforts here the past few months and a sense of how productive they've been.

    所以一個,就在邊際討論中,特別是關於 SG&A,想知道你是否有任何意見可以分享,就你過去幾個月在這裡進行的更多虛擬促銷活動以及他們的生產力有多大的感覺到過。

  • And really just trying to get a sense, as you think about going forward, is your spending on SG&A potentially going to be less than what you're thinking before if you go to more of a hybrid sort of model?

    當您考慮前進時,實際上只是想了解一下,如果您採用更多混合模式,您在 SG&A 上的支出是否可能會少於您之前的想法?

  • Or do you expect within kind of year or so, your SG&A spending would be essentially what it would have been before the pandemic?

    或者您是否期望在一年左右的時間內,您的 SG&A 支出基本上會與大流行之前的水平相同?

  • And then the second one is just maybe more on the business development side, just given some of the volatility you're seeing from the terms on COVID and also drug pricing.

    然後第二個可能更多的是在業務發展方面,只是考慮到您從 COVID 條款和藥品定價中看到的一些波動性。

  • And just any changes to how you're thinking about potential licensing or acquisitions in terms of size?

    就規模而言,您對潛在許可或收購的看法是否有任何變化?

  • Or also curious in terms of therapeutic areas, are there any sort of areas where you could have more need or desire or take capacity to bring in additional assets?

    或者也對治療領域感到好奇,是否有任何領域你可能有更多的需求或願望或有能力引進額外的資產?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Vamil.

    謝謝,瓦米爾。

  • We'll go to Dave for your first question and then Josh for the second one on BD.

    我們將向 Dave 提出您的第一個問題,然後向 Josh 提出關於 BD 的第二個問題。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Yes.

    是的。

  • Vamil, for some years now, we've been on a journey to build out the capabilities to reach customers where they want to be reached and have relevant information at that time as well as around launches and key data readouts to be able to expand our capacity beyond just the sales channel to reach customers.

    Vamil,幾年來,我們一直在努力建立能夠接觸到他們想要接觸的客戶的能力,並在當時擁有相關信息,以及圍繞發布和關鍵數據讀出,以便能夠擴展我們的超越銷售渠道接觸客戶的能力。

  • That has proven pretty useful during this pandemic.

    在這次大流行期間,這已被證明非常有用。

  • And I would say, overall, the conditions, which, as I mentioned in my prepared remarks, are variable around the world in terms of being able to safely send reps into the field and actually even be able to be let into medical buildings and facilities.

    我想說,總的來說,正如我在準備好的評論中提到的那樣,世界各地的條件在能夠安全地派代表進入現場,甚至能夠進入醫療大樓和設施方面都是可變的.

  • I think there's a constraint there.

    我認為那裡有一個約束。

  • So we've leaned into this.

    所以我們已經傾向於這個。

  • We've accelerated some of the plans we had to increase volume and the richness of this capability.

    我們已經加快了一些我們必須增加數量和豐富此功能的計劃。

  • Overall, I think the results are -- and I think we prefer to run the hybrid model everywhere where we have sales reps and these capabilities.

    總的來說,我認為結果是 - 我認為我們更喜歡在我們擁有銷售代表和這些能力的任何地方運行混合模型。

  • Where we can't send sales reps, these capabilities have been useful.

    在我們無法派出銷售代表的地方,這些功能非常有用。

  • Is it as productive?

    它有生產力嗎?

  • I think it's certainly more efficient and it's more scalable.

    我認為它肯定更有效,並且更具可擴展性。

  • Whether it's as impactful, I think we'll need to watch through time.

    無論它是否具有影響力,我認為我們需要通過時間觀察。

  • We have different markets we serve.

    我們服務於不同的市場。

  • And I can say that in specialty markets, where you've got a smaller number of physicians and you can target your efforts extremely well, we mentioned Retevmo launch on this call, which is kind of a first thing for us was an approval and launch during the pandemic, I think we're pretty pleased with the progress there.

    我可以說,在專業市場,醫生人數較少,而且您可以非常有針對性地開展工作,我們在這次電話會議上提到了 Retevmo 的推出,這對我們來說首先是批准和推出在大流行期間,我認為我們對那裡的進展感到非常滿意。

  • On the other hand, primary care brands, it's a little more challenging because the way these practices are run and the variability and physicians' accessibility.

    另一方面,初級保健品牌更具挑戰性,因為這些實踐的運行方式以及可變性和醫生的可及性。

  • So I think the whole industry is probably learning this.

    所以我認為整個行業可能都在學習這一點。

  • But on the other side of this, we'll have a much more enhanced capability.

    但另一方面,我們將擁有更強大的能力。

  • And you can bet we're spending huge amounts of time on a global basis lifting that up now in a way that's pretty rigorous.

    你可以打賭,我們現在在全球範圍內花費大量時間以一種非常嚴格的方式提升它。

  • So more to come there, productivity to be seen; efficiency, yes; effectiveness, we probably see a lot of variability right now.

    所以更多的東西來了,生產力有待觀察;效率,是的;有效性,我們現在可能會看到很多變化。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

  • Josh?

    喬什?

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Yes.

    是的。

  • So on business development, our strategy hasn't changed.

    所以在業務發展上,我們的戰略沒有改變。

  • We continue to focus on acquiring a potential first-in-class or best-in-class projects or products in our therapeutic areas.

    我們繼續專注於在我們的治療領域收購潛在的一流或一流的項目或產品。

  • There's a high bar there.

    那裡有一個很高的酒吧。

  • We've had great progress in our internal pipeline.

    我們在內部管道方面取得了很大進展。

  • But we remain committed to finding those kind of opportunities.

    但我們仍然致力於尋找此類機會。

  • We have -- we're generating very strong cash flow.

    我們有 - 我們正在產生非常強勁的現金流。

  • We've got good investment-grade ratings and good liquidity, good access to capital markets.

    我們擁有良好的投資級評級和良好的流動性,以及良好的資本市場准入。

  • So even with all the disruptions related to COVID, I don't see any change for us.

    因此,即使有與 COVID 相關的所有乾擾,我也看不到我們有任何變化。

  • And then our ability to interact with smaller companies or access potential projects hasn't changed.

    然後我們與小公司互動或訪問潛在項目的能力沒有改變。

  • That's not impacted by COVID.

    這不受 COVID 的影響。

  • So it's really just a function of finding the right opportunities and ensuring that we can structure the deals in ways that create value for both sides.

    因此,這實際上只是尋找合適機會並確保我們能夠以為雙方創造價值的方式構建交易的功能。

  • And we'll continue to focus on that.

    我們將繼續關注這一點。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • Vamil, thanks for your questions.

    瓦米爾,謝謝你的提問。

  • Operator

    Operator

  • Next is Carter Gould, Barclays.

    接下來是 Barclays 的 Carter Gould。

  • Carter Lewis Gould - Senior Analyst

    Carter Lewis Gould - Senior Analyst

  • I guess two for Dan.

    我猜丹有兩個。

  • First, on the baricitinib studies in COVID, can you maybe just sort of frame sort of how you're thinking about these studies, your level of confidence in light of some of the other agents repurposed from RA that have failed, albeit upstream of JAK inhibition?

    首先,關於 COVID 中的 baricitinib 研究,您能否大概說明一下您對這些研究的看法,鑑於其他一些從 RA 重新利用的藥物已經失敗,儘管在 JAK 的上游,您的信心水平抑制?

  • And then as far as on the N3pG antibody side, are sort of time lines still intact?

    然後就 N3pG 抗體方面而言,時間線是否仍然完好無損?

  • Should we still expect that data to read out early next year?

    我們是否還應該期望這些數據會在明年初公佈?

  • And any commentary on how you're thinking about the hurdle to move into the pivotal studies?

    以及關於您如何考慮進入關鍵研究的障礙的任何評論?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Carter.

    謝謝,卡特。

  • 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

  • Yes.

    是的。

  • Sure.

    當然。

  • Thanks.

    謝謝。

  • On baricitinib, of course, we're encouraged.

    當然,我們鼓勵使用巴瑞替尼。

  • And the reason we did this trial is based on preclinical data around the mechanism of action of baricitinib.

    我們進行這項試驗的原因是基於圍繞巴瑞替尼作用機制的臨床前數據。

  • And I think the clinical effects of immune modulation in hospitalized patients with COVID-19 has been mixed.

    而且我認為免疫調節對 COVID-19 住院患者的臨床效果好壞參半。

  • As you pointed out, there have been some failures.

    正如你所指出的,有一些失敗。

  • There've also been some promising efficacy signals and even success, of course, with dexamethasone.

    當然,地塞米松也有一些有希望的療效信號,甚至成功。

  • So I think we just have to wait and see how this works.

    所以我認為我們只需要等待,看看它是如何工作的。

  • Treating patients in the hospitalized setting is important.

    在住院環境中治療患者很重要。

  • If we can reduce length of stay or decrease mortality, that will be an exciting result and maybe a stopgap measure until we have medicines that actually can fight off the virus, like I hope the neutralizing antibodies will.

    如果我們可以減少住院時間或降低死亡率,那將是一個令人興奮的結果,並且可能是一種權宜之計,直到我們擁有真正可以抵抗病毒的藥物,就像我希望中和抗體一樣。

  • As for N3pG, yes, we're still on the same time line as we've always been.

    至於 N3pG,是的,我們仍然像往常一樣處於同一時間線上。

  • The trial will wrap up at the very end of this year, which means we'll have data internally and likely some kind of top line just in the very start of next year.

    該試驗將在今年年底結束,這意味著我們將在內部獲得數據,並且可能在明年年初獲得某種頂線。

  • I think given the size of the study, we have a reasonably high hurdle rate.

    我認為考慮到研究的規模,我們有相當高的障礙率。

  • We are hoping to see a large effect size.

    我們希望看到更大的效果。

  • We base that belief on the level of plaque clearance we can get.

    我們將這種信念建立在我們可以獲得的斑塊清除水平上。

  • We get deeper and faster plaque clearance than has been shown with any other agents.

    與任何其他藥物相比,我們可以更深入、更快地清除斑塊。

  • So if clearing plaques is important to stopping disease progression, we should have a strong effect.

    因此,如果清除斑塊對於阻止疾病進展很重要,我們應該有很強的效果。

  • It's noteworthy that we also designed this trial to select a very careful patient population based on their tau levels at baseline.

    值得注意的是,我們還設計了這項試驗,以根據基線時的 tau 水平選擇非常謹慎的患者群體。

  • So we also expect a smaller standard deviation because the population should have a more uniform progression.

    所以我們也期望一個更小的標準偏差,因為總體應該有一個更一致的進展。

  • I also note that we started a second trial with N3pG already.

    我還注意到我們已經開始使用 N3pG 進行第二次試驗。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • Carter, thanks for your questions.

    卡特,謝謝你的提問。

  • Operator

    Operator

  • Next, Steve Scala of Cowen.

    接下來是 Cowen 的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • When we see the data from monarchE, can you reassure us that the disease-free survival improvement won't be an underwhelming 1% to 2%?

    當我們看到來自 monarchE 的數據時,您能否向我們保證,無病生存率的提高不會是 1% 到 2% 的令人印象深刻的水平?

  • Lilly seems excited about the data, so I would assume it's going to be stronger than 1% to 2%, maybe 3%, 4%, 5%.

    Lilly 似乎對這些數據感到興奮,所以我認為它會比 1% 到 2%,也許是 3%、4%、5% 更強。

  • And then secondly, Roche announced last week that it will have data from a large Phase II trial of a tau antibody very soon.

    其次,羅氏上周宣布,它將很快獲得來自 tau 抗體的大型 II 期試驗的數據。

  • Should the Roche study fail, can you highlight any differences between the Lilly and Roche molecules and/or the study design that could sustain optimism for the Lilly program?

    如果羅氏研究失敗,您能否強調禮來和羅氏分子之間的任何差異和/或可以維持禮來計劃樂觀的研究設計?

  • Or if the Roche molecule fails, should we assume that the Lilly molecule likely will follow a similar fate?

    或者如果羅氏分子失敗了,我們是否應該假設禮來分子可能會遵循類似的命運?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Steve.

    謝謝,史蒂夫。

  • We'll go to Anne for the question on monarchE and then Dan for the question on tau.

    我們將向 Anne 詢問有關 monarchE 的問題,然後向 Dan 詢問有關 tau 的問題。

  • Anne E. White - Senior VP & President of Lilly Oncology

    Anne E. White - Senior VP & President of Lilly Oncology

  • Well, Steve, thanks for the question.

    好吧,史蒂夫,謝謝你的問題。

  • Obviously, we just shared the top line at this time.

    顯然,我們此時只是分享了頂線。

  • So I can't go into detailed data, as you know, prior to the data disclosure.

    因此,如您所知,在數據披露之前,我無法深入了解詳細數據。

  • But what I can tell you is that we do believe that the positive results from monarchE are clinically meaningful and will add to the existing body of evidence that Verzenio is differentiated from other CDK4/6s.

    但我可以告訴你的是,我們確實相信 monarchE 的陽性結果具有臨床意義,並將增加現有的證據體系,證明 Verzenio 與其他 CDK4/6 不同。

  • And this is a major milestone for Verzenio and we believe does have the potential to change the paradigm of how early breast cancer is treated.

    這是 Verzenio 的一個重要里程碑,我們相信它確實有可能改變早期乳腺癌的治療模式。

  • So we really look forward to sharing the data with you at a meeting later this year.

    因此,我們非常期待在今年晚些時候的一次會議上與您分享這些數據。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Anne.

    謝謝,安妮。

  • 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

  • Yes.

    是的。

  • Thanks.

    謝謝。

  • And with respect to the tau antibody, again here, I'll just say we're still on track for the data readout.

    關於 tau 抗體,在這裡,我只想說我們仍在進行數據讀出。

  • This will come in the second half of next year.

    這將在明年下半年到來。

  • I'm excited about this mechanism.

    我對這種機制感到興奮。

  • But we don't have clinical data yet.

    但我們還沒有臨床數據。

  • The Roche readout will be important.

    羅氏讀數將很重要。

  • And we'll be watching it carefully.

    我們會仔細觀察。

  • And of course, on behalf of patients and the mechanism, we'll be hoping for their success.

    當然,我們代表患者和機制,希望他們取得成功。

  • But there are some differences, as you pointed out, both in molecule and trial design that make readthrough more complicated.

    但是,正如您所指出的,分子和試驗設計都存在一些差異,這使得通讀更加複雜。

  • One, I think, important aspect of molecule design is that there's lots of different species of tau in the brain.

    一,我認為,分子設計的重要方面是大腦中有許多不同種類的 tau。

  • There's a lot of soluble tau that is monomeric and probably not involved in the pathogenesis of Alzheimer's disease that can sop up antibody and sort of reduce the effective amount of antibody available to get the bad kinds of tau.

    有許多可溶性 tau 是單體的,可能不參與阿爾茨海默病的發病機制,它們可以吸收抗體並減少可用於獲得不良類型 tau 的有效抗體量。

  • Our antibodies are designed specifically to bind aggregated tau.

    我們的抗體專門設計用於結合聚集的 tau。

  • So we think that should improve its ability to actually hit the target.

    所以我們認為應該提高其實際命中目標的能力。

  • Very high doses of these antibodies are generally used to overcome this soluble monomeric tau problem.

    通常使用非常高劑量的這些抗體來克服這種可溶性單體 tau 問題。

  • So that's one difference between that Roche antibody and, in fact, all of the competitors and ours.

    這就是羅氏抗體與事實上所有競爭對手和我們的抗體之間的區別之一。

  • A second difference is around trial design.

    第二個不同之處在於試驗設計。

  • And here again, we've used our unique expertise in tau imaging and biomarkers to select a patient population that we think: a, will be more uniform in its disease progression, allowing us to see signal better; and b, be more likely to be responsive to a tau therapeutic.

    在這裡,我們再次利用我們在 tau 成像和生物標誌物方面的獨特專業知識來選擇我們認為的患者群體:a,其疾病進展將更加一致,使我們能夠更好地看到信號; b,更有可能對 tau 治療有反應。

  • It's likely these therapies will be effective, if they are effective, at stopping the spread of tau rather than removing preformed tau.

    如果這些療法有效的話,它們很可能會有效地阻止 tau 的傳播,而不是去除預先形成的 tau。

  • And so I think it's important to have patients who are in the midst of spreading tau, not patients that tau has spread throughout the entire brain.

    所以我認為重要的是讓患者正在傳播 tau,而不是 tau 已經傳播到整個大腦的患者。

  • So we'll watch them carefully, but they'll be caution on readthroughs.

    所以我們會仔細觀察它們,但他們會謹慎閱讀。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • Steve, thanks for your questions.

    史蒂夫,謝謝你的提問。

  • Operator

    Operator

  • Navin Jacob, UBS.

    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 a couple on some launch products.

    只是一些推出產品的夫婦。

  • Retevmo, selpercatinib, just wondering how that launch is going.

    Retevmo,selpercatinib,只是想知道這次發布的進展如何。

  • What is the diagnosis rate for RET right now?

    現在RET的診斷率是多少?

  • And where do you see that will reach over the next 1 to 2 years?

    您認為未來 1 到 2 年會達到什麼程度?

  • And then just time lines for Retevmo in ex U.S. markets.

    然後是 Retevmo 在美國以外市場的時間線。

  • And then separately, with regards to your migraine franchise, just want to get some color on how you view the CGRP market growing from here going forward as well as tied to that, lasmiditan.

    然後另外,關於您的偏頭痛專營權,只是想了解您如何看待 CGRP 市場從這裡向前發展以及與之相關的增長,lasmiditan。

  • I know it's still early in the launch, but the launch does seem to be a little bit slower than some of the competitors out there.

    我知道現在還處於發布初期,但發布似乎確實比那裡的一些競爭對手慢了一點。

  • Just wondering what the dynamics you're seeing in there, understanding that it's -- that COVID-19 is also making things a little bit challenging in the neurology setting.

    只是想知道您在那裡看到的動態,了解它是 - COVID-19 也在神經病學環境中使事情變得有點挑戰。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Navin.

    謝謝,納文。

  • We'll go to Anne for the question on Retevmo and then Patrik on migraine.

    我們將向 Anne 詢問有關 Retevmo 的問題,然後向 Patrik 詢問有關偏頭痛的問題。

  • Anne E. White - Senior VP & President of Lilly Oncology

    Anne E. White - Senior VP & President of Lilly Oncology

  • Well, thanks, Navin, for the questions on Retevmo.

    好吧,謝謝 Navin,關於 Retevmo 的問題。

  • So the launch is going well, as Dave mentioned in his introduction.

    正如戴夫在他的介紹中提到的那樣,發射進展順利。

  • And so we're encouraged by the early demand signals that we've seen with Retevmo.

    因此,我們對 Retevmo 看到的早期需求信號感到鼓舞。

  • And the initial customer feedback on the data has been very positive.

    最初客戶對數據的反饋非常積極。

  • So they're impressed by the efficacy and the safety data across multiple indications and lines of therapy that we were able to get into the label.

    因此,他們對我們能夠進入標籤的多種適應症和治療線的療效和安全性數據印象深刻。

  • And it's the largest, obviously, RET inhibition population that's been studied in 700 patients.

    顯然,這是在 700 名患者中研究過的最大的 RET 抑制人群。

  • We don't have Rx data to report yet.

    我們還沒有要報告的 Rx 數據。

  • But we're aware of patient starts in a number of our top accounts, which is supported by the downstream channel orders.

    但我們知道,我們的一些頂級賬戶都有耐心的開始,這得到了下游渠道訂單的支持。

  • So it's clear that our first-to-market advantage is resulting in the treatment of patients, who have identified [RET] even in previous testing.

    因此,很明顯,我們的市場先機優勢在於治療患者,這些患者甚至在之前的測試中也發現了 [RET]。

  • So that kind of leads to your question around diagnostic testing.

    因此,這會導致您對診斷測試產生疑問。

  • So what we've seen historically is that RET is showing up on panels probably about 30% of the time.

    所以我們從歷史上看到的是,RET 大約有 30% 的時間出現在面板上。

  • So you've hit on one of the key criterias of the launch is to continue to drive that testing rate up.

    所以你已經達到了發布的關鍵標準之一是繼續提高測試率。

  • And so it's been very much a focus of our efforts, both to work with pathologists out in the U.S. on making sure that they have RET on their panels now, that we have an actional -- very actionable biomarker for them to test against.

    因此,這一直是我們努力的重點,既要與美國的病理學家合作,確保他們現在的面板上有 RET,我們也有一個可操作的 - 非常可操作的生物標誌物供他們測試。

  • Our goal is essentially to eventually see testing rates like we see in some of the other targeted therapies, which approach 80%.

    我們的目標基本上是最終看到測試率,就像我們在其他一些靶向療法中看到的那樣,接近 80%。

  • Now the question that we'll all have to assess is how quickly we can get there.

    現在我們都必須評估的問題是我們能多快到達那裡。

  • But our goal is to drive that up as quickly as we possibly can.

    但我們的目標是盡可能快地推動它。

  • And so that's a big focus of the launch.

    所以這是發布的一個重點。

  • And we have partnerships with Thermo Fisher and Illumina and other things in the works to really drive that up across the industry.

    我們與賽默飛世爾和 Illumina 建立了合作夥伴關係,以及其他正在進行的項目,以真正推動整個行業的發展。

  • Because we do believe that, that's actually the best care for patients, regardless they were treated with Retevmo or other targeted therapies, that we want patients to get the right therapy for them.

    因為我們確實相信,這實際上是對患者最好的護理,無論他們接受的是 Retevmo 還是其他靶向治療,我們希望患者得到適合他們的治療。

  • As far as the time lines, so as you know, we've submitted in Europe.

    就時間線而言,如您所知,我們已在歐洲提交。

  • And so we're waiting regulatory action there.

    所以我們在那裡等待監管行動。

  • That submission was accepted at the beginning of this year.

    該提交於今年年初被接受。

  • And then we look to submit in Japan and China, either late this year or early next.

    然後我們希望在今年年底或明年年初在日本和中國提交。

  • So still working with the regulatory authorities there.

    所以仍在與那裡的監管機構合作。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Anne.

    謝謝,安妮。

  • Patrik?

    帕特里克?

  • 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。

  • Well, the overall CGRP market continue to grow very nicely.

    嗯,整體 CGRP 市場繼續增長得非常好。

  • And when we look at on the market growth year-to-year, we're talking about a growth of 64% versus last year while Emgality actually continued to significantly outperform the market with growth of 151%.

    當我們看市場同比增長時,我們談論的是與去年相比增長了 64%,而 Emgality 實際上繼續以 151% 的增長顯著跑贏市場。

  • And even if we look at the last quarter, we see that the CGRP market continued to grow with 12% despite the significant decline in terms of new-to-brand.

    即使我們看上一季度,我們也看到 CGRP 市場繼續以 12% 的速度增長,儘管新品牌顯著下降。

  • And we continue to remain very confident in the future of Emgality and aiming for a market leadership in the preventive market.

    我們繼續對 Emgality 的未來充滿信心,並致力於在預防市場上佔據市場領導地位。

  • And we see also a strong market leadership, particularly in primary care, where we have expanded our efforts in 2020 and with quite a few new trials.

    我們還看到了強大的市場領導地位,特別是在初級保健領域,我們在 2020 年擴大了我們的努力,並進行了很多新的試驗。

  • So very, very optimistic in terms of the CGRP market for Emgality.

    就 Emgality 的 CGRP 市場而言,非常非常樂觀。

  • If we look at on Reyvow launch, I think it's fair to say that we are not pleased with the performance so far.

    如果我們看看 Reyvow 的發布,我認為可以公平地說,我們對迄今為止的表現並不滿意。

  • But we need to have in mind that we had approximately 1 month in the marketplace prior to we were hit by COVID-19.

    但我們需要記住,在我們被 COVID-19 襲擊之前,我們在市場上大約有 1 個月的時間。

  • And we made a conscious decision to actually pull back from our promotional efforts both in the field as well as in terms of [seating] promotion overall.

    我們做出了一個有意識的決定,實際上退出了我們在現場以及整體[座位]促銷方面的促銷活動。

  • We have started to start up virtual proactive detailing.

    我們已經開始啟動虛擬主動細節。

  • And we remain very confident in the molecule, taking into account that it's the only one that actually can offer a strong relief from the most painful physical symptoms as well as the most troublesome symptoms associated with migraine.

    而且我們仍然對這種分子非常有信心,考慮到它是唯一可以真正有效緩解最痛苦的身體症狀以及與偏頭痛相關的最麻煩症狀的分子。

  • And we know that there is a huge opportunity.

    我們知道這是一個巨大的機會。

  • Out of the 6 million people being treated in the U.S. today, 35% to 40% of those are not responding to the treatments.

    今天在美國接受治療的 600 萬人中,有 35% 到 40% 的人對治療沒有反應。

  • And in terms of efficacy and relief, with one single dose, we believe we have a unique value proposition but still a work to be done -- a lot of work to be done.

    在療效和緩解方面,單劑量,我們相信我們有一個獨特的價值主張,但仍有工作要做——還有很多工作要做。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Patrik.

    謝謝,帕特里克。

  • Navin, thanks for your question.

    納文,謝謝你的提問。

  • Operator

    Operator

  • That's from the line of David Risinger, Morgan Stanley.

    這來自摩根士丹利的大衛·里辛格。

  • 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 two questions, please.

    所以我有兩個問題,請。

  • First, for Dan, if you could just help us understand a little bit better regarding the AbCellera antibody 400-patient Phase II, which was initiated mid-June.

    首先,對於 Dan,如果您能幫助我們更好地了解 AbCelera 抗體 400 患者 II 期,該抗體於 6 月中旬啟動。

  • Just curious, given the primary end point is at day 11, why would results not be revealed until the fourth quarter?

    只是好奇,鑑於主要終點是第 11 天,為什麼要到第四季度才會公佈結果?

  • And then second, for Josh, could you comment on the swings in other income?

    其次,對於 Josh,您能否評論一下其他收入的波動?

  • I guess it's really more on a go-forward basis since you already discussed what happened in the second quarter.

    我想這實際上更像是一個前進的基礎,因為您已經討論了第二季度發生的事情。

  • Just to maybe provide any modeling suggestions to us for modeling other income in future quarters.

    只是為了向我們提供任何建模建議,以便在未來幾個季度對其他收入進行建模。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

  • We'll go to Dan and then Josh.

    我們先去找丹,然後找喬希。

  • 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。

  • Dave, thanks for the question on the timing of the Phase II.

    戴夫,感謝關於第二階段時間安排的問題。

  • You're right.

    你是對的。

  • It's a 400-patient study that initiated last month.

    這是上個月開始的一項針對 400 名患者的研究。

  • It got up to a bit of a slow start.

    它開始有點慢。

  • I think as we saw at that time in the country that pandemic shifted in geographies, we shifted our efforts accordingly.

    我認為,正如我們當時在該國看到的大流行在地域上發生了變化,我們相應地改變了我們的努力。

  • It's now enrolling very quickly.

    現在報名速度很快。

  • The timing of data disclosure depends on that rate of enrollment, though.

    不過,數據披露的時間取決於入學率。

  • So it could, in fact, be sooner than Q4.

    因此,事實上,它可能早於第四季度。

  • I think I'm confident it will be by, of course, sometime during Q4 at the latest.

    我想我有信心最遲在第四季度的某個時候就會出現。

  • As you point out, the day 11 time point is the critical point.

    正如您所指出的,第 11 天的時間點是關鍵點。

  • So 400 patients enrolled and then 11 days later, nasopharyngeal swabs and viral assessment and database lock and analysis and reporting, all that will just take probably a couple of weeks from the end of the study.

    因此,400 名患者入組,然後 11 天后,鼻咽拭子和病毒評估、數據庫鎖定以及分析和報告,所有這些可能只需要從研究結束後的幾週時間。

  • So we'll keep investors updated and the community updated on the progress of the study.

    因此,我們將讓投資者和社區了解研究的最新進展。

  • That's where we are today.

    這就是我們今天所處的位置。

  • 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

  • Thanks.

    謝謝。

  • Yes.

    是的。

  • On our OID, of course, in the first half of the year and particularly in the second quarter, as I mentioned, what we're seeing there is the mark-to-market gains from the roughly $2 billion of investment securities we hold.

    當然,在我們的 OID 上,正如我所提到的,在今年上半年,特別是在第二季度,我們看到的是我們持有的大約 20 億美元投資證券的按市值計價收益。

  • Again, we hold these as a function of business development deals and venture capital deals to stay abreast of breaking science.

    同樣,我們將這些視為業務發展交易和風險投資交易的功能,以跟上突破性科學的步伐。

  • And obviously, we're making good decisions there, at least as of Q2.

    顯然,我們正在那裡做出正確的決定,至少在第二季度是這樣。

  • We don't anticipate or we don't forecast gains going forward there.

    我們不預期或不預測未來的收益。

  • So really, if you keep that neutral, Dave, what we're really thinking about then is we're in a net debt position, so we pay interest costs on the debt.

    所以說真的,如果你保持中立,戴夫,我們真正在想的是我們處於淨債務狀態,所以我們支付債務的利息成本。

  • And then the only way we see anything that's positive is if we see investment gains change.

    然後,我們看到任何積極的東西的唯一方法就是我們看到投資收益發生變化。

  • So I think for modeling purposes, look at our sort of net debt position.

    因此,我認為出於建模目的,請查看我們的淨債務頭寸。

  • We've got great rates against the debt.

    我們的債務利率很高。

  • So it's pretty modest negative cost.

    所以這是相當適度的負成本。

  • But that's sort of what we assume.

    但這就是我們所假設的。

  • And then any unusual items that flow through there, of course, we'll report.

    當然,我們會報告任何流經那裡的不尋常物品。

  • And we tend to just, as you saw on Q2, let those flow through.

    正如您在第二季度看到的那樣,我們傾向於讓這些流過。

  • But we're not anticipating anything significant in the second half of the year.

    但我們預計下半年不會有任何重大事件。

  • So mostly, you're just going to see the negative impacts of our net debt position.

    因此,大多數情況下,您只會看到我們的淨債務狀況的負面影響。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • David, thanks for your questions.

    大衛,謝謝你的提問。

  • And we'll go to Dave for the close.

    我們會去戴夫為結束。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Thanks, Kevin.

    謝謝,凱文。

  • Well, we appreciate your participation in our earnings call today and a remarkable quarter.

    好吧,我們感謝您今天參加我們的財報電話會議和一個非凡的季度。

  • And thank you for your interest in Eli Lilly.

    感謝您對禮來公司的關注。

  • Please follow up with our IR team if you have any additional questions that we didn't address today, and hope everyone stays well, and we'll talk to you soon.

    如果您有任何我們今天沒有解決的其他問題,請與我們的 IR 團隊聯繫,並希望每個人都保持良好狀態,我們會盡快與您聯繫。

  • Operator

    Operator

  • Thank you.

    謝謝你。

  • Ladies and gentlemen, that does conclude your conference.

    女士們先生們,你們的會議到此結束。

  • We do thank you for joining.

    我們非常感謝您的加入。

  • You may now disconnect.

    您現在可以斷開連接。

  • Have a good day.

    祝你有美好的一天。