禮來公司 (LLY) 2019 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q4 2019 Earnings Call.

    女士們,先生們,感謝您的支持,歡迎參加禮來公司 2019 年第四季度財報電話會議。

  • (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'd now like to turn the conference over to your host, Kevin Hern.

    我現在想將會議轉交給您的主持人 Kevin Hern。

  • Please go ahead.

    請繼續。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Good morning.

    早上好。

  • Thank you for joining us for Eli Lilly and Company's Q4 2019 Earnings Call.

    感謝您參加禮來公司 2019 年第四季度財報電話會議。

  • I'm Kevin Hern, Vice President of Investor Relations.

    我是投資者關係副總裁 Kevin Hern。

  • Joining 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.

    禮來(Lilly)董事長兼首席執行官戴夫·里克斯(Dave Ricks)參加了今天的電話會議;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 Kim Macko and Mike Czapar of the Investor Relations team.

    投資者關係團隊的 Kim Macko 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 those 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,包括幻燈片 3 中列出的因素以及我們向證券交易委員會提交的最新表格 10-K、10-Q 和任何 8-K 中概述的因素。

  • 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 2018 and 2019 and present earnings per share as though the full disposition via the exchange offer was complete on January 1, 2018.

    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原則財務指標上,其中不包括 Elanco 在 2018 年和 2019 年的財務貢獻,並呈現每股收益,就好像通過交換要約完成的全部處置2018 年 1 月 1 日。

  • Now I'll turn the call over to Dave for a summary of our Q4 results.

    現在,我將把電話轉給 Dave,以總結我們的第四季度業績。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Thanks, Kevin.

    謝謝,凱文。

  • 2019 was a solid year for Lilly, and our strong Q4 financial results highlight the strength of the underlying business.

    2019 年對禮來來說是穩健的一年,我們強勁的第四季度財務業績突顯了基礎業務的實力。

  • We exited 2019 with momentum, and we'll continue to focus on executing our strategy in 2020, which is to deliver excellent business results, develop and launch new medicines for patients and drive increased productivity.

    我們以勢頭結束了 2019 年,我們將繼續專注於在 2020 年執行我們的戰略,即提供出色的業務成果,為患者開發和推出新藥並提高生產力。

  • Revenue growth accelerated in Q4, increasing 8% versus Q4 2018 or 9% in constant currency.

    第四季度收入增長加速,與 2018 年第四季度相比增長 8%,按固定匯率計算增長 9%。

  • This strong performance was driven entirely by volume, which contributed 10 percentage points of growth despite continued headwinds from the loss of exclusivity in the U.S. of Cialis and the global withdrawal of Lartruvo.

    這種強勁的表現完全是由銷量推動的,儘管 Cialis 在美國失去排他性和拉特魯沃全球撤出帶來持續不利因素,但銷量仍貢獻了 10 個百分點的增長。

  • Excluding Cialis and Lartruvo, worldwide volume growth was an impressive 15%.

    不包括 Cialis 和 Lartruvo,全球銷量增長了 15%,令人印象深刻。

  • Newer medicines continue to be our growth engine, representing 46% of our revenue this quarter.

    新藥繼續成為我們的增長引擎,占我們本季度收入的 46%。

  • We made good progress in Q4 on our productivity agenda as operating income grew 10% versus last year.

    由於營業收入與去年相比增長了 10%,我們在第四季度的生產力議程上取得了良好進展。

  • We posted strong revenue growth and held marketing, selling and administrative expenses flat versus last year while increasing our investment in R&D.

    我們公佈了強勁的收入增長,營銷、銷售和管理費用與去年持平,同時增加了對研發的投資。

  • Our non-GAAP operating margin was 26.3%, an improvement of 40 basis points versus Q4 2018.

    我們的非公認會計原則營業利潤率為 26.3%,與 2018 年第四季度相比提高了 40 個基點。

  • We finished 2019 with a full year operating margin slightly below our guidance of approximately 28% as we made targeted strategic investments in Q4 across both our commercial portfolio and pipeline, which will enhance our opportunities for future growth.

    我們在 2019 年結束時的全年營業利潤率略低於我們約 28% 的指導,因為我們在第四季度對我們的商業組合和管道進行了有針對性的戰略投資,這將增加我們未來增長的機會。

  • These investments provide good momentum heading into 2020 and keep us on track to achieve our 31% operating margin target this year.

    這些投資為進入 2020 年提供了良好的動力,並使我們有望在今年實現 31% 的營業利潤率目標。

  • We've announced multiple pipeline milestones since our Q3 earnings call.

    自第三季度財報電話會議以來,我們已經宣布了多個管道里程碑。

  • These include positive results in the remaining 2 Phase III trials of the baricitinib BREEZE-AD program in atopic dermatitis, the submission of selpercatinib in the U.S. and Europe and the FDA granting selpercatinib a priority review, the submission of tanezumab for OA pain in the U.S. in collaboration with Pfizer, the submission of higher doses of Trulicity in the U.S. and Europe and the submission of baricitinib for atopic dermatitis in Europe and Japan.

    其中包括巴瑞克替尼 BREEZE-AD 項目在特應性皮炎中的剩餘 2 項 III 期試驗的積極結果,在美國和歐洲提交 selpercatinib 以及 FDA 授予 selpercatinib 優先審查,在美國提交 tanezumab 治療 OA 疼痛。與輝瑞合作,在美國和歐洲提交更高劑量的 Trulicity,在歐洲和日本提交用於治療特應性皮炎的巴瑞替尼。

  • During Q4, we put our strong operating cash flow to work, returning approximately $900 million to shareholders via share repurchase and dividend.

    在第四季度,我們將強勁的經營現金流投入使用,通過股票回購和股息向股東返還約 9 億美元。

  • In addition, as previously announced, we increased our dividend 15% for 2020.

    此外,正如之前宣布的,我們將 2020 年的股息提高了 15%。

  • This marks the second consecutive year of a 15% dividend increase, reflecting our confidence in the outlook for the business.

    這標誌著股息連續第二年增長 15%,反映了我們對業務前景的信心。

  • Finally, we recently announced the pending acquisition of Dermira, a company focused on developing new therapies for chronic skin conditions.

    最後,我們最近宣布即將收購 Dermira,這是一家專注於開發慢性皮膚病新療法的公司。

  • Dermira has an exciting asset in Phase III for atopic dermatitis, lebrikizumab, in addition to a currently marketed product for excessive underarm sweating, QBREXZA.

    除了目前銷售的用於治療腋下過度出汗的產品 QBREXZA 外,Dermira 在特應性皮炎 III 期還擁有令人興奮的資產 lebrikizumab。

  • This transaction enhances our Phase III pipeline and complements our existing efforts in atopic dermatitis with baricitinib.

    此次交易增強了我們的 III 期管道,並補充了我們現有的巴瑞替尼在特應性皮炎方面的努力。

  • We look forward to closing that transaction here in Q1.

    我們期待在第一季度完成該交易。

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

    轉到幻燈片 5,您將看到自我們上次財報電話會議以來的關鍵事件列表。

  • In our continued efforts to help make medicines more affordable and reduce out-of-pocket costs for patients, we recently announced plans to introduce 2 additional lower-priced insulins: Humalog 75/25 KwikPen and Humalog Junior KwikPen.

    在我們繼續努力幫助患者更負擔得起藥物並降低自付費用的過程中,我們最近宣布計劃推出另外兩種價格較低的胰島素:Humalog 75/25 KwikPen 和 Humalog Junior KwikPen。

  • Both products will be available by mid-April and will be offered at a 50% lower list price compared to the branded versions.

    這兩款產品將於 4 月中旬上市,與品牌版本相比,標價將降低 50%。

  • Once these additional options are available, more than 90% of Lilly's Humalog options will be accessible to help patients reduce their out-of-pocket costs.

    一旦這些附加選項可用,禮來公司 90% 以上的 Humalog 選項將可用於幫助患者降低自付費用。

  • And we hope to see payers provide increased access to patients for these solutions.

    我們希望看到付款人為這些解決方案提供更多的患者訪問權限。

  • During the month of December alone, Insulin Lispro helped nearly 79,000 patients in the U.S. These recent additions complement existing offerings in the Lilly Diabetes Solution Center, which includes -- which currently helps as many as 20,000 patients per month better afford their insulin.

    僅在 12 月份,賴脯胰島素就幫助了美國近 79,000 名患者。這些最近增加的產品補充了禮來糖尿病解決方案中心的現有產品,其中包括 - 目前每月幫助多達 20,000 名患者更好地負擔他們的胰島素。

  • As a company that has been in business for over 140 years and invests over $5 billion per year in long-term research and development, we take our responsibility to pursue sustainable business, social and environmental practices very seriously.

    作為一家經營了 140 多年、每年投資超過 50 億美元用於長期研發的公司,我們非常重視追求可持續商業、社會和環境實踐的責任。

  • Now I'll turn the call over to Josh to review our Q4 results and to provide an update on our 2020 financial guidance.

    現在,我將把電話轉給喬什,以審查我們的第四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.

    謝謝,戴夫。

  • Slide 6 summarizes our presentation of GAAP results and non-GAAP measures, and Slide 7 provides a summary of our GAAP results.

    幻燈片 6 總結了我們對 GAAP 結果和非 GAAP 措施的介紹,幻燈片 7 總結了我們的 GAAP 結果。

  • So looking at the non-GAAP measures on Slide 8, you'll see revenue increased 8% or 9% in constant currency.

    所以看看幻燈片 8 上的非 GAAP 指標,您會看到收入增長了 8% 或 9%(按固定匯率計算)。

  • Gross margin as a percent of revenue declined 70 basis points to 79.9%.

    毛利率佔收入的百分比下降 70 個基點至 79.9%。

  • Excluding the impact of FX on international inventories sold, gross margin as a percent of revenue was 79.6%.

    排除外匯對已售國際庫存的影響,毛利率佔收入的百分比為 79.6%。

  • And on the same basis, our gross margin percent decreased by approximately 50 basis points compared to Q4 2018 driven by unfavorable product mix and the negative impact of price on revenue.

    在同樣的基礎上,由於不利的產品組合和價格對收入的負面影響,與 2018 年第四季度相比,我們的毛利率下降了約 50 個基點。

  • Moving down the P&L.

    向下移動損益表。

  • Operating expenses grew 6% versus last year's quarter.

    與去年同期相比,運營費用增長了 6%。

  • Marketing, selling and administrative expenses were flat as cost containment and productivity measures offset investments in key growth products.

    由於成本控制和生產力措施抵消了對關鍵增長產品的投資,營銷、銷售和管理費用持平。

  • R&D expenses increased 14%, reflecting higher development expenses for late-stage assets, including tirzepatide, selpercatinib and mirikizumab.

    研發費用增長 14%,反映後期資產的開發費用增加,包括 tirzepatide、selpercatinib 和 mirikizumab。

  • Operating income increased 10% compared to Q4 2018 as sales growth outpaced expense growth, resulting in operating income as a percent of revenue of 26.3% for the quarter and 27.2% for the full year.

    與 2018 年第四季度相比,營業收入增長了 10%,因為銷售額增長超過了支出增長,導致本季度營業收入佔收入的百分比為 26.3%,全年為 27.2%。

  • This quarter's results are indicative of the potential for growth and margin expansion our portfolio of medicines offers.

    本季度的業績表明我們提供的藥物組合具有增長和利潤率擴張的潛力。

  • We are well positioned to drive top-tier revenue growth and invest in the next wave of new medicines while driving margin expansion at the same time.

    我們有能力推動頂級收入增長並投資於下一波新藥,同時推動利潤率擴張。

  • We exit 2019 with significant momentum executing our strategy and are on track to achieve our 2020 full year operating margin target of 31%.

    2019 年,我們執行戰略的勢頭強勁,有望實現 2020 年全年 31% 的營業利潤率目標。

  • Other income and expense was income of $206 million this quarter compared to income of $31 million in Q4 2018 driven by investment gains on public equities.

    其他收入和支出是本季度的收入為 2.06 億美元,而 2018 年第四季度的收入為 3100 萬美元,主要受公共股票投資收益的推動。

  • As we highlighted previously, this line item can be volatile as public market valuations fluctuate.

    正如我們之前強調的那樣,隨著公開市場估值的波動,該項目可能會出現波動。

  • Gains in Q4 were primarily generated by our investments in China biotech companies through our Lilly Asia Ventures arm and strategic investments in companies focused in newer technologies like RNAi.

    第四季度的收益主要來自我們通過禮來亞洲風險投資部門對中國生物技術公司的投資以及對專注於 RNAi 等新技術的公司的戰略投資。

  • While we appreciate the gains, we are even more pleased with the relationships and the potential to develop new medicines for patients that accompany some of these investments.

    雖然我們很欣賞這些收益,但我們對伴隨其中一些投資的關係和為患者開發新藥的潛力感到更加滿意。

  • Our tax rate was 12.6%, a decrease of 300 basis points compared with the same quarter last year driven primarily by an increase in net discrete tax benefits, including tax benefits from the resolution of U.S. and foreign audits.

    我們的稅率為 12.6%,與去年同期相比下降了 300 個基點,主要是由於淨離散稅收優惠增加,包括美國和外國審計決議帶來的稅收優惠。

  • At the bottom line, net increased -- net income increased 26% while earnings per share increased 31% due to a reduction in shares outstanding from share repurchases.

    歸根結底,淨增加——淨收入增加了 26%,而每股收益增加了 31%,原因是股票回購導致的流通股減少。

  • Slide 9 outlines these same non-GAAP measures for the full year.

    幻燈片 9 概述了全年這些相同的非公認會計原則措施。

  • While we are excited with our performance in Q4 and the momentum headed into 2020, we're also pleased with our overall performance for the full year in 2019.

    雖然我們對第四季度的表現和進入 2020 年的勢頭感到興奮,但我們也對 2019 年全年的整體表現感到滿意。

  • Last year, we experienced the full effect of the Cialis patent expiration and the impact of the withdrawal of Lartruvo.

    去年,我們經歷了 Cialis 專利到期的全面影響和 Lartruvo 退出的影響。

  • In spite of these headwinds, we grew the top line at 5% in constant currency and generated EPS growth of 11% while investing behind our newer products and pipeline.

    儘管存在這些不利因素,我們以固定匯率計算的收入增長了 5%,每股收益增長了 11%,同時投資於我們的新產品和管道。

  • We also generated good shareholder value and established a strong strategic foundation through our split-off of Elanco and the acquisition of Loxo Oncology.

    我們還通過拆分 Elanco 和收購 Loxo Oncology 創造了良好的股東價值並建立了強大的戰略基礎。

  • As we highlighted in December last year, we are well positioned in 2020 to deliver our 5-year financial goals and continue this period of sustained growth.

    正如我們在去年 12 月強調的那樣,我們已做好準備在 2020 年實現我們的 5 年財務目標並繼續這一持續增長期。

  • Moving to Slide 10, you'll find a reconciliation between reported and non-GAAP EPS.

    轉到幻燈片 10,您會發現報告的每股收益和非公認會計準則每股收益之間的對賬。

  • Additional details are provided on Slides 26 and 27.

    幻燈片 26 和 27 提供了更多詳細信息。

  • On Slide 11, we quantify the effect of price, rate and volume on revenue growth.

    在幻燈片 11 中,我們量化了價格、費率和銷量對收入增長的影響。

  • As mentioned earlier, worldwide revenue grew 9% in constant currency during Q4 driven by strong volume growth of 10% partially offset by price.

    如前所述,由於 10% 的強勁銷量增長被價格部分抵消,第四季度全球收入按固定匯率計算增長了 9%。

  • Foreign exchange had a modest negative impact on revenue growth.

    外匯對收入增長產生了適度的負面影響。

  • For the fourth straight year, we delivered worldwide revenue growth each quarter despite headwinds from patent expirations.

    儘管專利到期帶來了不利影響,我們連續第四年實現了每個季度的全球收入增長。

  • U.S. revenue grew 7% compared with the fourth quarter of 2018.

    與 2018 年第四季度相比,美國收入增長了 7%。

  • Volume growth of 8% was led by Trulicity, Taltz, Verzenio, Jardiance and Emgality.

    Trulicity、Taltz、Verzenio、Jardiance 和 Emgality 引領了 8% 的銷量增長。

  • Excluding Cialis and Lartruvo, volume grew over 15%.

    不包括 Cialis 和 Lartruvo,銷量增長超過 15%。

  • Pricing was a 1% drag on U.S. revenue growth this quarter, impacted by increased funding during the coverage gap in Medicare, unfavorable changes in estimates for rebates and discounts and disproportionate volume growth in lower net price segments, which was partially offset by the net of modest list price increases and higher rebates as well as reduced reliance on patient assistance programs primarily due to improved commercial access for Emgality.

    定價對本季度美國收入增長造成 1% 的拖累,原因是醫療保險覆蓋缺口期間資金增加、回扣和折扣估計的不利變化以及較低淨價格部分的銷量增長不成比例,這部分被適度的標價上漲和更高的回扣以及減少對患者援助計劃的依賴,主要是由於 Emgality 的商業准入得到改善。

  • The full year impact of price was a headwind of 3%, consistent with our 2019 and 2020 expectations for U.S. price having a moderate drag on revenue growth.

    價格對全年的影響為 3%,與我們 2019 年和 2020 年對美國價格適度拖累收入增長的預期一致。

  • Moving to Europe.

    搬到歐洲。

  • Revenue grew 12% in constant currency driven by impressive 15% volume growth, partially offset by the negative effect of foreign exchange and price.

    在銷量增長 15% 的推動下,收入增長了 12%,但部分被外彙和價格的負面影響所抵消。

  • Volume growth was led by Trulicity, Olumiant, Taltz and Verzenio.

    銷量增長由 Trulicity、Olumiant、Taltz 和 Verzenio 引領。

  • We're pleased with the uptake of our new products across Europe and are looking forward to continued strong growth in 2020.

    我們對我們的新產品在歐洲的採用感到高興,並期待在 2020 年繼續強勁增長。

  • In Japan, revenue grew 7% in constant currency driven entirely by volume growth somewhat offset by a modest pricing headwind due to the government-mandated price decreases that went into effect in 2019.

    在日本,以固定匯率計算的收入增長了 7%,這完全是由於 2019 年生效的政府強制降價導致的適度定價逆風,這在一定程度上抵消了銷量增長的推動。

  • Verzenio, Cymbalta, Trulicity and Olumiant were the key contributors to growth.

    Verzenio、Cymbalta、Trulicity 和 Olumiant 是增長的主要貢獻者。

  • Revenue in the rest of the world increased $0.14 in constant currency, led by 44% growth in China on the same basis.

    世界其他地區的收入按固定匯率計算增加了 0.14 美元,其中中國在相同基礎上增長了 44%。

  • China growth was driven by strong performance across a number of key products, including Tyvyt, and we're excited about the recent launches of Trulicity, Taltz and Olumiant.

    中國的增長是由包括 Tyvyt 在內的許多關鍵產品的強勁表現推動的,我們對最近推出的 Trulicity、Taltz 和 Olumiant 感到興奮。

  • The same information for our full year revenue is at the bottom of the slide.

    我們全年收入的相同信息位於幻燈片底部。

  • As shown on Slide 12, our key growth products continue to drive impressive worldwide volume growth.

    如幻燈片 12 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 nearly 15 percentage points of growth this quarter, continuing the strong trajectory we've seen throughout 2019.

    這些新藥在本季度實現了近 15 個百分點的增長,延續了我們在 2019 年全年看到的強勁勢頭。

  • Brands that have experienced loss of exclusivity provided a drag of over 400 basis points driven primarily by Cialis.

    經歷過排他性損失的品牌拖累了 400 多個基點,主要由 Cialis 驅動。

  • As a reminder, generic tadalafil entered the U.S. market in September 2018, significantly impacting Cialis revenue with erosion further accelerating in Q2 2019 as multisource generics entered the market.

    提醒一下,仿製藥他達拉非於 2018 年 9 月進入美國市場,隨著多源仿製藥進入市場,2019 年第二季度的侵蝕進一步加速,對 Cialis 的收入產生了重大影響。

  • While the impact of this event is beginning to sunset, it still had a meaningful negative impact on growth in Q4 2019.

    雖然這一事件的影響開始消退,但它仍然對 2019 年第四季度的增長產生了有意義的負面影響。

  • Slide 13 highlights the contribution of our key growth products.

    幻燈片 13 突出了我們主要增長產品的貢獻。

  • In total, these brands generated over $2.8 billion in revenue this quarter, making up 46% of revenue.

    這些品牌本季度的總收入超過 28 億美元,佔收入的 46%。

  • Our newest medicines again had impressive results in large and growing therapeutic areas, and our ability to reach more patients continues to demonstrate the strength of our commercial execution.

    我們的最新藥物再次在大型且不斷增長的治療領域取得了令人矚目的成果,我們接觸更多患者的能力繼續證明我們商業執行的實力。

  • Within diabetes, the injectable GLP-1 class continues to add new patients despite the entry of a new oral therapy.

    在糖尿病中,儘管引入了新的口服療法,可注射的 GLP-1 類藥物仍在繼續增加新患者。

  • In the U.S., total injectable GLP prescriptions grew 29% versus Q4 2018; and Trulicity grew faster than the market, posting an increase of 32% in total prescriptions during the same period.

    在美國,可注射 GLP 處方總量與 2018 年第四季度相比增長了 29%;和 Trulicity 的增長速度快於市場,同期總處方量增長了 32%。

  • Net pricing in the U.S. for Trulicity declined in the mid-single digits, in line with our expectations for Q4 and for 2020.

    Trulicity 在美國的淨定價以中個位數下降,符合我們對第四季度和 2020 年的預期。

  • As we discussed on the Q3 call, Trulicity price in Q1 through Q3 of 2019 was impacted by a number of factors that we don't expect to persist in 2020.

    正如我們在第三季度電話會議上所討論的那樣,2019 年第一季度至第三季度的 Trulicity 價格受到了我們預計在 2020 年不會持續存在的許多因素的影響。

  • SGLT2 inhibitors accelerated their trajectory as total U.S. prescriptions for the class grew nearly 20% versus last year's quarter and new therapy starts grew over 46%.

    SGLT2抑製劑加速了它們的發展軌跡,美國對該類藥物的總處方與去年同期相比增長了近 20%,新療法的開工量增長了 46% 以上。

  • As the market leader, Jardiance continues to drive strong class growth and accounts for over 55% of total prescriptions.

    作為市場領導者,Jardiance 繼續推動類別的強勁增長,佔總處方的 55% 以上。

  • Our sustained market leadership in these 2 important and growing classes within diabetes is a competitive advantage for our diabetes business and positions us well for future growth.

    我們在糖尿病領域這兩個重要且不斷增長的類別中的持續市場領導地位是我們糖尿病業務的競爭優勢,並使我們為未來的增長做好準備。

  • In immunology, Taltz continues to have strong growth.

    在免疫學方面,Taltz 繼續保持強勁增長。

  • U.S. total prescriptions grew nearly 40% versus Q4 2018.

    與 2018 年第四季度相比,美國的總處方量增長了近 40%。

  • Despite an increasingly competitive market, Taltz gained over 3 share points in dermatology during 2019, and rheumatology weekly prescriptions have more than doubled during that same time frame.

    儘管市場競爭日益激烈,但 Taltz 在 2019 年期間在皮膚科獲得了超過 3 個份額,而在同一時間段內,風濕科每周處方增加了一倍以上。

  • In 2020, we look to build on the strong momentum demonstrated in 2019 and reach even more patients.

    2020 年,我們希望在 2019 年表現出的強勁勢頭的基礎上再接再厲,惠及更多患者。

  • In pain, Emgality continued its U.S. leadership in share of market for new-to-brand prescription at over 47%.

    痛苦的是, Emgality 繼續保持其在美國新品牌處方市場份額超過 47% 的領先地位。

  • While pleased with the uptake, we believe there is room for significant additional growth as we expand our commercial presence in primary care.

    雖然對吸收率感到滿意,但我們相信隨著我們擴大在初級保健領域的商業存在,還有顯著的額外增長空間。

  • We continue to see progress with roughly 80% of prescriptions reimbursed at the end of Q4, reflecting the strong access of Emgality.

    我們繼續看到進展,在第四季度末報銷了大約 80% 的處方,這反映了 Emgality 的強大准入。

  • Within oncology, Verzenio U.S. total prescriptions grew over 46% versus Q4 2018, and the CDK 4 and 6 market is showing encouraging growth as total prescriptions increased by over 16% during the same time frame.

    在腫瘤領域,Verzenio 美國的總處方量與 2018 年第四季度相比增長了 46% 以上,而 CDK 4 和 6 市場的增長令人鼓舞,因為同期總處方量增加了 16% 以上。

  • Additionally, Cyramza continues to post solid growth as we realize thoracic synergies across our portfolio.

    此外,隨著我們在我們的產品組合中實現胸部協同效應,Cyramza 繼續實現穩健增長。

  • In addition to the strong performance of our key growth drivers, we look forward to potentially launching 3 new medicines in 2020 with Reyvow, selpercatinib and Ultra Rapid Lispro.

    除了我們關鍵增長動力的強勁表現,我們期待在 2020 年推出 3 種新藥,包括 Reyvow、selpercatinib 和 Ultra Rapid Lispro。

  • We believe all 3 new medicines have potential to be first-in-class or best-in-class and to improve the lives of patients.

    我們相信所有 3 種新藥都有潛力成為一流或一流的,並改善患者的生活。

  • In addition, launching new medicines in the therapeutic areas where we have existing commercial infrastructure will support further margin expansion.

    此外,在我們現有商業基礎設施的治療領域推出新藥將支持進一步擴大利潤。

  • Slide 14 shows the year-over-year change in select lines of our income statement.

    幻燈片 14 顯示了我們損益表中特定行的同比變化。

  • Focusing on our non-GAAP results, foreign exchange rates had a modest negative impact on revenue, gross margin, operating income and EPS and a modest net positive impact on operating expenses.

    著眼於我們的非公認會計原則結果,匯率對收入、毛利率、營業收入和每股收益產生了適度的負面影響,對運營費用產生了適度的淨正面影響。

  • On Slide 15, we provide an update on capital allocation.

    在幻燈片 15 上,我們提供了資本配置的最新信息。

  • In 2019, we invested over $13 billion to drive our future growth through a combination of business development, capital expenditures and after-tax investment in R&D.

    2019 年,我們投資超過 130 億美元,通過業務發展、資本支出和研發的稅後投資相結合來推動我們的未來增長。

  • In addition, we returned approximately $7 billion to shareholders via dividend and share repurchase.

    此外,我們通過股息和股票回購向股東返還了大約 70 億美元。

  • As Dave mentioned earlier, we also announced a 15% dividend increase for the second consecutive year, showing our confidence in the outlook for the company.

    正如戴夫之前提到的,我們還宣布連續第二年增加 15% 的股息,顯示了我們對公司前景的信心。

  • We are focused on utilizing the strong cash flow our business generates to develop the next wave of new medicines through both internal and external sources as highlighted by the recently announced acquisition of Dermira.

    正如最近宣布的對 Dermira 的收購所強調的那樣,我們專注於利用我們業務產生的強勁現金流通過內部和外部資源開發下一波新藥。

  • We remain active in assessing bolt-on acquisitions or in-licensing where we can create shareholder value and enhance our future growth prospects.

    我們仍然積極評估附加收購或許可,我們可以在這些方面創造股東價值並增強我們未來的增長前景。

  • Turning to our 2020 financial guidance on Slide 16.

    轉向我們在幻燈片 16 上的 2020 年財務指導。

  • You'll see that we've updated our non-GAAP guidance to reflect the impact of the planned acquisition of Dermira and our recent strong business performance.

    您會看到我們更新了我們的非公認會計原則指南,以反映計劃收購 Dermira 的影響以及我們近期強勁的業務表現。

  • Specifically, we're increasing our revenue range by $100 million to include QBREXZA and to reflect strong prescription trends we see in the underlying business, updating our SG&A guidance to account for the addition of the Dermira sales force and the commercial expenses to support QBREXZA and maintaining all other line items in confirming our non-GAAP earnings per share range of $6.70 to $6.80 and operating margin target of 31%.

    具體來說,我們將收入範圍增加 1 億美元,以包括 QBREXZA 並反映我們在基礎業務中看到的強勁處方趨勢,更新我們的 SG&A 指導以考慮增加 Dermira 銷售隊伍和支持 QBREXZA 的商業費用和維持所有其他項目,以確認我們的非公認會計原則每股收益範圍為 6.70 美元至 6.80 美元,營業利潤率目標為 31%。

  • On a reported basis, the impact of the Dermira acquisition will have an impact of $0.21 and earnings per share for 2020 is now expected to be in the range of $6.18 to $6.28.

    據報導,收購 Dermira 將產生 0.21 美元的影響,預計 2020 年的每股收益將在 6.18 美元至 6.28 美元之間。

  • We continue to execute our innovation-based strategy while leveraging our young commercial portfolio of new medicines to drive margin expansion over the midterm.

    我們繼續執行以創新為基礎的戰略,同時利用我們年輕的新藥商業組合來推動中期利潤增長。

  • Now I will turn the call over to Dan to highlight our progress on R&D.

    現在我將把電話轉給 Dan 來強調我們在研發方面的進展。

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Thanks, Josh.

    謝謝,喬希。

  • Slide 17 shows select pipeline opportunities as of January 27.

    幻燈片 17 顯示了截至 1 月 27 日的選定管道機會。

  • Positive movement since our last earnings call includes: the submission of selpercatinib in the U.S. and Europe as well as the initiation of Phase III trials for selpercatinib in patients with RET fusion-positive non-small cell lung cancer or RET-mutant medullary thyroid cancer; the submission of tanezumab in the U.S. for osteoarthritis pain; the submission of higher doses of Trulicity for type 2 diabetes in the U.S. and Europe; the submission of baricitinib for atopic dermatitis in Europe and Japan; the addition of lebrikizumab for atopic dermatitis to the Phase III portfolio pending the closure of the Dermira acquisition; the initiation of a Phase III study of tirzepatide in obesity and a Phase II study of tirzepatide in NASH; the initiation of Phase II for our checkpoint agonist, CD200R, in immunology; and the initiation of Phase I for 4 assets as well as the termination of 3 early-stage oncology assets.

    自我們上次財報電話會議以來的積極進展包括:在美國和歐洲提交 selpercatinib 以及在 RET 融合陽性非小細胞肺癌或 RET 突變甲狀腺髓樣癌患者中啟動 selpercatinib 的 III 期試驗;在美國提交 tanezumab 用於治療骨關節炎疼痛;在美國和歐洲提交更高劑量的 Trulicity 治療 2 型糖尿病;在歐洲和日本提交用於治療特應性皮炎的巴瑞替尼;在完成對 Dermira 的收購之前,將用於特應性皮炎的 lebrikizumab 添加到 III 期產品組合中; tirzepatide 在肥胖症中的 III 期研究和 tirzepatide 在 NASH 中的 II 期研究的啟動;我們的免疫學檢查點激動劑 CD200R 的 II 期啟動; 4項資產的第一階段啟動以及3項早期腫瘤資產的終止。

  • In addition, we had some important early-stage readouts, including LOXO-305, our novel BTK inhibitor, which we highlighted on the 2020 financial guidance call and continues to progress quickly in development.

    此外,我們還有一些重要的早期讀數,包括我們的新型 BTK 抑製劑 LOXO-305,我們在 2020 年財務指導電話會議上強調了這一點,並在開發中繼續快速進展。

  • We also had internal data readouts from 2 Phase II trials of pegilodecakin in combination with immunotherapy agents in patients with non-small cell lung cancer, Cypress 1 and Cypress 2. Although the full data will be presented at a medical meeting later this year, I can say that both studies were negative.

    我們還獲得了 pegilodecakin 與免疫治療藥物聯合用於非小細胞肺癌 Cypress 1 和 Cypress 2 患者的 2 項 II 期試驗的內部數據讀數。雖然完整數據將在今年晚些時候的醫學會議上公佈,但我可以說這兩項研究都是負面的。

  • Though we are disappointed in the lack of efficacy for pegilodecakin in combination with checkpoint inhibition in lung cancer, we remain committed to finding new therapies for people with cancer.

    儘管我們對 pegilodecakin 聯合檢查點抑制在肺癌中缺乏療效感到失望,但我們仍然致力於為癌症患者尋找新的療法。

  • Although we're still analyzing the totality of the data that we have obtained with pegilodecakin, at present, we do not anticipate additional trials with this agent.

    儘管我們仍在分析我們使用 pegilodecakin 獲得的全部數據,但目前,我們預計不會對該藥物進行額外的試驗。

  • Moving to Slide 18.

    轉到幻燈片 18。

  • We show a final tally of how we finished 2019 versus the key events we expected to occur.

    我們展示了我們如何完成 2019 年與我們預期會發生的關鍵事件的最終統計。

  • 2019 was a very productive year, and we made significant progress in bringing new medicines to patients.

    2019 年是豐收的一年,我們在為患者提供新藥方面取得了重大進展。

  • In total, we added 4 new Phase III clinical programs to our pipeline, all with the potential to be first-in-class or best-in-class.

    總的來說,我們在我們的管道中增加了 4 個新的 III 期臨床項目,所有項目都有可能成為一流或一流的。

  • We reported 12 positive Phase III or registrational trial readouts, including a mix of NMEs and new indications or new data for launched products.

    我們報告了 12 個積極的 III 期或註冊試驗讀數,包括 NME 和新適應症或已推出產品的新數據的混合。

  • We submitted 12 NMEs or new indications for regulatory review in geographies around the world.

    我們提交了 12 種 NME 或新適應症,供全球各地的監管審查。

  • And we received positive regulatory action on 2 new medicines, Reyvow and Baqsimi, as well as 4 important new indications across Trulicity, Taltz, Emgality and Cyramza.

    我們收到了對 2 種新藥 Reyvow 和 Baqsimi 的積極監管行動,以及 Trulicity 、 Taltz 、 Emgality 和 Cyramza 的 4 個重要新適應症。

  • We're proud of the significant achievements we made in 2019, and we're focused on discovering and developing more new medicines to help patients as we enter another promising decade.

    我們為 2019 年取得的重大成就感到自豪,並且在進入另一個充滿希望的十年之際,我們專注於發現和開發更多新藥來幫助患者。

  • Moving to Slide 19.

    轉到幻燈片 19。

  • While it's early in the year, we've already made good progress on our 2020 goals having announced the initiation of additional Phase III trials for selpercatinib; positive results in the remaining 2 trials of the baricitinib BREEZE program for atopic dermatitis; the submission of baricitinib for atopic dermatitis in the EU and Japan; the submission of tanezumab for osteoarthritis pain in the U.S. in collaboration with Pfizer; FDA approval of Trijardy, a fixed-dose combination of empagliflozin, linagliptin and metformin XR; and regulatory approval of Cyramza for first-line EGFR-positive non-small cell lung cancer in Europe.

    雖然現在是年初,但我們已經在 2020 年目標上取得了良好進展,宣布啟動額外的 selpercatinib III 期試驗;其餘 2 項針對特應性皮炎的巴瑞克替尼 BREEZE 計劃試驗的陽性結果;在歐盟和日本提交用於特應性皮炎的巴瑞替尼;與輝瑞合作在美國提交 tanezumab 治療骨關節炎疼痛; FDA 批准 Trijardy,這是一種依格列淨、利格列汀和二甲雙胍 XR 的固定劑量組合; Cyramza 在歐洲的一線 EGFR 陽性非小細胞肺癌的監管批准。

  • Before turning the call back over to Dave, I'd like to spend a few minutes providing additional details on important milestones for 2 clinical programs that I mentioned earlier, that is the initiation of additional clinical trials for tirzepatide and the completion of the baricitinib BREEZE-AD atopic dermatitis program.

    在將電話轉回 Dave 之前,我想花幾分鐘時間提供有關我之前提到的 2 個臨床項目的重要里程碑的更多詳細信息,即啟動 tirzepatide 的其他臨床試驗和完成 baricitinib BREEZE -AD特應性皮炎計劃。

  • Beginning with tirzepatide on Slide 20.

    從幻燈片 20 上的替西帕肽開始。

  • We previously shared our plans to initiate a cardiovascular outcome study for tirzepatide this year, assessing tirzepatide head-to-head against the most widely used GLP-1 therapy, i.e., Trulicity.

    我們之前分享了我們計劃在今年啟動一項針對 tirzepatide 的心血管結局研究,評估 tirzepatide 與最廣泛使用的 GLP-1 療法(即 Trulicity)的正面對比。

  • This is a bold move.

    這是一個大膽的舉動。

  • It signals both our confidence in the strength of tirzepatide as well as our desire to deliver meaningful data for patients and physicians on how new medicines measure against leading therapies.

    它既表明了我們對 tirzepatide 強度的信心,也表明了我們希望為患者和醫生提供有關新藥如何衡量領先療法的有意義數據的願望。

  • Through very collaborative discussions with the FDA, we've gained alignment on the key design features of this unique study called SURPASS CVOT.

    通過與 FDA 的非常合作的討論,我們在這項名為 SURPASS CVOT 的獨特研究的關鍵設計特徵上取得了一致。

  • This trial will include approximately 12,500 patients with type 2 diabetes and confirmed atherosclerotic cardiovascular disease and will measure time to first occurrence of the composite end point of CV death, myocardial infarction or stroke.

    該試驗將包括大約 12,500 名患有 2 型糖尿病並確診為動脈粥樣硬化性心血管疾病的患者,並將測量到首次發生 CV 死亡、心肌梗塞或中風的複合終點的時間。

  • The study will assess both noninferiority and superiority of tirzepatide versus Trulicity, and we anticipate it will take just over 4 years to complete.

    該研究將評估 tirzepatide 與 Trulicity 的非劣效性和優越性,我們預計將需要 4 年多的時間才能完成。

  • In addition to SURPASS CVOT, we're pleased to share that the Phase III type 2 diabetes program, SURPASS, is progressing extremely well.

    除了 SURPASS CVOT,我們很高興地分享 III 期 2 型糖尿病計劃 SURPASS 進展非常順利。

  • Investigator interest has been very strong and 4 of the 8 SURPASS clinical trials are already fully enrolled.

    研究人員的興趣非常強烈,8 項 SURPASS 臨床試驗中有 4 項已經完全註冊。

  • We look forward to sharing top line results for the first study to read out from the SURPASS program later this year.

    我們期待著分享今年晚些時候從 SURPASS 計劃中讀出的第一項研究的頂級結果。

  • Finally, we're excited that the SURMOUNT Phase III obesity program is actively dosing patients and that the SYNERGY Phase II program in NASH is currently underway as well.

    最後,我們很高興 SURMOUNT III 期肥胖計劃正在積極為患者給藥,並且 NASH 的 SYNERGY II 期計劃目前也正在進行中。

  • Given the profound weight loss seen in Phase II trials of tirzepatide, we're excited about the potential opportunity these additional clinical programs present to help patients.

    鑑於在 tirzepatide 的 II 期試驗中出現了顯著的體重減輕,我們對這些額外的臨床項目為幫助患者提供的潛在機會感到興奮。

  • Together with the ongoing SURPASS studies, these additional studies will expand the current Phase III tirzepatide program to over 20,000 patients.

    連同正在進行的 SURPASS 研究,這些額外的研究將把目前的 III 期 tirzepatide 計劃擴大到 20,000 多名患者。

  • We're excited about the breakthrough that tirzepatide represents for patients, and we'll continue to invest fully to maximize this opportunity.

    我們對 tirzepatide 為患者帶來的突破感到興奮,我們將繼續全力投資以最大限度地利用這一機會。

  • Moving to Slide 21.

    轉到幻燈片 21。

  • We recently announced the completion of the final 2 studies of the BREEZE-AD clinical program, BREEZE-AD4 and BREEZE-AD5.

    我們最近宣布完成了 BREEZE-AD 臨床計劃的最後兩項研究,即 BREEZE-AD4 和 BREEZE-AD5。

  • The full BREEZE program was comprised of 5 studies assessing baricitinib in both monotherapy and in combination with topical corticosteroids in patients with moderate to severe atopic dermatitis.

    完整的 BREEZE 計劃包括 5 項研究,評估巴瑞替尼在中度至重度特應性皮炎患者中的單藥治療和與局部皮質類固醇聯合治療。

  • While not all the data have yet been presented, we're particularly encouraged by the strong results for the 2-milligram dose in the U.S. trial.

    雖然尚未提供所有數據,但我們對美國試驗中 2 毫克劑量的強勁結果感到特別鼓舞。

  • We believe that the full data package generated from BREEZE-AD shows the potential that baricitinib could offer as an additional treatment option for patients with atopic dermatitis where there are limited choices.

    我們相信,從 BREEZE-AD 生成的完整數據包顯示了 baricitinib 可以作為選擇有限的特應性皮炎患者的額外治療選擇的潛力。

  • In addition, these data add to the large safety database of baricitinib, having over 10,000 patient years of safety data.

    此外,這些數據添加到巴瑞替尼的大型安全數據庫中,該數據庫擁有超過 10,000 個患者年的安全數據。

  • We recently submitted baricitinib for atopic dermatitis in the EU and Japan, and we expect regulatory action late in 2020.

    我們最近在歐盟和日本提交了用於治療特應性皮炎的巴瑞替尼,我們預計將在 2020 年末採取監管行動。

  • We plan to submit in the U.S. later this year.

    我們計劃在今年晚些時候在美國提交。

  • We anticipate that baricitinib will be the first oral JAK inhibitor for the treatment of atopic dermatitis, and we look forward to bringing a new treatment option to patients.

    我們預計巴瑞替尼將成為首個治療特應性皮炎的口服 JAK 抑製劑,期待為患者帶來新的治療選擇。

  • Finally, we recently announced the planned acquisition of Dermira.

    最後,我們最近宣布了收購 Dermira 的計劃。

  • Pending deal closing, this transaction would add an additional medicine to the Lilly pipeline for moderate to severe atopic dermatitis that is lebrikizumab, which is an injectable antibody targeting IL-13 currently in Phase III trials.

    在交易完成之前,該交易將為禮來公司的中度至重度特應性皮炎管道增加一種額外的藥物,即 lebrikizumab,這是一種目前處於 III 期試驗中的針對 IL-13的可注射抗體。

  • We view lebrikizumab as highly complementary to our efforts with baricitinib in atopic dermatitis.

    我們認為 lebrikizumab 與我們在特應性皮炎中使用 baricitinib 的努力高度互補。

  • The unmet medical need here is large, and we anticipate physicians and patients will use a range of oral injectable therapies, similar to current common practice for the treatment of psoriasis.

    這裡未滿足的醫療需求很大,我們預計醫生和患者將使用一系列口服注射療法,類似於目前治療銀屑病的常見做法。

  • Now I'll turn the call back over to Dave for some closing remarks.

    現在我將把電話轉回給戴夫做一些結束語。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Thank you, Dan.

    謝謝你,丹。

  • Before we go to Q&A, let me briefly sum up the progress we've made in the fourth quarter of 2019 and the full year.

    在進行問答之前,讓我簡要總結一下我們在 2019 年第四季度和全年取得的進展。

  • We delivered impressive performance in Q4.

    我們在第四季度的表現令人印象深刻。

  • Our revenue grew 8% as our newest medicines were again the catalyst for volume-based growth.

    我們的收入增長了 8%,因為我們的最新藥物再次成為基於銷量的增長的催化劑。

  • Our worldwide prescription trends are strong, and we are well positioned entering 2020 to continue our positive trajectory and deliver our 2020 financial guidance.

    我們的全球處方趨勢強勁,我們已準備好進入 2020 年,繼續我們的積極發展軌跡並提供 2020 年的財務指導。

  • We advanced our productivity agenda, controlling operating expenses while investing behind key commercial growth drivers and our late-stage pipeline.

    我們推進了生產力議程,控制了運營費用,同時投資於關鍵的商業增長驅動因素和我們的後期管道。

  • We grew sales in Q4 while keeping marketing, selling and administrative expenses flat versus Q4 '18, demonstrating our ability to drive margin expansion.

    我們在第四季度實現了銷售額增長,同時保持營銷、銷售和管理費用與 18 年第四季度持平,這證明了我們推動利潤增長的能力。

  • We made important pipeline progress in Q4, capping a year that featured significant new additions to the Phase III portfolio, several positive readouts in Phase III trials and a multitude of regulatory submissions and approvals.

    我們在第四季度取得了重要的管道進展,為第三階段產品組合的重要新成員、第三階段試驗中的幾個積極讀數以及大量監管提交和批准的一年畫上了句號。

  • Finally, we returned nearly $600 million to shareholders via the dividend and completed $300 million of share repurchases as well.

    最後,我們通過股息向股東返還了近 6 億美元,並完成了 3 億美元的股票回購。

  • As we shared during our 2020 financial guidance call last December, we are in the early stages of a period of sustained growth at Lilly.

    正如我們在去年 12 月的 2020 年財務指導電話會議上所分享的那樣,我們正處於禮來(Lilly)持續增長時期的早期階段。

  • The balance of new medicines we plan to launch over the next 5 years and the continued scaling of our newer medicines compared to our limited patent exposure sets up an exciting period ahead.

    與我們有限的專利風險相比,我們計劃在未來 5 年內推出的新藥的平衡以及我們新藥的持續擴展為未來創造了一個令人興奮的時期。

  • We are pursuing new medicines in some of the most important diseases with both significant unmet medical need and sizable business opportunities.

    我們正在為一些最重要的疾病尋求新藥,這些疾病既有重大的未滿足的醫療需求,也有巨大的商機。

  • We are pleased with our finish to 2019 and our position of strength as we enter 2020 and the next decade of this company's history.

    我們對 2019 年的結束以及進入 2020 年和公司歷史的下一個十年的實力地位感到滿意。

  • This concludes our prepared remarks.

    我們準備好的評論到此結束。

  • And now I'll turn the call over to Kevin to moderate the Q&A.

    現在我將把電話轉給 Kevin 來主持問答環節。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

  • (Operator Instructions)

    (操作員說明)

  • Sean, please provide the instructions for the Q&A session, and then we're ready for the first caller.

    肖恩,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) Our first question is going to come from the line of Geoff Meacham from Bank of America Merrill Lynch.

    (操作員說明)我們的第一個問題將來自美銀美林的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • I just had one on Taltz and one on the Olumiant filing in AD.

    我只有一個關於 Taltz 和一個關於 AD 中的 Olumiant 文件。

  • So for Taltz, the growth has been solid, but what would you say could be a demand tipping point looking to 2020 and beyond?

    所以對於 Taltz 來說,增長一直很穩固,但你認為什麼可能是 2020 年及以後的需求臨界點?

  • Is it new contracting agreements?

    是新的合同協議嗎?

  • Is it a broader indication base?

    它是更廣泛的適應症基礎嗎?

  • Do you have to invest more commercially?

    您是否需要進行更多商業投資?

  • And then on the Olumiant filing in AD, I wasn't sure if the effect of the 4 mg dose changes the regulatory conversation in the U.S. At the -- probably you've had in the RA indication since approval, obviously, was mostly focused on the 2 mg indication or the 2 mg approval, but I wasn't sure if that changes at all on the back of this new data.

    然後在 AD 中的 Olumiant 文件中,我不確定 4 毫克劑量的效果是否會改變美國的監管對話。在 - 很明顯,自從批准以來,你可能已經在 RA 適應症中獲得了主要關注關於 2 mg 適應症或 2 mg 批准,但我不確定在這個新數據的背後是否會發生變化。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Geoff.

    謝謝,傑夫。

  • We'll go to Patrik for both of those questions.

    我們將向 Patrik 提出這兩個問題。

  • Patrik Jonsson - Senior VP & President of Lilly Bio-Medicines

    Patrik Jonsson - Senior VP & President of Lilly Bio-Medicines

  • Well, thank you very much.

    好的,謝謝。

  • We are very pleased with the performance of Taltz in the fourth quarter last year with the growth of total Rx with approximately 40%.

    我們對 Taltz 去年第四季度的表現感到非常滿意,總 Rx 增長了約 40%。

  • If we look at the different spaces, first of all, dermatology, despite the increased competition, we think we are holding ground very nicely, and we are maintaining our total Rx share of market in Q4 despite the increased competition.

    如果我們看看不同的領域,首先是皮膚科,儘管競爭加劇,我們認為我們的表現非常好,儘管競爭加劇,我們在第四季度保持了我們的總 Rx 市場份額。

  • Also, added to the body of evidence, the head-to-head data versus Tremfya the IL-23 where we again demonstrated superiority on skin clearance.

    此外,添加到證據主體中,與 Tremfya IL-23 的頭對頭數據,我們再次證明了在皮膚清除方面的優勢。

  • And that's the third study combined with Stelara and in Enbrel where we have again demonstrated superiority.

    這是與 Stelara 和 Enbrel 相結合的第三項研究,我們再次證明了其優越性。

  • So we are confident in continued growth in the space of dermatology.

    因此,我們對皮膚病學領域的持續增長充滿信心。

  • The biggest opportunity for us remains being in rheumatology where we, in Q4, announced the only IL-17 to demonstrate superiority versus HUMIRA in the SPIRIT head-to-head study.

    對我們來說,最大的機會仍然是風濕病學,我們在第四季度宣布了唯一的 IL-17,在 SPIRIT 頭對頭研究中顯示出優於 HUMIRA 的優勢。

  • And we saw some significant acceleration in Q4 in terms of new-to-brand, and we are confident that we will continue to grow in the rheumatology space where there are a lot of opportunities for us.

    我們在新品牌方面看到了第四季度的顯著加速,我們有信心在風濕病領域繼續增長,這對我們來說有很多機會。

  • We also filed during the second half of the last year the non-radiographic axSpA, and that's an indication where we also see a lot of patients that are not being appropriately diagnosed and even if diagnosed, not appropriately treated.

    我們還在去年下半年提交了非射線照相 axSpA,這表明我們還看到很多患者沒有得到適當的診斷,即使被診斷出來,也沒有得到適當的治療。

  • Lastly, both in dermatology and rheumatology, a huge amount of patients are still treated with anti-TNF alphas.

    最後,在皮膚病學和風濕病學領域,仍有大量患者接受抗 TNF α 治療。

  • In dermatology, 40%; and in rheumatology, 70%.

    在皮膚科,40%;在風濕病學中,70%。

  • And we believe that, that remains the biggest opportunity for all new assets to ensure that patients are being upgraded to new modern more efficacious and safer treatments.

    我們相信,這仍然是所有新資產的最大機會,可確保患者升級到新的現代更有效和更安全的治療方法。

  • In terms of Olumiant, while we don't comment on regulatory actions for specific brands, we continue to explore options to get the 4-milligram dose get approved in the U.S. However, in the light of most recent regulatory actions with other JAK inhibitors, we're also realistic in terms of our expectations to get 4-milligram approved in the U.S. in the near term.

    在 Olumiant 方面,雖然我們不對特定品牌的監管行動發表評論,但我們繼續探索使 4 毫克劑量在美國獲得批准的選擇。然而,鑑於最近對其他 JAK 抑製劑的監管行動,我們對短期內在美國獲得 4 毫克批准的期望也是現實的。

  • But as Dave mentioned, we are very much encouraged by the 2-milligram data of Olumiant in atopic dermatitis and where we're demonstrating hitting our primary objective both in terms of at least 75% improvement on skin inflammation, but also in terms of patient-reported outcomes, improvement on itching.

    但正如 Dave 提到的,我們對 Olumiant 在特應性皮炎中的 2 毫克數據感到非常鼓舞,並且我們證明了我們的主要目標是在皮膚炎症改善至少 75% 方面,以及在患者方面- 報告結果,瘙癢改善。

  • So that is encouraging for us in terms of the Olumiant submission in the U.S.

    因此,就美國的 Olumiant 提交而言,這對我們來說是令人鼓舞的。

  • Operator

    Operator

  • Next question is going to come from the line of Chris Schott from JPMorgan.

    下一個問題將來自摩根大通的 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • First question was just on the quarterly progression of sales and earnings as we go through 2020.

    第一個問題只是關於我們到 2020 年的銷售和收益的季度進展。

  • I think last year, we saw a depressed first quarter sales relative to the rest of the year that surprised The Street a bit.

    我認為去年,我們看到第一季度的銷售額相對於今年剩餘時間的低迷,這讓 The Street 有點吃驚。

  • Should we expect a similar gating of sales in 2020?

    我們是否應該期待 2020 年出現類似的銷售限制?

  • And are there any particular products we should be watching where, I guess, 2020 kind of resets of plans could impact those first quarter results?

    我們應該關注哪些特定產品,我猜,2020 年的計劃重置可能會影響第一季度的業績?

  • My second question was just on the Alzheimer's strategy more broadly.

    我的第二個問題是關於更廣泛的阿爾茨海默氏症策略。

  • How would the approval or I guess not of aducanumab impact how you're thinking about your pending Alzheimer's readouts and development strategies from here?

    批准或我猜不批准 aducanumab 將如何影響您從這裡考慮待定的阿爾茨海默氏症讀數和發展戰略?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Chris.

    謝謝,克里斯。

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

    第一個問題我們去找 Josh,第二個問題找 Dan。

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Thanks, Chris.

    謝謝,克里斯。

  • I -- If we look at 2020, we don't provide quarterly guidance.

    我——如果我們看 2020 年,我們不提供季度指導。

  • But if we look at sort of the trajectory of sales that we'd expect, if you look at our guidance for the full year, we're in somewhere in the high single digits for sales growth.

    但是,如果我們看看我們預期的銷售軌跡,如果你看看我們全年的指導,我們的銷售增長處於高個位數。

  • We'd expect that, that kind of growth to be pretty consistent through the year although keep in mind, in Q1, we still will have a little bit more of the overhang from things like Cialis.

    我們預計,這種增長將在全年保持一致,儘管請記住,在第一季度,我們仍然會受到 Cialis 等產品的更多影響。

  • So you might expect to see a little bit more sales growth through the year, but pretty consistent.

    因此,您可能希望看到全年銷售增長更多,但相當一致。

  • On an absolute basis, though, Chris, we do always see sales in Q1 lower than Q4.

    不過,克里斯,在絕對基礎上,我們確實總是看到第一季度的銷售額低於第四季度。

  • A lot of that just has to do with shipping patterns and otherwise.

    其中很多只是與運輸模式等有關。

  • So again, growth should look good in Q1 relative to the year.

    因此,與今年相比,第一季度的增長應該看起來不錯。

  • Absolute sales will be less.

    絕對銷量會更少。

  • I think that's a trend that you see, I'm sure, across almost all companies.

    我認為這是你看到的趨勢,我敢肯定,幾乎所有公司都有。

  • There's nothing unique going on there other than normal shipping patterns between Q4 and Q1.

    除了第四季度和第一季度之間的正常運輸模式外,沒有什麼獨特之處。

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Chris, thanks for your question on Alzheimer's strategy.

    克里斯,感謝您對阿爾茨海默氏症策略的提問。

  • Of course, we, like many others, will be watching aducanumab closely.

    當然,我們和許多其他人一樣,將密切關注 aducanumab。

  • And of course, we'll adapt our plans and thinking to meet wherever we see the regulatory bar placed.

    當然,我們會調整我們的計劃和思維,以滿足我們看到監管欄設置的任何地方。

  • But I don't think you should expect us to pivot in our Alzheimer's strategy one way or another.

    但我認為你不應該期望我們以一種或另一種方式調整我們的阿爾茨海默氏症策略。

  • We've placed some pretty important bets.

    我們已經下了一些非常重要的賭注。

  • We're excited to see those readouts over time both with solanezumab, but also our own plaque-clearing antibody, donanemab, as well as our tau -- anti-tau antibody that's in Phase II.

    我們很高興看到隨著時間的推移使用 solanezumab 以及我們自己的斑塊清除抗體 donanemab 以及處於 II 期的 tau 抗 tau 抗體的這些讀數。

  • We also have a tau small molecule in Phase I and other agents earlier in development.

    我們還有一個處於 I 期的 tau 小分子和其他處於早期開發階段的藥物。

  • So we'll continue to progress those.

    所以我們將繼續推進這些。

  • We think we have smartly designed trials that will give us important readouts over time.

    我們認為我們精心設計了試驗,這些試驗將隨著時間的推移為我們提供重要的讀數。

  • Operator

    Operator

  • Our next question is going to come from Louise Chen from Cantor.

    我們的下一個問題將來自 Cantor 的 Louise Chen。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So first question I had for you is can you provide more color on what might be driving your stronger volume growth when compared to other companies out there in the space and if this is durable over the longer term?

    因此,我向您提出的第一個問題是,與該領域的其他公司相比,您能否就可能推動您更強勁的銷量增長的因素提供更多色彩,以及這是否能長期持久?

  • And then my second question for you is with this growing competition in atopic dermatitis, where do you see Lilly fitting into the evolving treatment paradigm?

    然後我要問您的第二個問題是,隨著特應性皮炎領域的競爭日益激烈,您認為禮來公司在哪些方面適合不斷發展的治療模式?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thank you.

    謝謝你。

  • So we'll go to Josh for the first question and Patrik for the second.

    所以我們將請喬希回答第一個問題,帕特里克回答第二個問題。

  • Thanks, Josh.

    謝謝,喬希。

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Thanks, Louise.

    謝謝,路易絲。

  • I think in terms of volume growth, what we see at a corporate level is a function of our portfolio.

    我認為就銷量增長而言,我們在公司層面看到的是我們投資組合的函數。

  • As we mentioned, about a little bit less than half of our sales are coming from new products that we've launched since 2014, 10 of those.

    正如我們所提到的,我們的銷售額中約有不到一半來自我們自 2014 年以來推出的新產品,其中有 10 種。

  • They are all still in -- very much in their growth phases: Trulicity growing at 31%, for example; Taltz at 37%.

    它們都還處於——非常處於增長階段:例如,Trulicity 增長了 31%;塔爾茲為 37%。

  • So we've got a relatively young portfolio.

    所以我們有一個相對年輕的投資組合。

  • We expect the volume gains that we saw in Q4 to be sustainable between 2020 and 2025.

    我們預計,我們在第四季度看到的銷量增長將在 2020 年至 2025 年之間持續。

  • As we mentioned on our guidance call, we expect to see top-tier revenue growth over that period.

    正如我們在指導電話中提到的那樣,我們預計在此期間會看到頂級收入增長。

  • And it will be driven by volume gains.

    它將受到銷量增長的推動。

  • It will be driven by that cohort of products as well as the new launches that we'll expect over this period, including the 3 that we're planning for this year.

    這將受到該系列產品以及我們預計在此期間推出的新產品的推動,包括我們今年計劃推出的 3 款產品。

  • You couple that going forward with less generic exposure than probably most of the companies that we compete against or that you cover, and I think that would certainly say to us that the volume gains we're seeing are something that we're planning for and think are sustainable.

    與我們競爭或您所覆蓋的大多數公司相比,您將這與未來的通用曝光率相結合,我認為這肯定會告訴我們,我們看到的銷量增長是我們正在計劃的事情,並且認為是可持續的。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • Patrik?

    帕特里克?

  • Patrik Jonsson - Senior VP & President of Lilly Bio-Medicines

    Patrik Jonsson - Senior VP & President of Lilly Bio-Medicines

  • Well, currently, it's estimated that approximately 18 million Americans are suffering from atopic dermatitis, and 10 million of those are suffering from severe to moderate atopic dermatitis.

    那麼,目前,估計大約有 1800 萬美國人患有特應性皮炎,其中 1000 萬人患有重度至中度特應性皮炎。

  • And the treatment opportunities are very limited.

    而且治療機會非常有限。

  • One is saying is that the field of atopic dermatitis is pretty much where psoriasis was 15 years ago.

    有人說,特應性皮炎領域與 15 年前的牛皮癬差不多。

  • And in the light of that, we believe that we are extremely well positioned.

    鑑於此,我們相信我們處於非常有利的位置。

  • As we shared, we are encouraged with the most recent data on Olumiant both in the U.S. and outside the U.S. And we have submitted Olumiant for approval in Japan and EU, and we take regulatory actions in 2020 here in the U.S. And we believe that Olumiant could definitely be an option for patients that are having fear of injection.

    正如我們所分享的,我們對 Olumiant 在美國和美國以外的最新數據感到鼓舞。我們已將 Olumiant 提交日本和歐盟批准,我們將在 2020 年在美國採取監管行動。我們相信 Olumiant對於害怕注射的患者來說,這絕對是一種選擇。

  • And we are also excited about the announcement we made a few weeks ago about our intent and aim to acquire Dermira.

    我們也對幾週前宣布的關於我們收購 Dermira 的意圖和目標感到興奮。

  • And lebrikizumab is the big driver of that deal.

    lebrikizumab 是這筆交易的主要推動力。

  • And we see lebrikizumab, based upon the Phase IIb data, as a medicine that will at least be competitive with DUPIXENT and with an opportunity to even be best-in-class differentiating on itch.

    根據 IIb 期數據,我們將 lebrikizumab 視為一種藥物,至少可以與 DUPIXENT 競爭,甚至有機會成為一流的瘙癢差異化藥物。

  • So overall, we believe that we can play a very important role in the field of atopic dermatitis with both the first oral JAK inhibitor for patients who have fear of injection and a potential best-in-class medicine in lebrikizumab.

    因此,總體而言,我們相信我們可以在特應性皮炎領域發揮非常重要的作用,這既是針對害怕注射的患者的第一個口服 JAK 抑製劑,也是潛在的同類最佳藥物 lebrikizumab。

  • Operator

    Operator

  • Our next question will come from the line of Tim Anderson from Wolfe Research.

    我們的下一個問題將來自 Wolfe Research 的 Tim Anderson。

  • I apologize.

    我道歉。

  • Our next question, it will come from the line of Umer Raffat from Evercore ISI.

    我們的下一個問題將來自 Evercore ISI 的 Umer Raffat。

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

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • Thanks so much for taking my two questions, both of them are Kevin's favorite topic.

    非常感謝您提出我的兩個問題,這兩個問題都是凱文最喜歡的話題。

  • So the first one is on CNS penetrants of your GLP-1, and I have 2 parts on this first one.

    所以第一個是關於你的 GLP-1 的 CNS 滲透劑,我有兩個關於第一個的部分。

  • So there's feedback out there that Trulicity doesn't cross blood-brain barrier very much, perhaps in part because of its size.

    因此,有反饋表明,Trulicity 並不會過多地穿過血腦屏障,部分原因可能是它的大小。

  • A, can you comment on that?

    A,你能評論一下嗎?

  • And in that same question, I also want to ask tirzepatide does not have an IGG.

    在同一個問題中,我還想問一下 tirzepatide 沒有 IGG。

  • So presumably, it should have good CNS penetration.

    所以推測它應該具有良好的中樞神經系統滲透。

  • I just want to make sure I hear your take on the CNS penetrants of both Trulicity and tirzepatide.

    我只是想確保我聽到你對 Trulicity 和 tirzepatide 的 CNS 滲透劑的看法。

  • Secondly, Dave, perhaps for you.

    其次,戴夫,也許是為了你。

  • So the A4 trial in asymptomatic Alzheimer's, my understanding is it was fully enrolled in December 2017.

    因此,無症狀阿爾茨海默氏症的 A4 試驗,我的理解是,它於 2017 年 12 月全面入組。

  • And at this point, it's already past 2 years in every single patient.

    在這一點上,每個患者都已經過去了 2 年。

  • And by end of 2020, you would have hit a 3-year landmark in every single patient.

    到 2020 年底,您將在每位患者身上達到 3 年的里程碑。

  • So my question is strategically thinking, if regulators are being more accommodating of late, wouldn't it make strategic sense to possibly consider taking an efficacy read at 3 years?

    所以我的問題是從戰略上思考,如果監管機構最近變得更加通融,那麼考慮在 3 年時讀取功效是否具有戰略意義?

  • Because even at 3 years, it's 2x the duration of all prior sola and aducanumab trials.

    因為即使是 3 年,它也是之前所有 sola 和 aducanumab 試驗持續時間的 2 倍。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Umer, for those questions.

    謝謝,Umer,這些問題。

  • This is -- Butler Bulldog basketball is probably my favorite topic, but we don't cover that on the call.

    這是——巴特勒鬥牛犬籃球可能是我最喜歡的話題,但我們不會在電話會議上討論這個話題。

  • This is a close second, though.

    不過,這是緊隨其後的。

  • We'll go to Dan for both of these.

    我們會去丹為這兩個。

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Okay.

    好的。

  • Great.

    偉大的。

  • Thanks so much.

    非常感謝。

  • So with respect to CNS penetration of GLP-1s, you're right that these are large molecularly molecules.

    所以關於 GLP-1 的 CNS 滲透,你說得對,這些是大分子分子。

  • Actually, both the Fc-fusion molecules like Trulicity and also, acylated peptides like tirzepatide.

    實際上,像 Trulicity 這樣的 Fc 融合分子和像 tirzepatide 這樣的酰化肽。

  • Those modifications of the peptides are what gives them the long half-life that enables once-weekly injection.

    肽的這些修飾使它們具有較長的半衰期,可以每週注射一次。

  • And molecules of that size typically don't penetrate the blood-brain barrier.

    這種大小的分子通常不會穿透血腦屏障。

  • Having said that, we don't see those attributes, blood-brain barrier penetration, as being important for the efficacy of this class of drugs as evidenced I think by the tremendous efficacy that we've seen with Trulicity and an unprecedented efficacy that we've seen with tirzepatide.

    話雖如此,我們並不認為血腦屏障滲透這些屬性對這類藥物的功效很重要,我認為我們在 Trulicity 中看到的巨大功效和我們前所未有的功效就證明了這一點'用替西帕肽見過。

  • So I think that addresses that.

    所以我認為這解決了這個問題。

  • With respect to A4, you're right that this is longer duration trial than, really, I think, any other large Alzheimer's trial has ever been.

    關於 A4,你是對的,這是比我認為的任何其他大型阿爾茨海默氏症試驗更長的試驗時間。

  • The reason for that though is because these patients are asymptomatic at the beginning of the trial.

    這樣做的原因是因為這些患者在試驗開始時沒有症狀。

  • So they're very early in the disease course.

    所以他們處於疾病進程的早期。

  • And it takes a great deal of time to let these patients progress in their disease course.

    讓這些患者在疾病過程中取得進展需要大量時間。

  • And it's only through progression of patients on the placebo group and hopefully differential less progression of patients on therapy that we could hope to see effective drug.

    只有通過安慰劑組患者的進展,並希望在治療中區分較少進展的患者,我們才能希望看到有效的藥物。

  • So that's why the design includes such a long follow-up period.

    所以這就是為什麼設計包括如此長的跟進期。

  • Operator

    Operator

  • And once again, we're going to have a question from the line of Tim Anderson from Wolfe Research.

    再一次,我們將有一個來自 Wolfe Research 的 Tim Anderson 的問題。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • A question on your PD-1 with Innovent and really plans for that product outside the U.S. It seemed like last summer, when I talked to management, it was really described as a China-only opportunity with limited potential.

    關於您與 Innovent 的 PD-1 的問題以及該產品在美國以外的真正計劃。似乎去年夏天,當我與管理層交談時,它確實被描述為僅限中國的機會,潛力有限。

  • But it seems that you may have pivoted in recent months and may have bigger plans to bring them into other geographies.

    但似乎您最近幾個月可能已經轉向,並且可能有更大的計劃將它們帶入其他地區。

  • So I'm hoping you can give us your latest thinking.

    所以我希望你能給我們你的最新想法。

  • And then second question is just on the DIAN-TU Alzheimer's trial.

    然後第二個問題是關於 DIAN-TU 阿爾茨海默氏症的試驗。

  • Confirming that we should see those results really any time, can you confirm that?

    確認我們應該隨時看到這些結果,你能確認嗎?

  • And then just how do you view odds of success?

    然後你如何看待成功的機率?

  • It kind of seems to me that it's highly improbable that this will yield positive results for sola, but what are your views?

    在我看來,這對 sola 產生積極影響的可能性很小,但您的看法是什麼?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Tim.

    謝謝,蒂姆。

  • We'll go to Anne for the first question and Dan for the second.

    第一個問題我們去找安妮,第二個問題找丹。

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

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

  • Well, Tim, thanks for the question on Tyvyt and our Innovent collaboration.

    好吧,蒂姆,感謝關於 Tyvyt 和我們的 Innovent 合作的問題。

  • So as you said, our current focus is on development and commercialization of Tyvyt in China.

    正如您所說,我們目前的重點是 Tyvyt 在中國的開發和商業化。

  • However, Innovent's been really important and a terrific strategic partner to us, and so we're always open to discussing opportunities to expand that for mutual benefit.

    然而,Innovent 對我們來說非常重要,也是一個了不起的戰略合作夥伴,因此我們總是樂於討論擴大合作夥伴關係以實現互惠互利的機會。

  • There's really not more we can say at this time.

    目前我們真的無話可說。

  • We're really pleased, I think as Josh and Dave mentioned, with the performance of Tyvyt in China.

    正如 Josh 和 Dave 所說,我們真的很高興 Tyvyt 在中國的表現。

  • It's been a remarkable story, and really now, as you know, the only PD-1 that's included on the NRDL list, and I think that demonstrates how the NHSA has recognized its clinical value.

    這是一個了不起的故事,正如你所知,現在是唯一一個被列入 NRDL 名單的 PD-1,我認為這表明 NHSA 如何認識到其臨床價值。

  • And then we were able to share the great news that we have the first-line nonsquamous readout at interim.

    然後我們能夠分享一個好消息,即我們在過渡期間擁有一線非鱗狀細胞讀數。

  • It's positive.

    這是積極的。

  • So we'll be planning to submit that this year and that we expect additional readouts in first and second line squamous this year with Innovent.

    因此,我們計劃今年提交該文件,並且我們預計今年 Innovent 會在一線和二線鱗狀細胞中獲得更多讀數。

  • So it's been a great product, and we look forward to what more we can do here, but thanks for the question.

    所以這是一個很棒的產品,我們期待著我們可以在這裡做更多的事情,但是感謝這個問題。

  • 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

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Yes.

    是的。

  • Tim, on DIAN, just a reminder for everyone that this is a dominantly inherited type of Alzheimer's.

    Tim,關於 DIAN,只是提醒大家這是一種顯性遺傳的阿爾茨海默氏症。

  • It's a rare and sort of severe and fast-progressing form of Alzheimer's disease where we're testing solanezumab.

    這是一種罕見的、嚴重且進展迅速的阿爾茨海默病形式,我們正在測試 solanezumab。

  • Your question on timing of results, we don't have the data yet, but we do expect that this quarter.

    您關於結果時間的問題,我們還沒有數據,但我們確實預計本季度會有數據。

  • In terms of the odds to success, I think it's hard to speculate.

    就成功的機率而言,我認為很難推測。

  • But as you know, this is a very small trial.

    但如你所知,這是一個非常小的試驗。

  • A small population is being studied.

    正在研究一小部分人群。

  • And it is, as I said, a severe form of Alzheimer's.

    正如我所說,它是一種嚴重的阿爾茨海默氏症。

  • So those factors weigh against it.

    因此,這些因素對其不利。

  • There's other factors that weigh for it.

    還有其他因素影響它。

  • We know that it's driven by mutations here in amyloid overproduction and has a relatively longer follow-up.

    我們知道它是由澱粉樣蛋白過度產生的突變驅動的,並且隨訪時間相對較長。

  • But we'll just have to wait and see data.

    但我們只需要等著看數據。

  • Operator

    Operator

  • Our next question is going to come from the line of Andrew Baum from Citi.

    我們的下一個問題將來自花旗的 Andrew Baum。

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

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • A couple of questions.

    幾個問題。

  • Firstly, in relation to tirzepatide, you highlighted the planned (inaudible).

    首先,關於 tirzepatide,您強調了計劃(聽不清)。

  • There's been some literature where the patent is that it may not be (inaudible)

    有一些文獻表明專利可能不是(聽不清)

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Andrew, this is Kevin.

    安德魯,這是凱文。

  • We're -- Andrew, we're really having trouble hearing you and can't really pick up the question other than we heard tirzepatide.

    我們 - 安德魯,我們真的很難聽到你的聲音,除了聽到 tirzepatide 之外,我們真的無法回答這個問題。

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

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • Is that any better?

    這樣更好嗎?

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • No.

    不。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Not much.

    不多。

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

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • Can you hear me?

    你能聽到我嗎?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Yes.

    是的。

  • We'll try it.

    我們會試試看。

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

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • So my question is on tirzepatide.

    所以我的問題是關於替西帕肽。

  • Talking about the cardiovascular OUTCOME trial, you're running a head-to-head trial versus Ozempic, which has been described as a high bar.

    談到心血管 OUTCOME 試驗,您正在與 Ozempic 進行面對面的試驗,這被描述為一個高標準。

  • There is some literature on potentially GL -- GIP agonism.

    有一些關於潛在 GL - GIP 激動的文獻。

  • If agonism could potentially be increasing cardiovascular rather than decreasing risk, given its evidence as a marker of heightened cardiovascular disease as well as some preclinical data.

    如果激動可能會增加心血管疾病而不是降低風險,考慮到它作為心血管疾病升高的標誌物的證據以及一些臨床前數據。

  • Perhaps you could talk to your thoughts on the relevance of that literature.

    也許你可以談談你對那篇文獻的相關性的看法。

  • And then second, more broadly, we like to think that Lilly is perhaps a better place than many of your peers in understanding the direction of this particular administration in terms of health care reform.

    其次,更廣泛地說,我們認為禮來可能比您的許多同行更好地了解這個特定政府在醫療改革方面的方向。

  • There have been some discussions about whether the IPI proposal could be expanded to include Medicare Part D drugs rather than just the part B. Perhaps you could share your thoughts on what you expect in that direction.

    關於 IPI 提案是否可以擴大到包括 Medicare D 部分藥物而不僅僅是 B 部分的問題已經進行了一些討論。也許您可以分享您對這個方向的期望的想法。

  • Apologies for the line quality.

    為線路質量道歉。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Okay.

    好的。

  • Thanks, Andrew.

    謝謝,安德魯。

  • We'll go to Dan for the question on tirzepatide and then Dave on the policy question.

    我們將向 Dan 詢問有關 tirzepatide 的問題,然後向 Dave 詢問政策問題。

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Yes.

    是的。

  • Thanks.

    謝謝。

  • First of all, just a clarification, the tirzepatide trial is head-to-head against Trulicity.

    首先,澄清一下,tirzepatide 試驗與 Trulicity 正面交鋒。

  • Look, I think that there is a little bit of literature out there, as you referenced, about the effects of GIP-1.

    看,我認為有一些文獻,正如你所引用的,關於 GIP-1 的影響。

  • But our thinking is really based on the clinical data that we've already obtained with tirzepatide in the Phase II trials.

    但我們的想法實際上是基於我們已經在 II 期試驗中使用 tirzepatide 獲得的臨床數據。

  • I think everything we see in those trials point to a large cardiovascular benefit for a drug like this.

    我認為我們在這些試驗中看到的一切都表明這種藥物對心血管有很大的好處。

  • And so that's the driver.

    這就是驅動程序。

  • That's what gives us confidence is the real clinical data with this molecule.

    這就是讓我們有信心的是這種分子的真實臨床數據。

  • The combination of GLP-1 and GIP 1 gives certain effects, which we were able to see.

    GLP-1 和 GIP 1 的組合產生了我們能夠看到的某些效果。

  • So for example, the improved A1c control and notably, the very dramatic improvement on weight loss, which I think will drive cardiovascular benefits even higher than we saw in Trulicity.

    因此,例如,改善 A1c 控制,尤其是體重減輕方面的顯著改善,我認為這將推動心血管益處,甚至比我們在 Trulicity 中看到的還要高。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • Dave?

    戴夫?

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Yes.

    是的。

  • So on the policy front, we continue to advocate for a change in the U.S. system because although we're in a, as an industry and certainly as Lilly, deflationary price environment, those savings are not reaching consumers at the pharmacy counter.

    因此,在政策方面,我們繼續倡導改變美國的體系,因為儘管我們處於一個行業,當然還有禮來公司的通貨緊縮的價格環境中,但這些儲蓄並沒有惠及藥房櫃檯的消費者。

  • And so either through a combination of passing through or transparency of those discounts or insurance reform, we're for change.

    因此,無論是通過這些折扣或保險改革的傳遞或透明度的組合,我們都支持改變。

  • And our focus is primarily right now with the legislative pathway on both those fronts.

    我們現在的重點主要是這兩個方面的立法途徑。

  • There's one more vehicle probably left in this Congress to work on those, but progress is difficult in Congress.

    本屆國會可能還有一輛車可以解決這些問題,但國會很難取得進展。

  • So we continue to advocate for change on behalf of patients, though.

    因此,我們繼續代表患者倡導變革。

  • As it relates to IPI, this proposal was part of the blueprint in spring of '18.

    由於它與 IPI 相關,因此該提案是 18 年春季藍圖的一部分。

  • It's been sitting out there for a while.

    它已經在外面坐了一段時間了。

  • We've yet to see any draft guidance for proposed rule-making or any version of this in detail.

    我們尚未看到任何有關擬議規則制定的指南草案或任何詳細版本。

  • There's always a lot of swirling rumors about it, including expanding it to other parts of the government programs or changes to it in terms of the objectives.

    總是有很多關於它的謠言,包括將其擴展到政府計劃的其他部分或在目標方面對其進行更改。

  • We see it largely as misguided primarily because in Part B, patients hardly have any cost-sharing to begin with.

    我們認為它在很大程度上被誤導了,主要是因為在 B 部分中,患者幾乎沒有任何費用分攤開始。

  • So if we're worried about out-of-pocket costs for patients, IPI will do very little.

    因此,如果我們擔心患者的自付費用,IPI 將無能為力。

  • It's mostly just a punitive measure against the industry.

    這主要是對行業的懲罰措施。

  • Going back to decisions made on European pricing sometimes decades ago, it won't probably change those prices in Europe, if that's the president's goal.

    回到幾十年前有時關於歐洲定價的決定,如果這是總統的目標,它可能不會改變歐洲的這些價格。

  • And it certainly won't change the affordability equation for patients in the U.S. So we oppose it for those reasons.

    而且它肯定不會改變美國患者的負擔能力等式,因此我們出於這些原因反對它。

  • That said, it's an administrative potential action, and we'll have to read it if it comes out and decide what to do from there.

    也就是說,這是一項潛在的行政行動,如果它出來,我們將不得不閱讀並決定從那裡做什麼。

  • But it pretty much is a difficult thing to support for our industry, and you probably see pharma universally opposed it.

    但要支持我們的行業幾乎是一件困難的事情,你可能會看到製藥公司普遍反對它。

  • So we'll wait and see.

    所以我們拭目以待。

  • Operator

    Operator

  • Our next question will come from the line of Seamus Fernandez from Guggenheim.

    我們的下一個問題將來自古根海姆的 Seamus Fernandez。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • So maybe the first question is really for Josh.

    所以也許第一個問題真的是給喬希的。

  • Josh, can you just help us understand the progression of margins as we move through the balance of next year -- or sorry, this year in 2020?

    喬希,你能不能幫助我們了解明年餘下的利潤增長情況——或者對不起,今年是 2020 年?

  • When I look at the original guidance from this year, I think you guys had said 28% was the target.

    當我查看今年的原始指導時,我想你們說過 28% 是目標。

  • I think, ultimately, we ended up at 27.2% at the final point of the year.

    我認為,最終,我們在今年的最後一點最終達到了 27.2%。

  • But on the guidance call in December, you had -- you stated and reiterated the 31% target.

    但在 12 月的指導電話會議上,你已經 - 你陳述並重申了 31% 的目標。

  • Can you just help us understand the path to that 31%?

    你能幫助我們了解通往那 31% 的道路嗎?

  • Just because the second half of this year I think kind of came in below investors' expectations to some degree and we're just trying to understand a little bit better the very strong move in margins going higher.

    僅僅因為今年下半年,我認為在某種程度上低於投資者的預期,我們只是想更好地理解利潤率上升的強勁趨勢。

  • Obviously, the pieces of guidance makes sense.

    顯然,這些指導是有道理的。

  • I think we're just trying to understand the path as we move through the balance of the year.

    我認為我們只是想在今年餘下的時間裡了解這條路。

  • And then the second question, the pegilodecakin update, thanks for that, appreciate the understanding and the challenges.

    然後是第二個問題,pegilodecakin 更新,感謝您的理解和挑戰。

  • Can -- maybe Jake can just sort of update us on his thoughts.

    可以——也許傑克可以告訴我們他的想法。

  • And also, Dan, could update us on your thoughts for the growth of the oncology development portfolio and directionally where you're headed?

    此外,Dan,能否向我們介紹您對腫瘤學開發組合增長的想法以及您的發展方向?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Seamus.

    謝謝,西莫。

  • Well, Josh and then Dan.

    好吧,喬希,然後是丹。

  • Joshua L. Smiley - Senior VP & CFO

    Joshua L. Smiley - Senior VP & CFO

  • Great.

    偉大的。

  • Thanks, Seamus.

    謝謝,西莫。

  • In terms of margin this year, again, we've reiterated that we're on track for 31%.

    就今年的利潤率而言,我們再次重申,我們有望達到 31%。

  • And the one thing we have said is Q1 will likely be below 31%.

    我們說過的一件事是第一季度可能會低於 31%。

  • That's mostly a function of the less absolute sales that I talked about on a prior question on top of a relatively fixed OpEx absolute amount.

    這主要是我在前一個問題中談到的相對固定的運營支出絕對金額之上的不太絕對銷售額的函數。

  • So I think as you look or model OpEx for the year, we see that as pretty constant.

    因此,我認為當您查看或模擬本年度的運營支出時,我們認為這是相當穩定的。

  • On an absolute basis quarter-over-quarter, of course, some small variation.

    當然,在絕對的季度環比基礎上,會有一些小的變化。

  • And then you'll see absolute sales dollars on a quarter-over-quarter basis grow.

    然後你會看到絕對銷售額環比增長。

  • So we don't expect to be at 31% in Q1, but that's -- again, that's a function of the dynamics of the growth through the quarters.

    因此,我們預計第一季度不會達到 31%,但這是 - 再次,這是各個季度增長動態的函數。

  • Remember, though, in terms of how to get there in totals for the year, we said for 2019 that we would grow our R&D at an unusual growth rate in 2019 as we scale up programs like tirzepatide and mirikizumab.

    不過請記住,就全年如何實現這一目標而言,我們曾表示,隨著 tirzepatide 和 mirikizumab 等項目的擴大,我們將在 2019 年以不尋常的增長率增長我們的研發。

  • In 2020, those programs are running at more like full speed.

    在 2020 年,這些程序更像是全速運行。

  • We're able to bring in an asset like Dermira and keep that with a relatively smaller growth rate in R&D.

    我們能夠引入像 Dermira 這樣的資產,並以相對較小的研發增長率保持這種資產。

  • So I think we're confident that the sales growth that we're seeing, that we talked about in Q4 in our -- should persist for the year on top of a slower growing OpEx that we can predict and manage will get us to 31%.

    因此,我認為我們有信心,我們在第四季度談到的銷售增長應該會持續一年,而我們可以預測和管理的運營支出增長放緩將使我們達到 31 %。

  • And again, I wouldn't be too concerned in Q1 if we're not at that level, but you should expect it as we move through the year.

    再說一次,如果我們沒有達到那個水平,我不會在第一季度太擔心,但是隨著我們這一年的發展,你應該期待它。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Josh.

    謝謝,喬希。

  • Dan?

    擔?

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Yes.

    是的。

  • Thanks for the question on our oncology strategy.

    感謝您提出關於我們腫瘤學策略的問題。

  • Of course, on the last call, we talked about our Loxo Oncology at Lilly and how that's changed our oncology strategy.

    當然,在最後一次電話會議上,我們談到了禮來公司的 Loxo 腫瘤學,以及這如何改變了我們的腫瘤學戰略。

  • And we're quite pleased with the progress that we made on executing against that strategy.

    我們對我們在執行該戰略方面取得的進展感到非常滿意。

  • You can see some portfolio changes in our pipeline update.

    您可以在我們的管道更新中看到一些投資組合變化。

  • And we also talked about the 3 key early-stage programs, 305, KRAS and SERD, all of which are progressing in the clinic.

    我們還談到了3個關鍵的早期項目,305、KRAS和SERD,所有這些項目都在臨床上取得進展。

  • While we said we're going to focus a lot of our resources on high probability sort of biology, that's well understood.

    雖然我們說我們將把大量資源集中在高概率的生物學上,但這是很好理解的。

  • Bets like those, we will also from time to time continue to pursue more novel biology, higher risk, high-reward bets like pegilodecakin was.

    像這樣的賭注,我們也會不時地繼續追求更新穎的生物學、更高風險、高回報的賭注,比如 pegilodecakin。

  • And that will be a smaller part of our portfolio in the future.

    這將是我們未來投資組合的一小部分。

  • Operator

    Operator

  • Our next question comes from the line of David Risinger from Morgan Stanley.

    我們的下一個問題來自摩根士丹利的 David Risinger。

  • David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst

    David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst

  • I have two questions.

    我有兩個問題。

  • First, just going back to the high level on GLP-1s and Alzheimer's.

    首先,回到 GLP-1 和阿爾茨海默病的高水平。

  • Novo has recently conveyed enthusiasm about the potential for GLP-1 treatment in Alzheimer's.

    Novo 最近表達了對 GLP-1 治療阿爾茨海默病的潛力的熱情。

  • Could you just comment on your view of whether GLP-1 treatment over a few years could actually change the progression of Alzheimer's?

    您能否評論一下您對幾年內 GLP-1 治療是否真的可以改變阿爾茨海默氏症的進展的看法?

  • And then second, with respect to high-dose Trulicity, could you please frame what we should focus on when we see the Phase III data and your planned positioning of that product?

    其次,關於高劑量 Trulicity,當我們看到 III 期數據和您對該產品的計劃定位時,您能否描述一下我們應該關注的內容?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dave.

    謝謝,戴夫。

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

    第一個問題我們先去找丹,然後再找邁克回答第二個問題。 .

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Yes.

    是的。

  • Thanks.

    謝謝。

  • Of course, we're aware of the comments that Novo has made on GLP-1s in Alzheimer's disease and the potential there.

    當然,我們知道 Novo 對 GLP-1 在阿爾茨海默病中的評論及其潛力。

  • Look forward to seeing data from that first trial.

    期待看到第一次試驗的數據。

  • Look, I think that we know that GLP-1 treatment has beneficial cardiovascular outcomes, including we've seen reductions on stroke.

    看,我認為我們知道 GLP-1 治療具有有益的心血管結果,包括我們已經看到中風的減少。

  • Probably that's the tip of the iceberg, and there's other sort of micro infarcts that are decreased by GLP-1 therapy that could, over time, contribute to a slower rate of cognitive decline.

    可能這只是冰山一角,還有其他類型的微梗塞可以通過 GLP-1 療法減少,隨著時間的推移,這些微梗塞可能會導致認知能力下降的速度變慢。

  • Is there a direct effect of GLP-1s on Alzheimer's pathology?

    GLP-1 對阿爾茨海默病的病理學有直接影響嗎?

  • I think that's not yet known.

    我認為這還不得而知。

  • So we'll watch how the field evolves.

    因此,我們將觀察該領域是如何發展的。

  • If it turns out that there are great opportunities, I think we have a best-in-class incretin in the form of tirzepatide, and we'd be open to future opportunities with it.

    如果事實證明有很大的機會,我認為我們有一種一流的腸促胰島素,以 tirzepatide 的形式,我們會對未來的機會持開放態度。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • Mike?

    麥克風?

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

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

  • David, thanks for your question on our favorite subject.

    大衛,感謝您就我們最喜歡的主題提出的問題。

  • Trulicity had another great quarter, growing by 32% on volume and 29% on revenue.

    Trulicity 又迎來了一個出色的季度,銷量增長 32%,收入增長 29%。

  • We're still quite excited about the overall GLP market growth.

    我們仍然對 GLP 市場的整體增長感到非常興奮。

  • The 52-week rate was at 29.7% while the monthly grade in December was at 31.5%.

    52 週的比率為 29.7%,而 12 月的月度比率為 31.5%。

  • So the market continues to grow.

    所以市場繼續增長。

  • And Trulicity continues to hold up in a very strong market share leadership position outpacing TRx class growth in the face of semaglutide product launches.

    面對 semaglutide 產品的推出,Trulicity 繼續保持非常強大的市場份額領先地位,超過了 TRx 類別的增長。

  • So we expect that both the new Trulicity REWIND as well as the high-dose label enhancements will continue to drive class growth as well as solidify our market leadership position place.

    因此,我們預計新的 Trulicity REWIND 和高劑量標籤增強功能將繼續推動類別增長並鞏固我們的市場領導地位。

  • So we're excited about that I think as you take a look at the results there, take a look at increased -- or the A1c results as well as the weight loss results.

    因此,我們對此感到興奮,我認為當您查看那裡的結果時,請查看增加的 - 或 A1c 結果以及減肥結果。

  • And what we think is the strength of Trulicity is the fact that you get real-world benefits by having powerful efficacy simply delivered.

    我們認為 Trulicity 的優勢在於,您可以通過簡單地提供強大的功效來獲得現實世界的好處。

  • And this will just give people using Trulicity another reason to stay on it.

    這只會給使用 Trulicity 的人們提供另一個繼續使用它的理由。

  • Operator

    Operator

  • Our next question comes from the line of Terence Flynn from Goldman Sachs.

    我們的下一個問題來自高盛的 Terence Flynn。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • The first one is on tirzepatide in the CVOT trial.

    第一個是 CVOT 試驗中的替西帕肽。

  • I was wondering if you can share any more details on the stats or powering assumptions there as well as the discontinuation rate that you're assuming in the arms of the trial.

    我想知道您是否可以分享有關那裡的統計數據或支持假設的更多詳細信息,以及您在試驗中假設的停藥率。

  • And then for Emgality, you mentioned looking to the next phase of growth here in the primary care market.

    然後對於 Emgality,您提到在初級保健市場尋找下一階段的增長。

  • What are some of the markers beyond, obviously, sales that we should look to in terms of gauging successful uptake there?

    顯然,在衡量那裡的成功吸收方面,我們應該關注哪些超出銷售額的指標?

  • And then any thoughts on potential impact from oral CGRPs?

    然後對口頭 CGRP 的潛在影響有何想法?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Okay.

    好的。

  • Thanks.

    謝謝。

  • We'll go to Dan for tirzepatide and then Mike and then Patrik for the oral CGRP question.

    我們將向 Dan 詢問 tirzepatide,然後向 Mike 和 Patrik 詢問口頭 CGRP 問題。

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Yes.

    是的。

  • Thanks for your question asking for more detail on the tirzepatide, SURPASS-CVOT trial design.

    感謝您詢問有關 tirzepatide、SURPASS-CVOT 試驗設計的更多詳細信息。

  • I think at this moment, we don't sort of comment on any of the finer details around clinical trial design and dropout rates.

    我認為目前,我們不會對有關臨床試驗設計和退出率的任何細節發表評論。

  • But I would say that having a trial like this where it's a head-to-head with 2 great active drugs, one on each arm, should be a very compelling opportunity for enrolling physicians and a great opportunity for treatment for patients as well.

    但我想說,像這樣的試驗,它是與兩種偉大的活性藥物進行正面交鋒的試驗,每隻手臂一個,這對於招募醫生來說應該是一個非常有吸引力的機會,也是對患者進行治療的一個很好的機會。

  • So I think that those kinds of factors should help with both enrollments and retention in the trial.

    所以我認為這些因素應該有助於試驗的註冊和保留。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Dan.

    謝謝,丹。

  • Mike?

    麥克風?

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

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

  • I would agree.

    我會同意的。

  • I think as we look at the opportunity and really learn from what providers and payers want, they want active comparators.

    我認為,當我們看到機會並真正從提供者和付款人想要的東西中學習時,他們想要積極的比較器。

  • I think this provides a lot of value, a lot of insights into the incremental value of one product over another product.

    我認為這提供了很多價值,可以深入了解一種產品相對於另一種產品的增量價值。

  • And so obviously, doing a head-to-head trial versus Trulicity is a bold bet, but I think it really reinforces the confidence we have in tirzepatide in this population.

    很明顯,與 Trulicity 進行正面對比試驗是一個大膽的賭注,但我認為這確實增強了我們對這一人群中 tirzepatide 的信心。

  • So we're very excited about the study.

    所以我們對這項研究感到非常興奮。

  • It is a bold bet but one that we're very excited about the potential of this product and CVOT.

    這是一個大膽的賭注,但我們對這款產品和 CVOT 的潛力感到非常興奮。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks.

    謝謝。

  • 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.

    謝謝你。

  • If we look up on the prevention market, we have currently 6 million patients eligible for prevention treatment in the U.S., but only 3 million of those are being treated.

    如果我們看一下預防市場,我們目前在美國有 600 萬患者有資格接受預防治療,但其中只有 300 萬正在接受治療。

  • So that's a big opportunity for us with the increased competition in the marketplace as well to drive patient activation.

    因此,隨著市場競爭的加劇以及推動患者激活,這對我們來說是一個巨大的機會。

  • And specifically for Emgality, if we look upon the prescriber base today, it's relatively limited.

    特別是對於 Emgality,如果我們看看今天的處方者基礎,它是相對有限的。

  • And only 15% of our targets are currently regularly prescribing Emgality.

    目前,我們的目標中只有 15% 定期開處方 Emgality。

  • So that's where we see a tremendous opportunity both in specialty care as well as in primary care.

    因此,我們在專業護理和初級護理中都看到了巨大的機會。

  • In terms of the oral CGRPs, I think it's important to have in mind that they are only approved or will be approved for the treatment of acute migraine this year, and the prevention indication is coming later on.

    就口服 CGRP 而言,我認為重要的是要記住,它們今年僅被批准或將被批准用於治療急性偏頭痛,而預防適應症將在稍後推出。

  • We are very confident with the profile of Emgality, particularly taking into account that we are now the market leader and the preferred CGRP in the marketplace and particularly with the differentiation we have in the label with both efficacy at 50%, 75% and 100% level and also the convenience that the device offers from the same device platform as Trulicity.

    我們對 Emgality 的形象非常有信心,特別是考慮到我們現在是市場領導者和市場上首選的 CGRP,特別是我們在標籤中的差異化,其功效分別為 50%、75% 和 100%水平以及該設備從與 Trulicity 相同的設備平台提供的便利性。

  • The oral CGRPs will be competing in acute space, and we are also very excited about the announcement that was the prepublication notice from the DEA that was publicly displayed this morning and will result in an announcement in the federal register tomorrow enable us to bring Reyvow to the marketplace probably late next week.

    口頭 CGRP 將在激烈的空間中競爭,我們也對今天早上公開展示的 DEA 發布前通知的公告感到非常興奮,並將導致明天在聯邦登記處發佈公告,使我們能夠將 Reyvow 帶到市場可能下週晚些時候。

  • And that's where we have a tremendous opportunity to bring more value in the space of acute migraine.

    這就是我們在急性偏頭痛領域帶來更多價值的巨大機會。

  • And for the first time, we will be able to talk about complete pain elimination already after 2 hours with 1 single dose of Reyvow.

    並且第一次,我們將能夠在 2 小時後用 1 單劑量的 Reyvow 談論完全消除疼痛。

  • And not just complete pain elimination, but also complete elimination of bothersome symptoms such as sun phobia, light sensitivity and nausea.

    而且不僅完全消除了疼痛,而且還完全消除了煩人的症狀,例如太陽恐懼症、光敏感和噁心。

  • So we believe that we are very well positioned both in the preventive space as well as the acute space, but patient activation will be key.

    因此,我們相信我們在預防領域和急性領域都處於非常有利的位置,但患者的激活將是關鍵。

  • And that's something that will be beneficial with also new entrants in the marketplace.

    這對於市場上的新進入者也將是有益的。

  • Operator

    Operator

  • Our next question will come from the line of Steve Scala from Cowen.

    我們的下一個問題將來自 Cowen 的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I have a couple of questions.

    我有一些問題。

  • I'll take the other side of an earlier question and suggest it would be surprising if DIAN-TU didn't hit its end point, given the signal you saw in the EXPEDITION trials and the fact that DIAN-TU is testing a higher dose in a more homogeneous population for a longer time with a tailor-made end point.

    考慮到您在 EXPEDITION 試驗中看到的信號以及 DIAN-TU 正在測試更高劑量的事實,我將採取先前問題的另一面並建議如果 DIAN-TU 沒有達到其終點,那將是令人驚訝的在更同質的人群中使用量身定制的終點更長時間。

  • So Dan, I'm trying to understand your pessimism.

    所以丹,我試圖理解你的悲觀情緒。

  • And maybe you could please tell us on which of the points that I stated you disagree.

    也許你可以告訴我們我所說的你不同意的哪一點。

  • And then there are 4 components to the primary end point.

    然後有 4 個組件到主要終點。

  • Do you need to hit all 4 to achieve success?

    你需要擊中所有4個才能取得成功嗎?

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Steve.

    謝謝,史蒂夫。

  • Dan?

    擔?

  • Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

    Daniel M. Skovronsky - Senior VP & Chief Scientific Officer

  • Okay, Steve.

    好的,史蒂夫。

  • So look, I think most of the comments you said are right.

    所以看,我認為你說的大多數評論都是正確的。

  • The importance of those factors in the outcome of the study is what we don't know.

    這些因素在研究結果中的重要性是我們不知道的。

  • And there are other factors, as I said earlier, going against us here.

    正如我之前所說,還有其他因素在這裡對我們不利。

  • The one that gives -- should give anyone the most pause, I think, is the small sample size.

    我認為,最應該讓任何人停下來的是樣本量小。

  • And Alzheimer's trials are, I think, even in large trials, notorious for surprising us because of the heterogeneity of the effect and variability of the outcome measures.

    我認為,即使在大型試驗中,阿爾茨海默氏症試驗也因效果的異質性和結果測量的可變性而臭名昭著。

  • So it's factors like that, that could make it difficult to really know what is true.

    因此,諸如此類的因素可能使我們很難真正知道什麼是真實的。

  • Look, I still think it's, regardless, an interesting scientific question.

    看,無論如何,我仍然認為這是一個有趣的科學問題。

  • A partner experiment, we'll look forward to seeing the data.

    一個合作夥伴的實驗,我們期待看到數據。

  • With respect to the specifics around the composite, I think the nature of a composite is that you have to hit the overall composite score as the primary end point, which could be driven by the various sub-measures or not.

    關於復合材料的細節,我認為複合材料的本質是您必須將整體綜合得分作為主要終點,這可能由各種子措施驅動或不驅動。

  • But as you pointed out, this was custom-made for this trial.

    但正如你所指出的,這是為這次試驗定制的。

  • Operator

    Operator

  • We have a question from the line of Navin Jacob from UBS.

    我們有一個來自瑞銀的 Navin Jacob 的問題。

  • Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

    Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

  • Just on Verzenio.

    就在 Verzenio 上。

  • Pfizer has slightly delayed its IBRANCE adjuvant trial PALLAS to early 2021.

    輝瑞已將其 IBRANCE 輔助試驗 PALLAS 略微推遲到 2021 年初。

  • Wondering -- and they highlight the event rate progressing much slower.

    想知道——他們強調事件發生率進展得慢得多。

  • Wondering how, relative to your expectations, the event rate has been progressing in monarchE?

    想知道相對於您的預期,monarchE 中的事件率是如何發展的?

  • And is the time line still for an early 2021 readout?

    2021 年初的讀數是否還有時間線?

  • And any color on the potential for an interim would be appreciated.

    任何關於臨時潛力的顏色都將不勝感激。

  • That's on Verzenio.

    那是在 Verzenio 上。

  • And then just on Humalog, the -- I think your press release suggested that pricing in the U.S. benefit from a better segment mix.

    然後就在 Humalog 上,我認為您的新聞稿表明美國的定價受益於更好的細分市場組合。

  • Is that because of a volume shift to the Humalog authorized generic and that's assuming that the authorized generic is being recorded within the Humalog revenue line.

    這是因為數量轉移到 Humalog 授權仿製藥,並且假設授權仿製藥被記錄在 Humalog 收入線中。

  • I just wanted any -- if you could provide any clarity on that.

    我只是想要任何——如果你能提供任何澄清的話。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Great.

    偉大的。

  • Thank you.

    謝謝你。

  • We'll go to Anne for the question on Verzenio and Mike for the question on Humalog.

    我們將向 Anne 詢問有關 Verzenio 的問題,向 Mike 詢問有關 Humalog 的問題。

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

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

  • Navin, thanks for the question on Verzenio.

    Navin,感謝 Verzenio 的問題。

  • So as you know, we have not disclosed any interim analysis.

    如你所知,我們沒有披露任何中期分析。

  • Now this is an event-driven trial, similar to PALLAS.

    現在這是一個事件驅動的試驗,類似於 PALLAS。

  • But our estimates make us quite confident that we're looking at a readout in the first half of 2021.

    但我們的估計讓我們非常有信心,我們正在查看 2021 年上半年的數據。

  • So we continue to expect that.

    所以我們繼續期待。

  • And as you know, the trial enrolled remarkably well.

    如您所知,該試驗的註冊情況非常好。

  • And so we're able to roll ahead of schedule which helps obviously drive the event rate for that.

    因此,我們能夠提前進行,這顯然有助於推動事件發生率。

  • And again, we specifically designed this trial with a high-risk population.

    同樣,我們專門針對高危人群設計了這項試驗。

  • And that was both a strategy of where we believe that Verzenio would really differentiate, but as well, it drove the speed of the trial.

    這既是我們認為 Verzenio 真正與眾不同的策略,也推動了試驗的速度。

  • So again, we feel quite confident in that.

    再說一次,我們對此充滿信心。

  • As you know, the positive MONARCH-2 overall survival results, particularly as we saw those with primary resistance and visceral disease, really, an 8-month survival benefit in patients with visceral disease really reinforce our confidence in the potential success of monarchE.

    如您所知,陽性的 MONARCH-2 總體生存結果,特別是當我們看到那些患有原發性耐藥和內臟疾病的患者時,內臟疾病患者的 8 個月生存獲益確實增強了我們對 monarchE 潛在成功的信心。

  • So we designed it with that high-risk population and really used what we think are thoughtful selection factors that physicians use today to make prescribing decisions in that adjuvant setting.

    因此,我們針對高風險人群設計了它,並真正使用了我們認為是醫生今天使用的深思熟慮的選擇因素,以在該輔助環境中做出處方決定。

  • So things like the number of nodes involved, the tumor size and the measure of proliferation.

    因此,諸如涉及的節點數量、腫瘤大小和增殖量度之類的東西。

  • And so we feel quite confident in the design of this study and, again, look forward to that readout in 2021.

    因此,我們對這項研究的設計充滿信心,並再次期待 2021 年的結果。

  • 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

  • Navin, thanks for your question on Humalog.

    Navin,感謝您對 Humalog 的提問。

  • The biggest driver in Humalog segment mix is the fact that with Humalog's uptake, they are taking volume away from Humalog in Medicaid since our Medicaid rebate rates are essentially 100% that TRx decline actually doesn't have -- has a flat or positive impact on net revenues for Humalog.

    Humalog 細分市場組合的最大驅動因素是,隨著 Humalog 的吸收,他們正在從醫療補助中的 Humalog 中抽走數量,因為我們的醫療補助回扣率基本上是 TRx 下降實際上沒有的 100%——對Humalog 的淨收入。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • And just to confirm, the AG products are consolidated into the Humalog.

    只是為了確認,AG 產品被合併到 Humalog 中。

  • Kevin Hern - VP of IR

    Kevin Hern - VP of IR

  • Thanks, Mike.

    謝謝,邁克。

  • Navin, thanks for your questions.

    納文,謝謝你的提問。

  • We'll go to Dave for the close.

    我們將去戴夫為結束。

  • David A. Ricks - Chairman, CEO & President

    David A. Ricks - Chairman, CEO & President

  • Okay.

    好的。

  • Thank you all.

    謝謝你們。

  • I appreciate your participation in today's earnings call and your interest in Eli Lilly and Company.

    感謝您參加今天的財報電話會議以及您對禮來公司的興趣。

  • 2019 was a strong year for the company, and we anticipate another great year in 2020.

    2019 年對公司來說是強勁的一年,我們預計 2020 年將是另一個偉大的一年。

  • We remain focused on executing our innovation-based strategy to bring new medicines to patients and create value for our shareholders.

    我們仍然專注於執行我們以創新為基礎的戰略,為患者帶來新藥並為我們的股東創造價值。

  • With our strong commercial portfolio complemented by a pipeline of exciting opportunities, Lilly continues to be a compelling investment.

    憑藉我們強大的商業投資組合以及一系列令人興奮的機會,禮來將繼續成為一項引人注目的投資。

  • Thanks again for dialing in.

    再次感謝您撥入。

  • Please follow up with our Investor Relations team if you have any additional questions we weren't able to address on today's call.

    如果您有任何其他問題我們無法在今天的電話會議中解決,請與我們的投資者關係團隊聯繫。

  • Hope you have a great day.

    希望你有一個美好的一天。

  • Operator

    Operator

  • Thank you.

    謝謝你。

  • Ladies and gentlemen, this conference will be available for replay after 11:15 today through January 30, 2021.

    女士們,先生們,本次會議將於今天 11:15 後至 2021 年 1 月 30 日期間重播。

  • You may access the AT&T teleconference replay system at any time by dialing 1 (800) 475-6701 and entering the access code of 2544079 and internationally, (320) 365-3844 with an access code of 2544079.

    您可以隨時通過撥打 1 (800) 475-6701 並輸入接入碼 2544079 和國際電話 (320) 365-3844 以及接入碼 2544079 來訪問 AT&T 電話會議重播系統。

  • That does conclude our conference for today.

    這確實結束了我們今天的會議。

  • Thank for your participation and for using AT&T Executive Teleconference.

    感謝您的參與和使用 AT&T 行政電話會議。

  • You may now disconnect.

    您現在可以斷開連接。