禮來公司 (LLY) 2025 Q1 法說會逐字稿

內容摘要

禮來公司投資者關係高級副總裁 Mike Czapar 與多位公司高管主持了 2025 年第一季度收益電話會議,討論了以非 GAAP 財務指標為重點的預測和前瞻性聲明。該公司的收入有所增長,產品線不斷完善,其口服 GLP-1 orforglipron 治療 2 型糖尿病患者的 III 期臨床數據也取得了積極成果。

他們實現了關鍵的管道里程碑,包括產品批准和新項目。該公司第一季財務表現強勁,營收成長45%,毛利率增至83.5%。儘管貿易和國際關係存在不確定性,但他們仍專注於開發新藥。

討論還涉及定價策略、市場動態以及各種臨床試驗和產品發布的最新情況。該公司對其未來成長和市場影響仍然保持樂觀。

完整原文

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

  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q1 2025 earnings conference call. (Operator Instructions) I would now like to turn the conference over to your host, Mike Czapar, Senior Vice President of Investor Relations. Please go ahead.

    女士們,先生們,感謝你們的支持,歡迎參加禮來公司 2025 年第一季財報電話會議。(操作員指示)現在,我想將會議交給主持人、投資者關係高級副總裁 Mike Czapar。請繼續。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Good morning. Thank you for joining us for Eli Lilly company's Q1 2025 Earnings Call. I'm Mike Czapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO; Lucas Montarce, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology; Anne White, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly International; Jake Van Naarden, President of Lilly Oncology; and Patrik Johnson, President of Cardiometabolic Metabolic Health and Lilly USA.

    早安.感謝您參加禮來公司 2025 年第一季財報電話會議。我是投資者關係資深副總裁 Mike Czapar。參加今天電話會議的還有禮來公司董事長兼首席執行官戴夫·里克斯 (Dave Ricks);盧卡斯·蒙塔斯,首席財務官;禮來免疫學首席科學官兼總裁 Dan Skovronsky 博士;禮來神經科學公司總裁 Anne White;禮來國際總裁 Ilya Yuffa; Jake Van Naarden,禮來神經科學公司總裁 Anne White;禮來國際總裁 Ilya Yuffa; Jake Van Naarden,禮來腫瘤學總裁以及心臟代謝健康和美國禮來。

  • We're also joined by Mark Keman, Wes Tall and Wai Wong of the Investor Relations team. During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to several factors, including those listed on slide 4. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community.

    我們也邀請了投資者關係團隊的 Mark Keman、Wes Tall 和 Wai Wong。在本次電話會議中,我們預計將根據目前的預期做出預測和前瞻性陳述。我們的實際結果可能會因多種因素而存在重大差異,包括投影片 4 中列出的因素。有關可能導致實際結果出現重大差異的因素的更多信息,包含在我們最新的 10-K 表格以及隨後向美國證券交易委員會提交的文件中。我們提供的有關我們的產品和管道的資訊是為了投資界的利益。

  • It is not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note that our commentary will focus on our non-GAAP financial measures.

    它不具有宣傳目的,也不足以規定決策。當我們轉到準備好的評論時,請注意我們的評論將集中於我們的非公認會計準則財務指標。

  • Now I'll turn the call over to Dave.

    現在我將把電話轉給戴夫。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Mike. Q1 was another exciting quarter. We increased our revenue, advanced our pipeline, invested to drive future growth and share the first Phase III clinical data from our oral GLP-1 orforglipron. Dan will share more detail during the R&D update, but we're pleased with the results from the G1 trial for orforglipron in patients with Type 2 diabetes.

    謝謝你,麥克。第一季又是一個令人興奮的季度。我們增加了收入,推進了我們的產品線,投資推動未來成長,並分享了我們的口服 GLP-1 orforglipron 的第一個 III 期臨床數據。Dan 將在研發更新期間分享更多細節,但我們對 orforglipron 對 2 型糖尿病患者的 G1 試驗結果感到滿意。

  • These data met our expectations and are the first step to delivering our overall goal for the program, which is to create a medicine that offers injectable GLP-1 like efficacy, safety and tolerability with the convenience of a once-daily pill that can be manufactured at scale to meet global demand.

    這些數據符合我們的預期,也是實現該計劃總體目標的第一步,即創造一種具有註射 GLP-1 般的功效、安全性和耐受性的藥物,同時又具有每日一次服用藥丸的便利性,可以大規模生產以滿足全球需求。

  • This scientific breakthrough has the potential to eventually impact hundreds of billions of people around the world with chronic diseases. And we expect Phase III data from seven global clinical trials to read out over the next 12 months across Type 2 diabetes and obesity.

    這項科學突破最終有可能影響全球數千億患有慢性疾病的人。我們預計,未來 12 個月內,全球七項臨床試驗的 III 期數據將涵蓋第 2 型糖尿病和肥胖症。

  • We also expect potential regulatory submissions for obesity to begin worldwide by the end of 2025. On slide 6, we list Q1 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 45% compared to Q1 of 2024.

    我們也預計,到 2025 年底,全球範圍內將開始提交針對肥胖症的潛在監管文件。在第 6 張投影片上,我們列出了第一季的財務指標,並重點介紹了與我們的策略交付成果相關的進展。與 2024 年第一季相比,營收成長了 45%。

  • Our key products defined as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio and Zepbound, grew by more than $4 billion and now account for $7.5 billion of revenue for the company. In addition to the orforglipron readout, we achieved several other key pipeline milestones this quarter. They include the approval of Jaypirca in the EU for CLL. The approval of Omvoh in the US, EU and Japan for Crohn's disease and the initiation of a Phase III program for olomorasib in resected adjuvant non-small cell lung cancer. We also shared plans to more than double our manufacturing investment in the US.

    我們的主要產品包括 Ebglyss、Jaypirca、Kisunla、Mounjaro、Omvoh、Verzenio 和 Zepbound,成長超過 40 億美元,目前為公司帶來 75 億美元的收入。除了 orforglipron 讀數之外,本季度我們還實現了其他幾個關鍵的管道里程碑。其中包括歐盟批准 Jaypirca 用於治療慢性淋巴細胞白血病。美國、歐盟和日本批准 Omvoh 用於治療克隆氏症,並啟動 olomorasib 用於治療切除的輔助非小細胞肺癌的 III 期臨床試驗。我們也分享了將在美國製造業投資增加一倍以上的計畫。

  • In total, we've announced over $50 billion of new US manufacturing investments since 2020. We including our most recent announcement to build four new facilities, of which three will be API or active pharmaceutical ingredient facilities. Lastly, we distributed $1.3 billion to dividends in the first quarter and executed a $1.2 billion share repurchase. We realize there's a lot of investor focus right now on tariffs and trade.

    總體而言,自 2020 年以來,我們已宣布對美國製造業進行超過 500 億美元的新投資。我們最近宣布將建造四個新設施,其中三個將是 API 或活性藥物成分設施。最後,我們在第一季派發了 13 億美元的股息,並執行了 12 億美元的股票回購。我們意識到目前許多投資者關注關稅和貿易問題。

  • So I'll make a few comments that reflect our current views on these complex and quite dynamic matters. We support the US government's goals to increase domestic investment. However, we don't believe tariffs are the right mechanism. Enhanced tax incentives and/or the extension of the Tax Cut and Job Act are better tools to achieve their goals.

    因此,我將發表一些評論,反映我們對這些複雜且相當動態的問題的當前看法。我們支持美國政府增加國內投資的目標。然而,我們並不認為關稅是正確的機制。加強稅收激勵和/或延長減稅與就業法案是實現其目標的更好工具。

  • The announcement -- the announced tariffs currently in fact, do not materially change Lilly's 2025 financial outlook. However, the expansion of tariffs in other geographies or increases in retaliatory tariffs would have a negative effect on Lilly and for our industry. As a company, Lilly has a large US manufacturing footprint with 10 active projects ongoing to build and expand new sites. Upon completion of our manufacturing agenda, we'll be able to supply medicines for the US market entirely from US facilities as well as increase the volume of medicines we export.

    這項公告——事實上,目前宣布的關稅不會對禮來公司 2025 年的財務前景產生實質改變。然而,其他地區的關稅擴大或報復性關稅的增加將對禮來公司和我們的產業產生負面影響。作為一家公司,禮來公司在美國擁有龐大的製造基地,目前有 10 個正在進行的項目,用於建造和擴大新工廠。一旦完成我們的製造計劃,我們將能夠完全從美國工廠向美國市場供應藥品,並增加我們出口的藥品數量。

  • We will continue to execute our US manufacturing agenda. However, we urge the administration to negotiate deals with key trading partners as soon as possible the level the playing field for American exporters like Lilly and remove harmful tariffs and nontariff market access barriers in the developed economies.

    我們將繼續執行我們的美國製造業議程。然而,我們敦促政府盡快與主要貿易夥伴進行談判,為禮來等美國出口商提供公平的競爭環境,並取消已開發經濟體的有害關稅和非關稅市場准入壁壘。

  • Now I'll turn the call over to Lucas to review our Q1 financial results.

    現在我將把電話轉給盧卡斯來回顧我們的第一季財務表現。

  • Lucas Montarce - Executive Vice President and Chief Financial Officer

    Lucas Montarce - Executive Vice President and Chief Financial Officer

  • Thanks, Dave. As shown on slide 7, Q1 was another strong quarter of financial performance with revenue growing 45% compared to Q1 2024, driven by our key products. Gross margin as a percentage of revenue was 83.5% in Q1, an increase of 1 percentage points versus the same quarter last year. Gross margin was positively impacted by improved production costs and favorable product mix, which were partially offset by lower realized prices.

    謝謝,戴夫。如投影片 7 所示,第一季的財務表現再創佳績,在主要產品的推動下,營收與 2024 年第一季相比成長了 45%。第一季毛利率為83.5%,較去年同期增加1個百分點。生產成本的改善和有利的產品組合對毛利率產生了積極影響,但實際價格的下降部分抵消了這些影響。

  • Marketing, selling and administrative expenses increased 26% as we invested in promotional activities to support new launches across our therapeutic areas. R&D expenses increased 8%, driven by higher development expenses for late-stage assets and additional investments in early-stage research. In Q1, we recognized acquired IP R&D charges of $1.57 billion, primarily related to the previously announced acquisition of Scorpion Therapeutics PI3K alpha inhibitor program.

    由於我們投資促銷活動來支持我們治療領域的新產品發布,行銷、銷售和管理費用增加了 26%。研發費用增加了 8%,這主要是由於後期資產的開發費用增加以及早期研究的額外投資。在第一季度,我們確認了 15.7 億美元的收購 IP 研發費用,主要與先前宣布的收購 Scorpion Therapeutics PI3K 阿爾法抑制劑專案有關。

  • In total, IP R&D charges negatively impacted earnings per share by $1.72. Our non-GAAP performance margin, which we define as gross margin less R&D, marketing, selling and administrative expenses as a percentage of revenue was 42.6%, an increase of over 11 percentage points from Q1 2024. Our Q1 effective tax rate was 20.2%.

    總體而言,智慧財產權研發費用對每股收益產生了 1.72 美元的負面影響。我們的非公認會計準則業績利潤率(定義為毛利率減去研發、行銷、銷售和管理費用佔收入的百分比)為 42.6%,比 2024 年第一季成長了 11 個百分點以上。我們第一季的有效稅率為 20.2%。

  • The Q1 tax rate was negatively impacted by the previously described non-deductible and acquired IP R&D charges. At the bottom line, we delivered earnings per share of $3.34 in Q1, inclusive of the negative impact of $1.72 from acquired IP R&D charges. This compares to earnings per share of $2.58 in Q1 2024, inclusive of $0.10 of acquired IP R&D charges. On slide 8, we quantify the effect of price, rate and volume on revenue growth.

    第一季的稅率受到先前描述的不可扣除和獲得的知識產權研發費用的負面影響。總體而言,我們第一季的每股收益為 3.34 美元,其中包括收購 IP 研發費用帶來的 1.72 美元的負面影響。相比之下,2024 年第一季每股收益為 2.58 美元,其中包括 0.10 美元的收購 IP 研發費用。在第 8 張投影片上,我們量化了價格、利率和數量對收入成長的影響。

  • US revenue increased 49% in Q1 driven by strong volume growth of our key products, including Zepbound and Mounjaro, partially offset by a 7% decline in price. Moving to Europe. Revenue increased 71% in constant currency. Q1 2025 was positively impacted by a onetime benefit of $370 million related to further restructuring our alliance with Boehringer Ingelheim. Excluding this benefit, constant currency revenue grew 46% driven primarily by Mounjaro, partially offset by a 7% decline in price.

    第一季度,美國營收成長了 49%,這得益於我們的主要產品(包括 Zepbound 和 Mounjaro)的銷量強勁增長,但價格下降了 7%,部分抵消了這一增長。移居歐洲。以固定匯率計算,營收成長了 71%。2025 年第一季度,我們與勃林格殷格翰的聯盟進一步重組帶來了 3.7 億美元的一次性收益,對其產生了積極影響。除去這項收益,固定匯率收入增長了 46%,這主要得益於 Mounjaro 的推動,但價格下降 7% 部分抵消了這一增長。

  • Japan revenue grew 15% in constant currency, with volume growing 16%, driven by Mounjaro and Jardiance. Moving to China. Q1 revenue increased 21% in constant currency. Volume growth was primarily driven by Mounjaro. As a reminder, we recently initiated a limited Mounjaro launch in China with the expectation to gradually increase commercial launch in the second half of 2025 as supply becomes available.

    在 Mounjaro 和 Jardiance 的推動下,日本營收以固定匯率計算成長了 15%,銷量成長了 16%。移居中國。以固定匯率計算,第一季營收成長了 21%。銷售成長主要受 Mounjaro 推動。提醒一下,我們最近在中國啟動了 Mounjaro 的限量發布,預計隨著供應的充足,將在 2025 年下半年逐步增加商業發布。

  • Revenue in the rest of the world increased 17% in constant currency, primarily driven by volume growth from Mounjaro and, to a lesser extent, Verzenio. Slide 9 provides an update on the performance of our key products. Beginning with immunology, we have seen encouraging US uptick of Ebglyss in atopic dermatitis. New patient starts are increasing, and we are making good progress securing access and reimbursement.

    以固定匯率計算,全球其他地區的收入成長了 17%,這主要得益於 Mounjaro 的銷售成長,以及 Verzenio(較小程度)的銷售成長。幻燈片 9 提供了我們主要產品性能的最新情況。從免疫學開始,我們看到美國使用 Ebglyss 治療異位性皮膚炎的病例呈現令人鼓舞的成長勢頭。新患者數量正在增加,我們在確保醫療服務可近性和報銷方面也取得了良好進展。

  • Ebglyss is currently covered by two of the largest pharmacy benefit managers, and we expect further access improvement later this year. As of May 1, Ebglyss will be reimbursed on plans that account for 60% of people who are commercially insured.

    Ebglyss 目前受到兩家最大的藥品福利管理公司的覆蓋,我們預計今年稍後其訪問管道將進一步改善。自 5 月 1 日起,Ebglyss 將為佔商業保險人數 60% 的計劃提供報銷。

  • For Omvoh, we have received approval of Crohn's disease across the globe as a second indication. Commercial activities is going to drive new patient starts in this larger patient population. Moving to oncology. Jaypirca was recently approved in Europe for relapsed or refractory CLL in patients who previously treated with a BTK inhibitor. We anticipate launches beginning in Q2.

    對於 Omvoh,我們已獲得全球批准用於治療克羅恩病,作為其第二種適應症。商業活動將會推動這個更大患者群體中新患者的出現。轉向腫瘤學。Jaypirca 最近在歐洲獲得批准,用於治療先前接受 BTK 抑制劑治療的複發或難治性 CLL 患者。我們預計將於第二季開始發布。

  • We also expect readouts from additional global Phase III trials later this year, which we believe will be important to evaluate Jaypirca in earlier settings of CLL, including a head-to-head comparison with ibrutinib. Verzenio Global sales grew 10% in Q1 as Verzenio continues to be the standard of carrying high-risk early breast cancer.

    我們也預計今年稍後會有更多全球 III 期試驗的讀數,我們認為這對於評估 Jaypirca 在 CLL 早期治療中的效果非常重要,包括與 ibrutinib 的正面比較。Verzenio 繼續成為治療高風險早期乳癌的標準,其第一季全球銷售額成長了 10%。

  • As expected, we have seen some impact from competition in early breast cancer. However, Verzenio share of market in high-risk early breast cancer is stable and total prescription to continue to grow. US prescription grew by 7% in Q1, partially offset by the wholesaler inventory destocking in the quarter. International volumes for Verzenio grew 30% in Q1.

    正如預期的那樣,我們看到了早期乳癌競爭帶來的一些影響。然而,Verzenio 在高風險早期乳癌市場的份額保持穩定,並且總處方量將繼續增長。美國處方量在第一季增加了 7%,但部分被本季批發商庫存減少所抵消。Verzenio 第一季的國際銷量成長了 30%。

  • Within neuroscience, Kisunla is now approved in 12 countries. We have seen a steady increase in the use of blood-based biomarkers. The conversion rate from diagnosis to treatment and the number of new patients starting treatment in both the US and Japan. While it is encouraging to see progress, we do still expect that it will take some time to build this market.

    在神經科學領域,Kisunla 現已在 12 個國家獲得批准。我們看到血液生物標記的使用穩定增長。美國和日本的診斷到治療的轉換率以及開始治療的新患者數量。雖然看到進展令人鼓舞,但我們仍然預計建立這個市場需要一些時間。

  • We expect US regulatory action for the Modified Dosing Regime for Kisunla in the next few months. Finally, moving to Cardiometabolic Health. Both Mounjaro and Zepbound posted strong revenue growth. Mounjaro sales were $3.8 billion, more than double the same order last year.

    我們預計美國將在未來幾個月內針對 Kisunla 的改良給藥方案採取監管行動。最後,轉向心臟代謝健康。Mounjaro 和 Zepbound 的營收均實現強勁成長。Mounjaro 的銷售額為 38 億美元,比去年同期成長了一倍多。

  • In the US, Mounjaro exited Q1 as the market leader in new prescription within diabetes including analysis. Outside the US, Mounjaro has launched in over 40 countries and Q1 was another quarter of steady sequential growth. We recently launched in India and Mexico and plan to continue with additional countries throughout 2025.

    在美國,Mounjaro 在第一季成為糖尿病新處方(包括分析)市場的領導者。除美國以外,Mounjaro 已在 40 多個國家推出,第一季又實現了穩定的連續成長。我們最近在印度和墨西哥推出了這項服務,並計劃在 2025 年繼續在其他國家開展業務。

  • Our focus internationally is to -- is on seeking reimbursement for Type 2 diabetes and developing the ecosystem to treat obesity as a chronic disease. Zepbound performance was also robust as sales increased by $1.8 billion to $2.3 billion in the quarter.

    我們的國際重點是尋求 2 型糖尿病的報銷,並開發將肥胖症作為慢性疾病進行治療的生態系統。Zepbound 的業績也十分強勁,本季銷售額成長了 18 億美元,達到 23 億美元。

  • Zepbound is the US branded anti-obesity market leader in both total prescription and new prescription, reaching 60% and 74%, respectively, at the end of Q1. We also launched higher dose Zepbound vials adding two additional doses for patients to access Zepbound through the self-pay channel. The update of Zepbound vials has been strong and vials accounted for approximately 10% of total prescription and 25% of new prescriptions in Q1.

    Zepbound 是美國品牌減肥藥市場的領導者,無論是在總處方量還是新處方量方面,第一季末的市佔率分別達到 60% 和 74%。我們還推出了更高劑量的 Zepbound 小瓶,為患者增加了兩劑,以便患者透過自付管道獲得 Zepbound。Zepbound 小瓶的更新非常強勁,小瓶約佔第一季總處方的 10% 和新處方的 25%。

  • On slide 10 is an update on trends in the US increasing analog market, which includes increasing prescriptions in both Type 2 diabetes and obesity. Q1 was another quarter of steady market growth as total prescriptions grew by 46% compared to Q1 2024. Lilly performance was strong as a four-week rolling average share of market increased by 5 percentage-points compared to Q4 2024 and by 10 percentage points compared to the same quarter last year.

    投影片 10 是美國模擬市場成長趨勢的最新情況,其中包括 2 型糖尿病和肥胖症的處方量增加。第一季是市場穩定成長的另一個季度,與 2024 年第一季相比,處方總量增加了 46%。禮來公司業績表現強勁,四周滾動平均市場份額與 2024 年第四季相比增加了 5 個百分點,與去年同期相比增加了 10 個百分點。

  • On slide 11, we provide an update on capital allocation. Moving to slide 12 is our updated 2025 financial guidance. Our performance in Q1 was strong. We are encouraged by the underlying trends we saw across our portfolio of medicines.

    在第 11 張投影片上,我們提供了有關資本配置的最新資訊。第 12 張投影片是我們更新後的 2025 年財務指引。我們第一季的表現非常強勁。我們對所見藥品組合的潛在趨勢感到鼓舞。

  • As a result, we are reforming our revenue and performance margin guidance. Our non-GAAP earnings per share guidance is unchanged, except for Q1 charges related to acquired IP R&D. As Dave mentioned, the situation regarding trade and tariffs remains dynamic.

    因此,我們正在改革我們的收入和業績利潤率指導。除了第一季與收購的智慧財產權研發相關的費用外,我們的非公認會計準則每股收益指引保持不變。正如戴夫所提到的,貿易和關稅情況仍然動態。

  • We continue to monitor the external environment. However, we estimate that the announced tariff currently in effect, will have a limited impact financially, which we have absorbed within our 2025 guide.

    我們將繼續監測外部環境。然而,我們估計,目前生效的已宣布關稅對財務的影響有限,我們已將其納入 2025 年指南中。

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

    現在我將把電話交給丹,介紹我們在研發方面的進展。

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Thanks, Lucas. I'll start with key data from our recently completed orforglipron Phase III trial and provide some context on our development plans and time lines for this important molecule. I've previously said that our hypothesis was that orforglipron could deliver efficacy, safety and tolerability similar to the best seen for available GLP-1 monotherapy injectables.

    謝謝,盧卡斯。我將從我們最近完成的 orforglipron 第三階段試驗的關鍵數據開始,並提供一些有關我們對這一重要分子的開發計劃和時間表的背景資訊。我之前曾說過,我們的假設是,orforglipron 可以提供與現有的 GLP-1 單藥治療注射劑類似的療效、安全性和耐受性。

  • I believe the results from ACHIEVE-1 trial support that hypothesis. Let me start with efficacy. Beginning on slide 13, you can see the reduction of 1.3% to 1.6% for hemoglobin A1C. Given the relatively low baseline of 8.0 in this 40-week monotherapy study, patients on the two highest doses ended the study with a mean A1C of about 6.5%, similar to the lowest levels achieved in trials of other monotherapy GLP-1 agonists. In fact, with orforglipron, more than 65% of patients achieved an A1C less than or equal to 6.5%, which is below the American Diabetes Association's defined threshold for diabetes.

    我相信 ACHIEVE-1 試驗的結果支持這個假設。我先從功效說起。從第 13 張投影片開始,您可以看到血紅蛋白 A1C 減少了 1.3% 至 1.6%。鑑於這項為期 40 週的單一療法研究中的基線相對較低(8.0),服用兩種最高劑量的患者在研究結束時的平均 A1C 約為 6.5%,與其他單一療法 GLP-1 激動劑試驗中達到的最低水平相似。事實上,使用奧格利普隆後,超過 65% 的患者的 A1C 低於或等於 6.5%,低於美國糖尿病協會定義的糖尿病閾值。

  • In a key secondary endpoint, orforglipron also helped people with diabetes lose approximately 16 pounds or 7.9% of their body weight at the highest dose. These data are in line with weight loss demonstrated with existing injectable GLP-1s in patients with diabetes, especially when considering the baseline weight and other demographic factors in this trial.

    在關鍵的次要終點,orforglipron 還幫助糖尿病患者在最高劑量下減輕了約 16 磅或 7.9% 的體重。這些數據與現有的注射用 GLP-1 在糖尿病患者中證明的減肥效果一致,尤其是考慮到本次試驗中的基線體重和其他人口統計因素。

  • Given that the study was only 40 weeks in duration, participants had not yet reached a weight plateau at the conclusion of this study. This result is encouraging as we look ahead to our first Phase III readout in people with obesity, that we expect in Q3.

    鑑於研究僅持續了 40 週,參與者在研究結束時尚未達到體重平台期。當我們展望肥胖族群的第一次 III 期讀數(預計在第三季)時,這個結果令人鼓舞。

  • Most importantly, we were pleased to see the safety profile of orforglipron in this trial. The most common adverse events were gastrointestinal, which is consistent with the GLP-1 class. We did not see any hepatic safety issues in ACHIEVE-1. As you can see on slide 14, discontinuations due to adverse events were low, with only 4% to 8% of patients discontinue orforglipron due to adverse events. The slow and stepwise dose escalation we utilized in Phase III, combined with a relatively long about 24-hour half-life of this molecule resulted in a tolerability profile that matched our expectations and was consistent with weekly injectable GLP-1s.

    最重要的是,我們很高興看到奧格利普龍在這次試驗中的安全性。最常見的不良事件是胃腸道不良事件,這與 GLP-1 類一致。我們沒有發現 ACHIEVE-1 有任何肝臟安全問題。正如您在幻燈片 14 上看到的,由於不良事件而停藥的人數很少,只有 4% 至 8% 的患者由於不良事件而停用格列隆。我們在 III 期臨床試驗中採用的緩慢、逐步增加劑量,加上該分子相對較長的約 24 小時半衰期,使其耐受性符合我們的預期,並且與每週注射一次的 GLP-1 一致。

  • The ACHIEVE-1 full results will be presented at the ADA's 85th Scientific Sessions and will be published in a peer review to term. This was the first of several Phase III trials that will read out for orforglipron. On slide 15, you can see how ACHIEVE-1 fits into the broader orforglipron development program. Over the next 12 months, we expect to get results from four additional diabetes trials where we're setting orforglipron compared to insulin and head-to-head versus other oral diabetes medicines.

    ACHIEVE-1 的完整結果將在 ADA 第 85 屆科學會議上公佈,並將在同行評審中發表。這是奧格利普隆的幾項 III 期試驗中的第一項。在第 15 張投影片上,您可以看到 ACHIEVE-1 如何融入更廣泛的 orforglipron 開發計畫。在接下來的 12 個月中,我們預計將獲得另外四項糖尿病試驗的結果,在這些試驗中,我們將對格列龍與胰島素進行比較,並與其他口服糖尿病藥物進行頭對頭比較。

  • We also expect to get results in our two obesity Phase III trials, one trial in people with obesity without diabetes and a second trial in people with obesity and diabetes. Assuming success in these Phase III programs, we plan to submit orforglipron for obesity in Q4 later this year, followed by Type 2 diabetes in the first half of 2026.

    我們也希望在兩項肥胖症 III 期試驗中獲得結果,一項試驗針對沒有糖尿病的肥胖症患者,另一項試驗針對肥胖症和糖尿病患者。假設這些 III 期計畫取得成功,我們計劃在今年稍後的第四季度提交用於治療肥胖症的 orforglipron 申請,隨後在 2026 年上半年提交用於治療 2 型糖尿病的申請。

  • We also have an ongoing Phase III trial in obesity in the maintenance setting, the Phase III trial in obstructive sleep apnea on obesity and we will initiate a Phase III trial in hypertension later this quarter. We look forward to seeing more data from this robust clinical development program as we continue to find the impact orforglipron can have for patients.

    我們也正在進行維持性肥胖症的 III 期試驗、肥胖症阻塞性睡眠呼吸中止症的 III 期試驗,並且我們將在本季度稍後啟動高血壓的 III 期試驗。我們期待從這個強大的臨床開發計劃中看到更多數據,因為我們將繼續發現奧格列酮對患者的影響。

  • Moving on to other R&D updates since our last call. On the regulatory front, following discussions with the FDA, withdrawn our US application for the heart failure with preserved ejection fraction indication for tirzepatide. We believe the positive Phase III data from the SUMMIT trial do support an indication.

    自上次通話以來,我們繼續討論其他研發更新。在監管方面,經過與 FDA 的討論,我們撤回了在美國申請的用於治療射血分數保留的心臟衰竭的 tirzepatide 的申請。我們相信 SUMMIT 試驗的積極 III 期數據確實支持這一指徵。

  • However, FDA indicated an additional confirmatory clinical trial is required. Regulatory reviews are ongoing in other countries. Continuing with updates in Cardiometabolic Health, we're sharing today plans to initiate a new Phase III trial, studying our triple agonist retatrutide in patients with obesity and chronic low back pain.

    然而,FDA 表示需要進行額外的確認性臨床試驗。其他國家正在進行監管審查。繼續更新心臟代謝健康的最新動態,我們今天分享了啟動一項新的 III 期試驗的計劃,研究我們的三重激動劑瑞他曲肽對肥胖和慢性腰痛患者的作用。

  • We're also announcing today next steps for our Oral Once-Daily program targeting Lipoprotein(a), Muvalaplin. In Phase II data we presented last year, Muvalaplin lowered Lipoprotein(a) levels by up to 85% at the highest tested dose. Based on these data, we plan to initiate a Phase III program later this year in atherosclerotic cardiovascular disease and we're excited about the potential to bring what could be the first-ever oral small molecule approach for lowering Lipoprotein(a) to patients.

    我們今天也宣布了針對脂蛋白 (a) Muvalaplin 的每日一次口服計劃的後續步驟。在我們去年公佈的第二階段數據中,Muvalaplin 在最高測試劑量下將脂蛋白 (a) 水平降低了高達 85%。基於這些數據,我們計劃在今年稍後啟動針對動脈粥狀硬化性心血管疾病的 III 期項目,並且我們很高興能夠為患者帶來有史以來第一種降低脂蛋白 (a) 的口服小分子方法。

  • Moving to oncology. We've now started a new Phase III program with Olomorasib in KRAS G12C mutant resected adjuvant lung cancer. This is a third potential indication that we're simultaneously pursuing for Olomorasib. Across our therapeutic areas, we made good progress in our early phase portfolio, and we advanced five new medicines into Phase I clinical trials, as shown on slide 16. I'll now turn the call back to Dave for closing remarks.

    轉向腫瘤學。我們現在已經啟動了一項新的 III 期計劃,使用 Olomorasib 治療 KRAS G12C 突變型切除輔助肺癌。這是我們正在同時探索的 Olomorasib 的第三個潛在適應症。在我們的治療領域,我們的早期產品組合取得了良好進展,並且我們將五種新藥推進到 I 期臨床試驗,如幻燈片 16 所示。現在我將把電話轉回給戴夫,請他作最後發言。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Dan. We know uncertainties exist right now in trade, tax and international relations. While Lilly is actively engaged in shaping the external environment, we're mostly focused on executing our winning strategy, discovering, developing, and making new medicines that can help people live healthier lives. We made good progress this quarter and we are well positioned to deliver strong and sustained growth going forward.

    謝謝,丹。我們知道目前貿易、稅收和國際關係方面存在不確定性。雖然禮來公司積極致力於塑造外部環境,但我們主要專注於執行我們的勝利策略,發現、開發和製造能夠幫助人們過上更健康生活的新藥。本季我們取得了良好的進展,我們已做好準備,在未來實現強勁、持續的成長。

  • Now I'll turn the call over to Mike to moderate our Q&A session.

    現在我將把電話交給麥克主持我們的問答環節。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Dave. We'd like to take questions from as many callers as possible and consistent with prior quarters, we will respond to one question per caller. And we'll end the call promptly at 11 AM. Paul, please provide the instructions for the Q&A session, and then we're ready for the first caller.

    謝謝,戴夫。我們希望回答盡可能多的來電者的問題,與前幾季一樣,我們將只回答每個來電者的一個問題。我們將於上午 11 點準時結束通話。保羅,請提供問答環節的說明,然後我們就可以準備接聽第一位來電了。

  • Operator

    Operator

  • Certainly, at this time we will be conducting a question-and-answer session. (Operator Instructions)

    當然,這次我們將進行問答環節。(操作員指示)

  • Asad Haider, Goldman Sachs.

    高盛的阿薩德·海德爾 (Asad Haider)。

  • Asad Haider - Analyst

    Asad Haider - Analyst

  • Thanks for taking the question. Dave, just in light of the CVS formulary announcement this morning, Mounjaro Zepbound, there are clearly some investor concerns about the PBM dynamic in obesity, given what we've seen in other big health care markets in the past where two PBMS -- where PBMs spent two companies against each other.

    感謝您回答這個問題。戴夫,鑑於今天早上 CVS 處方集的公告,Mounjaro Zepbound,顯然有些投資者對 PBM 在肥胖症領域的動態感到擔憂,因為我們過去在其他大型醫療保健市場看到過兩家 PBMS——PBM 花費兩家公司相互競爭的情況。

  • So two-part question. Number one, what is your expectation on market share dynamics in the next weeks and months from the CVS formulary loss? And then second, can you talk to your strategy on how you're going to be navigating an environment where we could see PBMs continue to try and restrict formulary access between Zepbound and Wegovy? Thank you.

    所以問題分為兩部分。第一,您對 CVS 藥品處方集遺失後未來幾週和幾個月的市佔率動態有何預期?其次,您能否談談您的策略,即如何在我們可能看到 PBM 繼續嘗試限制 Zepbound 和 Wegovy 之間的處方集訪問的環境中應對這種情況?謝謝。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Yeah, thanks for the question. We're not surprised that said this kind of thing was announced. If we look at what's happening in the market, we're pretty deep into a replacement cycle particularly on obesity and tirzepatide, as we've highlighted on this call, is gaining a lot of market share, basically, most of the growth in the category is happening with our medicine. Of course, the private pay market is an important segment.

    是的,謝謝你的提問。我們對宣布這種事情並不感到驚訝。如果我們觀察市場正在發生的事情,我們會發現我們已經深入到替代週期,特別是在肥胖症和 tirzepatide 方面,正如我們在這次電話會議上強調的那樣,它正在獲得大量的市場份額,基本上,該類別的大部分增長都發生在我們的藥物上。當然,私人支付市場是一個重要的部分。

  • We'd like to grow that segment, and we'd like to grow choice and access in that segment. So we're not interested at all in one of one deals of reducing access and choice for doctors and patients, we want to expand it. So this type of thing is too interesting to us, but it's understandable that it can happen. And obviously, in this one case, did. Our focus is on making better medicines and more accessible medicine.

    我們希望擴大這一細分市場,我們希望增加這一細分市場的選擇和訪問管道。因此,我們對減少醫生和患者的醫療機會和選擇權的交易不感興趣,我們希望擴大它。所以這種事情對我們來說太有趣了,但它的發生也是可以理解的。顯然,就這一案例而言,確實如此。我們的重點是製造更好的藥物和更容易取得的藥物。

  • So orforglipron topic today, excited by the possibility of an oral that could be more widely distributed around the world and here in the US with GLP-1 -- injectable GLP-1 like profile like Dan highlighted. And of course, on driving more advanced therapies as well in combination or triple acting agents like retatrutide. So that's our focus.

    因此,今天的 orforglipron 主題是,我們很高興看到口服藥物有可能在世界範圍內以及在美國更廣泛地分發,並且具有 Dan 強調的 GLP-1 和注射 GLP-1 的特性。當然,我們也致力於推動更先進的療法以及合併用藥或三聯用藥,如瑞他妥肽。這就是我們的重點。

  • It doesn't surprise me that this happen, and we'll work through it, recognizing in this case as well we're talking about the templated lives at CBS and probably opt-in rates for employers in the templated part of their book are pretty low compared to the national average, just to maybe inform your analysis. And we'll work through it.

    發生這種情況並不令我感到驚訝,我們將努力解決這個問題,同時認識到在這種情況下,我們正在談論哥倫比亞廣播公司的模板化生活,並且與全國平均水平相比,其書籍模板部分中雇主的選擇率可能相當低,這也許可以為您的分析提供參考。我們會努力解決這個問題。

  • Our job will be to continue to drive share and preference for our brand. I think the team has done a great job of that year-to-date, and we'll continue to focus on that while we wait for the orfor launch and read the data later this year.

    我們的工作是繼續推動我們品牌的份額和偏好。我認為團隊今年迄今做得非常出色,我們將繼續關注這一點,同時等待 orfor 的發布並在今年晚些時候讀取數據。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Dave. Thanks, Asad. Next question, please.

    謝謝,戴夫。謝謝,阿薩德。請回答下一個問題。

  • Operator

    Operator

  • Geoff Meacham, Citibank.

    花旗銀行的傑夫‧米查姆。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Morning guys. Thanks for the question. For Dan or for Dave, when you look at the positioning of orforglipron, is the ultimate goal to have meaningfully more indications than tirzepatide, just given the oral convenience. I think when you look beyond just weight loss, would seem that broader cardio investment makes sense, but maybe also perhaps combos in I&I or autoimmune or even neuropsych? Thank you.

    大家早安。謝謝你的提問。對 Dan 或 Dave 來說,當你看待 orforglipron 的定位時,最終目標是比 tirzepatide 具有更多的適應症,只考慮到口服的便利性。我認為,當你不僅僅考慮減肥時,更廣泛的有氧運動投資似乎是有意義的,但也許還有免疫與免疫或自體免疫甚至神經心理學的組合?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Geoff. We'll go to Dan talk about the orfor development strategy.

    偉大的。謝謝,傑夫。我們將與丹討論 ORFor 發展策略。

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Thanks, Geoff. And I think you're correctly pointing out that oral medicine like orforglipron could be acceptable for use in a number of broad indications, particularly primary care type indications. That's guided our thinking on indications that we're pursuing I think coming out of this readout, we have even more confidence in this molecule and we'll aggressively pursue whatever direction we think work.

    謝謝,傑夫。我認為您正確地指出,像奧格利普龍這樣的口服藥物可以用於多種廣泛的適應症,特別是初級保健類型的適應症。這指導了我們對正在追求的跡象的思考,我認為從這個讀數來看,我們對這種分子更有信心,我們將積極追求我們認為有效的方向。

  • Combinations surely are on the table where that makes sense for patients, particularly in in these areas where there could be synergy with other mechanisms that probably there are a number of good ideas in immunology and neuroscience, as you point out. Also just a reminder, Geoff, we -- it's not our only oral incretin, we have another molecule behind that, and we're continuing to innovate with even multifunctional orals. So I'm pretty excited about what's yet to come here. And surely, we start with Type 2 diabetes and obesity but more to come.

    只要對患者有意義,組合療法肯定是可以考慮的,特別是在這些可以與其他機制產生協同作用的領域,正如您所指出的,免疫學和神經科學領域可能存在許多好的想法。另外提醒一下,傑夫,這不是我們唯一的口服腸促胰島素,我們還有另一種分子,而且我們正在繼續創新,甚至是多功能口服藥物。因此,我對即將發生的事情感到非常興奮。當然,我們從第 2 型糖尿病和肥胖症開始,但接下來還會有更多。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Dan. On the next caller, please.

    謝謝,丹。請接聽下一位來電。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    摩根大通的克里斯·肖特。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Great, thanks so much. Just another orforglipron data. Just post the data we've seen here. Can you just elaborate a bit more on the role you see orforglipron playing in the core obesity and diabetes market relative to injectables? And maybe as part of that, any thoughts on what type of share you would envision orals taking in the market over time? Thank you.

    太好了,非常感謝。這只是另一個 orforglipron 數據。只需在此處發布我們看到的數據。您能否更詳細地闡述您認為 orforglipron 在核心肥胖症和糖尿病市場相對於注射所扮演的角色?作為其中的一部分,您認為口服藥物隨著時間的推移將在市場上佔據什麼樣的份額?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Chris. We'll go to Patrik to talk about the role of oral in the broader (inaudible) market.

    偉大的。謝謝,克里斯。我們將請帕特里克談論口腔在更廣泛的(聽不清楚)市場中的作用。

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • Thanks a lot, Chris. I think the significant opportunities here for orforglipron. Just look at the Type 2 market today, we know that approximately 50% of patients have a preference for an oral giving everything and see on the efficacy and the safety side. And similarly, on the obesity side, we know that we have approximately 25% of the patients in the US suffering from needle fear.

    非常感謝,克里斯。我認為這對 orforglipron 來說是一個重大機會。看看今天的第 2 型糖尿病市場,我們知道大約 50% 的患者傾向於選擇口服藥物,並且注重療效和安全性。同樣,在肥胖方面,我們知道美國大約有 25% 的患者患有針頭恐懼症。

  • So I think that positions us very nicely to be a first line incretin for both Type 2 and chronic weight management. The other benefits as well, I think with an oral here, we can scale and reach patients that is more or less impossible with all the injectables. So I think it provides a huge global opportunity for us. We will on and also from the manufacturing side, probably a significant benefit as well.

    因此,我認為這使我們非常適合成為 2 型和慢性體重管理的一線腸促胰島素。其他好處還有,我認為透過口服藥物,我們可以擴大規模並涵蓋患者,而這幾乎是所有註射劑都無法實現的。所以我認為這為我們提供了一個巨大的全球機會。從製造方面來看,我們也可能獲得顯著的利益。

  • So overall, I think tremendous opportunities here with orforglipron for Type 2 and obesity in the US and other markets where we have launched but also to scale globally to an extent we can't do with injectables.

    因此,總的來說,我認為 Orforglipron 在美國和我們已經推出產品的其他市場中,針對 2 型糖尿病和肥胖症有著巨大的發展機會,而且在全球範圍內的擴展也達到了注射劑無法達到的程度。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Maybe two quick adds there segments that we're thinking about actively. One, of course, we're doing the maintain studies which switch people from injectable to oral to maintain weight loss. That's a big unmet need in the market. People like the idea of stepping down and using less medicine. They're trying things on their own now and we'll have science-based solution using oral, which we think will be an attractive choice.

    也許我們正在積極考慮快速添加兩個部分。首先,當然,我們正在進行維持研究,讓人們從注射轉為口服,以維持減肥效果。這是市場上尚未滿足的龐大需求。人們喜歡減少用藥量的想法。他們現在正在自行嘗試,我們將透過口服獲得基於科學的解決方案,我們認為這是一個有吸引力的選擇。

  • That data is not in hand yet. We need to wait for that to prove that out. But I think that's an interesting segment that will probably grow quite large over time, Chris. The other one is reaching segments of the population that maybe have comorbid risk, maybe not comorbid disease, have overweight, but not obesity and don't need dramatic weight loss, but sustained lower body weight is an important factor in our long-term health. And we'll look at studies there.

    目前我們還沒有拿到這些數據。我們需要等待來證明這一點。但我認為這是一個有趣的部分,隨著時間的推移,它可能會變得相當大,克里斯。另一個目標是涵蓋可能有合併症風險、可能沒有共病、超重但不肥胖且不需要大幅減重的族群,但持續較低的體重是我們長期健康的重要因素。我們將研究那裡的情況。

  • I think the prior question was alluding to that in terms of indications that might be suitable for that space. So we have big ambitions here, and of course, we need to see the full data package come in on obesity, but a pretty exciting opportunity.

    我認為先前的問題暗示了可能適合該領域的跡象。因此,我們在這方面抱有遠大的抱負,當然,我們需要看到有關肥胖的完整數據包,但這是一個非常令人興奮的機會。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Okay. Thanks, Patrick. Thanks, Dave. Great. The next question, please.

    好的。謝謝,派崔克。謝謝,戴夫。偉大的。請回答下一個問題。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    摩根士丹利的特倫斯弗林。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Great, thanks for taking the question. Two part on orforglipron as well. I know you're obviously not going to comment directly on pricing at this point. But maybe just conceptually, if you're delivering the same profile as an injectable medicine would you decide to price lower, I guess, given you price to value. And then as you think about having a portfolio of weight loss medications potentially in 2026, does that give you additional leverage with some of these PBM discussions? Thank you.

    太好了,謝謝你回答這個問題。orforglipron 上也有兩個部分。我知道您現在顯然不會直接評論定價。但也許只是從概念上講,如果您提供與注射藥物相同的特性,考慮到價格與價值,您是否會決定降低價格?然後,當您考慮在 2026 年可能擁有一系列減肥藥物時,這是否會為您在某些 PBM 討論中提供額外的籌碼?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Okay. Going on the risk curve again, Terence, with a two-part question, but go to Patrik to weigh in the thoughts on the orfro pricing and then the portfolio implications as well.

    好的。特倫斯,再次談到風險曲線,我提出了一個由兩部分組成的問題,但請帕特里克權衡一下 orfro 定價的想法,以及投資組合的影響。

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • Thanks a lot, Terence. I think in terms of pricing, we normally don't comment on that until the time of launch. But I think truly having a portfolio in this space and as Steve shared earlier on oral that we actually could approach patients with a BMI above 27 lower BMIs to pat that probably will play as foundation with treatment of chronic weight management for quite some time to come. and potentially a triple agonist where you could target people with a BMI above 35. And so I think that gives us a position of strength in this marketplace.

    非常感謝,特倫斯。我認為就定價而言,我們通常不會在產品發布之前發表評論。但我認為,真正在這個領域擁有投資組合,正如史蒂夫早些時候在口頭上分享的那樣,我們實際上可以接觸體重指數高於 27 的患者,較低的體重指數可能會在未來相當長的一段時間內作為治療慢性體重管理的基礎。並且可能是一種三重激動劑,可以針對 BMI 超過 35 的人。因此我認為這使我們在這個市場上佔據了優勢地位。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Maybe just one like policy related add, like how do we think about pricing forward, especially in a category like this. The past was really about very high list prices and relatively deep discounts to leverage PBM access. And we've been very vocal about trying to move away from that past. Basically, they have more transparent, closer pricing between list and that -- maybe important to say that based on this morning's news as well.

    也許只是一個與政策相關的補充,例如我們如何考慮未來的定價,特別是在這樣的類別中。過去實際上是透過非常高的標價和相對較大的折扣來利用 PBM 存取權限。我們一直大聲呼籲要擺脫過去。基本上,他們的定價更加透明,與標價的定價更加接近——根據今天早上的新聞,這麼說也許很重要。

  • So we price that out at a discount to the competitor a meaningful discount on list price with the idea of trying to squeeze those two numbers together, we'd like to continue that progress so that patients and payers have a more similar basis for cost sharing and that cost. I think that's a better way forward. So just as Patrick and the team work on pricing strategies, et cetera, now that in the background, we're trying to push these two numbers together over time, reduce gross to net spreads have less rebate flow into the channel and more transparent overall pricing.

    因此,我們以比競爭對手更低的折扣價定價,即在標價上給予一個有意義的折扣,目的是將這兩個數字擠在一起,我們希望繼續這一進展,以便患者和付款人有更相似的成本分攤基礎和成本。我認為這是更好的前進方式。因此,正如帕特里克和他的團隊致力於定價策略等等一樣,現在在後台,我們正試圖隨著時間的推移將這兩個數字推到一起,減少毛利與淨利差,減少流入渠道的回扣,提高整體定價的透明度。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thank you, Dave. Thank you, Patrick. Next question, please.

    偉大的。謝謝你,戴夫。謝謝你,派崔克。請回答下一個問題。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    富國銀行的 Mohit Bansal。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Great, thank you very much for taking my question. I think going back to the CBS announcement this morning. There are two ways to look at it. I mean one could be, which obviously the stock reaction is like that, it seems like, I mean, Zepbound vs Wegovy kind of price war? Or the other way could be looking at CBS comments, it seems like a lot of employers did not opt in and CBS is finding a way to actually provide affordable access to this medicine. How do you view this development?

    太好了,非常感謝您回答我的問題。我想回顧一下今天早上哥倫比亞廣播公司的公告。有兩種方式可以看待它。我的意思是,顯然股票反應是這樣的,看起來就像 Zepbound 與 Wegovy 之間的價格戰?或者另一種方式是看看哥倫比亞廣播公司 (CBS) 的評論,似乎很多雇主並沒有選擇加入,而哥倫比亞廣播公司正在尋找一種方法來真正提供負擔得起的這種藥物。您如何看待這項發展?

  • And in longer term, I think is it better versus GLP-1 or is it a GLP-1 versus access situation you see this is going to evolve over a couple of years?

    從長遠來看,我認為它比 GLP-1 更好還是 GLP-1 與訪問情況相比,您認為這將在幾年內發展?

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks for the question, Mohit. I think, Dave, do you want to elaborate on some of the earlier comments about the CDS?

    謝謝你的提問,Mohit。戴夫,我想你想詳細闡述之前關於 CDS 的一些評論嗎?

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • I mean I think those are good questions to ask Novo and CBS, really. Just pointing out that the book of business we're talking about is smaller employers who tend to take the template and formulary, the opt-in rates already are low. So it is possible that depending on what net price that CBS is going to offer those clients so you get more opt in.

    我的意思是,我認為這些都是向 Novo 和 CBS 提出的好問題。只是指出,我們所討論的業務簿是傾向於採用模板和處方集的小型雇主,選擇加入率已經很低了。因此,這可能取決於 CBS 為這些客戶提供的淨價,以便您獲得更多選擇。

  • I think that's a net good thing overall because what we see despite the press is when employers opt in, they tend to not opt out. Employees like to be on these medicines, and there was a big study yesterday, you may have seen from Aon which looked at real-world data, which is very compelling.

    我認為總體來說這是一件好事,因為儘管媒體報導如此,但我們看到的是,當雇主選擇加入時,他們往往不會選擇退出。員工們喜歡服用這些藥物,昨天有一項大型研究,你可能已經看到怡安公司研究了真實世界的數據,這非常引人注目。

  • And within two years, there's ROI, a 40% reduction in MACE events in the real world, et cetera. So that could be good as you're saying. On the other hand, I guess we're focused on innovation and differentiation. We see kind of a mega category here that will have many different choices and solutions.

    並且在兩年內,就有了投資回報,現實世界中的 MACE 事件減少了 40%,等等。所以正如你所說,這可能很好。另一方面,我想我們專注於創新和差異化。我們在這裡看到一個超級類別,它將有許多不同的選擇和解決方案。

  • And it seems like the wrong idea to reduce choice, maybe there's patients who are taking Zepbound in one of these formularies and as of July 1, they won't have that choice, I think they'll be quite upset about that. And we'll see how the market reacts and how much share it gets moved ultimately. But as I said, our preference is to expand access, not reduce it.

    減少選擇似乎是錯誤的想法,也許有些患者正在服用這些處方集中的 Zepbound,但從 7 月 1 日起,他們將不再有這種選擇,我想他們會對此感到非常沮喪。我們將觀察市場如何反應以及最終市場份額將有多少變化。但正如我所說,我們傾向於擴大訪問範圍,而不是減少訪問範圍。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Dave. Next caller, please.

    謝謝,戴夫。請下一位來電者。

  • Operator

    Operator

  • Alex Hammond, Wolfe.

    亞歷克斯·哈蒙德,沃爾夫。

  • Alexandria Hammond - Analyst

    Alexandria Hammond - Analyst

  • Thanks for taking the question. Just one quick one on TRAILBLAZER-ALZ 3. So during the 4Q call, Anne mentioned that the team is closely watching the preclinical trial, and the study will read out when the target number of progression events were accrued. Can you update us as to where we are from that event point of view and remind us of what a successful trial looks like? Thank you.

    感謝您回答這個問題。關於 TRAILBLAZER-ALZ 3 僅簡單介紹一下。因此,在第四季度電話會議期間,安妮提到團隊正在密切關注臨床前試驗,研究將在達到目標進展事件數量時讀出結果。您能否從該事件的角度告訴我們目前的情況並提醒我們成功的試驗是什麼樣的?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Alex. We'll go to Anne for the question on -- the welcome question on the Alzheimer's portfolio.

    偉大的。謝謝,亞歷克斯。我們將請安妮回答有關阿茲海默症投資組合的歡迎問題。

  • Anne White - Executive Vice President, President - Lilly Neuroscience

    Anne White - Executive Vice President, President - Lilly Neuroscience

  • Yes. Thanks so much for a question on Alzheimer's. And as we mentioned in the past, we have completed enrollment in the TB-III study. And as you said, it's an event-based study. So the time line for the readout is driven by this.

    是的。非常感謝您提出有關阿茲海默症的問題。正如我們過去所提到的,我們已經完成了 TB-III 研究的招募。正如您所說,這是一項基於事件的研究。因此,讀數的時間線由此驅動。

  • And although our clinicaltrials.gov lists the date in 2027, we believe it could be earlier than that. So we're looking forward to that. Now these are patients who have elevated levels of amyloid but no detectable symptoms, and our goal is to significantly reduce the risk that people ever experience the symptoms of Alzheimer's disease. So that's the goal of the study. The actual endpoint is time to event of clinical progression, and we measure that by the CDR global score.

    儘管我們的 clinicaltrials.gov 列出的日期是 2027 年,但我們認為可能更早。所以我們對此充滿期待。現在這些患者的澱粉樣蛋白水平升高但沒有可檢測到的症狀,我們的目標是顯著降低人們出現阿茲海默症症狀的風險。這就是研究的目標。實際終點是臨床進展事件發生的時間,我們以 CDR 總體評分來衡量。

  • So really preventing people from moving to the symptomatic stage, which is the stage at which the greatest impact is happening. So what we saw in TB-II obviously, got us very excited about the potential outcome here with the fact that patients earliest in disease and early symptomatic did so well and had such a significant slowing of progression 60%. So we look forward to sharing more as the events occur. And again, we'll share more timing when we have these events reached.

    因此,真正阻止人們進入症狀階段,這是影響最大的階段。因此,我們在 TB-II 中看到的情況顯然讓我們對這裡的潛在結果感到非常興奮,因為發病最早、症狀最早的患者恢復得非常好,病情進展顯著減緩了 60%。因此,我們期待在事件發生時分享更多內容。再次強調,當我們舉辦這些活動時,我們會分享更多時間安排。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Anne. And next question, please.

    偉大的。謝謝,安妮。請問下一個問題。

  • Operator

    Operator

  • Seamus Fernandez, Guggenheim

    謝默斯費爾南德斯,古根漢美術館

  • Seamus Fernandez - Analyst

    Seamus Fernandez - Analyst

  • Thanks for the question. So I'll go with another non-obesity question. How is Ebglyss tracking against your ambition of it being a best-in-class launch? Is your vision for peak sales in line with consensus sales of $2 billion? Or do you see an opportunity materially higher than that?

    謝謝你的提問。因此我將討論另一個與肥胖無關的問題。Ebglyss 與您打造一流產品的雄心相比如何?您對銷售高峰的預期是否與 20 億美元的普遍預期銷售一致?或者您看到了比這更高得多的機會?

  • And if not, is the barrier related to Sanofi's claimed rebate wall or something else like the breadth of the label or perceived efficacy differentiation? Thanks so much.

    如果不是,那麼障礙是否與賽諾菲聲稱的折扣壁壘有關,或者與標籤的廣度或感知到的功效差異等其他因素有關?非常感謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Seamus. We'll go to Dan to talk about the Ebglyss launch dynamics and some goals for the brand.

    偉大的。謝謝,西莫斯。我們將與丹討論 Ebglyss 的發布動態以及該品牌的一些目標。

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Thanks, Seamus. We certainly do have high aspirations for Ebglyss. It's a great medicine. We saw amazing data in our clinical trials. I think this prepared us well to take on the market leader in atopic derm, which is a large and growing market. And in the early months of launch, we've seen good uptake, as you can see reflected in the numbers.

    謝謝,西莫斯。我們確實對 Ebglyss 寄予厚望。這是一種很好的藥。我們在臨床試驗中看到了驚人的數據。我認為這使我們做好了充分的準備,可以成為特應性皮膚病市場的領導者,這是一個龐大且不斷成長的市場。在推出後的最初幾個月,我們已經看到了良好的反應,正如您在數據中看到的那樣。

  • And I think probably most telling is what we're seeing and hearing from physicians initially, I think in any launch, people try their most severe patients, people who might have failed other therapies. And when they see good responses there, they move it into the first-line setting. That's exactly the motion we're seeing from physicians.

    我認為最能說明問題的是我們最初從醫生那裡看到和聽到的情況,我認為在任何發布中,人們都會嘗試治療最嚴重的患者,那些可能對其他療法失敗的患者。當他們看到良好的反應時,他們就會將其移至一線設定。這正是我們從醫生身上看到的動向。

  • They're happy with the results they're getting and they're using it more and more. A lot of work to do, and you point out the heavy competitive dynamics, but I like the asset I have. In terms of the rebates and coverage, I think as Lucas said, we're seeing a growing coverage here in the United States, and I think we'll overcome any issues there without trouble. So we look forward to broad access and continued accelerating uptake.

    他們對所獲得的結果非常滿意,並且越來越多地使用它。有很多工作要做,你也指出了激烈的競爭態勢,但我喜歡我擁有的資產。至於回扣和保險範圍,我認為正如盧卡斯所說,我們看到美國境內的保險範圍正在擴大,而且我認為我們可以毫無困難地解決那裡的任何問題。因此,我們期待廣泛的應用和持續加速的吸收。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thank you, Dan. Next caller please.

    偉大的。謝謝你,丹。請下一位來電。

  • Operator

    Operator

  • Tim Anderson, Bank of America.

    美國銀行的蒂姆·安德森。

  • Timothy Anderson - Analyst

    Timothy Anderson - Analyst

  • Thank you. A question on kind of going back to formulary positioning in obesity. So I know you don't want to play the one of one formulary game but it's still something that might occur anyway because Novo is losing share to you and price is really the only lever they can pull at the moment and some payers will look at one of one as a way to manage spend.

    謝謝。關於肥胖症處方定位的問題。所以我知道你不想玩一對一的處方遊戲,但這仍有可能發生,因為 Novo 正在向你失去市場份額,而價格實際上是他們目前唯一可以利用的槓桿,一些付款人會將一對一視為管理支出的一種方式。

  • I know that some states have already taken that approach, now we're seeing CBS. So really, the question is I guess, of covered lives today, what percent of payers already are having this one of one approach and just again, your view for how this is going to evolve going forward, whether you like it or not?

    我知道一些州已經採取了這種做法,現在我們看到的是 CBS。所以,我猜真正的問題是,在當今受保的人中,有多少百分比的付款人已經採用這種一對一的方法,再說一遍,無論您是否喜歡,您對於這種做法未來將如何發展有何看法?

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Tim. For the next question on CBS, we'll go to Patrick.

    謝謝,蒂姆。關於 CBS 的下一個問題,我們將請派崔克回答。

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • Yeah, thank you very much, Tim. One-on-one is quite rare in the marketplace today when it comes to obesity. And as Dave said earlier, we deal with contract negotiations all the time, and we are not entirely surprised with the announcement this morning, taking into account Zepbound strong performance. For us, we will just continue to execute as strongly as we can. And I think we have a tremendous momentum in the marketplace with a net switch, but it's quite significant to set down in the marketplace.

    是的,非常感謝,提姆。如今,在肥胖問題上,一對一的諮詢在市場上相當罕見。正如戴夫之前所說,我們一直在處理合約談判,考慮到 Zepbound 的強勁表​​現,我們對今天早上宣布的消息並不完全感到驚訝。對我們來說,我們將繼續盡最大努力去執行。我認為我們在網路轉換市場上擁有巨大的發展勢頭,但在市場上站穩腳跟具有重要意義。

  • We will continue growth efforts across the PBMs, Medicaid and North America, and of course, our self-pay effort with buyers as well.

    我們將繼續努力在 PBM、醫療補助和北美地區成長,當然,我們也會努力為買家提供自付費用。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thank you, Patrick. Next question, please.

    謝謝你,派崔克。請回答下一個問題。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    埃文·塞格曼 (Evan Seigerman),BMO 資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Hi guys, thank you so much for taking my question. I wanted to touch on tirzepatide (inaudible). The update was a bit surprising today. Can you provide some additional detail on what FDA wants to see in regard to additional data? And what you didn't have from the SUMMIT trial that was to demonstrate the clear enough benefit? Thank you.

    大家好,非常感謝你們回答我的問題。我想談談 tirzepatide(聽不清楚)。今天的更新有點令人驚訝。您能否提供一些有關 FDA 希望看到的額外數據的更多細節?那麼,SUMMIT 試驗中您沒有發現什麼能夠證明其足夠明顯的好處呢?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Yeah. Thanks, Evan. We'll go to Dan for the question on the heart failure dynamics

    是的。謝謝,埃文。我們將向丹詢問有關心力衰竭動力學的問題

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Yeah, thanks, Evan. It's probably obvious to you is that, that was a study with a really strong and profound benefit for patients. So we're excited about the opportunity to help patients with that. I think from the FDA perspective, they want multiple trials to support this indication. And I think that's probably where we ended it. It's possible we could get additional data from other trials to support the resubmission here.

    是的,謝謝,埃文。您可能已經清楚,這是一項對患者俱有真正巨大而深遠益處的研究。因此,我們很高興有機會幫助患者。我認為從 FDA 的角度來看,他們希望進行多次試驗來支持這種適應症。我想這可能就是我們結束這件事的地方了。我們有可能從其他試驗中獲取更多數據來支持此處的重新提交。

  • On the other hand, just remember that all of the patients in this trial and the syndication are already covered under the obesity indication. So it's not a new population to treat. It's rather a new benefit for people that might already be widely understood to doctors today. So it's a bit unfortunate we're in this position, and it could have a bit of a curtailing effect on investment in HPE, which is a pretty serious unmet medical need. So I'm sorry to see that.

    另一方面,請記住,本次試驗和聯合試驗中的所有患者都已符合肥胖症的指徵。因此,這並不是一個需要治療的新人。這對人們來說是一個新的好處,而今天的醫生可能已經廣泛了解它了。因此,我們處於這種境地有點不幸,這可能會對 HPE 的投資產生一些抑製作用,而 HPE 是一個相當嚴重的未滿足的醫療需求。我很遺憾看到這一幕。

  • But it's kind of hard to think of the incentive for doing large outcome trials in this population that's already covered under an existing indication and the benefits are well understood.

    但是,很難想像在這個已經受到現有適應症覆蓋且益處眾所周知的人群中進行大規模結果試驗的動機。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks. Dan. Next question.

    偉大的。謝謝。擔。下一個問題。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    德意志銀行的詹姆斯辛 (James Shin)。

  • James Shin - Analyst

    James Shin - Analyst

  • Hey, good morning, guys. Thank you for the question. Maybe one for Lucas. I know revenue guidance was maintained, but is the mid-to-high single-digit price headwinds still intact following the CVS formulary decision on Zepbound and also given the movement in FX? Thank you.

    嘿,大家早安。謝謝你的提問。也許給盧卡斯一個。我知道收入指引得到了維持,但在 CVS 對 Zepbound 做出處方決定並考慮到外匯走勢之後,中高個位數的價格阻力是否仍然存在?謝謝。

  • Lucas Montarce - Executive Vice President and Chief Financial Officer

    Lucas Montarce - Executive Vice President and Chief Financial Officer

  • Yeah, thank you for the question, James. Thank you for the question, James. Maybe just jumping into it right away. As you've heard, we are reaffirming our guide for the full year that the midpoint continues to be in that 32% range for the year. We are off to a good start with the strong growth that we see in the first quarter.

    是的,謝謝你的提問,詹姆斯。謝謝你的提問,詹姆斯。也許直接就跳進去吧。正如您所聽到的,我們重申全年指引,即全年中點將繼續保持在 32% 的範圍內。我們第一季實現了強勁成長,這是一個好的開始。

  • To your question about the price, yes, again, I mentioned last time, and I reaffirm it now again, that mid-to-high single-digit price erosion. We've seen that in the first quarter, by the way, minus 6% in price. So it's very consistent with what I shared in the last earnings call. So overall, I think that, that perspective has not changed, both in terms of the guide and our expectations on price for the year. Maybe just again to provide a little bit more perspective on how things evolve and how we think about the guide.

    對於您關於價格的問題,是的,我上次提到過,現在我再次重申,價格將呈現中高個位數的下降。順便說一下,我們在第一季就看到價格下跌了 6%。這與我在上次財報電話會議上分享的內容非常一致。所以總的來說,我認為,無論是從指南還是對今年價格的預期來看,這種觀點都沒有改變。也許只是再次提供一些關於事情如何發展以及我們如何看待指南的觀點。

  • There are always dynamics taking place during the year, as you can imagine and we factor those ones as part of our forecasting process. So we -- as Patrik alluded, we are not surprised with this. And again, we will continue to navigate. We feel strongly about the update that we are seeing nowadays, and we will continue to navigate through this throughout the year.

    正如您所想像的,一年中總會有各種動態發生,我們將這些動態作為預測過程的一部分。因此,正如派崔克所暗示的,我們對此並不感到驚訝。我們將繼續前進。我們對現在看到的更新有強烈的感受,我們將在全年繼續探索這項更新。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thank you, Lucas. Thanks for the question. Next question, please.

    偉大的。謝謝你,盧卡斯。謝謝你的提問。請回答下一個問題。

  • Operator

    Operator

  • Umer Raffat, Evercore.

    烏默·拉法特(Umer Raffat),Evercore。

  • Umer Raffat - Analyst

    Umer Raffat - Analyst

  • Morning guys. Thanks for taking my question and congrats on recent orforglipron updates. I had a question -- a two-part question on orfor safety. First, I recall you mentioned no hepatic safety signal was observed and no highs law. Could you confirm there was no numerical imbalance on ALT above 5 times? And on diarrhea, I recall it was in the low to mid-20s across the second highest and highest dose.

    大家早安。感謝您回答我的問題,並祝賀 orforglipron 最近的更新。我有一個問題——關於安全性的一個由兩部分組成的問題。首先,我記得您提到沒有觀察到肝臟安全訊號,也沒有高點定律。您能否確認 ALT 上沒有 5 倍以上的數值不平衡?至於腹瀉,我記得第二高劑量和最高劑量的療效都在 20 多歲左右。

  • How should we think about that heading into the obesity trial, especially with longer duration? Thank you very much.

    我們該如何看待肥胖症試驗,尤其是持續時間較長的試驗?非常感謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks so much for the question on the state profile for orfor.

    非常感謝您提出有關 orfor 州概況的問題。

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Okay, thanks. Those are very specific questions, which I may not precisely know the answer to, honestly. But as far as the overall liver safety profile, including kind of mean changes and excursions from the mean we didn't see anything of concern here, and it looked very similar to placebo. So I think we feel confident that additional data readouts coming, of course, but so far, so good. I think with respect to rates of diarrhea, you're pointing out that they were a bit higher in this study than we've seen in previous studies.

    好的,謝謝。這些都是非常具體的問題,老實說,我可能不知道確切的答案。但就整體肝臟安全性而言,包括平均變化和偏離平均值的偏差,我們沒有發現任何值得擔憂的情況,它看起來與安慰劑非常相似。因此,我認為我們有信心將會有更多數據讀數,當然,到目前為止,一切都很好。我認為,就腹瀉的發生率而言,您指出這項研究中的腹瀉發生率比我們在先前的研究中看到的要高一些。

  • They were also higher in the placebo rate. I think we might need to move to an understanding of diarrhea rates as a sort of a ratio of drug to placebo because they could be pretty variable depending on the country that you enrolled the trial, and we saw that effect in this study with some countries having very high diarrhea rates in placebo and drug and also the way that's ascertained by the investigators.

    他們的安慰劑使用率也較高。我認為我們可能需要將腹瀉率理解為藥物與安慰劑的比例,因為根據參與試驗的國家不同,腹瀉率可能會有很大差異,我們在本研究中看到了這種影響,一些國家在安慰劑和藥物治療中的腹瀉率非常高,這也是研究人員確定的方式。

  • So I didn't see anything of concern there, but I do need our trials that probably across the Lilly to have slightly higher diarrhea rates than others. But let's see what we see in the obesity rate. That's not the main focus here. Probably the more telling indicator of tolerability is going to be discontinuations due to adverse events, that's probably matters the most in the real world.

    所以我沒有看到任何值得擔心的事情,但我確實需要我們的試驗,該試驗可能在禮來公司範圍內的腹瀉發生率比其他試驗略高。但讓我們看看肥胖率的情況。這不是這裡關注的重點。可能更能說明耐受性的指標是由於不良事件而停藥,這在現實世界中可能是最重要的。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thank you, Dan. Thanks for the question. Next question, please.

    偉大的。謝謝你,丹。謝謝你的提問。請回答下一個問題。

  • Operator

    Operator

  • Steve Scala, TD Cowen

    史蒂夫·斯卡拉(Steve Scala),TD Cowen

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Oh, thank you very much. My recollection is that Lilly used aggressive formulary positioning as a lever with touts against other IL-17 competitors and, therefore, reduce choice. Would you refresh our memories on what that did for touts in terms of share and incremental sales? And if you're willing to, at what discount? And how can that experience inform us on the outlook for Zepbound we go on the CVS formulary? Thank you.

    噢,非常感謝。我記得禮來公司利用積極的處方定位作為槓桿,與其他 IL-17 競爭對手競爭,從而減少選擇。您能否讓我們回憶一下,這對黃牛在市場佔有率和增量銷售方面有何影響?如果您願意的話,折扣是多少?那麼,這些經驗如何讓我們了解 CVS 處方集上 Zepbound 的前景呢?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Steve. Dave, we'll go to you for the history of environment.

    偉大的。謝謝,史蒂夫。戴夫,我們將向您請教環境史。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • So 4 score and seven years ago.

    那是 487 年前的事了。

  • No, we launched talks almost a decade ago. I have a different recollection. I was in charge of it at the time. Actually, we had a situation where we are the follower and what we try to do is go from one of one in a new category two of two. And that's what I think we more or less achieved over the course of the first three or four years of the brand.

    不,我們大約十年前就開始談判了。我有不同的記憶。當時我負責此事。實際上,我們處於一種跟隨者的狀態,我們試圖做的是從一到二進入一個新的類別二到二。我認為這就是我們在品牌成立後的前三、四年或多或少取得的成就。

  • Of course, things have changed since then with IL-23s and now a third IL-17 entering and you do see one of ones, but I guess maybe a point to raise here is, that kind of payer behavior is more common in the pharma industry, when you have more than two players and when you have product profiles that are clinically kind of close to each other.

    當然,從那時起,隨著 IL-23 和現在第三種 IL-17 的進入,情況發生了變化,你確實看到了其中一種,但我想這裡要提出的一點是,這種付款人行為在製藥行業更為常見,當你有兩個以上的參與者並且當你的產品概況在臨床上彼此接近時。

  • Just pointing out in the obesity space, it's -- neither of those things are true. And it will be interesting to see how this experiment works. We have more differentiation coming. So I think there'll be more choice needed in the marketplace, not less. It's really never been our strategy in a category to use the payer channel to drive share exclusively even when we had big advantages on clinical profile.

    只是指出在肥胖領域,這兩種情況都不正確。看看這個實驗如何進行將會很有趣。我們將會有更多的差異化。因此我認為市場上需要更多的選擇,而不是更少。即使我們在臨床概況方面擁有巨大優勢,我們從來沒有採取過專門利用付款人管道來推動市場份額的策略。

  • I mean a majority is an example of that where we always sought to have multiple choices in that class. So different memory than yours, Steve, although you've been doing this a long time as well. And that doesn't mean we didn't have some situations that were one-on-one for talls but it wasn't our preferred position. And frequently, we didn't offer different rates to get there. So that's also -- all that's true now.

    我的意思是,大多數就是一個例子,我們總是尋求在那個階層有多種選擇。史蒂夫,這與你的記憶非常不同,儘管你也已經這樣做了很長時間。這並不意味著我們沒有遇到一些高個子球員一對一的情況,但這不是我們喜歡的位置。而且通常情況下,我們不會提供不同的到達價格。所以這也是──現在所有都是事實。

  • We, as a company position want more choice and particularly where innovation is flourishing, and we have a lot of it coming, it wouldn't be in our interest.

    作為一家公司,我們希望擁有更多選擇,尤其是在創新蓬勃發展、大量創新湧現的背景下,這不符合我們的利益。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thank you, Dave. Next question, please.

    偉大的。謝謝你,戴夫。請回答下一個問題。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    考特尼·布林,伯恩斯坦。

  • Courtney Breen - Analyst

    Courtney Breen - Analyst

  • Hi everyone, thanks for the question. Perhaps just following on from Steve's question as well. Can you clarify for us because I think a number of investors are concerned and obviously, we see that in the share price today, how many current patients on Zepbound are being covered by CVS Caremark today?

    大家好,感謝您的提問。或許這也只是對史蒂夫問題的延續。您能否為我們澄清一下,因為我認為許多投資者都很擔心,而且顯然,我們從今天的股價中看到,今天有多少 Zepbound 的現有患者正在接受 CVS Caremark 的承保?

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Okay. Thanks for the question, Courtney. Maybe give some color on the rough magnitude, Patrik, on the CVS Zepbound dynamics.

    好的。謝謝你的提問,考特尼。帕特里克,也許可以給出一些關於 CVS Zepbound 動態的粗略幅度的資訊。

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • Yeah, you're not, I don't have a specific number of lives to share today. But I think when you look at it so back to it's not the entire CVS account. We're talking about the subset of plans that Dave shared earlier. And we also need to understand what is the level of employer opt in those plans.

    是的,你不是,我今天沒有具體的數量可以分享。但我認為當你回頭看它時,它並不是整個 CVS 帳戶。我們正在討論 Dave 之前分享的計劃子集。我們還需要了解雇主選擇這些計劃的程度。

  • And we believe it's not on the high end. So I think that's probably the guidance we can provide today. And I think we will just continue our efforts to drive increased employer opt-in across other plants and segments. But that's the number I -- that's the only thing I can share today.

    我們認為它並不屬於高端。所以我認為這可能是我們今天可以提供的指導。我認為我們將繼續努力,推動其他工廠和部門的雇主更多地選擇加入。但這是我今天唯一能分享的數字。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thank you, Patrick. Next question, please.

    偉大的。謝謝你,派崔克。請回答下一個問題。

  • Operator

    Operator

  • David Risinger, Leerink Partners

    Leerink Partners 的 David Risinger

  • David Risinger - Analyst

    David Risinger - Analyst

  • Yes, thanks very much. So I'm hoping that you can comment, Dave, on discussions with the Trump administration on tariffs outside of the 232 investigation. So the driver of my question is that the countries of origin for Lilly's drugs IP and API are obviously not in countries that represent national security threats. And I'm curious about the discussions to satisfy the Trump administration's interest in having drug companies record more profits in the United States and generate more tax revenue in the United States? Thank you.

    是的,非常感謝。所以我希望你能就 232 調查之外與川普政府就關稅進行的討論發表評論,戴夫。所以我的問題的驅動力是,禮來公司的藥物智慧財產權和原料藥的原產國顯然不在對國家安全構成威脅的國家。我很好奇,關於滿足川普政府利益的討論是否旨在讓製藥公司在美國獲得更多利潤並在美國產生更多稅收?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thank you, Dave. Dave, go ahead.

    謝謝你,戴夫。戴夫,說吧。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • I mean you're correct in pointing out that Section 232 mechanism is a national security mechanism, and that's where the pharma review sits today. Separately, there is an agenda item in the administration to repatriate supply chain and one we support. And then thirdly, there's a question of raising revenue while they're going through a reconciliation process and so far.

    我的意思是,您正確地指出第 232 條機制是一種國家安全機制,而這正是當今製藥審查的依據。另外,政府中有一項關於遣返供應鏈的議程,我們對此表示支持。第三,在他們進行和解過程的同時,還有一個增加收入的問題。

  • So just on those three things. The 232 review, I think, has merit in the sense that if we look at what are really a lot of commonly used generic medications, some of which invented by Lilly long ago or other innovative companies have moved toward offshore sources, single-source sources and potentially in competing countries where you can imagine a future conflict and a potential problem.

    就這三件事來說。我認為,232 審查是有價值的,因為如果我們看一下真正常用的仿製藥,你會發現其中一些是禮來公司或其他創新公司很久以前發明的,並且已經轉向了海外來源、單一來源以及潛在的競爭國家,你可以想像未來的衝突和潛在問題。

  • We see that, too. I think the branded industry would like to help with that problem if we could. Fundamentally, it's kind of a market mechanism problem, where the -- there's no real good pricing available. So there's not going to be an onshore presence until there is.

    我們也看到了這一點。我認為,如果可以的話,品牌產業願意幫助解決這個問題。從根本上來說,這是一種市場機制問題,即沒有真正好的定價。因此,除非有陸上存在,否則我們不會這麼做。

  • But in the case of emergency, maybe we could work with them. I think there's a big question of whether tariffing that would do anything to move the supply chain. And maybe that's the subject of that review. And we would hope the 232 review would be kind of cabin to that question. Secondly, is the trade imbalance broader thing.

    但在緊急情況下,也許我們可以與他們合作。我認為一個很大的問題是,徵收關稅是否會對供應鏈產生影響。這也許就是那篇評論的主題。我們希望 232 審查能夠解答這個問題。其次,貿易不均衡是一個更廣泛的問題。

  • And as you're pointing out, so we have a mixed source, US and non-US, but most of our non-US is Irish origin, and we're in the process, we made a decision four years ago with the Board to move away from just a pure efficiency, whether it be tax efficiency or cost of goods efficiency and move to a more of a resilient position. We've been at this a little while, and we'll continue to do that. And so that will rebalance naturally our sourcing a lot more choices.

    正如您所指出的,我們的來源是混合的,既有來自美國的客戶,也有來自美國以外的客戶,但大多數非美國客戶都來自愛爾蘭。我們正在進行這個過程,四年前,我們與董事會做出了一項決定,不再僅僅關注效率,無論是稅收效率還是商品成本效率,而是轉向更具彈性的立場。我們已經這樣做了一段時間,並將繼續這樣做。這樣一來,我們自然就會重新平衡採購,獲得更多選擇。

  • So I think tariffing that could have a transient effect for Lilly, but probably not a long-term one. We think the real answer there, as I said earlier, is to reduce the gap that led to that problem to begin with, which is really an income tax situation. And when the US was at 35 in Ireland was a whatever, 15. So I think tax reform is key to that, and we'll fix that problem for the long term.

    因此我認為徵收關稅可能會對禮來公司產生暫時的影響,但可能不會產生長期影響。我們認為,正如我之前所說,真正的答案是減少導致該問題的差距,這實際上是一個所得稅問題。當美國的死亡率為 35 時,愛爾蘭的死亡率僅為 15。所以我認為稅制改革是解決這個問題的關鍵,我們將長期解決這個問題。

  • Within Lilly, we've made investments to sort of contain that anyway. The raising revenue in general is a separate point and one we point out that our industry pays a disproportionate amount of income tax. And then actually, because in the 2017 Tax Cut Jobs Act, there are provisions for a minimum global tax basically so that we already pay tax on foreign-sourced income. So that really doesn't change whether we move it back to US or not.

    無論如何,在禮來公司內部,我們已經進行了投資來控制這種情況。整體而言,增加收入是另一個問題,我們要指出的是,我們的行業繳納的所得稅金額過高。實際上,由於 2017 年減稅就業法案規定了最低全球稅,因此我們已經對外國來源收入納稅。所以無論我們是否將其移回美國,這實際上都沒有改變。

  • What that does is it has an effect of raising income tax in the third countries, which it actually has done over the last seven years. So I think we're well positioned within the mix of companies. I think these issues are complicated and hard to reduce the sound bites 232 has substance. I think the trend on for the industry and certainly for Lilly of re-domesticating is well underway. And we hope we don't have to get into a tariff discussion. Hopefully, we pass the tax bill and this can normalize.

    結果是提高了第三國的所得稅,事實上,過去七年來它已經這樣做了。所以我認為我們在公司組合中處於有利地位。我認為這些問題很複雜,很難減少232的聲音片段的實質內容。我認為,對於整個行業,尤其是對於禮來公司來說,重新馴化的趨勢正在順利進行中。我們希望我們不必陷入關稅討論。希望我們能夠通過稅收法案,讓這一切正常化。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Okay, thank you, Dave. Next question please.

    好的,謝謝你,戴夫。請問下一個問題。

  • Operator

    Operator

  • Kerry Holford, Berenberg.

    凱莉·霍爾福德,貝倫貝格。

  • Kerry Holford - Analyst

    Kerry Holford - Analyst

  • Apologies. Thank you. A question on the cash pay approach here in the US is about -- CVS has announced that its pharmacists will stock the would go the cashpay pens. So my question is when does that whether Zepbound are available in the US in any pharmacy chain today? And given your enthusiasm for that opportunity cash pay in general, I'm interested in whether you're considering additional channels outside your online LillyDirect portal, would that be an opportunity for you as well within the pharmacy chains in the US?

    抱歉。謝謝。關於美國現金支付方式的一個問題是——CVS 宣布其藥劑師將儲備現金支付筆。所以我的問題是,Zepbound 何時能在美國任何一家連鎖藥局買到?鑑於您對現金支付機會的熱情,我感興趣的是,您是否正在考慮在線 LillyDirect 門戶之外的其他渠道,這對您來說是否也是在美國藥房連鎖店中的一個機會?

  • And then -- and a related question, do you ultimately to ever offer the Zepbound pens via the cash pay route? Or do you intend to keep that separation? Thank you.

    然後——還有一個相關的問題,您最終是否會透過現金支付方式提供 Zepbound 筆?或者您打算保持這種分離?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Kerry. Related question, again, getting close to the line there. But Patrik, do you want to take the question on the vials, the cash pay distribution and if we would ever think of other formulations?

    謝謝,克里。相關問題,再次接近底線。但是派崔克,你想回答有關小瓶子、現金支付分配的問題嗎?以及我們是否會考慮其他方案?

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • I think we're very pleased with the performance in our self-pay segment. And if we look just on Q1, we had revenues above $200 million and 25% of the [MBR] for Zepbound are initiated in Q1 through self-pay and 17% of the entire market NBRx in self-pay. And I think we stated from the beginning when we launched LillyDirect that we did it to remove friction for patients and that we will continue to add products, add services and other components. I think you should expect more to count LillyDirect. I don't have anything to announce today.

    我認為我們對自付費用部分的表現非常滿意。如果我們只看第一季度,我們的營收超過 2 億美元,Zepbound 的 25% [MBR] 是在第一季透過自付方式發起的,而整個市場 NBRx 的 17% 是透過自付方式發起的。我認為,從我們推出 LillyDirect 之初我們就表示,我們這樣做是為了消除患者的摩擦,並且我們將繼續增加產品、增加服務和其他組件。我認為您應該對 LillyDirect 抱有更多期待。我今天沒有什麼要宣布的。

  • But I would just emphasize that the price change that we announced earlier this year and the launch of high-dose vials has significantly contributed to an even further acceleration of the market growth. So I think we are doing something here to really enable more patients to access those medications at a relatively competitive price.

    但我只想強調的是,我們今年稍早宣布的價格變化和高劑量小瓶的推出極大地促進了市場成長的進一步加速。所以我認為我們在這裡採取的措施是真正讓更多的患者能夠以相對有競爭力的價格獲得這些藥物。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thank you, Patrick. Next question.

    謝謝你,派崔克。下一個問題。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    Akash Tewari,傑富瑞。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Hey, thanks so much. It seems like your team is really going after the 75% of Americans who are both overweight and obese. Would long-term net pricing have to approach insulin levels for that to become a reality? Additionally, the Street models long-term margins going above 50%, while your team has been insistent that, that 40% to 45% range is really sustainable. How much of that delta is really us misunderstanding your volume over price approach to GLP-1s long term?

    嘿,非常感謝。看起來您的團隊確實在關注 75% 的超重和肥胖的美國人。長期淨定價是否必須接近胰島素水平才能成為現實?此外,華爾街預測長期利潤率將超過 50%,而您的團隊一直堅持 40% 至 45% 的範圍才是真正可持續的。這個差異有多少是因為我們誤解了你們對 GLP-1 長期的量價策略?

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Akash. We'll go to Patrik and then potentially Lucas to talk about both pricing long term and margins.

    謝謝,阿卡什。我們將與帕特里克以及可能的盧卡斯討論長期定價和利潤率。

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • WelI, I would say, when we look at the overall portfolio, I think we have stated from the beginning that we will continue to take a very disciplined approach here but also what Dave shared, we probably see an evolution here where you see a delta in between this price and net price of patients. And I think that's pretty much what's guiding us from a portfolio perspective moving forward.

    好吧,我想說,當我們審視整體投資組合時,我認為我們從一開始就聲明,我們將繼續採取非常嚴謹的方法,但正如戴夫所分享的,我們可能會看到一種演變,你會看到這個價格和患者淨價之間存在差異。我認為這基本上就是從投資組合的角度來引導我們前進的方向。

  • Lucas Montarce - Executive Vice President and Chief Financial Officer

    Lucas Montarce - Executive Vice President and Chief Financial Officer

  • Yeah, and I already commented from the pricing perspective, I think the price impressions are consistent with the trends that we have seen in the last 12 months, and that's what we are forecasting moving forward. This is a very dynamic situation as well, but we remain disciplined on our approach to provide optionality and have an open access for patients.

    是的,我已經從定價角度發表了評論,我認為價格印象與我們在過去 12 個月看到的趨勢一致,這也是我們對未來的預測。這也是一個非常動態的情況,但我們仍然堅持我們的方法,為患者提供可選性並開放取用。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Okay. Thank you, Lucas. Thank you, Patrick. Next question.

    好的。謝謝你,盧卡斯。謝謝你,派崔克。下一個問題。

  • Operator

    Operator

  • Trung Huynh, UBS.

    Trung Huynh,瑞銀。

  • Trung Huynh - Analyst

    Trung Huynh - Analyst

  • Hi guys, thanks for the question. Just on orfor obesity expectations. So in a similar way to outlining your thoughts on the orfor diabetes achieve data, how you thinking about the weight loss for orfor in the attain obesity studies? And on the tolerability side of things, can you just give us any color on when you had those GI side effects and discontinuations in ACHIEVE, was it early or later, just thinking about how tolerability could be from the attain versus ACHIEVE studies? Thanks.

    大家好,感謝您的提問。只是對肥胖的預期。因此,以類似的方式概述您對 orfor 糖尿病實現數據的想法,您如何看待 orfor 在實現肥胖研究中的減肥效果?在耐受性方面,您能否告訴我們,您在 ACHIEVE 中出現胃腸道副作用和停藥的時間是早期還是晚期,只是想從 Attain 與 ACHIEVE 研究中比較耐受性如何?謝謝。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Trung. We'll go to Dan for the orfor questions.

    謝謝,Trung。我們將向丹提問。

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Thanks. These are important questions, particularly the expectations for the PCD study and probably take some pain again to remind people that this is a monotherapy GLP-1 agonists, not a dual agonist like tirzepatide.

    謝謝。這些都是重要的問題,特別是對 PCD 研究的期望,可能需要再次費力地提醒人們,這是單一療法 GLP-1 激動劑,而不是像 tirzepatide 這樣的雙重激動劑。

  • So we need to expect a weight loss that could be seen with GLP-1 monotherapy, which as we showed in SURMOUNT-5, is quite different than what you get with 2 actions that tirzepatide has. So SURMOUNT-5 was a 72-week trial in obesity patients that Lilly ran that included monotherapy GLP-1 injectable in the form of semaglutide up to 2.4 milligrams. And I think in that study, we achieved about 13.7% weight loss with the GLP-1 monotherapy.

    因此,我們需要預期 GLP-1 單一療法能夠實現減肥效果,正如我們在 SURMOUNT-5 中所展示的那樣,這與 tirzepatide 的兩種作用所獲得的效果截然不同。因此,SURMOUNT-5 是禮來公司針對肥胖症患者進行的一項為期 72 週的試驗,其中包括以高達 2.4 毫克的司美格魯肽形式註射的單一療法 GLP-1。我認為在那項研究中,我們透過 GLP-1 單一療法實現了約 13.7% 的減肥效果。

  • This is a similar trial. It's not exactly the same for orforglipron but probably, we should expect to be somewhere near that. I think on tolerability, that study also had about a 20%-some of the patients, maybe 21% of the patients with vomiting, which is probably the most reliable indicator of GI tolerability in the most consistent across trials. So that's our expectations. Again, it's still to match the best available data from an injectable. And in this case, I focused on the trial that we conducted since we're conducting this trial with orforglipron.

    這是一次類似的試驗。對於 orforglipron 來說,情況並不完全相同,但可能我們應該期望它接近這個水平。我認為就耐受性而言,該研究也發現大約有 20% 的患者,也許是 21% 的患者出現嘔吐,這可能是在最一致的試驗中胃腸道耐受性的最可靠指標。這就是我們的期望。再次強調,它仍然是為了匹配注射劑的最佳可用數據。在這種情況下,我專注於我們進行的試驗,因為我們正在使用 orforglipron 進行這項試驗。

  • With respect to when did the discontinuations and tolerability events occur in the previous study, I think it was pretty similar to what we've seen in the past with injectables that usually these things happen early in the study and when people increase their dose, actually, some of the difference between the top two doses was probably just a chance because it happened pretty early in the study when actually patients would have been on the same dose level during the escalation scheme. So nothing of concern there. I think if we'd seen a different pattern with the events happening late in the study, I think that would be a more concerning, but that is not what we saw.

    關於先前的研究中停藥和耐受性事件何時發生,我認為這與我們過去在註射劑中看到的情況非常相似,通常這些事情發生在研究早期,當人們增加劑量時,實際上,最高兩個劑量之間的一些差異可能只是一個偶然,因為它發生在研究的早期,而實際上患者在升級方案期間的劑量水平是相同的。因此沒有什麼好擔心的。我認為,如果我們在研究後期發生的事件中看到不同的模式,那將更加令人擔憂,但這不是我們所看到的。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Dan. We're going to try to do a couple of more quick ones. So next question, please.

    偉大的。謝謝,丹。我們將嘗試做更多快速的事情。請問下一個問題。

  • Operator

    Operator

  • Carter Gould, Cantor.

    卡特·古爾德,領唱者。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • Good morning. Thanks for taking the question. I appreciate all the upfront commentary on tariffs. I guess, Dave, given sort of your unique perspective in Lilly's active role in shaping policy. It's somewhat surprising, we didn't hear you talk about some of the drug pricing risk. I guess anything you can share there around if you think potential MFN legislation is a priority or possibility in the coming balance of the year? Thank you.

    早安.感謝您回答這個問題。我感謝所有關於關稅的坦率評論。我想,戴夫,鑑於你對禮來在製定政策方面所發揮的積極作用的獨特看法。有點令人驚訝的是,我們沒有聽到您談論一些藥品定價風險。如果您認為潛在的最惠國立法是今年下半年的優先事項或可能性,您能分享一些什麼嗎?謝謝。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Yeah, well, I think it's always a risk for the industry. I think we point out that it's not coherent to have a discussion about that without talking about real net pricing versus real pricing in Europe, and that pulls you into a PBM reform discussion and a 340B discussion. So it's a complicated manner, I think you have to ask what would be the vehicle for such a thing? And there's certainly appetite in both parties to pursue this.

    是的,我認為這對行業來說始終是一個風險。我認為我們指出,如果不討論實際淨定價與歐洲的實際定價,那麼討論這個問題是不連貫的,這會把你拉進 PBM 改革討論和 340B 討論中。所以這是一種複雜的方式,我想你必須問,實現這種事情的載體是什麼?雙方確實都有意願實現這一目標。

  • Our goal, by the way, long term is to make sure that we can have a discussion, as I mentioned earlier, a trade with Europe that would really change how drugs are priced in that continent and developed economies pay more for the R&D cost. That's the real answer here.

    順便說一下,我們的長期目標是確保我們能夠進行討論,正如我之前提到的,與歐洲進行貿易,這將真正改變歐洲大陸的藥品定價方式,並使發達經濟體支付更多的研發成本。這才是真正的答案。

  • But I think right now, we're hyper focused as an industry on fixing the IRA problem that was created as to small molecules. I think our enthusiasm for that policy change is high, and that will be the focus on the build that's being contemplated now in May to get out of the house.

    但我認為現在,我們整個產業都高度專注於解決因小分子而產生的 IRA 問題。我認為我們對這項政策變化的熱情很高,這將成為目前正在考慮的 5 月建設的重點。

  • So that's the focus today, and we'll try to manage the risk you're talking about in the background all the while pointing out that it can't be independently looked at a list price in the US versus Europe, it's a nonsensical idea.

    這就是今天的重點,我們將嘗試管理您在幕後談論的風險,同時指出不能獨立地看待美國和歐洲的標價,這是一個荒謬的想法。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Dave. We'll try to squeeze in one or two more.

    謝謝,戴夫。我們會盡力再擠進一兩個。

  • Operator

    Operator

  • Rajesh Kumar, HSBC.

    拉傑什·庫馬爾,匯豐銀行。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • Hi there. Thanks for taking my question. Just on access and coverage of Zepbound, could you update us on how that looks now compared to, say, a year back same time how many more patients have coverage in the US? And what are the next steps, especially in light of compounders being blocked from filling campaign products, which are no longer allowed for Lilly product at the moment?

    你好呀。感謝您回答我的問題。關於 Zepbound 的訪問和覆蓋範圍,您能否向我們介紹現在的情況,與一年前同期相比,美國有多少患者獲得了覆蓋?那麼下一步該怎麼做呢,特別是考慮到複合劑製造商被禁止填充活動產品(目前不再允許用於禮來產品)?

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • So go to Patrik for an update on Zepbound access progress.

    因此,請向 Patrik 詢問有關 Zepbound 訪問進度的最新情況。

  • Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

    Patrik Jonsson - Executive Vice President; President, Lilly Cardiometabolic Health; President, Lilly USA

  • Thank you very much. You know what I think we shared earlier about the formulary access is probably the easiest step, and the more challenging step is going to get employees to opt in. And we've made some significant progress there in 2024. We started the year with approximately 50% of the employers opting in. And by the end of 2024, we were at mid to the high 50s.

    非常感謝。您知道我認為我們之前分享的有關處方集訪問可能是最簡單的一步,而更具挑戰性的一步是讓員工選擇加入。2024 年我們在這方面取得了一些重大進展。今年年初,大約有 50% 的雇主選擇加入。到 2024 年底,這一數字將達到 50 多歲。

  • So progress on employer opt in. But also in other segments, in Medicaid, we have actually moved from 11 states being covered by the end 2024 to 14 states covering now an incremental state Medicaid that have opted in April, specifically for OSA.

    因此雇主選擇加入的進展。但在其他領域,在醫療補助方面,我們實際上已經從 2024 年底覆蓋的 11 個州增加到現在覆蓋的 14 個州,這些州已於 4 月選擇增加州醫療補助,特別是針對 OSA。

  • And on OSA, we know that the CMS has issued guidance that plans can reimburse for OSA, but they have 180 days since the approval, which took place late December last year. We expect some progress in Medicare as well during the second half of this year. In terms of compounding, I think it's really hard to assess the magnitude of that market. But I think a couple of important cuts here, not all of those patients are necessarily on label.

    關於 OSA,我們知道 CMS 已經發布了指導意見,計劃可以報銷 OSA,但自去年 12 月下旬批准以來,他們有 180 天的時間。我們預計今年下半年醫療保險也會取得一些進展。從複合角度來看,我認為很難評估該市場的規模。但我認為這裡有幾個重要的削減,並不是所有的病人都一定符合標籤要求。

  • And b, that is also a matter of pricing, then we believe that our price point of 349 is actually quite competitive. And thirdly, in terms of the overall presence in the marketplace, where we currently have a strong momentum with more than 75% of patients starting anti-obesity treatment starting on Zepbound. So I think we'll continue to execute along those lines across all segments and we see progress being made every week.

    b,這也是一個定價問題,那麼我們相信我們的 349 價格點實際上是相當有競爭力的。第三,就整體市場佔有率而言,我們目前發展勢頭強勁,超過 75% 的患者透過 Zepbound 開始接受減重治療。因此我認為我們將繼續在所有領域執行這些方針,並且我們每週都會看到取得進展。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Great. Thanks, Patrick, and then last question please.

    偉大的。謝謝,派崔克,請問最後一個問題。

  • Operator

    Operator

  • Kripa Devarakonda, Truist Securities.

    Kripa Devarakonda,Truist 證券公司。

  • Kripa Devarakonda - Analyst

    Kripa Devarakonda - Analyst

  • Hey guys, thank you so much for taking my question. I have a question about the [Mounjaro] phase trial which is expected to be completed by June. Any update on when we might see data? We've heard the potential to see data in June at a conference. Also, can you help set expectations for the data? Thank you so much.

    嘿夥計們,非常感謝你們回答我的問題。我有一個關於[Mounjaro]階段試驗的問題,預計將於 6 月完成。關於我們何時可以看到數據,有任何更新嗎?我們聽說有可能在六月的一次會議上看到數據。另外,您能幫忙設定數據預期嗎?太感謝了。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Kripa. We'll go to Dan to talk about the Mounjaro.

    謝謝,克里帕。我們將去找丹談論蒙札羅 (Mounjaro)。

  • Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

    Daniel Skovronsky - Executive Vice President; Chief Scientific Officer and President, Lilly Research Laboratories; President, Immunology

  • Yeah, thank you for the question on Mounjaro. There are actually two Phase II trials. The first one that was conducted actually before we acquired the asset was in combination with semaglutide. That will be the data that will be disclosed first. the ongoing trial is in combination with tirzepatide. And of course, that's the trial of greater interest to us and I don't think we've commented on when we might disclose that data. Remember that this is an agent that was designed to see if we could have an effect on -- a positive effect on lean mass as well as a decrease in fat mass. And so that's what we're trying to see how that works in combination with these drugs.

    是的,感謝您提出有關 Mounjaro 的問題。實際上有兩項 II 期試驗。在我們收購該資產之前實際進行的第一次試驗是與司美格魯肽共同進行的。這將是首先披露的數據。正在進行的試驗是與 tirzepatide 聯合進行的。當然,這是我們最感興趣的試驗,我認為我們還沒有評論何時會披露這些數據。請記住,我們設計這種藥劑的目的是觀察它是否能夠對瘦體重產生正面影響,並減少脂肪量。因此,我們正在嘗試了解它與這些藥物結合後如何發揮作用。

  • Mike Czapar - Senior Vice President Investor Relations

    Mike Czapar - Senior Vice President Investor Relations

  • Thanks, Dave, for closing comments.

    謝謝 Dave 的最後評論。

  • David Ricks - Chairman of the Board, President, Chief Executive Officer

    David Ricks - Chairman of the Board, President, Chief Executive Officer

  • Okay. Great. Thank you all for participating today on our earnings call and your interest in the company. Please follow up with the IR team as you have questions, which I'm sure you will after today. Everyone have a great day, take care, thank you.

    好的。偉大的。感謝大家今天參加我們的收益電話會議並感謝你們對公司的關注。如果您有任何問題,請與 IR 團隊聯繫,我相信您今天之後會這樣做。祝大家有個愉快的一天,保重,謝謝。

  • Operator

    Operator

  • Thank you. And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00 PM today running through June 5 at midnight. You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 538637. International callers can call (973) 528-0005.

    謝謝。女士們、先生們,今天的會議到此結束。本次會議的重播將於今天下午 1:00 開始,一直持續到 6 月 5 日午夜。您可以隨時撥打 (800) 332-6854 並輸入存取代碼 538637 來存取重播系統。國際電話可撥打 (973) 528-0005。

  • Again, those numbers are (800) 332-6854 and (973) 528-0005 with the access code 538637. Thank you for your participation. You may now disconnect your lines.

    再次重申,這些號碼是 (800) 332-6854 和 (973) 528-0005,接入碼為 538637。感謝您的參與。現在您可以斷開線路了。