禮來公司 (LLY) 2024 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q2 2024 Earnings Call. (Operator Instructions) I would now like to turn the conference over to your host, Joe Fletcher, 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 2024 年第二季財報電話會議。 （操作員指示）我現在想將會議轉交給東道主投資者關係高級副總裁喬·弗萊徹 (Joe Fletcher)。請繼續。

Thanks, Paul. Good morning, everyone. Thanks for joining us for Eli Lilly and Company's Q2 2024 Earnings Call. I'm Joe Fletcher, Senior Vice President of Investor Relations. And joining me on today's call are Dave Ricks, Lilly's Chairman and CEO; and Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology; Gordon Brooks, Interim Chief Financial Officer; Anne White, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly International; Jake Van Naarden, President of Lilly Oncology; and Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA. And we're also joined by [Makela Irons, Mike Springate, Lauren Zurke] of the IR team.

謝謝，保羅。大家早安。感謝您參加禮來公司 2024 年第二季財報電話會議。我是喬‧弗萊徹，投資人關係資深副總裁。與我一起參加今天電話會議的還有禮來公司董事長兼執行長 Dave Ricks；禮來免疫學公司首席科學官兼總裁 Dan Skovronsky 博士；戈登‧布魯克斯，臨時財務長； Anne White，禮來神經科學公司總裁；伊利亞‧尤法 (Ilya Yuffa)，禮來國際公司總裁； Jake Van Naarden，禮來腫瘤學總裁；以及禮來心臟代謝健康公司和禮來美國公司總裁 Patrik Jonsson。 IR 團隊的 [Makela Irons、Mike Springate、Lauren Zurke] 也加入了我們。

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.

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。由於多種因素，包括幻燈片4 中列出的因素，我們的實際結果可能會存在重大差異。向SEC 提交的文件中。

The information we provide about our products and pipeline is for the benefit of the investment community. It's 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 non-GAAP financial measures.

我們提供有關我們的產品和管道的資訊是為了投資界的利益。它的目的不是為了促銷，也不足以做出決策。當我們轉向準備好的評論時，請注意，我們的評論將重點放在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。

Thanks, Joe. It's an exciting time here at Lilly as our growth trajectory accelerated in the second quarter. Our investments in advancing innovative medicine are focused on manufacturing expansion are bringing Lilly medicines to more people around the world.

謝謝，喬。在禮來公司，這是一個令人興奮的時刻，我們的成長軌跡在第二季度加速。我們在推動創新藥物方面的投資重點是擴大生產規模，將禮來藥品帶給世界各地更多的人。

On slide 5, you can see details of the financial performance in the second quarter and progress related to our strategic deliverables. Revenue grew 36% in Q2 with our new products growing nearly $3.5 billion compared to the same period last year. US demand for Mounjaro and Zepbound is strong and growing as access and supply continue to expand. While weekly prescription volume was volatile in the first half of the year due to challenges fulfilling high demand, our progress on supply gives us confidence in our outlook.

在投影片 5 上，您可以看到第二季財務表現的詳細資訊以及與我們的策略交付成果相關的進展。第二季營收成長 36%，新產品與去年同期相比成長近 35 億美元。美國對 Mounjaro 和 Zepbound 的需求強勁，並且隨著准入和供應的不斷擴大而不斷增長。儘管由於滿足高需求方面的挑戰，上半年每週處方量波動較大，但我們在供應方面的進展讓我們對前景充滿信心。

Q2 saw impressive performance across other areas of the business as well. Excluding the sale of the rights to Baqsimi last year, non-incretin growth was 17% worldwide with growth spread across geographies, including 25% growth in the United States. And our $3 billion increase in revenue guidance reflects our expectation that momentum will accelerate through the balance of the year.

第二季其他業務領域的表現也令人印象深刻。不包括去年出售 Baqsimi 的權利，全球非腸促胰島素增長了 17%，增長分佈在各個地區，其中美國增長了 25%。我們的收入指引增加了 30 億美元，反映出我們預計這一勢頭將在今年剩餘時間內加速。

We achieved several key pipeline milestones, including the approval of Kisunla, the brand name for donanemab in the US. for the treatment of Alzheimer's disease, the approval of Jaypirca in Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other BTK inhibitors, the submission of tirzepatide in the US. and the EU for the treatment of moderate to severe obstructive sleep apnea in adults with obesity and the positive top line results from the SUMMIT Phase III trial evaluating tirzepatide in adults with heart failure with preserved injection fraction and obesity.

我們實現了多個關鍵的管道里程碑，包括多南單抗 (donanemab) 在美國的品牌名稱 Kisunla 獲得批准。用於治療阿茲海默症、日本核准 Jaypirca 用於治療對其他 BTK 抑制劑抗藥性或不耐受的復發或難治性套細胞淋巴瘤患者、美國提交替澤帕肽。歐盟和歐盟用於治療肥胖成人中度至重度阻塞性睡眠呼吸中止症，並且 SUMMIT III 期試驗評估了替澤帕肽治療保留注射分數和肥胖的成人心臟衰竭的積極頂線結果。

Lilly now has a significant opportunity to create new medicines through a broad internal portfolio and active business development to support our long-term growth. In obesity, our strategy is to comprehensively address this global public health crisis, pursuing opportunities against every rational mechanism, indication and dosage form. We are investing broadly in this disease and now have 11 new molecules currently in the clinic across multiple indications.

禮來公司現在擁有一個重大機會，可以透過廣泛的內部產品組合和積極的業務發展來創造新藥，以支持我們的長期成長。在肥胖方面，我們的策略是全面應對這場全球公共衛生危機，針對每一種合理的機制、適應症和劑型尋求機會。我們正在對這種疾病進行廣泛投資，目前臨床上已有 11 種新分子，涵蓋多種適應症。

We're also investing in a wide range of late-stage Phase III programs. We recently shared the positive data of tirzepatide in OSA and -- Orforglipron, our oral GLP-1 small molecule, has a comprehensive Phase III program underway in diabetes and obesity with nine trials currently running and readout starting next year. With tirzepatide, our GIP, GLP-1 glucan try agonist. We have initiated a broad Phase III development program studying the molecule in obesity, OSA, osteoarthritis, cardiovascular and renal outcomes as well as type 2 diabetes. These readouts start in 2026.

我們也投資於一系列後期第三階段專案。我們最近分享了替澤帕肽治療OSA 的積極數據，並且Orforglipron（我們的口服GLP-1 小分子）正在針對糖尿病和肥胖症開展一項全面的III 期項目，目前正在運行9 項試驗，並從明年開始讀數。與替澤帕肽（我們的 GIP、GLP-1 葡聚醣嘗試激動劑）一起使用。我們已經啟動了一項廣泛的 III 期開發計劃，研究該分子在肥胖、OSA、骨關節炎、心血管和腎臟結局以及 2 型糖尿病方面的作用。這些讀數從 2026 年開始。

Our top priority remains executing on our ambitious manufacturing expansion agenda. In May, we announced plans to invest an additional $5.3 billion in our Lebanon, Indiana manufacturing sites, bringing our total investment there to $9 billion. We believe this is the largest single investment in synthetic medicine active pharmaceutical ingredient manufacturing in the history of the United States. Importantly, this expansion will enhance -- to manufacture active pharmaceutical ingredients for Zepbound and Mounjaro. Since 2020, we have committed more than $18 billion to build, upgrade or acquire facilities in the US. and Europe, and we began to see the benefit of these investments.

我們的首要任務仍然是執行雄心勃勃的製造業擴張議程。 5 月份，我們宣布計劃在黎巴嫩和印第安納州的製造基地追加投資 53 億美元，使我們在那裡的總投資達到 90 億美元。我們相信這是美國史上合成藥物活性藥物成分製造領域最大的單筆投資。重要的是，這項擴張將增強 Zepbound 和 Mounjaro 的活性藥物成分的生產。自 2020 年以來，我們已承諾投入超過 180 億美元在美國建造、升級或收購設施。和歐洲，我們開始看到這些投資的好處。

We are making near-term progress to ramp production, including at new sites like Research Trial Park, existing Lilly sites and contract manufacturing organizations. Our Concur North Carolina site is progressing well. We're in the process of running validation and expect this facility will initiate production by the end of 2024 with product available to ship in 2025.

我們近期正在擴大生產方面取得進展，包括研究試驗園等新工廠、禮來公司現有工廠和合約製造組織。我們的 Concur 北卡羅來納州網站進展順利。我們正在運行驗證，預計該工廠將於 2024 年底開始生產，產品將於 2025 年發貨。

We also continue to make progress on different presentations for tirzepatide. We have now launched our multidose quick pen in multiple markets outside the US. with positive early indicators of patient adoption. And in Gordon's remarks, he will preview our plans to launch vials here in the US

我們也繼續在替西帕肽的不同演示方面取得進展。我們現已在美國以外的多個市場推出了多劑量快速筆。具有患者採用的正面早期指標。在戈登的演講中，他將預覽我們在美國推出小瓶的計劃

Lastly, in terms of external innovation. In July, we announced a definitive agreement to acquire Morphic, a biopharma company developing oral -- therapies for treatment of serious chronic diseases, including a Phase II asset being evaluated in inflammatory bowel disease.

最後，在外部創新方面。 7 月，我們宣布達成收購 Morphic 的最終協議，Morphic 是一家開發治療嚴重慢性疾病的口服療法的生物製藥公司，其中包括正在評估發炎性腸道疾病的 II 期資產。

On slide 6, you'll see a list of key events since our Q1 call, including the milestones I mentioned earlier and several other important updates.

在幻燈片 6 上，您將看到自第一季電話會議以來的關鍵事件列表，包括我之前提到的里程碑和其他幾個重要更新。

As we announced in June, Anat Ashkenazi resigned as Lilly's Chief Financial Officer to become the CFO of Alphabet. We wish Anat well in her new role and thank her for your partnership and leadership of our financial organization in the last 3 years.

正如我們在 6 月宣布的那樣，阿納特·阿什肯納齊 (Anat Ashkenazi) 辭去禮來 (Lilly) 首席財務官職務，出任 Alphabet 首席財務官。我們祝福 Anat 在新職位上一切順利，並感謝她在過去 3 年裡對我們金融組織的合作和領導。

We have named Gordon Brooks Interim CFO as an internal and external search for Anat successor is currently underway. Gordon has been with the company for 29 years and also serves as our controller and the leader of the corporate strategy group for the company.

我們已任命 Gordon Brooks 為臨時財務官，目前正在內部和外部尋找 Anat 繼任者。 Gordon 在公司工作 29 年，也擔任我們的財務長和公司策略小組的領導者。

In other leadership news, [Alonzo Willms], our Executive Vice President of Enterprise Risk Management and our Chief Ethics and Compliance Officer, will retire at the end of the year after 27 years of service. And [Melissa Seymour] has joined the company as Executive Vice President of Global Quality and a member of the company's executive committee following [John Norton's] recent retirement. I want to thank Alonzo for his many years of service and welcome Melissa to the Lilly team.

在其他領導層新聞中，我們的企業風險管理執行副總裁兼首席道德與合規官 [Alonzo Willms] 將在服務 27 年後於今年年底退休。在[約翰·諾頓]最近退休後，[梅麗莎·西摩]加入公司擔任全球品質執行副總裁和公司執行委員會成員。我要感謝阿朗佐多年來的服務，並歡迎梅莉莎加入禮來團隊。

Now let me turn the call over to Gordon to review our Q2 financial results.

現在讓我把電話轉給戈登，回顧我們第二季的財務表現。

Thanks, Dave. So I'm on slide 7, which summarizes the financial performance in the second quarter of 2024. Second quarter revenue growth of 36% was primarily driven by Mounjaro and Zepbound as well as Verzenio. When excluding revenue from the sale of rights to Baqsimi in Q2 of last year, revenue grew 46%. Gross margin as a percent of revenue increased from 79.8% in Q2 of '23 to 82% in Q2 of '24. Gross margin in the quarter benefited from favorable product -- and higher realized prices, partially offset by higher production costs.

謝謝，戴夫。我在投影片 7 上總結了 2024 年第二季的財務表現。如果排除去年第二季出售 Baqsimi 版權的收入，則收入成長了 46%。毛利率佔營收的百分比從 23 年第二季的 79.8% 上升到 24 年第二季的 82%。本季的毛利率得益於有利的產品和更高的實現價格，但部分被更高的生產成本所抵消。

R&D expenses increased 15% driven by continued investment in our portfolio and in our people. Marketing, selling and administrative expenses increased 10%, primarily driven by promotional efforts associated ongoing and future launches as well as investments in our people.

由於對我們的產品組合和員工的持續投資，研發費用增加了 15%。行銷、銷售和管理費用增加了 10%，主要是由於與正在進行和未來的產品發布相關的促銷活動以及對員工的投資。

Operating income increased 90% in Q2, driven by higher revenue from new products, partially offset by operating expense growth. The effective tax rate on a non-GAAP basis was 16.5% in Q2 of '24 compared with 16.1% in Q2 of '23. The Q2 '24 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 '23 rate reflected the impact of earnings from the sale of rights for Baqsimi.

在新產品收入增加的推動下，第二季營業收入成長了 90%，但部分被營業費用成長所抵銷。 24 年第二季以非公認會計原則計算的有效稅率為 16.5%，而 23 年第二季為 16.1%。 24 年第二季的稅率反映了高稅收管轄區的收入組合，而 23 年第二季的稅率則反映了 Baqsimi 權利出售收入的影響。

At the bottom line, we delivered earnings per share of $3.92 in Q2, an 86% increase compared to the prior year. Q2 '24 results include a negative impact of $0.14 from acquired IPR&D charges compared to $0.09 in the prior quarter, Q2 of '23.

從底線來看，我們第二季的每股收益為 3.92 美元，比去年同期成長 86%。 2024 年第二季的業績包括因收購的 IPR&D 費用而產生的 0.14 美元的負面影響，而上一季（23 年第二季）的負面影響為 0.09 美元。

On slide 9, we quantify the effect of price, rate and volume on revenue growth. US revenue increased 42% in Q2. Volume growth of 27% was driven by Zepbound, Mounjaro and Verzenio, partially offset by sale of rights for Baqsimi in Q2 of '23 and declines in Trulicity. Realized prices increased 15%, largely driven by Mounjaro access and savings card dynamics.

在投影片 9 中，我們量化了價格、費率和數量對收入成長的影響。第二季美國營收成長 42%。 27% 的銷售成長是由 Zepbound、Mounjaro 和 Verzenio 推動的，但部分被 23 年第二季 Baqsimi 的權利出售和 Trulicity 的下降所抵消。實際價格上漲了 15%，這主要是受到 Mounjaro 准入和儲蓄卡動態的推動。

As noted in our Q4 -- Q1 2024 earnings call, unprecedented demand for our incretin medicines led to wholesaler back orders at the end of Q1. In Q2, we fulfilled the majority of these back orders, improving wholesaler stocking levels. We estimate that US Mounjaro and Zepbound aggregate sales in the second quarter were positively impacted by channel stocking that we estimate totaled high teens to mid-20s as a percent of US sales as we rebuilt inventory from extremely low levels in the spring and to account for the growth of these brands.

正如我們在 2024 年第四季至第一季財報電話會議中指出的那樣，對我們的腸促胰島素藥物的前所未有的需求導致批發商在第一季末缺貨。第二季度，我們履行了大部分延期交貨訂單，並提高了批發商的庫存水準。我們估計第二季美國Mounjaro 和Zepbound 的總銷售額受到了通路庫存的正面影響，我們估計通路庫存占美國銷售額的百分比高達10 到20 多歲，因為我們在春季從極低的水平重建了庫存，並考慮到這一點。

We are pleased that the group's supply situation is reflected on the FDA shortage website, which currently shows all doses of Mounjaro and Zepbound, listed as available and the two lower doses of Trulicity as available.

我們很高興該集團的供應情況反映在 FDA 短缺網站上，該網站目前顯示所有劑量的 Mounjaro 和 Zepbound 均已上市，以及兩種較低劑量的 Trulicity 都已上市。

While wholesaler back orders in the US have been reduced substantially, it's important to note that the pharmaceutical supply chain is complex, more so for medicines that require refrigeration and offer at several different doses. These factors may continue to result in variability in the patient experience at the pharmacy counter.

儘管美國批發商的延期交貨訂單已大幅減少，但值得注意的是，藥品供應鏈非常複雜，對於需要冷藏並提供多種不同劑量的藥品來說更是如此。這些因素可能會持續導致患者在藥局櫃檯的體驗發生變化。

While supply and demand has come into better balance, we expect increase in demand may result in periodic supply tightness for certain presentations and dose levels. We have a continued broad agenda to further increase supply, and we'll continue to look at all options.

雖然供需已達到更好的平衡，但我們預計需求的增加可能會導致某些演示和劑量水平的周期性供應緊張。我們有一個持續廣泛的議程來進一步增加供應，我們將繼續考慮所有選擇。

Today, we are excited to announce plans to further expand access to Zepbound with the launch of the 2.5-milligram and 5-milligram single-dose files in the coming weeks with more details to come at that time.

今天，我們很高興地宣布計劃進一步擴大 Zepbound 的使用範圍，在未來幾週內推出 2.5 毫克和 5 毫克單劑量文件，屆時將提供更多細節。

In Europe, revenue grew 20% in constant currency, primarily driven by Mounjaro launch uptake in the UK and Germany. We also had strong volume growth from Verzenio, Jardiance, which was partially offset by decreased volume from Trulicity.

在歐洲，以固定匯率計算，營收成長了 20%，這主要得益於 Mounjaro 在英國和德國的推出。 Verzenio、Jardiance 的銷量也出現強勁增長，但 Trulicity 的銷量下降部分抵消了這一增長。

Japan performance was strong in the second quarter with 15% revenue growth in constant currency. Volume growth of 21% was driven by uptake of Mounjaro and Verzenio.

日本第二季表現強勁，以固定匯率計算營收成長 15%。 Mounjaro 和 Verzenio 的採用推動了銷量成長 21%。

Moving to China. Q2 revenue increased 1% in constant currency. Growth was driven by -- Olumiant and Taltz, partially offset by Trulicity and Cialis. Mounjaro was recently approved in China for type 2 diabetes and chronic weight management. We have not yet announced expected launch timing in this market.

搬到中國。以固定匯率計算，第二季營收成長 1%。成長由 Olumiant 和 Taltz 推動，但被 Trulicity 和 Cialis 部分抵消。 Mounjaro 最近在中國已被批准用於第 2 型糖尿病和慢性體重管理。我們尚未宣佈在該市場的預計推出時間。

Revenue in Rest of World increased 61% in constant currency, primarily driven by Mounjaro volume growth from demand and channel dynamics.

以固定匯率計算，世界其他地區的收入成長了 61%，這主要是受到需求和通路動態帶來的 Mounjaro 銷售成長的推動。

slide 10 provides additional perspective on performance across our product categories. Verzenio solid growth in the second quarter across major geographies with worldwide sales increasing 44%, driven by the early breast cancer indication. Jaypirca revenue increased to $92 million worldwide, which included a $19 million partner milestone payment related to Japan. Jaypirca continued impressive quarter-over-quarter growth, building on the brand's uptake from both the MCL and CLL patient populations.

投影片 10 提供了更多有關我們產品類別績效的觀點。在早期乳癌適應症的推動下，Verzenio 第二季度在主要地區實現穩健成長，全球銷售額成長 44%。 Jaypirca 全球營收增至 9,200 萬美元，其中包括與日本相關的 1,900 萬美元合作夥伴里程碑付款。 Jaypirca 繼續保持令人印象深刻的季度環比增長，該品牌在 MCL 和 CLL 患者人群中得到廣泛應用。

(inaudible) is launched in the US and 14 international markets with sales of $26 million in Q2. These launches continue to progress well with increasing patient starts. And in the US, we expect sales to accelerate as the product-specific code went live on July 1.

（聽不清楚）在美國和 14 個國際市場推出，第二季銷售額達 2,600 萬美元。隨著患者開始增加，這些產品的推出持續進展順利。在美國，隨著產品特定代碼於 7 月 1 日上線，我們預期銷售將會加速。

Mounjaro sales in Q2 were $3.1 billion globally with $2.4 billion in the US Revenue growth in the US reflected continued strong demand as well as the improved channel dynamics discussed earlier. We're seeing solid uptake in Mounjaro outside the US, with sales in Q2 totaling $677 million.

Mounjaro 第二季度的全球銷售額為 31 億美元，其中美國銷售額為 24 億美元。我們看到 Mounjaro 在美國以外的銷售量強勁，第二季銷售額總計 6.77 億美元。

In the first half of the year, we launched the quick pen presentation in the UK, Germany and the UAE. So far in Q3, we've also launched Mounjaro Quick Pen in Spain and plan to launch an additional markets throughout 2024.

上半年，我們在英國、德國和阿聯酋推出了快筆示範。到目前為止，第三季度，我們還在西班牙推出了 Mounjaro Quick Pen，並計劃在 2024 年推出更多市場。

In Q2, worldwide Trulicity revenue declined 31%. US Trulicity revenue decreased 36% driven by lower volume, primarily due to competitive dynamics and supply constraints, partially offset by improved wholesaler stocking levels on services.

第二季度，Trulicity 全球營收下降了 31%。由於競爭動態和供應限制，銷售下降導緻美國 Trulicity 收入下降 36%，但批發商服務庫存水準的提高部分抵消了這一影響。

Turning to slide 11. We have an update on the US launch of Zepbound. We've seen exceptional growth trends for Zepbound that have accelerated as production has ramped leading to sales of over $1.2 billion in Q2. We are rapidly building our formulary coverage for Zepbound in the US and as of July 1 had approximately 86% access in the commercial segment. We estimate over 50% of employers have opted into anti-obesity medicine coverage and see that modestly growing as we work to expand coverage.

轉向幻燈片 11。我們看到 Zepbound 的非凡成長趨勢隨著產量的增加而加速，導致第二季銷售額超過 12 億美元。我們正在快速建立 Zepbound 在美國的處方覆蓋範圍，截至 7 月 1 日，商業領域的覆蓋率約為 86%。我們估計超過 50% 的雇主選擇了抗肥胖藥物承保範圍，並且隨著我們努力擴大承保範圍，這一比例將適度增長。

On slide 12, we provide an update on our capital allocation.

在投影片 12 上，我們提供了資本配置的最新資訊。

slide 13 shows our updated 2024 financial guidance. We are raising our full year revenue outlook by $3 billion to be between $45.4 million and $46.6 billion. This increase is due to strong performance across our non-incretin medicines as well as Mounjaro and Zepbound. Additionally, we have improved clarity into the timing and pace of our production expansion and Mounjaro launches outside the US

投影片 13 顯示了我們更新的 2024 年財務指引。我們將全年營收預期調高 30 億美元，達到 4,540 萬美元至 466 億美元之間。這一增長得益於我們的非腸促胰島素藥物以及 Mounjaro 和 Zepbound 的強勁表​​現。此外，我們也進一步明確了生產擴張和 Mounjaro 在美國以外地區推出的時間和節奏

We achieved a number of supply-related milestones in Q2 and have increased confidence regarding our expectation that production of salable doses of incretin medicines in the second half of 2024 will be at least 1.5 times the salable doses taken half of 2023.

我們在第二季度實現了許多與供應相關的里程碑，並對我們的預期更有信心，即2024 年下半年腸促胰島素藥物的可銷售劑量產量將至少是2023 年下半年可銷售劑量的1.5 倍。

Based on the midpoint of the range, our updated guidance implies revenue growth of 38% in the second half of the year, [below] 31% in the first half. In the second half of the year, we expect a more significant growth in Q4 compared to Q3.

根據該範圍的中點，我們更新後的指引意味著下半年收入成長 38%，[低於]上半年 31%。下半年，我們預計第四季相比第三季會有更顯著的成長。

Given the update to revenue guidance, we now expect the ratio of gross margin less OpEx divided by revenue to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis. For other income and expense, we now expect between $525 million and $425 million of expense on a reported basis, and between $400 million and $300 million of expense on a non-GAAP basis. Both ranges reflect lower expected net interest expense and the reported range reflects net losses on investments in equity securities through Q2 of '24.

鑑於收入指引的更新，我們現在預計毛利率減去營運支出除以收入的比率在報告基礎上將在 36% 至 38% 之間，在非 GAAP 基礎上將在 37% 至 39% 之間。對於其他收入和支出，我們現在預計報告費用在 5.25 億美元到 4.25 億美元之間，按照非公認會計準則計算費用在 4 億美元到 3 億美元之間。這兩個範圍都反映了較低的預期淨利息支出，報告的範圍反映了截至 24 年第二季的股本證券投資淨虧損。

We have increased our estimated effective tax rate to be approximately 15%, driven by changes in our forecasted mix of earnings in higher tax jurisdictions. Earnings per share is now expected to be in the range of $15.10 to $15.60 on a reported basis $16.10 to $16.60 on a non-GAAP basis. Both ranges -- the updates mentioned earlier as well as acquired IPR&D charges through Q2 of $0.24. The reported range includes a charge in Q2 of '24 associated with anticipated litigation payments.

由於高稅收司法管轄區的預測收益組合發生變化，我們將估計有效稅率提高至約 15%。目前預計每股收益在報告基礎上為 15.10 美元至 15.60 美元，按非公認會計準則計算為 16.10 美元至 16.60 美元。這兩個範圍——前面提到的更新以及截至第二季的 0.24 美元的智慧財產權和研發費用。報告的範圍包括 24 年第二季與預期訴訟付款相關的費用。

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

現在我將把電話轉給 Dan，強調我們在研發方面的進展。

Thanks, Gordon. It's been another busy quarter. I'll start with comments on the Kisunla FDA approval, then the tirzepatide heart failure Phase III readout. Then finally, I'll cover the rest of the updates for the quarter.

謝謝，戈登。這又是一個忙碌的季度。我將從 Kisunla FDA 批准的評論開始，然後是替西帕肽心臟衰竭 III 期讀數。最後，我將介紹本季的其餘更新。

We are, of course, very excited about the FDA approval of Kisunla for treatment of Alzheimer's disease. This followed the June Advisory Committee meeting where we had another chance to present and discuss the compelling data package characterizing the safety and efficacy of this medicine.

當然，我們對 FDA 批准 Kisunla 用於治療阿茲海默症感到非常興奮。在此之前，我們在六月的諮詢委員會會議上再次有機會展示和討論描述該藥物安全性和有效性的令人信服的數據包。

We were pleased by the discussion of the FDA advisers, particularly with regard to our data supporting stopping of Kisunla therapy when amyloid plaques are removed to minimal levels. In our trial, nearly half of study participants completed their course of treatment with Kisunla in 12 months. We believe limited duration therapy, along with a once monthly infusion schedule, could result in lower patient out-of-pocket treatment costs and fewer infusions required.

我們對 FDA 顧問的討論感到高興，特別是我們的數據支持當澱粉樣斑塊去除到最低水平時停止 Kisunla 治療。在我們的試驗中，近一半的研究參與者在 12 個月內完成了 Kisunla 的治療過程。我們相信，有限持續時間的治療以及每月一次的輸液計劃可能會降低患者的自付費用治療費用並減少所需的輸液量。

The vote was unanimously positive on all questions presented. Then a few weeks later, the FDA approved Kisunla, including labeling that physicians may consider stopping dosing of Kisunla based on reduction of amyloid plaques. Following the July approval, we launched Kisunla, and we're delighted to see that patients have already begun receiving this new Lilly medicine as part of clinical practice.

投票對提出的所有問題都一致贊成。幾週後，FDA 批准了 Kisunla，並註明醫生可以根據澱粉樣蛋白斑塊的減少情況考慮停止服用 Kisunla。繼 7 月獲得批准後，我們推出了 Kisunla，我們很高興看到患者已經開始接受這種新的禮來藥物作為臨床實踐的一部分。

We note that Kisunla is broadly covered for Medicare patients through approved CED registries. Regulatory reviews continue around the world with potential action yet this year in several countries.

我們注意到，Kisunla 透過經批准的 CED 登記處廣泛涵蓋 Medicare 患者。世界各地的監管審查仍在繼續，一些國家今年可能會採取行動。

We're pleased to have recently received a positive opinion for genenimab from the Pharmaceuticals and Medical Devices Agency in Japan. And finally, our Phase III prevention study, TRAILBLAZER ALS 3, continues to progress as planned.

我們很高興最近收到日本藥品和醫療器材管理局對 Genenimab 的正面評價。最後，我們的 III 期預防研究 TRAILBLAZER ALS 3 繼續按計劃取得進展。

Moving to tirzepatide. On slide 14, you'll see the recent positive results of our SUMMIT Phase III trial, which evaluated tirzepatide for the treatment of heart failure with preserved detection fraction and obesity. This study demonstrated statistically significant improvements in both primary endpoints for tirzepatide, maximum tolerated dose compared to placebo.

轉向替澤帕肽。在幻燈片 14 上，您將看到我們 SUMMIT III 期試驗的最新積極結果，該試驗評估了替西帕肽治療保留檢測分數和肥胖的心臟衰竭。這項研究表明，與安慰劑相比，替西帕肽的兩個主要終點（最大耐受劑量）都有統計學上的顯著改善。

In the first primary endpoint, tirzepatide reduced the risk of worsening heart failure by 38% compared to placebo as measured by a composite outcome of heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death. The median follow-up for this endpoint was 104 weeks.

在第一個主要終點中，與安慰劑相比，替澤帕肽將心臟衰竭惡化的風險降低了38%，這是透過心臟衰竭緊急就診或住院、口服利尿劑強化或心血管死亡的綜合結果來衡量的。此終點的中位追蹤時間為 104 週。

In the second primary endpoint, tirzepatide significantly improved heart failure symptoms and physical limitations compared to placebo as measured by the Kansas City Cardiomyopathy Questioner, KCCQ Clinical Summary score. Main changes from baseline in this measurement is 24.8 points for tirzepatide, while placebo was 15 points based on the efficacy as demand at 52 weeks. All key secondary endpoints were met in the study, including mean body weight reduction of 15.7% compared to 2.2% for placebo.

在第二個主要終點中，根據堪薩斯城心肌病變提問者 KCCQ 臨床總結評分，與安慰劑相比，替西帕肽顯著改善心臟衰竭症狀和身體限制。根據 52 週時的功效需求，替西帕肽相對於基線的主要變化為 24.8 分，而安慰劑為 15 分。研究中所有關鍵的次要終點均已滿足，包括平均體重減輕 15.7%，安慰劑組為 2.2%。

The overall safety profile of tirzepatide in the SUMMIT trial was consistent with previously reported tirzepatide studies, including SURMOUNT and SURPASS. We will present detailed results at an upcoming medical -- and submit to a peer review journal. We plan to submit results to the FDA and other regulatory agencies starting later this year.

SUMMIT 試驗中替澤帕肽的整體安全性與先前報告的替澤帕肽研究一致，包括 SURMOUNT 和 SURPASS。我們將在即將舉行的醫學會議上展示詳細的結果，並提交給同行評審期刊。我們計劃從今年稍後開始向 FDA 和其他監管機構提交結果。

In other updates across our portfolio, slide 15 shows select pipeline opportunities as of August 6. slide 16 shows potential key events for the year. I'll start with updates in cardiometabolic health, which is the new name of our internal business, formerly known as Lilly diabetes and obesity.

在我們投資組合的其他更新中，幻燈片 15 顯示了截至 8 月 6 日的精選管道機會。我將從心臟代謝健康的最新情況開始，這是我們內部業務的新名稱，以前稱為禮來糖尿病和肥胖症。

In June, we published detailed results for our Phase III trials of tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity in the New England Journal of Medicine, and we presented results at the American Diabetes Association Meeting. All primary and key secondary endpoints were achieved in these studies.

6 月，我們在《新英格蘭醫學雜誌》上發表了替西帕肽治療中度至重度阻塞性睡眠呼吸中止症和肥胖症的 III 期試驗的詳細結果，並在美國糖尿病協會會議上介紹了結果。這些研究中實現了所有主要和關鍵次要終點。

Notably, in one of our key secondary endpoints, as shown on slide 17, tirzepatide demonstrated that up to 51.5% of participants met the criteria for disease resolution of sleep apnea. We've now submitted tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity to the FDA as well as the EMA. We are pleased that the FDA has granted breakthrough therapy designation, and we expect US regulatory action as early as the end of 2024, which will be dependent on the FDA granting priority review.

值得注意的是，在我們的關鍵次要終點之一（如幻燈片 17 所示）中，替西帕肽證明高達 51.5% 的參與者符合睡眠呼吸中止症疾病緩解的標準。我們現已向 FDA 和 EMA 提交了用於治療中度至重度阻塞性睡眠呼吸中止症和肥胖的替澤帕肽。我們很高興 FDA 已授予突破性療法認定，我們預計美國最早將於 2024 年底採取監管行動，這將取決於 FDA 是否給予優先審查。

Also in June, we published results in the New England Journal from our Phase II trial of tirzepatide for metabolic dysfunction associated steatohepatitis, or MASH, with Stage II or III fibrosis and we presented these results at the European Association for the Study of (inaudible).

同樣在6 月，我們在《新英格蘭雜誌》上發表了替西帕肽治療伴有II 期或III 期纖維化的代謝功能障礙相關脂肪性肝炎(MASH) 的II 期試驗結果，並在歐洲研究協會(聽不清楚) 上發表了這些結果。

We are pleased to show that in a secondary endpoint, more than half of the patients taking tirzepatide achieved improvement in fibrosis at 52 weeks as shown on slide 18. We're engaged with regulatory authorities on a potential Phase III registration strategy, and we're also encouraged by the potential read-through of these results to retatrutide, which also showed significant improvements in liver fats in Phase II.

我們很高興地表明，在次要終點中，超過一半服用替澤帕肽的患者在52 週時實現了纖維化的改善，如幻燈片18 所示。策略進行合作，並且我們'我們也對這些結果可能被解讀為瑞他魯肽感到鼓舞，瑞他魯肽也顯示出 II 期肝脂肪的顯著改善。

This quarter, we also announced top line data from two Phase III trials for our once weekly insulin called efsitora alfa, the QWINT-2 and QWINT-4 trials for the treatment of type 2 diabetes each met their primary endpoints of non-inferior A1c reduction. QWINT-2 compared to efsitora once-daily insulin degludec for 52 weeks in insulin naive adults. QWINT-4 compared efsitora to insulin glargine for 26 weeks in adult previously treated with daily basal insulin and at least two injections per day of [meal time line] .

本季度，我們也公佈了每週一次的胰島素efsitora alfa 的兩項III 期試驗的主要數據，即用於治療2 型糖尿病的QWINT-2 和QWINT-4 試驗，均達到了非劣質A1c 降低的主要終點。 QWINT-2 與每日一次的 efsitora 德谷胰島素在未接受胰島素治療的成年人中進行比較，持續 52 週。 QWINT-4 在先前每天接受基礎胰島素治療且每天至少注射兩次[用餐時間線]的成年人中，對 efsitora 與甘精胰島素進行了 26 週的比較。

In both QWINT-2 and QWINT-4 efsitora, was safe and well tolerated. Detailed trial results will be presented in September at the European Association for the Study of Diabetes Annual Meeting. We look forward to sharing additional data from the QWINT program later this year.

在 QWINT-2 和 QWINT-4 efsitora 中，都是安全且耐受性良好的。詳細的試驗結果將於九月在歐洲糖尿病研究協會年會上發表。我們期待在今年稍後分享 QWINT 計劃的更多數據。

We are pleased with our progress to provide breakthrough innovation to patients who require insulin, progressing our glucose sensing insulin receptor agonist molecule in Phase I and investing in approaches aimed at disease modification for type 1 diabetes, such as -- cell therapy.

我們很高興能夠為需要胰島素的患者提供突破性創新，將我們的葡萄糖感應胰島素受體激動劑分子推進到 I 期，並投資於旨在改善 1 型糖尿病疾病的方法，例如細胞療法。

In other late-phase updates, we've initiated Triumph outcomes, a Phase III trial evaluating cardiovascular outcomes and renal function for patients taking retatrutide.. Earlier in our cardiometabolic pipeline, you'll see additional incretin molecules in Phase I. Incretins are an important part of our portfolio strategy and having multiple molecules in clinical development offers us potential optionality as we look at opportunities to help patients across mechanisms, indications, dosages, formulations and treatment schedules.

在其他後期更新中，我們啟動了Triumph 結果，這是一項評估服用瑞他魯肽的患者的心血管結果和腎功能的III 期試驗。看到其他腸促胰島素分子。適應症、劑量、配方和治療方案。

To highlight a few. GLP-1 NPA2 is a small molecule non-peptide agonist of the GLP-1 receptor designed for once daily oral administration. We expect this asset to move to Phase II later this year, so we now identify it on our pipeline slide whereas it had previously been listed as not disclosed.

強調幾個。 GLP-1 NPA2 是 GLP-1 受體的小分子非勝肽激動劑，每日口服一次。我們預計該資產將在今年稍後進入第二階段，因此我們現在在我們的管道幻燈片上識別它，而之前它被列為未披露。

Given the diversity of indications to potentially pursue with incretins, we are excited about the possibility of having another oral option to help more patients with different diseases.

鑑於腸促胰素潛在適應症的多樣性，我們很高興有可能有另一個口服選擇來幫助更多患有不同疾病的患者。

We also highlight today the GLP-1 coagonist 3, which is a next-generation dual agonist molecule and we are planning to explore weekly and monthly dosing given its longer halfway.

今天我們也重點介紹了 GLP-1 共激動劑 3，它是下一代雙激動劑分子，鑑於其中途較長，我們計劃探索每周和每月給藥方案。

Elsewhere in our cardiometabolic health portfolio, we have stopped development of our NRG4 agonist as the profile was insufficient for further clinical development.

在我們的心臟代謝健康產品組合中的其他地方，我們已經停止了 NRG4 激動劑的開發，因為其概況不足以進行進一步的臨床開發。

Turning to oncology. We are pleased that Jaypirca has now been approved in Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other BTK inhibitors.

轉向腫瘤學。我們很高興 Jaypirca 現已在日本獲準用於治療對其他 BTK 抑制劑抗藥性或不耐受的復發或難治性套細胞淋巴瘤患者。

In early phase oncology, we've initiated the Phase I trial for a second Nectin-4 ADC. We view this as an important target and having two compounds in the clinic provides more opportunities to improve outcomes for patients. We've also initiated a Phase I trial for our ADC targeting the folate receptor. This asset, which came from our acquisition of Mablink is the next-generation construct design -- efficacy at all fully receptor expression levels and with an improved therapeutic index relative to existing agents.

在早期腫瘤學領域，我們已經啟動了第二個 Nectin-4 ADC 的 I 期試驗。我們認為這是一個重要的目標，在臨床上使用兩種化合物可以為改善患者的治療結果提供更多機會。我們也啟動了針對葉酸受體的 ADC 的 I 期試驗。這項資產來自我們對 Mablink 的收購，是下一代建構設計——在所有完全受體表現層面上均有效，並且相對於現有藥物具有改進的治療指數。

We're also announcing that we've terminated the LOXO 783 program, which targeted PI3 kinase alpha. We evaluated the ongoing clinical data from the program and compared the molecule to next-generation candidates that we have progressed from our discovery efforts. We believe our next molecules have greater potential to benefit patients and we look forward to putting our next candidate into the clinic in 2025 and sharing more about its profile later this year.

我們也宣布我們已經終止了針對 PI3 激酶 α 的 LOXO 783 計劃。我們評估了該計畫正在進行的臨床數據，並將該分子與我們在發現工作中取得的下一代候選藥物進行了比較。我們相信我們的下一個分子具有更大的潛力使患者受益，我們期待在 2025 年將我們的下一個候選分子投入臨床，並在今年稍後分享更多有關其概況的信息。

In immunology, we've now submitted mirikizumab for the treatment of moderately to severely active Crohn's disease in Japan. We've terminated development for our GITR agonist, antagonists due to insufficient efficacy.

在免疫學方面，我們現已在日本提交了用於治療中度至重度活動性克隆氏症的 mirikizumab。由於功效不足，我們已經終止了 GITR 激動劑和拮抗劑的開發。

We also announced our acquisition of Morphic. And pending completion of the deal we plan to reflect the oral alpha-4-beta-7 integrin inhibitor, MORF-057, in Phase II for ulcerative colitis and Crohn's disease.

我們也宣布收購 Morphic。在交易完成之前，我們計劃將口服 α-4-β-7 整合素抑制劑 MORF-057 納入治療潰瘍性結腸炎和克隆氏症的 II 期臨床。

Finally in neuroscience, our anti-tau small molecule OGA inhibitor, recently concluded its Phase II study in early symptomatic Alzheimer's disease. OGA failed to meet the primary endpoint of decreasing the change of baseline as measured by -- in either of the two dose levels tested. We're reviewing the data for presentation of detailed results of the study at the clinical trials in Alzheimer's conference later this year. While this negative outcome is disappointing, we remain committed to TAP as a high conviction target in Alzheimer's disease and plan to continue studying Taobao.

最後，在神經科學領域，我們的抗 tau 小分子 OGA 抑制劑最近完成了早期症狀性阿茲海默症的 II 期研究。 OGA 未能達到減少基線變化的主要終點（在所測試的兩個劑量水平中的任何一個中）。我們正在審查數據，以便在今年稍後的阿茲海默症會議的臨床試驗中展示該研究的詳細結果。雖然這一負面結果令人失望，但我們仍然致力於將 TAP 作為阿茲海默症的高度確信目標，並計劃繼續研究淘寶。

I'll now turn the call back to Dave for closing remarks.

現在我將把電話轉回給戴夫，讓他致閉幕詞。

Thanks, Dan. Before we go to Q&A, let me briefly sum up our progress in the second quarter. Exceptional revenue growth in Q2 was driven by Mounjaro, Zepbound and Verzenio. We are pleased with the ramp in production in the first half of the year and expect continued expansion ahead.

謝謝，丹。在進行問答之前，我先簡單總結一下我們第二季的進展。第二季營收的出色成長是由 Mounjaro、Zepbound 和 Verzenio 推動的。我們對上半年產量的成長感到滿意，並預計未來將繼續擴張。

Significant advances in our pipeline include the approval of Kisunla for Alzheimer's disease, the submission of tirzepatide for moderate to severe obstructive sleep apnea and obesity in the US and Europe and positive results from the Phase III study of tirzepatide for heart failure with preserved injection fraction and obesity.

我們的產品線取得了重大進展，包括批准用於治療阿茲海默症的Kisunla、在美國和歐洲提交用於治療中重度阻塞性睡眠呼吸中止症和肥胖症的替澤帕肽，以及保留注射分數和用於治療心臟衰竭的替澤帕肽III 期研究的積極結果。

We are investing in product launches, the advancement of our pipeline as well as our ambitious manufacturing expansion agenda. All of this and the incredible work of our teams around the world give Lilly leadership confidence that we have a very bright future ahead and better opportunity than at any time in our company's history to impact human health on a global scale.

我們正在投資於產品發布、產品線的進步以及雄心勃勃的製造擴張議程。所有這些以及我們在世界各地的團隊所做的令人難以置信的工作使禮來領導層充滿信心，相信我們擁有非常光明的未來，並且有比我們公司歷史上任何時候都更好的機會在全球範圍內影響人體健康。

Now I'll turn the call over to Joe to moderate the Q&A session.

現在我將把電話轉給喬來主持問答環節。

Thanks, Dave. We'd like to take questions from as many callers as possible and to conclude our call in a timely manner. (Operator Instructions) So Paul, please provide the instructions for the Q&A, and 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，並及時結束我們的通話。 （操作員說明）保羅，請提供問答說明，我們已準備好迎接第一個來電者。 。

(Operator Instructions) And the first question today is coming from Seamus Fernandez from Guggenheim.

（操作員說明）今天的第一個問題來自古根漢的 Seamus Fernandez。

And just I'll stick with my one question. It really is on your awareness of ASP movements in the market, so the average selling price. By our calculations, when we sort of look at the ASP averages, removing rebates, inventory, et cetera, relative to comments made yesterday on Novo's call, I'm just trying to get a better understanding of what you're seeing in the market with regard to average selling price. The prices look actually reasonably close to us with the tirzepatide franchise having higher sort of ASP per script, but not dramatically higher given concerns of real pricing deterioration.

我只會堅持我的一個問題。這實際上取決於您對市場 ASP 趨勢的了解，以及平均售價。根據我們的計算，當我們查看平均售價（剔除回扣、庫存等）時，相對於昨天在 Novo 電話會議上發表的評論，我只是想更好地了解您在市場上看到的情況關於平均售價。價格看起來實際上相當接近我們，因為替西帕肽特許經營權的每個腳本的平均售價較高，但考慮到實際價格惡化的擔憂，價格並沒有大幅提高。

I guess the only question that I have here is, what are you seeing from an ASP perspective? And do you see this as kind of a natural evolution of this market as competition emergence as we saw with Ozempic historically and Trulicity in 2019?

我想我在這裡唯一的問題是，您從 ASP 的角度看到了什麼？您是否認為這是該市場作為競爭出現的自然演變，正如我們在歷史上的 Ozempic 和 2019 年的 Trulicity 中所看到的那樣？

Thanks, Seamus. I think I'll go to Gordon. Do you want to touch on that, or Patrick?

謝謝，西莫。我想我會去戈登。你想談談這個嗎，還是派崔克？

Sure. I'll hang -- with that. Seamus, thanks for the question. Yes. So just on price streams, initial favorability in the first half of the year was driven by Mounjaro. That goes away in the second half of the year as the co-pay program moves out of the base period.

當然。我會堅持下去——就這樣。西莫，謝謝你的提問。是的。因此，就價格流而言，上半年最初的好感度是由 Mounjaro 推動的。隨著共同支付計畫結束基期，這種情況將在今年下半年消失。

In terms of pricing, we see stable pricing sequentially across quarters in '24. So nothing unusual, Q1 to Q2 and our guidance Q3 and Q4 continue stable sequential pricing.

在定價方面，我們看到 24 年各季度的定價連續穩定。因此，沒有什麼異常，第一季到第二季以及我們的指引第三季和第四季繼續穩定的連續定價。

For the second half of the year when you don't have the Mounjaro dynamic pricing in the second half will be similar to prior year pricing. So those are kind of the dynamics we see in pricing.

下半年，當您沒有 Mounjaro 動態定價時，下半年的定價將與去年的定價類似。這些就是我們在定價上看到的動態。

Terence Flynn from Morgan Stanley.

摩根士丹利的特倫斯弗林。

Congrats on all the progress on the manufacturing. Maybe just a two-part for me on that one. Just wondering if you're unit guidance for the at least 1.5-fold increase in sellable doses include the Zepbound bound star vials that you're rolling out in the US or if that's a potential driver of upside?

祝賀製造方面的所有進展。也許對我來說這只是兩個部分。只是想知道您的單位指導是否將可售劑量增加至少 1.5 倍，包括您在美國推出的 Zepbound 綁定星形小瓶，或者這是否是上漲的潛在驅動力？

And then as we think about RTP, I know you continue to make progress there. The scripts suggests you're at about one-third of the way through the ramp to peak. But this inventory restock that you talked about today suggests maybe more of a meaningful step-up. So just can you quantify for us where you are in the ramp in RTP?

然後，當我們考慮 RTP 時，我知道您在這方面繼續取得進展。腳本顯示您正處於到達峰值的大約三分之一的位置。但您今天談到的庫存補充表明，這可能是更有意義的升級。那麼您能否為我們量化一下您在 RTP 中處於哪個階段？

Yes, sure. I think, Dave, do you want to hop in and --

是的，當然。我想，戴夫，你想跳進去——

Yes, I can just can -- So I think what we're saying today is just reiterating the 1.5 is sort of like a floor on how we think about second half volume. I would say the vials are part of that. But given the -- we have about 20 weeks left in the year. So there's a limit to how much of that will ship anyway. But they certainly open up a node of the most constrained part of the supply chain, which is still finish in the final container closure and it uses different lines obviously, than syringes or cartridges.

是的，我可以——所以我認為我們今天所說的只是重申 1.5 有點像我們對後半卷的看法的下限。我想說的是小瓶子是其中的一部分。但考慮到——今年還剩下大約 20 週。因此，無論如何，運送的數量是有限的。但它們確實打開了供應鏈中最受限制的部分的一個節點，該節點仍然在最終的容器封閉中完成，並且它使用的生產線顯然與注射器或藥筒不同。

So it just adds to our capacity, probably the most meaningful part of that will show up in the early '25 to be honest, as that new form ramps and details on that rollout will be coming in the coming weeks.

因此，它只是增加了我們的能力，說實話，其中最有意義的部分可能會在 25 年初出現，因為新形式的升級和推出的細節將在未來幾週內公佈。

As it relates to RTP, I wouldn't read through that the Q2 step-up in volume we shipped was primarily to RTP. That site is on track, and we are steadily escalating production per our goals. I also mentioned Concord is doing well against its time schedule, and we expect product out of that site end of this year, early next year. But rather, maybe performance out of the totality of the network that allowed us to recover wholesaler inventory levels in Q2 and now come off the FDA shortage list. It's more just overall performance across many, many nodes of our supply network.

由於它與 RTP 相關，我不會仔細閱讀我們出貨量的第二季成長主要是 RTP。工廠正在步入正軌，我們正在按照我們的目標穩步提高產量。我還提到 Concord 在其時間表上表現良好，我們預計該網站的產品將在今年年底明年初推出。相反，也許是整個網路的表現讓我們在第二季度恢復了批發商的庫存水平，現在已經脫離了 FDA 的短缺清單。它更重要的是我們供應網路中許多節點的整體效能。

Chris Schott from JPMorgan.

摩根大通的克里斯·肖特。

And congrats all the progress. There seems to be a broader debate on the role emerging earlier-stage competition in the obesity market could play where that fits in the market broadly. I'm sure you're not surprised by the breadth of agents being developed in the space. But just interested in your latest views in terms of barriers to entry you see for some of these newer competitors and how you think about defending Lilly's market position over time?

並祝賀所有的進展。關於肥胖市場中新興的早期競爭在廣泛適合市場的情況下可能發揮的作用，似乎存在更廣泛的爭論。我相信您對該領域正在開發的代理的廣度並不感到驚訝。但只是對您對這些新競爭對手的進入障礙的最新看法感興趣，以及您如何考慮隨著時間的推移捍衛禮來公司的市場地位？

Maybe, Dan, do you want to start on that? And then --

也許，丹，你想開始嗎？進而 -

Yes, I'll start some R&D comments on [BarCentry]. The first, I think, is having a successful drug in Phase III clinical trials and getting it approved. You can see that we've invested thoroughly, I would say, in our Phase III portfolio is often pursuing multiple indications in multiple populations at once. Just being able to get to that point, I know investors have gotten excited about various releases of Phase I data. But it's still a challenging space to develop drugs and we usually wait until we've seen pretty robust Phase II data before we get too excited about a particular molecule. So that's the first thing.

是的，我將在 [BarCentry] 上開始一些研發評論。我認為，第一個是在 III 期臨床試驗中獲得成功的藥物並獲得批准。我想說，你可以看到我們在我們的 III 期投資組合中進行了徹底的投資，通常是同時在多個人群中尋求多種適應症。能夠達到這一點，我知道投資者對第一階段數據的各種發布感到興奮。但藥物開發仍然是一個充滿挑戰的領域，我們通常會等到看到相當可靠的第二期數據後才會對某個特定分子過於興奮。這是第一件事。

And I think a lot of the news we've seen from different companies only sort out as we get to see Phase II data and which molecules make it and which have the right profile and which don't. But I wouldn't be expecting 100% success here.

我認為我們從不同公司看到的許多新聞只有在我們看到第二階段資料以及哪些分子製造它、哪些具有正確的特徵、哪些不具有正確的特徵時才能整理出來。但我並不期望這裡能 100% 成功。

A few additional comments. I think when we look at the marketplace, about two are very important barriers. We have been extremely successful in gaining access across both Mounjaro, where we are currently 93% access in commercial and 89% in Part D. And similarly, for Zepbound, [83%] after 7 months in the marketplace, that's quite significant.

一些補充評論。我認為當我們審視市場時，大約有兩個非常重要的障礙。我們非常成功地獲得了Mounjaro 的訪問權，目前我們在商業領域的訪問率為93%，在D 部分的訪問率為89%。 ]，這非常重要。

The second piece is the amount of -- indications. We are investing heavily in both Mounjaro and Zepbound, and similarly for the Phase III assets of our -- retatrutide. So I think, overall, we think that we are extremely well positioned to compete here. And we are not surprised to see that most of the firms are actually leaning into this very important space. But with the cost we have not had in the market today, the Phase III assets and what we referred in the prepared remarks, we are well positioned to compete today and tomorrow. And that -- both different indications, assets -- therapy, et cetera, all hands on deck on our side.

第二部分是適應症的數量。我們對 Mounjaro 和 Zepbound 進行了大量投資，對我們的瑞他魯肽的 III 期資產也進行了類似的投資。所以我認為，總的來說，我們認為我們處於非常有利的位置來參與競爭。我們毫不驚訝地發現大多數公司實際上都在傾向於這個非常重要的領域。但憑藉我們今天市場上沒有的成本、第三期資產以及我們在準備好的評論中提到的內容，我們已經做好了今天和明天的競爭準備。而且──兩種不同的適應症、資產──治療等等，我們所有人都齊心協力。

Maybe one last thing -- follow-on. But here, we're highlighting our (inaudible) [11] assets, all different targets. And maybe just a reminder, Chris, we had our Phase I MAD data for tirzepatide in 2016, that was 8 years ago. And that's a massive lead, I think, over other GIP, GLP agonists that are behind us.

也許最後一件事——後續。但在這裡，我們強調我們的（聽不清楚）[11] 資產，所有不同的目標。也許只是提醒一下，克里斯，我們在 2016 年獲得了替西帕肽的 I 期 MAD 數據，那是 8 年前的事了。我認為，與落後於我們的其他 GIP、GLP 激動劑相比，這是一個巨大的領先優勢。

On the oral side, you can get more in category differentiation based on target engagement, safety profile, et cetera. But here, again, we have the most advanced program, and as Dan highlighted today, a follow-on program to add to that sort of portfolio we have there.

在口頭方面，您可以根據目標參與、安全狀況等獲得更多類別差異化。但在這裡，我們再次擁有最先進的計劃，正如丹今天所強調的那樣，這是一個後續計劃，可以添加到我們在那裡的此類投資組合中。

And finally, one other, I don't know if it's barrier, but certainly is work to do is scaling manufacturing. The volume is really high in this category, probably will end up being one of the highest volume categories in the history of the industry. And you're talking about making things on the $1 billion scale, which takes time and it's technically difficult and very capital intensive. So of course, competitors will come. But there's a road ahead for all these that -- the two leading companies have already walked in large part.

最後，我不知道這是否是障礙，但肯定要做的工作是擴大製造規模。該類別的銷量確實很高，可能最終會成為該行業歷史上銷量最高的類別之一。你說的是製造 10 億美元規模的產品，這需要時間，技術上很困難，而且資本密集。所以當然，競爭對手也會來。但所有這些還有一條路要走——兩家領先的公司已經走了大部分。

Tim Anderson from Wolfe Research.

沃爾夫研究中心的蒂姆·安德森。

I have a question on compounders of GLP-1s, including, but not limited to, your tirzepatide. So companies like IMS or anyone else. How can this not infringe patent protection? And is this something that is likely to get adjudicated in the courts, meaning the you and presumably Novo, too? So an article just yesterday in New York Times talked about patients getting upside down with compounded GLP-1s. I think they used the term overdosing on these compounded formulations. So not only do compounders take away sales from you guys, but it could also turn -- reputation of the class. So what can we expect Lilly to do about it?

我有一個關於 GLP-1 複合物的問題，包括但不限於你們的替澤帕肽。因此，像 IMS 或其他任何公司這樣的公司。這怎麼可能不侵犯專利保護？這是否可能會在法庭上得到裁決，這意味著你，大概也包括 Novo？因此，昨天《紐約時報》上的一篇文章談到了患者服用複合 GLP-1 後出現倒立的情況。我認為他們在這些複合製劑上使用了“過量”這個術語。因此，複合材料不僅會奪走你們的銷量，而且可能會改變班級的聲譽。那麼我們可以期待禮來公司對此採取什麼措施呢？

Thanks, Tim. Dan, you want to start with some comments?

謝謝，蒂姆。丹，你想先發表一些評論嗎？

Yes. Thanks for raising this important topic, Tim. Of course, we've been watching this carefully, not really out of concern that they're taking away our business. As you know, we've been largely supply constraint here, but rather the impact it's having on patient health.

是的。感謝蒂姆提出這個重要的主題。當然，我們一直在仔細觀察這一情況，並不是真的擔心他們會搶走我們的業務。如您所知，我們在很大程度上受到供應限制，但更重要的是它對患者健康的影響。

We often are able to secure samples from these kinds of compounding labs and analyze them in our own labs. And what we found for the most part, in most instances is this isn't kind of tirzepatide at all. Our drug is not available to compounders, rather they're purchasing either other chemicals entirely, which we often find or make producers of tirzepatide that is often full of impurities sometimes contaminated by bacteria.

我們通常能夠從此類複合實驗室獲取樣品並在我們自己的實驗室中進行分析。我們發現，在大多數情況下，這根本不是一種替西帕肽。我們的藥物不提供給複合商，而是他們完全購買其他化學品，我們經常發現或製造替西帕肽的生產商，這些化學品通常充滿雜質，有時被細菌污染。

This is a safety risk to patients that we take seriously and try to think we can to make patients aware of the potential dangers here so that we can help .

這對患者來說是一個安全風險，我們會認真對待，並努力讓患者意識到這裡的潛在危險，以便我們可以提供幫助。

Yes. And just from a policy standpoint, I mean, you can expect us to be active here. We've taken public positions. We're obviously engaged with regulators and considering all kinds of legal actions and filed some.

是的。我的意思是，僅從政策角度來看，您可以期待我們在這裡表現活躍。我們已經採取了公開立場。顯然，我們正在與監管機構合作，考慮採取各種法律行動，並已提起一些訴訟。

Of course, compounding is a long-standing practice under the 503A provisions of FDA, which is meant to customize doses for individual patient needs that we don't -- it's not clear to me medically what that would be for tirzepatide. But I guess that's legal in a sense. It's the mass production that's concerning. And we don't see a lot of that with our medicine more with the other one. But I think if we just step back and reflect them why the -- there's shortages because of parenteral manufacturing constraints in the industry and the lead companies.

當然，根據FDA 503A 規定，複方是一種長期存在的做法，其目的是根據個別患者的需要定制劑量，而我們卻沒有——從醫學上來說，我不清楚這對於替西帕肽來說意味著什麼。但我想這在某種意義上是合法的。值得關注的是大規模生產。我們的藥物中並沒有看到很多這樣的情況，而另一種藥物則沒有看到很多這樣的情況。但我認為，如果我們退後一步，反思為什麼會出現短缺，因為行業和領先公司的注射製造限制。

A lot of that constraint is investing and proving those processes are compliant with the GMP standards that the FDA and Europe or NX1 have enforced. And we agree, by the way, with that strict enforcement.

其中很大一部分限制是投資並證明這些流程符合 FDA 和歐洲或 NX1 強制執行的 GMP 標準。順便說一句，我們同意嚴格執行。

So it's a little odd that the answer to that constraint, which is about raising the standards of the industry to a sterile product is to create another industry that is non-sterile product. So we're just pointing that out. And I think you can see Lilly on the front foot here over the coming months to address this.

因此，對於該限制的答案（即提高無菌產品的行業標準）的答案是創建另一個非無菌產品的行業，這有點奇怪。所以我們只是指出這一點。我認為你可以看到禮來公司在未來幾個月將積極解決這個問題。

But ultimately, the real thing to address is the increasing coverage on insurance and increasing supply. We -- drive on supply. We'll step that up another notch with the availability of vials, and we need to work with primarily the government as well as employers to expand coverage. So OBC medicines are affordable. People when we get to those points, this will be an issue. But in the meantime, people can get hurt. And as Dan said, it's pretty concerning what's happening.

但最終，真正需要解決的是保險覆蓋範圍的擴大和供應的增加。我們——以供應為動力。我們將透過提供小瓶來將這一目標提升到另一個水平，我們需要主要與政府和雇主合作以擴大覆蓋範圍。因此 OBC 藥物價格實惠。當我們達到這些點時，這將是一個問題。但同時，人們可能會受傷。正如丹所說，正在發生的事情非常令人擔憂。

Umer Raffat from Evercore.

來自 Evercore 的 Umer Raffat。

I want to ask on operating leverage, if I may. I know in the first quarter, when you guys raised the guidance by $2 billion on top line, it dropped down to EPS by $1.30. This quarter, guidance went up by $3 billion, but it dropped down at a much higher leverage at $2.16 EPS, almost a 90% incremental margin. And my question is not so much what your operating leverage is going to be in 2025 or a forward year guidance. But instead, I'm basically asking if you annualize the momentum of your 4Q numbers per this year's guidance, the EPS upside implied to consensus could be almost as much as half of Lilly's entire full year EPS where it stands right now.

如果可以的話，我想問一下經營槓桿。我知道在第一季度，當你們將營收指引提高了 20 億美元時，每股盈餘下降了 1.30 美元。本季度，指引增加了 30 億美元，但在每股收益 2.16 美元的較高槓桿下有所下降，增量利潤率幾乎達到 90%。我的問題並不是你們 2025 年的營運槓桿或未來一年的指導。但相反，我基本上是在問，如果您根據今年的指引將第四季度數據的勢頭年化，共識所暗示的每股收益上漲可能幾乎相當於禮來公司目前全年每股收益的一半。

So I'm just trying to think through, how do you plan on spending on various functions and what the incremental margins could look like as the revenue momentum really kicks in with the improving supply?

因此，我只是想思考一下，您計劃如何在各種功能上進行支出，以及隨著供應量的改善，收入動力真正發揮作用，增量利潤會是什麼樣子？

Thanks, Umer. There's a lot of financial mechanics. So I'll hand to Gordon to comment on, I think, effectively capital allocation considerations.

謝謝，烏默。有很多金融機制。因此，我認為，我將請戈登評論有效的資本配置考量。

Good. Thanks. Appreciate the question. Yes, I mean, we've been speaking for a long time about operating margins and getting to the mid- to high 30% range. As we've seen this year, Mounjaro and Zepbound are taking an inflection point upwards and so we're seeing ourselves at the top end of that range.

好的。謝謝。感謝這個問題。是的，我的意思是，我們長期以來一直在談論營業利潤率以及達到 30% 的中高水平。正如我們今年所看到的，Mounjaro 和 Zepbound 正在採取向上的拐點，因此我們認為自己處於該範圍的頂端。

For the first half, margins are a little inflated. We haven't yet lend in to all of our promotional channels and incretins. You don't see, for instance, TV commercials in the incretins. We haven't done that looking at the -- given the supply situation. And in R&D, it takes time to scale R&D thoughtfully. So it doesn't always move exactly in sync quarter-by-quarter with revenue.

上半年，利潤率有點高。我們尚未向所有促銷管道和腸促胰素提供貸款。例如，您不會在電視廣告中看到腸促胰島素。考慮到供應情況，我們還沒有這樣做。在研發方面，需要時間深思熟慮地擴大研發規模。因此，它並不總是與收入按季度完全同步。

That said, our guidance for the year does indicate we will stay in the upper 30% range for the full year, with growth first half, if you look at the first half, as the 2 quarters' growth into the second half. And you should also expect to see within that mix, stronger sales and marketing growth as we get to new launches in the second part of the year and the R&D continue to scale the growth from what we've seen thus far. So those are the dynamics we see on operating margin for 2024.

也就是說，我們對今年的指導確實表明我們全年將保持在 30% 以上的範圍內，上半年會出現增長，如果你看一下上半年，就像下半年兩個季度的增長一樣。您還應該期望在這種組合中看到更強勁的銷售和行銷成長，因為我們將在今年下半年推出新產品，並且研發將繼續擴大我們迄今為止所看到的成長。這些就是我們看到的 2024 年營業利益率的動態。

The next question will be from Mohit Bansal from Wells Fargo.

下一個問題將由富國銀行的 Mohit Bansal 提出。

Congrats on the quarter. My question is regarding the rest of the world sales for incretins. It seems like Mounjaro is doing quite well there. And if I take out the -- like 15% or so for stocking in the US, it seems like ex-US is already about 33% this early in the launch. So I would love to understand how has been your experience so far? And is there going to be any different uptake for ex-US versus your prior generation incretins for both Mounjaro and Zepbound given that these are really efficacious drugs?

恭喜本季。我的問題是關於世界其他地區腸促胰島素的銷售情況。看來Mounjaro 在那裡做得很好。如果我去掉大約 15% 左右的美國庫存，那麼在推出之初，美國以外的庫存似乎已經達到了 33% 左右。所以我很想了解到目前為止您的經驗如何？考慮到 Mounjaro 和 Zepbound 都是真正有效的藥物，美國前的腸促胰島素和上一代腸促胰島素的吸收率是否會有所不同？

Yes. Thanks, Mohit, for the question. Ilya, do you want to comment on OUS rollout for Mounjaro?

是的。謝謝莫希特提出的問題。 Ilya，您想對 Mounjaro 的 OUS 推出發表評論嗎？

Sure. Thanks, Mohit, for the question. We've seen some great progress with the launch of Mounjaro outside of the US I think what you've seen in terms of growth in the earlier launch countries, such as the UK, UAE and Saudi, UAE and Saudi are both key markets that make up rest of world, have already achieved a leading share and continue to drive momentum and overall market growth.

當然。謝謝莫希特提出的問題。隨著 Mounjaro 在美國以外地區的推出，我們看到了一些巨大的進展，我認為您所看到的早期發布國家的增長情況，例如英國、阿聯酋和沙特，阿聯酋和沙特都是關鍵市場，與世界其他地區相比，已經取得了領先的份額，並繼續推動動力和整體市場成長。

And so as you take a look at Q2, the main driver of that growth has been in Mounjaro in markets where we've already launched earlier in the cycle and majority of that coming from the Quick Pen presentation with a lot of that in the UAE. Some of that is channel dynamics similar to the US At the same time, if you take a look at Q2 and the trajectory for Q2 relative to historical peak sales of any of our brand, has already surpassed that with a limited number of markets where we've launched.

因此，當你看一下第二季時，這種成長的主要驅動力是 Mounjaro，我們已經在周期的早期推出了這些市場，其中大部分來自 Quick Pen 演示，其中許多來自阿聯酋。其中一些是與美國類似的通路動態。 。

And so as we look at the coming quarters, obviously, we just recently launched in Germany and now also Spain with Quick Pen presentation. We'll also look and monitor the demand and also supply capacity and expect to launch in new markets. The near-term growth, I would expect predominantly coming from already launched markets of Mounjaro.

因此，當我們展望未來幾個季度時，顯然，我們最近剛在德國和西班牙推出了 Quick Pen 演示。我們還將關注和監控需求和供應能力，並預計在新市場推出。我預期近期成長主要來自 Mounjaro 已經推出的市場。

Alex Hammond from Bank of America.

美國銀行的亞歷克斯·哈蒙德。

In the prepared remarks, Dan mentioned engagement with regulatory authorities on a potential pivotal trial in NASH. Can you provide any color on these discussions and how Lilly is thinking about tirzepatide versus -- for this indication? When could we receive updates?

在準備好的發言中，Dan 提到與監管機構就 NASH 的潛在關鍵試驗進行合作。您能否提供有關這些討論的任何資訊以及禮來公司如何考慮替澤帕肽與該適應症的比較？我們什麼時候可以收到更新？

Dan?

擔？

Yes. Thanks for the question. We're really excited about the opportunity to help patients suffering from NASH. I think the data that we shared in Phase II for tirzepatide appetite is really quite profound in terms of the size of effect we can have.

是的。謝謝你的提問。我們非常高興有機會幫助 NASH 患者。我認為我們在第二階段分享的有關替西帕肽食慾的數據對於我們可以產生的影響的大小來說確實非常深刻。

There's a couple of issues in mass drug development that we're trying to tackle, probably the most significant of which is current standard of liver biopsy to identify the patients to enroll in these trials and also then measure the outcome. Liver biopsy is obviously an invasive procedure and difficult to find patients to consent to these trials and of course, there's risk to patients.

我們正在努力解決大規模藥物開發中的幾個問題，其中最重要的可能是目前的肝臟活檢標準，以確定參加這些試驗的患者，然後測量結果。肝臟切片檢查顯然是一種侵入性手術，很難找到同意這些試驗的患者，當然，患者也存在風險。

We're working hard to develop noninvasive biomarkers that can be used to identify the right patients to enroll in mass studies and also potentially could be used as an outcome to know if a drug is working.

我們正在努力開發非侵入性生物標記物，這些標誌物可用於識別合適的患者參與大規模研究，也有可能用作了解藥物是否有效的結果。

My hope is that we could develop those kinds of biomarkers that could be used both purposes and could be suitable for accelerated or approval of mass drugs in the future.

我的希望是，我們能夠開發出可用於這兩種目的的生物標記物，並且適合未來加速或批准大規模藥物。

Of course, long-term traditional approval for Astra still requires demonstration of outcomes. So in that environment, we have two drugs that I think could both be great mass drugs and we'll have to decide whether to invest in one or both of those drugs, depending on the regulatory path we see. We'll keep investors updated as we make decisions about these molecules in mesh.

當然，Astra 的長期傳統批准仍然需要結果證明。因此，在這種環境下，我們有兩種藥物，我認為它們都可能成為大眾藥物，我們必須根據我們看到的監管路徑來決定是否投資其中一種或兩種藥物。當我們對網格中的這些分子做出決定時，我們將隨時向投資者通報最新情況。

Evan Seigerman from BMO Capital Markets.

BMO 資本市場部的 Evan Seigerman。

I wanted to touch on manufacturing and specifically, on the concern that you raised back in February around the proposed acquisition of Catalent by Novo Holdings and the subsequent sale to Novo Nordisk. Are you still as concerned as you were in February? Or given what you've been able to do with your own footprint? Is this less of an issue?

我想談談製造業，特別是您在 2 月提出的有關 Novo Holdings 擬收購 Catalent 以及隨後出售給 Novo Nordisk 的擔憂。你還像二月那樣擔心嗎？或者考慮到您已經能夠用自己的足跡做些什麼？這不是一個小問題嗎？

Yes, I can take it. We remain concerned about that transaction. I don't think it was ever really about the trajectory of our ramp, although as we've disclosed, we do rely on one of the Catalent sites for GLP-1 and other diabetes production. It's more the oddity of your main competitor being also your contract manufacturer and how to resolve that situation.

是的，我可以接受。我們仍然對該交易感到擔憂。我認為這與我們的產能成長軌跡無關，儘管正如我們所揭露的，我們確實依賴康泰倫特工廠之一來生產 GLP-1 和其他糖尿病藥物。更奇怪的是，你的主要競爭對手同時也是你的合約製造商，以及如何解決這種情況。

There's also an industry structure issue. CDMOs are important for managing capacity across the sector. And if we ended up in an outcome where that sector didn't really exist, they all became captive of large pharma would really constrain, I think, availability in the development of medicines, particularly out of biotech. So we've aired those concerns publicly and privately since the proposed transaction was announced, and we're waiting to see what happens.

還有一個產業結構問題。 CDMO 對於管理整個產業的能力非常重要。如果我們最終得出的結果是該部門並不真正存在，那麼它們都將成為大型製藥公司的俘虜，我認為，這將真正限制藥物開發的可用性，特別是生物技術藥物的開發。因此，自從擬議的交易宣布以來，我們已經公開和私下表達了這些擔憂，我們正在等待看看會發生什麼。

But in terms of the long-term outlook for our company, as you may have noticed, we're building aggressively ourselves. Our primary strategy is self-run sites. And we've got $18 billion we've announced in the last several years, probably not done there. And we're quite comfortable building operating sites and as the newest large sites of begun to come online, we know we can execute that drill and repeat it, and that's our base plan.

但就我們公司的長期前景而言，正如您可能已經注意到的，我們正在積極建立自己。我們的主要策略是自營網站。過去幾年我們宣布了 180 億美元，但可能還沒完成。我們非常輕鬆地建立營運站點，隨著最新的大型站點開始上線，我們知道我們可以執行該演習並重複它，這就是我們的基本計劃。

Dave Risinger from Leerink.

來自 Leerink 的 Dave Risinger。

Let me add my congrats on the results as well and the corporate updates. So Zepbound's breadth of health and work or productivity benefits seem to be underappreciated by many. There are articles from time to time, let's say, that patients need an off-ramp from therapy, et cetera. And my question is, what is Lilly doing to encourage patients to stay persistent with therapy? And how does Lilly intend to better communicate not just Zepbound's health benefits, but its worker productivity benefits to employers in order to drive much greater employer inclusion of obesity drugs as part of employee benefits?

讓我對結果和公司更新表示祝賀。因此，許多人似乎低估了 Zepbound 在健康、工作或生產力方面的廣泛益處。時不時會有一些文章說，患者需要退出治療，等等。我的問題是，禮來公司正在採取哪些措施來鼓勵病人堅持治療？禮來公司打算如何更好地向雇主傳達 Zepbound 的健康益處以及其對工人生產力的益處，以推動雇主更多地將肥胖藥物納入員工福利的一部分？

Thanks, Dave. Patrik, do you want to comment on persistency and benefits?

謝謝，戴夫。 Patrik，您想對持久性和好處發表評論嗎？

Absolutely. I think first overall, when we look at persistency, it's very early after the launch. But based on the feedback we have from providers, and from patients as well, this is a drug that patients want to stay on because they experience the benefits -- weight loss and also the downstream implications on comorbidities.

絕對地。我認為首先，當我們考慮持久性時，現在還處於發布後的早期階段。但根據我們從提供者和患者那裡得到的回饋，患者希望繼續使用這種藥物，因為他們體驗到了好處——體重減輕以及對合併症的下游影響。

You're right, the employee opt-in efforts are extremely key, and we believe that our outcome data, OSA, now have -- will help us tremendously and more readout to come over the coming years. We're also having value-based agreement with several other payers where we are looking into the benefits of tirzepatide in the workplace in terms of reduced absentees, increased productivity, et cetera, as well and that has gained a lot of interest.

你是對的，員工選擇加入的努力非常關鍵，我們相信我們的結果數據 OSA 現在擁有的數據將極大地幫助我們，並在未來幾年提供更多的讀數。我們還與其他幾個付款人達成了基於價值的協議，我們正在研究替西帕肽在工作場所的好處，包括減少缺勤、提高生產力等，這引起了許多人的興趣。

In terms of the consumer, yes, the ease to start and stay on is a key priority for us. And then we're working with consumer, improving our consumer platforms and also digital channels to really enable patients to experience the benefits that Zepbound provides over time.

就消費者而言，是的，輕鬆開始和堅持是我們的首要任務。然後我們正在與消費者合作，改進我們的消費者平台和數位管道，以真正讓患者體驗到 Zepbound 隨著時間的推移所帶來的好處。

Kerry Holford from Berenberg.

來自貝倫貝格的凱瑞·霍爾福德。

Just coming back to the margin question earlier, given another expense in the 2024 --

回到先前的保證金問題，考慮到 2024 年的另一項支出——

Apologies team. We will get Kerry reconnected with a better line momentarily. And we'll move on to the next question, in the meantime, if that's okay from Chris Shibutani from Goldman Sachs.

道歉團隊。我們將立即為克里提供更好的線路重新連接。同時，如果高盛的 Chris Shibutani 同意的話，我們將繼續討論下一個問題。

With all the different oral mechanisms in particular, variations on it from yourselves as well as competitors, can you update us on your thinking on what the basis of competition is going to be? And what kind of opportunities do you really envision? I think there has been for a while now a comparison on the basis of percent weight loss, particularly for the injectables. But as we move into orals, it seems as if tolerability profiles really matter. So how are you thinking about it? And how do you recommend investors think when we compare datasets across these other oral products in development? Even if the mechanisms are different, how do we get smarter about differentiating and interpreting dat

特別是由於所有不同的口頭機制，您自己以及競爭對手的不同，您能否向我們介紹您對競爭基礎的最新想法？您真正設想的機會是什麼？我認為基於減肥百分比的比較已經有一段時間了，特別是對於注射劑。但當我們進入口頭階段時，耐受性似乎真的很重要。那你覺得怎麼樣？當我們比較正在開發的其​​他口服產品的資料集時，您建議投資人如何思考？即使機制不同，我們如何更聰明地區分和解釋數據

Dan, you want to chime in?

丹，你想插話嗎？

Yes. Thanks. I'll start, and then we'll see Patrik to anything to add on commercial differentiation. But in the clinical trials, I think first of all, as I'm saying before, just take some caution on the small short Phase I trials. There's more to see. Most of the drugs that we've seen actually aren't different mechanisms that are GLP-1 agonists.

是的。謝謝。我先開始，然後我們會看到派崔克做任何事情來增加商業差異化。但在臨床試驗中，我認為首先，正如我之前所說，對小型短期一期試驗要謹慎。還有更多值得一看的東西。我們所見過的大多數藥物實際上與 GLP-1 激動劑的作用機制並沒有什麼不同。

In this class, I don't expect there to be differentiation in terms of efficacy, weight loss. You can pretty much dial in the amount of weight loss you want depending on how aggressively you dose it and what population. Tolerability is another issue that usually comes along with the efficacy. The faster you ramp to higher doses, the less tolerability you have. Then the different companies have to work through their own escalation of dosing to match the desired efficacy with some reasonable tolerability.

在這個課程中，我不認為在功效、減肥方面會有差異。你幾乎可以根據你的減重力度和人群來調整你想要的減肥量。耐受性是通常伴隨療效而來的另一個問題。增加劑量的速度越快，耐受性就越差。然後，不同的公司必須透過自己的劑量升級來使所需的療效與合理的耐受性相匹配。

The variable that links those two things together is often the half-life of the molecule. So shorter half-life molecules will give you bigger peak trough -- in the pharmacokinetics of the drug. And we think that's what -- that drives the tolerability issues. So what you want is a long half-life molecule that can be dose escalated more smoothly. So that probably will be the differentiation rather than anything that companies are currently talking about in terms of efficacy.

將這兩件事連結在一起的變數通常是分子的半衰期。因此，在藥物的藥物動力學中，較短的半衰期分子會為你帶來更大的峰谷。我們認為這就是導致耐受性問題的原因。因此，您想要的是一種半衰期長、可以更平穩地增加劑量的分子。因此，這可能將是差異化，而不是公司目前在功效方面談論的任何內容。

As I said before, it's a long road from early data to Phase III clinical trials like we have with orforglipron and we can expect some attrition.

正如我之前所說，從早期數據到 III 期臨床試驗（就像我們對 orforglipron 所做的那樣）還有很長的路要走，我們可以預期會出現一些損耗。

I'm pretty excited also about next-generation molecule. All of these ones that we've been talking about now are GLP-1s and will offer efficacy sort of in the range of injectable semaglutide. I think ultimately, we'd like to see drugs that offer efficacy and tolerability that exceeds that things that could combine multiple incretins like tirzepatide does and we are certainly working on orals that could also agonize GIP-1, for example. So exciting progress there and more to come on that in the future for us.

我對下一代分子也非常興奮。我們現在討論的所有這些藥物都是 GLP-1，並且將提供注射索馬魯肽範圍內的功效。我認為最終，我們希望看到藥物的功效和耐受性超過像替澤帕肽那樣組合多種腸促胰島素的藥物，並且我們當然正在研究也可以刺激 GIP-1 的口服藥物。那裡取得了令人興奮的進展，未來我們將取得更多進展。

Just from a commercial point of view, we are regularly conducting both consumer and provider market research. And when we're looking into the preferences, the true drivers today is still the degree of weight loss and safety and tolerability. And when we look at the needs beyond that, it's actually the need of an oral, and an oral with an injectable-like efficacy. So that's probably the new that comes beyond what we're currently serving today and particularly to serve those patients that have a fear of injections.

僅從商業角度來看，我們定期進行消費者和提供者市場研究。當我們研究偏好時，當今真正的驅動因素仍然是減肥程度、安全性和耐受性。當我們考慮除此之外的需求時，實際上是需要口服劑，並且是具有註射劑功效的口服劑。因此，這可能是超越我們目前所提供服務的新服務，特別是為那些害怕注射的患者提供服務。

When we look at over aspects, I think what comes beyond that would be the compensation of weight loss, lean mass versus fats and durability. And I think we are looking into all of those aspects as well.

當我們從各個方面來看時，我認為除此之外的是對減肥、瘦體重與脂肪以及耐用性的補償。我認為我們也在研究所有這些方面。

I know we're running short on time. So we'll do our best to kind of compress our answers as we get through as many questions as possibl

我知道我們的時間不多了。因此，當我們解決盡可能多的問題時，我們將盡力壓縮我們的答案

And we have Kerry Holford from Bernberg reconnected.

來自伯恩伯格的克里·霍福德 (Kerry Holford) 重新與我們取得了聯繫。

Hopefully, you can hear me better this time around.

希望這次你能聽得更清楚。

Much better.

好多了。

Lovely. My question was on margins. So given you are now landing -- expecting to land in that mid- to high 30s range this year -- after the Zepbound launches, where can we expect your midterm operating margin plan? Is the margin in the mid-40%, perhaps higher achievable?

迷人的。我的問題是關於邊緣的。因此，考慮到您現在的目標是——預計今年將達到 30 多歲的範圍——在 Zepbound 推出後，我們可以預期您的中期營業利潤率計劃是多少？ 40%左右的利潤率，甚至更高，是否可以實現？

And Dave, I know you previously suggested that an operating margin above 40% is not sustainable from an innovation-focused company. But given your progress so far, I wonder if you've changed your view on that.

Dave，我知道您之前曾表示，對於一家專注於創新的公司來說，營業利潤率超過 40% 是不可持續的。但考慮到您迄今為止的進展，我想知道您是否改變了看法。

Gordon, do you want to touch on that briefly?

戈登，你想簡單談談這個嗎？

Will do. Thanks, Kerry. I appreciate the question. Yes. I think as we said, like dance, as I said earlier, we do expect to end in that upper 30s range this year. There's still a lot at play here. Yes, on the top line, we see inflection points on revenue. But through the first half, you've had an inflated position. We haven't yet leaned in to any of our promotional channels. That's going to be a dynamic that we lean to more starting in the second half. And R&D, we do intend to scale that, and that's not going quarter-by-quarter exactly in line with revenue.

會做。謝謝，凱瑞。我很欣賞這個問題。是的。我認為正如我們所說，就像舞蹈一樣，正如我之前所說，我們確實預計今年會達到 30 多歲的範圍。這裡還有很多事情要做。是的，在營收方面，我們看到了收入的轉捩點。但在上半場，你的部位已經膨脹了。我們還沒有使用任何促銷管道。這將是我們在下半場開始時更傾向於的動力。在研發方面，我們確實打算擴大規模，但這並不是逐季度與營收完全一致。

So all of those things are still going to play through. I think that said, at this point, we're just talking about 2024. And when we do guidance for '25, we'll chat about the longer-term picture there.

所以所有這些事情仍然會發生。我認為這就是說，目前我們只是在談論 2024 年。

The next question will be from Akash Tewari from Jefferie

下一個問題將由 Jefferie 的 Akash Tewari 提出

So we're starting to see that -- may not be the only way to kind of preserve lean muscle mass. In particular, it looks like [Amlin GLP] combos are showing the potential for maybe 90% versus 10% fat versus muscle loss. Can you talk about what you think Aloralintide to Zepbound combo could show both in terms of absolute weight loss, but also the quality of that weight loss? And then where would -- fit in a world where next-gen -- triplet could show that level of muscle preservation?

所以我們開始看到——可能不是保持瘦肌肉質量的唯一方法。特別是，[Amlin GLP] 組合似乎顯示出分別減少 90% 和 10% 脂肪和肌肉的潛力。您能否談談您認為 Aloralintide 與 Zepbound 組合在絕對減肥方面以及減肥品質方面可以表現出什麼？那麼，在下一代三聯體可以顯示出這種水平的肌肉保存的世界中，哪裡會合適呢？

Dan can focus on that first question about oral.

丹可以專注於關於口語的第一個問題。

So we have multiple mechanisms in play here, starting maybe with the amylin. We have a molecule Phase II called Aloralintide, which is a pure AML agonist, and we're evaluating that both as monotherapy and in combination with tirzepatide GLP clip. So that will be interesting to see. I don't have a strong preconceived notions about what to expect in terms of lean versus fat mass loss with that particular combination. Probably the people who have the most data about that would be the scientists at Novo since they've investigated [cricalutide] in combination with semaglutide.

因此，我們有多種機制在發揮作用，也許從胰淀素開始。我們有一種名為 Aloralintide 的 II 期分子，它是一種純 AML 激動劑，我們正在評估其作為單一療法以及與替西帕肽 GLP 剪輯的聯合療法。所以這將會很有趣。對於這種特定組合的瘦肉量與脂肪量的減少效果，我沒有強烈的先入為主的觀念。擁有最多這方面數據的人可能是 Novo 的科學家，因為他們研究了 [cricalutide] 與索馬魯肽的組合。

I think that brings us probably to another mechanism, which is dual amylin calcitonin agonism, which crugilatide probably is a dual agonist, and we have a molecule like that in Phase I called DACRA and we'll also investigate that and composition of biomass will be one of the aspects in which we evaluate it.

我認為這可能給我們帶來另一種機制，即雙重胰島澱粉樣多肽降鈣素激動劑，其中克魯吉拉肽可能是一種雙重激動劑，我們在第一階段有一個類似的分子，稱為DACRA，我們還將研究它，並且生物質的組成將是我們評估它的方面之一。

And then finally, you talk of myostatin, we have a molecule in this family, and that's the bimagrumab that we acquired from Versatis, which is an antibiotic -- and that's proceeding in a Phase II trial in combination with semaglutide. And we look forward to having data to share with that in the future.

最後，說到肌肉生長抑制素，我們在這個家族中有一個分子，那就是我們從 Versatis 獲得的 bimagrumab，它是一種抗生素，正在與 semaglutide 聯合進行 II 期試驗。我們期待將來能夠分享數據。

All of these mechanisms, I think, could have variable effects on body mass composition. I point out that so far, we've not seen any disadvantages to the types of weight loss that we get with tirzepatide. In fact, patients show improved functional outcomes on a variety of things, including fruit function and heart failures we just demonstrated. So could we have further improvements with even more higher ratio of fat to lean mass? That's the question of these trials makes

我認為，所有這些機制都可能對體重組成產生不同的影響。我指出，到目前為止，我們還沒有看到使用替澤帕肽的減肥類型有任何缺點。事實上，患者在許多方面都表現出改善的功能結果，包括我們剛剛證明的水果功能和心臟衰竭。那我們是否可以進一步改進，提高脂肪與瘦肉的比例？這就是這些試驗提出的問題

Trung Huynh from UBS.

瑞銀 (UBS) 的 Trung Huynh。

Just following on from the previous question on ex-US GLP-1. You saw Mounjaro ex-US sales this quarter jumped to $677 million from $286 million. Can you give us some color on how ex-US reimbursement is going with the bigger countries? And is this more of an out-of-pocket drug in these countries? And what percentage of the $677 million is obesity sales versus diabetes?

緊接著上一個關於前美國 GLP-1 的問題。您會看到 Mounjaro 本季美國以外的銷售額從 2.86 億美元躍升至 6.77 億美元。能為我們介紹一下美國以外的大國的報銷情況嗎？在這些國家，這更像是一種自付費用的藥物嗎？肥胖症銷售額與糖尿病銷售額在 6.77 億美元中所佔的比例是多少？

Okay. On that second one, I don't think we'll probably give much of a good answer on that. So I'll maybe ask Ilya to weigh in just on that first question around how ex-US reimbursement is going.

好的。關於第二個問題，我認為我們可能不會給出很好的答案。因此，我可能會請伊利亞（Ilya）參與討論第一個問題，即美國以外的報銷情況如何。

Sure. Well, of course, I think the momentum overall is progressing quite nicely in both the reimbursed as well as the out-of-pocket segments. We have achieved reimbursement in the UK We have reimbursement in Germany, and we're continuing to look for reimbursement and expand reimbursement in other markets that we've launched. We have some reimbursement in UAE in Saudi as well in type 2 diabetes. And we continue to expand on that in the markets that we will enter. But a lot of that momentum is covering both the Type 2 and chronically management market and both in the reimbursed and out-of-pocket segment, and we're seeing both the progress in share as well as market expansion in the markets that we've been in.

當然。嗯，當然，我認為報銷和自付費用領域的整體動能都進展得相當不錯。我們已經在英國實現了報銷，我們在德國也實現了報銷，並且我們正在繼續尋求報銷並擴大我們已推出的其他市場的報銷範圍。我們在阿聯酋、沙烏地阿拉伯以及第 2 型糖尿病方面都有一些報銷。我們將繼續在我們將進入的市場中擴展這一點。但這種勢頭很大程度上涵蓋了 2 類和長期管理市場以及報銷和自付費用領域，我們看到了我們所涉市場的份額的進步以及市場的擴張。

Thanks, Ilya. Paul, I know we have a lot in the queue. Maybe we just have two more questions and then wrap things up.

謝謝，伊利亞。保羅，我知道我們有很多人在排隊。也許我們還有兩個問題就結束了。

Steve Scala from TD Cowen.

TD Cowen 的 Steve Scala。

The FDA definition of shortage seems clear and tirzepatide no longer meeting the definition of shortage seems to imply Lilly is meeting demand. I assume you will say that that's not the case, but the definition at least in black and white is quite clear. I assume this is FDA's determination. So does Lilly agree with FDA's conclusion? How is demand being met? How is demand being measured? And what does demand look like?

FDA 對短缺的定義似乎很明確，替西帕肽不再滿足短缺的定義似乎意味著禮來正在滿足需求。我想你會說事實並非如此，但至少白紙黑字的定義是相當清楚的。我認為這是 FDA 的決定。那麼禮來公司是否同意FDA的結論呢？需求如何被滿足？如何衡量需求？需求是什麼樣的？

Yes. Thanks for the important question. As we think about the compounding question is important as well. As we've said earlier, we're available in all dosage forms in the US What that means is, as you know, we can fill orders as they receive versus what we're doing.

是的。謝謝你提出這個重要的問題。當我們思考複合問題時也很重要。正如我們之前所說，我們在美國提供所有劑型。

That does not mean that any pharmacy or certainly every pharmacy has all 12 dosage forms sitting on their shelf. That's infeasible economically probably for a lot of them and even logistically. So I think we'll continue to see because there's not an abundance of supply. It's more of a real-time fulfillment situation, patients going to pharmacy counters and being told to wait a few days while their orders filled.

這並不意味著任何藥房或每個藥房的貨架上都有所有 12 種劑型。對他們中的許多人來說，這在經濟上甚至在後勤上可能都是不可行的。所以我認為我們會繼續觀察，因為供應並不充足。這更像是一種即時履行情況，患者前往藥房櫃檯並被告知要等待幾天才能完成訂單。

But product is flowing and it's flowing at a pretty high rate. We're shipping part of it, and you can see that in these results from the quarter. So files will add to that picture, but demand will increase as well. So I think we're doing well given the situation. But the end pharmacy experience will continue to be choppy. We point that out to the FDA. So that means people may call and say, I couldn't get what I want on the moment I wanted it at the pharmacy I choose to. That's not the definition that we think applies here.

但產品正在流動，流動速度相當高。我們正在運送其中的一部分，您可以在本季度的結果中看到這一點。因此，文件將添加到該圖片中，但需求也會增加。所以我認為考慮到目前的情況我們做得很好。但最終的藥房體驗將繼續不穩定。我們向 FDA 指出了這一點。因此，這意味著人們可能會打電話說，我無法在我選擇的藥房買到我想要的東西。我們認為這不是適用於此的定義。

So we'll continue to with channel partners and the agency to try to clear up the confusion and improve the consumer experience, which is our responsibility along with theirs.

因此，我們將繼續與通路合作夥伴和代理商一起努力消除混亂並改善消費者體驗，這是我們和他們的責任。

Last question today will be from Louise Chen from Cantor.

今天的最後一個問題將由 Cantor 的 Louise Chen 提出。

I wanted to ask you how excited you are about these muscle preserving obesity drugs and if you see that as a true unmet need?

我想問您對這些保持肌肉的肥胖藥物有多興奮，您是否認為這是一個真正未被滿足的需求？

Thanks. Dan, anything to add on?

謝謝。丹，有什麼要補充的嗎？

Yes. No, thanks for the question, Lisa. I think it's an interesting area of science for sure. Too soon to know exactly how these kinds of mechanisms will translate into benefits for patients.

是的。不，謝謝你的提問，麗莎。我認為這確實是一個有趣的科學領域。現在確切地知道這些機制將如何轉化為患者的益處還為時過早。

At a high level, we know that the ratio of lean mass to fat mass is really important in determining metabolic health, probably more important as an indicator of overall metabolic health than, for example, BMI. And so that's what spurs these kinds of efforts to increase lean mass while causing fat mass loss and we'll wait to see data from our own [nimagrimab] and wait to see how that translates into health benefits for patients.

在較高層面上，我們知道去脂質量與脂肪質量的比率對於確定代謝健康非常重要，作為整體代謝健康的指標可能比 BMI 等更重要。因此，這就是刺激這些增加瘦體重同時減少脂肪量的努力的原因，我們將等待看到我們自己的 [nimagrimab] 的數據，並等待看看這如何轉化為患者的健康益處。

Great. So I think we'll wrap up. Dave, closing remarks.

偉大的。所以我想我們就結束吧。戴夫致閉幕詞。

Great. Thanks, Joe, and thanks to the team here. We appreciate your participation in today's earnings call and your interest in Eli Lilly and Company. Please follow up with the Investor Relations team if you have any questions we didn't address, and it sounds like there's a few that are holding. Happy to answer all of those. Have a great day, everyone.

偉大的。謝謝喬，也謝謝這裡的團隊。我們感謝您參加今天的財報電話會議以及您對禮來公司的興趣。如果您有任何我們未解決的問題，請與投資者關係團隊聯繫，聽起來有一些問題尚未解決。很高興回答所有這些。祝大家有美好的一天。

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 p.m. today running through September 12 at midnight. You may access the replay system at any time by dialing 800 3326854 and entering the access code 297484. International dollars can call 973 528 0005. (Operator Instructions) Thank you for your participation. You may now disconnect your lines.

謝謝。女士們、先生們，我們今天的會議到此結束。本次會議將於下午 1:00 開始重播。今天持續到 9 月 12 日午夜。您可以隨時撥打800 3326854並輸入接入碼297484訪問重播系統。現在您可以斷開線路。