禮來公司 (LLY) 2024 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2024 earnings call.

女士們先生們，感謝你們的支持，歡迎參加禮來公司 2024 年第三季財報電話會議。 （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。

(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.

Thank you, Paul, and good morning, everybody.

謝謝你，保羅，大家早安。感謝您參加禮來公司和公司 2024 年第三季財報電話會議。我是喬‧弗萊徹，投資人關係資深副總裁。

Thanks for joining us for Eli Lilly and company's Q3 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 Chair and CEO; Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology; Lucas Montarce, 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.

與我一起參加今天電話會議的還有禮來公司 (Lilly) 董事長兼執行長 Dave Ricks； Dan Skovronsky 博士，禮來免疫學首席科學官兼總裁；盧卡斯‧蒙塔斯，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 Susan Hedgelin、Michaela Irons、Mike Sprengnether 和 Lauren Zierke 也加入了我們。

We're also joined by Susan Hedglin, Michala Irons, Mike Sprengnether and Lauren Zierke of the IR team.

During this call, we anticipate making projections and forward-looking statements based on our current expectations.

在這次電話會議中，我們預計將根據我們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。

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。現在我將把電話轉給戴夫。

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.

Now I'll turn the call over to Dave.

Okay.

好的。謝謝，喬。第三季度，禮來公司的業務持續取得進展。我們實現了強勁的收入成長，我們推進並擴大了我們的產品線，我們投資於新產品的發布並持續擴大製造網路。在投影片 5 上，您可以看到我們的財務表現以及與策略交付成果相關的進展的詳細資訊。

Thanks, Joe. In Q3, Lilly continued to make progress across the business.

We delivered strong revenue growth, we advanced and expanded our pipeline, and we invested in new product launches and continued expanding our manufacturing network.

On Slide 5, you can see details of our financial performance and progress related to our strategic deliverables.

Revenue grew 42% after excluding the impact of revenue from the olanzapine portfolio, which we divested in Q3 2023.

在排除我們在 2023 年第三季剝離的奧氮平產品組合收入的影響後，收入增長了 42%。美國對 Mounjaro 和 Zepbound 的需求一直強勁，並隨著我們擴大准入和供應而持續成長。第三季美國處方藥量較上季成長 25%。所有劑量均可透過批發管道和早期直接藥房解決方案從禮來公司訂購。

New product revenue grew by over $3 billion, led by Mounjaro and Zepbound.

US demand for Mounjaro and Zepbound has been strong and continues to grow as we expand both access and supply.

US sequential quarter-over-quarter prescription volume growth was 25% in Q3.

All doses are available for order from Lilly in both the wholesale channel and LillyDirect pharmacy solutions.

The launch of a single-dose Zepbound vials in the US exclusively through LillyDirect's self-pay channel, further expanded supply and access in the quarter.

單劑量 Zepbound 小瓶僅透過 LillyDirect 的自付費管道在美國推出，進一步擴大了本季的供應和取得。最後，與去年下半年相比，我們仍有望在今年下半年超過腸促胰島素藥物銷售劑量至少 1.5 倍的生產目標。

And finally, we remain on track to exceed the production target of at least 1.5x the saleable doses of incretin medicines in the second half of this year compared to the second half of last year.

We continue to see strong performance across the balance of our portfolio in oncology, immunology, and neuroscience.

我們繼續看到我們在腫瘤學、免疫學和神經科學領域的投資組合表現強勁。剔除奧氮平產品組合的收入，該公司第三季的非腸促胰島素成長率為 17%。

Excluding revenue from the olanzapine portfolio, the non-incretin growth of the company was 17% in Q3.

We achieved several key pipeline milestones this quarter, including the approval of Ebglyss in the US for the treatment of moderate to severe atopic dermatitis, the approval of Kisunla in Japan and Great Britain for the treatment of early symptomatic Alzheimer's disease; disclosure of positive 176-week data from the SURMOUNT-1 Phase III study of tirzepatide in adults with prediabetes and obesity or overweight; and the recent presentation of positive data from the Phase III TRAILBLAZER-ALZ 6 study, evaluating different dosing regimens for donanemab.

本季我們實現了幾個關鍵的管道里程碑，包括 Eliquis 在美國獲準用於治療中度至重度異位性皮膚炎，日本和英國獲準用於治療早期症狀性阿茲海默症；披露替西帕肽治療糖尿病前期和肥胖或超重成人的 SURMOUNT-1 III 期研究的 176 週積極數據；最近公佈了 III 期 TRAILBLAZER-ALZ 6 研究的積極數據，評估了 donanemab 的不同給藥方案。

Our manufacturing expansion agenda remains a top priority.

我們的製造業擴張議程仍是重中之重。 9 月份，我們投資了近 20 億美元來擴大我們在愛爾蘭的製造足跡。這使得自 2020 年以來宣布的建設、升級和收購製造設施的承諾總額超過 200 億美元。除了這 200 億美元的承諾之外，我們還宣佈單獨投資 45 億美元來開發禮來製藥鑄造廠。

In September, we invested nearly $2 billion to increase our manufacturing footprint in Ireland.

This brings the total commitments to build, upgrade, and acquire manufacturing facilities announced since 2020 to more than $20 billion.

And beyond this $20 billion commitment, we also announced a separate $4.5 billion investment to develop the Lilly Medicine Foundry.

This first-of-its-kind facility will be dedicated to research and development for manufacturing process design and to develop high-quality investigational medicines for our clinical trials.

這個同類首個設施將致力於製造製程設計的研發，並為我們的臨床試驗開發高品質的研究藥物。它將位於印第安納州黎巴嫩，距離公司總部只有很短的車程。這項投資強調了我們對我們的產品線的信心以及我們為世界各地的患者提供創新藥物的緊迫性。

It will be located in Lebanon, Indiana, a short drive from the corporate headquarters.

This investment underscores our confidence in our pipeline [capabilities] (added by company after the call) and urgency to bring our innovative medicines to patients around the world.

In August, we closed the acquisition of Morphic Therapeutics, adding oral integrin assets to our early phase immunology portfolio.

八月，我們完成了 Morphic Therapeutics 的收購，將口服整合素資產添加到我們的早期免疫學產品組合中。最後，我們透過股利和股票回購向股東返還超過 16 億美元。

And lastly, we returned over $1.6 billion to shareholders via dividends and share repurchases.

On Slide 6, you'll see key events since our Q2 call, including the milestones I mentioned earlier and several other key updates.

在投影片 6 上，您將看到自我們第二季電話會議以來的關鍵事件，包括我之前提到的里程碑和其他幾個關鍵更新。上個月，我們任命 Lucas Montarce 為禮來公司執行副總裁兼財務長。盧卡斯在禮來公司擁有 23 年的經驗，並與執行團隊和董事會長期合作，所以恭喜盧卡斯。

Last month, we appointed Lucas Montarce as Lilly's Executive Vice President and Chief Financial Officer.

Lucas has 23 years of experience at Lilly and has worked with the executive team and the Board for a long time, so congratulations, Lucas.

Now let me turn the call over to Lucas to review our Q3 financial results and provide an update on our 2024 financial guidance.

現在讓我將電話轉給盧卡斯，回顧我們第三季的財務業績，並提供 2024 年財務指引的最新資訊。

Thanks, Dave.

謝謝，戴夫。投影片 7 總結了我們第三季的財務業績，其中突出的是我們的新產品和非腸促胰島素藥物的強勁收入成長。正如 Dave 所提到的，在排除奧氮平產品組合收入的影響後，收入成長了 42%，這主要是由 Mounjaro 和 Zepbound 推動的。

Slide 7 summarizes our financial performance in the third quarter, which is highlighted by strong revenue growth across our new products as well as our non-incretin medicines.

As Dave mentioned, revenue grew 42% after excluding the impact of revenue from the olanzapine portfolio and was primarily driven by Mounjaro and Zepbound.

Revenue from our non-incretin portfolio grew 17% after excluding the impact of revenue from the olanzapine portfolio.

在排除奧氮平產品組合收入的影響後，我們的非腸促胰島素產品組合收入成長了 17%。毛利率佔收入的百分比增加至82.2%。毛利率主要受益於有利的產品組合和更高的實現價格，但部分被 2023 年第三季奧氮平產品組合權利的出售和更高的製造成本所抵消。

Gross margin as a percentage of revenue increased to 82.2%.

Gross margin primarily benefited from favorable product mix and higher realized prices, partially offset by the sale of rights for the olanzapine portfolio in Q3 2023 and higher manufacturing costs.

R&D expenses increased 13%, driven by continued investment in both our early and late-stage portfolio.

由於對早期和後期投資組合的持續投資，研發費用增加了 13%。我們確認了 28 億美元的收購智慧財產權與研發費用，主要與收購 Morphic Therapeutics 有關。

We recognized $2.8 billion of acquired IPR&D charges primarily related to the acquisition of Morphic Therapeutics.

Marketing, selling, and administrative expenses increased 16%, primarily driven by promotional efforts supporting ongoing and future launches.

行銷、銷售和管理費用成長了 16%，這主要是受支援當前和未來發布的促銷活動的推動。由於新產品收入增加，營業收入增加至近 18 億美元，但部分被營業費用成長所抵銷。

Operating income increased to nearly $1.8 billion, driven by higher revenue from new products, partially offset by operating expenses growth.

The effective tax rate was 37.6%, reflecting the unfavorable impact of nondeductible acquired IPR&D charges.

實際稅率為37.6%，反映了不可抵扣的智慧財產權收購費用的不利影響。除收購的智慧財產權和研發的影響外，基本稅率與先前提供的指導一致。我們的每股盈餘為 1.19 美元，高於 2023 年第三季的 0.10 美元。

Other than the impact of acquired IPR&D, the underlying tax rate was consistent with previously provided guidance.

We delivered earnings per share of $1.18, up from $0.10 in Q3 2023.

And this includes a negative impact of $3.08 from acquired IPR&D charges.

On Slide 9, we quantify the effect of price, rate, and volume on revenue growth.

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。在 Zepbound 和 Mounjaro 的推動下，美國營收成長 46%，銷量成長 35%，但被 Trulicity 的下降部分抵消。美國的實際價格成長了 11%，這主要是由 Trulicity、Humalog 和 Verzenio 推動的。

US revenue increased 46% with volume growing 35%, driven by Zepbound and Mounjaro, partially offset by declines in Trulicity.

Realized prices increased 11% in the US, primarily driven by Trulicity, Humalog, and Verzenio.

While Mounjaro and Zepbound demand remains strong and growing, quarter-by-quarter revenue growth in 2024 has been impacted by supply and channel dynamics.

儘管 Mounjaro 和 Zepbound 需求依然強勁且不斷成長，但 2024 年逐季營收成長受到供應和通路動態的影響。正如我們在第二季度所強調的那樣，供應增加導致出貨量增加，使我們能夠履行大多數批發商的延期交貨訂單，從而成為銷售的推動力。

As we highlighted in Q2, increasing supply led to higher shipments that allow us to fulfill the majority of wholesalers' back orders, serving as a tailwind to sales.

In Q3, we saw channel inventory decrease as wholesalers continue to navigate the complexities of high-volume cold chain products across a dozen different dose and brand combinations.

在第三季度，我們看到通路庫存減少，因為批發商繼續應對十幾種不同劑量和品牌組合的大批量冷鏈產品的複雜性。我們估計，庫存減少對 Mounjaro 和 Zepbound 第三季銷售額的影響佔這些產品總使用銷售額的百分比為中位數。

We estimate this inventory decrease impacted Q3 sales of Mounjaro and Zepbound by mid-single digits as a percentage of aggregate US sales of these products.

Europe revenue grew 39% in constant currency when excluding the impact of the divestiture of the olanzapine portfolio.

如果排除奧氮平投資組合剝離的影響，以固定匯率計算，歐洲收入成長了 39%。這一成長主要是由 Mounjaro、Verzenio 和 Jardiance 推動的。

This growth was primarily driven by Mounjaro, Verzenio and Jardiance.

We continue to be pleased with the Mounjaro Kwikpen launches in Europe and have now launched in the UK, Germany, Spain, and most recently, Italy.

我們仍然對 Mounjaro 快寫筆在歐洲的推出感到滿意，目前已在英國、德國、西班牙以及最近在義大利推出。受 Mounjaro 銷售成長以及 Verzenio 和 Jardiance 強勁表現的推動，以固定匯率計算，世界其他地區的收入成長了 45%。

Revenue in the rest of the world grew 45% in constant currency, driven by volume growth of Mounjaro and, to a lesser extent, strong performance of Verzenio and Jardiance.

Moving to China.

搬到中國。以固定匯率計算，營收成長了 17%。這一增長是由 Tauvid 銷售成長和 Humalog 有利的定價影響所推動的。最後，以固定匯率計算，日本的營收成長了 17%。 Mounjaro、Verzenio 和 Jardiance 的銷售成長推動了 20% 的銷售成長。

Revenue increased 17% in constant currency.

This increase was driven by volume growth of Tyvyt and favorable pricing impacts for Humalog.

Finally, Japan grew 17% in revenue in constant currency.

Volume growth of 20% was driven by uptick of Mounjaro, Verzenio, and Jardiance.

Slide 10 provides additional perspective of performance across our product categories.

投影片 10 提供了我們產品類別績效的更多觀點。 Mounjaro 的全球銷售額為 31 億美元，其中美國的淨銷售額近 24 億美元。我們繼續看到 Mounjaro 在美國以外的強勁成長，第三季銷售額總計 7.28 億美元。在早期乳癌適應症的強勁執行力推動下，Verzenio 繼續保持成長軌跡，全球銷售額成長 32%。

Mounjaro sales were $3.1 billion globally with almost $2.4 billion of net sales in the US.

We continue to see solid uptake of Mounjaro outside the US with sales in Q3 totaling $728 million.

Verzenio continues its growth trajectory with worldwide sales increasing 32%, driven by strong execution in the early breast cancer indication.

Jaypirca worldwide revenue was $81 million.

Jaypirca 全球收入為 8,100 萬美元。當排除第二季度確認的日本合作里程碑的影響時，Jaypirca 繼續保持其環比增長趨勢，表明 MCL 和 CLL 患者群體的持續吸收。

When excluding the impact of Japan collaboration milestones recognized in Q2, Jaypirca continued its sequential quarter-over-quarter growth trend, demonstrating sustained uptake in both the MCL and CLL patient population.

Worldwide Omvoh revenue increased to $41 million.

[整體]船上收入增加至 4,100 萬美元。我們對 [Ombo] 在美國獲得商業准入的進展感到高興。截至 2025 年 1 月，我們將在 3 個主要 PBM 中的 2 個獲得一線存取權限。我們也很高興在第三季獲得美國批准 Kisunla 和 Ebglyss。 Kisunla 的發布正在進行中，Ebglyss 的發布已於本月初開始。

We are pleased with our progress gaining commercial access for Omvoh in the US.

As of January 2025, we will have first-line access at 2 out of the 3 major PBMs.

We were also excited to receive US approval for Kisunla and Ebglyss in Q3.

The Kisunla launch is underway and progressing, and the Ebglyss launch began early this month.

We are pleased to have already secured formulary access for Ebglyss with one of the major PBMs.

我們很高興已經透過主要 PBM 之一獲得了 Ebglyss 的處方准入。由於銷量減少，Trulicity 全球收入下降了 22%，但實際價格上漲部分抵消了影響。

Worldwide Trulicity revenue declined 22%, driven by lower volume, partially offset by higher realized prices.

Slide 11 provides an update on the US launch of Zepbound.

幻燈片 11 提供了 Zepbound 在美國推出的最新情況。我們繼續看到強勁的成長趨勢，導致銷售額超過 12 億美元。我們對 Zepbound 有廣泛的處方覆蓋。截至 10 月 1 日，Zepbound 在商業領域擁有約 87% 的存取權限，我們正在不斷擴大我們的雇主選擇加入。

We continue to see strong growth trends leading to sales of over $1.2 billion.

We have broad formulary coverage for Zepbound.

As October 1, Zepbound has approximately 87% access in the commercial segment, and we are making ongoing progress expanding our employer opt-ins.

We are in the early days of launching single-dose Zepbound vials in the US exclusively through LillyDirect. 2.5- and 5-milligram single-dose vials are currently available to self-pay patients at a 50% or greater discount compared to the list price of other incretin medicines for obesity.

我們正處於透過 LillyDirect 在美國獨家推出單劑量 Zepbound 小瓶的初期階段。與其他治療肥胖症的腸促胰島素藥物的標價相比，2.5 毫克和 5 毫克單劑量小瓶目前可供自費患者購買，價格可享 50% 或更高的折扣。這項服務可以幫助更多患有肥胖症的成年人獲得 Zepbound，包括醫療保險受益人和沒有醫療保險受益人的人[M]。 （技術難度）

This offering helps even more adults living with obesity access Zepbound, including Medicare beneficiaries and those without

[employer coverage] (added by company after the call).

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

[幻燈片]12，我們提供了資本配置的最新情況。在投影片 13 上，您可以看到我們更新的全年指引。我們將營收指引更新為 454 億美元至 460 億美元。新的中點範圍代表 2024 年第四季與去年同期相比成長約 50%，顯示營收成長持續加速。

On Slide 13, you can see our updated guidance for the full year.

We are updating our revenue guidance range to $45.4 billion to $46 billion.

The new midpoint range represents approximately 50% growth in Q4 2024 compared to the same quarter last year, demonstrating a continuation of revenue growth acceleration.

We are investing heavily in increasing supply of Tirzepatide and have been carefully balancing our demand creation activities and launches into new markets with our production to support continuity of care for patients.

我們正在大力投資增加替澤帕肽的供應，並一直在謹慎平衡我們的需求創造活動，並透過我們的生產進入新市場，以支持患者的連續性照護。

In Q3, we continued to be prudent scaling up and demand generation activities.

在第三季度，我們繼續謹慎擴大規模和創造需求活動。這是降低範圍上限的驅動器。我們仍然預計，與 2023 年下半年相比，我們將在 2024 年下半年實現腸促胰島素可銷售劑量產量增加至少 50% 的目標。

This is the driver for lowering the top end of the range.

We continue to expect that we will exceed our goals to increase production of incretin saleable doses by at least 50% in the second half of 2024 compared to the second half of 2023.

Now with all the doses of Mounjaro and Zepbound available, we will accelerate demand activities, and while there is a lag to flow-through revenue, we expect to see the impact of these efforts in [Q4] (corrected by company after the call) and into 2025.

現在，隨著所有劑量的 Mounjaro 和 Zepbound 的上市，我們將加速需求活動，雖然收入流動存在滯後，但我們預計將在第二季和 2025 年看到這些努力的影響。 Mounjaro 在國際上推出，為第四季的成長做出貢獻。

Lastly, we also expect new Mounjaro launches internationally to contribute to growing in Q4.

Our expected ratio of gross margin less OpEx divided by revenue remains unchanged on both a reported and a non-GAAP basis.

我們的預期毛利率減去營運支出除以收入的比率在報告和非公認會計原則的基礎上都保持不變。根據報告，其他收入和支出目前預計在 4.25 億美元至 3.25 億美元之間，按非公認會計準則計算保持不變。

Other income and expense is now expected to be in the range of $425 million to $325 million of expense on a reported basis and is unchanged on a non-GAAP basis.

We have updated our estimated effective tax rate to be approximately 17%, driven by the impact of non-deductible IPR&D in Q3.

受第三季不可抵扣智慧財產權和發展的影響，我們將估計的有效稅率更新為約 17%。目前預計每股收益（以報告計算）為 12.05 美元至 12.55 美元，以非 GAAP 計算為 13.02 美元至 13.52 美元。這兩個範圍都反映了前面提到的更新以及截至第三季約 31 億美元的智慧財產權和研發費用。現在我將把電話轉給 Dan，強調我們在研發方面的進展。

EPS is now expected to be in the range of $12.05 to $12.55 on a reported basis and $13.02 to $13.52 on a non-GAAP basis.

Both ranges reflect the updates mentioned earlier as well as acquired IPR&D charges through Q3 of approximately $3.1 billion.

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

Thanks, Lucas.

謝謝，盧卡斯。禮來研發部又迎來了一個有成效的季度。讓我先分享一些後期更新，包括我們在最近的醫學大會上分享的一些令人興奮的第三階段數據。從神經科學開始。昨天，在阿茲海默症會議的臨床試驗上，我們很高興分享III 期TRAILBLAZER-ALZ 6 試驗的積極結果，該試驗評估了多納單抗治療開始時的不同劑量方案，以了解其對ARIA-E 的影響。在本次試驗中，我們測試了改良的滴定法，將 1 瓶多南單抗從第一次輸注改為第三次輸注，如投影片 14 所示。

Lilly R&D had another productive quarter.

Let me begin by sharing some late phase updates, including some exciting Phase III data that we shared at recent medical congresses.

Starting with neuroscience.

Yesterday, at the clinical trials in Alzheimer's Disease Conference, we were pleased to share positive results from our Phase III TRAILBLAZER-ALZ 6 trial, which evaluate different dosing regimens for initiation of donanemab treatment to understand their effect on ARIA-E.

In this trial, we tested a modified titration, which shifted 1 vial of donanemab from the first infusion to the third, as shown on Slide 14.

We designed this modified titration to achieve identical total dose of donanemab administered in the first 3 months as does our standard dosing regimen, but we hypothesized that the smoother increase in dose could result in less ARIA.

我們設計了這種改進的滴定法，以實現前 3 個月內給予的多納單抗總劑量與我們的標準給藥方案相同，但我們假設劑量的平穩增加可能會導致 ARIA 減少。

We were pleased to see in this trial that indeed by pharmacokinetic analysis, we achieved equivalent cumulative exposure between the modified titration and the standard dosing regimen.

我們很高興地看到，在這項試驗中，透過藥物動力學分析，我們確實在改良滴定法和標準給藥方案之間實現了等效的累積暴露量。結果，我們實現了相似水平的澱粉樣蛋白斑去除和磷酸 tau217 減少。

And as a result, we achieved similar levels of amyloid plaque removal and phospho-tau217 reduction.

Importantly, we also confirmed our hypothesis on ARIA and showed that the modified titration reduced the incidence of ARIA-E to 14% compared to 24% for those receiving the standard dosing regimen.

重要的是，我們也證實了我們對 ARIA 的假設，並表明改良滴定法將 ARIA-E 的發生率降低至 14%，而接受標準給藥方案的患者的 ARIA-E 發生率為 24%。此外，與標準給藥方案相比，使用改良滴定法觀察到有症狀ARIA-E 的頻率較低、所有類別ARIA-E 的放射照相嚴重程度較低以及ApoE4 基因型攜帶者中ARIA-E 較低。我們計劃在未來幾週內向 FDA 提交關於此修改滴定的補充 BLA。

As well, lower frequency of symptomatic ARIA-E, lower radiographic severity of all categories of ARIA-E and lower ARIA-E in APOE4 genotype carriers was observed using the modified titration as compared to the standard dosing regimen.

We plan to submit a supplemental BLA to the FDA in the coming weeks for this modified titration.

Our efforts on remternetug continue to progress, and we are starting a Phase III efficacy study of remternetug focused on preclinical stages of the disease, similar to our ongoing TRAILBLAZER-ALZ 3 trial for donanemab, where we are trying to reduce the risk of progression of symptomatic Alzheimer's disease.

我們在remternetug 方面的努力繼續取得進展，我們正在開始一項remternetug 的III 期療效研究，重點關注疾病的臨床前階段，類似於我們正在進行的Genetumab TRAILBLAZER-ALZ 3 試驗，我們正在努力降低疾病進展的風險有症狀的阿茲海默症。

In this upcoming Phase III registrational trial called TRAILRUNNER-3, we are evaluating a fixed duration of monthly subcutaneous administration of remternetug, offering what we see as a potentially convenient option for this earlier patient population.

在即將進行的名為 TRAILRUNNER 3 的 III 期註冊試驗中，我們正在評估每月皮下注射 remternetug 的固定持續時間，為早期患者群體提供我們認為可能方便的選擇。我們將於明天在 CTAD 上分享有關 TRAILRUNNER 3 研究設計的更多細節。

We'll share more details about the study design of TRAILRUNNER-3 tomorrow at CTAD.

Turning to cardiometabolic health.

轉向心臟代謝健康。上個月，我們分享了我們每週基礎胰島素（稱為胰島素 efsitora alfa）的剩餘 III 期研究的數據。提醒一下，efsitora II 期包括 5 項全球註冊研究，其中 4 項針對成人第 2 型糖尿病患者，1 項針對成人第 1 型糖尿病患者。我們很高興每項研究都達到了與甘精胰島素或德谷胰島素相比非劣質 A1c 降低的主要終點，這兩種藥物是日常基礎輸入中最常用的藥物。

Last month, we shared data from our remaining Phase III studies for our weekly basal insulin called insulin efsitora alfa.

As a reminder, efsitora Phase III consists of 5 global registration studies, 4 of which are in adults with type 2 diabetes and 1 is in adults with type 1 diabetes.

We are pleased that each study met its primary endpoint of non-inferior A1c reduction versus insulin glargine or insulin degludec, which are the most frequently used in daily basal inputs.

In the studies evaluating efsitora in people with type 2 diabetes, the results demonstrated that efsitora achieved meaningful A1c reduction with relatively low hypoglycemia rates.

在評估 efsitora 對 2 型糖尿病患者的研究中，結果顯示 efsitora 實現了有意義的 A1c 降低，且低血糖率相對較低。我們對 QWINT-1 的結果感到特別興奮，其中使用一次性自動注射器透過固定劑量施用 efsitora。

We were particularly excited with the results for QWINT-1, in which efsitora was administered via fixed doses using a single-use auto-injector.

In this 52-week study in people with type 2 diabetes, efsitora lowered participants' A1c by 1.31% compared to 1.27% for insulin glargine.

在這項針對 2 型糖尿病患者的為期 52 週的研究中，efsitora 使參與者的 A1c 降低了 1.31%，而甘精胰島素則降低了 1.27%。這種令人印象深刻的 A1c 降低是在低血糖發生率的情況下實現的。

This impressive A1c reduction was achieved with low hypoglycemia rates.

Actually, efsitora had approximately 40% lower rates of severe or clinically significant hypoglycemia than just daily insulin glargine.

These data highlight the power of an easier-to-use dose form of weekly insulin for people who are just initiating basal insulin therapy for the first time.

這些數據凸顯了對於首次開始基礎胰島素治療的人來說，更容易使用的劑量形式或每週一次胰島素的力量。我們期待與全球監管機構討論 QWINT 第三階段計劃的結果。

We look forward to discussing the results from the QWINT Phase III program with global regulatory agencies.

It has also been a productive quarter for our late-phase incretin programs.

對於我們的後期腸促胰島素計畫來說，這也是一個富有成效的季度。首先，如幻燈片15 所示，我們分享了SURMOUNT-1 III 期研究的積極數據，該研究對患有糖尿病前期和肥胖或超重的成年人進行了替西帕肽治療，該研究表明，患有2 型糖尿病的風險顯著降低了94%。

First, as shown on Slide 15, we shared positive 176-week data from the SURMOUNT-1 Phase III study of tirzepatide in adults with prediabetes and obesity or overweight, which demonstrated a remarkable 94% reduction in the risk of developing type 2 diabetes.

This is the longest-duration tirzepatide data to date, and we are highly encouraged to see that patients on the 15-milligram dose achieved a sustained weight loss of nearly 23% over more than a 3-year treatment period, and that this weight loss was accompanied by a significant reduction in risk of developing diabetes.

這是迄今為止持續時間最長的替澤帕肽數據，我們非常高興地看到服用 15 毫克劑量的患者在超過 3 年的治療期內實現了近 23% 的持續體重減輕，並且這種體重減輕伴隨著罹患糖尿病的風險顯著降低。我們期待在下週的肥胖週上分享詳細的結果。

We look forward to sharing the detailed results next week at Obesity Week.

These results add to compelling data showing the benefit of the combined pharmacology of dual GIP and GLP-1 receptor agonism in several obesity-related complications, including type 2 diabetes, metabolic dysfunction-associated steatohepatitis or MASH, moderate to severe obstructive sleep apnea, and heart failure.

These results add to compelling data showing the benefit of the combined pharmacology of dual GIP and GLP-1 receptor agonism in several of these related complications, including type 2 diabetes, metabolic dysfunction-associated steatohepatitis or MASH, moderate to severe obstructive sleep apnea, and心臟衰竭.

We are working quickly to bring tirzepatide to more adults living with obesity and its complications, and we are pleased to share that we expect US regulatory action for tirzepatide in adults with obesity and obstructive sleep apnea yet this year, and that we will submit for US approval of tirzepatide in adults with obesity and heart failure with preserved ejection fraction before the end of this year.

我們正在迅速努力，為更多患有肥胖症及其併發症的成年人提供替澤帕肽，我們很高興地告訴大家，我們預計今年美國將對患有肥胖症和阻塞性睡眠呼吸中止症的成年人採取替澤帕肽監管行動，我們將向美國提交該監管行動今年年底前批准替澤帕肽治療射血分數保留的肥胖和心臟衰竭成人患者。

Another avenue to advance patient care is the maintenance of body weight reductions.

推進患者照護的另一個途徑是維持體重減輕。我們正在進行 2 項 IIIb 期減重維持試驗。第一個是 SURMOUNT MAINTAIN，它將 5 毫克替澤帕肽或替澤帕肽最大耐受劑量與安慰劑進行比較。

We are conducting 2 Phase IIIb weight loss maintenance trials.

The first is SURMOUNT-MAINTAIN, which compares either tirzepatide 5 milligrams or tirzepatide maximum tolerated dose to placebo.

The second is ATTAIN-MAINTAIN, which evaluates our oral GLP-1, orforglipron, versus placebo after tirzepatide or semaglutide in participants who complete SURMOUNT-5, the IIIb head-to-head study of tirzepatide versus semaglutide.

第二個是ATTAIN MAINTAIN，它在完成SURMOUNT-5（替澤帕肽與索馬魯肽的IIIb 頭對頭研究）的參與者中評估我們的口服GLP-1、orforglipron 與安慰劑在替澤帕肽或索馬魯肽治療後的情況。我們期待在今年稍後分享 SURMOUNT-5 的頂線數據讀數。

We look forward to sharing the top line data readout for SURMOUNT-5 later this year.

Next, in oncology.

接下來，在腫瘤學方面。 III 期 EMBER-3 研究評估了我們的口服 SERD、imlunestrant 對二線 ER 陽性 HER2 陰性轉移性乳癌患者的療效，結果呈陽性。該研究評估了 3 個組別，Imlunestrant 作為單一療法，研究者選擇內分泌治療單一療法，以及 Imluunestrant 與 abemaciclib 聯合治療。根據該試驗的結果，我們預計將在年底前向 FDA 提交 NDA，並期待在即將召開的醫學會議上分享詳細結果。

The Phase III EMBER-3 study evaluating our oral SERD, imlunestrant in patients with second-line ER-positive HER2-negative metastatic breast cancer was positive.

The study evaluated 3 arms, imlunestrant as a monotherapy, investigator choice of endocrine therapy monotherapy, and imlunestrant in combination with abemaciclib.

Based on the results from this trial, we expect to submit an NDA to the FDA by year-end, and we look forward to sharing detailed results at an upcoming medical meeting.

The Phase III portion of the olomorasib first-line KRAS G12C lung cancer study is now underway, the first Phase III trial for this class of medicines in newly diagnosed, locally advanced or metastatic lung cancer, regardless of PDL1 expression.

olomoracib 一線 KRAS G12C 肺癌研究的 III 期部分正在進行中，這是該類藥物在新診斷的局部晚期或轉移性肺癌中的首個 III 期試驗，無論 PD-L1 表達如何。

This comes after recently defining the dose of the medicine in combination with standard of care regimens in consultation with the FDA under Project Optimus.

先前，在 Optimus 計畫下，最近與 FDA 協商，結合標準護理方案確定了該藥物的劑量。我們仍然相信我們可以在此類中擁有領先的代理，並期待後期計劃的執行。

We continue to believe we could have a leading agent in this class and look forward to execution of the late-stage program.

Finally, in immunology, we're excited by the recent US FDA approval of lebrikizumab as Ebglyss for adults and children 12 years and older with moderate to severe atopic dermatitis.

最後，在免疫學方面，我們對最近美國 FDA 批准 lebrikizumab 作為 Ebglyss 用於治療患有中度至重度異位性皮膚炎的成人和 12 歲及以上兒童感到興奮。 Ebglyss 提供了一種新的一線生物治療方法，針對濕疹發炎的主要原因，在治療的初始階段後透過方便的每月一次的維持劑量，提供顯著的早期皮膚清除和瘙癢緩解。

Ebglyss provides a new first-line biologic treatment that targets a main cause of eczema inflammation that offer significant early skin clearance and itch relief with convenient once-monthly maintenance dosing following the initial phase of treatment.

We recently shared compelling long-term data showing that lebrikizumab provides sustained disease control for up to 3 years in more than 80% of patients with moderate to severe atopic dermatitis, who responded to Ebglyss treatment at 16 weeks.

我們最近分享了令人信服的長期數據，顯示 lebrikizumab 可以為超過 80% 的中度至重度異位性皮膚炎患者提供長達 3 年的持續疾病控制，這些患者在 16 週時對 Ebglyss 治療有反應。

We have also initiated 2 Phase III studies of lebrikizumab in adults with perennial allergic rhinitis and chronic rhinositis with nasal polyps.

我們也啟動了兩項 lebrikizumab 針對患有常年性過敏性鼻炎和伴有鼻息肉的慢性鼻炎的成年人的 III 期研究。隨著我們不斷擴大免疫學產品組合以幫助更多患者，我們正在進行兩項III 期研究，評估ixekizumab 和替澤帕肽一起治療肥胖或超重的銀屑病關節炎或中重度斑塊狀銀屑病患者。肥胖與罹患自體免疫疾病的風險增加有關，並對疾病結果產生負面影響。

As we continue to expand our immunology portfolio to help more patients, we're conducting 2 Phase III studies evaluating ixekizumab and tirzepatide together in patients with obesity or overweight in either psoriatic arthritis or moderate to severe plaque psoriasis.

Obesity is associated with an increased risk of developing autoimmune diseases and can negatively impact disease outcomes.

Taltz has already demonstrated strong efficacy in treating psoriatic arthritis and plaque psoriasis.

Taltz 已證明在治療乾癬性關節炎和斑塊狀乾癬方面具有強大的功效。我們很高興看到與 Zepbound 提供的顯著且持續的減肥效果相結合，可以為患者帶來額外的好處。

And we are excited to see the potential for additional benefits for patients when combined with a significant and sustained weight loss offered by Zepbound.

Slide 16 shows select pipeline opportunities as of October 28 and Slide 17 shows potential key events for the year.

幻燈片 16 顯示了截至 10 月 28 日的精選管道機會，幻燈片 17 顯示了今年潛在的關鍵事件。我已經介紹了我們的後期進展，所以現在我將快速介紹早期階段管道的更新。

I've already covered our late-phase progress so now I'll quickly cover updates for the early phase pipeline.

Starting again with neuroscience.

再次從神經科學開始。我們最近啟動了一項表調節蛋白抗體治療與遠端感覺多發性神經病變相關的慢性神經病理性疼痛的 II 期研究。我們之前已經在管道的第一階段展示了這種分子作為一種未公開的疼痛機制。

We recently initiated a Phase II study of an epiregulin antibody in chronic neuropathic pain associated with distal sensory polyneuropathy.

We had previously shown this molecule in Phase I of the pipeline as an undisclosed mechanism in pain.

We also have begun Phase I studies on two new neurodegeneration assets, an alpha-synuclein-directed siRNA and a tau-directed siRNA.

我們也開始對兩種新的神經退化性疾病資產進行 I 期研究，即針對 α-突觸核蛋白的 siRNA 和針對 tau 的 siRNA。今天早些時候，我們在 CTAD 上披露了口服抗 tau 藥物 II 期研究的詳細結果。雖然兩者都不能減緩早期症狀性阿茲海默症的臨床衰退，但生物標記數據表明對 tau 病理體積和神經發炎有潛在影響。該研究的安全後續行動正在進行中。

Earlier this morning at CTAD, we disclosed detailed results from our Phase II study of our oral anti-tau agent.

While neither dose slowed clinical decline in early symptomatic Alzheimer's disease, biomarker data suggests potential impacts on tau pathology volume and neuro inflammation.

Safety follow-ups for the study are ongoing.

Turning to cardiometabolic health.

轉向心臟代謝健康。在接下來的幾天裡，我們將啟動[Alora] lenti 的II 期研究，這是我們的長效胰淀素受體激動劑，與替澤帕肽聯合治療2 型糖尿病患者，以及單獨或聯合使用bimagrumab 的II 期研究使用替澤帕肽進行慢性體重管理以及沒有第 2 型糖尿病的參與者。我們也將把我們的長效鬆弛素分子 [bolanrelaxant] 推進到成人慢性腎臟病患者的 II 期臨床。

In the coming days, we will initiate a Phase II study of eloralintide, our long-acting amylin receptor agonist for chronic weight management in combination with tirzepatide in patients with type 2 diabetes and the Phase II study of bimagrumab alone or in combination with tirzepatide for chronic weight management and participants without type 2 diabetes.

We will also be advancing volenrelaxin our long-acting relaxin molecule into Phase II in adults with chronic kidney disease.

We removed the Phase I APOC III siRNA asset in cardiovascular disease as it did not meet our bar for continuing clinical development.

我們刪除了心血管疾病領域的 I 期 APOC III siRNA 資產，因為它不符合我們持續臨床開發的標準。在腫瘤學領域，2024 年對於新的臨床研究來說仍然是豐收的一年。自從上次通話以來，我們將 3 個新分子推進到 I 期研究。我們的口服 SMARCA2 或 BRM 抑制劑、KRAS G12D 抑制劑和 PAN KRAS 抑制劑。

In oncology, 2024 continues to be a very productive year for new clinical starts.

Since the last call, we advanced 3 new molecules into Phase I studies.

Our oral SMARCA2 or BRM inhibitor, our KRAS G12D inhibitor, and our PAN KRAS inhibitor.

These 3 initiations bring to total new clinical starts in oncology in 2024 to 7, exceeding the goal we shared earlier this year to put at least 5 new potential medicines in the clinic.

這 3 項啟動使 2024 年腫瘤學新臨床啟動總數達到 7 個，超出了我們今年早些時候分享的將至少 5 種新的潛在藥物投入臨床的目標。我們已經透過 3 種不同的方式做到了這一點，這象徵著我們利用治療方式多樣化來對抗治療抗藥性和改善患者治療結果的策略。我們預計這些新的臨床計畫將為我們帶來令人興奮的 2025 年，因為我們希望了解哪些項目為患者提供差異化且重要的早期臨床數據集。

And we've done that across 3 different modalities, emblematic of our strategy to utilize therapeutic modality diversification to combat treatment resistance and improve patient outcomes.

We expect this new slate of clinical programs will set us up for an exciting 2025 as we look to see which programs deliver differentiated and important early clinical data sets for patients.

Finally, in early-stage immunology, we're also excited to initiate several new Phase II studies.

最後，在早期免疫學方面，我們也很高興啟動幾項新的 II 期研究。首先，我們將 Dice Therapeutics 收購的一種口服 IL-17 抑制劑 DC853 轉移到治療中度至重度斑塊型乾癬成人的 II 期臨床。我們在管道中移除了 DC806，轉而使用 853，這是一種更有效的分子。其次，我們正在啟動一項針對中度至重度活動性潰瘍性結腸炎成人患者聯合使用 altrecabart 和 mirikizumab 的 II 期研究。

First, we moved DC853, an oral IL-17 inhibitor from the Dice Therapeutics acquisition into Phase II in adults with moderate to severe plaque psoriasis.

And we removed DC806 from the pipeline in favor of 853, which is a more potent molecule.

Second, we are initiating a Phase II study combining eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis.

In addition, we are terminating the Phase IIb study of peresolimab in rheumatoid arthritis due to the overall benefit risk profile of the molecule in this study.

此外，由於本研究中該分子的整體獲益風險狀況，我們將終止 parasolimab 治療類風濕關節炎的 IIb 期研究。最後，在8 月歡迎我們的Morphic 同事加入禮來公司後，我們的產品線現在包括口服α-4-β-7 整聯蛋白抑制劑MORPH-057，該抑制劑處於II 期階段，用於治療中度至重度潰瘍性結腸炎和中度至重度克隆氏症。

Finally, after welcoming our Morphic colleagues to Lilly in August, our pipeline now reflects the oral alpha-4-beta-7 integrin inhibitor, MORPH-057 in Phase II for moderate to severe ulcerative colitis and moderate to severe Crohn's disease.

Q3 was an exceptionally productive quarter for Lilly R&D, and we're pleased with our important progress we're making for patients across all of our therapeutic areas.

第三季度對於禮來研發來說是一個非常有成效的季度，我們對我們在所有治療領域為患者取得的重要進展感到高興。現在我將把電話轉回給戴夫，讓他作結束語。

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

Okay, thanks, Dan.

好的，謝謝，丹。在回答問題之前，讓我先簡單總結一下我們本季的進展。我們的 Mounjaro 和 Zepbound 以及腫瘤學、免疫學和神經科學藥物的收入成長強勁。我們的研發管線取得了重大進展，包括在美國批准用於治療中度至重度異位性皮膚炎的Ebglyss、在日本和英國批准用於治療早期症狀性阿茲海默症的Kisunla，以及替澤帕肽和多納奈單抗的III 期研究的積極數據披露。

Before taking questions, let me briefly summarize our progress in the quarter.

We had strong revenue growth across both Mounjaro and Zepbound as well as our oncology, immunology, and neuroscience medicines.

Significant advancements in our pipeline included approval of Ebglyss for moderate to severe atopic dermatitis in the US, Kisunla for early symptomatic Alzheimer's disease in Japan and Great Britain, and positive data disclosures for Phase III studies of tirzepatide and donanemab.

We are confident in Lilly's bright future.

我們對禮來的光明未來充滿信心。我們現在已經在主要地區推出了一系列藥物，我們預計這些藥物將成為我們在這十年餘下時間成長的動力。它們是 Mounjaro、Jaypirca、Zepbound、Kisunla 和 Ebglyss。

We have now launched in major geographies the cohort of medicines that we expect will serve as the driver of our growth through the balance of this decade.

That is Mounjaro, Jaypirca, Zepbound, Kisunla, and Ebglyss.

We expect these products, together with our already launched products will contribute to strong growth of the company in 2025.

我們預計這些產品以及我們已經推出的產品將在 2025 年為公司的強勁成長做出貢獻。明年幫助更多患者。現在我將把電話轉給喬主持問答環節。

In addition, we plan to continue to scale R&D and step up our investment across manufacturing and commercial to support the successful launches of these medicines to help even more patients next year.

So now I'll turn the call over to Joe to moderate a Q&A session.

Thanks, Dave.

謝謝，戴夫。我們希望回答盡可能多的來電者的問題，以便及時結束我們的通話。 （活動說明）保羅，請提供問答環節的說明，然後我們就準備好迎接第一個來電者。

We'd like to take questions from as many callers as possible to conclude our call and timely manner.

(Event Instructions) So Paul, please provide the instructions for the Q&A session, and then we're ready for the first caller.

(Operator Instructions)

（操作員說明）

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Just to kick off the questions.

只是為了開始提問。您能否幫助我們將剛剛看到的第三季銷售報告與第四季隱含結果連結起來？這顯然是銷售量的大幅提升。聽起來，鑑於產能的提高，您現在正在加速需求生成工作。但我只是希望能更詳細地了解這些努力到底是什麼，以及您期望這些計劃能夠以多快的速度轉化為處方的加速。

Can you just help bridge a bit from the 3Q sales we just saw reported to the 4Q implied results?

It's obviously a substantial step-up in sales.

It sounds like part of this is you're now accelerating demand generation efforts, given the improved capacity.

But I was just hoping to get a little bit more color on exactly what those efforts are and how quickly you expect those programs can translate to an acceleration in prescriptions.

Thanks, Chris, for the question.

謝謝克里斯提出這個問題。我可能會交給帕特里克，因為我猜很多問題都與替澤帕肽相關，但讓盧卡斯根據需要介入。派崔克？

I'll maybe hand over to Patrik since I'm guessing a lot of the question is around tirzepatide-related but let Lucas jump in as needed.

Patrik?

Thank you very much, Chris.

非常感謝你，克里斯。我認為首先要強調的是，Mounjaro 和 Zepbound 的整體表現都非常強大。我們看到第三季略有加速成長，超過 25%，而且 2 型和肥胖症的基礎市場也持續成長。

I think it's first important to emphasize that the overall performance for both Mounjaro and Zepbound are very strong.

And we saw a slightly accelerated growth in Q3 of more than 25% and also the market, the underlying market for both type 2 and obesity continues to grow.

We took a more prudent approach than we anticipated in Q3, pretty much driven by the need to deliver a good consumer experience.

我們在第三季採取了比預期更加謹慎的方法，這很大程度上是出於提供良好消費者體驗的需要。根據我們今年上半年的經驗，這是我們進行任何投資的觸發因素之一，當時我們的客戶服務中心接到的許多電話都是關於供應的，實際上超過 20%。

That has been one of our triggers for any investment based upon the experience we faced in the first half of the year when a lot of the calls to our customer service center was about supply, actually more than 20%.

We are now down to less than 1% of those being supply-related.

現在，與供應相關的比例已降至不到 1%。因此，我們現在正在做的是，我們正在大力投資 DTC 工作，這是我們過去沒有做過的，供應使我們能夠在那裡進行大力投資。但這不是需求問題。

So what we are doing right now is that we are investing heavily in our DTC effort, which we haven't done in the past, supply allows us to invest strongly there.

But it's not a demand issue.

And similarly, we're fully leaning in on all the HCP promotional efforts, also providing samples in the marketplace to providers.

同樣，我們完全依靠 HCP 的所有促銷工作，也向供應商提供市場上的樣品。因此，基於當今市場的基本趨勢以及 Zepbound 和 Mounjaro 在 TRx、NBRx 和 TRx 方面的成長，我們仍然非常有信心，我們將在第四季度取得良好的表現。

So we remain very confident based upon the underlying trend in the marketplace today and also the growth of both Zepbound and Mounjaro in terms of TRx, NBRx and TRx that we are up for a good Q4.

Maybe just to add to that.

也許只是為了補充這一點。謝謝克里斯提出這個問題。當你看我提到的中點時，我們預計第四季度將增長 50%，與 42% 相比，增長了 8%。當你除去我們在第二季度提到的通路動態時，整個季度的成長速度非常一致，因此帕特里克提到的加速和驅動因素。也許只是補充一下，OUS 也是如此，我們將繼續推進並吸引新的國家/地區，我們也將推出 Mounjaro，這將推動第四季度的部分成長加速。

Thank you, Chris, for the question.

When you look at the midpoint that I mentioned, 50% growth that we expect for the fourth quarter compared with the 42% is a step-up of 8%.

When you remove the channel dynamics that we alluded in Q2, the step-up of growth is very consistent throughout the quarters, so the acceleration and the drivers are the ones that Patrik mentioned.

Maybe just to add to that, OUS as well, we continue to advance and get new countries that we are going to be launching Mounjaro as well that will drive that part of that growth acceleration in the fourth quarter.

Geoff Meacham, Citigroup.

傑夫‧米查姆，花旗集團。

I guess related to that, I just want to dig into the 3Q volatility.

我想與此相關，我只是想深入研究第三季的波動性。我的意思是，戴夫，您按順序提到了腳本需求。我想，有鑑於此，為什麼本季會出現如此大的縮編？我猜投資者正在試圖弄清楚連續趨勢是否可能是適度需求的領先指標，或者只是准入方面的推出的不穩定？

I mean, Dave, you mentioned the script demand sequentially.

I guess, so given that, why would you see such a big drawdown this quarter?

I guess investors are trying to figure out if the sequential trends are perhaps a leading indicator of a moderation demand or if it's just the lumpiness of the rollout in access?

Dave, you want to field that?

戴夫，你想派出那個嗎？

Yes.

是的。也許為了向我們提供您所問的宏觀問題，我認為首先，通路庫存存在著許多障礙。我認為參加本次電話會議的所有賣方分析師可能都像我們一樣為此苦苦掙扎。離開第一季度，我們可以回想起我們的許多劑型延期交貨，我們的批發商供應幾乎達到了最低點。第二季進行了補充庫存，然後第三季出現了縮減。

Maybe to give us kind of a macro thing you're asking there, I think first of all, there is a lot of lumpiness in channel stocking.

I think all the sell-side analysts on this call have probably struggled with that as we have.

Exiting Q1, we can recall that we had a number of our dosage forms on back order, and we pretty much reached a nadir of supply in the wholesalers.

That was restocked in Q2 and then we saw a drawdown in Q3.

I think what we really don't control and don't attempt to but as a reality is that downstream customers from Lilly wholesalers and retailers are making their own decisions about which of the 12 different dosage forms they want to stock and at what level.

我認為我們確實無法控制也不會嘗試控制，但事實上，禮來公司批發商和零售商的下游客戶正在自行決定他們想要以何種水平庫存 12 種不同劑型中的哪一種。這存在一些物理限制，冷鏈能力受到限制。他們正在設法解決財務和營運資金方面的限制。這些都是他們維持客戶服務水準的決定。

There are some physical constraints to that, cold chain capacity is constrained.

And there are financial constraints, working capital that they're managing to.

Those are their decisions to maintain their customer service levels.

I think what we've done is sort of move our set point of how much stock we want to have on hand before we go initiating demand-stimulating activities, which we had more or less caused from in the first half and never started for Zepbound.

我認為我們所做的就是在開始刺激需求的活動之前改變我們希望手頭上有多少庫存的設定點，這或多或少是由上半年引起的，但從未為 Zepbound 開始。請記住，我們在去年 12 月推出。

Remember, we launched in December of last year.

So I think in-market data, you guys can all read and you see, Geoff yourself, and we do see acceleration of both brands in Q3 over Q2 in actual consumption.

因此，我認為，你們都可以閱讀市場數據，傑夫本人也可以看到，我們確實看到兩個品牌在第三季度的實際消費量比第二季度有所增長。我們的估計是，隨著美國對這一需求的刺激，這種需求將會持續或加速，正如帕特里克所說，我們將在 11 月中旬開始認真地這樣做。

And our estimate is that will continue or accelerate as we add US stimulation to that demand, which, as Patrik said, we're going to begin doing here really mid-November in earnest.

Ex-US demand is another factor that affects sales and that, too, we moved out launches by about a quarter just to make sure we had enough buffer.

美國以外的需求是影響銷售的另一個因素，我們也將發佈時間推遲了大約四分之一，只是為了確保我們有足夠的緩衝。因此，當顧客需要處方時，他們可以可靠地配藥。我認為這對我們保持這種信任非常重要。

So when customers want a prescription, they could get it filled reliably.

And I think that's an important thing for us to keep that trust going forward.

So at a macro level, is there a demand problem here?

那麼從宏觀層面來說，這裡是否存在需求問題呢？不，實際上。供應有問題嗎？不會。因此，當我們在第四季度增加供應時，我們會仔細地將這兩件事結合在一起，正如我所提到的，我們將超過 50% 的成長數字。

No, actually.

Is there a supply problem?

No.

Although if we had unlimited demand, there would be.

So we're carefully gating those two things together as we escalate supply in Q4, which, as I mentioned, we're going to beat the 50% growth number.

You'll see us grow our demand stimulation as well.

您也會看到我們也增加了需求刺激。我認為這確實與第四季度有關，但更與 2025 年第一季有關，並持續加速。所以生意超健康。我們對自己所處的位置感覺良好。顯然，本季度出現了一些波動，但我認為這裡的潛在成長正如我們所希望的那樣強勁。

And I think that's really about Q4 but even more about Q1 of 2025 and continuing acceleration there.

So business is super healthy.

We feel good about where we are.

Obviously, there was some choppiness this quarter, but I think underlying growth here is as strong as we would have hoped.

Evan Seigerman, BMO Capital.

埃文·塞格曼，BMO 資本。

Joe, congrats on your new job.

喬，恭喜你找到新工作。我想談談複利。鑑於頭條新聞，您認為複合藥物正在影響需求嗎？其次，您如何看待 FDA 在短缺清單上與複合相關的胡言亂語？這似乎是一個熱門問題，所以我很想聽聽你的觀點。

I want to touch on compounding.

Given the headlines, do you believe that compounded drugs are impacting demand?

And secondarily, how do you frame kind of the FDA's waffling on the shortage list as it relates to compounding?

It seems that this has been a hot issue so I'd love your perspective.

Thanks, Evan.

謝謝，埃文。是的，確實是熱門話題。也許在談論我們看到的是否有財務影響方面，我會讓帕特里克回答這個問題，然後也許是圍繞 FDA 的更廣泛的問題，我會讓戴夫插話。

Yes, hot topic indeed.

Maybe in terms of talking about whether there's a financial impact that we see that, I'll let Patrik field that, and then maybe the broader question around the FDA, I'll let Dave chime in.

So Patrik?

So thank you very much, Evan.

非常感謝你，埃文。我認為眾所周知，在量化複利市場方面沒有一個可靠的來源。知道這主要是現金，這可能是相信其中一些患者處於適應症外的原因。因此，從我們的角度來看，我們實際上並沒有估計複利會對我們的業務產生巨大的財務影響。

I think as we all know, there is not one reliable source when it comes to quantifying the compounding market.

We know that it's mainly cash and are probably reasons to believe that some of those patients are off-label.

So from our perspective, we actually don't estimate there to be a huge financial impact of compounding on our business.

And our major concern here has been driven by safety with thousands of people in the US getting medicine that is not approved by the FDA for quality, safety or efficacy purposes.

我們在這裡主要擔心的是安全性，數以千計的美國人正在購買未經 FDA 出於品質、安全或功效目的而批准的藥物。因此，這一直是我們所關心的問題，正如我們之前所說，我們現在主要致力於推動美國市場對肥胖和 2 型糖尿病患者的需求。

So that has been our concern, and we are mainly leaning in now, as we said earlier, to drive demand in the US marketplace for patients with obesity and type 2 diabetes.

Yes.

是的。我的意思是，我真的無法過多推測 FDA 的想法。但我認為其他評論員已經提到，這種情況持續的時間越長，他們自己的監管框架面臨的風險就越大。所以我的猜測是，FDA 對此感到擔憂，他們希望贏得這場官司，並且他們正在全力以赴地做到這一點。我想，還有另一種觀點認為他們不在乎，但我認為他們確實在乎。

I mean, I can't really speculate too much what's going through the FDA's mind.

But I think other commentators have mentioned that the longer this goes on, the more risk they have to their own regulatory framework.

And so my guess is the FDA is concerned about that and they want to win this case, and they're putting their ducks in a row to do so.

There is an alternate, I guess, perspective that they don't care, but I think they do care.

The other thing I'll say is we work closely with the FDA to approve new capacities.

我要說的另一件事是我們與 FDA 密切合作批准新產能。這裡需要注意的是，我們可以對此做更多的事情，並且我們直接與他們溝通。他們在這裡沒有聽到任何他們沒有收到你的消息。但我們在註射劑填充能力和原料藥產能方面進行了大量投資。交付時間表的一個重要部分實際上是監管流程本身，這可能需要 2 到 4 年的時間。

And it's important to note here, we could do more with that and we communicate this to them directly.

They're not hearing anything here they haven't heard from me already.

But we have invested massively in parenteral filling capacity and API capacity.

And a big part of the delivery schedule for that, which can take 2.5 to 4 years is actually the regulatory process itself.

So it's difficult to think about a world where the workaround to that is to unleash unregulated product.

因此，很難想像一個解決辦法是釋放一個不受監管的產品的世界。解決方法應該是與公司合作，加快合法產品的交付，我們將充分接受這一討論。我們現在有很多事情正在與 FDA 排隊，或者即將進行，這可能會加快已經令人印象深刻的產量成長。我們歡迎這個機會。

The workaround should be to collaborate with the companies to speed up legitimate product delivery, and we would embrace that discussion fully.

We have a lot of things in queue now with the FDA or about to be that could speed up what already is an impressive production ramp.

We would welcome that opportunity.

Seamus Fernandez, Guggenheim.

謝默斯·費爾南德斯，古根漢。

My question is actually on how you feel the compounding situation could be resolved by the availability of an oral small molecule that can be provided at substantial scale.

我的問題實際上是關於您認為如何透過可大規模提供的口服小分子來解決複合情況。這似乎是應對日益複雜的危機的最簡單、最直接的答案。

It seems like this is the easiest and most straightforward answer to the compounding crisis.

Once that occurs, does it make sense with that availability regardless of products, that the agency would move to resolve the crisis?

一旦發生這種情況，無論產品如何，該機構都會採取行動解決危機，這是否有意義？或者這是一個逐個產品的情況，如果 Novo 在這種情況下無法讓他們的房子井然有序，我們最終會隨著時間的推移而讓這個複雜的問題消失？

Or is this a product-by-product situation such that if Novo can't get their house in order in that context, that we'll end up with having this compounding issue just draw out over time?

Thanks, Seamus.

謝謝，西莫。是的，我會把情況交還給戴夫。我的意思是，如果你指的是我們的——當然，我們的口服GLP1 非肽激動劑，或者forglipron，我的意思是，距離III 期臨床試驗並最終進入市場還有很長的路要走。但是戴夫，也許你會在之前的評論中添加什麼？

Yes, I'll hand back to Dave.

I mean, if you're referring to our -- of course, our oral GLP1 non-peptide agonist, orforglipron, I mean, that's still a ways away from the Phase III turning over and then ultimately coming to market.

But Dave, maybe what would you add to your prior comments?

Yes.

是的。嗯，我的意思是，從長遠來看，當然，地球上有 10 億潛在客戶。我想我們已經說過，我已經說過，可能其中很大一部分得到良好服務的唯一方法是口服產品，因為與腸胃外填充蛋白質相比，口服產品的生產系統效率更高。所以這很重要。當然，我們在這方面處於領先地位，我們希望看到 orforglipron 取得成功，我們需要數據，提交和發布將在不到兩年的時間內完成。

Well, I mean, in the long run, of course, there's a potential billion customers on the planet.

And I think we've said, I've said that probably the only way that a big chunk of those are served well is with the oral products because of the production system efficiencies there versus parenteral filling of proteins.

So it's important.

Of course, we're in the lead there and we want to see orforglipron be successful but we need the data and the submission and launch would put that sometime something like less than two years from now.

But first of all, I wouldn't characterize compounding as a crisis.

但首先，我不會將複利描述為一場危機。對我們來說當然不是 1。我認為問題是人們受到傷害和欺騙，對嗎？所以這就是我們希望看到的停止。但正如派崔克所說，我們並沒有真正看到複利對禮來公司的財務影響。

It certainly isn't one for us.

I think the problem is people are being harmed and duped, right?

And so that's kind of what we like to see stop.

But as Patrik said, we don't really see a financial impact on Lilly of compounding.

I think as an industry, we should probably be worried that if this grows and is allowed to continue, then it sort of creates us back to our generic world.

我認為作為一個行業，我們可能應該擔心，如果這種情況繼續發展並允許繼續下去，那麼它會讓我們回到我們的通用世界。但正如我所說，我認為 FDA 是出於充分的理由、出於公共安全的原因想要阻止這種情況，他們會這麼做的。

But as I said, I think the FDA wants to stop that for good reasons, for public safety reasons, and they'll do that.

At the end of the day, FDA views this as a product-by-product analysis.

最終，FDA 將其用作逐個產品的分析。目前，替西帕肽並不短缺，因此不應允許大規模復配。停留在法庭上等等，但我們認為這應該是那裡的狀態。因為它與您想問的索馬魯肽有關，所以不用問，儘管我們正在努力透過減少對索馬魯肽的需求和增加購買慾望來幫助解決他們的供應問題。所以也許會這樣解決。

And right now, tirzepatide is not in shortage and therefore, mass compounding should not be permitted.

As it relates to semaglutide you’ll have to ask, Novo about that, although we're working hard to help Novo with their supply problem by reducing demand for semaglutide and increasing it for tirzepatide.

So maybe it will resolve that way.

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Maybe if I can ask the demand question and supply question differently.

也許我可以用不同的方式提出需求問題和供給問題。因此，現在您將在今年下半年開始一些需求產生活動。您如何看待它的訪問方面？您認為到 2025 年，取得、需求產生和供應之間是否存在某種趨同？

So now you will be starting some demand generation activities in the latter part of the year.

How are you thinking about the access side of it?

Do you think that there is some convergence between access, demand generation and supply into 2025?

Because we are hearing that some of the payers are restricting it even more now.

因為我們聽說一些付款人現在限制得更多。因此，我很想了解您對接入方面的想法，因為您可能已經完成了談判。

So I would love to understand your thoughts on the access side, given that you have done the negotiations at this point.

Thanks, Mohit.

謝謝，莫希特。我將交給帕特里克（Patrik）討論可能的訪問更新並繼續。

I'll hand over to Patrik to talk about maybe access updates and go forward.

Maybe just a few comments on Mounjaro then moving into Zepbound.

也許只是對 Mounjaro 產品進入 Zepbound 的一些評論。我認為有了 Mounjaro，我們的訪問率非常好，達到了 93%。我認為我們幾乎已經達到了商業和醫療保險領域所需的水平。就 Zepbound 而言，我認為我們已經在創紀錄的時間內取得了進展，接近 90% 的商業訪問，我們將繼續看到雇主選擇加入方面的改進。

I think with Mounjaro, we have really good access and it's 93%.

And I think we are pretty much where we need to be across commercial and Medicare.

In terms of Zepbound, I think we've made progress in record time here, close to 90% commercial access, and we'll continue to see improvement in terms of employers opt-in.

You are correct, we hear stories about some employers opting out, but the major trend is actually in favor of opting in.

你是對的，我們聽說過一些雇主選擇退出的故事，但主要趨勢實際上是支持選擇加入以對抗藥物。我們絕對處於 50% 的北部。我認為我們將在 2026 年上半年獲得一些新數據，因為大多數員工所做的這些決定將在新的一年中 1/1 生效。

We are definitely north of the 50%.

And I think we will have some new data in the first part of 2026 since most of the employees are making those decisions effective 1/1 in the new year to come.

So I think we are very, very optimistic in that part of our business but also continuing to make progress in access for Medicaid.

因此，我認為我們對這部分業務非常非常樂觀，而且在醫療補助的取得方面也繼續取得進展。

And just since we connected last time, we have gained 6 incremental states for Medicaid, and most recently effective 10/1, we have California and Massachusetts.

自從我們上次連接以來，我們已經獲得了 6 個醫療補助州的增量，最近生效的 10/1，我們有加利福尼亞州和馬薩諸塞州。這麼大的國家現在覆蓋了超過 3000 萬人的生命，我們期望在這一領域繼續取得進展。最後，我只想強調有吸引力的睡眠呼吸中止症的潛在批准，[阻塞性]睡眠呼吸中止症的批准將幫助我們選擇加入雇主。

So big states are now covering more than 30 million lives, and we expect to continue to make progress in that space.

And lastly, I would just emphasize the potential approval here of obstructive sleep apnea, the approval of obstructive sleep apnea will help us with employer opt-in.

Of course, we know that outcome studies are critical to convince employers.

當然，我們知道結果研究對於說服雇主至關重要。但最重要的是，它也為獲得 Medicare 的准入機會打開了大門，隨著 CMS 在今年 4 月宣布的決定，我們有信心獲得 Medicare 的准入機會。因此，我認為我們有很多理由對 2025 年的前景感到興奮，這得益於美國商業領域准入的改善以及我們對 LillyDirect 所做的投資。

But on top of that, it also opens up the door for access in Medicare and with the decision that CMS announced back in April this year, we are confident that we will gain access out of OSA in Medicare.

So I think we have many reasons to be excited about the outlook for 2025, driven by improved access across the commercial America space as well as the investments we have done with LillyDirect.

Thanks, Patrik.

謝謝，派崔克。 Mohit，即使您沒有詢問 OUS 訪問權限，而且我也不允許提出多部分問題，也許我會看看 Ilya 是否願意插話並談談迄今為止 OUS 訪問進度以及我們對未來的看法。伊利亞（Ilya），你想－－你想插話一下嗎？

And Mohit, even though you didn't ask about OUS access and I don't allow multipart questions, maybe I'll see if Ilya wants to chime in and talk a little bit about OUS access progress to date and what we see going forward.

Ilya, would you like to chime in on that?

Sure.

當然。總體而言，我們在推出 OUS 方面取得了重大進展。我們都可以治療 2 型糖尿病，在英國、德國和日本等一些市場，我們看到我們在這些市場的份額取得了良好的進展，在這些市場中，我們已經在新患者中佔據領先的市場份額從那些地方開始。當然，我們需要繼續開拓其他市場的進入。

Overall, we have seen significant progress on our launches OUS.

We have both access for type 2 diabetes, we’re in some of the markets like UK, Germany, and Japan, and we're seeing some good progression of our share in those markets where we're already seeing leading share of market in new patient starts in those places.

Of course, we need to continue to develop access in other markets.

And then on the chronic weight management side, we feel good about the prospects of adding countries to drive access.

然後在慢性疼痛管理方面，我們對增加國家來推動准入的前景感到樂觀。同時，還有像英國、阿聯酋和沙烏地阿拉伯這樣發達的自付費市場，我們已經看到我們的份額和滲透率有了顯著的進步，實際上我們在這些市場中的TRx 市場份額處於領先地位。

At the same time, there's also developed self-pay markets like UK, UAE, and Saudi, where we're already seeing significant progression of our share and penetration where we actually have leading share of market in TRx in these markets.

And we continue to focus on both developing the self-pay but also increasing access for both type 2 diabetes and chronic weight management over time.

隨著時間的推移，我們將繼續專注於發展自付費用，同時增加第 2 型糖尿病和慢性疼痛管理的可及性。隨著我們進入新市場，這將是漸進的。

And that will be gradual as we enter new markets.

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

I was just wondering, I know you've already framed out kind of where supply would be for the second half of this year.

我只是想知道，我知道你們已經制定了今年下半年的供應情況。再次，當我們展望 2025 年時，您能否讓我們提前了解一下您的供應能力工作進展情況以及我們應該如何考慮新產能的數量，特別是在您可以帶來的自動注射器方面2025 年？

Again, as we look out to 2025, can you give us an early read on how your supply capacity efforts have been progressing and how we should think about the amount of new capacity, especially on the auto-injector side that you can bring on for 2025?

I can start, Lucas jump in.

我可以開始了，盧卡斯插話。 我的意思是，我們將有機會像今年二月初的指導電話會議那樣闡述這一點。但從質量上來說，你可以看到我們在該領域的投資和資本支出的流動，你可以回顧 3 年左右，並期望我們當時宣布的產能將在該時間範圍內全面投入使用，然後滾動該產能向前。

I mean, we'll have a chance to lay out that as we did this year in our guidance call in early February.

But qualitatively, you can see the flow of our investment and CapEx into the space, and you could kind of go backwards 3 years or so and expect the capacities we announced then to be coming on full line and in that time frame and then rolling that forward.

So of course, we made an announcement this year, and those are a couple of years away from having full impact.

當然，我們今年發布了一項公告，距離產生全面影響還需要幾年的時間。但如果你回到 21 年、22 年、23 年，我們正在努力將這些內容上線，並預計明年會有良好的成長。所以我認為盧卡斯提到，我們看到需求加速，但這意味著今年供應加速，我們預計明年總量將強勁增長，我們將列出細節。讓我進入指南。盧卡斯，我不知道你還有什麼要補充的嗎？

But if you go back to '21, '22, '23, we are working hard to bring those online and expect good growth next year.

So I think Lucas mentioned, we're seeing acceleration in demand but that means acceleration in supply during this year, and we expect strong growth on the total for next year, and we'll lay out the details in the guidance call.

I don't know if you have anything else to add to that, Lucas?

Maybe just one comment from my side.

也許只是我這邊的一則評論。當我們從需求角度討論更多時，我認為在美國，特別是我們提到的 Mounjaro 和 Zepbound 的 TRx 環比增長 25% 的代理，這是一個很好的指標，可以從明年開始基本趨勢，而且可以提供比製造商更多的市場方面和需求方面的觀點。

When we talk about more so from the demand perspective, I think in the US, in particular, the proxy that we alluded to on the growth that we see across both Mounjaro and Zepbound in TRx of that 25% sequential quarter-on-quarter, it's a good proxy to start basically trending out into next year, more so to provide more perspective from the market side and the demand side than the manufacturer.

Umer Raffat, Evercore ISI.

烏默·拉法特，Evercore ISI。

Maybe just to spend 1 more minute on the inventory dynamic in the quarter.

也許只是再花一分鐘了解本季的庫存動態。我正在嘗試大聲思考。考慮到推出的進度，透過 LillyDirect 推出現金支付單瓶選項是否會影響通路填充庫存的興趣？和/或您對經銷商的激勵措施或費用是否有任何可能產生影響的變化？

I'm trying to think out loud.

Could the launch of cash pay a single vial option via LillyDirect have impacted channels interest in filling out their inventory given how the launch is going?

And/or were there any changes in your incentives or fees to the distributors that could have impacted it?

I'll let Patrik quickly handle that.

我會讓派崔克快速處理這件事。

Overall, we launched LillyDirect vials just a month ago.

總體而言，我們在一個月前推出了 LillyDirect。我們對這種情況感到高興，但我們也意​​識到醫療保健系統需要一些時間才能在其電子病歷系統中採用自付費用。但到目前為止，我想說 TRx 的影響相當有限，將被定義為較低的個位數水準。我們預計我們的自付費用將成為新療法開始向前發展的一個非常重要的管道，但在第三季並不重要。

We are pleased with the uptake, but we also realize that it takes some time for health care systems to adopt the self-pay in their EMR systems.

But so far, I would say that the impact of TRx has been quite limited and will be defined as being at a low single-digit level.

We expect LillyDirect self-pay to be a very important channel to grow new therapy starts moving forward, but not significant in Q3.

I think the short answer to both your questions is no and no.

我認為對你的兩個問題的簡短答案是否定的。我們沒有改變我們的條款，我認為我們不會看到自動注射器的零售庫存有任何變化，因為它們是付費的。

We didn't change our terms and I don't think we see any change in retail stocking of the auto-injector because the vials new.

Steve Scala, TD Cowen.

史蒂夫·斯卡拉，TD·考恩。

For a product with a seemingly unlimited market opportunity, what appears to be great market awareness and persistent supply shortages, DTC for Zepbound really shouldn't be necessary, particularly now.

對於一個看似擁有無限市場機會、看似市場意識很強且供應持續短缺的產品來說，Zepbound 的 DTC 確實沒有必要，尤其是現在。根據我的經驗，DTC 通常表明對患者數量意識或競爭的擔憂。

DTC, in my experience usually signals concern about patient volumes, awareness, or competition.

So the question is if DTC were not instituted, what would be the trajectory of Zepbound over the next, say, 12 months?

所以問題是，如果 DTC 沒有建立，Zepbound 在接下來的（例如 12 個月）的發展軌跡會是什麼？能否達成共識？如果擔心競爭，您是否會提前發布即將發布的數據？

Would consensus be achieved?

And if competition is the concern, are you getting ahead of cagrisema data due out soon?

That's a lot to unpack, Steve.

有很多東西需要解開，史蒂夫。我認為我們不會圍繞著假設的需求曲線進行推測。但也許——我認為帕特里克在他關於我們現在為什麼要做 DTC 的第一個回答中就談到了這一點。也許只是簡單地重申這一點，帕特里克，大約。

I don't think we're going to speculate around a hypothetical demand curve.

But I think Patrik kind of touched on this in his first answer with regard to why we're doing DTC now.

Maybe just reiterate that point, very briefly, Patrik, around this.

Yes, I think we are comparing a very different market, the first half of '25 versus the second half of 2025.

是的，我認為我們正在比較一個非常不同的市場，即 25 年上半年與 2025 年下半年。那時我們不負責推動任何重大的 DTC 投資，而只是在藥房層面為消費者提供糟糕的體驗。我們現在對未來的供應更有信心。而且這不是需求問題。這其實只是一個供應機會，我們希望提高消費者的意識。

We faced some significant supply constraints.

And it wouldn't be responsible for us at that point in time to drive any major DTC investments and just provide consumers with a bad experience at the pharmacy level.

We have much more confidence now in terms of the supply moving forward.

And this is not a demand issue problem.

It's actually just a supply opportunity, and we want to drive that consumer awareness.

So why we're doing extremely well.

那為什麼我們做得非常好。我們只需要記住，肥胖的滲透率僅為個位數的低水平，即 4% 至 5%。而且還有一個巨大的市場。無論我們在這裡能做什麼來推動患者的積極性，都將非常有利於我們的前進。

We just need to have in mind, but the penetration in terms of obesity is just at a low single-digit level, 4% to 5%.

And there is still a hugestigma.

Whatever we can do here to drive patient activation is going to serve us very well moving forward.

I would just add that actually unaided awareness for Zepbound, although everyone on this call is highly aware of the brand name, is actually not very high and that we launched this drug almost a year ago and have done no advertising.

我想補充一點，儘管我們在這次電話會議上的每個人都非常了解這個品牌名稱，但實際上對Zepbound 的認識並不是很高，而且我們大約一年前推出了這種藥物，並且沒有做過任何廣告。所以我認為是時候介紹這個品牌了，這樣人們在與醫生交談時就會意識到這一點。

So I think it is time to introduce the brand and so people are aware of that when they speak to their doctor.

Dave Risinger, Leerink.

戴夫瑞辛格，萊林克。

Yes.

是的。有人問了我很多問題。因此，關於 parasolumab，我希望您能提供更多的顏色。您提到由於收益風險比而被放棄。但您是否發現任何具體的安全問題？您對未來開發另一種用於 I&I 疾病的 PD-1 激動劑的機會有何看法？

A number of my questions have been asked.

So with respect to peresolimab, I'm hoping that you could just provide a little bit more color.

You mentioned that it was dropped due to the benefit risk ratio.

But did you see any specific safety problems?

And what is your view of the opportunity to develop another PD-1 agonist for I&I disease in the future?

Thanks, Dave.

謝謝，戴夫。我開始擔心丹沒有機會在問答環節發言，所以也許我會把這個交給丹來聽聽他的想法。

And I was getting worried that Dan wouldn't get a chance to speak on the Q&A so maybe I'll hand this over to Dan for his thoughts.

Thanks for the good question, Dave.

謝謝你提出的好問題，戴夫。是的，我的意思是，parasolimib 對我們來說是一個非常有趣的機制，當我們看到 IIa 期數據時，我們很興奮。雖然患者數量較少，但對 RA 症狀產生了相對深遠的影響，特別是對於先前生物製劑失敗的患者。

Yes, I mean, peresolimab was a really interesting mechanism for us, and we were excited when we saw the Phase IIa data.

It was a small number of patients but had a relatively profound effect on RA symptoms particularly in patients who had failed the previous biologics.

So we sought out to replicate that on a larger Phase IIb study.

因此，我們開始在更大規模的 IIb 期研究中複製這一點。不幸的是，當我們結束研究時，我們在 IIa 期研究中看到的獲益風險並未在 IIb 期研究中得到充分證實。

Unfortunately, when we came to the end of that study, the benefit risk that we've seen in the Phase IIa study was not fully borne out in Phase IIb.

So just based on the overall profile, which includes both the efficacy and the safety of the drug, we decided not to pursue that.

因此，僅根據整體概況（包括藥物的功效和安全性），我們決定不追求這一點。至於你關於後續 PD-1 激動劑的問題，我們目前還沒有正在研發的藥物。這就是我要說的。當然，我認為我們將期待在未來的會議上展示完整的資料包。

As to your question on a follow-on PD-1 agonist, we don't have one that we're pursuing right now.

So that's what I'll say about that.

And I think, of course, we'll look forward to presenting the full data package at a future meeting.

Kerry Holford, Berenberg.

凱莉·霍爾福德，貝倫貝格。

Kerry Holford,Berenberg.

貝倫貝格的凱裡·霍爾福德大廳。我的問題實際上是關於 Vesneo 的。因此，您在這個領域的競爭對手諾華最近在早期乳癌領域獲得了廣泛的批准，其中顯然包括高風險患者群體。因此，我很想聽聽您談論您對該領域有效市場份額的期望，以及您如何在高風險環境中保護自己的地位。

My question actually on Verzenio, please.

So your competitor in this space, Novartis Kisqali recently received a broad approval in early breast cancer, which obviously includes the high-risk patient group.

So I would just be interested to hear you speak about your expectations for market share in that space, how you protect your position with Verzenio in the high-risk setting.

And then also if you can talk to the impact of IRA that you expect on that brand as you move through Part D reform next year and whether or not you expect the drug to be on the negotiation list for 2027.

然後，您是否可以談談在明年進行 D 部分改革時您預期 IRA 對該品牌的影響，以及您是否預計該藥物會出現在 2027 年的談判中。

Thanks, Kerry.

謝謝，凱瑞。這是一個由兩部分組成的問題，但我很高興邀請 Jake 插話，也許可以談談展示潛在影響以及 IRA。傑克？

Sort of a 2-part question but I'm excited to ask Jake to chime in and maybe talk about Verzenio and the potential Kisqali impact as well as IRA.

Jake?

Yes.

是的。很高興接受它。謝謝你的提問。我們對 Verzenio 與 Kisqali 佐劑設定的市場份額的立場和期望與現在相比並沒有真正改變預先批准的情況。我認為我們有一個非常強大的臨床數據包，對我們的數據集進行了大量的跟踪，這對於處方者和兩年的治療方案至關重要，患者可以在其中完成輔助治療並繼續他們的生活，希望能夠繼續下去無復發。

Happy to take it.

Thanks for the question.

Our position and expectation here around market share with respect to the adjuvant setting for Verzenio versus Kisqali hasn't really changed sort of pre-approval versus now.

I think we have a very robust clinical data package with a lot of follow-up on our data set, which is critically important for prescribers and a 2-year regimen where patients can finish their adjuvant therapy and move on with their life, hopefully remaining recurrence-free.

That's a pretty compelling proposition.

這是一個非常引人注目的提議。我認為在各種治療指南中已經認識到，對於高風險族群（MONARCH E 患者族群），更喜歡 Verzenio，而不是標準照護規模。這些專家指南在過去幾個月中發揮了重要作用。我預計這種情況不會發生實質改變。當然，隨著新的市場進入者的出現，接受 CDK4/6 抑制劑作為輔助治療的患者比例可能會上升，這將使我們受益。

It has been and I think is recognized as such in a variety of treatment guidelines that for the high-risk population, the MONARCH-E patient population, prefer Verzenio over Kisqali as standard of care.

Those expert guidelines have weighed in over the past couple of months.

I don't expect that to change materially.

Of course, with a new market entrant, the percentage of patients in this setting who get any CDK4/6 inhibitor as adjuvant therapy could go up and that would benefit us.

And I expect that there will be some patients for whom Kisqali is a more appropriate choice, but I don't expect it to be a significant shift in our overall market dynamics.

我預期對於某些患者來說，Kisqali 是更合適的選擇，但我不認為這會對我們的整體市場動態產生重大轉變。當然，節點陰性群體並不是我們被指示的地方，也不是我們被使用的地方，這是他們要講述的故事。

And of course, the node-negative population is not where we're indicated, and not where we’re used and that's a story for them to tell.

On the second part of your question around Part D reform, it will have an impact.

關於你關於 D 部分改革的問題的第二部分，它將產生影響。當然，我們必須為災難性保險繳納的金額存在推拉，這是一個缺點，當然，患者的自付費用上限，特別是在醫療保險方面，這可能是一個順風車關於這個品牌，我認為很難確切地知道它會帶來什麼結果。它可能會在中性範圍內發揮作用。我認為這最終不會成為整體的逆風或順風，但我們必須看看它會如何發展。

Of course, there's a push and pull here on the amount we have to contribute for catastrophic coverage being a downside and of course, the co-pay cap out-of-pocket cap on patients, particularly in Medicare, where that could be a tailwind on the brand I think it's hard to know exactly where that will net out.

It probably nets out sort of in the neutral range.

I don't think it will end up being a headwind or tailwind sort of in totality, but we have to see how that shakes out.

On the last part of your question around negotiation list, I don't want to speculate on that.

關於你關於談判清單的問題的最後一部分，我不想對此進行猜測。考慮到所有不同藥物的不斷發展性質，我認為我們還沒有足夠的信息，這些藥物可能需要進行談判，以某種方式實際說明哪些藥物將會出現。

I don't think we have enough information yet given the evolving nature of all of the different medicines that could be up for negotiation to actually say one way or another, which ones will be there just yet.

Thank you, Jake.

謝謝你，傑克。我知道我們的時間不多了。保羅，也許還有 2 到 3 個問題。

I know we're running short on time.

So Paul, maybe just 2 or 3 more questions.

Chris Shibutani, Goldman Sachs.

克里斯·澀谷，高盛。

Lucas, welcome to these calls.

盧卡斯，歡迎來電。只是好奇，營業利潤率之間存在一點緊張點，我知道禮來公司使用的是一種非常獨特且具體的精確計算方法，大多數人至少在賣方中進行長期預測，接近 40% 。

Just curious, there's a little bit of a tension point between of what the operating margins, and I know Lilly uses a very unique and specific precise calculus for that with most people longer term forecasting at least amongst the sell side, approaching high 40s percent.

And I believe some of your commentary suggested that perhaps that would not be where you would aim for.

我相信您的一些評論表明也許這不是您的目標。您能否向我們澄清一下您的觀點以及您對營業利潤率軌跡將在您的職權範圍內的看法？

Can you just maybe clarify for us your view, your take on where you think the operating margin trajectory would go under your purview?

Well, Lucas, go ahead.

好吧，盧卡斯，繼續吧。

Yes.

是的。對不起。克里斯，謝謝你提出問題，也謝謝你打電話給我詢問這個新的比率。毛利率減去營運支出除以收入是一個相當長的比率。但只要回答你的問題。從短期來看，您會看到我們在過去幾季中的比率有所提高，因為我們一直處於顯著成長軌蹟的周期中，我們開始增加在銷售、行政管理和研發方面的投資。這種影響肯定會持續到今年第四季。這是我們指南的一部分。

Thank you, Chris, for your question, and thank you for calling me about this new ratio.

The gross margin minus OpEx divided by revenue is quite a lengthy ratio.

But just going to your question.

In the short run, you see that we have grown our ratio in the last few quarters as we have been having this cycle of significant growth trajectory, and we are starting to ramp up our investment, both in SG&A and R&D.

That effect will continue for sure getting into the fourth quarter of the year.

That is included as part of our guidance.

And what we expect to see moving into 2025, going into your question is we do expect to ramp up our demand generation activities in SG&A that will pay down into 2025 as well as we will scale our R&D.

進入 2025 年，我們確實希望加強 SG&A 的需求產生活動，這將在 2025 年實現回報，並且我們將擴大研發規模。我們討論了我們投資組合中進入第二階段和第三階段的一些資產，隨著我們增加這些投資以推動長期可持續成長，這些資產將繼續發揮作用。

We talked about some of the assets in our portfolio that moves into Phase II and Phase III that will continue to play out as we ramp up those investments to drive long-term sustainable growth.

So I would expect that in the short term, we continue to see some operating margin expansion on this ratio.

因此，我預計在短期內，我們將繼續看到該比率的營業利潤率擴大。從長遠來看，我們將再次繼續擴張並推動永續成長。這基本上證明了我們在銷售、行政管理和研發方面的投資是合理的。

In long term, again, we will continue to expand and drive sustainable growth.

That would basically justify the investments that we do in SG&A and R&D.

Trung Huynh, UBS.

Trung Huynh，瑞銀。

So in your PR, you note favorable changes to estimates for rebates and discounts for Mounjaro.

因此，在您的 PR 中，您注意到 Mounjaro 的回饋和折扣預估發生了有利的變化。如果你根據我們的數據，如果你排除中個位數的庫存，那麼該產品的價格看起來確實在今年有所上漲。 Zepbound 的定價看起來也相當穩定。因此，也許您可以談談今年剩餘時間以及明年的定價演變情況，因為標籤上可能會出現睡眠呼吸中止症和 HFPEF，這可能意味著您會進入更多的政府機構。

On our numbers, if you ex-out mid-single-digit destock, it does look like price has gone up for the year for that product.

Also Zepbound pricing looks pretty stable.

So perhaps can you just talk about what you see in pricing evolution for the rest of the year but also next year as you'll have potentially sleep apnea and HFPEF on the label, which may mean that you go into more government settings.

Lucas, you like to talk kind of high level or any net pricing dynamics worth sharing?

盧卡斯，您喜歡談論高層或任何值得分享的淨定價動態嗎？

Yes, sure.

是的，當然。感謝您提出的問題。回到今年到目前為止的 Mounjaro，我們全年都發出信號，一旦我們去年取消了自付費用計劃，我們將看到價格與去年同期相比基本上是順風順水結果正如我們所預期的那樣。當然，日落也需要一點時間才能看到這一點。

And thank you for the questions.

Going back to the Mounjaro so far in the year, we kind of signaled throughout the year that once we were sunsetting last year the co-pay program that we had, that we will see that basically tailwind on the price year-on-year comparison that played out as what we expected.

And the sunset of course, takes again a little bit of time to see that playing out.

So you see a little bit of that spillover effect into Q3.

因此，進入第四季度您會看到一些溢出效應，但我們預計不會看到重大動態。您在第三季開始看到的基本上就是我們預計到今年第四季的情況。也許要討論睡眠呼吸中止症指示的策略，派崔克，您在這方面有什麼意見嗎？

Getting into Q4, we don't expect to see major dynamics on that.

And what you're starting to see basically in Q3 is what we project into the fourth quarter of the year.

Maybe getting into the strategy to sleep apnea indication, any comments that you would like to add, Patrik, on that front?

I would just say, in terms of Zepbound, we are still very early on in launch.

我只想說，就 Zepbound 而言，我們仍處於發布的早期階段。我認為您澄清了第三季度相對於第二季度的定價穩定性，盧卡斯。我們需要牢記的是，我們將繼續增加存取權限。我們現在也將看到在美國以外的地區推出快筆，並獲得批准，這也可能影響未來的全球淨定價動態。

And I think you clarified the stability in pricing, Q3 over Q2, Lucas.

What we need to have in mind is that we will continue to increase access.

We will see launches outside of the US as well now with Kwikpen being approved and also can impact the global net pricing dynamics moving forward.

Maybe last question, Paul, and then we'll wrap up.

也許是最後一個問題，保羅，然後我們就結束了。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

Coming back to obesity and perhaps looking a little longer term, you spoke to the ATTAIN-MAINTAIN trial off the back of SURMOUNT-5.

回到肥胖問題，或許從長遠來看，您在 SURMOUNT-5 的支持下談到了 ATTAIN MAINTAIN 試驗。我注意到對於 orforglipron，這是安慰劑對照的。我只是想了解一下您對比較器的看法。

I note that for orforglipron, this is placebo-controlled.

And I just wanted to kind of get your thoughts on kind of that being the comparator.

For us, kind of that being the comparator suggests that this is about kind of duration of treatment, expansion to patients, which would really be an expansion of the total market rather than kind of displacement of necessarily another obesity product.

對我們來說，作為比較器表明這與治療的持續時間、向患者的擴展有關，這實際上是整個市場的擴展，而不是必然另一種肥胖產品的替代方案。您能簡單談談 orforglipron 以及它如何擴大市場的未來嗎？

Can you just talk a little bit about orforglipron and kind of the future of how this could expand the market?

Yes.

是的。謝謝 Courtney 關於 orfo 的問題。也許我會請派崔克在一些商業——潛在的商業策略和 ATTAIN MAINTAIN 試驗中討論這一點。感謝您注意到這一點。派崔克？

Thanks, Courtney, for the question on orfo.

Maybe I'll hand to Patrik to talk about that in some of the potential commercial strategy and the ATTAIN-MAINTAIN trial.

Thank you for noticing that.

Patrik?

Thank you very much, Courtney.

非常感謝你，考特尼。但我們期待明年（2025 年）orfo III 期試驗的結果。如果我們按照我們在第二階段中看到的那樣提供與注射劑、索馬魯肽類似的功效，這將是第一個口服藥物。所以我認為這將使我們真正能夠在全球範圍內擴展。我們正在避免冷鏈要求等。

We are looking forward to the readout of the orfo Phase III trials next year, 2025.

But I think overall, we see a significant opportunity here.

It's going to be the first oral if we deliver on the lines that we saw in Phase II with an efficacy along the lines of an injectable, along the lines of semaglutide.

So I think that will really position us to scale globally.

We are avoiding the cold chain requirements, et cetera.

But also in the US, we see an opportunity to further penetrate because we know that even if the experience with the auto-injector, once you have tried it, it's really good.

而且在美國，我們看到了進一步滲透的機會，因為我們知道，即使使用自動注射器的經驗，一旦你嘗試過，它真的很好。我們知道市場上有一根針，但可能影響 20% 到 25% 的人口。所以我認為有一個巨大的擴展機會。

We know that there is a needle fear in the marketplace that probably impacts 20% to 25% of the population.

So I think there is a huge opportunity to expand.

When you refer particularly to ATTAIN-MAINTAIN, I think there is an obligation on our side to really better understand how can you best keep patients on treatment for a longer period of time, knowing that obesity is a chronic disease.

當您特別提到「達到維持」時，我認為我們有義務真正更好地了解如何最好地讓患者接受更長時間的治療，因為我們知道肥胖是一種慢性疾病。這就是為什麼我們依靠一些維護來看看失去了哪些有效的方法可以讓患者保持更長的時間。

That's why we're leaning in on some of MAINTAIN to see what is the most efficacious dose that you can keep patients on during a longer time.

And similarly, with ATTAIN-MAINTAIN, we don't expect a major shift by clinicians from injectables to orals.

同樣，對於 ATTAIN MAINTAIN，我們預計臨床醫生不會對注射車產生重大轉變。我認為這是繼續治療患者或他們需要接受藥物治療的一種選擇，這是一種慢性疾病，我們正在盡一切努力改善我們的治療結果並改善患者的治療結果。

And I think this is one alternative to continue treat patients over the periods they need to be on medication, which is a chronic disease, and we are doing whatever we can to improve patient outcomes.

Great.

偉大的。好的。謝謝你，派崔克，我想我們已經結束了，戴夫。

All right.

Thank you, Patrick, and I think we're wrapping up, Dave.

Okay.

好的。偉大的。好的，謝謝大家今天加入我們。在結束這次電話會議時，我想感謝喬·弗萊徹 (Joe Fletcher)，他即將從 IR 主管職位調任到一個新職位，即製造部門首席財務官 (CFO) 的關鍵職位。我想你們都同意喬在過去的許多年裡在代表禮來公司（Lilly）走向華爾街方面做得非常出色，我們歡迎邁克·薩帕爾（Mike Sapar）擔任這個角色，在經歷了各種業務輪換後實際上回到了IR，這將是一個激動人心的未來邁克作為您的主要聯繫人。

Great.

Well, thank you for joining us today, everyone.

I want to end the call by just thanking Joe Fletcher, who is moving on from his role as Head of IR to a new role, a critical role of CFO of Manufacturing.

I think you all agree Joe did a great job in representing Lilly to the Street over the last many years, and we welcome Mike Czapar into the role, returning to IR actually after various rotations in the business, and it will be an exciting time ahead with Mike as your main point of contact.

So thank you all for joining us today.

感謝大家今天加入我們。像往常一樣，如果您有後續問題，請致電 IR 團隊，並期待在接下來的幾個月與大家見面。小心。

And as usual, if you have follow-up questions, please give us a call at the IR team and look forward to seeing everyone on the road over the coming months.

Take care.

And ladies and gentlemen, this does conclude our conference for today.

女士們、先生們，我們今天的會議到此結束。本次會議將從今天下午 1:00 開始重播，一直持續到 12 月 4 日午夜。您可以隨時撥打 800 332-6854 並輸入存取代碼 987290 存取重播系統。同樣，這些號碼為 800 332-6854 和 973 528-0005，接入碼為 987290。現在您可以斷開線路。

This conference will be made available for replay beginning at 1:00 PM today running through December 4 at midnight.

You may access the replay system at any time by dialing 800 332-6854 and entering the access code 987290.

International dollars can call 973 528-0005.

Again, those numbers are 800 332-6854 and 973 528-0005 with the access code 987290.

Thank you for your participation.

You may now disconnect your lines.