禮來公司 (LLY) 2024 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q4 2024 earnings call.

女士們，先生們，感謝大家的支持，歡迎參加禮來公司 2024 年第四季財報電話會議。

(Operator Instructions)

（操作員指令）

I would now like to turn the conference over to your host, Mike Czapar, Senior Vice President of Investor Relations.

現在，我想將會議交給主持人、投資者關係高級副總裁 Mike Czapar。

Mike, please go ahead.

麥克，請說。

Good morning.

早安.

Thank you for joining us for Eli Lilly and Company's Q4 2024 earnings call.

感謝您參加禮來公司 2024 年第四季財報電話會議。

I'm Mike Czapar, Senior Vice President of Investor Relations.

我是投資者關係資深副總裁 Mike Czapar。

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.

參加今天電話會議的還有禮來公司董事長兼執行長 Dave Ricks；禮來免疫學首席科學官兼總裁 Dan Skovronsky 博士；盧卡斯‧蒙塔斯 (Lucas Montarce)，財務長；禮來神經科學公司總裁 Anne White；禮來國際總裁 Ilya Yuffa；禮來腫瘤學總裁傑克‧範納爾登 (Jake Van Naarden)；以及禮來心臟代謝健康和禮來美國總裁 Patrik Jonsson。

We're also joined by Mart Keenan, Wes Taul, and Wai Wong of the investor relations team.

我們也邀請了投資者關係團隊的 Mart Keenan、Wes Taul 和 Wai Wong 參與。

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

在電話會議中，我們預計將根據當前的預期做出預測和前瞻性陳述。

Our actual results could differ materially due to several factors, including those listed on slide 4.

我們的實際結果可能由於多種因素而存在重大差異，包括投影片 4 中列出的因素。

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.

有關可能導致實際結果大不相同的因素的更多信息，請參閱我們最新的 10-K 表格以及隨後向美國證券交易委員會提交的文件。

The information we provide about our products and pipeline is for the benefit of the investment community.

我們提供的有關我們的產品和管道的資訊是為了投資界的利益。

It is not intended to be promotional and is not sufficient for prescribing decisions.

它並非旨在用於宣傳，且不足以用於規定決策。

As we transition to our prepared remarks, please note that our commentary will focus on our non-GAAP financial measures.

當我們轉到準備好的評論時，請注意我們的評論將集中於我們的非公認會計準則財務指標。

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

現在，我將電話轉給戴夫。

Okay.

好的。

Thanks, Mike.

謝謝，麥克。

2024 was a productive year for Lilly.

2024 年對禮來公司來說是豐收的一年。

We grew our top line, advanced our pipeline, and invested in our supply chain to meet the increasing demand for our medicines.

我們擴大了營業收入，改善了產品線，並投資了供應鏈，以滿足日益增長的藥品需求。

Most importantly, we delivered for patients by bringing life-changing medicines to more people around the world.

最重要的是，我們為世界各地更多人提供了改變生活的藥物，從而為患者帶來了福祉。

In 2024, full-year revenue grew 32% compared to 2023, exceeding our first-time guidance by $4 billion.

2024 年全年營收較 2023 年成長 32%，超過我們的首次預期 40 億美元。

Revenue grew 45% in the most recent quarter as our recently launched products gained momentum.

由於我們近期推出的產品發展勢頭強勁，最近一個季度的營收成長了 45%。

Last year, we announced positive Phase 3 results for imlunestrant, insulin efsitora alfa, and three additional tirzepatide trials.

去年，我們宣布了 imlunestrant、胰島素 efsitora alfa 和另外三項 tirzepatide 試驗的 3 期正面結果。

We also started Phase 3 programs for lepodisiran, remternetug, and olomorasib based on positive earlier-phase data.

根據早期階段的正面數據，我們也啟動了 lepodisiran、remternetug 和 olomorasib 的 III 期研究計畫。

We continued to complement our pipeline through acquisitions and collaborations.

我們繼續透過收購和合作來補充我們的產品線。

We acquired Morphic Therapeutics and announced a collaboration with OpenAI to invent novel antimicrobials.

我們收購了 Morphic Therapeutics，並宣布與 OpenAI 合作發明新型抗菌藥物。

We opened the Lilly Seaport Innovation Center in Boston as a hub for Lilly's genetic medicines efforts and announced a new Lilly Gateway Lab in the UK to collaborate with European researchers.

我們在波士頓開設了禮來海港創新中心，作為禮來基因藥物工作的樞紐，並宣佈在英國建立新的禮來門戶實驗室，與歐洲研究人員合作。

We advanced our manufacturing agenda, announcing investments to expand our footprint in Indiana, in Wisconsin, and in Ireland.

我們推進了製造業議程，宣布投資擴大我們在印第安納州、威斯康辛州和愛爾蘭的足跡。

Since 2020, our commitments to build, expand, and acquire manufacturing facilities now total more than $23 billion.

自 2020 年以來，我們用於建造、擴建和收購製造設施的承諾總額已超過 230 億美元。

Importantly, we brought innovative new medicines to patients.

重要的是，我們為患者帶來了創新的新藥。

In 2024, we received regulatory approvals for Kisunla, Ebglyss, and a new indication for Zepbound in OSA.

2024 年，我們獲得了 Kisunla、Ebglyss 的監管批准，以及 Zepbound 在 OSA 中的新適應症。

This progress strengthens our portfolio of new products and enhances our capacity to drive top-tier growth and margin expansion.

這項進展增強了我們的新產品組合，增強了我們推動頂級成長和利潤擴大的能力。

As you can see on slide 5, we continue to make progress against our strategic deliverables in Q4.

正如您在投影片 5 上看到的，我們在第四季的策略交付方面繼續取得進展。

Revenue grew 45% and our new products growing by more than $3.1 billion, led by a strong uptake of Mounjaro and Zepbound.

營收成長了 45%，我們的新產品成長了 31 億美元以上，其中 Mounjaro 和 Zepbound 的銷量強勁成長。

Q4 also saw solid performance across oncology, immunology, and neuroscience.

Q4 在腫瘤學、免疫學和神經科學領域也表現穩健。

Our business excluding incretins grew by 20% in the quarter compared to Q4 2023, excluding the one-time benefits of business development.

與 2023 年第四季相比，本季我們不包括腸促胰島素的業務成長了 20%，不包括業務發展的一次性收益。

Since our last earnings call, we achieved several key pipeline milestones.

自上次財報電話會議以來，我們已實現幾個關鍵的管道里程碑。

We received approval for a new indication of Zepbound and Omvoh.

我們獲得了 Zepbound 和 Omvoh 新適應症的批准。

We submitted imlunestrant for metastatic breast cancer and tirzepatide for heart failure.

我們提交了用於治療轉移性乳癌的伊瑪尼司他汀和用於治療心臟衰竭的替澤帕肽。

We also announced positive Phase 3 results in the SURMOUNT-5 study, where Zepbound demonstrated a 47% greater relative weight loss compared to Wegovy.

我們也發表了 SURMOUNT-5 研究的第三階段正面結果，其中 Zepbound 與 Wegovy 相比，相對減重效果提高了 47%。

We strengthened our overall supply position and delivered on our production target to make 1.5 times the saleable doses of incretin medicines in the second half of '24 compared to the second half of '23.

我們加強了整體供應地位，並實現了生產目標，即 2024 年下半年生產的腸促胰島素藥物可銷售劑量是 2023 年下半年的 1.5 倍。

With more patients using LillyDirect, the uptake of single-use Zepbound vials increased.

隨著越來越多的患者使用 LillyDirect，一次性 Zepbound 小瓶的使用量也隨之增加。

We had no wholesaler back orders as we closed 2024, and wholesalers have been fulfilling orders from pharmacies at very high levels.

當我們在 2024 年結束時，我們沒有批發商積壓訂單，而且批發商一直在以非常高的水平履行藥房的訂單。

We continue to augment our internal pipeline with external innovation, announcing plans to acquire Scorpion Therapeutics' mutant-selective PI3Ka inhibitor program.

我們繼續透過外部創新擴充我們的內部產品線，並宣布計劃收購 Scorpion Therapeutics 的突變選擇性 PI3Ka 抑制劑專案。

This transaction will add a clinical-stage breast cancer asset to our oncology pipeline.

此次交易將為我們的腫瘤學產品線增加一項臨床階段的乳癌資產。

And lastly, we returned $3 billion to shareholders via dividends and share repurchases.

最後，我們透過股利和股票回購向股東返還了 30 億美元。

In addition to that, we announced at the end of the year a $15 billion share repurchase program and the seventh consecutive 15% increase in our quarterly dividend.

除此之外，我們在年底宣布了一項 150 億美元的股票回購計劃，並連續第七次將季度股息提高 15%。

On slide 6, you'll see a full list of key events since our Q3 call, including the milestones I mentioned here, and several other updates.

在第 6 張投影片上，您將看到自我們第三季電話會議以來的關鍵事件的完整列表，包括我在此處提到的里程碑和其他一些更新。

Now, I'd like to turn the call over to Lucas to review our Q4 and 2024 full-year results and provide details on the '25 guidance.

現在，我想將電話轉給盧卡斯，讓他回顧我們第四季和 2024 年全年業績，並提供有關 25 年指引的詳細資訊。

Thanks, Dave.

謝謝，戴夫。

Slide 7 summarizes our financial performance in the fourth quarter and slide 8 for the full year.

投影片 7 總結了我們第四季的財務業績，投影片 8 總結了全年的財務表現。

As Dave mentioned, our revenue grew 45% in Q4, primarily driven by Mounjaro and Zepbound.

正如戴夫所提到的，我們的收入在第四季度增長了 45%，主要得益於 Mounjaro 和 Zepbound。

Performance of our non-incretin portfolio was also strong as revenue grew 20%, excluding one-time payments related to business development.

我們的非腸促胰島素產品組合表現強勁，營收成長了 20%，不包括與業務發展相關的一次性付款。

Gross margin as a percentage of revenue increased to 83.2% in Q4, primarily impacted by favorable product mix.

第四季毛利率佔營收的百分比增加至 83.2%，主要受到有利的產品組合的影響。

R&D expenses increased 18% from continued investment in our early and late-stage portfolio.

由於我們對早期和後期投資組合的持續投資，研發費用增加了 18%。

In total, we started eight new Phase 3 programs in 2024 and advanced several new assets into the clinic.

總體而言，我們於 2024 年啟動了八個新的 3 期項目，並將幾項新資產推進到臨床上。

Marketing, selling, and administrative expenses increased 26%, mainly driven by promotional efforts to support ongoing and future launches.

行銷、銷售和管理費用增加了 26%，主要由於為支援當前和未來推出的產品而進行的促銷活動。

This includes US direct-to-consumer advertising on Zepbound and Mounjaro and US launch activities for Kisunla and Ebglyss.

這包括在美國 Zepbound 和 Mounjaro 上進行的直接面向消費者的廣告以及在美國為 Kisunla 和 Ebglyss 開展的發布活動。

We also increased our commercial investment outside the US to support international launches of Mounjaro.

我們也增加了美國以外的商業投資，以支持 Mounjaro 的國際推廣。

Operating income more than doubled, increasing to $5.6 billion, driven by higher revenue from new products.

受新產品收入增加的推動，營業收入成長一倍多，增至 56 億美元。

The effective tax rate was 13.2%.

有效稅率為13.2%。

We delivered earnings per share of $5.32, inclusive of $0.19 of acquired IPR&D charges.

我們實現每股收益 5.32 美元，其中包括 0.19 美元的收購智慧財產權與開發費用。

This compares to $2.49 in Q4 2023 that includes $0.62 of acquired IPR&D.

相比之下，2023 年第四季的營收為 2.49 美元，其中包括 0.62 美元的收購 IPR&D。

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

在投影片 9 上，我們量化了價格、費率和數量對收入成長的影響。

US revenue increased 40% in Q4, driven by robust volume growth of 45%.

受 45% 強勁銷量成長的推動，美國第四季營收成長了 40%。

Zepbound and Mounjaro were again the largest growth contributors, partially offset by declines in Trulicity.

Zepbound 和 Mounjaro 再次成為成長的最大貢獻者，但 Trulicity 的下滑部分抵消了這一增長。

Realized prices decreased 5% in the US due to favorable changes to estimate for rebates and discounts related to Mounjaro in Q4 2023.

由於 2023 年第四季與 Mounjaro 相關的回扣和折扣預估出現有利變化，美國的實際價格下降了 5%。

Europe revenue grew 82% in constant currency.

以固定匯率計算，歐洲收入成長了 82%。

We continue to be pleased with the uptake of Mounjaro and have now launched in all major European markets.

我們對 Mounjaro 的接受度持續成長感到非常高興，目前該品牌已在所有主要的歐洲市場推出。

In addition to growth from Mounjaro, European revenue benefited from one-time payment associated with the amendment of our alliance with Boehringer Ingelheim.

除了 Mounjaro 帶來的成長之外，歐洲收入還受益於與勃林格殷格翰聯盟修訂相關的一次性付款。

This was recorded in Jardiance revenue in Q4.

這記錄在 Jardiance 第四季的收入中。

Excluding this one-time payment, Europe revenue grew 61%.

除去這筆一次性付款，歐洲收入成長了61%。

Japan revenue grew 27% in constant currency.

以固定匯率計算，日本收入成長了 27%。

Volume growth was driven by Mounjaro, Omvoh, Jardiance, and Verzenio.

銷售成長主要得益於 Mounjaro、Omvoh、Jardiance 和 Verzenio。

In China, revenue increased 13% in constant currency.

在中國，以固定匯率計算收入成長了 13%。

Tyvyt and Verzenio drove volume growth.

Tyvyt 和 Verzenio 推動了銷售成長。

Mounjaro was recently made available in China and will proceed with a limited launch as supply becomes available.

Mounjaro 近期已在中國上市，並將在供應充足的情況下進行限量發售。

We expect modest initial Mounjaro sales in China due to supply limitations, a more meaningful contribution in the second half of 2025.

由於供應限制，我們預期 Mounjaro 在中國的初期銷售會比較溫和，但在 2025 年下半年將帶來更有意義的貢獻。

Revenue in the rest of the world grew 46% in constant currency, driven by volume growth of Mounjaro and Verzenio.

受 Mounjaro 和 Verzenio 銷售成長的推動，世界其他地區的營收以固定匯率計算成長了 46%。

Slide 10 provides an update on our performance of new and growth products.

投影片 10 介紹了我們新產品和成長產品的表現最新情況。

New products more than doubled in Q4 to $5.6 billion, led by global Mounjaro sales of $3.5 billion and US Zepbound sales of $1.9 billion.

第四季新產品銷售額成長一倍多，達到 56 億美元，其中 Mounjaro 全球銷售額達 35 億美元，美國 Zepbound 銷售額達 19 億美元。

US Zepbound performance is going very well.

美國 Zepbound 的演出進展順利。

We began promotional activities this quarter and we continue to see strong uptake.

我們本季開始了促銷活動，並且繼續看到強勁的成長勢頭。

In Q4, Zepbound became the market leader in the anti-obesity market as measured by new prescriptions.

第四季度，以新處方量衡量，Zepbound 成為抗肥胖市場的領導者。

As shown in slide 11, the combined US incretin analog market grew 45% compared to Q4 2023.

如投影片 11 所示，與 2023 年第四季相比，美國腸促胰島素類似物市場整體成長了 45%。

We increased 3 percentage points in share of market in Q4 2024.

2024 年第四季度，我們的市佔率增加了 3 個百分點。

Jaypirca worldwide revenue was $114 million, adding another solid quarter of sequential revenue growth.

Jaypirca 全球營收為 1.14 億美元，連續一個季度實現穩健營收成長。

Worldwide Omvoh revenue increased to $57 million.

Omvoh 全球營收增至 5,700 萬美元。

With the recent FDA approval in Crohn's disease, we look to drive broader use in an additional patient population.

隨著 FDA 最近批准該藥物用於治療克羅恩病，我們希望推動該藥物在更多患者群體中的更廣泛應用。

The Kisunla launch is progressing well, and prescriptions in the US have been steadily increasing.

Kisunla 的上市進展順利，美國的處方量穩定增加。

While it is early, we saw positive momentum across key indicators, including volume of diagnostic ordered, access in priority integrated health systems, coverage by Medicare and commercial plans, and number of infusion sites placing orders.

雖然還處於早期階段，但我們看到關鍵指標呈現積極勢頭，包括診斷訂單量、優先綜合醫療系統的可及性、醫療保險和商業計劃的覆蓋範圍以及下訂單的輸液站點數量。

We are encouraged by the launch of Ebglyss in the US.

Ebglyss 在美國的推出令我們感到鼓舞。

We saw early positive receptivity and high levels of physician engagement.

我們看到了早期的積極接受度和醫生的高參與度。

In addition, we expect commercial access with two of the largest RMAP benefit managers beginning in March.

此外，我們預計從 3 月開始與兩家最大的 RMAP 福利管理公司進行商業合作。

We now plan an accelerated investment in commercial activities to drive new patient start.

我們現在計劃加速對商業活動的投資，以推動新患者的開始。

Growth products also perform well, as revenue increased by 13% compared to Q4 2023.

成長產品的表現也很好，與 2023 年第四季相比，營收成長了 13%。

Verzenio's growth trajectory continued as US total prescription grew by 15%.

隨著美國總處方量增加 15%，Verzenio 的成長軌跡仍在繼續。

In addition to strong execution in the early breast cancer indication, Verzenio revenue benefited from increased US wholesale stock at year-end.

除了在早期乳癌適應症方面的強勁表現外，Verzenio 的收入還受益於年底美國批發庫存的增加。

Worldwide Trulicity revenue declined 25%, driven by Mounjaro switches and, to a lesser extent, lower realized prices.

受 Mounjaro 轉換率下降以及（但程度較小）實際價格下降的影響，Trulicity 全球收入下降了 25%。

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

在第 12 張投影片上，我們提供了有關資本配置的最新資訊。

Moving to slide 13 and 14, I will discuss our 2025 financial guidance.

在投影片 13 和 14 上，我將討論我們的 2025 年財務指引。

As previously shared, we expect 2025 revenue to be between $58 billion and $61 billion.

如同先前所述，我們預計 2025 年的營收將在 580 億至 610 億美元之間。

The midpoint represents approximately 32% growth compared to 2024.

與 2024 年相比，中點成長約 32%。

We anticipate continued US incretin class growth, consistent with the trajectory of total prescriptions seen in 2024.

我們預期美國腸促胰島素類藥物將持續成長，與 2024 年總處方量的走勢一致。

We expect to launch Mounjaro in new markets outside the US and Europe throughout the year.

我們預計全年將在美國和歐洲以外的新市場推出 Mounjaro。

Mounjaro international revenue will contribute to overall performance more significantly in the second part of 2025.

2025 年下半年，Mounjaro 的國際營收將為整體業績做出更大貢獻。

Given the uptake of newer incretins, we expect Trulicity volume to continue declining as fewer new patients are starting on Trulicity.

鑑於新型腸促胰島素的吸收，我們預期 Trulicity 的銷量將繼續下降，因為開始使用 Trulicity 的新患者越來越少。

We expect oncology, neuroscience, and immunology to also grow revenue in 2025, as Ebglyss, Jaypirca, Omvoh, and Kisunla launch uptakes continue.

隨著 Ebglyss、Jaypirca、Omvoh 和 Kisunla 的持續推出，我們預計腫瘤學、神經科學和免疫學的收入也將在 2025 年成長。

At the portfolio level, we anticipate foreign exchange to be a headwind as the dollar has strengthened relative to other currencies.

在投資組合層面，我們預期外匯將成為一個阻力，因為美元相對其他貨幣走強。

In addition, we forecast overall net prices to decline by mid to high-single digits in percentage terms, including US Part D changes.

此外，我們預測包括美國 D 部分的變化在內的整體淨價格將以百分比形式下降中高個位數。

We continue expanding our manufacturing capacity and estimate to produce 1.6 times the amount of incretin saleable doses during the first half of 2025 compared to the first half of 2024.

我們將繼續擴大生產能力，預計 2025 年上半年生產的腸促胰島素可銷售劑量將是 2024 年上半年的 1.6 倍。

Our facility in Concord is anticipated to begin shipping medicines this year, and we plan to make continued progress on expanding our manufacturing network.

我們位於康科德的工廠預計今年開始運送藥品，我們計劃繼續擴大我們的製造網路。

Our expected ratio of gross margin less OpEx divided by revenue is expected to be between 41.5% and 43.5%.

我們預計毛利率減去營運支出除以收入的比率在 41.5% 到 43.5% 之間。

At the midpoint, this reflects approximately 340 basis points of margin expansion compared to 2024.

從中點來看，這反映了與 2024 年相比約 340 個基點的利潤率擴大。

In SG&A, we will continue to invest behind our new launches, including direct-to-consumer efforts in the US, to drive new patient activation.

在銷售、一般及行政開支方面，我們將繼續投資於新產品的推出，包括在美國直接面向消費者的舉措，以推動新患者的啟動。

In addition, we plan to increase investment outside the US to support the launches of Mounjaro in new and existing markets.

此外，我們計劃增加美國以外的投資，以支持 Mounjaro 在新市場和現有市場的推出。

In R&D, we plan to accelerate our investment in early and late-phase activities.

在研發方面，我們計劃加快對早期和後期活動的投資。

As Dan will share later, we started eight new Phase 3 programs in 2024 and anticipate that investment in those programs will ramp as the studies enroll patients.

正如丹稍後將分享的那樣，我們將於 2024 年啟動八個新的 3 期研究項目，並預計隨著研究招募患者，對這些項目的投資將會增加。

We also plan to initiate new Phase 3 programs in 2025.

我們也計劃在 2025 年啟動新的第三階段計畫。

While we keep a high bar for what we advance into clinical development, we expect to scale our investment in R&D this year.

在我們對臨床開發的進展保持高標準的同時，我們預計今年將擴大對研發的投資。

Other expenses is expected to be $600 million to $700 million, driven by interest expense.

預計其他支出為 6 億至 7 億美元，主要受利息支出影響。

We estimate our effective tax rate to be approximately 16%.

我們估計我們的有效稅率約為16%。

Earnings per share, or EPS, is expected to be $22.50 and $24 on a non-GAAP basis.

每股盈餘（EPS）預計為 22.50 美元，非 GAAP 基礎為 24 美元。

This doesn't include a forecast for charges related to IPR&D.

這不包括與知識產權與開發相關的費用預測。

Now, I will turn the call over to Dan to highlight our progress in R&D and to provide an overview of potential key events we expect in 2025.

現在，我將把電話轉給丹，重點介紹我們在研發方面取得的進展，並概述我們預計 2025 年可能發生的關鍵事件。

Thanks, Lucas.

謝謝，盧卡斯。

Lilly R&D had another productive quarter.

禮來研發部門又度過了一個有成效的季度。

I'll cover pipeline progress in Q4, then the 2024 key events, and finally provide potential key events for 2025.

我將介紹第四季的管道進展，然後介紹 2024 年的關鍵事件，最後介紹 2025 年的潛在關鍵事件。

Since our last earnings call, two new indications were approved in the US: Zepbound for obstructive sleep apnea in adults with obesity; and Omvoh for moderate to severe Crohn's disease.

自我們上次收益電話會議以來，美國已批准了兩項新的適應症：Zepbound，用於治療肥胖成人阻塞性睡眠呼吸中止症；以及用於治療中度至重度克隆氏症的 Omvoh。

Both approvals are important milestones and mark an expansion in the number of patients who can benefit from each of these medicines.

這兩項批准都是重要的里程碑，標誌著可從這兩種藥物中受益的患者數量的擴大。

Moving to regulatory submissions, we completed submissions in the US and EU for tirzepatide for heart failure and global submissions for imlunestrant for metastatic breast cancer, and for Jaypirca with the BRUIN CLL-321 data.

在監管提交方面，我們在美國和歐盟完成了用於治療心臟衰竭的 tirzepatide 的提交，以及用於治療轉移性乳腺癌的 imlunestrant 的全球提交，以及用於 Jaypirca 的 BRUIN CLL-321 數據的提交。

I'm also pleased to share that we've submitted an update to the Kisunla US label to include the dosing modification data from TRAILBLAZER-ALZ 6, and the FDA has granted this submission a priority review.

我還很高興地告訴大家，我們已經提交了 Kisunla 美國標籤的更新，其中包括 TRAILBLAZER-ALZ 6 的劑量修改數據，並且 FDA 已對此提交給予優先審查。

In our Phase 3 portfolio, we initiated a new program for orforglipron in obstructive sleep apnea.

在我們的第三階段產品組合中，我們啟動了一項針對奧格列丙治療阻塞性睡眠呼吸中止症的新計畫。

This program includes two studies under the same master protocol to evaluate if people with obstructive sleep apnea and obesity can benefit from orforglipron.

該計劃包括同一主協議下的兩項研究，以評估阻塞性睡眠呼吸中止症和肥胖症患者是否可以從奧格列酮中受益。

After Zepbound was approved in the US as the first and only prescription medicine for obstructive sleep apnea, we're excited to explore if an oral GLP-1 can also deliver a benefit in this disease.

在 Zepbound 在美國獲得批准成為首個也是唯一一個治療阻塞性睡眠呼吸中止症的處方藥後，我們很高興探索口服 GLP-1 是否也能對這種疾病有益。

Earlier in the pipeline, we advanced a second oral GLP-1 into Phase 2 in obesity and advanced eltrekibart into Phase 2 for ulcerative colitis.

在早期研發過程中，我們已將第二種口服 GLP-1 推進至肥胖症治療的第 2 階段，並將 eltrekibart 推進至潰瘍性結腸炎治療的第 2 階段。

Three Phase 2 assets and one Phase 1 asset have been discontinued based on clinical readouts.

根據臨床讀數，三項 2 期資產和一項 1 期資產已停止使用。

In Q4, we also began Phase 1 studies for four new molecules, one in each of our therapeutic areas.

在第四季度，我們也開始了四種新分子的 I 期研究，每個治療領域各一個。

Q4 capped off a productive year of advancing new medicines at Lilly.

第四季為禮來公司新藥研發的豐碩成果畫上了圓滿的句點。

In total, over the year, we started eight new Phase 3 programs; we disclosed Phase 3 data from 21 trials, including 17 major publications in top-tier medical journals; we received regulatory approvals for two new medicines, Ebglyss and Kisunla, as well as many new indications around the world; and we added 14 new programs to the early-phase pipeline.

總體而言，我們在這一年中啟動了 8 個新的第三階段計畫；我們揭露了 21 項試驗的 3 期數據，其中包括 17 篇頂尖醫學期刊的主要出版物；我們獲得了兩種新藥Ebglyss和Kisunla的監管批准，以及全球許多新適應症；我們還在早期研發管線中增加了 14 個新項目。

On slide 16, we detail these outcomes for our 2024 milestones.

在投影片 16 上，我們詳細介紹了 2024 年里程碑的成果。

I'm pleased that nearly all of our anticipated milestones came to fruition positively in 2024.

我很高興，我們預期的幾乎所有里程碑都在 2024 年得到了積極實現。

Turning our focus to 2025, slide 17 shows key R&D milestones we expect this year.

將我們的焦點轉向 2025 年，第 17 張投影片展示了我們今年預計的關鍵研發里程碑。

Starting with our late-stage portfolio, we expect to initiate two new Phase 3 programs this year.

從我們的後期投資組合開始，我們預計今年將啟動兩個新的第三階段項目。

First, in oncology, we'll begin an adjuvant non-small cell lung cancer Phase 3 program for our KRAS G12C inhibitor, olomorasib, building on its ability to be administered with immunotherapy.

首先，在腫瘤學方面，我們將啟動 KRAS G12C 抑制劑 olomorasib 的輔助非小細胞肺癌 3 期治療計劃，以增強其與免疫療法聯合使用的能力。

Our current metastatic program is progressing well, and we've aligned with the FDA on our Phase 3 dose through the Project Optimus pathway.

我們目前的轉移性計劃進展順利，並且我們已透過 Project Optimus 途徑與 FDA 就我們的第 3 階段劑量達成協議。

We shared a clinical update at the World Conference on Lung Cancer last fall, and we are encouraged by the ability to safely combine olomorasib with other agents.

去年秋天，我們在世界肺癌大會上分享了臨床最新進展，我們對將奧洛莫拉西布與其他藥物安全結合的能力感到鼓舞。

Our new Phase 3 program will focus on moving to an earlier setting and combining with existing approved agents in both resectable and unresectable KRAS G12C mutant lung cancer to prevent cancer from recurring.

我們新的 3 期計畫將專注於進入早期治療階段，並與可切除和不可切除的 KRAS G12C 突變肺癌中已獲批准的藥物相結合，以防止癌症復發。

The second program is in cardiometabolic health, where we plan to initiate a Phase 3 trial for orforglipron in hypertension, adding to the ongoing trials in type 2 diabetes, obesity, and obstructive sleep apnea.

第二個項目是心臟代謝健康領域，我們計劃啟動奧格列龍在高血壓方面的 3 期試驗，同時我們正在進行第 2 型糖尿病、肥胖症和阻塞性睡眠呼吸中止症的試驗。

I'm excited that this year, we're looking forward to reading out multiple orforglipron trials.

我很高興今年我們期待讀出多個 orforglipron 試驗。

We expect to see data from up to five studies in type 2 diabetes and two studies in obesity.

我們希望看到最多五項第 2 型糖尿病研究和兩項肥胖症研究的數據。

Our goal is to generate efficacy, safety, and tolerability profile that is similar to that of an injectable single-acting GLP-1, but through an orally available medicine.

我們的目標是透過口服藥物產生與注射單效 GLP-1 相似的功效、安全性和耐受性。

The first orforglipron Phase 3 trial to read out will be ACHIEVE-1, which is a 40-week study in patients with type 2 diabetes.

第一個要宣讀的 orforglipron 第 3 期試驗將是 ACHIEVE-1，這是一項針對 2 型糖尿病患者進行 40 週的研究。

These patients have a baseline hemoglobin A1c between 7% and 9.5% and a body mass index of 23 or greater.

這些患者的基線糖化血紅素在 7% 至 9.5% 之間，體重指數為 23 或更高。

The trial utilizes six escalating doses in four-week increments to a maximum dose of 36 milligrams.

試驗採用四周遞增劑量六次，最大劑量為 36 毫克。

Based on prior studies of orforglipron, as well as other GLP-1 therapies, we expect weight loss in people with diabetes to be significantly less than in people living with obesity who do not have diabetes.

根據對奧格列丙以及其他 GLP-1 療法的先前研究，我們預期糖尿病患者的體重減輕幅度將明顯低於沒有糖尿病的肥胖患者。

We anticipate ACHIEVE-1 will read out in Q2 this year, followed by up to four additional type 2 diabetes trials in the second half of 2025 and a potential submission for this indication in 2026.

我們預計 ACHIEVE-1 將在今年第二季公佈，隨後在 2025 年下半年進行最多四項額外的 2 型糖尿病試驗，並可能在 2026 年提交該適應症的申請。

The orforglipron Phase 3 trials in people with obesity, ATTAIN-1 and ATTAIN-2, are expected to read out in Q3 of this year.

Orforglipron 針對肥胖症患者進行的 3 期試驗 ATTAIN-1 和 ATTAIN-2 預計將於今年第三季完成。

These trials will form the basis of our first orforglipron regulatory submissions, which will be for the treatment of obesity, and we expect to occur late in 2025.

這些試驗將成為我們首次向 Orforglipron 提交監管申請的基礎，用於治療肥胖症，我們預計將於 2025 年底進行。

This year, we also expect data from the tirzepatide cardiovascular outcomes study, SURPASS-CVOT.

今年，我們也期待獲得 tirzepatide 心血管結果研究 SURPASS-CVOT 的數據。

Of course, this is an event-based trial, and the timeline is dependent on the accrual of cardiovascular events.

當然，這是一項基於事件的試驗，時間表取決於心血管事件的累積。

We anticipate data in Q3.

我們預計第三季的數據。

While designed to measure both non-inferiority and superiority compared to Trulicity, a positive outcome in either would demonstrate that tirzepatide reduces the risk of cardiovascular outcomes and would support a labeled indication.

儘管旨在衡量與 Trulicity 相比的非劣效性和優越性，但任何一個的積極結果都將證明 tirzepatide 降低了心血管後果的風險並支持標示的適應症。

Late this year, we expect to see the first data from a triple-acting incretin, retatrutide, which combines GLP-1, GIP, and glucagon.

今年晚些時候，我們預計將看到三重作用的腸促胰島素藥物瑞他酮的首批數據，該藥物結合了 GLP-1、GIP 和胰高血糖素。

We believe this potential new medicine can deliver even more weight loss than tirzepatide and could potentially provide additional health benefits.

我們相信這種潛在的新藥可以比替澤帕肽更有效地減肥，並可能提供額外的健康益處。

The initial study to read out, TRIUMPH-4, is a 68-week study in patients with osteoarthritis of the knee who have a body mass index of 27 or greater.

初步研究 TRIUMPH-4 是針對體重指數為 27 或更高的膝關節骨性關節炎患者進行的一項為期 68 週的研究。

We'll also see multiple additional Jaypirca data sets this year.

今年我們還將看到多個額外的 Jaypirca 資料集。

Physician feedback is very positive on experience with Jaypirca in the currently approved indications, and we hope that generating data in earlier lines of therapy will enable broader use within CLL and MCL.

醫生對於 Jaypirca 在目前批准的適應症中的使用體驗的反饋非常積極，我們希望在早期治療方法中產生的數據將使其在 CLL 和 MCL 中得到更廣泛的應用。

We could see data from additional trials in the first line or BTK-naive settings this year.

我們今年可以看到來自一線或 BTK 初治環境中的更多試驗的數據。

Moving to neurodegeneration, while we don't have a key event listed in 2025 for donanemab, we're closely watching the preclinical Alzheimer's disease study, TRAILBLAZER ALZ-3.

談到神經退化性疾病，雖然我們沒有列出 2025 年 donanemab 的關鍵事件，但我們正在密切關注臨床前阿茲海默症研究 TRAILBLAZER ALZ-3。

This trial screened patients with a blood-based diagnostic and utilized a fixed duration of treatment with donanemab.

該試驗透過血液診斷篩檢患者，並採用固定療程的 donanemab 治療。

By moving earlier in disease progression, the goal is to reduce the risks of developing any symptoms of Alzheimer's disease.

透過儘早治療疾病，我們的目標是降低阿茲海默症任何症狀的風險。

While the current primary completion is projected for 2027, the study will read out when the target number of progression events are accrued.

雖然目前的小學教育預計在 2027 年完成，但研究將讀出目標進展事件數量的累積時間。

The new focus area for us in 2025 will be to study potential new applications of incretin biology across diseases in neuroscience and immunology.

2025 年我們的新重點領域將是研究腸促胰島素生物學在神經科學和免疫學疾病領域的潛在新應用。

With a pipeline of incretins in clinical development and deep scientific expertise in this space, Lilly is well positioned to match the biologic properties of specific molecules to the desired indications being studied.

憑藉臨床開發中的一系列腸促胰島素以及該領域的深厚科學專業知識，禮來公司能夠將特定分子的生物學特性與正在研究的所需適應症相匹配。

We plan to start several clinical trials assessing potential benefits of our incretins in areas that could include brain health, substance use disorder, pain, neuropsychiatry, and inflammation.

我們計劃啟動多項臨床試驗，評估腸促胰島素在腦部健康、物質使用障礙、疼痛、神經精神病學和發炎等領域的潛在益處。

We'll be prepared to move rapidly into Phase 3 trials based on clinical data and where our conviction is high.

我們將根據臨床數據和高度信心，做好迅速進入第三階段試驗的準備。

Lastly, we expect a number of important regulatory submissions in 2025, including orforglipron for obesity, as I detailed, insulin efsitora alfa for type 2 diabetes, tirzepatide for cardiovascular outcomes, and multiple potential data sets for Jaypirca. 2025 will be another exciting year for Lilly R&D.

最後，我們預計 2025 年將有許多重要的監管提交，包括用於治療肥胖症的 orforglipron（如我所詳述）、用於治療 2 型糖尿病的胰島素 efsitora alfa、用於治療心血管疾病的 tirzepatide 以及 Jaypirca 的多個潛在數據集。 2025 年對於禮來研發來說將會是另一個令人興奮的一年。

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

現在，我將把電話轉回給戴夫，請他做一些結束語。

Yeah.

是的。

Thanks, Dan.

謝謝，丹。

So we had a strong financial performance in Q4 and throughout 2024.

因此，我們在第四季和整個 2024 年都擁有強勁的財務表現。

We finished $4 billion above our first-time revenue guide and $4 per share above our first-time EPS guide when taking IPR&D or charges into account.

如果將智慧財產權與研發 (IPR&D) 或費用考慮在內，我們的最終營收將比首次預期高出 40 億美元，每股盈餘將比首次預期高出 4 美元。

The incretin market continues to grow rapidly, and Mounjaro and Zepbound are both gaining share of market.

腸促胰島素市場持續快速成長，Mounjaro 和 Zepbound 的市佔率都在增加。

We believe both products are still very early in their launch cycle.

我們相信這兩款產品的發布週期仍處於早期階段。

In addition, our oncology, immunology, and neuroscience therapeutic areas continue to progress, launching new medicines and delivering strong revenue growth.

此外，我們的腫瘤學、免疫學和神經科學治療領域不斷取得進展，推出新藥並實現強勁的收入成長。

We have an exciting outlook for growth in 2025 as well.

我們對 2025 年的成長前景也非常樂觀。

New indications, new manufacturing capacities, new access opportunities, and new markets are all tailwinds to our financial performance.

新的適應症、新的製造能力、新的進入機會和新的市場都是我們財務表現的順風。

We made significant advances across our pipeline in 2024 and have several exciting readouts, which Dan just highlighted, expected throughout 2025.

我們在 2024 年在整個管道方面取得了重大進展，並有幾份令人興奮的讀數，正如 Dan 剛才強調的那樣，預計將在 2025 年完成。

So now, let me turn the call over to Mike to moderate our Q&A session.

現在，讓我將電話轉給麥克來主持我們的問答環節。

Thanks, Dave.

謝謝，戴夫。

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

我們希望回答盡可能多的來電者的問題並準時結束通話。

So to that end, consistent with prior quarters, we will respond to one question per caller and we will end at 11:00 AM.

因此，與前幾季一樣，我們將只回答每個來電者的單一問題，並於上午 11:00 結束討論。

If you have more than one question, you may re-enter the queue, and we will get to your question if time allows.

如果您有多個問題，您可以重新進入佇列，如果時間允許，我們會回答您的問題。

Paul, please provide the instructions for the Q&A, and we're ready to take the first caller.

保羅，請提供問答環節的說明，我們準備接聽第一位來電。

(Operator Instructions) Tim Anderson, Bank of America.

（操作員指示）美國銀行蒂姆·安德森。

Thanks so much.

非常感謝。

Just a question on the guidance -- the 2025 guidance.

我只是想問一下有關 2025 年指導意見的問題。

So I think everyone knows the prescription uptake trend didn't show acceleration, hasn't shown it yet.

所以我想大家都知道處方藥的使用趨勢並沒有加速，還沒有顯現出來。

That's been viewed by some as a concern.

有些人認為這是一個值得擔憂的問題。

Does the 2025 guidance require acceleration?

2025 年指導方針是否需要加速？

Or can you get their scripts just to continue on the same trajectory and the slope of that line doesn't change?

或者你能讓他們的腳本繼續沿著相同的軌跡運行，而該線的斜率不會改變嗎？

When I do back-of-the-envelope math, it seems like that's frankly all that needs to occur.

當我進行粗略計算時，似乎這就是所需要發生的一切。

And one of your slides suggests that might be the right way to think about it as well.

您的一張投影片也顯示這也許是正確的思考方式。

But can you just confirm?

但你能確認一下嗎？

Great.

偉大的。

Thanks, Tim, for the question.

謝謝蒂姆提出這個問題。

We'll go to Lucas to talk about the guidance assumptions.

我們將去找盧卡斯討論指導假設。

Yeah.

是的。

We mentioned in my notes that what we expect to see, Tim, is a continuation of basically the total prescription growth that we have seen in 2024.

我們在我的筆記中提到，提姆，我們預計看到的是 2024 年總處方量成長的延續。

So that's what we built in our 2025 guide for the market.

這就是我們為 2025 年市場制定的指南。

Great.

偉大的。

Next question, please.

請回答下一個問題。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林 (Terence Flynn)。

Great.

偉大的。

Thanks so much.

非常感謝。

I was just wondering if you could maybe elaborate on your expectations for Zepbound payer dynamics and access this year, particularly the impact from the OSA label -- I know you've also filed for heart failure -- and how you expect that to play out over the course of the year.

我只是想知道您是否可以詳細說明您對今年 Zepbound 付款人動態和訪問的期望，特別是 OSA 標籤的影響 - 我知道您也申請了心臟衰竭 - 以及您預計這將如何在今年發揮作用。

And then anything on next steps on the compounding litigation that we should be focused on?

那麼，我們應該關注複合訴訟的下一步嗎？

Thank you.

謝謝。

Dangerously close to a two-part question there, Terence.

特倫斯，這個問題危險地接近由兩部分組成的問題。

But we'll go to Patrik to talk about access, and then I'll come back to Dave to make a quick comment about compounding.

但我們會去找帕特里克討論訪問權問題，然後我會回到戴夫那裡對複合問題做一個簡短的評論。

Thank you very much.

非常感謝。

When we look at the commercial access, it remains strong.

當我們觀察商業通道時，它依然強勁。

We have 87% coverage in the commercial space still, and of course, the employer opt-in is a second step of high importance.

我們在商業領域的覆蓋率仍然有 87%，當然，雇主的選擇是第二步，非常重要。

That made progress in 2024, and we expect in terms of employer opt-in that we're north of 50% today.

這在 2024 年取得了進展，我們預計，就雇主選擇率而言，目前這一比例將超過 50%。

OSA remains an opportunity for us to gain access also in the Medicare segment, and CMS confirmed recently that they will reimburse OSA if Plan B plans decides to lift it.

OSA 仍然是我們進入醫療保險領域的機會，CMS 最近確認，如果 B 計劃決定取消 OSA，他們將償還 OSA。

They have 180 days to make that decision from the FDA approval, and we're working with plans right now and we anticipate to get some Medicare coverage by the second half of this year.

從 FDA 批准之日起，他們有 180 天的時間來做出決定，我們目前正在製定計劃，預計今年下半年將獲得一些醫療保險覆蓋。

And similarly, OSA is also an opportunity for us to get more Medicaid states signed in.

同樣，OSA 也為我們提供了一個讓更多醫療補助州簽署的機會。

We expect PF, when and if approved, to have a similar role as OSA and access opportunity, particularly in Medicare and Medicaid.

我們期望，一旦獲得批准，PF 能夠發揮與 OSA 類似的作用並提供獲取機會，特別是在醫療保險和醫療補助領域。

Yeah.

是的。

So regarding compounding, I think our position's been pretty clear.

因此，關於複利，我認為我們的立場已經非常明確了。

We've been in supply since August, and the FDA took us off the list formally.

我們自八月起就開始供貨，FDA 已正式將我們從名單上除名。

Later in Q4, of course, the compounding associations are suing to delay that.

當然，在第四季後期，複合協會將提起訴訟以推遲這一進程。

We oppose that.

我們反對這種做法。

I'm enjoying that suit.

我很喜歡那套西裝。

I think the next date coming up is February 18, where the FDA said that's when you need to stop one form of compounding.

我認為下一個日期是 2 月 18 日，FDA 表示屆時你需要停止一種複合形式。

Our position's been clear all along.

我們的立場始終很明確。

We don't think there's a place for this because we have full supply and there's no reason to have a non-approved kind of illegitimate product out there.

我們認為不應該出現這種情況，因為我們有充足的供應，沒有理由在市場上銷售未經批准的非法產品。

So of course, new sheriff in town, new government, and court case pending, so we don't know the outcome of all that.

當然，城裡有新警長、新政府、還有懸而未決的案件，所以我們不知道這一切的結果。

But that all said, I mean, I think our business is growing nicely in Q4, and we can see that prescription trends early this year.

但總而言之，我認為我們的業務在第四季度成長良好，而且我們可以在今年年初看到處方趨勢。

It's just an unsafe practice that shouldn't exist and, long term, probably isn't great for innovators, so we'd like to move on from this and hope that's what the courts and the government decide to do.

這是一種不安全的做法，不應該存在，從長遠來看，可能對創新者不利，所以我們希望擺脫這種狀況，並希望法院和政府決定這麼做。

Great.

偉大的。

Thanks, David and Patrik.

謝謝，大衛和派崔克。

Next caller, please.

請下一位來電。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

Hi, everyone.

大家好。

Thanks for taking the call today.

感謝您今天接聽電話。

I just wanted to zoom into orforglipron specifically, and I think you took the chance to make the point about diabetes and diabetes population and their weight loss.

我只是想具體地介紹一下 orforglipron，我認為您藉此機會闡述了有關糖尿病、糖尿病人群及其體重減輕的觀點。

Can you just talk a little bit more about kind of the potential positioning, particularly in the context of kind of that single injectable GLP-1 kind of anticipated efficacy that you were guiding to?

您能否再多談談潛在的定位，特別是針對您所指導的單次注射 GLP-1 預期功效的背景下？

Great.

偉大的。

Thanks, Courtney.

謝謝，考特尼。

We'll go to Dan to talk about the right comp for orforglipron.

我們將和丹討論 orforglipron 的正確替換。

Yeah, sure.

是的，當然。

I'll start on the efficacy expectations, and then maybe Patrik can talk about the market positioning here.

我將從功效預期開始，然後帕特里克可以談談這裡的市場定位。

So you're right.

所以你是對的。

It's a single GLP-1, and we take pains to mention that because we're not expecting the kinds of efficacy or tolerability actually that we see with tirzepatide, which is a dual-acting agent.

它是一種單一的 GLP-1，我們之所以要費力提及這一點，是因為我們實際上並沒有期待它具有與 tirzepatide（一種雙重作用的藥物）一樣的功效或耐受性。

Still, as you know, monotherapy with GLP-1 has provided important benefits to many patients, and so we're setting our sights there.

不過，如您所知，GLP-1 單一療法為許多患者帶來了重要益處，因此我們將目光投向了此。

This is a first study in type 2 diabetes patients where, as I noted, weight loss is typically quite a bit lower than you see in people without type 2 diabetes.

這是一項針對 2 型糖尿病患者的首次研究，正如我所指出的，體重減輕通常比非 2 型糖尿病患者的體重減輕要低得多。

So we sort of index on the efficacy that we've seen in the past with ozempic, and we'll get that data soon and excited to see it.

因此，我們根據過去使用 ozempic 所見的功效進行分類，我們很快就會得到該數據，並且很高興看到它。

Patrik?

派崔克？

And from a positioning perspective, we like the idea of having an oral with an injectable GLP-1-like efficacy, and there is a big portion of patients that actually have needle fear -- it's estimated in the US to be 20% to 25% -- and also a group of patients that doesn't necessarily need the amount of weight loss or HbA1c reduction as tirzepatide generates.

從定位角度來看，我們喜歡口服藥物具有與注射 GLP-1 類似功效的想法，而且有很大一部分患者實際上有針頭恐懼症——在美國估計這一比例為 20% 至 25%——而且還有一部分患者不一定需要像 tirzepatide 那樣減輕體重或降低 HbA1c。

So that might be an opportunity in the maintenance space as well.

所以這也可能是維護領域的一個機會。

But last, and very importantly, it's an opportunity to scale in markets outside the US taking into account that we don't have a need for refrigeration.

最後，也是非常重要的一點，這是一個在美國以外市場擴大規模的機會，因為我們不需要冷藏。

Great.

偉大的。

Thanks, Patrik and Dan.

謝謝，派崔克和丹。

Next caller, please.

請下一位來電。

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特 (Chris Schott)。

Great.

偉大的。

Thanks so much.

非常感謝。

Just another orforglipron question.

這只是另一個 orforglipron 問題。

You've now launched a pretty wide range of studies, I guess to say hypertension, beyond the initial obesity and type 2 diabetes studies.

現在，您已經開展了相當廣泛的研究，我想應該是關於高血壓的研究，而不僅僅是最初的肥胖症和 2 型糖尿病的研究。

Can you just elaborate a little bit more on what gives you confidence in running such a wide range of programs without having seen those initial readouts, particularly maybe some of the tolerability profiles with the drugs titration, et cetera?

您能否進一步詳細說明一下，為什麼您在沒有看到那些初始讀數的情況下，有信心運行如此廣泛的程序，特別是一些藥物滴定的耐受性概況等等？

I'm just trying to think of how you balance kind of the risk taking there with the confidence in the asset you have right now.

我只是想知道如何平衡所承擔的風險和對你目前所擁有的資產的信心。

Thank you.

謝謝。

Great.

偉大的。

Thanks, Chris.

謝謝，克里斯。

We'll go to Dan for that question.

我們將請丹來回答這個問題。

Yeah.

是的。

Thanks, Chris.

謝謝，克里斯。

It's a smart question.

這是一個聰明的問題。

Of course, going into Phase 3 with any drug, particularly a small molecule such as orforglipron, the biggest risk is safety.

當然，任何藥物，特別是像奧格列丙這樣的小分子藥物，進入第 3 階段，最大的風險就是安全性。

And I think as these trials proceed, even though we're not seeing the safety data, we'll grow more confident in the overall safety profile of the drug because trials continue uninterrupted.

我認為隨著這些試驗的進行，即使我們沒有看到安全數據，我們也會對該藥物的整體安全性更加有信心，因為試驗將不間斷地繼續進行。

Of course, we won't know for sure until we get that first data readout and then subsequent data readouts, but it's correct that we grow more and more confident in the success of this molecule as each day passes.

當然，在我們獲得第一個數據讀數和隨後的數據讀數之前，我們無法確切知道，但隨著時間的推移，我們對這種分子的成功越來越有信心。

As for specifics around tolerability and titration and discontinuation, those don't really factor into our thinking.

至於耐受性、滴定和停藥的具體細節，這些其實並沒有考慮到我們的考慮。

We haven't had a look at unblinded data for any of those things, so we can't make assumptions on that yet.

我們還沒有查看過任何這些事項的非盲數據，因此我們還不能對此做出假設。

Great.

偉大的。

Thanks, Dan.

謝謝，丹。

Next question, please.

請回答下一個問題。

Geoff Meacham, Citibank.

花旗銀行的傑夫‧米查姆。

Hey, guys.

嘿，大家好。

Thanks for taking the question.

感謝您回答這個問題。

Just had one on commercial tirzepatide in bigger settings like diabetes prevention or if the SURPASS-CVOT is successful, would this be a tipping point on broader reimbursement or access?

剛剛在糖尿病預防等更大的環境中進行了一項關於商業化替澤帕肽的研究，或者如果 SURPASS-CVOT 成功，這是否會成為更廣泛報銷或獲取的轉折點？

I mean, it's clear you have a benefit there, but I wasn't sure if commercial payers of Medicare are looking for yet even more data to support kind of risk benefit.

我的意思是，很明顯你有好處，但我不確定醫療保險的商業支付者是否正在尋找更多的數據來支持這種風險收益。

Thank you.

謝謝。

Great.

偉大的。

Thanks, Geoff.

謝謝，傑夫。

We'll go to Patrik to talk about the broader landscape there.

我們將去找帕特里克談論那裡更廣闊的景觀。

Thank you very much, Geoff.

非常感謝，傑夫。

I think one extension is definitely defined as game-changing at the provider level, and we are in discussions, of course, with regulatory agencies, but there is no precedent for a type 2 prevention as an indication.

我認為一次擴展肯定會在提供者層面改變遊戲規則，當然，我們正在與監管機構進行討論，但是沒有以 2 型預防作為指徵的先例。

But the data itself, I think we will utilize to really drive increased employer opt-in, seeing the benefits of outcomes studies and treatment of people with pre-diabetes and obesity.

但我認為我們將利用數據本身來真正推動更多雇主選擇，看到結果研究和對糖尿病前期和肥胖症患者的治療的好處。

Maybe just a broader point, which we've said before, Geoff.

也許只是一個更廣泛的觀點，我們之前已經說過了，傑夫。

I think a lot of investors are looking for some single event that will trigger the broader reimbursement or not.

我認為很多投資者都在尋找某個能夠或不會觸發更廣泛報銷的單一事件。

I don't think we've ever really thought of it that way, but rather an accumulation and sort of weight of everything that will grow reimbursement steadily over time.

我認為我們從來沒有真正這樣想過，而是所有事物的累積和重量都會隨著時間的推移而穩步增加報銷金額。

And I think that's actually what we've seen since we launched Zepbound last year, US commercial insurance picking up several points during the year; and even ex-US now, we have UK reimbursement, et cetera.

我認為這正是我們自去年推出 Zepbound 以來所看到的情況，美國商業保險在年內上升了幾個點；甚至現在在美國以外，我們也可以獲得英國的報銷等等。

But different payers will make decisions at different times.

但不同的付款人會在不同的時間做出決定。

And I think the data sets you've mentioned will be some of the more compelling great moves, but still then the way affordability and budget constraints, et cetera.

我認為您提到的數據集將是一些更引人注目的重大舉措，但仍然存在可負擔性和預算限制等問題。

That all said, by the time we get to the end of the decade, it's hard to imagine we are not using obesity medications to prevent what is the precursor condition to so many chronic diseases.

儘管如此，到本世紀末，很難想像我們不會使用肥胖藥物來預防許多慢性病的前兆。

And already, the health economics are pretty compelling, and there will be more data coming beyond that.

目前，衛生經濟學已經相當引人注目，而且還會有更多的數據湧現。

So long term, we remain really bullish on this whole category being reimbursed like we expect to reimburse all other medications.

因此，從長遠來看，我們仍然非常看好整個類別的藥物能夠獲得報銷，就像我們預期報銷所有其他藥物一樣。

Just the schedule for that is going to be more slow and steady, I would say, as you model expectations on a global scale and in the US as well because of the diversity of payers.

我想說，由於付款人的多樣性，你需要在全球範圍內以及在美國模擬預期，因此這個計劃將會更加緩慢而穩定。

Great.

偉大的。

Thanks, Dave and Patrik.

謝謝，戴夫和派崔克。

Next question, please.

請回答下一個問題。

Seamus Fernandez, Guggenheim Securities.

古根漢證券公司的謝默斯‧費爾南德斯 (Seamus Fernandez)。

Hi, this is Colleen on for Seamus.

大家好，我是 Colleen，為 Seamus 主持。

Thanks for taking our question.

感謝您回答我們的問題。

We just wanted to ask on the sustainability of operating margin expansions.

我們只是想問一下營業利潤率擴張的可持續性。

Looking at some of the longer-term forecasting from sell-side consensus, we're seeing estimates nearing 50% by the end of the decade.

從賣方共識來看，一些長期預測顯示，到本世紀末這一數字將接近 50%。

Do you view this as realistic?

您認為這現實嗎？

Or how are you thinking about the balance between the margins and then also ensuring you're not [under-investigating] on the pipeline?

或者您如何考慮利潤之間的平衡，然後確保您不會對管道進行[調查不足]？

Great.

偉大的。

Thanks for the question, Colleen.

謝謝你的提問，科琳。

I'll go to Lucas to talk about the long-term operating margin philosophy.

我將與盧卡斯討論長期營業利潤率理念。

Well, we are very pleased with the results that we've seen in 2024 and Q4, and we provided a guidance for 2025 that is a continuation of that margin expansion.

嗯，我們對 2024 年和第四季度的結果非常滿意，我們為 2025 年提供了指導，這是利潤率擴大的延續。

I mentioned 340 basis points expansion in 2025.

我曾提過 2025 年擴張 340 個基點。

Thinking more long term, our view is how we continue to drive growth in a sustainable manner.

從更長遠的角度考慮，我們的觀點是如何繼續以可持續的方式推動成長。

And in order to do so, we believe that reinvesting into the business, in particular in R&D, to drive that innovation and growth into the future is a critical success factor for our business.

為了實現這一目標，我們相信對業務進行再投資，特別是對研發進行再投資，以推動未來的創新和成長，是我們業務成功的關鍵因素。

So from that perspective, we mentioned before that we believe that getting into high 40s% or 50% is not actually a good way to drive that sustainable growth into the future.

因此從這個角度來看，我們之前提到過，我們認為達到 40% 或 50% 實際上並不是推動未來永續成長的好方法。

So what we are seeing now on that low 40s% is, in particular at this time, the right basically balance that we have in terms of investment into the business and also the returns that we generate as well.

因此，我們現在看到的 40% 以下的回報率，特別是在目前這個水平，基本上是我們在業務投資和產生的回報方面的正確平衡。

Great.

偉大的。

Thanks, Lucas.

謝謝，盧卡斯。

Next question, please.

請回答下一個問題。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

Hi there.

你好呀。

This is Conor MacKay on for Evan.

這是 Conor MacKay，代替 Evan。

Thanks for taking our question.

感謝您回答我們的問題。

Given some of the slower launches we've seen from peers in the Alzheimer's space, can you maybe talk a bit about the lessons you've taken from those, and then as well as sort of your experience early days in the Kisunla launch?

鑑於我們看到阿茲海默症領域的一些同行的發布速度較慢，您能否談談您從中吸取的教訓，以及您在 Kisunla 發布初期的經驗？

Thank you.

謝謝。

Great.

偉大的。

Thanks, Conor, for the question.

謝謝康納提出這個問題。

We'll go to Anne to talk about Kisunla.

我們將去找安妮談論基蘇拉 (Kisunla)。

Well, thanks so much for the question about Kisunla.

好吧，非常感謝您提出有關 Kisunla 的問題。

And I'll tell you, we are pleased with our momentum so far.

我可以告訴你們，我們對迄今為止的發展勢頭感到滿意。

What our team is focused on really is system readiness and growth.

我們的團隊真正關注的是系統準備和發展。

That's still a significant area of opportunity in this space.

這仍然是該領域的重大機會。

So we're partnering with healthcare providers to scale and reach more patients.

因此，我們正在與醫療保健提供者合作，以擴大規模並惠及更多患者。

As far as how it's going so far, Lucas mentioned key indicators that we're watching.

至於目前的進展情況，盧卡斯提到了我們正在關注的關鍵指標。

To date, we've achieved P&T approvals of over 80% in our key accounts.

到目前為止，我們主要客戶的 P&T 批准率已超過 80%。

We have over 800 prescribers.

我們有超過 800 位處方人員。

And then an important leading indicator is the diagnostics front.

然後一個重要的領先指標是診斷前沿。

And those results also continue to be encouraging. [Ambivid] use is more than doubling in the last year, and the use of blood diagnostics grows significantly each month as well.

這些成果也持續令人鼓舞。 [Ambivid] 的使用量在去年增加了一倍多，而且血液診斷的使用量每月也在大幅增加。

The true challenge here is the healthcare system's readiness and, I think, most critically, the capacity to detect and diagnose patients.

這裡真正的挑戰是醫療保健系統的準備情況，以及我認為最關鍵的是檢測和診斷患者的能力。

And so we have a number of solutions that we're working on with the healthcare providers to help them increase that capacity, increase the throughput for patients, a lot of educational series as well on how to quickly diagnose and treat these patients.

因此，我們正在與醫療保健提供者合作制定多種解決方案，幫助他們提高治療能力，增加患者的吞吐量，同時也提供了許多關於如何快速診斷和治療這些患者的教育系列。

Importantly, I think we're hearing a lot of enthusiasm about the profile of Kisunla, and that actually helps with these capacity constraints.

重要的是，我認為我們聽到了很多關於 Kisunla 的熱情評價，這實際上有助於緩解這些容量限制。

The once-monthly infusions, the ability to stop dosing once blast cleared, all of those positions have told us are going to help with some of these capacity constraints.

每月一次的輸液、一旦消除爆炸就可以停止給藥的能力，所有這些立場都告訴我們，這將有助於解決一些容量限制問題。

So it's been a strong start so far.

到目前為止，這是一個好的開始。

We definitely learned lessons from the first launch that went out there and applying that learning to what we're doing now.

我們確實從第一次發布中吸取了教訓，並將這些經驗運用到我們現在所做的事情中。

But it's been really positive so far in the terms of the level of support and collaboration that Lilly's been able to bring with our expertise in the field and our long relationships with these customers.

但到目前為止，禮來憑藉我們在該領域的專業知識以及與這些客戶的長期關係所提供的支持和合作水平確實非常積極。

Great.

偉大的。

Thanks, Anne.

謝謝，安妮。

Next question, please.

請回答下一個問題。

Umer Raffat, Evercore.

烏默·拉法特（Umer Raffat），Evercore。

Hi, guys.

嗨，大家好。

Thanks for taking my question.

感謝您回答我的問題。

It's certainly very encouraging to see the range of new Phase 3 trials being initiated with orforglipron in the past few months.

看到過去幾個月中 Orforglipron 啟動的一系列新階段 3 期試驗確實非常令人鼓舞。

But there's one trial in particular I noticed has not been initiated or may not be in the plans, which is an outcomes trial.

但我注意到有一項試驗尚未啟動或可能不在計劃中，即結果試驗。

I'm just curious what's the thought process behind that?

我只是好奇這背後的想法是什麼？

Thank you.

謝謝。

Great.

偉大的。

Thanks, Umer, for the question.

謝謝 Umer 提出這個問題。

We'll go to Dan to talk about the orfor development plan.

我們將和丹討論 ORFor 發展計劃。

Yeah.

是的。

Thanks, Umer.

謝謝，烏默爾。

Of course, we're trying to cover a broad landscape of indications here that we think would be important and fit with the advantages an oral medication has, so sort of primary care, broad use kinds of applications being prioritized.

當然，我們試圖在這裡涵蓋我們認為重要且符合口服藥物優勢的廣泛適應症，因此優先考慮初級保健和廣泛使用的應用。

Outcomes studying is an interesting idea.

結果研究是一個有趣的想法。

The challenges here in maintaining patients on placebo make it more and more difficult to do those kinds of studies in the US.

維持患者服用安慰劑的挑戰使得在美國進行此類研究變得越來越困難。

But it's certainly an idea that we're exploring around the world and have more thinking to come in the future.

但這確實是我們正在世界各地探索的想法，未來還會有更多的思考。

Great.

偉大的。

Thank you, Dan.

謝謝你，丹。

Next question, please.

請回答下一個問題。

Steve Scala, TD Cowen.

史蒂夫·斯卡拉（TD Cowen）。

Well, thank you so much.

好吧，非常感謝。

I apologize in advance for this question.

我提前為這個問題道歉。

But over the past six to nine months, there has been a consistent cadence of data points questioning the size of the addressable and accessible obesity market, none of which are news, but include: slowing prescription trends, Lilly meeting demand at least a year early, Lilly instituting DTC and extending co-pay cards despite struggling to meet demand, Lilly launching in OUS markets despite struggling to meet US demand, and significant stocking fluctuations and challenges in guiding.

但在過去六到九個月裡，不斷有數據點對可尋址和可訪問的肥胖症市場的規模提出質疑，這些數據都不是新聞，但包括：處方趨勢放緩、禮來至少提前一年滿足需求、禮來在難以滿足需求的情況下設立 DTC 並延長共同支付卡服務、禮來在難以滿足美國需求的情況下進軍美國的情況下進軍

Taken collectively, these points are concerning.

綜合來看，這些觀點令人擔憂。

I think you will say that they all relate to the unprecedented size of the market and meeting its demand.

我想你會說，它們都與前所未有的市場規模及其需求有關。

But can you state that there has not been any conversations within Lilly questioning whether we are all significantly over our skis on this market and that the manufacturing buildout may simply be too aggressive?

但是，你能否說，禮來公司內部從未進行過任何討論，質疑我們是否已經完全超越了這個市場，以及生產擴張是否過於激進？

Thank you.

謝謝。

Great.

偉大的。

Well, Steve, thanks for the apology and the question.

好吧，史蒂夫，謝謝你的道歉和提問。

I'll go to Dave for that one.

我要去找戴夫。

Yeah.

是的。

Steve, I think you've been calling into our calls for most of my career.

史蒂夫，我想在我職業生涯的大部分時間裡你都在與我們通話。

I've never had the apology up front, so I appreciate that.

我從來沒有收到過這樣的道歉，所以我很感激。

I know why you're asking it.

我知道你為什麼要問這個問題。

And I think the perspective that we have is that it's early days on a very, very large opportunity.

我認為，我們的觀點是，這是一個非常巨大的機遇，目前還處於早期階段。

There's turbulence; I'll own that.

有湍流；我會擁有它。

We always seek to put projections out that we can hit with confidence, but that are also within the range of possibilities.

我們始終致力於提出有信心實現的預測，但也是在可能性範圍內。

And in the back half of that year -- last year, we fell short of that.

但在去年下半年，我們未能實現這個目標。

But everything we've said is true, and we continue to believe it -- that this is a market with hundreds of millions of people globally, that there is a unique thing here in that we can both prevent a large portion of chronic disease with obesity drugs.

但我們所說的一切都是真的，我們也將繼續堅信這一點——這是一個擁有全球數億人口的市場，這裡的獨特之處在於，我們既可以利用肥胖藥物來預防大部分慢性疾病。

And last year, we saw proof points on that from Lilly and our competitor, that it's not just weight loss, it translates into chronic disease outcomes.

去年，我們從禮來公司和我們的競爭對手那裡看到了這方面的證據，證明這不僅僅是減肥，還可以治療慢性疾病。

You'll hear and see more of that.

您將會聽到並看到更多這樣的內容。

And people love taking these drugs.

人們喜歡服用這些藥物。

We know that because when we run out, which we did last year, they get very angry with us.

我們之所以知道這一點，是因為當我們的庫存用完時（去年我們就庫存用完了），他們會對我們非常生氣。

And so I have been a person who represents to the Board of the CapEx decisions.

因此，我一直是向董事會代表資本支出決策的人。

I have zero doubt that we have still more building to do and that the capacity we've put in the ground so far is not sufficient to meet global demand.

我毫不懷疑，我們還有更多的建設工作要做，而且我們迄今為止投入的產能不足以滿足全球需求。

You'll hear more about that from us.

您將會從我們這裡了解到更多相關資訊。

Of course, as highlighted on this call, we're getting close to, I think, a relief valve on that, which is the idea that you can have an oral, which is scalable in a way that injectable systems just aren't, really test the question legitimately, what is the edge of the demand curve?

當然，正如在這次電話會議中所強調的那樣，我認為，我們正接近解決這個問題的減壓閥，即你可以擁有一種口服藥物，它具有可擴展性，而注射系統則無法做到這一點，這真正合法地檢驗了這個問題：需求曲線的邊緣是什麼？

But we don't think we're close to it right now.

但我們認為現在我們還沒有接近這個目標。

We're still gating promotion and gating launches globally.

我們仍在全球範圍內進行推廣和發布。

That's a different thing.

那是另一回事。

And we're building facilities as fast as we can to match up those two things, what we can make and what we can sell.

我們正在盡快建造設施，以滿足這兩點要求：我們能生產什麼以及我們能銷售什麼。

And although we're supplying the US market well right now, we'll need to do more.

儘管我們目前對美國市場的供應很好，但我們還需做得更多。

And I'm pretty confident in that.

我對此非常有信心。

So hopefully, that gives you some color on the mindset here and wouldn't overread the turbulence and prediction challenges we have.

所以希望，這能讓您對這裡的思維方式有所了解，並且不會過度解讀我們所面臨的湍流和預測挑戰。

But long term, we're very bullish and you'll see us act according to that belief.

但從長遠來看，我們非常樂觀，你會看到我們按照這種信念行事。

Thank you, Dave.

謝謝你，戴夫。

Next question, please.

請回答下一個問題。

Mohit Bansal, Wells Fargo.

富國銀行的莫希特·班薩爾 (Mohit Bansal)。

Great.

偉大的。

Thank you very much for taking my question.

非常感謝您回答我的問題。

And I have a question regarding sleep apnea.

我有一個關於睡眠呼吸中止症的問題。

Now that you have sleep apnea on label, how have the discussions with the prescribers, as well as payers, have gone so far?

既然藥品標籤上已經註明可以治療睡眠呼吸暫停，那麼與處方人員以及付款人的討論進展如何？

The one pushback we hear is that these patients are often treated by sleep specialists, and there's a general shortage of those specialists here.

我們聽到的一個反對意見是，這些病人通常由睡眠專家治療，但這裡普遍缺乏這樣的專家。

So could you talk a little bit about the call points and then how you're thinking about this?

那麼您能否稍微談談呼叫點以及您對此的看法？

Great.

偉大的。

Thanks, Mohit.

謝謝，Mohit。

We'll go to Patrik for the question on sleep apnea, what the discussions are like with some of the prescribers, and the initial experience so far.

我們將向派崔克詢問有關睡眠呼吸中止症的問題，與一些處方人員的討論情況以及迄今為止的初步經驗。

Thank you very much, Mohit.

非常感謝，Mohit。

Yes, you're correct.

是的，你說得對。

It's the first pharmacological treatment ever approved for obstructive sleep apnea.

這是迄今為止首個獲準用於治療阻塞性睡眠呼吸中止症的藥物。

So there is a lot of lifting on our side, and we will approach that as we are approaching any new disease area, partnering with advocacy organizations, healthcare providers, and massive, massive efforts in terms of medical education.

因此，我們還有很多工作要做，我們會像對待任何新的疾病領域一樣對待這些工作，與倡導組織、醫療保健提供者合作，並在醫學教育方面付出巨大的努力。

We expect this to go beyond the sleep specialist, but of course, we are starting our efforts with the sleep specialist community, and I think that's been very well received so far.

我們希望這項活動能超越睡眠專家的範疇，但當然，我們的努力是從睡眠專家社群開始的，我認為到目前為止，我們的努力已經得到了廣泛的反響。

And we are meeting with them regularly, conducting speaker's trainings, but with the aim to move to primary care, which is a necessity, because this is also a patient population that, to a large extent, remains undiagnosed.

我們定期與他們會面，進行演講者培訓，但目標是轉向初級保健，這是必要的，因為這也是很大程度上未被診斷的患者群體。

So primary care is also going to be required.

因此，也需要初級護理。

Great.

偉大的。

Thank you, Patrik.

謝謝你，派崔克。

Next caller, please.

請下一位來電。

Dave Risinger, Leerink Partners.

Dave Risinger，Leerink Partners。

Thanks very much.

非常感謝。

So my incretin-related questions have been asked.

因此，有人詢問了我的與腸促胰島素相關的問題。

I wanted to just pivot to the long-acting relaxin candidate, volenrelaxin.

我只是想轉向長效鬆弛素候選藥物 volenrelaxin。

And so the company had advanced it into a CKD trial in the fourth quarter, but then recently canceled both the heart failure and CKD programs.

因此，該公司在第四季度將其推進到 CKD 試驗，但最近取消了心臟衰竭和 CKD 計畫。

Dan, I'm hoping you could provide some more color on what drove the action, plus how you now view the long-acting relaxin mechanism, including potential for future development in other cardiopulmonary diseases.

丹，我希望你能更詳細地說明採取這項行動的原因，以及你現在如何看待長效鬆弛素機制，包括未來在其他心肺疾病中發展的潛力。

Thanks very much.

非常感謝。

Great.

偉大的。

Thanks, Dave.

謝謝，戴夫。

We'll go to Dan to talk about the volenrelaxin program.

我們將去找丹討論 volenrelaxin 計劃。

Thank you.

謝謝。

I was disappointed with the results from the Phase 2 trial, for sure.

我確實對第二階段試驗的結果感到失望。

Relaxin is an interesting mechanism, I think, sort of validated by normal human physiology during pregnancy.

我認為鬆弛素是一種有趣的機制，在某種程度上已被懷孕期間正常的人體生理所證實。

But unfortunately, the results that we got in this trial didn't support proceeding with this molecule.

但不幸的是，我們在這次試驗中得到的結果並不支持繼續使用這種分子。

I read that as speaking to the mechanism, rather than the molecule.

我認為這是針對機製而不是分子。

But I know others are pursuing this mechanism, and I wish them success where we didn't have it.

但我知道其他人也在推行這種機制，我希望他們能夠在我們沒有做到的地方取得成功。

So we'll have to wait and see.

因此我們只能拭目以待。

Thank you, Dan.

謝謝你，丹。

Next question, please.

請回答下一個問題。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞（Jefferies）。

Thanks so much.

非常感謝。

So at JPMorgan, your team mentioned you expect GLP-1 pricing to be relatively stable in 2025.

因此在摩根大通，您的團隊提到您預計 GLP-1 定價在 2025 年將相對穩定。

Are you implying that while you'll give additional discounts to the channel to improve access, that will be offset by improved adherence?

您是否暗示，雖然您會向頻道提供額外折扣以改善訪問量，但這會透過提高依從性來抵消？

Or is it more -- will these reach the steady state on discounts, at least until semaglutide gets put under IRA negotiation in 2026?

或更多——這些是否會達到折扣的穩定狀態，至少直到 2026 年 semaglutide 被納入 IRA 談判？

Thanks.

謝謝。

All right.

好的。

Thanks, Akash.

謝謝，阿卡什。

We'll go to Lucas to talk about GLP-1 pricing trends.

我們將採訪盧卡斯 (Lucas)，討論 GLP-1 定價趨勢。

Thanks for the question.

謝謝你的提問。

In terms of the pricing trends that I alluded to in the JPMorgan Conference and getting into 2025, first, we talk about the Q4.

關於我在摩根大通會議上提到的 2025 年定價趨勢，首先，我們討論的是第四季。

And into 2025, what we mentioned basically is a continuation of the trends.

而到了 2025 年，我們提到的基本上就是趨勢的延續。

Remember that we had in the base period in 2023 an uncovered co-pay that basically created quite a lot of noise on the year-on-year comparison.

請記住，在 2023 年的基準期內，我們有一個未涵蓋的共同支付，這基本上在同比比較中產生了相當大的噪音。

So we talk about basically adjusting by that.

因此我們討論的基本上就是以此來進行調整。

There's still single-digit erosion on our pricing trends.

我們的定價趨勢仍然有個位數的下降。

And that is the same trends that I alluded that will continue into 2025.

這就是我提到的趨勢，而這種趨勢將持續到 2025 年。

In terms of some of the dynamics on the access side, I don't know if you want to comment anything, Patrik, on your side.

關於訪問方面的一些動態，帕特里克，我不知道您是否想就此發表任何評論。

I think we have really good access on the Mounjaro side, over 90% in commercial and Part D, and I've already covered the commercial space for Zepbound.

我認為我們在 Mounjaro 一側擁有非常好的訪問權限，在商業和 D 部分中超過 90%，而且我已經為 Zepbound 覆蓋了商業空間。

We expect access to continue to improve in 2025 as well.

我們預計 2025 年的訪問情況將持續改善。

In terms of adherence, I think we just need to reflect on the dynamics that we have experienced in this market, partly due to supply constraints, but we are encouraged with what we see on Mounjaro.

在堅持方面，我認為我們只需要反思我們在這個市場所經歷的動態，部分原因是供應限制，但我們對 Mounjaro 所看到的感到鼓舞。

For patients that started in Q2 2023, we actually see a longer adherence with Mounjaro than we do both with Trulicity and ozempic.

對於從 2023 年第二季開始使用 Mounjaro 的患者，我們實際上發現其使用依從性比 Trulicity 和 ozempic 更長。

And as Dave referred to earlier, in terms of Zepbound, we expect adherence to be long here based upon the first-hand experiences that consumers have.

正如戴夫之前提到的，就 Zepbound 而言，根據消費者的第一手體驗，我們預計他們的堅持將會很長。

Great.

偉大的。

Thank you, Patrik.

謝謝你，派崔克。

Thank you, Lucas.

謝謝你，盧卡斯。

Next caller, please.

請下一位來電。

Alexandria Hammond, Wolfe Research.

亞歷山大‧哈蒙德，沃爾夫研究公司。

Thanks for taking the question.

感謝您回答這個問題。

With the Ro partnership, how does Lilly envision this relationship evolving?

透過與 Ro 的合作，禮來如何展望這段關係的發展？

And a follow-up, can you help frame the opportunity associated with Zepbound vials, and how is it expected to shift over time?

接下來，您能否協助描述與 Zepbound 小瓶相關的機遇，以及它預計會隨著時間的推移而發生怎樣的變化？

Great.

偉大的。

Thanks, Alex.

謝謝，亞歷克斯。

We'll go to Patrik to talk about Zepbound vials and Ro.

我們將和帕特里克討論 Zepbound 小瓶子和 Ro。

Yeah.

是的。

We launched the self-pay system with LillyDirect back in late August, and we are pleased with the performance so far.

我們在八月底與 LillyDirect 合作推出了自付費系統，我們對目前的表現感到滿意。

In terms of TRX for Zepbound, it's still low to mid-single digit.

就 Zepbound 的 TRX 而言，它仍然處於低到中等個位數。

But in terms of new therapy start, it's actually in the low T, so a very good start.

但就新療法的開始而言，它實際上處於低 T 狀態，因此是一個非常好的開始。

The partnership with Ro is not a financial or a marketing partnership at all.

與 Ro 的合作根本不是財務或行銷合作。

It's just the opportunity for eligible patients to have the option of using the Ro platform to purchase FDA-approved authentic medicines.

這只是為符合條件的患者提供使用 Ro 平台購買 FDA 批准的正品藥品的機會。

And it's really about connecting that software to LillyDirect self-pay pharmacy.

這實際上是將該軟體與 LillyDirect 自付藥房連接起來。

We will lean into additional partnerships along those lines with partners that really want to ensure that patients get access to authentic and FDA-approved medicines.

我們將與真正希望確保患者能夠獲得正品 FDA 批准藥品的合作夥伴建立更多合作關係。

Thank you, Patrik.

謝謝你，派崔克。

Next caller, please.

請下一位來電。

Chris Shibutani, Goldman Sachs.

高盛的 Chris Shibutani。

Apologies, I was on mute.

抱歉，我靜音了。

For the orforglipron launch, you previously stated that you're doing manufacturing scale-up to be prepared for a full launch at potential approval.

對於 orforglipron 的推出，您之前曾表示正在擴大生產規模，為可能獲得批准後的全面推出做好準備。

What is embedded in that assumption?

這個假設蘊含了什麼？

Can you talk a little bit about the approach for timing of orforglipron in terms of diabetes versus obesity?

您能否從糖尿病和肥胖症的角度談談奧格列龍的治療時機選擇方法？

Will it be simultaneous or one before the other?

它會同時發生還是先發生後發生？

US versus international?

美國與國際？

We certainly saw the injectable business do a prioritized US launch.

我們確實看到注射劑業務優先在美國推出。

And then should we also expect a similar kind of, quote, new product launch cadence with patient assistance programs and the implementation of channel tools like LillyDirect?

那麼，我們是否也應該期待類似的新產品發布節奏、患者援助計劃以及 LillyDirect 等通路工具的實施？

Should all those be at the outset?

這些都該從一開始嗎？

Thanks.

謝謝。

Thanks, Chris, for the very detailed question.

謝謝克里斯提出的這個非常詳細的問題。

We'll go to Dave to talk a bit about the orfor launch prep.

我們將和戴夫談論一些有關發射準備的事情。

Okay, waiting for all allowance.

好的，正在等待所有津貼。

Yeah, the goal here with orfor, because it's using different production systems that are available to us, it's a long cycle of processing to get a commercial product, but it's very predictable and we have access to those platforms inside and outside the company.

是的，orfor 的目標是，因為它使用了我們可用的不同生產系統，所以需要很長的周期才能獲得商業產品，但它非常可預測，而且我們可以訪問公司內部和外部的這些平台。

So we are building for a full launch in the normal pharma sense.

因此，我們正按照正常的製藥概念進行全面上市籌備。

And here, pointing out maybe the flip of the earlier question about demand, we have had to gate all these things to make sure we carefully match supply and demand for the injectables as a sort of competitor.

這裡，也許要指出的是先前關於需求的問題的反面，我們必須控制所有這些事情，以確保我們作為競爭對手仔細匹配注射劑的供需。

We do not plan for that with orfor.

我們沒有為 orfor 制定這樣的計劃。

So we will plan to launch or submit and have approvals and then launch in a full sense, including activities you're used to seeing for primary care products like sampling, co-pay, full formulary access, and globalization of orforglipron as rapidly as possible.

因此，我們計劃盡快推出或提交並獲得批准，然後全面推出，其中包括您習慣看到的初級保健產品活動，如抽樣、共同支付、全面處方訪問和 Orforglipron 的全球化。

And we're building capacities to do that, and hopefully, that will begin in early '26.

我們正在建立這方面的能力，希望能在26年初開始。

I think, as Dan mentioned, the first complete package for submission in the US will be obesity.

我認為，正如丹所提到的，美國提交的第一個完整項目將是肥胖症。

But we expect diabetes to shortly follow and then these other indications that have been discussed today.

但我們預計糖尿病很快就會出現，然後是今天討論過的其他症狀。

Hope that answers your question.

希望這能回答你的問題。

Great.

偉大的。

Thanks, Dave.

謝謝，戴夫。

Next question, please.

請回答下一個問題。

James Shin, Deutsche Bank.

德意志銀行的詹姆斯辛 (James Shin)。

Thank you.

謝謝。

Good morning.

早安.

Thanks for the question.

謝謝你的提問。

Another one for Dan on orforglipron.

另一個是 Dan 服用 orforglipron 的。

Appreciate the earlier comments on indexing orforglipron's efficacy to sema and the Phase 3 titration schedule.

感謝早先關於將 orforglipron 的療效與 sema 和第 3 階段滴定計劃聯繫起來的評論。

But can you go over how this titration schedule may impact the Phase 2 weight loss, A1c, and safety results published in Lancet and New England Journal?

但是，您能否介紹一下該滴定計畫將如何影響《柳葉刀》和《新英格蘭醫學雜誌》上發表的第 2 階段減重、A1c 和安全性結果？

Thank you.

謝謝。

Great.

偉大的。

Thanks, James, for the question.

謝謝詹姆斯提問。

We'll go to Dan to talk more about orfor.

我們將和丹進一步討論 orfor。

Yeah.

是的。

It's a good question, James, and reminiscent of the theme we had when the tirzepatide trials were going.

詹姆斯，這個問題問得很好，它讓我們回想起了我們在進行 tirzepatide 試驗時討論的主題。

It was a similar transition from a faster titration in Phase 2 to a more gradual titration in Phase 3.

這是一個類似的轉變，從第 2 階段的更快滴定到第 3 階段的更漸進的滴定。

I think that strategy served us well in the case of tirzepatide, and I'm hopeful for the same kind of outcomes in orforglipron, which is to say that it mitigated tolerability concerns.

我認為該策略在 tirzepatide 的案例中發揮了很好的作用，並且我希望 orforglipron 也能取得同樣的結果，也就是說，它減輕了耐受性的擔憂。

So the GI side effects that are just known to this class seem to be significantly mitigated by slower titration.

因此，這類患者已知的胃腸道副作用似乎可以透過較慢的滴定速度而顯著減輕。

And in longer studies, and the first study to read out is not the longest study we have here, we were still able to obtain the sort of plateau kind of efficacy that we expect for the mechanism.

在更長期的研究中，第一項研究並不是我們在這裡進行的最長的研究，我們仍然能夠獲得我們期望的機制的那種穩定功效。

So that's what we're hoping for orfor, better tolerability and similar efficacy as Phase 2.

所以這就是我們所希望的，具有更好的耐受性和與第 2 階段類似的功效。

Thank you, Dan.

謝謝你，丹。

Next question, please.

請回答下一個問題。

Trung Huynh, UBS.

瑞銀 (UBS) 的 Trung Huynh。

Hi, guys.

嗨，大家好。

Thanks for taking my question.

感謝您回答我的問題。

So for the first orfor study on diabetes, thank you so much for the level set there.

因此，對於第一次關於糖尿病的研究，非常感謝您在那裡設定的水平。

I have a similar question on retatrutide.

我對瑞他曲肽也有類似的疑問。

We noticed in your slides there was a Phase 3 readout in obesity and overweight patients with osteoarthritis of the knee as a potential event for '25.

我們注意到，您的幻燈片中顯示，肥胖和超重膝關節骨性關節炎患者的 3 期讀數是 '25 年的潛在事件。

So one of the primary endpoints is weight loss.

因此，主要終點之一就是減重。

Could that be a reasonable comp for the obesity studies in '26, unlike what you flagged with orfor and diabetes?

這是否可以作為 26 年肥胖研究的合理補充，不像您所標記的 orfor 和糖尿病？

Thanks for the question, Trung.

謝謝你的提問，Trung。

We'll go to Dan to talk about retatrutide.

我們將去找丹討論瑞特魯肽。

Yeah, I'm glad you asked the question.

是的，我很高興你問了這個問題。

It's a super smart question.

這是一個非常聰明的問題。

You're probably noticing that the osteoarthritis trial is shorter than any of the other ones.

您可能已經注意到，骨關節炎試驗比任何其他試驗的試驗時間都要短。

We've commented before that retatrutide is going to need longer trials.

我們之前曾評論說，瑞特魯肽需要更長時間的試驗。

Most of ours are 80-week plus trials to reach maximum efficacy.

我們的大部分試驗都經過了80週以上的時間才達到最大療效。

This is a 68-week trial.

這是一個為期 68 週的試驗。

I think we also know, at least by analogy from the sema trials that looked at osteoarthritis and obesity versus a more pure obesity population, that even for sema-like studies, there's a diminution of efficacy in terms of weight loss in the OA population for a number of reasons, including different baseline demographics, male, female, BMI, et cetera.

我想我們也知道，至少從針對骨關節炎和肥胖症與更純粹的肥胖症人群的 sema 試驗類比可知，即使是類似 sema 的研究，由於多種原因，包括不同的基線人口統計數據、男性、女性、BMI 等，骨關節炎人群的減肥效果也會降低。

So I think we know how to extrapolate out from the OA population to the general population, but I don't think you should take the OA population as a point estimate for what will be achieved in a broader obesity population.

因此，我認為我們知道如何從 OA 人群推斷到一般人群，但我不認為應該將 OA 人群作為更廣泛肥胖人群所取得成就的點估計值。

We should do quite a bit better than that.

我們應該做得更好。

Great.

偉大的。

Thanks, Dan.

謝謝，丹。

Next question, please.

請回答下一個問題。

Kripa Devarakonda, Truist Securities.

Devarakonda 先生，Truist Securities 成員。

Great.

偉大的。

Thanks for taking our question.

感謝您回答我們的問題。

This is Nicole on for Kripa.

這是 Nicole，代表 Kripa 發言。

Can we see some bima data this year, and do you still see some benefit with a muscle-preserving drug?

我們今年能否看到一些 bima 數據，您是否仍認為使用保護肌肉的藥物有一些好處？

The recent data from Vera showed preservation of lean mass, but no incremental weight loss.

Vera 的最新數據顯示，肌肉質量保留，但體重沒有逐漸減輕。

So bima, do you expect incremental weight loss or weight-neutral, but better body composition?

那麼 bima，您是否希望體重逐漸減輕或體重保持不變，但身體組成變得更好？

Is that what you're looking for?

這就是你要找的東西嗎？

Thanks for the question.

謝謝你的提問。

We'll go to Dan to talk a bit about how we're thinking about the bima data.

我們將和丹談談我們對 bima 數據的看法。

Yeah.

是的。

Thanks for a good question on bimagrumab.

感謝您就 bimagrumab 提出好問題。

I think our thesis here has been, in combination with tirzepatide, that we could get incremental weight loss or perhaps a similar weight loss, but as you point out, with preservation of what we call lean mass.

我認為我們的觀點是，結合 tirzepatide，我們可以獲得增量減肥或類似的減肥效果，但正如你所指出的，同時保持我們所謂的瘦體重。

I think to really show a benefit for combining the two drugs, we're probably going to either need to see the incremental weight loss, or we're going to need to see some real functional benefits to lean mass preservation.

我認為要真正顯示兩種藥物結合的益處，我們可能要么需要看到增量的體重減輕，要么需要看到對瘦體重保存的一些真正的功能性益處。

I think just lean mass on its own, we don't really know how to understand that.

我認為僅就瘦體重而言，我們真的不知道如何理解它。

We've previously noted that we don't see any signs that lean mass changes on tirzepatide or, to my knowledge, on any incretin are actually adverse in any way.

我們之前已經指出，我們沒有看到任何跡象表明 tirzepatide 或據我所知任何腸促胰島素引起的瘦體重變化實際上有任何不利影響。

On the other hand, growing muscle could be a positive in different ways.

另一方面，增長肌肉可以從不同方面產生積極影響。

So we're looking for new positive effects with bimagrumab.

因此，我們正在尋找比麥單抗的新正面作用。

The beginning of your question, I realized I didn't come to, which is when do we see the previous Phase 2 study, which was completed.

關於你問題的開頭，我意識到我沒有想起來，那就是我們什麼時候才能看到之前完成的第二階段研究。

We haven't been clear on exactly when we'll show that data, but this year is a safe assumption.

我們還不清楚何時會展示這些數據，但可以肯定地說今年會展示。

Great.

偉大的。

Thank you, Dan.

謝謝你，丹。

I think we have time for one last question.

我想我們還有時間回答最後一個問題。

Dave Risinger, Leerink Partners.

Dave Risinger，Leerink Partners。

Yes, thanks very much.

是的，非常感謝。

I was just hoping you could clarify the comment earlier.

我只是希望你能早點澄清這個評論。

I think there was a comment about additional PBM coverage coming in March.

我認為有人對 3 月即將推出的額外 PBM 報告做出評論。

I didn't quite catch that.

我沒太明白。

If you could just provide some more color and quantify the potential impact on the opportunity for script trends following that occurring.

如果您可以提供更多細節並量化發生這種情況對腳本趨勢機會的潛在影響。

Thank you.

謝謝。

Let me cover that, and then I'll just close.

讓我講一下這個，然後我就結束了。

I think, Dave, that was referred to Ebglyss, which is very new in cycle, and we do expect two of the three PBMs to cover it.

戴夫，我認為，這指的是 Ebglyss，它在周期中非常新，我們確實希望三個 PBM 中的兩個能夠涵蓋它。

And that gets us excited about activating consumers and raising awareness for that brand, except that Mounjaro have full PBM coverage already.

這讓我們對激活消費者和提高該品牌的知名度感到興奮，但 Mounjaro 已經擁有全面的 PBM 覆蓋範圍。

So great.

太棒了。

Let's conclude it there.

我們就到此為止吧。

Thanks for dialing in, everyone, and your interest in today's earnings call and, of course, in everything about Eli Lilly and company.

感謝大家的撥通電話，感謝你們對今天的財報電話會議的關注，當然還有你們對禮來公司及其公司一切事宜的關注。

If you've got follow-up questions or things we didn't cover in enough detail today in the Q&A, please follow up with the IR team.

如果您有後續問題或我們今天在問答中沒有詳細介紹的內容，請與 IR 團隊聯絡。

Mike Czapar leads that now.

目前，Mike Czapar 負責領導這項工作。

Everyone, have a great day.

祝大家有個愉快的一天。

Thank you.

謝謝。

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

女士們、先生們，今天的會議到此結束。

This conference will be made available for replay beginning at 1:00 PM today, running through March 13 at midnight.

本次會議將於今天下午 1:00 開始提供重播，並持續到 3 月 13 日午夜。

You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 443262.

您可以隨時撥打 (800) 332-6854 並輸入存取代碼 443262 來存取重播系統。

International dialers can call (973) 528-0005.

國際撥號者可撥打 (973) 528-0005。

Again, those numbers are (800) 332-6854 and (973) 528-0005 with the access code 443262.

再次強調，這些號碼是 (800) 332-6854 和 (973) 528-0005，接入碼為 443262。

Thank you for your participation.

感謝您的參與。

You may now disconnect your lines.

現在您可以斷開線路了。