禮來公司投資者關係資深副總裁 Joe Fletcher 歡迎與會者參加 2024 年第二季財報電話會議。這次電話會議強調了該公司收入的加速成長、關鍵管道里程碑、領導層變動、財務業績、 FDA 批准以及各個治療領域的進展。討論內容包括生產擴張、肥胖市場的競爭、藥物開發、監管參與和市場差異化。
該公司的目標是實現 30% 的中高營業利潤,並專注於創新和永續發展。下半年的計畫包括促銷管道、研發規模以及解決供需問題。整體而言,禮來公司對其未來前景和影響全球人類健康的承諾充滿信心。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q2 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 年第二季財報電話會議。
(Operator Instructions) I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations.
(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)。
Please go ahead.
請繼續。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Paul.
謝謝,保羅。
Good morning, everyone.
大家早安。
Thanks for joining us for Eli Lilly and Company's Q2 2024 Earnings Call.
感謝您參加禮來公司 2024 年第二季財報電話會議。
I'm Joe Fletcher, Senior Vice President of Investor Relations.
我是喬‧弗萊徹,投資人關係資深副總裁。
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; Gordon Brooks, Interim Chief Financial Officer; Anne White, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly International; Jake Van Naarden, President of Lilly Oncology; and Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA.
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;戈登‧布魯克斯,臨時財務長; Anne White,禮來神經科學公司總裁;伊利亞‧尤法 (Ilya Yuffa),禮來國際公司總裁; Jake Van Naarden,禮來腫瘤學總裁;以及禮來心臟代謝健康公司和禮來美國公司總裁 Patrik Jonsson。
And we're also joined by Michala Irons, Mike Sprengnether and Lauren Zierke of the IR team.
IR 團隊的 Michala Irons、Mike Sprengnether 和 Lauren Zierke 也加入了我們的行列。
During this conference call, we anticipate making projections and forward-looking statements based on our current expectations.
在本次電話會議中,我們預計將根據目前的預期做出預測和前瞻性陳述。
Our actual results could differ materially due to several factors, including those listed on slide 4.
由於多種因素(包括投影片 4 中列出的因素),我們的實際結果可能會有重大差異。
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出現重大差異的因素的更多資訊包含在我們最新的 10-K 表格以及隨後向 SEC 提交的文件中。
The information we provide about our products and pipeline is for the benefit of the investment community.
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。
It's not intended to be promotional and is not sufficient for prescribing decisions.
它的目的不是為了促銷,也不足以做出決策。
As we transition to our prepared remarks, please note that our commentary will focus on non-GAAP financial measures.
當我們轉向準備好的評論時,請注意,我們的評論將重點放在非公認會計準則財務指標。
Now I'll turn the call over to Dave.
現在我將把電話轉給戴夫。
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Thanks, Joe. It's an exciting time here at Lilly as our growth trajectory accelerated in the second quarter.
謝謝,喬。在禮來公司,這是一個令人興奮的時刻,我們的成長軌跡在第二季度加速。
Our investments in advancing innovative medicine and our focus on manufacturing expansion are bringing Lilly medicines to more people around the world.
我們對推動創新藥物的投資以及對生產擴張的關注正在將禮來藥品帶給世界各地更多的人。
On slide 5, you can see details of the financial performance in the second quarter and progress related to our strategic deliverables.
在投影片 5 上,您可以看到第二季財務表現的詳細資訊以及與我們的策略交付成果相關的進展。
Revenue grew 36% in Q2 with our new products growing nearly $3.5 billion compared to the same period last year.
第二季營收成長 36%,新產品與去年同期相比成長近 35 億美元。
US demand for Mounjaro and Zepbound is strong and growing as access and supply continue to expand.
美國對 Mounjaro 和 Zepbound 的需求強勁,並且隨著准入和供應的不斷擴大而不斷增長。
While weekly prescription volume was volatile in the first half of the year due to challenges fulfilling high demand, our progress on supply gives us confidence in our outlook.
儘管由於滿足高需求方面的挑戰,上半年每週處方量波動較大,但我們在供應方面的進展讓我們對前景充滿信心。
Q2 saw impressive performance across other areas of the business as well.
第二季其他業務領域的表現也令人印象深刻。
Excluding the sale of the rights to Baqsimi last year, non-incretin growth was 17% worldwide with growth spread across geographies, including 25% growth in the United States.
不包括去年出售 Baqsimi 的權利,全球非腸促胰島素增長了 17%,增長分佈在各個地區,其中美國增長了 25%。
And our $3 billion increase in revenue guidance reflects our expectation that momentum will accelerate through the balance of the year.
我們的收入指引增加了 30 億美元,反映出我們預計這一勢頭將在今年剩餘時間內加速。
We achieved several key pipeline milestones, including the approval of Kisunla, the brand name for donanemab in the US. for the treatment of Alzheimer's disease, the approval of Jaypirca in Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other BTK inhibitors, the submission of tirzepatide in the US. and the EU for the treatment of moderate to severe obstructive sleep apnea in adults with obesity and the positive top line results from the SUMMIT Phase III trial evaluating tirzepatide in adults with heart failure with preserved injection fraction and obesity.
我們實現了多個關鍵的管道里程碑,包括多納奈單抗 (donanemab) 在美國的品牌名稱 Kisunla 獲得批准。用於治療阿茲海默症、日本核准 Jaypirca 用於治療對其他 BTK 抑制劑抗藥性或不耐受的復發或難治性套細胞淋巴瘤患者、美國提交替澤帕肽。歐盟和歐盟用於治療肥胖成人中度至重度阻塞性睡眠呼吸中止症,並且 SUMMIT III 期試驗評估了替澤帕肽治療保留注射分數和肥胖的成人心臟衰竭的積極頂線結果。
Lilly now has a significant opportunity to create new medicines through a broad internal portfolio and active business development to support our long-term growth.
禮來公司現在擁有一個重大機會,可以透過廣泛的內部產品組合和積極的業務發展來創造新藥,以支持我們的長期成長。
In obesity, our strategy is to comprehensively address this global public health crisis, pursuing opportunities against every rational mechanism, indication and dosage form.
在肥胖方面,我們的策略是全面應對這場全球公共衛生危機,針對每一種合理的機制、適應症和劑型尋求機會。
We are investing broadly in this disease and now have 11 new molecules currently in the clinic across multiple indications.
我們正在對這種疾病進行廣泛投資,目前臨床上已有 11 種新分子,涵蓋多種適應症。
We're also investing in a wide range of late-stage Phase III programs.
我們也投資於一系列後期第三階段專案。
We recently shared the positive data of tirzepatide in OSA and HFpEF.
我們最近分享了替西帕肽治療 OSA 和 HFpEF 的正面數據。
Orforglipron, our oral GLP-1 small molecule, has a comprehensive Phase III program underway in diabetes and obesity with nine trials currently running and readouts starting mid next year.
Orforglipron 是我們的口服 GLP-1 小分子,針對糖尿病和肥胖症的全面 III 期計畫正在進行中,目前正在運行 9 項試驗,並於明年中期開始讀數。
With retatrutide, our GIP/GLP-1/Glucagon tri-agonist, we have initiated a broad Phase III development program studying the molecule in obesity, OSA, osteoarthritis, cardiovascular and renal outcomes as well as type 2 diabetes.
對於瑞他魯肽(我們的GIP/GLP-1/胰高血糖素三激動劑),我們啟動了一項廣泛的III 期開發計劃,研究該分子在肥胖、OSA、骨關節炎、心血管和腎臟結局以及2 型糖尿病方面的作用。
These readouts start in 2026.
這些讀數從 2026 年開始。
Our top priority remains executing on our ambitious manufacturing expansion agenda.
我們的首要任務仍然是執行雄心勃勃的製造業擴張議程。
In May, we announced plans to invest an additional $5.3 billion in our Lebanon, Indiana manufacturing site, bringing our total investment there to $9 billion.
5 月份,我們宣布計劃在印第安納州黎巴嫩製造基地追加投資 53 億美元,使我們在那裡的總投資達到 90 億美元。
We believe this is the largest single investment in synthetic medicine active pharmaceutical ingredient manufacturing in the history of the United States.
我們相信這是美國史上合成藥物活性藥物成分製造領域最大的單筆投資。
Importantly, this expansion will enhance capacity to manufacture active pharmaceutical ingredients for Zepbound and Mounjaro.
重要的是,此次擴建將提高 Zepbound 和 Mounjaro 活性藥物成分的生產能力。
Since 2020, we have committed more than $18 billion to build, upgrade or acquire facilities in the US. and Europe, and weâve began to see the benefit of these investments.
自 2020 年以來,我們已承諾投入超過 180 億美元在美國建造、升級或收購設施。和歐洲,我們已經開始看到這些投資的好處。
We are making near-term progress to ramp production, including at new sites like Research Trial Park, existing Lilly sites and contract manufacturing organizations.
我們近期正在擴大生產方面取得進展,包括研究試驗園等新工廠、禮來公司現有工廠和合約製造組織。
Our Concord North Carolina site is progressing well.
我們北卡羅來納州康科德工廠進展順利。
We're in the process of running validation and expect this facility will initiate production by the end of 2024 with product available to ship in 2025.
我們正在運行驗證,預計該工廠將於 2024 年底開始生產,產品將於 2025 年發貨。
We also continue to make progress on different presentations for tirzepatide.
我們也繼續在替西帕肽的不同演示方面取得進展。
We have now launched our multidose quick pen in multiple markets outside the US. with positive early indicators of patient adoption.
我們現已在美國以外的多個市場推出了多劑量快速筆。具有患者採用的正面早期指標。
And in Gordon's remarks, he will preview our plans to launch vials here in the US.
在戈登的演講中,他將預覽我們在美國推出小瓶產品的計畫。
Lastly, in terms of external innovation, in July, we announced a definitive agreement to acquire Morphic, a biopharma company developing oral integrin therapies for treatment of serious chronic diseases, including a Phase II asset being evaluated in inflammatory bowel disease.
最後,在外部創新方面,7 月,我們宣布達成收購Morphic 的最終協議,Morphic 是一家生物製藥公司,開髮用於治療嚴重慢性疾病的口服整合素療法,其中包括正在評估發炎性腸道疾病的II 期資產。
On slide 6, you'll see a list of key events since our Q1 call, including the milestones I mentioned earlier and several other important updates.
在幻燈片 6 上,您將看到自第一季電話會議以來的關鍵事件列表,包括我之前提到的里程碑和其他幾個重要更新。
As we announced in June, Anat Ashkenazi resigned as Lilly's Chief Financial Officer to become the CFO of Alphabet.
正如我們在 6 月宣布的那樣,阿納特·阿什肯納齊 (Anat Ashkenazi) 辭去禮來 (Lilly) 首席財務官職務,出任 Alphabet 首席財務官。
We wish Anat well in her new role and thank her for your partnership and leadership of our financial organization over the last 3 years.
我們祝福 Anat 在新職位上一切順利,並感謝她在過去 3 年裡對我們金融組織的合作和領導。
We have named Gordon Brooks Interim CFO as an internal and external search for Anatâs successor is currently underway.
我們已任命戈登布魯克斯 (Gordon Brooks) 為臨時首席財務官,目前正在內部和外部尋找阿納特的繼任者。
Gordon has been with the company for 29 years and also serves as our controller and the leader of the corporate strategy group for the company.
Gordon 在公司工作 29 年,也擔任我們的財務長和公司策略小組的領導者。
In other leadership news, Alonzo Weems, our Executive Vice President of Enterprise Risk Management and our Chief Ethics and Compliance Officer, will retire at the end of the year after 27 years of service.
在其他領導層新聞中,我們的企業風險管理執行副總裁兼首席道德與合規官 Alonzo Weems 將在服務 27 年後於今年年底退休。
And Melissa Seymour has joined the company as Executive Vice President of Global Quality and a member of the company's executive committee following Johna Norton's recent retirement.
在 Johna Norton 最近退休後,Melissa Seymour 加入公司,擔任全球品質執行副總裁和公司執行委員會成員。
I want to thank Alonzo for his many years of service and welcome Melissa to the Lilly team.
我要感謝阿朗佐多年來的服務,並歡迎梅莉莎加入禮來團隊。
Now let me turn the call over to Gordon to review our Q2 financial results.
現在讓我把電話轉給戈登,回顧我們第二季的財務表現。
Gordon Brooks - Interim Chief Financial Officer
Gordon Brooks - Interim Chief Financial Officer
Thanks, Dave.
謝謝,戴夫。
So I'm on slide 7, which summarizes the financial performance in the second quarter of 2024.
我在投影片 7 上總結了 2024 年第二季的財務表現。
Second quarter revenue growth of 36% was primarily driven by Mounjaro and Zepbound as well as Verzenio.
第二季營收成長 36% 主要是由 Mounjaro 和 Zepbound 以及 Verzenio 推動的。
When excluding revenue from the sale of rights to Baqsimi in Q2 of last year, revenue grew 46%.
如果排除去年第二季出售 Baqsimi 版權的收入,則收入成長了 46%。
Gross margin as a percent of revenue increased from 79.8% in Q2 of '23 to 82% in Q2 of '24.
毛利率佔營收的百分比從 23 年第二季的 79.8% 上升到 24 年第二季的 82%。
Gross margin in the quarter benefited from favorable product mix and higher realized prices, partially offset by higher production costs.
本季的毛利率受益於有利的產品組合和較高的實現價格,但部分被較高的生產成本所抵銷。
R&D expenses increased 15% driven by continued investment in our portfolio and in our people.
由於對我們的產品組合和員工的持續投資,研發費用增加了 15%。
Marketing, selling and administrative expenses increased 10%, primarily driven by promotional efforts associated with ongoing and future launches as well as investments in our people.
行銷、銷售和管理費用增加了 10%,主要是由於與當前和未來的產品發布相關的促銷活動以及對員工的投資。
Operating income increased 90% in Q2, driven by higher revenue from new products, partially offset by operating expense growth.
在新產品收入增加的推動下,第二季營業收入成長了 90%,但部分被營業費用成長所抵銷。
The effective tax rate on a non-GAAP basis was 16.5% in Q2 of '24 compared with 16.1% in Q2 of '23.
24 年第二季以非公認會計原則計算的有效稅率為 16.5%,而 23 年第二季為 16.1%。
The Q2 '24 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 '23 rate reflected the impact of earnings from the sale of rights for Baqsimi.
24 年第二季的稅率反映了高稅收管轄區的收入組合,而 23 年第二季的稅率則反映了 Baqsimi 權利出售收入的影響。
At the bottom line, we delivered earnings per share of $3.92 in Q2, an 86% increase compared to the prior year.
從底線來看,我們第二季的每股收益為 3.92 美元,比去年同期成長 86%。
Q2 '24 results include a negative impact of $0.14 from acquired IPR&D charges compared to $0.09 in the prior quarter, Q2 of '23.
2024 年第二季的業績包括因收購的 IPR&D 費用而產生的 0.14 美元的負面影響,而上一季(23 年第二季)的負面影響為 0.09 美元。
On slide 9, we quantify the effect of price, rate and volume on revenue growth.
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。
US revenue increased 42% in Q2.
第二季美國營收成長 42%。
Volume growth of 27% was driven by Zepbound, Mounjaro and Verzenio, partially offset by the sale of rights for Baqsimi in Q2 of '23 and declines in Trulicity.
27% 的銷售成長是由 Zepbound、Mounjaro 和 Verzenio 推動的,但部分被 23 年第二季 Baqsimi 權利的出售和 Trulicity 的下降所抵消。
Realized prices increased 15%, largely driven by Mounjaro access and savings card dynamics.
實際價格上漲了 15%,這主要是受到 Mounjaro 准入和儲蓄卡動態的推動。
As noted in our Q1 2024 earnings call, unprecedented demand for our incretin medicines led to wholesaler back orders at the end of Q1.
正如我們在 2024 年第一季財報電話會議中指出的,對我們的腸促胰島素藥物的前所未有的需求導致批發商在第一季末缺貨。
In Q2, we fulfilled the majority of these back orders, improving wholesaler stocking levels.
第二季度,我們履行了大部分延期交貨訂單,並提高了批發商的庫存水準。
We estimate that US Mounjaro and Zepbound aggregate sales in the second quarter were positively impacted by channel stocking that we estimate totaled high teens to mid-20s as a percent of US sales as we rebuilt inventory from extremely low levels in the spring and to account for the growth of these brands.
我們估計第二季美國Mounjaro 和Zepbound 的總銷售額受到了通路庫存的正面影響,我們估計通路庫存占美國銷售額的百分比高達10 到20 多歲,因為我們在春季從極低的水平重建了庫存,並考慮到這一點。
We are pleased that the group's supply situation is reflected on the FDA shortage website, which currently shows all doses of Mounjaro and Zepbound listed as available and the two lower doses of Trulicity as available.
我們很高興該集團的供應情況反映在 FDA 短缺網站上,該網站目前顯示所有劑量的 Mounjaro 和 Zepbound 均可用,以及兩種較低劑量的 Trulicity 可用。
While wholesaler back orders in the US have been reduced substantially, it's important to note that the pharmaceutical supply chain is complex, more so for medicines that require refrigeration and offer at several different doses.
儘管美國批發商的延期交貨訂單已大幅減少,但值得注意的是,藥品供應鏈非常複雜,對於需要冷藏並提供多種不同劑量的藥品來說更是如此。
These factors may continue to result in variability in the patient experience at the pharmacy counter.
這些因素可能會持續導致患者在藥局櫃檯的體驗發生變化。
While supply and demand has come into better balance, we expect increase in demand may result in periodic supply tightness for certain presentations and dose levels.
雖然供需已達到更好的平衡,但我們預計需求的增加可能會導致某些演示和劑量水平的周期性供應緊張。
We have a continued broad agenda to further increase supply, and we'll continue to look at all options.
我們有一個持續廣泛的議程來進一步增加供應,我們將繼續考慮所有選擇。
Today, we are excited to announce plans to further expand access for Zepbound with the launch of the 2.5-milligram and 5-milligram single-dose files in the coming weeks with more details to come at that time.
今天,我們很高興地宣布計劃進一步擴大 Zepbound 的使用範圍,在未來幾週內推出 2.5 毫克和 5 毫克單劑量文件,屆時將提供更多細節。
In Europe, revenue grew 20% in constant currency, primarily driven by Mounjaro launch uptake in the UK and Germany.
在歐洲,以固定匯率計算,營收成長了 20%,這主要得益於 Mounjaro 在英國和德國的推出。
We also had strong volume growth from Verzenio and Jardiance, which was partially offset by decreased volume from Trulicity.
Verzenio 和 Jardiance 的銷量也出現強勁增長,但 Trulicity 的銷量下降部分抵消了這一增長。
Japan performance was strong in the second quarter with 15% revenue growth in constant currency.
日本第二季表現強勁,以固定匯率計算營收成長 15%。
Volume growth of 21% was driven by uptake of Mounjaro and Verzenio.
Mounjaro 和 Verzenio 的採用推動了銷量成長 21%。
Moving to China.
搬到中國。
Q2 revenue increased 1% in constant currency.
以固定匯率計算,第二季營收成長 1%。
Growth was driven by Tyvyt, Olumiant and Taltz, partially offset by Trulicity and Cialis.
達伯舒、Olumiant 和 Taltz 推動了成長,但 Trulicity 和 Cialis 部分抵消了成長。
Mounjaro was recently approved in China for type 2 diabetes and chronic weight management.
Mounjaro 最近在中國已被批准用於第 2 型糖尿病和慢性體重管理。
We have not yet announced expected launch timing in this market.
我們尚未宣佈在該市場的預計推出時間。
Revenue in Rest of World increased 61% in constant currency, primarily driven by Mounjaro volume growth from demand and channel dynamics.
以固定匯率計算,世界其他地區的收入成長了 61%,這主要是受到需求和通路動態帶來的 Mounjaro 銷售成長的推動。
Slide 10 provides additional perspective on performance across our product categories.
投影片 10 提供了更多有關我們產品類別效能的視角。
Verzenio had solid growth in the second quarter across major geographies with worldwide sales increasing 44%, driven by the early breast cancer indication.
在早期乳癌適應症的推動下,Verzenio 第二季度在主要地區實現了穩健成長,全球銷售額成長了 44%。
Jaypirca revenue increased to $92 million worldwide, which included a $19 million partner milestone payment related to Japan.
Jaypirca 全球營收增至 9,200 萬美元,其中包括與日本相關的 1,900 萬美元合作夥伴里程碑付款。
Jaypirca continued impressive quarter-over-quarter growth, building on the brand's uptake from both the MCL and CLL patient populations.
Jaypirca 繼續保持令人印象深刻的季度環比增長,該品牌在 MCL 和 CLL 患者人群中得到廣泛應用。
Omvoh has launched in the US and 14 international markets with sales of $26 million in Q2.
Omvoh 已在美國和 14 個國際市場推出,第二季銷售額達 2,600 萬美元。
These launches continue to progress well with increasing patient starts.
隨著患者開始增加,這些產品的推出持續進展順利。
And in the US, we expect sales to accelerate as the product-specific J-code went live on July 1.
在美國,隨著特定於產品的 J 代碼於 7 月 1 日上線,我們預計銷售將會加速。
Mounjaro sales in Q2 were $3.1 billion globally, with $2.4 billion in the US.
Mounjaro 第二季全球銷售額為 31 億美元,其中美國銷售額為 24 億美元。
Revenue growth in the US reflected continued strong demand as well as the improved channel dynamics discussed earlier.
美國的收入成長反映了持續強勁的需求以及前面討論的管道動態的改善。
We're seeing solid uptake in Mounjaro outside the US, with sales in Q2 totaling $677 million.
我們看到 Mounjaro 在美國以外的銷售量強勁,第二季銷售額總計 6.77 億美元。
In the first half of the year, we launched the Kwikpen presentation in the UK, Germany and the UAE.
今年上半年,我們在英國、德國和阿聯酋推出了 Kwikpen 演示。
So far in Q3, we've also launched Mounjaro Kwikpen in Spain and plan to launch in additional markets throughout 2024.
到目前為止,在第三季度,我們還在西班牙推出了 Mounjaro Kwikpen,並計劃在 2024 年在其他市場推出。
In Q2, worldwide Trulicity revenue declined 31%.
第二季度,Trulicity 全球營收下降了 31%。
US Trulicity revenue decreased 36% driven by lower volume, primarily due to competitive dynamics and supply constraints, partially offset by improved wholesaler stocking levels on certain doses.
美國 Trulicity 收入下降 36%,原因是銷量下降,這主要是由於競爭動態和供應限制,但部分劑量被批發商庫存水準提高所抵消。
Turning to slide 11, we have an update on the US launch of Zepbound.
轉向幻燈片 11,我們了解了 Zepbound 在美國推出的最新情況。
We've seen exceptional growth trends for Zepbound that have accelerated as production has ramped leading to sales of over $1.2 billion in Q2.
我們看到 Zepbound 的非凡成長趨勢隨著產量的增加而加速,導致第二季銷售額超過 12 億美元。
We are rapidly building our formulary coverage for Zepbound in the US and as of July 1 had approximately 86% access in the commercial segment.
我們正在快速建立 Zepbound 在美國的處方覆蓋範圍,截至 7 月 1 日,商業領域的覆蓋率約為 86%。
We estimate over 50% of employers have opted into anti-obesity medicine coverage and see that modestly growing as we work to expand coverage.
我們估計超過 50% 的雇主選擇了抗肥胖藥物承保範圍,並且隨著我們努力擴大承保範圍,這一比例將適度增長。
On slide 12, we provide an update on our capital allocation.
在投影片 12 上,我們提供了資本配置的最新資訊。
Slide 13 shows our updated 2024 financial guidance.
投影片 13 顯示了我們更新的 2024 年財務指引。
We are raising our full year revenue outlook by $3 billion to be between $45.4 million and $46.6 billion.
我們將全年營收預期調高 30 億美元,達到 4,540 萬美元至 466 億美元之間。
This increase is due to strong performance across our non-incretin medicines as well as Mounjaro and Zepbound.
這一增長得益於我們的非腸促胰島素藥物以及 Mounjaro 和 Zepbound 的強勁表現。
Additionally, we have improved clarity into the timing and pace of our production expansion and Mounjaro launches outside the US.
此外,我們也進一步明確了生產擴張和 Mounjaro 在美國以外地區推出的時間和節奏。
We achieved a number of supply-related milestones in Q2 and have increased confidence regarding our expectation that production of salable doses of incretin medicines in the second half of 2024 will be at least 1.5 times the salable doses in the second half of 2023.
我們在第二季度實現了許多與供應相關的里程碑,並對我們的預期更有信心,即2024 年下半年腸促胰島素藥物的可銷售劑量產量將至少是2023 年下半年可銷售劑量的1.5 倍。
Based on the midpoint of the range, our updated guidance implies revenue growth of 38% in the second half of the year, following 31% in the first half.
根據該範圍的中點,我們更新後的指引意味著下半年營收將成長 38%,而上半年則為 31%。
In the second half of the year, we are expecting more significant growth in Q4 compared to Q3.
下半年,我們預計第四季將比第三季有更顯著的成長。
Given the update to revenue guidance, we now expect the ratio of gross margin less OpEx divided by revenue to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis.
鑑於收入指引的更新,我們現在預計毛利率減去營運支出除以收入的比率在報告基礎上將在 36% 至 38% 之間,在非 GAAP 基礎上將在 37% 至 39% 之間。
For other income and expense, we now expect between $525 million and $425 million of expense on a reported basis, and between $400 million and $300 million of expense on a non-GAAP basis.
對於其他收入和支出,我們現在預計報告費用在 5.25 億美元到 4.25 億美元之間,按照非公認會計準則計算費用在 4 億美元到 3 億美元之間。
Both ranges reflect lower expected net interest expense and the reported range reflects net losses on investments in equity securities through Q2 of '24.
這兩個範圍都反映了較低的預期淨利息支出,報告的範圍反映了截至 24 年第二季的股本證券投資淨虧損。
We have increased our estimated effective tax rate to be approximately 15%, driven by changes in our forecasted mix of earnings in higher tax jurisdictions.
由於我們對高稅收管轄區的預測收益組合的變化,我們將估計的有效稅率提高至約 15%。
Earnings per share is now expected to be in the range of $15.10 to $15.60 on a reported basis and $16.10 to $16.60 on a non-GAAP basis.
目前預計每股收益在報告基礎上為 15.10 美元至 15.60 美元,根據非公認會計準則計算為 16.10 美元至 16.60 美元。
Both ranges reflect the updates mentioned earlier as well as acquired IPR&D charges through Q2 of $0.24. The reported range includes a charge in Q2 of '24 associated with anticipated litigation payments.
這兩個範圍都反映了前面提到的更新以及截至第二季的 0.24 美元的 IPR&D 費用。報告的範圍包括 24 年第二季與預期訴訟付款相關的費用。
Now I'll turn the call over to Dan to highlight our progress on R&D.
現在我將把電話轉給 Dan,強調我們在研發方面的進展。
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Thanks, Gordon.
謝謝,戈登。
It's been another busy quarter.
這又是一個忙碌的季度。
I'll start with comments on the Kisunla FDA approval, then the tirzepatide heart failure Phase III readout.
我將從 Kisunla FDA 批准的評論開始,然後是替西帕肽心臟衰竭 III 期讀數。
Then finally, I'll cover the rest of the updates for the quarter.
最後,我將介紹本季的其餘更新。
We are, of course, very excited about the FDA approval of Kisunla for treatment of Alzheimer's disease.
當然,我們對 FDA 批准 Kisunla 用於治療阿茲海默症感到非常興奮。
This followed the June Advisory Committee meeting where we had another chance to present and discuss the compelling data package characterizing the safety and efficacy of this medicine.
在此之前,我們在六月的諮詢委員會會議上再次有機會展示和討論描述該藥物安全性和有效性的令人信服的數據包。
We were pleased by the discussion of the FDA advisers, particularly with regard to our data supporting stopping of Kisunla therapy when amyloid plaques are removed to minimal levels.
我們對 FDA 顧問的討論感到高興,特別是我們的數據支持當澱粉樣斑塊去除到最低水平時停止 Kisunla 治療。
In our trial, nearly half of study participants completed their course of treatment with Kisunla in 12 months.
在我們的試驗中,近一半的研究參與者在 12 個月內完成了 Kisunla 的治療過程。
We believe limited duration therapy, along with a once monthly infusion schedule, could result in lower patient out-of-pocket treatment costs and fewer infusions required.
我們相信,有限持續時間的治療以及每月一次的輸液計劃可能會降低患者的自付費用治療費用並減少所需的輸液量。
The vote was unanimously positive on all questions presented.
投票對提出的所有問題都一致贊成。
Then a few weeks later, the FDA approved Kisunla, including labeling that physicians may consider stopping dosing of Kisunla based on reduction of amyloid plaques.
幾週後,FDA 批准了 Kisunla,並註明醫生可以考慮根據澱粉樣蛋白斑塊的減少情況停止服用 Kisunla。
Following the July approval, we launched Kisunla, and we're delighted to see that patients have already begun receiving this new Lilly medicine as part of clinical practice.
繼 7 月獲得批准後,我們推出了 Kisunla,我們很高興看到患者已經開始接受這種新的禮來藥物作為臨床實踐的一部分。
We note that Kisunla is broadly covered for Medicare patients through approved CED registries.
我們注意到,Kisunla 透過經批准的 CED 登記處廣泛涵蓋 Medicare 患者。
Regulatory reviews continue around the world with potential action yet this year in several countries.
世界各地的監管審查仍在繼續,一些國家今年可能會採取行動。
We're pleased to have recently received a positive opinion for donanemab from the Pharmaceuticals and Medical Devices Agency in Japan.
我們很高興最近收到日本藥品和醫療器材管理局對 donanemab 的正面評價。
And finally, our Phase III prevention study, TRAILBLAZER-ALZ-3, continues to progress as planned.
最後,我們的 III 期預防研究 TRAILBLAZER-ALZ-3 繼續按計劃取得進展。
Moving to tirzepatide.
轉向替澤帕肽。
On slide 14, you'll see the recent positive results of our SUMMIT Phase III trial, which evaluated tirzepatide for the treatment of heart failure with preserved ejection fraction and obesity.
在幻燈片 14 上,您將看到我們 SUMMIT III 期試驗的最新積極結果,該試驗評估了替西帕肽治療射血分數保留的心臟衰竭和肥胖症的效果。
This study demonstrated statistically significant improvements in both primary endpoints for tirzepatide maximum tolerated dose compared to placebo.
該研究表明,與安慰劑相比,替西帕肽最大耐受劑量的兩個主要終點均具有統計學顯著改善。
In the first primary endpoint, tirzepatide reduced the risk of worsening heart failure by 38% compared to placebo as measured by a composite outcome of heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death.
在第一個主要終點中,與安慰劑相比,替澤帕肽將心臟衰竭惡化的風險降低了38%,這是透過心臟衰竭緊急就診或住院、口服利尿劑強化或心血管死亡的綜合結果來衡量的。
The median follow-up for this endpoint was 104 weeks.
此終點的中位追蹤時間為 104 週。
In the second primary endpoint, tirzepatide significantly improved heart failure symptoms and physical limitations compared to placebo as measured by the Kansas City Cardiomyopathy Questionnaire, KCCQ Clinical Summary score.
在第二個主要終點中,根據堪薩斯城心肌病變問卷、KCCQ 臨床總結評分,與安慰劑相比,替澤帕肽顯著改善心臟衰竭症狀和身體限制。
Main changes from baseline in this measurement is 24.8 points for tirzepatide, while placebo was 15 points based on the efficacy estimand at 52 weeks.
根據 52 週時的療效估計值,替西帕肽相對於基線的主要變化為 24.8 分,而安慰劑為 15 分。
All key secondary endpoints were met in the study, including mean body weight reduction of 15.7% compared to 2.2% for placebo.
研究中所有關鍵的次要終點均已滿足,包括平均體重減輕 15.7%,安慰劑組為 2.2%。
The overall safety profile of tirzepatide in the SUMMIT trial was consistent with previously reported tirzepatide studies, including SURMOUNT and SURPASS.
SUMMIT 試驗中替澤帕肽的整體安全性與先前報告的替澤帕肽研究一致,包括 SURMOUNT 和 SURPASS。
We will present detailed results at an upcoming medical meeting and submit to a peer review journal.
我們將在即將舉行的醫學會議上展示詳細的結果,並提交給同行評審期刊。
We plan to submit results to the FDA and other regulatory agencies starting later this year.
我們計劃從今年稍後開始向 FDA 和其他監管機構提交結果。
In other updates across our portfolio, slide 15 shows select pipeline opportunities as of August 6.
在我們投資組合的其他更新中,幻燈片 15 顯示了截至 8 月 6 日的精選管道機會。
Slide 16 shows potential key events for the year.
幻燈片 16 顯示了今年潛在的關鍵事件。
I'll start with updates in cardiometabolic health, which is the new name of our internal business, formerly known as Lilly Diabetes and Obesity.
我將從心臟代謝健康的最新情況開始,這是我們內部業務的新名稱,以前稱為禮來糖尿病和肥胖業務。
In June, we published detailed results for our Phase III trials of tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity in the New England Journal of Medicine, and we presented results at the American Diabetes Association Meeting.
6 月,我們在《新英格蘭醫學雜誌》上發表了替西帕肽治療中度至重度阻塞性睡眠呼吸中止症和肥胖症的 III 期試驗的詳細結果,並在美國糖尿病協會會議上介紹了結果。
All primary and key secondary endpoints were achieved in these studies.
這些研究中實現了所有主要和關鍵次要終點。
Notably, in one of our key secondary endpoints, as shown on slide 17, tirzepatide demonstrated that up to 51.5% of participants met the criteria for disease resolution of sleep apnea.
值得注意的是,在我們的關鍵次要終點之一(如幻燈片 17 所示)中,替西帕肽證明高達 51.5% 的參與者符合睡眠呼吸中止症疾病緩解的標準。
We've now submitted tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity to the FDA as well as the EMA.
我們現已向 FDA 和 EMA 提交了用於治療中度至重度阻塞性睡眠呼吸中止症和肥胖的替澤帕肽。
We are pleased that the FDA has granted breakthrough therapy designation, and we expect US regulatory action as early as the end of 2024, which will be dependent on the FDA granting priority review.
我們很高興 FDA 已授予突破性療法認定,我們預計美國最早將於 2024 年底採取監管行動,這將取決於 FDA 是否給予優先審查。
Also in June, we published results in the New England Journal from our Phase II trial of tirzepatide for metabolic dysfunction associated steatohepatitis, or MASH, with Stage II or III fibrosis and we presented these results at the European Association for the Study of the Liver Congress.
同樣在6 月,我們在《新英格蘭雜誌》上發表了替西帕肽治療伴有II 期或III 期纖維化的代謝功能障礙相關脂肪性肝炎(MASH) 的II 期試驗結果,並在歐洲肝臟研究協會大會上介紹了這些結果。
We are pleased to show that in a secondary endpoint, more than half of the patients taking tirzepatide achieved improvement in fibrosis at 52 weeks as shown on slide 18.
我們很高興地表明,在次要終點中,超過一半服用替澤帕肽的患者在 52 週時實現了纖維化的改善,如幻燈片 18 所示。
We're engaged with regulatory authorities on a potential Phase III registration strategy, and we're also encouraged by the potential read-through of these results to retatrutide, which also showed significant improvements in liver fats in Phase II.
我們正在與監管機構就潛在的第三階段註冊策略進行合作,我們也對瑞他魯肽的這些結果的潛在解讀感到鼓舞,該結果也顯示出第二階段肝臟脂肪的顯著改善。
This quarter, we also announced top line data from two Phase III trials for our once weekly insulin called efsitora alfa, the QWINT-2 and QWINT-4 trials for the treatment of type 2 diabetes each met their primary endpoints of non-inferior A1c reduction.
本季度,我們也公佈了每週一次的胰島素efsitora alfa 的兩項III 期試驗的主要數據,即用於治療2 型糖尿病的QWINT-2 和QWINT-4 試驗,均達到了非劣質A1c 降低的主要終點。
QWINT-2 compared efsitora to once-daily insulin degludec for 52 weeks in insulin naive adults.
QWINT-2 在未接受胰島素治療的成年人中比較了 efsitora 與每日一次的德谷胰島素,為期 52 週。
QWINT-4 compared efsitora to insulin glargine for 26 weeks in adults previously treated with daily basal insulin and at least two injections per day of mealtime insulin.
QWINT-4 在先前接受每日基礎胰島素和每天至少注射兩次進餐胰島素治療的成年人中,對 efsitora 與甘精胰島素進行了 26 週的比較。
In both QWINT-2 and QWINT-4, efsitora was safe and well tolerated.
在 QWINT-2 和 QWINT-4 中,efsitora 都是安全且耐受性良好的。
Detailed trial results will be presented in September at the European Association for the Study of Diabetes Annual Meeting.
詳細的試驗結果將於九月在歐洲糖尿病研究協會年會上發表。
We look forward to sharing additional data from the QWINT program later this year.
我們期待在今年稍後分享 QWINT 計劃的更多數據。
We are pleased with our progress to provide breakthrough innovation to patients who require insulin, progressing our glucose sensing insulin receptor agonist molecule in Phase I and investing in approaches aimed at disease modification for type 1 diabetes, such as islet cell therapy.
我們很高興能夠為需要胰島素的患者提供突破性創新,將我們的葡萄糖感應胰島素受體激動劑分子推進到 I 期,並投資於旨在改善 1 型糖尿病疾病的方法,例如胰島細胞療法。
In other late-phase updates, we've initiated TRIUMPH-OUTCOMES, a Phase III trial evaluating cardiovascular outcomes and renal function for patients taking retatrutide.
在其他後期更新中,我們啟動了 TRIUMPH-OUTCOMES,這是一項評估服用瑞他魯肽患者的心血管結局和腎功能的 III 期試驗。
Earlier in our cardiometabolic pipeline, you'll see additional incretin molecules in Phase I. Incretins are an important part of our portfolio strategy and having multiple molecules in clinical development offers us potential optionality as we look at opportunities to help patients across mechanisms, indications, dosages, formulations and treatment schedules.
在我們的心臟代謝管道的早期,您將在I 期中看到其他腸促胰島素分子。 ,因為我們正在尋找機會幫助患者跨越機制、適應症、劑量、配方和治療方案。
To highlight a few: GLP-1 NPA II is a small molecule non-peptide agonist of the GLP-1 receptor designed for once daily oral administration.
強調幾點:GLP-1 NPA II 是一種 GLP-1 受體的小分子非勝肽激動劑,設計用於每日口服一次。
We expect this asset to move to Phase II later this year, so we now identify it on our pipeline slide whereas it had previously been listed as not disclosed.
我們預計該資產將在今年稍後進入第二階段,因此我們現在在我們的管道幻燈片上識別它,而之前它被列為未披露。
Given the diversity of indications to potentially pursue with incretins, we are excited about the possibility of having another oral option to help more patients with different diseases.
鑑於腸促胰島素可能適應症的多樣性,我們很高興有可能有另一個口服選擇來幫助更多患有不同疾病的患者。
We also highlight today the GIP/GLP-1 coagonist III, which is a next-generation dual agonist molecule and we are planning to explore weekly and monthly dosing given its longer half-life.
今天我們也重點介紹 GIP/GLP-1 共激動劑 III,它是下一代雙激動劑分子,鑑於其半衰期較長,我們計劃探索每周和每月給藥。
Elsewhere in our cardiometabolic health portfolio, we have stopped development of our NRG4 agonist as the profile was insufficient for further clinical development.
在我們的心臟代謝健康產品組合中的其他地方,我們已經停止了 NRG4 激動劑的開發,因為其概況不足以進行進一步的臨床開發。
Turning to oncology.
轉向腫瘤學。
We are pleased that Jaypirca has now been approved in Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other BTK inhibitors.
我們很高興 Jaypirca 現已在日本獲準用於治療對其他 BTK 抑制劑抗藥性或不耐受的復發或難治性套細胞淋巴瘤患者。
In early phase oncology, we've initiated the Phase I trial for a second Nectin-4 ADC.
在早期腫瘤學領域,我們已經啟動了第二個 Nectin-4 ADC 的 I 期試驗。
We view this as an important target and having two compounds in the clinic provides more opportunities to improve outcomes for patients.
我們認為這是一個重要的目標,在臨床上使用兩種化合物可以為改善患者的治療結果提供更多機會。
We've also initiated a Phase I trial for our ADC targeting the folate receptor.
我們也啟動了針對葉酸受體的 ADC 的 I 期試驗。
This asset, which came from our acquisition of Mablink is q next-generation construct designed to have efficacy at all folate receptor expression levels and with an improved therapeutic index relative to existing agents.
這項資產來自我們對 Mablink 的收購,是下一代構建體,旨在對所有葉酸受體表達水平均有效,並且相對於現有藥物具有改進的治療指數。
We're also announcing that we've terminated the LOXO-783 program, which targeted PI3 kinase alpha.
我們也宣布我們已經終止了針對 PI3 激酶 α 的 LOXO-783 計畫。
We evaluated the ongoing clinical data from the program and compared the molecule to next-generation candidates that we have progressed from our discovery efforts.
我們評估了該計畫正在進行的臨床數據,並將該分子與我們在發現工作中取得的下一代候選藥物進行了比較。
We believe our next molecules have greater potential to benefit patients and we look forward to putting our next candidate into the clinic in 2025 and sharing more about its profile later this year.
我們相信我們的下一個分子具有更大的潛力使患者受益,我們期待在 2025 年將我們的下一個候選分子投入臨床,並在今年稍後分享更多有關其概況的信息。
In immunology, we've now submitted mirikizumab for the treatment of moderately to severely active Crohn's disease in Japan.
在免疫學方面,我們現已在日本提交了用於治療中度至重度活動性克隆氏症的 mirikizumab。
We've terminated development for our GITR antagonist due to insufficient efficacy.
由於功效不足,我們已終止 GITR 拮抗劑的開發。
We also announced our acquisition of Morphic, and pending completion of the deal we plan to reflect the oral A4b7 integrin inhibitor MORF-057 in Phase II for ulcerative colitis and Crohn's disease.
我們也宣布收購 Morphic,在交易完成之前,我們計劃將口服 A4b7 整合素抑制劑 MORF-057 納入治療潰瘍性結腸炎和克隆氏症的 II 期臨床。
Finally in neuroscience, our anti-tau small molecule OGA inhibitor recently concluded its Phase II study in early symptomatic Alzheimer's disease.
最後,在神經科學領域,我們的抗 tau 小分子 OGA 抑制劑最近完成了早期症狀性阿茲海默症的 II 期研究。
OGA failed to meet the primary endpoint of decreasing the change from baseline as measured by iADRS in either of the two dose levels tested.
在測試的兩個劑量水平中,OGA 未能達到 iADRS 測量的減少相對基線變化的主要終點。
We're reviewing the data for presentation of detailed results of the study at the Clinical Trials in Alzheimer's disease Conference later this year.
我們正在審查數據,以便在今年稍後的阿茲海默症臨床試驗會議上展示研究的詳細結果。
While this negative outcome is disappointing, we remain committed to tau as a high conviction target in Alzheimer's disease and plan to continue studying tau biology.
雖然這一負面結果令人失望,但我們仍然致力於將 tau 蛋白作為阿茲海默症的一個高度可信的靶標,並計劃繼續研究 tau 蛋白生物學。
I'll now turn the call back to Dave for closing remarks.
現在我將把電話轉回給戴夫,讓他致閉幕詞。
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Thanks, Dan.
謝謝,丹。
Before we go to Q&A, let me briefly sum up our progress in the second quarter.
在進行問答之前,我先簡單總結一下我們第二季的進展。
Exceptional revenue growth in Q2 was driven by Mounjaro, Zepbound and Verzenio.
第二季營收的出色成長是由 Mounjaro、Zepbound 和 Verzenio 推動的。
We are pleased with the ramp in production in the first half of the year and expect continued expansion ahead.
我們對上半年產量的成長感到滿意,並預計未來將繼續擴張。
Significant advances in our pipeline include the approval of Kisunla for Alzheimer's disease, the submission of tirzepatide for moderate to severe obstructive sleep apnea and obesity in the US and Europe and positive results from the Phase III study of tirzepatide for heart failure with preserved injection fraction and obesity.
我們的產品線取得了重大進展,包括批准用於治療阿茲海默症的Kisunla、在美國和歐洲提交用於治療中重度阻塞性睡眠呼吸中止症和肥胖症的替澤帕肽,以及保留注射分數和用於治療心臟衰竭的替澤帕肽III 期研究的積極結果。
We are investing in product launches, the advancement of our pipeline as well as our ambitious manufacturing expansion agenda.
我們正在投資於產品發布、產品線的進步以及雄心勃勃的製造擴張議程。
All of this and the incredible work of our teams around the world give Lilly leadership confidence that we have a very bright future ahead and better opportunity than at any time in our company's history to impact human health on a global scale.
所有這些以及我們在世界各地的團隊所做的令人難以置信的工作使禮來領導層充滿信心,相信我們擁有非常光明的未來,並且有比我們公司歷史上任何時候都更好的機會在全球範圍內影響人體健康。
Now I'll turn the call over to Joe to moderate the Q&A session.
現在我將把電話轉給喬來主持問答環節。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Dave.
謝謝,戴夫。
We'd like to take questions from as many callers as possible and to conclude our call in a timely manner.
我們希望回答盡可能多的來電者的問題,並及時結束我們的通話。
(Operator Instructions) So Paul, please provide the instructions for the Q&A, and we're ready for the first caller.
(操作員說明)保羅,請提供問答說明,我們已準備好迎接第一個來電者。
Operator
Operator
(Operator Instructions) And the first question today is coming from Seamus Fernandez from Guggenheim.
(操作員說明)今天的第一個問題來自古根漢的 Seamus Fernandez。
Seamus Fernandez
Seamus Fernandez
And just I'll stick with my one question.
我只會堅持我的一個問題。
It really is on your awareness of ASP movements in the market, so the average selling price.
這實際上取決於您對市場 ASP 趨勢的了解,以及平均售價。
By our calculations, when we sort of look at the ASP averages, removing rebates, inventory, et cetera, relative to comments made yesterday on Novo's call, I'm just trying to get a better understanding of what you're seeing in the market with regard to average selling price.
根據我們的計算,當我們查看平均售價(剔除回扣、庫存等)時,相對於昨天在 Novo 電話會議上發表的評論,我只是想更好地了解您在市場上看到的情況關於平均售價。
The prices look actually reasonably close to us with the tirzepatide franchise having higher sort of ASP per script, but not dramatically higher given concerns of real pricing deterioration.
價格看起來實際上相當接近我們,因為替西帕肽特許經營權的每個腳本的平均售價較高,但考慮到實際價格惡化的擔憂,價格並沒有大幅提高。
I guess the only question that I have here is, what are you seeing from an ASP perspective?
我想我在這裡唯一的問題是,您從 ASP 的角度看到了什麼?
And do you see this as kind of a natural evolution of this market as competition emerges as we saw with Ozempic historically and Trulicity in 2019?
您是否認為這是該市場隨著競爭的自然演變,正如我們在歷史上的 Ozempic 和 2019 年的 Trulicity 中看到的那樣?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Seamus.
謝謝,西莫。
I think I'll go to Gordon.
我想我會去戈登。
Do you want to touch on that, or Patrick?
你想談談這個嗎,還是派崔克?
Gordon Brooks - Interim Chief Financial Officer
Gordon Brooks - Interim Chief Financial Officer
Sure.
當然。
Seamus, thanks for the question.
西莫,謝謝你的提問。
Yes.
是的。
So just on price trends, initial favorability in the first half of the year was driven by Mounjaro.
因此,就價格趨勢而言,上半年最初的好感度是由 Mounjaro 推動的。
That goes away in the second half of the year as the co-pay program moves out of the base period.
隨著共同支付計畫結束基期,這種情況將在今年下半年消失。
In terms of pricing, we see stable pricing sequentially across quarters in '24.
在定價方面,我們看到 24 年各季度的定價連續穩定。
So nothing unusual, Q1 to Q2 and our guidance Q3 and Q4 continue stable sequential pricing.
因此,沒有什麼異常,第一季到第二季以及我們的指引第三季和第四季繼續穩定的連續定價。
For the second half of the year when you don't have the Mounjaro dynamic pricing the second half will be similar to prior year pricing.
在下半年,當您沒有 Mounjaro 動態定價時,下半年的定價將與去年的定價類似。
So those are kind of the dynamics we see in pricing.
這些就是我們在定價上看到的動態。
Operator
Operator
Terence Flynn from Morgan Stanley.
摩根士丹利的特倫斯弗林。
Terence Flynn - Analyst
Terence Flynn - Analyst
Congrats on all the progress on the manufacturing.
祝賀製造方面的所有進展。
Maybe just a two-part for me on that one.
也許對我來說這只是兩個部分。
Just wondering if you're initial guidance for the at least 1.5-fold increase in sellable doses include the Zepbound bound star vials that you're rolling out in the US or if that's a potential driver of upside?
只是想知道您對可售劑量增加至少 1.5 倍的初步指導是否包括您在美國推出的 Zepbound 綁定星形小瓶,或者這是否是上漲的潛在驅動力?
And then as we think about RTP, I know you continue to make progress there.
然後,當我們考慮 RTP 時,我知道您在這方面繼續取得進展。
The scripts suggest you're at about one-third of the way through the ramp to peak.
腳本顯示您正處於到達高峰的大約三分之一的路程。
But this inventory restock that you talked about today suggests maybe more of a meaningful step-up.
但您今天談到的庫存補充表明,這可能是更有意義的升級。
So just can you quantify for us where you are in the ramp in RTP?
那麼您能否為我們量化一下您在 RTP 中處於哪個階段?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Yes, sure.
是的,當然。
Dave, do you want to hop in?
戴夫,你想跳進去嗎?
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Yes, I can.So I think what we're saying today is just reiterating the 1.5 is sort of like a floor on how we think about second half volume.
是的,我可以。 所以我認為我們今天所說的只是重申 1.5 有點像我們對後半部音量的看法的下限。
I would say the vials are part of that.
我想說的是小瓶子是其中的一部分。
But given we have about 20 weeks left in the year, there's a limit to how much of that will ship anyway.
但考慮到今年還剩下大約 20 週,無論如何,運送的數量是有限的。
But they certainly open up a node of the most constrained part of the supply chain, which is fill/finish in the final container closure and it uses different lines obviously, than syringes or cartridges.
但它們確實開闢了供應鏈中最受限制的部分的節點,即最終容器封閉件中的填充/完成,並且它顯然使用與注射器或藥筒不同的生產線。
So it just adds to our capacity.
所以它只會增加我們的能力。
Probably the most meaningful part of that will show up in early '25 to be honest, as that new form ramps and details on that rollout will be coming in the coming weeks.
老實說,其中最有意義的部分可能會在 25 年初出現,因為新形式的升級和推出的細節將在未來幾週內公佈。
As it relates to RTP, I wouldn't read through that the Q2 step-up in volume we shipped was primarily due to RTP.
由於它與 RTP 相關,我不會仔細閱讀我們出貨量的成長主要是由於 RTP 所致。
That site is on track, and we are steadily escalating production per our goals.
工廠正在步入正軌,我們正在按照我們的目標穩步提高產量。
I also mentioned Concord is doing well against its time schedule, and we expect product out of that site end of this year, early next year.
我還提到 Concord 在其時間表上表現良好,我們預計該網站的產品將在今年年底明年初推出。
But rather, maybe performance out of the totality of the network that allowed us to recover wholesaler inventory levels in Q2 and now come off the FDA shortage list.
相反,也許是整個網路的表現讓我們在第二季度恢復了批發商的庫存水平,現在已經脫離了 FDA 的短缺清單。
It's more just overall performance across many, many nodes of our supply network.
它更重要的是我們供應網路中許多節點的整體效能。
Operator
Operator
Chris Schott from JPMorgan.
摩根大通的克里斯·肖特。
Christopher Schott - Analyst
Christopher Schott - Analyst
Congrats all the progress.
祝賀所有的進步。
There seems to be a broader debate on the role emerging earlier-stage competition in the obesity market could play where that fits in the market broadly.
關於肥胖市場中新興的早期競爭在廣泛適合市場的情況下可能發揮的作用,似乎存在更廣泛的爭論。
I'm sure you're not surprised by the breadth of agents being developed in the space.
我相信您對該領域正在開發的代理的廣度並不感到驚訝。
But just interested in your latest views in terms of barriers to entry you see for some of these newer competitors and how you think about defending Lilly's market position over time?
但只是對您對這些新競爭對手的進入障礙的最新看法感興趣,以及您如何考慮隨著時間的推移捍衛禮來公司的市場地位?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Dan, do you want to start on that?
丹,你想開始嗎?
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Yes, I'll start some R&D comments on barriers to entry.
是的,我將開始一些關於進入障礙的研發評論。
The first, I think, is having a successful drug in Phase III clinical trials and getting it approved.
我認為,第一個是在 III 期臨床試驗中獲得成功的藥物並獲得批准。
You can see that we've invested thoroughly, I would say, in our Phase III portfolio often pursuing multiple indications in multiple populations at once.
我想說,你可以看到我們在我們的 III 期投資組合中進行了徹底的投資,通常同時在多個人群中尋求多種適應症。
Just being able to get to that point, I know investors have gotten excited about various releases of Phase I data.
能夠達到這一點,我知道投資者對第一階段數據的各種發布感到興奮。
But it's still a challenging space to develop drugs and we usually wait until we've seen pretty robust Phase II data before we get too excited about a particular molecule.
但藥物開發仍然是一個充滿挑戰的領域,我們通常會等到看到相當可靠的第二期數據後才會對某個特定分子過於興奮。
So that's the first thing.
這是第一件事。
And I think a lot of the news we've seen from different companies will probably sort out as we get to see Phase II data and which molecules make it and which have the right profile and which don't.
我認為,當我們看到第二階段的資料以及哪些分子製造它、哪些具有正確的特徵、哪些不具有正確的特徵時,我們從不同公司看到的許多新聞可能會得到澄清。
But I wouldn't be expecting 100% success here.
但我並不期望這裡能 100% 成功。
Patrik Jonsson - Executive Vice President, President of Lilly Cardiometabolic Health and President of Lilly USA
Patrik Jonsson - Executive Vice President, President of Lilly Cardiometabolic Health and President of Lilly USA
A few additional comments.
一些補充評論。
I think when we look at the marketplace, there are two very important barriers.
我認為當我們審視市場時,有兩個非常重要的障礙。
We have been extremely successful in gaining access across both Mounjaro, where we are currently 93% access in commercial and 89% in Part D. And similarly, for Zepbound, 86%after 7 months in the marketplace, that's quite significant.
我們非常成功地獲得了Mounjaro 的訪問權,目前我們在商業領域的訪問率為93%,在D 部分的訪問率為89%。訪問率為86%,這非常重要。
The second piece is the amount of outcome indications.
第二部分是結果指示的數量。
We are investing heavily in both Mounjaro and Zepbound, and similarly for the Phase III assets of orforglipron and retatrutide.
我們對 Mounjaro 和 Zepbound 進行了大量投資,對 orforglipron 和 retartrutide 的 III 期資產也進行了類似的投資。
So I think, overall, we think that we are extremely well positioned to compete here.
所以我認為,總的來說,我們認為我們處於非常有利的位置來參與競爭。
And we are not surprised to see that most of the firms are actually leaning into this very important space.
我們毫不驚訝地發現大多數公司實際上都在向這個非常重要的領域傾斜。
But with the cost we have not had in the market today, the Phase III assets and what we referred to in the prepared remarks, we are well positioned to compete today and tomorrow.
但憑藉我們今天市場上沒有的成本、第三期資產以及我們在準備好的評論中提到的內容,我們已經做好了今天和明天的競爭準備。
And that comes across both different indications, assets, length of therapy, et cetera, all hands on deck on our side.
這涉及到不同的適應症、資產、治療時間等等,我們所有人都在努力。
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Maybe one last thing..
也許最後一件事..
But here, we're highlighting our pipeline assets, all different targets.
但在這裡,我們強調我們的管道資產,所有不同的目標。
And maybe just a reminder, Chris, we had our Phase I data for tirzepatide in 2016, that was 8 years ago.
也許只是提醒一下,克里斯,我們在 2016 年獲得了替西帕肽的 I 期數據,那是 8 年前的事了。
And that's a massive lead, I think, over other GIP/GLP agonists that are behind us.
我認為,與我們身後的其他 GIP/GLP 激動劑相比,這是一個巨大的領先優勢。
On the oral side, you can get more in category differentiation based on target engagement, safety profile, et cetera.
在口頭方面,您可以根據目標參與、安全狀況等獲得更多類別差異化。
But here, again, we have the most advanced program, and as Dan highlighted today, a follow-on program to add to that sort of portfolio we have there.
但在這裡,我們再次擁有最先進的計劃,正如丹今天所強調的那樣,這是一個後續計劃,可以添加到我們在那裡的此類投資組合中。
And finally, one other, I don't know if it's barrier, but certainly is work to do is scaling manufacturing.
最後,我不知道這是否是障礙,但肯定要做的工作是擴大製造規模。
The volume is really high in this category, probably will end up being one of the highest volume categories in the history of the industry.
該類別的銷量確實很高,可能最終會成為該行業歷史上銷量最高的類別之一。
And you're talking about making things on the billions scale, which takes time and it's technically difficult and very capital intensive.
你說的是數十億規模的製造,這需要時間,技術上很困難,而且資本密集。
So of course, competitors will come.
所以當然,競爭對手也會來。
But there's a road ahead for all these that the two leading companies have already walked in large part.
但對於所有這些,還有一條路要走,這兩家領先的公司已經在很大程度上走過了。
Operator
Operator
Tim Anderson from Wolfe Research.
沃爾夫研究中心的蒂姆·安德森。
Timothy Anderson - Analyst
Timothy Anderson - Analyst
I have a question on compounders of GLP-1s, including, but not limited to, your tirzepatide.
我有一個關於 GLP-1 複合物的問題,包括但不限於你們的替澤帕肽。
So companies like hims or anyone else.
所以像他或其他人這樣的公司。
How can this not infringe patent protection?
這怎麼可能不侵犯專利保護?
And is this something that is likely to get adjudicated in the courts, meaning that you and presumably Novo, too?
這是否可能會在法庭上得到裁決,這意味著您和 Novo 也可能會受到裁決?
So an article just yesterday in New York Times talked about patients getting upside down with compounded GLP-1s.
因此,昨天《紐約時報》上的一篇文章談到了患者服用複合 GLP-1 後出現倒立的情況。
I think they used the term overdosing on these compounded formulations.
我認為他們在這些複合製劑上使用了“過量”這個術語。
So not only do compounders take away sales from you guys, but it could also âtarnish the reputation of the class.
因此,複合劑不僅會奪走你們的銷售額,而且還會損害班級的聲譽。
So what can we expect Lilly to do about it?
那麼我們可以期待禮來公司對此採取什麼措施呢?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Tim.
謝謝,蒂姆。
Dan, you want to start with some comments?
丹,你想先發表一些評論嗎?
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Yes.
是的。
Thanks for raising this important topic, Tim.
感謝蒂姆提出這個重要的主題。
Of course, we've been watching this carefully, not really out of concern that they're taking away our business.
當然,我們一直在仔細觀察這一情況,並不是真的擔心他們會搶走我們的業務。
As you know, we've been largely supply constrained here, but rather the impact it's having on patient health.
如您所知,我們這裡的供應很大程度上受到限制,但它對患者健康的影響更大。
We often are able to secure samples from these kinds of compounding labs and analyze them in our own labs.
我們通常能夠從此類複合實驗室獲取樣品並在我們自己的實驗室中進行分析。
And what weâve found for the most part, in most instances is this isn't some kind of tirzepatide at all.
我們發現,在大多數情況下,這根本不是某種替澤帕肽。
Our drug is not available to compounders, rather they're purchasing either other chemicals entirely, which we often find or fake producers of tirzepatide that is often full of impurities sometimes contaminated by bacteria.
我們的藥物無法提供給複合商,相反,他們要么完全購買其他化學物質(我們經常發現這些化學物質),要么購買假冒的替西帕肽生產商,這些生產商通常充滿雜質,有時還被細菌污染。
This is a safety risk to patients that we take seriously and are trying to do everything we can to make patients aware of the potential dangers here so that we can help
這對患者來說是一個安全風險,我們認真對待,並正在盡一切努力讓患者意識到這裡的潛在危險,以便我們能夠提供幫助
.
。
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Yes.
是的。
And just from a policy standpoint, I mean, you can expect us to be active here.
我的意思是,僅從政策角度來看,您可以期待我們在這裡表現活躍。
We've taken public positions.
我們已經採取了公開立場。
We're obviously engaged with regulators and considering all kinds of legal actions and filed some.
顯然,我們正在與監管機構合作,考慮採取各種法律行動,並已提起一些訴訟。
Of course, compounding is a long-standing practice under the 503A provisions of FDA, which is meant to customize doses for individual patient needs.
當然,根據 FDA 503A 規定,複方是一種長期存在的做法,旨在根據個別患者的需求量身定制劑量。
It's not clear to me medically what that would be for tirzepatide.
從醫學上我不清楚替澤帕肽的作用是什麼。
But I guess that's legal in a sense.
但我想這在某種意義上是合法的。
It's the mass production that's concerning.
值得關注的是大規模生產。
And we don't see a lot of that with our medicine more with the other one.
我們的藥物中並沒有看到很多這樣的情況,而另一種藥物則沒有看到很多這樣的情況。
But I think if we just step back and reflect on why this is happening, there's shortages because of parenteral manufacturing constraints in the industry and the leading companies.
但我認為,如果我們退後一步思考為什麼會發生這種情況,就會發現由於行業和領先公司的注射劑製造限製而出現短缺。
A lot of that constraint is investing and proving those processes are compliant with the GMP standards that the FDA and Europe under Annex 1 have enforced.
其中很大一部分限制是投資並證明這些流程符合 FDA 和歐洲根據附件 1 強制執行的 GMP 標準。
And we agree, by the way, with that strict enforcement.
順便說一句,我們同意嚴格執行。
So it's a little odd that the answer to that constraint, which is about raising the standards of the industry to a sterile product is to create another industry that is non-sterile product.
因此,對於該限制的答案(即提高無菌產品的行業標準)的答案是創建另一個非無菌產品的行業,這有點奇怪。
So we're just pointing that out.
所以我們只是指出這一點。
And I think you can see Lilly on the front foot here over the coming months to address this.
我認為你可以看到禮來公司在未來幾個月將積極解決這個問題。
But ultimately, the real thing to address is increasing coverage on insurance and increasing supply.
但最終,真正需要解決的是增加保險覆蓋範圍和增加供應。
Weâve made a lot of strides on supply.
我們在供應方面取得了很大進展。
We'll step that up another notch with the availability of vials, and we need to work with primarily the government as well as employers to expand coverage so obesity medicines are affordable.
我們將透過小瓶的供應將這一目標提升到另一個水平,我們需要主要與政府和雇主合作,擴大覆蓋範圍,以便人們能夠負擔得起肥胖藥物。
I think when we get to those points, this will be a non-issue.
我認為當我們達到這些點時,這將不再是問題。
But in the meantime, people can get hurt.
但同時,人們可能會受傷。
And as Dan said, it's pretty concerning what's happening.
正如丹所說,正在發生的事情非常令人擔憂。
Operator
Operator
Umer Raffat from Evercore.
來自 Evercore 的 Umer Raffat。
Umer Raffat - Analyst
Umer Raffat - Analyst
I want to ask on operating leverage, if I may.
如果可以的話,我想問一下經營槓桿。
I know in the first quarter, when you guys raised the guidance by $2 billion on top line, it dropped down to EPS by $1.30. This quarter, guidance went up by $3 billion, but it dropped down at a much higher leverage at $2.16 EPS, almost a 90% incremental margin.
我知道在第一季度,當你們將營收指引提高了 20 億美元時,每股盈餘下降了 1.30 美元。本季度,指引增加了 30 億美元,但在每股收益 2.16 美元的較高槓桿下有所下降,增量利潤率幾乎達到 90%。
And my question is not so much what your operating leverage is going to be in 2025 or a forward year guidance.
我的問題並不是你們 2025 年的營運槓桿或未來一年的指導。
But instead, I'm basically asking if you annualize the momentum of your 4Q numbers per this year's guidance, the EPS upside implied to consensus could be almost as much as half of Lilly's entire full year EPS where it stands right now.
但相反,我基本上是在問,如果您根據今年的指引將第四季度數據的勢頭年化,共識所暗示的每股收益上漲可能幾乎相當於禮來公司目前全年每股收益的一半。
So I'm just trying to think through, how do you plan on spending on various functions and what the incremental margins could look like as the revenue momentum really kicks in with the improving supply?
因此,我只是想思考一下,您計劃如何在各種功能上進行支出,以及隨著供應量的改善,收入動力真正發揮作用,增量利潤會是什麼樣子?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Umer.
謝謝,烏默。
There's a lot of financial mechanics.
有很多金融機制。
So I'll hand to Gordon to comment on, I think, effectively capital allocation considerations.
因此,我認為,我將請戈登評論有效的資本配置考量。
Gordon Brooks - Interim Chief Financial Officer
Gordon Brooks - Interim Chief Financial Officer
Good.
好的。
Thanks.
謝謝。
Appreciate the question.
感謝這個問題。
Yes, I mean, we've been speaking for a long time about operating margins and getting to the mid- to high 30% range.
是的,我的意思是,我們長期以來一直在談論營業利潤率並達到 30% 的中高水平。
As we've seen this year, Mounjaro and Zepbound are taking an inflection point upwards and so we're seeing ourselves at the top end of that range.
正如我們今年所看到的,Mounjaro 和 Zepbound 正在採取向上的拐點,因此我們認為自己處於該範圍的頂端。
For the first half, margins are a little inflated.
上半年,利潤率有點高。
We haven't yet leaned into all of our promotional channels and incretins.
我們還沒有深入研究所有的促銷管道和腸促胰素。
You don't see, for instance, TV commercials on the incretins.
例如,您不會看到有關腸促胰素的電視廣告。
We haven't done that given the supply situation.
考慮到供應情況,我們還沒有這樣做。
And in R&D, it takes time to scale R&D thoughtfully.
在研發方面,需要時間深思熟慮地擴大研發規模。
So it doesn't always move exactly in sync quarter-by-quarter with revenue.
因此,它並不總是與收入按季度完全同步。
That said, our guidance for the year does indicate we will stay in the upper 30% range for the full year, with growth first half, if you look at the first half, as the 2 quarters' growth into the second half.
也就是說,我們對今年的指導確實表明我們全年將保持在 30% 以上的範圍內,上半年會出現增長,如果你看一下上半年,就像下半年兩個季度的增長一樣。
And you should also expect to see within that mix, stronger sales and marketing growth as we get to new launches in the second part of the year and that R&D continues to scale and grow from what we've seen thus far.
隨著我們在今年下半年推出新產品,您還應該期望在這種組合中看到更強勁的銷售和行銷成長,並且研發在我們迄今為止所看到的基礎上繼續擴大和成長。
So those are the dynamics we see on operating margin for 2024.
這些就是我們看到的 2024 年營業利益率的動態。
Operator
Operator
The next question will be from Mohit Bansal from Wells Fargo.
下一個問題將由富國銀行的 Mohit Bansal 提出。
Mohit Bansal - Analyst
Mohit Bansal - Analyst
Congrats on the quarter.
恭喜本季。
My question is regarding the rest of the world sales for incretins.
我的問題是關於世界其他地區腸促胰島素的銷售情況。
It seems like Mounjaro is doing quite well there.
看來Mounjaro 在那裡做得很好。
And if I take out the -- like 15% or so for stocking in the US, it seems like ex-US is already about 33% this early in the launch.
如果我去掉大約 15% 左右的美國庫存,那麼在推出之初,美國以外的庫存似乎已經達到了 33% 左右。
So I would love to understand how has been your experience so far?
所以我很想了解到目前為止您的經驗如何?
And is there going to be any different uptake for ex-US versus your prior generation incretins for both Mounjaro and Zepbound given that these are really efficacious drugs?
考慮到 Mounjaro 和 Zepbound 都是真正有效的藥物,美國前的腸促胰島素和上一代腸促胰島素的吸收率是否會有所不同?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Yes.
是的。
Thanks, Mohit, for the question.
謝謝莫希特提出的問題。
Ilya, do you want to comment on OUS rollout for Mounjaro?
Ilya,您想對 Mounjaro 的 OUS 推出發表評論嗎?
Ilya Yuffa - Executive Vice President, President of Lilly International
Ilya Yuffa - Executive Vice President, President of Lilly International
Sure.
當然。
Thanks, Mohit, for the question.
謝謝莫希特提出的問題。
We've seen some great progress with the launch of Mounjaro outside of the US I think what you've seen in terms of growth in the earlier launch countries, such as the UK, UAE and Saudi, UAE and Saudi are both key markets that make up rest of world, have already achieved a leading share and continue to drive momentum and overall market growth.
隨著 Mounjaro 在美國以外地區的推出,我們看到了一些巨大的進展,我認為您所看到的早期發布國家的增長情況,例如英國、阿聯酋和沙特,阿聯酋和沙特都是關鍵市場,與世界其他地區相比,已經取得了領先的份額,並繼續推動動力和整體市場成長。
And so as you take a look at Q2, the main driver of that growth has been in Mounjaro in markets where we've already launched earlier in the cycle and majority of that coming from the Kwikpen presentation with a lot of that in the UAE.
因此,當你看第二季度時,成長的主要驅動力是 Mounjaro,我們已經在周期的早期推出了這些市場,其中大部分來自 Kwikpen 演示,其中許多來自阿聯酋。
Some of that is channel dynamics similar to the US.
其中一些是與美國類似的通路動態。
At the same time, if you take a look at Q2 and the trajectory for Q2 relative to historical peak sales of any of our brands, has already surpassed that with a limited number of markets where we've launched.
同時,如果你看一下第二季度,你會發現第二季度相對於我們任何品牌的歷史高峰銷售的軌跡,已經超過了我們推出的有限市場的軌跡。
And so as we look at the coming quarters, obviously, we just recently launched in Germany and now also Spain with the Kwikpen presentation.
因此,當我們展望未來幾個季度時,顯然,我們最近剛在德國推出了 Kwikpen 演示,現在也在西班牙推出了 Kwikpen 演示。
We'll also look and monitor the demand and also supply capacity and expect to launch in new markets.
我們還將關注和監控需求和供應能力,並預計在新市場推出。
The near-term growth, I would expect predominantly coming from already launched markets of Mounjaro.
我預期近期成長主要來自 Mounjaro 已經推出的市場。
Operator
Operator
Alex Hammond from Bank of America.
美國銀行的亞歷克斯·哈蒙德。
Alex Hammond - Analyst
Alex Hammond - Analyst
In the prepared remarks, Dan mentioned engagement with regulatory authorities on a potential pivotal trial in MASH.
在準備好的發言中,Dan 提到與監管機構就 MASH 的一項潛在關鍵試驗進行接觸。
Can you provide any color on these discussions and how Lilly is thinking about tirzepatide versus retatrutide for this indication?
您能否提供有關這些討論的任何資訊以及禮來公司如何考慮替澤帕肽與瑞他魯肽治療該適應症?
When could we receive updates?
我們什麼時候可以收到更新?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Dan?
擔?
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Yes.
是的。
Thanks for the question.
謝謝你的提問。
We're really excited about the opportunity to help patients suffering from MASH.
我們非常高興有機會幫助患有 MASH 的患者。
I think the data that we shared in Phase II for tirzepatide is really quite profound in terms of the size of effect we can have.
我認為我們在替西帕肽第二階段分享的數據對於我們可以產生的效果來說確實非常深刻。
There's a couple of issues in mass drug development that we're trying to tackle, probably the most significant of which is current standard of liver biopsy to identify the patients to enroll in these trials and also then measure the outcome.
我們正在努力解決大規模藥物開發中的幾個問題,其中最重要的可能是目前的肝臟活檢標準,以確定參加這些試驗的患者,然後測量結果。
Liver biopsy is obviously an invasive procedure and difficult to find patients to consent to these trials and of course, there's risk to patients.
肝臟切片檢查顯然是一種侵入性手術,很難找到同意這些試驗的患者,當然,患者也存在風險。
We're working hard to develop noninvasive biomarkers that can be used to identify the right patients to enroll in mass studies and also potentially could be used as an outcome to know if a drug is working.
我們正在努力開發非侵入性生物標記物,這些標誌物可用於識別合適的患者參與大規模研究,也有可能用作了解藥物是否有效的結果。
My hope is that we could develop those kinds of biomarkers that could be used both purposes and could be suitable for accelerated approval of mass drugs in the future.
我的希望是,我們能夠開發出既能用於這兩種用途,又能適合未來加速批准大規模藥物的生物標記。
Of course, long-term traditional approval for MASH drugs still requires demonstration of outcomes.
當然,MASH 藥物的長期傳統批准仍然需要結果證明。
So in that environment, we have two drugs that I think could both be great MASH drugs and we'll have to decide whether to invest in one or both of those drugs, depending on the regulatory path we see.
因此,在這種環境下,我們有兩種藥物,我認為它們都可能是很棒的 MASH 藥物,我們必須根據我們看到的監管路徑來決定是否投資其中一種或兩種藥物。
We'll keep investors updated as we make decisions about these molecules in MASH.
當我們對 MASH 中的這些分子做出決定時,我們將隨時向投資者通報最新情況。
Operator
Operator
Evan Seigerman from BMO Capital Markets.
BMO 資本市場部的 Evan Seigerman。
Evan Seigerman - Analyst
Evan Seigerman - Analyst
I wanted to touch on manufacturing and specifically, on the concern that you raised back in February around the proposed acquisition of Catalent by Novo Holdings and the subsequent sale to Novo Nordisk.
我想談談製造業,特別是您在 2 月提出的有關 Novo Holdings 擬收購 Catalent 以及隨後出售給 Novo Nordisk 的擔憂。
Are you still as concerned as you were in February?
你還像二月那樣擔心嗎?
Or given what you've been able to do with your own footprint?
或者考慮到您已經能夠用自己的足跡做些什麼?
Is this less of an issue?
這不是一個小問題嗎?
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Yes, I can take it.
是的,我可以接受。
We remain concerned about that transaction.
我們仍然對該交易感到擔憂。
I don't think it was ever really about the trajectory of our ramp, although as we've disclosed, we do rely on one of the Catalent sites for GLP-1 and other diabetes production.
我認為這與我們的產能成長軌跡無關,儘管正如我們所揭露的,我們確實依賴康泰倫特工廠之一來生產 GLP-1 和其他糖尿病產品。
It's more the oddity of your main competitor being also your contract manufacturer and how to resolve that situation.
更奇怪的是,你的主要競爭對手同時也是你的合約製造商,以及如何解決這種情況。
There's also an industry structure issue.
還有一個產業結構問題。
CDMOs are important for managing capacity across the sector.
CDMO 對於管理整個產業的能力非常重要。
And if we ended up in an outcome where that sector didn't really exist, they all became captive of large pharma would really constrain, I think, availability in the development of medicines, particularly out of biotech.
如果我們最終得出的結果是該部門並不真正存在,那麼它們都將成為大型製藥公司的俘虜,我認為,這將真正限制藥物開發的可用性,特別是生物技術藥物的開發。
So we've aired those concerns publicly and privately since the proposed transaction was announced, and we're waiting to see what happens.
因此,自從擬議的交易宣布以來,我們已經公開和私下表達了這些擔憂,我們正在等待看看會發生什麼。
But in terms of the long-term outlook for our company, as you may have noticed, we're building aggressively ourselves.
但就我們公司的長期前景而言,正如您可能已經注意到的,我們正在積極建立自己。
Our primary strategy is self-run sites.
我們的主要策略是自營網站。
And we've got $18 billion we've announced in the last several years, probably not done there.
過去幾年我們宣布了 180 億美元,但可能還沒完成。
And we're quite comfortable building operating sites and as the newest large sites have begun to come online, we know we can execute that drill and repeat it, and that's our base plan.
我們對建造營運站點感到非常滿意,隨著最新的大型站點已經開始上線,我們知道我們可以執行該演習並重複它,這就是我們的基本計劃。
Operator
Operator
Dave Risinger from Leerink.
來自 Leerink 的 Dave Risinger。
David Risinger - Analyst
David Risinger - Analyst
Let me add my congrats on the results as well and the corporate updates.
讓我對結果和公司更新表示祝賀。
So Zepbound's breadth of health and work or productivity benefits seem to be underappreciated by many.
因此,許多人似乎低估了 Zepbound 在健康、工作或生產力方面的廣泛益處。
There are articles from time to time, let's say, that patients need an off-ramp from therapy, et cetera.
時不時會有一些文章說,患者需要退出治療,等等。
And my question is, what is Lilly doing to encourage patients to stay persistent with therapy?
我的問題是,禮來公司正在採取哪些措施來鼓勵病人堅持治療?
And how does Lilly intend to better communicate not just Zepbound's health benefits, but its worker productivity benefits to employers in order to drive much greater employer inclusion of obesity drugs as part of employee benefits?
禮來公司打算如何更好地向雇主傳達 Zepbound 的健康益處以及其對工人生產力的益處,以推動雇主更多地將肥胖藥物納入員工福利的一部分?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Dave.
謝謝,戴夫。
Patrik, do you want to comment on persistency and benefits?
Patrik,您想對持久性和好處發表評論嗎?
Patrik Jonsson - Executive Vice President, President of Lilly Cardiometabolic Health and President of Lilly USA
Patrik Jonsson - Executive Vice President, President of Lilly Cardiometabolic Health and President of Lilly USA
Absolutely.
絕對地。
I think first overall, when we look at persistency, it's very early after the launch.
我認為首先,當我們考慮持久性時,現在還處於發布後的早期階段。
But based on the feedback we have from providers, and from patients as well, this is a drug that patients want to stay on because they experience the benefits firsthand of weight loss and also the downstream implications on comorbidities.
但根據我們從提供者和患者那裡得到的回饋,患者希望繼續使用這種藥物,因為他們親身體驗了減肥的好處以及對合併症的下游影響。
You're right, the employee opt-in efforts are extremely key, and we believe that our outcome data, OSA, now have HFpEF will help us tremendously and more readout to come over the coming years.
你是對的,員工選擇加入的努力非常關鍵,我們相信我們的結果數據 OSA 現在有 HFpEF,將為我們提供巨大幫助,並在未來幾年提供更多讀數。
We're also having value-based agreement with several other payers where we are looking into the benefits of tirzepatide in the workplace in terms of reduced absentees, increased productivity, et cetera, as well and that has gained a lot of interest.
我們還與其他幾個付款人達成了基於價值的協議,我們正在研究替西帕肽在工作場所的好處,包括減少缺勤、提高生產力等,這引起了許多人的興趣。
In terms of the consumer, yes, the ease to start and stay on is a key priority for us.
就消費者而言,是的,輕鬆開始和堅持是我們的首要任務。
And then we're working with consumer, improving our consumer platforms and also digital channels to really enable patients to experience the benefits that Zepbound provides over time.
然後我們正在與消費者合作,改進我們的消費者平台和數位管道,以真正讓患者體驗到 Zepbound 隨著時間的推移所帶來的好處。
Operator
Operator
Kerry Holford from Berenberg.
來自貝倫貝格的凱瑞·霍爾福德。
Kerry Holford - Analyst
Kerry Holford - Analyst
Just coming back to the margin question earlier, given another expense in the 2024 --
回到先前的保證金問題,考慮到 2024 年的另一項支出——
Operator
Operator
Apologies team.
道歉團隊。
We will get Kerry reconnected with a better line momentarily.
我們將立即為克里提供更好的線路重新連接。
And we'll move on to the next question, in the meantime, if that's okay from Chris Shibutani from Goldman Sachs.
同時,如果高盛的 Chris Shibutani 同意的話,我們將繼續討論下一個問題。
Chris Shibutani - Analyst
Chris Shibutani - Analyst
With all the different oral mechanisms in particular, variations on it from yourselves as well as competitors, can you update us on your thinking on what the basis of competition is going to be?
特別是由於所有不同的口頭機制,您自己以及競爭對手的不同,您能否向我們介紹您對競爭基礎的最新想法?
And what kind of opportunities do you really envision?
您真正設想的機會是什麼?
I think there has been for a while now a comparison on the basis of percent weight loss, particularly for the injectables.
我認為基於減肥百分比的比較已經有一段時間了,特別是對於注射劑。
But as we move into orals, it seems as if tolerability profiles really matter.
但當我們進入口頭階段時,耐受性似乎真的很重要。
So how are you thinking about it?
那你覺得怎麼樣?
And how do you recommend investors think when we compare datasets across these other oral products in development?
當我們比較正在開發的其他口服產品的資料集時,您建議投資人如何思考?
Even if the mechanisms are different, how do we get smarter about differentiating and interpreting data.
即使機制不同,我們如何更聰明地區分和解釋數據。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Dan, you want to chime in?
丹,你想插話嗎?
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Yes.
是的。
Thanks.
謝謝。
I'll start, and then we'll see Patrik to anything to add on commercial differentiation.
我先開始,然後我們會看到派崔克做任何事情來增加商業差異化。
But on the clinical trials, I think first of all, as I said before, just take some caution on the small short Phase I trials.
但在臨床試驗方面,我認為首先,正如我之前所說,對小型短期一期試驗要謹慎一些。
There's more to see.
還有更多值得一看的東西。
Most of the drugs that we've seen actually aren't different mechanisms that are GLP-1 agonists.
我們所見過的大多數藥物實際上與 GLP-1 激動劑的作用機制並沒有什麼不同。
In this class, I don't expect there to be differentiation in terms of efficacy, weight loss.
在這個課程中,我不認為在功效、減肥方面會有差異。
You can pretty much dial in the amount of weight loss you want depending on how aggressively you dose it and what population.
你幾乎可以根據你的減重力度和人群來調整你想要的減肥量。
Tolerability is another issue that usually comes along with the efficacy.
耐受性是通常伴隨療效而來的另一個問題。
The faster you ramp to higher doses, the less tolerability you have.
增加劑量的速度越快,耐受性就越差。
Then the different companies have to work through their own escalation of dosing to match the desired efficacy with some reasonable tolerability.
然後,不同的公司必須透過自己的劑量升級來使所需的療效與合理的耐受性相匹配。
The variable that links those two things together is often the half-life of the molecule.
將這兩件事連結在一起的變數通常是分子的半衰期。
So shorter half-life molecules will give you bigger peak trough excursions in the pharmacokinetics of the drug.
因此,較短的半衰期分子會為藥物的藥物動力學帶來更大的峰谷偏移。
And we think that's what drives the tolerability issues.
我們認為這就是引發耐受性問題的原因。
So what you want is a long half-life molecule that can be dose escalated more smoothly.
因此,您需要的是半衰期長、劑量可以更平穩地遞增的分子。
So that probably will be the differentiation rather than anything that companies are currently talking about in terms of efficacy.
因此,這可能將是差異化,而不是公司目前在功效方面談論的任何內容。
As I said before, it's a long road from early data to Phase III clinical trials like we have with orforglipron and we can expect some attrition.
正如我之前所說,從早期數據到 III 期臨床試驗(就像我們對 orforglipron 所做的那樣)還有很長的路要走,我們可以預期會出現一些損耗。
I'm pretty excited also about next-generation molecule.
我對下一代分子也非常興奮。
All of these ones that we've been talking about now are GLP-1s and will offer efficacy sort of in the range of injectable semaglutide.
我們現在討論的所有這些藥物都是 GLP-1,並且將提供注射索馬魯肽範圍內的功效。
I think ultimately, we'd like to see drugs that offer efficacy and tolerability that exceeds that things that could combine multiple incretins like tirzepatide does and we are certainly working on orals that could also agonize GIP-1, for example.
我認為最終,我們希望看到藥物的功效和耐受性超過像替澤帕肽那樣組合多種腸促胰島素的藥物,並且我們當然正在研究也可以刺激 GIP-1 的口服藥物。
So exciting progress there and more to come on that in the future for us.
那裡取得了令人興奮的進展,未來我們將取得更多進展。
Patrik Jonsson - Executive Vice President, President of Lilly Cardiometabolic Health and President of Lilly USA
Patrik Jonsson - Executive Vice President, President of Lilly Cardiometabolic Health and President of Lilly USA
Just from a commercial point of view, we are regularly conducting both consumer and provider market research.
僅從商業角度來看,我們定期進行消費者和提供者市場研究。
And when we're looking into the preferences, the true drivers today is still the degree of weight loss and safety and tolerability.
當我們研究偏好時,當今真正的驅動因素仍然是減肥程度、安全性和耐受性。
And when we look at the needs beyond that, it's actually the need of an oral, and an oral with an injectable-like efficacy.
當我們考慮除此之外的需求時,實際上是需要口服劑,並且是具有註射劑功效的口服劑。
So that's probably the need that comes beyond what we're currently serving today and particularly to serve those patients that have a fear of injections.
因此,這可能超出了我們目前所服務的範圍,特別是為那些害怕注射的患者提供服務。
When we look at over aspects, I think what comes beyond that would be the composition of weight loss, lean mass versus fats and durability.
當我們從各個方面來看時,我認為除此之外的是減肥、瘦體重與脂肪以及耐用性的組成。
And I think we are looking into all of those aspects as well.
我認為我們也在研究所有這些方面。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
I know we're running short on time.
我知道我們的時間不多了。
So we'll do our best to kind of compress our answers as we get through as many questions as possible.
因此,當我們解決盡可能多的問題時,我們將盡力壓縮我們的答案。
Operator
Operator
And we have Kerry Holford from Bernberg reconnected.
來自伯恩伯格的克里·霍福德 (Kerry Holford) 重新與我們取得了聯繫。
Kerry Holford - Analyst
Kerry Holford - Analyst
Hopefully, you can hear me better this time around.
希望這次你能聽得更清楚。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Much better.
好多了。
Kerry Holford - Analyst
Kerry Holford - Analyst
Lovely.
迷人的。
My question was on margins.
我的問題是關於邊緣的。
So given you are now landing, expecting to land in that mid- to high 30s range this year, so soon after tirzepatide launches, where can we expect your midterm operating margin to land?
因此,鑑於您現在正在著陸,預計今年將在 30 多歲的範圍內著陸,在替西帕肽上市後不久,我們預計您的中期營業利潤率會下降到哪裡?
Is the margin in the mid-40%, perhaps higher, achievable?
40%左右的利潤率,甚至更高,是否可以實現?
And Dave, I know you previously suggested that an operating margin above 40% is not sustainable from an innovation-focused company.
Dave,我知道您之前曾表示,對於一家專注於創新的公司來說,營業利潤率超過 40% 是不可持續的。
But given your progress so far, I wonder if you've changed your view on that.
但考慮到您迄今為止的進展,我想知道您是否改變了看法。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Gordon, do you want to touch on that briefly?
戈登,你想簡單談談這個嗎?
Gordon Brooks - Interim Chief Financial Officer
Gordon Brooks - Interim Chief Financial Officer
Will do.
會做。
Thanks, Kerry.
謝謝,凱瑞。
I appreciate the question.
我很欣賞這個問題。
Yes.
是的。
I think as we said, like guidance, as I said earlier, we do expect to end in that upper 30s range this year.
我認為,正如我們所說,就像我之前所說的指導一樣,我們確實預計今年的價格將達到 30 多歲的範圍。
There's still a lot at play here.
這裡還有很多事情要做。
Yes, on the top line, we see inflection points on revenue.
是的,在營收方面,我們看到了收入的轉捩點。
But through the first half, you've had an inflated position.
但在上半場,你的部位已經膨脹了。
We haven't yet leaned into any of our promotional channels.
我們還沒有使用任何促銷管道。
That's going to be a dynamic that we lean to more starting in the second half.
這將是我們在下半場開始時更傾向於的動力。
And R&D, we do intend to scale that, and that's not going quarter-by-quarter exactly in line with revenue.
在研發方面,我們確實打算擴大規模,但這並不是逐季度與營收完全一致。
So all of those things are still going to play through.
所以所有這些事情仍然會發生。
I think that said, at this point, we're just talking about 2024.
我認為這就是說,目前我們只是在談論 2024 年。
And when we do guidance for '25, we'll chat about the longer-term picture there.
當我們為 25 年提供指導時,我們將討論那裡的長期前景。
Operator
Operator
The next question will be from Akash Tewari from Jefferie
下一個問題將由 Jefferie 的 Akash Tewari 提出
Akash Tewari - Analyst
Akash Tewari - Analyst
So we're starting to see that myostatins may not be the only way to kind of preserve lean muscle mass.
因此,我們開始發現肌肉生長抑制素可能不是維持瘦肌肉質量的唯一方法。
In particular, it looks like amylin GIP/GLP combos are showing the potential for maybe 90% versus 10% fat versus muscle loss.
特別是,胰島澱粉樣多肽 GIP/GLP 組合似乎顯示出可能分別減少 90% 和 10% 的脂肪和肌肉。
Can you talk about what you think eloralintide/tirzepatide combo could show both in terms of absolute weight loss, but also the quality of that weight loss?
您能否談談您認為埃洛林肽/替澤帕肽組合在絕對減肥方面以及減肥品質方面的表現?
And then where would myostatins fit in a world where next-gen amylin triplets could show that level of muscle preservation?
那麼,在下一代胰淀素三聯體可以顯示出這種肌肉保存水平的世界中,肌肉生長抑制素將處於什麼位置?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Dan can focus on that first question about eloralintide.
Dan 可以專注於關於 eloralintide 的第一個問題。
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
So we have multiple mechanisms in play here, starting maybe with the amylin.
因此,我們有多種機制在發揮作用,也許從胰淀素開始。
We have a molecule in Phase II called eloralintide, which is a pure amylin agonist, and we're evaluating that both as monotherapy and in combination with tirzepatide GIP/GLP.
我們有一種處於 II 期階段的分子,稱為 eloralintide,它是一種純胰淀素激動劑,我們正在評估其作為單一療法以及與替澤帕肽 GIP/GLP 的聯合療法。
So that will be interesting to see.
所以這將會很有趣。
I don't have a strong preconceived notions about what to expect in terms of lean versus fat mass loss with that particular combination.
對於這種特定組合的瘦肉量與脂肪量的減少效果,我沒有強烈的先入為主的觀念。
Probably the people who have the most data about that would be the scientists at Novo since they've investigated cagrilintide in combination with semaglutide.
擁有最多這方面數據的人可能是 Novo 的科學家,因為他們研究了卡格林肽與索馬魯肽的組合。
I think that brings us probably to another mechanism, which is dual amylin calcitonin agonism, which cagrilintide probably is a dual agonist, and we have a molecule like that in Phase I called DACRA and we'll also investigate that and composition of biomass will be one of the aspects in which we evaluate it.
我認為這可能給我們帶來了另一種機制,即雙胰島澱粉樣多肽降鈣素激動劑,卡格林肽可能是一種雙重激動劑,我們在第一階段有一個類似的分子,稱為DACRA,我們也將研究它,生物量的組成將是我們評估它的方面之一。
And then finally, you talk of myostatin, we have a molecule in this family, and that's bimagrumab that we acquired from Versantis, which is an â antibody and that's proceeding in a Phase II trial in combination with semaglutide.
最後,說到肌肉生長抑制素,我們在這個家族中有一個分子,那就是我們從 Versantis 獲得的 bimagrumab,它是一種 α 抗體,正在與 semaglutide 聯合進行 II 期試驗。
And we look forward to having data to share with that in the future.
我們期待將來能夠分享數據。
All of these mechanisms, I think, could have variable effects on body mass composition.
我認為,所有這些機制都可能對體重組成產生不同的影響。
I point out that so far, we've not seen any disadvantages to the types of weight loss that we get with tirzepatide.
我指出,到目前為止,我們還沒有看到使用替澤帕肽的減肥類型有任何缺點。
In fact, patients show improved functional outcomes on a variety of things, including improved function in heart failures we just demonstrated.
事實上,患者在許多方面都表現出功能改善,包括我們剛剛證明的心臟衰竭功能的改善。
So could we have further improvements with even more higher ratio of fat to lean mass?
那我們是否可以進一步改進,提高脂肪與瘦肉的比例?
That's the question of these trials.
這就是這些試驗的問題。
Operator
Operator
Trung Huynh from UBS.
瑞銀 (UBS) 的 Trung Huynh。
Trung Huynh - Analyst
Trung Huynh - Analyst
Just following on from the previous question on ex-US GLP-1.
緊接著上一個關於前美國 GLP-1 的問題。
You saw Mounjaro ex-US sales this quarter jumped to $677 million from $286 million.
您會看到 Mounjaro 本季美國以外的銷售額從 2.86 億美元躍升至 6.77 億美元。
Can you give us some color on how ex-US reimbursement is going with the bigger countries?
能為我們介紹一下美國以外的大國的報銷情況嗎?
And is this more of an out-of-pocket drug in these countries?
在這些國家,這更像是一種自付費用的藥物嗎?
And what percentage of the $677 million is obesity sales versus diabetes?
肥胖症銷售額與糖尿病銷售額在 6.77 億美元中所佔的比例是多少?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Okay.
好的。
On that second one, I don't think we'll probably give much of a good answer on that.
關於第二個問題,我認為我們可能不會給出很好的答案。
So I'll maybe ask Ilya to weigh in just on that first question around how ex-US reimbursement is going.
因此,我可能會請伊利亞(Ilya)參與討論第一個問題,即美國以外的報銷情況如何。
Ilya Yuffa - Executive Vice President, President of Lilly International
Ilya Yuffa - Executive Vice President, President of Lilly International
Sure.
當然。
Well, of course, I think the momentum overall is progressing quite nicely in both the reimbursed as well as the out-of-pocket segments.
嗯,當然,我認為報銷和自付費用領域的整體動能都進展得相當不錯。
We have achieved reimbursement in the UK, we have reimbursement in Germany, and we're continuing to look for reimbursement and expand reimbursement in other markets that we've launched.
我們已經在英國實現了報銷,在德國也實現了報銷,並且我們正在繼續尋求報銷並擴大我們已推出的其他市場的報銷範圍。
We have some reimbursement in UAE in Saudi as well in type 2 diabetes.
我們在阿聯酋、沙烏地阿拉伯以及第 2 型糖尿病方面都有一些報銷。
And we continue to expand on that in the markets that we will enter.
我們將繼續在我們將進入的市場中擴展這一點。
But a lot of that momentum is covering both the Type 2 and chronically management market and both in the reimbursed and out-of-pocket segment, and we're seeing both the progress in share as well as market expansion in the markets that we've been in.
但這種勢頭很大程度上涵蓋了 2 類和長期管理市場以及報銷和自付費用領域,我們看到了我們所涉市場的份額的進步以及市場的擴張。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks, Ilya.
謝謝,伊利亞。
Paul, I know we have a lot in the queue.
保羅,我知道我們有很多人在排隊。
Maybe weâll just have two more questions and then wrap things up.
也許我們再問兩個問題,然後就結束了。
Operator
Operator
Steve Scala from TD Cowen.
TD Cowen 的 Steve Scala。
Stephen Scala - Analyst
Stephen Scala - Analyst
The FDA definition of shortage seems clear and tirzepatide no longer meeting the definition of shortage seems to imply Lilly is meeting demand.
FDA 對短缺的定義似乎很明確,替西帕肽不再滿足短缺的定義似乎意味著禮來正在滿足需求。
I assume you will say that that's not the case, but the definition at least in black and white is quite clear.
我想你會說事實並非如此,但至少白紙黑字的定義是相當清楚的。
I assume this is FDA's determination.
我認為這是 FDA 的決定。
So does Lilly agree with FDA's conclusion?
那麼禮來公司是否同意FDA的結論呢?
How is demand being met?
需求如何被滿足?
How is demand being measured?
如何衡量需求?
And what does demand look like?
需求是什麼樣的?
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Yes.
是的。
Thanks for the important question.
謝謝你提出這個重要的問題。
As we think about the compounding question itâs important as well.
當我們思考複合問題時,它也很重要。
As we've said earlier, we're available in all dosage forms in the US.
正如我們之前所說,我們在美國提供所有劑型。
What that means is, as you know, we can fill orders as theyâre received versus what we're doing.
如您所知,這意味著我們可以在收到訂單時立即履行訂單,而不是我們正在做的事情。
That does not mean that any pharmacy or certainly every pharmacy has all 12 dosage forms sitting on their shelf.
這並不意味著任何藥房或每個藥房的貨架上都有所有 12 種劑型。
That's infeasible economically probably for a lot of them and even logistically.
對他們中的許多人來說,這在經濟上甚至在後勤上可能都是不可行的。
So I think we'll continue to see because there's not an abundance of supply, it's more of a real-time fulfillment situation, patients going to pharmacy counters and being told to wait a few days while their orders are filled.
因此,我認為我們將繼續看到,因為供應並不充足,更多的是實時履行情況,患者前往藥房櫃檯並被告知要等待幾天才能完成訂單。
But product is flowing and it's flowing at a pretty high rate.
但產品正在流動,流動速度相當高。
We're shipping quite a bit, and you can see that in these results from the quarter.
我們的出貨量相當大,您可以在本季的結果中看到這一點。
So vials will add to that picture, but demand will increase as well.
因此,小瓶將增加這種情況,但需求也會增加。
So I think we're doing well given the situation.
所以我認為考慮到目前的情況我們做得很好。
But the end pharmacy experience will continue to be choppy.
但最終的藥房體驗將繼續不穩定。
We point that out to the FDA.
我們向 FDA 指出了這一點。
So that means people may call and say, I couldn't get what I wanted on the moment I wanted it at the pharmacy I choose to.
因此,這意味著人們可能會打電話說,我無法在我選擇的藥房買到我想要的東西。
That's not the definition that we think applies here.
我們認為這不是適用於此的定義。
So we'll continue to work with channel partners and the agency to try to clear up the confusion and improve the consumer experience, which is our responsibility along with theirs.
因此,我們將繼續與通路合作夥伴和代理商合作,努力消除混亂並改善消費者體驗,這是我們和他們的責任。
Operator
Operator
Last question today will be from Louise Chen from Cantor.
今天的最後一個問題將由 Cantor 的 Louise Chen 提出。
Louise Chen - Analyst
Louise Chen - Analyst
I wanted to ask you how excited you are about these muscle preserving obesity drugs and if you see that as a true unmet need?
我想問您對這些保持肌肉的肥胖藥物有多興奮,您是否認為這是一個真正未被滿足的需求?
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Thanks.
謝謝。
Dan, anything to add on?
丹,有什麼要補充的嗎?
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Daniel Skovronsky - Executive Vice President, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly Immunology
Yes.
是的。
No, thanks for the question, Louise.
不,謝謝你的提問,路易絲。
I think it's an interesting area of science for sure.
我認為這確實是一個有趣的科學領域。
Too soon to know exactly how these kinds of mechanisms will translate into benefits for patients.
現在確切地知道這些機制將如何轉化為患者的益處還為時過早。
At a high level, we know that the ratio of lean mass to fat mass is really important in determining metabolic health, probably more important as an indicator of overall metabolic health than, for example, BMI.
在較高層面上,我們知道去脂質量與脂肪質量的比率對於確定代謝健康非常重要,作為整體代謝健康的指標可能比 BMI 等更重要。
And so that's what spurs these kinds of efforts to increase lean mass while causing fat mass loss and we'll wait to see data from our own bimagrumab and wait to see how that translates into health benefits for patients.
因此,這就是刺激這些增加瘦體重同時減少脂肪量的努力的原因,我們將等待看到我們自己的 bimagrumab 的數據,並等待看看這如何轉化為患者的健康益處。
Joe Fletcher - Senior Vice President of Investor Relations
Joe Fletcher - Senior Vice President of Investor Relations
Great.
偉大的。
So I think we'll wrap up.
所以我想我們就結束吧。
Dave, closing remarks.
戴夫致閉幕詞。
David Ricks - Charman, CEO & President
David Ricks - Charman, CEO & President
Great.
偉大的。
Thanks, Joe, and thanks to the team here.
謝謝喬,也謝謝這裡的團隊。
We appreciate your participation in today's earnings call and your interest in Eli Lilly and Company.
我們感謝您參加今天的財報電話會議以及您對禮來公司的興趣。
Please follow up with the Investor Relations team if you have any questions we didn't address, and it sounds like there's a few that are holding.
如果您有任何我們未解決的問題,請與投資者關係團隊聯繫,聽起來有一些問題尚未解決。
Happy to answer all of those.
很高興回答所有這些。
Have a great day, everyone.
祝大家有美好的一天。
Operator
Operator
Thank you.
謝謝。
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。
This conference will be made available for replay beginning at 1:00 p.m. today running through September 12 at midnight.
本次會議將於下午 1:00 開始重播。今天持續到 9 月 12 日午夜。
You may access the replay system at any time by dialing 800 3326854 and entering the access code 297484.
您可以隨時撥打800 3326854並輸入訪問碼297484來存取重播系統。
International dollars can call 973 528 0005.
國際美元可致電 973 528 0005。
(Operator Instructions) Thank you for your participation.
(操作說明)感謝您的參與。
You may now disconnect your lines.
現在您可以斷開線路。