2024-04-30 Eli Lilly and Company (LLY) Q1 2024 Earnings Call Transcript

Eli Lilly and Company (NYSE:LLY) Q1 2024 Earnings Conference Call April 30, 2024 10:00 AM ET

Eli Lilly and Company (NYSE: LLY) 2024 年第一季度收益电话会议 2024 年 4 月 30 日上午 10:00 美东时间

Company Participants 公司参与者

Joe Fletcher – Senior Vice President-Investor Relations

乔·弗莱彻 - 高级副总裁-投资者关系

Dave Ricks – Chief Executive Officer

戴夫·里克斯 - 首席执行官

Anat Ashkenazi – Chief Financial Officer

Anat Ashkenazi - 首席财务官

Dan Skovronsky – Chief Scientific Officer and President-Lilly Immunology

Dan Skovronsky - 首席科学官兼总裁-礼来免疫学

Anne White – President-Lilly Neuroscience

安妮·怀特 - 莉莉神经科总裁

Jake Van Naarden – President-Loxo

杰克·范纳登 - 总裁 - Loxo

Patrik Jonsson – President-Lilly Diabetes and Obesity and Lilly USA

帕特里克·约翰逊 - 莉莉糖尿病和肥胖事业部总裁，莉莉美国公司

Conference Call Participants

电话会议参与者

Chris Schott – JPMorgan 克里斯·施特 - 摩根大通

Mohit Bansal – Wells Fargo

莫希特·班萨尔 - 富国银行

Umer Raffat – Evercore

乌默·拉法特 - 美银证券

Seamus Fernandez – Guggenheim

西莫斯·费尔南德斯 - 古根海姆

Tim Anderson – Wolfe Research

蒂姆·安德森 - 沃尔夫研究

Terence Flynn – Morgan Stanley

特伦斯·弗林 - 摩根士丹利

Akash Tewari – Jefferies

阿卡什·泰瓦里 - 杰弗里斯

Trung Huynh – UBS

Trung Huynh - 瑞银 UBS

Geoff Meacham – Bank of America

杰夫·米查姆 - 美国银行

Kerry Holford – Berenberg

Kerry Holford - Berenberg

Steve Scala – TD Cowen

史蒂夫·斯卡拉 - TD Cowen

Evan Seigerman – BMO Capital Markets

伊万·塞格曼 - BMO 资本市场

David Risinger – Leerink Partners

大卫·赖辛格 - 利灵克合伙人

Louise Chen – Cantor

陈露易 - 卡恩特

Chris Shibutani – Goldman Sachs

克里斯·渋谷 - 高盛

Carter Gould – Barclays

卡特·古尔德 - 巴克莱

Kripa Devarakonda – Truist Securities

Kripa Devarakonda - Truist Securities

James Shin – Deutsche Bank

詹姆斯·辛 - 德意志银行

Operator 操作员

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q1 2024 Earnings Call. At this time all participants are in a listen-only mode. Later we will be conducting a question-and-answer session and instructions will be given at that time. [Operator Instructions]

女士们，先生们，感谢您的耐心等候，欢迎参加礼来 2024 年第一季度收益电话会议。此时所有参与者均处于听取模式。稍后我们将进行问答环节，届时将提供说明。【操作员说明】

I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead.

我现在想把会议交给您的主持人 Joe Fletcher，投资者关系高级副总裁。请开始。

Joe Fletcher 乔·弗莱彻

Thank you, Paul, and good morning everyone. Thank you for joining us for Eli Lilly and Company's Q1 2024 earnings call. I'm Joe Fletcher, Senior Vice President of Investor Relations. And joining me on today's call are Dave Ricks, Lilly's Chair and CEO; Anat Ashkenazi, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology; Anne White, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly International; Jake Van Naarden, President of Loxo at Lilly; and Patrik Jonsson, President of Lilly Diabetes and Obesity and Lilly USA. We're also joined by Michaela Irons, Mike Springnether and Lauren Zierki of the IR team.

谢谢，保罗，大家早上好。感谢您参加艾礼莉公司 2024 年第一季度收益电话会议。我是投资者关系高级副总裁乔·弗莱彻。今天与我一起参加电话会议的有莉莉公司董事长兼首席执行官戴夫·里克斯；首席财务官阿纳特·阿什肯纳兹；首席科学官兼莉莉免疫学总裁丹·斯科夫龙斯基博士；莉莉神经科学总裁安妮·怀特；莉莉国际总裁伊利亚·尤法；莉莉旗下洛克索总裁杰克·范纳登；以及莉莉糖尿病与肥胖事业部总裁及莉莉美国总裁帕特里克·约翰逊。我们还有投资者关系团队的迈克拉·艾恩斯、迈克·斯普林内瑟和劳伦·齐尔基。

During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Actual results could differ materially due to several factors, including those listed on Slide 2. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note our commentary will focus on our non-GAAP financial measures.

在这次电话会议中，我们预计会根据我们目前的预期进行预测和前瞻性声明。实际结果可能会因多种因素而有实质性差异，包括幻灯片 2 中列出的因素。有关可能导致实际结果有实质性差异的因素的额外信息包含在我们最新的 10-K 表格和随后向 SEC 提交的文件中。我们提供关于我们的产品和管道的信息是为了投资界的利益。这并非旨在推广，也不足以作出处方决定。在我们转入准备好的讲话时，请注意我们的评论将侧重于我们的非通用会计准则财务指标。

Now I'll turn the call over to Dave

现在我将把电话转给戴夫

Dave Ricks 戴夫·里克斯

Okay. Thanks, Joe. We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses. Our focus is to bring innovative medicines to people in need. And in 2024, we're investing in our people, our launches, expanding our pipeline of new medicines, including through business development, and of course accelerating the needed capacity in our manufacturing network. Results this quarter represent a continuation of the strong growth we delivered in 2023.

好的。谢谢，乔。我们对我们的第一季度业绩和业务持续的势头感到满意，这使我们在今年的发展中处于良好的增长位置。我们的重点是为有需要的人们带来创新药物。在 2024 年，我们将投资于我们的员工、我们的产品推出、扩大我们的新药品管线，包括通过业务发展，并当然加速我们制造网络中所需的产能。本季度的业绩代表了我们在 2023 年取得的强劲增长的延续。

On Slide 4, you can see details of the financial performance and progress related to our strategic deliverables. Revenue grew 26% in Q1 with our new products growing nearly $1.8 billion compared with the same period last year. We achieved several key pipeline milestones, including the positive Phase 3 results for tirzepatide in moderate-to-severe obstructive sleep apnea, the approval of our multi-dose KwikPen delivery device for Mounjaro in Europe, submission of mirikizumab in the U.S. and in EU for moderately to severely active Crohn's disease, the resubmission of lebrikizumab in the U.S. for moderate-to-severe atopic dermatitis and the initiation of our Phase 3 study for lepodisiran, evaluating efficacy and reducing cardiovascular risk.

在幻灯片 4 上，您可以看到与我们战略交付相关的财务表现和进展的详细信息。第一季度收入增长了 26%，我们的新产品与去年同期相比增长了近 18 亿美元。我们实现了几个关键的管道里程碑，包括在中度至重度梗阻性睡眠呼吸暂停症中的 tirzepatide 第 3 期积极结果，我们在欧洲 Mounjaro 的多剂 KwikPen 输送装置获批，美国和欧盟提交 mirikizumab 用于中度至重度活动性克罗恩病，美国重新提交 lebrikizumab 用于中度至重度特应性皮炎，以及我们启动的 lepodisiran 第 3 期研究，评估疗效并降低心血管风险。

Lilly's top priority is to ensure we execute on our ambitious manufacturing expansion agenda. We recently signed an agreement to acquire an injectable medicine facility from Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin. This state-of-the-art facility has been FDA approved, and we are targeting to initiate production at the end of 2025. We broke ground earlier this month on our previously announced parenteral manufacturing site in Germany. And in existing facilities, we are working to maximize output and productivity to meet demand.

Lilly 的首要任务是确保我们执行雄心勃勃的制造扩张议程。我们最近签署了一项协议，从威斯康星州普莱森特普雷里的 Nexus Pharmaceuticals 收购注射药物设施。这家先进的设施已获得 FDA 批准，我们计划在 2025 年底开始生产。本月早些时候，我们在德国先前宣布的无菌制造基地动工。在现有设施中，我们正在努力最大化产量和生产率以满足需求。

The recent EMA approval and upcoming launch of our multi-dose KwikPen delivery life for Mounjaro will unlock new supply capacity for Europe and other international markets while we are also seeing meaningful progress in the ramp of new lines in existing Lilly and CDMO sites for the United States. We continue to make progress against our plans to increase manufacturing capacity, the most ambitious expansion plan in our company's history. Lastly, we distributed over $1 billion in dividends during the first quarter. On Slide 5, you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates.

最近 EMA 批准并即将推出的我们的 Mounjaro 多剂量 KwikPen 交付生命将为欧洲和其他国际市场释放新的供应能力，同时我们也看到现有 Lilly 和 CDMO 站点在美国新线路的逐步进展。我们继续按照增加制造能力的计划取得进展，这是我们公司历史上最雄心勃勃的扩张计划。最后，我们在第一季度分发了超过 10 亿美元的股息。在第 5 张幻灯片上，您将看到自我们 Q4 收益电话以来的关键事件列表，包括我之前提到的里程碑以及其他几个重要更新。

So now let me turn the call over to Anat to review our Q1 financial results.

现在让我把电话交给 Anat，他将回顾我们的 Q1 财务业绩。

Anat Ashkenazi 阿纳特·阿什肯纳齐

Thanks, Dave. Slide 6 summarizes financial performance in the first quarter of 2024. First quarter revenue growth of 26% was driven by new products, primarily Mounjaro and Zepbound. Gross margin as a percent of revenue increased from 78.4% in Q1 2023 to 82.5% in Q1 2024. Gross margin in the quarter benefited from higher realized prices, variable product mix and, to a lesser extent, improved production costs. Marketing, selling and administrative expenses increased 12% primarily driven by promotional efforts supporting current and future launches as well as increased compensation and benefit costs. R&D expenses increased 27%, driven by higher development expenses for late-stage assets, and additional investments in early-stage research, as well as a one-time charge of approximately $75 million associated with the termination of the Verzenio prostate program.

谢谢，戴夫。第 6 张幻灯片总结了 2024 年第一季度的财务表现。第一季度收入增长 26%，主要受到新产品 Mounjaro 和 Zepbound 的推动。毛利率占收入的比例从 2023 年第一季度的 78.4%增加到 2024 年第一季度的 82.5%。本季度的毛利率受益于更高的实现价格、可变产品组合，以及在较小程度上改善的生产成本。市场营销、销售和行政费用增加了 12%，主要是由于支持当前和未来推出的促销活动以及增加的薪酬和福利成本。研发费用增加了 27%，主要是由于晚期资产的开发费用增加，以及对早期研究的额外投资，以及与终止 Verzenio 前列腺项目相关的约 7500 万美元的一次性费用。

In Q1, we recognized acquired IPR&D charge of $111 million, which negatively impacted EPS by $0.10. Operating income increased 63% in Q1 driven by higher revenue from new products, partially offset by operating expense growth. Our Q1 effective tax rate was 11.9% compared to 12.8% in Q1 2023 driven by a larger net discrete tax benefit reflected in Q1 2024 compared with the same period in 2023. We delivered earnings per share of $2.58 in Q1, a 59% increase compared to Q1 2023, inclusive of the negative impact of $0.10 from acquired IPR&D charges in both periods.

在第一季度，我们确认了 1.11 亿美元的收购后无形资产研发费用，对每股收益造成了 0.10 美元的负面影响。第一季度，由新产品收入增加推动，营业收入增长了 63%，部分抵消了营业费用的增长。我们第一季度的有效税率为 11.9%，而 2023 年第一季度为 12.8%，这是由于 2024 年第一季度反映出的净离散税收益比 2023 年同期更大。我们在第一季度实现了每股收益 2.58 美元，较 2023 年第一季度增长了 59%，包括在两个时期中每股收益中 1.11 美元的收购后无形资产研发费用的负面影响。

On Slide 7, we quantify the effect of price, rate and volume on revenue growth. U.S. revenue increased 28% in Q1 driven by growth of Mounjaro, Zepbound and Verzenio. Unprecedented demand for our incretin medicines led to wholesaler backorders of Trulicity, Mounjaro and Zepbound at quarter end. Realized prices in the U.S. increased 16%, largely driven by Mounjaro access and savings card dynamics. Moving to Europe. Revenue growth was once again strong, increasing 29% in constant currency, driven primarily by volume from Verzenio and Mounjaro as well as payments associated with the distribution of divestiture agreement.

在幻灯片 7 中，我们量化了价格、费率和销量对收入增长的影响。美国收入在第一季度增长了 28%，主要受到 Mounjaro、Zepbound 和 Verzenio 增长的推动。对我们胰岛素类药物的需求空前增长，导致托利匹、Mounjaro 和 Zepbound 在季末出现批发商订货不足的情况。美国的实现价格增长了 16%，主要受到 Mounjaro 准入和储蓄卡动态的推动。转向欧洲。收入增长再次强劲，按恒定汇率计算增长了 29%，主要受到 Verzenio 和 Mounjaro 的销量以及与剥离协议分配相关的支付的推动。

Japan revenue grew 2% in constant currency. Volume growth of 7% was driven by Mounjaro and Verzenio, partially offset by decreased volume for Trulicity and a partnership milestone in the base period. Price declined 5% in the quarter.

日本收入在恒定货币下增长了 2%。 7%的销量增长主要由 Mounjaro 和 Verzenio 推动，部分抵消了 Trulicity 的销量下降以及基期中的合作里程碑。本季度价格下降了 5%。

Moving to China, Q1 revenue increased 4% in constant currency. Volume growth was driven by Tyvyt, partially offset by Olumiant and Cialis.

搬到中国后，Q1 营收在恒定货币下增长了 4%。销量增长主要由特维特推动，部分被欧路曼和威而鋼抵消。

Revenue in the rest of the world increased 31% in constant currency, primarily driven by volume growth from Mounjaro and to a lesser extent, Verzenio and Jardiance.

全球其他地区的收入以恒定货币计算增长了 31%，主要受到 Mounjaro 的销量增长以及在较小程度上受到 Verzenio 和 Jardiance 的推动。

Slide 8 provides additional perspective across our product categories. First, I would like to highlight Verzenio, which saw worldwide sales increased 40% in Q1, driven by continued volume growth in the early breast cancer indication. Jaypirca revenue increased to $50 million worldwide, representing an acceleration in sequential quarterly growth following the December 2023 approval for the CLO indication. We are looking forward to potentially making this medicine available to even more patients as future Phase 3 trials read out.

幻灯片 8 提供了我们产品类别的额外视角。首先，我想强调 Verzenio，在 Q1 全球销售增长了 40%，这是由早期乳腺癌适应症持续增长的销量推动的。Jaypirca 的收入在全球增加到 5000 万美元，代表着在 2023 年 12 月获得 CLO 适应症批准后，顺序季度增长加速。我们期待着未来第 3 期试验结果出来后，有可能让更多患者获得这种药物。

Next in Q1, Mounjaro sales were $1.8 billion globally, and $1.5 billion in the U.S., up from $568 million and $536 million in Q1 2023, respectively. Sequential quarter-over-quarter revenue for Mounjaro in the U.S. was impacted by a onetime benefit from changes in estimates for rebates and discounts in Q4 2023 as well as lower inventory in the channel in Q4 2024 amidst strong demand. Access level across commercial end parties were consistent with high levels as we communicated on our last earnings call and near parity with established injectable incretin medicines.

在 Q1 季度，蒙加罗全球销售额为 18 亿美元，在美国为 15 亿美元，分别较 2023 年 Q1 的 5.68 亿美元和 5.36 亿美元有所增长。蒙加罗在美国的季度环比收入受到 2023 年 Q4 估价折扣和折扣变更的一次性利益以及 2024 年 Q4 渠道库存减少的影响，尽管需求强劲。商业终端方面的访问水平与我们在上次盈利电话会议上所传达的高水平一致，并接近已建立的注射剂胰高血糖素药物。

The demand for tirzepatide is very strong. And each week, hundreds of thousands of people fill scripts from Mounjaro and Zepbound yet we understand the frustration from those facing prescription delays or uncertainties yet in their medicine. While we are working tirelessly to ramp supply and expect meaningful increases in shipment volumes in the second half of the year, demand continues to outstrip even increased supply.

对提泽帕肽的需求非常强劲。每周有数十万人从蒙贾罗和泽普邦得到处方，但我们理解那些面临处方延迟或不确定性的人的挫折。虽然我们正在不懈努力增加供应，并预计下半年装运量将有显著增加，但需求仍然超过了即使是增加后的供应。

We remain on track to meet expectations we set earlier this year. The production of salable doses of incretin medicine in the second half of 2024 will be at least 1.5 times the salable doses in the second half of 2023. In the short to midterm, we expect sales growth to primarily be a function of the quantities we can produce and ship.

我们仍然按照今年早些时候设定的预期目标稳步前进。2024 年下半年可销售的胰高血糖素药物剂量将至少是 2023 年下半年的 1.5 倍。在短期到中期，我们预计销售增长主要取决于我们能够生产和发货的数量。

Outside the U.S., we are delighted that the multi-dose KwikPen delivery device from Mounjaro was recently approved in the EU, adding to the UK approval earlier this year. This approval applies to both Type 2 diabetes and product week management indications as they are under the single brand in Europe. While timing for launch will vary by country, we expect to start launching in the EU in coming weeks.

在美国之外，我们很高兴地宣布，Mounjaro 的多剂量 KwikPen 输送装置最近在欧盟获得批准，这是继今年早些时候获得英国批准之后的又一好消息。这一批准适用于欧洲单一品牌下的 2 型糖尿病和产品周管理指示。虽然各国的推出时间会有所不同，但我们预计将在未来几周内开始在欧盟推出。

In Q1, worldwide Trulicity revenue declined 26%. U.S. Trulicity revenue decreased 30% driven by lower volume, primarily due to supply constraints and competitive dynamics. In addition, sales in international markets were impacted by measures we have taken to minimize disruption to existing patients, including communicated to health care professionals to not start new patients on Trulicity.

在第一季度，特路利普全球收入下降了 26%。美国特路利普收入下降了 30%，主要是由于供应限制和竞争动态导致的销量下降。此外，国际市场的销售受到我们采取的措施的影响，以减少对现有患者的干扰，包括向医疗专业人员传达不要让新患者开始使用特路利普。

Turning to Slide 9, we have seen exceptionally strong U.S. launch progress for Zepbound with over $0.5 billion in sales in Q1. We are rapidly building out access for Zepbound in the U.S. And as of April 1, we have approximately 67% access in the commercial segment. As a reminder, patients within this market is a two-step process typically require individual employers to opt in to an anti-obesity medicine rider following PBM coverage. We are continuing to focus on broadening access, both with PBMs and for employer opt-ins and early progress is encouraging.

转到第 9 页，我们看到 Zepbound 在美国的推出进展非常强劲，在第一季度销售额超过 50 亿美元。我们正在迅速扩大 Zepbound 在美国的使用范围。截至 4 月 1 日，我们在商业领域大约有 67%的使用范围。提醒一下，这个市场内的患者通常需要进行两步流程，首先是个别雇主选择加入抗肥胖药物计划，然后是 PBM 覆盖。我们继续专注于扩大使用范围，与 PBM 和雇主选择加入进行合作，初步进展令人鼓舞。

On Slide 10, we provide an update on capital allocation.

在幻灯片 10 上，我们提供了资本配置的更新。

Slide 11 shows updated 2024 financial guidance. Given the strength we're seeing in our business and projections for continued acceleration expected in the second half of the year, we are increasing our full year revenue outlook by $2 billion on the top and bottom ends of the range to be between $42.4 billion to $43.6 billion. This increase is primarily due to the strong performance of Mounjaro and Zepbound and greater visibility and confidence into our production extension for the remainder of 2024.

幻灯片 11 显示了更新的 2024 年财务指引。鉴于我们业务的强劲表现以及预计下半年持续加速，我们将全年营收预期的上下限提高 20 亿美元，预计在 424 亿美元至 436 亿美元之间。这一增长主要归因于 Mounjaro 和 Zepbound 的出色表现，以及对 2024 年剩余时间生产延伸的更大可见度和信心。

With this update, year-over-year revenue growth of the company is now expected to be approximately 26% at the midpoint or approximately 35% for the core business, which excludes the impact from global divestitures.

随着这一更新，公司的年度收入增长预计将达到中点约 26％，核心业务预计将达到约 35％，不包括全球剥离的影响。

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 32% to 34% on a reported basis and 33% to 35% on a non-GAAP basis, representing further margin expansion.

鉴于收入指引的更新，我们现在预计毛利率减去运营支出后除以收入的比率将在报告基础上为 32%至 34%，在非通用会计准则基础上为 33%至 35%，代表进一步的利润率扩张。

We are reaffirming guidance for other income and expense and tax rate, which now takes into consideration Q1 results. Based on these updates, and inclusive of Q1 IPR&D charges of $0.10 per share, we now expect EPS to be in the range of $13.05 to $13.55 on a reported basis and $13.50 to $14 on a non-GAAP basis.

我们正在重申其他收入和支出以及税率的指引，现在已考虑了第一季度的结果。根据这些更新，包括每股 0.10 美元的第一季度 IPR&D 费用，我们现在预计每股收益在报告基础上为 13.05 至 13.55 美元，在非通用会计准则基础上为 13.50 至 14 美元。

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

现在我将把电话交给丹，以突出研发方面的进展。

Dan Skovronsky 丹·斯科夫龙斯基

Thanks, Anat. 谢谢，Anat。

Let me start with our exciting announcement from earlier this month. That was a positive Phase 3 results from the SURMOUNT-OSA studies, which evaluated tirzepatide for treatment of adults with obesities and moderate-to-severe obstructive sleep apnea known as OSA. OSA is a sleep-related breathing disorder characterized by complete or partial collapse of the upper airway during sleep. OSA can have serious cardiometabolic complications contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and even Type 2 diabetes.

让我从本月早些时候的令人兴奋的公告开始。这是 SURMOUNT-OSA 研究的积极 3 期结果，该研究评估了替塞帕肽用于治疗患有肥胖和中度至重度阻塞性睡眠呼吸暂停症（OSA）的成年人。OSA 是一种与睡眠有关的呼吸障碍，其特征是在睡眠期间上呼吸道完全或部分塌陷。OSA 可能导致严重的心脏代谢并发症，包括高血压、冠心病、中风、心力衰竭、心房颤动，甚至 2 型糖尿病。

The need is significant. OSA impacts 80 million people in the U.S. with more than 20 million people suffering from moderate-to-severe OSA. We also know that a substantial majority, approximately 70% of people with OSA also live with obesity. While there are pharmaceutical treatments for the excessive daytime sleepiness associated with OSA, tirzepatide could potentially be the first pharmacological treatment for the underlying disease.

需求非常重要。在美国，有 8000 万人受到 OSA 的影响，其中有 2000 万人患有中度至重度 OSA。我们也知道，大约 70%患有 OSA 的人也患有肥胖症。虽然有药物治疗与 OSA 相关的过度日间嗜睡症，但替瑞巴肽有可能成为首个治疗潜在疾病的药物治疗。

As shown on Slide 12, SURMOUNT-OSA was comprised of two separate trials run under one master protocol. Study 1 evaluated tirzepatide in participants not currently on positive airway pressure or PAP therapy. While Study 2 evaluates tirzepatide in patients who had used PAP for at least three months prior to the study and plans to continue PAP therapy during the entire course of the trial. A total of 469 participants were enrolled across these studies. Each study randomized participants to either maximum tolerated dose approved for tirzepatide, which can be 10 milligrams or 15 milligrams or to placebo, and patients were followed on therapy for 52 weeks.

如第 12 张幻灯片所示，SURMOUNT-OSA 由两个独立试验组成，均在一个总体方案下运行。研究 1 评估了不当前接受正压通气或 PAP 治疗的参与者使用替瑞巴肽。而研究 2 评估了在研究前至少三个月使用 PAP 的患者使用替瑞巴肽，并计划在整个试验过程中继续 PAP 治疗。这些研究共招募了 469 名参与者。每项研究将参与者随机分配到替瑞巴肽批准的最大耐受剂量，可为 10 毫克或 15 毫克，或安慰剂，并且患者将在疗程中接受 52 周的随访。

On Slide 13, we show the results of Study 1. For the efficacy estimate on mean Apnea-Hypopnea Index, or AHI, tirzepatide led to a mean reduction of 27.4 events per hour compared to a mean AHI reduction of 4.8 events per hour for placebo. This difference was highly statistically significant. AHI baseline values were 52.9% and AHI was reduced by 55% in the tirzepatide arm. We also saw a mean body weight reduction of 18.1%, which for tirzepatide, consistent with our expectations for this study. This was, of course, also statistically significant versus placebo.

在幻灯片 13 中，我们展示了研究 1 的结果。对于平均睡眠呼吸暂停低通气指数（AHI）的疗效估计，替瑞巴肽导致每小时平均减少 27.4 次事件，而安慰剂组每小时平均 AHI 减少 4.8 次事件。这种差异在统计学上非常显著。AHI 基线值为 52.9%，替瑞巴肽组 AHI 减少了 55%。我们还观察到平均体重减轻了 18.1%，这与我们对该研究的预期一致。当然，这与安慰剂相比也具有统计学意义。

On Slide 14, we show the results of Study 2. In this population for the efficacy estimand, tirzepatide led to a mean AHI reduction of 30.4 events per hour compared to a mean AHI reduction of 6.0 events per hour for placebo. The baseline AHI was 46.1% in the tirzepatide arm and mean AHI reduction was 62.8%. Again, we saw impressive weight loss with a mean body weight reduction of 20.1% from baseline. These results were also all highly statistically significant.

在幻灯片 14 中，我们展示了研究 2 的结果。在这个人群中，对于疗效估计，替瑞普肽使每小时 AHI 平均减少 30.4 次，而安慰剂组每小时 AHI 平均减少 6.0 次。替瑞普肽组的基线 AHI 为 46.1%，平均 AHI 减少为 62.8%。同样，我们观察到令人印象深刻的体重减轻，平均体重减少了基线的 20.1%。这些结果也都具有高度统计学意义。

In both studies, the overall safety profile was similar to previously reported SURMOUNT and SURPASS trials. The most commonly reported adverse events were gastrointestinal related and generally mild-to-moderate in severity, with the most commonly reported gastrointestinal adverse events for patients treated with tirzepatide being diarrhea, nausea, vomiting and constipation.

在这两项研究中，总体安全性与先前报道的 SURMOUNT 和 SURPASS 试验类似。最常见的不良事件是与胃肠相关的，一般为轻度至中度，接受替塞帕肽治疗的患者最常见的胃肠不良事件为腹泻、恶心、呕吐和便秘。

Prior to the study readout, we noted investor questions about what level of weight loss we would see, given several factors that were uniquely combined in the study of tirzepatide. First, the primary aim of the study was not treatment of obesity. Second, that the population was approximately 70% males, in whom weight loss can be harder to achieve with incretin medicines.

在研究结果公布之前，我们注意到投资者对于在提尔塞帕肽研究中会看到多大程度的体重减轻存在疑问，考虑到几个因素在该研究中独特结合。首先，该研究的主要目的并非治疗肥胖。其次，研究人群中大约有 70%为男性，而在男性中使用胰高血糖素类药物减重可能更为困难。

Third, there's a particularly high baseline BMI in this population. And finally, the use of the 10 milligram or 15 milligram maximum tolerated dose approach. We were therefore highly reassured to see weight loss observed across the two studies at 52 weeks was nearly 20% despite this difficult-to-treat population.

第三，这个人群的基线 BMI 特别高。最后，采用 10 毫克或 15 毫克的最大耐受剂量方法。因此，我们对在 52 周内观察到的体重减轻近 20%感到非常放心，尽管这个难治疗的人群。

Consistent with other Phase 3 studies, such as tirzepatide at the 52-week time point, we did not see weight loss plateau. We'll present detailed results of SURMOUNT-OSA during a symposium at ADA on June 21. Additionally, we plan to submit to the FDA and other global regulatory agencies beginning midyear.

与其他 3 期研究一致，例如在 52 周时点的替瑞巴肽，我们没有看到体重减轻停滞。我们将在 6 月 21 日的 ADA 研讨会上展示 SURMOUNT-OSA 的详细结果。此外，我们计划从年中开始向 FDA 和其他全球监管机构提交。

Moving to the other updates across our portfolio. Slide 15 shows select pipeline opportunities as of April 26, and Slide 16 shows potential key events for the year. We're pleased to share that results were positive in QWINT-4, the first Phase 3 study of insulin efsitora alfa, our once-weekly basal insulin. This study evaluated efsitora compared to insulin glargine in adult participants with Type 2 diabetes who are on multiple daily insulin injections.

转向我们投资组合的其他更新。幻灯片 15 显示截至 4 月 26 日的部分管道机会，幻灯片 16 显示本年度的潜在关键事件。我们很高兴地分享，我们一周一次的基础胰岛素 efsitora alfa 的第 3 期研究 QWINT-4 的结果是积极的。该研究评估了 efsitora 与胰岛素 glargine 在接受多次日常胰岛素注射的 2 型糖尿病成年参与者中的比较。

In the coming weeks, we expect to report top line results from QWINT-4 as well as QWINT-2 which is evaluating efsitora compared to degludec in adults with Type 2 diabetes who are naïve to basal insulin. Together, these are the first two of five studies in the efsitora Phase 3 program.

在接下来的几周，我们预计将报告 QWINT-4 和 QWINT-2 的头部结果，QWINT-2 正在评估与 degludec 相比对于基础胰岛素未接受治疗的 2 型糖尿病成年患者的 efsitora。这两项研究是 efsitora 第 3 期项目中的前两项研究。

Additional updates in our late-stage diabetes and obesity pipeline include results of the EMPACT-MI study, showing Jardiance had a 10% relative risk reduction in the primary composite endpoint of time-to-first hospitalization due to heart failure or all-cause mortality versus placebo, which did not reach statistical significance. We've completed enrollment for SURMOUNT-MMO with over 15,000 participants, and for both orforglipron studies in chronic weight management, ATTAIN-1 and ATTAIN-2, which together enrolled 4,500 participants.

我们晚期糖尿病和肥胖管线的额外更新包括 EMPACT-MI 研究的结果，显示 Jardiance 在首次因心力衰竭或全因死亡而住院的主要复合终点上相对风险降低了 10%，而安慰剂组没有达到统计学显著性。我们已完成 SURMOUNT-MMO 的招募，参与者超过 15,000 人，并且对于慢性体重管理的 orforglipron 两项研究 ATTAIN-1 和 ATTAIN-2，共招募了 4,500 名参与者。

Finally, we've now initiated the TRANSCEND Phase 3 program studying retatrutide in Type 2 diabetes. In the cardiovascular disease area, we're excited to have initiated the Phase 3 trial for lepodisiran, the subcutaneous injectable siRNA. This study will evaluate the efficacy in improving cardiovascular outcomes for participants with high lipoprotein(a), who have cardiovascular disease or at a risk of heart attack or stroke.

最后，我们现在已经启动了 TRANSCEND 第 3 阶段项目，研究 2 型糖尿病中的雷他鲁肽。在心血管疾病领域，我们很高兴地启动了利普地西兰的第 3 期试验，这是皮下注射的 siRNA。这项研究将评估对具有高脂蛋白(a)、患有心血管疾病或有心脏病发作或中风风险的参与者改善心血管结果的有效性。

We are evaluating the efficacy of lepodisiran in both secondary and high-risk primary prevention. And we hope this will one day offer health care providers a treatment option for a broad group of patients and increased cardiovascular risk due to high Lp(a) levels. Earlier in our diabetes and obesity pipeline, we've now initiated a Phase 2 monotherapy study evaluating eloralintide, our selective amylin receptor agonist in obesity.

我们正在评估 lepodisiran 在二级和高风险初级预防中的疗效。我们希望有一天这将为健康护理提供者提供一种治疗选择，适用于由于高 Lp(a)水平而增加心血管风险的广泛患者群。在我们的糖尿病和肥胖管道中，我们现在已经启动了一项第 2 期单药研究，评估我们选择性的淀粉样肽受体激动剂 eloralintide 在肥胖症中的疗效。

Turning to oncology. We made the decision to terminate for futility, the Phase 3 CYCLONE-3 trial evaluating Verzenio in metastatic hormone-sensitive prostate cancer, following an interim analysis. This concludes development of Verzenio in prostate cancer following last quarter's announcement that the CYCLONE-2 study did not meet its primary endpoint. In early oncology development, we’ve initiated Phase 1 trials for two new assets. The first is our Nectin-4 ADC, which came from our acquisition of Emergence Therapeutics.

转向肿瘤学。我们决定基于无效性终止第 3 期 CYCLONE-3 试验，该试验评估 Verzenio 在转移性激素敏感性前列腺癌中的应用，随后进行了中期分析。这一决定结束了 Verzenio 在前列腺癌中的开发，此前宣布 CYCLONE-2 研究未达到主要终点。在早期肿瘤学开发中，我们已启动了两项新资产的第 1 期试验。第一项是我们的 Nectin-4 ADC，这是我们收购 Emergence Therapeutics 获得的。

The second is PNT2001, which came from our acquisition of Point Biopharma. We’re encouraged by what we’re seeing in our oncology portfolio and expect 2024 to be particularly productive. Along with the Nectin-4 ADC and PNT2001 start, we expect at least three other new molecules to enter the clinic this year.

第二个是 PNT2001，这是我们收购 Point Biopharma 获得的。我们对我们的肿瘤学组合所看到的情况感到鼓舞，并预计 2024 年将特别富有成效。除了 Nectin-4 ADC 和 PNT2001 的启动，我们预计至少还有其他三种新分子将于今年进入临床试验。

We look forward to sharing more details with the investment community at an oncology-focused investor event hosted by the Lilly Oncology team. This event will take place on the evening of Sunday, June 2 in Chicago in conjunction with the ASCO Annual Meeting and will also be available via webcast. We plan to provide an update on our oncology strategy and pipeline opportunities. Additional details will be available soon regarding this event.

我们期待在由 Lilly 肿瘤学团队主办的一个以肿瘤学为重点的投资者活动中与投资界分享更多细节。此活动将于 6 月 2 日星期日晚在芝加哥与 ASCO 年会同时举行，并将通过网络直播。我们计划就我们的肿瘤学战略和管道机会提供更新。有关此活动的更多细节将很快公布。

Turning to Neuroscience, last month, we announced that the FDA plans to convene a meeting of the peripheral and CNS Drugs Advisory Committee to discuss donanemab in early symptomatic Alzheimer’s disease. We expect the Advisory Committee Meeting will take place in mid-2024, but the exact date will be confirmed when it appears in the Federal Register.

转向神经科学，上个月，我们宣布 FDA 计划召集外周和中枢神经系统药物咨询委员会讨论早期症状性阿尔茨海默病的多纳替单抗。我们预计咨询委员会会议将于 2024 年中期举行，但确切日期将在联邦公报中确认。

We expect the focus to be around the safety and efficacy profile of donanemab, along with unique aspects of the clinical program. We remain confident in donanemab’s potential to offer very meaningful benefits to patients and look forward to addressing the FDA’s questions in this form.

我们预计焦点将集中在多那麦的安全性和有效性特点，以及临床项目的独特方面。我们对多那麦为患者提供非常有意义的益处的潜力保持信心，并期待以这种形式回答 FDA 的问题。

Additionally, we made the decision to discontinue investigation of GBA1, our gene therapy assets in Gaucher disease type 2. Phase studies in Parkinson’s disease and Gaucher disease type 1 are still underway and have not been impacted by this decision.

此外，我们决定停止对 GBA1 的调查，这是我们在高雀病 2 型中的基因治疗资产。帕金森病和高雀病 1 型的临床研究仍在进行中，并不受此决定影响。

Finally, in immunology, we’ve submitted mirikizumab to the FDA and EMA for approval for use in adults with moderately to severely active Crohn’s disease. In the U.S., we’ve resubmitted lebrikizumab’s application to the FDA for moderate to severe atopic dermatitis.

最后，在免疫学领域，我们已向 FDA 和 EMA 提交了 mirikizumab 的申请，用于治疗中度至严重活动性克罗恩病成人。在美国，我们已重新向 FDA 提交了 lebrikizumab 的申请，用于中度至重度特应性皮炎。

This is following a complete response letter based on inspection findings of the third-party manufacturer. As a reminder, the letter stated no concerns with the clinical data package safety or label. We expect regulatory action in the second half of this year. We’re also announcing that in the coming months, we’ll be initiating Phase 3 studies evaluating lebrikizumab in two new indications, chronic rhinosinusitis with nasal polyposis and allergic rhinitis due to perennial allergens.

这是根据第三方制造商的检查结果所发出的完整回复函。作为提醒，该函指出对临床数据包安全性或标签没有任何担忧。我们预计在今年下半年进行监管行动。我们还宣布，在未来几个月，我们将启动第三阶段研究，评估勒布利库单抗在慢性鼻窦炎合并鼻息肉和因全年过敏原引起的过敏性鼻炎中的两个新适应症。

Lebrikizumab will be the first biologic to be evaluated in Phase 3 for allergic rhinitis. We’re optimistic about the potential of lebrikizumab to be an important treatment option in these patient populations as well as in atopic dermatitis. In earlier-stage immunology development, we’ve advanced our CD19 antibody into Phase 2 for multiple sclerosis.

Lebrikizumab 将是第一个在过敏性鼻炎第 3 期评估的生物制剂。我们对 Lebrikizumab 在这些患者群体以及特应性皮炎中成为重要治疗选择的潜力持乐观态度。在较早阶段的免疫学发展中，我们已将 CD19 抗体推进到多发性硬化症的第 2 期。

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

我现在将电话转回戴夫，以便结束讲话。

Dave Ricks 戴夫·里克斯

Okay. Thanks, Dan. Before we go to Q&A, let me briefly sum up the progress in our first quarter. Strong revenue growth in Q1 was driven by our recent product launches, primarily Mounjaro and Zepbound. We expect acceleration in revenue growth through the second half of the year as supply of incretin medicines continues to ramp.

好的。谢谢，丹。在我们进行问答环节之前，让我简要总结一下我们第一季度的进展。Q1 季度强劲的收入增长主要是由我们最近推出的产品 Mounjaro 和 Zepbound 推动的。随着胰高血糖素类药物供应继续增加，我们预计在今年下半年收入增长将加速。

Significant advances in our pipeline include top line data from tirzepatide and SURMOUNT-OSA, approval of the KwikPen delivery device from Mounjaro in the EU, submission mirikizumab and lebrikizumab as well as initiation of lepodisiran, sorry, Phase 3 study, as Dan just mentioned.

我们管线中的重大进展包括 tirzepatide 和 SURMOUNT-OSA 的头条数据，Mounjaro 在欧盟获得 KwikPen 交付设备的批准，mirikizumab 和 lebrikizumab 的提交以及 lepodisiran 的启动，抱歉，第 3 阶段研究，正如 Dan 刚提到的。

We are continuing to invest in recent and upcoming launches, internal and external pipeline development and our manufacturing expansion agenda. This is to sustain our long-term growth outlook.

我们将继续投资于最近和即将推出的产品，内部和外部管道开发以及我们的制造扩张计划。这是为了维持我们的长期增长前景。

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

现在，让我把电话交给乔，主持问答环节。

Joe Fletcher 乔·弗莱彻

Thanks, Dave. We’d like to take questions from as many callers as possible and to conclude our call in a timely manner. So consistent with prior quarters, we’ll respond to one question for callers, so ask that you limit to one question per caller as we’ll end the call at 11:00 a.m. If you have more than one question, you can reenter the queue, and we’ll get your question if time allows. So Paul, please provide instructions for the Q&A session, and we’re ready for our first caller.

谢谢，戴夫。我们希望尽可能多地接受来电者的问题，并及时结束我们的通话。因此，与之前的季度一致，我们将为来电者回答一个问题，请您每位来电者限制提问一个问题，因为我们将在上午 11:00 结束通话。如果您有多个问题，您可以重新进入队列，如果时间允许，我们会回答您的问题。所以保罗，请提供问答环节的说明，我们已准备好接听第一个来电者。

Question-and-Answer Session

问答环节

Operator 操作员

Thank you. At this time, we’ll be conducting a question-and-answer session. [Operator Instructions] And the first question today is coming from Chris Schott from JPMorgan. Chris, your line is live.

谢谢。此时，我们将进行问答环节。【操作员指示】今天的第一个问题来自 JPMorgan 的 Chris Schott。Chris，你的线路已连接。

Chris Schott 克里斯·施特

Great. Thanks so much, and congrats on the progress here. I just had a question, just was hoping you could elaborate a bit more on the capacity dynamics that are leading to the guidance raise today. I specifically just looking for little more color, is this more U.S. or international? And should we read this as more capacity in the system than you expected or just a faster ramp of the new plant and may be the same overall capacity as you exit the year? Thanks so much.

太好了。非常感谢，恭喜这里的进展。我有一个问题，希望您能更详细地解释一下导致今天提高指导的容量动态。我特别想了解更多细节，这更多是美国还是国际的？我们应该把这看作是系统中的容量超出您的预期，还是新工厂的快速启动，可能与您年底退出时的总体容量相同？非常感谢。

Dave Ricks 戴夫·里克斯

Thanks, Chris. I’ll hand over to Anat to talk about the guidance raise.

谢谢，克里斯。我将把话题交给安娜特来谈谈指导提升。

Anat Ashkenazi 阿纳特·阿什肯纳齐

Thanks for the question, Chris. And as we’ve mentioned earlier in the year when we issued guidance, we said that the – we expect capacity and supply to ramp towards the second half of the year, and that’s what we’re seeing. Now as a reminder, we do have quite a large number of nodes across our supply chain that have to come online or ramp capacity.

感谢提问，克里斯。正如我们在年初发布指导时提到的，我们预计产能和供应将在年下半年逐渐增加，这正是我们所看到的。现在提醒一下，我们的供应链中有相当多的节点需要上线或增加产能。

We are, if you look at everything work we have under construction, or ramping up, we have six sites right now between the two sites in North Carolina, a site in Ireland [ph], two sites in Indiana, a site in Germany and then the seventh one that we just purchased, they are all either ramping up or under construction. And there are multiple nodes across that supply chain that have to become operational, which requires approval, et cetera, for three products, depending on which product runs on which line, that are planned throughout the year. Now that we're four months into the year, we have greater visibility into these nodes of capacity and feel more confident. Just as one example, the approval of the KwikPen in Europe that just came in slightly ahead of our expectation gives us additional confidence in our ability to launch KwikPen for patients in Europe. So it is across our sites globally, as well as ramping up capacity with partners or CDMOs, as well as in existing sites where we're making investments to expand where we can, or ramp up capacity so it's across our supply chain. Thanks.

如果您看我们正在建设或加速的所有工作，我们目前在北卡罗来纳州的两个地点之间有六个地点，爱尔兰的一个地点，印第安纳州的两个地点，德国的一个地点，然后我们刚刚购买的第七个地点，它们都在加速或建设中。整个供应链中有多个节点需要投入运营，这需要批准等，针对三种产品，取决于哪种产品在哪条生产线上运行，这些产品计划在全年内推出。现在我们已经进入年度的第四个月，我们对这些产能节点有了更清晰的了解，并感到更有信心。举一个例子，欧洲对 KwikPen 的批准略超出我们的预期，这增加了我们在欧洲为患者推出 KwikPen 的信心。因此，全球各地的我们的地点，以及与合作伙伴或 CDMOs 加速产能，以及在我们正在进行投资以扩大产能或加速产能的现有地点，都涉及到我们的整个供应链。谢谢。

Dave Ricks 戴夫·里克斯

Thanks. Next caller, Paul.

谢谢。下一个来电者，保罗。

Operator 操作员

Thank you. The next question is coming from Mohit Bansal from Wells Fargo. Mohit, your line is live.

谢谢。下一个问题来自富国银行的 Mohit Bansal。Mohit，你的线路已连接。

Mohit Bansal 莫希特·班萨尔

Great. Thank you very much for taking my question and congrats on the progress. I have a question regarding the pricing. So if you look at the script trend, it seems like there was a little bit of adverse relationship in the pricing versus fourth quarter. Can you comment on that? And how should we think about the cadence of price volume over the quarters for the year? Thank you.

非常好。非常感谢您回答我的问题，并祝贺您取得的进展。我有一个关于定价的问题。如果您看脚本趋势，似乎在定价与第四季度之间存在一点逆向关系。您能对此发表评论吗？我们应该如何考虑今年各个季度的价格量节奏？谢谢。

Dave Ricks 戴夫·里克斯

Thanks, Mohit. You didn’t say it, but I assume you’re talking about Mounjaro and Zepbound, I’ll hand over to Patrik to make some commentary on net price.

谢谢，莫希特。你没有说，但我猜你在谈论蒙贾罗和泽普邦德，我会把话题交给帕特里克就净价做一些评论。

Patrik Jonsson 帕特里克·约翰森

Thank you very much, Mohit. When you look at the pricing of Mounjaro, I think it’s important to take into account that in the Q4 earnings, we announced onetime adjustment for Mounjaro in Q4, that was quite significant. So that was a onetime adjustment in the base of Q4.

非常感谢，Mohit。当您查看 Mounjaro 的定价时，我认为重要的是要考虑到在第四季度收益中，我们宣布了 Mounjaro 的一次性调整，在第四季度，这是相当重要的。所以这是第四季度基础上的一次性调整。

When we look forward for the first half of 2024, it’s important to have in mind that we also terminated the $25 saving card 6/30/2023, but patients that were on are grandfather until 6/30/2024. So there would probably be some benefits during the first half of 2024 for Mounjaro. But from the second half of this year, we should expect to see typical pricing headwinds for Mounjaro as well.

当我们展望 2024 年上半年时，重要的是要记住我们也在 2023 年 6 月 30 日终止了 25 美元的储蓄卡，但截至 2024 年 6 月 30 日，仍在使用的患者将继续享有优惠。因此，在 2024 年上半年，Mounjaro 可能会有一些好处。但从今年下半年开始，我们也应该预计 Mounjaro 会面临典型的价格上涨压力。

Dave Ricks 戴夫·里克斯

Thank you. Next question, Paul.

谢谢。下一个问题，保罗。

Operator 操作员

Thanks. The next question is coming from Umer Raffat from Evercore. Umer, your line is live.

谢谢。下一个问题来自 Evercore 的 Umer Raffat。Umer，你可以发言了。

Umer Raffat 乌默·拉法特

Hi guys. Thanks for taking my question. I wanted to focus a quick second on Part D reimbursement dynamics, if I may. And my question is, will tirzepatide be considered differently than a "weight loss drug" to secure Part D reimbursement? And the new indications like sleep apnea, will they considered an applicable drug and not get lumped up as a broad "weight loss drug"? Thank you.

大家好。感谢您回答我的问题。我想要花一点时间专注于第 D 部分的报销动态，如果可以的话。我的问题是，蒂瑞帕肽是否会被视为与“减肥药”不同以获得第 D 部分的报销？新的适应症如睡眠呼吸暂停，它们是否会被视为适用的药物，而不会被归类为广义的“减肥药”？谢谢。

Dave Ricks 戴夫·里克斯

Thanks, Umer. I’ll go to Patrik for that question.

谢谢，乌默。我会去找帕特里克问这个问题。

Patrik Jonsson 帕特里克·约翰森

Thank you very much, Umer. I think with the announcement made by the CMS early April to reimburse comorbidities for obesity based on the SELECT trial, we’re also confident that with the new data that we presented just weeks ago in terms of obstructive sleep apnea, that’s going to be reimbursed in Medicare Part D. And we expect similarly for other comorbidities and the readout of HFpEF, assuming that’s positive and approved and later on with the mobility-mortality outcome study. Still, our true north is really to get the true of a treat and reduce obesity at cost, and we strongly believe it’s not a matter of if, but when. We don’t see it likely to pass in 2024, but it’s still a small likelihood that that’s going to happen.

非常感谢，乌默。我认为随着 CMS 在四月初宣布根据 SELECT 试验对肥胖相关并发症进行报销，我们也相信根据我们几周前提出的关于阻塞性睡眠呼吸暂停的新数据，这将在医疗保险 D 部分得到报销。我们期待其他并发症以及 HFpEF 的结果，假设结果是积极的并获批准，以及后续的流动性-死亡率研究。然而，我们的真正目标是真正治疗和降低肥胖成本，我们坚信这不是一个“是否”的问题，而是“何时”的问题。我们认为 2024 年不太可能通过，但仍有一小部分可能性会发生。

Dave Ricks 戴夫·里克斯

Thanks, Patrik. Next question, Paul.

谢谢，帕特里克。下一个问题，保罗。

Operator 操作员

Thank you. The next question is coming from Seamus Fernandez from Guggenheim. Seamus, your line is live.

谢谢。下一个问题来自高盛的西莫斯·费尔南德斯。西莫斯，你可以发言了。

Seamus Fernandez 西莫斯·费尔南德斯

Great. Thanks for the question. So really just wanted to ask, Dan, as you have assessed the Phase 2 SURMOUNT data in NASH just interested to know how you are thinking about those data and the opportunity for tirzepatide in that setting or perhaps if retatrutide remains the right target molecule to move forward there? We’ve had a lot of speculation around some of the comments from the last quarter and just trying to firm that up and also when we’re likely to see those data, I believe, they’re expected at EASL but if that is possible to confirm. Thanks so much.

很好。感谢提问。我想问的是，丹，您已经评估了 NASH 第 2 期 SURMOUNT 数据，只是想知道您如何看待这些数据以及 tirzepatide 在该领域的机会，或者 retatrutide 是否仍然是继续前进的正确目标分子？我们对上个季度的一些评论进行了很多猜测，现在想要弄清楚，以及我们何时可能看到这些数据，我相信它们预计会在 EASL 公布，如果可能的话请确认。非常感谢。

Dave Ricks 戴夫·里克斯

Dan? 但？

Dan Skovronsky 丹·斯科夫龙斯基

Thanks, Seamus. I’ll start with the last part there. Yes, the abstract was accepted and will be presented at EASL in early June. So that will be the opportunity to see the full NASH package from that Phase 2 trial. Like we said in the last call, really exciting data. We shared some of the top line. I think tirzepatide can have a profound effect on this disease. It’s a Phase 2 trial. Next steps here are to discuss with the FDA what the best path forward could be for tirzepatide.

谢谢，西莫斯。我会从最后一部分开始。是的，摘要已经被接受，并将在 6 月初的 EASL 会议上展示。这将是看到第 2 期试验中完整 NASH 方案的机会。就像我们在上次通话中说的那样，数据真的很令人兴奋。我们分享了一些最重要的信息。我认为替瑞普肽对这种疾病可能会产生深远影响。这是第 2 期试验。接下来的步骤是与 FDA 讨论替瑞普肽的最佳发展路径。

You’re pointing out, though, that we have another choice in retatrutide, which based on biomarker data from earlier studies could also have a profound effect of this disease. That molecule has the addition of glucagon, which is likely to have additional benefits in the liver. So important opportunities ahead and good to have options as we go into these discussions with regulators. I think for MASH, like other obesity-related or metabolic related diseases, Lilly has a pretty broad portfolio, and we’ll just continue to push the science to make the best possible medicines for patients.

您指出，我们在雷他鲁肽方面还有另一种选择，根据早期研究的生物标志物数据，这种分子也可能对这种疾病产生深远影响。该分子添加了胰高血糖素，这可能在肝脏中具有额外的益处。在与监管机构进行讨论时，有重要的机会和选择是很好的。我认为对于 MASH，就像其他与肥胖或代谢相关的疾病一样，礼来拥有相当广泛的产品组合，我们将继续推动科学，为患者提供最佳可能的药物。

Dave Ricks 戴夫·里克斯

Thanks, Dan. Paul, next question.

谢谢，丹。保罗，下一个问题。

Operator 操作员

The next question will be from Tim Anderson from Wolfe Research. Tim, your line is live.

下一个问题将来自 Wolfe Research 的 Tim Anderson。Tim，你可以发言了。

Tim Anderson 蒂姆·安德森

Thank you. You showed a slide, Zepbound has NBRx share market of 57% at end of Q1. That makes it pretty clear that the strongest drug wins. So on that topic, just your latest thinking on upcoming competitor readouts and how they’ll stack up to Zepbound on metrics of weight loss and blood sugar. So specifically, CagriSema from Novo and Amgen’s 133, I know it’s just the best guess, but it’s what we get asked to do. Thank you.

谢谢。您展示了一张幻灯片，Zepbound 在 Q1 结束时拥有 57%的 NBRx 市场份额。这很明显表明最强的药物会获胜。因此，在这个话题上，您对即将发布的竞争对手数据以及它们在减重和血糖指标上与 Zepbound 相比的最新想法是什么。具体来说，来自诺和安进的 CagriSema 以及安进的 133，我知道这只是最好的猜测，但这是我们被要求做的。谢谢。

Dave Ricks 戴夫·里克斯

Thanks, Tim. Okay. I’ll maybe hand it Dan for some comments.

谢谢，蒂姆。好的。也许我会把它交给丹看看。

Dan Skovronsky 丹·斯科夫龙斯基

Yes, sure, Tim. It’s probably more of your job than ours to speculate on competitor readouts but I’ll take a stab at it since you asked.

是的，当然，蒂姆。推测竞争对手的结果可能更多是你的工作，而不是我们的，但既然你问了，我会试一试。

I think on AMG 133, we’ve just seen really a small amount of data. So probably anything is possible and like you will be interested to see their results. Of course, there’s arguments that can be heard about GIP agonism versus antagonism. We’ve placed our bets, and we like the data we got with GIP agonism.

我认为在 AMG 133 上，我们只看到了非常少量的数据。所以可能任何事情都有可能，就像你会对看到他们的结果感兴趣一样。当然，关于 GIP 激动剂与拮抗剂之间的争论是可以听到的。我们已经下了赌注，我们喜欢我们得到的 GIP 激动剂的数据。

On CagriSema, of course, adding more agonism on different pathways on top of GLP-1 is a good idea. That’s what we have with tirzepatide, as a dual agonist. So CagriSema makes sense. And you’ll note that we’ve advanced our amylin agonist to Phase 2.

在 CagriSema 上，当然，除 GLP-1 外在不同途径上增加更多的激动作用是一个好主意。这就是我们用 tirzepatide 作为双重激动剂所做的。所以 CagriSema 是有意义的。您会注意到我们已经将我们的淀粉样激动剂推进到第 2 阶段。

Tirzepatide already is a dual agonist – tirzepatide already a triple agonist. There’s probably more we could do here at Lilly. I think across our portfolio, in Phase 1 and Phase 2, we have nine assets that are marked for diabetes or obesity. Many of them could lead to additive weight loss on top of established mechanisms plus two more in Phase 3, of course. So we have a strong portfolio here I think tirzepatide still has unsurpassed efficacy at weight loss, but we’re preparing for our next generation assets as well.

提尔塞帕肽已经是一种双重激动剂 - 提尔塞帕肽已经是一种三重激动剂。在 Lilly，我们可能还有更多可以做的。我认为在我们的投资组合中，在 1 期和 2 期，我们有九个被标记为糖尿病或肥胖症的资产。其中许多可能会导致在已建立的机制之上的附加减重，当然还有两个在 3 期。因此，我认为我们在这里拥有强大的投资组合，我认为提尔塞帕肽在减重方面仍然具有无与伦比的功效，但我们也在为下一代资产做准备。

Dave Ricks 戴夫·里克斯

Thanks, Dan. Paul, next question.

谢谢，丹。保罗，下一个问题。

Operator 操作员

The next question will be from Terence Flynn from Morgan Stanley. Terence your line is live.

下一个问题将来自摩根士丹利的特伦斯·弗林。特伦斯，您的线路已连接。

Terence Flynn 特伦斯·弗林

Great. Congrats on all the progress. Just was wondering if you can tell us if the IQVIA prescription data is an accurate representation of tirzepatide volumes or if it’s been underrepresented at all given LillyDirect and what you know about how much is flowing through that channel? And if it is underrepresented, can you help quantify any delta for us. Thank you.

太好了。恭喜你们取得的所有进展。我只是想知道，您能否告诉我们 IQVIA 处方数据是否准确地反映了替瑞普肽的销量，或者在考虑到 LillyDirect 以及您对通过该渠道流通的数量的了解后，是否有被低估的情况？如果有被低估的情况，您能帮助我们量化任何差异吗？谢谢。

Dave Ricks 戴夫·里克斯

Thanks for the question, Terence. I’ll hand to Patrik for commentary on IQVIA and LillyDirect.

谢谢您的提问，Terence。我将把话题交给 Patrik，让他就 IQVIA 和 LillyDirect 发表评论。

Patrik Jonsson 帕特里克·约翰森

Thanks very much, Terence. When it comes to LillyDirect, I think we are very pleased with the start. And when we look at the utilization by consumers, it’s gaining traction by weeks here. If we look at the TRx data of Q1, particularly for Zepbound, it’s relatively low volume that goes through LillyDirect, slightly higher in terms of NBRx. It’s our understanding that what goes through LillyDirect is not by default captured by IQVIA. But IQVIA has a methodology in place to estimate what goes through LillyDirect as well.

特伦斯，非常感谢。谈到 LillyDirect，我认为我们对开局非常满意。就消费者的利用情况来看，这里的情况每周都在好转。如果我们看一下 Q1 的 TRx 数据，特别是 Zepbound，通过 LillyDirect 流通的量相对较低，而 NBRx 方面稍高一些。我们了解通过 LillyDirect 的数据不会默认被 IQVIA 捕捉到。但 IQVIA 已经制定了一套方法来估算通过 LillyDirect 的数据。

Dave Ricks 戴夫·里克斯

Thank you, Patrik. Paul, next question.

谢谢，帕特里克。保罗，下一个问题。

Operator 操作员

The next question will be from Akash Tewari from Jefferies. Akash your line is live.

下一个问题将来自 Jefferies 的 Akash Tewari。Akash，请发问。

Akash Tewari 阿卡什·特瓦里

Thanks so much. So your team presented data on a monotherapy GIP agonist at ADA last year, but it looks like you are moving the amylin into Phase 2. Can you talk about why amylin might be preferred versus GIP as a maintenance regimen for obesity? And how your product could defer versus others when it comes to half-life and preferential agonism versus calcitonin and amylin? Thanks.

非常感谢。所以您的团队在去年的 ADA 大会上展示了有关单药物 GIP 激动剂的数据，但看起来您正在将淀粉样蛋白移入第 2 阶段。您能谈谈为什么淀粉样蛋白可能比 GIP 更适合作为肥胖维持治疗方案吗？以及在半衰期和优先激动与降钙素和淀粉样蛋白相比时，您的产品如何有所不同？谢谢。

Dave Ricks 戴夫·里克斯

Thank you, Akash. I’ll hand to Dan for commentary on our amylin.

谢谢，Akash。我会把话题交给丹，让他评论我们的胰淀粉样多肽。

Dan Skovronsky 丹·斯科夫龙斯基

Yes, there are a lot of good questions in there. Thanks for following the science so closely. So on the GIP, the long-acting molecule I think primarily in that experiment, we were excited to show the benefits of isolated GIP agonism, just to answer some mechanism of action questions around tirzepatide. But as you point out, there’s potential for that molecule for other indications or as a monotherapy or combination with other mechanisms.

是的，里面有很多好问题。感谢您如此密切地跟踪科学。关于 GIP，我认为在那个实验中，长效分子主要是激动剂，我们很兴奋地展示了孤立 GIP 激动剂的好处，只是为了回答一些关于 tirzepatide 作用机制的问题。但正如您指出的，该分子在其他适应症或作为单药治疗或与其他机制联合应用方面有潜力。

But of course, since tirzepatide already includes GIP agonism, we’re also excited to explore other mechanisms. So that’s where the [indiscernible] which is one of nine different mechanisms, as I said a moment ago that we’re exploring the long-acting amylin move forward to Phase 2. That has potential perhaps as a combination therapy, perhaps as a maintenance therapy, perhaps as a monotherapy, there’s a lot to explore. It’s still very early as it is for all of our mechanisms. So we’ll keep investing, and as we have data to share, we’ll do that.

当然，由于 tirzepatide 已经包括 GIP 激动作用，我们也很兴奋地探索其他机制。这就是其中的一个[不可辨识]，正如我刚才所说的，我们正在探索长效阿米林进入第 2 阶段的九种不同机制之一。这可能具有作为联合疗法、维持疗法或单独疗法的潜力，有很多可以探索的地方。对于我们所有的机制来说，现在仍然处于非常早期阶段。因此，我们将继续投资，并在有数据分享时分享。

Dave Ricks 戴夫·里克斯

Thanks, Dan. Paul, next question.

谢谢，丹。保罗，下一个问题。

Operator 操作员

The next question will be from Trung Huynh from UBS. Trung, your line is live.

下一个问题将来自瑞银的 Trung Huynh。Trung，您可以发言了。

Trung Huynh

Yes. Hi. Thanks for my question. Just back on CMS recently broadening its coverage for Wegovy for certain heart conditions, I appreciate you mentioned that Teva is the main goal. But do you expect Zepbound to get add to CMS in a similar way as Wegovy? And when could this happen? Could this be after the heart failure data in 3Q? Or do we have to wait for the CVOT data? Thanks very much.

是的。嗨。感谢您回答我的问题。最近 CMS 扩大了 Wegovy 对某些心脏疾病的覆盖范围，我很感激您提到 Teva 是主要目标。但您是否预计 Zepbound 会像 Wegovy 一样被加入 CMS？这可能何时发生？这可能是在第 3 季度心力衰竭数据之后吗？还是我们必须等待 CVOT 数据？非常感谢。

Dave Ricks 戴夫·里克斯

Thanks, Trung. I’ll let Patrik respond.

谢谢，Trung。我会让帕特里克回复。

Patrik Jonsson 帕特里克·约翰森

Thanks, Trung. Now based upon what CMS stated early April, we actually expect to get obstructive sleep apnea for Zepbound covered by CMS and Medicare at the time of launch. And the next one then would be Zepbound assuming a positive readout and approval. And the third one would be the MMO indication that's the sequence of our plans, assuming everything goes according to plan and we get the approval for both.

谢谢，Trung。根据 CMS 四月初的声明，我们实际上期望在 Zepbound 推出时得到 CMS 和 Medicare 对阻塞性睡眠呼吸暂停的覆盖。接下来将是 Zepbound，假设结果为阳性并获批准。第三个将是 MMO 适应症，这是我们计划的顺序，假设一切按计划进行并且我们获得两者的批准。

Joe Fletcher 乔·弗莱彻

Thanks, Patrick. Paul, next question.

谢谢，帕特里克。保罗，下一个问题。

Operator 操作员

The next question will be from Geoff Meacham from Bank of America. Geoff your line is live.

下一个问题将来自美国银行的杰夫·米查姆。杰夫，您的线路已连接。

Geoff Meacham

Good morning guys. Thanks for the question. You guys have been asked on this before, I'm sure, but can you just review the rationale in utilizing the KwikPen just for outside the U.S. markets like you, but I wasn't sure why this couldn't apply to the U.S. market and if this also could be a means to relieve capacity looking forward? Thank you.

早上好，大家。感谢提问。我相信你们以前已经被问过这个问题，但你们能否简要回顾一下只在美国以外市场使用 KwikPen 的理由？我不确定为什么这不能应用于美国市场，这是否也可以成为未来缓解产能的手段？谢谢。

Joe Fletcher 乔·弗莱彻

Thanks, Geoff, for the question. Paul, Dave, you want to weigh in?

谢谢，杰夫，谢谢你的问题。保罗，戴夫，你们想发表意见吗？

Dave Ricks 戴夫·里克斯

Yes. Sure. Anyway [ph], I can add to this. As we think we've said on several calls now, our goal is to pursue all of the above, basically as it relates to supply options, recognizing the tremendous demand and unmet need and the constraints that exist in scaling the supply chain. So KwikPen uses existing assets, so there was less time lag. We see this first in the UK and now in Europe as a way to meet the needs of those patients. But we haven't ruled it out in other jurisdictions. And so we'll continue to look at every option we can to meet the needs of patients with obesity and overweight as well as with diabetes.

是的。当然。无论如何，我可以补充一下。正如我们在几次通话中所说的，我们的目标是追求上述所有内容，基本上与供应选项有关，认识到巨大的需求和未满足的需求，以及在扩大供应链方面存在的限制。因此，KwikPen 使用现有资产，因此时间延迟较少。我们首先在英国看到这一点，现在在欧洲也是为了满足这些患者的需求。但我们并没有排除在其他司法管辖区的可能性。因此，我们将继续寻找我们可以采取的每一种选项，以满足肥胖和超重患者以及糖尿病患者的需求。

Joe Fletcher 乔·弗莱彻

Thanks, Dave. Paul, next question.

谢谢，戴夫。保罗，下一个问题。

Operator 操作员

The next question is from Kerry Holford from Berenberg. Kerry, your line is live.

下一个问题来自 Berenberg 的 Kerry Holford。Kerry，您可以发言了。

Kerry Holford

Hi, I'm going to take a different topic here. Looking Lp(a) your new product, you now said that you're taking into Phase 3. Can you confirm whether you published the Phase 2 data, haven't found any. So if I'm correct, when we might see that published? And can you confirm what dose and frequency of administration you're looking at for that Phase 3 study? And I guess that you appear to be positioned third in that race, would be interested to hear how you expect your drug to be differentiated versus the competitor as already in Phase 3? Thank you.

嗨，我要换个话题。关于您的新产品 Lp(a)，您现在说您已经进入第 3 阶段。您能确认是否已发布第 2 阶段的数据吗？我还没有找到。所以如果我没记错的话，我们什么时候可能会看到那些数据发布？您能确认第 3 阶段研究的剂量和给药频率吗？我猜您似乎在那场竞赛中排名第三，很想知道您预计您的药物与已经进入第 3 阶段的竞争对手有何区别？谢谢。

Dave Ricks 戴夫·里克斯

Thanks, Kerry. So a good multipart question, but on Lp(a), happy to talk about lepodisiran. So Dan, do you want to comment on this?

谢谢，Kerry。这是一个很好的多部分问题，但关于 Lp(a)，很高兴谈谈 lepodisiran。那么，Dan，你想对此发表评论吗？

Dan Skovronsky 丹·斯科夫龙斯基

Yes. Thanks, Kerry, for the good questions here. You're right, we haven't yet published a Phase 2 data. But I think we just recently were able to publish the Phase 1 data. That was really exciting and well received. I think one of the things that people noted in our Phase 1 data was a very long durability of action in the very deep reduction in Lp(a) levels following a single dose of lepodisiran. We now have, of course, a Phase 2 data in hand and use that design and to begin the Phase 3 trial. I think we haven't quite disclosed dose or frequency yet, but I'm sure that will happen in time.

是的。谢谢你的好问题，Kerry。你说得对，我们还没有发布第 2 阶段的数据。但我认为我们最近刚刚能够发布第 1 阶段的数据。那真的很令人兴奋，而且得到了很好的反馗。我认为人们在我们的第 1 阶段数据中注意到的一点是，单剂量 lepodisiran 后作用的持续时间非常长，Lp(a)水平大幅降低。当然，我们现在手头上有第 2 阶段的数据，并利用该设计开始第 3 阶段的试验。我认为我们还没有透露剂量或频率，但我相信那将会在适当的时候公布。

You asked about differentiation. I think there's probably a couple of different potentials for differentiation here versus a shorter-acting ASO into siRNA that are both in Phase 3 studies. Maybe first is the depth of clearance of Lp(a), we don't know how much you have to reduce Lp(a) to lead to benefits in cardiovascular outcomes and whether there's a threshold effect or a floor to this. So the depth of clearance is one.

您问了关于分化的问题。我认为在这里可能有几种不同的分化潜力，与正在进行第 3 阶段研究的短效 ASO 转化为 siRNA 相比。也许首先是 Lp(a)的清除深度，我们不知道需要降低多少 Lp(a)才能带来心血管结果的益处，以及是否存在阈值效应或底线效应。因此，清除深度是一个方面。

The second, as you asked about, could be frequency of administration or durability of action, those two being closely linked. And the third, of course, is the population that's being studied to I noted we're studying secondary as well as primary prevention here. So I think we have a good package with multiple opportunities for differentiation and eager to test the Lp(a) hypothesis here in this Phase 3 study.

正如您所询问的，第二个可能是给药频率或药效持续时间，这两者密切相关。当然，第三个是被研究的人群，我注意到我们这里正在研究二级预防以及初级预防。因此，我认为我们有一个很好的方案，有多种区分机会，并且渴望在这个第三阶段研究中测试 Lp(a)假设。

Joe Fletcher 乔·弗莱彻

Thanks, for the question, Kerry. Paul, next question.

谢谢你的问题，Kerry。保罗，下一个问题。

Operator 操作员

The next question will be from Steve Scala from TD Cowen. Steve, your line is live.

下一个问题将来自 TD Cowen 的 Steve Scala。Steve，您可以发言了。

Steve Scala 史蒂夫·斯卡拉

Thank you very much. Given that based on all available metrics, the SURPASS-CVOT interim likely already has passed, can you confirm that the only way the trial would have stopped is if there were either a survival benefit or futility and not simply non-inferiority? And anything you can say regarding your confidence in eventually hitting superiority based on what you know so far? Thank you.

非常感谢。鉴于根据所有可用指标，SURPASS-CVOT 中期很可能已经过去，您能确认试验停止的唯一方式是是否存在生存益处或无效，而不仅仅是非劣效吗？根据目前所知，您对最终达到优越性的信心有何看法？谢谢。

Joe Fletcher 乔·弗莱彻

Thanks, Steve. Dan, do you want to take the question on SURPASS-CVOT?

谢谢，史蒂夫。丹，你想回答关于 SURPASS-CVOT 的问题吗？

Dan Skovronsky 丹·斯科夫龙斯基

Sure. Thanks, Steve. As you know, we do our best not to comment on interim analysis, although many of our different trials kind of corporate interim analysis. But when we do talk about the risks, unintentional unblinding of results, for that reason, we prefer not to do that. You're right that the primary analysis of the study and the design is around noninferiority versus what we are ready to know to be a very good drug that reduces cardiovascular risk, and that's Trulicity. So it's designed as a noninferiority trial. Of course, when the final data come, we would be delighted to see even superiority.

当然。谢谢，史蒂夫。正如你所知，我们尽力不对中期分析发表评论，尽管我们的许多不同试验都涉及中期分析。但当我们谈论风险时，由于结果的无意识解盲，出于这个原因，我们更倾向于不这样做。你说得对，研究的主要分析和设计是围绕非劣效性与我们准备了解的一种非常有效的降低心血管风险的药物，即 Trulicity。因此，它被设计为一项非劣效性试验。当然，当最终数据出来时，我们会很高兴看到甚至是优越性。

You asked about our confidence. Confidence continues to increase for this readout. In fact, as disclosed in the prepared remarks today, we got additional data here even from the OSA study that should make us feel more confident, not just the benefit of sleep apnea, which itself could lead to cardiovascular benefits, but actually the weight loss. And I think there are some concerns about weight loss of different populations and different trials and males, females, et cetera. So some of that was discharged here. So remain excited and look forward to getting that data when the study is complete.

您询问我们的信心。对于这次读数，信心持续增强。事实上，正如今天的准备好的讲话中披露的那样，我们甚至从 OSA 研究中获得了额外的数据，这应该让我们感到更有信心，不仅仅是睡眠呼吸暂停的好处，这本身可能会带来心血管好处，而实际上是减肥。我认为对于不同人群和不同试验以及男性、女性等的减肥存在一些担忧。所以其中一些内容在这里得到了解决。因此，我们仍然对完成研究并获得数据感到兴奋并期待着。

Joe Fletcher 乔·弗莱彻

Thanks, Dan. Paul, next question?

谢谢，丹。保罗，下一个问题？

Operator 操作员

The next question will be from Evan Seigerman from BMO Capital Markets. Evan, your line is live.

下一个问题将来自 BMO Capital Markets 的 Evan Seigerman。Evan，您可以发言了。

Evan Seigerman 伊万·西格曼

Hi. Thank you so much for taking my question. I wanted to touch on donanemab with the AdCom approaching. Can you discuss how your – if your confidence has changed in the asset? And maybe any specific points that you will hope will be addressed during this discussion with these outside experts. Thank you so much.

您好。非常感谢您回答我的问题。我想谈谈随着 AdCom 的临近，对多那麦单抗的看法。您能谈谈您对这项资产的信心是否有所改变吗？也许您希望在与这些外部专家讨论时提出的任何具体观点。非常感谢。

Dave Ricks 戴夫·里克斯

Thanks, Evan. Anne, you want to discuss with on the AdCom?

谢谢，伊万。安妮，你想和 AdCom 讨论吗？

Anne White 安妮·怀特

Yes. Thanks so much for the question. And we are incredibly confident in donanemab potential and the fact that it offers very meaningful benefits to people with early symptomatic Alzheimer’s disease and just the overall approvability of the package. We do look forward to seeing there’s questions. We haven’t received those yet.

是的。非常感谢您的提问。我们对多那莫的潜力非常有信心，它为早期症状性阿尔茨海默病患者提供了非常有意义的益处，而且整体上也具有可批准性。我们期待看到更多问题。我们还没有收到那些问题。

I think that what we’ll anticipate really is discussions around the safety and efficacy of donanemab and those – the safety and efficacy profile remain very consistent with what we published and presented. So nothing new there. We do expect there’s a couple of unique aspects to our trial that we anticipate they’ll want to discuss. One is around limited duration dosing. We think this is an incredibly important feature of donanemab, the chance to stop dosing when you’ve cleared the plaques and donanemab clears them robustly and rapidly. So, we think that allows for this limited duration dosing approach. So we really do look forward to getting into that data and having the advisors see that and respond to it.

我认为我们真正期待的是围绕多纳替单抗的安全性和有效性进行讨论，而这些 - 安全性和有效性概况与我们发布和展示的内容非常一致。所以没有什么新的内容。我们确实预计我们试验中有一些独特的方面，他们可能会想要讨论。其中之一是关于有限持续给药。我们认为这是多纳替单抗的一个非常重要的特点，即在清除斑块并且多纳替单抗迅速而彻底地清除它们后停止给药的机会。因此，我们认为这允许采用这种有限持续给药的方法。因此，我们真的很期待深入研究这些数据，并让顾问们看到并对其做出回应。

Another unique aspect is assessing tau at baseline. This is important for the field that we understand the prognostic factor of tau, and that was able to be earned. But what we saw in the trial was all patients benefited regardless of tau level with those early in the disease doing even better. It’s one of the reasons that we remain so enthusiastic about TRAILBLAZER 3. And while Dan didn’t mention that in his remarks, I think he remain even more enthusiastic about the opportunity to intervene earlier based on what we saw in that early population, the people with low tau and those that had no tau with such strong biomarker results.

另一个独特的方面是在基线评估 tau。对于我们了解 tau 的预后因素以及能够获得的领域来说，这是很重要的。但在试验中我们看到的是，所有患者都受益，无论 tau 水平如何，早期患病的患者表现得更好。这是我们对 TRAILBLAZER 3 保持如此热情的原因之一。虽然丹在他的讲话中没有提到这一点，但我认为他对根据我们在早期人群中看到的情况更早干预的机会更加热情，即那些 tau 水平较低以及没有 tau 的人，这些人具有如此强大的生物标志结果。

I think you probably remember the data that patients in the earliest part of our study had a 60% slowing. And we believe that could be even stronger as you get into the earlier patients that are preclinical. But maybe just one remark. In the meantime, though, this is not time loss. We’ll continue to make sure the health care system is ready. We’re going to make sure that we launch into an even stronger market with potential approval. So we’re making the most of this time and look forward to the AdCom, [ph] as Dan said, in mid-2024, answering any questions that they have.

我认为你可能还记得我们研究早期患者数据显示减缓了 60%。我们相信随着进入临床前患者，这种效果可能会更强。但也许只是一句话。与此同时，这并不是时间的浪费。我们将继续确保医疗系统做好准备。我们将确保在潜在批准的市场中推出更强大的产品。因此，我们正在充分利用这段时间，并期待着 AdCom，正如丹所说，在 2024 年中期回答任何问题。

Joe Fletcher 乔·弗莱彻

Thank you, Anne. Paul, next question?

谢谢，安妮。保罗，下一个问题？

Operator 操作员

The next question will be from David Risinger from Leerink Partners. David, your line is live.

下一个问题将来自 Leerink Partners 的 David Risinger。David，您可以发言了。

David Risinger 大卫·赖辛格

Thanks very much. And let me add my congrats on the progress and the guidance raise. So my question is on orforglipron. Novo Nordisk has raised some concerns about the scalability of orforglipron manufacturing given its complexity, I haven’t spoken to Novo directly, but someone told me that they mentioned there are 35 steps in the process. I don’t know if that’s true. But could you please discuss how Lilly is building out its manufacturing capacity and whether the company expects to be able to meet global demand in the Western world after launch in 2026? Or whether we, the investment community, should expect supply constraints and should be guarded about how we try to model orforglipron’s ramp after launch? Thank you.

非常感谢。让我再次祝贺您取得的进展和提升的指导。所以我的问题是关于 orforglipron。诺和诺德对 orforglipron 的可扩展性提出了一些担忧，因为其制造过程复杂。我还没有直接与诺和诺德交谈过，但有人告诉我，他们提到这个过程中有 35 个步骤。我不知道这是否属实。但请问您能否讨论一下 Lilly 如何扩大其制造能力，以及公司是否预计在 2026 年推出后能够满足西方世界的全球需求？或者我们，投资界，是否应该预期供应受限，并且在尝试对 orforglipron 的推出后进行建模时应该保持谨慎？谢谢。

Joe Fletcher 乔·弗莱彻

Thanks, Dave. I’ll hand over to Dave Ricks here.

谢谢，戴夫。我将把话筒交给戴夫·里克斯。

Dave Ricks 戴夫·里克斯

Okay. Great. Dave, great to hear from you. I mean, first of all, it is true that our orforglipron is a complicated large, small molecule, a large small molecule, if you were, and there are many steps in the process. You can read about them in our patent filings, I think. But Lilly, maybe unlike other companies, we made small molecules for a long time. We’re capable of doing it. We understand how to put them together, and we’ve got a defined process to do it for orforglipron.

好的。太好了。戴夫，很高兴收到你的来信。首先，我们的奥法格利普隆确实是一个复杂的大分子，一个大分子，如果你愿意这样说的话，整个过程中有许多步骤。你可以在我们的专利申请中了解更多信息，我想。但是，与其他公司可能不同，莉莉公司长期以来一直在制造小分子。我们有能力做到这一点。我们了解如何将它们组合在一起，并且我们有一个明确定义的过程来为奥法格利普隆完成这一过程。

So the API production were a long process and maybe complicated relative to other small molecules is something we’re super confident in and have our arms around. The finish process is really the big advance over using injectables because here, we’re just tablet stamping or tablet – capsule making, which are dry processes, we understand extremely well.

因此，相对于其他小分子，API 生产是一个漫长且可能复杂的过程，但我们对此非常有信心，并已经掌握了要领。完成过程真的是相对于使用注射剂的重大进步，因为在这里，我们只是进行片剂压制或片剂-胶囊制作，这些都是干燥过程，我们非常了解。

I think the big gain here will be the fact that both for synthetic chemistry and capsule making and tablet making, there is already capacity on planet Earth that is significant. And so unlike the parenteral side where we’ve been talking about injectables and new capacity needs to be built, in which we’re doing aggressively as a not [ph] commented on earlier, here, there’s a lot of partners we can access as well as our own substantial network or dry product go finish [ph] and API production. So pretty confident here.

我认为这里的主要收益将在于事实上，对于合成化学、胶囊制造和片剂制造，地球上已经有相当大的产能。因此，与我们一直在谈论需要建立新产能的注射剂一侧不同，我们正在积极进行的是，这里有很多合作伙伴可以利用，以及我们自己庞大的干制品和原料药生产网络。所以在这方面我感到非常有信心。

Now when we stick the landing on exact doses and quantities in every instance? We’re not guaranteeing that, but I think the picture will be quite a bit different should orforglipron prove to be safe and effective in the Phase 3 studies. Again, that’s in 2025, so we can expect launch maybe a year after that, and that’s an important event in the time course of the incretin class.

现在，当我们在每种情况下都精确掌握剂量和数量时，我们并不保证，但我认为如果奥法格列普隆在第 3 阶段研究中被证明是安全有效的，情况将会大不相同。再次强调，这是在 2025 年，所以我们可以预期可能在那之后一年推出，这对于胰高血糖素类药物的时间进程来说是一个重要事件。

Joe Fletcher 乔·弗莱彻

Thanks Dave. And thanks Dave Risinger for the question. Next question, Paul?

谢谢戴夫。感谢戴夫·赖辛格提出的问题。下一个问题，保罗？

Operator 操作员

Next question is coming from Louise Chen from Cantor. Louise, your line is live.

下一个问题来自康泰尔的陈露易。陈露易，你可以发言了。

Louise Chen 陈露易

Hi. Thanks for taking my question. I just wanted to ask you about your next wave of obesity drug. It looks like you're about half a dozen of these in development. And where do you see the most differentiate yourself?

嗨。感谢您回答我的问题。我只是想问问您关于下一波肥胖药物的情况。看起来您正在开发大约六种这样的药物。您认为在哪方面最能突出自己？

Dave Ricks 戴夫·里克斯

Thanks. Dan, do you want to comment on the earlier phase obesity?

谢谢。丹，你想评论一下早期肥胖吗？

Dan Skovronsky 丹·斯科夫龙斯基

Yes. Thanks, Louise. We're excited about the portfolio of earlier-stage obesity molecules. I think there's a number of opportunities for improvement over – even an excellent drug like tirzepatide. We think about the quality of weight loss as one aspect. So for example, even on tirzepatide, we see the ratio of lean to fat mass approved as patients lose weight on these drugs could we make it improve even faster with the muscle stimulating agents like bimagrumab, but maybe that's under investigation.

是的。谢谢，路易丝。我们对早期肥胖分子组合感到兴奋。我认为有许多改进的机会，即使像替瑟帕肽这样的优秀药物也有。我们考虑减重质量作为一个方面。例如，即使在替瑟帕肽上，我们看到瘦肉与脂肪质量的比例在患者在这些药物上减重时也得到批准，我们是否可以通过像比马格鲁莫这样的肌肉刺激剂使其改善得更快，但也许这正在调查中。

Tirzepatide is very well tolerated, but some people stop taking it because of GI side effects. Could we have drugs that have fewer side effects? But maybe that could be possible. Tirzepatide is given as a once a weekly injection, most patients find that to be acceptable, but probably with less frequent injections that could lower the burden on manufacturing and make it easier to use for patients, so that's another avenue of exploration. There are some patients who don't achieve their desired levels of weight loss even on a powerful drug like tirzepatide, and so that's another avenue.

Tirzepatide 非常耐受，但有些人因胃肠道副作用而停止服用。我们能否有更少副作用的药物？也许这是可能的。Tirzepatide 每周注射一次，大多数患者认为这是可以接受的，但可能通过更少的注射次数降低制造负担，并使患者更容易使用，因此这是另一个探索的途径。有些患者即使使用像 tirzepatide 这样的强效药物也无法达到他们期望的减重水平，因此这是另一个途径。

Finally, across different indications, and I spoke earlier of NASH, that are related to metabolic disease. There could be different activities that proved more or less beneficial for these other related diseases. So that's another avenue of differentiation. I think we're just at the beginning of probably what will be seen as a multi-decade investments in treating abnormal metabolism and all diseases that come with that. And I'm really proud and pleased that really has what must be the strongest pipeline in this area in the industry.

最后，在不同的适应症中，我之前提到了与代谢疾病相关的 NASH。对于这些其他相关疾病，可能有不同的活动被证明对其更或更少有益。这是另一种差异化途径。我认为我们可能只是在治疗异常代谢和随之而来的所有疾病方面进行多年投资的开端。我真的为我们在这一领域拥有可能是行业中最强大的产品管线感到自豪和高兴。

Dave Ricks 戴夫·里克斯

Thank you, Dan. Paul, next question.

谢谢，丹。保罗，下一个问题。

Operator 操作员

The next question is from Chris Shibutani from Goldman Sachs. Chris, your line is live.

下一个问题是 Goldman Sachs 的 Chris Shibutani 提出的。Chris，您可以发言了。

Dave Ricks 戴夫·里克斯

Thanks, Chris. Paul, the next question?

谢谢，克里斯。保罗，下一个问题？

Chris Shibutani 克里斯·渋谷

Can you hear me?

你能听到我说话吗？

Dave Ricks 戴夫·里克斯

Yes, there you are. Go ahead, Chris.

是的，你在这里。继续，克里斯。

Chris Shibutani 克里斯·渋谷

Great. Thank you. 好的。谢谢。

Wanted to ask about supply and dynamic and the demand and when those two might come closer together? Previously, not you been quite specific in your vocabulary and saying that that was something that could possibly happen in 2025. Dave, you were in front of a group that we hosted and I think you gave a little bit of a broader range. What's the latest that you would like to communicate based upon all the progress that you're making, the acquisition of Wisconsin facility, et cetera, about a potential timing for that supply-demand dynamic to come closer together?

想问一下关于供应和动态以及需求，以及这两者何时可能会更接近？之前，您在用词方面并不是很具体，并表示这可能会在 2025 年发生。戴夫，您曾在我们举办的一个小组面前发表讲话，我记得您提到了一个更广泛的范围。基于您所取得的所有进展，包括对威斯康星设施的收购等，您最新想要传达的关于供需动态何时可能更接近的时间是什么？

Dave Ricks 戴夫·里克斯

Thanks, Chris. Anat? 谢谢，克里斯。阿纳特？

Anat Ashkenazi 阿纳特·阿什肯纳齐

Yes. Let me start on this. So I would say that, as I said in my prepared remarks, we expect that the supply and demand situation will remain quite tight in the near-term as well as the mid-term. And just to clarify, it's not that we have a production issue or manufacturing facilities are progressing incredibly well, and I'm incredibly proud of the work done by our M&Q colleagues around the world. Clearly, we have sites working 24/7. We're doing construction overnight. We're making the right investments and progressing rapidly as you've seen evidence by the results as well as the raise we did for the year.

是的。让我开始吧。所以我想说的是，正如我在我的准备好的讲话中所说的，我们预计供需状况在短期和中期内仍将保持相当紧张。只是为了澄清，不是我们有生产问题或制造设施进展得非常顺利，我对我们全球 M&Q 同事所做的工作感到非常自豪。显然，我们的工地 24/7 都在运作。我们在夜间进行施工。我们正在进行正确的投资，并且正如您所看到的结果以及我们为今年做出的提高所证明的那样，我们正在迅速进展。

But the demand is strong, but shouldn't be a surprise given the health benefits that these products provide to patients, highly efficacious and safe medicines. And I expect that this will continue through the year, even with the significant ramp that we have and we'll add more supply across different presentations, both with the auto-injector as well as the Kwikpen. But even with that, I expect that the demand will be – will outpace supply through this year, potentially next year, obviously, we'll see. We'll continue to invest and ramp as we go into next year, but it could be quite some time.

但需求强劲，但鉴于这些产品为患者提供的健康益处，这并不令人意外，这些药物高效且安全。我预计这种情况将持续到今年，即使我们已经有了显著的增产，并将在不同的配方中增加更多供应，包括自动注射器和快速注射笔。但即使如此，我预计需求将超过供应，可能持续到今年年底，明年也可能如此，显然，我们将继续投资和增产，但这可能需要相当长的时间。

We talked earlier about orforglipron, should we have positive Phase 3 readout that provides another relief valve in terms of just offering a different presentation, as Dave mentioned, which utilizes a different set of infrastructure within our manufacturing organization available capacity globally. So it will be in a stepwise fashion. We'll continue to update investors as we progress through the year and coming years.

我们之前谈到了 orforglipron，如果我们有积极的第 3 阶段结果，那将提供另一个缓解阀，只是提供一个不同的展示方式，正如戴夫所提到的，利用我们制造组织全球可用产能的不同基础设施。因此，这将是一个分阶段的过程。随着我们在今年和未来几年的进展，我们将继续向投资者更新。

Dave Ricks 戴夫·里克斯

Thanks, Anat. Paul, next question.

谢谢，阿纳特。保罗，下一个问题。

Operator 操作员

Next question will be from Carter Gould from Barclays. Carter, your line is live.

下一个问题将来自巴克莱的卡特·古尔德。卡特，你的线路已连接。

Carter Gould 卡特·古尔德

Great. Thanks. Good morning. Congrats on all progress. I wanted to dive into bimagrumab ahead of the Phase 2b data forthcoming. Can you talk for a bit around the importance of showing statsig or clear dose response across the composition of the weight loss drivers and maybe as well as the importance of not blunting the overall weight loss as you contemplate a move to Phase 3 potentially? Thank you.

太好了。谢谢。早上好。恭喜所有的进展。我想在第 2b 阶段数据即将公布之前深入研究 bimagrumab。您能否谈一下展示统计显著性或明确剂量反应在减重驱动因素组成中的重要性，以及在考虑潜在进入第 3 阶段时不减弱整体减重的重要性？谢谢。

Dave Ricks 戴夫·里克斯

Thanks, Carter, for the question. Dan, you want to comment on the bimagrumab?

谢谢你的问题，卡特。丹，你想评论一下比马格鲁单抗吗？

Dan Skovronsky 丹·斯科夫龙斯基

Yes. Thanks, Carter. It's a good question. Bimagrumab is a very different mechanism of weight loss versus incretins, but one that we think could be important in combination with incretins. So bimagrumab, we think will likely have important effects on adipose tissue as well as muscle mass. And so our hope is to see increased muscle mass and increased ratio, I should say of lean to fat mass by combining bimagrumab with incretins.

是的。谢谢，卡特。这是一个很好的问题。Bimagrumab 是一种与胰高血糖素完全不同的减重机制，但我们认为与胰高血糖素结合可能很重要。因此，我们认为 Bimagrumab 可能对脂肪组织以及肌肉质量产生重要影响。因此，我们希望通过将 Bimagrumab 与胰高血糖素结合，看到肌肉质量增加以及瘦体重与脂肪体重比例增加。

In this present study, it's being evaluated both as monotherapy in combination with semaglutide at different doses. So we'll see if weight loss effects on fat tissue stack, and we'll see if effects on lean body mass that we're seeing in previous bimagrumab monotherapy studies work in combination with incretin. Looking forward to seeing that, too.

在这项研究中，正在评估它作为单药疗法与不同剂量的塞马鲁肽联合使用。因此，我们将看到对脂肪组织堆积的减重效果，以及我们将看到在之前的比马格鲁单药疗法研究中观察到的对瘦体重的影响是否与胰高血糖素联合使用。期待也能看到这一点。

Joe Fletcher 乔·弗莱彻

Thanks Dan. Paul, next question?

谢谢丹。保罗，下一个问题？

Operator 操作员

The next question is coming from Kripa Devarakonda from Truist Securities. Kripa your line is live.

下一个问题来自 Truist Securities 的 Kripa Devarakonda。Kripa，请发问。

Kripa Devarakonda

Hey guys. Thank you much for taking my question and congrats on all the progress. I have a question about your radio pharma pipeline. You mentioned PNT2002 in your oncology pipeline. Can you talk about how you see that advancing? And given what you've seen so far, where you see this being placed in the landscape in terms of market share? Thank you.

嘿，大家。非常感谢您回答我的问题，并祝贺您取得的所有进展。我有一个关于您的放射性药物管线的问题。您在您的肿瘤学管线中提到了 PNT2002。您能谈谈您如何看待它的发展吗？鉴于您目前所见，您认为它在市场份额方面将处于什么位置？谢谢。

Dave Ricks 戴夫·里克斯

Thanks, Kripa, for the question. Jake, calling you to maybe opine a little bit on our radioligand efforts, PNT2001 in particular?

谢谢，Kripa，提出这个问题。Jake，请您对我们的放射配体工作，特别是 PNT2001，发表一点意见吗？

Jake Van Naarden 杰克·范纳登

Yes, happy to. Thanks for the question. We're really excited about bringing radiopharmaceuticals into the portfolio by way of the acquisition of Point Biopharma, and we are supplementing that acquisition with additional work through our Discovery Labs and the ability to make these medicines ourselves. So I expect we'll have more to talk about in terms of additional medicines over the course of the next couple of years in addition to PNT2001.

是的，很高兴。感谢提问。我们对通过收购 Point Biopharma 将放射性药物纳入产品组合感到非常兴奋，我们通过我们的 Discovery Labs 和自己制造这些药物的能力来补充这一收购。因此，我预计在未来几年中，除了 PNT2001 之外，我们将有更多的药物可以讨论。

But specific to that question, 2001 is a PSMA-directed therapy for prostate cancer conjugated to actinium, the altimeter. And I think while the actinium holds a lot of promise over lutetium, particularly in the context of creating double-stranded DNA breaks versus single stranded and the ability to perhaps drive more efficacy for patients for prostate cancer. I think one of the limitations of the existing agents is that they probably cause too much salivary gland toxicity to be real durable products.

但是针对这个问题，2001 年是一种针对前列腺癌的 PSMA 定向疗法，与锕结合，高度计。我认为，虽然锕在创建双链 DNA 断裂方面比钌有很大的潜力，尤其是在为前列腺癌患者创造更多疗效的背景下。我认为现有药物的一个局限性是它们可能导致太多唾液腺毒性，无法成为真正持久的产品。

And so the POINT team designed a novel PSMA-directed ligand with increased tumor uptake relative to the salivary gland in order to drive more therapeutic index using actinium as the payload. So we're just getting started with the Phase 1 experience right now. So I don't have a lot to say about what we're seeing just yet. But the preclinical package looked really interesting and differentiated from the other PSMA ligands that exist out there. So we're looking forward to putting it through its Phase 1 paces, and we'll see what we have.

因此，POINT 团队设计了一种新型的 PSMA 导向配体，相对于唾液腺，肿瘤摄取增加，以利用锕作为荷载物来提高治疗指数。因此，我们现在刚刚开始进行第 1 阶段的实验。所以我现在还没有太多关于我们所看到的东西要说。但是临床前方案看起来非常有趣，并且与其他现有的 PSMA 配体有所区别。因此，我们期待着让其经历第 1 阶段的考验，然后我们将看到我们得到了什么。

Depending on the clinical profile, I think there's the potential to improve outcomes in patients that have already seen a lutetium based agent, maybe go ahead of that and compete with the lutetium based agents or perhaps even go even earlier in therapy as PSMA expression really exists in the continuum of prostate cancer care. So more to come on that as we define the clinical profile in the Phase 1.

根据临床特征，我认为有潜力改善那些已经接受过镥基制剂治疗的患者的预后，也许可以超越镥基制剂并与之竞争，甚至可以更早地在 PSMA 表达真正存在于前列腺癌护理的连续过程中进行治疗。因此，在我们定义第 1 阶段的临床特征时，还有更多内容要讨论。

Dave Ricks 戴夫·里克斯

Thanks, Jake. Paul, I think we've got time for maybe one more question. We're right at 11:00. So maybe a final question in the queue.

谢谢，杰克。保罗，我觉得我们可能还有时间再问一个问题。现在是 11 点整。所以可能还有一个问题在等着。

Operator 操作员

Okay. And the final question today is coming from James Shin from Deutsche Bank. James, your line is live.

好的。今天的最后一个问题来自德意志银行的詹姆斯·辛。詹姆斯，你可以发言了。

James Shin 詹姆斯辛

Hey, good morning guys. Thanks for question. I just wanted to try and reconcile the guidance lift with the 1.5 times sellable doses being maintained. Thank you.

嗨，早上好。谢谢提问。我只是想尝试将指导提升与维持 1.5 倍可售剂量相协调。谢谢。

Dave Ricks 戴夫·里克斯

Okay. James, maybe I'll give Anat to talk about the guidance and how the guidance raised relates to the 1.5 – those comments.

好的。詹姆斯，也许我会让阿纳特谈谈指导以及指导提出的与 1.5 相关的评论。

Anat Ashkenazi 阿纳特·阿什肯纳齐

Yes. So let's start with the 1.5 dose – sellable dose comment that I made on the guidance call in February. So that reference is not a number of devices, but number of sellable doses. And as we ramp up capacity for KwikPen, recall that unlike the single-use vial or the auto-injector, that KwikPen is a multidose device that has multiple dose available for patients.

是的。那么让我们从我在二月份的指引电话中提到的 1.5 剂量-可销售剂量评论开始吧。因此，该参考并非设备数量，而是可销售剂量的数量。随着我们增加 KwikPen 的产能，需要回想的是，与单次使用小瓶或自动注射器不同，KwikPen 是一种多剂量设备，可为患者提供多剂量。

That common [ph] referred to the second half of this year versus the second half of last year. So we're expecting that total sellable doses this year in the second half will be at least 1.5 times where we were second half of last year. That remains unchanged. But the level of confidence we have in our ability to progress on each node of our capacity that's coming online or will get approved, et cetera, has just increased. There are multiple of these throughout the year. Multiple of these have occurred. Some will occur, as I gave the KwikPen as one example.

那个常见的[ph]指的是今年下半年与去年下半年相比。因此，我们预计今年下半年的可销售剂量至少是去年下半年的 1.5 倍。这一点保持不变。但我们对我们在每个节点上的能力取得进展的信心水平已经提高。这一年中有多个这样的情况。这种情况已经发生了多次。一些情况将会发生，比如我提到的 KwikPen。

You think about a construction of a site, for example, Concord in North Carolina, which we said will become operational by end of the year, and we'll start seeing products next year. That construction has concluded. Lines are installed, and we need to run qualifications, get approval, et cetera. There are multiple nodes of these across our own manufacturing sites as well as external and that they all need to come online to get to where we need in terms of the full year guidance. But our confidence as the year progresses, a year has progressed, our confidence in that has increased, but it remains the – at least 1.5 times.

您考虑一个工地的建设，例如，北卡罗来纳州的康科德，我们说将在年底投入运营，并且明年我们将开始看到产品。该建设已经完成。线路已安装，我们需要进行资格认证，获得批准等。我们自己的制造工厂以及外部都有多个这样的节点，它们都需要上线，以达到我们在全年指导方针中所需的目标。但随着一年的进展，我们对此的信心增强了，但仍然至少是 1.5 倍。

Dave Ricks 戴夫·里克斯

Thanks, Anat. Great. Well, thanks for your time today, everyone, and we appreciate you participating in today's earnings call and your interest in our company. Please follow up with the IR team if you have any additional questions that we didn't address today, and have a great day. Thanks.

谢谢，Anat。太好了。感谢大家今天抽出时间参加收益电话会议，我们感谢您对我们公司的关注。如果您有任何今天未解决的问题，请与 IR 团队跟进，祝您有一个美好的一天。谢谢。

Operator 操作员

Thank you. And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00 p.m. today running through June 4 at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 317750. International dialers can call at 973-528-0005. Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 317750. Thank you for your participation. You may now disconnect your lines.

谢谢。女士们先生们，今天的会议到此结束。本次会议将于今天下午 1 点开始重播，持续至 6 月 4 日午夜。您可以随时拨打 800-332-6854 并输入访问代码 317750 来访问重播系统。国际拨打者可致电 973-528-0005。再次提醒，访问代码为 317750 的号码是 800-332-6854 和 973-528-0005。感谢您的参与。您现在可以挂断电话。

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