| 指标 | 2026年第三季度业绩 | 变动或背景 |
|---|---|---|
| 营收增长 | 39% | 受Mounjaro、Zepbound以及广泛产品组合势头的推动 |
| 毛利率 | 84.4% | 同比上升80个基点 |
| 市场营销、销售及管理费用 | 增长14% | 反映了对现有和计划中上市产品的投入 |
| 研发费用 | 增长23% | 受管线投资和业务拓展驱动 |
| Non-GAAP履约利润率 | 54.2% | 上升5.9个百分点 |
| Non-GAAP每股收益 | 7.48美元 | 包含4.57美元的已收购在研研发(IPR&D)费用;2025年第三季度每股收益为7.02美元,其中包含0.71美元的此类费用 |
| Mounjaro和Zepbound收入 | 超过160亿美元 | 较2025年第三季度增加60亿美元 |
| 资本回报 | 15亿美元股息;4亿美元股票回购 | 于第三季度执行 |
第三季度营收包括先前确定的约9亿美元项目,其中包括里程碑付款以及返利和折扣估计的变化。
受Zepbound和Mounjaro销量增加驱动,美国市场收入增长34%。报告的美国售价下降7%;若扣除对返利和折扣估计的有利调整,售价实际下降10%。
美国肠促胰岛素总处方量增长32%。减重类肠促胰岛素处方量增长82%,其中礼来产品占总处方的约六成,占注射类处方的七成以上。在2型糖尿病领域,肠促胰岛素处方量增长8%,礼来保持了60%以上的市场份额。
根据IQVIA测算,国际市场肠促胰岛素销量增长53%。礼来的份额较2026年第二季度提升近4个百分点,在美国以外市场达到约58%。
Medicare GLP-1过渡计划正在扩大老年群体的用药可及性。管理层表示,约75%的过渡计划参与者选择了注射疗法,而80%的现有使用者是首次接受肠促胰岛素治疗或此前未曾使用过。
继此前在阿联酋上市后,Foundayo本季度在英国、墨西哥和沙特阿拉伯上市。在美国,开始使用减重药物的患者中约有四成选择了Foundayo,Foundayo的新增患者数量环比翻倍。
管理层预计美国监管机构将于2026年第四季度针对Foundayo用于2型糖尿病做出监管决定。公司还预计2027年将在全球所有主要市场推广上市,计划在慢性体重管理和2型糖尿病领域开展40多项国际上市活动。
礼来肿瘤学、免疫学和神经科学核心产品的收入较2025年第三季度翻倍。
区域表现同样强劲。按固定汇率计算,欧洲市场收入增长29%,其中包括欧唐静(Jardiance)一次性4.1亿美元的里程碑付款。日本市场收入增长26%,中国市场增长62%,世界其他地区收入按固定汇率计算增长87%。
FDA批准替尔泊肽用于降低2型糖尿病成人的心血管风险,并批准了Onswik品牌的每周一次基础胰岛素efsitora alfa。礼来还获得了涉及吡托布鲁替尼(pirtobrutinib)和imlunestrant的新批准。
在伴有2型糖尿病和肥胖症的人群中,EloraTZP在48周时实现了23.3%的减重效果,比替尔泊肽高出57%。最高剂量组使糖化血红蛋白(A1c)降低2.9%,但因不良事件导致的停药率也较高。礼来计划在III期临床试验中使用更平稳的剂量递增方案。
公司收购了AtaiBeckley和Merida Biosciences。此外,公司还在德克萨斯州休斯敦(耗资65亿美元)和弗吉尼亚州里士满(耗资50亿美元)的生产基地开工建设。
| 2026年指引 | 更新后的区间 |
|---|---|
| 营收 | 910亿至920亿美元 |
| Non-GAAP履约利润率 | 52%-52.5% |
| Non-GAAP每股收益 | 35-36美元 |
更新后的展望反映了Medicare GLP-1过渡计划带来的更强劲的美国市场需求,以及Mounjaro在美国以外地区的持续增长。在未纳入第三季度每股4.57美元的已收购在研研发费用前,每股收益指引中值增加了4.07美元。
展望2027年,管理层预计美国肠促胰岛素销量将持续增长、过渡计划的可及性将带来全年效应,以及Foundayo预计将上市用于2型糖尿病。在国际市场,公司预计Mounjaro将保持领先地位,Foundayo的上市将助力进一步扩张市场。
管理层还预计实际净售价压力将持续存在,但销量的增长预计将足以抵消这一影响。公司将于1月发布第四季度业绩时提供正式的2027年指引。
管理层将自2026年初以来全年营收指引增加约100亿美元归因于:过渡计划的使用率、美国肠促胰岛素渗透率以及国际消费者需求均好于预期。管理层指出,肠促胰岛素渗透率目前仍然较低,在符合条件的美国患者中约为10%,在美国以外地区仅为2%,管理层认为这为未来多年留出了增长空间。
在治疗持续性方面,礼来表示,获得保险报销的Zepbound患者治疗持续时间接近此前度拉糖肽(Trulicity)观察到的16至18个月,而自费患者的治疗持续性接近有报销覆盖的市场水平。管理层预计口服疗法的依从性将低于每周一次的注射剂。
礼来预计2027年商业GLP-1的可及性将保持总体稳定,主要的覆盖增长可能来自Medicare和Medicaid。由此产生的渠道结构可能会降低每张处方的平均净收入。
在心血管代谢健康之外,管理层将肿瘤学、神经科学和免疫学视为潜在的长期增长支柱。礼来有8款肿瘤药物或重大适应症正处于或即将进入III期临床,并继续通过收购和授权许可在各个治疗领域补充早期及临床阶段的资产。
Ladies and gentlemen, thank you for standing by, and welcome to the Eli Lilly Third Quarter 2026 Earnings Conference Call. [Operator Instructions]
I would now like to turn the conference over to your host, Mike Czapar, Senior Vice President of Investor Relations. Please go ahead.
Good morning. Thank you for joining us for Eli Lilly and Company's Q3 2026 Earnings Call. I'm Mike Czapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO; Lucas Montarce, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific and Product Officer; Adrienne Brown, President of Lilly Immunology; Dr. Carole Ho, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly USA and Global Customer Capabilities; Jake Van Naarden, President of Lilly Oncology and Head of Business Development; Patrik Jonsson, President of Lilly International; and Ken Custer, President of Lilly Cardiometabolic Health.
During this call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to several factors, including those listed on Slide 4. Additional information concerning factors that could cause actual results to differ 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 is not intended to be promotional or otherwise influence prescribing decisions. Our commentary will focus on our non-GAAP financial measures.
Now I'll turn the call over to Dave.
Thank you, Mike. Q3 was another quarter of solid execution. We delivered strong financial results, raised our full year financial guidance, advanced our pipeline and expanded our manufacturing footprint. Revenue grew nearly $7 billion compared to Q3 2025, and our key product revenue increased by over $6 billion. Within key products, revenue from our oncology, immunology and neuroscience portfolio, doubled versus last year. We continued the global rollout of Foundayo, launching in the U.K., Mexico and Saudi Arabia for people with obesity and in Mexico for people with type 2 diabetes.
We achieved several key regulatory and pipeline milestones since our last call, including the U.S. approval of our new weekly insulin and new indications for Inluriyo, Jaypirca and Mounjaro As part of Medicare GLP-1 bridge program, we expanded access to obesity medicines in the U.S. approximately 20 million seniors. Since the July 1 launch, more than 0.5 million people have filled a prescription for a Lilly medicine through this program. We've heard positive feedback from patients and physicians about the initial implementation.
Within the GLP-1 Bridge program, the Lilly portfolio is performing well. Among new Bridge patients, 7 out of 10, starting on Lilly obesity medicine. We're encouraged to see the strong uptake of the Bridge program and believe it has the potential to both improve outcomes for seniors, and save costs for Medicare. A recently published paper from the University of Southern California Schaeffer Center for Health Policy & Economics, estimated the expansion of anti-obesity medications in Medicare could deliver over $20 billion of cumulative savings over 10 years. This is an encouraging indicator of the magnitude of savings the GLP-1 bridge program could generate.
We added to our pipeline through business development this quarter, acquiring AtaiBeckley and Merida Biosciences. We also progressed our manufacturing build-out to support our long-term growth outlook. We broke ground on 2 new manufacturing facilities a $6.5 billion facility in Houston, Texas, and a $5 billion facility in Richmond, Virginia. We distributed $1.5 billion of dividends in the third quarter and executed $400 million in share repurchases.
We launched a Lilly change the course commitment. Through this new initiative, we set a new goal. Reach as many people in resource-limited settings who have obesity and related diseases as in high-income countries prior to 2040. Lastly, we announced Patrick Johnson, President of Lilly International will retire at the end of 2026. Ilya Yuffa will expand his responsibilities to include Lilly International as part of a newly created role called President of Lilly Global Markets. I want to thank Patrick for his many contributions over a successful 36-year career at Lilly.
And now I'll turn the call over to Lucas to review our Q3 results.
Thanks, Dave. As shown on Slide 7, Q3 was another quarter of industry-leading financial results. Revenue grew 39% compared to Q3 2025, driven by Mounjaro, Zepbound and a strong momentum across therapeutic areas and geographies. Gross margin as a percentage of revenue increased 80 basis points to 84.4%. A as favorable product mix and improved cost of production were partially offset by lower realized prices. Marketing, selling and administrative expenses increased 14% as we invested in promotional activities to support current and planned product launches.
R&D expenses increased 23%, driven by investment in our growing pipeline of early and late-stage programs and new molecules added through business development. Our non-GAAP performance margin was 54.2%, an increase of 5.9 percentage points from Q3 2025 driven by revenue growth. Non-GAAP earnings per share were $7.48, including acquired IPR&D charges of $4.57. This compares to $7.02 in Q3 2025 which included $0.71 of acquired IPR&D charges.
On Slide 8, we quantify the effect of price, rate and volume on revenue growth. U.S. revenue increased 34% in Q3 primarily driven by volume growth from Zepbound and Mounjaro, partially offset by a 7% decline in price. U.S. price benefited from a favorable adjustment to estimates from rebates and discounts. Excluding this adjustment, U.S. price declined 10%. Europe revenue grew 29% in constant currency driven by sustained strong volume growth of Mounjaro. Growth also benefited from a $410 million onetime milestone payment related to Jardiance. No additional Jardiance milestone payment remains under our agreement with Boehringer Ingelheim.
In Japan, revenue grew 26% in constant currency, driven by Mounjaro and Kisunla. Mounjaro posted robust volume growth as share of new patient starts increased to over 50%. In China, revenue grew 62% in constant currency, driven by the uptick of Mounjaro. Mounjaro is the first medicine in China to exceed $1 billion of revenue during its first full year. In Rest of the World, revenue grew 87% in constant currency driven by Mounjaro, primarily in Korea, Turkey and Brazil. Q3 revenue was positively impacted by approximately $900 million of previously mentioned items, including milestones and changes to estimates for rebates and discounts.
On Slide 9, we provide an update on the performance of our key products. Within immunology, Ebglyss worldwide revenue grew 59% compared to Q3 2025. In the U.S., Ebglyss continued to gain share of new prescriptions in the specialty dermatology market and is the fastest growing medicine in atopic dermatitis. Oncology, Jaypirca had another strong quarter as worldwide revenue increased 59% compared to Q3 2025. In the U.S., Jaypirca was the fastest-growing BTK inhibitor as measured by total prescriptions. Inluriyo continued its impressive uptick in the metastatic breast cancer oats market, exiting Q3 with more than 60% share of new U.S. prescriptions and 40% of U.S. total prescriptions. In neuroscience, Kisunla revenue grew 175% compared to Q3 2025. Kisunla maintained its leadership position in U.S. amyloid-targeting therapies.
Diagnostic testing momentum continues to build, and the number of p-tau217 blood test more than doubled compared to Q3 2025, translating to more people being diagnosed with Alzheimer's disease and accessing treatment. Finally, in Cardiometabolic Health, Mounjaro and Zepbound combined for more than $16 billion of revenue, contributing $6 billion of growth compared to Q3 2025.
As seen on Slide 10, total prescriptions in the U.S., incretins market grew 32% compared to Q3 2025. Overall GLP-1s and the Medicare GLP-1 Bridge program are expanding the number of people taking incretin therapy. In the U.S., total increasing prescriptions for obesity grew 82% in Q3. Approximately 6 out of 10 total prescriptions and more than 7 out of 10 injectable prescriptions were for a Lilly medicine. In the U.S., Type 2 diabetes incretin total prescriptions grew 8% compared to Q3 2025. And the Lilly portfolio continues to lead here with more than 60% share of market. Outside the U.S., Lilly's portfolio again performed well.
Slide 11 shows aggregate trends in international incretins, which have increased by 53% since the same period last year as measured by IQVIA across sales. Lilly strengthened its leadership position outside the U.S., gaining nearly 4 percentage points of share compared to Q2 2026 to reach approximately 58%. Slide 12 provides an update on the Foundayo launch. In the U.S., total prescriptions and the share of new patients continue to rise. Approximately 4 in 10 patients starting an overall obesity medicine chose Foundayo and the number of new Foundayo patients in Q3 doubled from the previous quarter. We look forward to launching Foundayo in type 2 diabetes in the U.S. and expect regulatory action in Q4. Outside the U.S., Foundayo has launched in 4 countries and is under regulatory review in more than 4 additional countries. We continue to expect a global rollout in all major markets in 2027.
On Slide 13, we provide an update on year-to-date capital allocation. Moving to Slide 14 is our updated 2026 financial guidance. Based on a strong underlying performance across our portfolio, we now expect full year revenue to be between $91 billion and $92 billion. We saw strength in the U.S. driven by rapid uptake of Medicare GLP-1 Bridge program and outside of the U.S. from strong Mounjaro performance. Given our updated revenue outlook, we now expect non-GAAP performance margin to be between 52% and 52.5%. We expect non-GAAP earnings per share of $35 to $36. This reflects an increase of $4.07 per share at the midpoint of range before updates to the Q3 acquired IPR&D charges of $4.57 per share.
We are pleased with our Q3 results and confident in our ability to deliver another year of industry-leading growth. We will share our 2027 financial guidance on our Q4 call in January. However, I will share highlights on our initial thoughts regarding some of the pushes and pulls that we expect to impact our 2027 financial outlook. Beginning with the U.S. revenue, we expect sustained volume growth in the incretin market and the full year impact of the Medicare GLP-1 Bridge access and the launch of Foundayo in type 2 diabetes.
Outside the U.S., we expect Monjaro's leadership position to continue. We expect to launch Foundayo which will drive additional market growth. Consistent with prior years, we expect net realized price to be a headwind more than offset by volume growth. It is also worth noting that the 2026 revenue benefited from approximately $2 billion of onetime items primarily related to milestones payments and changes in estimates for rebates and discounts that we don't expect to record.
Now I will turn the call over to Dan to provide an update on our pipeline.
Thanks, Lucas. Since our last earnings call, we've made progress across Lilly R&D. I'll begin in cardiometabolic health by recapping our most recent Phase III readout from our GIP GLP-1 glucagon triple agonist, retatrutide. Just yesterday, we shared top line results from TRANSCEND T2D2, head-to-head trial of retatrutide versus semaglutide in people with type 2 diabetes. As shown on Slide 15, retatrutide delivered greater A1c reduction and more than double the weight loss of 2-milligram semaglutide.
Retatrutide reduced A1c by 2.2% compared to 1.8% on 2 milligrams of semaglutide. These data demonstrate retatrutide can provide even more glycemic control than an approved diabetes medicine, provide a potential new treatment option. What's even more striking was the 20% to 21% weight loss achieved in people taking retatrutide compared to 9.4% weight loss in the semaglutide arm. For people with type 2 diabetes who struggle to lose weight, retatrutide continues to demonstrate powerful weight loss alongside compelling glycemic control in this difficult-to-treat population.
Moving to another Lilly triple agonist. At last month's European Association for the Study of Diabetes meeting, we presented Phase II data for EloraTZP. EloraTZP is a combination of our selective amylin receptor agonist, or lintide in our GIP/GLP-1 dual agonist, tirzepatide. As shown on Slide 16, EloraTZP delivered weight loss of 23.3% at 48 weeks with people with type 2 diabetes and obesity. In a population that struggles to lose weight, this powerful combination delivered 57% more weight loss compared to tirzepatide, the world's most prescribed incretin.
In addition, the highest dose combination of EloraTZP delivered A1c reduction of 2.9% at 48 weeks. And more than 3 out of 4 patients achieved an A1c below 5.7%, a level associated with normal blood glucose. Pending replication of these first-of-their-kind results in our Phase III trials, we believe this drug could meaningfully improve what is possible in the treatment of type 2 diabetes and obesity. And these data highlight the potential importance of treating with 3 physiologic hormones at once.
Moving to Slide 17. As one might expect, when rapidly escalating doses of a medicine with multiple mechanisms, the highest dose EloraTZP arm had a higher discontinuation rate due to adverse events. As we move into Phase III, of course, we will use a slower optimized dose escalation schedule, which we anticipate will improve tolerability. Note that monotherapy of eloralintide showed excellent tolerability, with discontinuations due to adverse events lower than placebo. We look forward to beginning the Phase III trials of co-formulated EloraTZP imminently.
We also presented results from ACHIEVE-4, the cardiovascular outcomes trial of orforglipron in people with type 2 diabetes and obesity with increased cardiovascular risk. As shown on Slide 18, orforglipron met the primary endpoint of noninferiority versus insulin glargine, reaffirming its cardiovascular safety profile. An additional prespecified analysis compared to insulin glargine, orforglipron showed a 16% lower risk of MACE 4. And for people fortunate enough to have been randomized to receive orforglipron in this trial, there was a 57% lower risk of all-cause death. These data complement the 6 previously presented Phase III trials for orforglipron that support the potential of orforglipron as a foundational daily oral treatment for people with obesity and people with type 2 diabetes.
Also in cardiometabolic health this quarter, in the U.S., we received 2 important FDA approvals. The FDA approved tirzepatide to reduce cardiovascular risk in adults with type 2 diabetes and the FDA approved our once-weekly basal insulin, insulin efsitora alfa for adults with type 2 diabetes under the brand name Onswik. Weekly basal insulin could significantly improve patient experience by reducing the number of injections compared to daily basal insulin.
Moving to oncology. The FDA approved pirtobrutinib for certain patients with previously untreated CLL or SLL based on the brewing CLL 313 Phase III trial. Pirtobrutinib reduced the risk of disease progression or death by 80% compared to bendamustine plus rituximab. This approval underscores pertibrutinib's versatility across the CLL continuum of care. It cannot be used in the first-line setting for appropriate patients in addition to its valuable role in the relapsed or refractory post-covalent BTK inhibitor set.
The FDA also approved imlunestrant in combination with abemaciclib in ER-positive HER2-negative ESR1 mutated advanced breast cancer. The all-oral combination of imlunestrant and abemaciclib gives patients a treatment approach that targets the 2 central drivers of ER-positive breast cancer with an evidence-based treatment approach, established tolerability profile and no new monitoring requirements. We look forward to the results from EMBER-4 ongoing Phase III trial of imlunestrant in high-risk early breast cancer.
Elsewhere in oncology, we initiated a Phase III trial with our PI3 kinase alpha inhibitor, tersolisib in combination with the CDK4/6 inhibitor in endocrine therapy in advanced breast cancer. Tersolisib is a mutant-selective PI3-kinase alpha inhibitor intended to target the PI3 kinase mutations in breast cancer, while sparing normal PI3 kinase and healthy tissue. We believe this profile could lead to efficacy in the first-line metastatic setting, without as much of the toxicity as seen with other agents. We now have 8 new oncology medicines or major new indications that are in Phase III trials or will start Phase III shortly.
Moving to neuroscience. We completed the acquisition of AtaiBeckley, adding a portfolio of neuroplastogens with potential to treat depression and other serious mental health conditions. We're pleased to welcome the AtaiBeckley team to Lilly and look forward to advancing multiple clinical programs together.
Moving to immunology. We shared positive Phase III results for lebrikizumab in people with moderate to severe atopic dermatitis of the handset feet. Hand and foot atopic dermatitis is painful and difficult to treat, and these data show lebrikizumab can be a new option for patients without the need for topical treatments. We've submitted these data to the FDA for potential label update. We also shared 52-week results from Phase IIIb trials of ixekizumab and tirzepatide used together in people with psoriasis or psoriatic arthritis and obesity. The ixekizumab and tirzepatide arm delivered greater improvements in skin and joint outcomes, than ixekizumab alone, highlighting the importance of immunometabolic health.
Earlier this month, we closed the acquisition of Merida Biosciences, which is developing MER511, a precision immunology therapy in Phase I for Graves' disease and thyroid eye disease. This drug was designed to selectively degrade the disease-causing auto antibodies while preserving normal immune function. We're excited about the potential to help patients here, and we're pleased to welcome the Merida team to Lilly.
Slides 19 and 20 show pipeline movements since our last earnings call and the key events we expect in the remainder of 2026. We look forward to sharing more details about our pipeline at the upcoming Lilly Innovation Day on December 7. Although we won't have time to share everything we're working on, we'll do our best to curate a few examples that illustrate the depth and breadth of our capabilities and our pipeline.
I'll now turn the call back to Dave for closing remarks.
Thanks, Dan. We were pleased with the progress in Q3 and throughout 2026. We delivered another quarter of strong financial results, advanced our pipeline through Lilly Research Labs and business development and started building 2 new manufacturing facilities in the U.S. to support our future growth. While we continue to make excellent progress during a period of industry-leading growth, we remain focused on investing now to support our long-term vision redefine how a pharmaceutical company can improve human health at a global scale.
We've developed differentiated capabilities in R&D, manufacturing and commercial operations. where we're engaging directly with patients through platforms like Lilly Direct, changing the way people access health care. Given the depth of our anchorage pipeline, we expect our leadership position in cardiometabolic health and broad pipeline of next-generation obesity medicines to have an impact on global health for the decades to come. And with 3/4 of our clinical pipeline focused on diseases outside of obesity, we're developing new medicines that have the potential to impact a broad range of disease deliver diversified and durable growth for Lilly and our shareholders. Q3 was another strong quarter and another step toward our long-term goals.
Now I'll turn the call over to Mike to moderate the Q&A session.
Great. Thank you, Dave. We'd like to take questions from as many callers as possible. So to that end, consistent with prior quarters, please limit yourself to one question. Operator, please provide the instructions for how to join the queue and then we're ready for the first caller.
[Operator Instructions] Our first question today is coming from Chris Schott with JPMorgan.
Congrats on the progress. I guess a bigger picture one. You've raised guidance on the top line by roughly $10 billion year-to-date. I guess you reflect on what's happening here. Just talk a little bit about what the biggest surprises have been as we think about U.S. versus OUS cash pay versus commercial, et cetera? And probably, as importantly, just when you think about these dynamics going forward, are we just seeing a fundamentally larger incretin opportunity than you anticipated? Or is this more of a pull forward of demand as we think about that kind of longer addressable TAM for the company?
Great. Thanks, Chris, for the question. To talk a bit about guidance and our outlook for incretins in the future, we'll go to Lucas.
Yes, Chris, thank you for your question. And I think the starting point, if you go back when we set up the guide at the beginning of the year, you may remember that we have that slide with, again, the opportunities and still events that we had in front of us for 2026 to talk about the launch of Foundayo in Q2. We talk about starting the Medicare Bridge program. And then, of course, we talk about the variable of the growth of U.S. in particular, on the incretin out-of-pocket business and the runway of that growth.
Again, what you see now in the latest guidance that we just shared today is actually a confirmation that we are tracking well across all of them, even better than what we anticipated. So that's, I think, a positive confirmation of the trends and the solid performance that we continue to see.
Going back to your second part of the question about the runway of that is at pulling forward or not. If we think about it, if you look at just the incretin business, we're still scratching the surface on the number of patients that we can reach. If you look at the U.S. and we're talking about 1 out of 10 patients that we are reaching nowadays. And in U.S., we are talking about 2 patients out of 100 patients. So it's actually a really low base, though the number seems really big, $16 billion this quarter of increasing business. The runway of opportunity of growth is still for many years to come from my perspective.
And on top of that, we continue to fund the breadth across all the therapeutic areas. Super also happy to report the 100% growth on the rest of the key products across oncology, immunology and neuroscience. So that's just to give you some color about the short term and how we think about also long term.
Our next question is coming from Geoff Meacham with Citi.
I want to ask about what data you have on tirzepatide persistency in obesity just over the course of the past year or so. And importantly, when you look to next year, would you expect Foundayo and retatrutide to be different than that in terms of real world experience.
Thanks, Geoff. To talk about tirzepatide persistency and obesity and thoughts on the pipeline looking in the future, we'll go to Ilya.
Geoff, thanks for the question. What we've seen in persistency and actually before we even launched Zepbound, we've had success with Trulicity in the past, and that was kind of the standard of what is possible for chronic medicine for adherence, which ended up coming around 16 to 18 months of adherence. What we're seeing with Zepbound is that in the covered space, we continue to see the trajectory of being just as beneficial in terms of adherence as we've seen in Trulicity. And even in the self-pay, we're seeing that close to the covered market. So the persistency actually for iconic medication and is doing extraordinarily well.
Now expectations for oral, it's still early. But as typical chronic medications as long as you take a look at orals, they typically are lower adherence overall relative to weekly injectable therapies, and that's what we expect to see. One additional data point, I think, will be important as we look at even the success of Bridge early days in Bridge having a low pocket helps with that friction point, and we're seeing improved adherence in bridge. So that will all play out as part of the different friction points, both in terms of out-of-pocket as well as the benefits that people gain from these therapies.
Our next question is coming from Seamus Fernandez with Guggenheim.
I'm going to do the non-obesity question. Kisunla is actually starting to show the prospect of becoming a blockbuster product and starting to grow faster, maybe a little bit faster overseas. But I was hoping, Dan, you might weigh in on the prospects for TB3, the prospects for success and how you see that program really evolving the treatment paradigm should it succeed, particularly in the context of some of the novel tau biomarkers that we're starting to see. I think there are a lot of questions from investors that we get on what really is the market opportunity here given the Kisunla uptake, but it does seem like some of those behaviors are changing.
Great. Thanks, Seamus. Always welcome Neuroscience questions. So we'll go to Carole talk about prospects for Kisunla and maybe kind of the neuroscience space more broadly?
Yes. We're very excited to see the growth of Kisunla over the last year, and this growth is both driven by our confidence in this product with its convenient 30-minute infusion time once monthly dosing and the opportunity for treat to clear in this patient population. We've also seen a tremendous growth in the opportunity for diagnosis with blood-based biomarkers with p-tau217 becoming available. And we see this becoming a diagnostic that enables access to early diagnosis potentially even in primary care offices in the future.
As we look at TRAILBLAZER 3, which is our study looking at prevention in cognitively unimpaired people looking at prevention of progression to early symptomatic Alzheimer's disease these biomarkers will certainly also enable early diagnosis for people that have risk concerns about their cognition before loss of their cognition. So we're excited both about the growth in early symptomatic Alzheimer's disease, but also if TRAILBLAZER 3 reads out positively, really expanding this market to earlier stages of disease where we already have preliminary evidence from our early symptomatic Alzheimer's disease space that treating earlier will have a more significant impact on cognition.
Our next question is coming from Evan Seigerman with BMO Capital Markets.
Bigger picture one here. So clearly, the incretin franchise has become an enormous earnings driver, but it also raises the question of what comes next. When you look beyond the cardiometabolic disease, where do you see the best opportunity to build Lilly's next multibillion-dollar growth pillar? And does recent BD activitie suggests that neuroscience and immunology are emerging as higher strategic priorities?
Great. Thanks, Evan, for the question about the next big opportunity after incretin. So we'll go to Dan to talk a bit about some of the pipeline opportunities he's excited about.
Thanks, Evan. I would say that we're excited about all 3 of our other therapeutic areas, which are immunology, neuroscience and oncology and the BD activity reflects not just our strategic intent to grow those areas. But the intersection of that strategic attempt with assets that are actually out there and are attractive to us.
Oncology is probably the space where we've made the most progress, and we highlighted 8 really important late-stage programs several of which could be quite large in size. For example, the recent Kelonia acquisition, which targets myeloma is a huge opportunity if the data continue to hold up the way we see them too.
Neuroscience, of course, is the area that has the largest unmet medical need and really the least progress in the pharmaceutical industry towards addressing that. We're firmly committed to making a difference for patients in the space. And you could see our acquisitions in sleep and psychiatry, combined with our in-house expertise in neurodegeneration are aimed to really grow that market on behalf of patients.
And then finally, immunology I think there's been a lot of crowding in immunology on a few probably important targets, but we also see a great opportunity actually to raise expectations in immunology with breakthrough therapies that I think, can deliver efficacy that's never been seen before. And that's what we're trying to do with programs like the Merida acquisition or the Orna acquisition, which is aimed at immune reset. So lots of growth opportunities across those areas.
Our next question is coming from Kerry Holford with Berenberg.
I wonder if you can speak a little more about Medicare bridge. How does the split between injectable and pill in that channel differ from others. It seems the majority of Medicare demand is injectable. I wonder has that surprised you with regard to your products in that space. And also could you talk to what proportion of patients in that Medicare channel for the Bridge program specifically and naive versus existing patients transferring from other channels?
Thank you, Kerry. We'll go to Ilya to talk a bit about Bridge, the injectable versus pill split as well as naive versus switches.
Yes. Thanks for the question. For Bridge 1, it's performed extraordinarily well. I think we knew that it was going to be a significant benefit for seniors. The program itself is simple in understanding the criteria and a low out of pocket. And so all of those things combined, we have seen about 3/4, 75% of people coming into Bridge going into injectable therapy. 7 out of 10 in total choosing Lilly medicine. And so we've performed really well across Bridge.
That is higher than maybe some of the self-pay segment. One of the components of that is the same low out-of-pocket and getting the greatest efficacy in the standard of care that's been established in obesity has favored Zepbound in particular, but we're seeing good growth and uptake of orals and Foundayo as well.
In terms of expanding number of people actually being treated after the first bolus of people coming into Medicare. We're seeing now about 80% of the people getting treatment under Bridge are naive or have not been on incretin therapy in the past. And so we see this as a significant driver of access long term. And it's still early days. And while it's performing above our expectations, we see continued opportunity here to expand access and utilization and not only improve care of seniors, but as we shared earlier on independent study, also a potential of saving significant amount for Medicare overall.
Our next question is coming from Asad Haider with Goldman Sachs.
Maybe just back to Foundayo, thanks for the comments earlier, and I know that it's still very early in the trajectory, but just curious to hear any updated framing on how the launch is playing out both in the U.S. as well as internationally in the context of both competitive dynamics versus oral Wegovy and then your own internal expectations. And then on the titration schedule for Foundayo, the 2 lower doses still represent about 75% to 80% of TRxs in recent weeks. So where do you see that going at steady state?
Great. Thanks, Asad. I think we'll start maybe with international and go to Patrick to talk a bit about some of the U.S. launches and then Ilya maybe a couple of nuggets on the U.S. as well.
Well, thank you very much. We have now launched in 4 markets outside the U.S. We started with the UAE very late in Q2. In the second half of Q3, we launched in U.K., Saudi and Mexico I would say that so far, the launch is very much in line with our expectations. A lot of similarities with the learnings from the U.S. in terms of the orals are truly expanding the market and we see a huge amount of patients actually being new to incretins.
In Middle East, I think we have the political situation to take into account that we are the market leader in UAE competition from Wegovy. In Saudi, we have launched in both type 2 and chronic rate management, and we have a good uptick U.K., we have been subject to the pre-vetting requirements by the MHRA. So we have actually not been able to fully promote until now in October, but the signs here are also that the orals are expanding the market.
Mexico, week 6, a very good uptake and actually slightly above our expectations. But most importantly, I think we see that there is a lot of work to be done here, and we need to do all the work that has been done in the U.S. as well. We recently got the CHMP positive opinion that should hopefully result in a regulatory approval by year-end, and we are ready to launch across chronic weight management in type 2 diabetes in more than 40 markets next year, but the initial focus is going to be on cash pay and chronic weight management since type 2 reimbursed and will take some time.
Yes. In the U.S., we've made significant progress since last quarter. You've seen over 0.5 million TRx in the quarter, but the fundamentals in some of the communicators that we've been talking about as part of our initial launch have been moving in a really positive direction. Consumer awareness and interest has improved with our investment in campaign with Martha Stewart, you're seeing Also, a number of trialists have more than doubled since last quarter, and so we're seeing good progression of adoption from providers. And that's showing up in our shared market.
So our NBRx share market is approaching around 4 out of 10. And so good progress overall for the growth of Foundayo in the oral segment. And even in the sequential growth of orals within -- from Q2 to Q3, we're taking 45% of that growth with Foundayo. In terms of the titration, it's expected that it takes time to titrate to the maintenance doses. But we've actually seen good progress on our maintenance services. We have multiple maintenance doses. So that 25% of people are at one of our maintenance doses. That's actually higher than what you see on Wegovy pill. And so we're encouraged by that. Of course, that's something continue to monitor, but the experience overall that we're seeing both from provider and consumer has been positive.
I would just add, we're under review for type 2 diabetes. We see that as an extraordinary opportunity for Foundayo as well. Remembering today in the U.S., roughly half the volume of GLP-1s is in diabetes. So that's a big market expansion. Of course, it needs access and reimbursement when we get that. But that's very promising sort of another leg to the stool here for the Foundayo performance.
Our next question is coming from Steve Scala with TD Cowen.
This is a follow-up to Chris' earlier question and with all due respect, Lilly's financial guidance hasn't been a good predictor on ultimate results. And I'm curious what is the most frequent source of the surprise. So specifically, has it tended to be positive unit developments or has it been lack of negatives on price or is it some desire to just lean incredibly cautiously on guidance?
And if it's the latter, why is that? A key for investors, I think, is to determine when the surprise factor runs its course. So any color would be appreciated.
Great. Thanks, Steve, for the good direct question. We'll go to Lucas to maybe provide a little extra color on guidance. And David, if you want to add anything, feel free to all.
Yes, Steve, thank you for the question. I think in terms of the variables that I described on the first question are still, again, the variables that we had when we started the year, of course, again, now with yesterday newspaper, you think about that, again, we are performing very much better than again, what we had initially guided to. But if you look at the runway of that growth across the U.S., I know U.S. has been all the events we were public about again the unknowns associated with that, starting with the Bridge program, when the rich program will start the uptick of that as well. the progression of all U.S. markets, both in share and also penetration. And those all played out better than what we anticipated.
So still the drivers are those ones. Again, we continue to guide to what we forecast in our internal bottom-up approach that we have on our forecasting model and try to as public as possible about how we see the projections and now we provided some perspective into 2027 as well. So I think in my -- from my perspective, we continue to drive, again, a very total process every single quarter and be public about again did variables that could affect positively or negatively as well our guidance projections.
Yes, Steve. I appreciate the question. You followed the company a long time. Our goal is to give us accurate projections we can. But of course, there's a symmetry with missing on the downside. That's like everyone's impulse. But let's remember, like we're in the middle of the largest new category expansion in the history of the pharmaceutical industry. And Billy is leading that. So there's a number of things that have never actually happened before that we're trying to project and we prefer to give a posture that investors can rely on versus one that is more speculative.
And the JPMorgan Conference at the beginning of the year, I said there's like 2 big variables this year. If I knew the ante, we would have had a tighter range. One was the uptake in Bridge, which we didn't really know. We weren't even sure about the start time of Bridge at that point. And the other was the depth of the consumer purchasing internationally and whether we were really just skimming very high net worth individuals in these out-of-pocket markets or if our middle income households would be interested in improving their health and losing weight at scale. And I think both of those this year turned out to be positive for us, thus the roughly $10 billion improvement over first time guide.
As time goes on, I suspect we'll have fewer and fewer of those never before done things, and the guidance can become more predictable. So I appreciate the question, but that's sort of how I've seen it in the last 3 years. And we're beating on the up, that's better than missing on the down. And I think that's good news, mostly not because of the earnings speeds, but because we're actually executing against a really scaled opportunity and performing well.
Our next question is coming from Terence Flynn with Morgan Stanley.
Maybe one on the pipeline for Dan. There's been a growing focus on longer acting incretins. You guys recently said you have 3 different programs in the clinic. So just wondering if we can expect any clinical data at the R&D Day on these programs? Or if you can tell us what the stage is of development because I think that is the probably the only hole you have in your incretin pipeline.
Thanks, Terence. We'll actually go to Ken to talk about the long-acting approach. And if there's anything to share beyond what's been public.
Thanks for the question, Terence. As we discussed previously, we do see an opportunity for longer-acting acreage, particularly in a category that's big with such a consumer emphasis, we're taking the same approach we usually do and we see an important square on the board that we want to fill, which is baking off several competing platforms to switch provides the best product possible.
This is a space where we think the molecule properties are really going to matter. And so that's why we haven't signal anything yet, but it is true we have multiple efforts in the clinic. Those are a range of different technological approaches, including existing time extension technologies as well as ones that could be part of the future. And then we have other efforts that we've disclosed in business development around formulation technologies. Again, we'll look at all these data and make an informed decision on which effort or efforts to advance to Phase III.
Our next question is coming from Trung Huynh with RBC.
So as you look to '27, what are you seeing in terms of opt- in terms of GLP-1 coverage amongst the larger employers in the U.S. And with those dynamics in mind and Bridge continuing to ramp, could your U.S. channel mix meaningfully evolve next year? So it potentially creates additional pricing pressure amongst the mid-teens decline that you've absorbed in '26 or could we see pricing headwinds in the same range for '27?
Thanks, Trung. I will go to Ilya to talk about 2027 early opt-in trends and maybe the broader access environment as well as we look into the next year?
Yes. Overall, obviously, there's been noise around a number of employers opting out of coverage at the same time. We're having positive discussions to connect and other channels on improving access there as well. Our expectation is that overall access on the commercial side will maintain relatively stable through 2027. Obviously, we continue to have conversions to improve on that. The main access improvements overall for '27 were more likely be predominantly growth of Medicare and Medicaid as opportunities for expanded coverage.
That we'll have a segment mix more towards a lower price -- lower net price, not about decreasing the price overall, but more just a segment mix that as well as some level of self-pay and the lower net price per TRx. And in terms of commercial overall pricing, I would expect a modest and disciplined approach around pricing and access to maintain but overall stable in the commercial and increased coverage in Medicare and Medicaid.
Our next question is coming from Akash Tewari with Jefferies.
So your team has talked about generally predictable and consistent GLP-1 pricing declines in the U.S. out to the end of the decade. How does that look ex U.S.? Could we see more stability there than maybe investors expect? And how do you think about the net price per patient in the U.S. versus international markets ex China evolving over time? It currently seems quite similar.
And Dave, you mentioned something interesting. Can you talk a bit more about the size of this emerging middle-income cash pay international market opportunity relative to what we've seen in the U.S. so far?
Thanks, Akash. Sounds like questions for Patrick. So talk a bit about pricing expectations kind of on the cadence from here, thinking about net price U.S. versus ex U.S.? And anything about the emergence of a middle income cash pay market.
Yes. Thank you very much. We have taken a very disciplined approach to pricing OUS. And I think we have seen that both providers, consumers and payers are willing to pay for a differentiated product. And we have seen that even after the launch of generics in India, Brazil and Canada, we are holding our shares and continue to grow, and that's a discipline that we will continue to apply. In terms of the out-of-pocket willingness, we actually see quite a big willingness to pay out of pocket for U.S. as well.
Of course, when markets are getting further penetrated and like the U.K., where we launched more than 2 years ago and where we have a penetration very much along the lines of the U.S., we see a lower growth as we expected. I think overall, taking into account where we are, penetration-wise, low single digit long term, we see a tremendous opportunity, OUS we will continue our efforts as well to gain Type 2 reimbursement, which is very important. And we made some progress in Q3 here now having 9 European markets covered, but we will continue those efforts and continue to take a disciplined approach in terms of pricing.
Maybe just a comment on the ex U.S. versus U.S. I mean our goal because of the consumer nature of this is to a much tighter band of pricing on OBC medicines than maybe you've seen historically in other medicine categories.
Our next question is coming from Umer Raffat with Evercore.
I wanted to spend a quick second on a potentially sizable opportunity in early breast cancer for imlunestrant. And I understand there's a planned interim for you guys a competitor trial stopped on interim. A, how should we think about early stoppage odds for your trial? And perhaps more importantly, if you could put the effect size comparisons versus lidERA knowing that the treatment setting for you is a little more real world with meaningful post CDK4 penetration?
Thank you, Umer. We'll go to Jake to talk a bit about EMBER-4.
Thanks, Umer. Super excited about Inluriyo both in its current actual commercial performance, where it's doing great and helping lots of people with monotherapy and new combination with Verzenio. And as you mentioned, the real big opportunity is in the adjuvant setting with the EMBER-4 study. We've not talked about interim analysis on these studies on the study. We've been very consistent that we expect the study to read out in 2027 next year. So we're sticking with that. That is what we expect.
I think you're raising a good point at the treatment setting that we're exploring is much more real world, I think, than what was examined in lidERA, both in the context of the prevalent population that exists that may want to switch from existing endocrine therapy to new oral SERD and a study run in the context of modern standard of care of CDK4/6 inhibitors like Verzenio, which our study had and there's didn't.
So a bunch of differences. I think our study does read out successfully, I hope it will be much more relevant to clinical practice and easy to understand how to slot it in. I don't want to comment on anticipated effect sizes because we just need to start to read out and see what it shows us. but excited to get to that point.
Our next question is coming from Carter Gould with Cantor.
Maybe just to go back to the Bridge program, had conversations with the admin or the various plan B sponsors that give you confidence this program will either be extended or balance will be revisited in a different iteration, I guess, to your point, just your confidence that there won't be a disruption at the end of '27.
Thanks, Carter. We'll go to Dave to talk a bit about our discussions with administration.
Yes. Well, I think we're pretty optimistic about expansion, I think, for 3 reasons, Carter. One is the early uptake is strong, and I think you see both demand and appropriate on-label use of the medications. The industry did a fantastic job implementing the PA criteria in a way that was not kind of over-indexed or under-indexed. And I think if we look at the people using the medicines, relatively high BMI, comorbid people. And that leads to the second point, which is cost effectiveness.
And I think we highlighted today the independent study from USC that estimates not just breakeven, but like massive cost savings for Medicare due to this program the CMS will -- because it's being done as a pilot program, we'll do their own analysis. But I think all signals now point to a pretty successful cost effectiveness which could yield either a legislative or a regulatory shift in the coverage permanently. In the meantime, I think there's a lot of energy with the people running CMS at the current point to continue this and the right way to do that is put this into the Part D benefit.
So I would expect -- and it's probably a good conversation to have on our Q1 call, this to then shift to working with the carriers for the '28 calendar year. And we'll certainly work with the administration and all our partners who supply party coverage to good access across our portfolio and continue the success of the program so far.
Thanks, Dave. We'll try to squeeze in 2 more if we could, please.
Our next question is coming from Michael Yee with UBS Securities.
Maybe just a long-term portfolio question around city and how you view a consumerism driven market where people will gravitate towards differentiated or different options within your portfolio. So I'm thinking about retatrutide and Amylin. Can you maybe just put on your prediction at about what the portfolio would look like and how consumers would choose between these different products given various competition and price declines.
Thanks, Mike. We'll go to Ken to talk about the breadth of the obesity portfolio and how to think about what patients each are for.
Thanks, Mike, for the question. Maybe let's start with the size of the problem we're confronting here is 10 million or so people living in the U.S. with obesity or overweight and internationally. That number has a at the start of it, that's why we're pursuing a portfolio approach knowing that many individuals will seek out and find over time what works best for them. each of the molecules in our growing portfolio, they have unique features and probably each of them can fill multiple roles.
We talked about how Foundayo was a great on-ramp for patients earlier in the weight loss journey, but can be a great maintenance option as well. Tirzepatide we see as sort of a cornerstone with a growing body of evidence to support it, including Surround MMO very soon. And then as we focus on RETA, this is a medicine that looks like it could do a lot of jobs on the high end, delivering tremendous power at the lower end, delivering a lot of simplicity and really differentiated responses in some important subpopulations, including men and type 2 diabetics, where it's the first agent that's ever shown greater than 2% -- or excuse me, 20% weight lowering. Beyond that, we have our selective amylin portfolio, which opens up a new pharmacological access that can offer incretin like weight lowering with really more placebo like GI tolerability.
And then last but not least, the LR TGP, we see this as sort of the most physiological approach yet to weight loss that could also again play a lot of roles and this including providing really differentiated HbA1c lowering in patients with type 2 diabetes. So again, all of these agents, we think they can play a lot of roles. We probably can't a priority stipulate for any individual patient what's going to work best for them. But what's important to us is that we offer all of them, we offer choice. We put them on a really a platform with a consistent appearance experience that allows patients to start, switch and step up to any Lilly medicine that works best for them. And overall, no matter which one they choose they'll still be on a Lilly medicine.
Great. Thanks, Ken. We'll go to the last question, please.
Our final question is coming from Courtney Breen with Bernstein.
I know we've spoken a little bit about the pipeline, but I used wanted to think about other sources of innovation and namely the M&A that you've been doing and licensing that you've been doing externally to support your pipeline. Obviously, there's been a rapid pace for the first part of this year. Can you just help us understand when you believe you're at in terms of the risk-reward balance across your portfolio, the types of areas that might be of interest to continue adding and how you are kind of ensuring that you're keeping the bar high as you continue to take on enrolling this pipeline kind of beyond what we see in Phase II right now.
Thanks, Courtney. We'll go to Jake to talk a bit about the kind of BD strategy, the process to assess different transactions and kind of the interest across the board.
Yes. Thanks for the question. It's funny, you mentioned risk reward. Risk is really our friend here. Risk allows us to actually create value. And 1 of the ways we can deploy that for the reasons we can because we don't need revenue tomorrow. I think we have this opportunity while the incretin business and the rest of the commercial businesses are doing so well. to plan for the next decade or 2 ahead, which allows us to take more risk in a calculated way.
And some of that is very early to deal making, which oftentimes are not really even press release by us. So some of them you don't maybe know as much about. And we've done a bunch of, I would say, clinical stage, but not super late-stage clinical deals this year where we see enough risk still within the program for us to create value, but enough derisking for us to feel confident that there's a real medicine or maybe more than 1 medicine there. And we can point to a handful of deals even on the year this year that fit that paradigm.
So I think you'll see more both of those categories from us across all the therapeutic areas. We're not solving for any 1 given therapeutic area. We're just solving for great products, great science and great people. that we can bring into the company and fuel growth into the decades to come. I think that gives us a competitive advantage, frankly, in how we look for what we want to take inside relative to our peers. So we have a pretty rigorous process to stay disciplined on a deal-by-deal basis, and I'm excited about what we've done so far and what's to come.
We'll go to Dave for a couple of closing comments.
Okay. Excellent. Thanks for joining us for today's call. Obviously, a strong quarter for the company. I want to take a moment though to promote an upcoming event, which is our December Investor Day. This will really be an R&D and pipeline focused today. We'll have other sections in that as well. And I hope all of you can join us live or if not remotely for that event. I also want to take a minute just to again congratulate Patrick on a great career, and I think this will be your last earnings call with us. You played a big part in our success over the last, well, 30 years of your career, but certainly the most recent 6 or 7. So thank you, Patrick, for everything.
Please follow up with the IR team if you have additional questions we didn't get to and look forward to seeing everyone in early December.
Thank you. This does conclude our conference for today. This conference will be made available for replay beginning at 1:00 p.m. today and running through 11/26/26 at midnight. You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 938904. International dialers can call (973) 528-0005. Again, those numbers are (800) 332-6854 and (973) 528-0005 with the access code 938904. Thank you for your participation, and you may now disconnect your lines.