These companies use the creative forces of capitalism to solve big problems—and do well by doing good.

Pharmaceutical company Eli Lilly is known for breaking ground in insulin, polio vaccines, penicillin, and antidepressants, most famously developing Prozac. Now, in the age of GLP-1 medications, which have transformed obesity and diabetes treatment, the company has shown it can move fast. Eli Lilly brought tirzepatide (sold as Mounjaro and Zepbound) from clinic to market in six years, compared with the company’s usual 11-year development cycles. An ongoing battle for Lilly, as well as Novo Nordisk, involves fighting copycat versions of its GLP-1 products made by compounders, and forcing them to modify their disputed claims. The FDA has warned patients and health care professionals about the dangers of compounded GLP-1 drugs and unapproved weight-loss medicine.

Change the World

The companies on the Global 500 employ 70.2 million people, and their revenue represents more than one-third of the world’s GDP.

Fortune Global 500

With a combined revenue of $21 trillion and $2.1 trillion in profits, the 2026 Fortune 500 is the definitive list of America's largest companies.

Eli Lilly, the Indiana-based pharma company, is celebrating its 150th anniversary in grand style: Its revenues have tripled since 2018, to $65.2 billion last year. It owes its surge to Mounjaro (for diabetes) and Zepbound (for weight management), which together command about 60% of the manically growing U.S. market for GLP-1 drugs.

Fortune 500

The 300 companies on this year’s list brought in over $12.5 trillion in revenue for the latest 12 months, with the median revenue figure at $24 billion.

America's Most Innovative Companies

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World's Most Admired Companies

Companies that foster an environment that supports professional growth are more likely to thrive and successfully adopt digital innovation. Here are the 100 best places to work in Europe—and how they stay that way.

Eli Lilly ranks 69 on this year’s Fortune 100 Best Companies to Work For – Europe list.

Fortune 100 Best Companies To Work For – Europe

The corporations on our annual list of the world's 500 largest companies combined to generate $41.7 trillion in revenue over the past year.

Almost $20 trillion in revenue—and a record-breaking $1.87 trillion in profits. Introducing the 2025 Fortune 500, the definitive list of the biggest companies in America.

Leaders in all industries rely more than ever on Big Tech—and appreciate the giants that deliver, at scale, without drama.

These companies are built to exhibit resilience amid volatility—and deliver better-than-average growth in the long term.

The Future 50

Founded over 145 years ago in Indianapolis, pharmaceutical company Eli Lilly established its first European affiliate in 1934. Lilly has provided more than two million doses of diabetes and cancer medicines to hospitals and patients in Ukraine via humanitarian partners, and its Foundation aims to extend Lilly's reach and impact and support programs that align with its philanthropic priorities. The pharma company's Skills First approach gives individuals without four-year degrees access to job opportunities that may not be available through traditional recruiting practices; apprentices receive a combination of formal training, on-the-job learning and mentoring in a key functional area to equip them for a full-time role.

The corporations on our annual list posted aggregate revenues of $41 trillion for the second year in a row.

Industries included in the sector are insurance and managed care, medical products and facilities, pharmacy services, and pharmaceutical companies.

Fortune Sector Leaders: Health Care

The Fortune 500, in its 70th year in 2024, ranks the biggest U.S. companies by revenue.

The 26th edition of the list shows how much esteem Big Tech giants command among other business leaders.

WMA 2024-Eli Lilly

The 25th Fortune World’s Most Admired Companies list suggests that tech giants’ peers respect them as much as ever.

The Fortune 500, in its 69th year in 2023, ranks the biggest U.S. companies by revenue.

Just as it dominates our economy, Big Tech now dominates Fortune’s annual ranking of corporate reputation.

This year’s Fortune 500 marks the 68th running of the list.

Total revenue for the world’s biggest companies fell 4.8% to $31.7 trillion this year—the first decline in half a decade.

This pharmaceutical giant has produced some of the most game-changing drugs in modern history, including the first commercially available insulin product for diabetics and Prozac, widely used by psychiatrists to treat depression. The company’s sales grew this year thanks in part to its antibody drug bamlanivimab, used for treating COVID-19.

This year’s Fortune 500 marks the 67th running of the list.

This year's Fortune 500 marks the 66th running of the list.

F500-2020-145-Eli-Lilly

The pharmaceutical giant was founded in Indianapolis in 1876. It introduced the world's first commercially available insulin product, Iletin, in 1923 for the treatment of diabetes. It was also the first company to manufacture and globally distribute Jonas Salk's polio vaccine. Today Lilly is known best for clinical depression drugs Prozac (1986) and Cymbalta (2004) and antipsychotic medication Zyprexa (1996), though its biggest revenue drivers are diabetes drugs Trulicity (2014) and Humalog (1996). Still headquartered in Indiana's capital city, the company made its largest acquisition ever in 2019 when it purchased Stamford, Conn.'s Loxo Oncology for $8 billion.

This year's Fortune 500 marks the 65th running of the list.

This year's Fortune 500 marks the 64th running of the list.

Here are the World's Most Admired Companies for 2017 as ranked in their industries. See who made the list.

This year's Fortune 500 marks the 63rd running of the list.

This year's Fortune 500 marks the 62nd running of the list.

This year's Fortune 500 marks the 61st running of the list. Wal-Mart claims the top spot again. See who made the list.

Wal-Mart stayed on top as its sales crept closer to half-a-trillion dollars. Apple moved into the top five. And UnitedHealth Group continued its steady climb. 

Future 50

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Change The World

Impact Segment

Eli Lilly is the powerhouse behind today’s blockbuster drugs Mounjaro (tirzepatide), prescribed for weight loss; erectile-dysfunction treatment Cialis (tadalafil); Humalog, a rapid-acting insulin; and diabetes treatment Trulicity. Founded in 1876 by Civil War veteran Eli Lilly, it was the first to mass-produce insulin in the 1920s, one of the first to mass-produce penicillin during World War II, and an early producer of the polio vaccine. The company has also developed several major mental-health drugs, including Prozac (fluoxetine), one of the most widely prescribed selective serotonin reuptake inhibitors in the world. Eli Lilly operates in over 100 countries.

Q2 2026

Q1 2026

Q4 2025

Q3 2025

Q2 2025

Q1 2025

Q4 2024

Eli Lilly (LLY): Company Profile, Stock Price, News, Rankings

legacy

Eli Lilly

eli lilly

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q4 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will be conducting a question-and-answer session, and instructions will be given at that time. Should you request assistance during the call, please press star, then zero, and an operator will assist you offline. I would now like to turn the conference over to your host, Mike Czapar, Senior Vice President of Investor Relations. Please go ahead.

Well, good morning. Thank you for joining us for Eli Lilly and Company's Q4 2025 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 Biology and Head of Business Development, Patrik Jonsson, President of Lilly International, and Ken Custer, President of Lilly Cardiometabolic Health. We're also joined by Marc Kemen, Susan Hedglin, and Wes Taul of the Investor Relations team. During this conference 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 four.

Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K, 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 and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note that our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave.

Thank you, Mike. 2025 was a strong year for Lilly. We delivered robust revenue growth, advanced our pipeline, expanded our manufacturing footprint, and helped over 70 million people around the world. In 2025, full-year revenue grew 45% compared to 2024, driven by our key products. We launched new medicines like Inluriyo, secured new indications for Omvoh and Jaypirca, and entered new markets as we completed the international rollouts of both Mounjaro and Kisunla. We generated positive clinical data in more than 25 phase III trials, including registrational trials to support two new incretins, Orforglipron and Retatrutide. We submitted Orforglipron for obesity in the U.S. and in more than 40 countries globally. We started 14 new phase III programs over the past few months, including Orforglipron and Tirzepatide, and we have one of the largest clinical stage pipelines in our company's history.

We executed 39 business development transactions across all our therapeutic areas and added multiple clinical stage assets through transactions, including Scorpion, Verve, SiteOne, Adverum, and the upcoming acquisition of Ventyx. We continue investing in artificial intelligence to discover and develop new medicines. In addition to our new supercomputer, we recently announced a new collaboration with NVIDIA to open a co-innovation AI lab. This project will combine Lilly's scientific expertise with NVIDIA's leading technology to accelerate drug discovery. We progressed our manufacturing expansion efforts and announced plans to build multiple new manufacturing sites in the U.S. and Europe. We increased our manufacturing capacity and began making medicine at our new sites in Wisconsin and North Carolina. We exceeded our goal to produce 1.8 times the number of incretin doses in the second half of 2025 compared to the second half of 2024.

Since 2020, we've committed over $55 billion, the largest manufacturing build-out in company history. We announced an agreement with the U.S. government to provide access to obesity medicines to millions of Americans with insurance through Medicare and Medicaid. We're proud of our ability to bring these important medicines to patients at a cost of only $50 per month out of pocket. The number of people engaging with our U.S. direct-to-patient platform, LillyDirect, increased to over 1 million patients in 2025. Our most popular offering, the Zepbound self-pay vials, now makes up one-third of new patient starts who start on any brand of obesity medication. Lastly, we distributed $1.3 billion in dividends and $1.5 billion in share repurchases.

We also strengthened our leadership team with the addition of two new executives, and I welcome both Carole Ho and Adrienne Brown to this call for the first time. Now I'll turn it over to Lucas to review our Q4 results and share details on the 2026 guide.

Thanks, Dave. We delivered robust financial performance in 2025. Our full-year revenue of $65.2 billion increased by 45% compared to 2024, and earnings per share grew by 86% to $24.21. Q4 financial performance was also strong, as shown on slide seven. Revenue grew 43% compared to Q4 2024, driven by our key products. Gross margin as a percentage of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved production costs were offset by lower realized prices. R&D expenses increased by 26%, driven by continued investments in our early and late-stage portfolio. Marketing, selling, and administrative expenses increased 29%, driven by promotional efforts to support our ongoing and future launches.... Our non-GAAP performance margin was 47.2%, an increase of 4.2 percentage points compared to Q4 2024.

Our effective tax rate was 19.7%, and earnings per share were $7.54, inclusive of $0.52 of acquired IPR&D charges. This compares to earnings per share of $5.32 in Q4 2024, which included $0.19 of acquired IPR&D charges. On Slide 8, we quantify the effect of price, rate, and volume on revenue. U.S. revenue increased 43% in Q4, driven by volume growth of Mounjaro and Zepbound, partially offset by a 7% decline in price. Revenue growth was strong outside the U.S. as well, driven by double-digit volume growth in Europe, Japan, and China. In rest of the world, volume doubled, driven by the launch of Mounjaro in new markets.

On slide nine, we provide an update on the performance of our key products, which contributed over $13 billion to revenue this quarter and grew by 91% compared to Q4 2024. Beginning with neuroscience, Kisunla recently became the U.S. market leader in the amyloid-targeting therapy space, with more than 50% share of total prescriptions. Revenue was $109 million, driven by overall market growth, increased awareness and diagnosis of Alzheimer's disease, as well as increased prescriber adoption based on Kisunla's clinical profile. In immunology, Ebglyss delivers solid performance in atopic dermatitis, where total prescriptions increased 25% compared to Q3 2025. Omvoh continued its uptake, and global revenue increased 55% compared to the fourth quarter in 2024. Jaypirca posted another strong quarter of sales performance, and global sales grew 30% compared to Q4 2024.

We recently received an expanded U.S. indication to include people previously treated with a covalent BTK inhibitor, significantly increasing the number of people who can benefit from this medicine. Verzenio global sales increased 3%, driven by volume growth outside the U.S. Verzenio remains the market leader in its early breast cancer indication. However, overall market penetration has reached a plateau, as reflected in U.S. trends. Finally, in cardiometabolic health, Zepbound and Mounjaro both delivered strong results. Outside the U.S., the positive uptake trends of Mounjaro continued, particularly in our newest launch countries in Latin America and Asia. We have launched in all major markets and are now the increased share of market leader outside the U.S. as well. Moving to the U.S., as shown on slide 10, our combined incretin analog market continues its robust growth trajectory, with total prescriptions increasing by 33% compared to Q4 2024.

As market penetration within the eligible population of people with obesity is only mid-single digits, we believe there is room for market expansion and sustained market growth in the quarters and years to come. U.S. Zepbound revenue more than doubled compared to Q4 2024. Zepbound continues to be the market leader in the branded obesity market, with nearly 70% share of new prescriptions. U.S. total prescription growth for Zepbound was robust, both in auto-injectors and vials. We are encouraged to see sustained growth uptake of Zepbound vials, which represented approximately one-third of total Zepbound prescriptions and nearly 50% of new Zepbound prescriptions in Q4. In the U.S., Mounjaro expanded market leadership in the type 2 diabetes incretin market, exiting the quarter with over 55% of new prescriptions. On slide 11, we provide an update on capital allocation.

Moving to slide 12 and 13, we share our 2026 financial guidance and highlight key factors that will impact our financial outlook. We expect revenue to be between $80 billion and $83 billion. The midpoint of our revenue range is an increase of 25% compared to 2025. We expect to deliver industry-leading volume growth driven by our key products, partially offset by lower realized prices. Price is expected to be a drag on growth in the low to mid-teens. Three factors will impact U.S. price: the government access agreement for obesity medicines, updated direct-to-patient Zepbound pricing, and lower Medicaid prices for later lifecycle medicines. Pricing outside the U.S. will be impacted by Mounjaro's inclusion on China National Reimbursement Drug List for type 2 diabetes.

We believe these price concessions will be more than offset by increased volume over time as we expand the number of people who can benefit from Lilly medicines. As I shared earlier, we continue to see robust growth trends in the U.S. incretin analogs market, and we expect a similar trajectory to continue in 2026. As seen with other new launches, we expect the launch of oral GLP-1s to expand the addressable market. We expect our Orforglipron to launch for chronic weight management in the U.S. during the second quarter of 2026, and to launch in most international markets during 2027. We anticipate new Medicare access to obesity medicines will become effective no later than July 1, 2026.

While we anticipate a reduction in Medicaid access in 2026 due to key states like California removing obesity coverage, we expect new states will add coverage for people with Medicaid in 2027. Within revenue, we anticipate Ebglyss, Jaypirca, Inluriyo, Kisunla, and Omvoh will all contribute to growth, whereas late-life cycle products like Trulicity, Taltz, Verzenio are expected to be flat or decline. We expect our non-GAAP performance margin to be between 46% and 47.5%. Across the P&L, there are pushes and pulls that we anticipate will impact our performance margin expectations. We expect gross margin will be relatively stable to slightly down compared to Q4 2025, as favorable product mix and increased productivity are offset by price and new facilities coming online. Consistent with our strategy to invest in innovation, we expect R&D expenses will scale up in 2026.

We have 36 active phase III programs in our pipeline and plan to initiate even more new programs in 2026. With one of the largest clinical stage pipeline in company history, we are investing to maximize the impact of these potential new medicines. Marketing, selling, and administrative expenses are expected to grow as we invest to support new launches across therapeutic areas. As we launch new medicines, we will fully invest in variable expenses while controlling fixed costs by leveraging our existing commercial footprint. We expect earnings per share of between $33.50 and $35, setting us up for another year of strong top-line now and bottom line growth. Now, I will turn the call over to Dan to highlight our progress on R&D.

Thanks, Lucas. Since our last earnings call, we've made significant progress in R&D. I'll share updates by therapeutic area, including select data highlights from recent phase III announcements, a final update on 2023 key events, and the potential 2026 outcomes on which we are now focused. Beginning with immunology, just a few weeks ago, we released top-line data from TOGETHER-PsA, a randomized, phase III-B trial evaluating Ixekizumab plus Tirzepatide, as compared to Ixekizumab alone, in people with psoriatic arthritis and obesity. This first-of-its-kind study assessed whether a concomitant treatment with an incretin could deliver additional efficacy when added to an existing immunology treatment.

As shown on slide 14, the combination not only achieved its primary endpoint, at least 50% reduction in psoriatic arthritis activity plus 10% weight reduction, but also showed a 64% relative increase in the proportion of patients achieving a 50% reduction in their psoriatic arthritis symptoms compared to ixekizumab alone. An important finding from the study was the potential effect of tirzepatide when added to ixekizumab on psoriatic arthritis symptoms via both weight-dependent and also weight-independent mechanisms. These results further support existing treatment guidelines for psoriatic arthritis that recommend treatment of comorbid obesity and shed further light on how incretins may have a positive effect on other diseases independent from weight loss. We look forward to publishing these data in more detail in a peer-reviewed journal and presenting them at an upcoming medical meeting.

With this important result in hand, we are encouraged about our ongoing trial studying ixekizumab and tirzepatide in psoriasis. In two separate studies of mirikizumab, tirzepatide, Crohn's disease, and ulcerative colitis. We also advanced our new GIP/GLP-1 agonist, tirzepatide, into a phase II study of asthma, another serious immunologic disease that we think may benefit from dual GIP/GLP-1 therapy. Moving to oncology, the FDA granted full approval for pirtobrutinib, including the expanded indication for treatment of adults with relapsed or refractory CLL/SLL, who have previously been treated with a covalent BTK inhibitor. This label update significantly increases the number of eligible patients and allows physicians to extend the use of BTK inhibitors to control disease longer. We also shared detailed data from two phase III pirtobrutinib trials, BRUIN CLL-313, and BRUIN CLL-314.

As shown on the left side of slide 15, in BRUIN CLL-313, pirtobrutinib improved progression-free survival, reducing the risk of progression or death by 80% versus bendamustine plus rituximab in treatment-naive CLL/SLL patients. This risk reduction is among the most compelling ever observed for a single-agent BTK inhibitor in a frontline CLL study. In the second study, shown on the right side of slide 15, BRUIN CLL-314, pirtobrutinib was compared to a covalent BTK inhibitor, ibrutinib, in treatment-naive or BTK inhibitor-naive patients. The study met the primary endpoint of non-inferiority of overall response rate, and while progression-free survival data were immature, they trended in favor of pirtobrutinib. Notably, in the early analysis of the treatment-naive subpopulation, as shown here, pirtobrutinib reduced the risk of progression or death by 76% compared to ibrutinib.

Both datasets were presented at the American Society of Hematology Annual Meeting and were simultaneously published in the Journal of Clinical Oncology. We submitted these results to regulatory authorities to potentially enable the use of Pirtobrutinib in earlier lines of therapy. Later this year, we expect results from an additional phase III Pirtobrutinib trial, BRUIN CLL-322. This trial evaluates Pirtobrutinib in addition to a fixed-duration regimen of Venetoclax and Rituximab in previously treated CLL/SLL patients. If successful, this could form the basis for an additional regulatory submission later this year.

We also presented updated combination data of Imlunestrant with Abemaciclib in metastatic breast cancer, which showed additional benefit compared to Imlunestrant alone. We submitted these data to regulators and are seeking to expand the Imlunestrant label. While we're encouraged by these new data for patients with metastatic breast cancer, we're even more excited about the opportunity for Imlunestrant in adjuvant breast cancer.

Our ongoing 8,000-patient adjuvant breast cancer trial, EMBER-4, is fully enrolled, and it will be the next phase III readout of an oral SERD for patients with early breast cancer. In other oncology updates, we advanced Sofetobart mepitecan, our next-generation antibody-drug conjugate, targeting folate receptor alpha into phase III testing for women with platinum-resistant ovarian cancer. We believe this program has the potential to benefit a broad population of patients with ovarian cancer, regardless of folate receptor alpha expression level, and may also offer improved tolerability compared to currently available antibody-drug conjugates. We plan to initiate a study in platinum-sensitive ovarian cancer later this year. We're excited that this medicine received breakthrough therapy designation from FDA earlier this year. We also expect to initiate new phase III programs for two other oncology molecules. The first is Tersolisimab, our mutant-selective PI3K alpha inhibitor.

We believe this program could represent the next generation of PI3K alpha-targeting agents by selectively targeting the pathway in cancerous, but not in healthy cells, thus overcoming a key limitation of currently available medicines. This approach could potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability. The second is Vepugratinib, an FGFR3 inhibitor that we believe may improve on the tolerability profile of existing agents and enable combination therapy in first-line metastatic urothelial carcinoma. In neuroscience, we began several trials exploring the use of incretins to treat substance use disorders and psychiatric conditions. Last quarter, we announced plans to initiate a phase III program of Brenipatide in alcohol use disorder. Since then, we've began dosing patients in this trial, and we have also launched additional Brenipatide phase II trials in tobacco use disorder and bipolar disorder.

We expect to initiate several more phase II and phase III trials in 2026, exploring how Brenipatide may be able to treat other conditions, including a phase III trial for major depressive disorder, testing if Brenipatide can prevent relapse of disease. In Alzheimer's disease, we continue to look forward to the results from TRAILBLAZER-ALZ 3, our study of donanemab in people with normal cognition but a positive blood test for Alzheimer's disease. This trial screened volunteers with a blood test for p-tau and randomized participants to a nine-month course of treatment with donanemab. By moving earlier in disease, even prior to individuals having any objective symptoms of Alzheimer's disease, the goal is to reduce the risks of them ever developing any impairment due to Alzheimer's. The primary completion is projected for 2027.

However, the study will read out when the target number of reduction events are accrued. Moving to cardiometabolic health, we had another busy quarter. We were excited to announce positive top-line results from the MAINTAIN trial, evaluating Orforglipron for weight maintenance. This unique phase III trial was designed to answer a common question from doctors and patients: Can people successfully maintain weight loss achieved on maximum tolerated dose of injectable incretins by switching to an oral GLP-1 therapy? Participants in MAINTAIN were previously on injectable Semaglutide or Tirzepatide, then switched to Orforglipron or placebo. As shown on slide 16, Orforglipron helped people maintain weight loss that they had achieved on injectable therapies, and the study met all primary and secondary endpoints. People who switched from Semaglutide to Orforglipron maintained their previously achieved weight loss with an average difference of just 0.9 kilograms.

This suggests that as an oral GLP-1 therapy, Orforglipron may provide similar weight loss maintenance as the maximum tolerated dose of the injectable GLP-1 therapy semaglutide. As expected, those who switched from maximum tolerated doses of the dual GIP/GLP-1 agonist tirzepatide to oral GLP-1 monotherapy, maintained much of their weight loss, although with a higher average difference of five kilograms. We expect to share detailed results later this year. Other Orforglipron updates since our last call include submission of Orforglipron to the FDA for treatment of obesity, with approval expected in Q2 of this year. Submission of Orforglipron for obesity and for type 2 diabetes in a number of other countries around the world. Initiation of Orforglipron phase III cardiovascular outcomes trial, and initiation of Orforglipron phase III for treatment for peripheral artery disease.

We look forward to completing the U.S. regulatory submission of orforglipron for type 2 diabetes later this year after the ACHIEVE-4 trial is complete. We also announced new data for our GIP, GLP-1, glucagon, triple agonist, retatrutide. In the first phase III trial to complete, TRIUMPH-4, we evaluated retatrutide in adults with obesity and knee osteoarthritis. Participants taking retatrutide 12 milligrams lost an average of 29% of their body weight at 68 weeks. While many people will not need this level of weight loss, we see an important potential role for molecules such as retatrutide in helping people with higher baseline BMIs or with more severe obesity-related comorbidities. Accordingly, we were pleased to see that retatrutide reduced pain scores by an average of 4.5 points, representing a 76% reduction in pain, and this was accompanied by significant improvement in physical function.

Impressively, more than 1 in 8 Retatrutide-treated patients were completely free from knee pain at the end of this trial. The safety profile was generally consistent with other incretins, with gastrointestinal events being most common. We observed higher discontinuation rates due to adverse events in people with lower baseline BMI, including participants who discontinued for perceived excessive weight loss. As shown on slide 17, patients with a baseline BMI of 35 or higher, which represented 84% of the trial population, had discontinuation rates due to adverse events, consistent with those observed in clinical trials of other injectable incretins. We expect to read out six additional phase III trials for Retatrutide in 2026, including the remainder of the core registration package for both the TRIUMPH obesity program and the TRANSCEND type 2 diabetes program.

Also in Q4, we started a phase III trial in high-risk metabolic dysfunction-associated steatotic liver disease, MASLD, studying retatrutide as well as tirzepatide for treatment of this disease. We're planning to submit the results of the core TRIUMPH program in 2026 to support applications for overweight and obesity, obstructive sleep apnea, and osteoarthritis of the knee for retatrutide. Based on the data we've seen so far, and pending these upcoming data readouts, we believe retatrutide may have the potential to become an important new treatment option for patients with significant weight loss with certain complications. Moving to tirzepatide, we're pleased that Zepbound was recently approved in the U.S. in a multi-use quick pen device. This presentation of tirzepatide is already available in many countries around the world as a convenient offering that includes 4 doses in a single pen.

We look forward to launching this new Zepbound offering in the U.S. within the next few weeks. Slide 18 shows pipeline movement since our last earnings call, and slide 19 shows the full list of key events achieved in 2025. Notably, we achieved positive outcomes for nearly all R&D key events in 2025, a rare set of results in this industry. Slide 20 shows key events expected in 2026, with potential for data readouts and regulatory actions across our therapeutic areas. In addition to the substantial progress we're making in immunology, neuroscience, and oncology, I want to take a moment to reflect on our growing incretin and obesity portfolio. Of course, there's been a lot of focus on Tirzepatide and Orforglipron, which I think is well warranted. Now excitement is growing for Retatrutide as well.

I see each of these as an example of a leading model within its own class. Behind these three incretin innovations, we have a robust pipeline of further inventions with potential to address patient needs, including our selective amylin agonist, Eloralintide, which is currently in phase III, as well as our next generation GIP, GLP-1 dual agonist Brenipatide, which is also now in phase III trials. Behind these, we have a number of earlier stage molecules that could similarly lead within new mechanisms and new classes of therapeutics for treatment of obesity. We've built a substantial scientific lead in this field, and we aim to widen the distance through our R&D. This past year was busy and productive, and we expect more of the same in 2026 as we continue to create meaningful medicines on behalf of the patients that need us.

Okay, thanks, Dan. We're pleased with all the progress in Q4 and throughout 2025. It was a year of strong execution for Lilly. We delivered exceptional business results, invested in our future, and helped millions of people around the world improve their health. Now I'll turn the call over to Mike to moderate the Q&A session.

Thanks, Dave. We'd like to take questions from as many callers as possible. So consistent with prior quarters, we will respond to one question per caller and end the call promptly at eleven. If you have more than one question, you can reenter the queue and we will get to your question if time allows. Paul, please provide the instructions for the Q&A session, and then we are ready for the first caller.

Thank you. At this time, we'll be conducting a question and answer session. If you have any questions, please press star one on your phone at this time. We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star one at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. The first question today is coming from Evan Seigerman from BMO Capital Markets. Evan, your line is live.

Hi, guys. Thank you so much for taking my question, and congratulations. A year from now on this call, I'd love for you to characterize what you would ask for or for good launch. Specifically, what are some of the metrics that you're looking to meet? I know you're not going to give guidance, but some qualitative kind of commentary would be most helpful. Thank you.

Great. Thanks for the question, Evan. It cut out a little bit, but I think you were just asking about a year from now, what are some things we'll be tracking on for orforglipron. So I think for that question, maybe we'll go to Ken to maybe talk about some things that we'll be looking at.

Sure. Thanks for the question about orforglipron. We're really excited to have this medicine submitted, not just in the U.S., but now 40 countries, and looking forward to launches beginning this year. You know, as I think about success factors for us going forward, maybe towards the end of the year, we'll be looking at a few things, first of which is market expansion. We're very encouraged by what we're seeing with oral Wegovy, as it validates our belief that there's a substantial number of people with overweight and obesity who've been sitting on the sidelines waiting for an oral option. It looks like these are mostly new starts. That means it's expanding the market, and that's good news for Lilly. We feel really good about the competitiveness of our profile. We've talked about that a lot on previous calls.

I think we're at the point now where we're going to pivot to how do the real-world results play out? We think this is going to be about patient satisfaction, and our profile, which is simple, with no restrictions on food and water intake, could make a big difference, in the real world. So we're excited to get off to the races here, see this market expand, and really look at overall patient satisfaction scores and real-world efficacy with these agents. Thanks.

Great. Thank you, Ken. Paul, ready for the next question?

The next question will be from Courtney Breen from Bernstein. Courtney, your line is live.

Hi, everyone. Thanks so much for taking the question today. Just building on the question around orforglipron, you mentioned that you have submitted in 40 countries. Traditionally, you tend to think about kind of a full year cycle for most approvals in many countries around the world. Can you just help us understand if you're anticipating any kind of accelerated pathways that you might be able to access in these ex-U.S. countries that would enable launch in 2026 for orforglipron, similar to some of the pathways that are available in the U.S., and you've been able to garner one of them? Thank you so much.

Great. Thanks, Courtney. And so, for the question about how we're thinking about OUS, regular approval timelines, we'll go to Patrik.

Well, thank you very much, Courtney. As I think we shared in the prepared remarks, outside the U.S., it's mainly going to be a matter of launching the first half of 2027. There will be a few markets late 2026, and a few exceptions, for countries like, for example, the UAE, but might reference an FDA-approved Orforglipron. So mainly a play late 2026, 2027 for the international markets.

Great. Thank you, Patrik. Next caller, please.

The next question will be from Chris Schott from JPMorgan. Chris, your line is live.

Great. Thanks so much for the question, and congrats on all the progress here. Can I just ask about international Mounjaro? This seemed like this was a very significant upside driver, at least relative to street numbers in 2025. And I'm just interested in your thoughts on the ramp from here as we think about the $3.3 billion 4Q result just reported. I know last year was about a lot of new market launches, and now you're in those markets. Like, how do we think about kind of sequential growth from these levels? Thank you.

Great. Thank you, Chris. Well, for the question on OUS Mounjaro performance and the ramp from here, we'll go back to Patrik.

Thank you very much, Chris. Well, you are right, Q4 was a very strong quarter for Mounjaro outside the U.S., and as Lucas referred to, we became the shadow market leader for total incretins, also internationally. When you look at 2026, I would just reflect back on 2025. We had major launches more or less in every quarter, with the exception of Q4. So I would actually look forward as a base for the 2026 growth, but also consider that there was a slight impact in Q4, driven by the NRDL listing in China, effective 1/1/2026, which slightly impacts the purchasing pattern in China in December. So see Q4 as a base for 2025... 2026. Moving forward, our business now OUS is 75% chronic weight management, and that's pretty much out of pocket.

25% is reimbursed for type 2 diabetes. So the priorities for 2026 will pretty much be market expansion, driving more penetration through patient activation when it comes to chronic weight management. And for type 2, we are leaning in to gain reimbursement in more countries. We're currently reimbursed in 9, with the last one being China, with the NRDL. And we will do that with a maintained discipline in terms of pricing. So I think overall, we are well positioned for a continued growth for Mounjaro outside the U.S. in 2026.

Thanks, Patrik. Next question, please, Paul.

The next question will be from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Great. Thanks so much for the question. So I'm actually going to ask a non-obesity question. So while you can't take your eye off the ball on obesity, just wondering why you couldn't attack immunology broadly in the same way as you have obesity, investing earlier, faster, and more aggressively, given the substantial generation that we're starting to see from the overall portfolio. What are the issues that would prevent you from doing something like this, whether it be by your internal efforts or perhaps a more aggressive business development approach, just because it seems like this is a, you know, sort of cash-driven opportunity where there's a lot of spend, but a huge amount of upside opportunity with $170 billion of total market out there to access?

Great. Thanks, Seamus, and extra credit for the non-obesity question. We'll go to Dan to talk about our approaches on attacking immunology early.

No, thanks, Seamus. It's a great question, and actually, I'll come to immunology in a second, but let me just first point out that across our non-obesity work, which is of course oncology, neuroscience, and immunology, we have our thumb on the scale for investment decisions. We see lots of good opportunities in those areas, and we're reinvesting some of the proceeds from the obesity opportunity to make sure we can further accelerate growth in those promising areas. So today you heard me talk a lot about the oncology portfolio, which I think is really blossoming right now. I have high hopes for immunology behind it.

I think there's really promising breaking science, including treating immunologic diseases earlier, and our research labs are doing everything in our power to harness that science. Today, I talked a little bit about some trials that are ongoing for incretins in immunology, which I think is promising, as are a number of other combination therapies that we now have in our late-stage clinical trials. So I'm excited both early and late about what we do in immunology.

Great! Thank you, Dan. Next caller, Paul.

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

Great. Congrats on the quarter. I had a question on the guidance, high level. Lucas, just wondering if you can talk about what's embedded for Medicare volume ramp in the back half of the year, and how that might drive the range we're seeing on the revenue side. And then, if that's had any impact on employer opt-ins on the commercial side. I know you guys previously talked about how that might have some impact to get some of the other employers over the hurdle on coverage. So just wondering if you're starting to see that yet?

Great. Thanks, Terence, for the question on guidance and kind of Medicare ramp in the back half of the year, as well as if there's any commercial opt-in. We'll go to Lucas.

Yeah, Terence, thank you. Thank you for the question. Maybe starting with Medicare, as highlighted in the, in the call text, basically, we are expecting that access to be granted no later than July 1st. And as I mentioned all along, this will take time to build over time, but we feel very, very positive about the opportunity to bring anti-obesity medications to patients in Medicare. As I mentioned, again, the copay, $50 for the patients will be a compelling value proposition as well. There is a bolus of patients that we have nowadays in the direct business that we believe are also Medicare patients. So expect that bolus, I think, is between 10%-20%, will actually move into the Medicare space.

I think that will happen relatively fast, and we will continue to build on top of that. So that's kind of the driver to start to think about, again, the penetration, but we'll build over time. We think about, again, more about the size of the opportunity in Medicare, thinking about 2027 as well. The second part of your question was about the employer opt-in. I have Ilya right next to me here as well to talk about it. But as all along you said, of course, again, the practice on physicians prescribing this medicine will become more natural, more broader in the anti-obesity medications. And physicians will be, again, more broadly, basically, also thinking about prescribing this in commercial. How that will then impact the employer side, I think the message is clear, right?

Again, there is a clear recognition of the class as a chronic disease, and basically that will, in my eyes, will, will propel also employers, also to think about, again, this class, and also employees to look for these class of medicines as well, to be covered as well. But I don't know if it's anything else that you would like to add, Ilya.

Yeah, maybe just some additional context, Terence, on commercial opt-in. Obviously, we start the year roughly on balance, relatively stable. There are some employers adding coverage, some removing some coverage, but we're putting additional focus in the employer space. We've stood up a team and also working with a number of third parties to actually provide alternative access channels to have some flexibility in design, transparency in the pricing, and the initial conversations and feedback has been positive. Of course, a lot of those decisions are for the following year. We anticipate having some of those decisions and increased coverage over time in the employer space as we head into the back end of this year and mostly into 2027.

Great. Thanks, Lucas and Ilya. Next question, please, Paul.

The next question will be from Geoff Meacham from Citi. Jeff, your line is live.

Great. Morning, everyone. Thanks for the question. Dan, I had one for you. The Together results are really super interesting. How are you thinking about the potential for combo therapies with Zepbound and either I&I or oncology or neuro? I wasn't sure, you know, what drives the investment priorities, whether it's the drug or the indication, and if there's a clear path to a labeling claim. Thank you.

Yeah. Thanks, Jeff. Again, another non-obesity question, so lots of extra credit on this call. We'll go to Adrienne to talk about some of the, the combination therapy approaches and some of the strategy there.

Sure. We see this as a significant opportunity. Obviously, you know, more than a billion people worldwide have immune diseases like atopic dermatitis, psoriasis, IBD, and asthma. But patients who have both immune diseases and obesity tend to have a higher disease burden. So we're really excited about the opportunity to find new ways to combat the underlying inflammation in these diseases, and potentially unlock better, longer-lasting results for these patients. So we have, you know, broad efforts underway to look at additional combinations. We have the Together PSO trial evaluating the use of Taltz and Zepbound for adults with moderate to severe plaque psoriasis and obesity or overweight. We expect those top-line results in the first half of 2026.

We're also looking at the TOGETHER-Amplify-PsA and TOGETHER-Amplify-PSO studies, assessing the effectiveness of adding Zepbound after starting Taltz for adults with PsA and moderate to severe plaque psoriasis.

We also have phase III-B commit studies in both ulcerative colitis as well as Crohn's disease, where we're looking at the concomitant use of Omvoh and Zepbound, and addressing outcomes for those patients, and then the phase II study of Brenipatide for people living with uncontrolled asthma. So we're excited to continue to pursue the applications of incretins and unlocking better outcomes for people with immune diseases.

Great. Thanks, Adrienne. Thanks for the question. Next caller, Paul.

The next question will be from Asad Haider from Goldman Sachs. Asad, your line is live.

Great. Thanks for taking the question, and congrats on all the progress. Back to obesity, with apologies, Mike, maybe just given the focus on pricing dynamics, can you just talk about what you're seeing in the contracting environment, broadly speaking, across the incretin portfolio? And also, what's your view on price elasticity in the cash channel as the year progresses? Thank you.

Great. Asad, thanks for the question. To go through kind of pricing in the U.S. and price elasticity, we'll go to Ilya.

Yeah, sure. Thanks for the question. Maybe just for the first part, in terms of the commercial access and contracting, obviously, we start the year with similar coverage as we ended 2025. We continue to have coverage for Zepbound in two of the three large PBMs. We continue the conversations around expanding access in those PBMs for, obviously, the introduction of Orforglipron in Q2, so we're in active discussions there. From a pricing standpoint, we've been pretty transparent on the pricing for 2026 as it relates to Part D, as well as our direct-to patient pricing, which we implemented at the end of December. And then we have ongoing conversations with improving and continuing access in the commercial segment.

In terms of price elasticity, we've seen over time, both in the U.S. and outside the U.S., that affordability and opportunity on the entry as well as predictability of cost for patients matter. That's why the out-of-pocket in Part D of $50 is an affordable option, as well as we've seen an increase in utilization of even Zepbound vial at the end of the year when we implemented improved entry price of $299 for Zepbound. So we continue to see that, and obviously, we're seeing significant encouraging uptake in the oral market, which is expansive and bringing new patients to obesity treatment. And we're excited to launch orforglipron soon with the entry price being similar to oral $7.

Great. Thank you, Ilya. Ready for the next question, please, Paul.

The next question will be from Mohit Bansal from Wells Fargo. Mohit, your line is live.

Great, thank you very much for taking my question. So a strategic one. So I would love to understand what is your latest thinking on the importance of getting obesity-related indications on the label? Because we kind of get the mixed message, a little bit of mixed message when we talk to payers, because they kind of think that these drugs are just for obesity for now. With NASH, they're still covering for obesity, with NASH. But do you think this could be an overtime long-term differentiator here, now that you are going into indications like I&I as well at this point? Thank you.

Thanks for the question, Mohit. So to kind of think about and address our strategy on obesity and expansion of indications more, more broadly, we'll go to Ilya, and then, Ken, you can add if you have any other development thoughts.

Sure. Thanks, Mohit, for the question. You know, what we've seen thus far, even with Zepbound and looking at Medicare population around sleep apnea, we're seeing an increase in utilization and thinking about obesity beyond weight and looking at outcomes related to obesity and a lot of comorbidities, as Dan had mentioned, even in our psoriatic arthritis trial with Taltz. When we talk to employers as well as payers, they think about the multiple aspects of obesity and what that means for coverage and cost long term. So we do see a growing body of evidence to support covering obesity medications for population and having a positive impact to public health beyond just weight.

Great. So thanks for the question on other potential avenues of exploration as it relates to complications and comorbidities. You know, as our incretin portfolio and amylin portfolio expands, we're always facing the question of: Do we spend our resources replicating findings from previous incretins on comorbidities and complications where we know these drugs are efficacious, or do we push into new areas and generate new evidence? You've probably seen with orforglipron, we're actually starting to explore new ideas like stress urinary incontinence, peripheral artery disease, and hypertension. We'll continue to look for new push incretins in addition to what we've talked about in the incretin space.

But we do also understand that with new molecules and new mechanisms, it's important to generate some data to continue to give prescribers and patients confidence that these medicines preserve the benefits of the previous class of medicines. So we continue to do that, too, but very pleased, I think, with our overall balance of investment across the incretin portfolio in both sort of established and emerging mechanisms of inter- or diseases of interest.

Great. Thank you both. Ready for the next question, please, Paul.

The next question will be from Umer Raffat from Evercore. Umer, your line is live.

Thank you, guys. As cash pay, I feel like, has been a very important driver of growth among other drivers, and I'm just trying to think out loud what the long-term implications of that could look like, especially with all the competition coming. On the one side, obviously, there's going to be tremendous brand loyalty, which is very important in cash pay, but on the other side, the traditional PBM contracts and rebate wall may not apply. So I'm just trying to think out loud how you're thinking about share retention and cash pay in the long run. Thank you.

Okay. Thanks for the question, Umer. To discuss a bit about sort of the cash pay dynamics, I'll ask actually, Ilya and Patrik to discuss how it plays out internationally and well, as well in the US. So Patrik, you want to start first?

Well, you know what? I think what we have been building over the last couple of years, learning a lot from the U.S., has really been the consumer centricity. I think it's a matter of building platforms along the lines as we have done in the U.S. with LillyDirect, where we are providing the opportunity for patients both to seek, start, and to statement. So I think that's a must that we need to continue to develop.

Yeah. Yeah, just to add on, I think we've learned quite a bit. There are frictions in the system for a number of diseases in the U.S. and globally. Obviously, we've seen that happen in obesity. What we've built within LillyDirect as a pretty significant scaled direct-to-consumer platform that helps address some of the frictions. Of course, we can continue to think about how we evolve that consumer experience and make this more seamless, at the same time, growing access across the different segments. And so I think both will play an important role, and we continue to look for ways for us to scale as well as improve on the experience over time.

Great. Thanks both for the comments. Let's go to the next question, please, Paul.

The next question will be from Alex Hammond, from Wolfe Research. Alex, your line is live.

Hey, guys. Thanks for taking the question. One on Eloralintide. So the weight loss results you guys presented last year looked really strong, but given prescribers and patients seem more interested in more favorable tolerability, how should we think about the potential for lower doses of Eloralintide and lower dose combos of Tirzepatide to potentially achieve a titration-free, placebo-like tolerability with weight loss, let's say, comparable to monotherapy GLP-1? Thank you.

Thanks, Alex. We'll go to Ken to talk about the Eloralintide development strategies and different ideas we're assessing.

Yeah, thanks for the question, Alex, on Eloralintide in future avenues.

We were really excited about the data we shared at Obesity last week, where patients achieved up to 20.1% weight loss for Eloralintide, with excellent tolerability that was improved with titration. In fact, in the three, six, nine milligram titration group, I think we only had one incidence of vomiting out of more than 50 patients. So, that compares, we think, really favorable versus, the existing incretin class. So we see a big opportunity for Eloralintide in patients who maybe just can't tolerate an incretin. We know that 5%-10% of patients in our trials tend to discontinue, on the incretin class, suggesting a pretty big opening given the size of the obesity market.

Of course, we're also interested in thinking about Eloralintide in combination with other mechanisms in action and what you alluded to with GIP plus GLP-1, plus amylin. It's a very sort of physiological construct, three nutrient-stimulated hormones, and we've shared that we are exploring that idea in the clinic. Nothing to share yet, but stay tuned, maybe towards the end of this year. We're testing other possible combinations, including the GIP agonist, Macugotide with Eloralintide as well. And so really just trying to understand the range of options, and like you said, is there really a, an optimal, very simple, permutation of mechanisms that could allow minimal or no titration with competitive efficacy?

Eli Lilly (LLY) Q4 2025 Earnings Call Transcript

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