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.

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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.

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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

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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 Q2 twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. Later, we will be conducting a question and answer session and instructions will be given at that time. I would now like to turn the conference over to your host, Mike Senior Vice President of Investor Relations. Please go ahead.

Good morning. Thank you for joining us for Eni Lilly and Company's Q2 twenty twenty five earnings call. I'm Mike Saffar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO Lucas Mondarce, Chief Financial Officer Doctor. Dan Skorowsky, Chief Scientific Officer and President of Lilly Immunology Ann White, President of Lilly Neuroscience Ilya Yufa, President of Lilly USA and Global Customer Capabilities Jake Van Arden, President of Lilly Oncology Patrick Janssen, President of Lilly International and Ken Custer, newly appointed President of Lilly Cardiometabolic Health.

We're also joined by Mark Heumann, Susan Hedgeland and Wyatt Wong of the Investor Relations team. During this call, we anticipate making projections and forward looking statements based on our current expectations. Our actual results may 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 ks 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 and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note our commentary will focus on our non GAAP financial measures. Now, I'll turn the call over to Dave.

Thanks, Mike. Q2 was a strong quarter. We delivered robust revenue growth, shared top line clinical data from multiple Phase III programs and invested in several initiatives that will support our future growth. Today, we shared positive top line data from the ATTAIN-one or Forgopron trial in people with obesity. In ATTAIN-one, patients taking the highest dose of Orforgopron lost more than 27 pounds, or 12.4% of their body weight.

In addition, the safety and tolerability in ATAIN-one was consistent with the injectable GLP-one class. Orforglipron also met all secondary endpoints in this study, improving key markers of metabolic health, such as blood pressure, cholesterol, and inflammation. This is the second positive phase three trial for orforglipron we reported this year, and we're encouraged by these results. Our goal from the beginning was to create a medicine that has a clinical profile consistent with approved GLP-one, while offering the convenience of a once daily pill and the production flexibility of small molecule chemistry to meet global demand. We believe this medicine has the potential to make a significant impact on human health, and we will now work with urgency to submit oforgopron around the world to meet the global challenge of obesity.

On slide six, we list key Q2 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 38% compared to Q2 twenty twenty four, driven by our key products. These include Evglis, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio and Zepbound. In The U. S, we continue the robust uptake of Zepbound and Mounjaro, and Lilly gained market share in the incretin analog class for the fourth quarter in a row.

Mounjaro also recently became the market leader in The U. S. In total prescriptions within the type two diabetes incretin market. Outside The U. S, we continue to launch Mounjaro in new countries.

These include Mexico and Brazil most recently. We have now launched Mounjaro in most major markets. Q2 was also a quarter of continued investment for Lilly. In addition to increasing commercial activities to support our newest medicines, we started multiple new clinical programs. While the company is experiencing rapid revenue growth, we're also increasing our R and D investment, as early phase program data continues to impress us, and to support our future growth of the company.

Our financial performance in the 2025 was strong. And as a result, we raised our revenue and earnings per share guidance. Lucas will cover this in more detail during the financial update. In addition to the results from ATTAIN-one, we achieved several key milestones since our last earnings call. These include the U.

S. FDA approval of a new dosing schedule for Kisumla, positive European CHMP opinion for Kisunla. Announced positive results in the SURPASS CVOT Phase three trial for tirzepatide in people with type two diabetes and heart disease. We announced positive results in the BREWIN CLL-three 14 Phase three trial of pirtobrutinib in CLL and SLL. And we launched the two highest doses of Zepbound in vials in The United States.

We announced and closed the acquisition of SiteOne Therapeutics, which expands Lilly's pain portfolio and adds a clinical stage non opioid pain program to our mix. And Verve Therapeutics, which adds new genetic medicines for cardiovascular disease with potential to only be administered once in a person's lifetime. We made progress in Q2 and throughout the 2025 to bring new manufacturing capacity online. We produced more than 1.6 times the amount of saleable incretive doses during the 2025 when compared to the 2024. This includes a significant step up in capacity from our recently constructed facility in Research Triangle Park, North Carolina.

We will continue to bring more capacity online in the 2025 and expect our production capabilities to increase further. We also plan to announce the location of two of our new U. S. Manufacturing facilities later this quarter. During the quarter, we distributed $1,300,000,000 in dividends and executed approximately $700,000,000 in share repurchases.

Before I turn the call over to Lucas, I'd like to offer some perspective on the drug pricing reform discussion that's going on. While we support the administration's position that medical research costs need to be shared more equitably across developed countries, it's also true that The US pharmaceutical market has significant defects, which shift costs to consumers and increase red tape. These problems also require urgent reform and make apples to apples comparisons of ex factory pricing inaccurate and misleading. At Lilly, we've already implemented several initiatives which directly lower patient costs for our most commonly used medicines. We operate a direct to consumer model at scale through Lilly Direct, which provides more affordable access to Lilly medicines.

This includes our leading weight loss medications that found at a discount of more than 50% off the list price. We also led in resolving insulin pricing issues in our country by reducing list prices by 70% and ensuring broad access to $35 monthly patient costs, including for Medicare. Negotiated prices in Europe come with broad access, low patient co pays, and without administrative hurdles like prior authorizations. There are also no intermediaries that distort prices, and hospitals do not seek profit by selling medicines and marking them up. If we import foreign price controls and insert them into a U.

S. System that isn't built to function for patients, we risk embracing the worst of two worlds, the low productivity and output of Europe's biopharma sector, with the high out of pocket and distorted prices of The US insurance market. Both today's patients and the future of new cures and treatments will suffer, along with The United States' competitiveness. Of course, we will engage and are committed to working constructively with the administration to find solutions that both benefit patients while preserving the hope for tomorrow's cures and the scientific base that has made America the envy of all in global pharmaceutical innovation. Now I'll turn the call over to Lucas to review our Q2 results.

Thanks, Dave. As shown on slide seven, Q2 was another strong quarter of financial performance. Revenue grew 38% compared to Q2 twenty twenty four, driven by our key products. Gross margin as a percentage of revenue was 85% in Q2, an increase of three percentage points versus the same quarter last year. The increase in gross margin was primarily driven by improved cost of production and favorable product mix, which were partially offset by lower realized prices.

Marketing, selling and administrative expenses increased by 30% as we continue to increase investment to support our newest launches across therapeutic areas and geographies. R and D expenses increased 23%, driven by higher expenses for late stage assets and additional investment in early stage research. Our non GAAP performance margin, which we define as gross margin less R and D, marketing, selling and administrative expenses as a percentage of revenue was 45.9%. Performance margin increased by more than six percentage points from Q2 twenty twenty four, driven by revenue growth. Our Q2 effective tax rate was 16.5%, consistent with Q2 twenty twenty four.

At the bottom line, earnings per share increased 61% to $6.31 including of a negative impact of $0.14 from acquired IPR and D charges. This compares to March in Q2 twenty twenty four, which also include $0.14 of acquired IPR and D charges. On Slide eight, we quantify the effect of price, rate and volume on revenue growth. U. S.

Revenue increased 38% in Q2, driven by strong volume growth of Zepan and Mojaro, partially offset by an 8% decline in price. In Europe, revenue grew 77% in constant currency, reflecting the strong uptake of Mounjaro. Japan revenue grew 7% in constant currency, driven by Mounjaro and Eplis. In China, revenue increased 19% in constant currency driven by volume growth of Mounjaro. Revenue in the rest of the world decreased by 1% in constant currency driven primarily by stocking in the base period related to Mounjaro launches in new markets.

This impact was largely offset by volume growth of Mounjaro and Verzenio this year. Slide nine provides an update of the performance of our key products. Beginning with immunology, Eplis continues to perform well in atopic dermatitis. New patient starts and revenue trends are strong and total prescriptions have nearly doubled since Q1. We also made progress securing access and Evolus is now covered by all three of the largest pharmacy benefit managers that represent 90% of people with commercial insurance.

For Ombo, we are one full quarter into the launch in Crohn's disease and are making progress in a competitive market. The new citrate free formulation is available in most major markets and we are seeing positive trends in new patient starts in The U. S, Germany, Japan and other international markets. Moving to oncology, physician feedback on JYPRICA continued to be very positive. While still only approving later lines of CLL and MCL, we have seen a strong uptake within the label population and encouraging trends regarding time on therapy.

We continue to generate additional data in Phase III trials that we believe will support an expanded label and use in early settings. We recently announced positive results of BERUIN three point four in CLL and SCLL is another positive step forward those goals. Verzenio global sales grew 12% in Q2, driven by volume growth. Verzenio continued to be the NBRx and TRx market leader in The U. S.

And standard of care in high risk early breast cancer. U. S. Prescriptions grew by 4% in Q2 compared to Q2 twenty twenty four, and international volume grew by 18%. Within neuroscience, Kisanda is continuing a steady launch trajectory, and we are making significant progress in driving healthcare system readiness and adoption.

In The U. S, we are seeing a strong diagnostic growth driven by PET and the acceleration of blood biomarker tests. This momentum is leading to more people being diagnosed and accessing treatment. Over 1,500 physicians and 150 of the top healthcare organizations have started patients on Keysondra. Outside The U.

S, efforts are progressing as well, with approval in 13 countries. In Europe, we anticipate approval and launch later this year, following the recent CHMP positive opinion. Finally, moving to cardiometabolic health, Moncharo and Zepan both delivered impressive performance. Moncharo posted $5,200,000,000 of global sales and exited the quarter with more than fifty percent of new type two diabetes increasing prescriptions in The U. S.

Mounjaro also became The U. S. Market leader in total type two diabetes in creatine prescriptions in July and has gained eight percentage points in total prescription share of market during the first seven months of 2025. With the recently announced positive results from SURPARS CVOT, we look forward to submitting this data to global regulators to support a labeled cardiovascular indication. Outside The U.

S, tirzepedau is now launched in most major markets. As a reminder, Mounjaro is marketed as a single brand for both chronic weight management and type two diabetes in all international markets except Canada and Japan. While the initial reception of recent launches in Mexico, Brazil, China and India has been excellent, the commercial activities have been measured to ensure demand doesn't exceed supply and that patients and physicians have a good experience. SEPAN performance was strong in Q2, contributing $3,400,000,000 of sales. SEPAN continues to be The U.

S. Market leader in the branded anti obesity market, with two thirds of total patients taking SEPAN. We recently launched the twelve point five and fifteen milligram single use vials in Libidirect. All doses of Zeppelin are not available in the vial presentation. While we work to secure broader reimbursement of anti obesity medicines, we are encouraged by the uptake of Zeppelin in vials.

The cash pay vials were approximately 20% of total U. S. Zeppelin prescriptions and over 35% of new prescriptions in Q2. As a reminder, effective July 1, the CVS Pharmacy Benefit Manager began excluding SEPAN as an offering for patients on its template formulary insurance plans. This has caused significant disruption to patients, and we strongly disagree with the decision to restrict access to medicines for patients.

As demonstrated in randomized clinical trials, incretin medicines for chronic weight management are not all the same. While it's still early, we have seen this decision negatively impact Zepbound prescriptions during July and expect it to be a headwind to the rate of volume growth in Q3. We remain confident in the long term growth outlook for SEBON as the most widely used incretin therapy in the branded anti obesity market. On Slide 10, we provide a view on The U. S.

Incretin analog market, which include prescription for both type two diabetes and chronic weight management. Q2 was another quarter of steady market growth as total prescription grew by 41% compared to Q2 twenty twenty four. Lilly performance was again strong with share of market reaching above 57%, an increase of 3.8 percentage points compared to Q1 twenty twenty five. While market growth continued to be robust, overall penetration into the addressable population is still low and we believe significantly more patients can benefit from incretin therapy. On slide 11, we provide an update on capital allocation.

Moving to slide 12 is our updated expectation for our 2025 financial performance. We are encouraged by the underlying performance we saw across the business in the first half of the year. We are increasing the bottom and the top end of the revenue range, as well as our expectation for performance margins and earnings per share. We now anticipate our revenue will be between 60,000,000,000 and $62,000,000,000 This range reflects the strong performance and a tailwind from foreign exchange rates. We will continue to invest to support our newest launches and to develop new medicines.

Given our updated expectations for revenue growth, we now expect non GAAP performance margin to be between 4345.5% as a percentage of revenue. The potential effect of tariffs remains dynamic, and we will continue to update our estimate as the situation changes. We expect the 2025 impact of currently announced tariffs to be modest, and this has been factored into our 2025 guidance range. At the bottom line, we have increased our outlook for non GAAP earnings per share and expect EPS of $21.75 to $23 As Dave mentioned earlier, we exceeded our increasing sellable doses production in the first half of the year and expect to bring more capacity online during the 2025. We expect to produce at least 1.8 times the number of sellable incretin doses in the 2025 compared to the 2024.

Now I will turn the call over to Dan to highlight our progress on R and D.

Thanks, Lucas. We've made quite a bit of progress since our last earnings call. During just the past two weeks, we shared three Phase III readouts from some of our most important molecules. I'll start with these. Last week, we announced results from the tirzepatide SURPASS CVOT trial, where tirzepatide demonstrated cardiovascular protection in a landmark head to head trial, which was the first ever cardiovascular outcomes trial comparing two incretin therapies in people with type two diabetes and cardiovascular disease.

It included over 13,000 participants across 30 countries, and it is the largest and longest study of tirzepatide to date. As shown on slide 13, tirzepatide achieved the primary objective of the study, demonstrating noninferiority compared to Trulicity with an eight percent lower rate of MACE-three events. Tirzepatide showed consistent results across all three components of the MACE-three composite endpoint. We were particularly impressed to see the rate of all cause mortality was sixteen percent lower on tirzepatide versus dulaglutide. Because this trial did not include a placebo arm, we conducted a pre specified indirect comparison analysis of matched patient level data from the REWIND and SURPASS CBOT studies.

This analysis showed that tirzepatide reduced the risk of MACE three by twenty eight percent and reduced all cause mortality by thirty nine percent compared to putative placebo. We're very pleased with these results, which show that in addition to the well established best in class weight loss and A1C control, tirzepatide now also provides a cardioprotective benefit and may provide more wide reaching health improvements, including greater kidney protection and a reduced overall risk of death. We look forward to detailed results being presented at the EASD meeting in September and published in a peer reviewed journal. We plan to submit these data to global regulators by the end of this year. The SURPASS CVOT results reinforce our enthusiasm for Surmount MMO, which enrolled over fifteen thousand participants with obesity, and will assess the impact of tirzepatide on reducing morbidity and mortality.

This is an event based study, and the rate of accrual will dictate the timing of the readout. While SURPASS CBOT and SURMUNT MMO are likely the largest randomized trials we'll conduct with tirzepatide, we'll still explore additional indications for this molecule. And we're excited to have started a new phase three trial in people with type one diabetes. Moving on to orforglipron. As Dave mentioned, today we're excited to announce top line results from our second orforglipron phase three trial, ATTAIN-one.

This trial included people with obesity but without type two diabetes. As shown on slide 14, patients in a TAIN one lost on average between 7.812.4% of their body weight after seventy two weeks, depending on the dose. At the highest dose, the average participant on orforglipron lost more than 27 pounds. And approximately forty percent of people on this dose lost more than 15% of their body weight. We also saw notable improvements on important drivers of cardiovascular risk, including non HDL cholesterol, triglycerides, and blood pressure.

Moving to slide 15, we are very pleased with the safety profile of orforglipron in ATTAIN-one. The most commonly reported adverse events were gastrointestinal, which is consistent with the GLP-one class. Discontinuations due to adverse events were low, with five percent to ten percent of patients discontinuing orforglipron across doses. Doses. There were no hepatic safety signals.

We look forward to sharing detailed results from ATTAIN-one also at the EASD meeting in September and in a peer reviewed publication. With today's readout, we've now seen results from two large phase three clinical trials involving over 3,600 participants, and we're highly encouraged with what we've seen thus far. The data from these first two pivotal studies provide evidence that a once daily oral GLP-one can achieve efficacy and safety in line with injectable GLP-1s. Orforglipron has the potential to be a more convenient alternative to injectable treatments and to be utilized to support early disease intervention in the primary care setting. With these data in hand, we're now working to move quickly towards our first regulatory submissions yet this year.

We expect results from four additional orforglipron Phase III trials over the next five months, three trials in people with diabetes from our Achieve program, and one additional trial from the ATTAIN program in people with diabetes and obesity. ATTAIN one and ATTAIN two will support global submissions for chronic weight management, which we expect in Q4. In addition to the ongoing phase three trials for orforglipron in diabetes, obesity, weight maintenance, and obstructive sleep apnea, we initiated a new program for orforglipron this quarter, Attain Hypertension, focused on reducing systolic blood pressure at thirty six weeks as the primary endpoint. This is the first study of orforglipron that includes patients with a baseline BMI as low as twenty five. We also announced plans to initiate a new phase three trial in people with knee osteoarthritis pain and overweight or obesity starting later this year.

Moving to pirtobrutinib. We announced positive results from the Bruin CLL-three 14 phase three trial of pirtobrutinib compared to ibrutinib in people with CLL, SLL. This trial included treatment naive patients as well as patients previously treated but not with a BTK inhibitor. Pirtobrutinib met the primary endpoint of response rate non inferiority compared to ibrutinib and had a nominal p value for superiority that was less than 0.05. While progression free survival data were immature, there was a positive trend in favor of pirtobrutinib.

Additional testing for progression free survival is planned as part of a future analysis. Of note, the subpopulation of treatment naive patients had a particularly pronounced progression free survival trend in favor of pirtobrutinib. This subpopulation had the longest follow-up, which is encouraging for what we might see more broadly across the total study population over time. This is second positive phase three trial to read out for pirtobrutinib as we continue to build evidence supporting the potential role for this medicine in earlier settings. We look forward to the readout of Bruin CLL-three 13, which assesses pirtobrutinib versus chemo immunotherapy in treatment naive CLL, SLL later this year.

We expect these data in combination with Bruin CLL-three 14 to form the basis of regulatory submissions globally. In addition to our recent Phase III readouts, we also have updates on several other important molecules, danenemab, retreutide, and ola moracib. For danenemab, we had three important milestones since our last earnings call. First, we were pleased to receive a positive opinion from the CHMP in The EU. We look forward to approval and launch there later this year.

Second, the modified dosing schedule was approved in The US, further strengthening the safety profile for danenemab, and we expect the modified dosing regimen to be part of the EU labeling at launch as well. Finally, we shared long term extension data from TRAILblazer ALS two, which demonstrated that over three years, danetumab treated participants showed increasing clinical benefit, despite most participants having completed treatment within the first eighteen months of the trial. In a separate part of the extension study, patients initiating dananemab after eighteen months of placebo also demonstrated disease slowing once they started dananemab. These data reinforce the value of early intervention and support the limited duration dosing approach with sustained and increasing long term benefits for treatment. For retreotide, we started a new phase three trial in chronic low back pain and overweight or obesity called TRIUMF seven.

This is our second pain study for retreotide in addition to the ongoing study in osteoarthritis pain of the knee, TRIUMF four, from which we expect results later this year. We are excited to announce plans to initiate a Phase III study in high risk metabolic dysfunction associated steatotic liver disease, or MACEL D, later this year. This trial includes both retreotide and tirzepatide, and it will utilize noninvasive tests to enroll patients who are at high risk of major adverse liver outcomes, with a primary objective of reducing the occurrence of such outcomes. This novel trial design more closely mirrors how physicians diagnose this disease in clinical practice and will enable simultaneous development of both medicines, each compared to placebo. In a prior phase II trial in MACEL D, retreutide reduced liver fat by over 80%.

And in a phase II trial in NASH, tirzepatide led to over half of patients meeting criteria for resolution of NASH without worsening of fibrosis. We believe each of these medicines has the potential to make a profound impact on this disease, and we look forward to initiating the study later this year. Moving to ola moracet, we started a Phase III trial in unresected adjuvant lung cancer. This marks the fourth indication we are simultaneously pursuing for olimarasib in KRAS G12C mutant lung cancer as part of the SUNRAY I and SUNRAY II programs. We believe olimarasib, in combination with immuno oncology agents in an early setting, could improve the standard of care for patients with KRAS G12C mutant lung cancer.

I'm also excited that through business development, we've added new molecules to our portfolio and new colleagues to our team. And it's a pleasure to welcome new team members from SiteOne and Verve to Lilly this quarter. With SiteOne, we added a new pain asset into our neuroscience portfolio, STC004, is a Nav1.8 inhibitor that's shown encouraging early data to treat pain. We believe this molecule could be an important non opioid therapy for pain in the future. Through the acquisition of Verve Therapeutics, we added several genetic medicines for cardiovascular disease that may only need to be given once in a lifetime.

The most advanced programs are VIRV-one 102, which targets PCSK9, and VIRV-two zero one, which targets ANGPTL3. And in our early phase portfolio, we advanced nisotirastide, our PYY analog agonist, into a Phase II trial in people with diabetes. And we initiated Phase I clinical trials for glucose sensing insulin, a PTK7 antibody drug conjugate in oncology, and a next generation triple agonist in cardiometabolic health. We also discontinued two phase II programs, KB1.3 antagonist for psoriasis and mazisotine for pain. And two phase I programs at Econic mimetic immunology and SCAPT siRNA in mesh.

It was a productive period since our last earnings call, and we still have an ambitious R and D agenda for the last five months of 2025. I'll now turn the call back to Dave for some closing remarks.

Thanks, Dan. We're really pleased with all the progress in Q2 across our strategic agenda. We've had another quarter of strong financial results. We continued the build out of our manufacturing footprint and advanced our pipeline, as Dan just highlighted, with external and internal R and D projects. We have good momentum as we enter the 2025, and we're focused on execution with our currently marketed products, and we're investing in the next wave of medicines that we expect will drive growth in the near and more distant future.

So now let me turn the call over to Mike to moderate a Q and A session.

Thanks, Dave. We would like to take questions from as many callers as possible. So consistent with prior quarters, we will respond to one question per caller, and we'll end the call promptly at 09:30. Please provide the instructions for the Q and A session and then we are ready for the first caller.

Certainly. At this time, we will 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. And the first question today is coming from Chris Schott from JPMorgan. Chris, your line is live.

Great. Thanks so much for the question. Just wanted to kick off with orfrogliptron. There's obviously a bit of a debate out there this morning on the weight loss profile you're showing for the product, which clearly looks efficacious, but maybe a touch below Wegovy. Can you just help put the data into context and just in general your thinking of where Orpho fits into the treatment landscape versus Zepbound and Wegovy now that you have these results in hand? Thanks so much.

Great. Thanks, Chris. We'll go to Ken to answer the question about the orfaglutron profile.

Yeah, thanks Chris for the question about orfaglutron. We're really pleased with the data we've disclosed this morning. Really the idea that you can get 27 pounds of weight loss from a single pill, and also get really encouraging effects on other important biomarkers, things like blood pressure, lipids, inflammatory biomarkers and fasting glucose. Those are a lot of the things that HCPs are really managing when they think about preventative care. Now you're getting that all from a single oral pill, but we can manufacture at scale.

We also know that simplicity matters in this space and the instructions for use here are going to be pretty simple. Take it once a day without regard to food and water. Of course, the data we're showing today are in patients with overweight and obesity, but we are evaluating orfaglutidem in a lot of other settings that includes other disease areas like diabetes and obstructive sleep apnea and OA knee pain. We're also evaluating in other contexts for the treatment of obesity. Right now we have the Attain and Maintain study ongoing, which is also testing orfagliptin as a potential maintenance therapy for patients who have lost weight on drugs like Zepbound to see whether they can keep that weight off.

So we really see a wide ranging opportunity for orfaglipron and couldn't be more pleased with the totality of the profile we disclosed this morning.

Excellent. Thanks, Chris. Next question, please.

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

Oh, great. Thanks so much for the question. Mine's actually on pricing and the pricing environment going forward. I was just hoping, Dave, you could discuss a little bit more your views on the path for price with orfagliptron and the growing number of assets coming to market. I think that's been probably the number one overhang, especially as it relates to the continued availability of compounding.

So, you know, just trying to get a better understanding of of where you see price going and maybe if you can provide some thoughts on compounding in that context and how you maintain tirzepatide compounding off market when it's being ignored with semaglutide. Thanks so much.

Thanks, Seamus. Dave, we'll go to you talk about the broader pricing environment and potentially weaving in some compounding commentary.

Okay. Yeah, thanks, Seamus. You know, as it relates to compounding, let me just deal with that first. You know, we've always been concerned about this because of the patient safety, risk that exists. Every day we get calls from patients concerned that they are getting ill on a medicine they think is ours and it's not.

This, of course was allowed during drug shortage, there's no drug shortage. And we really think that regulators and law enforcement officers in The US need to step up their game, to really eliminate this. That's why we have an FDA and a structured regulatory process in The US. And so we want to see that end mostly because people are being harmed. We see robust growth in the marketplace in The US, 42% total incretin growth over last year, good sequential growth.

And of course, Lilly's growth is more than double that. So the business is fine, but, people shouldn't be harmed. That said, I think on pricing, we've always had a philosophy across all medicines, including with incretins to price to value. And given the profile we present, to consider offsetting other healthcare costs including medicines, the value to the patient, the value in the economy as well. And here with GLP-one and incretin mechanisms we're seeing profound value, frankly.

So, we're noticing a difference in, when we offer consumer level pricing outside of insurance. But inside of the healthcare system, which is most of the business, we think that we'll expect single digit erosion like we do other chronic medications in net pricing while maintaining, a value point on lists that makes good sense. That's not considering any new policy environment, but that's our philosophy going forward. So as we have a suite of products with some with, perhaps more value in patients with more complicated, obesity, or those that, maybe have less complicated obesity but medicines like oforglipron that could reach the masses, of course we'll consider those factors in price setting at the list level, and then the net will find its level, in negotiations. And you can continue to expect Lilly to offer consumer level pricing as long as we have such a large hole in coverage, in our country for important chronic disease like obesity that should be covered. Those are our views on pricing.

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

Great. Morning, guys. Thanks for the question. Dan, on Orfagliptron, looking at discontinuation rates, looks competitive for ATTAIN and ACHieve. But can you talk about how the GI adverse event rates change over the course of the studies?

And were there common futures among those with the highest adverse event rates? Obviously thinking how this could play out from a commercial context. Thank you.

Thanks, Jeff. Dan, we'll go to you to talk about some of the ORFO GI profile over time.

Yeah, thanks, Jeff. No surprises in there. The GI profile was as expected for a GLP-one agonist, which is to say that most of the side effects occur early in the treatment course or with dose escalations, and then they go down over time. In terms of any specific patient characteristics that predicted, I don't believe we saw that in the study, nor have we seen that in prior studies with GLP-one. But really, no differences here that we thought were noteworthy versus monotherapy GLP-one injectables. Great.

The next question will be from Tim Anderson from Bank of America. Tim, your line is live.

Thank you. I wanted to ask kind of a compounding question in a way, I guess. Canadian generics for Novo's semaglutide, they're likely to launch in early 'twenty six. I think everyone can agree that tirzepatide is a better product. Won't this still cause a lot of trouble in the market there's a big cash pay channel and where we already know that patients are proving themselves to be price sensitive and willing to use a lesser product like a knockoff semaglutide?

Seems to me Canadian generics are just a replacement for that compounding channel, and they'll keep that headwind alive even if compounders get shut down. And we're talking about a product here that will have gone through a regulatory review cycle, not by FDA, but by another regulator. So with that launch six months away, is that a headwind that we should expect may continue? Thanks.

Okay. Thanks, Tim, for the question on the Canadian generics impact. We'll go to Ilya to answer that one.

Yeah. Thanks for the question. Maybe I'll touch on what we're currently seeing in The US market. And if you assume looking at the self pay market that what we're seeing in vial performance and overall market is continuing to grow at rapid pace. We're seeing that our offering with the vial with setbound and the profile that we have with setbound is meeting a need for patients, even in the context of noise, whether you have compounded or semi in market.

You take a look at just the growth that we've seen in Q2, we've generated over 1,000,000 TRX in vial in Q2. And we recently launched last week, the highest doses of vial available for Zepbound. And we're continuing to see health in that market. Roughly 20% of all of our TRx is coming from the cash pay market and continue to see strength overall, both in self pay and covered. We're seeing around 65% share market in new therapy starts for ZBound overall.

So we see health in the market and where ZBound provides a greater value.

Great. Thanks, Ilya. We'll go to the next question, please.

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

Yes, thanks very much. So I was hoping to better understand the evolution of US employer coverage for anti obesity medicines and the prospects. So my understanding is that coverage has been pretty flat on a net basis over the last eighteen months, let's say since January '4, meaning the net covered lives has been flattish. If you can confirm that that's correct. And then can you talk about the outlook for the net change in U.

S. Employer coverage for anti obesity medicines over the next six months or so for January '6? Thanks very much.

Great. Thanks, Dave, the question. We'll go to Ilya to talk about the progress in the debt bound employer coverage, Optin.

Sure. Thanks for the question, Dave. You know, as we take a look at employer coverage, it's important for us to grow coverage over time. What we've seen in different offerings across the different plans, some are more complex than others, and we've seen an increase overall but it has been steady around 50% to 55% employer opt in coverage. At the same time, we are seeing new benefit designs like for instance, EverNorth's a cap on out of pocket for employees that make the prior authorization or simplified and that may grow employer opt ins over time.

That's something that we're working through. Our outlook is that as evidence grows and we find new ways and also different plan designs are available to different employers that that will continue to do.

Great. Thank you, Ilya. We'll go to next question, please.

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

Great. Thanks for taking the questions. Congrats on all the progress. Just wondering on orfagliptron in light of the ATTAIN-one data, if you can just frame expectations for us, Dan, for the upcoming ATTAIN-two Phase III data? And then any early insights into the potential CMMI obesity Medicare Medicaid pilot that I think we saw some press reports about?

Thank you. Okay. For that we'll go to Ken to answer the question on expectations for ATTAIN-two.

Yeah, thanks, Terrence, for the question on ATTAIN-two. You know, we're very pleased with what we disclosed this morning in ATTAIN-one, which is our first phase three study in obesity without diabetes. And of course, we had a great result with Achieve one in patients with diabetes. So as we look ahead to ATTAIN-two, we expect similarly encouraging results. The exciting thing about ATTAIN-two is that be our third phase III study and it sets us up to submit in obesity by the end of this year.

So really no change in expectations here. The team is full speed ahead preparing for submission by year end and a potential approval next year. Great.

And if you want to hop back in the queue, Terrence, we'll see if there's time for your second one. Next question, please.

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

Eli Lilly (LLY) Q2 2025 Earnings Call Transcript

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