Eli Lilly and Company

Good morning. Thank you for joining us for Eli Lilly and Company's Q2 2026 earnings call. I'm Mike Czapar, Senior Vice President of Advice to 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, Adrian Brown, President of Lilly Immunology, Dr. Carol Ho, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly USA and Global Customer Capabilities, President of Lilly Oncology and Head of Business Development, Patrick Johnson, President of Lilly International, and Ken Kuster, President of Lilly Cardiometabolic Health. During this call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to various 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 and subsequent filing with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional or otherwise influence prescribing decisions. Our commentary today will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave.

Thanks, Mike. Q2 continued Lilly's strong momentum. We delivered robust revenue across all key products and major geographies. We raised our full year annual guidance We advanced our pipeline across each of our therapeutic areas and expanded our pipeline through business development. On slide five, we list key Q2 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 48% compared to Q2 of 2025, and our key products increased by almost $6.8 billion. Within key products are oncology, Immunology and Neuroscience Medicines collectively grew 121% compared to the same quarter last year as we continue to expand our presence across the portfolio. The number of people taking Incutins grew and Lilly's portfolio of medicines extended its leadership position. The U.S. Foundeo launch continued to build momentum after educating physicians and securing commercial access across all three major PBMs in June We began broad, direct-to-consumer marketing to raise consumer awareness. We completed the U.S. submission of Foundeo for type 2 diabetes and expect regulatory action later this year. We launched Foundeo for obesity in the UAE and we recently received approval in Saudi Arabia for obesity and in Mexico for obesity and type 2 diabetes. Early uptake in the UAE has been encouraging. demonstrating the pent-up demand for Foundeo to treat obesity outside the U.S. Foundeo is under regulatory review in over 40 additional countries, and we look forward to additional approvals later this year. We also achieved several key pipeline and regulatory milestones since our last call, including the U.S. FDA approval of Eblis for maintenance dosing once every eight weeks in atopic dermatitis, The EU approval for J-PERCA in CLL across all lines of therapy. A positive CHMP opinion in EU for insulin F-sitora-alpha for type 2 diabetes under the trade name Onswik. And positive top line results in three phase three retritutide trials in obesity. We added to our strong internal pipeline through business development, announcing agreements to acquire multiple companies to expand our presence in emerging therapeutic areas, including Kirovo, Limitech Biologics, and the Vaccine Company, building a platform of potential new medicines to prevent infectious disease and their downstream complications. And we acquired Atai Berk-Beckley, a company developing novel treatments for treatment-resistant depression and other mental conditions. We continued our manufacturing build-out and opened our first dedicated genetic medicine manufacturing facility in Lebanon, Indiana. We also produced the first batch of commercial material at our new manufacturing site in Limerick, Ireland. We distributed $1.5 billion in dividends in the second quarter and executed $1.6 billion in share repurchases. Lastly, in partnership with the US government, we reached an important milestone to improve Medicare access to anti-obesity medicines. As shown on slide 6, the Medicare GLP-1 Bridge Program launched on July 1, granting 20 million eligible Americans insurance coverage for GLP-1s for obesity at the low, out-of-pocket price of $50 per month. With this expansion, 35% more people now have coverage for our obesity medicines in the United States. While still early, feedback from patients and physicians has been quite positive. will soon be publishing our annual sustainability report at sustainability.lilly.com, showing the progress we made in 2025 on our sustainability priorities. Notably, we reached approximately 40 million people in resource-limited settings, exceeding our original goal of reaching 30 million by 2030. We are now developing a new commitment to address the growing burden of diabetes and obesity in resource-limited settings worldwide. and we'll share more details about this plan later this year. Now I'll turn the call over to Lucas to review our Q2 results.

Lucas Montarce Thanks, Dave. As shown on slide seven, Q2 was another strong quarter of financial performance. Revenue grew 48 percent compared to Q2 2025, driven by Seppan and Moncharo, with strong momentum across all areas and geographies. Gross margin as a percentage of revenue was 86.3 percent in Q2, An increase of approximately 1.3 percentage points versus the same quarter last year. The change was driven primarily by favorable product mix and improved cost of production. Marketing, selling, and administrative expenses increased 25% as we invested in promotional activities to support current and planned product launches. R&D expenses increased 14% driven by continued investment in our pipeline, including more than 40 active phase three programs. Our non-GAAP performance margin was 54.8%, an increase of nine percentage points from Q2025, driven by revenue growth. Non-GAAP earnings per share were $8.38, including acquired IPR&D charges of $3.03. This compares to earnings per share of $6.31 in Q2 2025, inclusive of $0.14 of acquired IPR&D charges. On slide eight, we quantify the effect of price, rate, and volume on revenue growth. U.S. revenue increased 33% in Q2, primarily driven by volume growth at Banan Moncaro, as well as contributions from our immunology, oncology, and neuroscience portfolio. U.S. price declined by 3%, driven by Zeban and Monjarro. In Q2, U.S. price benefited from a change to estimates for rebates and discounts. Excluding these adjustments, U.S. price declined by 9%. Europe revenue grew 55% in constant currency, driven by sustained strong volume growth of Monjarro. Europe revenue also benefited from a $250 million Jardian milestone payment. In Japan, revenue grew 30% in constant currency, driven by Monjaro and Kizonda. In China, revenue grew by 93% in constant currency, driven by the uptake of Monjaro. And in the rest of the world, revenue grew 136% in constant currency, driven by Monjaro, primarily in Latin America and Asia. On slide nine, we provide an update on the performance of our key products.

Within Immunology,

Eptly's worldwide sales more than doubled compared to Q2 2025. In the US, Eptly's continued to gain share of new prescriptions, increasing by approximately four percentage points in the specialty dermatology market since last year. In oncology, Jaipirka had another strong quarter of growth, and worldwide sales increased 56% compared to Q2 2025. As we continue to generate positive clinical trial data and expand the label, We believe Jypica has the potential to be a foundational therapy across multiple settings and regimens within CLL. Inlurio continued strong uptake in the metastatic breast cancer oral cert market. After only two full quarters, Inlurio in the U.S. is leader in new prescriptions with more than 50% share. We look forward to the readout of EMBER IV in the adjuvant setting to see if InLureo can help even more people with breast cancer. In neuroscience, Kisonla posted strong revenue growth, expanding its leadership position in the U.S. anti-amyloid target therapy market. Diagnostic testing momentum also continued to build, and the number of PTAL 217 blood tests more than doubled compared to Q2 2025. This is translating to more people being diagnosed with Alzheimer's disease and accessing treatment. Outside the US, solid performance in China and Japan contributed to growth as well. Finally, in cardiometabolic health, Monjaro and Zepan had another strong quarter combining for $14.9 billion of revenue and contributing $6.3 billion of growth compared to Q2 2025. As seen on slide 10, Total prescriptions in the US, incretin analog market grew 31% compared to Q2 2025. The early uptake of oral GLP-1s has been encouraging, expanding the market of people who are taking incretin therapy. Additionally, injectable incretins continue to be an important growth driver and account for three out of four new patient starts. Within the US, Incretin Analog's obesity market total prescription grew by 78% in Q2, and the Lilly anti-obesity portfolio continues to lead. In Q2, approximately 6 out of 10 total prescriptions and approximately 7 out of 10 injectable prescriptions were for a Lilly medicine. Self-pay continued to be an important segment within obesity. and accounted for approximately 45% of total separate prescriptions in Q2 and approximately 55% of new prescriptions. In the US, type 2 diabetes incretin analogs market, total prescriptions grew 9% compared to Q2 2025, reflecting a more mature market compared to obesity. The Lilly portfolio continues to lead here as well, as more than six out of 10 prescriptions for an incretin were for a Lilly Medicine. Outside the US, Lilly's portfolio is also performing well in the incretin analogs market. Slide 11 shows aggregate trends in the international incretin analogs market, which has increased by 74% since the same period last year, as measured by IQ via gross sales. Lilly is the global market leader. and we strengthened that position, gaining almost two percentage points of share compared to Q1 2026, reaching approximately 55%. Monjaro Q2 revenue growth was robust, driven by China, Korea, Germany, the UK and Mexico. We expect continuous strong performance outside the US, but with market share leadership already established, market expansion will be key to driving sustainable growth. We also saw incremental progress on securing reimbursed access as Monjaro is now reimbursed for both type 2 diabetes and obesity in France. Slide 12 provides an update on the FONDEO launch and the cadence of anticipated upcoming catalysts. The U.S. launch is progressing well. Total prescription and share of new patients continue to grow. as we are increasing our investment to drive brand awareness among physicians and consumers. The recent launch of the Medicare GLP-1 Bridge Program is an opportunity to expand the oral market, unlocking access for eligible seniors with a low out-of-pocket cost. We are pleased to receive the first international approval for obesity in UAE and Saudi Arabia, and in Mexico for obesity and type 2 diabetes. We look forward to potential approvals in additional markets this year. With more than 40 markets currently under regulatory review, we expect a global rollout in all major markets in 2027. We also expect readouts of many additional clinical trials. The first readout in obstructive sleep apnea will come later this year, and we have an additional five ongoing phase three programs staying for now. As a small molecule that can be produced at scale, Condeio has the potential to help millions of people improve their cardiometabolic health. Moving to slide 14, we provide an updated 2026 financial guide. We have increased the low end of our revenue range by $3 billion and the high end by $2 billion, reflecting a strong underlying performance of our key products in the first half of 2026. We now expect full year revenue to be between $85 and $87 billion. Based on higher revenue, we now expect our non-GAAP performance margin to be between 49% and 50.5%, an increase of two percentage points at the low and the high end of the performance margin range. We now expect non-GAAP earnings per share of $35.50 to $36.50. An increase of $2.78 per share at the midpoint of our range before updating our guide for the $3.03 impact of Q2 acquired IPR&D charges. We are pleased with our Q2 results and confident in our ability to deliver another year of industry-leading 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 across R&D with advances in each major therapeutic area. I'll begin with cardiometabolic health. Starting with Reta-Trutide, we announced positive results from three phase three trials. TRIUMPH-1 in people with obesity or overweight, TRIUMPH-2 in people with type 2 diabetes and obesity or overweight, and Triumph 3 in people with severe obesity and established cardiovascular disease with or without type 2 diabetes. Across the Triumph program, we've seen profound levels of weight loss and improvements in A1C, cardiovascular risk factors, osteoarthritis pain and sleep apnea. With the recent completion of Triumph 2 and Triumph 3 trials, We now have the clinical data package to support global registrations in obesity, obstructive sleep apnea, and knee osteoarthritis pain. Slide 15 shows impressive and consistent weight loss across the Triumph registrational program. In Triumph 1, we saw weight loss approaching bariatric surgery levels at the highest doses and clinically meaningful efficacy at low doses with only one titration step. In patients with diabetes and obesity, who typically struggle to lose weight. Retatrutide delivered a magnitude of weight loss not previously seen with incretin therapy. We look forward to working with regulators as they evaluate this important new medicine and plan to submit in the U.S. in quarter one, 2027 under the BLA pathway. Turning to Orforglipron, we have completed our U.S. submission in type two diabetes supported by the Achieve phase three program. In June, we presented detailed results from three of those trials, ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 at the American Diabetes Association Scientific Sessions. ACHIEVE-3 was the first head-to-head comparison of two oral GLP-1s, and Orfaglipron delivered superior glycemic control and weight reduction against 7 milligrams and 14 milligrams oral semaglutide in patients with type 2 diabetes. For the many people with type 2 diabetes who prefer an oral option and have difficulty reaching their glycemic targets, we believe Orforglipron has the potential to be a foundational daily oral treatment. Also in cardiometabolic health, the CHMP adopted a positive opinion recommending EU approval of insulin F-Cytora Alpha for patients with type 2 diabetes. The opinion was based on the phase three program, where once weekly insulin F-sator alpha achieved reductions in A1C comparable to those of once daily basal insulin. For people with type 2 diabetes who require insulin, a single weekly injection can simplify treatment and ease the burden of daily dosing. We look forward to European approval in the coming months. We also shared clinical results from VRV-102, our gene editing program in cardiovascular disease, designed to inactivate the PCSK9 gene, resulting in lowered LDL cholesterol. In the Phase 1b study, the single infusion reduced PCSK9 by 88% and LDL cholesterol by 62% at the highest dose. These early data are encouraging and suggest that we may be able to have a medicine delivered once, lasting cardiovascular benefit. Moving to neuroscience, we announced an agreement to acquire Ty Beckley, which is advancing a pipeline of rapid-acting neuroplastigens for treatment-resistant depression and other mental health conditions. The lead asset, BPL003, has shown encouraging Phase IIb results. This remains one of the most significant unmet needs in psychiatry, and we're encouraged by the potential of a rapid-acting therapy designed to deliver durable relief. We look forward to welcoming the Ty Beckley team to Lilly. With the Sintesa acquisition now complete, we added clemenorexin to the pipeline in Phase 2. Clemenorexin is the potential best-in-class orexin receptor 2 agonist being studied in a Phase 2-3 trial in central hypersomnia. Orexin biology plays an important role in regulating the sleep-wake cycle, and sleep disorders are associated with many neurological, neurodegenerative, and neuropsychiatric conditions. We believe with the Sintesa pipeline, We may have the potential to treat a broad range of diseases. Turning to oncology, we recently presented detailed Phase III results from Bruin CLL322 at the 2026 EHA meeting, which added pertabrutinib to a time-limited venetoclax and rituximab regimen in previously treated CLL. As shown on slide 16, in the overall study population, adding pertabrutinib reduced the risk of disease progression or death by 45% compared to the fixed duration regimen. Additionally, in patients whose disease progressed after treatment with one prior covalent BTK inhibitor, adding pertabrutinib to the fixed duration regimen led to a 68% reduction in the risk of progression or death. These results are the first to outperform a venetoclax-containing control arm in a CLL Phase III trial. We believe this study has the potential to establish a new standard of care in this population, and we've submitted these data to global regulatory authorities. Also in oncology, we shared impressive new data from the Libretto 432 Phase III trial of selprocatinib in adjuvant RET fusion-positive non-small cell lung cancer. These results were presented during the plenary session at the 2026 ASCO meeting. and showed that selprocatinib reduced the risk of disease recurrence or death by 83% versus placebo. This striking effect size highlights the efficacy that can be achieved by targeted therapies and underscores the importance of comprehensive biomarker tests across all stages of disease. We were also excited by the encouraging data presented at medical meetings from two recently acquired hematology programs, AJ1-11095 the Type 2 JAK inhibitor from AJAK Therapeutics, and KLN 1010, an in vivo CAR-T therapy from Colonia Therapeutics. Both programs demonstrated compelling early efficacy and safety, and we look forward to progressing both through clinical development alongside the teams from AJAKs and Colonia. Moving to immunology. The FDA approved a new maintenance dosing regimen option for Leberkizumab, giving patients with atopic dermatitis The option to manage their condition with as few as six maintenance injections per year. The potential to deliver sustained disease control with greater convenience has been well received by physicians and patients, reinforcing the strong and durable effect of Leberkizumab. With our partner Amaral, we're exploring even less frequent dosing once in 12 weeks. These data are expected in 2027. We're also working to bring Leberkizumab to more patients. Based on the positive phase three results in children six months to 18 years old in the adorable trial program, we submitted for a pediatric atopic dermatitis indication in the US and plan to submit to other global regulators later this year. We also continue to expand our study of incretin biology into new settings and initiated two phase two trials of Bernapetide, our GIP GLP-1 dual agonist, in irritable bowel syndrome. Irritable bowel syndrome is a disorder of gut-brain interaction defined by heightened visceral pain sensitivity and disordered intestinal motility. Incretin pathway signaling has been shown to reduce visceral pain sensitivity, modulate gut motility, and help restore the intestinal barrier. We also began a phase two trial of our FXR agonist in combination with miratizumab in Crohn's disease. and a phase two trial of our XCL12 antibody in vitiligo. Finally, we announced three of global morbidity. New medicines could be important to prevent acute disease and the downstream long-term consequences. We believe that combining these companies' platforms and teams with Lilly's global scale could position Lilly to address significant population-level health problems. The acquisitions include Curevo, adding imizovatian, a potential next-generation varicella zoster virus vaccine for the prevention of shingles. In phase two head-to-head study against the current standard of care, imizovatian showed a comparable immune response with meaningfully improved tolerability. With growing evidence linking shingles to elevated stroke risk and shingles vaccination to reduce dementia risk, a better tolerated vaccine could extend reach of shingles prevention and reduce long-term risks of dementia and stroke. Next, Limitech Biologics is developing vaccines to prevent serious bacterial infections. Its platform focuses on bacteria by targeting the toxins and super antigens that drive disease. The most advanced program is in phase one, the prevention of the leading bacterial cause of surgical site infections, where no vaccine exists today. Vaccines to prevent bacterial infection could play an important role as antimicrobial resistance grows globally. And finally, Vaccine Company, which has a lead program against Epstein-Barr virus, an infection with no vaccine today. Beyond acute mononucleosis, Epstein-Barr is linked to chronic oncological and neurological sequelae, including multiple sclerosis. A vaccine could prevent not just the infection, but the serious diseases that follow it. As highlighted by all the new molecules we added to our pipeline through acquisitions, business development is an important component of our R&D strategy. In the first half of 2026, we made strong progress and announced deals to acquire potential new medicines across established and emerging areas at Lilly. We've been increasingly active in business development over the last several years. The pace and average deal size have also continued to increase, reflecting our strategy to grow within our core therapeutic areas and create new opportunities through emerging science. Lilly is uniquely positioned to pursue diseases where they're significant on that need, exciting early science and the need for Lilly's development Regulatory and Manufacturing Scale to Create Value. We expect to remain active in business development while maintaining discipline to create value. Finally, slides 18 and 19 show the pipeline movement since our last earnings call and the full list of potential key events expected in 2026. It was another productive quarter at Lilly R&D, and we have an ambitious agenda for the second half of the year. I'll now turn the call back to Dave for closing.

Thanks, Dan. We made excellent progress this quarter. We delivered strong business results, received regulatory approval for new indications, shared positive Phase III trial results, added new medicines to our pipeline, and expanded access to medicines for patients. While we're pleased with the progress this year so far, we're not satisfied. We remain focused on executing the three components of our strategy to deliver sustained, long-term growth. to broaden our impact on cardiometabolic health, expand our presence in other therapeutic areas, and invest to drive future growth. Now I'll turn the call over to Mike to moderate the Q&A session.

Thanks, Dave. As a reminder, we would like to address as many questions as possible, but consistent with the prior quarters, please limit yourself to a single, one-part question. Paul, please provide the instructions for how to join the queue, and we're ready for the first caller.

Thank you. At this time we will be conducting a question and answer session. If you have any questions, please press star 1 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 1 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. And the first question today is coming from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Oh, thanks so much for the question. So I really wanted to ask on just sort of the increasingly deep position that Lilly is driving with consumers and how you envision expanding that treatment opportunity going forward. There's a number of different approaches that one could see Lilly taking across a more aesthetic-driven approach, but where do you see this consumer market evolving? And if you could, just maybe give us a sense of how unique or similar the U.S. versus the international self-pay market is at this point in time as you see it. Thanks so much.

Great. Thanks, Seamus. Some context on the consumer expansion. We'll first go to Ilya to talk about the U.S. and then Patrick can add some commentary about what we see outside the U.S. Sure.

Thanks, Seamus. And, you know, I think the overall market, if you think about just obesity in general in the U.S. and globally, we're still have single, mid-single digit in terms of utilization or treatment of obesity. And so there's still a significant opportunity ahead of us to capture more patients. In terms of access, you see a meaningful improvement in access with Bridge as well as in state Medicaid access going live or committing to next year. We continue to see significant growth even in Q2 in overall TRX coming in to treatment of obesity on 3 million TRX. A lot of that is driven by both injectable and oral on new patients coming in. And of course, we're seeing about 55% of overall prescriptions for ZEP-bound being in self-pay. And so we continue to look for ways to increase access and affordability, increase the consumer awareness. And so we're putting a lot of efforts on for consumer awareness and building out the need and urgency to treat obesity. And we continue to look for ways to expand our early direct offering and make it easy for people to get access to care. Patrick?

Thank you. When we look at the obesity business outside of the U.S., it's still mainly out of pocket. So I think the consumer activation here is playing a significant role. and we have rapidly been replicating some of the practices from the U.S. outside of the U.S. as well. And we have launched versions of Lilly Direct outside of the U.S. However, it's important to take into account that regulations OUS differ and so will be different models that we will apply. But we will move quickly in this space. And I think they have one thing in common and that is to make sure that patients are being reached by safe and authentic Lilly medicines and we'll continue to lean in on those efforts.

Great. Thank you both. We'll go to the next caller, please.

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 the continued strong performance and execution. Maybe just on the Fondeo launch, in the U.S., the launch curve has been somewhat slower than anticipated. Just curious as to what you think the contributing factors are there and when you think we could expect an inflection. and then on OUS, just curious to hear any updated thoughts on how you're thinking about competitive dynamics and the launch trajectory. Novo is now also scaling launches for their oil bill in several key ex-US countries such as the UK and Germany and in the UAE, I know you said you were encouraged by the early demand but any learnings in terms of share dynamics now that Novo is in that market too and they said this morning that they got 50% share within three weeks of launch. Thank you.

Great. Thanks, Asad. We'll stick with the same deal here. Ilya, you want to start with talking about progress in the U.S. Foundeo launch, and then Patrick, you can add some color on ex-U.S.?

Sure. Thanks, Asad. So, you know, listen, for Foundeo, we're making pretty meaningful progress on the Foundeo performance and building out the brand. As we said from the start, we're focusing on three key areas. One is making sure we educate physicians on the Foundeo profile and building out that experience. The second is really achieving greater access and affordability for Foundeo. And then the third is building out consumer awareness. And we're making progress on all three fronts. So we're seeing the leading indicators being pretty positive overall. We're seeing week-to-week growth in overall prescriptions and uptake for Foundeo. And with building out, just if you take a look at the last 30 days, we've increased access with CVS, adding Foundeo in June. We've obviously, you've seen the launch of Bridge happening July 1, and we started the launch of our full DTC promotion campaign from there to build out consumer and physician awareness. And what we've seen in terms of overall growth and inflection is that the last week of July, we're seeing inflection. So the... almost doubling the volume that we had just a month ago. And we're starting to see new starts coming in nearly around one out of four starting on Foundeo. So we're starting to see an inflection point on Foundeo now and we continue to access growth and overall kind of HCP adoption. We believe that we'll continue to see growth in Foundeo over the coming quarters.

And OUS, when we looked at the first launch, we launched in UAE early May and we actually had a strong start and with early signals showing that orals are expanding the market. And similarly to the US, we see that most patients are actually naive to treatment with incretin. And patients are titrating up steadily. And when we look at the Lelius combined, incretin share held steady even if we had a second oral entering the market. When we look ahead, we have the approval in Mexico and Saudi and those are the markets where we will launch next. And most of the launches will come in 2027. But I think we are extremely well positioned here in terms of supplies. There will be no gating of launches either. Just in general, we need to have in mind that this is very early data, and there is a lot of noise in the data set. So I think when data are being referred to, it's very often sell-in data, and that takes into account all of the dynamics within Ventura Build. But on our side, very pleased with the start of the launch of Fondeo outside the U.S. Great.

Thanks both. Next question, please.

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

Lilly Thien, thanks so much for taking the question today. I did just want to probe on the Red or True Tide regulatory pathway. Dan, I noticed you mentioned kind of the BLA pathway, and I know that you've been negotiating perhaps challenging the FDA over the last couple of years in terms of that determination as to whether Red or True Tide meets the criteria for a BLA. Can you just help us understand the requirements and milestones ahead in ensuring that this is accepted as a BLA and anything that kind of will help us understand whether this is going to be unique to Reddit True Tide or whether there are going to be subsequent incretins that are going to be able to get classified as a BLA going forward. Thank you so much.

Thanks, Courtney. We'll go to Dave to talk about the Reddit True Tide filing pathway.

Yeah, thanks, Courtney. as you mentioned we've been pursuing this for a little while because we believe Retrotutide is a biologic application both in terms of amino acid count rule as well as analogous to a protein so that's our position there was a mixed decision in the first decision in the courts obviously it's active litigation but we would hope to come to a conclusion with the FDA to support a BLA application as you may know we have announced at the end of our clinical program that we have all the clinical data we need to submit We do need to gather a little bit more on the CM&C side. While that's going on, you can bet we're in communication with the agency and we'll give an update to investors as there's any progress on the filing status for regitutide. But super exciting data package. I think we're seeing really unprecedented efficacy with this triple acting GLP-1. We have a pretty large lead over any competitors with a triple acting medicine. and we pursued a very interesting, I think, package of comorbidities in both the initial package and now in subsequent data that we'll read out over the coming year or so. So very excited about the program and look forward to the submission by Q1 next year.

Great, next question please.

And the next question will be from Chris Schott from JP Morgan. Chris, your line is live.

Great, thanks so much and congrats on all the progress. I know it's early, but can you just elaborate a bit more on the Medicare obesity rollout and any learnings and surprises there thus far? Maybe as part of that, can you just touch on the ramp curve we've seen initially, what you're seeing in orals versus injectables, et cetera, just trying to get a sense of how you're feeling this is going so far. Thanks so much.

Great. Thanks, Chris. We'll go to Ilya to talk about the Medicare GLP-1 bridge rollout and any context on orals versus injectables.

Great, thanks, Chris. You know, we're really excited about, one, expanding access for seniors in the U.S., as David mentioned in the early part of the call, that it's increasing access to about 35% more Americans being able to access obesity therapy. If you think about the start, it's still early days. At the same time, we're seeing a pretty significant inflection point. You know, we're closely on, with CMS on educating physicians and different stakeholders, pharmacies, on the criterion process. That process is working pretty well in terms of the prior authorization and approvals of people that qualify. And so the criteria are clear. We're continuing to do pretty extensive education across consumers, physicians, and pharmacies to understand the criteria so that they know whether or not they can benefit. and we've also enabled Lilly Direct to fulfill on the Bridge process. And in terms of momentum, you can see an inflection point for both of our medicines, ZetBound and Founday, over the last few weeks. Part of that is Bridge. The approximate, we're seeing a significant preference towards injectable, probably around 80% of people that are getting treatment are injectable, but we're seeing new patients for both. And we approximate around 60% to 70% being new people that are coming in that have not had access before. So it's still early days, but we're encouraged by the inflection point over the last few weeks, and we'll continue to work on educating consumers and stakeholders on the benefit of the BRIDGE program.

Great. Next question, please.

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

Good morning, everyone. Thanks for the question. I also wanted to say congrats on the quarter. I had two related ones on Reta Trutide. The first one is, do you need a commercial strategy to protect against whatever it is that's apparently available today, or will that solve itself with formal approval? And then related, you guys have expanded the indication base for terzapatide well beyond With the higher efficacy of Reta-Trutide, are there additional indications that you can now address that otherwise perhaps you couldn't? Thank you.

Great. Thanks, Jeff. We'll go to Ken to talk about the development strategy on Reta-Trutide and then any comments about, you know, commercial strategy as well.

Yeah. Thanks for the question, Jeff. First of all, I think people are eagerly awaiting authentic Reta-Trutide to be available in the market and we fully expect that when we get this to medicine to market, people will vote with their feet and embrace the really guaranteed product. In terms of development strategy, what we do have a broad base with Terzapatide of indications with RETA we're seeing in terms of really transformative weight loss at the high dose. And it does open up additional opportunities. You've seen that with the data we've shared on osteoarthritis, knee pain, both from Triumph 4 and Triumph 1, where you're effectively reducing pain by unprecedented amounts, 75%. I think that's exemplary of the sorts of opportunities we have ahead with this molecule. We're also advancing it in a study in MASH or Masl-D, which is ongoing and then which We think the glucagon mechanism of action there offers some potential unique opportunities. But we're also evaluating several additional indication opportunities here internally and may have more to say in the future on that. Last, I'll circle back to pain. We also have a chronic lower back pain study ongoing with RETA, which you'll read out sometime next year. So overall, very exciting medicine that we think can do a lot of work in the treatment of obesity, both on the high end with bariatric surgery like weight loss and on the low end with just the simplicity of a single titration step. We'll look to expand the indication set and really maximize this opportunity. Great.

Next question, please. 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 and congrats on the progress. I'll ask a non-increditing question for extra credit.

So, for breast cancer, I would love to understand how you are thinking about the post-fertilizer strategy in breast cancer at this point. You have SARD, you also have oral VIH-3K, so is there and all oral combo on the table as well. Thank you.

Great, thanks Mohit and extra credit duly noted. Jake, we'll go to you to talk about the breast cancer strategy after Fresenio.

Yeah, thanks Mohit for the question. We're really excited about the presence that we have in breast cancer historically and going forward. I think the three most important targets in breast cancer are the estrogen receptor, CDK4-6 and PI3 kinase alpha. We think we have The Best Medicines for Every Single One of Those Targets, and we have plans to combine them all. You know about what we're doing with Imunestrant, currently an approved product as in Lurio, with Ember 4 slated to read out next year, the badge of a trial that is a major moment for that medicine. And, you know, we're on the precipice of beginning the Phase 3 program for Tersolisa, the PI3-kinase-Self-Inhibitor, which will be initially combined with existing endocrine therapies, but over time... we envision absolutely combining in LIRIO and even in the existing study will be combined with investigators choice of CDK4-6, a large part of which I think will be for Xenio. So we're really excited about the potential for that all oral combination in a variety of settings down the road. Thank you.

Great, next question please.

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

Hey, thanks so much.

So it seems like your guidance is almost implying a deceleration in REVs versus Q2 for the back half of the year, and that seems unlikely given the Medicare Bridge programs ramping up along with Foundeo commercial access getting online. Is there anything we're missing here maybe on price, or is your team generally trying to be conservative here? Thank you.

All right, thanks, Akash. We'll go to Lucas to talk about the moving parts and guidance.

Thank you, Akash, for the question. Maybe a few parts. Very pleased, by the way, to continue to see the strong performance that we see, not only in the first half of the year, but also upgrading the guide by $2.5 billion for the full year. To your point about what are the ins and outs on the guide, I think it's worth to highlight in the last couple of quarters that there were a few one-offs that we call it out in the calls as well, period adjustments that we have on our estimates for rebates and discounts in the U.S., including this quarter. Those, of course, we don't expect that will continue into the second part of the year. So that's something that once you look at the models, it's important to factor that. Then you mentioned the comparison in terms of growth versus last year. What is important, if you look at the base period, the 2025 period, Remember that in the second part of the year, basically, we had all the bolus of the launches of Monjaro in all U.S. markets. That was basically adding a lot of, again, new countries and volume into the second part of the year. When you look at actually the growth that we expect to see in dollars, not in percentage of growth, we expect to continue to drive significant growth in the second part of the year as well. of course again that bolus of new countries as all along I highlighted has already happened will not happen again and as Patrick alluded as well the growth that we expect to see in the future is more driven by the penetration in the OUS market so those are some of the factors that is important to highlight last but not least again I know that some of you are fans of the seasonality effects and I think it's worth to highlight that as well we always have the seasonality in Europe in Q3 with all the vacation holidays taking place and that's factored in our guide. And usually we have some seasonality in type 2 diabetes in the U.S. in the fourth quarter. So those are some of the one-offs that I think is worth to call out as part of that we have been factoring in our guide. Thank you. Great. Next question, please.

The next question will be from Michael Yee from UBS. Michael, your line is live.

Thanks. Talking about the strong OUS launch, can you talk a little bit about which specific regions are seeing the most growth in and make a comment about India where I know there's a lot of noise about generic launching. I know there's some capacity constraints as Reddy has made some comments. So maybe just talk about what you're seeing specifically there as well, even with generics launching. Thanks.

Okay, great. I assume we're talking about Manjaro. So Patrick, to talk about the OUS launch Manjaro kind of pockets of strength and then any early observations of generic semi-glutide in India or other markets.

Happy to do that. So when you look at the performance of Monjaro US, we actually continue to perform very strongly, more or less everywhere. And we have taken a market leadership position across many different markets. But among the key drivers, I would highlight the China NRDL, where we obtained the category leadership already after 16 months. But beyond that, we see significant growth in Korea, the UK, Mexico, and Germany. and in many markets, we have a market share today very similar to the level of the US or even above. In terms of learnings from the launch of generic semaglutide, if we look specifically at India and even Brazil, we continue to see TRX growth for Monjaro even after the launch of generic semaglutide. and I think that's driven by the strong differentiation we have with the superiority data and I think that's the first line of defense. But we have also been pleasantly surprised with what we see in Canada, where actually the Hirsepatide TRX continue to grow with the same pace as a total market TRX and we have also seen the generic companies actually having significant supply constraints. So I think that's something that we need to monitor very closely. but in an essence, strong performance across the globe, outside of the U.S. and so far, the differentiation of Tirzapatide seems to be a strong line of defense and most importantly, our overall product portfolio will position us very well in the future as well here.

Great. Next question, please. The next question will be from Terrence Flynn from Morgan Stanley. Terrence, your line is live.

Great. Thanks for taking the question. Just on Foundeo, I was wondering if you could... provide any insight on how extensive your sampling program is and if that's having any dampening effect on the IQVIA prescription data that we're all watching every Friday. And what do you see on the U.S. prescribing base here? Are you seeing some expansion and can you quantify that for us? Thank you.

Great. We'll go to Ilya to talk about Foundeo sampling and U.S. prescribers and Terrence's Fridays.

Yeah, so on sampling and in general, like our full promotion, we've got pretty much every lever going on in terms of promotion. Sampling, we're incorporating the sample, the first 30 days of the first dose, pretty much similar to what you would see for a typical oral small molecule in the retail market. So we have extensive sampling across the prescriber base and we continue to have full supply to enable to do that, to get that first experience and understand the benefits and safety of Foundeo. In terms of prescriber base, we've seen a pretty good uptick and continued growth in the number of prescribers. The last time we talked on earnings, we talked about about 8,000 prescribers. prescribers. We've now increased that to 36,000 prescribers. And so we continue to see week on week in continued progress on the adoption awareness and the improved perception of Foundeo profile for people living with overweight and obesity. So we feel pretty good about going forward inflection points with increased access and consumer awareness.

Great. Next question, please.

The next question will be from Umair Rafat from Evercore. Umair, your line is live.

Thanks, guys. I have a question on net pricing and obesity, if I may. So, as you know, Zebb Bounce net price is about $580 per prescription, which is meaningfully higher than the cash pay price, but also higher than Wigovi net price of about $380 per prescription. So, Dave, last quarter you mentioned there's a lot of medical exception that might be driving some of this delta, and my question is, How sustainable is that, especially given CVS is back on formulary? And is this what drives the favorable rebate adjustments quarter after quarter? Thank you.

Thanks, Umar. We'll go to Lucas to talk a bit about net pricing in Majara, or ZEPP Bound, and any of the net exception dynamics.

Yeah, Umar, thank you for the question. Maybe just to anchor this back on the prices on ZEPP Bound. Different to many other molecules, by the way, there is a lot of transparency on all the different channels and you have all the access to see that data starting with Lilly direct on direct to patient prices. Again, you know that is starting point at $299 all the way to $449. Now you have the bridge program at $245 as well. And of course, again, you have then the commercial price, again, that is part of this equation. You mentioned medical exception. That's a driver. I think when you factor on your analysis as well, it's important to highlight again the size of the scripts as well. That is another driver that is affecting the price component, in particular in that commercial segment price. It's impacting, of course, again, the price. You can then try to extrapolate what is the price per pack that is significantly lower than that. In terms of medical exceptions, yes, there are a few buckets. You mentioned one of them. For example, again, the template on CVS access that we are very happy that we accomplished now starting in Q4 will drive, basically, as you know, since last year when, again, CVS moved to 101. there were three options basically for the patients back then was one was to move to the competitor price a product basically the other one was to go to the cash market and the third one was to go through the medical exception process going back to your point we are happy actually and now all along our goal is to have access the medical exception is maybe a short-term thing and our all-along view is to have open access for all the patients so expect that price will actually go down for sure because of this but it's very much embedded in our guide and it's basically reset on again our expectations and of course we are going to more than offset that with volume growth.

Next question please. The next question will be from Jason Gerbery from Bank of America. Jason your line is live.

Hey guys, thanks for taking my question. Mine's just on M&A. You guys surprised investors, I think, getting back into psychiatry and with some vaccine deals. And so I'm wondering if you think these two areas, psych and vaccines, are areas that, you know, Lilly can scale and is this high priority? Or do you see some of the assets as more one-off or you're just intrigued by the science? So just wondering if you can kind of characterize the strategy there. Thanks.

Great, thanks Jason. We'll go to Jake to answer the question more broadly about the M&A strategy and the other work we're doing there.

Yeah, thanks for the question. I think what these two areas have in common is just the immense unmet need that still remains and that really is the through line of all of the work that we do both internally and through business development. So, you know, in this case we saw an opportunity to acquire technology and medicines that we think have the potential to be really impactful and at prices that allow us to remain disciplined and create value long-term for Lilly shareholders. It's not actually that different, frankly, than the many other deals that we've done year-to-date and the internal projects that we continue to pursue. Whether we continue to build more around infectious diseases and psychiatry specifically, to your question, I don't want to forward-look too much on that because we'll be opportunistic based on what we see is available for acquisition and partnering. Very excited about those two areas and the specific things that we purchased there. Thanks.

Great. We'll try to squeeze a couple more in if we could.

The next question will be from Louise Chen from Scotiabank. Louise, your line is live.

Hi. Thanks for taking my question. I wanted to ask you about some of your other pipeline products outside of obesity. I know you've put a lot in there. Any specific assets, you know, one or two that you're really excited about that you think the street should be paying more attention to? Thank you.

Great. Thanks for the question, Louise. We'll go to Dan to talk about other pipeline projects outside of obesity and any couple you want to highlight.

Yeah, thanks for the great question. We have a rich pipeline outside of obesity. Maybe I touch on some highlights by therapeutic area. Maybe starting in cardiovascular health, I mentioned the efforts we're doing in ASCVD with gene editing for PCSK9. We also have an oral and an injectable LPA-lowering drugs. Those are huge opportunities. We just commented on some of the new areas. Jake mentioned psychiatry and vaccines, also huge unmet areas. In neuroscience, beyond the psych expansion, we're excited about sleep-wake disorders with Sintesa. and then diseases like addiction, major depressive disorder, which may be addressable with with incretin science as well. So a lot of growth going on in neuroscience as well. And then they come to oncology. I highlighted some of the exciting readouts. It's probably the richest period of oncology readouts and molecule delivery that we've had at the way ever, probably. I'm excited about a number of those molecules, including the two recent deals that we announced, the Colonia in vivo CAR-T idea for multibyloma. That's a thing that has a huge potential against a large unmet medical need as well as the AJAC novel, AJAC inhibitor. and then finally in immunology, I commented on some of the progression that we're having. It's still early days, I think, in watching what this drug can do, excited to see it grow in the marketplace and then new indications coming and new opportunities to continue to grow there in one of the largest segments of immunology right now. And then behind that, a number of combination ideas coming in IBD as well as and so on. So, across our therapeutic areas, we have the strongest pipeline we've ever had. If you eliminated kind of the incretin stuff, this would be a really strong and large pipeline to be proud of.

Great. Thanks, Dan. Paul, we'll do one last question and then we'll close the call.

Okay. The final question today is coming from Dave Reisinger from Lyric. Dave, your line is live.

Great, thanks very much. So congrats on the phenomenal results. I just wanted to ask about Foundeo XUS. So sales in the quarter in a single country, albeit a wealthy one, the UAE were $31 million, which was close to half of the $67 million that Foundeo generated in the U.S. So although the pricing is probably relatively high in the UAE, The results would seem to suggest explosive potential for Foundeo once it's launched throughout the world. Could you comment on how you see its potential, XUS, for obesity? And then separately, how you see the opportunity for Foundeo to be paid for by XUS governments for diabetes? Do you think it will be better reimbursed? than Terzepatide is simply because you can offer it much cheaper to governments for diabetes than you offer Terzepatide. Any color would be helpful. Thank you.

Great. We'll go to Patrick to talk about Foundeo Obesity Expectations XUS and then any color on thoughts on diabetes launch and reimbursement.

Thank you very much. As I shared earlier, we are encouraged by the start in UAE, but also we need to consider that it's very early days and there is a lot of noise in the data. And as always, when you launch a new medicine, there is an inventory build in the beginning as well, although there is a lot of demand created as well. What we have learned so far is that there is a need for an oral in treating both obesity and type 2 diabetes. and I think we have seen that the majority of the patients are naive to incretin treatments. So I think there is a significant opportunity. The major rollout for us, OUS, will happen in the beginning of 2027 with major launches. Type 2 reimbursement, yes, I think we're probably slightly better positioned with an oral for type 2 reimbursement than the data we have seen so far for Ofolgipron with three head-to-head trials. It's quite an appealing value proposition. Nevertheless, we know that reimbursement OUS always takes time. So the focus at the time of launch will be on chronic weight management and building up on the experiences we have had so far in US and UAE.

Great. Thanks, Patrick. Dave, do you have comments to close?

Yeah. Thank you all for joining us. We always appreciate your participation in our earnings calls and your interest in Eli Lilly. As usual, please follow up with the IR team if you have questions we didn't have a chance to get to today and have a great day. Thanks.

Thank you. Ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1pm today, running through September 8th at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 606589. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 606589. Thank you for your participation. You may now disconnect your line.