Eli Lilly and Company (LLY) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q2 2026 Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to your host, Mike Czapar, Senior Vice President of Investor Relations. Please go ahead.

Good morning. Thank you for joining us for Eli Lilly and Company's Q2 2026 Earnings Call. I'm Mike Czapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, who is Chair and CEO and Lucas Montarce, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific and Product Officer; Adrienne Brown, President of Lilly Immunology; Dr. Karoo, President of Lilly Neuroscience; Dr. Yuffa, President of Lilly USA; and Global Customer capabilities; Jake Van Naarden, President of Lilly Oncology and Head of Business Development; Patrick Jonsson, 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 4. We -- additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It 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 5, 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, our 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 Incretins Group, and Lilly's portfolio of medicines extended its leadership position. The U.S. Fade launch continued to build momentum. -- after educating physicians and securing commercial access across all 3 major PBMs in June, we began broad direct-to-consumer marketing to raise consumer awareness. We completed the U.S. submission of FONA for type 2 diabetes and expect regulatory action later this year. We launched Foundayo 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 Foundayo to treat obesity outside the U.S. Vanda's under regulatory review in over 40 additional countries and we look forward to additional approvals later this year. We're also achieving -- we also achieved several key pipeline and regulatory milestones since our last call, including the U.S. FDA approval of Elis for maintenance dosing once every 8 weeks in atopic dermatitis, the EU approval for J. Perka in CLL across all lines of therapy, a positive CHMP opinion in the EU for insulin [ Fatura ] alpha for type 2 diabetes under the trade name Boswick and positive top line results in 3 Phase III reditrutide 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 Kurbo, LimmaTech Biologics and the vaccine company. building a platform of potential new medicines to prevent infectious disease and their downstream complications. And we acquired a 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. We Lastly, in partnership with the U.S. 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. We 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. We'll 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 billion 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.

Thanks, Dave. As shown on Slide 7, Q2 was another strong quarter of financial performance. Revenue grew 48% compared to Q2 2025, driven by [ Sean and Monaro ] with strong momentum across all 3 areas and geographies. Gross margin as a percentage of revenue was 86.3% in Q2, an increase of approximately 1.3 percentage 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 III programs. Our non-GAAP performance margin was 54.8%, an increase of 9 percentage points from Q 2025 driven by revenue growth. Non-GAAP earnings per share were $8.38, including acquired IPR&D charges of $3.3, this compares to earnings per share of $6.31 in Q2 2025, inclusive of $0.14 of acquired IP R&D charges. On Slide 8, we quantify the effect of price, rate and volume on revenue growth. U.S. revenue increased 33% in Q2, primarily driven by volume growth set by Mounjaro as well as contributions from our immunology, oncology and neuroscience portfolio. U.S. price declined by 3%, driven by Saban and Monaro. In Q2, U.S. price benefited from a change to estimates for EBITs and discounts. Excluding these adjustments, U.S. price declined by 9%. The Europe revenue grew 55% in constant currency, driven by sustained strong volume growth of Mounjaro. Europe revenue also benefited from a $250 million charge and milestone payment. In Japan, revenue grew 30% in constant currency, driven by Mounjaro and Kisunla. In China, revenue grew by 93% in constant currency, driven by the uptick of Monaro. And in the rest of the world, revenue grew 136% in constant currency, driven by Mounjaro, primarily in Latin America and Asia. On Slide 9, we provide an update on the performance of our key products. Within immunology, athletes worldwide sales more than doubled compared to Q2 2025. In the U.S., Apples continued to gain share of new prescriptions increasing by approximately 4 percentage points in the specialty dermatology market since last year. In oncology, Jaypirca 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 Jaypirca has the potential to be a foundational therapy across multiple settings and regimens within CLL. In Lulia continued strong uptake in the metastatic breast cancer oral serve market. after only 2 full quarters in Lurio in the U.S. is a leader in new prescriptions with more than 50% share. We look forward to the readout of #4 in the adjuvant setting to see if [ FINLUrIo ] can help even more people with breast cancer. In neuroscience, Guisonda posted strong revenue growth expanding its leadership position in the U.S. and the amyloid target therapy market. Diagnostic testing momentum also continued to build and the number of P-tau217 blood test more than doubled compared to Q2 2025. This is translating to more people being diagnosed with Alzheimer's disease and accessing treatment. Outside the U.S., solid performance in China and Japan contributed to growth as well. Finally, in cardiometabolic at, Mounjaro and SERD 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 U.S. in creating analog market grew 31% compared to Q2 2025. The early uptick of all 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 3 out of 4 new patient starts. Within the U.S., including analog obesity market, total prescriptions grew by 78% in Q2 and the Lilly anti-obesity portfolio continues to lead. In Q2, approximately 6 out of 10 total prescription and approximately 7 out of 10 injectable prescriptions were for all Lilly medicine. Self-pay continued to be an important segment within obesity and accounted for approximately 45% of total Sepon prescriptions in Q2 and approximately 55% of new prescriptions. In the U.S., Type 2 diabetes incretin analog 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 6 out of 10 prescriptions for an incretin were for all medicine. Outside the U.S., Lilly's portfolio is also performing well in the incretin analog market. Slide 11 shows aggregate trends in the international incretin analog market, which has increased by 74% since the same period last year as measured by IQVIA gross sales. Lilly is the global market leader and we strengthened that position, gaining almost 2 percentage points of share compared to Q1 2026, reaching approximately 55%. Mounjaro Q2 revenue growth was robust, driven by China, Korea, Germany, the U.K. and Mexico. We expect continued strong performance outside the U.S. but with market share leadership already established, market expansion will be key to driving sustainable growth. We also saw incremental progress on securing reimbursement, reimbursed access as Mounjaro is now reimbursed for both type 2 diabetes and obesity in France. Slide 12 provides an update on the Foundayo launch and the cadence of anticipated upcoming catalysts. The U.S. launch is progressing well. Total prescription share of new patients continue to grow as we are increasing our investment to turn 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 our global rollout in all major markets in 2027. We also expect readouts of many additional clinical trials. The first readout in our strategy sleep apnea will come later this year, and we have an additional 5 ongoing Phase III programs staying Foundayo. As a small molecule that can be produced at scale, Foundayo has the potential to have millions of people improve their cardio metabolic cost. 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 million and $87 billion. Based on higher revenue, we now expect our non-GAAP performance margin to be between 49% and 5.5% an increase of 2 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 IP R&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 retatrutide, we announced positive results from 3 Phase III trials. Triumph 1 in people with a visit 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 TrinT2and TRIM 3 trials, -- we now have the clinical data package to support global registrations in obesity, obstructive sleep apnea and knee osteoarthritis pay. Slide 15 shows impressive and consistent weight loss across the Trinuregistrational program. In TIMP1, we saw weight loss approaching bariatric surgery levels at the highest doses and clinically meaningful efficacy at low doses with only 1 titration step. In patients with diabetes and obesity, who typically struggle to lose weight. Reditrutyde delivered a magnitude of weight loss not previously seen with incrogen 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 1, 2027 under the BLA pathway. Turning to Orphaglipron. We have completed our U.S. submission in type 2 diabetes supported by the ACHIEVE Phase III program. In June, we presented detailed results from 3 of those trials, ACHIEVE 2, ACHIEVE 3 and ACHIEVE 5 at the American Diabetes Association Scientific Sessions. ACHIEVE I was the first head-to-head comparison of 2 oral GLP ones. -- and orphaglipron 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 deep reaching their glycemic targets, we believe or for Glipron 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 [ epcotora ] alpha for patients with type 2 diabetes. The opinion was based on the Phase III program were once weekly insulin epatoralpha 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 VERVE 102. Our gene editing program in cardiovascular disease, designed to inactivate the PCSK9 gene resulting in lowered LDL cholesterol. In the Phase Ib study, the single infusion reduced PCSK9 by 88% in 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 fasting cardiovascular benefit. Moving to neuroscience. We announced an agreement to acquire Time Beckley, which is advancing a pipeline of rapid-acting neuropathogens for treatment-resistant depression and other mental health conditions. The lead asset, BPL 003 has shown encouraging Phase IIb results. This remains 1 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 Itai Beckley team to Lilly. With the SYNTEtA acquisition now complete, we added Clemen Orexin to the pipeline in Phase II. Clemenarextan is the potential best-in-class Orexin-receptor 2 agonist being studied in a Phase II/III trial in central hypersomnias. 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 this Cites pipeline we may have the potential to treat a broad range of diseases. Turning to oncology. We recently presented detailed Phase III results from brewing CLL 322 at the 2026 EHA meeting, which added partibrutinib to a time-limited venetoclax and rituximab regimen in previously treated CLL. As shown on Slide 16, in the overall study population, adding partibrutinib 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 1 prior covalent BTK inhibitor, adding partibritinib 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 submitted these data to global regulatory authorities. Also in oncology, we shared impressive new data from the LIBRETTO 432 Phase III trial of selpetatinib 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 selpercatinib 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 test across all stages of disease. We are also excited by the encouraging data presented at medical meetings from 2 recently acquired hematology programs, AG111095, a type 2 JAK inhibitor from Ajax Therapeutics and KLN 1010 in 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 Ajax and Colonial. Moving to immunology. The FDA approved a new maintenance dosing regimen option for lebrikizumab, giving patients with atopic dermatitis and the option to manage their condition with as few as 6 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 lebrikizumab. With our partner, Almirall, we're exploring even less frequent dosing once 12 weeks. These data are expected in 2027. We're also working to bring lebrikizumab to more patients. Based on the positive Phase III results in children 6 months to 18 years old in the adorable trial program, we submitted for a pediatric atopic dermatitis indication in the U.S. 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 2 Phase II trials of benepatide 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 mentality. 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 II trial of our FXR agonist in combination with miratizumab in Crohn's disease and a Phase II trial of our XCL12 antibody in Vitiligo 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 Curbo, adding is in a potential next-generation verazelezostervirus vaccine for the prevention of shingles. In Phase II head-to-head study against the current standard of care, MISO's 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 reach of shingles prevention and reduce long-term risks of dementia and stroke. Next, LIMITX 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 I for 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 is a lead program against Epstein bar virus, an infection with no vaccine today. Beyond acute mononucleosis, epti Bar 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 there is significant unmet 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 movements since our last earnings call and the full list of potential key events expected in 2026. We -- 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 3 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.

[Operator Instructions]. The first question today is coming from Seamus Fernandez from Guggenheim.

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 1 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?

Great. Thanks, Seamus. Maybe 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 then, 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 after more patients in terms of access, you see a meaningful improvement in access with Bridge as well as some state Medicaid access going live or committing to next year. We continue to see significant growth even in Q2 and overall TRx coming in to treatment of obesity on 3 million TRx. And 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 dep 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 consumer awareness and building out the need and urgency to treat obesity, and we continue to look for ways to expand our Lilly direct offering and make it easy for people to get access to care. Patrick?

Thank you. When we look at the obesity business outside 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 the U.S. as well. And we have launched portions of Lilydirect outside of the U.S. However, it's important to take into account that regulations OUS differ and so will the different models that we will apply, but we will move quickly in this space. And I think they have 1 thing in common, and that is to make sure that patients are being reached by state and authentic early medicines, and we'll continue to lean in on those ports.

The next question will be from Asad Heider from Goldman Sachs.

Great. 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 that are there and when do 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 loan trajectory Novo is now also scaling launches for their oral pill in several key ex U.S. countries? Are you such as the U.K. 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 3 weeks of launch?

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

Thanks, Asad. So listen, for Fund, we're making pretty meaningful progress on the fund performance and building out the brand. As we said from the start, we're focusing on 3 key areas. One is making sure we educate physicians on the TUNE profile and building out that experience. The second is really achieving greater access and affordability for Foundayo n and the third is building out the consumer awareness. And we're making progress on all 3 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 Foundayo. And with building out just if you take a look at the last 30 days, we've increased access with CVS, adding found Ao 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 Foundayo 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 inflections. So the -- we're doubling the volume that we had just a month ago. And we're starting to see new starts coming in nearly around 1 out of 4 starting on Foundayo. So we're starting to see an inflection point on day on and with continued access growth and overall kind of HCP adoption, we believe that we'll continue to see growth in Foundayo over the coming quarters.

And when we looked at the first launch, we launched in UAE of Alumni and we actually had a strong start and with early signals showing that orals are expanding the market. And similarly to the U.S., we see that 2 patients are actually naive to treatment with incretin. And patients are rating up steadily. And when we look at the Lilis combined incretins tell steady even if we had a second order 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. So there will be no gating of launches it -- 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 things are being referred to, it's very often sell-in data, and that takes into account all of the dynamics with inventory bill. But on our side, very pleased with the start of the launch of Pondeoutside the U.S.

The next question will be from Courtney Breen from Bernstein.

I did just want to probe on the related 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 reditrutideis 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 lay and anything that kind of will help us understand whether this is going to be unique to retitrutide or whether they are going to be subsequent, but incretins that are going to be able to get classified as a BLA going forward.

Thanks, Courtney. We'll go to Dave to talk about the Reno-type filing pathway.

Yes. Thanks, Courtney. As you mentioned, we've been pursuing this for a little while because we believe retrade 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 court. It's 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, but we do need to gather a little bit more on the CMC 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 resitutide. 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 and subsequent data will read out over the coming years. So very excited about the program and look forward to the submission by Q1 next year.

The next question will be from Chris Schott from JPMorgan.

Great. 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 maybe the ramp curve we've seen initially, what you're seeing in orals versus injectables et cetera, a string a sense of like what your -- how you're feeling this is going so far?

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

Thanks, Chris. 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. We're mostly on -- we're seeing CMS on educating physicians and different stakeholders, pharmacies, on the criteria 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 the Le Direct to fulfill on the bridge process. And in terms of momentum, you can see an inflection point for both of our medicines, Zeon and FDA 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 have approximately 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.

The next question will be from Geoff Meacham from Citibank.

I also wanted to say congrats on the quarter. had 2 related ones on retatrutide. The first 1 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 tirzepatide well beyond diabesity with the higher efficacy of redatrutide, are there additional indications that you can now address that otherwise perhaps you couldn't.

Great. Thanks, Geoff. We'll go to Ken to talk about the development strategy on Rett side and then any comments about commercial strategy as well.

Yes. Thanks for the question, Jeff. First of all, I think people are eagerly awaiting authentic redotrutides to be available in the market, and we fully expect that when we get this to medicine to market, people will go with their feet and embrace the really guaranteed product. In terms of development strategy, while we do have a broad based with tirzepatide of indications with RED 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 amount 75%. I think that's exemplary of the the sorts of opportunities we have ahead with this molecule. We're also advancing it in a study in MASH or MALD, 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 REA, which will read out sometime next year. So overall, a 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 linkway 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.

The next question will be from Mohit Bansal from Wells Fargo.

Congrats on the progress. I'll ask a nonincreasing question for extra credit. So breast cancer would love to understand what -- how you are thinking about the post Fesenio strategy in breast cancer at this point? You have are you also have PIK. So is there an all-oral combo on the table as well?

Great. Thanks, Mohit, and extra credit duly noted. Jake will go do you talk about the breast cancer strategy after Verzenio?

Yes. 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 3 most important targets in breast and for the estrogen receptor CDK4/6 and PI3 kinase alpha. We think we have the best medicines for every single 1 of those targets, and we have plans to combine them all. You know about what we're doing with inlinestrant currently an approved product as ENLIRIO with Ember 4 slated to read out next year, the pediment trial, that is a major moment for that medicine. And we're on the precipice of beginning the Phase III program for terselisib, the Pi3-kinase inhibitor, which will be initially combined with existing endocrine therapies. But over time, we envision absolutely combining with in LaRio. And even in the existing study, we'll be combined with investigators' choice of CDK4/6, a lot 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.