Eli Lilly and Company

Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q2 2025 earnings conference call. At this time, all participants are on a listen-only mode. Later, we will be conducting a question and answer session and instructions will be given at that time. Should you request assistance during the call, please press star then zero and an operator will assist you offline. I would now like to turn the conference over to your host, Mike Zapar, Senior Vice President of Investor Relations. Please go ahead.

Good morning. Thank you for joining us for E9 Lilly and Company's Q2 2025 earnings call. I'm Mike Zapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Lucas Mondarse, Chief Financial Officer, Dr. Dan Skowronski, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, Ilya Yufa, President of Lilly USA and Global Customer Capabilities, Jake Van Arden, President of Lilly Oncology, Patrick Janssen, President of Lilly International and Ken Custer, newly appointed President of Lilly Cardiometabolic Health. We're also joined by Mark Heumann, Susan Hedgeland and Wai Wong of the Investor Relations team. During this call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results may differ materially due to several factors, including those listed on slide four. Additional information concerning factors that could cause actual results to differ materially is contained in our latest form 10K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note our commentary will focus on our non-GAP financial measures. Now, I'll turn the call over to Dave.

Thanks, Mike. Q2 is a strong quarter. We delivered robust revenue growth, shared top-line clinical data from multiple phase three programs and invested in several initiatives that will support our future growth. Today, we shared positive top-line data from the ATTAIN-1 or Forgopron trial in people with obesity. In ATTAIN-1, patients taking the highest dose of Orforgopron lost more than 27 pounds or .4% of their body weight. In addition, the safety and tolerability in ATTAIN-1 was consistent with the injectable GOP-1 class. Orforgopron also met all secondary endpoints in this study, improving key markers of metabolic health, such as blood pressure, cholesterol, and inflammation. This is the second positive phase three trial for Orforgopron we reported this year, and we're encouraged by these results. Our goal from the beginning was to create a medicine that has a clinical profile consistent with approved GOP-1s while offering the convenience of a once daily pill and the production flexibility of small molecule chemistry to meet global demand. We believe this medicine has the potential to make a significant impact on human health, and we will now work with urgency to submit Orforgopron around the world to meet the global challenge of obesity. On slide six, we list key Q2 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 38% compared to Q2 2024, driven by our key products. These include EBLIS, Jeperka, Kisanla, Monjaro, Omvo, Verzenio, and Zephound. In the US, we continue the robust uptake of Zephound and Monjaro, and Lilly gained market share in the Anchortin analog class for the fourth quarter in a row. Monjaro also recently became the market leader in the US in total prescriptions within the Type 2 diabetes Anchortin market. Outside the US, we continue to launch Monjaro in new countries. These include Mexico and Brazil most recently. We have now launched Monjaro in most major markets. Q2 is also a quarter of continued investment for Lilly. In addition to increasing commercial activities to support our newest medicines, we started multiple new clinical programs. While the company is experiencing rapid revenue growth, we're also increasing our R&D investment as early phase program data continues to impress us and to support our future growth of the company. Our financial performance in the first half of 2025 was strong, and as a result, we raised our revenue and earnings for share guidance. Lucas will cover this in more detail during the financial update. In addition to the results from AttainOne, we achieved several key milestones since our last earnings call. These include the US FDA approval of a new dosing schedule for Cassandra, the positive European CHMP opinion for Cassandra, announced positive results in the surpassed CDOT phase three trial for trisepatitis in people with Type 2 diabetes and heart disease. We announced positive results in the Bruin CLL 314 phase three trial of perturbutinib in CLL and SLL. And we launched the two highest doses of Zepbond and Vials in the United States. We announced and closed the acquisition of SiteOne Therapeutics, which expands Lily's pain portfolio and adds a clinical stage non-opioid pain program to our mix. And VIRB Therapeutics, which adds new genetic medicines for cardiovascular disease with potential to only be administered once in a person's lifetime. We made progress in Q2 and throughout the first half of 2025 to bring new manufacturing capacity online. We produced more than 1.6 times the amount of saleable increments doses during the first half of 2025 when compared to the first half of 2024. This includes a significant step up in capacity from our recently constructed facility in Research Triangle Park, North Carolina. We will continue to bring more capacity online in the second half of 2025 and expect our production capabilities to increase further. We also plan to announce the location of two of our new US manufacturing facilities later this quarter. During the quarter, we distributed $1.3 billion in dividends and executed approximately $700 million in share repurchases. Before I turn to the caller, Lucas, I'd like to offer some perspective on the drug pricing reform discussion that's going on. While we support the administration's position that medical research costs need to be shared more equitably across developed countries, it's also true that the US pharmaceutical market has significant defects, which shift costs to consumers and increase red tape. These problems also require urgent reform and make apples to apples comparisons of X-factory pricing inaccurate and misleading. At Lilly, we've already implemented several initiatives which directly lower patient costs for our most commonly used medicines. We operate a direct to consumer model at scale through Lilly Direct, which provides more affordable access to Lilly medicines. This includes our leading weight loss medications that found at a discount of more than 50% off the list price. We also led in resolving insulin pricing issues in our country by reducing list prices by 70% and ensuring broad access to $35 monthly patient costs, including for Medicare. Negotiated prices in Europe come with broad access, low patient co-pays, and without administrative hurdles like prior authorizations. There are also no intermediaries that distort prices and hospitals do not seek profit by selling medicines and marking them up. If we import foreign price controls and insert them into a US system that isn't built to function for patients, we risk embracing the worst of two worlds, the low productivity and output of Europe's biopharma sector with the high out of pocket and distorted prices of the US insurance market. Both today's patients and the future of new cures and treatments will suffer, along with the United States competitiveness. Of course, we will engage and are committed to working instructively with the administration to find solutions that both benefit patients while preserving the hope for tomorrow's cures and the scientific base that has made America the envy of all in global pharmaceutical innovation. Now I'll turn the call over to Lucas to review our Q2 results.

Thanks, Dave. As shown on slide seven, Q2 was another strong quarter of financial performance. Revenue grew 38% compared to Q2 2024 driven by our key products. Gross margin as a percentage of revenue was 85% in Q2, an increase of three percentage points versus the same quarter last year. The increase in gross margin was primarily driven by improved cost of production and favorable product mix, which were partially upset by lower realized prices. Marketing, selling and administrative expenses increased by 30% as we continue to increase investment to support our newest launches across therapeutic areas and geographies. R&D expenses increased 23% driven by higher expenses for late stage assets and additional investment in early stage research. Our non-gap performance margin, which we define as gross margin less R&D, marketing, selling and administrative expenses as a percentage of revenue was 45.9%. Performance margin increased by more than six percentage points from Q2 2024 driven by revenue growth. Our Q2 effective tax rate was .5% consistent with Q2 2024. At the bottom line, earnings per share increased 61% to $6.31, including of a negative impact of 14 cents from acquired IPR&D charges. This compares to $3.92 in Q2 2024, which also include 14 cents of acquired IPR&D charges. On slide A, we quantify the effect of price, rate and volume on revenue growth. US revenue increased 38% in Q2 driven by strong volume growth of Sepan and Monjaro, partially offset by an 8% decline in price. In Europe, revenue grew 77% in constant currency reflecting the strong uptake of Monjaro. Japan revenue grew 7% in constant currency driven by Monjaro and Eclipse. In China, revenue increased 19% in constant currency driven by volume growth of Monjaro. Revenue in the rest of the world decreased by 1% in constant currency, driven primarily by stocking in the base period related to Monjaro launches in new markets. This impact was largely offset by volume growth of Monjaro and Versenio this year. Slide nine provides an uptake of the performance of our key products. Beginning with immunology, Eclipse continues to perform well in atopic dermatitis. New patient starts and revenue trends are strong and total prescriptions have nearly doubled since Q1. We also made progress securing access and Eclipse is now covered by all three of the largest pharmacy benefit managers that represent 90% of people with commercial insurance. Porombo, we are one full quarter into the launching Crohn disease and are making progress in a competitive market. The new site with free formulation is available in most major markets and we are seeing positive trends in new patient starts in the US, Germany, Japan and other international markets. Moving to oncology, physician feedback on Jirperica continue to be very positive. While still only approving later lines of CLL and MCL,

we

have seen a strong update within the label population and encouraging trends regarding time on therapy. We continue to generate additional data in phase three trials that we believe will support an expanded label and use in early settings. We recently announced positive results of Peruvian 314 in CLL and SCLL is another positive step forward those goals. Versenio global sales grew 12% in Q2, driven by volume growth. Versenio continue to be the NBRX and TRX market leader in the US and a standard of care in high risk early breast cancer. US prescriptions grew by 4% in Q2 compared to Q2 2024. An international volume grew by 18%. Within neuroscience, Kisandla is continuing a steady launch trajectory and we are making significant progress in driving healthcare system readiness and adoption. In the US, we are seeing a strong diagnostic growth driven by PET and the acceleration of blood biomechanics tests. This momentum is leading to more people being diagnosed and accessing treatment. Over 1500 physicians and 150 of the top healthcare organization have started patients on Kisandla. Outside the US, efforts are progressing as well with approval in 13 countries. In Europe, we anticipate approval and launch later this year following the recent CHMP positive opinion. Finally, moving to cardiometabolic health, Monjaro and Zepvan both deliver impressive performance. Monjaro posted $5.2 billion of global sales and exited the quarter with more than 50% of new type 2 diabetes increasing prescriptions in the US. Monjaro also became the US market leader in total type 2 diabetes increasing prescriptions in July and has gained 8 percentage points in total prescription share of market during the first seven months of 2025. With the recently announced positive results from SuperCVOT, we look forward to submitting this data to global regulators to support a label cardiovascular indication. Outside the US, Tercepidout is now launched in most major markets. As a reminder, Monjaro is marketed as a single brand for both chronic weight management and type 2 diabetes in all international markets except Canada and Japan. While the initial reception of recent launches in Mexico, Brazil, China and India has been excellent, the commercial activities have been measured to ensure demand doesn't exceed supply and that patient and physicians have a good experience. Zepvan performance was strong in Q2, contributing $3.4 billion of sales. Zepvan continues to be the US market leader in the branded anti-obesity market with two thirds of total patients taking Zepvan. We recently launched the 12.5 and 15 milligram single use vials in Lididaract. All doses of Zepvans are not available in the vial presentation. While we work to secure broader investment of anti-obesity medicines, we are encouraged by the object of Zepvan in vials. The cash pay vials were approximately 20% of total US Zepvan prescriptions and over 35% of new prescriptions in Q2. As a reminder, effective July 1st, the CVS Pharmacy Benefit Manager began excluding Zepvan as an offering for patients on its template formula insurance plans. This has caused significant disruption to patients and we strongly disagree with the decision to restrict access to medicines for patients. As demonstrated in randomized clinical trials, in-cretein medicines for chronic way management are not all the same. While it's still early, we have seen this decision negatively impact Zepvan prescriptions during July and expect it to be a headwind to the rate of volume growth in Q3. We remain confident in the long-term growth outlook for Zepvan as the most widely used in-cretein therapy in the branded anti-obesity market. On slide 10, we provide a view on the US in-cretein analog market, which include prescription for both type 2 diabetes and chronic way management. Q2 was another quarter of steady market growth as total prescription grew by 41% compared to Q2 2024. Lilly performance was again strong with share of market reaching above 57%, an increase of 3.8 percentage points compared to Q1 2025. While market growth continued to be robust, overall penetration into the addressable population is still low and we believe significantly more patients can benefit from in-cretein therapy. On slide 11, we provide an update on capital allocation. Moving to slide 12 is our updated expectation for our 2025 financial performance. We are encouraged by the underlying performance we saw across the business in the first half of the year. We are increasing the bottom and the top end of the revenue range, as well as our expectation for performance margins and earnings per share. We now anticipate our revenue will be between 60 and 62 billion dollars. This range reflect the strong performance and attainment from foreign exchange rates. We will continue to invest to support our newest launches and to develop new medicines. Given our updated expectations for revenue growth, we now expect non-GAAP performance margin to be between 43 and .5% as a percentage of revenue. The potential effect of tariffs remains dynamic and we will continue to update our estimate as the situation changes. We expect the 2025 impact of currently announced tariffs to be modest and this has been factored into our 2025 guidance range. At the bottom line, we have increased our outlook for non-GAAP earnings per share and expect EPS of $21.75 to $23. As Dave mentioned earlier, we exceeded our increasing saleable doses production in the first half of the year and expect to bring more capacity online during the second half of 2025. We expect to produce at least 1.8 times the number of saleable increase in doses in the second half of 2025 compared to the second half of 2024. Now I will turn the call over to Dan to highlight our progress on R&D.

Thanks, Lucas. We've made quite a bit of progress since our last earnings call. During just the past two weeks, we shared three phase three readouts from some of our most important molecules. I'll start with these. Last week, we announced results from the Terzepotide Surpassed CVOT Trial, where Terzepotide demonstrated cardiovascular protection in a landmark -to-head trial, which was the first ever cardiovascular outcomes trial comparing two incretin therapies in people with type 2 diabetes and cardiovascular disease. It included over 13,000 participants across 30 countries and it is the largest and longest study of Terzepotide to date. As shown on slide 13, Terzepotide achieved the primary objective of the study, demonstrating non-inferiority compared to trolicity with an 8% lower rate of MACE3 events. Terzepotide showed consistent results across all three components of the MACE3 composite endpoint. We were particularly impressed to see the rate of all-cause mortality was 16% lower on Terzepotide versus dual-glutide. Because this trial did not include a placebo arm, we conducted a pre-specified indirect comparison analysis of matched patient level data from the Rewind and Surpassed CVOT studies. This analysis showed that Terzepotide reduced the risk of MACE3 by 28% and reduced all-cause mortality by 39% compared to putative placebo. We're very pleased with these results, which show that in addition to the well-established -in-class weight loss and A1C control, Terzepotide now also provides a cardioprotective benefit and may provide more wide-reaching health improvements, including greater kidney protection and a reduced overall risk of death. We look forward to detailed results being presented at the EASD meeting in September and published in a peer review journal. We plan to submit these data to global regulators by the end of this year. The Surpassed CVOT results reinforce our enthusiasm for Sermount MMO, which enrolled over 15,000 participants with obesity and will assess the impact of Terzepotide on reducing morbidity and mortality. This is an event-based study, and the rate of accrual will dictate the timing of the readout. While Surpassed CVOT and Sermount MMO are likely the largest randomized trials we'll conduct with Terzepotide, we'll still explore additional indications for this molecule, and we're excited to have started a new phase three trial in people with type 1 diabetes. Moving on to Orphoglipron. As Dave mentioned, today we're excited to announce top-line results from our second Orphoglipron phase three trial, ATTAIN-1. This trial included people with obesity but without type 2 diabetes. As shown on slide 14, patients in ATTAIN-1 lost on average between .8% and .4% of their body weight after 72 weeks. Depending on the dose. At the highest dose, the average participant on Orphoglipron lost more than 27 pounds, and approximately 40% of people on this dose lost more than 15% of their body weight. We also saw notable improvements on important drivers of cardiovascular risk, including non-HCL cholesterol, triglycerides, and blood pressure. Moving to slide 15, we are very pleased with the safety profile of Orphoglipron in ATTAIN-1. The most commonly reported adverse events were gastrointestinal, which is consistent with the GLP-1 class. Discontinuations due to adverse events were low, with 5 to 10% of patients discontinuing Orphoglipron across doses. There were no hepatic safety signals. We look forward to sharing detailed results from ATTAIN-1 also at the EASD meeting in September, and in a peer-reviewed publication. With today's readout, we've now seen results from two large phase three clinical trials involving over 3,600 participants, and we're highly encouraged with what we've seen thus far. The data from these first two pivotal studies provide evidence that a once-daily oral GLP-1 can achieve efficacy and safety in line with injectable GLP-1s. Orphoglipron has the potential to be a more convenient alternative to injectable treatments, and to be utilized to support early disease intervention in the primary care setting. With these data in hand, we're now working to move quickly towards our first regulatory submissions yet this year. We expect results from four additional Orphoglipron phase three trials over the next five months, three trials in people with diabetes from our Achieve program, and one additional trial from the ATTAIN program in people with diabetes and obesity. ATTAIN-1 and ATTAIN-2 will support global submissions for chronic weight management, which we expect in Q4. In addition to the ongoing phase three trials for Orphoglipron and diabetes, obesity, weight maintenance, and obstructive sleep apnea, we initiated a new program for Orphoglipron this quarter, ATTAIN Hypertension, focused on reducing systolic blood pressure at 36 weeks as the primary endpoint. This is the first study of Orphoglipron that includes patients with a baseline BMI as low as 25. We also announced plans to initiate a new phase three trial in people with knee osteoarthritis pain and overweight or obesity starting later this year. Moving to Pertibrutinib, we announced positive results from the Bruin CLL314 phase three trial of Pertibrutinib compared to Ibrutinib in people with CLL-SLL. This trial included treatment naive patients, as well as patients previously treated, but not with a BTK inhibitor. Pertibrutinib met the primary endpoint of response rate non-inferiority compared to Ibrutinib and had a nominal P value for superiority that was less than 0.05. While progression-free survival data were immature, there was a positive trend in favor of Pertibrutinib. Additional testing for progression-free survival is planned as part of a future analysis. Of note, the subpopulation of treatment naive patients had a particularly pronounced progression-free survival trend in favor of Pertibrutinib. This subpopulation had the longest follow-up, which is encouraging for what we might see more broadly across the total study population over time. This is the second positive phase three trial to read out for Pertibrutinib as we continue to build evidence supporting the potential role for this medicine in earlier settings. We look forward to the readout of Bruin CLL313, which assesses Pertibrutinib versus chemoimmunotherapy in treatment naive CLL-SLL later this year. We expect these data in combination with Bruin CLL314 to form the basis of regulatory submissions globally. In addition to our recent phase three readouts, we also have updates on several other important molecules, Denenemab, Rhetatrucide, and Olomiracip. For Denenemab, we had three important milestones since our last earnings call. First, we were pleased to receive a positive opinion from the CHMP in the EU. We look forward to approval and launch there later this year. Second, the modified dosing schedule was approved in the US, further strengthening the safety profile for Denenemab, and we expect the modified dosing regimen to be part of the EU labeling at launch as well. Finally, we shared long-term extension data from Trailblazer-ALS2, which demonstrated that over three years, Denenemab treated participants showed increasing clinical benefit, despite most participants having completed treatment within the first 18 months of the trial. In a separate part of the extension study, patients initiating Denenemab after 18 months of placebo also demonstrated disease slowing once they started Denenemab. These data reinforce the value of early intervention and support the limited duration dosing approach with sustained and increasing long-term benefits for treatment. For Rettitrutide, we started a new phase three trial in chronic low back pain and overweight or obesity called Triumph 7. This is our second pain study for Rettitrutide in addition to the ongoing study in osteoarthritis pain of the knee, Triumph 4, from which we expect results later this year. We are excited to announce plans to initiate a phase three study in high risk metabolic dysfunction associated steatotic liver disease or Masal D later this year. This trial includes both Rettitrutide and Tersepidide, and it will utilize noninvasive tests to enroll patients who are at high risk of major adverse liver outcomes, with a primary objective of reducing the occurrence of such outcomes. This novel trial design more closely mirrors how physicians diagnose this disease in clinical practice and will enable simultaneous development of both medicines, each compared to placebo. In a prior phase two trial in Masal D, Rettitrutide reduced liver fat by over 80%. And in a phase two trial in MASH, Tersepidide led to over half of patients meeting criteria for resolution of MASH without worsening of fibrosis. We believe each of these medicines has the potential to make a profound impact on this disease, and we look forward to initiating the study later this year. Moving to Olamuracid, we started a phase three trial in unresected adjuvant lung cancer. This marks the fourth indication we are simultaneously pursuing for Olamuracid in KRAS-G12C mutant lung cancer as part of the Sunray 1 and Sunray 2 programs. We believe Olamuracid, in combination with immuno-oncology agents in an early setting, could improve the standard of care for patients with KRAS-G12C mutant lung cancer. I'm also excited that through business development, we've added new molecules to our portfolio and new colleagues to our team. And it's a pleasure to welcome new team members from SiteOne and Verve to Lilly this quarter. With SiteOne, we added a new pain asset into our neuroscience portfolio. STC-004 is a NAV 1.8 inhibitor that's shown encouraging early data to treat pain. We believe this molecule could be an important non-opioid therapy for pain in the future. Through the acquisition of Verve therapeutics, we added several genetic medicines for cardiovascular disease that may only need to be given once in a lifetime. The most advanced programs are Verve 102, which targets PCSK9, and Verve 201, which targets ANGPTL3. And in our early phase portfolio, we advanced Nisoterecide, our PYY analog agonist, into a phase two trial in people with diabetes. And we initiated phase one clinical trials for glucose sensing insulin, a PTK7 antibody drug conjugate in oncology, and a next generation triple agonist in cardiometabolic health. We also discontinued two phase two programs, KB1.3 antagonists for psoriasis, and mezizotide for pain. And two phase one programs, cidiconic mimetic and immunology, and -S-IRNA in MASH. It was a productive period since our last earnings call, and we still have an ambitious R&D agenda for the last five months of 2025. I'll now turn the call back to Dave for some closing remarks.

Thanks, Dan. We're really pleased with all the progress in Q2 across our strategic agenda. We've had another quarter of strong financial results. We continued the build out of our manufacturing footprint and advanced our pipeline, as Dan just highlighted, with external and internal R&D projects. We have good momentum as we enter the second half of 2025, and we're focused on execution with our currently market products, and we're investing in the next wave of medicines that we expect will drive growth in the near and more distant future. So now let me turn the call over to Mike to moderate a Q&A session.

Thanks, Dave. We would like to take questions from as many callers as possible. So consistent with prior quarters, we will respond to one question per caller, and we'll end the call promptly at 930. Please provide the instructions for the Q&A session, and then we are ready for the first caller.

Certainly, at this time, we will be conducting a question and answer session. If you have any questions, please press star one on your phone at this time. We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star one at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we pull for questions. And the first question today is coming from Chris Schott from JPMorgan. Chris, your line is live.

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

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

Yeah, thanks Chris for the question about Orphoglipron. We're really pleased with the data we've disclosed this morning. Really the idea that you can get 27 pounds of weight loss from a single pill and also get really encouraging effects on other important biomarkers, things like blood pressure, lipids, inflammatory biomarkers, and fasting glucose. Those are a lot of the things that HTPs are really managing when they think about preventative care. Now you're getting that all from a single oral pill, but we can manufacture it scale. We also know that simplicity matters in this space and the instructions for use here are gonna be pretty simple. Take it once a day without regard to food and water. Of course, the data we're sharing today are in patients with overweight and obesity, but we are evaluating Orphoglipron in a lot of other settings. That includes other disease areas like diabetes and obstructive sleep apnea and OA need pain. But we're also evaluating in other contexts for treatment of obesity. Right now we have the attain and maintain study ongoing, which is also testing Orphoglipron as a physical maintenance therapy for patients who have lost weight on drugs like ZeppBound to see whether they can keep that weight off. So we really see a wide ranging opportunity for Orphoglipron and couldn't be more pleased with the totality of the profile we disclosed this morning.

Excellent, thanks Chris. Next question please.

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

Oh great, thanks so much for the question. Mine's actually on pricing and the pricing environment going forward. Just hoping, Dave, you could discuss a little bit more your views on the path for price with Orphoglipron and the growing number of assets coming to market. I think that's been probably the number one overhang, especially as it relates to the continued availability of compounding. So just trying to get a better understanding of where you see price going and maybe if you can provide some thoughts on compounding in that context and how you maintain terzepatide compounding off market when it's being ignored with semaglutide. Thanks so much.

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

Okay, yeah thanks Seamus. As it relates to compounding, let me just deal with that first. We've always been concerned about this because of the patient safety risk that exists and every day we get calls from patients concerned that they are getting ill on a medicine they think is ours and it's not. This of course was allowed during drug shortage. There's no drug shortage and we really think that regulators and law enforcement officers in the US need to step up their game to really eliminate this. That's why we have an FDA and a structured regulatory process in the US. And so we wanna see that end mostly because people are being harmed. We see robust growth in the marketplace in the US, 42% total inkerton growth over last year, good sequential growth and of course Lilly's growth is more than double that. The business is fine but people shouldn't be harmed. That said, I think on pricing we've always had a philosophy across all medicines including with inkertons to price to value. And given the profile we present to consider offsetting other healthcare costs including medicines, the value to the patient, the value in the economy as well. And here with GLP-1 and inkerton mechanisms we're seeing profound value frankly. So we're noticing a difference when we offer consumer lever pricing outside of insurance but inside of the healthcare system which is most of the business we think that we'll expect single digit erosion like we do other chronic medications in net pricing while maintaining a value point on list that makes good sense. That's not considering any new policy environment but that's our philosophy going forward. So as we have a suite of products with some with perhaps more value in patients with more complicated obesity or those that maybe have less complicated obesity but medicines like ophorclopron that could reach the masses of course we'll consider those factors in price setting at the list level and then the net will find its level in negotiations. And you can continue to expect Lilly to offer consumer level pricing as long as we have such a large hole in coverage in our country for important chronic disease like obesity that should be covered. Those are our views on pricing.

Thank you Dave, next question please.

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

Great morning guys, thanks for the question. Dan on ophorclopron, you know looking at discontinuation rates it looks competitive for attain and achieve but can you talk about how the GI adverse event rates change over the course of the studies? And were there common futures among those with the highest adverse event rates? Obviously thinking how this could play out from a commercial context, thank you.

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

Yeah thanks Jeff, no surprises in there. The GI profile was as expected for a GLP-1 agonist which is to say that most of the side effects occur early in the disease, early in the treatment course or with those escalations and then they go down over time. In terms of any specific patient characteristics that predicted, I don't believe we saw that in the study nor have we seen that in prior studies with the GLP-1 so. But really no differences here that we thought were noteworthy versus monotherapy GLP-1 injectables.

Great, thank you Dan, next question please.

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

Thank you, I wanted to ask kind of a compounding question in a way I guess, Canadian generics for Novo's samagmatide they're likely to launch in early 26. I think everyone can agree that terzepotide is a better product but won't this still cause a lot of trouble in the market where there's a big cash pay channel and where we already know that patients have proven themselves to be price sensitive and willing to use a lesser product like a knockoff samagmatide seems to me Canadian generics are just a replacement for that compounding channel and they'll keep that headwind alive even if compounders get shut down and we're talking about a product that will have gone through a regulatory review cycle not by FDA but by another regulator. So with that launch six months away, is that a headwind that we should expect may continue? Thanks.

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

Yeah, thanks for the question. Maybe I'll touch on what we're currently seeing in the US market and if you assume looking at the self-paying market that what we're seeing in vial performance and overall market is continuing to grow at rapid pace. We're seeing that our offering with the vial with set down and the profile that we have with set down is meeting a need for patients even in the market in the context of noise whether you have compounded or semi-inverted. You take a look at just the growth that we've seen in Q2. We've generated over 1 million TRX in vial in Q2 and we recently launched last week the highest doses of vial available for set down and we're continuing to see health in that market. Roughly 20% of all of our TRX is coming from the cash pay market and we continue to see strength overall both in self-pay and in covered. We're seeing around 65% share market in new therapy starts for set down overall. So we see health in the market and where set down provides a greater value.

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

The next question will be from Dave Reisinger from Learing Partners. Dave, your line is live.

Yes, thanks very much. So I was hoping to better understand the evolution of US employer coverage for anti-obesity medicines and the prospects. So my understanding is that coverage has been pretty flat on a net basis over the last 18 months let's say since January of 24 meaning the net covered lives has been flattish. If you can confirm that that's correct and then can you talk about the outlook for the net change in US employer coverage for anti-obesity medicines over the next six months or so for January of 26? Thanks very much.

Great, thanks Dave for the question. We'll go to Ilya to talk about the progress in the set down employer coverage often.

Sure, thanks for the question Dave. As we take a look at employer coverage it's important for us to grow coverage over time. What we've seen in different offerings across the different plans, some are more complex than others and we've seen an increase overall but it has been steady around 50 to 55% employer opt-in coverage at the same time. We are seeing new benefit designs like for instance Evernorse, a cap on out of pocket for employees that make the prior authorization or simplify and that may grow employer opt-ins over time that's something that we're working through. Our outlook is that as evidence grows and we find new ways and also different plan designs are available to different employers that that will continue to.

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

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

Great, thanks for taking the questions. Congrats on all the progress. Just wondering on Orphaglipron in light of the attain one data if you can just frame expectations for us Dan for the upcoming attain two phase three data and then any early insights into the potential CMMI, obesity, Medicare, Medicaid pilot that I think we saw some press reports about. Thank you.

Okay, for that we'll go to Ken to answer the question on expectations for attain two.

Yeah,

thanks

Terrence for the question on attain two. We're very pleased with what we disclosed this morning in attain one which is our first phase three study in obesity without diabetes and of course we had a great result with achieve one in patients with diabetes. So as we look ahead to attain two we expect similarly encouraging results. The exciting thing about attain two is that'll be our third phase three study and it sets us up to submit to in obesity by the end of this year. So really no change in expectations here. The team's full speed ahead preparing for submission by year end and a potential approval next year.

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

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

Courtney. Thanks so much for taking the question today. Just coming back to another question on all four. As we looked at kind of comparing the data between attain one and achieve one, we do see that kind of nausea, vomiting, constipation all appear a bit higher in this achieve one study. Can you talk a little bit about the differences in those data points that we're seeing between those two studies and what that might mean for adherence in the real world? Thank you.

Hey Courtney, thanks for the question on comparing achieve versus attain. I think Dan maybe a couple quick comments.

Yeah sure, thanks Courtney. I think the side effect profile in both of these trials was consistent with past experience for GLP-1 monotherapy in these populations which are different as you're pointing out that side effect profiles can be different in people with type two diabetes versus people without type two diabetes and with obesity. So I think we feel quite confident overall about the profile here. Of course, I think I just emphasize once again this is a GLP-1 monotherapy. We know that dual agonism with GLP-1 and GIP-1 can offer superior results. We have that as an injectable as terzepatite. But I think actually this is as good as it gets for GLP-1 monotherapy here in once a day small molecule are also pretty excited with the profile.

Great, thanks Dan. Next question please.

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

Great, thank you very much for taking my question. Dan, if you could comment on the gender split in the Alpha-Glipron study, if there was any difference versus any other trials for GLP-1 that you would want to highlight here. Thank you. Sure,

thanks Mohit. For the detailed question, we'll go to Ken to talk about the gender split. Is there anything to flag? Thanks Mohit.

Gender split for baseline population in attain one was about 64% across the board, well balanced across, 64% female across arms, balance nothing really to remark on here. Great, thanks. Next Ken, next question 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 quarter. Just going back to channel dynamics, on the Lilly Direct channel, clearly ZEPBound growth has been getting a lot of momentum with the new to brand prescriptions. Where do you think this could stabilize and how is that segment changing the landscape on pricing and then related, I think Lucas, you've previously framed this DTC offering for ZEPBound as a hedge or a bridge solution as you continue to grow access in the reimbursed channel. So any evolution in your thinking on that front, given DTC offerings are now getting framed as one way to satisfy the administration's demands on drug pricing, thank you.

Okay, thanks for the question Asad. Lucas, you wanna give some commentary on the Lilly Direct sort of evolution and outlook from here?

Yeah, sure.

Thank you Asad for

your question. First of all, I just wanted to invite the great products that we see in Lilly Direct. I think Elia alluded about total TRS prescriptions that we see in the second quarter, 1.1 million DRX. Fantastic growth and now we are adding the 12.5 and 15 milligrams launch as well. So great progress that we are seeing and you see that data as well that you have access Asad in terms of the number of total DRX as a percentage of the total ZEPBound business. So progressing very nicely, very pleased with that. You mentioned about again, the hedge. Yes, I shared that with you a time ago and that's the way that we think about it. Going back to the previous questions about employer, as we see that progressing, we always thought that it would be a gradual progression on the employer access. We see the Lilly Direct as an option to bridge that, right as a hedge strategy to bridge that. So we still see it the same way, but it's progressing very nicely and it's actually contributing to our performance this quarter and for the rest of the year as well. So that's more of the commentary and the color that we can provide today on that.

Thank

you Lucas.

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

Morning guys. I'm just still trying to get my head around the Orphoglyphron data. On the one side, I see your efficacy estimate at 11 and a half percent placebo adjusted being very consistent with what Novo showed with their oral sema data in OASIS-4. But on the more important ITT-like treatment estimate, Orpho's tracking at 9% placebo adjusted. Oral sema is almost 14% placebo adjusted. And I'm just trying to understand what explains that delta and does it prompt the need for a 45 milligram cohort considering how the safety is tracking?

Thanks Umair. We'll go to Dan to provide maybe some final commentary on that same.

Yeah, thanks Umair. I'm not sure I track exactly with your numbers. But look, I think overall the profile here landed or pretty much where you could expect a GLP-1 monotherapy to land. It's tough to compare different trials done at different time periods, different populations. But I think overall, given the patients we enrolled and the trial we ran, this is what GLP-1 agonism can give you. I don't see this as any issue at all in the real world or for patients or doctors. I know Wall Street has kind of focused on the exact numbers here and making cross trial comparisons. But I don't think that carries over to the real world at all.

Great, thank you Dan. Next question please.

Next question will be from Steve Scala from TD Town. Steve, you're on the black. Oh, thank you.

Thank you so much. With what is widely viewed as disappointing or for glipron data, it seems injectables are where it's at for the foreseeable future. On the Q1 call, Lily said the likely impact of the NOVO deal with CVS would be modest. But today you are saying there could be an impact in Q3. And for Lily to call it out in the prepared remarks, it must be pretty meaningful. So can you tell us what changed in the marketplace for the injectables? Thank you.

Great Steve, thanks for the question. Maybe to give some commentary on CVS, we'll go to Ilya.

Sure, thanks Steve for the question. You know, as we take a look at Q2 performance and the health of both the market and where Zephound has gained share and we added around 1.7 million TRX in Q2, the overall impact, I think what we discussed prior is a couple hundred thousand TRX volume that may vary, it's still early in the transition to CVS and obviously that creates frustration for employers, for providers, for patients. And we don't agree and disappoint with CVS decision. At the same time, in terms of impact, you'll have some medical exceptions and overall in the context of growing 1.7 million TRX, we view and you look at July TRX as a proxy where on average it's back to around May average TRX, we see continued growth and very good performance across all segments for Zephound, both in covered as well as our cash pay market. And so we expect continued growth. I think the commentary is more about the rate of growth. So obviously some new patient starts related to CVS template only may have some impact on growth, but overall the growth is healthy across all other segments.

Great, thank you, Ilya. Next question, please.

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

Another one on Orphaglip are on. So I noticed you included the total discontinuation rates in the PR when you normally don't. Does that suggest that you think there was an underlying driver of these unusually elevated drop rates across all arms and could they have impacted efficacy?

Thanks, Alex. We'll go to Ken to talk about the inclusion of the overall discontinuation rates and how that may have been in some other press releases as well.

Yeah, thanks Alex for the question on discontinuation rates. What we disclosed, of course, with the rate of discontinuation and attain one for placebo of .9% and then for Orphaglip are on ranging from 22 to 24%. We don't think there's anything remarkable there and we've disclosed these information on previous disability programs. I think on SRMAT-1 we did. Maybe to put this in a little bit of context, if you look at analogous studies in obesity, really placebo rates are in the 20s. If you take maybe step one, 22% placebo rate for discontinuation and about five points lower for active comparator, that's exactly what we see here on a delta, so really nothing remarkable here. The more important thing to look at, of course, patients can discontinue a study for a whole host of reasons. They can just withdraw their consent because it doesn't fit with their life. Maybe they're not getting the efficacy they need and that's why we typically see lower rates in the active drugs, which is what we see here, or an adverse event. Now the rates for adverse events, as Dan noted, range between five and 10% for Orphaglip are on. That's exactly where we'd expect to be for an oral GLP-1 single agonist, so really nothing remarkable here. Great, thank you Ken. We'll

go to the next question please.

The next question will be from Akash Tawari from Jeffreys. Akash, you're line is live.

Hey, thanks so much. What's Lilly's appetite to commuting to launching new products at net parity pricing between the US and Europe, given a significant amount of your newly launched products in Europe are actually not getting reimbursed anyway? And more broadly, it sounds like we're in an impasse between the administration and the industry. What's your confidence we'd be able to get kind of a bespoke solution with the administration absent new legislation? Thank you.

Great, thank you Akash. We'll go to Dave to talk on the engagement with the administration and kind of new product launch strategy.

Sure, yeah. I mean, just on the discrete question you're asking, I think we believe long-term we should rebalance pricing between US and Europe in terms of who's bearing the cost for really the amortized R&D and the risk we took. That's a rational thing. In my career, it's gotten more and more out of whack. So I think here the president's right to call that out. The question is really how? And as you know, the European governments don't exactly, they're not signing up to pay more for drugs. So we need trade tools to rebalance that equation. We've been very clear on that advocacy with both European and US governments. And in the US, we need to deflate the gross to net bubble because there's this huge artificial thing that needs to get deflated. The problem with doing that suddenly is all those cash flows into hospitals and premium support for seniors in Part D, et cetera, you can't collapse it all at once. It'd be very difficult, I think. So the idea of new products gives it sort of a ramp, but we need these other structural changes on the US side and the gross to net environment in Europe in terms of the total reimbursement setup to get there. But we'd be excited to enter that world. Actually, I'll point out in a few cases, we are narrowing the gap substantially on new products. And some of that's for the reason you point out that some countries that reimbursement is just a tough equation. So what's the point of lowering that? So watch that space. I think this is an area there could be progress under the president's agenda. And I think you'd see most pharma companies interested in moving in that direction. The question is how do you step into it?

Great, thank you, Dave. We've got time for probably two more quick questions. The next question, please.

The next question will be from Kerry Halford from Barenburg. Kerry, your line is live.

Thank you. Question from me, please, on the cash channel. So yesterday, Novo stated it would make OZembik available via its cash page later this year. Are you planning to do the same for Mount Jaro? And if not, why not? And I'm not sure if you mentioned this earlier, but can you confirm whether you intend to use the cash channel for all for Glipron once that comes to market?

Great, thanks Kerry for the question. We'll go to Iliya to comment on our thoughts on the cash channel.

Sure. Well, first, I think we're learning a lot in the cash channel, where we direct, and a lot of that has to do with the consumer journey, and it's varied across different segments where you have significant coverage versus not. With Mount Jaro, we have significant coverage, so over 90% coverage in both commercial as well as Part D. So I'm not sure if that necessarily provides an additional avenue. With that bound, we see significant growth, because we do have coverage gaps in commercial, and obviously we also have coverage gaps without having the ability to cover anti-obesity medications in Part D. So we see this as an opportunity for us to meet that need. Of course, we'll evaluate other brands that we put through LillieDirect. We have a number of avenues to come to LillieDirect on different brands to make sure that people can access the healthcare system in a better way. And so that's something that will evolve over time.

Great, thanks Iliya. And last question, please.

And final question today will be from Evan Seigerman from BMO Capital Markets. Evan, you're live.

Hi guys, thank you so much for taking my question. A follow up on the MSN conversation. I appreciate you're not gonna share the details of your interaction with the administration, but can you provide some practical examples of what you and the industry can do to help achieve the goals of getting price parity globally? Thanks so much.

Thanks, Evan. We'll go to Dave to answer the question and then to provide closing remarks.

Yeah, sure, I don't have a lot to add to what I said to the prior question. I think long term it makes sense to rebalance this. And having an on-ramp makes sense to me because a sudden change in either environment would be difficult to sustain or justify. So the idea of new products is a reasonable proposition provided that the reimbursement rates in Europe can rise really based on cost for quality analysis and other things and the US gross to net situation can change. And easing into it seems to be a rational thing to do. The other piece which the DTC channel being suggested by the administration and for the prior question, in addition to offering an outlet for people who don't have coverage, it does provide a kind of real price transparency to consumers, employers and others and that's a good thing. So we support that as well. We'll have to see how this plays out. As I said, we're constructively engaging. Hopefully some progress can be made and I think it's in the industry's long term interest to kind of pull these things closer together and we'll work hard to try to do that. Thanks for being with us today everyone and for as many questions as we got to. I know there's always some we did not. So as in prior quarters, if you have unresolved questions, please contact our IR team and we appreciate your interest in the company as always and look forward to future interactions. Have a great day.

Thank you and ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1 p.m. today, running through September 11th at midnight. You may access the replay system at any time by dialing -332-6854 and entering the access code 639-732. International callers can call -528-0005. Again, those numbers are -332-6854 and -528-0005 with the access code 639-732. Thank you for your participation. You may now disconnect your lines.