Ladies and gentlemen, thank you for joining us, and welcome to the Lilly Q1 2025 Earnings Conference Call. All participants are currently in a listen-only mode. We will have a question-and-answer session later, and instructions for that will be provided. I would now like to turn the call over to your host, Mike Czapar, Senior Vice President of Investor Relations. Please proceed.

Good morning. Thank you for joining us for Eli Lilly & Company's Q1 2025 earnings call. I'm Mike Czapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Chair and CEO; Lucas Montarce, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology; Anne White, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly International; Jake Van Naarden, President of Lilly Oncology; and Patrik Jonsson, President of Cardiometabolic Health and Lilly USA. We're also joined by Marc Kemen, Wes Taul, and Wai Wong of the Investor Relations team. During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to several factors, including those listed on Slide 4. 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 and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note that our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave.

Thank you, Mike. Q1 was another exciting quarter. We increased our revenue, advanced our pipeline, invested to drive future growth, and shared the first Phase 3 clinical data from our oral GLP-1 orforglipron. Dan will share more details during the R&D update, but we're pleased with the results from the GLP-1 trial for orforglipron in patients with Type 2 diabetes. These data met our expectations and are the first step to delivering our overall goal for the program, which is to create a medicine that offers injectable GLP-1 like efficacy, safety, and tolerability with the convenience of a once-daily pill that can be manufactured at scale to meet global demand. This scientific breakthrough has the potential to eventually impact hundreds of millions of people around the world with chronic diseases. And we expect Phase 3 data from seven global clinical trials to read out over the next 12 months across Type 2 diabetes and obesity. We also expect potential regulatory submissions for obesity to begin worldwide by the end of 2025. On Slide 6, we list Q1 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 45% compared to Q1 of 2024. Our key products, defined as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound, grew by more than $4 billion and now account for $7.5 billion of revenue for the company. In addition to the orforglipron readout, we achieved several other key pipeline milestones this quarter. They include the approval of Jaypirca in the EU for CLL, the approval of Omvoh in the U.S., EU, and Japan for Crohn's disease, and the initiation of a Phase three program for Olomorasib in resected adjuvant non-small cell lung cancer. We also shared plans to more than double our manufacturing investment in the U.S. In total, we've announced over $50 billion of new U.S. manufacturing investments since 2020, including our most recent announcement to build four new facilities, of which three will be API or active pharmaceutical ingredient facilities. Lastly, we distributed $1.3 billion to dividends in the first quarter and executed a $1.2 billion share repurchase. We realize there's a lot of investor focus right now on tariffs and trade, so I'll make a few comments that reflect our current views on these complex and quite dynamic matters. We support the U.S. Government's goals to increase domestic investment. However, we don't believe tariffs are the right mechanism. Enhanced tax incentives and/or the extension of the Tax Cut and Jobs Act are better tools to achieve their goals. The announced tariffs currently in effect do not materially change Lilly's 2025 financial outlook. However, the expansion of tariffs in other geographies or increases in retaliatory tariffs would have a negative effect on Lilly and for our industry. As a company, Lilly has a large U.S. manufacturing footprint with 10 active projects ongoing to build and expand new sites. Upon completion of our manufacturing agenda, we'll be able to supply medicines for the U.S. market entirely from U.S. facilities, as well as increase the volume of medicines we export. We will continue to execute our U.S. manufacturing agenda. However, we urge the administration to negotiate deals with key trading partners as soon as possible that level the playing field for American exporters like Lilly and remove harmful tariffs and non-tariff market access barriers in the developed economies. Now, I'll turn the call over to Lucas to review our Q1 financial results.

Thanks, Dave. As shown on Slide 7, Q1 was another strong quarter of financial performance with revenue growing 45% compared to Q1 2024, driven by our key products. Gross margin as a percentage of revenue was 83.5% in Q1, an increase of 1 percentage point versus the same quarter last year. Gross margin was positively impacted by improved production costs and favorable product mix, which were partially offset by lower realized prices. Marketing, selling, and administrative expenses increased 26% as we invested in promotional activities to support new launches across our therapeutic areas. R&D expenses increased 8%, driven by higher development expenses for late-stage assets and additional investments in early-stage research. In Q1, we recognized acquired IP R&D charges of $1.57 billion primarily related to the previously announced acquisition of Scorpion Therapeutics PI3Kα inhibitor program. In total, IP R&D charges negatively impacted earnings per share by $1.72. Our non-GAAP performance margin, which we define as gross margin less R&D, marketing, selling, and administrative expenses, as a percentage of revenue was 42.6%, an increase of over 11 percentage points from Q1 2024. Our Q1 effective tax rate was 20.2%. The Q1 tax rate was negatively impacted by the previously described non-deductible acquired IPR&D charges. At the bottom line, we delivered earnings per share of $3.34 in Q1, inclusive of the negative impact of $1.72 from acquired IPR&D charges. This compares to earnings per share of $2.58 in Q1 2021, inclusive of $0.10 of prior IPR&D charges. On Slide 8, we quantify the effect of price rate and volume on revenue growth. U.S. revenue increased 49% in Q1, driven by strong volume growth of our key products, including Zepbound and Mounjaro, partially offset by a 7% decline in price. Moving to Europe, revenue increased 71% in constant currency. Q1 2025 was positively impacted by a one-time benefit of $370 million related to further restructuring our alliance with Boehringer Ingelheim. Excluding this benefit, constant currency revenue grew 46%, driven primarily by Mounjaro, partially offset by a 7% decline in price. Japan revenue grew 15% in constant currency with volume growing 16%, driven by Mounjaro and Jardiance. Moving to China, Q1 revenue increased 21% in constant currency. Volume growth was primarily driven by Mounjaro. As a reminder, we recently initiated a limited Mounjaro launch in China with the expectation to gradually increase commercial launch in the second half of 2025 as supply becomes available. Revenue in the rest of the world increased 17% in constant currency, primarily driven by volume growth from Mounjaro and, to a lesser extent, Verzenio. Slide 9 provides an update on the performance of our key products. Beginning with immunology, we have seen encouraging U.S. uptake of Ebglyss in atopic dermatitis. New patient starts are increasing, and we are making good progress securing access and reimbursement. Ebglyss is currently covered by two of the largest pharmacy benefit managers, and we expect further access improvement later this year. As of May 1, Ebglyss will be reimbursed on plans that account for 60% of people who are commercially insured. For Omvoh, we have received approval of Crohn's disease across the globe as a second indication. Commercial activities are going to drive new patient starts in this larger patient population. Moving to oncology, Jaypirca was recently approved in Europe for relapsed or refractory CLL in patients who previously treated with a BTK inhibitor. We anticipate launches beginning in Q2. We also expect readouts from additional global Phase 3 trials later this year, which we believe will be important to evaluate Jaypirca in earlier settings of CLL, including a head-to-head comparison with ibrutinib. Verzenio global sales grew 10% in Q1, as Verzenio continues to be the standard of care in high-risk early breast cancer. As expected, we have seen some impact from competition in early breast cancer. However, Verzenio share of market in high-risk early breast cancer is stable and total prescriptions continue to grow. U.S. prescriptions grew by 7% in Q1, partially offset by the wholesaler inventory destocking in the quarter. International volumes for Verzenio grew 30% in Q1. Within neuroscience, Kisunla is now approved in 12 countries. We have seen a steady increase in the use of blood-based biomarkers, the conversion rates from diagnosis to treatment, and the number of new patients starting treatment in both the U.S. and Japan. While it is encouraging to see progress, we do still expect that it will take some time to build this market. We expect U.S. regulatory action for the modified dose enrichment for Kisunla in the next few months. Finally, moving to Cardiometabolic Health, both Mounjaro and Zepbound posted strong revenue growth. Mounjaro sales were $3.8 billion, more than double the same quarter last year. In the U.S., Mounjaro exited Q1 as the market leader in new prescriptions within diabetes incretin analogs. Outside the U.S., Mounjaro has launched in over 40 countries, and Q1 was another quarter of steady sequential growth. We recently launched in India and Mexico and plan to continue with additional countries throughout 2025. Our focus internationally is on seeking reimbursement for Type 2 diabetes and developing the ecosystem to treat obesity as a chronic disease. Zepbound's performance was also robust, as sales increased by $1.8 billion to $2.3 billion in the quarter. Zepbound is the U.S. branded anti-obesity market leader in both total prescriptions and new prescriptions, reaching 60% and 74%, respectively, at the end of Q1. We also launched higher dose Zepbound vials, adding two additional doses for patients to access Zepbound through the self-pay channel. The uptake of Zepbound vials has been strong, and vials accounted for approximately 10% of total prescriptions and 25% of new prescriptions in Q1. On Slide 10 is an update on trends in the U.S. incretin analog market, which includes incretin prescriptions in both Type 2 diabetes and obesity. Q1 was another quarter of steady market growth as total prescriptions grew by 46% compared to Q1 2024. Leading performance was strong as a four-week rolling average share of market increased by 5 percentage points compared to Q4 2024 and by 10 percentage points compared to the same quarter last year. On Slide 11, we provide an update on capital allocation. Moving to Slide 12 is our updated 2025 financial guidance. Our performance in Q1 was strong, and we are encouraged by the underlying trends we saw across our portfolio of medicines. As a result, we are reaffirming our revenue and performance margin guidance. Our non-GAAP earnings per share guidance is unchanged, except for Q1 charges related to acquired IPR&D. As Dave mentioned, the situation regarding trade and tariffs remains dynamic. We continue to monitor the external environment. However, we estimate that the announced tariff currently in effect will have a limited financial impact, which we have absorbed within our 2025 guide. Now I will turn the call over to Dan to highlight our progress on R&D.

Thanks, Lucas. I'll start with key data from our recently completed orforglipron Phase 3 trial and provide some context on our development plans and timelines for this important molecule. I previously said that our hypothesis was that orforglipron could deliver efficacy, safety, and tolerability similar to the best seen for available GLP-1 monotherapy injectables. I believe the results from the ACHIEVE-1 trial support that hypothesis. Let me start with efficacy. Beginning on Slide 13, you can see the reduction of 1.3% to 1.6% for hemoglobin A1c. Given the relatively low baseline of 8 in this 40-week monotherapy study, patients on the two highest doses ended the study with a mean A1c of about 6.5%, similar to the lowest levels achieved in trials of other monotherapy GLP-1 agonists. In fact, with orforglipron, more than 65% of patients achieved an A1c less than or equal to 6.5%, which is below the American Diabetes Association's defined threshold for diabetes. In a key secondary endpoint, orforglipron also helped people with diabetes lose approximately 16 pounds or 7.9% of their body weight at the highest dose. These data are in line with weight loss demonstrated with existing injectable GLP-1s in patients with diabetes, especially considering the baseline weight and other demographic factors in this trial. Given that the study was only 40 weeks in duration, participants had not yet reached a weight plateau at the conclusion of this study. This result is encouraging as we look ahead to our first Phase 3 readout in people with obesity that we expect in Q3. Most importantly, we were pleased to see the safety profile of orforglipron in this trial. The most common adverse events were gastrointestinal, which is consistent with the GLP-1 class. We did not see any hepatic safety issues in ACHIEVE-1. As you can see on Slide 14, discontinuations due to adverse events were low, with only 4% to 8% of patients discontinuing orforglipron due to adverse events. The slow and stepwise dose escalation we utilized in Phase 3, combined with the relatively long, about 24-hour half-life of this molecule, resulted in a tolerability profile that matched our expectations and was consistent with weekly injectable GLP-1s. The ACHIEVE-1 full results will be presented at the ADA's 85th Scientific Sessions and will be published in a peer-reviewed journal. This was the first of several Phase 3 trials that we'll read out for orforglipron. On Slide 15, you can see how ACHIEVE-1 fits into the broader orforglipron development program. Over the next 12 months, we expect to get results from four additional diabetes trials, where we're studying orforglipron compared to insulin and head-to-head versus other oral diabetes medicines. We also expect to get results in our two obesity Phase 3 trials, one trial in people with obesity without diabetes and a second trial in people with obesity and diabetes. Assuming success in these Phase 3 programs, we plan to submit orforglipron for obesity in Q4 later this year, followed by Type 2 diabetes in the first half of 2026. We also have an ongoing Phase 3 trial in obesity in maintenance obesity, and we will initiate a Phase 3 trial in hypertension later this quarter. We look forward to seeing more data from this robust clinical development program as we continue to find the impact orforglipron can have for patients. Moving on to other R&D updates since our last call. On the regulatory front, following discussions with the FDA, we've withdrawn our U.S. application for the heart failure with preserved ejection fraction indication for Tirzepatide. We believe the positive Phase 3 data from the SUMMIT trial do support an indication. However, the FDA indicated an additional confirmatory clinical trial is required. Regulatory reviews are ongoing in other countries. Continuing with updates in Cardiometabolic Health, we're sharing today plans to initiate a new Phase 3 trial studying our triple agonist, Retatrutide, in patients with obesity and chronic low back pain. We're also announcing today next steps for our Oral Once-Daily program targeting lipoprotein (a), muvalaplin. In Phase 2 data we presented last year, muvalaplin lowered lipoprotein (a) levels by up to 85% at the highest tested dose. Based on these data, we plan to initiate a Phase 3 program later this year in atherosclerotic cardiovascular disease, and we're excited about the potential to bring what could be the first-ever oral small molecule approach for lowering lipoprotein (a) to patients. Moving to oncology, we've now started a new Phase 3 program with Olomorasib in KRAS G12C mutant resected adjuvant lung cancer. This is the third potential indication that we're simultaneously pursuing for Olomorasib. Across our therapeutic areas, we made good progress in our early phase portfolio and we advanced five new medicines into Phase 1 clinical trials as shown on Slide 16. I'll now turn the call back to Dave for closing remarks.

Thanks, Dan. We know uncertainties exist right now in trade, tax, and international relations. While Lilly is actively engaged in shaping the external environment, we're mostly focused on executing our winning strategy, discovering, developing, and making new medicines that can help people live healthier lives. We made good progress this quarter, and we are well positioned to deliver strong and sustained growth going forward. Now, I'll turn the call over to Mike to moderate our Q&A session.

Thanks, Dave. We'd like to take questions from as many callers as possible. Consistent with prior quarters, we will respond to one question per caller and will end the call promptly at 11 a.m. Paul, please provide the instructions for the Q&A session, and then we're ready for the first caller.

The first question today is coming from Asad Haider from Goldman Sachs.

Thanks for taking the question. Dave, just in light of the CVS formulary announcement this morning, favoring Wegovy over Zepbound, there are clearly some investor concerns about the PBM dynamic in obesity given what we've seen in other big healthcare markets in the past where PBMs fit two companies against each other. So a two-part question. Number one, what is your expectation on market share dynamics in the next weeks and months from the CVS formulary loss? And then second, can you talk about your strategy on how you're going to be navigating an environment where we could see PBMs continue to try and restrict formulary access between Zepbound and Wegovy?

Yeah. Thanks for the question. We're not surprised that this kind of announcement was made. If we look at what's happening in the market, we're pretty deep into a replacement cycle, particularly on obesity, and Tirzepatide, as we've highlighted on this call, is gaining a lot of market share; basically, most of the growth in the category is happening with our medicine. Of course, the private pay market is an important segment. We'd like to grow that segment and we'd like to grow choice and access in that segment. So we're not interested at all in one-of-one deals that reduce access and choice for doctors and patients. We want to expand it. So this type of announcement isn't particularly interesting to us, but it's understandable that it can happen and obviously, in this one case it did. Our focus is on making better medicines and more accessible medicines. So our orforglipron is a topic today, and we're excited by the possibility of an oral that could be more widely distributed around the world and here in the U.S., with GLP-1 injectable-like profile like Dan highlighted and of course, on driving more advanced therapies as well, a combination or triple-acting agents like Tirzepatide. So that's our focus. It doesn't surprise me that this has happened, and we'll work through it recognizing in this case as well we're talking about the templated lives at CVS, and probably opt-in rates for employers in the templated part of their book are pretty low compared to the national average, just to maybe inform your analysis, and we'll work through it. Our job will be to continue to drive share and preference for our brand. I think the team has done a great job of that year to date, and we'll continue to focus on that while we wait for the orforglipron launch and read the data later this year.

The next question will be from Geoff Meacham from Citibank.

Good morning, guys. Thanks for the question. For Dan or for Dave, when you look at the positioning of orforglipron, is the ultimate goal to have meaningfully more indications than Tirzepatide, just given the oral convenience? I think when you look beyond just weight loss, it would seem that broader cardio investment makes sense, but maybe also perhaps combos in INI or autoimmune or even neuropsych?

Thanks, Geoff. We'll go to Dan to talk about the orforglipron development strategy.

Yeah. Thanks, Geoff. And I think you're correctly pointing out that oral medicine like orforglipron could be acceptable for use in a number of broad indications, particularly primary care type indications. That's guided our thinking on indications that we're pursuing. I think coming out of this readout, we have even more confidence in this molecule, and we'll aggressively pursue whatever directions we think work. Combinations surely are on the table where that makes sense for patients, particularly in disease areas where there could be synergy with other mechanisms. Probably there are a number of good ideas in immunology and neuroscience, as you point out. Also, just a reminder, Geoff, we it's not our only oral incretin. We have another molecule behind that, and we're continuing to innovate with even multifunctional orals. So I'm pretty excited about what's yet to come here and surely we start with Type 2 diabetes and obesity, but more to come.

The next question is coming from Chris Schott from JPMorgan.

Great. Thanks so much. Just another orforglipron data. Just post the data we've seen here, can you just elaborate a bit more on the role you see orforglipron playing in the core obesity and diabetes market relative to injectables? And maybe as part of that, any thoughts on what type of share you would envision orals taking in the market over time?

Great. Thanks, Chris. We'll go to Patrik to talk about that role of oral in the broader orforglipron market.

Thanks a lot, Chris. I think a significant opportunities here for orforglipron. Just looking at the Type 2 market today, we know that approximately 50% of patients have a preference for an oral, giving everything is equal on the efficacy and the safety side. And similarly, on the obesity side, we know that we have approximately 25% of the patients in the U.S. suffering from needle fear. So I think that positions us very nicely to be a first line in routine for both Type 2 and chronic weight management. The other benefits as well, I think with an oral here, we can scale and reach patients that is more or less impossible with only injectables. So I think it provides a huge global opportunity for us with orforglipron and also from a manufacturing side, probably a significant benefit as well. So overall, I think tremendous opportunities here with orforglipron in Type 2 and obesity in the U.S. and other markets where we have launched, but also to scale globally to an extent we can't do with injectables.

Maybe two quick adds there. In segments that we're thinking about actively, one, of course, we're doing the maintenance studies, which switch people from injectable to oral to maintain weight loss. That's a big unmet need in the market. People like the idea of stepping down and using less medicine. They're trying things on their own now, and we'll have a science-based solution using oral, which we think will be an attractive choice. That data is not in hand yet. We need to wait for that to prove that out. But I think that that's an interesting segment that will probably grow quite large over time, Chris. The other one is reaching segments of the population that maybe have comorbid risk, maybe not comorbid disease, have overweight but not obesity, and don't need dramatic weight loss, but sustained lower body weight is an important factor in their long-term health. And we'll look at studies there. I think the prior question was alluding to that in terms of indications that might be suitable for that space. So we have big ambitions here and, of course, need to see the full data package come in on obesity, but a pretty exciting opportunity.

The next question will be from Terence Flynn from Morgan Stanley.

Great. Thanks for taking the question. Two-part on orforglipron as well. I know you're obviously not going to comment directly on pricing at this point, but maybe just conceptually, if you're delivering the same profile as an injectable medicine, why would you decide to price lower, I guess, given you price to value? And then as you think about having a portfolio of weight loss medications potentially in 2026, does that give you additional leverage with some of these PBM discussions?

Go ahead. Go on the risk curve again, Terrence, with a two-part question, but go to Patrik to weigh in the thoughts on the orforglipron pricing and then the portfolio implications as well.

Thanks a lot, Terrence. I think it's on the pricing. We normally don't comment on that until the time of launch. But I think truly having a portfolio in this space and as Dave shared earlier on oral that we actually could approach patients with a BMI above 27 lower BMIs, if it probably will play as a foundation for treatment of chronic weight management for quite some time to come and potentially as a triple agonist, right, where you could target people with a BMI above 35. And so I think that gives us a position of strength in this marketplace.

Maybe just one policy-related add, like how do we think about pricing forward, especially in a category like this? The past was really about very high list prices and relatively deep discounts to leverage PBM access. And we've been very vocal about trying to move away from that past, basically to have a more transparent, closer pricing between list and net. Maybe important to say that based on this morning's news as well. So we price that down at a discount to the competitor, some meaningful discount on list price, with the idea of trying to squeeze those two numbers together. We'd like to continue that progress so that patients and payers have a more similar basis for cost-sharing and net cost. I think that's a better way forward. So just as Patrik and the team work on pricing strategy, etc., know that in the background, we're trying to push these two numbers together over time, reduce gross to net spreads, have less rebate flow into the channel, and more transparent overall pricing.

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

Great. Thank you very much for taking my question. I think going back to the CVS announcement this morning, there are two ways to look at it. One could be, which obviously the stop reaction is like that. It seems like, I mean, a Zepbound versus the Wegovy kind of price war? Or the other way could be, I mean, looking at CVS comments, it seems like a lot of our employers did not opt in, and CVS is finding a way to actually provide affordable access to this medicine. How do you view this development? And in the longer term, I think, is it better versus GLP-1s you see, or is it a GLP-1s versus the access situation you see this is going to evolve over a couple of years?

Thanks for the question, Mohit. I think, Dave, do you want to elaborate on some of the earlier comments about the CVS virtually?

I mean, I think those are good questions to ask Novo and CVS, really. You're just pointing out that the book of business we're talking about is smaller employers who tend to take the templated formulary, the opt-in rates already are low. So it is possible that, depending on what price CVS is going to offer this client, you could get more opt-in. I think that's a net good thing overall because what we see despite the press is that when employers opt-in, they tend to not opt-out. Employees like to be on these medicines. And there's a big study yesterday you may have seen from Aon, which looked at real-world data, which is very compelling. Within two years, there's ROI and a 40% reduction in MACE events in the real world, etc. So that could be good, as you're saying. On the other hand, I guess we're focused on innovation and differentiation. We see kind of a mega category here that will have many different choices and solutions. And it seems like the wrong idea to reduce choice. Maybe there are patients who are taking Zepbound in one of these formularies and as of July 1, they won't have that choice. I think they'll be quite upset about that. And we'll see how the market reacts and how much share gets moved ultimately. But as I said, our preference is to expand access, not reduce it.

Next question will be from Alex Hammond from Wolfe.

Thanks for taking the question. Just one quick one on TRAILBLAZER-ALZ 3. So during the 4Q call, Dan mentioned that the team is closely watching the preclinical trial and the study will read out when the target number of progression events were accrued. Can you update us as to where we are from that events point of view and remind us of what a successful trial looks like?

Great. Thanks, Alex. We'll go to Anne for the question on the Alzheimer's portfolio.

Yes. Thanks so much for the question on Alzheimer's. And as we mentioned in the past, we have completed enrollment in the TB3 study. And as you said, it's an event-based study, so the timeline for the readout is driven by this. And although our clinicaltrials.gov list is the date in 2027, we believe it could be earlier than that, so we're looking forward to that. Now these are patients who have elevated levels of amyloid but no detectable symptoms, and our goal is to significantly reduce the risk that people ever experience symptoms of Alzheimer's disease. So that's the goal of the study. The actual endpoint is time-to-event of clinical progression, and we measure that by the CDR global score. So really preventing people from moving to the symptomatic stage, which is the stage at which the greatest impact is happening. So what we saw in TB2 obviously got us very excited about the potential outcome here with the fact that patients earliest in disease and early symptomatic did so well and had such a significant slowing of progression (60%). So we look forward to sharing more as the events occur. And again, we'll share more timing when we have those events reached.

The next question will be from Seamus Fernandez from Guggenheim.

Thanks for the question. So I'll go with another non-obesity question. How is Ebglyss tracking against your ambition of it being a best-in-class launch? Is your vision for peak sales in line with consensus sales of $2 billion, or do you see an opportunity materially higher than that? And if not, is the barrier related to Sanofi's claimed rebate wall or something else like the breadth of the label or perceived efficacy differentiation?

Great. Thanks, Seamus. We'll go to Dan to talk about the Ebglyss launch dynamics and some goals for the brand.

Yeah. Thanks, Seamus. We certainly do have high aspirations for Ebglyss. It's a great medicine. We saw amazing data in our clinical trials. I think this prepared us well to take on the market leader in atopic derm, which is a large and growing market. And in the early months of launch, we've seen good uptake as you can see reflected in the numbers. And I think probably most telling is what we're seeing and hearing from physicians. Initially, I think in any launch, people try to treat their most severe patients, people who might have failed other therapies, and when they see good responses there, they move it into the first-line setting. That's exactly the motion we're seeing from physicians. They're happy with the results they're getting, and they're using it more and more. A lot of work to do, and you point out the heavy competitive dynamics, but I like the asset I have. In terms of the rebates and coverage, I think as Lucas said, we're seeing a growing coverage here in the United States, and I think we'll overcome any issues there without too much trouble. So we look forward to broad access and continued accelerating uptake.

The next question will be from Tim Anderson from Bank of America.

Thank you. A question on kind of going back to formulary positioning in obesity. So I know you don't want to play the one-of-one formulary game, but it's still something that might occur anyway because Novo is losing share to you and price is really the only lever they can pull at the moment, and some payers will look at one-of-one as a way to manage spend. I know that some states have already taken that approach, overseeing CVS to it. So really the question is, I guess, of covered lives today, what percent of payers are having this one-of-one approach? And just again, your view for how this is going to evolve going forward whether you like it or not?

Thanks, Tim. For the next question on CVS, we'll go to Patrik.

Yeah. Thanks very much, Tim. You know one-on-one is quite rare in the marketplace today when it comes to obesity. And as Dave said earlier, we deal with contract negotiations all the time, and we're not entirely surprised with the announcement this morning taking into account Zepbound’s strong performance. For us, we will just continue to execute as strong as we can, and I think we have a tremendous momentum in the marketplace with a net switch, but it's quite significant too to Zepbound in the marketplace. We will continue those efforts across the PBMs, Medicaid, and North America and of course our self-pay effort with vials as well.

The next question will be from Evan Seigerman from BMO Capital Markets.

Hi, guys. Thank you so much for taking my question. I wanted to touch on Tirzepatide and HFpEF. The update was a bit surprising today. Can you provide some additional detail on what the FDA wants to see regarding additional data and what you didn't have from the SUMMIT trial to demonstrate a clear enough benefit?

Yeah. Thanks, Evan. We'll go to Dan for the question on the heart failure dynamics.

Yes. Thanks, Evan. It's probably obvious to you as it is to us that that was a study with a really strong and profound benefit for patients. So we're excited about the opportunity to help patients with that. I think from the FDA perspective, they want multiple trials to support this indication. And I think that's probably where we ended it. It's possible we could get additional data from other trials to support resubmission here. On the other hand, just remember that all of the patients in this trial and the proposed indication are already covered under the obesity indication. So it's not a new population to treat; it's rather a new benefit for people that might already be widely understood to doctors today. So it's a bit unfortunate we're in this position and it could have a bit of a curtailing effect on investment in HFpEF, which is a pretty serious unmet medical need. So I'm sorry to see that, but it's kind of hard to think about the incentive for doing large outcome trials in this population that's already covered under an existing indication and the benefits are well understood.

Next question is from James Shin from Deutsche Bank.

Hey, good morning, guys. Thank you for the question. Maybe one for Lucas. I know revenue guidance was maintained, but is the mid to high single-digit price headwind still intact following the CVS formulary decision on Zepbound and also given the movement in FX?

Yeah. Thank you for the question, James. Maybe just jumping into it right away. As you've heard, we are reaffirming our guide for the full year that the midpoint continues to be in that 32% range for the year. We are off to a good start with the strong growth that we see in the first quarter. To your question about the price, yes, again, I mentioned last time, and I'll reaffirm it now, again, that mid to high single-digit price erosion; we've seen that in the first quarter, by the way, minus 6% in price. So it's very consistent with what I shared in the last earnings call. So overall, I think that perspective has not changed both in terms of the guide and our expectations on price for the year. Maybe just again, to provide a little bit more perspective on how things evolve and how we think about the guide; there are always dynamics taking place during the year as you can imagine, and we factored those ones as part of our forecasting process. So, as Patrik alluded, we are not surprised by this, and again, we will continue to navigate. We feel strongly about the update that we are seeing nowadays, and we will continue to navigate through this throughout the year.

The next question will be from Umer Raffat from Evercore.

Good morning, guys. Thanks for taking my question and congrats on recent orforglipron updates. I had a question or two-part question on orforglipron safety. First, I recall you mentioned no hepatic safety signal was observed and no Hy's law. Could you confirm there was no numerical imbalance on ALT above 5x? And on diarrhea, I recall it was in the low to mid-20s across the second highest and highest dose. How should we think about that heading into the obesity trial, especially with a longer duration?

Thanks so much for the question on the safety profile for orforglipron.

Okay. Those are very specific questions, which I may not precisely know the answer to, honestly. But as far as the overall liver safety profile, including kind of mean changes and excursions from the mean we didn't see anything of concern here, and it looked very similar to placebo. So I think we feel confident that additional data readouts are coming, of course, but so far, so good. I think with respect to rates of diarrhea, you're pointing out that they were a bit higher in this study than we've seen in previous studies. They were also higher in the placebo rate. I think we might need to move to an understanding of diarrhea rates as a sort of a ratio of drug to placebo because they could be pretty variable depending on the country that you enrolled the trial, and we saw that effect in this study with some countries having very high diarrhea rates in placebo and drug and also the way that's ascertained by the investigators. So I didn't see anything of concern there, but I do need to emphasize that across the Lilly trials we seem to have slightly higher diarrhea rates than others. But let's see what we observe in the obesity trial. That's not the main focus here. Probably the more telling indicator of tolerability is going to be discontinuations due to adverse events; that probably matters the most in the real world.

The next question will be from Steve Scala from TD Cowen.

My recollection is that Lilly used aggressive formulary positioning as a lever with Taltz against other IL-17 competitors and, therefore, reduce choice. Would you refresh our memories on what that did for Taltz in terms of share and incremental sales? And if you're willing to, at what discount? And how can that experience inform us on the outlook for Zepbound and Wegovy on the CVS formulary?

Great. Thanks, Steve. Dave, we'll go to you for the history on BioMeds.

Yes. Looking back nearly a decade ago, we lost Taltz and I have a different recollection of that period. I was responsible for it then, and we found ourselves in a situation where we were following rather than leading. Our goal was to transition from a one-on-one competitive stance to being two-of-two in a new category, and I believe we largely achieved that in the first few years. However, the landscape has evolved with the introduction of IL-23s and a new IL-17 competitor, leading to one-on-one scenarios. It's worth noting that such payer behavior is more typical in the pharmaceutical industry when there are more than two players and product profiles that are clinically similar. In contrast, the obesity market does not reflect either of these conditions, so it will be interesting to see how this plays out. We anticipate more differentiation ahead, which will create a demand for greater choice in the market rather than less. Our strategy has never focused on using payer channels to exclusively drive market share, even when we had significant clinical advantages, as demonstrated by Jardiance where we aimed for multiple options within that class. So, I remember things differently than you, Steve, even though you have considerable experience. While there were instances of one-on-one competition with Taltz, that was not our preferred approach, and we often did not offer different rates to achieve it. We are committed as a company to providing more options, especially where innovation is thriving, and we have a lot of new advancements on the horizon that are beneficial to us.

Next question will be coming from Courtney Breen from Bernstein.

Perhaps just following on from Steve's question as well. Can you clarify for us because I think a number of investors are concerned, and obviously, we see that in the share price today. How many current patients on Zepbound are being covered by CVS Caremark today?

Thanks for the question, Courtney. Maybe give some color on the rough magnitude, Patrik, on the CVS Zepbound dynamics.

I don't have a specific number of lives to share today, but we need to consider that it's not the entire CVS account. We're referring to a subset of plans mentioned earlier by Dave. Additionally, we need to assess the level of employer opt-in for those plans, which we believe is not very high. That's the guidance I can provide today. We will continue our efforts to increase employer opt-in across other plans and segments, but that's all I can share for now.

The next question will be from David Risinger from Leerink Partners.

Yes. Thanks very much. So I'm hoping that you can comment, Dave, on discussions with the Trump administration on tariffs outside of the 232 investigation. So the driver of my question is that the countries of origin for Lilly's drugs IP and API are obviously not in countries that represent national security threats. And I'm curious about the discussions to satisfy the Trump administration's interest in having drug companies record more profits in the United States and generate more tax revenue in the United States?

Thank you, Dave. Please proceed.

You are correct to note that the Section 232 mechanism focuses on national security, and this is the current standing of the pharma review. Additionally, there is a plan within the administration to bring the supply chain back, which we support. There is also the challenge of generating revenue during the reconciliation process. Regarding these three points, the 232 review holds value, especially when we examine the many widely used generic medications, some of which were originally developed by Lilly or other innovative companies but have since been sourced offshore, from single-source suppliers, and potentially from countries where future conflicts could arise. We recognize this issue and the branded industry is willing to address it. Essentially, this revolves around market mechanisms where proper pricing is not established, preventing a viable onshore presence until that changes. In cases of emergencies, collaboration may be possible. There are significant questions about whether implementing tariffs would effectively shift the supply chain, which might be a focal point of the review. We hope that the 232 review will be relevant to this discussion, and we will continue to explore it. This approach will naturally rebalance our sourcing and provide more options. While tariffs might have a temporary effect for Lilly, we doubt they will have a lasting impact. As mentioned earlier, the real solution lies in addressing the income tax gap that created the issue, particularly when comparing the U.S. tax rate of 35% to Ireland's 15%. Therefore, tax reform is crucial for a long-term resolution. Within Lilly, we have proactively invested to mitigate this issue. On the topic of revenue generation, our industry contributes significantly to income tax, and due to the 2017 Tax Cuts and Jobs Act, there is a minimum global tax in place that applies to foreign-sourced income, which means our tax situation remains unchanged whether we repatriate income or not. This has consequently led to increased tax rates in other countries over the past seven years. We believe we are well-positioned among our peers. These matters are complex and cannot simply be reduced to sound bites. The 232 process is substantial, and the trend of bringing operations back to the U.S. is already in motion for both the industry and Lilly. We hope to avoid discussions around tariffs and would prefer to see the tax bill passed for normalization.

The next question is from Kerry Holford from Berenberg.

A question on the cash pay approach in the U.S. is regarding CVS's announcement that its pharmacists will stock the Wegovy cash pay pens. My question is whether Zepbound cash pay vials are currently available in any pharmacy chain in the U.S. Given your enthusiasm for cash pay opportunities, are you considering additional channels beyond your online LillyDirect portal? Would this be a possibility within pharmacy chains in the U.S.? Additionally, will you eventually offer the Zepbound pens via the cash pay route, or do you plan to maintain that separation?

Thanks, Kerry. Related question, again, getting close to the line there. But Patrik, do you want to take the question on the vials, the cash pay distribution and if we would ever think of other formulations?

I think we're very pleased with the performance in our self-pay segment. And if we look just on Q1, we had revenues above $200 million, and 25% of the NBRx for Zepbound are initiated in Q1 through self-pay, and 17% of the entire market NBRx are in self-pay. And I think we stated from the beginning when we launched LillyDirect that we did it to remove friction for patients and that we will continue to add products, add services, and other components. I think you should expect more to count LillyDirect. I don't have anything to announce today. But I would just emphasize that the price change that we announced earlier this year and the launch of high-dose vials have significantly contributed to an even further acceleration of the market growth. So I think we are doing something here to really enable more patients to access both medications at a relatively competitive price.

The next question will be from Akash Tewari from Jefferies.

It seems like your team is really going after the 75% of Americans who are both overweight and obese. Would long-term net pricing have to approach insulin levels for that to become a reality? Additionally, the Street models long-term margins going above 50%, while your team has been insistent that the 40% to 45% range is really sustainable. How much of that delta is really us misunderstanding your volume over price approach to GLP-1s long-term?

Thanks, Akash. We'll go to Patrik and then potentially Lucas to talk about both pricing long-term and margins.

I would say, when we look at the overall portfolio, I think we have stated from the beginning that we will continue to take a very disciplined approach here but also what Dave shared, we probably see an evolution here where you see a delta in between this price and net price of patients. And I think that's pretty much what's guiding us from a portfolio perspective moving forward.

Yes. And I already commented from the pricing perspective, I think the price impressions are consistent with the trends that we have seen in the last 12 months, and that's what we are forecasting moving forward. This is a very dynamic situation as well, but we remain disciplined in our approach to provide optionality and have an open access for patients.

The next question is from Trung Huynh from UBS.

Just on orforglipron obesity expectations. So in a similar way to outlining your thoughts on the orforglipron diabetes ACHIEVE data, how you thinking about the weight loss for orforglipron in the ATTAIN obesity studies? And on the tolerability side of things, can you just give us any color on when you had those GI side effects and discontinuations in ACHIEVE, was it early or later, just thinking about how tolerability could be from the ATTAIN versus ACHIEVE studies?

Thanks, Trung. We'll go to Dan for the orforglipron questions.

Yes. These are important questions, particularly the expectations for the obesity study, and probably just to remind people that this is a monotherapy GLP-1 agonist, not a dual agonist like Tirzepatide. So we need to expect a weight loss that could be seen with GLP-1 monotherapy, which, as we showed in SURMOUNT-5, is quite different than what you get with two actions that Tirzepatide has. So SURMOUNT-5 was a 72-week trial in obesity patients that Lilly ran that included monotherapy GLP-1 injectable in the form of semaglutide up to 2.4 milligrams. And I think in that study, we achieved about 13.7% weight loss with the GLP-1 monotherapy. This is a similar trial. It's not exactly the same for orforglipron, but we should expect to be somewhere near that. I think on tolerability, that study also had about 20-some percent of the patients, maybe 21% of the patients with vomiting, which is probably the most reliable indicator of GI tolerability and the most consistent across trials. So that's our expectations. Again, it's still to match the best available data from an injectable. And in this case, I focused on the trial that we conducted since we're conducting this trial with orforglipron. With respect to when did the discontinuations and tolerability events occur in the previous study, I think it was pretty similar to what we've seen in the past with injectables that usually these things happen early in the study and when people increase their dose, actually, some of the difference between the top two doses was probably just a chance because it happened pretty early in the study when patients would have been on the same dose levels during the escalation scheme. So nothing of concern there. I think if we saw a different pattern with the events happening late in the study, that would be more concerning, but that is not what we saw.

Great. Thanks, Dan. We're going to try to do a couple of more quick ones. So next question, please.

The next question is from Carter Gould from Cantor.

I appreciate all the upfront commentary on tariffs. I guess, Dave, given your unique perspective in Lilly's active role in shaping policy, it's somewhat surprising we didn't hear you talk about some of the drug pricing risk. I guess anything you can share there around if you think potential MFN legislation is a priority or possibility in the coming balance of the year?

Well, I think it's always a risk for the industry. I think we point out that it's not coherent to have a discussion about that without talking about real net pricing versus real pricing in Europe, and that pulls you into a PBM reform discussion and a 340B discussion. So it's a complicated matter. I think you have to ask what would be the vehicle for such a thing. And there's certainly appetite in both parties to pursue this. Our goal, by the way, long-term is to make sure that we can have a discussion, as I mentioned earlier, about trade with Europe that would really change how drugs are priced in that continent, and developed economies pay more for the R&D cost. That's the real answer here. But I think right now, we're hyper-focused as an industry on fixing the IRA problem that was created as to small molecules. I think our enthusiasm for that policy change is high, and that will be the focus on the build that's being contemplated now in May to get out of the house. So that's the focus today, and we'll try to manage the risk you're talking about in the background all the while pointing out that it can't be independently looked at a list price in the U.S. versus Europe; it's a nonsensical idea.

The next question is coming from Rajesh Kumar from HSBC.

Just on access and coverage of Zepbound, could you update us on how that looks now compared to, say, a year back, same time, how many more patients have coverage in the U.S.? And what are the next steps, especially in light of compounders being blocked from selling campaign products, which are no longer allowed for Lilly products at the moment?

So we’ll go to Patrik for an update on Zepbound access progress.

Thanks very much. I think we shared earlier about the formulary access is probably the easiest step, and the more challenging step is going to get employees to opt-in. And we've made some significant progress there in 2024. We started the year with approximately 50% of the employers opting in. And by the end of 2024, we were at mid to the high 50s. So progress there on employer opt-in. But also in other segments, in Medicaid, we have actually moved from 11 states being covered by the end 2024 to 14 states covering now an incremental state Medicaid that have opted in in April, specifically for OSA. And on OSA, we know that the CMS has issued guidance that plans can reimburse for OSA, but they have 180 days since approval, which took place late December last year. We expect some progress in Medicare as well during the second half of this year. In terms of compounding, I think it's really hard to assess the magnitude of that market. But I think a couple of important cuts here: not all of those patients are necessarily on label; and B, that is also a matter of pricing, and we believe that our price point of 349 is actually quite competitive. And thirdly, in terms of the overall presence in the marketplace where we currently have a strong momentum with more than 75% of patients starting anti-obesity treatment starting on Zepbound. So I think we'll continue to execute along those lines across all segments, and we see progress being made every week.

Last question today will be from Kripa Devarakonda from Truist Securities.

I have a question about the Bimagrumab Phase 2 trial, which is expected to be completed by June. Any update on when we might see data? We've heard the potential to see data in June at a conference. Also, can you help set expectations for the data?

Thanks, Kripa. We'll go to Dan to talk about the Bimagrumab.

Yes. Thank you for the question on Bimagrumab. There are actually two Phase II trials. The first one that was conducted actually before we acquired the asset was in combination with semaglutide. That will be the data that will be disclosed first. The ongoing trial is in combination with Tirzepatide. And of course, that's the trial of greater interest to us, and I don't think we've commented on when we might disclose that data. Remember that this is an agent that was designed to see if we could have a positive effect on lean mass as well as a decrease in fat mass. And so that's what we're trying to see how that works in combination with these drugs.

Thanks, Dave, for closing comments.

Okay. Great. Thank you all for participating today on our earnings call and your interest in the company. Please follow up with the IR team as you have questions, which I'm sure you will after today. Everyone have a great day. Take care. Thank you.

And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00 p.m. today running through June 5 at midnight. You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 538637. International callers can call (973) 528-0005. Again, those numbers are (800) 332-6854 and (973) 528-0005 with the access code 538637. Thank you for your participation. You may now disconnect your lines.