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Earnings Call Transcripts

Eli Lilly and Company

LLY
Quarters2 Quarters
ContentQ&A Sections
SourceEarnings Conference Call
Quarter 1

Q1 2026 Earnings Call — April 30, 2026

Management: Thank you, Dave. We'd like to take as many questions as possible. So consistent with prior quarters, please limit yourself to a single one-part question. Paul, please provide the instructions for how to join the queue, and then we're ready for the first caller. Thank you.

At this time, we will be conducting a question and answer session.

If you have any questions, please press star 1 on your phone

at this time.

Again, we ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star 1 at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. And please hold while we poll for questions.

Analyst Name (Firm): The first question today is coming from Jeff Meacham from Citi. Jeff, your line is live.

Analyst (Citi): Hey, guys. Congrats on the quarter. Thanks for the question. Maybe this one is for Dave. You know, investors seem to be acutely focused on pricing in incretins with not a lot of emphasis on volume. I know you don't want to get too specific, but when you talk about, you know, at a high level, the margins under a wide range of price scenarios for For Lily, how do you see the investments you've already made in, say, manufacturing, and how does that add to the dynamic and what that means in terms of the competitive mode? Thanks.

Executive Name (Title): Great. Thanks, Jeff. Dave, do you want to talk about pricing and anchor towns?

Executive (Title): Sure. Thanks for the question, Jeff. Maybe a couple things to point out now that we're five or six quarters deep into this sort of post-shortage world, and we can really pursue expansion on volume in an aggressive way. I think you can see something It's a little different about the obesity and weight loss category from what we think about in other pharmaceuticals, where the barrier is typically more informational, not price sensitivity. But here, clearly, because of the out-of-pocket nature, 75% of ex-U.S. business for Montero is out-of-pocket. U.S. is a meaningful portion as well. We see quite expansionary volumes, perhaps nonlinear, to price reductions. Of course, there's a floor on that, and we have sensitivity on our cost structures, et cetera. But pretty much every time we reduce pricing, we see a pretty large expansion. You also see built into this the primary pricing affecting Q1 are actually negotiated outcomes with governments, both the MFN package we negotiated with the Trump administration, your cut out-of-pocket costs, you see strong growth. Like Lilly's Upbound Biles really had quite a strong quarter in Q1 at slightly lower prices.

And then in China, we negotiated for diabetes access and a meaningful price reduction, but you can see the volume far outstripping the price concession. So kind of a different dynamic. And I think if investors can think about this category, perhaps unlike other pharmaceutical categories in the past, you know, in terms of margin sensitivity, it remains true that, you know, for this category, for us at least, the unit economics are really driven by fixed costs that are either sunk in the past or unmovable depending on the volume in the present. And as a result, you know, both covering the amortized R&D costs as well as CapEx is a concern from an accounting perspective. But at the margin, we do have latitude. You know, that said, we want to invest in future medicines. And I think that's probably the biggest, as we've said before, as we think about long-term operating margin for the company, you know, the X factor. If we have good projects, we won't hesitate to invest in them, whether it be existing medicines. I think you see kind of a record load of phase three Nilex at Lilly right now, or for new medicines.

And we've got a very full phase two and phase one pipeline that we are deploying capital against. So we've got a lot of latitude here, Jeff, and I think this market works a little differently, and we're all sort of just getting used to that. But I think good news for Lilly in our incumbent position.

Management: Thank you, Dave. Paul, next question, please.

Analyst Name (Firm): The next question will be from Chris Schott from J.P. Morgan. Chris, your line is live.

Analyst (J.P. Morgan): Thanks so much for the question, and congrats on the progress. I just wanted to dig a little bit more into international Manjaro. And can you just share some of the learnings from, I think it's been a much better expected launch than we all had anticipated here, as we think about the ramp going forward and longer term opportunity. And maybe as part of that, can you just, should we expect any impact to the ramp from the entry of generic SEMA in select markets? Or is this such an early stage of penetration where that's less relevant? Thanks so much.

Executive Name (Title): Great. Thanks, Chris. For the question about international Monjaro and the potential impact of generic SEMO, we'll go to Patrick.

Executive (Title): Thank you very much, Chris. You know, when we look at the first quarter, it's truly a strong growth of all our prioritized products across international, but of course, particularly Monjaro. And now we have fully launched in more than 55 countries, and we have seen a very strong speed of uptake and also a rapid market share gain. Also in the market, we launched the second half of 2025, referring to Brazil and Korea, where we currently have an estimated market share of 60%. And of course, also the China Type 2 NRDL reimbursement. When we look at the generics, we only have a few weeks of data from India. But it seems like it's really stimulating the growth in the overall obesity market. And that includes our product. And the Monjaro has actually been holding market share quite nicely. When we look at the Monjaro prescriptions, they are about 10% higher in recent weeks compared to the period prior to generics entered. So I think it just underscores that dual agonists Trump's single agonist. Moving forward, I think we should expect a very strong continued year-on-year growth and some sequential growth.

We saw in the slide earlier that we have a market share above 53% OUS, and that's an average. And in many international markets, we have a market share along the lines of what we see in the US with SEPA. And when you get to that level of share, incremental share gain is getting harder. And, of course, we will focus our efforts on patient activation, driving increased penetration in the chronic weight management market and market growth. And also, secondly, what we have seen during the second half of the year has been some seasonality, mainly driven by the holiday season in Europe, where patients tend to take a drug holiday break or actually delay that initiation of the new therapy start. But overall, strong growth across regions. Seems like generic semaglutide is stimulating market growth, and we continue to do well. We expect a continued strong year-on-year growth, sequential growth driven by patient activation.

Management: Great. Thank you, Patrick. Next caller, please, Paul.

Analyst Name (Firm): The next question will be from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Analyst (Guggenheim): Oh, great. Thanks for the question. So really, we just wanted to get a better understanding of how the market, as you see it, is starting to segment and could segment going forward. More as you look forward to the potential introduction of Reta True Tide amidst the Foundio launch, as well as then the follow-on to that being the LRL and Tunch. Where do you see the market really opening up with each of these potential assets reaching forward? Thanks so much.

Executive Name (Title): Great. Thanks, Seamus. For that question, we'll go to Ken to talk a bit about the portfolio and how we see the market segmenting.

Executive (Title): Yeah, sure. Thanks for the question, Seamus. I think it's reasonable to expect in this large and growing market and opportunity in obesity that with, you know, the number of patients around the world living with overweight or obesity numbering perhaps in the billions, that many of them are going to want different types of medicines that are tailored to their individual needs and preferences. We're in early innings in that regard. We're now sort of bringing the third segment, I guess, in. We've had GLP-1 single agonists and then dual agonists and now oral medicines, but we see many other sort of plausible opportunities to tailor medicines to different groups. As you noted, retichutide is one of those ideas which very obviously could play to individuals who are seeking greater weight loss, although I will say we see opportunities for retichutide elsewhere and across the spectrum of obesity. Eluralentide, we can position that a few ways based on the Phase II data that we've seen.

The first of which is that this could be a great medicine for patients seeking a non-GLP-1-based mechanism, perhaps due to tolerability they've experienced or tolerability that they're fearful of. It may also be a good drug that could be added on top of existing incretin therapies to provide incremental weight lowering. But there's many other ideas out there Lilly's investing in. That includes medicines that could be dosed even less frequently, perhaps those that dial in additional metabolic benefits, and maybe some that are sort of ultra-long acting using genetic medicine approaches. We see all of these as compelling ideas, and we also feel we're in a leading position in most, if not all, of those spaces. You know, in terms of how the market will ultimately shake out in terms of percentage of use across those different ideas. It's hard to prognosticate that, but many of these ideas are tied to common manufacturing platforms, and we're making the investments to support any of them, should they prove to be really the most favorable option for managing the overweight and obesity.

Management: Great. Thank you, Ken. We'll go to the next question, please, Paul.

Analyst Name (Firm): The next question will be from Alex Hammond from Wolf Research. Alex, your line is live.

Analyst (Wolf Research): Good morning, guys. Thanks for taking the question. On Medicare Access, can you walk us through your strategy to activate these patients? And when do you kind of see this playing out in terms of either maybe a 4Q dynamic or more of a 2027 as these patients pull through? And I guess as well, with the attractive price point, how do you think about persistence in this population?

Executive Name (Title): Okay. Thanks, Alex. For the question about Medicare access and sort of staging over time, we'll go to Ilya.

Executive (Title): Great. Thank you for the question. Obviously, we're excited about having Part D access starting to activate for obesity medicines starting in July. In the way that we think about it, there are millions of R&D beneficiaries that are eligible. And so the path to that with having a long trajectory with a big program of not only starting in July but all through 2027 is an important aspect. Obviously, that will take time to build. We need to have the education across physician-based pharmacies as well as consumer-based to understand the full path of different medicines that we have and available for treating obesity. And so that'll be a gradual path in 26 as it starts and then continued growth in 27. And obviously the $50 a month copay is an important element of affordability for seniors. We've already seen for ZepBound as well as Manjaro that they've had great persistency overall relative to other chronic conditions. And we continue to see that. Obviously, the $50 copay and affordability will only just add to that in addition to all of the health benefits and experiences that people will have over time. So we're excited about expanding access very soon.

Management: Great. Thank you, Ilya. Next question, please, Paul.

Analyst Name (Firm): The next question will be from Evan Siegerman from BMO Capital. Evan, your line is live.

Analyst (BMO Capital): Hi, guys. Thank you so much for taking my question. Bigger picture, strategically, as you think about the next levers of growth for the business, what do you need to see from either the INI, neuroscience, or oncology franchises to kind of match the scale of the obesity metabolic businesses or particular assets? Is it BD or something else? Thank you.

Executive Name (Title): Great. Thanks, Evan. We'll go to Dan to talk about some of the important programs that he's focused on to drive growth in the future.

Executive (Title): Yeah, thanks, Evan, for that question. And it's an important one to us. As far as you're asking about scale, but I point out in growth rate, those businesses are growing extremely fast. Even without the obesity and metabolic business, Lilly would be the fastest or certainly one of the fastest growing pharmaceutical companies in the industry. So we're proud of what we're doing in those three areas. And I think each of them has very significant unmet medical needs that we can scale into as our medicines are successful. So we like what we got. We like the direction we're going. Of course, in each of those areas, we also see opportunities to get a lot bigger, and we've highlighted some of the themes already in those areas. You'll also see us address some of that through business development. So, for example, the Sintesa acquisition allows us to play in in a new area here in sleep-wake medicines. The WARNA acquisition allows us to play in new areas of immune reset, for example.

Management: Great. Thanks, Dan. Next question, please, Paul.

Analyst Name (Firm): The next question will be from Asad Haider from Goldman Sachs. Asad, your line is live.

Analyst (Goldman Sachs): Great. Thanks for taking the question, and congrats on the continued strong execution. Maybe just going back to Fundayo, appreciate all the color on early launch dynamics, which is sort of playing out along the lines of your messaging, that the initial launch trajectory is going to live below that of oral Regovi, but then there's going to be an acceleration as we move into the back half of the year. So just now with a few weeks of launch under your belt, I think you said 15,000 patients have started taking the drug already. What's your level of confidence on that launch curve framing in the context of the early experience? And then Related on the guidance range, are you able to provide any high-level commentary on what type of contribution was factored in for Fundayo, recognizing that you said that the revised range reflects mainly the strong underlying performance of Manjaro and Zepan? Thank you.

Executive Name (Title): Great. Thanks for the question, Asad. Ilya, do you want to talk about some of the early launch metrics that you're tracking and the feedback you're hearing, and then maybe just a short comment from Lucas about the guide?

Executive (Title): Sure. Well, first, it is early days, but we're pretty pleased with the trajectory and encouraging first start to launch. Obviously, we just started active Salesforce promotion just over a week ago, having broad availability in the supply channel just two weeks ago. Really, we're encouraged by the initial leading indicators. And the way that we think about it, there are probably three key factors and catalysts of growth. And those three are, one, growing the familiarity among healthcare providers, on the clinical profile of Foundeo, building out the access and growing the awareness of Foundeo with consumers. And we're making progress on all three fronts. And so on HTPs, if you think about the early indicators, we now have over 8,000 prescribers of Foundeo, a third of which who have not previously written an oral GLP-1. And so this is expansive. And the current sentiment so far, what we're hearing is really positive on the overall efficacy and kind of the no-hassle factor on a daily oral GLP-1. So that's an important aspect.

We'll continue on the execution related to HCPs around sampling, continued promotion through our sales force, as well as educational seminars, and we're fully in the field with our promotional efforts with HCPs. So good progress there. On access, we've confirmed commercial access at two of the large PBMs by middle of May, so just in a couple of weeks, and To the earlier question on Medicare, Medicare access will start at the beginning of July. And so those are continued catalysts of growth upcoming in the next couple of months. And so we see that as an important unlock and expansion as well. And then on the third piece on consumer front. We now have just over 20,000 patients treated to date. And one important element there is that 80% of those found AO prescriptions are new to class. So this is expansive in bringing new people into being treated for overweight or obesity. We've done a number of aspects already around the direct-to-consumer on digital, on social media, and others. But obviously, we will continue those efforts on a full-scale direct-to-consumer and TB launch in Q3.

Important there is just to ensure that prescribers have familiarity around the profile of Foundeo before we do that. So bottom line, I think we're pleased with the progress. Early indicators are positive and moving in the right direction, and the trajectory will build over time. This is a new brand, new medicine that we're bringing to the market. So we're pleased and ready to go. Maybe on the second part, going to the guidance, just to highlight a couple of things. Of course, again, the increase on our guide is driven by the strength of the entire portfolio that we mentioned during the call, starting, of course, with the Incretin portfolio, both in the U.S. and OUS. In terms of Fundello per se, you've heard already from Ilya about how we continue to see progress and very encouraging feedback that we hear from payers, physicians, and patients as well. We set up the plan at the beginning of the year, and it's very early days. We have three weeks of data

at this time.

So it's tracking to our expectations, and we will continue to see how this progresses over the year. But we feel very confident on the trajectory that we've seen so far.

Management: Great. Thanks, Lucas. Paul, next caller, please.

Analyst Name (Firm): The next question will be from James Shin from Deutsche Bank. James, your line is live.

Analyst (Deutsche Bank): Hey, good morning, guys. Thank you for the question. This one's for Dave. With Bridge extending into 2027, Dave, what's next for balance? Is Lilly working with stakeholders on revisions to secure longer-term Medicare access? Thank you.

Executive Name (Title): Thanks, James. Dave, do you want to share a few comments about the Bridge balance dynamics?

Executive (Title): Sure, yeah. Look, when we signed the agreement with the administration, we all knew Bridge was going to be put in place because it was a mid-year launch. And we had understood at the time that there was a commitment to 27 if, as a contingency, the Part D plans did not choose to opt in at a certain rate. Of course, we now know they didn't. And maybe that's not so surprising. You know, they operate on their margins. There's been other disturbances and market events in the Part D program, for instance, the IPA products, et cetera, that have changed their economics. And unfortunately, I guess, not being a part of those discussions, but they couldn't cross with the major players for calendar 27. So the government's doing what they said, and they're extending bridge. I think for manufacturers, there's some puts and takes in that, but the fact that there'll be access to the consumers at $50 a month, I think is a very compelling proposition, as Ilya highlighted before, will drive great persistency. And in an 18-month window, I think we will start to see growth population-level health improvements if these are used at scale. That will then set up the 28th discussion.

I would expect the government to lean hard into getting Part D plan participation in 28 and normalizing obesity care as a standard preventative treatment and something that should be used to treat comorbidities of obesity within the senior population. We may have the evidence to support that as we exit 27. It may need a little more time, but I think they're going to push to help make that happen. And I think that normalization is overdue in the commercial market, so it'll be a good leading indicator for us across the U.S. business. We'll continue to work with the government closely through that period and, of course, try to work with them to activate patients and make sure they can find success on our medicines. So stay tuned. Probably more news as we exit 27. 26 on the actual 28 plans.

Management: Great. Thank you, Dave. Next question, please, Paul.

Analyst Name (Firm):

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

Analyst (Wells Fargo): Great. Thank you very much for taking my question, and congrats on the progress. I just want to touch upon the Employer Connect program that you are embarking upon. So it seems like the insurance, commercial insurance, has been relatively stable year over year. So this seems to be the way to grow it. And employers are worried about, you know, their costs long-term and everything. So we'd love to understand what are the steps to convince employers to buy into the Employer Connect program and the mechanics of it. Thank you.

Executive Name (Title): Thanks, Mohit. Ilya, do you want to make a few comments about Employer Connect and the progress and focus?

Executive (Title): Sure. Thanks, Mohit. Yeah, listen, as you mentioned, the overall commercial access has been pretty steady around 50% and one of the key aspects that we're excited about is having a employer connect platform where we work with a number of third parties to actually go out and talk to different employers about the value of covering obesity care but there are several things that are a little bit different with our employer connect program one is a transparent price that is known and to all of the employers, and providing the flexibility and design around the employer-employee contribution towards obesity coverage. And so we do think that this is a positive element to increase the number of employers to opting in. Obviously, the selling cycle and the timeline for making decisions for 26 has already passed. So while we are currently having positive conversations and positive feedback from employers around this new platform that will most likely have a gradual impact in the back half of 26 and most likely incremental opt-ins for 27. And then as part of that, obviously there's more data on real-world evidence and also components of where employers do cover what are the benefits to their employees overall, both in their health and productivity over time. And as that data comes out, that will only reinforce the positive decision to provide coverage for obesity care.

Management: Great. Thank you. Next question, please, Paul.

Analyst Name (Firm): The next question will be from Terrence Flynn from Morgan Stanley. Terrence, your line is live.

Analyst (Morgan Stanley): Great. Congrats on all the progress. I had a question broadly. You talked to the portfolio that you're going to be, you currently have, but you're also rolling out across the Ingridton area. And so as you think about the evolution, I guess, of the DTC channel, what are some of the things you're considering to kind of leverage Lilly's scale in that channel? And then also anything that you think will help there from a commercial side in terms of driving additional coverage in terms of having scale across the portfolio? Thank you.

Executive Name (Title): Thanks for the question, Terrence. We'll go to Dave to talk a bit about the portfolio strategy and leveraging DTC.

Executive (Title): Sure. And Ilya and Patrick can jump in here. I think you're pointing out something that has evolved and been developing part of the story here for our growth, which is consumers wanting to take charge of their own health and activate the digital platforms to control weight and obesity. I think this is here to stay, and it's a big part of our business now and probably something we need to continue to invest in. We're doing just that, so you should expect continuous improvement in that experience for consumers in the U.S., and then expansion nationally with the current offerings. I would also say, you know, this notion as we move into other kinds of medicines that could be more preventative could be quite a useful platform to reach more people. We all know that the financing of the current healthcare system is a struggle everywhere. And with, you know, all the noise around PAs and other barriers to care people need, people want to take it in their own hands. And I think, of course, we need to do that within the confines of the regulations and law, but there's a lot of room for improvement for consumers and It's a great outlet potentially for us. So let me ask Ilya or Patrick to add to that if they have anything to add on Lilly Direct and our offerings.

Executive Name (Title): Yeah, sure. Just maybe a few key components of what we've seen on Lilly Direct. Even with Zetbound, you've seen that currently around 55% of new patient starts are coming through self-pay for most of which is coming through Lilly Direct or telehealth players, which is a component of reducing some of the frictions in place. And even early in our launch of Foundeo with limited promotion, we're seeing that that reduced friction level and understanding direct to the consumer is an important lever. About 45% of our volume for Foundeo early on is coming through Lilly Direct. And so we continue to look at ways to improve on the experience for both providers and for consumers in the way they get their and enter their journey for disease, and obviously it plays a significant role for obesity currently. Similarly outside of U.S., I referred earlier to us being at a very high market share in most of the markets already, and patient activation is going to drive most of the coming growth. And we have seen that the markets are responding to patient activation efforts, although it's a slower ramp, but that's going to be key, taking into account the low penetration of incretins outside of U.S.

Management: Thank you. Let's move to the next question, please.

Analyst Name (Firm): The next question will be from Umair Rafat from Evercore. Umair, your line is live.

Analyst (Evercore): Hi, guys. Thanks for taking my question. I thought I'll spend a quick second on Zeb Bound's commercial dynamics in U.S. And really what I'm trying to understand is, for example, 1Q, 7 million TRX and 4.1 billion sales for Zeb Bound in U.S., meaning it's about $580 per prescription. And even if you adjust for some of the one-timer adjustments, it's still about $550 per RX, whereas we understand the cash-pay prices to be about $450 or so, and we know prices, too. I guess what explains that delta? Or maybe IMS is just not capturing some of your online channels. Thank you.

Executive Name (Title): Great. Thanks, Umar. Lucas will talk a bit about pricing dynamics in the U.S.

Executive (Title): Yeah, Umar, thank you for your question. And quick math, your math is pretty spot-on, by the way. So... Just to highlight, yes, and even normalizing by these period adjustments. First of all, again, going back to the initial question on pricing, if you carve out what we agreed on MFN side as well back in November, and then the NRDL access, prices have been relatively stable quarter on quarter. I think it's going back to what we discussed last time about maintaining that price discipline. We continue to see that happening while we continue to grow significantly on the volume side as well. And yes, again, going back to your analysis on the pricing, yes, you have the Lily Direct prices that, as you know, we have adjusted down starting in December. And those prices have been very stable on that front as well. And then the rest, basically, by difference, you get into the commercial business, mainly that that's the different portion that it gets to that net 550 that you highlighted. Maybe just one add. I think that isn't widely appreciated. There is a reasonable amount of medical exception and OSA usage that moves across channels at close to an undiscounted price. So I think that's probably the piece of your math, Umar, that you might want to take a look at.

Management: Great. Good add. Thanks, Dave. Next question, please. We'll try to get through a couple more if we can.

Analyst Name (Firm): The next question will be from Courtney Breen from Bernstein. Courtney, your line is live.

Analyst (Bernstein): Hi, guys. Thanks so much for taking the question today. I know there's been a huge amount of focus on kind of the first few weeks of Foundeo and specifically kind of the launch strategy and activation of the different channels. Perhaps, Ken, it would be helpful if you could talk through how does this compare to kind of a traditional primary care launch? What things are you accelerating? what things are you holding back and for what reasons, particularly in the context of the fact that you've got extreme amounts of inventory pre-prepared for the launch of this product.

Executive Name (Title): Okay. Thanks, Courtney. Ilya, do you want to make a few more comments about the Foundeo launch vis-a-vis primary care?

Executive (Title): Sure. Yeah, maybe just probably the three elements I discussed earlier are probably the same for all of our primary care launches, where you need to grow the prescriber base and understanding of the profile of the medicine and that's what we're doing here with foundeo building out access and quite frankly this is actually getting access very early in launch both on the commercial side having two of the three being activated in the next couple of weeks and getting part d which is usually usually lags in july is a faster ramp on access and so we're excited about that aspect The piece that is probably on the primary care side an important element that many have noted is around DTC. And we activated from day one in the first week a number of both digital, social media, and out-of-home advertising on the brand itself. But it does take time to build out consumer awareness. understanding and awareness of the brand. The current sentiment, if you follow the total number of impressions and what consumers are saying about the profile foundale, is resonating. So both the efficacy as well as the overall profile on not having food or water restrictions.

And so that element is positive. Now, obviously, having full DTC launch, we're still activating that probably earlier than normal because there is familiarity around GLP-1. But we do want to take a moment and be disciplined in the approach of making sure that we build that awareness and understanding before we go full throttle.

Quarter 2

Q4 2025 Earnings Call — February 4, 2026

Management: Thanks, Dave. We'd like to take questions from as many callers as possible. So consistent with prior orders, we will respond to one question per caller, and then the call promptly at 11. If you have more than one question, you can re-enter the queue, and we will get your question in the house. Paul, please provide the instructions for the Q&A session, and then we are ready for the first caller. Thank you.

Management:

At this time, we'll be conducting a question and answer session.

If you have any questions, please press star 1 on your phone

at this time.

We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star 1 at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions.

Management: And the first question today is coming from Evan Siegerman from BMO Capital Markets. Evan, your line is live.

Evan Siegerman (BMO Capital Markets): Hi, guys. Thank you so much for taking my question. Congratulations. So a year from now on this call, I'd love for you to characterize what you would ask for for good front launch. Specifically, what are some of the metrics that you're looking to meet? I know you're not going to give guidance, but some qualitative kind of commentary would be most helpful. Thank you.

Ken (Executive): Great. Thanks for the question, Evan. It cut out a little bit, but I think you were just asking about a year from now, what are some things we'll be tracking on for Orfaglipron? So I think for that question, maybe we'll go to Ken to maybe talk about some things that we'll be looking at. Sure. Thanks for the question about Orfaglipron. We're really excited to have this medicine submitted, not just in the U.S., but now 40 countries, and looking forward to launches beginning this year. As I think about success factors for us going forward maybe towards the end of the year, we'll be looking at a few things, first of which is market expansion. We're very encouraged by what we're seeing with Oral-A-Govi as it validates our belief that there's a substantial number of people with overweight and obesity who've been sitting on the sidelines waiting for an oral option. It looks like these are mostly new starts. That means it's expanding the market, and that's good news for Lilly. We feel really good about the competitiveness of our profile. We've talked about that a lot on previous calls.

I think we're at the point now where we're going to pivot to how do the world results play out. We think this is going to be about patient satisfaction. And our profile, which is simple with no restrictions on food and water intake, could make a big difference in the real world. So we're excited to get off to the races here, see this market expand, and really look at overall patient satisfaction scores and real-world efficacy with these agents. Thanks.

Management: Great. Thank you, Ken. Paul, ready for the next question?

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

Courtney Breen (Bernstein): Hi, everyone. Thanks so much for taking the question today. Just building on the question around the offer, you mentioned that you have submitted in 40 countries. Traditionally, you tend to think about kind of a full year cycle for most approvals in many countries around the world. Can you just help us understand if you're anticipating any kind of accelerated pathways that you might be able to access in these ex-U.S. countries that would enable launch in 2026 for Orfaglipron similar to some of the pathways that are available in the U.S. and you've been able to garner one of them. Thank you so much.

Patrick (Executive): Great. Thanks, Courtney. And so for the question about how we're thinking about OUS approval timelines, we'll go to Patrick. Thank you very much, Courtney. As I think we shared in the prepared remarks, outside of the U.S., it's mainly going to be a matter of launching the first half of 2027. There will be a few markets late 2026, and a few exceptions for countries like, for example, the UAE, but might reference an FDA-approved of Oglepron. So mainly a play late 2026 for the international markets.

Management: Great. Thank you, Patrick. Next caller, please.

Management: The next question will be from Chris Schott from JP Morgan. Chris, your line is live.

Chris Schott (JP Morgan): Great. Thanks so much for the question and congrats on all the progress here. Can I just ask about International Manjaro? This seemed like this was a very significant upside driver, at least relative to street numbers in 2025. And I'm just interested in your thoughts on the ramp from here as we think about the 3.3 billion 4Q result just reported. I know last year was about a lot of new market launches. Now you're in those markets. How do we think about kind of sequential growth from these levels? Thank you.

Patrick (Executive): Great. Thank you, Chris. For the question on OUS Monjaro performance and the ramp from here, we'll go back to Patrick. Thank you very much, Chris. Well, you are right. Q4 was a very strong quarter for Monjaro also outside the U.S. And as Lucas referred to, we became a shadow market leader for total incretins also internationally. When you look at 2026, I would just reflect back on 25 where major launches more or less every quarter with the exception of Q4. So I would actually look at Q4 as a base for the 2026 growth, but also consider that there was a slight impact in Q4 driven by the NRDL listing in China, effective 1-1-2026, which slightly impacts the purchasing pattern in China in December. So see Q4 as a base for 2026. Moving forward, our business now over the U.S. is 75% chronic weight management, and that's pretty much out of pocket. 25% is reimbursed for type 2 diabetes. So the priorities for 2026 will pretty much be market expansion, driving more penetration through patient activation when it comes to chronic weight management. And for type 2, we are leaning in to gain reimbursement in more countries. We are currently reimbursed in nine, with the last one being China with the NRDL. And we will do that with a maintained discipline in terms of pricing. So I think overall, we are well positioned for a continued growth for Monjaro outside the U.S. in 2026.

Management: Thanks, Patrick. Patrick, next question, please, Paul.

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

Seamus Fernandez (Guggenheim): Great. Thanks so much for the question. So I'm actually going to ask a non-obesity question. So while you can't take your eye off the ball on obesity, just wondering why you couldn't attack immunology broadly in the same way as you have obesity, investing earlier, faster, and more aggressively given the substantial cash generation that we're starting to see from the overall portfolio, what are the issues that would prevent you from doing something like this, whether it be by your internal efforts or perhaps a more aggressive business development approach, just because it seems like this is a sort of cash-driven opportunity where there's a lot of spend, but a huge amount of upside opportunity with $170 billion of total market out there to access.

Dan (Executive): Great. Thanks, Shamus, and extra credit for the non-obesity question. We'll go to Dan to talk about our approaches on attacking immunology early. Thanks, Shamus. It's a great question. Actually, I'll come to immunology in a second, but let me just first point out that across our non-obesity work, which is, of course, oncology, neuroscience, and immunology, we have our thumb on the scale for investment decisions. We see lots of good opportunities in those areas, and we're reinvesting some of the proceeds from the obesity opportunity to make sure we can further accelerate growth in those promising areas. Today, you heard me talk a lot about the oncology portfolio, which I think is really blossoming right now. I have high hopes for immunology behind it. I think there's really promising breaking science, including treating immunologic diseases earlier, and our research labs are doing everything in our power to harness that science. Today, I talked a little bit about some trials that are ongoing for incretins in immunology, which I think is promising, as are a number of other combination therapies that we now have in our late-stage clinical trials. So I'm excited both early and late about what we can do with immunology.

Management: Great. Thank you, Dan. Next caller, Paul.

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

Terrence Flynn (Morgan Stanley): Great. Congrats on the quarter. I had a question on the guidance high level, Lucas, just wondering if you can talk about what's embedded for Medicare volume ramp in the back half of the year and how that might drive the range we're seeing on the revenue side. And then if that's had any impact on employer opt-ins on the commercial side. I know you guys previously talked about how that might have some impact to get some of the other employers over the hurdle on coverage. So just wondering if you're starting to see that yet.

Lucas (Executive): Thanks, Terrence, for the question on guidance and kind of Medicare ramp in the back half of the year, as well as if there's any commercial opt-in. We'll go to Lucas. Yeah, Terrence, thank you for the question. Maybe starting with Medicare, as highlighted in the call text, basically, we are expecting that access to be granted no later than July 1st. And as I mentioned all along, this will take time to build over time, but we feel very, very positive about the opportunity to bring anti-obesity medications to patients in Medicare. As I mentioned, again, the co-pay of $50 for the patients would be a compelling value proposition as well. There is a volus of patients that we have nowadays in the direct business that we believe are also Medicare patients. We expect that bolus, I think it's between 10 to 20%, will actually move into the Medicare space. I think that will happen relatively fast, and we will continue to build on top of that. So that's kind of the driver start to think about, again, the penetration, but we'll build over time. We think about, again, more about the size of the opportunity in Medicare, thinking about 2027 as well.

The second part of your question was about the employer opt-in. I have Ilya right next to me here as well to talk about it. But as all along you said, of course, again, the practice on physicians prescribing this medicine will become more natural, more broader in the anti-obesity medications. And physicians will be, again, more broadly basically also thinking about prescribing this in commercial. How that will then impact the employer side, I think the message is clear, right? Again, there is a clear recognition of the class as a chronic disease. and basically that will, in my eyes, will propel also employers also to think about, again, this class and also employees to look for this class of medicines as well to be covered as well. But I don't know if it's anything else that you would like to add, Ilya.

Ilya (Executive): Yeah, maybe just some additional context, Terrence, on commercial opt-in. Obviously, we start the year roughly on balance, relatively stable. There are some employers adding coverage, some removing some coverage, but we're putting additional focus in the employer space. We've stood up a team and also working with a number of third parties to actually provide alternative access channels to have some flexibility in design, transparency in the pricing, and the initial conversations and feedback has been positive. Of course, a lot of those decisions are for the following year. We anticipate having some of those decisions and increased coverage over time in the employer space as we head into the back end of this year and mostly into 2027.

Management: Great. Thanks, Lucas and Ilya. Next question, please, Paul.

Management: The next question will be from Jeff Meacham from Citi. Jeff, your line is live.

Jeff Meacham (Citi): Great morning, everyone. Thanks for the question. Congrats on the quarter. Dan, I have one for you. The together results are really super interesting. How are you thinking about the potential for combo therapies with ZEB bound and either INI or oncology or neuro? I wasn't sure, you know, what drives the investment priorities, whether it's the drug or the indication, and if there's a clear path to a labeling claim. Thank you.

Dan (Executive): Yeah, thanks, Jeff. Again, another non-obesity question, so lots of extra credit on this call. We'll go to Adrian to talk about some of the combination therapy approaches and some of the strategies there. Sure. We see this as a significant opportunity. Obviously, you know, more than a billion people worldwide have immune diseases like atopic dermatitis, psoriasis, IBD, and asthma. But patients who have both immune diseases and obesity tend to have a higher disease burden. So we're really excited about the opportunity to find new ways to combat the underlying inflammation of these diseases and potentially unlock better, longer-lasting results for these patients. So we have, you know, broad efforts underway to look at additional combinations. We have the TOGETHER PSO trial evaluating the use of TALT and ZetBound for adults with moderate to severe plaque psoriasis and obesity or overweight. We expect those top line results in the first half of 2026. We're also looking at the TOGETHER Amplify PSA and TOGETHER Amplify PSO studies assessing the effectiveness of adding ZetBound after starting TALT for adults with PSA and moderate to severe plaque psoriasis.

We also have the Phase 3b COMMIT studies in both ulcerative colitis as well as Crohn's disease, where we're looking at the concomitant use of Omebo and Zepbound in addressing outcomes for those patients, and then the Phase 2 study of Brenipatib for people living with uncontrolled asthma. So we're excited to continue to pursue the applications of Incretins and unlocking better outcomes for people with immune diseases.

Management: Great. Thanks, Adrienne. Thanks for the question. Next caller, Paul.

Management: The next question will be from Asad Haider from Goldman Sachs. Asad, your line is live.

Asad Haider (Goldman Sachs): Great. Thanks for taking the question and congrats on all the progress. Back to obesity with apologies, Mike. Maybe just given the focus on pricing dynamics, can you just talk about what you're seeing in the contracting environment, broadly speaking, across the infinite portfolio? And also, what's your view on price elasticity in the cash channel as the year progresses? Thank you.

Ilya (Executive): Asad, thanks for the question. To go through pricing in the U.S. and price elasticity, we'll go to Ilya. Sure. Thanks for the question. Maybe just for the first part in terms of the commercial access and contracting, obviously, we start the year with similar coverage as we ended 2025. We continue to have coverage for ZEP bound in two of the three large PBMs. We continue the conversations around expanding access in those PBMs for obviously the introduction of Orphaglipron in Q2, so we're in active discussions there. From a pricing standpoint, we've been pretty transparent on pricing for 2026 as it relates to Part D, as well as our direct-to-patient pricing, which we implemented at the end of December. And then we have ongoing conversations with improving and continuing access in the commercial segment.

In terms of price elasticity, we've seen over time, both in the U.S. and outside of the U.S., that affordability and opportunity on the entry, as well as predictability of cost for patients matter. That's why the out-of-pocket in Part D of $50 is an affordable option, as well as we've seen an increase in utilization of even ZepBound Vial at the end of the year when we implemented improved entry price of $2.99 for ZepBound. So we continue to see that, and obviously we're seeing significant and encouraging uptake in the oral market, which is expansive, and bringing new patients to obesity treatment. And we're excited to launch Rofroglipron soon with the entry price being similar to oral semen.

Management: Great. Thank you, Ilya. Ready for the next question, please, Paul.

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

Mohit Pansal (Wells Fargo): Great. Thank you very much for taking my question. So a strategic one. So I would love to understand what is your latest thinking on the importance of getting obesity-related indications on the label? Because we kind of get the mixed message, a little bit of mixed message when we talk to payers because they kind of think that these drugs are just for obesity for now. With NASH, they're still covering for obesity with NASH. But do you think this could be an overtime long-term differentiator here now that you are going into indications like INI as well at this point? Thank you.

Ilya (Executive): Thanks for the question, Mohit. So to kind of think about and address our strategy on obesity and expansion of indications more broadly. We'll go to Ilya to go, and then, Ken, you can add if you have any other development thoughts. Sure. Thanks, Mohi, for the question. You know, what we've seen thus far, even with ZEPP-bound and looking at Medicare population around sleep apnea, we're seeing an increase in utilization and thinking about obesity beyond weight and looking at outcomes related to obesity and a lot of comorbidities, as Dan had mentioned, even in our psoriatic arthritis trial with Pulse. When we talk to employers as well as payers, they think about the multiple aspects of obesity and what that means for coverage and cost long-term. So we do see a growing body of evidence to support covering obesity medications for population and having a positive impact to public health beyond just weight. So thanks for the question on other potential avenues of exploration as it relates to complications and comorbidities.

You know, as our Incretin portfolio and amylin portfolio expands, we're always facing the question of do we spend our resources replicating findings from previous anchortins on comorbidities and complications where we know these drugs are efficacious, or do we push into new areas and generate new evidence? You've probably seen with orthoglipron, we're actually starting to explore new ideas like stress urinary incontinence, peripheral artery disease, and hypertension. We'll continue to look for new push anchortins in addition to what we've talked about in the INI space. But we do also understand that with new molecules and new mechanisms, it's important to generate some data to continue to give prescribers and patients confidence that these medicines preserve the benefits of the previous class of medicine. So we continue to do that, too, but very pleased, I think, with our overall balance of investment across the Incur10 portfolio in both sort of established and emerging mechanisms of diseases of interest.

Management: Great. Thank you both. Ready for the next question, please, Paul.

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

Umair Rafat (Evercore): Thank you, guys. Cash pay I feel like has been a very important driver of growth among other drivers. And I'm just trying to think out loud what the long-term implications of that could look like, especially with all the competition coming. On the one side, obviously, there's going to be tremendous brand loyalty, which is very important in cash pay. But on the other side, the traditional PBM contracts and rebate wall may not apply. So I'm just trying to think out loud how you're thinking about share retention and cash pay in the long run. Thank you.

Ilya (Executive): Thanks for the question, Umar. To discuss a bit about sort of the cash pay dynamics, I'll ask actually Ilya and Patrick to discuss how it plays out internationally and as well in the U.S. So Patrick, you want to start first? You know, I think what we have been building over the last couple of years, learning a lot from the U.S., has really been the consumer centricity. And I think it's a matter of building platforms along the lines as we have done in the U.S. with Lilly Direct, where we are providing the opportunity for patients both to seek, start, and to stay. So I think that's a massive that we need to continue to develop.

Patrick (Executive): Yeah, just to add on, I think we've learned quite a bit. There are frictions in the system for a number of diseases in the U.S., and globally, obviously, we've seen that happen in obesity areas. What we've built within Lilly Direct as a pretty significant scaled direct-to-consumer platform that helps address some of the frictions. Of course, we can continue to think about how we evolve that consumer experience and make this more seamless. At the same time, growing access across the different segments. And so both will play an important role. And we continue to look for ways for us to scale as well as improve on the experience over time.

Management: Great. Thanks both for the comments. Let's go to the next question, please, Paul.

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

Alex Hammond (Wolf Research): Hey, guys. Thanks for taking the question. One on Allura-LinTide. So the weight loss results you guys presented last year look really strong. But given prescribers and patients seem more interested in more favorable tolerability, how should we think about the potential for lower doses of Allura and lower dose combos with Prezepatide to potentially achieve a titration-free placebo-like tolerability with weight loss, let's say, comparable to monotherapy GLP-1? Thank you.

Ken (Executive): Thanks for the question, Alex, on Allura-LinTide and future avenues there. We were really excited about the data we shared at Obesity last week, where patients achieved up to 20.1% weight loss for the loralentide, with excellent tolerability that was improved with titration. In fact, in the 3, 6, 9 milligram titration group, I think we only had one incidence of vomiting out of more than 50 patients. So that compares, we think, really favorable versus the existing incretin class. So we see a big opportunity for a loralentide in patients who maybe just can't tolerate Incretin, we know that 5% to 10% of patients in our trials tend to discontinue on the incretin class, suggesting a pretty big opening given the size of the Bucity market. Of course, we're also interested in thinking about oligolentide in combination with other mechanisms of action and what you alluded to with GIP plus GLP-1 plus amylin. It's a very sort of physiological construct, three nutrient-stimulated hormones. And we've shared that we are exploring that idea in the clinic, nothing to share yet, but stay tuned maybe towards the end of this year. We're testing other possible combinations, including a GIP agonist macupatide, glucolyntide as well. And so really just trying to understand the range of options. And like you said, is there really an optimal, very simple permutation of mechanisms that could allow minimal or no titration with competitive efficacy?

Management: Thank you, Ken. Paul, ready for the next question, please.

Management: The next question will be from James Shin from Deutsche Bank. James, your line is live.

James Shin (Deutsche Bank): Thanks, guys. Hey, good morning. One for David. For CMS's upcoming obesity demonstration, David, can you share any similarities or differences you foresee from what you went through previously during the Part D senior savings model for insulin's $35 copay rollout? Thank you.

David (Executive): Great. Thanks, James. And I will welcome Dave to get in the box for the Q&A. Okay. Can you share any similarities on the CMS obesity pilot versus the Part D senior savings? Yeah, I mean, I think there are quite a number of analogies to draw. I mean, first, arriving at what would be perceived as a relatively low out-of-pocket is an important fact by itself. And while we know in this case we're not moving from high out-of-pocket to low, only moving from covered plus low out-of-pocket. And I think patients who may be using GLP-1, and the data we have is that seniors are using these drugs at a lower rate than the general population, maybe because income in particular will benefit from that lower cost every month of $50.

I think that's very expansionary to the class, and will draw a lot of interest from primary care prescribers who are concerned about the comorbidities of kind of lifetime overweight and obesity, which tend to manifest after 65 at a much higher rate. The second thing is the consistent experience, and I think when we negotiated this with the government, we wanted to make sure that we weren't just building a program that went into the normal Part D math in terms of out-of-pocket costs, but had kind of that consistency. Independent of the absolute amount people pay, they get very frustrated with different amounts month to month. So I think that's another important feature. Thirdly, like the insulin deal, it's open to all innovators. And I think that's an important concept that the doctor and the patient choose the best therapies, which could be one from us, one from our competitor. It could be oral. It could be injectable. It could include future therapies from Lilly or others, like ritatratide or aloralintide when they're approved. So I think that also has a parallel to what we did with insulin.

If you look back at that insulin pilot, utilization rates increased pretty dramatically in Part D, and frustration levels with that issue basically disappeared. I think this program has a similar promise to be both enormously popular, drive a lot of new uptake. As I said, it's suppressed in the senior population who could probably benefit most, at least in the short term, from GLP-1 therapy. And I believe, and I know that CMS does as well, that within a few years will demonstrate significant cost savings to the Medicare program. So that is different than the insulin part, but that's associated with new products being added. So we're excited to get going. We expect this to be effective by July 1. Working through the details with the administration now, and you'll hear more maybe on our Q1 call.

Management: Thank you, Dave. Ready for the next question, please, Paul.

Management: The next question will be from Steve Scala from TD Count. Steve, your line is live.

Steve Scala (TD Count): Thank you so much. 2026 revenue guidance is $15 to $20 billion higher than that delivered in 2025. Munjaro and Zepp-Allen are doing great, but we can kind of see their trajectory. Are there scenarios where these incremental sales can be delivered without Orfaglipron being a $5 billion product in 2026? And does the guidance tell us that Lilly believes orals will grow the market and not cannibalize? Thank you.

Lucas (Executive): Great. Thanks, Steve, for the great questions as always. We'll go to Lucas to talk a bit about the revenue guide and some of the moving parts that are contained within that. Yeah, thank you for the question, Steve. Thinking about the guide, again, you can do the math on that perspective, but when we think about the process, maybe start from there, as always, we do a bottom-up approach on what we see in the marketplace and then across all the therapeutic areas and geographies as well. And we have, again, a point of the guide as kind of what is our goal for the year to start with. There are many multiples pushes and pulls, and I described that during the call text as well, talking about, again, the expansion in Medicare that Dave just covered, talking about the launch of Orphoglipron as well, and a continuation of growth that we expect to see both in the U.S. and our U.S. markets. I think it's fair to go back as well about the basically the price component as well, that is embedded into the guide as well. That's another component that is going to be actually accelerated in 2026, that erosion versus 2025. And I call out basically low to mid teens.

That's a new component to basically some of the math that you were thinking about 2025 that you need to factor as when you're doing those forecasting and models that you described. In terms of your Foglipron question, I think it's important to highlight looking at even just the last four weeks of the data of the competitor launch is mainly expansion of the market. So we are very, very encouraged from, again, the first month of seeing that data, and it's very much consistent with our expectations and our guide. We will see how much, again, that class will continue to grow over the years, and we will update our guide throughout the year depending on that.

Management: Great. Thanks, Lucas. We have time for a couple quick ones, so if we could do the next question, please, Paul.

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

Akash Tiwari (Jefferies): Hey, thanks so much. So, Dave, you've mentioned that investors who really understand Lilly recognize it's a consumer stock. Can you talk about some consumer analogs you'd point investors towards when you're thinking about long-term penetration for both the U.S. and ex-U.S. for your weight loss product? And then maybe just on the cannibalization point – Is it fair to say your guide isn't expecting meaningful cannibalization of the oral and injectable obesity products versus what we've seen with Novo? Thank you.

Dave (Executive): Definitely a few part of there, Akash. So we'll get Dave to talk about more analogs. Well, I think Lucas has covered the cannibalization, but it's not what we're seeing right now, nor is it what we really expect. In a way, though, just strategically, it doesn't really matter to us. I think we're interested in having people on the medicine that they think and their doctor think is best for them. And if it comes from Millie, that's our goal. So we're not too concerned about that. But I don't actually expect a ton of cannibalization, to be honest. In terms of consumer analogs, it's a difficult question. I'd be open to your feedback on this. We spent a lot of time modeling out the trajectory of the out-of-pocket business. Patrick and Ilya commented on that. I think at the J.P. Morgan conference, I spoke about this. I think it is a bit of a wild card in our short and medium term.