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

Day 1. We're thrilled today to -- my name is Geoff Meacham. I'm the senior biopharma analyst, and my team is in the audience as well. So we're thrilled today to have Ilya Yuffa, who is EVP and President, Lilly USA and Global Customer Capabilities.

That's right.

So that's a bit of a mouthful.

Yes, I know.

Let's talk a little bit of maybe just your prior role at international, like kind of how that's evolved and then we get into some specific questions on incretins, I'm sure.

Sure. Well, good morning. Great to be here with everyone here. Obviously, last number of years, we've had a lot of progress across our portfolio. Last almost four years, I was Head of International, leading all the markets outside of the U.S. And our focus has been around -- I know lot of patience around the -- around supply and making sure that we can actually launch in so many markets. And we're seeing that success come through in many markets outside the U.S. over the last number of quarters, gaining traction, a lot of different -- a lot of new launches in many new markets. And that's been an important element. A good portion of that has come through for obesity and self-pay, and we've learned a lot on self-pay, both in the U.S. and outside the U.S. And around 6 months ago, I transitioned to be Head of the U.S. and still own a lot of our kind of customer consumer capabilities, think like LillyDirect as being one key component of that, and how do we expand LillyDirect beyond the current scope.

I guess, Ilya, the first, maybe a more topical question is you guys have had a recent agreement with the White House. We had Dave on the road a few weeks ago talking about the details of that. Orforglipron is a big component of that as you look forward to kind of next year. Talk a little bit about where -- how you would rank your priorities looking to 2026 from a commercial perspective.

Sure. Well, first, I think we've been in a -- in the last couple of years and obviously, this year, we've expanded the focus related to obesity being treated as a chronic disease. And we've made a lot of [Audio gap] We anticipate that being sometime early Q2. And the third is continue to innovate related both in terms of our pipeline, but also in terms of our consumer offering and capabilities there. We've done quite a bit on LillyDirect and have had some great success, close to 45% of new starts are happening through LillyDirect or our vial single-dose vial option. We've announced recently a partnership with Walmart to have of another option for patients from a convenience standpoint on how to pick up their prescription. We've also announced components of direct-to-employer elements as well. So expanding and offering and being able to have more people gaining access to care and obesity is going to be a significant focus in 2026.

I guess in the question -- the follow-up question, Ilya, would be like how do you segment the tirzepatide kind of commercial in the U.S. with broader access to the orforglipron launch? How would you sort of view those two together.

Sure. I think in several different components. The first piece is that Zepbound already is becoming a standard of care and great preference towards Zepbound in the setting. Obviously, as you expand greater coverage through Medicare as well as over time through Medicaid as well as commercial, you'll see greater opportunity for Zepbound in many patients that prefer a dual agonist for efficacy and overall tolerability, where I saw orforglipron playing a significant role is that you see many patients that -- and providers that are looking for options for that initiation to their journey in obesity. And so having another option that may provide great efficacy that may not need the same level of efficacy as a dual agonist is a significant option so that entry and those that there -- we've seen many providers as well as many people not ready for an injectable therapy. And so we see an oral strong efficacious or option being a great entry point. And then obviously, we're still leading our results for sustained maintain, where you see a transition of people going on in being on injectable therapy, whether it's on a single agonist or dual agonist and then transitioning over to orforglipron and seeing whether or not they can maintain their goal. And that could be also a significant option to expand the overall number of people that can benefit from obesity treatment.

Let's focus on that for just a second. So if you look in the next few years at orforglipron, let's call it, in the U.S., would you expect most patients to be on as a maintenance therapy? Like how do you balance kind of the new starts that are more overweight not obese, that are sort of new to the category versus those in the maintenance setting? Like is it 50-50? Is it bias, not asking for guidance.

Yes, I think what's probably best to predict is that all of our forecasts are typically wrong, okay, meaning that we're still early in the obesity category overall and a number of people being treated currently. So the penetration rate is still in single digits. And so there's probably two components of significant opportunity. And I think that holds true for both orforglipron as well as for Zepbound is that as you expand coverage, you increase the number of people that would have access to care beyond the self-pay component. And so that is going to increase both injectable and opportunity for orforglipron or oral therapy. The other component is that you should see an increase in overall market and people entering treatment by having more options and having an oral option, a simple oral option is a great component, where you'll see an increased utilization of that entry point with oral. So I do see orals over time as you expand access, having a greater proportion of entry. And over time, I think what we've heard from providers from payers, from patients is understanding that this is a chronic disease. Once they get to the point where they're at their target weight or health goals, what options are there for maintenance. And I do think having an oral maintenance therapy would be a great component for increased utilization for those patients. But again, many that have -- were able to achieve their target goals on an injectable therapy may decide that they want to stay on injectable therapy. So it's hard to predict the exact proportion. I see both markets for oral as well as injectable incretins being significant size. And obviously, we've already had a few years on the market, where we've had the ramp in overall utilization for Zepbound, it will take time to have that same work out for orforglipron, but I'm pretty optimistic of that especially as you increase overall access and the deal with the White House related to Medicare and over time, Medicaid significantly increases the number of people that would be eligible for treatment.

Let's talk about that for a second. So Medicare is April 1, Medicaid, mostly over the course of next year. Talk about the sort of the pace of some of these payer segments and maybe as they fully roll out. And obviously, we haven't talked commercial, but that could be a component that sort of overlays all.

Yes. I can talk through each -- probably four segments that are worth discussing. And probably if you think about 2026, they're probably wider error bars than normal because of pretty significant assumptions overall. So you have Medicare that could start as early as April 1, but it could extend to July 1. So it's in that window. And what's important to note there is that what we've negotiated is a pretty broad access. So that 80% of on-label population would be covered through a pretty frictionless component of a prior authorization and a relatively low out of pocket of $50 per month. So that's an important aspect as part of the Medicare piece. And obviously, it's not a flip of the switch that everyone who's eligible will start day 1. And so that ramp will happen gradually over time. Medicaid, most states have already decided in their budgets for 2026. And so while we're in discussions currently with a number of states, that will take probably a longer period of time to incorporate incremental access on Medicaid. So I think you may have some improvement in 2026, but think 2027 for Medicaid to gradually increase. And then what we've also committed to as part of the agreement is improved price offering in the direct-to-consumer segment, which we actually announced yesterday to advance by 1 month, the -- our direct-to-consumer pricing. For Zepbound, so a lower initiation for the 2.5 milligram at $299, progressing to $399 for the 5-milligram and $449, so roughly $50 decrease for month's doses for the direct-to-consumer offering. And so that should increase the number of people that will enter through self-pay. And then the key component that we continue to work on that will be gradual in nature. And of course, we have this every year is pressure on the commercial pricing that we have all the time. So I anticipate that continuing. And the key there is to increase the employer opt-in. And so we're actively looking at how do we increase and improve kind of -- if you think about the lowest friction, which is on the self-pay actually, in terms of prior authorization, if someone is eligible, they can go directly on self-pay, but obviously, that comes at a cost to what we've negotiated in Medicare, which is the other spectrum of a low out-of-pocket covering about 80%. And then the commercial, which create -- which has kind of greatest variability in the friction. And our goal is to increase employer opt-in over time. And obviously, that's our focus, and that will happen gradually. And to the extent that will happen in 2026, we will continue to work hard on that piece and expect that as you improve access and eligibility in other segments like Medicare and Medicaid, that puts incremental pressure on employers to have that offering for employees as well as the incremental data multiple, not just on tirzepatide, but also for orforglipron and obviously, the introduction of orforglipron and the timing of that. Also, obviously, we have the voucher, but that's a new program and understanding exactly when orforglipron will be approved is an important element in that dynamic, but we anticipate early Q2 launch. So a number of different variables in the different segments. And the key is to expand access across all segments in the next couple of years. The government deal, while we took pricing as a concession, immediately, we believe that the acceleration of access by a few years is worth it.

Right. And to what degree is Lilly Direct a central component of broader access. Maybe talk a little bit about how that's evolved over time, and how the lessons learned on things like elasticity and -- kind of from a demand context?

Yes, it's interesting. When we first experimented with LillyDirect, it was meant to -- actually it was our backstop on ensuring transparency on insulin pricing and ensuring that patients can actually get insulin at our commitment on $35 out of pocket. And when we launched Zepbound vial in LillyDirect, what we learned to a great extent is the significant unmet need with people with overweight and obesity, where there's a lot of friction in the health care system. And where LillyDirect plays a significant role is, first, it allows for complete transparency on pricing and what to expect if prescribed treatment for obesity. That's one key component that we've learned. The second is around providing access to information and disease education and a way to talk to whether it's a telehealth physician or making appointment with a live physician having it go through one system and being able to fulfill on the back end to a patient at their home was a significant component as well. And so we've learned a lot about what patient preferences are related to -- and the frictions that exist in the system. And so LillyDirect is a key component in ensuring a frictionless or smooth process for a patient in their journey with obesity. From a price elasticity standpoint, I mean anytime you launch any new pricing, you learn a little bit more about what a patient experiences, both at entry and maintaining therapy. What we've seen on maintenance of therapy and adherence to therapy in self-pay on kind of before we even modified the pricing to what we announced yesterday is that many patients get a great experience on Zepbound even in self-pay and the adherence rates are not that different to what we see in the covered lives. And so that's an important element in understanding price elasticity. There is a component of the profile of the medicine plays a key role as well on what benefits can be provided as part of the overall package on pricing as well as the overall experience. So bottom line is that LillyDirect regardless of how broad the access and coverage becomes a key component will still play a pivotal role in ensuring transparency and smooth experience for patients as they navigate their journey. And as we broaden out other therapies into LillyDirect, obviously, the plan is for orforglipron to become a component of that as well. And in years to come, we have a lot of progress in our pipeline as it relates to obesity.

And I know in your prior role in international, you looked a lot about the country by country and the kind of role out. Talk a little bit in the context of the White House agreement and MSN, talk a little bit about the pricing disparities and kind of volume versus price kind of trade-offs as you look more broadly outside the U.S.

Sure. I think there are different components and different therapeutic areas that are probably impacted with greater variability. So if you think about medicines in the primary care setting, the variability in pricing, OUS and the U.S. is probably in a tighter range. And so I don't see a significant impact. There is an impact that adds a significant impact in the primary care setting. Having said that, the deal with the White House regarding MFN, what we negotiated directly on pricing for incretins and for Zepbound and orforglipron, that is the pricing we incorporated, so that exists outside of the MFN component. Probably -- obviously, we made commitments around MFN related to existing portfolio in Medicaid. And so you'll have some impact in medicines like Taltz, Verzenio. So that will have a more significant impact for Medicaid. And then on a -- from a forward-going basis, the commitment on launching new medicines outside of incretin in the U.S. were tied to MFN to the G7 plus Denmark and Switzerland and taking out the lowest one. And those do have an impact on the calculus for medicines that have probably greater variability on gaining reimbursement in markets outside the U.S. I think the key component there is continue to think about policy in OUS markets in making sure that there's value seen in our innovation. And so how do we increase the value of innovation for our medicines in those categories. But those are probably the most challenged. If you look at immunology, oncology, in particular. The others, I think, are in a tighter window, and we'll continue to evaluate how we market those outside the U.S. They're contained in those markets. At the same time, our mission is to improve global health and improve human health for the medicines and the therapeutic areas that we play in. And so we'll actively look on how we actually do that. But to your point, the dynamics between the U.S. and OUS are probably front and center in our negotiations for reimbursement and access in OUS markets.

So the White House agreement, at least for incretins could be a good model for OUS kind of price involving generally speaking?

Yes, I think that's what we've negotiated there and the differential what we see between Zepbound and orforglipron would probably expect something similar outside the U.S.

And talk a little bit about the compounding risk. I mean, I think in the early launch of tirzepatide, that was a bigger deal, and it's affected Novo more than you guys. But to what degree do you think that still remains kind of a lingering issue as you're -- before you really see this pretty profound rollout, right, from volume perspective?

Sure. Well, listen, the first and foremost, illegal compounding is a significant issue primarily from a public health standpoint. And then we get a lot of reports from patients and providers on fraudulent and pretty concerning facts related to illegal compounding and what's in the market. And so it's a significant health concern. There are several aspects that I think are important to address. I think the first is we're doing what we can from finding this from a legal standpoint and there are a number of cases that we've won, but that's one effort. The second, which is the FDA needs to play their role in increasing their enforcement in a legal compounding. And the third element is broadening out access to authentic medicine is a key component for us to broaden out that coverage. We're not as impacted in the way that we evaluate and forecast demand compounding to our overall revenue and demand for Zepbound and for the future orforglipron. At the same time, increasing access and increasing activation of patients through LillyDirect is a key component for us to combat this.

So if you look at the GLP-1 and sort of the evolution of the indications we start off with diabetes and now have obesity, and you guys have expanded into alcohol use disorder and related indications like stress urinary incontinence. So how would you prioritize maybe related indications for GLP-1s into things like neuro psych or inflammation. And then maybe what's the selection process with the assets that you have, like which ones are going to be more aptly suited?

Yes. Maybe -- a couple of different components there. So maybe first, we're looking at three different broad areas. The first one, which is cardiometabolic health. That's a key component where we know more about the mechanism and efficacy, and what we should expect there and all of the adjacencies related to comorbidities within obesity, that's a significant priority, and the way that we think about that is whether it's sleep apnea or looking at other related comorbidities, increasing the body of evidence on where Zepbound, orforglipron or other incretins can work in obesity helps on improving access. So widening the the ability to gain access with payers, both U.S. and OUS. It also creates with providers and with patients, a sense of urgency to do something beyond weight. And that is also a key component of ensuring that we're focusing on improving health as it relates to obesity. So that's one key component of driving evidence in all of the adjacencies related to obesity care to widen access, and how you think about the sense of urgency to actually treat. So it should increase the penetration in the overall market within obesity. The other two pieces are around probably inflammation and kind of brain health. And those are probably some higher risk areas for us to study. Obviously, we're looking at tirzepatide, and how it can work with maybe Taltz or Omvoh and whether or not it can amplify effect in inflammatory diseases. We're looking at asthma with brenipatide, so whether or not that can be a component of incremental areas where we can improve health. And then obviously, we're looking at brain health in relation to whether it's depression disorder or aspects like alcohol user substance abuse where there really aren't many options there and many people that are even diagnosed typically don't have access to any viable treatment. And so that's an opportunity for us to make a real difference in human health. So the way I would prioritize it is obviously the big bucket of where we need to expand overall access and utilization in obesity. And then based off of the science, go after opportunities where we can improve human health in other areas outside of obesity like inflammation in neuro diseases.

Yes. And then on the brain health component, I know we just had the EVOKE studies from semaglutide. I don't think that was much of a surprise to anyone. But talk about kind of the next steps for Lilly. How do you maybe process that and kind of think about growth opportunities beyond.

Sure. Well, I think Alzheimer's in general in dementia is an important aspect of human health that we need to still do a lot of work towards. We've had three decades worth of work in Alzheimer's. And after each study and failure, you learn a lot, and you iterate, and you incorporate that learning back into new science and innovation. And so we've actually -- we have that with Kisunla now, and we're to learn more about Kisunla and looking at preclinical. And obviously, the EVOKE, we need to study once we get all of the readout from EVOKE to understand that and the implication there and whether or not there's something for us to pursue. We're committed to Alzheimer's space, and we have that expertise. We have the expertise in incretin. And so if there's a pathway there for the future, we'll go after it, and we have that expertise to incorporate. But again, I see this as a -- on the learning journey that we've been on for the last three decades will incorporate the incremental data point and put that back into our funnel of innovation to see if there's something that we can do about it.

Yes. So following up the conversations on indications. If you look at mechanisms, so eloralintide, the amylin agonist, we just -- you had recent data at obesity week. They look great. Talk about how you would prioritize a mechanism like that over an incretin or GLP-1 type of mechanism, and maybe how do you sort of balance the -- what indications you go after for amylin versus GLP-1?

Yes. I guess -- well, first, the data readout that we had in obesity week with eloralintide in the monotherapy setting is an exciting kind of next step for us in having a suite and pipeline of assets that can make a real difference for people in kind of the wider lens of spectrum of where you are on living with overweight and obesity. And so eloralintide, we see -- if you take a look at the profile, it may have an improved tolerability profile, and so it gives you optionality on monotherapy. So whether it's entry or in combination, we're -- we should have data on the use of eloralintide with tirzepatide next year. And so that could be a component of either sequencing or a combination at the entry point. It could also similar to comments I made with orforglipron in maintenance setting. It could also be a good option. And once you have match our goals from a weight and health standpoint, could it be a great maintenance therapy as well. And so the different components that we know on the value of incretins and other elements, whether it's cardiovascular health or other properties in inflammation, that's something that we still need to develop our understanding of amylin, but we're excited about where this fits in. Maybe thinking back to your kind of question related, how do we see eloralintide or orforglipron or Zepbound or you haven't asked yet but retatrutide, how do we see all of those being positioned. It's interesting, this is coming on to like next year will be my 30th year at Lilly, and we've seen a lot in the diabetes space over time with different mechanisms, playing a significant role in each innovation provides an opportunity for us to enhance treatment and outcomes for people living with diabetes. And I see obesity may be in the same kind of parallel to what we saw in diabetes decades ago and over time is that each mechanism in each therapy added to the space only increases the ability to actually get greater outcomes overall to the greatest range of patients, both their initial composition as well as their preferences and their goals of treatment. And so having a suite of medicines and mechanisms provide us the greatest ability to tackle obesity and the outcomes related to obesity from a health standpoint. And so they all have their ability to position in different subsegments. But in the end, it's actually the accumulation of those medications that provide the greatest benefit.

Yes. And then, I guess, one of the last questions, and we naturally focus on incretins and metabolic health, but you do have a pretty diverse portfolio, right? So maybe when you look at oncology versus I&I versus neuro, what -- or maybe some of the pushes and pulls, we can think about as you look to next year in the non-incretin portfolio?

Sure. Well, it's exciting across the board because we're launching in every therapeutic area, and we have exciting science and medicines that can really improve health in each of these categories. Maybe on the pushes and pulls, obviously, some of our legacy medicines, whether it's Trulicity, Taltz, Verzenio, you should assume kind of continued kind of decline in growth or the continued trajectory that they're on. I don't see any kind of step changes in those medicines. At the same time, if I look at each of the therapeutic areas, there are exciting components and catalysts for growth in neuroscience or in Alzheimer's because some -- I think the two key components there is that we've -- one, we've established Kisunla has a great medicine and obviously positioning it well within the market and gaining traction and share. The key there is to grow the market. And the friction that exists in being able to diagnose early Alzheimer's is a key component. And so the advancement of blood-based biomarkers and the ability to confirm diagnosis early is going to be a key component there. And also the readout for preclinical at some point, it will be a catalyst if positive for us to grow the overall ability to create outcomes and maybe prevent some of the symptoms related to Alzheimer's. So that's an exciting area of growth and trajectory and catalyst for growth in the future. In immunology, Ebglyss is the key component in catalyst of growth. It's obviously a growing space in atopic dermatitis. We're continuing to see good traction in -- for Ebglyss, and the key there is to gain beliefs and traction in first-line therapy. And so I'm optimistic that, that will continue to be a growth driver. And then lastly, in oncology, obviously, we have two key medicines that were in the midst of still continued launch. Jaypirca probably has the greatest propensity and catalyst for growth. We're anticipating approval any day related to the expansion of our label for incorporating BRUIN-321, where you have ability to expand the number of population eligible for treatment. That's already incorporated NCCN guidelines after ABTK failure. And so optimistic about our growth trajectory on Jaypirca, and obviously, we just launched Inluriyo. It's still in its first indication and probably later indication in an adjuvant setting are the greatest opportunity, but it's an important start for us to launch Inluriyo in the market. And so -- and each of those spaces, it's exciting. We have a catalyst for growth outside of incretins but obviously, incretins play an outsized role in our growth trajectory over the coming year.

And then last question, Ilya, and I know it's not your primary, but if you look at sort of external innovation through BD or M&A, there's a lot to work on inside Lilly in-house. To what degree do you -- how is the thinking evolve to looking externally to be additive to the portfolio?

Sure. Well, we're quite active. We're active across the board in kind of maybe if I categorize two different elements. One is in the therapeutic areas where we've decided to put focus, we were very active in enhancing our overall pipeline in each of those areas. That's an important element. We're probably -- we're active in each of those therapeutic areas. The other one is related to platforms, platforms that we believe can have a long-term view maybe even beyond the therapeutic areas that we're in can play, whether it's in genetic medicine or even the work where we've announced with NVIDIA related to AI and incorporating our ability to advance innovation and accelerate innovation. That is obviously a key component for the future that's going to take time to evolve, but that is an important element for us to grow beyond this decade is to increase innovation outside of just our therapeutic areas, but the platforms we believe have the ability to have traction beyond.

Great. Thank you very much. It's been a great conversation.