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

Great. Good morning, everybody. So thanks very much for joining us for this next session with Eli Lilly. On behalf of SVB Securities, it's very much my pleasure to welcome Ilya Yuffa, who is Executive Vice President and President of Lilly International Operations. So Ilya, I thought it would be great to have you start off with some opening comments given the phenomenal momentum that Lilly has, and then we'll dive into Q&A.

Sounds good. Well, Dave, great to see you, and thank you for hosting and interest in Lilly. Just for perspective, this is a pretty exciting year for Lilly and Lilly International. There's -- there are a number of components, as I think about our fundamentals of our growth brands that we currently see roughly more than 2/3 of our business coming from our growth brands currently. And that's in advance of launching in a number of new spaces. And so this year really is an extraordinary time for us not only to capture momentum in a number of growth areas. We're still early in our adjuvant launch for Verzenio. We have significant growth momentum in the back end of the year on Jardiance and Taltz in international. And then we see a number of launches in a number of familiar spaces like in diabetes with introduction of Mounjaro, but also some new spaces within hematology as well as in GI with Jaypirca as well as mirikizumab. And so we're -- it's an exciting moment for us to have an impact for patients globally, but also to drive additional growth momentum. And we have a number of catalysts of growth across all of our therapeutic areas. So really excited to lead our international team and to play a significant role in the growth of our overall enterprise.

Phenomenal. So just to put the business in context that you're specifically responsible for. So Lilly International represented about 36% of 2022 global sales and it's a $10 billion revenue run rate operation. So could you provide a little bit more color on your vision for international expansion, including how Lilly is leveraging partnership opportunities despite being a very large entity?

Sure. I'll maybe tackle 2 components of that. I think first, if I think about the potential of international relative to the U.S., there's significant opportunity. And over time, I think we've improved the cycle time of getting to a more simultaneous launch of our innovation. And so historically, there has been some lag. I think we've gotten closer to simultaneous launch. But the life cycle is a little bit different. We had some headwinds around LOE last year in Japan. We had some exposure in different cycle time in China. But we're moving towards more simultaneous launch. So overall, I see international having more consistent growth, if not even better growth overall relative to the enterprise on a go-forward basis, and that's my goal with my team is to drive that. There's -- the potential is there, and so we need to execute around that. And I think just look at Verzenio adjuvant as an example. We're still early in launch and still gaining reimbursement in a number of our markets. So there's a little bit of a lag outside of the U.S. in gaining reimbursement. But we've been successful in improving our capabilities there. And so I see that as a significant opportunity. As it relates to partnerships, probably there are several different components of partnerships that we pursue in international. There are strategic markets, I would say, probably Japan and China, where we have leveraged local capabilities and scale to increase the ability of launching to an expansive market in a number of different therapeutic areas. So for instance, in Japan, we announced and we've had historical success in launching a number of our products, whether it's with Cialis or Emgality or Trulicity. We now have Mounjaro as well, where we utilize a local player that drives scale capability to help us broaden our reach and increase the ability to leverage the opportunity. Same thing with China. We've had a number of partnerships. Innovent is probably most significant partner in oncology, where we are leveraging local capability and investment so that we can actually expand our overall revenue and growth opportunity there. So that's kind of a strategic partnership where we still participate and have significant part of the economics. We don't give up our overall economics related to that. We just increase the ability to succeed there. The other part that we look at in partnerships is around looking in markets where they're smaller markets, where regional local players are willing to invest to get broader reach, and our goal is to have reach and impact to those patients, and so we do a number of distribution and promotion agreements in some of those markets. And so that's been a strategy. And then, of course, the third one is just looking at our legacy, and we're opportunistic on our legacy assets where it makes sense to divest and increase our focus in our growth brands and innovation, we do so. And to me, that's more of a leverage, our capabilities and our resources where we can drive additional growth. And if we need to divest or partner in different assets where it makes sense, we'll do that.

Great. And then you touched on China. So obviously, China has a lot of different considerations for any global biopharma company. Could you talk about how you work to make that business viable in the context of government price pressure and future geopolitical risks?

Sure. Listen, I think China is a significant market. It's currently -- if you take a look at overall revenue contribution, it's very close to the contribution of Japan. It's one of our largest markets. What we've done well in China is increase the level of access to our innovation in contribution to our revenue. So if you just look a few years ago, not 10 years ago. Just a few years ago, legacy brands represented 80% of our business. We now have our innovative portfolio representing 80% of our business. And so the ability to compete and introduce our innovation is a key component of being successful in China. The speed to which we can bring innovation to China is an important aspect of managing our overall risk profile, partnering with capable and similar value and companies that understand the integrity and ethical component of how we operate in China is important as we think about risk management in China. We obviously have an extensive compliance and integrity program in China as well. And so that will continue to play. So for us to win in China, like last year, we took -- there was a step change in pricing dynamics to increase our access to innovative portfolio. We don't see that as significant of a -- to have a negative impact in 2023. And so you'll see greater net volume growth in China this year. Obviously, there are some dynamics in COVID that still plays out in our infused oncolytics portfolio. But long term, we see more partnerships in China as playing a growth driver, bringing innovation faster in China will be an important component. And being mindful of geopolitical risks and also how we operate in China is important, but we see it being an important contributor to overall success, and we think we have the right pipeline and portfolio to drive success and my team there is focused on strong execution.

Excellent. One more sort of macro question before we dive into diabetes and obesity and the pipeline. So with respect to austerity measures in Europe. It's hard for us on the outside to put into context and keep track of what's happening when and how impactful some of the actions are. So I've heard, for example, that there was a price reduction across the board in China. I mean, I'm sorry, in Germany recently, but I don't have details on that. So could you help us understand what specifically has happened with respect to austerity measures in certain major markets and what's on deck, what's coming next, if it's public information?

Sure. So I'll maybe give some context historically in Europe. I think we saw roughly in the past, roughly a single mid-digit price decline overall portfolio of Europe, generally speaking.

Annually? Okay.

Annually. And so that's been consistent over time. I think what we see currently in austerity measures, specifically for Germany or France and a couple of other markets in Europe, is that there was a pressure, I think, globally on inflation. We saw energy crisis, some impact of Ukraine war impacting budgets across Europe. And so there were some onetime incremental austerity measures that impacted a number of industries. But our industry as well, like Germany had a step-up in the payback that the industry had to give to -- back to government on overall sales. But generally speaking, the impact is still in the mid-single digits. So it's not a step change in overall dynamics in Europe. However, as an industry, we do feel like the pharma budgets are still relatively low relative to overall health care budgets. And so we're making some signals to government that they need to look at budgets overall and not only look at the pharma industry to pay back and help on the budget side. One market in particular that I think is of note, it's less about austerity measures and more about just the structural system in the U.K., where they had a voluntary scheme and system, where we as an industry negotiated a number of years ago that now, the payback is in the high 20%. And for a voluntary system that the government is saying they are pro-innovation and want health care to be an important driver for the -- as an industry in the U.K., that goes contrary to that. And so we left the voluntary system as a signal to government that we don't voluntarily pay high 20% as a component. And the statutory is roughly in the same ballpark. So it doesn't change our economics and what we expect in the U.K. But of course, as an industry, we need to have a better environment in the U.K. to be more pro innovation for the health care and improvement in health care in the U.K. And we're at the table this year to renegotiate '24 and beyond. And so we thought it was an important signal and industry needs to advocate for a better environment. We are well positioned as a company because we have a number of growth drivers. And so the overall net impact to us is that we continue to see Europe as a strong growth contributor. Our fundamentals of execution are strong. But we need to, on the policy side, advocate for pro innovation.

Got it. And then just to recap, so you're still expecting roughly mid-single-digit net price decline in Europe in 2023.

Correct.

Okay. All right. Excellent. So then turning to diabetes and obesity. I'm sure you can't wait to get your hands on some [ Mounjaro ] sell, but U.S. demand has been unprecedented. And so could you discuss the ramp-up in manufacturing and put that in context and help us understand whether you can really launch Mounjaro and when in major markets ex U.S.?

Sure. Well, as a first, I think what we've seen and we knew when we saw the results of SURPASS that Mounjaro profile is pretty extraordinary and has the ability to fundamentally change the expectations of providers and for patients. And that's what we're seeing in the uptake in the U.S. is that the utilization of Mounjaro and incretin in that earlier diagnosed diabetes patient is significant. That opportunity and class growth overall of incretin is significant. We should expect that not only in the U.S. but also outside of the U.S., and we're seeing an improvement in overall GLP-1 utilization outside the U.S. as well. Now in terms of ramp-up capacity and also launches of Mounjaro outside the U.S. We expect to double the incretin capacity by the end of 2023 based off of our investment in increasing capacity. RTP is probably that next step-up in node of capacity, and we're making great progress in RTP. And so we expect to meet our goal of expanding capacity and doubling by the end of the year. That allows us to, even with the momentum we're seeing in the U.S., to allow for launches outside of the U.S. So we anticipate a launch of Mounjaro in Japan in the first half of the year. And we do expect to see launches in other major international markets throughout the year. Obviously, there are a couple of components of -- that we need to monitor. One, of course, is the making sure that we see the step-up in capacity. The other is we're in parallel. We're not just waiting around for capacity. We are negotiating access in a number of markets for any therapy outside of the U.S., it takes time to build up access and reimbursement. And so there's typically depending on the market, a 9- to 12-month lag from approval to access. And so we're continuing those discussions in those markets so that when we have the ability to trigger a launch, based on capacity, we're ready for it, both in reimbursement and also supply. And so we do anticipate having that -- those launches happen this year. And of course, as soon as we're able to, we will launch and our teams are ready.

Got it. And could you -- I know that you're not in charge of manufacturing, but could you talk, particularly since you're on the executive committee for the company about capacity increases beyond '23. So we have a better understanding of the ramp ahead since doubling capacity isn't anywhere near what the global market requires?

Sure. Yes. listen, I'm in -- as you can imagine, I'm in close contact with manufacturing, both in the Executive Committee and just routinely, but the manufacturing team have done a phenomenal job to actually deliver over what they've planned in our current nodes of capacity. We've also announced a number of investments. We talk about doubling by the end of this year. But we've also announced investments in expanding RTP, so multiple lines in RTP. We also announced and already started developing our site in Concord. And so additional investments also in Indiana and nearing in Ireland as well. And so we have a strategy to expand capacity over time to meet the demand. So that's an important aspect is that we're not just settling for the first node of capacity. We need to continue to invest in capacity to meet the demand. I also see long-term view of incretin, both in type 2 diabetes as well as in chronic weight management to meet the overall demand and needs to have a portfolio approach. And so I'm excited about not only Mounjaro, but also if you look at our GGG program as well as our oral NPA. That portfolio will be important to progress in order to meet the overall demand in -- especially as you look at chronic weight management that is still very -- it's not mature yet. It's really -- not many therapies are available currently. And so as we launch in chronic weight management, that will be an important factor.

Excellent. And could you help us understand GLP-1 pricing in major ex U.S. markets relative to U.S. net pricing?

Sure. Listen, we don't get into the specifics of our pricing in each market. At the same time, it's fair to say that overall pricing in general, not just GLP-1 net pricing outside of the U.S. is not as great as the U.S. Part of that is driven by single-payer markets. And so you get broad access from the beginning. So there's advantages of that, but that also has implications on overall net pricing. And the system is geared towards looking at comparable therapies in market for introduction of any new therapy, and each system is slightly different. So Japan, China, Europe, they're all different in the way that we price. But in essence, we're maintain our competitiveness in the categories. And for Mounjaro specifically, I would say the profile and the data suggest it should have a premium to existing incretins in the market, and that's our general strategy is to have a premium for Mounjaro relative to other GLP-1s.

Excellent. Okay. And then just back to the capacity question. So clearly, the demand for Mounjaro for the treatment of obesity, it would likely outstrip supply for many years ex U.S. So could you help us understand that, put it in context, how you plan to introduce Mounjaro for obesity and whether you'll just, I don't know, I'm sure in certain markets, it will be out-of-pocket spending and maybe that's enough for Lilly. Maybe Lilly could create a multibillion-dollar brand just on cash pay. I'm not sure. So if you could frame that and how you're thinking about it, that would be very helpful.

Yes, listen, David. I think one aspect I think is important to know in context of diabetes versus chronic weight management and the opportunity. I mean look at diabetes and the overall utilization of different classes and different therapies and different competitors over time. You have Metformin, sulfonylurea, DPP-4, SGLT2, GLP-1, insulins and numerous brands in each of those classes. And over time, that's grown. And there's still significant opportunity of growth just in that space, growing GLP-1 utilization. Chronic weight management is a significant market. So you look at over 650 million people globally that are probably overweight or obese that fit as opportunity, you don't really have any therapy that's been on the market for too long that addresses this population, both in terms of access as well as utilization. So internationally, you see liraglutide being used for chronic weight management. And even that with 5% weight loss annualized is trending just south of $1 billion. It's mostly out of pocket. You do have some markets that have access for chronic weight management in some like U.K. and some European markets for those that are above 35 BMI and additional risk factors. And so I think it's going to take time to, one, educate around obesity as a disease. It will take time to gain access as we get additional outcome data or subpopulations where governments decide to prioritize for chronic weight management. And then you would expect to see, like you do today a sizable out-of-pocket market. All of that said, while significant, will take time to evolve the overall demand in those spaces. And each market will be a little bit different. I think of them as archetypes. So you have an archetype that you have already significant chronic weight management use in out-of-pocket. You have some markets where utilization will be first in the high-risk populations and well it be important to have access first. And so it'll take time. So back to your capacity question, our capacity needs to evolve towards that demand. And it is not just a 1-year impact or 1-year investment. We've included significant investment, and we'll continue to invest to broaden our capacity. And I think the evolution of overall how we meet demand with supply and also our portfolio will need to evolve as well. And so this is a dynamic market that we will have to learn from. This is a new space, and we're committed to investing both in the education, driving access and driving our pipeline and capacity to meet the overall opportunity.

Excellent. That's very helpful. And then pivoting to the pipeline. So it would seem that the oral GLP-1 that you have in Phase III now would represent a much bigger opportunity than Mounjaro, given the fact that it could be manufactured much more easily and at a lower price and thus, maybe a more important product for you internationally in 5 years than Mounjaro. But would love to get your thoughts on being able to take that globally in a much bigger manner than you can take Mounjaro given its supply constraints.

Yes. Yes. Listen, David, I think there are several components there. One, the profile matters. So it's not just being an oral, but an oral that has a profile that is competitive to basically some of the leading injectable therapies that are currently on market. And so that profile is important. We know from our experience with Trulicity that once-weekly injectable is sometimes actually preferred versus oral. And so I think there will be a dynamic where you have physicians as well as patients having preference for different therapies depending on what is better for them to incorporate in their life, whether that's type 2 or chronic weight management. And so I think what's important is that there's a significant opportunity. There are some markets that are more oral-based. Japan is a greater oral market in diabetes, especially. And we see a few other markets being similar. And I think it will -- what will play out is that we'll have multiple therapies that have a variety of benefits, either from a compliance or efficacy or both. And I think having the portfolio to have an answer for the continuum of care and life cycle of the brand or maintenance, that's the important piece. And for international, it's important to have all of those options available.

Great. Very helpful. And then turning to neuroscience and specifically donanemab. Could you talk about the opportunity for donanemab ex U.S., if it's successful, and if you could weave in any comments on factors such as testing requirements, ongoing monitoring for ARIA, potential IV [ center ] bottlenecks, et cetera, that would be very helpful.

Yes. I would maybe put donanemab in Alzheimer's in general. And I think there are 3 components that are important in order to really make a mark and have an impact in Alzheimer's. It's a devastating disease, both for those that are impacted directly or it's probably one of the most impactful for caregivers as well. And there are 3 areas that are important to drive ecosystem wise. The first one is diagnosis. So the diagnostic ecosystem is different and variable in each of their markets. So Europe, for instance, the standard currently is CSF as a diagnosis. That's different in other markets. I was just in Netherlands recently, and there are a number of memory clinics that drive kind of centrally some of the diagnosis. That doesn't exist everywhere. So the diagnosis piece is an important component. The second is driving access, having access, being -- and you see this in the U.S. as well is CMS. That's no different in a single payer environment. Access is important. But even if you get those first 2, the third component is the education and understanding of where donanemab or other treatments can have the greatest benefit given some of the risk parameters they mentioned, whether it's ARIA or just in general, where do you see the greatest benefit for therapies. And I think it's going to take some time to drive the ecosystem in all 3 parameters, and there's going to be variability in each market where we are. And so we need to invest in that in the long term. Long term, it's a significant opportunity. I look at Japan. Japan in absolute numbers has the same number of patients that suffer from Alzheimer's as the U.S. And so it's a significant opportunity, but we need to drive all 3 components in order to have success. Long term, I think it's there. It's going to take time to evolve because the ecosystem is just nonexisting.

Got it. And since you mentioned Japan, I'm assuming that if the ALS2 trial is successful that you'd be filing in Japan?

Yes. No, we have plans and we have in discussions to prioritize Alzheimer's. It's a super aging society. And so it's -- Japan is an important market for us for donanemab. So as we get TB2 data, our plan is to file as part of a full package for donanemab in Japan and also the rest of the globe based off of TB2. That was the original plan to begin with.

Got it. Okay. Very helpful. And then one final question. So you have tremendous experience and background at Lilly in many different roles. And I thought since we have you today with us, it would be a nice opportunity for you to talk about potential underappreciated opportunities ahead that may not be on people's radar screens.

Yes. And Dave, I've been with the company 26 years. And I've seen us in a number of different therapeutic areas have strength in one and maybe some catch-up in others to drive pipeline and have catalysts for growth. We're currently in a stage at the company where each therapeutic area has both near-term growth catalysts and long term. So if I think about underappreciated assets, I also think there's underappreciated story around Lilly is around strength in the overall enterprise with each therapeutic area driving into some new fields and catalysts for growth. Look at oncology. We have Verzenio being a significant driver of growth near term, especially with adjuvant and growing our MBC. But we also are growing in hematology with Jaypirca has a significant opportunity to be competitive in a new space and grow overall oncology. In immunology, we have strength in dermatology and rheumatology with Taltz and Olumiant, but now we have the opportunity to enter a new field with mirikizumab in GI and grow our overall immunology portfolio and also introduce lebrikizumab to leverage our already strong footprint in dermatology. And then we have diabetes. And we have, of course, Mounjaro and our overall incretin portfolio, we also have a once-weekly basal and growing pipeline behind Mounjaro. And then neuroscience, I think this is going to be a significant field to develop over time and having not just donanemab, but also a follow-on for donanemab already in Phase III. And so we have significant catalysts for growth in the near term. And we are building out our pipeline in every therapeutic area so that we are not just dependent on any one asset to grow. We have all engines really ready to execute across the pipeline and commercially. So excited about the growth opportunity we have ahead of us.

Excellent. Well, that's a great way to finish up. We are out of time. Thank you so much for joining us, Ilya, and hope you have a great rest of the conference.

Thank you. Always a pleasure, David.

All right. Much appreciated.

Okay, bye-bye.