Great. All right. Thanks so much, everyone. I'm Terence Flynn, Morgan Stanley's U.S. BioPharma Analyst. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. This afternoon, I'm very pleased to be hosting Eli Lilly. Joining us today from the company is Ilya Yuffa, who's the company's Executive Vice President and President of Lilly USA and Global Customer Capabilities. But appreciate the time this afternoon.
Yeah, great to be here.
I'm really looking forward to the discussion.
Yeah. Appreciate it. Thank you.
I figured we would start with obesity. Not a surprise.
Yeah.
The company has one of the broadest portfolios in the industry here, and I think a question we get a lot is just how to think about segmentation of the market, because again, you guys have a broad portfolio, but there are a lot of different subcategories within this disease. Maybe talk to us about the long-term vision in terms of how you are positioning the portfolio based on the current portfolio, but also some of the new medications that are in development as well.
Sure. Well, listen, we are equally excited about what we do in obesity. Obviously, as we think about long-term portfolio, we think about how do we ensure that we cover different needs from different populations. Obviously, it is easy to say anyone who lives with overweight and obesity, you can solve all problems with one medicine. I think the reality that we are seeing is that there are a lot of different needs, whether it is around how people enter their journey of health, whether how they maintain or different aspects, whether it is different health benefits and different indications within this space. We are looking at different mechanisms, and the idea for us to have a broad set of medicines and portfolio to answer those different needs is an important element.
Whether or not someone enters their journey on an oral therapy like Foundayo or intensifies and needs a different mechanism or multiple mechanisms to solve their needs, we believe that having those options are critical to meet patients where they are. Obviously, tirzepatide and Zepbound is foundational. It is setting the standard of care and preference for most physicians and people that are in their current journey. But we have to be honest that the current utilization of obesity treatments is still low. We are still in the single-digit utilization of people that could benefit from these medicines, so it is important that we have the broad set. Foundayo, we have now Zepbound, obviously there is a lot of interest on our side for retatrutide.
Then we are also exploring eloralintide and other components that could improve on different aspects, whether it is tolerability, frequency. That is our vision, is to have a broad set of portfolio. I am sure we will cover this a little bit later, but we also believe that in this space in particular, is very consumer-oriented and having a broad portfolio that people can have a relationship with the company and the experience that they have as a consumer is an important element beyond just the portfolio.
Yep. Okay, great. I know we will unpack a lot of this in the subsequent questions, but I think it is important, as you mentioned, unless someone has coverage, they are not going to be able to benefit from the medication. So that has obviously been a big focus. Where do we stand in terms of the commercial coverage, and how do we think about some of these wrapper services that we are hearing about, and where does that fit in the strategy as we go from this year into 2027?
Yeah. I think on the commercial side, we have been relatively stagnant on 50%. We have seen some employers recently remove coverage. We are also in discussions with many employers on adding coverage. While I do not see a step change coming into 2027 on either direction, there is a lot of movement that we need to still have within this space. Probably the single largest driver of increased access is Bridge in Medicare. We are seeing obviously good initial uptake and people taking advantage of the Bridge program. We also see some states on the Medicaid side starting to add coverage. On the employer side, we have our Employer Connect and conversations with a lot of employers about the different options, whether it is PBM or Employer Connect program, to add coverage and flexibility in the employee cost sharing as part of that.
I do anticipate that that will move, and as the body of evidence on the direct health economics of utilizing these treatments will show a benefit of employers investing in this space. We just published a study around Zepbound cost of care. I believe more and more evidence will point in that direction and will increase over time.
Before we get to the cost effectiveness study, just one follow-up on those wrapper services. Are you seeing anyone leaning in yet aggressively there, or where does it stand in terms of is this just preliminary conversations or actually seeing employers embrace that program?
No. We have a network of more than 20 third-party providers that are actively having conversations with employers. Our team is also having active conversations, and I believe we will have a number of employers opt in or maintain coverage through this program.
For 2027?
For 2027.
Okay.
Yeah, because this is the cycle for typically you make your benefits decisions around this timeframe. Usually before October to announce what you are covering in the next year. We anticipate a number of companies will enter through this space.
Yeah. Okay, stay tuned. You mentioned the cost-effectiveness study. Again, maybe just walk us through the key takeaways, because I think that has been partly what you hear is just, "Well, we do not really want to pay for the upfront cost because we do not know what the downstream savings is." But now it seems like there is some data that is starting to bolster this argument. What did you guys find in this study?
Yeah, I think one of the important aspects that I have seen improve over time is that the conversations with employers and payers, there is now a good conversation understanding of the health benefits of obesity treatments. The greatest challenge has been around anyone's P&L. Around, okay, but what is it in the direct cost? They may agree that there could be some indirect benefit, good on the health benefit, but what does it mean to the near-term bottom line? What we looked at is around direct medical costs for people utilizing Zepbound. Now, this particular study had 55 and over, and what we saw is that you get savings as early as six months.
You start seeing savings in six months, and then once you get to 12 months, you can get upwards to $600 per month per person of benefit, which more than offsets the cost of the medicine. We believe that that accumulation of evidence will start to increase, which should convince many employers and payers, and obviously Bridge, you will see a significant amount of savings by investing in the space. Listen, it will take time and more than just one study to change the complete calculus for many employers, but it does catch people's attention, and it should.
You mentioned the Medicare Bridge program. As you think about the rollout there, any points of friction that you are seeing at this point in the rollout or anything you would point us to?
I think one aspect that is important that not everyone understands, the friction in the healthcare system is real when it comes to obesity treatment. In most plans that you see on the commercial side, you have variability on criteria. Every plan has their own set of prior authorization and what is allowed, what is not allowed, the different comorbidities, the different BMI. One unique aspect of the Bridge program is that it is a unified set of criteria on people that different BMI, different comorbidities, but it is standard across the entire Medicare eligibility criteria. That is an important element as we see what is being implemented. The other piece is that just the mechanism and the logistics of Bridge, having a program at large scale work in the first few days.
While there were some minor hiccups here and there, overall, it is working really well. What we are doing is educating physicians, pharmacists, consumers on the eligibility criteria. The process itself to go through the PA and the denial through Part D to make sure that the aspects that are excluded, they go through Part D. The ones that are included in the eligibility criteria then get reapplied, and it is an automatic process. We are seeing pretty significant uptake of number of people actually coming through Bridge. I think Dr. Oz quoted close to 600,000 people leveraging access to medications within Bridge. Really positive just from a logistics standpoint, an important piece at $50 standard out-of-pocket for people with Medicare that are eligible is a terrific program.
How does that 600 compare to what you would have guessed if you said six months ago, there is going to be this many people on it in the first two months or something?
Listen, as always in this space, we have lots of different scenarios, and we know that having one forecast, every forecast is going to be wrong in some direction. I think one of the things that we were really positive about is the criteria. We're really positive about the $50 out-of-pocket, which is standard. We predicted that there would be reasonable uptake. We also knew that there were a number of people in self-pay in the LillyDirect Program that were Medicare eligible. What we're seeing is predominantly new patients coming in, so 60%-70% being new.
The other probably not surprising for us is that when you have a standard of $50 out-of-pocket, there's been a preference towards injectable and a preference towards Zepbound in overall Bridge program. That part I think we expected and we're pleased with how the whole process has been working.
Okay. Great. I think just to remind people, I think you said, what, 18 million to 20 million eligible people potentially?
Yeah. Around 20 million eligible based off of the criteria that we estimate. Then, again, what we're seeing is around 600,000. You're seeing obviously for Zepbound when you look at our trend, it's KwikPen that is available through Bridge. It's also available for self-pay. All of the growth there. We're also seeing good uptake of Foundayo as part of the bridge program as well.
What do you think happens at the end of 2027 with the bridge program?
Yeah, I think with the significant uptake and also even our own cost of study, like Zepbound cost of care, and knowing that there is significant savings, that will be a program that if there is anything that continues, it is how do you ensure that we continue this program because of the health benefit, reduction in hospitalization, savings to overall Medicare program. I think this will be a net positive towards finding a solution past 2027.
Okay. The other thing you mentioned is, again, the consumer orientation of this market, which has been kind of N of one or maybe N of two. There is maybe one other case study you can look at, like aesthetics, for example. As you think about that, it has become, I think, what, 40%, 45% of the business in the U.S. How do you think about leveraging that, leaning into that on the forward, and is this something like a subscription service? We see what Apple has done with their ecosystem, for example. So is that a possibility given the breadth of portfolio and the success you have had around Zepbound, or are there other iterations of this?
Yeah, I think, when we first entered with LillyDirect, it was an experiment. Solving part of the problem is ensuring that the transparency of our pricing actually gets to patients. I think what we found in launching this in obesity, that it is more than that. You reduce some of the frictions that exist in the healthcare system, especially in a disease area where there is a lot of stigma and there is a lot of variability in how you actually get access. So breaking down some of those barriers are real. I think you should expect to see more experimentation, whether it is around pricing or around looking at our portfolio or looking at how do you do wraparound and embed that into the consumer experience. What other components on how you start therapy?
Are there other elements beyond obesity that are important for consumers that enter their journey through obesity? All of that is something that we're interested in, we believe adds a lot of value. To your direct question around subscription, we've had a journey program, which is a similar concept in kind of e-commerce, related to if someone fills their prescription within a certain number of days, they continue on a discounted price. Looking at ways on people entering therapy, on reducing friction, on how you stay adherent to therapy and get the most of what you're trying to achieve in terms of your goals. These are all elements that we're embedding and, one, starting to experiment and enhance our LillyDirect experience within obesity.
I do see components of other disease areas that we're either currently in or in the future that we'll be in that could have some aspects of the consumer that will play a larger role.
Okay, great. Maybe I want to pivot to Foundayo launch. As you look out now through the end of the year, maybe just give us an update on kind of the latest metrics and then how to think about those tracking through the end of 2026. Let's focus first on the U.S., then we'll go ex-U.S. second.
Sure. Sounds good. Well, first, there are a few different components that I look at just from a discipline around execution and how we launch any brand. There is a component around consumer awareness that's important as you build out a new brand. Excuse me. That's something that we've put a lot of attention to. The second is--
I did see a new commercial during the US Open.
Yes. I'm glad. The second is around, do HCPs and physicians understand the profile of Foundayo and have they actually tried it with patients entering the journey so that they get experience and understand the real-world efficacy and tolerability of Foundayo? Then I look at some other parameters around our field execution. So maybe on the consumer awareness piece, we've amped up our consumer advertising and awareness of Foundayo. We just recently launched an ad with Martha Stewart. We're hoping that will build out some level of greater consumer awareness and consumer interest. The other piece is around the trial. I think we shared during our Q2 results that we've increased the number of trialists to over 36,000. That's continuing to increase, so we see progression around trialists.
The other encouraging indicator is that for the people, the physicians that have tried to use Foundayo with their patients, have they moved to adoption? We are starting to see that also move in the right direction. Obviously, from our field execution, ensuring that physicians have samples readily available if they need to start a patient. We have improved on our access and coverage for Foundayo. We are doing a number of peer-to-peer programs so that physicians can talk to other physicians around the profile of Foundayo. A lot of our leading indicators are moving in the right direction. The outcomes, of course, you guys and I look at the outcomes of that. We are starting to see movement in our share.
We now have more than 30% share in new starts within oral GLP-1. We are starting to see some progress, and that is a marked improvement just in the last two months of the new starts. We are heading in the right direction. It will be a gradual move, and we are moving in all segments on the covered space, on the commercial. We are moving in bridge, and we are moving in the self-pay. Obviously, with self-pay, you have to look at the mix around most of the starts are in self-pay currently, and that will shift over time, and those are at lower price points initially, until people get through to higher doses.
Do you guys think you can get to over 50% steady-state share in the oral side as you think about the profile of the medicine and what you have seen now over the last couple of months or so?
I challenge my team to get leading share in pretty much any market. If you asked me this question in pretty much every space, I would probably answer, yes. I challenge my team to get leading share. We have done that with [Trulicity], we have done that with Zepbound, we have done that with Jardiance. We promoted it. We have done that with Mounjaro, and we will continue to challenge our teams to do that with Foundayo.
Do you think you can get there by December, end of December?
I will not commit to a time where we get there, but we are continuing to make progress. I think we have to continue to drive new trial. I am convinced that the experience itself should play out in a positive way, and I am of course ambitious in what we achieve. In the end, my hope is that more people are able to enter their journey, and this is expansive and that has been our focus, that I would rather get there in a quality way and focus on the right patient population that can benefit, and that we expand the number of people that get treated. That is probably more important to me than any other aspect.
Okay. Maybe we will pivot to OUS. You guys have launched in a few countries, as you said on the second quarter call. I think the ambition is to launch in over 40 markets by 2027, which would be a very broad offering. And I think one of the key advantages, I guess, of Foundayo is it's a true small molecule scalable oral. As you think about maybe the second half of 2026, how should we think about the pace of that rollout? Then we'll talk about 2027 after.
Sure. Well, first, I think we've now launched in the UAE and the U.K., where we have approvals, and the early indication is that it's been positive and that it's been expansive. New patients are getting treated as a result of us introducing Foundayo, and there's interest in the oral segment for treating overweight and obesity. We just got approval in Saudi and also in Mexico, so we plan to launch there. It's submitted in over 40 markets. As soon as we get approvals, our plan is to launch. We have supply readily available. Our commercial teams are ready, so it's just a matter of the timing of those approvals. Those will be gradual over time. We'll enter those markets obviously predominantly for Mounjaro outside the U.S., it's a self-pay market. We have some markets that reimburse for Type 2 diabetes.
We have some, we just got approval for reimbursement in obesity in France. But it's still around 75% of the market outside the U.S. is self-pay, and as we get approvals, we'll continue to launch Foundayo outside the U.S. as well.
Yep. In those early launch markets, are you seeing that. It sounds like you are, but expansive to Mounjaro, meaning it hasn't really cannibalized Mounjaro. It's basically added new to GLP patients.
Correct. We see the total market growing and Lilly, in terms of overall share, is also growing both in Mounjaro because it's still early in our launch cycle for Mounjaro, and we're seeing new patients coming in with the introduction of Foundayo. We see it expansive.
Okay. One more before we go to the next topic is just on Foundayo, is just how to think about adherence persistence relative to injectables. I think that's another longer-term debate in the market, not just for obesity medications, but just for oral specifically.
Yeah. Maybe I'll provide some context to it as well. First of all, it's early days for Foundayo, and I think the first indicator is second fill, and the second fill data is very good. We see it being consistent with other oral medications and also not that far off from what we see on the injectable space. Context-wise, though, if you look at most therapies in the space, diabetes or obesity, probably the gold standard on adherence has been Trulicity, and we compare Trulicity to many oral therapies in diabetes space, and Trulicity as a once-a-week injectable therapy has always actually had greatest adherence overall, approaching that 16-month average adherence.
We're seeing that for Mounjaro and Zepbound to be in that same realm. So adherence being much greater than what we typically see in chronic therapy, and most chronic therapies have persistence that's less than eight months. That's something to contextualize. Now, this space is a little bit different in that many chronic diseases, a person taking a medicine doesn't always know or feel whether or not there's been a benefit until they go to their physician and get their blood work done to know whether or not it's been beneficial. Whereas in obesity, there is a component where someone sees and feels the benefit by staying on therapy. I do anticipate that we'll have probably better adherence than typical chronic disease. Will it be the same as injectable? We'll see.
I think that's the gold standard in adherence, but just to have context into chronic disease, you typically don't see as great of adherence as we've seen in the past with Trulicity and now Zepbound and Mounjaro.
Okay, great. The other thing that we and I think investors are watching is the rollout of generic semaglutide in some of these OUS markets. India, Canada, I think Brazil is coming soon. As you think about, is there an analog for how this could play out in the U.S.? I think the question is more around just not so much Mounjaro, because I think you're already seeing a lot of differentiation. People are voting with their wallets. They're effectively choosing it, even though in some cases there is a price differential over branded sema, but more so for the Foundayo piece. As you think about a GLP to GLP, not a GLP to two mechanism, but GLP to GLP, what does this mean for Foundayo as you see the generic rollout of sema in some of these OUS markets?
Yeah. I think maybe the first part is what are we seeing currently in those markets. By the way, this is not so different than what we've seen in the ED market in the past. When a generic enters, what you typically see is an expansion of the number of people that actually get treated. So that's what we currently see in both India and Canada, is that the market is expanding. What we're also seeing, although share naturally when the market expands significantly through generic share declines, but the overall volume, absolute volume, is continuing to grow for Mounjaro in those markets. Now, the moral of the story is that there's both a innovation and profile of the medicine does matter, where there's differentiation, where people do vote on what they feel could give them greatest benefit.
And there's a brand loyalty component from a consumerized market that also plays a role. How much does one play versus the other? Hard to predict, but we've seen that in the ED space as well, where there is actually very little differentiation in some of the space. Now read through for Foundayo, maybe I'll go back to your earlier question related to what is our ambition and vision of our portfolio, and having a full portfolio of different options in a consumer-oriented market is important when you enter and you stay in the ecosystem as a consumer. I think that's an important aspect that we believe will play out, and we do think Foundayo, as a true small molecule, also has some advantages on being able to be a truly once a day, anytime pill.
Yeah. Is there any of those markets that you think is more similar or different to the U.S. of the ex-U.S. markets? If you had to pick one that would be a quote-unquote "proxy." I know there's not an identical one, but--
It's difficult. I've spent four years running international, and what I can tell you is that the similarity is that there's healthcare friction in all markets. That's similar. This hybrid, you typically outside the U.S., you see predominantly single payer decisions on coverage, and then you see in markets where there's no coverage, it's entirely self-pay. There's really nothing in between. The U.S. sits at the in between where you are. Obviously, we need to grow access and affordability, but there's no single market that plays exactly the same as the U.S., but there are components that are similar.
Yeah. Okay. Maybe we'll just move on to some of the newer up and coming products in the pipeline. You mentioned retatrutide, elora . Maybe we'll start first on retatrutide. I think the question is just positioning in the market relative to tirzepatide. Again, phenomenal drugs set the standard of care on Type 2 and obesity. How do you plan to position this new injectable product relative to tirzepatide?
Yeah. We're really excited about retatrutide. I think there's a component which we knew as we studied in phase II on the higher end of efficacy and getting bariatric-like efficacy. If you take a look at some of our phase II results on the proportion of people actually moving from obesity to no longer being in the weight category and BMI of obesity is pretty phenomenal. I think it'll play a role for those people living with obesity that may not have enough efficacy in the current therapies that exist, where retatrutide can play a significant role, both for gaining access in that population, because you typically have even more comorbidities in that population. Also, excuse me, I think that the great surprise was in the lower end of the entry of retatrutide.
You see tirzepatide-like efficacy with only one step, and you have very good tolerability. I do believe it will play a role on both ends of the spectrum, on people entering their journey and finding that the lower doses of retatrutide can play a significant role. Still, the standard of care has been tirzepatide and Zepbound, and so I continue to see tirzepatide being a great standard of care. You see that on any of the results comparing against tirzepatide. It is a great standard of care and preferential treatment. It will take time to build retatrutide in that space, but it is good to have those multiple options, both in the higher end of efficacy as well as people just entering their journey.
Okay. Similar question, I guess, on elora. I think the thing that struck me from ADA was, Ruth made a comment that this will be the largest development program in Lilly's history in terms of a phase III program. Obviously, the company is very excited about this asset. Where does this fit, in terms of the commercial opportunity and s egmentation of the market?
Yeah. If you look at our phase II results, pretty encouraging on just efficacy in the monotherapy space and the tolerability. Even in the lower doses of eloralintide, the starting point, you get placebo-like tolerability with 13% efficacy, and you can get up to 20% efficacy in the monotherapy. Then we are also studying it with tirzepatide as well. Could you see an add-on or amplification of efficacy without compromising on tolerability profile? We believe there could be some significant benefit for people that currently do make that trade-off. Having those multiple options is a positive for building out the portfolio, and that is why the tolerability profile and how much efficacy you get as part of that can be a great both monotherapy as well as add-on for the future. We are encouraged by that program, in addition to retatrutide.
Okay. Then maybe one last one on obesity before we leave a couple minutes for Alzheimer's. That's just.
That's about right.
Long-actings, I heard you guys have talked about opportunity in the maintenance setting. So just maybe what's the market feedback there in terms of where potential long-actings could fit from a segmentation perspective?
Yeah. To me, I think it's less about long-acting. It's more about solving what is the actual consumer need and what are physicians looking for, and that's how do people maintain or adhere to therapy. There are different aspects to that. We talked about tolerability as being one, frequency or administration being another. Can a less frequent than weekly be beneficial? Yeah, we believe that could be beneficial. We're exploring options in that space. But we're looking at it as less about just a single asset or use case, but we're looking at all use cases on how do you answer the maintenance piece.
We have ATTAIN-MAINTAIN , we have SURMOUNT-MAINTAIN, that play a role in answering, to some extent, what you could do once you get to your goal, how do you maintain, and that serves one need to answer that question. Then we believe the rest of our portfolio can help answer the others.
Okay. We hosted Biogen earlier today. They obviously got approval of LEQEMBI subQ for induction. You guys, your message has been focused on, you've got a IV monthly versus their every other week. As you think about the near-term dynamics, do you think that that new subQ is going to change those shared dynamics at all, or you guys feel pretty confident in kind of the profile you have from a dosing data perspective?
Yeah. I think first, it's good to see innovation in this space because it's needed for a patient unmet need. We feel good about our profile. We have leading share now, but the profile of having once monthly, but more importantly, kind of the treat to a fixed duration until you meet the hurdle of removing plaque is an important one. The most important thing we do in this space is less about share and probably how do you improve the ecosystem. The time that it takes to get diagnosed and treated in Alzheimer's is if anyone here has anyone in their family or in their close network battling and trying to get diagnosed, it's a messy process and takes too long. The introduction of blood-based biomarkers is an important element of innovation.
How do you scale that as a standard for confirmatory and make the process from once you get diagnosed to treatment? We've made progress there. We've doubled the number of people that are treating, but there's a lot more to do here. I think both companies should spend more time in establishing an improved ecosystem for the benefit of people living with this awful disease.
Great. Well, Ilya, we're out of time, but thank you so much.
Thank you. Appreciate it.
Pleasure.
Yep. Okay.
Thank you.