All right, great. We're just about at time, so we can get started here. Welcome to day two of our healthcare conference. The weather is still holding up. Thank God for that. Very pleased to kick off our morning session this morning with Eli Lilly. We have Lucas Montarce, CFO, and Mike Zuppa, Senior Vice President, Investor Relations. Thank you, Lucas and Mike, for being with us.
Happy to be here. Thank you.
Great. I guess to kick off, Lucas, and we were talking a little bit about this at breakfast, we feel compelled, just given the external environment, just to start with a big picture question for all of our companies. That is all of these policy-related uncertainties that are bearing down on the pharmaceutical sector. It is now about 30 days post the first MFN executive order. What can you tell us about how conversations with the administration have been going? What is the status? Does it feel like there is going to be resolution anytime soon?
Yeah, no surprise. It's always the first questions that I'm getting in each one of the conferences. Unfortunately, there is not much details at this time. Going back to your question about the conversations, the conversations are positive in general. Again, they're very receptive and hearing our thoughts on what we are focusing on, that is basically how we reduce patient out-of-pocket in the US. We had good examples of that, similar to what we did, for example, with insulins a few years back, that we reduced the price of the product to a cap to $35. That's one of the things that we share with the administration. The other one is they are very interested in direct-to-consumer. Again, it's part of the executive order. We shared the experiences that we had with Lilly Direct.
As you know, we implemented this type of approach that we go direct to the patients a few years ago, very successfully now with Zepbound. Those are kind of the things that we've been sharing with the administration. Going back to your last question about anything imminent, we don't know at this time. It's hard to make any assumption about when, but they haven't shared with us any details at this time of how are they thinking about this and even the scope associated with that as well.
Okay. I guess in a recent press conference, the administration talked about that they would support pharma in negotiating prices with Europe. Have those discussions with Europe been happening? What have your interactions been on that front?
What we have seen so far is, and I think it's public information, you've seen that as part of the trade agreement with the U.K., they have included high-level language associated with improving the healthcare system in the U.K., including the pharmaceuticals as well, but nothing in detail. That's a first starting point. We are not aware of any engagement on this regard with the rest of the European countries at this time. As I mentioned, coming from all the U.S. markets as well and having experience in Europe, this will require regulatory changes. It is not up to the pharma companies to set up the price. There is a system in place that you go through based on the value proposition that you bring to the product. It is usually compared versus the standard of care in each one of the markets.
Based on that, it's set up the price either at a premium or at a parity to the standard of care. If we want to change that, that will require regulatory changes. Not much that we are familiar with or aware at this time. Coming from the conversations with the administration, what we discussed so far has been more focused on the U.S. side.
Okay, got it. Maybe we can just shift the lens a little bit more towards Lilly-specific questions. Just sticking with the pricing theme, obviously, it's very much top of mind for the GLP-1 class broadly on a number of different fronts. There's obviously the MFN-related concerns that have been brewing. Then there's, of course, potential PBM-related dynamics that could potentially affect pricing too. I guess starting with MFN and the Trump drug pricing policy agenda, how do you see that affecting the pricing dynamic in this market at all? How could it really play into potential pricing and really launch strategies? You've got Orforglipron potentially launching at some point this year. That's going to be a global next year. That's going to be a global product out of the gates. It's been framed by Dave as a sort of a GLP-1 for the masses.
Yeah. On MFN, it's pretty much similar to what I shared before. It's hard to speculate at this time implications from the pricing perspective. Thinking about new launches, you mentioned Orforglipron, to use that one as an example, our pricing strategy remains pretty much consistent, even with MFN, on how we think about pricing the products, which is based on the value proposition. It's early days, so nothing that I'm planning to share today about, again, defining the price for Orforglipron. That's how we think about for all our portfolio. Orforglipron will not be anything different from that perspective. You mentioned payer dynamics. You all have seen the announcement from CVS a month or two ago. Also, the other payers have confirmed open access for both, basically, incretins on the obesity space. That has been our strategy. We remain disciplined on our pricing strategy as well.
We are pleased, again, with those payers that provided open access. In the case of CVS, we see those payer dynamics happening all the time. That has been a factor in our guide and our projections for the full year. From the pricing point of view, we talk about, again, that our portfolio, our expectation was mid to high single-digit price erosion. Our view has not changed to that. That is a portfolio view, but of course, again, incretin is a big portion of our portfolio.
I guess, on the payer dynamic front, as you think about the current contracting cycle, are you seeing anything that would potentially suggest greater price erosion than the high single digits or mid to high single digits that you've laid out in your guidance?
No, I think it's very consistent.
When does that contracting cycle end?
Contracting cycle is usually for the next year, soon in the summertime.
Okay. Lucas, you've talked a little bit about sort of limited spillover into the commercial channel to the extent you do see pricing pressure on government channels. This market, however, is behaving a little bit differently than any other market we've seen in terms of the incretin portfolio. Just given the consumer element, what gives you confidence that those traditional barriers won't start to cave?
Yeah. I've been open about it, thinking about, in particular, the classes that we have been in the market for quite some time, including incretins in type 2 diabetes, that we have been able to maintain that separation on pricing between, for example, Medicare and commercial. We have been successful to do so over time. Very different payers, different, of course, patient populations as well. We have been very successful to maintain that separation. We do not think about this one anything different in obesity. I will add that in the case of obesity, we have also the out-of-pocket business as well that is growing very nicely. That is pre-pricing, right? Again, we set up the price ourselves, and it is completely separate from the negotiations with the payers as well. We feel good about that separation, even from the obesity space as well.
Okay. Maybe we can then pivot to the demand side. When you look at SCRIPT data, weekly patient starts for Zepbound have shown a very strong upward inflection. What can you tell us in terms of just framing demand dynamics at a high level, including any color on share capture from the compounding pharmacies? What are you thinking about the impact from the CVS formulary decision, which kicks in in a couple of weeks?
Yeah, maybe stepping back, very pleased, again, with the progression of the class first in terms of the market growth and penetration that we have seen. On top of that, you see, again, that after restarting, basically, our commercial efforts in Q4, we regained market leadership in the class in the first quarter of the year. Very pleased to see that. That is all very much in line to what I shared about the expectation for this year. Very much consistent towards our guide and our expectations. In terms of the continuation of the class growth, we continue to actively pursue that. Again, commercially, you see the DTC campaign out there. You see as well all the efforts that we do commercially. We continue to make progress on the access side as well. You see the opt-in moving from high 40% to high 50%.
There are new constructs that some of the payers are announcing, including Cigna very recently, that could potentially open it up more opt-in access for some employers that have not opted in so far. We continue to see great progress of the class and penetration. I do not expect to see any inflection point from my perspective. Going back to your question about compounding, it is hard to see what is the size of the compounding business. We have been open about this. And though we have been successful legally on all the court rulings that we have seen so far, we do not expect to see kind of a major inflection to happen all of a sudden. As you know, compounders have shifted now to personalization, basically combining, again, incretins with other molecules or other vitamins. We are taking action legally as well.
It takes time for the FDA to enforce the removal of those compounders. We are not assuming a major increase to take place anytime soon. We are very pleased with the projections on the growth that we have seen. Another data point I think is worth to share at this time. You have seen that we announced several agreements with compounders or telehealth services that were compounding products as well, including Ro that we signed last December. How we construct our agreements is that we are enforcing in those agreements that as long as the product is out of the shortage list, those telehealth services are not compounding either through Sempetide or Semaglutide. Right? It is also another way to move those out and move into the original brands. That is just to give you a little bit more color on that.
Maybe the last dynamic in terms of, again, modeling for the rest of the year, how the class will continue to progress, it's worth to note that there is seasonality. We've seen that in the last year. In type 2 diabetes, we've seen it for many years. There is more growth acceleration in the first part of the year, start to slow down in the second part of the year, continue to grow, but not at the same pace. That's what we have modeled as well for our projections for the second part of this year.
Maybe just going back to the CVS formulary effect, any quick.
I can comment on that. Thank you for reminding me about that. In the case of CVS, I've been open to share that, again, roughly the template formulary that it has been moving to one-of-one is roughly 200,000 TRx. What we have assumed on that is, again, that is going to be starting on July 1. As you can imagine, with all the moves that happen with payers, it takes time to implement. Also, there is a medical exception process that patients can go through and get that exception in place. Do not expect that will be all of a sudden 100% of those TRx moving into the competition brand. It will take time to see that happening. That is kind of what we are modeling our projections as well.
Okay. Let's shift to the international launches.
Yeah, happy to talk about it.
Maybe, Lucas, just remind us high level, what does your guidance assume in terms of international uptake over the course of the year? Maybe just give us some color on how these international launches are progressing. I mean, I read somewhere last week that the Mounjaro in India is just flying off the shelves. Maybe just kind of give us some high-level framing around that.
Yeah. Happy to talk about international business. The launch sequence is progressing within the plans that we put in place. We're sharing Q1 that now Zepbound, well, Mounjaro, because we have only one brand for US, is present in about 40 countries. If you go back maybe to Q3 last year, we were talking about a dozen countries. Quite a lot of ramp-up of countries that we launched both in Q4 and the first quarter of this year, and very in line with our expectations. We talk about some of the large countries that we launched as well. We were openly talking about China, India, and Mexico. Large patient populations, high unmet need that we just recently launched into those markets.
The progression of its early days, but we see very nice uptake similar to what we've seen in the U.S., which has in a couple of quarters in most of these markets becoming market leader. The market, what is more important in these markets, given the low penetration of the class, is to expand the market. We continue to see very nice, again, uptake on how much the class is growing, but it's early days at this time. Maybe the last data point you mentioned about this article about India, when you go and look at the details, that was the second month of the product into the market and comparing versus the first month, and we launched in the middle of the month. That comparison month to month, I don't think that is a good proxy to use.
We are pleased with the launch uptake as well that we've seen in India.
I guess just going back to the pricing question on the international side, you have oral generics hitting several international markets, I believe, starting next year or the year after that. How do you see that impacting the pricing strategy for the Tirzepatide complex globally overall?
Yeah. Maybe one thing that is worth to note as well on the international markets, because I focus my comments more on the obesity space, the other part going to your question about SEMA, we are also going through the process of getting reimbursement in type 2 diabetes as well. That takes time in all the markets to get that reimbursement. Usually, the first countries take six months, and it goes all the way to two years. We are going through the process of getting reimbursement for Mounjaro in type 2 diabetes. We are operating in Germany, Japan, U.K., Italy, and the Netherlands. Those are usually the first ones to go. We feel good about the launch sequence on those markets as well. Price concessions in part of all U.S. markets when you go through the reimbursement is very natural, and that has been factoring our assumptions.
Like with all the generics, again, that takes place as well in part of our assumptions when we think about the modeling on our projections or U.S. Given the differentiation on the value proposition, we feel strongly about what we are bringing to the market and our ability to separate from the generics as well. The channels, in particular, in many markets or U.S. as well, how the generics are being managed versus the originals is different, right? For example, in China, you go through, for example, all the originals go through a national reimbursement process called NRDL. The generics go through a tender process called BBP, right? Those are very different channels, and they manage different pricing separate and apart from each other. We feel good about our ability to continue to separate and maximize the opportunity for the originals as well or U.S.
I guess just hearing you speak, Lucas, just in terms of what you're observing across the incretin market right now, is it fair to say it's generally consistent with your expectations when you set revenue guidance this year?
Yeah, it is very consistent with our expectations. We put the bar high, as always. You see that playing out in the results that we are seeing after starting commercialization back in fourth quarter. We feel very good about the uptake that we've seen for both Mounjaro and Zepbound, and also the class penetration that we are seeing nowadays. Very much consistent with our guide.
Take a pause. Definitely questions from the audience before moving on. Okay, let's maybe talk about BD, Lucas. So just maybe starting with this cameras deal you did last week, tell us a little bit about this drug delivery technology and just the strategy here in the context of your views and how market dynamics are unfolding in terms of optimal dosing schedules.
Do you want to comment on this one?
Sure. I can speak to the specific transaction, and then I can talk a bit more about broader BD. We have a large number of investments across different targets that are pursuing cardiometabolic health. Some of those are looking at, like I said, novel targets. Some of them are looking at less frequent dosing. This transaction adds the potential to move some of our medicines to potentially monthly dosing, which is part of the cover every square on the obesity development landscape strategy that we have in place. It is a nice addition. As we think about less frequent dosing, it may have a little more applicability in a maintenance setting, because as you are starting up on a medicine, having the ability to intervene if there is something that you want to modify, it may be more beneficial to have a weekly dose.
A nice sort of small transaction to help round out the early phase portfolio.
I guess is this strategy of Duckens, you did another deal recently with SiteOne to expand your pain portfolio. Are these the types of deals that we should continue to expect? I mean, you're generating just a tremendous amount of cash. Is there any appetite at all to go larger?
Yeah. Again, both you mentioned SiteOne, we did a Scorpion as well in the first quarter in oncology, very nice asset, a PI3K alpha inhibitor. Those are very much within our strategy, right, that we see that we can add value. We bring them early on. We put on our R&D engine and accelerate their development as well. It is our strategy and very much within our core therapeutic areas. Thinking about large deals, we look at all the options always, but it is hard to see how we can add value. When you look at the business cases, usually on many of the large deals, you are bringing revenue products in the market. Given the growth trajectory that we are experiencing nowadays, most of those are actually dilutive to our growth. It is hard to make that work as well.
The value, of course, as well, when you look at it, is not actually adding value for the organization. We feel strongly about the strategy that we have in place to bring early phase. We will remain disciplined on that, but it doesn't mean that we are not looking at everything.
There's been a lot of excitement, certainly in the oncology world about these PD-L1/ VEGF bispecifics. Any updated thoughts on your level of interest in potentially participating in that opportunity?
Mike was the CFO in oncology, so he can comment more on the oncology assets as well.
No, I mean, it's certainly a closely, but we look broadly across all different targets. And we've been pretty active in oncology over the last couple of years, whether that's, like Lucas mentioned, the Scorpion transaction, or we added a radioligand therapy platform. We added some antibody drug conjugates throughout the course of the last 12 to 18 months, and those are all progressing quite nicely. So expect us to continue to be active and inciting the landscape.
Let's maybe talk about the cost base and just, I guess, just in the context of on the tariff front, I guess you've made some significant R&D and CapEx investments. Just high level, do these influence spend in other areas or require any rethinking of the expense? Any updated thoughts on margins broadly?
Yeah, that's a good question. We've seen other companies announcing restructuring and making adjustment on their cost basis. We feel strongly on the position that we are nowadays. Again, when you think about the last two, three years, the company has been basically growing at a fast pace. Just last year, almost five, six times the average of the growth of the industry, right? We are bringing new products to the market. We are investing to fully maximize the launches and continue to advance our pipeline across the board. It doesn't mean that we are not doing that with discipline and continue to expand the margins. Just looking at the first quarter of the year, comparing versus the same quarter last year, we expanded 11 percentage points on our up margin. Significant expansion that we continue to see. We are investing to maximize the opportunity.
Are we being disciplined? Yes. Just to give you a few examples in SG&A, all the investment that you're seeing and the growth, I think in the mid-20s in investment in SG&A growth versus the same quarter last year is mainly on variable. The fixed cost, what we call, again, commercial footprint and so on, we leverage the platform that we have globally to drive basically the launches globally as well. We are not adding more sales force. Very pleased as well on the progress on the gross margin, because also the new sites are more efficient, and we're running the lines at full speed as well. You see progress as well, gross margin getting into the 82-83%. Very nice progress. If you compare with any other peers, we are very competitive both in SG&A and gross margin. R&D, we are intentional, right?
We are more on the high end, but it's also part of our BD strategy that we bring assets early on. That brings also the burning in the cost in the R&D as well, because we put all of those assets in our R&D engine. It has played out really well. How we look at the productivity from R&D, they evaluated to this many times. I've been part of this journey as well, is thinking about future value of the pipeline comparing to the investment that we are doing. We are well above all the industry peers, even without the incretins as well. Thinking about the speed of bringing molecules to the market, we are doing that at really super fast pace comparing with the average of the industry as well. That's how we measure the productivity of our R&D engine.
Okay. I will move away from the incretin portfolio and get to the non-incretin portfolio, I promise. I just want to touch really quickly on some of the key upcoming events that are top of mind for investors. Mike, maybe ADA is coming up. You guys are hosting something next Sunday night. Maybe talk to us about what Lilly is presenting, what we should be expecting.
Sure. So three ADA sponsored symposia for Lilly at ADA upcoming. First is the AchieveOne Orforglipron phase III trial. So the first phase III trial that we top lined recently. We put a lot of data in that press release, so efficacy, safety, tolerability. Should not expect any major surprises from the presentation, but it is an important milestone for an important program for us at Lilly to have the full detailed data disclosed. The second would be some phase III updates, a detailed data readout for our weekly basal insulin. The third symposia is what we consider really the initial proof of concept data set for Bimagrumab. It is a combination with semaglutide. It is an IV administered formulation. First peek to what that looks like. The key data sets we are looking towards are actually the combinations with Tirzepatide, which will read out in the future.
We also do have a phase I presentation for our selective amylin agent, Eloralintide. There'll be a small section there as well. We plan to do highlights across the whole portfolio on Sunday night with an investor event. Quick plug for that as well.
And then SURPASS- CVOT. That's a trial that seems to be getting a little bit more mindshare. I guess the primary completion date is June 2025 per clinicaltrials.gov. Any update on timing there? I think higher level, while that trial is powered to achieve superiority versus Trulicity, you frame non-inferiority at the baseline. Why would that not create payer access coverage risk for the Tirzepatide complex if it only achieves non-inferiority?
Sure. Timing on track for Q3. Look for that data to come in the months to come. In terms of the study, we set it up against a strong agent that has a CV benefit. It is a head-to-head versus Trulicity. Non-inferiority for us is the path that we set as our base case. The goal is just to get enough data to get a labeled claim, an indication for a CV benefit added to Tirzepatide. Non-inferiority gets that. Trulicity is a really good agent that has strong data from the REWIND study in both primary and secondary prevention. In terms of how we think about it, right now, Tirzepatide has really broad payer access in Mounjaro. It is 90% plus. You have really strong usage in the diabetes setting. It is a market leader by new prescriptions.
That is without any CV data in the label. When you then add in what we hope will be a non-inferior study that adds the CV indication, that can be nothing but positive data for both the payer and the prescriber discussion. Now, taking a step back, that being said, as we look at when you have seen these data sets added to existing agents, when Trulicity got its REWIND in the label, when some of the competitive data sets have been added to other labels, we do not really see a meaningful change in prescription habits. Our expectation would be non-inferiority or superiority. We do not see that as a major event in terms of prescriptions. I know an important event that people are tracking. It is proximate, but it is something that we are looking forward to having the data read out, and we will be continuing from there.
Helpful. Thank you for that. And then just last on Orforglipron, just any updated thoughts on ATTAIN -1 framing that's also coming up? And I think you've previously referenced SURMOUNT-5, which was the GLP-1 injectable monotherapy trial that showed about 13.7% weight loss.
Yeah. I'll
go ahead, Lucas.
Yeah.
You mentioned ATTAIN-1, but we have pretty much every single quarter data readouts of Orforglipron coming, right? ATTAIN-1, it gets a lot of attention. That is the obesity study. We have ATTAIN-2 that is for obesity and patients with type 2 diabetes. And then we have several studies on type 2 diabetes as well that will read out in Q3 and Q4. I think it's ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 as well that will read out in the second part of this year. So quite a lot of momentum on data readouts that will happen with Orforglipron. Going back to ATTAIN-1 that is getting all the attention, yes, we're referencing to SURMOUNT-5. That is our study that we compare to subcutaneous injectable semaglutide.
Our expectations that we have been highlighting as well, both in type 2 diabetes and obesities, are to be similar to injectable sema, right? We have been successful on that in type 2 diabetes. We feel good about, again, what is coming now on Orforglipron, though we do not have visibility at this time. We referenced that data point that it was in the double-digit range. It was 13% that we have seen on sema in terms of weight reduction. I think when you think about this type of asset that you bring on a small molecule, the differentiation on this one will be less about, again, how much weight loss. I think there is, again, a large patient population. If you want higher weight loss, getting into that more high teens or into the 20% range, you have Tirzepatide.
The benefit of this drug is to have an option that is a small molecule oral daily. That is the differentiation that it has no restriction on intake as well. That is the differentiation. There is a large patient population that requires this level of weight reduction. We see a large opportunity both in the U.S. and also OUS as well.
Okay. We've got about five minutes for the non-incretin portfolio. Let's try and do a bit of a rapid fire here. I guess starting with neurology, there's a lot of interest, particularly as Trailblazer comes into focus. Maybe just frame Lilly's approach high level and then maybe double-click on where we are with the Kisunla launch. What are the key readouts to watch? Timing, just how are things going on that side?
Yeah. I can share even a little bit of my own experience. I've been on the field visiting both diagnostic centers and also Kisunla prescribers. Again, modest initial uptake that we've seen, but very much in line with our expectations. We share very openly that it will require quite some time to develop the ecosystem from detection, diagnosis, to actually treatment to take in place. We are pleased with the uptake that we are seeing. 40% of new prescriptions are going to Kisunla, knowing that we launched behind Leqembi as well. It's growing that. Very initial positive uptake and feedback from physicians that we are seeing. Nowadays, Kisunla is available in all infusion centers, broadly covered as well in the U.S. It's off to a good start, but it will take time to continue to develop the ecosystem.
The other, again, data readout that it gets a lot of attention is TB3 that is in preclinical for Alzheimer. That study is fully enrolled and is completing by the second half of 2027, but it's an event-driven study. Could read out sooner than by the end of 2027. Why is that also important, that study? When you think about preclinical population, you're thinking about patients that have the pathology of amyloid already, but they have no symptoms or cognitive decline. It's a larger patient population as well. Also, the benefit is the study is designed to be actually diagnosed with a blood biomarker, right? That is more convenient and more broadly used as well. That could unlock or maybe remove one of the barriers that we see nowadays that is the diagnostics, sorry. That could unlock a significant opportunity as well. More to come.
As I said, again, we are developing the ecosystem. Initial projections are very much in line with our expectations.
Maybe shifting to immunology, Ebglyss had some very encouraging US uptake in atopic derm. New patient starts are increasing. Seems like you made pretty good progress on access and reimbursement. Maybe just any updated framing on that.
Yeah. Happy to share. As a reference, we launched Ebglyss in September. We started commercialization in October. Hopefully, you are seeing some of the commercialization efforts. We have our DTC campaign out there on linear TV as well since Q1. Early days, but very positive feedback. In particular, in terms of the access, we already secure all major PBMs for the second part of this year. Broad access similar to the competitor in the marketplace. It is off to a great start. We see this adding more optionality for physicians on how they think about their treatment as well. Very promising future ahead for Ebglyss.
Maybe just in the minute that's left, can we just talk about the Lilly Direct sort of strategy? What's the strategy here high level? I mean, initially, it seemed like it was, I mean, it seems like you're expanding it now into other areas. How are you thinking about this strategically over the longer term? Is there an effort here to maybe think about potentially at some point moving out from eliminating the middleman and going?
Yeah. Just as a reference, Lilly Direct is a digital online pharmacy that we put in place two years ago, almost three years ago. It started with insulins and the migraine portfolio Emgality. We added, again, last year our incretins as well, more on the obesity space. We have Zepbound vials out of pocket as well that we ship directly to the patients. We talked already about the Zepbound vial progression that is, again, getting a lot of momentum. We continue to improve the customer experience of this Lilly Direct solution and direct to the patients. We also offer, again, telehealth services or in-person services. Those are all independent, but they are offered over there. On those services, we also added Alzheimer as well very recently that it was announced as being an infused product.
Of course, we do not ship the product, but again, we offer, again, the services of telehealth as well. Helping to also unlock one of the restrictions that we are seeing that is the referral from GPs into neurologists that is taking so long as well. This could also unlock some opportunities in the future. Very pleased with the progress that we are seeing. It is still early days on Lilly Direct. Thinking about, again, Zepbound, we always talk about this as a, I call it as a hedge as we continue to grow access, right?
Again, while access continues to ramp up, expect, again, that will have an impact as well into Lilly Direct in my eyes because you think about patients that now can get access or the product basically fully cover or partially cover, they will always go for that access option versus the out-of-pocket option. Think about that as a kind of a bridge solution until we continue to ramp up access.
Okay. All right. We are just about out of time. Thank you, Lucas. Thank you, Mike.
Thank you for having me.