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

May 24, 2022

New York Stock Exchange US Health Care Pharmaceuticals conference_presentation 39 min

Earnings Call Speaker Segments

Colin Bristow

analyst
#1

Well, good morning, everyone, and welcome to day 2 of the UBS Global Healthcare Conference. I'm Colin Bristow, one of the biotech pharma analysts here at UBS. It is my pleasure to have with me today, Mike Mason, President of Lilly Diabetes. If anyone has a question, there's QR codes scattered around. And if you -- you can then submit it electronically, and it will magically appear up here on the iPad. Mike, we've talked a lot. I know you have a lot to talk about. So I'll hand it over to you for some opening remarks, and we'll dig into some questions.

Michael Mason

executive
#2

All right. Sounds good. Thanks, Colin. Thanks, everyone, online and in person. I like the setting. I feel like I'm back in the '70s, but this is great. But I -- no, I appreciate the interest in Lilly Diabetes. It's a fantastic time for us. We have a full pipeline of leading products. First, I'll touch on Jardiance. We have a phenomenal alliance with Boehringer Ingelheim, just great partners. Very successful long-term alliance right now focused around making Jardiance a product that not only treats type 2 diabetes but a cardiovascular product that helps heart failure as well as potential for CKD. So we've seen a -- we've launched both heart failure for HFrEF and HFpEF. And with those launches, we've seen our new treatment share market go above 64%, which is very encouraging. We've seen the market go close to 30% year-on-year growth on average. So we're very pleased about the growth trajectory of Jardiance as well as Trulicity. It just has a phenomenal position in the marketplace and going quite well for us. And then we're blessed to have the opportunity with tirzepatide. We got approval recently for Mounjaro for type 2 diabetes, and I think everyone has seen the SURMOUNT-1 data, which showed for the people who live with obesity, don't have type 2 diabetes, weight loss up to 52 pounds in our 72-week study. So it's a great time to be here. Great time to be leading Lilly Diabetes.

Colin Bristow

analyst
#3

Fantastic. So maybe let's start with Mounjaro. Obviously, very [indiscernible]. Congrats on the approval. Can you walk us through the launch strategy? Like what are the patient buckets you're primarily targeting? There's been a lot of discussion around the GLP-1 Trulicity potential switches. Can you address that?

Michael Mason

executive
#4

Yes, it's a good question. I mean we don't go too much through our strategies because we're getting ready to launch and haven't exposed that to our competitors or for the customers just yet. But if you look at the profile, obviously, Mounjaro really helps people get in better control as well as helps them lose a significant amount of weight. And so when you look at the individuals who live with type 2 diabetes, those are benefits that a lot of them can benefit from. So as we do our market research, we have a really high degree of interest, both from health care professionals, payers and consumers. So our strategy is really to be targeting those individuals who can most benefit. Typically, those are patients who are out of control and whether those be kind of new to class or within that class, and that physician has to make a treatment decision. So I think it's always better for us to focus on establishing a product long term and really meeting the needs of health care professionals and consumers head on versus trying to worry about switching Trulicity versus tirzepatide. So our focus is establishing the product in a really strong position for the long term.

Colin Bristow

analyst
#5

And let's just discuss pricing. So it came in at a price point around -- I think it's 9.9% above Trulicity, other GLPs. Walk us through the rationale about how you arrived at that price point. There's been a lot of discussion about what the read-through means to how you're positioning yourself competitively in obesity. So tell us what you can.

Michael Mason

executive
#6

Yes, I can. Yes, I won't go into obesity pricing. We've got a little bit of time to complete that evaluation. We have options. So we'll make the right long-term decision. So the 9.9%, I'll talk about it in relative terms to type 2 diabetes. When we take -- we were able to do a head-to-head study versus semaglutide that showed superiority on A1c and weight loss. And we do a lot of healthy kind of modeling, and we thought that, that price point was a good balance because you want to make sure that you're able to get value for the investment that you put into a new medication that showed that much promise, but also you want to make sure that you're able to get broad access and help as many patients as possible. So we think that's a -- it's a really good price point for us that we were able to benefit from our investment, but also we believe we can get broad access at that price point.

Colin Bristow

analyst
#7

Anything you can say about the choice to do flat pricing versus differential dosing?

Michael Mason

executive
#8

Yes. I mean we evaluated differential dosing. We evaluated flat pricing. We think flat pricing is the easiest approach for payers and health care professionals and consumers. If you get too aggressive and try to price the higher strengths too high, you can run the risk of them not having the same amount of access as your lower doses. The lower doses are very efficacious. So we think it's better to have flat pricing that enables health care professional, consumer to really use a dose that best helps them.

Colin Bristow

analyst
#9

Just from a timing standpoint, when you've got approval, obviously, there's sort of -- there's cycles to get on formularies, et cetera. Do you think this adequately positions you to get on the majority of formularies next year?

Michael Mason

executive
#10

Yes. We've already started our dialogue with payers. They're aware of our list price, and we think we can get broad access at this price point. Our conversations are going very productive at this point.

Colin Bristow

analyst
#11

And then clearly, with a product with this much interest from the investors' side, there's going to be a lot of focus on the launch. Can you walk us through what we should expect from the first few quarters in launch in terms of discounting, rebating, sampling? Give us some color there.

Michael Mason

executive
#12

Yes, it's a good question. So our focus is to establish this product for long term. And so we want to make sure we -- we're not focused -- having success in the first 3 to 6 months, that doesn't attribute itself for success long term. So our focus will be, first of all, making sure that we can build good access at the right price point. So we won't be too aggressive. I mean we could have access probably right now for every payer who are willing to pay the steep access in order -- or rebates in order to get that. We'll have discipline there. We'll make sure that we get the access at the right time cluster-by-cluster basis. In the meantime, we will be supporting patients that those early experiences that a physician has is really important. If patients are able to get access to it, we're able to have a good start on a medication. That just wonderfully supports your position in the marketplace. So we'll really focus on setting patients up for success. We'll have a bridging program until we get access, so they can get access. We'll have a $25 co-pay card, so people can get access at affordable price. We're going to be providing a month-long samples at 2.5 milligram dose so that patients can experience the product for a month at 2.5 and then they're going to make that transition from 2.5 to 5, very simple, where a physician, if they use samples, can give a month's sample pack and then write a prescription for 5 milligram. We think that's the right way to start a patient. Now that may delay scripts a little bit in the first month if someone's working through their samples versus going to get a prescription. But we think that's the right approach long term.

Colin Bristow

analyst
#13

As we think about what you've learned from the Trulicity launch in terms of where patients discontinue, where they need sort of assistance with compliance, what can you tell us there? And how are those learnings being factored into the tirzepatide launch?

Michael Mason

executive
#14

Yes. We've built a group in 2013, when I was leading the U.S. Diabetes team, to really focus on that all-important first 60 days. So we've mapped out the first 60 days kind of journey that someone who lives with type 2 diabetes who's starting on incretin experiences, and then we try to meet them at every point in that journey and give them exactly what they need at that point in order to go on therapy. So that group we've gone through pilot interventions. All the ones that are successful, scaled those up. That group lives today with the same leader that we've built upon in 2013. So all those learnings that we have on Trulicity will apply directly to tirzepatide. We've been really proud of what we've been able to do. It really -- our focus is we know that if we can set patients up for success. That's the right mission that we need to be on at Lilly Diabetes to help patients get better outcomes. And it's the right approach to establish a new brand because it's what those customers come back and tell the health care professional which matters so much.

Colin Bristow

analyst
#15

We sort of touched upon GLP-1 or current GLP-1 switches. There seems like an inevitable portion of Trulicity cannibalization here. How are you thinking about that right now? It sounds like it's going to be a naive patient targeted campaign but just what's your expectation there?

Michael Mason

executive
#16

Yes. I was -- earlier in my career, we had a -- we launched a product that was a more of a kind of end-of-life cycle play, and we were trying to switch patients from our current marketed product on to a new product. And that was a good learning for us. If you're -- if you go out there to health care professionals and you're really focused on switching and that's kind of your business goal, you won't win in the marketplace. They see through that. I think the best thing to do is really focus on what patient types that are appropriate for your new product, sell them and then let kind of osmosis happen. And so what we'll do is we'll establish this. There's a lot of patients who need the profile and the benefits of what tirzepatide can offer, Mounjaro can offer. And we'll sell those benefits. And then naturally, we'll win new patients into the class. And there will be some physicians who [ were to win ] on Trulicity or were to win on semaglutide. And naturally, there may be some patients who may be on Trulicity, who need more efficacy, either A1c or weight loss associated with type 2 diabetes, and doctor may decide to put those on Mounjaro. But our focus is really going to be establishing Mounjaro in the type 2 diabetes for the long term versus just purely a switching focus.

Colin Bristow

analyst
#17

Does that -- does the incentive to switch grow at all as we approach the Trulicity loss of exclusivity?

Michael Mason

executive
#18

Well, see, I mean I think long-term value is generated by how the market does and how our Lilly share of market goes within the endocrine market. So our focus will be on there. We have many years before we go into end-of-life cycle. So we'll still have time to evaluate that and see whether we need to do any specific tactics at that point. But our focus long term is growing the class, growing our share within the market.

Colin Bristow

analyst
#19

Do you -- one question we've had a little bit is just the anticipated off-label use. You've shown amazing obesity data, obviously. Any comment on any data you have with regards to the off-label use of competitors' products for obesity? And where would you expect yours to shake out prior to an official obesity approval?

Michael Mason

executive
#20

Yes. I'm going to officially state that we won't do anything to drive off-label promotion. So our focus will be purely on type 2 diabetes and not obesity until we get that indication. It's probably a better question for Novo than for Lilly. I think it's an unusual situation, and it's probably hard to project what happened to Ozempic and Wegovy and directly take that over to Mounjaro. I mean it's a unique situation where you have a product launch for obesity, and then they have supply issues when you have a product with the same active ingredient for type 2 diabetes. So there's some -- obviously some unusual situations there. So we'll see how it plays out after they get through their supply issues.

Colin Bristow

analyst
#21

Again, clearly incredible SURMOUNT data. And so I think your base case expectation was for a filing in '24 on the basis of the complete program?

Michael Mason

executive
#22

Yes.

Colin Bristow

analyst
#23

One, can you walk us through the program? So what are the subsequent readouts we should expect? And then -- and two, what are the steps that you're going to take now to try and accelerate that?

Michael Mason

executive
#24

Yes. So we have -- when we agreed to the FDA on our Phase III program for obesity indication, it was done in a vacuum of just what do you need in order to get a chronic weight management indication. And we have 4 trials in that program. SURMOUNT-1 was the first. It was the largest -- the whole program is about 5,000 patients. About half of those come in SURMOUNT-1. And then we have SURMOUNT-2, 3 and 4, which are all around 500 to 900 patients, and they will read out next year. And so kind of looking on that time line for launch some time in '24. The SURMOUNT-2 program is actually testing tirzepatide in patients who have type 2 diabetes and obesity. So obviously, we have a lot of data on -- in our SURPASS program for individuals who live with obesity and type 2 diabetes. So that gives us an opportunity, we believe, to go to the FDA, share with them the SURMOUNT-1 data. And we have just massive numbers of patients within our SURPASS program that live with obesity who have type 2 diabetes. So we think we have a significant data set, both in the efficacy as well as the safety and tolerability that would allow us to have a good conversation with the FDA to say, given the unmet need, given the terrific results of SURMOUNT-1, here's an opportunity for us to accelerate approval. So we'll have that conversation. We'll see where that goes.

Colin Bristow

analyst
#25

Any -- can you give us any time lines around when that's likely to occur? Or when you would likely to be in a position to update us?

Michael Mason

executive
#26

I would say in the second half of the year, we should have a better idea of whether we'll get an accelerated -- opportunity to accelerate the launch or whether we're on kind of the original time line.

Colin Bristow

analyst
#27

Super. We have a couple of questions here. So Victoza is hanging around, which suggests switching patients isn't easy. What can Lilly do that Novo could not?

Michael Mason

executive
#28

Yes, it's a good question. I mean if someone is doing well on a product, it's not in any one's best interest to switch them. So we would never target a patient who is doing well, who is meeting their end goals. We also -- what you typically see is it's really at times physician-driven that you can have physicians that really like the older medications because they're tried and proved and that -- and so it's really about having different physicians along the continuum of adoption of products. And so it comes down to targeting and getting the physicians where they're at. There might be perceptions that a product like Victoza could have better access because it's been on the market longer. If that's the case, that's a -- I think is not a correct assumption by physicians and one that we can break through promotion. And so Novo is a good -- an excellent diabetes company, we are, too. So I think it's a matter of just meeting the physicians where they're at and ensuring that they have someone that is on Victoza, who is out of control, what's the best option for them. Some of those individuals could be on Victoza and have moved to -- in combination with the basal insulin, and it's that basal insulin that's really provided the efficacy at that point.

Colin Bristow

analyst
#29

What has -- I mean it's super early, but what has the early frontline feedback been from physicians who have the approval, have the label? We have the SURMOUNT data. It's a powerful pitch.

Michael Mason

executive
#30

Yes, it is powerful. The best thing about launching a product is going into market research, presenting the profile to health care professionals and payers and consumers and seeing their reaction. And it's always a good sign when, at the end of market research, if you're -- the physician or the person who lives with diabetes says, is this on the market? How can I get it? When is it launching? And that's what we heard just about in every market research interview. The physicians are wanting this, consumers are wanting this. So we've gotten just a marvelous reaction to our product.

Colin Bristow

analyst
#31

And another question here. Novo has CagriSema in their pipeline with a target weight loss of 25%. What are your thoughts?

Michael Mason

executive
#32

We all have products in our pipelines. We target 25% or 30% or even higher. It's great to have a product like tirzepatide. It's great for science. It's great for patients who live with obesity because it sets a really good benchmark for every other product to succeed. So what's nice is we have a full pipeline of agents, but the bar is we've got to do significantly better than what tirzepatide did. And that drives us and pushes us to be more innovative, find new ways to get that done. So do I think the tirzepatide will end up having the best weight loss of any product in the next 20 years? Likely not. But I think both Novo and Lilly will continue to iterate and provide even better products out there. But in the meantime, we're very excited about the opportunity ahead of us with tirzepatide.

Colin Bristow

analyst
#33

And just remind us. I think you have the GGG product. Just give us the -- what you can quickly say about that?

Michael Mason

executive
#34

Yes. So there's 3 incretin hormones. There's GLP, GIP and glucagon. So Trulicity is just the GLP. Tirzepatide adds a GIP to a GLP, and then GGG has all 3 components, including glucagon. We think glucagon can do more for energy expenditure and should give us a greater weight loss versus tirzepatide. We're studying it in the Phase II clinical trials right now for obesity and diabetes, and we'll get those data and then make a decision on whether to go to Phase III.

Colin Bristow

analyst
#35

Another question from the audience. Novo's weekly insulin shared some interesting data with good glucose control and some hypo-risk. Could this protect the basal insulin market? Or is this a market subject to pressure no matter what?

Michael Mason

executive
#36

I think it's a good opportunity to win share within the market. There will be -- we'll see how the agents do in efficacy. I think you need to demonstrate better efficacy to get better pricing in the basal insulin marketplace. So that's what both Novo and Lilly are trying to do in our Phase III clinical trials. And only time will tell whether we'll be able to achieve that. But it's a much better customer experience than a daily insulin. And so if anything, I think it will help us maintain, win share in the marketplace. When you look at our U.S. share of the basal market, it's only 16%. So I think this gives us an opportunity to be more competitive in that segment.

Colin Bristow

analyst
#37

And another question from the audience. You've obviously had great data recently. But even when you don't have a best-in-class product, Lilly seems to have an ability to make a commercial success of it. In your experience, what is the Lilly secret sauce?

Michael Mason

executive
#38

The Lilly secret sauce, okay. We have great people who care a lot about people who live with diabetes. And our focus, we live on a daily basis to make sure that we pay -- we've set patients up for success. We only promote for those patients who can benefit from our products. And then we're really focused on making sure they have a good outcome. If they have a good outcome, then they win. Really it sets a great perception on the product with physicians because we can be proud of -- and think a lot about our promotion when our sales professionals go in and talk to a physician about our product, but they may see one of our reps twice a month. They could see 5 patients a day who live with diabetes. And it's those experiences that they hear from the people who live with diabetes that they treat on your product that means much more. So our focus is making sure that we establish a great experience, and we set people up for success, so they come back and kind of reinforce how good our product is. And then we just have -- we have an ongoing transformation across our commercial organization, across our sales channel, across payer, across affordability, across our experiences that consumers have as well as direct consumer advertising that has continued to evolve since we launched Trulicity. And so I was driving to work a week or 2 ago and really just assessing kind of where we are with tirzepatide versus where we were with Trulicity back when we launched that in 2014. And in every aspect of our launch, we have transformed and are so much better than what we were in 2014. So that gives us a lot of confidence as we go in to really -- we promote the Lilly way. We're very disciplined, very data-driven, and we're really excited to make a difference for patients living with type 2 diabetes.

Colin Bristow

analyst
#39

So just going back to that kind of Trulicity versus Mounjaro launch in terms of is there more horsepower behind the Mounjaro launch? Is there -- is it smarter, more sort of data-driven decision making? Is it both? Could you just elaborate a little?

Michael Mason

executive
#40

Yes, it's both. The market has evolved quite a bit, and so we will be putting much more horsepower around the launch than what we did at Trulicity. We were promoting to around 40,000 physicians for Trulicity at launch. We'll be promoting to around 100,000 physicians for tirzepatide. But also everything that we've learned over the last 8 years with Trulicity and have grown and developed and expanded, we are applying to tirzepatide. We've looked across not only everything we did with Trulicity but everything we did as a company and everything other companies have done to really establish a blockbuster. And in every aspect of that, we've advanced and, I think, more sophisticated than what we were before.

Colin Bristow

analyst
#41

Another question. I'm becoming increasingly worried about what people are going to have me ask, but one could argue that the insulin price declines have allowed the GLP-1 market to expand. If there isn't any oxygen generated somewhere, do you expect the payer environment to toughen with regards to GLP-1, especially if we see off-label use in obesity?

Michael Mason

executive
#42

Yes. I mean I think there will always be tension on the payer side. Do I think it's going to accelerate? No, I don't. I think there's good, healthy tension there that helps patients and helps payers. But we're proud of where -- how the market has developed, not only growing from a TRx but has grown from a revenue perspective. So we think good growth ahead for -- on both volume and revenue for GLP to still sustain ability to do that. At this time, we don't -- we haven't heard from payers that they want to restrict the class. I mean I think we -- there are opportunities for both Novo and Lilly and other GLPs to come in and have an open competition within -- at the consumer level and at the physician level. I think it's good to have choice in the marketplace. Not every product will be the best product for someone who lives with diabetes, and physicians and consumers should have options. And so I think that's important. And so there's always going to be pressure. Our pressure, while our net prices have gone down, has more been because of segment mix, because we're at the point in the life cycle for Trulicity where you're gaining access and use in lower-priced segments, government segments, Medicaid segments. And so it's more of that segment mix. These are profitable but not as profitable segments, and it brings down your net price.

Colin Bristow

analyst
#43

And just an overall question on pricing. You obviously have a marketed product in every sort of sub-class of diabetes.

Michael Mason

executive
#44

Yes. Yes.

Colin Bristow

analyst
#45

Any observations there that -- anything you're seeing that should suggest a different trajectory going forward to what we've observed in the past?

Michael Mason

executive
#46

On pricing?

Colin Bristow

analyst
#47

Yes.

Michael Mason

executive
#48

I think this year, the -- and it was baked into our guidance, so nothing different from guidance, but we did drop our Lispro insulin by 40% in January. So that will have some impact to accelerate probably our pricing. We didn't see that in Q1 results because of prior period adjustments, but you'll probably see that going forward and maybe a little bit higher price decline in mealtime insulins in 2022 because of that.

Colin Bristow

analyst
#49

Okay. And maybe just to move to obesity again. There's been some huge numbers thrown out about the market. We see this sort of 100 million patients in the U.S. What are you -- what is your data -- what are your sort of expectations around what is the truly addressable sort of treatment-seeking, compliant or meaningfully compliant patient population?

Michael Mason

executive
#50

Yes. I mean we believe that a large percentage of those will have an interest in the product. I think the main driver in the evolution of the obesity market will be access. So you need to unlock Part D coverage, that's with the Treat and Reduce Obesity Act they're trying to do. You also not only need to get access at the payers, but then employers got to opt into that coverage. And so that's the most important thing to develop the obesity market. I think both Novo and Lilly has a role in demonstrating no obesity product is showing outcomes associated with weight loss because, quite frankly, the weight loss wasn't great enough to show those outcomes. We believe with tirzepatide, we have the ability to lose up to 52 pounds at the highest dose, to really demonstrate good health outcomes. So that's why we're doing an outcome study in CV and a little bit broader. We're doing our sleep apnea study. We're doing heart failure because these are important opportunities. These are disease areas that payers, Part D already give access to. And so if we can demonstrate that for someone who lives with obesity, who has sleep apnea, who has heart failure, who has CV, that that will begin to unlock those segments and really no question that those individuals should be treated and should have access to a product like tirzepatide. So we really think we need to demonstrate that, and we'll demonstrate that over time, and that should unlock access. Those are very large segments. If you think of sleep apnea, 39 million Americans live with sleep apnea, who doesn't have diabetes. And that's a massive opportunity. Only about 9 million are treated right now or diagnosed, but we think the opportunity with a product like tirzepatide, that could expand. And so we think we have a real opportunity to unlock that because of just terrific weight loss that SURMOUNT-1 showed.

Colin Bristow

analyst
#51

You have some sleep apnea data coming soon, correct? Or it's on the horizon?

Michael Mason

executive
#52

It's on the horizon, yes. Yes.

Colin Bristow

analyst
#53

Can you sort of -- can you roughly sort of frame when? Or is it...

Michael Mason

executive
#54

I don't know what we've released. Yes, I don't think we've said exactly what the time line is.

Colin Bristow

analyst
#55

Okay. Just as we think about, again, sort of contrasting diabetes to obesity, what's your expectation around compliance rates in one market from the other? And how do you address that? Again, you have a system clearly in diabetes that is very efficient and set up to maintain the patients on therapy. So how would that differ in obesity?

Michael Mason

executive
#56

Yes. It's -- it will be fascinating to see how it works out. And they're 2 very different therapeutic areas. So with type 2 diabetes, you kind of have this continuum of care, people start on orals, generic orals and orals, move to GLP, move to injectable insulin. And that is really driven by kind of beta cell health. And so we do a lot, as I talked earlier, to make sure we set people up for success, to make sure they stay on therapy. But typically, beta cell health will decline. And if beta cell health declines too much, you're going to need to go on insulin. Now we hope with -- tirzepatide with the GIP component does improve insulin sensitivity. Insulin sensitivity can help preserve -- make the beta cell work not as hard, which we hope can maintain beta cell health. But in type 2 diabetes, you're going to have this phenomenon where at some point, you may need to go on insulin. Some physician may choose to add on insulin to a GLP. Some may choose to move them directly to insulin. And you don't really have that in obesity. We don't -- you don't have that same phenomenon with beta cell health. And so you won't have that kind of durability issue. But we do believe that there's going to be a lot of education that's needed that, let's say, I've lost weight, I'm near my goal weight, what -- how is someone living with obesity going to behave at that point? Are they going to assume that they have kind of -- they're cured? They're at their normal weight and they don't -- no longer be on the product? I think we're going to see that. We've seen that in, like, depression and other therapeutic areas where someone gets better. They don't necessarily want to be labeled with having a disease. They'll stop taking it. And all of our data would suggest that patient will stop -- will start gaining that weight back if you remove the drug. So I do think you'll probably see some off and on. It's typical within kind of the weight loss market right now for people to go on and off. We need to really turn this into more of a chronic disease, and that's what we're trying to do. So we'll have to fight that long term. We'll have support programs to support someone, both in the short term and the long term for obesity. But it's really important for us, patients need to stay on the product long term. We have a role to make sure people get good outcomes, and we'll be very focused on that.

Colin Bristow

analyst
#57

Great. A couple of more questions here. Any thoughts on indications like NASH, and within that, the sort of diagnosis and access to patients?

Michael Mason

executive
#58

For NASH, yes, we have a Phase II clinical trial for NASH right now. We'll get those results and we'll evaluate what opportunity we have within NASH. I think what you'll see quite a bit with a product like tirzepatide, if someone has liver fat, that tirzepatide should relieve and reduce that liver fat. So I think upscale, upstream of NASH, we think there's an opportunity for us to help out and help relieve some of the burden on the liver by reducing the percent of liver fat that they have. So we think we have an opportunity there to make a difference. Whether we choose to do that through kind of fibrosis improvement with NASH, time will tell.

Colin Bristow

analyst
#59

Another question here. Does it surprise you that it's taken this long for the benefits of the SGLT2 class to catch on with people?

Michael Mason

executive
#60

I would say, the class has grown quite a bit. I mean it's -- by volume, it's like top 5 primary care products globally. So let's say, it's catching on quite well. It -- the EMPA-REG data has -- really was the estimate for growth of the market. We believe there's ample opportunity for growth with heart failure. We're starting to see that as many new patients are started on Jardiance in a month by cardiologists as we see on with endocrinologists. So that's a great opportunity of really tapping into this as a cardiovascular product for heart failure. And then CKD, we had an interim stop point there. The product was -- the trial was stopped because of overwhelming positive efficacy. We haven't seen the data yet, but we're excited to see that data. That's a big opportunity. About 30 million people live with CKD, about 1/3 of them have diabetes. So I think it's a good opportunity to further expand outside of diabetes in a patient population that has great need, great economic benefit. So I think really bullish on the SGLT2 market. It's great to see that it's growing in a higher 20%. It did take a few years for it to -- it seemed like it was stuck in the low teens for several years longer than we expected it. But I think right now, it's on a growth trajectory that will continue for quite a long time.

Colin Bristow

analyst
#61

The lean body mass loss data for tirzepatide, when should we expect to see that?

Michael Mason

executive
#62

I think more to come on that. I can't remember whether that's in our ADA Symposium or not, but probably a good reason for people to tune in a week from Saturday on that.

Colin Bristow

analyst
#63

Anything -- any sort of -- maybe just refresh us what's coming at ADA? And what -- if you were in our seat, what you'd be paying attention to?

Michael Mason

executive
#64

Obviously, the SURMOUNT-1 data release is exciting for us, and I think it is the key data release for us at the ADA. And so that would be the one on Saturday morning to watch for.

Colin Bristow

analyst
#65

And then just with regards to tirzepatide approval, ex U.S. Can you just walk us through those time lines? And then as you think about commercialization in those different markets, any additional challenges or things that you're specifically thinking about?

Michael Mason

executive
#66

Yes. We filed in Europe and Japan last year. So we expect approval in the second half of this year in those marketplaces. Those processes are going quite well. We have a history. We have a very disciplined launch-readiness process that's produced consistent results across U.S. and global markets. We're leveraging that same process that we used for Trulicity on tirzepatide. So we don't expect any surprises. We expect the markets behave -- there's a few iterations, but largely, they behave the same. And we have good capabilities to get consistent launches just through disciplined execution, disciplined adherence to strategy.

Colin Bristow

analyst
#67

Just one more question here. With regards to the Wegovy supply versus demand dynamic, there's obviously been a disconnect because of the supply. Like, do you have a sense of how big that delta is? And if it was -- if that wasn't a constraint, what -- how much larger do you think the numbers we'll be seeing?

Michael Mason

executive
#68

Yes. I think the real question is when the direct consumer advertising starts, I think that's -- you'll see a big inflection point at that point. So I think when Novo is able to get supply and meet that supply and feel confident enough that they can turn on direct consumer advertising, I think you'll probably see an inflection point in the market at that point.

Colin Bristow

analyst
#69

Fantastic. I think we're right at the end of time. So Mike, just I'll turn it back to you. Any sort of closing comments? You clearly have a few busy months ahead and are a popular guy. So I'll hand it back to you.

Michael Mason

executive
#70

Yes. We're -- it's an incredible time getting ready to launch what we think will be a transformative product that can disrupt the progression of type 2 diabetes in several weeks. It will -- actually, we'll start shipping it to pharmacies next week. And so that's an exciting time, as we're learning more about the obesity market and its tremendous need, both emotional and health needs for people who live with obesity. And it's very humbling to have a product like tirzepatide that can help 2 of the largest chronic diseases in the world. And we have opportunity, I think, to stop the progression of both of those diseases and can't wait to tackle that challenge. So I appreciate everyone's interest and questions today.

Colin Bristow

analyst
#71

Thank you for your time. This is great. Congrats.

Michael Mason

executive
#72

Thank you.

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