Okay, we're at the hour now. My name's Trung Huynh. I'm the U.S. Pharma Analyst here at UBS. Thank you everyone for joining in the room and also online. It's my pleasure today to host Eli Lilly. And we've got Patrik Jonsson, the President of Lilly Immunology. But upon Mike Mason's retirement, he's going to be his new title will be President of Lilly Diabetes and Obesity, as well as the President of Lilly USA. So welcome, Patrik.
Thank you so much, Trung.
We've got Lilly on a momentous day today, with the approval of Zepbound. So I appreciate there's gonna be a lot of interest in diabetes and the obesity space, but I will be touching later on in immunology, which is Patrik's current day job at the moment. But I think it would be wrong if I didn't start off with obesity and the approval today. We see in the press release, the price is 20% less than Wegovy. It's on par with Mounjaro today. It's a surprise to me that you've come in lower than a competitor. You don't often see that. Perhaps why can you... You know, why, why did you price it at this price point?
First and foremost, let me say, I think it's quite natural to start with questions on obesity today, having the approval of Zepbound. I think it's a game-changing day for people with obesity, and it's definitely a historic day for the efforts that we have been putting into R&D in this space. So the press release came out a couple of hours ago, and we announced a price of $1,059 for Zepbound, very close to Mounjaro. You know, I think we have been listening to the key players in this space for quite some time. Getting access for obesity is going to be very different compared to type 2 diabetes. So of course, we need to get the access through the PBMs, but we have also the employer opt-in.
I think currently, about 50 million patients that opted in through their employers for obesity treatments that are in the marketplace. I think we are aiming for more than that over time. But the only price that is visible to the employers are the list price. So that's just a signal from our side, that we are taking their feedback and their concern seriously. So that's why we're pricing it pretty much at parity with Mounjaro. So that's just taking into account the feedback we hear from employers and improving access and increasing employer opt-in. That's the rationale for the pricing we have decided to go for.
Perhaps can you talk about some of the coupon strategy that you also announced in the press release today?
I'm happy to do that as well. So I think we are offering, for covered patients, the $25 copay card. And for non-covered, I think we learned through the launch of Mounjaro in type 2 diabetes, that we offered a very generous patient assistance program for Mounjaro, which we actually terminated by the end of June this year. So what we're offering here for non-covered patients is $550 copay for non-covered patients for Zepbound.
Okay. And given this, and the price on par with Mounjaro, is it reasonable to expect the rebate to be in the same sort of range as it with Mounjaro? Or given the fact that you've now gone for two different brand names, you think that rebates in diabetes will be different from rebates in obesity?
Maybe I just address the last part of your question first. Two brand, brand names or trademarks. Why? I think the fact that we're talking about two different diseases is extremely important. The access piece, of course, we know that the process to gain access for obesity is going to be very different compared to type 2 diabetes. Some similarities, but also some significant differences in terms of opt-in. That's why we believe two trademarks are important. The second piece would be two trademarks also enabled us to to target and do some more precision marketing efforts for the different patient segments here. Because the needs of a person with obesity are very different from a person with type 2 diabetes, so it actually generates an opportunity for precision communication.
So I think in terms of pricing, there are different dynamics, and what we are seeing in the obesity market today is, with the employer opt-in, we have different qualities of access as well. So I think there are so many factors that are playing a role here. Like now, you see prior authorizations, you see utilization management. So I think it's very difficult to compare gross to net across two different disease areas and with different dynamics. But the drivers for the two trademarks were the ones I referred to. It is actually to make sure that our access efforts in obesity doesn't negatively impact type 2 diabetes and vice versa, but also to be able to reach patients with information that is relevant to them.
Excellent. So jumping on some of those comments, you've now got just less than two months, you can talk to, two months less, less than the year. And are you actively in discussions now with PBM access? And, you know, can you just give us some feedback you have from the PBMs, any early feedback you have there? And I guess jumping on one of your comments there, is it your expectations that you're going to see, you know, a step up within that prior authorization step edits?
You know, yes, we are definitely in discussions with the PBMs, and I think that's a part of the natural efforts prior to a launch. I think similarly, as we said at the time of the launch of Mounjaro, I think we are very clear we are aiming for broad and open access also for Zepbound. And we stated very clearly that we are aiming for a very well disciplined approach when it comes to access as well, and that has played out very well. So currently, when we look at Mounjaro, we are at 78% combined access in commercial and Part D. And if you look at commercial only, it's 85%, and we expect that to continue to increase over time.
Coming back to Zepbound, you know, I think we will take a very similar approach when it comes to Zepbound. We will aim for open and broad access with Zepbound, and we will take a very disciplined approach here as well, to make sure that what we do today is also something that is sustainable over time and it's the right decision for mid and long term as well. That's pretty much the efforts we have in place, and that's the recipe that we will comply with when it comes to the launch of Zepbound as well.
Okay, excellent. And you have a broad portfolio of other GLP-1s in obesity. How do you think about balancing what you have here? You've got certainly some towards the higher end of the efficacy scale in your pipeline. You've got some which are oral. You've now got one which is approved. So how do you think about when these are out, and it's probably going to be in the next few years, how are you balancing all of this?
Yes, I actually get that question quite often. And, you know, it's probably quite natural, because if you look upon the data on Mounjaro in type 2 diabetes, having 75%-90% of patients achieving an HbA1c below seven, which is the target by the American Diabetes Association, and in obesity, actually getting up to a weight reduction in the most recent study above 26%. That's huge. That's significant. That's a game changer across both type 2 and obesity. However, having said that, we know from the study populations that there is a huge variation in terms of response. And we will just continue to raise the bar. So when we look at the assets that are currently in development for obesity and type 2 diabetes, retatrutide, for example, S ometimes referred to as Triple G.
We believe that we will probably see even greater weight loss with retatrutide than we see with tirzepatide. And that is relevant if you think of a patient with a BMI of 35 or above, they might actually need even further weight decrease beyond the 25%-26% we can see with tirzepatide. So particularly target the class 2, class 3 obesity patients for retatrutide, and I think we have currently an unmet need that we probably can address even better with retatrutide. Moving on to orforglipron, which is the second asset in phase 3. Currently, that's the oral medication for obesity. We have learned through patient market research that there is quite a big group of patients that have a strong preference for oral treatment, and that's particularly true for the ones that are injection naive.
So I think that's one reason to be really excited about orforglipron, because you can meet other patient segments compared to what we are able to address today with tirzepatide. But there's also another factor when it comes to oral. So markets outside the U.S. that are heavily oral markets. I used to run our business in Japan for six years, and Japan is one of those markets that are very heavily leaning in towards oral, so China as well. So I think when you look at the portfolio, I think we're providing both healthcare providers and patients an opportunity to even further target the therapy to the needs of the individual patients.
And lastly, David stated very clearly in the last earnings call last week, you know, when it comes to the incretins and the medications for chronic weight management, the flywheel within Lilly is spinning quite fast today, and we just want to out-innovate ourselves. And maintaining that leadership position far beyond tirzepatide, it's really exciting today, but, you know, we see us making a significant difference for patients suffering from obesity, not just during the remainder of this decade and next, but even beyond that. So that symbolizes our efforts in that space.
And one of the interesting, more interesting products within that pipeline is also your acquisition of the Versanis product, where that seems to preserve lean mass. Perhaps what gives you encouragement from the data that you've seen for that product today? And perhaps can you outline some of the timelines we should be looking at, going out over the next few years?
Yeah. You know, the acquisition was finalized just a few months ago, so I think there is still a lot of work in progress in that space. But I know that our early development colleagues really spent some quality time to dig into the data on bimagrumab. For us, and I think it's well known today, that with not just incretins and GIP GLP treatments, but also with bariatric surgery, with diet and exercise, you see a muscle loss when you reduce your weight. And we have seen that with incretins and with our GIP GLP as well. You see approximately two-thirds of fat loss and one-third of lean body mass loss. And out of one-third of lean body mass loss, you also see some muscle loss.
And muscles are important because we know that they require energy, and they also impact the metabolism. So I think what we believe here, and the hypothesis we are going to study is by adding bimagrumab to tirzepatide, you would actually be able to stabilize muscle mass and maybe even increase muscle mass during treatment. That actually could be extended, and you would see a continued weight loss over a longer period of time, maybe slightly higher as well. So that's what we are studying.
In terms of the timelines, the acquisition was just finalized, so I think we are all hands on deck to make sure that we are developing the best development plan for bimagrumab as well, and taking the entirety of the portfolio, having the entirety of the portfolio in our mind as well.
There's a hell of a lot of different mechanisms being studied within obesity today by all other companies. Is there any other mechanism out there that sort of excites you guys, or any particular area that you're sort of looking in a big focus?
Uh, I-
Beyond, you know, beyond beyond.
I think from the way it should really be today, I think we are defined as being a leader in the chronic weight management, and there is nothing going on in this industry that we are not very much digging into. And I don't think there is a DDD being done in this space without us being consulted. We have some of the leading experts in the world and across research and development and commercialization. So I think, yes, we are always curious, and we look into whatever is going on, and if we believe in it, we will fully be in.
And, in terms of penetration, you know, this is a big topic for all investors today, especially into obesity. But, there's a segment of the market, Medicare, Medicaid population, that's not being reimbursed at the moment. You have the TROA Act, which is going through, Congress, I guess, at the moment. It's a bipartisan rule. What's your... Where are we now with regards to TROA?
You know what? I think we're very encouraged by the movement on TROA. As you said, there is a strong bipartisan support for TROA today, and I think that will provide an opportunity to treat patients in Medicare and Medicaid as well, consistently with treatment protocols for government employees and anyone on private insurance. We are still waiting for the scoring from CBO. I think that's a critical milestone that hasn't taken place yet, and I think that's a key event. Having said that, I think there was a hearing in the House Energy and Commerce Committee back in September that was quite encouraging, and where members actually raised the importance of providing access for patients in Medicare and Medicaid as well.
But particularly with the downstream benefits to underserved populations, including people with skin of color, and the potential impact of all of those 200 diseases that are currently linked to obesity. So I think TROA, I think it's not a matter of if, it's a matter of when. At least through our lens, we don't believe it's a near-term hit, but we believe it's going to hit. In the meantime, in order to provide access for patients in Medicare, Medicaid, I think the readouts that we will have next year, sleep apnea, HFpEF, those are indications that are currently reimbursed in part D as well. And while it doesn't cover everyone with obesity, there is a huge overlap.
We have 80 million people in the U.S. suffering from sleep apnea, and 70% of those have also obesity. HFpEF is a smaller population, around 3 million, and 75% of those have obesity as well. So in essence, yes, I believe that there will be progress made on TROA. I think there will, in the future, be access provided to patients in Medicare and Medicaid as well. I don't think it's around the corner. In the meantime, we have important readouts next year that at least could provide access for segments of people with Medicare and Medicaid coverage as well.
Excellent. And touching upon some of that, what's your expectations of some of the data that we should see next year for things like sleep apnea, heart failure, NASH? Perhaps can you talk about, yeah, your expectations for when this data comes out?
You know what? I think, first and foremost, sleep apnea. I think we've been very encouraging with the data we have seen in smaller scale so far, and we know that there is a huge need. There is no other pharmacological treatment approved, and we're talking about a significant need, 80 million Americans. And of course, we have a strong belief that this is going to read out positively, but I think that's pretty much what I can say today. But we are really, really excited about the readouts next year in sleep apnea, and the same goes for HFpEF. And I think we have reasons to believe that those are going to read out well.
When it comes to CKD and NASH, those are only in phase 2, and I think we haven't declared yet whether we are going to proceed to phase 3 and indications for those. But we want to bring the science forward in the GLP-1 space, for both NASH and CKD, and at the time of the readouts, those will inform our decisions for further development with tirzepatide or potentially with any of the other assets we have in our pipeline.
And this weekend, we have some data coming out from Lilly, with CV outcomes data in obesity. Do you have any thoughts on what potentially this could show here? Anything on the secondary endpoints that Lilly is going to be looking at?
You mean the SELECT readouts from-
Yeah.
Novo coming up at AHA? No, I think first and foremost, we were extremely excited when we saw the readout of SELECT. I think just coming back to the steps you need to pass in order to gain access for people with obesity, you have the employer opt-in. And I think in order to make significant progress on the employer opt-in space, you need to present some outcome data. And I think the outcome of the SELECT, it's really going to confirm the benefits of weight loss for this patient population, not just in terms of weight, but also in terms of the cardiovascular benefits. I think we will definitely follow the readouts of the secondary endpoints with a high amount of interest, that we are truly encouraged.
We also believe that since we see a significant higher weight reductions with tirzepatide, we don't see this as being unique for one asset. It's going to bring a benefit to the entire class, and that's going to be the first readout of many more to come. We have a readout of our CV outcome study in 2025, and we have also announced our morbidity and mortality outcome study, that is going to read out in a few years from now. But that's going to be key to really demonstrate the downstream benefits. And in parallel, there are a lot of real world evidence readouts, and real world evidence studies that we are triggering now with the approval of Zepbound as well. So expect much, much more outcome data over the coming quarters and years. That's going to be key.
You touched upon your readout in 2025. What are the main differences between the two studies here? So, you know, as a risk reading across this data to your clinical study.
Well, in terms of the major differences in between SELECT and the Novo trials, I have to say, I can't respond to that one today.
Okay.
But I think, particularly the morbidity mortality study includes significantly more endpoints. And I think it's a slightly longer study as well. So I think the morbidity mortality study is going to be really, really breakthrough data in this space.
Okay, excellent. Let's move on to diabetes. How's your communication been with the administrators, employers this year, and how do you think that's going to develop next year? I think, you know, we previously talked about step edits and prior authorizations increasing. How are we looking for next year?
You know what? I, I have to say, overall, we have had very productive discussions with, with the payers. And, as I shared earlier, we are pleased with where we are today in terms of the access, 85% commercial, and we see opportunities to further grow in that space. I think we are well positioned for 2024. Of course, with, with even further, further access, you would probably expect some, some increased, discounts and rebates, but at the end of the day, we see a huge minority after we stop the, the non-covered, copay card, scripts are being fully paid. So I, I think we are quite optimistic in terms of the outlook for 2024.
So I think in the diabetes space, I think it's relatively straightforward based upon the work we have done in 2023, preparing for 2024. Still some opportunities to upgrade coverage at a few places. Yeah.
So pricing pressure within GLP-1, is that still sort of the kind of low single digits and mid-single digit space?
We haven't announced a specific discount rates for by product. I think we have stated as a company, also in the most recent earnings call, that we are expecting a mid-single digit pricing headwind over the coming years, and that's for the entirety of the portfolio. But I think this is a space where you will see a lot of competition. So I think you have seen more or less every major pharmaceutical company announcing an appetite to move into chronic weight management. I think for us, it's just coming back to out-innovating ourselves. That's why we have a very rich pipeline, and we will continue those efforts to constantly raise the bar and being able to target treatments even better for patients.
And we know that when you bring superior product profiles to the market, you're in a better position when you negotiate for access as well.
Mm-hmm. Okay. At the last conference call, you spoke a lot about capacity. Penetration and capacity has been an issue this year. Where are we now today with the Research Triangle upgrade, the Concord coming online fully next year? Perhaps can you quantify your 2024 capacity goals?
It's, I think we referred to in the Q3 earnings call that, you know, the Mounjaro has been on the shortage list by the FDA until late Q3. It's not anymore, not for any of the strengths. So I think we have seen that in the marketplace as well. If we look at the capacity, I think we need to look at this through several lenses, not just the RTP site. But we announced that back in Q2, that we are up with commercial production and out of RTP. We also announced that we expect our second site in North Carolina, Concord, to start commercial production in Q4. What we haven't disclosed, though, is the number of lines for filling and assembly at RTP or the total capacity of RTP.
Each and every single of those lines need to go through a process validation, regulatory approval, start up production, and then optimize production. I think what you will see in 2024, it's a regular re-release of updates on new lines starting production. I think in terms of RTP, we are absolutely on track with the path that we committed to or announced back in late 2022, to double our capacity. Now in 2024, we will see that ramp up of capacity turning into production and supplying the marketplace from RTP. Beyond that, I think it's important to underscore the tremendous work that has been done to improve manufacturing and supply production out of our current sites.
We have invested heavily in our current sites as well, to upgrade those with tech and other investments to support supply of incretins, and those efforts will continue in 2024. The third component is while we have a preference for our own supply chain, just to control supply and quality, at time of launches and years after launch, we're also partner with contract manufacturers, and that will be continuously the case for tirzepatide as well. So those are three important components to take into account. Lastly, our efforts to develop new presentations for tirzepatide. We announced earlier this year that we have got the approval and launched Mounjaro in single vials in Australia and Canada, and that has been very well received.
We plan to continue to launch single vials outside of the US as a bridging into a multi-dose KwikPen , which we expect to get approval for in 2024. So in essence, I think we have all hands on deck to make sure that we are doing everything that we possibly can to ensure the best possible supply of both Mounjaro and Zepbound. But I think we need to reflect on the fact that we are facing an unprecedented demand. And we also have one uncertainty with the competition's ability to supply. So I think there will for sure be some constraints in 2024 as well.
I think that's realistic to expect, but I think we are really doing everything we can across those four levels that I referred to, and I'm extremely proud of my colleagues in manufacturing and quality for all of that effort. And I think we're on a good path, but it's not perfect yet.
Can I talk a bit about the multi-dose pen? I mean, one of the things that initially set tirzepatide apart from the competition was the administration device, and that was excellent. So can you talk about how this multi-dose pen kind of differentiates perhaps needle size, you know, what makes it convenient?
You know what, I think first and foremost, we still believe that the auto-injector is the premium device. So I think the auto-injector is what we are foreseeing to continue to be the presentation in the U.S. market. However, we always need to have some flexibility coming back to the discussion we had in terms of supply uncertainties and the competitive landscape, et cetera. But the auto-injector is a premium device, and that's how we view it as well. But taking into account the challenges we faced in 2023, we have had experiences with other medicines with a multi-dose device, and that has been very well received in the marketplace.
And that's why we had an opportunity to breach in markets outside the U.S. with a multi-dose device, which is really good, and it's a good bridging from the vials. I think the vials are probably the ones that we don't foresee remaining on the marketplace for a very long time. But taking into account the huge demand across the globe, that was a good entry point in several markets outside of the U.S.
Okay. So just wrapping up our discussion on GLP-1. Your competitors, there's been people out there who've discussed the market size of GLP-1. You've not really said, or Lilly, haven't really talked about the potential market size. So perhaps what are your thoughts there? And if you're not willing to give us a number, then what should we be thinking about?
Thanks a lot. Yes, I will probably not quantify the market size for you, but I can share with you at a holistic level, how we are thinking about it. Let us start with type 2 diabetes. In Q3, you saw TRX growth of 60% of incretins. Still, incretins and GLPs, that's only one third of the branded market for treating type 2 diabetes. And we believe, based upon the data we have seen right now, that there is an opportunity to move a medicine like a GIP/GLP earlier on in the treatment. And that means actually getting to disease control and weight loss much earlier, and that is an abundance of the current treat-to-failure model that has been existing for type 2 diabetes for quite some time.
So I would say just in type 2 diabetes per se, the opportunity for continued growth is quite significant. Then obesity, I think we have discussed quite a few times, but obesity, you know the numbers of U.S., U.S., 110 million approximately suffer from obesity. Outside the U.S., it's 650 million people. So close to 1 billion worldwide. That's a tremendous opportunity to make a difference and an opportunity for a medicine like Zepbound. And then we have the other indications, and most likely to come, sleep apnea and HFpEF, but again, with an overlap with obesity. So all of that is really going to drive a continued strong growth for incretins and GLP-2s.
I think it's just important to have in mind that the employer opt-in and the barriers to access for obesity, that's something we need to overcome, and that just underscores the importance of outcome data, and we are starting to generate those now, that we need to overcome those barriers at an employer level. That's—I think that's probably the biggest barrier to really capitalizing on the tremendous opportunity and the needs, the medical needs that are there. So that's how we are looking at the market at a holistic level.
Yeah, it's interesting you talk about the access side of things, because when you see a $100 billion market for GLP-1 being thrown around, I mean, how realistic is that from, one, a capacity standpoint, and two, an access standpoint? And do you think ... And we discussed very briefly there with orals, do you need to have orals there, so you can have a $100 billion market because of the capacity for anything?
Yeah, I think there are several aspects to take into account here as well. If you think of the entire global need for obesity medications, I think even if you combine the capacity of Eli Lilly and Novo Nordisk in a few years from now, that will probably not be sufficient to satisfy close to 1 billion people across the globe. So I think that's one important aspect of it. B, I think, yes, we have stated very, very often that we will need to have an effective oral, and I think that's what excites us with orforglipron. Because orforglipron actually has demonstrated in phase 2, a weight loss in parity with the most effective GLP, not comparable to tirzepatide, but the most effective GLP, and with no restrictions in terms of food and water intake.
So I think that represents a tremendous opportunity for us as well. So yes, I think you need more options here in this space to really meet the entire need, but I think it's going to be a gradual ramp up here as well. The last component would be just if you look at markets outside the U.S., currently, most of those are single-payer markets. And in most of those markets, in a minority of those, obesity is not yet reimbursed, and probably driven by the prior experiences in the obesity space. Medications that were launched 10 years ago, in best case, generated a weight loss of 5%-6%, some significant side effects.
When those one single payer start seeing outcome data, seeing the benefits from a cardiovascular perspective, from a hepatic perspective, from a type 2 diabetes perspective, I think there are quite a few of those single payers that actually will change their mind as well, and we will see reimbursement of chronic weight management medicines outside the US to a significantly higher extent than we do today.
Yeah. Yeah, those, those single payers is just much more joined up than it is in the U.S.
Yeah.
Yes, they'll see that benefit.
Yeah.
Okay, so we're approaching the last 10 minutes. I did promise we would be talking about immunology as well. So Patrik, you are currently the president of Lilly Immunology. It continues to be an area of investment for pharma. You can see that with R&D budget spend, phase III trials, BD. What makes immunology still attractive to Lilly? Because it also is quite a competitive environment, and there are pricing headwinds and generics coming in.
Well, I think when many people are reflecting on immunology, they are thinking about the progress that has been made in disease states, such as psoriasis, some rheumatological disorders. But there are so many different diseases in the immunology space, where the unmet needs are still huge. Lupus, hidradenitis suppurativa, Sjögren's, even rheumatoid arthritis. You know, today, we are still measuring progress with ACR50. We would never bring a medicine with an ACR50 today to the market to treat psoriasis. So I think in the space of psoriasis, we are in a good position. But across most of the immune-mediated diseases, there is still so much more to be done.
And I think even in some of the areas where we have seen a lot of competitive movements over the last 12-18 months, such as IBD, Crohn's and ulcerative colitis, the penetration of biologics and overall is very low. In IBD, it's 15% for ulcerative colitis, for example.
Mm.
I think based upon the unmet needs, I think when you're targeting the right disease areas, there is still so much to be done in that space, and that excites us.
And you have a recent approval with mirikizumab or Omvoh, I think. How do you pronounce that? Is that-
Omo.
Omo.
Yeah.
Okay. In UC, you've had positive phase III data in Crohn's. Perhaps can you talk a bit about that data, what excites you there, and how this will differentiate itself within a very competitive market today?
We're very pleased to have received the approval for Omvoh in the U.S. as well. We launched in Japan and in Germany earlier this year. The feedback from the marketplace, always very early days, is very positive. When we look at the launch of Omvoh and the future prospects here, I shared the low biologic and oral novel penetration in that space. That's a huge opportunity. But for patients with ulcerative colitis and also Crohn's disease, they cycle through treatments very rapidly because the level of remission that most of them achieve is far too low. And I think what encourages us, first, you see, is the remission data, and we acknowledge that we don't have head-to-head trials.
With all of the limitation of cross-trial comparisons, if you look at where we are with the remission data, with 50% of patients achieving remission by week 52, that is really good, and it compares very favorable to what's currently in the marketplace and what is in the pipeline of competitors. The second piece of differentiation, particularly in ulcerative colitis, is bowel urgency. When you talk to patients suffering from ulcerative colitis and from providers, it's now being recognized as one of the most bothersome symptoms with ulcerative colitis, and really devastating in terms of quality of life. We are the first ones to truly lean in on bowel urgency and starting that with a numeric scale compared to the binary one that normally exists in clinical trials. We could demonstrate a significant difference from placebo already after week 2.
At week 52, around 40% of all patients are bowel urgency free or almost bowel urgency free. The beauty of the result is that you see a similar response in the bio-naive and the bio-failed population. So I think that, in its entirety, positions us very nicely at launching as the first IL-23p19 in ulcerative colitis with a differentiated profile. So we're excited about this opportunity. Crohn's, the data were just released a few weeks ago as well, and I think are some similarities, particularly when it comes to remission. We're at 54% of patients achieving remission by week 52, and similarly here, consistent results across bio-naive and bio-failed populations. So I think we are well positioned entering into gastroenterology for the first time with two differentiated profiles across those two diseases.
I think by default, we will probably be positioned second line to start with, but I think we have the data and the plans to work our way up to a first-line position in both UC and Crohn's disease.
Excellent. Is there much infrastructure that's being put in here? 'Cause like you say, this is a novel or a different area than you're used to.
Well, yes. When we are moving into a new disease area, we need to use some, build some new capabilities and bring in some new expertise. But I think this is something that we started pretty much by the investment in IBD, and we announced, I think it's three years ago, that with mirikizumab, we also have the data for psoriasis. But we said, "You know, we don't see a huge unmet need in that space, but we have much more to do in IBD.
Mm.
So we actually started those investments three years ago, and of course, we have the separate sales force for gastroenterology, but we also have a strong infrastructure base foundation in immunology that we capitalize on across the different disease areas.
Yeah. And you have lebrikizumab, hopefully next year at some point. You're working through a CRL. How quickly do you think you could work through that? But also, how should we think about the ramp there? Because if you got approved this year, potentially you could have spoken to, you know, some formularies, but next year, you're kind of late for next year being in the formularies. So, yeah, and also, this is a very competitive area. Again, do you expect to have any patient assistance program put in place? So just trying to think about the ramp for next year for that product.
Yeah, you know, first, maybe the CRL, to, to make it clear to everyone, the CRL raised no concerns when it comes to the efficacy, the safety of the label of lebrikizumab. It was all related or driven by a multi-company sponsored inspection as a third-party manufacturer. And as we shared, when we got the CRL for mirikizumab, we said, "You know, we are going to work very closely together with the FDA to solve this as soon as possible." And we are saying the same with lebrikizumab. We work very closely together with the FDA and the third-party manufacturer. This doesn't impact our confidence in lebrikizumab at all. And we have also made the commitment that when we have something maybe to, to share, we will do that, as we did at the time of the resubmission of Miri.
And we worked that through in pretty much six, seven months time period. But we're doing everything we can to accelerate the approval of lebrikizumab. When we launch in atopic dermatitis, yes, it is a competitive space from one perspective, but if you look upon the medicines that have launched in atopic dermatitis, it's still extremely dominated by one, Dupixent. And I think there was a huge disappointment with the Adbry data, pretty much replicating the very weak phase two results in phase three. And also with the number of injections with Adbry, I actually don't think that they have given a tough competition to Dupixent at all, and the JAKs have been placed very late in the treatment algorithm.
So I think the consistent feedback we hear from the formulary community, from the PBMs, is the desire to have a profile along the lines of lebrikizumab. And, you know, when you look at the data here from phase three, and we just recently released the two-year data as well, with 80% of patients achieving skin clearance by week 52, and with itch relief, quality of life improvements. And what we saw in the two-year data, still 80% of patients actually with clear skin and good disease control, but we saw that with a Q4W formulation.
So that level of efficacy and differentiating with a Q4W versus a Q2W that is in the marketplace today, we believe that lebrikizumab positions us actually to launch a first-line biologic targeting the most relevant cytokine when it comes to atopic dermatitis, IL-13, and doing that with a slow off rate and high potency and affinity. And timing makes a difference in terms of contracting for sure. We can't neglect that. But what we currently experience is actually a strong interest at the PBM level for a product with a profile of lebrikizumab. But we will also here take a very value-based approach in our pricing and negotiations with the PBMs, because we believe that the potential with lebrikizumab is quite significant.
Okay, excellent. I can see the clock is counting down for a minute, so I have one last question left for you. As you exit your role in immunology, what's the main challenges that you leave behind for Dan?
Well, I want to make sure I keep him busy for a few years, huh? So I, I think for Dan, you have probably different levels. The first one is not unique to immunology, but IRA is impacting immunology development as well, particularly with the orals. So I, I think it's just how we are lining up the different unmet needs by molecule. I think that's, that's a big one and a very important one. The second one, specifically immunology, are the rebate wars. I, I think immunology has been very particular in that regard. I, I see some light at the end of the tunnel, and I think the launch of the biosimilars will partly change the landscape here.
I also think our presence in immunology will make a difference, because we will have a nice portfolio of the only ones with both IL-13, IL-17, IL-23 and a JAK inhibitor, hopefully by the end of 2024. And lastly, would be just all hands on deck with the CRL, continue the efforts to solve this as soon as possible for lebrikizumab. But I think those are at a macro and a more detailed level, what I will leave with Dan, on top of everything that needs to be done on a daily basis to remain extremely competitive in the marketplace and continue to raise the bar in terms of how we best serve patients with immune-mediated diseases.
Excellent. Well, thank you very much for your time. It's a momentous day for Lilly. It looks like you're going to have your hands full this coming time next year. But thank you again for your time.
Thank you, Trung. It's... Yes, it's truly exciting for Lilly, and today is a game-changing day for patients and a historical day for Eli Lilly and Company. But thanks a lot for the opportunity to be here.
Excellent. Thanks very much, everyone.