Morning. I'm Chris Schott at J.P. Morgan, and it's my pleasure to be hosting this fireside discussion this morning with Viatris. We're going to have a quick presentation from CEO Scott Smith, and then we're going to open up to a Q&A session with the broader management team as well. So with that, turn it over to Scott.
Thank you, Chris, and thank you everybody who is in attendance today. Very nice for you to come. Just let me flip this over. Forward-looking statement to put on here for a second. We're going to be talking about forward-looking things. So just before we get started, I'd like to just give a little snapshot about Viatris and who we are as a company. We're not one business. We're actually three separate businesses: a global generics company, an established brands company that owns some of the most iconic brands in the world, so you can see up there, and an emerging innovative brands platform. Over the last 12 months, we've delivered $14.1 billion in revenue, $4.1 billion in EBITDA, and $2.2 billion in Adjusted EBITDA, $2.2 billion in free cash flow, sorry, $2.32 in adjusted EBITDA, and $2.2 billion in free cash flow. Currently, we operate in 165 countries.
We have 1,400 unique products, and I think what we're most proud of as an organization is the fact that we deliver medicine, provide medicine to over 1 billion people annually every year, which is a pretty amazing feat when you think about 15% of the world's population we service as a company, and we're very, very proud of that. It's a very nice position or anchor for us to be able to positively affect human health care, and so we take it very, very seriously. We're also very proud of what we accomplished in 2025. 2025, as most of us know, was a little bit of a volatile year. Started off, I think, a little choppy. Certainly cleared up towards the end, but was very proud of the organization and what we were able to accomplish. We drove strong commercial execution across our global portfolio.
We advanced our pipeline, including five positive Phase 3 readouts out of six Phase 3 readouts, so five out of six, a very good ratio there. Significantly, we also advanced cenerimod and selatogrel and lucerastat very substantially in their Phase 3 programs, and we're getting towards the end of those Phase 3 programs now. We prioritized capital return with greater than $1 billion return to shareholders through dividends and share buybacks. We had targeted accretive regional business development, including the acquisition of Oculys in Japan. We actually did 60 regional business development deals last year to support the base business. Japan was one of my strategic priorities as a country to be able to put products in.
Because of the age of the portfolio, we have a little bit of a declining revenue stream in Japan and an inability to change workforce size because of labor loss, so it was very important for us to find new, innovative, high-margin products to put into Japan, and we were very, very happy with what we were able to do there. We substantially completed the remediation at our Indore facility and met with U.S. FDA to discuss potential timing for reinspection of that facility. We conducted what we call an Enterprise-Wide Strategic Review to help make Viatris more focused, efficient, and future-ready. The result of that will allow us to not only reinvest in new parts of the business but also achieve substantial savings over the cost footprint that we have today.
And we were able to do all of that while substantially refreshing both the leadership and the board of directors during 2025. So I think a year of very substantial accomplishment. There's obviously much, much, much more to do as we go into 2026 and beyond, but I'm very proud of the organization for what they were able to accomplish in 2025. And I think that hard work in 2025 has set us up to be able to really execute in 2026 and beyond, set up for a different type of frame and a different strategic setup for 2026 and beyond. First of all, we have a number of anticipated high-value launches coming, and Philippe will get into this in more substance, but just a few highlights of those. Sotagliflozin, or what I call soda in most of the rest of the world. We have phentolamine.
We've got low-dose estrogen and meloxicam, sorry, fast-acting meloxicam, in the US, and in Japan, Spidifen, pitolisant, and also Effexor GAD. So we've got a very substantial number of launches in very important geographies for us. And again, Philippe's going to talk a little bit more about the pipeline in just a second. We've engaged in this Enterprise-Wide Strategic Review, and we'll start to see the real benefit of that playing out in 2026, 2027, 2028, but the start of that will happen in 2026, which, again, the purpose for that is to make sure that we are fit for purpose not only for 2026 but going forward. And the net of that will be monies to reinvest in different businesses as we move forward and the base business, but also substantial savings to the company as well.
We expect to obviously generate a very significant cash flow during the course of 2026. With that cash flow, the plan is to be able to continue to return to shareholders dividends, share buybacks, but also start to really build a portfolio of growth assets through accretive in-market business development in the U.S. and also business development globally as we've been doing for the last few years, and then also we have a very large number of pipeline milestones coming in 2026, and let me just kick it over to Philippe to talk a little bit about that.
Thank you, Scott. Good morning, everyone. I don't know if the microphone is working. It is. So as you mentioned, last year we had five positive Phase 3 results, and based on the strength of the data that we're seeing with these assets, we anticipate they will be getting approval this year. In addition to these positive results, we acquired pitolisant and Spidifen in Japan. Spidifen was launched recently at the beginning of this year, and pitolisant, we were able to file for both indication treatment of excessive daytime sleepiness for narcolepsy and for sleep apnea at the end of the year and anticipate approval this year. In 2025, we also made significant progress with our pipeline, in particular with cenerimod and selatogrel, where we believe we'll have full enrollment this year for both of these assets.
We're still very confident in the profile of these assets and believe they have the opportunity to answer a significant unmet need, but I'm sure we'll get into more details during the Q&A session.
Just sort of wrapping up 2026, the strength of the base business together with the benefits of this enterprise-wide strategic review, together with this evolving pipeline, and also our ability to acquire assets as the portfolio are going to take us to a longer-term period of sustainable top-line and bottom-line growth, which starts in 2026. We're really excited to get into 2026. There's been a lot of hard work to get us there and paying down debt and restructurings and other things, but we're very, very excited about the platform that we're going to launch going forward 2026 and beyond. With that, I'll turn it back to Chris for the Q&A portion.
Perfect. Thanks very much for those comments. So I thought maybe just starting off at the high level, you're still three years in the seat as CEO at Viatris. As you think about the business today, I guess, what are you most excited about as you've seen how the business and the portfolio has evolved?
So a couple of things that I'm excited about. First of all, I'm very excited about where we are from a company perspective and an employee perspective around the world, right? There's been divestitures. There's been some restructuring. We've added some skill sets as we move forward. I think we've got a very strong core group of employees worldwide, and I'm excited about that. I'm excited about the leadership team. And you can see, if you had seen a presentation three years ago, there's all different faces here. We have refreshed the leadership team. We've brought new skill sets in, and I'm very, very pleased with the people that we've been able to bring in, the quality of people, the skill sets, etc. But sort of what I'm most excited for is just getting into this next three to five years.
As I said, there's been a lot of hard work to get us where we are today. I see a very strong period of stability for the base business. We have eight, nine, ten quarters in a row now in Indore of 1%-2% revenue growth, so I think we've really stabilized that base business. We've got the cost benefit and the structural benefit of the enterprise review that we're doing. We've got an ability to be able to do business development and add things to the pipeline, and we're going to continue to build the pipeline, our portfolio of growth assets, and as you can see, we've seen a real acceleration in the pipeline over the last 12 months or so, starting to really yield results and higher margin, higher impact products that we'll be launching in 2026 and beyond.
We've got a number of data readouts in 2026, which are going to be really important for us. Just the whole setup, I'm really excited for us, for our investors, for our employees to be moving into a period of sustainable top-line and bottom-line growth over the next three to five years.
Great. And maybe just building on that, how are you thinking about the magnitude of that top and bottom-line growth and whether it's top-line margins to a little bit more color there?
Yeah, so I think we're going to get more specific around what those numbers look like, obviously, when we get to the Q4 guide for 2026. But again, we've seen this sustainable period of 1%-2% revenue growth. If you think about the impact of these launches, you think about the impact of accretive in-market business development that we can do during the course of the year, I would expect that to move to sort of mid-single digits from a revenue perspective. And when we get to the final numbers on enterprise review and those sorts of things, we'll guide on what the bottom line looks like. But the important thing for me is we're no longer going through a period of revenue and EBITDA decline. We've stabilized in 2025, and we're moving towards a real growth in 2026.
We'll be fully transparent and get all the numbers out there at the right time when we're able to do that, but we're very, very excited about where we're going.
Yeah. On business development, can you just talk maybe about the landscape that you're seeing out there? And I guess maybe just looking back to 2025, is that kind of indicative of what we should expect from Viatris or for those targets and the type of assets you pursue maybe kind of change over time?
Yeah, so I think in any one year, I think the year before, we did something like 41 regional deals. We did 60 last year. We're going to continue to do those. We've got a very substantial infrastructure globally, commercializing in 165 countries. We need to feed them with new products, and we need to continue that. And we're a very good partner for companies which could maybe see themselves commercializing in the U.S. but not internationally. And so we do have the infrastructure out there. We're very proud of it. It's working at a very high level. We've got large affiliates in places like China and Japan and Italy. And so we're looking to add things there. From a U.S. perspective, we're looking for accretive in-market assets that we think we can be good owners of, right? And I'm less about what therapeutic area are we really looking at.
I'm looking at, can we as a company be good owners of those assets? Can we add something that the company that we're acquiring from doesn't? And some of the things that we can do, I mean, we've got tremendous product line extension activities. We've got extensive development abilities, which we can add second and third and fourth indications on. We've got access infrastructure. We've got global commercial structure. And so there are assets out there which I look at, the sweet spot being in the $500 million-$1 billion peak revenue kind of range. And we're looking for assets that we can then build off of, and it can become a cornerstone of a therapeutic area we go into moving forward. But I'm less concerned about the therapeutic area and more concerned about, are we the best owners for that particular asset?
Just the landscape for those type of assets, are you seeing a lot of opportunities?
I think there's a lot of opportunities. Again, when I think back to early 2025, and we were struggling internally with some of the things on Indore, there was a lot of discussion around tariffs, obviously, healthcare policy. It seemed like there wasn't a lot of movement from an M&A perspective. Certainly, as things have changed, and I feel like there's a lot of companies out there, I think we're in a little bit of a sweet spot as well ourselves. You look at the big pharma LOEs that are going to happen over the next two to three to four to five years, and they're multi, multi-billion dollars. And to replace that, you need big assets. We're looking to add multiple $500 million-$1 billion assets. There's not as much competition for those assets.
So I think there's a lot of things out there which are very doable for us.
Excellent. I know we're also awaiting some details on the company's Enterprise-Wide Review. Can you just talk a little bit about maybe setting the stage of what we should expect here in terms of the scale of this review and the phasing of when those savings could flow through?
It's going to be substantial. It's going to be substantial. Again, when you take a step back and look at why are they doing this, it's not just about saving money, right? We merged in 2020, 2021. We divested four major businesses, which were core to our future. And as we took a look at going into 2025, the uncertainty in the marketplace, the Indore situation, it seems to us to be the right time. And we accelerated this idea that we really need to look at the company, and we need to look at it from this lens. Do we have the right people in the right places to be able to deliver what we need to deliver in 2026, 2027, 2028, or is this a structure which benefited us in 2020 and 2021 but is not fit for the future?
So we want it to be fit for purpose. And I think when you divest businesses and you don't really look at that structure, I think there's a real ability to become more effective and more efficient in a lot of different areas. And I think we're looking at everything, right? We're looking at procurement. We're looking at marketing practices. We're looking at development practices. We're looking at centers of excellence. We're looking at everything in the company. And the net of that, I think, will be an ability to refocus resources on more resource-responsive assets, right, that we can grow faster, some of the new pipelines, some of the new things that we're doing. But also, I think there'll be substantial savings, which will help us grow our EBITDA over a period of time.
On that point of reinvestment and just directionally, how much of the, I guess, gross savings here should we think about being reinvested in the business?
Without giving it a ratio, because I don't know exactly, I think it'll be the portion that drops the bottom lines and savings, I think, will be more substantial than the reinvestment.
Okay. And the reinvestment we should think about is mostly going towards some of these growth assets. Is that?
Growth assets. We've got launches. I think we've got other assets out there that may not be launch assets that may be underfunded in different places. And so we really took a look at the portfolio, all of the 1,400 products and 4,000 SKUs and all that. And it's quite an effort in this company, which is very large and very diverse, and wanted to make sure that we were applying the efforts in places, the promotional efforts in places that were promotional responsive, that would be good return on investment for us.
Great. Moving maybe to 2026. I know we're going to be getting into guidance fairly shortly. Just early pushes and pulls we should be thinking about for the business entering this year?
Great. Yes. Thanks, Chris. We're pleased with how the year ended, and we expect that momentum to carry us through as we think about 2026. As Scott mentioned, 2026 is really shaping up to be a catalyst-rich year for Viatris. So as we think about the tailwinds, there's a number of things that we're excited about. Greater China and Europe continue to perform strongly for us. In North America, now that we've left Indore, that business is strengthening, really supported not only by the complex generic products that have gotten approved and launched, like iron sucrose, Sandostatin, as well as paclitaxel, but importantly, upcoming launches, not only on the complex generic side, but on the branded and innovative side as well.
In Japan, that market is really at an inflection for us, really supported by some of these innovative portfolio that we anticipate launching this year: pitolisant, Effexor GAD, Spidifen, and then in emerging markets, that business, we'll start to see contributions from the launch of Sotagliflozin in certain key markets there, so a lot to be excited about overall in the business, and then lastly, on the enterprise-wide strategic review side, we should start to see net savings drop to the bottom line starting this year.
Encouraging.
Just a comment that we, and I'm the most guilty person here, but we get so excited about the inflection points, the things we need to invest in, the opportunities that we have ahead. We don't, for a second, take our eye off the base business, right? It's $14 billion in revenue, and that base business is what leads to the EBITDA and cash flow to allow us to expand the business. So although we end up, people are interested and want to talk more about it, and we talk a lot about it, my message to the company inside is, first and foremost, we need to keep that base business as stable and solid as possible. And that gives us the opportunity to explore other opportunities.
And just on the headwinds side, we have the normal pricing and policy adjustments that are facing our JANZ business. We also expect to have some generic competition due to the loss of exclusivity of Amitiza in Japan, and then just normal kind of competitive dynamics in North America and certain markets. But I think the message is, when you take a step back and you put all these pieces together, we're pleased with the position that we're in entering in 2026, and our focus really is on execution this year.
I know Indore was a headwind for last year. Just update in terms of where we are with that facility. And I guess just directionally, how much of a volatility factor should that be in 2026 numbers?
Yeah. So the way you can talk about the numbers, but let me, so sort of the way that I look at Indore and the remediation where substantially finalized. And it's a little bit of the vanishing zero concept here that on a plant like that, with so many, it's a gigantic plant involved in an incredible amount of manufacturing. There's so many bits and pieces to it that to get to that 100, right, it takes a while. But we're 90%, very close to 100% remediated there.
We had a meeting, I think, which was November 4th with the FDA on the process going forward and the timing for them to come and inspect. I mean, it's up to them when the reinspection happens. It's not up to us. But for me, the most important point here is by the time they come to reinspect, hopefully commercially, it's a non-event, right?
Whether it's approved or not, and we certainly expect it and hope it to be reapproved. But we have found duplication in where we manufacture things. We found alternate sources. We found external sources. We built redundancies into the system so that when that comes online, it's not a financial positive or negative. It doesn't come online. It's more of a reputational positive for us, gives us some flexibility, may allow us some cost benefits to manufacture things in a different way. It's one plant in a network of 26. But we've done the hard work since we got that Import Alert to be able to find the redundancies and alternate sources so that we can keep or regain as much of that business as possible.
Excellent.
And I would just say the net effect of that, to answer your question, is we see limited volatility as it relates to Indore in terms of our 26.
Okay. We have your mic now for the financial policies, Jeff, and capital allocations, coming back to that quickly there. Just how should we think about total capacity for capital allocation over the next few years?
Yeah. So I think that from, and again, Jared can get more specific on some of the numbers if we want here, but we're going to have a good capacity in 2026. We ended the year in 2025 with substantial cash balance. We have negotiated an arrangement with Biocon to monetize our equity position in there, and that'll be coming to us. We also expect, of course, substantial cash flows from the business. So I think we're going to have more than usual capacity in the course of 2026. And again, we are, from a free cash flow perspective, $2 billion plus going forward for the next foreseeable five years, and that will grow over time. So we think we've got good capacity.
Relative to capital allocation, as I talk about a lot, I see it over the next three to five years as 50/50 kind of between return to shareholders through dividends, continuing to dividends, share buybacks, and then business development as well. Any one year, we may lean more into one than the other. Last year, we leaned into buybacks. Given the volatility, the depression in the share price, particularly early in the year, it's sort of, and the lack of real business development opportunities over there, we sort of leaned into business development, or we leaned into share buybacks and, of course, continued the dividend. This year may be one where we lean a little bit more into business development. We need to do both, right?
We need to return to shareholders, and we also need to build a portfolio of growth assets with this cash to really have sustainable long-term revenue growth for the company.
From the earlier comments, it sounds like some of the priorities is U.S., more revenue-generating type of assets. Is that fair? Globally, is there a similar appetite ex U.S., or do we see some R&D deals mixed in there as well?
Yeah. I think, again, we did 60 deals ex-U.S. in 2025. I would expect that the Hamilton team will do another 60 this year. They're very busy doing those, supporting the business. When I took a look sort of last year, beginning of the year, what are the real strategic priorities to build this business? There were two things that really popped to the top from a commercial perspective for me. First is the United States, largest business, highest margin. It's only 25% of our global revenues, which is disproportionately low relative to our peers, and so a real opportunity to build there, and the other one was Japan, where, again, you have a declining revenue base because of the age of the portfolio and government-mandated price decreases and an inability to change the size of your sales force substantially because of labor laws and things.
And so we really set out to bring some assets in there. We charged up the internal development and developed Effexor GAD for Japan, but we also acquired Oculus and the assets that they have for Japan, Spidifen, and pitolisant. And so we think we're going to put a growth profile on Japan going forward as opposed to a revenue decline profile. But certainly, in the short term, we're focused on in-market, accretive, high-margin U.S. revenue.
Okay. Excellent. Very clear. Moving to the pipeline, Melissa Camp, some solid data in a key pain last year. Just remind us how you're thinking about the opportunity for that market.
Maybe we'll ask Corinne to do that.
Great.
I'm sorry, I didn't—so I'm remiss. There wasn't enough seats. Philippe, who you met before, who's our Head of R&D, obviously Jared, our CFO, and then Corinne Le Goff, our Chief Commercial Officer, who's in the front row off the microphone not up here because there wasn't room. So please, Corinne.
Thank you. Thank you very much.
Hi, Chris. So we are very excited with the meloxicam data that we and the readout that we had last year. And we look at this opportunity as a very broad opportunity. The market for acute pain, moderate to severe acute pain, is really very broad, especially when you're looking for non-opioid pain relief. And it's an important point because if you look at the United States, you have about 80 million pain cases every year, and half of those patients still get an opioid despite the known risk of dependence and abuse. So we see that with a product like Fast-Acting meloxicam that acts fast, very rapid absorption, works very well, high efficacy, and has the potential to decrease the use of opioids. It's a very, very strong positioning. In terms of market segmentation, you can make the differentiation between operative pain, so post-surgical pain, or non-operative pain.
We've generated a lot of data in operative pain, soft tissue, and hard tissues, and our focus will be on those patients that are mostly seen in the outpatient setting or ambulatory surgery centers for hip replacement surgeries or knee replacement surgeries, or patients that are seen in office, like dental surgeries, cosmetic surgeries, so it's a large opportunity. We'll be very focused, and we are very excited about it.
There's another part of this which excites me as well, right? The opportunity is very, very large, but the data in and of itself, which is what really is the sort of lifeblood, the fuel for products to be successful. When I look at that data and I look at other products, more recent products, I think that data really is outstanding. No head-to-head. I'm not saying we've done any comparative data, but if you just take a look at the data and see what it says relative to opioid sparing and other things, it really is pretty remarkable data. The combination of that data, which is remarkable, with the size of the market, the unmet need, the fact that opioids are still overused, I think creates a tremendous commercial opportunity for us.
To access that, I guess, just talk a little bit about the investment and commercial infrastructure we need to think about here.
Yes. So we are looking at focusing on those outpatients where you have the largest volume of patients and specifically looking at building an organizational sales force, a specialty sales force that will focus on those targets like orthopedic surgeons or general surgeons. And we might want as well, and we are in the process of finalizing our commercialization strategy, but we might want to expand our reach on targets like PCPs potentially or dentists. And we'll do this as a partnership. So we're going to be very disciplined in how we apply our dollars. And what we want is to maximize the opportunity for Fast-Acting meloxicam and the value of the asset.
Excellent. Maybe one last one on this one. Just IP exclusivity. How do you think about the runway here?
I can talk to this as well. We're going to launch and promote Fast-Acting meloxicam as a branded asset. It's a 505(b)(2). We have at least between three or five years of runway, but we also have five additional patents that will potentially extend our runway. Again, it's a very strong opportunity for us.
And I don't know that there's a better company in the world to expand that patent estate given the history of the company and the lawyers that we employ and the experience that they have at this than us. And so I think we're in a really good position. I look at this as a very strong contributing asset through this decade and into early 2030. And whether that's 2031 or 2034, we don't know yet. We're going to work to expand that. But certainly, through the end of this decade, it's going to be an important portfolio contributor for us.
Great. Maybe we can go to cenerimod. Just remind us how you're thinking about the opportunity in SLE and how you think about this asset maybe fitting in the competitive landscape for the market?
Yeah. So in SLE, it remains a significant unmet need, and there's a specific unmet need for an oral treatment with the right benefit risk profile that can be given on top of standard of care. And that so far is the data that we've seen from cenerimod fits that profile very well. What is particularly important for cenerimod is that the mechanism of action of the asset fits very well with SLE. It tackles all three key pillars of the disease. And we've seen that in phase two, right? We had three phase two studies at the four milligram dose. We've seen robust, consistent data that led to the design of the phase three study.
So strong data, strong mechanism of action supporting the use in SLE, and a significant unmet need for an oral treatment that can be used prior to those more aggressive biologic assets that have a different benefit risk profile.
In a different world, Philippe and I were interested in developing an S1P molecule that we had in SLE, but it never got there for reasons other than whether or not it would work. But I think it's a very, very solid mechanism to take into SLE.
Great, and pretty much just the timing of the phase 3 readout for this one.
Yeah. So we fully enrolled the first of the two phase 3 studies last year, and we are very close to enrolling the second phase 3 study. So we anticipate that the readouts will come toward the end of this year, early next year, and we'll go from there.
Great. We also recently started phase three in lupus nephritis for this one. Just talk about what gave you confidence to go there and how we should think about timing of that data.
Yeah. I mean, I think lupus nephritis is a similar thought process than with SLE. The mechanism of action of cenerimod fits very well with lupus nephritis as well. In particular, we've seen our best data in interferon-1 high patients in more severe patients, and the lupus nephritis patients typically are interferon-1 high and have a more severe disease, so that was important for us to do that, but before we embarked on lupus nephritis, we had to do a number of clinical pharm studies to make sure we could give the data to more renally impaired patients. That data came back last year, and we saw an ability to give cenerimod to all patients with renal impairment, including severe renal impairment, which helped us design the study.
It's an all-inclusive study, probably the most inclusive study that has been run for lupus nephritis based on the profile and based on the benefit risk we've seen with cenerimod so far. So very excited to see the result of that study as well.
Excellent. Shifting to selatogrel, can you just talk about the market opportunity here and what's going to be required to build out the market for this one?
Yeah. Maybe I'll start with the patient that I asked Corinne to add. I mean, if you look at the U.S., you have about six million patients that have a history of MI, and every year, about a million patients get an acute myocardial infarction. So that represents a significant opportunity for us. And again, this is a completely novel approach that addresses the main unmet need, which is the time between the symptom onset and the first time a patient sees a medical professional. So we are very excited about what we're seeing and look forward to showing the data when available. Corinne?
Yeah. I really believe that selatogrel will be a paradigm shift in the management of acute MI. And as Philippe said, there is a tremendous unmet need because MI today is responsible for one-third of deaths in developed countries. And you should know that 30% of those deaths occur before the patient has the time to go to the hospital. So early intervention, self-injection with the patient, will be absolutely crucial in saving lives. So we are very enthusiastic about the potential of selatogrel. As Philippe mentioned, it's a large market opportunity. Globally, he gave you the U.S. numbers, but globally, there are 25 million patients that had an MI. 2 million a year have an incidence of additional MI. So it's a large market opportunity.
We need to remember as well that as an organization, we are very well placed to commercialize this asset because we have a very long experience in rescue medicines with products like EpiPen, and we are very well positioned to do the necessary patient education, advocacy, and we will also globally leverage the infrastructure that we have in cardiovascular. Very good asset in our hands. I'm very bullish about it.
Absolutely. And although we may have to build some infrastructure in the United States from a cardiovascular perspective, we have $4 billion worldwide in cardiovascular sales. So it fits very well therapeutically, particularly ex-U.S. And we've got a large commercial structure out there that's promoting a number of different cardiovascular brands. So it will fit. And I love what Corinne said. Is there a better company to commercialize life-saving self-injection therapy than us? So yeah, I think we have the data's got to be positive, right? But I think given the unmet need, the paradigm shift, the ability for us to manufacture the devices, sell the devices, and all that, I think we're uniquely positioned if there's positive data there to make a real substantial product out of selatogrel.
Maybe one last one. Just what are the challenges about the self-administration here? And is there any real-world data you have from the studies showing about the ease of actually doing this?
Yeah. So I mean, as you can imagine, we look at the blinded data on a regular basis. We also have unblinded DSMB that looks at the safety data on a regular basis. I think what I can say, what we're seeing is that we're seeing patients are self-administering, but most importantly, they're self-administering at the right time, which is within the 30 minutes of onset of the symptoms. Early injection to save muscle is extremely important, and we see patients are following that. The next step is for them to take themselves to the hospital after that, to call for an ambulance and so on. And they are well trained, and they are doing that. So they are following the process. Things are going well from that standpoint.
And then from a safety point of view, I think we've had 13 DSMB events until now and always continue as unchanged, right? And from a blinded standpoint, we are not seeing any safety concern at this point. But again, we'll have to wait and see the full data set, unblinded. But so far, so good, I would say.
Excellent. And maybe just the last question on the new product flow. Just beyond these three assets, you think about the new launch portfolio and pipeline. What else are you excited about that we should be thinking about here?
Outside of what we've discussed, you had some, but I think for me, we've had significant successes in our complex generics portfolio last year, so I look forward to seeing that come to market, and I understand it's going well so far, but also, we have a number of additional complex injectables. I would say ferric carboxymaltose is probably the largest one next year, and we're on schedule to get that approved, so from the base business point of view, I think the complex generics look good. I would say that we're particularly excited about pitolisant in Japan. You know, Wakix in the U.S. is doing quite well, so we anticipate that it should do well in Japan as well, and we have a number of other pipeline assets like Nefecon for treatment of IgA nephropathy in Japan. We anticipate the data early this year.
We're also very excited about the opportunity there for Japan. It's a full pipeline, and I think so far we've delivered what we said we were going to deliver, and we look forward to doing that again this year.
He didn't leave me any room to talk about other products. I was excited about.
No, I know. He took them all.
He took them all.
He took them all.
The only other two that I would say that I think are on our radar that we think are going to be important are Effexor GAD in Japan. First product of that indication in Japan, I think, will be a very positive medication for Japanese society and for Japanese patients. And then also what we call Gwenlow, but the low-dose estrogen patch, which we should be launching relatively soon. I think we're excited about that. We've got substantial position in a different patch, but the low-dose patch, I think, has the potential to have an impact as well. So a large patch.
The last one that I think is quite important is in eye care or presbyopia. We got strong data at the end of the year. We filed, and we are anticipating approval this year. I think there's a significant opportunity there as well, especially in light of all the dynamics that happened recently on the market. So.