Sandoz Group AG (SDZ) Earnings Call Transcript & Summary
September 5, 2024
Earnings Call Speaker Segments
Thibault Boutherin
analystSo good morning, everyone, and thank you for joining this session of the Morgan Stanley Global Healthcare Conference. I am Thibault Boutherin, I'm part of the European pharma equity research team based in London. Before we start, I need to refer to some important disclosures. Please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So for this session, I am delighted to have with me Richard Saynor, CEO of Sandoz; Remco Steenbergen, CFO; and Keren Haruvi, Head of North America. So thank you very much for joining us today. So we'll start -- we'll do Q&A very quickly. But before we start, maybe, Richard, would you like to start with some introductory comments and maybe come back on some of the key takeaway from your recent strategic update.
Richard Saynor
executiveThank you. First of all, thank you so much for the invite. It's a pleasure to be here. Look, it's pretty much a year to the day that we were left in New York and London with our first Capital Markets Day. I guess since then, clearly, we spun the company. We've delivered strong momentum. I think 12 straight quarters of growth. We delivered 7% growth in our first half. But actually, the thing I'm most proud of is really the filings and approvals that we committed to this time last year, pretty much now every one of those products, we've now filed many of those products, now we've launched and start really now moving the momentum, particularly the biologics business, and I know there'll be questions about the U.S. evolution but particularly proud how Keren and the team have done a phenomenal job turning the U.S. business around and delivering growth, particularly in biosimilars. Ultimately, we operate in a very attractive market. Today, it's about $200 billion, but there's nearly $400 billion of LOE looking towards us. There's something called GLP-1s that may not be coming off. No doubt we'll talk about those a little bit today. But also a significant number of biosimilars. And I think we positioned ourselves now as the world's leading biosimilar company, which is a strong foundation to go forward. So a lot has happened in our first year but very pleased and very proud of what we've achieved.
Thibault Boutherin
analystPerfect. Thank you for the introductory comments. And let's jump straight into biosimilars. And everyone is, I think, interested and excited about what's happening with biosimilar, Humira in the U.S. in particular? So if you could give us an update on the progress you've made here, maybe starting with the sales from your private label deal with Cordavis, the subsidiary of CVS, it has done incredibly well. So the question is how much more room for growth there is here in terms of volume? Or has this channel already reached some level of maturity already?
Richard Saynor
executiveI think Keren, that's a question for you.
Keren Haruvi
executiveThank you. Yes. So first of all, we are very pleased from our collaboration with Cordavis. It was a unique opportunity to be the first company to bring private label into the United States and really to open access to patients. And we launched in July 2023, and we didn't see too much pickup. And definitely, by doing this, we saw access now in the market, there is 19% access to biosimilar, again, based on the public IQVIA data. And 80% of this 19% is hold by Sandoz. So to your question on our ability to grow the volume, I would say from a pure CVS perspective, we probably achieved more or less steady state in the specific segment, the commercial segment where we are playing. Definitely, there are other opportunities with CVS and their other books of business. But also we see an opportunity with other payers. So again, as you know, CVS is the only payer so far to displace Humira. [indiscernible] announced with Cigna that they will display Humira in some of their plans in 2025. Optum announced yesterday that they will do the same. Again, in Cigna, we are going to be in the formulary, so we'll continue to drive growth there, and we're looking at other opportunities. So I would not say that we got to where we want to, as an industry, 19% is not enough. So definitely, there is still room for growth.
Thibault Boutherin
analystPerfect. And zooming in a bit on this private label deal, I think one of the key questions we have is what is the agreement with Cordavis? I think you said it's a multiyear. So if you could come back on the stability we can expect from this channel? And also, if you could maybe tell us if you have a sort of first right to renew option on this contract or some sort of tools to renegotiate down the line and be maybe first in line to kind of continue this contract?
Keren Haruvi
executiveYes. So first of all, we did share that the agreement with Cordavis is a multiyear agreement. So it was not just a 1-year agreement. I would say that both Cordavis and us are very happy with the outcome. Cordavis kind of announced that they had more than 90% conversion. So definitely a little success. I would say we both committed to patients. At the end of the day, it's a chronic disease. Patients are getting used to the device, et cetera. So there is a name from both companies to continue and support patients in the most kind of consistent way.
Thibault Boutherin
analystOkay. That's very helpful. And then just talking maybe a little bit about ex U.S. for biosimilar Humira. How sustainable the growth is here because you've done very, very well? I think you're clearly one of the leaders, if not the leader on biosimilar Humira Express, so how should we think about that? And how much more room from growth that is here as well?
Richard Saynor
executiveI guess, to, I mean, look, Europe was growing mid-teens for the last 3, 4 years and continues to do so. You've got to remember that a lot of patients who weren't able to access biologics because of the price points. And I think even in Germany, it was about 5 years from diagnosis to treatment for rheumatoid arthritis. So that time is coming down. So clearly, the patient pool is expanding. And also, we're now bringing these products more and more to the other of the international markets as well. So it's not static. It's not like everything launches at the same time and you get complete conversion. So you see steady momentum. And I guess the best example of that is Omnitrope. I mean, we launched onto 18 years ago, and it's still growing. So today, we're the world's largest supplier of human growth hormone. It's a business that's very attractive, continues to grow. And I think it still has potential to continue. So I think it plays to the -- really the main difference between a lot of the biologics and simple molecules. And then when you look further forward, a drug like denosumab, huge potential for growth, given the indication for osteoporosis and then how you access those patients and then they're frequently on these drugs for a very long period of time. So I think there's a lot of room to grow.
Thibault Boutherin
analystUnderstood. So consider growth ex U.S. and going back to the U.S., a similar question, but I guess the question is on U.S. biosimilars, I think what we've seen in the past for some other biosimilars is a sort of time to peak of maybe calling it 2 to 4 years, and then we started to see a decline as the price erosion were kind of more than the volume growth. So for Humira, in particular, you mentioned the room you have to grow in some other channels outside of Cordavis and CVS. So how should we think about the shape of U.S. biosimilar Humira? And could it be consistently growing? Or should we also expect the sort of bell curve in terms of reaching pixels and then expecting an erosion?
Keren Haruvi
executiveFirst of all I would say that 2 to 4 years is probably more kind of a medical benefit product. That's what we saw. And you are correct that once you kind of get to your share, we start to see the ASP kind of erosion, right? And the least balance between volume and value that you need to kind of manage consistently. So I would say in the medical benefit, definitely we see 2 to 4 years to peak, and we do see a great penetration, 80%, I would say, share for biosimilars if you look at most of launch in this space. In the pharmacy benefit, it's different. Again, this is the first, honestly, a pharmacy benefit launching biosimilars. So I would be careful and say exactly how it would behave. But as I shared before, we do believe that probably it will be -- we achieved probably the share that we anticipate in the in the CVS book of business and then we'll see how the others will behave. There are also other kind of factors, including what PBMs will do with other brands in the category, et cetera. So it's not just about the conversion. It's also how the overall market will behave in the other market.
Richard Saynor
executiveAlso don't forget there's opportunity to gain. The most insurers have treatment protocols, how those protocols evolve because the ultimate over time, the cost of these drugs comes down and they become more accessible. So there again, the potential pool of patients who aren't receiving products that could be receiving products over the medium term.
Thibault Boutherin
analystVery clear. And just maybe focusing a little bit on the specific opportunity within the U.S. market. Recently, as you mentioned, Express Script announced that they would remove branded Humira from the label starting in January '25. They have their own private label deal, at least kind of Cigna, which is the parent organization as the private label deal with the Alvotech, Boehringer, but biosimilars of Sandoz still on the preferred formulary. So how should we think about this? And how much upside do you see in that formulary exclusion opportunity where Cigna is basically removing branded Humira?
Keren Haruvi
executiveYes. I think it's early days. We definitely think there is a significant opportunity for us, and we are very pleased that we remain on formulary. I would say you need to think about it at the end of the day in the chain and the control that the PBM has overall. And I do think that there are a lot of other specialty pharmacies kind of working with Cigna beyond Accredo. So we do think there is a significant opportunity for us to achieve share. And I think the fact that we were early to the market, early with our private label, we do have advantage. We do have already many patients on this product, and I don't think that they will move now to the private label. So the part of being first really helps us to make sure we have those patients.
Thibault Boutherin
analystThat's clear. And switching to biosimilars Stelara. So you have visibility on the launch date in the U.S. next year. Are you in discussion already for a similar private label deal similar to what you did with Humira? And could there also potentially be a provider for multiple PBMs rather than having sort of kind of exclusion deal with -- exclusives deal with specific PBM on Stelara or even other biosimilars in the future.
Keren Haruvi
executiveYou want me?
Richard Saynor
executiveGo for it. Yes. You get all the difficult questions.
Keren Haruvi
executiveYes. So first of all, we are very pleased that we have now also a biosimilar to Stelara, ustekinumab, as you mentioned, in our portfolio. It's a new addition, and we'll be able to launch in the first wave with other companies in Q1 2025. If we anticipate a market to go in a similar direction, I would say probably yes. We -- just also yesterday, again, Optum announced that they will do it for their private label with ustekinumab. We are not sharing yet what will be our commercial approach. We believe it's too early to share. But definitely, we will see similar kind of dynamics in the market.
Thibault Boutherin
analystVery well, that's clear. Moving a little bit on the U.S. generics. I think the sales declined a little bit in H1. Can you comment on the price dynamics in this market, how your pipeline can help compensate for this in the future? And some color of you mentioned generic launches that you would expect to launch in the U.S. in the second half of the year. So a bit more maybe granularity here if you can?
Keren Haruvi
executiveYes. So I'll start from the price erosion perspective, we're not sharing it by region but we did share the overall the global kind of price erosion. And it's pretty consistent to what we see in the past. So I don't anticipate to see specifically this year more price erosion. And I always like to say that markets are not eroding. It's the specific products. And if you look at our portfolio in generics, it's very mature. I also always say that prices in the generic space are, to some extent, too low. So I don't think there is a lot of room and if you look at our portfolio for significant erosion. So that's first. Now where the opportunity is coming from launches, we just had our strategic day earlier this week, and I shared that in 2024, we had only 5 launches. So we are still suffering from historical gap from our decision to divest a significant part of our portfolio in 2018. Again, it didn't come into fruition, but we didn't invest in the pipeline. So we did share again earlier in the week that we do have 70 products that are expected to launch in the U.S. until 2028. And we believe that this portfolio is significant enough to offset our erosion in the market. And look, I want to put it out that we are not looking to be a leader in the generic space. We want to be a sustainable player and we'll continue to bring products where we believe we can sustainably supply the market but we are not aiming to be a leader in this space.
Thibault Boutherin
analystThat is clear. And moving out of the U.S. and focusing on Europe, you launched biosimilar Stelara very recently in Europe. And right now, I think it's just you and Alvotech, Teva launching this product. So it's obviously very early. But if you could tell us a little bit about the reception, are you seeing any particular obstacles to launch or any early successes? And any color you can give us here?
Richard Saynor
executiveNo real obstacles. I mean we have the full portfolio of strengths. So I think, again, that makes it relatively unique. And also bear in mind, we are the leading -- one of the leading immunology companies in Europe anyway. So our ability with relationships with payers, prescribers, advocacy groups is very, very strong. And this has been an extremely well-received launch and clearly, I guess, our next sales update after Q3, we'll be able to give more details.
Thibault Boutherin
analystVery well. So maybe we do a little bit of a pause on the product question and talk a little bit about the margins. I think margins have come in to debate at the second quarter earnings, you did 17.5% margin -- EBITDA margin in the first half, and you need to achieve around 22.5% in the second half to kind of reach your margin guidance of around 20% for the year. So if you can remind us of the kind of different elements of this margin position and also an update on the cost-saving plan that is part of achieving this margin.
Richard Saynor
executiveRemco?
Remco Steenbergen
executiveNo, thank you for the question. Of course, it's a very steep improvement from first half to the second half. But you have to consider in a couple of elements in here, is one that's also Keren mentioned, the price erosion is relatively flat going from the H1 to H2 as well the cost erosion, which came in the system in the second half of last year, which was quite significant, was up to 10% of the total cost of goods sold. That has also come to a very, very low level. And actually, on the manufacturing side, we're actually seeing some benefit now coming in. The big 3 drivers of the increase from 17.5% to the much higher number in the second half, they come from the whole mix, further mix improvement. You have seen that the biosimilars have been growing quite a bit and that growth of -- over-proportional growth of biosimilars in H2 versus H1 will continue. So you can do your own math because the margin is, of course, much better there. The second element is that the absolute sales level in the second half year is quite a bit higher than it is in the first half. So there comes a natural leverage on the whole cost base. The last element is that the whole transformation program is now starting to bring the real cost savings in for that, we expect about $50 million in the second half of this year, which is part of the top line would be already around 100 basis points of the improvement. So those 3 -- are the 3 elements we are counting on for the second half year. But of course, it's -- to say, it's a very steep increase, correct, for this part. We also often get a question, can we extrapolate it then into next year and the years after, and then you have to do the margin very quickly get to 100%. of course, that is not the right way of doing it. There were particular elements, which in consideration. But still, for this year, the 20% would be reached, and we still have the 24% to 26% by '28, you can still count it, of course, every single year we want to improve. But they have different elements, which then that progression will influence. But don't extrapolate this 5% just like that.
Thibault Boutherin
analystThat's clear. And then the cost saving plans, can you just give a little bit more granularity on what are the pockets of savings you're making in terms of different functions where you saw opportunities for cost savings?
Remco Steenbergen
executiveI think what the company has done splitting off of Novartis is clearly looking what will be much more fit for purpose. So the layers in the organization have been reduced in certain groups, also the number of people have been reduced. It's basically everywhere other than direct sales force. So there we have said no, because the sales force, we want to grow down to leverage but there are no reductions there. But then it's in all the functions. It's an HR, it's in finance. It's also on the operational side. For this, we plan, which we also laid out a restructuring cost of about $350 million, $140 million was taken in the first half of this year. Depending on how negotiations go with the unions, we would have a similar amount in the second half of this year. It could be that a little bit goes into next year. And then the run rate of savings should come to around $200 million per year, but that's by '26 million because we still have to work on through '25 to come in '26 to that level but it's across the board.
Thibault Boutherin
analystThat's clear. So switching to one of the key topics of your strategic update, and you mentioned it's obviously a GLP-1 opportunity where people are getting excited. So if you could talk a little bit about how you -- I mean you [indiscernible] strategic update but if you can give us a view on how you're thinking about addressing this market. Obviously, the demand is massive and there are some, I would say, constraints in terms of the capacity, supply challenges. So if you could kind of give us how you're thinking about the GLP-1 opportunity?
Richard Saynor
executiveI will do. We get a lot of questions. And I think partly everyone sort of sort of square this disconnect between the amount of CapEx that the originators are spending versus the amount of CapEx that potentially we would need to spend and how we view the market. First of all, I put to remind you, we're an injectable company. But certainly, if you look at our biologics business, so we're investing in capacity for injectables anyway. So that's just an important how that add back your mind. The way I think about GLP-1 is really in 3 phases. You've got '26 to '30, which is really -- Canada is the first market to [indiscernible] to be launched around 2026. That's the second largest market in the world, but it will be interesting how that market will evolve. I have no idea. But certainly, we have a partner, we filed, and we're confident we would be at market formation when that market opens up. We're anticipating it in 2026. In parallel to that, then you've got a number of emerging markets Brazil, Turkey, et cetera, et cetera, all start coming off '26 onwards. And the potential in those markets in terms of access is huge. I think as we commented the other day, market like Brazil, it's actually predominantly dentists to prescribe a lot of these class of drugs because it's in terms of those are the patients who are currently accessing it. So how that's going to evolve. And so really sort of that -- the first wave with we will use a mixture of in-house capacity and third-party capacity. We don't manufacturing API. We have partners with the API. We're not constrained about -- concerned about the capacity. I have no idea what the forecast would be. I could come with a very big number or a slightly more modest number but it's going to be super interesting. Then as you get into sort of the 2030 is really when the regulated markets start falling. Now I can fully expect the originators will do everything in their power to make our life difficult. That's part of the game. So I can see the U.S. and Europe starting to come down for semaglutide 2032, 2033, that sort of time frame. And then tirzepatide, majority doesn't come off patent until, I think, 2035. So this is a 10-year journey, at least before you even then get into, are we going to migrate to the next generation? Are they going to migrate to all? And in terms of our CapEx needs, it's going to be in the hundreds of millions, not the billions because ultimately, we're investing in full finished capacity and injected capacity, which predominantly, we're going to have to ingest to invest in any way as we expand the biologics business. So I think super excited, it's not in our guidance in terms of our numbers. It's clearly an opportunity and one we would intend to be a serious participant. But that's really how I see it. I hopefully answers most of your questions.
Thibault Boutherin
analystIt does. It's helpful. So also a supply question but this time more on the biologics side of the business because the feedback we get from talking to CDMOs is that there is currently some supply constraints on large-scale biologic capacity, which is, to my understanding, the type of capacity would need for biosimilars and I'm talking about the industry in general. So with your biosimilar portfolio growing at a global level, multiple new launches planned, you will definitely need additional capacity in the coming years. So if you could just talk us through your strategy for supply, yes, generally speaking, to [ supply ] your portfolio.
Richard Saynor
executiveYes. I mean today, predominantly, Novartis is still one of our main suppliers. That's on a long-term agreement, and it's on a cost-plus basis. It's not in terms of a CDMO relationship. So we have a very good cost of goods. In fact, we just expanded the debt capacity around the initial MSA agreement to build more capacity. Novartis clearly like that, drives strong recoveries, and we're happy that they are supplying us. At the same time, we're investing in Slovenia. That plant should be completed by 2026 and then probably 18 months, 2 years of tech transfers in 2028. That will give us access to improved COGS and clearly additionally a step change in terms of capacity. At the same time, we're working with a number of CDMOs. And also clearly, we could continue to use Novartis even when Slovenia is up and running. So that doesn't necessarily terminate that relationship. And on top of that, clearly, we have the potential partnership with just Evotec to in-license or bring their POD technology, which could be a game changer in terms of both capacity and yield and ultimately cost of goods. So I think we've got a multipronged strategy that gives us security of supply. I mean, the biggest problem that I have in this industry is really probably with the exception of natalizumab, we never supply 100% of any market. So if one of our competitors' sites gets blown up in a volcano somewhere, for argument's sake, how do I fill that capacity overnight. It's very, very difficult because you're filling -- your planning capacity particularly 18 months, 2 years out. So building some flex, I think it's also important.
Thibault Boutherin
analystThat's clear. And in connection with all of this, you mentioned a bit about CapEx. You have your target of $2.3 billion CapEx plus hundreds of millions of potentially depending on the GLP-1 opportunity. But even excluding GLP-1, is there some flexibility on these numbers if you start to see that growth is accelerating maybe beyond your plans or some biosimilars taking off faster than others? Kind of how you're thinking about this initial target that you set and the flexibility around here?
Remco Steenbergen
executiveI think in the plans which we have for the CapEx, correct, there's about $2 billion for the coming years, which for a significant part is related to the further growth, particularly in Slovenia, the own site for biosimilars, we set up progressively over the years, we will further grow this, correct? And that's partly and the horizon -- it's partly outside of horizon but we believe that out of the free cash flow we have, we can all finance this.
Thibault Boutherin
analystThat's clear. And still related to capital allocation. Maybe if you could tell us a little bit about business development and M&A. You've done some small, I would say, in-licensing deals around here. But how would you frame, first capital allocation priority and second, how you're thinking about business development to supplement your growth?
Remco Steenbergen
executiveNow with the separation in October last year, right, our first focus is really internal getting the transformation done, getting the organization really spotless, correct, in terms of his operation model. I think that's clearly #1 and everyone is there. Clearly, on the biosimilar side, we have disproportional growth on this and also ensuring that all our development on the longer term is in that direction and driving the mix. Also within generics, I would say, is the first one from a business perspective. Within that portfolio, there are opportunities, of course, for M&A, and we will selectively look in M&A opportunities. At the moment, we will be looking at, say, 1% of the inorganic growth a year on average, roughly through buying parts of new portfolio, anything bigger than that, that it's not on the radar screen at this point in time.
Thibault Boutherin
analystThat's very helpful. Coming back maybe on some [indiscernible] questions. Richard , you mentioned the success of Omnitrope and your market share keeps going up, 38% of the last update. So how high can you go here? What is the outlook for this product? And then how much room do you have to grow on this part of the market?
Richard Saynor
executiveLook, I mean, some of that -- clearly some of that success has been down to the originators, deprioritizing supply to prioritize GLP-1s, I see no signal for them really coming back in material terms for the next -- so staying for the foreseeable future. And then clearly, even in the U.S., one of the other players is now formally pulled out as well. So I think it's leaving a space. Generally, once kids start this therapy, they generally stick with it until they reach adulthood. So those patients are pretty sticky. So I would anticipate modest incremental growth going forward.
Thibault Boutherin
analystUnderstood. That's clear. And you mentioned as well, natalizumab, Tyruko. So you gave us an update on the launch in Europe and how encouraging it is. Maybe starting here, do you see any kind of uptake or friction in the market in Europe? And I guess the problem with multiple sclerosis, in particular, you have so much innovation in this space. I think even before you came in, this product was already starting to decline in volume. So could you reintroduce volume growth here? How are you thinking about your biosimilar in the product of innovation in this condition?
Richard Saynor
executiveWell, still a lot of patients who want to access this product, the government or it's not available to them in Europe anyway. So I still think there's an opportunity as pilot of the portfolio of therapies for multiple sclerosis. The acceptance of these products has been very good. In some of the Nordic markets, we've taken significant proportions of the shares through national tenders. And in individual markets where it tends to be more physician led, we're well accepted, payers like us, patient advocacy group support us. So I think I don't see any concern. Ultimately, look, this is never about a big volume strategy. This is a relatively modest product. It's only a couple of billion dollars globally. But what's important is we're never likely to see a competitor. So how are we going to continue to work with payers in this space. It's a complicated product with the JCV assay and the REMS program. But certainly, very pleased with where we are today.
Thibault Boutherin
analystThat's clear. Let's talk also a little bit about biosimilar Humira and the timing here. So you have -- you had an approval in the U.S. last month for biosimilar Humira -- sorry, Eylea. I think it's right.
Richard Saynor
executiveToo many biologics.
Thibault Boutherin
analystSo can you just remind us what are the key changes from an IP perspective and the timing to get the resolution on that for biosimilar Eylea in the U.S?
Richard Saynor
executiveLook, we're pleased we've got the approval beyond that. I'm not going to comment other than say it will between now and 2027. Clearly, we'll now go through the usual patent dance, which I'm not going to disclose anything. And so we'll see. I mean, clearly, I'm pleased we've got the approval. I look forward to bringing the product into Europe, I think late 2025, early 2026, that sort of time frame. And clearly, we bought similarly in the U.S. to give us a platform and a bunch of specialist sales organization used to dealing with physicians in this space. So we're well positioned when we launch to perform but we will see.
Thibault Boutherin
analystThat's clear.
Richard Saynor
executiveIs that Keren?
Keren Haruvi
executivePerfect.
Thibault Boutherin
analystAnd obviously, the branded originators are working very hard on trying to switch patients from the low dose 2 milligram of Eylea towards the high dose version of 8 milligram. And so how is that -- how is the dynamic potentially impacting or slowing you down? And do you think you could convert high-dose patients to low dose? Or do you feel it's going to be complicated here?
Richard Saynor
executiveIs U.S. specific, Thibault?
Thibault Boutherin
analystNo, Europe as well, I think...
Richard Saynor
executiveI'll pass comment about Europe and then Keren U.S. I mean I think, look, this is still a large market. And again, there's a cost point. So when we look at this, we still see this as a significant opportunity. Any quick conversion from other products, well, not just necessarily the same drug class. So I think it's still very attractive. And I think from the U.S...
Keren Haruvi
executiveYes. I would say, first of all, similar. Also, of course, it will be dependent in different factors like reimbursement, et cetera. But we do see a lot of products that have high dose of subcu options, a long-acting and you still see a very consistent share for the product. So we do believe that there is a significant market. Definitely, some of the patients would move but not all of them. And also, we need to remember here, you inject something to the eye. So we do believe that physician would look patient-by-patient and we'll decide clinically what they want to do and then it will follow the reimbursement model.
Thibault Boutherin
analystVery clear. And still on Eylea, at least one biosimilar company has disclosed that they're working already on the high-dose formulation. And so is it something you're interested in? Do you think it's even worse it? What is your kind of thinking about developing potentially a high dose version?
Richard Saynor
executiveIt's something we would disclose if and when we get the Phase III trial.
Thibault Boutherin
analystUnderstood. Okay. And maybe in the time we have left, last question on biosimilar interchangeability in the U.S. That's something that has been a debate before. And you have clearly proven with Humira that you don't need interchangeability status to be successful, that's been clear. But that being said, when Cigna did their private label deal, they clearly mentioned interchangeability as one of the key reasons why it choose by our partners. So how you're thinking about this going forward? Is it something that you could work on for future biosimilars? Or do you think it's still not that relevant in the U.S.?
Richard Saynor
executiveAnd from my point, and then I'll let Keren comment. I think it's completely relevant. I mean, ultimately, we've got 80% share of the open 20%. With -- now to be fair, one of our presentations is interchangeable. But the way the FDA is originally characterized interchangeability to me makes no sense whatsoever. It doesn't mean product A and B or interchangeable, see -- it makes no sense. Now clearly, denosumab is interchangeable. We've got designation there. So if we can get it through the filing process, why not it does, and it does no harm. But honestly, I think now the -- I mean I was with the head of the FDA a couple of months ago. And clearly, they're moving much more to a European lens than in a sense, once you've given them an approval, it is interchangeable with the originator, which makes far more sense. So I just think, look, -- and that's been sort of my perception. I don't know what your experience is?
Keren Haruvi
executiveYes. I fully agree the FDA, first of all, and we definitely see that the kind of their paper and where they are going, and we agree with their position. I would say that interchangeability is one factor, like going with many others that will be relevant and it really depends on the stakeholders. But as Richard said, our ability to be successful and win even the Cordavis kind of process, we didn't have interchangeability back then. By the way, today, we do have on our 10, 20 and 80 for the prefilled syringe. But in reality, it didn't matter for the switch. What really matters is the device that we have, the experience that we had outside the U.S., the patient service support that is very similar to what the branded company gives. So we do feel that there are many factors that make a difference and interchangeability is one of them. But there is also something you think about interchangeability, it gives the ability to the pharmacy, right, to change the product without talking to the physician. When you talk about a patient, which is chronic patients, they usually want to hear the advice of their physicians. So picking up the phone, get them on board and then communicate it to the patient, we actually found it pretty useful.
Thibault Boutherin
analystThat's very, very helpful. And we're coming up to the end of the time. So thank you very much for taking the time today and be with us. We appreciate you.
Richard Saynor
executiveThank you so much. Thank you for your question.
Keren Haruvi
executiveThank you.
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