Good morning, ladies and gentlemen, and welcome to the Sandoz call today. I'll now pass on to Karen King, Global Head of Investor Relations, for her opening remarks.
Hello everybody, welcome to Sandoz's First Quarter 2024 Sales Results. Earlier today we issued a press release summarizing our sales performance in the first quarter and published a supplemental slide presentation on our website, which we will follow on today's call. You can find all these documents in the Investor Relations section of our website at investors.sandoz.com. Joining me on today's call are Richard Saynor, our Chief Executive Officer, and Colin Bond, our Chief Financial Officer. As a reminder, this will be Colin's last quarterly results call. Remco Steenbergen, our new CFO as of July 1, will be joining us on our half-year earnings call on August 8. Our press release presentation and discussion will include forward-looking statements. You should not place undue reliance on these statements.
Such forward-looking statements are based on our current belief and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. In this document, we present certain non-IFRS measures. These non-IFRS measures may not be comparable to other similarly titled measures of other companies and have limitations as analytical tools and should not be considered in isolation or as a substitute for the analysis of our operating results as reported under IFRS. Non-IFRS measures are not measurements of our performance or liquidity under IFRS. They should not be considered as alternative to profit for the year or any other performance measures derived in accordance with IFRS.
For discussion purposes only, in today's presentation, sales in this document refer systematically to net sales to third parties, and our comments on growth are expressed in constant currencies. With that, I'll now turn the call over to our Chief Executive Officer, Richard Saynor.
Thank you, Karen, and it's a pleasure to welcome you to our first quarter 2024 sales results. We saw a strong start to 2024 thanks to the relentless effort of our more than 20,000 employees. Our sales grew at 6% in constant currencies, driven predominantly by our biosimilar business, and I'm also delighted that we saw growth in all three regions. We also completed the acquisition of Cimerli ahead of our anticipated timelines, and we continue to show progress on our manufacturing investments with the opening of a new antibiotics production facility in Austria to increase our capacity for essential medicines. This puts us in a strong position to deliver on our full-year guidance. The first quarter was our 10th consecutive quarter of top-line growth.
Our biosimilar business grew 21%, driven primarily by the ongoing launch of Hyrimoz in the U.S. and the acquisition of Cimerli, which added one month of contribution during the quarter. Our generics business was up 1% despite a particularly strong first quarter last year in 2023. All our regions contributed to growth, a testament to the strong execution across the organization and the ability for us to use our scale to deploy our portfolio. Now let's turn to the business. Generics grew 1% on a constant currency basis in the first quarter. The generics experienced volume growth from solid demand in our base business in Europe and international. Growth was also driven by the acquisition of Mycamine and sales resulting from the transfer of mature brands from our former parent. This was partially offset by three items. First, the impact of apixaban.
If you recall, apixaban sales peaked in the first quarter of 2023, and due to IP litigation, we had to withdraw the product in the Netherlands in August of 2023. As such, this created a year-over-year headwind, and we're still waiting for the final decision from the Dutch court, which will determine our ability to relaunch this product in this country. Secondly, we had an exceptional cold cough season in the first half of 2023 and a more average season in 2024. Thirdly, our North American generics business declined in the first quarter due to the timing of new launches, which has skewed to the second half of 2024. In the first quarter, we inaugurated our new antibiotic facility on our main production site in Kundl, Austria.
The EUR 50 million investment in the plant and it will provide operational efficiency means that we can now manufacture 240 million packs this year. This represents a 20% increase in capacity over 2023 and more than double the volume of 2021. The automation and innovative technologies allow the production of 1 billion more penicillin tablets, a doubling of output for key pediatric formulations. This is in line with our ambition to serve more patients with critical antibiotics and our commitment of EUR 250 million invested in what is today the last vertically integrated antibiotics facility production in Europe. Our biosimilar business grew 21% on a constant currency basis in the first quarter, driven by the ongoing launch of Hyrimoz in the U.S. and the acquisition of Cimerli. This acquisition builds on our leading ophthalmic platform in the U.S. and lays an even stronger foundation for future product launches.
Omnitrope continues to experience strong customer demand in a generally constrained supply environment, and we expect this situation to continue for the remainder of the year. Tyruko, or our biosimilar natalizumab, is gradually contributing to sales in Europe. At the end of the first quarter, the product was available in Germany, Spain, Norway, and Finland. In April and May, we launched Tyruko in five additional markets across Europe. We're also progressing well on other key biosimilar value drivers. During the quarter, Wyost and Jubbonti, our biosimilars of denosumab, received both U.S. FDA approval and a positive CHMP opinion in Europe. Wyost and Jubbonti are the first and only FDA-approved biosimilars in the reference medicine. Last week, we announced the agreement with Amgen that resolves all patent litigation related to our U.S. denosumab biosimilars.
This clears the path for a launch of Wyost and Jubbonti on May 31, 2025, or earlier under certain circumstances. In April, Pyzchiva, our biosimilar ustekinumab, received European Commission approval. Pyzchiva is the first biosimilar ustekinumab approved in Europe and strengthens our immunology offering. We're targeting a launch in Europe in the second half of this year. Now, let me provide more color on the Hyrimoz launch in the U.S. In the last two quarters, I highlighted the tremendous effort of our U.S. team to put us in a leading position in terms of market access and payer coverage amongst adalimumab biosimilars, and that we have preferred access to 65% of CVS Caremark's commercial templated lives.
I also discussed how we are uniquely positioned by offering the only adalimumab biosimilar with the same dosing options of Humira, two presentations to ensure broad access for patients, and a vertically integrated supply chain offering reliability and consistency. These efforts are now starting to shine through. Biosimilars have now 15% of the adalimumab market, including both originator and biosimilar products, and Sandoz has secured the leading share position amongst biosimilars with over 80% of total prescriptions, according to IQVIA data, as of the week ending April 26. With this, I will hand over to Colin to provide more details on the sales performance and discuss our guidance for 2024.
Thank you, Richard. I'm pleased to be with you today to discuss our first quarter sales performance. As Richard mentioned in his opening comments, we had a strong start to the year with sales growing 6%. Volume contributed 10 percentage points to the growth, while price erosion of 4 percentage points remained below prior year. FX had a limited impact on our sales versus prior year, with a negative 1 percentage point coming mainly from the depreciation against the U.S. dollar of a number of currencies in our international region, partially offset by the appreciation of the euro and Swiss franc. With another quarter of strong double-digit biosimilar growth, biosimilars increased as a proportion of total sales to 25% compared to 22% last year.
Our regional sales mix remains relatively stable, with over half of our business in Europe, where we hold a strong leading position, and the remainder divided between the North America and international regions. Let me now deep dive into our sales by business and by region. Starting with sales by business, generics remained in line with prior year levels. Solid volume demand in Europe and international was partly offset by the impact from the withdrawal of apixaban in the Netherlands in August 2023, an exceptional cough and cold season in the first half of 2023, and the timing of launches in the U.S. Biosimilars delivered very strong growth of 21%, primarily due to the ongoing launch of Hyrimoz high concentration formulation, the acquisition of Cimerli, as well as continued strong demand for our first-ever biosimilar Omnitrope.
Regarding Hyrimoz, we continued to supply Cordavis as part of our unique multi-year agreement and started to see an acceleration in sales of our own branded Hyrimoz and unbranded adalimumab following the displacement of Humira from CVS templated commercial formularies on the 1st of April. Moving to the regions, all three regions delivered solid performance in the first quarter. Europe grew 2% despite a very strong first quarter of 2023. Gains from generics volume and continued strong growth for Omnitrope were partially offset by the year-over-year impact from the withdrawal of apixaban and the exceptional cough and cold season last year. North America grew 6% and benefited from strong biosimilar performance, primarily from the launch of Hyrimoz and the acquisition of Cimerli, which closed ahead of anticipated timelines in early March.
This strong growth was partially offset by a decline in the U.S. generics business due to the timing of launches. While we did not have any material launches in the first quarter, we expect to see full-year growth in our North America generics business as we launch more generics products in the second half of the year. In addition, we also had a one-time year-over-year growth- to- net adjustment, and the quarter was impacted by the timing of shipments. Our third and fastest growing region, international, was up 12% due to the strong volume growth across the businesses, with contributions from Mycamine and favorable pricing dynamics. Moving to our full-year 2024 guidance. On the back of the Q1 sales performance, we are confirming the guidance we provided during our full-year 2023 earnings call in March. Net sales to third parties are expected to grow mid-single digit in constant currencies.
Core EBITDA as a percentage of net sales is expected to be around 20%. I would like to reiterate the phasing of the core EBITDA margin in 2024, as there will be a significant increase in the second half of the year versus the first half. This is due to favorable mix as biosimilars become a larger proportion of our sales and the timing of operational improvements and transformation initiatives, which will accelerate in the second half of the year. With this, I will hand it back to Richard.
Thank you, Colin. A couple of milestones this year regarding biosimilars are the launch of Tyruko in the U.S. in late 2024. The FDA responded to our JCV assay submission, and I've asked for additional information. On top of this, we expect to launch Pyzchiva, our biosimilar ustekinumab, in Europe in the second half of the year, as we previously disclosed. Regarding our next financial update, we will host our half-year annual results on August 8, 2024. Prior to handing over to the operator, I would like to express my sincere gratitude to Colin for all his last earnings call with Sandoz. It's been a pleasure to work with you over the last few years. You've made an incredible contribution to the company, and I've been able to learn a lot from you through the spin and in the early months as a standalone company.
I wish you all the best in the new chapter ahead. With this, I will ask the operator to open the lines for Q&A.
Ladies and gentlemen, we will now begin our Q&A session. If you have a question, we ask that you please use the raise hand function at the bottom of your Zoom screen, or if you have dialed in, please press star 9 to enter the queue. Once your name has been announced, you can ask a question. If you want to withdraw your question, please lower your hand using the raise hand function in the Zoom app, or via telephone, press star 9. Our first question comes from Emmanuel Papadakis at DB. Please unmute your line and ask your question.
Thank you for taking the question. Perhaps I'll kick off with one on Hyrimoz dynamics. Maybe a couple there. You'd be very helpful if you could talk a little bit about the relative economics of direct sales versus those sold via the partnership you've struck with CVS Cordavis, i.e., your margins comparable. And then some of the volume outlook from this point forward. Is there a ceiling in terms of the percentage of covered lives that you expect to reach over the coming months? And any thoughts you have in terms of the pending Cimerli launch, in particular, would be of interest. Is there any risk of volume reversion once we have an interchangeable available? Is there any overlap with the volume that will be covered by the Cigna Quallent deal struck for that biosimilar? And then maybe a quick question for Colin.
Colin, just congratulations on your brief tenure as CFO. Perhaps you could give us some parting comments in terms of the relative drivers for the mix. You mentioned DH2 skew and EBIT. To what extent is it the biosimilars inflection versus the cost opportunities you mentioned that are driving that? Thank you.
Thank you so much for the question, Emmanuel. So the Hyrimoz dynamics, there's not a really significant difference between whether it's direct own label or third-party label. So we don't see a significant difference in the two streams. Volumes, your guess is as good as mine, to be brutally honest. I think we're pleased with where we've landed. We've always said this is going to be a build rather than a bang. There are three PBMs. We expect to continue our journey with CVS and continue to expand the volume there. And we'll see how the other PBMs go forward, whether they choose to go on label or whatever over the next few quarters and into 2025. So I guess we'll see the weekly numbers and we'll take it from there. Colin?
Yeah, thank you. As this is a net sales call, I'm going to refer back to the earnings call in March. We were clear that the expansion in the margin during the course of 2024 would be driven by biosimilar volumes with the higher margin. And secondly, the operational improvement and transformation and organizational efficiency initiatives that we were committed to at the Capital Markets Day, as those start to be implemented and take an impact, that will deliver an expansion in the margin.
Our next question is from Vineet Agrawal at Citi. Please unmute your line and ask your question.
Yeah, hi. Thanks for taking my question. Just a couple. First, on the U.S. generics, can you possibly quantify the impact from the gross-to-net adjustment and the phasing of shipments? And do you see these two wash out through the remainder of the year? And then on your biosimilar Humira and particularly the Cordavis partnership, I think in the past you mentioned that the copay on the adalimumab supplied product will be higher. But we have seen a sharp increase in the scripts for that product too. I just wanted to check if the pricing on it has dropped such that the copay for patients is similar to, let's say, someone on your biosimilar, or is it more a reflection of the remainder 35% of CVS commercial formularies where you are not there yet?
Thank you so much, Vineet. I guess the second body question, broadly, yes. I think it's the 35% that remains. We don't see any significant pricing differences in terms of copay. Your comments on terms of U.S. generics, yes, you're right. So the U.S. small molecule generics business really had three impacts. Most of our launches are in the second half of this year. So that will certainly help with the washout. There was a gross-to-net impact. And then clearly, shipment timings in terms of Q1 coming into Q2. So over the year, I don't see any concerns in terms of the overall performance of the business. So I see it washing out as you described.
Our next question is from Thibault Boutherin at Morgan Stanley. Please unmute your line by pressing star 6.
Thank you. So the first question is on the future of the Cordavis contract. I think you mentioned it's a multi-year contract. Just wanted to know if there was a renegotiation time, so a period where terms could be renegotiated between you and your partners, and is there a time horizon where Cordavis could potentially add additional manufacturers to their co-branded biosimilar? Second question, just on the guidance. I mean, 6% growth in the first quarter against the complicated base, in particular for U.S. generics, biosimilar Humira contribution accelerating in the rest of the year. I just wanted to know what prevents you from upgrading your guidance on the top line at this stage of the year. If there's any kind of specific headwinds we need to keep in mind. And same thing for, I mean, similar question on generics outlook.
Tough comp in Q1, but from the second half of the year, you're going to have an easier base. So just if you could help us understand the dynamics of the generics business in terms of phasing this year? Thank you.
Yeah, thank you so much for the question. I mean, CVS, look, it's a multi-year contract. Clearly, we're pleased. I think both parties are pleased how the contract's moving forward and the patient's lives and the switching. So like any contract, there's always points that we would potentially look at renegotiating and/or changing it, but we're happy with the contract that we have, certainly for the short and mid-term going forward. So no real changes there. I think your question on guidance. Look, I think we're still first quarter end of the year. As always, as you say, there's puts and takes. I think at this point, it's important that we build credibility as a new company. So I'd rather be prudent and see how the next quarter evolves and look at that going forward.
Also, bear in mind, we saw very strong growth in Q1 last year, particularly on things like anti-infectives and a number of launches in Europe, which clearly the wash-through has come through into this quarter. We talked about apixaban. And then we see, as I think the previous question, the small molecule business broadly continuing as we see with the stabilization in the U.S. And then the biosimilar launches really backend-loaded towards the end of the year, particularly ustekinumab in Europe and natalizumab in the U.S. So I guess we'll look at guidance and look at the business in the middle of the year.
Thank you.
Our next question is from Harry Sephton at UBS. Please unmute your line by pressing star 6.
Great. Hi there. I hope you can hear me okay. So my first question was on the agreement with Cordavis. So we started to see more payers entering into these type of biosimilar exclusive agreements. So I was hoping that you can maybe help us understand why these type of exclusive agreements are more attractive to payers. It would seem that this type of agreement is economically more interesting to them or gives them more confidence on the security of the supply going forward compared to, I guess, the previous payer dynamics where you saw these big rebate walls impacting the launch of biosimilars. So yeah, I think the first question is really why have payers moved towards these type of agreements? And do you expect that this is very much going to be how you get biosimilar access in the pharmacy benefit channel going forward?
Then my second question is, in the results, you flagged a number of dynamics which contributed to the first quarter generic sales. So the weaker cough and cold season, the apixaban headwind, and then also the offset by the acquisition of Mycamine. So just wanted to get an understanding of what you saw as really the underlying dynamics within generics if you were to try and exclude some of those impacts and then also help us understand what some of those headwinds could look like for the rest of the year, especially with the apixaban withdrawal. That'd be great. Thank you.
Thank you, Harry. I guess, look, you're particularly seeing these agreements in the pharmacy benefit space, not in the hospital benefit space. So I think there the relationship between the PBM, the patient, and the physician is very much more aligned. So I think it's much more about the nature of the product. I think you're right. It's about ultimately security supply, the opportunity to strengthen that relationship and get a more secure business in relation to that. And I think we'll see whether other PBMs follow suit in terms of this as a strategy. So it's an interesting movement, and I think we're clearly pleased with how we're seeing it evolve. But we also have a nice strong franchise of our own right in terms of our own product. In terms of the Q1 dynamics, as you say, I mean, apixaban, that should wash out.
I guess it'll wash out in one of two ways. Ideally, the ideal way is we reverse the court decision in the Netherlands, which I always thought was a little bit bizarre. And we relaunch the product, which I guess is then a nice position. Outside that, assuming and we've assumed we're not launching it at the moment, that would wash out in the third quarter in terms of the negative impact to the growth. And then, as you say, there's always sort of puts and takes. I think what we're seeing is nice underlying performance in Europe in terms of winning share. Again, looking at the launches in the second half more than the first half, you've always got variability around the strength of the cough and cold season. So it's always prudent to take the softer view at this point.
But clearly, we have a stronger inventory position as we go into 2024/2025 cough and cold season. And then if we talked about the U.S., which really is sort of two or three one-time impacts and the gross-to-net impact that I mentioned earlier, most of the launches in terms of LOEs on the small molecules come in the second half of the year. That's just the nature of when the LOEs are. And then there were some shifting timings in the first quarter. So broadly, we've always said the small molecule business is always going to grow, I guess, low single digits when you look at it in an amalgamation of all the three regions. And clearly, a much stronger accelerating biosimilar business, A, the size of the launches, but also B, coming from a lower baseline. So putting it in percentage terms, it's always going to be much larger.
Okay, thank you.
Our next question is from Victoria Lambert at Berenberg. Please unmute your line and ask your question.
Hi. Thanks for taking my question. It looks as if the Cimerli share came under pressure in the U.S. over Q1. Is this because of the change in ownership of the U.S. rights, or are there some other factors driving the decline? And then just on the generics launches expected in H2, could we get a bit more color here, please? Are these weighted towards complex generics or simple? Do you expect to see a contribution from generic Victoza at this stage? Thanks. That would be useful.
Yeah, we don't break out the small molecule launches. We never have until the point that we launch for all sorts of reasons. So unfortunately, I can't give you the color in terms of the split between simple and complex. But certainly, most of the LOEs are more focused, particularly in the U.S., into the second half of the year. Your question on Cimerli, we'll have to come back to guidance. We don't see that view. I mean, certainly, we see the performance pretty much in line with what we saw forecasted. It's broadly stable with slight growth, which is pretty much what we'd anticipated when we acquired the business. So we'll have to come back to you.
Our next question is from James Gordon at J.P. Morgan. Please unmute your line and ask your question.
Hello, James Gordon, J.P. Morgan. Thanks for taking the two questions. First question was bios and North American performance. So this would be across generics and biosimilars. North American sales were sequentially down about CHF 91 million. And I think that's even with something like a CHF 20 million tailwind on biosimilar Lucentis. And I would have thought higher biosimilar Humira. So I heard a comment about gross-to-net timing and stocking there. But have things got significantly worse on pricing in North America? I could see at the group level, pricing looked about a percentage point worse. And are you still assuming that pricing is a mid-single-digit headwind for the full year, so some further deterioration from here, or what's the trend there? And is this worse pricing particular products for Sandoz, or is it just U.S. pricing has got worse in generics? That's the first question, please.
Second question was by division, so biosimilar performance. So on biosimilars, it looks like global sales were sequentially about flat, even with the tailwind from the Lucentis acquisition. So when you talked about some destocking, what's the trend on Humira there? So there was stocking up in Q4. Has that unwound, or was there a destock on Humira, or was Humira sales higher in Q1? How did that work? And more generally, is the gross-to-net you're talking about, is that a biosimilar gross-to-net, or is that on small molecule?
Okay, thank you, James. The gross-to-net is really purely small molecules. It wasn't a biologics gross-to-net drawdown. Actually, I think the impact was slightly larger than you described. So I think the U.S. small molecule business really, as I said, got impacted on three things: pricing, lack of launches in the first half versus the second half, the comps, and then clearly delays in terms of some of the shipments. We didn't see a stock in. I think we'd never guided that we stocked in in Q4. We saw a nice demand, and you see that being pulled through. So overall, the biobusiness grew very nicely, I think, at 21%. Now 25% of our total global business is now biosimilars, up from 22% last year. So I think the trend on the biosimilars is very solid or even beyond solid.
I'm pleased with the performance across all three geographies, but particularly the U.S. now where we're seeing, well, 20% growth in the biosimilar business. Yeah, sorry, globally to 20% growth. Sorry, my bad. So I think that covers the price. And then pricing trends, I mean, the optics of that looks a little worse because of the gross-to-net draw up. So the underlying pricing, we don't see a material change from last year. So I think we were planned for about 5% for the year. We're seeing probably lower than that by a couple of points, pretty much similar to last year. And no real major split between geographies, between Europe and the U.S. So we're not seeing a deteriorating position in terms of pricing. It's just the optics of that because of the way we booked the gross-to-net draw up tends to impact that a little bit.
Thank you.
Our next question is from James Vane-Tempest at Jefferies. Please unmute your line and ask your question.
Yes, hi. Thanks for taking my questions. Joe, if I can, please. I'm just following up on comments on U.S. drug pricing. I guess you mentioned you're not seeing a deceleration, but I was wondering if you can comment, at least in looking at some of the pharmacy pricing data, in February, you did see a gap down. And I'm just kind of wondering whether, at least from your perspective, that's more of a blip rather than the start of a trend. And is that one of the reasons why, at least coming back to one of the earlier questions, you're not looking to revisit the top-line guidance at this stage? And then the second question is just on the regional dynamics as well. I know at the time with the spin, you gave generics and biosimilars by segment, which you don't plan on doing going forward.
But for example, when we look at the 21% growth in biosimilars and zero in generics, can you just give us a flavor in terms of bookending the type of growth you've seen by region in each of those segments just to give us some color on performance? Thank you.
Okay, thank you, James. I mean, I guess we'll go back to my other question on U.S. drug pricing. We've not seen any significant trend change in terms of drug pricing. I mean, it's always two steps forward, one step back, two steps back, one step forward. And as we don't see any particular trend in terms of that, and clearly, things can change. And a lot of this ultimately is about consistent availability of supply and whether competitors come in and out of stock. But we certainly see any major changes there, and we sort of haven't, as I said, seen a trend. Yeah, we don't break out by region the biosimilar performance. But clearly, the U.S. is by far the fastest growing region in terms of biosimilars, partly because of the launches and the size and the baseline. And you can see that.
Then Europe, consistently, is a big business, but still is growing nicely, partly because of the launches of natalizumab, but also the continued share gains and the expansion of the market on products like Omnitrope and obviously adalimumab and others. And then international is the smallest in terms of biosimilars, but still grows nicely into a number of markets. So in terms of rate of growth, clearly, the U.S. is leading, then Europe, and then international. But we don't break it out beyond that. So hopefully, that gives you a little bit more color.
Thank you. Can you give us the same analysis for the generics business?
Yeah, I mean, I guess it's probably reversed. International tends to be the fastest growing region in terms of classic small molecule generics. Europe tends to be more, I guess, given its 40 markets, it tends to be a little bit more consistent, I guess, in sort of lower single digits. And then the U.S., ultimately, it's a single market with three payers, naturally has more volatility. That's the nature of the U.S. market. It is ultimately one country, one business with three wholesalers and three PBMs. So the timing of shipments has a big impact. And clearly, pricing and gross-to-net has a disproportionate impact given the size of the U.S. business. So that's how it would so I guess it's the exact opposite in terms of small molecules. So international, Europe, and then the U.S.
Thank you. So the European international were growing, and basically, U.S. wasn't, which brought about the flat?
Broadly, yes.
Okay. Thanks very much.
Our next question is from Folashade Ajayi at Redburn Atlantic. Please unmute your line and ask your question.
Thank you very much. My one question is about Hyrimoz. The U.S. volume share has risen from less than 1% to over 13% since the CVS deal. How do you see this figure evolving over the rest of the year? And should we see this deal and the share promotion as a template of future launches such as Pyzchiva?
Good question. I guess I can't really answer it because I don't know. I'm not trying to, I guess, clearly, look, we expect that to continue to grow. Clearly, other competitors potentially will take share. So as a percentage, I would expect our share to go down. But as a volume, I would expect it to go up. So we'll see how that evolves quarter-over-quarter. But I think we've always said, look, this was going to be a build rather than a bang. And at this point, I'm just pleased with the performance that we've seen, the credibility that the team have executed. And it's also worth remembering that one of the reasons that I think we've been successful is ultimately, we're a broad-based business. We have a strong relationship with the PBMs because of the small molecule business, because we know how to operate in that space.
We have a strong brand, a strong reputation. I think that's played to our capabilities. Then beyond that, yes, of course, you really got sort of two or three other products potentially that you could look at ustekinumab . And then clearly, also potentially, denosumab falls into that category as well because given the Deno, it's a two-product product. In a sense, one is for oncology indication, but the other indication is in the pharmacy benefit space again. So potentially an interesting opportunity. We'll see how those evolve over the coming quarters.
Thank you. Our next question is from Alastair Campbell at Royal Bank of Canada. Please unmute your line and ask your question.
Actually, I dropped my hand. Most of my questions have been answered. Thank you.
Okay, thank you.
Our next question is from Florent Cespedes at Bernstein. Please unmute your line and ask your question.
Good morning. Thank you very much for taking my questions. Quick ones on Tyruko and natalizumab. Could you give a little bit more color on the discussion with the FDA regarding the JCV test approval because it seems that the launch is a little bit delayed in the U.S.? And my second question still on natalizumab, if you could give us some flavor on the launch in Europe from the different countries would be great? Thank you.
Yeah, sure. Yeah, as I think I mentioned in my presentation, the FDA had a couple of questions on the JCV test. We're responding to those. And then we would anticipate an approval in the second half of this year. And on that approval, we would launch. Beyond that, I wouldn't comment further. And then in Europe, we're clearly very pleased with the launch. When you look at the shares, we've won the acceptance of the product, but we deliberately took an approach of rolling this out because this is a much more complicated product, clearly, with the assay, the JCV test, and the relationship and the confidence building with physicians. But as I said, we've rolled out into a number of markets in Q1. That will continue as we go into the second quarter. But the feedback from physicians and payers has been extremely positive.
So again, we're keen to build a long and sustainable franchise in this space.
Thank you.
This concludes the Q&A session. I'll now hand back to management for closing remarks.
Okay. Thank you so much. Just two seconds. So thank you so much. As I say, I've got the final page. Nothing else to add? So look, thank you so much for your time. Thank you for your questions. I look forward to talking to you all on August the 8th, where Remco will be joining me. And once again, I just wanted to thank Colin for his contribution, his support, and for getting Sandoz in such a strong place over the last couple of quarters and separating from the parents. So again, Colin, every success, every happiness in the next chapter of your journey. And talk to you all again in August. Thank you.
Thank you, everyone.