Good morning, ladies and gentlemen, and welcome to the Sandoz Call today. I will now pass on to Laurent de Weck, Global Head of Investor Relations, for his opening remarks.
Thank you, and welcome to the Sandoz Third Quarter and Nine Months Sales Call of 2024. Earlier today, we issued a media release summarizing our sales performance in the third quarter and first nine months of this year. In addition, we published a supplemental slide presentation on our website, which we will follow on today's call. You can find 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 Remco Steenbergen, our Chief Financial Officer. Our media release, presentation, and discussion include forward-looking statements. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs 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 presentation, we refer to 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. They should not be considered in isolation or as a substitute for the analysis of our operating result, as reported under IFRS. Non-IFRS measures are not measurements of our performance or liquidity under IFRS. They should not be considered as alternatives to Profit of the Year or to 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.
As a reminder, in the first nine months of 2023, third-party sales excluded sales to our former parent, as this was shown in a separate line item. Post-separation, sales to our former parent are reported as third-party sales. With that, I will now turn the call over to our CEO, Richard Saynor.
Thank you so much, Laurent. Good morning. It's a pleasure to welcome you to our third quarter and nine-month sales 2024 call. We had an exciting and promising year so far, and I'm looking forward to discussing our sales results with you today. The momentum in our business continues as we execute on our strategy. We are making considerable progress in our biosimilar launches, and at the same time, are achieving some of the key biosimilar products in our pipeline. I will talk more about our achievements in a moment. Our sales grew 9% in constant currencies in the first nine months of the year, driven predominantly by the very strong performance of our biosimilar business, up 32% in constant currencies to date.
In addition, growth in our generics business accelerated to reach 4% in the third quarter, or 2 percentage points over the first nine months of the year, driven by Europe. I am delighted to see growth across all our regions and would like to take this opportunity to thank all my colleagues at Sandoz for this great achievement. This robust top-line performance gives us the confidence to raise our full-year net sales guidance to high single-digit in constant currencies and to confirm our EBITDA margin guidance of around 20%, also for the full year. We keep on delivering on our top line, reporting our 12th straight quarter of growth. Top-line growth accelerated in the last quarter, reaching a record 12% in constant currencies. This growth was primarily driven by biosimilars, and once again, all regions contributed, a testament to the strong execution across our organization.
The ability to use our scale to deploy our portfolio and our ability to keep on launching successfully new medicines. In quarter three, price erosion was minus 1%, below the historical level. This is consistent with the decreasing price erosion we've observed in the last quarters, and we've assumed a similar low level for the rest of this year. Now, let's turn to the business. Our biosimilar business grew at a fantastic 32% in constant currencies in the first nine months of the year. We are pleased with this very strong growth as it reflects both the success of our new launches and strong demand for our base biosimilar business. Omnitrope is still experiencing strong customer demand in a constrained market supply environment. The uptake of Hyrimoz continued in the U.S., and the product retains the leading market share among biosimilars.
TYRUKO, or biosimilar natalizumab, is consistently taking share in Europe since its launch in late 2023, driving growth across the region. In July, we launched Pyzchiva, or biosimilar Ustekinumab, in Europe, and that's taking up nicely. In the same month, we also launched Jubbonti, or biosimilar denosumab, onto the Canadian market. We are progressing well on key biosimilar assets in our pipeline and are well positioned for the upcoming launches in 2025. Pyzchiva received FDA approval and will be launched in quarter one 2025 as per our settlement agreement. Enzeevu, our biosimilar Aflibercept, was also granted FDA approval, further enhancing our leading U.S. ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcomes of pending potential litigation or any other settlements. Let me provide a little bit more color on some of our products, starting with Omnitrope.
We launched the first biosimilar, Omnitrope, in 2006, 18 years ago, and we are still seeing strong double-digit growth. This ultimately speaks to the sustainability of biosimilars. Omnitrope is the market leader, with 36% market share, according to the latest IQVIA data at the end of June 2024. This market is still supply-constrained, and we're prioritizing this critical medicine to ensure patients are receiving the treatment they need. Now, let's turn to Hyrimoz. The progress in the U.S. has been strong. In addition to our private label agreement with Cordavis, through which Hyrimoz has the preferred access to 65% of CVS Caremark's commercial templated lives, we continue to win share with our own branded Hyrimoz and unbranded adalimumab add-ons. The most recent IQVIA data shows that biosimilars have captured 19% of the U.S. market.
If we then drill down on the adalimumab biosimilar prescriptions, we have 77% share, which includes our private label arrangement with Cordavis and, more importantly, the number one position with our own branded Hyrimoz and unbranded adalimumab add-ons. This puts us into a leading position in terms of market access and payer coverage amongst adalimumab biosimilars. We're on formulary with all three of the major PBMs, Pharmacy Benefit Managers. With regards to script data, please note that IQVIA stopped reporting Cordavis Hyrimoz and Cordavis Humira scripts. IQVIA is currently replacing the data with estimates but will stop reporting them completely as of January 1, 2025. Therefore, we can expect movements in the IQVIA data that will not reflect the reality of the market. We are currently exploring options to continue to provide reliable market share estimates through 2025. Now, I would like to update you on TYRUKO.
We started rolling out TYRUKO to markets across Europe at the end of 2023. Since then, we have been steadily growing market share, and we expect this to continue in the coming quarters. Both tender authorities and healthcare professionals appreciate a more affordable option in the multiple sclerosis space. To date, we've received positive feedback on the product, both from physicians and from payers. In the U.S., we are working with our partner and the FDA on the approval of our JCV assay and still expect to launch TYRUKO there in 2025. Moving to Pyzchiva, where we've made strong progress in the third quarter. In Europe, we were amongst the first companies to launch the product with all key reference strengths in July. At the end of the third quarter, the product was launched into 15 markets.
The uptake so far has been very strong, and we continue to roll out in additional markets. The physician's reception is positive, reinforced by the availability of an initiation dose, which is key to enabling patient switches. In the U.S., we received FDA approval in July. This extends our immunology portfolio and further strengthens our biosimilar position. We expect to be among the first wave of Ustekinumab biosimilars to launch in the U.S. quarter one 2025. With that, I will now hand over to Remco, who will discuss our financial performance and guidance.
Thank you very much, Richard. I'm also pleased to be here with you today to discuss our third quarter and nine-month sales. As Richard mentioned, we reported very strong performance in our biosimilar business and continued to experience solid demand in our generics business. Sales growth continued to accelerate in the third quarter with 12%, compared to 9% for the first nine months. Price erosion remained below historical levels, with -1% in the third quarter and -2% for the first nine months. Foreign exchange had a negative one percentage point impact both in the third quarter and the first nine months. This was mainly the consequence of depreciation against the U.S. dollar of several currencies in our international region, partly offset by the appreciation of the euro and the Swiss franc. Let's now move to sales by business.
Generic sales increased by 4% in the third quarter and 2% for the first nine months. The acceleration in the third quarter was driven by recent launches across various markets in Europe. The momentum continued in the international region, aided by favorable price dynamics and demand for the antifungal agent Mycamine, which we bought in 2023. This was partly offset by the divestment of the Chinese business. North America declined, as expected, due to timing of new launches in the U.S., which is skewed to the fourth quarter this year. The launch of Abraxane in October will help support growth in the U.S. generics business in the fourth quarter. Biosimilars delivered very strong growth of 37% in the third quarter and 32% for the first nine months. We are incredibly pleased with this performance and with the strong progress that we are making with our biosimilars overall.
The growth was driven by continued strong demand for our first-ever biosimilar Omnitrope, the ongoing launch of Hyrimoz in the United States, the acquisition of Cimerli, and contribution from the recent launch of TYRUKO and Pyzchiva in Europe. We expect this good momentum across both generics and biosimilars to continue in the last quarter of the year. Now, let's have a look at the performance of our three regions. All three regions delivered strong performance in the third quarter and the first nine months of 2024. Europe grew an outstanding 12% in the third quarter and 6% for the first nine months. Strong growth in biosimilars continues, led by demand for Omnitrope and the contribution from the recent launches of TYRUKO and Pyzchiva. Generics momentum accelerated in the third quarter, driven by recent launches.
Acceleration was also helped by the absence of strong prior year comparison of apixaban and the exceptional cough and cold season that affected growth in the first half. North America grew 18% in the quarter and 15% for the first nine months and benefited from the strong biosimilar performance, driven primarily by the ongoing uptake of Hyrimoz and acquisition of Cimerli, share gain of Omnitrope, and the launch of Jubbonti in Canada. The strong growth was partly offset by the decline of the U.S. generics business due to the timing of launches, which is skewed to the fourth quarter. Internationally, we grew 8% in the quarter and 9% for the first nine months due to the strong volume growth across biosimilars and generics, which contribution of Mycamine, favorable pricing, and recent launches. This was partly offset by the divestments of the Chinese business in the second quarter.
Our hard work and focus on delivering on our biosimilars pipeline continued to pay off. With another quarter of very strong double-digit biosimilars growth, biosimilars increased as a proportion of total net sales to 27% in the first nine months, compared to 22% in the prior year. Biosimilars even reached close to a 29% share of total net sales in the third quarter. Our regional sales mix remains consistent, with over half of our business in Europe, where we hold a strong leading position and the remaining more or less equally divided between the North America region and the international region. Now, let's have a look at our financing structure. In September, we issued a EUR 600 million bond maturing in 2029. The bond has an annual 3.25% fixed coupon. The proceeds are earmarked mainly for the refinancing of more expensive local debt.
Looking at our financial structure, our maturity profile continues to be well balanced, with an average maturity of non-current financial debt of approximately five years and a fixed floating rate of total financial debt of 76% and 24%, respectively. We target a floating debt rate in line with our average cash position. We have two solid investment ratings underpinning our company's strong financial position to support our future ambitions. We target a net debt-to-core EBITDA ratio below two times in the midterm. Now, moving to our full year 2024 guidance. I'm very pleased to inform you that we're increasing our top-line guidance for the full year. We now expect net sales to third parties to grow to high single digits in constant currencies compared to mid to high single digits, which we guided so far.
We're also confirming our 2024 guidance of Core EBITDA margin as a percentage of net sales, which is expected to be around 20%. As Core EBITDA margin expansion in the second half of 2024 has been a focus of recent discussion, I would like to reiterate the key drivers that make us confident that we will reach our full year 2024 guidance of around 20%. Firstly, strong biosimilars growth drives continuous improvement of our business mix and therefore our margin. Secondly, we expect both price erosion and input cost inflation to be limited in the second half of 2024. Thirdly, we expect further manufacturing efficiencies in the second half of the year. Fourthly, as we grow sales, we will further leverage our cost base. This is best highlighted by our recent launch of Pyzchiva in Europe.
Here, we are already a leader in immunology and can leverage our existing sales force without adding incremental expense. Lastly, our transformation program, which started in the first half of the year, is expected to generate around $50 million of savings in the second half of 2024. Thank you for your attention, and with this, I hand it back to Richard. Richard, I'm sorry to intervene, but we cannot hear you.
My microphone is working. I can hear you fine.
Okay, we can hear you again.
Okay, I apologize. I'll go back to Outlook. I do apologize. So again, if I'm repeating myself, I apologize. We're excited by our next key biosimilar launches planned in 2025, as mentioned earlier. We will launch Pyzchiva in the U.S. during the first quarter, and we will launch Jubbonti in the U.S. in the second quarter, as per our agreement with Amgen. We expect to launch TYRUKO in the US during 2025 and pending FDA approval of our JCV assay. Our next financial update will be published in our integrated annual report and host our fourth quarter and full year results in 2024 on March 5, 2025. Earlier this month, we celebrated our first year of independence through a spin from our former parent, but we became the world's leading pure-play generics and biosimilar company.
I'm very proud of the significant milestones we've achieved in the past 12 months, including successful biosimilar launches, key advances in our pipeline, and initiatives to supply our business. This is fully in line with our commitments we made ahead of our spinoff, which has put us in the best position to deliver our midterm guidance. All of this with the objective to deliver superior value and creation for society, our shareholders, by pioneering access for patients. With this, thank you very much, and I 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've dialed in, please press star nine 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 at the Zoom app, or via telephone, press star nine. Thank you. Our first question comes from Harry Sefton at UBS. Please unmute your line.
Brilliant. Thank you for taking my questions. So my first question is on the Aflibercept U.S. launch and whether there's any implications for you potentially launching your product after Amgen launched at risk. And if not, can you maybe walk us through what the milestones are on the litigation front to get line of sight on the U.S. launch and then also your appetite for a potential At risk launch? And then my second question is on the margin. And just to play devil's advocate, you've raised your sales guidance from mid single digit to high single digit through the year, mainly driven by the stronger biosimilar performance. Now, we would expect biosimilars to be higher margin, and we'd also expect you to get some operating leverage on the stronger performance.
So my question is, why have you not seen as much benefit on the margin front from the strong performance at the sales line? Thank you.
Thank you very much, Harry. I'll perhaps take the first part of the question, and then Remco, I'll let you take the second. Aflibercept, I think, as I said in my presentation, clearly will now, A, the Amgen launch doesn't change our thinking in terms of product. Each product has its own formulation. Our formulation is different to Amgen's. We will consider our own position in terms of litigation, launching at risk, our potential settlement independent of that. And so really beyond that, I can't say a great deal more. Remco, do you want to pick up on margin?
Yeah, Harry, good morning. Remco here. Yes, we have indeed increased our top line from mid single digit to high single digit, and we left the 20% unchanged. The main reason for this is that the transformation savings, which we had planned for this year, actually started a bit later in this year. I already referred to that as well when we had our half-year results in August. So underlying in the margin improvement we're seeing and also the functional cost development itself, we are on target, but the transformation savings simply came a bit later in, and that's why we're still holding with the 20%. Of course, the good news of that is that from the transformation savings, we will get a little bit more next year.
Brilliant. Thank you.
Thank you very much. Our next question comes from Thibault Boutherin at Morgan Stanley. Please unmute your line.
Thank you. First question is on the sustainability of U.S. biosimilar Humira revenues, in particular next year. Looking at IQVIA data, and I understand these aren't necessarily fully reflecting the reality, but the scripts seem to be broadly stable. Vast majority still generated through core device. So how could you help us think about the sustainability next year? Is pricing a topic, or is it secured? And same thing on volume commitment from core device. So that's the first question. And the second one is just on your strategy for biosimilars in immuno-oncology. You are developing biosimilars for Keytruda and Opdivo. There are other products like Tecentriq, Imfinzi, which are also multi-blockbusters and could present a meaningful opportunity with likely less biosimilar competition than Keytruda.
So if you could just talk a little bit about the strategy here, and is it because you're thinking that in the long term, immuno-oncology volumes are going to be mostly Keytruda or Opdivo, or is there something else in your choice of biosimilar? Thank you.
Good morning. Thank you for your questions. I guess let's talk about clearly on the U.S. performance of adalimumab. I'm delighted with what the team have achieved. I think clearly there's two parts. There's the own label with Cordavis, which broadly, I think in volume terms, I would expect to be flattish as we go into next year. I think we already saw the incremental volume change that we saw. And pricing, really, again, that's really between ourselves and our partner, but we're comfortable with the position that we have going into next year. I think the opportunity, though, still that nearly over 80% of the market is still with the originator. And that part I see as more of a stepped progression of volume increase.
And again, there, I think we are the leading player in our own brand product, which gives me a lot of confidence, plus also bearing the fact in mind that we're also on formulary with all three of the PBMs, with a good presentation, a strong sales force, an introductory pack. So I'm confident that we would look to seek incremental volume increase on the core business as we go into next year. The pipeline question is a good one. I mean, we're generally therapy agnostic, so we don't normally look at a pipeline and think about we want to index in immunology or oncology. Now, most biologics tend to be in those spaces anyway. We don't disclose the pipeline until we get to phase three assets. Clearly, I don't want to make my life any harder with our originators or our competition or our other players in the marketplace.
But clearly, we look at a mixture of where there are larger opportunities, where we think we can leverage our scale and our technical capabilities, mixed with where we see market expansion opportunities. The other point worth taking is generally we try and focus on where we see strength in Europe, and then we can see the U.S. as becoming an incremental opportunity. I think many times the trouble with the U.S. market is if you focus purely on the U.S., the timing launch is very variable. You've got to go through a patent dance. So we try and make sure that we file launch and can leverage Europe, and then the U.S. can become an incremental opportunity. So I hope that gives you a little bit more color around our thinking.
Our next question comes from James Gordon at J.P. Morgan. Please unmute your line.
Hello, James. Hope you can hear me okay. This is James Gordon from J.P. Morgan. Thanks for taking the questions. Two, please. First question was on North American generics. So I can see very nice performance for biosimilars in Europe today, but if I had to find a weak point, it looks like it would be the North American generics performance. And if we try and back it out, it looks like that business year on year is down mid or maybe even high single digit. Is that right? And is what you're saying that's going to go from mid or even high single digit year on year decline to growing in Q4? And is that acceleration just from Abraxane or are there other meaningful launches in Q4 and into 2025? How are you thinking about that business?
Is it declining that much and it's going to flip to such strong growth? And why would that be? And the second question is on reinvestment. So it sounds like you're well on track for the EBITDA margin to step up a lot in H2 this year. But then when we look to next year, do we extrapolate off H2, which is where you are now, or only off the full year 2024 margin? And are you thinking about a lot more R&D investment for pipeline, maybe for generics pipeline next year? So could R&D be like double digit growth next year? How are you thinking about that, please?
Thank you. Good morning, James. I'll press again to take the first question. Remco, if you take the second. Look, I think your question is a good one on North American generics. Clearly, our strategy in the U.S., if you take a step back, our ambition is to become the leading biologics player in the U.S., and clearly we're well on track to deliver that. The generics business, I don't have the same aspiration. It's really much more, I guess, a tactical business. We want to think about where we can launch products and broadly keep that business stable. You're right. First part of this year, we saw declines. Clearly, we've seen, obviously, we launched back with Taxol. We see a number of other smaller launches. I think this year we'll see the generics business probably still with a slight decline overall.
But then when you again step back, what's really encouraging is the overall growth of the U.S. business in this far more attractive biologics space, so growing 15%. So I think that's really the key message is see the U.S. as a whole, strong growth in the U.S. The generics business has always been for me a more of a tactical business, and really then making sure we launch products that support the margin expansion rather than trying to go for a mass coverage. And this year will close probably just slightly negative. But you're right, clearly a number of launches that we expect to see, but most of them fairly small in the final quarter.
Hey, James. Remco here, with regard to your second question. In terms of the extrapolation into 2025, we will give some guidance, of course, in March next year. It's a bit too early right now. But if you already work on it, you have to take the full year margin as the starting point. The phasing over the year is a very difficult one to take because there are different pluses and minuses in there. So that will take into account. Of course, with the opportunities and the way we're currently performing in biosimilars and what I think every one of you know over the coming 10 or 15 years, there's so many biosimilar opportunities over the years to come. And of course, we want to capture them. And with that, yeah, of course, we intend next year to bring our investments in our pipeline up.
And with that, you would also see that our R&D expenses next year would go up. Whether it will be really double digit or below double digit is too early to say, but of course, we want to invest and we want to do the right thing here. With that said, just to reemphasize, correct, on all the other costs, correct, and delivering on also restructuring a program that is still out there and that also you have to take as a baseline for next year. I hope that answers your question, James.
Thank you. Our next question comes from Simon Baker at Redburn Atlantic. Please unmute your line. Thank you.
Thank you. Take my question. Sorry, I took a little while to unmute there. Two, if I may, please. Firstly, Richard, returning to adalimumab. As you said, the real opportunity is the 80% that AbbVie still controls. I just wonder if at this stage, if you can share anything in terms of visibility of how that may change in 2025. AbbVie have said that they will see continued roll-off of contracts, so they're clearly expecting it to go down. I just wonder what you're seeing at this stage. And then secondly, on Hyrimoz, it has been a great performer, helped by supply constraints. I just wondered if there's any update on the evolution of the supply constraint there. Do you expect to see 2025? I mean, in that scenario, how sticky in that market? Thanks so much.
Okay, thank you so much, Simon. I think you're right. Look, 80% of the market is still available. And I think I said to you before, the fact that we're on formulary with all three of the PBMs puts us in a really strong position. You're right. I expect a number of those contracts to rotate during next year. And then I'm confident, given our scale and our performance of our own label product or our own brand product, Hyrimoz, the Cordavis deal, in terms of that strength. And again, I think I've said before, if you take a step back, we're the global leader in this space. We have a great presentation. We have all the strengths. We have a patient support group. We have the introductory or a starter pack that is unique in the U.S. market. So I think we're extremely well positioned.
Physicians and patients like our product. And so long as we're on formulary, we're in a strong position to then capture a share. I think I would expect that to be more incremental growth, though, next year. I don't see another big step up in the same way that we saw earlier on with the Cordavis deal. On Omnitrope, I think it's two points. Yes, I still think the supply constraints are going to continue. And I think those are really more linked to other products that a number of competitors are prioritizing over the supply of human growth hormones. So I think that capacity constraint, particularly in GLP-1s, is going to drive the sort of secondary impact in terms of Omnitrope. So I don't see that changing during 2025. And then how sticky? Generally, this is a presentation that kids receive really at home.
Parents generally don't want to switch formulations. Physicians don't want to switch formulations. So generally, we find that patients like the product, stay with the product for the dual treatment course until they reach adulthood. So I think it's a pretty sticky product. And clearly, we've seen it perform well over the last 18 years, which is quite remarkable. And I don't see any trend change going into next year.
Thanks so much.
Our next question comes from Eric Le Berrigaud at Stifel. Please unmute your line.
Yes, good morning. Two questions. First, on TYRUKO in Europe, could you maybe contrast a little bit of performance so far with history? You showed on the graph kind of 16% market share gain after six, eight months. How does that compare with traditional biosimilar launches in Europe? Can you maybe also point which countries the drug has been launched at this point? And maybe if one was relatively early, like Germany, in most of the cases, how much market share did you gain into the first market launches? And which one are still to come? And then the second question is about Abraxane, impacting Taxol opportunity in the U.S. Just to give me a sense of how much competition you will face, is it a several players game or are you among a few there just to see what kind of competition you may have? Thank you.
Thank you so much, Eric. I'll pick up paclitaxel first. I mean, at the moment, relatively small number of competitors. Now, clearly, this is the U.S. generic space, and that situation can change, but clearly, we're pleased with the performance that we've seen to date. I'm glad to bring this product to market and make this available to patients. TYRUKO update, we've been very pleased. It really depends on the markets. Clearly, some of the tender markets, we've actually taken leadership share because of the positioning of the product. Other markets tend to be more physician-led, and that tends to be a little bit more incremental, and I think that's probably consistent with biosimilars generally. I mean, certainly in Europe, there's no real resistance to the use of biosimilars. I mean, this physician group, this is relatively rare for them to see a biosimilar.
So, I guess connecting with them, but certainly with the product and the take-up has been strong. From memory, now we've launched in eight markets across Europe. I could be slightly wrong, particularly the larger markets. I'm not going to break down individual market share performances as we tend not to do that, but certainly pleased in terms of how it's performed relative to our expectations and relative to previous biosimilar launches.
Thank you very much. And next question comes from Victor Floc'h at BNP. Please unmute your line.
Hi, good morning, and thanks a lot for taking my question. Victor Floc'h from BNP Paribas. And first of all, congrats for a very strong print. So my question is on Pyzchiva and the importance of securing a preferred status for the US PBM, just like what you've done with Hyrimoz over the last year, over this year. And so I was wondering if it's fair to say that the recent launch in Europe could actually help your discussion on the other side of the Atlantic. Any update on those discussions will also be very much appreciated. Thanks a lot.
Thanks so much. Thank you, Victor. I certainly don't think it'll do any harm. Let's put it that way. I'm clearly delighted how it's performed. I think clearly having all presentations and indications and the starter presentation has also shown to be very beneficial. I think going into the U.S. with that confidence. Clearly, I think there's going to be two parts. I'm confident given our performance of our adalimumab away from Cordavis that we're capable of building a strong franchise in our own right. Clearly, that's my expectation as we set up our business. I can't discuss the details, but clearly, we would consider looking at potential partnerships with PBMs if appropriate in the U.S. market as well.
So really sort of looking forward to the launch, clearly taking the learnings from Europe, leveraging our strength, and we'll see what happens then on the PBMs.
Thank you very much, and next question comes from Emily Field at Barclays. Please unmute your line.
Hi, thanks for taking my questions. Firstly, just on the down 1% pricing erosion, I know you guys don't guide for erosion by geography, but I was just wondering if you could provide any descriptive color on where you're seeing the pricing environment as more supportive between the U.S. and Europe? A question on Hyrimoz, that was helpful commentary about thinking of the gains being incremental going into 2025, but more of just like a big picture question. I guess, what is it going to take for the biosimilar share in aggregate to become meaningfully above this sort of 19%-20% that we've been at for a while?
Then just a quick clarification question, just as I wasn't familiar with this change that IQVIA is going to be putting through in the data, is that coming from you guys for 25, or is that a change moving to this estimate that is driven by IQVIA, just so we can understand just how the data presentation is going to change? Thank you.
Pick up the IQVIA. That's IQVIA. This is CVS's decision not to provide the data to IQVIA. It's got nothing to do with us. I think it will just mean that the visibility and the trends aren't going to be as accurate. We're going to try and find other alternatives if we can. I know you're used to a very good level of granular data coming from independent sources in the U.S. I think it's really just sort of putting a note of caution. Don't necessarily look at it and take it at face value. I think there's going to be some questions as IQVIA use algorithms rather than real data to present that. That's very much an issue between IQVIA and CVS. Then go back into pricing.
Yeah, I mean, look, it's always very. I always get these questions on pricing, and I understand why. Yes, we're clearly pleased, and I think we see a general trend since coming out of COVID and then the inflation spike, and certainly the discussions I'm having with payers and government around the importance of generics and biosimilars and their ultimate sustainability. So I think that there's a trend that's encouraging. Now, whether that trend continues, clearly, I would hope so, and I'll do everything I can to support it. And then it's really down to individual products. At the end of the day, generics in the U.S., small molecules, this is down very much to your level of competition and the appetite then for changing supply with the GPOs and the wholesalers.
So I think the U.S. is always naturally a little bit more volatile given how the market is constructed. International, more because we've seen strong inflation, we've actually been able to take price. There, your ability to increase your pricing is much stronger. And then in Europe, it's sort of puts and takes, really. I don't think we've only seen any significant downward trends. It really depends on individual products. And in a few cases, we've been able to leverage and take modest price increases. So it tends to be very variable. It's very market and very product specific. But hopefully, I've sort of given you a sense of the direction. So thank you, Emily.
Thank you very much. Our next question comes from Naresh Chouhan from Intron Health. Please unmute your line.
Thanks for taking my questions. Can I just push a bit on Hyrimoz's biosimilar kind of dynamics for next year? Obviously, the contract and negotiations are largely done in Walgreens. I appreciate you may not comment on Hyrimoz's directly, just more broadly. Now you've seen what the kind of backdrop looks like. How should we think about biosimilar share of Adalimumab next year? And you mentioned step changes. Is it something you've seen that we should be thinking about in terms of step change for next year at a kind of total US level? And then just on the 1% price decline, can you just confirm whether you're referring to when you refer to pricing, is this just price or is it a combination of price and mix?
And then lastly, on R&D spend, and as we think about R&D growth, can you help us understand the mix of R&D spend between generics and biosimilars and the extent to which over the next few years, biosimilars kind of dominate your R&D investments and how we may be able to absorb some of that growth in biosimilars as you shift away from generic investments to more biosimilar investments? Thank you.
Thank you. First, Emily, I don't think I partly answered your question on Hyrimoz, but in a sense, Naresh's question allows me to broadly expand it. So look, I think what I said, I really think this is going to be much more like an originator-based type behavior. What I mean is now converting patient by patient as formulary switch. So I don't see another big step change, but I just see incremental increases as patient lines switch and insurers change their formularies. So I think the important thing is, A, with the strongest brand, ex the CVS deal. B, we have a very strong presentation, a great deal of real-world evidence, a capability to build that brand as you've seen with our own products year to date.
And then C, the fact that we're still on contract or certainly on formulary with all of the PBMs puts us in a very strong position. So I just expect to see that incrementally increase during the year. It's still a huge opportunity. I mean, as I said, 80%, and we'll see that going forward. Price, yeah, ultimately, it's a little bit of price. It's clearly there's some mixed effect and also actually a little bit of currency effect in there as well. So it tends to be a mixture of those things, but still predominantly our ability to take price or not. R&D is a great question. We don't break out the split between biosimilars and small molecules. Again, if we look at the broader picture, there's $400 billion of product coming off patent in the next 10 years.
In fact, there's more product coming off patent in the next 10 years than has come off in the history of this industry. So no shortage of opportunities. Small molecules are still highly attractive. We still aim to cover about 80% of LOE in Europe. And actually, 60% of all the products coming off patent, I would class as small molecules. So it's still an attractive share. Clearly, the bulk of our or a larger proportion of our R&D spend tends to go around biosimilars because they're more expensive. But also, there are a lot of synergies between the two. So clearly, a lot of the clinical, a lot of the regulatory and medical organizations are shared resource between both the biologics development and the small molecule development. So it's quite hard just to say simplistically breaking it out.
But certainly, I would say more than half of the spend tends to go towards biologics and a smaller proportion to small molecules. I don't see that change materially shifting. I would like to overall increase the quantum as Remco discussed earlier, but not necessarily stopping spending on small molecules because I still think it's an attractive space and generates the cash momentum that you need for the longer-term investments that you need to make in biosimilars. Okay, thank you so much, Naresh.
Richard, if I just can add on what you just said, for just to avoid any misunderstanding. What we try to do in the calculation of the price erosion is to exclude as much as we can the FX and the mix. Of course, you can do that perfectly, and that was where Richard was referring to, that there is a little bit of mix. But just that you don't have the understanding that the price erosion is included in the mix. It's not. Price erosion is separate. FX is separate. But in the calculation, there's always a bit of risk that something stays behind. Just for clarification.
Thank you, Remco.
Our next question comes from James Vane-Tempest at Jefferies. Please unmute your line.
Hi, can you hear me?
Yes, I can.
Thank you. Two questions if I may. Firstly, revenue growth has sequentially got stronger through the year. So if you've grown 9% at nine months and 12% in Q3, driven by new launches, as you mentioned, with the momentum you're seeing, what's holding you back from not including low double digit in your top line outlook? Because it does seem as if you should be able to deliver more than 10% growth for the full year. So is that conservatism or something in the Q4 base we need to be mindful of? And the second question is, I appreciate this is a revenue call, but can you give any flavor on profitability in Q3, just given you need to do more than 22% margins in the second half to meet your guidance?
So I guess, for example, can you comment directionally on the relative profitability in Q3 to Q4 to reach this target or the $50 million of savings? Is that more likely to be Q4 versus Q3 weighted? Any comments like that would be helpful. Thank you.
Remco, do you want to take those?
Of course. For the revenue, yeah, of course, we are very happy with 9% and in the first half and 12% in Q3. As it currently stands, we see a high single-digit number based on the outlook we currently see for Q4. So that's what's guided. Of course, it would be lovely to end up in double digits, but as we currently see, that's not in the cards. With regard to the profitability, clearly, this is a sales update. So also, I cannot comment on the Q3 profitability. But let me help you overall, correct? And also in the slide presentation, we have guided to go from 17.5%-20% overall, which means close to 22% in the second half, which has a couple of categories to realize that.
One is to further mix improvement, and you have seen, of course, in the sales in Q3 that our mix is moving into the right direction. The other elements which are there are on the whole transformation, the 50 million, which we also said in the August update and in the speech you have heard as well, that we're confirming that we're on track with that 50 million, and the last part is, of course, the whole functional cost development and the further sales growth and the leverage on the total sales number, and there also, there's given some information, at least on the sales line, how we developed over Q3 and how we have to see in Q4. I cannot comment on the cost development. Of course, you can assume that we do our best to deliver on that number.
We have said as well in August that we would expect in the second half a low single-digit price erosion. Now, in the top line, you have seen the minus 1% is a low single digit so that you can also use and the input cost inflation, correct? We have also indicated that we'd see this to be very low in the second half. I cannot comment on Q3, but you have also the general information on the topic. I hope without saying anything on Q3, I gave you enough data points to what is really known to see where we roughly stand, James.
Thank you.
Thank you very much. Our next question comes from Victoria Lambert at Berenberg. Please unmute your line and ask your question.
Thanks for taking my questions. I've got three, please. The first one is just on the stronger Swiss franc, what impact is this expected to have on full-year margin? I think it had 100-200 basis points impact last year. And then the next one is just a clarification question on your Humira market share. It looks like this is down 80 basis points from July. Is this just because of the change in how IQVIA is reporting because of the data it's being given from Cordavis? And then lastly, just on your biosimilar Stelara launch plans, so you haven't announced a pharmacy benefit agreement yet. How much lead time do you need to give once an agreement is reached? Is this like three or four months? And do you think this will be necessary to get a similar share development as you have in Humira? Thank you.
Thank you so much, Victoria. Remco, do you want to take the first question, then I'll pick up the other two?
Okay. Yes, you have seen also in prior year and the first half of this year, correct? There is a negative FX in our margin coming in, correct? We have to keep in mind that's not only the Swiss franc, correct? There's also our international region where we sell in all different emerging market currencies. And also there, where Richard said, of course, then you have a negative impact on the FX. But on the prices, we can actually increase prices to offset that. That's how the market works. So you have to keep that into account when you see a slightly negative FX in the margin. Yes, a strong Swiss franc, of course, on balance has some negative impact because our costs are more in Swiss franc than our top line is. But with the other euro and US dollars, you have to keep that in mind.
And also have to keep in mind that we report in U.S. dollars, correct? That's our functional currency, so it's not Swiss franc. So all in all, in the first half of this year, you have still seen a slight decline in the margin because of the FX. And we expect that to continue in the second half as well, right? So in that sense, normal course of business, nothing special here. Back to you, Richard.
Thank you so much. So I think the IQVIA data is a fair question, but we've always said we had an 80% share or market share of the available market. That percentage was always going to start coming down as other own-label products start coming into the marketplace. But certainly, in terms of absolute performance, we're happy with where we're going. And I think clearly there's always going to be some volatility in the data. So that's just the nature of the U.S. IQVIA data. The Sandoz ustekinumab question, I think it's a fair question. Again, we have plenty of time to manage whatever relationship we would want to put in place if that so works out. So again, we're comfortable where we are and clearly focusing on our launch plans as we talked about earlier. We're excited about this launch.
We have a strong immunology presence clearly in the U.S. We have a capable salesforce as demonstrated by our own label performance away from CVS. And clearly, we have the capabilities then to work with PBMs moving forward. And clearly, we don't see time under particular pressure here. So we'll see how that one evolves.
Thank you very much. Our next question comes from Graham Parry at Bank of America. Please unmute your line.
Great. Thanks for taking my questions, actually. We've got a couple of follow-ups to Victoria's questions there. So just on the Humira point, though, you were saying penetration to the overall market, but lower share. So can you confirm whether Humira biosimilars actually fell quarter on quarter versus Q2? Or did overall market growth still see revenues for that biosimilar in the US go up? And then secondly, just on the potential for a PBM contracting or a stick-in-the-mud, when would you expect to update the market on that? So I know you say you've got plenty of time, but is that something we shouldn't expect to hear anything confirmed on until for your results next year? Or could we get an update before the end of this year, for example? And then thirdly, just your thoughts on Aflibercept launch timing in next year.
I know you said this is TBD pending litigation, but just any thoughts on whether the Amgen court ruling and their intent to launch at risk changes anything for you in terms of your legal position or intent to launch? Thank you.
Okay, I'll press on those backwards. Thank you, Graham. Aflibercept, no. As I said, different formulations, different. So each product really needs to see in its own right. We've not been in our guidance for 2025, and we wouldn't change our position. Clearly, we need to go through our own patent dance, potential litigation, and/or settlement. And so we just need to see that separately. Ustekinumab, again, whether this is disclosed or not, it's partly also down to our partner whether they wish to disclose it or not. So difficult question to answer, truth be told. Clearly, if that position changes and our partner is aligned that they want us to disclose, then we would. If not, then we would update after the event going forward. So I guess that's why I made the comment to Victoria. We'll wait and see.
And then on adalimumab, we don't see really a significant noise in the data. Also, you're seeing the originator driving. So you actually look at the overall volume market has declined a little bit because what you're seeing is the originator effectively rebating switches from the adalimumab to different drugs in the market. So that's having some small impact. I expect that trend not to stop during 2025 as we see more biosimilar penetration. And then I would expect in the medium-long term, actually, the market to grow as patients are offered this product earlier in the disease cycle. But in terms of our overall performance, we don't see a significant change in terms of our expectations. Thank you so much.
Thank you.
Thank you very much. Our last question comes from Jörg Zimmermann from Octavian. Please unmute your line.
Thank you. This is Jörg Zimmermann from Octavian. So first, congratulations on the good results. And then thank you for taking my question, which is related to the partnership of Blue Shield of California together with Fresenius. In that partnership, my understanding is Blue Shield is able to directly purchase their Humira biosimilar from the manufacturer, thereby circumventing the PBM. So here, the question is, do you think that has any impact on the Hyrimoz business? And in more general, is that a deal structure that you expect to see more often in the future? Could it be something for Pyzchiva? And then lastly, just more general, probably as the PBMs are quite in the media in the US as well, any views on the role of PBMs moving forward? Thank you.
How much time do we have? Great question. Thank you so much. On the Blue Shield, no. I mean, look, it's an interesting development, but you see all of these things in the news. Honestly, I really don't. I reviewed this with the U.S. team. I don't see any impact on our business at all. I think with our competitors struggling to find share, you're going to find all sorts of creative ways to see the opportunities has any material impact to our business or the model. I guess, again, similar. We'll see how that evolves. We discussed that quite a lot this morning in terms of how that's going to evolve. I mean, first and foremost, both Pyzchiva and adalimumab are relatively unique. Most biologics launch into the medical benefits space, not the PBM space.
These two products are pharmacy benefits, so they lend themselves much more to significant opportunity and PBM role, because they're clearly a significant customer, but every other market in the world, particularly if you look at it with a European lens, PBMs don't exist, so they are a distorting effect on the U.S. market, and I know having been to Washington and met with the FTC and a number of other congressmen, etc., etc., there's a lot of talk about the power of the PBMs and how corrupt. I think clearly there's a move to rein in the rebating, how that I think it has a distorting effect on the market, and clearly, you've seen that with a relatively slow uptake, and clearly, the regulators see that. It's not something that they like to evolve a little bit by prioritizing their own. Regulators, payers, government is very pro-generics and biosimilars.
They see that we're part of the solution, not part of the problem. So I'm optimistic over the medium and long term that things will evolve to support our business and create more opportunities for patients, which I think is a nice way to close today. So thank you for your questions. Clearly delighted to update you on the strong performance from Sandoz when we have our full-year 2024 earnings and sales call.