Sandoz Group AG
SIX:SDZ
Earnings Call Analysis
Q4-2023 Analysis
Sandoz Group AG
Sandoz had an exceptional year in 2023, completing its spin as an independent company and outperforming expectations with sales exceeding guidance and core EBITDA meeting targets. The company marked its ninth consecutive quarter of top-line growth in Q4 2023, a period in which the North American region notably surged 20%. Overall, full-year sales grew 7% to reach $9.6 billion, driven by a 10 percentage point contribution from volume, slightly tempered by a 3% influence from price erosion, less than in prior years. Core EBITDA hit $1.7 billion with an 18.1% margin, reflecting higher sales and favorable product mix, countered by predicted expenses and foreign exchange headwinds.
Despite witnessing a negative free cash flow of $234 million in 2023, Sandoz is projected to significantly bolster its cash generation, aiming to deliver 2.5 times its 2022 free cash flow by 2028. The generics business expanded by 5% on a constant currency basis, aided by strong demand and diminished price erosion, while the biosimilar business increased by 15% on a constant currency basis due to strong demand for existing products and new launches like Hyrimoz.
Sales in the fourth quarter soared to $2.5 billion, a 10% year-on-year increase. The generics segment realized a solid 6% boost from both existing and new product launches, with significantly lower price erosion than the year before. Conversely, biosimilars showed remarkable growth at 26%, largely attributed to ongoing demand for Omnitrope and the U.S. launch of Hyrimoz.
Across various regions, Europe, North America, and International markets all displayed growth in the fourth quarter and the entire year. Notably, North America, building on stabilization efforts earlier in the year, recorded an impressive 20% growth by year-end, while International regions achieved a 14% growth, driven by volume increases in Australia and Brazil coupled with biosimilar sales.
Core EBITDA margins were challenged, decreasing by 3.2 percentage points to 18.1%. This was due to a combination of legal costs of $576 million, separation costs of $155 million, and rationalization costs as part of the broader ambition to streamline manufacturing sites.
At the close of 2023, Sandoz secured a robust balance sheet, having raised $3.2 billion from dual currency bond issuances and ending the year with $1.1 billion in cash and equivalents. The net debt to core EBITDA ratio stood at 1.8x, with expectations for it to remain steady between 1.7x to 2x despite anticipated investments in various strategic areas.
Sandoz provided guidance for 2024 expecting mid-single-digit net sales growth in constant currencies and forecasting core EBITDA as a percentage of net sales to be around 20%. Over a longer horizon, the company envisions an increase in core EBITDA margin from 18.1% in 2023 to between 24% and 26% by 2028. Furthermore, the dividend payout ratio is projected to grow to 30% to 40% of core net income by 2028.
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Good morning, ladies and gentlemen, and welcome to the Sandoz call today. I will now pass on to Karen King, Global Head of Investor Relations, for her opening remarks.
Welcome to Sandoz 2023 Results Conference Call, where we will discuss fourth quarter and full year sales and full year financial performance. Earlier today, we issued a press release with accompanying financial tables and posted our first annual report, which includes a more comprehensive financial section, our governance and compensation report and an integrated ESG report. We also have published a supplemental slide presentation on our website, which 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. 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 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 document, we present certain non-IFRS measures. These non-IFRS measures may be comparably to or 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 alternatives to profit for the year or any other performance measures delivered in accordance with IFRS. For discussion purposes only and in today's presentation, sales in this document refer systematically to net sales to third parties, excluding sales to our former parent. And our comments on growth are expressed in constant currency. And with that, I'll now turn the call over to our CEO, Richard Saynor.
Thank you, Karen, and it's a pleasure to welcome you all to our first fourth quarter and full year 2023 Sales Results and Full Financial Results. 2023 was an extraordinary year for Sandoz. Not only did we complete a successful spin from our former parent, but we delivered on many of our strategic milestones, thanks to the passion and tireless efforts of our employees. Our strong performance is reflective of our progress with sales growth exceeding our guidance and core EBITDA meeting our guidance. We achieved many milestones, including developing critical partnerships and launching new products in our biosimilar business, enhancing our generic portfolio through bolt-on acquisitions, divesting nonstrategic assets, securing long-term financing and ensuring business continuity as we became an independent public company. As of 2024, we have strong momentum, and we look forward to creating sustainable, long-term value for our shareholders and society. Fourth quarter 2023 was our ninth and strongest consecutive quarter of top line growth. I am particularly proud of our North American region, which has returned to growth and was up 20% in the fourth quarter. They've done a phenomenal job of rebuilding their pipeline, strengthening customer relationships and positioning the region for commercial execution after the termination of the planned Aurobindo transaction earlier this decade. As a result, the strength of the other regions is fully able to shine through. Generics were up 6%, primarily from volume demand and price erosion, which was below what we experienced last year. Biosimilars were up 26%, aided by the recent launch of Hyrimoz in the U.S. and continued strong demand for Omnitrope across all 3 regions. Sales for the full year 2023 grew 7% to $9.6 billion. Volume contributed 10 percentage points of growth, which were partially offset by price erosion of 3 percentage points. Price erosion is lower than we experienced in prior years and a positive sign that there is an increased understanding about the synergistic relationship between supply security and price. Both Europe and International delivered strong growth of 9%, and North America was up 3% on the year. Core EBITDA for the full year 2023 was $1.7 billion with a core EBITDA margin of 18.1%. While higher sales and product mix were favorable, the gain was offset by anticipated expenses and foreign exchange headwinds, which Colin will discuss in greater detail in his remarks. Our free cash flow was negative $234 million in 2023. As outlined during our Capital Markets Day in June last year, the transition of Sandoz to a standalone company requires significant investments in the first couple of years. Anything like separation and biosimilar capacity. But as we get past this initial period, we expect to be highly cash generative and deliver 2.5x our 2022 free cash flow by 2028. Now let's turn to the business. Generics grew 5% on a constant currency basis in 2023, driven by strong demand for our base business, lower price erosion than previous years and growth from recent launches. The first half of the year was exceptionally strong for many of our cough and cold products and demand for our recent launches such as Apixaban. We were also active on the business development front with the closing of the acquisition of the leading anti-fungal agent Mycamine in the third quarter. In line with our focus on high-growth return opportunities, we're in the process of divesting our Chinese business to Aspen in exchange for several surgical anesthesia products that strengthen our commercial footprint in the European hospital channel. This deal is expected to close in the second quarter. Our biosimilar business grew 15% on a constant currency basis in 2023, driven by strong demand for our existing biosimilars like Omnitrope and new launches as Hyrimoz high concentration formulation in the U.S. and in Europe. As a result, we see a qualitative change in product mix with biosimilars now around 23% in 2023, up from 20% in 2022. We also recently launched Tyruko or biosimilar natalizumab in several European markets and received FDA approval for our interchangeable denosumab Wyost and Jubbonti, and we are progressing with many other of the biosimilars in our pipeline. I'll spend the next few minutes doing a deep dive into several of these biosimilars. Let's start with Omnitrope. Omnitrope or biosimilar somatropin is a great example of how we're expanding access for patients with human growth hormone-related disorders. We are the market leader with a 34% market share, having now overtaken the originator in what was traditionally an originator driven market. This is a biased number that has been on the market for over 18 years and yet is still delivering double-digit growth year-over-year. It speaks to the very long life cycle biosimilars can have once they enter the market. We continue to see strong customer demand for this product and are pleased to be able to supply the market with additional volume. In 2023, we launched -- we announced the launch of Hyrimoz in the U.S. and we were excited to be part of the single largest loss of exclusivity event to date. Our U.S. team has made tremendous efforts to put us in a leading position in terms of market access and payer coverage amongst adalimumab biosimilars. On top of this, we signed a unique multiyear agreement with Cordavis, a wholly owned subsidiary launched by CVS Health to expand the reach of Hyrimoz to patients in the U.S. We made the first shipment to Cordavis in late 2023, and Cordavis is starting to supply product to the market under their own private label. As we expected, the market will take time to form, but we're very encouraged to see that CVS Caremark announced that Humira will remove from its major templated commercial formulas. This means that on April 1 this year, we'll have preferred access to 65% of CVS Caremark's commercial lives. We believe we remain uniquely positioned by offering only adalimumab biosimilar with the same dosing options of Humira, 2 presentations to ensure broad access for patients and a vertically integrated supply chain offering reliability and consistency. In addition, our #1 position outside the U.S. also provides us with millions of patient days experience as well as strong expertise in patient support services. In Europe, where Hyrimoz is already the leading adalimumab biosimilar, we launched a high concentration formulation at the end of last year, bringing an additional treatment option that offers increased convenience and reduced injection volume to patients. Our newest launch is Tyruko or biosimilar natalizumab. Tyruko is the only biosimilar to treat relapsing forms of multiple sclerosis, and we're excited to be the first company to bring this to market. We introduced Tyruko to the Norway market at the end of last year and in Germany and Finland earlier this year. While we are the only biosimilar in the market, we anticipate this will be a slow build as we expand to additional European markets throughout the year and to the U.S. midyear pending approval of our JCV test. We are taking this progressive approach to ensure optimal outcome for each launch given the complexity and product profile of this medicine. Early feedback has been extremely positive. The switch on Tysabri to Tyruko has been swift and seamless, and health care providers value the availability of a biosimilar option in the multiple sclerosis space. At the beginning of 2024, we announced the acquisition of CIMERLI from Coherus and closed the deal on March 1, ahead of our plan. This is a strategic acquisition, which establishes a commercial platform to serve the U.S. retina market and expands our ophthalmology portfolio. The retina market is relatively concentrated in the U.S., and the sales team we are acquiring has a history and a relationship with retinal physicians. This is foundational for CIMERLI to assimilate growth and also for future product launches in this space. CIMERLI is interchangeable with LUCENTIS for all approved indications and has broad access with a strong paid coverage and has been gaining market share since the launch last October. With only 2 approved biosimilars in the market, we are in a strong position to capture share and look forward to providing treatment options to U.S. patients with vision impairment and loss. Due to our global scale and leadership in generics and biosimilars and our broad capabilities, we have become the partner of choice. We can offer partners access to development, regulatory, legal, manufacturing and commercial capabilities to bring an asset to market. This is a unique proposition, which has drawn interest from leading partners such as Samsung Bioepis, Polpharma Biologics and Pharmathen. Partners are not limited to single assets. To ensure continuity to supply for our existing and upcoming biosimilar assets, we've retained Novartis as our manufacturer under highly attractive terms. As we consider our future biologic needs, we signed a development and manufacturing agreement with just EBITDA. On the terms of this deal, we are jointly developing multiple biosimilars. And this enhanced the number of biosimilars in our pipeline today. The agreement also gives us access to disruptive technology that can accelerate the speed and cost of biosimilar development through the use of artificial intelligence and cost efficiency through a continuous manufacturing backlog without capital -- interested capital deployment. Diving into our midterm, we will continue to invest around 9% of sales for development and regulatory with 2/3 of that investment being spent on pipeline expansion as we continue to grow the number of products in our pipeline. Our generic pipeline has over 400 products, covering approximately $170 billion of originated sales. No single product makes of a material amount of our generic sales, so a large scale and robust infrastructure allows us to continually bring new generics to the marketplace. Most importantly, 1/3 of our sales covered are derived from complex generics, which provides an opportunity to shed our generic mix to more valuable and sustainable assets. Today, our biosimilar pipeline is one of the largest in the industry with 24 products covering approximately $200 billion of originated sales. Through a combination of in-house development and partnerships, we've been able to triple our pipeline over the last 5 years. At our Capital Markets Day last June, we published a goal of increasing our share of biosimilars as a percentage of sales from 20% to 30% over the next 5 years through targeted launches, and we are well on the way to achieve this. For the full year 2023, biosimilars as a percentage of sales was 23%, and recognizing that we're still in the very early stages of many of our new biosimilar launches. We published our annual report today, which not only includes our full year financials, but also incorporates our compensation report and our ESG sustainability commitments. As you know, access is at the heart of everything we do. Our employees come to work every day with the goal to serve a social purpose. We find the access for patients to ensure patients can get the medicines they need and when they need them at the right cost. We also have the ambition to ensure Sandoz is a pioneer with diversity, equity and inclusion, and are working on setting targets that will be aligned with management incentives. At the same time, we take our environmental responsibility seriously, working to drive down our carbon footprint and preserving our natural resources. In January of this year, we announced the formal submission of a commitment letter to the Science Based Targets Initiative, the SBTI, which confirms our intent to set science-based carbon emission reduction targets in line with the Paris Agreement goals. We will use the next 24 months to validate our baseline carbon emissions and development ambitious plan to reduce Scope 1, 2 and 3 emissions. We are committed to submitting our plan by the end of January 2026, which will guide our decarbonization targets over the next decade. All our commitments are supported by an underlying strong corporate governance culture. And with this, I will hand over to Colin to discuss our financial results for 2023 and provide our guidance for 2024.
Thank you, Richard. I'm pleased to be with you today to discuss our fourth quarter sales and full year 2023 results. We had an exceptional year and are very proud of all that we have accomplished. We ended the year in a strong liquidity position and entered 2024 with momentum to deliver continued top line growth and margin expansion. As Richard mentioned in his opening comments, due to strong biosimilar growth in 2023, biosimilars increased as a proportion of total sales to 23%, which helps to drive our margin expansion. Our regional sales mix remains about half in Europe, where we hold a strong leading position, and the remaining half divided almost equally between North America and international regions. Starting with sales by business, we are pleased to report fourth quarter sales of $2.5 billion, up 10% versus prior year. Generics delivered solid performance of 6% from volume gains at both existing and new launches and price erosion significantly lower than prior year. Biosimilars delivered very strong growth of 26%, primarily due to continued demand for Omnitrope and the launch of Hyrimoz in the U.S. As Richard mentioned, we signed a unique multiyear agreement with Cordavis and started supplying them with product in the fourth quarter. In addition, we have started to sell our own branded Hyrimoz. But as we have indicated, the biosimilar market will be slow to form until the PBMs in the U.S. remove Humira from formulary.
CVS Caremark announced earlier this year that Humira will be removed from its major templated commercial formularies on April 1, which is a good first step in opening the market to biosimilars. For the full year, sales were $9.6 billion or up 7% on a constant currency basis. Generics delivered 5% growth with contribution from a strong cough and cold season in the first half of the year, strong demand for recent launches and price erosion lower than the previous year. Biosimilars delivered 15% growth with Omnitrope and Hyrimoz as the key contributors. Moving to the regions. All 3 regions performed well in both the fourth quarter and the full year, and we are very encouraged that North America moved from stabilization earlier in the year to strong growth by year-end. In the fourth quarter, Europe delivered 4% growth, primarily from strong demand for Omnitrope and generic products. This more than offset the year-over-year impact from the withdrawal of apixaban midyear 2023. North America grew 20% and benefited from strong biosimilar performance, primarily from Omnitrope and the launch of Hyrimoz. International grew 14% due to volume growth in Australia and Brazil, as well as strong growth in biosimilars. For the full year, Europe and International were up 9% with North America contributing 3% growth. These results further strengthen our status of European champion and are particularly strong given the absence of material launches in 2023. Looking to the P&L, our core gross profit margin decreased as expected by 1.2 percentage points to 50.9%. The favorable contribution from volume and product mix were offset by the anticipated impact of higher input costs and a 1.2 percentage point negative impact from foreign exchange. The core adjustments at the gross profit level amounted to $349 million and consisted of amortization of intangible assets and impairments of $256 million, as well as the rationalization of manufacturing sites and other of $93 million. These adjustments are in line with our definition of core results. The rationalization of manufacturing sites is related to our ambition of reducing the number of internal manufacturing sites from 18 in 2023 to 15 by 2025. Our core EBITDA margin decreased as expected by 3.2 percentage points to 18.1%. I will provide more color on the drivers on my next slide. Core adjustments for EBITDA in 2023 were $829 million. These adjustments were driven by items that were previously disclosed. Legal costs of $576 million, which includes the settlement agreement with the class of direct purchaser plaintiffs in the U.S. antitrust litigation for $265 million, which we announced on the 29th of February 2024. Separation costs of $155 million and the rationalization of manufacturing sites and other of $98 million. Core EBITDA margin was 18.1% for the full year 2023, a 3.2 percentage point decrease from 21.3% in the prior year, in line with expectations. Strong top line growth and favorable product mix from biosimilars contributed an increase of 4.5 percentage points to the margin. This was more than offset by several items, all of which were planned or anticipated. Firstly, 2.4 percentage points due to expected inflation of 10% on input costs. Secondly, 2.3 percentage points as a result of marketing and sales investments to support our top line growth and new product launches. Thirdly, 1.3 percentage points due to standalone costs mainly related to IT. And finally, 1.7 percentage points due to headwinds from foreign currency, primarily related to the strengthening of the Swiss franc and the weakening of various other currencies, including the Canadian dollar and Japanese yen. On Slide 24, I would like to highlight our strong balance sheet at the end of 2023. In Q4, we successfully completed 2 bond issuances in Swiss francs and euros, raising a total of $3.2 billion. We used a large part of the proceeds to repay the bridge facility. Cash and cash equivalents at December 31, 2023, were $1.1 billion, which puts us in a strong liquidity position going into 2024. Working capital increased in 2023, mainly due to an increase in inventory of $0.6 billion to $2.7 billion in total. This increase consisted of $0.2 billion to support the strong top line growth of the business, $0.2 billion from higher input costs and $0.2 billion due to the transfer of inventories from our former parent separation and additional quantities to ensure operational continuity post spin. Our net debt to core EBITDA ratio at December 31, 2023 was 1.8x. We expect this ratio to remain between 1.7x to 2x going forward despite significant planned investments in a number of areas. First, separation costs, mainly related to IT. Second, onetime transformation cost to improve organizational efficiency and deliver 150 basis points of core EBITDA margin over the midterm. Third, biosimilar manufacturing, technical development capability and generics capacity fourth, legal costs, including the antitrust litigation settlement in the U.S. and last, working capital to support our top line growth. We are confident to increase our free cash flow from 2022 to more than 2.5x by 2028, and also to reach a conversion of EBITDA to cash in the 70% range, as outlined at our Capital Markets Day in June last year. Moving to our full year 2024 guidance. Net sales to third parties were expected to grow mid-single digit in constant currencies. Core EBITDA as a percentage of net sales is expected to be around 20%. Now I would like to comment on the phasing in 2024. We expect core EBITDA as a percentage of net sales to be higher in the second half versus the first half. This is due to the fact that biosimilar sales are expected to increase steadily throughout the year and that the benefits from the implementation of operational improvement and organizational efficiency initiatives are skewed towards the second half of the year. Our midterm guidance remains unchanged. Firstly, we expect annual mid-single-digit net sales growth. Secondly, core EBITDA as a percentage of net sales will increase from 18.1% in 2023 to 24% to 26% by 2028. Thirdly, the dividend payout ratio will increase to 30% to 40% of core net income by 2028. I'm now going to turn it back over to Richard to complete our opening remarks.
Thank you so much, Colin. A couple of milestones this year regarding biosimilars are the planned launch of Tyruko in additional European markets and the U.S. as of the first half of the year, and our launch of ustekinumab from 2024 onwards. We also have our first Sandoz Annual General Meeting coming up on April 30 in Basel. Our proxy materials will be sent out by the end of March. And we listed our future sales and earnings call through to the end of 2024. In summary, we are operating in a large, growing and attractive market. We are the global leader in generics and biosimilars, and we're the #1 biosimilar company in terms of market share based on IQVIA data. We are a European champion, and we're well positioned in the U.S. as well as internationally. We have everything on hand to deliver our midterm guidance both in terms of portfolio and pipeline and opportunities to simplify and focus our business. We have the internal resources to execute on our pipeline and the scale to develop and attract strong partners to capture high-value, long-term opportunities. All of this with the objective to deliver superior value creation for our shareholders and for society by pioneering access for patients. With this, I will ask the operator to open the lines for the Q&A. Thank you.
Ladies and gentlemen, we'll now begin our Q&A session. [Operator Instructions] Our first question comes from James Gordon at JPMorgan.
This is James Gordon from JPMorgan. Two questions, please. The first one would be 2024 top line assumptions. So in terms of what are you assuming for biosimilar performance, particularly for North America in terms of the contribution from further launches, what's issue specifically for EYLEA and [indiscernible] including the legal cases? And I think you benefited from some Omnitrope competitor issues in 2023. Does guidance allow for that reversing in 2024? What's the thinking there? And then the other question was the 2024 EBITDA margin. And I heard some comments about biosimilars ramping through the year and operational improvement being more back-end weighted. So how back-end weighted do you think the margin is going to be? If it's 20% for the full year, could it be something like 18% in the first half and 22% in the second half? Or could it be even more extreme than that?
Okay. Thank you, James. First, if I take the first question and then Colin can take the second one. And we guided at the Capital Markets Day that the product launches we anticipate over the next 5 years would generate about $3 billion worth of sales. Roughly half of that we anticipate coming from biosimilars and roughly half of that will come from the U.S.
Now clearly, we're really pleased with the momentum we're seeing in the U.S., particularly in terms of biosimilars. So we would anticipate the biosimilars business to continue to grow far faster than the rest of the business. And that's clearly -- we guided that in terms of the proportion of our business that we would assume to be about at least 30% by 2028 going forward.
Again, on the specific products, EYLEA and Prolia, clearly, the ongoing cases there, and we'll see when we launch those. We've not guided a launch for these this year. So we'll just see how that one flows through. Omnitrope, I think clearly, we benefited from some of those -- the supply disruptions we've seen in the market. And there's a few reflections. We don't see that situation fundamentally changing certainly in the short to midterm.
And also bear in mind, these patients are generally fairly sticky once a child is started on these therapies, they generally stick with them. So I don't see any material risk of the momentum in that business, certainly in the short to medium term. And we'll see what happens beyond that. Colin, do you wanted a bit to talk about the margin?
Yes. Really, there are 3 drivers for the margin expansion in 2024. Firstly, volume the mid-single-digit top line. The mix shift into [ Bio ]. We see a steady increase in biome during the course of the year.
And then thirdly, the organizational efficiency and operational improvement initiatives. At the Capital Markets Day, we said that the organizational efficiency could be front-ended in the plan period. We set procurement, which represents 200 basis points of this 350 basis point operational improvement expansion, we could get some early savings if we have the focus. And clearly, we need to analyze and implement those initiatives in the first half of the year to then get the benefit in the second half of the year.
So it's really those 3 things: the continued increase in the volume, the shift into bio and the fact that the initiatives will be implemented in the first half of the year, given the benefit in the second half.
Our next question is from Harry Sephton at UBS.
Brilliant. So the first question is simply on the higher most performance in the fourth quarter. Just wanted to gauge how much of that you expect for the stocking effect to CVS that you wouldn't expect to be recurring into this first quarter of next year or this year?
Second question is on the proposal from the U.S. government budget 2025, which is proposing to allow biosimilar substitution without the need for an interchangeable designation. Can you maybe give your view on how this changes the biosimilar in the market in the U.S. and maybe the potential effect you expect on your portfolio?
Higher most performance. I mean, that was, I think is stocking. What we effectively fulfilled our contractual orders to Cordavis in Q4. And what's encouraging, actually, we're now replenishing those orders as we go into Q1. So I don't really see any stocking effect purely just supplying the demand that we could actually had to supply to Cordavis. So hopefully, that answers that question.
The interchangeability one, it's, a, we've always said look, interchangeability in a sense is just one factor. The U.S. because all seems to have made this quite a complex. Because actually, it's not interchangeable to all products. What their designation meant was interchangeable to a particular product. Whereas in Europe, all biosimilars are seem to be interchangeable with each other and the originator.
The way I interpret this, with the U.S. is much more moving to a more European light framework. So I think generally, I think that is a positive. It's a positive signal from the market. It gives confidence to patients and prescribers. How material that will be, it's difficult to estimate. But certainly, it's not having a negative impact in the mid- and long-term outlook and sustainability of biosimilars in the marketplace. Thank you.
Our next question is from Vineet Agrawal at Citi.
One on margins. The decline in margins was in line with the guidance, but the expectation was with about 5% top-line growth. Now with higher-than-expected growth on revenues, just trying to understand why the margins came in at the low end of the guidance. Are there any particular factors you think had a larger role in that mix, particularly given that biosimilars was very strong, which should have had a very strong positive mix impact?
And then just a quick one on Cordavis partnership. Now since AbbVie has also partnered with Cordavis, just wondering it impacts in any ways your agreement with the company?
First of all, I take the second question first, and then I'll let Colin comment on the margin. No, I mean, look, the deal with the originator really is giving that option to patients, but it clearly means with a much higher co-pay. So we don't see that either changing the nature of the relationship we have or having any material impact on the business.
And as I said earlier, I think we're also very pleased in terms of the designation status are changing from the 1st of April, and given that we have probably more lives covered than any of our competitors, I think we're in a very strong position, again, being vertically integrated having the patient experience and the support. So I'm very confident in terms of how we build this business as a franchise quarter-on-quarter going forward. Colin, do you want to talk about the margin?
Yes. So your question as to why was the margin not stronger? Well, it is true we have higher top-line growth, but we needed to invest slightly higher marketing and sales to actually support those biosimilar launches. That's one.
And secondly, FX, as you will have seen, at a 1.7% impact on the EBITDA. The $18.1 million that was reported is net of that FX impact. And it was -- they were somewhat higher than we anticipated initially. But that was due to known reasons, mainly the strengthening of the Swiss franc and then some key currencies slightly Canadian dollar and the Japanese yen weakened against the dollar. But as you know, our top line is on a constant currency basis, but our EBITDA commitment is net of any currency impacts.
Our next question is from James Vane-Tempest at Jefferies.
Just 2, if I may, please. Firstly, on operational efficiencies. I think you talked about what is to halve the number of suppliers from around 700 to 350. Just wondering whether you can give us an update in terms of the quantum of that and how you're progressing and when we can maybe see some changes or if you can update us on that number, please? And then the second question is just on the margin. Going on the guidance, going from 18% to around 20% is quite a gap up. We've always sort of talked a little bit about phasing. But I was just wondering if you can give us any commentary on what you're expecting on U.S. pricing, I guess, is the benefit or the headwind was 3% around the 6% in 2022, what are you assuming coming into 2024?
And also, M&A contribution. Obviously, given that [ Kimberly ] asset, how we should think about contribution from guidance in '24 as well, please?
Okay. So the operational efficiency, I think there's a number of levers here. I mean we've already started on that journey. I think we recently announced we were closing one of our manufacturing sites, and then we're moving those assets to other much lower costs of suppliers particularly on the print [indiscernible] side, the journey in terms of rationalizing our supply network is well underway.
We don't give specific numbers, but I'm very pleased with the progress that we're making. And also part of that is simplifying the overall complexity of our business and using that as an opportunity. There's also a significant number of other areas. We're not seeing really the input -- any additional input inflation going into this year, which is giving us a very solid base to move forward on.
As Colin already mentioned, there's a lot of procurement opportunities that we're identifying and working through. We're also working through the broader organization, looking at ultimately transforming ourselves from coming from a big pharma organization to becoming a lean generics business. So delayering the business, really thinking about how we set ourselves up properly. That's all [ totally ] to exiting out of the TSA from Novartis as early and as quickly as possible and using that to drive organizational change.
So I think there's a bunch of levers that we're focusing on. U.S. pricing, I think you're right. Again, we don't break it out by region. Historically, we've always seen about 5% price erosion. Last year, we saw about 3%. In our plan assumptions, we kept it at 5%. I think that's prudent. Now clearly, we are seeing a shift with payers and governments in terms of sustainability and supply security becoming much more important rather than just a few cents on the dollar we squeezed out of the business. So I'm optimistic.
But again, I've always had focus on various strategy. So we've consistently guided on that. And then M&A, again, I think at the Capital Markets Day and subsequently, we've always assumed that we would do about 1 percentage point of growth coming from fairly low levels of M&A. So certainly, the CIMERLI deal that we've done, I would say, falls into that category. So it's very much built in terms of our guidance.
Our next question is from Folashade Oyewole at Redburn-Atlantic.
I've got a couple of questions, actually. Just one moment. Sorry, can you hear me now?
I can now, yes.
Okay.
I can hear you.
Perfect. Could you just give a little bit more information on the pricing trends across the region and segment, particularly in U.S. generics? And second question to do with the pipeline. With the key biosimilars now being launched, will you disclose the next assets in the pipeline?
Again, we've never broken down pricing trends by regions because there's so many variables, it will make things so complicated. So we will only ever break it down at a global level, which goes back I think to my earlier comment, we've always seen traditionally plus or minus about 5% price erosion. But because of a number of dynamics, certainly this last year, we saw it closer to 3%. And I think that's consistent both in Europe and in the U.S. So I think it's a very similar dynamic and really linked to, I guess, security of supply or instability of some of our competitors and failure to supply.
So we've been able to take the price. And I don't see that similar trends changing in the short term. Now whether we could -- that maintains over the medium and long term. But certainly, the conversations that I had with government, with Congress, with European governments is not much more around how can we assure supply. But ultimately, there needs to be a win on both sides in terms of our margin or supporting our business to allow us to make sure that we have the right inventory and the right investment.
We've invested significant lots of money, something like antibiotics. We've invested nearly $300 million to increase our capacity, and we're looking at expanding other areas where we see opportunities and we can support that business.
And then your second question. Sorry, would we break down individual assets? Again, because, I guess, we have so many assets and no one product becomes material in terms of all of the others, we tend not to do that. I tried to give you a little bit more color around products like Omnitrope, more around showing how sustainable biosimilars are over a longer period of time, but it's not our intention to break it down on the biosimilar side.
But clearly, we'll give individual product information in terms of launches on the biosimilar side because that's public information because all of those assets have to go through Phase III studies whereas small molecules don't go through a Phase III studies. And again, that information isn't public, and we don't want to make our lives any harder with our competitors than it's already is.
Our next question is from Alistair Campbell at RBC.
Just a couple. Just a question on CIMERLI. It's a problem that comes with a phase and you can pay away, I think. So just to confirm that, that product. Is it margin dilutive or margin accretive, in your view, as you fold that into the business?
And also, if you hear us talk about not just taking share from Lucentis, but also potentially taking share back from off-label Avastin. Is that something you expect to happen? Is that something you're seeing on market? And then just 1 question on the pipeline. It looks like you just started a Phase III for a biosimilar Keytruda. So from that point of view, it looks like you're going be the first and one of the first since the clinic. So just ask on that in terms of the long-term outlook, what your view is on Merck's subcutaneous version? And what sort of threat back could pose in terms of shifting the market?
Okay. So yes. CIMERLI and broadly, it's accretive, not dilutive. So again, we're pleased with the acquisition. Also very much just giving us a platform to launch further biosimilar in this space. So I think it makes -- clearly, it's bang on strategy. It strengthens our U.S. business, it brings another biosimilar. It supports the growth, supports the margin and also, it gives us incredible salesforce to allow us to then bring other assets in the future to that space.
I mean, it's too early to say. I mean, literally, we closed the business a week ago. So I think it's a little bit too early to say and my confidence level and capability to switch from other molecules to CIMERLI. So I perhaps going to park that 1 for a little while. And CIMERLI with Keytruda, I mean, it's still very early days. I can't really comment on how we see this evolving. Obviously, it's an exciting asset. We're pleased to be in that position. But again, it demonstrates our technical capability and our regulatory capability, and we'll see what happens, when we get closer to the launch then.
Our next question is from Niall Alexander at Deutsche Bank.
It's Niall Alexander from Deutsche Bank. Two, please. I'm just wondering if any point in the future you'll provide a split in the P&L more so for biosimilar and the generics the [indiscernible] like your view of what margins we're seeing between the 2 segments. That was the first question.
And the second question, more on STELARA on the inflation rituximab. So STELARA has been selected for the price reduction list upcoming. So potentially see some price reductions there. And it would be good to get your views on the potential implications on your biosimilar launch, which is to take place from 2025 and then beyond?
Yes. Again, we don't segment report because ultimately, we run our business -- we don't run our business in that way. So we wouldn't break out the 2 P&Ls to show bio and small molecules. So that's not something that we do internally, and it's not something we would hope to do expose externally.
But clearly, I would say bio is consistently more profitable than small molecules, at least 10% gross margin higher than the equipment on small molecules and clearly for a much longer life cycle. So worth considering that. STELARA, I think that the price reduction, ultimately, we would expect to see a price reduction from the originator anyway and probably a similar strategy to what you've seen with HUMIRA in the terms of filling the channel. So I think I would anticipate a relatively similar dynamic and again, a build rather than a bang over many quarters.
Again, I think we have credibility both in terms of the space, I think having a strong position with adalimumab is going to be beneficial with payers and with prescribers. We have the infrastructure to support it. And similarly, when we launch in Europe, let's not forget in Europe, we are the largest immunology company in Europe. So we have a phenomenal opportunity to extract a significant amount of value with the customer base that have regular confidence in us as an organization.
Our next question is from Victoria Lambert at Berenberg. .
The first one is just about cost inflation. In December, you indicated that cost inflation was tracking close to 0. Is this still the case? Is this being supported by headcount reduction, falling energy costs? And are there anything else that's driving this lower inflation trend?
And then my second question is just in January, you highlighted at a conference that you are working on generic GLP-1s in the complex pipeline. Do you still expect to launch your generic Victoza in the first half of this year? Are you working on other generics like Saxenda? And are you maturing this in-house or using your India-based partner?
Thanks, Victoria. So Colin, do you want to take part of the question?
Yes. So you're right, Victoria. What we've guided overall for 2024 is at 0 cost inflation versus 2023. And that's really being driven by energy warehousing distribution. Those elements are down and driving the overall guidance that we're giving around about 0 increase in 2024.
And again, we wouldn't just pay because this is a certified classes for molecules, we tend not to -- we wouldn't disclose specific molecules. I guess I would point out that no one has yet successfully filed and got an approval for Victoza as a generic. So we'll see how that market evolves. But it's really not one of the major GLP-1s. It was really one of the first generation products. So I don't see that as a major opportunity.
In terms of our GLP-1, I mean, clearly, we disclosed that clearly, we have partnerships on these -- on some of these. So clearly, we partnered with former friend, a very credible supplier partner. We've worked with them on numerous projects. So we have a partnership with them. And some of those also we're developing in-house because we have that capability.
Again, we wouldn't necessarily disclose whether it would make the API in-house or would use a third-party. But again, clearly, as we're a leader in biosimilars, we would aspire to become a leader in the GLP-1 space over the coming years.
Our next question is from Thibault Boutherin at Morgan Stanley. .
First one on biosimilar, just about the -- if you could clarify the IP situation. I think you're mentioning that the launch is only related to kind of logistical, I think, around the approval of the JCV test. So just to make sure that the IP station is solved, are you ready to launch [indiscernible] on biosimilar in the U.S.?
Second question, if you could give us an update on the commercial situation for backfill custom in the U.S. I think we saw sales kind of declining in the second half of last year. There was a sort of shift in commercial strategy. So if you could just update us here? And should we expect sales to come back some time this year?
And then just last question, if you could give us a little bit more detail on the situation with CVS. So you mentioned they are processing the switch to biosimilars from April by delisting the brand. Can we assume that all of CVS covered lives are going to use Cordavis Biosimilars, or at least a vast majority of them? And then if you could just comment regarding this as well on the -- if you have any visibility on the split of supply between you and AbbVie to Cordavis would be helpful.
Yes. Thank you. So I guess, 3 questions. So I mean, look, you're right, we're waiting for the approval of the JCV test. We overturned the preliminary injunction in the U.S. We had a very strong outcome on that.
On the basis of that, we would confidently launch potentially theoretically at risk. But there's no reason, once we get the JCV approval, that there is nothing else to stop us from launching. So we're just basically waiting for that in the U.S. And we've already started rolling this out in Europe. And I think the first market we launched this was in Norway. We've already taken more than half of the market in that country.
So again very pleased with the adoption and pleased how that's rolling out. But it is a complicated product, and it's important that we work closely with payers and physicians to roll that one out.
[indiscernible]. Yes, I mean we talked about a little bit of that last year. We effectively rebased the business. Now that's starting to build again, and that will wash out as we go through this year and then come back into growth really as we get into quarter 4 this year from the point that we effectively rebased it in the market last year.
And then CVS, yes, it is too early to call. I mean, clearly, I'm very pleased that they made this decision to effectively switch patient lives covered. I think that's roughly about 65% of lives covered within CVS. It will then be off to be offered with the biosimilar as a preferred product. We'll see how they uptake goes on that, but I think this is again a step in the right direction.
And we're pleased that, clearly, we're in a very strong position to capture a significant proportion of that volume with CVS going forward.
The next question is from Florent Cespedes at Societe Generale.
Florent Cespedes from Societe Generale. 3 quick ones. First, on the growth. Could you come back on the breakdown of the growth for the full year and the fourth quarter in terms of volume, prices and portfolio that will be very -- would be wonderful?
Second question on natalizumab biosimilar. Could you give us a little bit more color on how these products, as you are the only product on the market -- biosimilar on the market, is it easier in terms of pricing? Do you have better price with this product versus all the drug that you have on your portfolio? That's my second question.
The third question, a naive question on [indiscernible] is accelerating. Is there any reason to see acceleration of prescription of these product, given the fact it's on the market for many years? So some color on that would be great.
Fine. Colin, do you want to take the quarter 4 growth question?
Yes. As Richard said, we don't break down pricing by region or product. But overall, in Q4, it was a similar trend to the whole of 2023 that the price of [indiscernible] was approximately 50% below what it had been in the previous year.
And we saw strong volume growth due to the Cordavis launch. And in addition, the Mycamine sales coming from the Astellas deal and the mature brands that transferred over from Novartis supported the 10% growth in Q4.
And then on natalizumab, Yes, I mean, look, at the end of the day, we're in the business of selling alternatives to the originator. And clearly, if there's more competition, then the prices get driven down. If there's less competition, prices are less -- there is less pressure on price. I mean we will -- I mean, at the end of the day, when we launch a product like natalizumab, we need to offer it at a price that is attractive to payers and patients depending on the market.
I can't give you the specific number. But certainly, it wouldn't be anywhere near the level of discount that you would expect to see when there's high levels of competition in any particular market. So we're very pleased with natalizumab. As I said, we don't see anybody coming into this space, certainly in the midterm. And it's probably as close as an originator launch that I'll ever get in my career. So I'm very pleased with it.
And then your question on Omnitrope. I mean, I think, look, clearly, we've just consistently been on the market. Why have we seen an inflection over the last 2 years? Ultimately, the 2 main providers have moved some a lot of their capacity away from human growth element to support GLP-1 supply, and we've been able to consistently support patients and bring what is a critical medicine for kids in the market, when some of the originators have made the decision to deprioritize this supplied. So clearly, we benefited in that, but I think it's also important that we continue to support those patients.
And as I said earlier into one of the earlier questions, I think once you capture this market, it's generally fairly sticky. Parents don't like to switch products, so patients once they're step -- start established on this. So we generally keep those lives for quite a long period of time until they've matured. So I'm pleased with the growth and see no real reason why that should change certainly in the short to midterm.
Our next question is from Edouard Riva at ZKB.
Yes. Edouard Riva from Zürcher Kantonalbank. I would say it's fair to say that we achieved to defend the volume on the [ Humira ] in 2023 quite fairly. And my question would be -- my first question would be, did this correspond to your expectations going into 2023?
Or are you counting on a higher fragmentation at the beginning? And I'll take my second question will be closely related is -- and how should we take into account this fact for the launch of next products such as Erelzi or STELARA, I mean, biosimilars of Erelzi and STELARA?
Yes, it's -- I mean we've always guided that this was a build, not a bang. And I think actually, in many ways, I'd prefer it that way anyway. If it was just a big market switch overnight, I think that makes it much, much less attractive. I think budget from the country president in the U.S. will almost decline, but also describe it's much more like an originator cell. Because you need to convert patients, you need a salesforce, you need to work with physicians. So we're pleased how that's building.
I mean, clearly, I think we have more lives covered with the relationships we have with CVS and PBMs than I think any of our other competitors. No one else really has got a vertical integration, both presentations, the millions of patient years and the relationships that we have. So we're very encouraged that we're in the right position to start capturing share. As I said earlier, we've already shifted to Cordavis and we're now continuing to shift. So we're seeing that flow through. So I'm very pleased.
So I guess that will continue to evolve. And honestly, I think subsequent launches, I think I said earlier on, I think ustekinumab will probably behave in a probably similar way. I would expect the originator to follow very relatively similar tactics. And again, we'd expect the market to evolve and build rather than rapidly convert like you would traditionally see with a small molecule generic.
I think we're pretty much close to the top of the hour. I think we've got time one last question or not? We're going to wrap up.
So again, look, thank you all for your interest, your excellent questions today. I look forward to seeing you all and talking again in future quarters. And thank you so much, and have a good rest of the day.
Thank you.
This concludes today's call. Thank you, everyone, for joining. You may disconnect.