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Earnings Call: Q3 2023

Oct 24, 2023

Operator

Good afternoon, 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.

Karen King
Head of Global Investor Relations, Sandoz

Welcome to Sandoz nine months 2023 sales conference call. Earlier today, we issued a press release and posted a supplemental slide presentation on our website to enhance 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 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 not be comparable to other similarly titled measures of other companies and have limitations as analytical tools, and should not be considered in isolation or as a substitute for the analysis of our operating results as reported under IFRS. Non-IFRS measures are not measurements of our performance or liquidity under IFRS. They should be considered as alternatives to profit for the year or any other performance measures derived in accordance with IFRS. For discussion purposes only, in today's presentations, sales refer systematically to net sales to third parties, excluding sales to Novartis Group, and our comments on growth are expressed in constant currencies. With that, I will now turn the call over to our CEO, Richard Saynor.

Richard Saynor
CEO, Sandoz

Thanks, Karen. It's an absolute pleasure to welcome you to our first sales update as a standalone company. Going forward, we will report full financial performance for the half year and the full year. For the first three and nine months of the year, we will provide a sales update, which will give you an opportunity to see how we're progressing against our sales guidance. Today, I will start with the business highlights over the past three months and then turn it over to Colin, who will discuss our nine-month sales and full year outlook. I will wrap up with closing remarks, and we will then open up the call for a Q&A. We continue to see momentum in our business, which translates to strong nine-month sales of growth 6% in constant currencies.

These results were driven by ongoing strength in Europe and international markets, and the stabilization in North America, and continued strong demand for our biosimilars. I will provide more details around our sales in a few moments, but we'll start with our recent strategic milestones. At the Capital Markets Days, we highlighted the multiple drivers of top-line growth for Sandoz. A key driver are the near-term biosimilar launches, and I'm excited about the advancements that we've made over the past months. First, Hyrimoz, or biosimilar adalimumab, was launched in the U.S. as planned on July 1, bringing the first immunology biosimilar to market in the pharmacy benefit space. We are excited to be part of the single largest loss of exclusivity event to date.

Our US team has made tremendous efforts to put us in a leading position in terms of market access and payer coverage amongst the adalimumab biosimilars. All three major pharmacy benefit managers, Express Scripts, Optum, and CVS Caremark, have announced coverage for Hyrimoz in the US, and we have more lives covered than any other competitor. On top of this, we've signed a unique multi-year agreement with Cordavis, a wholly-owned subsidiary launched by CVS Health, to expand the reach of Hyrimoz to patients in the U.S. Hyrimoz is expected to be released and commercialized by Cordavis under their own private label, beginning in the Q1 of 2024. As we expected, the market will take time to form, particularly in the absence of Humira being displaced from payer formularies.

However, we believe we remain uniquely positioned by offering the only adalimumab biosimilar with the same dosing options as Humira, two presentations to ensure broad access for patients, and vertical integration for supply, reliability, and consistency. Our number one position outside of the U.S. also provide us with millions of patient days of experience, as well as strong expertise in this patient support services. We're also looking at enhancing our growth with bolt-on acquisitions. In August, we completed the acquisition of the leading antifungal agent, Micamine, from Astellas, reinforcing our global leading anti-infective portfolio. Sandoz is a leader in the large and growing anti-infective market. We are the last major vertically integrated anti-infective producer in the Western world. Micamine is a therapy of choice in hospitals and in intensive care units worldwide, a proven prophylactic in hematology and oncology patients, and widely used in organ transplants.

This acquisition reinforces our global hospital offering and leading anti-infectives portfolio. Another pillar of our strategy is our focused strategic investments to enable the future development and supply of biosimilars. This will help us rapidly meet the rising global demand for biosimilars and to make an even more meaningful contribution to the long-term viability of healthcare systems around the world. At the Capital Markets Day in June, we talked about a $400 million investment in Slovenia to build a world-class biosimilar manufacturing facility, as well as a EUR 25 million investment in the expansion of our biosimilar development center in Germany. In July, we announced an additional strategic investment of $90 million to build the state-of-the-art Sandoz Biosimilar Technical Development Center in Slovenia by 2026.

This new end-to-end drug substance and drug production development center will be an important step in expanding Sandoz's biosimilar technical development capabilities. Our commercial scale, combined with development and regulatory capabilities, make us a partner of choice in the industry. This status has been reaffirmed with several recent agreements. Earlier this year, we signed a multi-year partnership with Just Evotec Biologics, covering the development and manufacture of multiple biosimilars. This gives us access to disruptive technologies complementary to our existing capabilities. Over the summer, Tyruko, or biosimilar natalizumab, received FDA and EMA approval. If you recall, Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics, and has the right to commercialize and distribute the product in all markets.

Tyruko will be the only biosimilar to treat relapsing forms of multiple sclerosis, and we're looking forward to being the first company to bring this product to the market at the latest in the first half of next year. More recently, in September, we entered into an exclusive deal with Samsung Bioepis to commercialize their biosimilar ustekinumab in the U.S. and in Europe. This agreement further strengthens our position in the immunology space and expands our pipeline to 25 assets. Before jumping into the sales results, I would like to come back to a key milestone in the history of Sandoz. Just three weeks ago, on October 4 th, we successfully completed the spin-off from Novartis and became an independent standalone company. Sandoz shares are now listed and traded on the Swiss Stock Exchange, and ADRs are traded on the OTCQX in the U.S.

I would like to thank all our Sandoz employees for their hard work leading up to the spin, as well as our shareholders and analysts for your interest in our business. The successful listing marks the beginning of a new era for Sandoz as a standalone global leader and a European champion in generic and biosimilar medicine space. With this, I will hand it over to Colin to discuss our sales update and full year outlook.

Colin Bond
CFO, Sandoz

Good afternoon, everyone. My name is Colin Bond. I am the CFO of Sandoz. It is my pleasure to be giving you our first sales update as a standalone company. Today, Novartis published their Q3 results, with Sandoz reported in their financial statements as discontinued operations. Our comments today will be focused on our nine-month sales, as Richard indicated. I am very pleased that Sandoz succeeded in delivering a quarter of mid-single-digit growth. In the first nine months of 2023, net sales were $7.1 billion, up 6% versus prior year at constant currencies. Volume contributed nine percentage points of growth, partially offset by price erosion of three percentage points, which is lower than prior year. The growth was driven by ongoing strength in Europe and international markets, continued stabilization in our North America market, and strong biosimilar performance.

Our biosimilar business share increased by one percentage point as a result of the biosimilar growth, moving from 22% to 23% of overall sales. Moving to our two businesses. The generics business was up 5% in constant currencies, driven by recent launches and volume growth. The H1 of the year was strong for cough and cold products, which contributed to our year-to-date performance. In addition, we saw continued demand for many of our recent launches. The biosimilar business grew strongly in the first nine months, up 11% in constant currencies. Growth was broad-based across the biosimilar portfolio, with Omnitrope and Hyrimoz being the largest contributors. This shows the strength of biosimilars in the market, as both of these products have been available in Europe for many years, yet continue to gain momentum and expand patient access.

In fact, data tells us that adalimumab market in Europe has grown at a CAGR of 14% since the launch of biosimilars in 2019, compared to 9% in the four years preceding the biosimilar launches. Looking now at the regions, Europe now represents roughly half of net sales, with a three percentage point share increase compared to prior year on the back of strong growth across both generics and biosimilars. Europe showed double-digit growth in the first nine months. The volume growth was driven by a combination of a strong cough and cold season in the first half of the year, continued demand for recent launches and biosimilar performance, particularly from Omnitrope and Hyrimoz. North America continues to stabilize ahead of the forthcoming biosimilars launches. The portfolio demonstrated stable performance, with price erosion lower than the previous year and strong growth of Omnitrope.

International showed continued momentum, driven by demand in key markets, including Australia and Brazil. Key biosimilar products reported strong double-digit growth in the region. The solid results were aided by price erosion lower than prior year. As announced shortly before the spin, Sandoz received two solid investment-grade credit ratings from Moody's and Standard & Poor's. We expect to keep a net debt to core EBITDA ratio in the range of 1.7x to 2x , which places us in a strong position among our peers. We target to refinance the bridge facilities as soon as possible, subject to market conditions. Now for our full year 2023 outlook. On the back of the strong sales performance in the first nine months, we are confirming our 2023 guidance, which we first outlined at our Capital Markets Days last June.

We expect mid-single-digit net sales growth at constant currencies and core EBITDA margin as a percentage of net sales of 18%-19%. As part of our capital allocation priorities, we commit to paying a dividend in 2024 of 20%-30% of 2023 core net income, subject to shareholder approval at our first annual general meeting next year. I am now going to turn the call back over to Richard, who is going to make his final remarks.

Richard Saynor
CEO, Sandoz

In closing, I want to highlight a few upcoming initiatives. We will continue to focus on near-term biosimilar launches. Following the launch of Hyrimoz in the US, we're expecting to launch the high concentration formulation of adalimumab in Europe by year-end, which will aid in extending the life cycle of the product. I also talked about our excitement of bringing Tyruko to market following the approval by the FDA and the EMA. Sandoz natalizumab will be launched as the first biosimilar to treat relapsing forms of multiple sclerosis, and we expect to be the only biosimilar available in the coming years. On the regulatory side, we're expecting the FDA approval for denosumab, which is one of our pipeline biosimilars in bone disease and oncology. Regarding corporate events, our full year results will be published on March 13th 2024.

Subsequently, the first annual general meeting is scheduled on April 30th 2024. To wrap up, our underlying business is performing well, with eight consecutive quarters of top-line growth. We're making progress with our regulatory milestones, and we're bringing new products to the market. We continue to see strong demand for our biosimilars and are investing in our future growth. We look forward to our year-end call, where we'll cover our full financial performance and provide guidance for the full year 2024. Finally, I want to thank all our employees once again for delivering strong sales performance year to date and delivering on our clear purpose to pioneer access for patients and to become the world's leading and most valued generics and biosimilars company. We are now more than happy to take your questions, so let's open up the line for Q&A.

Operator

Ladies and gentlemen, we will now begin our Q&A session. If you have a question, we ask that you please use the Raise Hand function at the bottom of your Zoom screen, or if you have dialed in, please press star 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 in the Zoom app or via telephone, press star nine. Thank you. In a moment for the first question. Our first question comes from Thibault Boutherin from Morgan Stanley. Please unmute yourself and ask your question.

Thibault Boutherin
Equity Research and Executive Director, Morgan Stanley

Hi, can you hear me?

Richard Saynor
CEO, Sandoz

Yes, we can.

Thibault Boutherin
Equity Research and Executive Director, Morgan Stanley

Okay, perfect. Thank you for taking my questions. Maybe the first one on Tysabri biosimilar. I saw in your release that you mentioned the H1 2024 launch, I think, for both U.S. and Europe a nd so I just wanted to know if you could confirm the IP situation in Europe and in the U.S d oes it reflect your confidence in the settlement with Biogen, or does it simply mean you are ready to launch at risk in the first half? M aybe my second question on the biosimilar Humira situation. I mean, obviously, AbbVie has done an incredible job in terms of locking markets biosimilar so far s o just trying to understand, you know, what do you think is going to unlock this market?

Because it's, you know, it's difficult for us to understand what prevents AbbVie from adopting a similar strategy in one year, two years, three years s o it's the question of driving down net prices to a point where it's still being interesting for them. J ust trying to understand driver of market opening for Humira in the U.S.

Richard Saynor
CEO, Sandoz

Okay, thank you. Thank you so much for your question. I guess two parts. Tysabri, yeah, from a European point of view, again, we're confident in terms of the patent position, and we're confident that we will launch in the H1 of next year. In the US, again, we had a strong outcome with the PI injunction hearing, again, we had a strong outcome in terms of that court case s o clearly we would certainly consider launching at risk, coming to the market, given the strength of that court case and our strength and belief in the patent position. A gain, excited to bring a product to the market where we see a real need for patients, but also the reality is probably no other biosimilar coming into that space.

Your question around adalimumab in the U.S., I mean, it's an interesting one. Clearly, at the moment, I think something like 97% of coverage is still on the originator product. Certainly, the feedback we expect as we go through next year, and we think we've guided this pretty much from the beginning, is that as formularies rotate round, as payers frameworks change, we expect that to start moving, and we're starting to see some momentum. I guess, you know, what I'm happy about is today that we've got more lives covered, so all three of the PBMs have us listed s o that gives us extremely broad coverage.

But also on top of that, we clearly with the partnership with Cordavis, that effectively that means that we have contractual volumes that we have to deliver to them, which also will underpin our business both in 2023 and into 2024 and beyond. I think we've always guided this will be a build rather than a bang. What we are seeing, I guess, is more and more, I guess, new patients rather than necessary switch patients at this point being put on the product s o I'm confident that we'll build a very attractive franchise, over the coming quarters.

Thibault Boutherin
Equity Research and Executive Director, Morgan Stanley

Thank you.

Operator

Our next question is from Simon Baker at Redburn Atlantic. Please unmute yourself and ask your question.

Simon Baker
Partner and Head of Global Biopharma Research, Redburn Atlantic

Thank you for taking my questions. I've got a few, if I may, please. Firstly, on the split of generics and biosimilars by region. At the Capital Markets Day, you said that the generic biosimilar split for the U.S. was 80/20 in 2022, and 88/12 in international. Is that still the case for the nine months of 2023? A lso, at the same time, you gave an aspiration of reaching 70% of sales from biosimilars and complex generics. Could you give us the where we are today in terms of that split? T hen I too have a question on adalimumab pricing. Within the U.S. market, you obviously weren't first, but arguably you are best, given the formulation that you've got.

I just wonder how that works out in terms of pricing versus the previous players. We've seen a lot of data, particularly from Amgen, about the evolution of price as additional entrants enter the market. Do those dynamics apply here, or does the fact that you have a differentiated offering give you greater pricing power in that space? Thanks so much.

Richard Saynor
CEO, Sandoz

Richard, perhaps do you want to take the first two, and then I'll take the last one, if that's okay?

Colin Bond
CFO, Sandoz

Yeah, happy to do that, Richard. O n a year-to-date, nine months on which we're actually giving the guidance today or the update today, 22% is our year-to-date bio sales, and 78% on generic. We break down the sales then by region, as we've committed to doing 26% on international, 21% on North America, and 53% on Europe, but we don't actually give a breakdown within the region into generics and biosimilars. Richard, over to you.

Richard Saynor
CEO, Sandoz

Yeah. Thank you. On the adalimumab pricing, I mean, clearly at the moment, you know, it's a market that's being negotiated. I guess we've both gone in as a high price strategy or a high list price strategy and a low list price strategy, depending on what ultimately our customers want. I guess I can come back to ultimately whatever pricing at the moment we're seeing in the U.S. on aggregate, is still significantly higher than pretty much anywhere else in the rest of the world, so this is a highly attractive market. It's an interesting question. I mean, ultimately, we have a great product. We have a really good device. In many ways, we think it's better, you know, probably the best device, available to patients.

Certainly, given the intimate relationship between patients and product, we do think this product has the potential to be sticky b ut equally, I'm not naive to the fact that ultimately it's what's on formulary and what insurers are prepared to pay for s o, we have to be competitive in that market. W hen you look at that from that lens, ultimately, you know, you need several things to be successful in this market. You know, well, we're number one ex-U.S. We have millions of patient days data. We're vertically integrated, so we have a good cost of goods. We have both strengths, and we have a great delivery device. Nobody else really has that combination of things. Either they're sharing their margin with somebody else, they only have one presentation, and certainly, they don't have the data package that we have.

We're confident that we can build this franchise going, you know, quarter on quarter, going ahead.

Simon Baker
Partner and Head of Global Biopharma Research, Redburn Atlantic

Just a quick follow-up. I think you may have missed the, and I don't know whether you want to answer it, the question on, the current percentage of revenues from biosimilars and complex generics versus the 70% aspiration.

Richard Saynor
CEO, Sandoz

Well, I think the 70% was very much, you know, that we've guided over the next five years s o what we've said over the next five years, we would launch about $3 billion of new, new assets, of which $1.5 billion will come from biosimilars. T hat would give you a sense of, okay, currently our business is, what? 22% biosimilars, growing at mid-teens, on which we're going to then launch $1.5 billion of new, new biosimilar business s o you can see that the proportion of biosimilar business is gonna grow quite strongly over the next few years. We don't actually break out any further in terms of complex and simple generics.

That's something we may need to think about in the future, but certainly at the moment, all we do is break out between the two, and I think we've given enough information to sort of give a sense of what proportion, certainly over the next three to five years, will be biosimilar.

Colin Bond
CFO, Sandoz

Thanks so much.

Operator

If you would like to ask a question, please use the Raise Hand feature at the bottom of your Zoom window. Alternatively, if you have dialed in, please press star nine to raise your hand. Once you've been invited to ask your question, please unmute and ask your question. Our next question is from Graham Parry from Bank of America. Please unmute yourself and ask your question.

Graham Parry
Senior European Pharmaceuticals/Healthcare Equity Analyst, Bank of America

Great, thanks for taking my question. F irst one's on the North America stabilization. I know you don't want to give specific numbers here, but can you just help us directionally in what's happening specifically within the U.S. now in the quarter? Is U.S. in constant exchange rate still declining, is that flat, or is it actually now growing? Secondly, on FX, I think you guided, you know, full year guidance is at constant currencies. Looks like FX has had less of a negative effect in the quarter a nd if rates stayed unchanged for the rest of the year, what do you think the FX impact on your top line would be for the full year of 2023? T hen a question on cough, cold, that obviously helped first half growth rates.

Can you just remind us, is there a tough comp for cough, cold in Q4 that we should be conscious on that might slow your volume growth rates in the generics business, in the Q4? Thank you.

Richard Saynor
CEO, Sandoz

Colin, do you want to take the first two, and I'll take the cough and cold?

Colin Bond
CFO, Sandoz

Absolutely. Graham, thanks for the question. But we don't break down North America into the individual countries, and what we've said in the press release is that, you know, we're confident of North America stabilizing ahead of the biosimilar launches and ramp up that are forthcoming. T hen on your question on FX, on a year to date, nine-month basis versus the prior year, there's about a 1% impact on the top line, because the euro and the dollar, well, the euro accounts for 40% of our revenues, has been pretty stable so far. Now, the euro has obviously increased in value over the last weeks, which will tend then to give a positive effect in Q4.

But that's somewhat offset by the fact that currencies like the Egyptian pound and the yen, in which we're long, actually will have an offsetting negative impact. So broadly, you know, as I said, nine months year to date, a relatively small impact, or approximately 1%. Y ou know, let's see, because we actually convert our sales on a month-by-month basis at the prevailing average exchange rates in the dollar s o I can't, obviously can't predict what is in store for the Q4.

Richard Saynor
CEO, Sandoz

Then on your question on cough and cold, I mean, clearly the season's a little late this year. I mean, clearly, we've had a very strong and warm autumn. I guess there were a couple of dynamics. I mean, last year, demand was way ahead of ability to supply, not just from ourselves, from a number of competitors. As we go into this year, now, clearly, we've, our supply position is stronger, so I'm confident in our ability to do that a nd certainly our demand at this point, particularly from the pharmacy chains and wholesalers, particularly things like anti-infectives, is very, very strong. Ultimately, how strong or late the final flu season is, it's probably a little bit too early to see.

But certainly from the demand that we're seeing, I'm confident that the comps should be reasonable compared to this year versus last.

Graham Parry
Senior European Pharmaceuticals/Healthcare Equity Analyst, Bank of America

Got it. Okay, actually, can I just throw one follow-up in there as well, Saynor?

Richard Saynor
CEO, Sandoz

Yeah, sure.

Graham Parry
Senior European Pharmaceuticals/Healthcare Equity Analyst, Bank of America

Just the price erosion also seems to be less, actually through this year than you were seeing, historically. Just wondering if that helps with EBITDA margins and, potentially getting you more towards the top end of your guidance range for the year.

Richard Saynor
CEO, Sandoz

Certainly doesn't do any harm, for sure. I mean, I think, I think we'd said, I think normally we've always guided or assumed in our planning assumptions and also going forward about a 5% price erosion. This year, we've seen about a net 3% price erosion. Clearly strong inflationary pressures at the beginning of the year, things like energy and labor and, and input costs. What's encouraging is we're seeing those pretty much washing out, towards the end of the year s o clearly, I think it's certainly going to help in terms of the margin mix as we go forward into this year, into next a nd certainly, you know, it's certainly not harming the top line, by a couple of points.

Operator

May I have your attention, please? May I have your attention, please? This is your final reminder.

As a reminder, if you would like to ask a question, please use the Raise Hand feature. Alternatively, if you dialed in, please press star nine to raise hand. Once you've been invited to ask your question, please unmute and ask your question. Our next question is from Balaji Prasad at Barclays. Please unmute yourself and ask-

Balaji Prasad
Assistant VP, Barclays

Hi, good afternoon. Can you hear me?

Richard Saynor
CEO, Sandoz

Yeah.

Balaji Prasad
Assistant VP, Barclays

Good. Great. Sorry.

Richard Saynor
CEO, Sandoz

Perfectly.

Balaji Prasad
Assistant VP, Barclays

Yeah, a couple of questions from me. Thank you for the, firstly, my apologies for the background noise. There's a fire alarm going on right now.

Richard Saynor
CEO, Sandoz

Please stay safe.

Balaji Prasad
Assistant VP, Barclays

Sorry about that. Firstly, I'd love to get your thoughts around the FDA seeking to eliminate interchangeability or at least de-emphasize that. How does that impact your developmental plans for future biosimilars, and also the current go-to-market strategy? Second question, probably following up on the previous one, about the improving pricing trends, where you called out continued stabilization. Can you comment more on the sustainability of the factors which are driving this trend, especially going into the next one or two years? Thank you.

Richard Saynor
CEO, Sandoz

Okay. Kinda thank you. I hope you're okay with the fire alarm. The FDA interchangeability, I mean, honestly, I think from a personal point of view, I think the designation caused more confusion than it actually, than it helped. If you think about biosimilars in Europe, they're automatically effectively designated interchangeable once they're given an approval a nd I think the fact that the US or the other FDA authorities created a position where one product was interchangeable specifically to one other, actually causes more confusion than not. Honestly, I do not see it as a barrier to entry. Clearly, at the moment, currently, we don't actually have interchangeability designation on our ADO in the US, and yet we have more lives covered than anybody else.

So I think from a real-world point of view, we have the data and the support to support patients and prescribers to use the product. I think that's really how I see it going forward. It doesn't change our strategy, it doesn't change our thinking. A gain, I go back to some of the comments that I made at the CMD. You know, ultimately, we define our portfolio very much with a European lens in mind, and so that the U.S., the incremental cost then to file in the U.S. actually is very minimal s o we see the U.S. becomes much more of an opportunity built on a solid foundation of our European business a nd that's really, really how I see it.

I think the current position actually just brings the U.S. much more in line with certainly the European regulators, and in terms of thinking, of terms of how biosimilars are adopted and used. In terms of pricing trends, I mean, clearly that's the way I like it in terms of the movement, but, as I said before, I don't really see, y ou know, hope isn't a strategy in terms of this trend continues. I'm certainly encouraged. I mean, I've met with probably eight or nine ministers of health and prime ministers this year having this conversation, and clearly, as an industry, we're very much seen as part of the solution, not part of the problem. I think the antibiotics business particularly gives us access to government in terms of having realistic conversations.

You know, it still frustrates me that we sell a pack of antibiotics more cheaply than a pack of M&M's, and yet, ultimately, we need to invest and make these products sustainable for, you know, generations ahead s o I think we're having those conversations. That said, we've still assumed about a 5% price erosion in our forward plans. I think that's prudent. But clearly, we're encouraged that we're now finding mechanisms to work with government, either shaping tenders, finding investment into manufacturing technologies, getting rewarded for holding inventory. There isn't one solution to this, but certainly I'm encouraged by the conversations that we're having.

Balaji Prasad
Assistant VP, Barclays

Great. If we could just add a follow-up. In your slide number 11, you spoke about the biosimilars market growing, expecting to grow from $23 billion-$122 billion a nd I presume that you're speaking about the global biosimilars market in total here?

Richard Saynor
CEO, Sandoz

Correct. Yeah, and also, what, I guess, what's interesting about it—I mean, because, again, the trouble is you're getting a, I guess, a number of figures. Clearly, you're looking at the gross figure from IQVIA, which doesn't really. For us, actually, biosimilars, it goes back to the point, I think, Colin made, that the ADA growth is in mid-teens in Europe, you know, three years since we last launched this product, because we're treating more patients much sooner in the life cycle of their disease a nd so that headline figure that you see really doesn't do that opportunity justice. If you think about a drug like denosumab and think about really the indication for osteoporosis, you know, the bisphosphonates as a class of drug are quite horrible. But patients just traditionally have never been given access to drugs like Prolia, particularly in Europe.

So the opportunity to bring that in at a very different price point and massively expand the patient pool, is really, really exciting and attractive. So, you know, it, it's an indication of the opportunity, but I think it only really shows part of that story.

Balaji Prasad
Assistant VP, Barclays

Sure. Thank you.

Operator

Our next question is from Eduard Riva at Zürcher Kantonalbank. Please unmute yourself and ask your question.

Eduard Riva
Analyst, Zürcher Kantonalbank

Thank you very much. Eduard Riva from the ZKB. My question would be regarding the price erosion also, and the fact that it's, I would say, on the bright side of your guidance of a negative mid-single digit. Could you elaborate a bit and tell us where does it come from, which category? Is it more from the generic side? Is it more from the biosimilar side? C ould you explain to us what was so good over the first nine months? Thank you.

Richard Saynor
CEO, Sandoz

I think a mixture of things. I mean, I think it's broad-based. It's not in one particular area. I think clearly in a number of markets you saw an evolution s o if you look at the U.S. during COVID, the FDA inspected next to no sites s o service levels were probably at an all-time high, and as a consequence of that, there was significant price pressure, particularly given the strength of supply levels to wholesalers and intermediates. Post-COVID, clearly, healthcare systems struggled to come back to the system. We saw significant out-of-stocks in therapy areas like anti-infectives. The FDA then started inspecting sites, and closing down a number of sites, particularly in the Asian markets a nd that then has sort of weird knock-on effects that, you know, currently oncology meds are difficult to access in the U.S.

I think some of that instability brought the attention of the insecure nature of the supply chain to governments, given the patient, you know, frustration, quite rightly, that they couldn't access these medicines a nd then really an open dialogue. You know, I've met with the head of the FDA. I think he summarized it quite nicely. You know, the problem in the U.S. healthcare market is the originators are too expensive and generics are too cheap a nd so I think based on that framework, we've been able to have conversations with payers and governments to say, "Okay, how do we make this industry more sustainable?" You know, we're treating in Europe, something like 80% of all drug usage is coming from the generics and biosimilar industry on aggregate about 20% of the cost.

I think clearly we're finding mechanisms. As I said, there isn't one solution in one market. You know, in somewhere like Switzerland, we get compensated to hold inventory. In Austria, the government are helping us invest in improved technologies to improve our cost of goods. You know, in Germany, we're looking at how we shape tenders to support European supply or European supported companies s o it tends to be broad-based, but certainly I think we're in a strong position, particularly given the size of our business in Europe and in the U.S., to have those conversations. Clearly, I'm keen that we continue them, and look at how we can support governments.

It's interesting, I mean, in drugs like adalimumab, we're starting to have conversations with payers to look at, okay, how can we support whole markets, potentially offer this at a ceiling price and look at supporting whole markets? I think it's allowing us to have a very different kind of conversation with payers and governments.

Eduard Riva
Analyst, Zürcher Kantonalbank

Thank you. Thank you very much. Just what, what would be then needed? Because the way I, I hear you, it seems that you would be able to repeat this conversation with payers. What would be needed for you to change this guidance of negative mid-single to, let's say, low negative single digit?

Richard Saynor
CEO, Sandoz

In terms of price erosion? Look, I think we've historically, always. I mean, at the end of the day, you know, we're selling products that price is a significant component factor of it, being purchased. It's very hard to change pricing decisions, but basically, ultimately, these have to be competitive markets. I think there's different mechanisms by which we can support the industry, and I've given you a few examples, and clearly, that's ongoing. Also, I think we're about to enter an unprecedented period where we're launching assets into a space that drives significant financial burden to healthcare payers, not just in Europe, but also in the U.S. I mean, adalimumab is what? A $20 billion asset. There's a significant opportunity to save a large amount of money for patients and payers and treat more, more patients along the way.

So you know, our interests are all aligned. It's just ultimately having those conversations and working through them. But, much as I'd like a simple solution, I don't think it is. It's about having, you know, being responsible, having scale, and working clearly in partnership with, in the U.S., it's with the PBMs and the insurers. In Europe, it's frequently governments, and different framework providers.

Eduard Riva
Analyst, Zürcher Kantonalbank

Thank you very much.

Operator

This concludes today's call. Thank you, everyone, for joining. This session has now ended.

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