Welcome, everyone, and congratulations for making it to this session on day four. It has been a bit of a marathon, and delighted to be here with Sandoz CEO. Welcome. Very, very good to see you.
Thank you.
The format's going to be a fireside chat, so we'll get straight into it in the essence of time. Richard, why don't we start off GLP-1s, as you kind of mentioned. You were one of the first to file in Canada. How do you see the competitive dynamic progressing, given your conservative expansion strategy?
No idea. I mean, I joke as I decide. I mean, I think, look, it's a super interesting market, a super interesting space. I think everyone's asking the wrong questions, but we'll talk about that in a second. Look, I can't see this market really starting to develop to the middle part of next year, but we'll see. I could be wrong. We're still waiting to see approvals come through. They'll come through. Bear in mind, we're focused very much on the diabetes indication for Canadian-only patients. I need to be very careful. I have no desire to get sued or being in court for driving. That means both what I say and what we do mean the same thing to what we would forecast against and the size of the opportunity. A very modest expectation.
That's first and foremost, and very conservative in terms of timing. I think the question then in the mid to long term you should be asking is, what is the available capacity? It's not the market. It's not anything else. It's how much can you make? A million pens is 80,000 patients. It's nothing. And then how elastic is this market? If you look at the U.K., one in 20 adults in the U.K. is taking a GLP-1 at GBP 400 a month. How many adults in the U.K. would take it if it was GBP 50 a month? Your guess is as good as mine. I think over time, those are the dynamic. It's a cold chain product. It takes up space in a pharmacy fridge and a warehouse and a wholesaler's fridge.
There are a lot of things at play that are not just how big is the market, because honestly, I've got no idea how to think about this as a market. At this point, it's not in our guidance. I've not given a target to the markets. We will see this as an opportunity. Clearly, we will build on that opportunity. It's interesting. I see it as a really exciting opportunity, but it is not the core focus of our company.
Thank you. No, I agree. I think we're all sort of trying to answer the same question to some extent. Maybe if I can try and ask it a different way. When you think about the different dynamics of the official manufacturers versus the compounders that have imported massive quantities of product into the US, how do you see, you talked about capacity constraints, but how do you see that kind of panning out on a global basis?
I still think, I mean, again, imagine a market like Brazil, all out of pocket, mainly cosmetic. That is still $300-$400 a month. Imagine if it was $30 a month, how many patients in Brazil? I think it is just going to naturally expand. Same in Turkey, same in a lot of Saudi, a lot of those markets. I think the patient demand on the price point. Actually, the positive is I think in the short to midterm, pricing will be higher because there will still be a constraint on demand at a lower, more accessible price point versus the originators. I think the compounders are probably going to be exposed in the US, but we will see.
Okay. You're right. It's not the main focus of the company. Obviously, biosimilars you've done a lot, so let's spend a lot of time on that because that's certainly where we get a lot of investor questions. Maybe start off with a strategic question. Obviously, we've had the Just – Evotec Biologics kind of acquisition. This helps diversify your manufacturing strategy. It helps kind of outline how that deal will be accretive and contribute to the wider group and I guess the steps from here on the integration.
Next step, hopefully the French regulators approve it and we close the deal, finalize the public announcement. That is hopefully fairly soon. Next year we integrate into the business. I think we've already guided there will be some one-off costs next year associated with that that we're effectively preponing from later on. Overall, over a longer period, it's net neutral. Why did we do the deal? Really, I guess three answers. First of all, it's control. We have much more experience taking a site from a clinical development through to a regulator becoming a manufacturing site. The site in Toulouse was built for us. Now bringing it in-house means we've got far more control and more confidence about managing with the regulators and getting it through. Second, profit. Clearly, by owning the asset beyond a certain number of projects, then we pay no royalties.
It becomes much more accretive to our overall P&L. Lastly, flexibility, both flexibility in-house, but also then to potentially further put J-PODs into Slovenia or other locations. It becomes a very attractive technology over the medium and long term as well.
You talk about control, but can you help us also think about the capital investment that's required in integration to the rest of your sites? I guess, is it incorporated in one year? To help us sort of.
I mean, the capital, I mean, a lot of the costs were already in the cost of how we'd structured the deal anyway. I do not see it necessarily significantly greater in terms of the initial CapEx. Actually, the CapEx there potentially means it avoids CapEx in other places. We think it is probably net neutral. As I said, there are some one-off costs next year as we integrate certain things like technology and so forth. Beyond that, clearly it becomes more accretive to the businesses as we launch. I mean, we do not start seeing the products coming out of that site till the other side of 2030. This is more of a medium play.
Thank you. I guess in this context, you can comment the potential $300 million in milestones in terms of that are going to be paid. When should we think that?
They were already embedded on that anyway. There are extra milestones and royalties linked to that pipeline. In a sense, now we brought those in-house. You have more visibility of them, but it does not change the shape of the P&L.
Okay. You had a lot of news flow this year in biosimilars, which has been great, and the market sort of clearly looked at that. What catalysts can you point us towards in 2026? Everyone's looking forward. We'll talk about some of the successes you've had, but just specifically on 2026, what events can we look towards?
I guess we've launched six biologics this year. Most of that will flow into growth in 2026 and beyond. I am clearly super excited about that. We'll launch Aflibercept in the US later next year. I think we've got a nice momentum of launches as well as leveraging what we have. I think the story for us then is more, okay, I think we're really at this exciting transition point. There's still something like $300 billion of product coming off patent in the next 10 years. There's more product coming off patent than the history of the industry. Yet, bizarrely, the competitive intensity is going down. There are fewer and fewer people developing biosimilars for all sorts of reasons. I get two questions. Clearly, with the regulatory changes, the removal of phase three, I see that as a massive opportunity.
For us, it's probably the biggest event since Hatch-Waxman. The ability to develop a biosimilar for maybe around, say, $80 million in five years, roughly half what it's currently costing, means that we can get, certainly for the same amount of spending, we can get twice as many assets. I think we can go even further. The next question, doesn't that mean you're going to get waves of competition? I don't buy that for several reasons. This is still $80 million. It's an expensive hobby. You still need manufacturing capability. The bit that everybody forgets is you still need a commercial front end. A lot of companies struggle, particularly the one and two product companies.
They think they can get into the US, maybe, maybe not, but then they fail miserably the rest of the world because you need a sales force, a medical organization. In Europe, that's 40 companies. Having the combination of the two, clearly the capital over a four or five year period. That excludes most PE backed biologics companies. I think we have scale. We're already a leader. We have a commercial footprint. We have the best pipeline already in the industry. Let's be honest, we're also already used to competition. I mean, there's 12 Denosumab in the US and we're the leading player in the US. It's not like we don't know how to compete. We're vertically integrated. We have transformative technologies, and we are the partner of choice to the majority of the industry.
I think in a sense, this is a space for us to execute into.
Let me sort of ask that. I mean, needing a commercial front, absolutely. I guess we saw a deal announced by you not so long ago in terms of having a partnership. How are those kind of early sort of BD discussions evolving if there are companies out there that are perhaps looking to develop products in this potential new environment where you're potentially able to step in from a commercial side to help them?
I think it's a real, I mean, we're wrapped with that. We have become a partner of choice to a lot of the industry. That has two bangs. I mean, clearly, if we identify products that know what we can't partner with, then we're better developing it in-house. So we get more portfolio, which is fantastic. We have a depth. I think then think about it in terms of three terms. Clearly, in-house, relatively straightforward, straight BD. The Samsung deal was a classic in-licensing deal, not particularly margin accretive, but we had no development costs and no milestones. You have more strategic partnerships. I think there's opportunity there where maybe you look at a co-development of, say, half a dozen assets. We do three, they do three, and then we become a commercial platform.
I think there's a number of ways that we can structure deals. Then it's about size of asset, geography, cash, and timing. A mixture of that. What I need is product. We have this amazing commercial organization. The teams do a phenomenal job. We just need more and more product.
Let me ask you about product selection then, because I guess the company's always been clear that they're a European business with a US business, right? I guess when you think about developing assets, and I guess you can't develop them all at the same time, you need to prioritize. If there's an asset which potentially could be launched earlier in the US before Europe, would that kind of impact the selection criteria? We've obviously had more experience in Europe and then looking to leverage that IP in the US.
It doesn't normally happen that way. Normally you have to go through court and then you end up dragging that out. I mean, you've got to look at it on a case by case. In a sense, it's not a rule. It's a philosophy. Clearly, we would normally develop products for Europe because I know every product we've ever filed, we've launched. Every product we've launched, we're number one or number two. We know we'll get our money back. Then it's clearly file and see the US as an opportunity. The problem I have with the US is you look at a drug like Enbrel. Some judge somewhere decided that a 30-year patent life is somehow acceptable in the US. Now, if that was my business model, I'd have gone bankrupt.
You can do all of this work and then still have some idiot judge at the end of the day say you can't launch. I think the certainty that Europe brings and then the opportunity that allows you to bring assets to the US is much more attractive. I would say preference for Europe. Clearly, we will leverage the US, but it's a subtle but important difference. I also generally have a preference towards immunology over oncology. Again, directionally, it's not a rule. Why? Most oncology assets are tenders. Whereas immunology assets, patients can be on for 10 to 20 years. You can expand access and it has a very different dynamic. Clearly, we'll do both. As you look at those two things, it's not just straight the numbers and it's not just Europe, US.
I think last time I asked you, there were 28 products in the pipeline. I do not know if that is still the right number. I guess when we think about the lean of that, what you just described, is that how you would kind of highlight the distinction?
I mean, we've just launched one more and so it's always going up and down. I'd like that 28 to go up significantly over the next few years.
Yeah. Okay. That's clear. A couple of product questions on a few products you've got, I guess. Ustekinumab, how has the uptake progressed and how material is the opportunity given the competition?
It's gone well. I mean, it's an in-licensed product in Europe now. We've just launched the auto injector. We're the only company with an auto injector. Pleased with the performance in the US. We have our own one-own label product. And then through another partnership, we have another own label where we get a royalty stream. I think at this point, it's been a success for it. Certainly in Europe, I think we're the largest player by a significant margin. It gives confidence to other partners and other future deals that we can execute and compete in that space.
Mark was obviously focused on adalimumab. I mean, can you give us an indication of how the Cordavis penetration is progressing since the loss of IQVIA data makes it slightly harder for us?
Yeah, no, and it's a bit of a finger in the air. I mean, if you look at the latecent, we've got I think about between 60% and 70% of the available biosimilar market that has converted, which is about 35%-40% of the total market.
Okay. That's helpful. I guess there's probably an expected renegotiation next year. I guess what scenario is required for that to not be accretive for you?
You have got to think there is not much more volume upside with the Cordavis deal because they converted something like 95% patient lives. In a sense, you are never going to be accretive from day one because you have captured the bulk of the volume. It is now a price negotiation on a relatively fixed volume. The accretion is then how you expand the rest of the market over time. Can you switch existing patients, acquire new patients? This is still a very large market and we are the largest player in that market. That is really where the accretion comes from.
Understood. And then Denosumab, how have you seen the relative progression in the oncology and osteoporosis indications?
Really well. Actually, it's gone extremely well. Probably seen a little bit more in the osteoporosis indication than we perhaps initially anticipated early on. Again, we were really, I think it was really well executed by the team. We were the only company with a Q code. Without a Q code, you can't get reimbursed. You can have competition, but you can't get paid for it. That meant we had pretty much a two- to three-month window versus most of our competition. We have captured quite a lot of share, a lot of the payers, and a lot of the former. I think that's given a really strong business momentum forward towards the end of this year and a very nice platform to grow into next year.
Rapid fire, we're getting through a lot of these products. Denosumab, given the headwinds in Kimberley, what measures are taken to ensure this scenario doesn't occur in other brands? And I guess what's your expectations?
Part of it's the dynamic of the market. If you lose control of your WAC and your ASP then and the timing of the reconciliation, you can end up in a situation where you end up paying to sell your own product, which is the problem. Part of it then is do you have a high WAC or a low WAC selling price? I think we've learned a lot of lessons and clearly we will reintroduce similarly next year into the market and as well launch our Aflibercept to the market as well in combination. I think we're well positioned, but we've learned a lot.
Great. I guess finally, we saw Tyruko was launched this week. That's great. Very early stages, obviously, but what I guess are you seeing, given you're the only competitor to understand, I guess what can you tell us of the preparations on any stocking?
I think we're three days in, so clearly going well. I mean, look, the feedback from our strategy is acquiring new patients rather than converting the market, which is slightly different maybe to say some of the Europeans. This will be a build rather than a bang, but it's still a highly attractive market. We're really pleased that we're offering patients an alternative access to a drug. I think we have a great test now to work with clinicians with a good data package. Certainly the initial feedback three days in has been very positive. Probably ask me again in a few months' time.
Absolutely. Switching gears a little bit, just thinking about strategy in terms of China. We hear so many different things based on the positives and the negatives in terms of what that potentially brings in terms of how the local players are looking to expand outside traditional markets. If China is potentially more a partner than a competitor, given the infrastructure that you maybe have, if they do not want to build outside the US, where do you see you have the greatest potential to work with companies in China?
I think there's two or three companies that we're looking at and have significant potential to strengthen and broaden our pipeline. When I see China as an opportunity from our point of view, we exited our commercial business in China. I don't see it as a market that we have necessarily a right to win and enter as a European biosimilar player. I do think as the leading player and the largest global player, we are the partner of choice of a number of Chinese companies who potentially we can offer a very attractive platform to.
Thank you.
We will tell you more as we go through.
Thank you. Just a quick question on the generics business. I guess the company's consistently said it doesn't believe in complex generics. I guess other players have said they see that's a way to add value, just because in the industry trying to get a price. So why is it the company doesn't?
I think it's not that I believe in complex generics. I mean, that's a different point. I think what you're referring to is value-added medicines. I've always described those as a solution to a problem no one wants to pay for. In the once-a-day treatment or whatever, they sound great, but they're the worst space you can be. I'm a generics drug company. The best we sell on access and price. The worst thing you want to try and be is an innovator, a generics company trying to sell like an innovator company. Your P&L doesn't support it. Your investment cycles don't work. If you don't have a whole portfolio in that space, the economics don't work. It's the quickest way to kill a generics company is trying to become an innovator company.
The quickest way to become an innovator company is behave like a generics company. I think it's about giving clarity. We're sitting here with a record number of LOEs. I'm not short of opportunities. It's more about how do we find the capital and execution to grab as much of that, drive more access, and grow our business.
There's an interesting report out talking about stable antibiotic supply. I guess interesting in the nine-month release, you even called out thinking about in Europe and penicillins, etc. Just want to give us some context around that, just given the role you play in the global supply chain and penicillins.
Yeah, look, I mean, Sandoz or penicillin V has saved more lives than any drug in the history of mankind. So it's a super, it's easy, simple operations to major operations. This was a rescue therapy when it was injectable. That got invented in Kundl 80 years ago. Today we sell it more cheaply than a packet of M&Ms. Yet the U.S. government today buys its drug substance from China. There is only one manufacturer left in the Western world, and that's in Kundl. European governments have a very, Western governments have a very stark choice. They either work with us to support and make this business sustainable, or one day they will lose it. No one's ever going to build another beta-lactam facility. $3 billion and no return, it's not a good investment.
I think the conversation, I mean, I'm in the U.K. government tomorrow. I think they get it. I think the conversation that we need to have is how do we make sure this is sustainable for future generations. I want this business to be part of the company 80 years from now. I'm sorry, we can't be selling a packet of for GBP 1.50. It's offensive. How do we find mechanisms, whether it's through tender shaping, strategic stockpiling, whatever. There are all sorts of mechanisms, but I think it's highlighting the sensitivity. I want to deliberately put it in the earnings because clearly we saw where Chinese API suppliers whose energy is heavily subsidized, their ESG criteria are very different, are driving down a price point that means it's unsustainable. I have a responsibility both to our shareholders, but also to patients and to government.
At the time of the spin, the company gave a midterm guidance out to 2028, which is commendable just given how many generics companies often can't get that level of visibility. A couple of years in now, there's been a number of acquisitions which have sort of been made. You obviously have tweaked the margin as you went kind of through this year. When we think about out to the midterm, how much of that is within your control versus sort of other dynamics at play? We get a lot of questions from investors sort of thinking where we are along that band and some of the put and takes to get to either end.
I mean, if I was with my boss, my Chairman yesterday, and we were talking about my scorecard, I think all of the things that we said at the capital market days we've done. Margin expansion, sales growth, the pipeline that we said we delivered, the free cash, we've executed on all of those things. Actually yesterday, Natalizumab was the last commitment in terms of pipeline launches that we made in London and New York two and a half years ago. We're already ahead of a number of those commitments. I think the margin journey is tracking extremely nicely. We're ahead on the biologics as a percentage of our sales. It was all about building credibility. I think when we started as a new company, nobody knew of me, nobody knew the management team. This was an unloved sector.
I think somebody described it as the best house on a bad street. I think we've shifted that sentiment. I think we're well on our way to continue to do that guidance. I think the conversation we're now having is, okay, at what point and how do we refresh that guidance and give a different horizon view on what's appropriate to you as a community and also what's right for us as a business.
What is the optimal timeframe to do something like that? Because clearly the market has spoken in terms of how the shares have done since the overall spin. You have had a lot of momentum coming through. What would it take to have you get more confidence to update that timeframe?
I don't think it's about confidence. I think it's about the environment. I think as we started the conversation today, we see this, I think we're at a tipping point. We can continue to evolve. I think very clear, huge opportunity, and I'm very pleased with that. How do we grab a significant larger proportion of the available opportunities that we see in front of us? I think that's then how do we have the conversation around those things? I think that's very much the debate we're having at the moment.
I'll certainly say from the investor conversations I've had, there's more comfort with the midterm on the P&L, on the cash flow. I guess the $1.5 billion number, which you're giving, can you give us some of the building blocks to get there in terms of where we are today? Because that's probably where there's the biggest.
In terms of free cash.
Yeah, the $1.5 billion.
Yeah, I mean, we always said, look, upfront, we became, we were a division and now we're a standalone company. We had to build new factories. Okay, tick. We're pretty much most of the CapEx is now spent. We had to spend a lot of money building our IT platforms. We're now out of the TSA and finally running those. Tick. We always said 2024, 2025 would be the main spend. Clearly, you need to start seeing, quite rightly, the free cash starting to build back up as we come into 2026, 2027. That's always been in line with our guidance.
The company's done a number of acquisitions. What is the current thought process around M&A and what sort of things do we do?
It's not important. I mean, M&A, if you think about where we did a couple of M&As, M&A in the US we did to give us exposure to the ophthalmology market and a capability in that space. I think it was more very strategic for the US, but not particularly material in terms of size. I would say exactly the same with Just –Evotec Biologics. It's absolutely bang on strategy. It gives us control over a key technology. We're sitting here. We don't need to do M&A to grow our business. We have more than enough opportunities to focus and leverage. We're at scale. I'm not even sure what's out there that would be super attractive. I think what I'm more focused on is strengthening the balance sheet, keeping on doing what we're doing. We see the right opportunities, but I think we'd have to make complete strategic sense.
When you think about delivering kind of over the midterm, it's obviously all about execution on the pipeline and some of the licenses that you've been given. What sort of that you've signed executing on procurement, etc. Where would you say the blind spots are for three to five? What sort of work?
I think we don't talk about, I mean, obviously at the moment we take most of our supply from Novartis and other suppliers. As Slovenia comes on stream, Just –Evotec Biologics, again, that's another step improvement in our cost of goods and our operating efficiency. I think there's that. Also the bit, we have nice momentum and growth in the business. The key is controlling our cost base, our headcount base on a business and allowing the business to grow far more quickly than our cost base. If we do, then we get leverage. We've now consistently grown 16 straight quarters. Now we've restructured the company. We've taken a significant headcount out of the business.
I'm putting a lot of pressure to keep that as tight as possible and leverage technology, leveraging our GCCs, the hubs we have in different locations to maintain a tight cost base because we're a generic drug company. We're not a pharma company.
Yeah. Maybe just the last, finally, in the essence of time, I guess maybe you had a lot of investor meetings today over the past kind of weeks. Is there any part which you feel is perhaps either kind of misunderstood as you kind of come into next year? What would you highlight to people in the audience looking for ideas?
No, I think people, I think we're starting to get a lot of positive feedback. People like our story. I think the key point is very much European focused with the US opportunity. I think the exciting debate around the future pipeline, naturally a question, does that mean more competition? I'm much more glasshouse full. Then it's an execution story. I think already we've executed well over the last two and a half years. It's up to me and the team to keep doing it.
Excellent. That wraps up time. Richard Saynor from Sandoz, thanks very much.
Thank you.