Ipsen S.A. (EPA:IPN)
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May 4, 2026, 1:05 PM CET
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Deutsch Bank Depositary Receipts Virtual Investor Conference

Nov 8, 2023

Zafar Aziz
Director, Deutsche Bank

Hello, and welcome to the Deutsche Bank Depositary Receipts Virtual Investor Conference, DBVIC. My name is Zafar Aziz from the Deutsche Bank team. I'm pleased to announce that our next presentation will be conducted by Ipsen from France. Before I introduce our speaker, a few points to note. Please submit your questions in the Questions box below the slide. Once the Q&A session has ended, don't log out. You'll automatically be transferred to the Ipsen booth, where you can continue to ask questions via chat and access shareholder materials. On a final note, all today's presentations are recorded and can be accessed via the Deutsche Bank website, adr.db.com. At this point, I'm very pleased to welcome Craig Marks, Vice President, Investor Relations of Ipsen, which trades on the Euronext Paris under the symbol IPN, and in the U.S. on the OTC Markets as IPSEY. Over to you, Craig.

Craig Marks
VP of Investor Relations, Ipsen

Okay. Thanks, Zaf, and hello, everyone. You heard Zaf there talk about Ipsen of France, but you can probably tell my accent isn't so French. I'm calling and dialing in from a not-so-sunny U.K. It's a fairly typical day in November in the U.K. today. I plan to spend around 10-15 minutes or so taking you through the presentation. I've got around a dozen or so slides just to guide you through Ipsen's journey and Ipsen's transformation as a business. I joined Ipsen nearly three years ago, and I've seen the business hugely transform in that time, and it become I think an attractive proposition for the market. I plan to take as many questions as I can at the end.

Feel free to submit questions, and I'll take those as they come. This is our safe harbor statement. All growth rates you'll hear today will be at constant exchange rates, unless specified otherwise. I'll kick off with the investment case of Ipsen. Ipsen, for those of you not familiar, is a French biopharmaceutical company. When I say French, it's based in Paris, but it used to be effectively a French company. Now it's a global business with a head office in Paris, and that's quite different to how it used to be. The fastest region of growth for us right now, representing around a third of our sales at the moment, is the U.S., and we see that as the real engine of growth going forward.

What we've done over the last couple of years is really narrowed down our focus onto specialty care. We did have a consumer business, a consumer healthcare business that we divested over 12 months ago. So now we have a business that purely focuses on three therapy areas: oncology, neuroscience, and rare disease. The second element of our global footprint is our global presence. You know, we're in over 100 countries right now, around 35, and over 30 in direct affiliates with offices in various countries, most recently opening up in places like Dubai, Colombia, and Saudi Arabia. So we have a nice global presence to leverage our medicines and our launches. The third element is our pipeline.

So our pipeline is based off external innovation, so we don't really have that many people in lab coats standing in laboratories. We tend to take what biotechs create and we bring those into our pipeline through the external innovation strategy and model. And we've been at a rate of knots refilling our pipeline, replenishing our pipeline. That has led to a number of potential launches over the next two years or so. So it's quite an exciting time at Ipsen that we were a reasonably quiet news flow company up until around 12 to 18 months ago, and we've been seeing some real productivity success coming through in the pipeline, and that is set to continue.

So the fourth element of the investment case is that external innovation strategy, where, over the last two years or so, we've brought in over 20 programs into the pipeline and portfolio. So we now have far more shots on goal as a business, much more diversified, than we used to be. And for those of you familiar or, slightly familiar with Ipsen from before, we used to be very dependent on one medicine, that I'll talk about in a moment, that was generating nearly half our sales and around half our profits. That medicine now represents around a third of our sales and falling, and we now have multiple shots on goals, on goal with a number of medicines across a range of indications. And then the final element to the investment case is our balance sheet.

We have a very strong balance sheet, so we use for our capital allocation, priority number one, which is to fuel the external innovation strategy and to do more deals to replenish the pipeline and portfolio. We run with actually pretty little debt. We had minimal net debt at the half year, despite over the last couple of years, undertaking major transactions, including two major acquisitions. And we run a very strong level of cash generation, so over EUR 800 million of free cash flow last year. So those are the five compelling elements of the investment case. So as I say, you know, our vision is really to be that leading global player in mid-sized biopharma.

We realize we're not gonna be taking on Pfizer or Merck anytime soon, so we realize the size of the business. But we're getting to a position where we're really driving our increased scale. We have operating leverage opportunities, especially in the US, as we introduce and launch more medicines into the US business. And we're focused on those transformative medicines across those three therapy areas. We were very, very weighted towards oncology, and you'll see over the next two years or so, a number of potential launches this year and going into the near-term period, across rare disease as well. And we also have a couple of really exciting shots on goal in neuroscience. So it's becoming a much more balanced and diversified company.

So where we are today is that, we have four medicines or what we bracket our growth platforms. So these are medicines that have either been around for a little while or are reasonably new, but are clearly, as you can see on the slide, delivering very strong growth. So as a combination, Dysport in neuroscience and Cabometyx, Decapeptyl, and Onivyde in oncology, continue to deliver strong growth for us when you combine them. And they're typically growing between 15%-25% in combination each quarter. Dysport, just to explain, is effectively our Botox. We're typically in markets, either number two or sometimes number one in those markets, across therapeutics and aesthetics in that cosmetic setting. And we commercialize in a large number of aesthetics markets with our partner, Galderma.

The Cabometyx, that is an oncology medicine used to treat renal cell carcinoma, a form of kidney cancer, that again, you can see is performing very, very well. Decapeptyl in prostate cancer is a more mature medicine, but again, continues to perform well, particularly over the long term in China. Clearly, there are a number of near-term headwinds in China, in terms of the economy, but overall, China is an attractive market for us with Decapeptyl. And then Onivyde, I can take you through later on, one of the significant opportunities we've got with a potential FDA approval in February that would significantly accelerate the potential of Onivyde. Now, Somatuline, you can see in the middle, that's been gradually declining now for some time.

This is used to treat what's called neuroendocrine tumors, a form of cancer, a fairly prevalent form of cancer, but kind of falls under the radar below the headlines of lung and breast and ovarian. But you can see that it now occupies around a third of our sales, from around half our sales that I mentioned earlier on. So that went and it lost its exclusivity in the U.S. in December 2021. So we've seen some competition come into the U.S. in that class. And also, around two and a half years ago, we saw a generic competition in Europe. So we've managed that client decline well. You've seen, on average, 10%-15% decline each quarter, year-on-year for Somatuline, and we continue to assume that will decline gradually.

One of the most exciting elements on the page are our new medicines. So we acquired Bylvay at the start of this year in rare liver disease, and that's performing very well for us so far. We closed that deal at the start of March. Tazverik was acquired last year when we acquired the company, Epizyme. And that's in follicular lymphoma, a form of blood cancer, that again, you know, we're excited about in terms of where it can go, in the future. And then Sohonos is a rare disease medicine used to treat what's called FOP, one of the rarest diseases in the world. A very, very debilitating, and terrible disease, called FOP, and that was approved by the FDA in August, and we're in the process of launching that across the U.S., right now.

So we see growth potential and opportunities right across new medicines and our growth platforms, which together represent around two-thirds of our sales versus Somatuline at one-third. So this is the shape of the business as we see it going forward. We think our growth platforms will continue to develop and continue to deliver good growth. Somatuline will decline gradually, and then the new, new medicines I talked about, plus further external innovation in the introduction of more medicines by in-licensing and other forms of agreement, that will come into the fold, come into the portfolio, and come into the pipeline, will accelerate that growth. So that's really the best way to think of our top line over the medium to long term.

So I was talking about that global footprint, and this is a really important slide because this shows that we have leverage opportunities, particularly in North America. So North America, you know, if you look at the U.S. specifically, we y ou know, this time last year, we broadly had three medicines in, in market. This time next year, we could have seven. And those medicines have the potential to deliver, you know, a very strong contribution to the group over the long term. The rest of the world is set to continue growing. I think probably where you'll see as a proportion of sales, the number falling on the page, may be Europe. So Europe, we have less.

So we don't have rights, for example, to Onivyde in Europe, and Onivyde is one of those strong potential opportunities for us. So as a proportion of sales, I'd suggest that over time, North America will exceed that 33%, and Europe may see that 40% decline. But a very strong global presence, and as I say, a global business with a head office in Paris, rather than being what we used to be perceived as, which is a French pharmaceutical company. So we recently delivered our Q3 year-to-date results for the first nine months of the year, again, posting strong numbers. So on the left-hand side, you can see the growth continuing. 7% growth in Q3, 6.5% itself, and then our growth platforms up by 16%.

As I was saying, you know, Dysport, Cabometyx, Decapeptyl, and Onivyde combined growing by 16%. And we're seeing nice contributions now from these new medicines, Bylvay in rare disease, Tazverik in oncology, and Sohonos in, in FOP in rare disease. We're making good progress with the pipeline on the right-hand side, with the approval of Sohonos in the U.S. We've seen some encouraging early data for a potential Cabometyx trial, an extension in prostate cancer. So we'll await further data on that before we'll know the full picture. But certainly, seeing the initial data so far, that was positive. With Bylvay, we had that approved in a second form of rare liver disease called Alagille syndrome, had that approved in June in the U.S.

We'll look to resubmit our file in the EU with a potential approval in Alagille syndrome in next year, at some stage next year, probably around the middle of next year, something like that. And then elafibranor, which is really the number one question from the buy side right now. This is an asset that we brought into the pipeline, and we partnered with a company called Genfit. That came into the pipeline around two years ago, and this is our opportunity in a form of rare disease called PBC. Now, we will present that full dataset of elafibranor from the phase III data. That will be presented next week at the AASLD Medical Congress in Boston.

We will have a Q&A call after the data is fully presented to answer the market's questions on the data itself. Then the final element of this page is really the guidance. So we've confirmed our guidance for the full year. Our sales growth being greater than 6.0% at constant exchange rates for the year, with a core operating margin and EBIT margin of more than 30%. So, you know, I think overall, you know, a strong performer. We continue to do well and manage over the last few years to manage that decline of Somatuline, which has faced the loss of exclusivity, and the rest of the business has been performing particularly strongly. Now, this is our latest pipeline.

I won't go into details here, but there's broadly kind of two key messages to this slide. Across our clinical development pipeline, you can see now that we are broadly, you know, nicely split between oncology, rare disease, and neuroscience. This was very blue two to three years ago, so we were very, again, very weighted, not just in sales, but also in terms of our pipeline towards oncology. We're seeing more rare disease on the page as we've undertaken many deals over the last few years, bringing in, as I say, more than 20 assets programs into the pipeline. But also we've got a number of, as I say, shots on goal where we'll see potential launches coming.

So, Bylvay, for example, in rare disease, we have the potential, coming up in the medium term in what's called biliary atresia, which we see broadly as a $400 million peak sales opportunity. So that's a third indication in rare disease. Also in rare disease, elafibranor, which I mentioned a moment ago, is being trialed both in phase II and phase III. PSC, which is primary sclerosing cholangitis in phase II, affects predominantly men, whereas PBC in phase III predominantly impacts women. And we see this as a significant opportunity. And next month, at our Capital Markets Day, we'll be giving our peak sales estimates for a number of these opportunities. So I think overall, you know, good opportunities across oncology, across rare disease.

I'd finally, on this page, like to draw your attention to our longer-acting neurotoxin in phase II, in green, at the bottom of the page. You know, we have Dysport right now across the aesthetic setting in cosmetics, but also in the therapeutic setting, performing very, very strongly this year, up by around 24% this year. But our longer-acting neurotoxin in development across both aesthetics and therapeutics has the potential to deliver, just as the name says, a longer-acting impact. So, you know, typically, a neurotoxin in this space may deliver you around 12-16 weeks worth of treatment impact.

The idea behind these trials in phase II and potentially then in phase III, it's in proof of concept right now, would be to deliver six and maybe up to nine months worth of impact, which would be game-changing. We are excited about that opportunity, although clearly it's still at an early stage and is a medium-term opportunity. Then finally, Dysport in green at the bottom on phase III is a new trial. There's actually two trials we've initiated for Dysport in migraine. Now, migraine is you know, a large market. It's dominated by one player right now, but we also realize there are a number of other entrants in that space, so we realize it's competitive. However, it's a significant market.

We do not have migraine on the Dysport label right now, so we see this as a material opportunity over the medium term. So really, to conclude, and I, I've kind of stolen this from our Q3 results. I mean, effectively, our sustained strategic success is delivering two things. One is the growth momentum. It's the, you know, our growth platforms, which occupy nearly two-thirds of our top line, continue to perform well, and we're seeing a nice increase in contribution from those three new medicines. On our pipeline, we've seen a number of milestone successes. For example, you know, the data we saw on Cabometyx and the approval of Sohonos both happened in August. And then finally, the multiple launches that are expected in the near term.

So we're really on track to continue delivering, both, you know, for patients, and, and certainly for the market, because the, because of the numbers that we continue to print. And then finally, I'd like to draw your attention to two things, in the diary. So I alluded to the fourteenth of November, which we would have our Q&A, webcast and call for investors and analysts, following the elafibranor data that we'll present next week in Boston. And then our Capital Markets Day, we are furiously writing slides for at the moment. So the seventh of December, there will webcast, but is in person in London, and invitations by, so attendance in person is by invitation, so let me know if you'd like to attend. And that's gonna be on the, on the seventh of December.

We will really set out the medium-term shape of Ipsen and the opportunities we've got to continue growing and transforming. So that was my presentation. I clearly went a little bit over, so I'm just gonna go to the questions. So bear with me, bear with me a second as I read those questions out. So the first one: What are the drivers of 25% growth in Dysport and Cabometyx, and do you expect this level of growth in 2024? I can't give guidance by medicine and for next year, but I think, you know, we have said over time, you know, we clearly don't expect Dysport to continue growing at such a high pace. It's been delivering exceptional growth. I think between 2020 and 2022, Dysport was up by over 50%.

Now, some of that was driven by the Zoom boom. People, you know, see themselves on Teams and Zoom and, and so on, and realizing they need to hide the self-view, and if they can't find that button, they tend to, you know, sometimes consider getting a shot of Botox or a shot of Dysport. So that's clearly been a short-term fillip to the market, but, you know, we're not gonna continue growing at such a high rate. But, you know, at our Capital Markets Day, we'll certainly give you more idea as to where we think Dysport can go. On Cabometyx, you know, Cabometyx, again, has been very strong for us in renal cell carcinoma within kidney cancer, which is where the predominant level of sales sits.

I can't, again, give you guidance on where that's gonna go, but at our last Capital Markets Day, on a risk-adjusted basis, we said EUR 700 million of peak sales, at least, for Cabometyx, and we're certainly on track for that right now. So, it's looking good for Cabometyx. It's looking good for Dysport. The second question: What are the expectations for M&A within the biopharma industry, and specifically the oncology space? So I think, you know, certainly for us, we continue to see opportunities. We turn down many, many opportunities, but I think it's fair to say, you know, we are. It's certainly Ipsen is now seen. It's really seen as a partner of choice, and I think there's probably a number of reasons for that.

One is that we still, you know, we have eight medicines in market. We'll potentially have a ninth next year with elafibranor, but we don't have 100, and therefore, we can, you know, give a new asset the focus it deserves. It can take the management time, it can take the resources of the business to really drive the potential of that asset. I think also a global footprint, as you can see, how many countries we're in, either directly or indirectly, and that expanding presence and our certainly our sales, marketing, and R&D bases around the world means that we can really drive the potential of those medicines hard. And I also think the quality of our executive management team, our senior team, I think is exceptional.

We continue to recruit better and replace with better, is how I feel, and I certainly think the quality we've got as a business is so strong that, again, we are very attractive when it comes to business development and M&A. So I think there'll continue to be opportunities, whether it's in oncology, whether it's in rare disease. I think probably neuroscience is, you know, you have to clearly be careful in neuroscience. You know, you have to be exactly clear on what you want. You know, our criteria for deals are still that we look for deals where an asset has potential peak sales of between EUR 300 million and EUR 800 million.

It has to be within one of the three are therapy areas, and really where we can drive a difference, where we can drive value. So we'll continue to screen. We have a number of people looking at opportunities all the time, and I'm sure across the industry, there'll continue to be opportunities, including in oncology. The next question: You noted static FX rates. Does the company disclose FX hedging coverage rates? So we've said for this year, we actually originally, before 2 6th October , our Q3 results, we said that FX would mean a headwind to our top line of 3%. We now think it's going to be 3.5%. So we don't disclose.

We certainly don't disclose our full contracts or our hedging contracts, and how much we hedge, but certainly, in terms of FX, it's getting a little bit more difficult. We clearly hedge, you know, a significant proportion of our exposure. But, you know, we do have a significant business, for example, in Russia, with our, for example, our therapeutics Dysport business. So clearly, there are challenges there. So, you know, we have been hit by FX this year. If you look at our Q3 results, you know, our share price is down on the day, principally because of FX, because the rest of the business, the underlying conditions, trading, and performance was unchanged.

The next question: What, what are the drivers behind the large jump in net investments over the year, over the last year? What's the normalized rate of investments? I think, you know, we, we've. I suggest if the, you know, it depends on what line are you looking at, but, you know, the most significant investment we've made this year was the acquisition of Albireo that we announced at JP Morgan in January and closed at the start of March. So that was a sizable transaction of over EUR 1 billion in consideration, in value, that we closed earlier this year. And then last year, we acquired Epizyme, again, another biotech that principally came with Tazverik in hematology.

So, you know, the investments we're making, you know, primarily over the last couple of years, have been represented by the acquisitions we've been making. Can you speak to the status of the Albireo integration? Is it on track and as expected? I mean, I can only speak anecdotally. Certainly, you know, we're very, very far through the integration process. But I have to say, the quality of people that have come across has been exceptional. A number of them are working with me at the moment on our Capital Markets Day, and I have to say that the quality right through that throughout that business has been, you know, for me, very, very strong. So I'm particularly pleased with the Albireo acquisition.

And also, you know, the principal asset that came across was Bylvay, which is in market, it's only recently been launched in one of the three rare liver disease indications that we're looking at. But certainly, it's performing very, very well. It continues to outpace analyst expectations each quarter. And we're seeing, you know, a nice launch, not only in the first indication, but also we launched in June in the second indication once we had FDA approval.

And that's working out quite nicely for us, although that's early days. So I think overall, Bylvay, for me, a big green tick, and the quality of the Albireo integration and the quality of my colleagues who've come across, again, a big green tick. I'm not seeing any more questions, so feel free to send any questions through. I'll just wait one moment just to see if there's any more. Okay, so it looks as though there are no more questions. So, with that, I'd like to thank you for your time and for listening to me, and I wish you a pleasant rest of the day.

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