Ipsen S.A. (IPN) Earnings Call Transcript & Summary

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 slides. Once the Q&A session is ended, don't log out. You'd 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 day's presentations will be recorded and can be accessed by 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 market as IPSEY. Over to you, Craig.

Okay. Thanks, Zaf, and hello, everyone. So you heard Zaf said Ipsen of France, but you can probably tell my accent isn't so French. So I'm calling -- dialing in from a not so sunny U.K. It's a fairly typical day, in November in the U.K. today. So 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. So I joined Ipsen nearly 3 years ago, and I've seen the business hugely transformed in that time and it become, I think, an attractive proposition for the market. So 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 can. So this is our safe harbor statement. And all growth rates you'll hear today will be at constant exchange rates unless specified otherwise. So I'll kick off with the investment case of Ipsen. So Ipsen for those of you not familiar, is a French biopharmaceutical company. And when I say French, it's based in Paris, but it used to be effectively a French company. And now it's a global business with a head office in Paris, and that's quite different than how it used to be. So the fastest region of growth for us right now, representing around 1/3 of our sales at the moment is the U.S. So we see that as the real engine of growth going forward. And what we've done over the last couple of years, it's really narrowed down our focus on to Specialty Care. We did have a consumer business, a consumer health care business that we divested over 12 months ago. So now we have a business that purely focuses on 3 therapies: oncology, neuroscience and rare disease. But the second element of our global footprint is our global presence. We're in over 100 countries right now around 35% and over 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 of external innovation. So we don't really have that many people in white coat 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 not refilling our pipeline, replenishing our pipeline that has led to a number of potential launches over the next 2 years or so. So it's quite an exciting time at Ipsen that we're a reasonably quiet news flow company up until around 12, 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 innovation strategy, where over the last 2 years or so, we 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 -- slightly familiar with Ipsen from before, we used to be very dependent on 1 medicine that I'll talk about in a moment, that was generating nearly half our sales at around half our profits. That medicine now represents around 1/3 of our sales and falling. And we now have multiple shots on goal with a number of medicines across a range of indications. And then the final element of the investment case is our balance sheet. We have a very strong balance sheet that we use for our capital allocation priority #1, 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 2 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 5 compelling elements of the investment case. So as I said, our vision is really to be that leading global player in midsized biopharma. We realize we're not going to 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 U.S. as we introduce and launch more medicines into the U.S. business. And we're focused on those transformative medicines across those 3 therapy areas. We were very, very weighted towards oncology. And you'll see over the next 2 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 formats and so what we bracket our growth platforms. So these are medicines that have either been around for a little while or are reasonably new. But clearly, as you can see on the slide, delivering very strong growth. So as a combination, Dysport in neuroscience and Cabometyx, Decapeptyl, ONIVYDE in oncology continued to deliver strong growth for us when you combine them. And they're typically growing between 15% to 25% in combination each quarter. Dysport, just to explain, is effectively our Botox. We're typically in markets either #2 or sometimes #1, 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, trauma 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 in a number of near-term headwinds in China in terms of the economy. But overall, China is an attractive market for Decapeptyl. And then ONIVYDE, I can take you through later on, 1 of the significant opportunities we've got with the potential FDA approval in February, that would significantly accelerate the potential of ONIVYDE. Somatuline, you can see in the middle, that's been gradually declining now for some time. This is used to treat Botox 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. Where you can see that now we can occupies around 1/3 of our sales from around half our sales that I mentioned earlier on. So that went -- it lost its exclusivity in the U.S. in December 2021. So we've seen some competition coming to the U.S. in that class. And also around 2.5 years years ago, we saw generic competition in Europe. So we've managed the decline well. You've seen, on average, 10% to 15% decline each quarter year-on-year for Somatuline, and we continue to assume that will decline gradually. The moment -- 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 form of blood cancer that again, 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, 1 of the rarest diseases in the world are very, very debilitating and terrible disease, called FOP. And that was approved by the FDA in August, and we're in the process, we're launching that across the U.S. right now. So we see growth potential and opportunities right across the new medicines and our growth platforms, which together represent around 2/3 of our sales versus Somatuline -- 1/3. 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 medicines I talked about, plus further external innovation in the introduction of more medicines via by in-licensing and other forms of agreement that will come into the fold, come into the portfolio and coming to 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, if you look at the U.S. specifically, we -- this time last year, we broadly had 3 medicines in markets -- this time next year, we could have 7. And those medicines have the potential to deliver a very strong contribution to the group over the long term. 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, maybe Europe. So Europe, we have less. So we don't have rights, for example, to ONIVYDE in Europe. And ONIVYDE is 1 of those strong potential opportunities for us. So as a proportion of sales, I would 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 now or 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 9 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 platform is up by 16%. As I was saying, Dysport, Cabometyx, Decapeptyl and ONIVYDE combined growing by 16%. And we're seeing nice contributions now from these new medicines Bylvay in rare disease, TASVERIK, oncology and SOHONOS in FOP in rare disease. We're making good progress with our 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 await further data on that before we'll know the full picture. We're certainly seeing initial data so far that was positive. With Bylvay, we had that approved in a second form of rare liver disease called allergial 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 allergial syndrome next year, some say next year, probably around the middle of next year, something like that. And then elafibranor, which is really the #1 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 2 years ago. And this is our opportunity in a form of rare disease called PVC. Now we will present that full data set of elafibranor from the Phase III data that will be presented next week at the AASLD Medical Congress in Boston, and we will have a Q&A call after the data is fully presented to answer the market's questions on the data itself. And then the final element of this page is really the guidance. So we 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 I think overall, a strong performer. We continue to do well and managed over the last few years to manage that decline while Somatuline, which has faced a 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 2 key messages to this slide. So across our clinical development pipeline, you can see now that we are broadly, nicely split between oncology, rare disease and neuroscience. This was very blue 2 to 3 years ago. So we were, 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 asset 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, where you 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 trial both in Phase II and Phase III. PSC which is Primary Sclerosing Cholangitis in Phase II affects predominantly men, whereas PVC in Phase III predominantly impacts women. We see this as a significant opportunity. And next month at our Capital Markets Day will be giving our P sales estimates for a number of these opportunities. So I think overall, good opportunities across oncology, across rare disease. And finally, on this page, I'd like to draw your attention to our longer-acting neurotoxin, in Phase II in green at the bottom of the page. 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 typically, a neurotoxin in this space may deliver you around 12 to 16 weeks' worth of treatment impact. The idea behind these trials in Phase II and potentially then in Phase III is in critical concept right now would be to deliver 6 and maybe up to 9 months' worth of impact, which will be game changing. And we are excited about that opportunity, although clearly, it's still at an early stage and is a medium-term opportunity. And then finally, Dysport in green at the bottom on Phase III is a new trial. We've -- there's actually 2 trials we've initiated for Dysport in migrane. And migraine is a large market. It's dominated by 1 player right now, but we also realized that 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 kind of stolen this from our Q3 results. I mean, effectively, our sustained strategic success is delivering 2 things. One is the growth momentum. Our growth platforms, which occupy nearly 2/3 of our top line continue to perform well, and we're seeing a nice increase in contribution from those 3 new medicines. On our pipeline, we've seen a number of milestones successes. For example, 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 for patients and certainly for the market because of the numbers that we continue to print. And then finally, I'd like to draw your attention to 2 things in the diary. So I alluded to the 14th 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 7th of December, the webcast, that is in person in London and invitations by -- attendance in person is by invitation. So let me know if you'd like to attend. And that's going to be on the 7th of December. We will really set out the medium-term shape orbits and the opportunities we've got to continue growing and transforming. So that was my presentation. I clearly went to a little bit over. So I'm just going to go to the questions. So 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 we have said over time, 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%. Some of that was driven by the Zoom. People see themselves on Teams and Zoom and so on and realizing they need to hide the sell for you. And if they can't find that button, they tend to sometimes consider getting a short of Botox or short of Dysport. So that's clearly been a short-term fillet to the market. But we're not going to continue growing at such a high rate. But at our Capital Markets Day, we'll certainly give you more idea as to where we think Dysport can go. On Cabometyx, 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 going to go. But at our last Capital Markets Day, we did say on a non-risk-adjusted basis, we did say -- sorry, on a risk-adjusted basis, we said EUR 700 million or 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, certainly for us, we continue to see opportunities. We turned down many, many opportunities. But I think it's fair to say we are -- certainly Ipsen has 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 -- we have 8 medicines in market. We will potentially have a ninth next year with elafibranor, but we don't have 100, and therefore, we can give a new asset, the focus it deserves. It can get -- it can take. The management time we can take the resources of the business to really drive the potential of our asset. I think also a global footprint, as you can see how many countries we're in, either directly or indirectly and they're expanding presence and our -- certainly our sales, marketing and R&D basis around the world means that we can really drive the potential of those medicines hard. So -- and I also think the quality of our executive management team, our senior team, I think is exceptional. We continue to recruit better, replacement better is how I feel. And I certainly think the quality will be 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 will continue to be opportunities, whether it's in oncology, whether it's in rare disease, I think probably neuroscientists, it's -- you have to clearly be careful in neuroscience. You have to be exactly clear on what you want. 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 1 of the 3 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 will continue to be opportunities, including in oncology. The next question, you noted static FX rates does a company disclose FX hedging coverage rates. So we've said for this year, we actually, originally before October 26, our Q3 results, we said that FX would mean a headwind to our top line of 3%. We now think it's going to 3.5%. So we don't disclose -- we certainly don't disclose our forward contracts or our hedging contracts and how much we hedge. But certainly in terms of FX is getting a little bit more difficult. We clearly hedged a significant proportion of our exposure. But we have -- do have a significant business, for example, in Russia with our, for example, our therapeutics Dysport business. So clearly, there are challenges there. So we have been hit by FX this year. If you look at our Q3 results, our share price is down on a day principally because of FX because the rest of the business, the underlying conditions, trading and performance was unchanged. The next question, 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 we've -- I'd suggest it depends on what line you're looking at, but the most significant investment we've made this year was the acquisition of Albireo that we announced at JPMorgan in January and closed at the start of March. So that was a sizable transaction over GBP 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 to TAZVERIK in hematology. So the investments we're making, 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, 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 we're working with me at the moment on our Capital Markets Day. And I have to say that the quality right throughout that business has been, for me, very, very strong. So I'm particularly pleased with the Albireo acquisition. And also the principal asset that came across was Bylvay which is in market that's only recently been launched in of the 3 rare liver disease indications that we're looking at. But certainly, it's performing very, very well, continues to outpace analyst expectations each quarter. And we're seeing a nice launched 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 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 the -- 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 1 moment just to see if there's any more. Okay. So it looks as there are no more questions. So with that, I'd like to thank you for your time for listening to me, and I wish you a pleasant rest of the day.