Recordati Industria Chimica e Farmaceutica S.p.A. (REC) Earnings Call Transcript & Summary

Good morning, and welcome to the Recordati session of the 4th JPMorgan Healthcare Conference. My name is Sophia Graeff Buhl Nielsen. I'm an analyst here at JPMorgan on the European pharma and biotech team. And today, it's my pleasure to introduce the CEO of Recordati, Rob Koremans. We also have with us for Q&A, Scott Pescatore, Head of R&D; and Mike McClellan, CFO. [Operator Instructions] And with that, welcome, Rob, to the conference.

Thank you. Thank you. And I'd like to thank JPMorgan for getting the opportunity to present an update. Really pleasure to bring you up to date with our recent development and focus on how we're unlocking our true potential in rare diseases. My name is Rob Koremans, and I'm the CEO of Recordati. Before we do, I have to point out the usual risks of -- and inherent to the business forward-looking statements summarized in this slide. This year is actually an interesting year for Recordati because it's exactly 100 years ago that we were founded in Italy in a small town called Correggio. Over the -- we will celebrate it appropriately. And over the last 100 years, our company has developed into a fully integrated full-fledged pharmaceutical company with a global reach in rare diseases and a European reach in our SPC business unit. We employ about 4,500 people worldwide. and have a very, very strong track record of organic, but also inorganic growth with deals and M&A. Rare Diseases is our fast-growing part in the business with high teen growth in the high teens in percentage. It's about 40% of '25 revenue with very attractive margins. And in terms of growth versus the year before, actually in the first 9 months was 29.2%, but also on the back of the acquisition of Enjaymo that we just completed at the end of the year before. So we have now almost 1 year of Enjaymo with us. And on a like-for-like basis, has grown 14%. And the majority of the business still is the SBC. I internally often refer to it as our diesel engine. It keeps growing at about 4%, 5%, mid-single-digit growth. It is a European-focused business with sector-leading margins of 35% EBITDA and continue to do quite well. We're on track to deliver for the '25 within guidance. That performance is going really well, and we're very pleased with how we are tracking and will deliver on all of our financial parameters as guided for '25. That's not just been in '25 that we are delivering. We have an extreme strong track record of delivering on our -- or overdelivering on our promises, which if you look at the growth, the cash that we've been generating, profitability and the discipline we've executed in both cost, but also in the way we do M&A, we've been able to generate very attractive return of capital employed of 15% to 20% over the last decade consistently. We are known to really deliver on what we promise, and we have no intent to change that whatsoever. Also for this year, like I already highlighted '25, the numbers, of course, are not consolidated and final, but we're well on track to deliver on the -- just above EUR 2.6 billion revenue. and also well on track, notwithstanding some of the headwinds from currency, notably the dollar, we're well on track to -- and confirm our targets for '27 as well. As a team, we're extremely proud of the value we've been able to generate for our shareholders over the last decade and long before that as well. And you can be assured that this continues to be our focus going forward. You've seen also notably a bigger part of this coming from the Rare disease, which you, here, see in red, but a consistent and nice development of SPC. There's only been 1 year, actually 2020, where we lost some exclusivity of 2 of our products, which gave unexpected dip. And there was the COVID, which I think impacted every single pharmaceutical company in the market in some way or fashion. Other than that, I think consistently overdelivered and very much intend to continue to do that going forward. We have a very solid foundation and a proven track record that positions us really well for the next phase of growth. Our consistent financial performance that I already alluded to, not only do we generate growth, but we also have sector-leading -- really sector-leading EBITDA margins and a very, very attractive return on capital employed. We've enhanced our value drivers, most notably in rare disease, where we've been bringing on products that have a lot of room to grow, not just in the indications at hand, but also in expanding the indications through life cycle management, very targeted and geographic expansion. And that's exactly what we're doing, and I'll give you a little bit more background to that going forward. But also in the SPC part, where over the last 5 years, we've reduced our sales forces by up to 20% in Europe, but impact on the market has been actually positive because we've been outperforming the market, increasing our competitiveness as measured by the evolution index in the market by 4% to 5%. So we've been really able to target the right doctors and deploy the right approaches to get our messages across and keep our products growing steadily. We have a strong track record in M&A and are very proud of the products we brought in. But it's not just bringing in the products. It's afterwards making sure that we integrate them really fast. Enjaymo is with us just over a year, has been fully integrated. Teams are up and running, and we had a target for last year of EUR 150 million in revenues, one that we will achieve, notwithstanding the currency impact of the dollar. And that's only because we really set out to make that integration. And the way we do BD is a little different from what most companies did that I worked for in the past. We integrate this with BD and our business combined, and this worked really well. Then we have a fairly derisked what sets us apart from many other companies, even within our rare disease portfolio of over 20 products, this is per se already derisked. But combine that with SPC, the geographic spread we have, the breadth of business, we don't have a real big exposure to any geography, although the U.S. is our most dominant market. It represents about 20% of our business. And it is, in that sense, a derisk, which in these volatile times, we believe is important to maintain and is something that we work hard. The other part of the derisk is that there is negligible risk of loss of exclusivity and a very focused targeted R&D spend with not a lot of risk inherent into the programs as we expand into other indications with known products that are already on the market. So inherently have a lower risk. Then I'm very proud to be able to lead a what I would call top world-class leadership team with very diverse backgrounds, nationalities and very experienced, which is, I think, the key thing in driving our company forward successfully. I go a bit more into the detail of rare disease. It's a global business from Japan to the U.S. and Brazil and just about everywhere Korea, we have our businesses, people on the ground. On an annual basis, this has now already achieved EUR 1 billion in revenues, and it's growing at high-teen percentages. In fact, with the acquisition, it was over 20% with also very attractive EBITDA margins. I already said, we have over 20 orphan or ultra-orphan products across 3 therapeutic areas: endocrinology, oncology and metabolic. We see, for instance, in metabolic, we have in a country like the U.S., we had on one of our products, Carbaglu, 3 generics on the market. Actually, there are 2 left. And frankly, we have not lost one unit in volume. Of course, we had to adapt our prices. But these products, even if there's generic entries that happened only 5, 6 years after we lost exclusivity, and they were small molecules, so easier to make. They are protected because of the nature of the business, the intimacy with the patients, the services we give. These are attractive market going beyond that. And then often when it's biologics and the sales are just too small for anyone to try and make a biosimilar. So the nature of this business is not only that you can get to market faster, but you can also maintain your revenues much longer than what you would see in a typical pharma business. On oncology, there is a -- I'll give a little bit more detail there. That was the result of an acquisition of EUSA now 4 years ago. In endocrinology, we acquired products from Novartis now 6 years ago and have been expanding them. You'll see more in the coming slides. We're present just across the world, Australia, Japan and North America, which we've been building quite significantly, tripled our presence in the last 3 years and investing in things like production locally, clinical trials and definitely also an organizational ramp-up. The drivers of growth are actually mostly on the hemato-oncology and endocrinology and specifically endocrinology, and I'll give a bit more detail afterwards, is a very exciting opportunity to grow, specifically Isturisa going forward quite significantly. To be able to do that, we also maximize the opportunity through targeted R&D and life cycle management going to new indications, but also spread new geographies, which we believe is important to fully maximize the opportunity for single products. Metabolic 15 products was the foundation. We were one of the first movers into the rare disease now 18 years ago. These products are still very important, alive and kicking with really nice margins and important to the patients that we serve that will -- that help to address very, very serious diseases that they depend for the quality of their life and their life on with some of these products. Hemato-oncology with about a EUR 300 million revenue, growing at 70%, but largely also related. It's a lot of organic growth, but of course, also the acquisition of Enjaymo that came in at the very end of the year before has helped to do that. In Qarziba, we are really well positioned. This product is available in all of the world, but the U.S. It's the preferred product in the treatment of serious neuroblastoma in children mostly. And we believe there's opportunities to expand into the U.S. as well for this and working hard together with the FDA to drive and achieve that. Sylvant, a unique therapy, the only registered therapy to treat a disease called castlemans. We are increasing the diagnostic rates. We are growing therapy rates. It's doing really well, and there still is ample room to grow this product globally. And then Enjaymo the only product registered for cold agglutinin disease, an exciting product is doing really well, like I already said, it will achieve the EUR 150 million that we targeted for '25. The momentum is strong. We are very, very excited about it. And also soon, we'll take -- we've had an interaction with the FDA on bringing this product into ITP. We feel strongly encouraged by this interaction. And in the coming weeks, we'll have all the information together to take the go, no-go decision into trying to develop this indication as well for Enjaymo. And then on endocrinology, Isturisa, 6 years on the market, started in Europe into Cushings syndrome and Cushings disease in the U.S. only had the Cushings disease label with very clear people, very overt patients. And then in April last year, we got the label extension into Cushings syndrome, and this has opened up an opportunity that I'll give a little bit more detail on later on, but we are strongly convinced that this is an opportunity to be able to capture these specifically non-overt patients and see a potential of achieving peak year sales of at least EUR 1.2 billion in this combined globally. Signifor, very interesting, very important, mostly used in acromegaly, second or third-line therapy, strong position there. And we feel encouraged also by the new guidelines that give an opportunity to further expand. And we're exploring, and I'll talk a little bit further down also to use this product also in the treatment of post-bariatric hypoglycemia, a strong and important market where the opportunity is probably as big as for the Signifor per se in its current indication with potential sales of at least EUR 150 million as well. And Phase II data are expected in the second quarter of this year. So soon, we'll know how good this product really is in this indication, and we can give more updates on that. Looking at Isturisa. The patient uptake in the U.S., we've actually doubled the number of patients from 24 to 25 at year-end '25, had 1,400 active patients on therapy. With the label extension in April, we've seen a good uptake also of the so-called non-overt patient, the milder Cushings patients, where they start with a low dose and they're every 12 weeks titrating up to the effective dose that they need like they do in Cushings disease, where these patients need to carefully be monitored and titrate up. The product is doing extremely well, very positive feedback, and we feel very encouraged by this and quite confident that within Cushings syndrome, there is an incredible opportunity looming. But this will require further screening, different therapy patterns and referrals. And of course, it will require patients with milder syndromes, also to be put on therapy. And I'll give you a little bit more detail on that. And we started off specifically in the U.S. with Cushings disease. These are patients with a very strongly elevated cortisol level, often 3 to 5x the normal. And you would pick them up in an audience almost immediately. You can actually diagnose them with face recognition software. It's -- they're very overt patients. They will continue to be important going forward. There were about 4,000 to 5,000 currently today, and we believe this will increase a little bit going forward to 5,000 to 6,000 patients. And some of them use very, very significant amount of our product. But the average dose is 6 to 7 milligrams a day. And with the label that we got, we now have the opportunity and addressing this actively to also go for a different type of patients that do not present immediately as clear Cushings patients, Cushings syndrome patients are often picked up by the fact that they have therapy resistant or hard-to-treat hypertension or diabetes. And you look in your screen their cortisol and they are 1 to 2x higher than normal and lowering this cortisol level could actually be the key to treating their hypertension or diabetes. This is, at the moment, relatively small group because it's fairly new inside of about 2,000 to 3,000 patients. And we expect that this will ramp up, and this is on a lot of solid market research and working closely with all the opinion leaders in this field. It will tenfold probably going forward in the next years, and that represents a real opportunity for us to go after. And that's what we have decided to do. We have the label, but we decided to continue to ramp up our investments as well, and we'll spend about EUR 40 million to EUR 50 million additional to just be able to get to those patients and talk a little bit more of what we do, but it's field force, it's MSLs, it's real-world evidence generation, and we are initiating a double-blinded placebo-controlled Phase IV study, so not a pivotal trial, but we want to generate data on the effectiveness of Isturisa in helping to control hypertension for patients that so far have not been able to get their hypertension controlled. So we're really excited about this opportunity and already see the impact in our patients' numbers, as I shared with you, with a very nice and good ramp-up. SPC, fantastic business. We're very proud of it. It doesn't have the growth potential in terms of 20%, 15% per year, but a solid 5% constant exchange rate is what we've achieved. 400 brands, all brands. These are not generics, but we have the unique and original brands in here, mostly in urology, cardiology and in gastroenterology and also nonprescription products, OTCs. We have feet on the ground in 30 countries in Europe and the broader Europe countries like Tunisia, Ukraine, Russia, Turkey, where we are present. A very, very strong focus on promotion-sensitive products where we've been able to increase profitability in the last years and bring down also the expenditures in that. And we are very confident that we can continue to drive this business with a single -- mid-single-digit growth going forward. I already dwelled a little bit on the life cycle management and BD. BD has always been very important. We also in '25, brought in Vazkepa in our cardiovascular portfolio in SPC. It's doing extremely well so far, and there's a nice opportunity to continue the growth in the cardiovascular space. We've integrated Enjaymo successfully in the last year, which was important talked about the label extension in Isturisa, and we've finished the enrollment for our Phase II study in PBH with pasireotide, which we expect to be able to share in the second quarter of this year and '26. initiated Qarziba in Ewing sarcoma, which is a potential interesting opportunity. And we have a BLA pathway for Qarziba potentially established with we feel strongly supported by the FDA, but we'll have to, from an ongoing trial, deliver a couple of extra patient data to be able to really submit the BLA to them. And then we'll, in the coming weeks, take a decision on ITP, but feel strongly encouraged by the feedback from the FDA. And then to end up, so like I already said, we feel very strongly confident that we will deliver on our promise for '25. Notwithstanding the FX impact, which was really strong in the year and also in '26, we expect a strong impact from our FX. We will end up, as we already communicated at the lower end with a strong and beautiful result for '25 and also confirm our targets for '27. In '26, we will suffer a little bit, as we have already communicated on the SBC business from 2 facts. One, is we are losing one of the products with a EUR 35 million revenue because the license is ending. That's the only product in the EUR 400 million where this could happen, and it has happened. We are offsetting that with growth and especially Vazkepa, but it will impact the margin for '26. We also had -- there was no price increase in Turkey for '25, but I'm happy to be able to announce that actually the prices have increased in January of this year. So '26 has started off with a 17% price increase for Turkey. So that seems to be a better situation. But we will continue to feel the FX headwinds on revenue, about 3% for the year on the EBITDA, about 2%. So that's something that we have to just take into account. And then the margin is also going to be slightly impacted by the step-up investments for Isturisa. All in all, we feel extremely confident on our business, very proud of the momentum and very confident that we are on track to also reach our long-term aspiration and happy with where we are and what we do. And with that, end the presentation and open up for questions.

Great. Thank you for the presentation. Do we have any questions in the room? If not, maybe we could start out with the exciting update you shared with us at Q3 just on the doubling of your peak sales guidance for Isturisa. You also spoke about a bit of the investments that you need to make over the course of the coming years to support this launch. Maybe you could tell us a bit more about your focus for investments for this year. And then more towards the midterm, how should we think about the trajectory towards that peak sales target that you've put out there?

Scott, do you want to want to?

Sure. Thanks for the question. So just to reiterate the upgraded guidance that we gave last year, I mean we still see a very exciting opportunity and a high unmet need in this additional cohort of patients with Cushing’s syndrome, as Rob outlined, a minute ago, this so-called nonoverter/mild population. This is an extension of the Cushing syndrome population, patients that tend to have cortisol levels that are just about 1 to 2x upper limit of norm, which is obviously a less severe form of the disease. But nonetheless, they're suffering from comorbidities like hypertension and hypoglycemia. And we've seen activity and we have patients currently on histories and now that are benefiting from lowering the cortisol levels to appropriately treat these persistent hypertension, hyperglacemia levels. So we continue to focus on that, and this is where the source of the investment that Rob had mentioned before. We're investing in additional field force, because many of these patients do exist outside of the primary centers or in the community. So we need more people on the ground to go visit the community centers throughout the U.S. But really screening diagnosis and education is really the most important thing that we can be doing right now. Hence, we're putting more MSLs in the field and investing in those opportunities to continue to educate not only endocrinologists, but also primary care physicians and cardiologists. They're not our core group, core group is, of course, endocrinologists, and that's where our strategy lies, but these patients are sitting in other treating -- treatment areas in PCPs and in cardiologists. So they will be important for the longer term that will allow us to continue to reach our peak year guidance where the education and the referrals will come from those two other treatment pathways. And as I said, this is a significant opportunity. We're very excited about this opportunity. As Rob mentioned, also, it's been well validated not only by our own market research, but by our own sales uptake and the numbers that you saw a minute ago, where we landed in 2025 post April. There are patients that are on the mild setting there. And we continue to see the uptake in the early weeks of January, and we anticipate having a very successful year based on not only the uptake of the over population. And of course, Cushing’s disease because those patients are very important, of course, but the addition of these new patients in the mild setting.

And just to that end, considering the education that is required and perhaps the longer diagnosis pathway for the milder patients, how important will the Phase IV your running be towards that process of accelerating the ramp in diagnosis?

So the Phase IV is an important trial for us to generate additional data, mostly around the starting dose and to reinforce the data that we already have. We don't need to do an additional data with the FDA. I mean our label is FDA approved, with Cushing’s syndrome. These patients are clearly able to be treated within our current label. The work that we're doing, not only with the Phase IV, but also real-world evidence trials, which will be opened and somewhat completed even this year is important for us to reiterate the physicians and to reinforce the data that we have that this product that works, it's safe, and that -- to give them a bit more guidance on how they can titrate these patients because it's a bit more sensitive than the overt patients where you clearly have a disease that has a much higher cortisol burden, the titration and the starting dose is clear in our label. But what we're doing is generating additional data to help these physicians guide them a bit more on these patients that have a lower cortisol level and a bit more sensitive to the dose titration.

And perhaps a bit more color. I think your peak sales guidance is currently based on the 35% market share for the U.S.? Towards the end of the year, we saw a competitor get a CRL for their product. Does this have any impact in terms of your thinking towards the potential market share you could have in the space?

We really -- I mean, I can't comment on the CRO. I mean, I don't -- we don't know the details, and we don't know what their strategy will be to bring that product to market. So for the time being, we're not going to adjust our market share. Clearly, if there's a delay or, let's say, a nonentry at that point, then, of course, it's something that we'll look at when we have more details, and we'll adjust the market share accordingly. But clearly, they're a competitor, and there is market share associated with their product, but we'll have to see. It's too early right now.

It makes sense. Maybe just thinking about another one of your products within Enjaymo. Sorry, Rob, are you going to add to?

No, no, I fully agree with what Scott said. I think at the face of it, it looks like more like an opportunity than a threat to us. But we need to see the CRL and fully understand the implications. At the moment, we just continue to do what we do, and there's plenty of that building on our own strength, which we have initiated the additional indication, new people all of these initiatives in real-world evidence and Phase IV trial that we're initiating. I think that's enough for us to really be able to get into that market. And we'll see what happens with Corcept.

Thank you. So on another one of your products for Enjaymo, you're trending towards your EUR 150 million target for this year. Peak sales guide of EUR 250 million to EUR 300 million. What is that growth rate based on? Is that continued geographic expansion? Is that also another case of increasing diagnosis rates? If you could you expand upon that?

Maybe I think one thing that -- and I'll let Scott finish, but, Enjaymo is a wonderful product for a disease that needs to be treated by has cold agglutinin disease is not always front of mind for hematologists, but it is a disease that impacts life expectancy has an increased thromboembolic event. So it's a fairly serious disease. What we need to make sure that hematology understand on a daily basis, deal with oncology patients that this is as serious and they need to really take the treatment series. And that is the education that is behind it that will allow for the penetration. We're extremely well on track to do this. And we are also getting to know the product better, right? So there's a bit of a seasonality because it's temperature-dependent, all these things we need to understand, but we're very excited by the opportunity and actually confirmed that the target is really realistic. And that's always important for us. It addresses a true unmet medical need people in need and they're exposed to a higher mortality risk and very, very significant symptoms that really impacted the quality of their life quite significantly. To make sure that hematologists also fully appreciate that and know how to deal with this, is the education that's ongoing.

Yes. And just to add to that, I fully agree. There is a significant portion of untreated patients that are still obviously left for us to tackle. Geographical expansion is important. We will be expanding in some countries across Europe and other markets, which we can share more detail on. It's minor and compared to the focus that we have, which is in Japan. And in the U.S. But really, as Rob mentioned, I mean, CAD is a disease that it's up to us to continue education to ensure that patients -- the physicians understand the urgency to treat these patients. And that's really where we see the biggest uptake in our -- in the future is to get these patients that either aren't diagnosed or are diagnosed and aren't treated the urgency to treat to make sure that they understand that these patients can benefit greatly from Enjaymo, which, by the way, is the only approved treatment for CAD and getting them on products as quickly as possible and then maintaining those treatments for the duration.

And you mentioned we also have a potential update in terms of the no go no-go decision for Enjaymo and ITP. Could you talk about indication selection where you see the areas of unmet need within this indication? And then also then how you're thinking about the opportunity for Enjaymo and ITP?

Sure. So we have very good activity that shows Enjaymo has activity in ITP, and we're excited about this opportunity. It's a crowded market space, but we were very encouraged by the FDA meeting that we had just in December. They have sort of approved our pathway to move forward. Our development plan has been endorsed by them. So we're excited about that. And we have a bit more work that we need to do in terms of of what sort of market penetration that we'll have with Enjaymo because there are several products that are either approved or in development there. And so now it just comes down to us really just kind of consolidating the market feedback with the FDA feedback and moving forward with that program. But we do see a place in the ITP treatment pathway for Enjaymo that we'll be moving on.