Recordati Industria Chimica e Farmaceutica S.p.A.

Corusco Conference Operator. Welcome and thank you for joining the Recordati First Quarter 2026 Results Conference Call. As a reminder, all participants are in listen-only mode. After the presentation, there will be an opportunity to ask questions. Should anyone need assistance during the conference call, they may signal an operator by pressing star and zero on their telephone. At this time, I would like to turn the conference over to Ms. Eugenia Litz, Investor Relations of Recordette.

...PFO, who together will present results for the first quarter of 2026. Scott Pescatore, Executive Vice President of Rare Diseases, will then... provide an update on Isteriza, and Milan Draskovic, Executive Vice President of R&D, will provide an update on our pipeline programs. Also joining for the Q&A session will be Alberto Martinez, Executive Vice President of Specialty and Primary Care. As always, the presentation is available in the Investor section.

Good evening. Thank you all for joining us today. We're off to a really good start to the year, as reflected in our Q1 results, delivering excellent financial performance and solid progress across the business. We remain very well positioned to achieve our full year objectives. Starting with net revenue, we reached €730 million, up 4.9% versus last year, or 8.7% on a like-for-like, at constant exchange rate basis. Growth was primarily driven by the exceptional performance of our rare disease business, and the resilient in-market growth of SPC. FX had an adverse impact of 4.3%, largely due to the US dollar. Turning to profitability, EBITDA was $284 million, up 5%, with a sector-leading margin of 39.7%, supported by strong operating performance, a favorable business mix, and disciplined cost management. Adjusted net income increased by 7.2%, to $188 million, while reported net income grew 22.4%, highlighting the strength of our underlying business. We generated 92 million of free cash flow in a quarter, and ended with a leverage just below two times, providing solid financial flexibility. We're also very encouraged by continued progress in our R&D pipeline, The phase two trial of plasireotide in post-bariatric hypoglycemia met its primary endpoint, supporting a meaningful additional opportunity, and we are advancing sutumilab into phase three in IVP. On the commercial side, we're excited about the continued momentum in rare disease, particularly with strength from Isterisa and NGMO. And with that, I now hand over to Mike, to walk you through our Q126 financial results in more detail. Thank you, Rob.

Let's start with the rare disease. We delivered an excellent start to the year with revenues of $292 million, up 14.8% year-on-year, despite an adverse FX impact from the U.S. dollar. At constant exchange rates, growth was 22.4%, highlighting strong underlying momentum in endocrinology and hemo-oncology. both of which delivered double-digit growth. Endocrinology saw strong growth of 38.1%, led by Esterisa, which was up 56.8% year-on-year, underpinned by continued robust patient acquisition in the U.S. across both overt and non-overt Cushing syndrome patient populations, and we remain very encouraged by the significant opportunity in this market, supported by our continued efforts to maximize patient capture. Cignafor grew 6.3%, supported by higher volumes across multiple regions. Emoncology revenues increased 18.2% year-on-year, mainly led by Njamo, which grew 37.6% with strong uptake across the U.S., Japan, and EMEA, reflecting continued market penetration and geographic expansion. Carciva also contributed positively, growing 13.9% across geography. In metabolic, the performance was softer year-on-year, primarily due to lower pan-hematin demand in the U.S. and carboglue phasing effects across geographies, against an exceptionally strong Q1 2025 comparator. With growth driven by volume growth and geographic expansion despite the FX headwind. I'll now turn it over to Scott who will elaborate more on the histories of progress in the U.S.

Great. Thank you, Mike. Thank you, Rob. And as you mentioned, very pleased with the performance of the rare disease business overall in quarter one and particularly underpinned by the exceptional performance of ISTERISA in the first quarter, and the momentum continues to grow and accelerate month on month. And that's really highlighted by the strategic plan that we presented to you some time ago. I'm very happy to say that in terms of the expansion of the field force and the MSL team that is now completed, the team has been trained and they're out in the field, and we expect them to start making an impact immediately. So really good news that we have more people on the ground to further the message around the overt and the non-overt. patient population. We're also increasing our medical education activities, our Congress presence, and continue to generate robust real-world evidence in the communication plan, and that has started since mid-last year. Our patient services continue to grow. ...moments. into new patient starts and really navigating the sort of complex insurance reimbursement process that the patients have to go through in the U.S. market. And finally, I'm very pleased to say that our Phase 4 trial in adults with mild hypercronizolemia and uncontrolled hypertension is on track to start in a few months later this year. And that's really highlighted by the metrics that you can see there on the right-hand side of the slide. And we've had more than an 80% increase in our non-avert population versus quarter two of last year. And that's really sort of the target because that's when we, as you can recall, achieved the extended label forestries and the Cushing syndrome, allowing us to now put on more non-avert patients. And so we're glad to see that that number is increasing. We've had a record number of patient enrollments recently in March, and that's important because those patients will be converted to new commercial patients, and we're seeing that trend continue in April and, of course, into May. So that's a very important metric we'll continue to monitor, but we're very pleased with the performance there. We've expanded our number of new treaters to more than 110 prescribers that were added in the first quarter, primarily in the community, and this is exactly the population where we're seeing more of the non-advert patients. And, of course, that all translates to a very significant volume growth in demand in the U.S. of more than 48% versus the same quarter last year. So, overall, you know, very pleased with the performance and look forward to another strong quarter and quarter two. So, with that, I'm happy to turn it over to Milan, who will give you an update on the clinical trial pipeline.

Thank you very much, Scott. So, on this slide, I'll walk you through our PVH Phase II program. As we have said before, post-bariatric hypoglycemia represents a very significant unmet medical need, and there are today no approved therapies. So on the strength of that, we very recently completed our core phase two trial comparing the serial side to placebo in patients with post-bariatric hypoglycemia. And I'm very pleased to report that the study met its predefined primary endpoint, showing a significant and dose-dependent increase in glucose levels at a standardized meal test. I think very importantly, this also translated into a pharmacological effect in the numerical lowering of level two and level three hypoglycemia. And furthermore, this effect was enhanced in the short group of patients that had the highest baseline hypoglycemia events at enrollment. On the basis of these encouraging results, We plan to meet with the FDA to discuss a pivotal registration of Phase III program. On the next slide, I'm equally pleased to report that we have decided to initiate a pivotal clinical trial for the treatment of patients with chronic refractory immune thrombocytopenia. So immune thrombocytopenia is a rare disease characterized by low platelet counts. This translates into an unmet medical need with an increased risk of bleeding, but actually also an increased risk of thrombosis. Interestingly, in spite of the approved treatment landscape today, there is a substantial residual fraction of patients to the tune of 20 to 30% that are actually inadequately treated and do not obtain, you can say, sufficient platelet responses. In such a very highly refractory patient population, we had early clinical evidence that sutimlimab was actually able to induce a sustained platelet response in around 40% of patients. So based on this strong clinical conviction, combined with very favorable FDA interaction, we are now planning to initiate a pivotal phase three program in around 200 patients with refractory ITP Primary endpoint, also for potential approval, would be durable plato response after 24 weeks. We expect to initiate this PIVOT cell phase 3 trial in the beginning of 2027. And with that, I'll hand it over to Mike.

Thanks, Milan, for the encouraging updates. Turning now to specialty and primary care performance, the quarter reflected the resilient in-market growth of the promoted product, against expected one-off headwinds and a weaker cough and cold season. Overall revenue declined 1% year-on-year to $404 million. At constant exchange rate, the business was broadly stable with 0.2% growth on a like-for-like basis, and the promoted portfolio continued to perform well, growing by 5% for in-market sales. In urology, we delivered a positive Q1 performance driven by Avadar Kambidor, and continued in-market growth of Eligard up 5.5% year-on-year, but this was offset at the reported level by a higher prior-year comparator for Turginan following its relaunch in Russia in 2025. Cardiovascular realized steady in-market growth across key products, while reported sales were impacted by purchasing patterns. The solid contribution from Vascapa at $5.2 million helped offset the loss of Cordicor. Gastrointestinal growth was in line with our expectations. We move to slide nine. This provides a breakdown of the geographic performance for the quarter, highlighting exceptional growth in the U.S., partially offset by one-off headwinds in selected regions. We achieved significant growth in the U.S. with revenues of $150 million, which remains the group's main growth engine. In Italy, revenues were broadly stable, up 1.1%, while Spain delivered solid growth of 12%, and France increased 3.2%, reflecting overall business stability. In Germany, revenues declined 6.9% year-on-year, mainly following our decision to exit unprofitable tenders, a targeted action to protect profitability. In Russia and the wider CIS region, performance was impacted by weaker cough and cold season and a one-off turgid effect following its 2025 relaunch, resulting in a challenging prior year comparison and softer... countries delivered positive growth, while other CEE countries grew 6%. Other international sales declined, mainly due to phasing effects. If we now turn to the P&L, solid revenue growth and a favorable cost of goods mix led to strong margin performance. Operating expenses remained well controlled as SG&A and R&D increased in absolute terms, reflecting our continued investments to support future growth. or remaining broadly stable as a percentage of revenues. At the operating level, adjusted operating income increased to $231.1 million, representing 32.4% of revenues, and EBITDA reached $283.6 million, with a solid 39.7% margin in line with last year. Overall, this performance demonstrates our ability to translate top-line growth into strong profitability. supported by a high-quality portfolio and a structurally favorable mix. If we now turn to the pre-cash flow, the quarterly performance mainly reflected higher working capital absorption and income taxes paid, with the increase in working capital largely intentional, mostly driven by the payout of the stock purchased at the end of 2025 to help mitigate potential U.S. targets. As a result, free cash flow was lower year on year, with underlying cash generation remained strong and in line with our full year expectations. We ended Q1 with leverage just below two times net debt to EBITDA. And finally, we're confirming our full year 2026 financial targets. We expect net revenue in the range of $2.73 billion to $2.8 billion, driven by high teen organic growth at constant exchange rates for rare disease. For SPC, we expect low single-digit organic growth at constant exchange rates, reflecting some one-off headwinds. The fundamentals of the business remain strong, and we are confident to return to mid-single-digit growth at constant exchange rates in 2020. We expect a range of $995 million to $1.03 billion, including investments behind this three's opportunity in the U.S. and the FX headwinds of roughly 4%, leading to sustained sector-leading margins of approximately 36.5%. And for adjusted net income, we expect a range of $655 to $685 million, with a margin of approximately 24%. And our 2027 targets remain unchanged. Go over to Rob to open up the line for Q&A.

Thanks, Mike. Before we do so, and before we enter into the Q&A, I want to make clear that on the theme of a CDC delisting, nothing has happened since we issued our press release. we are not going to speculate when anything relevant would happen. And with that, happy to answer your questions.

Thank you. This is the Coral School Conference operator. We'll now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 on their touch-tone telephone. To remove yourself from the question queue, please press star and 2. Please pick up the receiver when asking questions. Anyone who has a question may press star and 1 at this time. The first question is from Sophia Graf Doolnesson, J.P. Morgan.

Good afternoon, thanks for taking my questions. Let me ask a couple on ISTA-ESA. Is there any further colour that you're able to provide in terms of the phasing of growth that we should anticipate throughout the remainder of the year? How much of an acceleration could we see now that the field force expansion has been complete? And then also, we've seen a strong uptake in terms of the non-overt population year-on-year. What's your current assumption around the rate of diagnosis for the non-overt patients, and what increase in diagnosis rate is assumed in terms of your peak sales guidance? Thank you.

Hi, Sophia. This is Scott. Thanks for the questions. I'll take the first one around the uptake. I believe it was the uptake for the for the year so far. In the uptake, I mean, we're very pleased with what, you know, what we've seen. We expect that there will be a ramp-up now, as you can imagine, from the new people that we're bringing on board. It will take a bit of time for them to embed and obviously start to make an impact, but we do see that we'll see a significant uptake in the second part of the year versus the first part of the year for Isterisa, and that is as per our plan. With regards to the second question, I believe you had a question around diagnosis and what we're seeing there. I mean, you know, we're not tracking on a quarterly basis what our increase in the diagnosis rate is, but obviously having more people in the field, particularly the MSLs, and being present at Congress and starting to talk more about the non-overt population, we are starting to see the pull through because we're treating more non-overt patients in the first quarter than we have, obviously, in this time last year. So the efforts that we're making are still in the very early days. As you can imagine, education around diagnosis and the pull-through there does take a bit of time. But now that we have the full complement of MSLs in the field and new people that are coming on the commercial side, we do anticipate that those rates to continue to increase and for us to pull through additional non-overworked patients in the coming months.

Thank you.

The next question is from Christy Roth-Stewart, BMP Paribas.

Hi, good afternoon. Thanks for taking my questions. Maybe another one for you, Scott, on hysteria. So just a bit more detail on the dynamics of the new patients you're seeing. Are you seeing switches from call-in and what portion of new patients are switches versus naive patient starts? And are you able to tell us kind of what proportion of your currently treated patients are coming from the non-overt population? And then secondly, on signify in PDH, just a question on the peak sales opportunity. I think we've previously talked about this as a potential 150 million population. I was wondering if I could get a bit more, if we can get a bit more detail on the assumptions that underline that assumption, because it could be seen as a little bit conservative given the relatively large addressable market. So just interested in what you're assuming in terms of bariatric surgery rates, penetration, key markets, et cetera, that underlies that current peak sales opportunity. Thank you.

Okay, sure, no problem. So around the number of patients that we have on non-overt versus overt, I mean, again, that is still hovering around the 20% of the population of patients. If you can recall, you know, the non-overt is our core business, and this is something that will continue to drive forward. It's the basis and the foundation for ISTERISA, and that will continue for the foreseeable future as we bring more non-overt patients online. As we also mentioned, I mean, the uptake of the non-overt will take a bit more time because, again, coming back to the previous question, diagnosis, education, and getting those patients on, it is a work in progress. But we're pleased with the uptake of non-overt that we are getting. And as I mentioned during the presentation, the build-out of the sales force is allowing us to go into the community to, of course, you know, try and find more of those non-overt patients to And so we're very pleased with the number of enrollments. And maybe I'll make that clear for you and for everybody else on the call. When we look at the number of patients that we have on therapy, that's very different from the number of patients that actually have prescribed this reason. And as I also mentioned, I mean, the pull-through from enrollments to an active patient is that insurance process, which, you know, is a bit sticky in the first quarter of the year, and it's not just us. There's a lot of change over a of insurances from the Obamacare ending, and there's a bit of churn there. We're seeing that start to smooth out now, but that is something that we and many others in this space, we're also finding we're having far more enrollments than we are active patients, but that's a good sign. That means demand is there. That means people are waiting for their product, and we're very happy to say that the non-overpopulation, the enrollments are above our expectations in that space, and that's really great news. Yeah, and then the switches, I mean, we don't really comment on where we're getting the patients from, but, I mean, I can't tell you specifically the number of patients coming from Coraline, but, you know, we're getting pull-through from, you know, all of the similar channels that we have been in the past, and that continues to drive our patient uptake. With regards to Signifor, you're absolutely right. I mean, it's a dynamic market. We're very excited about that. given what the future may hold once the trial is complete and we do have that product on the market. But I can tell you that we're very excited about the way that market is evolving, and further updates will come in future meetings when we can actually give you a revision of our peak year sales.

Thanks very much. Appreciate it.

The next question is from Nicolas Storer, Kepler Chevrolet.

Good afternoon, thanks for taking my three questions. The first one is about cost of support to ISA in the US. Was Q1 already at cruise speed, as your commentary suggested, or still below the trend leading to the 40-50 million expected? for the full year second question is about extended indication for existing drugs 150 million pixels for a significant new indication Have you ever indicated similar, let's say, indication for sutiblimab engymo? Because if yes, I missed it, if you can recall it. And the last question is about one-off headwind simulation for SPC. It's just related to, let's say, COMPS in Russia. Otherwise, what... are you specifically referring to? Thank you.

Nicolas, acoustically we couldn't quite get the third question.

I heard the word Russia, but that was it. It's about the one-offs in SBC. Is it just Russia?

Yeah it was about the headwinds you mentioned in SPC and I was wondering if those were just related to Russia or also to something else and if this is the case if you can specify what are these headwinds related to?

Okay, so I'll let Alberto comment on that. But there's nothing new and unexpected happening in SBC. In fact, everything that is happening was expected. The cough and cold season does impact Russia, but not only Russia. It has impacted countries like Turkey, France, and we've seen it not just with us, but there's been a very low season in that in general. But I'll let Alberto comment on that a little bit more before I do. maybe just on the opportunity in PBH. Like Scott said, we have indicated before peak year sales in the range of about 150 million. We're very excited by the opportunity and at this point we're not updating it. Much like also Christy already indicated, there's many people out there who believe that this is a significantly bigger opportunity and we're excited about it. The results are very good and this is a strong unmet medical need, so we will advance as fast as we can. You didn't miss a guidance on ITP, because we haven't given one and we will not. opportunity is there. We are very much aware of the time and cost needed to develop this, but we believe that the opportunity is more than adequate to tackle this. There is a significant group of people with current therapies available, simply not well controlled, and from our first Phase 1 trial data, we know that there is a very good possibility to control for about 40% of patients in ITP within JMOs who are excited about that opportunity. Maybe first pass to Mike on a little bit of the evolving costs around the step up in his Teresa expenses and then let Alberto comment on what is unexpected or not. In fact, I don't think there's a lot of unexpected in the SPC.

Yeah, so in terms of the ramp-up of costs to support InstaResa, Q1 is not at full speed yet. We'll get closer to that in Q2. You know, a lot of the reps were being brought on in the back half of Q1, as well as some MSLs and a few others. And then we'll see some other costs ramp up. So I don't think we'll be at full speed probably until Q3, Q4. But we are on pace to invest a little bit more this year and then have a four-year impact in 2027. So, Alberto, I'll pass it to you for the SBC.

Thank you, Mike. As Rob mentioned, the unexpected is essentially the cough and cold season. That is the factor, as we have seen also being reported from other companies. A low season has been happening across most markets, particularly in Central Eastern Europe, which impacts Russia, but also we've seen it in other markets, also including Italy. and that obviously has an impact as you can see in the growth levels. Aside from that is the usual expected impact that we know Cardicor and one of Terginan which is a local product in Russia that was relaunched last year and has that effect but still our urology portfolio continues to to grow and we are confident to be able to bring it back into positive growth terms in the coming quarters. Perfect, thanks Ed.

Thank you. The next question is from Martino D'Ambrogi, Equita.

Thank you, good afternoon everybody. Two more questions on Isturiza. In Q1, you added 110 prescribers. Could you remind us what is the total number nowadays? And in terms of active patients, in the last presentation, you indicated 1.4 thousand in the U.S. Frankly, sorry if I missed it. Could you remind what is this number at the end of the quarter? And changing the subject on tariffs in the U.S., can we say we are safe? So never say never, obviously, but let's say under the current regulation there is no more risks so far. And in Germany, have you any visibility on the ongoing discussion if it's really affecting your portfolio in Germany or not? And very last, on the Signifor BPH, okay, pixels is clear, your comment. Could you elaborate on the best estimate for the timing? Thank you.

Thank you, Martino. Lots of questions. So maybe on Germany, we do not see a real impact on our portfolio with the recent discussions and changes in the system. Of course, we follow it quite closely. The timing for PBH, I'm happy to pass over to Milan, and we'll take the other questions in sequence on this, Teresa.

Thanks, Robin. Thanks for the question on PBH. On the timing, what we said was that we will be meeting with the FDA to discuss, you can say, a pivotal Phase 3 program. Once we have full understanding of that, we may be able to provide further clarity, but at this point in time, I think it's premature.

So we do expect that one phase three trial will be enough, but before we haven't agreed the exact timing and details of that trial, I think we should not guide you on exact timing, but it will require that one phase three trial. in indication to really make sure that we have a dossier that is ready to be filed. Your question on tariffs, I don't know, rare disease seems to be in a good space in this discussion. What we have done proactively and Mike alluded to, inventory build-up that we did intentionally, and that is actually with the aim to mitigate any potential risk coming from a tariff increase in the U.S. I'm happy to say that 426 were absolutely secure and have been able to bring products to the U.S. that even if there would be a tariff, for which we have no sign at the moment, and there seems not to be any immediate possibility that this comes, but even if it would, it would not impact our 26 figures at all. Maybe on Istheresa, Scott? Sure, thanks Rob.

A couple of questions on Istheresa. The first one, let me start the second one first, which is the total number of Istheresa patients that we have. on treatment, and we closed at more than 20% additional patients in the first quarter. But again, I sort of would like to revert a bit back to the number of enrollments that we've had, because enrollments is really the true measure of demand, and that is far exceeding our expectations in the first quarter. Basically, what we're seeing, as I mentioned, is the net more of the function of the patients that are pulled through from the enrollment. So, you know, we have seen, as I mentioned in the first quarter, a bit of a delay in getting those patients from enrollments to net active patients. So I think a more fair measure of the performance is the enrollments, which I can tell you is going very, very well, particularly, as I said, in the non-overt population. So we're very pleased with that. And that's a factor as your first question, which is the number of the prescribers we have. I don't have the total number of prescribers to share with you, but I can tell you that the new prescribers that we're putting online, many of them are coming from the non-over population, which again is a good sign of the momentum starting to build in that space. And that is again a function of us getting out into the community and talking to more of these physicians around patients who have difficulty to treat hypertension vis-à-vis the Cushing syndrome. So I think all in all, the metrics are all trending in the right direction, and we've seen a really nice uptake in the first quarter.

Okay, thank you. Very last follow-up. Over the 40, 50 million additional costs this year to push historiza sales, how much was in Q1 if you commented it?

Now, we just commented on the last answer that we weren't at full speed. We're not going to give an exact number, but we'll be at full speed in the second half, so a little bit less than a quarter of that. Okay. Thank you.

The next question is from Natalia Webster, RBC.

Hi there. Thanks for taking my questions. Firstly, a follow-up on history around the 110 new prescribers in Q1. I wanted to ask how sustainable you see this level of increase going forward. Secondly, on Cigna 4, PBH, the Phase 2 hit its primary endpoint on glucose levels, but the hypoglycemia reduction was non-significant. So I just wanted to ask how this frames your thinking on the regulatory path from here, particularly for the Phase 3 primary endpoint. And then finally, Just on M&A, appreciate you're not going to talk on the discussions with CDC, but are you able to comment on whether this has changed your strategy around evaluating BD opportunities?

Thank you. Thanks, Natalia. Let me take the last question of the week. We are fully committed to continue as we have to be disciplined on M&A, but continue to pursue opportunities. both in SPC and in rare disease, and we have a multiple of discussions ongoing. I think someone has his line open and makes a whole lot of noise, but the SRM&A strategy hasn't changed, and if anything I think, I don't want to speculate what the future will hold, but I would be surprised if anything would change other than just even stepping up seriously. So this remains to be extremely important for recordality, and we keep focused on it and are actively engaging.

Maybe I'll jump in with the first question around the new prescribers. So the new prescribers are very important for us because it's obviously a factor of the non-overpopulation and the uptake because we're getting new prescribers online who are giving us these patients that are first-time writers. And many of those prescribers only have one patient. But I think it's important also that we recognize the repeat prescribers and how we have many, many prescribers who are prescribing to new patients and to multiple patients in this Teresa. So I think it's really important to look at both of those. But we've presented the new prescribers because, again, it's really a function of how many of the non-oberts are coming from the community from these new prescribers. And again, you know, we expect that number to increase because this is pivotal for us to get to those people, to get patients on in the non-overt space. So we anticipate those numbers to improve and to continue to grow over time. Maybe I'll hand over to Milan for the question.

Yes, thanks for your question. So when it comes to the pivotal program, obviously, we will be discussing this with the FDA. It is our expectation that it would be around, you can say, level 2 and level 3 hypoglycemia that would be the primary endpoint. It is into a clinically meaningful improvement, in particular in the subgroup of patients that had, say, higher baseline event rates, and that allow us to make informed decisions around sizing, et cetera, of a potential phase 3 trial. Thank you.

Great, thank you. Gentlemen, there are no more questions registered at this time. I turn the conference back to you for any closing remarks.

Thank you. Thank you, Alfred. And thank you for your questions and engagement. You can see that we are very happy with our results, not just in terms of the financial performance, the market share on both businesses doing even a little better, better than at least the market seemed to have expected and we're very happy with it. We're confident to be able to keep the momentum and I'm also particularly happy with the fact that we've been able to enrich our pipeline and we're making really good progress in R&D with some meaningful opportunities for patients and economically, financially, commercially interesting opportunities for for Recordati that we will keep you updated on. Thank you for spending time with us today and look forward to meeting you in the next opportunity. Have a good day.

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