Recordati Aktie

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Recordati First Half 2026 Results Conference Call. [Operator Instructions] At this time, I would like to turn the conference over to Ms. Eugenia Litz, Vice President of Investor Relations of Recordati. Please go ahead, madam.

Thank you, and good afternoon, everyone. I'm pleased to be here today with Rob Koremans, our CEO; and Mike McClellan, our CFO, who will present results for the first half of 2026. Also joining for the Q&A session will be Scott Pescatore, Executive Vice President of Rare Diseases; Alberto Martinez, Executive Vice President of Specialty and Primary Care; and Milan Zdravkovic, Executive Vice President of R&D. As always, the presentation is available in the Investors section of our website. It is now my pleasure to pass the call over to Rob. Please go ahead.

Thank you, Eugenia, and good afternoon, everyone. Thank you for joining us today. We are very pleased with our performance in the first half of the year. We delivered another period of strong financial results, continued to execute well across businesses and maintained the momentum that positions us to achieve our full year objectives.

Revenue increased to EUR 1.4 billion, representing a 6.6% reported growth or 9.1% on a like-for-like at constant exchange rate basis. This performance was driven by the continued strength of our rare disease portfolio alongside resilient in-market growth across our Specialty and Primary Care business.

EBITDA increased 8.8% to EUR 540 million, delivering a margin of 38.3%, reflecting the quality of our portfolio, favorable product mix and a continued operating discipline. Adjusted net income grew 6.7% to EUR 350 million, while reported net income increased 24.8%, supported by the strength of our underlying business.

Cash generation also remained robust. We generated EUR 299 million of free cash flow during the first half and further strengthened our balance sheet, ending the period with a net debt below 1.9x EBITDA. This gives us considerable financial flexibility to continue investing in our business while pursuing value-creating business development opportunities.

Operationally, Rare Disease continues to be the key engine of our growth. In the U.S., Isturisa delivered strong performance across all major demand indicators, supported by increasing physician adoption and growing patient demand. During the quarter, we also completed the planned expansion of our customer-facing teams.

In addition, we took another important strategic step by expanding our pipeline through our licensing agreement with Ionis for Zilganersen, further reinforcing our long-term Rare Disease growth platform. And with that, I'll hand over to Mike, who will take you through the financial results for the first half of -- in more detail.

Thank you, Rob. Turning to Rare Disease. We delivered another strong performance in the first half with revenues increasing 17.1% to EUR 604 million or 22% at constant exchange rate. Growth continues to be broad-based across the portfolio with particularly strong contributions from endocrinology and hemo-oncology. Within endocrinology, Isturisa once again delivered an outstanding performance, growing 58% year-over-year. This reflects continued momentum in patient acquisition and conversion, underpinned by strong commercial execution.

We continue to see significant opportunities for growth as physician adoption expands and more patients gain access to treatment. Signifor also contributed positively, increasing 5.8%, supported by higher volumes in the U.S. In heme-oncology, revenue increased 14.8%, led by Enjaymo, which grew 31.1% on continued expansion across the U.S., Japan and EMEA. We also had solid contributions from Qarziba and Sylvant, demonstrating the breadth of growth across the franchise.

As expected, metabolic was lower versus a particularly strong prior year comparison, reflecting the timing of Carbaglu shipments across markets and softer demand for Panhematin in the U.S. It is reinsuring, however, that the franchise returned to growth during the second quarter. Overall, these results reinforce the strength of our Rare Disease portfolio, providing a solid foundation for future growth.

If we turn now to Specialty and Primary Care, the business delivered another resilient performance in the first half. Revenue was broadly stable at EUR 774 million, up 0.6% on a like-for-like basis at constant exchange rates, which reflected continued growth of our promoted portfolio despite a number of expected headwinds during the period. In Cardiovascular, revenue declined 1.6%, reflecting the anticipated impact of the loss of Cardicor together with lower sales of certain mature products due to order phasing.

These headwinds were partly offset by continued success of Vazkepa, which contributed EUR 14 million of revenue in the first half and ongoing growth from Pitavastatin. Urology increased 1%, driven by continued strong performance of Eligard, supported by solid underlying demand and a temporary competitor stock-out in Turkey.

This was largely offset by a more challenging comparison for Tergynan following its relaunch in Russia last year. In Gastrointestinal, revenue increased 3.9%, reflecting primarily good momentum for Procto-Glyvenol across our key markets.

Finally, Cough and Cold declined 9.7% as expected due to a weaker season across our major markets compared with the prior year. Overall, we are pleased with the performance of the Specialty and Primary Care business. The continued strength of our promoted brands and resilient underlying demand largely offset the expected impact of product losses, order phasing and seasonal factors, which reinforces the quality and stability of this portfolio.

If we now go to geographic performance, the first half was characterized by continued strong momentum in the U.S., which more than offset a number of expected headwinds in selected markets. The U.S. once again delivered a great performance with revenue increasing 29.5%, or 38.2% in local currency, driven primarily by Isturisa and Enjaymo.

In Italy, revenue declined 8.5%, reflecting the expected impact of the loss of Cardicor. Spain continued to perform strongly, growing 12.2%, supported by Vazkepa, while France declined 5.3%, primarily reflecting lower sales of mature products and phasing effects. In Germany, revenue was down 6.6%, mainly reflecting our deliberate decision to exit selected low-margin tenders, consistent with our focus on maintaining profitability.

Russia, other CIS countries and Ukraine increased 7.7% in EUR terms despite the softer cough and cold season and a tougher comparison following the Tergynan relaunch last year. Turkey continued to deliver excellent growth, increasing 16.2% and 34.3% in local currency, reflecting strong underlying demand across the portfolio with price increases more than offsetting the currency deflation.

Elsewhere, Portugal, other Western Europe and other CEE countries all delivered growth, while other international sales were modestly lower, largely reflecting phasing of shipments. Overall, we're pleased with the performance across our geographic footprint. Strong growth in the U.S., together with solid contributions from several key international markets helped offset localized headwinds and demonstrates the resilience of our diversified business model.

Now if we turn to the P&L, solid revenue growth and a favorable product mix drove strong profitability and margin expansion in the first half. Revenue increased 6.6% to EUR 1.4 billion, supported by the continued momentum of our diversified portfolio. Gross profit increased 14.3% with gross margin improving to 71.5%, benefiting from strong operational performance, a positive mix effect and the absence of prior year acquisition-related inventory charges.

Operating expenses maintained well controlled, while SG&A and R&D increased in absolute terms as we continue to invest behind the growth of the business, both remained broadly stable as a percentage of revenue, demonstrating continued operating discipline, though we expect a slight ramp-up in the second half as the additives Isturisa investments in the U.S. reach a full run rate. Non-recurring costs increased due to the acceleration of the performance share plan in the second quarter, triggered by the potential delisting of Recordati.

Net financial expenses increased mainly driven by unrealized FX losses from the U.S. dollar. Reported net income increased 24.8% to EUR 269.7 million, while adjusted net income rose 6.7% to EUR 349.9 million, with a margin remaining strong at 24.8%. Finally, EBITDA reached EUR 540.2 million with a 38.3% margin.

We now turn to the cash flow, we generated EUR 299.4 million of free cash flow in the first half, an increase of EUR 42.6 million versus the prior year, reflecting the continued strength of the underlying business. The improvement was primarily driven by higher EBITDA, while working capital usage remained broadly stable year-on-year.

Higher income tax payments were more than offset by a favorable contribution from changes in other assets and liabilities. And we continue to maintain a strong financial position, ending the first half with a net debt below 1.9x EBITDA.

And finally, we are confirming our full year 2026 financial targets. We expect net revenue in the range of EUR 2.73 billion to EUR 2.8 billion, driven by high-teen organic growth at constant exchange rates for rare diseases. For SPC, we expect low single-digit organic growth at constant exchange rates, reflecting some one-off headwinds while the fundamentals of the business remain strong.

For EBITDA, we expect a range of EUR 995 million to EUR 1.030 billion, including the investments behind the Isturisa opportunity in the U.S., leading to a sustained leader [ accepting ] margins of approximately 36.5%. And for adjusted net income, we expect a range of EUR 655 million to EUR 685 million with a margin of approximately 24%. Our targets for 2027 also remain unchanged. With that, I'll turn it back over to Rob to open up the Q&A session.

Thanks, Mike. And before we do so, I would like to remind everyone that the proposed transaction with CVC and GBL is subject to an ongoing offer process. The offer document was published on July 22 and is publicly available, together with Recordati's Board statement and the opinion of the independent directors.

As all relevant information is contained in these publicly available documents, we are not able to comment further on the transaction beyond what has already been disclosed. We would therefore appreciate keeping today's discussions and Q&A focused on our business, our performance in the first half year, and are now happy to take your questions.

[Operator Instructions] The first question comes from Charles Pitman-King from Barclays. Charles from Barclays.

A few, if I may. Just thinking about some of the dynamics on your product sales. Within the cardiovascular business, Livazo in particular, kind of showed very strong 1H sales. I'm just wondering if you could describe a little bit more around what the key driver of this was.

And you mentioned order phasing. Was this a factor here? And how does it affect your other cardiovascular products? And then secondly, maybe with urology, you mentioned about Eligard strength. Are you able to quantify any of the benefit related to the stock-out? Is this expected to reverse? And just how can we think about that Tergynan offset?

This is an unfamiliar product at least from my perspective. And then maybe just a quick final one on SPC margins. They look like they're coming down over time despite I assume most of the margin being the incremental SG&A being allocated to R&D to Rare Disease. So just wondering how you're thinking about SPC margins over time.

Thank you, Charles. It was not all acoustically as clear, I'm sorry to say on the -- but your question on cardiovascular, there's -- I'm happy to give Alberto the floor.

Thank you, Rob. Cardiovascular, there are different dynamics. I think you specifically referred to Livazo, Pitavastin. This is driven by a strong growth primarily in Russia and Turkey, which are markets where we do promote this product. But it's also partly because of the repatriation of a brand of these products in Spain that we undertook from the beginning of the year in January, bringing the product from Esteve into Recordati, while previously, the product was in the hands of international.

All of that combined is bringing a higher growth of Livazo than expected. But the market dynamics remain solid and continues to grow, but more in the single digits than in the double digits. Then I think you mentioned as well about the other phasing dynamics and spreads around metoprolol and lercanidipine.

There are different dynamics there with competitors out of stock with different situations in Romania with a significant crisis, both political and economic that is influencing the sales of Betaloc. But overall, the product continues to perform well on an in-market basis.

The same is applied to lercanidipine, where we see also some phasing dynamics with one of our partners, Menarini, this year that is reducing the level of stock that they have or API in their business, but the in-market demand continues to be very strong in the relevant markets for Menarini, which is Russia and CIS markets primarily. So hopefully, that covers -- I could -- do you want to cover the SPC margins, Rob, or you want me to cover it?

No, happy to do that. I believe what we're doing on margins has been based on three things, right, is one, wherever there's an opportunity to increase the price and where we have the flexibility, we do so if the market circumstances allow. We continue to be very efficient in our operations and continue to focus on that.

And we believe that these margins that we are now are sustainable and the rightsizing that has happened on the commercial part to a large extent and that we communicated already a couple of times is behind us. So it's really more in the mix where we have. And I don't know, Alberto, anything you want to add here?

No, it's just to say that the margin of SPC has just been improving over recent years, also thanks to a significant rightsizing of our commercial operations. We also have to recognize that we are relaunching Vazkepa and as a product at launch phase, we need to invest, and that is minimally impacting the margins of SPC.

But the margins of SPC according to what we see remains very strong and well above any other peers in the specialty care space. I don't know if you have any other questions that were uncovered because it was not that clear the sound.

Yes, thank you. Sorry, the other question just related to urology, just the Eligard versus Tergynan dynamics. Wondering if you could quantify the competitor stock-out benefit for Eligard and just what we should be considering for Tergynan given this is an unfamiliar product.

Eligard continues to grow robustly in the market. It's mid-to-high single-digit growth on -- across the regions. We obviously have declared before that there is higher competition in the space with the arrival of some new competitors, some innovative products coming in the market. But Eligard, unlike other ADTs is defending very well and effectively growing as being reported.

One exceptional event is the fact that in Turkey, the main competitor went out of the market. And today, Eligard is the only ADT available for patients, and we have been able with a huge effort from our supply chain to meet the needs from the patients, and we are seeing an exceptional performance from -- of Eligard in Turkey.

And obviously, that is an effect that is not expected to be sustained in the future. We don't know how long that competitor will be out of the market, but -- and therefore, will have a reverse effect at some point. But we are reporting it transparently as soon as it happens as we always do. In the case of Tergynan, it was the relaunch last year in Russia. We reported it as well last year. And now we are seeing some influence of that in the overall growth of urology. But so far, it's also a good performance of Tergynan in Russia and in other territories.

[Operator Instructions] The next question comes from Kirsty Ross-Stewart from BNP Paribas.

Kirsty Ross-Stewart from BNP Paribas. So maybe a couple for Scott. On Isturisa, I know that in Q1, you were mentioning some delays of converting patients into commercial prescriptions. So just wondering if you could provide an update on this. Has there been any improvement in your conversion rate since Q1? And if so, or if not, what's kind of driving that?

And if I can try and push you for kind of a number, just quantify any improvement versus Q1 and how much progress towards the optimal scenario, which I guess is kind of full patient conversion. That would be very helpful. And secondly, just on the zilganersen that you've been licensed from Ionis. I think the U.S. opportunity is estimated around $200 million in consensus. So just wondering if you could talk to the relative size of the opportunity in the markets that you have rights for and the time lines behind development and approval here.

Sure. No problem. Thanks for your questions. I appreciate it. So with regards to Isturisa, you're absolutely right. I mean we were seeing a bit of a slow conversion rate in the first quarter. This has picked up significantly in the second quarter. We've had almost more than 20% additional conversions versus the first quarter. So we did see some pull-through there, which was very positive news. But this is a metric that needs to continue to improve.

We have significant enrollments, which are coming in, and they've increased also very strongly in the second quarter, but we really need to pull those through into conversions. If you're asking sort of what are some of the things that are driving that, I mean, I think we mentioned in the last call, we did have a bit of churn because of some insurance pull-through and some Obamacare expiring and people kind of bridging their therapy in the first quarter.

That's washed out in the second quarter a bit. We still have a bit of that churn, but it's less than in the first quarter. So it's smoothing a bit, which is helping the conversion. We're also seeing -- we are seeing significantly -- a significant number of new prescribers, which is also generating some of the slow conversions because clearly, not being familiar with the product or the processes, it is taking a little bit more time to get those patients on drug.

However, some of the things that we've seen in the second quarter are repeat prescribers and prescribers that have had more than one patient on therapy. So the conversion from enrollment to new patient start has been quite a bit smoother with them.

So we continue to see this progression for the rest of the year, and it's something that we're going to be focusing on trying to manage ways to make this easier for physicians and for patients to make sure that when they get the prescription for Isturisa that they can actually receive the drug as quickly as possible. And I think your second question was on Ionis, on zilganersen product.

We have not guided, and I don't think it's a good point now to give a guidance on this opportunity. As you know, it's an ultra, ultra, ultra-rare disease. And the pricing outside of the U.S. where we are going to be responsible for bringing this to patients is going to be different from in the U.S.

But I don't want to guide on an opportunity here. It's a wonderful opportunity for patients that suffer from this because it's a very effective treatment for a very small but severely impacted patient group.

Ladies and gentlemen, there are no more questions registered at this time.

Yes. And I'm not surprised because many of our -- I think we've had very clear and solid results, and we're a bit limited in what we can say and who can participate and ask questions. So I would like to thank you for joining us today.

And we are committed to maybe enjoy a little bit of a summer break here in Italy and then continue our businesses. Look forward to seeing you and speaking, talking to you next. Thank you all, and have a good day.

Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Recordati First Quarter 2026 Results Conference Call. [Operator Instructions] At this time, I would like to turn the conference over to Ms. Eugenia Litz, Investor Relations of Recordati. Please go ahead, madam.

Thank you, and good afternoon, everyone. I'm pleased to be here today with Rob Koremans, our CEO; and Mike McClellan, our CFO, 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 Isturisa; and Milan Zdravkovic, 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 & Primary Care. As always, the presentation is available in the Investors Section [Audio Gap]

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 EUR 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 U.S. dollar.

Turning to profitability. EBITDA was EUR 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 EUR 188 million, while reported net income grew 22.4%, highlighting the strength of our underlying business. We generated EUR 92 million of free cash flow in the quarter and ended with a leverage just below 2x, providing solid financial flexibility. We're also very encouraged by continued progress in our R&D pipeline.

The Phase II trial of pasireotide in post-bariatric hypoglycemia met its primary endpoint, supporting a meaningful additional opportunity, and we are advancing sutimlimab into Phase III in ITP. On the commercial side, we're excited about the continued momentum in rare disease, particularly with strength from Isturisa and Enjaymo.

And with that, I now hand over to Mike to walk you through our Q1 '26 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 EUR 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 Isturisa, 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's syndrome patient populations. And we remain very encouraged by the significant opportunity in this market, supported by our continued efforts to maximize patient capture.

Signifor grew 6.3%, supported by higher volumes across multiple regions. Hemo-oncology revenues increased 18.2% year-on-year, mainly led by Enjaymo, which grew 37.6% with strong uptake across the U.S., Japan and EMEA, reflecting continued market penetration and geographic expansion. Qarziba also contributed a positively, growing 13.9% across geographies. In metabolic, the performance was softer year-on-year, primarily due to lower Panhematin demand in the U.S. and Carbaglu phasing effects across geographies against an exceptionally strong Q1 2025 comparator. We expect performance to stabilize in the coming quarters. Overall, the quarter once again demonstrates the strength and quality of our rare disease portfolio with growth driven by volume growth and geographic expansion despite the FX headwinds.

I'll now turn it over to Scott, who will elaborate more on the Isturisa 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 1 and particularly underpinned by the exceptional performance of Isturisa 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 been started since mid last year. Our patient services continue to be enhanced, and we're continuing to refine and grow that very important service that we provide to patients. And this will help us to facilitate the pull-through from the enrollments 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 IV trial in adults with mild hypercortisolemia 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-overt population versus quarter 2 of last year. And that's really sort of the target because that's when we, as you can recall, achieved the extended label for Isturisa in Cushing's Syndrome, allowing us to now put on more of non-overt 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-overt 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, very pleased with the performance and look forward to another strong quarter in quarter 2.

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 will walk you through our PBH Phase II program. So 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 II trial comparing pasireotide 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 2 and Level 3 hypoglycemia. And furthermore, this effect was enhanced in the subgroup 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 registrational 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 III program in around 200 patients with refractory ITP. Primary endpoint also for potential approval will be durable platelet response after 24 weeks. We expect to initiate this pivotal Phase III trial in the beginning of 2027.

And with that, I will 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 EUR 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 end market sales.

In urology, we delivered a positive Q1 performance driven by Avodart/Combodart 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 Tergynan 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 Vazkepa at EUR 5.2 million helped offset the loss of Cardicor. Gastrointestinal growth was led by Procto-Glyvenol, while cough and cold was weaker year-on-year, reflecting a softer seasonal pattern across several key markets as expected. Overall, performance was in line with our expectations.

We move to Slide 9. 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 EUR 151.6 million, up 25.1% year-on-year or 39.1% in local currency. This was driven by continued momentum in rare disease, 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 Tergynan effect following its 2025 relaunch, resulting in a challenging prior year comparison and softer [Audio Gap] 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 investment to support future growth, while 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 EUR 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 free 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 purchase at the end of 2025 to help mitigate potential U.S. tariffs. As a result, free cash flow was lower year-on-year with underlying cash generation remains strong and in line with our full year expectations. We ended Q1 with leverage just below 2x net debt to EBITDA.

And finally, we're confirming our full year 2026 financial targets. We expect net revenue in the range of EUR 2.73 billion to EUR 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 2027. As for FX, we're estimating an approximately negative 3.5% impact on revenue, driven mostly by the U.S. dollar. For EBITDA, we expect a range of EUR 995 million to EUR 1.03 billion, including investments behind Isturisa 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 EUR 655 million to EUR 685 million with a margin of approximately 24%. And our 2027 targets remain unchanged with strong organic growth expected to be complemented by ongoing BD and M&A despite facing currency headwinds.

And with that, I'll turn the call back to Rob to open 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 CVC delisting, nothing has happened since we issued our press release. We are not going to speculate on what might happen going forward, and we'll definitely not answer questions related to this topic, but of course, keep you updated if anything [Audio Gap] would happen. And with that, happy to answer your questions.

[Operator Instructions] The first question is from Sophia Graeff Buhl Nielsen, JPMorgan.

Maybe just a couple on Isturisa. Is there any further color 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 about -- 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.

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 year so far. And the uptake, I mean, we're very pleased with 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 Isturisa, 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, 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 congresses and starting to talk more about these -- 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 actually -- we do anticipate that those rates to continue to increase and for us to pull through additional non-overt patients in the coming months.

The next question is from Kirsty Ross-Stewart, BNP Paribas.

Maybe another one for you, Scott, on Isturisa. So just a bit more detail on the dynamics of the new patients you're seeing. Are you seeing switches from Korlym and what proportion 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 Signifor in PBH. Just a question on the peak sales opportunity. I think you've previously talked about this as a potential EUR 150 million opportunity. I was wondering if I could get a bit more -- we can get a bit more detail on the assumptions that underlying 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.

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, the non-overt is our core business, and this is something that we'll continue to drive forward. It's the basis and the foundation for Isturisa, 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, the 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, try and find more of those non-overt patients to pull through. And so we're very pleased with the number of enrollments. And I just -- 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 Isturisa. And as I also mentioned, I mean, the pull-through from enrollments to an active patient is that insurance process, which is a bit sticky in the first quarter of the year, and it's not just us. There's a lot of changeover 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 were -- 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-overt population, the enrollments are above our expectations in that space, and that's really great news.

Yes, 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 Korlym, but we're getting pull-through from 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. At the current time, we're not changing our peak year sales, but we are investigating exactly how that market is evolving, how the surgery rates are changing given the GLP-1s in the region and 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.

The next question is from Niccolo Storer, Kepler Cheuvreux.

The first one is about cost to support Isturisa in the U.S. Was Q1 already at cruise speed as your commentary suggested or still below the trend leading to the EUR 40 million, EUR 50 million expected for the full year? Second question is about extended indication for existing drugs, EUR 150 million peak sales for Signifor new indication. Have you ever indicated similar, let's say, indication for sutimlimab because if yes, I missed it, if you can recall it. And last question is about one-off headwinds you mentioned for SPC. Are these just related to, let's say, comps in Russia. Otherwise, what are you specifically referring to.

Niccolo, 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 SPC. Is it just Russia.

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 SPC. 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. Yes, like Scott said, we have indicated before peak year sales in the range of about EUR 150 million.

We're very excited by the opportunity. And at this point, we're not updating it. But much like also Kirsty 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. The 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 who are with current therapies available simply not well controlled.

And from our first Phase I trial data, we know that there is a very good possibility to control for about 40% of patients in ITP with Enjaymo. So we're excited about that opportunity. Maybe first pass to Mike on a little bit of the evolving cost around the step-up in Isturisa 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.

Yes. So in terms of the ramp-up of costs to support Isturisa, Q1 is not at full speed yet. We'll get closer to that in Q2. 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 full year impact in 2027. So Alberto, I'll pass to you for the SPC.

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 and 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 the one-off of Tergynan, which is a local product in Russia that was relaunched last year and has that effect. But still our urology portfolio continues to grow, and we are confident to be able to bring it back into positive growth terms in the coming quarters.

The next question is from Martino De Ambroggi.

Two more questions on Isturisa. 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 1,400 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, peak sales is clear, your comment. Could you elaborate on the best estimate for the timing.

Thank you, Martino. Lots of questions. So maybe to -- 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 Isturisa.

Yes. Thanks, Rob, and 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 III 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.

And maybe, Martino, to make -- so we do expect that one Phase III 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 III 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 buildup 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 for '26, we're 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 Isturisa, Scott?

Sure. Thanks, Rob. A couple of questions on Isturisa. The first one, let me start with the second one first, which is the total number of Isturisa patients that we have on treatment. And we've closed at more than 20% additional patients since -- 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 enrollment is really the true measure of demand, and that is far exceeding our expectations in the first quarter.

Basically, what we're seeing is, as I mentioned, is that the net patients that are on therapy is more of -- they're more of a function of the patients that are pulled through from the enrollment. So 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 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 or many of them are coming from the non-overt 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 difficult-to-treat hypertension vis-a-vis the Cushing's 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. Very last follow-up. Over the EUR 40 million, EUR 50 million additional costs this year to push Isturisa sales, how much was in Q1, if you commented it?

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 1/4 of that.

The next question is from Natalia Webster, RBC.

Firstly, a follow-up on Isturisa around the 110 new prescribers in Q1. I wanted to ask how sustainable you see this level of increase going forward. Secondly, on Signifor PBH, the Phase II hit its primary endpoint on glucose levels, but the hypoglycemia reduction was nonsignificant. So I just wanted to ask how you just frame your thinking on the regulatory path from here, particularly for the Phase III primary endpoint. And then finally, just on M&A. I 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.

Thanks, Natalia. Let me take the last question. 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 have a multiple of discussions ongoing. I think someone has its line open, it makes a whole lot of noise. But the -- so our M&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 Recordati, and we keep focused on that and are actively engaging.

And 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-overt population 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 Isturisa.

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-overts are coming from the community from these new prescribers. And again, 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 Signifor 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. I think the important point here from my side is also that on the strength of the Phase II results that we now have, we have what I see as visibility 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 III trial. Thank you.

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

Thank you. Thank you, operator. 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 than at least the market seem 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. We're making really good progress in R&D with some meaningful opportunities for patients and economically, financially, commercially interesting opportunities 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.

Ladies and gentlemen, thank you for joining. The conference is now over, and you may disconnect your telephones.

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Recordati Full Year 2025 Preliminary Results Conference Call. [Operator Instructions]

At this time, I would like to turn the conference over to Ms. Eugenia Litz, Investor Relations of Recordati. Please go ahead, madam.

Thank you, and good afternoon, everyone. I'm pleased to be here today with Rob Koremans, our CEO; and Mike McClellan, our CFO, who will present preliminary results for full year 2025. Scott Pescatore, Executive Vice President of Rare Diseases, will then provide an update on the exciting Isturisa opportunity as well as a recent deal with Moderna. Also joining for the Q&A session will be Alberto Martinez, Executive Vice President of Specialty and Primary Care; and Milan Zdravkovic, Executive Vice President of R&D. As always, the presentation is available in the Investors section of our website. It is now my pleasure to pass the call over to Rob. Please go ahead.

Thank you, Eugenia, and good morning, good afternoon wherever you are in the world. Thank you for joining us today. We're delighted to share our strong results for the full year of 2025. Last year, we once again delivered on our financial targets, executed across the business and further strengthened our foundation for continued growth in the years ahead.

Starting with net revenue. We reached EUR 2.62 billion, an increase of 11.8% versus last year or 8.3% like-for-like at constant exchange rates. Growth was driven by the sustained momentum in SPC and an exceptional performance in rare disease. As expected and already guided before, we saw a strong currency impact with minus 2.7%, primarily due to the U.S. dollar and also the Turkish lira.

Turning to profitability, EBITDA came in at EUR 991 million, up 14.5%, sustaining sector-leading margins of 37.8%, thanks to strong operating performance, positive business mix and very disciplined cost management. Adjusted net income increased 14.5% to EUR 651 million, while net income grew 6.5%, highlighting the underlying strength of our business. With EUR 559 million of free cash flow in '25, we ended the year with a leverage just below 2.1x, providing us with a solid financial flexibility.

2025 was also a pivotal year for business development across SPC and rare disease. We signed the Vazkepa licensing agreement with Amarin last June. And in December, we further expanded our rare disease footprint in Japan through a regional agreement with Impact Biomedicines, a Bristol Myers Squibb subsidiary, to commercialize Inrebic for myelofibrosis. In January of this year, we entered a global partnership with Moderna for the development and commercialization of mRNA-3927, that Scott will allude to a bit further on in the presentation.

On the commercial side, we're encouraged by the continued progress of Enjaymo and the progress and significant opportunity ahead for Isturisa, which Scott will also expand upon shortly. With that, it's now my pleasure to hand over to Mike for his first basically performance update on Recordati's behalf and to walk you through full year '25 financial results.

Great. Thanks, Rob. Happy to be here. Starting with rare diseases, we delivered a robust performance in 2025 with strong double-digit growth, up 29.7% year-on-year despite increasing U.S. dollar headwinds, or 16.6% like-for-like at constant exchange rates. The endocrinology franchise grew 22.5%, driven primarily by Isturisa, which increased almost 30%. This reflects an acceleration of patient uptake in the U.S. in the second half of the year as well as solid growth across all geographies. Signifor also delivered good growth of 11.2% driven by higher volumes across regions.

For hemo-oncology, Qarziba and Sylvant both grew by double digits. And Enjaymo achieved a strong performance with sales reaching EUR 146 million, representing 26.7% growth versus last year at constant exchange rates despite a significant adverse FX impact in the U.S.

Lastly, it's great to see the metabolic franchise delivering solid mid-single-digit growth in what was an exceptional year, driven by Panhematin and Carbaglu. Overall, Rare Diseases remains a key driver of the Group's performance, supported by strong execution, expanding patient access and continued demand for our therapies across all major markets.

Now I'll turn the call over to Scott to elaborate on the exciting Isturisa opportunity and our new Moderna partnership.

Great. Thank you, Mike. It gives me great pleasure to provide a bit more color on Slide 5 around the performance of Isturisa in the last quarter of 2025. We continued the strong patient uptake that we saw post the FDA approval of the expanded label in April and we closed the year with just around 1,400 net active patients on therapy. I think, importantly, to mention that not only do we see additional patients that are being put on to Isturisa, but also that the patients that we have on therapy continue to up-titrate to the appropriate levels to maintain their treatment, which is allowing us to achieve also our financial objectives with the product.

Just to provide a little bit more color also on some of the investments that we had mentioned we're making in 2026 to capture the broader Cushing's syndrome market. We are in the process of expanding our field force in the U.S. We're adding additional field personnel on the commercial side, but also importantly, additional MSLs to support medical education and diagnosis of these non-overt patients, which should be in place by the end of quarter 2 of this year.

We're also working extensively on improving our medical education and plans with CME events and medical congresses to support also the expanded opportunity. We're also continuously improving our high-touch patient services at our specialty pharmacy partner, Anovo. And finally, we're initiating new and innovative digital NIA initiatives that will continue to raise the awareness of patients that are not only suffering from the overt severe hypercortisolemia, but also the non-overt less severe version of the disease.

So if you move to Slide 6, I'm also very pleased to have the chance to talk to you a little bit about the deal that Rob had mentioned that we closed earlier this year with Moderna to develop and commercialize mRNA-3927 for propionic acidemias. A few words on what propionic acidemias are. They are very rare inherited metabolic disorder that basically prevents the body from processing and breaking down certain parts of proteins and fatty acids. This leads to a buildup of toxic metabolites and basically allows patients who -- particularly neonates to failure to thrive, causing seizures and all kinds of other issues and systematic complications that eventually can lead to death or complications in adulthood.

There are no disease-modifying treatment options at the moment, but mRNA-3927, which is an investigational product still, is aimed at restoring this PCC enzyme activity in patients with propionic acidemias. We're excited about this deal because it fully complements our existing Rare Disease metabolic portfolio. As many of you know, we have Carbaglu that we've had in the market for many, many years now. And this is certainly an innovative new approach to treating these patients that builds on our legacy in Rare Diseases with the specialists treating these metabolic disorders.

We expect that the patient enrollment for the ongoing clinical trial to read out by the end of this year. And you can see a bit of the deal terms on the slide. We paid an upfront of USD 50 million with some additional near-term milestones that totaled to about USD 110 million. And I think important to mention that we don't expect any significant impact on our EBITDA prior to the potential launch of this product. As we know, Moderna will continue to lead the development of mRNA-3927. And if approved, we'll then be the commercial stewards for this product moving forward.

So with that, I'll hand it back over to Mike for the rest of the presentation.

Great. Thanks, Scott. Turning to Slide 7. Specialty and Primary Care, we delivered resilient growth of 3.8% at constant exchange rates, excluding Vazkepa. This result was driven by the continued strong performance of our promoted portfolio compared to the reference markets across most countries. Importantly, this momentum held despite a softer cough and cold season in key markets such as Russia and Italy, as well as a broader slowdown in reference market growth.

Shifting to Turkey, we're very pleased that we secured a 17% price increase at the start of 2026, as the last increase was in Q4 2024. Broadly speaking, I'm encouraged by the performance of many of our prescription and OTC products across therapeutic areas. Both the urology and cardiovascular franchises delivered stable growth, while gastrointestinal franchise achieved high single-digit growth. Meanwhile, Vazkepa continues to track fully in line with expectations, reaching EUR 9 million in sales in 2025. Taken together, these results highlight the strength, resilience and diversification of the franchise. Our promoted brands continue to be the primary engine of growth, demonstrating the effectiveness of our commercial execution and market strategy.

If we go to Slide 8, looking at the revenue by geography. It's nice to see that overall, there was growth across most of the regions, with a few expected headwinds in Italy and Turkey. The U.S. grew almost 32%, driven by the Isturisa ramp-up and Enjaymo, and in local currency grew even higher at 38% versus the previous year. There was a solid growth across European countries with the exception of Italy, which was impacted by several factors, including a softer growth in the reference markets. Strong growth in Russia and Central and Eastern Europe were driven by both volume and select price increases.

Turkey continues to deliver strong volume growth. However, the full year 2025 performance reflects less impact of the late 2024 price increase as compared to the significant currency devaluation during the year. In local currency, revenue grew 28%, confirming the operational performance remains strong. Finally, strong growth of international markets reflects the continued broad-based expansion of our portfolio globally.

We move on to Slide 9, on the P&L. We're pleased to report double-digit growth across net revenue, EBITDA and adjusted net income. If we look down the P&L, at the increases in operating expenses, SG&A increase is the investments to support Isturisa and the integration of Enjaymo. R&D is mainly driven by the amortization of Enjaymo as well as medical investments in the Rare Disease businesses. And other expenses are mainly driven by a one-off expense related to Urorec, costs for optimizing our commercial organization in SPC and a minor Q4 impact from the liquidation of our Rare Disease subsidiary in China following the denial of Isturisa's inclusion in the National Reimbursement Drug List.

Importantly, our EBITDA margin reached 37.8%, driven by strong operating performance across both business units and despite significant foreign exchange headwinds. Overall, we're very pleased with this year's financial performance and with our continued track record of consistently delivering on our targets.

Now if we turn to cash flow, we delivered another strong year of cash generation with free cash flow of EUR 559 million, up EUR 24 million versus last year. This was driven by solid EBITDA performance, but partially offset by an intentional increase in working capital to continue building U.S. inventory. With this effort, we are now covered for the majority of 2026 sales. And with the uncertainty around potential tariff implementation, we are proactively securing additional stock there. We closed the year with leverage just below 2.1x net debt to EBITDA, reflecting both the increased inventory levels and the continued share repurchase activity during the year.

So if we now move on to Slide 11, our guidance for 2026. We expect revenue in the range of EUR 2.73 billion to EUR 2.8 billion. For Rare Diseases, we expect high-teen organic growth at constant exchange rate, driven primarily by the continued acceleration of Isturisa patient uptake in the U.S., but also by continued strong performance of other key growth drivers in endocrinology and hemo oncology. For SPC, we expect low single-digit organic growth at constant exchange rates, reflecting some of the 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 2027.

We note that our net revenue guidance is significantly affected by the projected FX rates. We are estimating an approximately negative 3.5% impact, driven mostly by the U.S. dollar, given the external bank consensus view of an average of around USD 1.20 to the euro for 2026. For EBITDA, we expect a range of EUR 995 million to EUR 1.30 billion, including the investments behind the Isturisa opportunity in the U.S. and the FX headwinds of around 4%. This still leads us with sector-leading margins of approximately 36.5% for the year.

And for adjusted net income, we expect a range of EUR 655 million to EUR 685 million, with a margin of approximately 24%. For 2027, our targets remain unchanged, with strong organic growth expected to be complemented by ongoing BD and M&A, despite facing currency headwinds. And with that, I will turn the call back over to Rob for some closing remarks.

Thanks, Mike. So to summarize, our equity story remains clear and unchanged, and I believe we are exceptionally well positioned for continued success. First, we continue to drive strong organic growth across our diversified portfolio with excellent momentum in Rare Disease and a solid contribution from Specialty and Primary Care to our growth. We consistently deliver sector-leading profitability, maintaining both high margins and a very disciplined cost management across the business. We are focused on pursuing targeted pipeline opportunities, advancing life cycle management programs and strengthening our R&D engine, but also delivering meaningful innovation in areas where we can lead.

And then we have a very disciplined capital allocation framework that remains unchanged. This includes progressive dividend policy and the financial flexibility to pursue selective bolt-on M&A while maintaining balance sheet strength. M&A remains crucial to what we have been doing and will continue to be important in '26. Underlying all of this is a business that generates strong and reliable cash flow. This gives us the strategic flexibility and positions us well to capture future opportunities.

And then finally, as this year we mark our 100th anniversary, we are extremely proud of the heritage and strength of our business. This milestone reflects a century of consistent execution, a resilient business model and strong relationships with the medical community. Looking ahead, we will continue to build upon our solid foundation of delivering disciplined growth and achieving operational excellence to support the next 100 years of growth and success.

Now together with the team, we're very happy to take your questions.

[Operator Instructions] First question is from Sophia Graeff Buhl Nielsen, JPMorgan.

Firstly, just on Isturisa. Could you give any further color on the proportion of patient adds you're seeing coming specifically from Cushing's syndrome following the label expansion? Particularly what proportion might already be coming from that non-overt patient population, and how you expect this mix to develop in 2026 and beyond?

And then I think we're also waiting your go/no-go decision for Enjaymo in ITP by the end of this quarter. Maybe you could give us some insight into your latest considerations on this. And what would be the next steps and time lines in the event of a positive decision?

Sophia, Scott Pescatore. I'm happy to take the question on Isturisa. So it's a very important question, and I'm glad that you asked it because the market split is still heavily weighted towards the overt population. And this is something that, as much as we talk about the opportunity in non-overt, that's an opportunity that the market is still in its immature phase and needs development and focus. So the majority of our patients that we'll see this year and into the foreseeable future will come from the overt split.

If your question is around the difference between Cushing's disease and Cushing's syndrome patients, I mean, we have a majority of the patients that are Cushing's syndrome patients post the label update that we had in April last year. But we're seeing more and more non-overt patients that are coming on therapy post-label update. And the split is somewhere around 80/20, 15%/85%. So it's a majority of them are the non-overt patients versus the overt. But as you had asked, that population will continue to evolve. And certainly, that split will continue to grow more in favor of the non-overt population as that patient pool population grows.

It's heavily dependent upon the factors that I had mentioned and the investment that we're making, of course, the education, the diagnosis, the awareness of these patients, the benefits of treatment, and then, of course, the referrals of getting them into the endocrinologists, all take a bit of time, but that will be the evolution of the market over time.

Milan Zdravkovic. I'll try to answer your question around ITP. So the basis for the ITP discussion that we are having, as you can say, very, very strong Phase I data in highly treatment-resistant patients, where we saw very strong response rates also on platelet counts with, you can say, an ability to address a potentially very significant unmet medical need. On the strength of those data, in addition to, you can say, the already existing experience within the cat indication, we had a very encouraging meeting with the FDA, essentially being able to agree on a single Phase III trial to potentially allow for a registrational pathway. Now we are putting the last hands, you can say, on the business case, and on the strength of that, we will take a decision in Q1, which we are well on track to delivering on.

Next question is from Shan Hama, Jefferies.

Just 2 from me, please. Could you perhaps speak to the main pushes and pulls to the guide, as in what factors could drive you more towards the lower end and the higher end of the revs and EBITDA ranges? That's my first question. And then my second question is, for Signifor in PBH, how easy or difficult is it to penetrate this patient population, particularly given there are currently no approved treatments to my knowledge?

Yes. Thanks, Shan. So I'll take the first one on pushes and pulls. So of course, in revenue, we need to ramp up Isturisa. That will be one of the things that we'll be looking at very closely. We also have currency impacts. We've tried to model what we think is a reasonable consensus, but last year, we saw that can go one way or the other.

In terms of the EBITDA, it's really going to be around that mix between Rare Disease and SPCs. So the strength of those 2 businesses are slightly different in margins. So depending on which one is doing better or less well, that will affect the mix. And of course, we can always potentially add M&A if something comes along. We are looking at different opportunities. But too early to put anything in the mix there.

And then maybe I'll start on the Signifor PBH question, and then hand over to Milan for additional commentary. I mean, this is a market that there's clearly an unmet need for treatment of patients that are coming out of bariatric surgery that have hypoglycemia. A large majority of those patients that have bariatric surgery suffer from hypoglycemia. We know that we have some existing data in this space, and as you know, we're working on the Phase 2 at the moment. But this market continues to evolve. Patients that are going into bariatric surgery continues to rise.

We're targeting countries that have the highest rates of bariatric surgery, which would be the U.S., which would be Brazil, which would be some countries in Europe, like Germany. And this market, we see a tremendous amount of potential there. Now the guidance that we've already given, I think several calls ago, which is about EUR 150 million peak year for the PBH indication, we still believe in that market space as we continue to develop the trials. Maybe I'll hand over to Milan for additional insight.

Yes. No, I think it's clear that the obesity market has been evolving. I think there is, to Scott's point, a very significant unmet medical need in patients that develop hypoglycemia after bariatric surgery. We are focusing on the more severe forms of hypoglycemia, so-called Level 2 and Level 3. I think we have seen encouraging enrollment into our clinical trial once we got it going.

And I think one way or the other, I guess, the interesting aspect here is that you somehow need to start with those that have had bariatric surgery and you don't need to, you can say, to [ carpet canvas ] everyone. So I think we're encouraged by this opportunity. We look forward to seeing the Phase II data, and on the strength of that, we will take a decision. But we're very much driven by the unmet need in this disease.

Next question is from Niccolo Storer, Kepler Cheuvreux.

The first one is on Isturisa. We have had the news of a potential competing drug being knocked out by the FDA. And so how has this changed your assessment on the Isturisa opportunity in the U.S.? Second one is on -- again, on Isturisa in China, I guess, this is not moving much the needle in terms of targets. Can you confirm that?

And the last one is about the agreement with Moderna. If you can share more colors in particular about the role that you're going to play from now up to the approval of this new drug. And also if you can give us some insights about expected peak sales and margins thereafter.

Thanks for your 3 questions, Niccolo. On Isturisa, I'll ask Scott afterwards to give a little bit more color. But on your question on China, it's -- following the decision of the lack of national reimbursement in China, we didn't see the right conditions going there to pursue and continue to, in essence, invest in a market with a little -- very little expectancy of a good return. We continue to help Chinese patients and want to help patients anywhere in the world. But financially and business-wise, this was, for us, not the right thing to continue to invest, where we have this big opportunity for Isturisa in the U.S. where we are really putting our investments behind.

And yes, you're right to assume that the EUR 1.2 billion peak year sales did already include the fact that we would not be commercializing in China. So it doesn't alter our outlook there. On Moderna, we are very happy with this deal, and I think also in a way that we negotiated it so that Moderna will continue to do the clinical development and bring this product. If the clinical trial Phase III is -- where the data are expected end of this year, if the results are positive, we would continue to pursue a registration for this product initially in the U.S., but also globally, it remains really an important product.

And then we will do the global commercialization, which means that for -- in terms of impact on the EBITDA, for instance, in '26, we expect basically none. And it should really help us to start generating, if successful and data are positive, revenues from early '28 onwards. So that's something that we're excited about. There's a huge unmet medical need, and we will position to have field force in the market and know the space really well. So we see this as a fantastic strategic fit, and an important partnership with a company like Moderna where we are quite proud to be able to take this product, if successful in clinical development, to market, right? So maybe, Scott, do you want to give a little bit of extra color also on Isturisa?

Sure. Thanks, Rob. So I can't comment directly on what Corcept's strategy is post the CRL. But what I can tell you is that our own strategy, we're very confident in the strategy. We're very confident in the numbers that we already communicated. We already see that in the uptake and in some of the commentary we already made around the non-overt segment. We're also confident that, that market is still a market where there's tremendous opportunity moving forward. We had many conversations with external physicians around this opportunity post the CRL and they remain very, very bullish in their approach to this, and they see a lot of benefit for the use of Isturisa in non-overt patients.

Certainly, we need to continue to educate and develop that market, as I had mentioned. But we remain very confident and positive towards the strategy that we have in place, the investments that we're making and our peak year guidance. I think if anything, on the back of the CRL, we see positive benefit to that. But nothing that would allow us to change our guidance at this point.

Next question is from Charles Pitman-King, Barclays.

Firstly, just coming back on the mRNA-3927, just wonder if I could push you a little bit more in giving us a few more steering points on how large you think this asset could be. I mean you kind of highlighted a huge unmet medical need. But what are you assuming the addressable patient population is as far as kind of the modeling that we should be looking out for this asset?

And then just secondly, on Isturisa, I'm just wondering if you could give us a bit more detail on the titration that you're seeing in the market. I mean, what level are patients typically reaching on average within that kind of 2 to 7 mg range? Or how many patients are you seeing titrate to higher levels than that and how long is it typically taking them? Maybe if I could just sneak in a little third one up for Turkey. You kind of mentioned the slightly later pricing negotiation coming in January this year. Are you expecting a further price negotiation in '26 for Turkey?

Alberto, you might want to comment on Vazkepa and also Turkey?

Sorry, on Turkey, I mean, it's essentially not a price negotiation, is Ministry of Health granting price increases for all companies. As you probably know, during 2025, there were no price increases in Turkey and that has led to our Turkish business in SPC to decline in euros despite relevant volume growth of 10% last year. And we saw a decision from the health authorities to increase prices on an average of 17% in January. And we are waiting to see whether there would be further increases, but this is not confirmed at this stage. We certainly lobby with all other pharmaceutical industries in the country, but that is not within our control. I didn't get the question on Vazkepa, there wasn't a question on Vazkepa. It was on Isturisa as far as I know.

Charles, it's Scott. Maybe I can provide a bit more color on the dosing strategy for Isturisa. It's a little bit tough to tell you on average how the patients titrate. But what we know that in the U.S., I mean, they follow the label, which is to start at 2 milligrams per day, and then dose-titrate, if appropriate, every 2 weeks thereafter. So what we're seeing now is our patients that have been on the product for quite some time that continue to dose-titrate up to levels that we're seeing now on average with the overt population in the 6-milligram per day range.

As we mentioned in the previous call around the peak year guidance, for the non-overt population, that there's a much lower dose needed for those patients, and they start at a lower dose and then the titration period takes a bit longer there. So you see a slightly lower value of those patients in the short term. but more of them in the longer term. So that's why it's a bit of a mix that you'll see moving forward in terms of net patient uptake and in terms of the value of those patients.

I think one of the other points was around how many high-dose patients we have. I mean that's something I can't comment specifically on the number of high-dose patients that we have, but we typically carry a fairly decent number of higher dose patients, which are those we consider high dose to be more than 20 milligrams per day. But again, those patients are usually much more fragile, tend to be much more severe disease and don't tend to stay on product as long as the less severe patients do.

On Moderna, so just to give you a bit more color, I mean, we can't provide, again, peak year sales at the moment. But we can tell you that this is a very, very rare disease and the ratio of patients in the U.S. is about 0.5 to 1 per 100,000. So you can tell that there's very few patients there that have this. It's akin to our Carbaglu business that we've seen. And it's a little bit also hard for us to comment specifically on where we see the peak year at the moment because, A, we don't have the data; and B, we have to go through the pricing negotiation both in the U.S. and ex-U.S. And before we know, specifically what the pricing is, it's a bit hard for us to comment on exactly where we see the peak here at this point.

Next question is from Martino De Ambroggi, Equita.

The first question is on '27 targets that you are confirming. Very straight question, are they achievable under the current perimeter and the current ForEx environment, at least at the low end? And if I understand correctly, no Moderna impact positive or probably negative in case of costs included in 2027 figures? This is my first question.

Martino, we have a very good momentum. And what we didn't -- when we shared the '27 targets in April of last year, we didn't yet factor in any uptake on the increased opportunity in specifically Isturisa in the U.S. with the increased label to Cushing's syndrome. We see very good traction there, and we will definitely -- we expected in '27 we will end at the very high end or above the targets for the endocrinology with this. So we are in a good position to deliver on our '27. Of course, it's very difficult to predict what the currency will be. But from our current in-market performance and momentum across the business, we feel that we're very well on our way to achieve on the '27 targets.

These targets did factor in a little bit of BD, and we're also very actively pursuing a number of opportunities there. But the organic momentum behind it is actually even a bit better than what we would have expected. And we shared, currency is not within our control. And what we also -- just to remind you, for the '27 targets, we also explicitly in April of last year, made it clear that we did not factor in anything like the Most Favored Nation pricing or tariffs as those things were and remain unclear, frankly, for the U.S. Moderna will not impact '27, you're right. I can confirm that.

Okay. And the second question is specifically on price assumption in your guidance, because I clearly understand Turkey is unpredictable, but there is, let's say, delayed possibility to revise upward prices. But specifically for the U.S., are you implementing any price adjustment or any strategy in order to offset the devaluation of the dollar?

Well, we definitely continue to look at opportunities in the U.S. in terms of pricing, monitoring what our competitors are doing and making sure that our products are not only the right medical solution but also economically attractive, but continue to also be fair priced, right? So that's what we monitor and we keep doing that. So it's something that whenever feasible, possible and needed, we -- and we feel that it's a responsible thing to do, we adjust our prices to -- you can do that without any implications on additional discounts in terms of gross-to-net as long as you stay in the inflation range basically. And sometimes we do it beyond.

As a rule, we have not been the most aggressive pricing company in the market. As a rule, we've been known to bring fantastic quality products for a fair price. And that's not something I want to change in this current environment. But we look at every opportunity and be guided more by what the market is showing us and competitors are doing and the need than anything else.

Okay. So overall, there is a positive impact in any case on prices, specifically for the U.S. market, let's say?

No. The currency impact will probably be greater than the net price impact we'll get in the U.S. So I mean we're talking about 3.5% on top of the currency, and a big chunk of that is coming out of the U.S. And in our U.S. business, we won't be able to fully offset that with pricing.

Okay. And very last one, Isturisa. Am I right in modeling Isturisa this year up at least EUR 80 million, EUR 90 million in terms of sales?

We have not been giving this sort of -- I think we share your optimism, but I'm not going to specify any number. There are competitive reasons not to do this. But Isturisa is performing extremely well, very happy with the momentum. And that's as far as I can go. Sorry for that, Martino.

Next question is from Natalia Webster, RBC.

First question on Specialty and Primary Care. You talked about continued decline in reference markets. Are you able to provide a bit more color on the market outlook and how you expect this to progress into 2026 and over the midterm? And also specifically, if you're expecting further headwinds from cough and cold into Q1? And then any color around what you see as the key drivers behind the return from low single digit to mid-single digit sales growth in 2027, would be helpful.

Secondly, just on 2026 costs, I appreciate that your margin guide reflects the additional Isturisa investments, but are you able to talk more around the efficiency initiatives that you're expecting to contribute to next year?

Sorry, Natalia, acoustically it's very difficult to -- completely. So I'll ask Alberto to answer. But maybe also if it's not exactly the question you have been asking, please let us know because it's been difficult to hear you very well.

Natalia, this is Alberto from SPC. I mean I understand that you asked about the reference markets and our ability to get back to mid-single-digit growth in 2027. What I can reassure you is about the strong in-market performance across our core therapeutic areas. We see a strong in-market performance in urology and in cardiology. Yes, there might be some temporary headwinds, sometimes one-off, sometimes more sustained either on ForEx or on stocks. But clearly, we see resilience performance that should enable us to get back close to that mid-single-digit performance in 2027.

You also mentioned about cough and cold. Cough and cold, we are particularly exposed in certain markets. It's not all over SPC. It's mostly concentrated in countries like Russia where the seasonality has been less than in prior years and we are seeing also not very strong seasonality early in 2026. But we are confident that the decline that we saw sustained through 2025 will stabilize more into 2026.

And then the last question, I think, or the beginning, was around the reference market. And as I mentioned before, we focus very much on our promoted portfolio, and we see there a strong performance. But what we have noted is a certain slowdown in the markets over the past couple of years after COVID rebound, moving more from 5% to 6% growth to more like 3% to 4% growth of the reference market.

We are still expecting to be able to outperform or be somewhere, as a total portfolio, in line with that. And we're also seeing that late in 2025, there was some recovery of this slowdown. This is more pronounced in certain markets, that's a slowdown of the growth, like Italy or France. But overall, let's say, it's resilient, but that obviously is in our large and complex portfolio. The influence of the market acceleration is still relevant and noticeable. Hopefully that answered your questions.

And I'll take the 2026 efficiency. So we will see the increased investment behind Isturisa. We'll also see, of course, inflation hitting many of the other line items and labor cost increases. But some of that will be offset by the efficiencies and the optimizations we've done in SPC and other places. So not the full amount of the new investments all hits the bottom line, but we do have, of course, increased distribution costs because of the growing sales and some other things. So overall, that's all factored into the guidance.

Next question is from Isacco Brambilla, Mediobanca.

Thanks for the efforts in providing high degree of granularity in your 2026 outlook. This is much appreciated. I have 2 follow-ups on the building blocks of the margin outlook. First, how do you see gross margin evolving directionally speaking in 2026? I mean, Rare Diseases are visibly outperforming, but we have been running with gross margin below 2022, 2023, and this is a bit counterintuitive.

Second question, again on cost. Should we think this 13% R&D on sales as the new normal for Recordati? Or should we look at this sort of level at least in terms of incidence of revenues?

Isacco, maybe start with the R&D expenditure. So we really invest behind opportunities and when the opportunities are there and they make business sense and we also strive to maintain our high margins overall as a company, right? And when the risk is right, we will invest. So I don't think we put ourselves a target, if you like, we will never go above 5% or 7% or whatever percent. But you've seen that, in terms of percentage, we've actually not been increasing our R&D expenses over the last year as much. In absolute terms, yes, but also on the back of a strongly growing business per se in terms of net revenue.

And we continue to be committed to do targeted investments that generate value for patients and for us. And we will not start to do discovery or very high-risk R&D. So I think that what we currently have is a good like reference. But let's also not forget that we have a little bit of an impact on the cost side, and that helps in that sense, from the currency. So I don't know how the currency will evolve in '27 and the years going forward, right? I don't want to predict that. But I hope that answers your question, and maybe, Mike, you want to...

Yes, let me take the gross margin. And the gross margin, I would expect it to be relatively similar to 2025. We do have growing Rare Disease business, but that's the one getting hit by currency. So all those things will factor into a gross margin percentage around the same level.

And just to go back on R&D, just remember that a big chunk of what we see in that R&D line is actually amortization of intangibles. The actual cash spend is around 8%, and that's been relatively stable. It's been picking up a little bit, but that's not been the real growth. If you look at the real growth from '24 to '25, it's the amortization of the Enjaymo intangibles. So it's really a noncash charge. That will remain constant from '25 to '26. So hopefully, that helps you with what you're looking at.

[Operator Instructions]

Operator, if there are no further questions, I would like to thank everyone for joining on our call. As you can hear, we are enthusiastic about what we've achieved and proud of our achievements in '25. We have a really nice momentum going into '26 with exciting opportunities in both businesses, but extremely clear on the Isturisa side in the Rare Disease. We're well on track to deliver for our targets for this year and for next year and continue to be focused on delivering profitable growth. So look forward to interacting with you on our next call. Thank you all, and have a wonderful day.

Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.

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.

And it's synergistic with the target audience that we already target. So it's not that -- it's a bolt-on rather than anything else. So that's making sense to us.

And then on one of your other updates that we'll be expecting your Phase II in PBH for Signafor. I think you mentioned before it can double your peak sales opportunity here. What would give you confidence in the Phase II to move forward with development of this asset? What would the pathway look like for development? And are there other indications that you're considering for Signafor?

Sure. No. I mean so the PBH, I mean, the Phase II, I can't really speculate on what the readout looks like. I mean that's going to come in the -- the first part of this year. So we're looking forward to what that looks like.

Of course, we've had a partnership with the FDA throughout the development of this indication. So we'll go back and we'll obviously share the results with the panel and understand if we need to move into Phase III or if the Phase II data is relevant enough for us to continue the pathway just based on the Phase II results.

And that's something that we can't really comment on right now because we haven't seen the results, and we don't know what that looks like, and we certainly have to liaise with the FDA on that. But PBH, again, it remains a very exciting opportunity for us. That market is quite fluid and dynamic, and we're looking forward to bringing that product forward as quickly as we can to get that to market for patients that do suffer from the hyperglycemia post-bariatric surgery.

I'm sorry, what was the second part of your question, you were asking about?

Other indications for Signifor as well?

Other indications for Signafor? That's basically what we're focused on, on Signafor. And by the way, that's not our long-acting formulation. That's our subcutaneous formulation that we're developing for PBH. So the long-acting will continue to focus primarily on acromegaly.

But in a different dosing and device then for the acromegaly. So it's a different product.

That makes sense. And we've seen continued very strong growth from your hemo onco and endocrinology portions of the rare disease business. How are you thinking about the growth outlook for metabolic? I think it's stabilized and perhaps we could see returning to higher levels of growth. How are you thinking about that in terms of geographic expansion or product additions?

No. I mean -- so we're very fortunate that it looks like saw from the numbers that Rob showed and the remainder of '25 that we did have a bit of growth in that portfolio. That's not a growing portfolio for us in general because it's a set of older products.

And obviously, with the loss of exclusivity of Carbaglu, we do suffer a bit on the price or the volume is doing well. We continue to put resources behind it to maximize the potential of that portfolio. We don't expect it to be a growth driver for us. I think the best that we really hope for is to be flat year-on-year.

So -- but as -- if we can grow it, and we do see good uptake with Panhematin in that portfolio. we do see, as Rob mentioned, we've seen new patients come on Carbaglu despite the fact that the price has been adjusted, so we're doing really well there. System drops as well for us.

Juxtapid in Japan is doing well for us. So the portfolio as a whole is performing quite well. What we need to see for growth there is probably like a BD opportunity. It would be nice to reinforce the metabolic portfolio, but that's something is that separate from the organic numbers.

Maybe just thinking about SPC, positive news in terms of the price increases in Turkey that you've mentioned, I think you flagged ongoing FX headwinds. Another headwind into '26 that you had mentioned was just a level of stocking in Italy. How should we think about the magnitude of this into this year?

Turkey, we were delighted that '25 was an exceptional year in the sense that there was no correction for the devaluation and inflation that happened in Turkey. There was no price increase for any company whatsoever. But the year '26, we started with 17%. So that's very positive. And there is a potential that during the year, we could actually see another small price increase, but this helps us. We are one of the better-performing companies in Turkey with a unit growth that is quite impressive. Cardiovascular, we see that most of the markets, we had a bit of a decline of our reference markets in '25 coming out of COVID, probably you've seen that. But frankly, also in Italy, you start to see a turnaround there. That market decline has led to some overstocking in Italy, where we had higher stock levels at wholesalers than we would wanted to have. We will have normalized that by the end of this year. So that's all looking good. And the fundamentals for our SPC business remain very strong. It's a very focused organization, has been outperforming the reference markets and continues to outperform. And yes, there has been this little setback of the loss of one of the products in Italy, but then we are complementing that with Vazkepa. And frankly, if you look back at the last 15 years or so, this has always been the case in the SPC business. And that's one where we need to replenish, but not necessarily we're making very big acquisitions, but in essence, keep feeding the diesel engine with enough to continue to grow this low single-digit growth at very high margins, and we're confident that we can do that. OTC is a specific part. It's always reacting a little different from the rest. We are in a couple of countries in Europe. We don't have pan-European brands, but are in small niches. But pasireotide is also growing quite nicely, faster than the prescription part at the moment and also with similar margins, which is quite unique for a European OTC business. So all in all, this is a very strong and well-performing business that will continue to deliver and beyond '26 is positioned to really do well.

And I think with that, I can maybe squeeze in one more question, which is just what is Recordati's current appetite for BD, given I think you're at the upper end of your midterm target leverage ratio?

I think our appetite is healthy. We will maintain our discipline, right? And I think everyone that looks around in the world sees how uncertain the world is the volatility. Some of the prices for assets out there, I think, are a bit high, but good assets has always been -- have always been expensive. And we've always managed to really turn that into a really good return on capital invested.

So we continue to work on it. We actually have fairly substantial number of active deals ongoing where we're in negotiation. I'm confident you never know how those things end, but I'm confident that we're well positioned to land some of them, but we will maintain our discipline on both the debt level that we take and on the opportunities. With the organic growth opportunities in rare disease, we're under no pressure to do a deal. So we can afford to be as selective as we need to be and keep the discipline.

Thank you so much. With that, we're out of time. Thanks for your time.

Thank you.

Thank you.

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Recordati 9 Months 2025 Results Conference Call. [Operator Instructions].

At this time, I would like to turn the conference over to Mrs. Eugenia Litz of Recordati, Investor Relator. Please go ahead, madam.

Thank you, and good afternoon, everyone. I'm pleased to be here today with Rob Koremans, our CEO; and Luigi La Corte, our CFO, who will present results for the first 9 months of 2025. Then Scott Pescatore, Executive Vice President of Rare Diseases, will provide further insight into the exciting Isturisa opportunity. Also joining for the Q&A session will be Alberto Martinez, Executive Vice President of Specialty and Primary Care; and Milan Zdravkovic, Executive Vice President of R&D. As always, the presentation is available in the Investors section of our website.

It is now my pleasure to pass the call over to Rob. Please go ahead.

Thank you, Eugenia, and thank you for joining us today. The agenda is a little different from what you've seen in typically quarterly calls. You've all seen the exciting news that we brought out on the peak year sales opportunity with Isturisa. And we wanted to give you a little bit more color on that. So Scott is going to do that in just a little while. And as this additional investments behind the opportunity of Isturisa will impact the margins in 2026 specifically, we'd like to also give you a little bit more of an update on the outlook, which is also a separate part here in the presentation.

But let me just start with the first 9 months of this year. And we're delighted that once again, we've really got very good results for the first 9 months of 2025. Beginning with the net revenue of EUR 1.960 billion, an increase of 12.2% compared to the previous year or 8.1% on a like-for-like and constant exchange rate base with very good momentum across SPC and a step-up in growth of rare disease, and an adverse impact of the currency of 2% year-to-date, mostly coming from the U.S. dollars and the Turkish lira.

EBITDA was EUR 743.9 million, up 11.8% versus prior year, with margin at 38% of net revenues. Adjusted net income was EUR 493.1 million, up 10.7% from the previous year. And the net income was down by 3.6% from the previous year, reflecting also a one-off provision of EUR 14.1 million, which Luigi will talk about a bit further down in the presentation.

As for R&D, I'm very pleased to highlight that in line with plan, enrollment was completed in the pasireotide Phase II trial for PBH, and we had a very productive meeting with the FDA to define the potential U.S. regulatory pathway for approval of Qarziba in U.S.

Looking ahead, I'm pleased to say that thanks to our strong business momentum, we deliver results also this year within the guidance range set at the start of the year, albeit in the lower half of the range due to FX headwinds. They are projected at approximately 3% for the full year and are very likely to persist into 2026.

And finally, we are thrilled to update our peak year sales estimates for Isturisa for the fourth time since acquisition. We're confident to double our peak year sales estimate for Isturisa to greater than EUR 1.2 billion, and as we invest actively, target the broader non-overt Cushing's syndrome patient population. We're very, very excited about this opportunity, and Scott will give you some more insights a bit further down in the presentation.

But now let me hand over to Luigi who will take you into more details of our 9 months results.

Thank you, Rob, and good morning, good afternoon, everyone. I'm delighted and somewhat proud to be able to say for the 24th time actually that we have once again delivered a strong set of quarterly results. I'll give, as usual, some additional color to the numbers you've seen on the materials.

And starting with SPC. I know there's a lot of excitement around the prospects on the rare disease side, but very happy to see that especially primary care has also delivered in the first 9 months of the year, a strong performance with -- and continuing to outperform relevant markets with our promoted portfolio, a 5% like-for-like growth at constant exchange rate and around half of that rate, excluding Turkey. This was achieved in the context of relevant markets, which we've seen slightly step down in terms of the rate of growth for a few separate and different reasons. Cough & Cold had a soft Q1, recovered a bit in Q2, but was again soft in Q3. And we -- it seems that we are in for a bit of a soft season into 2026.

Turkey, we have not seen a price increase yet this year. And despite over 30% devaluation in the country, it seems authorities are reverting back to potentially only one round of price increases per year versus two, and a cumulative excess of 100% in previous year.

And in Italy, there's been a general softening of market growth. You remember, we said coming into '25, we felt the stock levels were a little bit higher in the market, and that softening has allowed us to absorb that, and we'll start doing that a little bit more in Q4 and as we get into 2026. But despite that, very pleased to see all of our core franchises growing nicely, driven by a number of products that you see highlighted on the page across both Rx and OTC and delighted also with the transition on Vazkepa, which is starting to contribute, obviously, but -- which will ramp up as expected in 2026 and will offset the unfortunate loss of Cardicor, the license for which will not be renewed at its expiry in early 2026. It's a local product that we market in Italy with a run rate of around EUR 35 million per year in terms of revenue.

These are some of these headwinds that I mentioned on SPC, together with Cardicor will mean SPC realistically will grow at low single digit in 2026, but we do expect it to return to a mid-single-digit growth in '27.

As regards to rare disease on Slide 5, clearly, a very, very strong performance and accelerating in Q3. Constant exchange rate growth on a like-for-like basis of 14%, slightly up versus year-to-date at the half of year. Scott will talk about Isturisa. So I'll just touch on the other ones, on the other key franchises and very simply say, we're continued to be very happy with each of Signifor, Qarziba and Sylvant are growing at double digit and really across geographies.

And Enjaymo, despite the summer months being usually slightly softer, posting close to 25% increase on a pro forma basis versus 2024. So very, very strong momentum across all of the key growth franchises, combined with the metabolic that continues to be resilient and in fact, continuing to show growth, which is net obviously of increasing headwinds on FX on the U.S. dollar.

We do feel really great about the long-term growth opportunity in rare disease, for what is one of the broadest portfolios in rare disease across the industry.

Very briefly on Slide 6, on revenue by geography. Once again, very pleased, all regions really are contributing to that momentum. The U.S. is now close to 20% of total revenue and growing in local currency by over 30% and accelerating on the back, obviously, of the momentum, particularly behind the endo franchise and of course, the contribution of Enjaymo, which is also contributing to the strong growth in both Germany and the international markets. You'll see very much in line with expectations, the more established markets in Europe, growing at single-digit rates with, on the other hand, Russia and other Central and Eastern European markets growing strongly at double digit on the back of both volume growth and selective price increases.

I'd like to also call out Turkey, which, yes, is being challenged by the high devaluation and the lack of price increases this year, but is continuing to grow double digit and really outperforming the local market in those terms. So very happy with the revenue performance, both looked at from a product lens and geographic one.

When it comes to the P&L on Slide 7, very pleased with this double-digit growth at the level of both revenue, EBITDA and adjusted net income. And also very pleased with adjusted gross profit continuing to creep upwards on the back of the changing mix and very solidly above the 70% mark. Operating expenses are very much in terms of percent of revenue in line with Q2 with a step-up versus '24, reflecting the investments we started to make behind Isturisa, in particular Enjaymo, and which we do expect now to step up, as Rob has mentioned.

We did have an unfortunate and unexpected setback in an ongoing litigation that we had with Italian Pharma Agency, which took the view that we should have continued to play a clawback on Urorec even following the minus 40% price reduction, which we incurred in 2020 when the product lost exclusivity. The company considered that request to be absolutely ungrounded, and we still consider it as such. But unfortunately, in the context of budget pressures, the administrative courts ruled against us as they did also against other pharma companies in the countries engaged in similar litigation, and we've taken a provision to cover the cost of that is unfortunate, but really a one-off.

But notwithstanding that, very strong results, very pleased with the outcome. And you recall, we said from the start of the year that we expected our Q4 margins to be as usual, lower than the first part of the year, but to be above 2024 levels. And so with these results and with that in mind, we're well on track to deliver on the margin objective that we set for 2025.

And finally, on my side, as you'll see from Slide 8, we've always on this call also talked about our strong underlying cash flow performance, and that remains true. In this first 9 months, we took deliberate decision to increase our stock levels and particularly in the U.S., EUR 95 million roughly of that EUR 138 million increase in working capital is due to that, which -- with that increase now covering almost 1 year worth of shipments into the U.S. So we're very pleased with that. But of course, with that and also the higher spend on net share buybacks, we now expect leverage at the end of 2025 to be around the current level, so just above 2x leverage.

So once again, very happy with the results. But with that, I will now turn it over to Scott to talk about the exciting opportunity that we see on Isturisa going forward.

Thank you, Rob. Thank you, Luigi. This is Scott Pescatore, and it's a real pleasure to be here today to provide a bit more color on this exciting opportunity that we have with Isturisa. But before I go there, I'd just like to start off with just a brief update on the current performance of Isturisa on Slide 9.

We're seeing quite a robust patient uptake in the U.S. since the FDA expanded our label for Cushing's syndrome back in April of this year. And as you know, the label has expanded our patient pool quite significantly. And the impact is clear from the graph, you can see there. Active patients in the U.S. have more than doubled versus previous year to over 1,200 in quarter 3, which is quite a nice increase versus quarter 2. And importantly, this growth isn't just about new starts, new patient starts. The patients continue to titrate up to optimal doses, which is also accelerating our revenue.

But equally as important, the expanded indication is broadening our ability to reach more patients, and we're just at the beginning of tapping into this full market potential. There's quite a bit of potential that remains in the Cushing's syndrome market, and I'll describe that in a bit more detail on Slide 10.

So if we focus on the right-hand part of the slide, the U.S. Cushing's market offers a substantial room for growth, especially among what's called -- so-called non-overt or mild Cushing's syndrome patients. Non-overt mild patients are typically those patients who present with cardiometabolic comorbidities such as persistent and difficult-to-treat hypertension and/or diabetes, and their cortisol levels tend to be in the range of about 1 to 2x upper limit of normal. These patients are most commonly treated by community endocrinologists, select cardiologists and primary care physicians.

And with regards to the dose, we can expect the dose in these patients to be slightly lower than that of overt patients, but that's based primarily on the severity of the disease. And if we look at the addressable patient population, there's significant upside opportunity here within this group of patients potentially exceeding more than 30,000 at peak. But by expanding screening, diagnosis and education, particularly in the community settings, we're well positioned to capture this broader patient base and continue to drive long-term growth of the brand.

If we move to Slide 11. Clearly, you can see that we're raising our ambitions. Our peak year sales target for Isturisa is now more than doubled to greater than EUR 1.2 billion, reflecting our confidence in reaching more non-overt Cushing's patients.

So how are we going to achieve this? We're investing approximately EUR 40 million to EUR 50 million annually on things like expanding our U.S. sales, our U.S. field force in the U.S., our medical science liaisons, generating real-world evidence and conducting a Phase IV randomized controlled trial. Now just to remember that the study population in this trial is already within our approved indication, but the objective of the trial is to give physicians additional data on the use of Isturisa in milder patients.

Now these investments are designed to double our peak year sales by continuing to treat not only the mild patients, but the severe Cushing's disease and severe Cushing's syndrome patients, while putting special focus on the non-overt segment that's been underdiagnosed and undertreated. And ultimately, this will allow us to capture approximately 35% of the addressable population at peak.

So the outlook is strong, and we're building the infrastructure to capture and sustain this momentum. We're very excited about the road ahead. And with that, I'd like to turn it back over to Rob.

Thank you, Scott. Looking to the outlook and as mentioned, we anticipate that the robust performance across SPC and Rare Disease will enable us to achieve our full year targets for '25, in line with the original guidance. This comes despite a challenging macroeconomic environment and approximately 3% of currency headwinds expected for the full year, and they're likely to persist into 2026.

If you look ahead for 2026, we expect sustained high double-digit growth of Rare Disease at constant exchange rates with revenues nearing 50% of our total revenues. Isturisa will be a key driver and to fully capture this opportunity, there will be additional investments to target the patients that do not present themselves with all the typical clinical symptoms that you see at Cushing's, but are detected often primarily through persistent hypertension or difficult to treat diabetes. These so-called non-overt Cushing's syndrome patients are a very significant opportunity and the opportunity to tackle them going forward and help them and support them is what we're really excited about. And this underpins our double peak year sales estimates. As a result, 2026 should be an investment year aligned with our updated sales forecast for Isturisa.

For SPC, we expect low single-digit growth at constant exchange rate, which reflects also the loss of the Cardicor license that Luigi mentioned, but the fundamentals of the business remain very strong and intact, and we are confident to return to the mid-single-digit growth in 2027. And for 2027, our targets remain unchanged with strong organic growth expected to be complemented by ongoing BD and M&A.

And finally, we are confident in our long-term growth prospects, supported by the doubling of our peak year estimate sales for Isturisa. And now together with my colleagues here in the room, I'm very happy to turn over to you and take your questions.

[Operator Instructions] The first question is from Shan Hama of Jefferies.

Just 2 from me, please. Happy to take them one at a time. So firstly, given that the midterm guide was reiterated, does that mean the sort of incremental peak sales potential from the non-overt population will likely be realized outside of the midterm period? That's my first question.

Shan, maybe I can take that. I think the line wasn't great. I think the question was, as we are confirming 2027 guidance, does that mean the increase in peak is outside of that planning period? Well, no, the short answer is no. Of course, we expect the ramp up already to be steeper on Isturisa. Of course, as you know, FX have unfortunately moved against us versus when the guidance was set out for 2027. So very happy. And don't forget also that the 2027 guidance does include a contribution of BD and M&A.

So we are confident that we can achieve that guidance up despite the higher FX also on the back of the increased pace of growth that we expect from the Endo franchise. Does that address your question?

Yes, that's perfect. And then just for my second one. Sort of looking to 2026, with the OpEx for Isturisa obviously ramping and Rare Diseases potentially doing better than current Conn's expectations and SPC may be not as strong as where Conn's at the moment, how should we be thinking about the margin trends for next year?

Yes. No, I'm sure many will have the same question. So happy to address that. Look, we're not going to give sort of precise guidance at this point, right? And that's simply because we typically do that, as always, at the beginning of next year, we will be reviewing budget in the coming weeks. We have made the decision to invest behind what we feel is a fantastic opportunity. And obviously, that will weigh on the 2026 margin. I think we've given you some indication of what that kind of looks like. If you take the bottom part of that range of spend, around EUR 40 million, that's 1.5 points roughly of margin.

Of course, the mix improves as we go into next year, but we've got FX going in the opposite direction. So again, we want to make sure we gave you a sense, particularly because of that investment decision that we've taken. But we're going to, as always, give more precise targets for next year once we have discussed the budget with the Board. Is that okay?

The next question is from Sophia Graeff Buhl Nielsen of JPMorgan.

Firstly, just on Isturisa, could you give us any further context on the market research you've done, that's given you confidence in expanding the Isturisa opportunity into the non-overt Cushing's syndrome population. Just what are the competitive dynamics in this market? And how did you arrive at the assumption of capturing 35% share of the U.S. addressable patient population that underpins your new guide? And then also just in terms of some of the headwinds that you've seen this year, including some destocking in Italy, weaker start of the Cough & Cold season and pricing dynamics in Turkey. Can you give us any more color on the magnitude of these impacts and what we should expect for these in Q4 and going into next year?

Maybe I'll start with the second part of the question, and apologies, I couldn't catch the name. So we said that in terms of those headwinds, first of all, again, we're very pleased with the momentum to date across both SPC and Rare Disease. I would expect, as I said, those headwinds translate into an SPC growth rate for next year in the low single digits, rebounding to mid-single digit in 2027.

When it comes to the more detailed questions around the dynamics on the endo side, I'll pass over to Scott. We'll obviously be conscious that it is a competitive field and hence, there's a limit to what we will give away in terms of the research that we may have done.

Thanks, Luigi. Sophia, this is Scott. Thank you for the question. So yes, I mean to answer your question in short, we did significant market research around this opportunity, both internal assessment and using external advisers. I mean, we spoke to many different endocrinologists and different treaters in the field to verify this market space. There are also other players in this space that are also verifying the patient numbers and this market opportunity.

With regards to our market share at peak, I mean, this is a competitive market space. It's been competitive and it will continue to increase in its competition. So we believe that we can be confident in securing at least 1/3 of those patients and then we'll see how things progress as we move forward.

The next question is from Isacco Brambilla of Mediobanca.

I have 3 that should be quite fast ones. The first one is on Isturisa. Considering the new sales target and the commentary around different dosage, the investments behind the product. How should we think regarding the profitability and regime of Isturisa compared to the rest of the Rare Disease portfolio?

Second question is on FX. I know you usually do not give this data, but if you can help us understand the FX headwind on EBITDA this year, so in 9 months 2025, just to have a sort of order of magnitude.

Last one is a more strategic one. Considering next year, Specialty and Primary Care will be a year of softer growth. Could you think to restart your M&A campaign in this space doing maybe something more relevant than Vazkepa that you already closed?

Thanks, Isacco. So I would think Vazkepa is extremely relevant. We indicated for '27 that we could and will achieve EUR 40 million, and that's definitely not the end of the growth for that product. It's an important product for us and for patients, and it fits perfectly into our cardiovascular portfolio. So I'm really happy with that.

I don't think we typically give percentages of profitability and margins on products like Isturisa, but you see that the overall portfolio of Rare Disease has a slightly higher margin than what we have in SPC. And Isturisa is an important contributor of our growth. So it's a product that we believe is really well worth investing into. And this additional investment, and I think we've stressed it, I believe is fairly, first of all, low risk. So we do some clinical work, some medical work and clearly also commercial, but we don't need a new label for this, and we already start seeing patients now with this so-called non-overt, so we're super excited by it, and this is an opportunity that is a bit like launching a new product. It will take time. It will take investments, but that's something that at any time we can always correct and adjust for, right?

So that's something that I feel very, very low investment in terms of the EUR 1.2 billion at least that we can achieve with these revenues. Luigi, do you want to take the middle question?

Yes. On the FX, you are right, Isacco, we don't usually give that sort of level of detail. But I think it's fair to say it's obviously where we say that we have a 3% headwind on the revenue side, you should expect a lower percentage at the EBITDA level. So let's say, around about 2% would probably be the number on the -- at the level of EBITDA.

And as I said, we expect a similar level of headwind when we go into next year, also because, as you know, the U.S. dollar devalued after Q1. So we had one, let's say, a very positive quarter, and then we started to see this devaluation. So we have -- but most are expecting a further devaluation of the dollar next year, but also the full effect of this year. Does that address your question?

The next question is from Charles Pitman-King of Barclays.

Charles Pitman-King from Barclays. Just staying on the theme here. First question, please, just on Isturisa. Just thinking back to kind of 1Q '25 and discussions around when you previously raised peak sales. This was originally driven by an expanded market outlook. And I remember from our conversations that you did not predict further raises peak sales unless there was going to be a significant market development. So I'm just wondering, over the past 5 months, what is it that has -- what is it that you define as a significant market development? And is it just your experience of seeing these non-overt patients that you didn't expect to see previously? Or has something changed that makes you more confident that you can, in fact, change -- create this step change in diagnosis?

And then maybe just if you could give us a little bit more of an idea of what that non-overt Cushing's syndrome patient journey looks like, just so that we can get a bit more of an understanding versus the kind of currently addressed overt Cushing's syndrome patient?

And then just one quick clarification of -- could you give us a little bit more detail on what high double-digit and approaching 50% means? I mean is this kind of just entering the range of 17% to 20% as high teens? And is it approaching just anything above 45%?

Thanks, Charles. So high digits -- high double digits in terms of rare disease would be high teens, double digits. So it's -- and approaching the 50% is approaching the 50%. It's -- you will see we'll be a bit more specific in February, clearly, but we see very good dynamic. And that is also answering to your first.

The dynamics in the Cushing's market and maybe because there's so much more attention to endocrinology in general are quite astonishing. And we had frankly not expected to see the ramp-up in some of these so-called non-overt patients that do not present themselves with clear Cushing's and clinical symptoms, but you pick up through cardiovascular comorbidity. That is going much better than we expected, which prompted us, and we had already, of course, started to do very, very detailed to market research. And like Scott outlined in the U.S., and we actually really see this opportunity.

What also helps is we have colleague companies that work, a company like Corcept that works in the same direction. And then the feedback from doctors in the field has just changed over the last couple of months. From no, I would never consider to, yes, I would absolutely treat. So with that, and there is a fairly vast group of patients well beyond the 30,000 that we indicate of people that have high cortisol and also a comorbidity. And we've been maybe even still quite -- well, we are never known to be very aggressive in our assumptions. We believe that is achievable target -- the target audience of something just over 30,000 and to get 1/3 of those patients towards -- in the coming years.

It's like launching a product, we believe it's highly realistic. And we've validated this from various parts. And now we stand very confident in front of you in that sense, right? So it's an exciting opportunity. And one, it's not what you get every day, an opportunity to almost launch like a new product and value at so low cost and risks. So -- hence, our excitement to share this with you. Does that answer your question?

Yes, it does. Maybe just focusing a little bit on -- if you can give us any detail about the kind of difference in the patient journey. I mean are they [indiscernible] is it on a sliding scale just to [indiscernible]?

I'll let Scott to answer that question.

Thanks, Rob. Charles, it's Scott. So a very good question on the patient journey for these. So first, on your first question on the market development, we are seeing these patients now. I mean we do have uptake of these milder patients within the -- within the patients that you saw on the slides that we presented. But again, as Rob had mentioned, it really prompted us to do a further investigation into this segment and understand what the potential could be and what that looks like over the years and how that's evolving.

But the patient journey is slightly different for these patients. And it's not -- because typically, as I mentioned in the presentation, they're sitting with really 3 subgroups of physicians. One is the endocrinologist, two is the cardiologist and then some of the primary care physicians. And that's based, as Rob had mentioned, on these comorbidities that they present with, which is persistent kind of difficult to treat hypertension and/or diabetes. Patients who have these comorbidities, physicians are now starting to look for reasons why they're not able to treat or control these diseases, and they're looking at cortisol levels as a culprit, prompting more cortisol screening for these patients. And we're finding that more of these patients are actually showing up with this so-called milder form of Cushing's syndrome with their cortisol levels, as I mentioned, which is about 1 to 2x upper limit of normal, which is significantly lower than your overt or severe patients.

So the point is, is that the journey of these patients, if they're not sitting within the endocrinologists and keen endocrinologists will identify them and begin treating them, which is what we're seeing now in our numbers. But there's a big referral pattern that needs to take place from the cardiologists and the PCPs where these patients could be sitting for them to sort of understand their underlying comorbidities, then test them and then refer them on. So the patient journey is slightly longer, which is why we see this opportunity that extends far into the future because there's a market that still needs to develop and get traction. But we do see uptake now. And that uptake as we continue the investment, continue the education, continue to do all the things that we're investing in the clinical trial, raising awareness, we'll get the traction to get these patients referred on from those other treaters to the endocrinologists and then ultimately treated.

The next question is from Niccolò Guido Storer of Kepler.

The first one, again, on high double digit and approaching 50%. Again, I was wondering how you can think of keeping together these 2 things because if for you, high double digit is 18%, 19%, 17%, then Specialty and Primary Care growth is low single digits, you're not going to get to approach 50%. And the other way around, if you're approaching 50%, probably growth in Rare Disease is going to be higher. So again, if you can clarify a bit on that?

Second question on cost associated to Isturisa development. In the press release, you talked about EUR 40 million, EUR 50 million and a gradual ramp up, up to these levels. But if I understand well, we should expect EUR 40 million already for 2026. Is this right or not, at least this is what I got from the previous answer.

And last question just a curiosity on Cardicor loss of license, if you can explain what's behind this, which is something quite uncommon?

Thanks for your questions, Niccolò. Let me start with the last one. It's indeed very uncommon. It was the end of the license. It's -- the product is returning to its originator. And of course, we checked whether we have the similar risk in the rest of our portfolio, and there is no such risk for the next 10 years. Part of our SPC nature of business is you take licenses, and this one, it's -- I mean it's on a full year base, EUR 35 million -- on a EUR 1.5 billion business, of course, not the biggest, but it doesn't help in generating growth for next year. That's why we flag it. For us, more important is looking at is the similar risk present and the answer is no. Luigi, do you want to take some of the questions on the...

No. On the spend for next year, Niccolò, I don't know that we're going to give a lot more than what I said. We said that, yes we started, but we have incremental investments, which will get to EUR 40 million to EUR 50 million. You should expect the number for next year to be closer to the bottom end of that. And as I said, the margin for next year will reflect both that. But on the other hand, on the positive, the shift in mix. But on the other hand, the adverse effects. And I'm not going to give too much more than that at this stage.

With regards -- with regards to the growth rates, you should sort of take the, as we said, high teens for the Rare Disease and approaching -- is approaching, is not getting too. So it's clearly trending in that direction. And hopefully, that addresses your question, Niccolò.

The next question is from Martino De Ambroggi from Equita.

The first question is on the Slide #9, where you present the uptake in acceleration for the patients. Could you just very roughly indicate what was the percentage of new active patients coming from the expansion of indication? First question.

The second is on the peak sales guidance. Could you split in your assumption, what is the overt and non-overt of these peak sales very roughly? And when you mentioned 35% in terms of share of patients, is it the same for overt and non-overt? And could you just very roughly quantify the difference in terms of potential sales of every patient if it's overt or non-overt?

And very last, sorry, on Isturisa, what is the percentage of sales generated in the U.S. in '24, '25 as you prefer?

Martino, I understand some of your questions, but you might appreciate that some of this is really competitive and sensitive information, which we're not going to share. We didn't say 45%, if that came across as a percentage market share is 35%. But -- I mean, we will -- we typically -- I mean, the U.S. is a very important part of our today's sales already. Going forward, would be actually even more important, right, because we see the biggest opportunity for this so-called non-overt patients actually in the U.S. And that is -- it's going to be -- Isturisa U.S. is going to be the major growth driver for Isturisa.

At the moment, we still have mostly Cushing's disease patients on therapy. With the extension of the label, we got some Cushing's syndrome and that was -- that's the first patients coming in from April this year. So it's still a fairly small percentage. And quite frankly, we were positively surprised by the fact that they did present without us actually really promoting so strongly for this type of patients. And that was one of the reasons also to, like Scott said, to really look even deeper into this. But at the moment, the vast, vast, vast majority of our patients and revenues with that comes from the more severe or Cushing's disease patients.

Some more of the detailed information on what is U.S., Europe, how do we split? I'm sorry, we are not going to disclose simply because that's something that might be too sensitive for the market out there.

Next question is from Niall Alexander of Deutsche Bank.

It's Niall Alexander from Deutsche Bank. So first one on Isturisa and the expansion. So given the investment there, does that impact how you guys will be looking at M&A and business development activity going forward? Obviously, it's going to be a great focus on Isturisa. So does the strategy there change? That's the first question.

And then the second one on Qarziba and additional data requests from the FDA. Just wondering how that news could potentially impact the peak guidance that you gave earlier this year. Does it mean it might just take a little bit longer to get to that peak sale estimate? It would be helpful just to get some color there.

Thanks for your questions, Niall. No, if anything -- no, our BD and M&A strategy doesn't change. If anything going forward, Isturisa will help us to fund even better and more deals because it's a really exciting opportunity. But our strategy remains completely unchanged and we will continue to focus both on the SPC side and on rare side and have a couple of really interesting discussions ongoing.

On Qarziba, I think you captured it right, but I'll ask Milan to give a bit more color on it. But the -- it will not change the peak that we guided on. It will take a bit longer to get there. We -- just for a reminder of everyone, we guided EUR 30 million peak year sales for this very restricted and limited group of patients with neuroblastoma. And that potential should really still be there if we get the product registered. And I think Milan is actually more optimistic than before, but I'll pass to him to give some color there.

Thanks, Rob, and thanks for the question. Yes. So as we hinted at also in our 2025 call, we were planning to meet with the FDA once we had the first set of data also to establish, you can say, a potential pathway towards regulatory approval. And we have now had the meeting, and it was a very successful meeting. We shared the data from, you can say, the first data set. FDA wants, you can say, additional data from a second trial, and that trial is already ongoing, and this is what we are guiding towards.

But as I said, we had a very, you can say, encouraging meeting with the FDA, you can say only discussing the data, but also starting to elucidate what should a potential BLA package look like. And I find that very, very encouraging. I think it's clear that Qarziba addresses an unmet medical need in this relapsed/refractory segment of neuroblastoma patients. Also, I think because of the more benign safety profile, in particular, the neurotoxicity in comparison to competition. And this unmet need is also recognized by the FDA. So I think all in all, we are encouraged and we will keep working on potentially getting it approved in the U.S.

The next question is a follow-up of Shan Hama of Jefferies.

Just really quickly, how do you view the sort of current competitive landscape for Cushing's, especially given relacorilant's PDUFA at the end of the year, sort of how do you think that, that will change the market dynamic and what will the shape of the market look like?

I don't want to speculate what happens to an FDA approval or not. But frankly, more companies in this field that help to educate patients, doctors to transfer cardiologists to patients with this persistent, difficult-to-treat hypertension or diabetes or obesity or anything in that field, I think it helps. The education is good. In our estimates, like we said, we believe that we would capture 1/3 of this patient population. Clearly, and we are very well aware that Corcept have started to move into this direction long before we did, but we believe this can actually really help us. And in this case, more companies making sure that these patients are getting diagnosed and transferred and supporting that is a very good and positive thing.

We know that our product has a very strong clinical profile, both in efficacy and safety. So we feel very confident, and this is just also based on today's experience and all the feedback we get from the market that we can capture this market share. But we will need to help and develop this market. And with that, having more companies in the space is going to be a good thing.

Just one other thing to add on top of that because I completely agree with Rob. We can't forget that. I mean, we're talking a lot about these mild or non-overt patients, but the investment and awareness in Cushing's disease and severe Cushing's syndrome is just as important because there are patients there. There's a market there to be supported and any awareness or investment in this market will help the broader population of patients as well. So this is about building the non-overt or the mild population, but it's about supporting and continue to grow the severe overt population as well.

So as Rob said, I mean, I think it's important that there's other players in this space and all the investment is welcome to raise awareness and education.

The next question is a follow-up of Niccolò Storer from Kepler.

Two please. One on peak sales. Should we still think about 2031 as the peak year for Isturisa or should move, let's say, this a little bit further in time? Second question, now you are with this move, focusing 100% on the U.S. Any chance to see a similar move outside the U.S.?

Thanks. So the focus is on the U.S. because that's where really the big opportunity is, but be assured we focus on -- focus, but we push for the rest of the world, and Scott is very much a global player. And our teams are active in the field of endocrinology everywhere. So that's important. But -- and I think that's a reality for almost every single rare disease indication in the world is the real big opportunity will be in the U.S. But we are, for instance, also extremely excited about Japan or getting into Brazil, and we're doing a really half decent job in Europe as well. So it's really a global product and a global effort. The -- sorry, I forgot your first question, sorry, Niccolò.

Was about the peak year sales.

Yes. Maybe this is one of these products that peaks till it doesn't. It's going to take a couple of years. It's very difficult. I think by '31, you will be relatively close to your peak, but there will still be growth, so you cannot technically say peak, right? But it will take definitely some years because it's a bit like launching a product really, getting a new concept in for patients, for doctors, and making sure that these referrals really work. That's something that always takes time. And that I think we have to be realistic about that and that's how we project it as well.

Yes. And maybe, Niccolò, just to build on that because if the question behind the -- you were mentioning 2031 as being the former planning assumption for loss of exclusivity on Isturisa. I'd just like to remind that already in the 3-year plan, we highlighted that we do see the opportunity and growing the confident around that, that this could be extended to 2033 in the U.S. subject to patent term extension. We're also working on a pediatric indication. And there are sort of patents in the Orange Book going out to 2035. And you recall, in Europe, most major markets, the patent term has already been extended to 2035. So I just wanted to make sure that, that was clear given that you sort of mentioned 2031.

Yes, yes. The only thing is that 2033 for the U.S. is still probably a question mark. Am I right?

Well, we're really growing the confident with patents. In front of courts, you can never be 100%, right? But this is really like Luigi said, pediatric indication, we're progressing really well on that, and that's good. And then the PTE is also looking very, very strong and clear. So we're fairly confident on this '33 date.

Next question is from Bruno Permutti of Intesa Sanpaolo.

A question again on Isturisa. The wider population that you are not considering now is also a matter of studies, new clinical studies relating to the balance between benefits and cost of treating milder populations -- also milder population. So I want to understand if there is -- there are some developments on the market that in this sense that make you thinking that it was the right moment to widen the -- and to reach also these kind of patients.

And the second question was relating to the reimbursement. If there will be difference in the reimbursement between milder population treatment and/or severe population treatment, and if you have to change something on that side? And the last one was on tariffs. You said that you have a consistent stock in the U.S. On 2026, how do you see the tariff impact, if you can update on this point also?

Let me start with the, Bruno, with the last question. No, we've been building quite significant stock that goes well into '26, depending on when really and if at all these tariffs come into place. So it's a bit speculative at this point in time. But we feel that for '26, we've done a lot to be able to mitigate the impact. In terms of -- I'll pass to Milan and Scott on this question, but I want to really make sure that current label -- we don't need to do the clinical trial to get a label. We have the label. The trial will help to just get more data and evidence for patients to be able to get treated and doctors to feel comfortable about it. But the current label actually really covers these patients. And we already, like we said, see patients that get treated with this today. It's also not something that depends on the reimbursement. But maybe Scott, Milan, you want to extend a little bit on it?

Yes. Sure. Thanks, Rob. So just very quickly on the reimbursement side. We don't anticipate any additional hurdles in respect to what we do today. First, because this is already within our label within Cushing's syndrome. These patients are diagnosed with Cushing's syndrome, and they're seen by the endocrinologists. So all the 3 sort of areas that we're seeing in severe patients today. So the reimbursement process will remain largely the same for over just expanding the population.

With regards to coming back to your question on -- we discussed it a bit earlier on how we arrived at this opportunity. As Rob had mentioned, we're seeing these patients today. And we -- it prompted us to do additional investigation on the market viability of looking at patients that have a slightly lower cortisol level with comorbidities, as I mentioned, hypertension and diabetes. There's also other players in the market now that have generated some robust Phase III data with patients suffering from comorbidity and having lower levels of cortisol. So those are some of the data points that we use in addition to the research that we've done and discussions that we've had with a pretty large base of endocrinologists around the opportunity here.

But maybe, Milan, you have some additional, no, okay. Bruno, let me know if that further clarifies?

Yes, yes. Thank you.

Management, there are no more questions registered at this time.

So then let me thank everyone for joining today for your questions. You can hear our excitement not only about the solid performance in the first 9 months, but also really in the -- what lays ahead of us, really good opportunities, of course, with some challenges as always, and we will manage them as always. But the opportunity is wonderful, and we continue to be a very nice profitable growth company with a very clear mission on helping patients everywhere in the world. And we're all proud to lead this company.

So thank you for joining today, and I hope to see you all in person soon.

Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.