Good afternoon, this is the calls conference operator. Welcome. Thank you for joining the Recordati first quarter 2026 Results Conference Call. As a reminder, participants are in listen-only mode after the presentation, there will be an opportunity to ask questions should anyone need assistance during the conference call, they may signal an operator by pressing star and zero on their telephone. At this time, I would like to turn the conference over to Miss 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 and Primary Care. As always, the presentation is available in the investor section of our website. It is now my pleasure to pass the call over to Rob. Please go ahead.
Thank you, Eugenia, good afternoon, good morning, 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 a constant exchange rate basis. Growth was primarily driven by the exceptional performance of our rare disease business and the resilient in-market growth of SPC. FX had an adverse impact of 4.3%, largely due to the US dollar.
Turning to profitability, EBITDA was 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. With that, I now hand over to Mike to walk you through our Q1 2026 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 ex-constant exchange rates, growth was 22.4%, highlighting strong underlying momentum in endocrinology and hemoncology, 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. 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.
Hematology 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 positively, growing 13.9% across geographies. Metabolics, 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. As you mentioned, I am very pleased with the performance of the rare disease business overall in quarter one, and it is particularly underpinned by the exceptional performance of ISTURISA in the first quarter, and the momentum continues to grow and accelerate month-on-month. 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 complete, the team has been trained, and they're out in the field, and we expect them to start making an impact immediately. 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 and congress presence and continuing to generate robust real-world evidence in the communication plan. 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. 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. Finally, I'm very pleased to say that our phase IV trial in adults with mild hypercortisolism and uncontrolled hypertension is on track to start in a few months, later this year.
That's really highlighted by the metrics that you can see there on the right-hand side of the slide. We've had more than an 80% increase in our non-overt population versus Q2 of last year. That's really sort of the target because that's when we, as you can recall, achieved the extended label for our ISTURISA in Cushing's syndrome, allowing us to now treat more non-overt patients. 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. We're seeing that trend continue into April and of course into May.
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. Of course, that all translates to a very significant volume growth and demand in the U.S. of more than 48% versus the same quarter last year. Overall, you know, very pleased with the performance and look forward to another strong quarter in quarter two. 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. On this slide, I will walk you through our PBH phase II program. As we have said before, post-bariatric hypoglycemia represents a very significant unmet medical need, and there are today no approved therapies. On the strength of that, we very recently completed our core phase II trial comparing pasireotide to placebo in patients with post-bariatric hypoglycemia. 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. 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 registration of a 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. 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%-30% that are actually inadequately treated and do not obtain, you could 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. 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, would be a durable platelet response after 24 weeks. We expect to initiate this pivotal phase III trial in the beginning of 2027. 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 end -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 a constant exchange rate, the business was broadly stable, with 0.2% growth on a like-for-like basis. 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. 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 VASCEPA at EUR 5.2 million helped offset the loss of Cardicor. Gastrointestinal growth was led by Procto-Glyvenol, while cough and cold were 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 nine. This provides a breakdown of the geographic performance for the quarter, highlighting exceptional growth in the U.S., partially offset by one-off headwinds in selected regions. We achieved significant growth in the U.S., with revenues of 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%. 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 a weaker cough and cold season and a one-off Tergynan effect following its 2025 relaunch, resulting in a challenging prior -year comparison and softer local currency performance. Turkey grew 21% in local currency, confirming strong underlying market dynamics. Portugal and other Western 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 EUR 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 remaining strong and in line with our full-year expectations.
We ended Q1 with leverage just below 2 x net debt to EBITDA. Finally, we're confirming our full year 2026 financial targets. We expect net revenue in the range of EUR 2.73 billion-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. The fundamentals of the business remain strong. 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 US dollar.
For EBITDA, we expect a range of EUR 995 million-EUR 1.03 billion, including investments behind ISTURISA's opportunity in the U.S. and the FX headwinds of roughly 4%, leading to sustained sector-leading margins of approximately 36.5%. For adjusted net income, we expect a range of EUR 655 million to EUR 685 million, with a margin of approximately 24%. Our 2027 targets remain unchanged, with strong organic growth expected to be complemented by ongoing BD and M&A despite facing currency headwinds. With that, I'll turn the call back over to Rob to open up the line for Q&A.
Thanks, Mike. Before we do so, and before we enter into the Q&A, I want to make clear that on the theme of a 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, we'll keep you updated if anything relevant happens and when anything relevant happens. With that, I'm happy to answer your questions.
Thank you. This is the call conference operator. We now begin the question-and-answer session. Anyone who wishes to ask a question may press star and one on their touch-tone telephone to remove yourself from the question. Please press star and two. Please pick up the receiver and asking questions. Anyone who has a question may press star and one at this time. The first question is from Sophia Graeff Buhl Nielsen, JP Morgan.
Good afternoon. Thanks for taking my questions. 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? Also, we've seen a strong uptake in terms of the non-overt population year-on-year. What's your current assumption about the rate of diagnosis for the non-overt patients? What increase in diagnosis rate is assumed in terms of your peak sales guidance? Thank you.
Hi, Sophia, this is Scott. Thanks for the questions. I'll take the first one around the uptake. I believe it was the uptake for the year so far.
In the uptake, I mean, we're very pleased with what, you know, we've seen. We expect that there'll 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. 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, you know, we're not tracking on a quarterly basis what our increase in the diagnosis rate is.
Obviously, having more people in the field, particularly the MSLs, and being present at congresses and starting to talk more about these non-overt populations, 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. 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. Now that we have the full complement of MSLs in the field and the new people that are coming on the commercial side, we do anticipate that those rates will continue to increase and for us to pull through additional non-overt patients in the coming months.
Thank you.
The next question is from Kirsty Ross-Stewart, BNP Paribas.
Hi, good afternoon. Thanks for taking my questions. Maybe another one for you, Scott, on ISTURISA. Just a bit more detail on the dynamics of the new patients you're seeing. Are you seeing switches from Korlym, what proportion of new patients are switches versus naive patient starts? Are you able to tell us kind of what proportion of your currently treated patients are coming from the non-overt population?
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 -year opportunity. Just wondering if I could get a bit more detail on the assumptions that underlie that assumption, because it could be seen as a little bit conservative given the relatively large addressable market. Just interested in what you're assuming in terms of bariatric surgery rates, penetration, key markets, etc., that underlies that current peak sales opportunity. Thank you.
Okay, sure. No problem. Around the number of patients that we have on non-overt versus overt, I mean, again, that is still hovering around the 20% of the population of patients. If you can recall, you know, the non-overt is our core business, and this is something that 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 are a work in progress. We're pleased with the uptake of non-overt that we are getting.
As I mentioned during the presentation, the build-out of the sales force is allowing us to go into the community to, of course, you know, try and find more of those non-overt patients to pull through. We're very pleased with the number of enrollments. I just maybe I'll just 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 ISTURISA prescribed. As I also mentioned, I mean, the pull-through from enrollments to an active patient is that insurance process, which, you know, is a bit sticky in the first quarter of the year, and it's not just us.
There's been a lot of changeover of insurance since Obamacare ended. There's a bit of churn there. We're seeing that start to smooth out now. That is, you know, something that we and many others in this space are also finding we're having far more enrollments than active patients. That's a good sign. That means demand is there. That means people are waiting for their product. We're very happy to say that for the non-overt population, the enrollments are above our expectations in that space. That's really great news. With Yeah, then the switches, I mean, you know, we don't really comment on where we're getting the patients from. I mean, I can't tell you specifically the number of patients coming from Korlym.
You know, we're getting pull-through from, you know, all of the similar channels that we have been in the past, and that continues to drive our patient uptake. With regards to Signifor, you're absolutely right. I mean, that'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 and how the surgery rates are changing, given the GLP-1s in the area, in the region, and given what the future may hold once the trial is complete and we do have that product on the market. I can tell you that we're very excited about the way that market is evolving.
Further updates will come in future meetings when we can actually give you a revision of our peak year sales.
Thanks very much. Appreciate it.
The next question is from Niccolò Guido Storer, Kepler Cheuvreux.
Good afternoon. Thanks for answering my three questions. The first one is about cost to support ISTURISA in the U.S. Was Q1 already at cruising 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 indications for existing drugs. EUR 150 million peak sales for Signifor's new indication. Have you ever indicated a similar, let's say, indication for sutimlimab in Enjaymo?
If yes, I missed it. if you can recall it. 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? Thank you.
Niccolò, acoustically, we couldn't quite get the third question.
Yeah.
I heard the word "Russia," but that was it.
It's about the one-offs in SPC. Is it just Russia?
Yeah, it was about the headwinds you mentioned in SPC, and I was wondering if those were just related to Russia or also to something else. If this is the case, can you specify what these headwinds are related to?
Okay. I'll let Alberto comment on that. 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 and France, and we've seen it not just with us, but there's been a very low season for that in general. I'll let Alberto comment on that a little bit more. Before I do, maybe just on the opportunity in PBH. Yeah, 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.
Much like Kirsty also indicated, there are 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 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.
From our first phase I trial data, we know that there is a very good possibility to control for about 40% of patients with 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.
Yeah. In terms of the ramp-up of costs to support ISTURISA, Q1's not at full speed yet. We'll get closer to that in Q2. You know, a lot of the reps were being brought on in the back half of Q1, as well as some MSLs and a few others. Then we'll see some other costs ramp up. I don't think we'll be at full speed probably until Q3, Q4. We are on pace to invest a little bit more this year and then have a full year impact in 2027. 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 we've also seen it in other markets , including Italy. 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.
Still, our urology portfolio continues to grow, and we are confident in being able to bring it back into positive growth terms in the coming quarters.
Perfect. Thanks, guys.
Thank you.
The next question is from Martino de Ambroggi, Equita.
Thank you. Good afternoon, everybody. Two more questions on ISTURISA. In Q1, you added 110 prescribers. Could you remind us what the total number is nowadays? In terms of active patients, in the last presentation, you indicated [1,400] in the U.S. Frankly, I'm sorry if I missed it. Could you remind me what this number is at the end of the quarter? Changing the subject, on tariffs in the U.S., can we say we are safe? Never say never, obviously, but let's say under the current regulation, there are no more risks so far. In Germany, do you have any visibility on the ongoing discussion if it's really affecting your portfolio in Germany or not?
Very last, on the Signifor PBH, okay, peak sales are clear; your comment. Could you elaborate on the best estimate for the timing? Thank you.
Thank you, Martino. Lots of questions. Maybe in 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.
Yeah. 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 could 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.
Maybe Martino de Ambroggi to make it. We do expect that one phase III trial will be enough. Before we have agreed on the exact timing and details of that trial, I think we should not guide you on the exact timing. It will require that one phase III trial in the 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 Diseases seems to be in a good space in this discussion. What we have done proactively, and Mike alluded to, is 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 2026, we're absolutely secure and have been able to bring products to the U.S., that even if there were a tariff, for which we have no sign at the moment, and there seems not to be any immediate possibility that this comes. Even if it would, it would not impact our 2026 figures at all. Maybe on ISTURISA, Scott.
Sure. Thanks, Rob. A couple of questions on ISTURISA. Let me start with the second one first, which is the total number of ISTURISA patients that we have on treatment. We've closed with more than 20% additional patients since the first quarter. 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, like I mentioned, the net patients that are on therapy are more of a function of the patients that are pulled through from the enrollment.
You know, we have seen, as I mentioned in the first quarter, a bit of a delay in getting those patients from enrollment to net active patients. I think a more fair measure of the performance is the enrollments, which I can tell you are going very, very well, particularly, as I said, in the non-overt population. We're very pleased with that. That's a factor, as is your first question, which is the number of the prescribers we have. I don't have the total number of prescribers to share with you, but I can tell you that the new prescribers that we're putting online are many ; they are coming from the non-overt population. Again, it is a good sign of the momentum starting to build in that space.
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-à-vis Cushing's syndrome. I think all in all, the metrics are all trending in the right direction, and we've seen a really nice uptake in the first quarter.
Okay. Thank you. Very last follow-up. Over the EUR 40 million- EUR 50 million additional costs this year to push ISTURISA sales, how much was in Q1, if you commented on it?
We just commented on the last answer that we were not at full speed. We are not going to give an exact number, but we will be at full speed in the second half, so a little bit less than a quarter of that.
Okay. Thank you.
The next question is from Natalia Webster, RBC.
Hi there. Thanks for taking my questions. Firstly, a follow-up on 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. I just wanted to ask how this frames your thinking on the regulatory path from here, particularly for the phase III primary endpoint. Finally, just on M&A. Appreciate you're not going to talk on the discussions with CVC, but are you able to comment on whether this has changed your strategy around evaluating BD opportunities? Thank you.
Thanks, Natalia. Let me take the last question. We're fully committed to continuing, as we have to be disciplined on M&A, but we continue to pursue opportunities both in SPC and in rare disease, and we have a multitude of discussions ongoing. I think someone has his line open. It makes a whole lot of noise. Our M&A strategy hasn't changed, and, if anything, I think I don't want to speculate on what the future will hold, but I would be surprised if anything would change other than just stepping up seriously. This remains to be extremely important for Recordati, and we keep focused on that and are actively engaging.
Maybe I'll jump in with the first question around the new prescribers. 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. Many of those prescribers only have one patient. I think it's important also that we recognize the repeat prescribers and how we have many prescribers who are prescribing to new patients and to multiple patients ' ISTURISA. I think it's really important to look at both of those. 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.
Again, you know, we expect that number to increase because this is pivotal for us to get to those people, to get patients on in the non-overt space. We anticipate those numbers to improve and to continue to grow over time. Maybe I'll hand it over to Milan for the Signifor question.
Yes. Thanks for your question. 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 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 higher baseline event rates, and that allows us to make informed decisions around sizing, etc., of a potential phase III trial. Thank you.
Great. Thank you.
Gentlemen, there are no more questions registered at this time. I turn the conference back to you for any closing remarks.
Thank you. Thank you, operator. 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 for both businesses is doing even a little better than at least the market seemed to have expected, and we're very happy about it. We're confident in being able to keep the momentum. I'm also particularly happy with the fact that we've been able to enrich our pipeline, and we're making really good progress in R&D with some meaningful opportunities for patients and economically, financially, and commercially interesting opportunities for Recordati that we will keep you updated on. Thank you for spending time with us today, and I 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.