Gedeon Richter PLC (RICHTER) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to Gedeon Richter's First Half 2025 Conference Call. My name is Robert Rethy, I'm heading Investor Relations and ESG at the company. And today, it's my pleasure to welcome 2 of our senior leaders with me in this call, Gabor Orban, our Chief Executive Officer; and Laszlo Kovacs, our Chief Financial Officer. Before we start the presentation, let me just quickly guide you through the technical -- usual technical details. We will be following a formal presentation as usual, using the slides, which we published this morning and which is accessible on our website, gedeonrichter.com. This will be followed by a Q&A session. [Operator Instructions] Let me remind you that this call is being recorded. And also, let me bring your attention to the cautionary notice at the last slide about the potential forward-looking statements, which may be included in the presentation or during the call. And with that, I would hand it over to Gabor, who will present the details of the last quarter.

Good morning, everyone. Thank you for being loyal participants of our earnings calls even in August. I appreciate very much your attention and presence here. Let me begin by saying we are very proud of what we have achieved so far this year. Despite the strong base, especially in Q2, we have managed to catch up with our guidance in the second quarter of 2025. And so we are now well on track to deliver what we announced and guided for in February, which is a 10% revenue growth ex foreign exchange effects and the same rate of growth in clean EBIT with the new stricter definition, again, at 10%. In the first half of 2025, we are on track to deliver on both of those ambitions with pharma sales growing at 10.7%. There was a tailwind of 3 percentage points here from exchange rates. We'll discuss those in more detail. And clean EBIT grew by 15%. FX adjusted, this is equal to the guidance rate of 10%. EBIT itself grew by 11%. And the only reason that free cash flow didn't follow suit was the realized losses in this period due to a decline in the value of the dollar, most of all. And other than that, we've seen very healthy cash flows also -- operating cash flows also in the first half. I mentioned the strong base that we had to overcome. This was particularly true in women's health, where Q2 last year saw some pre-shipments. Again, I'm proud of the fact that we have delivered despite those challenges. I'd like to mention upfront 2 points that we are particularly satisfied with, both pertain to the innovative pillar of our operations. We now have 2 Phase II trials ongoing with our 932 neuropsychiatry compound. It's being developed jointly with AbbVie in 2 indications now, and this is why we earned a milestone payment in this quarter connected with the launch of the second Phase II trial. We are well on track to have a new original compound by the time Vraylar goes off patent. 932 is a very promising project. The second thing I'd like to point out is our collaboration with Granata Bio, a very impressive and remarkable U.S.-based fertility company. This is our first major step in establishing our presence in the U.S. fertility market, which is a growing market, which has a lot of potential and a lot of unmet need that we aim to serve for the U.S. population. At the same time, we have done a decent job at maximizing existing brands in women's health, most of all menopause and endometriosis. As you know, we are the only company that provides a targeted symptomatic treatment for endometriosis, a disease that afflicts at least 1 in 10 women. And I'm proud to be the company that dedicates resources to researching and the discovery of a disease-modifying therapy, which we aim to bring to the market in the 2030s. So with that, let me jump to a slightly different topic, which has to do with our social and environmental commitments. We work for the benefit of humankind every day. So for us, these things are not completely foreign or alien. We look after the environment as much as -- well, not the same extent, but with equal dedication as we look after our operations. And for that reason, we aim to make our operations, production, so productive manufacturing infrastructure and also the admin operations sustainable. And we've made significant progress in doing that in 2 important ways. One has to do with the share of renewable energy in our total energy footprint. Not only are we committed to decreasing the absolute level of energy consumption year after year. But we're also committed to increasing the share of renewables within that energy mix every year. And this is the first year when I -- well, not the first year, but this is definitely one important point in time, the first half of 2025, where we have tangible results from the efforts of many years. We have installed solar panels in our Romanian and Hungarian sites. And as a consequence of this, our own renewable electricity generation saw an increase of 60% in the first half of 2025. Secondly, we have entered into power purchase agreements or one particular power purchase agreement with a 3-year time frame, just signed recently, which allows for a 24 gigawatt hour per year wind and solar electricity starting from 2026 all the way into 2028, which is our hybrid approach to increasing the share of renewables, generating our own renewable energy source; secondly, purchasing green energy. These 2 help to significantly reduce the environmental impact and improve energy supply reliability. So we are proud of what we've done on this front. The second thing I wanted to mention is also pertinent to the environmental commitment -- to our commitment to environment protection and sustainability is the paperless transformation, which we began after I was appointed to lead this company in 2018. We started out having or using 110 tonnes of paper every year. We managed to bring that down to 70 in the COVID year of 2020. And the challenge we were facing at the time was how to maintain those levels and possibly bring them further down. And so that's -- we had to redouble our efforts. And as of today, the number I can report to you from last year is 45 tonnes. This not only reflects the impact on the environment, but also the improved business processes within the company, the degree of automation having increased significantly. Remember, in this period, our sales revenues went up twofold and our positive impact on society accordingly. So I'm proud of the way that we have achieved all of this by relying on fewer and fewer external environmental resources. So as you know, in pharma, it's always the benefits and the effect against the side effects. Here also, the side effects have been cut in half and the effects -- the positive benefits have been doubled, and that's a great balance in my view, between benefits and side effects. On to the more boring stuff with financial highlights and the revenue structure in the first half. As you see in all of our regions, growth was maintained, a healthy rate of growth was maintained. There are some pockets of stagnation here and there, smaller markets where we did not manage to grow the business; Latin America being an example, where the base was particularly strong in the previous year, given the uneven seasonality of shipments I mentioned earlier on. Also, Ukraine seems to be a tough nut to crack for us. The absolute level of sales have gone down in this in these 12 months, so since first half 2024. As I mentioned, we had a tailwind of 3 percentage points coming from exchange rate developments, the half being weak translated into positive exchange rate effects on all 3 of the cross-currency pairs that we are exposed to, most importantly, the U.S. dollar, ruble and the euro. Those are the 3 most important exposures we have on the revenue side. The extent of the tailwind, the, let's say, push from the tailwind went down to about 1/2 of what it was in Q1, still was positive. So it added up to a nice positive impact worth more than HUF 10 billion. But the weakening of this tailwind shows the decline in -- or the deterioration of exchange rates from our point of view, which is also reflected in the financial account, the main reason being -- the main reason behind the free cash flows not keeping pace with EBIT. When it comes to business units, all of them performed according to plan with women's health being the star in Q2, outperforming what was a strong Q2 in the base and even net of FX growing at double digits. So that's a remarkable performance. Menopause, endometriosis and Drovelis -- well, so menopause, endometriosis and contraception all contributed to this massive performance with Drovelis, Ryeqo, and Lenzetto adding to the momentum in women's health. General Medicines posted slower rates of growth in this second quarter after being the star in the first quarter. That's the nice thing about our business model, having a more diversified business. We have at least one cylinder firing. GenMed wasn't the one this time. We have a 5.2% growth net of FX, which has to do with supply problems in -- related to API, starting materials, fine chemicals. The portfolio here is broad and there's always supply chain issues to manage. We had our fair share this quarter, unfortunately, or these past quarters rather, which then took their toll on Q2 2025. We also had to write-off inventory to an extent that was not foreseen and is not our goal and not our steady state. That said, in the full year, we continue to aim for a significant reduction in the value of inventory write-offs in all business units. Biotechnology moved forward forcefully, both on the teriparatide and the CDMO side, 9% ex FX growth is what we achieved year-on-year. And finally, neuropsychiatry, again, delivered above expectations, not the ex-Vraylar component, but Vraylar. Despite the headwind from Medicare regulation changes that was expected in the amount of $200 million by AbbVie. The volumes and scripts grew double digits ahead of expectations, which led AbbVie to raise their guidance on -- well, generally, their guidance by $200 million, which is divided between 3 brands, one of which is Vraylar, which means that implicitly, the Vraylar guidance is now higher by 1/3 of $200 million in AbbVie's outlook. This translates into royalty revenues for us, but not to a degree that we'd adjust our guidance on the back of this. Still, there's upside to our [ spring ] outlook in 2025. We knew that the Medicare changes would not affect the first months. Okay. Thank you, Robbie. Sorry about that. We knew that the Medicare reforms would not be front-loaded. They would affect mostly the back of the year. The net effect of everything that's happened to Vraylar this year is a small positive upside so far. Moving on to costs. We have implemented a number of very strict cost controls this year in order to track the strategy ambitions when it comes to the cost side. And partly as a consequence of this, costs have kept -- the rate of growth of costs have kept below revenue growth. Sales and marketing expenses grew by 10%. Ex FX, this is only 7.5%, so it's still true that it's below the average rate of growth, but it also reflects some targeted investments in certain field force headcounts in order to benefit from the growth of generic markets to the East, mostly former Soviet Union states, CIS states, and some others. The R&D cost structure changed somewhat with biotechnology easing off a little bit as foreseen. We spoke about this many times that developing 2 compounds at the same time is a cost-intensive pursuit. And so once the regulatory phase arrives, which is today, those costs will be lower, and that's the case today. Denosumab has already been approved by the European authorities. The U.S. process is ongoing and the tocilizumab dossier has been submitted. So we are now in the finish -- close to the finish line with those compounds. This is reflected in lower R&D costs. However, some of that is picked up by the women's health business unit because we're investing in the original pipeline now that the Belgian Liège-based R&D capability is up and running. This is partly the reason why G&A did not slow -- G&A cost growth did not slow down a bit more. It went up by 10%, but about 1/3 of this was related to the acquired entity. Finally, I'd like to share with you the net effect of everything that I've spoken about. It's a 10% FX-adjusted growth in clean EBIT with the stricter definition, which now includes impairment and write-offs. And the composition of clean EBIT is, of course, once again tilted toward neuropsychiatry, Vraylar taking the lead. But taking into account the shifts within the R&D budget, my assessment is that the other business units have pulled their weight so far this year according to plan and according to expectations. Now I'm asking our CFO, Laszlo Kovacs, to discuss below-the-line items and cash flow.

Thank you, Gabor. Here, as usual, you can see a breakdown how we arrived from clean EBIT to net profit. The big game changer in this first half of the year was the FX, which turned into significantly less gains than it was a year before. There's a difference also from clean EBIT to EBIT that in this period, besides the normal smaller items, we had to record some legal-related provisions. This is a consequence of the prior year's acquisition. We built some decent escrow account. But as usual, in these cases, we evaluate the potential chances of further litigation costs and we build the required level of provisions there. On the other part of the chart, you can see that the FX gains altogether only adds up to HUF 3.2 billion compared to HUF 24 billion of gains in 2024. Now that's a massive difference. What is there behind? So we -- here, we have HUF 6.6 billion of unrealized gains; while on the realized part, we suffered HUF 15 billion. And why is that? In the second quarter, there was a significant depreciation of the dollar, and we had significant open receivables coming from Vraylar and other accounts. Plus when we make any changes, so we transfer some USD accounts from one bank account to the other, as per the required accounting treatment, we need to account for realized losses. So that is the consequence. On the other part, we had some decent HUF 2.3 billion of gains from hedging and forward transactions where we follow our strict risk management policies for Vraylar, expected cash flow hedges. The third largest item is taxes. Since we are under the regime of GLoBE, our effective tax rates increased significantly. But in this year, in particular, we have some one-off effects. You can see that the effective tax rate percentage is around 17%, which is higher than the expected 15-ish amount. And the reason behind this deferred taxation, we had to build some deferred taxes for certain assets that we had to build on the group level as part of the acquisition from 2024. So we expect them to decrease by the end of this year. This is something that were still with us in Q1 and will remain in Q2, but we expect that the effective tax rate will improve getting closer to the end of the year. Now if we turn the page to the free cash flows. As Mr. Orban just highlighted, we still had decent free cash flows around HUF 121 billion. Now the lack of unrealized FX gain that were there in 2024, the basis of the net operating cash flow is obviously lower. The other big portion is, we just highlighted that in general medicines, our priority was to make sure that we're able to serve our patients. And although the problems we faced were a bit different, mainly related to starting materials, APIs and some other chemicals, we had to invest around HUF 38 billion into net working capital. We managed to keep our CapEx costs at a lower level 35% lower than in the previous year. Some of this is really the result of the procedures we put into place, very strict stage-gate processes. On the other hand, it's purely timing, so we think that altogether, we are on track of following our annual internal CapEx caps. And maybe a third thing that I would like to highlight is that compared to the previous years, other M&A is lower. Gabor mentioned Granata Bio and the Adalvo cooperation, what we had in the previous years. But as we established our hub in R&D, it's kind of natural that we spend lower amounts here for M&A, and we have higher level of R&D expenses. And as I mentioned acquisitions several times, I just wanted to share with you that the stand-alone financial statements of the estetrol business is showing a positive result as of the first quarter, which is totally in line with our expectations. We are collecting royalty income. We are collecting some milestones. And at the moment, they are higher than the actual R&D cost that came up. But all in all, as we are having higher net working capital, the reported cash conversion cycle is higher than it was in Q1, although a bit below the Q3 figures. We expect to work a bit more on that until the year-end to push this trend back to the normal course of operation, what we expect.

Thank you, Laci. And some final thoughts from me on R&D and the progress we're making. In women's health, the Granata Bio contract has been mentioned several times. We see this as an important way to add value to the U.S. fertility patients. The partnership is strong. The company that we've invested in and that we're working with is doing a terrific job. So we're very pleased with the way that progress is being made on that front. In women's health, our original innovative focus is squarely on endometriosis. And this is one of the underserved markets, as I have mentioned several times, but it's also one of the under-researched indications globally, possibly the most under-researched if we standardize with the number of disability adjusted life years that we can expect to have by treating endometriosis. So the research funds allocated to this indication compared to the social benefit that it can generate, this ratio is among the highest of all diseases out there, which is why we feel that we have a special commitment, and we have a special -- there's a special need for us to fill this hole, this gap in global drug research. In neuropsychiatry, we've already touched upon the 2 Phase II studies that are ongoing. We have a compound in Phase I, getting ready for Phase II. We'll take that decision a bit later, but there's a stand-alone project underway and our preclinical research and now development projects are also progressing. In Bio, we've already covered everything that's to know. We are in the first wave of Toci and Deno launches in this year -- late this year and next. So we are happy and looking forward to that. And finally, in general medicines, there's a lot to do. There's a lot of patents expiring in the coming months and years. The multiple sclerosis launches will be significant to the GenMed business. The cardio-metabolic compounds, including anticoagulants continue to be a driver of portfolio freshness something we're paying special attention to, to elevate the level of portfolio renewal in GenMed. We've doubled this rate already from previous years, and we're keeping at it. And finally, the semaglutide injection development, which is a global project that we have signed in recent -- in the reporting period. Again, it will be a contributor to margins and growth in the future for GenMed. So there's continuous momentum in the pipeline in each of our 4 business units that -- which enable us to deliver our strategic goals in the next 10 years. This was it from us this morning. And now we're -- the floor is back to Robbie.

Thank you very much, Gabor. And now we are ready to take your questions. [Operator Instructions] Happy to do our best to answer your questions. So the first question is coming from Dawid Górzynski.

I want to ask about Women Healthcare segment. At the first, if you could provide a bit more color on this increase in R&D costs in the second quarter, like is that -- like was that fully related to this new site in Belgium? Or -- and am I right that this is like from the acquisition like concluded last year or maybe like some other projects? And if this level in second quarter is a good run rate for the future? And the second, on Women Healthcare as well, like in the Excel file that you disclosed, you no longer provide -- like you no longer list oral contraceptives within key products in Women Healthcare. And I wonder why you decided for such change right now.

I'll start with the second one. Actually, we didn't stop providing data on contraception. We changed the structure of disclosure in line with our -- how we presented our strategy and how we are managing the business. So now you can find on the data sheet on the Excel data file in Women Healthcare, a breakdown of sales by therapeutic areas and contraception is clearly one of the -- or the single largest therapeutic area we are covering as of today. Of course, now contraception includes not only oral contraceptives, but that includes Evra as well. It includes the innovative oral contraception, so Drovelis. So it's slightly different. But I think with a little bit of additional work, you can more or less arrive at the previous type of data we provided. But this is -- going forward, this is primarily how we are looking at this business.

Thanks for your question, Dawid. I'll take the one on women's health R&D. First, yes, all of the costs are incurred outside headquarter, technically speaking, meaning there is, of course, an allocated amount coming from the maintenance work and all the rest of it from -- within headquarter, but there's absolutely no different from what it was in the past or even lower. What we have, on the other hand, is increased spending by the Belgian entity. And this has to do, like you said, with the acquisition. We acquired not only cash flows, but we also acquired a team, and we also acquired duties and responsibilities connected with E4. The reason we acquired those is because if we hadn't acquired them, they'd go down the drain and E4 would no longer be on the market. And our goal was for E4 to be available to patients, which is why we acquired the E4 project along with its liabilities, including post-marketing studies and including the development costs associated with additional indications. So that work is ongoing, plus the team is now focused on partly the projects connected with the former BCI platform, but also others. that are promising and help us move forward into indications such as endometriosis, PCOS, et cetera. Those are the 3 components of those costs in women's health R&D and maybe even 4 components. And whether or not this is the steady state going forward, our CFO will know, hopefully.

At the moment, I wouldn't take it as a normal run rate. We made sure that now this whole R&D hub is operational. We have the basis to move forward. And if we start increasing the number of projects, then the rate could be higher. But everything that happens is completely in line with our internal budget. So there is no effect on the potential guidance. On that front, just because of that, there can be timing differences between quarters. That's why I wouldn't take it as a normal unchanged run rate for the future.

Maybe add a few words on the extent to which the Granata collaboration affects the R&D spending.

Yes, that also has an effect because we would like to get into the U.S. market in the fertility business. And this will have in the second part of the year and going forward, some further costs that we will account under Women's Healthcare, which we are doing in cooperation with our partners. So that is what you might expect there.

Next question comes from Bram Buring.

Okay. Just a few small questions, please. Yes, you mentioned that we saw that impairments in -- for inventory in General Med was quite high. Could you give an indication of where you think it might be at the end of the year? Or are we going to see any other write-offs in the second half? That would be the first question, please.

Okay. Thank you, Bram. Yes, indeed, the expectation was for our efforts to reduce this to be reflected already in the first half of the year. That is not the case, but it will be reflected in the second half. So the full year write-off or impairment costs will be lower than the previous year by a significant margin, not 50% but more than 10%, surely. I should not give you a tighter range at this point, I'm afraid. But the second half of the year is expected to deliver the reduction that was foreseen for the full year.

Okay. And then when you were speaking about endometriosis, you talked about the timing of going into Phase II with one of those drugs. Can I just check, which one exactly we're talking about?

I'm sorry if I misspoke. I didn't mean to say that Phase II is around the corner for endometriosis. We are in discovery and research phase for now, except for the fact that there are projects out there pursued by smaller biotechs, some by bigger pharma companies that are available for in-licensing, which we are currently evaluating. So we can buy time, even a few years, so even several years by in-licensing an existing development project, and that could accelerate the progress for us in endometriosis. Other than that, we are not at the clinical phase yet.

Okay. So this isn't a molecule that we've seen as it works.

No, no.

All right. So this is something new.

The one what Gabor mentioned, which may potentially move into Phase II and currently in Phase I, that's a CNS. That's a stand-alone CNS project un-partnered for now. And next question from Gabor Bukta.

You mentioned at the beginning of the presentation that you are proud of what you achieved this year. But to be honest, I'm a bit disappointed when I attempt to look behind the current developments. So you implemented a strict cost control, but I see, especially in the women's health care and general medicine segments that the gross margin declined on a year-over-year basis. And I'm just wondering if it was coming from a mix of adverse impacts or what has happened? And the second question is with regard to the impairments. So have you seen any kind of sort of similar patterns in July or in August or -- or is it possible that you have to impair some more assets going forward? What's the reason behind this move?

Thank you for your questions. On the impairment first, this is technically may be an impairment, but it's really inventory write-offs. So finished products, which for one reason or another do not comply with the quality standards and have to be destroyed. That's what these are. So it's not asset impairment as such, like an intangible or whatever. And we are quite confident that in the first half, we have absorbed the shock and let's say, swallowed the -- to be very stylish. And I expect a lower inventory impairment cost in the second half of the year. As far as the gross margin is concerned, don't forget that we are fighting an uphill battle in both of those business units. And this has to do in women's health, in particular, with the new brands carrying a lower gross margin than many of the well-established cash cows from the past. So this growth rate that I think is remarkable and is a source of pride for us is achievable if we are a bit more lenient on the gross margin side, given that it's relatively high as it is at 70%. Finally, I mentioned the strong base to you in the in my introductory comments. And the strong base, unfortunately, was strong -- well, unfortunately, it's a matter of perspective, but it was strong in the gross margin sense also. In fact, it was even stronger than the average, meaning those pre-shipments in Q2 2024 happened to be from among the highest margin products. So if the margin was strong from a revenues point of view, the margin was double. The base was strong from a revenues point of view, it was doubly strong from a margin point of view. That was -- finally, I could spit it out, sorry, if I confused anyone. But that's the point. Q2 last year, pre-shipments were highly profitable products.

So -- but if this is inventory write-off, this is a more serious issue, I guess. And so I'm just wondering when you recognized this, could you fix it? And is there an internal or external pressure or issue?

Yes. Inventory write-off had to do with noncompliant starting material coming from one of our European -- I'd like to blame it on someone, but I cannot, so European suppliers. And the problem has been fixed and the market stock out is also addressed. So we have identified improvement points and acted on this to minimize impact. That said, the manufactured batches are noncompliant and had to be written off. So yes, this is in the past.

Gabor, is it possible that this will be a negative impact on Q3 numbers, on sales?

It might have a negative impact, but it should not affect the guidance. So it could be offset by other items, which provide a balancing effect. It's too early to say the extent to which the stock-out situation has been -- or the severity of the stock-out situation remains to be seen. But it's under control, and it should not disrupt the numbers for the second half.

The next question comes from Chris Richardson.

Just a couple on the bio division. On CDMO, you commented on uncertain dynamics on the part of your customers. I was just wondering if you had any more detail on that? And is this early-stage customers? Is it perhaps a funding issue? And then just a second one on biosimilars. There's a comment about lower-than-expected volumes. I was just wondering if you can comment on what dynamics you're seeing in the biosimilar space, whether it's pricing or specific regions? And just if you had any sort of high-level commentary on that.

Thank you, Chris. On CDMO customers, I think the general landscape is one in which some of our customers, not just ours, but the European industry as a whole is facing uncertainty coming out of the U.S. The extent to which U.S. regulations will allow or enable or dis-prefer European sites developing and manufacturing biological products is highly uncertain. So we do see that, yes, at the level of customers, not at the level of capacity utilization or cash flows yet. But clearly, this is an issue for everybody, not knowing if it's safe to bring manufacturing to Europe. So that's what the comment was referring to. And whether it's funding also, I believe it could be, maybe not yet acutely, but in the long term, NIH grants, universities being defunded, so to speak. And whatever price limitations may -- whatever impact price limitations may have on R&D spending in the pharmaceutical industry as a whole, all of these can lead to lesser interest in biotechnology, CDMO services. Now given the imbalance between interest and capacity that we have had over the years, I don't see this as a major threat. Because there's -- so far, there's been an order flow, which the industry could not accommodate. So even if it's a bit weaker, we can still run at full speed. That said, the general landscape is what it is. When it comes to lower volumes, I'm at a loss here, not literally, but I don't know what it was about. So Robbie, maybe you can help me out.

Yes. One thing you may be referring to is that even though we had relatively decent growth in teriparatide, I mean we have only one biosimilar on market for now. And even though we had decent growth, we still had some constraints in terms of our partner supplies. And the reason for that was that we had to prioritize capacity because not only we are ramping up and full after last year issues, but also preparing for the denosumab launch, we had to make some quality upgrades in the manufacturing plant, the [indiscernible] related. So therefore, capacity was actually not fully available to satisfy all supply, which was quite -- all demand, which was quite strong during the period. I mean these are now being resolved by introducing new shifts, new lines. So hopefully, smoother situation for the coming periods, if this was behind your question.

Yes, it's based just on the comment in the presentation that the gross margin was perhaps slightly inhibited because of lower-than-expected volumes and higher cost of sales.

Yes. This is exactly.

Then maybe just -- okay. And then just sneak in a last one just on denosumab. I'm wondering, are you targeting the Prolia or the XGEVA indications out of interest? Or is it -- I know you're approved in all of them. I was wondering if there was a preference or one indication you're saying is more sticky potentially for the originator than others.

In Europe, we are -- I mean, we are approved for both in Europe. I mean, legal for both indications, and we want to be in the market for both. Europe, we are approved in U.S., it's under review.

It will be different in each country within Europe, how uptake will evolve, they are distributed in different channels, one more in the hospital channel, the other one maybe more prescription-based outpatient. So what I like about this opportunity is that it gives us leeway to leverage our capabilities -- commercial capabilities in each European country in the way that we maximize the potential of the brand. But we work with both osteoporosis being the one closer to home in the sense that, that is our bread and butter in biotechnology. Oncology, less so. But still in some markets, we expect that product to be more successful than the other one.

Next question is coming from Vladimira Urbankova.

I have one maybe tricky question. During the last conference call, you mentioned that the news flow from the U.S. has been until now broadly neutral for the company, and there is no financial impact of the potentially adverse measures to talk about yet. Is there anything talk about now? How do you see the U.S. market now, especially your options, you mentioned that you want to expand there? How the current regulation will maybe shape your future plans in the U.S. and how it might affect potentially also your cooperation with AbbVie on Vraylar. So -- and yes, maybe sales of other products, et cetera, et cetera. I would very much appreciate it. And the next question would be rather technical, if you could give me some time line for expected denosumab, respectively, tocilizumab market launches.

Thank you, Vladimira. You're right to point out that the news flow from the U.S. deserves a comment because it changes every day, so there's always stuff to talk about. It's still very hard to gauge the impact on the U.S. -- changes in the U.S. regulations because there's still not a final set of new rules, new set of rules still not available, let alone implementation technicalities. So it's unclear. We had a 15% tariff a week ago with exemptions, which we don't know what they are. Now we have a 250% tariff being contemplated, let's say. And it's very hard to know where we end up. But the type of arrangement that we have with AbbVie is relatively well protected from all of this because we earn royalties from the collaboration, and there's a minimal amount of physical supplies that we provide. It's also unclear to what extent those physical supplies, the tariff content would have to be borne by us versus being absorbed by whoever, the patient, the insurance company, whichever stakeholder. So it's unclear. This is not the main thing. In women's health, the story is slightly complicated by the fact that our ambition is to provide European manufactured fertility, menopauses, contraception, et cetera, drug product for U.S. patients. The same is true for biotechnology. There are ways to address this if European manufacturing becomes a disadvantage and we'll be sure to take -- to make the most of those available options. Finally, in women's health, we also rely on royalties. For example, the Granata Bio collaboration is, to a significant extent, expected to be profitable due to the royalties that are owed to us, hopefully, in case of successful product launches in the U.S. market in fertility. I would also like to highlight that the evolution of prices in the U.S. is a big question mark. We have not come any closer since last time to understanding the impact of MFN or any other type of pricing strategy or framework on us coming out of the U.S. administration. So all we've heard about lately is tariffs here and tariffs there. And like I said, given the dominance of royalty-related income from our U.S. market access, we see this as less of a concern. The Deno and Toci time line may be best for Robbie to explain to you.

Denosumab, I mean, the brief answer is when LOE comes, then you want to be on the market immediately. So that means in Europe, in certain markets, hopefully, we will be there already by the end of the year. So late November, December. It's not going to be all markets and also shipments timing and schedule is highly uncertain. So we would not comment on any potential revenue contribution this year, but we definitely want to be in the first wave on the market with denosumab and then rolling it out next year. In the U.S., that's still contingent on the FDA approval. Tocilizumab, that's broadly contingent on receiving the approval from the European Commission. So if all goes well, then hopefully, first half next year at some point. And time is up. Thanks very much for being with us today. Unless Dawid, do you still have a question?

Yes, if you will be so kind to -- yes, one follow-up on Vraylar. Do you have any thoughts on the performance of the drug revenue in second quarter '25? I mean, this like double digit, if I remember correctly, 16% growth year-on-year was quite like improvement versus last quarters. And do you see any pricing impact right now? And do you think that like this double-digit base is like one-off or maybe kept in the rest of the year?

The assumption behind AbbVie's sales guidance for this year always been a double-digit demand or volume growth. So in that sense, yes, perhaps second quarter was a bit ahead of what was the original assumption, but was not hugely deviated from the original assumption for the market for this year. I mean what was the additional positive that, as Gabor pointed out, the Medicare part, the redesign impact is not yet there. So pricing actually was a small -- a minor positive in the first half, both in Q1 and Q2. So of the 16%, the tiny part was a positive pricing. So if anything from the Medicare reshuffle to come, that's going to be coming in the second half of the year. I mean -- and that was $200 million headwind as AbbVie quantified it a few months ago. Thank you very much. And with that, I think everyone is ready for lunch. So thanks very much again for your interest in our results and recent developments. If any questions you still have, then please reach out to Investor Relations as usual. Otherwise, I mean, have a great summer, and we see you in 3 months' time. Thank you very much. Bye-bye.