Good morning, ladies and gentlemen, and welcome to Gedeon Richter's first half 2025 conference call. My name is Róbert Réthy. I'm heading Investor Relations and ESG at the company. Today, it's my pleasure to welcome two of our senior leaders with me on this call, Gábor Orbán, our Chief Executive Officer, and László András Kovács, our Chief Financial Officer. Before we start the presentation, let me just quickly guide you through the usual technical details. We're 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, where you will have a chance to ask questions, either using the Raise Your Hand functionality of the Teams platform or using the chat box. Let me remind you that this call is being recorded. 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. With that, I would hand it over to Gábor Orbán, 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've managed to catch up with our guidance in the second quarter of 2025. 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. Clean EBIT grew by 15%. At FX adjusted, this is equal to the guidance rate of 10. EBIT itself grew by 11%. 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. 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 two points that we are particularly satisfied with. Both pertain to the innovative pillar of our operations. We now have two phase II trials ongoing with our RGH-932 neuropsychiatry compound. It's being developed jointly with AbbVie in two 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. RGH-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 a 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 are 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.
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. For us, these things are not completely foreign or alien. We look after the environment as much as, or well, not the same extent, but with equal dedication as we look after our operations. For that reason, we aim to make our operations production, so productive manufacturing infrastructure, and also the admin operations sustainable. We've made significant progress in doing that in two 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. This is the first year. 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. As a consequence of this, our own renewable electricity generation saw an increase of 60% in the first half 2025.
Secondly, we have entered into power purchase agreements, or one particular power purchase agreement with a three-year timeframe, 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 two help to significantly reduce the environmental impact, and improve energy supply, reliability. We're 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 tons of paper every year. We managed to bring that down to 70 in the COVID year of 2020. The challenge we were facing at the time was how to maintain those levels and possibly bring them further down. We had to redouble our efforts, and as of today, the number I can report to you from last year is 45 tons. 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.
I'm proud of the way that we have achieved all of this by relying on fewer and fewer external environmental resources. 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 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 HUF being weak translated into positive exchange rate effects on all 3 of the cross-currency pairs that we are exposed to, most importantly, the US dollar, ruble, and the euro. Those are the 3 most important exposures we have on the revenue side.
tailwind, the, let's say, push from the tailwind went down to about one half of what it was in Q1. Still was positive, it added up to a, to a nice positive impact worth more than HUF 10 billion. 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 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, even net of FX, growing at double digits. That's a remarkable performance. Menopause, endometriosis, and Drovelis. Oh, well.
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. Gen Med 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. 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. 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 HUF 200 million by AbbVie, the volumes and scripts grew double-digits ahead of expectations, which led AbbVie to raise their guidance on generally their guidance by HUF 200 million, which is divided between three brands, one of which is Vraylar. Which means that implicitly the Vraylar guidance is now higher by one third of HUF 200 million in AbbVie's outlook. This translates into royalty revenues for us, not to a degree that we'd adjust our guidance on the back of this. Still, there's upside to our Vraylar outlook in 2025. We knew that the Medicare changes would not affect the first months. Okay. Thank you, Robi. 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. Partly as a consequence of this, 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.
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 two compounds at the same time is an a cost intensive pursuit. Once the regulatory phase arrives, which is today, those costs will be lower, and that's the case today. denosumab's already been approved by the European authorities. The U.S. process is ongoing, and the tocilizumab's tocilizumab dossier has been submitted.
We are now in the finish, close to the finish line with those compounds. This is reflected in lower R&D costs. 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 cost growth did not slow down a bit more. It went up by 10%, about a third 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.
The composition of a clean EBIT is of course, once again, tilted toward neuropsychiatry, Vraylar taking the lead. 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, László Kovács, to discuss below-the-line items and cash flow.
Thank you, Gábor. Here, as usual, you can see a breakdown how we arrive 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 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. That's a massive difference. What is there behind? Here we have HUF 6.6 billion of unrealized gains, while on the realized part, we suffered HUF 15 billion. Why is that? In the second quarter, there was a significant depreciation of the U.S. dollar, and we had significant open open receivables coming from Vraylar and other accounts. When we make any changes, 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.
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. 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. The reason behind is DTA taxation. We had to build some DTA taxes for certain assets that we had tobe it on the group level as part of the acquisition from 2024.
We expect them to decrease by the end of this year. This is something that was still with us in Q1, and that will remain in Q2, but we expect that the effective tax rate will improve, getting closer to the end of the year. If we turn a page to the free cash flows, as Mr. Orbán just highlighted, we still have decent free cash flows, around HUF 121 billion. The lack of unrealized FX gain that was 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. 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 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. We think that altogether we are on track of following our annual internal CapEx caps.
Maybe a third thing that I would like to highlight is that, compared to the previous years, our other M&A is lower. Gábor mentioned Granata Bio and the Adalvo cooperation, what we had in the previous years. 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. As I mentioned acquisitions several times, I just wanted to share with you that the standalone financial statements of the Astretra business is showing a positive result as of the first quarter, which is totally in line with our expectations. We are collecting royalty incomes, we are collecting some milestones, and at the moment they are higher than the actual R&D costs that came up.
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. Some final thoughts from me on R&D and the progress we're making. In Women's Health, the Granata Bio contract's 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. 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.
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. 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 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 two 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 standalone 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 tocilizumab and denosumab launches in this year, late this year and next, so we're happy and looking forward to that. 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 General Medicines business.
The cardiometabolic 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, we're keeping at it. 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. There's continuous momentum in the pipeline in each of our four business units that which enable us to deliver our strategic goals in the next 10 years. This was it from us this morning. Now we're the floor is back to Gabi.
Yes. Thank you very much, Gábor. Now we are ready to take your questions. If you wanna ask a question, please use the raise your hand functionality or use the chat box. Happy to do our best to answer your questions. Okay. The first question is coming from Dawid Górzyński. Dawid, please go ahead, unmute your phone.
Hello. Thank you for taking my question. I want to ask about Women Healthcare segment. The first, if you could provide a bit more color on this increase in R&D costs in the second quarter, like, was that fully related to this new site in Belgium? Am I right that this, like, from the acquisition, like, concluded last year or maybe, like, some other, like, project? If this, you know, level in second quarter is a good run rate for the future?
The second, on Women Healthcare, as well, like, in the Excel file that you disclosed, you, like, no longer provide, like, you no longer, like, list oral contraceptives within key products in Women Healthcare. I wonder why you, like, decided for such change right now. Thank you.
I start with the second one. Actually, we didn't stop providing data on contraception. We changed the structure of disclosure in line with how we presented our strategy and how we are managing the business. Now you can find on the data sheet, on the Excel data sheet, data file, in Women Healthcare a breakdown of sales by therapeutic areas, and contraception is clearly 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.
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. 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's of course an allocated amount coming from the maintenance work and all the rest of it from within headquarter, but that'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. 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. That work is ongoing. 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 three components of those costs in Women's Health R&D, even four components. Our CFO will know hopefully
At the moment, I wouldn't take it as the 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 project, then the rate could be higher. Everything that happens is completely in line with our internal budget, so there's 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?
Yep. 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 course that we will account under Women's Healthcare which we are doing in cooperation with our partners. That is what you might expect there.
Yeah. Thank you so much for this call and the take on the oral contraceptives.
Thank you very much. Next question comes from Bram Buring. Bram, the floor is yours.
Yes. Hello. Do you hear me?
Yes.
Yes.
Excellent. Okay, just a few small questions, please. Yeah, you mentioned that We saw that impairments in for inventory and 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 this, 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. 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. The second half of the year is expected to deliver the reduction that was foreseen for the full year.
Okay. Thank you. 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. 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. This isn't a molecule that we've seen, as it were?
No. No.
All right. This is something new.
The one what Gábor mentioned, which may potentially move into phase II, and currently in phase I, that's a CNS, that's a standalone CNS project, unpartnered for now.
Right. Gotcha. Yeah, I'll drop out of the queue. Thank you.
Thank you very much. Next question from Gábor Bukta. Gabor, go ahead, please.
Hi. Thanks for taking my question. Thank you for your presentation first. You mentioned at the beginning of the presentation that you are proud what you achieved this year. To be honest, I'm a bit disappointed when I attempt to look behind the current developments. You implemented a strict cost control, but I see, especially in the women's healthcare and General Medicines segments, that the gross margin declined on a year-over-year base, and I'm just wondering if it was coming from a mix of adverse impacts or what has happened. The second question is with regard to the impairments. Have you seen any kind of or sort of similar patterns in July or in August or is it possible that you have to impair some more assets going forward?
What's the reason behind this move? Thank you.
Thank you for your questions. On the impairment first, this is technically may be an impairment, but it's really inventory write-offs. 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. It's not asset impairment as such, like an intangible or whatever. We are quite confident that in the first half we have absorbed the shock and let's say swallowed the pill to be very stylish. 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. 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. 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 my introductory comments. The strong base, unfortunately, was strong.
Unfortunately, it's a matter of perspective, but it was strong in the gross margin sense also. It was even stronger than the average, meaning those pre-shipments in Q2 2024 happened to be from among the highest margin products. If the margin was strong from a revenues point of view, 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, that's the point. Q2 last year, pre-shipments were highly profitable products.
Thanks, Gábor. But if this is inventory write-off, this a more serious issue, I guess. I'm just wondering when you recognized this, could you fix it? Is there an internal or external pressure or issue?
Yes. Inventory write-off had to do with non-compliant starting material coming from one of our European suppliers. I'd like to blame it on someone, but I cannot. The problem has been fixed, and the market stock out is also addressed. We have identified improvement points and acted on this to minimize impact. That said, the manufactured batches are non-compliant and had to be written off. Yes, it. This is in the past.
Gábor, 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. 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.
Okay. Thank you very much.
Thank you very much. The next question comes from Christopher Richardson. Chris, over to you.
Good afternoon, gentlemen. 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. Is this early-stage customers? Is it perhaps a funding issue? 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. Just if you had any sort of high-level commentary on that. Thank you very much.
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. We, 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. That's what the comment was referring to. 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. 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. Given the imbalance between interest and capacity that we have had over the years, I don't see this as a major threat. Because so far there's been an order flow which the industry could not accommodate. 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. Rubi maybe you can help me out.
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. Even though we have decent growth, we still had some constraints in terms of our partner supplies. The reason for that was that we had to prioritize capacity because not only the RM being 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 that is NX1 related. Therefore, capacity was actually not fully available to satisfy 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.
Yeah. The question, it's based just on the comment in the presentation that the gross margin was perhaps slightly inhibited because of lower than expected volumes.
Yes
costs of sales.
Mm-hmm.
Okay.
This is exactly-
Maybe just. Okay. Just sneak in a last one just on denosumab. I'm wondering, are you targeting the Prolia or the Xgeva indications out of interest? I know you're approved in all of them. I was wondering if there was a preference or one indication you're seeing is more sticky potentially for the originator than others.
In Europe, I mean, we are approved for both. In Europe, I mean, legal both for both indication. We want to be in the market for both. In Europe, we are approved. In the U.S., it's under review.
It will be different in each country within Europe, how uptake will evolve. They're distributed in different channels. One more in the hospital channel, the other one maybe more prescription-based outpatient. 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. 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. Still, in some markets, we expect that product to be more successful than the other one.
Awesome. Thank you.
Thank you very much. Next question is coming from Vladimira Urbankova. Vladimira, please go ahead.
Yes. Hello. 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 to 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 bill maybe shape your future plans in the U.S. and how it might affect potentially also, you know, your cooperation with AbbVie on Vraylar, and maybe sales of other products, et cetera, et cetera. I would very much appreciate it. The next question would be a rather technical issue.
Could give me some timeline for expected denosumab, respectively tocilizumab, market launches. Thank you.
Thank you, Vladimira. You're right and 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 or a new set of rules still not available, let alone implementation technicalities. It's unclear. We had a 15% tariff a week ago with exemptions, which we don't know what they are. We have a 250% tariff being contemplated, let's say. It's very hard to know where we end up.
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. 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, menopause, 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.
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 denosumab and tocilizumab timeline may be best for Robi to explain to you.
Denosumab, I mean, the brief answer is when LOE comes, you want to be on the market immediately. That means, in Europe, in certain markets, hopefully we will be there already by the end of the year, late November, December. It's not gonna be all markets, and also shipments timing and schedule is highly uncertain, would not comment on any potential revenue contribution this year. We definitely want to be first wave on the market with denosumab and rolling it out next year. The U.S., that's still contingent on the FDA approval. Tocilizumab, that's broadly contingent on receiving the approval from the European Commission. If all goes well, hopefully first half next year at some point.
Thank you very much for answering my questions.
Thank you very much. Time is up. Thanks very much for being with us today. Well, unless Dawid, you still have a question.
Yeah, if you be some kind, so kind to, yeah. One follow-up on the Vraylar. Like do you have any thoughts on the performance of the drug, revenue in second quarter 2025? 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? Do you think that like this double digit base is like one-off or maybe kept in the rest of the year? Thank you.
The assumption behind AbbVie's sales guidance for this year always been a double-digit demand or volume growth. 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 Gábor pointed out, the Medicare Part D redesign impact is not yet there. Pricing actually was a small, a minor positive in the first half, both in Q1 and Q2. Of the 16, a tiny part was positive pricing. If anything from the Medicare reshuffle to come, that's gonna be coming in the second half of the year.
I mean, that was $200 million headwind as AbbVie quantified it a few months ago.
Okay. Thank you. Perfect.
Thank you very much. With that, I think everyone is ready for lunch. Thanks very much again for your interest in our results and recent developments. If any question you still have, please reach out to Investor Relations as usual. Otherwise, I mean, have a great summer and we see you in three months' time. Thank you very much. Bye-bye.