Gedeon Richter's Q3 2025 earnings conference call. My name is Róbert Réthy, I'm Head of Investor Relations and industry. As you probably noticed, there is a slight change in the lineup for today's call. The reason is fairly simple. Our CEO Gábor Orbán is not able to participate in today's call because he's en route to Washington D.C. He is part of the team of our Prime Minister who is heading to D.C. to meet President Trump tomorrow. This probably doesn't come as a surprise given the very important role that Richter is playing in the business relations between Hungary and the United States, especially when it comes to high value R&D driven activities and trade relations. Of course, on the other hand, this created a bit of a necessity for us to reset our plan for today.
So instead of Gábor today we have with us Tamás Szolyák. For the first time in this conference call, he's the Chief Commercial Officer and of course László Kovács the Chief Financial Officer. And I'm highly confident that quality of this discussion will not suffer from the absence of Gábor. Before we start the discussion, the usual technical details I'd like to go through. We're doing a formal presentation using the slides what we published this morning along with the earnings and the Excel data sheet. After the presentation there will be a Q& A session and as usual you will be able to ask your questions either using the raise your hand functionality of teams, Microsoft Teams or putting your questions into the chat box. Two more things.
This call is recorded and also I would like to draw your attention to the cautionary statement at the end of the presentation about the forward looking statements which this presentation and this discussion may include. With that I hand it over to László who will discuss the financial results and then Tamás will go through the the revenue, the top line developments.
Thank you very much Robbie. Good morning to everyone. We will be stepping in for our CEO Gáb Orbán for today and we'll do our best to provide you with his perspective and to ensure that we cover all the important points. I think in this quarter it's particularly important to look a bit behind the numbers because what you see in Q1- Q3 there's a temporarily slowing dynamics in the third quarter and overall I can say that the quarter was mixed. The strong growth across the innovative businesses including Women's healthcare and CNS continued. However, it was contrasted by multiple headwinds in the affordable segment both from Biotech, CDMO and GenMed were impacted by internal and external challenges Let me start with CDMO where the performance was constrained by the U.S. market regulatory uncertainty limiting the inflow of new deals.
While technology related issues in our German side caused some further pressure during the ramp up period. On the other hand, GenMed was really faced a series of hits. First of all there was supply chain stock outs problems affecting one key product. Then we noticed wholesaler destocking across several markets and we had an extremely high base back in Q3 2024. This mixed effect at the top line was partially compensated as we applied very strong operating cost controls, limiting the impact of the weaker top line on our profitability. Right. So rather than being one of cost cutting measures, this is rather a reflection of the benefits of our long standing corporate efficiency programs that we run in this company. Now if we take a look on the color scheme of this slide, you may notice it's pretty similar what we saw in H1.
However the indicators remain the same but the numbers are more moderate. They're close to 7% growth in nominal terms including pharma sales, Clean EBIT and [EBIT figures]. The FX adjusted figures are a bit even lower, but the difference between the FX adjustment and nominal values are getting closer. Both bottom line indicators show slight decline driven entirely by by adverse ethics dynamics and taxes. The swing between last year's ethics gains and this year's losses is close to 30 billion Hungarian foreign. Free cash flow however, clearly stands out here. We managed to follow our CapEx controls and networking capital was favorable during this quarter. So we are able to report an all time high HUF 200 billion here. So what does this picture mean for the rest of the year and further ahead?
First of all, we strongly believe that the Q3 revenue shortfall is temporary in nature, but we may not fully return to our previous baseline and growth in Q4 yet. As a result, now we see that our full year revenue on constant exchange rate will be approaching EUR 2.3 billion, which is around the lower end of the range we have previously given to you. On the other hand, we continue to expect profitability to visibly improve in 2024. Now we will use all of our tools at our disposal to make sure that we can expect a constant exchange rate clean EBIT growth in the region of 8%-10%.
Given the strong, very strong cash flow generation, we also expect to be in a position to continue to further increase our regular dividends fully in line what we shared with you in our capital allocation framework back in March. Now I'm handing over to Tamás to share a few thoughts on the top line.
Thank you very much, László. Good morning everyone. As you can see from our numbers or Q3 performance basically hindered a bit of our growth rate. Right now we are sitting on a mid single digit growth year-to-date. If you look into the regional setup of this growth, we do see that Western Europe, North America and Asia Pacific has very good results. We are kind of proud to see that Western Europe is growing fastest right now. Around 12.7% year-to-date growth. What we could recognize in that segment and North America and Asia Pacific as well, very high single digit, close to 10% but still it was a single digit altogether.
This segment reflects very well that how.
The innovative portfolio is performing.
On the other side in Central Europe.
Eastern Europe we had a much lower growth.
What we achieved, we were basically prepared.
For this slowdown altogether due to the fact that we've seen the impact from last year a higher base mostly. As well, we have seen some of the trends and activities what we initiated recently. From that perspective, the slowdown of the growth of the Central European markets very expected.
Taking into consideration the exchange rate, the tide has been changed.
From the first half year in Q3.
We had basically a headwind. It was mostly due to the weakening.
Dollar and the strengthening Hungarian forint.
Altogether Q3 as you see here on the full portfolio we had a bit.
Of a drop of sales compared to last year. Quarter three, year on year comparison and I think it is good to look into the details. Thank you Robbie.
So first of all we would focus on the innovative business part mostly from female healthcare which is very important to recognize that quarter- on- quarter growth of the women healthcare portfolio was 11.7%. So the portfolio growth did not slow down at all. Our key products again quarter- on- quarter, Ryeqo , Drovelis and Lenzetto all of them achieved growth above 60%. So it is still a very dynamically.
Growing portfolio for us.
Contraception the growth is mostly driven by Drovelis. This is fantastic. We still see a very big long term potential in the product. The emergency contraception had a little dip in Q3 mostly due to the fact that we needed to reschedule some of the deliveries to the U.S. and to the Chinese market which was on the other side a positive development that ever portfolio strengthens as we could complete our tender deals in Mexico. Fertility business, important therapeutic area. It's getting back and taking back its market position. However it takes time, it's a bit slower. We have seen some supply chain challenges for Bemfola in the LatAM region. Uterine fibroids and endometriosis. This is one of the center in the center of the key women healthcare topics. As we do see right now or patient centric approach.
It is important to see that how we are really improving the access for all innovative therapeutic options for women in this territory which in the past did not have good solution. Ryeqo is flying on. It performs excellently and it's providing an efficient and safety option for our patients. And menopause portfolio growth is mostly driven by a strong patient demand which is completely understandable because that issue is hindering significantly the quality of life of the women. And this is a kind of trend change. What we do see as well in the professional community because they are focusing more and more on this territory. We do see as well more and more investment coming back to this territory in menopause which reflects as well the future potential of the women healthcare portfolio.
And we have a really robust growth for Lanzetto going to the CNS business part. Vraylar 6.7 growth 934 million USD sales in Q3 year-to-date growth is double digit. This we quote from the reports of AbbVie. We would love to focus to our own performance which might look bad based on the figures you can see. However, we need to know that all markets which is managed by Richter still have a double digit growth. Managing this product on the old premises or partnering slayers a bit slow down. But this was mostly shipment issues. And we are absolutely confident in the performance because we do see that the market performance is not a high single digit. The middle or low single digit growth is provided throughout the years. So we do see that the Q4 numbers in the CNS portfolio will improve.
General Medicine this was the trouble Charlie Non business unit Setup for the Q3.
Results.
Decline we suffered on quarter by quarter comparison in 17%. As I mentioned to you, we partly were prepared to have a weaker growth of this portfolio. It was mainly made mostly based on the issue that in the last year in September Hungary we had one of positive impact which increased our basis rather significantly. Together with László, we are working very heavily to manage the working capital on a better way. It's a high focus right now with that one. We turn with managing our customers especially in the traditional markets with a higher rigor. And it has an impact when and how we can supply them with products. And that caused another negative impact. And we calculated when we looked to the Q3 numbers in our films there were some other element.
Many of the traditional markets has a typical pattern of the quarterly sales Q2 is regularly rather high which is followed by a weaker Q3 and Q3 the wholesalers regularly destocking. This year this magnitude was much higher than we anticipated. And there were another meant that in September we were already much better prepared how to handle the usual stockpiling of the wholesalers. And we managed it with a much more financial rigor compared to the past years. And it had an impact. One of the most important impact is that the leading product of our affordable portfolio Mydeton/Mydocalm t olperisone suffered a supply issue and significant stock out problem. This was basically high value, especially in September. We already seen some impact in August but September was critically hindered by these supply issues. We do see that it will unfortunately hit October as well.
We will stabilize the sales through in November. So from that perspective we expect a gradual recovery from the supply to the markets of tolperisone few crew four. Another negative element was the Kazakh market where legislation change pushed down the market and the wholesalers they were destocking from four month stock level. They went back basically to a three week stock level. This happened again in the third quarter. All of these impact arrived to us basically parallel and therefore compared to the expectation we finished the Q3 on a lower level. And and all of them what we try to manage resulted a kind of a weaker performance. What we could see on the other side that the market sales did not suffer that much at all. We were basically throughout the year stable. We suffered an open 2% market share loss in the respective markets.
In the traditional markets. What I do see and mostly it comes this loss from the impact of the Mydeton sales. And therefore we are confident that the base performance of the general medicines business unit is kept on the market. And we do see that gradually we will gain back and build back our position step by step in that portfolio business unit revenue. It's again two part what we have to look for. One is the teriparatide sales. Altogether the growth is 6.1% and teriparatide year-to-date growth is 9.5% in the quarter. In Q3 we were able to grow still 5.1%. So the teriparatide business altogether goes very well. We have seen some slowdown due to how we are managing the supply. We were deciding to move some of the supply to the partners later into Q4. However.
However the markets we are managing performed very well with teriparatide on the other side. The CDMO especially quarter by quarter presented a different number. - 12% drop. This was basically due to the factors that in the very beginning of the year we had some technical issues. These technical issues actually delayed production for several months. Few batches. What we can we could manufacture in this time compared to what we originally planned. And all of these manufacturing had been shifted backwards due to Q4. We are working very hard. We condense production. We are looking for a significant improvement and most of the deliveries which already contracted will be managed to accrue for we have a very clear focus on how the company is performing from that perspective. And looking on monitoring, testing and release times.
We are there that there are some macro factors which already have been mentioned by lots of tariff on certainly tighter capital availability from the U.S. which caused that some of the project has been postponed. Customers looking to adjustments in the contracts. However, we manage it proactively. We already secured some new development service and even more we have a new European biotech company contracted recently. So we do see that the future.
Is getting back for this portfolio as well.
Looking ahead for Q4, we believe that the Q4 results will go back again. We aim to achieve around double digit growth quarter- on- quarter, year by result, year- by- year results in Q4. Basically the above mentioned factors as you could have seen were mostly one off factors and issues what we already handled. Therefore we will go back to the trajectory where we've been with Biotech and Gen Med and we absolutely trust that the women healthcare portfolio growth will fly.
In the last quarter as well.
Thank you. On the operation cost side, we finally see some of the effect of the efficiency programs we have initiated in the recent years. This was combined with some timing effect and some further cost controlling measures that we applied year-to-date. COGS figures is relatively unchanged with Q3 showing some slight increase. This is a direct effect of the lower sales volumes because fixed costs were borne by fewer products in the end and that short time horizon of three months, there's no real space for management intervention. I think what is the most important here is research and development costs. You can see a decline here which is mainly due to the fact that our biosimilar portfolio reached some major crossroads.
Now, by releasing four products and three molecules over the course of the next 12 months, we can mark that an era of major investments into Biotech R& D has now ended. You can see that the average quarterly spending of biotech decreased by over 20% while CNS and GenMed is broadly unchanged in nominal terms. This is a well planned and deliberate change to our R& D cost structure which was created to have some space for women's healthcare internal innovation which is about 10% higher than in the past year. The third quarter however were below the normal run rate. This is a result of timing issues and some accounting driven adjustments what we had in Q2. So we may even maybe not be able to appropriately foresee the quarterly speeds.
But at the moment we are very confident that in the year end the lending will be there where we want. So the Q3 figure will be at around or up to EUR 20 million for women's healthcare. And looking further ahead, the quarterly run rate could be at around EUR 20 million- EUR 22 million per quarter, which will provide us with a solid foundation for disciplined investment and sustainable innovation in women's healthcare. Both sales and marketing and GNA figures show reasonable 8% year-to-date growth in nominal terms. The later is also boosted by the acquisition we had in the previous year. Now, as a result of all of the above factors, if you turn the slide to Clean EBIT you can see that we have delivered a Clean EBIT of HUF 66 billion in the third quarter which is down by 7%.
But the Q1 Q3 combined year-to-date number is 7% up reaching HUF 213 million altogether. Let me emphasize that our innovative business units were the main growth drivers delivering a combined 10% increase in both quarte- on- quarter and year-to-date. This is a notable achievement given the significant US dollar headwind in Q3. The Q3 decline reflects multiple top line headwinds in GenMed as it was just explained by Tamás as well as CDMO businesses where we saw the 12% decline in top line also having an effect on the bottom line. Looking ahead we expect a substantially better performance in all business units except for CNS which was remarkable as well. So in Q4 we expect the substantially better performance and the full year constant exchange rate. Clean EBIT is projected to grow between 8%- 10% compared to 2025.
Maybe one more thing to highlight here is that the in market sales in all segments were in line with the market trends. This gives us further encouragement that we will achieve what we expected. If you look a bit below the line then you can see the difference between Clean EBIT to EBIT and then to net profits. There are two notable points here. One is the massive FX losses that we suffered especially in the last two quarters which is provide us with accumulated HUF 24.7 billion losses compared to HUF 5.8 billion gains one year before. And taxes we pay more than HUF 33 billion . You know this is the second year with the global minimum Tax regime. Now this year we have some additional deferred tax expenses as a result of the acquisition.
Only good news, with deferred taxes, this is something you don't need to pay, but still it erodates our profits. If you're taking a look on our cash flow, you can see that free cash flows reach the all time high. HUF 200 billion this is for the first time in nine months and this is 22% higher than a year before. This is a very strong performance that was driven by higher operating profit, lower CapEx and the much smaller build in working capital compared to the previous year, which is to some extent a result of our actions and to some extent to the missing top line.
What we have in Q3 beyond the regular annual dividend of HUF 93 billion which we paid in Q2, there were only minor transactions that required cash, meaning that most of the free cash flows added directly to our net cash position. Let me highlight that recently we were close to finalizing two sizable potential acquisitions in women's healthcare, having been shortlisted at the last round of the bidding. Unfortunately none of them went through. But we remain very much disciplined here. So we will follow our M&A strategy and approach pursuing only assets and businesses that clearly align with our strategy and adds value. So we will not make any acquisition just for the sake of spending additional money. One more slide I would like to discuss is research and development. First of all there is no major changes in the pipeline with AbbVie and in CNS.
We are absolutely on track. 932 is in phase II clinical trials with two indications and the expectation remains the same that by the end of next year we expect to start the first phase III clinical trials. So this is extremely good news. We have one phase one project which is our own project 202 and nothing to report here. We expect that we can go through to phase II trials later on. I would like to highlight that denosumab, our molecule in biosimilars, is being launched as we speak in some of the Eastern European countries and we expect further blood and cardio launches in the CE region in Janmad. And I think altogether that is what we wanted to share with you in a nutshell. And we are here and ready to receive some questions from you. And I'm handing back over to Robbie.
Thank you very much László and Tamás and ladies and gentlemen, we are now open to take your questions. So as I mentioned, either raise your hand function or please put the question into the chat box. So first question is Coming from Gábor Bukta Gábor, please go ahead.
Hi, this is Gábor. Thank you for your presentation. First of all, I like to ask question about the Gen Med business because you mentioned during the call that regular recovery in supply to the Eastern European markets or Russia is expected for Q4 and just wondering when it will normalize so at the end of Q4 or in Q1 next year. And another question regarding GenMed that do you face any production issues which have already resulted in a significant impairment in Q2 or what we can see here in the future? And going to another topic, frankly speaking, when I looked at the Kustof Gotz trajectory I was very disappointed and you mentioned that it was around flat and you see some positive improvements on the cost side also.
But excluding the CNS segment, the gross margin stood at around 36% in our calculation compared to 43% in the first half of 2025. And where do you see the gross margin in the four quarter of this year? If I can touch on the R& D side, you mentioned that 2022 million euro run rate on a quarterly basis is expected in the women's health care. But can you give more color on where the 2026 R&D spending will land? And the final questions if I may ask about the M&A strategy and I'm just wondering if you want to acquire a product or a small company with any kind of original platform in the future.
Okay, thank you. Good bunch of questions. We'll try to answer them. So let me start with GenMed. So we expect that Q4 will be stronger than Q3 but will not be on the normal run rate. So we maybe need an additional quarter. But here Tamás, please make some further comments as you feel appropriate.
I just would add one part that the major stock out issue will be handled throughout Q4. Q1 will be already normalized. Q4 is impacted mostly by October, somewhat by November. December is always a different month we all know. But by Q1 from that perspective we will be fine with the major Mydeton stock out issue.
You also asked for production issues. I would call out Mydeton in this respect which was we mentioned back in August that we had an issue with the starting material which affected production. So that was one major issue that went through parallel to this one. But I would somehow separate CDMO because and this is also links somehow to your COGS question because in CDMO in Germany we had some technical issues in the ramp up. It's a very very complex production. If you have anything with Those cell lines, it's not something that you just fix a screw and it will be fine. It takes months. So that is a separate problem that we face. But except for these we don't see any production issues. Maybe on the other hand we increase some of the internal efficiencies here in Budapest.
Clearly on the COGS questions, maybe I will also ask for Robby because I was not able to fully follow through all the numbers you shared. But here there's one very important thing. So if you just take out CNS and Vraylar in itself has like 99% COGS rate still you need to make some further distinction between biosimilars and CDMO because the CDMO business reports a low gross margin rate. But basically there's nothing more than gross margin, only some G&A cost. So the gross margin almost equals to the net Clean EBIT profit. So besides that I also see some slight decline. Was women's healthcare partially due to the production mix and it was around 1.5 percentage points.
What I saw it was partially because of posting or one of our products sold in the Chinese market which has a very high gross profit rate, really extremely high. And now Tamás mentioned the financial rigor. It's not a secret that we changed one of the distributors and major shipment was due this at the end of October. So this has an effect. And some of the growing products like Drovelis, it's normal that in the in this rate or in this life cycle it has a bit lower margin rates than when it's full scale on R& D. The 2022 million I mentioned with the 2026 expectation. Let us come back at the end of February when we have the year end figures and we provide you with the full year guidance. If you just give you a hint.
If I give you the number run rate and what we had in GenMed and CNS you can pretty much figure out. But we'll discuss it in more details in early 2026. With M& A and M& A strategy, I can highlight what we had here. So first of all, it could be either assets or businesses. But in the past we were more successful with assets. It's easier to find because it's not that easy, but it's still easier to find assets that fits into our portfolio. And we have very good track record in acquiring assets and embedding them to our daily operations. And it's easier to find similarities because our strategy is based on therapeutical areas.
If you buy a company, there's no guarantee that it will be only focusing on the same therapeutical area for buying anything, more like a company for having R& D expertise. I don't see that happening because we just did it a year ago. We acquired the old Mitra part. This is called Estetra, this company we hired some further really, really black belt R& D people there. So we feel that we have enough muscles to do the exercises.
Thank you very much. I hope we answered most of your questions. So basically in terms of cost of goods sold and gross margin, definitely going into Q4 based on what has commented, we expect COGS to decline and gross margin to improve basically across all three segments excluding CNS as you asked. So next question comes from Bram Buring. Good, go ahead.
Hi. I'd like to touch on the cost efficiency point that you had made earlier. Probably not seeing you said you're seeing some improvements there and I assume that they will continue into 2026. I guess my question is where are we really going to see which lines are we going to see these efficiency measures most strongly? That would be the first question and then the second question with the, with the BIO you mentioned the technical issues and these technical issues are to do with the CDMO or to do with your own production or both. If you could go into a little bit more about that. Finally you also flagged less than successful launches of some new GenMed drugs. If you can add anything there and if anything has changed in the, in the fourth quarter or you expect it to improve in 2026.
Thank you, thank you very much for the cost efficiency programs. We try to give you some hints back at the capital markets day that where we would like to improve and this was namely sales and marketing efficiency. Absolutely. Admin costs typically G&A, but we have admin costs in other buckets as well and the normal run rate of R& D. So these are the areas that will be affected at sales and marketing. We just would like to sell more with the same level of cost basically. Tamás, if you would like to add any comments on consensus and marketing please.
Yeah, happily actually lots due to the fact that we are focusing very much on the salesforce effectiveness right now, building a new approach, how we run the sales forces in the countries, how we work together from that perspective with the countries, how we can improve the performance of the sales forces attached certainly to the marketing strategy, what they have to implement and if you don't mind, let's see. I'm jumping back to the last question with that perspective. Where we suffered most in GenMed, this is the blood and metabolic Therapeutic area. We had recent launches there and for different reasons in different countries, not on an even way. We suffered kind of lack of performance with these launches. It was in some countries due to the local generic competition which proved to be much stronger than our capabilities, especially in Russia.
In other cases in Romania, in Poland, we realized that we need to do a better job. How we are preparing for our launches, how we are deploying the salesforce out in the markets, how we are preparing ORSA for the straight channel management in line with the salesforce promotion.
These are territories where we recognize the improvement opportunities. This is already in place.
If implementation from these steps, we basically expect a further improvement of a return on investment into all marketing and sales activities. I hand back to you if you want to answer the biotech.
Yeah, absolutely. Thank you. And maybe just one more comment to cost efficiency. So if you just take a look on the P& L itself main needs going to be sales and marketing and G&A. With R& D it's a bit more difficult because when we speed up some of our spendings then you will not be able to clearly distinguish what is efficiency and what is really some increase of actions with biotechnology. Yeah, let me be clear here. It's CDMO, it's Germany. It's one side and one line. So it's a very, very separated issue. Nothing to do with the operations here in Hungary, in Debrecen that we need to be very proud of. And maybe I just missed the opportunity to highlight that we are the very first company in country and region to get the first FDA approval of our site.
We went through nine different examinations. You all know the drill and we did it and we are very happy and very proud. So scientifically and technically we are good. We have this extension project in CDMO in Germany, in Bovenau and we expected more revenues coming in. But due to these issues, we will record most of those revenues in Q4. Hopefully next year will be about really expanding not just the capacities but the revenues. This is my expectation as a CFO.
Can I have a follow up on the CDMO question? So, all right. You flagged before issues with U.S. customers. You say that you proactively, you know, made the, made adjustments to the value of those contracts. You have a new customer. So just generally for 2026, if, if you'll go that far, should we expect CDMO to improve on the 2025 run rate or is it going to be at a lower run rate because of changes in contracts with U.S. customers?
Okay, you know I would. So let's with next year guidance. Let's. Let's wait until the year end numbers. But. But altogether what we see now hopefully is a turning of trends so we are positive about Q4 and let's see what we can put confidentially or confidently. Sorry, interguidance for next year.
Thanks.
Thank you very much. Next question comes from Dawid Górzyński. Dawid, floor is yours.
Hi. Thank you for taking my question. I actually also have three questions so maybe just take them one by one and the first one is follow up on efficiency gains that you achieved. And when I look at sales and marketing costs this year, sorry, this quarter it was generally flattish year- on- year and I wonder like what part of that was related to just lower revenue in some units, especially in general medicines. And what part was this cost efficiencies.
Thank you for the. Thank you for the questions. Of course some of the variable costs was definitely attached to the lower top line numbers. On the other hand, as we do the promotions and the fiat for the activities. Sometimes you need to make these investments before and then you see. Or not sometimes, always. Then you see the potential returns. I'm not able to provide you with an exact number on this, but it's an identifiable difference from the internal management accounts that is related to the first run of efficiency programs and we hope that more will come in the course of the next quarters. 2026.
But it's fair to assume that sales is picking up again then or surely SNL expenses will be picking up too.
We won't be able to have higher revenues with flat sales and marketing but the ratio needs to improve and this is what we see internally some improvement is there already.
Aerobit, this is kind of a system when you expect always your shares is growing much faster than your investment basically and then this is what we are working for. That's where we look to efficiency improvement on this territory.
Okay, thank you. Second question on R& D costs. I just wanted to confirm if I understood correctly that the run rate for for women healthcare segment in terms of R& D cost is 20 million. EUR 20 million-EUR 22 million .
Exactly.
Yes.
That's what we expect next year. The last quarter it's up to 20 million. This is how we see it currently, so it's lower, hopefully lower than 20 in Q4 up to 20 million and 20 to 22 in quarters after that.
Okay, thank you. The third one on Vraylar O2 project. I also just wanted to confirm that you expect phase three to be started in next year because I'm just a bit confused because I thought that AbbVie just guided on the recent call that results of phase two may be delivered only in 2027.
No.
That's the second indication what they commented that may slip into 2027. So the GAD, which was launched in May this year as the second indication where phase two trials are running, AbbVie still, as far as I know, still expect the first indication, bipolar depression to if the results are as we and we expect justified, then to start phase three by the end of next year in BD bipolar depression.
Okay, thank you so much. That's all from my side.
Thank you.
Thank you very much, Dawid. Next question comes from Sophie Thumfart. Sophie, go ahead.
Hi. Thank you very much for the presentation. I suppose. Could I just come back to R&D please? Are you able to give us some kind of guidance at the group level, perhaps as a percentage of sales? I appreciate what you've given us for women's healthcare, but it would be helpful to understand how it will trend going forward in the other segments. And then just really briefly, how confident are you in receiving a patent extension for pediatrics for Vraylar?
Okay. With regards to any pediatric issues, AbbVie is leading the discussions around the topic. I have to refer to them to respond on that one with the run rates. You know, the one answer that we are very, very strict with is to make sure that all combined R&D spending cannot exceed 13% of revenues ever. That is our commitment. What we did with the strategy, what you could see here or what you could expect that biosimilars will be on a lower run rate. Definitely this year was the turning point and next year we don't expect to have an increase. We are really focusing on the market now. 2026 is the year when we have all together with teriparatide that we have five products on the market.
It's going to be more about trying to bear the fruits of that investment. With GenMed when we declared our strategy, we also remain committed. If needed, we put some further money into R&D. Now you couldn't see that big increase in 2025, so there might be some further increase. But it's always a question if we are doing our own developments or we are teaming up with someone else. You could see some examples on that one. Women's Healthcare, we commented and in terms of CNS, definitely our cooperation with AbbVie is running fine. So if we can start phase III next year, definitely there's going to be some increase. But that is an increase to the good.
We'll be very happy if we can spend money on phase three examinations, partner with AbbVie on a molecule that has good chance to be realized to the toe.
For any given year I think the level of R&D is very much going to be or always going to be project driven. In CNS, depending on the progress of the molecules in particular 932, but also 202 and in Women's Healthcare, depending on our ability to bring in projects externally and to develop our own very early stage molecules in the coming years.
And maybe just one addition to give you some, some hint on that, that we also started an efficiency program on fixed costs. So you will always see the combined figures. So that is what we would like to gain efficiency with the fixed cost, keeping them as tight as possible and you know, having the room for the programs. That's why at the very moment it's very difficult to give you an exact run rate for all business units for next year. But definitely we'll come up with the guidance early next year.
Fair enough. Thank you so much. But you will not exceed 13% of sales, is that what you said?
Absolutely. That's the red limit.
Okay, cool. Thank you.
Thank you very much. I don't see any further questions at this point. So if there is no one else wanting to ask the question then Michelle, thank you for your participation and for your questions. If there is anything else which we can help you would then please reach out to investor relations and otherwise we will see you in three months time with a full year results. Thank you very much. Have a nice day. Bye bye.
Thank you very much. Goodbye.