Good morning, ladies and gentlemen. Welcome to Gedeon Richter's conference call, where we plan to discuss our first nine months' results. My name is Róbert Réthy. I'm Head of Investor Relations, and it's my pleasure to welcome to this call the usual lineup of senior management: Gábor Orbán, our Chief Executive Officer; István Hamecz, our Chief Financial Officer; and László Kovács, our Head of Controlling. Before we start this presentation, let me just share with you a few technical details, as usual. We're going to be following a normal presentation using the slides that we published this morning and what is accessible on our website, gedeonrichter.com. After the formal presentation, we will be holding a Q&A session where you will have a chance to ask questions from management using the Raise Your Hand functionality of Microsoft Teams or through the chat function.
Also, please mute your microphone during the whole duration of the call, except when you are asking a question. And please note that this call will be recorded. Also, as a last comment, I would like to draw your attention to the cautionary statement on the last slide about potential forward-looking statements during this presentation. And with this, I would like to hand it over to Gábor, who will walk you through the numbers and the details of the last three months.
Good morning, everyone. Thank you very much for joining our earnings conference call this morning. We have another decent quarter behind us. I'm happy to report that the underlying trends are broadly intact. We see a very similar picture compared with the first six months, which we discussed in early August. The numbers are higher, considerably higher. All of our revenue and earnings lines grew double digits compared to the same period last year, both FX adjusted and the headline figures. Pharma sales are up by 14.5%. Clean EBIT, the indicator which we watch the most closely, is up by 19%, and EBIT is up by close to 32%. I'm also very pleased to see free cash flow up by close to HUF 100 billion compared to the same period last year. Our guidance, our goals this year are still within reach.
If we look at non-FX adjusted figures, I'd say comfortably FX adjusted, we are closer to the lower end of the interval that we provided in February. There are a number of reasons for that. I will walk you through those factors that have influenced our numbers in recent months. It's important to note upfront, however, that a lot of the changes to the outlook have come about as a consequence of the M&A transactions and the R&D and license agreements put in place with AbbVie just two or three weeks ago. Broadly speaking, the net impact of those transactions is neutral. We have an R&D milestone income around EUR 30 million. We have R&D costs associated with the Mithra acquisition. And we have. It's not a transaction, but it's still a one-off item affecting EBIT directly.
It has to do with the lower Vraylar guidance, so to speak, the lower Vraylar expectation for this year. I'm very proud of the three major steps we took in three of our business units that are extremely important, not only from the point of view of this third quarter, but have implications well beyond 2024. They're all foundational for our future growth and success. A lot of stuff happened on top of those three, which I usually don't show you in this earnings conference call. But this time, I asked Róbert Réthy that we make an exception because there's just so many things going on. And I'm very proud of the intensity and energy level that we have now in this company. Not only did we sign a new discovery framework with AbbVie three weeks ago, which resulted in the $25 million royalty - well, $25 million milestone income.
But we also reported that 932, our lead compound, which is also known as Vraylar 2.0, has entered Phase 2 officially after the first subject was dosed in October. That's a very encouraging development from the point of view of our future portfolio in the 2030s. Also, on top of the acquisition implemented in January, we licensed ustekinumab biosimilar for the EU, UK, and Switzerland in an effort to expand the biosimilar portfolio further. We also inaugurated our new cutting-edge biopharmaceutical facility in Budapest, the largest capacity expansion project in my seven years since I took this job. Additionally, the first positive cash flow coming from the Mithra acquisition was received upon the approval of Fuji Pharma's Alyssa. This is the Drovelis combination brand name for Japan. We have a very strong and fruitful partnership with Fuji Pharma, who is now emerging as a leading player in women's health in Japan.
So lots happened, as you see. And I thought I'd show you this slide because I think it's exceptional. We also are proud to be now reporting all of this to you from our new headquarters building. It's located in the same place, in the same district of Budapest, in the same street as you found us before. It was opened in July 2024, right next door to the manufacturing and R&D building, reflecting the continuity with our 120-year history. At the same time, the building demonstrates our core values and the innovation and global ambition that we have had in recent years. Also, there's a lot of open space, a lot of community areas here. I cordially invite all of you to come and see. It's a space which sets the standards very high.
It sends the message to all of us, including myself or myself first and foremost, to put in a high-level effort as reflected in the quality of this building. So we're proud to be working in an environment like this, and it sets the standards very high for us. Also, from an environment point of view, environment protection, sustainability point of view, the building is very well equipped, as reflected also in several professional awards and certificates that we have received in terms of energy efficiency and so on. The second thing I wanted to share with you here is our renewed focus on diversity. Renewed meaning... or redoubled is what I was trying to say. Renewed wouldn't be quite right because it's a new thing here.
Diversity is key not only because of all the social aspects of ESG, but also because, in our view, a strong organization is a diverse organization for a number of reasons. One, a diverse organization is able to integrate knowledge from the external world. If the team is too one-dimensional, if the team is uniform, consists of similar people, similar backgrounds, similar age, similar sex, similar training, similar nationality, or same nationality, then the ability to integrate knowledge will be impaired. Secondly, diversity is important for us in order to make sure that we have a high energy level in the company in the sense that we don't settle in a low point, in a local minimum, and look around and see obstacles and limitations everywhere. We need a high degree of freedom organization which sees opportunity and which has an ability to grow.
Third, our international ambitions in the past 15 or so years require that the team become international to the extent possible. And even though half of our employees have worked outside of Hungary for many years, we felt that it's important that the headquarters itself becomes more internationally minded. And in my view, the step in between becoming international in our mindset is becoming diverse first because there's no way to become internationally minded if you're not sufficiently diverse. This is what we've learned over the years. This and not any political or ideological motivation is what put diversity and equity, inclusion, DEI into our focus. And this is what we'll be working with in the coming years. On to the financial figures now. Some detail for you on top line on this slide.
You see a 12% growth, FX- adjusted, which is 14.5%, the number you've already seen, bringing our revenues in the first nine months to EUR 1.6 billion from pharma. The picture has improved compared to June 30th in the sense that the growth is even more broad-based than it was at the time. You see Eastern Europe catching up and now providing a positive contribution. You see General Medicines also contributing more strongly. You'll see this on the next page also. And the FX impact is quite remarkable.
It went from minus close to 6 billion HUF as a consequence of a weak ruble in the first quarter to a positive contribution in the first nine months, given that the ruble's impact, which is - HUF 2 billion , is more than offset by the positive impact from the euro, the U.S. dollar, and also other currencies, including the PLN and other regional currencies. If we move on to business units, it's quite clear that this is a broad-based growth pattern that we've seen over the first nine months, with General Medicines giving me the most joy as it moved into the double-digit territory at 10.6%. FX- adjusted, it's a bit less, 9.2%, but it's still a nice catch-up story intra-year.
Remember, it started a bit softer in the first quarter, but that effect is now evened out in the first nine months, at least we expect the same trend to continue into the end of the year. Women's Health is a bit softer in the third quarter. This was expected. Remember, we spoke about the second quarter shipment and timing effects that brought the first two quarters a bit higher than what we had expected for the full-year run rate. Third quarter is a bit weaker as a consequence of that. Overall, we're exactly where we want to be in Women's Health revenues. And then biotechnology and CNS, you see numbers above 20 here. Biotechnology was helped by the transaction in January, which is now above the line since June onwards, and also strong demand for CDMO services.
In CNS, Vraylar, those numbers are quite a bit smaller and less significant as a contribution, but it's nice to see Reagila doing really well also outside the U.S. When it comes to costs, I'd like to just highlight two things. First, we're not happy with 13% OpEx. At first sight, this is a big number. Even though our ratios have improved, there are one-off factors explaining the 13% growth, and both of those one-off factors have to do with our M&A transactions. First of all, R&D spending went up as a consequence of the Mithra asset requiring funding. We knew this. It was calculated in the transaction value. Nothing surprising about it. It still is on top of the figures that we had at the time of the guidance, and secondly, the same is true for G&A.
G&A costs were up as a consequence of the sequence of deals that we put in place in the first half. So 13% growth overall is the consequence of those two developments. Cost of goods and sales and marketing costs were really well-behaved, which brings us to clean EBIT, which went up by 16% FX- adjusted, 18% headline. And the composition, I think, is quite encouraging. Now is the time that I think also the organization is really feeling that the work we've put in over the years is becoming visible in the financial figures. The underlying business is showing signs of real strength also in the financial report. And that's a great recognition. It's a great endorsement for us that the work we've done across every single function in this company, across the portfolio in the pipeline, in cross-functional, how to say this, in cross-functional collaboration and processes.
All of that is now being rewarded. This is the way we feel about this year's figures so far. Also, notice that the biotechnology drag went from five to 2.5. I can't remember the last time this number was below five. So again, a very encouraging figure. Not sure this will be the run rate from here, but certainly we are now moving, converging toward a break-even in 2027, and then the aim is for the biotechnology business unit to start generating profits for the group beyond 2027. General Medicines, and Women's Health were strong, as not much I'd like to share on those unless there's questions which we can discuss after. Below the line, there's a lot happening. I would like to ask István Hamecz to comment on the below-the-line figures.
Good morning, everybody. As the numbers say it all, we had a very strong bottom line.
It's due to the very strong operational performance and not much distorting effect, except taxes and impairment and provisions. When we looked at analyst expectation, we have seen that they expected overall higher net profit. The only divergence we had here compared to what was expected is financial FX gains and losses. It's very hard to calculate, but the bottom line is that due to temporary U.S. dollar and Russian ruble setups at the end of September, compared to the first half of the year, we had basically HUF 20 billion Hungarian forint unrealized FX gains just disappeared. That's why FX gains and losses are almost negligible this time. Given that even last year we had very large FX losses, our net profit came at HUF 175.3 billion Hungarian forint, which is a very strong 43% growth compared to next year.
As far as the impairment and the provisions concerns, we are working on that issue. The provisions are we made because we had already seen some triggering items, which we will formally record in Q4 in the normal annual cycle, but we didn't want those items to be a surprise to anybody. As far as the free cash flow concerns, here you can see the same picture. Basically, we had a very strong free cash flow generation, which was slightly distorted by the increase in net working capital. I mean, annual increase, but that's also improved compared to the previous quarter. We still had a mild CapEx spending, so that's why this 164.1 billion HUF is a very strong free cash flow. In this particular quarter, there were no major intangible or M&A transactions. We paid the dividend also in the second quarter.
This quarter's contribution to the cash flow usage was not very strong. And that's why, due to the strong cash flow improvements, we accumulated around 40 billion HUF in cash. As you can see, we have recorded a small improvement in the cash conversion cycle compared to the previous quarter. And now, even if we compared on a like-for-like basis to last year, the increase is almost negligible. But we are still working on the cash conversion cycle.
Thank you. Finally, just a few words on the pipeline. A lot of the most important items have been discussed separately. For example, RGH-932 entering Phase 2. And also the appearance of Women's Health projects here and there. The important thing to note is, I think, General Medicines' activity in terms of bringing products to the market.
There's a wave of patent expiries of which we can exploit quite a few, especially in the field of NOACs and in the field of cardiometabolism. In different geographies, this launch takes place at different times, but there is a series of new product introductions this year, which results in a portfolio renewal for generics at a higher pace than what we were used to in previous years. The number we aimed for was 9%. We might not quite get there, but close. And that's already an achievement. And it's already, for the General Medicines business unit, an important source of dynamism going forward. This was it from me. I'd like to invite you to ask your questions now. Floor is yours.
Thank you very much, Gábor. So basically, we are happy to receive questions now. So please indicate your intention to ask questions.
I think the first one is coming from Alistair, as usual. Please go ahead, Alistair.
Hi, morning, everyone. Thanks for the time and a good set of numbers. I just had a couple of questions. I suppose what I'd like to maybe ask a bit more about is you've got some important biosimilar launches coming up. You've obviously licensed biosimilar Stelara. You've got denosumab coming, etc. So we've seen an improving trend in the margin in the biotech business. But how should we think about that margin during the launch phase, maybe through 2025, 2026? And how do you think that recovers through to profitability, ultimately? And then maybe just a quick question on Vraylar 2.0. Can you maybe give me a reminder of mechanism of action here and why you think 2.0 has a possibility of being better than 1.0? Thanks. Okay.
Thank you, Alistair.
On the first one, biosimilar launch, yes. Thank you for asking that because it gives me an opportunity to mention that the denosumab dossier was filed earlier this year, and we've already discussed the filing itself. But I'd like to mention that the interaction that we've had with the authorities since is very encouraging, which tells me that if we can continue like that, there's a high probability that we can launch on time and have a relatively short approval process, which gives me hope that the denosumab launch taking place next year will be successful and we can start moving toward the $50 million to $80 million peak sales that we had in mind, that we still have in mind. How will the margins be affected? Well, I don't think they'll be affected very much. Our current gross margin is not very far from what we expect to see.
It costs a lot of money to produce drug substance and drug product also. Both are very expensive. So don't expect massive improvements in the ratio. The good news is that sales and marketing costs are significantly lower, even lower than in the case of small molecule generics. So ultimately, the bottom line should benefit from the denosumab launch. In absolute terms, definitely, but also ratios probably in the 20-plus range like today, at least in the profitable part of the business. Vraylar 2.0. Now here, the idea is to cover the part of the schizoaffective spectrum, which is on the side of cognitive impairment and depression. As you know, there are three types of—we've talked about this many times—there are three types of symptoms, three groups of symptoms for neuropsychiatric patients suffering from schizoaffective disorders: psychotic symptoms, cognitive, and negative symptoms.
Schizophrenia tends to come with all three, but it's heavily skewed towards psychotic symptoms. The types of situations and conditions that we aim to cure fall more towards the mood disorder type of symptom groups, which includes negative symptoms primarily, but also cognitive symptoms. Vraylar itself, although it treats psychotic symptoms like any other antipsychotic, has shown benefits on the negative side. We aim to create a compound, or develop a compound, rather, because it's been created already, to develop a compound which helps with negative symptoms and mood disorder, mood stabilization generally, which means a softer, lighter set of conditions than schizophrenia. Our strategy, which we have designed with AbbVie together, is to move away from this stigmatizing label of psychosis and schizophrenia, which is why we're not even developing for schizophrenia. We want to be seen as, although technically an antipsychotic, a mood stabilizer, mood disorder drug.
This is what Vraylar 2.0 is going to be. It has to have a better safety profile too. It's just part of the story because it's less of a heavy hitter. Which phase 1 results tend to support our hope that there's a likelihood Vraylar 2.0 will have a better safety profile and will be even more tolerable than Vraylar.
Thank you.
Thank you very much. Next question comes from Victoria Lambert. Victoria, it's over to you.
Thanks. I've got some clarification questions for the biosimilar business, please. So just for Denosumab, just wanted to check if this has been filed in the U.S. yet by Hikma. And then I don't know if you've given an indication of how big you think the sales from your licensing agreement with Bio-Thera for the Stelara will be. So maybe those two. And then I've got some others after that, please.
Nobody remembers the question anymore. Thank goodness. It was the U.S. filing of denosumab, which has not happened yet. No, you will hear about it when that happens. Also because the milestone will be due. And then on Stelara, well, this is a commercial agreement. We're not manufacturing. We're not developing. It's a commercial license for Europe in the rheumatology therapeutic area, which we're building a portfolio in. We see the quality of this product and the technology as sufficiently robust. And so we expect to earn a margin and use the operating leverage in the European sales organization, which is already focused on rheumatology. There isn't much else I can share with you other than that for the moment.
Great. Thank you.
And then I just wanted to ask about Donesta. If you've started to do the necessary sort of regulatory filings in Europe, maybe just remind us of where you are in that process and when you're hoping to launch in Europe. And I guess there's no update with the U.S. licensing partner. And then my last one is just on the Vraylar 2.0, just the timing around the phase 2 data read. So when we can expect that data read, will that be early next year or middle of next year? Just to get a better idea of when we should be looking out for the data. Thanks.
Yes. Thanks for those questions, Victoria. On Donesta, we highlighted at the time that there's substantial uncertainty around the project in the sense that it's unclear whether we have everything we need to file in Europe.
The first thing we need to do is finish the clinical trials, obtain the data from the clinical trials. This is also why the R&D budget was a bit stretched this year more than expected. Then liaise with the authorities to make sure that we have everything in place. There's a lot of uncertainty around it for the moment, which is also why the transaction value did not really assign much value to the Donesta project. We are pursuing it, of course. No question there. It will take time, at least a couple of months. Early next year is the earliest when we'll have more clarity about when and how and what we're going to submit.
The U.S. partnering will also depend on the success of the European filing and the subsequent engagement with the FDA, whether the European file can be submitted to the U.S. Once that happens, I'm sure partnering will no longer be a problem. But before that, it's still pending. Vraylar 2.0 readout, no, it's nowhere near that date. It's much later. It's about two years from now. And the reason for that is this is not your average phase 2 study. It's more like halfway between a phase 3 and a phase 2. So we'll see data in the second half of 2026, but those data will really tell you what the compound is worth. So I'm asking you to sit tight and bear with us while we generate that data. We expect to file early 2030 for Vraylar 2.0. So that's how the timeline looks right now.
And we have a question from John.
Yes. And it's about emraclidine and the news from yesterday. Right.
That was a big move in the share price, wasn't it? I was surprised to learn also that the M4 compound did not perform as expected in phase 2 for AbbVie. One of two ways you can look at this. One point of view echoed by many across the investor community is this compound was seen by many as a competitor for our pipeline. And the fact that it has not performed is seen positively because our pipeline will get more funding, more attention, more tailwind, generally, more in the focus, more investment, generally. The second point I'd like to make is this story just shows how difficult it is to get it right in CNS. No wonder CNS is the second most R&D intensive therapeutic area after oncology.
It's a very complex field because the brain is a very complex, the most complex entity known in the universe. And so there's a lot of the failure rate is pretty high. The second way to look at it is to question whether AbbVie's neuropsychiatric commitment is real. Well, I don't think that's a fair comment. It is real. And it just shows that a lot of bets have to be made in this field in order to have success. emraclidine was not one of those successful compounds. I'd leave it at that for now. All right.
Thank you very much. Next question comes from Gábor Buchter. Gábor, please go ahead.
Hi. Thank you for your presentation. I just have two first questions regarding the taxation. So it seems that the tax was lower than the global minimum tax requirement for the first nine months.
So is it a fair assumption to model a higher tax rate for Q4 than 15%? And the second one is regarding the FX loss, which was unrealized. So how much of this loss came from the dollar appreciation or other currencies in Q3? And what is your assumption for Q4 if rates stay at current levels? Thank you.
Okay. First, as a tax issue concerns, no, we don't expect higher than 15%, as we explained. Due to these M&A transactions, we enjoyed a temporary tax relief in a sense. So that was a one-off event. As a rule of thumb for fourth quarter and the next year, we expect around 15% global minimum tax, technically slightly lower. But this tax anomaly, what you can see, is purely related to Q2 M&A activity.
As far as the second item concerns, the FX losses, when you calculate the FX losses or gains, you compare to the end of last year. In September, to the end of last year, we have seen basically ruble was around the same. Compared to June, the dollar was much weaker. That was a temporary phenomenon. If you look at the numbers now, ruble is around the same. The Hungarian forint is much weaker against the U.S. dollar. Sorry about that. It's very hard to calculate these FX gains and FX losses. That's the nature of our business, that we have large U.S. dollar and Russian ruble financial items, which revalue each quarter. Perhaps just as a reminder that most of these FX gains and losses, those are the result of, as István said, end-of-the-period, basically mark-to-market or valuation of working capital items.
Most of these, at least in the previous periods, Q1, Q2, Q3, unrealized. So you can see in our financial report, the realized amounts, those are a couple of billion, not more. I mean, I can get back to you exact breakdown, what happened in Q3, but it was both on ruble and on dollar receivables or working capital items when we had actually the reversal of previous gains. So it's not like losses. Previous gains were reversed, disappeared by the end of Q3. If things stay as they are today, then most likely, but we don't want to give any guidance because we also think that this doesn't matter from a bigger scheme of things, that most likely we're going to have, again, some gains, unrealized gains, and at the end of 2024. Exactly. Is that answering your question, Gábor?
Yes. Thank you very much.
Sure.
Then we move to the next one, which should come from David Gorzynski. David, over to you.
Hi. Thank you for taking my question from my side. I want to ask about the impact of Mithra and Helm acquisitions. You were expected to see a EUR 20 million revenue contribution in the second half. I wonder what part of that was recognized in the third quarter already. Maybe if you could give more details exactly in what parts of the business it was recognized. The second question is on the performance of oral contraceptives, which was quite weak this quarter despite weaker forint, quite strong ruble. I wonder if there was something else that was driving this weak performance except for timing of shipments to China and Latin America. Thanks for that.
Let me comment briefly on the Mithra acquisition question.
Generally, we were able to realize about EUR 10 million altogether, maybe a bit more, including the milestone incomes. That was a bigger portion. In Q3, we have just about the same cost level that you would be able to see from the Mithra acquisition, so that is how we proceed. This is totally in line with what we expected at the date of the acquisition. No surprises, around EUR 10 million revenues or income is already realized. Second question, oral contraceptives. We already noted in Q1, Q2 that there were pre-shipment of oral contraceptives to China and other places. It's not a genuine slowdown of the business. It is timing of shipments. Mostly China. There was a big boost to Chinese sales because of registration changes. Therefore, there was a boost to first-half sales of contraceptives which we shipped to China.
And that basically disappeared, this positive impact. It actually turned into a negative one in Q3. That's what you saw in the contraceptive business. And on the acquisitions, just one more comment, that so Mithra was around neutral bottom line and EUR 10 million plus top line, but that was primarily driven by milestones. Q4, no milestones we expect from Mithra assets, but still ongoing R&D expenses, Donesta primarily, but also Drovelis to some extent. So negative impact in Q4, as we commented before. That's the negative clinical impact what we highlighted already a quarter ago and just reiterated this time around. Helm, on the other hand, that's a positive impact on a quarterly basis. That basically the third-party royalty income from teriparatide, what we are now consolidating above the line. Previously, it used to be JVs and associates. On a quarterly basis, it's around EUR 4 million to EUR 5 million.
That was fully reflected in Q3 numbers. That's why that was the bigger reason why the biologics business unit losses narrowed compared to previous run rate. And this will stay with us in the coming quarters.
Thanks so much.
Thank you very much. And I actually don't see any other questions from anyone. So if that's the case, then thank you very much for all of you for being with us today. If you have additional questions, then as usual, just reach out to Investor Relations. Otherwise, we're going to be seeing each other in about three, four months' time with the full year numbers. Thank you very much. Have a great day. Bye-bye. Thank you.
Thank you.