Good afternoon, and welcome to Orion's full year 2025 result webcast and conference call. My name is Tuukka Hirvonen. I am the head of IR here at Orion. In a few moments, our CEO, Liisa Hurme, will present the results for the full year and Q4 last year, after which you will have the possibility to ask questions from Liisa and also from our CFO, René Lindell. We will be first taking call questions through the conference call lines, and after that, we will turn to the webcast. So through the webcast, you have the possibility to type in your questions through the chat function of the webcast. Just before I let Liisa take over, I'd like to draw your attention to this usual disclaimer regarding future forward-looking statements.
With this short note, it's my pleasure to invite Liisa to the podium. Liisa, please.
Thank you, Tuukka, and welcome on my behalf as well. I'll start with the Q4 and with some highlights during the last three months of last year. It's my pleasure to say that all our business divisions had a strong quarter and performed extremely well. Also, we received EUR 180 million sales milestone from Bayer related to Nubeqa. And we were able to proceed with our clinical pipeline by initiating phase II program with ODM-212 molecule in our oncology pipeline. And also our partner, Tenax, in the United States initiated phase III trial called LEVEL-2 with levosimendan for pulmonary hypertension. And Q4 highlights, the base business during Q4 compared to the previous year grew 18.5%, and 60% when we include the previously mentioned milestone.
Operating profit growth was 59%, and including the milestone, 254%, bringing us to 47% operating profit margin in Q4. Operating cash flow per share was slightly lower than previous year, and that's mainly due to the timing of royalty payments from Bayer. The net sales bridge is almost masked by Nubeqa and innovative medicines, as it includes the EUR 180 million milestone. But it doesn't shadow the extremely good performance of other divisions, branded, generics, and animal health. Of course, the divisions are smaller, so the growth in euros is also smaller. This all brought us to EUR 695 million during Q4.
In the operating profit, we of course see EUR 180 million, but a very good development on our royalties, close to EUR 50 million, and also sales volumes brought us EUR 28 million . Price development, COGS, and product mix put us slightly down by EUR 12 million, and the effect of exchange rate on gross margin was EUR 4.1 million. Other operating costs and fixed costs were also well handled, so nothing specific there. So our Q4 operating profit was EUR 328 million. Now I move to 2025. This was an all-time high year for Orion Pharma, both with net sales and operating profit.
I want to take the opportunity here today to thank all my colleagues all around the world in Orion Pharma for this achievement. All in all business divisions, in R&D, in operations, you couldn't achieve anything like this without a very, very good collaboration in the company. So in addition to euros, we also had lots of positive development in R&D. I note approvals, both in Europe and U.S., several new license and collaboration agreements for early-stage technology platforms in our innovative medicines and oncology, but also acquiring and in-licensing product rights for both branded products and generics. Also, MSD, our other significant partner, expanded the opevesostat development to women's cancers, which is wonderful news, both for women suffering from these cancers and taking all the possible opportunities of this molecular mechanism of action.
The board of directors of Orion Pharma is proposing a dividend of EUR 1.80 per share, and this is proposed to be paid in two installments. For the full year numbers, 21% growth in our base business, 22.5, including milestone. Operating profit, 58, if I round it, to 59% growth in base business, and 52% including the milestones. For the full year operating profit margin, this brings us to 33.4% compared to the previous year's 27, and of course, this is mainly due to the, or partly due to the milestone that we received. Operating cash flow was slightly better than in 2024, driven by good sales performance and, and mainly by sales performance, as the milestone will be visible in the cash flow only next year, this year.
Now I move to the divisions. Innovative medicines, here, the net sales is really Nubeqa, either the royalties or royalties and the product sales. And the bar part here describes the sales and royalties, where the growth was close to 38%. Of course, there, the milestone also included, brings us to 152% growth. And then for between the full years, the growth was 60% for the base business and 55%, with the milestone. And then there is the picture that we will always want to have here to remind you of the very back-end loaded character of this business, due to the tiered royalties from Bayer. And we can see it extremely well here at in the Q4 2025, where the royalties jump up significantly from the previous quarter.
The product deliveries and product sales between the Q3 and Q4 last year remained at the similar level. Branded products continued in Q4 the two-digit number growth with 11%, and the full year growth was close to 10%. For the respiratory portfolio, the growth comes from the budesonide formoterol combination product. For the CNS, it comes from Stalevo or the entacapone product family for Parkinson's disease, and especially retaining the rights in Japan back to Orion Pharma, but also from some new products that we've been launching in Europe. And then a significant growth of our women's health portfolio. Generics and consumer health really did it last year. 5.7% growth during the Q4 is above all averages in this business, and 4.6% for the full year as well. And this is a result of a lot of activities.
We've done more than ever of launches in our current territories. We've had some bigger launches also this year for the products that have where the patents have ended, and this comes also from all of our regions. Animal health quarter four was more how would I say, calm compared to the previous quarters, with only 1% growth, and this is mainly when you see these type of changes on a quarterly basis in animal health, it's usually the delivery timing of products to our partners. And then again, it didn't have a big effect on the yearly full year sales, where the growth is close to 10%.
In a similar way to generics, the growth really comes from a broad, even a broad geographic region globally, but also from a broad portfolio, both on the livestock and companion animal business. This is a nice list of our 10 biggest products. Almost all the products are growing, some even with very healthy two-digit numbers. Then some are more or less at par, like Animal Health, Dexdomitor, and Burana. Maybe it's good to note here that the Divina series, the women's health portfolio, has now climbed to be the number four, so it has actually now climbed up and passed the Animal Health sedative portfolio.
This is only a very natural order of products here to have the innovative products, Nubeqa, as a first fastest-growing product, and then all the three main products from branded side as the next ones. And then we have biggest generic products represented here. Simdax, unfortunately, of course, declining. Fareston's decline again is a matter of delivery timings. I think the big message in this slide is that, to my recollection, this is the first year when Innovative Medicines is our biggest division. So this is clearly a kind of a landmark event for Orion. Generics still hold almost 30% or generate 30% of our net sales, and branded products 17%, and the two other divisions, Animal Health and Fermion, are significantly smaller ones. No significant news on our key clinical development pipeline.
I already mentioned that we've started phase two for the ODM-212 in two different indications, mesothelioma and EHE. Both are rare oncology indications. We were able to start this study already in the end of the last year and are aiming to start a study with the combination of this molecule to some current oncology treatments during the first part of this year. And also you can see here now two studies for levosimendan, also the LEVEL -2. And this is a very nice slide on sustainability, this time about diversity. Orion has been ranked as number 3 in the Nordic Business Diversity Index, which means that if you look at the numbers here on this slide, how men and women are what is the share of men and women on different level of the organization?
You can look at the board of directors, where almost 40% of members are women. In executive team, almost 45% of the members are women. And if you look at the whole personnel in Orion Pharma, almost 56% of the personnel are women. And there are a lot of other information here of which we are very, very proud. One that I can mention is the accomplishment of the code of conduct agreements with our suppliers, which is 98%. We provided our outlook for 2026, for this year, already on January fourteenth, and it holds.
So we've stated that our net sales range for this year is EUR 1.9 billion from EUR 900 million, EUR 1.9 billion- EUR 2.1 billion, and our operating profit range is EUR 550 million, from EUR 550 million- EUR 750 million. Here are our upcoming events, and our general meeting, annual general meeting will be held on 24th of March. I thank you for your attention at this point, and we are ready for your questions.
Thank you, Liisa. So now we are opening the floor for Q&A. Just as a reminder to the webcast viewers, that you can type in your question using the chat function of the webcast. But first, let's turn over to the conference call lines, and I'd like to hand over to the operator at this point.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Sean Hammer from Jefferies. Please go ahead.
Hey, thank you so much for taking my questions. Just two from me, please. We can take them one at a time. So firstly, could you just outline how you expect OpEx to develop over the course of this year, as in compared to 2025? What sort of levels of SG&A and R&D are we, are we looking at as a sort of percentage of the top line? It's my first question.
I'll give this question to—
Yeah.
René.
So of course, we are not giving a detailed guidance on within the guidance on OpEx levels, but we have been stating that we are initiating more activities in the clinical pipeline. We have ODM-212 that entered phase two and are planning to expand. So R&D OpEx, you can imagine that we are planning to increase during the year. And then when it comes to sales and marketing, we have also been investing more in those efforts in across our countries, especially in the Branded Products division. So also there is some growth during 2026.
Got it. Thank you so much. Just for my second question, please. Are you able to provide us with some further guidance as to your agreement with Bayer and what that looks like following the Nubeqa's patent expiries? I think you previously stated low-level percentage royalties after the patent expiries, but what is the low level, and will that eventually go to zero after 2035?
I think exactly as you pointed out, it's a low-level single numbers of royalty that we can receive from Bayer after the product has become generic. And maybe did you have something else in your mind regarding that? We can confirm that here, but.
Yeah, and then will it go to zero after 2035? I think that's when the last patent expires in Europe, if I'm not mistaken.
To my recollection, in a very general way, as these agreements are done, it's a region-by-region agreement, that whenever patents expire or generic competition starts in a certain region, then the new royalty rate kicks in.
Got it. Thank you so much for taking my questions.
The next question comes from Sami Sarkamies, from Danske Bank Markets. Please go ahead.
Okay, hi. I have a couple of questions. We'll also be taking this one by one. Starting from the outcome for last year, it was a great year, but you didn't actually surprise against your own expectations around mid-2025, even though Nubeqa sales actually developed very strongly during the second half of the year. So why did we land at the guidance midpoint and not above it? My point is that Nubeqa probably reached some sort of blue sky scenario during last year, but in which areas that wasn't the case. So was it related to other products not selling that well, or maybe costs becoming larger than anticipated?
Yeah, so if you look at the net sales, we landed pretty close to our upper range of our outlook. So that clearly was, you know, on the high side, not in the midpoint. Then on the operating profit, we were, you know, quite there, close to the midpoint. However, there as well, we had a little bit more of OpEx, but again, that we kind of expected. I said we had R&D investments last year that increased significantly year on year, and especially even if you consider comparable without the write-downs in 2024, you can see that actually the ongoing activities increased even more. So in a way, you could say we really executed on the plan, both in the R&D side and also on the sales and marketing side, we went exactly as planned.
So I think for us, you know, we were quite at the mark.
Okay. And then, going back to the cost outlook, that was also discussed, so that the R&D cost increase will be quite a bit more material this year than sales and marketing cost increase?
Not necessarily. So I think, you know, in both sides we are investing, so we'll have to see, of course, how the year goes. Sales and marketing, I think it's pretty clear what we have, you know, in the budget, that it will increase R&D as well, increasing. But, you know, again, as you know, it's less predictable, so that's why also there is a variety in the outlook range that includes a big part or also plays a role of the R&D expense.
Mm-hmm. And maybe to continue from that, that we are really, as you said, as René already said, executing our plan. We were executing our plan for 2025, and we are executing our strategy, which is to invest more in R&D, and you can already see it in 2025, if you compare 2025 numbers to the 2024, and that is expected to continue.
Okay, and can you still open up a bit the factors that are driving sales and marketing cost increase this year? And maybe also you're planning to have a presence in the U.S. market someday. When do you think those more material sales and marketing investments will happen?
I think the largest factors would be, you know, in branded products and obviously Easyhaler as being the biggest product. That's where we have the most activities. So logically, driving more sales there, you know, requires also activities in that regard. The U.S.A. establishing that, you know, platform, of course, that's also plays a role, but still quite small in the big picture of things. But of course, we are steady-
Mm-hmm
- step by step, also-
Mm-hmm
- taking activities there. But it's a very small scale. But, you know, it's all part of the total.
Maybe, maybe to add on-
Okay, and then my-
Of course, also the Endo royalties, which we are paying. As Nubeqa grows, of course, we are paying more and more royalties to Endo, and that is shown in the sales and marketing cost.
Thank you for
Yes
-T uukka, to remind about that. So that really grows as the Nubeqa sales grow.
So that drives as a variable-
Yes
- basically expense with Nubeqa's growth.
Yes, and then my final question would be on capital investments. You had quite, quite an increase last year. You're guiding for similar level this year. Where are you investing at the moment?
If I single out the largest investments, those would be in Nubeqa production... especially in the API production. And then secondly, last year we also had an Easyhaler, but of course, we are continuing our course-
Mm-hmm.
Across all our divisions. So as we are growing, we need more capacity for the products that we are producing on our own. So, you know, in a way, it grows also in line with the business.
Nice.
Naturally, one of the big thing is really darolutamide.
Okay, thank you. I don't have any further questions.
The next question comes from Iiris Theman from DNB Carnegie. Please go ahead.
Hi, thanks for your presentation. I have three questions, please. So firstly, R&D costs were higher than I expected in Q4. Did those include any one-offs, for instance, related to ODM-105? That's my first question.
Well, mainly the R&D costs, I don't recall that. Maybe René, you know, the details, but I don't recall if they had any one-offs for 105. But of course, the R&D cost increase is really according to strategy, according to our plans. And as we have several biologics already chosen candidates that we will hopefully bring to clinical development, at least one this year and the next in 2027, the balance or the how the R&D costs are actually sequenced when you develop biologics. There are a lot more costs already before the clinical development, when you need to have your final product, your final pharmaceutical product and commercial batches validated before you enter your clinical studies.
So I do fully understand it might be difficult to understand how where do we spend the money, when you still see that there are not that many projects in the clinical phase. So those are actually quite expensive in the light of earlier pipeline molecules that we've had. And of course, we've been bringing ODM-212 into clinical phase and studied the phase II study last year, and that, of course, has also includes kind of one-offs and payments for CROs. So I don't... Nothing to do with 105, unless René says otherwise.
Yeah, maybe just on the dynamics of the R&D spend. Typically end of the year, there is a bit more bills for-
Mm, mm, mm
- external, external CROs. They tend to, you know, be back-end loaded over the years. ODM-105, yes, there were a few. I would say single-digit millions in terms of-
Mm
- payments that were or that we booked basically for things that are still being done to ramp down.
Mm.
And then, yeah, as you said, then also starting up the new-
Yeah
- new, clinical trials, there's also upfront payments-
Mm-hmm
-- that came there. But, you know, all of these, you know, this is gonna be probably the typical one, that you have some fluctuations.
Mm.
The big message is, in a way, that, you know, from-
Mm
- if you look the full year to full year, then we expect, you know, a steady growth of R&D.
Mm-hmm.
Okay. And, still, related to R&D costs, so is it fair to assume that your costs this year will be in your historical range of about 10%-12% of sales?
I would not promise that the history is the best predictor of the future.
Mm.
It will really depend on how the projects move forward.
Mm.
So we've been many years in the 11%, but as I said, the target is to move forward a more, you know, further in the clinics, and that might mean also that we exceed the clinical or the historical ranges, but we'll have to see how the year goes.
Okay. And then, secondly, what was the reason behind the flat Nubeqa product sales quarter-over-quarter in Q4?
Well, there is a lot of fluctuation, you know. Generally, of course, the deliveries have been growing as the sales been growing, but there, as we've stated many times, so there are differences between quarters. It's a bit of a same thing as with other products to our partners, that it's really a might be a timing of delivery between one day to another, and then it ends up to a different quarter or even to a different year.
Yeah.
Okay. And then, my final question is related to R&D pipeline. So what is your expected pipeline news in the next 6-12 months?
Well, I think the next one will be the start of the ODM-212 in combination with some current oncology drug, drugs that are used. As I said, we hope to start that, those studies before the summer, during the first half of this year. And from there on, during this year, we aim to bring one biologic product in clinical stage. And then going forward to 2027, there should be results, and now I'm looking at Tuukka, already from one of the Nubeqa studies. So are they both readouts on 2028?
The ARASTEP study for the BCR is due to read out in 2027-
Exactly
- then the DASL-HiCaP is due to read out in 2028. Still during this year, so in the second half of 2026, our partner, Tenax, is expecting to read out the first LEVEL phase III trial in the second half of this year?
Exactly. So this year's events is really starting the combination study with ODM-212, the ODM-212 study results and also starting the biologics clinical development.
Do you expect anything related to opevesostat start in the next 12 months?
I think that's something that you would need to ask from MSD.
Okay. Thank you.
The next question comes from Alex Moore from Bank of America. Please go ahead.
Hi, it's Alex Moore on for Charlie Hayward, Bank of America. Two from you on Nubeqa. On the greater than EUR 1 billion guidance on net sales, can you confirm your assumptions around expansion into early line settings on the date of June 2027-2028? And then secondly, just a clarifying question on the royalty post post LOE. You mentioned that the royalty rate drops to a very low rate after generic competition has started on a country-by-country basis. Can you give a bit more color on timing, i.e., does this mean the royalty rate drops on the launch of the first generic competitor in a particular market, or is there more nuance there?
Well, I think. May I repeat your first question? So, did you ask whether the early stage indications with Nubeqa are included in the EUR 1 billion?
Correct.
That was your question. Yes, they are. In a similar way as anything that Bayer is saying about Nubeqa, they include all the indications or the older studies that are ongoing, that they should be successful to reach what they are planning. And then your next question was regarding the royalty rate after the loss of exclusivity and how that would go. Usually, the agreements are designed so that the royalty rate drops either when the first generic enters the market or the patent is expired. Region by region.
Cool. Thank you very much.
All right, thank you. We have now, for the time being, exhausted all the questions from the conference call line, then we can turn into the webcast questions. We have a few of them here. Let's start with a few one, from Matti Kaurala from OP Markets. So the first one from Matti is, what kind of reasons impacted on increased R&D, and especially the sales and marketing costs in Q4?
I think we already discussed the R&D-
Mm-hmm
- costs, so I think already answered that. Will not repeat it. So sales and marketing, again, maybe repeating what also Tuukka mentioned, that Endo royalties was a big part of that.
Mm.
Of course, the EUR 180 million milestone was one big event in Q4-
Mm
- which also include end of royalties. But then the other piece is just, you know, added activities-
Mm
- that we have. We have added more salespersons across our markets, where we are see good momentum and growth, for example, for Easyhaler.
Then we'll continue with the cost side, a hot topic today. This is again from Matti. What should we think about, especially sales and marketing costs in 2026? Are they going to have similar seasonality as in 2025, or is Q4 level as the new normal, so to say?
Mm. I think there is some fluctuation between the quarters due to various, various factors, so I think it also kind of might be a bit of risky to take 1 quarter and multiply by 4, but rather look at the year-total year levels, as we typically do. You get a more continuous picture of how that would develop. Yes, there is always some seasonality always there. Typically also Q4, even in that space, can have some, some extra costs that, that are backloaded, as like in R&D. So I would also there, you know, look at a bit more bigger picture of how the costs develop.
Thanks, René. Then the final one from Matti, is related to Fermion. Typically, Fermion sales has been decreasing due to increased Nubeqa production, so why did the external sales of Fermion increase during Q4?
Well, this is a good and nice question, because this—let's remember that these sales, as was pointed out, are the external sales for other pharma companies, and we were clearly able to deliver before the year end more than we've been able to do earlier. So I think this is, this is a result of good deliveries before the year end.
Thanks, Liisa. Then move on. This question comes from Viktor Sundberg from Nordea Markets. "So just wondered if you could provide any details on what you assume in the high end and in the low end of your guidance ranges to get a better feel for the risks and uncertainties going into 2026?
Mm. Yes, of course, I can't give you, you know, details within the range, but I think if we talk about broadly about the range, the biggest factors, of course, for this year is Nubeqa. That is growing at the rate as we're seeing. We expect it to do very strongly this year. It grows as its share of the total business. Naturally, that means also the range where Nubeqa lands and the impact on Orion is increasing. We mentioned already R&D, OpEx; it is also increasing, but there is uncertainty over there as well, that how projects move forward, how fast and how the spend is.
Plus then other factors, the U.S. dollar to euro FX starts to impact more, because a lot of the Nubeqa sales, of course, is in the U.S.A., so that is in there as well. Plus, the other divisions bring their kind of normal, normal variations as well. So it's kind of sum of all of these, and in the end, as we've been typically stated, you know, when we look at the midpoint, that's kind of our, you know, base case where things move according to our plans.
Thank you, René. Now, we have exhausted also the questions from the webcast, and I can hear that there are no follow-ups on the conference call line. So at this point, I'll hand over to Liisa for any closing remarks.
Thank you for your attention, and again, thank you for everybody for this excellent year, 2025. We are heading towards another good year of 2026. Thank you.