Orion Corp New B Shs

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 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. And 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 180 million sales milestone from Bayer related to Nubeka. And we were able to proceed with our clinical pipeline by initiating phase two program with ODM212 molecule in our oncology pipeline. And also our partner Tenax in the United States initiated phase three trial called level two 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. And 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 Nubeka and innovative medicines as it includes the 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. And this all brought us to 695 million euros during Q4. In the operating profit, we of course see the 180 million. but a very good development on our royalties, close to 50 million, and also sales volumes brought us 28 million euros. Price development, COGS and product mix put us slightly down by 12 million, and the effect of exchange rate on gross margin was 4.1 million. And other operating costs and fixed costs were also well handled. So nothing specific there. And so our Q4 operating profit was 328 million. And now I move to 2025. This was an all time high year for Orion Pharma, both with net sales and operating profit. And I want to take the opportunity here today to thank all my colleagues all around the world in Orion Pharma for this achievement. 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. And I note approvals both in Europe and US. Several new license and collaboration agreements. license agreements for early stage technology platforms in our innovative medicines and oncology, but also acquiring and licensing product rights for both branded products and generics. Also MSD, our other significant partner, expanded the Ope Vesastat development to women's cancers. which is wonderful news, both for women suffering of these cancers and taking all the possible opportunities of this molecular mechanism of action. And Board of Directors of Orion Pharma is proposing a dividend of 1.80 euros 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 percent growth in base business and 52 percent, including the milestones. And for the full year operating profit margin, this brings us to 33.4 percent 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. And operating cash flow was slightly better than in 24. driven by good sales performance and mainly by sales performance, as the milestone will be visible in the cash flow only this year. And now I move to the divisions. Innovative medicines, here the net sales is really Nubeka, either the royalties or royalties and the product sales. And the dark 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 there. And we can see it extremely well here in the Q4-25, 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 formaterol combination product. For the CNS, it comes from Stalivo 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 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 this 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%. And in a similar way to generics, the growth really comes from a broad here, even a broad region, a 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. And this is only a very natural order of products here to have the innovative products Nubeca as the 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. Simdocs unfortunately of course declining. Farreston'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. Generic 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 ODM212 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 Levocimendan also to level two. And this is a very nice slide on sustainability, this time about diversity. Orion has been ranked as number three in the Nordic Business Diversity Index. Which means that if you look at the numbers here on this slide, how men and women, 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, they are 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 14th and it holds. So we've stated that our net sales range for this year is 1.9 billion from 1.9 billion to 2.1 billion. And our operating profit range is 550 million from 550 million to 750 million. And 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. 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 on 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 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Sean Hammer from Jefferies. Please go ahead.

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 OPEC 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 looking at as a sort of percentage of the top line?

I'll give this question.

So, of course, we are not giving a detailed guidance on within the guidance and OPEX levels, but we have been stating that we are initiating more activities in the clinical pipeline. We have ODN 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 across our countries, especially in the brand and products division. So also there is some growth during 26.

Right. Thank you so much. And 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 Becker's patent expiry? I think you previously stated low-level percentage royalties after the patent expiry. 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. 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 Sakamis 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-25, even though Nubeca 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 Nubeca 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 as 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 24 you can see that actually the 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 in 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 is it 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. As a 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.

And maybe to continue from that, that we are really, as you say, as René already said, executing our plan. We were executing our plan for 25 and we are executing our strategy, which is to invest more in R&D. And you can already see it in 25 if you compare 25 numbers to the 24. And that is expected to continue.

Okay, and can you still open up a bit the factors that are driving sales and marketing costs increase this year? And maybe also you're planning to have a presence in the US market someday. When do you think those more material sales and marketing investments will happen?

I think the largest factors would be in branded products and obviously Easyhale as being the biggest product. That's where we have the most activities. So logically driving more sales there requires also activities in that regard. The USA establishing that 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 step by step also taking activities there, but it's a very small scale. But, you know, it's all part of the total.

And maybe to add, of course, also the Endo royalties, which we are paying. As Nubeca 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 Tuukka to remind about that. So that really grows as the Nubeca... So that drives as a variable basically expense with Nubeca's growth.

Yes. And then my final question would be on capital investments. You had 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 Nubeca production, especially in the API production. And then secondly, last year we also had in Easyhaler. But of course, we are continuing our course 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. But naturally, one of the big thing is really darolutamide.

Okay, thank you. I don't have any further questions.

The next question comes from Iris Tiemann 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 installs related to ODM 105? This is 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 27. The balance or how the R&D course 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 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 ODM212 into clinical phase and started the phase two 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 Rene 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 external CROs they tend to you know be back and loaded over the years audio 105 yes there were a few I would say single digit millions in terms of payments that we booked basically for things that are still being done to wrap down. And then, yeah, as you said, then also starting up the new clinical trials, there's also upfront payments that came there. But, you know, all of these, you know, this is going to be probably the typical one that you have some fluctuations, but the big message is in a way that, you know, from if you look the full year to full year, then we expect, you know, a steady growth. growth of R&D.

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 to 12% of sales?

I would not promise that the history is the best predictor of the future. It will really depend on how the projects move forward. So we've been many years in the 11%, but as I said, the target is to move forward 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 new pickup product, say, squadron over quadron in Q4?

Well, there is a lot of fluctuation. Generally, of course, the deliveries have been growing as the sales have been growing, but as we've stated many times, there are differences between quarters. It's a bit of the same thing as with other products to our partners, that it really 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.

Okay. And then my final question is related to R&D pipeline. So what is your expected pipeline news in the next six to 12 months?

Well, I think the next one will be the start of the ODM212 in combination with some current oncology drugs that are used. As I said, we hope to start 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 27, there should be results. And now I'm looking at Tuukka already from one of the NU-BECCA studies. So are they both readouts are in 28?

The ARA step study for the BCR is due to readout in 27, then the Dassault HiCap is due to readout in 28 and still during this year, so in the second half of 26, our partner Tenax is expecting to read out the first level phase three trial in the second half of this year.

Exactly. So this year's EVENS is really starting the combination study with the 212 level study results and also starting the biologics clinical development.

And do you expect anything related to OPEVESO 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 more from Leon Nubeka. On the greater than one billion guidance on net sales, can you confirm your assumptions around expansion into early line settings on the data due in 27-28? And then secondly, just a clarifying question on the royalty 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. Could 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 Nubeca are included in the 1 billion? Correct. That was your question. Yes, they are. In a similar way as anything that Bayer is saying about Nubeka, they include all the indications or all the 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. 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 the 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 cost, so I think we already answered that. I will not repeat it. So sense of marketing again, maybe repeating what also Tuukka mentioned that end royalties was a big part of that. And of course, the 180 million euro milestone was one big event in Q4, which also include end royalties. The other piece is just added activities that we have. We have added more sales persons across our markets where we see good momentum and growth, for example, for Easyhaler.

Then we'll continue with the cost side, hot topic today. So this is again from Matti. What should we think about especially sales and marketing costs in 26? Are they going to have similar seasonality as in 25 or is Q4 level as the new normal, so to say?

I think there is some fluctuation between the quarters due to various factors. So I think it also kind of might be a bit risky to take one quarter and multiply by four, but rather look at the 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 extra costs that are backloaded like in R&D. So I would also 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 new backup production. So why did the external sales of Fermion increase during Q4?

This is a good and nice question, because 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 a result of good deliveries before the year end.

Thanks, Liisa. Then move on. This question comes from Victor Sundberg from Nordia 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 26.

Yes, of course, I can't give you details within the range, but I think if we talk about broadly about the range, the biggest factors, of course, for this year is Nubeca. It 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 Nubeca 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 US dollar to euro FX starts to impact more because a lot of the Nubeca sales of course is in the USA so that is in there as well plus the other divisions bring their kind of normal variations as well so it's kind of some of all of these And in the end, as we've been typically stated, when we look at the midpoint, that's kind of our 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.