Thank you for the introduction, Antti, and thank you Inderes for having Orion here today. Good afternoon. My name is Tuukka Hirvonen. I'm the Head of IR here at Orion. And welcome to hear more about how we at Orion are building shareholder value.

But let's start with a brief introduction to the company. Should there be someone online who is not so familiar with us? So Orion is a more than 100-year-old pharma company that has a strong focus and decades of experience and a proven track record in innovation and development of new pharmaceutical treatments. Today, at Orion, we are more than 4,000 in over 35 countries across the world. Financially, we are very solid, and the fact that as a company, we are having a positive impact on people's lives is a great source of motivation and inspiration for all. At Orion.

Orion is a fairly diversified pharma company. We have five different business divisions, out of which Innovative Medicines is responsible for the development and commercialization of new treatments. At the moment, the only commercial product in this division is Nubeqa, which our partner Bayer is selling globally. But obviously we have more opportunities in our R&D pipeline, to which I will come back later on during my presentation. In branded products, we have three therapy areas, which all have one key product on and around which they are building growth. The growth comes from in-licensing new products or developing new products there, either internally or even acquiring assets there.

In the respiratory therapy area. The key product portfolio is the Easyhaler platform. Easyhaler is a dry powder inhaler that Orion has invented, and we have introduced six different generic molecules to the device. In the CNS area. The key product is our good old entacapone for the treatment of Parkinson's disease. And finally, in women's health. The core platform is the Divina series, which is a hormone replacement therapy for women suffering from menopausal symptoms. Geographically, this business is mostly focused in Europe and certain Asia-Pacific countries.

Then again, our generics and OTC business is more regional, focusing on Finland, Scandinavia and Eastern Europe. We have a wide portfolio of products with more than 300 different products in the portfolio. Then we have innovative and generic animal health products, which we are selling directly and also through partners globally. Fermion's most important role is to manufacture the active pharmaceutical ingredients to Orion's current innovative and most important legacy products. Here we are reporting the external sales. So not the internal sales which we are using for our own purposes. And as you can see from the slide, all of the divisions recorded good growth for the first nine months of this year. Of course, with the exception of Fermion, where the external sales were declining due to capacity constraints, the divisions, they are very different. But then again, they form a balanced and good entity of which we are very proud.

On this slide we can see our financial development from the past six years. I'd like to highlight two things here. First of all, in the previous decade. So in the 2010s, Orion faced several losses of exclusivity in our innovative, at that time, Innovative Medicines. And that slowed us down. But thanks to our other diversified and stable businesses, we remained on a growth path. However, it is fair to say that the growth was very modest during that difficult time.

And now, as we can see this decade, with the help of Nubeqa and also with the help of the fact that these headwinds coming from the losses of exclusivity are now behind us. We are seeing very healthy growth and also good growth projections for the several years to come. The second thing I want to raise up here are the milestones. They are an integral part of our business model, but on the other side they cause some fluctuations to our figures, especially to the operating profit. But we don't complain, and I don't think that our shareholders do that either. And just as a reminder, on this slide we are not seeing it. But last week we reported that we will again book one milestone, the size of which is €180 million, related to the sales achievements. So this will be booked in Q4 this year, and it will be the last milestone related to our package with Bayer. So from now on, the only income we are getting from Nubeqa will be the royalties, which are also currently growing nicely.

Well, how about then growth going forward? We can approach this question through our financial objectives, which we have set for the strategy period 24 to 28. First of all, we aim to grow the top line by more than 8% CAGR and to grow the operating profit faster than the top line, meaning that we will also be improving our profitability. We want to maintain a strong balance sheet and make wise investments, and that's why we are having the equity ratio and return on equity. Also as a target in our financial objectives. And finally, last but not least, we aim to pay an annually increasing dividend with a sustainable payout ratio. These objectives give us a certain framework within which we can then determine how much we can, for instance, utilize money in the R&D section of the company.

Well, why invest in Orion then? We can split this question into key themes, out of which growth is clearly the most important one. We are currently enjoying very nice growth with Nubeqa and supported by other businesses which are all growing and profitable in the longer term. Of course, in innovative business we need to have a robust pipeline, out of which we then want to introduce new products and also maintain the good growth momentum in the years to come. As I said previously, we have these many businesses which kind of balance each other. We know that on the innovative side, it's more risky. But then again, the rewards are higher. And then again, in the so-called base business, it's more, how to say, boring. But boring is good in this sense that it is more stable and then brings balance to the entity. But of course, it is fair to say that the base businesses cannot really be such a growth driver for the company as the Innovative Medicines are.

And like I said, we are investing quite a lot in new innovation so that we would have the new growth drivers also in the future. And we have a good track record of doing that. And then again, dividends. As I said, they are an important part of our equity story and especially for the long-term owners. Then if we talk a little bit about the capital allocation priorities, familiar themes. So the two priorities are internal R&D. So innovation. And secondly, also we want to take care of the owners and long-term investors in the form of dividend.

On top of that, of course, we are investing in building and maintaining our capacity. I mentioned that in-licensing is something that we are doing all the time, especially in the generics division, but also in other businesses, and also asset acquisitions. If there's a good opportunity there. And finally, also M&As are in the playbook. However, it's fair to say that we are not looking for any kind of big transformational M&A. It's more like looking for bolt-on smaller acquisitions that would bring some strategic capabilities or know-how to the company. For instance, if we want to expand to a new geographic territory, doing that through an acquisition could be one option.

Then to the clinical development pipeline. If we start from the top, we still have two phase three trials ongoing with darolutamide, or Nubeqa, together with Bayer. And those trials are aiming to expand the indications in prostate cancer. The first trial is due to read out in 27, and then the second one, TASSO high-risk, which is targeting the very early stage of prostate cancer, that's due to read out in 28. Then moving on to our next oncology molecule, which we have completely licensed out to Merck or MSD. MSD is currently conducting two phase three trials in metastatic castration-resistant prostate cancer.

It's good to bear in mind at this point that this indication is something that is not cannibalizing Nubeqa. Nubeqa has never been approved for this indication, and there are no ongoing trials aiming to get Nubeqa approved in this indication. MSD is having two trials. One is targeting or giving OPD5 to the patients as a second- or third-line treatment, meaning that the patients have first received something else. And if that doesn't work, then they are giving OPD5. And the other trial, then again, is testing OPD5 as a first-line treatment, meaning that whenever patients proceed to this stage, they are immediately given OPD5. Additionally, MSD is having one phase two program in metastatic prostate cancer in combination with other oncology products. This trial is obviously aiming to then offer doctors more treatment options in the future, should OPD5 then be approved for treatment of this disease. And finally, with OPD5, MSD started earlier this summer a phase two program in several women's cancers, and that trial is estimated to read out in late 27.

Then there's one cardiovascular program in the pipeline. There our partner in the US. Tenax Therapeutics is developing Orion's old innovation levosimendan, which is familiar from the product Simdax, which was for acute decompensated heart failure. And now, Tenax is developing that molecule for the treatment of pulmonary hypertension with heart failure. They have one phase three trial ongoing which is due to read out second half next year. But Tenax has already said that this trial alone is not likely to be enough to file. And that's why they have announced that they are planning to start another phase three trial by the end of this year.

And in these partnerships, typically Orion's income is the royalties from partner sales. And typically there's also a milestone package included in the agreement. Like I mentioned earlier with Bayer, we have exhausted and received all the possible milestones from that contract. With MSD. We have a significant milestone package up to 1.6 billion USD. And then actually with Tenax we have a smaller package. Typically the milestones are related to achievements in R&D, regulatory processes or then commercial achievements.

Finally, on the bottom of this list is one molecule that is still completely in Orion's hands. So ODM-212, our TEAD inhibitor for the treatment of solid tumors. We have said already earlier that currently we are preparing to start a phase two program in 2026. So next year. And why I'm talking about the program is the fact that this mechanism of action, we see potential in several different indications. And that's why we will be starting several trials, or at least several arms in the trials, next year. ODM-212 could work as a monotherapy, so alone, especially in certain rare cancers, but also in combinations with other products. And there we may have even bigger indications targeted.

And that's not all. Obviously, we've been building our research pipeline for the past many years. It's growing. And actually, earlier this year in our Capital Markets Day, we announced that we are now having Orion's first biologic products approaching the clinical development phase. And in accordance with our Q3 report, we stated that next year. So in 26, we aim to take at least one of those biologics to the clinical stage. And going forward, the aim is that we should be able to feed the clinical development pipeline with our own internal research in a way that we should have at least one new program to the clinical phase each and every year.

And with this, I'd like to conclude my intro or presentation. And then I guess next we will have questions. Thank you.

Thank you, Tuukka. And please have a seat for the Q&A. So let's start with your number one earnings driver, Nubeqa. You have ongoing trials. So could you talk a little bit about what those trials are and if they are successful, how they will expand the indications and grow the market for Nubeqa in the future?

Sure. Good question. So first of all, Nubeqa is currently approved in two indications. So non-metastatic castration-resistant prostate cancer, one could say that it's kind of the mid phases of prostate cancer. And then in metastatic hormone-sensitive prostate cancer, a little later phase. Now the ongoing trials, first of all, the trial that's targeting BCR, meaning biochemical recurrence stage, which is a step earlier from non-metastatic castration-resistant prostate cancer. So we are trying to expand even earlier in the treatment paradigm. And then again, the other, TASSO, is targeting even earlier stages or neoadjuvant setting of prostate cancer. So very early stage of prostate cancer. So if we think about the treatment paradigm, if both of these trials are successful, then we would cover the whole paradigm with Nubeqa, with the exception of the very late stage of metastatic castration-resistant prostate cancer. But then again, there we have OPD5 with MSD. So if that's successful, then Orion products could address the whole treatment paradigm of prostate cancer. And when it comes to the potential, well, we have left that commenting to our partner Bayer, who has previously said that Nubeqa should have potential to exceed €3 billion in market sales, and that should include also the new indications there. However, having said that, constantly they've been commenting in public that actually the development has been even better than they initially expected. So we'll see what happens there.

And this number was given several years ago.

In February 22. 22.

Yes. Okay. And still about Nubeqa. It's an IPR product and there's a loss of exclusivity. So can you talk a little bit about that? So how long will the royalties run?

Yes. Good question. So as you know, in pharma, typically we then refer to the matter-of-substance or molecule patent here. So the molecule patent will expire in the US in 2033. And then in the rest of the big markets, in Japan and Canada, in 2035. So there should be still plenty of years to come before then generic competition could start. And you ask about the royalties? Well, we haven't disclosed the details, but we have said that the royalty income is not related to the loss of exclusivity, but it's related to the start of generic competition.

Okay. And for the new indications, do you have possibilities to expand beyond those years that you mentioned?

As far as I'm concerned, unfortunately not.

Okay. You already mentioned that for OPD5 then, for the late stage, and this is your maybe then in your pipeline the most developed and most late-stage indication. So how is the market for that drug compared to Nubeqa?

Well, again here we should leave the market commenting to our partner MSD. Well, obviously if we think about our great partner, they are a big pharma company. We all know the challenges they may be facing ahead, and that's why they are active in licensing and getting something new. And if we think about the upfront payment, 290 million USD, they paid us in summer 22 when we made the deal. And if you look at the scope of trials they are conducting in various indications, I think that indicates that they are not really after so-called little fish. So the kind of headwinds they are facing, they need to have several big products in the pipeline to compensate that.

And I guess for OPD5 as a phase three asset, the probability of success is statistically something like 50 to 60%, roughly. When will we learn about the top-line results and get hard data on whether this can be a drug or not.

Currently, the estimated readouts for these trials. Two phase three trials. They are in 28.

Yeah. Great. Okay. Then there's a question on achieving sales targets. So what do you think are the biggest risks that you may not achieve the sales target?

Well, it's pretty obvious that, like I said in the presentation, that the growth currently clearly is driven by Nubeqa. So if something would happen on that front, then obviously that would be a risk. But if we look at the growth rates currently and what our partner is publicly stating about the compound, that shouldn't be any immediate risk at least.

Yes. And I think the most recent sales numbers from Bayer are promising, I think. Um. Okay. Um. So then recently, or last year and this year, you stopped the development of two drugs that are kind of mid-stage in development. So what is your plan on kind of filling that phase two area? Are you looking for M&A, in-licensing, or how do you plan to fill up that space after that?

Yeah, it's a good question. Currently we have a lot in phase three and then in earlier phases, but phase two is currently a bit empty. Well, first of all, next year, as I said, we will have several trials or study arms with ODM-212 in phase two. But of course you know that that's only one kind of bet with 212. So obviously we are all the time looking for opportunities, whether they be approaching clinical phases. Phase one. Maybe even phase two compounds. But more likely, maybe phase two-ready compounds.

And I guess this is also a pricing issue, that phase two- or phase three-ready are more expensive.

Exactly, exactly.

Okay. So strategically you're focused on oncology and pain. But if you look at the pipeline, it's very much oncology-focused. So how would you comment on this balance? Do you plan to bring a lot of pain indications and assets to your pipeline?

Well, currently it's very much oncology-heavy. And that will be the case also going forward. Currently we don't have anything in clinical development phases, but we do have programs in the research phase targeting pain. But it's fair to say that the split is maybe 30/70, even 20/80. So more of the programs are in oncology, but pain is still there. But. But with the current stages, it's still a few years until we can get something from our internal research pipeline to the clinic.

So clearly oncology for now.

For the time being.

That's right. You mentioned bringing biologics to clinical development quite soon. I wonder if you could comment on your current assets and observations that are small molecules. Maybe that's a little bit against industry trends. So are there some kind of historical reasons or some other reasons that you have been quite small-molecule focused until now?

Well, obviously it's history-related. The science has been there earlier, but actually biologics is not a very new thing to us. We started to look more into that area and invest in that area already almost a decade ago. But as you know, in this business, the cycles are very long. And now, finally, we are approaching the stage that we could bring them to the clinic. But it's fairly obvious that this is the direction where pharma companies and the industry are going. If you look at the top ten pharmaceuticals from the whole world, I guess nowadays more than half of those are already biologics. So that's clearly the future. And obviously we want to be there creating the future.

One thing that's a little bit maybe surprising in your pipeline is the CAR-T product. For reference, this is a very different type of drug, cell therapy. And you maybe don't have so much experience on this. So can you talk a little bit about why you trust that it's a good idea to bring a very different type of product into clinical development.

A fair question, and we at Orion, we have never kind of been scared of challenges. And of course, it's fair to say that we are not the best experts in every area, and that's why we are having a great network of great partners with whom we are doing the research. So there's academia, there are biotechs, clinics and so forth. So in this specific case, yes, we have certain know-how there. But then we are combining our minds with partners and that way trying to bring that molecule forward.

Okay, so final question for you this year. Well, the US market is the most important one. High prices and large market. And there's been a lot of changes this year. Tariffs and other changes. So what have been the tangible effects on Orion so far. And what do you foresee for the future next year?

Tangible. So far, none. There's been a lot of talk, but nothing tangible. And still, there are a lot of uncertainties related to the tariffs. So currently the situation, as far as we understand it, is that for European or EU pharma companies, the tariffs are capped at 15%. But for the time being, based on our networks and several public sources, the tariffs seem to be paused because, you know, there are these Section 232 negotiations and MFN. So most favored nations negotiations ongoing. So at least to our current understanding, the tariffs are not yet implemented even though they are capped at 15%.

Then again comes that, what's the impact to us? Well, obviously we are most exposed through Nubeqa. We are not having our own sales presence in the US. So our products are imported through partners there, and Bayer is importing Nubeqa there. However, according to our agreement, should there be any tariffs, we will be sharing the impact with the same ratio as we are sharing. For instance, R&D costs for the time being. So if there are tariffs, there will be impact on Orion. But the magnitude, that's still unclear because there are lots of details that are not yet certain. So we'll have to wait and see what happens on that front.

And some pharma companies have been making deals with the US government. But regarding Nubeqa, I guess this is then Bayer's.

They are importing that. That would be then Bayer's job to do those negotiations if that happens.

Thank you very much for the presentation and the Q&A. Thank you. And next, we'll continue with Aiforia.