Orion Oyj (ORNBV) Earnings Call Transcript & Summary

May 25, 2023

Nasdaq Helsinki FI Health Care Pharmaceuticals investor_day 183 min

Earnings Call Speaker Segments

Tuukka Hirvonen

executive
#1

Very good afternoon, everyone, and you are warmly welcome to Orion's Capital Markets Day 2023. My name is Tuukka Hirvonen, and I'm the Head of Investor Relations here at Orion. I'm so delighted to see so many of you here in person today, wonderful that you have made it here to the venue. Good to see you all. And also welcome to all our webcast viewers who are joining us through the webcast. It's also wonderful to see you joining us today this afternoon. Briefly about today's agenda and housekeeping rules. We will have quite many presentations today and 2 Q&A sessions and 1 break. The first break will be after the first Q&A session, which will be approximately at 2:15, and then we will continue also on the webcast at 2:30 finish time. Within the Q&A sessions, we, of course, first like to address questions here from the live audience. I have 2 colleagues here in the venue with microphones. So please, before you ask your questions, wait for the microphones so that also the webcast viewers can hear what you have on your mind. And then, of course, the webcast viewers, you have the possibility to send throughout the presentation or the broadcast questions through the chat function of the webcast. We will also try to address those during the Q&A sessions. However, since we have restricted time, if there will be any unanswered questions during Q&A sessions, we'd be sure that we will address those questions on Orion's website tomorrow or latest on Monday then. We will inform you then when the questions there are available. Hopefully, you will have plenty of questions today to ask. Then continuing with the household rules. I'd like to draw your attention to this disclaimer or safe harbor statement. As you all know, these presentations, they include forward-looking statements, which involve risks and uncertainties. And of course, like always, the actual outcome then might differ substantially from those stated here today. But however, we, Orion assumes no obligation to revise or update any information stated in today's presentations. We will show this slide in the beginning of every presentation, but we will not go through this again. But just as a reminder, this typical safe harbor statement about the forward-looking statements. Then I guess that would be all from my side in the beginning. So with these opening words, I'd like to -- once again, warmly welcome to this Orion Capital Markets Day. I hope you enjoy the presentations and have fun. Our first presentation will come from CEO, Liisa Hurme. Liisa, please, the stage is yours.

Liisa Hurme

executive
#2

Thank you, Tuukka. And good afternoon on my behalf as well, and you are warmly welcome to this Orion Capital Markets Day. And it's a pleasure to see so many of you here in Helsinki and also good to know that there are many people also online. And the usual disclaimer, as Tuukka already went through that. I'm not going to discuss that more. Let's see how this works. So for those of you who have not met me, I think I've met many of you even during this first 6 months in this position. Let me introduce very briefly who I am and where I come from. I have worked in Orion now since 1999, 23 years -- more than 23 years. I originally joined research and development and clinical development. And then mid-2000, I took the first global business role leading the hormone treatments and urology business, which very quickly we changed into urology and oncology. And actually, Nubeqa is one of the, I would say, results of that change in our strategy. In 2008, I started in Orion Executive Management Board, leading the Proprietary Products division. Then in 2014, I kind of jumped to the other side of the fence to lead the generic business, which was called at that time, Specialty Products. And for the last 4 years, I led our operations, which is all our manufacturing sites, both API drug products, procurement, industrialization and whatever has to do with operations. And now after 6 months in this role, I would have to say that it's been really a privilege to take such a role after a long career in a company. It has given me an advantage to do some things a bit of ahead of the time as our new organization and divisional structure that we already announced in last October. Knowing the company very well, knowing the people and seeing how our products have developed, I thought that this is exactly the right time to do it. And I will get back to that later in this presentation. The other thing that really made me happy when I started, was that how dedicated and committed Orion personnel is to their work and to the company. When I started, we did a personal survey, which we do maybe twice a year. And I welcome questions to the new President and CEO and comments, and I received more than 1,000. And I think that's already a sign of commitment that people really want to share what they think about the company. And there, you could see how committed they are. Also, I got many good advice. Then we have world-class partners. Partnering is a very traditional way of working for Orion. Some of our partnerships, like with Novartis, have lasted longer than an average Western marriage these days. So we've been partners for about 30 years or something. And now we have new partners, like MSD and Bayer. And during this 6 months, I've been able to visit these companies and meet the people in my new role, and it's been a pleasure to see how the collaboration, and collaborations are proceeding with our partners. Most of all, we have solid growth drivers, both in our current product portfolio, of which all of the division heads will discuss. And in our clinical pipeline which Outi Vaarala will then share with you later on today. As many of our peer companies, we have experienced patent expiries and series of patent expiries during the past 10 years. That's the nature of this business. That's what you just have to accept. But when we look at how we've actually survived these 10 years, which started with Stalevo, losing its patent protection in early 2010, then followed by Dexdor, then Simdax, I think we've done actually very well. Our net sales have actually grown during that time almost 2% -- 2 percentages as a compounded average growth. And you can see that we've created more than EUR 350 million of growth during that time compared with the EUR 165 million of loss of sales due to the patent expiries. So when you look at it on the surface, you might think that it's all very kind of a solid and [ tranquil ] and even maybe a bit, how would I say, boring, but it's not. I can tell you that when you lose patents for your 3 major products, there is a lot of things ongoing all the time when you need to create a new growth. Then on the operating profit side, we've suffered a bit, and that's self-evident. Simdax and Dexdor were very profitable and are profitable products, and the product mix has changed during these years, so that some of the new products are unfortunately not as profitable. Along the development of net sales, we've also been able to pay dividends each year. It's one of our financial targets, one of the cornerstones in our financial targets that we give at least EUR 1.30 of dividends per share each year. And here, you can see that actually the past years have been even more generous in that regard. When we look at the global pharma market, and I'm kind of moving from Orion figures to global pharma market. But when we look at that market from Orion's perspective, there are 2 notions that you're going to make. One is actually in line with what I earlier mentioned that we've done well. We are a Finnish Nordic company, midsized European pharma company as it is, and our products are sold globally everywhere, in more than 180 countries, either through partners or in our own sales organizations. During past 10 years, we've expanded our sales organization to cover whole Europe. That was done in 2009. We've also expanded into Asia Pacific during the past 4 years. So we are all the time proceeding with our own operations. And of course, as the second message in this picture is that there is a lot to grasp. I mean the biggest markets are still untouched for Orion, and we are all the time evaluating when would it be the right time? What would be the right product? And how would we then enter new markets? The environment where we operate and where we see growth is not getting any simpler. It's actually getting all the time more complex. Of course, it doesn't mean that it's complex only for pharma industry, but there are some things that are very, how would I say, typical for our industry. But what is typical are the megatrends. The growing and aging population establishes a great platform for a pharma company and for a company like Orion. There are diseases, there are conditions that come with aging. And of course, we are there to solve them. Another megatrend that we can see, which is very good for us, is the artificial intelligence and data utilization. Those are things that affect the whole value chain in this industry from the beginning of the research of screening the new molecules to the logistics and manufacturing of these molecules. So we should be able to do everything in a more quick way. It's just a question that how do we take the new things and new technologies into use. Sustainability, a huge mega trend. And now I'm not talking about really the requirements of ESG, which are in a regulatory corner here, but really sustainability in a way that how can a company make this into a competitive edge. And anyway, I think that any industrial company should really take this seriously. It's not like tick-the-box that we've done these things that are required, but that's something that we need to take care if we want to continue to manufacture products and sell products. We need people to do that. We need energy to continue our operations. So it's really one of the most important things for us. Then the global supply chains. I think the pandemic showed us that, that's a tricky thing. The one -- the company that can really match these global supply chains is a winner. This is especially true for the generic industry and for the APIs. And we were really proud of our actions during the pandemic when we were able to deliver at all times to all parts of the globe and drugs that were really saving lives. When we go to the regulatory environment, I mentioned already ESG, and we will hear more about that. Noora Paronen will talk about how Orion approaches this. And also from the other perspective that I already mentioned from a more broader concept of sustainability. Compliance and with compliance creating complexity, I don't mean GMP. That's an everyday thing for us. We've done it for decades, all the pharma companies, but compliance in a wider concept where there are requirements from all parts of the organization and governments to fulfill. And that's something that all of us will need to, of course, do in a very diligent way. And what comes with the aging population, health care cost, pandemic, is a pricing pressure. We see every year that drug prices in Finland, they decrease and decline approximately 10%. And that's clear. That's the environment where we are. But it doesn't only -- it's often thought that these are only generic drugs that are affected. But as we see today, even in United States, where we are very used to say that the prices of drugs actually increase year-by-year. We will see a historical thing happening that prices will actually be cut of innovative drugs. And partnerships, I already discussed. But partnerships, they can make business a bit more complex. We have partners in all parts of our value chain. But I would say that the complexity there is very minimal compared to the benefits that you can gain with your partners and suppliers. We are not going to share any new strategy today. I know when a CEO changes, there are usually questions that when will you launch a new strategy, what will change? And I have to say that the big change was really the change of the organization and divisional structure because that actually supports our current strategy. The purpose was to speed up the development and growth. So we stick to our current strategic targets. We want to grow faster than the market, which we have actually done, or we carried or grown according to the global market growth and then growing faster in certain geographies or segments. And we want to develop the sustainability. And of course, when we grow, it has to be done in a profitable way. Well, I already mentioned the new divisional structure and had some discussions here with some of you before we started regarding on how many countries we already have these days where we operate. And I think that was one of the reasons that we started to change the structure. The other one was really the life cycle of our products. Several of our products and brands have already faced generic competition as we discussed so they need a very different type of an attention at market. Then again, we have innovative drugs. After many years, we have Nubeqa, and then we have something very different like Generics and Consumer Health. So for the Innovative Medicines that Outi Vaarala will share with you, Nubeqa is the main product. But what we wanted to really do is to combine the business and research and development because this division is fully dedicated for development of innovative drugs for people, for humans. So Animal Health will take care of their own. And Niclas Lindstedt will talk more about that. Then for the Branded Products. There, we have our so-called legacy brands like Easyhalers, Stalevo, Divina product family for hormone replacement therapy. And we have long-standing relationship with our neurologist across Europe, with pulmonologists and in some countries still with gynecologist. So we see that there is a lot to take with these products, but still they need a very different type of an approach than the Innovative Medicines or Generics. And to Branded Products, the regions that reported the Branded Products are Central Europe, Western Europe, Southern Europe and Asia Pacific. And we will hear more when Hao Pan will tell about that business division and the growth drivers there. And then Generics and Consumer Health, which is 50% of our revenues, focuses in Finland, Scandinavia, Eastern Europe, and we'll hear also the growth targets in that business. But it's really very distinctive and different from the others, mainly selling products to different tenders, national systems. So all these now will have ability to grow according to their needs and also compete with their peers as they should. And it's not only the marketplace, but will also change the ways we work within a company in the whole value chain. Fermion, still an own company, manufactures APIs for other pharma companies as an external business and then also a very important strategic part of Orion Corporation producing APIs for all of our own products. Maybe a word here about Fermion as it's not separately presented here. What we really saw actually after the pandemic was a kind of a surge and rise for the European API manufacturers. So we really saw the books -- order books filling in. At the same time, we also are manufacturing more and more darolutamide, which is growing fast. So whenever you look at our sales report and quarterly reports, you might see that Fermion is declining a bit, but that's just a very temporary capacity issue of our external sales. And Animal Health, after the acquisition of Inovet, there is 2 -- there are 2 segments. We used to have the companion animals, cats, dogs, horses, that we treated, but now we also have livestock, which is a very different type of a business. It's a commodity business where you sell your products to actually companies or farmers. So how would you call it? So you are a partner to their businesses. And Niclas Lindstedt will talk more about that later on. And the growth drivers, I already mentioned several of them, Nubeqa, of course, for the short term, Orion Animal Health, already discussed, and Easyhalers. That story will hear later on today. And on long term, our new molecules, ODM-208, ODM-105, and 111, and we will hear more how the development there proceeds. In-licensing, geographic expansions, definitely on our agenda. When it comes to inorganic growth, mergers and acquisitions, I think they are mainly a vehicle for us to make the other things happen. If you want to expand geographically, if there might be a good company to do that, that's an idea. But it's not a purpose of this whole growth plan. At this point, I thank you, and I give floor to -- will you, Tuukka, take over here?

Tuukka Hirvonen

executive
#3

Yes, I will take it for you. Thank you, Liisa, for the opening remarks and setting the scene for the rest of the gang. So next on stage will be our CFO, Jari Karlson. He will share his thoughts on capital allocation. And while Jari is coming to the floor, I'd like to remind the webcast viewers that please utilize the opportunity to send questions through the webcast. Thanks. But now, Jari, please?

Jari Karlson

executive
#4

So welcome from my part as well, and good afternoon. So like Tuukka said over the next 20 minutes or so, I will discuss a little bit some background information about our thinking regarding capital allocation and how that is linked to value creation in Orion. Okay. So -- but anyway, let's start from our long-standing financial objectives. Like Liisa already mentioned, we have not changed our strategy. And as a consequence, of course, also the financial objectives are remain the same. So these probably are quite familiar to all of you. So I will not go into the details of those. But I think the good thing to remind everybody again is that they all are important, and they all are linked. So for example, growth, which will be one of the key topics also about my discussion here today, is linked to the idea that the growth needs to also support these other financial goals. So growth without profits, without capabilities to pay dividends doesn't really help us. But of course, the importance of the goals might change over the time when the business environment changes. So there are a couple of kind of background and basic ideas when discussing these topics. So first one is that we are talking about long term, and there are many reasons for that. For example, one of them is that Orion has already been around for 100 years. So we are used to this kind of long-term thinking. Also the R&D, especially the R&D part in this industry is very long term. And also, the -- ultimately, the way to create value is probably the long-term profitable growth. But of course, the ultimate question here is that how should you allocate the capital to really create the best return for the investors and the company. There are lots of different variables. Some of them are internal, some of them external, which makes this consideration fairly complicated. Of course, questions like, how much do you fund R&D, what is the probability of getting something out of that funding and so forth. But also, on the other hand, how well can we communicate and tell to the outside world, show that this picture about our investment is credible to the outside markets. Because ultimately, of course, when we are talking about long-term investments, which means that you invest first and then only years after that, get the return, the markets need to believe throughout that whole period that, that investment mix can change. But that's, of course, fairly obvious, but always good to remind that long-term approach is what we are looking at. A little bit of theoretical slide, maybe, but I think it's good to think that there are ultimately 2 extremes in creating the value, but both are linked to the capability of the company to grow. If the value is created by paying out increasing dividends over the years, that, of course, requires growth. But at the same time, it's also a growth that already has taken place. So you are pretty much giving out the money you already have earned and create value that way. And then on the other side of the extreme is that when you are investing for future growth, you need to create a credible picture to the market, that market believes and values your investments already upfront. Orion is in between here, like, of course, majority of the companies are. But of course, it's very fact that there are also companies who really are very much on one of these extremes of this picture as well. So we've been discussing a lot about growth. And this slide here is fairly kind of a general one, applies to Orion, but applies, of course, to lots of other companies as well that why is growth important? And why are we talking about that? Actually, the same topic was discussed already a couple of years ago in the previous CMD. And at that time, there was no inflation. So the first point here that you need to grow because the costs grow and ultimately, if you don't grow, your profitability will start decreasing, was not necessarily that rule at that time as it has been now over the last 1 year or so. Of course, larger scale of operations means that you can easily carry in this industry, especially quite high fixed cost base that is needed to stay in the industry. Also, it means that you have more resources to develop your business and you can take more risks. And then finally, last but definitely not least, we all know how much there in today's worldwide of good people. So the shortage of skills all around the society is getting tougher and tougher, which means that each company, who wants to attract the best people and retain them, need to be able to provide them good opportunities. And without growth, that is definitely much, much more challenging. So growth is also needed to create the basis for all of these other things. A couple of other considerations still before then moving more to actual Orion specific topics. Of course, if we talk about market value, there are also items like the discount rate or interest rates used in devaluations, which impacted every company's valuation. That is, of course, completely beyond our control. Also, I think, at least, I would say that if your strategy is very much based on high multiples and future growth that probably creates quite a lot of more volatility into your share price. So even small changes in the views of what happens in the future can actually have quite a major impact on your valuation. But in long run, I think it's -- at least in Orion, that is the case, and I assume that it's in all of the other companies as well that the total shareholder value, market capitalization and profits tend to be fairly close to each other. There are a couple of slides which are pro forma type of calculation from Orion's history, which calculate from -- starting from 1990 and starting from year 2000, the combined average growth rate of our total shareholder return, market capitalization and EBIT. And as one can see, when time scale is long enough, they tend to be fairly close to each other. But also in these slides, one can see that dividends have had a big important role over the history of Orion shareholder value creation as well. So capital allocation and value creation in Orion, what has historically been the case. So our total shareholder return in really long run has been a little bit more than 10% per annum. So around 11%. And if we would have reinvested dividends, that number would have been a couple of percentage points higher. So fairly decent return. Our PE ratio in the past longer period actually has not been that dramatically high compared to many other companies. But currently, of course, it's relatively high. So we are in roughly 30%, which is quite in Orion's history also one of the highest points. Our dividend payout ratio typically is quite high compared to most of the other pharma companies. But as a combination of these 2 earlier points, we currently are actually in a situation that even though our payout ratio is quite high, our dividend yield actually is not any more that large. We are talking about maybe 3% or so, which is okay, but there are lots of other investment opportunities with much higher dividend yield than Orion. Okay. And then moving maybe a little bit more closer to what we are thinking in Orion. So what I have been discussing so far has been a little bit more of a background of the thinking. And I discussed that growth as such is for most or almost all companies, very crucial. In our case, what brings an additional element there for the next years is the fact that we are assuming that the company actually can grow quite nicely because of Nubeqa. But at the same time, in this industry, where all of these products at some point lose the patent protection, we are in a situation that we ultimately need to find and utilize the capital money earned from Nubeqa to create new business, which then can not only replace, but actually continue growth of the company. And Liisa, in the slide, she showed what happened after especially entacapone lost the patent protection. And it has been a tough job for Orion for the last decade or so to replace the declining sales of entacapone. And if Nubeqa is at all as successful as we believe it will be, we are facing much bigger decline in sales and profitability than was the case after the Parkinson product line lost the patent protection. So we need to be prepared. And when we think of the ways to prepare, of course, we could just let all the profits go down, increase profits and pay more dividends, which might be very nice for a while. But ultimately, like when I started, I discussed that we are talking about long term, that would be in long term, quite a strange strategy. So we need to be able to reinvest big amount of that money into something. And there, of course, we are then talking about basically 2 different areas, which I will then discuss a little bit more in the coming slides so we can increase our R&D spending and our sales and marketing spending, grow the business and create shareholder value. And we can do something inorganic to support the business to get access to new products, new sales, new geographical regions and this way, grow the business. So these are not -- we either do this or that, but they are basically just 2 kinds of ways of utilizing the capital created by our growing business. First, a little bit about the R&D and the linked commercialization. So the assumption here is that in the previous slide, the first slide that you just grow dividends and this way create value is not sustainable in the long run. Our payout ratio is already quite high. So at least that is not a possibility to create more value because we pretty much are already distributing such a big part of our net income every year. So it has to -- the long-term growth needs to be based on our capability to grow the business. And one way of doing that is definitely higher [ RN ] spending and then also, of course, for example, acquiring new products. One of the challenges with that approach is, like we have seen in the past, is that we have been able to create very, very good production from our R&D. But as long as we always end up only earning the royalties out of those [ inventions ], I think I can say that in my opinion, the risk adjusted return in the long run is likely not high enough. If you only earn like 20, 25, 15, 20, 25 type of percentages of your inventions and taking into account that for many of the R&D programs over the years anyway, fail. It's very difficult to create good enough valuation, unless you also are able to get a higher share of the value of those products yourself, which then means that we need to find a way to commercialize the products, maybe not globally, maybe in only in certain regions, but anyway, in larger territories than what has historically been the case. But then, of course, we are facing a fairly complicated and challenging question that then, when you don't partner or give out the regions, then of course, you cannot find somebody to share the R&D costs with you, then you also need to be prepared to finance the launch of the product, the commercialization of the product, which means that there are going to be many, many years before you start seeing the returns when you only have to invest. And like we all know, not all of those programs you have succeed in R&D. And even if you succeed in R&D, it's not 100% guaranteed that they will be fantastic commercial successes. So there are risks involved and the timing of those spending and the returns is the one where we really need to find ways. And here, the assumption is that we most likely need to find a hybrid approach. Gradually, we need to be able to get larger access to markets ourselves. But we also need partners. But the partnering doesn't necessarily always need to be something which we traditionally have been doing, like going out with a big pharma company and licensing out the product. There are also other alternatives. There can be joint ventures. There are also vehicles available in the world where, for example, private equity type of companies are funding, participating in funding of R&D programs and so forth. So we need to find an approach, which increases maybe somewhat the risk we are today taking, but at the same time, leaves us more than we today are earning. A little bit -- few words about the M&A. So we currently have probably low debt taking capacity of something EUR 400 million, EUR 500 million without sacrificing our financial target of 50% equity ratio. We also have been given the right or the Board has been given the right by AGM to issue new Orion shares. And of course, if you then want to maintain that 50% equity ratio, if you get more equity, you can, of course, after that also raise further new capital or debt from the market. And of course, assuming that the profits of the company will continue growing, and we don't distribute them all as dividends also that, of course, increases the equity. It increases the funding capabilities and so forth. So we most likely are somewhere in 1.5 billion, probably a little bit more as the time goes on to utilize for acquisitions, which taking into account our history is really a lot of money. On the other hand, of course, it's also clear that in this industry, if you have 1.5 billion and you are talking about Orion size of a company, even with that money, you cannot do something which completely changes the company. So even this much of money most likely means that we can target things that support our business. And like Liisa said, that has been our thinking all the time. If we think of how much risk there is involved in the M&A, I think it's fair to say, especially if we are talking about new [ interventions ] that R&D has higher risk than acquisitions, especially if you are talking about the company, which already has sales in the market. On the other hand, the upside potential of R&D definitely is higher because if you do an acquisition, even if you are buying a company that is growing, most likely fairly big part of that growth is included in the pricing of the asset you are acquiring sold. The upside potential, unless there is something really unusual case, is typically also somewhat more limited. How to mitigate the risk? Of course, if you don't put all your money in one acquisition and do a little bit more supporting acquisitions, the risks probably are somewhat less. Of course, we all know that in sometimes more acquisitions, large acquisitions, they require exactly as much work in the integration and in the process. So it's not that self-evident. But also if you buy something where there really is already existing sale that, of course, helps us well. Then, of course, if we are talking about acquiring assets in R&D, then to some extent, you, of course, are combining the challenges of both of these approaches that there are high R&D risks, and there are this M&A risk, and that's why it's likely that the capital allocation to those type of assets will be somewhat more limited. And then finally, a couple of key takeaways. So profitable growth, I think, is, in Orion, like it is in all other companies as well, the way to increase value because Orion is not a startup, but an established company, we need to take care of today, not only the long-term future. So the capital allocation needs to find a balanced way between today's returns and long-term returns. Selective M&A definitely can't be utilized, but the risks with that and risks with also this timing challenge with commercialization and own R&D can be managed with good and creative partnering, finding new ways of supporting this growth. And then the dividends have played a role, and I assume that it is still also a fair expectation by our shareholders that Orion continues to pay dividends. Even though, of course, in our capital allocation ideas, the payout ratio will gradually go down if the company's profit levels increase. But having this financial target related to dividends will be there in place, I'm certain also in the long run. But that's kind of the thinking. No answers yet. What are we going to do exactly with the capital, but some of the framework, how we are thinking about that and what are the important things. And the capital allocation needs to support growth because of the growth, but also especially in our case, because we need to be prepared for the time when Nubeqa is no longer proprietary product.

Tuukka Hirvonen

executive
#5

Thank you. All right. Thank you, Jari, for the presentation. And next, it's my pleasure to invite to the podium our Head of Corporate Responsibility. Mrs. Noora Paronen. Noora, please, the stage is yours.

Noora Paronen

executive
#6

Okay. Pleasure to be here, and welcome to also from my behalf. So I'll walk you through the sustainability update. So we, as a company, have done really systematic work on our sustainability strategy that we call sustainability agenda. So our approach covers the entire value chain from the R&D to manufacturing to distribution, use and disposal. So we have -- we are focusing on this for themes that we have selected based on the stakeholder dialogue, including the investors. And for all of these 4 themes, we have set concrete actions and also have the targets in place and following the progress. We, as a company, are also -- well, we want to promote also transparency. So of course, we are reporting on these key topics in our sustainability reporting. But also, we have -- we are reporting to a selected number of ESG ratings as well. So for example, we have been recognized by the Carbon Disclosure Project on the management level for the water and climate, and also Orion is listed as one of the climate leaders in the Financial Times listing as well. So what is happening is that there is a huge and unprecedented level of different type of sustainability disclosure obligations coming, that are then something that the companies need to comply with. So this means basically that there's something that used to be a kind of soft [ law ], voluntary to disclose, is becoming mandatory to disclose. Also, at the same time, the reporting needs to be integrated as part of the financial reporting and as well the way companies need to report will be more formal. So we have a really strong base to meet the requirements. So our last sustainability report was actually the 14th report. Our report is based on the GRI standards, and we are already limitedly assuring by the third-party our reporting. So the 2 big things that are coming. First of all, it's the EU taxonomy. So it is the EUs classification system to companies to identify the environmentally sustainable activities. And then us as a company to disclose those. So first set of disclosure obligations is already implemented at the company, and we are disclosing that we are climate-neutral company. So that means basically based on the current taxonomy criteria that we do not see is -- and we are not seeing a substantially contributing to climate change or to be an enabler to mitigate it. The next thing that is coming is that there will be a next set of the taxonomy disclosure obligations for the 4 new environmental objectives coming. And that will apply to Orion this fiscal year. The second thing that is then also coming is the corporate sustainability reporting directive. A huge set of requirements that the companies need to disclose on. And we have been developing our reporting over time, so we are well prepared. And for example, one of the requirements that is in the CSRD is the assurance that we already have in place. So what we are doing to meet the requirements is that we are developing our reporting further. So for the EU taxonomy, the thing that is then also applying to us in this fiscal year. So that means that Orion is seen according to our preassessment, we are -- some of the economic activities. So the API manufacturing and the pharmaceutical manufacturing will be taxonomy eligible. So we are preparing the reporting to -- in that regard. So seeing that the pharma companies, what it actually then means is that when we are saying that we are eligible for the pollution prevention and control, it means that we have possibilities to then to prevent these things that we are then reporting on. For the next thing that is coming is the CSRD, so we are also preparing, and we have made the gap assessment already. And one of the things that the companies are required to do is this double materiality assessment. So we have that already made. So we, again, had a dialogue with our stakeholders and identified 17 relevant material ESG topics. And for all of these topics, we made an assessment. So basically meaning that the -- what's the impact of those ESG topics on the people and the environment. So for example, the climate emissions that we, as a company, have. So what's their impact to the people and environment. And then again, we had to and we have assessed what those material ESG topics, what they do to our financials based on the risks or the opportunities. So for example, for the climate change, so we are seeing that we have assessed that, for example, the physical risks related to the climate change, what type of financial impact it might have or then on the other side, the opportunities, such as our Easyhaler business, what that might have on the financial side. So we have created this kind of map as well already. And we -- this transparency that is then being driven here and to having kind of the consistence in different types of disclosures among the companies, that is then intended to help also the financial markets, to then take these considerations into account in their investment decisions. And then also to kind of incorporate these ESG-related risks to the decision-making as well. So that's kind of from the reporting perspective. So that's something that we need to nail and that we are well -- very much well prepared. But then again, we also want to focus on the material topics as well to go forward and continuously improve also our ways of working. So as an example for the climate, so Orion has been committed to achieve the carbon neutrality of our own operations by 2030. And we have steps towards the target in place, and we are really progressing well. So we know our impact, and then we have identified and made road map how to then to achieve our target. So the actions that we are making, so the concrete actions. So for example, we are continuing still the improvement in the energy efficiency. We are purchasing the carbon-free electricity. And we also know that to be able to hit the target by 2030, it might also mean that we need to make investments. So we need to invest on the electrification of our certain processes at our factories. So basically, how we are then creating, for example, steam and heat. So we are on the way. So by now, so we have already decreased 60% of the greenhouse gas emissions. So our own company's carbon footprint compared to the baseline 2016. And in the end, so Orion is about making concrete action. So by far, we are then focusing on the concrete actions and then only the unavoidable emissions we will then, in the end, compensate. But as we know as a company that it's not enough that we are only securing our own operations. It's only one piece of the puzzle. So we also assess the kind of the whole carbon footprint of the company across the value chain. And -- so what we are now doing is that we have also committed to reduce the climate emissions across the value chain and also set the science-based targets, so the SBTs. So meaning that we will align our business to limit the global warming to 1.5 degree celsius. So we want to do our part. Although we were seeing as a kind of climate-neutral company in taxonomy wise, it doesn't mean that we wouldn't want to do things that are right. And this is something that also our stakeholders have been expecting of us. So the climate change is still one of the material topics that we also now -- our reassessed material, the assessment, so that it's still there. So we are setting the SBT targets. So first of all, we are seeing and securing that this green box over there, that is illustrating our own emissions that those -- the road map that we have made, that's also based on the science. And then again, it will be in more detail about bringing this blue box down. So how we'll do that in practice? So we already know and have identified our high-intent suppliers. So we are engaging with those suppliers to reduce their emissions. So in practice, it might be that we are requiring them to also to set their own SBT targets, and when going forward, we see here that also one of the great ways of how to get people on board. So basically getting the whole value chain board that we need to do to be able to hit the targets is that we need to engage with them. We need to have a dialogue with them through our supplier relationship management meetings, for example, and to share the best practices, how we have, of course, also been decarbonizing our own operations, and we have some great examples there. So this is a journey that we have taken, and we are moving forward. So for example, the investors are seeking that we are aligning our operations to SBTs, and we are committed and we are making the targets and sending them also to validation, but this is something that also our customers are asking from us, some of them. And also the employees. So great to see that everybody are in line and moving towards the same target. But lastly, I wanted to give you here also kind of a glimpse or -- that kind of focus on our continuous improvement programs in our sustainability agenda, where we want to really make a difference in different type of sustainability matters across the material topics. And one of them is kind of a new topic that has been popping up is the biodiversity and ecosystems conservation. So this is kind of a crisis comparable to climate change as well that we want to -- that calls for solutions, and we want to be on board as well. So -- but kind of for the climate, the path is well known. So we know for the fact that for the biodiversities the path isn't yet a bit unknown, but we are ready to get into the pathway and then to initially map the impact that we, as a company, have or then what our value chain has as well. So we have committed to work towards the no biodiversity or no nature loss caused by our business or our value chain. And we are already on our way. So some of the pieces and puzzles -- pieces of the puzzles are already there. So for a pharma company, biodiversity is very much linking also to the pharmaceuticals in the environment. And there, again, when we are talking about our own operations, so we have responsible practices of how to treat the waste and waste water. But we are also monitoring and assessing our global supply chain, how they are also then doing the same in their end as well. So some of the pieces are already there, and we have systematic practices and processes in place that we are then applying across the supply chain. What we see now kind of -- we want to get into this journey as well. So also map the biodiversity impact as a whole from a wider perspective and see how we can then also contribute, and this will then in the end also building to the EU taxonomy. But that's the key takeaways. So as I said, so there is really tremendous amount of different type of regulation coming and not only in sustainability as a whole, but then -- specifically today, we talk about only the reporting end. But we are really well prepared, and we have a strong basis how to build the continuous improvement also in that and further. We are promoting the high-quality data as well and promoting the transparency that I've seen and hopefully helps also the capital markets community to get an understanding where companies are and getting the kind of consistency across the different levels of disclosures that the companies are then handing out. And lastly, I wanted to kind of say that it's not only about the reporting. So we need to have processes and practices in place, and that's something that we are doing all the time, having a continuous improvement, focusing on also the material topics that we actually have then also something to report on. Thank you.

Tuukka Hirvonen

executive
#7

Thank you, Noora. And now I would like to invite Liisa and Jari on the podium as well. So it's the first Q&A session time. So the floor is open for questions. So if you have any questions here, at the venue, please raise your hand and wait for the microphone to come and then you will have the question. First question comes from the not line, but live Harry Sephton, please.

Harry Thomas Sephton

analyst
#8

Thanks, Tuukka. So my first question is for Liisa. One of the most important things you've done since becoming CEO is the reorganization of the divisional structure. I just wanted to get your thoughts on the more focused divisional structure, and the trend across pharma companies for deconsolidation. So a lot of pharma companies have seen a lot of deconsolidation and championing the benefits of more focused operations following the reorganization of Orion. Can you maybe talk through the synergies that you see between the current new, more focused divisions and your thoughts on deconsolidation?

Liisa Hurme

executive
#9

Well, clearly, the purpose of the change was really to be able to focus more, as you said, so that each of the divisions can really operate as they need to do at the marketplace. And the divisions that contribute more than 80% for their net revenue belong to that division. So it's also kind of an accountability to deliver what you promised. Then the deconsolidation. I don't see any -- the reorganization is not the predecision for deconsolidation, I would say, if you are looking after that. I understand why you ask it, and we've seen a lot of those. The purpose is really better positions for growth. To get most out of each of the product portfolio and division.

Harry Thomas Sephton

analyst
#10

Can you hear me? So my second question to Jari, on your comments to invest in OpEx. Could we expect that despite the growing contribution from Nubeqa royalties, which obviously very high margin to Orion, would you expect that you will continue to target this 25% operating profit margin target and so limit the margin expansion going forward?

Jari Karlson

executive
#11

Well, I mean, that is one of our targets today. And of course, for many, many years, we were even above that line. Now we have been slightly below with the exception, of course, last year when the ODM-208 deal was one timer. But like I said in my presentation, it's really a question of the long and short-term balance that you don't want to sacrifice your long-term opportunities only because you simply don't want to use enough money today. On the other hand, of course, one needs to be able to justify those investments in order to create a credible picture that they really create the long-term return. And that is the challenge. But the target is definitely still there. We want to be a highly profitable company. And I think our multiples in the capital market also expect that we continue to be a highly profitable company. But whether that 25% is something we need to achieve every single year, I think that's not the question there. That it's the target where we want to be and there might be years where, because of the timing of the investment needs that sometimes there is some fluctuation, but definitely, the long-term goal is there to continue to be a very profitable company.

Harry Thomas Sephton

analyst
#12

Brilliant. And then just my final question before passing on. You mentioned about accessing or -- yes, accessing new markets. Just wanted to get your thoughts on which markets you're prioritizing? And what might be the notable catalysts to enter into those markets?

Liisa Hurme

executive
#13

Well, I think we all know that the U.S. is the biggest single pharma market on a global basis. And we -- all the time, we think you know what -- or evaluate what would be the right time, as I said, what would be the right product to enter that market with whether -- I can say whether it would be the ODM 111. Maybe it's a hybrid solution, a bit like Jari presented in his presentation that maybe it's one indication of partnering, maybe it's a different type of partner agreement where we then would be able to commercialize some indications at the U.S. for that molecule or some other molecules. So I think it's work under progress all the time and it might have a hybrid solution that differs probably from the earlier ways of developing these global molecules.

Jari Karlson

executive
#14

That, of course, would be the big markets, but we already expanded to Asian market, for example. And of course, the idea is there maybe value add a little bit like we have done over the decades in Europe, gradually, step-by-step, expanding the operation. But of course, U.S. would be the big jump. The other geographical expansion would be more like gradual step-by-step approaches.

Sami Sarkamies

analyst
#15

Sami Sarkamies, Danske Bank. I have 2 questions, starting from Liisa. You said that the company's strategy will not be revised. But if we dig a bit deeper, what is different in the Orion thinking today versus 2 years ago?

Liisa Hurme

executive
#16

Well, I need to correct my [ say ] here. I can't tell you that the strategy will not change. We are right in the middle of strategy process, but we thought that we'll follow our processes and do it as we were planning to do. I was saying that currently, we still have the strategy that we've been applying, and the purpose really is now to speed up to achieve those targets.

Sami Sarkamies

analyst
#17

Okay. And then I have a question to Jari. You spent time on capital allocation. If we think about M&A and sort of planned bolt-on acquisitions, will this ultimately be funded from future dividends by lowering the payout ratio? Or do you actually think the company should carry debt in the long term?

Jari Karlson

executive
#18

Well, like I said, showed in the calculation, which showed both the potential for raising new equity and debt. So I think if you only want to find acquisitions really, really, really through operational cash flow, there would be a fairly small one because throughout my presentation, I clearly also said that we definitely will continue paying dividends. Of course, ultimately, I mean, it's difficult to say that who funds the funds even if you take debt. At some point, you need to find ways to pay back that debt or raise new debt. So of course, they all are connected. But definitely, if we go with the acquisition, like actually we did, I mean the Inovet acquisition was not a fairly really large one, but still we ended up taking some debt to fund them on as well. So definitely, it's both needed. But at the same time, of course, I guess, it's fairly obvious that if you pay all of your net income all the time and all of your free cash flow out as dividends, then, of course, it's fairly difficult in long run to fund any kind of an acquisition. So that's not the purpose either in the future.

Iiris Kemppainen

analyst
#19

Iiris Theman, Carnegie. Can you comment what kind of growth do you aim to reach beyond 2025? And are you planning to give kind of 2030 sales target at some point?

Liisa Hurme

executive
#20

Well, as I said earlier, we are currently really planning beyond the 2025 and even beyond the 2030s. But I'm not going to give any number at this stage. The growth, of course, will continue, hopefully, even on an accelerated curve, but it's a bit of the same like with the profit target. The growth is not always linear, you know. So there might be years when it's really fast or even kind of the 3-year periods. And then, of course, due to the launches in certain territories or other actions, it might then stagnate a bit. But to answer that, you would probably need to wait for a while.

Iiris Kemppainen

analyst
#21

Secondly, you gave a peak sales target of over EUR 200 million for Easyhaler. So firstly, has something changed? Or why -- I think the target is probably a bit more positive than you have previously indicated. So what is behind your thinking? And secondly, does it still mean that you aim to grow at a single-digit rate, as I think you have previously mentioned.

Liisa Hurme

executive
#22

Yes. The Easyhaler, we really increased our understanding, told to the audience that we think the potential is more to the EUR 200 million than to the earlier one. And not jumping ahead of the things. Mr. Hao Pan will share some light on the changes in the marketplace. And why do we see that there is a higher potential there? And were you referring as a single digit for cooperation numbers?

Iiris Kemppainen

analyst
#23

For Easyhaler.

Liisa Hurme

executive
#24

Well, I think we'll hear more about it.

Iiris Kemppainen

analyst
#25

And then finally, just if you enter the U.S. market, so can you share your thoughts how much it would cost?

Liisa Hurme

executive
#26

Well, I think it would definitely depend on the solution. As I said, it might be a hybrid solution. It will have several different phases depending on the indication that you would commercially enter into how big is your customer segment and all that. So it's very difficult to give a certain number on that.

Jari Karlson

executive
#27

But it will cost a lot. I mean that -- I think it's clearer because that's -- that is exactly the reason why we have not done it already in the past because it requires so much higher investment than in any of the other single markets. And that's why we really need to be certain that we have the right tools in our hands to do that. But it will require a very, very long-term commitment to that market. You cannot go there and then just leave if it doesn't work out in the next year.

Tuukka Hirvonen

executive
#28

All right. Do we have any further questions here at the venue? If not, then we will have a couple of question sets coming through the webcast. So the first one is regarding Fermion, and this is coming from Jo Walton from Credit Suisse. So thanks, Jo, for your question. So Liisa, in your speech, you mentioned a spike in EU demand for APIs around the pandemic. Do you see that this is being sustained? And if it is, would it be worth increasing investment to Fermion to increase the contract manufacturing business there? Or are the cost levels are just so high that it makes no sense to compete, for instance, with the Asian manufacturers?

Liisa Hurme

executive
#29

That's a very good question, that is the demand really sustainable? We saw the surge of demand during the pandemic for the European APIs. But I think it still continues to some extent, not as much as we saw it during the pandemic. Unfortunately, I think that the price pressure in the European and all the Western markets for the generics drugs, especially drives the API industry to the Asian prices. But I'm sure that if any Western API company has a very good process and large volumes and new focus, you can also do it in Europe, and it's worthwhile to invest in Europe as well.

Tuukka Hirvonen

executive
#30

Thank you, Liisa. Then the next one comes from Viktor Sundberg from Nordea. So his focus is on the generic business. So looking at generic companies, in general, they have, of course, been pressured by high cost in raw material, transportation, energy, et cetera, from late 2020 until today. At the moment, what is your view on these cost challenges of your Generics business? Do you see them peaking now and moving down?

Liisa Hurme

executive
#31

I think -- I'm sorry, I think we saw the peak actually during the last autumn in Orion, both in Fermion and in the Generic business. But we estimate that first -- the total first half of this year will still be on a higher level, and there are still increased prices, both on the volumes. Energy has come down. So that's at least something that is good. We hope nobody really knows at the moment, but we hope that at least it stagnates that the costs are not increasing on the latter part of the year.

Jari Karlson

executive
#32

I think that's a very important point is that even if the increase is now slower, it doesn't mean that very soon, we will have cost levels, which we saw a couple of years ago. So many costs will remain at a higher level than we were used to in the past. Some like energy, yes, they actually might come relatively close to where they were, but lots of other things will continue to be higher. But at least the growth is [ flowing ].

Tuukka Hirvonen

executive
#33

Thank you, Liisa. Jari, you already answered one of Victor's follow-ups, but still one more. How insulated are you from these challenges, these cost challenges versus your peers in the Generics business?

Liisa Hurme

executive
#34

I don't think we are insulated at all. I think it really all these pressures, they affect everybody in the industry.

Tuukka Hirvonen

executive
#35

Thank you, Liisa. Then we still have time for a couple of more. This one comes from Graham Parry from Bank of America. So what are your key targets and metrics for M&A?

Liisa Hurme

executive
#36

Good question. As I say, the M&A is not something that we would push for any price. And I'm not mean the price of the acquisition. It's more of a what do we really need? And it might mean a vertical integration in our generic industry, it might mean R&D center for development of, say, Generics or Animal Health products. It must be something that really builds our capabilities and builds a platform for future growth. I think that would cover that question.

Tuukka Hirvonen

executive
#37

Follow-up. That -- would this be then primarily R&D products that you are targeting?

Liisa Hurme

executive
#38

No. I think it's really more of a capabilities either on the commercial front, new geographies or product -- commercial product portfolios or then, as I said, it's something to do with the whole supply chain or value chain to build up some competencies there.

Tuukka Hirvonen

executive
#39

And the final follow-up, of course, is actually probably to Jari. So are you happy to do an EPS dilutive share issue to finance and pipeline deal? Or would deals need to bring profitability to offset the share dilution?

Jari Karlson

executive
#40

Of course, I mean, in principle, I guess it's easy to say that every acquisition should add value. But then, of course, it comes again to this timing questions that, will it immediately do that? Will it do it longer run? And that, again, on the other hand, it depends on the type of acquisition you are talking about. But definitely, of course, the share issue will dilute. And that's why one needs to be very careful in using that, that the target for that money should really be so good that it actually can more than compensate the dilution when you issue new shares.

Tuukka Hirvonen

executive
#41

Thank you, Jari. Noora, congratulations. You emptied the table with your presentations and no questions for you at this time. Thank you all for your questions. It's good to see this interaction between the audience and presenters. Now here in Helsinki, we will hold a 15-minute coffee break. So for the webcast viewers, please rejoin us at 2:30 p.m. Finnish time, and then we will have the next set of presentations online. All right. So 15-minute break now. Thank you. [Break]

Tuukka Hirvonen

executive
#42

Nice to see and so much of the webcast viewers. We are ready to begin our second set of presentations. And the first speaker will be Outi Vaarala, the Head of our Innovative Medicines business division and also Orion's Research and Development. So it's my pleasure to invite Outi at the podium. Outi please, the stage is yours.

Outi Vaarala

executive
#43

Thanks, Tuukka, and it's a pleasure for me to be here and update you about our Innovative Medicine business unit and Research and Development today. And here, we have the important disclaimer, particularly important when I'm talking about Innovative Medicines. And Liisa already touched the basis how -- why she wanted to create the new structure for us. I personally think that this model and this structure is the best way to work in R&D and with Innovative Medicines. If you have R&D working together with business from the early idea of the project to the launch of the asset, I think that, that's the best possible way to reach the right patients for your assets. And in this model, we can now work according to the business model. That is the best fit for Innovative Medicines and in R&D, the approaches, the activities we are doing in Innovative Medicines business. Of course, those activities are very different from those that we do in generic medicines development. So I think that this makes sense. And it also gives the opportunity for us to be most successful. On the left-hand of the slide, you can see the net sales for the first quartile, '22 and '23. You can appreciate almost 90% increase in the net sales. We will see that kind of increase for our innovative medicines during the following years. And Nubeqa, the old trend, is the major driver of this growth for us, as you can see. But we have more to come. Let's first use some minutes for darolutamide, discovered by Orion R&D and marketed with brand named Nubeqa by Bayer now. We have seen the success of Nubeqa in the first 2 Phase III studies, ARAMIS and ARASENS. We have still, in our pipeline, together with Bayer, 2 Phase III studies ongoing, and we aim to expand further the indications for Nubeqa in prostate cancer. And this is the basis for our growth during the following years. This gives the opportunity for our R&D, for our Innovative Medicines business to do something that currently is further growth beyond '25. Here, you can see the milestones and royalties for us during this early time of the collaboration. And you can appreciate that the numbers are higher in the future, of course. So the short-term growth is based on Nubeqa mainly. We still have ganaxolone there. We will get CHMP EMA's opinion for the market approval application very soon for that product. It is a product which is much smaller than Nubeqa, but it's very important for the patients with severe genetic epilepsy. Mid-term growth is perhaps the most important part in this slide. And I'm very proud of the assets we have there. We have, of course, Nubeqa, but then we have our ODM-208. It has shown a signal of efficacy in our Phase III -- Phase II studies already. We have ODM-105, our alpha 2 receptor agonist there. We have ODM-111, our asset to tackle pain. And this is extremely important asset for us. And again, we have a solid basis for this project in our clinical pipeline. We know that this target NaV 1.8 is validated for pain treatment in preclinical models and also in early clinical studies by Vertex. And that's the reason why I can say that our midterm growth is based on the assets that are solid, and I can talk about this freely and confidently. We have also here a new asset to be announced for you today, ODM-212. I will talk about that a little bit later. It's a TEAD inhibitor aimed to treat solid cancers. And in the long-term growth, then when we go beyond 2030, we have our robust research project pipeline that will -- where the projects will move towards clinics, and I will talk about that also later. Research and development, we focused last year our R&D activities so that now we are working in therapy areas of pain and oncology. And I -- once again, I want to tell you the reasons behind that. We have a proven track record of success on in discovery and development of Innovative Medicines in oncology. For cancer patients, we have darolutamide and ODM-208. So it was like a solid platform for us to build on that. And we decided, of course, to stay in oncology and expand our research beyond hormonal cancers. So that's easy to understand. But then it was more difficult decision for us to leave other neurological disorders and go only to pain. We have a long history of pain research at Orion. You remember, we have been forerunners when it comes to [ TRPA1 ] ion channel as a possible target for pain medications. And it was a natural thing for us to do this in-licensing of ODM-111 assets because our own research and literature sold that NaV 1.8 ion channel is an important modulator of pain. And this is a non-opioid pain treatment, maybe a game-changer in pain treatment. Well, ODM-111 program, when it succeeds, it's a large broad program. It includes a good pain and several indications of chronic pain. We wanted to be sure that we can give the best opportunity for this asset. And because of that, we decided to put our resources in the field of pain to bring ODM-111 to the clinics in the best possible way and at the same time, nurture our pain research and oncology research with the best resources. We have very good scientists there. They need the best resources so that they can be competitive. And I have always said that drug discovery is successful when it's based on science, scientific understanding of disease drivers. And we want to be the best also here, and that's the reason why we did this focusing. At the moment, we have around 400 R&D employees at Orion Innovative Medicines, R&D. And our expenses in 2022 for R&D were around 10% of the group's net sales, high percentage when you look at the Innovative Medicines net sales, and this is going to continue. We are building our pipeline. We are building our future growth, and that's the reason why the expenses are high in comparison to our net sales during the following years. As I said to you, we have, how would I say, a very high threshold for our ideal level projects to become research projects. And we want to keep it as it is because we want to have high probability of success for our projects. We want to have our research projects already as solid as we can have. At the moment, we have 8 research projects in our research project pipeline and about 3 of those will deliver candidate molecule during the following 12 months period, meaning that we have again after 2 years, at least 3 clinical new projects in our pipeline. Pain research areas, ion channels are still there, important regulators of pain signaling. And then we are now putting a lot of resources to fund science and research for identifying disease drivers of different pain phenotypes. Phenotyping of pain is now important for everybody in order to have more targeted treatments for pain. And neuroimmune interaction is one area in our interest. In oncology, as I said, we have expanded beyond hormonal cancer, cancer genomics, cell signaling is in focus. Also immuno-oncology is very important now for us, particularly, we -- when it comes to second-generation immune checkpoint inhibitors. We have also a group working with antibody truck conjugates to find better treatments for cancer patients. We are nothing without collaborators. And you can see here that we have collaborators that are important for us when it comes to the new modalities, when it comes to the development of antibody-based treatments and so on. We are also, as many other companies working with AI and machine learning approaches to speed up our discovery, and we have collaborators helping us there. And also academic collaborators are important. After our latest CMD, we have here delivered 3 new clinical projects, ARASENS, darolutamide, new Phase III study, ODM-105, and then ODM-111 we talk about. So I think that we have a solid progression in our clinical pipeline. Some words about ARANOTE and ARASENS that are ongoing. ARANOTE is a study where darolutamide is tested in metastatic hormone-sensitive prostate cancer without chemotherapy. And we will have the readout '24 launch '25. That's the plan we have together with Bayer. ARASTEP is a study where we approach the early line patients in whom we see biochemical relapse of the disease. And this patient group is, of course, a big one. And there, we hope to have the launch '27, around '27. Some words about ODM-208 it is discovered by Orion Scientists and developed by our R&D now to the Phase II, which is still ongoing, and we partnered this molecule with Merck last summer. The plan is to proceed to Phase III studies by the end of '23. We have published and revealed some data immature data, but still important data in the last ESMO meeting last September. And I will show you just some data where you can see the efficacy signal of this molecule. In this Phase II study, 50% -- more than 50% of the patients actually achieved serum PSA reduction and you can appreciate that in these heavily pretreated patients in the late line, it is a very good signal of [ Ephicas ]. And as we expect, the steroid hormone levels decreased to unmeasurable levels in almost all patients. And then about our newcomer in our clinical pipeline, ODM-212, which is about to enter clinical phase, hopefully in the Autumn '23 this year. As I said, this is a molecule oral small molecule blocking TEAD activity and the targeted indications are solid tumors with YAP/TEAD activation. YAP/TEAD activation is seen in many solid cancer types. Particularly, activation is related to the mutations that are taking place in Hippo pathway. But perhaps most interestingly, this pathway is activated in patients whom drug-resistance develops. Drug-resistance to those drugs used in cancer treatments, EGFR inhibitor, BRAF inhibitor, MEK inhibitor, KRAS inhibitor. And the third role of YAP/TEAD activation is in the tumor micro environment, YAP/TEAD activation has been associated with resistance to immune checkpoint inhibitors due to upregulation of PD-L1. Very interesting molecule for us, and we, as said, we plan to be in the clinics and start first-in-man studies this year. ODM-111, our spearhead project in the clinical pipeline in many ways. For the pain treatment and also, of course, for the commercial opportunities that you can easily understand for this kind of molecule. Unmet clinical need for pain treatments is huge. Almost 20% of the adult population is considered to suffer from pain without a good treatment when it come to safety of pain medications and when it also comes to the improved efficacy. Orion's answer to these patients is ODM-111, which is a non-opioid, nonaddictive oral small molecule blocking NAV 1.8 ion channel. That has been shown to mediate pain signaling in preclinical models and also in the early clinical studies. Our Phase I study is ongoing. At the moment, we are now performing multiple ascending dose cohorts. And the results and data look so encouraging for us that we are now planning to enter Phase II studies and both in a good and chronic pain indications. And we aim to start those studies in '24. And as I said earlier, we have also several new molecules in our research pipeline that differentiate based on the mechanisms of action targeting various drivers of different pain phenotypes. Key takeaways as everybody understands very well, Nubeqa is the growth driver in short and midterm 4 innovative medicines and also for Orion as a group. We are focusing on oncology and pain, and I hope that you are also as confident that we are in the upper management team that we have done the right decision here about focus. Our pipeline is now more robust than earlier with 212 entering clinical Phase I and with many of our molecules proceeding to next phase is without any obvious issues. I think that with this, I can end and say that we have managed currently with our pipeline development, the best opportunities for the growth beyond Nubeqa. Thanks.

Tuukka Hirvonen

executive
#44

Thank you, Outi. Science is fascinating. Don't you think. I bet we will have questions later on, but now it's time to invite [ Hao Pan ] to the stadium. And actually, it's my pleasure to introduce Hao to the investment community. Hao has a long history in Orion. And he started as a member of the Orion Executive Management Board in the beginning of this year. So this is Hao's first time here, and it's my pleasure to introduce you. So please Hao it's time for you to take on the stage.

Unknown Executive

executive
#45

Yes. Thank you, Tuukka. Good afternoon. It's my pleasure to be here. I have been working for Orion for over 21 years, and this is my first time here. And hopefully, it's not the last time. Okay. So I'm responsible for the newly set up branded products division and we are very much set up to focus on Orion undeveloped legacy products to make sure we maximize its value. And these products have served Orion extremely well, and there are no strangers to you. But I just want to talk a little bit more today on them. As you can see that last year, the total net sales for Branded Products division was EUR 278 million. And this year, quarter 1 results of EUR 60 million net sales consists of 54% in Easyhaler sales and about just over 1/3 in entacapone products of Stalevo and contest content. And also, we have 8% in our HRT range and 2% from the others. And our geographical focus is very much in Europe, but also now in Asia and Pacific. And the 3 key product range here, so Easyhaler, entacapone, the [ Vina ] series, dictates our paying ground so-called in the therapy area of respiratory, Parkinson's disease and women's health. So in terms of the building blocks for growth. So how are we going to grow? It is actually quite on paper straightforward. Of course, a lot of hard work is needed. First of all, we need to make the most out of what we have. So we mentioned about Easyhaler. So I will talk a little bit more entacapone and also HRT range. And then we will use this portfolio to build on our strength of bringing in new products and new sales in the area of respiratory Parkinson's disease and maybe other CNS also and of course, women's health. How are we going to do that? We still have internal R&D. So that hopefully will generate some new products. And we have this new deal that we signed at the end of last year. And we're hoping that will bring some very fruitful collaborations to enable us to launch some new products. And we also are looking to in-license relevant products and portfolios. And of course, there is also this opportunity to take our existing and new products to new geographical countries and regions. So -- and also the M&A, which Jari and Liisa both have already touched upon. So then a few words about Parkinson's disease and Orion. You all know that entacapone products have already lost its pattern over 10 years ago, and last year, our total net sales was EUR 113 million, and that represents about 42% in comparison to the 2011 sales before patent expiry. So this 42% after 11 years is actually quite interesting to me because first voice shows entacapone is still very important to Orion as a company, but more importantly, entacapone products remain relevant, a very much cornerstone treatment options for Parkinson's disease patients. And you can also see here on the left bottom, there is a pie chart showing that Fermion, our API division is still producing about half of the total global entacapone APIs. And that again just shows we are in this game for the long run. So indeed, we are committed to remain in the field of Parkinson's disease, and we want to continue to make sure that our products are used correctly to the right patient, and we keep those awareness there amongst all stakeholders, but also, we really want to make sure that our supply chain is robust and we continue to supply to our patients with Parkinson's disease on our products in a smooth way. And what's more important, we want to maximize the heritage we have in Parkinson's disease and to really build for a future. And as we speak, very happy to say that Orion developed generic levodopa carbidopa product is in a launch phase currently in Europe. And hopefully, we'll take it to Asia Pacific and other regions through partners as well. And also, we have some other Parkinson's disease products with generic substances under development currently. And we are hoping to bring that to the market in the future as well. Then on to Easyhaler, and I'm hoping I can explain the reason why we are -- our current thinking behind this great portfolio for Orion. Easyhaler continues to be a fantastic story for us. You know this is our own developed and manufactured inhalation platform. And it is a simple and easy-to-use device but we actually have 6 different products in it, 4 of them are single molecules and 2 of them are combination products. And this is actually quite an important factor unique to this range of products, which I will touch upon. And we have already delivered over 1 million -- 100 million devices to patients worldwide. And we are very much committed to sustainability, sustainable life cycle management with this range of products. For example, our relatively low in comparison, relatively low CO2 emission per device stats has been further reduced. So during the last 3 years, it went down from 0.58 kilogram per device, CO2 emission down to 0.55 kilograms every little things really, really help here. So even though it doesn't look a lot, but it does show that we do care, and we want to do our best to continue to improve here. And talking about sustainability. Liisa already mentioned, this is the megatrend that nobody can really ignore. And indeed, it becomes more and more relevant to us. And recently, Health care systems are doing their bits as well. They are starting initiative to really set goes and to guide and to persuade or encourage clinicians to start thinking about sustainability especially in inhaler prescribing in terms of what type of inhalers you use. And there are country-specific differences here. For example, in the U.K., 70% of all inhalers are still in metered dose inhalers and only 30% or less than 30% is in dry power inhalers. So dry power inhaler is probably about -- so you talked about 18x more CO2 emission in a metered dose inhaler compared to a dry powder inhaler. So when you add them up, together, it is becoming quite a meaningful thing that we can all do something about. So here are 3 examples, and they are all quite recent. The first global initiative for asthma 2023 guidelines. This is the GINA guideline, but those of us who work in a field of asthma and COPD, we all know this is really a very important organization issuing guidance worldwide. And for the first time, they're actually saying -- and this is actually May, this month, early on this month, you should also -- you should choose the optimal inhaler based on the safest, best for patients, which we agree, of course, but also it needs to be for the planet. And that's actually a very strong message. And already back in autumn last year, 2 of the biggest European markets, U.K. and Germany for asthma and COPD. You have already got guidance, the NHS in the U.K., in England, specifically set this net 0 long-term plan. And in there, I have a quote here to say that they encourage that you should move from metered dose inhalers to more environmentally friendly dry powering inhalers. And then the German guidelines, which was issued climate conscious prescribing of inhalation medication. And here, we can see there is a graph here just to put it into context in terms of what it means, if you change a patient from MDI use to DPI, the whole year equation is roughly the same as switching to a vegetarian diet. And the reduction in CO2 emission is actually double, then you are not taking a flight for over 1,000 kilometers or you're driving 1,000 kilometer less. So that really shows that there is meaningful things that we could do there. So then what does this mean for Easyhaler. First of all, we think this provides the opportunity for Easyhaler growth. Because Easyhaler is a dry powder inhaler, and what's more interesting because I talked about the 6 products with Easyhaler, 4 of them are in single molecules. And in some countries, there aren't many options in terms of dry powder inhalers in the single molecule segments. For example, beclometasone in U.K., which is a large country, Easyhaler is the only available dry powder inhaler. So that just gives you some example of that. So we believe that naturally, there will be demand -- increasing demand. Actually, we are seeing that from the market when the sustainability Green initiative is being pushed top down. Also because we have this portfolio. So when a patient is using Easyhaler in a single molecule or when a doctor or a nurse prescribe Easyhaler, you get familiarity with regards to the device. And then if they need to use a combination or if they need to prescribe a combination product, then of course, there are chance for us as well in the combination market. So that's why we are quite confident to actually issue the new forecast of this EUR 200 million in annual sales. And the other thing, which, again, you probably know already, but I just want to say it here. Easyhaler, actually, the full range achieved carbon-neutral status since 2021, and that's something we are quite proud of. Of course, it's very exciting to talk about these things, but we need to do better or continue to do well in terms of the things to enable that. So internally, we need to take care of supply chain. We need to make sure our production is efficient and robust. And we also then need to anticipate all external factors. Of course, we talked about the green initiatives. So we probably don't have a lot of control over that, but we can certainly anticipate and adapt and trying to see what we can do. But also, we need to manage possible pricing pressures and also possible changes in regulations in certain markets and countries. And what's more important, we can do whatever we do with our existing portfolio, but the future won't be bright if we don't ensure that we have expansion in this portfolio through in-licensing and our own R&D. So the take-home message here, 3 very simple message here. First of all, we believe the green transition really create future growth opportunity for Easyhaler. And secondly, Orion remains a leading company in Parkinson's disease. And thirdly, our current portfolio is a good platform for us to build growth in respiratory Parkinson's disease, other CNS and also women's health. Thank you for your attention.

Tuukka Hirvonen

executive
#46

Thank you, Hao. It's very nice to see that when Noora in her presentation set the scene that you know ESG, it's not only about the reporting, but it actually can create business opportunities. And here, actually, we have a real concrete example of that, that it might create opportunities for companies. And luckily, we have now this opportunity ahead of us. So the next speaker will be Satu Ahomäki. She's representing the Generics and Consumer Health business division. So please, Satu, the stage is yours.

Satu Ahomäki

executive
#47

Thank you, Tuukka. And good afternoon, everybody. It's my great pleasure to talk about Generics and Consumer Health. My colleagues here have had wonderful presentations about innovative medicines and branded products. However, it's good to remember that when we think about the pharmaceutical industry globally, depending on the country, 70% to 90% of the drug volumes are created by the generic products. So all societies and the health care systems, they need generic products. Otherwise, they couldn't survive and not all the people can be treated with the innovative medicines. So just -- this is just as a [ pre-word ] disclaimer. And here, we have the overview of the generic business and consumer health in Orion. So our purpose is to create everybody and access to affordable quality medicines and also help individuals to promote the health with self-care medications. So last year was a very good year for this business segment, close to EUR 560 million. However, if you look at the figures from the first quarter of the year, you see there is a decline by 8%. And that is mainly due to 2 different factors. First is Russia. So we have had good sales in Russia, but this year, it has declined. And then the second reason is Simdax and Dexdor, they have faced even more generic competition and prices have eroded. And of course, in this business, pricing and the good service level, they are really the key success factors. 3 quarter of the sales are coming from the generics and then 25% from the consumer health. And majority of the sales, 56% coming from Finland followed by Scandinavia and Eastern Europe. So this business has been really a bedrock for Orion for many years. And when you look at the graph on the left-hand side, you can see that it has really shown a solid growth over the years. So earlier, it was, basically, it was called specialty products, so a little bit different product mix. But in essence, it's very much the same than this current business division. And there, you can see that the compound annual growth rate was more than 8%. So it was stronger than the market growth. In 2017, there was a quite significant change in the Finland in the pricing and system and the regulations changed. So there is this, we call it price tube. So it was decreased from EUR 1.5 to EUR 0.50, and it hit Orion since in the pharmacy every third drug package sold, it's Orion package. So that's why it hit us. So -- but after a couple of years, we have gone back to the growth path. And again, we are growing faster than the market. In Finland, we are in a very unique position. And when you look at from different dimensions, we tend to be #1 always. So in terms of how many employees we have, how what's we invest in R&D and also in -- when we think about our market share. So in the total human pharmaceutical sales, Orion market share is 11%, which is, of course, very, very high. And in the reference priced prescription drugs segment, it is 24%. And in Consumer Health, self-care product through the pharmacy channel, it is as high as 26%. So all that makes us very humble, of course. We are very grateful to all our customers, patients and consumers who are trusting our products, and it makes us just to try even harder because when you are #1, the rest of the pack is after you and they are running fast as well. So every day, we have to deserve our place again. So the current situation is that we are doing quite well. But still, there are some limitations for our growth. Over 50% of our sales are coming from Finland, and we know that number of people are not expanding here. So we have to create a business outside Finland as well. We are in the way, dependent of the external supply chains. They are the key role, and that's very typical for this business. Then we are developing generic products as well. But if we think about our current main home territories, which are Nordic countries and Eastern Europe, it's really you have to work hard to find a feasible business-wise feasible case to that quite restricted territory. And then we have 6 plants in Finland. And then, of course, to really take the full advantage out of that, we have to secure these volumes and volume growth also in the future. So what would be then the way forward? How to change this current situation, how to find the growth, and then you need to have this think bigger mindset. And it means that, of course, we want to cherish the current business. That's very, very important for us. But then on the other hand, we need to find the growth through new products and also from new territories. Inorganic growth has been -- and activity has been very important for years in this business. So I think that over the years, we have made hundreds of in-licensing deals and that activity will definitely continue. In addition to that, we will look maybe a broader portfolios and also company acquisitions to support this business and help to grow and also find those capabilities, which was mentioned also by Liisa earlier. And then we continue the development of these generics, but we have to go big. We have to go to these big markets in Europe as well to really gets the volumes. And of course, we can't compete with all Indian companies, the hyper generics. So we will focus on the complex generics. There are a little bit less competition, hopefully, and also to value-add products. And increasing value chain integration. So there are several things how you could do that. It's in the API, the finished products, the packaging. So usually, when you have a bigger hold of the value chain, you manage the whole value chain. So you usually are able to also in higher margins. Of course, it's not always like that. So there, you also have to quite carefully think about what are the right steps. But this is something what we are evaluating. So we are really in the process of thinking what would be the next steps here? And maybe that's the one sign about this focus. So now we are fully, we have people who are fully focusing on this business division only and what could fall that. So we have a huge portfolio. So over 2,000 SKUs. And in order to manage that better, we have divided it in 3 different segments. So we have this generic prescription products for hospital use. So there, of course, the hospitals, the hospital pharmacies are our key customers. There, the Simdax and Dexdor are really creating the foundation of that segments, added by the biosimilars, we have a long-term collaboration with Celltrion also made a couple of years ago a deal with the Curate biologicals. And then also new launches through in-licensing and from the Amneal collaboration. I will talk about it more in a bit. The second segment is the generics for retail use. And then the customers are pharmacies and outside Finland also pharmacy chains. So there, we very much rely on the current home markets, so in Nordics and Eastern Europe, which has been the bedrock for this segment. But then also, we are planning new launches then outside those territories, and look growth from there. And last but not least, is the consumer health. As I already told you, we are very strong in Finland, but consumer health is a very attractive market, pre-pricing, for instance. So it really encourages you to think about how to develop your portfolio and also territorial expansion. So this is, again, an example of what we are currently examining. I promised to talk to you about Amneal collaboration. So this is something what we published in January. The strategic partnership with Amneal and it's -- Amneal is a U.S. company, a fully integrated pharma company. And they have in the diverse portfolio, 250 generic products and also a strong pipeline. And with this exclusive license deal, Orion has right to develop and commercialize Amneal products in Europe, Australia and New Zealand. And of course, I'm not saying that we are going to launch all those hundreds and products in Europe as well. Since it's good to understand that the markets are a bit different in the U.S. compared to the Europe. First of all, the price levels, they are higher in the U.S. than in the Europe. So therefore, there might be that it's not business-wise feasible to launch some of the products in Europe, which are already on the market in the U.S. And then also the regulatory pathway, there might be differences, so we need to do -- might need to do something extra for Europe. So -- but we go through one by one, though, all those products and those -- what is in the pipeline, and then we make these decisions. And I'm happy to say that we have already started that job and couple of decisions we have made already and the launches are then expected in coming years. Very excited about this collaboration. So as -- it has been said that this business division is bedrock for Orion and it's supporting the Orion growth, it's supporting the other businesses as well, in order to maintain that position and be in that role also in the future, so we need to grow, and we have to really go forward. And this is a very dynamic business, of course. And therefore, the continuous renewal, it's a must. And we need to manage the portfolio also very well. And it's a type of business where the portfolio, it's -- there are things which we have to terminate stop selling because of the profitability reasons or then there are other things, there are products coming into the portfolio. So what we need is a vigorous product flow through our own development, through in-licensing, various alternatives, as I discussed. Then also, we need to improve our competitiveness. So as I said earlier, we are not in that hyper generic deep, cheap market. So we try to look for opportunities where a bit less competition. So something that where we could really add value and where we could meet the requirements for the competitiveness. Territorial expansion. So we are #1 in Finland, among top 10 companies in Scandinavia. Also in Poland, we have been many years, the fastest-growing generic company. But as said, it's really not enough if you want to go to the next level. So we need to conquer this big European markets. So those are really the building blocks for the growth. So I'm actually ending my presentation with this slide, and I have 3 things, which I hope that you will remember. I will hope that you remember that we have a very unique position in Finland. Secondly, the geographic expansion that is something what is needed for the growth, and we will focus on the complex generics and value-add products. Thank you.

Tuukka Hirvonen

executive
#48

Thank you, Satu, for the update from Generics and Consumer Health. We still have one to go. I hope you bear with us, still one more presentation. It's my pleasure to invite to the podium also a newcomer to the Orion executive management board. However, you have met Niclas already earlier in these events, but now he's here for the first time as the Senior Vice President. So Niclas, in your new role, please?

Niclas Lindstedt

executive
#49

Thank you. Yes, I was actually thinking that maybe I should stop here -- or start where the other ones stopped. And basically, when I were listening into Satu she was saying, we need to go wide and we need to do that. And where I actually come from now is, in my previous job, I was responsible pretty much for sales, marketing and business development in the Animal Health division. Today, we're actually a business with a production site, the logistics side, and now actually from mid-May also our own R&D operations. So clearly, it's a new opportunity for all of us. Going forward, what can we get and what can we achieve with what facilities and the opportunities that Orion has given to Animal Health. But just before we go there, I think that one thing you have to put into context is if we look 10 years back when we look during the history of animal health, what's happening is really the consolidation of the market. It's consolidated both from a customer point of view. The veterinarian change, the integrators in poultry, all these companies are becoming bigger. On the other hand, also the pharma companies have gone together. So over the years, when we started or when I started 10 years ago in Animal Health, we had really big companies, and we used to be a small -- big fish in a small pond. Because we were in Scandinavia, we were representing the big boys in Scandinavia and in the Nordics. But now what happens is, of course, that the world is getting smaller. And when the consolidation has gone that far that the big companies almost cover 70 -- more than 70% of the market. You either have to step up and go outside your own comfort zone. And that's what really what happened last year with the acquisition of Innovet. What we really did was we actually bought widening the scope for the business, but also deepening it. In a sense that earlier we were talking about companion animals, where we were talking about how the dog trend was. The COVID was very good for us. Everybody got a dog. We came into that. Now of course, it's all about also keeping in mind that protein is really important for many places in the world. And of course, we all eat and need that. And then the question is how can we actually capitalize on that opportunity going forward as well? So when we actually went into the acquisition with Innovet, we knew there was no overlaps because as I said, it's getting wider but with portfolio, but also deeper in the sense that there's markets where we haven't been before. And these things when we start taking into consideration, the challenge for us is, of course, how can you make it work from day 1. So of course, what we have done since the acquisition is really trying to integrate, build and combine the different opportunities in the 2 companies. As you can see, really, by doing that step change, we also got to a position where you think if you look at the animal health market globally, we're now among the top 20 companies in the world, which also gives us opportunities for more in-licensing opportunities to expand outside where we are today. If we then look further down the road, what really happened? I mean, when we used to be a small fish in a -- sorry, a big fish in a small pond, focusing on the Nordics and out-licensing outside, we were really focused on new innovations. I mean the only thing we wanted to do was find unique products, license them out and get something in return for our local markets. Now of course, with our businesses is much more wider foundation. I mean, we're only -- not only focusing on new innovations. We have generic developments. We have collaborations in ProHealth, which is non-pharmaceutical products. We do a lot of in-license still, and we also have launched some services globally. And this is the foundation where we're now building the new R&D. Of course, we still do a lot of export to some markets where we're not are. And we also out-licensed products for certain markets where we have lesser presence. But clearly, our focus is becoming more and more to be the owner of the value chain. And that's why, for example, now when we look at where we're focusing on over the next 6 months is really getting certain products which we have from our pipeline into the markets where Innovet is present, and we were not present earlier. Of course, then everybody asks me, so how can you say you were an innovative animal health company. And of course, the best way of showing that is really to show some kind of a track record. And clearly, for us, if we think about everybody who knows R&D and development. And we have had these discussions over the years that what -- how much did we benefit from the human R&D? A lot. And today, of course, it's an opportunity for us to take that benefits and those information and experience we received over the years and build our own future. And if you look at some of those products now, for example, in 2021 [indiscernible], new indications, new products into a totally new segment of behavior. Now expecting also to enter the U.S. market and also having an opportunity to go forward from there. What I'm saying is that we really utilized all the benefits from being a part of the big global R&D over the years. Now we're really putting our foot down and saying, we are looking at making this on our own. On the other hand, also from earlier, we've really been benefiting from the production and utilization of all the services inside of Orion. Now we're looking at how can we actually utilize that in an animal health company for the future. We really -- our key message today is really to try to make the most of the combination of Orion and Innovet together. The thing here is we really have sort of opportunities. We have a functional company. But of course, we have a lot of corporate knowledge and processes which we're going to drive in there and, of course, make sure that the compliance, the world, everything is met to the highest standard and going forward for there. So that's really one of our key elements is now to have the foundation to build a really global animal health company. Of course, we focus on in-licensing still. Now we have a larger target. We're not only working in the Nordic area. We're also working in Central Europe, also in Central Eastern Europe. Where going forward, we do some experts outside to Asia and to Africa, Latin America and the U.S. So really from that point of view, and also when I was listening to Satu a while ago and when she said she had most of the people of Orion generics in Finland, I was thinking that, well, actually for anymore health, most of our people are actually in France and Belgium, we are actually sort of a really small part in Finland. So we're becoming more and more European which is actually giving us the opportunity now to go into the bigger markets and work with our partners, but also on our own. So that's clearly one of our opportunities going forward. Then of course, there's a discussion on livestock. Where do we focus? We focus really much on poultry. And that is also a very consolidated market around the world. So of course, that needs that you have to be able to compete. But also at the same time, you have to be available in all the markets where they would like to have your products. And I think that sort of gives us also an opportunity now with a bigger organization and a bigger footprint to actually push that forward. Then when it comes to opening up a geographic expansion, I believe the first thing what you need to do after you swallow something is you have to chew and then you have to -- sorry, after you bite off something you have to chew and then you can swallow it and then you can move forward. But I think that, of course, there's 2 ways of growing a business. It's more products or more markets. And clearly, those 2 are we now expressing from both ways. I'm very glad from the slide, even though I admit that we were 9% of the turnover last year, but that Orion is still committed to give us the opportunities and win to actually under our wings to build that forward. Then of course, when we're looking at -- Okay. Sorry. So when we focus on what's really -- how do we make it the most out of Orion and Innovet, and the step change? I mean, really, for us, the most important thing is the customers. And of course, when I said we're going -- we're becoming deep, it's also that we have very different customers. So of course, we have to focus on the veterinarians, the pet owners, but also on the farmers and the integrators and the change, the buying groups and so on. So the good thing about that is we now have the opportunity and the means to talk to people because earlier, maybe we did not only have because we were really specialized in a segment especially in -- when you think about Orion's old markets, we're around 6% of the global market, which was the Nordics and the Eastern Europe. Now of course, with the new opportunity, we are actually dealing on the global market. Which gives us opportunities again to build, to invest to grow. Of course, what we're also looking at the moment is clearly on the cross-selling. I mean we're taking our products down to Belgium to France, to the near areas, looking at U.K., seeing what we can do where. And that's, of course, the easy ones to do first. At the same time, in an integration, you also know that the most important decision is not what you're going to do is what you're not going to do. So you have to make sure that you don't spread your efforts to thin. So you really focus on the areas where you can make a difference. And that's what we're trying to do now is really to find those winning concepts to go forward. And of course, I mean, we have a new own production unit, which is really dedicated to animal health. We're working with the Orion production to make sure that all the standards are met and everything is in the way. But clearly, that's an opportunity to us also to deliver products around the world. And of course, the geographic expansion again. But -- so that is really the key. But also when we go to the R&D focus, which is interesting because I used to say in the past that I used to have the biggest R&D from my size of company because I had 500 people in R&D because we use the human ones. But of course, now what I say is that we have a dedicated team really working on R&D, which is going to give us the real -- to focus on what we need going forward because that's -- we know now that [ imeds ] are really going to focus on the new molecules. We know the generics are looking and the brand they are looking for their own, but now we have an opportunity to have a dedicated new product opportunity. And as it's not been customary to disclose these opportunities. I still -- not going to do it unless I'm getting asked in the future. But the only thing I can say that for once, there is a lot more opportunities than threats. So shortly, I mean, we're here, we're going forward. The Inovet acquisition is ongoing with the integration. We're working our best to actually get it as soon as possible. On the second thing, the larger exposure to the global world is also giving us an opportunity with a wider portfolio. And we're really focusing and doubling down on the R&D efforts and in-licensing to actually get to the next level. Thank you or any questions? I can leave enough time for questions now, so...

Tuukka Hirvonen

executive
#50

Thank you, Niclas. Actually, if I may add something to your presentation is that actually Animal Health is now pioneering the M&A front within Orion Group. And of course, as you are learning, the whole group is learning, should there be any future M&A. So you are actually teaching the rest of the gang, so.

Niclas Lindstedt

executive
#51

Yes, well it's a new experience for all of us, even though I'm a long-time Orionee. So I never really gone through a similar one inside of Orion. Outside, yes. But -- so clearly, this is something where we -- I think -- well, this is one of those where you ask me tomorrow or ask me today after that if people are happy, so...

Tuukka Hirvonen

executive
#52

Thanks, Niclas. And before I invite all the other presenters to the podium one observation to make. All of our business division leaders used less time than was dedicated to them. So I think our management team is fairly efficient also in this way. But now this means that we will have more time for questions. I'd like to invite all the presenters back to the podium, so that we can address any questions audience may have. I have some incoming from the webcast line, but let's first give the floor to the people here in Helsinki. So shall we now start with Sami because Harry was first in the first session. So Sami, please, we are ready to take your questions.

Sami Sarkamies

analyst
#53

Okay. Sami Sarkamies, Danske Bank. Starting from Outi, I have 2 questions. You had a slide where ODM-208 was the only program featured as part of both medium and long-term sort of growth prospects. Why is that? I mean, why are you treating it differently to the other programs?

Outi Vaarala

executive
#54

Well, the reason for that was that actually ODM-212 was included in the research projects that were under 208. So it's, of course, part of the long-term growth factors. But ODM-208 it can give the growth for us in midterm around -- beyond '25, and it brings because of the patent life also -- life also a growth for us longer. But 212 should be also there as well as other products that are coming from our research pipeline. We still have, of course, significant sales when it comes to Nubeqa and so on, but the additional growth is by these products.

Tuukka Hirvonen

executive
#55

And if I may, Outi, add here that actually also the other programs are included in the longer term. But to be honest, there was too little space for all of that. So actually, that's also a sign of our more robust R&D pipeline currently, but good question. Thanks.

Outi Vaarala

executive
#56

[ Despite additional ] growth drivers.

Sami Sarkamies

analyst
#57

Okay. Continuing with Outi, could you give us a few examples on target indications for ODM-212?

Outi Vaarala

executive
#58

Examples of target indication for ODM-212, when we talk about this acquired drug resistance and you saw the treatments that are mentioned there, like EGFR inhibitor and so on. Of course, we -- and the scientists around this pathway are thinking about lung cancer options where we use these kind of treatments that are associated with the drug resistant development via TEAD activation. That's about it.

Sami Sarkamies

analyst
#59

Okay. And then finally, I don't think you said much about ODM-105, how would you describe the project and the sort of human opportunity for Orion?

Outi Vaarala

executive
#60

We are ready with Phase I, as you know, and we are now planning our Phase II. For ODM-105, as you can imagine, there are several indications to be considered. And we want to announce the indication to start with a little bit later.

Harry Thomas Sephton

analyst
#61

Brilliant. Harry Sephton from Credit Suisse. My first question is on oncology, where you have quite a strong track record in small molecule drugs to treat hormone therapy. But as you mentioned in your slides, you're looking at areas that are focused on novel biologics and cell and gene therapies. I wanted to get your sense on where do you think your science is differentiated in these areas that can make you competitive in that area of oncology?

Outi Vaarala

executive
#62

When it comes to biologics and antibodies, we can differentiate, for example, with bispecific antibodies when we have a novel target pairs there. And -- we have in our research pipeline, projects. I hope that I can talk very soon about them and reveal the target pairs, but that's the differentiation we are talking about, in a way, first-in-class ideas.

Harry Thomas Sephton

analyst
#63

Brilliant. And then my second question was on ODM-111. Can you maybe give a bit more detail on the clinical development of that asset, maybe the size of studies required, the length of the study required by regulators, especially with regards to the non-addictive claims potentially of that asset. And you mentioned the phenotype of pain being very important. To that point, how broad will you plan to study that asset if you bring it to Phase III?

Outi Vaarala

executive
#64

Now I need the disclaimer slide again. So -- but I can base my views now or actually on the published literature. So now 1.8 blocker in preclinical studies and in the early clinical studies done by Vertex. They may have actually efficacy in acute pain and in chronic pain indications, indications such as neuropathic pain and osteoarthritis. So that's the evidence we have at the moment. And of course, we follow science. We follow that evidence. And then you can guess what are the indications that we are aiming. When thinking about the length of the study, Phase II study for acute pain, is a short one. Phase II studies may take a little more than 1 year or 1 year. If we are successful, we may have a possibility to start Phase III studies in 2 years' time. And of course, in this kind of environment where we are now, when we are talking about Inflation Reduction Act happening in the U.S. And so it's important to do a very aggressive and broad clinical development plan. And I was referring to that when I said that we needed to do focusing on pain because we want to resource fully this program, we want to. It's not about us if this program fails. We put our all resources to be successful.

Harry Thomas Sephton

analyst
#65

Brilliant. And my final question is just on the new Easyhaler target. So the EUR 200 million or greater than EUR 200 million sales over time. Can you maybe just give an indication as to what the contributors to that target? I know that budesonide-formoterol has really been the key driver of growth for the Easyhaler franchise over the last few years? Is it still very much that asset, which drives you from where you are to that EUR 200 million target? And maybe then to just include within that question, the, I guess, the significant eco benefits of moving from the metered-dose inhaler to the dry powder inhaler, what proportion approximately in the markets in which you compete are in metered-dose inhalers versus dry powder inhalers currently if you have that to hand.

Hao Pan

executive
#66

Yes. So in terms of -- from my presentation, you can see that the -- when I was describing about this new EUR 200 million, I keep talking about our portfolio. So we have 6 great products. So I would say that without going into too much details that we are hoping that the growth will have a contribution from our entire portfolio. And in terms of the competition, I also, again, give an example in the single molecule side, then there aren't too many dry powders inhalers available. And a lot of devices, for instance, U.K. and then Germany, still over 90% of the devices in single molecules are still in metered-dose inhalers. So the market is quite large. So that probably is somewhere that we can see some improvement on what we can do. And also, of course, with dry powder inhalers in the combination market, the dry powder market -- inhalers are more dominant or more equal in terms of where they were. And there are country-specific differences. So it's quite a complex picture trying to answer that question, but we're trying to monitor and adjust what we do country by country, molecule by molecule, trying to get the best out of everything.

Tuukka Hirvonen

executive
#67

All right. Do we have any other questions currently from the audience? Sami, you have a follow-up?

Sami Sarkamies

analyst
#68

Yes, I have 2 questions for how -- I think you've been scaling back investments into Easyhaler during the last couple of years. Will you need to step up? Or is it so that you will be able to reach this goal with existing products only?

Hao Pan

executive
#69

For me, because I'm coming from -- my background of working with the region -- from the regional side, I wouldn't say that we have been scaling back in terms of the investment from the customer engaging front. Of course, you can see from Outi's slide that from the R&D side, of course, we stopped. But I would say in terms of engaging with stakeholders, we actually have gradually building up our presence and trying to compete with the big guys in an innovative way and in a targeted but effective way. So again, without trying to giving you a sum, but this is where we strive to do better in the future.

Sami Sarkamies

analyst
#70

Okay. And then second question. I think today, you also revealed that you have plans to build a generic Parkinson's franchise, at least in Europe. How material contribution to sales could you see from this, let's say, in 5 years out if you're successful?

Hao Pan

executive
#71

Yes. Again, we don't give projections like subproducts or subgroups. And we all know the fact that we talked about the word generic here with generic substance, we are not expecting high premium in these products that we bring to the market. We're very much focusing on the patients, the need of -- the necessity of having a variety of these products. So that's what we focus on. By doing so, of course, we believe it will contribute towards our overall growth.

Sami Sarkamies

analyst
#72

Okay. So just to be clear, you're trying to grow sales from current level. So it seems like a defensive move only.

Liisa Hurme

executive
#73

It's really as how very well described to fulfill the portfolio to be able to serve the neurologists and patients in a better way, of course, at the same time, growing the revenues being generic molecules that we are combining. It's not possible to get a great premium price in the European market, but of course, significant sales to grow the branded product portfolio.

Tuukka Hirvonen

executive
#74

Any further questions here in Helsinki? If not, I still have a couple of more coming from the webcast. Actually, we can start with Outi and ODM-212, actually Graham Parry asked the same question as Harry that what might be the -- or was it a Sami? Sorry, can't remember. What would be the initial target indications? But you already mentioned that lung cancer as an example, one possible indication for that -- but first we need to tackle the Phase I hurdle and then we will move forward a little more.

Outi Vaarala

executive
#75

I can add also here that there is also obvious efficacy that is seen in mesothelioma where hippo pathway mutations are seen in most of the patients. But it's a rare oncology indication. And we are, in a way, considering that perhaps as a business case, it would not be the most attractive for us. And again, thinking about the environment, Inflation Reduction Act and so on. So that's an important indication, but we need to do wise decisions about indications that are really important for the patients and commercially available for us.

Tuukka Hirvonen

executive
#76

Then we can still continue with ODM-212. Viktor Sundberg from Nordea has a couple of questions. So he brings up that so many previous molecules targeting this pathway has had trouble with not being specific enough causing off-target or side effects. Can you just briefly mention how you have overcome the challenge with your TEAD inhibitor? And the second question is that in addition data from competing molecule BT3989, was presented just recently in AACR, any comment on that data and on the differences between ODM-212 and that molecule. And before I let you answer, as far as I'm concerned about that, actually, we will only see in Phase I the kind of possible side effects. You cannot see everything in the lab before, right?

Outi Vaarala

executive
#77

That's true.

Tuukka Hirvonen

executive
#78

And it comes to the other question. So basically, -- it's not appropriate for us to comment on competitors' data. And then, again, we don't yet have clinical data on ODM-212. So kind of the comparison also with the competing molecule at this stage is not kind of feasible.

Outi Vaarala

executive
#79

Yes. I can add to that, that yes, it's true that many companies have struggled with this pathway and with the TEAD inhibitors. And we have now a compound in our hands that we believe that is good enough and reliable enough to be tested in the clinics in humans. And we are encouraged by the data from BT molecule from our competitor because they were able to do a Phase I study without any issues when it comes to -- severe issues, I mean, when it comes to off-target events or on-target side effects. So we consider that data actually encouraging for us. And as you all know, in oncology, we can tolerate more side effects than in other indications like, for example, in pain. And as Tuukka said, the only way to see whether our molecule can differentiate is that we go to the clinics and test our molecule in the clinic. So that's what we are doing at the moment. I would like to say that when you think about darolutamide and ODM-208, I can say that we have golden core of Orion R&D in our chemistry.

Tuukka Hirvonen

executive
#80

All right. That's a good answer. Thank you, Outi. We have no further questions from the online. We still have here a follow-up from Harry. All of you following the webcast now is your last chance to type in questions if you have any, otherwise, we will need to end early in time. But now let's give the floor to Harry.

Harry Thomas Sephton

analyst
#81

Brilliant. I'll ask one on Animal Health, please. So you mentioned a lot about geographic expansion and the U.S. market. So clearly, that's the largest market for Animal Health and where you can probably achieve the highest margins. I wanted to get your sense on what's your strategy for going into that market? How easy is it to commercialize in the U.S. yourselves? Or is out-licensing maybe a preferable option for that?

Niclas Lindstedt

executive
#82

At this stage, out-licensing is clearly preferred. I mean we've been working with partners in the U.S. for the past 25 years. We've been very satisfied and the collaboration has worked very well. And I think that's really been the cornerstone. And now we have actually 2 different companies we're working with, and we feel that at this stage, this is really the way forward. I agree with you when it comes to the U.S. market, when it comes to the generic -- how much penetration they actually achieve and the whole pricing system, I mean, so much I followed it and saying, unless you have something unique and totally specific, you have an opportunity to go there. But then at that time also, you have an opportunity to use the partners or the collaborators you work with. So -- but no, at this stage, U.S. is actually not in the target. There's plenty of room outside.

Harry Thomas Sephton

analyst
#83

Brilliant. And I also had a question on generics. So clearly, the capabilities of [indiscernible] manufacturers have increased over time. And so whilst you probably point to an increased focus on more complex generic manufacturing, which I think has been a target for a lot of generic manufacturers for many years. Can you maybe give some examples of where Orion can differentiate versus some of the lower-cost manufacturers and how that might be able to stem this ever-declining margin that we've seen in generics over the last few years?

Satu Ahomäki

executive
#84

Yes. Thank you for the question. So I think that it's -- I can't say that all the complex generics is something what we could aim for. So we -- again, we need to handpick those where we see that we could be cost competitive. With the complex generics, it could be something that going with the -- from big tablets to oral solutions, for instance, or to prefilled syringes or somehow improving the current -- sorry, current products to offer something more for the customers. But -- yes, I don't want to give any exact examples, but that would be the way to go.

Tuukka Hirvonen

executive
#85

Sami has another one, and then we will also have follow-ups coming from the webcast, but let's first take a question from Sami.

Sami Sarkamies

analyst
#86

Yes. Okay. So this is a general question to maybe Liisa and Outi. When we think about the plans to scale up R&D organization, what is going to be limiting this? I mean you obviously need to find talent. You will probably have the money, but we've been quite cautious with R&D investments. So what is sort of realistic scale-up plan for the Orion internal R&D?

Liisa Hurme

executive
#87

Well, maybe I start. Well, I think we've been rather stable with our internal R&D. To date, I think we've been able to be [ lucrative ] employee, and we have recruited a lot of very high-level expertise and experts, abroad to Finland. And you already mentioned where we are, really excellent. But when I look at it on a broader perspective, the whole innovative-medicines perspective and where should we really accelerate and build, I think it's clearly on a commercial, on a market access, a medical-affairs side, it's a very different thing to develop by yourself and start to plan the commercialization by ourselves. We have relied a lot to our partners this far. And Outi you may continue on more on R&D.

Outi Vaarala

executive
#88

I -- of course, I agree with is that that's the next step in a way in the development of our R&D, medical-affairs market access and then in the future also in our business, commercial operations needs to be developed so that it fits well with our Innovative Medicines. When it comes to the limitations, there are -- we have had when it comes to developing our discovery skills, we have been successful in the recruitment to Finland. But it's something that we are discussing all the time, how we will do the development of these areas in the future. We don't have the answer ready to you, but we are working, of course, hard with that because we don't want to fail because we are late with our investments to these kind of activities and renewal of our R&D.

Sami Sarkamies

analyst
#89

And if we think about the size of R&D activity relative to sales, it's currently at about 10% level. It's been there sort of fairly stable over time. Do you think you will be able to maintain this level also going forward? Or is that going to be difficult?

Liisa Hurme

executive
#90

I think that's a key question really when we discuss the capital allocation and how we build the future. Of course, we will invest more to R&D. That's my personal very subjective view, and that's how we are all prepared to go forward. The revenues that we receive from Nubeqa build a very, very good platform to invest more. And if we look at the percentage, it's actually 40% as Outi presented on the Innovative Medicines side. If you would think it's a company only selling Innovative Medicines, it's actually a rather high percentage. But even on a cooperation level, I expect that to slightly increase during the coming years.

Tuukka Hirvonen

executive
#91

All right. Then we have questions coming from Iiris just a moment.

Iiris Kemppainen

analyst
#92

Iiris Theman from Carnegie. Just on generic price pressure in your large market, Finland. What is the current situation? Are you facing more or less price pressure? And do you expect any changes in regulation in the short or medium term?

Satu Ahomäki

executive
#93

Well, I think Liisa already referred to that in your opening words. So yes, the price pressure is something which is always present in this business. And also in Finland, the average price of the generic prescription products is going down all the time. And we foresee that, that will continue also. There are lots of discussion about the -- if there will be changes in the pharmacy systems in Finland and what will be the implication. So it's too early to say. We don't even have the new government yet. And of course, I believe that Orion having such a strong position in Finland. So we will then always find our way forward, and we can always be competitive in that market.

Tuukka Hirvonen

executive
#94

All right, thank you. If no more questions here at the venue then going to webcast and Jari, you will also have one question. So this is coming straight to you from Graham from London. Sorry, Graham, I missed your question earlier, but here goes. So Jari, you seem to suggest operating margins may fluctuate around the 25% level, may not be above 25% every year. Is this the right way to think about mid- to long-term margins i.e., limited upside beyond 25%? And what is the expected shape of the progression? Again, i.e., are the dips under 25% more near term with above 25% more of a midterm target?

Jari Karlson

executive
#95

Well, of course, we are not giving this exact year-on-year guidance. So it's very much linked to what will happen, especially in the [ imeds ] area that how do the R&D programs proceed. As we all know, of course, Phase IIIs are the expensive part and you first need to get there and then come to these decisions about the commercialization, how much are we going to spend money there on our own or how much we are partnering and so forth. And if we take a robust look in our sales, the more we do our sales, then of course, the short-term impact is negative on our profitability, so it will decrease. But it's a little bit too early to say about that for example, ODM-111, which is one of the obvious candidates for this kind of development is only in Phase I for the time being. So we still need a lot of more data before those final decisions can be made. But I think that's clear that if we go forward with this expansion of our own operation, that will, in midterm, decrease the profitability to some extent. But of course, it also depends on how well Nubeqa is doing because lots of the growth on the other hand, is coming from there. So the more it come from there, the more we, of course, have money to invest without decreasing the profitability. So there are lots of variables, which we, of course, need to take into account all the time when we then make the shorter-term planning.

Tuukka Hirvonen

executive
#96

All right. Thank you, Jari. There are no more questions online. How about here in the audience? If not, I will thank you all for the presentations and invite Liisa once more to the podium to give her final remarks for today.

Liisa Hurme

executive
#97

Thank you. First of all, I want to thank you for your attention. It's been many hours of constant talks. It's been great to see how you focus and hear your questions. And just to summarize, growth driver, Innovative Medicines in a big scale. Then we have the solid bedrocks. Of course, all of those will grow as well. And the biggest of those is generics and consumer health. You saw already in the beginning how big role that business division has. And sometimes we are asked even today that whether we have to diversify then we have so many business divisions. But imagine if at the time of Stalevo generalization, we wouldn't have had the specialty products and generics. So I see that it's extremely important to keep a very balanced business. portfolio. And of course, for the growth in each of the areas, R&D, in-licensing, geographic expansion, there might be actually synergies and strong synergies even with the geographic expansion. Synergies exist in R&D, even though Animal Health will be establishing own R&D, they will have access on Orion's innovative molecules. And mergers and acquisitions, they are a tool to build capabilities or expand into new geographies or grow our portfolio. I hope that we have been able to create and bring you some granularity in our businesses and how we go forward. And also some hints on -- there was a question that how do we view our strategy? Is there something new, but I think -- I hope that we have been today been able to convey a message on that as well that there are some of our old products, so to say, we still have a lot of potential to grasp. We have extremely good strong pipeline to the company size of Orion and validated, and we have businesses that are supporting the growth. Thank you for your attention.

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