Very good afternoon, everyone. 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. 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 two Q&A sessions, and one 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 Finnish time.
Within the Q&A sessions, we, of course, first like to address questions here from the live audience. I have two colleagues here in the venue with microphones. Please, before you ask your questions, wait for the microphone so that also the webcast viewers can hear what you have on your mind. Of course, dear 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 the Q&A sessions, we 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 us. 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. Of course, like always, the actual outcome then might differ substantially from those stated here today. However, we then receive 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, you know, just as a reminder that this typical safe harbor statement about the forward-looking statements. I guess that would be all from my side in the beginning.
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.
Thank you, Tuukka. Good afternoon on my behalf as well, you are warmly welcome to this Orion Capital Markets Day. 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. The usual disclaimer, as Tuukka already went through that, I'm not going to discuss that more. Let's see how this works. For those of you who have not met me, I think I've met many of you even during this first six 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, 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. 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. 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. For the last four years, I led our operations, which is all our manufacturing sites, both API, drug products, procurement, industrialization, and whatever has to do with operations.
Now, after six 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 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 welcomed questions to a new president and CEO, and comments, and I received more than 1,000. I think that's already a sign of a commitment that people really want to share what they think about the company. There you could see how committed they are. Also, I got many good advice. 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, about 30 years or something.
Now we have new partners like MSD and Bayer, during the 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.
When we look at how we've actually survived these 10 years, which started with Stalevo losing its patent protection in early 2010s, 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% as a compounded average growth, you can see that we've created more than EUR 350 million of growth during that time, compared with the EUR 165 million of lost of sales due to the patent expiries. 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 three major products, there is a lot of things ongoing all the time when you need to create a new growth. 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.
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 two notions that you got to make. One is actually in line with what I earlier mentioned, that we've done well. We are a Finnish Nordic company, mid-size 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.
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. We are all the time evaluating when would it be the right time? What would be the right products, 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. What is typical are the mega trends.
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 mega trend 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. 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. Now I'm not talking about really the requirements of ESG, which are in the regulatory corner here, but really sustainability in a way that how can a company make this into a competitive edge? 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. The global supply chains. I think the pandemic showed us that that's a tricky thing, you know. The company that can really master these global supply chains is a winner.
This is especially true for the generic industry and for the API. 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, we will hear more about that, Noora Paronen will talk about how Orion approaches this, also from the other perspective that I already mentioned, from a more broader concept of sustainability. Compliance, 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, that's something that all of us will need to, of course, do in a very diligent way. What comes with the aging population, healthcare cost, pandemic, is a pricing pressure. We see every year that drug prices in Finland, they decrease and decline approximately 10%, that's clear. That's the environment where we are. 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 see 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. 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?" 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. We stick to our current strategic targets. We want to grow faster than the market, which we've actually done, or we've carried, or grown according to the global market growth, and then grown faster in certain geographies or segments. We want to develop the sustainability, and of course, when we grow, it has to be done in a profitable way.
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. We have innovative drugs. After many years, we have Nubeqa, we have something very different, like generics and consumer health. For the innovative medicines that Outi Vaarala will share with you, Nubeqa is the main product.
What we wanted to really do is to combine the business and research and development, ’cause 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. For the branded products, there we have our so-called legacy brands, like Easyhalers, Stalevo, Divina product family for hormone replacement therapy. We have longstanding relationship with our neurologists across Europe, with pulmonologists, and in some countries, still with gynecologists. 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.
To Branded Products, the regions that report to 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. 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. All these now will have an ability to grow according to their needs and also compete with their peers as they should. It's not only the marketplace, but will also change the ways we work within the 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. 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. Whenever you look at our sales reports 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.
Animal Health, after the acquisition of Inovet, there are two 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, how would you call it? You are partner to their businesses, and Niclas Lindstedt will talk more about that later on. 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 we will hear later on today. On long term, our new molecules, ODM-208, ODM-105, and ODM-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'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?
Yes, I will take it for you.
Good.
Thank you, Liisa, for the opening remarks and setting the scene for the rest of the gang. Next on stage will be our CFO, Jari Karlson. He will share his thoughts on capital allocation. 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. Now, Jari, please.
Welcome from my part as well, and good afternoon. 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. 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 remain the same. 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.
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. Growth without profits, without capabilities to pay dividends, doesn't really help us. Of course, the importance of the goals might change over the time when the business environment changes. There are couple of kind of background and basic ideas when discussing these topics. 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 a long-term thinking. Also, the R&D, especially the R&D part in this industry, is very long term.
Also, the ultimately, the way to create value is probably the long-term profitable growth. 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? Also, on the other hand, how well can we communicate and tell to the outside world so that this picture about our investment is credible to the outside markets?
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 makes sense. 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 two 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 growth that already has taken place.
You are pretty much giving out the money you already have earned and create value that way. 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. Of course, it's a fact that there are also companies who really are very much on one of these extremes of this picture as well.
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 so important and why are we talking about that? Actually, this same topic was discussed already couple of years ago in the previous CMD, and at that time, there was no inflation. 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 true at that time as it has been now over the last one year or so.
Of course, larger scale of operations means that you can easier carry the, in this industry, especially quite high fixed cost base that is needed to stay in the industry. It means that you have more resources to develop your business, and you can take more risks. Finally, last, but definitely not least, we all know how much there's, in today's world, fight of good people. 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, needs to be able to provide them good opportunities. Without growth, that is definitely much, much more challenging. Growth is also needed to create the basis for all of these other things.
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 rate used in the valuations, which impact the 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. Even small changes in the views of what happens in the future can actually have a quite a major impact on your, on your valuations.
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. As one can see, when time scale is long enough, they tend to be fairly close to each other. Also in these slides, one can see that dividends have had a big important role over the history of Orion's shareholder value creation as well.
Capital allocation and value creation in Orion, what has historically been the case? 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 the dividends, that number would have been a couple of percentage points higher. Fairly decent return. Our P/E 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.
As a combination of these two earlier points, we currently are actually in a situation that even though our payout ratio is quite high, our dividend yield actually is not anymore 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 yields than Orion. Moving maybe a little bit more closer to what we are thinking in Orion. What I have been discussing so far has been a little bit more of background of the thinking. I discussed that growth as such is for most or almost all companies, very crucial.
In our case, what brngs 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. 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. In Liisa's 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. If Nubeqa is at all as successful as we believe it will be, it...
We are facing much bigger decline in sales and profitability than was the case after the Parkinson product line lost the patent protection. We need to be prepared. When we think of the ways to prepare, of course, we could just let all the profits go down, increase profits, pay more dividends, which might be a very, very nice for a while. Ultimately, like when I started, I discussed that we are talking about long term. That would be a, in long term, quite a strange strategy. We need to be able to reinvest big amounts of that money into something, and there, of course, we are then talking about basically two different areas, which I will then discuss a little bit more in the coming slides.
We can increase our R&D spending and our sales and marketing spending, grow the business, and create shareholder value. 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. These are not we either do this or that, but they are basically just two kind of ways of utilizing the capital created by our growing business. First, a little bit about the R&D and the linked commercialization. The assumption here is that the, in the previous slide, the first slide, that you just grow dividends and this way create value is not sustainable in long run.
Our payout ratio is already quite high, so at least that is not a possibility to create more value because we are pretty much already distributing such a big part of our net income every year. The long-term growth needs to be based on our capability to grow the business. One way of doing that is definitely higher R&D 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 products from our R&D. 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 long run is likely not high enough. If you only earn like 20%, 25%, 15%, 20%, 25% type of a % of your inventions, taking into account that so 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. Of course, we are facing a fairly complicated and challenging question that when you don't partner or give out regions, then of course you cannot find somebody to share the R&D costs with you. 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. 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.
There are risks involved, and the timing of those spending and the returns is the one which we where we really need to find a ways. 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. 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.
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. We currently have probably loan debt taking capacity of something, EUR 400-500 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. 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.
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. We most likely are somewhere in EUR 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 EUR 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. Even this much of money, most likely means that we can target things that support our business.
Like Liisa said, that has been our thinking all the time. If we think of the how much risk there is involved in M&A, I think it's fair to say, especially if we are talking about new inventions, that R&D has higher risk than acquisitions, especially if you are talking about a 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 already included in the pricing of the asset you are acquiring. So 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 go put all your money into one acquisition and do a little bit more supporting acquisitions, the risks probably are somewhat less. Of course, we all know that in sometimes small acquisition, large acquisition, they require exactly as much work in the integration and in the process, so it's not that self-evident. Also, if you buy something where there really is already existing sale, that of course helps as well. 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. That's why it's likely that the capital allocation to those type of assets will be somewhat more limited.
Finally, couple of key takeaways. Profitable growth, I think, is in Orion, like it is in all other companies as well, the way to increase value. Orion is not a startup, but an established company, we need to take care of today, not only the long-term future. The capital allocation needs to find a balanced way between today's returns and long-term returns. Selective M&As definitely can 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.
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 prop will gradually go down if the company's profit levels increase. Me having this financial target related to dividends will be there in place, I'm certain also in the long run. 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.
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 a proprietary product. Thank you.
All right. Thank you, Jari, for the presentation. Next, it's my pleasure to invite to the podium our Head of Corporate Responsibility, Mrs. Noora Paronen. Noora, please, the stage is yours.
Pleasure to be here, and welcome to you also from my behalf. I'll walk you through the sustainability update. We as a company have done really systematic work on our sustainability strategy that we call sustainability agenda. Our approach covers the entire value chain, from the R&D, to manufacturing, to distribution, use, and disposal. We are focusing on these four themes that we have selected based on the stakeholder dialogue, including the investors. For all of these four 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 are reporting to a selected number of ESG ratings as well. For example, we have been recognized by the Carbon Disclosure Project on a 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. 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. This means basically that 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. We have a really strong base to meet the requirements. Our last sustainability report was actually the 14th report. Our report is based on the GRI standards, and we are already limitly assuring by the third party our reporting. The two big things that are coming, first of all, it's the EU Taxonomy. It is the EU's classification system to companies to identify the environmentally sustainable activities, and then us as a company to disclose those. First, set of disclosure obligations is already implemented at the company, and we are disclosing that we are climate neutral company.
That means basically that based on the current taxonomic criteria, that we do not see we are not seen as substantially contributing to climate change or to be an enabler or to mitigate it. The next thing that is coming is that there will be a next set of the taxonomy disclosure obligations for the four new environmental objects 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. For example, one of the requirements that is in the CSRD is the assurance that we already have in place.
What we are doing to meet the requirements is that we are developing our reporting further. For the EU Taxonomy, the thing that is then also applying to us in this fiscal year, that means that Orion is seen according to our pre-assessment, some of the economic activities, so the API manufacturing and the pharmaceutical manufacturing, will be Taxonomy eligible. We are preparing the reporting in that regard.
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, the CSRD, we are also preparing, and we have made the gap assessment already. One of the things that the companies are required to do is this double materiality assessment. We have that already made. We again had a dialogue with our stakeholders and identified 17 relevant material ESG topics. For all of these topics, we made an assessment.
Basically meaning what's the impact of those ESG topics on the people and the environment? For example, the climate emissions that we as a company have, so what's their impact to the people and environment? 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. 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 they might have, or then on the other side, the opportunities such as our Easyhaler business, what that might have on the financial side. We have created this kind of map as well already.
We this transparency that is then being driven here and to having kind of the consistency in different types of disclosures among the companies, then is then intended to help also the financial markets to then take these considerations into account their in their investment decisions, and then also to kind of incorporate these ESG-related risks to the decision-making as well. That's kind of from the reporting perspective. That's something that we need to nail, and that we are well, very much well prepared. Then again, we also want to focus on the material topics as well to go forward and continuously improve also our ways of working.
As an example, for the climate, 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. We know our impacts, and then we have identified and made a roadmap how to achieve our target. The actions that we are making, the concrete actions, for example, we are continuing still the improvements 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. We need to invest on the electrification of our certain processes at our factory. Basically, how we are then creating, for example, steam and heat.
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. In the end, so Orion is about making concrete actions. By far, we are then focusing on the concrete actions, and then only the unavoidable emissions we will then, in the end, compensate. 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. We also assess the kind of the whole carbon footprint of the company across the value chain. What we are now doing, that we have also committed to.
Sorry, reduce the climate emissions across the value chain and also set the science-based targets, so the SBTs. Meaning that we will align our business to limit the global warming to 1.5 degree Celsius. We want to do our part. Although we were seen 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. The climate change is still one of the material topics that we also now in our reassessed materiality assessment saw that this, it's still there. We are setting the SBT target.
First of all, we are seeing and securing that this green box over there, that's illustrating our own emissions, that those, the roadmap that we have made, that's also based on the science. Then again, it will be in more detail about bringing this blue box down. How we'll do that in practice? We already know and have identified our high-intense suppliers, so we are engaging with those suppliers to reduce their emissions. 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 the people on board, so basically getting the whole value chain on 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. This is a journey that we have taken, and we are moving forward. 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.
This is something that also our customers are asking from us, some of them, and also the employees. Great to see that everybody are in line and moving towards the same target. Lastly, I wanted to give you here also a kind of a glimpse or a 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. One of them, a kind of new topic that has been popping up, is the biodiversity and ecosystems conservation. This is kind of a crisis comparable to climate change as well, that we want to, that calls for solutions, we want to be on board as well.
This kind of, for the climate, the path is well known. We know for the fact that for the biodiversity, so the path isn't yet a bit unknown, but we are ready to get into the pathway, and then to initially map the impacts that we, as a company, have or then what our value chain has as well. We have committed to work towards no biodiversity or no nature loss caused by our business or our value chain. We are already on our way, so some of the pieces of the puzzles are already there. For a pharma company, biodiversity is very much linking also to the pharmaceuticals in the environment.
There, again, when we are talking about our own operations, so we have responsible practices of how to treat the waste and wastewaters, but we are also monitoring and assessing our global supply chain, how they are also then doing the same in their end as well. 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. We see now, kind of... We want to get into this journey as well, so also map the biodiversity impact as a, as a whole, from a wider perspective, and see how we can then also contribute, and this will then in the end, also be linked to the EU Taxonomy.
As the key takeaways, as I said, there is really a tremendous amount of different type of regulations coming, not only in sustainability as a whole, specifically today, we talk about only the reporting. We are really well prepared, and we have a strong basis how to build the continuous improvement also in that further. We are promoting the high-quality ESG data as well, promoting the transparency that I seen, hopefully helps also the capital markets community to get an understanding where companies are getting the kind of consistency across the different levels of disclosures that the companies are handing out. Lastly, I wanted to kind of say that it's not only about the reporting.
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.
Thank you, Noora. Now I would like to invite Liisa and Jari on the podium as well. It's the first Q&A session time, the floor is open for questions. If you have any questions here at the venue, please raise your hand and wait for the microphone to come, then you will have the question. First question comes from the not line, but live, Graham Parry, please.
Brilliant. Thanks, Tuukka. 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. 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?
Thank you. 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. 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 promise. The deconsolidation, I don't see any. The reorganization is not the predecessor for deconsolidation, I would say, if you are looking after that. I understand why you ask that, 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.
Can you hear me? Yeah, brilliant.
Yes.
My second question to Jari, on your comments to invest in OpEx, could we expect that despite the growing contribution from Nubeqa royalties, which are obviously very high margin to Orion, would you expect that you'll continue to target this 25% operating profit margin target, and so limits the margin expansion going forward?
Well, I mean, that is one of our targets today. Of course, for 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 this one timer. 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. The target is definitely still there.
We want to be a highly profitable company, I think our multiples in the capital market also expect that we continue to be a highly profitable company. 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, There might be years where because of the timing of the investment needs, that sometimes there's some fluctuation. Definitely the long-term goal is there to continue to be a very profitable company.
Brilliant. Just my final question before passing on. You mentioned about 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?
Well, I think we all know that the U.S. is the biggest single pharma market on a global basis. 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 molecule. 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.
Brilliant. Thank you.
That, of course, would be the big markets, but we already expanded to Asian market, for example. Of course, the idea is there, maybe evaluate a little bit like we have done over the decades in Europe. Gradually, step by step, expanding the operation. Of course, U.S. would be the big jump. The other geographical expansions would be more like gradual, step-by-step approaches.
Okay, thanks. Sami Sarkamies, Danske Bank. I have two 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 two years ago?
Well, I need to correct my sayings here. I can't tell you that the strategy will not change. We are right in the middle of strategy process. 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.
Okay. 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?
Well, like I said, showed in the calculation, which showed both the potential for raising new equity and debt. I think if you only want to fund acquisitions really through operational cash flow, they would be a fairly small one. 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. Of course, they all are connected.
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 that one as well. Definitely it's both needed. 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 a fairly difficult in long run to fund any kind of an acquisition. That's not the purpose either in the future.
Okay. Thanks.
Iiris Theman, Carnegie. Can you comment what kind of growth do you aim to reach beyond 2025? Are you planning to give a kind of 2030 sales target at some point?
Well, as said earlier, we are currently really planning beyond the 2025 and even beyond the 2030s. I'm not going to give any number at this stage. The growth, of course, will continue, hopefully even on an accelerated curve. It's a bit of the same like with the profit target. The growth is not always linear, you know. There might be years when it's really fast or even kind of a 3-year periods. Then, of course, you pick, due to the launches in certain territories or other actions, it might then stagnate a bit. To answer to that, you would probably need to wait for a while.
Secondly, you gave a peak sales target of over EUR 200 million for Easyhaler. Firstly, has something changed, or why I think the target is probably a bit more positive than you have previously indicated? What is behind your thinking? Secondly, does it still mean that you aim to grow at a single-digit rate, as I think you have previously mentioned?
Yes, the Easyhaler, we really increased the our understanding or told to the audience that we think the potential is more, more to the EUR 200 million than to the earlier one. I'm not jumping ahead of the things. Mr. Hao Pan will share some light on the changes in the marketplace, why do we see that there is a higher potential there. Were you referring as a single digit for cooperation numbers?
for Easyhaler.
Well, I think we'll hear more about it.
Finally, just, if you enter the U.S. market, can you share in your thoughts, how much it would cost?
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. You know, how big is your customer segment and all that. It's very difficult to give a certain number on that.
Okay.
It will cost a lot.
Yeah, that we know.
I mean, that I think it's clear because 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. That's why we really need to be certain that we have the right tools in our hands to do that. It will be 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.
Right. Do we have any further questions here at the venue? If not, then we will have couple of question sets coming through the webcast. The first one is regarding Fermion, and this is coming from Jo Walton from Credit Suisse. Thanks, Joe, for your question. Liisa, in your speech, you mentioned a spike in EU demand for APIs around the pandemic. Do you see that this is being sustained? If it is, would it be worth increasing investment to Fermion to increase the contract manufacturing business there? Or are the cost levels such so, just so high that, you know, it makes no sense to compete, for instance, with the Asian manufacturers?
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. 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 generic drugs especially, drives the API industry to the Asian prices. I'm sure that if any Western API company has a very good process and large volumes and you focus, you can also do it in Europe, and it's worth a while to invest in Europe as well.
Thank you, Liisa. The next one comes from Viktor Sundberg, from Nordea. His focus is on the generic business. 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?
I'm sorry. I think we saw the peak, actually, during the last autumn in Orion, both in Fermion and in the generic business. We estimate that the 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.
I think that's very important point, that even if the increases is now slower, it doesn't mean that very soon we will have cost levels which we saw two years ago. It many costs will remain at higher level than we are we're 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 down.
Thank you, Liisa. Jari, you already answered one of Viktor's follow-ups, but still one more. How insulated are you from these challenges, these cost challenges, versus your peers in the generics business?
I don't think we are insulated at all. I think it, really, all these pressures, they affect everybody in the industry.
Thank you, Liisa. We still have time for a couple of more. This one comes from Graham Parry from Bank of America. What are your key targets and metrics for M&A?
A good question. As I said, the M&A is not something that we would push for any price. I, and I not mean the price of the acquisition. It's more of a what do we really need? It might mean a vertical integration in our generic industry, it might mean a 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-
Yeah.
that question.
Follow-up, that would this be then primarily R&D products that you are targeting?
I think it's really more of a capabilities, either on a commercial front, new geographies, or product, commercial product portfolios, or then, as I said, something to do with the whole supply chain or value chain to build up some competencies there.
Thank you. The final follow-up goes actually probably to Jari. Are you happy to do an EPS dilutive share issue to finance a pipeline deal, or would deals need to bring profitability to offset the share dilution?
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 these timing questions that will it immediately do that? Will it do it longer run? That, again, on the other hand, is dependent on the type of acquisition you are talking about. Definitely, of course, the share issue will dilute, and that's why one needs to be very careful in using that the target for that money should really be so good at that it actually can more than compensate the dilution when you are issuing new shares.
Thank you, Jari. Noora, congratulations. You emptied the table with your presentations. 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. For the webcast viewers, please rejoin us at 2:30 P.M. Finnish time. We will have the next set of presentations online. All right, 15-minute break now. Thank you.
Nice to see and hear so much. Welcome all the webcast viewers. We are ready to begin our second set of presentations. The first speaker will be Outi Vaarala, the head of our Innovative Medicines Business Division, and also Orion's Research and Development. It's my pleasure to invite Outi on the podium. Outi, please, the stage is yours.
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. Here we have the important disclaimer, particularly important when I'm talking about innovative medicines. Liisa already touched the bases 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 the 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. In this model, we can now work according to the business model that is the best fit for innovative medicines.
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. 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, 2022 and then 2023. 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. Nubeqa, the old friend, is the major driver of this growth for us, as you can see. We have more to come. Let's first use some minutes for darolutamide, discovered by Orion R&D and marketed with brand name Nubeqa by Bayer now.
We have seen the success of Nubeqa in the first two phase III studies, ARAMIS and ARASENS. We have still, in our pipeline, together with Bayer, two phase III studies ongoing. We aim to expand further the indications for Nubeqa in prostate cancer. 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 guarantees further growth beyond 25. Here you can see the milestones and royalties for us during this early time of the collaboration. You can appreciate that the numbers are higher in the future, of course. The short-term growth is based on Nubeqa mainly. We still have canagliflozin there.
We will get the CHMP EMA's opinion for the market approval application very soon for that product. It is a product which is much, 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. 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 signal of efficacy in our 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. Again, we have a solid basis for this project in our clinical pipeline.
We know that this target, NaV1.8, is validated for pain treatment in preclinical models and also in early clinical studies by Vertex. That's the reason why I can say that our mid-term 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. In the long-term growth, when we go beyond 2030, we have our robust research project pipeline 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.
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. 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. That's easy to understand. 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.
It was a natural thing for us to do this in-licensing of ODM-111 asset, because our own research and literature showed that NaV1.8 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 acute 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. 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. Our expenses in 2022 for R&D were around 10% of the group net sales. High percentage when you look at the Innovative Medicines net sales, this is going to continue. We are building our pipeline, we are building our future growth, 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 a, how would I say?
Very high threshold for our ideal level projects to become research projects. 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 eight research projects in our research project pipeline. About three of those will deliver candidate molecule during the following 12 months period, meaning that we have, again, after two years, at least three clinical new projects in our pipeline. Pain research areas, ion channels are still there, important regulators of pain signaling. 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. Neuroimmune interaction is one area in our interest. In oncology, as I said, we have expanded beyond hormonal cancers, cancer genomics. Cell signaling is in focus. Immuno-oncology is very important now for us, particularly when it comes to second-generation immune checkpoint inhibitors. We have also a group working with antibody-drug conjugates to find better treatments for cancer patients. We are nothing without collaborators, 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, we have collaborators helping us there.
Also, academic collaborators are important. After our latest CMD, we have here delivered three new clinical projects: ARASTEP, darolutamide, new phase III study, ODM-105, ODM-111, we talk about. I think that we have a solid progression in our clinical pipeline. Some words about ARANOTE and ARASTEP that are ongoing. ARANOTE is a study where darolutamide is tested in metastatic hormone-sensitive prostate cancer without chemotherapy, we will have the readout 2024, launch 2025. 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. This patient group is, of course, a big one. There we hope to have the launch 2027, around 2027. Some words about ODM-208.
It is discovered by Orion scientists and developed by our R&D now to the phase two, which is still ongoing. We partnered this molecule with Merck last summer. The plan is to proceed to phase three studies by the end of 2023. We have published and revealed some data, immature data, but still important data in the last ESMO meeting last September. I will show you just some data where you can see the efficacy signal of this molecule. Sorry. In this phase two study, 50%, more than 50% of the patients actually achieved serum PSA reduction. You can appreciate that in these heavily pre-treated patients in the late line, it is a very good signal of efficacy.
As we expect, the steroid hormone levels decrease to unmeasurable levels in almost all patients. About our newcomer in our clinical pipeline, ODM-212, which is about to enter clinical phase, hopefully in the autumn 2023, 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. 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. The third role of YAP/TEAD activation is in the tumor microenvironment.
YAP/TAZ 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's 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, non-addictive, oral small molecule blocking NaV1.8 ion channel, that has been shown to mediate pain signaling in preclinical models and also in the early clinical studies. Our P hase 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 acute and chronic pain indications. We aim to start those studies in 2024. As I said earlier, we have also several new molecules in our research pipeline that differentiate based on their 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 mid-term for 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 than we are in the Orion 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 phases without any obvious issues. I think that with this I can end and say that we have managed to guarantee with our pipeline development, the best opportunities for the growth beyond Nubeqa. Thanks.
Thank you, Outi. Science is fascinating, don't you think?
I think so.
Yeah. I bet we will have questions later on, but now it's time to invite Hao Pan to the stadium. 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. This is Hao's first time here, and it's my pleasure to introduce you. Please, Hao, it's time for you to take on the stage.
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. Sorry. Okay, I'm responsible for the newly set up Branded Products division, and we are very much set up to focus on Orion own developed legacy products to make sure we maximize its value. These products have served Orion extremely well, and they are no strangers to you. 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 Product division was EUR 278 million. This year, quarter one results of EUR 60 billion net sales consists of 54% in Easyhaler sales, about just over one-third in entacapone products of Stalevo and Comtess, Comtan, we have 8% in our HRT range, and 2% from the others. Our geographical focus is very much in Europe, but also now in Asia and Pacific. The three key product ranges here, so Easyhaler, entacapone, Divina series, dictates our playing ground, so called, in the therapy area of respiratory, Parkinson's disease, and women's health. In terms of the building blocks for growth, so how are we gonna 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. We mentioned about Easyhaler, I will talk a little bit more, entacapone, and also HRT range. We will use this portfolio to build on our strengths 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 gonna do that? We still have internal R&D, so that hopefully will generate some new products. 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.
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. Also the M&A, which Jari and Liisa both have already touched upon. A few words about Parkinson's disease and Orion. You all know that entacapone products have already lost this patent 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.
This 42% after 11 years is actually quite interesting to me, because first of all, it 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. 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. That again just shows we are in this game for the long run. Indeed, we are committed to remain in this, 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.
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 all our products in a smooth way. What's more important, we want to maximize the heritage we have in Parkinson's disease and to really build for a future. As we speak, I'm 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. 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.
On to Easyhaler, and I'm hoping I can explain the reason why 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. This is actually quite an important factor, unique to this range of products, which I will touch upon. We have already delivered over 100 million devices to patients worldwide, and we are very much committed to sustainability, sustainable lifecycle management with this range of products. For example, our relatively low, in comparison, relatively low CO2 emission per device stats has been further reduced.
During the last 3 years, it went down from 0.58 kilogram per device, CO2 emission, down to 0.55 kilogram. Every little things really help here. Even though, you know, 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. Talking about sustainability, Liisa already mentioned this is the mega trend that nobody can really ignore, and indeed, it becomes more and more relevant to us. Recently, healthcare systems are doing their bits as well. They are starting initiative to really set goals 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. 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 powder inhalers. Dry powder inhalers is probably about, you know, you talk about 18 times more ECO2 emission in a metered dose inhaler compared to a dry powder inhaler. When you add them up together, it is becoming quite a meaningful thing that we can all do something about. Here are three examples, and they are all quite recent. The first Global Initiative for Asthma 2023 guidelines. This is the GINA guideline. For those of us who work in the field of asthma and COPD, we all know this is really a very important organization issuing guidance worldwide.
For the first time, they're actually saying, and this is actually May, this month, early on this month. "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." That's actually a very strong message. Already back in autumn last year, two of the biggest European markets, U.K. and Germany, for asthma and COPD, you know, you have already got guidance. The NHS in the U.K., in England specifically, set this net zero 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 powder inhalers. The German guidelines, which was issued, climate conscious prescribing of inhalation medication.
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 than you are not taking a flight for over 1,000 km, or you're driving 1,000 km less. That really shows that there is meaningful things that we could do there. 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.
What's more interesting, because I talked about the six products with Easyhaler, four of them are in single molecules, and in some countries, there aren't many options in terms of dry powder inhalers in these single molecule segments. For example, beclometasone in U.K., which is a large country, Easyhaler is the only available dry powder inhaler. That just give you some example of that. 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. 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.
If they need to use a combination or if they need to prescribe a combination product, then of course there are channels for us as well in the combination market. That's why we are quite confident to actually issue the new forecast of this EUR 200 million in annual sales. 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.
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 the 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. Also, we need to manage possible pricing pressures and also possible changes in regulations in certain markets and countries. 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. Apologies. The take-home message here, three very simple message here.
First of all, we believe the green transition really create future growth opportunity for Easyhaler. Secondly, Orion remains a leading company in Parkinson's disease. 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. I thank you for your attention.
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. Here, actually, we have a real concrete example of that, you know, it might create opportunities for companies. Luckily, we have now this opportunity ahead of us. The next speaker will be Satu Ahomäki. She's representing the Generics and Consumer Health business division. Please, Satu, the stage is yours.
Thank you, Tuukka. 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%-90% of the track volumes are created by the generic products. All societies and the healthcare systems, they need generic products, otherwise they couldn't survive, and not all the people can be treated with the innovative medicines. This is just as a pre-word disclaimer. Here we have the overview of the generic business and consumer health in Orion. Our purpose is to create everybody an access to affordable quality medicines, and also help individuals to promote their health with self-care medications.
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 two different factors. First is Russia. We have had good sales in Russia, but this year it has declined. The second reason is Simdax and Dexdor. They have faced even more generic competition, and prices have eroded. Of course, in this business, pricing and the good service level, they are really the key success factors. 3/4 of the sales are coming from the generics and then 25% from the consumer health.
Majority of the sales, 56%, coming from Finland, followed by Scandinavia and Eastern Europe. This business has been really a bedrock for Orion for many years, and when you look the graph on the left-hand side, you can see that it has really shown a solid growth over the years. Earlier, it was basically, it was called Specialty Products, a little bit different product mix, but in essence, it's very much the same than this current business division. 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 Finland, in the pricing, and system, and the regulations changed. There is this we call it price tube, 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, that's why it hit us. After 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 it from different dimensions, we tend to be number one always.
In terms of how many employees we have, how much we invest in R&D, and also when we think about our market share. In the total human pharmaceutical sales, Orion market share is 11%, which is, of course, very, very high. In the reference priced prescription drugs segment, it is 24%, and in consumer health, so self-care product through the pharmacy channel, it is as high as 26%. 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, you know, when you are number one, the rest of the pack is after you, and they are running fast as well. Every day we have to deserve our place again.
The current situation is that we are doing quite well, but still there are some limitations for our growth. The over 50% of our sales are coming from Finland, and we know that the number of people are not expanding here, so we have to create the business outside Finland as well. We are in a way, dependent of the external supply chains. They are in a key role, and that's very typical for this business. 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.
We have six plants in Finland, of course, to really take the full advantage out of that, we have to secure these volumes and volume growth also in the future. What would be the way forward? How to change this current situation, how to find the growth, and you need to have this think bigger mindset. It means that, of course, we want to cherish the current business. That's very important for us. On the other hand, we need to find the growth through new products and also from new territories. Inorganic growth has been an activity, has been very important for years in this business. 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 at product 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. Then we continue the development of these generics, but we have to go big. We have to go to these big markets in the Europe as well to really catch the volumes. Of course, we can't compete with all Indian companies, the hyper generics, so we will focus on the complex generics. They are a little bit less competition, hopefully, and also to value-add products. Increasing value chain integration, so there are several things how you could do that. It's in the API, the finished products, the packaging.
Usually, when you have a bigger hold of the value chain, you manage the whole value chain. You usually are able to also enjoy higher margins. Of course, it's not always like that, so there you also have to quite carefully think about your, what are the right steps, but this is something what we are evaluating. We are really in the process of thinking, well, what would be the next steps here, and maybe that's the one sign about this focus. We have people who are fully focusing on this business division only and what's good for that. We have a huge portfolio, over 2,000 SKUs, and in order to manage that better, we have divided it 3 different segments.
We have this generic prescription products for hospital use. There, of course, the hospitals, the hospital pharmacies are our key customers. There, Simdax and Dexdor are really creating the foundation of that segment, added by the biosimilars. We have a long-term collaboration with Celltrion, also made two years ago a deal with the Curateq Biologics , also new launches through in-licensing and from the Amneal collaboration. I will talk about it more in a bit. The second check segment is the generics for retail use, the customers are pharmacies, and outside Finland, also pharmacy chains. There we very much rely on the current home markets, in Nordics and Eastern Europe, which has been the bedrock for this segment.
Also we are planning new launches then outside those territories and look growth from there. 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, free pricing, for instance. It really encourages you to think about how to develop your portfolio and also territorial expansions. This is again, an example what we are currently examining. I promised to talk to you about Amneal collaboration. This is something what we published in January, the strategic partnership with Amneal is a U.S. company, fully integrated pharma company, and they have in their diverse portfolio, 250 generic products, and also a strong pipeline. In with this exclusive license deal, Orion has...
right to develop and commercialize Amneal products in Europe, Australia, and New Zealand. 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. Also the regulatory pathway, there might be differences, so we might need to do something extra for Europe.
We go through one by one, though, all those products and what is in the pipeline, and then we make these decisions. I'm happy to say that we have already started that job, and a couple of decisions we have made already, and the launches are then expected in coming years. Very excited about this collaboration. As it has been said, that this business division is the 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. This is a very dynamic business, of course, and therefore the continuous renewal, it's a must.
We need to manage the portfolio also very well. It's a type of business where the portfolio, 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. What we need is a vigorous product flow through our own development, through in-licensing, various alternatives, as I discussed. Also we need to improve our competitiveness. As I said earlier, we are not in that hyper-generic, cheap, cheap market, we try to look for opportunities where are a bit less competition, something that where we could really add value and where we could meet the requirements for the competitiveness.
Territorial expansion. We are number one in Finland, among top 10 companies in Scandinavia. In Poland, we have been many years the fastest growing generic company. As said, it's really not enough if you want to go to the next level, so we need to conquer these big European markets. Those are really the building blocks for the growth. I'm actually ending my presentation with this slide, and I have three 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.
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. Niclas, in your new role, please.
Thank you. I was actually thinking that maybe I should start where the other one stopped. Basically, when I was listening to Satu, she was saying we need to go wide, and we need to do that. Where I actually come from now is, in my previous job, I was responsible pretty much for sales, marketing, business development in the Animal Health division. Today, we're actually a business with a production side, a logistics side, and now actually from mid of May, also our own R&D operations. Clearly, you know, 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?
Just before we go there, I think that one thing you have to put into context is, if we look 10 years back or 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 chains, the integrators in poultry. All these companies are becoming bigger. On the other hand, also, the pharma companies have gone together. 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 big fish in a small pond. We were in Scandinavia, we were representing the big boys in Scandinavia and in the Nordics.
Now, what happens is, of course, that the world is getting smaller, and when the consolidation is gone that far, that the big companies almost cover 70%, more than 70% of the market, you either have to you know, step up and go outside your own comfort zone. That's what really what happened last year with the with the acquisition of Inovet. What we really did was we actually both 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.
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? When we actually went into the acquisition with Inovet, 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. These things, when we start taking into consideration, the challenge for us is, of course, how can you make it work from day one?
Of course, what we have done since the acquisition is really trying to integrate, build, and combine the different opportunities in the two companies. 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... Oh, 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. Of course, what our business is much more wider foundation. I mean, we're 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, we also have launched some services globally. 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 not are, we also out-license products for certain markets where we have a lesser presence. Clearly, our focus is becoming more and more to be the owner of the value chain.
That's why, for example, now when we look at where we're focusing on the over the next six months, is really getting certain products which we have from our pipeline into the markets where Inovet is present and where we were not present earlier. Everybody asks me: "How can you say you were innovative animal health company?" Of course, the best way of showing that is really to show some kind of a track record. Clearly, for us, if we think about everybody who knows R&D and development, and we have had these discussions over the years that how much did we benefit from the human R&D? A lot.
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. If you look at some of those products now, for example, in 2021, Tessie year, new indications, new world, 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're 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. Our key message today is really to make the most of the combination of Orion and Inovet together. The thing here is we really have a sort of opportunities. We have a functional company, but of course, we have a lot of corporate knowledge and processes which we're gonna drive in there, and of course, make sure that the compliance, the world, everything is met to the highest standard and go forward from there.
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. We are going forward. We do some exports outside to Asia and to Africa, Latin America, and the U.S., so really from that point of view. Also, when I was listening to Satu a while ago, when she said she had the most of the people of Orion generics in Finland, I was thinking that, well, actually, for animal health, most of our people are actually in France and Belgium, and we're actually sort of a really small part in Finland.
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. That's clearly one of our opportunities going forward. Of course, there's the discussion on livestock. Where do we focus? We focus really much on poultry, and that is also a very consolidated market around the world. 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. I think that sort of gives us also have an opportunity now with a bigger organization and bigger footprint to actually push that forward.
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. I think that, of course, there's two ways of growing a business: it's more products or more markets. Clearly, those two are we now expressing from both ways. I'm very glad from the side, even though I admit that we were 9% of the turnover last year, and that Orion is still committed to give us the opportunities and the wind to actually under our wings to build that forward.
Of course, when we look at what's really how do we make it the most out of Orion and Inovet and the step change? I mean, really, for us, the most important thing is the customers. Of course, when I said we're becoming deep, it's also that we have very different customers. 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.
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, were around 6% of the global market, which was the Nordics and Eastern Europe. Of course, with the new opportunity, we're 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. 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 gonna do, it's what you're not gonna do. You have to make sure that you don't spread your efforts too thin, so you really focus on the areas where you can make a difference. That's what we're trying to do now, is really to find those winning concepts to go forward. 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. Clearly, that's an opportunity to us also to deliver products around the world. Of course, the geographic expansion again.
That is really the key. 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 for my size of company, because I had 500 people in R&D, because we used the human ones. Now what I say is that we have a dedicated team really working on R&D, which is going to give us the real focus, 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 are looking for their own, but now we have an opportunity to have a dedicated new product opportunity.
As it's not been customary to disclose these opportunities, I still don't gonna do it unless I'm being asked in the future. The only thing I can say that for once, there is a lot more opportunities than threats. 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 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. Any questions? Let me see, I can leave enough time for questions now.
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. Of course, as you are learning, the whole group is learning, should there be any future M&A, you are actually teaching the rest of the gang, so.
Yes, well, it's a new experience for all of us, even though I'm a longtime Orionee, I never really gone through a similar one inside of Orion. Outside, yes, clearly, this is something where we... I think, well, this is one of those where ask me tomorrow or ask me the day after that if people are happy, so.
Thanks, Niclas. 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. I think our management team is fairly efficient also in this way. 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. Shall we now start with Sami, because Graham Parry was first in the first session. Sami, please, we are ready to take your questions.
Okay, thanks. Sami Sarkamies, Danske Bank. Starting from Outi, I have two 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, why is that? I mean, why are you treating it differently to the other programs?
Well, the reason for that was that actually ODM-212 was included in the research projects that were under 208. It's of course, part of the long-term growth factors. ODM-208, it can give the growth for us in mid-term, around, beyond 25, and it brings, because of the patent life also life, also, growth for us longer. 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.
If I may, Outi, add here that actually also the other programs are included in the longer term, to be honest, there was too little space for all of that. Actually, that's also a sign of our more robust R&D pipeline currently. Good question. Thanks.
Additional growth drivers. Yeah.
Okay. Continuing with Outi, could you give us a few examples on target indications for ODM-212?
Examples of target indication for ODM-212. When we talk about this acquired drug resistance, you saw the treatments that are mentioned there, like EGFR inhibitor, and so on, of course, we, 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 one example.
Okay, 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?
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.
Okay, thanks.
Brilliant. Brilliant, thank you. Graham Parry from Credit Suisse. My first question's on oncology, where you have quite a strong track record in small molecule drugs to treat hormone therapy. As you mentioned in your slide, 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?
When it comes to biologics and antibodies, we can differentiate, for example, with bispecific antibodies, when we have a novel target pair there. We have in our research pipeline projects. I hope that I can talk very soon about them and reveal the target pairs. That's the differentiation. We are talking about, in a way, first-in-class ideas.
Brilliant. 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 study required by regulators, especially with regards to the non-addictive claims, potentially of that asset. 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?
I need the disclaimer slide again. I can base my views now actually on the published literature. NaV1.8 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 such as neuropathic pain and osteoarthritis. That's the evidence we have at the moment. Of course, we follow science, we follow that evidence, then you can guess what are the indications that we are aiming. When thinking about the length of the studies, 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.
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 on, it's important to do a very aggressive and broad clinical development plan. I was referring to that when I said that we needed to do focusing on pain, because we want to resource fully this program. It's not about us if this program fails. We put our all resources to be successful.
Brilliant. My final question is just on the new Easyhaler target. The 200 million or greater than EUR 200 million sales over time, can you maybe just give an indication as to what is 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? Maybe then to just include within that question, the... I guess, the significant, you know, 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?
Thank you.
Yeah. In terms of from my presentation, you can see that when I was describing about this new EUR 200 million, I keep talking about our portfolio, so we have 6 great products. 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. 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. A lot of devices, for instance, U.K. and in Germany, still over 90% of the devices in single molecules are still in metered dose inhalers. The market is quite large, so that probably is somewhere that we can see some improvement on what we can do.
Also, of course, with some dry powder inhalers in the combination market, the dry powder inhalers are more dominant, or more equal in terms of where they were. There are country-specific differences, so it's quite a complex picture trying to answer that question. We trying to monitor and adjust what we do country by country, molecule by molecule, trying to get the best out of everything.
Brilliant. Thank you.
All right. Do we have any other questions currently from the audience? Sami, you have a follow-up?
Yeah. Yes, I have two questions for Liisa Hurme. 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?
For me, because, 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. I would say in terms of engaging with stakeholders, you know, 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. Again, without trying to giving you a sum, but this is where we strive to do better in the future.
Okay, 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?
Yeah. Again, we don't give projections like sub-products or subgroups. 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, you know, 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.
Okay, just to be clear, you're trying to grow sales from current level, so it's not like a defensive move only?
It's really as Hao 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.
Okay, thanks.
Any further questions here in Helsinki? If not, I still have couple of more coming from the webcast. We can start with Outi and ODM-212. Graham Parry asked the same question as Ari, that what might be the... Or was it Sami? Sorry, cannot remember. What would be the initial target indications? You already mentioned that lung cancer, as an example, one possible indication for that. First we need to tackle the Phase I hurdle, and then we will move forward.
tell more.
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. 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. Again, thinking about the environment, Inflation Reduction Act, and so on. That's an important indication, but we need to do wise decisions about the indications that are really important for the patients and commercially available for us.
Thank you. We can still continue with ODM-212. Viktor Sundberg from Nordea has 2 questions. 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 that challenge with your TEAD inhibitor? The second question is that, in addition, data from competing molecule IKT-148009/VT3989 was presenting just recently in AACR. Any comment on that data and on the differences between ODM-212 and that molecule? 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?
Yeah.
Yeah.
That's true.
When it comes to the other question, so basically, it's not appropriate for us to comment on competitor's data. 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.
I can add to that, yes, it's true that many companies have struggled with this pathway and with the TEAD inhibitors. 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. We are encouraged by the data from VT 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. We consider that data actually encouraging for us. As you all know, in oncology, we can tolerate more side effects than in other indications, like, for example, in pain.
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. 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.
All right. That was a good answer. Thank you, Outi. We have no further questions from the online. We still have here a follow-up from Graham Parry. 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. Now, let's give the floor to Graham Parry.
Brilliant. No, thank you. I'll ask one on animal health, please. The you mentioned a lot about geographic expansion and the U.S. market. Clearly, that's the largest market for animal health-
Yes
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, you know, commercialize in the U.S. yourselves, or is out-licensing maybe a preferable option for that?
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, and we've been very satisfied, and the collaboration has worked very well. I think that's really been the cornerstone, and now we have actually two 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." At that time also, you have an opportunity to use the partners or the collaborators you work with. No, at this stage, U.S. is actually not in the target.
Great.
There's plenty of room outside.
Brilliant. I also had a question on generics. Clearly, the capabilities of engine manufacturers have increased over time, whilst you probably point to, you know, 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, you know, where Orion can differentiate versus, you know, some of the lower cost manufacturers, and, you know, how that might be able to stem, you know, this ever-declining margin that we've seen in generics over the like, the last few years?
Yeah. Thank you for the question. I think that 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 prefill syringes or somehow improving the current products to offer something more for the customers. Yeah, I don't want to give any exact examples, but that would be the way to go.
Brilliant. No, thank you.
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.
Okay, 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 you've been quite cautious with R&D investments, what is a realistic scale-up plan for the Orion internal R&D?
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. 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, you know. It's a very different thing to develop by yourself and start to plan the commercialization by yourself. We have relied a lot to our partners this far, and Outi, you may continue on more on.
Yeah
R&D.
I, of course, I agree with Liisa 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, we have had when it comes to developing our discovery skills, we have been successful in the recruitment to Finland. 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. 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.
Yeah, 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?
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 medicine side. If you would think it's a company only selling innovative medicines, it's actually a rather high percentage, but even on a corporation level , I expect that to slightly increase during the coming years.
Okay, thanks.
All right, we have question coming from Iiris. Just a moment.
Iiris Theman from Carnegie. Just on a 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? Thanks.
Well, I think Liisa already referred to that in your opening words. 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 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 implications, it's too early to say. We don't even have the new government yet.
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, on that market.
All right, thank you. No more questions here at the venue. Going to webcast, and Jari, you will also have one question. This is coming straight to you from Graham from London. Sorry, Graham, I missed your question earlier, but here goes. Jari, you seem to suggest operating margins may fluctuate around the 25% level, you know, 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?
Of course, we are not giving this exact year-on-year guidance. It's very much linked to what will happen, especially in the iMed area, that how do the R&D programs proceed? As we all know, of course, phase 3s 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? How much we are partnering, and so forth. If we take a robust look in ourselves, the more we do ourselves, then of course, the short-term impact is negative on our profitability, so it will decrease. 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 a development, is only in phase I for the time being. We still need a lot of more data before those final decisions can be made. I think that's clear that if we go forward with this expansion of our own operation, that will, in mid-term, decrease the profitability to some extent. Of course, it also depends on how well Nubeqa is doing, because lots of the growth, on the other hand, is coming from there. The more come from there, the more we of course have money to invest without decreasing the profitability.
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.
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.
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. Just to summarize: growth driver, Innovative Medicines in a big scale. We have the solid bedrocks. Of course, all of those will grow as well. The biggest of those is Generics and Consumer Health. You saw already in the beginning how big role that business division has. Sometimes we are asked even today, you know, whether we are too diversified and we have so many business divisions. Imagine if at the time of Stalevo genericization , we wouldn't have had the Specialty Products and Generics. I see that it's extremely important to keep a very balanced business portfolio.
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. 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?
I hope that we have been today able to convey a message on that as well, that there are some of our old products, so to say, which still have a lot of potential to grasp. We have extremely good, strong pipeline to the company size of Orion and validated. We have businesses that are supporting the growth. Thank you for your attention.