Thank you, Tuca. Very warmly welcome. As Tuca here mentioned, it's a beautiful sunny morning here in Helsinki. And I hope you're enjoying the weather wherever you may be at this time. If I'll start, we have our whole Investor Relations team here present here today.
And here, you see the Orion Executive Management Board with the eight members. We have presentations here by Sattu. She leads the Commercial Operations. We have a presentation also, of course, by our CFO, Jari Kasum, most of you are familiar with. Birve Leitenen, who runs the Specialty Products business, will say will discuss about the generics business.
And then obviously, the future will be discussed by Krista Noostet, who runs our R and D. And he will be joined to the podium by Professor Heikki who runs our Oncology Therapy area. And as said, during the break time, we are all here available. You will notice all the Orion people who have this oval name tag here. So any thoughts, questions you may have, please pop and state your questions.
Okay. So as Turca said, the agenda, we have first two presentations. We take a short Q and A after the presentations by each one. Then we have a little bit longer break, so then there's an opportunity to mingle, state any comments you may have, questions. And then we'll continue with the two other presentations and then the concluding remarks.
And as said, the ones who stay here choose to stay here, there's lunch available as well. That's the rundown of the day. Okay. So of course, the main story that we have is the growth story for Orion. But just to remind us what of a company we are, so roughly about the 1,000,000,000 company last year.
And all the numbers that we present here, those are from continuing operation. Some of you may remember that last year Orion decided and did divest Orion Diagnostica, but we've cleaned up the numbers from that and these are present only the continuing operations. The company's hallmark has been profitability. We are a company with more than one hundred years of history. And of course, being in pharma, given the risk profile of the industry, we need to make a profit as well.
Today, we are about 3,100 people in the company and roughly 700 of those are outside Finland. We invest about or expense about EUR 100,000,000 in R and D roughly. That's our own money. Then given our business model that we also operate with several partners, of course, then that gets multiplied. We manufacture our own products only in Finland and that then will be supplemented by several partners who produce products for us, which is very typical in our industry.
Nobody manufactures all of their products by themselves. So you will always need good partners, but Orion's own production takes place only in Finland. Our commercial footprint covers pretty much across the Europe today, including then former CIS countries, most notably, of course, Russia, Ukraine, Kazakhstan, where we are present with our own commercial presence. Now if you look at the split of the business for the last year, the specialty products, which comprises of the generic prescription products, OTC and biosimilars and also non pharma products that are typically sold through pharmacy channel. That was the biggest business.
Then came the proprietary business, which is for us the R and D driven business. On the top of that then we have Animal Health, Fermion and also Contract Manufacturing businesses. Out of all the markets, Finland continues to be the largest single country market. Obviously, the large European markets, The UK, Germany, France, Italy and Spain as a totality are larger but out of the single markets. And then, of course, also Scandinavia is very important for us.
And then Eastern Europe and CIS countries because especially our generics business is focused very much there. Today, our exposure to North America, most notably The U. S, is limited due to the patent expiries of our largest products in those markets. So the story for the growth. This is something that we came out this early part of this year, put the poll to 1,500,000,000.
And here it is good to know that actually this is more of a communication matter because even earlier we've said that our goal is to grow faster than the underlying market. Now what this implies to, if you do the math, it implies roughly 6.5%, a little bit less than 7% growth, annual growth on a CAGR basis. So it's not that we are trying to reach the moon out of the sky. This is growing a little bit faster than the market, but not by the factor or anything. But of course, communicating this both internally and externally, 1,500,000,000 is more catchy and easier to communicate faster than the market.
And one of the tools how we are now growing to that is to invest in growth. And those means were given as an example by the divestment of Orient Diagnostica and that releasing that capital, which is now available to grow, to fund the growth of the business and also at the same time continue to maintain the attractive dividend payout. What we said that the some of the investments that we have already undertaken underwritten, one is the Phase three trial for the ALS symptomatic treatment that we are running. Typically, we would have run this within a partnership with our company X, but now we are taking the underwriting the entire program by ourselves, taking the risk thereof and should the trial work out also, of course, reaping the benefits of that. And that investment alone is EUR 60,000,000 over a three year period of time.
We've also initiated a program to augment our own pipeline by in licensing or acquiring products. And now we've in the past months, we've already completed two acquisitions. One is reacquiring the rights to Stalevo in Europe as well as for Compton product, so our original Parkinson's franchise products. We've also put a little bit extra effort in our sales and marketing operation in Germany, the largest market in Europe, especially focusing on ezHaler. So we more than doubled our sales force efforts in Germany in anticipation that we will actually outperform the market.
So in totality, all of these for this year, we estimate that we get burdened by about CHF 30,000,000 in our P and L with these investments. And that would include as an example of writing down the acquisition of Stalevo in a two year period. So it is very, very conservative bookkeeping that this company has and I think we are all very proud of that. So if we think how the value gets created by our different lines of businesses, of course, the proprietary products, that is the growth engine for the future. It depends on the IPR, on the patents, on the exclusivity that can be created by running clinical trials and in many jurisdictions you actually get the rights for that those data.
We've also decided that actually we will focus more our R and D efforts within the therapy areas that we've chosen, meaning oncology and CNS. Maybe in the past we had that we were a little bit more opportunistic, but today we are very much focusing in certain niches within these areas. We are by no means shying away from investment in R and D. On the contrary, we have a very strong belief in R and D that that will be one of the key drivers for the company and also building the competencies that when the opportunity proposes itself that we can acquire something externally, we need to be able, of course, to firstly evaluate that, make a wise decision on that and then to develop that, place it to the marketplace. So very important.
The specialty products have a very important role in our business lines. It has a very strong market position. It has genuinely the scale of economics in certain markets where we operate. We have focused our markets effort there in Scandinavia and certain Eastern European countries as opposed to the truly global business of proprietary products. Oleum brand, of course, we focus on that.
We use that as an umbrella brand for quite a few products. And that in a generic business, you need a cost efficient operating model. And I think we are one of the companies who are, of course, learning every day, not saying that we are world champions there or masters of the universe, but we have been able to balance having the both proprietary nature of business, which where you have the longevity, high investment, high risk, huge opportunities. And then the specialty products where you have to have a much leaner operating model. Each opportunity that presents itself is short lived.
You have to have a very fast turnover of products. Then animal health is a very interesting part of our portfolio because that business, as opposed to the human side, it is truly a market pricing. You don't have the intervention by the regulator or the payer because typically it's a cash business. Either you sell to the companion animal owners or you sell to the farmers who have livestock. And clearly, we see is, especially the companion animal business correlates very well with the growth of the GDP.
For our purpose, why that is very interesting is that whatever we develop in R and D, we always see if that opportunity would have utility in the animal health side, irrespective if it advances in the human side to a real product, but then we always look at also opportunities for animal health. So actually, we squeeze out of those assets the maximum. Then Fermion, which is the active pharmaceutical ingredient manufacturer or producer, That produces all of our proprietary molecules for our own purposes. On the top of that, it actually commands a very high market share globally in certain generic compounds where Fermion has been able to capture that market share by being very efficient producer. So the drivers that we see in the global megatrend scheme, what drives the business and how they affect us, of course, one is the aging population.
The entire Northern Hemisphere is aging. And as the bodies as our bodies as they age, we are certain to have mutations. We can not avoid them. Some of them are mutations that barely have an effect during the lifetime. Some of them develop through carcinomas and we develop cancer.
So that is one of the areas where as the bodies get older, we will see more need for oncology treatments. Also, what we see is that certainly the central nervous system was not designed for most of us, unfortunately, to last close to one hundred years. So we will have an effect in our central nervous systems, be that movement disorders, be that in memory side and often also in pain and that's where we are active. So there is no certainly not lack of the business opportunity there. We are all settled in nations by the high healthcare costs.
Now Orion, luckily, we have also products that shorten the time that the patient needs to spend in an expensive ward, be that in emergency care or other that type. And we can bring the patients quicker to the productive life or in the lighter care. Then on the top of that, what we have, we have generic business, which offers quality medicines at the lower cost and thus relieving the resources from something else. Now, is making huge advancements. Over the past ten to fifteen years, we have actually seen more publications in science than during the mankind.
So the science is taking huge leaps. Unfortunately, there is still a lot to do. There are very few diseases that we can cure. Mostly, are treating symptoms. That's the best that we can do.
But even that is very important because that increases the quality of life for many of our patients. And then, of course, only the medicines that are taken as prescribed, taken properly, that actually has the efficacy that was intended, including the side effect profile. That's why Orion is involved in quite a few activities, how we will help the patients to adhere to the compliance of the medication, be that different variables or be that different applications when to administer the prescribed product. And then lastly, of course, today the sustainability, transparency is very much name of the game. Not only does that mean environment, Orion has been one of the front runners by making a commitment to reduce our CO2 burden by 75% in the next six years period.
We've also reduced dramatically our API, so the active pharmaceutical ingredient content in our wastewater treatment close to 100%, also by acting every day in a transparent manner is really what is called for, especially in pharmaceutical and healthcare industry. When we look at then the opportunities that the business offers this entire industry, this is one of the largest industries available. If we leave aside the petroleum industry and the real estate, well, of course, the price of the real estate plays a major role, this is a very, very large industry. So the projection is that we are going to see about 1,500,000,000,000.0 industry over the next couple of years, which mostly is driven by The U. S.
U. S. Is a very important market, commands a little bit less than 50% of the market share today. But when we look at the new products, it is often we see that about 60% of the revenue of the new products actually comes from The U. S.
So it is not difficult to see that whatever product you have in your pipeline, your first goal is to develop that to The U. S. Market and then the rest will follow. Of course, Europe is our home market. That is an important business for us and there are several niches.
Of course, if you introduce new products, you always have the opportunity to grow. So it's not only at the macro level that you need to look at these markets, but in a more refined markets. And then for us today in Orion, Japan is an important market. It's a large market. It's a high priced market until you hit the end of the patent life.
The emerging market, despite the fact that they are growing very fast, their current proportion is still limited compared to the more developed world. So the growth that we will see over the next period is certainly driven by proprietary products. Of course, we have products that are in line products today, so we need to maximize those. We need to be successful in commercializing the opportunities that are in our late stage portfolio. And also, of course, look for in licensing opportunities to augment our current business.
What we have in our late stage portfolio are the darolutamide that will be discussed more by Professor today. We have an ALS program, as I mentioned, in late stage recruiting in Phase three and there are several animal health projects as well. Now, those are the industry has no obligation to disclose those as the competition does that neither, so we don't do that either for competition reasons. But in animal health, of course, apart from the R and D programs, we have a portfolio today that we operate with by ourselves and including our partners. And then, Fermion continues to be an important part of our structure where they are very efficient and compliant in API manufacturing.
Then the Specialty Products have a very unique role, apart from that being a largest business that we have today and we have to get hold of that and develop that. But it has a very strong cash generating potential. It has a portfolio that we need to maintain, look after that, continue to develop that portfolio because the lifecycle of many new introductions there are quite limited. We are also evaluating should there be opportunities to enter into some of the new markets with low key investments, but yet those could bring us incremental revenue. Some of the key themes that we've had for the corporate responsibility, of course, the patient comes always first.
The patient safety is extremely important in our industry. And that's why we've seen the regulators are taking very stringent steps also when they audit different companies. The environment, of course, we are all concerned about the environment. And as said, Orion is taking big steps on that. And an important element that where we have had a major program over the years is for us internally.
Operating in a safe environment and operating safely is a professional manner as well that we are internally focusing on. High ethics and transparency is paramount in Healthcare because in most jurisdictions, we actually operate with public money. So the public also has a reason and I think the right to understand how the tax money is being spent. A couple of building blocks, what we've achieved over the past few years. So we have a great responsibility of having also our products in the market And here is one example of the methotrexate that is used for cancer and some other osteoarthritis or rheumatoid arthritis applications.
We have about one third of the global market for that. That means that we need to make the product available for patients. Also, we audit about 200 to 300 partners annually. We are being audited by more than 100 times a year. Of course, we get also customer complaints and here we track that per million events.
Then, as said, the environment, we take care of that and I think we are one of the front runners in reduction on our commitment of CO2 emissions. Also, of course, then when we do this all in a right manner correctly, the company is profitable, it can generate profit that the company is known one of the hallmarks that it has a high dividend payout. This is in many of our shareholders. This is an important part of holding Orion stock that it has an interesting dividend yield. And here if we look at the longer period of time, of course, there have been a couple of special events when there has been a capital distribution and then when the company had its one hundredth anniversary, we had a special dividend on that.
But it's been a growing trend over the past years. And here we also flagged our dividend policy where we stated the floor for dividend payout of 1.3. And how has that then turned out to be a total shareholders' return? We have two periods here that we are describing. One is a five year period when the TSR has been 70% and compounded growth has been 11% over the years.
And that has been combined by, of course, the stock price appreciation as well as the dividend return. And then when we take a little bit longer perspective here, a ten year period, then the GACAR has been roughly 17% and about half of that in stock price appreciation and about half of that in dividend return. So those have been the sort of the end result, how you can judge us, which we believe is a very attractive return also to the capital markets in our industry.
Okay. Good morning from my part as well. So I will kind of continue with some of the themes Timo already started with and also some of the themes already discussed during the questions. So I'm not going to go through that much of a number, but more like the growth themes. And I think the title already here very clearly says that while we want to achieve growth, definitely, of course, we want to also make it in such way that we maintain good profitability of the company.
But just a reminder, we have not changed our financial targets. They are the same as they have been already for several years. So growing faster than the market, maintaining good profitability with operating profit of at least 25%, strong balance sheet and also good dividends with, in the longer run, growth in the dividends. And if we look at how we have performed against these financial targets, one can clearly see that the one where we have had some challenges over the last few years is the growth. So the profitability, dividends, balance sheet, all of those, we have very well achieved the targets we have set to ourselves.
But growth definitely has been a challenge for us. And why we are now talking so much about the growth? So there are a lot of different reasons why growth is important. But of course, one of the key things is that no matter how well you manage your cost structures and your operations, the fact is that if you don't grow in longer run, it's going to be very difficult to maintain the high profitability of the company. But also, when you have a lot of scale, it helps to carry the overall cost structure.
This is an industry where you have to have a fairly large fixed cost base. Quality, lots of other things demand a lot of money and the bigger you are, the smaller share these certain fixed type of costs are out of your total income. And that, of course, helps in the profitability and helps, of course, in the return of capital employed as well. Larger scale of opportunity, of course, also it creates an opportunity to proceed with higher risk opportunities And of course, also the bigger you are, the more resources you have to execute some of these growth opportunities. So the growth as such helps you to achieve more growth.
And then, of course, finally, the fact is that if you are not growing, it becomes increasingly difficult to retain the talented people if you cannot provide them growth opportunities. So that also is a very important aspect. So you need growth in order to make sure that you have the right type of skills in the company. And as a consequence of this, of course, the ultimately, the value of the company is driven by the profits and dividends you are paying out. But of course, in short run, also the future expectations of the value in the company are very important driver of the fair value.
And that, of course, requires that you can continuously fund like R and D pipeline and build on that to create the future growth opportunities. So that's why growth has become important part of our agenda over the last few years. So maintaining high operating profit margins alone is not enough because that's not sustainable in long run without growth. And we decided, like Tim already explained, make the growth target a little bit more concrete. In reality, this growing faster than the market and this €1,500,000,000 by 2025, they are actually not that far away from each other.
So they pretty much are telling the same story, but we have realized both external and internally that giving a number, it's much, much more powerful message. It makes this whole target so much more concrete than what it used to be when we were talking about only growth percentages. So this gives €500,000,000 is very different than saying that we grow six percent a year. And just a reminder of this slide Tim already went through. So these are some of the ongoing actions we have had in the company to achieve the growth.
And there are many elements. One, for example, is that we are now spending money to achieve the growth. So this year's profitability without this growth initiative probably would be better. But of course, you cannot achieve the long term growth if you don't invest upfront. And also the sale of Orion Diagnostic was part of this growth study.
So reallocation of the resources from the business, which though was a good business and but was not growing that fast and was a little bit of isolated from the core of the company. So now we are working on using those assets we received by these divestments to generate growth in the core business areas. So what could be the ways to grow? I think it's good to know and say immediately that there is no one individual way of achieving the growth. That would, of course, include also very high risk if everything we are doing would be targeted only one way to grow.
But like Timo already said, it's clear that the robust good R and D work innovative new products that is probably the number one way how we are trying to achieve the growth. And of course, if daratumumab and the ALF program are complete successes, those alone might take us to very close at least to this €1,500,000,000 But at the same time, we, of course, know that world is not always proceeding as you would like to have, and that's why we also need, at the same time, different approaches, other ways to achieve growth. Another thing is that many of these are related. So if we really want to achieve growth, it also means that in longer run, we need to find a way to capture larger share of the value of our own innovative products than earlier. So as long as we are only taking like 20% royalty, it's very difficult to achieve long term top line growth.
But at the same time, if you want to get more than 20%, it means that we need to be prepared to fund the R and D programs internally more than we have done maybe in the past. Another thing is also that, of course, achieving this higher share requires that we need to also be prepared to capture probably a little bit larger share geographically of the sales than earlier. And there, of course, U. S. Is the key consideration because such a large part of all the new innovative product revenues are coming from The U.
S. Today, more than half of it typically. So we need to really think about that alternative as well. It's also good to have the own R and D, but of course, it would be also good, especially from the timing perspective, to be able to find also proprietary type of products for our sales organizations from outside. And of course, today, especially here in Europe, where we have a presence in almost every country.
But again, there is link to this earlier stage is that if we have a larger geographical presence, that probably increases the opportunities for us to in license good interesting molecules. So a lot of are linked to each other and the timing considerations here are very key. But at the same time, one is to remember that if we want to achieve this €1,500,000,000 it also means that we cannot see declines in the other existing legacy businesses. So we need to make sure that also they stay viable. And of course, we are trying to grow also the other businesses, even though the main focus from this €500,000,000 growth target probably comes from the proprietary side of the overall business concept.
And we are willing to make some focused investments, but I think at the same time, it's clear to say that the idea is not that the €500,000,000 growth is going to be achieved by one acquisition or merger. So it has to come from utilizing lots of these approaches at the same time. And hopefully, we find a way where they actually are supporting each other, like explained already earlier, more R and D funding, geographical expansion, more in licensing opportunities and so forth. But that's kind of the big picture of these ideas, which we are currently working through and which hopefully, gradually over the next few years, we can step by step tell more and more about. But also, one needs to think the ways to grow, fund all this growth.
And of course, one obvious way, which we already had discussed, for example, with this €30,000,000 investment this year is that you are investing on growth today, which of course means that the profits and the dividends today are not maximized, but more money is spent to achieve growth in long run. Partnering with big pharma, of course, has been one of the ways Aurion has been funding growth initiatives in the past. I will get back to the pluses and minuses of that approach. Divesting like the Orient Diagnostica divestment, that's one way, of course, to allocate resources to the growth initiatives. And then as an example of what is happening in the world, I put there also this finding new ways of financing.
So traditionally, you could raise equity or you could get bank debt or something like that. But today, the financial markets are evolving and we have been discussing over the years with some parties who are providing kind of a risk type of financing. So there are today organizations who are interested in funding R and D programs and accepting the fact that they will lose their money if the program fails. So far though, it has to be admitted that from the IFRS accounting point of view, it has been very difficult to make these work in such a way that they actually would generate the benefits we would like to see. But there are ways like that also today available more than earlier.
And then finally, of course, it's a reality that we need to make sure that the operations are run-in a good way. We make smart allocation decisions. We have a good cost discipline and so forth in order to make sure that from our existing operations as much as possible of the funding internally can be directed to these growth initiatives. So elements of partnering. That, of course, has been in the case of ORION one of the key ways of running our operations for many, many years.
Novartis earlier and now Bayer, of course, are the two prime examples of that. And there are a lot of elements, which actually in both of these cases are all present there. There, of course, are some differences. The main difference maybe between this Novartis and Bayer case has been that in case of Bayer, they have paid a major part of the Phase III program, while in the case of Novartis, Orient paid the Phase III program and was rewarded only after the fact. And as a consequence, in the case of Novartis deals, we got roughly one third of the market value.
In the case of Bayer, the royalty rate is about 20%. But both have milestone packages. In both cases, Orion has been manufacturing the goods and so forth. But if we think of this type of a partnering, of course, the big positive is that this partner is taking carrying the risk and funding the programs. They also have good global presence and strong commercialization capabilities.
And of course, especially taking into account this financial target of high EBIT percentage, of course, this approach generates very high operating profit margins because when you are getting royalties, which is basically almost 100 margin, of course, that poofies up the percentages of operating profit. Then on the other hand, fact is that, like in the case of Bayer, we get 20% only out of the absolute market value of the product. So it really limits our growth opportunities. And it also, when you are partnering out the molecules, it kind of limits your geographical expansion opportunities because you don't have the assets you could then sell yourself and which you could utilize to build on the next generation products. So there are certain limitations.
And of course, I mean, if you get the whole market value, even though you have to fund commercialization, assuming that you are capable of selling the product, also the absolute monies you are earning definitely would be larger. Then the second, coming to the cost side, the biggest cost item in our profit and loss statement is, of course, cost of goods sold. A couple of years ago, I showed the same type of slide about our supply chain growth or improvement initiatives, and this is just kind of an update. I guess that a couple of key messages here are that, first, you cannot in this triangle, you need to make sure that all of these elements are present there. So you cannot only cut costs if you if that has a negative impact on your quality or supply capabilities and also, of course, the other way around.
Especially in the generic side, you need to have a competitive cost structure in order to manage in the market. But there are no individual single answers to how to improve that. So it's a long list of all kinds of actions which we have been taking. And have these been successful? I would like to say, yes, they have been.
I mean, this picture shows that even though our business portfolio has become much more generic over the last five, six years, and also we have had fairly big hits from the price decreases in some of our key markets like the reference price products generics here in Finland, Parkinson's, Dexdoor. Our overall margin has still been relatively stable throughout all these years. And of course, it's partly also explained by the fact that the difference between the gross profits in our key business areas are not maybe as large as one would assume. So this just illustrates that, of course, the proprietary side is more making much higher gross profit, but not that dramatically as one might think. Then the second largest cost item is the sales, general and administrative costs.
And there, a couple of years back, I actually had the same slide in the previous Capital Markets Day. And there, we were able to show a continuously decreasing trend as a percentage of sales. Now there has been some changes and those mainly are due to the fact that we have, for example, here in Finland had the declining sales because of the price pressures, but also because we have started to invest for the longer term future. And that, of course, is most apparent in our European sales operations. So the as a percentage of sales, the cost of running the European sales operation are now somewhat higher than they were a few years back, but still at lower level than they were five, six years ago.
So I would like to say that we have a fairly good control on how we run our cost base. But at the same time, we have realized that we need to start now investing for the longer term future. And here, for example, the eSeeHaler investments are one way of doing that. But achieving growth, there are, of course, a lot of challenges in different areas. And here are some examples of how we try to manage these risks of targeting for the growth.
Of course, we all know that when the main way to grow is R and D, there are a lot of risks. And there are some ways, for example, I mean, we need to have broad enough R and D portfolio, but not too broad. I mean, I guess that's self evident. If you rely only on one or two programs and if those fail, you don't have anything. On the other hand, if you split your resources to two large portfolio of programs, you don't have enough resources to manage them.
Then we need to make have a very disciplined way of deciding that if we don't believe in a program or if we have better alternatives that we really make those decisions. And there, one example, for example, is now that recently we decided that we will not invest our own money further on the next generation COMT inhibition program, ODM-one 104, but rather target our internal resources to the oncology portfolio where we believe that we can generate more value in long run. And then, of course, partnering has always been a key way of managing this risk as well. Then timing, and here I'm especially referring to a little bit this fact that when you are investing for growth, it means that in short run, the profitability probably is not as high as it could be because you need to target and allocate resources to the growth initiatives. And here, we have some ways of mitigating.
One way, of course, from the dividend point of view is the fact that when we divested Jorion Diagnostica, we got a lot of retained earnings and also cash. And that was demonstrated already last year when the dividend for last year was more than 100%. But we need to take good care of our legacy business areas. They need to continue providing the cash flow and profit during this time frame. The cost discipline needs to be in good place.
But also, of course, when we have these growth initiatives, we really need to make certain that they are executed in the right way. And then, of course, ultimately, we need to be open to the markets. So the shareholders or potential shareholders, they need to be aware of what we are doing and why we are doing. And this is like today, it's one way of getting this done. And then if we think of opportunities, especially beyond our current existing key market areas, there are, of course, a lot of market risks.
And one way of managing that, of course, is that you enter the markets only when you have the right type of a portfolio available to sell there. If we think back fifteen, twenty years, we did in year of certain market entries where that probably was not in good enough shape and the outcome was not what we wanted it to be. We need to be flexible in the partnering. We need to also be flexible in the use of our own resources. And here, for example, using service providers during the start up phase is one way of doing that.
So you don't need to recruit immediately large number of Orion people if you enter a new country, but you can utilize contracts with contract sales forces and so forth. And then, of course, you really need to have good enough advance preparation before you do entries to new areas. So finally, kind of a summary of what I've been discussing here. The idea very much today is that if we want in long run to achieve all of our financial targets, the growth is really the driver also for achieving the other targets. And here are just as a summary some of the key ways of achieving this growth.
Of course, the execution of the R and D pipeline is really key. Geographical expansion probably is another one. But also, in addition to own programs, we really need to look at in licensing opportunities to complement the portfolio with ideas coming from outside of Orion. And like I said earlier, all these approaches support to some extent each other. It's easier to in license something if you have a broader territory to offer.
The steady development of existing businesses and then finally, of course, a good control of the existing operations, whether it's compliance, whether it's a cost of goods structures or any other costs. So if those are in place, achieving this good profitability should be quite possible. But of course, also it means that we need to be able to manage the complexity. As long continue having all of these different business areas, we really need to be very good in understanding how to run the total company and also very disciplined in how we decide to allocate resources to these different areas in the company. And if the profitability is good, the balance sheet very likely, especially as long as the main way of growing for us would is not planned to be acquisitions.
But of course, in addition to good profitability, we also need to make sure that our working capital structures are well managed and the CapEx is used in a wise way. And if all of these other three elements are in place, I think it's fairly easy to say that also the dividend stream probably should follow. But especially now in the coming few years, when we are investing for the growth, we also now have available this money from the ORION Diagnostica divestment to do a little bit of balancing of the short term profitability and then the fact that we try to maintain a steady dividend stream. So these were the prepared words from my part. So we have a lot of different growth initiatives ongoing and finding the right balance and timing between those is the key.
Well, good morning, everyone. My name is Christian Nordstedt, and I'm the Head of R and D here at Aurion, and I've been so for two years now. And in a couple of minutes, I will be joined here on the podium by my colleague, Professor Heikki Johansu, who will provide some more insights and in-depth information about our darolutamide molecule. Now R and D, the key engine for profitable growth. In the foreseeable future, we will have three main strategic goals for R and D.
First, of course, to deliver our late stage portfolio. But also, it is very tempting, of course, to move too much of our resources into the late stage portfolio. But what we also need to do is, of course, to build our early portfolio to ensure long term sustainability in our deliveries of new products to the market. But the third goal that is equally important, I would say, is to maximize the value of the assets that we have. And what do I mean by maximizing the value?
Of course, identify all these patients that can benefit from our molecules, from our products. We also would like to do the opposite, identify those patients that will not benefit from them and therefore, be avoided to use them when they don't bring any benefits to the patients. And then, of course, as Jari was talking about here earlier, try to take the molecule as far as possible into the development. If we decide to partner it at a certain stage, preferentially do it as late as possible in order to capture as much value as possible for it. Now in achieving more in R and D, one of our key strategic moves here is, of course, collaborations of various types.
Early on, we see that it's very, very important to generate collaborations with academic institutions. We are incredibly dependent on science coming out of academia, of course, but also establishing collaborations with smaller biotechs. I mean, we are very much aware of that Orion R and D represents a very small fraction of the global scientific community, and it's very it's necessary for us to expand and benefit from everything that is going on, on the globe. But also collaborations with bigger pharmas like, for example, Bayer in the darolutamide project, various hospital institution like us, who's been very, very important for us over the last years. We also have a more focused R and D now than what we have had in the past.
And in order to build long term growth in R and D, so we can help patients with their unmet medical needs, we have identified some key actions that we need to do. We need to increase the number of projects and not just increasing the actual number because that's very easy to do. We need to increase the number of what we believe is promising projects that actually can deliver this value to the patients. We have also well, during the first one hundred and two years of our existence, we've been a small molecule company only. But we realized, of course, that we also need to expand into other modalities, such as protein drugs and more specifically monoclonal antibodies.
And this is something that we actually have established within Orion by now, and I will tell you more about that later on. Building our strength in disease biology because if you want to address disease and treat it successfully, you, of course, need to understand the underlying mechanism so you can identify the right targets for your compounds. And then, of course, build a balanced portfolio with very novel targets that holds a lot of promise, but on the other hand, also carries a lot of risk. And that needs to be balanced with more established, or I would call robust targets. We've seen a lot of changes over the last couple of years or last two years, I would say, in our organization.
What we've done first is that we have restructured it from what I would call a process focus. Earlier on, we were separated into discovery, early development, later development. And now we have instead a structure that is based around the therapy areas that we have. We now have established our in house capability to discover protein drugs, primarily monoclonal antibodies. And we are also planning on expanding into more, what should I say, exotic and newer modalities that have perhaps not yet arrived, but we're pretty sure that will arrive in the not too distant future.
We made several key recruitments, both from here in Finland and people coming from abroad to join us from various parts on the globe. And what we also have done is that we have focused our two main R and D sites, Espoo and Turko. Previously, they were essentially each other's mirror images. But what we've done now is that we've said that Turco is our center for biotechnology and what we call translational research, which is more basic biology. And our site here in Espoo has taken more focus towards the chemical aspects of medicines, synthetic chemistry, pharmacy and so on and also clinical development.
Now what are our focus areas here in Orion R and D? Of course, it was central nervous system, medicines that built the modern Orion, and we are still very much committed to it. Oncology is emerging as a very, very exciting area for us now with darolutamide leading the way. And as you may know, oncology is coming out of our previous efforts in endocrinology. And that is something we're going to capitalize on, of course, but we're also going to expand into new aspects of oncology.
Respiratory, the ECALER franchise. There, we are not working with any new proprietary molecules, but we're trying to now to or want to use this device also for new generic molecules, new for us. Animal health is also a very exciting area. And there, we use our R and D for our proprietary human molecules to develop new medicine also for primarily companion animals. And then we have Fermion, which is our chemical production arm.
And what we're doing there is we're developing our active pharmaceutical ingredient for ORION's proprietary products. We're doing generic APIs, but we're also doing some contract development for other pharmaceutical companies. Now if we take a look at our clinical drug development programs, it looks like this today. And I will dig deeper into each and every one of them further on in the presentation. We have our EZHaler franchise.
As I mentioned before, there, we're doing the bioequivalence studies for tiotropium. We have the darolutamide, the Phase III programs that Heikki will talk a lot more about later on. We have ODM-one 109, which is oral formulations of levozimedan that we want to develop in ALS. ODM-two zero three and ODM-two zero seven are two oncology programs that we have decided to partner to out partner, and I will tell you a little more later on why we made that decision. And then finally, we have something unusual for Orion.
We have ODM-two zero eight and two zero nine, which are two entirely new molecules with a new mode of mechanism that is unique for Orion. And of course, they are chemically different from each other, but they have exactly the same mode of action. And what we're doing here is that we're actually progressing two molecules with the same mechanism in parallel in the clinic in patients. And I will tell you more about that also later on. But we're not restricting our work to do clinical development, of course.
We also have several earlier nonclinical projects under investigation. And that, of course, in order to ensure long term success in R and D. Now if we first take a look at our CNS therapy area, what we have done there is that we have stopped all our work in dementia because we think we're too far behind there and we cannot really be competitive in that area. Instead, what we've said is that we want to capitalize on our long experience in neurodegenerative movement disorders. And what that means in this case is Parkinson's disease, where we have a very long history, but also amyotrophic lateral sclerosis, ALS, and also chronic pain.
And currently, we are primarily working on symptomatic treatments in these areas. Now of course, we also would like to expand into what we call disease modifiers, which means a compound that actually slows down, so perhaps even halts the progress of these two diseases. But we even with success in this area, and nothing really exists for that currently, we believe that the need for symptomatic treatment is going to increase dramatically even after the arrival of such molecules for the very simple reasons that at least the first and second generations of these will not reverse the process, but will slow it down, which means that, of course, the need for new and better symptomatic treatments will increase quite dramatically. In Oncology, we are primarily working with what we call common cancer types, such as those steroid hormone dependent tumors, such as prostate cancer and estrogen receptor positive breast cancer. But we're also interested in expanding into more or rarer forms of cancer.
And you will hear more about that also later on. Then we have a new therapeutic area for us, which is rare or orphan diseases. This is still very small, and we are building it, but we're building it quite rapidly. Now orphan diseases, that's a group of more than 8,000 disorders, and this number is almost increasing almost on a daily basis. And of course, we need to focus there as well.
And what we have said that we would like to do is to focus on a group of genetic conditions called the Finnish heritage diseases. That's a group of 36 different diseases that is especially common in the Finnish population. But since Finland is a very tiny country, we have the majority of these patients, of course, living outside of Finland. But the great thing with doing this type of research in Finland is that the academic expertise, which we need absolutely need to collaborate with, you find the vast majority of them here at an arm length, here in Helsinki actually, but also in Co Opio and other parts of Finland. We have access to the patients.
And of course, there's a lot of commitment among our scientists for this class of diseases. As I said, it's 36 of them. We cannot do all of them. So we have decided to focus on a smaller group, primarily with in the central nervous system, where we can also see synergies with our CNS therapy area. Now balancing an R and D portfolio, that's a very, very challenging task.
You have on the x axis the commercial potential of a project. And on the y axis, you have the probability for technical success. And what you, of course, want to do at any cost is to avoid the lower left hand part of this graph here, low commercial potential with low probability of technical success. But what you instead want to do is to end up in what we call the sweet spot here, where you have a high probability of technical success and high commercial potential. And what usually happens during the progress of a project is that you're starting further down here in the probability of technical success.
And then by learning more and more about what you're doing, you can increase your chances and up in the area you would like to be. And I think we will hear more of an example of such a project that have evolved into this sweet spot. And I would like to ask my colleague here, Professor Heikki to join here on the podium and tell you more about that.
Thank you, Christa. And now it's my pleasure to talk about ektarolutamide, something that I consider very exciting. So my name is Helk Joensu, and I have been working at Aurion for about one point five years. And before that, I was an oncologist working at the Helsinki University Hospital and also as a professor of oncology at the Helsinki University. I'm going to talk about darolutamide.
And actually, I remember darolutamide from my days at the hospital where I treated a few patients with prostate cancer with this drug within the clinical trial. And as I remember, darolutamide, it was effective, but it was also extremely well tolerated by the patients. So they complained virtually no side effects. And I'm very glad that these observations have now been verified in a large randomized trial. So let's move on to darolutamide.
I'm going to talk about some scientific details here. If you if there's something that is not clear to you, please do not hesitate to ask. I'll try to explain. So darolutamide, it was invented at Orion and developed by scientists working at Orion. Orion partnered darolutamide with Bayer to carry out the late clinical stage of development together with Bayer.
Darolutamide is called a second generation antiandrogen. This means that it blocks the signaling of the androgen receptor that mediates the effects of the male sex hormones in the body. A point that I want to make here is that darolutamide is a unique drug. The other second generation antiandrogens, enzalutamide and apalutamide, have structures with only subtle differences, as shown on this diagram, whereas dorolodamide, as you can see, is very different from these two other molecules. The distinct structure of darolodomide results in properties that may be important to the patient.
For example, the data we have suggests that darolodomide has few drug drug interactions, and this is important for those patients who need to take many medications. Darolodomide concentrations in the central nervous system remained low, which helps keeping the frequency of central nervous system related side effects low. Two large randomized placebo controlled Phase III trials with more than 1,000 patients in each are now evaluating darolutamide. The Aramis trial and the Ara SENSE trial. The Aramis target population are men with localized prostate cancer that no longer respond to conventional hormonal treatments and whose blood prostate specific antigen levels increased despite of standard treatments.
The target population of the ARA SENSE trial are men who have overt metastases from prostate cancer detected, for example, by computed tomography and who have not received conventional hormonal treatments. We expect to see the or get the Arasens trial results in about three years from now, but we now already have the first results from the Aramis trial. And I'll now move on to the main result of this study. And here, you can see a survival curve of the primary endpoint in the Aramis trial, which was metastasis free survival. And by metastasis free survival, we mean the time period from the date of randomization to the date of first detection of distant metastasis.
And as you can see from this graph, darolutamide clearly improved metastases survival in these patients. So the upper curve is darolutamide and the lower curve is placebo, the control group. And you see some space between these curves, and that is measured something we call a hazard ratio. If the hazard ratio is smaller than one, that's good. And when it gets lower than 0.5, that's very, very good.
And we do not get that kind of hazard ratios with most cancer drugs we actually have in oncology. But this is a very good result showing significant efficacy for darolodamide. So the metastasis free survival improved from eighteen months to forty months with daroledamide, about two years. And that's, in my opinion, very significant for the patients. But what is even more significant to the patients is, of course, survival.
How long will I live if I get this type of prostate cancer that progresses despite conventional hormonal treatments? So that's called overall survival. And overall survival means the time from the date of randomization to the date of death or to the date of last follow-up visit if the patient is still alive. And this is the analysis of the overall survival. It also favored the darolutamide group.
So the darolutamide curve is running on top of the placebo And you can see the P value of 0.045. So traditionally,
that
is considered significant by a statistician. All p values that are smaller than 0.05 are considered significant. But in this case, we cannot claim statistical significance because of the design of the study. Overall survival will be analyzed twice and not once, and therefore, the p value required is smaller than the traditional 0.05. But there's a strong trend, as you can see, for better survival, longer survival for patients who receive daroledomide.
The second analysis for overall survival is still pending. Well, these results were recently published in the New England Journal of Medicine, which is probably the most highly valued medical journal there is, that accepts only a small fraction of the manuscript offered to the journal for publication. We suspect that the Aramis results were accepted in New England Journal of Medicine due to the substantial efficacy we saw with darolutamide that parallel start of enzalutamide and arpalutamide and, in particular, due to the excellent safety profile of darolutamide that resembled placebo. The only side effect that occurred in more than ten percent of the patients was fatigue, twelve percent in the daratumumab arm and nine percent in the placebo group. The discontinuation rate was similar in both arms, nine percent.
And as predicted from the preclinical data, there was no increase in central nervous system related side effects such as dizziness and cognitive disorders. And we detected no increase in several other important side effects such as falls or fractures or skin rash. The FDA recently granted a priority review for darolutamide. This supports our view that darolutamide has properties that will benefit prostate cancer patients despite enzalutamide and alpalutamide already on the market. Taken together, we believe that daroledomide is unique, new agent for the treatment of prostate cancer, which is the most common male cancer in many countries, including Finland, Western Europe, United States and second only to lung cancer globally.
And it has a high efficacy and an excellent safety profile. Thank you.
Thank you, Heikki. So now let's continue with oral levozimedan or that we call ODM-one hundred nine and the ongoing Phase III trial in ALS. Now as you may know, levosimedan is an older Orion compound that is used for cardiac failure. So you can ask, of course, why use cardiac drug for ALS? Well, it's all due to the mode of mechanism of this molecule because what it's doing is actually through interacting with certain proteins in the muscle fibers, it makes the muscle fibers stronger.
And what happens in ALS is that it's a neurodegenerative process leading to lack of control of progressive lack of control of muscles. And that, in turn, leads to paralysis. And usually, what happens is that the patient dies within three to five years after diagnosis due to respiratory failure. And what we would like to achieve now with this molecule is to increase the strength of those motor units, as they are called, the nerve connected to the muscle fiber that still remain and help the patients, especially with the respiratory function. And now we have an ongoing RHEFALS Phase III trial that we're doing entirely on our own.
And well, it was started almost a year ago from now, and it's progressing as planned. And what is important to point out also is that this is not only based upon a hypothesis of strengthening the remaining motor units, but we actually have Phase II data pointing in that direction, the Levels Phase II study, where we could show that with the treatment with one to two milligrams of this compound, we could see a significant change in what is called super and slow vital capacity. Unfortunately, that study was too short to assess changes in overall function of these patients, but it strongly points in the direction that this could be beneficial to the patient's respiratory function. And considering the lack of alternative for these patients, we also felt that we were obliged to test these findings in a bigger, more informative study. So the objective to demonstrate the benefit on respiratory and overall function in ALS and also to study the safety in the prolonged study in ALS patients.
And now well, it's Phase III, four fifty patients randomized two:one. And what we're doing is that we're studying it over forty eight weeks. And then, of course, with an optional long term extension study at the end of these forty eight weeks. And the primary endpoints here is supine flow vital capacity at twelve weeks. And then we also have these secondary endpoints.
It's a global study. United States having 48 of our the total of 104 ALS centers. But then we're also performing the study in numerous other countries as well. As I said, recruitment into this study is going really well. We see very low dropout rates as well.
And we hope to have the last patient visit in July and the study results during the second half of twenty twenty. I mentioned early that I personally am very excited over this, what we call, CYP11A1 platform. And I will tell you a little about why I'm so excited. CYP11A1 is an enzyme that catalyzes the first step in the formation of steroid hormone. And it's unique in a way in that there is no redundancy in this system, meaning that if you inhibit this enzyme, there is no other enzyme that can take over or help.
So if you're successful in inhibiting CYP11A1, you will wipe out steroid production completely. And this is a mechanism where we seem to be alone to the best of my knowledge. We're certainly ahead of the pack here. And well, we've been able to show in animal experiments, of course, that indeed the molecule is doing or the molecules, I should say, are doing what they are supposed to be doing, and that is to totally eradicate steroid
production
in the body. Of course, what you need to do then is that you need to supplement the well, the animals and also the people that you're treating with glucocorticoids and mineralocorticoids because they are necessary for life for obvious reasons. But there are numerous other steroid hormones as well, testosterone, the male sex hormone and estrogen. And that is the basis why we believe that we have a mechanism that can work in several types of cancers. Prostate cancer, one point three million cases per year, the second most common in males in the world seventy percent of all breast cancer, meaning what we call the estrogen receptor positive breast cancer, those that are dependent on estrogen for the growth.
But there are also some less common cancers such as endometrial cancer of the uterus, where we have about zero point four million cases, adrenal carcinoma, which is very, very rare. Here in Finland, we have about five cases per year. But still, it's a very important cancer, very severe form. And also some hormone producing benign tumors. And as I said, what we're doing here is that we are progressing two molecules in parallel or somewhat staggered in human Phase onetwo trials.
And the reason why we're doing that is not that we have encountered any issues with the first molecule, but simply knowing that small molecule drugs can have surprises. I mean, we know that it's usually candidate number three, four or five that eventually becomes a product. And we have a leading position here, and we want to make sure that we maintain that position, and that's why we decided to do that. In the first trial that started up in March, we are only studying prostate cancer. And these are more severe form of the cancer patients that are progressing in spite of novel hormonal therapy and chemotherapy.
And here, we are doing the study in Finland, France and in The UK. The more recent study, Stasidas, that opened up for patient enrollment in April, that is what we call a basket trial because here we're studying not only patients with, what I could call, treatment resistant prostate cancer, but also breast cancer patients that have progressed in spite of two or more systemic treatments. I would also like to give you an update on two other oncology molecules, ODM-two zero three and ODM-two zero seven. And as I mentioned earlier on in the presentation, these are these two molecules we have decided to partner with outside companies, and these are ongoing activities. Two zero three is, as you may know, a tyrosine kinase inhibitor that inhibits fibroblast growth factor and vascular endothelial growth factors.
And there, we have the Keydas Phase one to two trial Phase one to two trial with 84 patients altogether. And we have seen some encouraging results. Nine percent of the patients have responded and forty four percent have seen a disease stabilization. And that means that we have a clinical benefit rate of fifty two percent and also mostly mild side effects. ODM-two zero seven is a BET inhibitor, quite a crowded area.
And what that is doing is that it indirectly inhibits key oncogen such as MYC. Also there, we've seen a molecule that has been generally well tolerated, and we have ongoing partnering activities. But as I said early in the presentation, we need to focus and focus our resources on these projects that we strongly believe in. And therefore, we have decided to deprioritize these two compounds or these two projects. E Z inhaler franchise, that's an important growth area for Orion as well.
And we are continuing investing in this franchise, of course. And what we want to achieve here now is to develop Tyotropium for ECHELER. Tyotropium is, as you may know, used for the treatment of chronic obstructive pulmonary disease. And what we're doing here is the bioequivalent studies that is necessary for its registrations. And of course, here, we've been able to benefit from our previous studies with other compounds, and that is helping us to progress this as rapid as possible.
We also would like to take our ESA Halo into the twenty first century by producing an addition to the device that we call the connected eSiHaler. And that is that we would like these eSiHalers to be able to communicate with the patients and with the caregivers. And what we're doing here is that we've developed an electronic device that will be physically attached to the eSeeHaler. And this one this device will communicate with the patient's smartphone, and the smartphone will communicate with the caregivers and the health care professionals. And by doing that, we hope that we will be able to increase treatment adherence.
We will strengthen the patient physician relationship and, of course, hopefully also reduce hospitalizations leading to an overall benefit for the patients, disease control and quality of life. So my last slide here, Orion's R and D vision for future success. We believe that we have a company with the brainpower and the muscle of a large company, but also the agility of a small biotech. I strongly believe that we have a balanced pipeline that can deliver what we call clinically meaningful differentiation over a prolonged period of time with lots of exciting things happening now in the immediate and more medium term. We would like to be a preferred partner for other pharma companies, biotechs and academic institutions.
We believe it's absolutely necessary to have the capability to deliver small proprietary molecule drugs, but also new modalities such as biologics. An increased visibility in the academic community is important for many reasons, including our ability to recruit the best and the brightest from academia, but also to establish exciting collaborations. And of course, we don't only want to be a benefiter of what the global scientific community is producing, but we also want to be a significant contributor to it.
Thank you, Tukka. Good morning, everybody. It's my great pleasure to share you some of the highlights about the proprietary business and discuss about some market prospects as well. So before I go to the businesses, I sorry, it's this one. I'd like to tell you a few words about the operation.
So I'm heading the commercial operation, And it is actually two units which were put together six months ago, the sales operation and then the proprietary business. And although the colleagues in the proprietary products, they had done a great job there, But now we thought that if we combine these two units, so maybe we could find some synergies, which we could then utilize for the benefits of the Orion. So first of all, there is this sales operation, so which sells specialty products, that means generics, OTC and biologicals. And then also, we sell proprietary products in 26 countries. So we have operations in 26 countries.
And then outside Europe, as you know, we operate via partners. So then, of course, the proprietary business and the three sub businesses, it's an important element of this unit. I will talk about those businesses later. And then the global market and brand marketing and brand building since, of course, we create our brands for European level and then also in the future, hopefully, for global avenues. So and market access and business support, that's also a very important part of this operation since all the businesses at Orient are looking for growth.
So Thermion, animal health, specialty products and proprietary products. So this unit here serves all of these different businesses to help them to analyze the markets and think about the market access, to do that. So that's why it's so important. So then talking about these businesses. And here, of course, I echo very much what my colleague, Christa, just explained about the R and D and Orion's therapeutic areas.
So of course, our businesses, they are very much linked there. So we are active in the CNS business. And for us, it mainly means Parkinson's disease, ALS and pain management. In Oncology and Hospital Care, you might remember this was earlier called Oncology and Critical Care since we have there our critical care products, Cymdax and Dexter. And we are still, of course, looking for critical care, but now we want to expand a little bit our focus to cover the whole hospital customer and look for opportunities there, which could support our current portfolios and which we could utilize our current hospital sales force.
And in oncology, of course, the prostate care and other hormonal cancers are in our focus. Easyhaler business, we nowadays call Easyhaler and Respiratory business, since although this EZHELE franchise is so vital and important for us, and we expect big growth there in the future. But we would like to look for other opportunities, product opportunities also for these respiratory conditions. So the beginning of this year, it was kind of a new era for proprietary business. For several years, entacapone family, the Parkinson's disease products, they had been in the number one position.
But now it's a new era, and Easyheller family is our best sold product line. And of course, there was a great growth last year, and these are the MAT March figures. And then there is the decline in Parkinson's products as well. And Dexdau, which is now facing the generic competition, there was the it was the same level than in 2017. But of course, this year, we have been seeing more and more competition in more countries.
And SIMDUXA, our old warhorse, is still delivering growth, which we are very delighted about. And the Precedex is actually the same product than Dextor, but we are selling our partners are selling that outside Europe. So now we are living in the era of Easyhaler. And when thinking about the proprietary products and the growth opportunities, what we are having there in coming five, six years, so I would categorize them to four different areas. So first of all, we have our existing portfolio.
As said, we still have lots of room to grow and improve there in E Z HAILER and SIMDUX, especially. Then there are a bunch of these R and D projects with Christer shared. So of course, the most prospect, the picky prospect we have in darolutamide, both indications there, ODM-one hundred and nine and thiotropium. And then there is this list of other compounds as well. So it's important that we have a very rich pipeline there as well.
Then in licensing and product acquisition area, we are our teams are really working very hard to look for new opportunities and going through multiple cases there, And mainly those new ideas or initiatives, they are focusing on these five areas: Parkinson's disease, ALS, pain, cancers and respiratory. And then I think that there's no pharma company who can do everything by themselves. So they are in different kind of collaborations, so is ORION as well. So we have these research collaborations together with companies and universities, and that's, of course, long term. Then we are in co promotion deals with arrangements like with Bayer, for instance.
And then these digital projects, which are becoming more and more interesting and important. So there, we also cooperate with multiple companies in areas where we are otherwise also active. Then a few words about the CNS business. So this is the business, as you know, Orion has been in the many decades already, and aging population is certainly one of the drivers here. CNS consists of many progressive diseases.
And unfortunately, there is not usually, there is no cure to those diseases. So that makes it very challenging area. But on the other way other hand, also very rewarding area, both scientifically and economically said. The Parkinson's disease, it's a progressive nervous system disorder that affects the movement. And there is about seven million Parkinson's disease patients in the world, and about one hundred thousand people die in Parkinson's disease every year.
It is an interesting market, about $3,300,000,000 And I truly believe that it is even increasing, the size is increasing due to this aging population, but hopefully also through new innovative treatments what companies will develop to the patients. Orion has a very broad knowledge about Parkinson's disease through our STALIVO and COMTAN products, and we are widely known by the patients but also the treating doctors. So that is something we want to build on. And I think that the very good signal of that wish and aim is this repatriation of Stalivo and Comtan from Novartis in Europe. So this is the area we want to be also in the future, and we definitely look opportunities there.
So our commitment is to expand the current portfolio for Parkinson's disease patients. Medication is, of course, the main thing in treating the Parkinson's disease patient, but also we have to they have a holistic view to this patient. And there are other areas as well, which have a huge impact to quality of life of the PD patients. So there is nutrition, sleep and physical exercise. So our vision is to develop this kind of global solution for these patients, which is personalized and data driven to manage this Parkinson's disease.
So it will be device independent. So you can combine it to whatever phone or computer or any other gadget. And so it would collect the real life data of these Parkinson's disease patients. And then it would make these visits to doctor between the patient and the doctor more efficient when you have the records about what has happened during the last weeks. And also, that facilitates the connection between the doctor and patient between the visits.
And of course, the ultimate goal here is to increase the on time daily on time for these Parkinson's disease patients, which is very vital. Then I move on to ALS, also the disease which Christa here covered very well. So this really, this devastating disease, which is leading to death due to respiratory failure in approximately three to five years. Of course, there are also patients who live longer, but this is kind of the average. And it is a market of about 60,000 patients, and we are now considered the major market here.
It's usually hitting the a little bit patient or people over fifty years or so. And there is a huge unmet need there since there is no proper cure. And we truly think that if the Phase III results are then as what we are expecting, so this ODM-one hundred and nine could be really a solution and not well, at least it could offer a solution to this respiratory function for these ALS patients. This is the size of the ALS market. It's about EUR €330,000,000,000 market last year, and it is expected to be four times bigger in less than ten years' time.
There are a couple of products already on the market, but mainly this market will become bigger due to these new treatments. And one of them, hopefully, will be ODM-one hundred and nine. There is currently lots of research activity in this area. So there is about 50 molecules under development. Mainly, they are in preclinical stage, and none of them is as advanced level as ORION compound here.
So but that's good that there is so much activity because then the knowledge about this disease, it will increase all the time. And that will, of course, benefit all the ALS patients. So really, this is will be an interesting treatment option for the patients. The results are expected second half of the twenty twenty. And we are currently evaluating the commercial structure in The U.
S. And Europe. As said many times, this is an orphan drug disease. So it means that there is relatively small amount of patients and then also treating doctors. So for instance, if you take U.
S, there is about 100 clinics, which treat these ALS patients. And then 80% of these clinics are actually located in 22 states. So that just gives you a little bit the magnitude about these the treating doctors in The U. S. And what's also interesting that these clinics are very much there is overlapping between ALS and Parkinson's disease.
So there is a clear synergy there. In Europe, in these big five countries, there is six thousand to seven thousand patients in each of the country, and these patients are treated in university and big central hospitals. Then I move on to Oncology and Hospital Care. So as said, we have this our old brands, Dextor for ICU sedation and Cymdax for acute heart failure. So they are still there in our portfolio, and we continue to work around those products.
But of course, the oncology, as it's important in our R and D, it's the future where we want to go also in the business. So talking about these hormonal cancers. So there is listed all the cancers that out of those hormonal cancers represent about more than twenty percent of all cancers. And as said, this ORION interest is in breast, prostate and uterus cancer, among others. So our aspiration is really to become an oncology house in prostate and also in this in home around dependent cancers.
And if you look at the market, so there is definitely a lot of potential. So the prostate cancer is the second biggest market market second most common cancer in men, and there is more than one point two million cases annually. Usually, the prostate cancer hits the men at age of 50, but I suppose the average age when you get prostate cancer is 65, 69. However, that means that those men are still in a very active phase. So they are in work, they have families, friends, hobbies.
So therefore, it's important that treatment that it is effective, but also that it has a safety profile, which is well tolerated. The market is big. It was last year about US8.5 billion dollars and it is expected to about double in ten years' time. 60% of this market is covered by U. S.
And it is dominated by the next generation anti intrachains like Apera Torreon and Enza Luta mine. Apera Torreon sold last year more than EUR 3,000,000,000, but it had the patent expired last quarter in U. S, and they faced generic competition, which, of course, had an impact to the price levels. Enceladolutamide have been on the market from 2012, and which I just need to check. So it was the they have the both indications.
So nowadays, they have both metastatic and nonmetastatic indication. So although darolutamide is not yet on the market, so it is still in the registration, but I still I dare to say that it has really it's tolerable, it's efficacious, but it's also tolerable. And the profile is there's no difference to placebo. And that's, of course, very rare in when you think about the cancer products. So we have big hopes for this product.
So The U. S. Launch is expected this year and Europe and Japan to follow next year. And we will co promote this together with Payer in 16 countries in Europe. This has a huge potential.
So according to Payer, they see their in market peak sales potential more than EUR €1,000,000,000 And we will get then the 20 royalty and then, of course, also some one off payments depending on the certain sales targets. Then last but not least, I'd like to talk about our Easyheller family. So Oriano started in this business more than thirty years ago, and the first product was launched in 1993. It was EZHELE salputamol. And nowadays, we have the world's largest franchise with six different products.
So this is a busy picture, but I just want to highlight here two things. So big market potential, so USD $2,500,000,000 when we look at the top five countries, and they actually represent about 70% of the European market. And in this market, the biggest share is covered by these so called LAPA ICEs, so long acting PET agonist and inhaled corticosteroid, the combination product. So it is the big share there. And also in it's big amount of share of the business today, and it will be also in 2027.
And we have there the combination products. We have also mono products, which is this 6% share. So I think that we are in right segments. Then there is the COPD market, equally big market. And also here, Orion is in this 27% segment, which is the combination product.
And then the thiotropium, it would fit into this 18% segment. So again, I think that we are in the right segments there. So then when talking about the eSeeheller, you, of course, always have to talk about the device as well. And in the one of the challenges in respiratory and asthma and COPD treatment is adherence to the treatment. And therefore, it's very important that the device is as such that the patient is very willing to use it.
And that's why we have studied this topic also a little bit. We have run some of the market research, and we have really given these asthma COPD patients, we have given them a try a different kind of devices, hold them, and we videotape those interviews and really try to learn that what are the things what patients want to have the things what they expect from the device. And one of them was really easy to use. And then it has to be the size that fits to your pocket or your purse very well. It should have the dose counter, inhaled cap.
And then the design should be at least somehow that it is you like to look at it or that you dare to put it on the table. And Easyhelid as a device actually did quite well in this market research. So we were very pleased about the results. Of course, however, we always we want to see if there are any needs to develop the device further, and we have to be alert there as well. And really, the key benefits of this Easyheller is that it has a full portfolio in only one device.
It's easy to learn, easy to teach. So it's very important for the doctors because that saves time when they have these patients coming over. So it's important factor. Accurate dosing and very robust device. And then as said, this patient satisfaction, it improves the adherence to this treatment.
So this digital project, they are, as said, very interesting area, very important to the patients as well. And as Christaer explained, our connected eSiHaler, so this is really something what we are very enthusiastic about, and we will follow what kind of input we will get from our patients. And then, of course, this is now the early steps. And in the future, we will also develop it further and add their other characteristics as well. So as said, Proprietary Products business is really we are ready for growth.
We are very enthusiastic about the different projects we have internally. So these new innovations, what we will get through our own R and D, we will definitely would like to commercialize them ourselves. We enhanced our in licensing activities to find these products to be launched and benefit our current businesses. We have the European wide sales force to take over products. And then also this current portfolio, as said, it is still really offering lots of growth opportunities and potential, which we want to exploit fully.
Thank
you. Thank you, Sattu. And it's great to have an opportunity to also introduce Specialty Products business. We have a little bit different kind of dynamics in this business, and I will briefly tell you the key facts from the Specialty Products business point of view. I will review the market situation and then I will tell what are the strategic actions, how we are in Specialty Products business going to support growth initiatives of Orion.
So the Specialty Products business is the biggest business in Orion at the moment, and our key market area is Nordic. And our value proposal and value promise for the health care professionals and also for the patients is that we will provide a very wide product portfolio of affordable generic drugs for them. And also, we like to give an access to biological treatments. Then we also have a promise for the consumers and patients to support the healthier lifestyles. And we also provide very wide product portfolio, especially here in Finland, OTC products, which are medicinals and non medicinals.
So we see that we have extremely important role in this health care sector in especially here in the Nordic market. We are keeping these promises by providing products with three different business lines. We have products for the generic portfolio, where we have substitutable generic products and also branded generics. Then we have also OTC products with medicinal products and non medicinal products, and we are also having a small portfolio of biosimilar products. If you look at the history of the Specialty Products business, we have a long history within the company, and it's a very nice development during the ten years ten past years.
We have managed to develop this business from €240,000,000 up to almost up to €500,000,000 business. During the last year, there has been a slightly drop because of the market dynamics and changes, especially here in Finland. There are several factors behind this development of this business. First of all, we have continuously managed to develop our product portfolio, always introducing new products for the society and for the patients. We have, all the time, managed to optimize the value chain and also increase the efficiency of our sales operations.
If you look at this business from regional point of view, Finland is our main market area and also Scandinavia is important for us. So totally, Nordic is presenting 73% of our net sales. We are also present in Eastern Europe, especially in Poland, and Russia is also a growth area for us. Then we have also 13% of the sales coming from other areas, and we are utilizing there also business to business opportunities. The biggest business comes from the generic drugs and the growth comes from the generic drugs and then 24% is from the self care products and biosimilars are quite small part of the business at the moment.
If you look at the global trends and how do we see the generic market development in general, we see that there is the trend is positive and there is really need for the generic products also in the future. As we know, there is a very high pressure to decrease the cost of the health care and medicines and really the generic products are the response for that need. There is an aging population and all the time need for the additional volumes and additional needs by customers and patients. And also, we see that the penetration of the generic products in country level, there is still opportunities. Totally, the global generic market is estimated to grow 7%.
And in our key market area in Nordic, the growth rates are also quite nicely increasing from 2.5% to 5%. And the estimated growth for Poland is 7%, so that market is also developing more and more to the generic markets. So there is a need for the generics also in the future. But one, in a way, change in this area and this market trend is that the growth is really coming the next double digit growth is coming from the biosimilars. So in Europe, the biosimilars growth opportunity has been estimated to be 25%.
And biosimilars are a big opportunity for the industry and for the patients and also for the society. Totally, 70% of biosimilar markets are from Europe, and the growth rate is 25%. There is some strength and also some weaknesses within this industry. If you think about the benefits of the biosimilars, there is cheaper opportunities to do R and D, have a better access for the biological products to the patients. And also the weaknesses of these opportunities is that they require high investment levels.
And what we have seen within this industry and with the biosimilars, it's extremely dynamic market environment, especially here in Nordic. But great opportunity and it's so important that there's a sustainability within this biosimilar industry also in the future. And many stakeholders have important role there. How we are then proceeding with generic business in European level and in Finland. Here, you can see the main market areas.
First of all, the generic markets are very complex markets, and there are several similarities and differences already in the Nordic countries. Differences comes from the pricing of the different countries and also the tendering processes in hospital sales. And that brings a lot of complexity in the market and a lot of dynamics and competition situation is very, very strong there. So you really need to have a good understanding of the market dynamics, have flexible operations in place. If you think about Finland, in Finland, the market had decreased 7%.
We are number one company there, and I will go a little bit further with the details briefly. And also in the Scandinavian countries, we are among the top 10 generic companies. And of course, we want to improve our situation there and be in a better position also in the future. In Poland, the growth is nice, three percentage, and our ranking with the generics is number 20 at the moment. Finland is our biggest market area and Specialty Products, a part of that business is very, very big and majority of the businesses from Finland is coming from Specialty Products business.
Total lithium market value is EUR 3,000,000,000 almost EUR 3,000,000,000 market and our market share there with the reference price prescription drugs is 26%. And we have managed to keep that market share in this demanding market situation. With the self care products, our market share is 25%, and there has been a slight decrease compared to the earlier situation. The biggest product portfolio is for us is the reference price prescription drugs. There, we have seen that the market has declined and about seven percentage last year, and our position has there been also declined.
So our market development has been 9%. But of course, we have a very wide portfolio and that has an effect to our market position, but we see that we have been managed to keep it very well and we have a lot of different kind of plans and opportunities to improve our share there. Just to summarize the opportunities and challenges in the market. Finland, we see that the price competition is going to continue, and we see that the pipeline of the generic drugs is going to be from the small molecule products to the large molecule products in the future, but there is also a lot of opportunities in these markets. And we see that we have great opportunities with the continuous renewal of the product portfolio.
We have plans to restructure our product portfolio, and I will share a little bit our ideas and actions in that area. Then it's extremely important we also start to look more and more the new market entry opportunities within this business. Also, one key market trend in this generic environment is that the management of the supply chain is becoming more and more important. We are really working within the global supply chain. We are sourcing and delivering products to global supply chains.
Then I will a little bit open to complexity and competence aspects from this business from the specialty business point of view. First of all, we have a very wide product portfolio in place, and that's advantage for us. And you really need to have a competitive product portfolio in place. If you look at the biggest products in Specialty Products business, the top 10 products generate about 30% of the total sales. And we have a different kind of products there.
We have generic products, biosimilars and OTC. So the product portfolio is very balanced. And we all the time do the constant flow of the new product launches. So for example, last year, did totally 65 different launch activities within this portfolio. Totally, we have 2,500 MAs available, and that brings us to the 3,200 SKUs.
And when you have this kind of wide product portfolio and you really need to have be competitive with the cost of goods, it's extremely important that you manage the value chain extremely efficient way and have a different kind of tools and business models in use.
Then
one dimension with this generic business is the supply chain management. It's very important that we meet four different requirements when we are managing these global supply chains. Compliance is extremely important. It's not only the compliance of aspects and product quality, it's more and more also environmental health and safety aspects, what we are managing throughout the global supply chains. The sustainability is coming more and more important in this area.
And for example, we, as a company, are a member of Pharmaceutical Supply Chain Initiatives Forum, where we have an opportunity to all the time benchmark and improve activities in the sustainability area. And we are putting a lot of effort for that and doing a lot of activities within this area. Service level is very important for us. And for example, if you think about this industry, it's we have several times that kind of issues and challenges that the market itself, for example, for APIs and intermediates is very fragmented for the there's only a few companies which provide APIs for the open markets. And if there is any issues, that will have an effect to the whole supply chain.
Also, only regional effects, but also it can have a global effect. So it's very important that there is all the time end to end supply chain management in place. Productivity is extremely important. Like we discussed, how much the gross profit has been managed to develop also in generic product portfolio. It's important that we have productivity improvements ongoing throughout the value chain every day.
We need to have improvements there in place. How we are then in the Specialty Products business going to support Orion's growth initiatives. In the Generic business, we like to and we will strengthen our position in Finland, and we always like to have the optimized synergies with Nordic with our portfolio. This really requires continuous development of the generic product portfolio. There, have different opportunities in our hand and different tools.
We are actively doing in licensing. We are also starting to do more and more generic development to have more added value adding generics in our portfolio. And we are also evaluating portfolio acquisitions and brand acquisitions in this area. We evaluate all the time expansions to the new market. If we have competitive product portfolio available, then we have opportunities to expand also outside the Nordic.
And then we are utilizing both licensing opportunities by business to business sales and through the partners globally. And we are also evaluating all the time opportunities to do collaboration with other generic companies. With the biosimilars, our vision and our plans are to be the Nordic commercialization partner for biosimilars. We like to offer for our key stakeholders and key patients also access to the biosimilar and biological treatments. And here, strategy is that we are not investing to the value chain.
We invest we are the partner for the commercialization, and we like to have extremely competitive product portfolio in place by partnerships. And we also have started to evaluate opportunities to enter to the markets outside The Nordic. Then within the OTC business, we are doing changes in our ways of operate to come from the product driven company more to customer driven company. So we are fine tuning and improving our RO portfolio to be more customer centricity. Then with this area, we have the biggest portfolio in Finland, but we are also evaluating focused investments to the brands in different areas.
And the areas where we are evaluating these are the Scandinavian, Poland and Russia. And this gives also us an opportunity to grow this OTC business. And of course, also in this area, we are very open for the collaboration opportunities. In big picture, our role within this company is to make sure that there is a solid profitability, which enables Orion's growth initiatives. As a business, we have a target to grow faster than markets, and we are ready to do and we are doing all the time focused investments to the areas which I presented.
These are the main elements how we, in Specialty Products, are going to support Orion's growth initiatives.
Thank you, Wirwe. Now it is a good time to give maybe some key takeaways, some of the summaries, what has been discussed throughout the morning. And the way the company is now prepared to grow, really the growth drivers as we've seen from the business perspective, that is certainly the proprietary products that is fuel is provided by R and D, both the captive R and D as well as the in licensing opportunity. Also, that then gives provides the opportunity for the expansion of our commercial footprint should we choose to do that. And clearly, as already mentioned, one of the key opportunities would be obviously The U.
S, but not necessarily the only one option that we could have to expand our commercial footprint. So focusing on both investments in proprietary per site, especially the product, getting new products, but then also appreciating that putting those products to the availability of patients that becomes one of the key growth drivers for the company moving forward. Now, the Specialty Products has a very important and special role within the business portfolio of Orion. The focused investments in that business, certainly, we will see and continue to see that in attracting new business, be that again in products, be that in selected entries into new markets. But the backbone of that business is to sustain its good cash generation property, keeping the profitability up and then supporting your growth by driving that business.
And we've seen that volatility that relates to that business. One of the aspects is certainly the biosimilar tendering. However, what we've also indicated in the past that, that provides a lot of volume, but the margins in that business have eroded. So the impact of that to the EBIT line is relatively modest. Now, the animal health is a very interesting part of the business.
Our focus there are companion animals, feline and a canine. When we look at all the opportunities that we develop in the human side, and there are actually quite numerous trials that we are running currently. And hopefully, those will make into the marketplace in the next few years and already earlier, that will actually drive the growth of that business. That business also is tilted very much towards The U. S.
There we have great partnerships that we are working on. Our own business here is very much focused here in the Scandinavia. And itself, we believe that this is a great platform to continue the growth. And as said, this is one of those businesses in healthcare, which still today is very independent from the interference by the payers or reimbursement actions. Thermion is a very different animal in our business concept because it's a capital expenditure heavy industry.
Majority of that that you invest are in capital and machinery equipment to keep the plants running. The R and D part there is extremely important for our own proprietary molecules to develop those to the scale of production and then at the commercial scale, but also then to continuously, of course, make sure that we are in compliance and also that we maintain our productivity because at one point of time, we will lose the market exclusivity, be that based on the patents or on the data. And at that date, then we need to continue to be competitive so that we don't give up that market. And I think there are great examples there. If we look at our Parkinson's franchise where we lost the patent coverage, yet we continue to supply to the market.
We continue to supply to the major players also in the generic space. So I think this demonstrates that we have high capabilities here as well. Of course, then when we look at the healthcare industry in general and the sub segment of that, which is called pharma, so far, pharma has been a defensive part from the investor perspective. There is obviously, there's volatility within the companies. And of course, for a size of company of Orion, any given innovation may actually make a very big difference.
As now the data suggests, darolutamide could be a very interesting treatment option for prostate cancer patients. That has a major impact to the company, as did Stalevo. It catapulted the company to the next level and I think dorolutamide certainly has the power to do that in the next years. In the pipeline, if we look at the next ones, what we have, which are underserved markets, ALS, think that was very vividly put by Sato here earlier on. And of course, in a totally new mechanism, should the 02/2009 pan out, I mean, we are addressing patients who, despite the fact that they have very, very high number of treatments, are untreatable.
If we are able to treat those patients, I think this would be great for the patients, of course caretakers there, close ones and for the society at the end of the company as well. This is not to say that we will not be immune for macroeconomic development, but at least so far, the signs from the be that the trade wars or alike, we cannot see the direct impact. Now if we take if we have the chain reaction, then compounding, who knows? There may be issues, but still, personally, I'm optimistic that the politicians that are in power, they will take care of their people and, of course, their healthcare and the pharmaceutical products, the access to those are very important to all the people, all the ones who are typically in power. So I think there are great opportunities from the industry perspective.
The megatrends are driving for the increased need of health care. And then that part also, of course, by the pharma. I think Orion is very well positioned. We have both the generic business, we have the high-tech business of proprietary. We have great opportunities in our pipeline and there's a strong will now to make this company grow and see what that where that takes us.
And it is very likely that this milestone that we set for ourselves, it's only an intermediate goal. That's the good start and then we'll continue from there.