Yeah. All of us who have watched the Eurovision Song Contest know that with these words, every good show starts. You are all warmly welcome to Orion's Capital Markets Day 2025. It's so good to see so many of you here in person in Helsinki today. For those of you who don't know me yet, my name is Tuukka Hirvonen. I'm the head of IR here at Orion. I would also like to welcome all of you who are watching us through the live webcast. Before we move to the agenda, a couple of words about the language options we have in the webcast, especially for the Finnish-speaking audience. We are experimental, as it is in the DNA of any innovative pharma company, and today we are using AI live translation in the webcast.
If you wish, you can choose Finnish subtitles from the bottom of the video screen, and there's also an option to use English subtitles if that's the case and you want to use those. Please note that there will be a slight delay in the subtitles, and what's more important, even though the AI translation is pretty good, in my opinion, these days, there still may be some inaccuracies in the translations.
And just for secure reasons, the same in Finnish. Joten tervetuloa kaikki suomenkieliset katsojat tähän Orionin Capital Markets Day -webcasttiin. Meillä on tänään mahdollisuus, tai teillä on tänään mahdollisuus hyödyntää suomenkielistä tekstitystä tässä lähetyksessä. Tekstityksen tuottaa suorana puheesta tekoäly, joten on hyvä muistaa, että tekstityksessä on pieni viive, ja vaikkakin tekoälyn käännös on jo melko laadukasta tätä nykyä, niin siellä silti saattaa olla pieniä epätäsmällisyyksiä, joten pidättehän sen mielessä.
Toivomme kuitenkin, että tästä ominaisuudesta on teille iloa ja hyötyä tänään. We can move to today's agenda. We have a great set of presentations today, with growth as the common theme. We will start with CEO Liisa Hurme's presentation that focuses on Orion's growth strategy. Then our business division leaders will each discuss what are their division's short-term growth drivers and also how they are building growth in mid and long term.
Finally, our CFO, René Lindell, talks about capital allocation principles and how our financial objectives provide us a framework within which we then manage our growth journey. There will be a short Q&A after each presentation. The only exception is the first presentation by Liisa. After Liisa's opening, we will move straight to Outi's presentation, but after that, Liisa will join Outi to the first Q&A session.
At the end of the day, we will have one longer Q&A session where everybody then will be present here on stage. If anyone here in the live audience wants to ask a question, just raise your hand, and one of my colleagues here will then provide you a microphone.
Please wait for the microphone before asking your question so that the webcast viewers also hear what you have on your mind. Also, the AI translator hears what you have on your mind. Kindly introduce yourself before asking your question. Our webcast viewers, you can use the chat function in the webcast to send us questions. We will try to address as many as we can during the time frames we have reserved for Q&A sessions, but unfortunately, we cannot guarantee that every question can be answered within this time frame.
Do not worry, we will later on publish on Orion's CMD 2025 website a document where we will then address all the unanswered questions. Do not worry if your question gets no airtime today; it will be addressed later. After the three first presentations, approximately at 2:25 P.M. Finnish time, there will be a 20-minute coffee and networking break here in Helsinki, and we will be back at 2:45 P.M.
One last thing for all the people here at the venue, please make sure that your phones are silenced. Finally, as usual, we have this disclaimer regarding forward-looking statements. This applies to all presentations today. That is all about the practicalities. Once more, on behalf of the whole Orion team, it is my pleasure to welcome you all here in Helsinki and also on the webcast. Hopefully, you will enjoy the day with us. Now let's kick off with the presentations, and the first presenter is our CEO, Liisa.
Good afternoon on my behalf as well. It's great to see all the people here at the venue, and also very welcome to everybody online today. I thought that I will not choke here at all, but I got a bit scared when Tuukka said that we are going to use AI today. I thought that you are going to replace me by AI, but not yet. Maybe one day. All right, let's get started. It's good to look at the big picture before we go to more details. Let's remind us of the 2024 figures. We reached our € 1.5 billion target ahead of our schedule already in 2024. You all remember we set us a target to be a € 1.5 billion company in 2025. Extremely happy about this. Last year, we made €470 million profit, which brought us to 27% operating margin.
We used €180 million for our research and development according to our strategy, where we've said that we are going to invest more and more into research and development. We are currently 3,700 people in more than 35 countries. Out of these 3,700, approximately 1,000 is out of Finland. The big figure in Finland is explained, of course, by our production sites, of which six out of ten are in Finland, and 1,500 people work at those sites. In addition to our manufacturing sites in Finland, we have two sites outside Finland, one in France and one in Belgium for animal health drugs. Here are our five divisions. I'll go through them one by one. They might be familiar to many of you, but it's good to start from the basics. Innovative medicines is probably the most different from the others.
It's based on fully developing new chemical entities in Orion's own R&D. Nubeqa is the current flagship product for us with darolutamide molecule, innovated by Orion and developed together with Bayer for global markets, and Bayer and Orion co-markets the product in Europe. Innovative medicines comprised last year 28% of our total revenues. I changed to our base businesses.
Branded products is a segment where our so-called legacy products are. Those are products that Orion has once developed as new chemical entities. They have faced generic competition, but the brand values have held very well. Most of all, we have long-term customer relationships in respiratory, central nervous system, and women's health. These products we sell by ourselves across Europe and in Asia-Pacific. Branded products is 20% of our total revenues.
I would say the real core, the heart, the oldest part of Orion is generics and consumer health. You can see that already in the number of products, more than 300 products. These products we sell in Nordics and Eastern Europe, and this contributed 37% of our net revenue last year. Animal health, again, a bit of a different division, focused on companion animals and livestock. All products are sold globally.
In animal health, we do a lot of innovation, but also generic products. This is a smaller one, 9% of our revenues. I know I get a question often that, "Why do you have animal health? What's the synergy?" There are synergies, especially within R&D. During the many decades, we've developed molecules first for animals, then for humans, and other way around.
Especially, of course, on the operations, there are a lot of synergies. The smallest of our divisions is Fermion, a company that Orion owns and that manufactures APIs. It manufactures APIs for all of our divisions, which makes Orion a very vertically integrated pharma company, which is a great thing these days, looking at the global supply chains. It also sells active pharmaceutical ingredients to other pharma companies, and this 5% represents that external part of the business.
Let's look at the last year's sales numbers and EBIT numbers. We clearly have a very strong track record on our financial performance. If you look at the percentages starting from 2022, after a rather stagnated period following Stalevo's patent expiry, we have really geared up.
Looking at the underlying business, the growth has been 12.6% in net sales, 7.2% if we calculate the milestones to this net sales. It is good to remind here that milestones are a very integral part of our business model, as we have partnered molecules like with Bayer, where we develop and market together, or we have fully outlicensed some molecules like Opevesostat to MSD.
We are getting either milestones related to development or then certain sales milestones. These create rather a lot of fluctuation between the years, and we are really focusing on our underlying business and growing that. On the operating profit, you can see the fluctuation even more. I am happy to report from the first quarter of this year, almost 15% net revenue growth and almost 40% operating profit growth. We are clearly on a new growth era.
That is about last year and the numbers. Now I move to the strategy. This is the strategy in a nutshell that we launched early last year, and it still holds. We are proceeding with all our strategic plans that my team will today share with you, both on expanding geographically and building both commercial and R&D portfolios. This picture clearly shows our aspiration to become more global, and also it shows that all business divisions have an important role in our strategy.
Here are the cornerstones for our strategy: building a customer-driven portfolio for all divisions. I am not going to read it through, but I am sure my colleagues will share more light on that one. Expanding geographically, and I will come back to that in my next slide, and developing growth enablers.
That means building capabilities both in R&D, in commercialization, further developing in sustainability, and also mastering the end-to-end value chain that is becoming more and more important in the current global situation. Data-driven execution excellence, which is kind of a monstrous word combination, but to make it very, very simple, as an example, we implemented a new ERP system in the beginning of this year.
Everybody who works in any industry knows that these types of changes and transformations might be challenging, but we are happy to be here today, and everything works well. Of course, it took five years for us to get here, so the program took five years, and we did it in a very thorough way. Now to the global aspirations. Of course, that is nothing new. All Orion products have been sold in more than 100 countries during the past decades.
From that perspective, Orion is a very global company. To have our own commercial or R&D or operations foothold is a very different thing. We started this already in the early 2010s when we expanded to be a fully-fledged European company by reacquiring Simdax rights, launching Dexdor, repatriating Stalevo and Easyhaler in European countries.
We further expanded in the 2020s to Asia-Pacific in a similar way with our known products, and the latest additions being commercial operations in Japan and R&D center in the United States, and the latest one from this year, R&D center in Cambridge, U.K. In addition to these locations, we have operations in India in two places, Mumbai and Hyderabad, and also in Shanghai. The strategy that I started with really focuses on building long-term growth into the 2030s, even beyond.
This is a long-cycle industry, even though there are a lot of things happening every day. Our growing revenues from Nubeqa and all our divisions allow us to invest more into research and development, but also to invest into needed capacity in operations or in R&D. This way, we can create EBIT growth and increase our dividends.
The financial objectives and framework, as Tuukka mentioned, offer us a great tool to balance between these things to increase our profitability and keep our expenditure in a certain framework. In a bit more detailed way, what have we then done? As I said, we've been fulfilling our strategic plans. Until today, Nubeqa has been launched first in 2019 for the first indication. We got the label expansion with Bayer.
We brought two new molecules, ODM-105 and ODM-212, into our clinical pipeline, and we have greatly enhanced our research pipeline. Professor Outi Vaarala will share more detail on that today. The geographic expansion—right now, we are focusing on filling the clinical pipeline, creating the capabilities that we need for further growth. Of course, to do that, we need new products through in-licensing or even external innovation through in-licensing.
When we shift the sight to 2028 and beyond, there are things to expect. We should have new indication for Nubeqa. There will be readouts of Opevesostat phase three studies, levosimendan in oral form hopefully gets an MA in the United States, and our clinical pipeline will be even more robust than it is today.
Of course, there is the aspiration, as I have stated, to be able to launch our own innovative products when they are suitable for our size of a company by ourselves. We would not be able to do all this on the innovative side if we were not maximizing the value of our core businesses, branded products, generics and consumer health and animal health. Here are the themes for today according to my presentations.
We will talk about the innovation within a few minutes by Outi Vaarala. We will talk about the geographic expansion, which is tightly linked to our portfolio expansion to fill in our commercial portfolio. Acquisitions are also on our agenda, acquisitions of assets, portfolios, or even companies, but they would need to have a very, very clear strategic fit to our plans.
We are all geared up with our very solid financial performance, our base businesses to build on innovation. I thank you for your attendance, and there is time for questions later on. Thank you, Liisa, for the opening remarks and setting the scene for the next presentations. I can see that there are some eagerly waiting for the Q&A session, but let's still wait for a while.
Let's first take Outi to the stage to present the innovative medicines and Orion R&D function. Outi, please. Good afternoon, everybody. It's a great pleasure for me to be here today and present our innovative medicines and R&D update to you. Here I have some achievements listed, and perhaps I can take two important points from here. We have here the success story of Nubeqa described, our darolutamide that we discovered.
We see here how darolutamide is taking more and more indications in prostate cancer, and that's a fantastic story for us in many ways and also for the patients. It shows how an absolutely good molecule was discovered by Orion scientists. We also have here another molecule discovered by Orion scientists, Opevesostat, and we can see that it's also going forward with expanding clinical trials.
The latest one here is the expansion to women's cancer from prostate cancer. It looks like our scientists are really able to discover and make innovations. We are confident about that. This list also shows how important partnering is for us, and we are able to do these kinds of partnerships where the partner can really carry the whole potential of our molecule that we have discovered. That's the best possible partnership.
On the left side, you can see the growth that Nubeqa brings us. With this partnering, we can see this kind of growth in sales, meaning growth of royalties to us, and this gives us this big opportunity to make a transformation that we have already started. We are in the middle of the journey. You see how many things have happened only during the past few years.
When you are in a transformation at a certain point or at a certain level, after that, things only accelerate. I believe that that moment we have at the moment. This is a repetition about the expansion of our Nubeqa to different indications. I want to remind you that we have still two phase 3 studies ongoing together with Bayer, Aralstep, and then Dasol-HyCap. The readout is soon, 2027 and 2028 for those trials.
Opevesostat. I think that here the new thing is the expansion, as I mentioned, to women's cancer, to indications like breast cancer, endometrial cancer, and ovarian cancer. Even without that, you can see that the development program is comprehensive. We have two phase 3 studies ongoing there, and then we have a phase 2 study also in prostate cancer, and here MSD is testing combinations of Opevesostat in that trial.
We are eagerly waiting for the readout from these trials, particularly, of course, from phase 3 trials where we test the efficacy of Opevesostat in mutation-positive androgen receptor ligand-binding domain mutation-positive and negative patients, both late-line and front-line patients with castration-resistant prostate cancer. Here you can see the goals that we have for our R&D and IMEDS. We want to see one or two new projects entering clinical development every year.
If we calculate based on this goal, the future, we have a goal that in the next 10-year period, we would have five to ten new phase 3 projects starting. That is a big transformation in Orion R&D. We hope to see a continuous flow of clinical projects, and for that, we need to do research. We need to guarantee that our research departments are able to deliver enough research projects to our pipeline.
You know better than anybody else how attrition is a problem in this field and in our industry. In oncology, we have still immuno-oncology as an important part, cancer genomics and cell signaling and ADCs. In pain, ion channels and neuroimmune interaction. The neuroimmune interaction team is synergistically working with the immuno-oncology team. The long-term target is that we will commercialize our products in the US and hopefully by ourselves.
This is a serious target for us, and we are preparing for that, and I will tell you later how. Here you can see the transformation that has happened until now. We have in Finland our small molecules R&D, which is extremely important for us. You saw that Opevesostat and darolutamide studies, which were triggered by the molecules that our scientists were able to discover. This is the golden core of Orion R&D, and we want to nurture that R&D also in the future. We have around 380 employees altogether in Finland in our R&D. We have in the U.K. a clinical development team, which is very important for us. We have also in Finland a clinical development team.
To make that dream happen, that we will have also a commercial presence in the U.S. where we can have our products in the market, we have now established also a commercial office in the U.S. In addition to that, we have developed or established a clinical development team there. We have at the moment seven employees there, but we have the right leaders now in place, and we are ready to expand those teams very soon.
These are the key recruitments that we have done in order to expand the teams with the right leaders. I'm very proud to present here that we have managed to recruit these kinds of leaders in the U.S. and in the U.K. In the U.S., we have Praveen Anur as Head of Therapy Area Oncology, Chief Medical Officer.
As you can see, he has a very, very strong scientific background in translational medicine and oncology. In addition to that, he has been working in pharma companies in the field of drug development and translational medicine. Gila Chaffe is our Chief Commercial Officer, also working in the U.S., and she has a very strong commercial background, also a lot of background in pipeline and portfolio strategy planning.
She has been working in many pharma companies, as you can see, and her strong area is oncology. Finally, head of our R&D biologics side in Cambridge, Eugene Chukovsky is one of the world's leading experts in the field of technology of therapeutic antibody discovery. With this team, I believe that, as I said, things can only accelerate.
Here I want to share with you our research pipeline so that you understand where the clinical trials and studies actually originate. There are a few points that I want to raise here. If you look at the pipeline at the moment, we have here half of our research projects in small molecule area and about half in the area of biologics, other modalities. I also consider also ADCs as biologics.
It is easy for you to understand why we need this center in U.K., Cambridge. We need to have the right leadership, the right scientists and CMC experts to bring these to the clinical phase and do this research together with us. The other point here is related to the thing that we have in the first upper part, three research projects or preclinical projects that are moving very fast now into the clinical development pipeline.
We have already selected candidate drug, and we are preparing the start of phase I for those molecules. This means that in 2026, we will have three trials that are started in the field of immuno-oncology and in the field of biologics. Two new things for us, and that is the reason why we want to have the right experts to help us and to guarantee that we are successful with these new approaches that we have in our R&D.
If this is here, I want to illustrate the year 2026 when our clinical pipeline looks like this. I am very proud of this, that our scientists, together with our partners, have been able to deliver all this. We have in clinical pipeline ODM-105, a small molecule, which is an opportunistic project. It is an old Orion molecule. Here the indication is insomnia.
We have estimated that we have phase two readout in 2026, and then we will see the readout and move on to phase three. This molecule is alpha-2A receptor agonist, and we know that this molecule causes sedative effects. Now it is important to see whether it works also as insomnia medication and can bring the right efficacy and good safety profile.
We have learned from studies with these kinds of molecules that this molecule brings refreshing sleep with natural sleep pattern, and that could be an important differentiator of this molecule in insomnia. ODM-212 is our TYK2 inhibitor, and we dare to say that we believe this could be the best-in-class molecule in this TYK2 inhibitor class. The reason for this is our favorable PK with this molecule, PK profile with this molecule.
Also in our ongoing phase one studies, we have already seen efficacy signal. We have seen in the patients with hypopathway gene alteration in their tumor, we have seen tumor shrinkage. We are extremely excited. Also safety profile looks very good. Until now, our molecule has been well tolerated. Now we are more confident when we think about our ODM-212 program. When we think about rare cancer indications, those with hypopathway gene alterations, here we could have the first product which we could commercialize in the U.S.
This molecule has also more broader opportunities. This molecule in our preclinical models also works in different combination therapies. It is a molecule that can prevent the development of resistant mechanisms when we talk about EGFR or KRAS inhibitors, for example. Those studies are, of course, something that we have also in our plans.
Here you can see results with our ODM-212 in mesothelioma xenograft model. In this model, our molecule is working very nicely and inhibiting tumor growth. As I told you, we have also some signal of efficacy in our clinical trials in humans. Now I go to the future building blocks that we have for our growth in innovative medicines. We will grow, of course, through innovation. It's our mission, and our internal R&D has been the major source for the innovations, as you see, with focus areas in oncology and pain. In addition to that, we are actively searching and scouting for opportunities to in-license development level or phase assets, as well as we are looking for commercial assets.
This is very important work, and it's important from this perspective that we have our Chief Commercial Officer in the U.S., and we build also these capabilities in the U.S. to enhance our pipeline and build opportunities for commercial entry with these kinds of actions. All these things that I mentioned, innovation, in-licensing, and inorganic growth, all these things are bound to geographic expansion. It's important for us to be exposed to the world, exposed to the world with the best talents. We have started that journey now in the U.S., and we will go forward with that mission. I think that this was my last slide, and now I invite Liisa to join me, and we will have a Q&A session now.
Thank you, Outi. Thank you, Liisa. If you want, you may take a seat for a while before we start taking questions here from the audience. I'd like to remind the webcast viewers that you have the opportunity to send questions through the chat function in the webcast. Please utilize the opportunity and send us questions. Now we can turn to the audience, and we have the first question coming from Anssi. If you can provide the microphone to Anssi there.
Thank you. Anssi Rausch from SCB. I start with your planned presence in the U.S., and of course, ODM-212 is part of those plans. What kind of other products could you see taking to the market by yourselves, or is it all related to ODM-212? A very good question, and I might start here. Definitely, I think it's a spearhead for U.S. plans, ODM-212.
The current indications that Outi already mentioned are rather small, so they would definitely fit well to our US strategy of a mid-sized European company. From our own portfolio, then it remains to be seen how ODM-105, you know what would be the exact indication when we see the phase two results. Of course, as we stated, we are all the time looking for other products then if we decide to go there with a certain molecule to complement that and create a portfolio.
Maybe continuing on this, should we draw any conclusions regarding ODM-212 if it's suitable for you to take to the market by yourselves in the U.S.?
We know the indications that were mentioned. They are small indications, and we know where the patients are treated, so that would be something that would be suitable for Orion size.
Maybe one more question from me, and of course, we have not heard CFO's presentation yet, but you mentioned that all the divisions have a license to invest and grow. What kind of thresholds do you have for this growth, maybe in terms of return on capital metrics, and have these thresholds changed over the recent years?
I here refer back to our financial objectives, which gives us a very good framework. We are stating there our return on investment target, which is at least 20%. Of course, we have also stated there our equity target and our growing dividends. I think that within that framework, we are able to invest in all our divisions. Of course, we need to understand that the investments needed for different divisions are very different in their size.
If you would invest into generics acquiring products, that's probably a very different size of an investment than acquiring a product for global innovative medicine. I think there is room to operate within a certain timeframe for the benefit of all divisions. I leave it to our CFO to comment more on if you are aiming for the firepower for any acquisitions. May I go back to the first part of the question?
About 212, when we talk about these small indications, as Liisa referred to in my talk, those are the indications that I was thinking about, like entry indications. Of course, when we talk about the combinations and indications related to those combinations, like KRAS inhibitor combination with TEED inhibitor, then we are talking about much bigger indications.
We always consider, of course, the option that we will commercialize ourselves in the first place. Depending on the size of the indication, depending on the development of the whole product portfolio, we do each decision at the time when we have enough data for that. There are also big indications that are potential indications for ODM-212.
Sami Sarkamies, Danske Bank, I have a couple of questions starting with Liisa. Just curious, you issued financial targets last year. Could you comment on your progress relative to targets so far? Have there been any sort of material surprises? Do you think you would be in a position to update these targets before they actually expire?
You 're talking about this year's outlook or the financial objectives?
The mid-term financial targets.
Mid-term financial objectives. We are proceeding very nicely according to those objectives currently. I think that says it all. I do not think we currently see any need for updating those.
Okay. For Outi, a couple of questions. First, starting from the R&D cost base, could you somehow elaborate that what is kind of like the Orion R&D platform cost? What is it at the moment? What was it a couple of years ago? Given the decisions you will be making, where could it be a couple of years down the road, kind of like the fixed part of R&D cost that is not related to any clinical programs?
You remember the figures from last year and this year, and we can see there a significant increase being around 30% in R&D costs. This has been very important for us, and it's something that is based on our R&D success, you know, on the figures that Darolutamide is bringing to us. When we have planned to expand our research pipeline, we have calculated the scenarios for our business cases that can arise from this pipeline.
We have taken in the calculations attrition also, which is something that is the part of this game. When we see then the increase in the Nubeqa sales, and we relate that to the increasing R&D costs, I don't see any problems to fund our R&D programs that we are now raising from our research pipeline. From the development perspective, we might have a positive problem if we have really large indications that are suitable, for example, for our immuno-oncology assets.
In that kind of positive case, we might need also external funding. At the moment, this building of R&D pipeline, it's very realistic based on the forecasting that we have. When our development pipeline is going to expand, R&D costs are going to be increased significantly, of course. We hope to see an increase, significant increase in Nubeqa sales.
Maybe to continue, I think also the question was related to fixed cost base. Clinical programs will bring an increase, as Outi said, definitely. When it comes to the fixed cost base and expanding to different geographic sites and establishing new centers, that of course increases also our fixed cost base. Again, we are doing very detailed calculations and decisions as we go along and see that it is doable and we can proceed in a profitable way.
The majority of the costs are external.
Definitely.
Maybe a couple of more detailed questions on specific programs. ODM-105, are you still looking to partner that program? I think you mentioned plans to take it into phase three after readout next year.
Yeah, when I said that, of course, you may take that to phase three together with a partner. We will see when we have a phase two readout how the molecule is performing. In this situation, of course, our major interest is to build commercial operations in oncology, as you can guess.
Okay, on ODM-212, what would be a realistic timeline for initiation of those phase two programs you have been talking about?
Realistic timeline is in 2026, and I would say that it is latest also year for that. We would be ready with these trials now, yeah, very soon.
Okay, and my final question is on Nubeqa. There's this one phase three program run by Bayer alone. Are you planning to opt in, and what could be the timeline for that?
Yes, sure, there is a possibility to opt in, and we are, of course, following the study and will make a decision as we go along.
Thanks. Hello, this is Matti Garo from OP Markets. One question regarding your people strategy, because you were speaking a lot about the enablers, which is R&D, and then also the commercial capabilities, which both are requiring a lot of talent and also new talent. Typically when Finnish companies are expanding to foreign new regions, they are hiring very prestigious people, talented people, so-called rainmakers. The problem is that those rainmakers do not have anymore the capabilities they used to have with these global huge companies. How are you mitigating this kind of mismatch that has happened, for example, in Nokia or in Neste in the past days?
You want to take this one?
I think you can. Yeah, you have been doing a lot of hiring lately.
Yeah, of course the plan is that these hires that we have done now, those leaders in the U.S. and U.K., they build those capabilities for their own functions. We also have capabilities here in Finland, for example, if we think about our recruitment that we did for the CMO role, that you saw that CMO person who is now going to start with us is an expert in the field of oncology. We have already capabilities. We have shown that we are able to discover and develop small molecules, particularly here.
We have capabilities, but we just need to add those capabilities, fill the gaps. In this way, I do not think that this is a really difficult journey, actually. I believe that we have, in a way, a good foundation to start with. The expansion will happen and will be planned by these leaders that we have hired. Maybe I can continue to that. I think the new recruitments also have a very wide background, both from the big pharma and then the smaller pharma companies and startups. They are surely also used to work without the huge resources that you are referring to. Thank you. We have one question at least from Iiris there. Hi, this is Iiris Heiman from DNB Carnegie. Regarding Opevesostat, what is the potential addressable market for Opevesostat?
Basically, how does expanding its use to treat women's cancers impact that figure? Maybe I start from the potential. It's, of course, MSD who defines the potential for the drug. I encourage you to ask that question from MSD. When it comes to women's cancers, Orion is entitled, I'm just talking about our agreement and all that. I let Outi continue on the patient population if you want to say a few words. We are entitled to similar type of royalties on the other indications outside prostate cancer. The new indications will build up the probability of success and future royalties. Maybe you want to say a few words about the women cancer indications. Of course, in prostate cancer already, the potential is really big, as you can estimate yourself.
If we think about this women's cancer in the trial, you can check this also in the clinicaltrials.gov. The breast cancer cohort in the study, which is one of those cohorts, it's in hormone receptor positive and HER2 negative breast cancer, metastatic breast cancer, in whom Opevesostat is tested. The control is other endocrine treatment or comparator. In that way, it's a big patient segment, very big patient segment there.
When it comes to endometrial cancer and ovarian cancer, there we have a much lower patient group that we can believe that the drug could treat. This breast cancer is a big indication. How do you see competition in this field? Basically, are there any competing therapies in development? You mean now specifically this women's cancer trial? There is a lot of competition in general in the oncology area.
In breast cancer, we know that the competitive landscape is challenging. On the other hand, Opevesostat, the mechanism of action is unique. It would be a first-in-class molecule to control hormonal activity. The mechanism of action is to remove all steroid hormones. It is very different from the present hormonal treatments that we have in breast cancer. From that perspective, I think that it can really differentiate, and that is important. When it comes to ovarian cancer and endometrial cancer, in oncology, as I said, no area is without competition. There, I think that it is the same story that this unique mechanism of action may bring something totally new. Of course, the most straightforward indication here is breast cancer.
Final quick question, if I may. Does the licensing deal with MSD include any other molecules than ODM-208 and ODM-209?
Of course, in those patents, the space that is covered is usually larger. But when we think about these kinds of drug molecules that are ready to be used in the clinical trials, ODM-208 and 209 are the molecules.
Okay, thank you.
Thank you, Iiris. Any further questions here? We have one question.
Thank you. Sean from Jefferies. Just firstly, in terms of your plan to establish a commercial footprint in the U.S., particularly on your innovative medicines portfolio, so you already have this R&D center. Would that sort of confer establishing a manufacturing footprint in the U.S. as well, or would that more be sort of having CMOs and CDMOs to manufacture products?
Very valid question. No, we are not planning currently any manufacturing operations in the U.S. It's now clinical, regulatory, and commercial operations in that R&D and commercial hub or center in the U.S., but no manufacturing. We have, as stated in the beginning, a lot of manufacturing sites already in Finland and Europe. Currently, we are relying on those.
Okay, just one more quickly. In terms of BDE and innovative medicines, is there a specific peak sales that you target when you're looking at sort of bringing on a product to your portfolio?
Regarding specific peak sales target, of course, that is a bit limited. I'm not going to say any numbers here, but I get back to my comment on that any such molecule would need to be, the indication would need to be such that it's very specialized or treated in certain hospitals, so big centers, so that a mid-sized European company can also handle. We are definitely not looking at very, very big blockbusters or drugs that are prescribed by generalists or GPs.
Thank you so much.
Thank you. It seems that we have exhausted all the questions here in the audience. We have time for one or two online questions. Do not worry, on the webcast, we will come back to these latest in the final Q&A in the end. First of all, to Outi maybe, do you have an outlined set of dream number of headcount in the R&D unit for 2026-2027? If we now calculate the figures from your slide, the total number once the Cambridge is up and running is roughly 440 people. Any aspirations to expand that or what is the figure you are thinking? When we think about year 2026, then we can say that 450 perhaps is the number that I can give.
If we talk about years after that, as you all know, it's a certain range that I can only give because everything depends now on the success of our projects in the clinical phase. In 2027, we have very many important milestones and readouts. I talked to you about the phase one studies that are going to be started in 2026. During phase one, we already see safety and efficacy signal usually in oncology. Those years are extremely important for us and determine then the future possible growth.
Thank you, Outi. Thank you, Liisa, for this Q&A session. Thank you for the good questions. We'll continue in the next Q&A session. Now it's my pleasure to invite on stage our Executive Vice President, Hao Pan, from the Branded Products Business Division.
Hello, good afternoon. I would like to start with an overview of Branded Products Division, just to give you a little bit more insight into how we're organized. In terms of therapy areas, we also mirror our business subunits according to it. You can see that we have respiratory, that's our biggest part. If I can borrow our quarter one publicized net sales numbers, you can see 60% of our net sales in quarter one this year is in respiratory.
Then we have CNS. We have long heritage of this. A majority of this is in Parkinson's disease. That's 30%. We also have women's health. I know some of you were quite impressed by our number last year in terms of growth. Maybe I can share some lights with regards to what we're doing and what we're planning to do.
What we're trying to do is to keep it quite simple. We have to be quite focused. We will build our portfolio around our legacy brands, our key products. In respiratory, you have Easyhaler range. This is the inhaler range products for treatment of COPD and asthma. This is our most important brand within branded products. You can also see that Ryaltris, this is a combination nasal spray treatment for seasonal allergy.
We have the distribution rights in Nordic countries. We are hoping that we will be able to in-license more products like this for treating respiratory conditions. In terms of CNS, it's probably not surprising to all of you to see that most of the brand here is focusing on Parkinson's disease. Our entacapone brands of Stalevo and Comtess were joined by Oridopa. This is Orion's brand for levodopa.
We have been launching this during the last 18 months. Because they are launched gradually, I would still like to say this is still in launch phase. Also, a new brand name here to some of you probably is called Suvex. This is an in-licensed product. We are branching out slightly to the field of migraine treatment. This is a combination product for migraine treatment, and it is in launch phase.
For women's health, our key product is Divigel. Sandrina is the other brand name in some key countries. That is why we have Divigel and Sandrina here. Basically, this is a transdermal HRT treatment, estrogen in a gel format within sachets. This is for treatment of menopausal symptoms. We also have Indovina, which is our oral tablet, continuous combined oral treatment for menopause symptoms.
This really leads me in a very natural way to talk about our divisional strategy. Again, from the very beginning when this division was set up over two years ago, we wanted to keep it simple. I am trying to explain to you. In a way, we want to do two things well. First of all, we need to maximize what we have. We realize these legacy brands still have a lot to give.
We just need to up our game to invest accordingly and to do various things and to make sure that we really can be competitive and can be valued by our targeted customers and for the patients that we serve. The second thing is to utilize the synergy and the platform that we build from these older products, these legacy brands, and hopefully to have new products adding to it.
Then achieve profitable growth this way. The majority of the things we're doing is through in-licensing, but we also have some own development projects. These are mainly generic development projects, but I'm hoping to show you, especially in Parkinson's disease, some examples and just to try to explain what we are trying to do.
As Outi has already talked about in terms of geographical expansion, branded product really serves one geographical expansion purpose here is that we consolidate what we have in Europe with customer engagement because we still haven't got any innovative products for us to launch ourselves at this moment. We do not want to lose insight and experience in terms of engaging with customers. More importantly, in Asia-Pacific, more or less all our products, which make significant inroads, are branded products.
The latest example is that we established in Japan last year is through repatriation of our Parkinson's brands, Stalevo and Comtess, and also Divigel, our product for treatment of menopausal symptoms. We play a good important role here. We want to make sure we have the setup, we have the commercial footprint, so we are ready when the time is right to bring innovative medicines to Asia-Pacific.
One thing I want to highlight here in terms of the growth enabler. In terms of manufacturing and API, this is very critical to our division. We are very happy these critical competencies are within Orion's own hand. We are continuing our investment to make sure we have this. Also, the other thing I want to say is that we need to be continuously to perfect or improve our omnichannel customer engagement.
We know we are not the big guy. We cannot simply throw money in terms of commercial footprints. Maybe COVID has not been too bad overall. There is some silver lining in terms of customer engagement with the trend moving towards hybrid calling, online calling.
A medium-sized European company like Orion can now really compete with the big guys because simply I think when you are online, you are quite equal in terms of the share of voice that you will be able to get. This is something we are really going to do. Above all, everyone in branded products are really motivated by two things. We would like to work very hard to realize the Easyhaler portfolio's potential to exceed EUR 300 million in annual sales.
I cannot promise you how soon we will reach that, but we really believe if we do things right, this is a realistic goal that we might be realizing this potential. Secondly, we are all very motivated. We want to be in a unique position to be able to offer cost-effective medicine to all stages of Parkinson's disease. Not many companies can say that. I have got a slide I want to quickly show you.
The reason I say that Easyhaler will be able to climb new heights is because we believe Easyhaler has the right credentials for continued growth. Here on the left-hand side, you can see this is a snapshot of the growth rate from Orion's own operation countries in 2024 over 2023 of the Easyhaler sales. All the key countries are having quite decent numbers, if I may say.
This is not only a reflection of more and more prescribers and patients really liking the simple device to use because with Easyhaler, all you need to do is basically shake, click, and inhale. That is very easy to learn. We have the same device for six different products, so you could really have choices. Some patients do not need to learn another inhaler, and they can manage in the way of treating asthma.
These are really quite unique for Easyhaler. On top of that, our knowledge in the dry powder inhaler technology, because we developed Easyhaler ourselves and our own controlling API and manufacturing, ensured that we can compete in terms of continuous supply. We do not have disruption in supply chain, and we can also ensure the quality of our products is great.
This is something we are all very proud of. We want to make sure that we can leverage this more and more. More importantly, this is the top half of the picture on the right-hand side. External factors. You have all heard about this green initiative. There is a trend, the preference for greener, so-called greener inhalers. Dry powder inhalers do have less CO2 emission. What we are very proud of is that Easyhaler range is officially carbon neutral certified. This fits really well with a lot of climate-conscious prescribers and also patients. Of course, drug needs to work. On the basis, it suits patient clinically. I think this bit of the green credential we have is really working for us. On top of that, this is something probably we have not said too much.
We also fit very nicely with the new international and national guidelines for asthma treatment. One example is that GINA, this is a global initiative for asthma. They are recommending MART. This is maintenance and reliever management way of asthma in all stages. They specify inhaled corticosteroids with formoterol. They specify this latter specifically because of its unique quality. This fits very nicely with Buformix Easyhaler because that is a combination of ICS and formoterol.
We believe that sets us apart and we can compete even better in the future. Now, I am actually very excited to show this slide because every time I show this slide internally, I get really good feedback from my team. This is something we are all working hard for. We want to expand our Parkinson's offering to all stages of Parkinson's disease.
We know our offerings are cost-effective and it's affordable. You can see that Orion already has products in a lot of these stages. We are doing, in terms of our own development or co-development projects, and we are also in-licensing so that we can say we have more products which will suit individual patient needs and for the Parkinson's treatment clinicians to have the choice from. Just a few words about the own development product.
We cannot really disclose too much details on this, but just to say they are not new chemical entities. I just want to make sure that's understood. What we're trying to do is because every single minute of more own time for Parkinson's disease patients is meaningful to them. It really helps them with their quality of life.
We're trying to put in different combinations of generic compounds together, or we're trying to see the different route of administration we can do with these generic compounds because we know that will be meaningful to the treatment and it will be used and you will be appreciated. Maybe just a few words about the two products that we in-licensed recently and which you are aware of.
First of all, we have in-licensed a micro tablet of levodopa in a special dispenser device. This is for later stage in Parkinson's disease. To deliver levodopa in this way is to smooth out the unpredictable peak and troughs of all the symptoms. The current choices for those patients is very much invasive treatment. This we believe could really add value to it. Those invasive treatments tend to be very high priced and quite costly.
In the same way, we are very happy to share with you that we have in-licensed Apron. Apron basically will be the first oral mucosal spray way of delivering apomorphine. Apomorphine is a very well-standard rescue medicine for Parkinson's disease. Currently, the only available administration route is through injection or infusion by a pump. You know, when you need rescuing, the ease and convenience plays a big part.
A few words about women's health. Basically, as I said, it is Divigel and Sandrina which is driving our growth. I will be very happy to tell you how wonderful we have done to result in our good sales increase. However, I have to say that we have been so far very much simply riding the wave of the transdermal HRT resurgence.
Here you can see the market growth during the last two years in Europe, U.S., Asia. It is really quite nice, especially in English-speaking countries. I think there is a political climate. Women simply no longer want to suffer in silence. They really want to have the rights to treatment and have the way to judge weighing the risk and benefit of HRT treatment.
Transdermal HRT is really preferred because it is perceived or there is evidence to show that it is slightly safer. Our gel has done extremely well. Maybe just a few words about our gel. I'm not trying to sell this. I just want to be very careful here. Our gel is coming in a sachet. The beauty of that is that each dose with one sachet, you know exactly what you're getting. The accuracy of dosing is important to the patient.
This common sense will know that. That is why it is doing very, very well. Based on that, we are now really reinvesting in some commercial activities in the countries where the transdermal HRT market are recovering very evidently. We are relaunching in those countries. In some countries, we are finding new partners. That is one thing we are doing. The other thing, maybe more interesting, is that we are looking at the range of dosing and presentation, different presentations to try to cover all stages of menopause.
Majority of this work and idea we have explored does center around Divigel, probably more Divigel line extension. I cannot share too much with you, but just want to say that there are initiatives that we are doing. We have very, very experienced experts still in the company who know this field very well.
To summarize, we think that our products, we know our brand, our legacy products, you do not become legacy if it is not too old in a way. They are well established. That is the word I would use. This is actually good for us. The way we choose to focus is because we know we have been in this field for more than 30-35 years. Parkinson's disease, Easyhaler respiratory inhalation, HRT, Divigel.
On top of that, because we have the European manufacturing, and this really matters to people, and we have the full value chain control from Fermion API to our own R&D heritage, all the way through our own sales and marketing operations in over 30 European and Asia-Pacific countries. We believe with all of this together, we can serve our customer and patient in a very good way.
With that said, I just want to share with you our branded product motto: "Life begins at 30." Any human being will know 30 is the golden age when you start to go into your prime. That is what we say within our organization and seems to get good reaction. Thank you very much for your attention.
Thank you so much, Hao, for the inspirational presentation. Now I open the floor for questions to Hao here in Helsinki. Let's start with Anssi again.
Yes, Anssi Rausch from SCB. Just one question regarding Parkinson's disease product family and also Divina series like. What kind of potential we could expect in the coming years in these product families and looking at these growth rates in the targetable market in Divina series, of course, looks impressive, but is that the expected reality in the future as well?
We are sort of not in the tradition of disclosing individual sub-product group in terms of the sales projection. Of course, we've chosen these fields to focus on. We definitely will do our best to make sure we have good results in the future. Basically, there's no clear reason why Divina series shouldn't follow the basic market growth. There are always external forces or factors which can be slightly unpredictable. I do not want to make that promise. Certainly, we internally, we're going to work very hard to try to achieve.
Thanks, Anssi. Any further questions here from the audience? Sami, please.
Sami Sarkamies , Danske Bank. Regarding your € 300 million sales target for Easyhaler franchise, would you need to make additional sales and marketing investments to make that happen, or is the current platform strong enough?
We know Easyhaler has been the first product that was launched over 30 years ago in Finland. It was gradually built up. This is really a beautiful story because it just continues to give. We, as a company our size, and we know with regards to asthma and COPD, our competitors are really quite big players. We have always been in terms of investment side of things and not really at the same scale. It works for Orion. We are not going to change too much from how we have done because we think that works for us. Everything we do is very much looking at the ratio in terms of what we can get and what makes sense. We will invest accordingly. Liisa has given me this autonomy.
We certainly, within my team, will make sure that we track the growth and we will invest if needed, for instance, in one particular country or whatever. It really depends on how the competitive environment changes, how the local treatment guideline goes and things like that. If there are opportunities, then we will invest.
Okay. The second question on the Parkinson's business. It's been rather stable since around € 100 million a year. Do you think this is the case also going forward, or could you even target growth in this area?
Yes. With Entacapone alone, you probably wouldn't believe me if I say we want to grow it because the patent expired more than 10 years ago. With Parkinson's, the picture shows what we want to do is to add new things to it. Yeah, I would like to hope we will have growth. Otherwise, I won't be here to talk about it.
Thanks. Good luck.
Thank you.
Any more questions here from the audience? We have one from online, but that actually also asks what is the peak sales potential for Precifit. You already mentioned that our policy is not to provide any individual peak sales potentials to these products. After all, it's still in the development or regulatory phase. We do have the MA in Finland and reimbursement, so we will launch first. The process is ongoing elsewhere. Yeah. We have still time for one or two.
Yeah. One quick question regarding these geographic expansions. What are the competitive advantages you are levering with when entering the new markets because you are kind of a new player trying to get the market share from the established players there?
Yes, I think this is very in a similar line with you have directed to Outi. This is very tricky because maybe I can comment on this because I come from a large pharma. I have been with Orion for a long, long time. I have to confess, when I first joined Orion, it was not the company which attracted me. It suited my career development.
The minute I joined the company, I realized actually the company culture and the way how it works really fits my personal goal and my personal value. It just worked very well. I would say in my U.K. colleagues, a lot of us are average. We are there for a long time. It's not because we have an easy life. It's really to do with the same kind of like-minded people gathering.
Last year, I was responsible in recruiting and setting up the Japanese operation. I have to say it was not easy. We interviewed a lot of people, but in the end, we found really good leaders locally with similar kind of. Maybe we were a bit lucky. Because the leader is like-minded, the team that he or she builds tends to be the same. So far, I would say that we have been very lucky in that sense that we have good people in almost all foreign subsidiaries. I know this is, I do not want to say that this is not difficult, but we think that the match of company value and personal value is the key here.
Thank you.
Thank you, Matti. Thank you, Hao. Once again, we have exhausted the time for this Q&A session. Again, for the webcast viewers, we will come back to the questions you have sent. Thank you for those. Please be active also during the next few presentations. Now it is time to have a short 20-minute coffee and networking break here in Helsinki. We will be back online at 2:45 P.M. Finnish time. See you soon. Thanks.
Welcome back from the break. It was so nice to see and hear all the buzz here in Helsinki, so lively discussions. Hopefully, all are refreshed now, and hopefully also all of you at home or office, wherever you are watching the webcast, did have the chance to grab a cup of coffee or something. Now it is time to continue with our interesting presentations, and it is my pleasure to invite to the stage our Executive Vice President of Generics and Consumer Health, Mrs. Satu Ahomäki. Please.
Good afternoon, everybody. It is my great pleasure to tell you about the Generics and Consumer Health Business Division. Liisa already in her opening speech talked about the characteristics of this business. Broad portfolio, focus countries are Nordic and Eastern European countries. I might add one more thing there. 75% of the sales is coming from generics and the rest from consumer health.
If you have been following us in recent years, you might feel a little bit disappointed about the negative trend of the top line. There are three obvious reasons for that. First of all, Russia, then Dexdor and Simdax. In 2022, Orion made the decision to exit from Russia for various reasons. It actually was quite a long process.
It was so late in the first quarter of 2023 when we managed to sell our remaining stock there in Russia. Dexdor patent expired in 2019 and Simdax a couple of years later. They both have been many years in Orion's top 10 best-selling product list. When the patent expired, naturally the competition followed and prices go down. That is why the sales are decreasing.
However, if you look at this picture here, you can see that the foundational portfolio is actually doing quite well. From 2022 to 2024, the CAGR being almost 5% and last year was really excellent. We grew almost by 6%. There are a couple of reasons behind that success, if you will. Active in-licensing. We have managed to grow in our portfolio and have constant flow of new launches every year.
Also, we have very strong market insight in those countries we are present. That will, of course, help us to interact with the customers, but also lead to successful pricing strategies. That was about the past. I am going to talk about the future. This picture here illustrates our strategic roadmap. This business division's vision is to really deliver profitable growth also in the future with focused portfolio, enhanced customer engagement, and versatile commercial channels.
On your left-hand side, you can see the focus areas. We have chosen four of them. Of course, this growth generation is the most important one. We do understand that although our key market, Finland, we are number one in Finland, we need to maintain that business and even defend our market shares there and also in other focus countries.
However, in order to increase the business outside Finland, and I talk about the big five countries in Europe, we need to transfer our portfolio. The current portfolio, what we are having in Finland, it's not something what we can copy-paste to Germany, for instance. Some of the products are old products with old regulatory dossiers. We can't expand the regulatory approvals anymore to other countries, or they might be in-licensed products.
We don't have, we have only restricted territory. Otherwise, the cost level structures are something like that, that we can't really be competitive in other countries. Therefore, we need a transformation. Here are the key actions under those strategic focus areas we are committed to. When we talk about the growth generation, we are continuing to accelerate this new product flow through in-licensing, but also through own development.
We also want to pilot new things to find our path forward. We are piloting new sales channels in consumer health. Currently, in all countries, we are only in pharmacy channel. Portfolio management is very important. As I explained, our current portfolio is not particularly suitable for all the other countries in Europe.
Therefore, from hyper-generics, by hyper-generics, I mean those very competitive generic compounds like statins, for instance, very low priced. We want to move towards complex products, complex to manufacture or develop, and value-adding generics and biosimilar products. In consumer health, we have traditionally been one country, one brand. Now we are trying the first multi-country launches. We want to utilize the synergies between the countries as well and be more cost-efficient.
When we are entering to new geographies or other new customer segments, new channels, then we need to make sure that we have the relevant capabilities in place as well. We are currently building these commercial capabilities in big five countries, for instance, and really to excel in customer engagement. Last but not least is profitability optimization, which is really core in this type of business.
We are really driving our profitability through healthy price levels and also increasing volumes because that's one way of managing the profitability. We actively manage our cost base both in sales and marketing and also in development side. We try to be very efficient and lean in our internal processes and processes towards the stakeholders.
We have a couple of projects which support our growth, value-add growth project, direct-to-consumer online pilot, and then certain products we outsource in order to manage the profitability. About value-add growth project, it has two main objectives. To create this portfolio of value-add hospital generics and then also build the required commercial capabilities, especially in the Europe big five countries.
What I mean by value-add hospital generic, it's a product which brings something extra beyond the standard generic compound. For instance, there could be an originator product which is used in the hospital and it needs to be stored in cold chains, so refrigerators. What if we bring the same molecule, but in that kind of formulation that it can be stored in room temperature? You can only think how much extra work that will cut.
There will be less things to remember, to manage, less opportunities for mistakes. There are also other types of value-add characteristics, but this is just to mention one. This is the project we are very committed to. We source products to this portfolio through developing them ourselves, but also through in-licensing and then strategic partnerships.
During this strategy period, we are going to invest in this certain amount of EUR, but I assure you it's nothing significant, quite moderate actually. It consists of the licensing fees and then some of the regulatory costs and then development costs. In our case, we don't talk about the big phase three type of development cost. It's more like a formulation development and pharmacokinetics, bioequivalence, things like that.
As a result, I hope that during the strategy period, we will have a portfolio of this value-adding hospital generics, which will then generate increased sales to the business division. The other project I like to talk about is the direct-to-consumer pilot, our online store called Well by Orion Pharma. It was launched last week in Sweden. It's really the aim to learn more from the consumers. It's targeting for mothers and babies.
The product offering is planned for those customers, creams and ointments, products what mothers and babies need. The thing what differentiates this online channel from the other online shops is that this is really expert-created portfolios what we are offering. We also offer credible source of information. We all know how much information there is in social media, and sometimes it's difficult to say what's right and what is wrong.
This is absolutely correct information. It gives also expert guidance to these customers. This is a pilot, as I said. Next year, we will then see the outcome, the results, and then we can make the further decision about the continuation or possible expansion to other countries. I always love to talk about the capabilities and competitive edge, since in this business, I think that we have a few of them.
As many of you probably know, we are in the leadership position in Finland. The total market share is 11%, and in reference price products and consumer health, it's as high as 25%. Also in Scandinavian countries, we are doing very well in generic business. Last year, we managed to go higher position from position six to number five.
In Poland, we have many years been on the row, the fastest growing generic company. What then really facilitates that, I believe it's our portfolio, the broad portfolio. It's also the very strong partnerships what we have with our key customers like pharmacies and healthcare professionals. Also, we are quite advanced in this digital presence. In Finland, we have several digital platforms through which we are communicating with the customers.
Now this new online channel in Sweden. I'm approaching the end of my presentation, and this is my summary slide. Yes, in this business division, we are looking for growth. We look growth through the innovation. It's this transformation of the portfolio towards complex and value-adding generics and also new channels. The other area we are looking for growth is through geographic expansion. Europe big five is our current thinking.
After that, of course, we need to think about the other geographies as well. We do grow through portfolio expansion, and we have those tools which I already mentioned, the in-licensing, own development, and through strategic partnerships. There is this interesting question about organic versus inorganic growth options. Believe me, we have evaluated several hundreds of companies to see if there is something Orion could acquire.
Although there are wonderful companies all over the world, at least we haven't quite found our match as of yet. Although they would bring a good increase to the revenues, it requires the investments as well. We just haven't found yet the way how to make it a good fit. However, after having said that, we are very open to the portfolio acquisition. We are actively looking for portfolios to be acquired, especially in the hospital segment. In consumer health, we look for local brand acquisition opportunities. Thank you. I thank you for your attention, and I'm ready for questions if any.
Thank you, Satu. It's time for questions, and let's start with Iiris first because the mic is there. Then to Sami.
Iiris Heiman, DNB Carnegie. You announced a licensing deal with Amneal two years ago. How is it progressing and when will it be reflected in your numbers? Thank you. Yes, two years ago we made the deal with the U.S. company Amneal. They have a big portfolio in the US for generic products. We are really going through their portfolio and seeing one by one which of the products we could further develop to the European market.
Some of these products need some further studies or some actually quite often they require something. That is why it is so slow, if I may. However, we have been able to handpick there some of the projects and they are ongoing. I hope that in not too distant future, we are able to have first launches.
Thanks, Iiris, for the question. It is Sami's turn.
Sami Sarkamies , Danske Bank. I have two questions on Finland, which is a very important market in your segment. Firstly, can you comment on the competitive landscape? Secondly, do you see any upcoming regulatory changes that could impact pricing or competitive dynamics in Finland going forward?
Thank you. Yes, Finland is really the most important country for this business division, 60% of the sales coming from there. The competition, it is tough. There are all the time new competitors entering the market. However, there are also competitors which will be here only for a while and then they step out again. Yes, I would say that being number one, you are always the one who everybody wants to beat and achieve. That is why we need to really move faster than the others.
Yes, I see that the competition is getting tougher and tougher. Luckily, we are in the, we have a hundred years behind us. We are in a good position in that sense. The other question was about the regulations and everything. It has been lots of in the Finnish news and media in recent months and even years that what will happen, will there be some changes to our referencing pricing system? There are always these cost cuts what the government is introducing to the drug prices, for instance.
At least currently, my understanding is that this year is now quite secured. I do not foresee any cuts for this year. We are in constant dialogue with the responsible ministry. Other than that, there is also discussion about these OTC drugs, if these would be allowed to be sold in the retail as well. The ministry has divided these OTC drugs into three different categories.
The first one not requiring any advice, the second one requiring advice from the pharmacist, and then the third one being very, there are all the pain medications, for instance. They are quite, if not used right, can be even very critical and dangerous. I do not know yet. We will hear during the summertime what the government will say.
If we think about this first category where no advice is required, if that part goes to the retail, actually in the pharmacy, that market is only something like € 40 million-€ 50 million. We know by experience from other Scandinavian countries, when that has happened, it's only about 20% of that market that will then go to the retail because of course it will stay in the pharmacy as well.
That just gives you some magnitude of what kind of money we are talking about and potential. Therefore, I'm not too worried. However, I want to say that we do believe that pharmacies are the right channel. They have the information and knowledge, and we want our drugs to be really treated with special care and for the benefit of our patients.
Thank you.
There's Anssi right behind you.
Yes, Anssi Rausch from SCB. A question on this direct-to-consumer sales channel. What kind of expertise is it what you're offering there and who or what is providing that? Is it just an information bank or what kind of knowledge? You mentioned that the sales channels are one of your growth initiatives going forward. Are you planning something new in this front as well?
It is really we have there some medical experts who write columns there and provide information, of course, the products what we are selling through that online channel. There will be all kinds of information shared what this customer group would require. We are in early days, so we will also develop it based on the wishes and requests by the customers. About the channels, yes, we are thinking about different things outside Finland. Trying to be innovative, but other than this online channel, I do not have anything to share at this point.
Okay, thank you .
Any further questions from the audience here in Helsinki? No, it seems that we have exhausted and we do not have any questions online, at least at this stage. Kind reminder to the webcast viewers, utilize the opportunity and send in your questions using the chat function. We can then address those in the final Q&A. Now it is time to thank Satu.
Thank you.
It is my pleasure to invite our next speaker, Mr. Niklas Lindstedt from our Animal Health Business Division. Thank you.
Good afternoon. It is my pleasure to be here today and talk to you all, tell you a little bit about our story in animal health. To go into the details or into the future of animal health, I think we need to take a couple of years back and look at where we come from. When you look at our history, clearly in 2019, 2020, we had a very solid companion animal business, which was totally located in Finland with our R&D fully integrated into Orion system.
All the parts of Orion, all the parts of animal health, were in Orion. In 2020, we had a big change when we lost the distribution agreement in Scandinavia. That sort of left us in a situation where what should we do next? In 2022, actually the acquisition of Innovet, VMD, BioVet in Belgium, France, actually put us again back on the market in animal health.
Of course, when you do something like that in an ever-changing world, in 2023, we had a real setback, not only because of the world situation where we could find that the war in Ukraine influenced the currency in certain parts of the world, which actually gave some issues around some distribution. At the same time, after the COVID, there was a total warehouse correction in the U.S., which had a big influence on our U.S. business.
That is why 2023 really was a tough year all in all. At the same time, we were looking at how do we integrate these two businesses? How do we make this one animal health inside of Orion Pharma? At that stage, we started off by building a new management team. We integrated the business, the sales.
We also looked at the R&D and actually have a fully integrated R&D team today. That is where we actually go forward from. In 2024, we were back on track. Now we are actually where we need to be to accelerate our growth going forward. If you look at the world, we have 13 captive markets. We are selling in more than 100 countries. A major part of our people are actually outside of Finland. Today, almost 70% of our animal health people are located somewhere else. 90% of our sales comes from outside of Finland, which means also that we really, as on Liisa's first slide, are really global. We are trying to do going around the world and how do we build from here.
When we then say that, okay, if we're looking at our market presence and our world presence around the world, how do we grow from here? First of all, the animal health market is still growing and it's been expected to grow for the next 5, 10-15 years. It's been a really hot market over the years. Of course, for us, it's been also a good thing, but also there's an opportunity to actually capitalize some of that growth going forward just from a market point of view. When we look at the two different businesses with Innovet and Orion Pharma, we have both companion animal and livestock products today, which actually gives us an opportunity to play in the whole market.
Even though today companion animals are growing a little bit faster, mainly because of certain Western world markets and some specific product launches around there, the livestock market is clearly growing because of protein need in certain parts of the world. As we are now looking at our presence in these markets and with our portfolio, which is very wide in all these different places, we have an opportunity to accelerate our growth going forward. What is also really unique for the animal health is, of course, the customer base is consolidating. It has been doing that for the past 10 years. I always ask myself, why is that? Why is it consolidating? What is the big reason for that?
My personal view, and I think that it's getting more and more obvious, is that because animal health is still a very loyal business, you have a customer relationship, loyalty with your partners, with your customers. Actually, you don't want to change that. What happens is that the veterinary chains have a loyal base, and that's what the consolidation is actually going after. It's the same when it comes to partners with distribution that you cannot really steal partners from specific markets, but you need to consolidate those. When we now look forward and we see what we already done today, we already have relationships both with partners and with customers, which goes decades away or decades back. Those customer relationships, we need to utilize and expand.
The other thing which is clearly coming forward is, of course, the pet increasing, especially in the U.S., in Europe. You can see the pet parenting and that's the usage of products. What we also see is that this is a consumer business, in a consumer where you actually are part of the wallet of the consumer. Inflation, different kinds of costs going up will actually limit how much money you will spend on your pet. Also, unfortunately, we have seen lately that the pet spend has gone up significantly in certain markets. That will clearly, of course, have some backlash on the growth potential. On the other hand, again, regulations in the different world parts are actually growing, which means that the competitive landscape is actually giving us more opportunities to be there.
Now being present in so many countries with our products and marketing authorizations will give us opportunities to actually utilize that growth. Everybody always asks me, where do we go with our R&D and what kind of things do we look at and where is the thing where we think we can make a difference? Of course, with the livestock portfolio, we do carry some antibiotics.
Now clearly we are focusing off to the reduction, the replacement, and the refinement. How do we do that? We already have some solutions with, for example, competitive exclusion products for broiler growing, which is giving the chick a healthy gut flora. That means that when the chick actually is born and does never see its mother, it will have an opportunity to have a healthy immune system and does not need as much antibiotics if it gets sick later.
Different kinds of education around that. Also, what we find around the antibiotics is that we're really focusing today on individual treatment, not mass treatment, which means that as we also have a big investment inside of an injection facility in France, that really is the future where we want to go with having injectable products which we can have in the livestock segment.
Anesthesia and pain management, this is clearly an area where we have been for a long time. As earlier was said, there's a lot of history in our company and a lot of expertise. This is something where we are also looking for new, better ways, both post, pre, and around the operation table of the animals. When it comes to generic developments, it's funny when you think about that.
I usually don't talk about specific products, but I can tell you that last year there were 25 new veterinarian medicines approved in Europe. Two of those were from animal health, both in the pain. I mean, it's clear that we're doing the generic development all the time, even though we don't make a lot of fuss about it. These things are, of course, today public and coming out from that point of view.
As everything else, when we're trying to develop something new, it's really all about convenience and administration. It's all about formulation, but also, especially in the livestock side, we're talking about future productivity because it's all about productivity and cost in the livestock. Of course, innovation. All we know that Orion Animal Health has been in the past one of the companies which is really focused on innovation.
We have had some really new innovative NCEs coming up during the past 10 years, 20 years. At the moment, we're expecting that next year we'll have a new chemical entity in the US market. That will be an opportunity for us also to show that we can actually grow through the innovation and the new opportunities. Of course, the generic development is still there. We will always focus on filling our pipeline and improving our products. That's something which will also take time to fill up the full portfolio. In licensing, one thing which is clear for the animal health side is that there has been a lot of long-term partnerships.
are not that many suppliers around the world, and we have some very good suppliers and partners which we've been working with for decades, as well as everybody around the industry. That means that is where we will look for a lot of new opportunities coming forward as well. Of course, at that time also, what we have done after the acquisition is clearly the cross-selling, both repatriation of our own products in France and also working with our new portfolio in Poland and in some markets where there have already been some sales. Really trying to integrate and be more self-sufficient in the markets. When it comes to inorganic growth and opportunities around that, for me, clearly the acquisition or the merger is all about strategic fit.
As we could see already from the geographic expansion where we are in all those markets, if there is an opportunity in the current markets where we're looking at, if there would be something which would fit nicely and fit right to our expectations, that's where we would go. Simply, our purpose in Orion Pharma Animal Health is to provide meaningful, compassionate animal health care that prioritizes the well-being of the animals and their caregivers. Thank you.
Thank you, Niklas, for giving us an update on animal health business. You all know how it goes. The floor is open for questions. Do we have any here?
Everybody's excited for René. Okay, Sami Sarkamies, Danske Bank. I want to ask you about the Innovet acquisition that was done a couple of years ago. Yes. Can you talk about the financial performance in, let's say, in the recent years? It was tough initially, but where are we today relative to the time of purchase when it comes to top line and margins?
My view at this stage, we actually treat animal health as one company, both the Innovet and Orion. Even though there are some ways, because it is so interlinked at this stage, it is very difficult to say what is the financial outcome of that. If I would say that 2023 was really tough, now we can see that when we actually started integrating more and more and the things that we actually combined give us really an opportunity to see that as animal health, we are growing. I believe that always when you do these kinds of big moves, you have to take two steps back before you can go forward. That is unfortunately what we had to do. Now I feel much more comfortable with knowing that what we're doing today is actually building the full animal health business. I'm sure somebody could calculate that, but that's not something which I follow.
Is it roughly in the same condition as at the time of purchase?
My argument would say it's much better. Of course, that's what I've been doing for the past year and a half. I hope that's the feeling they also have. You need to ask them that. I guess I'm biased.
Yeah. Okay, thanks.
Any further questions here from the live audience? No, you did a good job exhausting all the questions during your presentation.
Very good.
Since we don't have any online, you don't need to stay.
Thank you.
You're free. Okay. Then we can take a little bit more time for the final Q&A because we are a little bit ahead of schedule right now. Now it's time for the last presentation. Finally, we get into numbers. It's my true pleasure to invite René to the stage. Please, René.
Thank you, Tuukka, and good afternoon to everyone. I'll first start with the financial objectives that we set for the midterm until the year 2028. These are the same financial objectives as we've had already since the beginning of last year. There has been no update to them, but it's good to remind of how they look. The period is from 2024 to 2028, with the reference year being 2023.
Net sales, we have set the objective to grow with a CAGR of at least 8% and an operating profit faster than the net sales growth. From a balance sheet perspective, we have set targets of having an equity ratio of at least 50% and return on equity over 25%. The dividend policy is to have an annual increase in dividends with a payout ratio between 50% and 100%.
Now, if we look a little bit on the growth figures and how we've been doing against those targets, we've seen a decade of slow growth first here. If we look at starting from 2010, about GDP level growth. Of course, during the last years, we have seen an acceleration of that growth with the launch of Nubeqa, but also because of the other divisions growing very nicely. We reached EUR 1.5 billion net sales last year.
You could say that we have been going a little bit ahead of even our schedule. Now, just to illustrate what an 8% CAGR would mean if we continue with that average growth rate starting from the position of where we are in 2024, we would end up at around € 2 billion in 2028. This is not a new objective. It is just an illustrative calculation of how this will go.
As a reminder, the reference year is 2023. This is also showing just a very straight line calculation. Naturally, we have, as stated, one Nubeqa sales milestone left of EUR 180 million, which we have all estimated at 2026. That would mean that if we would add that on top, there would be kind of a peak year in 2026 going a bit higher than the average line.
Now, to capital allocation principles. We have been discussing this earlier. Also here, there are no major differences in how we allocate capital. Just to give a little bit more color on each of the areas. Number one is still internal R&D pipeline that we have been discussing a lot. Generally, we would expect a growth rate similar to net sales growth over the long term.
In the past, the percentage of net sales R&D spend has been between 10-12%. However, timing of projects can cause a variation. This is also good to understand going forward that we could go both above and below this general historical average rate. Dividends is definitely one big part of our capital allocation, as said, keeping them annually growing and a payout ratio of 50-100% of net profit.
We have an extensive manufacturing network, a supply chain, and there we also have maintenance investments, which of course are part of every year operations. We are increasing capacity as we need more capacity for growth. We have been increasing capacity for darolutamide. We have been increasing capacity for Easyhaler, and those will also be invested in going forward.
In the past, we've seen tangible CapEx levels into buildings and machinery being about 4-5% of the net sales. Now, if we look at the next few years, we see a slightly elevated level of CapEx because we have seen, as you also have seen, that the darolutamide growth has been quite fast, maybe a bit faster than the initial expectations. We are increasing also here investments to de-bottleneck certain production lines.
We also have quite large renovations in R&D and quality laboratory facilities within this time frame that will increase the CapEx. You might see levels which are closer to the 5% of net sales in this time period. It will a bit vary depending then on the project timelines and execution. In the long term, as we grow, we see that we should be getting scale effects and have a relatively lower level of tangible CapEx, so closer to the 4% level.
You also heard today a lot about in-licensing and acquiring commercial assets. This is something which is ongoing all the time in all of the business units. It is part of the process as well. Each case here is always valued separately. We do the business calculations, and they have to stand on their own as a product.
However, there's naturally synergies between products and the portfolios, which add on top of their single product business cases. Then external innovation, we do use also CapEx to extend our internal R&D. We do a lot of cooperation with BioVet, and you can see intangible investments also being made. This is typically at the early stage, upfront fees in terms of signing fees. There could be milestone fees.
Of course, if it ever enters the commercial stage, also royalties. Finally, M&As is in our toolbox. We also have all the time looking at strategic capability competences that we want to acquire, but with a very focus on our current businesses. It could be used in all of our businesses as well. Just to give a little bit of sizing on the capacity for M&As, we have very low leverage, as you're well aware.
This means that we have a lot of balance sheet capacity using numbers such as € 1 billion of new debt and 10% of new equity. With the cash flow we are generating, we would have € 2 billion of capacity. Naturally, there are different structures as well available. As we grow, this capacity keeps on increasing every year.
Now, going a little bit more on the numbers side, as discussed on the historical numbers, this just shows that the R&D spend has been pretty steady at 10-11% of net sales. Last year, a bit accelerating, so going to 12%. The rest of the CapEx has been between 3-8%, average 5.7%, and the tangible part of that, 4.3%, with the rest then being intangible, a lot of these license deals and so forth. A little bit more detail on the R&D costs.
This is looking at the different parts of R&D, which is now here divided into research part, so meaning really early stage, preclinical phases, and then development, which is clinical phase or very commercial phase development of products. Also you have the general costs here, which is kind of infrastructure costs that support all of the phases. You can see the growth in the last year has been fast, 16% CAGR from 2022 - 2024. However, if we take away the write-off that was used last year in 2024 of € 70.5 million due to ODM-111 being canceled, you can see the growth rate was about 10% CAGR. The largest growth here has been within the research part, so the early phase.
As you can see in the other material, there are plenty of projects in the pipeline, and there has been increasing as well. Biologics projects have been increasing in the pipeline, and those are a bit more expensive in the research phase than the small molecules. That is also one explanation of the 24% increase. Now that we have more biologics entering even a later phase of the research part, we see that also increasing the R&D spend also this year.
Of course, when it always comes to the rate of increasing operating expenses, our financial targets also give us the frame and at what pace in the end we increase them. Now moving to the other large operating expense area, which is sales and marketing, that has also been growing over the last few years with 15% CAGR.
Again, here we had a write-off in 2024 for commercial rights. If we deduct that, the CAGR was 10.3%, happens to be similar as the R&D, not by design, but by chance. If you look at the main drivers for increasing costs, it is to drive sales. We have been expanding Easyhaler in Europe. We also have other geographic expansion areas. We have opened in Japan all commercial operations during the last year.
You could say the sales and marketing should always be done in a way that it drives new sales and matching that pace and gaining efficiencies as we heard today. Of course, whatever we do in terms of decisions in investments, we are providing, of course, value generation for shareholders. That is, of course, the underlying theme. Depending, of course, you could do this in many different cutoff points.
Just looking at the last 10 years, the TSR CAGR has been very solid with about 50-50 coming from share price appreciation and dividends. Dividends, of course, are a big portion of the total TSR in our case. Some key takeaways of this very short financial update. We focus on long-term growth and value creation. We are in a growth mode. We are investing. We are very disciplined in how we use capital allocation.
You can also see there are multiple areas where we use it. We are investing a lot in many areas. Especially, of course, with the R&D spend, which is targeted to invest with the growth of the company. In-licensing is an important tool for us, both in the commercial sense of having ready products, but also in innovation.
Lastly, of course, what this aims for is that we are increasing our long-term cash flows, ability to pay dividends, and while we keep enough capital for investments. All this is, of course, enabled by the good growth prospects that we have. That was all for me today.
Thank you, René, for the briefing to us. At this point, I would like to invite all the presenters to join René on stage. You can also go there, sit down, and we can open the final Q&A session. In the beginning, I guess we could take first questions from the audience that are directed to René after his presentation. Then we can open up questions also to other presenters. Let's start with Anssi again because he's positioned himself well beside the microphone.
Yeah, Anssi Rausch from SCB. A few questions to René. First, you mentioned a bit elevated CapEx in the coming years. How much elevated in a ballpark?
I think as I said there, our historical CapEx has been between 4% and 5%. The elevated here means closer to the 5% than the 4.3% average. Around 5%.
Okay. The next one about Nubeqa. Can you remind us what was the maximum royalty rate to be paid to Endo? Or what is the range? Have you disclosed that one?
I have to look at Tuukka here. It's a low single-digit number. Constant low single-digit number.
Okay, that's clear. Finally, about the M&A opportunities. This is a familiar slide, this M&A firepower. What would be that kind of target that you would actually trigger this 10% new equity option? What would be so tempting target?
Yeah, I mean, targets, of course, sizes can vary. And of course, every case depends on the total value generation. It doesn't have to be one single target, which is of that size. It could be multiple targets. Most likely would be multiple smaller targets supporting the businesses. Yeah, across all the businesses.
Okay, thank you.
Thanks, Anssi. Then Sami had a question.
Yes, okay, starting with René here, a couple of questions. First, I mean, if we look at the net cash position and the dividend payouts, you have started to lower the payout ratio in the recent years. Despite a material increase in profits, your dividends haven't really grown that much. Is there a reason for you to start building some sort of a headroom? What are you kind of like planning to do with this cash?
Yeah, it's a good question. Of course, if you look at our capital allocation priorities, there are multiple of them. I think there as well, we are in an investment phase as well. Of course, we also need part of that capital to be for investments. Of course, if there are less investments, then we can look at that ratio again. Of course, we do have, as you heard today and seen, we have quite many areas that we see potential to invest. That is why we think we can keep both of the targets. We increase absolute numbers, dividends, but still we have that more flexibility as well in the payout ratio.
Okay, and the second question, okay, it was sort of already asked, but if we think about Orion potentially making one larger acquisition, what would be the motivation that what is it that you currently need?
Yeah, I think it's, of course, I will not speculate on what it could be, but I think you know our strategy basically is to expand in the U.S. I think commercial assets in the oncology space, those could be the areas. Also, I think to strengthen the European business that we have. We have in our base business as well, we're looking to expand into the big five markets even more than we are today. I think it could be in both of those areas in both continents.
Okay, thanks.
Then moving on to Iiris. Iiris has a question there in the corner.
Do you see that your R&D costs in the next, let's say, three years could increase above the historical level of 10-12% of sales?
It is definitely possible. I mean, if we look at our pipeline at the moment and if we are successful in entering the clinical phases and everything moves along, then yes, I think if we have success there, then yes, that could happen.
Does it mean that you would start phase one or two study? Yeah. Or phase three?
I think, yeah, I think OD is the best one to come. Yeah, you were talking about three years period, I understand. Yeah. If we think about our clinical pipeline at the moment, it is possible that we can make a start with phase three study. Let's think about both 212 and 105.
Of course, when at the same time I told you that in 2026 we have three new phase I studies starting and you put all together and you understand that then in three years' time we would have several phase II running as well as in a good situation also phase III. That means that of course the costs are then increasing significantly. As René said, everything is now based on success of our projects.
How big phase III study could you do by yourself? I mean in terms of EUR.
Yeah, I think it really depends on the total portfolio we have. We have a certain growth rate of R&D that we can do. Even though it would be relatively speaking growing above the historical average, we are also looking of course the absolute EBIT is what we have as objective.
The more that grows, the more room we can also have to do those phase three studies on our own. Of course, at some point those studies might become too big. You know, if you look at the way we want to drive the financial structure of the company as well. We look at partnering options as well to complement that.
Okay.
Yes, Anssi again. One quick question on ODM-105. At this point, do you think that you have to use or you want to use external advisory when you are planning what to do next after phase two?
Of course we use external advisors and vendors that help us in the evaluation. It is in a way part of our business model that we always use external advisors too and consultants. Yeah.
I'm just thinking about these costs, which were of course quite extensive naturally in ODM-208 back then a couple of years ago. Should we expect something significant or more like business as usual costs?
No, you are talking about 105 and development. Which cost? Development cost or commercialization?
I'm talking about this. I think you paid more than... Yeah, it was EUR 20 million when you were using external advisory.
Advisor, you know, for the deal.
Yeah, because you have been saying that you're thinking about partnering ODM-105. For example, ODM-208, of course, naturally generated quite significant external advisory costs.
Okay, you are talking about partnering negotiations. Yeah. All right. Thank you, Anssi, for clarifying. You know, we might think about many different costs here as we're talking about R&D and CapEx and all that. Yeah, you are right. We used an external advisor, you know, finalizing that deal. When we talk about ODM-105, I think we are still more in the phase of thinking, you know, market potential and using consultants and advisors there.
When the time comes to make a decision whether we partner or not, I think it is one possibility that we use an external advisor. It is case by case, of course. You know, the decision, first of all, as René said, whether we are going to partner, whether we can carry out the R&D cost by ourselves. Then case by case, you know, whether it is something that we will carry by ourselves, the licensing negotiations, or whether we will have an external advisor.
Thank you.
Hi, Sean Jeffries. For 212, obviously you are planning on keeping that wholly owned and that sort of spearhead into the U.S. as well. Cancer studies are notoriously more expensive than, for example, insomnia studies, especially when it comes to phase three. What's the level of confidence in being able to keep 212 wholly owned, be able to spend enough on the studies, then also market it yourselves in the U.S.?
Maybe I start and then Outi and René can continue on that one. You are so correct that cancer studies, especially with the big indications like prostate cancer, are very, very expensive. Thus we have Bayer and MSD as our partners. As discussed earlier today, the first indications for 212 are small indications. We do think that we could have that in our hands and carry out the phase three and even the commercialization.
There comes the next question, which is just that could you have it, you know, fully in your, or could we have it fully in our own hands as we hopefully would see that there is a bigger potential with combination, combining that drug to some of the existing cancer drugs. We need to consider, as I said, it's case by case, whether you would find a partner to do kind of a hybrid deal where we can promote in the smaller indications and then combine forces with the bigger company, you know, for the bigger indications. I think there are many variations of this theme, you know, that how you could eventually commercialize and develop such an asset.
Thank you.
All right. Any further questions from the audience now to all presenters? Sami still has a follow-up.
Okay, thanks. This may be to Outi, just like a general question on R&D strategy. You've been successful with small molecules, but why do you think you can be also successful in biological drugs where you don't really have deep expertise and background similar to competitors?
First, the way how we have now built R&D is that we try to have very strong target confidence for drug target confidence, I mean, for our all projects so that we have a solid scientific basis for the projects. The reason for that is that the probability of success increases significantly when you build a strong scientific foundation for your drug discovery.
When you have then identified a good target that you can be confident is a true disease driver, if you limit all your drug discovery to certain modalities, a lot of these targets will be excluded because with small molecules you can't target all targets and so on. For that reason, we chose to have also biologics in our toolbox. As I told you, we are moving to that situation that we need to have CMC capabilities in-house for biologics and so on.
This is the time when we have started to establish this biologics hub and find the best possible expertise inside Orion. We are answering your question that there is a reason to go for biologics to have success and a broad pipeline, and we just need to build those capabilities.
When we go to the place where actually the whole antibody therapeutic antibody technology was first invented, for sure we will find the best experts to work with us. I think that this strategy is working and we have already the first recruitments happening there, and it looks very promising. I do not think that it is rocket science. It is a modality which has been around, you know, more than two decades already.
We have even biosimilars in the field of biologics. As I said, it is only one modality. When we do this right and have those people who have the experience, I think that we are going to be successful. Okay. Then second question on ODM-105. It seems that you have not fully decided that the program needs to be partnered.
Can you explain how you would be able to take it to market as it seems to be like a cheap product? Yes, it's a very good question. We already talked about that, how the development program costs are perhaps lower in that area, insomnia when compared to oncology. It is the opposite then when we talk about commercialization and related costs.
This is exactly the reason why we are considering openly and talking about partnering option when it comes to 105. When we talk about 212, we are still thinking as the first priority to build our own oncology commercial platform. Oncology is, as said, it's an easier field perhaps to commercialize from financial perspective at least. For that reason, it's the major goal for us to commercialize our oncology products.
Maybe a third question. If we think about ODM-212, where you might kind of do the U.S. on your own, at which point would you kind of press the button to sort out distribution in the U.S.? That, would it be like after positive phase two readout?
I think that it's too late. I think that we need to be prepared and start to build the commercial platform for our oncology products a little bit earlier. When we talk about 212, I think that we have also options if it happens that phase two studies in combinations are going to deliver good results. We have also an option to do co-development programs with other pharma companies. That's also a model how you can go forward with the commercialization too.
Okay. Thank you.
Iiris ja Mandia Bikarnecki. Your study on pain failed last year.
Did you learn anything that you could apply to your upcoming projects in pain?
Yes, for sure. We learned a lot. I think that those learnings we can use particularly in the field of pain, but also I think that we can use those also in oncology and in general in drug discovery. One important point is that in that program, we did our phase one study here in Europe, and then we were planning to start phase two study in the U.S. I think that we have now prioritized to open INDs for our studies very early in the U.S., just to be in the discussions with FDA very early and let them in a way to be involved in the planning of our studies. This applies both, of course, pain and oncology. Yeah, always you need to learn from failures.
Yeah, that's true. You still find this area, pain, as a possible or possible research area in the future and that could lead to a phase three study.
Yes. We have in our research pipeline, you saw that we have pain projects there. You also certainly noticed when I showed the slide that those are early projects now in our pipeline. It was much more oncology projects in the later phases in the research pipeline. We are not expecting to have something in the pain therapy area in phase three studies, as you suggested, very soon. It takes time before we are there. We do not have even yet, you know, phase one or candidate nominations.
Could you acquire or in-license any molecules in pain?
We have done this kind of strategic decision in the company. I think that I can openly say that I already referred to that, that we prioritize oncology products for own commercialization in the same way we prioritize also oncology assets to be in-licensed.
Okay, thank you.
Any further questions here? Sean, please. Just one more.
On 105, when you think about where it could be positioned in the market potentially, obviously you have your sort of old benzodiazepines, then you have the sort of newer, more innovative Quvivic, for example. Where do you think it could sit in the treatment paradigm in terms of the patient population?
And you are now talking about general insomnia, also then subgroups there.
Yeah, so general subgroups, yeah.
Yeah, yeah. At the moment we are doing the development program for general insomnia because usually that's something that regulatory bodies also favor, that you first go for general insomnia and then only after you have shown efficacy and safety there you can go to those subpopulations. That's our understanding and this is the way how the program is built at the moment.
Got it. Thank you.
No more hands up here in Helsinki. We can turn to the online questions. Actually, now we go back to the first presentations by Liisa and Outi when we had to skip a couple of questions coming from the webcast. Some of them have been already answered, but let's start, Outi, with you. This question may have some misinterpretation about the mode of action of Opevesostat, but of course you can then explain it. Can you talk more about Opevesostat? How does this antibody differentiate from those already on the market? Opevesostat is not an antibody.
Exactly. It is a small molecule and it targets CYP11A1 enzyme, which is the first enzyme in the pathway of steroid hormone synthesis. In this way, when you block that first enzyme, you block the production of all steroids. There is no such drug in the market at the moment. Also, if there are any competitors, they are behind a lot. This is a first-in-class molecule that we have.
Yeah. Maybe could you elaborate then in this field how, for instance, Opevesostat differs from enzalutamide or darolutamide, which are then targeting mostly testosterone?
Yeah, enzalutamide and darolutamide are actually targeting androgen receptor, which is a receptor for, for example, testosterone. Testosterone is, as we know, also a steroid hormone. There are also other steroid hormones. When prostate cancer cells develop, they can also modulate the expression and function and structure of a gene of androgen receptor. When that happens, these cells are not only growing because of testosterone, but because of other steroid hormones.
Now we have enzalutamide and darolutamide that can regulate this androgen receptor directly. With Opevesostat, we block the production of all the ligands that are able to trigger the activity of androgen receptor. This is the difference. Was it clear?
Thanks. You got it. Yeah, yeah. That was very, very clear now. Moving forward, there's one question referring to actually a question that was asked already here, but with the additional twist. Your internal R&D has been very impressive. Then again, the M&A and licensing track record has been more spotty. This refers now only to innovative medicines, not the whole company. Any learnings from previous setbacks, namely ODM-111 and then our collaboration with Marinus regarding Ganaxolone? What kind of assets would you look at going forward, late stage, early stage, whatever to maximize the likelihood of success?
The first thing perhaps to say is that in this business, I have talked a lot about attrition. Attrition happens for different reasons. You have problems related to the safety of the molecule, which are not target-related problems at all and issues at all. You have this problem of efficacy that even though all the experiments show that your molecule should work in this disease, when you go to humans, those models, those preclinical models are not translated and your project fails. All these factors are also, of course, embedded in the projects that we in-license. They are not only risks that are in our in-house projects.
Even more perhaps, when we do our in-house R&D, we know exactly how well we have validated our molecule, how well we have studied safety in preclinical models, in in vitro models, and in different platforms. When we do in-licensing, our visibility, even though we do DD, is not the same to the project. Perhaps in those cases, the likelihood for failure may be even higher.
Still, almost every company who wants to have a broad research pipeline and continuous flow of several clinical projects, as Orion wants to have, we are not a startup. We are a mid-size pharma company. They use in-licensing also as a tool because not all wisdom is inside our R&D. I think that we and everybody need to just understand that the risks are there.
I do not, I can always afterwards, I can learn from failures, which is always important. I can also easily say afterwards, what was in a way the problem. You know the problem. I think that there is no such an answer that I could say that we have failed in our MFAs or in-licensing because we have not done so many. What is the likelihood that our project is successful? Less than 10%. It is the same likelihood in our MFAs and in-licensing approaches. When we have done only a few and they have failed, it is not against the odds.
Thanks. That is clear. We also have one question that came during Outi's presentation. This is directed to you, but maybe also Liisa and René can step in if needed. Thanks for sharing impressive perspective. How do you plan to manage sudden sales or market volatility and supply to come as close as possible to growth opportunities? If we are talking about supply in innovative medicines, that must mean Nubeqa currently.
I think especially if we talk about Nubeqa, which is on a high growth rate, we of course have a constant discussion with our partners. We know where we go. During the past year since the launch and before the launch, we have been investing a lot to the capacity both in Fermion and in Orion Pharma manufacturing. We are still investing more to that capacity. I think we are well prepared to the higher growth rates as well.
Thanks. Thanks, Liisa. Continuing with Outi, this question. I noticed in your early stage pipeline that you have many projects focusing on bispecifics, ADCs, and one CAR-T program. These modalities have had great success so far, but therefore also become very crowded fields in oncology. What do you bring to the table in these programs? Are they new targets, new payloads? What's kind of the edge there?
When it comes to bispecific antibodies, it's targets. I can't reveal now the targets that we have for those programs that I said that will be in clinical phase next year. We have their first-in-class bispecific. Bispecifics as a modality is something that many companies use nowadays. It's very popular and it's working very nicely. I think that it's here to stay. It's about targets. It's about innovation that we are talking about. When it comes to ADCs, we have seen already now Orion started ADC research in 2020.
We have seen during that time when we have been in this field how the first generation ADCs have had many, many problems related to the toxic effects of the released payloads. We have been watching that. We have been learning from those first generation ADCs problems. We believe that we have a unique linker payload combination combined with good targeting antibody. We will have in our hands the next generation ADC, which is effective and safe.
Thanks. We will have something to wait for and expect when we finally then go to clinic at some point. All right. We have one question that actually goes to how. You basically answered this question already during your presentation, but maybe it is good to remind because we have this question here.
Is your Parkinson's portfolio, as it is currently set up, able to grow going forward? Considering entacapone products are to stay constant in sales, or what is going to drive growth? Is the growth coming mostly from new in-licensed products and developed products and so forth, or is the current portfolio also capable of growing?
Yeah, as I already answered early on, we do not necessarily break these down, but we believe there are synergies to be had. Collectively, hopefully, it will be a positive trend.
Yeah. All right. Thank you. Now we have exhausted also all the questions coming from the webcast. Now, still, anybody here in the audience? Any final questions? Answer. Go ahead, please.
One more question regarding ODM-209. Phase one is done. Do you think that there could be an actual use case later, or how do you see the future of this molecule?
The future of that molecule is in MSD's hands. In a way, it's difficult for me to speculate anything about that, whether they want to go forward with that molecule. It's totally in their hands.
Okay. Thank you.
You can easily check also, you know, patent time and so on. Try to speculate in your own head how.
Maybe if I may add here that now since MSD has started with Opevesostat, also these new trials probably send the message that they are now committed to take Opevesostat forward with full speed.
All right. Any other last questions here? I see that nothing is coming either from the webcast. Now it's my time as the host and moderator to both thank all the presenters, all the audience here in Helsinki, all the viewers on the webcast. I'd like to still hand over one more time to Liisa for the final words.
Thank you, Tuukka. Of course, on my behalf and on behalf of my whole team and Tuukka, thank you for spending the afternoon with us here in Helsinki and online. I hope that you have had answers to your questions and we were able to share a bit more depth and width on our business divisions. You see that we have a clear vision to future based on our solid financial track record and very robust business divisions to which we can build growth by innovation. Thank you very much. Have a nice day.