Good afternoon, ladies and gentlemen, and welcome to Orion's earnings conference call and webcast for the financial period of January-December 2020. My name is Tuukka Hirvonen, and I'm Head of Investor Relations here at Orion. In a few moments, our CEO Timo Lappalainen will present the results, after which you will have the opportunity to ask questions either from him or from our CFO Jari Karlson. We will first take questions from the conference call lines. After that, we will then read questions which we have received through the webcast tool. You see on the bottom of the screen a form where you can type in your questions. We will read those after we have finalized with the teleconference lines. We kindly ask you to state your name and the company you are representing before asking your question. Just before I let Timo to step in, I'd like to take a moment for a short commercial. Orion is holding Capital Markets Day this year on May 26th, here in Helsinki. Even though we so much would like to see all of you face-to-face, due to the COVID-19 pandemic situation, we are not able to do that, so the event will be fully virtual. Further information will be available later on, but you can now pencil in the date to your calendars if you're interested in attending the event. Finally, just a disclaimer regarding the forward-looking statements. With this, it's my pleasure to invite Timo on the podium. Timo, please. Thank you, Tuukka. It's my pleasure to discuss the highlights for the past year. Of course, what else could we start with than COVID-19? The three points that we've strived for the entire year was naturally to secure the continuity of our operations throughout the company. That meant that we paid specific attention to the health and safety of all Orionees and also the patients who were enrolled in our ongoing trials. That was the foundation, how we were able to maintain the continuity of operation. Due to the hard work by Orionees, our partners, there were no material disruptions in terms of the availability of products starting or raw materials. When we look at what was the bottom line of the year in terms of the financials, we saw that there was the increase of demand of certain products. We saw, of course, the decline of certain products due to the COVID situation. In overall, the net result was satisfactory. Of course, when we look at the impact of the COVID, the operating profit would have been roughly EUR 40 million or so lower than what we thought in the beginning of 2020. The board is proposing a dividend of EUR 1.50 a share to the forthcoming AGM. Of course, in R&D, that's the future lifeblood of the industry and also for Orion, we had a setback where our ALS trial did not meet its pre-specified endpoints. There were no safety concerns to the compound either, which is also marketed under a different brand name for a different indication. We were happy to announce a new leader, Professor Outi Vaarala to lead our R&D organization. She has taken swift action also to make sure that we will continue to have a progression in our clinical trials and in early pipeline. The key figures, the net sales were we had an increase of 3%, north of EUR 1 billion. The operating profit ended up at EUR 280 million, substantial hike from the 2019. Operating margin was we met our target that we've set ourselves or our financial goal of 25%, with 26%. Also we had a strong cash flow per share, EUR 185 with a 10% increase over the comparable period. If we look at the waterfall from the perspective of net sales, how those developed, we had a setback which was pretty even across the last year in terms of the net sales. There we saw EUR 16 million that we took a hit in terms of the net sales. Our products, Easyhaler continued to plow ahead throughout the year. NUBEQA, first time made to the top 10 as this was, of course, a little bit of a question for some of you, but with a EUR 14 million increase over the year, and this includes the product sales as well as royalties. We were able to increase our business in the reference priced market, which is one of the main market segments for us in Finland. In biosimilars, we lost some tenders in Scandinavia, and we informed you throughout the year that we expect the biosimilar business to be lower last year than it was in the comparable period 2019. When we look at all the rest of the products, there was a substantial increase in those. Our Fermion and contract manufacturing fared well last year. The royalties and milestones, excluding the royalties related to NUBEQA, that part of the sales contracted by EUR 7 million, and that's how we ended up in north of EUR 1 billion. When we look at the operating profit, certainly, of course, the volume, that was product volume, the major factor plowing ahead our sales. The margin product mix, how that varied had a positive effect. The exchange rate, so we got burned EUR 16 million in sales and roughly EUR 14 million in operating profit. Milestones certainly had an impact as well. The fixed cost, of course, we saw that especially in the beginning of the year, we saw a decline in fixed costs because there was less operational activity. That's how we landed at EUR 280 million for last year. Happy to note that when we look at the sales, no major changes. Finland plowed ahead in a difficult environment, very volatile environment. Scandinavia reached a plateau, we'll discuss that a little bit more, in very exceptional circumstances where the biosimilars took a substantial hit. The rest of Europe certainly fared well. North America, the decline there is mainly due to the NUBEQA milestone that we recorded in 2019. The rest of the world, many things going on, of course, in that there. Happy to note that all our businesses, they all reported growth, be that specialty products, our generic business, both in terms of prescription product, OTC products, and biosimilars. Proprietary products as well. Animal health had a strong year again, Fermion and contract manufacturing did excellent work also throughout the year. The league table of the products, Easyhaler, the entire product portfolio continued to grow by 10%, so two-digit number. Stalevo, Comtess, Comtan, our Parkinson's franchise, flat for the year. In SIMDAX, we saw a decline towards the end of the year. The patent expired, as we remember, at the end of the third quarter. dexdor, this certainly was different what was realized throughout the year, how we entered into the year, and we'll have a couple graphs on that. Animal sedatives had a strong year as well, number 10 make the league table is NUBEQA, and of course, the growth percentages are great. If we flip then to proprietary products, there, of course, the main new item is NUBEQA. Let's turn first to the old workhorses. Easyhaler, here you see the difference that the initial COVID did. That was for the first quarter when there was a hoarding effect, then we came back to the more stable growth path for the remaining of the year. Of course, in this, as we reported several times, the budesonide-formoterol, that has been the growth item that has been pulling the entire portfolio with it. The Parkinson franchise, and this, of course, today is a little bit more balanced in terms of what we do our own sales and how much we deliver to our partners across the globe. Today, Orion markets the Parkinson products by ourselves in Europe and also in certain Southeast Asian countries where we've taken over the business. Now it's pretty balanced. We informed and discussed that in the beginning of the year, towards the end of last year, there was stockpiling effect because of these changes of our partners, and then that took a toll when we moved to the latter part of last year. The story of dexdor, which is a sedative agent used in ICU setting, and this is the left-hand chart here. Here we really see the volatility of that for the first and second quarters when there was a substantial demand of the product throughout Europe. The situation calmed down a little bit for the third quarter, and we also saw many generic players in dexdor space having their capacity available. The second or third wave, depending how you count those, that hit again Europe, and we saw the increase of the demand of dexdor products in the fourth quarter, so towards the end of the year. In SIMDAX, here, as we started to move to the post-patent era, we saw the decline of the product, and this, of course, we've informed you duly how we expect this to develop. Moving on to our largest business, which is the specialty products, and that when we look at first the right-hand pie here, we see that Finland continues to be a substantial part of the business and had a nice growth of 3% there. Scandinavia suffered from the biosimilar business, but when we look at the business without it did a very good job. Eastern Europe as well as the rest of Europe showed growth for the past year. The COVID, of course, had an impact, but the biosimilars really took a toll because we lost some tenders. Here you see the more than 50% decrease over the 12-month period, which of course is substantial. On the other hand, then these businesses where there is more durability in terms of the prescription products or self-care products, there we saw healthy growth. To illustrate this a little bit more, we have here made a slide which gives you quarter to quarter, and of course, this has been presented to you, now it's just pulled together, what is actually the changes of the different parts of the specialty products. You see there the substantial decline of the biosimilars, however, then the prescription products as well as the OTC in overall continued to provide a healthy growth in the business. As said, Finland is by far the largest country market for our specialty products, and here in Finland, the market was more or less flat for the last year. We had a slight growth, especially strong for the reference priced market because that is the key market for us and the overall market was little bit on the negative side for the reference price market. The overall market, when we look at that, we continue to plow ahead, and as said, with the reference price market, we had a 25% market share. Here, the baseline actually varies from year to year. You have to understand that the baseline is calculated based on a certain point of time, which products are in this group. This group may change or evolve as the time goes by. In the self-care products, strong growth. We had a 26% growth, and in overall in the human pharmaceuticals, we had an 11% market share as we did last year. Moving on to research and development, and of course, what we are all looking forward this year are the results, the data of ARASENS, our darolutamide study, which we expect to report in the course of the summertime. We recently announced a new study for darolutamide aiming to the same patient group, however, with a different underlying treatment, ARANOTE, and that we expect to start recruiting still in the first half of this year. We continue to plow ahead with our 208, which is indicated for our study for prostate cancer. This is the CYP11A1 inhibitor, and here we are moving to phase II. From the same mechanism action, we have a sister compound, ODM-209, that we are studying for a little bit broader basket indications, including breast cancer, that's still in phase I. The Easyhaler tiotropium is in bioequivalence study, and we also informed that we are initiating a new dry powder inhaler platform development with the first new compound. As we did last year, we've now taken a practice that we give you as little bit guidance, how we think internally, what are the important milestones, events that we look at internally. Certainly in all of our ellipses, of course, the performance of NUBEQA, and here how we can do that is be a good partner with Bayer and do the co-promotion and see that the adequate patient population gets access to the product in Europe. As mentioned, the ARASENS trial results, those will be an important data point. That we get smoothly build up and start recruiting patients for the ARANOTE trial. Easyhaler, of course, we are pushing hard that entire product portfolio. As we said, we still have follow-up products to that, and we have a continuum to the entire Easyhaler platform. Then 208, we expect, as I said, to start to recruit patients to the phase II trial in that, and of course, we want to move that expeditiously forward. In Finland, this is the largest country market for us, so we are working hard to maintain and strengthen our market position as well as in Scandinavia to make certain that we grow our business in generic prescription product as well as in self-care. We are also investing a lot to enable future growth through an inorganic growth, and that, in our case, means in licensing new products. We do that all the time. That's our bread and butter in generic business, in animal health business, but here we make a reference to a little bit larger deals. Of course, we are evaluating also opportunities to get access to in-line products or through mergers or acquisitions. We are very strong in sustainability. We have a commitment to ensure the patient safety and of course, the reliable supply of medications. That's been paramount. That all starts with our responsibility for employees, the environment, the ethics, and the transparency of all our operations. Some of the key data from last year, some of the key indicators, how we look at the performance against our goals we put forth here, customer complaints, and this we measure as per million. We are at the same level as 2019, despite the increase in volume. We performed substantial number of audits. These are good manufacturing, good clinical, good laboratory-related practices, or even good distribution practices. Last year took a toll, and we were not able to do physical audits as we have had in the past. We are also working hard on the CO2 gas emissions with the scopes one and two and are making headway in there throughout also through the energy saving targets which we set for ourselves. Here we are in good path as well. We've had also a hefty target to reduce our work-related injuries, here this measure is per million working hours, the absentee days per million working hours. Last year, the number that we had on this same event was 6.6, that certainly was not a good number. There's still a lot of work to be done, we've improved ourselves, I'm very proud to see this number because it's been hard work throughout the entire organization. Of course, we need to operate ethically, the code of conduct training covers pretty much the entire organization. If we move on to ongoing year, so the outlook for 2021, we estimate that the net sales will be slightly lower than 2020. In terms of the operating profit, estimated to be lower or clearly lower than 2020. To give you a little bit background how we're thinking of this, we are putting forth here the key assumptions behind our outlook. Of course, the growth businesses are NUBEQA. We know that. There are other growing products that we've introduced in a generic space, of course, the Easyhalers, but we are going to see a lower number for milestones. We expect also dexdor to be lower than last year. Much will depend here how the COVID situation emerges out, but it is very unlikely that we will see such a surge as we saw in the beginning of 2019, as there are now product available. They are stockpiling in the countries. In terms of the SIMDAX, we are in the post-patent era now, and we expect those sales to be lower. In terms of the animal health, we informed last year that our longtime partner in Scandinavia decided to set up their own operation, and we lost those sales. The question mark that is on specialty products, we expect that to be lower. How much lower? How will that pan out throughout the year? That remains to be seen, but we expect that due to some of the hoarding effects that we saw last year, there is a possibility that some of that hoarding will, of course, not anymore, we will not see that. Will there be then the working down of the inventories in the countries? That is highly unlikely. Of course, it is possible, but we don't expect to see that this year. In terms of the profitability development, of course, the NUBEQA sales, that's an important driver there. The Parkinson franchise that the product rights that we acquired in Europe, we will not anymore have those depreciations in our books. Milestones, those flow pretty much directly to the P&L, dexdor and SIMDAX as well. Of course, the cost level. We are by no means giving up. We are plowing in full force ahead, be that in R&D or be that in sales and marketing. Of course, especially in sales and marketing, depending on the circumstances in specific countries. There are some countries where we can meet our customers face-to-face, but of course, in quite a few countries, it is virtual today. Of course, depending on the sales development of specialty products, that certainly, of course, will have an impact on the overall profitability. To assist you in looking at this year, we also put here a graph discussing the royalties and milestones, especially the royalties ex-NUBEQA that are ongoing business. Here you see the milestone impact from the various years of how that has evolved, and as we've said, that is substantially volatile component of Orion's final results for any given year, not to talk about any given quarter. We hope that these two slides open up a little bit our thinking here behind how we are looking forward to this year. Of course, the overarching goal for ourselves is the 2025 growth target with over EUR 1.5 billion. We're working hard to meet that. We think we have a very good opportunity still, despite the setback of the ALS compound or the ALS program. Of course, there's a lot that rests with NUBEQA, and there we've flagged already the important studies of ARASENS and ARANOTE. Easyhaler, of course, important part of the growth story of the company. The animal health continues to plow ahead with new product introductions. Of course, we are continuously looking also for opportunities outside Orion sphere for in-licensing or acquiring in line products. Of course, there are also challenges. We see that with some of the products, with the generic competition. There's the pricing pressure, which is a big question, of course, as we move on probably beyond 2021 to 2022, 2023, how Europe is going to cope with all the QE. We'll see that. Then, of course, for this year, the expiry of our Scandinavian distributorship agreement for animal health partner, that will take its toll to the top line. Then inherent risk, of course, in our line of business is always the success of the R&D programs. With these, I note that the AGM, we expect to have that on March 25th, and then the first regular update of the company situation in terms of the first quarter report is on April 27th. As Tuukka already said, please pencil in our CMD, May 26, and we will hold that virtually, so you will have an access to that without the need to travel. With that, I'll invite to the podium our CFO, Jari Karlson, to take any questions you may have. As Tuukka here said, we will first take the questions from the webcast lines. Once we've exhausted that, you can type your question to the question box, and then Tuukka will here moderate and read out those questions. Conference call first. Sorry, conference call first. Yes. Thank you. If you do wish to ask the question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Our first question is from Peter Smith of Bank of America. Please go ahead. Hello. Peter Smith from Bank of America. Thank you for taking my questions. On operating profit margin in 2021, can you give just some sense of the relative margins of dexdor and SIMDAX being lost versus Easyhaler and NUBEQA growing? Just any other points as you can for how we should be thinking about margin decline. On NUBEQA, the ARANOTE trial, what drove initiation of the trial? I know completion is in 2024 on clinicaltrials.gov, can we expect any interim readouts from that? Are there any potential plans to kind of further the trials of NUBEQA to expand its coverage of the prostate cancer treatment paradigm? Thanks. Do you want to take the first? I'll take the ARANOTE. Yes, I can start. Obviously, like we have indicated for years, dexdor and SIMDAX are the type of the products which are on the top ranking in terms of the product margins. When we lose sales in these products, it is very difficult to compensate with anything else we have in our product line. NUBEQA, of course, is different because there is the royalty component, when it comes to Easyhalers and of course the generic products and so forth, they will generate lower margins. Very likely the impact, especially on the product margins, will be negative as if SIMDAX and dexdor will decline as we currently expect. In terms of the ARANOTE trial, firstly, in the current protocol, there is no plans for the interim readouts. Of course, as I said, that's in the current protocol. The reason for setting up that trial is that, of course, we want to see that the product is made available to the treating physicians for different patient populations, how those patients are treated. There are some patients who are treated with both androgen deprivation therapy and docetaxel. Then there is a group of patients who are treated only with androgen deprivation therapy, and these depending a little bit on the patient category. That's why we wanted to expand also to have a trial where NUBEQA is studied against the androgen deprivation therapy. Having these alternatives that we can have for the patients for treating patients in a different manner, depending on the physician's preference. Whether this will drive into new treatment paradigm, I think one has to be careful here, but nevertheless, we are offering here a new treatment options for different patient groups, different patient populations, to the physicians. Our next question is from Sami Sarkamies of Nordea Markets. Please go ahead. Hi, thanks for taking my questions. I would start from the Q4 report. I think you raised the guidance ahead of third quarter results, and we're expecting about 15% EBIT growth last year, but now you have ended the year with only 11% growth. Can you elaborate on the reasons why Q4 came in below your expectations? Just looking at some of the sales areas, Parkinson's, SIMDAX and Easyhaler look clearly soft, while then costs may be on the high side. Well, in terms of the sales, there's always seasonality from quarter to quarter as we've many times have highlighted and I think many of these graphs that we also provide those show that there's seasonality in those. There was nothing specific, I think on fourth quarter in terms of the sales except for shipments moving here or there, something from the third quarter to fourth quarter and vice versa and for the next year. Nothing specific in terms of the sales. We saw in some markets really strong pickup towards the end of the year and some were softer, nothing that would highlight across the board even as per product. Also on the cost side, we actually were very happy to see that some of our R&D programs actually started getting speed towards the end of the year. I think from that point of view, the fact that we were able to spend as much on R&D as we did was actually a positive sign after a little bit slower period during the earlier parts of the year. Also I think it's fair to remember that the fourth quarter in 2019 was one of the all-time highest quarters in Orion's history. Only the first quarter in 2020 because of the COVID actually was higher. The comparison period to which the sales are compared in the end of the last year was very tough target. The sales actually were fairly normal level when looking at the product sales quarters we have experienced over the last few years. Okay, thanks. I would like to understand your thinking behind assumed cost structure this year. You're guiding for higher sales and marketing costs. What is driving this increase? Secondly, could you explain how R&D costs will remain flat as you ended the ALS study last year and the starting ARANOTE study looks smaller than ending ARASENS study? Okay, thanks. Very good questions. In terms of the sales and marketing, you may recall that we are actually co-promoting NUBEQA. Of course, we are taking our share of that part. When we compare that to the last year, we actually started the co-promotion effectively only in Germany. Towards the end of the last year, there were two other countries, including Finland. This year, we expect, of course, more countries to come on stream. Our planning assumption for the ongoing year is also that after the summer break, we'd be able to resume to more normal sales and marketing, whatever that might mean. At least it is more normal than what we are experiencing today. In terms of the R&D, whilst we expect to have the headline results in the summertime, unfortunately, from the financial perspective, the study still carries on which is good for the patients because there is still patients on the trial that we continue to monitor those patients. This is where we take account for the debts. Those costs carry on still for a period of time. Also, of course, the ARANOTE ramp-up starts this year. We will have a little bit of those at the same time in our books. In addition to that, we, of course, are now moving the 208 program to phase II, and we have now initiated some of the new Easyhaler related or respiratory studies. Even though none of those as individual studies as large as the ALS study was, but when you count all these together, they pretty much come up with more or less the same clinical trial type of cost than the ALS was. Of course, one needs to always remember that the clinical trials are not the only part of our R&D expenses. There is the infrastructure, there's the preclinical research. All of those contribute as well. That pretty much explains. In the sales and marketing cost, of course, one needs to remember that last year was not a normal year. The costs were somewhat artificially low because the activities were much below the normal level. The assumption now is that gradually during this year, we will get back to the normal level, which then, of course, shows up in the cost line as well. We're actually pretty excited that we have good investment opportunities in late-stage clinical programs as well as in early parts. We are pretty fired up on that. Okay, thanks. That's very helpful. On specialty products outlook for this year, can you still repeat why you were negative on that one? I think the message was also that you were not overly concerned with supply chain distortions, and you also made the point about non-biosimilar part of the business having turned a corner last year. That's true. Your notion of the biosimilars is exactly correct. We saw the big correction last year because we lost the tenders. There's still a little bit of a spillover for this year, but nothing compared to last year. The way we look at the specialty products business in overall, today, the way we look at the supply chain, we believe that we are fairly well-established at least for the first half of the year. Of course, this is all subject to that our colleagues remain and stay healthy. From that perspective, we think that is well covered. Of course, also last year, despite that we saw this hoarding effect, which by and large was a bump and then it leveled out. There were some countries who actually stockpiled material for forthcoming purposes. This is not really all that material, but of course, if you don't have this year, you're seeing this much last year and then this much this year, and then when you add those up, it adds up a little bit. That's one of the reasons for that. Okay. Finally, on the ARANOTE study that we discussed earlier, could you somehow explain how that broadens the market potential for NUBEQA, for example, relative to earlier ARAMIS or ARASENS studies? Just trying to understand what could be the patient population benefiting from this type of treatment path. We continue to be very careful here and can only refer to the Bayer's statement for the entire potential for NUBEQA exceeding EUR 1 billion. I'm sorry, but that's the arrangement that we have. Like Timo explained earlier, in the ARASENS study, we have a little bit different underlying treatments than now in the ARANOTE. Combining these together should kind of give data showing that more or less all the patients in that group can benefit from our product. Of course, from the ARAMIS, the difference is that this is the metastatic while ARAMIS of non-metastatic. There is this clear difference in the patient population. Okay. I don't have any further questions. Our next question is from James Vane-Tempest of Jefferies. Please go ahead. Yes, hi. Thanks for taking my questions, please. First one is just regarding your longer term EUR 1.5 billion revenue target. Just wondering how we should think about the balance to get there in terms of capital return and investment. As we progress over the next few years, I'm just wondering at what point Orion might have to decide if they're going to need to do more M&A to reach its target, and thus consider its dividend policy or maintain its current capital allocation policy. The second question is, what are your assumptions, please, on any changes on European pricing this year? What are you hearing from your country teams about the various European markets? The third question is, you mentioned about the depreciation of the Stalevo portfolio being a benefit in 2021. Please can you just remind us what that would be? Many thanks indeed. Thank you. The EUR 1.5 billion target and the funding to reach that. Far, when we look at the cash generation of the company, the payment of the dividend is not a cash flow issue. It is actually a balance sheet issue from the perspective of distributable funds. This is a little bit of a specific issue relating to the corporate law in Finland because you can only distribute basically a retained earnings, and not even all of those from the parent company. That is actually what is restricting the possibility of returning capital to the owners. Now we received a substantial win, a book gain when we divested the Orion Diagnostica and as we have now for the past two, three years have informed the market that we expect that there will be a bumps on our way to the EUR 1.5 billion. We can bridge that from the return of a capital from the perspective of dividends to the shareholders because we have this gain in our books. It is not a cash flow issue. It is more from the distributable equity, but even that we have bridged. Of course, should we make a very large investment, then we have to see if that has impact for the dividend paying capability. So far we're nowhere reaching that as of yet. Of course, then the other side of the coin is should there be other opportunities, be that in running late-stage clinical trial by ourselves, and potentially then gaining the fruit of that trial and those data and also with the upside, that of course would then eat in our annual profit that would then limit potentially our dividend paying capability. Anything you want to add on this topic? No, I think for the time being, as we see it, is that the M&A should not make that much difference in our capability to pay dividends. Of course, if the M&A results in a growing company, which hopefully then results in a growing profitability, it might have some impact on the payout ratio, which we have seen in the past by maybe lowering that a little bit. In the absolute terms at least, we are fairly confident that we can continue and over the time also grow even the absolute dividend. Okay. We had the second question on the European pricing scenery and what is our basing assumption. We are not aware as of today that there would be material system changes in any of the key markets important for us in the product categories where we are present. That we are not aware and as such, we have not factored those in. What we are seeing though, is actually we had two opposite effects last year. For Norway, we saw a couple of months a systematic change when Norway decided to increase the prices of generic products for a short period of time, for a three-month period, just to make certain that the country was able to access the product. Of course, it is fair to assume that COVID has had an impact on the timings of the reimbursement. As we've probably indicated earlier, we've seen delays in some cases in timings of reaching reimbursement. It has nothing to do with the data, but just the availability of personnel in the countries. I said, we are not aware of any material impact to our pricing scenarios. Your question about the Parkinson's depreciation and why that had an impact. We acquired the European rights for the Stalevo and Comtess, Comtan a couple of years back and depreciated that acquisition price over two years. That depreciation is now basically ended, which basically means that we don't have any more this roughly 1 million a month amortization of that acquisition any more this year. That has a positive impact of more than EUR 10 million on the EBIT line. That's great. Thank you. If I can just have a quick follow-up to my first question regarding the guidance. I understand it's not a cash flow issue and your 2025 target is a top line rather than a profit target. Clearly, investments can be made. I guess I was just curious in the release how it talks about investments currently being made will be delivering beyond 2025. Perhaps I can ask my question a different way, and that is what level of product acquisitions do you think the business can support at the moment so that you could still maintain the current dividend policy? Just to give us an understanding of the flex in the cash flow statement in terms of what you could potentially additionally require to maintain both as a balance. If I could also have a follow-up. Thanks very much. Thanks. Of course, one question is from the cash flow perspective that if we are able to acquire products or product portfolios or companies to that matter that are generating cash, then of course we always have the opportunity to raise cash through issuing debt. When you look at our numbers, we certainly have a debt capacity of several hundreds of millions that we could do. If then those acquired assets generate cash, I think we are okay from that perspective. The other side is, of course, that if we were to acquire or invest in product development programs that only potentially yield results after several years of development, and we have to contribute into those development efforts, that of course may be a different issue because that's then the P&L issue rather than the cash flow issue. I'm a little bit circling back to the same answer that from the cash flow perspective, as we have a substantial debt capacity that is untapped, we don't think that at least of the assets that, of course, we are interested in, that we would be hampered by our cash flow or raising cash funding capability from that perspective. Thank you very much. Our next question is from Jo Walton of Credit Suisse. Please go ahead. Thank you. I've got a few questions, a couple of financial, a couple of products, and a couple of strategic ones. Just starting on the financial one simply, you say that your CapEx is going to be higher in 2021 than the EUR 49 million that it was in 2020. On the cash flow, I can only find EUR 40 million in 2020. Can you just tell us what sort of things you'll be spending that money on? While we're on the cash flow, you've had two years where you've had working capital in at EUR 27 million in 2020, which is obviously very strong. With your growing business next year, particularly with things like NUBEQA, should we expect working capital to be a positive again in 2021? The final financial one is just if you can help us a little bit more on the gross margin as we go forward. You talk about operating expenses being broadly flat. I'm not sure, is cost of goods part of that operating expense, or is that seen as something different? My two product-related questions are just to get a sense of your enthusiasm about your tiotropium Easyhaler development. We can see that Easyhaler has been growing, but it's really been grown very strongly off your Bufomix, your effective SYMBICORT product. As far as I can see, the Advair product really hasn't taken off. Perhaps you could tell us a little bit about that. Given that that was your most recent Easyhaler launch, why should we think that your tiotropium Easyhaler launch should be materially different? My second product-related question is just the SIMDAX decline that we saw in the fourth quarter, which was about 30-odd%. Is that a good guide for the rate of decline that we should be experiencing in 2021? I have two strategic questions. One, if you could just help us on any level of incremental infrastructure you are putting in place to help you with the co-marketing of NUBEQA, whether the fact that you're being effectively funded by Bayer to be able to do that co-marketing, you're able to capitalize on that, and you're actually building your net infrastructure across Europe. The final one really comes back to questions that we've been hearing from others about your ability to do deals going forwards. I know you've talked about in licensing a lot, you've wanted to get products, maybe companies. In what you've looked at through 2020, because you've been talking about this for a long time and you haven't actually done much, have you found things that you've wanted to do, but they haven't met your stringent commercial thresholds, and so you've walked away from things you would otherwise like to have done, or have you just not found anything that you've wanted to do yet? Thank you. Okay. Good questions. All right. Okay. I can start from the financial ones. I was not quite sure about the CapEx question, but of course, typically there is a difference between cash flow and the capital expenditure based on the timing when you get the invoices in. We had a few in licensing cases towards the end of the year where the invoice actually came so late that we didn't pay yet those invoices in 2020. That explains a little bit of the difference why the investments were higher than the cash flow for the investment. That's kind of a normal and in the way how we report the cash flow statement, that's not included in the net working capital, but that is included in the investment capital expenditure cash flow part. The net working capital, yes, we are very happy that we have seen the decrease in the net working capital over the last couple of years. There are various reasons for that. Inventories have gone up, but on the other hand, we have seen a reduction in our accounts receivables, which is very much due to hard work all around the organization to collect money, get the customers pay on time, and so forth. Then there is a little bit more of a coincidence type of element that when do we purchase some materials, what type of non-interest-bearing liabilities we happen to have in our balance sheet at the end of the year. I think it's fair to say that we don't assume the same trend releasing tens of millions of working capital continues. We probably have done the easy part. One thing which might be beneficial for us in the upcoming year is the fact that if the COVID situation improves, we probably will not have the need to maintain as high safety stocks as we did last year. Coming to the gross margin. No, the operating expenses are not included in the gross margin. The gross margin development is probably in our case, more dependent on the development of the pricing environment in the market and then the product mix, and especially in the coming year when we see, for example, SIMDAX starting to face generic competition. The assumption is that we will see a fairly fast decline in the pricing of SIMDAX, which will then definitely hit more the gross margin percentage than would be only losing volumes of SIMDAX business. It's not a question of cost structure going up. Definitely, we are all the time working to streamline our operations. It's more the product mix and market pricing question, which is hitting the gross margin. Okay. On the future Easyhaler products on the tiotropium, we don't expect tiotropium to be such a big product for us than the budesonide-formoterol. However, we expect that to be bigger product than salmeterol fluticasone, so somewhere in that region. We don't expect that to hit such numbers than Bufomix at least initially. I think point well taken there. SIMDAX, what is the development for the ongoing year? Really tough question. What we've assumed is not too far off the mark, what you proposed here based on the fourth quarter. Really one should be really cautious with this because we don't know how many competitors, generic players, are able to firstly get the product approved or to get their supply chain ready, or how will they then price their products. That's a big unknown for us today. In how we substantiated the outlook for this year, you saw that we just put a negative number there. I think that's a safe bet, but anything beyond that is a pure guesstimate. I think the fourth quarter number is not a bad guesstimate. In terms of the infrastructure for co-promoting NUBEQA, there are I think at least one country where we are recruiting additional personnel because we had a very small operation in the country. In most of the countries, there is no material impact in terms of the headcount. In quite a few countries, we are retraining people. In some countries, there are some people who have left the organization, and we have hired oncology experts. In overall scheme of things, there is no really new infrastructure being put in, but your point is exactly correct. We are now focusing our capability towards the oncology. Of course, we expect the NUBEQA to be followed up by our 208 later. Then on the M&A or the targets, have we found anything? I think the point that you raised is extremely correct, is that we have very stringent financial criteria. Certainly there have been some cases where we would have been happy to be the new owners, but it was not a meeting of minds or we did not feel that comfortable with the valuations. We all know how the valuations have gone in the past then. We are by no means giving up. There are stuff cooking in the pipeline. We'll have to see if we'll find enough synergies or new thoughts how to develop these assets in our hands. Of course, one needs to remember that looking at the valuations in this industry, any meaningful size addition, whether it's purchasing of product portfolio or company, would very easily require EUR 100 + million, EUR 200 + million type of investment, which means that we anyway will not be able to do too many of those, which means that we need to be very careful that when we then decide to move, that we really find a target which fits our needs. Thank you very much. Our next question is from Julius Rapeli from SEB. Please go ahead. Hi, thanks for taking my question. I basically have two questions relating to the product. Firstly, on the Easyhaler product, you mentioned some lower activity during Q4 due to the COVID-19 pandemic. Could you give us some outlook for Q1 and how are things developing thus far? Maybe some expectations from the new pipeline product on the Easyhaler or the dry powder inhaler product that you mentioned in the report. The second question relating to the animal health business and relating to the Zoetis deal that you are now losing in 2021. How much do you expect the Clevor launch and the new deal with Vetoquinol to be able to offset the declines? Thank you. That's all from my side. Okay. I'll take the Easyhaler. The Easyhaler activity in the Q4, I don't know how much it was really impacted by the COVID situation. It was more of a seasonal effect that we saw the quarter-to-quarter variance. As we've announced, we expect the Easyhaler to continue to plow ahead. As was with the previous question, the budesonide-formoterol is certainly the product that is taking with it the entire portfolio. We expect that to carry on this year with the substantial growth in our books. With regard to the new invention for the dry powder technology, we really don't want to disclose anything on that in terms of the technology, it's still a few years ahead, it would not have any impact on the sales this year. Certainly, it will have impact on the profitability because we are investing in that in R&D and other capabilities for the new platform. In Animal Health, Jari is responsible for that. The Zoetis sales, of course, was a very large portfolio in Scandinavia, close to EUR 30 million in top line last year. It's clear that from the top-line perspective, the Vetoquinol deal is very different. We are there talking about one niche type of a product. In long run, we of course believe that the Clevor product is going to generate a lot of sales, but still it's very unlikely that any individual product in the near future will be able to compensate for the loss of this very large portfolio we had with Zoetis. Of course, one is to remember that the Vetoquinol is now only starting to launch the product. It gradually will take market, but it will take a longer period. The answer is that it definitely is not going to able to compensate as an individual deal. The Zoetis not in short term and very unlikely even in long term. It's very different type of an arrangement and considering only one product instead of a very large portfolio. All right. Thank you very much for taking the questions. Our next question is from Iiris Theman of Carnegie. Please go ahead. Hi. Thank you for taking my questions. I have still two questions left. Firstly, still on your EBIT guidance, I understand your EBIT could be down by 10% or even over 20% based on your previous guidances. The guidance range seems to be very wide. Could you give us still more color on that, and what are the main uncertainties or moving parts in your guidance range? Secondly, in terms of R&D costs for this year, do you have any other programs or projects ending than phase III for ARASENS that could decrease the R&D costs? Thank you. Some of the key elements for the EBIT or the drivers there, if one takes the product perspective, of course, is the dexdor, how that will pan out this year. Do we still see the continued demand on the back of COVID? Will there be other generic players in that space? We discussed the SIMDAX, how the SIMDAX generic competition will affect this. This would be, of course, one. Of course, is also if we see the buildup of the inventories for generic products in some markets, which so far we have not seen, if that takes place. Of course, fourthly the NUBEQA sales are important to follow for all of us. Those certainly would be some of the key elements how we look at this year. Also, unfortunately, gives a little bit broad range when starting out the year. Anything to add there, Jari? No, it's just that in all of those, there are quite a lot of uncertainty involved in dexdor because of the COVID and SIMDAX because of the competition which is not yet launched. We are only estimating when we will see the competing products in the market. Then, of course, NUBEQA is still only starting a journey in most markets outside of U.S. Even in U.S. it's in very early stage of the life cycle of the product. There are lots of these fairly big question marks, and that's why the range is relatively wide at this stage. In terms of some of the phase III studies that would be ending, the only one that we expect to have headline results this year is ARASENS. As I mentioned, the study is not ending, but the study will carry on. Other than that, we do not have any other phase III trials ending because that's the only phase III trial that we are currently involved in. There are no further questions at this time, I'll hand back over to the speakers. Okay, great. We have quite a few questions coming through the webcast. If I start to read these out in the order of appearance, the first one is regarding ARANOTE and ARASENS trials, how should we differentiate the trials, and what was the need to initiate the ARANOTE trial? Actually, Timo, you already answered that earlier, so I guess we can move on. We have a question from Anssi Raussi, OP Markets. What kind of progress you are expecting from NUBEQA regarding your 2021 guidance? Well- Growing sales. Yes, absolutely. Growing sales, but unfortunately, like I said earlier, we cannot really indicate anything more specifically because Bayer is the one responsible for selling the product in the market. Sure. Continuing with Anssi and ARANOTE questions. Could you give us any comments regarding the potential of ARANOTE phase III study on darolutamide? Well, as we discussed, it's a little bit difficult. This is a different treatment for the same type of condition of the patients, but for us, the physician has to make decision. We are comparing that to a different competitor. It would be unfair to give an estimate this year because we have to remember that we are not alone in the space. There are also competing products. This gives an alternative, and we can then demonstrate that the product has utility for the patients in different settings. That's really the purpose of that. Great. Continuing to ODM-208 with Anssi. He has couple of questions. How much it has cost so far, how much will it require R&D expenses in the future? Can you comment on the future potential of this drug at this point? We are currently ending the phase I. Typically without going into the program specifics, typically taking the product to phase I, you're roughly talking EUR 15 million-EUR 20 million over the life of the program. That gives you a little bit of the perspective. When moving on to this year, as we've discussed how we expect the R&D program to develop, of course, this will be an important part of our this year's R&D investment. It is too early to discuss about the potential of the product, and the reason for that is not that we want to hide anything, but the reason is that because only once we have phase II completed and we have genuine efficacy signal, and then we can develop the protocol for phase III, that gives us some indication of the potential patient population that would be treatable with this agent. Unfortunately, it would be far, far too broad a range to provide you any meaningful estimate at this time, because we know that we would be hanged with that. We rather defer that to the later date when we have some data to substantiate our thoughts as well. We have a last one from Anssi. Have you lowered your return on investment requirements or expectations when you look at the potential M&A targets? He's asking because our 2025 sales target is probably more dependable on M&A than it was before REFALS study failure last summer. Fair question. We have not yet, but we have to see when the opportunities present themselves. Of course, what we certainly will see that we want to see incremental profitability, but whether we can reach, at least in the short term, the return objectives that we set for ourselves, I think we have to be careful with that so that we will not destroy long-term value creation. The point well taken, and I think that's a fair point. Great. Going back to ARANOTE, this a question from name Sasma. "Hi. How will the ARASENS data to be read out this year impact the plans for the ARANOTE trial?" Probably how the ARASENS reads out, does it have any impact on the ARANOTE? No. These are two independent trials, two independent recruitment patterns. No, we don't expect anything from that perspective. Great. Moving forward, we have a question from Willis Hu from Sio Capital. "Can you please discuss why pension asset dropped to zero from EUR 55.8 million? Yes. We can. Yeah, I can take that. When the pension calculations are made, one of the main components is the discount rate used when discounting the future liabilities and assets. Because of the current ongoing very low interest rates, we lowered the discount rate quite a lot from last year, and that ended up increasing the value of the liability significantly. Actually, we now have an asset liability on the other side of the balance sheet instead of the pension asset we did have last year and the years before that. On the other hand, going a few years back, we had exactly the same situation when the interest rate started going down. This is not an unheard of situation, but really, the main explanation is the decrease in the interest rate used in the calculations. Okay. Thanks, Jari. Moving forward, we have a question: where do you see the biggest upside opportunity for the bottom line this year, and how large would it be? Without going into quantification, I think these four elements that we discussed that are the main drivers also for the broad range that we provided this year. That means the uptake of dexdor, how that will evolve, SIMDAX competition with the generic players, of course, NUBEQA sales, how those will evolve, not only in Europe, but also in the U.S., then the generic business, how that evolves. Those would be the key drivers, we can all speculate about the single or quantifying a single event of those are the four elements. A couple of more still. What would be needed to see share buybacks from Orion? Well, firstly, the board would need to propose that to the AGM, the AGM would need to take a pass a resolution on that. Currently we do not have that sort of authorization for the board. Lastly, we have a couple of ones from Diana Na from Goldman Sachs. On your 2021 guidance, could you perhaps be more specific around what you mean by lower versus clearly lower on operating profit versus last year? Judging by historical guidance issuances, the guidance seems to imply a -20% to -10% change. Is that the right way to think about it? Well, what we can say is that, of course, significantly is more than just without that prefix. We have never actually set the exact numbers. Of course, we also monitor as we go into the year, is that how our guidance reflects the consensus, not quarter-to-quarter. There are great variances and all of you analysts, you are doing a very difficult job, so we all have all the respect. I think so far, if we look at the outcome of any given financial year, actually the analysts, you, have been probably more often right than the company itself. Either the communication readout by yourselves has been excellent, or for some other reason, but you have been quite on the mark when we look at the consensus. Diana had follow-up: what are the main pushes and pulls to get to the higher end versus low end of the guidance, please? I guess we have covered that. Yeah, I think. Well- Yeah. I Yeah. I would focus on these four elements that we discussed. Yes, exactly. Last one is that, could you perhaps provide more color around the phase II trial design for ODM-208 and the specific target population you'll be testing? These are end-stage prostate cancer patients who would typically have multiple courses of treatment behind themselves. Other than that, I think we will be publishing the protocols and other data on the compound in the forthcoming months. Please bear with us. Thank you, Timo. We have exhausted all the questions through the webcast, and I will hand back to operator if there's any follow-ups on the conference call lines. There are no follow-up questions on the conference call lines. Thank you. Okay. At this stage, it is my pleasure. Thank you very much for extremely active questions. We will meet hopefully most of you in our virtual forthcoming CMD. Of course, shareholders, we hope you to participate virtually in our AGM, and then quarter one earnings call in April. Thank you very much. Everybody, have a safe day. Thank you.