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[Foreign Language]Good afternoon, everybody, and welcome to Orion's earnings conference call and webcast for the financial period of January-March 2020. My name is Tuukka Hirvonen, and I'm the Head of Investor Relations here at Orion Corporation. As you can see, due to COVID-19 pandemic, we are at this time at studio environment, and we do not have live audience here present today. However, otherwise, the broadcast will go as usually. So first, CEO, Timo Lappalainen, will present the results, after which you will have the opportunity to ask questions, both from CEO, Timo Lappalainen and from CFO, Jari Karlson. I kindly ask you all to first state your name and the organization before you present your questions. And like I said earlier, we also have this time, the opportunity to ask questions through the webcast tool. However, we will first take questions through the conference call lines. And if we, after that, have enough time, then we will turn to the webcast questions. And before I let Timo to step in, I'd like to draw your attention to the disclaimer and the forward-looking statements. But without any further delays, it's my pleasure to invite Timo on the podium. Timo, please.
Thank you, Tuukka. It is again a pleasure under these special circumstances, however, to discuss the first quarter results of Orion for 2020. And if I'll first flag the highlights, what took place in the first 3 months this year. Obviously, based on Friday's release, you've all noticed that the net sales that we had for the first quarter, those increased fairly strongly due to the both hoarding demand relating to COVID-19 pandemia as well as the underlying growth that relates to the treatment of the patients who have been affected by the disease. With the growth of the volume, also, we saw the strong growth in operating profit. Then moving forward, darolutamide has received marketing authorization, both in Japan as well as in Europe. And there are quite a few other authorizations that have been received throughout this year and continue to be received. We are also noting that the COVID-19 has an effect on clinical trials, and there is a potential of delay of those. And we've seen significant drop in patients' enrollment in European clinical trials and overall. The AGM -- the Board first canceled the invitation for the AGM, and then the Board issued a new invitation to the AGM for the May 6. And maybe the interesting is that the proposal is actually the same for the AGM, including the dividend proposal. Now if we shortly recap the effects of COVID-19 on Orion, what are the key aspects of that? Of course, firstly, we want to focus on the safety of all the Orionees, their families, their close ones, the continuity of our operations. And then, of course, the patient safety, be that and online products that are currently marketed or for those study subjects that are enrolled in our clinical trials. We saw very strong demand at the -- towards the end of March, especially in the space of generic prescription products as well as in OTC, pretty much across the geographies. However, we expect that this hoarding of the medicines that we currently view that, that will be then slowly expected to level off and that hoarding effect to melt down. However, to the effect of second half of March. So only a couple of weeks to the end of March, we saw a very, very strong demand for Dexdor product, Orion's proprietary sedative agent. This came across all geographies, and we estimate that demand will continue strong in the next few months. Also, we have seen a very strong demand for Easyhaler products. We expect this to be also a function of COVID-19 patients, for patients taking care of their medications, probably in a better shape than normally. Also, those patients have both been affected by the lung infection related to COVID-19 are likely to need this product as well. On the other side, we see that there's a stress on global supply chain for pharmaceuticals. They started already, of course, with pandemia in the first country in China, then that has moved subsequently to other countries as well and also in logistics change. Now we've been very fortunate due to the [ horrendous ] effort and very heroic effort by many RMEs, including many, many our partner companies, be they at our partners today in upstream or downstream partner companies. And through that effort, we've been able to secure the supply of products, intermediates or starting materials and also protective gear. We expect that should there be disruptions to the supply chains, these are going to be seen towards the end of the year, and mostly relate to our generic business. Today, we cannot fully meet the demand of all the products, although we are making steps and expect to actually to meet the demand in the next few weeks' time. We have prioritized all our capacity usage for the most critical medications. And as I said, we cannot out-rule today that we will experience some delay in our research development programs. Now if we look at the -- from the numbers' perspective of the first quarter, net sales were up 16%. Operating profit, even more so by 53%. Good operating margin at the 30% mark. Cash flow, that we -- actually that was lower than previous year, and this was mainly due to the working capital, especially the working capital tied into the receivables due to the high demand in the -- at the latter part of the quarter.Now the waterfall explains, and I think the message here is very clear when we look at the net sales, it's really the strong growth across the board, with the exception of Dexdor for the -- this quarter. And the reason is that when we look at later, we had an exceptionally strong quarter for Dexdor a year ago. So the comparison was really tough. But when we look at the Parkinson's disease franchise, Easyhaler, other proprietary and also specialty products, very strong growth across the board. We took a hit on exchange rates, EUR 6 million in sales and a little bit more even when we look at the left-hand panel -- sorry, right-hand panel in operating profit. But clearly, in operating profit, the product sales and the margin relating to the mix were the drivers of the business. And the fixed costs are a little bit higher than in the comparable period last year. Now the geographical breakdown. No major changes in that. Across the board, in all regions, we saw strong growth. And of course, the main regions here in Europe, Scandinavia and Finland, all recorded strong growth. Then when we look at the portfolio, the other way around in terms of the product-wise, strong growth in specialty products, especially carried with the OTC and the hoarding of the medicines in the month of March. Proprietary products, pretty much across the board. Although as said, Dexdor, the comparison period was very strong last year. Animal Health also nice growth in that business. Fermion and Contract Manufacturing, almost at par compared to last year. Now the best-selling pharmaceuticals, the league table. Certainly, the Easyhaler is pulling ahead and had a strong quarter. Also Stalevo, Comtan, Comtess, our entacapone franchise for Parkinson's disease, this is the first quarter compared to last year when we had also the European rights with Orion. So that kind of explains partly of that. Simdax had a good quarter as well. Of course, products that are sold mainly locally because of the March effect. Now if we now look at the proprietary products, and there, the Easyhaler franchise had a strong quarter. I said for Parkinson's and Simdax as well. The Dexdor was a little bit behind because the high quarter of 2019. But you will see there really that the Easyhaler franchise is continuing to grow very nicely. And it's not only the budesonide-formoterol growth, but we also see the underlying growth of the rest of the portfolio growing very nicely, and now for the first quarter. And we have actually for the Easyhaler demand to meet that. We have put the line in full capacity usage for the online products, and that potentially will affect some of our development programs in Easyhaler. Parkinson franchise, as said, this is the quarter when Orion has the full European rights. And that explains because in lieu of royalty rate, we get the full sales now, and those we did very nicely on that. But also recorded nice growth in our deliveries to partners. Now the Dexdor story here in the left-hand panel, you see that the first quarter of 2019, that was so far the highest ever. And whilst the growth picked up in the first quarter, especially in the month of March, we were unable to beat that quarter 2019. But as I said, the demand has continued very strong for Dexdor. And Simdax also had a good quarter for starting of the year. Now Specialty Products. There, I said Finland had a very strong month of March, and we worked very hard to meet that demand, and we're successful in that. Also Scandinavia had a very strong month of March and the full first quarter and as well the Eastern Europe. And then when we look at the split of the sales, no major change there. And also, as we have flagged many times, it is the generic prescription products as well as OTC products that drive this business. And biosimilars, whilst they were down for this quarter, their impact has always been much lower. And the local market here in Finland, the market grew for the first 3 months, 8%. We were able to grow 9%. So we beat the market growth as we should because of our highest share in the reference priced products. And then with that, the -- our market share in the reference price business or that segment is -- continues to be 27% in self-care products, north of 1 quarter. And in the overall market, Orion's market share is 11%. And here, you see also the split, absolute split, of that business in the bar here on the left-hand panel. In R&D, the only change here we have is really the regulatory phase for darolutamide, which has been approved now in the U.S. and launched there. Then the European approval came during the quarter as well as the one in Japan. And the rest of the programs, the prostate cancer for the late-stage patients as well as ALS, those are all running. The 208, 209 programs, where we have the CYP11A inhibitor, those are also going to recruit then patients for the next [ Australians ] for the groups to study the molecule even further. And we informed that for 203 and 207, we are seeking for partners. So then the key business targets. And we took last year, the approach that we tell also the external world, how we grade ourselves, what are the important matters within Orion. And of course, the darolutamide, especially the commercialization in Europe, is very important because that's our first full platform for the pan-European-wide oncology product launch. And there, we are well underway with the preparations and hope to see the launch relatively soon now. Also, the preparations for 109, which is the ALS program, that study is fully recruited, and Orion is evaluating opportunity to launch the product itself. During the pandemic, we are obviously focusing on patient safety and making sure that the patients who are enrolled in study, they can finalize the study in a safe manner. Then the local market here in Finland, we grew faster than the market in both reference priced business as well as in self-care products. Easyhaler, that's important, our largest franchise today, and it continued to plow ahead very nicely. And we see clearly that the COVID-19 has expanded the use of the product. Then the in-licensing opportunities, allocating capital also to in-licensing opportunities or M&A. Currently, of course, the market is more or less frozen for those type of opportunities. Sustainability continues to play ever more important part for our organizations, including, of course, pharmaceuticals. And today, it is clear that ensuring the patient safety and the supply of medicines, those are on the top of every pharma company agenda. We were very well-shaped to meet the spike in demand here in Scandinavia and across Europe. We have prioritized our production capacity to meet the demand of the most critical products. We are fully utilizing our capacity. We have transferred people from other parts of the organization, be that in R&D, be that in commercial operations to support our supply chain and quality control operations. We're also taking extraordinary steps to ensure the starting materials, intermediates as well as protective gear availability for our employees. And of course, ensuring that the -- all study subjects in clinical trials can safely continue in the trials. And we can do this only by keeping our employees and their families and close ones in safety and, of course, operating in as transparent manner as we can and of course taking care of the environment. We've taken many, many steps to ensure that the people at the shop floor or in the laboratory environment or supporting functions can feel safe and are in safe. And we've -- with everybody, we've reduced the nonessential contacts and, of course, visitor bands and so forth, those are all in place. And our sustainability report will be published in the next few days, and there's a lot, lot more information in that report. On the outlook, on Friday, we upgraded our outlook. The net sales estimate, that remained the same. So we expect net sales to be at a similar level as for 2019, a little bit north of EUR 1 billion. On operating profit, there the new estimate is at the similar level as 2019, when the operating profit was EUR 253 million. And for our regular reporting, the AGM will be held next week on the 6th. And we announced that we hope that all the interested shareholders, they would link -- utilize the link that we are providing to follow-up the shareholders' meeting, and utilize the proxy statements that are available, free of charge. But as few people as possible would attend the AGM because that's the only way we can guarantee a successful conclusion of the AGM, including passing the resolution on the dividend. And then that's how we then continue the reporting and the half year report will be then towards the end of July. At this stage, we open the floor for questions. And for that, I invite our CFO, Jari Karlson, here to the podium to join me.
[Operator Instructions] The first question comes from James Vane-Tempest from Jefferies.
Just kind of on guidance, please. If you're saying that there's a benefit due to holding and stocking kind of Q1, just wondering what you're assuming for the unwind of that as we get into the second half of the year? And then secondly, I guess, Dexdor is doing very well, as you mentioned. But can you remind us regarding IP because I think there's some patents which go, I think, around in May time. So how should we think about the evolution of Dexdor in the second half of the year and into next year? And then the final question is on biosimilars. Some of your peers are saying that some of the tenders have been delayed. Just curious whether you're seeing that and what you're assuming for those in your guidance.
Yes. We -- as we've explained, we expect that the hoarding effect that was -- at least so far, that was a one timer. And we expect that debt somewhat to melt down in the course of the year. However, with the Dexdor and Easyhaler, we see continued strong demand, and pretty much across the board also for the others that there shouldn't be any setback in that. With regard to Dexdor IP, that has actually expired. So we currently do have several generics who offer Dexdor as a generic compound. With regard to biosimilars, yes, we see tenders, I think, across the board, not only relating to biosimilars but many others. Currently, it is the availability of products that actually counts for. But so far, that has had no material effect to Orion's biosimilar business. Neither do we expect that to happen.
Okay. And then just a final question then. I guess, the guidance looking at similar level of profitability versus lower. I remember there was some backs and forwards around at the time when the guidance was given in terms of lower. Am I right that I was sort of looking at more of a single-digit million-ish decline, whereas now you're basically saying that, that gap is going to be filled really by those 2 products largely...
I don't know. I don't think we ever indicated in numbers what we meant by lower. But as we have stated now, we expect the operating profit to be at a similar level.
The next question comes from Iiris Theman from Carnegie.
Few questions, please. Related to the organic sales growth in Parkinson's, was that more related to a positive timing effect? Or did you manage to reach any growth by your own actions? And then secondly, the sales of others in the proprietary segment, way up by around EUR 7 million year-over-year. Can you comment what was the main growth driver? And how did the sales of Precedex develop? And then thirdly, does this strong demand situation in Q1, is it going to have an impact on Phase III for ALS? Do you see the impact of the Phase III results in Q3?
You want to take a couple or first one? I can take the ALS question.
Yes. So of course, entacapone product family has been generic already for many, many years. And as a consequence of that, the underlying demand in the market is not growing. So this is basically a timing question, partly timing question related to the deliveries partner. And then, of course, the fact that a year ago, we were just taking over the European business from Novartis, and now we had it in our own hand, the whole quarter, and that increased the own sales compared to a year ago. So basically, it's just a timing element there. I was not quite sure about the second question. There was something about Precedex or was it generally in the rest of the sort of proprietary products? If it was that one, then Dexdor there, like Timo discussed during the presentation, the demand started picking up strongly during around mid-March. So that's one of the reasons why the sales were lower than in the very strong first quarter last year. Because during the early part of the quarter, the sales development was as it was during the second half of last year, so basically clearly declining sales. Now the demand is, at the moment, still quite strong. Of course, it's, at this stage, difficult to predict what happens towards the later part of the year. But at least now it seems that Dexdor sales definitely will be clearly higher than what we expected when we started the year. And in the Easyhalers, the demand has increased. Of course, they are partly hoarding, but also a real increase in the demand of the product. So there, we also expect the sales to continue at a good level. But probably, this growth is not going to be as strong as during the first quarter when we had this much effect also in the Easyhalers. Then Precedex, very limited sales. So the product has been generic for ages, and we only earn a very low royalty from the sales, done mainly in U.S. and in some other countries outside of Europe. So there, we haven't really seen any real impact on the situation. I do not expect it either.
In the -- if I may continue there, because the question related also to the others in proprietary products. So that would include -- there are -- there is a basket of, I think, 4 or 5 products in that including Nubeqa royalties and sales of Nubeqa material to Bayer. So that is included in that because it doesn't make the league table here.
Yes. So it includes all the other proprietary products that don't hit it the top 10 list of our best-selling pharmaceuticals.
Then the question on the potential delay of 109 program in ALS. That is a risk that we are currently facing. That relates mainly to the monitoring of the patients who are enrolled in the clinical trials. And also then having access to the sites, what we need to have the access to do the quality control of the data. And we are -- we have turned over to remote monitoring. A [ horrendous ] and heroic job was done by our people to organize that. And also with the help of many regulators because there are emergency guidelines having been issued so that you can implement amendments to the protocols in a rapid phase to secure the data quality as far as possible in the current circumstances. But there certainly is a risk that we will experience a delay. At this stage, unfortunately, we are unable to quantify that. We hope to have a better visibility of that for our next quarterly release.
Just a follow-up on the other sales. Can you still comment where did the main increase came from? Was it from Nubeqa?
Yes. That was the -- of course, because last year, we didn't have any Nubeqa sales at all at this stage. So that, of course, was the largest individual growth driver in that segment.
[Operator Instructions] The next question comes from Sami Sarkamies from Nordea Markets.
I would start from full year guidance. Just like to understand better the assumptions you're currently making. For example, if the strong demand for Dexdor and Easyhaler would continue also in the third quarter, will this trigger another guidance upgrade? And also, what about the supply chain issues you're assuming in the generics business? Do you have any visibility on these? Or are you just being prudent at the moment?
On the guidance on Dexdor and the other products, as I mentioned, we feel very strongly that we are well secured for the needs of our supply chain for the remaining part of the year. Well, there is a risk that is for some of the products that we buy externally. But how material that is, we -- or how will that materialize remains to be seen. We have been somewhat cautious on that. That is clearly the underlying assumption that we've taken. With regard to Dexdor, there will be a strong shipment still in quarter 3 because of the backlog that we are now manufacturing. And before it gets all released, we will be seeing to Phase III. So we expect that to run in terms of the sales, at least to quarter 3. And then what happens after that, I think these are the assumptions how we built our outlook, and that's pretty far -- as far as we can comment on that.
Okay. Then -- and one of the key assumptions really in the guidance was that our own manufacturing can continue supplying the product as planned so that people don't start getting sick and so forth. And like Timo already mentioned, we feel relatively good about the availability of raw materials and materials in our own production. But of course, if the epidemic starts growing in Finland, that, of course, might have consequences, which we have not now taken into account in our guidance.
Okay. And then a follow-up on Dexdor. You're saying that you're not able to meet all the demand currently. Can you provide us some color on what's your current manufacturing capacity that -- what kind of run rate on a monthly level you can currently achieve for this product?
I think that is a little bit irrelevant question because it depends on the capacity allocation and those we are pretty much doing online. That depends on the formulations that we run, that means 2 ml, 4 ml or 10 ml products. They all have different line speeds. And we adjust that as quickly as we can. But basically, we've ramped up the production capacity to, say, to fourfold that compared to the situation it was before the COVID-19 demand pike. So it is running at a very high rate today. And we have a backlog of orders that we expect to clear before the summer shutdown.
And the reason for the backlog really is that it took a few weeks after we started seeing the signs of the increased demand before the capacity was at full speed. So it was basically caused by that.
Okay. So if we think about production capacity in April, it's 4x higher than it was, for example, in January, and you have order backlog until the end of Q2, basically?
Pretty much. So yes. We will still -- we have actually delayed the summer shutdown until July, August in order to clear, from production-wise, the backlog. It will still be in the system before it runs through the pipeline through the quality control so that shipments will continue through September.
And of course, the demand, it partly has been depending on our capability to supply. But of course, also on the competitive situation, and what is the real demand in the market, how long this very high level of demand will continue. So there are a lot of uncertainties. And specifically the competitive situation and the continuity of the demand, of course, are things that we don't really know at this stage. So for our guidance is based on our best estimates on those things at the moment.
Maybe I can share some light or our understanding of the situation relating to the ICU usage of Dexdor. As the COVID-19 patients, typically they tend to spend quite extensive periods of time in ICU. And that -- then the patients that require sedatives because they are intubated with the assisted respiratory function. So typically, the sedative agents or like use of products is increased. And Dexdor would be in that category. So would be propofol in that category, and so would be midazolam in that category. And there has been a substantial shortage of all the sedative agents in Europe to the extent that in some nations, there has been clearly interest by the regulator to also use animal health sedatives for human units. In some countries, they've been -- regulators have purchased the inventories of animal sedatives or have effectively confiscated some of those materials.
There appear to be no further questions. I will turn the conference back to you, speakers.
Okay. We have some questions on the webcast. We start taking them in the order we have received, and the first questions are from Diana Na from Goldman Sachs. And the first question is related to the guidance upgrade last Friday. So you've kept your revenue guidance of profit flat versus last year, but raised your operating profit outlook. Could you perhaps give more color on what's largely driving the raise in the EBIT outlook? And a follow-up for that, you talked about some of the revenue dynamics, but any color you could provide on the cost front would also be helpful.
Okay. In terms of the net sales, the key driver for the maintaining the upgrade is that we expect the March effect -- I'll call it the March effect. We expect that not to be repeated. And we also expect that, that will slowly melt away. Furthermore, we expect that the Dexdor sales, whilst those are expected to continue strong, we are -- that the impact of our own products would need to replace some of the product shortages from generic products that we purchase from third parties, and that will sort of balance itself out in terms of the sales. But naturally, when we are talking about the products that we produce ourselves, they are our own proprietary products versus products -- purely generic products that we get supplied from third parties. The margin impact is quite different. So that's maybe in the nutshell.
And on the cost front, probably the estimate assumes that there is no major, say, changes in the outlook for the cost structure of the company compared to the original estimate. So it really comes from the fact that when you are producing your own products, and as long as you have the fees cost base, the only additional cost you actually generate in order to make those sales is the raw material part of these owned products. And that, of course, in the proprietary type of product, is relatively small part of, especially when compared to sales, and that drives the margin up.
Then we have a couple of more from Diana related to Nubeqa. First one is, could you perhaps comment on what the in-market sales were for the Nubeqa in the quarter in the U.S.? And the second one is that, now that the drug is approved in both Europe and Japan, how has the launch preparations come,particularly in Europe, given the current COVID-19 environment?
Okay. On Nubeqa sales in the quarter, in-market sales, there we refer your questions to Bayer, who are, of course, in the front-runner here and have the customer interface, so kindly contact Bayer in that regard. They had the conference call yesterday -- no, sorry, this morning. And I'm sure they can comment on that. Our preparations for Europe, they are -- we are plowing ahead. Obviously, in these circumstances, there is a high likelihood that we will need to go virtual here or remote detailing in -- at least in some countries where that is available. However, there are also first signs of potential access to the customers in the next 2 months or so as these restrictions maybe partially rolled back or lifted. And we are hopeful that in some countries, we can actually start meeting customers. But we are -- the preparations are underway for remote detailing. And in, I said, in Japan, things are moving along. But obviously, there we are not on the front line either.
All right. Then we have one more from [ Ann Serowsi, OP Markets, ] regarding Nubeqa. Do you estimate any significant delays in Bayer's Nubeqa sales ramp up due to the pandemic?
Well, it's probably yes, I think, to be fair. How severe those will be? Will those impact also competition? I think all that remains to be seen. But naturally, this is all new to everybody. So we don't really know at this stage if remote detailing is actually more effective. Can we meet more customers in the same time or same time slot? And what will be the impact of those? And obviously, also the many facets of the marketing material will need to be a retailer for this remote detailing. But I think nobody has any experience. We don't have anything to extrapolate that. So we are playing by the ear, and I think that will be too early or haste to give you guidance on that. But either way, this is a good guesstimate.
Then we have three questions from [ Behr Tickleberry ] First one is, how long can the positive influence of COVID-19 last when you think Orion's important products, Easyhaler and Dexdor? The second question is, where has the demand growth been the strongest in terms of geographies? And the third one is, now that Orion is concentrating on producing, for example, Dexdor, can that lead to supply problems of some other products, for instance, in Finland or elsewhere?
The COVID-19, what we are currently seeing is that at least the visibility that we have for the incoming quarter and maybe starting the next couple of months thereafter, it seems like the demand is still very strong. That's based on the order book that we have. So it seems to carry on. We expect also that to the latter part of the year, quite a few nations are taking steps to prepare themselves for the second wave of COVID-19, and that may result into the also stockpiling of the most critical pharmaceutical products. Of course, then that's a competitive situation. It's not emergency orders, but they will be -- we would expect that to be tendered out, at least in some countries. So then obviously, that remains to be seen how we will be -- how successful we will be in those tenders. In geographical growth...
It was very strong all around the year. So most of our own sales is coming in Europe, and the growth was clearly similar numbers, pretty much all around Europe. So of course, in numbers, Finland was the biggest because it's so much larger than any of the other geographies. But in percentage terms, very strong growth in all of the -- and the last question was about the possible supply problems for the other products. So Dexdor and that product line, which is probably in Dexdor, we actually are producing relatively limited number of other products. So as such, doesn't really have that strong impact on the most of our portfolio. But of course, for those few products that are produced there, currently, we are prioritizing Dexdor. And for Easyhaler, that's basically a dedicated line which only produces Easyhaler. So that doesn't really have that much impact on the others.
And we've obviously made an assessment on the prioritization and the potential shortages from the medical perspective, what are the most critical medicines. And for this, Dexdor clearly is one of the most critical ones today for ICU setting and that plows ahead.
And one final question from the webcast. When can we expect to see the Nubeqa sales being published?
In Orion league table, we, of course, hope to have next quarter so that the sales would make the top 10. Then that would be it from our perspective. Then the in-market sales, that is something that needs to be discussed with Bayer because they are the ones who have the ultimate customer interface. Okay. Seems like we've exhausted all the questions. I thank you very much for your interest. And looking forward to holding, hopefully, in a little bit different circumstances, our July earnings call. Thank you very much. Be safe. Thank you.