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 usual.
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. Like I said earlier, we also have this time the opportunity to ask questions through the webcast tool. 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.
Before I let Timo to step in, I'd like to draw your attention to the disclaimer and the forward-looking statements. Without any further delays, it's my pleasure to invite Timo on the podium. Timo, please.
Thank you, Tuukka. It is again pleasure under these special circumstances, however, to discuss the first quarter results of Orion for 2020. If I'll first flag the highlights, what took place in the first three 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 pandemic, 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. 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. We've seen significant drop in patients enrollment in European clinical trials in 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 the 6th. Maybe 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 our Orion products that are currently marketed or for those study subjects that are enrolled in our clinical trials. We saw a very strong demand towards the end of March, especially in the space of generic prescription products as well as in OTC, pretty much across the geographies.
We expect that this hoarding of the medicines that we currently view will be then slowly expected to level off and that hoarding effect to melt down. To the effect of second half of March, so only a couple of weeks to the end of March, we saw a 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. We have seen 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. Those patients who've 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. This started already, of course, with the pandemic in the first country in China. 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 Orionees, including many our partner companies, be they our partners today in upstream or downstream partner companies. 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 meet the demand in the next few weeks' time. We have prioritized all our capacity usage for the most critical medications. As said, we cannot rule today that we will experience some delay in our research development programs. If we look at from the numbers perspective, the first quarter net sales were up 16%, operating profit even more so by 53%. A good operating margin at the 30% mark.
The cash flow was lower than previous year, this was mainly due to the working capital, especially the working capital tied into the receivables due to the high demand at the latter part of the quarter. The waterfall explains, 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 this quarter. The reason is that when we look at later, we had an exceptionally strong quarter for Dexdor a year ago, the comparison was really tough.
When we look at the Parkinson 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 right-hand panel, in operating profit. Clearly in operating profit, the product sales and the margin relating to the mix were the drivers of the business. The fixed costs a little bit higher than in the comparable period last year. The geographical breakdown, no major changes in that.
Across the board in all regions we saw strong growth. Of course the main regions here in Europe, Scandinavia and Finland all recorded strong growth. When we look at the portfolio the other way around in terms of the product wise, strong growth and 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. The best-selling pharmaceuticals, the league table certainly the Easyhaler is pulling ahead and had a strong quarter. 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. 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.
If we now look at the proprietary products and there the Easyhaler franchise had a strong quarter I said, for Parkinson and Simdax as well. The Dexdor was a little bit behind because the high quarter of 2019. Here we see 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 now for the first quarter. We have actually for the Easyhaler demand to meet that, we have put the line in full capacity usage for the online products.
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. That explains because in lieu of royalty rate, we get the full sales now and those we did very nicely on that. 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 2019, that was so far the highest ever. 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 said, the demand has continued very strong for Dexdor.
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 were successful in that. Scandinavia had a very strong month of March and the full first quarter and as well, the Eastern Europe. When we look at the split of the sales, no major change there. As we have flagged many times, it is the generic prescription products as well as OTC products that drive this business.
Biosimilars, whilst they were down for this quarter, their impact has always been much lower. The local market here in Finland, the market grew for the first three 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. With that, our market share in the reference priced business or that segment continues to be 27% in self-care products north of one quarter, and in the overall market, Orion's market share is 11%.
Here you see also the 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. The European approval came during the quarter, as well as the one in Japan. The rest of the programs, the prostate cancer for the late-stage patients as well as ALS, those are all running. The ODM-208, ODM-209 programs where we have the CYP11A1 inhibitor, those are also going to recruit patients for the next trials for the groups to study the molecule even further.
We informed that for ODM-203 and ODM-207, we are seeking for partners. The key business targets, and we took last year the approach that we tell also the external world how we rate ourselves, what are the important matters within Orion. 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. There we are well underway with the preparations and hope to see the launch relatively soon now.
Also the preparations for ODM-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. The local market here in Finland, we grew faster than the market in both reference priced products as well as in self-care products. Easyhaler, that's important, our largest franchise today, and it continued to plow ahead very nicely.
We see clearly that the COVID-19 has expanded the use of the product. 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 all organizations, including, of course, pharmaceuticals. 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've also taken extraordinary steps to ensure the starting materials, intermediates, as well as protective gear availability for our employees.
Of course, then ensuring that all study subjects in clinical trials can safely continue in the trials. We can do this only by keeping our employees and their families and close ones in safety and, of course, operating in as transparent matter as we can and, of course, taking care of the environment. We've taken many steps to ensure that the people at the shop floor or in laboratory environment or supporting functions can feel safe and are safe. With everybody, we've reduced the non-essential contacts and, of course, visitor bans and so forth.
Those are all in place. Our sustainability report will be published in the next few days, and there's a 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. For our regular reporting, the AGM will be held next week on the 6th.
We've announced that we hope that all the interested shareholders, they would utilize the link that we are providing to follow up the shareholders meeting and utilize the proxy statements that are available free of charge. 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. That's how we then continue the reporting. The half year report will be then towards the end of July.
At this stage, we open the floor for questions. For that, I invite our CFO, Jari Karlson here to the podium to join me.
Thank you. Ladies and gentlemen, if you do wish to ask audio question, please press zero followed by the one on your telephone keypad. Once again, to register for a question, it's zero followed by the one on your telephone keypad. There will be a brief pause while questions are being registered. Thank you. The first question comes from James Vane-Tempest from Jefferies. Please go ahead. Your line is now open.
Yes, hi. Thanks so much for taking my question. If I can, on guidance, please. If you're saying that there's a benefit due to hoarding 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. Secondly, I guess Dexdor is doing very well, as you mentioned. Can you remind us regarding IP? 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?
The final question is on biosimilars. Some of your peers are saying that some of the tenders have been delayed. Curious whether you're seeing this and what you're assuming for those in your guidance. Thank you.
Thanks very much. Yes, as we've explained, we expect that the hoarding effect, at least so far, that was a one-timer. We expect that dip sort of 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. 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. So far that has had no material effect to Orion's biosimilar business. Neither do we expect that to have.
Okay, thank you. Just the 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 like a single digit million-ish decline, whereas now you're basically saying that that gap's going to be filled really by those two products?
I don't think.
It's not due to cost.
I don't think we ever indicated in numbers what we meant by lower. As we've stated now, we expect the operating profit to be at a similar level.
Okay, thank you.
Thank you. The next question comes from Iiris Theman from Carnegie. Please go ahead. Your line is now open.
Yes, hello. Thank you for taking my question. Two 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? Secondly, the sales of others in the proprietary segment were 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? Thirdly, does this strong demand situation in Q1, is it going to have an impact on phase III for ALS?
Do you still expect the phase III results in early Q3? Thank you.
Do you want to take a couple first one? I can take the ALS question.
Yes. Of course, entacapone product family has been generic already for many years, and as a consequence of that, the underlying demand in the market is not growing. This is basically a timing question. Partly timing question related to the deliveries to partners, 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 hands the whole quarter, and that increased the own sales compared to a year ago. 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 speaking the rest of the product proprietary products?
Yes.
If it was that one, then Dexdor there, like Timo discussed during the presentation, the demand started picking up strongly during around mid-March. 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. 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.
At least now it seems that Dexdor sales definitely will be clearly higher than what we expected when we started the year. In the Easyhalers, the demand has increased. Of course, there is partly hoarding, but also a real increase in the demand of the product. There we also expect the sales to continue at a good level, probably this growth drive is not going to be as strong as during the first quarter when we had this much effect also in the Easyhaler. Precedex, very limited sales.
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. There we haven't really seen any real impact on the figures and are not expected it either.
If I may continue there, because the question related also to the others in proprietary products. That would include, there is a basket of I think four or five products in that, including NUBEQA royalties and sales of NUBEQA material to Bayer. That is included in that because it doesn't make the league table yet.
Yeah. It includes all the other proprietary products that don't hit the top 10 list of our best-selling pharmaceuticals.
The question on the potential delay of ODM-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. Also having access to the sites, what we need to have the access to do the quality control of the data. We have turned over to remote monitoring. A 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. 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 to follow up on the other sales. Can you still comment where did the main increase came from? Was it from NUBEQA?
Yeah, that was it.
Yes.
Last year we didn't have any NUBEQA sales at all at this stage. That of course was the largest individual growth driver in that segment.
Thank you.
Thank you. As another reminder, to register for a question, it's zero followed by the one on your telephone keypad. The next question comes from Sami Särkämies from Nordea Markets. Please go ahead, your line is now open.
Thank you. 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? 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. Where there is a risk, that is for some of the products that we buy externally. How material that is 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 strong shipments still in quarter three because of the backlog that we are now manufacturing.
Before it gets all released, we will be seeing to phase III. We expect that to run in terms of the sales at least to quarter three. Then what happens after that, I think these are the assumptions how we built our outlook and that's as far as we can comment on that.
And the.
Okay.
Yeah. One of the key assumptions really in the guidance was that our own manufacturing can continue supplying the products as planned so that people don't start getting sick and so forth. Like Timo already mentioned, we feel relatively good about the availability of raw materials and materials in our own production. 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, thanks. A follow-up on Dexdor. You are saying that you are not able to meet all the demand currently. Can you provide us some color on what is your current manufacturing capacity? 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 mil, 4 mil, or 10 mil products. They all have different line speeds, and we adjust that as quickly as we can. Basically, we've ramped up the production capacity to say to four-fold, that compared to the situation it was before the COVID-19 demand spike. It is running at the very high rate today. We have a backlog of orders that we expect to clear before the summer shutdown.
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. It was basically caused by that.
If you think about production capacity in April, it's four times higher than it was, for example, in January, and you have order backlog until the end of Q2, basically.
Very much so, yes. 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.
Of course, the demand is partly has been depending on our capability to supply, but of course also on the competitive situation. What is the real demand in the market, how long this very high level of demand will continue. There are a lot of uncertainties, and especially the competitive situation and the continuity of the demand, of course, are things that we don't really know at this stage. 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 then the patients require sedatives because they are intubated with the assisted respiratory function. 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.
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 use. In some countries, regulators have purchased the inventories of animal sedatives or have effectively confiscated some of those materials.
Thank you very much. I don't have any further questions.
Thank you. There appear to be no further questions. I'll return the conference back to you, speakers.
Okay, we have some.
We have some questions from the webcast. We start taking them in the order we have received them. The first questions are from Keyur Parekh from Goldman Sachs. The first question is related to the guidance upgrade last Friday. You've kept your revenue guidance of broadly 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? A follow-up for that, you talk 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 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 will slowly melt away. Furthermore, we expect that the Dexdor sales, whilst those are expected to continue strong, 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. That will sort of balance itself out in terms of the sales.
Naturally, when we are talking about the products that we produce ourselves, they are our own proprietary products, versus purely generic products that we get supplied from third parties, the margin impact is quite different. That's maybe in the nutshell. On the cost front, currently the estimate assumes that there is no major changes in the outlook for the cost structure of the company compared to the original estimate. It really comes from the fact that when you are producing your own products, and as long as you have the fixed cost base.
The only additional cost you actually generate in order to make those sales is the raw material part of these own products. That, of course, in the proprietary type of products, is a relatively small part, especially when compared to sales, and that drives the margins up.
We have couple of more from Keyur 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.? The second one is that now that the drug is approved in both Europe and Japan, how has the launch preparations gone, particularly in Europe, given the current COVID-19 environment?
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. Kindly contact Bayer in that regard. They had the conference call yesterday this morning, and I'm sure they can comment on that. Our preparations for Europe, we are plowing ahead. Obviously, in these circumstances, there is a high likelihood that we will need to go virtual here or remote detailing, at least in some countries where that is available.
There are also first signs of potential access to the customers in the next two months or so as these restrictions may be partially rolled back or lifted. We are hopeful that in some countries we can actually start meeting even customers. The preparations are underway for remote detailing. As said, in Japan, things are moving along, but obviously there we are not on the front line either.
All right. We have one more from Anssi Raussi, 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. Naturally, this is all new to everybody. We don't really know at this stage if remote detailing is actually more effective. Can we meet more customers in the same time slot? What will be the impact of those? Obviously also the many facets of the marketing material will need to be re-tailored for this remote detailing. I think nobody has any experience. We don't have anything to extrapolate that.
We are playing by the ear, and I think that would be too early or hasty to give you guidance on that. Either way, it's a good guesstimate.
Then we have three questions from Vera von Lode from Kauppalehti. 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? 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, seems like the demand is still very strong. That's based on the order book that we have. 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, that's a competitive situation. It's not emergency orders, we would expect that to be tendered out at least in some countries. Obviously, that remains to be seen how successful we will be in those tenders. In geographical growth.
It was very strong all around Europe. Most of our own sales are coming in Europe and the growth was fairly similar numbers pretty much all around Europe. 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. The last question was about the possible supply problem for the other products. Dexdor, in that product line which is producing Dexdor, we actually are producing relatively limited number of other products.
That as such doesn't really have that strong impact on the most of our portfolio. Of course, for those few products that are produced there, currently we are prioritizing Dexdor. For Easyhaler, that's basically a dedicated line which only produces Easyhaler, so that doesn't really have that much impact on the others.
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.
One final question from the webcast. When can we expect to see the NUBEQA sales being published? Thanks.
In Orion league table, we of course hope to have next quarter, so that the sales would make the top 10. That would be it from our perspective. The in-market sales, that is something that need 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