Good afternoon, everybody, and welcome to Orion's Earnings Conference Call and Webcast for the financial period of January-March 2022. My name is Tuukka Hirvonen, and I'm the Head of Investor Relations here at Orion. We will kick off today with CEO Timo Lappalainen's presentation, after which then we will arrange a Q&A session where also CFO Jari Karlson will be present. We will be first taking questions through the conference call lines, and after that, we will turn to the questions you may type to us through the chat function of the webcast on the bottom of the screen. We kindly ask you to state your name and the organization you are representing before asking your question. Just before I let Timo step in, I'd like to draw your attention to this disclaimer regarding forward-looking statements.
Without any further delays, it's my pleasure to give the stage to Timo. Timo, please.
Thank you, Tuukka. Welcome to our earnings call for January-March. It is a twofold event, of course, also for Orion. If we look at our lead growth product of Nubeqa, the growth is doing very well. On the other hand, we are seeing the war ravaging in Europe, causing various stresses to our supply chains. In R&D, we were happy to report the detailed results of ARASENS study in ASCO GU, including the world's most prestigious clinical scientific paper, New England Journal of Medicine. The results obviously were flagged then later also by the upgraded sales forecast or by our partner Bayer. We've also announced during the period that we are planning to refocus our R&D more on oncology as well as pain.
That will firstly take place in research, and then obviously as the time moves on, also have effects in development. Now, Nubeqa sales those we booked showed a strong growth in Q1 . We had a large product deliveries to Bayer, and I'll come back to that a little bit later on because there are some accounting issues here that we all need to be aware of. Also, Easyhaler performed very well during the period, and as we've noticed several times, and have noted all of you, that the Dexdor and Simdax declined as we expected.
Now, what we've seen in the operating environment is that the one of the results in purely in a business or financial sense is that the war in Ukraine has accelerated the underlying cost inflation, also increasing the supply chain risk, which today are combined also with the logistical issues that are being faced in China. Then while those all work down the chain, we'll have to see what is the impact of those to all the industries on all the companies, including Orion. That's partly also the leftovers that what we are seeing in COVID. As we noted early on in pharma, and especially in the business where you are mainly in prescription business, it is not easy to pass on the rising production cost to sales prices.
You are limited to either tendering, tenders, and tendering, or it's basically a reverse auction, or then you are administered a pricing system and you have to discuss with the pricing boards. Of course, the company was happy to announce successor planning had been now completed, or the first step has been completed by the board, and Dr. Liisa Hurme, whom some of you have known also because she has a long tenure with Orion, has been appointed to President and CEO effective first of November, and we all welcome Liisa to her new position. The key figures for Q1 . Net sales pretty much at par with last year, so EUR 271.
Operating profit a little bit shy of last year, also reflecting in our operating profit margin, still above our 25% mark, which is our target. Cash flow before the financial items a little bit higher than last year, which was a little bit slow from that perspective. Now if we look at the waterfall for the sales, what has changed now for only EUR 2 million, however, there are multiple, of course, points that affect to that effect. Simdax, Dexdor, we took a hit in that, and it's mainly in pricing for EUR 7 million. I f we look at the Dexdor, actually volumes are very stable or even increasing, and Simdax also very little volume impact. Nubeqa, going strongly as it should.
Also Easyhaler doing well and also the other products as well. Now, if you look at all the rest, t here was a decline partly relating to the animal health, and we'll talk that a little bit later on. On a Forex front, roughly EUR 4 million and also in milestones and royalties, and that ended up as said, pretty much at par with the comparable period. In terms of the operating profit, product sales, which those were higher. That's very positive news. Margins and, especially, the product mix, so that relates to the decline in prices, we've seen that. As said, the Forex, we took a hit then there. Milestones and royalties certainly higher than last year.
What we are seeing in fixed cost is that we are slowly starting to be in a more normal sense in a normal operating mode as far as the fixed cost base comes, but also there are some timing effects that relate to our clinical trial and that's how we ended up at 71. The geographical breakdown of the sales, Finland continues to be the largest country market, followed up by of course large European markets, Scandinavia as well, and then North America, where we do not have our own presence, commercial presence, so that's a partner country or countries, that is about 8%, and then rest of the world including Japan, roughly 15%.
If we look at the geographies, growth in many markets, Scandinavia pretty much at par, and then North America that really depends today on our shipments of our partner products, and of course Nubeqa there as well. How does North America perform in this graph. By the business lines, if we look at the specialty products, there was growth there as well as some proprietary sides. Both the human businesses we saw growth there. Animal health saw a decline, this relates to the timing of our supplies and sales to our partners. We expect that there will be catching up as we move towards the end of the year.
Whether that will be fully caught up, we'll have to see, but at least we will be catching that up. Then pretty much at par with Fermion as well. If we look at league table of products, Easyhaler had a strong start for the year and some of us we may remember that last year the comparable period was not very good, so but nevertheless we had a strong start for this year. Stalevo, Comtess/Comtan, our Parkinson franchise, pretty solid performance. Nubeqa, of course strong growth as this should be now number three product. Simdax saw a decline and then if we look at the Dexdor, also there the decline continued.
The animal sedative is now at number 9 position, and this is due to the timing of our shipments to our partners. If we move on then to proprietary products, here we see pretty much the numbers that we already discussed but moving on then to Nubeqa sales, as Orion books these and just a reminder for all of us the way this works, the way the math works is that when Orion ships products in Q1, that means Nubeqa products, those shipments or that invoice value is then deducted from the royalties in Q2 . That means that there will be some volatility in that overall income as we record both the product supply as well as royalties.
That volatility will be there, however of course all of us are looking at the trend line. On Easyhaler, we had a very strong growth and a strong quarter actually if one looks at even a longer period, the business is doing well in that front, and we see that the customers are in many countries back fulfilling their scripts, visiting doctors, and taking care of their asthma and COPD. Parkinson's franchise, this is the Stalevo, Comtess/Comtan, pretty much at par with last year. We see also there the quarterly volatility relates to the shipments of course to partners.
Sometimes we are even changing partners, so there are some inventory build-up or deep build-up of that, but then in overall, of course we are talking about the disease which is chronic disease p atients are well under control with a given medication, so this is a fairly stable business from that perspective. Now Dexdor, here we're seeing the huge volatility, the run-up in 2019, then another run-up in 2020 and 2021, and these last two ones were due to the COVID. As we've said that the Dexdor today has multiple generics in the marketplace, we are seeing less patients admitted to ICU, so that Dexdor is a product that used in patients in ICU setting. COVID does not help anymore that much.
Also, the generic competition, we have multiple offerers there. The price level have come down quite drastically. We are still pretty well holding up the volume. On Simdax last year, you remember that we estimated each quarter that there will be competition. If we look at the situation today, to our understanding in European key markets, we are having two generic competitors who are supplying the market. And thus, that means that still it is limited generic competition, however, there is a pressure on pricing by the buyers. That we certainly are seeing today. I'm moving on to specialty products. This is the business which includes our prescription generic business as well as our non-prescription business, meaning OTC as well as non-pharma.
The largest part of this business is in Finland, and we had a nice growth there. Scandinavia, the same thing, and also Eastern Europe and Russia. The rest of the world pretty much at par. If we look at the overall, both grew, the prescription business as well as the self-care products, and here you see also the split. About three-fourth i s prescription business, and then one quarter is roughly self-care products. In our largest market for the entire company and also for the SPB products is Finland, and there the largest segment is the reference price products. There the entire market for Q1 declined by five percentage points.
Orion, due to the volume growth, because here we see continued price erosion, the volume growth, we were able to increase our sales by one percentage point. When we look at the overall market, Orion continues to command 11% of the human pharma, and as said in the reference priced products, we hold 24% market share, and in the self-care, roughly 25%. I'll move on to research and development. How does the future key clinical development pipeline look for us? The ARASENS study that I mentioned in my opening remarks, that is currently in a regulatory phase in all the key markets and hopefully, in not too distant future, we will learn more about that.
ARANOTE, which is also indicated to the similar patient group, is well under its recruitment and is recruiting very well. ODM-208, which is for prostate cancer, there we've announced that we are in discussions for partnering that compound, and currently there are multiple discussions going on, but we do not have anything publicly to report at this time. From our own discovery pipeline, we have a compound in phase I, which is potential indication is in psychiatric disorders. As said, our largest franchise, so the Easyhaler for COPD asthma, there we also carry on programs. If we take the responsibility and sustainability in the times of severe conflicts, this is something that we will not forget.
This is part of Orion DNA. Of course, Orion condemns the war in Ukraine, conflict there, and invasion of the country. When we look at our priorities in sustainability, of course, the patient safety, keeping, making the product available also in the war-torn territories is something that we are working on, including through the NGOs and donating product to that effect. Taking care of Orionees, of course, that is paramount, and we are happy to report that so far all our colleagues in Ukraine, they are safe. This is something that, of course, our hearts go out to all of those our colleagues, their families, and others who are suffering from the war. Now, the environment is today ever more important aspect of any company.
We have very ambitious targets, including climate efforts for the climate, and we continue to work on that. Of course, given the environment where we are today operating, there may be hiccups to that effect. We haven't seen that yet, but we'll see how all the supply chains are able to cope and adjust to new environment. Ethical aspects today are very important. One of the parts here is naturally that as we work in pharmaceuticals are not sanctioned products. However, there are cases where actually logistics becomes very, very difficult. Today, of course, our aim is to keep our products in the market, and we are working heavily to making certain that also our supply chains can cope under difficult circumstances.
I'll move on to the business targets, and this is something that you remember that now we have for a couple of years, we've given you heads-up on the topics that give you a little bit perspective how we are moving towards our strategic goals, and certainly, of course, starts from the sales. The Nubeqa sales, how those are performing, that, of course, should continue on an accelerated curve, and this is today doing very well. Also, on Easyhaler, the sales are growing as they should because we have ambitious targets there as well. We are working on several discussions with licensing new products in different phases. Those are in progress, and we don't have anything to report on.
In a similar fashion as with the larger product acquisitions, do they take form of product acquisitions or M&A? It remains to be seen. As I mentioned, we are in the midst of discussions for ODM-208 for finding a partner for the development and commercialization of that product, and of course, here the commercialization, the key focus area here is North America. That relates also to kicking off the phase III program. Of course, we want to build and bolster also our clinical pipeline, and one of the targets is that we could add one new program to our clinical development pipeline.
That means also that we are actively looking for opportunities also outside Orion to continue actually our very nice track record in cutting agreements with many our partner companies. When we look at the financial outlook, that is the same as what we published in February, which was before the war broke out in Ukraine, and we are maintaining that. We estimate that the sales will be at the similar level as last year, and then similarly with the operating profit to be at the similar level as 2021. Now, the key assumptions that how we built our model for the year is, of course, Nubeqa is one of the drivers for both sales as well as operating profit.
Simdax being in the similar fashion driver, but on the negative side and how fast that will then take place is an important factor to look at, and Dexdor today, but to maybe a lesser extent. Cost inflation that we are seeing is an important part, and it is also cost inflation, not only to the material, it's to the logistics, it's just accessing the product, and of course, we need to be also due to the very recent events, we have to be also wary that we are monitoring, but nobody has a full visibility what will, for example, the potential disruption of the supply of energy, raw materials, feedstock mean to suppliers and that is something that will be difficult to estimate at this time.
Of course, we expect the price competition in generics to continue. We haven't seen that would stop or slow down. As I said, in business operations in general, we are slowly resuming to more normal levels, including that there will be more face-to-face, there will be physical meetings, there will be events, also to drive the business forward. Then, this year's scheduled events, the half year report on July 15th, and then the first nine months will be in October 20th. At this stage, I'd invite our CFO, Jari Karlson, here to join me to the podium, and we are happy to take any comments or questions you may have. As we all heard, we will take first the questions on telephone lines or live questions and then any that you want to type to the chat box there, and Tuukka will assist on those questions. Please.
Thank you. If you have a question, please dial zero one on your telephone keypads now to enter the queue. Once your name's announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial zero two to cancel. Our first question comes from the line of Harry Sefton at Credit Suisse. Please go ahead. Your line is open.
Brilliant. Thank you very much. Just two questions from me, please. My first question is on gross margins. You've been quite clear in flagging the squeeze on margins you're seeing with inflationary pressures. In Q1 , even if you adjust for the contribution from Nubeqa, you can see that the contribution to Q1's gross margin was still relatively high. I just wanted to clarify whether this is an accounting effect with inventories or whether you're seeing any significant mitigating factors in the quarter. My second question is on the Japan price cut for Stalevo. I think you've mentioned that you expect you'll be able to offset this price cut. I just wanted to clarify the exact timing to the price cut in Japan, the magnitude of the price cut, and then in what geographies you expect you can mitigate that decline. Thank you very much.
Do you want to take the gross profit?
Yes. Y ou already stated the key driver for the good growth margin was the fact that our Nubeqa royalties were clearly higher than last year at the same period. When that is adjusted, we are pretty much at the same level than last year. There, the key driver is that volume development in our sales, and as a consequence also in our production has been good during the first part of the year. When you have the fixed cost base and the volumes increase, that has a favorable impact on the growth margins. From that point of view, situation was relatively good and we had some headwinds in the exchange rates, but not that much yet.
The pricing and exchange rate headwinds had negative impact, but that was more than offset by the growing volumes and our margins. As a consequence of that, we were pretty much on par with the gross margin and then had the good royalty stream, which then improved the overall gross margin. It's of course clear that the cost inflation has not yet fully impacted our numbers during Q1 because most of the sales we did came from the inventories which had been manufactured already during the previous year. As the time goes forward, the higher material prices and other inflation items gradually start showing up more on the gross margin as well. It's both timing, but it's also the volume issue.
Okay. On the Japan Stalevo, that became effective to Orion in the beginning of the year. The overall impact of that, I think, we have not disclosed that, but in the overall context, it is still a few million, but we do not regard it as such a material event that we would fully disclose that. O f course, for Q1 , it was something that made a dent. In terms of making up for that, I think when we're looking at the Stalevo across the board, we would still expect that pretty much to be in overall Stalevo sales pretty much at par with last year. There will be some variation, difficult to estimate how the year-end deliveries go. The growth that we are seeing is actually ex-Europe pretty much, in Asia outside Japan. That's the main territory where we're seeing the growth.
Brilliant. Thank you.
Thank you. We currently have one further question on the phone. Just as a reminder, if you do wish to ask a question, please dial zero one now. That next question comes from the line of Sami Sarkamies of Danske Bank. Please go ahead. Your line is open.
Hi. I have three questions starting from Russia, where you booked a EUR 3 million provision. How are you thinking about continuation of your business and can you elaborate on any further risks related to this part of the business?
Okay. In Russia, I'm a little bit careful on purpose here, how we comment on Russia because I think many of us, we've been informed and we've read that we have to protect our colleagues there and we have to be careful how we address certain questions here. We are carefully analyzing the situation in Russia. I think we have the risks under control. There are risks, that there are always risks, but if one looks at the long history of Orion, I don't recall if we ever had uncollected payables there.
We do not have fixed assets in the country, no production assets. Our assets in the country are in the form of inventories and receivables, and of course there is some cash as well that you need to operate the company. We have roughly 100 people in the country, and our sales last year were in the ballpark of EUR 40 million in the country. Now, that was with the exchange rate that we saw at that time. Of course, the business environment has become very difficult in the country.
However, there are not only ethical obligations for pharma that you need to take care of certain obligations and deliveries to the patients, but we are also, in certain cases, contractually bound to deliver products and of course, those we need to then adhere to those contracts. Having said all that, the business environment is very difficult today in Russia and of course, the compliance matters are extremely burdensome today. There are various issues including logistical issues that are very difficult today to operate. I hope that you respect that if I leave it there.
T hat's okay. The second question would be on R&D refocusing that you announced in March. You'll be focusing on pain and oncology going forward. Can you open up on the practical implications from this?
Yes. Well, I think at the people level, the practical implication will be that there will be some shifts of people tasks. We are also in statutory negotiations with the employee representatives should there be any terminations relating to the contracts of the people, and we've estimated that there will be some. That will be something, but as I mentioned in my remarks, today the focus is really in the research. That means in the laboratory work, in the work before the clinical trials. There, we have good leads and good research programs in pain. We also have very interesting programs in oncology, b ut the CNS and movement disorders have proven to be a tough nut to crack.
There are maybe less opportunities at least for us in that space. Those are the reasons why we are focusing that work in the research. Before you would see that carried over to the clinical phase, that will take some time and I'm sure we will have some offshoots as well in the clinical where they may not fit exactly into these boxes for a couple of years' time. We will continue also, of course, in our development efforts in animal health as well as in our generic business.
Okay. My final question would be on high OpEx growth you experienced in Q1. Can you open up the reasons and comment the full year outlook when appropriate?
Well, maybe I can take that. From the sales and marketing side, t here was some growth, but not in percentage terms that rapid, and that is very clearly due to the opening up of the business. It didn't come from any specific one line item. A little bit more promotion, a little bit more travel, a little bit more personal cost, and so forth. It really came from all around the place. In R&D, we had faster growth and that was basically totally due to timing of some of the clinical trials we are having. One quarter to another, it's sometimes difficult to estimate and on the full year term, there we don't probably foresee any major change from last year.
This is more a timing question of the clinical trials. On the other hand, of course, the clinical trials are always somewhat difficult to predict exactly what will happen on which quarter. Also, on the administrative side, we saw growth and basically, there were two reasons. Some were just timing issues on booking of certain type of cost between the quarters. Another one to a smaller extent was related to the fact that we are now speeding up our new ERP system development and there is some additional cost compared to last year when that program was not yet running. Also , on the administrative side we don't see any major changes on full year scale from last year.
On the sales and marketing side, yes, we definitely expect to see also full year growth in that cost area because of the higher level of activity. Currently, the estimate is that during the rest of the year we will not see as rapid and large change compared to the previous year than we saw during Q1 .
Okay. Thanks. I don't have any further questions.
Thank you once again. If there are any further questions, please dial zero one on your telephone keypads now. T here seem to be no further questions from the phone lines at this time.
Thank you, operator, and this time we don't have any questions either from the chat line. I think if there's not any further follow-ups on the conference call lines, you may wrap up, Timo.
Well, thank you very much. Thanks everybody, thanks for listening and next time we will meet in July 15th and I welcome each of you to join the earnings call at that time. Thank you very much and have a safe day.