Good afternoon, and welcome to Orion's Q1 2026 results webcast and conference call. My name is Tuukka Hirvonen, and I'm the Head of IR here at Orion. In a few moments, we will kick off with a presentation by our CEO, Liisa Hurme, after which you will have the possibility to ask questions either from Liisa or from our CFO, René Lindell. We will be first taking the questions through the conference call lines, and after that, we will turn on to the webcast chat function. You may also type in your questions using the chat function of this webcast. To our Finnish-speaking viewers, this event is held in English, but afterwards, later this afternoon, you will find a Finnish interview of Orion's CEO, Liisa Hurme, on Orion's website. Just before letting Liisa to step in, just a reminder about this disclaimer regarding forward-looking statements.
With these words, I'd like to hand over to Liisa.
Thank you, Tuukka, and good afternoon on my behalf as well, and welcome to listen Orion Q1 2026 results. Some highlights from this Q1. All our businesses performed in a solid way and very well, I would say so. We also have good news regarding our clinical pipeline. We've been granted, ODM-212 has been granted Orphan Drug Designation in mesothelioma by FDA now in April. We also started a new phase I-B/II study called TEADCO, which is a basket trial evaluating ODM-212 in combination with standard of care treatments in patients with selected advanced solid tumors. I will talk more about that later on. Also, we have strengthened our executive team. We've appointed Mr. Berkeley Vincent as an Executive Vice President to lead Innovative Medicines division and as a member of my executive team as of April 8th. Let's look at the financials.
Net sales, a healthy growth of almost 18% compared to the previous year's quarter one. Also operating profit growth 47%, which brought us to operating profit margin of 27.5%. Earnings per share increased 47%. Looking at net sales in more detail, Innovative Medicines drove the net sales growth with royalties and tablet sales. As I already mentioned, all the divisions are performing well, of course, in relation to the size of the division. Branded Products growth was EUR 5.2 million, Generics EUR 1.9 million, and Animal Health EUR 1.1 million. Even Fermion external sales grew EUR 1.8 million, ending up to EUR 480 million of net sales during Q1. The operating profit consists, of course, the royalties here in the column three, close to EUR 41 million, and change in sales volume of EUR 21 million. We of course see some effect on decreasing prices, as we usually see.
The biggest product suffering of this are, of course, Simdax and Dexdor, but there are other generics as well. This comprises of EUR 9.3 million. That also includes effects and changes in cost of goods. No major milestones received in Q1. We also see increase in our fixed cost. Our operating profit was close to EUR 150 million during Q1. Now to Innovative Medicines. The division growth was close to 54%, and here we can see the Nubeqa royalties and tablet sales of close to EUR 145 million. Some other business of EUR 5.4 million, which is usually sales of services to our partners, resulting EUR 150 million of net sales. As we remember from the previous years, we start with the lower royalty rate from there in the beginning of the year. The royalties are tiered during the financial year.
We see in Q1 clearly a lower income of Nubeqa compared to the last quarter of previous year, but clearly a higher Nubeqa revenue compared to the previous year's quarter one. Royalties were EUR 95 million and tablet sales to Bayer, EUR 50 million. Branded Products close to 7% growth compared to previous year with EUR 82.2 million. Easyhaler continues to drive growth in this division, especially budesonide-formoterol, as the recent changes in treatment guidelines from last year favor the use of combination products over the mono products, and we've been able to really increase our sales according to this new guideline. The good growth momentum in women's health therapy area continues with the HRT products. Generics and Consumer Health, 1.4% growth.
It's according to market growth, maybe slightly below that, but this is only one quarter, and we all know that this is really a very wide portfolio in many different geographies. This is a very good achievement for the first quarter. Animal Health, 3.3% growth. Of course, again, a very wide portfolio both for companion animals and livestock, and a global portfolio, and the growth comes from all of the different geographies in both segments or both units. When we look at the top 10 products, of course we see the Nubeqa, as we discussed, driving the growth, Easyhaler, 7% growth. Entacapone slightly minus compared to the previous year's quarter one, but this is mainly again a timing issue of deliveries to different regions and different partners.
Same goes with the Dexdomitor and the Animal Health DDA portfolio, number 4 here, which grows almost 11%, and that is again a result of deliveries leaving during Q1. As I mentioned, women's health continues good growth trajectory with almost 15% growth. Burana slightly decreasing almost 6%. That's also more of a timing issue and depends on the season. We see three of our generics, Trexan, quetiapine, and Fareston, which have a very healthy growth. This is partly due to the previously mentioned timing of deliveries to our partners, but also showing that, for example, Trexan is a gold standard treatment globally used both in cancer and autoimmune diseases and holds a solid position in our top 10 products. Simdax, as I already mentioned, facing a heavy generic competition in Europe.
Now, Innovative Medicines during the quarter one comprised 36% of our net sales, and Generics 32%, and Branded Products 20%. Animal Health and Fermion together were 12% of our net sales. Our clinical development pipeline list is now a bit longer with the new combination study for ODM-212, but I'll go through the list to remind us what we have now going on. The two first ones are studies on Nubeqa, the DASL-HiCaP for the neoadjuvant use of darolutamide in prostate cancer, ARASTEP for the biochemical recurrence of prostate cancer. OMAHA 3 and 4 are studies for metastatic castration-resistant prostate cancer with opevesostat molecule that Orion has developed and then out-licensed to MSD. Then a bit of an odd product on this list, which is otherwise oncology products or molecules, is levosimendan.
It's an old classic from Orion's portfolio, the same molecule as we have in Simdax, and that's developed for pulmonary hypertension. There are two phase III studies ongoing with that by our partner Tenax. Two phase II studies, again with opevesostat for women's cancers like breast, endometrial, and ovarian cancer by MSD. This is, of course, to test whether this mechanism of action would also work for hormonal cancers in women. SUPIDAS is still ongoing. That was the phase II study that was used when the phase III studies with opevesostat started. The results of that study were used for planning of those phase IIIs. TIDAS is a monotherapy study, a phase II study for ODM-212 for malignant pleural mesothelioma, and also for epithelioid hemangioendothelioma.
These are two very rare cancers, solid tumors, and we think that this molecule, based on its mechanism of action, should have a direct anti-tumor activity to these cancer types. The newest addition, TEADCO, CO referring to combinations. The indications here, the cancers are mesothelioma, non-small cell lung cancer, and pancreatic cancer. Here we are combining ODM-212 with some known drugs that are used for these specific cancers, and we use the other kind of mechanism of the inhibition, which would fight for the drug resistance or prevent the drug resistance that patients usually show to these currently used treatments. Sustainability as another topic. Some key figures of Orion sustainability programs. We've been able to decrease our greenhouse gas emissions by 13%, and this is Scope 1 and 2, so doesn't include the Scope 3. Our injury rate is 4.9, and there is clearly room to improve there.
For this year, we have very ambitious targets for LTIF. Two things regarding more of a code of conduct or how we operate within own company and with our suppliers. This has to do with the code of conduct. In Orion, 98% of our employees have carried out or done the training for code of conduct. Also, we do this code of conduct training and agreement with our suppliers, and 96% of our suppliers also adhere to code of conduct, our third-party code of conduct practices. We have specified our outlook for this year. We gave our outlook in January, and now after Q1, when a fourth of the year has already passed, we are a bit more wiser, and we are able to increase the lower limit of our range by EUR 50 million, both on net sales and operating profit.
The net sales range was EUR 1.9 billion-EUR 2.1 billion in the original outlook, and now it's from EUR 1.95 billion- EUR 2.1 billion. Same with the operating profit, which was previously EUR 550 million-EUR 750 million, and now it's from EUR 600 million- EUR 750 million. Here are some upcoming events for this year. I think at this point, I thank you for your attention, and I think it's time for questions.
Yes. Thank you, Liisa, for the presentation and setup for today. Now let's turn to the questions. We will first start with questions on the conference call line. At this point, I would like to hand over to the operator.
If you wish to ask a question, please dial pound key five on your telephone keypad. To enter the queue, if you wish to withdraw the question, please dial pound key six on your telephone keypad. The next question comes from Alex Moore from Bank of America. Please go ahead.
Hi there. Thanks for taking my questions. Two for me, both on Nubeqa. You've previously mentioned that quarterly royalty reporting can be impacted by last month estimates and some reconciliation effects. I was just wondering for Q1, was there any particular conservatism or phasing assumptions baked into your sales estimate for March? Then separately, can you give me high level color on whether the reconciliation for sales in December was meaningfully positive or negative in terms of impact on your reported royalty for the quarter? Secondly, based on your current assumptions for full year sales run rate and tiered royalty rate, do you see consensus expectations of around 50% growth for Nubeqa sales this year as achievable? Thank you.
Maybe you go, René.
Yeah, maybe I can take that one as well. I'll start first with basically December numbers. We always try, if possible, to close the year with the actual reports, and that we managed to do last year, so there was no reconciliation or overflow from 2025 to 2026. Naturally, as we said, the last month of the quarters within the year are based on estimates that we then have and the latest data we have, and then we'll be updating in the second quarter, and then we will discuss that, of course, in Q2, but we are not giving details in between months of how the Nubeqa accruals and actuals go. Yes, we are very happy, of course, that Bayer is also optimistic on the full year of Nubeqa, and so are we.
Of course, we do our own scenarios and try to make a balanced outlook for the year that includes various scenarios. Other than that, not commenting on Bayer's estimates.
The next question comes from Sami Sarkamies from Danske Bank Markets. Please go ahead.
Hi. I have two questions. Starting from the guidance upgrade, I think you mentioned that you were just wiser after Q1. Can you specify, was the upgrade just based on Q1 performance, or have you also upgraded assumptions related to the rest of the year?
Yeah, maybe I can comment to that. As Liisa said, of course, we have one quarter behind us, and that was solid across the businesses and also, I think Nubeqa performing very nicely in the numbers and in the market. I think if we look at really the lower boundary, we also see that the probability for that old outlook lower limit starts to be quite low and made sense to raise that lower limit to a bit higher. When it comes to other aspects, some also affect from the fact that we have a little bit more information on USA tariffs for pharma for this year, that the impact would be earliest for October quarter.
As that information came through, that also reduces a little bit of the downside risk, although being said, it is still something of which is uncertain as it's still not in place and will be tested at the end of the year what the impact will be, if any, at that point of time.
Okay. My second question would be related to Nubeqa product deliveries. These grew only 30% in Q1. I think they were also a bit small in Q4. Should we just assume that inventories at Bayer have become lower in the last couple of quarters and these product deliveries will pick up at some point in time during the rest of the year?
Well, I think the tablet deliveries from Orion to Bayer is, I would say, not a very good lead indicator for how Nubeqa sales would develop or how the inventories. The supply chain is really long, if you think the global supply chain. I would advise not to look at that tablet number or tablet sales. We ship according to Bayer's forecasts. Of course, here for the shipments, there is the same factor than for any other shipments, that sometimes they leave on a certain last day of a certain month or then first day of the next month. There might also be big differences depending on when the shipments leave Orion. That's not a very good and reliable indicator for prognosing inventories or future sales.
Perhaps I can continue here a little bit.
Yes, please.
That we do expect for the full year that we will have higher tablet deliveries than what we had in Q1.
Definitely.
It wasn't yet, I think, representative of the average level for the year.
No. This is exactly what I mean, and yeah.
Okay, actually, I have one more question regarding the new combination study for ODM-212. Can you tell a bit more about the study? How many patients were recruited? When are you expecting readouts? It would be interesting to hear what is currently the market for the drugs that you will be combining ODM-212 with?
Well, I think I'll start with the studies. These are not huge studies. I don't have the exact number of patients unless my colleagues here have that. Let's remember that both of these indications, even though they are big ones, so we are now carrying out phase I-B/II, so we are even first trying different dosing with some of the combined drugs. For the results and readouts, I would be on the safe side to say that we can expect those during 2028. The markets for the drugs that we are combining, I'm not going to share here the market details of those drugs, but those are listed, the ones that we combined with are listed in the press release currently.
Okay.
Take into account the indications.
Yeah. Okay. Assuming sort of positive readout in 2028, you probably still need to do additional studies for these patients?
Yes.
Yeah. Maybe on the market potential, think about, the drugs that you are combining with are these blockbuster products?
Oh, yes. Indeed, some of them are.
They are.
Yes.
One needs to remember that their indication may be wider than the one we are targeting with this combination. We have listed the active ingredients in the press release we announced earlier this morning. With that, you can definitely find out the brand names for these products. Again, please bear in mind that their indication may be wider than the one we are targeting with these trials.
Okay. Thank you. I don't have any further questions.
The next question comes from Matti Kaurola from OP Corporate Bank. Please go ahead.
Hey, thank you for getting the question. First on the Nubeqa royalty rate. What we should think about it during this Q1, is it comparable with what we saw last year first quarter, or is it higher as now the sales has, of course, grew from the Q1 last year?
Apologies, Matti, the line was a bit bad right now. There's somewhat echo. Could you please repeat your question?
All right. Hopefully, it's better now. I was asking about the royalty rate during the Q1, so is it at the same level than last year, or is it higher now as the Nubeqa sale has grown from last year?
I don't think we comment on the royalty rates in that perspective as to where the tier break points are. You'll have to probably wait for that calculation to be done a bit later during the year.
As a base assumption.
All right.
Each and every year when we are growing faster compared to previous year, we will be reaching the higher tiers earlier than last year. In that sense, in Q1 also, probably the average is somewhat higher than last year.
All right. Maybe then another question regarding the sales and marketing costs as they've been increasing. Could you roughly say how much there is the actual costs and how much are the Endo royalties? These are causing the cost growth.
Yeah, of course, Endo royalties are playing a role in their part, but also we have added sales force also to support especially Branded Products in some European countries. You will see both effects there visible. Of course, with Nubeqa growing quite a lot from last year's Q1, then, of course, those would be also visible in the sales and marketing.
Okay. One more question regarding the R&D pipeline. As you said that there is this one kind of the odd study which is not covering oncology. I think it was last year exactly when you were putting this Tenax study in your pipeline, and could you remind us what was the reason to add that study back then to your pipeline? Why it was not there prior to a year ago? You want to be sold.
Yeah, that's a very good question, and thank you for asking so that we can remind. I think that was the time when Tenax started the phase III program for pulmonary hypertension. They had been working with levosimendan for a while, doing some confirmatory studies, but that was exactly the time when they were able to start the first study, and then eventually later on last year, they started the next study or the second study for pulmonary hypertension. There is no other reason for that.
Okay, no further questions.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Anssi Raussi from SEB. Please go ahead.
Hi, Olli. Yes, it comes from SEB. One question from me regarding Nubeqa. When we think about this early stage indication for Nubeqa, what would be reasonable timeline to expect that you would jump in, which would, of course, trigger this expense for you? Because I have understood that Bayer is fully responsible for the development for now.
Indeed. This relates to the DASL-HiCaP study, and the readout for this study, if I remember correctly, is 2028.
Estimated in 2028. Early 2028.
Yeah, estimated in 2028, and I think that the latest point for us to jump in and use our opt-in would be when we see the results of the study.
Okay. That's clear. Thank you. Nothing else from me.
The next question comes from Iiris Theman from DNB Carnegie. Please go ahead.
Hi. I have just one question. What pipeline news do you expect in the next 12 to 18 months? Thanks.
Well, I'll start with our ambition to start phase I study, at least one phase I study with our biologics during this year, by the end of 2026. Then if you ask for the next 12 months, of course, then we move to 2027, and there I hope to see another biologic entering clinical stage. I think those are the major initiations of new projects. Then regarding the results, no major results that we would be expecting this year.
With the exception of the level,
Oh, yeah.
level trial, phase III
Yes.
... trial by Tenax in Q3 this year.
This year.
Yeah.
Thank you, Tuukka. In 2027, the,
ARASTEP.
ARASTEP, there will be a readout for ARASTEP in 2027. Again, what else did we have in 2027?
Current estimate for the women's trials with opevesostat.
That's right. Yeah.
Current estimate is in the end of 2027. We'll see how that pans out.
Mm-hmm.
Also for our first ODM-212 phase II, so with the mono trial, current estimate is also in the end of 2027, but it may move either direction depending on recruitment rates and so forth.
Okay, anything about opevesostat ODM-208 for prostate cancer?
The readout for both of the studies is 2028.
Yeah. The estimated,
Mm-hmm.
Final readout is in summer 2028 for both of these trials.
Okay. Thank you.
There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Thank you, operator. We'll turn to the webcast questions. Again, you still have the opportunity to type in your questions by using the webcast chat if you wish. We have here one question coming from Shan Hama from Jefferies. Shan is interested to hear that could we please provide an update on opevesostat timing, and if we could still see interim data this year following Merck's comments in 2025 ASCO, so last year.
Mm-hmm. Well, I think I can only repeat what we said a minute ago, that the readouts for both of the studies are estimated to happen in 2028. Regarding any interim results or interim analysis, I don't have information on that. That should be asked from MSD.
Exactly. Thank you, Liisa. We have no further questions either from the webcast, and I think that we don't either have any follow-ups on the conference call line. I think it's time to wrap up on some closing words if we wish, Liisa.
Yes. I thank you for your attention and very good questions. Of course, I hope that you will be attending our upcoming events this year, and have a nice rest of the day. Thank you.