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 the 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 solid, in a solid way and very well, I would say so.

We also have good news regarding our clinical pipeline. ODM-212 has been granted orphan drug designation in mesothelioma by FDA, now in April.

We've also started a new Phase 1b/2 study called TEET-CO, which is a basket trial evaluating ODM-212 in combination with standard-of-care treatments in patients with selected advanced solid tumors, and I will talk more about that later on. Also, we have strengthened our executive team.

We've appointed Mr. Barclay 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, but as I already mentioned, all the divisions are performing well, of course, in relation to the size of the division. Branded Products growth was €5.2 million, Generics €1.9 million, and Animal Health €1.1 million, and even Fermion external sales grew €1.8 million, ending up to €418 million of net sales during Q1.

The operating profit consists, of course, the royalties, here in the column three, close to €41 million, and change in sales volume of €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 €9.3 million, that also includes FX and changes in cost of goods.

No major milestones received in Q1, and then we also see increase in our fixed costs. Thus our operating profit was close to €150 million during Q1.

Now to Innovative Medicines. The division growth was 40 close to 54%, and here we can see the Nubeqa royalties and tablet sales of 145 close to €145 million, some other business of €5.4 million, which is usually sales of services to our partners, resulting €150 million of net sales.

As we remember from the previous years, we start with the lower royalty rate from Bayer in the beginning of the year, the royalties are tiered during the financial year, and we see in Q1 clearly lower income of Nubeqa compared to the last quarter of previous year, but clearly a higher revenue, Nubeqa revenue, compared to the previous year's quarter one. Royalties were €95 million and tablet sales to Bayer €50 million.

Branded Products, close to 7% growth compared to previous year, with €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 & 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, look, 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 and 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 four 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. Then we see three of our generics: Trexan, quetiapine, and Fareston, which have a very, 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 golden 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 a 36% of our net sales, and Generics 32%, and Branded Products 20%. Animal Health and Fermion together were 11%, 12% of our net sales.

Our clinical development pipeline, the 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 biochemically reoccurring prostate cancer; OMAHA 3 and 4 are studies for metastatic castration-resistant prostate cancer with opevesostat, a 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, and there are two Phase 3 studies ongoing with that by our partner, Tenax.

Then two Phase 2 studies, again with opevesostat, for women's cancers, like breast, endometrial, and ovarian cancer, by MSD, and this is, of course, to test whether this mechanism of action would also work for hormonal cancers in women. CYPIDES is still ongoing, that was the Phase 2 study that was used when the Phase 3 studies with opevesostat started, the results of that study were used for planning of those Phase 3s.

TEDES is a monotherapy study, a Phase 2 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, TEET-CO, 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 a mechanism of TEAD 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's sustainability programs: we've been able to decrease our greenhouse gas emissions by 13%, and this is Scope 1 and 2, 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; and then two things regarding more of a kind of 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 are also adhered 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 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 €50 million both on net sales and operating profit. The net sales range was €1.9 to €2.1 billion in the original outlook, and now it's from €1.95 billion to €2.1 billion.

Same with the operating profit, which was previously €550 million to €750 million, and now it's from €600 million to €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 set up for today. Now let's turn on to the question.

We will first start with questions on the conference call line, at this point, I would like to hand over to the operator.

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, is there any particular conservatism or phasing assumptions baked into your sales estimate for March? Then separately, can you give any 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?

Then 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

I can take that one. 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, there was no reconciliation or overflow from '25 to '26. 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 that we have, and then we'll be updating in the second quarter, and then we will look, discuss that, of course, in Q2, but we're not giving details between the in between months of how then Nubeqa accruals and actuals go.

Then, yes, we are very happy, of course, that the 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.

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?

Maybe I can comment 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 a bit higher. When it comes to other aspects, some also effect from the fact that we have a little bit more information on the USA tariffs for pharma for this year, that the impact would be earliest for October quarter.

That, 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 then end of the year, what the impact will be if any at that point of time.

Okay. Then 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?

I think the tablet deliveries from Orion to Bayer is not a very good, I would say not a very good lead indicator for how Nubeqa sales would develop or how The supply chain is really, 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,

is

that we do expect for the full year that we will have higher tablet deliveries than what we had in Q1. It wasn't yet I think representative of the average level for the year.

No, no, this is exactly what and yep.

Okay. Then 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 will be recruited, when are you expecting readouts? Then it would be interesting to hear what is currently the market for the drugs that you will be combining ODM-212 with.

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, but let's remember that both or these indication, even though they are big ones, we are now carrying out Phase 1b/2, 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 '28.

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 combine with are listed in the press release currently.

Taking

into account the indications.

Yeah. Assuming sort of positive readout in '28, 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,

but then again,

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.

Hi. Thank you for taking my question.

First thing, Nubeqa royalty rate. What did you think about it during this Q1?

Is it comparable to 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 some 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, is it at the same level than last year or is it higher now as the Nubeqa sales has grew 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, 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 end-royalties? These are kind of causing the cost growth.

Of course, end-royalties are paying 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 sales and marketing.

Okay. Then 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 year ago, Q1 results?

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 3 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.

Hi all. Yes, it's Anssi 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 read out for this study, if I remember correctly, is '28.

Estimated in '28, early '28.

Estimated in '28, 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.

That's clear. Thank you.

Nothing else from me.

Hi. I have just one question.

What pipeline news do you expect in the next 12 to 18 months? Thanks.

I'll start with our ambition to start Phase 1 study, at least one Phase 1 study with our biologics during this year, by the end of '26. Then if you ask for the next 12 months, of course, then we move to '27, 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 3 trial by Tenax in Q3 this year.

This year.

Yeah.

Thank you, Tuukka. Then in '27, the ARASTEP.

There will be a readout for ARASTEP in '27. Then again, what else did we have in '27?

Current estimate for the women's trials with opevesostat, current estimate is in the end of '27, we'll see how that pans out. Also for our first ODM-212 Phase 2, with the monotrial, current estimate is also in the end of '27, but it may move either direction depending on recruitment rates and so forth.

Anything about opevesostat, ODM-208, for prostate cancer?

The readout for both of the studies is '28.

The estimated final readout is in summer '28 for both of these trials.

Thank you.

Thank you, operator. Then 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 hear one question coming from Sean Hama from Jefferies.

Sean 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 '25 ASCO, last year.

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 '28, and regarding any interim results or interim analysis, I don't have information on that, so 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 lines, I think it's time to wrap up and some closing words if you wish, Liisa.

Yes. I thank you for your attention and very good questions, and of course, I hope that you will be attending our upcoming events this year, and have a nice rest of the day.

Thank you.