Here are Antti’s pre-comments as Orion reports its Q1 results on Thursday, April 23rd.
We expect strong revenue and earnings growth from Orion, supported particularly by Nubeqa. We forecast 2026 to be a period of steady growth for Orion, supported by highly predictable drivers. In contrast, important binary research results are expected in 2027–28, which will significantly impact future potential.
And here are Antti’s comments on the company’s recent news
Orion announced on Monday that its cancer drug candidate ODM-212 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of mesothelioma. ODD status provides financial incentives and protects the drug’s commercial potential in the future. This positive news in itself has no impact on our view of the risk level or schedule of the ODM-212 development program.
Net sales were EUR 417.7 million (EUR 354.6 million in 1–3/2025)
Operating profit was EUR 114.8 (77.9) million
Basic earnings per share were EUR 0.64 (0.44)
Cash flow from operating activities per share was EUR 0.26 (0.55)
The outlook for 2026 has been refined: Net sales are estimated to be EUR 1,950–2,100 million. Operating profit is estimated to be EUR 600–750 million. Previously, net sales were estimated to be EUR 1,900–2,100 million and operating profit EUR 550–750 million.
Outlook for 2026 (refined on 23 April 2026)
Net sales are estimated to be EUR 1,950–2,100 million.
Operating profit is estimated to be EUR 600–750 million.
Previous outlook for 2026 (given on 14 January 2026)
Net sales are estimated to be EUR 1,900–2,100 million.
Operating profit is estimated to be EUR 550–750 million.
An article in Kauppalehti suggests that Orion’s stock drop today is due to a sharp increase in research and development expenses. On the contrary, a long-term investor should be pleased with significant R&D boosts, especially in the pharmaceutical industry. Overall, it’s a solid, decent result, but I still need to look into the details.
A fairly expected result, in my opinion. I see the reason for the share price drop mainly as an unwinding of overvaluation. If we assume a future return on equity (ROE) of about 35% and an EPS of around €2.80 with a growth rate in the 5% range going forward, we arrive at a fair value of approximately €60. I wouldn’t make any forecasts more bullish than this for the long term, as pharmaceutical companies’ earnings tend to depend heavily on future patent-protected drugs, and there is no certainty yet of a successor to Nubeqa of the same caliber.
Here’s a new company report from Siltanen after Q1.
Orion’s Q1 was again strong and in line with our expectations. Revenue grew by 18% and operating profit by 47%, supported by Nubeqa’s high-margin growth. Among other business areas, Branded Products developed particularly well with the growth of the Easyhaler product family. The company tightened its 2026 guidance by raising both the revenue and operating profit ranges from the bottom end, based on a strong start to the year. Forecast changes will this time be cosmetic as the company proceeds on the growth path we anticipated. We reiterate our Buy recommendation and target price of 80 euros.
Views on Orion’s share price can validly be presented within a fairly wide range. This €60 is fine, Inderes’s (Inden) €80 is fine, and the €100 presented by Erkki Sinkko in the media is also fine. This isn’t a bargain-bin stock, but cash is flowing in massively, all the company’s divisions are rocking, and there don’t seem to be any immediate major threats unless Trump completely messes things up with drug tariffs.
Unusually, I have refrained from giving Orion’s stock a “correct” price level — for now. This is because next year and the one after that, we will be at a turning point. The thesis launched by @Antti_Siltanen, that the looming end of a drug patent (in this case Nubeqa) starts to affect the share price about 5 years in advance, should gradually start to show in 2027-28. On the other hand, during these couple of years, we will get important interim data from Orion’s R&D pipeline — be it good or bad.
Against this background, all €60-100 estimates are reasonably possible with a two-year outlook. So, while waiting for this, we hold.
Orion Animal Health receives FDA approval for Tessie® (tasipimidine oral solution)
ORION CORPORATION
PRESS RELEASE
MAY 12, 2026, AT 10:30 AM
Orion Animal Health receives FDA approval for Tessie® (tasipimidine oral solution)
Orion Corporation received approval from the U.S. Food and Drug Administration (FDA) on May 6, 2026, for Tessie® (tasipimidine oral solution), intended for the treatment of noise aversion and separation anxiety in dogs.
Tasipimidine is a molecule patented by Orion and a new active ingredient for veterinary use in the United States. It acts on the central nervous system by inhibiting the startle reflex, thereby producing a calming effect.
“This approval complements Orion’s portfolio of veterinary medicines developed for clearly identified clinical needs,” says Niclas Lindstedt, Executive Vice President, Orion Animal Health. “We have a long tradition of innovation and aim to leverage our scientific expertise to create new treatment options for veterinarians and to support animal welfare.”
“Our upcoming presentation at the ASCO® meeting is an important milestone for the ODM-212 molecule, a pan-TEAD inhibitor in clinical development,” says Professor Outi Vaarala, Executive Vice President, Research & Development, Orion Pharma. “We look forward to sharing preliminary results from the TEADES study and discussing the ongoing development of the ODM-212 molecule in patients with solid tumors who have a high need for new treatments.”
Presenting results at ASCO does not guarantee brilliant results yet, but it does show that the findings are worthy of ASCO, which is a truly massive and significant event in oncology.
Orphan drug status has already been granted for pleural cancer. Additionally, it is being studied for rare sarcoma—diseases where the “hippo pathway” (hipporeitti) is active.
Let’s hope this molecule turns out to be a “hippo-sized” revelation. If Phase 2 is also successful, I expect the same licensing strategy will be pursued as with darolutamide, aka Nubeqa. There is competition on that pathway, which speaks to its significance, but it also adds business risk: if it works, who does it best, and who gets the biggest piece of the cake? They are starting with “rare cakes,” but there is potential for several cancer types where this signaling pathway is utilized by the cancer. The abstracts should become public today at midnight Finnish time.
As with other similar early-phase trials, transient renal adverse effects were observed, requiring downward dose adjustments, which may also decrease efficacy; irritation of the liver and pancreas was also noted. However, a maximum tolerated dose was not reached; Phase 2 continues, and an optimal dose will likely be found.
The testing involved 20–320 mg per day as a small molecule (i.e., in tablet form), which is an excellent thing. Novartis discontinued the development of its own equivalent drug due to adverse effects and lack of efficacy observed in Phase 1. Others are still continuing with results comparable to Orion’s, e.g., YAP/TEAD inhibitor VT3989 in solid tumors: a phase 1/2 trial | Nature Medicine
The efficacy of ODM-212 in patients with metastatic cancer previously treated with immunotherapy or chemotherapy is currently “promising” but not revolutionary; in mesothelioma (pleural cancer), the response rate was 27.8% for 18 patients, and the disease control rate was 77.8%. Once the optimal dose is identified, efficacy may increase in Phase 2. Phase 3 will ultimately decide the game, and Orion is currently utilizing “Bigger Pharma” partners for such stages with its other molecules.
Here are Antti’s comments on the first results of Orion’s ODM-212 candidate
Orion announced over the weekend preliminary results from the Phase I/II clinical trial of the cancer drug candidate ODM-212. Based on the results presented at the ASCO congress, the drug candidate has been well-tolerated by patients and has shown preliminary signs of efficacy in hard-to-treat cancers. The clinical program for the drug candidate started in late 2022, so it is still in a very early stage of development.
@Antti_Siltanen’s conclusion: “The potential commercialization of ODM-212 is still several years away, so the project represents long-term potential for Orion.”
We are therefore still a long way from the situation where this project translates into profits on Orion’s bottom line. If it ever does. Nevertheless, this published information is preliminarily promising considering the 2030s.
Could you, however, try to bracket what the economic significance of the project would be if successful? Meaning, a marketable drug with patent protection would be created sometime in the next decade. Of course, there are many uncertainties in the air and much has to be assumed, but even a rough estimate would help to grasp the big picture Thanks!
It took the competing TEAD inhibitor VT3989 ~5 years to get from the start of the clinical program to the beginning of Phase 3. On this timeline, Orion’s Phase 3 could be completed by ~2034 and launch, for example, in 2035. In theory, of course, an accelerated marketing authorization could be sought after Phase 2 in a very optimistic scenario.
The probability of success (PoS) could be around 15%. Some de-risking has occurred based on Phase 1 tolerability, but proof of efficacy is still practically missing, as is broader safety data, of course.
Regarding peak sales estimates, monotherapy for mesothelioma and EHE alone would likely be quite moderate, perhaps a few hundred million USD per year. If these indications allow for expansion into other Hippo-driven cancers, we might be talking about the 500-1000 MUSD range. In a more bullish scenario, as a combination therapy, it could reach larger patient populations and blockbuster status. Let’s pull a figure out of the hat, say 2,000 MUSD.
The present value of these types of cash flows revolves roughly around 1-5% of Orion’s market capitalization, so I haven’t made any particularly serious calculations because the weight is small. But by the end of Phase 2 at the latest, this candidate will start to carry weight on the scales—provided the results are good, that is.
Orion/Bayer’s Nubeqa vs. market leader Xtandi. Nubeqa took the win in patients’ cognitive performance—meaning memory, executive function, and quality of life in general—which is considered increasingly important alongside mere length of life.
Results like these gradually benefit Orion in the form of growing royalties. Xtandi has been the market leader, but Nubeqa’s safety has already been proven superior, with less blood-brain barrier penetration and fewer interactions with other drugs, so…. Generic versions of Xtandi are gradually entering the market, but how many will risk their well-being for the sake of money? Some, perhaps. And of course, not everyone experiences side effects or has an extensive arsenal of other medications in use, but a doctor will likely choose the safer option if given the choice.
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Thanks!