Live News • Jun 24
Orion Pharma Receives EU Orphan Drug Status for ODM-212 in Mesothelioma Treatment Orion Pharma, part of Orion Oyj, received Orphan Drug Designation from the European Commission for its investigational drug ODM-212 to treat malignant mesothelioma, following a recommendation from the EMA’s Committee for Orphan Medicinal Products.
ODM-212 is an oral small-molecule pan-TEAD inhibitor now in a Phase 2 trial in patients with malignant pleural mesothelioma and other solid tumors linked to Hippo pathway dysfunction. The designation brings regulatory support plus potential market exclusivity if the drug eventually gains approval.
Orion Oyj’s share price is around €68.90, with the stock up about 8.8% year to date.
The key takeaway is that Orion Oyj is progressing a specialist oncology candidate with EU orphan status, which can improve the economics of drug development but still carries clinical, regulatory and commercialization risks given that ODM-212 is only in Phase 2. Announcement • Jun 02
Orion Pharma Announces First Results From Phase 1/2 TEADES Trial With TEAD Inhibitor ODM-212 In Patients With Advanced Solid Tumours Orion Pharma announced first Phase 1 results from the ongoing Phase 1/2 multi-site, open-label, first-in-human TEADES trial evaluating the safety, tolerability and preliminary efficacy of ODM-212, a small molecule oral pan-TEAD inhibitor in patients with advanced solid tumours. According to the results, ODM-212 was well tolerated. Dose limiting toxicities (DLT) were not reported and the maximum tolerated dose (MTD) was not reached. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 7.9% of patients. Other common TRAE’s were increased lipase (15.8%) and nausea (10.5%). Treatment responses by RECIST 1.1 were observed across multiple doses (overall response rate1, ORR 15.6%), predominantly in patients with mesothelioma (ORR 27.8%, disease control rate2, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The new data were presented during the 2026 American Society of Clinical Oncology Annual Meeting, taking place in Chicago, IL, United States, from May 29-June 2, 2026. Phase 2 of the TEADES trial is ongoing. The trial will enroll up to 300 patients with malignant pleural mesothelioma (MPM), EHE or other solid tumours with dysfunction in Hippo pathway, and who have progressed despite available standard treatments and with limited further treatment options. Another ongoing Phase 1/2 trial TEADCO is evaluating ODM-212 in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction in Hippo pathway. The trial will include patients who have progressed despite available standard treatments and with limited further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at oncology centers in the US and Europe. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Live News • May 31
Orion Pharma Reports Early TEADES Trial Data for ODM-212 in Advanced Solid Tumours Orion Pharma reported first Phase 1/2 results from its TEADES trial of TEAD inhibitor ODM-212 in advanced solid tumours.
Data presented at the 2026 ASCO Annual Meeting showed ODM-212 was well tolerated, with proteinuria as the most common treatment-related adverse event.
Early signs of efficacy were observed in Hippo pathway dysregulated tumours such as mesothelioma and epithelioid hemangioendothelioma (EHE).
These early TEADES data indicate a potential pipeline opportunity in difficult-to-treat tumour types. At the same time, tolerability signals such as proteinuria will be important to monitor as dosing and treatment duration change in later stages of development.
Investors may want to track whether Orion advances ODM-212 into larger trials, as that would likely require higher R&D spending and could influence the company’s risk profile and the timing of any potential future revenues from this program. Announcement • May 13
Orion Corporation Receives Us Fda Approval for Tessie (Tasipimidine Oral Solution) for Treatment of Noise Aversion and Separation Anxiety in Dogs Orion Corporation announced that on 6 May 2026 the U.S. Food and Drug Administration (FDA) has approved Tessie (tasipimidine) oral solution for dogs. Tessie is indicated for the treatment of noise aversion and separation anxiety in dogs. Tasipimidine is an Orion proprietary molecule and a new active substance for veterinary use in the U.S. It acts in the central nervous system by blocking the startle reflex and thus counteracting arousal. Orion’s long-standing strategic partner, Zoetis, has the exclusive right to market and sell Tessie in the United States. Tessie is anticipated to be available in the U.S. by mid-2027 and will expand Zoetis' behavioral product portfolio, alongside Sileo and Bonqat. Announcement • Apr 29
Orion Corporation Announces Composition of Nomination Committee, Effective Date of the Appointments Is April 27, 2026 Orion Corporation announced that the Board of Directors has appointed Annika Ekman, Petteri Karttunen, Risto Karvonen, Veli-Matti Mattila, Hilpi Rautelin, and Seppo Salonen to the Nomination Committee of the company. Hilpi Rautelin was appointed as Chair of the Committee. The duty of the committee is to prepare and present a recommendation to the Board of Directors for a proposal to the Annual General Meeting of shareholders concerning the composition and compensation of the Board. The essentials of the charter of the Nomination Committee and a description of the appointment process of its members are provided at a page in the Corporate Governance section of the Orion Group website. The effective date of the appointments is April 27, 2026. Announcement • Apr 26
Orion Oyj Revises Earnings Guidance for the Full Year 2026 Orion Oyj revised earnings guidance for the full year 2026. For the year, Net sales are estimated to be EUR 1,950 million to EUR 2,100 million. Operating profit is estimated to be EUR 600 million to EUR 750 million as compared to previously announced Net sales are estimated to be EUR 1,900 million to EUR 2,100 million. Operating profit is estimated to be EUR 550 million to EUR 750 million. Due to the solid start of the year, the company have specified outlook for 2026 by narrowing both the net sales and operating profit ranges from the lower end. First Quarter laid a good foundation for the year. Announcement • Apr 25
Orion Corporation Initiates Teadco Phase 1b/2 Basket Trial Evaluating Odm-212 In Combination With Standard Of Care Treatments In Patients With Select Advanced Solid Tumours Orion Corporation (Orion Pharma) announced the initiation of a Phase 1b/2 basket trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADCO trial is a multi-centre, open-label basket trial designed to evaluate the efficacy, safety, dose and tolerability of ODM-212 in combination with standard of care in these indications. The first cohort of the TEADCO trial evaluates ODM-212 in combination with ipilimumab and nivolumab as a first-line treatment for patients with advanced malignant pleural mesothelioma. ODM-212 has the potential to both exert direct anti-tumour activity and prevent emergence of treatment resistance to standard of care therapies in this indication. The second cohort evaluates ODM-212 in combination with sotorasib, a targeted KRAS inhibitor, for the treatment of NSCLC in patients with KRAS G12C mutation. This arm has two sub-cohorts: patients who have been previously treated with KRAS G12C inhibitor and patients who have not received KRAS G12C inhibitor as a prior treatment. ODM-212 has the potential to prevent or overcome treatment resistance to approved KRAS inhibitors in this setting. The third cohort evaluates ODM-212 in combination with chemotherapy (nab-paclitaxel/gemcitabine) for the treatment of metastatic adenocarcinoma of the pancreas aiming to improve treatment efficacy through combination therapy. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Reported Earnings • Apr 24
First quarter 2026 earnings: EPS and revenues miss analyst expectations First quarter 2026 results: EPS: €0.64 (up from €0.44 in 1Q 2025). Revenue: €417.7m (up 18% from 1Q 2025). Net income: €90.4m (up 48% from 1Q 2025). Profit margin: 22% (up from 17% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 1.8%. Earnings per share (EPS) also missed analyst estimates by 13%. Revenue is forecast to grow 7.5% p.a. on average during the next 3 years, compared to a 4.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has only increased by 16% per year, which means it is significantly lagging earnings growth. Announcement • Apr 21
Orion Pharma’S Odm-212 Granted Orphan Drug Designation in Mesothelioma by the US FDA Orion Corporation announced that its investigational drug ODM-212 has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of mesothelioma, which is a rare and difficult to treat cancer. The FDA grants orphan drug designation to investigational therapies addressing rare diseases or conditions that affect fewer than 200,000 people in the US. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe. Orphan Drug Designation is granted by FDA to therapies intended to prevent, diagnose, or treat rare diseases or conditions. With this designation for ODM-212, Orion Pharma, the sponsor, is now qualified for incentives including tax credits, exepmption from user fees, and eligibility for a 7-year period of market exclusivity following approval. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Declared Dividend • Apr 04
Dividend of €0.90 announced Shareholders will receive a dividend of €0.90. Ex-date: 19th October 2026 Payment date: 27th October 2026 Dividend yield will be 2.5%, which is about the same as the industry average. Sustainability & Growth Dividend is covered by earnings (51% earnings payout ratio) but not covered by cash flows (116% cash payout ratio). The dividend has increased by an average of 3.3% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 27% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Announcement • Apr 01
Orion Corporation Appoints Berkeley Vincent as Executive Vice President, Innovative Medicines and A Member of the Orion Executive Team as of 8 April 2026 Orion Corporation (“Orion”) has appointed Berkeley Vincent as Executive Vice President, Innovative Medicines and a member of the Orion Executive Team as of 8 April 2026. The appointment is part of a leadership structure change in which the previously combined role of R&D and Innovative Medicines is split into two dedicated positions. This change reflects the continued growth and maturation of Orion’s Innovative Medicines pipeline and the increasing need to strengthen focus on global commercialization readiness. Outi Vaarala will continue in her role as Executive Vice President, R&D, and as a member of the Orion Executive Team. In his new role, Berkeley Vincent will be responsible for defining and implementing global commercialization strategies for Orion’s Innovative Medicines portfolio. His responsibilities include full P&L ownership, global launch sequencing, market access strategy, and the development of strategic partnerships, including licensing and acquisitions. He will work closely with R&D leadership to align development priorities with commercial and market needs. Berkeley Vincent brings more than 20 years of international pharmaceutical industry experience from senior global, regional and country leadership roles at Johnson & Johnson. Most recently, he served as President, Johnson & Johnson Innovative Medicines Canada, with full P&L responsibility. He has previously held roles including Managing Director of the Nordic cluster and Global Commercial Leader for IMBRUVICA. Berkeley Vincent: Born 1977, Irish and Swedish citizen. Education: MBA, DePaul University, Chicago, 2002, BSc (Management), Trinity College Dublin, 1999. Career: 2022– President, Johnson & Johnson Canada, 2019–2022 Nordics Managing Director, Johnson & Johnson, 2018–2019 Vice President, Customer Digital Strategy, Johnson & Johnson, EMEA, 2015–2018 Regional Strategy Leader, Johnson & Johnson, EMEA, 2012–2015 Global Commercial Leader IMBRUVICA, Johnson & Johnson, 2002–2012 Various commercial and leadership roles, Johnson & Johnson. Upcoming Dividend • Mar 18
Upcoming dividend of €0.90 per share Eligible shareholders must have bought the stock before 25 March 2026. Payment date: 02 April 2026. Payout ratio is a comfortable 51% but the company is paying out more than the cash it is generating. Trailing yield: 2.6%. Lower than top quartile of Finnish dividend payers (5.2%). In line with average of industry peers (2.7%). Declared Dividend • Feb 16
Final dividend of €0.90 announced Shareholders will receive a dividend of €0.90. Ex-date: 25th March 2026 Payment date: 2nd April 2026 Dividend yield will be 2.5%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is covered by earnings (51% earnings payout ratio) but not covered by cash flows (116% cash payout ratio). The dividend has increased by an average of 3.3% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 29% over the next 3 years, which should provide support to the dividend and adequate earnings cover. New Risk • Feb 13
New major risk - Earnings quality The company has a high level of non-cash earnings. Accrual ratio: 22% This is considered a major risk. Non-cash earnings can arise from many different things. However, if a company consistently has a high level of non-cash earnings, it may be a sign that they are recognizing revenue from customers before the full value of the sales are received as cash or they are not depreciating the value of their assets appropriately. These are practices that inflate earnings, while not providing a similar increase to cash flows. Companies in some select industries naturally have a high level of non-cash earnings and it is not a major concern. However, in the worst case scenario it can be an early sign of performance manipulation by management. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (22% accrual ratio). Minor Risk Dividend is not well covered by cash flows (116% cash payout ratio). Reported Earnings • Feb 13
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: EPS: €3.56 (up from €2.35 in FY 2024). Revenue: €1.89b (up 23% from FY 2024). Net income: €500.3m (up 52% from FY 2024). Profit margin: 27% (up from 21% in FY 2024). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 2.3%. Revenue is forecast to grow 6.9% p.a. on average during the next 3 years, compared to a 4.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 14% per year and the company’s share price has also increased by 14% per year. New Risk • Jan 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Finnish stocks, typically moving 5.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Dividend is not well covered by cash flows (105% cash payout ratio). Share price has been volatile over the past 3 months (5.5% average weekly change). Announcement • Jan 14
Orion Oyj Provides Earnings Guidance for the Full Year 2026 Orion Oyj provides earnings guidance for the full year 2026. For the year, Net sales are estimated to be EUR 1,900 million to EUR 2,100 million. Operating profit is estimated to be EUR 550 million to EUR 750 million. Announcement • Jan 08
Orion Pharma Announces Initiation of Really Irrelevant Phase 2 Trial of ODM-212 in Malignant Pleural Mesothelioma and Epithelioid Hemangioendothelioma (EHE) Orion Corporation announced initiation of a Phase 2 trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, as a monotherapy in malignant pleural mesothelioma (MPM) and epithelioid hemangioendothelioma (EHE), which are rare and difficult to treat cancers. The Phase 2 study is designed to further evaluate the efficacy, safety, dose and tolerability of ODM-212 in a patient population with significant unmet need where current treatment options are limited and outcomes remain poor. The first patient in the study was treated in December 2025. The TEADES trial is a Phase 2 multi-center, open-label study that will enroll approximately 300 patients with MPM, EHE or other solid tumors with dysfunction in Hippo pathway. The trial will include patients who have progressed after receiving standard treatments and have no further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway--particularly through YAP/TAZ activation--can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Malignant Pleural Mesothelioma (M PM) is a rare and aggressive cancer that originates in the pleura--the thin membrane lining the lungs and chest wall. It accounts for about 80-90% of all mesothelioma cases and is strongly linked to asbestos exposure. Current treatments mainly include chemotherapy and immunotherapy. Epithelioid Hemangioendotheliomas (EHE) is an ultra-rare vascular tumor or abnormality that arises from the cells lining the blood vessels. It is estimated that less than one per million people are living with this rare cancer. Currently there is no standard treatment for EHE. Announcement • Dec 04
Orion Oyj Updates Earnings Guidance for the Full Year 2025 Orion Oyj updated earnings guidance for the full year 2025. For the year, the company now expects Net sales are estimated to be EUR 1,820 million to EUR 1,900 million and Operating profit is estimated to be EUR 590 million to EUR 670 million against previous guidance of Net sales are estimated to be EUR 1,640 million to EUR 1,720 million and Operating profit is estimated to be EUR 410 million to EUR 490 million. Reported Earnings • Oct 29
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: EPS: €0.68 (down from €1.14 in 3Q 2024). Revenue: €423.2m (down 10% from 3Q 2024). Net income: €96.0m (down 40% from 3Q 2024). Profit margin: 23% (down from 34% in 3Q 2024). The decrease in margin was primarily driven by lower revenue. Revenue missed analyst estimates by 2.4%. Earnings per share (EPS) also missed analyst estimates by 1.9%. Revenue is forecast to grow 9.7% p.a. on average during the next 3 years, compared to a 5.2% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 10% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Oct 28
Orion Oyj Provides Earnings Outlook for 2025 Orion Oyj provided earnings outlook for 2025. For the period, the expects net sales to be EUR 1,640 million to EUR 1,720 million against EUR 1,630 million to EUR 1,730 million previously forecasted and Operating profit is estimated to be EUR 410 million to EUR 490 million against EUR 400 million to EUR 500 million previously forecasted. Upcoming Dividend • Oct 08
Upcoming dividend of €0.82 per share Eligible shareholders must have bought the stock before 15 October 2025. Payment date: 23 October 2025. Payout ratio is a comfortable 61% but the company is paying out more than the cash it is generating. Trailing yield: 2.3%. Lower than top quartile of Finnish dividend payers (6.0%). Lower than average of industry peers (2.7%). New Risk • Oct 07
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: €258k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. This is currently the only risk that has been identified for the company. Announcement • Oct 02
Orion Corporation Announces Phase 2 Study of ODM-105 in Insights Do Not Meet Primary Goal Orion Corporation announced that its candidate ODM-105 (tasipimidine) did not meet the primary goal in the clinical Phase 2 UNITAS study for the treatment of patients with insomnia. According to the study results, ODM-105 did not significantly improve insomnia-related symptoms such as time to fall asleep or sleep duration compared with placebo. ODM-105 was generally safe and well tolerated. Detailed results, including safety data, and their assessment are to be finalized. Price Target Changed • Aug 20
Price target increased by 7.5% to €68.70 Up from €63.90, the current price target is an average from 5 analysts. New target price is approximately in line with last closing price of €69.60. Stock is up 50% over the past year. The company is forecast to post earnings per share of €3.02 for next year compared to €2.35 last year. Reported Earnings • Jul 20
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: EPS: €0.59 (up from €0.37 in 2Q 2024). Revenue: €416.5m (up 27% from 2Q 2024). Net income: €82.5m (up 59% from 2Q 2024). Profit margin: 20% (up from 16% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) also surpassed analyst estimates by 14%. Revenue is forecast to grow 9.2% p.a. on average during the next 3 years, compared to a 5.6% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has increased by 15% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Jul 18
Orion Oyj, Annual General Meeting, Mar 24, 2026 Orion Oyj, Annual General Meeting, Mar 24, 2026. Price Target Changed • Jul 18
Price target increased by 7.1% to €60.50 Up from €56.50, the current price target is an average from 5 analysts. New target price is 13% below last closing price of €69.45. Stock is up 76% over the past year. The company is forecast to post earnings per share of €2.64 for next year compared to €2.35 last year. Announcement • Jul 10
Orion Oyj Upgrades Earnings Guidance for Full-Year 2025 Orion Oyj upgraded earnings guidance for full-year 2025. For the period, the company expects net sales are estimated to be EUR 1,630 million to EUR 1,730 million against Net sales to be EUR 1,550 million to EUR 1,650 million in previous full-year outlook and Operating profit is estimated to be EUR 400 million to EUR 500 million against Operating profit to be EUR 350 million to EUR 450 million in previous full-year outlook. Announcement • Jun 20
Orion Corporation Recommends Third Indication for Darolutamide for Patients with Advanced Prostate Cancer Orion Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for marketing authorisation in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The CHMP recommendation is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P1 In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040. Announcement • Jun 05
U.S. FDA Approves Third Indication of Darolutamide for Patients with Advanced Prostate Cancer Orion Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mHSPC), which is also known as metastatic hormone-sensitive prostate cancer (m HSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001) in patients with mHSPC. With this approval, darolutamide plusADT is indicated in the U.S. for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040. Darolutamide, under the brand name Nubeqa®?, is already approved in combination with ADT and docetaxel in over 85 markets around the world. It's also approved in combination with ADT for the treatment of patients with non-metastastatic castration-resistant breast cancer (nmCRPC). An approval process in the EU for the treatment of mHSPC in combination with ADT (without docetaxel) is already underway by Bayer. Nubeqa achieved blockbuster status in September 2024, with annual sales reported by Bayer reaching EUR 1.52 billion for the full year of 2024. Darolutamide is developed jointly by Orion and Bayer. About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus adT in patients with mHSP C. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Major Estimate Revision • Apr 30
Consensus EPS estimates increase by 12% The consensus outlook for fiscal year 2025 has been updated. 2025 EPS estimate increased from €2.29 to €2.57. Revenue forecast steady at €1.66b. Net income forecast to grow 15% next year vs 19% growth forecast for Pharmaceuticals industry in Finland. Consensus price target of €54.60 unchanged from last update. Share price rose 10.0% to €55.15 over the past week. Reported Earnings • Apr 23
First quarter 2025 earnings: EPS and revenues exceed analyst expectations First quarter 2025 results: EPS: €0.44 (up from €0.31 in 1Q 2024). Revenue: €354.6m (up 15% from 1Q 2024). Net income: €61.3m (up 40% from 1Q 2024). Profit margin: 17% (up from 14% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 3.7%. Earnings per share (EPS) also surpassed analyst estimates by 11%. Revenue is forecast to grow 7.5% p.a. on average during the next 3 years, compared to a 5.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 7% per year whereas the company’s share price has increased by 8% per year. Declared Dividend • Apr 15
Dividend of €0.82 announced Shareholders will receive a dividend of €0.82. Ex-date: 15th October 2025 Payment date: 23rd October 2025 Dividend yield will be 3.3%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is covered by earnings (70% earnings payout ratio) but not covered by cash flows (112% cash payout ratio). The dividend has increased by an average of 2.4% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 37% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Valuation Update With 7 Day Price Move • Apr 09
Investor sentiment deteriorates as stock falls 16% After last week's 16% share price decline to €46.86, the stock trades at a forward P/E ratio of 20x. Average forward P/E is 15x in the Pharmaceuticals industry in Europe. Total returns to shareholders of 22% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €72.58 per share. Announcement • Apr 04
Orion Corporation Approves Dividend for the Financial Year Ended 31 December 2024, Payable on 14 April 2025 and 23 October 2025, Respectively Orion Corporation at its AGM held on April 3, 2025, resolved, in accordance with the proposal by the Board of Directors, that a dividend of EUR 1.64 per share will be paid on the basis of the Balance Sheet confirmed for the financial year that ended on 31 December 2024. The dividend is paid in two instalments. The record date for the first instalment of EUR 0.82 per share is 7 April 2025 and the payment date is 14 April 2025. The record date for the second instalment of EUR 0.82 per share is 16 October 2025 and the payment date is 23 October 2025. In addition, the AGM authorised the Board of Directors to resolve, if necessary, on a new record date for payment and payment date for the second instalment of the dividend in case of changes in the rules of Euroclear Finland Oy or the regulations regarding the Finnish book-entry system or if other rules binding the Company so require. Announcement • Apr 03
Orion Corporation Announces Composition of R&D Committee Orion Corporation at its organising meeting, the Board of Directors of the company, which was elected by the Annual General Meeting of the Shareholders announced the compositions of the Board committees. R&D Committee: Hilpi Rautelin, Chairman, Kari Jussi Aho, Eija Ronkainen and Karen Lykke Sørensen. Personnel and Remuneration Committee: Veli-Matti Mattila, Chairman, Kari Jussi Aho, Maziar Mike Doustdar and Hilpi Rautelin. Audit Committee: Ari Lehtoranta, Chairman, Eija Ronkainen, Henrik Stenqvist and Karen Lykke Sørensen. Board Change • Apr 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 4 highly experienced directors. Director Henrik Stenqvist was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Upcoming Dividend • Mar 28
Upcoming dividend of €0.82 per share Eligible shareholders must have bought the stock before 04 April 2025. Payment date: 14 April 2025. Payout ratio is a comfortable 70% but the company is paying out more than the cash it is generating. Trailing yield: 3.0%. Lower than top quartile of Finnish dividend payers (5.9%). In line with average of industry peers (2.8%). Announcement • Feb 27
Orion Oyj Proposes Dividend for the Financial Year Ended 31 December 2024, Payable on 14 April 2025 and 23 October 2025 Orion Oyj at the the Annual General Meeting to be held on 3 April 2025, the Board of Directors proposed that a dividend of EUR 1.64 per share be paid on the basis of the Balance Sheet confirmed for the financial year that ended on 31 December 2024. No dividend shall be paid on treasury shares held by the Company on the record date for dividend payment. According to the proposal, the dividend would be paid in two instalments. The first instalment of EUR 0.82 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 7 April 2025, registered in the Company’s shareholders’ register maintained by Euroclear Finland Oy. The Board of Directors proposes that the first instalment would be paid on 14 April 2025. The second instalment of EUR 0.82 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 16 October 2025, registered in the Company’s shareholders’ register maintained by Euroclear Finland Oy. The Board of Directors proposes that the second instalment would be paid on 23 October 2025. Price Target Changed • Feb 26
Price target increased by 7.3% to €56.00 Up from €52.20, the current price target is an average from 5 analysts. New target price is approximately in line with last closing price of €54.60. Stock is up 48% over the past year. The company is forecast to post earnings per share of €2.29 for next year compared to €2.35 last year. Reported Earnings • Feb 26
Full year 2024 earnings: EPS exceeds analyst expectations Full year 2024 results: EPS: €2.35 (up from €1.55 in FY 2023). Revenue: €1.54b (up 30% from FY 2023). Net income: €329.9m (up 52% from FY 2023). Profit margin: 21% (up from 18% in FY 2023). The increase in margin was driven by higher revenue. Products in clinical trials Phase I: 1 Phase II: 2 Phase III: 3 Post-clinical trial products Pre-registration: 1 Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 3.4%. Revenue is forecast to grow 8.9% p.a. on average during the next 3 years, compared to a 6.4% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 7% per year whereas the company’s share price has increased by 10% per year. Announcement • Feb 26
Orion Oyj Provides Earnings Guidance for the Year 2025 Orion Oyj provided earnings guidance for the year 2025. For the year, net sales are estimated to be EUR 1,550 million to EUR 1,650 million and Operating profit is estimated to be EUR 350 million to EUR 450 million. Announcement • Dec 20
Orion Corporation Announces Change in Group Executive Management Board Orion Corporation announced that Olli Huotari, Senior Vice President responsible for Corporate Functions organization of the Orion Group and Secretary to the Board of Directors of Orion Corporation, and a member of the Executive Management Board of the Orion Group informed earlier of his decision to leave Orion on 31 May 2025. Mikko Kemppainen has been appointed as General Counsel and Secretary to the Board of Directors of Orion Corporation, and a member of the Executive Management Board of the Orion Group as of 1 June 2025. The appointed General Counsel Mikko Kemppainen will be responsible for the following of Olli Huotari’s responsibility areas: Compliance, Intellectual Property Rights, Legal Affairs, and Public Affairs. Other responsibility areas of Huotari will be transferred to other members of the Executive Management Board of the Orion Group as of June 1, 2025. Mikko Kemppainen holds a Master of Laws (Trained at the Bench) degree. He joined Orion as a Legal Counsel in 2006 and has been the Head of Legal Affairs at Orion Corporation since 2007. Prior to joining Orion, Kemppainen worked as Associate and Senior Associate at Hannes Snellman Attorneys Ltd. during 2000-2006. Reported Earnings • Oct 29
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: EPS: €1.14 (up from €0.44 in 3Q 2023). Revenue: €471.3m (up 56% from 3Q 2023). Net income: €160.8m (up 162% from 3Q 2023). Profit margin: 34% (up from 20% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 2.3%. Earnings per share (EPS) also surpassed analyst estimates by 8.2%. Revenue is forecast to grow 8.9% p.a. on average during the next 3 years, compared to a 7.4% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 7% per year whereas the company’s share price has increased by 6% per year. Announcement • Oct 25
Orion Corporation Decides to Terminate the ODM-111 Development Program Orion Corporation has decided to terminate the ODM-111 development program based on the risk-benefit analysis on the results of a longer non-clinical toxicology study. Recent findings indicate that the profile of the ODM-111 molecule does not support long-term use of ODM-111 and progression to later-stage development. Additionally, it is important to note that both prior non-clinical studies and the clinical Phase I trial with shorter durations of exposure to ODM-111 did not reveal any significant safety concerns. Exceptionally, Orion publishes information about a project in early clinical development stage in a stock exchange release, because in this case, the information is estimated to meet the definition of inside information due to ODM-111’s strategic importance. This does not affect Orion's current disclosure policy, according to which Orion publishes information on its R&D projects mainly in its interim reports and/or press releases, but, as a main rule, provides information on the results of clinical Phase III trials in separate stock exchange releases. Price Target Changed • Oct 22
Price target increased by 7.1% to €47.50 Up from €44.33, the current price target is an average from 6 analysts. New target price is approximately in line with last closing price of €47.51. Stock is up 29% over the past year. The company is forecast to post earnings per share of €2.19 for next year compared to €1.54 last year. Buy Or Sell Opportunity • Oct 18
Now 20% undervalued Over the last 90 days, the stock has risen 21% to €47.63. The fair value is estimated to be €59.66, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 7.3% over the last 3 years. Earnings per share has grown by 5.7%. For the next 3 years, revenue is forecast to grow by 10% per annum. Earnings are also forecast to grow by 13% per annum over the same time period. Upcoming Dividend • Oct 08
Upcoming dividend of €0.81 per share Eligible shareholders must have bought the stock before 15 October 2024. Payment date: 23 October 2024. Payout ratio and cash payout ratio are on the higher end at 98% and 84% respectively. Trailing yield: 3.4%. Lower than top quartile of Finnish dividend payers (6.0%). Higher than average of industry peers (2.3%). Buy Or Sell Opportunity • Oct 03
Now 20% undervalued Over the last 90 days, the stock has risen 15% to €47.65. The fair value is estimated to be €59.66, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 7.3% over the last 3 years. Earnings per share has grown by 5.7%. For the next 3 years, revenue is forecast to grow by 10% per annum. Earnings are also forecast to grow by 13% per annum over the same time period. Recent Insider Transactions • Aug 14
Insider recently sold €440k worth of stock On the 12th of August, Satu Ahomäki sold around 10k shares on-market at roughly €43.99 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €512k more than they bought in the last 12 months. Reported Earnings • Aug 09
Second quarter 2024 earnings released: EPS: €0.37 (vs €0.26 in 2Q 2023) Second quarter 2024 results: EPS: €0.37 (up from €0.26 in 2Q 2023). Revenue: €328.2m (up 13% from 2Q 2023). Net income: €52.0m (up 43% from 2Q 2023). Profit margin: 16% (up from 13% in 2Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 7.8% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 8% per year. Announcement • Aug 09
Orion Oyj, Annual General Meeting, Apr 03, 2025 Orion Oyj, Annual General Meeting, Apr 03, 2025. Announcement • Jul 17
Orion Announces Phase III Aranote Trial of Darolutamide in Combination with Androgen Deprivation Therapy in Men with Metastatic Hormone-Sensitive Prostate Cancer Meets Primary Endpoint Orion announced Phase III ARANOTE trial of darolutamide in combination with androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer meets primary endpoint. Orion and Bayer’s Phase III ARANOTE trial meets primary endpoint, significantly increasing radiological progression-free survival with darolutamide + androgen deprivation therapy compared to placebo plus ADT. Safety analysis shows darolutamide plus ADT to be comparable to placebo plus ADT, reconfirming the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials. Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal phase III studies in metastatic hormone-sensitive prostate cancer. Bayer plans to present the pivotal data at a forthcoming scientific congress and prepare for submission with health authorities globally to extend the indication of darolutamide. The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer, has met its primary endpoint of rPFS. Darolutamide plus ADT significantly increased rPFS compared to placebo plus ADT. The safety data were comparable between both treatment arms and reconfirm the established tolerability profile of darolutamide in advanced prostate cancer. Darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer, who are at high risk of developing metastatic disease, and patients with metastatic hormone-sensitive prostate cancer Detailed results of the ARANOTE trial are planned to be presented at a forthcoming scientific congress. Bayer plans to submit the data from the study to relevant global health authorities to support expanded use of darolutamide in men with mHSPC. ARANOTE is part of a robust clinical development program investigating darolutamide across various stages of prostate cancer, which includes the Phase III ARASTEP trial evaluating darolutamide plus ADT versus ADT alone in hormone-sensitive high-risk biochemical recurrence prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. A total of 669 patients were randomized to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Major Estimate Revision • Jul 08
Consensus EPS estimates increase by 11% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from €1.38b to €1.44b. EPS estimate increased from €1.73 to €1.92 per share. Net income forecast to grow 22% next year vs 24% growth forecast for Pharmaceuticals industry in Finland. Consensus price target broadly unchanged at €38.60. Share price was steady at €41.53 over the past week. Announcement • Jul 02
Orion Oyj Revises Earnings Guidance for the Year 2024 Orion Oyj revised earnings guidance for the year 2024. For the year, the company's Operating profit is estimated to be EUR 350 million to EUR 380 million compared with previous guidance of EUR 280 million to EUR 310 million. Net sales are estimated to be EUR 1,440 million to EUR 1,480 million compared with previous guidance of EUR 1,340 million to EUR 1,410 million. Announcement • May 08
Orion Corporation Announces Change in Orion Group Executive Management Board as of 31 May 2025 Olli Huotari, Senior Vice President responsible for Corporate Functions organization (including, i.a., Communications, Compliance, Corporate Responsibility, Intellectual Property Rights, Legal Affairs and Public Affairs) of the Orion Group and Secretary to the Board of Directors of Orion Corporation, and a member of the Executive Management Board of the Orion Group has informed the company of his decision to leave Orion. Orion will start a recruiting process of the successor to Olli Huotari. In order to secure a proper transition of responsibilities to his successor, Orion and Huotari have agreed that Huotari will continue in his current positions at Orion (including the membership of the Executive Management Board of the Orion Group) until 31 May 2025, after which he will leave the company. Announcement • Apr 28
Orion Oyj Revises Earnings Guidance for the Year 2024 Orion Oyj revised earnings guidance for the year 2024. For the year, the company's Operating profit is estimated to be EUR 280 million to EUR 310 million compared with previous guidance of EUR 270 million to EUR 310 million. Net sales are estimated to be EUR 1,340 million to EUR 1,410 million compared with previous guidance of EUR 1,340 million to EUR 1,410 million. 