Financial Performance - In Q4 2025, net sales increased by 60.1% to EUR 695.3 million compared to EUR 434.4 million in Q4 2024 [1] - Operating profit for Q4 2025 was EUR 328.1 million, more than tripling from EUR 92.7 million in Q4 2024 [2] - For the full year 2025, net sales reached EUR 1,889.5 million, a 22.5% increase from EUR 1,542.4 million in 2024 [1] - Full year operating profit was EUR 631.6 million, up 51.6% from EUR 416.6 million in 2024 [1] - Basic earnings per share for 2025 were EUR 3.56, a 51.5% increase from EUR 2.35 in 2024 [1] Business Divisions - The Innovative Medicines division saw net sales more than double in Q4 2025, driven by a EUR 180 million milestone and strong Nubeqa® sales [3] - The Branded Products and Generics and Consumer Health divisions also maintained solid growth, supported by high-quality portfolios [4] - The Animal Health division continued to perform well, contributing to overall sales stability [4] Research and Development - Orion initiated a phase 2 trial of ODM-212, a TEAD inhibitor, focusing on rare cancers, with plans to expand the program in 2026 [5] - A second phase 3 trial with levosimendan for pulmonary hypertension was also initiated by partner Tenax [5] Future Outlook - For 2026, net sales are estimated to be between EUR 1,900 million and EUR 2,100 million, with operating profit expected to range from EUR 550 million to EUR 750 million [12] - The growth in 2026 is anticipated to be driven by increasing Nubeqa® royalties and product sales [16] - The Branded Products division is expected to grow, particularly in the Respiratory therapy area and the Easyhaler® product portfolio [17] Dividend Proposal - The Board of Directors proposed a dividend of EUR 1.80 per share for 2025, to be paid in two instalments [7][8] - The first instalment of EUR 0.90 is proposed to be paid on April 2, 2026, and the second instalment on October 27, 2026 [8]

ORION CORPORATION STOCK EXCHANGE RELEASE 14 JANUARY 2026 at 16:00 EET Orion updates time estimate for the potential related to the annual Nubeqa® net sales recorded by Orion As the company announced earlier today on 14 January 2026, the Nubeqa® product has become Orion's largest product by far, and its financial significance for the company will increase further. For this reason, Orion decided to provide an estimate of the net sales potential of Nubeqa®. As noted earlier, based on scenario planning with p ...

Core Insights - Orion Corporation estimates that annual net sales of its product Nubeqa® could exceed EUR 1 billion in the future, highlighting its significance as the company's largest product [1] - The company's outlook for 2026 projects net sales between EUR 1,900 million and EUR 2,100 million, with operating profit estimated between EUR 550 million and EUR 750 million [2] - Nubeqa® is identified as the primary driver for net sales and operating profit growth in 2026, with expectations for continued strong sales growth [3] Financial Projections - The estimated net sales for 2026 range from EUR 1,900 million to EUR 2,100 million, indicating a robust growth trajectory for the company [2] - Operating profit for the same period is projected to be between EUR 550 million and EUR 750 million, reflecting the financial health of the company [2] - The outlook does not account for any significant milestone payments, suggesting that the projections are based on core product sales [3] Product Significance - Nubeqa® has become the largest product for Orion, and its financial impact is expected to grow further, prompting the company to provide a sales potential estimate [1] - The sales potential of Nubeqa® is influenced by various factors, including regulatory and market conditions, as well as product indications [1]

Core Viewpoint - Orion Corporation will receive a milestone payment of EUR 180 million related to Nubeqa® sales, impacting its financial outlook for 2025 [1] Financial Outlook Update - The new full-year outlook for 2025 estimates net sales to be between EUR 1,820 million and EUR 1,900 million [2] - Operating profit for 2025 is estimated to be between EUR 590 million and EUR 670 million [2] Previous Financial Outlook - The previous full-year outlook for 2025 estimated net sales to be between EUR 1,640 million and EUR 1,720 million [3] - Operating profit was estimated to be between EUR 410 million and EUR 490 million [3] Company Overview - Orion Corporation is a Nordic pharmaceutical company with over a hundred years of experience, focusing on human and veterinary pharmaceuticals [3] - The company has a diverse portfolio including proprietary and generic medicines, with core therapy areas in oncology and pain [3] - In 2024, Orion's net sales were EUR 1,542 million, employing approximately 3,700 professionals globally [3]

Core Insights - The company reported a decline in net sales and operating profit for Q3 2025, primarily due to the absence of major milestone payments that were recorded in the previous year [3][4][6] - Despite the reported decline, underlying net sales and operating profit showed significant growth when excluding major milestone payments [3][4] - The company has specified its outlook for 2025, projecting net sales between EUR 1,640 million and EUR 1,720 million, and operating profit between EUR 410 million and EUR 490 million [6][8] Financial Performance - Q3 2025 net sales were EUR 423.2 million, down 10.2% from EUR 471.3 million in Q3 2024 [2] - Q3 2025 operating profit was EUR 121.0 million, a decrease of 40.1% from EUR 202.0 million in Q3 2024 [2] - Basic earnings per share for Q3 2025 were EUR 0.68, down 40.4% from EUR 1.14 in Q3 2024 [2] - Research and development expenses increased by 35.8% in Q3 2025, totaling EUR 49.8 million [2] Business Segments - The Innovative Medicines division experienced a decline in reported net sales due to the absence of major milestone payments, although Nubeqa showed strong growth [4] - The Generics and Consumer Health divisions continued to grow solidly, while growth in Branded Products and Animal Health was more moderate [4] - The company anticipates growth in the Branded Products division driven by the Easyhaler product portfolio and other products [14] Market and Regulatory Developments - The European Commission approved darolutamide for use in patients with metastatic hormone-sensitive prostate cancer, which is expected to support Nubeqa's growth [5] - The company does not foresee a material impact from U.S. tariffs on its operations for the current year [5] Research and Development Focus - The company has discontinued the development of ODM-105 for insomnia due to lack of efficacy in clinical trials and will focus on advancing other assets [7] - Orion aims to initiate a Phase 2 program with ODM-212 in oncology next year and plans to bring at least one biological candidate to clinical development [7][8] Capital Expenditure and Financial Outlook - Capital expenditure is expected to grow in 2025, reflecting the company's commitment to strengthening its research and development pipeline [18] - The outlook for 2025 has been revised to reflect anticipated growth in net sales and operating profit, excluding any material milestone payments [6][11]

Core Insights - The European Commission has granted marketing authorization for darolutamide, an oral androgen receptor inhibitor, in combination with androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer [2][8] - The approval is based on the positive results from the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo [2][7] Company Overview - Darolutamide, marketed as Nubeqa®, is developed jointly by Orion and Bayer and is already approved in over 85 countries for various indications related to prostate cancer [3][8] - Orion Corporation is a Nordic pharmaceutical company with a focus on oncology and pain management, employing approximately 3,700 professionals and generating net sales of EUR 1,542 million in 2024 [15][17] Industry Context - Prostate cancer is the second most common cancer among men globally, with an estimated 1.5 million new cases diagnosed in 2022 and projected to rise to 2.9 million by 2040 [4] - The ARANOTE trial involved 669 patients and aimed to assess the efficacy and safety of darolutamide plus ADT, with the primary endpoint being radiological progression-free survival [5][6]

Core Insights - Orion Corporation reported significant growth in net sales and operating profit for the first half of 2025, with net sales increasing by 21.1% to EUR 771.0 million and operating profit rising by 49.8% to EUR 182.5 million [1][4][8] - The company upgraded its outlook for 2025, estimating net sales between EUR 1,630 million and EUR 1,730 million, and operating profit between EUR 400 million and EUR 500 million [4][8] Financial Performance - In Q2 2025, net sales reached EUR 416.5 million, a 26.9% increase from EUR 328.2 million in Q2 2024 [1][4] - EBITDA for Q2 2025 was EUR 118.6 million, up 50.6% from EUR 78.8 million in Q2 2024, representing 28.5% of net sales [1][4] - Basic earnings per share for Q2 2025 were EUR 0.59, compared to EUR 0.37 in Q2 2024, marking a 58.7% increase [1][4] Business Segments - The performance of Nubeqa® was highlighted as a key driver of growth, with both royalty income and product sales showing strong increases [3][4] - The Branded Products and Animal Health divisions also reported double-digit growth, contributing to the overall positive performance [4][5] Research and Development - Research and development expenses increased by 12.5% to EUR 49.1 million in Q2 2025, reflecting the company's commitment to innovation [1][4] - The company opened a new research and development center in Cambridge, UK, and expanded collaborations in various business areas [6][7] Market Outlook - The outlook for 2025 anticipates continued growth in Nubeqa® royalties and product sales, although predicting exact levels remains challenging [12][14] - The Branded Products division is expected to grow, driven by the Easyhaler® product portfolio and other products, while the Animal Health division is anticipated to see slight growth [13]

Core Viewpoint - Orion Corporation has upgraded its full-year outlook for 2025 due to better-than-expected product sales and royalty income in the first half of the year, which is anticipated to continue for the remainder of the year [1][2]. Financial Outlook - The new full-year outlook estimates net sales to be between EUR 1,630 million and EUR 1,730 million, and operating profit to be between EUR 400 million and EUR 500 million [3]. - The previous outlook estimated net sales between EUR 1,550 million and EUR 1,650 million, and operating profit between EUR 350 million and EUR 450 million [4]. Milestone Payments - The 2025 outlook does not include any material milestone payments, although Orion is entitled to receive a milestone payment of EUR 180 million from Bayer related to the sale of Nubeqa® [2]. - There is uncertainty regarding the timing of this milestone payment, which is why it has not been included in the 2025 outlook estimate [2].

Core Insights - The U.S. FDA has approved darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC), marking the third indication for this drug [2][9] - The approval is based on the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT [2][10] - Darolutamide is already approved in over 85 markets globally for various indications related to prostate cancer, including mHSPC and non-metastatic castration-resistant prostate cancer (nmCRPC) [5][6] Company Overview - Darolutamide, marketed as Nubeqa®, achieved blockbuster status with annual sales of EUR 1.52 billion reported by Bayer for the full year of 2024 [6] - The drug is developed jointly by Orion and Bayer, indicating a strong collaboration in the oncology sector [6][11] - Orion Corporation has a robust clinical development program for darolutamide, exploring its efficacy across various stages of prostate cancer [13] Industry Context - Prostate cancer is the second most common cancer in men, with an estimated 1.5 million diagnoses and approximately 397,000 deaths worldwide in 2022 [4] - The incidence of prostate cancer is projected to rise to 2.9 million by 2040, highlighting the growing need for effective treatment options [4] - The ARANOTE trial involved 669 patients and assessed the efficacy and safety of darolutamide plus ADT, reinforcing the drug's established safety profile [7][8]