ORION CORPORATION INTERIM REPORT 1–9/2025 28 OCTOBER 2025 at 12:00 EET Orion Group Interim Report January–September 2025 July–September 2025 Highlights Net sales totalled EUR 423.2 (July–September 2024: 471.3) million Operating profit was EUR 121.0 (202.0) millionNet sales and operating profit of the comparison period include EUR 130 million of major milestone paymentsBasic earnings per share were EUR 0.68 (1.14)Cash flow from operating activities per share was EUR 0.55 (0.48)The outlook for 2025 has been ...

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]