Entacapone

☝ 点击上方 一键预约 ☝   最新最热的医药健康新闻政策两会进行时，其中养老成为政府关注重点工作之一。据了解，《政府工作报告》全文共13次提到“养老”这个关键词，另有7次提及老年人相关内容。这意味着，包括慢性病药物在内的银发经济将成为热门焦点，属于老年病药物的“黄金时代”开启了。012亿老年人的医疗挑战人口老龄化加速，已经成为中国未来10-20年最大的基本面之一。与老龄化相关的银发经济，也一直都是热门话题。根据国家卫生健康委发布的《2021年度国家老龄事业发展公报》数据，截至2021年末，全国60周岁及以上老年人口2.67亿人，占总人口的18.9%；全国65周岁及以上老年人口2.01亿人，占总人口的14.2%。在这层背景下，《政府工作报告》提到的十大工作任务中有五大项涉及养老相关工作，包括养老金融、老年医疗、养老照护、养老服务、养老消费、适老化改造、养老科技、农村养老等领域。随着年龄的上升，一些代表性的老龄化疾病发病率随之提升，包括肿瘤、糖尿病、冠心病、中风、骨科、带状疱疹等。诸如老年人三高症（高血压、高血糖、高血脂）、高尿酸血症/痛风，以及存在巨大未被满足临床需求的CNS疾病，如阿尔茨海默病（俗称老年痴呆）、帕金森病，也都是不得不重视的老年人常见病。由此可见，老年医疗的重要性已经不言而喻了。图片来源：德邦证券研报02老年病药物迎来爆发期随着我国进入深度老龄化社会，国产药企加速研发心血管和代谢类疾病药物。糖尿病是我国第一大代谢类疾病，不仅患者人数过亿，市场规模也达到百亿元级别。当前我国糖尿病用药结构越发多元，胰岛素及其类似物、α-糖苷酶抑制剂和双胍类仍占据主流市场，但以GLP-1、DPP-4和SGLT-2为代表的新型药物占比不断提升。尤其GLP-1降糖药物正处于爆发期，诺和诺德的利拉鲁肽和司美格鲁肽降糖药增速显著，带动了华东医药、翰森制药、甘李药业和恒瑞医药等国产药企，争相进军GLP-1赛道。图片来源：西南证券研报我国既是糖尿病大国，也是高血压大国。根据国家心血管病中心的数据显示，我国高血压患病人数约为2.45亿。据智研咨询统计，2021年中国抗高血压药物市场规模达到约1035亿元，发展空间巨大。目前常见的降压药主要有五大类，其中以血管紧张素转化酶抑制剂（ACEI）和血管紧张素受体拮抗剂（ARB）适应证最为广泛。基于此，信立泰布局了丰富管线，其中信立坦是唯一由国内自主研发、拥有自主知识产权（1.1类新药）的ARB降压药物，已于2013年获批上市，此外还有多款降压药物在研，包括S086（NMPA已受理NDA，预计今年上市）、SAL0120，以及处于Ⅲ期临床的SAL0130（S086与氨氯地平复方制剂）等。在老年人常见的心血管领域，除抗高血压药物外，新型降脂药（胆固醇吸收抑制剂、PCSK9抑制剂）也在加速兴起。相较于阿托伐他汀等传统他汀类药物，新型降脂药的疗效和安全性更好。例如，海正药业自研的海博麦布片，是国内近年来心血管领域批准的唯一1类新药，国内首个、全球第二个口服肠道胆固醇吸收抑制剂，已于2021年6月获批上市。PCSK9抑制剂方面，信达生物的托莱西单抗已经率先获批上市，君实生物、康方生物和恒瑞医药紧随其后，均已提交同类药物的上市申请，信立泰SAL003已处于临床III期阶段。图片来源：中信建投证券研报高尿酸血症被称为是继老年人三高症后的“第四高”，而高尿酸血症又与痛风息息相关。据沙利文数据显示，2020年中国高尿酸血症及痛风患病人数为1.8亿人，预计2030年将达到2.4亿人。当下，我国痛风治疗领域呈现出百花齐放态势，在研药物类型包括尿酸盐转运蛋白（URAT1）抑制剂、XO、尿酸氧化酶等，布局者包括恒瑞医药、海创药业、康缘药业、一品红和东阳光药等超10家企业。03老年病创新疗法崛起相较于心血管和代谢类疾病，存在巨大未被满足临床需求的疾病也值得重视，包括阿尔茨海默病（AD）、帕金森病、带状疱疹等。随着人口老龄化加速，患有认知障碍的老年人数量也在快速增长。根据《中国阿尔茨海默病报告2022》显示，全国的AD患者及其他痴呆患病人数约为1314万例，约占全球数量的25.5%。但是在过去的十几年里，全球药企都在尝试攻克阿尔茨海默病，却一直屡战屡败，研发成功率低，且主要以海外药企布局为主。近年来，也有一些国内药企下场布局AD药物，其中有化学创新药，如先声药业引进的Varoglutamstat、康缘药业的氟诺哌齐片、东阳光药HEC30654和新华制药OAB-14，也有生物创新药，如恒瑞医药的Aβ单抗SHR-1707，以及中药创新药，如神威药业的塞络通、天士力的养血清脑和康弘药业的五加益智。图片来源：太平洋证券研报帕金森病是仅次于阿尔茨海默病的第二大常见中老年神经系统退行性疾病，临床表现为运动障碍，同时伴有认知障碍以及睡眠障碍等。根据《中国帕金森病治疗指南（第四版）》预计，2030年国内患者将达到500万人，占据全球帕金森病患病人数的一半。从市场角度看，我国主要的抗帕金森病药物有普拉克索片、恩他卡朋片、吡贝地尔片等，其中左旋多巴/盐酸苄丝复合制剂占据较大的市场份额，2022年用药金额超过5.44亿元。图片来源：天风证券研报当前布局帕金森病的国内药企，包括京新药业、绿叶制药等。其中，京新药业研发的索普乐®（普拉克索片及缓释片），主要用于治疗成人特发性帕金森病的体征和症状，兼具有控制帕金森病患者运动症状和预防减少运动并发症的作用，销售表现亮眼，在全国院内市场排名国产第一，2021年约占11%的市场份额。绿叶制药研发的LY03003（罗替戈汀缓释微球），是全球首个产生持续性多巴胺能刺激（CDS）的周制剂，每周一次的给药频率，更利于帕金森病患者的长期管理，目前正在中国开展III期临床试验。除治疗药物外，针对老年人疾病的国产疫苗也取得突破，带状疱疹疫苗就是其中之一。带状疱疹是由水痘-带状疱疹病毒引起的急性感染性皮肤病，发病率随年龄增大而呈显著上升，临床表现为神经痛，老年患者常较为剧烈。接种疫苗可有效预防感染。目前，全球仅有3款带状疱疹疫苗获批上市，包括进口厂家默沙东、葛兰素史克（GSK），以及拿下国产首款的百克生物。此外，包括绿竹生物、嘉晨西海、瑞科生物和康希诺等国产企业，均有布局其中。04结语可以看到，随着我国人口老龄化不断加速，政府越来越重视老年人的健康问题。与此同时，银发经济也在加速崛起，带来许多新的机遇。尤其老年病药物研发已进入快车道，创新药物不断涌现，带来了巨大的市场潜力，吸引众多国产药企争相竞逐。（来源:药智网    作者:粽哥2025）药闻康策新媒体矩阵微信公众号点击下方  一键关注  【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

ORION CORPORATION FINANCIAL STATEMENT RELEASE 1-12/2023 13 FEBRUARY 2024 at 12:00 EET Orion Group Financial Statement Release January–December 2023 Net sales totalled EUR 1,189.7 (January–December 2022: 1,340.6) million Operating profit was EUR 274.9 (439.6) millionBasic earnings per share were EUR 1.54 (2.49)Cash flow from operating activities per share was EUR 0.85 (3.09)Refined strategy and new financial targets for 2024–2028The Board of Directors proposes a dividend of EUR 1.62 per share to be paid for 2023. The dividend is proposed to be paid in two instalments.Outlook for 2024: Net sales are estimated to be EUR 1,340 million to EUR 1,410 million. Operating profit is estimated to be EUR 270 million to EUR 310 million. Key figures 10-12/23 10-12/22 Change % 1-12/23 1-12/22 Change % Net sales, EUR million 321.1 294.5 +9.0% 1,189.7 1,340.6 -11.3% EBITDA, EUR million 106.0 53.2 +99.3% 326.4 487.1 -33.0% % of net sales 33.0% 18.1% 27.4% 36.3% Operating profit, EUR million 92.9 40.7 > 100 % 274.9 439.6 -37.5% % of net sales 28.9% 13.8% 23.1% 32.8% Profit before taxes, EUR million 92.4 40.5 > 100 % 271.9 440.3 -38.3% % of net sales 28.8% 13.7% 22.9% 32.8% Profit for the period, EUR million 75.1 31.7 > 100 % 216.8 349.5 -38.0% % of net sales 23.4% 10.7% 18.2% 26.1% Research and development expenses, EUR million 36.6 38.0 -3.6% 126.9 133.2 -4.7% % of net sales 11.4% 12.9% 10.7% 9.9% Capital expenditure, excluding acquired in business combinations, EUR million 26.0 60.4 -56.9% 92.7 109.6 -15.4% % of net sales 8.1% 20.5% 7.8% 8.2% Acquired in business combination, net of cash, EUR million -0.3 0.1 82.0 -99.8% Interest-bearing net liabilities, EUR million 93.3 -118.7 > 100 % Basic earnings per share, EUR 0.54 0.23 > 100 % 1.54 2.49 -37.9% Cash flow from operating activities per share, EUR 0.35 0.04 > 100 % 0.85 3.09 -72.6% Equity ratio, % 62.3% 60.9% Gearing, % 10.5% -13.1% Return on capital employed (before taxes), % 25.3% 45.1% Return on equity (after taxes), % 24.1% 42.2% Average personnel during the period 3,599 3,472 +3.7% President and CEO Liisa Hurme: Year 2023 concluded as planned - clinical pipeline progressed and Nubeqa® showed strong growth "Year 2023 was another eventful year for Orion, with the most significant achievements being the progress of the clinical development pipeline and the strong growth of Nubeqa®. We also continued to build Orion's future step by step. It is embodied in our decisions to increase our production capacity and to open an R&D office in the US, to name a few. Our new organisational structure came into effect at the beginning of 2023 and, as expected, has already shown its benefits by allowing the business divisions to focus more on their strengths, respective markets and customers. As always, during the year we also faced some challenges and demanding projects, such as the closure of our business in Russia and the transfer of Orion Pension Fund's statutory pensions to an external pension insurance company. These were also handled very well and I would like to take this opportunity to warmly thank all our employees for their achievements and accomplishments in 2023! The R&D pipeline and Nubeqa® are also at the heart of our refined strategy. In the strategy period 2024-2028, Innovative Medicines and Nubeqa® will drive Orion's revenue and profit growth, and the other business divisions will also play an important role in the strategy. The Branded Products, Generics and Consumer Health, and Animal Health business divisions have the task of generating a stable revenue stream and pursuing growth. Fermion's key role is to manufacture active pharmaceutical ingredients for Orion's current and future innovative medicines. Our goal is that a growing revenue stream will enable the increased rational investment in R&D and other growth projects required to build Orion's future, and a growing dividend for shareholders. The updated financial targets for 2024-2028 will guide and help us to deliver on our strategy. Our clinical development pipeline progressed in a number of ways during 2023. In total, we initiated no less than three new Phase III clinical projects in prostate cancer during the year. One trial with Bayer on darolutamide and two with MSD on ODM-208. We also started a Phase IIa clinical trial with ODM-105 for the treatment of insomnia and a Phase I clinical trial with ODM-212 for the treatment of solid tumours. Other clinical trials progressed as planned during the year. The results of our Phase III ARANOTE clinical trial, conducted in collaboration with Bayer, are expected to be completed in the first half of 2024, and we plan to start Phase II clinical trials in both acute and chronic pain with our pain molecule ODM-111, a NaV 1.8 inhibitor, during 2024. Our clinical development pipeline is currently solid, especially for late-stage projects. Our aim and desire is to strengthen the earlier stage as well and bring a steadier flow of new projects into the clinical development pipeline. To this end, we have also been determined to advance and grow our early-stage research pipeline, which should eventually lead to new projects entering the clinical phase. In January–December 2023, our net sales were EUR 1,189.7 (1,340.6) million and operating profit was EUR 274.9 (439.6) million. The decline in both reported net sales and operating profit is due to a significant EUR 228 million upfront payment recorded in 2022. Excluding this upfront and its EUR 208 million net impact on profits in 2022 as well as the EUR 30.7 million item related to the transfer of the Orion Pension Fund's B fund in 2023, both net sales and operating profit increased slightly in 2023. The most important drivers for this positive development were the increase in Nubeqa® royalties, the increase in sales of the Easyhaler® product portfolio as well as EUR 30 million Nubeqa® sales milestone. Overall, 2023 progressed as expected, with the exception of lower than expected deliveries to our partners of entacapone products and some animal health products. In our outlook for 2024 Orion's net sales is estimated to be EUR 1,340 million to EUR 1,410 million and operating profit EUR 270 million to EUR 310 million. Both net sales and operating profit assume that during 2024 Orion will receive one Nubeqa® sales milestone payment of EUR 70 million. The guidance range in the operating profit estimate is mainly due to Nubeqa's sales booked by Orion and the development of R&D costs. The exact level of Nubeqa® royalties and timing of deliveries are difficult to predict and any variances from the predicted levels and timings may have notable impact on our operating profit. Over the past few years, we have been determined to increase our investment in early-stage research in line with our growth strategy. This work is now starting to bear fruit and several projects are approaching the clinical development phase. Progressing these projects will also require significantly higher R&D expenditure than in the past. At the same time, projects in the clinical development phase have advanced and will advance during 2024, which will increase project costs. However, there are uncertainties related to the progress and timing of projects, which may mean that not all the costs projected for 2024 will materialise. The assumptions behind the outlook are explained in the section of this review entitled 'Basis for outlook in more detail'. Orion enters 2024 with confidence and in a good position. We expect net sales and operating profit to improve year-on-year. In line with our refined strategy, the growing revenue stream will provide us with opportunities to invest more in R&D and other growth projects. The road is open for profitable growth!" Strategy Orion’s Board of Directors has confirmed the Company’s strategy for 2024–2028. Global trends and operating environment for pharma Industry The following key global trends drive growth opportunities and challenges in pharma industry and affect Orion’s operating environment: Demographics and aging of population: as population ages, the prevalence of various diseases increases, causing increased demand for drugs and treatments.Cost pressure in healthcare and pharmaceuticals: the share of healthcare costs of available funds continues to increase, both at national and individual level, creating needs for cost-effective drugs and treatments. Geopolitical developments are decreasing predictability and causing challenges in global supply chains.Advancements in science and technologies: personalised medicine, increased genetic and epigenetic data and developments in drug dosing and diagnostics create possibilities and markets for new treatments and therapies.Sustainability regulation and demand for sustainability: sustainability and compliance in all business sectors increasingly guide the actions and decisions of consumers, authorities and investors.Digitalisation, the use of AI and real time data: The amount and significance of data is growing, and it has become a valuable tool for generating competitive business opportunities. Societies and companies are increasingly relying on artificial intelligence, machine learning, and automation. Our purpose is building well-being Well-being means something unique for each human being in all stages of life. We draw on our century-long experience in healthcare while keeping our sights firmly set on future innovations to support you every step of your way. Our novel therapies help change the lives of patients across the globe. We serve societies in sustaining health systems with a diverse portfolio of cost-effective and value-adding drugs. Our veterinary products enable pet owners and farmers to care for their animals. Inspired by our Nordic heritage, we strive to empower people around the world to live their lives to the fullest – today and tomorrow. Orion's strategy 2024-2028, with a direction into the 2030s Orion is an innovative, research-focused pharmaceutical company with a strong Nordic heritage that serves societies and helps change lives across the globe. All business divisions play a key role in Orion’s growth strategy. The three key elements in the strategy are the following: 1) Build a customer driven portfolio through our competitive businesses: Innovative Medicines focuses on oncology and pain management, leveraging Orion’s R&D expertise in these crucial and expanding fields.Branded Products continues building on its strength and success in Respiratory and Parkinson’s disease.Generics and Consumer Health provides a large cost-effective generics portfolio complemented by value-added and complex generics to European hospitals and other selected markets and caters to customer needs with consumer health products with value propositions. Animal Health continues building a competitive portfolio for companion and livestock animals.Fermion manufactures key APIs to all business divisions. 2) Expand to new ​geographies: Strengthen European market position. ​Strengthen and expand operations in Asia Pacific including Japan. Establish operations in USA​ to build R&D and commercialisation capabilities. 3) Develop growth enablers: Orion has determined the following areas where it builds its capabilities in order for the company to achieve strategic success: Competences and culture development in accordance with Orion’s values.Safety and sustainability​ –  Prioritise patient safety and sustainability across the entire product lifecycle, positioning Orion as a trustworthy European partner, known for dependable delivery, transparency, and responsibility.​Global commercialisation capabilities – build the expertise to enable the global commercialisation of our products on a larger scale.​ ​Data driven execution excellence​ - Build expertise and operational models for a data-driven approach, optimising decision-making based on hard data. Master End-to-End value chain developing competitive advantage in every step from molecule development to marketing and distribution. The roles of the business divisions in Orion’s business portfolio: In Innovative Medicines patients with cancer and pain meet innovations and disruptive pharma to transform their lives. Innovative Medicines is the global growth driver for Orion.Branded Products provides the platform for growth in Europe & Asia. In Branded Products the target is to be an impactful player in Respiratory, Central Nervous System, and Women’s Health in Europe and Asia.Generics and Consumer Health is Orion’s solid bedrock. In Generics and Consumer Health we create everybody access to affordable quality medicines and help individuals to promote their health.Animal Health is committed to the well-being of companion animals and livestock.Fermion manufactures key APIs to all business divisions. Orion’s growth strategy in three steps according to Orion strategic roadmap: 1) Short term: Strengthen & Expand – Strengthen European and Asia Pacific market positions2) Mid-term: Build and Invest – Build and invest into global commercial assets and capabilities3) Long-term (2030s): Accelerate – Grow and maximise value of global assets Non-financial targets – Orion’s sustainability commitments We are taking proactive steps in business sustainability transformation. We address both sustainability regulations and increasing demand for sustainability, reinforcing Orion’s competitiveness and market access in a dynamic operating environment. Orion’s Sustainability Agenda is a systematic approach to sustainability across the value chain. With this, we aim to minimise our footprint and adverse impacts while enhancing our positive impacts on the environment, people, and society. Patient safety as a top priority: Patient safety has been a priority for us for a hundred years and it continues to be the cornerstone of our daily operations. We play a significant role in ensuring reliable supply of medications – even in the wake of a crisis.Active work for a better environment: We want to be the environmental leaders in our industry. We continuously raise the bar in climate and environmental responsibility, and we challenge others to follow. We are strongly heading towards achieving carbon neutrality in our own operations by 2030.Care for well-being professionals: We want to take care of our employees – professionals who put their heart and expertise in everything they do. Our workplace is inspiring. We want our people to feel well. Ethics at the core of our business: We maintain strict ethical standards and act responsibly in all situations. Together with our partners we are building a transparent and sustainable business. Financial objectives Through the financial objectives, Orion aims to develop the Group’s shareholder value and ensure financial stability and profitable growth. Orion’s financial objectives for 2024–2028 are: To grow net sales with a compound average annual growth rate (CAGR) of at least 8%. To grow operating profit faster than net sales. To maintain an equity ratio of at least 50% and to generate return on equity (ROE) of 25% or higher.To increase the dividend per share annually with a payout ratio of 50% to 100%. Achievement of these objectives requires continuous and sufficient investments in development of the product portfolio and growth. Received milestone payments which are part of Orion’s business model can generate volatility in short term growth on net sales and operating profit. Proposal by Orion Corporation’s Board of Directors on use of profit funds from the financial year 2023 Orion Corporation’s distributable funds at 31 December 2023 are EUR 596,791,619.35 of which the profit for the financial year is EUR 231,377,914.00. The Board of Directors proposes to the Annual General Meeting that a dividend of EUR 1.62 per share be paid for the financial year that ended on 31 December 2023. No dividend shall be paid on treasury shares held by the Company on the record date for dividend payment. On the date of the proposal on the distribution of profits there are 140,351,305 shares entitling to dividend, and thus the total dividend would be EUR 227,369,114.10. According to the proposal, the dividend would be paid in two instalments. The first instalment of EUR 0.81per share would be paid to a shareholder who is on the record date for the payment of the dividend, 22 March 2024, 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 3 April 2024. The second instalment of EUR 0.81 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 16 October 2024, 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 2024. The Board of Directors proposes that the Annual General Meeting would authorise 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. In addition, the Board of Directors proposes to the Annual General Meeting that EUR 350,000 of the Company’s distributable funds be donated to medical research and other purposes of public interest as decided by the Board of Directors. Any remaining distributable funds would be allocated to retained earnings. There have been no material changes in the Company’s financial position since the end of the financial year. The liquidity of the Company is good and, in the opinion of the Board of Directors, the proposed profit distribution would not compromise the liquidity of the Company. Outlook for 2024 Net sales are estimated to be EUR 1,340 million to EUR 1,410 million. Operating profit is estimated to be EUR 270 million to EUR 310 million. Basis for outlook in more detail Collaboration agreements with other pharmaceutical companies are an integral part of Orion’s business model. Agreements often include payments recorded in net sales and operating profit that vary greatly from year to year. Forecasting the timing and amount of these payments is difficult. In some cases, they are conditional on terms such as R&D outcomes which are not known until studies have been completed, the progress of R&D projects or the attainment of specified sales levels. Regarding possible new contracts under negotiation, neither the outcome nor the schedule of contract negotiations is generally known before the final signing of the agreement. Orion is eligible to receive milestone payments from Bayer based on sales of the Nubeqa® product upon meeting certain global annual sales thresholds for the first time. In 2023 Orion received one such milestone payment of EUR 30 million. The outlook for 2024 includes one Nubeqa® sales-related milestone payment of EUR 70 million which is included in both the net sales outlook and the operating profit outlook. The outlook does not include any other material milestone payments or one-offs. The outlook assumes that Orion's own production and other operations will be able to operate normally throughout the year, and the supply chains of raw materials or ready-made products are not facing significant disruptions. These and other risks are discussed in more detail under 'Near-term risks and uncertainties'. The outlook does not include income, expenses or other impacts related to any future material product or company acquisition or divestment. Milestone payments received by Orion in 2019–2023 Year 2019 2020 2021 2022 2023 EUR million 51 42 3 234 32 Net sales The outlook assumes that the net sales of Nubeqa® booked by Orion, and thus the net sales of the Innovative Medicines business division, will clearly increase in 2024. Orion’s assumption is based on forecasts received from its partner Bayer. However, it is difficult to predict the exact level of product sales and royalties for the whole year of a strongly growing product. In addition, the EUR 70 million Nubeqa®-related milestone is expected to increase the net sales of the Innovative Medicines business division. Branded Products and Animal Health business divisions are also estimated to improve their net sales in 2024. Branded Products growth is anticipated to be driven by the Easyhaler® product portfolio. The sales of entacapone products are assumed to recover somewhat after challenging year 2023. At the same time, however, the market conditions for the entacapone products continue to be tough with increasing competition and declining prices in many markets, and as a result, the sales of the entacapone products are anticipated to be flat in 2024. Animal Health growth is anticipated to be driven by sedatives portfolio, products in launch phase and improving market conditions. Generics and Consumer Health business division continues to suffer from the decline of Simdax® and dexmedetomidine products due to generic competition and falling prices, but less than in the recent years. Overall volume of generic products are expected to grow but at the same time prices are expected to decline. Due to the aforementioned reasons, the net sales of the Generic and Consumer Health business division is assumed to decrease slightly in 2024. Fermion has been operating at very near full capacity over the past few years. The share of manufacturing of the active pharmaceutical ingredients of Orion's own proprietary drugs is estimated to increase, which may restrict capacity allocated to external business. Operating profit Gross profit is expected to increase clearly driven by growing Nubeqa® royalties and the anticipated EUR 70 million Nubeqa®-related sales milestone. The wide range in the operating profit estimate is mainly due to Nubeqa's sales booked by Orion and the development of R&D costs. It is difficult to predict the exact level of royalties for the whole year of a strongly growing product. Any variance from the predicted level can have notable impact on Orion's operating profit. Also, the mechanism by which each quarter's product deliveries are always fully deducted from the next quarter's royalty payments, is causing variance to operating profit. Even though this impact on operating profit is only temporary, the timing of product deliveries may have notable impact on Orion's operating profit in one calendar year. Over the past few years, Orion has been determined to increase its investment in early-stage research in line with its growth strategy. This work is now starting to bear fruit and several projects are approaching the clinical development phase. Progressing these projects will also require significantly higher R&D expenditure than in the past. At the same time, projects in the clinical development phase have advanced and will advance during 2024, which will increase project costs. However, there are uncertainties related to the progress and timing of projects, which may mean that not all the costs projected for 2024 will materialise. Currently Orion is not booking any costs related to the development of ODM-208 and thus the outlook does not include any ODM-208 related R&D costs. Sales and marketing expenses are expected to increase mainly due to growing investments to the Easyhaler® sales and increasing Nubeqa® royalty payable due to an agreement with Endo Pharmaceuticals. Capital expenditure The Group’s total capital expenditure in 2024 is expected to be at a similar level as in 2023, when capital expenditure was EUR 93 million. The estimate of capital expenditure does not include any investments related to any future material product or company acquisition. Near-term risks and uncertainties The outlook assumes that Orion's own production and other operations will be able to operate normally. The realisation of sales of Orion-manufactured products requires that production and the related supply chains and other operations are able to operate at the planned level. There are a number of risks that could even materially disrupt Orion's production or other operations. Such risks include, for example, accidents, strikes, employee illness, poor availability of supplies, equipment, spare parts, products, energy, starting materials or semi-finished products, and the failure of logistics chains or serious disruptions to information or communication systems. Current risks to supply and logistics chains include geopolitical conflicts and unrest around the world. In addition to conflicts and unrest, any other unforeseen changes in the operating environment could cause disruptions to Orion's production, supply chains or other operations. Such risks may include accidents, strikes, natural disasters, epidemics and pandemics, wars, terrorism, cyber-attacks or hybrid influencing. Sales of individual products and also Orion’s sales in individual markets may vary, for example depending on the extent to which the ever-tougher price and other competition prevailing in pharmaceutical markets in recent years will specifically focus on Orion’s products. Changes in pharmaceutical regulation in individual markets or more broadly, for example at EU level, may affect the sales and profitability of Orion's products. Changes in overall market demand may also have negative impact on sales. Product deliveries to key partners are based on timetables that are jointly agreed in advance. Nevertheless, they can change, for example as a consequence of decisions concerning adjustments of stock levels. In addition, changes in market prices and exchange rates affect the value of deliveries. Currently no single currency is posing a material exchange rate risk for Orion. In Orion’s total net sales, the share of invoicing in US dollars has fallen to around ten per cent. At the same time, the value of purchases in dollars has increased. The weight of the US dollar will increase due to increasing sales of Nubeqa®. Other key currencies that carry an exchange rate risk are European currencies other than EUR. However, the overall effect of the risk arising from currencies of European countries will be abated by the fact that Orion has organisations of its own in most European countries, which means that in addition to sales income there are also costs in these currencies. The exchange rate performance of the Japanese yen is significant due to sales of Parkinson’s drugs in Japan. The current geopolitical conflicts and unrest, and other challenges in the global supply and logistics chains of pharmaceuticals have increased the already elevated risk of supply disruptions. Moreover, the disruptions, production volume changes and logistical challenges experienced in other industries may also have unexpected and sudden ramifications that can manifest as shortages of necessary raw materials, supplies and equipment in the chemical and pharmaceutical industries and as increases in prices. The possible rise of raw material prices and other supply chain costs deteriorates the profitability of Orion's products, since in the pharmaceuticals industry it is very difficult to pass on cost increases to the prices of own products, especially prescription medicines, particularly in Europe. If high cost inflation occurs, it will pose a risk to Orion's profitability. Authorities and key customers in different countries carry out regular and detailed inspections of drug development and manufacturing at Orion’s production sites. Any remedial actions that may be required may at least temporarily have effects that decrease delivery reliability and increase costs. Orion’s product range also contains products manufactured by other pharmaceutical companies and products that Orion manufactures on its own but for which other companies supply active pharmaceutical or other ingredients and components or parts (among these the Easyhaler® products). Possible problems related to the delivery reliability or quality of the products of those manufacturers may cause a risk to Orion’s delivery reliability. The single-channel system used for pharmaceuticals distribution in Finland, in which Orion’s products have been delivered to customers through only one wholesaler, may also cause risks to delivery reliability. Research projects always entail uncertainty factors that may either increase or decrease estimated costs. The projects may progress more slowly or faster than assumed, or they may be discontinued. Nonetheless, changes that may occur in ongoing clinical studies are reflected in costs relatively slowly and are not expected to have a material impact on earnings in the current year. Owing to the nature of the research process, the size and costs of new studies that are being started are known relatively well in advance. However, there are uncertainties in the timing and progression of any individual study. Any changes in the timing of new research or development phases that are being launched may have a material impact on the projected cost structure within a single year. Orion often undertakes the last, in other words Phase III, clinical trials in collaboration with other pharmaceutical companies. Commencement of these collaboration relationships and their structure also materially affect the schedule and cost level of research projects. Collaboration arrangements are an important component of Orion’s business model. Possible collaboration and licensing agreements related to these arrangements also often include payments to be recorded in net sales that may materially affect Orion’s financial results. The payments may be subject to conditions relating to the progress of research projects or sales or to new contracts to be signed, and whether these conditions or contracts materialise and what their timing is, will always entail uncertainties. Webcast and Conference Call A webcast and a conference call for analysts, investors and media representatives will be held on Tuesday, 13 February 2024 at 13.30 EET. A link to the live webcast is available on Orion's website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day. Confenrence call can be joined by registering through the following link: https://palvelu.flik.fi/teleconference/?id=5008942 Phone numbers and the conference ID to access the conference will be provided after the registration. In case you would like to ask a question during the conference, please dial *5 on your telephone keypad to enter the question queue. Questions can also be presented in writing through the question form of the webcast. Upcoming events Annual General Meeting 2024 Planned to be held on 20 March 2024 Interim Report January–March 2024 Thursday 25 April 2024 Half-Year Financial Report January–June 2024 Thursday 8 August 2024 Interim Report January–September 2024 Tuesday 29 October 2024 The Financial Statements and the Report of the Board of Directors for 2023 will be published on the Company's website at the latest in week 9/2024. Espoo, 13 February 2024 Board of Directors of Orion Corporation For additional information about the report: Jari Karlson, CFO, tel. +358 50 966 2883 Tuukka Hirvonen, Investor Relations, tel. +358 10 426 2721 or +358 50 966 2721 www.orion.fi/en/investors Publisher: Orion Corporation http://www.orion.fi/en http://www.twitter.com/OrionCorpIR Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and self-care products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Medicines developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion's net sales in 2023 amounted to EUR 1,190 million and the company had about 3,600 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki. Attachment Orion Financial Statement Release 2023