Orion Group Interim Report January–September 2025

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) million
• Net sales and operating profit of the comparison period include EUR 130 million of major milestone payments
• Basic 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 specified: Net sales are estimated to be EUR 1,640 million to EUR 1,720 million. Operating profit is estimated to be EUR 410 million to EUR 490 million. Previously net sales were estimated to be EUR 1,630 million to EUR 1,730 million and operating profit was estimated to be EUR 400 million to EUR 500 million.

January–September 2025 Highlights

• Net sales totalled EUR 1,194.2 (January–September 2024: 1,108.0) million
• Operating profit was EUR 303.5 (323.8) million
• Net sales and operating profit of the comparison period include EUR 130 million of major milestone payments
• Basic earnings per share were EUR 1.71 (1.83)
• Cash flow from operating activities per share was EUR 1.67 (1.46)

Key figures

President and CEO Liisa Hurme:
Our businesses continued to perform well in Q3

“In July–September 2025, our underlying (excluding major milestones) net sales increased by 24.0 percent to EUR 423.2 (341.3) million and underlying operating profit increased by 68.1 percent to EUR 121.0 (72.0) million. Our reported net sales decreased by 10.2 percent to EUR 423.2 (471.3) million and operating profit decreased by 40.1 percent to EUR 121.0 (202.0) million. The decline both in net sales and operating profit is due to major milestone payments total of EUR 130 million booked in the comparison period.

All of our largest business divisions continued on a growth path in the third quarter. The reported net sales of the Innovative Medicines business division declined from the comparison period due to the above-mentioned major milestone payments, but Nubeqa’s growth was strong again. Also the Generics and Consumer Health business division continued solid growth. The growth rates of the Branded Products and the Animal Health business divisions were slightly more moderate than in the previous quarters. This is largely explained by the timing of some deliveries which is a normal variation within our business.

The tariffs set by the United States did not yet have an impact on us in Q3, and the details of the pharmaceutical industry tariffs are still not fully clear. However, we estimate that tariffs will not have a material impact on Orion this year.

In July, the European Commission approved darolutamide in combination with androgen deprivation therapy for use in patients with metastatic hormone-sensitive prostate cancer (mHSPC). This approval contributes to reinforcing Nubeqa’s growth trajectory.

ODM-105 did not significantly improve the symptoms of insomnia compared to placebo in clinical Phase 2 trial, which is why we decided to discontinue the development of this molecule for the treatment of insomnia. We will focus our efforts and resources on advancing our other assets both in research and clinical phases. We are looking forward to start next year the Phase 2 programme with ODM-212 which has potential in a number of indications in oncology. This is why the Phase 2 programme will be extensive. Our goal is also to bring at least one of our biological candidates to the clinical development phase next year.

We have a strong focus on building Orion’s future and intend to continue investing in strengthening our research and development pipeline. Our financial targets provide us with a good framework within which we can increase our investments.”

Outlook for 2025 (specified)

Net sales are estimated to be EUR 1,640 million to EUR 1,720 million.

Operating profit is estimated to be EUR 410 million to EUR 490 million.

Previous outlook for 2025 (provided on 9 July 2025)

Net sales are estimated to be EUR 1,630 million to EUR 1,730 million.

Operating profit is estimated to be EUR 400 million to EUR 500 million.

Basis for outlook

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.

In 2024, Orion booked two material milestones totalling EUR 130 million. The outlook for 2025 does not include any material milestone payments. Orion is entitled to receive from its partner Bayer one more milestone payment related to the sale of Nubeqa®, amounting to EUR 180 million. According to Orion’s current estimate, the milestone payment could be recorded in 2026 or even already in 2025. There is a lot of uncertainty about the timing of the milestone payment, which is why it has not been included in the 2025 outlook estimate.

Milestone payments received by Orion in 2020–2024

The outlook does not include income, expenses or other impacts related to any future material product or company acquisition or divestment.

Net sales

The outlook assumes that the Nubeqa® royalties and product sales booked by Orion will clearly increase in 2025. 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 of a strongly growing product for the whole year.

The Branded Products business division is estimated to grow in 2025. Growth is anticipated to be driven by the Easyhaler® product portfolio, but also other products are expected to support the growth. Entacapone products, for example, benefit from the fact that Orion has taken over the sales of the products in Japan. The Animal Health business division is anticipated to grow slightly, with growth coming from various products. The net sales of the Generics and Consumer Health business division are estimated to be slightly higher than in 2024.

Operating profit

The underlying operating profit growth, i.e. excluding material milestones, is expected to be driven by Nubeqa® royalties. However, it is difficult to predict the exact level of royalties of a strongly growing product for the whole year. Any variance from the predicted level can have a 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 causes fluctuation in 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. Orion’s income is increasingly coming from the United States and thus changes in the US dollar exchange rate cause fluctuations in Orion’s operating profit.

Research and development costs, and in particular their timing, can also cause fluctuations in operating profit. Although the future costs of research and development projects are known quite well in advance, there are uncertainties about their timing. The start of projects may be delayed, and projects may progress faster or slower than expected. Projects may also have to be terminated, in which case the anticipated costs will not be fully realised. Orion estimates that R&D costs in 2025 will increase from 2024.

Sales and marketing expenses are expected to be at a similar level as in 2024. In 2024, sales and marketing expenses included EUR 23.5 million write down from ganaxolone. In 2025, the growth of underlying sales and marketing expenses is mainly due to growing investments to the Easyhaler® sales in Europe, ramping up the sales and sales force in Japan, and Nubeqa® royalty payable as per an agreement with Endo Pharmaceuticals.

Capital expenditure

The Group’s total capital expenditure in 2025 is expected to grow from 2024. The estimate of capital expenditure does not include any investments related to any future material product or company acquisition.

Near-term risks and uncertainties

Orion is exposed to risks that may arise from its operations or changes in the operating environment. The most significant risk factors described below can potentially have an adverse effect on Orion’s business operations, financial position or financial results. Other risks, which are currently either unknown or considered immaterial to Orion may, however, become material in the future.

Orion’s own production and other operations are exposed to risks that may materially disrupt their operations or even interrupt them at least temporarily. Such risks include, for example, accidents, damages, natural disasters, strikes, employee illness, conflicts, terrorism, cyber-attacks, hybrid influence, disruption of information or communication systems, disruption of energy supply, and disruption of supply and logistics chains. Orion’s production and business operations are dependent on global supply and logistics chains, the inaction of which may lead to low availability of finished products and raw materials, starting materials, semi-finished products, supplies, equipment and spare parts needed in production.

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 or other 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. New tariffs or other possible customs duties on Orion’s products may negatively affect the sales and profitability of Orion’s products.

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.

Key currencies that carry an exchange rate risk for Orion are the US dollar, the Swedish krona and the Polish zloty. Other significant currencies are the Danish krone and the Norwegian krone. 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 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. The possible rise of raw material prices and other supply chain costs deteriorates the profitability of Orion’s products, since in the pharmaceutical 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 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. Although the future costs of research and development projects are known quite well in advance, there are uncertainties about their timing. The start of projects may be delayed, and projects may progress faster or slower than expected having an impact on predicted costs within an individual year. Projects may also have to be terminated, in which case the anticipated costs will not be fully realised. 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. The upfront and milestone payments paid by Orion to its collaborators, which are recorded as investments in intangible assets in balance sheet, include write-down risk that may be realised if, for example, a collaborative research project fails or otherwise has to be discontinued.

Webcast and Conference Call

A webcast and a conference call for analysts, investors and media representatives will be held on Tuesday, 28 October 2025 at 13.30 EET.

A link to the live webcast is available on Orion’s website at www.orionpharma.com/investors. A recording of the event will be available on the website later the same day.

Conference call can be joined by registering through the following link:
https://palvelu.flik.fi/teleconference/?id=50050280 .

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

The Financial Statements and the Report by the Board of Directors for 2025 will be published on the Company’s website at the latest in week 10/2026.

Espoo, 28 October 2025

Board of Directors of Orion Corporation

For additional information about the report:

Tuukka Hirvonen, Head of Investor Relations, tel. +358 10 426 2721 or +358 50 966 2721

Publisher:

Orion Corporation

https://www.orionpharma.com

Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion’s net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion’s A and B shares are listed on Nasdaq Helsinki.

Attachment

• Orion Interim Report Q3 2025