Orion Group Financial Statement Release January–December 2023

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) million
• Basic 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 2024–2028
• The 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

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 positions
2) Mid-term: Build and Invest – Build and invest into global commercial assets and capabilities
3) 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

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

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