Salute e Benessere
Orion Group Interim Report January–September 2024
ORION CORPORATION
INTERIM REPORT 1–9/2024
29 OCTOBER 2024 at 12:00 EET
Orion Group Interim Report January–September 2024
Key figures
President and CEO Liisa Hurme:
Nubeqa® becomes first-ever Orion-originated blockbuster
"In January–September 2024, our net sales increased by 27.6 percent to EUR 1,108.0 (868.5) million and operating profit increased by 77.9 percent to EUR 323.8 (182.0) million.
Two significant milestone payments, totalling EUR 130 million (EUR 70 million related to Nubeqa® sales and EUR 60 million related to contract conversion with MSD), contributed significantly to the strong growth in net sales and operating profit. Excluding major milestones (EUR 30 million in 2023 and EUR 130 million in 2024), net sales increased by 16.6% to EUR 978.0 (838.5) million, and operating profit increased by 27.5% to EUR 193.8 (152.0) million.
Of the individual products or product groups, Nubeqa® and Easyhaler® continued to perform well. The Animal Health business division benefited from the recovery in partner and market demand compared to the comparison period. I'm also glad that the revenue of the Generics and Consumer Health business division showed positive development. There is still work to be done to stabilise the growth of the business division, but we are heading in the right direction in implementing our strategy.
In July we, together with MSD, converted the co-development and co-commercialisation agreement for opevesostat and other candidates targeting CYP11A1 to an exclusive global license for MSD. The conversion of this collaboration into a license agreement allows Orion to focus our resources to progress our other promising development candidates while both remaining well positioned to benefit from the development and potential commercialisation of opevesostat and meeting our financial objectives. We believe MSD provides the best choice to maximise the potential of opevesostat, a compound discovered by Orion's scientists. As a result of the contract conversion, we released a EUR 60 million item from our balance sheet to the net sales and operating profit of third quarter of 2024.
The results of the ARANOTE trial, conducted together with our partner Bayer, were presented during the review period at the ESMO 2024 Congress and in The Journal of Clinical Oncology. Based on the results, Bayer has already submitted applications in the US and the EU to extend the marketing authorisation for darolutamide.
In September, we received historic news for Orion, when Bayer announced that Nubeqa's in-market sales exceeded the EUR 1 billion mark this year. This is the first time in history that an Orion-originated product reaches this significant milestone. In addition, we recorded a milestone payment of EUR 70 million related to the sale of Nubeqa for the review period. Nubeqa's sales milestone payments still have one milestone payment of EUR 180 million remaining, which we currently estimate could be achieved in 2026.
After the reporting period, in October, we decided to terminate the ODM-111 development program. Recent findings from a non-clinical toxicology study indicate that the profile of ODM-111 does not support long-term use of the molecule. Altogether we consider the therapeutic window of ODM-111 too narrow, and thus it is not feasible for Orion to continue the development program but rather focus on other promising programs in our pipeline. Also in October, our partner Marinus announced that their phase III TrustTSC trial with ganaxolone did not meet its primary endpoint, and that Marinus is discontinuing further ganaxolone clinical development. We are currently assessing our strategic next steps with ganaxolone.
We continue to strengthen Orion's early-stage research as part of our growth strategy. One indication of this is the agreement with Aitia aimed to benefit from the Gemini Digital Twins platform to discover new cancer treatments. During the reporting period, we also took an important step forward in our sustainability agenda, as the Science Based Targets initiative (SBTi) confirmed Orion's science-based near-term climate targets.
Orion's third quarter of 2024 was very eventful and I am very proud of what we at Orion have achieved ourselves and together with our great partners.”
Outlook for 2024 (updated on 11 September 2024)
Net sales are estimated to be EUR 1,470 million to EUR 1,510 million.
Operating profit is estimated to be EUR 370 million to EUR 400 million.
Previous outlook for 2024 (provided on 1 July 2024)
Net sales are estimated to be EUR 1,440 million to EUR 1,480 million.
Operating profit is estimated to be EUR 350 million to EUR 380 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 and which was recorded in Q3 2024.
In addition, both the net sales outlook and the operating profit outlook include a EUR 60 million item which Orion released from the balance sheet in Q3 2024 after Orion and MSD exercised an option in July 2024 to convert the companies' co-development and co-commercialisation agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an exclusive global license for MSD.
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 of a strongly growing product for the whole year. In addition, the EUR 70 million Nubeqa®-related milestone increases the net sales of the Innovative Medicines business division. The net sales of the business division increases also due to the EUR 60 million item that was released from the balance sheet in Q3 2024.
The 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 volume of entacapone products is recovering 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 or decline slightly in 2024. Animal Health growth is anticipated to be driven by the sedatives portfolio, products in launch phase and improving market conditions.
The 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 recent years. The overall volume of generic products is expected to grow. Due to the aforementioned reasons, the net sales of the Generic and Consumer Health business division in 2024 is assumed to be at a similar level as in 2023.
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, the EUR 60 million item that was released from the balance sheet in Q3 2024, and the EUR 70 million Nubeqa®-related sales milestone.
The 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 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 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.
Sales and marketing expenses are expected to increase mainly due to growing investments to the Easyhaler® sales and increasing Nubeqa® royalty payable as per 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. Key currencies that carry an exchange rate risk are the US dollar and 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 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 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. 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, 29 October 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.
Conference call can be joined by registering through the following link:
https://palvelu.flik.fi/teleconference/?id=50047158
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 2024 will be published on the Company's website at the latest in week 11/2025.
Espoo, 29 October 2024
Board of Directors of Orion Corporation
For additional information about the report:
Tuukka Hirvonen, Investor Relations, tel. +358 10 426 2721 or +358 50 966 2721
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 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. 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.
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