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Orion Group Interim Report 1-9/2020

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ORION CORPORATION            INTERIM REPORT 1-9/2020    21 OCTOBER 2020 at 12:00 noon EEST

Orion Group Interim Report 1-9/2020

This is a summary of Orion’s Interim Report 1-9/2020. The complete report is attached to this stock exchange release and is available at https://www.orion.fi/en/Orion-group/investors/financial-reviews-and-presentations/

  • Net sales were EUR 823 million (EUR 776 million in January–September 2019).
  • Operating profit was EUR 246 (198) million.
  • Both net sales and operating profit include a total of EUR 37 (47) million milestone payments.
  • Profit before taxes was EUR 245 (196) million.
  • Equity ratio was 70% (78%).
  • ROCE before taxes was 40% (32%).
  • ROE after taxes was 34% (28%).
  • Basic earnings per share were EUR 1.38 (1.10).
  • Cash flow per share before financial items was EUR 1.52 (1.28).
  • Outlook for 2020 was updated after the review period on 19 October 2020. Orion estimates that in 2020 net sales will be at a similar level as in 2019 or slightly higher than in 2019 (net sales in 2019 were EUR 1,051 million). Operating profit is estimated to be higher or clearly higher than in 2019 (in 2019 operating profit was EUR 253 million).

KEY FIGURES

7-9/207-9/19Change %1-9/201-9/19Change %1-12/19
Net sales, EUR million 250.3 283.7 -11.8% 822.7 776.5 +6.0% 1,051.0
EBITDA, EUR million 79.5 104.6 -24.0% 288.7 239.3 +20.6% 308.9
    % of net sales 31.8% 36.9% 35.1% 30.8% 29.4%
Operating profit, EUR million 65.1 90.7 -28.2% 245.9 197.8 +24.3% 252.8
    % of net sales 26.0% 32.0% 29.9% 25.5% 24.1%
Profit before taxes, EUR million 64.6 90.9 -28.9% 244.5 196.1 +24.7% 250.8
    % of net sales 25.8% 32.0% 29.7% 25.3% 23.9%
Profit for the period, EUR million 51.4 71.6 -28.2% 194.4 155.2 +25.2% 200.4
    % of net sales 20.5% 25.2% 23.6% 20.0% 19.1%
R&D expenses, EUR million 25.6 28.5 -10.2% 84.8 86.5 -2.0% 119.3
    % of net sales 10.2% 10.1% 10.3% 11.1% 11.3%
Capital expenditure, EUR million 9.3 9.3 +0.1% 30.5 28.1 +8.7% 42.6
    % of net sales 3.7% 3.3% 3.7% 3.6% 4.0%
Interest-bearing net liabilities, EUR million -140.0 -85.8 -139.1
Basic earnings per share, EUR million 0.37 0.51 -28.2% 1.38 1.10 +63.2% 1.43
Cash flow per share before financial items, EUR 0.62 0.71 -12.6% 1.52 1.28 +18.3% 1.68
Equity ratio, % 70.4% 78.2% 76.7%
Gearing, % -18.4% -12.1% -17.8%
ROCE (before taxes), % 40.1% 32.3% 29.9%
ROE (after taxes), % 33.7% 27.9% 25.8%
Average personnel during the period 3,343 3,246 +3.0% 3,251

President and CEO Timo Lappalainen:
Orion is prepared for a second wave of the COVID-19 pandemic

“The COVID-19 pandemic has accelerated in the course of the autumn in Finland, Europe and around the world. At Orion, our priority continues to be safeguarding our employees’ health and safety. Through this, we strive to secure continued manufacturing of important active pharmaceutical ingredients and drugs as well as optimal availability of drugs in the current exceptional circumstances. Ensuring patient safety in ongoing clinical trials is another key priority for us. This year we have been able to increase our stocks of finished products and raw materials, and Orion’s people have worked hard in all other aspects as well to ensure our optimal preparedness for the second wave of the pandemic.

Orion’s net sales from January to September 2020 increased slightly and our operating profit increased clearly from the comparative period. All our reporting units increased their net sales. Some of the growth is partly attributable to a strong increase in demand for pharmaceuticals in March and April in all markets caused by the ongoing COVID-19 pandemic. In several products, however, the impact of the spike in demand has levelled off in the second and third quarters, as anticipated. Furthermore, COVID-19-induced disruptions in the availability of some products have been less severe than expected.

The high capacity utilisation rate of Orion’s production facilities and reduction of scrap and inventory write-offs due to continuous development of operations as well as a favourable sales margin structure served to increase the gross margin from the comparative period. Operating expenses have been lower than in the comparative period owing to the COVID-19 pandemic, with significant reduction in travel, for example. Due to these reasons as well as the increase in net sales our operating profit increased clearly in January–September 2020.

The net sales of Orion’s intensive care sedative Dexdor® for the European market decreased from the comparative period due to generic competition. However, due to the strong demand spike in March and April, the product’s sales were well above the levels estimated at the start of the year. The sales of Simdax®, applied in the treatment of acute decompensated heart failure, remained on par with those of the comparative period. The product’s formulation patent expired in September, but generic competition is not expected to materially impact the sales of Simdax® this year.

Our Easyhaler® product family, used in the treatment of asthma and COPD, saw a marked increase in its sales in March, but subsequently the growth levelled off, and the increase in the product’s net sales from January to September was at the level anticipated at the start of the year. The net sales of the Parkinson’s drugs Stalevo® and Comtess®/Comtan® increased due to the reacquisition of their sales and distribution rights by Orion at the end of 2018 and in early 2019 as well as timing of partner deliveries. Compared with the first half of the year, the growth rate has since evened out as anticipated, and this trend is estimated to continue in the year’s remaining months.

From January to September 2020, Orion booked EUR 11 million in sales of Nubeqa®, a drug indicated for the treatment of non-metastatic castration-resistant prostate cancer. In addition, Orion has this year booked a total of EUR 28 million in milestone payments from the first commercial sales of the product in the EU and Japan. During the comparative period in August 2019, Orion booked a EUR 45 million milestone payment for the first commercial sales of the product in the USA.

The net sales of the Specialty Products unit increased, but the growth rate levelled off as expected once the March hoarding phenomenon and demand spike related to self-care products and generic prescription drugs had passed. However, the full-year sales of some products will be higher than expected at the start of the year. Additionally, the risk of COVID-19-induced lower product availability in 2020 has reduced significantly. The Animal Health unit had a very robust third quarter, partly thanks to the timing of partner deliveries, and its other business has developed well all year. Consequently, the unit’s net sales in January–September increased slightly from the comparative period. The demand for Fermion products has been good, and the production capacity has been utilised nearly in full.

The clinical Phase III REFALS trial, which was completed in July, unfortunately failed to meet its pre-specified endpoints. Therefore, Orion currently has no plans concerning the establishment of commercial operations in the United States. Orion remains focused on managing the safety and continued treatment of patients involved in the clinical trials during the COVID-19 pandemic. It is to be expected that the exceptional circumstances may delay ongoing research and development projects, and some projects have already experienced slight delays. In the period under review in September, we announced plans to revise and refocus the strategy of our research and development function. Through these changes and reorganisation measures, we aim to strengthen the company’s R&D portfolio and accelerate our research projects.

Orion has made sustainable investments amounting to tens of millions of euros per year in maintenance, refurbishment and expansion of our production facilities in Finland. We have systematically continued making these investments this year, and our tangible investments from January to September exceeded EUR 25 million."

Outlook for 2020 (provided on 19 October 2020)

Orion estimates that in 2020 net sales will be at a similar level as in 2019 or slightly higher than in 2019
(net sales in 2019 were EUR 1,051 million).

Operating profit is estimated to be higher or clearly higher than in 2019 (in 2019 operating profit was EUR 253 million).

Basis for outlook in more detail

Orion continues persistent actions to generate growth more rapidly than growth of the market in the long term.

Due to the COVID-19 pandemic the whole year international sales of Dexdor® will be clearly higher than expected at the start of the year. The demand spike of generic prescription drugs and self-care products in March has levelled off during the year as expected but the full-year sales of some products, however, will be higher than expected at the start of the year. Additionally, the risk of COVID-19-induced lower product availability in 2020 has reduced significantly. Due to these reasons, among others, Orion estimates the full-year 2020 net sales to be at a similar level as in 2019 or slightly higher than in 2019.

Mainly due to the COVID-19 pandemic the full-year operating expenses of Orion will be lower than estimated earlier. Due to the net sales that will be higher than estimated at the start of the year, favourable sales margin structure of the sold products and lower than estimated earlier operating expenses, Orion estimates the full-year 2020 operatig profit to be higher or clearly higher than in 2019. In addition to prices and product portfolio, the sales margin structure is affected by the cost level, which is improved, for example, by the high capacity utilisation rate of production facilities and the reduction of scrap and inventory write-offs.

The outlook is based on the assumption that Orion‘s own production can continue normal operations despite the COVID-19 pandemic. This requires that Orion continues to succeed in protecting its employees and employee absence rates do not significantly increase, that personal protective equipment, starting materials, intermediate products and materials are available and that the logistics chains are sufficiently functional.

The outlook does not include any income or expenses associated with possible product or company acquisitions.

Net sales

The sales of the Easyhaler® product family will continue to grow also in 2020 due to the combined formulations (budesonide-formoterol and salmeterol-fluticasone) launched in the past few years. The COVID-19 pandemic increased the demand for Easyhaler® products at least temporarily in the spring, but this is not estimated to have a material impact on overall annual sales.

Orion reacquired from Novartis the European sales and distribution rights for the Parkinson‘s drugs Stalevo® and Comtan® in December 2018 and April 2019, respectively. Except for Japan, Orion‘s arrangements with Novartis in other markets have expired or will expire during 2020 and in most of these markets, Orion has transferred the distribution to new partners. Orion sells these products through its own sales organisations in Singapore, Malesia and Thailand. After these changes, the sales of Orion‘s branded Parkinson‘s drugs (Comtess®, Comtan® and Stalevo®) are estimated to remain at the same level as in the previous year.

Generic competition for Dexdor® started in Germany in 2017 and has since expanded to almost all countries in the European Union, resulting in a decline in the sales of the product. However, the strong increase in the demand for intensive care sedatives in March and April 2020 brought about by the
COVID-19 pandemic temporarily increased the sales of the product substantially. The full-year sales are also expected to exceed the original estimate, but are unlikely to surpass the 2019 level. Even so, it is difficult to make accurate estimates on the sales of Dexdor® in 2020.

Orion has also been informed that marketing authorisation applications have been filed for a generic version of Simdax® in Europe, and that a generic dry-powder infusion concentrate of levosimendan has received marketing authorisation in a few European countries. The levosimendan used in Simdax® is a liquid infusion concentrate. It is, however, difficult to make precise estimates on the impact of generic competition on the sales of Simdax®. The formulation patent for Simdax® expired in September 2020. The expiry of product protection and start of generic competition is not estimated to materially affect Simdax® sales in 2020. 

Sales of generic products account for a significant proportion of Orion’s total sales. Towards the end of the first quarter in 2020, the COVID-19 pandemic caused significant increase in demand, but the growth in sales generated by this demand spike levelled off in the second and third quarters and is estimated to level off further in the last quarter. The full-year sales of some products, however, will be higher than expected at the start of the year. At the same time, other than COVID-19-induced availability disruptions as well as price competition in generic drugs have affected and continue to affect the net sales negatively in all markets. The risk of lower product availability in 2020 owing to the COVID-19 pandemic has reduced substantially. The prices of reference-priced prescription drugs in Finland, Orion’s biggest individual market, continued to decrease slightly in January–September 2020 compared with the corresponding period a year before.

Net sales of Orion‘s biosimilars (Remsima®, Ritemvia® and Amgevita®) have fluctuated heavily in the past few years. Their net sales were EUR 57 million in 2017, EUR 25 million in 2018 and EUR 38 million in 2019. The changes are due to varying success in national or regional tendering competitions. Tendering competitions for 2020 have been challenging for Orion, and therefore the net sales of biosimilars are estimated to decline significantly in 2020.

Collaboration agreements with other pharmaceutical companies are an important component of Orion’s business model. Agreements often include payments recorded in net sales that vary greatly from year to year. Forecasting the timing and amount of these payments is difficult. In some cases they are conditional on, for instance, the progress or findings of research projects, which are not known until studies have been completed. On the other hand, neither the outcome nor the schedule of contract negotiations is generally known before the final signing of the agreement. In 2019, milestone payments amounted to EUR 51 million, including the EUR 45 million milestone payment from Bayer for the commercialisation of the prostate cancer drug darolutamide in the United States. The outlook for 2020 includes milestone payments worth around EUR 40 million, the largest single payments among which are EUR 20 million for the commercialisation of darolutamide in the EU and EUR 8 million for its commercialisation in Japan. Of the EUR 40 million milestones included in the outlook, EUR 37 million was booked in January-September 2020.

Expenditure

Mainly due to the COVID-19 pandemic, sales and marketing expenses for the full year will be lower than estimated earlier, for example due to significantly reduced travel. A significant part of the approximately EUR 5 million expenditure previously planned for the preparation of the launch of the ALS product will not be realised. Sales and marketing expenditure for 2019–2020 includes a EUR 12 million annual depreciation related to the acquisition of the European sales and distribution rights for the Parkinson‘s drugs Stalevo® and Comtan®. Orion paid a total of USD 28 million for the transfer of the sales rights in December 2018 and in April 2019, and the investment will be depreciated over two years.

Because the registrations and launches of new products are projects that generally take more than a year, the increases in resources and other inputs required in 2020 were mainly planned during the previous year.

Research and development costs are estimated to be roughly equal to those in 2019. The expenses from the Phase III REFALS clinical trial investigating levosimendan (ODM-109) for the treatment of symptoms of amyotrophic lateral sclerosis (ALS) will slightly decline from previous year, since the trial hasl come to an end in 2020. On the other hand, investments in earlier research phases will increase. Research and development expenses partly consist of the Company’s internal fixed cost items, such as salaries and maintenance of the operating infrastructure, and partly of external variable costs. External costs arise from, among other things, long-term clinical trials, which are typically performed in clinics located in several countries. The most important clinical trials scheduled for 2020 are either continuing from the previous year or at an advanced stage of planning, therefore their cost level can be estimated rather accurately. However, the accrued costs are materially affected by collaboration arrangements and how the costs arising are allocated between Orion and its collaboration partners. For instance, Bayer is paying the majority of the darolutamide research costs.

Capital expenditure

The Group’s total capital expenditure in 2020 is expected to be higher than in 2019, when capital expenditure was EUR 43 million. However, the COVID-19 pandemic may slow down the execution of planned investments and thus slightly reduce the volume of investments originally planned for 2020.

Near-term risks and uncertainties 

The outlook is based on the assumption that Orion‘s own production can continue normal operations despite the COVID-19 pandemic. The sales Orion-manufactured products depend on the ability of production and the entire supply chain to operate at planned level. This involves numerous pandemic-related risks that may cause even material production disruptions. Such risks include the infection of employees, poor availability of personal protective equipment, poorer availability of starting materials and intermediate products as well as logistics chain disruptions.

The reacquisition of European sales and distribution rights for Stalevo® and Comtan® has generated additional sales for Orion’s branded Parkinson’s drugs since 2019. With the expiration of the Novartis contract in 2020, the distribution of these products has been handed over to new partners in most non-European markets, with the exception of Japan. Orion has started to sell these products by itself in Singapore, Malesia and Thailand. Sales will continue to be negatively affected by continued generic competition. All these changes and impacts have been taken into account in the outlook for the current year. However, they still entail uncertainty that may materially affect the accuracy of the estimate made at this stage.

The basic Dexdor® and Simdax® patents have expired. Dexdor®‘s indication patent expired at the end of March 2019 and the formulation patent for Simdax® expired in September 2020. Generic competition for Dexdor® started in Germany in 2017 and has since expanded to most countries in the European Union, turning down sales of the product. However in March-April 2020, the strong increase in demand for intensive care sedatives caused by the COVID-19 pandemic has temporarily brought a significant increase to the sales of Dexdor®. It is therefore difficult to make precise estimates on the impact of generic competition on the sales of Dexdor® in 2020. Orion has been informed that a generic levosimendan dry-powder infusion concentrate has received marketing authorisation in a few European countries. The levosimendan used in Simdax® is a liquid infusion concentrate. However, the launch of generic competition is not estimated to materially impact the sales of Simdax® in 2020.

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 pharmaceuticals markets in recent years will specifically focus on 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.

The structural exchange rate risk due to the US dollar has decreased in recent years because the share of Orion’s net sales invoiced in dollars has fallen to below ten per cent and at the same time the value of purchases in dollars has increased. The greatest exchange rate risk at present relates to European currencies such as the Swedish and Norwegian crown and British pound. However, the overall effect of the risk due to currencies of European countries will be abated by the fact that Orion has organisations of its own in most of these countries, which means that in addition to sales income, there are also costs in these currencies. Changes in the Japanese yen exchange rate have relevance due to sales of Parkinson’s drugs in Japan. The exchange rate effect related to the Russian rouble has increased due to the strong volatility of the currency. However, Russian sales are not a significant portion of Orion’s entire net sales.

Orion’s broad product range may cause risks to the delivery reliability and make it challenging to maintain the high quality standard required in production. The impact of availability disruptions on our net sales has increased in the past few years. The ongoing COVID-19 pandemic has clearly raised this risk. However, the risk of COVID-19-induced lower product availability in 2020 has reduced significantly from what was previously estimated.The travel and other restrictions in place around the world may cause disruptions to the global pharmaceutical supply and logistics chains with a delay. Authorities and key customers in different countries undertake regular and detailed inspections of development and manufacturing of drugs 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 deliver active pharmaceutical or other ingredients. 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, for example due to the COVID-19 pandemic, 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 timetables and costs of new studies that are being started are known well in advance. They therefore typically do not lead to unexpected changes in the estimated cost structure. 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. In 2014–2019 the annual payments varied from EUR 5 million to EUR 51 million. 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 outlook for 2020 includes milestone payments worth around EUR 40 million, the largest single payments among which are EUR 20 million for the commercialisation of darolutamide in the EU and EUR 8 million for its commercialisation in Japan. Of the EUR 40 million milestones included in the outlook, EUR 37 million was booked in January-September 2020.

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Wednesday, 21 October 2020 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be 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.

To participate the conference call, please dial:

Finland: +358 9 817 103 10
Sweden: +46 8 566 426 51
UK: +44 333 300 0804
USA:  +1 631 913 1422

PIN: 15529281#

Orion calendar

Financial Statement Release for 2020 Tuesday 9 February 2021
Annual General Meeting 2021 Planned to be held on Thursday 25 March 2021
Interim Report January-March 2021 Tuesday 27 April 2021
Half-Year Financial Report January-June 2021 Monday 19 July 2021
Interim Report January-September 2021 Wednesday 20 October 2021

The Financial Statements and the Report of the Board of Directors for 2020 will be published on the Company's website at the latest in week 9/2021.

Espoo, 21 October 2020

Board of Directors of Orion Corporation

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. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are neurological disorders, oncology, Finnish heritage rare diseases and respiratory diseases for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2019 amounted to EUR 1,051 million and the company had about 3,300 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.

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