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Orion Group Half-Year Financial Report January-June 2018

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ORION CORPORATION   HALF-YEAR FINANCIAL REPORT JANUARY-JUNE 2018   18 JULY 2018 at 12:00 EEST

Orion Group Half-Year Financial Report January-June 2018

Orion's net sales for continuing operations in January-June 2018 totalled EUR 493 million
(net sales in January-June 2017 were EUR 526 million).

  • Operating profit for continuing operations was EUR 140 (159) million.
  • Profit for continuing operations before taxes was EUR 137 (155) million.
  • Equity ratio was 67% (58%).
  • ROCE before taxes was 65% (44%).
  • ROE after taxes was 70% (42%).
  • Basic earnings per share for continuing operations were EUR 0.78 (0.87) and basic earnings per share including also discontinued operations were EUR 1.73 (0.90).
  • Cash flow per share before financial items was EUR 1.75 (0.40).
  • Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business) on 21 April 2018. The closing of the transaction took place on 30 April 2018. Following the transaction, the Group now has only one reporting segment, Pharmaceuticals business. In this report, Orion Diagnostica business is reported as a discontinued operation, and as a rule, the report only covers continuing operations.
  • Outlook remains unchanged: Orion estimates that in 2018 the net sales excluding Orion Diagnostica will be at the same level or slightly lower than in 2017 and the operating profit excluding Orion Diagnostica and material capital gains is estimated to be lower than in 2017. The complete outlook estimate and the basis for it can be found in this report under 'Outlook for 2018' and 'Basis for outlook'.

            

ORION'S KEY FIGURES FOR THE REVIEW PERIOD

Continuing operations 4-6/18 4-6/17 Change % 1-6/18 1-6/17 Change % 1-12/17
Net sales, EUR million 246.1 260.7 -5.6% 493.3 526.1 -6.2% 1,033.6
Operating profit, EUR million 69.7 70.5 -1.1% 139.5 158.7 -12.1% 284.1
  % of net sales 28.3% 27.1%   28.3% 30.2%   27.5%
Profit before taxes, EUR million 68.7 69.3 -1.0% 137.3 154.7 -11.2% 277.7
  % of net sales 27.9% 26.6%   27.8% 29.4%   26.9%
Income tax expense, EUR million 13.1 14.1 -6.9% 28.0 32.7 -14.4% 58.6
R&D expenses, EUR million 26.0 25.0 +4.1% 51.7 49.3 +4.9% 99.1
  % of net sales 10.6% 9.6%   10.5% 9.4%   9.6%
Capital expenditure, EUR million 3.1 23.6 -86.9% 19.8 38.6 -48.8% 75.0
  % of net sales 1.3% 9.0%   4.0% 7.3%   7.2%
Basic earnings per share, EUR 0.40 0.39 +2.6% 0.78 0.87 -10.3% 1.56
Diluted earnings per share, EUR 0.40 0.39 +2.6% 0.78 0.87 -10.3% 1.56
Personnel at the end of the period       3,279 3,340 -1.8% 3,182
Average personnel during the period       3,187 3,231 -1.3% 3,226


                 
Continuing and discontinued operations 4-6/18 4-6/17 Change % 1-6/18 1-6/17 Change % 1-12/17
Assets total, EUR million       1,072.9 947.5 +9.8% 1,055.5
Equity ratio, %       67.1% 58.4%   64.6%
Gearing, %       -7.7% 15.2%   -1.9%
Interest-bearing liabilities, EUR million       151.4 151.4   151.3
Non-interest-bearing liabilities, EUR million       219.1 245.8 -10.9% 224.5
Cash and cash equivalents and money market investments, EUR million       205.3 67.7 +203.3% 164.1
ROCE (before taxes), %       65.4% 43.9%   36.2%
ROE (after taxes), %       70.3% 42.5%   34.2%
Basic earnings per share, EUR 1.32 0.40 +228.8% 1.73 0.90 +91.4% 1.61
Diluted earnings per share, EUR 1.32 0.40 +228.8% 1.73 0.90 +91.4% 1.61
Cash flow per share before financial items, EUR 1.36 0.07   1.75 0.40 +334.3% 1.09
Equity per share, EUR       4.99 3.91 +27.5% 4.83
Personnel expenses, EUR million       106.3 112.1 -5.2% 218.1
               
Discontinued operations 4-6/18 4-6/17 Change % 1-6/18 1-6/17 Change % 1-12/17
Profit for the period as stated in the consolidated statement of comprehensive income, EUR million 130.1 1.2   133.4 4.7   6.9
Capital gain, EUR million 128.4     128.4      
Sales-related expenses, EUR million 0.8     0.8      
Item related to transfer of defined benefit pension plans, EUR million -4.5     -4.5      
Basic earnings per share, EUR 0.92 0.01   0.95 0.03   0.05
Diluted earnings per share, EUR 0.92 0.01   0.95 0.03   0.05

 


President and CEO Timo Lappalainen:

Continuing to build the future

"Our profitability was good in the first half of the year. The operating profit margin for continuing operations excluding the items associated with the sale of Orion Diagnostica was 28%, and above our financial target. Our cash flow was stronger than in the comparative period. Our research projects and product marketing authorisation applications have progressed, which supports our growth in the long term. Orion has three ongoing Phase III clinical trials, and the results from the first one are expected this autumn.

The sale of Orion Diagnostica that was completed at the end of April provided us with EUR 128 million in capital gain and additionally income of approximately EUR 5 million due to the departure of Orion Diagnostica from the Orion pension fund. The sale process incurred expenses amounting to approximately EUR one million. All of these items are reported as part of discontinued operations. The sale of Orion Diagnostica will allow us to further focus on growth and achieving our financial goals. Orion is currently working on numerous projects that target growth in our core area of the Pharmaceuticals business. For example, we are actively evaluating late stage in-licensing opportunities. We also continue to invest in our own research and development activities, with new clinical trials, for example. The capital gain from the transaction will strengthen our equity position and maintain our ability to achieve our dividend distribution objective.

The net sales and operating profit for our continuing operations fell behind from the exceptionally strong comparative period due to generic competition, tightening price competition especially in Finland, lower sales of biosimilars, smaller milestone payments and royalties and unfavourable exchange rate changes.

The growth of the Easyhaler product family has remained strong especially for our budesonide-formoterol product. The first national marketing authorisations for our other combined formulation, the salmeterol-fluticasone Easyhaler, have now been received, and we are preparing to launch the product in the first countries in the second half of the year. The significance of the Easyhaler product family to Orion is clearly increasing.
 
Sales of Simdax, a drug for treatment of acute decompensated heart failure, took a positive turn again after a decline in the first quarter, and sales in the first half-year were at the comparative period's level. Net sales of Dexdor intensive care sedative continued to grow in most markets despite the generic competition expanding in Europe. As a whole, net sales of Dexdor were at the previous year's level.

Sales of the branded Parkinson drugs saw an unusual increase from the comparative period. However, the increase is explained by the timing of deliveries. In the longer term, we expect sales to continue to decrease, as the products have generic competition in practically all markets.

Sales of Specialty Products decreased in Finland and Scandinavia. In Finland, price competition has increased following the change made last year to the pricing system for substitutable prescription drugs by narrowing of the so-called price band. We expect the narrowing of the price band to decrease sales in Finland by approximately EUR 15 million in 2018.


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The sales of Remsima biosimilar (infliximab), a driver of Specialty Products sales growth last year, were lower than in the comparative period, because Orion did not win national tendering competitions in Denmark and Norway since the comparative period. Sales development of Remsima will continue to fluctuate depending on our success in tendering competitions also in the future. In the near future, our biosimilar offer will expand by a third product: in the review period, we signed an agreement with Celltrion on the sales and marketing of the trastuzumab biosimilar.

Fermion, the manufacturer of active pharmaceutical ingredients, completed a significant expansion investment of more than EUR 30 million at its Hanko manufacturing plant in June. With the new facility, Fermion has ensured its preparedness to meet increasing global demand for active ingredients. In addition, it supports our aim to captively produce the active ingredients for Orion's in-house developed proprietary drugs.

The Phase III clinical trial (ARAMIS) on darolutamide (ODM-201) for the treatment of non-metastatic castration-resistant prostate cancer is progressing on schedule. Patient recruitment is completed, and the estimated primary completion date of the trial is in September. Our second darolutamide research project, Phase III clinical trial (ARASENS), is on track, and patient recruitment is now finalized also for this trial. Estimated to be completed in 2022, the ARASENS trial evaluates darolutamide in the treatment of patients with metastatic hormone-sensitive prostate cancer. Both research projects are carried out in collaboration with Bayer.

In July, Orion recruited the first patients in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS). We are conducting the trial on our own and investing approximately EUR 60 million in it over the next three years. Orally administered levosimendan has now been granted an Orphan Drug Designation both in the United States and in the European Union.

We have completed the Phase II clinical trial with a drug candidate for the treatment of symptoms of Parkinson's disease in which a new levodopa/carbidopa formulation is combined with the COMT inhibitor (ODM-104) developed by Orion. The primary endpoint of the trial was reached. We continue to analyse the results and evaluate moving on to Phase III. We are looking for a potential collaboration partner for this trial.

The outlook remains unchanged. Orion estimates that in 2018 the net sales excluding Orion Diagnostica will be at the same level or slightly lower than in 2017 and the operating profit excluding Orion Diagnostica and material capital gains is estimated to be lower than in 2017. The complete outlook estimate and the basis for it can be found in this report under 'Outlook for 2018' and 'Basis for outlook'."


Events during the period

On 3 April 2018, Orion announced a status update of the Phase III clinical ARAMIS trial of darolutamide (ODM-201). The estimated primary completion date is in September 2018.

On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business) to an investment fund managed by Axcel Management A/S. The closing of the transaction took place on 30 April 2018.

On 4 May 2018, Orion's Sustainability Report 2017 was published.
 
On 14 June 2018, the new manufacturing facility at Fermion's Hanko plant was commissioned.
The investment, which totalled over EUR 30 million, involved  the modernisation of the plant's production equipment to meet both increasing global demand for active pharmaceutical ingredients and the tightening requirements on quality, safety, the environment, and occupational health in the pharmaceutical industry.

Events after the period

On 6 July 2018, Orion announced that the first patients had been recruited in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS).


News conference and teleconference

A news conference and teleconference on the published results will be held on Wednesday 18 July 2018 at 13:30 EEST at Orion's head office (address: Orionintie 1A, Espoo). President and CEO Timo Lappalainen will give a brief presentation in English on the financial review.

The event can be followed as a live webcast accessible on Orion's website at http://www.orion.fi/en/investors. After the presentation, questions can be asked also via teleconference in Finnish and English.

The conference call ID is 1819789 and the telephone numbers to participate in the teleconference are:
 
Finland: +358 (0)9 7479 0361
Sweden: +46 (0)8 5033 6574
United Kingdom: +44 (0)330 336 9105
United States: +1 323-794-2093

News conference recordings

A recording of the webcast of the event in English and a recording of the presentation by the President and CEO in Finnish will be published on Orion's website during Wednesday 18 July 2018.

Financial report material

Financial reports and related presentation material will be available at http://www.orion.fi/en/investors promptly after publication. The website also has a form for subscribing to Orion's releases.

Dates in Orion Calendar 2018-2019

Interim Report January-September 2018 
Financial Statement Release for 2018
Annual General Meeting 2019
Interim Report January-March 2019
Half-Year Financial Report January-June 2019
Interim Report January-September 2019
Wednesday 24 October 2018
Wednesday 6 February 2019
Planned to be held on Tuesday 26 March 2019
Thursday 25 April 2019
Wednesday 17 July 2019
Wednesday 23 October 2019

The Financial Statements and Report by the Board of Directors for 2018 will be published on the Company's website at the latest in week 10/2019.

For additional information about the report:

Jari Karlson, CFO                                       tel. +358 50 966 2883
Lilli Riikonen, Communications Manager        tel. +358 50 966 2319


http://www.orion.fi/en/investors

Financial review for 1 January - 30 June 2018

On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division) to an investment fund managed by Axcel Management A/S. The transaction was closed on 30 April 2018.

Following the transaction, in the Financial review and the tables of the Half-Year Financial Report, Orion Diagnostica business is reported as a discontinued operation and as a rule, the report only covers continuing operations. Comments and figures related to discontinued operations are listed separately.

The Group currently only has one segment, the Pharmaceuticals business.

Net sales

Orion Group's net sales in January-June 2018 totalled EUR 493 million (EUR 526 million in January-June 2017), a decrease of 6%.

The decrease in net sales was due to generic competition, tightening price competition especially in Finland, lower sales of biosimilars, smaller milestone payments and royalties than in the comparison period and unfavourable exchange rate changes.

Operating profit

The Orion Group's operating profit was down by 12% at EUR 140 (159) million.

Gross profit from product sales was, mostly due to decline in sales, EUR 12 million lower than in the comparison period. The single greatest cause for the decline were exchange rates, with a net negative effect of EUR 13 million on net sales and EUR 9 million on the gross margin.

Milestone payments and royalties were also lower than in the comparative period. Milestone payments accounted for EUR 3 (8) million and royalties for EUR 9 (12) million of net sales and operating profit.

Profit impact of the sale of Orion Diagnostica

Items related to the sale of Orion Diagnostica and the profit generated by Orion Diagnostica for the period from 1 January to 30 April 2018 are entered as a discontinued operation. A capital gain of EUR 128 million was booked for the transaction. The departure of Orion Diagnostica from the Orion pension fund caused one-off income of EUR 5 million and the transaction process incurred expenses of approximately EUR one million.

Operating expenses

The Group's sales and marketing expenses totalled EUR 97 (96) million.

R&D expenses were up by 5% at EUR 52 (49) million and accounted for 10% (9%) of the Group's net sales. Research projects are reported in more detail under 'Business Review'.

Administrative expenses were EUR 22 (24) million, down by 8%.

Other operating income and expenses were EUR 4 (2) million.

The Group's profit including both continuing and discontinued operations

The profit of the Group's continuing operations was EUR 109 (122) million and the profit of discontinued operations was EUR 133 (5) million.

Basic earnings per share for continuing operations were EUR 0.78 (0.87) and basic earnings per share including continuing and discontinued operations were EUR 1.73 (0.90). Equity per share was EUR 4.99 (3.91). The return on capital employed before taxes (ROCE) was 65% (44%) and the return on equity after taxes (ROE) 70% (42%).


Financial position including both continuing and discontinued operations

The Group's gearing was -8% (15%) and the equity ratio 67% (58%).

The Group's total liabilities at 30 June 2018 were EUR 370 (397) million. At the end of the period, interest-bearing liabilities amounted to EUR 151 (151) million, including EUR 1 (150) million of long-term loans.

The Group had EUR 205 (68) million of cash and cash equivalents and money market investments at the end of the period. The cash and cash equivalents are invested in short-term interest-bearing instruments issued by financially solid financial institutions and corporations.

Cash flow including both continuing and discontinued operations

Cash flow from operating activities was EUR 106 (92) million. The cash flow from investing activities was EUR 140 (-36) million following the sale of Orion Diagnostica. The cash flow from financing activities was EUR -203 (-219) million.

Capital expenditure

The Group's capital expenditure totalled EUR 20 (39) million, down by 49%. This comprised EUR 17 (32) million on property, plant and equipment and EUR 3 (7) million on intangible assets. Fermion's significant expansion investment at its Hanko manufacturing plant was completed in the period under review and the new plant was commissioned in June.

Outlook for 2018

Due to generic and price competition Orion estimates that in 2018, the net sales excluding Orion Diagnostica will be at the same level or slightly lower than in 2017 (net sales were EUR 1,034 million excluding Orion Diagnostica in 2017).

Orion continues persistent actions to generate growth. Due to the estimated sales development and these actions the operating profit excluding Orion Diagnostica and material capital gains is estimated to be lower than in 2017 (operating profit excluding Orion Diagnostica and capital gains was EUR 284 million in 2017).

As estimated earlier, Orion has recognised a EUR 128 million capital gain in other operating income from the sale of Orion Diagnostica. Due to the uncertainty relating to the variable component included in the transaction, the capital gain does not include any part of the variable component.

Basis for outlook in more detail

The outlook covers the Group's continuing operations excluding Orion Diagnostica.
 
Items related to the sale of Orion Diagnostica and the profit generated by Orion Diagnostica for the period from 1 January to 30 April 2018 are entered as part of discontinued operations. A capital gain of EUR 128 million was booked for the transaction closed on 30 April 2018. The departure of Orion Diagnostica from the Orion pension fund caused one-off income of EUR 5 million and the transaction process incurred expenses of approximately EUR one million. In addition, Orion has the possibility to receive a variable component of EUR 60 million maximum. The payment of the variable component is based on the return on investment for the buyer (investment fund managed by Axcel Management A/S) at the time of the exit. Due to the uncertainty relating to the variable component, the capital gain does not include any part of the variable component.

Net sales

Orion's branded Parkinson's drugs are Comtess®, Comtan® and Stalevo®. Generic competition to these products commenced in the United States in 2012 and has already extended to nearly all markets. As a result of the competition, Orion's sales of these products have decreased to low levels in the United States and some other markets, and competition is expected to extend gradually. Sales of the Easyhaler® product family are forecast to continue to grow. In some European countries, marketing authorisation has been granted for a generic version of Dexdor®, and it is to be assumed that generic competition to the product will gradually expand in the EU. Orion has also been informed that a marketing authorisation application has been filed for a generic version of Simdax® in Europe. The impact of generic competition on the sales of Dexdor and Simdax is still difficult to estimate at this stage. The patent for the Simdax molecule expired in September 2015 but this is still not expected to have a material impact on sales of the product in 2018. Orion is continuing actions to defend its rights.

Sales of generic products account for a significant proportion of Orion's total sales. Competition in Finland, the most important generic market for Orion, is likely to remain intense in 2018. However, product launches continue to support Orion's position as market leader in Finland. At the beginning of 2017, changes were made to the pricing system for substitutable prescription drugs in Finland by narrowing the so-called price band. The decrease in sales caused by this change was estimated at about EUR 15 million in 2017. The outlook for 2018 assumes that the change in the system and its effect in lowering prices will also be as large in 2018. The sales of reference priced pharmaceuticals declined by 9% in the Finnish pharmaceuticals market in 2017 and the sales of Orion's reference priced pharmaceuticals declined by 6% (Source: IQVIA).

In 2017, sales of the biosimilar Remsima® generated a significant portion of the growth in net sales of the Specialty Products business division. Sales of Remsima in 2018 are expected to be materially lower than in the previous year because Orion did not win the national tendering competition for 2018 in Norway, nor the national tendering competition held in autumn 2017 in Denmark. In addition, the price level has declined significantly due to intensified competition. Orion has launched a new biosimilar, Ritemvia® (rituximab). However, sales have just commenced, and the product is not expected to compensate for the decline in Remsima sales in 2018. Orion estimates that the sales potential of Ritemvia will be lower than that of Remsima.

Orion's contract manufacturing sales will significantly decline due to ending of the largest individual collaboration agreement at the end of 2017 as the collaboration partner stopped selling the product manufactured by Orion. Net sales generated by this agreement were EUR 16 million in 2017. It included, among other things, a EUR 4 million advance payment late in the year that was entered as income earlier than planned.

Collaboration agreements with other pharmaceutical companies are an important component of Orion's business model. These agreements often include payments recorded in net sales that vary greatly from year to year. Forecasting the timing and amount of payments is difficult. Possible future payments relating to agreements already made have in some cases been conditional on, for instance, the progress or findings of research projects, which are not known until studies have been completed. On the other hand, making new agreements is generally a process for which neither the schedule nor the outcome is known before the final signing of the agreement. The outlook for 2018 does not include significant individual payments related to collaboration agreements. The new IFRS 15 standard that came into force at the beginning of 2018 changes the treatment of these payments. Some of the payments received, especially payments related to sales rights, will be entered as income over a longer period of time. Until now they have generally been recognised as one-off payments in sales.


Expenditure

Marketing expenditure will be higher than in the previous year due to additional promotion of sales of the Easyhaler product portfolio in countries where the product was launched in 2017 or will be launched in 2018. Because the registrations and launches of new products are projects that take more than a year, the increases in resources and other inputs required in 2018 were planned mainly during the previous year.

Research and development costs are estimated to be slightly higher than in 2017. They are partly the Company's internal fixed cost items, such as salaries and maintenance of the operating infrastructure, and partly 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 2018 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 (ODM-201) research costs.

Investments

The Group's total capital expenditure in 2018 is expected to be lower than in 2017, when adjusted capital expenditure was EUR 75 million. The largest single ongoing investment project, the expansion of Fermion's Hanko manufacturing plant, was completed in June 2018.

Near-term risks and uncertainties

Sales of Orion's branded Parkinson's drugs will decrease in 2018 due to generic competition. The effects of the competition have been taken into account in the outlook estimate for the current year. However, the timing of the extension and intensity of generic competition to Stalevo in Europe and elsewhere still entail uncertainty that may materially affect the accuracy of the estimate made at this stage. The basic Dexdor and Simdax patents have expired. However, the products have other product protection that is still valid. In some European countries marketing authorisation has been granted for a generic version of Dexdor, and it is to be assumed that generic competition will gradually expand in the EU. Orion has also been informed that a marketing authorisation application has been filed for a generic version of Simdax in Europe. The impact of generic competition on the sales of Dexdor and Simdax is difficult to estimate at this stage. As regards Simdax, the possible generic competition is still not estimated to materially impact its sales in 2018. Orion is continuing actions to defend its rights.

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. Deliveries of Parkinson's drugs to Novartis, the most important collaboration partner, are based on timetables that are jointly agreed in advance. Nevertheless, they can change, for example as a consequence of decisions by Novartis concerning among others adjustments of stock levels. In addition, changes in market prices and exchange rates affect the value of deliveries to Novartis.

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 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 become more important as sales of Parkinson's drugs in Japan have increased. 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. 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 includes products manufactured by other pharmaceutical companies. 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 so far been delivered to customers through only one wholesaler, may also cause risks to delivery reliability. To ensure deliveries, in addition to Oriola Finland Oy, there are also other distributors temporarily distributing certain Orion products.

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 they 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 generally 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 2014-2017 the annual payments varied from EUR 8 million to EUR 39 million. The payments may be subject to certain conditions relating to the development of research projects or sales, and whether these conditions are triggered and the timing of triggering always entail uncertainties.

Orion's dividend distribution policy

Orion's dividend distribution takes into account the distributable funds and the capital expenditure and other financial requirements in the medium and long term to achieve the financial objectives.

Shares and shareholders

On 30 June 2018, Orion had a total of 141,257,828 (141,257,828) shares, of which 37,120,346
(37,266,346) were A shares and 104,137,482 (103,991,482) B shares. The Group's share capital is EUR 92,238,541.46 (92,238,541.46). At the end of June 2018, Orion held 562,440 (675,401) B shares as treasury shares. On 30 June 2018, the aggregate number of votes conferred by the A and B shares was 845,981,962 (848,643,001) excluding treasury shares.

At the end of June 2018, Orion had 74,436 (47,828) registered shareholders.

Voting rights conferred by shares

Each A share entitles its holder to twenty (20) votes at General Meetings of Shareholders and each B share one (1) vote. However, a shareholder cannot vote more than 1/20 of the aggregate number of votes from the different share classes represented at a General Meeting of Shareholders. The Company itself and Orion Pension Fund do not have the right to vote at an Orion Corporation General Meeting of Shareholders.

Both share classes, A and B, confer equal rights to the Company's assets and dividends.

Conversion of shares

The Articles of Association entitle shareholders to demand the conversion of their A shares to B shares within the limitation on the maximum number of shares of a class. No shares were converted in January-June 2018.

Trading in Orion's shares

Orion's A shares and B shares are quoted on Nasdaq Helsinki in the Large Cap group under the Healthcare sector heading under the trading codes ORNAV and ORNBV. Trading in both of the Company's share classes commenced on 3 July 2006, and information on trading in the Company's shares has been available since this date.

On 30 June 2018, the market capitalisation of the Company's shares, excluding treasury shares, was
EUR 3,329 million.

Orion shares are also traded on various alternative trading platforms in addition to Nasdaq Helsinki.


Authorisations of the Board of Directors

Orion's Board of Directors was authorised by the Annual General Meeting on 22 March 2016 to decide on acquisition of shares in the Company and on a share issue in which shares held by the Company can be conveyed. The authorisation to acquire shares was utilised during 2016.

The Board of Directors is authorised to decide on conveyance of no more than 600,000 Orion Corporation B shares held by the Company. The authorisation to issue shares is valid for five years from the decision taken by the Annual General Meeting. The terms and conditions of the authorisation were reported in more detail in a stock exchange release on 22 March 2016.

The Board of Directors is not authorised to increase the share capital or to issue bonds with warrants or convertible bonds or stock options.

Share-based incentive plans

The Group has one currently operating share-based incentive plan for key persons of the Group:
Orion Group's Long-Term Incentive Plan 2016. The plan was announced in a stock exchange release published on 2 February 2016.

Share ownership

Orion's shares are in the book-entry system maintained by Euroclear Finland, and Euroclear Finland maintains Orion's official shareholder register.

At the end of June 2018, Orion had a total of 74,436 (47,828) registered shareholders, of whom 96% (96%) were private individuals. They held 44% (38%) of the entire share stock and had 62% (60%) of the total votes. There were 43 (65) million nominee-registered and foreign-owned shares, which was 31% (46%) of all shares, and they conferred entitlement to 7% (10%) of the total votes.

At the end of June 2018, Orion held 562,440 (675,401) B shares as treasury shares, which is 0.40% (0.48%) of the Company's total share stock and 0.07% (0.08%) of the total votes.

Personnel

The average number of employees in the Orion Group in January-June 2018 was 3,187 (3,231). At the end of June 2018, the Group had a total of 3,279 (3,340) employees, of whom 2,611 (2,711) worked in Finland and 668 (629) outside Finland.

Salaries and other personnel expenses in January-June 2018 totalled EUR 100 (105) million.

Significant legal proceedings

Companies belonging to the Orion Group are parties to various legal disputes, which are not, however, considered to be significant legal proceedings for the Group.


Business review

Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division) on 21 April 2018. The transaction was closed on 30 April 2018. Following the transaction, Orion Diagnostica business is reported as a discontinued operation. The Group will have only one reporting segment, the Pharmaceuticals business. In the Half-Year Financial Report, Orion Diagnostica segment is reported as a discontinued operation and as a rule, the review only covers continuing operations.

Review of human pharmaceuticals market

Finland is the most important individual market for Orion, generating about one-third of the total net sales. According to IQVIA statistics, Finnish sales of human pharmaceuticals, including medicinal and non-medicinal products, in January-June 2018 increased 9% on the corresponding period of the previous year. Orion's human pharmaceutical sales in Finland were down by 8%, mainly due to the change made in the Finnish pricing system for substitutable prescription drugs at the beginning of 2017, which has toughened price competition. A significant share of Orion's prescription drug sales, 60%, were reference priced drugs. In the Finnish pharmaceuticals market, the sales of reference priced drugs were down by 8% and Orion's reference priced drugs by 9%.

Sales of human pharmaceuticals in Finland (medicinal and non-medicinal products):

     
EUR million   1-6/2018 1-6/2017 Change %
Total sales of human pharmaceuticals        
Market   1,329 1,215 +9%
Orion   155 169 -8%
Prescription drugs        
Market   1,120 1,015 +10%
Orion   106 120 -12%
Reference priced prescription drugs        
Market   238 258 -8%
Orion   63 69 -9%
Self-care products in pharmacy channel        
Market   209 200 +4%
Orion   49 48 +1%

Source: IQVIA pharmaceutical sales statistics 1-6/2018

Despite the challenging operating environment, Orion has maintained its position as leader in marketing pharmaceuticals in Finland: its share of the medicinal and non-medicinal products market was 12%
in January-June 2018. Orion has a particularly strong standing in the pharmacy sales of self-care products and in reference priced prescription drugs.

Orion's market share in the sales of human pharmaceuticals in Finland (medicinal and non-medicinal products):

     
Orion's market share, %   1-6/2018 1-6/2017
Human pharmaceuticals in total   12% 14%
Prescription drugs   9% 12%
Reference priced prescription drugs   26% 27%
Self-care products   23% 24%

Source: IQVIA pharmaceutical sales statistics 1-6/2018

Orion is a significant player also in the Scandinavian generics market, where according to IQVIA statistics, it was among the top three generic companies in all of its operating countries in 2017. Biosimilars are an important source of growth for generic drugs in the area.

The most important individual therapy area for Orion is still the treatment of Parkinson's disease. Orion's branded Parkinson's drugs containing entacapone (Stalevo®, Comtess® and Comtan®) account for 12% of the Group's net sales.

Total sales of Orion's branded Parkinson's drugs:

EUR or USD million   MAT3/2018 MAT3/2017 Change %
United States USD 6 8 -26%
Europe TOP 5 EUR 49 64 -24%
Japan EUR 70 79 -11%
Source: IQVIA pharmaceutical sales statistics MAT3/2018 (4/2017-3/2018)
Europe TOP 5: Germany, United Kingdom, France, Spain and Italy

Sales of Orion's branded Parkinson's drugs decreased due to generic competition and changes in exchange rates.

According to IQVIA pharmaceutical sales statistics, in Europe total sales of the most common intravenous anaesthetics and intensive care sedatives (propofol, midazolam, remifentanil and dexmedetomidine) in the 12-month period ending in March 2018 were up by 3% at EUR 548 (532) million. According to IQVIA pharmaceutical sales statistics, sales of Orion's Dexdor® intensive care sedative (dexmedetomidine) were up by 21% at EUR 65 (54) million in Europe.


Net sales and operating profit of the Pharmaceuticals business

Net sales of the Pharmaceuticals business in January-June 2018 were down by 6% at EUR 493 (526) million. The Pharmaceuticals business's operating profit was down by 11% at EUR 146 (164) million. Milestone payments and royalties accounted for EUR 12 (20) million of the net sales and operating profit.

The operating profit of the Pharmaceuticals business was 30% (31%) of the segment's net sales.

Net sales of Orion's top ten pharmaceuticals in January-June 2018 were EUR 236 (246) million. They accounted for 48% (47%) of the total net sales of the Pharmaceuticals business.

Proprietary Products

The product portfolio of Proprietary Products consists of patented prescription products in three therapy areas: central nervous system diseases, oncology and critical care, and Easyhaler® pulmonary drugs.

Net sales of the Proprietary Products business division in January-June 2018 were EUR 188 (186) million.

Orion's drugs for treatment of Parkinson's disease are Stalevo® (active ingredients carbidopa, levodopa and entacapone) and Comtess®/Comtan® (entacapone). Their total net sales in January-June 2018 were up by 4% at EUR 60 (58) million. The growth was due to the timing of deliveries and normal fluctuations between quarters. In the longer term, Orion expects Parkinson sales to continue to decrease, as the products have generic competition in practically all markets. In the United States, Orion's Parkinson's drugs have several generic competitors, and competition is increasing in Europe and also in other markets. In Japan Comtan has generic competitors, but generic competition to Stalevo has not yet commenced.

Breakdown of sales of Parkinson's drugs:

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