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Orion Group Interim Report 1-9/2007

Orion's net sales for the first three quarters in 2007 were EUR 509.6 (478.8) million, up by 6.4% compared to the same period last year.
  •           Operating profit was EUR 154.9 (160.1) million.
  •           Profit before taxes was EUR 155.8 (160.2) million.
  •           Equity ratio was 75.7% (74.6%).
  •           Return on capital employed (ROCE) was 47.7% (52.0%).
  •           Earnings per share were EUR 0.81 (0.85).
    Orion's key figures for the review period*

    * The proforma figures for periods before 1 July 2006 are based on the comparable ones carved out from the financial statements of the demerged Orion.
    CEO Jukka Viinanen's review
    "Orion's net sales have continued to increase steadily after the previous Interim Report. Sales of the Parkinson's Disease medicines in Orion's own sales territories grew by 14%. Also the deliveries to marketing partner Novartis were higher than during the comparative period. In addition, the sales of generic prescription medicines, self-care products and veterinary medicines continued to develop positively."
    "Expenditure on research as well as selling and marketing has been increased at the pace of first quarters, as planned. Planned actions to increase investments in research as well as selling and marketing have continued like reported early this year. This has slowed down the development of the Group's EBIT. In 2007 Orion has launched clinical studies with dexmedetomidine in the sedation of patients in intensive care, with the new COMT inhibition for Parkinson's Disease, as well as with levosimendan in heart diseases of dogs. All three study programmes are ongoing. The number of product launches in Orion's own European sales units has increased and will continue to increase as a result of more efficient in-licensing operations."
    "The development of the in-market sales of Orion's most important products, those for Parkinson's Disease, continued to be positive."
    For further information, kindly contact:
    Jukka Viinanen, CEO, tel. +358 10 426 3710
    Jari Karlson, CFO, tel. +358 10 426 2883 or mobile +358 50 966 2883
    Press conference in Finnish and on-line webcast
    A press conference on the Q3/2007 results will be held today on Wednesday, 24 October 2007, starting at 14.30 EET, at the Diana Auditorium in Helsinki, address Erottajankatu 5. The language of the conference is Finnish. The event can be followed on-line through the Group's Finnish homepage at, as well as via the Kauppalehti Live web service at
    The on-demand webcast recordings of the Q3 presentations will be available at (in English) and at (in Finnish) later in the evening of 24 October 2007. The English webcast can also be accessed via or Thomson/CCBN's password-protected event management site, StreetEvents at
    Conference call in English
    A teleconference for questions and answers in English will be arranged today on Wednesday, 24 October 2007, starting at 18.00 EET (17.00 GMT). Advice to participate the conference is provided on the front page of
    Orion's events during the end of the year
    Capital Markets Day in London                                           Wednesday 21 November 2007
    Orion's publication schedule for financial reporting in 2008
    Orion Corporation will publish its financial result for 2007 on Thursday, 7 February 2008.
    The publication dates of the Interim Reports for 2008 are as follows:
    Interim Report 1-3/2008                  Friday, 25 April 2008
    Interim Report 1-6/2008                  Tuesday, 5 August 2008
    Interim Report 1-9/2008                  Tuesday, 28 October 2008
    Annual Report 2007 will be published during week 10/2008.
    The Annual General Meeting is planned to be held on Tuesday, 25 March 2008, at 14.00 EET, in Helsinki.
    Orion's financial reports and related presentation material are available on the Group's homepage at promptly after the publishing. The homepage also provides a possibility to register on Orion's mailing lists for publications and releases.

    Financial performance in 1-9/2007
    Net sales
    Orion Group's net sales for the first three quarters in 2007 were EUR 509.6 (478.8) million, up by 6.4% from the comparative period of last year. The net impact of the currency exchange rates, mainly the US dollar, was a negative EUR 6.2 million.
    The net sales of the Pharmaceuticals business were EUR 479.4 (449.1) million, up by 6.7%. The products based on the in-house R&D accounted for EUR 220.0 (206.6) million, or 46% (46%) of the business segment's total net sales. The medicines for Parkinson's Disease, i.e. Stalevo® and Comtess®/Comtan®, contributed EUR 152.6 (137.2) million, or about 32% (31%) of the total net sales of the business segment.
    The net sales of the Diagnostics business were EUR 31.5 (31.1) million.
    Operating profit
    The Pharmaceuticals business generated an EBIT of EUR 156.9 (150.4) million, up by 4.3%. The improvement in the operating profit was somewhat lower than that in the net sales, because the expenditure on research as well as selling and marketing were increased as planned.
    The Diagnostics business generated an EBIT of EUR 6.4 (6.0) million, up by 6.8%.
    In the comparative period the Group's EBIT included a capital gain of EUR 9.8 million from the divestment of residential buildings.
    Operating expenses
    The consolidated operating expenses were EUR 196.9 (180.8) million, up by 8.9% from the comparative period. Selling and marketing expenses were EUR 101.2 (93.2) million, up by 8.6%. The Group's R&D expenses were EUR 69.1 (59.9) million, up by 15.3% and representing 13.6% (12.5%) of the Group net sales. Pharmaceutical R&D expenses were EUR 66.4 million, representing about 96% of the total. The R&D function is reported in the segment review of the Pharmaceuticals business.
    Profit before taxes
    Group profit before taxes was EUR 155.8 (160.2) million. Earnings per share were EUR 0.81 (0.85). Equity per share was EUR 2.95 (2.95). Group ROCE was 47.7% (52.0%) and ROE was 35.4% (38.9%).
    Balance Sheet and financial position
    Gearing was -11.9% (-16.4%) and equity ratio was 75.7% (74.6%). Total liabilities in the Balance Sheet of
    30 September 2007 came to EUR 133.8 (141.7) million, of which interest-bearing liabilities accounted for EUR 10.6 (10.3) million.
    The Group's cash and cash equivalents were EUR 60.1 (78.6) million. The cash reserves are invested in short-term interest-bearing instruments issues by solid financial institutions and corporations.
    Cash flows
    The cash flow from operations was EUR 115.0 (104.3) million. Operating profit was slightly lower than in the comparative period, whereas working capital was EUR 21.1 million less than in the comparative period of last year.
    The cash flow used in investments was EUR -23.1 (-5.9) million. The corresponding cash flow of the comparative period had a positive impact from the sales of residential buildings in August 2006.
    The cash flow used in financing activities was EUR -141.8 (-144.0) million. The cash flow improved slightly despite higher dividend distribution compared to previous year. In addition, two significant non-recurring items affected the cash flow of the comparative period. On one hand, the repayment of short-term loans to the companies, which in the demerger became members of Oriola-KD Corporation, had a negative impact on the cash flow. On the other hand, the share capital increase and the share issue based on the executed stock options in the comparative period affected the cash flow positively.
    Capital expenditure
    The Group's capital expenditure was EUR 23.9 (18.0) million, of which machinery and equipment accounted for EUR 16.0 (11.5) million.
    Outlook for 2007
    Net sales will grow slightly from those of 2006. Sales of pharmaceuticals via Orion's own sales network will grow moderately in Finland and the markets outside Finland will continue showing growth. In-market sales of the Parkinson's Disease products will continue showing steady, although slower growth than in the previous years. Deliveries to Novartis are anticipated to be slightly higher than in 2006.
    Operating profit, excluding non-recurring items, is estimated to grow slightly from 2006, despite increasing investments in marketing and research. Marketing expenses will grow especially due to product launches by Orion's own European marketing units outside Finland.
    Research and development expenditure will be about EUR 95 million, of which pharmaceutical R&D will account for about EUR 90 million. The higher expenditure is mainly caused by the new clinical studies that have been started in 2007.
    Capital expenditure will be about EUR 35 million.
    The Finnish pharmaceutical market showed no growth in 2006 due to Finnish authorities' actions to restrain the growth. On this account, Orion's sales in Finland decreased last year. During 2007, the Finnish market has started to show slight growth. In addition, Orion's growth is boosted by new product launches. On the other hand, heavy price competition especially in substitutable prescription medicines is slowing down the total growth.
    Novartis clearly piled up its Stalevo and Comtan stocks in 2006, when Orion's deliveries to Novartis increased by over 40%, almost twice as fast as the partner's own sales. This year Novartis has not indicated to increase the stocks. Consequently, Orion's deliveries to Novartis will be only slightly higher than in 2006, despite the fact that the in-market sales of Parkinson's products will continue to grow well.
    The majority of the expenses of pharmaceutical research are caused by the clinical research phases. They are typically performed in clinics that are located in several countries, and the costs are mainly caused by the use of outsourced research services. R&D expenses also vary considerably depending on the phase in which the research programme is. In 2007, Orion has started three significant clinical study programmes, which are estimated to increase the R&D expenses by about EUR 10 million from the previous year.
    The costs of the legal proceedings regarding the patent infringement lawsuit in the USA will not have a significant impact on Orion's results for 2007.
    Short-term risks and uncertainties
    Orion is not aware of any significant risks related to the near-term outlook of the Group's financial performance.
    Product and market specific sales revenues may vary a bit depending on how the constantly tightened price and other competition in the pharmaceutical markets affects especially Orion's products. Stalevo and Comtan deliveries to Novartis are based on schedules agreed beforehand. Based on the schedules, the sales for the rest of the year can be predicted fairly accurately.
    The development of the US dollar rate has only a minor effect on Orion's results, as the great majority of the Group's total sales are invoiced in euros.
    Research projects always involve some uncertainties, which may increase or decrease the estimated costs. Projects may proceed ahead of schedule or lag behind it, or they might have to be discontinued. Changes in the studies are reflected in the costs so slowly that they do not have a significant effect on the estimated costs for the ongoing financial year.
    Orion has been informed that Abbreviated New Drug Applications (ANDA) for generic versions of Comtan and Stalevo have been submitted to the FDA in the USA. Orion has initiated legal actions with regard to the first application. As to the latter one, Orion is currently evaluating its legal options together with Novartis. As noted earlier by Orion, the realisation of generic competition before the expiration of Orion's patents in the USA is neither certain nor imminent based on, inter alia, the circumstance that the referred legal proceedings and the ANDA review process are just in their initial stage.
    Group financial objectives and dividend distribution policy
    The moderate organic growth of the net sales within the next few years is accelerated via product, product portfolio and company acquisitions. Operating profit will be increased and equity ratio is maintained at the level of at least 50%.
    In the dividend distribution Orion takes into account the distributable funds as well as the medium-long and long-term needs of capital expenditure and other financial needs required for the achievement of the financial objectives.
    Changes in the Group's management
    President and CEO of Orion Corporation Jukka Viinanen will retire on 29 February 2008 and will as of 1 January 2008 step aside from the position of President and CEO to act as a Senior Advisor to the Board of Directors of the company until his retirement. Timo Lappalainen (M.Sc. Eng.), who currently holds the position of Senior Vice President responsible for Orion's Proprietary Products and Animal Health business divisions, has been appointed as the new President and CEO of Orion Corporation as of 1 January 2008.
    The average number of personnel in the Group during the first three quarters of 2007 was 3,156 (3,064). In the end of September 2007, Orion had altogether 3,149 (3,052) employees, of which 2,656 persons were employed in Finland and 494 persons were working in other countries.
    The number of employees in the Pharmaceuticals business increased by 103 persons compared to September 2006. The number of employees in the Diagnostics business decreased by five persons compared to September 2006.
    Shares and ownership base
    The share capital of Orion Corporation is EUR 92.2 million and the total number of shares is 141,257,828, of which 52,990,035 shares are in Class A and 88,267,793 shares are in Class B at the time of publishing this review. The counter book value of each share is EUR 0.65. Each Class A share provides 20 (twenty) votes and each Class B share provides 1 (one) vote at the Annual General Meetings of the Shareholders. Both shares provide equal rights to the company's assets and dividends.
    Based on the Articles of Association, a shareholder can demand conversion of his/her Class A shares into Class B shares. During the third quarter of 2007, a total of 498,000 Class A shares were converted into Class B shares.
    Orion's Board of Directors has been authorised by the Shareholders' Meeting on 2 April 2007 to acquire and convey the company's own shares. The Board of Directors decided at its meeting on 6 August 2007 to exercise its right to a total amount of 350,000 Class B shares of the company. So far, these shares have not been purchased. The Board does not have an existing authorisation to raise the share capital or to issue a bond loan, convertible loan or stock options.
    Ownership base
    At the end of September 2007, Orion had altogether 36,483 shareholders, of which 94.4% were private shareholders. Their holdings accounted for about 46.1% of the total number of shares and 57.9% of the total amount of votes. The number of nominee-registered shares was 38.8 million, representing 27.4% of the total number of shares and 5.5% of the total number of votes. The Company does not have treasury shares in its possession.
    No transactions exceeding the flagging limits set in the Finnish Securities Market Act have been brought to the attention of the company.
    Legal proceedings
    Orion Corporation has on 13 September 2007 filed a patent infringement lawsuit in the United States to enforce U.S. Patent No. 5,446,194 and U.S. Patent No. 5,135,950 against generic drug companies Wockhardt USA, Inc. and Wockhardt Limited, who seek to market generic entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's Disease by its exclusive licensee, Novartis.
    Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan. By virtue of the legal proceedings, the realisation of generic competition regarding Comtan is neither certain nor imminent.
    Events after the review period
    In early October, Orion Corporation was informed that an Abbreviated New Drug Application (ANDA) has been filed with the U.S. Food and Drug Administration (FDA) by a generic drug company seeking authorisation to produce and market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's Disease.
    The ANDA review process is just beginning and the realisation of generic competition regarding Stalevo is neither certain nor imminent. Orion is, together with Novartis, currently evaluating its legal options to protect its intellectual property rights.
    Review of the segments
    Pharmaceuticals business
    Market review
    The most important single market for Orion is Finland. According to the statistics collected by Finnish Pharmaceutical Data Ltd, the Finnish wholesales of pharmaceuticals in the first three quarters of 2007 rose by 5.2% to EUR 1 338 (1 272) million. Self-care medicine sales grew by 11.8% from those of the comparative period and hospital sales grew by 9.5%.
    Orion is strongly positioned as the leading marketer of pharmaceuticals in Finland. In the first three quarters of 2007, the wholesales of Orion's products totalled EUR 121.1 million, up by 7.9% from the comparative period. Orion's market share was 9.0% (8.8%), with which Orion was 1.4 percentage points ahead of the second-largest marketer.
    According to IMS Health pharmaceutical statistics in the 12-month period up to June 2007, the US wholesales of medicines for Parkinson's Disease, a core therapy area in Orion's business, were USD 1,131 (924) million, about 22% more than in the comparative 12-month period. The exceptionally rapid growth is mainly a result of the broadened indication of one dopamine agonist to encompass also the restless legs syndrome, in addition to Parkinson's Disease. In Europe, the five largest markets for Parkinson's Disease medicines are Germany, the UK, France, Spain and Italy. In these markets, the combined total sales of Parkinson's Disease medicines in the respective 12-month periods were EUR 772 (713) million, the average growth being about 8%.
    Net sales and profit of the Pharmaceuticals business
    The net sales of the Pharmaceuticals business in the first three quarters of 2007 were EUR 479.4 (449.1) million, up by 6.7% from the comparative period. Operating profit was EUR 156.9 (150.4) million, up by 4.3%. The EBIT margin of the Pharmaceuticals business was 32.7% (33.5%).
    Proprietary Products
    The combined net sales of Orion's proprietary products for Parkinson's Disease, i.e. Stalevo® (levodopa, entacapone, carbidopa) and Comtess®/Comtan® (entacapone) were EUR 152.6 (137.2) million, up by 11.3% from the comparative period and accounting for one-third of the total net sales of the Pharmaceuticals business, as in the comparative period. The net sales from shipments of Stalevo and Comtan to Novartis were EUR 91.9 (83.7) million, 9.8% more than in the comparative period. The net sales generated by Orion's own sales organisation from Stalevo and Comtess were EUR 60.7 (53.5) million, up by 13.6%. The strongest sales growth continued in the UK and Germany.
    A marketing authorisation for long-acting Enanton® (leuproreline acetate) was received in July for Finland and in September for Sweden. The products, Enanton Depot Dual 30 mg and Enanton Depot Set 30 mg, are used for the treatment of advanced prostate cancer. The new strength extends the treatment cycle from three months to six months. A marketing approval in Norway is expected by the end of 2007. Enanton, originated by Takeda Corporation, is marketed by Orion in the Nordic countries.
    Specialty Products
    The Specialty Products business generated net sales of EUR 178.4 (163.4) million in 1-9/2007, up by 9.1% from the comparative period.
    The net sales from the Easyhaler® franchise of asthma medicines were EUR 12.1 million, almost at the level of the comparative period. The sales of Easyhaler have picked up during the third quarter of 2007. This is mainly a result of the product launches in new markets areas, like Turkey, where a marketing agreement was signed with Abdi Ibrahim Pharmaceuticals, a Turkish pharmaceutical company, in the summer 2007.
    The business of Specialty Products has expanded well in the eastern European countries. The increase of Orion's sales has been above average in several markets in the region, including Russia.
    Sales in Finland have also continued at a good level during the year.
    Animal Health
    The net sales of the Animal Health business were EUR 51.4 (47.9) million and they grew by 7.3% from the comparative period, thanks to the continued favourable development of the sales by both Orion's own Scandinavian marketing organisation and the partners. The net sales of animal sedatives, Domitor® (medetomidine), Domosedan® (detomidine) and Antisedan® (atipamezole), continued to grow, now by 8.2%. These products accounted for about 42% (42%) of the total net sales of the Animal Health business.
    Fermion, which manufactures active pharmaceutical ingredients, generated EUR 26.7 (28.6) million in net sales, down by 6.6% from the comparative period. The impact of intra-Group transactions, i.e. supply to Orion's own operations, has been eliminated from the figures. The sales of the business division were especially affected by the weakened US dollar. On the other hand, Fermion's deliveries to Orion's internal use have increased significantly from the comparative period.
    10 best-selling pharmaceutical brands
    The net sales from Orion's ten best-selling pharmaceutical brands increased by 7.2% and they accounted for about 51% (51%) of the total net sales of the Pharmaceuticals business. The purchases by pharmacies of Burana® (ibuprofen) have returned to the long-term average levels since the downswing experienced in the previous year due to a change in the Finnish pharmaceuticals act.
    Proprietary products franchise
    The net sales from the proprietary products franchise were EUR 220.0 (206.6) million, up by 6.5% from the comparative period and accounting for 46% (46%) of the total net sales of the Pharmaceuticals business. Stalevo and the animal sedatives were the products showing growth.
    Pharmaceutical research and development
    Pharmaceutical research and development expenses were EUR 66.4 (56.9) million, representing 13.9% (12.7%) of the net sales of the Pharmaceuticals business. In accordance with its strategy, Orion aims to allocate its R&D resources in such a way that the best possible support is given to both the proprietary and generic prescription drugs businesses.
    STRIDE-PD study investigates if Stalevo medication can delay Parkinson's patients' onset of motor complications, i.e. dyskinesias, compared with conventional levodopa/carbidopa medication. The study has been on-going since late 2004, and it is being carried out in collaboration with Novartis in 14 countries. The study involves 747 patients, each being treated for almost three years. The results from the research programme are expected at the turn of 2008-2009.
    The clinical Phase 3 studies have started in May with dexmedetomidine (Precedex®) in patients in intensive care as an infusion administered for over 24 hours. The objective of the programme is to have the product registered in the EU. The product is already available e.g. in the USA and Japan as a sedative for patients in intensive care, administrable for up to 24 hours. The current Phase 3 programme consists of two studies, in which dexmedetomidine is compared with midazolam and propofol. Both arms are planned to involve 500 patients and they are estimated to be completed in about two years.
    A research programme is under way in clinical Phase 1 for the development of a new, more efficient COMT inhibitor than entacapone.
    The LEVET programme, which is studying the efficacy of levosimendan in the treatment of heart diseases in dogs, is progressing to the last research phase with an aim to receive marketing authorisations. Recruitment started in August 2007 both in the European and the US arms of the programme.
    In early research phases, Orion is investigating molecules affecting alpha 2 receptors in the central nervous system, and selective androgen receptor modulators (SARM), among others.
    Diagnostics business
    The net sales generated by Orion Diagnostica during the first three quarters of 2007 were EUR 31.5 (31.1) million. The sales of QuikRead® tests continued to show positive performance. These tests are used for the detection of infections on the basis of the CRP content in a blood sample. The sales of Uricult®, a test for the detection of urinary tract infections, as well as Hygicult® and Easicult®, tests for industrial hygiene, developed favourably during the period as well. The declined sales of certain old products slowed down the business division's net sales development. Additionally, the sales were affected by the restrictions in international trade with Iran.
    Steady growth continued in the sales by the division's own sales organisation covering the Nordic countries. In the export markets, the best growth was achieved in China, Czech, Spain and Slovakia.
    Operating profit was EUR 6.4 (6.0) million, up by 6.8% from the comparative period. EBIT was 20.2% (19.2%). The focus of the sales efforts continued to be on the most profitable products. In addition to the development of sales, the EBIT of the third quarter was affected by non-recurring items and increased expenditure on selling and marketing.
    Espoo, 24 October 2007
    Board of Directors of Orion Corporation
    Orion Corporation
    Jukka Viinanen                                           Jari Karlson
    President and CEO                                     CFO
    Group Income statement

    * The figure has been calculated from the profit attributable to the parent company shareholders.

    Balance sheet

    Equity and liabilities:


    Consolidated statement of changes in equity


    Cash flow statement


    Changes in property, plant and equipment

    Commitments and contingencies


    Related party transactions


    Performance by segment
    Net sales by business segment

    Operating profit by business segment

    Net sales by annual quarters

    Operating profit by annual quarters

    Geographical breakdown of net sales by annual quarters


    Review of the segments
    Key figures

    Breakdown of pharmaceuticals net sales by business areas

    Net sales of Orion's 10 Best-selling medicinals

    Diagnostics business
    Key figures


    Information on Orion Corporation's shares on 30 September 2007

    Both share classes provide equal rights to the company assets and dividends.
    trading in Orion's A and b shares during 1 janury-30 September 2007

    PErformance per share


    Orion Group structure
    Orion Corporation was established on 1 July 2006 as one of the two new listed companies that resulted from the demerger of the former Orion. The parent company of the Orion Group, Orion Corporation consists of two businesses and five business divisions:
  •               Pharmaceuticals
  • o        Proprietary Products (patented prescription products)
    o        Specialty Products (off-patent, generic prescription products and self-medication products)
    o        Animal Health
    o        Fermion (active pharmaceutical ingredients)
  •               Diagnostics
  • o        Orion Diagnostica (diagnostic tests).
    Accounting principles
    This interim report has been prepared in accordance with the accounting policies set out in International Accounting Standard 34 on Interim Financial Reporting and in the Group's Financial Statement for 2006, with the exception of the following new IFRS-standards and IFRIC-interpretations as of 1 January 2007
  •          IFRS 7 Financial Instruments: Disclosures
  •          IAS 1 amendment to standard, Presentation of Financial Statements: Capital Disclosures
  •          IFRIC 9 Re-assessment of Embedded Derivatives
  •          IFRIC 10 Interim Financial Reporting and Impairment
  • These new standards, amendments to standards and interpretations do not have a substantial effect on the Group's interim report nor reported figures.
    The principles and calculation methods are available on the Group's homepage at
    The figures have not been audited. Those in the parentheses are for the comparative period of the previous year. The per-share ratios have been adjusted.
    The figures have been rounded. Therefore, the total sums of individual figures may differ from the total sums shown.

    Calculation of the key figures

    OMX Nordic Exchange Helsinki
    Respective media
    Orion Corporation
    Orionintie 1A
    02200 Espoo

    Orion is a European pharmaceutical and diagnostics company which emphasises the development of innovative medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets pharmaceuticals for humans and animals, active pharmaceutical ingredients as well as diagnostic tests. Orion's clientele consists mainly of healthcare service providers and professionals. The Group's net sales in 2006 (proforma) were EUR 641.1 million and in the end of 2006 there were 3 061 employees working for the Group. Orion's stocks are listed in OMX Nordic Exchange Helsinki. In 2007, Orion celebrates its 90-year-history.