Orion Group Interim Report January-June 2011
(Thomson Reuters ONE) -
ORION CORPORATION / INTERIM REPORT JANUARY-JUNE 2 August 2011at 12:00 p.m. EEST
Orion Group Interim Report January-June 2011
Orion's net sales for January-June 2011 totalled EUR 471 million (EUR 422
million for January-June 2010), up by 12% on the comparative period last year.
* Operating profit was EUR 158 (131) million.
* Profit before taxes was EUR 158 (130) million.
* Equity ratio was 61% (59%).
* ROCE before taxes was 59% (50%).
* ROE after taxes was 53% (47%).
* Basic earnings per share were EUR 0.83 (0.68).
* Cash flow per share before financial items was EUR 0.54 (0.48).
* Orion estimates that net sales will be slightly higher and operating profit
excluding non-recurring items higher in 2011 than in 2010.
ORION'S KEY FIGURES FOR THE REVIEW PERIOD
Q2/11 Q2/10 Change % Q1-Q2/11 Q1-Q2/10 Change % 2010
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Net sales, EUR million 227.0 207.4 +9.5% 471.2 421.9 +11.7% 849.9
International operations,
EUR million 167.3 153.7 +8.8% 352.3 311.2 +13.2% 620.7
% of net sales 73.7% 74.1% 74.8% 73.8% 73.0%
Operating profit, EUR
million 65.1 60.0 +8.5% 158.0 131.0 +20.6% 254.2
% of net sales 28.7% 28.9% 33.5% 31.1% 29.9%
Profit before taxes, EUR
million 64.8 59.4 +9.0% 157.5 130.2 +20.9% 252.6
% of net sales 28.5% 28.6% 33.4% 30.9% 29.7%
Income tax expense, EUR
million 16.8 15.4 +8.9% 41.0 33.9 +21.0% 67.9
R&D expenses, EUR million 22.9 20.2 +13.4% 42.7 39.4 +8.4% 85.5
% of net sales 10.1% 9.7% 9.1% 9.3% 10.1%
Capital expenditure, EUR
million 10.1 9.7 +3.4% 17.3 17.8 -2.7% 39.2
% of net sales 4.4% 4.7% 3.7% 4.2% 4.6%
Assets total, EUR million 668.5 655.5 +2.0% 745.8
Equity ratio, % 60.7% 58.7% 62.7%
Gearing, % 11.2% 12.6% -12.2%
Interest-bearing
liabilities, EUR million 105.7 127.0 -16.7% 110.0
Non-interest-bearing
liabilities, EUR million 157.3 146.0 +7.7% 168.4
Cash and money market
investments, EUR million 60.4 78.9 -23.5% 167.2
ROCE (before taxes), % 59.0% 49.5% 45.0%
ROE (after taxes), % 53.4% 46.9% 40.7%
Basic earnings per share,
EUR 0.34 0.31 +9.2% 0.83 0.68 +21.0% 1.31
Diluted earnings per
share, EUR 0.34 0.31 +9.2% 0.83 0.68 +21.0% 1.31
Cash flow per share
before financial items,
EUR 0.20 0.25 -23.3% 0.54 0.48 +13.2% 1.26
Equity per share, EUR 2.88 2.71 +6.2% 3.32
Personnel at the end of
the period 3,435 3,228 +6.4% 3,131
Average personnel during
the period 3,245 3,135 +3.5% 3,137
Personnel expenses, EUR
million 94.0 84.6 +11.2% 170.3
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President and CEO Timo Lappalainen's review
"Solid growth continued"
"Our net sales and operating profit in the first half of the year were higher
than a year ago.
"In Orion's key markets in Europe, the prices of drugs reimbursed under
healthcare systems continued to decline in many countries. Nevertheless, we
performed well in this very challenging operating environment. Sales of our
Parkinson's drugs continued to rise, mainly because deliveries to Novartis
increased. Sales from our other product ranges grew throughout the first half of
the year. We strengthened our market position in Finland and maintained our
growth in Scandinavia and Eastern Europe.
"As anticipated, sales drives increased sales and marketing expenses. Research
and development expenses also increased slightly because new clinical trials
commenced this year.
"In July we took a significant step forward for Orion's future when the
Committee for Medicinal Products for Human Use of the European Medicines Agency
issued a positive opinion recommending the granting of marketing authorisation
for dexdor(®)( )(dexmedetomidine), a new intensive care sedative.
"The key themes of our strategy remain the same following the review in June.
The strategic focus remains on growth of business operations through a
competitive product portfolio, strengthening the market position in Europe and
improving the flexibility and efficiency of operations. A prerequisite for
achieving these objectives is continuous enhancement of our capability to
network and collaborate with partners at all stages of the value chain. The
progress made in all these areas in the past couple of years is a good
foundation for continuing to implement our strategy in the future when sales of
our Parkinson's drugs start to decline due to generic competition.
"Our outlook estimate remains the same. We estimate that net sales will be
slightly higher and operating profit excluding non-recurring items higher than
in 2010. More information on the outlook forecast and the basis for it can be
found on pages 6-7 of this Interim Report."
Events during the period
On 13 April Orion upgraded its full-year outlook for 2011 because sales had
developed well in the first quarter.
Events after the period
On 22 July Orion announced that it had received information that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) had issued a positive opinion recommending the granting of marketing
authorisation for dexdor(®)( )(dexmedetomidine), a new intensive care sedative.
On 22 July Orion Diagnostica strengthened its research and product development
base by acquiring new early-phase technology through purchasing all the shares
of English technology company GeneForm Technologies Ltd.
News conference and teleconference
A news conference and teleconference on the published results will be held
today, Tuesday 2 August 2011, at 13:30 EEST in Hotel Kämp, address:
Pohjoisesplanadi 29, Helsinki. President and CEO Timo Lappalainen will give a
brief presentation in English on the financial review.
The event can be followed live as a webcast accessible via the Orion website at
www.orion.fi/en/. After the presentation, questions can be asked by telephone in
Finnish and English.
The teleconference code is 891284 and to participate in the teleconference,
please call:
from United States: +1 888 222 0364
from other countries: +44 (0)20 7162 0125
News conference recordings
A recording of the webcast of the event in English will be available later the
same day via a link on the Orion website. A recording of the presentation by the
President and CEO in Finnish will be available on the Orion website later on the
same day.
Financial report material
Financial reports and related presentation material are available at
www.orion.fi/en/ promptly after publication. The website also has a form for
subscribing to Orion's releases.
Dates in Orion Calendar 2011 and 2012
Interim Report January-September 2011 Tuesday 25 October 2011
Financial Statements 2011 Tuesday 7 February 2012
Annual General Meeting 2012 Tuesday 20 March 2012
Interim Report January-March 2012 Tuesday 24 April 2012
Capital Markets Day in Helsinki Thursday 24 May 2012
Interim Report January-June 2012 Tuesday 31 July 2012
Interim Report January-September 2012 Tuesday 23 October 2012
The Annual Report 2011 will be published on the company's website latest on week
10/2012.
For additional information about the financial review:
Jari Karlson, CFO, tel. +358 10 426 2883
www.orion.fi/en
www.orion.fi/en/investors/
Financial review Q1-Q2/2011
Net sales
The Orion Group's net sales in January-June 2011 totalled EUR 471 million (EUR
422 million in January-June 2010), up by 12% on the comparative period of the
previous year. Foreign exchange rates had no significant effect on net sales in
the review period.
The Pharmaceuticals business's net sales were up by 12% at EUR 447 (399)
million. The products based on in-house R&D accounted for EUR 217 (197) million,
or 49% (49%) of the Pharmaceuticals business's net sales. Net sales of Orion's
Stalevo(®) (carbidopa, entacapone and levodopa) and Comtess(®)/Comtan(®)
(entacapone) Parkinson's drugs were up by 14% at EUR 143 (126) million, which is
32% (31%) of the Pharmaceuticals business's net sales. The net sales of other
products in the portfolio (excluding Parkinson's drugs) were up by 11% at EUR
304 (274) million.
The Diagnostics business's net sales were up by 6% at EUR 25 (24) million.
Operating profit
The Orion Group's operating profit was up by 21% at EUR 158 (131) million.
The Pharmaceuticals business's operating profit was EUR 159 (131) million, up by
22% on the comparative period. The gross profit grew faster than net sales due
especially to an increase in royalties and milestone payments. The fixed costs
of the business operations were as anticipated higher than in the comparative
period.
The Diagnostics business's operating profit was at EUR 3.4 (4.1) million, down
by 17% on the comparative period. Despite the increase in net sales, the gross
profit was only similar to the comparative period and fixed costs were higher.
Operating expenses
The Group's sales and marketing expenses were higher, as anticipated, at EUR
107 (89) million. Costs were increased by additional expenditure for enhancing
the sales operations especially in Scandinavia and Eastern Europe. Expenses
include also write downs of the value of product rights in intangible assets.
R&D expenses were up by 8% at EUR 43 (39) million and accounted for 9% (9%) of
the Group's net sales. Pharmaceutical R&D expenses amounted to EUR 40 (37)
million. Research projects are reported in more detail under Pharmaceuticals in
the Business Reviews.
Administrative expenses were EUR 20 (20) million.
Other operating income and expenses increased profit by EUR 3 million (profit
decrease in comparative period EUR 5 million). They comprise items arising
mainly from foreign exchange hedges.
Profit before taxes
Group profit before taxes totalled EUR 158 (130) million. Basic earnings per
share were EUR 0.83 (0.68) and diluted earnings per share were EUR 0.83 (0.68).
Equity per share was EUR 2.88 (2.71). The return on capital employed before
taxes (ROCE) was 59% (50%) and the return on equity after taxes (ROE) 53% (47%).
Financial position
The Group's gearing was 11% (13%) and the equity ratio 61% (59%).
Total liabilities at 30 June 2011 were EUR 263 (273) million. At the end of the
period, interest-bearing liabilities amounted to EUR 106 (127) million,
including EUR 83 (104) million of long-term loans.
The Group had EUR 60 (79) million of cash and cash equivalents at the end of the
period, which are invested in short-term interest-bearing instruments issued by
financially solid financial institutions and corporations.
Cash flow
Cash flow from operating activities was higher than in the comparative period at
EUR 92 (84) million. Operating profit was clearly higher in the first half of
2011, but the amount tied up into working capital was more than in the
comparative period at EUR 50 (44) million. The increase in working capital was
due to growth in net sales, which led to the increase in trade receivables and
stocks.
Cash flow from investing activities was EUR -16 (-17) million. Cash flow from
financing activities was EUR -182 (-160) million. This change was due to the
higher dividend than in the previous year.
Capital expenditure
The Group's capital expenditure totalled EUR 17 (18) million. This comprised EUR
11 (11) million on property, plant and equipment and EUR 7 (7) million on
intangible assets.
Outlook for 2011
Net sales will be slightly higher than in 2010.
Marketing expenditure will be higher due to the increased number of product
launches. Research expenditure will be higher than in 2010.
Operating profit excluding non-recurring items will be higher than in 2010.
The Group's capital expenditure will be about EUR 45 million excluding
substantial corporate or product acquisitions.
Basis for outlook
Price competition in the Finnish market will persist in 2011. However, product
launches will continue to support Orion's position as market leader.
In-market sales of the Parkinson's drugs grew by just under 10% in 2010. The
pace of growth of sales is forecast to continue to slow in 2011. Deliveries to
Novartis have typically been greatest in the first half of the year and least in
the last quarter of the year. The generic competition commencing in April 2012
in the United States is not expected to have a material impact on Orion's sales
in 2011.
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 2011
were planned mainly during the previous year.
Research and development costs can be estimated quite accurately in advance.
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 2011 are either ongoing from the
previous year or at an advanced stage of planning, therefore their cost level
can be estimated rather accurately.
The estimated costs of the ongoing patent litigation in the United States are
based on the planned timetables and work estimates. The costs due to the
litigation will depend on a number of factors, which are difficult to estimate
accurately.
Near-term risks and uncertainties relating to the outlook
The Company is not aware of any significant risk factors relating to the
earnings outlook for 2011.
Sales of individual products and also Orion's sales in individual markets may
vary slightly depending on the extent to which the ever-tougher price and other
competition prevailing in pharmaceutical markets in recent years will
specifically affect Orion's products. Deliveries to Novartis are based on
timetables that are jointly agreed in advance. Nevertheless, they can change,
for example as a consequence of decisions by Novartis concerning adjustments of
stock levels.
Most of the exchange rate risk relates to the US dollar. Typically, only less
than 15% of Orion's net sales come from the United States. As regards currencies
in European countries, the overall effect 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.
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.
Financial objectives
Orion's financial objectives are ensuring the Group's financial stability and
creating a foundation for long-term profitable growth.
The principal means of achieving these objectives are:
* improving the organic development of net sales and operating profit through
product, product portfolio and corporate acquisitions
* increasing the efficiency of operations and cost control
* maintaining a stable financial position, with the equity ratio at least 50%
Sales of Stalevo(®) and Comtess(®)/Comtan(®) currently account for approximately
one-third of Orion's net sales. The key patents for these Parkinson's drugs in
Orion's main markets will expire in 2012-2013, which is why their sales are
expected to decline over the next few years. Orion is continuously bringing new
products to the market to replace this drop in net sales.
The development of Orion's net sales and profitability in the next few years
will depend on how fast the sales of Parkinson's drugs will decline and, on the
other hand, how the sales of other products will increase in the future. This
creates a point of discontinuity in the Group's operations.
Strategy
In June, Orion's Board of Directors confirmed that the strategic focus remains
the same for 2012-2016. Orion's strategic aims are profitable growth and
increased shareholder value, whilst keeping business risks under control.
Orion's strategic focus continues to be on:
* growth of business operations through a competitive product portfolio
* strengthening market position in Europe
* improving the flexibility and efficiency of operations
All of Orion's business divisions have a major role in achieving the financial
objectives of the Group, but the two largest divisions, Proprietary Products and
Specialty Products, are crucial. Orion strives to enhance synergies between
patent-protected proprietary drugs, off-patent (i.e. generic) prescription drugs
and self-care products.
Competitive product portfolio
Growth is based on a competitive product portfolio developed through Orion's in-
house R&D, collaborative research and active product acquisition. Potential
corporate acquisitions are also continually evaluated.
Orion's core therapy areas are central nervous system drugs, oncology and
critical care drugs, and inhalable Easyhaler(®) pulmonary drugs. Orion's R&D
operations concentrate on early-phase research. In addition to in-house
research, Orion invests in early-phase R&D jointly with universities and other
pharmaceutical companies. In the late phase of clinical development, Orion aims
to share the costs with other pharmaceutical companies. Orion generally seeks
partnerships for undertaking at least Phase III clinical trials, which are the
final phase, especially for projects outside Europe. Orion also seeks to
purchase new product candidates and further developed products to reinforce the
research pipeline based on its own research projects.
In recent years Orion has worked to build up a competitive product portfolio. As
regards Proprietary Products customers, the focus is on neurologists,
urologists, pulmonary doctors, critical care doctors and other health care
professionals in these specialised fields. For Specialty Products, important
customer groups in Finland, for example, are general practitioners and pharmacy
staff. Orion's primary aim is to exploit all business opportunities from the
drugs in the current product portfolio, such as Stalevo(®), Simdax(®) and the
Easyhaler product family. Orion's next projects in late-phase development and
commercialisation are launching the intensive care sedative dexmedetomidine in
European markets, development of inhalable Easyhaler combined formulation
products and development of the Parkinson's drug Stalevo for Japanese markets.
Orion also aims to ensure continuity of clinical trials through active early-
phase research.
To be successful in the generic (i.e. off-patent) prescription drug and self-
care product sector, it is especially important to have a broad and continually
renewed portfolio. Orion seeks to secure a continuous stream of product launches
through active product acquisition and its own development work. Orion
determines the product portfolios individually for each market. The Company
continues to strive for growth, especially through expanding the self-care
product portfolio in the Nordic countries. In Eastern Europe, for example
Russia, Orion's product portfolio focuses on generic prescription drugs in
certain therapy areas.
Strengthening market position in Europe
In the current year Orion continued to strengthen its market position and sales
network in the key European markets.
In specialised medical care, especially critical care and urology, Orion
concentrates on certain customer groups through its own sales network throughout
Europe and through partners worldwide. Orion markets generic prescription drugs
and self-care products mainly in the Nordic countries and Eastern Europe through
its own sales network. Orion aims to strengthen its market leadership in Finland
and make the Scandinavian countries a domestic market in which it has a strong
presence. Orion's aim in all the Nordic countries is to have a presence with a
broad product range. In Central and Southern Europe the emphasis is on
proprietary products and in Eastern Europe on generic products. Outside Europe,
Orion operates mainly with partners.
Flexible and efficient operations
Because the operating environment changes all the time, the agility and
flexibility of operations will in future be as crucial as cost-effectiveness.
Efficiency improvement, cost control and complexity management are all essential
for systematic improvement of competitiveness throughout the value chain.
Orion's key projects to improve operating efficiency have been implementing a
new research and development model, building up partnership models for early-
phase research, increasing efficiency in the supply chain and improving the
competitiveness of sales operations.
Networking and seeking partners throughout the value chain will facilitate
improvements to competitiveness and establishing a foundation for profitable
future growth. R&D collaboration and active networking will enable Orion to
increase the number of new research projects and balance the risks of projects
in the research pipeline. Through partnerships in the supply chain, Orion will
improve the efficiency of its operations by determining which products it will
manufacture itself and to what extent products or semi-finished products will be
acquired through its collaboration network. Partnerships in sales and marketing
will ensure a broad network of distribution channels through which proprietary
drugs developed by Orion will be distributed worldwide. Moreover, the product
portfolio can be expanded by selling the partners' products through Orion's own
sales network.
Through these strategic actions, Orion seeks to enhance its capability to
continue operating as a pharmaceuticals and diagnostics company that provides
new products and engages in R&D.
Dividend 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 2011 Orion had a total of 141,257,828 (141,257,828) shares, of which
46,183,877 (48,320,530) were A shares and 95,073,951 (92,937,298) B shares. The
Group's share capital was EUR 92,238,541.46 (92,238,541.46). At the end of June
2011 Orion held 413,754 (214,424) B shares as treasury shares. On 30 June 2011
the aggregate number of votes conferred by the A and B shares was 1,018,337,737
(1,059,133,474) excluding treasury shares.
At the end of June 2011, Orion had 56,655 (56,615) 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 the General Meetings of Shareholders. In addition, Orion and
Orion Pension Fund do not have the right to vote at Orion Corporation's General
Meetings 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. In January-June 2011 a total of 1,379,688 shares were converted.
Trading in Orion's shares
Orion's A shares and B shares are quoted on NASDAQ OMX 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 2011 the market capitalisation of the Company's shares excluding
treasury shares was EUR 2,504 million.
Authorisations of the Board of Directors
Orion's Board of Directors was authorised by the Annual General Meeting on 24
March 2010 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 is valid for 18 months and the authorisation to issue shares for
five years from the respective decision taken by the Annual General Meeting.
On 18 May 2010 the Board of Directors of Orion Corporation decided to repurchase
shares as authorised by the Annual General Meeting. Orion acquired in total
300,000 B shares of Orion Corporation on 11-18 August 2010 in accordance with
the decision. The shares were acquired for use as part of the long-term
incentive plan for the Orion Group's key persons. Following this acquisition,
the Board of Directors is not authorised to repurchase any more of the Company's
own shares. The terms for repurchasing the Company's own shares under the
authorisation were published in a stock exchange release on 24 March 2010.
The Board of Directors is authorised to decide on conveyance of no more than
500,000 Orion Corporation B shares held by the Company. Such shares held by the
Company can be conveyed either against or without payment. Such shares held by
the Company can be conveyed by selling them in public trading on NASDAQ OMX
Helsinki; in a share issue placement to the Company's shareholders in proportion
to their holdings at the time of the conveyance regardless of whether they own A
or B shares; or in a share issue placement deviating from shareholders' pre-
emptive rights if there is a weighty financial reason, such as the development
of the capital structure of the Company, using the shares to finance possible
corporate acquisitions or other business arrangements of the Company, financing
capital expenditure or as part of the Company's incentive plan. The share issue
placement can be without payment only if there is an especially weighty
financial reason in the view of the Company and to the benefit of all its
shareholders. The amounts paid for shares in the Company conveyed shall be
recorded in a distributable equity fund. The Board of Directors shall decide on
other matters related to the conveyance of shares held by the Company. The
authorisation was exercised as described below under the heading "Share-based
Incentive Plan". On 30 June 2011 the Board of Directors had remaining
authorisation to decide on conveyance of 397,100 Orion Corporation B shares held
by the Company.
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 Plan
In February 2010 the Board of Directors of Orion Corporation decided on a new
share-based incentive plan for the Group key persons. The Plan includes earning
periods and the Board of Directors will annually decide on the beginning and
duration of the earning periods in 2010, 2011 and 2012. The Board of Directors
will decide on the earnings criteria and on targets to be established for them
at the beginning of each earning period. The target group of the Plan consists
of approximately 30 people. The total maximum amount of rewards to be paid on
the basis of the Plan is 500,000 Orion Corporation B shares and a cash payment
corresponding to the value of the shares.
On 1 March 2011 Orion transferred altogether 102,900 Orion Corporation B shares
held by the Company as a share bonus for 2010 to the key persons employed by the
Group and belonging to the Share-based Incentive Plan of the Group. The transfer
was based on the authorisation by the Annual General Meeting on 24 March 2010.
Share ownership
At the end of June 2011 Orion had a total of 56,655 (56,615) registered
shareholders, of whom 94% (95%) were private individuals holding 50% (52%) of
the entire share stock and 64% (64%) of the total votes. There were altogether
43 (37) million nominee-registered shares which is 31% (26%) of all shares, and
they conferred entitlement to 6% (5%) of the votes.
At the end of June 2011 Orion held 413,754 (214,424) B shares as treasury
shares, which is 0.3% (0.2%) of the Company's total share stock and 0.04%
(0.02%) of the total votes.
No new transactions exceeding the notification threshold set in the Finnish
Securities Markets Act were brought to the attention of the Company during the
review period.
Personnel
The average number of employees in the Orion Group in January-June 2011 was
3,245 (3,135). At the end of June 2011 the Group had a total of 3,435 (3,228)
employees, of whom 2,729 (2,599) worked in Finland and 706 (629) outside
Finland.
Salaries and other personnel expenses in January-June 2011 totalled EUR 94 (85)
million.
Significant legal proceedings
Legal proceedings against the Sandoz companies
On 4 September 2009 Orion Corporation and Hospira, Inc. filed together a patent
infringement lawsuit in the United States against Sandoz International GmbH and
Sandoz Inc. to enforce their patents valid in the United States. Sandoz Canada
Inc. has since been added as a defendant in the lawsuit. The legal proceedings
concern Orion's US Patent No. 4,910,214 and Orion's and Hospira's commonly owned
US Patent No. 6,716,867.
Sandoz Inc. has sought authorisation to produce and market in the United States
a generic version of Orion's proprietary drug Precedex(®) (dexmedetomidine
hydrochloride 100 mcg/ml), which is marketed in the United States by Orion's
licensee Hospira.
Orion expects the costs of the legal proceedings against the Sandoz companies to
be substantially less than the costs of the entacapone patent litigation that
had previously been pending in the United States.
Legal proceedings against Caraco Pharmaceutical Laboratories, Ltd.
On 12 November 2010 Orion Corporation and Hospira, Inc. jointly filed a patent
infringement lawsuit in the United States against Caraco Pharmaceutical
Laboratories, Ltd. to enforce Orion's and Hospira's joint patent No. 6,716,867
valid in the United States.
Caraco had submitted an application for authorisation to produce and market in
the United States a generic version of Orion's proprietary drug Precedex(®)
(dexmedetomidine hydrochloride 100 mcg/ml), which is marketed in the United
States by Orion's licensee Hospira.
Orion expects the costs of the legal proceedings against Caraco to be
substantially less than the costs of the entacapone patent litigation that had
previously been pending in the United States. According to the schedule
confirmed by the court, the main hearing of the case will commence on 13
November 2012.
Legal proceedings against Mylan Pharmaceuticals Inc.
On 24 January 2011 Orion Corporation filed a patent infringement lawsuit in the
United States against Mylan Pharmaceuticals Inc. to enforce its US patent No.
5,446,194.
Mylan intends to market in the United States a generic version of entacapone
tablets with strength 200 mg like Orion's Comtan(®) proprietary drug. Comtan is
used as an adjunct to levodopa/carbidopa therapy to treat patients with
idiopathic Parkinson's disease who experience the signs and symptoms of end-of-
dose "wearing-off." Novartis is Orion's exclusive licensee for marketing the
drug Comtan in the United States.
Business Reviews
Pharmaceuticals
Review of human pharmaceuticals market
According to statistics collected by Finnish Pharmaceutical Data Ltd, Finnish
wholesale of human pharmaceuticals in January-June 2011 totalled EUR 967 (937)
million, up by 3% on the comparative period of the previous year.
Finland is the most important individual market for Orion, generating about one-
quarter of the total net sales. Orion was able to increase its sales faster than
the markets as a whole, so strengthened its position as leader in marketing
pharmaceuticals in Finland. According to statistics collected by Finnish
Pharmaceutical Data Ltd, Orion's wholesale of human pharmaceuticals in Finland
in January-June amounted to EUR 100 (92) million, up by 8% compared with the
corresponding period in the previous year. Orion's market share was 10% (10%),
which was over four percentage points higher than the second-largest company's
market share.
According to IMS Health pharmaceutical sales statistics, in the 12-month period
ending in March 2011 the total sales of Parkinson's drugs in the United States
were down by 18% at USD 836 million (USD 1,022 million in the previous 12-month
period). The decline of in-market sales was due to start of generic competition
of some products. The five largest European markets for Parkinson's disease
drugs were Germany, the United Kingdom, France, Spain and Italy. In these
countries, the combined sales of Parkinson's drugs in the 12-month period ending
in March 2011 totalled EUR 1,035 (962) million, and the average market growth
was 8%.
The most important individual therapy area for Orion is still the treatment of
Parkinson's disease. Orion's Parkinson's drugs account for just under one-third
of the Group's net sales. Sales of Orion's Parkinson's drugs continued to grow
well and clearly better than the market as a whole in the United States and in
Japan. According to IMS Health pharmaceutical sales statistics, in the 12-month
period ending March 2011, sales of Orion's Parkinson's drugs were up by 1% at
USD 180 (178) million in the United States, up by 4% at a total of EUR 158 (152)
million in the five largest markets in Europe, and up by 43% at EUR 50 (35)
million in Japan. The market share of Orion's Parkinson's drugs was 22% in the
United States, on average 15% in the five largest European markets and 10% in
Japan.
According to IMS Health pharmaceutical sales statistics, sales of Orion's
Precedex(®) intensive care sedative (dexmedetomidine) were up by 51% at USD 175
million in the 12-month period ending March 2011 (USD 116 million in the
previous 12-month period). About four-fifths of the sales amounting to USD 141
(99) million were in the United States, where Precedex sales grew by 42%.
Net sales and operating profit of the Pharmaceuticals business
Net sales of the Pharmaceuticals business in January-June 2011 were EUR 447
(399) million, up by 12% on the comparative period of the previous year. The
operating profit of the Pharmaceuticals business was up by 22% at EUR 159 (131)
million. The operating profit of the Pharmaceuticals business was 36% (33%) of
the segment's net sales.
Net sales of Orion's top ten pharmaceuticals in January-June 2011 were up by
11% at EUR 243 (218) million. They accounted for 54% (55%) of the total net
sales of the Pharmaceuticals business. The drug Solomet(®) (methylprednisolone)
for treatment of inflammatory diseases entered the list of the top ten best-
selling pharmaceutical products, replacing Fareston(®) which is used for
treatment of breast cancer.
Net sales of the products based on own in-house R&D were up by 10% at EUR 217
(197) million in January-June 2011. These products accounted for about 49% (49%)
of the 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 Proprietary Products in January-June 2011 were up by 16% at EUR
214 (184) million.
Orion's drugs for treatment of Parkinson's disease are Stalevo(®) (active
ingredients carbidopa, levodopa and entacapone) and Comtess(®)/Comtan(®)
(entacapone), and their net sales in January-June 2011 totalled EUR 143 (126)
million. The net sales of Parkinson's drugs were up by 14% and accounted for
32% (31%) of the total net sales of the Pharmaceuticals business. Net sales from
deliveries of Stalevo and Comtan to Novartis were up by 23% at a total of EUR
95 (77) million. Deliveries of Stalevo to Novartis increased by 18%, and
deliveries of Comtan by 32%. Total net sales generated by Stalevo and Comtess in
Orion's own sales organisation totalled EUR 48 (49) million. Sales through
Orion's own sales organisation totalled EUR 40 (40) million for Stalevo and EUR
8 (9) million for Comtess.
The US Food and Drug Administration (FDA) has an ongoing safety review of
Stalevo, which began in spring 2009. Orion is assisting the FDA in undertaking
the safety review. The FDA has requested additional data based on databases
concerning the significance of the results of the STRIDE-PD study, and
consequently Orion and Novartis have decided to undertake two epidemiological
studies, which must be completed by July 2012.
Net sales of Simdax(®), a drug for acute decompensated heart failure, were up by
5% at EUR 21 (20) million in January-June 2011.
Net sales of the Easyhaler(®) product family for treatment of asthma and chronic
obstructive pulmonary disease were up by 15% in January-June 2011 at EUR 17 (15)
million. Sales of Easyhaler products through Orion's own sales organisation in
Europe continued to grow strongly in the first half of the year.
Net sales of the Precedex(®) intensive care sedative (active ingredient
dexmedetomidine) were up by 12% in January-June 2011 at EUR 14 (13) million. In-
market sales continued to grow well in all markets. In the United States and
markets outside Europe the sedative is sold by Orion's partner Hospira. US
markets account for about four-fifths of net sales of Precedex.
Specialty Products
Net sales of the Specialty Products business division's off-patent, i.e.
generic, prescription drugs and self-care products in January-June 2011 were up
by 10% at EUR 158 (144) million. Net sales of the business division in markets
outside Finland were up by 13% compared with the corresponding period in the
previous year. Growth was especially strong in Scandinavia, which Orion aims to
make its domestic market. Sales also grew in Russia. The number of generic
prescription drug and self-care product launches remained high in the first half
of the year.
Net sales of Orion's human pharmaceuticals in Finland were up by 8% at EUR 109
(101) million in January-June 2011. Specialty Products accounted for the
majority of sales in Finland. In Finland sales growth was especially strong in
the second quarter. Orion has a broad product portfolio, particularly in
substitutable prescription drugs, and a competitive self-care product portfolio
in Finland.
Net sales of Orion's human pharmaceuticals in Eastern Europe in January-June
2011 were up by 18% at EUR 25 (22) million. Specialty Products account for the
majority of sales in the region. The strong growth in net sales is the result of
prolonged work to strengthen the market position through a competitive product
portfolio.
In June the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) issued a positive opinion recommending the
granting of marketing authorisation for Orion's new entacapone and
levodopa/carbidopa/entacapone products. They are generic versions of Orion's own
Parkinson's drugs Comtess(®) (entacapone) and Stalevo(®)
(levodopa/carbidopa/entacapone).
Animal Health
Net sales of the Animal Health business division in January-June 2011 were up by
5% at EUR 34 (33) million. Net sales of the animal sedatives at EUR 11 million
accounted for 32% (33%) of the division's net sales. Orion's animal sedatives
are Dexdomitor(®) (dexmedetomidine), Domitor(®) (medetomidine), Domosedan(®)
(detomidine) and Antisedan(®) (atipamezole).
Deliveries that commenced in the second quarter of this year following product
launches and new distribution agreements in the first quarter strengthened
Orion's position in the Nordic veterinary drug market, where Orion is one of the
three largest marketers of veterinary drugs.
According to statistics collected by Pharma Industry Finland, the Finnish market
for veterinary drugs was up by 3% at about EUR 26 (25) million in January-June
2011. Orion was the second-largest marketer, with a market share of 20% (19%).
Orion was the only one of the five largest veterinary drug companies that
increased its market share significantly compared with the corresponding period
last year.
Fermion
Fermion manufactures active pharmaceutical ingredients for Orion and other
pharmaceutical companies. Its product range comprises nearly 30 pharmaceutical
ingredients. Fermion's net sales in January-June 2011 excluding pharmaceutical
ingredients supplied for Orion's own use were EUR 25 (26) million and accounted
for about two-thirds of Fermion's entire net sales. Several key products
performed well, even though competition in the markets remained intense.
Research and development projects
The Group's R&D expenses in January-June 2011 totalled EUR 43 (39) million, of
which the Pharmaceuticals business accounted for EUR 40 (37) million. The
Group's R&D expenses accounted for 9% (9%) of the Group's net sales. R&D
expenses also include expenses relating to development of the current portfolio.
Processing of the marketing authorisation application for Orion's intensive care
sedative dexmedetomidine by the European Medicines Agency is continuing. After
the review period, in July Orion received information that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
had issued a positive opinion recommending the granting of marketing
authorisation for the new intensive care sedative dexdor(®). The brand name for
dexmedetomidine in Europe is dexdor(®). The European Commission is expected to
make the final decision on granting the marketing authorisation in the coming
months.
Orion has ongoing projects to broaden the range of the inhalable Easyhaler(®)
drugs product family. Orion is developing a budesonide-formoterol formulation
that combines budesonide as an anti-inflammatory agent and formoterol as a long-
acting bronchodilator. Results from bioequivalence studies are anticipated in
early 2012. In addition, Orion has another Easyhaler research programme in
progress to develop a fluticasone-salmeterol formulation. In this formulation
fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-
acting bronchodilator.
Orion is collaborating with Novartis to develop Stalevo(®) drug for the Japanese
market. The timeline for regulatory submission is under evaluation by Novartis.
Orion is continuing to develop an androgen receptor antagonist for the treatment
of advanced prostate cancer jointly with Endo Pharmaceuticals Inc. with the
objective of approval of the drug globally. Clinical trials commenced in the
first quarter of the current year in Europe.
Orion has Phase II clinical trials with the alpha 2(c) receptor antagonist in
progress. The trials are investigating the efficacy and safety of the drug
candidate in treating Alzheimer's disease and Raynaud's phenomenon.
Orion is developing a new more effective levodopa product based on optimised new
formulations and doses of known compounds. Product development is in the
clinical trials phase.
In addition, Orion has several projects in the early research phase
investigating prostate cancer, neuropathic pain, Parkinson's disease and
Alzheimer's disease, among others.
In May the US pharmaceutical company GTx announced that it had ended studies on
the use of 80 mg doses of toremifene for treating the adverse effects of
prostate cancer treatment. Orion originally developed toremifene for treatment
of breast cancer.
Diagnostics
Orion Diagnostica manufactures convenient and quick in vitro diagnostic tests
and testing systems suitable for point-of-care testing. Net sales of the
Diagnostics business in January-June 2011 were up by 6% at EUR 25 (24) million.
Sales of QuikRead(®) infection tests remained strong in the review period. Sales
of collagen tests that measure bone and connective tissue metabolism also
developed well. Progress in the Nordic countries was stronger than in the
comparative period, and sales continued to grow in China and the Czech Republic,
for example.
Launching of the new more user-friendly prefilled QuikRead 101 system and
QuikRead go(®), a new generation testing instrument, has progressed as planned,
and in the case of QuikRead go is moving into the next geographical phase.
After the review period, in July Orion Diagnostica strengthened its research and
product development base by acquiring new early-phase technology through
purchasing all the shares of English technology company GeneForm Technologies
Ltd.
The operating profit of the Diagnostics business was down 17% at EUR 3.4 (4.1)
million and accounted for 14% (17%) of the segment's net sales. The profit in
the second quarter decreased because fixed costs increased and the margin
structure of the product sales portfolio was weaker than in the comparative
period.
Espoo, 2 August 2011
Board of Directors of Orion Corporation
Orion Corporation
Timo Lappalainen Jari Karlson
President and CEO CFO
Tables
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
EUR million Q2/11 Q2/10 Change % Q1-Q2/11 Q1-Q2/10 Change % 2010
--------------------------------------------------------------------------------
Net sales 227.0 207.4 +9.5% 471.2 421.9 +11.7% 849.9
Cost of goods sold -74.8 -68.2 +9.7% -147.5 -137.8 +7.0% -283.2
-------------------------------------- ------------------- -------
Gross profit 152.3 139.2 +9.3% 323.7 284.0 +14.0% 566.8
-------------------------------------- ------------------- -------
Other operating income
and expenses 1.0 -2.2 +143.2% 3.0 -4.6 +165.4% 1.2
Selling and marketing
expenses -54.4 -44.8 +21.6% -106.6 -88.7 +20.1% -188.9
R&D expenses -22.9 -20.2 +13.4% -42.7 -39.4 +8.4% -85.5
Administrative expenses -10.8 -12.1 -10.7% -19.5 -20.3 -3.8% -39.3
------------- ------------------- -------
Operating profit 65.1 60.0 +8.5% 158.0 131.0 +20.6% 254.2
-------------------------------------- ------------------- -------
Finance income 1.3 1.7 -23.9% 2.6 2.7 -2.7% 4.2
Finance expenses -1.6 -2.2 -29.1% -3.1 -3.4 -9.8% -5.9
-------------------------------------- ------------------- -------
Profit before taxes 64.8 59.4 +9.0% 157.5 130.2 +20.9% 252.6
-------------------------------------- ------------------- -------
Income tax expense -16.8 -15.4 +8.9% -41.0 -33.9 +21.0% -67.9
-------------------------------------- ------------------- -------
Profit for the period 48.0 44.0 +9.1% 116.4 96.4 +20.8% 184.7
--------------------------------------------------------------------------------
OTHER COMPREHENSIVE INCOME INCLUDING
TAX EFFECTS
--------------------------------------------------------------------------------
Change in value of cash
flow hedges -0.4 0.3 -261.9% -0.9 0.0 1.6
Change in value of
available-for-sale
financial assets -0.1 -0.2
Translation differences -0.5 1.7 -128.3% -1.0 2.1 -149.2% 1.3
Other comprehensive
income net of tax -0.9 1.9 -148.6% -2.2 2.1 -200.9% 2.9
--------------------------------------------------------------------------------
Comprehensive income for
the period including tax
effects 47.0 45.9 +2.4% 114.3 98.5 +16.0% 187.6
--------------------------------------------------------------------------------
PROFIT ATTRIBUTABLE TO:
--------------------------------------------------------------------------------
Owners of the parent
company 48.0 44.0 +9.1% 116.4 96.4 +20.8% 184.7
Non-controlling interests 0.0 0.0 0.0 0.0 0.0
--------------------------------------------------------------------------------
COMPREHENSIVE INCOME
ATTRIBUTABLE TO:
--------------------------------------------------------------------------------
Owners of the parent
company 47.0 45.9 +2.4% 114.3 98.5 +16.0% 187.6
Non-controlling interests 0.0 0.0 0.0 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Basic earnings per share,
EUR (1)) 0.34 0.31 +9.2% 0.83 0.68 +21.0% 1.31
Diluted earnings per
share, EUR (1)) 0.34 0.31 +9.2% 0.83 0.68 +21.0% 1.31
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Depreciation,
amortisation and
impairment 11.0 8.8 +25.7% 23.9 17.5 +36.9% 38.9
Personnel expenses 49.6 44.5 +11.6% 94.0 84.6 +11.2% 170.3
--------------------------------------------------------------------------------
1) The figure has been calculated from the profit attributable to the owners of
the parent company.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
ASSETS
EUR million 6/11 6/10 Change % 2010
---------------------------------------------------------
Property, plant and equipment 184.6 189.6 -2.7% 187.1
Goodwill 13.5 13.5 13.5
Intangible rights 60.3 65.4 -7.8% 65.3
Other intangible assets 4.5 3.9 +15.3% 4.2
Investments in associates 1.4 0.1 1.3
Available-for-sale investments 1.2 1.0 +22.4% 1.0
Pension asset 33.7 29.8 +13.0% 31.6
Deferred tax assets 2.7 5.7 -52.3% 2.9
Other non-current assets 2.0 0.8 +166.4% 2.4
---------------------------------------------------------
Non-current assets total 303.9 309.8 -1.9% 309.3
---------------------------------------------------------
---------------------------------------------------------
Inventories 143.0 129.6 +10.3% 131.1
Trade receivables 137.3 119.8 +14.6% 118.3
Other receivables 23.9 17.4 +37.6% 20.0
Money market investments 77.7
Cash and cash equivalents 60.4 78.9 -23.5% 89.5
---------------------------------------------------------
Current assets total 364.5 345.7 +5.5% 436.5
---------------------------------------------------------
---------------------------------------------------------
Assets total 668.5 655.5 +2.0% 745.8
---------------------------------------------------------
EQUITY AND LIABILITIES
EUR million 6/11 6/10 Change % 2010
------------------------------------------------------------------------------
Share capital 92.2 92.2 92.2
Share premium 17.8 17.8 17.8
Expendable fund 0.5 8.9 -94.5% 8.9
Other reserves 0.5 0.0 1.6
Retained earnings 294.5 263.5 +11.8% 346.8
------------------------------------------------------------------------------
Equity attributable to owners of the parent company 405.5 382.5 +6.0% 467.4
------------------------------------------------------------------------------
Non-controlling interests 0.0 0.0 +10.9% 0.0
------------------------------------------------------------------------------
Equity total 405.5 382.5 +6.0% 467.4
------------------------------------------------------------------------------
------------------------------------------------------------------------------
Deferred tax liabilities 44.7 42.3 +5.6% 44.8
Pension liability 0.7 0.8 -15.0% 0.7
Provisions 0.3 0.5 -45.4% 0.4
Interest-bearing non-current liabilities 82.6 103.7 -20.4% 87.5
Other non-current liabilities 0.1 0.3 -61.5% 0.1
------------------------------------------------------------------------------
Non-current liabilities total 128.3 147.6 -13.0% 133.6
------------------------------------------------------------------------------
------------------------------------------------------------------------------
Trade payables 40.5 37.0 +9.7% 49.0
Income tax liabilities 13.5 12.2 +10.4% 12.7
Other current liabilities 57.5 53.0 +8.5% 60.6
Provisions 0.0 0.0
Interest-bearing current liabilities 23.1 23.2 -0.3% 22.5
------------------------------------------------------------------------------
Current liabilities total 134.7 125.4 +7.4% 144.8
------------------------------------------------------------------------------
------------------------------------------------------------------------------
Liabilities total 263.0 273.0 -3.7% 278.4
------------------------------------------------------------------------------
------------------------------------------------------------------------------
Equity and liabilities total 668.5 655.5 +2.0% 745.8
------------------------------------------------------------------------------
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
a. Share capital
b. Share premium
c. Expendable fund
d. Other reserves
e. Translation differences
f. Retained earnings
g. Non-controlling interests
h. Equity total
Equity attributable to owners of the parent
company
---------------------------------------------
EUR million a. b. c. d. e. f. g. h.
--------------------------------------------------------------------------------
Equity at 1 January 2010 92.2 17.8 23.0 0.0 -5.7 311.7 0.0 439.1
--------------------------------------------------------------------------------
Profit for the period 96.4 96.4
--------------------------------------------------------------------------------
Other comprehensive
income:
--------------------------------------------------------------------------------
Change in value of cash
flow hedges 0.0 0.0
Translation differences 2.1 2.1
--------------------------------------------------------------------------------
Transactions with owners and non-controlling interests:
--------------------------------------------------------------------------------
Dividend and capital
repayment -14.1 -141.0 -155.1
Share-based incentive
plan 0.2 0.2
Equity at 30 June 2010 92.2 17.8 8.9 0.0 -3.6 267.3 0.0 382.5
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Equity at 1 January 2011 92.2 17.8 8.9 1.6 -4.4 351.2 0.0 467.4
--------------------------------------------------------------------------------
Profit for the period 116.4 116.4
--------------------------------------------------------------------------------
Other comprehensive
income:
--------------------------------------------------------------------------------
Change in value of cash
flow hedges -0.9 -0.9
Change in value of
available-for-sale
financial assets -0.2 -0.2
Translation differences -1.0 -1.0
--------------------------------------------------------------------------------
Transactions with owners and non-controlling
interests:
--------------------------------------------------------------------------------
Dividend and capital
repayment -8.5 -169.0 -177.5
Share-based incentive
plan 1.4 1.4
Other adjustments -0.2 -0.2
Equity at 30 June 2011 92.2 17.8 0.5 0.5 -
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2011 - 11:00 Uhr
Sprache: Deutsch
News-ID 56906
Anzahl Zeichen: 65679
contact information:
Town:
Espoo
Kategorie:
Business News
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Die Pressemitteilung mit dem Titel:
"Orion Group Interim Report January-June 2011"
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