Orion Group Interim Report January-September 2013
(Thomson Reuters ONE) -
ORION CORPORATION / INTERIM REPORT / JANUARY-SEPTEMBER 2013 22 October
2013 at 12:00 noon EEST
Orion's net sales in January-September 2013 totalled EUR 734 million (EUR 726
million in January- September 2012).
* Operating profit was EUR 202 (220) million.
* Profit before taxes was EUR 200 (219) million.
* Equity ratio was 52% (59%).
* ROCE before taxes was 39% (50%).
* ROE after taxes was 41% (46%).
* Basic earnings per share were EUR 1.07 (1.17).
* Cash flow per share before financial items was EUR 0.56 (0.92).
* The outlook estimate for 2013 remains unchanged. Orion estimates that in
2013 net sales will be at similar level to 2012 and that operating profit
will be slightly lower than in 2012.
* Promising results from Phase II clinical trials of ODM-201.
* Orion and Endo have terminated their collaboration agreement concerning
oncology drug research, development and commercialisation. Among others, all
the rights of ODM-201 revert to Orion.
* Orion and Hospira have extended their licensing agreement concerning the
sedative agent Precedex® in the markets outside the Europe.
ORION'S KEY FIGURES FOR THE REVIEW PERIOD
Q3/13 Q3/12 Change % Q1-Q3/13 Q1-Q3/12 Change % 2012
-------------------------------------------------------------------------------
Net sales, EUR million 236.9 245.8 -3.6% 734.3 726.0 +1.1% 980.4
-------------------------------------------------------------------------------
International
operations, EUR million 169.3 182.5 -7.3% 531.2 536.0 -0.9% 723.1
-------------------------------------------------------------------------------
% of net sales 71.5% 74.3% 72.3% 73.8% 73.8%
-------------------------------------------------------------------------------
Operating profit, EUR
million 66.6 75.6 -11.9% 201.8 219.5 -8.1% 278.3
-------------------------------------------------------------------------------
% of net sales 28.1% 30.8% 27.5% 30.2% 28.4%
-------------------------------------------------------------------------------
Profit before taxes, EUR
million 65.3 75.3 -13.4% 199.6 218.5 -8.7% 276.6
-------------------------------------------------------------------------------
% of net sales 27.6% 30.6% 27.2% 30.1% 28.2%
-------------------------------------------------------------------------------
Income tax expense, EUR
million 16.2 18.7 -13.4% 49.1 54.0 -9.2% 69.7
-------------------------------------------------------------------------------
R&D expenses, EUR
million 21.2 26.3 -19.5% 72.2 73.9 -2.3% 105.8
-------------------------------------------------------------------------------
% of net sales 9.0% 10.7% 9.8% 10.2% 10.8%
-------------------------------------------------------------------------------
Capital expenditure, EUR
million 21.1 12.7 +66.1% 57.8 36.0 +60.3% 46.8
-------------------------------------------------------------------------------
% of net sales 8.9% 5.2% 7.9% 5.0% 4.8%
-------------------------------------------------------------------------------
Assets total, EUR
million 926.8 782.7 +18.4% 835.7
-------------------------------------------------------------------------------
Equity ratio, % 51.5% 58.9% 61.0%
-------------------------------------------------------------------------------
Gearing, % 20.5% 7.7% -1.7%
-------------------------------------------------------------------------------
Interest-bearing
liabilities, EUR million 270.8 149.9 +80.7% 136.7
-------------------------------------------------------------------------------
Non-interest-bearing
liabilities, EUR million 178.5 171.7 +3.9% 189.5
-------------------------------------------------------------------------------
Cash and cash
equivalents and money
market investments, EUR
million 172.8 114.3 +51.2% 145.2
-------------------------------------------------------------------------------
ROCE (before taxes), % 39.4% 49.9% 45.9%
-------------------------------------------------------------------------------
ROE (after taxes), % 40.7% 45.6% 41.0%
-------------------------------------------------------------------------------
Basic earnings per
share, EUR 0.35 0.40 -13.4% 1.07 1.17 -8.6% 1.47
-------------------------------------------------------------------------------
Diluted earnings per
share, EUR 0.35 0.40 -13.4% 1.07 1.17 -8.6% 1.47
-------------------------------------------------------------------------------
Cash flow per share
before financial items,
EUR 0.29 0.42 -30.4% 0.56 0.92 -38.9% 1.23
-------------------------------------------------------------------------------
Equity per share, EUR 3.38 3.27 +3.4% 3.62
-------------------------------------------------------------------------------
Personnel at the end of
the period 3,530 3,489 +1.2% 3,486
-------------------------------------------------------------------------------
Average personnel during
the period 3,550 3,500 +1.4% 3,495
-------------------------------------------------------------------------------
Personnel expenses, EUR
million 156.8 154.8 +1.3% 214.8
-------------------------------------------------------------------------------
President and CEO Timo Lappalainen's review
"Year progressed as anticipated"
"Our net sales were at similar level to the previous year and as expected our
operating profit was slightly lower than in 2012.
"Deliveries of our Parkinson's drugs to Novartis were clearly lower than in the
previous year. The decrease in the past quarter was strengthened by about EUR
10 million of non-recurring compensatory payments related to pricing received in
the comparative period of 2012. Total sales generated by Stalevo(®) and
Comtess(®) products in Orion's own sales organisation were slightly down on the
comparative period.
"The entacapone molecule patent will expire in October 2013 in the United
States, where generic competition commenced in April 2012. Orion has delivered
generic entacapone products to its partners in the United States and will
continue these deliveries after the expiry of the patent. In Europe data
protection of Stalevo will expire in October 2013, after which generic
competitors can refer to results from Orion's clinical trials in their
applications for marketing authorisation. Despite intensifying generic
competition, Parkinson's drugs will continue to be an important product group
for Orion.
"Although sales of Parkinson's drugs clearly declined, net sales of the
Proprietary Products business division decreased only slightly because dexdor(®)
and Precedex(®) maintained strong growth. In addition, after the review period,
we extended the licensing agreement with Hospira concerning the sedative agent
Precedex® in the markets outside the Europe. We are also pleased that all the
other business divisions increased net sales during the year. Fermion, which
manufactures active pharmaceutical ingredients, increased sales especially
strongly.
"At the end of September we reported positive Phase II clinical trial results
for an androgen receptor antagonist (ODM-201) for the treatment of advanced
prostate cancer. The collaboration agreement with Endo Pharmaceuticals
concerning development of ODM-201 has been terminated and subject to an ongoing
royalty obligation due Endo, all rights to ODM-201 revert to Orion. Ending the
collaboration with Endo will not affect progress of the project. We have started
preparations for a Phase III clinical trial and also continue negotiations to
find a suitable partner for collaboration on the next phase of worldwide
development and commercialisation of the product. A broader collaboration
agreement between the companies concerning oncology drug research, development
and commercialisation has also been terminated. All the drug candidates covered
by the agreement and all their rights will return to respective originators.
"In addition, we have continued negotiations with possible partners for the
further development of an alpha-2c adrenoceptor antagonist (ORM-12741) being
developed for the treatment of Alzheimer's disease.
"The significant ongoing investment and production reorganisation projects have
progressed as planned during the year. Through the measures being undertaken, we
will develop and ensure future growth, delivery reliability and quality
standards. However, the projects have been temporarily increasing production
costs and decreasing production capacity, and that has reduced our margin this
year.
"Our outlook estimate, which can be found with the basis for it on pages 6-7 of
this report, remains unchanged. We estimate that our net sales will be at
similar level to the previous year and our operating profit will be slightly
lower than in 2012."
Events during the period
On 25 July Orion announced that it had reached agreement with Mylan
Pharmaceuticals Inc. in the patent dispute concerning the proprietary drug
Stalevo(®).
Events after the period
On 21 October Orion Corporation and Hospira, Inc. announced that they have
extended the licensing agreement concerning the sedative agent Precedex® in the
markets outside the Europe.
On 22 October Orion Corporation and Phyxius Pharma, Inc. announced that they
have entered into a licensing agreement for levosimendan injection in the USA
and Canada.
News conference and teleconference
A news conference and teleconference on the published results will be held
today, Tuesday 22 October 2013, 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 at
www.orion.fi/en/investors. After the presentation, questions can be asked by
telephone in Finnish and English. The teleconference code is 937158 and to
participate in the teleconference, please call:
from Finland: +358 (0)9 2313 9201
from United Kingdom: +44 (0)20 7162 0077
from Sweden: +46 (0)8 5052 0110
from United States: +1 334 323 6201
A more comprehensive list of country-specific telephone numbers can be found at
www.orion.fi/en/investors.
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 available on the Orion
website later today.
Financial report material
Financial reports and related presentation material are available at
www.orion.fi/en/investors promptly after publication. The website also has a
form for subscribing to Orion's releases.
Dates in Orion Calendar 2013-2014
Capital Markets Day in Helsinki Wednesday 20 November 2013
Financial Statement Release for 2013 Tuesday 4 February 2014
Tuesday 25 March 2014
Annual General Meeting 2014
Interim Report January-March 2014 Tuesday 29 April 2014
Interim Report January-June 2014 Tuesday 29 July 2014
Tuesday 21 October 2014
Interim Report January-September 2014
The Financial Statements and Report by the Board of Directors for 2013 will be
published on the Company's website at the latest in week 10/2014.
For additional information about the financial review:
Jari Karlson, CFO tel. +358 10 426 2883
Tuukka Hirvonen, Communications Manager tel. +358 10 426 2721 / mobile
+358 50 966 2721
www.orion.fi/en
www.orion.fi/en/investors
Financial review Q1-Q3/2013
Net sales
The Orion Group's net sales in January-September 2013 were EUR 734 million (EUR
726 million in January-September 2012). The net effect of currency exchange
rates was EUR -9 million.
The Pharmaceuticals business's net sales were EUR 693 (687) million. Net sales
of Orion's Stalevo(®) (carbidopa, levodopa and entacapone) and
Comtess(®)/Comtan(®) (entacapone) Parkinson's drugs were down by 19% at EUR 156
(192) million, which was 22% (28%) of the Pharmaceuticals business's net sales.
The net sales of other products in the portfolio were up by 9% at EUR 538 (495)
million.
The Diagnostics business's net sales were up by 6% at EUR 43 (41) million.
Operating profit
The Orion Group's operating profit was down by 8% at EUR 202 (220) million.
The Pharmaceuticals business's operating profit was down by 9% at EUR 205 (224)
million. The gross profit percentage was lower than in the comparative period
due to products with lower margins accounting for an increasing proportion of
sales, lower prices and higher production costs. Costs were increased by the
ongoing extensive investment and production facility modification projects,
which have temporarily decreased production capacity and at the same time
increased costs. Operating expenses were slightly down. Net sales and operating
profit in the comparative period were enhanced by a total of EUR 10 million of
long-term compensatory payments related to the pricing of partner deliveries.
The Diagnostics business's operating profit was up by 33% at EUR 3.9 (2.9)
million due to good growth in sales. The profit includes EUR 1.6 million of
expenses recorded in June related to contraction of the product portfolio,
closure of the Turku manufacturing plant and personnel reductions.
Operating expenses
The Group's sales and marketing expenses were down by 2% at EUR 145 (148)
million.
R&D expenses were down by 2% at EUR 72 (74) million and accounted for 10% (10%)
of the Group's net sales. Pharmaceutical R&D expenses amounted to EUR 66 (68)
million. Research projects are reported in more detail under Pharmaceuticals in
the Business Reviews.
Administrative expenses were EUR 32 (33) million.
Other operating income and expenses increased profit by EUR 3 (2) million.
Group's profit
The Group's profit before taxes totalled EUR 200 (219) million. Basic earnings
per share were EUR 1.07 (1.17) and diluted earnings per share were EUR 1.07
(1.17). Equity per share was EUR 3.38 (3.27). The return on capital employed
before taxes (ROCE) was 39% (50%) and the return on equity after taxes (ROE)
41% (46%).
Financial position
The Group's gearing was 21% (8%) and the equity ratio 52% (59%).
The Group's total liabilities at 30 September 2013 were EUR 449 (322) million.
At the end of the period, interest-bearing liabilities amounted to EUR 271 (150)
million, including EUR 241 (120) million of long-term loans.
The Group had EUR 173 (114) million of cash and cash equivalents and money
market investments 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 lower than in the comparative period at
EUR 131 (168) million. The cash flow was lower because the operating profit
decreased and the amount tied up into working capital increased by more than in
the comparative period. The clear EUR 20 million year-on-year increase in
inventories was mainly due to ensuring the reliability of deliveries as the
product portfolio and supply chain were expanded. The slightly higher amount
tied up into working capital than in the comparative period was also due to
receivables and especially other receivables such as advance payments related to
licensing agreements. In addition, income taxes paid were up by EUR 7 million on
the comparative period.
Cash flow from investing activities was EUR -52 (-38) million.
Cash flow from financing activities was EUR -51 (-139) million. The difference
was mainly due to the EUR 150 million bond issued in June 2013.
Capital expenditure
The Group's capital expenditure totalled EUR 58 (36) million. This comprised EUR
52 (30) million on property, plant and equipment and EUR 6 (6) million on
intangible assets.
Outlook for 2013
Net sales will be at similar level to 2012 (net sales in 2012 were EUR 980
million).
Operating profit will be slightly lower than in 2012 (operating profit in 2012
was EUR 278 million).
The Group's capital expenditure will be about EUR 80 million excluding
substantial corporate or product acquisitions (the Group's capital expenditure
in 2012 was EUR 47 million).
Basis for outlook
Competition in the Finnish market will remain intense in 2013. However, product
launches will continue to support Orion's position as market leader.
The generic competition that commenced in April 2012 in the United States has
decreased sales of Orion's Parkinson's drugs. The decrease will continue in
2013 because generic products will be in the markets during the whole year and,
in addition, the number of competitors will be greater than in 2012. US markets
accounted for about EUR 60 million of the net sales of Orion's Parkinson's drugs
in 2011 and about EUR 33 million in 2012. In addition, sales of generic
entacapone products to the United States amounted to about EUR 17 million in
2012.
The entacapone molecule patent expired in November 2012 in the main European
countries for Orion, and as a result there will be generic competitors to Comtan
and Comtess in these markets in 2013. Data protection of Stalevo will end in the
European Union in October 2013 and generic competition is not expected to
commence in Europe during the current year, even though the first generic
marketing authorisation application in Europe has already been submitted. The
total sales of Orion's Parkinson's drugs in Europe are expected to be slightly
lower than in 2012. Elsewhere in the world generic competition is not expected
to have a material impact on sales volumes of these products in the current
year, but declining prices and depreciation in the exchange rate of the Japanese
yen relative to the euro will decrease sales.
Net sales and operating profit in 2012 also included EUR 10 million of non-
recurring long-term compensatory payments related to the pricing of partner
deliveries.
A slight decrease in the gross profit as percentage of net sales is anticipated.
Sales of generic products will account for a greater proportion of Orion's total
sales and price competition will remain intense in many markets. In addition,
significant ongoing investments to develop and ensure future growth, delivery
reliability and quality standards, and related reorganisation of production will
temporarily decrease production capacity and increase production costs.
Marketing expenditure will be similar to the previous year. 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 2013 were planned
mainly during the previous year.
Research and development costs will be at similar level to 2012. 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 2013 are either ongoing from the previous year or at an
advanced stage of planning, therefore their cost level can be estimated rather
accurately. The accrued costs are materially affected by collaboration
arrangements and how the costs arising are allocated between Orion and its
collaboration partners.
The estimated costs of the ongoing patent litigations in the United States are
based on the planned timetables and work estimates. The costs due to the
litigations will depend on a number of factors, which are difficult to estimate
accurately.
Near-term risks and uncertainties relating to the outlook
Sales of Orion's Parkinson's drugs will decrease in 2013 due to generic
competition. The effects of the competition have been taken into account in the
outlook estimate.
Sales of individual products and also Orion's sales in individual markets may
vary, for example depending on the extent to which the ever-tougher price and
other competition prevailing in pharmaceutical markets in recent years will
specifically 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 among others
adjustments of stock levels. In addition, changes in market prices and exchange
rates affect the value of deliveries to Novartis.
A significant proportion of the exchange rate risk is related to the US dollar.
Typically, only less than 15% of Orion's net sales comes 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. Changes in the Japanese yen exchange rate have become more important
as sales of Parkinson's drugs in Japan have increased.
Orion's currently high production capacity utilisation rate and its broad
product range may cause risks to the delivery reliability and make it more
challenging than before to maintain the very high quality standard required.
Authorities and key customers in different countries undertake regular and
detailed inspections of development and manufacturing of drugs. Any remedial
actions that may be required may at least temporarily reduce delivery
reliability.
Research projects always entail uncertainty factors that may either increase or
decrease estimated costs. The projects may progress more slowly or faster than
assumed, or they may be discontinued. Nonetheless, changes that may occur in
ongoing clinical studies are reflected in costs relatively slowly, and 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 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.
Group's financial objectives
Orion's financial objectives are ensuring the Group's financial stability and
profitable growth.
These objectives are achieved through:
* Increasing net sales. Achievement of this objective requires continuous
investment in development of the product portfolio.
* Maintaining profitability at a good level, the aim being operating profit
that exceeds 20% of net sales.
* Keeping the equity ratio at least 50%.
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 September 2013 Orion had a total of 141,257,828 (141,257,828) shares, of
which 42,172,816 (44,293,218) were A shares and 99,085,012 (96,964,610) B
shares. The Group's share capital was EUR 92,238,541.46 (92,238,541.46). At the
end of September 2013 Orion held 188,991 (325,991) B shares as treasury shares.
On 30 September 2013 the aggregate number of votes conferred by the A and B
shares was 942,352,341 (982,502,979) excluding treasury shares.
At the end of September 2013, Orion had 56,142 (58,800) 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. The Company itself 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-September 2013 a total of
1,094,402 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 September 2013 the market capitalisation of the Company's shares excluding
treasury shares was EUR 2,628 million.
Orion shares are also traded on various alternative trading platforms in
addition to NASDAQ OMX Helsinki.
Authorisations of the Board of Directors
Orion's Board of Directors was authorised by the Annual General Meeting on 19
March 2013 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 is
valid for five years from the decision taken by the Annual General Meeting.
The Board of Directors is authorised to decide on acquisition of no more than
500,000 Orion Corporation B shares. Such shares shall be acquired at the market
price at the time of acquisition quoted in the regulated market of NASDAQ OMX
Helsinki Oy ("Stock Exchange") using funds in the Company's distributable
equity. Such shares may be acquired in the regulated market of the Stock
Exchange in a proportion not corresponding to the shareholders' holdings. The
shares shall be acquired and paid for in accordance with the rules of the Stock
Exchange and Euroclear Finland Ltd. The shares acquired can be kept, cancelled
or further conveyed by the Company. The shares can be acquired for the purpose
of developing the capital structure of the Company, for use in financing
possible corporate acquisitions or other business arrangements of the Company,
for financing capital expenditure, as part of the Company's incentive plan, or
for otherwise conveying or cancelling them. The Board of Directors shall decide
on other matters related to the acquisition of shares in the Company.
On 23 April 2013 Orion's Board of Directors decided to acquire shares in the
Company as authorised by the Annual General Meeting. According to the decision,
the Company will acquire 500,000 B shares in the Company. The shares will be
acquired in accordance with the terms of the authorisation by the Annual General
Meeting.
The Board of Directors is authorised to decide on conveyance of no more than
600,000 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 the regulated market of the Stock
Exchange; 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
decision to authorise the share issue revoked the unexercised portion of the
outstanding share issue authorisation approved at Orion Corporation's Annual
General Meeting on 24 March 2010.
The Board of Directors is not authorised to increase the share capital or to
issue bonds with warrants or convertible bonds or stock options.
Orion Group's 2013 long-term incentive plan
In February 2013 Orion's Board of Directors decided on a new share-based
incentive plan for key persons of the Group. The Plan includes earning periods
and the Board of Directors will annually decide on the beginning and duration of
the earning periods in 2013, 2014 and 2015. 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 35 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. The incentive plan is reported in more
detail in a stock exchange release on 5 February 2013.
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 September 2013 Orion had a total of 56,142 (58,800) registered
shareholders, of whom 95% (95%) were private individuals holding 46% (50%) of
the entire share stock and 64% (65%) of the total votes. There were altogether
48 (44) million nominee-registered shares, which was 34% (31%) of all shares,
and they conferred entitlement to 7% (6%) of the total votes.
At the end of September 2013 Orion held 188,991 (325,991) B shares as treasury
shares, which is 0.1% (0.2%) of the Company's total share stock and 0.02%
(0.03%) of the total votes.
Personnel
The average number of employees in the Orion Group in January-September 2013 was
3,550 (3,500). At the end of September 2013 the Group had a total of 3,530
(3,489) employees, of whom 2,820 (2,788) worked in Finland and 710 (701) outside
Finland.
Salaries and other personnel expenses in January-September 2013 totalled EUR
157 (155) million.
Significant legal proceedings
Legal proceedings against the Sandoz companies
On 1 May 2012 Orion announced that it had been informed that the United States
District Court for the District of New Jersey had given its decision on the
patent infringement lawsuit that Orion Corporation and Hospira, Inc. filed on 4
September 2009 to enforce US Patents Nos. 4,910,214 and 6,716,867. The
respondents in the case are Sandoz Inc., Sandoz International GmbH and Sandoz
Canada Inc. (hereinafter collectively "Sandoz").
The court found that US Patent No. 4,910,214 is valid and enforceable. Sandoz is
permanently enjoined from the commercial manufacture, use, sale or offer for
sale in the United States or importation into the United States of its generic
dexmedetomidine product until such time as US Patent No. 4,910,214 expires,
including any applicable extensions. The Court also ordered that the effective
date of Sandoz's Abbreviated New Drug Application No. 91-465 shall not occur
until the expiration of Patent No. 4,910,214, including any applicable
extensions. Separately, the court found that US Patent No. 6,716,867 is invalid
as obvious.
Orion's licensee Hospira, Inc. sells Precedex(®) in the United States and in
markets outside Europe.
Orion and Hospira have filed an appeal against the decision to the court of
appeals, and so has Sandoz.
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. Gland Pharma Ltd. has since been added as a
defendant in the lawsuit.
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 µg/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.
Business Reviews
Pharmaceuticals
Review of human pharmaceuticals market
According to statistics collected by Finnish Pharmaceutical Data Ltd, Finnish
wholesale of human pharmaceuticals in January-September 2013 was up by 2% on the
comparative period at EUR 1,520 (1,489) million.
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 and 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-September 2013 amounted to EUR 172 (162) million, up by 7% compared
with the previous year. Orion's market share of Finnish pharmaceuticals markets
was 11% (11%).
According to IMS Health pharmaceutical sales statistics, in the 12-month period
ending in June 2013 the total sales of Parkinson's drugs in the United States
were up by 8% at USD 791 million (USD 731 million in the previous 12-month
period). 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 totalled EUR 969 (951) million, and the
average market growth was 2%. In Japan sales of Parkinson's drugs were down by
2% at EUR 553 (562) million.
According to IMS Health pharmaceutical sales statistics, in the 12-month period
ending in June 2013 the total sales of Parkinson's drugs containing entacapone
were USD 175 (193) million in the United States and EUR 153 (156) million in the
five largest European markets.
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 about one-fifth of the
Group's net sales. Sales of these products clearly decreased in the United
States and slightly decreased in Europe. In Japan sales continued to grow better
than the market as a whole. According to IMS Health pharmaceutical sales
statistics, in the 12-month period ending in June 2013, sales of Orion's branded
Parkinson's drugs in the United States were down by 60% at USD 71 (177) million.
Sales were down by 3% at EUR 152 (156) million in the five largest markets in
Europe, and in Japan sales were EUR 63 (62) million. The market share of Orion's
branded Parkinson's drugs was 9% in the United States, on average 16% in the
five largest European markets and 11% in Japan.
According to IMS Health pharmaceutical sales statistics, sales of Orion's
Precedex(®) intensive care sedative (dexmedetomidine) were up by 39% at USD 321
million in the 12-month period ending in June 2013 (USD 231 million in the
previous 12-month period). About four-fifths of the sales amounting to USD 262
(180) million were in the United States, where Precedex sales grew by 46%.
According to IMS Health pharmaceutical sales statistics, total sales of the most
common intravenous anaesthetics and intensive care sedatives (propofol,
midazolam, remifentanil and dexmedetomidine) in Europe in the 12-month period
ending in June 2013 were EUR 474 (475) million. According to IMS Health
pharmaceutical sales statistics, in the 12-month period ending in June 2013
sales of Orion's dexdor(®) intensive care sedative (dexmedetomidine) were up by
259% at EUR 18 (5) million in Europe.
Net sales and operating profit of the Pharmaceuticals business
Net sales of the Pharmaceuticals business in January-September 2013 were EUR
693 (687) million. The operating profit of the Pharmaceuticals business was down
by 9% at EUR 205 (224) million. The operating profit of the Pharmaceuticals
business was 30% (33%) of the segment's net sales.
Net sales of Orion's top ten pharmaceuticals in January-September 2013 were EUR
334 (347) million. They accounted for 48% (50%) 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 Proprietary Products in January-September 2013 were down by 5% at
EUR 285 (300) million.
Orion's branded 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-September 2013 totalled EUR 156
(192) million. Sales of Parkinson's drugs were down by 19% and accounted for
22% (28%) of the total net sales of the Pharmaceuticals business. Net sales from
deliveries of Stalevo and Comtan to Novartis were down by 27% at EUR 87 (119)
million. Deliveries of Stalevo to Novartis were down by 24% at EUR 60 (78)
million and deliveries of Comtan were down by 34% at EUR 27 (41) million. Total
net sales generated by Stalevo and Comtess in Orion's own sales organisation
were down by 6% at EUR 69 (73) million. Sales through Orion's own sales network
were EUR 62 (63) million for Stalevo and down by 36% at EUR 6 (10) million for
Comtess. The entacapone molecule patent will expire in October 2013 in the
United States, where generic competition commenced in April 2012. Orion has
delivered generic entacapone products to its partners in the United States and
will continue these deliveries after the expiry of the patent. In Europe data
protection of Stalevo will expire in October 2013, after which generic
competitors can refer to results from Orion's clinical trials in their
applications for marketing authorisation.
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 undertaken epidemiological studies and
results from them were submitted to authorities for review in the third quarter
of 2012.
Net sales of Simdax(®), a drug for treatment of acute decompensated heart
failure, in January-September 2013 were up by 3% at EUR 33 (32) million.
Total net sales of the Easyhaler(®) product family for treatment of asthma and
chronic obstructive pulmonary disease were up by 3% in January-September 2013 at
EUR 21 (20) million. Sales of Easyhaler products through Orion's own sales
network in Europe continued to grow strongly. The repatriation of rights to
Easyhaler products in 2012, especially in Poland and to some extent in Germany,
and the related transitional phase slowed sales growth in the current year.
Net sales of the Precedex(®) intensive care sedative (dexmedetomidine) were up
by 43% in January-September 2013 at EUR 41 (28) million. 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. After the review
period, Orion and Hospira announced that they have extended the licensing
agreement concerning the sedative agent Precedex® in the markets outside the
Europe.
Net sales of Orion's dexdor(®) intensive care sedative (dexmedetomidine) in
January-September 2013 were up by 125% at EUR 18 (8) million. The product is
still in the launching phase, which is apparent in the quarterly fluctuation in
sales.
Specialty Products
Net sales of the Specialty Products business division's off-patent, i.e. generic
prescription drugs and self-care products in January-September 2013 were up by
4% at EUR 279 (270) million. Sales of generic entacapone products were down by
47% at EUR 7 (13) million. Sales of products from the rest of the portfolio were
up by 6%.
Net sales of Orion's human pharmaceuticals in Finland in January-September 2013
were up by 7% at EUR 188 (175) million. Specialty Products accounted for the
majority of sales. Orion managed to increase its sales, especially in
prescription drugs.
Net sales of Orion's human pharmaceuticals in Eastern Europe and Russia in
January-September 2013 were up by 14% at altogether EUR 50 (44) million.
Specialty Products account for the majority of sales in the region.
Animal Health
In the Nordic countries and some Eastern European markets Orion itself sells
veterinary drugs, and in other markets the Company operates through partners. In
addition, in the Nordic countries Orion markets and sells veterinary drugs
manufactured by several international companies. Orion's Animal Health business
division has a strong market position in the Nordic countries, its home markets.
Net sales of the Animal Health business division in January-September 2013 were
up by 2% at EUR 53 (52) million. Sales of the animal sedatives at EUR 18 (16)
million accounted for 34% (32%) of the division's net sales. Orion's animal
sedatives are Dexdomitor(®) (dexmedetomidine), Domitor(®) (medetomidine),
Domosedan(®) (detomidine) and Antisedan(®) (atipamezole).
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-September 2013 excluding
pharmaceutical ingredients supplied for Orion's own use were up by 27% at EUR
46 (36) 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. Capacity utilisation at Fermion's plants continued to
be very high during the review period. Capacity utilisation was increased by
manufacturing active ingredients required for development work on Orion's own
proprietary drugs, in addition to the normal product range.
Research and development projects
The Group's R&D expenses in January-September 2013 were down by 2% at EUR 72
(74) million, of which the Pharmaceuticals business accounted for EUR 66 (68)
million. The Group's R&D expenses accounted for 10% (10%) of the Group's net
sales. R&D expenses also include expenses related to development of the current
portfolio.
The Phase II clinical trial of an androgen receptor antagonist (ODM-201) for the
treatment of advanced prostate cancer showed that initial results concerning
efficacy were promising, and the product was well tolerated with no significant
adverse events detected. The results were presented at the international ECCO
oncology congress at the end of September 2013. Orion and Endo Pharmaceuticals,
which is part of Endo Health Solutions Inc., have terminated their collaboration
agreement concerning development of ODM-201. Subject to an ongoing royalty
obligation due Endo, all rights to ODM-201 revert to Orion and ending the
collaboration with Endo will not affect progress of the project. Orion has
commenced preparations for a Phase III clinical trial and also continues
negotiations to find a suitable partner for collaboration on the next phase of
worldwide development and commercialisation of the product. A broader
collaboration agreement between the companies concerning oncology drug research,
development and commercialisation has also been terminated. All the drug
candidates covered by the agreement and all their rights will revert to
respective originators.
Orion has ongoing projects to broaden the range of the inhalable Easyhaler(®)
drugs product family. Orion submitted an application for marketing authorisation
for a combined budesonide-formoterol formulation in Europe in March, and the
application is being processed. In this formulation, budesonide acts as an anti-
inflammatory agent and formoterol acts as a long-acting bronchodilator.
In addition, Orion has another Easyhaler research programme in progress to
develop a combined fluticasone-salmeterol formulation for European markets. 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
markets. Novartis submitted an application for marketing authorisation for the
product in June.
Orion has completed Phase II clinical trials with an alpha-2c adrenoceptor
antagonist (ORM-12741). The trials investigated the efficacy and safety of the
drug candidate in treatment of cognitive and behavioural symptoms related to
Alzheimer's disease. Positive results from Phase IIa clinical trials were
presented at the annual meeting of the American Academy of Neurology in mid-
March 2013. Negotiations to find a suitable partner for the next development
phase are ongoing. In addition, Orion has Phase I clinical pharmacokinetic
trials ongoing with another alpha-2c adrenoceptor antagonist (ODM-102), a backup
molecule to ORM-12741.
Orion is developing a new more effective levodopa product (ODM-101) based on
optimised new formulations and doses of known compounds. Results obtained from
Phase II clinical trials in 2012 were positive, and they were presented at the
annual meeting of the American Academy of Neurology in mid-March 2013. The
search for a suitable collaboration model for the next development phase is
ongoing.
Orion has ongoing Phase I clinical safety trials initiated in summer 2012 with a
new COMT inhibitor (ODM-103). In addition, Orion has started Phase I clinical
safety trials with another new COMT inhibitor (ODM-104). ODM-103 and ODM-104 are
new molecules that enhance the therapeutic effects of levodopa used to treat
Parkinson's disease by blocking the COMT enzyme. The pre-clinical study results
indicated that they are more effective than the COMT inhibitor entacapone, which
is already in the markets.
After the review period, Orion and Phyxius Pharma, Inc. entered into a licensing
agreement for levosimendan injection. According to the agreement Phyxius Pharma
will develop and commercialize levosimendan in the USA and Canada for a new
cardiovascular indication, prevention of Low Cardiac Output Syndrome (LCOS) in
cardiac surgery patients.
In addition, Orion has several projects in the early research phase
investigating cancer, neuropathic pain, Parkinson's disease and Alzheimer's
disease, among others.
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-September 2013 were up by 6% at EUR 43 (41)
million.
QuikRead(®) infection tests remained the main product, with sales continuing
strong. Launching of the QuikRead go(®) hsCRP+Hb test progressed as planned. Two
results, for CRP and haemoglobin, can be obtained from a single sample with the
test.
Through the measures decided following the co-operation negotiations, Orion
Diagnostica continued streamlining its operations according to the planned
schedule during the review period.
The operating profit of the Diagnostics business was up by 33% at EUR 3.9 (2.9)
million due to good growth in sales. The profit includes EUR 1.6 million of
expenses related to contraction of the product portfolio, closure of the Turku
manufacturing plant and personnel reductions.
Espoo, 22 October 2013
Board of Directors of Orion Corporation
Orion Corporation
Timo Lappalainen Jari Karlson
President and CEO CFO
Tables
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
EUR million Q3/13 Q3/12 Change % Q1-Q3/13 Q1-Q3/12 Change % 2012
-------------------------------------------------------------------------------
Net sales 236.9 245.8 -3.6% 734.3 726.0 +1.1% 980.4
-------------------------------------------------------------------------------
Cost of goods sold -96.3 -85.4 +12.7% -286.9 -254.4 +12.8% -350.8
-------------------------------------------------------------------------------
Gross profit 140.6 160.4 -12.3% 447.4 471.6 -5.1% 629.6
-------------------------------------------------------------------------------
Other operating income
and expenses 1.7 0.7 +123.4% 3.4 2.1 +64.2% 6.3
-------------------------------------------------------------------------------
Sales and marketing
expenses -45.1 -49.5 -8.9% -144.7 -147.8 -2.0% -206.1
-------------------------------------------------------------------------------
R&D expenses -21.2 -26.3 -19.5% -72.2 -73.9 -2.3% -105.8
-------------------------------------------------------------------------------
Administrative expenses -9.4 -9.7 -2.9% -32.1 -32.5 -1.3% -45.7
-------------------------------------------------------------------------------
Operating profit 66.6 75.6 -11.9% 201.8 219.5 -8.1% 278.3
-------------------------------------------------------------------------------
Finance income 0.6 1.4 -59.9% 3.4 4.8 -29.3% 4.9
-------------------------------------------------------------------------------
Finance expenses -1.9 -1.7 +12.0% -5.9 -5.9 +0.5% -6.6
-------------------------------------------------------------------------------
Share of associated
companies' results 0.3 0.1 +314.1% 0.1
-------------------------------------------------------------------------------
Profit before taxes 65.3 75.3 -13.4% 199.6 218.5 -8.7% 276.6
-------------------------------------------------------------------------------
Income tax expense -16.2 -18.7 -13.4% -49.1 -54.0 -9.2% -69.7
-------------------------------------------------------------------------------
Profit for the period 49.1 56.6 -13.3% 150.5 164.5 -8.5% 206.9
-------------------------------------------------------------------------------
OTHER COMPREHENSIVE INCOME
INCLUDING TAX EFFECTS
-------------------------------------------------------------------------------
Change in value of cash
flow hedges 0.0 0.0 0.1 -0.3 -0.2
-------------------------------------------------------------------------------
Change in value of
available-for-sale
financial assets 0.0 0.3 0.3
-------------------------------------------------------------------------------
Translation differences 0.8 0.6 -1.0 1.8 1.1
-------------------------------------------------------------------------------
Items that may be
reclassified
subsequently to profit
and loss 0.8 0.6 -0.9 1.9 1.1
-------------------------------------------------------------------------------
Items due to
remeasurement of
defined benefit plans 0.0 6.4 0.0 19.2 25.6
-------------------------------------------------------------------------------
Items that will not be
reclassified to profit
and loss 0.0 6.4 0.0 19.2 25.6
-------------------------------------------------------------------------------
Other comprehensive
income net of tax 0.8 7.0 -0.9 21.1 26.7
-------------------------------------------------------------------------------
Comprehensive income
for the period
including tax effects 49.9 63.6 -21.6% 149.6 185.5 -19.3% 233.7
-------------------------------------------------------------------------------
PROFIT ATTRIBUTABLE TO:
-------------------------------------------------------------------------------
Owners of the parent
company 49.1 56.6 -13.3% 150.5 164.5 -8.5% 206.9
-------------------------------------------------------------------------------
Non-controlling
interests 0.0 0.0 0.0 0.0 0.0
-------------------------------------------------------------------------------
COMPREHENSIVE INCOME
ATTRIBUTABLE TO:
-------------------------------------------------------------------------------
Owners of the parent
company 49.9 63.6 -21.6% 149.6 185.5 -19.3% 233.7
-------------------------------------------------------------------------------
Non-controlling
interests 0.0 0.0 0.0 0.0 0.0
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Basic earnings per
share, EUR (1)) 0.35 0.40 -13.4% 1.07 1.17 -8.6% 1.47
-------------------------------------------------------------------------------
Diluted earnings per
share, EUR (1)) 0.35 0.40 -13.4% 1.07 1.17 -8.6% 1.47
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Depreciation,
amortisation and
impairment 9.2 10.7 -14.7% 27.6 28.6 -3.7% 40.0
-------------------------------------------------------------------------------
Personnel expenses 45.9 47.8 -3.9% 156.8 154.8 +1.3% 214.8
-------------------------------------------------------------------------------
(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 9/13 9/12 Change % 12/12
-------------------------------------------------------------------------------
Property, plant and equipment 236.3 201.7 +17.1% 205.3
-------------------------------------------------------------------------------
Goodwill 13.5 13.5 13.5
-------------------------------------------------------------------------------
Intangible rights 56.1 62.4 -10.0% 58.0
-------------------------------------------------------------------------------
Other intangible assets 3.4 4.6 -25.8% 4.3
-------------------------------------------------------------------------------
Investments in associates 1.7 1.4 +19.1% 1.4
-------------------------------------------------------------------------------
Available-for-sale financial assets 0.5 1.1 -55.6% 0.5
-------------------------------------------------------------------------------
Pension asset 38.6 30.1 +28.3% 38.4
-------------------------------------------------------------------------------
Deferred tax assets 1.3 1.9 -27.9% 2.0
-------------------------------------------------------------------------------
Other non-current assets 1.3 1.6 -20.6% 1.6
-------------------------------------------------------------------------------
Non-current assets total 352.7 318.2 +10.8% 325.0
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Inventories 199.6 170.2 +17.3% 179.2
-------------------------------------------------------------------------------
Trade receivables 157.9 147.6 +7.0% 151.5
-------------------------------------------------------------------------------
Other receivables 43.7 32.3 +35.2% 34.8
-------------------------------------------------------------------------------
Money market investments 15.0
-------------------------------------------------------------------------------
Cash and cash equivalents 157.8 114.3 +38.0% 145.2
-------------------------------------------------------------------------------
Current assets total 574.1 464.5 +23.6% 510.7
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Assets total 926.8 782.7 +18.4% 835.7
-------------------------------------------------------------------------------
EQUITY AND LIABILITIES
EUR million 9/13 9/12 Change % 12/12
-------------------------------------------------------------------------------
Share capital 92.2 92.2 92.2
-------------------------------------------------------------------------------
Expendable fund 0.5 0.5 0.5
-------------------------------------------------------------------------------
Other reserves 1.6 0.8 +99.7% 0.8
-------------------------------------------------------------------------------
Retained earnings 383.1 367.6 +4.2% 416.0
-------------------------------------------------------------------------------
Equity attributable to owners of the parent company 477.4 461.1 +3.5% 509.5
----------------
Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: hugin
" alt="Aurcana Reports Third Quarter Production ResultsDatum: 22.10.2013 - 11:01 Uhr
Sprache: Deutsch
News-ID 307904
Anzahl Zeichen: 65675
contact information:
Town:
Espoo
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 273 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Orion Group Interim Report January-September 2013"
steht unter der journalistisch-redaktionellen Verantwortung von
Orion Oyj (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
