Orion Group Interim Report January-March 2015
(Thomson Reuters ONE) -
ORION CORPORATION / INTERIM REPORT / JANUARY-MARCH 2015 / 29 April 2015 at
12:00 noon EEST
Orion Group Interim Report January-March 2015
Orion's net sales in January-March 2015 totalled EUR 260 million (EUR 245
million in January-March 2014).
* Operating profit was EUR 83 (67) million.
* Profit before taxes was EUR 83 (66) million.
* Equity ratio was 38% (39%).
* ROCE before taxes was 50% (39%).
* ROE after taxes was 57% (47%).
* Basic earnings per share were EUR 0.47 (0.37).
* Cash flow per share before financial items was EUR 0.38 (0.30).
* The outlook estimate for 2015 was updated after the review period. Orion
estimates that in 2015 net sales will be slightly lower than in 2014 and the
operating profit is estimated to exceed EUR 230 million.
ORION'S KEY FIGURES FOR THE REVIEW PERIOD
Q1/15 Q1/14 Change % 2014
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Net sales, EUR million 259.9 245.0 +6.1% 1,015.3
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International operations, EUR million. 181.5 174.6 +4.0% 719.8
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% of net sales 69.8% 71.3% 70.9%
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Operating profit, EUR million 83.1 67.4 +23.3% 272.4
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% of net sales 32.0% 27.5% 26.8%
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Profit before taxes, EUR million 82.7 66.5 +24.4% 267.8
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% of net sales 31.8% 27.1% 26.4%
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Income tax expense, EUR million 17.0 13.9 +22.5% 56.6
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R&D expenses, EUR million 25.1 26.3 -4.6% 106.2
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% of net sales 9.7% 10.7% 10.5%
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Capital expenditure, EUR million 8.0 16.1 -50.1% 57.1
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% of net sales 3.1% 6.6% 5.6%
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Assets total, EUR million 1,070.3 1,026.9 +4.2% 1,001.5
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Equity ratio, % 38.1% 38.9% 52.3%
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Gearing, % -20.3% -0.1% -4.7%
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Interest-bearing liabilities, EUR million 230.7 253.9 -9.2% 234.5
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Non-interest-bearing liabilities, EUR million 437.8 381.0 +14.9% 252.0
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Cash and cash equivalents and money market
investments, EUR million 312.2 254.3 +22.8% 258.5
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ROCE (before taxes), % 50.4% 38.9% 36.6%
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ROE (after taxes), % 57.4% 46.5% 41.1%
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Basic earnings per share, EUR 0.47 0.37 +24.8% 1.50
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Diluted earnings per share, EUR 0.47 0.37 +24.8% 1.50
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Cash flow per share before financial items,
EUR 0.38 0.30 +24.3% 1.72
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Equity per share, EUR 2.85 2.79 +2.4% 3.66
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Personnel at the end of the period 3,418 3,482 -1.8% 3,450
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Average personnel during the period 3,418 3,485 -1.9% 3,493
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Personnel expenses, EUR million 54.3 54.7 -0.8% 219.2
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President and CEO Timo Lappalainen:
"Year started strongly"
"In the first quarter of 2015 our net sales were slightly higher and operating
profit was clearly higher than in the comparative period.
"The net sales of the Specialty Products business division continued to develop
well. As regards proprietary products, the Easyhaler(®) product family and
Dexdor(®) maintained their strong growth. Sales of Simdax(®) and Comtan(®),
which have been in the markets for a long time, were also higher than in the
previous year. Stalevo(®) and Precedex(®) sales continued to decrease due to
generic competition, but good growth in other proprietary products was able to
compensate for this decline in net sales, and as a whole the net sales of the
Proprietary Products business division were similar to the previous year. Growth
in the Animal Health business division was mainly due to good growth in sales of
the animal sedative product family and a payment related to the sale of product
rights.
"The increase in operating profit was due partly to good growth in sales, but
especially to higher gross profit. The margin level in the first quarter of the
year was improved by exchange rate changes, in addition to slightly lower
production costs.
"As we announced already in Financial Statement release, during the first
quarter of the year we commenced Phase I clinical safety trials with an
investigational CYP17 enzyme and androgen receptor inhibitor (ODM-204) for
treatment of castration-resistant prostate cancer, and with a GABA-B receptor
positive allosteric modulator (ODM-106) for alleviation of symptoms of essential
tremor.
"We have also commenced Phase I clinical safety trials with a novel, highly
potent, selective and reversible negative allosteric modulator of the TRPA1 ion
channel (ODM-108) for treatment of neuropathic pain. Our clinical drug
development pipeline will be further strengthened when we commence Phase II
clinical trials with orally administered levosimendan (ODM-109) for treatment of
patients with amyotrophic lateral sclerosis (ALS). Our other research projects
progressed as planned during the review period.
"Based on the good start for the year we have updated our outlook estimate for
2015. Extension of generic competition to Stalevo outside Germany did not yet
significantly affect the first quarter figures. During the current year the
steadily growing business areas such as Specialty Products, Dexdor and the
Easyhaler product family will not be able to compensate fully for the decrease
in net sales and operating profit due to some rapid changes, such as extension
of generic competition to Stalevo in Europe, declining royalties from Precedex
and the timing of milestone payments. We estimate that in 2015 net sales will be
slightly lower than in 2014. We estimate that operating profit will exceed EUR
230 million. Our outlook estimate and the basis for it can be found in this
report under 'Outlook for 2015' and 'Basis for outlook'."
Events during the period
On 2 March Orion transferred altogether 141,949 Orion Corporation B shares held
by the Company as a share bonus for the earning periods 2012-2014 and 2014 to
the persons employed by the Group and belonging to the Share-based Incentive
Plan for key persons of the Group.
On 24 March Orion Corporation's Annual General Meeting was held in Helsinki.
Events after the period
On 24 April Orion upgraded the full-year outlook for 2015.
News conference and teleconference
A news conference and teleconference on the published results will be held
today, Wednesday 29 April 2015, 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 Orion's website at
www.orion.fi/en/investors. After the presentation, questions can be asked by
telephone in Finnish and English.
The teleconference code is 952732 and the telephone numbers to participate in
the teleconference are:
Finland: +358 (0)9 2313 9201
Sweden: +46 (0)8 5052 0110
United Kingdom: +44 (0)20 7162 0077
United States: +1 334 323 6201
News conference recordings
A recording of the webcast of the event in English and a recording of the
presentation by the President and CEO in Finnish will be published on the Orion
website during Wednesday 29 April 2015.
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 2015
Capital Markets Day 2015 Tuesday 26 May 2015
Interim Report January-June 2015 Tuesday 28 July 2015
Tuesday 27 October 2015
Interim Report January-September 2015
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
http://www.orion.fi/en
http://www.orion.fi/en/investors
Financial review January-March 2015
Net sales
The Orion Group's net sales in January-March 2015 were EUR 260 million (EUR 245
million in January-March 2014). The net effect of currency exchange rates was
plus EUR 8 million.
The Pharmaceuticals business's net sales were EUR 244 (229) million. Net sales
of Orion's Stalevo(®) (carbidopa, levodopa and entacapone) and
Comtess(®)/Comtan(®) (entacapone) Parkinson's drugs were down by 10% at EUR 42
(47) million, which was 17% (21%) of the Pharmaceuticals business's net sales.
The Pharmaceuticals business's net sales of products in the portfolio other than
Stalevo(®) and Comtess(®)/Comtan(®) and excluding milestone payments were up by
8% at EUR 197 (182) million.
The Diagnostics business's net sales were EUR 16 (16) million.
Operating profit
The Orion Group's operating profit was up by 23% at EUR 83 (67) million.
Milestone payments accounted for EUR 5 (0) million of the operating profit.
The Pharmaceuticals business's operating profit was up by 22% at EUR 81 (67)
million. Milestone payments accounted for EUR 5 (0) million of the operating
profit. The gross profit percentage on product sales was slightly higher due to
lower production costs and changes in exchange rates.
The Diagnostics business's operating profit was up by 55% at EUR 4.0 (2.6)
million mainly due to exchange rate changes and the favourable margin structure
of sales from the portfolio.
Operating expenses
The Group's sales and marketing expenses were EUR 47 (46) million.
R&D expenses were EUR 25 (26) million and accounted for 10% (11%) of the Group's
net sales. Pharmaceutical R&D expenses amounted to EUR 23 (24) million. Research
projects are reported in more detail under Pharmaceuticals in the Business
Reviews.
Administrative expenses were EUR 12 (9) million.
Other operating income and expenses, mainly derived from currency hedges,
reduced profit by EUR 2 (0) million.
Group's profit
The Group's profit before taxes totalled EUR 83 (66) million. Basic earnings per
share were EUR 0.47 (0.37) and diluted earnings per share were EUR 0.47 (0.37).
Equity per share was EUR 2.85 (2.79). The return on capital employed before
taxes (ROCE) was 50% (39%) and the return on equity after taxes (ROE) 57% (47%).
Financial position
The Group's gearing was -20% (0%) and the equity ratio 38% (39%).
The Group's total liabilities at 31 March 2015 were EUR 669 (635) million. At
the end of the period, interest-bearing liabilities amounted to EUR 231 (254)
million, including EUR 206 (229) million of non-current loans. The non-interest-
bearing liabilities in 2014 and 2015 include the dividends (EUR 183 million)
transferred from equity in March but not paid until the beginning of April.
The Group had EUR 312 (254) million of cash and cash equivalents and money
market investments at the end of the period. The cash and cash equivalents are
invested in short-term interest-bearing instruments issued by financially solid
financial institutions and corporations.
Cash flow
Cash flow from operating activities was EUR 63 (59) million. The increase in
cash flow was due to the improvement in operating profit. The amount of cash
tied up in working capital in the first quarter was slightly higher than in the
comparative period.
Cash flow from investing activities was EUR -10 (-16) million.
Cash flow from financing activities was EUR -4 (-4) million.
Capital expenditure
The Group's capital expenditure totalled EUR 8 (16) million. This comprised EUR
7 (15) million on property, plant and equipment and EUR 1 (1) million on
intangible assets.
New outlook for 2015, provided on 24 April 2015
Net sales will be slightly lower than in 2014 (net sales were EUR 1,015 million
in 2014).
Operating profit is estimated to exceed EUR 230 million.
The Group's capital expenditure will be about EUR 50 million excluding
substantial corporate or product acquisitions (the Group's capital expenditure
was EUR 57 million in 2014).
Previous outlook for 2015, provided on 4 February 2015
Net sales will be slightly lower than in 2014 (net sales were EUR 1,015 million
in 2014).
Operating profit is estimated to exceed EUR 200 million.
The Group's capital expenditure will be about EUR 50 million excluding
substantial corporate or product acquisitions (the Group's capital expenditure
was EUR 57 million in 2014).
Basis for outlook
A financial objective of Orion is to increase net sales. During the current year
the steadily growing business areas such as Specialty Products, Dexdor(®) and
the Easyhaler(®) product family will not be able to compensate fully for the
decreases in net sales and operating profit due to some rapid changes, such as
extension of generic competition to Stalevo(®) in Europe, decreasing royalties
from Precedex(®) and the timing of milestone payments. For these reasons among
others, net sales are not expected to grow in 2015. However, operating profit is
estimated to remain above 20% of net sales, in line with the financial
objectives. The negative impact due to Stalevo and Precedex is expected to level
out in 2016 as growth in other areas starts to have a positive effect on
development of the entire company.
Orion's Parkinson's drugs are Comtess(®), Comtan(®) and Stalevo(®). Generic
competition to them commenced in the United States in 2012, and in 2014 US
markets accounted for about EUR 12 million of Orion's EUR 169 million total net
sales of Parkinson's drugs. In Europe the majority of net sales come from
Stalevo. Generic competition to Comtess and Comtan, which have clearly lower
sales, commenced already in 2013. The first generic marketing authorisations for
Stalevo were granted in Germany and generic competition commenced there in
2014. The competition is expected to extend in Europe during 2015 and decrease
Orion's sales of Stalevo. In 2014 Europe accounted for about EUR 111 million of
the net sales of Orion's Parkinson's drugs. Elsewhere in the world generic
competition is not expected to have a material impact on sales volumes of these
products in the current year.
In the United States two competitor companies received marketing authorisation
for their own generic versions of Precedex in August 2014. In addition, the
agreement previously reached with Sandoz was amended in September 2014 to allow
Sandoz to launch its generic version earlier than originally agreed. Following
these changes, the royalties from Precedex received by Orion decreased. They
were EUR 10 million in the second half of 2014, which was 64% less than in the
corresponding period a year earlier. The decline is continuing in 2015, and
royalties will be clearly lower than in 2014.
Sales of Dexdor and the Easyhaler product family, which are also key proprietary
drugs, are forecast to continue to grow. The patent for the Simdax(®) molecule
expires in September 2015 but this is not expected to have a material impact on
sales in the current year.
Sales of generic products have been accounting for a greater proportion of
Orion's total sales, and price competition has remained intense in many markets.
Competition in Finland, the most important generic market for Orion, remains
intense in 2015. However, product launches continue to support Orion's position
as market leader.
Collaboration agreements with other pharmaceutical companies are an important
component of Orion's business model. Often payments related to these agreements
are recorded in net sales, and in 2014 they totalled EUR 39 million. In the
first quarter of 2015 milestone payments totalled EUR 5 million. Forecasting the
timing and amount of payments is difficult. Possible future payments relating to
agreements already made have in some cases been conditional on, for instance,
the progress of research projects or results received, which are not known until
studies have been completed. On the other hand, making new agreements is
generally a process for which neither the schedule nor the outcome is known
before the final signing of the agreement.
Investments commenced in 2012 to develop and ensure future growth, delivery
reliability and quality standards, and the related reorganisations of production
will mostly be completed during 2015. They are no longer expected materially to
decrease production capacity and increase production costs. Projects launched as
part of the reorganisations to increase production efficiency are expected
gradually to improve productivity from the beginning of 2015.
Marketing expenditure will be at similar level 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 2015 were planned
mainly during the previous year. Royalty payments to AbbVie previously recorded
in marketing expenditure and related to the reacquisition of rights to Simdax
ended in April 2014. About EUR 10 million of royalties were paid in 2013 and
about EUR 3 million in 2014.
Research and development costs will be slightly higher than in 2014. 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 2015 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. For instance, Bayer is paying the majority of the ODM-
201 research costs.
Near-term risks and uncertainties
Sales of Orion's Parkinson's drugs will decrease in 2015 due to generic
competition. The effects of the competition have been taken into account in the
outlook estimate for the current year. However, the timing of commencement and
the intensity of generic competition to Stalevo in Europe still entails
uncertainty that may materially affect the accuracy of the estimate made at this
stage. Competition is expected to have extended in Europe by the end of 2015,
decreasing Stalevo sales.
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 of Parkinson's drugs to
Novartis, the most important collaboration partner, are based on timetables that
are jointly agreed in advance. Nevertheless, they can change, for example as a
consequence of decisions by Novartis concerning among others adjustments of
stock levels. In addition, changes in market prices and exchange rates affect
the value of deliveries to Novartis.
A significant proportion of the exchange rate risk is related to the US dollar.
Typically, 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. In 2014 rapid and severe
weakening of the Russian rouble towards the end of the year had a negative
currency exchange rate effect. However, Russian sales are not a significant
portion of Orion's entire net sales.
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 have effects that decrease
delivery reliability and increase costs.
Research projects always entail uncertainty factors that may either increase or
decrease estimated costs. The projects may progress more slowly or faster than
assumed, or they may be discontinued. Nonetheless, changes that may occur in
ongoing clinical studies are reflected in costs relatively slowly, and they are
not expected to have a material impact on earnings in the current year. Owing to
the nature of the research process, the timetables and costs of new studies that
are being started are known well in advance. They therefore typically do not
lead to unexpected changes in the estimated cost structure. Orion generally
undertakes the last, in other words Phase III, clinical trials in collaboration
with other pharmaceutical companies. Commencement of these collaboration
relationships and their structure also materially affect the schedule and cost
level of research projects.
Collaboration arrangements are an important component of Orion's business model.
Possible collaboration and licensing agreements related to these arrangements
also often include payments to be recorded in net sales that may materially
affect Orion's financial results. In 2014 a total of EUR 39 million of such
payments were received, which was clearly higher than average for the payments
received by Orion in previous years. The payments may be subject to certain
conditions relating to the development of research projects or sales, and
whether these conditions are triggered and the timing of triggering always
entail uncertainties.
Orion's dividend distribution policy
Orion's dividend distribution takes into account the distributable funds and the
capital expenditure and other financial requirements in the medium and long term
to achieve the financial objectives.
Shares and shareholders
On 31 March 2015 Orion had a total of 141,257,828 (141,257,828) shares, of which
40,412,981 (42,022,816) were A shares and 100,844,847 (99,235,012) B shares. The
Group's share capital was EUR 92,238,541.46 (92,238,541.46). At the end of March
2015 Orion held 427,716 (569,665) B shares as treasury shares. On 31 March 2015
the aggregate number of votes conferred by the A and B shares was 908,676,751
(939,121,667) excluding treasury shares.
At the end of March 2015, Orion had 51,872 (55,473) registered shareholders.
Voting rights conferred by shares
Each A share entitles its holder to twenty (20) votes at General Meetings of
Shareholders and each B share one (1) vote. However, a shareholder cannot vote
more than 1/20 of the aggregate number of votes from the different share classes
represented at a General Meeting of Shareholders. The Company itself and Orion
Pension Fund do not have the right to vote at an Orion Corporation General
Meeting of Shareholders.
Both share classes, A and B, confer equal rights to the Company's assets and
dividends.
Conversion of shares
The Articles of Association entitle shareholders to demand the conversion of
their A shares to B shares within the limitation on the maximum number of shares
of a class. No shares were converted in January-March 2015.
Trading in Orion's shares
Orion's A shares and B shares are quoted on NASDAQ Helsinki in the Large Cap
group under the Healthcare sector heading under the trading codes ORNAV and
ORNBV. Trading in both of the Company's share classes commenced on 3 July 2006,
and information on trading in the Company's shares has been available since this
date.
On 31 March 2015 the market capitalisation of the Company's shares was EUR
3,695 million.
Orion shares are also traded on various alternative trading platforms in
addition to NASDAQ Helsinki.
Authorisations of the Board of Directors
Orion's Board of Directors was authorised by the Annual General Meeting on 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 was utilised during 2013. The Board of Directors is authorised to
decide on conveyance of no more than 600,000 Orion Corporation B shares held by
the Company. The authorisation to issue shares is valid for five years from the
decision taken by the Annual General Meeting. The terms and conditions of the
authorisations were reported in more detail in a stock exchange release on 19
March 2013.
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
Orion has a currently operating share-based incentive plan for key persons of
the Group, which was announced in a stock exchange release published on 5
February 2013.
On 2 March 2015 Orion transferred altogether 141,949 Orion Corporation B shares
held by the Company as a share bonus for earning periods 2012-2014 and 2014 to
the key persons employed by the Orion Group and belonging to the incentive plans
of the Orion Group.
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 March 2015 Orion had a total of 51,872 (55,473) registered
shareholders, of whom 95% (95%) were private individuals holding 42% (45%) of
the entire share stock and 62% (62%) of the total votes. There were altogether
55 (49) million nominee-registered shares, which was 39% (35%) of all shares,
and they conferred entitlement to 8% (7%) of the total votes.
At the end of March 2015 Orion held 427,716 (569,665) B shares as treasury
shares, which is 0.3% (0.4%) of the Company's total share stock and 0.05%
(0.06%) of the total votes.
Decisions by the Annual General Meeting
The Annual General Meeting of the Shareholders of Orion Corporation was held on
24 March 2015 at the Helsinki Fair Centre. The following matters among others
were handled at the meeting.
Adoption of the financial statements for financial year 1 January to 31 December
2014
The Annual General Meeting adopted the financial statements of the Company and
Group as per 31 December 2014.
Dividend EUR 1.30 per share
A dividend of EUR 1.30 per share was approved in accordance with the Board's
proposal. The record date for dividend distribution was 26 March 2015 and the
payment date was 2 April 2015.
Discharge from liability
The members of the Board of Directors and the President and CEO were discharged
from liability for the financial year 1 January to 31 December 2014.
Remuneration of the members of the Board of Directors
As the annual fees for the term of office of the Board of Directors, the
Chairman shall receive EUR 76,000, the Vice Chairman shall receive EUR 51,000
and the other Board members shall receive EUR 38,000 each. Furthermore, as a fee
for each meeting attended, the Chairman shall receive EUR 1,200, the Vice
Chairman shall receive EUR 900 and the other Board members shall receive EUR
600 each. The travel expenses of Board members shall be paid in accordance with
previous practice. The aforementioned meeting fees shall also be paid to the
Chairmen and to the members of the committees established by the Board.
Of the aforementioned annual fees, 60% was to be paid in cash and 40% in the
Company's shares, so Orion Corporation B shares were acquired in the period 30
March to 2 April 2015 from the stock exchange in amounts corresponding to EUR
30,400 for the Chairman, EUR 20,400 for the Vice Chairman and EUR 15,200 for
each of the other Board members. The part of the annual fee paid in cash, which
corresponds to the approximate sum necessary for the payment of the income taxes
on the fees, was to be paid no later than 30 April 2015. The annual fees
encompass the full term of office of the Board of Directors.
Members and Chairman of the Board of Directors
The number of members in the Board of Directors was confirmed to be seven. Sirpa
Jalkanen, Eero Karvonen, Timo Maasilta, Mikael Silvennoinen, Hannu Syrjänen,
Heikki Westerlund and Jukka Ylppö were re-elected as members of the Board of
Directors for the following term of office. Hannu Syrjänen was re-elected as the
Chairman of the Board of Directors.
Auditor and auditor's fee
Authorised Public Accountants PricewaterhouseCoopers Oy were elected as the
auditor for the following term of office. PricewaterhouseCoopers Oy announced
that Authorized Public Accountant Kalle Laaksonen is the principally responsible
auditor. The auditor's fee shall be paid against an invoice approved by the
Company.
Constitution of the Board of Directors
At its constitutive meeting following the Annual General Meeting, the Board of
Directors elected Jukka Ylppö as its Vice Chairman.
Personnel
The average number of employees in the Orion Group in January-March 2015 was
3,418 (3,485). At the end of March 2015 the Group had a total of 3,418 (3,482)
employees, of whom 2,745 (2,797) worked in Finland and 673 (685) outside
Finland.
Salaries and other personnel expenses in January-March 2015 totalled EUR 54 (55)
million.
Significant legal proceedings
Legal proceedings in the United States concerning patent No. 6,716,867
Orion Corporation, Hospira, Inc., Sun Pharmaceutical Industries, Inc.
(previously Caraco Pharmaceutical Laboratories, Ltd.) and Gland Pharma Ltd. have
entered into a settlement agreement regarding a patent infringement lawsuit that
Orion and Hospira filed in the United States in 2010 to enforce their joint
patent No. 6,716,867, which protects Orion's proprietary drug Precedex®
(dexmedetomidine hydrochloride 100 µg/ml).
There are also other infringement lawsuits pending in the United States relating
to patent No. 6,716,867 with Orion and Hospira as plaintiffs. However, in the
current market conditions and as to their costs, these proceedings are not
material for Orion, and therefore Orion will no longer report on them.
In addition, companies belonging to the Orion Group are parties to other legal
disputes that are not considered to be significant legal proceedings for the
Group.
Business Reviews
Pharmaceuticals
Review of human pharmaceuticals market
Finland is the most important individual market for Orion, generating about one-
third of the total net sales. According to IMS Health statistics, Finnish
wholesale of human pharmaceuticals in January-March 2015 was up by 2% on the
previous year at EUR 521 (513) million. Orion was able to increase its sales
faster than market growth, and maintained its position as leader in marketing
pharmaceuticals in Finland. According to statistics collected by IMS Health,
Orion's wholesale of human pharmaceuticals in Finland in January-March 2015
amounted to EUR 63 (59) million, up by 7% compared with the previous year.
Orion's market share of Finnish pharmaceuticals markets was 12% (11%).
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-sixth of the
Group's net sales.
Total sales of all Parkinson's drugs:
EUR or USD million 2014 2013 Change %
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United States USD 816 765 +7%
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Europe TOP 5 EUR 992 985 +1%
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Japan EUR 507 495 +2%
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Source: IMS Health pharmaceutical sales statistics MAT12/2014 (1/2014-12/2014)
The five largest European markets for Parkinson's disease drugs were Germany,
the United Kingdom, France, Spain and Italy.
Total sales of all Parkinson's drugs containing entacapone:
EUR or USD million 2014 2013 Change %
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United States USD 108 144 -25%
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Europe TOP 5 EUR 144 152 -5%
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Japan EUR 54 55 -2%
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Source: IMS Health pharmaceutical sales statistics MAT12/2014 (1/2014-12/2014)
Total sales of Orion's branded Parkinson's drugs:
EUR or USD million 2014 2013 Change %
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United States USD 17 31 -45%
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Europe TOP 5 EUR 123 130 -5%
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Japan EUR 54 55 -2%
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Source: IMS Health pharmaceutical sales statistics MAT12/2014 (1/2014-12/2014)
Sales of Orion's branded Parkinson's drugs decreased in the United States due
the trend to generics in the market and in Japan due to depreciation of the yen
exchange rate. The market share of Orion's branded Parkinson's drugs was 2% in
the United States, on average 12% in the five largest European markets and 11%
in Japan.
According to IMS Health pharmaceutical sales statistics, sales of Precedex(®)
intensive care sedative (dexmedetomidine) were down by 7% at USD 346 million in
the 12-month period ending in December 2014 (USD 371 million in the previous 12-
month period). The largest market, with sales of USD 280 (310) million, was the
United States, where Precedex sales were down by 10%. The decrease in sales was
due to generic competition, which commenced in the United States in August 2014.
According to IMS Health pharmaceutical sales statistics, in Europe total sales
of the most common intravenous anaesthetics and intensive care sedatives
(propofol, midazolam, remifentanil and dexmedetomidine) in the 12-month period
ending in December 2014 were up by 3% at EUR 509 (494) million. According to IMS
Health pharmaceutical sales statistics, in the 12-month period ending in
December 2014 sales of Orion's Dexdor(®) intensive care sedative
(dexmedetomidine) were up by 28% at EUR 28 (22) million in Europe.
Net sales and operating profit of the Pharmaceuticals business
Net sales of the Pharmaceuticals business in January-March 2015 were up by 7% at
EUR 245 (229) million. The operating profit of the Pharmaceuticals business was
EUR 81 (67) million, including milestone payments of EUR 5 (0) million. The
operating profit of the Pharmaceuticals business was 33% (29%) of the segment's
net sales.
Net sales of Orion's top ten pharmaceuticals in January-March 2015 were up by
3% at EUR 110 (108) million. They accounted for 45% (47%) of the total net sales
of the Pharmaceuticals business.
Proprietary Products
The product portfolio of Proprietary Products consists of patented prescription
products in three therapy areas: central nervous system diseases, oncology and
critical care, and Easyhaler(®) pulmonary drugs.
Net sales of Proprietary Products in January-March 2015 were EUR 89 (88)
million.
Orion's drugs for treatment of Parkinson's disease are Stalevo(®) (active
ingredients carbidopa, levodopa and entacapone) and Comtess(®)/Comtan(®)
(entacapone). Their total net sales in January-March 2015 were down by 10% at
EUR 42 (47) million. In the United States Orion's Parkinson's drugs have several
generic competitors. In Europe Comtess and Comtan have several generic
competitors. Generic competition to Stalevo commenced in Germany in 2014 and
competition has started to extend in Europe.
Breakdown of sales of Parkinson's drugs:
EUR million Q1/2015 Q1/2014 Change %
--------------------------------------------------------
Stalevo deliveries to Novartis 20 19 +4%
--------------------------------------------------------
Comtan deliveries to Novartis 10 7 +43%
--------------------------------------------------------
Orion's Stalevo sales 11 20 -42%
--------------------------------------------------------
Orion's Comtess sales 2 2 -16%
--------------------------------------------------------
Net sales of Simdax(®), a drug for treatment of acute decompensated heart
failure, in January-March 2015 were up by 19% at EUR 13 (11) million.
Total net sales of the Easyhaler(®) product family for treatment of asthma and
chronic obstructive pulmonary disease were up by 59% in January-March 2015 at
EUR 12 (8) million. The increase was due to good development of sales of
monoproducts that have been on the markets for a long time and sales of Bufomix
Easyhaler(®) (budesonide-formoterol), the new combined formulation in the
product family. Sales of Bufomix Easyhaler totalled EUR 3 (0) million in
January-March 2015. The product received national marketing authorisation during
the review period in Greece and processing of the national phase of marketing
authorisation application is still ongoing in Italy. Sales of Bufomix Easyhaler
have commenced in more than ten countries, but because it is not within generic
substitution in pharmacies, growth is slower than for ordinary generic products,
especially in the launch phase.
Net sales of the Precedex(®) intensive care sedative (dexmedetomidine) were down
by 49% in January-March 2015 at EUR 5 (9) million. In the United States and
markets outside Europe the sedative is sold by Orion's partner Hospira. Most of
the net sales of Precedex has come from the United States, where generic
competition commenced in August 2014.
Net sales of Orion's Dexdor(®) intensive care sedative (dexmedetomidine) in
January-March 2015 were up by 40% at EUR 11 (8) million.
Specialty Products
Net sales of the Specialty Products business division's off-patent, i.e. generic
prescription drugs, self-care products and biosimilars in January-March 2015
were up by 6% at EUR 109 (102) million. Sales of generic entacapone products
were down by 9% at EUR 6 (7) million. Sales of products from the rest of the
portfolio were up by 8%.
Finland, Scandinavia, and Eastern Europe and Russia are the most important
markets for Specialty Products. The business division's sales in Finland in
January-March 2015 were up by 7% at EUR 65 (61) million. Orion managed to
increase its sales, especially in prescription drugs. Sales were up by 20% at
EUR 15 (12) million in Scandinavia and sales were up by 2% at EUR 12 (11)
million in Eastern Europe and Russia. Depreciation of the rouble weakened
development of the euro value of sales in Eastern Europe and Russia. Sales
measured in local currency grew in Russia.
Net sales of Remsima(®) for treatment of rheumatoid arthritis among other things
were EUR 3 (1) million in January-March 2015. Remsima is a biosimilar infliximab
developed and manufactured by Orion's collaboration partner, for which Orion has
marketing rights in Finland, Scandinavia and Estonia.
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 other 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-March 2015 were up
by 40% at EUR 22 (15) million. The increase was mainly due to good growth in
sales of the animal sedative product family and a non-recurring milestone
payment recorded on the sale of product rights. Sales of the animal sedative
product family at EUR 7 (5) million accounted for 32% (32%) of the division's
net sales. The product family comprises Orion's animal sedatives Dexdomitor(®)
(dexmedetomidine), Domitor(®) (medetomidine) and Domosedan(®) (detomidine), and
antagonist Antisedan(®) (atipamezole), which reverses the effects of the
sedatives.
At the end of the review period Morrr Oy, which is owned by Orion, launched in
Finland and Sweden a beta version of the digital Morrr(®) service
(www.morrr.com) for pet owners. The aim of the service, which is to become
international, is to connect pet owners and professionals offering services to
them. Morrr will help owners of domestic animals find the best services and
products for their pets, and for professionals Morrr offers a marketing channel
for their services and products.
Fermion
Fermion manufactures active pharmaceutical ingredients for Orion and other
pharmaceutical companies. Its product range comprises nearly 30 pharmaceutical
ingredients. For other pharmaceutical companies Fermion manufactures generic
pharmaceutical ingredients and offers contract manufacturing services for
development and manufacturing of new active pharmaceutical ingredients.
Fermion's net sales in January-March 2015 excluding pharmaceutical ingredients
supplied for Orion's own use were EUR 15 (15) 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. Arto Toivonen became
President of Fermion on 1 January 2015.
Research and development projects
The Group's R&D expenses in January-March 2015 were EUR 25 (26) million, of
which the Pharmaceuticals business accounted for EUR 23 (24) million. The
Group's R&D expenses accounted for 10% (11%) of the Group's net sales. R&D
expenses also include expenses related to development of the current portfolio.
In 2014 Orion commenced global collaboration with Bayer in the development and
commercialisation of an investigational novel oral androgen receptor inhibitor
(ODM-201). ODM-201 is in clinical development for the treatment of patients with
prostate cancer. Bayer and Orion jointly have started a Phase III clinical trial
for further evaluation of the efficacy and safety of ODM-201 in patients with
non-metastatic castration-resistant prostate cancer (nm-CRPC).
Orion has an ongoing project to broaden the range of the Easyhaler(®) product
family. Orion is developing a fluticasone-salmeterol combined formulation for
European markets. In this formulation fluticasone acts as an anti-inflammatory
agent and salmeterol acts as a long-acting bronchodilator.
Orion has ongoing additional trials with the Bufomix Easyhaler(®) combined
formulation (budesonide-formoterol). The aim is to obtain marketing
authorisation for the product in at least some of the European countries that
were not included in the decentralised marketing authorisation application
process. In this formulation budesonide acts as an anti-inflammatory agent and
formoterol acts as a long-acting bronchodilator.
Orion is continuing development of an alpha-2c adrenoceptor antagonist (ORM-
12741) for treatment of symptoms of Alzheimer's disease in collaboration with
Janssen Pharmaceuticals Inc. In the initial Phase IIa clinical trial conducted
by Orion, the efficacy and safety of the drug candidate in treatment of
cognitive and behavioural symptoms related to Alzheimer's disease were
investigated with positive results. In 2014 Orion and Janssen focussed on
optimising the drug composition, and Orion is preparing to commence a new Phase
IIa clinical trial with the drug candidate.
Orion is commencing Phase II clinical trials with orally administered
levosimendan (ODM-109) for treatment of patients with amyotrophic lateral
sclerosis (ALS). Levosimendan is a troponin C selective calcium sensitiser
enhancing cardiac and skeletal muscle function. Available studies indicate that
ODM-109 has the potential to support diaphragm and thus respiratory function as
well as strength and endurance of other skeletal muscles in patients with ALS.
Orion is preparing to commence Phase II clinical trials with a new COMT
inhibitor (ODM-104)
that enhances the therapeutic effects of levodopa used to treat Parkinson's
disease by blocking the COMT enzyme. The pre-clinical and pharmacokinetic study
results indicated that it is more effective than the COMT inhibitor entacapone,
which is already in the markets.
Orion has ongoing Phase I clinical safety trials with a new targeted FGFR+VEGFR
inhibitor (ODM-203) for treatment of cancers. Pre-clinical study results
indicate that ODM-203 slows growth of certain solid cancerous tumours.
Orion has commenced Phase I clinical safety trials with a unique investigational
CYP17 enzyme and androgen receptor inhibitor (ODM-204). The pre-clinical study
results indicated that ODM-204 blocks the growth of castration-resistant
prostate cancer (CRPC).
Orion has commenced Phase I safety trials with a GABA-B receptor positive
allosteric modulator (ODM-106) for alleviation of symptoms of essential tremor
(ET). Preclinical studies indicate that ODM-106 has the potential to alleviate
essential tremor, parkinsonian tremor and levodopa-induced dyskinesia in
patients with Parkinson's disease, without causing sedation.
Orion has commenced Phase I clinical safety trials with a novel, highly potent,
selective and reversible negative allosteric modulator of Transient Receptor
Potential A1 (TRPA1) ion channel (ODM-108) for treatment of neuropathic pain.
ODM-108 did not demonstrate sedation when tested at pre-clinically effective
doses and is optimised for good absorption.
Orion's partner Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics, Inc.)
will develop and commercialise levosimendan in US and Canadian markets for a new
cardiovascular indication, prevention of low cardiac output syndrome (LCOS) in
cardiac surgery patients. The company has an ongoing Phase III clinical trial
for this indication. In addition, the company is investigating the possibility
of gaining an additional indication of septic shock for levosimendan.
Orion's collaboration partner Recro Pharma, Inc. is developing an intranasal
formulation of dexmedetomidine for treatment of pain. Recro has an ongoing Phase
IIb clinical trial with patients suffering from post-operative pain.
In addition, Orion has several projects in the early research phase
investigating central nervous system diseases, cancer and neuropathic pain,
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-March 2015 were EUR 16 (16) million.
QuikRead(®) infection tests remained the main product, with sales continuing to
increase. Launching of the first Orion GenRead(®) test system products, an
instrument and a C. difficile test that were released for sale at the end of
2014, continued during the review period. The C. difficile test is for detecting
intestinal Clostridium difficile infection occurring during antibiotic
treatment. Orion GenRead(®) is based on an isothermal nucleic acid amplification
technique, SIBA(® )technology.
During the review period the QuikRead go(®) Feeder instrument gained the CE
mark, which allows sales of the product to commence within the EU. QuikRead go
Feeder automates and speeds up taking measurements with QuikRead go instruments.
It is intended for healthcare sites where many samples are handled and
measurements are taken continuously.
The operating profit of the Diagnostics business was up by 55% at EUR 4.0 (2.6)
million. The growth was mainly due to exchange rate changes and the favourable
margin structure of sales from the portfolio.
Espoo, 29 April 2015
Board of Directors of Orion Corporation
Orion Corporation
Timo Lappalainen Jari Karlson
President and CEO CFO
Tables
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
EUR million Q1/15 Q1/14 Change % 2014
-------------------------------------------------------------------------------
Net sales 259.9 245.0 +6.1% 1,015.3
-------------------------------------------------------------------------------
Cost of goods sold -91.4 -95.8 -4.6% -401.7
-------------------------------------------------------------------------------
Gross profit 168.5 149.2 +13.0% 613.6
-------------------------------------------------------------------------------
Other operating income and
expenses -2.2 0.2 1.7
-------------------------------------------------------------------------------
Sales and marketing expenses -46.6 -46.3 +0.6% -193.4
-------------------------------------------------------------------------------
R&D expenses -25.1 -26.3 -4.6% -106.2
-------------------------------------------------------------------------------
Administrative expenses -11.5 -9.4 +23.2% -43.3
-------------------------------------------------------------------------------
Operating profit 83.1 67.4 +23.3% 272.4
-------------------------------------------------------------------------------
Finance income 0.6 0.2 +264.3% 0.8
-------------------------------------------------------------------------------
Finance expenses -1.4 -1.5 -6.9% -5.9
-------------------------------------------------------------------------------
Share of associated companies'
results 0.4 0.4 +5.1% 0.4
-------------------------------------------------------------------------------
Profit before taxes 82.7 66.5 +24.4% 267.8
-------------------------------------------------------------------------------
Income tax expense -17.0 -13.9 +22.5% -56.6
-------------------------------------------------------------------------------
Profit for the period 65.7 52.6 +24.9% 211.3
-------------------------------------------------------------------------------
OTHER COMPREHENSIVE INCOME
INCLUDING TAX EFFECTS
-------------------------------------------------------------------------------
Change in value of cash flow
hedges 0.0 0.0 0.0
-------------------------------------------------------------------------------
Change in value of available-
for-sale investments 0.5 4.1
-------------------------------------------------------------------------------
Translation differences 2.5 0.2 0.6
-------------------------------------------------------------------------------
Items that may be reclassified
subsequently to profit and loss 3.1 0.2 4.7
-------------------------------------------------------------------------------
Items due to remeasurement of
defined benefit plans -0.3 0.0 -41.3
-------------------------------------------------------------------------------
Items that will not be
reclassified to profit and loss -0.3 0.0 -41.3
-------------------------------------------------------------------------------
Other comprehensive income net
of tax 2.8 0.2 -36.5
-------------------------------------------------------------------------------
Comprehensive income for the
period including tax effects 68.5 52.8 +29.8% 174.7
-------------------------------------------------------------------------------
PROFIT ATTRIBUTABLE TO:
-------------------------------------------------------------------------------
Owners of the parent company 65.7 52.6 +24.9% 211.3
-------------------------------------------------------------------------------
Non-controlling interests 0.0 0.0 0.0
-------------------------------------------------------------------------------
COMPREHENSIVE INCOME
ATTRIBUTABLE TO:
-------------------------------------------------------------------------------
Owners of the parent company 68.5 52.8 +29.8% 174.7
-------------------------------------------------------------------------------
Non-controlling interests 0.0 0.0 0.0
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Basic earnings per share, EUR
(1)) 0.47 0.37 +24.8% 1.50
-------------------------------------------------------------------------------
Diluted earnings per share, EUR
(1)) 0.47 0.37 +24.8% 1.50
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Depreciation, amortisation and
impairment 9.9 9.3 +5.8% 39.6
-------------------------------------------------------------------------------
Personnel expenses 54.3 54.7 -0.8% 219.2
-------------------------------------------------------------------------------
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 3/15 3/14 Change % 12/14
-------------------------------------------------------------------------------
Property, plant and equipment 268.5 254.8 +5.4% 269.1
-------------------------------------------------------------------------------
Goodwill 13.5 13.5 13.5
-------------------------------------------------------------------------------
Intangible rights 45.9 52.6 -12.9% 47.7
-------------------------------------------------------------------------------
Other intangible assets 2.6 3.1 -14.5% 2.7
-------------------------------------------------------------------------------
Investments in associates 2.6 2.1 +21.0% 2.1
-------------------------------------------------------------------------------
Available-for-sale investments 6.2 0.5 5.6
-------------------------------------------------------------------------------
Pension asset 25.1 -100.0%
-------------------------------------------------------------------------------
Deferred tax assets 7.6 1.0 +636.3% 6.7
-------------------------------------------------------------------------------
Other non-current assets 1.7 1.2 +45.7% 1.6
-------------------------------------------------------------------------------
Non-current assets total 348.5 354.0 -1.5% 349.1
-------------------------------------------------------------------------------
Unternehmensinformation / Kurzprofil:
Datum: 29.04.2015 - 11:01 Uhr
Sprache: Deutsch
News-ID 389334
Anzahl Zeichen: 65659
contact information:
Town:
Espoo
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 138 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Orion Group Interim Report January-March 2015"
steht unter der journalistisch-redaktionellen Verantwortung von
Orion Oyj (Nachricht senden)
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