Orion Group Interim Report January-September 2016
(Thomson Reuters ONE) -
ORION CORPORATION / INTERIM REPORT / JANUARY-SEPTEMBER 2016 / 25 October
2016 at 12:00 noon EEST
Orion Group Interim Report January-September 2016
Orion's net sales in January-September 2016 totalled EUR 794 million (EUR 754
million in January-September 2015).
* Operating profit was EUR 256 (216) million.
* Operating profit includes about EUR 22 million of capital gains received in
the third quarter.
* Profit before taxes was EUR 253 (213) million.
* Equity ratio was 60% (53%).
* ROCE before taxes was 45% (40%).
* ROE after taxes was 45% (44%).
* Basic earnings per share were EUR 1.43 (1.20).
* Cash flow per share before financial items was EUR 1.23 (1.11).
* The outlook estimate for 2016 remains unchanged. Orion estimates that in
2016 net sales will be slightly higher than in 2015. Operating profit
excluding possible capital gains is estimated to exceed EUR 270 million.
ORION'S KEY FIGURES FOR THE REVIEW PERIOD
Q3/16 Q3/15 Change % 9M 2016 9M 2015 Change % 2015
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Net sales, EUR million 258.6 239.1 +8.2% 793.6 754.0 +5.3% 1,015.6
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Operating profit, EUR
million 92.0 58.6 +57.1% 255.9 215.6 +18.7% 266.6
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% of net sales 35.6% 24.5% 32.2% 28.6% 26.2%
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Profit before taxes, EUR
million 91.0 57.0 +59.5% 253.2 212.6 +19.1% 262.3
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% of net sales 35.2% 23.9% 31.9% 28.2% 25.8%
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Income tax expense, EUR
million 18.5 11.7 +58.1% 51.8 43.8 +18.1% 54.2
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R&D expenses, EUR
million 26.9 23.3 +15.6% 80.3 76.5 +5.0% 108.1
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% of net sales 10.4% 9.7% 10.1% 10.1% 10.6%
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Capital expenditure, EUR
million 11.8 11.0 +7.1% 34.0 30.3 +12.4% 44.5
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% of net sales 4.5% 4.6% 4.3% 4.0% 4.4%
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Assets total, EUR
million 998.6 974.0 +2.5% 1,047.4
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Equity ratio, % 59.5% 52.5% 57.4%
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Gearing, % -4.2% -0.1% -9.6%
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Interest-bearing
liabilities, EUR million 173.3 219.7 -21.1% 187.8
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Non-interest-bearing
liabilities, EUR million 236.4 249.3 -5.2% 264.6
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Cash and cash
equivalents and money
market investments, EUR
million 198.2 220.2 -10.0% 245.2
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ROCE (before taxes), % 45.2% 40.1% 35.7%
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ROE (after taxes), % 45.4% 44.1% 37.5%
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Basic earnings per
share, EUR 0.52 0.32 +60.3% 1.43 1.20 +19.4% 1.48
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Diluted earnings per
share, EUR 0.52 0.32 +60.3% 1.43 1.20 +19.4% 1.48
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Cash flow per share
before financial items,
EUR 0.67 0.44 +51.6% 1.23 1.11 +10.7% 1.51
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Equity per share, EUR 4.19 3.59 +16.9% 4.22
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Personnel at the end of
the period 3,445 3,392 +1.6% 3,401
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Average personnel during
the period 3,442 3,442 3,431
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Personnel expenses, EUR
million 162.3 163.3 -0.6% 220.6
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President and CEO Timo Lappalainen:
"Business developed well - capital gains enhanced strong operating profit
growth"
"In January-September 2016 our net sales and operating profit were higher than
in January-September 2015. The clear growth in operating profit is explained by
the growth in net sales and about EUR 22 million of total capital gains received
in the third quarter.
"As regards our key proprietary products, the Dexdor sedative used in intensive
care and Easyhaler product family for treatment of asthma and chronic
obstructive pulmonary disease maintained their strong growth. Sales of Simdax
for treatment of acute decompensated heart failure also continued to grow well.
After the review period, through the decentralised procedure the budesonide-
formoterol Easyhaler combined formulation received marketing authorisation for
Germany, where the national approval process has commenced. Sales of Orion's
branded Parkinson's drugs Stalevo, Comtess and Comtan continued to decline, but
more slowly than expected.
"Net sales of the Specialty Products business division rose in all the key
market areas: Finland, Scandinavia and Eastern Europe. As regards the business
division's products, sales of the biosimilar Remsima remained strong relative to
the comparative period, but the growth rate has clearly slowed since the start
of the year due to the timings of tendering competitions and periods covered by
delivery agreements.
"There have been changes in our clinical pharmaceutical development portfolio
since the summer. We are commencing a new Phase I clinical trial with a BET
protein inhibitor (ODM-207) which inhibit transcription of key oncogenes in many
cancers. We have decided to discontinue trials with a CYP17 enzyme and androgen
receptor inhibitor (ODM-204) for treatment of castration-resistant prostate
cancer based on the pharmacokinetic findings of the Phase I clinical trial.
Other ongoing clinical pharmaceutical development projects in various phases
have progressed as planned.
"Our outlook estimate for 2016 remains unchanged. We estimate that in 2016 net
sales will be slightly higher than in 2015. We estimate that operating profit
excluding possible capital gains will exceed EUR 270 million. Our outlook
estimate and the basis for it can be found in this report under 'Outlook for
2016' and 'Basis for outlook'."
Events during the period
On 18 July Orion sold its shares in Pharmaservice Oy to Oriola-KD Corporation.
On 2 September Orion and Menarini commenced collaboration in marketing the
budesonide-formoterol Easyhaler(®) combined formulation.
On 5 September Orion sold its shares in Ekokem Corporation to Fortum
Corporation.
Events after the period
On 12 October the budesonide-formoterol Easyhaler(®) combined formulation
received marketing authorisation for Germany through the decentralised procedure
(DCP).
News conference and teleconference
A news conference and teleconference on the published results will be held
today, Tuesday 25 October 2016, 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
http://www.orion.fi/en/investors. After the presentation, questions can be asked
by telephone in Finnish and English.
The teleconference code is 3897800 and the telephone numbers to participate in
the teleconference are:
Finland: +358 (0)9 7479 0404
Sweden: +46 (0)8 5065 3942
United Kingdom: +44 (0)20 7026 5967
United States: +1 719 325 2202
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 Tuesday 25 October 2016.
Financial report material
Financial reports and related presentation material are available at
http://www.orion.fi/en/investors promptly after publication. The website also
has a form for subscribing to Orion's releases.
Dates in Orion Calendar 2017
Financial Statement Release for 2016 Wednesday 8 February 2017
Planned to be held on Wednesday 22
Annual General Meeting 2017 March 2017
Interim Report January-March 2017 Wednesday 26 April 2017
Half-Year Financial Report January-June Wednesday 19 July 2017
2017
Thursday 26 October 2017
Interim Report January-September 2017
The Financial Statements and Report by the Board of Directors for 2016 will be
published on the Company's website at the latest in week 9/2017.
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-September 2016
Net sales
The Orion Group's net sales in January-September 2016 were up by 5% at EUR 794
million (EUR 754 million in January-September 2015). The net effect of currency
exchange rates was minus EUR 9 million.
The Pharmaceuticals business's net sales were up by 6% at EUR 754 (714) million.
The Pharmaceuticals business's net sales of products in the portfolio other than
Stalevo(®), Comtess(®)/Comtan(®) and Precedex(®), and excluding milestone
payments, were up by 7% at EUR 626 (584) million. Net sales of Orion's
Stalevo(®) (carbidopa, levodopa and entacapone) and Comtess(®)/Comtan(®)
(entacapone) Parkinson's drugs were down by 9% at EUR 102 (112) million, which
was 14% (16%) of the Pharmaceuticals business's net sales.
The Diagnostics business's net sales were down by 3% at EUR 41 (43) million.
Operating profit
The Orion Group's operating profit was up by 19% at EUR 256 (216) million.
Milestone payments accounted for EUR 11 (5) million of the operating profit.
Operating profit growth was enhanced by about EUR 22 million of capital gains.
The Pharmaceuticals business's operating profit was up by 18% at EUR 257 (217)
million. Milestone payments accounted for EUR 11 (5) million of the operating
profit.
The Diagnostics business's operating profit was down by 2% at EUR 6.6 (6.8)
million.
Operating expenses
The Group's sales and marketing expenses were EUR 137 (138) million.
R&D expenses were EUR 80 (77) million and accounted for 10% (10%) of the Group's
net sales. Pharmaceutical R&D expenses amounted to EUR 75 (71) million. Research
projects are reported in more detail under Pharmaceuticals in the Business
Reviews.
Administrative expenses were EUR 34 (34) million.
Other operating income and expenses were EUR 22 (1) million. They comprise
mainly about EUR 22 million of capital gains.
Group's profit
The Group's profit before taxes was up by 19% at EUR 253 (213) million. Basic
earnings per share were EUR 1.43 (1.20) and diluted earnings per share were EUR
1.43 (1.20). Equity per share was EUR 4.19 (3.59). The return on capital
employed before taxes (ROCE) was 45% (40%) and the return on equity after taxes
(ROE) 45% (44%).
Financial position
The Group's gearing was -4% (0%) and the equity ratio 60% (53%).
The Group's total liabilities at 30 September 2016 were EUR 410 (469) million.
At the end of the period, interest-bearing liabilities amounted to EUR 173 (220)
million, including EUR 150 (200) million of long-term loans.
The Group had EUR 198 (220) 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 181 (188) million. The decrease in
cash flow was primarily due to the increase in working capital, which in turn is
mostly explained by the clear decrease in non-interest-bearing liabilities
compared with the end of the 2015.
Cash flow from investing activities was EUR -8 (-31) million, the change
relative to the comparative period being explained mostly by the sales of
shares.
Cash flow from financing activities was EUR -216 (-199) million. The change is
mainly due to purchasing of the Company's shares in June (EUR -17 million). The
purchase of own shares was based on the decision by the Board of Directors which
was announced in a stock exchange release on 27 April 2016.
Capital expenditure
The Group's capital expenditure totalled EUR 34 (30) million. This comprised EUR
29 (26) million on property, plant and equipment and EUR 4 (3) million on
intangible assets.
Outlook for 2016 (updated on 15 June 2016)
Net sales are estimated to be slightly higher than in 2015 (net sales were EUR
1,016 million in 2015).
Operating profit excluding possible capital gains is estimated to exceed EUR
270 million (operating profit was EUR 267 million in 2015).
Basis for outlook
The outlook estimate does not include capital gains, such as capital gains on
the sales of shares in Ekokem Corporation and Pharmaservice Oy. No other
significant capital gains are expected during the remainder of 2016.
A financial objective of Orion is to increase net sales. In 2016 steadily
growing products such as Dexdor(®) and the Easyhaler(®) product family are
expected to be able to compensate for the decrease in net sales due to extension
of generic competition to Stalevo(®).
Orion's Parkinson's drugs are Comtess(®), Comtan(®) and Stalevo(®). Generic
competition to them commenced in the United States in 2012 and in Europe in
2013. In the United States competition has decreased Orion's sales of these
products to low levels, but in Europe the impact has so far been less. During
2016 the competition is expected to extend in Europe. In 2015 Europe accounted
for about EUR 80 million of the net sales of Orion's Parkinson's drugs.
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
expired in September 2015 but this is not expected to have a material impact on
sales of the product in the current year.
Sales of generic products have been accounting for a significant proportion of
Orion's total sales, and price competition has continued in many markets.
Competition in Finland, the most important generic market for Orion, remains
intense in 2016. In addition, at the beginning of the current year there was in
Finland a change to a system in which a pharmacy is always obliged to recommend
to the customer the cheapest substitutable generic prescription drug. The
potential negative impact of this change on Orion's sales has been taken into
account in the outlook estimate. However, product launches continue to support
Orion's position as market leader. In the first half of 2016 sales of Remsima(®)
generated a significant portion of the growth in the net sales of the Speciality
Products business division. In the second half of the year the growth is
expected to slow due to the timing of tendering competitions for Remsima.
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 they totalled EUR 8 million in 2015 and EUR 39
million in 2014. 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
were mostly 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 in the current and coming years. However, at
the same time depreciation on property, plant and equipment (EUR 30 million in
2015) has grown to about EUR 5 million higher than in 2012. In 2016 the Group's
total capital expenditure is expected to be higher than in 2015, when it was EUR
43 million.
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 2016 were planned
mainly during the previous year.
Research and development costs will be slightly higher than in 2015. 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 2016 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 2016 due to generic
competition. The effects of the competition have been taken into account in the
outlook estimate for the current year. However, the timing of the extension and
intensity of generic competition to Stalevo in Europe still entails uncertainty
that may materially affect the accuracy of the estimate made at this stage.
Competition is expected to extend in Europe during 2016, decreasing Stalevo
sales. The basic Simdax and Dexdor patents have expired. However, the products
have other still valid product protection. Nevertheless, for these products
there is a possibility that generic competition might commence before expiry of
the respective product protection. Orion has become aware that a marketing
authorisation application for a generic version of Dexdor has been submitted in
some European countries. Orion has commenced actions to defend its rights.
Sales of individual products and also Orion's sales in individual markets may
vary, for example depending on the extent to which the ever-tougher price and
other competition prevailing in 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.
The exchange rate risk due to the US dollar has decreased in recent years
because the share of Orion's net sales invoiced in dollars has fallen to below
ten per cent. The greatest exchange rate risk at present relates to European
currencies such the Swedish crown and British pound. Possible Brexit is
estimated not to have material impact on Orion in the near term. However, the
overall effect of the risk due to currencies of European countries will be
abated by the fact that Orion has organisations of its own in most of these
countries, which means that in addition to sales income, there are also costs in
these currencies. Changes in the Japanese yen exchange rate have become more
important as sales of Parkinson's drugs in Japan have increased. The exchange
rate effect related to the Russian rouble has increased due to the strong
volatility of the currency. However, Russian sales are not a significant portion
of Orion's entire net sales.
Orion's broad product range may cause risks to the delivery reliability and make
it challenging to maintain the high quality standard required in production.
Authorities and key customers in different countries undertake regular and
detailed inspections of development and manufacturing of drugs at Orion's
production sites. Any remedial actions that may be required may at least
temporarily have effects that decrease delivery reliability and increase costs.
Orion's product range also includes products manufactured by other
pharmaceutical companies. Possible problems related to the delivery reliability
or quality of the products of those manufacturers may cause a risk to Orion's
delivery reliability.
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 received in 2015 totalled EUR
8 million. The payments may be subject to certain conditions relating to the
development of research projects or sales, and whether these conditions are
triggered and the timing of triggering always entail uncertainties.
Orion's dividend distribution policy
Orion's dividend distribution takes into account the distributable funds and the
capital expenditure and other financial requirements in the medium and long term
to achieve the financial objectives.
Shares and shareholders
On 30 September 2016 Orion had a total of 141,257,828 (141,257,828) shares, of
which 38,581,154 (39,191,154) were A shares and 102,676,674 (102,066,674) B
shares. The Group's share capital was EUR 92,238,541.46 (92,238,541.46). At the
end of September 2016 Orion held 783,366 (427,716) B shares as treasury shares.
On 30 September 2016 the aggregate number of votes conferred by the A and B
shares was 873,516,388 (885,462,038) excluding treasury shares.
At the end of September 2016, Orion had 48,824 (49,219) 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. In January-September 2016 325,000 shares were converted.
Trading in Orion's shares
Orion's A shares and B shares are quoted on Nasdaq Helsinki in the Large Cap
group under the Healthcare sector heading under the trading codes ORNAV and
ORNBV. Trading in both of the Company's share classes commenced on 3 July 2006,
and information on trading in the Company's shares has been available since this
date.
On 30 September 2016 the market capitalisation of the Company's shares,
excluding treasury shares, was EUR 4,918 million.
Orion shares are also traded on various alternative trading platforms in
addition to Nasdaq Helsinki.
Authorisations of the Board of Directors
Orion's Board of Directors was authorised by the Annual General Meeting on 22
March 2016 to decide on acquisition of shares in the Company and on a share
issue in which shares held by the Company can be conveyed.
On 27 April 2016 Orion's Board of Directors decided to acquire shares in the
Company as authorised by the Annual General Meeting. In the period 3-15 June
2016 the Company acquired 500,000 B shares in the Company in accordance with the
decision. The shares were acquired for use as part of the Orion Group's
incentive plans. Following the acquisitions, the Board of Directors does not
have any outstanding authorisation to decide to acquire shares in the Company.
The Board of Directors is authorised to decide on conveyance of no more than
600,000 Orion Corporation B shares held by the Company. The authorisation to
issue shares is valid for five years from the decision taken by the Annual
General Meeting. The terms and conditions of the authorisation were reported in
more detail in a stock exchange release on 22 March 2016.
The Board of Directors is not authorised to increase the share capital or to
issue bonds with warrants or convertible bonds or stock options.
Share-based Incentive Plan
Orion Group's Long-Term Incentive Plan 2016
In February 2016 the Board of Directors of Orion Corporation 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 2016, 2017 and 2018. 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 a maximum of 50 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 2 February 2016.
Share ownership
Orion's shares are in the book-entry system maintained by Euroclear Finland, and
Euroclear Finland maintains Orion's official shareholder register.
At the end of September 2016, Orion had a total of 48,824 (49,219) registered
shareholders, of whom 96% (96%) were private individuals holding 40% (41%) of
the entire share stock and 61% (62%) of the total votes. There were altogether
59 (59) million nominee-registered shares, which was 42% (42%) of all shares,
and they conferred entitlement to 9% (9%) of the total votes.
At the end of September 2016 Orion held 783,366 (427,716) B shares as treasury
shares, which is 0.55% (0.3%) of the Company's total share stock and 0.09%
(0.05%) of the total votes.
Personnel
The average number of employees in the Orion Group in January-September 2016 was
3,442 (3,442). At the end of September 2016 the Group had a total of 3,445
(3,392) employees, of whom 2,784 (2,722) worked in Finland and 661 (670) outside
Finland.
Salaries and other personnel expenses in January-September 2016 totalled EUR
162 (163) million.
Significant legal proceedings
Companies belonging to the Orion Group are parties to various legal disputes,
which are not, however, considered to be significant legal proceedings for the
Group.
Business 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-September 2016 was up by 4% on the
previous year at EUR 1,680 (1,620) million. Orion was able to increase its sales
faster than market growth, and strengthened 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-September 2016
amounted to EUR 217 (195) million, up by 12% compared with the previous year.
Orion's market share of Finnish pharmaceuticals markets was 13% (12%).
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 under 15% of the Group's net
sales.
Total sales of all Parkinson's drugs:
EUR or USD million MAT6/2016 MAT6/2015 Change %
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United States USD 876 850 +3%
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Europe TOP 5 EUR 919 956 -4%
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Japan EUR 608 543 +12%
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Source: IMS Health pharmaceutical sales statistics MAT6/2016 (7/2015-6/2016)
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 MAT6/2016 MAT6/2015 Change %
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United States USD 71 96 -26%
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Europe TOP 5 EUR 118 135 -12%
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Japan EUR 72 60 +21%
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Source: IMS Health pharmaceutical sales statistics MAT6/2016 (7/2015-6/2016)
Total sales of Orion's branded Parkinson's drugs:
EUR or USD million MAT6/2016 MAT6/2015 Change %
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United States * USD 9 14 -34%
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Europe TOP 5 EUR 80 108 -25%
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Japan EUR 72 60 +21%
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Source: IMS Health pharmaceutical sales statistics MAT6/2016 (7/2015-6/2016)
*) Sales of generic entacapone products by Sandoz, which is part of the
Novartis Group, were previously included in US sales but are no longer
included.
Sales of Orion's branded Parkinson's drugs decreased in Europe due to
commencement of generic competition. Sales increased in Japan mainly because
Stalevo was launched in that market during 2015. The market share of Orion's
branded Parkinson's drugs was 1% in the United States, on average 9% in the five
largest European markets and 12% in Japan.
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 June 2016 were up by 4% at EUR 530 (511) million. According to IMS
Health pharmaceutical sales statistics, sales of Orion's Dexdor(®) intensive
care sedative (dexmedetomidine) were up by 26% at EUR 41 (32) million in Europe.
Net sales and operating profit of the Pharmaceuticals business
In January-September 2016 the Pharmaceuticals business's net sales were EUR 754
(714) million and its operating profit was EUR 257 (217) million. Milestone
payments accounted for EUR 11 (5) million of the net sales and operating profit,
and comprised mainly a milestone payment of EUR 5 million from Bayer related to
ODM-201 project technology transfer and milestone payments related to marketing
rights to the Easyhaler product family. The operating profit of the
Pharmaceuticals business was 34% (30%) of the segment's net sales.
Net sales of Orion's top ten pharmaceuticals in January-September 2016 were up
by 9% at EUR 337 (310) million. They accounted for 45% (43%) of the total net
sales of the Pharmaceuticals business. Net sales of the Pharmaceuticals business
other than Stalevo(®), Comtess(®)/Comtan(®) and Precedex(®) and excluding
milestone payments were up by 7% at EUR 626 (584) million.
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 2016 were up by 10% at
EUR 269 (244) million. Growth was enhanced by higher milestone payments than in
the previous year, but product sales were also higher than in the comparative
period. Sales of Parkinson's drugs continued to decline, but this decline was
compensated by the good growth in sales of other products.
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-September 2016 were down by 9% at
EUR 102 (112) million. In the United States Orion's Parkinson's drugs have
several generic competitors. In Europe Comtess and Comtan have several generic
competitors, and generic competition to Stalevo is extending. In addition, in
certain countries compulsory price reductions related to the opening of the
market to generic competition are reducing Orion's sales. In Japan the first
marketing authorisations for generic Comtan products were granted, but generic
competition has not yet commenced.
Breakdown of sales of Parkinson's drugs:
EUR million 9M 2016 9M 2015 Change %
--------------------------------------------------------
Stalevo deliveries to Novartis 54 51 +5%
--------------------------------------------------------
Comtan deliveries to Novartis 22 25 -12%
--------------------------------------------------------
Orion's Stalevo sales 23 31 -25%
--------------------------------------------------------
Orion's Comtess sales 3 5 -36%
--------------------------------------------------------
Net sales of Simdax(®), a drug for treatment of acute decompensated heart
failure, in January-September 2016 were up by 9% at EUR 41 (37) million. Simdax
is sold in altogether over fifty countries worldwide.
Total net sales of the Easyhaler(®) product family for treatment of asthma and
chronic obstructive pulmonary disease were up by 28% in January-September 2016
at EUR 47 (37) million. The increase was mainly due to sales of the Bufomix
Easyhaler(®) combined formulation (budesonide-formoterol). Sales of Bufomix
Easyhaler were up by 78% at EUR 20 (11) million in January-September 2016. After
the review period, through the decentralised procedure the budesonide-formoterol
Easyhaler combined formulation received marketing authorisation for Germany,
where the national approval process has commenced. Processing of marketing
authorisation applications for the combined formulation is ongoing in the United
Kingdom and France. Orion is expanding Easyhaler production at the Espoo
pharmaceuticals production plant. Orion has entered into a collaboration
agreement with Menarini for the co-marketing of the budesonide-formoterol
Easyhaler(®) combined formulation in Germany, Italy, Spain and Portugal. In
addition, the parties have agreed an exclusive licence and distribution
arrangement for Menarini in France and Turkey.
Net sales of Orion's Dexdor(®) intensive care sedative (dexmedetomidine) in
January-September 2016 were up by 26% at EUR 41 (32) 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-September
2016 were up by 10% at EUR 372 (339) million. Sales of generic entacapone
products were down by 44% at EUR 10 (17) million. Sales of products from the
rest of the portfolio were up by 13%. About one-third of this growth came from
the biosimilar Remsima(®).
Finland, Scandinavia, and Eastern Europe and Russia are the most important
markets for Specialty Products. The business division's sales in Finland in
January-September 2016 were up by 8% at EUR 218 (201) million. Orion managed to
increase its sales, especially in prescription drugs. Sales were up by 19% at
EUR 60 (51) million in Scandinavia and up by 10% at EUR 41 (38) million in
Eastern Europe and Russia.
Net sales of Remsima(®) for treatment of rheumatoid arthritis among other things
were EUR 31 (17) million in January-September 2016. In the first half of 2016
the product grew especially strongly because Orion won many tendering
competitions in 2015, such as the national tendering competition in Denmark,
which were not yet apparent in sales in the first half of 2015. The reason for
the clear slowdown in growth apparent in the third quarter is that Orion did not
win the national tendering competition in Norway for the twelve-month period
beginning in March 2016, and a significant portion of net sales came from
Denmark, which was already contributing to sales in the comparative period.
Remsima is a biosimilar infliximab developed and manufactured by Orion's
collaboration partner, for which Orion has marketing rights in the Nordic
countries 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-September 2016 were
down by 10% at EUR 54 (59) million. A large part of the decrease in net sales is
explained by the milestone payment recorded on the sale of product rights
included net sales in the comparative period. Sales of the animal sedative
product family at EUR 16 (21) million accounted for 29% (35%) 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.
Sales of Sileo(®) launched in 2015 and indicated for alleviation of fear
associated with noise in dogs have started well, especially thanks to the
deliveries made to the partner in the United States. Net sales of Sileo in
January-September 2016 were EUR 4 million.
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-September 2016 excluding pharmaceutical
ingredients supplied for Orion's own use were down by 24% at EUR 33 (43) million
and accounted for over one-half of Fermion's entire net sales.
Research and development projects
The Group's R&D expenses in January-September 2016 were EUR 80 (77) million, of
which the Pharmaceuticals business accounted for EUR 75 (71) 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.
In 2014 Orion commenced global collaboration with Bayer in the development and
commercialisation of a novel oral androgen receptor antagonist (ODM-201). The
companies have an ongoing joint Phase III clinical trial (ARAMIS) for evaluation
of the efficacy and safety of ODM-201 in patients with non-metastatic
castration-resistant prostate cancer (nmCRPC).
Orion and Bayer have agreed to expand the ODM-201 development programme and
during 2016 commence a new Phase III trial (ARASENS) that will evaluate the
efficacy and safety of the drug candidate in combination with standard androgen
deprivation therapy (ADT) and the chemotherapy drug docetaxel in patients having
newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who are
starting hormone therapy.
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. In autumn 2015 Orion
completed the additional trials with the budesonide-formoterol combined
formulation in the Easyhaler(®) product family. Processing of the marketing
authorisation applications submitted is ongoing in France and the United Kingdom
based on the results received. 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. Orion has an ongoing Phase IIa clinical trial with
a new drug formulation. 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.
Orion has an ongoing Phase II clinical trial 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
levosimendan 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 has commenced a Phase II clinical trial with a drug candidate for
treatment of symptoms of Parkinson's disease in which the COMT inhibitor (ODM-
104) developed by Orion is combined with the pharmaceutical ingredients
carbidopa and long-acting levodopa used to treat Parkinson's disease. In the
trial the efficacy of the drug candidate in treating symptoms of Parkinson's
disease will be investigated and the product will be compared with a Stalevo
product already in the markets in which the active ingredients are the COMT
inhibitor entacapone, carbidopa and levodopa.
Orion has an ongoing Phase II clinical trial with a new targeted FGFR+VEGFR
inhibitor (ODM-203) for treatment of cancers. The trial will investigate the
efficacy of the drug candidate in slowing the growth of solid cancerous tumours
in patients in which FGFR changes in cancerous tumours have been detected.
Orion has decided to discontinue trials with a CYP17 enzyme and androgen
receptor inhibitor (ODM-204) for treatment of castration-resistant prostate
cancer (CRPC) based on the pharmacokinetic findings of the Phase I clinical
trial.
Orion is commencing a Phase I clinical trial with the BET protein inhibitor
(ODM-207) which inhibit transcription of key oncogenes such as Myc in many
cancers. In preclinical studies, ODM-207 has shown antiproliferative effects in
several solid tumour cell lines. The trial will investigate the safety and the
tolerability of ODM-207 and provisionally will assess antitumour activity in
cancer patients.
Orion's partner Tenax Therapeutics, 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, Tenax was investigating the possibility of gaining an additional
indication of septic shock for levosimendan, but the clinical trial results
reported in October did not support further development for this indication.
Orion's collaboration partner Recro Pharma, Inc. is developing an intranasal
formulation of dexmedetomidine for treatment of pain. Recro has decided to
change the target indication from post-operational pain to peri-procedural pain.
The company has announced that it is planning to commence a new clinical Phase
II trial concerning the new indication.
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-September 2016 were down by 3% at EUR 41 (43)
million.
QuikRead(®) infection tests remained the main product, with sales continuing to
increase. With the help of CRP tests from the QuikRead go(®) product family in
infectious disease diagnostics, antibiotic treatment can be targeted at patients
that need it and unnecessary use of antibiotics avoided in situations in which a
patient would not benefit from them. Avoiding unnecessary antibiotic treatments
helps in tackling the growing problem of antibiotic resistance.
Launching of the first Orion GenRead(®) test system products - an instrument and
a C. difficile test for detecting C. difficile bacteria causing intestinal
infection related to antibiotic treatment - continued as planned. The test gives
the first positive C. difficile results already within 20 minutes, which is a
significant advantage in treating a patient. Orion GenRead(®) is based on an
isothermal nucleic acid amplification technique, SIBA(® )technology.
The operating profit of the Diagnostics business was down by 2% at EUR 6.6 (6.8)
million. The operating profit accounted for 16% (16%) of the segment's net
sales.
Espoo, 25 October 2016
Board of Directors of Orion Corporation
Orion Corporation
Timo Lappalainen Jari Karlson
President and CEO CFO
Tables
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
EUR million Q3/16 Q3/15 Change % 9M 2016 9M 2015 Change % 2015
-------------------------------------------------------------------------------
Net sales 258.6 239.1 +8.2% 793.6 754.0 +5.3% 1,015.6
-------------------------------------------------------------------------------
Cost of goods sold -106.8 -105.3 +1.4% -308.5 -291.2 +5.9% -405.8
-------------------------------------------------------------------------------
Gross profit 151.7 133.7 +13.4% 485.1 462.8 +4.8% 609.8
-------------------------------------------------------------------------------
Other operating income
and expenses 22.4 1.1 22.3 0.8 1.5
-------------------------------------------------------------------------------
Sales and marketing
expenses -44.6 -42.8 +4.3% -137.4 -137.6 -0.2% -190.4
-------------------------------------------------------------------------------
R&D expenses -26.9 -23.3 +15.6% -80.3 -76.5 +5.0% -108.1
-------------------------------------------------------------------------------
Administrative
expenses -10.5 -10.2 +3.8% -33.9 -33.8 +0.5% -46.2
-------------------------------------------------------------------------------
Operating profit 92.0 58.6 +57.1% 255.9 215.6 +18.7% 266.6
-------------------------------------------------------------------------------
Finance income 0.2 0.0 +707.0% 0.6 0.6 -1.7% 0.8
-------------------------------------------------------------------------------
Finance expenses -1.2 -1.6 -21.2% -3.7 -4.1 -10.3% -5.5
-------------------------------------------------------------------------------
Share of associated
companies' results 0.4 0.4 -5.2% 0.4
-------------------------------------------------------------------------------
Profit before taxes 91.0 57.0 +59.5% 253.2 212.6 +19.1% 262.3
-------------------------------------------------------------------------------
Income tax expense -18.5 -11.7 +58.1% -51.8 -43.8 +18.1% -54.2
-------------------------------------------------------------------------------
Profit for the period 72.5 45.3 +59.9% 201.5 168.8 +19.4% 208.2
-------------------------------------------------------------------------------
OTHER COMPREHENSIVE INCOME INCLUDING
TAX EFFECTS
-------------------------------------------------------------------------------
Change in value of
cash flow hedges 0.0 0.1 0.1
-------------------------------------------------------------------------------
Change in value of
available-for-sale
financial assets -5.7 -0.2 -5.2 0.8 1.1
-------------------------------------------------------------------------------
Translation
differences -1.4 -1.6 -5.2 1.6 1.8
-------------------------------------------------------------------------------
Items that may be
reclassified
subsequently to profit
and loss -7.1 -1.7 -10.3 2.5 3.0
-------------------------------------------------------------------------------
Items due to
remeasurement of
defined benefit plans -0.0 0.0 -0.0 -0.3 49.1
-------------------------------------------------------------------------------
Items that will not be
reclassified to profit
and loss -0.0 0.0 -0.0 -0.3 49.1
-------------------------------------------------------------------------------
Other comprehensive
income net of tax -7.1 -1.7 -10.4 2.2 52.1
-------------------------------------------------------------------------------
Comprehensive income
for the period
including tax effects 65.4 43.7 +49.8% 191.1 171.0 +11.8% 260.2
-------------------------------------------------------------------------------
PROFIT ATTRIBUTABLE
TO:
-------------------------------------------------------------------------------
Owners of the parent
company 72.5 45.3 +59.9% 201.5 168.8 +19.4% 208.2
-------------------------------------------------------------------------------
Non-controlling
interests 0.0 0.0 0.0 0.0 0.0
-------------------------------------------------------------------------------
COMPREHENSIVE INCOME
ATTRIBUTABLE TO:
-------------------------------------------------------------------------------
Owners of the parent
company 65.4 43.7 +49.8% 191.1 171.0 +11.8% 260.2
-------------------------------------------------------------------------------
Non-controlling
interests 0.0 0.0 0.0 0.0 0.0
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Basic earnings per
share, EUR (1)) 0.52 0.32 +60.3% 1.43 1.20 +19.4% 1.48
-------------------------------------------------------------------------------
Diluted earnings per
share, EUR (1)) 0.52 0.32 +60.3% 1.43 1.20 +19.4% 1.48
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Depreciation,
amortisation and
impairment 10.2 9.9 +2.7% 30.4 31.0 -2.1% 41.8
-------------------------------------------------------------------------------
Personnel expenses 49.2 49.3 -0.2% 162.3 163.3 -0.6% 220.6
-------------------------------------------------------------------------------
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 9/16 9/15 Change % 12/15
-------------------------------------------------------------------------------
Property, plant and equipment 282.0 272.3 +3.6% 276.4
-------------------------------------------------------------------------------
Goodwill 13.5 13.5 13.5
-------------------------------------------------------------------------------
Intangible rights 38.5 42.9 -10.2% 41.7
-------------------------------------------------------------------------------
Other intangible assets 2.5 2.5 -0.9% 2.5
-------------------------------------------------------------------------------
Investments in associates 0.1 2.6 -97.3% 2.6
-------------------------------------------------------------------------------
Available-for-sale financial assets 0.4 6.6 -94.7% 6.9
-------------------------------------------------------------------------------
Pension asset 18.6 24.4
-------------------------------------------------------------------------------
Deferred tax assets 1.1 8.3 -86.5% 1.1
-------------------------------------------------------------------------------
Other non-current assets 3.9 2.9 +32.2% 4.1
-------------------------------------------------------------------------------
Non-current assets total 360.5 351.5 +2.6% 373.3
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Inventories 218.4 189.5 +15.3% 205.7
-------------------------------------------------------------------------------
Trade receivables 185.5 170.5 +8.8% 192.1
-------------------------------------------------------------------------------
Other receivables 35.9 42.3 -15.2% 31.1
-------------------------------------------------------------------------------
Money market investments 20.0
-------------------------------------------------------------------------------
Cash and cash equivalents 178.2 220.2 -19.1% 245.2
-------------------------------------------------------------------------------
Current assets total 638.0 622.5 +2.5% 674.1
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Assets total 998.6 974.0 +2.5% 1,047.4
-------------------------------------------------------------------------------
EQUITY AND LIABILITIES
EUR million 9/16 9/15 Change % 12/15
-------------------------------------------------------------------------------
Share capital 92.2 92.2 92.2
-------------------------------------------------------------------------------
Expendable fund 0.5 0.5 0.5
-------------------------------------------------------------------------------
Other reserves 2.1 6.7 -69.0% 6.9
-------------------------------------------------------------------------------
Retained earnings 494.1 405.7 +21.
Unternehmensinformation / Kurzprofil:
Datum: 25.10.2016 - 11:00 Uhr
Sprache: Deutsch
News-ID 502518
Anzahl Zeichen: 65664
contact information:
Town:
Espoo
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 251 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Orion Group Interim Report January-September 2016"
steht unter der journalistisch-redaktionellen Verantwortung von
Orion Oyj (Nachricht senden)
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