03.09.2013 18:17:00

bioMérieux - First-Half 2013 Results

Regulatory News:

The Board of Directors of bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, met on August 30 to approve the consolidated financial statements for the six months ended June 30, 2013. The meeting was chaired by Jean-Luc Belingard and attended by the Statutory Auditors, who had performed a limited review of the financial statements.

Consolidated Data

In € millions

  Six Months Ended

June 30, 2013

  Six Months Ended

June 30, 2012

  % Change

As Reported

Sales   754   750   + 0.5%
Operating income before non-recurring items 125 128 - 2.0%
Operating income 124 125 - 0.6%
Net income of consolidated companies 80 80 + 0.5%

EBITDA*

  169   172   - 1.7%

*Operating income before non-recurring items, depreciation and amortization

"In the first half, bioMérieux stepped up its investments in innovation and pursued its international expansion,” said Jean-Luc Belingard, Chairman and Chief Executive Officer. "In particular, we began installing VIDAS® 3 systems in late June and continued to prepare for the commercial deployment of our two new clinical microbiology platforms. We saw double-digit growth in emerging markets. In this context of strong investments, the stability of our interim earnings attests to the financial discipline being applied in every level of our organization. Based on these achievements, we are reaffirming our full-year 2013 targets.”

SIGNIFICANT EVENTS OF FIRST-HALF 2013

  • Commercial offer

In the first half of the year, bioMérieux enhanced its portfolio of solutions by launching 11 new products.

  • In clinical applications, the Company was awarded the following marketing approvals, among others:
    VIDAS® 3, the new generation VIDAS®, was CE marked. Featuring enhanced automation, improved traceability and new software capabilities, as well as a quality control program in compliance with laboratory certification standards, the new instrument is now commercially available in Europe and the countries that recognize the CE marking. The Company expects to gradually obtain regulatory approval for sale in other countries, particularly the United States and China.
    The new bioMérieux’s THxIDTM-BRAF real-time PCR molecular test has received pre-market approval (PMA) from the U.S. Food and Drug Administration for commercialization in the United States. This companion diagnostic test will help clinicians choose an appropriate treatment for advanced melanoma. It is intended for patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s (GSK) Tafinlar® (dabrafenib), as well as patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist™ (trametinib).
    The Company also received clearance from the U.S. Food and Drug Administration to market ARGENE’s Adenovirus R-gene™ test in the United States. This PCR test enables the qualitative detection of adenovirus DNA in real time. Adenovirus infections are common, have a worldwide distribution and can cause respiratory, ocular or gastrointestinal diseases that are recognized as dangerous for immunocompromised patients.
  • In industrial applications, bioMérieux was also granted major product approvals, including in particular:
    VIDAS® UP Listeria (LPT) and VIDAS® Listeria monocytogenes xpress (LMX) were awarded Official Methods of Analysis approval by AOAC International. This unprecedented AOAC Expert Review Panel (ERP) approval of two tests simultaneously highlights the reliability and significance of this complete screening solution for Listeria, a pathogenic bacteria that is widespread in the environment and can be found in food products.
    The VIDAS® UP Salmonella (SPT) test was granted Official Methods of Analysis approval by AOAC International for a wide variety of food products and environmental samples. Salmonella is a bacteria that causes salmonellosis, one of the most common intestinal infections worldwide. The VIDAS® UP Salmonella (SPT) solution uses recombinant phage protein-based technology that ensures best-in-class specificity and sensitivity. Easy to use, VIDAS® UP Salmonella SPT enables the capture and targeted detection of Salmonella in less than 24 hours.
    bioMérieux introduced the TEMPO® Aerobic Count (TEMPO® AC) test that enumerates total bacterial flora in food and environmental samples in as little as 24 hours. This latest generation TEMPO® test, which is faster and less sensitive to the highly varied characteristics of food samples, has already won over new customers in the United States. Prior to commercial launch, it obtained the AOAC RI (Research Institute) validation.
  • Innovation

Innovation is at the heart of the Company’s strategy.

  • R&D expenditure is currently being focused on bringing the new instruments to market. In line with its launch schedule, the new incubator incorporating imaging technologies was presented to microbiology laboratories at ECCMID2 2013, held in late April in Berlin. During the Congress, bioMérieux also revealed the tradename of its new blood culture instrument, known as Virtuo™.
  • Veolia Environnement and bioMérieux have announced their commitment to undertaking a research partnership aimed at developing an innovative technology for the continuous monitoring of the microbiological quality of drinking water. An agreement covering a preliminary study to assess the project’s technical and economic feasibility was signed in March 2013.
  • In late June, more than 70 world-renowned experts in the field of antimicrobial resistance and healthcare-associated infections met in Annecy for the 4th Edition of the World HAI Forum3, organized by bioMérieux.
  • Manufacturing operations
  • The Durham, NC site (United States)
    The Company is continuing to work to improve its BacT/ALERT® blood culture bottle production lines in Durham, in order to restore satisfactory supply levels and to strengthen its management quality process. This is generating major additional operating costs. Moreover, inspectors from the U.S. Food and Drug Administration re-inspected the site in June to verify effective deployment of the Company’s action plan to remediate observations contained in the August 2012 Warning Letter and to perform additional quality system reviews.
  • Deployment of the Global ERP system
    The Global ERP system continued to be successfully deployed during the period. Following launch in South Korea and Japan, it is now up and running in 16 subsidiaries.
  • New Management Committee organization

After more than 30 years with bioMérieux, Henri Thomasson, Chief Financial Officer, has decided to retire. In addition, Steve Harbin, Corporate Vice President, Manufacturing and Supply Operations, Quality Management, Regulatory Affairs & Information Systems, has decided to embark on a new career as an entrepreneur. Jean-Luc Belingard, Chairman and Chief Executive Officer of bioMérieux, the Board of Directors and the members of the Management Committee thank Henri Thomasson and Steve Harbin for the significant contribution they have made and momentum they have given to the Company’s development.

As a result, the Management Committee is now organized as follows:

  • Alexandre Mérieux, Directeur Général Délégué of the Company, leads Manufacturing Operations and Supply Chain. In addition, Alexandre Mérieux continues to be Corporate Vice President of the Microbiology and Molecular Biology unit. His team includes more than 2,000 employees worldwide.
  • François Lacoste, Corporate Vice President of the Immunoassay Unit, is also in charge of the Quality.
  • Mark Miller, Chief Medical Officer, also oversees Regulatory Affairs.
  • Effective September 5, Claire Giraut will join bioMérieux’s Management Committee. She will begin as Head of the Information Systems (IS) and Purchasing Departments. After a transition period with Henri Thomasson, she will assume responsibility for the new Administration and Finance Department, enlarged to Purchasing and IS. Before joining bioMérieux, Claire Giraut held various positions as Chief Financial Officer. Her latest assignments were with Ipsen and Europcar Groupe. She is a graduate of the Institut National Agronomique Paris-Grignon.

FINANCIAL RESULTS

Sales4

After remaining stable in the first three months of the year, sales rose by 4% at constant exchange rates and scope of consolidation in the second quarter, led by rapid growth in emerging markets and in industrial applications.

As a result, sales ended the first half at €754 million, versus €750 million a year earlier, for a 2.1% increase at constant exchange rates and scope of consolidation.

Sales varied by region during the period. In Western Europe, markets remained generally difficult, while in North America, sales recovered as the Group’s product offering in critical care and ICUs, as well as in industrial applications, helped to drive growth. Emerging markets expanded at a rapid pace, stimulated by ambitious government measures and vigorous demand from laboratories. As a result, they accounted for 29% of consolidated sales and delivered an organic gain of 11%, further attesting to their role as a major growth driver.

Sales by Region

In € millions

  Six Months

Ended

June 30, 2013

  Six Months

Ended

June 30, 2012

  % Change

As reported

 

Variation

At constant exchange
rates & scope of
consolidation

Europe (1)   391   395   - 1.0%   - 0.7%
North America 168 167 + 0.5% + 1.9%
Asia-Pacific 131 126 +4.3% + 8.7%
Latin America   64   62   + 2.3%   + 7.3%
TOTAL   754   750   + 0.5%   + 2.1%

(1) Including the Middle East and Africa

bioMérieux is uniquely positioned in the in vitro diagnostics market thanks to its leadership in clinical and industrial microbiology, two segments that account for more than 70% of its sales.

In the clinical segment, growth during the period was driven by sales of reagents in the three strategic lines (microbiology, VIDAS® and molecular biology). In particular, the microbiology business saw a satisfactory 4% increase in reagent sales, while instrument sales remained weak. Sales of industrial applications rose by 4.5% over the period, benefiting from their global positioning and extensive product line-up combining automated solutions and manual tests.

Sales by Technology

In € millions

  Six Months

Ended

June 30, 2013

  Six Months

Ended

June 30, 2012

  % Change

As reported

 

Variation

At constant exchange
rates & scope of
consolidation

Clinical Applications   597   597   0.0%   + 1.5%
Microbiology 377 379 - 0.4% + 1.5%
Immunoassays 175 176 - 0.4% + 0.9%
Molecular Biology 37 34 + 6.6% + 7.3%
Other Lines 8 8 + 0.5% - 7.0%
Industrial Applications   157   153   + 2.3%   + 4.5%
TOTAL   754   750   + 0.5%   + 2.1%

Consolidated income statement

  • Gross profit was stable for the period, at €397 million versus €393 million in first-half 2012. The Company is encountering difficulties in its blood culture bottle production operations, is deploying an action plan to enhance quality management at the Durham, NC site and is seeing an increase in transportation costs due to the shift in its geographic business base. On the upside, gross profit was lifted by the increased proportion of reagents and services in the consolidated sales mix, the reduction in acquisition accounting expenses concerning AES and ARGENE, and the favorable currency effect. As a result, gross margin stood at 52.6% of sales, versus 52.4% in first-half 2012.
  • Operating income before non-recurring items5 came to €125 million, compared with €128 million

in first-half 2012, and represented 16.6% of sales.

  • Attesting to the Company’s strict cost discipline, selling, general and administrative expenses slightly underpaced sales growth, ending the period at 26.3% of sales versus 26.4% a year earlier.
  • To prepare for the launch of its new platforms, the Company allocated 11.7% of sales to research & development, raising its R&D investments by more than 12% at constant exchange rates. In all, R&D expenses totaled €88 million for the period, versus €79 million in first-half 2012.
  • Research tax credits recognized during the period amounted to €11.4 million, compared
    with €8.5 million in first-half 2012.
  • Operating income was almost unchanged, at €124 million, after €1.3 million in net non-recurring expense, versus €3.1 million in first-half 2012.
  • Net financial expense amounted to €4.7 million, unchanged from first-half 2012.
  • Given the near-stability in operating income, income tax expense was on a par with first-half 2012. It represents 32.6% of pretax income.
  • Together, these factors helped to hold net income steady at €80 million (€2.02 per share) or 10.6% of sales.

Consolidated cash flow statement

  • With operating income before non-recurring items and depreciation and amortization expense both stable year-on-year, EBITDA6 was maintained virtually unchanged at €169 million, compared with €172 million in first-half 2012.
  • Operating working capital requirement rose by €55 million.
  • The net value of inventory increased by €36 million (versus €21 million at June 30, 2012) due to the build-up of safety stocks and the preparation for the market launch of the VIDAS® 3 platform.
  • Effective management of trade receivables reduced customer receivables by €14 million during the period. In first-half 2012, they had been lowered by €31 million, when Spanish provincial authorities paid €28.5 million in late June, thereby settling almost all of the pre-2012 public hospital receivables. In 2013, Spanish authorities announced a similar payment, which would settle all of the receivables due as of end-May (around €12 million). At June 30, 2013, net receivables due from Greek, Portuguese, Spanish and Italian public-sector customers totaled €75 million, unchanged
    from December 31, 2012 and compared with €100 million at December 31, 2011. Across the entire customer base, average days sales outstanding stood at 100 days, versus 103 days as of June 30, 2012.
  • Based on these factors, operating working capital requirement represented 28.6% of sales, compared with 25.9% at June 30, 2012 (27.8% before the payment from Spanish provincial authorities).
  • Capital expenditure outlays totaled €60 million, compared with €54 million in first-half 2012, including €46 million in industrial capital expenditure versus €38 million in first-half 2012. The latter primarily concerned the ongoing improvement at certain production sites and R&D facilities, capacity extension projects, mainly at the Durham, Craponne and Marcy L’Etoile sites, and the Global ERP system.
  • Based on the above, free cash flow before dividends, acquisitions and divestments stood at €42 million for the period, versus €69 million in first-half 2012, when it was lifted by the one-time €28.5 million payment from the Spanish provincial authorities.
  • In June 2013, the Company paid a dividend of €0.98 per share, for an aggregate payout of €38.7 million, unchanged from 2012.
  • As a result, net debt amounted to €43 million at June 30, 2013, versus €94 million a year earlier and €48 million at December 31, 2012.

Other financial highlights

  • The installed base at June 30, 2013 stood at approximately 71,000 instruments, an increase of 1,600 new instruments over the period.

Human resources

  • The Company had 7,623 full-time-equivalent employees as of June 30, 2013. There were 7,413 employees at December 31, 2012, based on the same method of calculation.

SUBSEQUENT EVENTS

  • BioFire Diagnostics, Inc.: a major acquisition in molecular biology in the United States

bioMérieux today announced that it has entered into an agreement to acquire7 the privately held U.S. molecular biology company BioFire, which invented, manufactures and markets the FilmArray® system, a rapid, easy-to-use multiplex PCR molecular biology solution. FilmArray® makes it possible to take a syndromic approach to infectious diseases, a novel method of medical diagnosis based on analyzing a syndrome (i.e. a set of symptoms) in order to identify, in a single reagent, its associated viral or bacterial pathogens. In addition, bioMérieux intends to review, with its partner Biocartis, its role in their joint project, Apollo. As soon as the transaction closes, BioFire’s integration will enable bioMérieux to increase the proportion of sales derived from molecular biology to 8% and to consolidate its position as a major player in infectious disease diagnostics, its core strategic focus. With a complete range of technologies for clinical microbiology diagnostics, bioMérieux will also reinforce its leadership in microbiology.

  • Partnership with Philips in automated Point-of-Care

In January 2010, Philips and bioMérieux began collaborating to jointly develop fully automated handheld diagnostic testing solutions for hospital use that can be deployed at the point-of-care – i.e. close to the patient. Given the challenges encountered in developing Troponin solutions delivering performance comparable to central laboratory analyzers, both partners have signed an addendum to the original agreement. It provides that Philips will separately pursue development of the Troponin assay and system. bioMérieux will discontinue its own assay development during this development period, but provide an undisclosed level of funding toward the development. In addition, this addendum maintains bioMérieux’s rights to re-engage on a non-exclusive basis, until March 31, 2014.

  • FDA clearance for the VITEK® MS mass spectrometry solution for microbial identification

In August, bioMérieux was granted 510(k) de novo clearance by the U.S. Food and Drug Administration for its VITEK® MS platform, which is now the first clinical mass spectrometry MALDI-TOF-based system commercially available in the United States for the rapid identification of disease-causing bacteria and yeast. The latest addition to the VITEK® family of products, VITEK® MS is the first system to enable detection of disease-causing microorganisms in minutes.

2013 OBJECTIVES

In 2013, bioMérieux expects to report sales growth of between 3% and 5% for the year, at constant exchange rates and scope of consolidation. In an especially demanding economic environment, notably in Western Europe, the Company will benefit from the resilience of its business model and the technological and geographic diversification of its business base.

In addition, bioMérieux confirms its full-year objective for operating income before non-recurring items of between €255 million and €270 million.

INVESTOR CALENDAR

Third-quarter 2013 sales: October 23, 2013, before start of trading

The above forward-looking statements are based, entirely or partially, on assessments or judgments that may change or be modified, due to uncertainties and risks related to the Company's economic, financial, regulatory and competitive environment, notably those described in the 2012 Registration Document. Accordingly, the Company cannot give any assurance nor make any representation as to whether the objectives will be met. The Company does not undertake to update or otherwise revise any forecasts or objectives presented herein, except in compliance with the disclosure obligations applicable to companies whose shares are listed on a stock exchange.

ABOUT BIOMERIEUX

Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 41 subsidiaries and a large network of distributors. In 2012, revenues reached €1,570 million with 87% of sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).
Corporate website: www.biomerieux.com. Investor website: www.biomerieux-finance.com.

1 At constant exchange rates and scope of consolidation
2 European Congress of Clinical Microbiology and Infectious Diseases
3 World Forum on Healthcare-Associated Infections and Antimicrobial Resistance
4 The first-half 2013 business review may be found on www.biomerieux-finance.com
5 Operating income before "material, extraordinary and non-recurring items”, which are included in "other non-recurring operating income and expenses”
6 Operating income before non-recurring items, depreciation and amortization
7 The press release may be found on www.biomerieux-finance.com

bioMérieux

CONSOLIDATED INCOME STATEMENT

In millions of euros   JAN 13

JUN 13

6 months

  JAN 13

DEC 12

12 months

  JAN 12

JUN 12

6 months

Net Sales   754,2   1 569,8   750,4
Cost of sales   -357,7   -755,6   -357,3
Gross profit   396,5   814,2   393,1
Other operating income   15,4   23,9   11,4
Selling and marketing expenses   -140,5   -294,7   -144,0
General and administrative expenses -58,0 -114,3 -54,0
Research and development expenses -88,3 -168,7 -78,9
Total operating expenses   -286,8   -577,7   -276,9
Operating income before non-recurring items   125,1   260,4   127,6
Other non-recurring income (expenses)   -1,3   -25,4   -3,1
Operating income   123,8   235,0   124,5
Cost of net financial debt -1,1 -6,4 -3,8
Other financial items -3,6 -4,9 -1,0
Income tax -38,9 -89,4 -40,0
Investments in associates   -0,2   0,0   0,0

Net income of consolidated companies (a)

  80,0   134,2   79,6
Attributable to the minority interests   0,3   -0,1   0,5
Attributable to the parent company   79,7   134,4   79,1
Basic net income per share   2,02   3,41   2,01
Diluted net income per share   2,02   3,41   2,01

(a) Revised IAS 19 standard has no relevant impact on December 2012 and June 2012 accounts

bioMérieux

CONSOLIDATED BALANCE SHEET

ASSETS NET   NET NET
In millions of euros 12/31/2012

12/31/2012 (a)

 

12/31/2011 (a)

NON-CURRENT ASSETS
. Intangible assets 155,5 157,0 186,5
. Goodwill 309,5 313,1 334,3
. Property, plant and equipment 385,8 386,7 366,3
. Financial assets 32,0 34,7 25,2
. Investments in associates 0,2 0,0 0,0
. Other non-current assets 26,6 29,6 31,0
. Deferred tax assets 34,2 42,2 42,4
TOTAL 943,7 963,4 985,8
CURRENT ASSETS
. Inventories and work in progress 278,5 245,9 240,3
. Accounts receivable 410,9 433,4 420,4
. Other operating receivables 85,9 71,2 69,2
. Tax receivable 4,7 20,7 11,4
. Non-operating receivables 8,7 8,4 1,3
. Cash and cash equivalents 58,5 65,6 85,6
 
TOTAL 847,2 845,4 828,2
 
. Assets held for sale 49,4 45,7 12,0
 
TOTAL ASSETS 1 840,4   1 854,4   1 826,1
LIABILITIES AND SHAREHOLDERS' EQUITY 12/31/2012   12/31/2012 (a) 12/31/2011
SHAREHOLDERS' EQUITY
. Share capital 12,0 12,0 12,0
. Additional paid-in capital & Reserves 1 106,1 1 007,0 1 023,3
. Net income for the year 79,7 134,4 79,1
TOTAL EQUITY BEFORE MINORITY INTERESTS 1 197,9 1 153,4 1 114,5
MINORITY INTERESTS 7,1 6,8 8,5
TOTAL SHAREHOLDERS' EQUITY 1 205,0 1 160,2 1 123,0
NON-CURRENT LIABILITIES
. Net financial debt - long-term 7,6 9,8 13,5
. Deferred tax liabilities 39,5 46,3 38,0
. Provisions 86,8 103,0 93,4
TOTAL 133,9 159,1 144,9
CURRENT LIABILITIES
. Net financial debt - short-term 93,7 104,2 165,9
. Provisions 12,7 11,0 10,7
. Accounts payable 125,8 145,1 134,7
. Other operating liabilities 217,6 217,9 207,0
. Tax liabilities 29,0 20,2 23,7
. Non-operating liabilities 9,2 23,8 16,1
TOTAL 487,9 522,2 558,1
. Liabilities related to assets held for sale 13,6 13,0 0,0
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 1 840,4 1 854,4 1 826,1

(a)Including retrospective application of IAS 19R

bioMérieux

CASH FLOW STATEMENT

CASH FLOW STATEMENT

In millions euros

  Jan 13

Jun 13

6 months

  Jan 12

Dec 12

12 months

  Jan 12

Jun 12

6 months

Net income of consolidated companies   80,0   134,2   79,6
Adjustements
- Investments in associates 0,2 0,0 0,0
- Cost of net financial debt 1,1 6,4 3,8
- Other financial items 3,6 4,9 1,0
- Current income tax expense 38,9 89,4 40,0
- Operating depreciation and provisions on assets 43,9 94,4 44,6
- Non-recurring items 1,3 25,4 3,1
EBITDA (before non-recurring items) 169,0 354,8 172,1
Other non current operating gains/losses

(w/o exceptionnal depreciations, assets losses and capital gains/losses)

-0,9 -2,9 -0,5
Other financial items

(w/o accruals & disposal of financial assets)

-1,2 -0,5 -0,7
Operating provisions for risks and contingencies 5,3 8,0 2,6
Change in fair value of financial instruments -0,6 -0,4 -0,3
Share-based payments 0,4 -2,5 -2,1
Elimination of other gains and losses without any impact on cash or operations 3,0 1,7 -1,0
Increase in inventories -35,6 -32,0 -21,4
Decrease of requirements in accounts receivable 14,0 6,5 30,7
Decrease in accounts payable -18,9 6,0 -9,0
Increase of other operating working capital -14,5 -6,7 -11,6
Increase in operating working capital -55,0 -26,2 -11,3
Other non operating working capital -0,3 3,0 -4,9
Change in non-current assets 3,1 1,4 1,3
Other cash flows from operation -52,2 -21,8 -14,9
Income tax paid   -18,1   -76,2   -35,1
Net cash flow from operations   101,7   258,5   121,1
Purchase of property, plant and equipment -59,6 -127,4 -53,6
Proceeds on fixed asset disposals 1,7 8,2 4,1
Purchase of financial assets / Disposals of financial assets -0,2 -12,9 0,3
Impact of changes in the scope of consolidation   0,0   1,7   3,5
Net cash flow from (used in) investment activities   -58,1   -130,4   -45,7
Purchases and proceeds of treasury stocks -0,4 0,8 0,4
Dividends to shareholders -38,7 -38,7 -38,7
Dividends to minority interests 0,0 -0,5 0,0
Cost of net financial debt -1,1 -6,4 -3,8
Change in confirmed financial debt   -8,1   -11,4   38,7
Net cash flow from (used in) financing activities   -48,3   -56,2   -3,3
             
NET CHANGE IN CASH AND CASH EQUIVALENTS   -4,7   71,9   72,1
ANALYSIS OF NET CHANGE IN CASH AND CASH EQUIVALENTS
Net cash and cash equivalents at the beginning of the year 52,5 -19,2 -19,2
Impact of currency changes on net cash and cash equivalents 1,0 -0,2 4,1
Net change in cash and cash equivalents   -4,7   71,9   72,1
Net cash and cash equivalents at the end of the year   48,8   52,5   57,0

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