- Robust growth in nine-month
sales:
- Sales reached €1,412 million
- Up 18.3% as reported
- Up 8.3% at constant exchange rates and
scope of consolidation
- Solid momentum in the Americas and
EMEA1 regions in the third quarter
- Significant operational
advances:
- FDA clearance of the 4th FilmArray®
panel: Meningitis/Encephalitis
- Commercial launch of VIDAS® 3 in the
United States
- Deployment of capital expenditures as
planned
- Organic sales growth objective
should end the year around 6.5%
Alexandre Mérieux, Chief Executive Officer,
said: "bioMérieux continued to drive very satisfactory organic
sales growth over the first nine months of the year, with a more
than 8% gain for the period. This sales performance reflects our
effectively balanced product portfolio and geographic positions, as
well as FilmArray®’s remarkable performance. Given this robust
growth dynamic and based on our nine-month sales, organic sales
growth objective should end the year around 6.5%."
Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro
diagnostics, today released its business review for the nine months
ended September 30, 2015.
SALES
Consolidated sales rose to €1,412 million in the first nine
months of 2015 from €1,193 million in the year-earlier period,
an increase of 18.3% as reported and of 8.3% at constant exchange
rates and scope of consolidation. After nine months of operations,
bioMérieux growth excluding BioFire reached 4.5% year-on-year.
BioFire contributes by around 400 basis points to the Group’s
growth.
Analysis of
sales
In € millions
Sales - Nine months ended September 30, 2014
1,193 Currency effect +111 +9.3% Organic growth (at
constant exchange rates and scope of consolidation) +99 +8.3% +9.0%
Changes in scope of consolidation(1) +9 +0.7%
Sales - Nine
months ended September 30, 2015 1,412 +18.3%
(1) BioFire: sales from January 1 to January 15, 2015 excluded
from the organic growth calculation (acquisition date:
January 16, 2014)CEERAM: first-time consolidation of
sales from this technological start-up acquired in late December
2014.
1 Europe – Middle East – AfricaNB:
unless otherwise stated, growth is expressed year-on-year at
constant exchange rates and scope of consolidation
(like-for-like).
Third-quarter sales stood at €478 million, an 8.8% year-on-year
organic increase that was led by a remarkable performance in North
America and the firm momentum in the Eastern Europe – Middle East –
Africa region.
Growth during the third quarter fully benefited from the broad
portfolio of technologies, particularly FilmArray®, which saw a
sharp rise in North American sales, and the VIDAS® and VITEK®
lines, which turned in a solid performance.
Sales for the first nine months and the third quarter of 2015
may be summarized by region as
follows:
Sales by Region
In € millions
9 monthsended Sep
30,
2015
9 monthsendedSep 30,2014
% changeas reported
% changeat constantexchangerates
andscope ofconsolidation
Q32015
Q32014
% changeas reported
% changeat constantexchangerates
andscope ofconsolidation
Europe (1)
618.8 595.4 +3.9%
+2.8% 203.8 192.9 +5.6%
+4.9% Americas
544.3 392.1 +38.8%
+18.0%
186.0 142.4 +30.6%
+16.5% North America
443.5
299.2 +48.2%
+20.6% 151.7 108.4 +39.9%
+18.4%
Latin America
100.8 92.9 +8.5%
+9.6% 34.2 33.9
+1.0%
+10.3% Asia-Pacific
229.9 193.5
+18.8%
+4.4% 81.1 73.1
+10.9%
+0.6% Total sales from the regions
1,393.0 1,181.0 +18.0%
+8.1% 470.9 408.5 +15.3%
+8.1% bioTheranostics
14.0 7.0
+99.4%
+63.9% 5.1 2.3 +118.2%
+83.0% R&D-related revenues
4.5
4.7
2.3 1.2
TOTAL 1,411.5
1,192.7 +18.3%
+8.3% 478.3 412.0
+16.1%
+8.8%
(1) Including the Middle East and
Africa.
- Sales in the Europe – Middle East –
Africa region (44% of the consolidated total) came to
€619 million for the period, up 2.8% year-on-year.
- In Western Europe (38% of the
consolidated total), nine-month sales were 1.3% higher compared
with the year before. In the third quarter, sales rose by more than
5% year-on-year in Southern Europe, lifted by the good performance
in Spain and Portugal. Growth in Northern and Central Europe
continued to be driven by the solid results in Germany, the United
Kingdom and the Scandinavian countries, while the slowdown in
French sales leveled off in a persistently difficult market
environment.
- Sales surged 12% in the Eastern
Europe – Middle East – Africa region which is still
significantly hindered by geopolitical tensions, boosted by a firm
performance across every country, as well as by a favorable
comparison in the third quarter. Third-quarter sales were lifted by
a number of one-off tender wins, notably in Lebanon.
- The pace of growth remained very strong
in the Americas during the third quarter, with nine-month
sales climbing nearly 18% year-on-year to €544 million.
- In North America (32% of the
consolidated total), sales rose by 20.6% year-on-year, led by the
remarkable performance of FilmArray® and the solid growth in sales
of VIDAS® B•R•A•H•M•S PCT™ tests and of the VITEK® bacterial
identification and antibiotic susceptibility testing lines.
Industrial application sales were lifted by sustained demand for
the bacterial flora detection and enumeration lines.
- Third quarter sales in Latin
America (7% of the consolidated total) were up 10.3%
year-on-year, with solid gains by every subsidiary except in
Brazil, where economic difficulties are still weighing on
demand.
- In the Asia-Pacific region (17%
of the consolidated total), sales came to €230 million for the
period, up 4.4% year-on-year.
- Sales in China retreated 2% in
the third quarter as sustained growth in reagent sales failed to
offset the sharp slowdown in instrument sales during the period, in
both clinical and industrial applications (except for VIDAS®). Next
quarter should show an unfavorable basis effect due to
significantly higher instrument sales during fourth quarter
2014.
- In the rest of the region, the
third-quarter situation varied by country, with sales rising by
more than 20% in India but edging back by almost 2% in Japan and
South Korea on the same period.
Sales for the first nine months and the third quarter of 2015
may be summarized by application as
follows:
Sales by Application
In € millions
9 months endedSep 30,
2015
9 monthsendedSep 30,2014
% changeas reported
% changeat constantexchangerates
andscope ofconsolidation
Q3 2015
Q32014
% changeas reported
% changeat constantexchangerates
andscope ofconsolidation
Clinical Applications 1,114.8 940.9
+18.5%
+8.4% 374.3 325.3
+15.0%
+7.9% Microbiology
632.5 564.2 +12.1%
+4.3% 216.2 199.3 +8.2%
+3.0% Immunoassays(1)
315.9 276.3 +14.3%
+6.1% 105.7 91.3 +15.7%
+9.0% Molecular Biology(2)
158.1 89.1 +77.4%
+46.1% 50.2 31.4 +59.9%
+31.7% Other
8.3 11.3 -25.2%
-28.0% 2.2 3.3 -31.7%
-35.5% Industrial Applications 260.3 233.6
+11.4%
+3.7% 87.5 81.0 +7.9%
+2.4%
bioTheranostics
14.0 7.0 +99.4%
+63.9% 5.1 2.5
x 2.2
+83.0% BioFire Defense
17.9 6.5 x 2.7
x
2.2 9.1 2.1 x 4.4
x 3.7 R&D-related revenue
4.5 4.7
2.3
1.2
TOTAL
1,411.5 1,192.7 +18.3%
+8.3%
478.3 412.0 +16.1%
+8.8%
( 1) Including VIDAS®: up 9.1% over the first nine months and
12.4% in the third quarter, at constant exchange rates and scope of
consolidation.(2) Including BioFire Diagnostics sales: €97 million
over the first nine months and €30 million in the third
quarter.
- Sales of clinical applications
rose by 8.4% year-on-year to €1,115 million.
- Microbiology sales stood at €633
million for the first nine months, up 4.3% primarily on the firm
demand for culture media and the VITEK® automated ID/AST line of
instruments and reagents. Sales of the BacT/ALERT® and VIRTUO™
blood culture lines cooled somewhat in the third quarter due to an
unfavorable comparison with the prior-year period, when the return
to normal production conditions at the Durham (NC - United-States)
site made it possible to rebuild part of the customer safety stock
inventory.
- In immunoassays, VIDAS® sales
climbed 9.1% year-on-year. In the third quarter, reagents enjoyed
double-digit growth in the Americas and Asia-Pacific regions. In
particular, high medical value tests, such as the VIDAS®
B•R•A•H•M•S PCT™ test, are still driving the line's expansion,
thereby confirming the successful repositioning of VIDAS® in
clinical biology labs. In addition, instrument sales showed signs
of an upturn in the Asia-Pacific region.
- Molecular biology sales amounted
to €158 million for the period, an increase of nearly 50%
year-on-year. The FilmArray® line again turned in a remarkable
performance in the third quarter, with cumulative nine-month sales
up by about 100% from the prior-year period. The other molecular
biology lines showed positive momentum, notably with 13% growth in
the ARGENE® range of solutions for the management of viral
infections in immunocompromised patients.
- Industrial application sales,
which represent 18% of the consolidated total, rose by 3.7% to
€260 million in the first nine months of 2015. All of the
regions contributed to this growth, especially North America.
Demand from the agri-foods and pharmaceutical industry improved in
the third quarter, particularly for the bacterial flora enumeration
technologies (CHEMUNEX® and TEMPO®).
- Organic growth in sales of
reagents and services, which accounted for 91% of the
consolidated total, came to 8.4% for the first nine months.
OTHER INFORMATION
Net debt amounted to €236 million at September 30, 2015,
versus €249 million at December 31, 2014.
THIRD-QUARTER OPERATING HIGHLIGHTS
- Production and quality
system
In June 2015, the US Food and Drug Administration (FDA)
re-inspected the St. Louis, MO site and reviewed all of the
corrective actions implemented in response to the October 2014
Warning Letter. It determined that there were no repeat
observations as regards the Letter. Based on this evaluation, on
September 18, the agency issued a Close-Out Letter confirming that
its remarks and warnings issued in 2014 had been addressed and
encouraging bioMérieux to maintain its efforts to ensure sustained
compliance in its operations.
The facilities in Craponne, France and Durham, NC continued to
deploy the action plans defined respectively with France's ANSM
drug regulatory agency and the FDA to address their
observations.
- VIDAS 3 cleared by the FDA and
introduced in the United States
On July 9, bioMérieux received 510(k) clearance from the FDA to
market VIDAS® 3 in the United States. Launched at the American
Association for Clinical Chemistry (AACC) Clinical Lab Expo, the
new generation VIDAS® has received an enthusiastic reception from
customers, who appreciate its ease of use, enhanced automation,
improved traceability and greater optimization of laboratory
workflows.
SUBSEQUENT EVENTS
- FDA clearance received for the
FilmArray® Meningitis/Encephalitis Panel
On October 8, the FilmArray® Meningitis/Encephalitis (ME) Panel
received de novo clearance from the FDA. With its unique medical
value, this panel is the first test to address a critical unmet
need for quick and accurate identification of central nervous
system infectious agents by utilizing a comprehensive panel to test
cerebrospinal fluid (CSF) for the 14 most common pathogens (six
bacteria, seven viruses and one yeast) responsible for
community acquired meningitis or encephalitis in about an hour. The
FilmArray® ME Panel should be commercially available in the United
States in November and CE-marked shortly after. It can be run on
the FilmArray® and FilmArray® 2.0 multiplex PCR systems.
2015 OBJECTIVES
Based on the sales performance for the first nine months of the
year, and assuming a flu epidemic of average intensity, bioMérieux
is raising its full-year organic growth objective to around
6.5%, at constant exchange rates and scope of consolidation. The
Company is also pursuing its strategy of innovation and geographic
expansion, and actively supporting the launch of its new products,
such as VIRTUO™ and FilmArray®. Against this backdrop, bioMérieux
confirms the previously announced objective of achieving
contributive operating income of between €240 million and
€265 million.
INVESTOR CALENDAR
Fourth-quarter sales: January 17, 2016, 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 2014 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 BIOMÉRIEUX
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for 50
years, bioMérieux is present in more than 150 countries
through 42 subsidiaries and a large network of distributors. In
2014, revenues reached €1,698 million with 88% 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 stock market
(Symbol: BIM – ISIN: FR0010096479).
Corporate website: www.biomerieux.com
Investor website: www.biomerieux-finance.com
APPENDIX: QUARTERLY SALES DATA
Sales by Region - in € millions First quarter
Second quarter Third quarter 2015 2014
2015 2014 2015 2014 Europe(1) 204.0
193.9 210.9 208.5 203.8 192.9
Americas 176.5 119.6 181.8 130.2 186.0 142.4 North America 144.7
93.4 147.0 97.4 151.7 108.4 Latin America 31.8 26.2 34.8 32.8 34.2
33.9 Asia-Pacific 61.9 53.5 86.9 66.9
81.1 73.1 Total sales from the regions 442.4
367.0 479.6 405.6 470.9 408.5
bioTheranostics 4.1 2.1 4.8 2.5
5.1 2.3 R&D-related revenues 1.4 1.7
0.8 1.8 2.3 1.2 TOTAL 447.9
370.8 485.3 409.9 478.3 412.0
(1) Including the Middle East and Africa.
% Change in Sales by Region First quarter
Second quarter Third quarter As reported
At constantexchangerates andscope
ofconsolidation
As reported
At constantexchangerates andscope
ofconsolidation
As reported
At constantexchangerates andscope
ofconsolidation
Europe(1) +5.2% +3.9% +1.1% -0.3% +5.6%
+4.9% Americas +47.7% +19.6% +39.7% +18.2% +30.6% +16.5%
North America +55.1% +21.0% +50.9% +22.6% +39.9% +18.4% Latin
America +21.1% +14.8% +6.2% +4.8% +1.0% +10.3% Asia-Pacific
+15.7% +0.8% +29.9% +11.3% +10.9%
+0.6% Total sales from the regions +20.5%
+8.6% +18.3% +7.6% +15.3% +8.1%
bioTheranostics +90.1% +56.6% +96.3%
+53.3% +118.2% +83.0% R&D-related revenues
TOTAL +20.8% +8.7% +18.4%
+7.6% +16.1% +8.8%
(1) Including the Middle East and Africa.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151021006601/en/
Investor RelationsbioMérieuxSylvain Morgeau, +33
(0)4 78 87 22 37investor.relations@biomerieux.comorMedia
RelationsbioMérieuxAurore Sergeant, +33 (0)4 78 87 54
75media@biomerieux.comorImage SeptLaurence Heilbronn, +33
(0)1 53 70 74 64lheilbronn@image7.frorClaire Doligez, +33 (0)1 53
70 74 48cdoligez@image7.fr
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