- 10.3% organic sales growth for the
first nine months of 2016, powered by the Americas and Asia-Pacific
regions:
- Sales reached €1,512 million
- Up 7.1% as reported
- All strategic lines contributed to
the dynamic performance
- FilmArray®:
480bps-contribution to consolidated organic growth for the first
nine months of 2016
Alexandre Mérieux, Chief Executive Officer, said: "bioMérieux
confirmed its strong sales dynamic over the third quarter and
continues to enhance its portfolio of innovative solutions for its
customers. Given this favorable environment and as announced upon
publication of its half-year results, bioMérieux should exceed its
annual 8% organic sales growth target."
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, 2016.
SALES
Consolidated sales came in at €1,512 million for the nine months
ended September 30, 2016, up 10.3% like-for-like from €1,412
million for the same period one year earlier, and up 7.1% as
reported. Reported sales growth reflected a €32 million negative
currency effect, as well as the change in scope mainly resulting
from the deconsolidation of bioTheranostics as of January 1,
2016.
Analysis of sales
In € millions
Sales – Nine months ended September 30, 2015
1,412 Currency effect (31.9) -2.3% Organic growth (at
constant exchange rates and scope of consolidation) 143.7 +10.3%
}+9.5%
Changes in scope of consolidation* (11.6) -0.8%
Sales – Nine
months ended September 30, 2016 1,512 +7.1%
* Deconsolidation of bioTheranostics and consolidation of
Applied Maths as of January 1, 2016. Consolidation of Hyglos as of
June 1, 2016.
Organic growth remained strong in third-quarter 2016, as sales
gained 9.1% on the prior-year period. FilmArray® sales soared 78%,
spurred by accelerated growth of instrument sales. Business in
emerging countries, which accounted for around 25% of the Group's
sales in the third quarter, advanced 10.4% on the year-earlier
period.
Year-on-year trends in third-quarter and YTD nine-month sales
can be summarized by region as
follows:
Sales by
Region
In € millions
Q3 2016 Q3 2015 % changeas reported
% changeat constant exchange rates and scope of
consolidation
9 monthsendedSep. 30,
2016
9 months ended Sep. 30, 2015 % changeas reported
% changeat constant exchange rates and scope of
consolidation Europe(1)
201.6 203.8
-1.1%
+1.0% 618.8 618.8 +0.0%
+1.7% Americas
216.0 186.0 +16.1%
+17.6% 634.1 544.3 +16.5%
+19.6% North America
179.1 151.7 +18.0%
+18.4% 534.5 443.5 +20.9%
+20.5% Latin America
36.9 34.2 +7.8%
+14.2%
99.6 100.8 -1.2%
+14.0% Asia-Pacific
90.9 81.1 +12.0%
+11.6%
253.2 229.9 +10.1%
+12.2%
Total sales from the regions 508.5
470.9 +8.0%
+9.4% 1,506.2
1,393.0 +8.1%
+10.4% bioTheranostics 5.1 14.0
Applied Maths
1.1 2.5 R&D-related revenue
1.2 2.3
3.0
4.5
TOTAL 510.8
478.3 +6.8%
+9.1% 1,511.7
1,411.5 +7.1%
+10.3%
(1) Including the Middle East and Africa.
- The Americas (42% of the YTD
consolidated total) continued to enjoy strong momentum in the
third quarter of 2016, with sales rising 17.6% year-on-year to
€216 million for the period. Sales gained 19.6% year-on-year over
the nine months to September 30, representing €634 million.
- In North America (35% of the YTD
consolidated total), sales came in at €179 million, up more
than 18% year-on-year. Growth in this region continues to be
primarily driven by the rapid development of molecular biology,
mainly through the installation of new FilmArray® systems. Growth
was also buoyed by sales of VIDAS® immunoassay reagents and to a
lesser extent by microbiology reagents.
- In Latin America, third-quarter
sales came in at €37 million, up 14.2% year-on-year in a volatile
currency environment. The good sales dynamic observed in Brazil and
Argentina gathered pace in the third quarter, while the region's
other countries confirmed the trends apparent at the beginning of
the year.
- Sales in the Europe – Middle East –
Africa region (41% of the YTD consolidated total) came to
€202 million for the third quarter, up 1% year-on-year. YTD
sales for the nine months ended September 30 came in at €619
million for the period, a rise of 1.7% compared to the first nine
months of 2015.
- In Western Europe (35% of the
YTD consolidated total), third-quarter sales were 0.7% higher
yearon-year, at €170 million. Germany reported sales growth of
around 5%, offset by the slowdown in France and in certain Southern
European countries. Although organic growth remains satisfactory,
sales in the United Kingdom fell sharply as reported in the third
quarter, hit by a negative currency effect. Market conditions
encountered by the Company in Western Europe are expected to remain
complex in the next quarter.
- Year-on-year sales growth in the
Eastern Europe – Middle East – Africa region was 2.7% for
the third quarter, with good performances in Africa (particularly
Algeria and Tunisia) more than offsetting slower growth in Turkey
and declining sales in the Middle East.
- In the Asia-Pacific region (17%
of the YTD consolidated total), sales ended the third quarter at
€91 million, up 11.6% year-on-year. Sales were 12.2% higher
year-on-year over the nine months ended September 30, at €253
million.
- China, India and South
Korea are the main drivers of growth in the region, posting
gains of close to or over 15%. Sales were driven mainly by the
fast-paced development of industrial applications and by advances
in reagents for VIDAS® immunoassay and clinical microbiology lines.
bioMérieux nevertheless expects growth to slow in the fourth
quarter after this sharp acceleration.
- Sales in Southeast Asia and
particularly Indonesia slowed in the third quarter due to a high
basis of comparison in the same period of last year.
Year-on-year third-quarter and YTD nine-month sales trends can
be summarized by application as
follows:
Sales by
Application
In € millions
Q3 2016 Q3 2015 % changeas reported
% changeat constant exchange rates and scope of
consolidation
9 monthsendedSep. 30,
2016
9 months ended Sep. 30, 2015 % changeas reported
% changeat constant exchange rates and scope of
consolidation
Clinical Applications 405.6
374.3 +8.4%
+9.8% 1,203.7
1,114.9 +8.0%
+10.3% Microbiology
222.6
216.2 +3.0%
+4.2% 649.3 632.5 +2.7%
+5.2%
Immunoassays(1)
108.4 105.7 +2.6%
+4.4% 327.5
315.9 +3.7%
+6.2% Molecular Biology(2)
73.5 50.3
+46.3%
+48.0% 223.0 158.2 +40.9%
+42.1% Other
1.1 2.2 -50.6%
-47.4% 3.9 8.2 -52.6%
-52.3% Industrial Applications 93.6 87.5 +7.0%
+8.7% 275.2 260.3 +5.7%
+8.1% bioTheranostics
5.1 14.0 BioFire Defense
9.3 9.1 +1.7%
+1.9%
27.3 17.9 +52.9%
+53.0% Applied Maths
1.1
2.5 R&D-related revenue
1.2 2.3
3.0 4.5
TOTAL 510.8 478.3
+6.8%
+9.1% 1,511.7 1,411.5
+7.1%
+10.3%
(1) Including VIDAS®: up 6.7% at constant exchange rates and
scope of consolidation in the third quarter and up 8.3% over
nine months.(2) Including FilmArray® sales in an amount of €56
million in the third quarter and €169 million for the nine months
ended September 30.
- Sales of clinical applications,
which account for approximately 80% of the consolidated total,
stood at €406 million for the third quarter, up 9.8% year-on-year.
Clinical application sales represented €1,204 million for the
nine months to September 30, up 10.3% year-on-year.
- Microbiology sales in
third-quarter 2016 were chiefly driven by sales of the BacT/ALERT®
blood culture line and the latest VIRTUO™ line, which increased by
more than 12% year-on-year, and to a lesser extent by culture
media. Sales of the VITEK® automated bacterial identification and
antibiotic susceptibility line continued to grow in all
regions.
- In immunoassays, VIDAS® sales
climbed 6.7% in third-quarter 2016, led by growing sales of
reagents in the Asia-Pacific and Americas regions. This momentum
was driven mainly by growth in high medical value markers and by
the line’s expansion in emerging markets.
- Molecular biology sales in the
third quarter jumped by almost 50%, buoyed by growth in the
FilmArray® line on the back of an expansion in installations
(installed base of almost 3,500 units), and the success of the
Gastro-Intestinal Panel. Ex-U.S. sales continued to enjoy
fast-paced growth, representing around 10% of total FilmArray®
sales for the first nine months of the year. In the third quarter,
bioMérieux obtained clearance from the Chinese Food and Drug
Administration (CFDA) to market and sell its FilmArray® 2.0
system. The panels are still being reviewed by the local
authorities.
- Industrial applications sales
came in at €94 million in third-quarter 2016, up 8.7%
year-on-year. Sales were €275 million for the first nine months of
the year, up 8.1% on the same period in 2015, buoyed by a good
contribution from all regions and certain dynamic countries
including the United States, China, Argentina and Italy. The robust
performance of the VIDAS®, VITEK® and culture media lines drove an
increase in sales to the food industry, which outpaced the increase
in sales of culture media and flow cytometry solutions to the
pharmaceutical industry.
- Over the first nine months of 2016, the
product mix continued to benefit from organic growth in sales of
reagents and services, which rose by 10.9%
year-on-year, and from a 4% gain in instruments.
OTHER INFORMATION
Net debt amounted to €272 million at September 30,
2016, including the €42 million lease financing agreement booked
after the commissioning of the Marcy l’Etoile, France site
extension, versus €219 million at December 31, 2015.
THIRD-QUARTER OPERATING HIGHLIGHTS
- Production and quality
system
On July 8, France's ANSM drug regulatory agency notified
bioMérieux that it had lifted the injunction letter issued in
February 2015 following completion by bioMérieux of compliance work
on certain production units at the facility in Craponne,
France.
- Next generation
BacT/ALERT® VIRTUO™ blood culture system gets
CE-marked and is submitted to the FDA for 510(k) clearance
In July, bioMérieux announced the CE-marking of an updated
release of its innovative BacT/ALERT® VIRTUO™ automated blood
culture system, featuring new capabilities.
The next generation system features blood level detection that
directly measures the blood volume added to each blood culture
bottle at loading time, to track and ensure collection of the
recommended blood volume. The new system can also combine up to
three additional incubator subunits connected to a command module
in a single BacT/ALERT® VIRTUO™ bank, thereby creating an
integrated configuration. This scalable configuration can incubate
between 428 and 1,712 cells, enabling the management of high
volumes of up to 100,000 blood culture bottles per year with a
single entry point.
This new BacT/ALERT® VIRTUO™ system has been submitted to the
U.S. Food and Drug Administration (FDA) for 510(k) clearance.
- Pathogen identification capability
on VITEK® MS broadened to mycobacteria, Nocardia, and
molds
bioMérieux has announced the launch of the first CE-marked
database and reagent kits for the identification of mycobacteria,
Nocardia, and molds in a mass spectrometry system. These
difficult-to-identify organisms require days or weeks of specific
culture conditions for appropriate growth and subsequent advanced
methods for reliable identification to species level.
The VITEK® MS extended database now enables the identification
within minutes of 1,046 species representing 15,172 distinct
strains of bacteria, yeasts and molds. It is part of a fully
integrated solution combining identification with VITEK® MS and
antibiotic susceptibility testing with VITEK® 2, resulting in
superior laboratory workflow management.
SUBSEQUENT EVENTS
- Launch of EviSight™ Compact, a new
automated diagnostic solution for microbial detection in
pharmaceutical production
On October 6, bioMérieux announced the launch of EviSight™
Compact, an intelligent incubation system providing real-time
culture media reading. For use in pharmaceutical industry R&D
and production settings, EviSight™ Compact combines incubation,
intelligent automated detection and enumeration of colonies of
bacteria, yeasts and molds in a single system. This innovative
launch results from bioMérieux's acquisition of Advencis
(Strasbourg, France) in October 2014.
- BIOASTER, bioMérieux, ESPCI, GSK,
Hospices Civils de Lyon and Sanofi join forces against
sepsis
On October 10, bioMérieux announced that it had signed up to the
REALISM (REAnimation Low Immune Status Markers) research program
alongside BIOASTER, the French institute for microbiology
technology innovation, ESPCI (Paris College of Physics and
Industrial Chemistry), GSK, the Hospices Civils de Lyon (HCL) and
Sanofi. The program is to be conducted within BIOASTER and the
joint research laboratory HCL-bioMérieux, and aims to identify and
validate new biomarkers for improving care of patients presenting a
high risk of sepsis. The highly original combination of public and
private research combines medical expertise, academic research as
well as diagnostic and pharmaceutical innovation in order to fight
this public health threat.
- FilmArray® Respiratory
Panel EZ receives FDA clearance for professional use outside
laboratories
On October 11, bioMérieux announced that BioFire Diagnostics,
LLC, its molecular biology affiliate, received U.S. FDA 510(k)
clearance and Clinical Laboratory Improvement Amendments (CLIA)
waiver for the FilmArray® Respiratory Panel EZ (FilmArray® RP EZ).
The CLIA waiver permits use of the test outside traditional
clinical laboratories in sites such as physician's offices and
urgent care centers.
FilmArray® RP EZ detects 11 viral and 3 bacterial pathogens
associated with upper respiratory infections from a single patient
sample and is a simplified version of the CE-marked FDA-cleared
FilmArray® Respiratory Panel. The FilmArray® RP EZ will be
available on the U.S. market only, BioFire anticipates commercial
launch in November 2016.
- Lyme disease diagnostic
tests
Like other IVD companies, bioMérieux has been summoned to appear
before the Paris Regional Court (Tribunal de Grande Instance de
Paris) by 45 patients claiming compensation for anxiety prejudice
allegedly “generated by a lack of reliability of serodiagnostic
tests” for Lyme disease.
bioMérieux will object to the requests made under the subpoena,
which, in light of the available information, appears to be
unfounded. The Company is unable to reliably estimate the financial
consequences of this civil case at this stage in the
proceedings.
INVESTOR CALENDAR
Fourth-quarter 2016 sales: January 19, 2017, 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 2015 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 more
than 50 years, bioMérieux is present in more than 150 countries
through 42 subsidiaries and a large network of distributors. In
2015, revenues reached €1,965 million with 90% 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 mainly used for diagnosing infectious diseases. They are also
used for detecting microorganisms in agri-food, pharmaceutical and
cosmetic products.
bioMérieux is listed on the Euronext Paris stock market(Symbol:
BIM/Reuters: BIOX.PA/Bloomberg: BIM.FP – 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
Full-year 2016 2015 2016
2015 2016 2015 2016 2015 Europe(1)
206.9 204.0 210.3 210.9 201.6
203.8 618.8 618.8 Americas 212.8 176.5 205.3 181.9
216.0 186.0 634.1 544.3 North America 182.9 144.7 172.5 147.1 179.1
151.7 534.5 443.5 Latin America 29.9 31.8 32.9 34.8 36.9 34.2 99.6
100.8 Asia-Pacific 67.4 61.9 95.0 86.9
90.9 81.1 253.2 229.9
Total sales
from the regions 487.1 442.4
510.6 479.6 508.5
470.9 1,506.2 1,393.0
bioTheranostics 4.1 4.8
5.1 14.0 Applied Maths
0.6 0.7 1.1
2.5 R&D-related revenue 0.8
1.4 1.0 0.8 1.2 2.3 3.0
4.5
TOTAL 488.5 447.9
512.3 485.3 510.8
478.3 1,511.7 1,411.5
(1) Including the Middle East and Africa.
% Change in Sales by Region
First quarter Second quarter Third quarter
Full-year As reported Like-for-like
As reported Like-for-like As reported
Like-for-like As reported Like-for-like Europe(1)
+1.4% +2.4% -0.3% +1.7% -1.1%
+1.0% +0.0% +1.7% Americas +20.6% +22.5% +12.9%
+18.8% +16.1% +17.6% +16.5% +19.6% North America +26.4% +24.0%
+17.3% +20.3% +18.0% +18.4% +20.9% +20.5% Latin America -6.0%
+15.9% -5.6% +12.5% +7.8% +14.2% -1.2% +14.0% Asia-Pacific
+8.9% +10.7% +9.3% +13.9% +12.0%
+11.6% +10.1% +12.2%
Total sales from the
regions +10.1% +11.6%
+6.5% +10.4% +8.0%
+9.4% +8.1% +10.4%
bioTheranostics
Applied Maths
R&D-related revenue
TOTAL +9.1% +11.5%
+5.6% +10.3% +6.8%
+9.1% +7.1% +10.3%
(1) Including the Middle East and Africa.
Sales by Application in € millions
First quarter Second quarter Third quarter
Full-year 2016 2015 2016
2015 2016 2015 2016 2015 Clinical
Applications 392.9 356.8 405.3 383.8
405.6 374.3 1,203.7 1,114.9 Microbiology 206.9
198.1 219.9 218.2 222.6 216.2 649.3 632.5 Immunoassays 104.1 97.6
115.1 112.6 108.4 105.7 327.5 315.9 Molecular Biology(1) 80.2 57.6
69.3 50.3 73.5 50.3 223.0 158.2 Other 1.7 3.5 1.1 2.6 1.1 2.2 3.9
8.2 Industrial Applications 86.0 82.5 95.5
90.3 93.6 87.5 275.2 260.3
bioTheranostics 4.1 4.8
5.1 14.0 BioFire Defense
8.2 3.1 9.8 5.6 9.3 9.1
27.3 17.9 Applied Maths 0.6
0.7 1.1 2.5
R&D-related revenue 0.8 1.4 1.0
0.8 1.2 2.3 3.0 4.5
TOTAL
488.5 447.9 512.3
485.3 510.8 478.3
1,511.7 1,411.5
(1) Including FilmArray® sales.
% Change in Sales by Application
First quarter Second quarter Third quarter
Full-year As reported Like-for-like(2)
As reported Like-for-like(2) As reported
Like-for-like(2) As reported Like-for-like
Clinical Applications +10.1% +11.6% +5.6%
+9.6% +8.4% +9.8% +8.0% +10.3%
Microbiology +4.4% +6.7% +0.8% +4.9% +3.0% +4.2% +2.7% +5.2%
Immunoassays +6.6% +8.6% +2.1% +6.1% +2.6% +4.4% +3.7% +6.2%
Molecular Biology(1) +39.2% +37.1% +37.6% +42.0% +46.3% +48.0%
+40.9% +42.1% Other -50.7% -51.6% -57.0% -57.7% -50.6% -47.4%
-52.6% -52.3% Industrial Applications +4.1% +6.1%
+5.8% +9.4% +7.0% +8.7% +5.7%
+8.1% bioTheranostics
BioFire Defense x 2.7 x 2.6
+73.9% +76.6% +1.7% +1.9% +52.9%
+53.0% Applied Maths
R&D-related revenue
TOTAL +9.1% +11.5%
+5.6% +10.3% +6.8%
+9.1% +7.1% +10.3%
(1) Including FilmArray® sales.(2) At constant exchange rates
and scope of consolidation.
NB: Unless otherwise stated, growth
is expressed year-on-year at constant exchange rates and scope of
consolidation (like-for-like).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161019006547/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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