bioMérieux – Fourth-Quarter 2015 Business Review

Regulatory News:

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today released its business review for the twelve months ended December 31, 2015.

SALES

Consolidated sales amounted to €1,965 million in 2015, up 15.7% from the €1,698 million reported the year before, in part due to the €136-million positive currency effect (of which €108 million attributable to the US dollar). At 7.1%, like-for-like growth exceeded the objective for the year, thanks in particular to the around 300 basis-point boost from surging growth in FilmArray^® sales.

Fourth-quarter sales stood at €553 million, representing organic growth of 4.0% year-on-year. This was slower than in the previous quarters due to unfavorable prior-year comparatives and to a flu season that had not started by the year-end. Nevertheless, sales for the period were lifted by the robust momentum in North America and, to a lesser extent, the solid performance from operations in the ASEAN nations (especially Indonesia, Thailand, Singapore and the Philippines) and in certain European countries (Spain, Portugal and Germany).

Sales for full-year and fourth-quarter 2015 may be summarized by region as follows:

? Sales in the Europe – Middle East – Africa region (43% of the total from the regions) came to €843 million for the year, up 2.1% from 2014. Fourth-quarter sales edged up slightly year-on-year to €224 million.

• In Western Europe (37% of the total from the regions), sales rose by nearly 1% over the year and were stable in the fourth quarter.
  The good performance in Germany (up 5%), the United Kingdom (up 6%) and the Nordic countries (up 7%), as well as the rebound in Southern Europe (except in Greece), helped to offset the slowdown in France, where demand was dampened by the ongoing consolidation of clinical laboratories. This was particularly the case for immunoassays, where sales of low-throughput VIDAS^® instruments declined. Launched in 2015, the new Lab Efficiency microbiology laboratory automation suite should enable the Company to respond effectively to this changing market environment as of 2016.

• Sales in the Eastern Europe – Middle East – Africa region climbed nearly 9% year-on-year, led by a good performance in Turkey, Algeria and Russia. However, the region remains highly volatile due to prevailing geopolitical instability.

? Operations in the Americas reported €749 million in sales for the year, up 16.2% from 2014, and €205 million for the fourth quarter, up 11.6%.

• North American sales (32% of the total from the regions) rose by 18.9% over the year and by 14.6% in the final quarter. Growth in the clinical segment was led by the take-up of the FilmArray^® system and its extensive menu, which now comprises four panels; by the brisk performance of the VIDAS^® line, particularly the ever-popular VIDAS^® B•R•A•H•M•S PCT™; and by the close alignment of the VITEK^® automated bacterial identification and antibiotic susceptibility testing (AST) system with the increasing need to automate microbiology labs. In addition, industrial applications delivered robust growth driven by growing demand for sterility tests in the pharmaceuticals industry.

• In Latin America (7% of total sales from the regions), year-on-year growth stood at 7.4%, with every country organization reporting strong gains, including 10% in Mexico, 14% in Colombia and 25% in Argentina. The only exception was Brazil, where sales eased back slightly over the year.
  Sales of microbiology reagents and the FilmArray^® line's encouraging start-up fueled faster growth in clinical applications.

? Sales in the Asia-Pacific region (18% of the total from the regions) amounted to €347 million for the year, up 3.3%, and to €118 million for the fourth quarter, up by more than 1.2%.

• Sales rose across the region except in South Korea, where instrument sales fell off sharply in a cooling, consolidating market.
• Sales in China ended the year up 2.1% as solid growth in reagent sales offset weaker demand for equipment. The year was shaped by the good performance from VIDAS^® reagents and molecular biology products, with in particular an increase in FilmArray^® sales in Hong Kong, and by the return to growth in industrial applications thanks to the development of new private-sector customer segments.
• In the rest of the region, operations in India continue to enjoy fast growth, led by the microbiology and immunoassay lines and by industrial applications. Sales in the ASEAN region rose by nearly 9% year-on-year.

Sales for full-year and fourth-quarter 2015 may be summarized by application as follows:

? Sales of clinical applications ended the year at €1,552 million, representing organic growth of 7.1%. Fourth-quarter sales were up 3.8% year-on-year.

• Microbiology sales totaled €879 million, lifted in every region by the growth in the VITEK^® automated ID/AST lines, in particular the AST cards and the VITEK^® MS mass spectrometry instruments, which turned in double-digit growth.
  By year-end, the blood culture line had returned to growth, led by instrument sales as relations with the customer base gradually got back to normal. In addition, a more assertive marketing strategy was deployed following the launch of the new, more automated VIRTUO™ system and of new reagents, like the BacT/ALERT^® FAN^® Plus bottles that neutralize antibiotics more effectively.

• In Immunoassays, sales of the VIDAS^® line climbed 8.2% over the year, reflecting remarkable momentum in reagents, which delivered double-digit growth in every region except the slightly weaker Western Europe. In particular, growth was lifted by high medical value reagents, especially VIDAS^® B•R•A•H•M•S PCT™, which now accounts for around 7% of consolidated sales.
• Molecular biology sales surged by nearly 40% over the year. Despite the absence of a peak in the 2015 flu season, this robust growth was primarily supported by FilmArray^®'s excellent performance, which was driven by the expansion of the installed base and the customer portfolio, as well as by demand for the related panels. The Respiratory Panel was once again the FilmArray^® line's best seller, with the more recently launched panels, such as the Gastrointestinal Panel and the Meningitis/Encephalitis Panel, enjoying strong growth.
  The ARGENE^® line reported solid growth of more than 10% compared with 2014.

? Sales of industrial applications (18% of the consolidated total) ended the year at €363 million, a 4.4% gain on 2014 shaped by the healthy 6.0% year-on-year improvement in the fourth quarter. The vitality of sales in North America, the METERA region and certain European countries helped generate more sustained growth, led by the VITEK^® and VIDAS^® bacteria identification lines and by culture media.

? Organic growth in sales of reagents and services, which accounted for 88% of the consolidated total, came to 7.1% for the full year.

OTHER INFORMATION

? Installed base

At December 31, 2015, the installed base amounted to approximately 84,500 instruments, including in particular 2,500 FilmArray^® units. It rose by 5,000 new systems during the year, of which around 1,100 FilmArray^® instruments.

? Net debt

Net debt amounted to €218 million at December 31, 2015, versus €249 million at December 31, 2014.

? Human resources

As of December 31, 2015, the Company had a total of 9,438 full-time-equivalent employees and temporary staff.

FOURTH-QUARTER OPERATING HIGHLIGHTS

? Production and quality system

In December 2015, the US Food and Drug Administration (FDA) re-inspected the Durham, NC site and reviewed all of the corrective actions that bioMérieux had pledged to implement. The FDA referenced no observations or concerns regarding corrective actions related to bioMérieux’s previous 483 and Warning Letter commitments and determined that there were no repeat observations as regards the Letter. Following the inspection, the FDA issued new observations, and bioMérieux is providing a timely response.

? FDA clearance and CE-mark received for the FilmArray^® Meningitis/Encephalitis Panel

On October 8, 2015, 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. In just around an hour, it uses a comprehensive panel to test cerebrospinal fluid (CSF) for the 14 most common pathogens (six bacteria, seven viruses and one fungus) responsible for community acquired meningitis or encephalitis.

The FilmArray^® ME Panel was commercially launched in the United States in November 2015 and CE-marked on January 8, 2016. It can be run on the FilmArray^® and FilmArray^® 2.0 multiplex PCR systems.

? Acquisition of Applied Maths

On January 5, 2016, bioMérieux announced the acquisition of Applied Maths, a developer of state-of-the-art software solutions for the biosciences, in particular for databasing, analysis and interpretation of complex biological data. Building on more than 20 years of expertise, Applied Maths develops and commercializes BioNumerics universal software for microbiology applications, including in bacteriology, virology and mycology.

Initially, the acquisition of Applied Maths will enrich and expand the bioMérieux EpiSeq™ service in next-generation sequencing (NGS) for the epidemiological monitoring and control of healthcare-associated infections. Taking a longer term perspective, synergies are foreseen in the field of clinical microbiology, particularly to optimize bioMérieux’s data management tools and unique collection of clinically-relevant bacterial strains and to consolidate data from its installed base of 84,500 instruments. Synergies will also be developed in industrial microbiology to facilitate the traceability and investigations of epidemics all along the food chain.

? Commercial offer

In November 2015, bioMérieux announced the launch of GENE-UP^®, its new PCR-based molecular diagnostic system for the detection of microorganisms (bacteria and viruses). The platform enables the microbiological control of food, raw materials and the production environment for customers in the agri-food sector. The innovative solution considerably simplifies lab workflow, improving productivity while limiting the risk of inter-sample contamination.

In December 2015, bioMérieux and Illumina jointly announced the introduction of bioMérieux EpiSeq™, an innovative next-generation sequencing (NGS) service dedicated to the epidemiological monitoring and control of healthcare-associated infections. It is the first result of the collaboration agreement signed by bioMérieux and Illumina in November 2014 bringing together the companies’ respective leadership positions in microbiology and NGS to jointly develop applications for microbiology sequencing.

In addition, bioMérieux launched VIDAS^® High sensitive Troponin I, a new high sensitivity generation of the VIDAS^® troponin assay. In just two hours, the new test, which has extended the range of high medical value VIDAS^® assays, delivers a diagnosis – safe rule-out and accurate rule-in – of acute myocardial infarction in 70% of emergency room chest pain patients. "Compared with standard cardiac troponins, high sensitivity cardiac troponin I assays allow the use of rapid rule-out and rule-in protocols for acute myocardial infarction which may result in substantial reductions in the time to decision and/or diagnosis in patients with chest pain, and therefore total stay in the emergency department," explains Dr. Bertil Lindahl, Professor of cardiology at the Uppsala Clinical Research Center in Sweden.

In addition, bioNexia H. pylori Ag, a rapid test for the non-invasive detection of Helicobacter pylori antigen in stool samples, is now CE-marked. One of the most widespread chronic infections on Earth, the Helicobacter pylori antigen colonizes the stomach, leading to dyspepsia, as well as to gastric or duodenal ulcers among 1-10% of the infected population. In addition, it is recognized as the first microorganism involved in the development of stomach cancer, which will impact 0.3-3% of infected people.

Lastly, bioMérieux introduced the new MERS-HCoV r-gene^® research-use only (RUO) kit that enables laboratories to prepare a test to detect the MERS coronavirus¹. The MERS-HCoV r-gene^® kit is a molecular solution that can be used to detect and screen for the pathogen with a single PCR assay per sample. Coronaviruses (CoV) are primarily the cause of respiratory and enteric diseases in people and certain animals. MERS represents a major public health risk, with a reported mortality rate of around 36%.

SUBSEQUENT EVENTS

? bioTheranostics capital increase

bioTheranostics develops molecular-based tests that are used to characterize metastatic cancers and estimate the risk of breast cancer recurrence. It runs these tests in its CLIA (Clinical Laboratory Improvement Amendments) service lab, whose activities are not directly related to bioMérieux’s core business, the in vitro diagnosis of infectious diseases. As previously announced, bioMérieux has been seeking outside partners in order to accelerate the growth of bioTheranostics

In this regard, bioMérieux today announces an equity investment by MVM Life Science Partners, Canepa Advanced Healthcare Fund and HealthQuest Capital in bioTheranostics. On completion of the transaction, bioMérieux will own less than 20% of bioTheranostics which will remain fully consolidated until December 31, 2015 after which it will be removed from bioMérieux’s consolidation scope. The Company estimates that the operation will have a negative post-tax impact of approximately €28 million on the Group’s 2015 consolidated financial statements, which will be recorded in non-recurring items, and no material impact on the Group’s cash position.

? FilmArray^® Torch submitted for FDA clearance for use with the FilmArray^® Respiratory Panel

bioMérieux has submitted the new FilmArray^® Torch system to the US Food and Drug Administration (FDA) for special 510(k) clearance for use with the FilmArray^® Respiratory Panel.

The FilmArray^® Torch is the latest advancement in syndromic infectious disease molecular testing from BioFire Diagnostics. Scalable by design, the two-module base configured FilmArray^® Torch is capable of testing up to 42 patient samples per day, while the 12-module, fully configured FilmArray^® Torch is capable of testing up to 262 patient samples per day.

In the coming weeks, bioMérieux also intends to seek 510(k) clearance of the FilmArray^® Torch for use with all existing FDA-cleared FilmArray^® panels, including the FilmArray^® Blood Culture Identification Panel, the FilmArray^® Gastrointestinal Panel and the FilmArray^® Meningitis/Encephalitis Panel.

2016 ORGANIC SALES GROWTH TARGET

In a business environment that remains volatile due to widely varying economic and geopolitical situations in the different regions, FilmArray^® sales are expected to materially contribute to the Group’s growth in 2016, with the other lines delivering gains in step with their markets.

As a result, bioMérieux has set an organic growth target of between 6.0% and 8.0% for the year, on a like-for-like basis, and assuming a normal flu season.

In line with its roadmap, the Company will continue to make the necessary research and commercial investments to pursue its strategy of innovation and internationalization, its two major growth drivers for the years ahead. At the same time, it will further adapt and improve its production facilities and strengthen its quality management organization.

¹ Middle East Respiratory Syndrome.

INVESTOR CALENDAR

2015 financial results: March 2, 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 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 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 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

% Change in Sales by Region

Sales by Application in € millions

% Change in Sales by Application

NB: Unless otherwise stated, growth is expressed year-on-year at constant exchange rates and scope of consolidation (like-for-like).

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