bioMérieux - First-Half 2015 Business Review

Regulatory News:

bioMérieux (Paris:BIM):

• Strong growth in business
  • €933 million in sales
  • Up 19.5% as reported
  • Up 8.1% like-for-like
• Fast-rising sales in the Americas, up 18.3%, and a return to more sustained expansion in the Asia-Pacific, up 6.6%
• Robust demand in the priority areas for growth
  • FilmArray^® sales doubled year-on-year, installed base expanded to nearly 1,900 instruments
  • Solid 5.0% gain in clinical microbiology
  • Sustained 7.4% improvement in VIDAS^® sales
  • Satisfactory 4.4% growth in industrial applications

Alexandre Mérieux, Chief Executive Officer, said: "In the first half of 2015, bioMérieux delivered a fast 8.1% increase in sales on a like-for-like basis. The first six months attest to continued strong sales momentum in North America and robust performances in our main strategic businesses. In particular, FilmArray^® continued to demonstrate remarkable success by doubling its sales over the period. It once again fulfilled its role as a driver of faster growth for the Group and strengthened its leadership in the syndromic diagnosis of infectious diseases. The period saw signs of a gradual return to more energetic growth in China. As a result, we are confirming the 2015 organic sales growth objective set earlier this year."

bioMérieux, a world leader in the field of in vitro diagnostics, today released its business review for the six months ended June 30, 2015.

SALES

Consolidated sales amounted to €933 million in the first half of 2015, up from €781 million in the year-earlier period. This represented growth of 8.1% like-for-like and of 9.1% after changes in the scope of consolidation related to the BioFire and CEERAM acquisitions. Reported growth stood at 19.5%, lifted by the €81 million (10.4%) positive effect of the increase in the US dollar and other currencies against the euro over the period.

⁽¹⁾ BioFire: sales from January 1 to January 15, 2015 excluded from the organic growth calculation. (acquisition date: Jan 16 2014)
CEERAM: first-time consolidation of sales from this technological start-up acquired in late December 2014.

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

bioMérieux's first-half sales performance was very satisfactory, as robust momentum in the Americas and a rebound in the Asia-Pacific region offset the slight decline observed in the second quarter in the Europe – Middle East – Africa region.

FilmArray^® confirmed its role as a driver of faster growth for the Group, adding approximately 300 basis points to the gains generated by the other bioMérieux lines. This solid dynamic attests to the successful take-up of the syndromic approach to infectious disease testing, notably in North America.

First-half 2015 sales by region may be summarized as follows.

⁽¹⁾ Including the Middle East and Africa.

• Sales in the Europe – Middle East – Africa region (45% of the consolidated total) come to €415 million for the period, up 1.8% year-on-year.
  • In Western Europe (39% of the consolidated total), sales rose by a slight 1.2% year-on-year overall, with conditions varying by geography. Sales in Northern Europe were lifted by rising demand in the United Kingdom, Germany, Switzerland and the Nordic countries. French sales contracted by 2.8% year-on-year, pushed down by unfavorable market conditions in terms of both test volumes and pricing. In Southern Europe, sales inched up 0.4% year-on-year, despite the economic situation in Greece and a slight slowdown in business in Spain and Italy.
  • Sales in Eastern Europe, the Middle East and Africa rose by more than 5% year-on-year, supported by a solid performance in Turkey and South Africa. Geopolitical tensions continued to hamper growth, particularly in Russia and the Middle East.
• The pace of growth remained very strong in the Americas, with sales climbing 18.9% year-on-year to €350 million.
  • In North America (32% of the consolidated total), sales rose by more than 22% year-on-year, led by FilmArray^®'s dramatic 106% growth and the sustained 9% increase in the other bioMérieux lines, driven in particular by the installation of VITEK^® MS mass spectrometry systems in certain reference labs and by the continued strong sales of the VIDAS^® B.R.A.H.M.S PCT™ test for the diagnosis of sepsis in emergency situations.
    In industrial applications, firm demand from the pharmaceuticals and cosmetics industries lifted year-on-year growth to 7.5%.
  • Sales in Latin America (7% of the consolidated total) ended the period up 9.3%, as robust growth in Argentina, Chile and Colombia, particularly in clinical microbiology, offset a 1% year-on-year decline in Brazil and slightly slower growth in Mexico.
• Sales rebounded in the Asia-Pacific region (16% of the consolidated total), rising 6.6% year-on-year to €149 million.
  • Operations in China reported a 10% gain, up sharply from the prior-year period thanks to the solid performance of VIDAS^® and VITEK^® reagents in clinical applications and the increase in sales to private laboratories in industrial applications.
  • In the rest of the region, growth was led by year-on-year improvements in India (up 9.1%) and South Korea (up 6.2%).

First-half 2015 sales by application may be summarized as follows.

⁽¹⁾ Of which growth in VIDAS^® sales of 7.4% in the first half of 2015 and 6.4% in the second quarter, at constant exchange rates and scope of consolidation.
⁽²⁾ Including BioFire Diagnostics sales of €67 million in the first half of 2015 and €30 million in the second quarter.

• Sales of clinical applications advanced by a solid 8.6%.
  • Molecular biology sales surged by nearly 50% year-on-year thanks primarily to FilmArray^®'s excellent first-half performance, which was driven by expansion of the installed base and of the demand for the related panels. The easyMAG^® and ARGENE^® lines reported sustained sales, up 8% and 16% respectively on the prior-year period.
  • In immunoassays, VIDAS^® sales ended the first-half up 7.4% year-on-year. Reagent sales continued to expand, rising almost 10% on the nearly 20% increase delivered by the high medical value reagents (especially VIDAS^® B.R.A.H.M.S PCT™). On the other hand, instrument sales were penalized by the situation in the Middle East, Africa and the Asia-Pacific.
  • Microbiology sales rose by 5.0% year-on-year to €416 million. The ID/AST lines (VITEK^® 2 and VITEK^® MS) gained more than 8%, led by equipment sales in the Americas and Asia-Pacific regions and by reagent sales worldwide. In addition, the blood culture line (BacT/ALERT^® and VIRTUO™) saw an increase of 3.4%, as the improved production conditions at the Durham, NC site made it possible to effectively meet customer demand, particularly in the Europe – Middle East – Africa, Latin America and Asia-Pacific regions.
• Industrial applications, which account for 19% of consolidated sales, rose by 4.4% year-on-year. Sales increased in the United States, China and Europe, supported by demand for bacteria identification instruments and culture media. Sales in France eased by a slight 1.3% against a backdrop of measures to rationalize the third-party product portfolio.
• Sales of reagents and services, which represented 90.4% of the consolidated total, rose by nearly 8% on an organic basis, with equipment sales gaining 8.5%.

OTHER INFORMATION

• Installed base
  
  The installed base at June 30, 2015 stood at approximately 81,200 instruments, including 1,867 FilmArray^® instruments. This represented an increase of 1,700 new instruments over the period, of which 266 FilmArray^® units.
• Consolidated income statement
  
  The first-half 2015 financial results will be released on August 31, 2015. In light of this, and given the scale of the Group's U.S. operations, it should be noted that bioMérieux bears substantial dollar-denominated operating costs, which partly offset the positive currency impact on sales at the contributive operating income level. Furthermore, in accordance with its hedging policy, the Group has gradually set up exchange-rate transactions since summer 2014 to hedge its 2015 net exposure to most of the currencies in which it operates. Lastly, bioMérieux's exposure to Greek receivables stands at €4 million at June 30, 2015.
• Net debt
  
  Net debt amounted to €274 million at June 30, 2015 after payment of the dividend (€39 million) versus €249 million at December 31, 2014.
  
  The Company has issued €300 million in seven-year bonds, which were placed with institutional investors in October 2013. It also has a €350-million syndicated line of credit expiring on May 20, 2019. Lastly, on March 31, 2015, it signed a 12-year, €45-million lease financing agreement to fund the extension of the Marcy l'Etoile site.
  
  The Group's capital projects are proceeding as planned. However, given the use of lease financing to fund the Marcy l'Etoile extension, the corresponding asset will be recognized in full when the completed project is accepted in 2016. As a result, capital expenditure should total around €160 million, rather than the €200 million estimated last March.

SECOND-QUARTER OPERATING HIGHLIGHTS

• De novo application submitted for the FilmArray^®Meningitis/Encephalitis Panel
  
  In April 2015, BioFire submitted a de novo classification request to the US Food and Drug Administration (FDA) for the FilmArray^® Meningitis/Encephalitis (ME) Panel. The pioneering FilmArray^® ME Panel addresses a critical, unmet need for quickly identifying central nervous system infections by utilizing a comprehensive panel to test cerebrospinal fluid (CSF) for the most common bacteria, viruses and fungi responsible for community-acquired meningitis or encephalitis. A one-hour or so turnaround time has the potential to reduce mortality and morbidity from these devastating diseases and to positively impact patient management. FilmArray^® ME will only be available for sale once the FDA has completed its process. The Panel will be the fourth clinical diagnostic test to run on the FilmArray^® system, making its syndromic menu the largest commercially available for a multiplexing platform.
• Production and quality system
  
  In June 2015, the FDA re-inspected the site in St. Louis, Missouri 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. Following the inspection, the FDA issued two new observations, which bioMérieux is already addressing with a corrective action plan.
  
  The sites 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 and prepare for the coming re-inspections.
• The fight against antibiotic resistance
  
  On June 2, bioMérieux participated in the White House Forum on Antibiotic Stewardship, making an active contribution to discussions concerning the Obama administration's National Action Plan for Combating Antibiotic-Resistant Bacteria.
  
  Also in June, bioMérieux organized the fifth World HAI/Resistance Forum, during which more than 70 world renowned experts met to share their global experience and expertise in antimicrobial resistance in humans, animals, the environment and food. The discussions confirmed that coordinated action between human and veterinary medicine is essential to effectively combat this global public health threat. The experts also underlined the need for education of healthcare professionals as well as other user targets. Among other actions, they selected as a priority the development of an international project, which bioMérieux committed to support.

POST-BALANCE SHEET EVENT

• VIDAS^® 3 cleared by the FDA
  
  On July 9, bioMérieux received 510(k) clearance from the FDA to market VIDAS^® 3, the new generation of VIDAS^® that further enhances the range of automated VIDAS^® and miniVIDAS^® immunoassay instruments in the United States. VIDAS^® 3 reinforces the ease of use that has made the VIDAS^® range so popular. Thanks to its design, tests can be performed on demand, individually or in series, 24 hours a day and seven days a week. As a result, it is perfectly suited to centralized as well as satellite laboratories, bringing both versatility and reliability to healthcare professionals who are able to optimize their workflows and guarantee the quality of biological testing.

2015 OBJECTIVE

Based on the current sales outlook, the Company is confident that it will meet its objective of reporting between 4.5% and 6.5% organic growth in sales in 2015, at constant exchange rates and scope of consolidation.

INVESTOR CALENDAR

First-half earnings: August 31, 2015, before start of trading
Third-quarter sales: October 22, 2015, 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

⁽¹⁾ Including the Middle East and Africa.

⁽¹⁾ Including the Middle East and Africa.

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