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UPDATE: BioMerieux Logs 4 Percent Organic Growth in 1H 2014; BioFire Helps Drive Molecular Bio Gains

This story has been updated from a version originally published on July 17 to incorporate additional figures from BioMérieux's first-half financial results, which were released today.

NEW YORK (GenomeWeb) — BioMérieux has reported 4 percent organic revenue growth for the first half of 2014 driven in part by a 4 percent increase in clinical revenues and a nearly 10 percent spike in clinical molecular biology sales.

The company also said that clinical molecular biology sales increased by 70 percent in 1H when including the contribution from newly acquired BioFire Diagnostics.

For the six months ended June 30, the Marcy L'Etoile, France-based in vitro diagnostics firm, which trades on the NYSE Euronext Paris market, reported net sales of €781 million ($1.06 billion) compared to €754 million in 1H 2013, an increase of nearly 4 percent.

However, the company said that exchange rate fluctuations resulted in a negative currency effect of €33 million, and that excluding this effect organic growth was just above 4 percent.

In addition, consolidated sales included €28 million in sales generated by BioFire since its acquisition in January — €28 million from BioFire's core business and €5 million from its BioFire Defense subsidiary — driving an 8 percent increase in sales at constant exchange rates. BioFire's sales represented a year-over-year gain of about 42 percent compared to its sales in the same period last year, prior to the acquisition.

BioMérieux breaks its earnings out into clinical applications, which include microbiology, immunoassays, molecular biology, and other; and industrial applications. In the first half of 2014, the company reported €620 million in clinical applications sales, a nearly 4 percent increase over €597 million in the year-ago period, or just above 4 percent at CER. Industrial applications sales, meantime, totaled €157 million, essentially flat compared to the year-ago period but up about 1 percent CER.

The company's clinical molecular biology offerings include BioFire revenues, as well as sales of instrumentation such as the easyMAG sample purification platform, easySTREAM liquid handling system for PCR assay set-up, Life Technologies' (Thermo Fisher Scientific) real-time PCR instruments, and NucliSentral software; and Argene real-time PCR assays specific for immunocompromised patients and respiratory and meningo-encephalitis infections.

In the first half of the year, this segment reported €62 million in revenues compared to €37 million in the same period in 2013 — an increase of 70 percent including the contribution of BioFire. However, segment revenues grew nearly 10 percent year over year organically, primarily due to "fast growth" in the Argene product line, BioMérieux said.

BioMérieux also said that it has begun discussions with BioFire distributors, and that beginning this month the platform will be directly marketed by the company's local sales subsidiaries in eight European countries. Fees due on the cancellation of existing distributorship agreements are expected to total a little more than €1 million as of the end of June, and will be recognized as a non-recurring operating expense.

In the first half of the year, BioMérieux placed 150 new FilmArray units, and as of June 30 the company said it had an installed base of more than 860 systems. The platform is now commercially available in the US, in 25 European countries that recognize CE marking, Hong Kong, Australia, Thailand, and other countries that do not require regulatory licenses. The firm is currently seeking regulatory approval in other countries such as China, India, and Brazil.

During the second quarter, the FilmArray GI panel received 510(k) clearance from the US Food and Drug Administration and was CE marked. This 22-target panel enables a syndromic approach to diagnosing infectious diarrhea since it includes bacteria, viruses, and parasites in one test.

In other company segments, BioMérieux's first-half clinical microbiology sales shrunk about 3 percent to €365 million from €377 million, but rose 1 percent at CER, driven in particular by strong performance in the automated ID/AST product line, culture media, and full microbiology lab automation solutions.

This segment also includes the company's Vitek MALDI-TOF mass spectrometry system for the identification of bacteria and yeast, which received 510(k) de novo clearance by the FDA last August. The company did not break out sales contributions for the Vitek platform, but noted that it installed a large number of systems in the US in 1H, helping to drive a 7 percent increase in overall revenues in the Americas, which represents about a third of consolidated sales at the company.

Meantime, its clinical immunoassays sales increased almost 6 percent to €185 million from €175 million, or 10 percent at CER, while other clinical product sales grew about 3 percent to €8 million, or almost 9 percent CER.

BioMérieux spent €99.6 million on R&D in the first half of the year compared to €89.5 million in 1H 2013. Meantime, SG&A expenses totaled €215.2 million in the first half compared to €198.5 million in the year-ago period.

Net income attributable to the parent company was €52.3 million, or €1.32 per share, compared to €79.7 million, or €2.02 per share, in 1H 2013.

BioMérieux ended the first half with €95.1 million in cash and cash equivalents.

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