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UPDATE: BioMérieux Q1 Revenues up 7 Percent as Firm Outlines Future MDx-Driven Growth

This story has been updated from a previous version to include information provided by BioMérieux during an investors event.

NEW YORK —BioMérieux reported on Tuesday that its first quarter revenues grew approximately 7 percent year over year driven by growth in BioFire and microbiology sales.

In addition, in an investors event the firm laid out a five-year growth plan that includes launching new multiplex test panels for its BioFire FilmArray and SpotFire molecular diagnostic systems.

For the three-month period ended March 31, BioMérieux's consolidated revenues rose to €965.2 million ($1.05 billion) from €905.7 million in the first quarter of 2022. At constant exchange rates and scope of consolidation the firm's revenues increased approximately 10 percent.

The Marcy l’Étoile, France-based firm "delivered an extremely strong performance, demonstrating the relevance of its solutions to meet medical needs," Pierre Boulud, CEO of BioMérieux, said in a statement. An overall 14 percent growth in BioFire panel sales and the "promising" launch of the SpotFire system "illustrate the continuous development of the syndromic approach," Boulud said, adding that the microbiology franchise continued to perform "remarkably well" as well.

"This strong quarterly performance represents a solid cornerstone to reach our 2024 financial objectives," Boulud said.

Revenues for the company's clinical applications segment grew 8 percent in the quarter to €818.8 million from €760.4 million in the year-ago period. Within that segment, molecular biology sales, which include the BioFire portfolio, rose 16 percent to €409.6 million from €352.7 million.

BioFire non-respiratory panel sales were up 19 percent at constant exchange rates and scope of consolidation, with respiratory panel sales increasing 12 percent. The installed base of BioFire systems increased by 300 units in the quarter, BioMérieux said, bringing the total installed base to about 25,700. SpotFire rapid point-of-care molecular system sales were €20 million in Q1, with an installed base increase of more than 400 units, bringing the total to approximately 1,200 units.

Microbiology sales were up 5 percent to €314.2 million from €299.6 million led by Vitek automated ID/AST and BACT/ALERT blood culture reagents. Revenues from immunoassays, meanwhile, were down approximately 13 percent to €83.3 million from €95.6 million related in part to continued decline in procalcitonin testing.

Industrial application sales during the first quarter rose approximately 1 percent year over year to €146.5 million from €145.4 million, which the firm said was fueled by high-single-digit sales growth in reagents.

By geography, the Americas accounted for 52 percent of total sales, growing 10 percent to €502.3 million from €455.4 million. Sales in North America grew 10 percent to €442.5 million from €402.7 million, while sales in Latin America grew approximately 14 percent to €59.9 million from €52.7 million.

In Europe, the Middle East, and Africa, sales grew 6 percent to €303.5 million from €287.6 million, while sales in the Asia Pacific region declined 2 percent to €159.4 million from €162.7 million.

In the quarter, BioMérieux obtained 510(k) clearance from the US Food and Drug Administration and CLIA waiver for the BioFire SpotFire Respiratory/Sore Throat (R/ST) Panel, which detects 15 bacteria and viruses in 15 minutes.

BioMérieux confirmed its 2024 guidance for organic sales growth between 6 percent and 8 percent. 

Five-year plan

At a Capital Markets Day event on Tuesday, BioMérieux executives laid out a plan to achieve 7 percent annual organic sales growth through 2028 driven by a combination of sales of BioFire non-respiratory panels and SpotFire, as well as growth in its microbiology and industrial applications business units.

In its presentation to investors, BioMérieux said pandemic sales overall resulted in a 50 percent increase in its profitability, with a 23 percent increase in its instrument installed base. BioFire systems in particular saw a 2.5x increase in installed base, the firm said.

BioMérieux delivered roughly five new instruments and 10 new assays between 2020 and 2023. In slides accompanying its presentation, the company noted that between 2024 and 2028 it plans to launch more and also to enter new markets.

Within its molecular biology business unit, BioMérieux said it expects to expand the menu for both the FilmArray and SpotFire systems over the next five years.

For FilmArray, the firm said it expects 10 percent or higher sales growth annually for its non-respiratory panels while anticipating flat sales for its respiratory panels. Currently two-thirds of customers use two FilmArray panels, nearly half use three panels, and about one quarter use four panels, BioMérieux said.

The firm also plans to launch a tropical fever panel in 2025 and a mid-plex gastrointestinal panel in 2026, as well as to update its meningitis and encephalitis panel in 2027. It also expects to bring the FilmArray system to applied markets, launching VetFire along with an equine respiratory panel in 2025, BioFire WatchFire for wastewater and environmental surveillance in 2026, and forensics testing in 2027.

Noting that the CLIA-waived molecular point-of-care testing market grew from about €400 million to €3.8 billion between 2019 and 2023, BioMérieux said its market analysis suggests POC MDx will be a €4.2 billion market by 2028.

The firm expects to expand into this market with the SpotFire system, 1,200 of which were placed in seven countries through March. The system is also distributed in the US in part through an agreement with McKesson.

The firm plans to reach €450 million in cumulative SpotFire sales by 2028 in part by targeting integrated delivery networks and large hospitals using its entire US sales team and by targeting independent POC settings through McKesson. The firm will also expand sales in Japan and launch in 10 additional countries.

The SpotFire 15-target respiratory and sore throat (R/ST) panel was cleared and CLIA waived last month, and the firm has previously launched 15-plex and five-plex SpotFire respiratory panels. The R&D pipeline includes a mini version of the R/ST panel this year, followed by a vaginitis panel in 2026, a meningitis and encephalitis panel in 2027, as well as panels to detect gastrointestinal and sexually transmitted infections in 2028.

Within the microbiology business unit, BioMérieux said it expects to achieve 6 percent to 8 percent annual organic growth through 2028 by cross-selling its full portfolio, leveraging the Vitek MS Prime MALDI-TOF mass spectrometry identification system and Vitek Reveal, and launching new reagents and instruments.

Specifically, the firm said it will add a Gram-negative blood culture assay to the Vitek Reveal in 2024, and a Gram-negative blood culture test in 2027, unlocking an approximately €40 million opportunity. It also expects to launch three instruments: the Vitek Compact Pro in 2024, the Vitek Pro in 2026, and a next-generation BACT/Alert 3D system in 2027.

BioMérieux said it is a niche player in the immunoassay space, but plans to maintain share in developed settings with its Vidas 3 system, and grow share in developing settings with Vidas Kube and a menu of more than 100 assays.

Finally, the firm expects 7 percent to 9 percent annual organic sales growth by 2028 in its industrial applications business unit. It plans to accelerate growth in food safety and quality control through the 1,000 unit installed base of its Gene-Up system and also to extend into the adjacent markets of food allergen and contaminant testing, either organically or through M&A. The firm also recently announced a partnership with the US FDA to develop new food-borne pathogen detection tools.

BioMérieux also highlighted its recent partnership with Oxford Nanopore Technologies and investments in Proxim Diagnostics and SpinChip, noting that its longer-term focus includes point-of-care immunoassay testing from capillary blood, liquid biopsy and central nervous system testing, next-generation  and whole-genome sequencing, metagenomics, and proteomics.