NEW YORK – Referring to its "unprecedented wave" of innovation in 2023, BioMérieux provided extensive updates on its product lines and strategies during a call with investors Thursday morning.
The French firm also briefly commented on its investment in Oxford Nanopore Technologies and disclosed a new investment in SpinChip, a Norway-based company developing a rapid point-of-care diagnostic system potentially capable of performing multiple types of lab testing.
Following the reporting of fourth quarter and full-year financial results, BioMérieux CEO Pierre Boulud and other executives highlighted uptake and sales growth potential for three newly launched systems: the BioFire SpotFire for rapid point-of-care molecular diagnostic testing, the Vitek Reveal for rapid antimicrobial susceptibility testing, and the Vidas Kube immunoassay system.
At a high level, BioMérieux's investment in and acquisition of novel diagnostic technologies has yielded strong results for the company over the years.
BioMérieux acquired BioFire in early 2014 for its FilmArray syndromic testing platform, and has expanded its installed base to more than 25,000 from around 700 since then.
BioMérieux began developing the BioFire SpotFire in 2016. The system is based on the same core technology as FilmArray but with souped-up chemistry and sample prep enabling a run time of 15 minutes, compared to FilmArray's 45 minutes.
Launched commercially about six months ago, SpotFire is now available in seven countries, and BioMérieux inked a deal with McKesson in November for US distribution.
SpotFire entered Q4 with 400 placements and exited 2023 with a cumulative installed base of double that amount. BioMérieux CFO Guillaume Bouhours said on the call that these 800 instruments generated €20 million in revenues in 2023 (about $21.6 million based on average exchange rates), €18 million of which was attributed to reagent sales. BioFire's total clinical applications sales for 2023 were €854.5 million.
Given this utilization rate and the expected ramp-up of installations, BioMérieux is targeting annual sales of €80 million for SpotFire in 2024 and is on track for €400 million in annual sales by 2027.
Installations are split, with 80 percent in a point-of-care setting and 20 percent in the hospital setting. Boulud said the firm is seeing growth in integrated delivery systems, as well, but noted that the purchasing process in IDS hospitals takes a bit more time. However, he added, "when they buy, they buy for multiple installations at once, and we're starting to see traction also in this segment."
Customers also appreciate that there are both five-plex and 15-plex respiratory panel options, Boulud said, as this maximizes the opportunity for clinicians to adapt testing to patients.
The firm submitted the SpotFire Respiratory/Sore Throat Panel to the US Food and Drug Administration in September. Boulud described respiratory and sore throat testing as "the two big components" where SpotFire needs to be present and said the firm expects the sore throat panel to garner regulatory approval in the US this year. Then, BioMérieux will be "in a very strong position to be very competitive in the market," he said. The firm expects to share more information regarding its SpotFire menu pipeline next month at an Investor Day event.
Regarding current competition in the point-of-care molecular testing space, Boulud cited Cepheid in particular. "They are very strong competitors, so we don't take them lightly," he said, adding that the Abbott ID Now and Roche Liat are also strong.
Vitek Reveal and Vidas Kube
The company purportedly dedicates three-quarters of its R&D funding to antimicrobial resistance, and acquired the Specific rapid technology because it could seamlessly integrate with its other solutions for sepsis and AST. After the acquisition, the phenotypic testing technology, called Specific Reveal, was awarded breakthrough device designation from the FDA and won a contract from BARDA to accelerate its development.
The Reveal system can provide an antibiogram from a positive blood culture within six hours and is modular to enable labs to scale according to their needs.
On its call with investors last year, BioMérieux executives projected that the Specific Reveal portfolio would reach $60 million in annual sales by 2027. Rebranded as the Vitek Reveal, executives said the company was preparing an FDA filing and anticipating US sales in 2024.
On the call Thursday, Boulud said the sales ramp for the product has been slower than expected in Europe. Furthermore, it was submitted to the FDA in April last year, yet remains in the FDA review process. Although these delays made 2023 revenues lower and will delay the breakeven projected for 2024, "we are still very confident in the value of the platform and its commercial potential," Boulud said.
Despite a large medical need for rapid AST, he said the slower-than-expected sales growth in Europe is related to the intensive technical validation required by hospitals as well as financing challenges, Boulud said.
"As we did with BioFire, we are creating and generating new market segments with fast AST," he said. "That today is not necessarily in the tender and the budget from the labs, so we're working on that."
Overall, the firm is confident Specific Reveal will bring value to BioMérieux, but "it's a long and complicated process, as we experienced also with syndromic testing."
And despite the delays, Boulud said the firm is seeing a positive "halo impact" on the rest of its microbiology range. The innovation of Vitek Reveal "rejuvenates interest" for its entire suite of microbiology products, he said, noting this effect is complicated to measure but supported by strong growth across the portfolio in 2023.
The Vidas Kube, meanwhile, also launched last year. This new platform can use the firm's other immunoassays in the Vidas line, including those for Vidas tests for emergency and critical care, immunochemistry, infectious diseases, food industry pathogens, and the new CE-marked traumatic brain injury assay. The commercial launch resulted in 400 instruments placed by the end of 2023, the firm said.
ONT, SpinChip investments
In April, BioMérieux entered a nonexclusive R&D agreement with Oxford Nanopore Technologies (ONT) to codevelop sequencing-based infectious disease applications.
In the results reported on Thursday, the firm said it made a strategic investment in ONT through the subscription of ordinary shares, equating to 3.5 percent of ONT's voting rights as of Oct. 13, 2023. In addition, on Oct. 19, 2023, BioMérieux completed the acquisition of a further 3.4 percent of ONT's shares on the secondary market for a total consideration of £68 million.
Bouhours said on the call that BioMérieux does not expect to increase its stake in ONT beyond 7 percent.
"We have regular contacts at the CEO, CFO, and R&D levels to follow both the R&D partnership as well as the overall Oxford situation, as we are one of their main investors," he said. Regarding a trend toward a decline in ONT's share price, Boulud added that this is not an issue for BioMérieux. "We invested in Oxford Nanopore with a more medium- to long-term perspective," he said.
On Thursday, BioMérieux also announced it acquired a minority stake in Norwegian immunoassay system developer SpinChip Diagnostics with an investment of NOK 115 million ($10.9 million), making it the second-largest shareholder at the Oslo-based company.
According to SpinChip's website, the core technology involves using dual axle centrifugation to drive microfluidics. The system currently performs immunoassays but is being developed to also run clinical chemistry, hematology, coagulation, and molecular diagnostics, according to that company's website.
While the initial focus for the investment will be a high-sensitivity cardiac troponin I to diagnose acute heart attacks, the firm plans to also develop additional cardiac and sepsis tests. Furthermore, it will develop a prototype high-sensitivity multiplex cartridge that will deliver three simultaneous test results.
"We've entered the point-of-care market with Spotfire, so we are very active at looking for opportunities to complement the portfolio in the point-of-care setting, and definitely beyond the molecular point-of-care solution," Boulud said. "We believe that we could nicely complement the portfolio with an obviously well-differentiated immunoassay point-of-care solution," he added.
Finally, regarding whether SpotFire may begin to cannibalize sales of the legacy FilmArray products, Boulud said that 80 percent of the SpotFire installations are in the point-of-care setting, and the SpotFire is being used for frontline testing while the FilmArray systems are deployed in second-line testing. "We are actually seeing more of a synergistic approach than cannibalization," he said.