NEW YORK (GenomeWeb) – Belgian molecular diagnostics firm Biocartis today reported that its full-year 2018 revenues rose 32 percent year over year, driven by instrument adoption in the US and European markets.
Biocartis also announced this morning that it had received CE-IVD marking for the Idylla MSI Test, which was previously available as a research-use only test called Idylla MSI Assay launched last July.
For the 12 months ended Dec. 31, 2018, Biocartis' total revenues rose to €27.8 million ($31.7 million) from €21 million in 2017.
Total products sales rose 46 percent to €18.8 million from €12.9 million, driven by higher Idylla cartridge sales. Within total product sales, commercial revenues rose 40 percent to €17.8 million from €12.7 million a year earlier, while R&D revenues soared to €1 million in 2018 from €187,000 in 2017.
Collaboration revenues rose 8 percent to €8.3 million in 2018 from €7.7 million in 2017. Service revenues jumped 127 percent to €639,000 from €282,000 due to the firm's increased customer base.
Biocartis installed 326 Idylla instruments during the year, bringing its total installed base to over 970. Subsequent to the end of 2018, the firm's installed base rose to over 1,000 instruments.
The company said it sold 133,000 Idylla cartridges during the year, an 87 percent year-over-year increase which it attributed to the first year of successful commercialization in the US. The company also noted it completed a joint venture with Wondfo for the Chinese market, and a commercialization partner for the Japanese market.
On a conference call with analysts following the release of earnings, Biocartis CEO Herman Verrelst said that the firm is now seeking a 510(k) clearance from the US Food and Drug Administration for the Idylla MSI assay after receiving CE-IVD marking.
Biocartis' net loss for the year rose to €48.2 million, or €.94 per share, from a net loss of €42 million, or €.93 per share, in 2017.
R&D spending in the year dropped 7 percent to €36.8 million in 2018 from €39.6 million in 2017. The firm's SG&A costs climbed 27 percent year over year €23.3 million from €18.4 million.
At the end of 2018, Biocartis had cash and cash equivalents of €63.5 million. The firm also announced in January that it had completed a €55.5 million equity raise.
"Driven by our first full year of commercialization in the US, as well as a strong continued performance in our European and [rest of the world] markets, we managed to significantly expand our customer base and to further ramp up our commercial cartridge volume in 2018," Verrelst said in a statement.
In 2019, the firm expects new installations of around 350 Idylla instruments, bringing the total installed base to over 1,300. The firm is also targeting a commercial volume of between 210,000 and 225,000 Idylla cartridges.
In addition, Biocartis will expand internally by focusing on developing assays related to targeted therapies, immunotherapy, and liquid biopsy-based monitoring applications. The firm also plans to collaborate with external partners who own validated and high-value oncology gene signatures that can be used with the Idylla instrument.
"During 2019, we anticipate to further strengthen our assay menu for colorectal and lung cancer and to gear up for important assay launches in 2020," Verrelst said in Biocartis' statement.
Biocartis also announced this morning that it has appointed Piet Howen as the firm's chief operating officer, effective in April.