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Biocartis Reports 35 Percent 2019 Revenue Rise, New Bristol-Myers Squibb CDx Project

NEW YORK – Belgian molecular diagnostics firm Biocartis reported on Thursday that its full-year 2019 revenues rose nearly 35 percent year over year, driven by a global adoption of its Idylla instrument and cartridges.

Biocartis also said that it has partnered with Bristol-Myers Squibb to register its Idylla MSI test as a companion diagnostic in China.

For the 12 months ended Dec. 31, 2019, Biocartis' revenues jumped to €37.4 million ($41.9 million) from €27.8 million in 2018.

Product sales rose about 29 percent to €24.2 million from €18.8 million, including €18 million from Idylla cartridge sales, up from €14.7 million in 2018, and €6.2 million from Idylla system sales, up from €4.2 million in 2018. Within total product sales, commercial revenues increased nearly 29 percent to €22.9 million from €17.8 million a year earlier, while R&D revenues rose 36 percent to €1.4 from €1 million in 2018.

Collaboration revenues rose 49 percent to €12.5 million in 2019 from €8.3 million in 2018, driven by R&D services. Service revenues rose 20 percent to €769,000 from €639,000 in 2018.

Biocartis installed 337 Idylla instruments during the year, bringing its total installed base to 1,310.

The company said it sold about 175,000 Idylla cartridges in 2019, about a 32 percent year-over-year increase, which it attributed to adoption in the European and rest of the world (ROW) markets.

Biocartis' net loss for the year rose to €64.1 million, or €1.14 per share, from a net loss of €48.2 million, or €.94 per share, in 2018.

R&D spending in the year rose 8 percent to €39.8 million from €36.8 million in 2018. The firm's SG&A costs jumped 38 percent year over year to €32.2 million from €23.3 million.

At the end of 2019, Biocartis had cash and cash equivalents of €178.7 million.

Under the new agreement with Bristol-Myers Squibb, the partners will pursue registration of the Idylla MSI assay as a companion diagnostic in China. The companies have an existing collaboration agreement to register the assay in the US as a companion diagnostic for immunotherapies in metastatic colorectal cancer, which Biocartis CEO Herman Verrelst noted at the JP Morgan Healthcare Conference in January. 

Biocartis also inked a master collaboration agreement with AstraZeneca in January to show how the Idylla platform can reduce the complexity and long turnaround time of biomarker testing for lung cancer patients. The agreement will initially focus on evaluating if liquid biopsy testing using the Idylla ctEGFR Mutation Assay — launched in October — could provide further benefits to tissue-based EGFR molecular testing.

Biocartis also noted that CFO Ewoud Welten resigned from the firm in January and that it is in the process of recruiting a new CFO. Moving forward, the firm said it will have a limited executive management team composed of a CEO, CFO, and chief operational officer.

In 2020, Biocartis expects new installations of around 300 to 350 Idylla instruments, bringing the total installed base to over 1,600. The firm is also targeting a commercial cartridge volume of about 228,000 Idylla cartridges.

"Our 2020 outlook is driven by a strong Q4 2019, our sizeable installed base, our new US go-to-market strategy announced in September 2019, a good outlook for Europe and RoW, as well as the menu expansion realized in 2019 through the CE-marking of our Idylla MSI Test and launch of our Idylla ctEGFR mutation assay," Verrelst said in a statement. "In addition, toward [the] end 2020, we expect to see important new assay launches … and we expect our first oncology US [Food and Drug Administration] filing."