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Biocartis H1 2018 Revenues Jump 83 Percent

NEW YORK (GenomeWeb) – Belgian molecular diagnostics firm Biocartis today reported that its total revenues for the first half of 2018 jumped 83 percent year over year, driven by a rise in cartridge consumption and collaboration revenue.

For the six months ended June 30, Biocartis' total revenues soared to €12.7 million ($14.8 million) from €7.0 million in 2017.

Total product sales rose 69 percent to €8.6 million from €5.1million, driven by a 102 percent jump in Idylla cartridge sales to €6.6 million from €3.3 million a year earlier. Within total product sales, commercial revenues rose 58 percent to nearly €8.0 million from €5.0 million a year earlier, while R&D revenues skyrocketed to €605,000 in 2018 from €66,000 in 2017.

Collaboration revenues, meanwhile rose sharply to €3.5 million in H1 2018 from €716,000 in H1 2017. Service revenues rose more than 141 percent to €251,000 from €104,000.

The company installed 149 Idylla instruments during the recently completed period, bringing its total installed base to 796, and sold about 58,000 cartridges.

In July, Biocartis launched its microsatellite instability (MSI) assay as a research-use-only test, which provides information on the status of a tumor in about 2.5 hours from just one slice of FFPE tumor tissue without requiring a reference sample. Running on the Idylla platform, the assay includes a set of seven biomarkers, including ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2 genes.

On a conference call with analysts following the release of the earnings, Biocartis CEO Herman Verrelst said that each of the markets it is active in contributed to the firm's growth in the first half of the year.

In the US, Verrelst highlighted that the firm significantly increased its user base in H1 2018 in a variety of different-sized lab environments with "approximately one-third of the [H1] installed base [coming] from the US."

In a statement, he noted that the firm is "doing well in Europe ... due to an increased usage of Idylla in first-line testing in key [markets] such as the UK, France, and Germany ... and we saw a strong overall contribution from our pharmaceutical collaborations."

In addition, Verrelst said that Biocartis has obtained market authorizations in Argentina, Brazil, Canada, Malaysia, Mexico, Singapore, and Uruguay in 2018.

Biocartis' loss for the first half of 2018 dropped to €21.8 million, or €0.42 per share, from €24.0 million, or €0.54 per share, in H1 2017.

The company's R&D spending in the first half of the year dropped 17 percent year over year to €16.0 million in 2018 from €19.3 million in 2017. Its SG&A costs increased 36 percent to €11.0 million from €8.1 million.

At the end of the first six months of 2018, Biocartis had cash and cash equivalents totalling €91.3 million.

Earlier this week, Biocartis announced that it is forming a joint venture with Guangzhou, China-based point-of-care testing firm Wondfo to commercialize the Idylla platform in China. In the short term of the partnership, Biocartis will focus on local manufacturing as well as commercialization of the Idylla platform with the Chinese FDA.

Last month, Biocartis announced that it had an exclusive license for EGFR ectodomain mutations that have been shown to determine responses to targeted metastatic colorectal cancer therapy.

In January, Biocartis partnered with Immunexpress to accelerate commercialization of the firm's Septicyte assay on the Idylla platform. In addition, Biocartis has partnered with Amgen to develop CDx biomarkers on the platform for a compound that Amgen is developing to treat certain solid tumors.

Biocartis said that for 2018 it is now guiding to the high end of a targeted range of 250 to 275 new Idylla instruments, which would bring its total base to around 925 instruments. Biocartis also expects commercial cartridge consumption to double year-over year to nearly 144,000 cartridges.

Biocartis plans to expand its list of test menu options and anticipates receiving CE marking for the Idylla colorectal cancer MSI assay in Q1 2019. Partnering with Amgen, Biocartis aims to apply for premarket approval from the US Food and Drug Administration for the Idylla RAS test in Q1 2019.

For its lung cancer menu, Biocartis has decided to no longer seek CE marking for its solid biopsy BRAF Mutation Test. Instead, it aims to add the mutation to a larger lung cancer panel covering multiple genes.

In addition, Biocartis will launch its Idylla Resistance monitoring menu in H2 2019, it said.

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