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Curetis 2018 Revenues Grow 17 Percent

NEW YORK (GenomeWeb) – Curetis said today that its full-year 2018 revenues grew 17 percent year over year.

For the 12 months ended Dec. 31, 2018, the molecular diagnostics development firm reported revenues of €1.4 million ($1.6 million), up from €1.2 million in 2017.

The company said its R&D costs grew 43 percent year over year to €10.6 million from €7.4 million while its administrative costs were up 8 percent to €4.1 million from €3.8 million, and its distribution costs rose 12 percent to €8.2 million from €7.3 million.

The company, which is headquartered Holzgerlingen, Germany, posted a loss of €24 million, or €1.41 per share, in 2018 compared to a loss of €19.3 million, or €1.26 per share, in 2017.

Curetis exited 2018 with €10.3 million in cash and cash equivalents.

Company highlights last year included clearance by the US Food and Drug Administration of the firm's Unyvero platform and the Unyvero LRT multiplex assay to detect lower respiratory tract infections. In October the firm also said that it secured €20 million in growth capital through the issuance of convertible notes.

However, the company cut 30 percent of its workforce as part of a strategic restructuring and currently has about 95 employees as of the beginning of the second quarter of 2019, it said.

"Reprioritizing several R&D programs and a more partnering-driven strategy should allow us to reduce cash burn significantly in 2019," Curetis CEO Oliver Schacht said in statement today. "In light of available financial resources and funding for Curetis, we have also made the strategic decision to streamline our European commercial operations by moving from a direct sales model in key European markets toward an external distribution model in 2019. With A. Menarini Diagnostics, we have found an ideal partner to execute this strategy."

Curetis and A. Menarini announced last month an exclusive long-term strategic distribution partnership.

Looking ahead, the company anticipates that "multiple" customers will buy the Unyvero LRT assay during this year, and the number of installed Unyvero A50 Analyzers in the US is expected to grow to between 30 and 40 systems from 15 in 2018 "with a continuously growing number of analyzers starting to generate revenues as commercial accounts in" the second half of 2019.

The global installed base of Unyvero A50 Analyzers is expected to grow to more than 200 by the end of this year from 167 at the end of 2018, Curetis said, and total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million in 2019.

The company said it intends to submit to FDA for 510(k) clearance an additional Unyvero LRT application cartridge for use with bronchoalveolar lavage samples in mid-2019. Clearance of the product could come in the second half of the year, it said.

If a suitable partner is found, Curetis also said that it may be able to finalize the development and clinical trials for the Unyvero IJI Application Cartridge for invasive joint infections in the US and to file with the FDA for marketing of the product. Meanwhile, in China, the firm's partner, BCB, is anticipated to complete its submission of the Unyvero HPN Cartridge for the detection of pathogens that cause pneumonia for approval by regulators there. A submission to the National Medical Products Administration was initially filed in February, but further steps may be required by Chinese regulators, Curetis said.