NEW YORK (GenomeWeb) – Curetis reported today a 9 percent decline in revenues for the first half of 2017, reflecting market volatility for its Unyvero molecular diagnostic system.
For the six-month period ended June 30, Curetis' revenues fell to €594,800 ($695,176) from €654,682 in the first half of 2016. The firm said that due to the uneven spread of early-stage instrument sales throughout the year, revenue volatility is expected quarter to quarter.
Curetis also said that the global installed base of Unyvero analyzers grew to 161 at the end of June — a nearly 43 percent increase over the 113 devices installed as of June 30, 2016. Additionally, the company said it received a bulk order for 18 analyzers from its US subsidiary last month, with another bulk order expected later this year.
In January, Curetis submitted the Unyvero instrument and a related lower respiratory tract (LRT) infection panel for approval to the US Food and Drug Administration. Pending a final clearance decision by US regulators, the company said it is maintaining its target for a global installed base of more than 200 Unyvero analyzers by year end.
Separately on Tuesday, Curetis announced that it signed an agreement to provide in-house testing services with its recently CE-marked Unyvero assay for severe intra-abdominal infections to German drugmaker Biotest. Financial terms of the deal were not disclosed, but Curetis said that it will provide microbial pathogen, toxin, and antibiotic resistance marker testing in a Phase IIb study of Biotest's Pentaglobin in patients with secondary peritonitis.
Curetis' net loss in the first half of 2017 swelled 45 percent to €9.7 million, or €.61 per share, from €6.7 million, or €.43 per share, in the same period last year.
The company's R&D spending fell slightly to €3.2 million from €3.3 million as the company awaits an FDA decision on its Unyvero system and LRT panel and prepares to launch a US multicenter clinical study of a Unyvero panel for invasive joint infections, which is expected to be fully enrolled in 2018. SG&A costs, meantime, climbed 60 percent to €6.7 million from €4.2 million, largely due to greater sales and distribution expenses.
At the end of June, Curetis had cash and cash equivalents totaling €25.4 million.
"In the first half of 2017, we continued to accelerate our corporate, commercial, and product development initiatives," Curetis CEO Oliver Schacht said in a statement. "Most notably, we are looking forward to a FDA decision on potential US clearance of the Unyvero Platform and LRT application for tracheal aspirates in late 2017. This decision is expected to be a key value inflection point for Curetis, and we have already begun establishing the foundation for an impactful US launch."
In line with its focus on a Unyvero rollout in the US, Curetis said that it plans to hire 20 additional US staffers in sales, applications, field service, and operations ahead of the expected FDA decision.
The company also disclosed today that CTO and Cofounder Andreas Boos is stepping down from his role on the management board to focus on his duties as CTO and program director for the firm's recently acquired Gyronimo qPCR platform. Chris Bernard, president and CEO of Curetis' US subsidiary, has also been appointed executive vice president of global sales, while COO Achim Plum has been named chief business officer.
In a statement, Schacht attributed the management changes to "the increasing commercial focus of the company."