NEW YORK (GenomeWeb) – Curetis today reported a 36 percent year-over year increase in revenues for the first half of 2018, largely due to sales of its diagnostic test cartridge and instruments in Europe, the Middle East, and Asia.
For the six-month period ended June 30, Curetis' revenues rose to €807,000 ($919,553) from €595,000 a year earlier. Contributing to the growth was a 257 percent surge in sales from cartridges and instruments in the EMEA market.
Following US Food and Drug Administration 510(k) clearance in April, Curetis launched the PCR-based Unyvero System and the Unyvero LRT Application Cartridge for lower respiratory tract infections in June. Since the launch, the firm has qualified more than 125 accounts as potential buyers of Unyvero out of a total of about 1,000 hospitals it was targeting as potential customers of the LRT cartridge.
Earlier this month, Curetis expanded its presence into Northern Africa and Latin America by inking distribution agreements for its assays in the markets. With these partnerships in place, the firm now has 16 distribution partners covering 29 countries.
After completing an undisclosed pharmaceutical partner's phase III clinical trial in Q1 2018, Curetis bought back multiple Unyvero systems deployed in the clinical trial. This has led to a re-deployment of Unyvero analyzers, resulting in a temporary decrease in the installed base to 162 analyzers, down from the 175 at year-end 2017, the firm said.
However, Curetis expects to offset the decrease through future US sales and the entry into different EMEA markets, as well as additional distribution partnerships.
Curetis' H1 net loss rose to €11.6 million or €0.73 per share, from € 9.7 million, or €0.61 per share, in the year-ago period
R&D spending in the half-year rose about 47 percent to €4.7 million from €3.2 million a year earlier, while administrative costs rose about 17 percent to €2.1 million from €1.8 million year over year. In January, Curetis and MGI signed R&D and supply agreements focused on Curetis' Unyvero Lysator technology and instruments.
At the end of June, Curetis had cash and cash equivalents totaling €11.6 million.
In April, Curetis launched the CE-IVD marked Unyvero Urinary Tract Infection Application Cartridge, which covers 103 diagnostic targets. In addition, the Singapore Health Sciences Authority approved the firm's Unyvero HPN and BCU Application Cartridges.
Moving forward, Curetis aims to convert a US and EMEA pipeline of commercial opportunities for Unyvero into near-term deal closures and revenue contribution. The firm said it will expand existing collaborations, increase its international distribution network, and enter R&D and commercial partnerships centered around the Unyvero platform.
In addition, in order to expand the claim of its recently FDA-cleared Unyvero LRT Application cartridge, Curetis will file for clearance of bronchoalveolar lavage as a second sample type in the second half of 2018. Curetis is working toward a China market clearance for its Unyvero HPN Application Cartridge alongside Beijing Clear Biotech to explore how CE-IVD and FDA data could help accelerate the CFDA approval process.
Meanwhile, in July Curetis' subsidiary Ares Genetics launched its Antibiotic Resistance Solutions by Cooperative R&D (ARES & CO) pharma partnering program, which aims to establish an alliance for antibiotic stewardship with pharmaceutical companies and contract research organizations. Going forward, Ares will also enter into and expand existing R&D and commercial partnerships around ARESdb, its database of antimicrobial-resistant organism genetics, and the ARES platform.
Separately today, Curetis announced that Christopher Bernard has resigned as CEO and president of Curetis USA. In his place, Curetis has appointed Chris Emery as CEO and president of Curetis USA, effective Sept. 1, 2018.
Curetis also said that it will assess all tactical and strategic financing options in the debt and equity capital markets globally to raise additional growth capital as either equity or debt in 2018 in order to fund continued operations for at least the next year.