Q1’22/23 EBIT of SEK -21m, cash position of SEK 72m
510(k) clearance the big news in the quarter
The Q1’22/23 report included limited surprises: the FDA’s already-announced decision to give 510(k) clearance for Biovica’s DiviTum was the big news during the quarter. The clearance was based on clinical data from the SWOG study, where it achieved a negative predictive value (NPV) of 96.7%, which means that a measured TKa value with DiviTum below the threshold (250 DuA) with 96.7% accuracy indicates that the patients are not progressing. We believe this could have a clinical value to oncologists, to confirm that a patient is responding to the treatment.
Path forward towards market launch
The focus for Biovica is now to make DiviTum commercially available, something it aims to achieve before the end of this year. This mainly entails setting up and CLIA certifying its own commercial laboratory in San Diego, where it will also conduct a smaller analytical validation of its assay. It will also go through administrative tasks, such as validating a logistics process and billing system before it will conduct a launch campaign. Biovica is currently refining its go-to-market plan, but it has highlighted NCI and NCCN affiliated centers as a customer group it will target initially. Following the US launch, it seeks to launch in Europe by Q1’23.
Q1’22/23 financials
Biovica reported Q1’22/23 sales of SEK 0.5m (Q1’21/22 SEK 0.4m), attributable to sales to research customers. EBIT decreased to SEK -20.7m (SEK -12.2m) as it is establishing its own laboratory and ramping up the organisation ahead of the launch of DiviTum. The cash position was SEK 72m (SEK 131m), which exceeds the firm’s capital needs for the upcoming 12 months.
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