The main news from the report was the timeline and path forward for approval and sales start of DiviTum. The revised 510(k) filing was submitted on 28 April and Biovica has received an indication that the FDA has started to review it. The normal review time is 90 days: Biovica expects a decision during calendar Q3, which will either be a clearance or a request for more information. Simultaneously it is establishing the CLIA lab where the facility is in place (evident in the higher right-of-use liability) and is now working to get it certified, a process that should be smoother than the 510(k). The company guided for sales start in calendar Q4, with key commercial personnel already in place.
DiviTum shown complimentary to ctDNA at ASCO
The BioItaLEE study was presented at ASCO, the world’s largest cancer conference. The study included 287 breast cancer patients receiving ribociclib and letrozole as first-line treatment and ctDNA and TK activity (with DiviTum) was measured for 241 patients. The results showed that baseline measurement and patterns throughout treatment were prognostics for treatment for both biomarkers. Measuring TKa and ctDNA were complimentary. Given the hype surrounding the latter, we believe it opens new possibilities on how to position DiviTum.
Q4 financials and estimate revisions
We revise our assumptions for the sales ramp-up and given a sales start in Q4 there will only be a couple of months of sales in FY’22/’23e with the first full year thereafter. This is reflected in our new sales estimates of SEK 8m, 42m and 80m until FY’24/’25e. Higher sales to research customers drove SEK 1.1m (0.3m) in net sales in Q4. EBIT was SEK -19.1m (-12.2m) on increasing opex, which we expect to continue to increase as it closes in on commercialisation. The cash position was SEK 90m and management sees ...
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