Biovica had their road show presentations for Pareto clients this week. The company reconfirmed that it is in an active talks with FDA which they believe should conclude with the FDA approval by Q3. Our base case (based on discussion with analysts) is June/July. Biovica is meanwhile preparing for the US sales lunch. The impressive US sales team was presented at their Investor Day presentation.
Best Biovica CEO quotes from the presentation yesterday:
“FDA is developing really well… We are confident to get our FDA clearance in Q3….. The last time we communicated with the FDA was last Friday…”
The Biovica presentation from the roadshow:
The impressive US sales team was presented at their Investor Day presentation.
Do watch their investor day presentation from 17 May – link below: https://fitinvestmentideas.com/2022/05/18/abg-summary-from-biovica-yesterdays-capital-markets-day/
ABG Sundal Collier Research Summary from 22/6/22:
Updated timeline for sales start
Updated timeline for sales start
FDA decision expected in Q3, potential sales start in Q4
DiviTum shown complimentary to ctDNA
Q4’21/22 EBIT of SEK -19m, cash position of SEK 90m
Updated sales start
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.
The full research is available for free here: https://cr.abgsc.com/contentassets/c19f4d31dbcf419b964b82c34fceb97d/pdf/updated-timeline-for-sales-start.pdf
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