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Biovica: Prolonged FDA review times - ABG

Abnormal FDA review times impacting 510(k) clearance
Prospective trial TK IMPACT initiated
Q2’/21/22 EBIT of SEK -14.3m and cash of SEK 118m

Progression towards getting 510(k) clearance for DiviTum, which will enable sales in a clincal setting, is in the hands of the FDA. Discussions are ongoing, but formal feedback is taking longer than usual; this is the current limiting factor for the process. Once the FDA decides that it requires no additional information, a decision should be given within 30 days (interactive review), but considering the extended review times during the pandemic, we see a risk that it could take longer. The prolonged clearance process has also impacted discussions with a commerical lab partner, as they would like to see a progression towards market clearance before signing an agreement.

Q2’21/22 revenues were SEK 0.3m (vs. SEK 0.04m in Q2’20/21). Operating expenses increased to SEK 15.3m (11.8m) on the back of the expansion of the US organization, while EBIT was SEK -14.3m (-8.3m). The cash position at the end of the quarter was SEK 117.9m (162.4m), and is expected to finance operations for the coming two years.
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