Biovica: Closing in on the finish line - ABG

510(k) clearance feedback could be one month away
Appointment of President of the Americas
Q1’21/22 EBIT of SEK -12.2m and cash of SEK 130.9m

The 510(k) process that will open the US market for DiviTum continues to move forward. During the quarter, the company has interacted with the FDA and undergone a Submission Issue Request (SIR) process . This is a routine way for the FDA to resolve or clarify minor issues or questions that have arisen during a submission process. The company has compiled all the additional data and plans to send it to the FDA with an SIR in early September. The company expects that the FDA will provide feedback within 21 days, which means that a response should be received by the end of September. The response should lead to either: 1) a 510(k) clearance or 2) a request for additional data and a slight delay of the process (months)

Revenues for the quarter amounted to SEK 0.4m (vs. SEK 0.3m in Q1’20/21), relating to customers that use DiviTum for research purposes. Operating expenses increased to SEK 13.6m (10.7m), driven by an increase in FTEs and preparations for the anticipated DiviTum launch, while EBIT was SEK -12.2m (-8.6m). The cash position at the end of the quarter amounted to SEK 130.9m (31.4m) and is expected to suffice for commercialization in the US and Europe and two years of working capital.

Länk till analysen i sin helhet: https://www.introduce.se/foretag/Biovica/Equity-research/2021/9/biovica---closing-in-on-the-finish-line/https://www.introduce.se/foretag/Biovica/Equity-research/2021/9/biovica---closing-in-on-the-finish-line/