Biovica - Ticking the boxes for a 2021 launch
Successful clinical validation and 510(k) submitted Fully funded for DiviTumTKa launch in 2021 Next up: Commercial partnership and FDA clearance Preparations for US market launch of DiviTumTKa Biovica submitted the FDA 510(k) application for DiviTumTKa in September. While COVID-19 led to the FDA reallocating resources and delaying the process, Biovica expects the FDA to start the substantive review during Q1’21. This implies a potential 510(k) clearance and US launch in Q2’21. The US product reimbursement is currently ongoing to secure clinical usage and uptake.
This includes evidence development, guideline inclusion, engaging payers and reviewing coding, pricing and payment structures. Biovica still aims to secure its first US product reimbursement in 2021 and target the first EU5 and Nordic launch in late 2021. A key foundation for the commercialization process builds on strong scientific collaborations, where Biovica now has clinical results from 14 studies involving more than 2,300 breast cancer patients.
As we previously reported, we are encouraged by the four clinical studies that will be presented at the SABCS 2020 on December 8-11. SEK 148m directed share issue adds solid cash runway In August, Biovica conducted a directed share issue raising gross proceeds of SEK 148m, creating a more than two-year financial runway. This leaves the company fully funded for its ongoing commercialization efforts.
The company maintains its ambitious financial targets, with a 15% market share in the metastatic breast cancer (MBC) opportunity (~SEK 500m-890m sales) by 2024. The longer-term ambition is to claim a 50% market share in each market, translating to sales of ~SEK 1. 7bn-3bn, and the company notes that DiviTum’s initial focus on MBC will only be addressing ~1% of all the people living with cancer.
No surprises in the FYQ2’20/21 report As expected, Biovica generated no revenue in Q2’20/21; operating cash flow came in at SEK -8. 5m (vs. SEK -7.
4m in Q1’20/21) wit.
