Biovica - US commercialisation around the corner
Expects commercial partner after 510(k) clearance in Q3 Adding to the organisation and health economic data Strong cash position and good cost control in Q4’20/21 Biovica remains confident for FDA 510(k) clearance in Q3’21 Biovica reiterates its timeline for potential 510(k) clearance of DiviTum for the US during Q3’21. Its ambition is to enter into an agreement with a commercial partner shortly after US clearance, and we forecast a revenue split of 50/50 with a US laboratory (such as LabCorp, Quest Diagnostics, Sonic Healthcare, BioReference etc. ). During the conference call, management highlighted that it expects to start with single non-exclusive commercial partnerships in the US and EU, with potential additional partners down the road.
Focus on increasing commercial readiness Biovica’s focus during the quarter was on increasing readiness ahead of the anticipated US launch of DiviTum, including expanding its management team. The company hired a commercial manger and a QA/RA manager, both of whom have extensive experience, including a history of successful medical product launches and completed 510(k) processes. Biovica also presented a budget impact model that can help assess potential cost savings from using DiviTum.
The model, which was presented at ISPOR 2021, is an important step to enlighten and educate clinicians and payers on the benefits from using DiviTum. We also note that the PROMIX study was published in the quarter, showing DiviTum’s prognostic value in locally advanced breast cancer, as a liquid biopsy option to the Ki67 biomarker commonly used for assessing breast tumour cell growth. Financials – cash position supporting commercialisation Revenues for the quarter amounted to SEK 0.
3m (vs. SEK 0m in Q4’19/30), relating to two new customers that use DiviTum for the development of new cancer treatments. Costs were higher, reflecting the additions to the management team, and EBIT was SEK -12.
1m (-10. 3m). For the full fiscal year net sales an.
