The company has added another dimension to its go-to-market strategy, establishing a CLIA certified lab in San Diego, USA. A CLIA certification is a prerequisite to perform clinical samples, so this move allows the company to target clinicians at hospitals directly. While this strategy will likely incur higher headcount in sales and the lab, there are potential benefits to gaining direct access clinical decision-makers, such as feedback and opportunities to enhance the product. Biovica has selected a property and hired key staff, and it expects certification in Q3’22. This also opens the opportunity to offer DiviTum as a laboratory-developed test (LDT), which is an alternative regulatory pathway to 510(k).
510(k) process moving forward – uncertainty decreasing
The FDA gave feedback on the 510(k) process in February, with most questions resolved. However, Biovica has to supplement the analytical validation, which it believes it can do by May of this year. If that closes the substantive review, potential clearance could be seen in June or July. The review time has been negatively affected by higher FDA workload during the pandemic, as the agency has paused the review of non-critical IVD-tests other than COVID-19. In response, the FDA has increased its capacity, and as the pandemic burden decreases, so will the uncertainty.
Estimate changes and Q3’21/’22 financials
We update our estimates, reflecting potential 510(k) clearance in July and a slower ramp-up and higher near-term opex following the evolved US go-to-market strategy. We now forecast sales of SEK 45m for the first year of launch (FY‘22/’23e), with 74m the year after. Q3’21/’22 sales were SEK 0.3m (Q3’20/’21 SEK 1.4m), largely in line with recent quarters, while EBIT decreased to SEK -14.4m (SEK -10.9m) on headcount incre
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