Biovica International (BIOVIC) Q3 24/25 earnings summary

Executive summary

• DiviTum TKa, a blood-based test for cancer monitoring, achieved FDA 510(k) clearance, Medicare price approval, and expanded clinical utility in both metastatic and adjuvant breast cancer, supported by over 30 clinical trials and peer-reviewed publications.

• Major agreements signed with US healthcare giants and insurance providers, expanding commercial reach to over 10 million policyholders and aiming to establish DiviTum as standard of care.

• Commercial coverage expanded to 17 European markets, including a new partnership with Eurobio Scientific, covering 60% of key markets.

• Collaboration with Outcomes4Me targets over 250,000 cancer patients to boost awareness and adoption.

• CLIA lab certification now covers all US states, including New York, enabling full US market access.

Financial highlights

• Q3 net sales reached SEK 2,261 thousand, doubling year-over-year, with May–Jan net sales at SEK 6,287 thousand, nearly SEK 1 million higher than the previous year.

• Q3 revenue grew 150% year-over-year and 2% sequentially from Q2, with US IVD sales for Q3 at SEK 2,046 thousand.

• Operating loss improved to SEK -22,183 thousand from SEK -27,848 thousand year-over-year due to higher sales and cost reductions.

• Cash flow improved by SEK 7.3 million year-over-year, with cash and cash equivalents at SEK 43,508 thousand at period end.

• Directed share issue and warrant exercises raised SEK 35.8 million before costs.

Outlook and guidance

• Pharma services pipeline expected to reach SEK 25 million by fiscal year-end, doubling since the start of the year.

• Anticipated launch of a modified FDA-cleared test for the adjuvant setting and extension of DiviTum TKa as an LDT test from the CLIA Lab.

• Ongoing efforts to achieve NCCN guideline inclusion and secure a companion diagnostic project with a tier one pharma company.

• Liquidity is expected to be sufficient until summer 2025, with active evaluation of financing options for the next twelve months.

• Focus remains on expanding the customer base and improving cash flow, with optimism for continued growth.