Kuros Biosciences (KURN) investor relations material

Strategic direction and growth

• Achieved first-time profitability in 2025 with 72% revenue growth to $146.1M, $19.6M adjusted EBITDA, $2.6M net profit, no debt, and $19.8M in cash.

• Advanced from #9 to #3 in U.S. biologics market, with MagnetOs now the third largest synthetic bone graft brand by revenue and direct sales up 71% year-over-year.

• Expanding from spine into foot & ankle, trauma, and oncology, with methodical market entry and clinical trials.

• Opened new U.S. headquarters and manufacturing in Alpharetta, Georgia, supporting future capacity and dual-site manufacturing with the Netherlands.

• Business transformation includes dual production footprint, digitalization, and supply chain optimization to support scalable growth.

Clinical evidence and innovation

• Invests in Level I clinical trials for MagnetOs, exceeding regulatory requirements and demonstrating higher fusion rates than autograft (79% vs. 47% at 1 year).

• Ongoing Level I studies: PROOF, PRECISE (spine), and ASTRA (foot & ankle), with robust enrollment and readouts expected after full enrollment and one-year follow-up.

• Product innovation pipeline includes MagnetOs MIS Delivery System, new fleXmatrix sizes, settable bone void fillers, and future antibiotic-eluting variants.

• Next-gen products focus on faster bone growth, precision delivery, and expanded U.S. indications based on surgeon feedback.

• Human biopsy and histological data reinforce clinical efficacy and predictability of bone formation.

Commercial strategy and market expansion

• Building specialized sales and education teams for extremities and trauma, leveraging surgeon peer education and dedicated marketing initiatives.

• Secured large hospital contracts, MDR approval for EU sales beyond 2027, and Medtronic partnership to expand U.S. spine market reach.

• Contribution margins in extremities expected to exceed spine, supporting EBITDA margin growth.

• Focused on methodical, evidence-driven adoption and sustainable market penetration, with addressable U.S. opportunities in spine, foot & ankle, and trauma totaling over 2 million procedures annually.

• Adoption driven by clinical evidence, economic value, and favorable regulatory pathways in the UK/EU.