Integra LifeSciences (IART) CL King's 22nd Annual Best Ideas Conference 2024 summary

Compliance Master Plan and quality initiatives

• Launched a comprehensive Compliance Master Plan to standardize quality systems and address audit and regulatory findings, with implementation over the next 18 months.

• Created a new board committee focused on quality and operations, increasing management and board oversight.

• Increased investments in manufacturing facilities to enhance quality, resilience, and capacity for long-term growth.

• Compliance Master Plan may uncover further corrective actions, potentially impacting supply, but aims to strengthen controls and reduce future disruptions.

• Incremental resources for compliance will impact gross margins during the plan's execution.

Supply chain, shipping holds, and operational updates

• Shipping holds in neurosurgery are being resolved on a product and country basis, with most expected to be lifted in Q3 and residual impact in Q4.

• 2025 outlook factors in potential for additional supply disruptions as compliance efforts continue.

• No current knowledge of shipping holds of the same magnitude as 2023-2024, but ongoing compliance work could reveal new issues.

Manufacturing and facility transitions

• Transitioning SurgiMend and PriMatrix manufacturing to a new Braintree facility, with operationalization targeted for the first half of 2026.

• Major milestone is getting the new site operational, with equipment installation and system validation underway.

• FDA inspection required for PMA products before full approval; 510(k) products can resume distribution once validated.