AxoGen (AXGN) investor relations material

Regulatory and market exclusivity

• Achieved Biologic License Approval (BLA) with a broad label, allowing continued service for all nerve discontinuities, including sensory, motor, and mixed nerves.

• The label is agnostic to application and establishes the product as a safe and effective biologic for nerve discontinuities.

• Holds 12 years of market exclusivity as a reference product, with significant practical barriers for competitors to enter the market.

• Nerve care is gaining credibility and becoming a standard part of care pathways, contributing to exclusivity.

Insurance coverage and reimbursement

• Commercial insurance coverage increased from 50% to 64%, with three major insurers pending; all technical requirements for coverage have been satisfied.

• Formal submissions for reconsideration have been made, with responses expected throughout the year based on payers' review cycles.

• CMS reimbursement for outpatient settings increased by about 40% after successful advocacy, with a dedicated nerve code established.

• Most nerve care remains inpatient, but the improved outpatient payment may shift some procedures over time.

Market development and growth strategy

• Years of growth anticipated, focusing on expanding both hospital footprint and practitioner education.

• High potential account strategy targets Level I and II trauma centers, prioritizing locations with high acuity, academic affiliation, and prior nerve care experience.

• Market development now follows a rigorous, textbook approach to achieve standard of care status, emphasizing education, coverage, and payment.