Organogenesis Holdings Inc. Q4 FY2024 earnings call

• Revenue for Q4 was above the high end of guidance, growing 27%.
• LCD finalization was delayed, affecting market disruption. The MACs announced a second delay to April 13, 2025.
• ReNu program: Completed Phase 3 trial enrollment in 2024, with interim analysis in Q4, expecting top-line data in Sept 2025 and BLA submission by end of 2025.
• Financial results: Q4 net revenue $126.7M, up 27%; GAAP net income $7.7M. Balance sheet: $136.2M in cash, no debt.
• Strategic focus: Investing in clinical data to enhance sales and reimbursement dynamics.

In the fourth quarter, Advanced Wound Care net revenue was $119 million, up 27%, contributing a significant portion. Surgical and Sports Medicine products had net revenue of $8 million in Q4, up 24%. For the year ended December 31, 2024, net revenue increased to $482 million from $433.1 million in 2023. Advanced Wound Care products saw a $48.1 million (12%) increase, and Surgical & Sports Medicine products had a $0.8 million (3%) increase.

• 2025 net revenue guidance: $480M to $535M (roughly flat to 11% increase year-over-year).
• Advanced Wound Care: $450M to $500M (decline 1% to increase 10% year-over-year).
• Surgical & Sports Medicine: $30M to $35M (increase 6% to 23% year-over-year).
• GAAP net income range: $9.5M to $38.8M; EBITDA range: $27M to $66.6M; non-GAAP adjusted net income: $15.3M to $44.6M; adjusted EBITDA: $43.6M to $83.2M.
• Assumes LCD effective date of April 13, 2025, with first half challenging and stabilization in third quarter.

• Market disruption due to delays in LCD implementation, causing ambiguity in customer behavior.
• Uncertainty in reimbursement changes affecting product adoption and sales.
• Competitive dynamics in the wound care market, including potential share gains by competitors.

Q: Please describe what you're seeing in the marketplace from competitors and customer buying behavior amid LCD delays.

A: Dave Francisco mentioned no major change in competitive environment, but customer buying behavior is affected by reimbursement dynamics; customers pause and test reimbursement with longer shelf-life issues for living technologies.

Q: Update on RCTs for products not on covered list.

A: Gary S. Gillheeney, Sr. stated PuraPly study expects interim analysis in Q4 2025 and publication in Q1 2026, with expectation of reconsideration by MACs by Q1 2026.

Q: Discussion on LCD expectations and product conversion risk.

A: Gary S. Gillheeney, Sr. stated LCD is likely to be implemented in April, with conversion of products in back half of 2025 showing stronger business trends; significant market share available, including non-DFU and VLU uses of covered products.