Organogenesis Holdings Inc. Q3 FY2024 earnings call

• Revenue results: Delivered sales above the high end of the guidance range in Q3 with improving momentum. - Strategic initiatives: Announced additional clinical results from the first Phase 3 trial meeting primary endpoints; completed enrollment in the second Phase 3 trial ahead of schedule with favorable interim analysis; made progress in clinical validation and Medicare reimbursement for products like NeuShield, PurePly AM and XT; engaged with CMS on payment policies. - RENEW program: Completed enrollment in the second Phase 3 trial, on track for BLA submission by end of Q4 2025 if successful.

Net revenue for the third quarter was $115.2 million, up 6%. Advanced wound care net revenue for the third quarter was $108 million, up 7%, and net revenue from surgical and sports medicine products for the third quarter was $7 million, up 1%. Gross profit for the third quarter was $88 million, or 76.7% of net revenue compared to 76.2% last year. Operating expenses for the third quarter were $82.1 million compared to $74.7 million last year, with selling, general and administrative expenses up 12% year-over-year, while research and development expenses declined 1% year-over-year and 34% sequentially.

• 2024 net revenue guidance updated to $455 million to $480 million, up 5%-11% year-over-year. - Advanced wound care net revenue expected to be $429 million to $452 million, up 6%-11% year-over-year. - Surgical and sports medicine products net revenue expected to be $26 million to $28 million, with a range of -6% to +1% year-over-year change. - GAAP net loss guidance: $12.3 million to $0.6 million. - Adjusted EBITDA guidance: $31.7 million to $47.4 million.

• Potential disruption from the implementation of LCDs which could impact market dynamics. - Uncertainties related to clinical trial timelines and outcomes. - Changes in Medicare payment policies that could affect product coverage and access.

Q: Ross Osborne asked about the broadening of the salesforce and the number of reps focused on sports med.

A: Dave Francisco said they increased rep count, with under 20 reps focused on sports med.

Q: Ryan Zimmerman inquired about the fourth quarter impact of LCDs and RENEW program timeline.

A: Dave Francisco discussed limited impact in Q3 and the range for Q4 due to LCD uncertainty; Gary Gillheeney mentioned last patient, last visit in RENEW program completed, with interim analysis in Q4 and BLA submission in Q4 2025.