The following is a summary of the Organogenesis Holdings, Inc. (ORGO) Q1 2024 Earnings Call Transcript:
Financial Performance:
Organogenesis Holdings reported Q1 net revenue of $110 million, an increase of 2% from the previous year.
Advanced Wound Care net revenue was $103.9 million, a growth of 3%.
Net revenue for Surgical and Sports Medicine products saw a slight decrease of 9%, bringing it to $6.1 million.
Gross profit increased to $81.3 million, which is equivalent to 73.9% of net revenue.
Both operating loss and net loss for the first quarter reduced to $3.9 million and $2.1 million respectively.
Business Progress:
Significant advancements were seen in the Phase III clinical trial for ReNu, a product designed to manage knee osteoarthritis symptoms.
The trial data exhibited a significant reduction in knee OA pain, improved patient functioning, and successful safety profiling.
A strategic increase in engagement with customers led to revitalizing existing customers and driving overall growth.
Two of the company's products, Apligraf and Affinity, made it to the proposed LCD covered list for Medicare reimbursement.
Organogenesis continues to develop clinical validation data to secure coverage for other products.
Financial guidance for 2024 projects net revenue between $445 million and $470 million, indicative of a 3% to 9% increase in year-over-year growth.
The company views the bundled payment system as an essential move to control and manage the market effectively. The implementation may only take place in 2026 or later.
For the product ReNu, ORGO expects to complete data analysis by the end of May and have a meeting with FDA in early August. They anticipate revealing the results by September.
Depending on the requirement of one or two studies for approval, they aim at BLA submission in Q2 of '26 (two studies) or '25 (one study), with a corresponding anticipated approval and commercialization in Q2 of '27 or '26 respectively.
More details: Organogenesis IR
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