Earnings Call Summary | Organogenesis(ORGO.US) Q1 2024 Earnings Conference
Earnings Call Summary | Organogenesis(ORGO.US) Q1 2024 Earnings Conference
The following is a summary of the Organogenesis Holdings, Inc. (ORGO) Q1 2024 Earnings Call Transcript:
以下是Organogenesis Holdings, Inc.（ORGO）2024年第一季度業績電話會議記錄摘要：
Financial Performance:
財務業績：
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.
Organogenesis Holdings公佈的第一季度淨收入爲1.1億美元，比上年增長2％。
高級傷口護理淨收入爲1.039億美元，增長3％。
外科和運動醫學產品的淨收入略有下降9％，達到610萬美元。
毛利增至8,130萬美元，相當於淨收入的73.9％。
第一季度的營業虧損和淨虧損分別減少至390萬美元和210萬美元。
Business Progress:
業務進展：
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.
ReNU的III期臨床試驗取得了重大進展，該產品旨在控制膝蓋骨關節炎症狀。
試驗數據顯示，膝關節 OA 疼痛顯著減輕，患者功能得到改善，安全性分析成功。
戰略性地提高了與客戶的互動，從而振興了現有客戶並推動了整體增長。
該公司的兩款產品Apligraf和Affinity已進入擬議的LCD醫療保險報銷保障清單。
Organogenesis繼續開發臨床驗證數據，以確保其他產品的覆蓋範圍。
2024年的財務指導預計淨收入在4.45億美元至4.7億美元之間，表明同比增長3％至9％。
該公司將捆綁支付系統視爲有效控制和管理市場的必要舉措。實施只能在 2026 年或之後進行。
對於ReNU產品，ORGO預計將在5月底之前完成數據分析，並在8月初與美國食品藥品管理局舉行會議。他們預計將在9月份公佈結果。
根據一項或兩項研究的批准要求，它們的目標是在26年第二季度（兩項研究）或25年（一項研究）提交BLA，相應的預計批准和商業化分別在27年或26年的第二季度。
More details: Organogenesis IR
更多詳情： 器官發生紅外
Tips: For more comprehensive details, please refer to the IR website. The article is only for investors' reference without any guidance or recommendation suggestions.
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譯文內容由第三人軟體翻譯。