Core Viewpoint - Celularity Inc. welcomes the withdrawal of the Local Coverage Determinations (LCDs) for skin substitute products by the Centers for Medicare & Medicaid Services (CMS), which were set to take effect on January 1, 2026, while ensuring that its Biovance® and Biovance 3L products remain eligible for Medicare coverage [1][2] Group 1: CMS Actions - On December 24, 2025, CMS announced the immediate withdrawal of LCDs for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, which would have affected coverage starting January 1, 2026 [2] - The withdrawn LCDs eliminated Medicare coverage for 158 skin substitute products from other companies, while Celularity's products remained unaffected [2] Group 2: Company Insights - Dr. Robert J. Hariri, CEO of Celularity, highlighted the substantial real-world evidence supporting the effectiveness of Biovance® in treating chronic wounds across diverse patient populations [3] - Biovance® has shown a reduction in steroid use in about 50% of treated patients, which may help decrease pro-inflammatory factors and enhance the body's natural healing process [3] - The new Medicare payment policy, effective January 1, 2026, will reimburse skin substitute applications at a flat rate of $127.28 per square centimeter, which Celularity is prepared to operate under due to its efficient manufacturing process [3] Group 3: Company Overview - Celularity Inc. is focused on developing, manufacturing, and commercializing advanced biomaterial products and cell therapies derived from postpartum placenta, addressing significant unmet needs in regenerative medicine [4] - The company aims to leverage the unique biology of the placenta to create effective and affordable therapies targeting aging mechanisms such as cellular senescence and chronic inflammation [4]

Core Viewpoint - Celularity Inc. reported significant growth in net revenues for the year ending December 31, 2024, totaling $54.2 million, which represents an increase of $31.4 million or 138.1% compared to the previous year, driven primarily by strong sales in wound care applications [1][3]. Financial Performance - Net revenues for 2024 were $54.2 million, an increase of $31.4 million or 138.1% from the prior year, with product sales in wound care applications rising by $22.2 million, reflecting a growth of 168.7% [1][3]. - Total operating expenses decreased to $92.6 million, down by $122.5 million or 57.0% compared to 2023, mainly due to the absence of goodwill and in-process research and development impairments [4][6]. - Loss from operations for 2024 was $38.4 million, a decrease of $153.9 million or 80.1% from the previous year, attributed to higher revenues and lower operating expenses, which improved gross margin [4][6]. Product and Market Development - The company experienced strong sales growth in its Biovance® product line, which is expected to continue contributing positively to revenue in the upcoming quarters [2]. - Celularity received recommendation letters from the U.S. FDA Tissue Reference Group for new additions to its portfolio of human placental-derived advanced biomaterial products, indicating a commitment to innovation in the wound care sector [2]. Balance Sheet Overview - As of December 31, 2024, total assets were $132.7 million, a decrease from $143.9 million in 2023, with current assets amounting to $20.6 million [8][9]. - Total liabilities increased to $123.8 million from $102.9 million in the previous year, with current liabilities at $53.7 million [8][9]. Company Background - Celularity Inc. is focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies, aiming to address significant unmet global needs for effective and affordable therapies [10].