GRAFAPEX (treosulfan) for Injection
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Medexus Announces Fiscal Q2 2026 Results, Driven by Strong Year-To-Date Product-Level Performance of GRAFAPEX (treosulfan) for Injection
Newsfile· 2025-11-12 23:06
Core Insights - Medexus Pharmaceuticals reported strong performance in fiscal Q2 2026, primarily driven by GRAFAPEX (treosulfan) for Injection, with product-level net revenue reaching $3.1 million and $6.2 million for the three- and six-month periods ended September 30, 2025, respectively [2][4][9] - The company experienced a decrease in overall net revenue, attributed to reduced sales of Rupall and Gleolan, but GRAFAPEX's performance is expected to positively impact future cash flows [4][5][6] Financial Performance - Total net revenue for fiscal Q2 2026 was $24.7 million, down 6.1% from $26.3 million in the prior year, while six-month revenue decreased by 7.8% to $49.4 million [4][5] - Adjusted EBITDA for the three- and six-month periods was $4.4 million and $7.8 million, representing a decrease of 26.7% and 35.5% year-over-year, respectively [5][6] - Operating income was reported at $1.4 million and $2.2 million for the three- and six-month periods, reflecting a decrease of 12.5% and 60.7% compared to the previous year [7] Product Performance - GRAFAPEX has shown strong market demand, with 83% of US transplant centers engaged and 29% having ordered the product [3][9] - The company anticipates that GRAFAPEX will exceed $100 million in annual product-level net revenue within five years post-launch, supported by recent NTAP reimbursement approvals [8][9] - Patient unit demand for Trecondyv increased by 69% over the trailing 12 months, while IXINITY saw a slight decrease of 3% [10][11] Operational Highlights - Medexus has successfully reduced total debt by $16.6 million since March 31, 2025, bringing total long-term debt to $21.1 million as of September 30, 2025 [6][7] - The company generated $3.3 million in cash flow from operating activities for fiscal Q2 2026, despite a decrease from the previous year [6][7] - GRAFAPEX's launch has been supported by significant investments in personnel and infrastructure, totaling $6.0 million through September 30, 2025 [2][3]
GRAFAPEX (treosulfan) for Injection Receives CMS Approval of New Technology Add-On Payment (NTAP) for Eligible Cases in CMS's Fiscal Year 2026
Newsfile· 2025-08-05 11:00
The NTAP program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies in the first few years after introduction to the market. To receive NTAP approval, designated technologies must demonstrate substantial clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives.^ Starting October 1, 2025, eligible procedures involving the use of GRAFAPEX™ will be eligible for additional reim ...