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]

Core Insights - The US Centers for Medicare & Medicaid Services (CMS) has approved New Technology Add-On Payment (NTAP) for GRAFAPEX™ (treosulfan) for Injection for fiscal year 2026, which runs from October 1, 2025, to September 30, 2026 [2][3] - GRAFAPEX™ will receive a maximum NTAP reimbursement of $21,411 for eligible cases, identified by specific ICD-10-PCS codes [2] - This approval is significant as GRAFAPEX™ was one of only five technologies approved for NTAP out of 13 applications considered by CMS [2] Company Developments - Medexus Pharmaceuticals has seen a positive response to GRAFAPEX™ since its US commercial launch in February 2025, with nine large commercial payers covering approximately 48 million patient lives making positive formulary inclusion determinations [3] - As of June 30, 2025, 37 out of 180 transplant centers in the US have ordered GRAFAPEX™ for procedures, indicating strong initial uptake and demand [3] - The company continues to work on expanding GRAFAPEX™'s market presence, with additional commercial payers adding it to their prior authorization lists [3] Product Information - GRAFAPEX™ is indicated for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) [6] - The product holds Orphan Drug Designation, providing it with a seven-year period of regulatory exclusivity in its FDA-approved indication [6] - Efficacy data from a clinical trial showed a hazard ratio for overall survival of 0.67 compared to busulfan, indicating a significant clinical improvement [8]