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Medexus Announces Fiscal Q1 2026 Results, Including Positive Results from US Launch of GRAFAPEX (treosulfan) for Injection
Newsfileยท 2025-08-12 21:30
Core Insights - Medexus Pharmaceuticals reported fiscal Q1 2026 results, highlighting a net revenue of $24.6 million and a net income of $0.5 million, with a focus on the successful launch of GRAFAPEX [1][2][8] Financial Performance - Fiscal Q1 2026 net revenue was $24.6 million, a decrease of $2.7 million or 9.9% compared to $27.3 million in fiscal Q1 2025, primarily due to reduced sales of Rupall and Gleolan [9] - Adjusted EBITDA for fiscal Q1 2026 was $3.4 million, down $2.7 million or 44.3% from $6.1 million in fiscal Q1 2025 [9] - Operating income decreased to $0.9 million, a drop of $3.1 million or 77.5% compared to $4.0 million in fiscal Q1 2025 [9] - Available liquidity as of June 30, 2025, was $9.3 million, down from $24.0 million as of March 31, 2025, mainly due to a $15.5 million payment under a credit agreement [9] GRAFAPEX Performance - GRAFAPEX generated $3.0 million in product-level net revenue during fiscal Q1 2026, matching the investment in personnel and infrastructure for the product [3][12] - The company anticipates GRAFAPEX's product-level net revenue for fiscal Q2 2026 to be between $3.0 million and $3.5 million, considering observed wholesaler purchasing patterns [5][12] - GRAFAPEX is expected to contribute positively to quarterly operating cash flows by fiscal Q3 2026 [5][12] Market Response and Future Outlook - Positive market response to GRAFAPEX includes formulary inclusion by nine large commercial payers covering approximately 48 million patient lives [5] - The US Centers for Medicare & Medicaid Services approved New Technology Add-On Payment (NTAP) reimbursement for GRAFAPEX, which will provide additional reimbursement starting October 1, 2025 [11] - The company expects annual product-level net revenue from GRAFAPEX to exceed $100 million within five years post-launch [11] Product Portfolio and Competitive Landscape - The company is facing challenges with Rupall, which has seen a 29% decrease in unit demand due to the expiration of market exclusivity and increased generic competition [17] - Other products like Trecondyv and IXINITY have shown varying performance, with Trecondyv experiencing a 38% growth in unit demand over the past year [13][14]