Core Insights - Medexus Pharmaceuticals reported its operating and financial results for the third fiscal quarter ended December 31, 2025, highlighting the positive market response to GRAFAPEX and its expected contribution to future revenues [1][2][7]. Financial Performance - For fiscal Q3 2026, Medexus achieved net revenue of $25.3 million, a decrease of 15.7% year-over-year, primarily due to reduced sales of Rupall and the termination of the Gleolan license agreement [6]. - Adjusted EBITDA for the same period was $4.5 million, reflecting a decrease of 22.4% compared to the prior year, attributed to generic competition and the Gleolan agreement termination [6]. - Operating income was reported at $1.7 million, down 55.3% year-over-year, marking the third consecutive quarter of operating income growth since GRAFAPEX's launch [6]. GRAFAPEX Performance - GRAFAPEX generated product-level net revenue of $2.0 million and $8.2 million for the three- and nine-month periods ended December 31, 2025, with expectations of exceeding $100 million in annual revenue within five years [2][8]. - There was a 30% sequential increase in underlying patient demand for GRAFAPEX in fiscal Q3 2026 compared to fiscal Q2 2026, with a notable 56% increase in demand from adult hospitals [3][8]. - As of December 31, 2025, 32% of US transplant centers had ordered GRAFAPEX, with 77% of those institutions placing repeat orders [3][9]. Operational Highlights - The company has invested $8.5 million in GRAFAPEX's launch, which has significantly impacted its market performance [3][5]. - Medexus anticipates that GRAFAPEX will contribute positively to quarterly operating cash flows starting in fiscal Q4 2026, with expected product-level Adjusted Gross Margin of approximately 80% [8][9]. Corporate Developments - Medexus entered into a new credit agreement with the National Bank of Canada, providing a $21.0 million term loan facility and a $5.0 million revolving loan facility, enhancing its financial stability [12]. - The company has repurchased 191,900 common shares under its normal course issuer bid, reflecting its commitment to returning value to shareholders [12].

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]