Medexus Pharmace - MEDXF STOCK NEWS

Medexus Pharmaceuticals (MEDXF) reported strong fiscal Q3 2025 results with revenue of $30.0 million, representing a 19.0% increase from the previous year. The company achieved net income of $0.7 million and Adjusted EBITDA of $5.8 million, an 81.3% year-over-year increase.

Key developments include FDA approval of GRAFAPEX in January 2025, with commercial launch expected by April 2025. Management believes GRAFAPEX has potential to exceed $100 million in annual revenue within five years post-launch. The company completed a public offering in January 2025, raising C$30 million in gross proceeds.

Notable product performance includes strong growth in Rupall and Trecondyv, while IXINITY showed stable demand. The company's available liquidity increased to $8.4 million as of December 31, 2024, up from $5.3 million in March 2024.

Medexus Pharmaceuticals (MEDXF) has successfully completed listing agreements with Ontario's Ministry of Health and Ontario Health for Trecondyv (treosulfan for injection). This enables public reimbursement through Ontario Public Drug Programs for eligible claims, marking a significant milestone following the pCPA negotiation process.

The company is now focused on securing similar reimbursement agreements with other provincial, territorial, and federal government organizations across Canada. This development follows the recent FDA approval of GRAFAPEX (treosulfan) for Injection in the US market, highlighting the expanding potential of Medexus's treosulfan products in North America.

Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has announced its upcoming third fiscal quarter 2025 conference call, scheduled for Thursday, February 6, 2025, at 8:00 am Eastern Time. The company will discuss financial results for the quarter ended December 31, 2024, with financial statements and MD&A expected to be filed after market close on February 5, 2025.

The call will be accessible via toll-free numbers for Canadian and U.S. callers (888-506-0062) and international callers (+1 973-528-0011) using access code 571655. A live webcast will be available on Medexus's corporate website's Investors section. A replay will be accessible until February 13, 2025, through dedicated phone numbers, and the webcast recording will remain available until February 6, 2026.

Medexus Pharmaceuticals announces FDA approval of GRAFAPEX (treosulfan), an alkylating agent used with fludarabine for allogeneic hematopoietic stem cell transplantation in AML or MDS patients. The drug holds Orphan Drug Designation, providing up to 7.5 years of regulatory exclusivity.

The company targets commercial launch in first half of 2025, projecting annual product-level revenue to exceed $100 million within five years. A $15 million regulatory milestone payment to medac GmbH will be made in installments: $2.5M by June 2025, $5M by October 2025, and $7.5M by January 2026.

Preliminary Q3 2025 estimates show revenue between $29.5-30.5 million (17% YoY increase), Adjusted EBITDA of $5.5-6.0 million (70% YoY increase), and operating income of $3.5-4.0 million (123% YoY increase). The company reports $8.5 million in available liquidity as of December 31, 2024.

Medexus Pharmaceuticals (MEDXF) has secured a listing agreement with British Columbia's Provincial Health Services Authority for Trecondyv (treosulfan for injection) to be included on the BC Cancer Benefit Drug List. This agreement enables public reimbursement for eligible patients using Trecondyv in combination with fludarabine as conditioning treatment before allogeneic hematopoietic stem cell transplantation in adult patients with acute myeloid leukemia or myelodysplastic syndromes who are at increased risk for standard conditioning therapies.

This marks the first reimbursement milestone following the successful completion of the pCPA negotiation process. Medexus is actively working with other provincial, territorial, and federal government organizations to expand public reimbursement coverage across Canada. The company views this development as an important indicator of the product's potential in both the Canadian market and potentially the US market, pending FDA approval.

Medexus Pharmaceuticals has amended its US treosulfan licensing agreement with medac, establishing new regulatory milestone payments tied to FDA approval. The payment structure varies based on product labeling: US$15 million for basic approval, US$20 million for non-inferiority, or US$45 million for clinical superiority. Payments will be made in three installments: one-sixth by June 2025, one-third by October 2025, and the remaining 50% by January 2026. The company expects FDA approval by January 30, 2025, projecting potential annual US revenue exceeding US$100 million within five years post-launch.

Medexus Pharmaceuticals has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for Trecondyv (treosulfan for injection) on November 4, 2024. This milestone follows positive reimbursement recommendations from Quebec's INESSS and Canada's Drug Agency in March 2024. Currently, about 75% of Canadian transplant centers are using treosulfan, with unit demand growth of 49% over the 12-month period ended September 30, 2024. The next phase involves individual government organizations making final decisions on public reimbursement in their regions.

Medexus Pharmaceuticals reported fiscal Q2 2025 results with revenue of $26.3 million, net income of $0.1 million, and Adjusted EBITDA of $6.0 million. Revenue decreased 13.2% year-over-year due to reduced sales of Rasuvo and IXINITY. Despite revenue decline, Adjusted EBITDA increased 13.2% to $6.0 million, driven by financial discipline and improved IXINITY manufacturing costs. The company reduced debt by $7.5 million and maintains $7.0 million in available liquidity. Medexus is preparing for potential treosulfan US launch in 2025, estimating potential annual revenue exceeding $100 million within five years post-launch.

Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has scheduled a conference call for November 8, 2024, at 8:00 am Eastern Time to discuss its second fiscal quarter results ending September 30, 2024. The company will release its financial statements and MD&A after market close on November 7, 2024. The call will be accessible via toll-free numbers for Canadian and U.S. callers, with international dial-in options available. A live webcast will be hosted on Medexus's corporate website, with replay access available until November 8, 2025.