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MEDEXUS PHARMS INC (MEDXF) is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. The company focuses on therapeutic areas such as oncology, hematology, rheumatology, auto-immune diseases, allergy, and dermatology. Recent achievements include the approval of IXINITY for pediatric patients under 12 years of age with hemophilia B and the acceptance of treosulfan's New Drug Application for review by the FDA. MEDXF is dedicated to enhancing patient care and quality of life through its products.
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.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) held its virtual annual meeting of shareholders on September 19, 2024. Shareholders elected all nominated directors and approved the appointment of PricewaterhouseCoopers LLP as auditors. The election results showed strong support for all nominees, with approval rates ranging from 98.66% to 99.02%. The directors elected include Ken d'Entremont, Harmony Garges, Benoit Gravel, Michael Mueller, Stephen Nelson, Nancy Phelan, and Menassie Taddese. The appointment of auditors received 99.32% approval. A detailed report of the voting results will be filed with Canadian securities regulatory authorities and will be available on www.sedarplus.com.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) announced that the FDA has extended the review period for the New Drug Application (NDA) for treosulfan by three months. The new PDUFA target action date is set for January 30, 2025. This extension is due to the FDA requiring additional time to review supplemental analyses of previously submitted data, which they determined constitutes a major amendment.
The treosulfan NDA seeks approval for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients with acute myeloid leukemia and myelodysplastic syndromes. Despite the delay, Medexus remains optimistic and continues to prepare for a potential approval and commercial launch in the first half of 2025.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) reported fiscal Q1 2025 results with revenue of $27.3 million, a 13.6% decrease from Q1 2024. The company achieved net income of $2.0 million, up from $0.7 million in Q1 2024, and Adjusted EBITDA of $6.1 million. Key highlights include:
- Strong performance of Rupall during allergy season
- FDA acceptance of treosulfan NDA resubmission, with decision expected by October 30, 2024
- Positive cash flow and record quarterly operating cash flow of $8.2 million
- Implementation of cost reduction initiatives
- Ongoing negotiations with medac regarding treosulfan agreement
The company faces challenges with IXINITY and Rasuvo sales but remains optimistic about treosulfan's potential in the US market, targeting a commercial launch in the first half of 2025.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has announced a conference call scheduled for August 8, 2024, at 8:00 am Eastern Time to discuss the company's financial results for the first fiscal quarter ended June 30, 2024. The company plans to file its financial statements and MD&A after market close on August 7, 2024.
Investors can participate in the call using the provided toll-free numbers for Canadian and U.S. callers, or the international number. A live webcast will be available on Medexus's corporate website. A replay of the call will be accessible until August 15, 2024, and a webcast replay will be available until August 8, 2025.
Medexus Pharmaceuticals reported record revenue of $113.1 million for fiscal year 2024, a 4.6% increase from $108.1 million in 2023. This growth was driven by full recognition of Gleolan sales and strong demand for Rupall, offset by declines in IXINITY and Rasuvo sales.
Revenue for Q4 2024 was $26.0 million, down 9.1% from $28.6 million in Q4 2023. Adjusted EBITDA hit a record $19.5 million for the year, a 20.9% increase. However, Q4 2024 Adjusted EBITDA decreased to $4.4 million from $4.8 million in Q4 2023.
Operating income for the year was $10.8 million, but Q4 saw a decrease to $0.8 million. The company reported a net loss of $0.2 million for fiscal year 2024 and net income of $0.8 million for Q4 2024. Cash and cash equivalents were $5.3 million as of March 31, 2024, down from $13.1 million the previous year.
The FDA has accepted Medexus's partner medac's resubmission for treosulfan's NDA, with a decision expected by October 30, 2024.
Medexus Pharmaceuticals (TSX: MDP, OTCQX: MEDXF) has announced it will host a conference call at 8:00 am Eastern Time on Wednesday, June 26, 2024, to discuss its fourth fiscal quarter and fiscal year results ending March 31, 2024. The financial statements and MD&A will be filed after markets close on June 25, 2024. Interested parties can join the call via toll-free numbers for Canadian and U.S. callers or through an international number with the access code 160589. A live webcast will be available on Medexus's investor section of their website. A replay will be accessible approximately one hour post-call and until July 3, 2024, through specified phone numbers and on the website until June 26, 2025.
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