Medexus Pharmaceuticals (MDP) Q3 2025 earnings summary

Executive summary

• Fiscal Q3 2025 delivered stable revenue growth, positive net income, and strong adjusted EBITDA, supporting preparations for the U.S. launch of GRAFAPEX by April 2025.

• FDA approval of GRAFAPEX (treosulfan for injection) in January 2025, with orphan drug designation and at least seven years of exclusivity; commercial launch targeted for first half of 2025 and significant revenue contribution expected from fiscal 2026 onward.

• Completed a CAD 30 million public offering in January 2025, strengthening liquidity and supporting growth initiatives and regulatory milestones.

Financial highlights

• Q3 2025 revenue was $30 million, up 19% year-over-year; nine-month revenue was $83.6 million, down 4% due to lower sales of Rasuvo, Metoject, and IXINITY, partially offset by gains in Rupall and Gleolan.

• Adjusted EBITDA reached $5.8 million in Q3, up 81.3% year-over-year; nine-month adjusted EBITDA was $17.9 million, up 18.5%.

• Net income was $0.7 million in Q3 and $2.8 million for the nine months, a significant improvement from prior year losses.

• Operating income was $3.8 million in Q3.

• Available liquidity increased to $8.4 million at December 31, 2024.

Outlook and guidance

• GRAFAPEX commercial launch in the U.S. targeted for first half of 2025, with product availability by April and annual revenue potential exceeding $100 million within five years post-launch.

• Rupall in Canada faces generic competition following exclusivity expiry in January 2025, with anticipated price reductions.

• Guidance suggests future revenues may revert to previous quarters' levels after a strong Q3, especially for IXINITY; IXINITY US unit demand expected to remain stable through March 2025.