Medexus Pharmaceuticals (MDP) Q4 2024 earnings summary

Executive summary

• Achieved record annual revenue of $113.1M and record adjusted EBITDA of $19.5M for fiscal 2024, up 4.6% and 20.9% year-over-year, with operating income of $10.8M and a modest net loss of $0.2M.

• Fiscal Q4 2024 revenue was $26M, down 9.1% year-over-year, with adjusted EBITDA of $4.4M and net income of $0.8M.

• FDA accepted Treosulfan NDA for review, with a decision expected by October 30, 2024, potentially enabling a US launch in early fiscal 2026.

• Leadership changes include new CFO and COO, aligning for future growth and US commercialization.

• Ongoing expense management initiatives contributed to improved financial results in Q4.

Financial highlights

• Full-year revenue increased by $5M (4.6%) year-over-year to $113.1M; Q4 revenue decreased by $2.6M compared to Q4 2023.

• Gross profit for Q4 and full year were $13.3M and $59.5M, with gross margins of 51.2% and 52.6%, respectively.

• Adjusted EBITDA for the year rose by $3.4M to $19.5M; Q4 Adjusted EBITDA was $4.4M.

• Operating income for fiscal year 2024 was $10.8M, up 42.1% year-over-year; Q4 operating income was $0.8M.

• Cash and cash equivalents at year-end were $5.3M, with $18.7M cash provided by operating activities in fiscal 2024.

Outlook and guidance

• FDA review of Treosulfan resubmission expected to conclude by October 30, 2024; significant revenue from Treosulfan not expected until early fiscal 2026.

• Modest investments in personnel for Treosulfan launch are underway, with further hiring contingent on FDA approval.

• Anticipates continued strong performance from Rupall and Metoject in Canada, but expects generic competition for Rupall after January 2025.

• Expects challenging demand and pricing environment for IXINITY and Rasuvo in the US due to market trends and regulatory changes.

• Topical terbinafine NDS under review by Health Canada, targeting commercial launch in first half of calendar 2025.