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, with operating income of $10.8M and a modest net loss of $0.2M; Q4 2024 revenue was $26M, down 9.1% year-over-year, with adjusted EBITDA of $4.4M and net income of $0.8M.

• Revenue growth was driven by full-year Gleolan sales and strong Rupall demand, partially offset by IXINITY and Rasuvo declines.

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

• Leadership changes include new CFO and COO appointed, effective June 2024, to support future growth.

• FDA accepted Treosulfan NDA for review, with a decision expected by October 30, 2024; potential US launch in first half of 2025.

Financial highlights

• Full-year revenue increased by $5M (4.6%) year-over-year to $113.1M; Q4 revenue was $26M, down 9.1% year-over-year.

• Gross profit for the year was $59.5M, with a gross margin of 52.6%.

• Adjusted EBITDA rose to $19.5M for the year, up from $16M in fiscal 2023; Q4 Adjusted EBITDA was $4.4M, down 8.8% year-over-year.

• Operating income for fiscal year 2024 was $10.8M, up 42.1%; Q4 operating income was $0.8M, down 69.6% year-over-year.

• Available liquidity at year-end was $5.3M, with $18.7M cash provided by operating activities in fiscal 2024.

Outlook and guidance

• No significant revenue from treosulfan expected until early fiscal 2026; FDA review expected to conclude by October 30, 2024, with US commercial launch targeted for first half of 2025.

• Modest investments in personnel for treosulfan launch ahead of potential FDA approval by October 30, 2024.

• Operating expenses expected to remain relatively stable, with new investments offset by cost savings.

• Quarterly debt payments of about $3.3M planned to continue reducing outstanding BMO credit facilities.

• Rupall expected to face generic competition in Canada after exclusivity expires January 2025.