Keenova Therapeutics (MNK) Q3 2025 earnings summary

Executive summary

• Completed the merger of Mallinckrodt and Endo on July 31, 2025, forming Keenova Therapeutics, and spun off generics and sterile injectables as Par Health, with Keenova now focused on specialty brands and Par Health on generics and sterile injectables.

• Keenova targets rare and unmet medical needs across multiple therapeutic areas, leveraging a strong U.S. manufacturing base and global reach.

• New leadership appointments, including a new CFO and Chief Scientific Officer, have strengthened the executive team.

• Keenova plans to pursue a NYSE listing and public offering in 2026, subject to board approval and market conditions.

• Fiscal year-end changed to December 31, resulting in five additional operating days in 2025.

Financial highlights

• Q3 2025 net sales were $753.1M, up 49% year-over-year, driven by the Endo acquisition and Acthar Gel growth; Keenova's pro forma net sales were $480M, up 10% year-over-year.

• Acthar Gel net sales grew 44% to $181M; XIAFLEX net sales rose 2% to $130M; INOmax net sales fell 8% to $59M.

• Adjusted EBITDA for Q3 2025 was $111.3M, down from $160.6M in Q3 2024, impacted by $123.3M in merger compensation expenses; pro forma adjusted EBITDA for Keenova was $129M, up 5% year-over-year.

• Gross profit was $254.0M (33.7% of net sales), with gross margin down from 43.7% year-over-year.

• Cash and cash equivalents at quarter-end were $1,047.9M, with net debt of $2,657.0M.

Outlook and guidance

• Full-year 2025 pro forma net sales expected between $1.87B and $1.89B; adjusted EBITDA between $480M and $515M, including $135M in merger-related compensation expenses.

• Raised 2025 full-year net sales growth guidance for Acthar Gel to 30%-35%; XIAFLEX net sales growth guidance updated to mid-single digits.

• Q4 2025 net sales expected at $485M-$505M; adjusted EBITDA at $155M-$165M.

• On track to realize $75M in pre-tax run-rate synergies in the first 12 months post-merger and at least $150M annually by year three.

• Management expects continued integration costs and potential volatility as the business transitions post-separation.