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Keenova Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Net sales from continuing operations for Q3 2026 were $550 million, an increase of $133 million (32%) compared to $416.1 million in Q3 2025.
    • Acthar Gel net sales reached $227 million, a 25% increase year-over-year.
    • XIAFLEX net sales were $164 million, driven by increased demand in Peyronie's disease and net price.
    • Loss from continuing operations was $96 million, an improvement from a $242 million loss in the prior-year period.
    • Adjusted EBITDA from continuing operations was $233 million, compared to $45.7 million in Q3 2025.
    • Nine-month 2026 net sales totaled $1,535.0 million, up 73% from $887.6 million in the prior-year period.
    • Nine-month 2026 loss from continuing operations was $430.1 million, compared to $347.8 million in the prior-year period.
    • Nine-month 2026 Adjusted EBITDA from continuing operations was $617.8 million, compared to $170.8 million in the prior-year period.
    • Cash and cash equivalents at September 30, 2026, were $1,085.6 million, up from $812.8 million at December 31, 2025.
    • Long-term debt stood at $2,511.7 million at September 30, 2026, down from $2,532.3 million at December 31, 2025.
    • Net cash provided by operating activities for the nine months ended September 30, 2026, was $290.0 million, compared to a use of $41.1 million in the prior-year period.
    • Capital expenditures for the nine months ended September 30, 2026, were $21.4 million.
  • Guidance and Future Outlook:

    • Keenova raised full-year 2026 pro forma net sales guidance to $2.00 billion to $2.025 billion, up from the previous range of $1.94 billion to $2.00 billion.
    • Full-year 2026 pro forma Adjusted EBITDA guidance was raised to $750 million to $770 million, up from the previous range of $715 million to $745 million.
    • The company reiterates full-year Acthar Gel net sales growth guidance of 20% to 22%.
    • The company raised full-year XIAFLEX net sales growth guidance to 10% to 11% year-over-year, up from high single-digit growth previously expected.
    • The company expects to realize approximately $110 million in pre-tax synergies in 2026.
    • The company remains on track to achieve $150 million in annual pre-tax run-rate synergies by the merger's three-year anniversary.
    • Guidance excludes the full-year contribution of Percocet and does not account for future acquisition or divestiture activity.
  • Business Segments and Product Lines:

    • Acthar Gel performance was driven by higher patient demand and commercial investments.
    • XIAFLEX performance was driven by increased demand in Peyronie's disease and net price.
    • INOmax net sales for Q3 2026 were $57.1 million, a 3% decrease from $58.9 million in Q3 2025.
    • Other products net sales for Q3 2026 were $83.2 million, a 5% increase from $79.0 million in Q3 2025.
    • License revenues for Q3 2026 were $19.0 million, up from $6.7 million in Q3 2025.
    • XIAFLEX pipeline update: The company targets submission of an sBLA to the FDA for plantar fibromatosis in the first quarter of 2027.
    • XIAFLEX pipeline update: Enrollment for the Hammer Toe Phase 3 study was initiated in August 2026.
  • Market and Competitive Landscape:

    • The company is executing a strategy to become a pure-play branded therapeutics company focused on rare or unaddressed conditions.
    • The company benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin.
    • The company's portfolio spans rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.
  • Risks and Challenges:

    • The company faces risks related to the realization of business combination synergies with Endo and the separation of Par Health.
    • Significant indebtedness and transaction costs associated with the Endo merger and Par Health separation remain a factor.
    • The company is subject to risks regarding the Percocet divestiture, including the total consideration received.
    • Regulatory and legal risks include potential governmental investigations, inquiries, and lawsuits related to the company, its officers, and its products.
    • Risks include pricing pressure due to public scrutiny of healthcare costs, reimbursement practices, and changes in laws or regulations.
    • The company relies on a limited number of individual products, specifically Acthar Gel and XIAFLEX, which are material to its financial performance.
    • Risks include potential undesirable side effects of products, product liability losses, and litigation liability.
    • The company faces risks related to supply chain disruptions, reliance on third-party manufacturers, and complex manufacturing processes.
  • Management Commentary and Tone:

    • Siggi Olafsson, Board Chair and CEO, stated that the company has made significant strategic, commercial, operational, and clinical progress toward its goal of becoming a pure-play branded therapeutics company.
    • Management noted that core brands Acthar Gel and XIAFLEX contributed better-than-expected performance in the quarter.
    • Management highlighted that merger synergies are ahead of plan and on track to achieve the three-year target.
    • Management expressed confidence in the clinical progress for XIAFLEX, noting the sBLA submission for plantar fibromatosis is on track for Q1 2027.
  • Other Key Points:

    • The Company completed its business combination with Endo LP on July 31, 2025, and recorded Endo's assets and liabilities at fair value.
    • The Company completed the separation of Par Health, Inc. on November 10, 2025, and presents Par Health's results as discontinued operations retroactively.
    • The company realized $31 million in synergies during the third quarter of 2026.
    • A $151 million pre-tax loss on the divestiture of Percocet impacted the current period results.
    • The company benefited from the absence of $100 million in transaction-related compensation expenses, $76 million lower professional fees related to merger activities, and $52 million lower non-cash amortization of inventory fair value step-up adjustments compared to the prior year.
    • The company updated its definition of Adjusted EBITDA in Q2 2026 to include an adjustment for strategic initiative costs.
    • The company reported a loss on divestiture of $150.6 million for the three months ended September 30, 2026.
    • The company has 39,646,269 ordinary shares issued and outstanding as of September 30, 2026.
Company
MALLINCKRODT PLC
Sector
Healthcare
Industry
Drug Manufacturers - Specialty & Generic