Mallinckrodt Reports $1.98 Billion in Net Sales for Fiscal Year 2024, Driven by Specialty Generics Growth

Mallinckrodt plc reported net sales of $1.98 billion for the fiscal year ended December 27, 2024 (Successor), a 6.1% increase compared to the non-GAAP combined fiscal year 2023 figure of $1.86 billion. This increase was primarily driven by a 15.4% rise in Specialty Generics segment sales, largely due to increased finished-dosage generics sales and controlled substance API demand. However, the Specialty Brands segment experienced a 0.5% decrease in net sales, mainly attributed to declines in INOmax, Therakos (following its November 2024 divestiture), and Amitiza sales, partially offset by increases in Acthar Gel and Terlivaz. The company's gross profit margin for fiscal 2024 was 41.8%.

Significant changes compared to the prior fiscal period include the divestiture of the Therakos business for $887.6 million (net of adjustments), resulting in a $754.4 million gain on sale. Proceeds from this sale were used to prepay certain term loans and redeem notes, resulting in a net loss on debt extinguishment of $19.7 million. The company also entered into a transaction incentive plan, paying $13.6 million in bonuses during fiscal 2024, with an additional $16.4 million expected upon completion of certain transactions. Furthermore, Mallinckrodt launched a new delivery device, SelfJect, for Acthar Gel in August 2024.

Strategic developments during the year included the announced proposed business combination with Endo, Inc., subject to various conditions. This transaction would result in Mallinckrodt shareholders owning 50.1% of the combined entity's outstanding shares. The company also completed the previously announced sale of its Therakos business. The company's workforce totaled approximately 2,700 employees as of December 27, 2024, with 60% located in manufacturing and distribution sites.

Key operational developments included the successful launch of the Acthar Gel SelfJect injector, which received FDA approval in March 2024. The company also noted continued competition for INOmax in the U.S. market. In the Specialty Generics segment, sales increased despite a decline in acetaminophen sales due to market softness. The company's largest customers in fiscal 2024 were FFF Enterprises, Inc. (23.1% of net sales), and Cencora, Inc. (formerly AmerisourceBergen Corp.) (13.8% of net sales).

Mallinckrodt's outlook includes the pending business combination with Endo, which is subject to shareholder and regulatory approvals. The company anticipates increased indebtedness as a result of this combination, including the assumption of Endo's existing debt and the incurrence of new debt. The company also highlighted various risks, including those related to competition, regulatory changes, indebtedness, and litigation. The company's financial statements are not comparable to prior periods due to the application of fresh-start accounting following its emergence from bankruptcy proceedings in 2022 and 2023.