PHARMACY

Mallinckrodt to spin specialty generics business off to shareholders

BY David Salazar

Specialty pharmaceutical company Mallinckrodt will be creating a new company focused on specialty generics and active pharmaceutical ingredients by spinning that business and its Amitiza (lubiprostone) off to its shareholders. The move, which is subject to board approval, would create two independent, publicly traded companies — one of which offers branded specialty products, the other offering niche specialty generics and API manufacturing.

“Today’s announcement is another important step forward in our journey to become an innovation-driven, pure-play, specialty pharmaceutical brands growth company,” said Mallinckrodt president and CEO Mark Trudeau — who will lead the “remaining” specialty brands business after the separation.

Mallinckrodt’s specialty generics business saw net sales of more than $850 million for the 12 months ended Sept. 28, which includes sales of Amitiza since Feb. 14. The new company would have roughly 1,600 employees and a leading acetaminophen business, with a portfolio that includes API and generic finished dose forms of controlled substances and other products, a specialty generics development pipeline, and a solid U.S. manufacturing footprint, Mallinckrodt said.

Mallinckrodt said it expects the move to be complete in the second half of 2019 or sooner. The spun-off company is expected to be listed on the New York Stock Exchange and assume the Mallinckrodt name and ticker symbol, MNK. Matthew Harbaugh, who currently serves as Mallinckrodt’s executive vice president, CFO and president of the specialty generics business, is expected to become president and CEO of the new company. Harbaugh will be stepping down as CFO to focus on the separation, the company said.

“Mallinckrodt has a more than 150-year legacy of operations in St. Louis and a proud history of supplying the highest-quality products to customers,” Harbaugh said. As an independent, U.S.-based company, I am confident that we will be well positioned to advance our R&D capabilities and continue to maintain our category leadership in controlled substances.”

The specialty brands company will be led by Trudeau under a new name that will be chosen at a later date. George Kegler has been named interim CFO. The remaining business will encompass a branded specialty pharmaceutical arm that saw more than $2.3 billion in net sales for the 12 months ended Sept. 28. It includes such hospital products as INOmax, Ofirmev and Therakos.

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