Mallinckrodt postpones split-up plan as opioid lawsuits cloud spinoff's future

Mallinckrodt thought it had a plan to rehabilitate its image, rid itself of low-performing products and banish at least some of its legal problems. But now it's put that plan on hold.

The Irish drugmaker said Tuesday it had postponed plans to spin off its specialty generics business as potential settlements in numerous opioid lawsuits against the company have created uncertainty about the to-be-independent unit's future cash flow.  

Mallinckrodt's spinoff plan, announced in December, would create a new company under the Mallinckrodt name consisting of its specialty generics products, including oxycodone; active pharmaceutical ingredients; and the constipation drug Amitiza.

What's left over—the company's specialty brands, including H.P. Acthar Gel—would operate under a new, as-yet-undetermined name and without the burden of potentially hefty opioid liabilities.

The idea isn't dead, but now isn't the time, the company said Tuesday. “Mallinckrodt continues to actively consider a range of options intended to lead to the ultimate separation of the Specialty Generics business, consistent with its previously stated strategy,” the drugmaker said in a second-quarter earnings release Tuesday.

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Mallinckrodt is one a group of opioid makers that have been targeted in hundreds of lawsuits for their aggressive marketing as the nation’s addiction epidemic raged. In April 2018, the drugmaker was subpoenaed by a U.S. Attorney’s Office in Florida; it already faced civil investigative demands from officials in Missouri, Washington and Kentucky and subpoenas from New Hampshire, Kentucky and Alaska.  

The drugmaker is also a defendant in a massive multidistrict litigation working its way through a court in Cleveland. In mid-April, Mallinckrodt joined Endo and Purdue in attempting to toss out an expert witness opinion stating the companies would have to pay around $480 billion to solve an opioid epidemic they helped fuel.

The judge in that case, Dan Polster, denied the emergency motion and accused the drugmakers of seeking an “indefinite postponement” of the case.

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The spinoff would have disposed of that lawsuit burden along with the generic oxycodone product. But even the company left behind wouldn't be free of legal problems. A group of whistleblower suits accuse the company of paying doctors to prescribe its H.P. Acthar gel, one of the specialty brands that would stay behind.

In early June, Mallinckrodt was hit with a new round of kickback allegations after agreeing to a $15.4 million payout with the feds to settle charges stemming from two whistleblower suits. The newest charges accused the company of funneling money through front funds to illegally subsidize Medicare copays and jack up the drug’s list price 85,000%. 

Mallinckrodt acquired Acthar through a purchase of Questcor Pharma in 2014 and has argued the bulk of Acthar’s price hikes occurred prior to the acquisition.

Acthar is facing even greater hurdles as pricing headwinds have pushed the drug’s sales forecast out of the billion-dollar range on the year. SVB Leerink analyst Ami Fadia called that lower forecast “disappointing” and predicted a stock price drop in response.

On the whole, Acthar raked in $266.4 million in the quarter, a 9.1 decrease. Mallinckrodt specialty brands segment on the whole netted $627.8 million.