Takeda’s $200 million loss as Novartis withdraws marketing application

Takeda announced the anticipated financial loss from Novartis’ withdrawal of the marketing application for Xiidra.

Xiidra (lifitegrast ophthalmic solution 5%) is the first and only prescription treatment approved by the U.S. Food and Drug Administration for both signs and symptoms of moderate- severe dry eye disease, with a mechanism of action that targets inflammation. It was one of the products obtained through the acquisition of Shire by Takeda in January 2019.

In July 2019, Takeda completed the sale of Xiidra to Novartis for a sales price of $3.4 billion upfront in cash and up to an additional $1.9 billion in potential milestone receipts, including certain sales-based milestones.

As a result of Novartis’ withdrawal of the marketing application for Xiidra in Europe, Takeda expects that the probability of receiving certain sales-based milestones may be reduced, although the total potential milestone receipts of up to $1.9 billion remain unchanged. As a result of the remeasurement, Takeda anticipates that it will recognise a loss of approximately $200 million for the three-month period ending June 30, 2020.

Takeda will continue its $10 billion of divestitures of its non-core business to pay off its merger debts. 

Xiidra was registered in Australia by Shire and sponsorship transferred to Novartis in September 2019.