Teva Pharmaceutical Industries Ltd. (TEVJF), (NYSE and TASE: TEVA) today announced the launch of generic version of Syprine®1 (trientine hydrochloride) capsules, 250 mg, in the U.S.
Trientine hydrochloride is used in the treatment of patients with Wilson’s disease who are intolerant of penicillamine.
Wilson’s disease is a genetic disease that prevents the body from removing extra copper. The body needs a small amount of copper from food to stay healthy, but over time, high copper levels can cause life-threatening organ damage. Wilson’s disease is a rare disorder that affects approximately 1 in 30,000 individuals.2
Teva has the largest portfolio of FDA-approved generic drugs; it needs to continue to launch new drugs to replace the loss of exclusivity (“LOE”) for Copaxone, its blockbuster multiple sclerosis treatment. Meanwhile, Valeant has been cutting costs and divesting assets to prove to investors it can service its $27 billion debt load from new and existing products.
In 2015 Valeant was one of several companies Hillary Clinton pointed out for price-gouging. In December 2017 the Senate Special Committee on Aging issued a 130 page report that gave recommendations on how to combat price gouging. It specifically mentioned Valeant and its pricing for Syprine. Syprine and Cuprimine are both used to treat Wilson’s disease. Valeant acquired both drugs in 2010 as part of its $318 million acquisition of Aton.
After the company became the sole source for the treatment of Wilson’s disease Valeant implemented major price increases for both drugs:
Management then developed the Organ Drug Pricing Plan, which included price increases for Syprine and Cuprimine of 400% and 100%, respectively. According to a chart provided by the Committee, from 2010 to July 2015 Valeant increased the price of Syprine by over 3,100% and the price of Cuprimine by over 5,700%.
Since the Senate Special Committee report the FDA has been made a concerted effort to streamline the approval process for general drugs. That said, the launch of generic Syprine could have a meaningful impact on Valeant’s EBITDA.
The company’s Q3 2017 revenue was off 10% Y/Y. The decline was driven by Branded Rx (ex-Salix) and U.S. Diversified which were off 45% and 29%, respectively. They represent 29% of Valeant’s total revenue and several of their products face LOE.
Q3 revenue from Syprine was $18 million, and the drug is included in the U.S. Diversified segment. Since Cuprimine ($20 million in revenue) also treats Wilson disease I believe it could also be at risk from generic Syprine. Cuprimine and Syprine generated $38 million in combined Q3 revenue – this represents 11% of U.S. Diversified revenue and 1.7% of Valeant’s total revenue. The rub is that U.S. Diversified’s EBITDA margins are 75% versus 42% for the entire company. If 58% of Cuprimine and Syprine’s combined revenue goes away (assumes 30% price reduction and 40% loss of market share), it could cut Valeant’s EBITDA by nearly 2%. This estimate could also be optimistic given the out-sized price increases already implemented for Cuprimine and Syprine.