Indivior scraps annual guidance on drop in Suboxone Film market share, Sublocade challenges

Indivior said Wednesday that its financial targets for 2018 are "no longer valid" in the wake of FDA approval of Dr. Reddy's Laboratories' generic version of Suboxone Film (buprenorphine/naloxone) and early uptake levels of Sublocade (buprenorphine). Shares in Indivior fell as much as 37 percent on the news.

Last month, the FDA cleared generic versions of Suboxone Film from Dr. Reddy's and Mylan, with the Indian company opting for an "at risk" launch. Shortly afterwards, a US district court granted Indivior a temporary restraining order forcing Dr. Reddy's to immediately cease launch activities for its product, with the order later extended.

However, Indivior CEO Shaun Thaxter said that "there is a range of uncertainty around the amount of product" that Dr. Reddy's was able to ship before the temporary restraining order was issued. Indivior indicated that it has seen "recent accelerated market share loss" for Suboxone of 2.5 percentage points, to 52 percent, in the most recent weekly data. The US drugmaker suggested that this level of market share loss will impact revenue by $25 million this year.

According to Indivior, sales this year will also be hit by around $50 million due to the "level of discounting" on generic versions of Suboxone tablets, which has resulted in pricing of 75 percent to 80 percent below list price. The company explained that this "has further reduced the profitability of the most price sensitive channel," which is Managed Medicaid, with the drugmaker experiencing lower than expected net revenue as a result.

Thaxter added that the company is also experiencing "some friction" regarding its new reimbursement and distribution model for Sublocade, and expects annual sales in the range of $25 million to $50 million, approximately $50 million lower than its internal forecasts. The US drugmaker previously estimated that overall sales this year would be in the range of $1.13 billion to $1.17 billion, with net income between $280 million and $320 million.

"We are looking at cost saving opportunities, initially targeting at least $25 million in cost savings in 2018, to partially offset the financial impact of these developments," Thaxter explained, adding "we will provide more details on the Sublocade launch, cost saving initiatives and overall business performance with our 2018 half-year results presentation on July 25."

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