Endo International plc – Ordinary Shares (ENDP): Opana ER Gets Thumbs Down from FDA Panel, Canaccord Sees Just a Modest Impact


This afternoon, a joint session of the FDA Drug Safety and Risk Management and the Anesthetic and Analgesic Drug Products Advisory Committees voted 18-8 that the risks of abuse from Endo International plc (NASDAQ:ENDP) long-acting opioid painkiller, Opana ER, don’t outweigh the benefit from having the reformulated branded oxymorphone opioid on the market.

However, Canaccord analyst Dewey Steadman believes that the negative panel is expected to have only a modest impact on the stock. The analyst maintained a Hold rating on ENDP, with a price target of $14, which represents a potential upside of 37% from where the stock is currently trading.

Steadman commented, “Endo received a modest setback from a negative FDA advisory committee meeting surrounding Opana ER that could lead to the product being pulled from the market. While Opana ER previously was a large contributor to Endo’s top and bottom lines, since generics launched against the original formulation annual revenue has declined to around $150 mm annually out of a $3.4 bn consolidated top line for the company.”

“Net/net, while no final decision has been made to pull Opana ER from the market (yet), we see little impact to Endo should Opana ER ultimately be pulled. We remain at HOLD on ENDP shares given longer-term growth challenges coupled with a near-term lack of financial flexibility,” the analyst concluded.

According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Dewey Steadman has a yearly average return of -4.0% and a 43% success rate. Steadman is ranked #3593 out of 4517 analysts.

Out of the 9 analysts polled in the past 3 months, eight rate Endo stock a Hold, while only one rates the stock a Buy. With a return potential of 58%, the stock’s consensus target price stands at $16.14.

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