Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced positive news for two of its drugs this week. Of course bulls are even more positive on the company following the news, while bears still find things not to like about the approvals. Brodalumab, which is used to treat moderate to severe plaque psoriasis, received unanimous support for approval from a Food and Drug Administration advisory committee. The FDA also approved Valeant’s supplemental New Drug Application for the oral form of Relistor, which is used to treat constipation induced by opioid drug use.
Along with the recommendation for approval, the FDA advisory committee recommended warnings for Brodalumab’s label and a regimen to monitor the drug’s safety. The PDUFA action date on the drug is November 16.
Shares of Valeant Pharmaceuticals surged by as much as 3.44% to $24.35 during regular trading hours on Wednesday.
A key step for Valeant’s Brodalumab
Rodman & Renshaw analyst Raghuram Selvaraju sees the vote in favor of approval is a “meaningful positive value driver” for the drug maker because it increases the probability that the drug will be approved this year. Because his current projections don’t include any contributions from Brodalumab, he said in his report that there could be room for upside if approval comes this year.
He believes that Brodalumab will be a competitive drug as it has outperformed Johnson & Johnson’s Stelara. He believes it is unlikely that a black box warning will keep Brodalumab from seeing commercial potential, although he doesn’t see the drug as having “blockbuster capability” in the U.S. He estimates peak U.S. sales at $400 million to $500 million if it is approved, even with a black box warning, because of its strong efficacy, noting that Stelara has already achieved “blockbuster” status.
Arguing for the bears, BMO Capital Markets analyst Gary Nachman said he sees increased commercial risk for Valeant in “launching new products in the current environment.” Further, he doesn’t see them as being “meaningful enough” to change his bearish view. On Brodalumab in particular, he believes the black box warning will result in decreased access to the drug, although he believes the FDA will take a more cautious position and require a REMS rather than a black box warning. He sees adjusted revenue for the drug of only $200 million in 2017 and growing to only $100 million in 2020.
Valeant’s oral Relistor moves forward
Valeant acquired Relistor through its acquisition of Salix Pharmaceuticals 2014, and it has only been available in an injectable form. Selvaraju believes an oral form of the drug could achieve “blockbuster status,” which he defines as more than $1 billion in annual sales. He also believes it might enable Valeant to “compete on a more equal footing against other orally-bioavailable OIC [opioid-induced constipation] drugs,” especially AstraZeneca’s and Nektar Therapeutics’ Movantik, despite its two-year head start.
Nachman also has a much more bearish view on the oral form of Relistor. He argues that although an oral form should help expand the franchise, the market for this type of drug “has become more challenging with pressure from payers, less opioid writing, and AZN’s aggressive promotion of Movantik.” He pegs combined franchise sales of the oral and injectable forms of Relistor at $83 million this year and only $158 million in 2020—far lower than what Selvaraju expects.
Selvaraju has a $90 per share price target and Buy rating on Valeant Pharmaceuticals, while Nachman has a Market Perform rating and $26 price target.
