ANI Pharmaceuticals (ANIP)

[LordDarley]

The stock is not behaving like it has a great future. I'm a little concerned and I don't have enormous confidence in a square deal from any of the agencies, including FDA.

Consider. Who stands to benefit from Acthar having a monopoly? The kneejerk response is the US government, right? Not the case now.

The bankrupt MNK needs Acthar pricing to stay healthy so that it has cash to pay the various states in the opioid settlement. In some ways, this is like tobacco. The states would never kill the golden goose of tobacco. In theory, this should not matter to the FDA, but who knows what back and forth goes on behind the scene?

The US government now has a fine settlement of the Medicaid dispute. Any future sales thru Medicaid will be at the low price before MNK bought Questor. They don't need ANIP to be competing on price with that deal, and MNK has a bargaining chip if it sells to Medicaid at that price.

Medicare Plan D also does not cover Acthar, so no exposure there.

Posibilities to consider. The states want high Acthar pricing for the cash in the settlement; the US government has a good pricing deal for Medicaid and does not cover it for Medicare Part D.

What's the FDA incentive to add a competitor? If it concludes it is not satisfied with our manufacturing capability to replicate, and requires that we reapply or go through more testing, game over for the stock price.

Hopefully, these are just unfounded fears, but I would have expected a better stock price (and volume) this close to the PDUFA date, and I don't underestimate the potential for some backdoor negotiating.