ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Yodle, Libigel or whatever it will be called is not all that ANIP has to offer. They have a fast growing portfolio of generic and Specialty Brands with a large pipeline of previously approved drugs. Which will create a steady but fast growth. In addition they have the Cortico franchise which according to the CEO they figured would bring in approx. $200 million in revenue. That has probably grown now to $260 million.

They have a stake an ownership stake in Cold Genesys, a private company conducting phase 3 trials in Bladder Cancer.Their original stake was 19.9%, not certain what is is now, but they also will receive future royalties, if approved. The ANIP CEO sits on their BOD.

Cold Genesys


As for Libigel, they already have patents in relation to testosterone restoration for women and treating HSDD that go to between 2028 and 2032. They are now working on the patents for CV and cancer risk reduction.

With the recent court decisions that condones off label use when supported with clinical data, is acceptable, even if the FDA has not approved the drug for that purpose. They also have that avenue.

They appear to have enough to get Libigel to market with no competition for 5 years, in relation to CV risk reduction and Breast Cancer reduction. HSDD treatment at least with testosterone, they have a longer runway.

Libigel is a $2 to $3 billion dollar drug just by replacing off label and compounded testosterone and could grow to $6 billion. In 2011 they were looking at 4.1 million prescriptions they expected to grow to 9 Million when an FDA approved drug is available. A survey showed that 96% of physician would immediately switch over their patients to Libigel.

(Caveat they failed to beat placebo in treating HSDD in phase 3 efficacy trials, but it appears the Satefy study was a safety net for an new way do testing in the failed trails).

You are correct the even bigger market is CV and Breast Cancer. Note the sales estimates were for US Only.

Since Libigel and Cold Genesys are not factored into the current price, unlike a small biotech, where price can be hit hard by drug failure, ANIP is a stable investment with huge upside potential and little downside.

JMHO.