ANI Pharmaceuticals (ANIP)

[Just the facts maam]

BB, I feel optimistic about ANIP continuing to beat estimates and raise guidance for the foreseeable future for the following reasons.
- Novitium should keep rolling out generic drugs to outpace erosion from competition.
- The market's under estimate Corti's peak sales
- Zero value has been given to female testosterone, with results pending.
- Zero value has been given ANIP's potential royalty and milestone payments for CG Oncology's Cretostimogene.
- Regarding Cretostimogene and female tetosterone, in 2023, 89% of NDA's were approved cancer. So for future filings.
- Though we don't know the details of the Cold Genesys Biosante deal, at the time Biosante was represented by Oppenheimer Wolff & Donnelly LLP the same law firm that hammered out the GVAX agreement with Aduro Biotech. So at a minimum, I expect a clause in the deal covering royalties during the FDA approval exclusivity period (even after patent expiration), just like they did in the GVAX deal. It the deal gave them 5% on Global sales.
- JP Morgan pegged peak sales at $2.3 billion.
- I read an article where effective cancer drugs reach peak sales within 5 years. Assuming it gets approved , JP Morgan is correct regarding peak sales and ANIP is successful in litigation ANIP could receive $530 million in royalties plus milestone payments between 2026 and 2032. This is most likely in addition to any royalties for other indications if approved.

Lots to be bullish about.

GLTA


[tag]https://www.statista.com/statistics/817552/key-measurements-of-us-cder-drug-approvals/[/url][tag]FDA Approval Rate[/tag]