ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I agree that their limited disclosure is frustrating. For one reason or another, they are a public company, still operating as if it was still a private company. It would be a good fit within their current infrastructure.

According United Therapeutic's 10-k filing:

We recognized $359.4 million, $325.1 million, and $306.1 million in Orenitram net product sales, representing 15 percent, 17 percent, and 18 percent of our total revenues for the years ended December 31, 2023, 2022, and 2021, respectively,

However, the growth rate YOY for 2024 Q1 was over 20%, hopefully this a trend that keeps going creating a larger market by the time ANIP launches. So it looks like a good revenue generator for 2028 if not sooner.

They also have approval for a generic of AbbVie's Namzaric (21mg ) and tentative approval for the 28mg. Not sure when they can launch, as ANIP acquired it from Amerigen who was in patent infringement litigation with Forrest Labs ( AbbVie) but in the approval letter from the FDA it listed the following.

Agency’s publication titled Approved Drug Products with Therapeutic Equivalence
Evaluations (the “Orange Book”):
U.S. Patent Number Expiration Date
8,039,009 (the '009 patent) September 24, 2029*
8,058,291 (the '291 patent) December 5, 2029
8,168,209 (the '209 patent) May 22, 2026*
8,173,708 (the '708 patent) May 22, 2026*
8,283,379 (the '379 patent) May 22, 2026*
8,293,794 (the '794 patent) November 22, 2025
8,329,752 (the '752 patent) May 22, 2026*
8,338,485 (the '485 patent) November 22, 2025
8,338,486 (the '486 patent) November 22, 2025
8,362,085 (the '085 patent) May 22, 2026*
8,580,858 (the '858 patent) November 22, 2025
8,598,233 (the '233 patent) May 22, 2026*
*with pediatric exclusivity added .

The patent infringement case was dismissed. So it unknown if a settlement was reached and if a date ANIP could launch was part of a deal.