Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

In Q3 2021 CC, here is what Nasrat said…

Lannett is also our marketing partner for Amphetamine IR and they have been successful at capturing substantial market share. This product with Amphetamine ER is an important driver in our growth.

It is worth noting that LCI just reported revenues for CNS drugs that increased in Q3 2021 to 20% of its total revenues, up from 12.8% in 2020. An increase that should correspondingly be reflected in Elite's Q4/EOY revenue total.

In the Q3 2021 CC, Nasrat also said this...

We are working on the central nervous system project that we have discussed previously. This project belongs to Elite with all its benefits and costs. They know how optimizing formulation, cost of the raw materials to manufacture the exhibit batches, conducting clinical trials and filing the product are Elite’s responsibility. We have resolved the issues with SunGen and this product is now 100% ours.

In that statement Nasrat did not say what the market size was expected to be, but in Q3 2020 (exactly one year prior) he did mention it...

It's a $1.5 billion product, and it has 8 manufacturers in it that are approved now. And the $1.5 billion is according to the old IMS, which is IQVIA number by September 2019.”

This much discussed potential CNS ANDA that he speaks of having a $1.5 B market (generic Concerta or something else) is based on September 2019 IQVIA numbers. With a CAGR at 8.5%, we can reasonably expect IQVIA to project this drug - whatever it might be - to be about $1.75 B market today. The point at which this drug achieves peak revenues (about 3-5 years post approval), this unnamed CNS ANDA alone has the potential for a prorated split (proportionate market share) of greater than $200 M for Elite.