Dear all,
Though most of the things are covered extensively, I will add one point wrt the REMS program for the drug. Per industry industry sources , this is a very strict REMS program for Lenalidomide. Each tablet has to be counted and dispensed against a valid prescription. This was the reason that generic players could not even obtain RLD for doing bioequivalence itself for the product for many years and there was huge litigation involving this aspect.
The same requirement is still there. Now in the generic environment, it is very difficult to set up this program in a country like US- It may cost upwards of 8-10mn$ to maintain the implement and maintain the same. Therefore all the generic companies, (people with license from innovator) are using innovator REMS program which has been allowed by innovator for some fees. I guess this may be part of the settlement agreement itself.
I heard that TEVA was planning to setup their own system but dont know the progress. This can be one additional factor which will not allow unbridled competition post 2026 also. So this golden goose for Indian pharma may continue even beyond FY 26 given the newer generic companies will have little incentive to setup a costly system (not to mention the wherewithal to handle this).
With many of other things falling in place, this can be significant year for Natco - reasonable domestic growth, Agro opportunity maturing, launch of Lonsurf plus the lenalidomide bonanza continuing. Infact this qtr may be absolute blockbuster with profit in excess of 500 Cr for them.
Thanks.
Nikhli
DISC: Invested in last one month. Also the above estimates are mine. Brokerage estimates are @400 Cr+. So obviously they can be significantly wrong. Take it with Load of salt.
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