With respect to Rexista, I am really hoping for a delay on the PDUFA date… to me that would indicate the FDA is much more likely to wait for the studies to complete and consider approval. This would prevent IPCI from having to pay the application fee and endure the long wait of the application process… again. Hopefully the FDA will see what kind of a burden that would be and how that would prevent an incrementally better product than what is available to get to the market (granted the studies are positive), without considering the fact that IPCI followed the FDA’s guidance the whole way. But like I said, that is just what I am hoping for, otherwise to go through the whole process again… ugh... yeah, a couple years.
I am staying long IPCI however, and personally am really looking forward to approval and commercialization of just 1 more ANDA, as should new investors… valuation is all subjective until there are real earnings. Breakeven is a great milestone which they will have accomplished with just Focalin and Seroquel, but as you can see it doesn’t do much for creating a floor in share price like a P/E valuation will.
With that being said, the next ANDA will be big in my opinion, and at these levels new investors should understand where IPCI is outside of Rexista and how that can hedge the risk of Rexista. If their next generic only means $ 5M to the bottom line, similar to Focalin (one that they don’t manufacture on a cost plus basis), that would be $ 5M in earnings as they are at least breakeven with Focalin and Seroquel, and a 15 PE puts IPCI at a $ 75M market cap, or $ 2.25 – $ 2.50 per share without putting any value toward the remainder of their pipeline. That’s a nice return for those who can pick up shares at a measly $ 1.20, and that only considers 1 ANDA, without a manufacturing agreement at that.
While any number of ANDA’s could be approved any day, don’t write off even their latest application for Ranexa…
If I understand everything correctly, per GDUFA, IPCI’s Ranexa application (submitted in December 2016) falls into the 5th cohort (5th year of GDUFA’s applicability) and the performance target for the 5th cohort is that 90% of all ANDA’s are reviewed and acted upon within 10 months of submission, which is right around the corner! I’m not sure I have seen any chatter on this yet, if someone already brought it up I'm sorry if I stole your thunder.
AI
