I concur that the discussion covered a range of issues that real investors should be happy to hear.
Quickly, a short recap and then off to educate...so, in no specific order...
First, one matter that was explained and served to quell concerns on my part was the IR & XR LCI got approved and the concerns for competition. It was made clear that Nasrat has similar concerns and, based on his answer that included a soft bash of LCI, he is looking for a new partner or adding headcount for his own sales & marketing. As to the latter, Nasrat knows it is better with a partner than adding G&A costs. I expect they would pursue a new partner and, given the prospects of an approved product sometime by end of June 2022, he can terminate the LCI contract and engage the other firm. This may arise in the last half of 2022.
The explanation of the lack of PR on the Dexcel agreement was very good and my question was answered and more was said. For example, the logic behind not issuing a PR made sense, as it helped Dexcel and that is important early in a partnership; each side has the chance to show their commitment and Elite did. It was also explained why no XR at this time and that, most importantly, the EU is in play. For me, Nasrat showed he gets the market penetration strategy that will position Elite best for the future with ex-USA commercialization.
Clarity was given on the impact of the pandemic on Elite and it was well done. No major issues with API, but he was upfront about how it has impacted Elite's product testing. I knew this to be true for all pharma. Companies that run the test have been impacted from a labor perspective, so this is not limited to Elite.
Speaking of the FDA, it is clear they have had a significant and negative impact on Elite. And yet, Elite continues to move forward. Relatedly, the discussion of new products under development and the expectation that the one they have filed will be approved before the next CC. In fact, unlike most times, Nasrat did not say he would be talking to investors at the next CC, which would be EOY and has been a point he has made before. No, he said he will be "talking" to us soon. Interesting!
The PFE discussion made clear what was and is going on. Not a partnership, Elite needs PFE to make a batch of ADT Oxy so Elite can do trials needed for submission of the ANDA, which sounded more like an NDA and that means a premium price, something that would enable Elite to rise above the generic competition. A BFD when considering market share capture. This is very good news, but it is a process that would explain the calls. I expect one of the pieces to negotiate will be what Elite will pay PFE for their efforts. Much depends on whether PFE has what it needs or if Elite will provide it and, here is the big thing, whether PFE would allow Elite to do the manufacturing of the ADF Oxy comparator, under consult and review..
Okay, let me end by saying that with $24.6 million in revenues through Q3, Elite nearly hit the revenues for all of 2021. In looking at the progress, I thought 2022 would be about $32M but now I think it will be closer to $35M.
In sum, the company is positioned and positioning itself well for the future and that is the business reality.
