Elite Pharmaceuticals Inc (ELTP)

[RizZo]

FDA and Elite working very close together.




Nasrat Hakim

Thank you, Carter. What a difference a year makes. An increase in revenue from $7.6 million to $18 million is a solid step in the right direction, becoming profitable enough to support an R&D pipeline would get us to the right destination. That is where we want to be. An essential part of growth is to also hold on to what you have. We are working with our partner Lannett to protect our current shares of the market and ensure that we grow it. Lannett is in charge of sales and marketing and they have done a very good job with the market shares for the IR in spite of the fact that it's a saturated market with 11 players. We trust they'll do the same thing with amphetamine ER. From our side, Elite is protecting and improving the business by ensuring that our GMP facility has the right capacity, equipment, material and personnel to support Lannett and our other sales and marketing partners.

We secured enough API quota from the DEA to support Lannett's sales projections through the end of this year. That is fantastic news. We struggled with that in the first quarter and a little bit in the second and finally the DEA came around and gave us enough quota to support the sales and marketing projections through the end of the year. In March, Elite was inspected by the FDA again for Pharmacovigilance and REMS. After eight day inspection the FDA issued a minor observation on a Form 483. The observation was for our website not having a link to REMS for [Indiscernible]. We explained to the FDA that the product is not and has never been marketed or commercialized. Further the link on the website to the REMS was corrected three days before. They issued the observation that did not help. We still got a minor observation but the FDA was kind enough to annotate that it was corrected before they left.

Regardless, this is a great outcome and outstanding news. That makes five inspections, four of which we got zero observations and one that we got this Mickey Mouse observation for. Elite has also successfully pivoted away from opioids during the opioid crisis and the negative environment and lawsuits that came with it and we are extremely lucky that we have never been a part of that. Elite is executing on its growth plan, getting product approvals and launching new products. And our sales and marketing partners Glenmark, TAGI and Lannett are all performing well.


Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2020 Results - Earnings Call Transcript

https://seekingalpha.com/article/4356443-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q4-2020-results-earnings-call-transcript?page=3