Elite Pharmaceuticals Inc (ELTP)

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Analysis of Elite Pharmaceuticals ART Market Share Opportunity

Using the industry average PE\Ratio of 15, an overinflated share count of 995M, and a conservative profit margin of 30%, Elite stands to garner an increase in share price with the launch of each ART opioid product.


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Elite's current ANDAs make Elite cash flow positive, and with revenues growing each quarter, conservative estimates place revenue in the $8-10M range for FY 2015. Also, the 12 ANDAs licensing deal with Epic makes Elite very profitable, as all revenues go to the bottom line with zero operational costs (See link below for more information). All other revenues from Elite's ELI-ART is all extremely profitable which makes the above spreadsheet unquestionably realistic. In fact, currently there are zero FDA approved ADT\ART products on the market, and there would then be no limit as to what percent of the $9.38B market that ELI-ART could capture with just one product.

"We have two opioid abuse deterrent products, ELI-200 and ELI-201, in human trials and an additional five abuse deterrent formulations under active development. We are very pleased with the success of the product trials in recent months. The ELI-201 pilot study showed that more than one of Elite’s formulations was bioequivalent to the brand product, and the ELI-200 pivotal study demonstrated bioequivalence of Elite’s product to the reference product. We expect to file our first abuse deterrent New Drug Application (NDA) with the FDA this year and we then expect to file additional NDAs the following year. We have also received further protection for these abuse deterrent products with the issuance of two patents, an additional patent allowed in the U.S. and the issuance of one Canadian patent in recent months. We have additional patents filed and pending in the U.S., Canada and Europe. Elite’s technology can be applied to any of the current opioids in the market place, and our goal is to broadly use our technology to reduce the current epidemic of prescription drug abuse". - Nasrat Hakim, CEO and President. Letter to The Shareholders April/2014

Recent ELI-ART Press Releases

4/14/2014 - Elite Secures $40 Million Funding Commitment From Lincoln Park Capital Fund, LLC
http://archive.fast-edgar.com/20140414/ANAZQ22CZM22T2Z2222P2MZIQB4UZB22N662

3/27/2014 - Elite Pharmaceuticals Appoints Barbara Ellison as Vice President of Quality Operations and Regulatory Affairs
http://www.elitepharma.com/investor_relations.asp?goto=381

3/10/2014 - Elite Pharmaceuticals Expands Abuse Deterrent Technology Patent Portfolio Internationally
http://www.elitepharma.com/investor_relations.asp?goto=379

3/5/2014 - Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study for Abuse Deterrent Product ELI-200
http://www.elitepharma.com/investor_relations.asp?goto=378

2/18/2014 - Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201
http://www.elitepharma.com/investor_relations.asp?goto=377


Additional References

OxyContin sales make up about $2.81 billion, or 30% of the $9.38 billion U.S. market for prescription painkillers in 2012, according to IMS Health Inc., a health-care data provider based in Danbury, Connecticut.
http://www.bloomberg.com/news/2014-01-14/purdue-pharma-loses-oxycontin-patent-trial-against-teva.html?cmpid=yhoo

Manufacturing and License Agreement for Twelve Generic Products
http://www.elitepharma.com/investor_relations.asp?goto=367