Elite Pharmaceuticals Inc (ELTP)

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Everyone Is Talking About Elite Pharmaceuticals Inc (OTCBB:ELTP)

Elite Pharmaceuticals Inc (OTCBB:ELTP) has been moving up steadily in recent weeks attracting legions of shareholders who continue to bid it higher. There is plenty to get excited about on ELTP as the Company continues to grow and now boasts several FDA approved products and significant revenues.

The Company filed a PRE 14A on April 17 reporting a special meeting of shareholders will be held at the Residence Inn by Marriott located at 206 Route 303, Orangeburg, New York 10962 on June 23, 2020, at 10:30 a.m., local time for the following purposes: 1; To again vote on the prior amendment of our Articles of Incorporation to increase the number of shares of common stock the Company is authorized to issue from 995,000,000 shares to 1,445,000,000 shares and to file a new amendment to our Articles of Incorporation reflecting such approval; 2; To approve a proposal to grant discretionary authority to adjourn the Special Meeting, if necessary, to solicit additional proxies in the event that there are not sufficient votes at the time of the Special Meeting to approve Proposal 1; 3; To transact such other business as may properly come before the Special Meeting or any adjournments or postponement thereof.

Elite Pharmaceuticals Inc (OTCBB:ELTP) is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic products which have been licensed to TAGI Pharma, Glenmark Pharmaceuticals, Inc., USA., and Lannett Company, Inc. Elite currently has eleven approved generic products, three generic products filed with the FDA, one approved generic products pending manufacturing site transfer, and an NDA filed for SequestOx™. Elite’s pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

Elite’s principle product is SequestOx™, an immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain. Additional products include bariatric, cardiovascular, antihistamine, skeletal muscle relaxants, antipsychotic, tricyclic antidepressant, along with a number of approved products pending manufacturing site transfer.

Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse.

Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite owns generic which have been licensed to TAGI Pharma, Epic Pharma, Dr. Reddy’s Laboratories and Glenmark Pharmaceuticals Inc., USA. Elite currently has eight commercial products currently being sold, six products filed with the FDA, additional approved products pending manufacturing site transfer and the NDA filing for SequestOx™.

ELTP revenues are impressive – On February 10 ELTP reported results for the third quarter of fiscal year 2020 ended December 31, 2019. Consolidated revenues for the Third Quarter were $5.1 million, an increase of approximately 88% as compared to revenues for the comparable quarter of the prior fiscal year. The increase in revenues was largely attributed to revenues from the two products launched during the 2020 Fiscal Year, generic immediate release Adderall® and Dantrolene Capsules as well as strong growth in revenues relating to the sales of Isradipine capsules.

Microcapdaily has been covering Elite Pharma for years, we noted on November 14, 2014 – Elite Pharmaceuticals Inc (OTCBB:ELTP) made a highly explosive move up earlier this year off its base at a dime the stock saw highs over $0.90 per share on significant volume. Currently hovering over recently established $0.30 support ELTP continues to be one of the top traded stocks on the entire OTCBB: ELTP has been around for many years and used to trade on the Amex stock exchange where it once saw highs of $22 per share. The Company was delisted to the OTCBB in 2009 where it sat dormant for several years before the recent explosion in price and volume.

In December ELTP announced it received approval from the US Food and Drug Administration (FDA) for a generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (formerly QuintilesIMS Health) data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019. Generic Adderall XR is jointly owned and the second product approval for our Elite and SunGen Pharma LLC collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor.

On March 31 ELTP announced its marketing partner Lannett Company, Inc. has commenced product launch of Elite’s generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules. Adderall XR®, including generic versions, have an estimated IQVIA™ market value of approximately $1.3 billion for the twelve months ending January 2020. Adderall XR® is a once-daily central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

This generic Adderall XR® product is jointly owned by Elite and SunGen Pharma LLC and is the second product launched from their collaboration. Elite will manufacture and package the generic product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor for the product and will provide sales, marketing, and distribution.

Currently trading at a $74 million market valuation ELTP does have $1.8 million in the treasury, $24 million in assets and $7.7 million in current liabilities. ELTP is an exciting story in small caps with a number of FDA approved drugs already on the market reporting significant sales – ELTP reported $13,049,340 in revenues for the 9 months ended December 31, 2019 up from $6.2 million for the same period in 2018

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