Elite Pharmaceuticals is a specialty pharmaceutical company specializing in niche generics and committed to the development of abuse-deterrent opioids to help curb diversion, misuse and abuse. Elite has a pipeline of opioid abuse-deterrent products under development utilizing the company’s proprietary pharmacological abuse-deterrent technology.
Elite’s website can be found by going to http://www.elitepharma.com
How ART Works:
Elite’s proprietary abuse-deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.
Recent Press Releases:
Oct 21, 2015 Elite Pharmaceuticals Announces Positive Top-Line Results From a Pivotal Phase 3 Study for Abuse-Deterrent Opioid ELI-200 http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=79416&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0
Aug 10, 2015 Elite Pharmaceuticals Reports Record Revenues for First Quarter of Fiscal Year 2016 http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=78453&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939
Aug 3, 2015 Elite Pharmaceuticals Completes Enrollment and Dosing for ELI-200 Phase III Efficacy Trial http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=78262&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939
Jun 16, 2015 Elite Pharmaceuticals Granted New Patent for Abuse Deterrent Technology http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77581&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939
Jun 9, 2015 Elite Pharmaceuticals and Epic Pharma Enter Into a Sales and Distribution Licensing Agreement for Abuse-Deterrent ELI-200
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77479&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0 More information can be found by going to Elite’s investor section: http://ir.elitepharma.com/press_releases
Highlights From Last Quarter:
Second quarter ending September, 2015
Consolidated revenues for the second quarter of fiscal 2015 was $2.7M, all of which came from Elite's generic operation. An increases of 30% over last quarter's generic revenues. Generic revenue continues to grow with new highs being set 8 out of the 10 last quarters. The cost of revenue for this quarter totals $1.4M, for a gross profit of $1.3M. Overall expenses for the quarter total $5.3M with $4.2M going towards the development of Elite’s proprietary abuse-deterrent opioid product,ELI-200.
The first product to utilize Elite's abuse deterrent technology, ELI-200, has successfully completed Phase III studies. The Company believes that it will be able to file a New Drug Application (NDA) with the FDA during this calendar year. When this application is accepted by the FDA it will be granted expedited review by the FDA,the company estimates that approval could be achieved in calender Q2\2016. Shareholders will be notified when the FDA accepts the ELI-200 NDA which is estimated to be in the first or second week in Jan, 2016.
Common shares issued pursuant to the strategic alliance agreement with Epic Investments LLC.
As per the Epic Strategic Alliance, Elite is entitled to 15% of the profits achieved from the commercial sales of Epic's immediate release oxycodone tablets, for a 10 year period commencing on the date of first commercial shipment and Epic is to receive 3 million shares of Common Stock upon approval by the FDA of the ANDA.
President & Chief Executive Officer - Nasrat Hakim
Nasrat Hakim joined Elite in August 2013 as Director, President and Chief Executive Officer. Mr. Hakim has more than 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. Prior to his leading Elite, from 2004 to 2013, Mr. Hakim was employed by Actavis, Watson and Alpharma in various senior management positions. Most recently, Mr. Hakim served as International Vice President of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees under his leadership. Mr. Hakim also served as Corporate Vice President of Technical Services, Quality and Regulatory Compliance for Actavis U.S., Global Vice President, Quality and Regulatory Compliance for Alpharma, as well as Executive Director of Quality Unit at TheraTech, overseeing manufacturing and research and development. In 2009, Mr. Hakim founded Mikah Pharma, LLC, a virtual, fully functional pharmaceutical company.
Mr. Hakim’s career started in Medical Laboratory Technology from the Academy of Health and Sciences in the U.S. Army based in San Antonio, TX, followed by Graduate Certification in Regulatory Affairs (RAC) from California State University at Sacramento, Sacramento, CA; Bachelor in Chemistry/Bio-Chemistry and Masters of Science in Chemistry from California State University at Sacramento, Sacramento, CA; and a Masters in Law with Graduate Certification in U.S. Taxation from St. Thomas University, School of Law, Miami, FL.
Board of Directors Chairman - Jerry Treppel
Mr. Treppel is currently a Managing Director of ArcLight Advisors, an investment bank specializing in the health care sector. From October 2008 through March 2013, Mr. Treppel was Managing Director of Ledgemont Capital Group LLC, a boutique merchant bank that provided access to capital and corporate advisory services to public and private companies. Additionally, he served as the managing member of Wheaten Capital Management LLC, a capital management company focusing on investments in the health care sector from 2003 to 2008. Over the past 20 years, Mr. Treppel was an equity research analyst focusing on the specialty pharmaceuticals and generic drug sectors at several investment banking firms including Banc of America Securities, Warburg Dillon Read LLC (now UBS), and Kidder Peabody and Co. He previously served as a healthcare services analyst at various firms, including Merrill Lynch & Co. Mr. Treppel holds a BA in Biology from Rutgers College, an MHA in Health Administration from Washington University, and an MBA in Finance from New York University. Mr. Treppel has been a Chartered Financial Analyst *CFA) since 1988.
Vice President of Investor Relations and Corporate - Dianne Will
Dianne Will joined Elite in 2003 as an Investor Relations Specialist and was named Elite’s Vice President of Investor Relations and Corporate Affairs in 2013. In 1996, Ms. Will founded Willstar Consultants, an investor relations consulting firm and has been providing investor relations services to a range of public companies for more than 19 years with a primary focus in the pharmaceutical and tech sectors. Her firm provides corporate services including management and execution of investor relations programs, investor communication, peer research, compliance services, support for
management team changes, proxy fights, crisis management and IPOs.
Investor Relations and Corporate Inquiries
Vice President of Investor Relations and Corporate Affairs
165 Ludlow Avenue
Northvale, New Jersey 07647
SEC Filings: http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001053369&owner=include
FDA website: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Clinical Trials.Gov: https://www.clinicaltrials.gov/
Using the industry average PE\Ratio of 15, an over exaggerated share count of 100% of the 995M authorized shares, and a very conservative
profit margin of 30%, Elite stands to garner an increase in share price with the launch of each abuse resistant opioid product.