--Right Place at the Right Time with the Right Products CEO
--Billion dollar pipeline made up of a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg
--4th quarter 2013 1.5 million in revenues best in co. history
--cash flow positive (CFP) this quarter, not including R&D cost, the Board of Directors making break even operations essential
--Manufacturing revenue for the 4th quarter(2013 fisical) totals $969 for an increase of $569K, or 142% from the previous quarter.
Royalty & Lic. revenue for the 4th quarter(2013) totals $368 for an increase of $212K, or 135% from the previous quarter.
Lab fee revenue for the 4th quarter totals $187 for an increase of $76K, or 68% from the previous quarter.
--launched drugs continue to gain market share
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development only, temporary working capital, pilot studies and trials used $320k so far
--600 % increase in market cap in 2 years
--out standing shares 374K
--ELI-154 24 hr ER oxy (w/o ART) still in scale up will be sold on the European market looking for a partner
--12 hr oxycodone with ART starting pilot studies calendar 2013 for a 3 Billion dollar market will pave the way for the once a day which will only have to demonstrate (prove) bioequivalence to the twice a day formula
--ELI-216 is a controlled release 24 hr NDA abuse resistant(ART) oxycodone requiring Phase III clinical trials
--a partner for commercialization of ELI-216 will be done once human data gathered(multiple short studies required) then discuss with FDA JT wants to license after studies and trials complete making it worth much more due to the steep accretion curve in the pharma field
--ELI-216 is a priority with Elite and further along than most people think, per CEO
--FDA likes the pharmalogical approach to abuse resistance per CEO
--1st patent for ELI-216 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for ELI-216 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection on their 2 bead ART: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection
--2-bead abuse resistant opiods could replace the inferior abuse deterrent(easily defeated) opiods now on the market
--Elites ART is modular (plug and play system), not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies late calendar 2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims
***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA
1) Pfizer PFE
2) Endo Health ENDO
3) Pain Therapeutics PTIE
4) Acura Pharma ACUR
5) Durect Corp DRRX
--Elite owns approx 10% of Novel Labs, Gavis and recently Wintac: Novel and Elite have an ongoing dialog for monetization a lot goes into determining the value of a private co.
--Novel Labs adds to Elites value estimates for Novel's value range from 10 to 50 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--Novel has provided to the Company, copies of its prior year tax returns and management prepared forecasts showing growing revenues
--CEO and officers being paid with stock
--CEO Jerry Trepple loaned the co. 1 million dollars unsecured (non-dilutive) 600k used considering taking stock as repayment of loan
--CSO of Elite is Epics president and works for shares of ELTP
--VP @ Actavis/Mikah is a special consultant to EPIC
--COO President Chris Dick replacement will be an expert in 505 b2 development per the CEO
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--minimal debt 3.5 million
--New Jersey(NJEDA) tax credits
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational and adding revenue to the bottom line by making and saving the co. money
--29 employees double of two years ago with yet another opening
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--current API supplier for phentermine has reduced its cost thus increasing profitability and making product more competitive
--Acend Labs has new contracts for methadone
--hydromorphone best quarter ever(ending Mar 31, 2013)
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough (no phase III)
--Naltrexone FDA approved, launch pending (July-Aug 2013) production began late June 2013
--citizens petition with FDA for 100% owned ANDA 12hr ext release brompheniramine pseudophedrine (Drixoral equivalent) antihistamine/decongestant to compete with Avanthi Inc generic
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials against
--undisclosed 100% Elite owned ANDA approx 1 year
--CEO's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO, IR indicating ASAP, may include RS with blockbuster launch partner so to maintain PPS
--CEO obligated to look at ALL buy out offers obligated to maximize shareholder value
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