SurgiLight, Inc. (fka SLGTQ)

[NASDAQ2020]

***** THE NEW ELITE PHARMACEUTICALS, INC (ELTP) *****

--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, microcapsules, granules and powders for pain, allergy, cardiovascular and infection. The Company’s primary focus has become the accelerated development of Abuse Resistant opiods

--The Company’s primary focus has become the accelerated development of Abuse Resistant opiods
-- the development of the abuse resistant technology has become their primary focus, development greatly accelerated, aggressive schedule with clinical trials

--"We have set in motion several initiatives that will have significant impact on Elite's future" CEO
-- SUCCESSFUL pilot bioequivalence study completed on 64 healthy volunteers for ELI-201, the Company's twice daily abuse deterrent oxycodone/naltrexone product.
--approaching 2 million + in revenues per quarter
--Generic Business Cash Flow Positive minus R&D costs two quarters in a row
--R&D cost have quadrupled
--Revenues Increase by 150%
--cheaper sources of API obtained
--large milestones totaling $600,000 from EPIC paid
--no over due orders all placed on time
--Poison Pill 8-A12G filed and a staggerd Board of Directors helps protect shareholders from a hostle take over, independent analyst determined the value of Elite was undervalued and its true value was between $2.10 and $2.75 in 2013
--Moving forward with ELI-154 (once a day Oxy) for Large European Market scale up
--8 launched drugs continue to gain market share
--Nasrat Hakim, Elite's President and Chief Executive Officer has agreed to provide to Elite an unsecured line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of ART product development activities.
--Board member Jerry Trepple took $600,000 repayment of his loan in preferred I shares
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials *ONLY* half used so far
--Billion dollar pipeline-33+ DRUGS including a complete line of 15 NDA and ANDA abuse resistant (ART) opiods plus multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg ' Elite has signed a Manufacturing and License Agreement with Epic Pharma
which will have the right to manufacture, market and sell the 12 approved generics recently obtained from MIKAH. This will allow Elite to maximize their profit potential for their generic business while devoting their resources to the development of their abuse resistant products utilizing their patented proprietary technology. 2-3 of the best transferred ANDAs with minimal competion will be launched first
--first MIKAH ANDA Isradipine will be manufactured by Elite and only has 1 competitor in a 6 million dollar market, will be filed with FDA in Mar 2014
--second MIKAH ANDA Dantrolene will be made by EPIC and also has one competitor in a 12 million dollar market to be filed by June 2014
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--Partnered with CAMARGO for assistance with 505(b)(2)opportunities for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--Mega pilot trial #1 completed SUCCESSFUL 12 hr Oxy/Nal ELI-201 completed in 2013 4 way cross over on 64 voluteers. Elite going it alone so far without partner on 12 hr oxy
trial #2 A pivotal first bioequivalence(BE) study for a *second* undisclosed abuse deterrent product on going results due March 2014
trial #3 Early March 2014 3 tier study 1. snorting 2. oral abuse 3. IV abuse
trial #4 Mar/April 2014 ====$$ *Third* ART Product $$ for "once" a day (24hr)Oxy====
after BE study 3 tier study to obtain * FDA ADT LABELING *
a) snorting trial
b) oral abuse
c) IV abuse
--will be working *5-6 ART opiods* concurrently in 2014
1) Oxy/Nal twice daily ELI-216
2) Oxy/Nal once daily ELI-201
3) Mor/Nal ....(a better Embeda) new patent related
4) Undisclosed ART ( from Jan 2014 trials)

--CEO owns 23% of co. and has challenged team to get the First ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7 Billion dollar market*******, this will pave the way for the 24 hr NDA ELI-216 Oxy/Nal which may only have to demonstrate bioequivalence to the twice a day formula or may require a Phase 3 trial, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
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--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 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. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--ELI-216 is a controlled release 24hr NDA abuse resistant oxycodone/naltrexone
--Multiple potential partners are approaching ELTP and are waiting on results of trials. CEO wants to license ART "after studies and trials completed" making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--FDA likes the pharmalogical approach to abuse resistance
--CEO, the ART is rock solid, innovative, superior and he has not seen a better ART
--1st patent for 2 bead ART 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 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--3rd patent 13/863,764 is allowed for superior Embeda-like ART:
An opioid-antagonist oral dosage form which does not release a therapeutically effective amount of the opioid antagonist when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the therapeutically effective amount of the opioid antagonist. An embodiment of the oral dosage form includes an opioid-antagonist layer coated onto a biologically inert pellet, and a non-releasing membrane coated onto the opioid-antagonist layer. Optionally, the oral dosage form can also include an opioid agonist, such that a method of preventing the abuse of an oral dosage form of an opioid agonist is provided by forming the oral dosage form including an opioid agonist and an opioid antagonist.
--Elites ART is modular, it can be used on ALL opiods just add a different opiod bead to the 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
--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.
--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 Woodcock & Baker 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 and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--Elite owns approx 10% of Novel Labs (Gavis Wintac): Novel and Elite have an ongoing dialog for monetization
--Novel Labs adds to Elite's value estimates for Novel's value range from 10 to 30 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
--CEO and officers being paid with stock
--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
--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
--32 employees double of two years ago
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development on the back burner
--HITK's intermediate for a generic of a branded 100 million dollar market= drug Lots produced
--Naltrexone 50mg launched Sept 2013
--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 with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of 15 abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Once the pilot and pivotal studies completed in March 2014 CEO to go on the road to present the results to viable partners
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo
http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swing for-the-fences

--500 series I convertible stocks created (02/07/14) with a value of 50 million dollars. 105 were used to pay off CEO's drug transfer and Trepple's unsecured loans, 395 available IF NEEDED at a to be determined share conversion price, these can also be used for financing and leverage for a favorable deal for shareholers

--Partner Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission

Six quarters in a row of increasing revenues:

Compare Q2'13 vs Q2'12 Revenue increased +131%
Compare Q3'13 vs Q3'12 Revenue increased +30%
Compare Q4'13 vs Q4'12 Revenue increased +134%
Compare Q1'14 vs Q1'13 Revenue increased +27%
Compare Q2'14 vs Q2'13 Revenue increased +83%
Compare Q3'14 vs Q3'13 Revenue increased +154%




ELTP