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Executives

Chris Dick – Chief Operating Officer and President

Jerry Treppel – Chairman and Chief Executive Officer

Carter J. Ward – Chief Financial Officer

Elite Pharmaceuticals, Inc. (OTCQB:ELTP) F3Q13 Earnings Call February 19, 2013 10:00 AM ET

Operator

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals 2013 Third Quarter Conference Call. At this time, all lines have been placed on a listen-only mode and we will open the floor for your questions and comments. Before we begin the conference, let me read the forward-looking statements.

This conference call contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects if any on future results, performance or other expectations that may have some correlation to the subject matter of this conference call.

Listeners are cautioned that such forward-looking statements involve risks and uncertainties including without limitation, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements.

These risks and other factors, including without limitation the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses and the Company’s ability to operate as a going concern are discussed in Elite’s filings with the Securities and Exchange Commission, including its reports on Forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.

It is now my pleasure to turn the floor over to your host Chris Dick, President. Sir, the floor is yours.

Chris Dick

Thank you, Kay. Thank you everyone for participating today. We also have in the call today Jerry Treppel, Elite’s Chairman of the Board and our CEO; and we have Carter Ward, Elite’s Chief Financial Officer.

Last week, Elite filed its 10-Q for the quarter ending December 31 and we issued an earnings press release detailing the Company’s quarterly results. Hopefully you’ve all had a chance to view this by now, but if not a copy can be obtained by contacting Dianne Will at 518-398-6222, or by viewing it at our Company’s website which is www.elitepharma.com under the Investor Relations section.

I’m going to begin by providing an update on the Company’s operations and then I’m going to turn it over to Carter for a review of the financials. And after that Jerry can provide his comments. And at the end, we’ll open up the floor for questions.

So Elite’s revenues for this quarter ending December 31 were $668,000, a 6% increase over the previous quarter, that’s the quarter ending September 30. This increase was in spite of the holiday periods which can reduce the product shipments. Elite’s product portfolio and that has eight products that it manufactures, Elite has five approved ANDAs that are/will be sold by TAGI Pharma with revenue from two of these products generating revenue for this quarter. Elite contract manufactures two products, one product for Ascend and one product for Actavis. The Actavis product was launched in the second half of the third quarter. Elite also manufactures an OTC product with ECR Pharmaceuticals distributes.

So comparing revenues from a quarter one year ago, manufacturing revenues have increased over 200% and royalty revenues have increased more than 700%. Clearly, Elite is growing substantially as we continue to add products. Elite is preparing to launch three new products for its portfolio, two strengths of the Phentermine capsules and an Naltrexone tablet product.

So let’s talk about the commercial products that Elite is now manufacturing. First, the generic pediatric products, the products used to aid weight loss. Elite manufactures three products in this category, the first of the products in the category, Elite’s first generic product, it has been on the market the longest. This product continue to grow this quarter, the raw material issue has been resolved. Elite is paying a higher price for the material, but with the supply secured we expect continued unit revenue growth for the product.

As announced last quarter, Elite received approval for two strengths of a new product in this category. The launch of these two products were delayed pending the resolution of the raw material sourcing mentioned above. Even after resolution of the issue, initial raw material supply was used first to rectify the backorders on the older tablet product mentioned above since that product was already on the market. Elite do not have sufficient material until now to manufacture the launch quantities for these two new products. These batches are being made now and first batches are expected to be shipped next month.

We contract manufacture fourth product in this category for Mikah Pharma and is being distributed by Actavis as mentioned before. We shipped our first batches this quarter ending December 31 for the launch of the product. We expect this product will add important revenue for Elite to lower Elite to see trends on the product.

The generic pain product, the first product in this category has grown since its launch last year. The DEA quota limitations however reduced what we could ship this quarter ending December 31. Now with our initial 2013 quarter in place, additional shipments have resumed. Assuming adequate quota, this product should continue to grow this year. Elite contract manufacture its second product in this category for Ascend. Sales were flat compared to the previous quarter as Ascend worked on inventories, we are seeing our sales begin to pickup again now in the current quarter.

Allergy product, Elite manufactures Lodrane D in this category. Lodrane D is an OTC product developed with and sold by ECR Pharmaceuticals. This is one of our smaller products last quarter. We do not yet have an indication how this product might perform this year. Perhaps by next quarter, we’ll have a better idea.

In the alcohol addiction, Elite added a new generic product in this category Naltrexone 750 milligram tablets, we announced the approval of this product. We’re now waiting for materials to arrive to begin manufacture of the batches for the launch. First batches are expected to be shipped next quarter, the second quarter of this calendar year.

So in summary, each of these products launched fairly reasonably within the last 18 months and we believe each products still has growth (inaudible). In addition to these commercialized products, Elite now has two products that are pending FDA approval. These products include an ANDA filed by Elite and an NDA filed by Epic Pharma. The Epic Pharma product is one of the products developed under the Alliance Agreement between our companies. We cannot predict the timing of the FDA approval for any of these products.

Elite continues to work on its pipeline of other products for future filings that include both ANDAs and NDAs. The NDA products that Elite is collaborating with (inaudible) include an extended release Lodrane product with ECR Pharmaceuticals, and an undisclosed NDA with Mikah Pharma. Elite is also collaborating with Hi-Tech Pharmacal on an intermediate for a generic product.

There are other products too that Elite is developing for itself including of course ANDAs and NDAs based (inaudible) sustained-release and abuse-resistant technologies. These are all medium term to long-term opportunities for Elite. And as a reminder, once again regarding pipeline products, Elite does not disclose specific product milestone beyond what would be considered material events or signing up material agreements. If there are projects which Elite has not provided progress reports on, it’s for competitive reasons.

Regarding our facility expansion, as Elite recently announced, we are now using our expanded facility. The additional suites provide new capacity for expanding line of products. The expansion also allows Elite to make larger batch sizes, which resolves efficient production. We have also begun using the packaging line in the expansion. We are packaging some, but not all of our lots at this time. With time and experience (inaudible) to pick up the other batches.

A few miscellaneous items, regarding financing, Elite continues to look for financing primarily to provide capital to allow Elite to conduct viral studies on our own for our internally developed products and for general business purposes. We are not sure of the timing of this financing. It’s taken much longer to execute than expect it. If we are unable to execute this transaction in an expeditious manner, we will seek other alternatives.

I want to make it clear that we are seeking additional capital to promote growth, not to maintain the existing business. As Carter will discuss next, Elite’s burn rate is falling and we are approaching breakeven for the existing business.

Our second item, Ram Potti resigned from the Elite Board at the end of this quarter ending December 31. Ram is one of the principals from Epic, those who are likely to know him – closely working with Elite and helping Elite over the recent years. Ram indicated the resignation was for personal reasons and that he will continue nevertheless to work with and help Elite in his continuing capacity at Epic. We very much appreciate Ram’s time and assistance over the years and wish him well.

Some investors may also have seen that there is some selling by insiders. It was a modest amount and it’s primarily by Epic. Epic sold a small part of the common stock at hold and then used as proceeds to execute some of the warrants they hold. By exercising the warrants, Epic has maintained the number of common shares, no new dilution and Elite received cash from the exercise of the warrants that we can use for general corporate purposes.

Finally, let me mention our patents, because most of you know we hold a patent on abuse-resistant that was allowed last year. We have other patents pending including a related patent to the allowed patent and other development patents. For now, we can only report that we are accurately pursuing this patent in the U.S. and in certain territories outside the U.S. and we will update you when we have something more to report.

In summary, Elite continue to make substantial progress during this quarter, both financially and in product development, including the following. First, financially, Elite continue to trend of increased revenues. Of the products launched last year, we continue to see a growth trend for all of them. Second, Elite continues to add new products. We have three more products that we are currently getting ready for launch. This will make eight products including the products we contract manufacture.

And third, in Elite’s pipeline, there are two final products, for which Elite is awaiting FDA review and approval for it. And Elite ANDA and an ANDA filed by Epic Pharma from our Alliance Agreement. And fourth, Elite began four years of its new facility this quarter, a key goal for us. And finally, Elite has progressed its pipeline of other products, including our sustained-release and abuse resistant products and other ANDAs in collaborations on ANDAs and NDAs with our various partners. These new products form the basis of continued strong revenue growth featured for Elite.

So with that, let me turn it over to Carter for a discussion of the financials this quarter.

Carter J. Ward

Thank you, Chris, and thanks once again to everyone calling in today. We appreciate your interest in Elite. Last week, we filed our 10-Q for the three and nine months ended December 31, 2012. We are on a March fiscal year, so this is the third quarter of our 2013 fiscal year. Financials are available online with links on our website elitepharma.com as well as the other usual sites like sec.gov, Yahoo, MSN Money, et cetera. So hopefully most of you would have had a chance to look at our financials.

Now, our financials reveal the sustained growth of the revenue streams which we have brought online over the past 12 to 18 months. Quarterly manufacturing and profit revenues were $556,000 for this year’s quarter, that’s almost triple the $190,000 in these revenues during the December 2011 quarter.

I’d also like to point out that the December 2011 quarter was the first quarter which we had no manufacturing or profit split revenues related to the discontinued Lodrane extended release product. So this tripling in revenues on a year-on-year basis should really give you a good picture of the growth in our revenue streams. Overall revenues including lab revenues were just under $700,000 for the quarter this year, that’s an increase of 32% from total revenues of $510,000 for the December 2011 quarter.

Moving down our P&L statement, we had an operating loss for this quarter of $274,000 as compared to a $431,000 operating loss in the 2011 December quarter. So we reduced the operating loss by about a third, that’s quite significant.

Included in our operating loss were increased regulatory fees and higher insurance costs most notably medical insurance for our employees. In addition, we began hiring additional manufacturing and regulatory staff to enable us to meet the demand of our growing operations and to also comply with the increased regulatory requirements. We expect the continue growth in our product line and revenue streams to be sufficient to absorb these increased costs, the fact (inaudible) at our regulatory and employee cost have risen and such [increases] are not expected to be temporary.

Now, let’s move to the cash flow statement. For the nine months ended December 2012, we had $1.5 million negative operating cash flow. We invest $246,000 in facility expansion and intellectual property, and we received total of $1.1 million from Epic for the strategic Alliance Agreement from the exercise of cash warrants and from loans from our CEO.

The negative operating cash flow was due to combination of losses from operations, plus large increases in receivables and inventories. This increase in receivables and inventories totaling more than $800,000 resulted from our growth. We are adding products. We are increasing production just what we want and are striving to do. But this strong growth does require increased working capital in the form of funds being tied up receivables and inventory, and our cash flow very clearly reflects that situation.

Further down looking at our cash flow statement as well as our balance sheet, you may also notice that we had an unusually low cash balance as of December 31, 2012. That was due to a large number of receivables approximately $350,000, which were due as of December 31 that were only collected during the first phase of January 2013. This looks like our customers wanted to draw cash on their books at their year end and then paid us right after the New Year. The timing difference of a few days which happened right at the end of the quarter is not really unusual, it’s just something that (inaudible) the normal course of business.

Just wanted to point out one more thing on our cash flow statement. Operating cash flows for the nine months of this year were negative $1.5 million as compared to negative $789,000 for the nine months in the prior year. At first plan, it may seem that things have gotten worse, but they haven’t. So what’s the reason for this? Well at this time last year the 2011 quarter, operations were just starting to rebound from their lowest point. We had liquidated stock receivables with these items decreasing by almost $300,000 during the nine months of the prior year.

A decrease in these items results in a positive cash flow. This year is the exact opposite, inventory and receivables have increased by more than $800,000, increases in these items result a negative cash flow. So that’s a swing in cash flow of almost $1.1 million. But this year as compared to last, production is increasing, requiring greater inventory and sales are also increasing resulting in higher revenues and higher receivables. So last year, Elite was shrinking and this year we are growing. That’s what you want to have happen, but as I’ve said many times it’s also something that requires greater working capital and finance.

So in summary, our financials continue to contain metrics that (inaudible), revenues are increasing, losses are decreasing, we are moving towards breakeven and expect that trend to continue. The new product lines are growing nicely and we also have three recently approved products that are scheduled for launch.

So with that, I’d like to introduce our Chief Executive Officer, Mr. Jerry Treppel.

Jerry Treppel

I’d like to thank everyone for listening to the call. It is my pleasure to thank all the employees of Elite and also Epic that have helped us get to this point. I think we should all take a moment and try and recognize at this how much this small company of just 26 people currently has achieved in the last 18 months. And it’s been done under significant resource constraints.

And I just want to make everybody aware of that and again to thank Yeoman’s effort on the part of everybody. I’m not going to repeat what Chris and Carter said, I’d just perhaps want to outline some short-term goals that we have. No new facility opens in the drug industry at peak efficiency, neither did we. There is more to be done to make it as cost-effective efficient as we can, that will be done. We are going to introduce the three new products and seeking additional financing is important for us.

And as Chris said, not so much to maintain the current business and we’ve given some broad outlines about when we expect that to be breakeven on a cash basis. Just to remind you, we said when quarterly revenues get to around $1 million per quarter, that’s about where our business started to breakeven on a cash basis. This quarter revenues were $700,000 so it gives you a feeling for how far we have to go. We believe that with the growth of the existing products and the addition of the new products, we’re going to get there and that’s a good thing.

The additional capital really has grown capital to a lesser extent for the existing business and most of it for the development of our internally developed products which primarily are the abuse-resistant products. Only thing that we really can’t do on a conference call is, is give you much detail about where that development is, though we might comment in the press release site, try to indicate that we will probably, those are along that people think. At this point at least one of those products is reaching the point where we expect it will go into clinical trials relatively near future.

It’s interesting to me that someone who worked on Wall Street for 25 years and disparity in valuation between companies like Elite and other companies involved in development of abuse-resistant products like Pain Therapeutics, Acura, what it says to me is that, the investment community doesn’t really believe us yet, but these products are going to be real. Well, there is lot of people in this company including myself and Chris and Carter, and our Chief Scientific Officer who have been paid a significant amount of stock because we do believe that. And that market has developed in a way enormously to our advantage, and we think we have an officious technology that is in a lot of ways superior to approaches that other companies are taking.

So with that, I’ll open it up to questions.

Question-and-Answer Session

Operator

(Operator Instructions) There are no questions in the queue at this time.

Chris Dick

Okay. I’d like to thank everybody for listening, and should you think of any questions later on, you can certainly give us a call. Thank you.

Operator

Thank you. Ladies and gentlemen, this does conclude today’s conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

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