Good morning, ladies and gentlemen, and welcome to the Second Quarter Fiscal Year 2020 Conference Call. At this time, all lines have been placed on listen-only mode. Before management begins speaking, the company has the following 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 limitations, Elite's ability to obtain FDA approval of the transfers of the ANDAs or the timings of such approval processes, 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 forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx by the FDA, the steps Elite may take as a result of the CRL, and the actions of the FDA that the FDA require of Elite in order to obtain approval of the NDA. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx by the FDA and the actions the FDA require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future action or performance. These risks and other factors, including without limitation, Elite's ability to obtain sufficient funding under the LPC Agreement, or from other sources, the timing or results of pending and future clinical trials, regulatory reviews, and approvals by the Food and Drug Administration and other regulatory authorities and intellectual property protections and defenses, 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 is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. Sir, the floor is yours.

Thank you, Paul. Good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am Elite’s President and CEO. This is our earnings call, and our CFO, Mr. Carter Ward will give us a summary of the company's financials, after which I'll come back with the corporate update and answer a few of the questions you've submitted to Dianne. Mr. Ward, you have…

Thank you, Nasrat. Good morning everybody and thanks to everyone for calling in today. Yesterday, we filed our 10-Q for the quarter and six months ended September 30, 2019. So we're on a March 31st fiscal year, so the September quarter is the second quarter of the fiscal year ending March 31, 2020. So we're halfway through our 2020 fiscal year. The Q is available on the Investor Section of our website, which is elitepharma.com, as well as sec.gov and the many other websites that provide links to our filings. If you haven't gone through the Q yet, please get a copy from elitepharma.com or any one of the other sites. I'm going to briefly take you through some of the key parts of the financials, providing some analysis, context and insight into the numbers. And as always, we've received questions and comments from shareholders and Elite followers. And as I go through my presentation, I'll do my best to address those that are financials related as well. So, three months ago, we had our conference call and our June financials back then were interesting, and these financials are just as interesting or maybe even more interesting. So I'm going to start with the P&L and specifically on the revenues. On the P&L, so first of all our revenues for the quarter ended September 30, 2019 were $4.6 million. That's compared to $1.4 million for the September 2018 quarter, year ago. So it's a $3.4 million increase or 240% year-on-year increase, what a difference from a year ago. Looking at revenues on a quarter-to-quarter basis, and you'll note that this September 2019 quarter was also $1.2 million, or 35% above the June 2019 quarter. So June was a really good quarter for us, and September beat that by 35%. So no matter how you measure it, this was strong performance. Drilling down into the revenues, there's two factors that jump out. Number one, new products have performed extremely well. And number two, our established product lines had across the board growth. First, let me start with the new products, and those are the immediate release, generic Adderall, and the generic Dantrolene, both of these were launched during this fiscal year, actually, towards the end of the June quarter. So they had a full quarter of operations in the September quarter. So these two products, by themselves, are responsible for approximately two-thirds of our revenue growth, and they generated by themselves almost double the total revenues earned during the September 2018 quarter. So what we did last year in September quarter, these two products all alone almost doubled that. So we were expecting these products, which are marketed by our alliance partner Lynette. We were expecting them to make significant contributions. They've done just that. Now a couple other factors to keep in mind, regarding these new products, launched this year. First of all, these products are new in the market. Our alliance partner Lynette has done a tremendous job gaining market share so far, but we are optimistic of achieving even further increases in market share over time. And second, while the revenues to date have mostly been from manufacturing, should also remember, that there's a profit split component to these products. Profit splits; they depend on the timing of end market sales and various other factors. So there's a lag of around three to up to even nine months from Elite manufacturer of the products to our receiving profit splits, which are derived from their end market sales by Lynette. So this is a good indicator of the potential for continued growth, in future revenues, even above the current level. So there's a lot to be positive about our new products. But these products accounted for two-thirds of our revenue growth. And so that's only two thirds, what about the other third? Well, that growth came from our established product lines. Now, these product lines, I call them the established products, they've been in the market for anywhere from two to up to eight plus years, they have achieved, across the board revenue growth as well as compared to the prior year. Every one of these products was up. Naltrexone and Phentermine, marketed by TAGI, they were up. Isradipine, Phendimetrazine and Trimipramine and methadone marketed by Glenmark also up, each one of them. So the takeaway in revenues is that, the established products generated significantly increased revenues by themselves, and when you add in the new products, which are performing at and above expectations so far, you get overall revenues which are more than, triple where they were just a year ago. In addition, there is still quite a bit of upside possible with regards to future profit splits and increased market shares for our expanding product line. So moving down to P&L, let's talk about research and development expenses, which were $637,000 for this quarter, 2019, as compared to $2.5 million for the September 2018 quarter. So year-on-year that’s a decrease of approximately $900,000 or 75%. So the year-on-year decrease, it is large, but there's no trend indicated or inferred. You should not infer anything from that. R&D costs are driven, by the type and the timing of underlying activities. Last year there was a large spends of development of the products which we'll launch this year. And you see the effects that that those launches have had on us. As well as another product in our pipeline, which has been filed and it's nearing its GDUFA date next month, December. And Nasrat will talk a little more about that. But there is significant upside relating to that product as well. This year, 2019, the type and level of product development activities were not as extensive as last year. But we do expect the future quarters to see increased R&D expenses in relation to the ongoing development of other products in our pipeline. And that's product development something Nasrat is going to go into much more detail than I will. But the takeaway here is that the decrease in R&D expenses is viewed as temporary. R&D is the lifeblood of all pharma companies, so we do not expect this level of decreasing costs to be maintained. So to sum up -- sum up the quarter, we followed what had been our strongest quarter to-date in June. We followed that up with an even stronger quarter in September. Revenues have more than tripled since last year. And they're being earned from a solid foundation of diversified revenue streams, consisting of well established products which are growing, as well as newly launched products, which are showing strong potential for even further increased revenues. In addition, we have a pipeline consisting of a product that's nearing commercialization, plus additional product lines, which are on schedule for commercialization in 18 to 24 months, positioning Elite for continued growth. That's it for me. Now Mr. Nasrat Hakim, our Chairman and Chief Executive Officer, he is going to give his updates and his comments as well.

Thank you, Carter. I'll start by covering Elite’s ongoing activities and the progress on our pipeline and strategies. First, a word on our revenues. Revenues continue to grow. Our growth plan is on track with $4.6 million in revenues this quarter. I said during our last call, last quarter that based on projections provided by our sales and marketing partners, we expected this quarter to be better than the previous one. We have surpassed that revenue of $3.4 million. This is our best quarter ever, and the $4.6 million in revenues is more than three times the quarter ending in March 2019, and 240% increase in revenues over the same quarter last year. Our revenues for the last two quarters are $8 billion. That's 3.4 plus 4.6. Our annual revenues for either the last two fiscal years were $7.5 million and $7.6 million. We generated higher revenues in the last two quarters than either of the previous three years. We expect increased revenues to continue, contingent upon the bid and projections committed to by our partners. There's a marketing partners, and DEA issuing Elite beneficiary quota. Second, regarding the ANDA approvals and filings, we launched Amphetamine IR. We have been very busy with commercializing that launch. And the approval of Amphetamine IR and other products, Lynette is our partner for this product. Amphetamine IR sales jumped in September with Lynette securing a contract that made tremendous difference in September and working on another substantial new customer soon. Amphetamine IR has been the driving growth behind what happened in the past quarter. Launch of Dantrolene also took place last quarter. Dantrolene has launched and the growth is still expected to grow at least minimally over the next couple of quarters. Extended-release central ANDA, the FDA is reviewing the extended-release central nervous system, ANDA and we expect that this product will be next key product for Elite. This product was co-developed with SunGen and is licensed by Lynette for commercialization. We are hopeful that the FDA will provide the additional communication to us by the GDUFA date, which is mid December. We will update you again upon approval and launch of this product. Loxapine. We file prior approval supplements for Loxapine to transfer it to Elite and to add a new API supplier. The feedback from FDA was all the data is adequate from Elite side. They conducted an inspection of the API supplier, which they passed were two minus 483, all the necessary paperwork was submitted to FDA last Monday and we expect approval of that product in two to three months. We are discussing a potential marketing partner right now for that product as well. Antibiotic tablets ANDA was developed and filed with our partners SunGen and is under review by FDA right now. The GDUFA date is later this month. I will address opioids in general instead of breaking them down by center and I will go in particular later on when I go through the Q&A. As we've discussed before, because of the current negative environment for opioids, Elite has de-emphasized these products. We have stopped selling some and delayed the launch products, due to lawsuits and the changes in the landscape that everyone is aware of. And I'll say a little more about this during the Q&A section. From the development standpoint, we have one critical product that we have developed with SunGen that has an IMS data for $1.5 billion and upon achievement of key milestones we will update you on these developments. Shareholders meeting. As a reminder, our shareholder meeting will be held on December 4th, at the Residence Inn by Marriott in Orangeburg, New Jersey at 10:30 A.M. You should all have received notices of this meeting and your proxy to vote. So please vote. If you have any question about the proxy, please call or email Dianne Will, you will find her contact information on our website. The proxy includes election of directors, an increase in authorized shares, appointment of auditors and approval for management incentive plan. The increase in authorized shares allow Elite to execute on our initiatives and to grow our business. It provide shares to cover the company's obligations for the series D and it will allow Elite to develop further products and to cover working capital needed to launch our many new products. Without this, we would need to limit our growth, our ability to do strategic deals, which together would limit the growth of the stock. We hope to see all the shareholders on December 4th at our shareholders meeting. You've all submitted a lot of questions to Dianne that we have grouped them. And I'll try to take most of them on except for one, Carter will answer, because it’s financial. The first question is for me. Nasrat, why do you want to cover your preferred shares -- convert your preferred shares to common shares? How does this benefit you and the company? It's actually a straightforward question. This is a contractual obligation where I loan Elite shares when they don’t have any. Now that they're going to have shares they return them back to me. It's that simple. There is no benefit on cost analysis. It's very simple when you borrow something, you return it. However, this is very advantageous to Elite to return the shares, because if they don't, the first, second and third years, the shares accrue an interest, but on the fourth year, Elite will have to pay 20% interest on the shares. So it's an Elite’s best interest to return them now. Furthermore, I'm the best backup for Elite and the last time when Elite had no shares and they needed to sign a deal with Lincoln Park, they came to me and I forfeited my shares. I cannot do that when these are in a J-series. They have to be in common shares. So this is actually very advantageous to Elite to do so. Second question is financial, Carter if you take that.

Okay. We’ve got a financial question. Most questions go to Nasrat. I don't get too many, so thank you for that. The question is, can you address the gross margin for Q2. It is much lower than in previous quarters. Revenue is up approximately 250%, but gross profit is up only 60%. Is this the gross margin, we should expect to see moving forward for the portfolio? Will it normalize once the new products mature? That's a good catch. And you're on target when you talk about normalizing when new products mature. So let me explain, the key point here is that Elite revenue cycle consist of two phases. The first phase is when we manufacture and ship product to our partners. When that happens, we book revenue, which is on our P&L as manufacturing fees. We also book costs of revenues. That's also on the P&L. And that's just the straight cost accounting, material labor overheads absorbed by the products that we just shipped out. That's the first phase. The second phase of our revenue cycle, that's what we earn when our partner sells the product into the market. That's different from when we ship it to the partner. We get a share of the profits earned from these sales and that's in addition to what we get from the manufacturer. And that's shown on our P&L as licensing fees. So when you're looking at the difference between manufacturing and licensing fees, the main factor to keep in mind is that these revenues occur at different times. Manufacturing revenues are earned when product is shipped and license revenues are earned when they are eventually sold into the market. That date will always be later than our ship date, usually lagging behind the ship date by a month or two and in some cases up to nine months, depends on the product. So this timing difference in each phase of our revenue cycle is especially evident when a new product is launch like [indiscernible] in this quarter. This quarter we ship large quantities of Amphetamine IR and Dantrolene. As Lynette sells into the market, Elite will earn license fees that are based upon the profits achieved by the sales of Lynette. So if you want to view this as a pipeline, the shipments today they go into a pipe as manufacturing revenues and they'll eventually over time come out as profit split revenues over the next couple of quarters. That's what's going on. Eventually after a few quarters, an equilibrium is reached, where the amount of manufacturing -- the dollar amount of manufacturing revenues that are going into this pipeline, they correlate more with the amount of profit split revenues coming out, and the timing differences are less pronounced. So one other thing to note in regards to this subject, it’s also right on our P&L statement. This quarter 2019, we had 4.2 million in manufacturing fees and only 465,000 in profits splits. Last year 2018, for the same quarter, we had 800,000 in manufacturing fees and 557,000 in profit splits. So the manufacturing revenues will way up this year, but the profit splits were down. And this perfectly demonstrates the lag between the shipments and the end market sales, and to give a good indication of the magnitude of the profit split revenues that are on our horizon, as these products are sold into the market.

Thank you, Carter. Next question is a pool of multiple questions really, what is the status of Elite CNS -- Central Nervous System extended-release. A lot of people ask about that I've already addressed it, but I’ll address it again. We are hoping that the FDA will approve the product on the GDUFA date that is in mid-December. We answered the FDA’s questions few months ago. As you recall, this product was supposed to be approved in March. We had the government shut down. The FDA came back. We didn’t have time to review some things and do one more test. We did all of that and submitted in April. Okay. We've addressed all of their concerns, about two months ago they asked us for labeling updates, which we took care of that. Now we await their decisions in mid-December. You will sure -- surely be notified because this product is of extreme importance to us, if we get approval in mid-December. What is happening with Elite’s generic opioids? Again, this was a pool of about 10 questions. One on Percocet. Is Elite, an opioid hold mode on Norco? Why was this move to discontinued? APAP with Codeine, does the company have a distributor, and some questions about SequestOx, the ART technology, lawsuits and Elite? So I'll try and address all of that in one answer that's broken down into sub-parts. As you all know, the opioid litigation has been covered extensively in the news in recent month. Elite does not want to risk litigation regarding opioids. And so we are not launching any opioid products at this time. Since we cannot utilize these products in the near-term, we are evaluating opportunities to utilize these assets, and we will update stakeholders when appropriate. This uncertainty about opioids also means, we are awaiting -- we are waiting before we invest any more money in SequestOx or in the ART technology. Currently, the generic opioids continue to dominate the opioid market, limiting the attractiveness of the abuses deterrent products. Doctors continue to prescribe cheaper generics over abuse-deterrent generics. If this change, Elite will reevaluate our strategy for these products. Let me say a few more words about first the generic opioids and second, our technology. We have several generic opioids and we cannot utilize them. We're just holding on to these ANDAs because of the lawsuits and the fear that our partners have, they maybe sued and Elite's unwillingness to take on the liability. Except for methadone, which is used in methadone clinics, to help people break the habit of opioids, because of its uniqueness. All others have been a burden. The burden they bring is REMS fees. We have to pay fees on these products. You have to enroll in REMS programs. Also, another burden is the increased number of ANDAs. Right now, we have 18 ANDAs. If we cross to 20, then we will pay about $1 million more…

About $2 million.

…about $2 million more in GDUFA fees. So, you don't want to cross that threshold unless you have a product that's going to bring in that kind of money or service products that do that. Okay. So, by investing in these products, it makes sense. And this is what we are thinking about at this time, because that eliminates all of these detriments I just presented and also gives Elite a cash infusion. Regarding the -- our technology, we believe in our technology very, very strongly. But before we jump into spending millions of dollars on SequestOx to prove a point, we need to ask ourselves a question, why did Pfizer spend $75 million to $100 million on Trexeca [ph] and not launch it. They got approval and did not launch. Why did Inspirion [ph] launched their approved RoxyBond [ph], which was approved in 2017. In today's climate, if we invested in SequestOx and our technology instead of amphetamine, the central nervous system ER, the attention deficit disorder ER and other products you know about, there're many you don't, we would be bankrupt just like Insys Pharma and Inspirion [ph] and others. So, I think, that we are focused on what is important for us and the stockholders and we are delivering on that. Next question is what is the next Elite partnership with SunGen? We have couple of products in the pipeline, both on -- including the one I mentioned 1.5 billion in IMS data. And our partnership has been very fruitful. We have done about five products with SunGen right now and willing to do more business with them in the future. However, Elite is not locked into SunGen only. Our model is that we work with partners or we go at the product ourselves. SunGen is great, but there are other opportunities out there. What is most long term plan for Elite? Okay. First and foremost, Elite will continue to develop, file and launch products with partners and without partners, as I just said, with respect to our good partner SunGen. As discussed earlier, we are anticipating approval for the central nervous system in ER. And we have more products in the pipeline. Second, Elite has faced many challenges in recent years. We have managed our way through them. That includes regulatory, marketing and growth and the opioids crisis as well. No doubt we will continue to face other challenges, as in the past. And we will overcome them. Looking back, Elite has made tremendous progress since I took over. The facility has expanded and improved. We have added personnel that deepened our understanding and experience and expertise in manufacturing, regulatory, pharmacovigilance, quality and analytical. While doing this, Elite has been developing on filing new product, which has led to the revenue growth that you heard about today. An important milestone that we look forward to accomplishing is profitability. You will see that, cash flow from operational activities was only slightly negative this quarter and was slightly positive the last quarter. We are focusing on future -- on further improvement in cash flow going forward. So we can achieve profitability. Another important milestone will be uplifting in NASDAQ, which will require solid fundamentals and ongoing profitability. We look forward to achieving that over the next one or two years. And for stockholders, as we move forward, we expect the price to reflect that this accomplishment and reward the stockholders. Finally, long-term or short-term, I have the same philosophy. We work for one of the greatest businesses in the world, the pharmaceutical business. The important part of the statement is that, it's a business. And as such, we have to make every decision that leads to survival, profitability and prosperity, regardless of emotional attachment to a specific platform. Unlike many companies that went bankrupt, we have survived, profitability is only one ER away and prosperity will follow. This was the last question on my list today. I will turn this back to Paul. And I hope to see you all on December 4. Thank you. End of Q&A: 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.