Good morning, ladies and gentlemen. And welcome to Elite Pharmaceuticals Conference Call. At this time, all lines have been placed on listen-only mode. Before management begins speaking, the Company has the following statement. 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, of 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 involving risks and uncertainties including, without limitation, 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 the approval, if at all, of SequestOx by the FDA, the steps Elite may take as a result of the CRL, and the actions the FDA require of Elite in order to obtain the 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 factors 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 the 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 Mr. Nasrat Hakim, President and Chief Officer of Elite Pharmaceuticals. Sir, the floor is yours.

Thank you, Miles. Good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am Elite's Chairman and CEO. This is Elite's earnings call. So, our Chief Financial Officer, Mr. Carter Ward will give us a summary of Elite's financials. As always, I will take this opportunity to give you a high-level summary of Elite's business and an update on the Company progress since our last meeting. And I will answer few of the questions that you have submitted to Dianne. Mr. Ward, floor is yours.

Thank you, Nasrat, and thanks to everyone calling in today. Speaking to you from snowy Northvale, New Jersey this morning. Yesterday, we filed our 10-Q for the quarter ended December 31, 2018. So, we're on a March 31st fiscal year. That means the December quarter is the third quarter of the fiscal year ended March 31, 2019, so 2019 fiscal year. The Q is available on the Investors section of our website, which is elitepharma.com as well as sec.gov and many other websites that provides links to our fillings. So, if you haven't gone through the Q yet, please get a copy from elitepharma.com or 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. As always, we received questions and comments from shareholders and elite followers, and I'll do my best to address those questions that are related to the financials as well. So, let's start with the P&L. profit and loss statement. Revenues for the quarter ended December 31, 2018 was $2.7 million as compared to $2.5 million for the December quarter of the last year, 2017. So, year-on-year, that's just over a 6% increase. The $2.7 million of quarterly revenues is also almost double the $1.4 million in revenues, which were earned in the prior quarter, the September 2018 quarter. This substantial jump in revenues in a single quarter is due mostly to Methadone, which was launched towards the end of November 2018. This product was approved during the September quarter but shipments didn’t begin until this December quarter. But, it goes beyond just shipments of Methadone. We've manufactured and shipped Methadone for many years before 2018. But, this isn’t the same Methadone, and that's where the similarities end. Prior to 2018, we were just a contract manufacturer of Methadone. And when you’re contract manufacturer, that means we didn’t own the product. And accordingly, the future and potential upside of the product was very limited for us. These limitations were clearly evidenced when the contract to manufacture that Methadone expired, and it was not renewed. That's something to be expected, and it's common occurrence in the pharma industry. And that's why we spent the time, the efforts, the resources in developing and getting approval for our own Methadone product. So, it got approved. And now that we own the product, we have licensed the marketing rights to Glenmark USA. We earn manufacturing revenues that are comparable so far to the contract manufacturing of the path. But, now unlike contract manufacturing, we also earn a substantial share of the profits accruing from the in-market sales. This December quarter saw the first shipments of our own Methadone and future quarters will reflect additional profits earned in relation to Glenmark selling our products. We’ll have manufacturing revenues, as well as profit split revenues. I received a question on when we’ll see profit splits from Methadone. The short answer is, that depends on the timing of the in-market shifts. Based on our experience with other profit split arrangements of other products, most of the product is sold into the market within three or six months, and then there is some other -- another month or so for collection of invoices issued and profit splits are paid in a certain schedule, which means that we will be earning revenues over a three to upto nine months after shipment. Now, our Methadone is just hitting the market, so the profits should start accruing during this quarter, the March 2019 quarter, the one we are in now, and it will pick up -- profit splits will pick-up in subsequent quarters. The important thing is that the product continues to be made, it continues to be shipped and that our marketing partner Glenmark continues to sell. Now, the indications from Glenmark so far have been positive, and we are quite optimistic about this product. Our other products also did well during this quarter, especially in comparison to the September 2018 quarter. Naltrexone and Phentermine sales were up, they remain strong. We're also transitioning the marketing of Isradipine and phendimetrazine from Epic to Glenmark. And we are optimistic that these products will continue to perform well and even improve with Glenmark's resources and their outstanding capabilities now being a factor. All-in-all, it was a good quarter revenue wise and the results. These results do not include contribution from our recently approved generic Adderall. Nasrat will have more to say on the generic Adderall on the commercial launch plans, but from a financial standpoint, this product has not yet contributed to earnings, but I expect that that will change in the near-term. The takeaway from revenues is that they are up. Methadone starting to contribute. And we have three other approved products that have not yet begun to contribute to revenues, which is a factor that may bear on future results, especially the Adderall. Next, on the P&L statement is research and development expense, R&D, which is as usual, our most significant expense line. R&D expenses were $2.5 million for this quarter, December 2018, compared to $2.3 million for the last year's December 2017 quarter. That's a 7% increase in total spend. I think, I say this every quarter, but always remember, the amount spend on R&D is important but just as important is what it was spent on. 2017 and the prior year, R&D dollars were spent on generic Adderall, which has been approved; generic Methadone, which has been approved; generic Norco; generic Percocet also approved; and another central nervous system product, which was filed and [technical difficulty] approval. Methadone has been launched already and it's contributing revenues and profits currently. Adderall and the other products that are just named, they are approved, and I expect them to contribute subsequently. And so, that's what 2017 R&D spend, what those dollars have yielded, it's quite nice. In 2018, this year's quarter, this year's R&D dollars, they’re being spent on that CNS products, central nervous system product, which is nearing approval, and anti -- it's also being spent on antibiotic products that we recently filed. Alternate suppliers for some critical raw materials that have been approved plus a few other products which will result in filings next year and approvals after that. So, it's important to keep our pipeline stocked just like any generic pharmaceutical company and keeping that pipeline moving. And that's what's happening. Things are going into the pipeline and coming out as approved product, and they're finally starting to come on line as commercial products. Takeaway here being to not just look at the revenue and the R&D expense numbers, but also to look at what we are doing and what we are achieving. We're getting products approved. These products are starting to contribute. We have products already filed and working their way through the FDA, and we continue to steadily develop even more products for the future. All of that is underway, it’s ongoing, it’s moving, and our revenues are growing as they should. So, all very positive factors in our financials. So, now, our Chairman and Chief Executive Officer, Mr. Nasrat Hakim, he would like to give an update and his comments.

Thank you, Carter. I’ll start with a summary of the things I'm going to talk about and then I'll go into a little more detail. 2018 was a solid year for us. On the approval front, in 2018, we received approvals for Methadone, Percocet, generic Oxy/APAP, Norco, generic Hydro/APAP and Amphetamine IR Adderall. We filed an extended release central nervous system product with IMS data of about -- sales of about $1.6 billion, an antibiotic product Amphetamine IR Adderall which got approved by the end of the year with IMS data of about $400 million and APAP with Codeine. In addition to all of that, we also partnered with Glenmark on sales and marketing, and launched two products in 2018 in Q4. We transitioned Elite’s products from our old partner to the new marketing partner, Glenmark, which has greater reach and better value and results for Elite. We partnered with a licensing partner identified for these two central sponsor nervous system products. And we’re in the process of finalizing several marketing agreement. So, I cannot mention who that is yet, and I'll speak about that a little more in few minutes. We resolved SequestOx Tmax issue [indiscernible] last January. We continue to upgrade Elite’s facilities and continue to qualify low cost raw material suppliers; that takes a lot of time and efforts and money. And we completed successfully FDA inspection with no 483s; that’s three in a row with no observations from FDA. So, let me start with the approvals. We had four approvals in 2018 at the average one per quarter, which was our target from the year before. The first was Methadone. We received the approval in August of 2018. We secured quota and purchased the API, scaled up the product and launched Methadone in November of 2018 with our new sales and marketing partner Glenmark. That’s a very short period of time, and a very, very solid achievement. Amphetamine IR Adderall, this is a product that we developed with our copartner SunGen. We received approval in December, secured quota for the API and purchased the API. We are in the process of scaling up this product, and we selected a marketing partner for this product with whom we are now completing the licensing agreement and preparing to launch. Percocet, Oxy/APAP and Norco Hydro/APAP, we received approvals in July and November respectively. We currently are in discussions with the marketing and partner. However, due to the lawsuits initiated by the states and the problems that are associated with opioids, we are proceeding very carefully. We are not going rush into signing with someone and start selling, and then they add us to potentially the lawsuits that are happening between the states and the industry. We had four filings in 2018. Again, that's an average of one per quarter. One was for the extended release central nervous system product with our partner SunGen. This product has an IMS data of $1.6 billion. We expect approval in Q2, and launch shortly thereafter. We have already identified a sales and marketing partner, and we are in the process of finalizing the sales and marketing and distribution agreement. We filed an antibiotic tablet, the GDUFA date is Q4 of 2019. We filed it in December of 2018. Amphetamine IR, we filed it in February of 2018, we received the approval in December, IMS data is about $400 million. And I just explained our plan for launch date. That will be launched very soon, within couple of months. APAP with Codeine, GDUFA date is September of 2019, and I expect to launch that in Q4 of 2019.

Calendar Q4.

Yes. Everything I talk about is calendar. Beyond these filed products, we of course continue to develop other ANDAs as both with our partner SunGen and on our own. For competitive reasons, we will announce them only after successful clinical trials and/or filing. Next, I'll give you an update on SequestOx and the latest. SequestOx NDA, this is Elite's abuse deterrent IR oxycodone. As previously reported, our pilot results have demonstrated that the modified SequestOx formulation that we provided to FDA, addressed the FDA Tmax concern, and performed exactly like the reference listed drug. FDA confirmed that all we need is a bridging study now, which comprises of three studies, a fed, a fasted, and a dose proportionality study. But also, FDA we added couple of more requests. One is, additional characterization work for certain excipient and another is an assessment of risk of abuse via intervenous route. That is not something that they've ever discussed with us before or mentioned in the complete response letter and that was definitely a surprise when we heard about that. However, due to all the additional requirements, they did grant us another year-and-a-half extension for the PDUFA filing and the waiver of the $2.6 million that we paid for the filing fee, in order for us to finish all of this work. Elite has filed a patent covering the new SequestOx modification that resulted in the passing for the Tmax. And we also are evaluating right now the cost and timing of this project considering the new FDA request. Sales and marketing, our marketing partner Glenmark launched Methadone and Phendimetrazine in November. Two additional products Isradipine and Trimipramine are going to be launched also in transition to Glenmark and launched soon. We believe our alliance with Glenmark is an ideal place for these products. And their marketing strength will produce positive results for Elite. For the mixed Amphetamine product, we chose a new marketing partner that we believe was the best fit for SunGen and Elite. We actually interviewed several companies. They made bids on the product, all of them wanted it, and we selected one that was in definitely the best interest of SunGen and Elite. During our last investor call, I said that we plan to use SunGen to market this product. Our partner, SunGen decided recently not to move forward with marketing the product because they felt that somebody who is much bigger with a greater reach could do a better job. And therefore together, we interviewed, as I said, multiple partners, and selected one. Once the agreement is signed, we will release the name and let you know who are we working with. Till then, we will continue working on signing the agreement. We also have discussed -- the discussion is underway with other partners, other than two I just mentioned for the licensing of Dantrolene, Norco generic and Percocet generic. And again, once things are cemented and normalized in a contract, then we will update you on that. In summary, we had two ANDA approvals in Q4 of 2018, generic Norco and Adderall; we filed an ANDA in Q4 for antibiotics with our partner SunGen; we are waiting on approval for three ANDAs under review with FDA; we have two approved NDAs being site transferred, these are a remnants of the deal with the Epic; we have our abuse deterrent NDA SequestOx that is pending; we have improved our marketing bridge with our new sales partner, SunGen and the yet to be named new partner; we continue to upgrade our facility and qualify low-cost raw material suppliers because that is key to surviving in the generic world; and we have successfully completed and concluded three FDA inspections in a row with no observations. A - Nasrat Hakim: You submitted few questions to Dianne. So, I’ll try and take care of and answer as many of them as I can. And some of them have been grouped because they were abundant. So, the first one is on Methadone. When is the earliest we can expect to see revenues from the profit split for generic Methadone?

Yes. Well, that I addressed that in my thing. We're going to start seeing beginning of the profit split revenues in this March quarter, and they will increase in the subsequent quarters.

Okay. So, to be clear, what you're saying is, whenever we make the material and send it to them, they pay us the transfer price and then the others, once they sell, they share and that’s what takes some time?

Right. The manufacturing revenues, when we ship, we book them, and then when they sell according to the schedules and everything, we'll get the profit splits.

Excellent, okay. Amphetamine IR, when will the immediate release Adderall launch and when will SunGen -- or will SunGen be responsible for distribution? It will be launched, our best guess is within couple of months. And SunGen and us have decided to go with the third-party that we will update you on at the later date. Percocet and Norco, are you close to partnering the generic for Percocet and Norco. I just addressed that. We are working with people but we are moving slow and cautiously with these as I mentioned earlier. The state -- attorney generals of many states are filing lawsuits against all of the companies that make opioids. And we don’t want to be a part of that. So, we are being very careful on how to handle this. And we will keep you updated as soon as we find either a partner that uses a technique that does not get us in trouble or we will wait till the issue is concluded between the states and the pharmaceutical companies. SequestOx, what is the status of SequestOx? I just updated. That’s nothing new other than what I just mentioned. Epic Oxy IR, what is the status of Epic Oxy IR? That was developed under the strategic alliance agreement. This product was launched -- yes, three years ago and it’s been sold for over three four years -- three, four years. And we received royalties on that…

Royalties according to the strategic alliance agreement and they will continue investment…

Isradipine, results of Phase 3 trial of over 300 subjects on use of Isradipine to treat Parkinson's disease is supposed to be released early this calendar year? I believe it’s March, around the March timeframe. What impact on sales of Isradipine do you see if the drug is approved for Parkinson's? Of course, the FDA approval process would have to be followed. But, as I recall, Elite is one of only two to three who make Isradipine. Is that correct? Yes, that is correct. We are one of few companies that make Isradipine. We also have patients who have Parkinson’s calling Elite directly and asking for Isradipine. And we cannot do that. First, because we are not a pharmaceutical company -- we are not a pharmacy; we are a pharmaceutical company. We are not allowed to sell directly to the patients. And second, because this will be off label use. The impact, I don’t know what the impact is going to be because there are so many other factors that run into this. First, the results that our coming in March have to be favorable. They got to be clearly favorable that show that actually Isradipine makes an impact on Parkinson's patients. I don’t know what the answer is going to be or whether it is or it’s not. Okay? Second, the FDA needs to make decision if they need other trials from the sponsor or they are going to accept this and have them put the application together. And then, you have to file an application and then gets approval and then make the announcement that yes, Isradipine works on Parkinson’s. So, I'm watching this very closely but it’s going to be a while before we get to where everybody would like to see. And I do believe, I hope that’s going to be a very positive thing for Elite. And even if it wasn’t, I would like to see if [indiscernible] for Parkinson's patients. At the end of the day, that’s very critical for us. Series J, will there be a vote around April to increase outstanding shares that were started in the 4/28/2017 8-K due to Series J. It's not going to take a place in April but we are starting the process and we will update you on that. It will happen sometime this year.

Yes. The whole process it takes, there is a proxy in the shareholders meeting. So, there is a process of SEC filings and public announcements, the whole process will take roughly four months once it starts. So, we anticipate doing that during this year, which is the next fiscal year.

Sales and marketing, many companies manufacture products but have difficulty in tapping the marketing for those product. How does Elite plan to capitalize on the market for their products and drive increased revenue from those products? We know you can produce them, but how will you ensure an aggressive sales program? Well, obviously, we did that by not selling ourselves because we don’t have the sales force or experience and neither did the SunGen. We went with top notch companies, one is Glenmark and the second one is even bigger than Glenmark. So, that's how you do it. And last question, government shutdown. It was stated on the last conference call that the approval date and potential launch of the second co-develop product with SunGen, CNS, central nervous system extended release is expected in Q2 of 2019. Will the government shutdown delay the approval? If so, will they delay extended the same number of days of the shutdown? My best guess on that is this. For any of the procedures that you pay for, such as a filing, GDUFA fee was paid for that, the government will keep these due dates; they are not going to extend it. For anything that doesn’t have a GDUFA date, such as the prior approval supplement, these were put on the wait side. My guess is that this is not going to affect us. We are going to get the approval in Q2 and we’re going to launch in Q2. Again, that's my personal guess. The government could prove me wrong, at least from what we are hearing from FDA. That was the last question. This concludes this earnings call. Thank you, Myles. Thank you everyone for joining us today. And have a wonderful day.

Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect your phones at this time. Have a wonderful day.