Nasrat Hakim - President & Chief Executive Officer Carter Ward - Chief Financial Officer

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals’ Conference Call. At this time, all lines have been placed on a 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 limitation, Elite’s ability to obtain FDA approvals for the transfers of ANDAs or the timing of such approval process, 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 and the steps Elite may take as a result of the CRL, the results of an End of Review Meeting and what actions the FDA may 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, intellectual property protections and defenses, and the Elite’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 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. My name is Nasrat Hakim. I am Elite’s President and CEO. This morning, Carter Ward, our Chief Financial Officer will give us a summary of our great financials, after which I’ll come back with an update and final comments. Mr. Ward, the floor is yours.

Thank you, Nasrat and thanks as always everyone calling in today. On Tuesday, we filed our 10-K for the quarter ended June 30th, 2016. We’re in a March 31 fiscal year, so that means that the June quarter is the first quarter of our 2017 fiscal year. The 10-K is available on our investors section on our website, which is elitepharma.com; where else you may get your SEC filings from, it will be available there as well. So, if you haven’t seen our Q yet, please do get a copy from one of those sites. In short, our financials can be summarized as follows: Outstanding performance, strong financial position and 2 subsequent events that have been getting most of the attention. The subsequent events are obviously SequestOx and the Generic Percocet ANDA filing which we did 2 days ago. We’ve gotten a lot of emails, comments and questions on them and Nasrat will go over those in depth. We always say product development is obviously a key part of our business, but I would like to spend a few minutes going over the other key part of our business that doesn’t seem to get much attention and that’s the generic operations which by the way are the main driver of the strong financials included in our Q. So they should get more attention than they usually get. Our last earnings call was less than 2 months and if my memory serves me correctly, I think I referred to our commercial generics, something that has quietly grown into a solid business, and this quarter is a textbook example of that. Total revenues were up by more than 50% on a year-on-year basis. 3.3 million for this year’s quarter as compared to 2.2 million for the June 2015 quarter. 3.3 million in total revenues includes 2.6 million in manufacturing fees. You can compare that to the manufacturing fees of 1.7 million for the June 2015 quarter and that was a good quarter back then and the March 2016 quarter just 3 months ago, manufacturing revenues were 2.2 million and that was a very good quarter. So it went from 2.2 to 2.6 million from the March to the June quarter. So on a percentage basis, manufacturing revenues are up more than 50% on a year-on-year basis and 19% when compared to the immediately preceding quarter. So that is significant, that is steady and that is sustained growth. Utilization percentage of our factory continues to climb, we’ve also hired a few more employees in the factory and in our QC lab to keep up with these growing volumes. So Elite’s growth isn’t only felt by the company and reflected in our financial statements, but there are many families that also have been positively affected by this as well and it’s always nice to see that. Moving down the P&L statement, the notable expenses as it always is research and development. R&D cost were 1.6 million for this year’s quarter as compared to 2.4 million for the June 2015 quarter. That’s a decrease, but the decrease is really just due to the timing and the nature of the product of melamin activities compared to this year and last year. Last year we were running the trials for SequestOx which is a branded product and this year the R&D spend was mostly related to the Generic Percocet product, a much different cost profile when you’re talking about product development. And we did file the ANDA, just a few weeks after June 30th, so a couple of days ago as a matter of fact. So a tangible result was achieved pretty quickly. But the real takeaway can be seen when comparing the full R&D cost in the overall operating profit and in our case operating loss. For the June 2016, we had an overall operating loss of $1.2 million, but that amounted less than the 1.6 million we spent on R&D for the same quarter. So, this shows that our generic operations, they are not just covering the cost, they are not just covering our overheads, but they are also subsidizing product development activities. This is a second consecutive quarter that we have achieved this and once again this is clear evidence of the significance of our generic operations and the importance of its contribution. People that have been following us for a lot of years know that having a profitable, generic operations has always been a key plan in our strategic plan and we are performing as we have planned. Moving over to the cash flow statement, we had a net cash burn from operations of little less than $800,000 but that includes almost $450,000 in inventory buildup. Our volumes are growing, we have to buy more materials, we have greater inventories, so this is just a normal buildup to support the growing manufacturing volumes. So the operating burn was really not material. Looking further down the cash flow statement, it also shows that we invested another $300,000 in facility and equipment during the quarter. These are investments in our facility expansion that will enable us to support our growing volumes and business. It’s important to be proactive in this area and we are. Not enough to forecast increased volumes, we also need to ensure that sufficient resources are in place to service these volumes. When it comes to pharmaceutical manufacturing, that takes some time. So we have to invest and we have to build now, so that the resources and the facilities will be in place and validated when we need them. So the cash flow statement is a good place to see what’s being spent in these areas and take a look and you see we invested $300,000 in this area during the June 2016 quarter. Lastly, there is the balance sheet. Once again Elite has the strongest balance sheet it has seen. Cash was 12.8 million at June 30th, that’s up $1.3 million from the beginning of the quarter. Working capital was 13.6 million at June 30th and you can compare that to 12.1 million at the beginning of the quarter. So working capital increased nicely as well. All of this adds up to a strong balance sheet and a strong financial position, the strongest Elite has seen. So overall to sum it up, our financials show outstanding operating results, our cash flow is under control, our R&D and facility investment continue as planned. We filed an ANDA just a couple of days ago, and we have a strong financial position which provides the resources and the resiliency to resolve the issue raised by the FDA in regards to SequestOx. Well now our President and CEO Mr. Nasrat Hakim would like to give an update.

Thank you Carter. Our business continues to grow year-after-year. Our ultimate goal is to have a strong enough fundamental to go to NASDAQ with as much organic growth as possible. I have four points to update you on. First the generic product. Our generic products continue to grow and do very well. It takes a long time to create and compile an application. We have been working very hard to create a solid generic base for Elite. The 6 applications that we’ve targeted were created over a couple of years. This was done while we were concurrently working on SequestOx. It is our projection that on the average we’ll file an application every quarter starting with his one, Q3 of 2016. I will say this about the products unlike what Elite has historically had the IMS data for the majority of this product is in the 100s of millions of dollars. I was hoping to marry this with SequestOx once we get approval for SequestOx and launch or file all of those generics, that will take us to the next level where we will be ready for NASDAQ, a little delay that is not going to hurt us. The plan is simply to go to NASDAQ with as much organic growth in minimal stock split. This remains our plan. Second, SequestOx filing. I’ll update you first on the Oxy-APAP filing then we’ll go to SequestOx. The Oxy-APAP filing in that took place this week was one of the 6 applications that we discussed. This product is a strategic product, a widely used opioid, $700 million in revenue and there are 11 generic players. For Elite, a 2% market would more than double our current revenues, that’s how important this product for us and as I said we intend to target 5 more, 6 total. Oxy-APAP is not challenged by the ADS product. APAP is an early start to the nasal passages as per the FDA. We started working on ELI-202 which was Oxy-APAP with Nalrexone and even ran a clinical trial accordingly and when we start talking to the FDA and they issued their guidance stating that the APAP is considered to be anti-abused and we will not get favorable labeling, we reverted back to filings it without it, a lot cheaper pathway and it gets us to where we want to go. Doctor used a range of opioids depending on the patient and the type obtained. So this offers another alternative of the Oxy-IRs and SequestOx and other IR products. Again this is an ANVA NDA and no full effect as concerned with this product. Third, SequestOx. Adjacently the requirements are underway. On July 18, I updated you on the FDAs response, that was only 3 weeks ago. In the past three weeks we ran a multitude of invitro experimentation that stimulated different ole, fatty, acidic, stomach and intestines. We have 3 proposals for the FDA to evaluate that would reduce or eliminate the Tmax delay. We can demonstrate this, we are at DE, but first we need FDA’s feedback and blessing. We met Camargo and other consultants and are in process of preparing a package for the FDA shortly requesting a type A meeting. The process is a little complicated and it takes time. You first have to send a letter to the FDA requesting a meeting, once they grant a meeting and give you a date, you need to send them a package with all the testing and evidence that you need to present so they can review it before the meeting. Then we complete the work based on the FDA feedback’s and then we submit the new data and meet with them again to make sure that we delivered on the clinical trial that we said we’re to deliver on and they were successful. That’s when the whole thing gets concluded, at least this is the path forward. I should have more details for you by the next conference call. One of the questions was always regarding the licensing of SequestOx, to date the SequestOx licensing remains with Epic. Nothing have changed, Epic and PuraCap are still in discussions with us on this product. Okay, in addition to the fixed ANDAs, we continue to apply our ADF technology to products of interest. Finally, the stock price, obviously the drop in the stock price is a reflection of the delay in SequestOx. That is a personal decision, people invest as per how they feel the future of the company is going to be and the stock went down because the FDA approved SequestOx in a timely manner. The pipeline work is not affected. The fixed ANDA that I talked about now 5 has been filed will continue with minimal to no money from linking part. We continue to update our facilities and staffing and strengthen and grow the company. We continue to strengthen the generic business and grow it and we continue to have the same strategy to get us to NASDAQ. And we’ll definitely continue our talk with FDA to resolve whatever issues they have regarding SequestOx. As I stated before, Elite today is in the best financial shape in her history. We are going through some growing pains but Elite has the best talent and best pipeline ever. We continue to grow the generic business and the ADT business and we will file an application every quarter starting with the Oxy-APAP filing that just took place going through 2017. My goal is to file a minimum of 6 applications by the end of next year other than the NDAs for ADF if any. Finally, I appreciate the letters of support from doctors, healthcare professional and business owners. We will keep you updated as to the FDA’s response during our next meeting. Thank you for joining us and have a wonderful day. Thank you. Paul.

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