Nasrat Hakim - President, Chief Executive Officer and Director Carter Ward - Chief Financial Officer

Craig Moss - Morgan Stanley

Good morning, ladies and gentlemen, and welcome to Elite Pharmaceuticals Conference Call. At this time, all lines have been placed on listen-only mode and we will open the floor for your questions and comments following the presentation. [Operator Instructions] Before management begins speaking the company has the following statement. The conference 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. Participants are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, its ability to obtain FDA approval of the transfers of the ANDAs or the timing 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 those forward-looking statements. These risks and other factors, including, without limitation, the company’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, 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. 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, Antony. Good morning, ladies and gentlemen. My name is Nasrat Hakim. I’m Elite’s President and CEO. Carter Ward will give a summary of our financial, after which I will come back and take Q&A and make a final statement. Mr. Ward, you have the floor.

Thank you, Nasrat. Good morning, everybody, and thanks for calling in today. Yesterday, we filed our 10-Q for the quarter ended June 30, 2015. We’re on a March 31 fiscal year, so the June quarter is the first quarter of our 2016 fiscal year. The 10-Q is available on our website, elitepharma.com, as well as the usual site such as sec.gov, otcmarkets.com, Google Finance, Yahoo Finance. If you haven’t seen our 10-Q yet, you can get your copy from one of those sites and as always I recommend elitepharma.com. Now, let’s look at some of the key areas of our financials, specifically, the three numbers that I’m mostly concerned with that would be revenues, operating profit and operating cash flows. Revenues were $7.1 million for the quarter. We had an operating profit of $2.5 million and we had positive cash flows of $1.9 million for the quarter. All are outstanding and record setting numbers. Let’s start with the revenues. Revenues for the quarter as I said was $7.1 million, easily – this is easily the highest quarterly revenue in Elite’s history as well as being more than [audio gap] revenue mark for annual revenues and this year we are already above $7 million after just three months. Included in the $7.1 million, there is a $5 million milestone. That’s obviously a major component in our revenues and while milestones by definition are nonrecurring. Please remember that this is just the first part of the total $15 million in milestones related to the ELI-200 product development and licensing agreement with Epic. So there is $10 million more in milestones to be earned as ELI-200 is filed and commercialized. But the milestones aren’t everything, once ELI-200 is commercialized, there will be royalties and profit splits based on net sales and those will be accruing what we expect will be significant revenues on an ongoing basis. We expect that the $15 million in milestones will eventually become a minor component of the revenue stream to be generated by ELI-200. Those that remember on our last call in June, during that call I commented that ELI-200 licensing with Epic will have a significant positive effect on our financial statement and this quarter is certainly an example of that. But the record revenues are not solely due to the ELI-200 licensing. Our current generic product lines also generated $2.1 million in revenues for the quarter. That by itself represents record revenues for our quarter. I would also add that the Mark quarter, one just before this one was the first time we broke $2 million in a quarter and we did even better in this quarter. So the growth is continued and it’s sustained. Remember, our strategy is to expand and grow our generic revenue stream to create a stable business platform and from that to support the development of our Abuse-Deterrent technology. Our income statement clearly demonstrates that we are executing that strategy, that it’s working and value is being created. Generic revenues are up all across product line. The products licensed to TAGI Pharma continue to grow both in volumes and profits. Contract manufacturing revenues are up double-digit. We are starting to get contribution from Isradipine and Hydroxyzine licensed to Epic and launched earlier this year. And with regards to Epic there is several more products in that Epic license agreement that are closer to launch. That bodes well for the future. So while there is a lot of buzz over ELI-200 and the related current and future milestones and profit splits, don’t lose side over the steady growth in the generic side of our business. That sector has been setting revenue record almost every quarter. And with $2.1 million in revenues for this quarter, we just had another one. That’s really outstanding result. Now, a brief discussion of operating profits and cash flow. Our operating profits were $2.5 million for the quarter and we had a positive operating cash flow of $1.9 million for the quarter. I would also note that this is the first quarterly operating profit since December of 2010, almost five years ago and back then we reported a profit of $70,000, so barely any profit and this quarter it was $2.5 million. This profit is after paying almost $2.4 million in R&D cost and the positive cash flow is after these costs plus $2.1 million in payables. So product development is continuing at significant levels, liabilities are decreasing and cash flow is a positive of almost $2 million. All of these are very positive metrics in our financials. Clearly, our financials continues to strengthen. So to sum things up, when evaluating our financial, I think the biggest takeaway is that we are clearly demonstrating that Elite has moved beyond those old days of just for surviving and we are now financial stable, we are operationally sound, our facilities have been expanded and upgraded and they are ready to support continued and significant growth. We are close to completing the development of our first Abuse-Deterrent product and we are well positioned with the critical mass of finance, facility and personal already in place to continue development of the remaining products and our pipeline. It was truly an outstanding quarter and I’m looking forward to speaking with all of you on our next earnings call. Now, our President and CEO, Nasrat Hakim, would like to give an update. Nasrat?

Thank you, Carter. And I understood questions from our stockholders and some of the questions that show up again and is summarized in a list and gave it to me. So, what I am going to do is try and answer the list of questions that have been submitted to Dianne and then we will open the floor for Q&A. Q - Unidentified Analyst: The first question was regarding the licensing deal with Epic, what are the milestone revenues to be earned. What are Epic’s resources and capabilities with regard to marketing this product, do they have any right for future ADP product. A - Nasrat Hakim: I covered that before in previous calls, we are very excited about our sales and marketing licensing agreement with Epic. It is a very good deal for Elite and for Epic, it is a win-win. The terms as previously disclosed and discussed are $15 million in non-refundable milestone, plus a premium over the manufacturing cost, plus a royalty based on net sales. You see in this quarter finances that we have already received the $5 million that Carter just mentioned. The remaining milestone payment of $10 million will be corresponding to the filing and approval. Epic and Elite are actively working on commercial plan for ELI-200 launch. Epic has a generic sales force and they are creating a sales force in order to market ELI-200. The license that Epic has is for ELI-200 only. It is specific for the sales and marketing of that product. Epic does not have any right of first of use or any rights to Elite ADP products or technology. This was an exclusive specific agreement for sales and marketing of our product that we will continue to manufacture. Q - Unidentified Analyst: Second question is please comment on Elite’s pipeline and technology. A - Nasrat Hakim: ELI 200 is our highest priority and primary focus. As I had discussed in previous call there is a substantial list of other products that we can apply our technology and know-how to. We are developing other used [indiscernible] product and making good progress. We are focused more on the formulation and the process development. We are less focused on the clinical work right now because our primary focus again is ELI-200 and when we are done with ELI-200 we will shift our focus to the new product. ELI-201 and 202 are examples where we [indiscernible] technical war on them. But ELI-200 again is our primary focus and once we are finished with that we will go back, circle back evaluate finances and see how many we can take on. For competitive reasons, I will only talk in general and I will not go for specifics in our pipeline. In addition to ELI-200 Elite does expect to make other Abuse-Deterrent product and file them in 2016 and we will address all of this once we file ELI-200. Our target for the submission of ELI-200 is the end of the year and we do expect a six month review form FDA and we are counting on a launch in 2016. Q - Unidentified Analyst: Please comment on the status of the generic product license to Epic, what is the status of the ANDA product filed by Epic more than three years ago for which Elite will receive a 15% profit split. A - Nasrat Hakim: We launched [indiscernible] over a year ago and the sales have been steady at 600,000 units or tablets per month. Elite and Epic launched [indiscernible] hydroxyzine in 2015. We see substantial revenue growth this quarter from the generics because of continued growth for our existing genetic line and the addition of those two new products. We also have more generic products in the pipeline that Epic is working on. We will make the announcement once we have approval from FDA. Regarding the generic that Epic developed with Elite that has been pending approval by FDA for over 3.5 years now, I can make no protection as to when the FDA is going to approve it, but FDA's record has been about 3.5 or so years before they approve a generic application. So, we are hoping and expecting that it should happen soon, but again we are on that [indiscernible] and I can make no comments on that. Q - Unidentified Analyst: Fourth question, please comment on Elite plans regarding promoting, promotion of the company and the stock and an update on plans for a NASDAQ uplifting. A - Nasrat Hakim: Very interesting question, we are looking at the timing of the next annual shareholder meeting, but we do not have a date that yet. And uplifting to NASDAQ is on my mind and I’m planning for that for 2016. There is a lot to plan and to execute before we get to that point. I do not intend to do that unless we have the fundamentals and those fundamentals are followed and the timing is correct. A reverse split may be required, but as I said we are not ready to make that decision yet. I take the opportunity to promote Elite every time I get a chance and as per the filing I will have a little more time to do that as well. I will be presenting a [indiscernible] component next month in September. Q - Unidentified Analyst: Last question, is I see Novel and GAVIS were sold for a lot of money. What shares of the company did Elite own and how much did Elite receive for it? A - Nasrat Hakim: Ladies and gentlemen Novel Labs and GAVIS Pharmaceuticals were sold to Lupin for $880 million or thereabout. Novel and GAVIS are affiliates. Elite used to own about 9.6% in Novel and after few years of distributing stock to employees and management and issuing warrant our share was diluted to 3.54%. An evaluation of Novel Labs was done by an independent accounting firm and value the company at $47 million. Elite – and this was in 2011. Elite has noble taxes and tax returns that support this assertion. Given Elite’s ownership percentage, in Novel our share of the company would total $1.66 million. In 2014, we reached an agreement with Veerappan and we settled for $5 million for our ownership. We have no ownership in GAVIS and never did. We are on a tight schedule and we will go ahead and take few questions. So, Anthony if you could please open the floor for Q&A. Thank you.

Thank you ladies and gentlemen. [Operator Instructions] Our first question is from Craig Moss from Morgan Stanley, your line is now live.

Good morning Nasrat.

Good morning Craig.

First of all again thank you very much for all the hard work by you and your team there. It is much appreciated and thanks and terrific. You have covered a lot in this call, you’ve already answered a lot of questions, but I was just curious about the products that come after Elite 200, does Epic have a right off first [indiscernible] or can Elite go and make deals with whoever they want on subsequent product.

Thank you Craig. Actually they don’t. The reason we picked Epic is because they were really the most honourable, the contract was straight-forward as I said before. We actually rode the contract. They’ve been wonderful. They unlike other companies did not ask for the right of first of few results, they did not ask for ownership and technology, they did not ask for anything, accept the privilege of selling our product for the three things that I mentioned. We still make it here and they pay us all the cost plus premium. They pay us $15 million in royalties and we get a profit split. So, all of it was really great for us.

Thank you very much again and look forward to 2016, it could be a very big year. Thanks.

Thank you Craig.

Thank you all the team.

Thank you.

Thank you Craig.

Our next question is from O'Brien Schneider [ph], your line is now live. Q – Unidentified Analyst: Great, thanks so much. Another great quarter, you guys love the trajectory the company is on. Actually you can ask the same question about the 201, 202 in the potential Epic partnership, let’s ask this one instead. So, a lot of the payments that Elite has been receiving have been lumpy one-off type payment and that’s all great with milestones expected in the future. You guys have also been ramping up your staffing, you guys have really taken on some in the production side as well as on the research side. So, I was just wondering how you are guys are reconciling going forward with lumpy revenue streams vis-à-vis what are you cost outlooks look like and how you are managing that as far as expectations of revenue coming in forward as well as what your cost reps look like.

That is a great question for Carter, I would like to ...

I mean, as far as the lumpy revenue stream, first of all there hasn’t been, today there hasn’t been too many milestones we have finally got the big one just this quarter there has been some smaller ones in the past, but nothing on this magnitude and there are 10 million more to go. I just tell you that $15 million in milestones is being put in separate accounts and is being used solely to fund the development of the products to follow-on ELI-200. So that 5 million is kind of having a different internal accounting. So, what we are looking at as far as personal and resources and our activities is we have, we know what we need to develop these future products. The ELI-200 is pretty much done from a finance standpoint and from a Clinical Trial standpoint, we are in the last phases of that. The finance of that has been provided for out of our Lincoln Park facility and our operational cash prior to the 15 million and this 15 million is dedicated for the future products. And that will require different additional resources, more people, more lab equipment some upgrades to our facility. All of that will be funded through that.

Okay. Next question please. Hello.

Our next question is from [indiscernible], you line is now live. Q – Unidentified Analyst: This [indiscernible] in Belgium. Great quarter, great evolution of the company and congratulations on that. Most of my questions have been ...

Hello.

I think we last. Our next question is from [indiscernible] your line is now live. Q – Unidentified Analyst: I’ve been an investor in Elite Pharmaceuticals for many years, I sit and I listen to the conference calls, I usually really don’t say anything, I more listen than comment, but I did want Nasrat to make some comment that I would really like all of the stockholders to think about because there are some stockholders out there who want this company to move along at a much faster pace than it possibly can. So if you bear with me one minute, I would like to point out certain things. First of all, again, I want to congratulate you for a great quarter but more importantly I’d like to point out to all investors that the future of Elite can’t be any brighter. You have assembled a team of highly qualified people that will help to make this organization highly successful and profitable. We are near the completion of getting ELI-200 approved by the FDA, also there are many more products coming down the road. I’ve been an investor with Elite for many years and those of you who will have a little patience I believe you will be well rewarded. I believe in the company and I am willing to wait for it to tail off. This company before Nasart came on as CEO was a company really that was in deep trouble. You’ve turned this company well, I truly feel that over the next several years this company will be very profitable, very strong and for those of you who have patience will be very well rewarded.

Thank you. I really appreciate your positive feedback. Five years ago or so, Elite went through a lot of hardship and the management team and Epic really build the company out and got it on the right path and I really appreciate that. We scarified about 40% of the company or so for $3.7 million for the company to survive. So Epic, at that time owned roughly that, now they don’t own anything, all of it has been divested. Over the past few years, things have evolved so much that today Epic, same companies are bought about $3.7 million saved us $15 million for the privilege of selling one of our product with very generous condition. So thank you very much, we really feel it internally, the excitement is there but you’re right we started to grow, I have to help the company by loaning the money and today, we are financially sound and we are getting on. So Jerry, actually Jerry loaned the company $600,000 to give us a float, and today we are solid financially and most importantly, we have the creditability and that’s why we are being approached by a lot of companies from the outside. So it’s been rough to take off but it’s going to be a lot smoother in the future and over the next year or two. And two years are nothing in the pharmaceutical company’s life. We just talked earlier about Epic. They filed ANDA with the FDA three and a half years ago, and they haven’t gotten approval yet. We are fighting for an NDA and we are planning on launching in 2016. So thank you very much for saying that. I really appreciate it and so does the staff here.

Congratulations again.

Thank you.

Our next question is coming from Jay Dana [ph]. Your line is now live.

Thank you. Good morning. Nasrat, as you look out to your launch next year, what is your most recent intelligent on how to market, is it prime to accept the pharmacological abuse- deterrent approach versus the physical, anything fresh or new from your perspective on that? How quickly some market carries to adopt that and if you have any commentary relative to the Pfizer situation and also the recent pulling of an FDA filing by [indiscernible], if that was viewed as positive, negative or in different to Elite?

Excellent question and very, very, very intelligent question actually. It is an important thing why that [indiscernible] pull out on the last minute from having a meeting with FDA and used the physical approach. So to me till we hear from them again, it does not seem that the physical approach have made that much of an impact in the industry, that’s my personal analysis. Otherwise if you follow a data that is being effective, then we will be happy to present it and is all over the place. The pharmacological approach is the preferred approach and that’s why even police and emergency teams start carrying these [indiscernible]. So definitely it seems to be the preferred route. Pfizer is getting in the game and they are also similar to us using the pharmacological approach which is going to support us tremendously. They are relaunching Embeda and probably this fall they will an approval for an OXYBID using an ultrasound technology similar to us. Having Pfizer on us little Elite and with Pfizer on the same size of the pharmacological approach and paving the way for us is something that very exciting to me and I’m looking forward to it.

Given your history at Alpharma and your knowledge Pfizer technology, would you view that as similar to what you now have to offer, difference on what actually you performed, do you think when you get into the market you can offer doctors some sort of reason why should script yours instead of theirs even though they are both pharmacological.

Very good point. I don’t want to be arrogant enough to say I can take Pfizer on even if we are better than them they still kick my behind. So I will humbly say if they take the path for us and the industry and convince the doctors that the pharmacological approach is the preferred one, we will ride on their path and be able to capture enough market to make Elite look great. So it’s my good view of balance. If Pfizer is to earn $1 billion, that will barely move thus far. If we are to earn 20% of that, we will be in heaven. So I am not looking to take on Pfizer, I’m just looking to make sure that they do most of the work for me, educate the doctors, educate the pharmacists, educate the government and go ahead, and just sneak in with them.

One last topic, you discussed the concept of getting re-listed on NASDAQ and possibility of a reverse split which is obviously some that I don’t know that is overly appealing. But if you were to get to a revenue level that was good enough with the existing share count to get to an EPS level that at a reasonable multiple, you can get over $1, that would imply that the revenue necessary for ELI-200 will be fairly substantial. You just throughout the possibility the $200 million there and your response to the last question. I guess what I am trying to really figure out is, how big – what percentage of the market do you think will be pharmacological couple of years out and what kind of share can you get there because I’m trying to gauge this $50 million a year a product for company to $300 million a year product. Just trying to get my head wrapped around the market potential and the revenue for Elite once this is fully commercialized within the market.

It’s really hard for me to answer that. Pfizer is a company that educated the whole world about presence. Ten years ago, 15 years ago or so, nobody knew that if you have high cholesterol, you can take Lipitor. They educated everybody in the country and now just about everybody including people in the old days have specification. So when Pfizer is finished educating the market on the anti-abuse especially the pharmacological sector, I don’t know how big the market is going to be. Today, the opioid market is about $7 billion to $10 billion. We are a very small company. As I said, a small section of that will make a huge impact on us.

I honestly don’t have numbers for you but I know that for example the OXYBID is about roughly 3 billion. I expect that it’s going to be bigger than that when Pfizer enters the game. And if we get a small section of that, then we’ll still be in a good shape. As far as what you mentioned regarding the stock price, I’m with you there, I hate the reversal split and I do believe in the fundamental before you get on NASDAQ but anywhere else. But if we do not do it in a timely manner, I don’t want to hang around the bulletin boards for the next three, four years. We will do something to get us there.

To make us so much money and it’s viable and there may be a buyback program maybe viable. So far I am not seeing it still we start getting product into the market.

One last quick one, if you are identical to Pfizer, obviously it’s going to be hard to get your share once they’re established in the market. So is it a situation where you’re targeting the pharmacological views in turn with a different dosage or different type of time release, some sort of differential so that it’s not an exact look like.

Well, it depends. Pfizer is actually so far two categories. They have EMBEDA which is morphine sulfate and they have OXYBID. At the spectrum if you would think with me here and I’ve presented this before, the spectrum of drug think that it will possibly could be an [indiscernible] so you have three different categories and you have oxycodone, ultracodone, oxymorphone, hydromorphone and morphine sulfate. There is the potential of these different drugs and combinations that are when you throw a couple of other things. We don’t have to be with Pfizer competing with them every single product, but for something like OXYBID when the market is several billion dollars, I will take on anybody for that.

With some sort of differentiation or it look alike.

Even if it look alike, we should show a differentiation. But even if we are like-by-like and they end up getting 80% and we are getting 20%, that’s [indiscernible].

Got it. Thank you very much sir.

Thank you.

We have time for one last question and that is coming from [indiscernible]. Your line is now live.

Hope it doesn’t fall out again. Hi, this is [indiscernible]. Great quarter, sorry about the line being cut. I think most questions of me have been answered, but perhaps can you sketch a little bit abuse the terms product phase and where does your lead position itself into this space?

Excellent. First, thank you very much for calling. You are the longest distance caller we have ever had from Belgium. I have had people called from Iceland that are stockholders to enquire about the company and I have had people called me from China, but that was at [indiscernible]. You’re the first ever caller, so thank you. This space for us is really all inclusive. Our technology is excellent. It’s almost a cut and paste technology. The system is a wonderful way to make almost any opioid. So I do see us in every single opioid that is out there. As I just mentioned a minute ago, I see us in oxycodone, hydrocodone, oxymorphone, hydromorphone and morphine sulfate making every single possible combination thereof. The total market is about $7 billion to $10 billion and we definitely are going to throw our head in the ring for each and every one of these. Now, I’m not seeing and I don’t want anybody to misunderstand me and start asking me for clinical trials for all of these products because it takes a lot of money to run such a huge operation. So we’re going to take it a little time, we’re going to be creative in raising money, we’re going to be creative in trying to generate as much revenues as we can and everything we get, we will spend enough to certify and dedicate the rest of clinical trial.

Okay. Thank you and keep up the good work and good luck next year.

Thank you very much. We appreciate your call. Thank you, ladies and gentlemen. This will conclude this wonderful conference call today and looking forward to talking to you soon.

Thank you, ladies and gentlemen. This concludes today’s teleconference. You may disconnect your lines at this time. Have a wonderful day. Thank you for your participation.