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Elite Pharmaceuticals' (ELTP) CEO Nasrat Hakim on Q1FY2015 Results - Earnings Call Transcript
Aug. 18, 2014 5:12 PM ET |Pharmaceuticals, Inc. (ELTP)
Executives
Nasrat Hakim – President and Chief Executive Officer
Carter J. Ward – Chief Financial Officer
Doug Plassche – Executive Vice President-Operations
Elite Pharmaceuticals, Inc. (OTCQB:ELTP) Q1FY2015 Earnings Conference Call August 18, 2014 11:00 AM ET
Operator
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 and we will open the floor for your questions and comments following the main presentation. (Operator Instructions)
Before management begins speaking, the Company has the following statement. This 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 press release, readers 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 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 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 and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company’s ability to operate as a going concern, are discussed in Elite’s filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.
With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Financial Officer of Elite Pharmaceuticals. Sir, the floor is yours.
Nasrat Hakim
Thank you, Mandy. Good morning, ladies and gentlemen, and thank you for calling in today. My name is Nasrat Hakim and I am Elite’s President and CEO.
We’ll start with the financial report from our Chief Financial Officer, Carter Ward, followed by a brief update from our EVP of Operations, Doug Plassche. Then I’ll say a few words in the end and we will conclude with the Q&A.
Mr. Ward, you have the floor.
Carter J. Ward
Thank you, Nasrat, and thanks everyone for calling in today. Last Friday, we filed our 10-Q for the quarter ended June 30, 2014. We’re on a March fiscal year. So the June quarter is the first quarter of our 2015 fiscal year.
Nasrat commented last week that we had a strong start to our fiscal year and I think that pretty well summarizes the overall financial results and position for our first quarter of fiscal 2015.
Financials are available online at elitepharma.com, as well as sec.gov and all the usual other sites like Google, Yahoo!, MSN Money and OTC Markets. You had the weekend, so hopefully most of you have had a chance to review our financials.
I’d like to spend a few minutes going over some of the more important aspects of our financials. So when going through our financials, I’m going to start first with something that is not our balance sheet anymore and that would be the $3.3 million asset relating to our investment in Novel Laboratories. This investment is dating back to 2006.
During this quarter we sold our minority stake in Novel for $5 million and we recognized $1.6 million gain. $5 million in proceeds received was used to get us current on our bonds, which I’ll discuss later and also to help fund the ongoing trials and development of our abuse-deterrent opioid products.
The takeaway on the Novel transaction is that for the last seven plus years we had an asset that wasn’t contributing or supporting our core objectives and operations. During this quarter, we monetize that asset and we are now able to use those resources to support our corporate objectives. That’s a strong start to our fiscal year for sure.
Also no longer existing and relating to our balance sheet is the longstanding monetary defaults on our New Jersey Economic Development bonds. This monetary default reflects more than five years, and as of July 23 has been accrued. We’ve paid all principal and interest amounts which were in arrears, an amount of just less than $1 million.
We retired the Series B bonds, which carried 9% interest rate and we are now current on our Series A bonds. So we cheered a long standing monitory default, and solidified our balance sheet, we now have sufficient working capital on hand to fund the ongoing product development activities. Once again another example of a strong start to our year.
With that I’ll move on to the P&L statement. Revenues for the quarter were $1.2 million that’s a 60% increase on a year-on-year basis. Now the reason for this increase is pretty straight forward, all our products which are relatively new, ranging from less than a year to just over three years in the market. They’ve all grown as expected, the growth at this time was expected and the sales of our Phentermine, Hydromorphone, Methadone and Phendimetrazine are growing nicely. In addition, we launched Generic Naltrexone last September, so that product generate revenues during this year’s June quarter, but not in the June 2013 quarter.
So our commercial generic products are performing nicely. Let me also remind you there are twelve additional products which were acquired last year, which are being transferred for manufacturing either at Elite or at locations licensed by Elite. This in progress and this will provide an even greater and broader revenue base, which we expect will generate new and growing revenues. Yet again another example of a strong start to our year. We increasing revenues and we have a pipeline of additional products on the horizon for the future.
So moving down to P&L statement, into the operating expense section, by far, the most relevant number there is our research and development expense. Last year’s June quarter was the last full quarter before Nasrat Hakim joined us to Elite. From day one, Nasrat emphasized the urgency of commercializing the products using our abuse-deterrent technology. And this focus is clearly seen in R&D expense line items on our P&L statement.
R&D expenses for the June quarter of this year were just over $4 million, as compared to less than $600,000 last year. This is an increase of almost $3.5 million or more than 600%, that’s a big change from last year. Nasrat will talk about product development activities in more detail. And I just wanted to say that, as of today we’ve already conducted several successful studies, we have ongoing studies and trials for multiple abuse-deterrent opioid products, and we’re on schedule for filing of our first of these products by the end of 2014 itself. None of that existed last year. That’s why R&D expenses have increased.
From a finance perspective, we’re prepared and able to fund these costs. Our generic revenues are growing and they are contributing. We monetized our investment in Novel. We have the Lincoln Park equity line supporting us well. So, financing of the planned studies and the R&D activities is accordingly in place and available. I’ve also mentioned in the past the importance of putting working capital to use and this is exactly what I mean. We’re putting our working capital to very good use.
So to summarize, it has been certainly a strong start to our fiscal year. Revenues are up, product development continues to accelerate, we’re on track for our first opioid filing this year, and financially Elite has never been stronger. So there’s a lot to be encouraged about.
Now, our Executive Vice President, Mr. Douglas Plassche will give an operations update.
Doug Plassche
Good morning. It was just, I think, six weeks ago. So I will be fairly brief. On the commercial front, we have put a lot of our working systems and execution into good use, resulting in a slight reduction in headcount despite volume being up. We’ve eliminated approximately 15% of the commercial headcount. We continue to focus on upgrading equipments in both laboratory and manufacturing and continue to grow with each new product that arrives.
On the R&D front, we’ve been extremely active with the manufacturer of a number of submission batches. We hired additional technicians and technical service engineers to help with the processing of all the data to support the filings and we are starting to really see the benefit of those hires.
Capacity, we recognized will become a constraint, as we approach commercialization of the first ART product. To that end, we leased an additional 20,000 square feet in the current commercial manufacturing building and completely refurbished approximately 2,000 square feet of it for our QA Department to be centrally located.
The remainder of the space is open warehouse, which provides [ED] (ph) fast low cost internal construction for manufacturing. As a parallel activity, we are developing scope and bid documents for commercial scale manufacturing equipment, as well as evaluating existing commercial sites. To date these have been out of the stage. However, we will consider any site that suites our needs.
Overall, I think, we’re doing the right things on multiple fronts both tactically and strategically, and the quality and the cohesiveness of the team continues to improve resulting in much needed efficiency and momentum.
That’s all I have, Nasrat.
Nasrat Hakim
Thank you, Doug. Good morning again ladies and gentlemen. Over the weekend, I actually wrote a little presentation to go through with you, of all of our achievements in the past years since I have been the CEO. This morning I threw them to the trash, I decided not to do that. What I want to do this morning is walk you through our flagship product, ELI-200. And in precise again, many of the things that I’ve said to you before, because a lot of questions are coming to them that people have not understood the steps we have to go through to get this product to the market.
We have a lot of other products in clinical trial and lot of other activities. And I’m sure you’re going to ask about that when doing Q&A. So let me focus on ELI-200, because that is truly the most exiting right now. And I’ll walk you through beginning to end one more time what we’re doing. In order to launch a product, especially an anti-abuse product, NDA, you have to have a robust successful formulation. That requires a lot of work, reproducibility and long-term stability on accelerated temperature. We have that and that was very successful.
The second thing that requires bioequivalence trial, you got to compare your product to a comparator that the FDA knows often has tested before, have tested the product before. That was very successful and we’ve done that as well, that was the trials that we went through in January of 2014. After that, you have to comply with the FDA’s guidance on anti-abuse. That spells out the three categories for the industry to go through. You don’t have to comply with all of them. You have to comply with what you need to have on your labeling.
The first category is the lab in vitro anti-abuse. That is very exciting work, as a matter of fact, we created an entire department to handle this work at home, meaning at Elite. We hired a consultant with Ph.D. that’s managing the project, we hired a manager, scientist with an M.S. and many, many years of relevant experience in the industry, another scientist with masters in pharmacy and an M.S. will be finished in December and two summer interns, just to handle this kind of work. The late anti-abuse work is very intricate.
We were talking about trying to mimic what a person who wants to abuse your product to do at home. So you have on a lot of alcohol trials assuming people have alcohol at their house, acetone because it is used for nail polish all the way to juices and Coca-Cola. Very important work that has taken us at least seven month and we will be done with that in September and we will announce that works for you late September, early October and it will be ready for us deliver to the FDA.
The second two categories are the human abuse liability trials. Again, these are long-term extended trials from the time we started writing protocols till we will have data. It will probably take between seven and nine months. These are clinical trials where people will actually take our product.
When it’s intact and they take it when it’s crushed and they have to report back, the crushed felt like a placebo otherwise the experimental network. They cost millions of dollars and they are handled by a Canadian entity that had to have the approval of the Canadian Government as well as the FDA.
Again, the results hopefully will be done sometime toward the end of September, we’ll have a preliminary number. We will issue a final report somewhere around October. So the human in vitro studies and the in vitro studies will be ready before October. Why I am giving you these dates, because I am pushing this back on all the consultants to have them ready before we go to the FDA, pre-NDA meeting in October.
I need them to evaluate these and tell us if there is anything missing, so we can take care of it before the filing date of December 2014. The FDA asked for a pediatric study, which we have communicated to them that we’d like to do it sometime next year, was the application spending, and we have no doubt that they’ll accept, they’ll respect and that they will accept such a request.
In October, once we meet with the FDA, we’ll have them give us an assessment of the adequacy of all the data generated. Now we all interpret the regulations. We believe this is what we need to do, and then the FDA will tell you if you’ve gone to their standards or to their base or not. So we will have a lot of feedback hopefully after October from the FDA.
Again, my vision is and has been for the past year and I’ll update the view on this with every single meeting. And it was the full order of my stat to deliver a filing by December of this year, and we are on target to do that. The only thing that could delay us, as I said before, no one can stop us. Elite’s anti-abuse is coming to the market. The only entity that could delay it is if the FDA requested one more clinical trial, which will put us on lab out six months. We will know about that once we meet them in October.
Next step, what are we thinking about once we file. We believe the FDA will brand us, expedite the review and we’ll give us results probably by – or approval by September of 2015. That will be the date where we’d be launching and about a year from now, August, September of 2015. To do so we have to decide what we’re doing our product. I have made the decision we will be manufacturing ELI-200 ourselves.
I have had several companies that approached me and asked if contract manufacture for us, they have much bigger facilities and I’ve decided the product is staying with us. The marketing of the product, we have several options. We either contract the sales and marketing force, and Chris and I have been in contact with such entities and that proposals and numbers and what have you.
And the second is to have a well-established pharmaceutical company that has the capabilities and sales and marketing force of 150 to 200 people that can sell our product in addition to this at some kind of a profit sharing or commission. I have not made the decision on that part and that will have to be made by December once we file, okay.
This is the status of the ELI-200. It is the most exciting product we have right now. We are filing an application, which have never happened in the history of this company. We’re launching an awesome product. I mean this is exceptionally exciting.
We have several other products in development that we’ve updated to you on. We’ll start with the clinical trials for ELI-201, same thing with ELI-202. Again, the results and data will be available in October probably. We filed INDs for all of them. We’re in communication with FDA on what is required and all of that part is exciting, but the filing will take place in December of this year for ELI-200 and that really is our flagship.
I will not address any of the other issues there. Any time I give a presentation on what’s happening with the [IND] (ph) and all of this I get asked questions. So I’m going to arrange for you guys, but ask the questions on the rest of the issues.
And, operator, we can open now for question-and-answer.
Question-and-Answer Session
Operator
Thank you. Ladies and gentlemen, the floor is now open for questions. (Operator Instructions) Okay our first question is coming from Bob Parker. Please post your question.
Unidentified Analyst
Good morning gentlemen, congratulation again, on another great quarter. Question on what’s your expectations from the FDA when you’re filing these INDs for ELI-200 and ELI-202?
Nasrat Hakim
Good morning Bob.
Unidentified Analyst
Good morning.
Nasrat Hakim
The reason we file an IND, IND is investigational new drug application. What you do is, you get an exemption from the FDA to introduce a product that has not been approved yet into interstate commerce, okay. So whenever you make an ELI-200 and you’re going to sent it to a clinic where you are having a dosing to human beings, how do you do that when you don’t have an approval? So the IND is resistant that was created to overcome that. It also gives the FDA study base to think about whether the trial you are going to run, that’s is acceptable to them or detrimental to the human beings and will ask you to add more safety controls, okay.
Furthermore, it opens up the line of communication with FDA whereby, we would ask them a question like we did with the – in vitro with the latter studies. We said here is what we’re doing? They can bag with a very intelligent analysis saying here’s what we propose you do and that helped up to work actually that we’re going to do by quite a bit and helped us out tremendous. So that’s why you file an IND.
Unidentified Analyst
Okay. Can I follow-on with a quick one, this is in regards to the 10-Q on the expansion of your Northvale facility. Does this give the potential for ELTP to manufacture and distribute all the ART drugs without a partner?
Nasrat Hakim
Not all. If we are going to with the Hakim vision of more than a dozen, I’ll need a huge company for that. But if yes it does allow us to launch this product and probably two three others.
Operator
Thank you. Our next question is with [Steve Smith] (ph). Your line is live.
Unidentified Analyst
Gentlemen, I would like to thank you for another stronger quarter and all the hard work you’ve put it.
Carter J. Ward
Thank you, Steve.
Doug Plassche
Thanks Steve.
Unidentified Analyst
Given that Elite’s generic NDA ART line takes less time and money to bring to market then Elite’s once daily ELI-216 product can you speak to what the current plans are for this product say for instance to partner a combo ELI-201 and ELI-216 together and how quickly you are planning to move forward with this product as there is no once-daily abuse resistant product on the market to date?
Doug Plassche
Obviously that’s a very interesting question and I think about that a lot, to take products like this to market by ourselves would require a lot of money. Mr. Ward here thinks day and night on how he can get me another $50 million, but definitely all options are on the table and I have no issue and I have talked to other companies about partnering with us in order to cover the clinical trial cost.
At the end of the day my philosophy is very simple. I’m very open-minded. Whatever makes sense for Elite I will do it.
Unidentified Analyst
Okay. Just another quick question. Bob previously answered the other question I was interested in. But you had mentioned during the last conference call that there were two pharma companies that had contacted you and you didn’t realize that they were actually interested in Elite’s technology. Anything further going on with those two companies as far as talks and discussions?
Nasrat Hakim
The answer is nothing has changed for the past six weeks since we had meeting with you guys, and, yes, we have even held meetings.
Unidentified Analyst
Okay.
Nasrat Hakim
Correct. We are definitely actively pursuing that Steve.
Operator
Thank you. Our next question is from [Scott Dixon] (ph). Your line is live.
Unidentified Analyst
Good morning, gentlemen. Great job so far this quarter. Nasrat, my question is, I know you’re trying to earn for a three-year contract. Are you looking to stay on longer?
Nasrat Hakim
I’m not sure who started that rumor, but I’ve heard it before. So I went ahead and looked at my contract and it doesn’t say three years and we’re in it. So, I’m here as long as Elite needs me and as long as I’m having fun and bringing stockholder value. Since I’ve taken over a year ago the stock has increased by about 400%, 500%. We’re introducing new product to the market. As long as good stuff is happening I’m here.
If a huge company end up paying the right cash for Elite, I’m very open-minded. And they buy us tomorrow, I retire tomorrow. So definitely I could be here for the next five, 10 years and that could happen tomorrow, but I couldn’t be out sooner than three years.
Unidentified Analyst
I have one more quick question. The evaluation, you gave a three tire money value to the price. At what plane are we looking at the high end of that evaluation? What needs to happen to get there?
Doug Plassche
Well, that evaluation was based upon the products identified in our strategic plans that we are developing. And so, once those get commercialized and approved that’s probably when – that’s when the model indicates we should be approaching the high end. Now, keep in mind that valuation was really the current value of the future prospects. So when that was done last year around October, November timeframe, that was the current value assuming all of these products were to come online. So whatever the inflation rate is should be adjusted into the price in the future.
Operator
Thank you. Our next question (indiscernible). Your line is live.
Unidentified Analyst
Yes. Hello.
Carter J. Ward
Good morning.
Ashok Nigalye
Hi. Good morning.
Unidentified Analyst
Good morning. I had one question and then I’d like to follow-up with another one if there is time. In your 10-Q they mentioned something about some arbitration of Phentermine with precession dose. And I was just curious if that was going to have any impact on the supply and if there is going to be any potential fallout to that in terms of costs in that arbitration.
Doug Plassche
Okay, I don’t think it will, like any partners you have contract that says when you have disagreements you go to arbitration. We have filed to the arbitration, however, we have not gone to an arbitrator yet, our lawyers are discussing it among themselves. It has not affected the supply from us to (indiscernible) precession dosing or the pricing. And we hope to conclude and resolve issues over the coming few months.
Unidentified Analyst
Okay.
Carter J. Ward
And you see, during this whole period our revenues are increasing. So we continue to supply in sell to precision dose.
Unidentified Analyst
Okay. And that’s great lead in for the other question. In terms of the increased revenues on the 10-Q there was no mentioned operating cost excluding R&D typically you have that number, do have a number on the operating cost for the quarter minus research and development.
Carter J. Ward
Well yes, I mean if you look at the P&L statement, our operating expenses are categorized into four numbers, there’s the R&D there’s general and administrative expenses, non-cash compensation and depreciation. So they were all there, and I’ll just tell you that the G&A expense, general administrative were $626,000 I believe. Our total operating expenses were $4.8 million and now would – that’s also including the non-cash items, $4 million of that is R&D so most of it is in R&D, right.
Operator
Thank you. Our next is with [James Smith] (ph). Your line is live.
Unidentified Analyst
Good morning gentlemen, very good quarter. I appreciate everything.
Nasrat Hakim
Good morning, James.
Unidentified Analyst
I know people are thinking about this. So I’m going to ask and I don’t know how could even answer it, but can you tell me why the stock is just so flat but all it is positive news?
Nasrat Hakim
If I had the crystal ball I would. Honestly I can’t even begin to guess. Elite has had a turbulent history and that affected us a little and there aren’t a lot of negative news, some bashers here and there. But overall, if you step back and look at our achievement, especially in the last year it’s mind-boggling. And you can suppress things like this for a little while, but you cannot once there is a product that’s been submitted to FDA, you cannot – once the product that’s been approved by FDA, once hopefully we either come up with a partner or financing. So we continue with this. So the next few months are going to be really telling and I feel, this is my personal feeling, that this is going to change and over the next year, especially with an approval from FDA and a long stay of hopefully next September, nobody is going to be able to stop us.
Unidentified Analyst
I agree. Thank you very much.
Nasrat Hakim
Thanks, James.
Operator
Thank you. (Operator Instructions) Our next question is [Steve Carter] (ph). Your line is live.
Unidentified Analyst
Good morning, gentlemen. Congratulations on the quarter and thank you for the good work. And I have two quick questions and I will be quick and a follow-up from the previous person I was just on. I don’t think there was a big surprise why the price of the stock is suppressed. I think the vote for the new shares is one of the biggest reasons and I wanted to ask about that. I think there was a big concern among investors about the increased number of shares and I also wanted to ask what is happening with the possible uplifting at the stock.
Nasrat Hakim
Okay. The uplifting of the stock on the NASDAQ is one of the things that I don’t mind, and, again preliminary, I see us there in 2016. I have always said this from day one, I do believe in fundamentals. I need to see our company have solid fundamentals, earnings and revenues, which determines the price of the stock and I do not want to rush to any stock exchange and have us crash back into a penny stock. Okay. So it’s not going to happen until we file a product, get an approval and start generating revenue. I want us there for good period. And hopefully it will happen organically and the financials will support it.
As to the number of shares, and I’ve heard what you said from other callers and from few people. Maybe it is, but the fact is whenever you are a small company like us, which have an exceptional product and you don’t have money to take it all the way, you have to bring in some kind of a financing. The Lincoln Park deal has been one of the best things that this company has ever done.
Here is my analogy of why I think that is excellent. (indiscernible) on this beautiful house that’s sitting on a great mansion, but it doesn’t have a roof, and you know that if you do not invest the money in building the roof, rain is going to destroy it, okay. Bring in a 10th person who will take 10% of that in pi or pie, if you will, will be the best way for you to protect the house and have a roof on top of it and have an asset that’s valuable.
Elite was exactly like that. We had the technology that we could not take anyway, because we don’t have money and without the deal with Novel and without the deal with Lincoln Park, the company would not have increased 500% in share even though we added more share and the company would not be able to get an approval for the first half product. Yes, it is a traded, but I think it’s more than a fair one.
Unidentified Analyst
Very eloquent answer and I appreciate it. The other quick question is something that is confused me for a while. The site transfers for the generics, the CBE-30s0, and I’m tracking specifically about Isradipine. It seems like this was filed months ago and there’s been no news on what’s happening with those and I don’t understand it.
Doug Plassche
Okay. Actually it’s the [alarm] (ph). So let me walk you through it. I do believe I’ve covered this before. I apologize if you weren’t on the call or I did not emphasize them up. We made Isradipine at our facility in here at Northvale. We put it on stability. We created the CBE-30 and we filed it to the FDA. We had a strict feedback from center that they want us to – they said the CBE-30 is still open. We would like you to validate the process before you launch it. And they literally said to us, you can validate the process and launch and then notify us. So from their standpoint we can move forward.
The issues we encountered is the same issues that a lot public companies encounter. First, the API manufacturer was the only AP. We had single source API manufacturer in our application. So, in order for them to sell us product for us to go ahead and validate they requested first that we pay the PDUFA fee on their behalf. They were not using their DMF. So they wanted us to pay that. We paid it. It was like $36,000 or so.
Then they demanded that we buy all of the raw materials that go into making Isradipine. So we have to fork another chat for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot was API which is lot of API and a lot of negotiations took place between Doug Plassche and these people in order to finally to get us the API. Now that we have the API Doug needs a prioritize it and I anticipate that we will go ahead and finish that edition and launch in Q4 of this year.
There is a ton of work that’s been taking place, but it takes a while for us to be able to bring this all to conclusion and go ahead and validate and file the product or launch the product.
Operator
Thank you. (Operator Instructions) Our next question is with [Mark Barlich] (ph). Your line is live.
Unidentified Analyst
Good morning gentleman and congratulations on another great quarter and overall another great yield for Elite, good work done by the team there.
Carter J. Ward
Thank you Mark
Unidentified Analyst
Couple of questions, quick questions. You really emphasized ELI-200 and it seems obvious that you’re receiving FDA guidance on what needs to be done to get this product to market by end of the year. If it’s successful if all the tests are successful, which so far they are and everything goes as planned FDA receives it’s submission and ultimately grants the product to be produced, does that make the follow-up products that much easier as far as the processes, I mean, like ELI-201, ELI-202, can it be streamlined a little with modifications, relating specifically to that type of product? But does it make the testing process that much easier because it’s been already approved in ELI-200 and since the Elite’s test is modular, does the FDA give a more of the streamlined on the follow-up products?
Nasrat Hakim
Absolutely, okay, that is very true. It’s from the FDA standpoint than ours. A lot of this, I mean the guidance on the anti-abuse is recent so it was uncharted waters to a large extent. Once we have gone through it thoroughly with the FDA and ELI-200, then we can already anticipate what the FDA wants. For example, in vitro studies, or in the human anti-abuse studies, we can anticipate that and go ahead and be proactive and one all of these studies instead of submitting a petition to FDA and waiting to see if it’s okay. You are correct it will help a lot to expedite things in the future and possibly it could have a little bit of savings associated with it because we can bump a couple of things at the same time.
Unidentified Analyst
Excellent. And my second question, you really seem to be keying in on September, late September for some significant information. Are you coinciding this with your appearance at the Rodman Conference to have substantial presentation there with new products from Elite.
Nasrat Hakim
That really sound like it is, but it’s not. The Rodman Conference is early in the month, its eighth through tenth I believe. And the results that we are getting will be towards the end of the month and the final the reports will be in October. I am really trying to set everything to coincide with meeting with the FDA, because the more I can give them, the better guidance they can give me. The FDA are not requiring I bring anything to the pre-NDA meeting. But the more I bring them, the more feedback they’ll give me and that’s really my driving source.
Unidentified Analyst
Excellent. Thank you gentlemen again job well done.
Nasrat Hakim
Thank you Mark.
Carter J. Ward
Thank you Mark.
Operator
Thank you. Our last question for today [Sally Prasad] (ph) your line is live.
Unidentified Analyst
Hi Mr. Hakim and the rest, you’ve done a wonderful job and we’re really proud of all of your efforts. My comment is I’m sure you’ve heard of the 60 minute show where they showed hassle free trading by the big black computers, all that big banks are doing and governments staffs admitted what they do is, any stock, any stock that goes up 5% gets shorted by their computer immediately and then gets bought back and then shorted when it goes up again. This goes on all day long.
And this is something that some people are fighting it and trying to get another exchange in there already got one and the bookies have been written about it. But it’s a very deterrent thing to retail buyers, because they buy stock and then it goes down immediately. What they do is they take the cream off the coffee every time and it should be illegal and you should speak to your Congressperson and let them know be very aware of what you’re doing with the FDA and everything else, so that they will kind of keep an eye on it and kind of make sure you get fair treatment. Because let me tell you small companies many times get abused because they don’t make donations to Congressmen and all they don’t have any clout.
And one other thing I wanted to say is your stock increase in not unreasonable. The stock afloat here is a very comfortable number, and those companies that have three or four billion shares, now reputable small companies that are doing well, but not go to an exchange hence other stock is strong until the news is good is the greatest stat here because I have several that get reversed with, went to NASDAQ and got down to where they were way before the reserve split. It’s just not necessary right now for you to do that. I think you are very wise man and thank goodness you came to this company. And that’s all I want to say and thank you.
Doug Plassche
Thank you, Sally. Excellent. Thank you. Appreciate your help.
Carter J. Ward
Thank you, Sally. Good to hear from you.
Operator
We have no further questions at this time. I’d like to hand the floor back to management for closing statements.
Nasrat Hakim
Okay. Excellent work. Thank you all joining us today. This has been an extremely exciting yield for Elite. Thank you for your support and look for really good news, because excited about this company. The next few months are going to be sensational. And we’ll talk to you sometime in November.
Carter J. Ward
Thank you all.
Doug Plassche
Have a nice day.
Operator
Thank you. Ladies and gentlemen, this does conclude today’s conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
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JosephCortes
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Thanks .
Truth is ELTP presented a wonderful report.
A quick brief.
Consolidated revenues were $1.2 million for the quarter, an increase of approximately 61% over consolidated revenues for the comparable quarter of the prior year. The significant increase in revenues is due to the continued growth and expansion of Elite's generic product lines. In addition, Elite monetized its minority ownership interest in Novel Laboratories this quarter, receiving $5 million and recognizing a related gain of $1.7 million.
Development of our abuse-deterrent opioid technology continues to be Elite's top priority and we invested $4.0 million this quarter for a human abuse liability study, bioequivalence studies, and other product development activities. Elite remains on track to file its first abuse-deterrent opioid product, ELI-200, by the end of calendar 2014.
Elite's balance sheet continues to strengthen. Working capital surpluses increased from $3.8 million at the beginning of the quarter to $4.8 million as of June 30, 2014. Elite also retired the NJEDA Series B bonds and is now current with respect to all principal and interest payments due on the NJEDA Series A bonds.
Nasrat Hakim, CEO of Elite commented, "We had a solid start to our fiscal year. Our generic product lines are performing well and our pipeline of new generic products being transferred will provide further opportunities for growth. The development of our abuse-deterrent opioid products continues to progress at a rapid pace. We are on schedule to file our first product this year. In addition, Elite's balance sheet is stronger and we cured the monetary bond default, all of which provides stability for our future."
I need a little help here!!!
With such excellent news.... and today the stock goes down 8.24%.
Now, can anyone explain how is this even possible?
18 Aug, 05:31 PMReply! Report AbuseLike2
drjackho
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Explanation for Poor PPS Performance:
The last 8 weeks of poor PPS is a reflection on ELite's incompetently run PR program.
These folks Desperately need someone who knows how to develop a successful PR campaign.
18 Aug, 09:57 PMReply! Report AbuseLike0
Charles Stermetz
Comment (1)| + Follow | Send Message
There has been some manipulation for some time now... Not quite sure how people do it, but that's the only explanation.
18 Aug, 06:17 PMReply! Report AbuseLike1
terryd2518
Comments (26)| + Follow | Send Message
if you believe it's really just another opportunity to buy low ......I am
Copy and paste from you know where. Thanks Dr. Thorfin.
Dr_Thorfin Tuesday, 08/19/14 01:41:19 AM
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Post # of 122149
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Elite Pharmaceuticals' (ELTP) CEO Nasrat Hakim on Q1FY2015 Results - Earnings Call Transcript
Aug. 18, 2014 5:12 PM ET |Pharmaceuticals, Inc. (ELTP)
Executives
Nasrat Hakim – President and Chief Executive Officer
Carter J. Ward – Chief Financial Officer
Doug Plassche – Executive Vice President-Operations
Elite Pharmaceuticals, Inc. (OTCQB:ELTP) Q1FY2015 Earnings Conference Call August 18, 2014 11:00 AM ET
Operator
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 and we will open the floor for your questions and comments following the main presentation. (Operator Instructions)
Before management begins speaking, the Company has the following statement. This 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 press release, readers 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 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 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 and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company’s ability to operate as a going concern, are discussed in Elite’s filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.
With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Financial Officer of Elite Pharmaceuticals. Sir, the floor is yours.
Nasrat Hakim
Thank you, Mandy. Good morning, ladies and gentlemen, and thank you for calling in today. My name is Nasrat Hakim and I am Elite’s President and CEO.
We’ll start with the financial report from our Chief Financial Officer, Carter Ward, followed by a brief update from our EVP of Operations, Doug Plassche. Then I’ll say a few words in the end and we will conclude with the Q&A.
Mr. Ward, you have the floor.
Carter J. Ward
Thank you, Nasrat, and thanks everyone for calling in today. Last Friday, we filed our 10-Q for the quarter ended June 30, 2014. We’re on a March fiscal year. So the June quarter is the first quarter of our 2015 fiscal year.
Nasrat commented last week that we had a strong start to our fiscal year and I think that pretty well summarizes the overall financial results and position for our first quarter of fiscal 2015.
Financials are available online at elitepharma.com, as well as sec.gov and all the usual other sites like Google, Yahoo!, MSN Money and OTC Markets. You had the weekend, so hopefully most of you have had a chance to review our financials.
I’d like to spend a few minutes going over some of the more important aspects of our financials. So when going through our financials, I’m going to start first with something that is not our balance sheet anymore and that would be the $3.3 million asset relating to our investment in Novel Laboratories. This investment is dating back to 2006.
During this quarter we sold our minority stake in Novel for $5 million and we recognized $1.6 million gain. $5 million in proceeds received was used to get us current on our bonds, which I’ll discuss later and also to help fund the ongoing trials and development of our abuse-deterrent opioid products.
The takeaway on the Novel transaction is that for the last seven plus years we had an asset that wasn’t contributing or supporting our core objectives and operations. During this quarter, we monetize that asset and we are now able to use those resources to support our corporate objectives. That’s a strong start to our fiscal year for sure.
Also no longer existing and relating to our balance sheet is the longstanding monetary defaults on our New Jersey Economic Development bonds. This monetary default reflects more than five years, and as of July 23 has been accrued. We’ve paid all principal and interest amounts which were in arrears, an amount of just less than $1 million.
We retired the Series B bonds, which carried 9% interest rate and we are now current on our Series A bonds. So we cheered a long standing monitory default, and solidified our balance sheet, we now have sufficient working capital on hand to fund the ongoing product development activities. Once again another example of a strong start to our year.
With that I’ll move on to the P&L statement. Revenues for the quarter were $1.2 million that’s a 60% increase on a year-on-year basis. Now the reason for this increase is pretty straight forward, all our products which are relatively new, ranging from less than a year to just over three years in the market. They’ve all grown as expected, the growth at this time was expected and the sales of our Phentermine, Hydromorphone, Methadone and Phendimetrazine are growing nicely. In addition, we launched Generic Naltrexone last September, so that product generate revenues during this year’s June quarter, but not in the June 2013 quarter.
So our commercial generic products are performing nicely. Let me also remind you there are twelve additional products which were acquired last year, which are being transferred for manufacturing either at Elite or at locations licensed by Elite. This in progress and this will provide an even greater and broader revenue base, which we expect will generate new and growing revenues. Yet again another example of a strong start to our year. We increasing revenues and we have a pipeline of additional products on the horizon for the future.
So moving down to P&L statement, into the operating expense section, by far, the most relevant number there is our research and development expense. Last year’s June quarter was the last full quarter before Nasrat Hakim joined us to Elite. From day one, Nasrat emphasized the urgency of commercializing the products using our abuse-deterrent technology. And this focus is clearly seen in R&D expense line items on our P&L statement.
R&D expenses for the June quarter of this year were just over $4 million, as compared to less than $600,000 last year. This is an increase of almost $3.5 million or more than 600%, that’s a big change from last year. Nasrat will talk about product development activities in more detail. And I just wanted to say that, as of today we’ve already conducted several successful studies, we have ongoing studies and trials for multiple abuse-deterrent opioid products, and we’re on schedule for filing of our first of these products by the end of 2014 itself. None of that existed last year. That’s why R&D expenses have increased.
From a finance perspective, we’re prepared and able to fund these costs. Our generic revenues are growing and they are contributing. We monetized our investment in Novel. We have the Lincoln Park equity line supporting us well. So, financing of the planned studies and the R&D activities is accordingly in place and available. I’ve also mentioned in the past the importance of putting working capital to use and this is exactly what I mean. We’re putting our working capital to very good use.
So to summarize, it has been certainly a strong start to our fiscal year. Revenues are up, product development continues to accelerate, we’re on track for our first opioid filing this year, and financially Elite has never been stronger. So there’s a lot to be encouraged about.
Now, our Executive Vice President, Mr. Douglas Plassche will give an operations update.
Doug Plassche
Good morning. It was just, I think, six weeks ago. So I will be fairly brief. On the commercial front, we have put a lot of our working systems and execution into good use, resulting in a slight reduction in headcount despite volume being up. We’ve eliminated approximately 15% of the commercial headcount. We continue to focus on upgrading equipments in both laboratory and manufacturing and continue to grow with each new product that arrives.
On the R&D front, we’ve been extremely active with the manufacturer of a number of submission batches. We hired additional technicians and technical service engineers to help with the processing of all the data to support the filings and we are starting to really see the benefit of those hires.
Capacity, we recognized will become a constraint, as we approach commercialization of the first ART product. To that end, we leased an additional 20,000 square feet in the current commercial manufacturing building and completely refurbished approximately 2,000 square feet of it for our QA Department to be centrally located.
The remainder of the space is open warehouse, which provides [ED] (ph) fast low cost internal construction for manufacturing. As a parallel activity, we are developing scope and bid documents for commercial scale manufacturing equipment, as well as evaluating existing commercial sites. To date these have been out of the stage. However, we will consider any site that suites our needs.
Overall, I think, we’re doing the right things on multiple fronts both tactically and strategically, and the quality and the cohesiveness of the team continues to improve resulting in much needed efficiency and momentum.
That’s all I have, Nasrat.
Nasrat Hakim
Thank you, Doug. Good morning again ladies and gentlemen. Over the weekend, I actually wrote a little presentation to go through with you, of all of our achievements in the past years since I have been the CEO. This morning I threw them to the trash, I decided not to do that. What I want to do this morning is walk you through our flagship product, ELI-200. And in precise again, many of the things that I’ve said to you before, because a lot of questions are coming to them that people have not understood the steps we have to go through to get this product to the market.
We have a lot of other products in clinical trial and lot of other activities. And I’m sure you’re going to ask about that when doing Q&A. So let me focus on ELI-200, because that is truly the most exiting right now. And I’ll walk you through beginning to end one more time what we’re doing. In order to launch a product, especially an anti-abuse product, NDA, you have to have a robust successful formulation. That requires a lot of work, reproducibility and long-term stability on accelerated temperature. We have that and that was very successful.
The second thing that requires bioequivalence trial, you got to compare your product to a comparator that the FDA knows often has tested before, have tested the product before. That was very successful and we’ve done that as well, that was the trials that we went through in January of 2014. After that, you have to comply with the FDA’s guidance on anti-abuse. That spells out the three categories for the industry to go through. You don’t have to comply with all of them. You have to comply with what you need to have on your labeling.
The first category is the lab in vitro anti-abuse. That is very exciting work, as a matter of fact, we created an entire department to handle this work at home, meaning at Elite. We hired a consultant with Ph.D. that’s managing the project, we hired a manager, scientist with an M.S. and many, many years of relevant experience in the industry, another scientist with masters in pharmacy and an M.S. will be finished in December and two summer interns, just to handle this kind of work. The late anti-abuse work is very intricate.
We were talking about trying to mimic what a person who wants to abuse your product to do at home. So you have on a lot of alcohol trials assuming people have alcohol at their house, acetone because it is used for nail polish all the way to juices and Coca-Cola. Very important work that has taken us at least seven month and we will be done with that in September and we will announce that works for you late September, early October and it will be ready for us deliver to the FDA.
The second two categories are the human abuse liability trials. Again, these are long-term extended trials from the time we started writing protocols till we will have data. It will probably take between seven and nine months. These are clinical trials where people will actually take our product.
When it’s intact and they take it when it’s crushed and they have to report back, the crushed felt like a placebo otherwise the experimental network. They cost millions of dollars and they are handled by a Canadian entity that had to have the approval of the Canadian Government as well as the FDA.
Again, the results hopefully will be done sometime toward the end of September, we’ll have a preliminary number. We will issue a final report somewhere around October. So the human in vitro studies and the in vitro studies will be ready before October. Why I am giving you these dates, because I am pushing this back on all the consultants to have them ready before we go to the FDA, pre-NDA meeting in October.
I need them to evaluate these and tell us if there is anything missing, so we can take care of it before the filing date of December 2014. The FDA asked for a pediatric study, which we have communicated to them that we’d like to do it sometime next year, was the application spending, and we have no doubt that they’ll accept, they’ll respect and that they will accept such a request.
In October, once we meet with the FDA, we’ll have them give us an assessment of the adequacy of all the data generated. Now we all interpret the regulations. We believe this is what we need to do, and then the FDA will tell you if you’ve gone to their standards or to their base or not. So we will have a lot of feedback hopefully after October from the FDA.
Again, my vision is and has been for the past year and I’ll update the view on this with every single meeting. And it was the full order of my stat to deliver a filing by December of this year, and we are on target to do that. The only thing that could delay us, as I said before, no one can stop us. Elite’s anti-abuse is coming to the market. The only entity that could delay it is if the FDA requested one more clinical trial, which will put us on lab out six months. We will know about that once we meet them in October.
Next step, what are we thinking about once we file. We believe the FDA will brand us, expedite the review and we’ll give us results probably by – or approval by September of 2015. That will be the date where we’d be launching and about a year from now, August, September of 2015. To do so we have to decide what we’re doing our product. I have made the decision we will be manufacturing ELI-200 ourselves.
I have had several companies that approached me and asked if contract manufacture for us, they have much bigger facilities and I’ve decided the product is staying with us. The marketing of the product, we have several options. We either contract the sales and marketing force, and Chris and I have been in contact with such entities and that proposals and numbers and what have you.
And the second is to have a well-established pharmaceutical company that has the capabilities and sales and marketing force of 150 to 200 people that can sell our product in addition to this at some kind of a profit sharing or commission. I have not made the decision on that part and that will have to be made by December once we file, okay.
This is the status of the ELI-200. It is the most exciting product we have right now. We are filing an application, which have never happened in the history of this company. We’re launching an awesome product. I mean this is exceptionally exciting.
We have several other products in development that we’ve updated to you on. We’ll start with the clinical trials for ELI-201, same thing with ELI-202. Again, the results and data will be available in October probably. We filed INDs for all of them. We’re in communication with FDA on what is required and all of that part is exciting, but the filing will take place in December of this year for ELI-200 and that really is our flagship.
I will not address any of the other issues there. Any time I give a presentation on what’s happening with the [IND] (ph) and all of this I get asked questions. So I’m going to arrange for you guys, but ask the questions on the rest of the issues.
And, operator, we can open now for question-and-answer.
Question-and-Answer Session
Operator
Thank you. Ladies and gentlemen, the floor is now open for questions. (Operator Instructions) Okay our first question is coming from Bob Parker. Please post your question.
Unidentified Analyst
Good morning gentlemen, congratulation again, on another great quarter. Question on what’s your expectations from the FDA when you’re filing these INDs for ELI-200 and ELI-202?
Nasrat Hakim
Good morning Bob.
Unidentified Analyst
Good morning.
Nasrat Hakim
The reason we file an IND, IND is investigational new drug application. What you do is, you get an exemption from the FDA to introduce a product that has not been approved yet into interstate commerce, okay. So whenever you make an ELI-200 and you’re going to sent it to a clinic where you are having a dosing to human beings, how do you do that when you don’t have an approval? So the IND is resistant that was created to overcome that. It also gives the FDA study base to think about whether the trial you are going to run, that’s is acceptable to them or detrimental to the human beings and will ask you to add more safety controls, okay.
Furthermore, it opens up the line of communication with FDA whereby, we would ask them a question like we did with the – in vitro with the latter studies. We said here is what we’re doing? They can bag with a very intelligent analysis saying here’s what we propose you do and that helped up to work actually that we’re going to do by quite a bit and helped us out tremendous. So that’s why you file an IND.
Unidentified Analyst
Okay. Can I follow-on with a quick one, this is in regards to the 10-Q on the expansion of your Northvale facility. Does this give the potential for ELTP to manufacture and distribute all the ART drugs without a partner?
Nasrat Hakim
Not all. If we are going to with the Hakim vision of more than a dozen, I’ll need a huge company for that. But if yes it does allow us to launch this product and probably two three others.
Operator
Thank you. Our next question is with [Steve Smith] (ph). Your line is live.
Unidentified Analyst
Gentlemen, I would like to thank you for another stronger quarter and all the hard work you’ve put it.
Carter J. Ward
Thank you, Steve.
Doug Plassche
Thanks Steve.
Unidentified Analyst
Given that Elite’s generic NDA ART line takes less time and money to bring to market then Elite’s once daily ELI-216 product can you speak to what the current plans are for this product say for instance to partner a combo ELI-201 and ELI-216 together and how quickly you are planning to move forward with this product as there is no once-daily abuse resistant product on the market to date?
Doug Plassche
Obviously that’s a very interesting question and I think about that a lot, to take products like this to market by ourselves would require a lot of money. Mr. Ward here thinks day and night on how he can get me another $50 million, but definitely all options are on the table and I have no issue and I have talked to other companies about partnering with us in order to cover the clinical trial cost.
At the end of the day my philosophy is very simple. I’m very open-minded. Whatever makes sense for Elite I will do it.
Unidentified Analyst
Okay. Just another quick question. Bob previously answered the other question I was interested in. But you had mentioned during the last conference call that there were two pharma companies that had contacted you and you didn’t realize that they were actually interested in Elite’s technology. Anything further going on with those two companies as far as talks and discussions?
Nasrat Hakim
The answer is nothing has changed for the past six weeks since we had meeting with you guys, and, yes, we have even held meetings.
Unidentified Analyst
Okay.
Nasrat Hakim
Correct. We are definitely actively pursuing that Steve.
Operator
Thank you. Our next question is from [Scott Dixon] (ph). Your line is live.
Unidentified Analyst
Good morning, gentlemen. Great job so far this quarter. Nasrat, my question is, I know you’re trying to earn for a three-year contract. Are you looking to stay on longer?
Nasrat Hakim
I’m not sure who started that rumor, but I’ve heard it before. So I went ahead and looked at my contract and it doesn’t say three years and we’re in it. So, I’m here as long as Elite needs me and as long as I’m having fun and bringing stockholder value. Since I’ve taken over a year ago the stock has increased by about 400%, 500%. We’re introducing new product to the market. As long as good stuff is happening I’m here.
If a huge company end up paying the right cash for Elite, I’m very open-minded. And they buy us tomorrow, I retire tomorrow. So definitely I could be here for the next five, 10 years and that could happen tomorrow, but I couldn’t be out sooner than three years.
Unidentified Analyst
I have one more quick question. The evaluation, you gave a three tire money value to the price. At what plane are we looking at the high end of that evaluation? What needs to happen to get there?
Doug Plassche
Well, that evaluation was based upon the products identified in our strategic plans that we are developing. And so, once those get commercialized and approved that’s probably when – that’s when the model indicates we should be approaching the high end. Now, keep in mind that valuation was really the current value of the future prospects. So when that was done last year around October, November timeframe, that was the current value assuming all of these products were to come online. So whatever the inflation rate is should be adjusted into the price in the future.
Operator
Thank you. Our next question (indiscernible). Your line is live.
Unidentified Analyst
Yes. Hello.
Carter J. Ward
Good morning.
Ashok Nigalye
Hi. Good morning.
Unidentified Analyst
Good morning. I had one question and then I’d like to follow-up with another one if there is time. In your 10-Q they mentioned something about some arbitration of Phentermine with precession dose. And I was just curious if that was going to have any impact on the supply and if there is going to be any potential fallout to that in terms of costs in that arbitration.
Doug Plassche
Okay, I don’t think it will, like any partners you have contract that says when you have disagreements you go to arbitration. We have filed to the arbitration, however, we have not gone to an arbitrator yet, our lawyers are discussing it among themselves. It has not affected the supply from us to (indiscernible) precession dosing or the pricing. And we hope to conclude and resolve issues over the coming few months.
Unidentified Analyst
Okay.
Carter J. Ward
And you see, during this whole period our revenues are increasing. So we continue to supply in sell to precision dose.
Unidentified Analyst
Okay. And that’s great lead in for the other question. In terms of the increased revenues on the 10-Q there was no mentioned operating cost excluding R&D typically you have that number, do have a number on the operating cost for the quarter minus research and development.
Carter J. Ward
Well yes, I mean if you look at the P&L statement, our operating expenses are categorized into four numbers, there’s the R&D there’s general and administrative expenses, non-cash compensation and depreciation. So they were all there, and I’ll just tell you that the G&A expense, general administrative were $626,000 I believe. Our total operating expenses were $4.8 million and now would – that’s also including the non-cash items, $4 million of that is R&D so most of it is in R&D, right.
Operator
Thank you. Our next is with [James Smith] (ph). Your line is live.
Unidentified Analyst
Good morning gentlemen, very good quarter. I appreciate everything.
Nasrat Hakim
Good morning, James.
Unidentified Analyst
I know people are thinking about this. So I’m going to ask and I don’t know how could even answer it, but can you tell me why the stock is just so flat but all it is positive news?
Nasrat Hakim
If I had the crystal ball I would. Honestly I can’t even begin to guess. Elite has had a turbulent history and that affected us a little and there aren’t a lot of negative news, some bashers here and there. But overall, if you step back and look at our achievement, especially in the last year it’s mind-boggling. And you can suppress things like this for a little while, but you cannot once there is a product that’s been submitted to FDA, you cannot – once the product that’s been approved by FDA, once hopefully we either come up with a partner or financing. So we continue with this. So the next few months are going to be really telling and I feel, this is my personal feeling, that this is going to change and over the next year, especially with an approval from FDA and a long stay of hopefully next September, nobody is going to be able to stop us.
Unidentified Analyst
I agree. Thank you very much.
Nasrat Hakim
Thanks, James.
Operator
Thank you. (Operator Instructions) Our next question is [Steve Carter] (ph). Your line is live.
Unidentified Analyst
Good morning, gentlemen. Congratulations on the quarter and thank you for the good work. And I have two quick questions and I will be quick and a follow-up from the previous person I was just on. I don’t think there was a big surprise why the price of the stock is suppressed. I think the vote for the new shares is one of the biggest reasons and I wanted to ask about that. I think there was a big concern among investors about the increased number of shares and I also wanted to ask what is happening with the possible uplifting at the stock.
Nasrat Hakim
Okay. The uplifting of the stock on the NASDAQ is one of the things that I don’t mind, and, again preliminary, I see us there in 2016. I have always said this from day one, I do believe in fundamentals. I need to see our company have solid fundamentals, earnings and revenues, which determines the price of the stock and I do not want to rush to any stock exchange and have us crash back into a penny stock. Okay. So it’s not going to happen until we file a product, get an approval and start generating revenue. I want us there for good period. And hopefully it will happen organically and the financials will support it.
As to the number of shares, and I’ve heard what you said from other callers and from few people. Maybe it is, but the fact is whenever you are a small company like us, which have an exceptional product and you don’t have money to take it all the way, you have to bring in some kind of a financing. The Lincoln Park deal has been one of the best things that this company has ever done.
Here is my analogy of why I think that is excellent. (indiscernible) on this beautiful house that’s sitting on a great mansion, but it doesn’t have a roof, and you know that if you do not invest the money in building the roof, rain is going to destroy it, okay. Bring in a 10th person who will take 10% of that in pi or pie, if you will, will be the best way for you to protect the house and have a roof on top of it and have an asset that’s valuable.
Elite was exactly like that. We had the technology that we could not take anyway, because we don’t have money and without the deal with Novel and without the deal with Lincoln Park, the company would not have increased 500% in share even though we added more share and the company would not be able to get an approval for the first half product. Yes, it is a traded, but I think it’s more than a fair one.
Unidentified Analyst
Very eloquent answer and I appreciate it. The other quick question is something that is confused me for a while. The site transfers for the generics, the CBE-30s0, and I’m tracking specifically about Isradipine. It seems like this was filed months ago and there’s been no news on what’s happening with those and I don’t understand it.
Doug Plassche
Okay. Actually it’s the [alarm] (ph). So let me walk you through it. I do believe I’ve covered this before. I apologize if you weren’t on the call or I did not emphasize them up. We made Isradipine at our facility in here at Northvale. We put it on stability. We created the CBE-30 and we filed it to the FDA. We had a strict feedback from center that they want us to – they said the CBE-30 is still open. We would like you to validate the process before you launch it. And they literally said to us, you can validate the process and launch and then notify us. So from their standpoint we can move forward.
The issues we encountered is the same issues that a lot public companies encounter. First, the API manufacturer was the only AP. We had single source API manufacturer in our application. So, in order for them to sell us product for us to go ahead and validate they requested first that we pay the PDUFA fee on their behalf. They were not using their DMF. So they wanted us to pay that. We paid it. It was like $36,000 or so.
Then they demanded that we buy all of the raw materials that go into making Isradipine. So we have to fork another chat for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot was API which is lot of API and a lot of negotiations took place between Doug Plassche and these people in order to finally to get us the API. Now that we have the API Doug needs a prioritize it and I anticipate that we will go ahead and finish that edition and launch in Q4 of this year.
There is a ton of work that’s been taking place, but it takes a while for us to be able to bring this all to conclusion and go ahead and validate and file the product or launch the product.
Operator
Thank you. (Operator Instructions) Our next question is with [Mark Barlich] (ph). Your line is live.
Unidentified Analyst
Good morning gentleman and congratulations on another great quarter and overall another great yield for Elite, good work done by the team there.
Carter J. Ward
Thank you Mark
Unidentified Analyst
Couple of questions, quick questions. You really emphasized ELI-200 and it seems obvious that you’re receiving FDA guidance on what needs to be done to get this product to market by end of the year. If it’s successful if all the tests are successful, which so far they are and everything goes as planned FDA receives it’s submission and ultimately grants the product to be produced, does that make the follow-up products that much easier as far as the processes, I mean, like ELI-201, ELI-202, can it be streamlined a little with modifications, relating specifically to that type of product? But does it make the testing process that much easier because it’s been already approved in ELI-200 and since the Elite’s test is modular, does the FDA give a more of the streamlined on the follow-up products?
Nasrat Hakim
Absolutely, okay, that is very true. It’s from the FDA standpoint than ours. A lot of this, I mean the guidance on the anti-abuse is recent so it was uncharted waters to a large extent. Once we have gone through it thoroughly with the FDA and ELI-200, then we can already anticipate what the FDA wants. For example, in vitro studies, or in the human anti-abuse studies, we can anticipate that and go ahead and be proactive and one all of these studies instead of submitting a petition to FDA and waiting to see if it’s okay. You are correct it will help a lot to expedite things in the future and possibly it could have a little bit of savings associated with it because we can bump a couple of things at the same time.
Unidentified Analyst
Excellent. And my second question, you really seem to be keying in on September, late September for some significant information. Are you coinciding this with your appearance at the Rodman Conference to have substantial presentation there with new products from Elite.
Nasrat Hakim
That really sound like it is, but it’s not. The Rodman Conference is early in the month, its eighth through tenth I believe. And the results that we are getting will be towards the end of the month and the final the reports will be in October. I am really trying to set everything to coincide with meeting with the FDA, because the more I can give them, the better guidance they can give me. The FDA are not requiring I bring anything to the pre-NDA meeting. But the more I bring them, the more feedback they’ll give me and that’s really my driving source.
Unidentified Analyst
Excellent. Thank you gentlemen again job well done.
Nasrat Hakim
Thank you Mark.
Carter J. Ward
Thank you Mark.
Operator
Thank you. Our last question for today [Sally Prasad] (ph) your line is live.
Unidentified Analyst
Hi Mr. Hakim and the rest, you’ve done a wonderful job and we’re really proud of all of your efforts. My comment is I’m sure you’ve heard of the 60 minute show where they showed hassle free trading by the big black computers, all that big banks are doing and governments staffs admitted what they do is, any stock, any stock that goes up 5% gets shorted by their computer immediately and then gets bought back and then shorted when it goes up again. This goes on all day long.
And this is something that some people are fighting it and trying to get another exchange in there already got one and the bookies have been written about it. But it’s a very deterrent thing to retail buyers, because they buy stock and then it goes down immediately. What they do is they take the cream off the coffee every time and it should be illegal and you should speak to your Congressperson and let them know be very aware of what you’re doing with the FDA and everything else, so that they will kind of keep an eye on it and kind of make sure you get fair treatment. Because let me tell you small companies many times get abused because they don’t make donations to Congressmen and all they don’t have any clout.
And one other thing I wanted to say is your stock increase in not unreasonable. The stock afloat here is a very comfortable number, and those companies that have three or four billion shares, now reputable small companies that are doing well, but not go to an exchange hence other stock is strong until the news is good is the greatest stat here because I have several that get reversed with, went to NASDAQ and got down to where they were way before the reserve split. It’s just not necessary right now for you to do that. I think you are very wise man and thank goodness you came to this company. And that’s all I want to say and thank you.
Doug Plassche
Thank you, Sally. Excellent. Thank you. Appreciate your help.
Carter J. Ward
Thank you, Sally. Good to hear from you.
Operator
We have no further questions at this time. I’d like to hand the floor back to management for closing statements.
Nasrat Hakim
Okay. Excellent work. Thank you all joining us today. This has been an extremely exciting yield for Elite. Thank you for your support and look for really good news, because excited about this company. The next few months are going to be sensational. And we’ll talk to you sometime in November.
Carter J. Ward
Thank you all.
Doug Plassche
Have a nice day.
Operator
Thank you. Ladies and gentlemen, this does conclude today’s conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
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JosephCortes
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Thanks .
Truth is ELTP presented a wonderful report.
A quick brief.
Consolidated revenues were $1.2 million for the quarter, an increase of approximately 61% over consolidated revenues for the comparable quarter of the prior year. The significant increase in revenues is due to the continued growth and expansion of Elite's generic product lines. In addition, Elite monetized its minority ownership interest in Novel Laboratories this quarter, receiving $5 million and recognizing a related gain of $1.7 million.
Development of our abuse-deterrent opioid technology continues to be Elite's top priority and we invested $4.0 million this quarter for a human abuse liability study, bioequivalence studies, and other product development activities. Elite remains on track to file its first abuse-deterrent opioid product, ELI-200, by the end of calendar 2014.
Elite's balance sheet continues to strengthen. Working capital surpluses increased from $3.8 million at the beginning of the quarter to $4.8 million as of June 30, 2014. Elite also retired the NJEDA Series B bonds and is now current with respect to all principal and interest payments due on the NJEDA Series A bonds.
Nasrat Hakim, CEO of Elite commented, "We had a solid start to our fiscal year. Our generic product lines are performing well and our pipeline of new generic products being transferred will provide further opportunities for growth. The development of our abuse-deterrent opioid products continues to progress at a rapid pace. We are on schedule to file our first product this year. In addition, Elite's balance sheet is stronger and we cured the monetary bond default, all of which provides stability for our future."
I need a little help here!!!
With such excellent news.... and today the stock goes down 8.24%.
Now, can anyone explain how is this even possible?
18 Aug, 05:31 PMReply! Report AbuseLike2
drjackho
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Explanation for Poor PPS Performance:
The last 8 weeks of poor PPS is a reflection on ELite's incompetently run PR program.
These folks Desperately need someone who knows how to develop a successful PR campaign.
18 Aug, 09:57 PMReply! Report AbuseLike0
Charles Stermetz
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There has been some manipulation for some time now... Not quite sure how people do it, but that's the only explanation.
18 Aug, 06:17 PMReply! Report AbuseLike1
terryd2518
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if you believe it's really just another opportunity to buy low ......I am
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