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I wouldn't panic over this.
They still have two patents pending due for approval that will provide added protection. Also there are several methods of extending patent protection that they are likely to take advantage of.
Actually the pediatric studies may entitle them to an extra 6 months of patent protection.
http://www.alston.com/Files/Publication/586807fa-b1be-4f2d-8915-6b383ac33233/Presentation/PublicationAttachment/4a0e8595-d857-4772-8875-ac14b8fe109e/BioPharm%20Spruill%20May2005.pdf
http://en.wikipedia.org/wiki/Term_of_patent_in_the_United_States
For applications filed on or after June 8, 1995,[1] the patent term is 20 years from the filing date of the earliest U.S. application to which priority is claimed (excluding provisional applications).[2]
See: https://www.google.com/patents/US8182836?dq=elite+pharmaceuticals+laboratories+8,182,836&hl=en&sa=X&ei=I4MVVLSJO9PgsASEuIDADA&ved=0CB0Q6AEwAA
Filing date = 12/17/2009, priority date (estimated) 4/8/2003
now see:
http://en.wikipedia.org/wiki/Priority_right
In patent law, when a priority is validly claimed, the date of filing of the first application, called the priority date, is considered to be the effective date of filing
So it's 2003 plus 20 years = 2023.
However, the priority date in Google patents is estimated so perhaps Elite has determined through the USPTO that the priority date is in 2004.
Let the cutting and pasting begin!!
"We could not be more pleased with the top line result from the Human Abuse Liability Study for ELI-200 which confirms the effectiveness of our abuse deterrent technology,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "This successful technology will be the platform for an entire line of opioid products utilizing our proprietary technology. We remain on track to file our first new drug application for ELI-200 by December 2014.”
Please explain what the scam is.
Hey, what about your question regarding Epic?
OK
So I assume you are referring to this agreement?
Just confirm so we are all on the same page.
Thanks
http://www.elitepharma.com/investor_relations.asp?goto=367
Elite Pharmaceuticals Announces Manufacturing and License Agreement for Twelve Generic Products
Northvale, New Jersey, Tuesday, October 08, 2013: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today the signing of a Manufacturing and License Agreement (“Agreement”) with Epic Pharma, LLC (“Epic”). Pursuant to the Agreement, Epic will have the right to manufacture, market and sell in the United States and Puerto Rico twelve generic products owned by Elite. Of the twelve products, Epic will have the exclusive right to market six products and the non-exclusive right to market six additional products. Epic is also responsible for all regulatory and pharmacovigilance matters related to the products and for all costs related to the site transfer for all products. Pursuant to the Agreement, Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage of the gross profit, as defined in the Agreement, and earned by Epic as a result of sales of the products. The license fee is payable monthly for the term of the Agreement. The first milestone payment is due on or before November 15, 2013. Subsequent milestone payments are due upon the filing of each product’s supplement with the U.S. Food and Drug Administration (“FDA”) and the FDA approval of site transfer for each product as specifically itemized in the agreement. The term of the License Agreement is 5 years and may be extended for an additional 5 years upon mutual agreement.
“We are delighted that Elite elected to further develop our partnership by awarding this licensing agreement to Epic for these recently acquired products. This is a natural extension of our ongoing collaboration with Elite and allows Elite to leverage Epic’s ability to manufacture on a large scale,” said Jeenarine Narine, President and COO of Epic.
Nasrat Hakim, President and CEO of Elite, stated “Epic continues to be a valuable partner to us. Epic is able to provide significant manufacturing resources for making these large volume products and this will allow Elite to maximize our profit potential for our generic business while we devote our resources to the development of our abuse resistant products utilizing our proprietary technology.”
Hyder.
You are most welcome.
I suggest reading this improved, more easy to read version in the stickies:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=105664911
Note when Nasrat states:
"I anticipate that we will go ahead and finish that edition and launch in Q4 of this year."
This needed some line breaks....
Updated below.
I took the liberty of listening to the entire CC and edited out and/or corrected all of the many poor translations from the SA version of the transcript.
I doubt I caught every error but below is a FAR more accurate representation of what was said on the CC.
Well worth it for anyone that could not call in to read THIS version.
============================
Elite Pharmaceuticals' (ELTP) CEO Nasrat Hakim on Q1 2015 Results - Earnings Call Transcript
Aug. 18, 2014 5:12 PM ET | 6 comments |
About: Elite 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) Q1 2015 Earnings Conference Call August 18, 2014 11:00 AM ET
Nasrat Hakim - President and Chief Executive Officer
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 - Chief Financial Officer
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 monetized 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 have 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 - Executive Vice President-Operations
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 work in 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 easy 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 state. 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 - President and Chief Executive Officer
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 Dianne 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 intact and they take it when it’s crushed and they have to report back, the crushed felt like a placebo otherwise the experiment will not 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 while the application was spending, and we have no doubt that they’ll accept that they expressed 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 taste 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 updated this with every single meeting. And it was the full order of my staff 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 with them in October.
Next step, what are we thinking about once we file. We believe the FDA will grant us expedited 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 one of a couple of options. We either contract the sales and marketing force, and Chris and I have been in contact with such entities and got 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 started 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 the FDA on what is required and all of that stuff 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 cause any time I give a presentation on what’s happening with the ANDA’s 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.
Bob Parker
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 - President and Chief Executive Officer
Good morning Bob.
Nasrat Hakim - President and Chief Executive Officer
Good morning Bob. 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 send 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 the system that was created to overcome that. It also gives the FDA study 30 days 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 lab studies. We said here is what we’re doing? They came back with a very intelligent analysis saying here’s what we propose you do and that helped cut the work actually that we’re going to do by quite a bit and helped us out tremendously. So that’s why you file an IND.
Bob Parker
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 - President and Chief Executive Officer
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] . Your line is live.
Steve Smith
Gentlemen, I would like to thank you for another stronger quarter and all the hard work you've put it.
Carter J. Ward - Chief Financial Officer
Thank you, Steve.
Doug Plassche - Executive Vice President-Operations
Thanks Steve.
Steve Smith
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?
Nasrat Hakim - President and Chief Executive Officer
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.
Steve Smith
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 - President and Chief Executive Officer
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.
Steve Smith
Okay.
Nasrat Hakim - President and Chief Executive Officer
Correct. We are definitely actively pursuing that Steve.
Operator
Thank you. Our next question is from [Scott Dixon] (ph). Your line is live.
Scott Dixon
Good morning, gentlemen. Great job so far this quarter. Nasrat, my question is, I know you signed on for a three-year contract. Are you looking to stay on longer?
Nasrat Hakim - President and Chief Executive Officer
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 anywhere 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 price 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 well that’s not going to happen tomorrow, but I could be out sooner than three years.
Scott Dixon
I have one more quick question. The evaluation, you gave a three tier money value to the price. At what point are we looking at the high end of that evaluation? What needs to happen to get there?
Carter J. Ward - Chief Financial Officer
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 is from Trial? Charles? Youngblood. Your line is live.
Joel Youngblood
Yes. Hello.
Carter J. Ward - Chief Financial Officer
Good morning.
Nasrat Hakim
Hi. Good morning.
Joel Youngblood
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 Precision 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.
Nasrat Hakim - President and Chief Executive Officer
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 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 TAGI or Precision Dose or the pricing. And we hope to conclude and resolve issues over the coming few months.
Youngblood
Okay.
Carter J. Ward - Chief Financial Officer
And you see, during this whole period our revenues are increasing. So we continue to supply in sell to precision dose.
Youngblood
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 - Chief Financial Officer
Well yea, 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.
James Smith
Good morning gentlemen, very good quarter. I appreciate everything.
Nasrat Hakim - President and Chief Executive Officer
Good morning, James.
James Smith
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 with all of this positive news?
Nasrat Hakim - President and Chief Executive Officer
If I had the crystal ball I would. Honestly I can’t even begin to guess. Elite has had a turbulent history and that affects us a little and there are 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 launch date of hopefully next September, nobody is going to be able to stop us.
James Smith
I agree. Thank you very much.
Nasrat Hakim - President and Chief Executive Officer
Thanks, James.
Operator
Thank you. (Operator Instructions) Our next question is [Steve Carter] (ph). Your line is live.
Steve Carter
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 up listing of the stock.
Nasrat Hakim - President and Chief Executive Officer
Okay. The up listing 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. If nine of us owns 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 entire 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 anywhere, 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 shares and the company would not be able to get an approval for the first ART product. Yes, it is a trade off, but I think it’s more than a fair one.
Steve Carter
Very eloquent answer and I appreciate it. The other quick question is something that has confused me for a while. The site transfers for the generics, the CBE-30s, 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.
Nasrat Hakim - President and Chief Executive Officer
Okay. Actually there's a lot of news 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 enough. 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 have received feedback from the 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 of other 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 check for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot of 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 to 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.
Mark Barlich
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 - Chief Financial Officer
Thank you Mark
Mark Barlich
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 tech is modular, does the FDA give a more of the streamlined on the follow-up products?
Nasrat Hakim - President and Chief Executive Officer
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 on 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 run 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.
Mark Barlich
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 - President and Chief Executive Officer
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.
Mark Barlich
Excellent. Thank you gentlemen again job well done.
Nasrat Hakim - President and Chief Executive Officer
Thank you Mark.
Carter J. Ward - Chief Financial Officer
Thank you Mark.
Operator
Thank you. Our last question for today [Sally Prescott] (ph) your line is live.
Sally Prescott
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 high speed trading by the big black computers, all that big banks are doing and Goldman Sachs 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 book 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 is not unreasonable. The stock float 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 idea 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.
Nasrat Hakim - President and Chief Executive Officer
Thank you, Sally. Excellent. Thank you. Appreciate your help.
Carter J. Ward - Chief Financial Officer
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 - President and Chief Executive Officer
Okay. Excellent work. Thank you all joining us today. This has been an extremely exciting year for Elite. Thank you for your support and look for really good news, because I am very 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 - Chief Financial Officer
Thank you all.
Doug Plassche - Executive Vice President-Operations
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.
I took the liberty of listening to the entire CC and edited out and/or corrected all of the many poor translations from the SA version of the transcript.
I doubt I caught every error but below is a FAR more accurate representation of what was said on the CC.
Well worth it for anyone that could not call in to read THIS version.
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Elite Pharmaceuticals' (ELTP) CEO Nasrat Hakim on Q1 2015 Results - Earnings Call Transcript
Aug. 18, 2014 5:12 PM ET | 6 comments | About: Elite 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) Q1 2015 Earnings Conference Call August 18, 2014 11:00 AM ET
Nasrat Hakim - President and Chief Executive Officer
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 - Chief Financial Officer
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 monetized 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 have 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 - Executive Vice President-Operations
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 work in 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 easy 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 state. 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 - President and Chief Executive Officer
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 Dianne 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 intact and they take it when it’s crushed and they have to report back, the crushed felt like a placebo otherwise the experiment will not 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 while the application was spending, and we have no doubt that they’ll accept that they expressed 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 taste 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 updated this with every single meeting. And it was the full order of my staff 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 with them in October.
Next step, what are we thinking about once we file. We believe the FDA will grant us expedited 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 one of a couple of options. We either contract the sales and marketing force, and Chris and I have been in contact with such entities and got 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 started 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 the FDA on what is required and all of that stuff 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 cause any time I give a presentation on what’s happening with the ANDA’s 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.
Bob Parker
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 - President and Chief Executive Officer
Good morning Bob.
Nasrat Hakim - President and Chief Executive Officer
Good morning Bob. 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 send 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 the system that was created to overcome that. It also gives the FDA study 30 days 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 lab studies. We said here is what we’re doing? They came back with a very intelligent analysis saying here’s what we propose you do and that helped cut the work actually that we’re going to do by quite a bit and helped us out tremendously. So that’s why you file an IND.
Bob parker
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 - President and Chief Executive Officer
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] . Your line is live.
Steve Smith
Gentlemen, I would like to thank you for another stronger quarter and all the hard work you've put it.
Carter J. Ward - Chief Financial Officer
Thank you, Steve.
Doug Plassche - Executive Vice President-Operations
Thanks Steve.
Steve Smith
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?
Nasrat Hakim - President and Chief Executive Officer
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.
Steve Smith
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 - President and Chief Executive Officer
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.
Steve Smith
Okay.
Nasrat Hakim - President and Chief Executive Officer
Correct. We are definitely actively pursuing that Steve.
Operator
Thank you. Our next question is from [Scott Dixon] (ph). Your line is live.
Scott Dixon
Good morning, gentlemen. Great job so far this quarter. Nasrat, my question is, I know you signed on for a three-year contract. Are you looking to stay on longer?
Nasrat Hakim - President and Chief Executive Officer
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 anywhere 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 price 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 well that’s not going to happen tomorrow, but I could be out sooner than three years.
Scott Dixon
I have one more quick question. The evaluation, you gave a three tier money value to the price. At what point are we looking at the high end of that evaluation? What needs to happen to get there?
Carter J. Ward - Chief Financial Officer
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 is from Trial? Charles? Youngblood. Your line is live.
Joel Youngblood Yes. Hello.
Carter J. Ward - Chief Financial Officer
Good morning.
Ashok Nigalye???
Hi. Good morning.
Joel Youngblood
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 Precision 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.
Nasrat Hakim - President and Chief Executive Officer
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 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 TAGI or Precision Dose or the pricing. And we hope to conclude and resolve issues over the coming few months.
Youngblood
Okay.
Carter J. Ward - Chief Financial Officer
And you see, during this whole period our revenues are increasing. So we continue to supply in sell to precision dose.
Youngblood
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 - Chief Financial Officer
Well yea, 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.
James Smith
Good morning gentlemen, very good quarter. I appreciate everything.
Nasrat Hakim - President and Chief Executive Officer
Good morning, James.
James Smith
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 with all of this positive news?
Nasrat Hakim - President and Chief Executive Officer
If I had the crystal ball I would. Honestly I can’t even begin to guess. Elite has had a turbulent history and that affects us a little and there are 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 launch date of hopefully next September, nobody is going to be able to stop us.
James Smith
I agree. Thank you very much.
Nasrat Hakim - President and Chief Executive Officer
Thanks, James.
Operator
Thank you. (Operator Instructions) Our next question is [Steve Carter] (ph). Your line is live.
Steve Carter
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 up listing of the stock.
Nasrat Hakim - President and Chief Executive Officer
Okay. The up listing 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. If nine of us owns 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 entire 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 anywhere, 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 shares and the company would not be able to get an approval for the first ART product. Yes, it is a trade off, but I think it’s more than a fair one.
Steve Carter
Very eloquent answer and I appreciate it. The other quick question is something that has confused me for a while. The site transfers for the generics, the CBE-30s, 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.
Nasrat Hakim - President and Chief Executive Officer
Okay. Actually there's a lot of news 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 enough. 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 have received feedback from the 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 of other 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 check for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot of 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 to 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.
Mark Barlich
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 - Chief Financial Officer
Thank you Mark
Mark Barlich
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 tech is modular, does the FDA give a more of the streamlined on the follow-up products?
Nasrat Hakim - President and Chief Executive Officer
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 on 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 run 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.
Mark Barlich
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 - President and Chief Executive Officer
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.
Mark Barlich
Excellent. Thank you gentlemen again job well done.
Nasrat Hakim - President and Chief Executive Officer
Thank you Mark.
Carter J. Ward - Chief Financial Officer
Thank you Mark.
Operator
Thank you. Our last question for today [Sally Prescott] (ph) your line is live.
Sally Prescott
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 high speed trading by the big black computers, all that big banks are doing and Goldman Sachs 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 book 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 is not unreasonable. The stock float 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 idea 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.
Nasrat Hakim - President and Chief Executive Officer
Thank you, Sally. Excellent. Thank you. Appreciate your help.
Carter J. Ward - Chief Financial Officer
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 - President and Chief Executive Officer
Okay. Excellent work. Thank you all joining us today. This has been an extremely exciting year for Elite. Thank you for your support and look for really good news, because I am very 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 - Chief Financial Officer
Thank you all.
Doug Plassche - Executive Vice President-Operations
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.
Nope couldn't find it.
Exactly!
Even the revered Novartis, Bayer, GSK and Purdue's of the world don't release BE data.
Why in the world would you expect Elite to do so?
Very funny!
LOL LOL
The statement is regarding what level trials they INCLUDE. Not exclude.
They ONLY consider Phase 2 and Phase 3 trials for release.
The full paragraph:
The provision of such data will only apply to phase 2 and 3 patient-level clinical trial data, study-level clinical trial data, and protocols in accordance with stipulations in the informed consent (ICF) signed at the time of giving consent. All patient level data will be made anonymous. If the data cannot be made anonymous, they shall not be provided.
So you are confirming to me that Purdue WILL NOT include BE trial data but you expect Elite to do so? Really?
LOL LOL!
See a pattern here?
Novartis:
Novartis announces that researchers can now request access to patient level data on newly approved innovative medicines in the United States and EU in 2014 through the ideaPoint portal...
GSK:
When studies are listed After the medicine studied has been approved by regulators (first approval) or terminated from development all indications) and the study has been accepted for publication.
Bayer:
Studies are considered for inclusion in the “Study list” (see section “Studies listed”) after regulatory approval. In case of planned scientific publications, studies will be listed once the primary manuscript describing the results has been accepted for publication.
LOL LOL
It's completely relevant.
I'll go with Camargo's excellent reputation and track record LONG before I give any weight to so called healthy skepticism.
LOL LOL
This is a very illuminating discussion about publishing trial data.
I find it interesting to note that even a big pharma company like Purdue doesn't just release trial data to the general public willy nilly.
Purdue's policy on releasing clinical data:
http://www.purduepharma.com/research-and-development/data-sharing/
This process will be limited to Purdue Pharma L.P.’s (Purdue) clinical trials involving medicines and indications approved, or those officially discontinued by Purdue, in the United States.
As you can see even the mighty Purdue won't release clinical trial data UNTIL the product is APPROVED.
So please relax. You'll get that data once ELI-200 is APPROVED and your request for data is granted.
LOL LOL
more baseless and nefarious speculation....LOL LOL
Actually the share price was .26 a week before the first trial PR.
Then it went into the .40's right after.
It rose to .97 after the 2nd PR.
Now its .317 last I looked.
So its still up.
Should the abuse liability studies be successful I can't imagine it not going up.
As is yours
Data exists. It's just not being shared. No pity at all.
This excerpt might help you and others understand why:
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are not in favour of the uncontrolled release of potentially sensitive patient data, even in anonymised form. They fear that the release of all clinical trial data could risk trade secrets, patient privacy, lead to fewer clinical trials, and result in less new medicines to meet patient needs and improve health. - See more at: http://www.oxbridgebiotech.com/review/featured/share-share-registration-reporting-clinical-trial-results/#sthash.dVIIFJ0z.dpuf
http://www.elitepharma.com/investor_relations.asp?goto=378
Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study for Abuse Deterrent Product ELI-200
“Following the success of the pilot bioequivalence study in December for ELI-201, we are delighted with the results of this pivotal bioequivalence clinical study for ELI-200, our second opioid abuse deterrent product. ELI-200 is expected to be filed this year and will be the first NDA product filed by Elite with the U.S. Food and Drug Administration.”
http://www.elitepharma.com/investor_relations.asp?goto=377
Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201
"We are delighted with the results from our clinical studies and pleased to have confirmation of the formulation for our extended release product, ELI-201, our twice-daily oxycodone product and the progress of the second opioid,"
Why does that matter?
The company has a number of patents.
Elite has several ANDA's approved one NDA to be submitted in December.
Very exciting times.
Nope. They just show a history of prices. Even "your" charts.
Nope. They just show a history of prices.
I remember when the price was .063. Now it's about five times that.
The chart of my bank account balance is looking pretty snazzy.
What expertise?
I've personally met Jimmy Joe, Nasrat, Jerry, Carter, Dianne,Ashock, and Ram. I know they are real people.
Nasrat has done wonders for the share price despite so I'll continue to trust his expertise.
Oh, and where did anyone say each NDA has 4 to 5 billion in revenue potential?
Elite has several employees and an outstanding consultant in Camargo with plenty of NDA filing expertise.
Nice article on ELTP:
https://www.pennypro.com/elite-pharmaceutical-eltp-monster-spikes-draw-speculators/
Elite Pharmaceutical (ELTP): Monster Spikes Draw Speculators
by Steve LeBlancMonday, August 11, 2014
Looking for a stock with a history of making a three-bagger within 30 days, or a five-bagger in 60 days? Well, look no further, because Elite Pharmaceutical (ELTP) is in the business of swinging for the fence and occasionally connecting for trip around the bases.
In fact, a well-written article about Elite’s potentially explosive business model can be found on Seekingalpha.com, titled, “Elite Pharmaceuticals: Swinging For The Fences”. We agree with the author, wholeheartedly. What draws many to ELTP is the stock’s dramatic and disorderly price moves.
We will not rehash an already well-presented, intelligible and still-fresh overview of Elite Pharmaceuticals as the article, mentioned above, has done. We do, however, believe that, if you’re looking for a potential home run stock to compliment your portfolio, an argument can made for seriously considering ELTP.
Case in Point
In January, ELTP started 2014 at a price just under $0.15; but by Jan. 23, the stock spiked as high as $0.375, for a gain of more than 150%. After closing at $0.26 on the first day of trading in Feb., the stock spiked again, climbing as high as $0.97 on Mar. 5, for a gain of 273% within 30 calendar days.
ELTP
Traders close to the company apparently got a whiff that revenue to be reported on Feb. 14 would jump substantially, which it did. For the period ending Dec. 31, Elite’s revenue soared to approximately $1.7 million, up from approximately $700,000 for the prior year.
Accounting for the revenue jump came from the last year’s launch of Hydromorphone, Phentermine tablets and Methadone; the current year’s launch of Phentermine capsule and naltrexone; and revenue derived from the acquisition of 12 drugs in Aug. 2013.
In addition, Elite earned a milestone payment of $600,000 from Epic Pharmaceuticals – a condition of a signed manufacturing and licensing agreement with Epic.
And consider carefully the real coup de grace to account for ELTP’s monster ride. The news came a week earlier, on Feb. 7, when Elite CEO Nasrat Hakim opted to receive voting shares for his notes in lieu of $10 million of cash. That news did wonders for the stock, doubling the price in eight trading days.
The thinking goes like this: If Hakim believes that he should let his $10 million stake ride to the end, why would investors feel compelled to bail on the stock?
Could Elite announce a dilution to cover Hakim’s compensation? Of course. It happens many, many more times than not. But that’s not what happened. Hakim took the shares, and investors cheered.
With so many micro-caps historically enriching executives at the expense of common shareholders, we find it quite unusual that anyone would be so brazen as to let $10 million ride on the outcome of a small, striving pharmaceutical enterprise.
“Nasrat [Hakim] invested $10 million in Elite and Jerry invested $600,000. There weren’t enough available shares to give to them,” Elite chief financial officer, Carter Ward, said in a Feb. conference call. “So instead they agreed to accept the convertible note payable in stock or cash. Since we need the cash, we all have the stock, they canceled their note and received Series I share, which allows them to vote like a common shareholder and ensures that Elite doesn’t have to pay them cash.”
Why the $10 million Bet Could Be a Smart Move
Elite has so many irons in the fire in way of patent and off-patent drugs – of which any (or a few) may result in a positive surprise to revenue – that stockholders who dream of that wake-up-in-the-morning ‘jackpot’ multi-bagger move higher in price could actually get their wish.
Note: Elite is merely one of many ‘jackpot’ potential micro-caps we’ll be covering for subscribers of our PennyPRO newsletter.
But, it’s gets better, still, for shareholder of ELTP.
While traders position for the potential monster pop, the company works overtime establishing steady revenue growth to support the company’s impressive abuse-deterrent product line, which Elite’s chief financial officer, Carter Ward, said is “really spectacular”.
“Spectacular”. That’s exactly what investors of ELTP want to hear. And Hakim’s varied education, experience and personal stake in the outcome of Elite are enough evidence of a stock poised for some more exciting moves to come.
My email to Dianne sent at 12:31pm EST:
What became of ELI-216 and ELI 154?
Where they renamed?
Is ELI-200 what was once ELI-216?
Her reply at 1:59pm EST:
These products are still formulations for us.
These are our once daily oxycodone formulations with and without the abuse deterrent formulations.
The company has not disclosed the opioid for ELI-200 but I don’t believe they changed the number for ELI-216.
MT:
Good question. I went back and listened to the Q22014 conference call.
Here is how you may have gotten three years in your head.
Nasrat get paid $350,000 in stock, not cash.
The stock that Nasrat is owed is accrued for and payable after three years.
In other words Nasrat receives NO COMPENSATION whatsoever for three years and then gets, essentially, $1,050,000 in stock after three years.
Pretty amazing huh?
So no, his term as CEO is not defined or limited in any way.
Exactly.
You miss my point.
They may have very well started.
Re-read my post.
Where in his employment agreement does it say that?
EXECUTION COPY; August 1, 2013
EMPLOYMENT AGREEMENT
This agreement (“ Agreement ”) is made on August 1, 2013, by and between Elite Pharmaceuticals, Inc., a Nevada corporation (“ Company ”), and Nasrat Hakim (“Executive”).
WHEREAS, Company desires Executive to be Company President and Chief Executive Officer (“CEO”) and Executive desires to provide employment services to Company in such a capacity and in accordance with the terms of this Agreement.
In consideration of the mutual promises and considerations herein contained, the parties hereby agree as follows:
A G R E E M E N T:
1. Employment .
1.1 Company hereby employs Executive in the capacity of President & CEO reporting to the Board of Directors (the “ Board ”) effective August 2, 2013. Executive hereby accepts such employment, subject to the terms herein contained. In such capacity Executive (a) shall perform such functions and duties as are required in the Company’s Bylaws and (b) shall report to and receive direction from the Board (the “Duties”). Executive shall devote such time and effort to his Duties as are reasonably necessary for him to perform such Duties in a competent and professional manner.
2. Compensation and Benefits .
2.1. Salary . During the Term (as defined below), Company shall pay to Executive a base salary at the annual rate of Three Hundred Fifty Thousand Dollars ($350,000) (the “ Salary ”). The Salary shall be paid in shares of Company’s Common Stock (“ Stock ”) pursuant to the Company’s current procedures for paying Company executives in Stock (i.e., with regards to the method of computing the number of Shares to be issued and the timing of such issuances, provided the timing is no later than March 15 th following the end of the calendar year for which payment is being made). Notwithstanding the foregoing, the payment of such Shares shall be made in a manner that does not violate Section 409A of the Internal Revenue Code of 1986, as amended (“ Section 409A ”) as discussed in Section 3.2.8 below.
2.2. Bonuses .
2.2.1 Annual Bonus . Executive shall be entitled to an annual bonus equal to 100% of Executive’s annual salary (“ Annual Bonus ”). The Annual Bonus shall be paid in Stock in accordance with the same methods utilized in Section 2.1 above. The Annual Bonus shall be paid on or before March 15 th following the end of the calendar year for which payment is being made. During the Term, the Board shall set up specific milestones to be achieved within each calendar year (“ Annual Milestones ”) and the amount of the Annual Bonus shall be payable upon the achievement of such Annual Milestones.
2.2.2 Discretionary Bonuses . In addition to the Annual Bonus, the Board may award discretionary bonuses from time to time.
8K 2013 8 5 Exhibit 10 4 Hakim Employment Agreement.DOC
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2.3. Executive Benefits .
2.3.1. Expenses . Company shall promptly reimburse Executive for all reasonable and documented travel, entertainment and other business expenses actually and properly incurred by him in relation to Company’s business. No such expense reimbursement shall be allowed with regard to such expenses that exceed $10,000 unless such expenses have been pre-approved by Company in writing. Such expense reimbursement shall include reasonable hotel accommodations and/or housing incurred by Executive specifically related to his duties under this Agreement against receipts or other appropriate written evidence of such expenditures as required by the appropriate Internal Revenue Service regulations or by Company.
2.3.2. Company Plans . Executive shall be entitled to participate in such employee benefit plans and programs as Company may from time to time generally offer or provide to senior executive officers of Company, including medical and retirement plans. Nothing in the foregoing shall limit or restrict Company’s discretion to amend, revise or terminate any benefit or plan without notice to or consent of Executive.
2.3.3. Vacation . Executive shall be entitled to four (4) weeks of paid vacation per Fiscal Year, pro rated for periods of less than a full Fiscal Year.
2.3.4. Automobile Allowance . During the Term, Company shall reimburse Executive One Thousand Five Hundred Dollars ($1,500) per month for automobile expenses and/or car lease.
3. Employment Term; Termination .
3.1. Employment Term . Executive’s employment hereunder shall commence on August 1, 2013 (the “ Commencement Date ”).
3.2. Events of Termination . Executive’s employment may be terminated as follows:
3.2.1 Termination for Cause . This Agreement may be terminated by Company for Cause. For purposes of this Agreement, “ Cause ” justifying the termination of this Agreement by Company is defined as: (1) failure or refusal to perform the services required hereunder; (2) a material breach by Executive of any of the terms of this Agreement; or (3) Executive’s conviction of a crime that either results in imprisonment or involves embezzlement, dishonesty, or activities injurious to Company or its reputation. Following termination pursuant to this subsection, Company’s only obligation to Executive shall be to pay to Executive all accrued Annual Salary and all accrued vacation time (both payable in Stock computed in the same manner as set forth in Section 2.1) and any reasonable and necessary business expenses incurred by Executive in connection with his duties, all to the Date of Termination and payable in a lump sum, less applicable deductions and withholdings, as soon as administratively practicable following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs. Notwithstanding the foregoing, any expense reimbursement will take place no later than the time required under Section 409A.
2
3.2.2 Disability . This Agreement may be terminated by Company upon at least thirty (30) days’ written notice if Executive is prevented by illness, accident or other disability (mental or physical) from performing the essential functions of the position for one or more periods cumulatively totaling three (3) months during any consecutive twelve (12) month period. In the event this Agreement is terminated pursuant to this subsection, Company shall pay to Executive all accrued Salary, pro rata Annual Bonus, and all accrued vacation time (all payable in Stock computed in the same manner as set forth in Section 2.1) and any reasonable and necessary business expenses incurred by Executive in connection with his duties, all to the Date of Termination and payable in a lump sum, less applicable deductions and withholdings. In addition, Company shall pay to Executive severance payments in an amount equal to one (1) year of Executive’s Salary, payable in Stock computed in the same manner as set forth in Section 2.1 and payable in a lump sum, less applicable deductions and withholdings, as soon as administratively practicable (but in no event later than 60 days) following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs (“ Disability Severance Payments ”). Disability Severance Payments made by Company to Executive pursuant to this Section 3.2.2 are conditioned on the Executive signing a Confidential Severance Agreement and Release. Notwithstanding the foregoing, any expense reimbursement will take place no later than the time required under Section 409A
3.2.4 Death . This Agreement shall be automatically terminated in the event of Executive’s death during the Term of employment. In the event this Agreement terminates upon Executive’s death, Company shall pay Executive’s estate or beneficiary, as applicable, all accrued Salary, pro rated Annual Bonus and all accrued vacation time (both payable in Stock computed in the same manner as set forth in Section 2.1) and any reasonable and necessary business expenses incurred by Executive in connection with his duties, all to the Date of Termination and all payable in a lump sum, less applicable deductions and withholdings, as soon as administratively practicable (but in no event later than 60 days) following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs.
3.2.5 Without Cause . This Agreement may be terminated by Company without Cause by giving Executive notice at least thirty (30) days prior to the effective date (“ Date of Termination ”); provided that Company pays Executive each of the following:
(i) Company shall pay Executive severance payments, payable in Stock computed in the same manner as set forth in Section 2.1 (the “ Severance Payments ”) in an amount equal to two (2) years’ Salary at the rate in effect upon the Date of Termination , less applicable deductions and withholdings , as soon as administratively practicable (but in no event later than 60 days) following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs. In addition, Company shall pay to Executive all accrued Salary, prorated Annual Bonus and all accrued vacation time (both payable in Stock computed in the same manner as set forth in Section 2.1) and any reasonable and necessary business expenses incurred by Executive in connection with his duties, all to the Date of Termination and payable in a lump sum , less applicable deductions and withholdings , as soon as administratively practicable (but in no event later than 60 days) following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs.
3
(ii) If the Company has a health insurance plan for its employees and Executive is covered under such plan, provided that Executive timely elects continuation coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“ COBRA ”), Company shall pay, on Executive’s behalf, the portion of premiums of Executive’s group health insurance, including coverage for Executive’s eligible dependents, that Company paid immediately prior to Executive’s separation of employment with Company (“ COBRA Payments ”) for a period of twelve (12) months following the Date of Termination (“ COBRA Period ”). Company will pay such COBRA Payments for Executive’s eligible dependents only for coverage for which those dependents were enrolled immediately prior to the date of Executive’s separation of employment. Executive will continue to be required to pay that portion of the premium of Executive’s health coverage, including coverage for Executive’s eligible dependents, that Executive was required to pay as an active employee immediately prior to the date of Executive’s separation of employment. For the balance of the period that Executive is entitled to coverage under COBRA after the COBRA Period, if any, Executive shall be entitled to maintain coverage for Executive and Executive’s eligible dependents at Executive’s sole expense.
(iii) The Severance Payments and the COBRA Payments (if any) shall be paid so long as Executive is not in breach of any term of this Agreement, including, without limitation, Sections 4, 5, 6, 7 and 8. The Severance Payments and COBRA Payments (if any) made by Company to, or on behalf of, Executive are conditioned on the Executive signing a Severance Agreement and Release.
3.2.6 Resignation . This Agreement may be terminated by Executive for any reason or no reason at all by giving notice to Company of Executive’s resignation at least sixty (60) days prior to the effective resignation date. Following termination pursuant to this subsection 3.2.6, Company’s only obligation to Executive shall be to pay to Executive all accrued Salary and all accrued vacation time (both payable in Stock computed in the same manner as set forth in Section 2.1) and any reasonable and necessary business expenses incurred by Executive in connection with his duties, all to the Date of Termination and payable in a lump sum, less applicable deductions and withholdings no later than March 15 th following the end of the calendar year in which such termination occurs.
3.2.7. Termination Upon Change of Control . Upon “Change of Control” as defined in section 3.3.1, Executive is entitled to a payment in an amount equal to two (2) years Annual Salary in effect upon the Date of Termination , less applicable deductions and withholdings , payable in Stock computed in the same manner as set forth in Section 2.1 as soon as administratively practicable (but in no event later than 60 days) following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs. Executive also shall be entitled to a continuation of his Executive benefits for a period of (2) two years from the Date of Termination. In addition, Company shall pay to Executive all accrued Annual Salary, pro rated Annual Bonus and all accrued vacation time (both payable in Stock computed in the same manner as set forth in Section 2.1) and any reasonable and necessary business expenses incurred by Executive in connection with his duties, all to the Date of Termination and payable in a lump sum , less applicable deductions and withholdings , as soon as administratively practicable (but in no event later than 60 days) following Executive’s termination, but in no event later than March 15 th following the end of the calendar year in which such termination occurs. In addition any securities of the Company owned by Executive and subject to vesting schedules shall immediately vest.
4
3.2.8 Section 409A Compliance .
(i) All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred by the Executive during the time periods set forth in this Agreement. All reimbursements shall be paid as soon as administratively practicable, but in no event shall any reimbursement be paid after the last day of the taxable year following the taxable year in which the expense was incurred. The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year. Such right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.
(ii) To the extent that any of the payments or benefits provided for in Section 3 are deemed to constitute non-qualified deferred compensation benefits subject to Section 409A of Code, the following interpretations apply: (A) Any termination of the Executive’s employment triggering payment of benefits under Section 3 must constitute a “separation from service” under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) before distribution of such benefits can commence. To the extent that the termination of the Executive’s employment does not constitute a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) (as the result of further services that are reasonably anticipated to be provided by the Executive to the Company or any of its affiliates, at the time the Executive’s employment terminates), any benefits payable under Section 3 that constitute deferred compensation under Section 409A of the Code shall be delayed until after the date of a subsequent event constituting a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h). For purposes of clarification, this Section 3.2.8(ii) shall not cause any forfeiture of benefits on the Executive’s part, but shall only act as a delay until such time as a “separation from service” occurs. (B) If the Executive is a “specified employee” (as that term is used in Section 409A of the Code and regulations and other guidance issued thereunder) on the date his separation from service becomes effective, any benefits payable under Section 3 that constitute non-qualified deferred compensation under Section 409A of the Code shall be delayed until the earlier of (1) the business day following the six-month anniversary of the date his separation from service becomes effective, and (2) the date of the Executive’s death, but only to the extent necessary to avoid such penalties under Section 409A of the Code. On the earlier of (3) the business day following the six-month anniversary of the date his separation from service becomes effective, and (4) the Executive’s death, the Company shall pay the Executive in a lump sum the aggregate value of the non-qualified deferred compensation that the Company otherwise would have paid the Executive prior to that date under Section 5(b) of this Agreement. (C) It is intended that each installment of the payments and benefits provided under Section 3 shall be treated as a separate “payment” for purposes of Section 409A of the Code; and neither the Company nor the Executive shall have the right to accelerate or defer the delivery of any such payments or benefits except to the extent specifically permitted or required by Section 409A of the Code.
(iii) It is the intention of the parties that payments or benefits payable under this Agreement not be subject to the additional tax imposed pursuant to Section 409A of the Code. To the extent such potential payments or benefits could become subject to such Section, the parties shall cooperate to amend this Agreement with the goal of giving Executive the economic benefits described herein in a manner that does not result in such tax being imposed.
5
3.2.9. Termination of Employment . This Agreement shall terminate simultaneously with the termination of Executive’s employment for any reason; provided , that the covenants set forth in Sections 3, 4, 5, 6, 7 and 8 of this Agreement shall survive the termination of this Agreement to the extent provided in such Sections.
3.3. Definitions .
3.3.1. “Change of Control” Defined . The term “ Change of Control ” shall mean (a) the acquisition of Company pursuant to a consolidation of Company with, or merger of Company with or into, any other Person with the result of which the holders of Company’s voting stock immediately prior to such transaction hold less than fifty (50%) percent of the combined voting power after giving effect to such transaction; (b) the sale of all or substantially all of the assets or capital stock of Company to any other Person; or (c) securities of Company representing greater than fifty (50%) percent of the combined voting power of Company’s then outstanding voting securities are acquired by a Person, or group of related Persons, in a single transaction or series of related transactions.
3.3.2. “Notice of Termination” Defined . “ Notice of Termination ” means a written notice that indicates the specific termination provision relied upon by Company or Executive.
3.3.3. “Date of Termination” Defined . “ Date of Termination ” means such date as Executive’s employment expires as written in the Notice of Termination.
4. Conflicts of Interest . Company and Executive acknowledge that Executive is the owner, President and CEO of Mikah Pharma LLC (“Mikah”). Company and Executive will sign a separate agreement concluding any potential conflict to the satisfaction of both parties and Executive agrees to comply with such agreement.
5. Proprietary Information .
5.1 Executive represents and warrants to Company that (i) Executive is not subject to any limitation or agreement restricting employment by Company or performance of Executive’s Duties hereunder, and (ii) neither Executive nor any third party has any right or claim to Executive’s work produced on behalf of Company or using the property, personnel, or facilities of Company. Executive shall not misappropriate proprietary rights of Company or any third party.
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5.2 Executive further agrees not to make, use, disclose to any third party, or permit to be made, used, or disclosed, any records, plans, papers, articles, notes, memoranda, reports, lists, records, drawings, sketches, specifications, software programs, data, or other materials of any nature relating to any matter within the scope of the business of Company or concerning any of its dealings or affairs (“ Materials ”), whether or not developed, in whole or in part, by Executive and whether or not embodying Confidential Information (defined below), otherwise than for the benefit of Company. Executive shall not, on and after the Date of Termination, use, disclose, or permit to be used or disclosed, any such Materials, it being agreed that all such Materials shall be and remain the sole and exclusive property of Company. Immediately upon the Date of Termination, Executive shall deliver all such Materials, and all copies thereof, to Company, at its designated office.
6. Non-Competition; Non-Solicitation; Anti-Raiding; Non-Disparagement . Without the prior written approval of the Board, Executive shall not, directly or indirectly, during his employment and until the end of one (1) year after the Date of Termination (however such termination occurs, including, without limitation, termination pursuant to Section 3.2):
6.1 Solicit, offer employment to, otherwise attempt to hire, or assist in the hiring of any employee or officer of Company or any of its Affiliates; (ii) encourage, induce, assist or assist others in inducing any such person to terminate his or her employment with Company or any of its Affiliates; or (iii) in any way interfere with the relationship between Company or any of its Affiliates and their employees; or
6.2 Make any public statement or perform or do any other act prejudicial or injurious to the reputation or goodwill of Company or any of its Affiliates or otherwise interfere with the business of Company or any of its Affiliates.
6.3 Notwithstanding anything to the Contrary in Subsection 6.1, Mikah shall have the right to continue the business previously established for the Morphine Sulfate ODT and Trimipramine, products including manufacturing and/or sales of the product through third party contracts.
7. Confidentiality .
7.1 The term “Confidential Information” shall include, but not be limited to confidential information and the workpapers, concepts, formulas, techniques, strategies, components, programs, reports, studies, memoranda, correspondence, materials, manuals, records, data, technology, financial information, products, plans, research, service, design information, procedures, methods, documentation, policies, pricing, billing, customer lists and leads, and any other technical data, information and know-how which relates to products or customers or potential customers or suppliers or potential suppliers or are otherwise useful in the parties' businesses, and which one of the parties considers proprietary and desires to maintain confidential. Confidential Information is entitled to protection hereunder whether or not such information is oral or written, whether or not such information is identified as such by an appropriate stamp or marking on each document provided or, if orally first provided, identified at that time as proprietary or confidential. In addition, Confidential Information shall include information developed by the Executive in the performance of his Duties under this Agreement. All such Confidential Information is extremely valuable and is intended to be kept secret to Company; is the sole and exclusive property of Company or its Affiliates; and, is subject to the restrictive covenants set forth herein. The term Confidential Information shall not include any information generally available to the public or publicly disclosed by Company (other than by the act or omission of Executive), information disclosed to Executive by a third party under no duty of confidentiality to Company or its Affiliates, information that Executive can demonstrate was in his possession prior to the date of this Agreement or Executive can demonstrate was independently developed by him without the use or assistance of Confidential Information, or information required by law or court order to be disclosed by Executive.
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7.2 Executive shall not, without Company’s prior written approval, use, disclose, or reveal to any person or entity any of Company’s Confidential Information, except as required in the ordinary course of performing duties hereunder. Executive shall not use or attempt to use any Confidential Information in any manner which has the possibility of injuring or causing loss, whether directly or indirectly, to Company or any of its Affiliates.
7.3 In the event that Executive’s employment with Company is terminated for any reason whatsoever, he shall return to Company, promptly upon Company’s written request therefore, any documents, photographs, tapes, discs, memory devices, and other property containing Confidential Information which were received by him during his employment, without retaining copies thereof.
8 Assignment of Intellectual Property .
8.1. Executive shall promptly disclose to Company any and all Inventions (as defined below). Executive shall promptly communicate to Company all information, details and data pertaining to any Inventions in such form as Company requests. Executive agrees that Inventions, patents and patent applications are the property of Company, and any and all rights, titles or interests in and to Inventions, patents or patent applications which Executive may have in any and every jurisdiction are hereby assigned in full. Whenever Executive is requested to do so by Company, during or after the Term, Executive shall, at the Company’s sole cost and expense, promptly execute and deliver any and all applications, assignments or other documents or instruments reasonably deemed necessary or advisable by Company to apply for and obtain Letters Patent of the United States or any foreign country or to otherwise protect, confirm or establish Company’s full and exclusive interests in any Inventions. The obligations set forth in this Section 8.1 shall be binding upon the successors, assigns, executors, administrators and other legal representatives of Executive.
8.2 Any and all Works for Hire (as defined below) shall be considered “works made for hire” under the copyright laws of the United States or property of Company under applicable federal, state, local and foreign trademark laws (as appropriate). Executive shall promptly communicate to Company any and all Works for Hire, and any and all information, details and data pertaining to any Works for Hire, in such form as Company requests. To the extent that Works for Hire fail to qualify as (A) “works made for hire” under the copyright laws of the United States or any other jurisdiction or (B) property of Company under applicable federal, state, local or foreign trademark laws, Executive hereby assigns each Work for Hire and all right, title and interest therein in any and every jurisdiction to Company. Whenever Executive is requested to do so by Company, during or after the Term, Executive shall, at the Company’s sole cost and expense, promptly execute and deliver any and all applications, assignments or other documents or instruments reasonably deemed necessary or advisable by Company to apply for and confirm and effectuate full and exclusive ownership of Works for Hire in Company, including, but not limited to, ownership of any moral rights under the copyright law of any nation, or any other rights under the intellectual property laws of any nation. The obligations set forth in this Section 8.2 shall be binding upon the successors, assigns, executors, administrators and other legal representatives of Executive.
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8.3 If a court declares that any term or provision of this Section 8 is invalid or unenforceable, the parties to this Agreement agree that the court making the determination of invalidity or unenforceability shall have the power to reduce the scope, duration or area of the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified.
8.4 Definitions .
8.4.1 “Inventions” Defined . “ Inventions ” means any and all inventions, discoveries, improvements, patent, copyrights and/or other property rights, whether or not patented or patentable made, conceived, created, developed or contributed to by Executive during the Term which are (i) directly or indirectly related to the business, operations or activities of the Company or any of its subsidiaries or affiliates, (ii) directly or indirectly related to Executive’s employment by, or performance of other services (including as a director, manager, officer, advisor, agent, representative, consultant or other independent contractor) for, the Company or any of its Affiliates, or (iii) based upon Confidential Information.
8.4.2 “Work for Hire” Defined . “ Work for Hir e” means any and all sales approaches, sales material, training material, computer software, documentation, other copyrightable works or any other intellectual property (including, but not limited to, materials or services subject to trademark or service mark registration, but excluding Inventions) made, conceived, created, developed or contributed to by Executive during the Term and which are (i) directly or indirectly related to the business, operations or activities of the Company or any of its Affiliates, (ii) directly or indirectly related to Executive’s employment by, or performance of other services (including as a director, manager, officer, advisor, agent, representative, consultant or other independent contractor) for, the Company or any of its Affiliates, or (iii) based upon Confidential Information.
9. Acknowledgments; Equitable Remedies . Executive acknowledges that the covenants contained in Sections 4, 5, 6, 7 and 8, including those related to duration, geographic scope, and the scope of prohibited conduct, are reasonable and necessary to protect the legitimate interests of Company. He further acknowledges that the covenants contained in Sections 4, 5, 6, 7 and 8 are designed, intended, and necessary to protect, and are reasonably related to the protection of, Company’s proprietary information, to which he will be exposed and with which he will be entrusted. Specifically, without limitation, Executive is entrusted with trade secrets regarding: Inventions, the strategic planning initiatives; business development plans; budgets; financial information; management training; future business plans; and operational strategies and procedures. Executive understands that any breach of Sections 5 or 7 will also constitute a misappropriation of Company’s proprietary rights, and may constitute a theft of Company’s trade secrets under applicable local, state, and federal statutes, and will result in a claim for injunctive relief, damages, and/or criminal sanctions and penalties against Executive by Company, and possibly others. Executive acknowledges that any breach of Sections 4, 5, 6, 7 or 8 will cause Company immediate and irreparable injury and damage, for which monetary relief would be inadequate or difficult to quantify. Company will be entitled to, in addition to all other remedies available to it, injunctive relief and specific performance to prevent a breach and to secure the enforcement of Sections 4, 5, 6, 7 or 8. Executive further acknowledges that the covenants set forth in Sections 4, 5, 6, 7 and 8 shall survive the Date of Termination in accordance with their terms
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10. Miscellaneous Provisions .
10.1 Severability . If, in any jurisdiction, any term or provision hereof is determined to be invalid or unenforceable, (a) the remaining terms and provisions hereof shall be unimpaired; (b) any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such term or provision in any other jurisdiction; and (c) the invalid or unenforceable term or provision shall, for purposes of such jurisdiction, be deemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision.
10.2 Execution in Counterparts . This Agreement may be executed in one or more counterparts, and by the two parties hereto in separate counterparts, each of which shall be deemed to be an original and all of which taken together shall constitute one and the same agreement (and all signatures need not appear on any one counterpart), and this Agreement shall become effective when one or more counterparts has been signed by each of the parties hereto and delivered to each of the other parties hereto. This Agreement, once executed by a Party, may be delivered to the other Party hereto by facsimile or electronic transmission of a copy of this Agreement bearing the signature of the Party so delivering this Agreement. A faxed or electronically delivered signature shall have the same legally binding effect as an original signature.
10.3. Notices . All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed duly given upon receipt when delivered by hand, overnight delivery or facsimile (with confirmed delivery), or three (3) business days after posting, when delivered by registered or certified mail or private courier service, postage prepaid, return receipt requested, as follows:
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If to Company, to:
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, New Jersey
Facsimile No.: (201) 391-7693
Attn: Chairman
If to Executive, to:
Nasrat Hakim
20 Kilmer Drive
Hillsborough, New Jersey, 08844
Facsimile No.: (908) 450-1318
or to such other address(es) as a party hereto shall have designated by like notice to the other parties hereto.
10.4. Amendment . No provision of this Agreement may be modified, amended, waived or discharged in any manner except by a written instrument executed by both Company and Executive.
10.5. Entire Agreement . Except as specifically provided herein, this Agreement constitutes the entire agreement of the parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings of the parties hereto, oral or written. Company and Executive shall execute and deliver all such further documents as may be necessary to carry out the intent of the preceding sentence.
10.6. Applicable Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey applicable to contracts made and to be wholly performed therein.
10.7. Headings . The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Agreement.
10.8. Binding Effect; Successors and Assigns . Executive may not delegate any of his duties or assign any of his rights hereunder. This Agreement shall inure to the benefit of, and be binding upon, the parties hereto and their respective heirs, legal representatives and beneficiaries, successors and permitted assigns. Company shall require any successor (whether direct or indirect and whether by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of Company, by an agreement in form and substance reasonably satisfactory to Executive, to expressly assume and agree to perform this Agreement in the same manner and to the same extent that Company would be required to perform if no such succession had taken place.
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10.9. Waiver . The failure of either of the parties hereto to at any time enforce any of the provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision , nor to in any way affect the validity of this Agreement or any provision hereof or the right of either of the parties hereto thereafter to enforce each and every provision of this Agreement. No waiver of any breach of any of the provisions of this Agreement shall be construed or deemed to be a waiver of any other or subsequent breach.
10.10. Capacity, etc. Each of Executive and Company hereby represents and warrants to the other that, as the case may be: (a) he or it has full power, authority and capacity to execute and deliver this Agreement and to perform his or its obligations hereunder; (b) such execution, delivery and performance shall not (and with the giving of notice or lapse of time or both would not) result in the breach of any agreements or other obligations to which he or it is a party or he or it is otherwise bound or violate any law; and (c) this Agreement is his or its valid and binding obligation enforceable in accordance with its terms.
10.11. Enforcement; Jurisdiction . If any party institutes legal action to enforce or interpret the terms and conditions of this Agreement, the prevailing party shall be awarded reasonable attorneys’ fees at all trial and appellate levels and the expenses and costs incurred by such prevailing party in connection therewith. Any legal action, suit or proceeding, in equity or at law, arising out of or relating to this Agreement shall be instituted exclusively in the State or Federal courts located in the State of New Jersey and each party agrees not to assert, by way of motion, as a defense or otherwise, in any such action, suit or proceeding, any claim that such party is not subject personally to the jurisdiction of any such court, that the action, suit or proceeding is brought in an inconvenient forum, that the venue of the action, suit or proceeding is improper or should be transferred, or that this Agreement or the subject matter hereof may not be enforced in or by any such court. Each party further irrevocably submits to the jurisdiction of any such court in any such action, suit or proceeding. Any and all service of process and any other notice in any such action, suit or proceeding shall be effective against any party if given personally or by registered or certified mail, return receipt requested or by any other means of mail that requires a signed receipt, postage prepaid, mailed to such party as herein provided. Nothing herein contained shall be deemed to affect or limit the right of any party to serve process in any other manner permitted by applicable law.
10.12. Advice of Counsel . Executive represents and warrants that he has had full opportunity to seek advice and representation by independent counsel of his own choosing in connection with the interpretation, negotiation and execution of this Agreement.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto as of the date first above written.
Elite Pharmaceuticals, Inc.
By:
Name: Jerry Treppel
Title: Chairman & Chief Executive Officer
By:
Name: Nasrat Hakim
MT:
Is this what you are referring to?
"Sometime end of March or April, we will start another BE pivotal study for the once-a-day."
The "once a day" Oxy was ELI-154 (non-ART) or ELI-216. These don't show on the pipeline page. Not sure if they were renamed or what.
I sent a note to Diane asking for clarification.
ELI-201 is the twice daily abuse deterrent oxycodone/naltrexone product so we know that wasn't it. Pivotal trials started in July for this: http://www.elitepharma.com/investor_relations.asp?goto=388
ELI-200 is Elite’s undisclosed abuse deterrent opioid product. Some speculate it could be "a better Embeda" or it could be ELI-216 renamed. But hey, it's undisclosed so it could be anything. It could very well be what they referred to above. Pivotal study for this was announced as completed on 3/5/2014. See: http://www.elitepharma.com/investor_relations.asp?goto=378
ELI-202 is also an undisclosed Abuse resistant opiod product. So that could be it. Pivotal trial commenced in May. Press release here:
http://globenewswire.com/news-release/2014/05/19/637479/10082202/en/Elite-Pharmaceuticals-Initiates-Pivotal-Bioequivalence-Study-for-Third-Opioid-Abuse-Deterrent-Product.html
Ask Dianne in IR!
Investor Relations:
Dianne Will
(201) 367-7889
E Mail: dianne@elitepharma.com
MT:
Perhaps send an email to Diane in investor relations. She is very responsive. Do share her response with us.
Also, could you point us to the quote where Nasrat stated trials for ELI-216 would begin in March or April? Was it in a conference call? The shareholders meeting? I could not find a reference in either the transcripts or the SHM notes in the sticky.
Best,
Hike
Lasers:
By "early approvals to begin manufacturing 2014/2015" you mean for the purpose of conducting clinical trials correct?
all an IND does is make it OK to ship drugs across state lines.
Trials still need to be conducted, NDA's filed and approved correct?
You are most welcome
Inventories = $2,525,915
Next Q could be pretty good too!
A fathers love actually!
What makes you assume that is the cause?