Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc.

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Elite Pharmaceuticals, Inc. (ELTP) Q2 2015 Earnings Call Transcript

Published at 2014-11-19 17:49:02
Executives
Nasrat Hakim - President and CEO Carter J. Ward - CFO Doug Plassche - EVP Operations
Operator
Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals Conference Call. At this time all lines have been placed on a listen-only mode and we will open the floor for your questions and comments following the main presentation. [Operator Instructions]. Before management begins speaking the company has the following statement. This conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this conference call, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, its ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval processes, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These risks and other factors, including, without limitation, the company’s ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and other approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the company’s ability to operate as a going concern, are discussed in Elite’s filings with the Securities and Exchange Commission, included in its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Financial Officer of Elite Pharmaceuticals. Sir, the floor is yours.
Nasrat Hakim
Thank you, Dave. And good morning, ladies and gentlemen and thank you for calling today. Before I begin I just would like to make a statement that I do have a sore throat today and I am speaking through a cell phone because I am on the West Coast. I did not want to forfeit the opportunity of speaking to you. Inspite of this little handicap I wanted to make sure I still I am on the conference. Today’s call will follow the same format as previous calls. Our Chief Financial Officer, Carter Ward, will give us a financial update, our EVP of Operations, Doug Plassche will give us a brief update on operations and I’ll come back with the summary at the end and closing remarks. Carter, the floor is yours. Carter J. Ward: Thank you, Nasrat and thanks everyone calling in today. Last Friday we filed our 10-Q for the quarter and six months ended September 30, 2014. So we’re on a March fiscal year. That means the September quarter is the second quarter of our fiscal year, the halfway point. Before getting into the financials I want to point out a disclosure which is usually overlooked, that would be at the beginning of the 10-Q Elite’s status there is a checkbox that our status as a smaller reporting company. Reporting status is determined annually at the halfway mark of our fiscal year and it’s based upon our market cap. Smaller reporting companies have market caps of less than $75 million. This year for the first time, at September 30th our market cap was above $75 million. So as of September 30th we had a market capital of $190 million as compared to just $61 million a year ago. So the market cap more than tripled and our stock price increased almost as much from $0.12 to $0.32 in the year. So thank you to our investors for their interest in Elite, thanks to you we have moved up to accelerated filer status that will take effect for our next 10-K filing at the March, the Annual Report. That’s another milestone achieved by our growing company. So now on to the financials, which are as always they’re available at elitepharma.com sec.gov, Google, Agro-Pro, OTC markets all the usual places. Hopefully all of you have had a chance to review the financials and today I’d like to start on the balance sheet and specifically the status of our bond liability and its effect on working capital. During this quarter we finally cured the long standing bond default. We retired the Series B which we had a 9% interest rate and we caught up on all payments that were due on the Series A 6.5% bonds. That was a total of $1.1 million paid to the bonds to bring us current during the quarter. Now these payments have resulted in a number of positive effects for the company. First, we’ve cured the monetary default which had been hanging over us for almost six years. This removes a major threat to the company’s ability to operate as a growing concern. Second, the removal of the monetary default has been positive with respect to the management of our supply chain function. We now qualify for credit terms from vendors which had previously required advanced payments. Now may not sound like much, but these are the things that facilitate greater efficiencies and help support our growth. As we are growing it’s important that we continue to improve our operations and this is something that definitely helps in that regard. Third, we now have a clean opinion from our auditors. In the past the bond situation resulted in a going concern qualification. Getting a clean opinion has had a positive effect with regards to our access to infrastructure financing at competitive rates, which we now able to get. And lastly we retired $0.25 million that was costing us 8% and $900,000 that was at 6.5% interest. That’s money which we can now invest in Elite as opposed to paying it out in interest. In addition to these benefits curing the default means we can now allocate the remaining bond liability between current and long-term portions on our balance sheet. So an accounting entry that results in almost $3.2 million being moved from current liabilities to long-term liabilities. Better said, this results in $3.2 million increase in working capital. While it’s just a balance sheet re-class it’s an important one when it’s viewed by our vendors and our banks. So this is a re-class that has had quite a positive effect with regards to supporting continued growth in the company. So let’s now move on to the income statement. Revenues for the quarter were $1.3 million. That’s an 8% increase, 8% over last year’s quarter and 8% over the June quarter as well. Keep in mind that last year’s revenues were up more than 80% as well, so we took a huge increase from last year and we built on it even more. It’s solid, continued and sustained growth. That’s our objectives and our financials show that is exactly what is happening. We’re expecting at least one new product launch this year with Isradipine and perhaps the second before the end of the fiscal year. In addition, we expect a much greater contribution from Phendimetrazine in 2015. These will further broaden and increase our generic revenue streams, with additional generic products in the pipeline also moving towards commercialization. Moving down the income statement, the big line item is obviously research and development. R&D costs were $3.6 million for the quarter and $7.6 million for the six months ended September 30. The R&D spend this year is more than 5.5 times the spend through the first half of last year. Nasrat will give you a more detailed status report of R&D activities, but from a financial perspective these are costs that GAAP requires us to expense when incurred. They’re expensed as oppose to being capitalized. During this period we successfully completed a human abuse liability study for ELI-200 and we have other trials and activities ongoing. There are significant costs related to these activities and our P&L statement clearly demonstrates this. I think the most important factor from a financial standpoint to consider with regards to R&D costs, is to also look at our balance sheet and our working capital. By that I mean if you look at the balance sheet $7.6 million in cash, $4.1 million in working capital and $2.5 million in inventory. These are the resources and a critical mass to support the financial requirements of commercializing ELI-200 as our first abuse resistant opioid. The resources are in place and they are available and that’s a big deal as in the past finance was always an impediment to R&D. That’s no longer the case and our financials, both the P&L and the balance sheet clearly demonstrate this. So we’re well set to continue with our activities as planned. Well that's it from me. Now our Executive Vice President, Mr. Douglas Plassche will give an operations update.
Doug Plassche
Thank you, Carter, good morning everyone. Q2 was busy for operations. We had extensive R&D batch manufacturing to support clinical trials as well as significant optimization work on what I’ll call the next generation of the key intermediate. The formulation looks excellent, stability results look good and we are ready to start factoring this next generation into the best of the portfolio of products as we proceed. We purchased and are preparing to install a commercial scale fluid bed process with a capacity of approximately 1,000 kilos a batch, versus our current maximum of 200 kilos per batch. With this capacity we should be able to achieve our target for ELI-200 and possibly the second product as well, depending on the market penetration. While we’re building the space out we are satisfying our need for continued growth and we’re basically doubling the useful space as well as all the supports, utilities and other warehouse ancillary spaces and wall [ph] space. So it’s a pretty sizable undertaking and should position us well to grow certainly through the first three or four products. The construction should be complete by Q2 and we’re looking forward to the start-up of the building some time at the end of Q1 to be done by Q2. On the generic side, requirements were up and down a little bit in Q2 and now it looks positive again for Q3. Currently forecast is for roughly 16 million units a month and despite this increase in output we were able to again reduce headcount by a few due to operational efficiencies and some product mix benefit. After some delays in the API supply of Isradipine we are now ready to start validation, and our plan is to be able to launch before year end. So we’re looking forward to that as well as the things that Carter identified the fundamentals in growth and we hope to continue the increase in all the products. So that’s all I have. Nasrat I’ll turn it back over to you.
Nasrat Hakim
Thank you, Doug. Let me summarize couple of high level points that the stats mentioned already. First the commercial launch preparation. We are upgrading the facility and we’ve purchased multiple equipment including what Doug just mentioned, a fluid bed that increases the capacity by multiple folds. We’ve hired the necessary senior management, our legal [ph] by Dr. Ken Smith; Scientific Affairs, Dr. Jason LePree and Regulatory Affairs, Dr. Sophy Abraham. This new addition is to complement our already existing management team. We have developed and are pursuing different sales and marketing models and that’s one of the reasons I am on the West Coast. Our R&D activities and pipeline are very rich. We have several active R&D projects. With a small company like ours you need to prioritize and not take on too much but we have more than half a dozen that are active. Our focus remains on ELI-200. The ELI-200 had undergone vigorous testing and clinical trials and lab trials this year. We definitely have a successful formulation and technology. We have passed the bio BD [ph] test here bioequivalent. We have placed registration batches on six month accelerated and 12 month room temperature stability. The six month accelerated and nine month have done, the 12 month will come out next months and the data look solid. We filed an IND and we’ve been in constant communication with FDA and receiving feedback from them. Our anti-abuse anti-A guidance [ph] have been implemented, I hope to the satisfaction of the FDA. In vitro laboratory abuse testing was completed and the reports issued. The [indiscernible] study they have studied, category two is completed and category three is completed with excellent results. The FDA have seen quite a bit of the data and the data they have seen they are happy and the rest that we updated on verbally, they have nothing but positive things to say about it, especially on the CMC part everything we presented to them there were an agreement with it. The third item I would like to update you on is our FDA meeting and this will be a very high level update obviously because we have not issued the press release and we have not worked out all the details with the FDA. All the attributes I just highlighted have been presented to FDA in one form or another through the IND or our meetings and everything is positive. FDA has never seen a product like ours before. Therefore we need to negotiate with them what would make them comfortable. I have anticipated that to possibly happen and I have stated before and I will state it again no one can stop us. We are going to get an approval and we’re going to commercialize this product and I’ve always said FDA may delay us by a few months, but they will not stop us and I do believe we are still going on that path. This is why we’re preparing the commercial scale launch, we’re getting the facilities and we’re working very closely with FDA. Before I turn over the phone back to Dave for Q&A I would like to make one more statement about my staff. Our staff at Elite have been exceptional. They have done the impossible. I have been in this business for 34 years. Nobody, no company had ever been able to take an NDA from beginning to end in a year or 1.5 year to FDA for approval. The team has done the impossible. If this was Watson, Actavis, Pfizer or ALZA Pharmaceutical everybody will be patting each other on the back and singing their phrases and my staff worked tangible [ph] unrecognized because we’re demanding from them hard work day in and day out seven days a week. So I’d like to give a shout out to them because they are the ones who have made Elite what it is. Dave we’re open for question and answer.
Operator
Thank you very much. Ladies and gentlemen the floor is now open for questions. [Operator Instructions]. And we’ll take our first question from Scott Dixon [ph]. Your line is live.
Unidentified Analyst
Good morning gentlemen, congratulations on everything. I have a couple of questions. Is the LP deal 1, is that exhausted or still open and where do we stand on the LP deal 2? Carter J. Ward: Lincoln Park Capital, yes the first one was the $10 million equity line and right that has been completed. The second one is the $40 million equity line, which was in April of this year and that is still active, still in process.
Unidentified Analyst
Okay, I was looking and I thought our patent was good through 2033 and I think I saw it’s only good till 2023, did I read that correct? Carter J. Ward: It’s 2023, yes.
Unidentified Analyst
Okay. Why did we hire the three new people were -- are we ready to move forward or do we have some more work that we need to have done for the FDA? I couldn’t hear Nasrat very well, so I apologize.
Nasrat Hakim
My apologies too. As I stated in addition to my accent I have two other disadvantages. I am on the cell phone because I am traveling and I have a sore throat. We hired the additional three employees because our need is we have a lot of products in-house that I’m much sure that sooner or later bring in-house. So let me give you an example. We have 40 employees at Elite. All of our clinical work and clinical support gets done by Camargo, who are fantastic, but also they come at a price, and by clinical organizations all the way from Texas to Canada and again they’re supporting us very well, but they come at a higher price. And now that we have reached a point where we need to commercial we need the best in the industry and I do believe and I have worked Ken Smith before and he is the best in the industry. So we recruited him to join us. So think about this, I could continue on the present model and hire people that I pay them a lot of money or bring in a PhD in Pharmacy like Dr. Jason LePree who could take on some of the work internally and save us a lot of money.
Unidentified Analyst
Okay, thank you. I have one more question if I could please. I know that on a couple of APIs where you have always had problems getting them resolved. Are you already looking at the API issues for ELI-2000 to get them resolved?
Nasrat Hakim
ELI-200, yes, the problem with the APIs and this is an issue that every single company knows whether it’s Pfizer or Actavis. Anytime you are not buying [indiscernible] APIs from a company they usually don’t give you a locked in grade, why because they want the many variability to be able to increase the prices of their gains. We are working very closely now that we have gone commercial with all of the excipients, functional excipients and API manufacturer to come out with some kind of an age contract that that cannot happen for a few years.
Unidentified Analyst
Okay, very good. I think that's all I have for now. Good job and keep up the great work guys. Appreciate it.
Nasrat Hakim
Thank you, Scott.
Operator
Thank you. We’ll take our next question from Bob Parker [ph]. Your line is live.
Unidentified Analyst
Good morning. Just a couple of questions myself. On the FDA meeting that was held was this the first meeting with them, at our last conference call was forecasted would occur in October?
Nasrat Hakim
That is correct. There are two types of meeting we hold with FDA. There are answer and question meetings where they commit to give you a question within a certain time if you don’t meet with them in person and there is the face to face. In October they gave us responses in writing in November and they agreed to the date on the 17th which was the one where we were face to face. So both of them did take place each one is at a different floor.
Unidentified Analyst
Okay. And you had mentioned there will be a news release to get more detail on Monday’s meeting do you have estimate when that would come out?
Nasrat Hakim
I can’t give you an exact date because I’m not on Elite time, I am on FDA time. As soon as the FDA notify us that what you are doing is acceptable to them or they need something else from us, sorry guys, till we have that clarity in writing I can’t do that.
Unidentified Analyst
Okay. My last question shifting gears a little bit is over to the Hong Kong partnership. Can you expand or give more details of who that might be and what’s being worked on with them?
Nasrat Hakim
Somebody from my staff can do that. Carter J. Ward: Yes, well I mean to answer your question we have the confidentiality agreements in place. So we’re not at liberty to say the name of the product or the name of the company. The -- generally what happens when you’re developing a pharmaceutical product you don’t announce the product for strategic reasons, you don’t want to let the market and the competitors know that you’re working on it and who is working on it. So from a competitive standpoint that’s standard procedure and plus there is a confidentially agreements in place to protect that as well.
Unidentified Analyst
Okay. Is there an estimate of where this product at what point that would be released or would come out? Carter J. Ward: Well generally once public filings are made with the FDA and there is approvals received, that's when it becomes publicly known that’s when things are -- a press release will go out, something like that, but until such time it’s very important to keep this information confidential for competitive reasons.
Unidentified Analyst
Okay, all right thanks gentlemen. Carter J. Ward: You’re welcome Bob.
Operator
Thank you very much. We'll take our next question from James Smith [ph]. Your line is live.
Unidentified Analyst
Good morning, thank you very much. You guys did a great job and my hats off to the staff as well for all their hard work. My question is to follow up with you on the ELI-200. I kind was going in -- I was kind of going in and out with the phone, what are we looking at time wise realistically before we think we have the approval from FDA?
Nasrat Hakim
This will depend on what we negotiate with the FDA. I can only give you my person view and personal guess.
Unidentified Analyst
Okay.
Nasrat Hakim
I think approval they have stated in one of their correspondence with us that they will give us expedited review. So I assume that’s going to be eight month. Usually it’s six by letter of the law, but I know that there is some things, some work which gets happens before and some work happens after. So it’s in something about eight and I am being generous when I say eight as I said it’s six by the letter of the law. So from the time they accept the filing within eight months from then we can launch.
Unidentified Analyst
Okay. And as follow-up on that sir when are we looking that we will be able to finally file everything?
Nasrat Hakim
Trust me we’re ready to file next month, but we are not in such rush to file with the FDA and they come back three or four months later. We really wanted to do this one little thing but it will take three four months and end up delaying this badly. So we are waiting for the FDA and they promise expedite things to give us a clarity on what’s acceptable and what -- I shouldn’t say what’s not acceptable because everything has been acceptable to them. It’s the fact that they have never seen any product like ours before and they may ask us for some enhancements or couple of extra things and I can just say to you guys and update you guys on it before and once they make that decision that really will set things in motion but it just are facts [ph] that will happen one after the other.
Unidentified Analyst
Great, thank you very much. You guys are the best.
Nasrat Hakim
Thank you.
Operator
Thank you very much. We’ll take our next question from Charles Youngblood [ph]. Your line is live.
Unidentified Analyst
Yes, hello, I just wanted to get a clarification on Isradipine. Do you say year’s end or fiscal year’s end?
Nasrat Hakim
Calendar year’s end.
Unidentified Analyst
Calendar year’s end, okay. And also another question in regards to the recent hires, it just seems like as far as communications with shareholders has been somewhat limited and I know there is a lot going on, but I was just curious it doesn’t seem like there is anybody there that really enjoys the PR portion of the business. Was there any thought to hiring somebody to handle PR for the company?
Nasrat Hakim
Well, first we do have Dianne who has been with the company for years and she is one of the most knowledgeable about the company and its history. And second, believe me I have heard the statements you made before and I don’t know where it’s coming from. We are on the bulletin board we are a [indiscernible] company yet we hold meetings religiously with you guys. I did presentations [ph] also to the industry, we update you on everything that we have and we don’t have a ton of money, where we have a few million dollars so we will not -- we are much better shape than we’ve ever been but we cannot execute on hundreds of projects and these projects take time. Just to give you a simple example on the in vitro test one sub part of this big picture and my staff Dr. LePree and four extra employees we hired, two support and two permanent in conjunction with that and then associates took nine months or eight months to execute on the FDA’s requirement of trying to mimic what a person who wants to abuse our product will do by using household items, using the acetone that the wife may have to remove her finger nails with acetone or using alcohol that somebody may have or even Coca Cola; 17 different household items and 1,600 samples later for us to finish one little sub part. So when we update you we started everybody wants the news and we are working on it for months and months and months till we finish and get it acceptable to FDA. The amount of information that’s coming out of Elite, especially since I’ve taken over a year ago is mindboggling. [indiscernible] all the updates we have shared for the past year. We are sharing reviews just about everything we can without taking over the law on many times and bringing it you guys my personal assessment at a risk of this is what I believe that we are going to do because we are really an open book to our stockholders.
Unidentified Analyst
Well, and just looking at back at 2014, there have been in conference calls a few times where dates have been put out for approximations when the generic transfer is going to be completed, I have spoken to Dianne not that long ago and she mentioned that it can take up to 10 months for a generic transfer. That was the first time I heard that, I don’t know if that’s true, but we were -- it just seems that we’re under impression that it was going to happen a lot sooner than it has. The FDA meeting was to happen in October. That was supposedly on Elite’s time, but here we are November 17th that we’re meeting with the FDA and it just, it gives impression that over promising and underperforming and I know that there is a potential for big things to happen, but it just seems like getting the handle on the PR and being able to give us more concrete information just seems to be a little lacking?
Nasrat Hakim
So let me answer that one and then we’ll move on. This is what happens, when you’re an open book and share too much with your stockholders. As we are going along and we’re sharing with you our anticipation and our date that we set, when the FDA comes back and changes that for the face to face and makes it November the stockholders are disappointed. So my option are to do one of two things, either not notify you guys that we have false information or start to under promise and over deliver and day begins [ph] with a lot of people in the industry. And I have to be myself, I don’t know how to do that. The second thing is CBE-30, this change being effective in 30 days. When you file that with the FDA, you are on FDA time. The FDA has approved Phendimetrazine within 30 days and approved the CBE-30 for naltrexone in two and a half years. So we don’t know what to tell you as such with the averages in the industry. Sometimes it takes a lot longer on the FDA time and we actually have no control over.
Operator
Thank you very much. We’ll take our next question from Mark Garson [ph]. Your line is live.
Unidentified Analyst
Yes, hello, thank you so much for all that you’ve done Nasrat and Jerry and everybody else, I appreciate, a long time shareholder. Quick question, I believe in the last conference call you mentioned the LPC deal number two that you were going to use it very sparingly because the price of stock was so depressed and now we’re lower. Just wondered if you could comment on using LPC number two and again I am not opposed to it at all because I’m excited, I think that even if the company uses all of their shares, I’m pretty excited about the potential with the products that you have. Carter J. Ward: Okay, well the purpose of the Lincoln Park equity line is primarily in pretty much exclusively to support the development on the opioids, especially, the ELI-200 which is our top priority. So as I go through my presentation and I am really focusing on the fact that we have the resources in place to finish this development, the cash is there, the inventory is there, all of the resources and the critical mass is there and that came from the Lincoln Park transaction. If you look at our equity statements of the $40 million we’ve drawn around $6 million, out of that $40 million. So and that’s exclusively dedicated pretty much to this development. So we are managing it. We are using it for the purpose that we needed and it had a tremendous effect. The fact that we’re able to get everything done in such a short timeframe is in large part due to us having sufficient finance in place. So in that regards the Lincoln Park is critical in our efforts.
Unidentified Analyst
Got you, well I appreciate you guys all the work that you’ve done. Thank you. Carter J. Ward: Thank you, Mark.
Operator
Thank you. We’ll take our next question from Peter Francolin [ph]. Your line is live.
Unidentified Analyst
Hello, Nasrat?
Nasrat Hakim
Yes, Peter go ahead.
Unidentified Analyst
I’m sorry. Just want to say thank you to everybody and I’m pleased with the progress, but would like to ask a question. Number one, you mentioned that you got fast track approval. So fast track approval meaning if and when we file the NDA for ELI-200 it gets expedited review, is what that means?
Nasrat Hakim
That is correct.
Unidentified Analyst
Okay, and that being said, I’m not familiar with what happens, once it’s filed and the NDA is filed, is there things during the review process that can totally eliminate this from getting to market or is it something that they would need something else? What is the down flow once an NDA is filed?
Nasrat Hakim
That is the forward-looking statement, so I’ll share with you my experience. If you file a bad NDA, the FDA will give you a refusal [ph]. If the FDA asks you for certain things and you don’t do them because you disagree with them or you think they are scientifically, they are not justified the FDA will refuse your application. So the smartest thing to do is what you’ve been doing, you open what’s called IND and through the IND you communicate with them back and forth. You send them letters, this is what I’ve done, does the FDA agree? They’ll come back with yes or no, or we agree, but we want to do something else. And you adjust all of that to get to the point where you need to file the final NDA. You meet with them face-to-face and go through a list. Here is what I’ve done, here are my teams [ph], here are my results and they’ll come back with yes we agree you everything is fine. We need one more thing; everything is not fine number fine, number five we need you to repeat it. That feedback would determine the final filing. Once you file the NDA you really should have communicated with FDA enough so you’ll not to get a refusal and that is what we’re trying to do and that’s why we keep communicating with them and having all of these meetings, either what they call a correspondence meetings or face-to-face meetings.
Unidentified Analyst
Okay, finally I met you in the spring at one of the meetings and the big question I guess everybody is waiting on, do you have any confirmation on the -- could we need efficacy trial or not for this particular NDA that we’re trying to get pushed by December?
Nasrat Hakim
And that is the subject that I have mentioned many, many times to everybody before. I am going by the letter of the law and we have done everything that we believe the law requires. The FDA keeps coming back that they may want to see an efficacy and that’s what we’re negotiating with them. If they do and as I’ve said I have anticipated that they may ask for it, [indiscernible] there are certain things I may or may not ask for. And if they do that is what I have said, they will delay us by a few month but they will not stop us because everything else we’ve done has been to their liking. And frankly, we are in the opioid business and everybody knows opioids have been efficacious for 100 years. So it’s not a matter of you are going to say it’s my opinion again, it’s a matter of going through the motions. So if they want us to go through the motion for one more thing we will do it and we will do it right and we will this approval. And the great news for Elite is that once we complete this first product, the ELI-200 and that’s why I’m focusing on it, once we complete it then we know exactly what the FDA wants with all the other products. So we start to go after them without having to wait for FDA to tell us as we have already answered the questions for the first one. That’s why the first one takes longer and it’s the hardest. Once we establish the criteria we’ll move forward tucking things with all the others.
Operator
Thank you very much. We'll take our next question from Jeff Sanders. Your line is live.
Unidentified Analyst
Good morning and congratulations. Just I think you guys are true stewards of shareholders’ interest and I’m glad to be on-board. Just a quick question, can you shed some light on the DA, the DA proposed reclassification of opioid pain killers and how that impacts the commercial landscape overall and specifically opportunities for ELI-200?
Nasrat Hakim
Well that’s a very good question. And it doesn’t affect us today but it will affect us in the future. So let me give you a high level answer since this affects my former company and our other [indiscernible] expansion today. The DA and FDA decided to upgrade couple of products that were class three to class two. What that means is for example for my former company, Watson Pharmaceutical, that makes about $0.5 billion worth of narco products, narco is Hydromorphone [ph] 8 mg, that they were able to store in a cage. A cage is a simple little structure that you have a see through with a little lock into a wall which is extremely expensive, meets the approval, costs a lot of money, have a lot more built on what sold, and this is only on site and then the transport in addition to the doctors. The doctors could not write an open prescription. Now they have to write the prescription for limited time. So this made it very hard for a lot of companies to manage the class 3s. What Elite does it fits to class 2 and this one of the markets that we are interested in and sooner or later once we get the first product in we're going to throw our hat in the ring and hopefully capture some of the market. As I said that this is a long term view, we are set for it. We have the folks, we have the infrastructure for a class 2 and it’s something that we can capitalize on in the future.
Unidentified Analyst
And with that I mean you must be seeing a lot of potential interest from larger partners on the technology just given kind of the recent press on opioids. Can you shed any light on that?
Nasrat Hakim
I am sorry, I am on the cellphone. You broke up, I didn’t understand you.
Unidentified Analyst
Just in terms of collaborations with, I don’t know specific manufacturers of opioids, can you comment, have you seen any recent like surging interest in your products to have a joint JV potentially?
Nasrat Hakim
Well, there have been from day one and I have mentioned this before. I've had Chairmen and CEOs from other companies come and see me, people I have never met before, even though I have been in the business for 34 years, have come down to Elite and have been interested. There is no shortage of that. The issue to me is the right deal, okay. I am not sure that I’ll at it myself and have it to [ph] somebody that wants too much or wants to own as part of our technology as a result of that. I think we are going to make it regardless and one of the models that we have is to partner with somebody others, we got the money, we got the learning part, we’ve got your guys support and we can go at it by ourselves.
Unidentified Analyst
Okay, great. Well good stuff and all the best guys. Thank you.
Nasrat Hakim
Thank you.
Operator
Thank you very much. We'll take our next question from Stanley Goldberg [ph]. Your line is live.
Unidentified Analyst
Good morning Nasrat. I have a couple of comments that I’d like to make not only to you but to all our stockholders which I am one of them. Number one I want to congratulate you in turning Elite into what I feel is a real company, that's number one. Number two is I want everybody to really realize that the upper management that you've brought into place would not have come to Elite, number one without you, but number two, which I feel is more important that they actually see a real company out there, with goals in mind, that everybody is going to benefit by this. Number three is your honesty in answering questions to all investors and the last one really is that is if all investors could be patient this company could be worth a lot more in the future than it is today. So those are my comments.
Nasrat Hakim
Thank you, Stan. I really appreciate that. It’s stockholders like you that keeps us going and as to what a large area [ph], this is why we brought in a giant like Ken Smith and Dr. Jason LePree, because we are establishing a viable company. I am now getting Elite to a point where we will start to achieve. I would like us to take Elite to its solution and I think we have a good future.
Unidentified Analyst
Thank you very much. Keep up the great work.
Nasrat Hakim
Thank you, Stan. Carter J. Ward: Thanks Stan.
Operator
Thank you very much. We'll take our next question from Steve Armstrong [ph]. Mr. Armstrong, your line is live.
Unidentified Analyst
I am sorry, can you hear me?
Nasrat Hakim
Yes, go ahead.
Unidentified Analyst
Are you there, I am sorry?
Nasrat Hakim
Yes, Steve we're here, go ahead.
Unidentified Analyst
Okay. Thank you. Couple of the callers have already addressed some of the things I was going to talk about but I thought I would shift gears, to just ask about the meeting on Friday at the FDA. Could you take us through a little bit about the procedure of the meeting at the FDA, how much time do you spent with them, what the attitude from the FDA was, i.e. did they approach you product as if from a standpoint of a glass half full, with glass half empty, just a little bit of the ongoing discussion, how the meeting takes place and what took place at the meeting.
Nasrat Hakim
Thank you, Steve. I heard about half of what you said because I’m also on a cellphone. It was a little bit itchy, the second part sounded a little bit. So I'm going to try and address that and then maybe my staff can help out a little. I was present at the meeting. It was a standard meeting with the FDA. We were represented by myself and Chris Dick and several of our employees on the line. With us was Camargo and many of their employees on the line and in person also, [indiscernible] for clinical and associate Dr. Headcomb [ph]. So literally I was told that we have a full up house, that top companies don’t bring in as much persons as we brought into this meeting and these are the ones that have [indiscernible]. The FDA’s attitude was positive, there were very complimentary on the CMC section, they were very agreeable. They were really trying to do the right thing. We've asked important questions, they answered what they could and others they said well, we need to think about it together. I felt that they want to help us get the product to the market, but again they want to make sure because this is a first of its kind, that they are comfortable or maybe a little bit even conservative in getting us there. But I did not feel that they want to delay us by a long period of time and I feel they are thinking they will let us through either they are putting us at the similar pace or the same pace they put for [indiscernible] or Pfizer, which is to give us the extraneous review on what could happen in this envelope [ph]. Thanks.
Unidentified Analyst
Thank you very much.
Nasrat Hakim
Have a nice day. Thank you Steve.
Operator
Thank you very much, ladies and gentlemen. The last question we'll take for today is coming from John Sveriza [ph]. Your line is live.
Unidentified Analyst
Hello. My question is, you obviously have already answered it, but I was wondering are you no longer looking for a partner.
Nasrat Hakim
I am looking for what works in Elite’s best interest. Believe me I am one of the few people in the world that you will meet that I don't go anywhere and say hey, this is my four wheeler and it's my way or the highway. If I get a partner tomorrow that is going to do better for Elite then I am doing in sales and marketing development then I think I will all over it. To-date the partners that have seen, one is more than I am willing to give them a few shares of mine. Okay, so yes I am still looking. If I find the right partner I’ll let you know, if not we have alternatives. And thanks for you guys voting for the Lincoln Park and for the work that we have done, we could do it, either way we can do it.
Unidentified Analyst
Okay, thank you.
Nasrat Hakim
Thank you John.
Operator
We've got no further questions in queue. I'd like to turn back the floor to your host for any closing comments they would like to make.
Nasrat Hakim
Okay well, thank you Dave. And thank you ladies and gentlemen for joining us. We will have these really wonderful discussions. I just want to you all to know that we are doing what we believe is in your best interest. There is nothing that we can get for -- there is no way that we can get something for nothing. Clinical trials are very expensive, they require a lot of hard work, they require [ph] that we establish a viable pharmaceutical company, they require money and this is exactly what we are doing. What we have achieved in the past year if you know anything about pharmaceutical business you would go wild. It is extremely impressive and we are going to continue through 2015 during the same great job we've done for you in 2014. Have a great day and thank you for calling.
Operator
Thank you very much, ladies and gentlemen. This concludes today's presentation. You may disconnect your lines and have a wonderful day. Thank you for your participation.
Nasrat Hakim
Thank you Dave.