Elite Pharmaceuticals' CEO Discusses F4Q 2013 Results - Earnings Call Transcript

Jun.24.13 | About: Elite Pharmaceuticals, (ELTP)

Elite Pharmaceuticals, Inc. (OTCQB:ELTP) F4Q 2013 Earnings Call June 24, 2013 11:00 AM ET

Executives

Jerry Treppel - Chairman and Chief Executive Officer

Carter Ward - Chief Financial Officer

Analysts

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 or any comments following the main presentation. (Operator Instructions).

Before management begins speaking, the company has following statements. This conference call contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects if any on future results, performance or other expectations that may have some correlation to the subject matter of this conference call.

Listeners are cautioned that such forward-looking statements involve risks and uncertainties including without limitation, 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 under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the company's ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.

With that covered, it is now my pleasure to turn the floor over to your host, Mr. Jerry Treppel, Chairman and Chief Executive Officer of Elite Pharmaceuticals.

Sir, the floor is yours.

Jerry Treppel

Thank you. Our first speaker will be Carter Ward, our CFO.

Carter Ward

Thank you, Jerry, and thank you, Kate. Also, thanks to everyone for calling in today and for their interest in Elite. On Friday, we filed our 10-K Annual Report for the fiscal year ended March 31, 2013, and a related press release. Hopefully, you all have had a chance to review this by now. If not, the copy can be obtained by contacting Dianne Will at 518-398-6222, or by viewing it at our company's website which is www.elitepharma.com, and it's under the Investor Relations section.

I also want to point out that we filed our 10-K, 10 days earlier than its due date. There's a lot going on in Elite right now and we are trying our best keep our shareholders informed. So, while the Annual Report is much more detailed than our quarterly reports and it also required a full audit, we dedicated ourselves to getting this report done as quickly as possible and we were able to get it out 10 days earlier than usual.

So, I'll be starting this call with an update on the company's operations and then review of the financials. After that, Mr. Jerry Treppel, Elite's Chairman of the Board and Chief Executive Officer will provide his comments and we'll open up the floor for questions at the end of the update.

So, let's start with an update on our commercial operations. Elite now manufactures seven commercial products and we are launching additional product Naltrexone hydrochloride shortly. Of these eight products, five are approved ANDA's owned by Elite, which are sold by tiny pharmaceuticals. Two are products that elite manufactures on a contract basis and one is an OTC product, which was developed and distributed by ECR Pharmaceuticals.

Now, when looking at our product line on the market, it's important to remember that the oldest product of the Phentermine tablets was launched barely two years ago. Of the eight products in our current line, three of them were not even shift during the period covered by this 10-K and therefore had no contributions to the revenues. Four of the products were launched either during this year itself or at the tail-end of the last fiscal year. And the last, Phentermine tablets is being in its only second year on the market. So, just keep in mind just how new our products are with respect to time in the market.

So, with that being said, our brand new product lines generated revenues for the quarter ending March 31 was $1.5 million. This is the largest quarterly revenue ever for Elite.

I'll go over the financials a little later, but first I wanted to talk about our commercial products.

As I said, we have eight products in our commercial line. They are in the following categories. We have bariatric products, analgesics, allergy, alcohol addiction products. So, first, let me start with the bariatric products. These are products which are used to aid weight loss. Elite manufactures four products in this category. We have Phentermine tablets, two strengths of Phentermine capsules and Phendimetrazine.

Phentermine tablets are Elite's first generic product and they have been on the market around two years. Revenues for this product continue to grow with the last quarter being the highest revenue quarter for this product to-date. An issue with this product though was the higher raw material cost incurred that were mentioned last conference call. These higher costs have had an impact and have reduced profitability and began to negatively impact sales. Unfortunately, we have very recently received some relief on the raw material cost which will allow the product to continue modest growth and profitability for the foreseeable future.

The other two Phentermine products, which are Phentermine capsules of 15 milligrams and 30 milligrams, were launched in April 2013. They are launched after the resolution of the raw material issue that was previously discussed. No revenues for these products were recorded for the quarter ending March 31. Product revenues and also our milestone payment will be reflective in future results. The fourth bariatric product, Phendimetrazine tablets was launched November, 2012, and sales have started to grow this quarter.

The change however will occur with this product. Mikah Pharma has notified Elite that it will transition this product from an Actavis label to a Mikah label and Mikah will begin selling Phendimetrazine product through its own distribution channel. We are awaiting more details on this transition. Sales are continuing through the transition though and we expect this change will eventually be a positive change that will support increased product sales.

Moving to the analgesic category, Elite has two products. Hydromorphone and Methadone. These products are used in pain relief with Methadone also being used to treat heroin addiction. Hydromorphone had its best revenue quarter ever. Timing of DEA quotas and raw material supply have made manufacturing the challenge for this product, but we believe, we now have adequate quota for the remainder of this year so that we can not only maintain current sales, but have some continued growth in sales through the rest of this year. Methadone is the product that Elite contract manufactures for Ascend Labs. Revenues were flat for the March 31st quarter, but recently Ascend has advised us of new contract, which we expect will grow Methadone revenues in the next quarters.

In the allergy product line, Elite has one product currently, Lodrane D, which is an immediate relief OTC product developed with and sold by ECR Pharmaceuticals. Lodrane D has been a modest, but steady product for Elite.

In the alcohol addiction category, we have one product, Naltrexone 50 milligram tablets. This product was approved earlier this year, but the preparation for this launch has taken longer than expected. However, production has been scheduled and we expect to be launching this product through TAGI Pharma in the next few months. There's also a milestone payment, which is due to Elite when Naltrexone is first shipped.

So, that's our current commercial product line. But as you know, Elite is also a developing company and we are working on a pipeline of products for future filing that include ANDAs and NDAs. These are all longer term in scope, but they are an interesting part of our operations and we do get a lot of calls and messages from people expressing interest in this pipeline.

Now the 10-K just filed includes a disclosure that we received our second patent on Elite's abuse-resistant technology which employs innovative pharmacological approach to achieve this resistance. In addition, we expect our abuse-resistant opioid product, which has long commercially scaled up. We expect it to enter human pilot studies later this year.

Those of you have been Elite know that we have been working on this product for quite a long time, so you can imagine how happy we are to finally have a scaled up formulation and should know that the first pilot study is expected to take place in the near-term. It's the first of several trials that are required, so the opportunity is still longer term in scope, but progress is being made and we are moving along in the process.

I would also like to mention the recently established equity line with Lincoln Park Capital. Since the primary use of this line is for development of our products such as the pilot study for our abuse-resistant opioid product. This equity line gives us access of up to $10 million at variable rate based on the trading price of our shares at the time that the funds are drawn. It provides Elite with the critical mass level of financing that has been so lacking until now.

So, as you know, product development takes more than just knowhow. Financing such activities is just as important. In the past, secure the financing has been quite difficult thing for us, but now that we have the $10 million equity line in place, we are able to move forward. And as you can see, we are moving forward. We have two patents already allowed, financing in place, a scaled up formulation and the first pilot study is on the schedule, so we are moving forward. We have the knowhow, and now finally we have the finance.

We are also moving forward on the development of our extended release, combination and antihistamine and decongestant. We filed Citizens' Petition on a comparator drug to use for development of this product and are pursuing other routes for commercialization after not reaching its co-development agreement with ECR. This product which is similar to the extended release, Lodrane 24D, which we manufactured up until 2011, fits well with our expertise and our resources. We expect to continue evaluation and development of this product and the opportunity.

Lastly, I wanted to briefly discuss our financials.

During our last Investor call, I said that our financials reveal sustained growth of our new revenue streams. That was for the December financials. These March financials show that the growth was not only sustained, but it actually increased after December.

On our P&L, we are reporting total revenues for the fiscal year of $3.4 million. That's a 40% increase over the prior year's revenue of $2.4 million. Keep in mind those are annual numbers. Digging a little deeper into the revenues, you will note that $1.5 million of our revenues were achieved during our last quarter alone. It's the highest quarterly revenues achieved to-date by Elite.

Please note that $1.5 million quarterly revenue rate equates to $6 million per year, $6 million run rate. I am not sure we are at that exact level just yet, but there is much to indicate that we are growing our revenues and heading in the right direction. So, while we had record revenues for the March quarter, there are no guarantees we'll continue to have record revenues, but there's a lot of indications that show that we can sustain this type of growth.

So as I said earlier, our current product line is still relatively new. When the FDA removed our Lodrane product along with 500 other products from the market, we lost 98% of our revenues overnight. We had to start from scratch. In less than two years, we launched seven new products and we have an eighth going into production next week for a launch in a few months. These products have gained the market share and are growing. While the margins are lower than those of Lodrane, the gross revenues are now above the Lodrane levels. That means, we have to sell more to generate the profits and we are selling more. An important goal at Elite is for us to achieve overall breakeven operating levels and we are moving closer to that goal.

Moving down the P&L, we had an operating loss of $1.6 million for the year as compared to an operating loss of $2 million in the prior year. That's a 20% reduction in losses, which is pretty good. Again, these are annual numbers. Included in this year's operating loss are substantial increases in FDA fees, more than $220,000 annually, as well as significant HR cost increases for medical and unemployment insurance.

Unfortunately it appears that these higher cost levels are not temporary, they are here to stay. They have taken a noticeable toll on our profitability and cash flows, and it's just something we are going to have to manage.

One last thing to mention in relation to the P&L, and that has to do with our employee levels. In order to support this rapid growth, we have hired manufacturing labs and regulatory personnel. We are now up to 29 employees, while that still makes us a small and a lean company, it's almost doubled the 15 employees that we had around a year-and-a-half ago. So, we are growing our revenues and we are creating jobs. That's still a good thing in our books.

Moving over to the cash flow statement, we're showing a negative operating cash flow of $1.9 million this year as compared to a negative $400,000 for the prior year. Once again, these are annual numbers, and as always it's important to look at the components of operating cash flow. Included in this year's cash flows are increases in receivables and inventories of more than $1.3 million that represents working capital investment, which is required to support our growing revenue streams.

The prior year's cash flow statement shows that receivables and inventories were decreasing by almost $0.5 million. So, when you put that together, that's a $1.8 million swing between the years. More importantly, decreasing receivables and inventories are what happened in stagnant or shrinking companies. These types of metrics which existed last year are related to businesses which are liquidating assets rather than growing assets.

The metrics on our current financials however are those of a growing company. Revenues are up, jobs are being created and the flipside of the strains our cash flow appears due to working capital required for financing the growth. So being able to finance growth is always the challenge for myself as CFO, but it's a better challenge than that of the opposite.

Finally, just wanted to give a brief comment on the Lincoln Park equity line, one of the criteria stressed by Elite's Board while considering the equity line as a source of capital, was that most of the funds be used to finance product development and temporary working capital for growth and not be used to fund [lawsuits] [ph].

In order to comply with the Board's requirements, it's essential that we achieve breakeven operational levels. We're not exactly at breakeven yet, but the growing revenues are bringing us closer and we are all optimistic of achieving breakeven and ensuring that the equity line is used for maximum effect in the development of our product pipeline.

With that now, I would like to introduce our CEO, Mr. Jerry Treppel.

Jerry Treppel

I would like to welcome everybody to our fiscal year 2013 conference call, and to thank especially our employees for all the hard work and I want to emphasize that everybody here works very hard to move this company forward and I think the last fiscal year has been the most dramatic in the company's history in terms of what we've done and I just want to thank everybody.

What I want to do is give shareholders more of a strategic view really of what the company is attempting to do. You know with our press release, with our 10-K, with the conference call now, we want to open up the (inaudible) as it were to let you the shareholders who are the owners of the company get a better look at what's really happening here. Carter - and I am going to focus much more on the pipeline rather than the operational aspects of the business, which I think Carter covered very well.

If ever there was a company that appears to be in the right place at the right time with the right products, I think it's Elite, and you know I have been in this business 30-plus years, so I have some experience from ones to choose from. Opioids is a very big market in the United States obviously, we've indicated our initial product is [research] [ph] and formulation of oxycodone, which is a market approaching $3 billion in the United States. Abuse of that product is a very big problem in this country, and as you've seen, if you have read some of the headlines, obviously we picked that product because it was the biggest market opportunity. I could tell you now that the product that will go into pilot studies later this year is a twice-a-day formulation, which happens to be the same as the one that's currently on the market.

Interestingly enough, I mean for those of you who follow the company, you recognize that we have already developed a once-a-day oxycodone bead, which have been commercially scaled up. I don't think it takes a whole lot of imagination to realize that once we’ve demonstrated that we can develop an abuse-resistant formulation that's twice-a-day it’s not that hard to combine the once-a-day oxycodone bead with a Naltrexone bead and hence you have a once-a-day abuse-resistant formulation.

So, oxycodone actually represents two products for us. The same is basically true for the next molecule that we are working on. There is currently a non-abuse formulation on the market and an abuse formulation on the market, so that one molecule represents two product opportunities for the company, so also right now we have [four] [ph] product opportunities that we are looking at in that space.

You may remember that we had tried to license the once-a-day formulation into the European market and had actually found a willing partner, but at that time we did not have the financial wherewithal to pursue that opportunity. Fair to say that opportunity may get looked at again, just to say that there are opportunities overseas that we had not exploited at all, the European and Asian markets for opioids, there's huge almost for (Inaudible) cancer pain.

So, it’s smaller but it does exist and in terms of their development of abuse-resistant market, they are probably five years behind United States, but we do believe they will get there. And, when they do, we are going to be ready with our products.

Just to elaborate a little bit more on Lodrane. We've disclosed that Hi-Tech, ECR did not choose to license our extended release formulations of brompheniramine and pseudoephedrine (inaudible) use actually okay, because we’re glad to deal with people who are interested in moving the project forward. We are a little bit more advanced just then we took it back. We are in discussions with folks who not only have a greater expertise on those particular products but have the financial wherewithal to move forward, what we are really waiting for is feedback from the FDA. We need to know which referenced product to [run] [ph] trails against and we need to know which pseudoephedrine salt we need to put in the product.

Whatever decision they come up with we can do it, we will do it, but we need to know that. So we will continue to have discussions with our interested party but we (inaudible) to tell us which way to go. But we think that can be a very - it was a very good product, before it was pulled off the market and we expect that it will continue to be a very good product when we re-launch it. So, I just want to remind you (inaudible) for a moment. Elite I think is, fair to say, is under the radar, has been under the radar.

During the last fiscal year, one of our main competitors who had licensed their product to a big name Pharma company, it was announced that their product is still in a limbo. We also know that our competitive product to - that we are developing as they had significant manufacturing problems and they really can't put it on the market at least not yet and I want to emphasize again that the beauty of our system is what we call a plug-and-play system.

Once you have sequestered the Naltrexone bead, and learnt how to scale that up and we have done that, what we're really left with is developing the extended release opioid bead which I want to emphasize is not trivial. Okay. It's a specialized expertise.

It’s not reinventing the wheel every time. That's really the position that our competitors are in. Every time they try and develop one of these abuse-resistant opioid products each one’s use is unique and requires a unique approach. We don't see it that way. We think we have a system where we've done it before. We'll take the particular opioid molecule, develop an extended release formulation. We already have the Naltrexone bead, we put them in a capsule and we have a product. So we are pretty excited here. I hope you can tell that.

With that, I'd open it up for questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Thank you. Our first question today is coming from Steve (Inaudible). Your line is live.

Unidentified Analyst

First and foremost, gentlemen, I would like to congratulate you and the other employees working at Elite on the tremendous job you have done the last few years under extremely difficult circumstances considering the FDA’s removal of the Lodrane extended release products from the market. My question is related to the FDA and Elite’s abuse resistant technology. Given the FDA recently put out its abuse deterrent draft guidelines, and Elite's (inaudible) second ELI-216 patent and that there was interest in Elite’s (NYSE:R) [ph] prior to the second patent, I was wondering if additional pharma companies must have contacted you regarding licensing the (R) [ph] product or technology or additional funding of a full scale trial in discussions and if so how those discussions proceed?

Jerry Treppel

It is fair to say that a number of companies contacted us, are very interested in our approach, but the reality is until you start having some human data you are only going to get so far in discussions. Okay, we're going to have that data.

Unidentified Analyst

Okay.

Jerry Treppel

The only thing I think you should be aware of is that now that we have access to capital, it's not in our self interest to license these products in early stages. I mean, the value accretion curve in pharmaceuticals is very steep.

After we get the data back, do we need to have a meeting with the FDA? I mean the guidelines are there. We know what they are, so we don't have an issue with them. It's not anything we can't do, or you know we need to know exactly what it is you want to see. Now, we think based on the Advisory Committee meetings and a lot of things coming out of the FDA is that they really liked the pharmacologic approach.

And just to repeat for people, the difference between our approach and the approach that is used in OxyContin Endo’s product, they use a physical approach. It's a hard shell product. It is harder to break than what was there before, and when you break it (you get high as a kite) [ph]. Okay? With our product, ours is simple. Okay. You just open the capsule, the beads will spill out. You can crush to your heart’s delight, it’s not going to get hard. It actually, we think the FDA likes that better.

Unidentified Analyst

Any king of timeframe in terms of when we might have the data?

Jerry Treppel

What we can tell you is that it's a small study, doesn't take long to get the data back. We'll not look at the moon at this point.

Carter Ward

Just keep in mind there is multiple studies that are required. This is the first of that.

Jerry Treppel

This is the first of them. You’re just trying to figure out, make sure you don't kill somebody getting the kind of (inaudible) you want. It's really preliminary ones.

Carter Ward

Yes. We are still talking about a longer term scope here, but as you know we are going along the path that’s required.

Jerry Treppel

And the one thing that part of when we spoke to you about the Lincoln Park equity line, is what that did more than anything else was ensure that we have capital to develop a product and the company was going to be around.

When it finally hits the market okay, which you know for a long time was anybody's guess, but that's gone. We will be there, we will develop this product and we are going to be there to enjoy the results.

Unidentified Analyst

Okay. Sounds good. Appreciate your time.

Operator

Thank you. Our next question today is coming from Scott (Inaudible) your line is live.

Unidentified Analyst

Good morning, gentlemen.

Carter Ward

Good morning.

Unidentified Analyst

Well, thank you. I just want to tell you what a great job you guys are doing. I have been an investor for five years, then [following that for] [ph] about six and I really like to thank Chris Dick for all that he has done for the company. I know we appreciate everything that he has done and is he still going to stay on in some kind of capacity.

Jerry Treppel

(Inaudible) Chris is still here as a consultant; we are diligently working to find another person to step into that role and also a person (inaudible) in moving 505 (b)2 products. But we know where Chris lives. He is not going anywhere.

Unidentified Analyst

My next question I like to talk about Novel a little bit if I could; I've seen that you got tax returns from them and something that I can't remember what it was off the top of my head, but did we approach them or did they approach us.

Carter Ward

I think both. There's a dialogue going.

Unidentified Analyst

Okay. So, once that was made did you stop the dead line there as far as how much the company is worth or is it until we sign on the paper that we can add there like new FDA stuff like I have seen the Plan B got approved Thursday, will that be part of our negotiations or it is it a stop once we say let's get together and (Inaudible).

Carter Ward

First of all, just from our financial statement purposes, we have to go through an evaluation and (inaudible) really limited to us saying is it worth less or is it worth the same, so that gap that's what on our financial statements. We're not allowed to make the investment work more accounting wise that is. So, keep that in mind when you look at our financial statements. But, secondly with regards to I guess the value or the future of our investment in Novel there is a dialogue going on and we are working with them and they are working with us and we are seeing what's the best path for both of us as partners in this and, you know, one of the paths is that we remain as a partner and another path is that we sell our shares of the company, but these are just things that are in discussion on an ongoing basis.

Jerry Treppel

(Inaudible) As you can tell we are relatively busy during the year and if you seek to monetize an investment it requires a lot of work, a lot of effort. But then you are trying to figure out the value of a minority position in a private company. In financial terms, that's just not a simple math as there are going to be disagreements along the line between the parties. But does it rip - is it an asset of value to us? Yes. Okay. And at some point, we hope to realize it.

Unidentified Analyst

I know and we discuss this a lot, and one of the things that we'll discuss was do you go by the orange book or how do you come to that final line, so, just there was a meeting of the mind that this is what it’s worth.

Jerry Treppel

The latter.

Unidentified Analyst

I am going to ask you a dumb question and that's all right. Do you have any idea or speculation within $50 million how much it’s worth today?

Jerry Treppel

No. All we could tell you as Carter said, it's not worth less than what it's on the books for.

Unidentified Analyst

Okay. Very good, thank you for answering that. I got another question. Did I hear you right on the API for Phentermine that you got another supplier secured.

Jerry Treppel

(Inaudible)supplier, the supplier that we currently have I think we have managed to convince that the original price point that they chose was counter-productive both for us and for them and they responded accordingly.

Unidentified Analyst

I think I remember on a conference call before or before that that he was working with a second supplier also. How is that coming?

Carter Ward

Not really, I don’t know. No, no. What we are talking about is they being the current supplier we've been in discussions with them and they have lowered their price just based on what the true market value of this product is, which makes us much more competitive.

Unidentified Analyst

Okay.

Jerry Treppel

When they originally raised the price, they made TAGI - TAGI is our market (inaudible) it made them unable to beat the market price. I think based on the data that TAGI was able to show them in terms of actual sales that they were (inaudible) what was happening with their sales, I think we are able to convince them you know what your price is too high. You got to do something.

Unidentified Analyst

Okay. Thank you. One more question on the orders. You talk about once you get that first line task in our tracks and they were something the bead for separate. So, on the second one we have, you have to still do human trials on those what steps like a second we go through.

Jerry Treppel

Well, if you are talking about the once-a-day oxycodone, is abuse-resistant, Okay? The simplest thing that and say that we successfully have the twice-a-day on the market. The simplest, easiest thing Peter to is basically demonstrate your once-a-day inspire only.

Carter Ward

Okay. I think we wouldn't have to do clinical with that.

Unidentified Analyst

Good. That's the answer I was looking for. Well, I am going to say thank you to all you guys and continued good luck and I'll let someone else talk. Thank you so much for all you do and it doesn't go unnoticed. Thank you, Scott.

Operator

Thank you, ladies and gentlemen. Our next question today is coming from (Inaudible). Your line is live.

Unidentified Analyst

Congratulations on a great financial quarter and the continued progress as a lead a long time shareholder and I am very proud to be part of this company. Most of my questions that I had thought of have already been addressed during your opening statements the other questions that were asked, but I would like to know given the past and current successes of out of the lead and what leads me to believe inevitably we are going to have successful test and implementation of our products. At some point, it is a lead committee entertain is buyout offers come in for the company or are we going to stay the course and see where it goes and as far as it goes.

Carter Ward

Let me answer by saying that the mandate of management and the board of directors is obviously to make more shareholder value. We will be foolish not to examine when we considered we all reach the board. Okay. Doesn't mean you have to do anything, but I mean you are obligated to look at it.

Unidentified Analyst

Yes.

Carter Ward

That's what we do.

Unidentified Analyst

Okay. My second question. This one probably Jerry. You could probably best answer. Looking at your short, mid and long-term business strategies, any idea when you think the company might be knocking on the door the NASDAQ it in to get back in?

Jerry Treppel

I have said this before. Our goal is to be a NASDAQ company to use institutional quality stuff. That's not obviously not give these occasional (Inaudible). The board does have authority to do a reverse related to.

Carter Ward

We said obviously that we wanted to wait until such time is that there was advancing activities in the company that we present getting caught in that [work]. Historically, we would switch but you the stock Chris it goes back to where it was. Want to avoid that I was. Obviously guys, if we are getting closer to that point.

Unidentified Analyst

Okay. Thank you for your time and once again congratulation on a great quarter and hope it continues.

Operator

Thank you. Our next question today is coming Kenny [McMahon]. Your line is live.

Operator

Mr. McMahon, your line is live. (Operator Instructions).

Our next question today is from [Alexander]. Your line is live.

Unidentified Analyst

One quick question about the human trial. You said we are in the queue. Were you speak in terms of calendar year or fiscal year in terms of the timeframe?

Carter Ward

Calendar year.

Unidentified Analyst

Calendar year, thank you so much. Second question is about the Hong Kong partnership. I know that's held very close to the chest. Is there any implication or expectation of progress with that partnership that could result in any type of monitory implications this year.

Jerry Treppel

Not this yea. No, that's the long-term development product project, so, we are just developing a product and as you know these things are longer term in scope, so I wouldn't say this fiscal year. No.

Unidentified Analyst

Okay. Thanks so much gentlemen.

Operator

Thank you. Our next question today is coming from Michael (Inaudible). Your line is now live.

Unidentified Analyst

Yes. Good morning. I wonder if you wouldn't mind commenting on the fourth notice from the NJEDA bonds.

Carter Ward

Well, we've been in default for around four years now. There has been two types of defaults are going back (Inaudible) the first type of default is having to do with the interest and/or principle payment being made by the restricted cash account that were to maintain. We've utilized that for I think one or two principle payments and interest payments since 2009, every time we utilize the restricted the cash account we have to replenish everything that was taken within six months and we've always done that. Nonetheless, even though we have replenished the amounts, it's still constitutes an event of default and notices issue.

Second type of default is non-payment of principal payments itself. We had requested in the past to use the restricted cash to make those requirements, and I think for the last three years those requests were denied and so principle payments, were not made at all, so those are the two types of default.

Jerry Treppel

As we've been for four years before and we are in constant contact with the trustee. We have occasional, but regular calls with the bonds holders are welcome to call in and occasionally we get questions like this as well. So, it's something that we're disclosing and we are available and we are in discussions with the people.

Carter Ward

Just to reiterate, we are current on the interest payables.

Jerry Treppel

Yes. We fared on the interest payments. Interest payments is for the bottom holders have been receiving their interest payments on the dates due without fail, so that's not principle things.

Operator

Ladies and gentlemen, (Operator Instructions). Thank you. Our next question is coming from [Matthew Davis]. Your line is live. Davis, your line is live.

Unidentified Analyst

Sorry. I was muted there. First, I want to congratulate you guys on the terrific quarter and outstanding year and remarkable turnaround over these past 18 months or so.

I did have questions on a couple of the other products that I know are in the queue such as the ANDA that's pending approval now that is developed and housed by Elite, also curious if there is any additional information you can provide on the products being developed with Hi-Tech as well as with Mikah Pharma.

Carter Ward

As far as the ANDA that's pending. Well, actually there are two. One was developed solely by the Elite and I think the estimate I have as to when that might get approvals by the year. There's also NDA pending from the institutional items. I am not sure what the timeframe is on that, but we gain 15% share, particularly in that.

Jerry Treppel

Just keep in mind that the product that we have filed, we generally don't as a policy disclose those products until after they've been approved. And, just for obvious competitive reasons. We are still working with the Hi-Tech on development work. We do what they ask and timeframe [financer] for Hi-Tech. And what was the other question?

Unidentified Analyst

The Mikah product.

Jerry Treppel

The Mikah product, same thing. It's on schedule. It's in development and these are the types of things that we really don't make announcements until we have something concrete to announce, but we are working on it.

Operator

Thank you. Our next question today is coming from [Brian]. Your line is live.

Unidentified Analyst

Thank you very much for a good quarter here and want to echo everybody else's sentiments so just keep up the good work. My question is specifically for Jerry, with the Jerry triple line of credit turning due in July 31, how are we going to plan on paying those bells off?

Jerry Treppel

Well, Elite is not. I have not asked them to.

Unidentified Analyst

Will there be an amendment and an extension?

Jerry Treppel

Well, since I am the.

Carter Ward

Line of credit.

Carter Ward

I mean, could we do want it? Yes. Right now, there's paying me interest. It's pointless. I want them to use the monies they get from weaken part to go with the products. Those are either company or (Inaudible) you owe me $600 million, sometime I have thought about and a point in future that line is thoughtfully honest with you? We'll see how that goes, but there's no hurry to have them repaid it. I'll put that way.

That's a legal reason why we have to follow amendment, obviously we will, but it really comes down to Jerry is the President and has a line of credit. Obviously he's been phenomenal supporting this company and as you can tell it will continue.

Operator

Thank you. Our next question today is coming from [Adam Miller]. Your line is live.

Unidentified Analyst

Could you tell us if you, [John], on the LPC funds to-date?

Carter Ward

If you look at the 10-K, I think in the financial statements there's a subsequent event that discloses that. We have made drawings gross amount of $320,000.

Unidentified Analyst

Excellent. Thank you. And, in talking about that undisclosed ANDA that you are waiting for roughly about or I think is that, this is I guess a humorous question, because could you tell us if that was a single or double or triple or is that a out of the park home run product?

Jerry Treppel

Single for the in-field.

Unidentified Analyst

Excellent. Okay. Thank you very much, gentlemen for an excellent quarter.

Operator

Thank you. We have no further questions at this time.

Carter Ward

Thank you, everybody, for listening to the call. If you have any questions, you can Elite, you can call Dianne. Hopefully will [answer] for you. Thank you.

Jerry Treppel

Thanks everybody.

Operator

Thank you, ladies and gentlemen. This does conclude today's conference call. Cut your phone lines at this time and have a wonderful day. Thank you for participating.

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